WO2016199135A1 - An improved capsule for delivering flowable substance - Google Patents

An improved capsule for delivering flowable substance Download PDF

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Publication number
WO2016199135A1
WO2016199135A1 PCT/IL2016/050592 IL2016050592W WO2016199135A1 WO 2016199135 A1 WO2016199135 A1 WO 2016199135A1 IL 2016050592 W IL2016050592 W IL 2016050592W WO 2016199135 A1 WO2016199135 A1 WO 2016199135A1
Authority
WO
WIPO (PCT)
Prior art keywords
additionally
compartments
capsule
substance
gas
Prior art date
Application number
PCT/IL2016/050592
Other languages
French (fr)
Inventor
Daniel Shahaf
Iris SHICHOR Ph.D.
David Napchi
Original Assignee
Sipnose Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sipnose Ltd filed Critical Sipnose Ltd
Publication of WO2016199135A1 publication Critical patent/WO2016199135A1/en

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    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/0005—Components or details
    • B05B11/0027—Means for neutralising the actuation of the sprayer ; Means for preventing access to the sprayer actuation means
    • B05B11/0032—Manually actuated means located downstream the discharge nozzle for closing or covering it, e.g. shutters

Definitions

  • the present invention generally pertains to a system and method for containing at least one flowable substance prior to delivery. More specifically, the present invention relates to the use of a frangible capsule which can contain a plurality of flowable substances.
  • the capsule is designed so as to ensure proper mixing of the flowable substances with each other and with the entraining gas, so that a properly mixed dispersion of the drugs is entrained with the carrier gas so as to ensure deposition of the flowable substance(s) at a desired deposition site.
  • Flowable substances such as medications are commonly packaged in containers such as capsules, vials or blister packs, with the container being opened at the time of use, and the flowable substance contained therein delivered to the patient, usually to the mouth or nasal cavities.
  • Such containers can additionally contain an inert atmosphere to protect the flowable substance, or the flowable substance can be packed under vacuum, to prevent degradation of the substance during storage.
  • the container is inserted into a delivery device, opened, usually by the delivery device, and the flowable substance is entrained by a carrier, usually a gas, and carried by the carrier to the desired deposition site, usually some portion of the nasal cavities or the lungs.
  • a carrier usually a gas
  • Entrained liquids form droplets which can have undesirably large dispersions in size and, similarly, entrained powders can have undesirably large distributions of particle size.
  • the overall quantity of substance in the carrier is not uniform, either in time or in space.
  • current devices are single -compartment; there is no means of separating components during storage. For multi -component medications, if there are even slow reactions between the components, this can significantly reduce storage time.
  • controller in communication with said activation mechanism wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state.
  • (a) P is in a range of about 2 - 10 barg
  • V is in a range of about 1 - 21 ml
  • said volume rate dV/dT is greater than about 0.001 ml /ms;
  • (g) dT is in a range of about 0 to 500 millisecond; and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
  • said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
  • said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube. It is another object of the present invention to provide the device as defined above, additionally comprising a dose counter.
  • a processor configured to score at least one member of said sensing group according to a predetermined scale
  • a regulator configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
  • said at least one fiowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
  • said at least one fiowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp),
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodon
  • At least one said compartment contains at least one said flowable substance
  • At least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, at least two said compartments have different volumes
  • n of compartments being an integer greater than 1, at least two said compartments have the same volume
  • n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
  • n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area
  • n of compartments being an integer greater than 1, at least two said compartments contain different substances;
  • n of compartments being an integer greater than 1, at least two said compartments contain the same substance
  • n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
  • n of compartments greater than 1 at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule; m. at least one said compartment is at the centroid of said substance capsule;
  • centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
  • the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
  • a database wherein said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
  • V is in a range of about 1 - 21 ml
  • said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
  • said activation mechanism comprises at least one magnet. It is another object of the present invention to provide the device as defined above, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
  • said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
  • a processor configured to score at least one member of said sensing group according to a predetermined scale
  • a regulator configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
  • said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp),
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodon
  • At least one said compartment contains at least one said flowable substance
  • At least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, at least two said compartments have different volumes
  • n of compartments being an integer greater than 1, at least two said compartments have the same volume
  • n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
  • n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area
  • n of compartments being an integer greater than 1, at least two said compartments contain different substances;
  • n of compartments being an integer greater than 1, at least two said compartments contain the same substance
  • n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
  • n of compartments greater than 1 at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule; m. at least one said compartment is at the centroid of said substance capsule;
  • centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
  • controller in communication with said activation mechanism b. activating said device, said activation opening said gas capsule; and c. dispensing said gas through said distal end wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state.
  • V is in a range of about 1 - 21 ml
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxyco
  • cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
  • n of compartments being an integer greater than 1, providing at least two said compartments with the same volume
  • n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
  • n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area
  • n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
  • n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance
  • n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
  • said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
  • V is in a range of about 1 - 21 ml
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxyco
  • cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
  • n of compartments being an integer greater than 1, providing at least two said compartments with the same volume
  • n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
  • n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area
  • n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
  • n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance
  • n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
  • an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; wherein, during dispensing of said predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T; further wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT; further wherein at least one of the following is held true:
  • (a) P is in a range of about 2 - 10 barg
  • V is in a range of about 1 - 21 ml
  • said volume rate dV/dT is greater than about 0.001 ml /ms;
  • (g) dT is in a range of about 0 to 500 millisecond
  • said activation controller in wireless communication with said device is a remote control. It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state
  • said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
  • At least one said sensor configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
  • a processor configured to score at least one member of said sensing group according to a predetermined scale
  • a regulator configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
  • said at least one fiowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
  • said at least one fiowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp),
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N2O), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone
  • said predefined volume comprises a substance capsule removably containable said device. It is another object of the present invention to provide the device as defined above, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true:
  • n of said compartments is an integer in a range from 1 to 10;
  • At least one said compartment contains at least one said flowable substance;
  • at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, at least two said compartments have different volumes
  • n of compartments being an integer greater than 1, at least two said compartments have the same volume
  • n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
  • n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area
  • n of compartments being an integer greater than 1, at least two said compartments contain different substances;
  • n of compartments being an integer greater than 1, at least two said compartments contain the same substance
  • n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
  • centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
  • said device comprising: a. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; wherein during dispensing of said at least one predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T; further wherein said activation mechanism is in wireless communication with a remote controller, such that reconfiguration from said closed state to said open state can be enabled remotely.
  • a. P is in a range of about 2 - 10 barg
  • V is in a range of about 1 - 21 ml
  • said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
  • said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
  • At least one said sensor configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
  • a processor configured to score at least one member of said sensing group according to a predetermined scale
  • a regulator configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
  • said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT, It is another object of the present invention to provide the smart device as defined above, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
  • said at least one flowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof. It is another object of the present invention to provide the smart device as defined above, wherein said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hyp
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp),
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodon
  • At least one said compartment contains at least one said flowable substance
  • At least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, at least two said compartments have different volumes
  • n of compartments being an integer greater than 1, at least two said compartments have the same volume
  • n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
  • n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area
  • n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
  • At least one said compartment is at the centroid of said substance capsule
  • said substance capsule contains a single dose of said at least one flowable substance. It is another object of the present invention to provide the smart device as defined above, wherein said substance capsule contains a single dose of said at least one flowable substance. It is another object of the present invention to provide the smart device as defined above, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
  • said device comprising:
  • an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state;
  • (a) P is in a range of about 2 - 10 barg
  • V is in a range of about 1 - 21 ml
  • said volume rate dV/dT is greater than about 0.001 ml /ms;
  • (g) dT is in a range of about 0 to 500 millisecond
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxyco
  • n of said compartments to be an integer in a range from 1 to 10;
  • cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
  • g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area; h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances; i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance; j. for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
  • said device comprising:
  • an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure
  • an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state;
  • a. P is in a range of about 2 - 10 barg
  • V is in a range of about 1 - 21 ml; c. dT ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, « ⁇ -> 0; and g. dT is in a range of about 0 to 500 millisecond; and any combination thereof.
  • medicaments for smoking cessation medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporos
  • Calcitonin parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P.
  • acetylcholine ACH
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (Asp
  • alfentanil desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxyco
  • n of said compartments to be an integer in a range from 1 to 10; b. providing at least one said compartment containing at least one said flowable substance; c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
  • n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
  • n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area
  • n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
  • n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance
  • n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
  • n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
  • n of compartments greater than 1 disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule; m. disposing at least one said compartment at the centroid of said substance capsule;
  • FIG. 1A-C schematically illustrate devices of prior art
  • Fig. 2 schematically illustrates locations for deposition of substances entering the nostrils
  • Fig. 3 schematically illustrates an exemplary embodiment of a delivery device
  • Figs. 4-8 schematically illustrate embodiments of the medicine compartment of the present invention.
  • Figs. 9-22 schematically illustrate embodiments of devices comprising the capsule of the present invention.
  • the following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention.
  • the capsule in conjunction with a delivery device, is adapted to deliver the flowable substances to a desired location in the body; e.g., to the nasal cavities, but also to the mouth, throat or lungs.
  • One of the main objects of the present invention is to provide a capsule for storing flowable substances such that the flowable substances can remain separate until the time of use, but can be properly mixed at the time of use.
  • the capsule can be used in conjunction with any delivery device adapted to provide sufficient gas under sufficient pressure to enable proper mixing of the flowable substances with each other and with the gas.
  • the propellant gas is air; the substance is mixed with a volume of air in the range of about 5 - 50 ml and compressed before delivery to a pressure of about 1.5 to 10 bar.
  • compressed air carries/entrains flowable substance to the nasal passages.
  • the energy stored in compressed air or gas is used as a carrier to deliver medicament to the nasal cavity.
  • the volume of air being compressed is in the range of the nasal cavity volume. Said volume serves as a carrier of a medicament for better dispersion and more targeted deposition in the nasal cavity.
  • the pressure to which the gas/air (i.e., the carrier entraining the substance) is compressed and the volume of said gas/sir can be fined tuned and tailored to fit the delivery destination (e.g., respiratory epithelium, olfactory epithelium, brain, lungs, pharynx, heart and any combination thereof).
  • the substance or substances is preferably delivered to nasal passages so as to be delivered to at least one selected from a group consisting of respiratory epithelium, olfactory epithelium, brain, lungs, pharynx, heart and any combination thereof through the nasal passages. Delivery of the substance through the nasal cavity enables it to be delivered to at least one selected from a group consisting of respiratory epithelium, olfactory epithelium, brain, lungs, pharynx, heart and any combination thereof through the nasal passages. Substances can be delivered to the middle and upper turbinates, from whence they can cross, via the thin ethmoid bone, into the brain, thus bypassing the blood/brain barrier and efficiently delivering substances, especially medicaments, to the brain.
  • the term 'flowable substance' hereinafter refers to any substance capable of flowing; such a substance can be a granular material, including a gas; a powder; a liquid; a gel; a slurry; a suspension; an aerosol; and any combination thereof.
  • 'capsule' hereinafter refers to a container adapted to contain a flowable substance.
  • the term will also be referred hereinafter as 'flowable substance capsule'.
  • the flowable substance need not be a medicament.
  • 'olfactory epithelium hereinafter refers to a specialized epithelial tissue inside the nasal cavity.
  • the olfactory epithelium lies on the upper top portion of the nasal cavity behind the nostrils.
  • gas' refers to any fluid that can be readily compressed. Gases as used herein include, but are not limited to, air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon. Devices charged by hand will normally use air as the carrier gas. Preferred gases for use with compressed-gas charging are air, nitrogen and carbon dioxide.
  • the term 'channel' hereinafter refers to a passageway allowing passage of a fluid through at least a portion of a mixing mechanism.
  • the channel can be disposed within a portion of the mixing mechanism, forming a closed bore; it can be on an exterior of a portion of the mixing mechanism, forming a groove on the portion of the mixing mechanism, and any combination thereof.
  • the capsule of the present invention can apply a broad range of drugs and materials to the nasal cavity for local effect, deliver a broad range of drugs and materials through the nasal cavity to the systemic circulation, deliver a broad range of drugs and materials through the nasal cavity to the central nerve system (CNS) the brain, spinal cord and associated nerves, and any combination thereof.
  • the drugs to be applied could be, but are not limited to, pharmaceuticals, natural compounds, biologies, hormones, peptides, proteins, viruses, cells, stem cells and any combination thereof.
  • compressed air is used to entrain the flowable substance, enabling delivery the substance to the olfactory epithelium and from there to the brain.
  • the preferred carrier is air
  • the application can be in powder form, in liquid form or in any other formulation known in the art.
  • the substance can be stored in its most convenient form, either as a liquid, an aerosol, a powder, a slurry, a suspension, or a gel, if thin enough.
  • the substance can be stored either with or without a carrier; the carrier can be a liquid, a gas or a powder.
  • the substance is stored without carrier; however, in some embodiments, the substance is stored in a carrier. If stored with a carrier, the carrier can be a gas, a liquid or a particulate powder.
  • the substance as delivered can comprise a powder, a mixture of liquid and powder, a mixture of gas and powder, a mixture of powders, a liquid, a mixture of liquid and gas, a mixture of liquids, a gas, or a mixture of gases.
  • the volume and weight of the substance will be small, enabling easier and more convenient storage and easier and more convenient use.
  • the formulation as stored is on the order of 99% carrier; a given number of doses of a medicament in a formulation without carrier occupies only about 1% of the volume that the same number of doses of the same medicament occupies if the formulation includes a carrier, such as a formulation intended for use in a metered dose inhaler canister.
  • the substance can be packaged to minimize degradation, for example, by packaging it in vacuum or under an inert atmosphere.
  • storage capsule containing the will be a single-use so that a single, controllable dose can be delivered with each use of the device.
  • an inert gas for the carrier for delivery of the medication obviates the possibility of interactions between the user and the delivery carrier; allergies to carriers, especially in medications used for chronic illnesses, is a growing problem.
  • the delivery carrier is in contact with the medicament for no more than a few seconds and more commonly for no more than a few milliseconds, thereby minimizing degradation of the medicament due to interactions with the delivery carrier.
  • the substance will be a medicament.
  • Examples of types of drugs and materials to be delivered to or through the nose are, but not limited to: treatments for allergic rhinitis; treatments for osteoporosis; vaccinations and immunizations; sexual dysfunction drugs; treatments for B12 deficiency; smoking cessation; treatment of gynecological problems; treatment of other women's health issues; general anesthetics; local anesthetics; opioid analgesics; agonist-antagonists and antagonists; antitussives; drugs used in the treatment of motor disorders; antiepileptics; drugs used in affective disorders; antipsychotics (neuroleptics); sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants; treatments for anxiety disorders; skeletal muscle relaxants; treatments for Parkinson's disease; treatments for Alzheimer's disease;
  • Medicaments for treatment of allergic rhinitis include, but are not limited to: steroids, including corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort and Veramyst.
  • steroids including corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort and Veramyst.
  • Medicaments for treatment of osteoporosis include, but are not limited to, Miacalcin, Fortical and Stadol.
  • Medicaments for vaccinations and immunizations include, but are not limited to: LAVIN, and influenza vaccines including FluMist.
  • Medicaments for smoking cessation include, but are not limited to: NasalFent.
  • medicaments which can be delivered include, but are not limited to, calcitonin and parathyroid hormone.
  • Neurotransmitters and neuromodulators that can be delivered include, but are not limited to: acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, and Substance P.
  • ACH acetylcholine
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (As
  • General anesthetics which can be delivered include, but are not limited to: alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N2O), propofol, sevoflurane, Sufentanil, Sublimase, and thiopental.
  • Local anesthetics which can be delivered include, but are not limited to: benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, and tetracaine.
  • Opioid analgesics, agonist-antagonists, and antitussives which can be delivered include, but are not limited to: agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol.
  • Cannabis cannabinoids, and cannabis derivatives can also be delivered.
  • Agonist/antagonists and antagonists which can be delivered include, but are not limited to: buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone.
  • Drugs used in the treatment of Parkinson's disease and motor disorders which can be delivered include, but are not limited to: amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, and COMT inhibitor.
  • Antiepileptics which can be delivered include, but are not limited to: acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin and Midazolam.
  • Drugs used in affective disorders include, but are not limited to: antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate and valproic acid.
  • Antipsychotics which can be delivered include, but are not limited to: chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene and ziprasidone.
  • CPZ chlorpromazine
  • clozapine fluphenazine
  • haloperidol olanzapine
  • quetiapine quetiapine
  • risperidone sertindole
  • thioridazine thiothixene
  • ziprasidone ziprasidone
  • Sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants which can be delivered include, but are not limited to: alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon and Zolpidem.
  • Anxiety disorders and skeletal muscle relaxants which can be delivered include, but are not limited to: alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, and oxazepam.
  • drugs which can be delivered include, but are not limited to: amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, anti ADHD drugs such as Methylphenidrate (ritalin), and anti-autism and anti -autism symptoms drugs.
  • amphetamine caffeine, ephedrine, methamp
  • Alzheimer's disease Treatment of Alzheimer's disease which can be delivered include, but are not limited to: donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulinlike hormone, dopamine agonist and dopamine antagonist.
  • Figs. 1A-C illustrate capsules of prior art intended to deliver medicaments to the nasal passages.
  • Figs 1A and 1C comprise frangible capsules containing a single medicament.
  • the use breaks the capsule by pressure on a mechanism comprising part of the delivery device, and mixing of the contents of the capsule and air occurs when the patient inhales.
  • Fig. IB comprises a vial; the top of the vial is broken to deliver the medication.
  • the pressure to deliver the substance is the pressure of inhalation, which is quite variable, both between patients and between different inhalations by the same patient.
  • Fig. 2 illustrates locations for deposition of substances entering the nostrils.
  • Typical locations are deposition in the lungs after passage through the lower turbinates (240), thereby enabling transfer of the substance across the walls of the alveoli of the lungs; deposition in the mucous membranes lining the nasal passages, especially the lower (240), middle (230) and upper (220) turbinates, facilitating transfer of the substance to the blood; and deposition in the olfactory mucous membranes of the upper turbinates (220) facilitating transfer, via the thin ethmoid bone (not shown) to the brain.
  • the device comprises at least one compartment, and preferably a plurality of compartments, each containing a flowable substance.
  • the delivery device is designed to rupture the compartments such that the flowable substances are mixed with a carrier, preferably air, and delivered to a predetermined deposition site, typically, but not exclusively, in the nasal passages.
  • Medicaments may be supplied as liquids, as powders, or as aerosols.
  • the medicament is supplied in a single-dose capsule.
  • the medicament is supplied in a multi-dose capsule means, the multi-dose capsule adapted to provide a single dose per activation.
  • the flowable-substance capsule has a plurality of compartments.
  • a compartment can contain at least one medicament, at least one medicament precursor, carrier gas, compressed gas, and any combination thereof.
  • the different compartments can contain different medicaments, with the plurality of medicaments delivered to the nostril or other delivery site in a single dose.
  • a plurality of medicaments may be supplied to the nostril in a single injection, with interactions occurring between the medicaments at most during the short time between rupturing of the capsule and delivery of the substances to the deposition site.
  • the capsule can enable combining medicament with formulation solely during the activation procedure, thus eliminating interactions between the medicaments and the formulations prior to activation and release to the nasal cavity.
  • the capsule is designed such that at least two substances will react after rupture of the capsule and prior to deposition.
  • unstable substances can be reliably delivered to a deposition site.
  • rupture of the capsule during the delivery phase enables mixing of the substances and their reaction.
  • the reaction must be such as to occur in at most a few seconds, between the time the capsule is ruptured and the reacted material deposits at the desired site in the body.
  • the delivery process involves at least one step during which at least one separator between at least two compartments in the capsule is ruptured. Rupture of this separator enables the contents of the at least two compartments to mix and react. It is clear that there can be a sequence of reactions, with, for non-limiting example, precursor A mixing with precursor B to form intermediate C, and, subsequently, intermediate C mixing with precursor D to form final product E.
  • FIG. 3 An exemplary and non-limiting embodiment of part of a delivery device is illustrated in Fig. 3.
  • the nosepiece (6), the capsule (21) and the mouthpiece (5) are removable, and the handle (4) pivots about the lower end of the proximal end (3).
  • the piston driver (13) does not comprise a hinge, enabling it to be manufactured as a single piece.
  • Fig. 3 the handle (4) is illustrated in the open position (i.e., the extended position).
  • the capsule comprises a nosepiece (6) and at least one medicine compartment (21) as a single unit, which is removable and replaceable. In some embodiments, this is a single-use unit, where the medicine compartment (21) is not refillable, the unit being discarded after use.
  • the device (21) comprises a cartridge of medicine capsules, with means to replace an exhausted capsule with an unused one. In some variants of this embodiment, the cartridge can be replaced. In other variants, the cartridge is single-use, the nosepiece unit (43) being discarded when the cartridge is exhausted. In yet other embodiments, the nosepiece (43 or 6) and capsule (21) form two units, enabling replacement of either the nosepiece (6, or 43) or capsule (21), as appropriate.
  • the capsule can be single-use, comprising at least one of a substance, a carrier, a compressed gas, a propellant, and any combination thereof.
  • a multi-dose cartridge can comprise multiple capsules, each capsule comprising at least one of a substance, a carrier, a compressed gas, a propellant, and any combination thereof.
  • the capsule can be single -compartment or can comprise at least two compartments.
  • at least one compartment contains a propellant such as compressed air (air compartment).
  • charging is enabled by causing the compressed air to flow from the at least one compressed air compartment into a compressed air chamber in the device, said compressed air chamber fluidly connected to air channel 16.
  • An illustrative example of a method of causing the compressed air to flow from the at least one compressed air compartment into the compressed air chamber in the device comprises a port on the enclosure such that, when the flowable substance chamber is mounted to the enclosure, the port is enabled to fluidly connect the at least one compressed air compartment to the compressed air chamber.
  • Retracting the handle (4) or placement of the capsule in its capsule retainer position (44) causes a piercing means to pierce a wall of the at least one compartment of the capsule, causing the air to flow from the at least one compressed air compartment into the at least one flowable substance chamber of the capsule.
  • a piercing means to pierce a wall of the at least one compartment of the capsule, causing the air to flow from the at least one compressed air compartment into the at least one flowable substance chamber of the capsule.
  • Figs. 4-8 show embodiments of capsules adapted to contain a plurality of flowable substances.
  • the contents of the at least one compartment comprise a flowable substance in the form of a liquid, a particulate, a powder, an aerosol, a slurry, a gel, a suspension, a gas and any combination thereof.
  • the flowable substance can comprise a medicament or medicament precursor, a propellant, or any combination thereof.
  • the propellant is a compressed gas, such as oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
  • the capsule (100) comprises three compartments (130), sequentially disposed along the main longitudinal axis of the capsule, so that the compartments are placed "one after the other".
  • the compartments are preferably hermetically sealed, being separated by frangible walls (not shown).
  • At least one of the compartments contains compressed gas.
  • the gas can be comprised of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
  • the order of mixing or reaction of the flowable substances is fixed, determined by the order in which the substances are arranged.
  • pressure applied to the upstream end of the capsule will rupture the upstream closure surface. This will compress the flowable substance within the upstream compartment (substance 1); the pressure will then rupture the membrane closing the downstream end of the upstream compartment, allowing mixing and/or reaction between substance 1 and the contents of the next compartment (substance 2). This process then sequentially repeats until all the membranes have ruptured.
  • a mixing mechanism as described below, can be provided to provide a final mixing and/or reaction region.
  • Substances which require a minimum of exposure to air can be position in the compartment that is furthest downstream and stored in an inert atmosphere, thereby minimizing exposure of such substances to the air.
  • the number of compartments is between 1 and 10.
  • up to three different flowable substances can be stored; however, more than one compartment can contain the same flowable substance.
  • the compartments are of substantially equal size. In other embodiments, different compartments can be of different sizes.
  • frangible walls separating the compartments and the frangible walls closing the capsule can have substantially the same breaking strengths, different frangible walls can have substantially different breaking strengths, different regions in a frangible wall can have different breaking strengths, and any combination thereof.
  • the compartments (130) are coaxially disposed within the outer tegument (110), with the compartments nested within one another, with the central compartment forming a cylinder and the remaining compartments, three in the exemplary embodiment shown in Fig. 5, each forming an annulus of a cylinder.
  • the compartments have approximately the same thickness. In other variants, the compartments have different thicknesses. In some embodiments, the thicknesses are such that the compartments have substantially the same volume.
  • the compartment walls have substantially circular cross-section, as does the tegument of the capsule.
  • the compartment walls are substantially similar in cross-sectional shape to the capsule walls (for non-limiting example, lenticular walls within a lenticular capsule).
  • at least one of the compartments' walls' cross section differs in shape from the shape of the cross-section of the capsule.
  • At least one wall separating compartments can be frangible, so that the contents of the at least two compartments mix or react before leaving the compartments, at least one compartment can have a frangible membrane at at least one end, and any combination thereof.
  • the capsule (100) comprises an outer tegument (110) enclosing, in the embodiment shown in Fig. 6, n angularly disposed compartments (130) separated by walls (120).
  • n is six.
  • the walls (120) divide the capsule (100) into the different compartments (130); before use, the compartments are preferably hermetically sealed so that there is no mixing of the up to (in this embodiment) six different flowable substances contained therein. It is clear that two or more of the compartments can contain the same flowable substance.
  • the compartments (130) are of similar size. In other variants of this embodiment, the compartments have different sizes.
  • the compartments (130) are substantially equally spaced. In other variants of this embodiment, spacings between the compartments differ. Spacings can be arbitrary, they can be regular, they can follow a pattern, and any combination thereof.
  • the capsule can have any number of compartments; in practice, there will be no more than 10 compartments.
  • the capsule (100) comprises an outer tegument (110) enclosing, in the embodiment shown in Fig. 7, six angularly disposed cylindrical compartments near the edge of the capsule (130) a central compartment (140), and auxiliary compartments (150, 155), thereby enabling storage of, in the exemplary embodiment shown in Fig. 7, up to 14 different flowable substances. It is clear that any pair of compartments can contain either the same substance (or mixture thereof) or different substances (or mixtures thereof).
  • the compartments are preferably hermetically sealed so that there is no mixing of the flowable substances contained therein before use.
  • the angularly disposed compartments (130) and the central compartment (140) are of similar size and have small volumes relative to the remainder of the capsule (150, 155).
  • At least some of the angularly disposed compartments (130) and the central compartment (140) are of different sizes. In some variants, the compartments, taken together, form a large fraction of the volume of the capsule.
  • compartments (130, 140) are of similar size. In other variants of this embodiment, the compartments have different sizes.
  • the compartments (130) are substantially equally spaced. In other variants of this embodiment, spacings between the compartments differ. Spacings can be arbitrary or they can be regular, they can follow a pattern, and any combination thereof.
  • the capsule can have any number of compartments; in practice, there will be no more than 20 compartments.
  • the auxiliary compartments are hollow, containing a flowable substance.
  • at least one of the auxiliary compartments (150, 155) is comprised of solid material, thereby forming part of the structure of the capsule.
  • the central compartment (140) and the central auxiliary compartment (155) are solid, forming a solid central core for the structure.
  • the remaining compartments (130, 150) comprise flowable substance, where, in preferred embodiments, the compartments (130) contain a flowable substance such as a medicament and the auxiliary compartments (150) contain apropellant, preferably compressed gas.
  • the compartments (130, 150) are near the edge of the capsule; in other embodiments, they are at other positions within the capsule.
  • the compartments (130) form slices within the outer tegument (110).
  • some of the slices have parallel sides, while the central slice is wedge-shaped; in other embodiments, all of slices have substantially parallel sides.
  • a plurality of slices are wedge- shaped.
  • the slices are of different widths; in some embodiments, at least some of the slices have substantially the same width.
  • Embodiments of slice-type capsules can have up to 10 compartments.
  • the walls separating the compartments are planar. In other embodiments, the walls can form a curve, either regular or irregularly shaped.
  • the main longitudinal axis of at least one of the compartments can be parallel to the main longitudinal axis of the capsule, it can be spirally disposed it can be at an angle to the main longitudinal axis of the capsule, and any combination thereof.
  • the main longitudinal axes of the compartments can be straight, they can form regular curve, they can form irregular curves, and any combination thereof.
  • the main longitudinal axes can be the same or they can be different.
  • At least part of the upstream closure surface (not shown) and the downstream closure surface (not shown) of the capsule are frangible or otherwise removable, such that, when broken or otherwise removed, the medications can be delivered to the desired deposition site.
  • different portions at least one closure surface have different breaking strengths, such that the different portions can be broken at different times during delivery of the medication, enabling either differential mixing of medical formulations in different compartments or differential delivery of the medications in at least two of the compartments.
  • At least part of the side surface of the capsule is frangible, enabling yet another mixing path or delivery path.
  • the capsules are cylindrical with circular cross-section, as shown. In other embodiments, the capsules are cylindrical with oval, elliptical, lenticular, or polygonal cross-section, with the polygon having at least three sides and preferably not more than 20 sides.
  • the polygon can be a regular polygon or an irregular polygon.
  • the capsules can be spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof. Capsules can form regular shapes or irregular shapes.
  • the compartments have substantially constant cross-section through the device. In other embodiments, the cross-section of the compartments varies in area, in shape, or in any combination thereof.
  • Criteria of the capsule can be optimized to include: ensuring that a single dose of the substance is delivered in its entirety, ensuring that the single dose contains the predetermined amount of the substance, ensuring that the dose is delivered to the desired region of the nose, and ensuring that delivery of the dose causes the minimum possible discomfort to the patient. Any combination of these criteria can be optimized for; each particular combination giving rise to a different embodiment of the capsule.
  • the capsule can also be optimized for ease of insertion into a delivery device, for ease of removal from a delivery device, for stability of the contents during storage, for resistance of the capsule materials to environmental degradation, for resistance to undesired fracture, for reliability of use, for completeness of mixing, for completeness of reaction, and any combination thereof.
  • the capsule comprises a filter adapted to remove from the air at least one selected from a group consisting of particles, particulates, bacteria, viruses, moisture, and undesired gases before the air contacts the user.
  • a filter by preventing unpleasant odors or tastes from reaching the user and by preventing particles or particulates from reaching the user, can make the experience of using the device much more pleasant for the user. By removing bacteria and viruses, infection of the user can be prevented.
  • the capsule contains only a single dose of the substance, the capsule being replaced after each use. In other embodiments, the capsule contains multiple doses of the substance, preferably packed separately, so that the dose is fresh for each use.
  • any embodiment of the present invention and any variant thereof can be used for both for humans (medical use) and animals.
  • any of the devices as disclosed above and any variant thereof can be used for veterinary applications as well as (human) medical applications.
  • the capsule of the present invention can contain and store a broad range of drugs and materials.
  • the drugs to be contained and stored can be, but are not limited to, pharmaceuticals, natural compounds, biologies, hormones, peptides, proteins, viruses, cells, stem cells and any combination thereof.
  • the substance will be a medicament.
  • Examples of types of drugs and materials to be contained and stored can be, but not limited to: treatments for allergic rhinitis; treatments for osteoporosis; vaccinations and immunizations; sexual dysfunction drugs; treatments for B12 deficiency; smoking cessation; treatment of gynecological problems; treatment of other women's health issues; general anesthetics; local anesthetics; opioid analgesics; agonist-antagonists and antagonists; antitussives; drugs used in the treatment of motor disorders; antiepileptics; drugs used in affective disorders; antipsychotics (neuroleptics); sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants; treatments for anxiety disorders; skeletal muscle relaxants; treatments for Parkinson's disease; treatments for Alzheimer's disease;
  • Medicaments for treatment of allergic rhinitis include, but are not limited to: steroids, including corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort and Veramyst.
  • steroids including corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort and Veramyst.
  • Medicaments for treatment of osteoporosis include, but are not limited to, Miacalcin, Fortical and Stadol.
  • Medicaments for vaccinations and immunizations include, but are not limited to: LAVIN, and influenza vaccines including FluMist.
  • Medicaments for smoking cessation include, but are not limited to: NasalFent.
  • medicaments which can be delivered include, but are not limited to, calcitonin and parathyroid hormone.
  • Neurotransmitters and neuromodulators that can be delivered include, but are not limited to: acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, and Substance P.
  • ACH acetylcholine
  • Anticholinergic drugs adenosine triphosphate (ATP), aspartate (As
  • General anesthetics which can be delivered include, but are not limited to: alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N 2 0), propofol, sevoflurane, Sufentanil, Sublimase, and thiopental.
  • Local anesthetics which can be delivered include, but are not limited to: benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, and tetracaine.
  • Opioid analgesics, agonist-antagonists, and antitussives which can be delivered include, but are not limited to: agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol.
  • Agonist/antagonists and antagonists which can be delivered include, but are not limited to: buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone.
  • Drugs used in the treatment of Parkinson's disease and motor disorders which can be delivered include, but are not limited to: amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, and COMT inhibitor.
  • Antiepileptics which can be delivered include, but are not limited to: acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin and Midazolam.
  • Drugs used in affective disorders include, but are not limited to: antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate and valproic acid.
  • Antipsychotics which can be delivered include, but are not limited to: chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene and ziprasidone.
  • CPZ chlorpromazine
  • clozapine fluphenazine
  • haloperidol olanzapine
  • quetiapine quetiapine
  • risperidone sertindole
  • thioridazine thiothixene
  • ziprasidone ziprasidone
  • Sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants which can be delivered include, but are not limited to: alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon and Zolpidem.
  • Anxiety disorders and skeletal muscle relaxants which can be delivered include, but are not limited to: alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, and oxazepam.
  • drugs which can be delivered include, but are not limited to: amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, anti ADHD drugs such as Methylphenidrate (ritalin), and anti-autism and anti -autism symptoms drugs.
  • amphetamine caffeine, ephedrine, methamp
  • Alzheimer's disease Treatment of Alzheimer's disease which can be delivered include, but are not limited to: donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulinlike hormone, dopamine agonist and dopamine antagonist.
  • sequential compartments are combined with any of the longitudinal compartments, as shown in Figs. 5 to 8, thereby enabling more sophisticated control of the order in which flowable substances are mixed.
  • at least one frangible membrane divides the upstream and downstream ends of, for non-limiting example, a cylindrical compartment (Fig. 7).
  • pressure on the cylindrical compartment ruptures the internal frangible membrane, mixing and/or reacting the flowable substances in the upstream and downstream sub-compartments. This is followed by the mixing and/or reaction of this material with the contents of the other compartments, which may similarly have undergone similar mixing and/or reactions.
  • none or more of the compartments can contain pressurized gas, comprising air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
  • the time during which flowable substances can interact can be predetermined, thereby, for non- limiting example, controlling the completeness of reactions and the time during which materials are exposed to air.
  • the system needs no pre-pressurization because at least one compartment of a capsule contains a pressurized gas.
  • the compartment containing the pressurized gas forms a gas capsule fluidly connectable to the at least one compartment containing the substance; the at least one compartment containing the substance being the substance capsule.
  • the fluid connection is formed by creation of an opening in the gas capsule.
  • an opening is formed in the substance capsule at a time substantially simultaneous with the opening of the gas capsule.
  • the substance capsule is not sealed or is opened at a time substantially before the activation of the device and the opening of the gas capsule; in other embodiments comprising a separate gas capsule and substance capsule, the substance capsule is opened substantially after the gas capsule is opened.
  • the gas capsule can be opened by piercing of a membrane, by bursting of a membrane, by removing an airtight seal from a preformed opening, or by any other means known in the art. Removal of the seal can be by sliding a sealing mechanism to uncover the opening, by lifting a sealing mechanism, by rotating a sealing mechanism, by any combination thereof, or by any other means known in the art from removing a seal from an opening.
  • Device embodiments comprising embodiments of activation mechanisms and embodiments of opening mechanisms, are disclosed below. It should be noted that the disclosed combinations of embodiments are not limiting; other combinations of activation mechanism and opening mechanism are possible and are within the scope of the invention.
  • the gas capsule is opened by means of a piercing mechanism.
  • a device (1200) comprising a piercing mechanism is shown in Figs. 9-10.
  • Fig. 9A-B shows external views of the device
  • Fig. 9C shows an exploded view
  • Fig. lOA-C shows section views along the line A-A of Fig. 9A.
  • Fig. 9A shows the device from the side
  • Fig. 9B is a perspective view of the device from the bottom.
  • the device (1200) comprises a nozzle (1240) with a removable cap (1250) at its distal end.
  • the body of the device comprises a distal portion (1230) and a proximal portion (1210).
  • the distal portion (1230) is fixed to the nozzle (1240).
  • the proximal portion (1210) is slidably connected to the distal portion (1230).
  • the removable cap (1250) would be removed before activation.
  • a flange (1232) on the body distal portion (1230) is configured for a user to place his fingers on it and the device is activated by the user pressing the body proximal portion (1210) inward so that it slides distally into the body distal portion (1230). Compressing the device in this manner forces the piercer (1120) into the gas capsule (not shown) and allows escape of the pressurized gas.
  • Fig. 10A shows a sectional side view of the device along the line A-A of Fig. 9A.
  • Fig. 10B- C shows an enlarged sectional side view of the portion of the device inside the circle B, showing the distal end of the body proximal portion (1210) with the distal end of the pressurized-gas capsule (1212) within it, and a piercing mechanism (1220).
  • Fig. 10B shows the device before activation, in the closed position
  • Fig. IOC shows the device after activation, in the open position.
  • the piercing mechanism comprises a hollow tube (1221), open at the distal end (not shown) and closed at the proximal end.
  • the closed end comprises a sharp tip (1223). In the lower portion of the closed tip is an opening (1222).
  • At least part of the tube (1221) sits snugly, slidably and gas-tightly in a guidance shaft (1214).
  • the open end of the tube is in fluid connection with a substance compartment (1242) and the nozzle (1240). For clarity, no substance capsule is shown.
  • the piercer (1120) Before activation (Fig. 10A and B), when the device is in the closed position, the piercer (1120) is in a raised position, so that the sharp tip (1223) is above the top of the capsule (1212) and the capsule (1212) is gas-tight. During activation, the piercer (1220) is forced downward, piercing the top of the capsule (1212).
  • Fig. IOC After activation, (Fig. IOC), when the device is in the open position, the piercer (1120) is in a lowered position, so that the sharp tip (1223) and the opening (1222) are below the top of the capsule (1212).
  • emptying of the gas capsule will be substantially independent of the speed at which the body proximal portion (1210) is moved into the body distal portion (1220), since, in normal use, the opening (1222) will become entirely uncovered in a time substantially shorter than the time needed to empty the capsule (1212) so that emptying of the capsule will be substantially independent of the speed at which the body proximal portion (1210) is moved into the body distal portion (1220), and the emptying time will depend substantially only on the size of the opening and the pressure within the canister. In preferred embodiments, the emptying time will be less than 500 ms.
  • the gas capsule is opened by means of a piston mechanism.
  • the piston is movable by means of a pair of levers
  • the piston is movable by means of a single lever
  • the piston is movable by means of a magnet.
  • Fig. 11A-B, Fig. 12A and Fig. 12C show external views of a device (1300) with a pair of levers, Fig. 11C shows an exploded view of the device (1300), while Fig. 12B shows a section view along the line A-A of Fig. 12A and Fig. 12D shows a section view along the line A-A of Fig. 12C.
  • Fig. 11A shows the device from the side
  • Fig. 11B is a perspective view of the device from the bottom.
  • Fig. 12A and Fig. 12B show the device in a closed position, while Fig. 12C and Fig. 12D show it in an open position.
  • the pair of levers and piston device (1300) comprises a nozzle (1240) with a removable cap (1250) at its distal end. In use, the removable cap (1250) would be removed before activation.
  • the body (1210) of the device is fixed at its distal end to the nozzle (1240) and at its proximal end to an end stop (1305).
  • the shaft of the piston (1320) passes through the end stop (1305) and is rotatably fixed at its proximal end to the proximal ends of a pair of bendable levers (1330), with the distal ends of the bendable levers (1330) bendably attached to the distal end of the body (1210).
  • Figs. 12A and B show the device with a removable cap (1250) closing the distal end of the nozzle (1240), while Figs. 12C and D show the device without a cap (1250), so that the distal end of the nozzle (1250) is open, allowing gas and substance to escape therefrom.
  • the double lever and piston mechanism comprises a hollow tube (1321), open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown.
  • the head of the piston (1320) In the closed position (Figs. 12A-B), the head of the piston (1320) is fitted snugly, slidably and air-tightly in the proximal end of the tube (1321).
  • a portion of the shaft of the piston (1320) fits snugly, slidably and air-tightly in a guidance shaft (1214).
  • the activation mechanism comprises the pair of levers (1330) and the piston (1320). In the closed position (Figs. 12A and B), the levers are bent so that the piston (1320) is at the top of its travel with its head at least partially inside the tube (1321), thereby sealing the pressurized gas within the body (1310).
  • the levers (1330) are pressed inward towards the body (1310), thereby moving the piston (1320) towards the proximal end of the device. This removes the head of the piston (1320) from the tube (1321), opening the tube and allowing pressurized gas to exit the body and pass up the tube.
  • Figs. 13A-B show enlarged sectional side views of the portion of the device (1300) inside the circle C (Fig. 12B), showing the proximal end of the tube (1321) and the distal end of the shaft (1320).
  • Fig. 13A shows the device (1300) before activation, in the closed position
  • Fig. 13B shows the device after activation, in the open position.
  • the head of the piston (1320) Before activation (Fig. 13A), when the device is in the closed position, the head of the piston (1320) is in a raised position, so that it is within the tube (1321), preventing fluid connection between the interior of the body (1310) and the tube (1321). During activation, the piston (1320) moves downward, thereby opening the distal end of the tube (1321) and creating a fluid connection between the interior of the body (1310) and the tube (1321) and allowing the pressurized gas to travel through the tube and through the nozzle and be dispensed.
  • Fig. 14A-B and Fig. 15A show external views of a device (1400) with a single lever
  • Fig. 14C shows an exploded view of the device (1400)
  • Fig. 15B and Fig. 15C show section views along the line A-A of Fig. 15A.
  • Fig. 14A shows the device from the side
  • Fig. 14B is a perspective view of the device from the bottom.
  • Fig. 15A and Fig. 15B show the device in a closed position
  • Fig. 15C shows it in an open position.
  • the single lever and piston device (1400) comprises a nozzle (1240) with a removable cap (1450) at its distal end.
  • the removable cap (1450) would be removed before activation.
  • the body (1410) of the device is fixed at its distal end to the nozzle (1240) and at its proximal end to an end stop (1405).
  • the shaft of the piston (1420) passes through the end stop (1405) and is rotatably fixed at its proximal end to the proximal end of the lever (1430) by means of a pin (1425).
  • the lever (1430) is substantially in the shape of an "L", with a bend in it, so that its proximal portion, which is rotatably attached to the piston (1420), is, in the closed position, approximately perpendicular to the longitudinal axis of the piston (1420) and its distal portion, comprising its free end, is at an acute angle to the longitudinal axis of the shaft.
  • the central or bend portion, where the proximal portion and the distal portion meet, is rotatably attached (1427) to the body such that the lever can rotate about an axis perpendicular to the main longitudinal axis of the device.
  • Figs. 15A and B show the device (1400) with a removable cap (1450) closing the distal end of the nozzle (1240), while Fig. 15C shows the device without the removable cap (1450), so that the distal end of the nozzle (1240) is open, allowing gas and substance to escape therefrom.
  • Fig. 16A-B shows enlarged sectional side views of the portion of the device (1400) inside the circle D, showing the proximal end of the tube (1321) and the distal end of the shaft (1420).
  • Fig. 16A shows the device (1400) before activation, in the closed position and
  • Fig. 16B shows the device after activation, in the open position.
  • the single lever and piston mechanism comprises a hollow tube (1321), open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown.
  • a portion of the head of the piston (1420) fits snugly, slidably and air-tightly in the proximal end of the tube (1321).
  • a portion of the shaft of the piston (1420) fits snugly, slidably and air-tightly in a guidance shaft (1214).
  • the activation mechanism comprises the lever (1430) and the piston (1420).
  • the upper portion of the lever (1430) is spaced outward from the body so that the piston (1320) is at the top of its travel with at least a portion of its head in the tube (1321), thereby preventing fluid connection between the interior of the body (1410) and the tube (1321). and sealing the pressurized gas within the body (1410).
  • the lever is pressed inward towards the body (1410), thereby moving the piston (1420) towards the proximal end of the device.
  • This removes the head of the piston (1420) from the tube (1321), opening the proximal end of the tube and creating a fluid connection between the interior of the body (1410) and the tube (1321), thereby allowing pressurized gas to exit the body (1410) and pass up the tube (1321).
  • the piston (1420) In the open position (Fig. 15C and 16B), the piston (1420) is at the bottom of its travel, with the head clear of the open end of the tube (1321) so that the opening is clear and there is a fluid connection between the interior of the body (1410) and the tube (1321), allowing pressurized gas to exit the body and pass up the tube.
  • Fig. 17A-B shows external views of a device (1500) with a push-button and magnet and Fig.
  • io8 17C shows an exploded view of the device
  • Fig. 18A-B and Fig. 19A-B show section views along the line A-A of Fig. 17A, with Fig. 19A-B showing an enlarged view of the region inside the circle E in Fig. 17A-B.
  • Fig. 17A shows the device from the side
  • Fig. 17B is a perspective view of the device from the bottom.
  • Fig. 18A and Fig. 19A show the device in a closed position, while Fig. 18B and Fig. 19B shows it in an open position.
  • the push-button and magnet device (1500) comprises a nozzle (1240) with a removable cap (1450) at its distal end. In use, the removable cap (1450) would be removed before activation.
  • the body (1510) of the device is fixed at its distal end to the nozzle (1240) and has a pushbutton (1530) slidably attached to its proximal end.
  • the push-button and magnet mechanism comprises a hollow tube (1321), open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown.
  • the closed position Fig. 18A, Fig. 19A
  • at least a portion of the head of the piston (1520) fits snugly, slidably and air-tightly in the proximal end of the tube (1321).
  • a portion of the shaft of the piston (1520) fits snugly, slidably and air-tightly in a guidance shaft (1514).
  • the activation mechanism comprises a first at least one magnet mounted (1526) inside the shaft of the piston (1520) or forming a portion of the shaft of the piston (1520), and a second at least one magnet (1536) attached to the push-button (1530) and, in the open position, substantially surrounding the piston (1420).
  • the body (1510) is made in two pieces (1510A, 1510B) for ease of assembly.
  • the end stop (1520) is a separate piece. It surrounds the push-button (1530) and is fixed to the proximal part of the proximal portion of the body (1510A).
  • the push-button (1530) fits slidably on a guidance shaft (1514) so that, on depression of the push-button (1530), it slides smoothly into the body (1510).
  • the push button (1530) is at the bottom of its travel and the piston (1520) is at the top of its travel with at least a portion of its head in the tube (1321) thereby sealing the pressurized gas within the body (1410).
  • the piston (1520) will not move of its own accord because the strengths of the magnets are sufficiently small, the distance between the push-button magnet (1536) and the
  • log piston magnet (1526) is sufficiently large, and the coefficients of friction are sufficiently large between, respectively, the piston (1520) and the guidance shaft (1514), the piston (1520) and the tube (1321) and between the guidance shaft (1514) and the push-button (1526).
  • the push-button is pressed upwards into the body (1510), thereby moving the push-button magnet (1536) closer to the piston magnet (1526).
  • the removable cap (1450) is configured such that a user can hold the device with fingers on the removable cap (1450) and thumb on the push-button (1530), so that, in closing his hand, bringing the fingers and thumb closer together, he presses the push button (1530) into the body (1410) of the device and activates the device.
  • the second, push-button, magnet (1536) will become close enough to the first, piston, magnet (1526) that the magnetic attraction will overcome the friction forces and the piston will move towards the proximal end of the device. This removes the head of the piston (1520) from the tube (1321), opening the tube, creating a fluid connection between the interior of the body (1510) and the tube (1321) and allowing pressurized gas to exit the body (1510), pass through the tube (1321 and through the nozzle and be dispensed.
  • the piston (1520) In the open position (Fig. 18B and Fig. 19B), the piston (1520) is at the bottom of its travel, with its head clear of the open end of the tube (1321) so that the opening is clear, there is a fluid connection between the interior of the body (1510) and the tube (1321), and the pressurized gas exits the body (1510), passes through the tube (1321) and through the nozzle and is dispensed.
  • Fig. 20A-B shows external views of a device (1600) with an activation controller and electromagnet
  • Fig. 21 shows a section view along the line A-A of Fig. 20A
  • Fig. 20A shows the device from the side
  • Fig. 20B is a perspective view of the device from the bottom.
  • the activation controller and electromagnet device (1600) comprises a nozzle (1240) with a removable cap (1450) at its distal end.
  • the body (1610) of the device is fixed at its distal end to the nozzle (1240).
  • Figs. 20 and 21 show the device with a removable cap (1450) closing the distal end of the nozzle (1240). In use, the removable cap (1450) would be removed before activation.
  • the activation controller and electromagnet mechanism comprises a hollow tube (1321) open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown.
  • the closed position Fig. 21
  • at least a portion of the head of the piston (1620) fits snugly, slidably and air-tightly in the proximal end of the tube (1321).
  • a portion of the shaft of the piston (1620) fits snugly, slidably and air-tightly in a guidance shaft (1614) and at least one electromagnet (1636) is mounted outside of and at least partially surrounding the guidance shaft (1614).
  • the electromagnet (1636) is a part of the guidance shaft (1614).
  • the activation mechanism comprises the at least one magnet (1626) mounted inside the shaft of the piston (1620) or forming a portion of the shaft of the piston (1620), and the at least one electromagnet (1636) mounted outside of and at least partially surrounding the guidance shaft (1614).
  • the piston (1620) In the closed position (Fig. 21), the piston (1620) is at the top of its travel with at least a portion of its head in the tube (1321), thereby sealing the pressurized gas within the body (1610).
  • the activation mechanism can be a button, slider, twist mechanism or other conventional mechanism (not shown) in physical communication with the device (1600) or a remote controller in wireless communication with the device (1600).
  • the magnetic attraction between the electromagnet and the piston (1620) causes the piston (1620) to move towards the proximal end of the device (1600). This removes the head of the piston (1620) from the tube (1321), creating a fluid connection between the interior of the body (1510) and the tube (1321), opening the tube and allowing pressurized gas to exit the body (1610), pass through the tube (1321) and through the nozzle (1240).
  • a remote controller can also be used with other embodiments.
  • Some non-limiting examples include:
  • the lever or levers can comprise a spring or spring-like material and, before activation, be held in a bent position by a catch or other retaining device. Activation of the remote controller releases the catch, allowing the spring lever(s) to relax and straighten and releasing the gas, as described hereinabove.
  • the lever or levers can comprise a spring and, before activation, be held by a catch with their distal end in the closed position, away from the body of the device. Activation of the remote controller releases the catch, allowing the spring to cause the lever distal end to rotate toward the body of the device and releasing the gas, as described hereinabove.
  • the device can comprise a spring or a spring-like region and, before activation, the movable tube can be held in the closed position by a catch. Activation of the remote controller releases the catch, allowing the spring to move the movable tube towards the proximal end of the device, thereby piercing the gas capsule and releasing the gas, as described hereinabove.
  • the device can comprise a spring or a spring-like region and, before activation, the pushbutton can be held in the closed position by a catch. Activation of the remote controller releases the catch, allowing the spring to move the pushbutton towards the distal end of the device, thereby releasing the gas, as described hereinabove.
  • the device can comprise a motor configured, on activation, to move the movable tube towards the proximal end of the device, thereby piercing the gas capsule and releasing the gas, as described hereinabove.
  • the device can comprise a motor configured, on activation, to move the piston out of the fixed tube, thereby releasing the gas, as described hereinabove.
  • the amount of gas and/or the amount of substance deliverable by the device can be altered.
  • the amount of substance delivered can be by changing the type of capsule, for non-limiting example, from a capsule containing one predetermined amount of substance to a capsule containing a different amount of substance, it can be by loading (for non-limiting example, via a syringe) different amounts of substance into a capsule or into a substance chamber, or by any means known in the art for loading a predetermined amount of substance into a substance chamber.
  • the amount of gas can be changed by changing the size of the gas capsule or by changing the pressure under which the gas is stored. Changing the size of the capsule is preferred, since changing the pressure typically changes the delivery characteristics.
  • Fig. 22A-B shows an embodiment of a device in which the size of the gas capsule can be changed and in which the gas capsule (1212) is separate from the substance capsule (not shown), allowing the same device to be used for different substances.
  • Fig. 22A shows an exterior view of the device and
  • Fig. 22B shows a side sectional view taken along the line BB in Fig.22A of the adjustable part of the device.
  • the device comprises a nozzle (1240) and main body (1710).
  • an adjustable section which comprises a removable housing (1760) configured to contain a gas capsule (1212, Fig.21B).
  • the housing and body (1710) comprise matching screw threads (1765; not shown on the housing) allowing the housing to be screwed inward and outward so as to enlarge or shrink the space within. This ensures that, in use, the gas capsule (1212) is held snugly by the housing (1760) and body (1710), thereby ensuring proper operation of the device,
  • the gas capsule in a first step, is opened, allowing mixing of the gas and the contents of the substance capsule.
  • a valve is opened, allowing the gas-substance mixture to exit from the device, as described above.
  • the device comprises a "double tap", where the drug container comprises a tube of predetermined length and relaxed cross-sectional area, with at least one flexible portion.
  • the ends are swollen closed. Opening the valve simultaneously opens both ends of the drug container as well as the gas capsule, thus allowing use of large volumes (without increasing the size of the drug capsule or gas capsule), allowing these embodiments of the SipNose device to work with a capsules with different volumes (small to large).
  • Non-limiting examples of readily-misused substances are analgesics such as opioids, cannabis, cannabinoids and cannabis derivatives.
  • Non-limiting examples of situations where misuse is not unlikely, independent of the substance dispensed, are patients suffering from confusion, who can have difficulty remembering how long to wait between doses (e.g., trying to dose themselves every hour instead of every 5 hours) and who may even have difficulty remembering how many times to dose themselves (e.g., was it once per day or three times a day), or patients who do not fully understand a dosing regimen (e.g., trying to dose themselves 3 times because "if one is good, then 3 is better").
  • a caregiver or medical professional can control the dispensing, with the patient contacting the caregiver or medical professional to request a dose of the substance or the caregiver or medical professional contacting the patient, either remotely or in person, to remind him to place the device in the proper orifice or to place the device in the proper position and then, when the device is properly placed, activating the device or the remote controller so as to ensure that the patient receives the appropriate medication.
  • the medical professional can ensure that the correct number of doses is dispensed, or refuse to dispense if, for example, an insufficient time has elapsed since a previous dispensing.
  • a caregiver or medical professional can allow dispensing of a dose after a predetermined time, with the patient dispensing the dose when he feels it is necessary.
  • a predetermined time For example, for the control of breakthrough pain in cancer, it can be preferable for a patient to dose himself when the pain occurs, but, to avoid overdosing, a minimum time between administrations can be desirable.
  • the device can be automatically deactivated after administration, and reactivated, wither automatically or by a competent person, such as a medical professional or a trained caregiver, after the minimum time has passed.
  • a remote controller can also be useful for a patient, if the substance is likely to be valuable to a thief.
  • the dispenser and the controller can be kept separate, for example, in separate pockets, or one in a pocket and the other in a wallet or purse or hidden in a pouch or belt under the clothing. If, as is likely, the thief takes only the dispenser, it will be useless for the thief because he can not access the contents without the controller.
  • the device comprises a dose controller configured to enable a user to determine at least one of how many doses remain in the device and how many doses have been used.
  • the simplest dose counters are mechanical dose counters that count a "dose used" each time the device is activated. After a fixed number of activations, a device with a mechanical dose counter is deemed to be empty.
  • a simple counter is adequate to inform a user as to how many doses remain available, although such a counter can not determine how much substance has been wasted by, for example, not being removed from a blister during dosing.
  • Dose counters also use at least one sensor or a combination of at least one sensor and a mechanical counter, to determine either or both of doses used and doses remaining.
  • Sensor-based dose counters can measure, for non-limiting example, pressure within a device, the weight of the device, the amount delivered per dose, the gas velocity at predetermined points within the device, and any combination thereof. If the device further contains a database, the amount of each dose can be stored and, at the least, totaled, to give the total amount used and, therefore, the amount remaining.
  • the data are downloadable, so that the variations in delivery pressure, amount used, delivery velocity, and any other stored parameter, can be stored elsewhere, and, as desired, plotted or further analyzed.
  • the device, the capsule, and any combination thereof are "smart", comprising at least one of a controller configured to manipulate data and a communication means such that measured data can be downloaded for further manipulation elsewhere.
  • at least one of the device and the capsule comprises a database configured to store the data.
  • Data can include, but are not limited to, a member of a group consisting of: device parameters such as delivery pressure, delivery time, amount used, delivery velocity, frequency of use, and any combination thereof; parameters of the patient, such as, but not limited to, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof; and any combination thereof.
  • Communication between the system and a remote system is preferably wireless, although wired communication can be used.
  • the system (the device, the capsule and any combination thereof) further comprises processing facilities that enable it to warn a user or a remote medical professional of such things as failure to properly deliver a dose, leakage in the device, a user's having difficulty in properly activating a device, a user's difficulty in following a treatment protocol, drift in device parameters, and any combination thereof.
  • the system comprises a data
  • the smart system comprises means of altering device parameters or of alerting a user, a carer or medical professional.
  • feedback is used to control at least one parameter of device use.
  • the measured data can be analyzed, either locally or remotely, and the results of the analysis can be used to alter either a device operating parameter or to alert a user, carer or medical professional to alter the timing of the doses or the number of doses.
  • Sensors can include, but are not limited to, a pressure sensor, a velocity sensor, a mass flow sensor, a temperature sensor, and any combination thereof.

Abstract

The present invention provides a capsule for storing at least one and preferably a plurality of different formulations of flowable substances prior to delivery. The capsule is designed to ensure proper mixing of the flowable substances during delivery, both with each other and with the carrier gas that entrains them and delivers them t o a predetermined deposition site. The capsule is further designed to ensure complete emptying of the flowable substances from the capsule so that virtually the entire dose is deliverable to the predetermined deposition site.

Description

AN IMPROVED CAPSULE FOR DELIVERING FLOWABLE SUBSTANCE
FIELD OF THE INVENTION
The present invention generally pertains to a system and method for containing at least one flowable substance prior to delivery. More specifically, the present invention relates to the use of a frangible capsule which can contain a plurality of flowable substances. The capsule is designed so as to ensure proper mixing of the flowable substances with each other and with the entraining gas, so that a properly mixed dispersion of the drugs is entrained with the carrier gas so as to ensure deposition of the flowable substance(s) at a desired deposition site.
BACKGROUND OF THE INVENTION
Flowable substances such as medications are commonly packaged in containers such as capsules, vials or blister packs, with the container being opened at the time of use, and the flowable substance contained therein delivered to the patient, usually to the mouth or nasal cavities.
Such containers can additionally contain an inert atmosphere to protect the flowable substance, or the flowable substance can be packed under vacuum, to prevent degradation of the substance during storage.
At the time of use, the container is inserted into a delivery device, opened, usually by the delivery device, and the flowable substance is entrained by a carrier, usually a gas, and carried by the carrier to the desired deposition site, usually some portion of the nasal cavities or the lungs.
Current combinations of delivery device and substance container tend to provide inhomogeneous mixtures of entrained substance and carrier. Entrained liquids form droplets which can have undesirably large dispersions in size and, similarly, entrained powders can have undesirably large distributions of particle size.
Furthermore, the overall quantity of substance in the carrier is not uniform, either in time or in space. In addition, current devices are single -compartment; there is no means of separating components during storage. For multi -component medications, if there are even slow reactions between the components, this can significantly reduce storage time.
It is therefore a long felt need to provide a capsule provide storage of flowable substances that prevents degradation of the substances during storage, prevents delivery of the substances in an inhomogeneous state, and, optionally, enables reactions between flowable substances at the time of delivery, but prevents those reactions before the time of delivery.
SUMMARY OF THE INVENTION
It is one object of the present invention to provide a device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body.
It is another object of the present invention to provide a device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: a. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and c. a controller in communication with said activation mechanism wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state.
It is another object of the present invention to provide the device as defined above, wherein said controller additionally comprises a communication mechanism.
It is another object of the present invention to provide the device as defined above, wherein said communication mechanism is configured to receive a command selected from a group consisting of: a command to prevent said transition from said closed state to said open state, a command to allow said transition from said closed state to said open state, and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising a database.
It is another object of the present invention to provide the device as defined above, wherein said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein, during dispensing of said predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T.
It is another object of the present invention to provide the device as defined above, wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate ofdV /dT.
It is another object of the present invention to provide the device as defined above, wherein at least one of the following is held true:
(a) P is in a range of about 2 - 10 barg;
(b) V is in a range of about 1 - 21 ml;
(c) said pressure rate, ^→ cc<;
(d) said pressure rate dP/dT is greater than about 0.0001 barg /ms;
(e) said volume rate dV/dT is greater than about 0.001 ml /ms;
(f) said predetermined period of time, dT→■ O; and
(g) dT is in a range of about 0 to 500 millisecond; and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising at least one activation controller configured to activate said activation mechanism.
It is another object of the present invention to provide the device as defined above, wherein said activation controller is either in physical communication with said device or in wireless communication with said device.
It is another object of the present invention to provide the device as defined above, wherein said activation controller in physical communication with said device is selected from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation controller in wireless communication with said device is a remote control.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the device as defined above, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state.
It is another object of the present invention to provide the device as defined above, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein at least start of movement of said piston relative to said fixed tube is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
It is another object of the present invention to provide the device as defined above, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
It is another object of the present invention to provide the device as defined above, wherein said device comprises two said bendable levers.
It is another object of the present invention to provide the device as defined above, wherein at least start of bending of at least one said lever is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis.
It is another object of the present invention to provide the device as defined above, wherein at least start of pivoting of said lever is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
It is another object of the present invention to provide the device as defined above, wherein said at least one second magnet is attached to a push-button slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state.
It is another object of the present invention to provide the device as defined above, wherein at least start of sliding of said push-button is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
It is another object of the present invention to provide the device as defined above, wherein said activation controller controls start of energizing said electromagnet.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises at least one magnet.
It is another object of the present invention to provide the device as defined above, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises at least two said magnets.
It is another object of the present invention to provide the device as defined above, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
It is another object of the present invention to provide the device as defined above, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube. It is another object of the present invention to provide the device as defined above, additionally comprising a dose counter.
It is another object of the present invention to provide the device as defined above, additionally comprising at least one sensor.
It is another object of the present invention to provide the device as defined above, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising: a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
It is another object of the present invention to provide the device as defined above, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
It is another object of the present invention to provide the device as defined above, wherein said gas entrains said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas. It is another object of the present invention to provide the device as defined above, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
It is another object of the present invention to provide the device as defined above, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one fiowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein at least one said substance comprises a medicament.
It is another object of the present invention to provide the device as defined above, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
It is another object of the present invention to provide the device as defined above, further comprising a filter, said filter upstream of said at least one fiowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the device as defined above, wherein at least one said fiowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the device as defined above, wherein said at least one fiowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said at least one fiowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (Ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said predefined volume comprises a substance capsule removably containable said device.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true: a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance;
c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
lO h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances;
i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule; m. at least one said compartment is at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane;
o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
It is another object of the present invention to provide the device as defined above, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said polygon has between three sides and 20 sides.
It is another object of the present invention to provide the device as defined above, wherein said polygon is either a regular polygon or an irregular polygon.
It is another object of the present invention to provide the device as defined above, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance capsule, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said substance capsule contains a single dose of said at least one flowable substance.
It is another object of the present invention to provide the device as defined above, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
It is another object of the present invention to provide a device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: a. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and c. a database wherein said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising a controller in communication with said activation mechanism.
It is another object of the present invention to provide the device as defined above, wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state. It is another object of the present invention to provide the device as defined above, wherein, during dispensing of said predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T.
It is another object of the present invention to provide the device as defined above, wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate ofdV /dT.
It is another object of the present invention to provide the device as defined above, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
c. said pressure rate,—→ xs; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, dT→■ O; and g. dT is in a range of about 0 to 500 millisecond; and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising at least one activation controller configured to activate said activation mechanism.
It is another object of the present invention to provide the device as defined above, wherein said activation controller is either in physical communication with said device or in wireless communication with said device.
It is another object of the present invention to provide the device as defined above, wherein said activation controller in physical communication with said device is selected from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said activation controller in wireless communication with said device is a remote control.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the device as defined above, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state.
It is another object of the present invention to provide the device as defined above, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein at least start of movement of said piston relative to said fixed tube is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever. It is another object of the present invention to provide the device as defined above, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
It is another object of the present invention to provide the device as defined above, wherein said device comprises two said bendable levers.
It is another object of the present invention to provide the device as defined above, wherein at least start of bending of at least one said lever is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis.
It is another object of the present invention to provide the device as defined above, wherein at least start of pivoting of said lever is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
It is another object of the present invention to provide the device as defined above, wherein said at least one second magnet is attached to a push-button slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state.
It is another object of the present invention to provide the device as defined above, wherein at least start of sliding of said push-button is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
It is another object of the present invention to provide the device as defined above, wherein said activation controller controls start of energizing said electromagnet.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises at least one magnet. It is another object of the present invention to provide the device as defined above, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises at least two said magnets.
It is another object of the present invention to provide the device as defined above, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
It is another object of the present invention to provide the device as defined above, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the device as defined above, additionally comprising a dose counter.
It is another object of the present invention to provide the device as defined above, additionally comprising at least one sensor.
It is another object of the present invention to provide the device as defined above, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising: a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
It is another object of the present invention to provide the device as defined above, wherein said device additionally comprises a predefined volume configured to contain a least one fiowable substance.
It is another object of the present invention to provide the device as defined above, wherein said gas entrains said at least one fiowable substance such that said at least one fiowable substance has a predetermined distribution within said carrier gas.
It is another object of the present invention to provide the device as defined above, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
It is another object of the present invention to provide the device as defined above, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one fiowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein at least one said substance comprises a medicament.
It is another object of the present invention to provide the device as defined above, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
It is another object of the present invention to provide the device as defined above, further comprising a filter, said filter upstream of said at least one fiowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the device as defined above, wherein at least one said flowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the device as defined above, wherein said at least one flowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (Ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said predefined volume comprises a substance capsule removably containable said device.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true: a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance;
c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances;
i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule; m. at least one said compartment is at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane; o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
It is another object of the present invention to provide the device as defined above, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said polygon has between three sides and 20 sides.
It is another object of the present invention to provide the device as defined above, wherein said polygon is either a regular polygon or an irregular polygon.
It is another object of the present invention to provide the device as defined above, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance capsule, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule contains a single dose of said at least one flowable substance.
It is another object of the present invention to provide the device as defined above, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
It is another object of the present invention to provide a method for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of: a. providing a device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: i. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and iii. a controller in communication with said activation mechanism b. activating said device, said activation opening said gas capsule; and c. dispensing said gas through said distal end wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said controller with a communication mechanism.
It is another object of the present invention to provide the method as defined above, additionally comprising step of receiving, via said communication mechanism, a command selected from a group consisting of: a command to prevent said transition from said closed state to said open state, a command to allow said transition from said closed state to said open state, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a database.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing in said database a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of, during dispensing of said predetermined amount of gas under said predetermined pressure, releasing said gas from said gas capsule within a predetermined time, T. It is another object of the present invention to provide the method as defined above, additionally comprising step of dispensing said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT.
It is another object of the present invention to provide the method as defined above, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
c. said pressure rate,— -s co; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, <>·'/ o; and g. dT is in a range of about 0 to 500 millisecond; and h. any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing at least one activation controller and activating said activation mechanism via said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said activation controller either in physical communication with said device or in wireless communication with said device.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said activation controller in physical communication with said device from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said controller in wireless communication with said device as a remote control. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said device with two said bendable levers.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of bending of at least one said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said pushbutton with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet. It is another object of the present invention to provide the method as defined above, additionally comprising step of energizing said electromagnet by means of an activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least one magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said at least one magnet from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least two said magnets.
It is another object of the present invention to provide the method as defined above, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a dose counter.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least one sensor. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of: providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
It is another object of the present invention to provide the method as defined above, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
It is another object of the present invention to provide the method as defined above, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising at least one said flowable substance of a medicament.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti- autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of removably containing a substance capsule within said predefined volume.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps: a. selecting the number n of said compartments to be an integer in a range from 1 to 10;
b. providing at least one said compartment containing at least one said flowable substance;
c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume;
f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance;
j . for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule;
m. disposing at least one said compartment at the centroid of said substance capsule; n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
It is another object of the present invention to provide the method as defined above, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon with between three sides and 20 sides.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting at least one of the shape and size of the cross- section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different. It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
It is another object of the present invention to provide the method as defined above, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
It is another object of the present invention to provide a method for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of: a. providing a device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: i. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and iii. a database b. activating said device, said activation opening said gas capsule; and c. dispensing said gas through said distal end wherein said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a controller in communication with said activation mechanism.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said controller with at least two states, an operative state and an inoperative state, said controller, in said inoperative state, preventing said transition from said closed state to said open state and, in said operative state, allowing said transition from said closed state to said open state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of, during dispensing of said predetermined amount of gas under said predetermined pressure, releasing said gas from said gas capsule within a predetermined time, T.
It is another object of the present invention to provide the method as defined above, additionally comprising step of dispensing said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT.
It is another object of the present invention to provide the method as defined above, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
c. said pressure rate, ^ -s co; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, <>'/ ~→ o; and g. dT is in a range of about 0 to 500 millisecond; and
any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing at least one activation controller and activating said activation mechanism via said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said activation controller either in physical communication with said device or in wireless communication with said device.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said activation controller in physical communication with said device from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said controller in wireless communication with said device as a remote control.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube. It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said device with two said bendable levers.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of bending of at least one said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis. It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said pushbutton with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of energizing said electromagnet by means of an activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least one magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said at least one magnet from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least two said magnets. It is another object of the present invention to provide the method as defined above, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a dose counter.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least one sensor.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of: providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
It is another object of the present invention to provide the method as defined above, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
It is another object of the present invention to provide the method as defined above, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising at least one said flowable substance of a medicament.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti- autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of removably containing a substance capsule within said predefined volume.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps: a. selecting the number n of said compartments to be an integer in a range from 1 to 10;
b. providing at least one said compartment containing at least one said flowable substance;
c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume;
f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance;
j . for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule;
m. disposing at least one said compartment at the centroid of said substance capsule; n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
It is another object of the present invention to provide the method as defined above, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon with between three sides and 20 sides.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting at least one of the shape and size of the cross- section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
It is another object of the present invention to provide the method as defined above, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
It is another object of the present invention to provide a device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: a. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; wherein, during dispensing of said predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T; further wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT; further wherein at least one of the following is held true:
(a) P is in a range of about 2 - 10 barg;
(b) V is in a range of about 1 - 21 ml;
dp
(c) said pressure rate, dT ;
(d) said pressure rate dP/dT is greater than about 0.0001 barg /ms;
(e) said volume rate dV/dT is greater than about 0.001 ml /ms;
(f) said predetermined period of time, </r→ o; and
(g) dT is in a range of about 0 to 500 millisecond;
(h) and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising at least one activation controller configured to activate said activation mechanism.
It is another object of the present invention to provide the device as defined above, wherein said activation controller is either in physical communication with said device or in wireless communication with said device.
It is another object of the present invention to provide the device as defined above, wherein said activation controller in physical communication with said device is selected from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation controller in wireless communication with said device is a remote control. It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the device as defined above, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state. It is another object of the present invention to provide the device as defined above, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein at least start of movement of said piston relative to said fixed tube is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
It is another object of the present invention to provide the device as defined above, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
It is another object of the present invention to provide the device as defined above, wherein said device comprises two said bendable levers.
It is another object of the present invention to provide the device as defined above, wherein at least start of bending of at least one said lever is controllable by said activation controller. It is another object of the present invention to provide the device as defined above, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis. It is another object of the present invention to provide the device as defined above, wherein at least start of pivoting of said lever is controllable by said activation controller.
It is another object of the present invention to provide the device as defined above, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
It is another object of the present invention to provide the device as defined above, wherein said at least one second magnet is attached to a push-button slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state.
It is another object of the present invention to provide the device as defined above, wherein at least start of sliding of said push-button is controllable by said activation controller. It is another object of the present invention to provide the device as defined above, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
It is another object of the present invention to provide the device as defined above, wherein said activation controller controls start of energizing said electromagnet.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises at least one magnet.
It is another object of the present invention to provide the device as defined above, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises at least two said magnets.
It is another object of the present invention to provide the device as defined above, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
It is another object of the present invention to provide the device as defined above, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the device as defined above, additionally comprising a dose counter.
It is another object of the present invention to provide the device as defined above, additionally comprising at least one sensor.
It is another object of the present invention to provide the device as defined above, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
It is another object of the present invention to provide the device as defined above, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising:
a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT,
It is another object of the present invention to provide the device as defined above, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
It is another object of the present invention to provide the device as defined above, wherein said gas entrains said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
It is another object of the present invention to provide the device as defined above, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
It is another object of the present invention to provide the device as defined above, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein at least one said substance comprises a medicament.
It is another object of the present invention to provide the device as defined above, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof. It is another object of the present invention to provide the device as defined above, further comprising a filter, said filter upstream of said at least one fiowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the device as defined above, wherein at least one said fiowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the device as defined above, wherein said at least one fiowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said at least one fiowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N2O), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said predefined volume comprises a substance capsule removably containable said device. It is another object of the present invention to provide the device as defined above, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true:
a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance; c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances;
i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j . for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule;
m. at least one said compartment is at the centroid of said substance capsule; n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane;
o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
It is another object of the present invention to provide the device as defined above, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein said polygon has between three sides and 20 sides.
It is another object of the present invention to provide the device as defined above, wherein said polygon is either a regular polygon or an irregular polygon.
It is another object of the present invention to provide the device as defined above, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance capsule, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the device as defined above, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
It is another object of the present invention to provide the device as defined above, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof. It is another object of the present invention to provide the device as defined above, wherein said substance capsule contains a single dose of said at least one flowable substance.
It is another object of the present invention to provide the device as defined above, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
It is another object of the present invention to provide a smart device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end;
said device comprising: a. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; wherein during dispensing of said at least one predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T; further wherein said activation mechanism is in wireless communication with a remote controller, such that reconfiguration from said closed state to said open state can be enabled remotely.
It is another object of the present invention to provide the smart device as defined above, wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; and (b) volume rate ofdV /dT.
It is another object of the present invention to provide the smart device as defined above, wherein at least one of the following is held true:
a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
dP
c. said pressure rate, α'ϊ ; d. said pressure rate dP/dT is greater than about 0.000 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, dT■■■> 0; and g. dT is in a range of about 0 to 500 millisecond; h. and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the smart device as defined above, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state.
It is another object of the present invention to provide the smart device as defined above, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said remote controller.
It is another object of the present invention to provide the smart device as defined above, wherein at least start of movement of said piston relative to said fixed tube is controllable by said remote controller.
It is another object of the present invention to provide the smart device as defined above, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
It is another object of the present invention to provide the smart device as defined above, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
It is another object of the present invention to provide the smart device as defined above, wherein said device comprises two said bendable levers.
It is another object of the present invention to provide the smart device as defined above, wherein at least start of bending of at least one said lever is controllable by said remote controller.
It is another object of the present invention to provide the smart device as defined above, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis. It is another object of the present invention to provide the smart device as defined above, wherein at least start of pivoting of said lever is controllable by said remote controller. It is another object of the present invention to provide the smart device as defined above, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
It is another object of the present invention to provide the smart device as defined above, wherein said at least one second magnet is attached to a push-button slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state. It is another object of the present invention to provide the smart device as defined above, wherein at least start of sliding of said push-button is controllable by said remote controller. It is another object of the present invention to provide the smart device as defined above, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
It is another object of the present invention to provide the smart device as defined above, wherein said remote controller controls start of energizing said electromagnet.
It is another object of the present invention to provide the smart device as defined above, wherein said activation mechanism comprises at least one magnet.
It is another object of the present invention to provide the smart device as defined above, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said activation mechanism comprises at least two said magnets.
It is another object of the present invention to provide the smart device as defined above, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
It is another object of the present invention to provide the smart device as defined above, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the smart device as defined above, wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the smart device as defined above, additionally comprising a dose counter.
It is another object of the present invention to provide the smart device as defined above, additionally comprising at least one sensor.
It is another object of the present invention to provide the smart device as defined above, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising:
a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT, It is another object of the present invention to provide the smart device as defined above, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
It is another object of the present invention to provide the smart device as defined above, wherein said gas entrains said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas. It is another object of the present invention to provide the smart device as defined above, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
It is another object of the present invention to provide the smart device as defined above, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein at least one said substance comprises a medicament.
It is another object of the present invention to provide the smart device as defined above, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, further comprising a filter, said filter upstream of said at least one flowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the smart device as defined above, wherein at least one said flowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the smart device as defined above, wherein said at least one flowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof. It is another object of the present invention to provide the smart device as defined above, wherein said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B 12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis,
6l steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said predefined volume comprises a substance capsule removably containable said device.
It is another object of the present invention to provide the smart device as defined above, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true: a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance;
c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances; i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule;
m. at least one said compartment is at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane;
o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
It is another object of the present invention to provide the smart device as defined above, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said polygon has between three sides and 20 sides.
It is another object of the present invention to provide the smart device as defined above, wherein said polygon is either a regular polygon or an irregular polygon.
It is another object of the present invention to provide the smart device as defined above, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance device, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof. It is another object of the present invention to provide the smart device as defined above, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
It is another object of the present invention to provide the smart device as defined above, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
It is another object of the present invention to provide the smart device as defined above, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof.
It is another object of the present invention to provide the smart device as defined above, wherein said substance capsule contains a single dose of said at least one flowable substance. It is another object of the present invention to provide the smart device as defined above, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
It is another object of the present invention to provide a method for delivering for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of:
a. providing a device for delivering said at least one predetermined amount, V, of said gas under said predetermined pressure P, to said natural orifice of said body, said device characterized by a main longitudinal axis, a proximal end and a distal end;
said device comprising:
i. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; and
ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state;
b. activating said delivery device, said activation opening said gas capsule; and c. dispensing said gas through said distal end
thereby releasing said gas from said gas capsule in a predetermined time, T, and delivering said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT; wherein at least one of the following is held true:
(a) P is in a range of about 2 - 10 barg;
(b) V is in a range of about 1 - 21 ml;
(c) said pressure rate, dr ;
(d) said pressure rate dP/dT is greater than about 0.0001 barg /ms;
(e) said volume rate dV/dT is greater than about 0.001 ml /ms;
(f) said predetermined period of time, <<'>' ™> 0; and
(g) dT is in a range of about 0 to 500 millisecond;
and any combination thereof,
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing at least one activation controller and activating said activation mechanism via said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said activation controller either in physical communication with said device or in wireless communication with said device.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said activation controller in physical communication with said device from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said controller in wireless communication with said device as a remote control.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state. It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever. It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said device with two said bendable levers.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of bending of at least one said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said pushbutton with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet. It is another object of the present invention to provide the method as defined above, additionally comprising step of energizing said electromagnet by means of an activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least one magnet. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said at least one magnet from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least two said magnets.
It is another object of the present invention to provide the method as defined above, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a dose counter.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least one sensor.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof. It is another object of the present invention to provide the method as defined above, additionally comprising steps of: providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT,
It is another object of the present invention to provide the method as defined above, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
It is another object of the present invention to provide the method as defined above, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising at least one said flowable substance of a medicament.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti- autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of removably containing a substance capsule within said predefined volume.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps:
a. selecting the number n of said compartments to be an integer in a range from 1 to 10;
b. providing at least one said compartment containing at least one said flowable substance;
c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume; f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area; h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances; i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance; j. for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule;
m. disposing at least one said compartment at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
It is another object of the present invention to provide the method as defined above, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof. It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon with between three sides and 20 sides. It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting at least one of the shape and size of the cross- section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances. It is another object of the present invention to provide the method as defined above, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
It is another object of the present invention to provide a method for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of:
a. providing a smart device for delivering said at least one predetermined amount, V, of said gas under said predetermined pressure P, to said natural orifice of said body, said device characterized by a main longitudinal axis, a proximal end and a distal end;
said device comprising:
i. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure;
ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and
iii. a remote controller in wireless communication with said activation mechanism; and
b. activating said remote controller;
thereby remotely controlling reconfiguring said activation mechanism from said closed state to said open state, releasing said gas from said gas capsule within a predetermined time, T, and dispensing said predetermined amount of gas under said predetermined pressure. It is another object of the present invention to provide the method as defined above, additionally comprising step of delivering said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; and (b) volume rate ofdV /dT.
It is another object of the present invention to provide the method as defined above, additionally comprising at least one of the following steps:
a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml; c. dT ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, « ~-> 0; and g. dT is in a range of about 0 to 500 millisecond; and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever. It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said device with two said bendable levers.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of bending of said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet. It is another object of the present invention to provide the method as defined above, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said pushbutton with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet. It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling start of energizing said electromagnet by means of said remote controller.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least one magnet. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said at least one magnets from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of at least two said magnets.
It is another object of the present invention to provide the method as defined above, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing a dose counter.
It is another object of the present invention to provide the method as defined above, additionally comprising step of providing at least one sensor.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof. It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT,
It is another object of the present invention to provide the method as defined above, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
It is another object of the present invention to provide the method as defined above, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of comprising at least one said flowable substance of a medicament.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency,
8l medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1- alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti- autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of removably containing a substance capsule within said predefined volume.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps:
a. selecting the number n of said compartments to be an integer in a range from 1 to 10; b. providing at least one said compartment containing at least one said flowable substance; c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes; e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume;
f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance;
j. for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule; m. disposing at least one said compartment at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
It is another object of the present invention to provide the method as defined above, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof. It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof. It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon with between three sides and 20 sides. It is another object of the present invention to provide the method as defined above, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting at least one of the shape and size of the cross- section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances. It is another object of the present invention to provide the method as defined above, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
It is another object of the present invention to provide the method as defined above, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
BRIEF DESCRIPTION OF THE FIGURES
In order to better understand the invention and its implementation in practice, a plurality of embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, wherein
Figs. 1A-C schematically illustrate devices of prior art;
Fig. 2 schematically illustrates locations for deposition of substances entering the nostrils;
Fig. 3 schematically illustrates an exemplary embodiment of a delivery device;
Figs. 4-8 schematically illustrate embodiments of the medicine compartment of the present invention; and
Figs. 9-22 schematically illustrate embodiments of devices comprising the capsule of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIEMNTS
The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a means and method for providing a capsule to enable storage and delivery of at least one flowable substance. The capsule, in conjunction with a delivery device, is adapted to deliver the flowable substances to a desired location in the body; e.g., to the nasal cavities, but also to the mouth, throat or lungs.
One of the main objects of the present invention is to provide a capsule for storing flowable substances such that the flowable substances can remain separate until the time of use, but can be properly mixed at the time of use. The capsule can be used in conjunction with any delivery device adapted to provide sufficient gas under sufficient pressure to enable proper mixing of the flowable substances with each other and with the gas.
In preferred embodiments, the propellant gas is air; the substance is mixed with a volume of air in the range of about 5 - 50 ml and compressed before delivery to a pressure of about 1.5 to 10 bar.
In embodiments of the delivery system, compressed air carries/entrains flowable substance to the nasal passages. Thus, in preferred embodiments, the energy stored in compressed air or gas is used as a carrier to deliver medicament to the nasal cavity. In these embodiments, the volume of air being compressed is in the range of the nasal cavity volume. Said volume serves as a carrier of a medicament for better dispersion and more targeted deposition in the nasal cavity.
In embodiments of the delivery system, the pressure to which the gas/air (i.e., the carrier entraining the substance) is compressed and the volume of said gas/sir can be fined tuned and tailored to fit the delivery destination (e.g., respiratory epithelium, olfactory epithelium, brain, lungs, pharynx, heart and any combination thereof).
It should be pointed out that the substance or substances (e.g., the medicament or medicaments) is preferably delivered to nasal passages so as to be delivered to at least one selected from a group consisting of respiratory epithelium, olfactory epithelium, brain, lungs, pharynx, heart and any combination thereof through the nasal passages. Delivery of the substance through the nasal cavity enables it to be delivered to at least one selected from a group consisting of respiratory epithelium, olfactory epithelium, brain, lungs, pharynx, heart and any combination thereof through the nasal passages. Substances can be delivered to the middle and upper turbinates, from whence they can cross, via the thin ethmoid bone, into the brain, thus bypassing the blood/brain barrier and efficiently delivering substances, especially medicaments, to the brain.
The term 'flowable substance' hereinafter refers to any substance capable of flowing; such a substance can be a granular material, including a gas; a powder; a liquid; a gel; a slurry; a suspension; an aerosol; and any combination thereof.
The term 'capsule' hereinafter refers to a container adapted to contain a flowable substance. The term will also be referred hereinafter as 'flowable substance capsule'. The flowable substance need not be a medicament.
The term 'plurality' hereinafter refers to an integer greater than or equal to two.
The term 'olfactory epithelium' hereinafter refers to a specialized epithelial tissue inside the nasal cavity. The olfactory epithelium lies on the upper top portion of the nasal cavity behind the nostrils.
The term 'gas' refers to any fluid that can be readily compressed. Gases as used herein include, but are not limited to, air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon. Devices charged by hand will normally use air as the carrier gas. Preferred gases for use with compressed-gas charging are air, nitrogen and carbon dioxide.
The term 'channel' hereinafter refers to a passageway allowing passage of a fluid through at least a portion of a mixing mechanism. The channel can be disposed within a portion of the mixing mechanism, forming a closed bore; it can be on an exterior of a portion of the mixing mechanism, forming a groove on the portion of the mixing mechanism, and any combination thereof.
The term 'about' refers hereinafter to a range of 25% below or above the referred value. In Figs. 4 - 10, like numbers indicate like parts.
The capsule of the present invention can apply a broad range of drugs and materials to the nasal cavity for local effect, deliver a broad range of drugs and materials through the nasal cavity to the systemic circulation, deliver a broad range of drugs and materials through the nasal cavity to the central nerve system (CNS) the brain, spinal cord and associated nerves, and any combination thereof. The drugs to be applied could be, but are not limited to, pharmaceuticals, natural compounds, biologies, hormones, peptides, proteins, viruses, cells, stem cells and any combination thereof.
In preferred embodiments of the delivery device, compressed air is used to entrain the flowable substance, enabling delivery the substance to the olfactory epithelium and from there to the brain. Since the preferred carrier is air, the application can be in powder form, in liquid form or in any other formulation known in the art. The substance can be stored in its most convenient form, either as a liquid, an aerosol, a powder, a slurry, a suspension, or a gel, if thin enough. The substance can be stored either with or without a carrier; the carrier can be a liquid, a gas or a powder. Preferably, the substance is stored without carrier; however, in some embodiments, the substance is stored in a carrier. If stored with a carrier, the carrier can be a gas, a liquid or a particulate powder.
The substance as delivered can comprise a powder, a mixture of liquid and powder, a mixture of gas and powder, a mixture of powders, a liquid, a mixture of liquid and gas, a mixture of liquids, a gas, or a mixture of gases.
In embodiments where the substance is stored without carrier, the volume and weight of the substance will be small, enabling easier and more convenient storage and easier and more convenient use. When medicaments are stored in a liquid carrier, such as those used in metered dose inhalers, the formulation as stored is on the order of 99% carrier; a given number of doses of a medicament in a formulation without carrier occupies only about 1% of the volume that the same number of doses of the same medicament occupies if the formulation includes a carrier, such as a formulation intended for use in a metered dose inhaler canister.
The substance can be packaged to minimize degradation, for example, by packaging it in vacuum or under an inert atmosphere. In most embodiments, storage capsule containing the will be a single-use so that a single, controllable dose can be delivered with each use of the device.
Use of an inert gas for the carrier for delivery of the medication obviates the possibility of interactions between the user and the delivery carrier; allergies to carriers, especially in medications used for chronic illnesses, is a growing problem. Furthermore, the delivery carrier is in contact with the medicament for no more than a few seconds and more commonly for no more than a few milliseconds, thereby minimizing degradation of the medicament due to interactions with the delivery carrier.
In most embodiments, the substance will be a medicament.
Examples of types of drugs and materials to be delivered to or through the nose are, but not limited to: treatments for allergic rhinitis; treatments for osteoporosis; vaccinations and immunizations; sexual dysfunction drugs; treatments for B12 deficiency; smoking cessation; treatment of gynecological problems; treatment of other women's health issues; general anesthetics; local anesthetics; opioid analgesics; agonist-antagonists and antagonists; antitussives; drugs used in the treatment of motor disorders; antiepileptics; drugs used in affective disorders; antipsychotics (neuroleptics); sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants; treatments for anxiety disorders; skeletal muscle relaxants; treatments for Parkinson's disease; treatments for Alzheimer's disease;
Medicaments for treatment of allergic rhinitis include, but are not limited to: steroids, including corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort and Veramyst.
Medicaments for treatment of osteoporosis include, but are not limited to, Miacalcin, Fortical and Stadol.
Medicaments for vaccinations and immunizations include, but are not limited to: LAVIN, and influenza vaccines including FluMist.
Medicaments for smoking cessation include, but are not limited to: NasalFent.
Other medicaments which can be delivered include, but are not limited to, calcitonin and parathyroid hormone.
Neurotransmitters and neuromodulators that can be delivered include, but are not limited to: acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, and Substance P.
General anesthetics which can be delivered include, but are not limited to: alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N2O), propofol, sevoflurane, Sufentanil, Sublimase, and thiopental.
Local anesthetics which can be delivered include, but are not limited to: benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, and tetracaine.
Opioid analgesics, agonist-antagonists, and antitussives which can be delivered include, but are not limited to: agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol.
Cannabis cannabinoids, and cannabis derivatives can also be delivered.
Agonist/antagonists and antagonists which can be delivered include, but are not limited to: buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone.
Drugs used in the treatment of Parkinson's disease and motor disorders which can be delivered include, but are not limited to: amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, and COMT inhibitor.
Antiepileptics which can be delivered include, but are not limited to: acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin and Midazolam.
Drugs used in affective disorders which can be delivered include, but are not limited to: antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate and valproic acid.
Antipsychotics (neuroleptics) which can be delivered include, but are not limited to: chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene and ziprasidone. Sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants which can be delivered include, but are not limited to: alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon and Zolpidem.
Anxiety disorders and skeletal muscle relaxants which can be delivered include, but are not limited to: alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, and oxazepam.
Other drugs which can be delivered include, but are not limited to: amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, anti ADHD drugs such as Methylphenidrate (ritalin), and anti-autism and anti -autism symptoms drugs.
Treatment of Alzheimer's disease which can be delivered include, but are not limited to: donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulinlike hormone, dopamine agonist and dopamine antagonist.
Figs. 1A-C illustrate capsules of prior art intended to deliver medicaments to the nasal passages. Figs 1A and 1C comprise frangible capsules containing a single medicament. In use, the use breaks the capsule by pressure on a mechanism comprising part of the delivery device, and mixing of the contents of the capsule and air occurs when the patient inhales. Fig. IB comprises a vial; the top of the vial is broken to deliver the medication.
In these typical prior art devices, if more than one substance is to be delivered, the substances will mix in the capsule or vial during storage and prior to delivery. Reactions can occur between the various components, limiting storage time and possibly requiring inconvenient storage conditions, such as keeping the capsules in a refrigerator before use.
The pressure to deliver the substance is the pressure of inhalation, which is quite variable, both between patients and between different inhalations by the same patient.
Fig. 2 illustrates locations for deposition of substances entering the nostrils. Typical locations are deposition in the lungs after passage through the lower turbinates (240), thereby enabling transfer of the substance across the walls of the alveoli of the lungs; deposition in the mucous membranes lining the nasal passages, especially the lower (240), middle (230) and upper (220) turbinates, facilitating transfer of the substance to the blood; and deposition in the olfactory mucous membranes of the upper turbinates (220) facilitating transfer, via the thin ethmoid bone (not shown) to the brain.
In the capsule of the present invention, the device comprises at least one compartment, and preferably a plurality of compartments, each containing a flowable substance. The delivery device is designed to rupture the compartments such that the flowable substances are mixed with a carrier, preferably air, and delivered to a predetermined deposition site, typically, but not exclusively, in the nasal passages.
Medicaments may be supplied as liquids, as powders, or as aerosols. In the preferred embodiment, the medicament is supplied in a single-dose capsule. In other embodiments, the medicament is supplied in a multi-dose capsule means, the multi-dose capsule adapted to provide a single dose per activation.
In preferred embodiments, the flowable-substance capsule has a plurality of compartments. A compartment can contain at least one medicament, at least one medicament precursor, carrier gas, compressed gas, and any combination thereof.
The different compartments can contain different medicaments, with the plurality of medicaments delivered to the nostril or other delivery site in a single dose. In this manner, a plurality of medicaments may be supplied to the nostril in a single injection, with interactions occurring between the medicaments at most during the short time between rupturing of the capsule and delivery of the substances to the deposition site.
According to another embodiment, the capsule can enable combining medicament with formulation solely during the activation procedure, thus eliminating interactions between the medicaments and the formulations prior to activation and release to the nasal cavity.
In some embodiments, the capsule is designed such that at least two substances will react after rupture of the capsule and prior to deposition. In such embodiments, unstable substances can be reliably delivered to a deposition site. In some variants of such embodiments, rupture of the capsule during the delivery phase enables mixing of the substances and their reaction. In such embodiments, the reaction must be such as to occur in at most a few seconds, between the time the capsule is ruptured and the reacted material deposits at the desired site in the body. In other variants, the delivery process involves at least one step during which at least one separator between at least two compartments in the capsule is ruptured. Rupture of this separator enables the contents of the at least two compartments to mix and react. It is clear that there can be a sequence of reactions, with, for non-limiting example, precursor A mixing with precursor B to form intermediate C, and, subsequently, intermediate C mixing with precursor D to form final product E.
An exemplary and non-limiting embodiment of part of a delivery device is illustrated in Fig. 3. In this embodiment, the nosepiece (6), the capsule (21) and the mouthpiece (5) are removable, and the handle (4) pivots about the lower end of the proximal end (3). In this embodiment, the piston driver (13) does not comprise a hinge, enabling it to be manufactured as a single piece.
In Fig. 3, the handle (4) is illustrated in the open position (i.e., the extended position).
In some embodiments, the capsule comprises a nosepiece (6) and at least one medicine compartment (21) as a single unit, which is removable and replaceable. In some embodiments, this is a single-use unit, where the medicine compartment (21) is not refillable, the unit being discarded after use. In other embodiments, the device (21) comprises a cartridge of medicine capsules, with means to replace an exhausted capsule with an unused one. In some variants of this embodiment, the cartridge can be replaced. In other variants, the cartridge is single-use, the nosepiece unit (43) being discarded when the cartridge is exhausted. In yet other embodiments, the nosepiece (43 or 6) and capsule (21) form two units, enabling replacement of either the nosepiece (6, or 43) or capsule (21), as appropriate.
The capsule can be single-use, comprising at least one of a substance, a carrier, a compressed gas, a propellant, and any combination thereof. Similarly, a multi-dose cartridge can comprise multiple capsules, each capsule comprising at least one of a substance, a carrier, a compressed gas, a propellant, and any combination thereof.
The capsule can be single -compartment or can comprise at least two compartments. In some embodiments, at least one compartment contains a propellant such as compressed air (air compartment). In such embodiments, charging is enabled by causing the compressed air to flow from the at least one compressed air compartment into a compressed air chamber in the device, said compressed air chamber fluidly connected to air channel 16. An illustrative example of a method of causing the compressed air to flow from the at least one compressed air compartment into the compressed air chamber in the device comprises a port on the enclosure such that, when the flowable substance chamber is mounted to the enclosure, the port is enabled to fluidly connect the at least one compressed air compartment to the compressed air chamber. Retracting the handle (4) or placement of the capsule in its capsule retainer position (44) causes a piercing means to pierce a wall of the at least one compartment of the capsule, causing the air to flow from the at least one compressed air compartment into the at least one flowable substance chamber of the capsule. Many other methods of causing the compressed air to flow from the at least one compressed air compartment through the other compartments and to a deposition site will be obvious to persons with ordinary skill in the art.
Figs. 4-8 show embodiments of capsules adapted to contain a plurality of flowable substances.
As described above, the contents of the at least one compartment comprise a flowable substance in the form of a liquid, a particulate, a powder, an aerosol, a slurry, a gel, a suspension, a gas and any combination thereof. The flowable substance can comprise a medicament or medicament precursor, a propellant, or any combination thereof. Typically, the propellant is a compressed gas, such as oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
In the exemplary embodiment schematically illustrated in Fig. 4, the capsule (100) comprises three compartments (130), sequentially disposed along the main longitudinal axis of the capsule, so that the compartments are placed "one after the other". The compartments are preferably hermetically sealed, being separated by frangible walls (not shown).
In some embodiments, at least one of the compartments contains compressed gas. The gas can be comprised of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
In sequentially-disposed compartments, the order of mixing or reaction of the flowable substances is fixed, determined by the order in which the substances are arranged. In use, pressure applied to the upstream end of the capsule will rupture the upstream closure surface. This will compress the flowable substance within the upstream compartment (substance 1); the pressure will then rupture the membrane closing the downstream end of the upstream compartment, allowing mixing and/or reaction between substance 1 and the contents of the next compartment (substance 2). This process then sequentially repeats until all the membranes have ruptured. If desired, a mixing mechanism, as described below, can be provided to provide a final mixing and/or reaction region.
Substances which require a minimum of exposure to air can be position in the compartment that is furthest downstream and stored in an inert atmosphere, thereby minimizing exposure of such substances to the air.
Typically, the number of compartments is between 1 and 10.
In the embodiment shown, up to three different flowable substances can be stored; however, more than one compartment can contain the same flowable substance.
In the embodiment shown, the compartments are of substantially equal size. In other embodiments, different compartments can be of different sizes.
The frangible walls separating the compartments and the frangible walls closing the capsule can have substantially the same breaking strengths, different frangible walls can have substantially different breaking strengths, different regions in a frangible wall can have different breaking strengths, and any combination thereof.
In the embodiment shown in Fig.5, the compartments (130) are coaxially disposed within the outer tegument (110), with the compartments nested within one another, with the central compartment forming a cylinder and the remaining compartments, three in the exemplary embodiment shown in Fig. 5, each forming an annulus of a cylinder.
In the exemplary embodiment shown in Fig. 5, the compartments have approximately the same thickness. In other variants, the compartments have different thicknesses. In some embodiments, the thicknesses are such that the compartments have substantially the same volume.
In the exemplary embodiment shown, the compartment walls have substantially circular cross-section, as does the tegument of the capsule. In some embodiments, as in this one, the compartment walls are substantially similar in cross-sectional shape to the capsule walls (for non-limiting example, lenticular walls within a lenticular capsule). In other embodiments, at least one of the compartments' walls' cross section differs in shape from the shape of the cross-section of the capsule. (For non-limiting example, a lenticular wall within a circular capsule.) At least one wall separating compartments can be frangible, so that the contents of the at least two compartments mix or react before leaving the compartments, at least one compartment can have a frangible membrane at at least one end, and any combination thereof.
In the embodiment schematically illustrated in Fig. 6, the capsule (100) comprises an outer tegument (110) enclosing, in the embodiment shown in Fig. 6, n angularly disposed compartments (130) separated by walls (120). In this embodiment, n is six.
The walls (120) divide the capsule (100) into the different compartments (130); before use, the compartments are preferably hermetically sealed so that there is no mixing of the up to (in this embodiment) six different flowable substances contained therein. It is clear that two or more of the compartments can contain the same flowable substance.
In the embodiment shown in Fig. 6, the compartments (130) are of similar size. In other variants of this embodiment, the compartments have different sizes.
In the embodiment shown in Fig. 6, the compartments (130) are substantially equally spaced. In other variants of this embodiment, spacings between the compartments differ. Spacings can be arbitrary, they can be regular, they can follow a pattern, and any combination thereof.
The capsule can have any number of compartments; in practice, there will be no more than 10 compartments.
In the embodiment schematically illustrated in Fig. 7, the capsule (100) comprises an outer tegument (110) enclosing, in the embodiment shown in Fig. 7, six angularly disposed cylindrical compartments near the edge of the capsule (130) a central compartment (140), and auxiliary compartments (150, 155), thereby enabling storage of, in the exemplary embodiment shown in Fig. 7, up to 14 different flowable substances. It is clear that any pair of compartments can contain either the same substance (or mixture thereof) or different substances (or mixtures thereof).
The compartments are preferably hermetically sealed so that there is no mixing of the flowable substances contained therein before use. In the exemplary embodiment shown in Fig. 7, the angularly disposed compartments (130) and the central compartment (140) are of similar size and have small volumes relative to the remainder of the capsule (150, 155).
In some variants of this embodiment, at least some of the angularly disposed compartments (130) and the central compartment (140) are of different sizes. In some variants, the compartments, taken together, form a large fraction of the volume of the capsule.
In the embodiment shown in Fig. 7, the compartments (130, 140) are of similar size. In other variants of this embodiment, the compartments have different sizes.
In the embodiment shown in Fig. 7, the compartments (130) are substantially equally spaced. In other variants of this embodiment, spacings between the compartments differ. Spacings can be arbitrary or they can be regular, they can follow a pattern, and any combination thereof.
The capsule can have any number of compartments; in practice, there will be no more than 20 compartments.
In some embodiments, there is no central compartment (140).
In the exemplary embodiment shown, the auxiliary compartments are hollow, containing a flowable substance. In other embodiments, at least one of the auxiliary compartments (150, 155) is comprised of solid material, thereby forming part of the structure of the capsule.
In a preferred embodiment, the central compartment (140) and the central auxiliary compartment (155) are solid, forming a solid central core for the structure. The remaining compartments (130, 150) comprise flowable substance, where, in preferred embodiments, the compartments (130) contain a flowable substance such as a medicament and the auxiliary compartments (150) contain apropellant, preferably compressed gas.
In the embodiment shown, the compartments (130, 150) are near the edge of the capsule; in other embodiments, they are at other positions within the capsule.
In the exemplary embodiment shown in Fig. 8, the compartments (130) form slices within the outer tegument (110). In the exemplary embodiment of Fig. 8, some of the slices have parallel sides, while the central slice is wedge-shaped; in other embodiments, all of slices have substantially parallel sides. In yet other embodiments, a plurality of slices are wedge- shaped. In this exemplary embodiment, the slices are of different widths; in some embodiments, at least some of the slices have substantially the same width.
Embodiments of slice-type capsules can have up to 10 compartments.
In the exemplary embodiment shown, the walls separating the compartments are planar. In other embodiments, the walls can form a curve, either regular or irregularly shaped. The main longitudinal axis of at least one of the compartments can be parallel to the main longitudinal axis of the capsule, it can be spirally disposed it can be at an angle to the main longitudinal axis of the capsule, and any combination thereof.
The main longitudinal axes of the compartments can be straight, they can form regular curve, they can form irregular curves, and any combination thereof. For any pair of compartments, the main longitudinal axes can be the same or they can be different.
In most embodiments, at least part of the upstream closure surface (not shown) and the downstream closure surface (not shown) of the capsule are frangible or otherwise removable, such that, when broken or otherwise removed, the medications can be delivered to the desired deposition site. In a variant of these embodiments, different portions at least one closure surface have different breaking strengths, such that the different portions can be broken at different times during delivery of the medication, enabling either differential mixing of medical formulations in different compartments or differential delivery of the medications in at least two of the compartments.
In some embodiments, at least part of the side surface of the capsule is frangible, enabling yet another mixing path or delivery path.
In some embodiments, the capsules are cylindrical with circular cross-section, as shown. In other embodiments, the capsules are cylindrical with oval, elliptical, lenticular, or polygonal cross-section, with the polygon having at least three sides and preferably not more than 20 sides. The polygon can be a regular polygon or an irregular polygon.
In other embodiments, the capsules can be spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof. Capsules can form regular shapes or irregular shapes.
In preferred embodiments, the compartments have substantially constant cross-section through the device. In other embodiments, the cross-section of the compartments varies in area, in shape, or in any combination thereof.
Criteria of the capsule can be optimized to include: ensuring that a single dose of the substance is delivered in its entirety, ensuring that the single dose contains the predetermined amount of the substance, ensuring that the dose is delivered to the desired region of the nose, and ensuring that delivery of the dose causes the minimum possible discomfort to the patient. Any combination of these criteria can be optimized for; each particular combination giving rise to a different embodiment of the capsule. The capsule can also be optimized for ease of insertion into a delivery device, for ease of removal from a delivery device, for stability of the contents during storage, for resistance of the capsule materials to environmental degradation, for resistance to undesired fracture, for reliability of use, for completeness of mixing, for completeness of reaction, and any combination thereof.
In some embodiments, the capsule comprises a filter adapted to remove from the air at least one selected from a group consisting of particles, particulates, bacteria, viruses, moisture, and undesired gases before the air contacts the user. Such a filter, by preventing unpleasant odors or tastes from reaching the user and by preventing particles or particulates from reaching the user, can make the experience of using the device much more pleasant for the user. By removing bacteria and viruses, infection of the user can be prevented.
In some embodiments, the capsule contains only a single dose of the substance, the capsule being replaced after each use. In other embodiments, the capsule contains multiple doses of the substance, preferably packed separately, so that the dose is fresh for each use.
It should be emphasized that any embodiment of the present invention and any variant thereof can be used for both for humans (medical use) and animals. Thus, any of the devices as disclosed above and any variant thereof can be used for veterinary applications as well as (human) medical applications.
The capsule of the present invention can contain and store a broad range of drugs and materials.
The drugs to be contained and stored can be, but are not limited to, pharmaceuticals, natural compounds, biologies, hormones, peptides, proteins, viruses, cells, stem cells and any combination thereof.
In most embodiments, the substance will be a medicament.
Examples of types of drugs and materials to be contained and stored can be, but not limited to: treatments for allergic rhinitis; treatments for osteoporosis; vaccinations and immunizations; sexual dysfunction drugs; treatments for B12 deficiency; smoking cessation; treatment of gynecological problems; treatment of other women's health issues; general anesthetics; local anesthetics; opioid analgesics; agonist-antagonists and antagonists; antitussives; drugs used in the treatment of motor disorders; antiepileptics; drugs used in affective disorders; antipsychotics (neuroleptics); sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants; treatments for anxiety disorders; skeletal muscle relaxants; treatments for Parkinson's disease; treatments for Alzheimer's disease;
Medicaments for treatment of allergic rhinitis include, but are not limited to: steroids, including corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort and Veramyst.
Medicaments for treatment of osteoporosis include, but are not limited to, Miacalcin, Fortical and Stadol.
Medicaments for vaccinations and immunizations include, but are not limited to: LAVIN, and influenza vaccines including FluMist.
Medicaments for smoking cessation include, but are not limited to: NasalFent.
Other medicaments which can be delivered include, but are not limited to, calcitonin and parathyroid hormone.
Neurotransmitters and neuromodulators that can be delivered include, but are not limited to: acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, and Substance P.
General anesthetics which can be delivered include, but are not limited to: alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, and thiopental.
Local anesthetics which can be delivered include, but are not limited to: benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, and tetracaine.
Opioid analgesics, agonist-antagonists, and antitussives which can be delivered include, but are not limited to: agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol. Agonist/antagonists and antagonists which can be delivered include, but are not limited to: buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone.
Drugs used in the treatment of Parkinson's disease and motor disorders which can be delivered include, but are not limited to: amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, and COMT inhibitor.
Antiepileptics which can be delivered include, but are not limited to: acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin and Midazolam.
Drugs used in affective disorders which can be delivered include, but are not limited to: antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate and valproic acid.
Antipsychotics (neuroleptics) which can be delivered include, but are not limited to: chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene and ziprasidone.
Sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants which can be delivered include, but are not limited to: alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon and Zolpidem.
Anxiety disorders and skeletal muscle relaxants which can be delivered include, but are not limited to: alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, and oxazepam.
Other drugs which can be delivered include, but are not limited to: amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, anti ADHD drugs such as Methylphenidrate (ritalin), and anti-autism and anti -autism symptoms drugs.
Treatment of Alzheimer's disease which can be delivered include, but are not limited to: donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulinlike hormone, dopamine agonist and dopamine antagonist.
In some embodiments, sequential compartments, as shown in Fig. 4, are combined with any of the longitudinal compartments, as shown in Figs. 5 to 8, thereby enabling more sophisticated control of the order in which flowable substances are mixed. In such embodiments, at least one frangible membrane divides the upstream and downstream ends of, for non-limiting example, a cylindrical compartment (Fig. 7). In such an embodiment, pressure on the cylindrical compartment ruptures the internal frangible membrane, mixing and/or reacting the flowable substances in the upstream and downstream sub-compartments. This is followed by the mixing and/or reaction of this material with the contents of the other compartments, which may similarly have undergone similar mixing and/or reactions.
It should be noted that, in any of the embodiments exemplified in Figs. 4-8, none or more of the compartments can contain pressurized gas, comprising air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
It should be further noted that, by controlling the size of the compartments, the driving pressure of the propellant and the pressure inside any compressed gas compartments, the time during which flowable substances can interact can be predetermined, thereby, for non- limiting example, controlling the completeness of reactions and the time during which materials are exposed to air.
As described above, in some embodiments, the system needs no pre-pressurization because at least one compartment of a capsule contains a pressurized gas. In a preferred variants of such embodiments, the compartment containing the pressurized gas forms a gas capsule fluidly connectable to the at least one compartment containing the substance; the at least one compartment containing the substance being the substance capsule. In such variants, the fluid connection is formed by creation of an opening in the gas capsule. In some embodiments comprising a separate gas capsule and substance capsule, an opening is formed in the substance capsule at a time substantially simultaneous with the opening of the gas capsule. In other embodiments comprising a separate gas capsule and substance capsule, the substance capsule is not sealed or is opened at a time substantially before the activation of the device and the opening of the gas capsule; in other embodiments comprising a separate gas capsule and substance capsule, the substance capsule is opened substantially after the gas capsule is opened.
The gas capsule can be opened by piercing of a membrane, by bursting of a membrane, by removing an airtight seal from a preformed opening, or by any other means known in the art. Removal of the seal can be by sliding a sealing mechanism to uncover the opening, by lifting a sealing mechanism, by rotating a sealing mechanism, by any combination thereof, or by any other means known in the art from removing a seal from an opening.
Device embodiments, comprising embodiments of activation mechanisms and embodiments of opening mechanisms, are disclosed below. It should be noted that the disclosed combinations of embodiments are not limiting; other combinations of activation mechanism and opening mechanism are possible and are within the scope of the invention.
In the embodiments disclosed below, for clarity, no substance capsule is shown. The distal portion of the device, comprising a substance chamber and a nozzle, is illustrative.
In some embodiments, the gas capsule is opened by means of a piercing mechanism. A device (1200) comprising a piercing mechanism is shown in Figs. 9-10. Fig. 9A-B shows external views of the device, Fig. 9C shows an exploded view and Fig. lOA-C shows section views along the line A-A of Fig. 9A. Fig. 9A shows the device from the side and Fig. 9B is a perspective view of the device from the bottom.
In Figs. 9-10, the device (1200) comprises a nozzle (1240) with a removable cap (1250) at its distal end. The body of the device comprises a distal portion (1230) and a proximal portion (1210). The distal portion (1230) is fixed to the nozzle (1240). The proximal portion (1210) is slidably connected to the distal portion (1230). In use, the removable cap (1250) would be removed before activation.
A flange (1232) on the body distal portion (1230) is configured for a user to place his fingers on it and the device is activated by the user pressing the body proximal portion (1210) inward so that it slides distally into the body distal portion (1230). Compressing the device in this manner forces the piercer (1120) into the gas capsule (not shown) and allows escape of the pressurized gas.
Fig. 10A shows a sectional side view of the device along the line A-A of Fig. 9A. Fig. 10B- C shows an enlarged sectional side view of the portion of the device inside the circle B, showing the distal end of the body proximal portion (1210) with the distal end of the pressurized-gas capsule (1212) within it, and a piercing mechanism (1220). Fig. 10B shows the device before activation, in the closed position and Fig. IOC shows the device after activation, in the open position. The piercing mechanism comprises a hollow tube (1221), open at the distal end (not shown) and closed at the proximal end. The closed end comprises a sharp tip (1223). In the lower portion of the closed tip is an opening (1222). At least part of the tube (1221) sits snugly, slidably and gas-tightly in a guidance shaft (1214). The open end of the tube is in fluid connection with a substance compartment (1242) and the nozzle (1240). For clarity, no substance capsule is shown.
Before activation (Fig. 10A and B), when the device is in the closed position, the piercer (1120) is in a raised position, so that the sharp tip (1223) is above the top of the capsule (1212) and the capsule (1212) is gas-tight. During activation, the piercer (1220) is forced downward, piercing the top of the capsule (1212).
After activation, (Fig. IOC), when the device is in the open position, the piercer (1120) is in a lowered position, so that the sharp tip (1223) and the opening (1222) are below the top of the capsule (1212).
During activation, there is a period of time after the piercer (1120) has entered the capsule (1212) but before the opening (1222) has entered the capsule. Since the piercer (1220) fits snugly and gas-tightly against the guidance shaft (1214), the gas capsule (1212) remains effectively sealed, with the gas therein unable to escape, until the opening (1222) is below the base of the guidance shaft (1214). Therefore, emptying of the gas capsule will be substantially independent of the speed at which the body proximal portion (1210) is moved into the body distal portion (1220), since, in normal use, the opening (1222) will become entirely uncovered in a time substantially shorter than the time needed to empty the capsule (1212) so that emptying of the capsule will be substantially independent of the speed at which the body proximal portion (1210) is moved into the body distal portion (1220), and the emptying time will depend substantially only on the size of the opening and the pressure within the canister. In preferred embodiments, the emptying time will be less than 500 ms.
In some embodiments, the gas capsule is opened by means of a piston mechanism. In Figs. 11-13, the piston is movable by means of a pair of levers, in Figs. 14-16, the piston is movable by means of a single lever and, in Figs. 17-21, the piston is movable by means of a magnet.
Fig. 11A-B, Fig. 12A and Fig. 12C show external views of a device (1300) with a pair of levers, Fig. 11C shows an exploded view of the device (1300), while Fig. 12B shows a section view along the line A-A of Fig. 12A and Fig. 12D shows a section view along the line A-A of Fig. 12C. Fig. 11A shows the device from the side, and Fig. 11B is a perspective view of the device from the bottom. Fig. 12A and Fig. 12B show the device in a closed position, while Fig. 12C and Fig. 12D show it in an open position.
In Figs. 11-12, the pair of levers and piston device (1300) comprises a nozzle (1240) with a removable cap (1250) at its distal end. In use, the removable cap (1250) would be removed before activation.
The body (1210) of the device is fixed at its distal end to the nozzle (1240) and at its proximal end to an end stop (1305). The shaft of the piston (1320) passes through the end stop (1305) and is rotatably fixed at its proximal end to the proximal ends of a pair of bendable levers (1330), with the distal ends of the bendable levers (1330) bendably attached to the distal end of the body (1210).
Figs. 12A and B show the device with a removable cap (1250) closing the distal end of the nozzle (1240), while Figs. 12C and D show the device without a cap (1250), so that the distal end of the nozzle (1250) is open, allowing gas and substance to escape therefrom.
As shown in Fig. 12B and D, the double lever and piston mechanism comprises a hollow tube (1321), open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown. In the closed position (Figs. 12A-B), the head of the piston (1320) is fitted snugly, slidably and air-tightly in the proximal end of the tube (1321). A portion of the shaft of the piston (1320) fits snugly, slidably and air-tightly in a guidance shaft (1214).
The activation mechanism comprises the pair of levers (1330) and the piston (1320). In the closed position (Figs. 12A and B), the levers are bent so that the piston (1320) is at the top of its travel with its head at least partially inside the tube (1321), thereby sealing the pressurized gas within the body (1310).
To activate the device (1300), the levers (1330) are pressed inward towards the body (1310), thereby moving the piston (1320) towards the proximal end of the device. This removes the head of the piston (1320) from the tube (1321), opening the tube and allowing pressurized gas to exit the body and pass up the tube.
io6 In the open position (Figs. 12C and D), the piston (1320) is at the bottom of its travel, with the head clear of the open end of the tube (1321) so that the opening is clear, allowing pressurized gas to exit the body and pass up the tube.
Figs. 13A-B show enlarged sectional side views of the portion of the device (1300) inside the circle C (Fig. 12B), showing the proximal end of the tube (1321) and the distal end of the shaft (1320). Fig. 13A shows the device (1300) before activation, in the closed position, and Fig. 13B shows the device after activation, in the open position.
Before activation (Fig. 13A), when the device is in the closed position, the head of the piston (1320) is in a raised position, so that it is within the tube (1321), preventing fluid connection between the interior of the body (1310) and the tube (1321). During activation, the piston (1320) moves downward, thereby opening the distal end of the tube (1321) and creating a fluid connection between the interior of the body (1310) and the tube (1321) and allowing the pressurized gas to travel through the tube and through the nozzle and be dispensed.
After activation, (Fig. 13B), when the device is in the open position, the head of the piston (1320) is in a lowered position, so that there is a fluid connection between the interior of the body (1310) and the tube (1321).
Fig. 14A-B and Fig. 15A show external views of a device (1400) with a single lever, Fig. 14C shows an exploded view of the device (1400), while Fig. 15B and Fig. 15C show section views along the line A-A of Fig. 15A. Fig. 14A shows the device from the side, and Fig. 14B is a perspective view of the device from the bottom. Fig. 15A and Fig. 15B show the device in a closed position, while Fig. 15C shows it in an open position.
In Figs. 13-15, the single lever and piston device (1400) comprises a nozzle (1240) with a removable cap (1450) at its distal end. In use, the removable cap (1450) would be removed before activation. The body (1410) of the device is fixed at its distal end to the nozzle (1240) and at its proximal end to an end stop (1405). The shaft of the piston (1420) passes through the end stop (1405) and is rotatably fixed at its proximal end to the proximal end of the lever (1430) by means of a pin (1425). In preferred embodiments, the lever (1430) is substantially in the shape of an "L", with a bend in it, so that its proximal portion, which is rotatably attached to the piston (1420), is, in the closed position, approximately perpendicular to the longitudinal axis of the piston (1420) and its distal portion, comprising its free end, is at an acute angle to the longitudinal axis of the shaft. The central or bend portion, where the proximal portion and the distal portion meet, is rotatably attached (1427) to the body such that the lever can rotate about an axis perpendicular to the main longitudinal axis of the device.
Figs. 15A and B show the device (1400) with a removable cap (1450) closing the distal end of the nozzle (1240), while Fig. 15C shows the device without the removable cap (1450), so that the distal end of the nozzle (1240) is open, allowing gas and substance to escape therefrom.
Fig. 16A-B shows enlarged sectional side views of the portion of the device (1400) inside the circle D, showing the proximal end of the tube (1321) and the distal end of the shaft (1420). Fig. 16A shows the device (1400) before activation, in the closed position and Fig. 16B shows the device after activation, in the open position.
As shown in Figs. 15B and C, and in the enlarged view in Figs. 16A-B, the single lever and piston mechanism comprises a hollow tube (1321), open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown. In the closed position (Fig. 16A), at least a portion of the head of the piston (1420) fits snugly, slidably and air-tightly in the proximal end of the tube (1321). A portion of the shaft of the piston (1420) fits snugly, slidably and air-tightly in a guidance shaft (1214).
The activation mechanism comprises the lever (1430) and the piston (1420). In the closed position (Figs. 15B and 16A), the upper portion of the lever (1430) is spaced outward from the body so that the piston (1320) is at the top of its travel with at least a portion of its head in the tube (1321), thereby preventing fluid connection between the interior of the body (1410) and the tube (1321). and sealing the pressurized gas within the body (1410).
To activate the device (1400), the lever is pressed inward towards the body (1410), thereby moving the piston (1420) towards the proximal end of the device. This removes the head of the piston (1420) from the tube (1321), opening the proximal end of the tube and creating a fluid connection between the interior of the body (1410) and the tube (1321), thereby allowing pressurized gas to exit the body (1410) and pass up the tube (1321).
In the open position (Fig. 15C and 16B), the piston (1420) is at the bottom of its travel, with the head clear of the open end of the tube (1321) so that the opening is clear and there is a fluid connection between the interior of the body (1410) and the tube (1321), allowing pressurized gas to exit the body and pass up the tube.
Fig. 17A-B shows external views of a device (1500) with a push-button and magnet and Fig.
io8 17C shows an exploded view of the device, while Fig. 18A-B and Fig. 19A-B show section views along the line A-A of Fig. 17A, with Fig. 19A-B showing an enlarged view of the region inside the circle E in Fig. 17A-B. Fig. 17A shows the device from the side and Fig. 17B is a perspective view of the device from the bottom. Fig. 18A and Fig. 19A show the device in a closed position, while Fig. 18B and Fig. 19B shows it in an open position.
In Figs. 17-18, the push-button and magnet device (1500) comprises a nozzle (1240) with a removable cap (1450) at its distal end. In use, the removable cap (1450) would be removed before activation.
The body (1510) of the device is fixed at its distal end to the nozzle (1240) and has a pushbutton (1530) slidably attached to its proximal end.
As shown in Figs. 17C, 18A-B and 19A-B, the push-button and magnet mechanism comprises a hollow tube (1321), open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown. In the closed position (Fig. 18A, Fig. 19A), at least a portion of the head of the piston (1520) fits snugly, slidably and air-tightly in the proximal end of the tube (1321). A portion of the shaft of the piston (1520) fits snugly, slidably and air-tightly in a guidance shaft (1514).
The activation mechanism comprises a first at least one magnet mounted (1526) inside the shaft of the piston (1520) or forming a portion of the shaft of the piston (1520), and a second at least one magnet (1536) attached to the push-button (1530) and, in the open position, substantially surrounding the piston (1420).
In some variants of this embodiment, the body (1510) is made in two pieces (1510A, 1510B) for ease of assembly. Similarly, the end stop (1520) is a separate piece. It surrounds the push-button (1530) and is fixed to the proximal part of the proximal portion of the body (1510A).
The push-button (1530) fits slidably on a guidance shaft (1514) so that, on depression of the push-button (1530), it slides smoothly into the body (1510).
In the closed position (Fig. 18A, Fig. 19A), the push button (1530) is at the bottom of its travel and the piston (1520) is at the top of its travel with at least a portion of its head in the tube (1321) thereby sealing the pressurized gas within the body (1410). In the closed position, the piston (1520) will not move of its own accord because the strengths of the magnets are sufficiently small, the distance between the push-button magnet (1536) and the
log piston magnet (1526) is sufficiently large, and the coefficients of friction are sufficiently large between, respectively, the piston (1520) and the guidance shaft (1514), the piston (1520) and the tube (1321) and between the guidance shaft (1514) and the push-button (1526).
To activate the device (1500), the push-button is pressed upwards into the body (1510), thereby moving the push-button magnet (1536) closer to the piston magnet (1526). The removable cap (1450) is configured such that a user can hold the device with fingers on the removable cap (1450) and thumb on the push-button (1530), so that, in closing his hand, bringing the fingers and thumb closer together, he presses the push button (1530) into the body (1410) of the device and activates the device.
At some point during the push-button's (1530) travel toward the distal end of the device, the second, push-button, magnet (1536) will become close enough to the first, piston, magnet (1526) that the magnetic attraction will overcome the friction forces and the piston will move towards the proximal end of the device. This removes the head of the piston (1520) from the tube (1321), opening the tube, creating a fluid connection between the interior of the body (1510) and the tube (1321) and allowing pressurized gas to exit the body (1510), pass through the tube (1321 and through the nozzle and be dispensed.
In the open position (Fig. 18B and Fig. 19B), the piston (1520) is at the bottom of its travel, with its head clear of the open end of the tube (1321) so that the opening is clear, there is a fluid connection between the interior of the body (1510) and the tube (1321), and the pressurized gas exits the body (1510), passes through the tube (1321) and through the nozzle and is dispensed.
Fig. 20A-B shows external views of a device (1600) with an activation controller and electromagnet, while Fig. 21 shows a section view along the line A-A of Fig. 20A. Fig. 20A shows the device from the side and Fig. 20B is a perspective view of the device from the bottom.
In Figs. 20-21, the activation controller and electromagnet device (1600) comprises a nozzle (1240) with a removable cap (1450) at its distal end. The body (1610) of the device is fixed at its distal end to the nozzle (1240).
Figs. 20 and 21 show the device with a removable cap (1450) closing the distal end of the nozzle (1240). In use, the removable cap (1450) would be removed before activation.
no As shown in Figs. 20-21, the activation controller and electromagnet mechanism comprises a hollow tube (1321) open at both the distal end and at the proximal end and in fluid connection with the nozzle (1240). For clarity, neither the substance compartment nor substance capsule is shown. In the closed position (Fig. 21), at least a portion of the head of the piston (1620) fits snugly, slidably and air-tightly in the proximal end of the tube (1321). A portion of the shaft of the piston (1620) fits snugly, slidably and air-tightly in a guidance shaft (1614) and at least one electromagnet (1636) is mounted outside of and at least partially surrounding the guidance shaft (1614). In some embodiments, the electromagnet (1636) is a part of the guidance shaft (1614).
The activation mechanism comprises the at least one magnet (1626) mounted inside the shaft of the piston (1620) or forming a portion of the shaft of the piston (1620), and the at least one electromagnet (1636) mounted outside of and at least partially surrounding the guidance shaft (1614).
In the closed position (Fig. 21), the piston (1620) is at the top of its travel with at least a portion of its head in the tube (1321), thereby sealing the pressurized gas within the body (1610).
To activate the device (1600), energy is supplied to the electromagnet, thereby creating a magnetic field inside the core of the electromagnet. The activation mechanism can be a button, slider, twist mechanism or other conventional mechanism (not shown) in physical communication with the device (1600) or a remote controller in wireless communication with the device (1600).
The magnetic attraction between the electromagnet and the piston (1620) causes the piston (1620) to move towards the proximal end of the device (1600). This removes the head of the piston (1620) from the tube (1321), creating a fluid connection between the interior of the body (1510) and the tube (1321), opening the tube and allowing pressurized gas to exit the body (1610), pass through the tube (1321) and through the nozzle (1240).
A remote controller can also be used with other embodiments. Some non-limiting examples include:
• The lever or levers can comprise a spring or spring-like material and, before activation, be held in a bent position by a catch or other retaining device. Activation of the remote controller releases the catch, allowing the spring lever(s) to relax and straighten and releasing the gas, as described hereinabove.
Ill • The lever or levers can comprise a spring and, before activation, be held by a catch with their distal end in the closed position, away from the body of the device. Activation of the remote controller releases the catch, allowing the spring to cause the lever distal end to rotate toward the body of the device and releasing the gas, as described hereinabove.
• The device can comprise a spring or a spring-like region and, before activation, the movable tube can be held in the closed position by a catch. Activation of the remote controller releases the catch, allowing the spring to move the movable tube towards the proximal end of the device, thereby piercing the gas capsule and releasing the gas, as described hereinabove.
• The device can comprise a spring or a spring-like region and, before activation, the pushbutton can be held in the closed position by a catch. Activation of the remote controller releases the catch, allowing the spring to move the pushbutton towards the distal end of the device, thereby releasing the gas, as described hereinabove.
• The device can comprise a motor configured, on activation, to move the movable tube towards the proximal end of the device, thereby piercing the gas capsule and releasing the gas, as described hereinabove.
• The device can comprise a motor configured, on activation, to move the piston out of the fixed tube, thereby releasing the gas, as described hereinabove.
In another embodiment, the amount of gas and/or the amount of substance deliverable by the device can be altered. The amount of substance delivered can be by changing the type of capsule, for non-limiting example, from a capsule containing one predetermined amount of substance to a capsule containing a different amount of substance, it can be by loading (for non-limiting example, via a syringe) different amounts of substance into a capsule or into a substance chamber, or by any means known in the art for loading a predetermined amount of substance into a substance chamber.
The amount of gas can be changed by changing the size of the gas capsule or by changing the pressure under which the gas is stored. Changing the size of the capsule is preferred, since changing the pressure typically changes the delivery characteristics.
Fig. 22A-B shows an embodiment of a device in which the size of the gas capsule can be changed and in which the gas capsule (1212) is separate from the substance capsule (not shown), allowing the same device to be used for different substances. Fig. 22A shows an exterior view of the device and Fig. 22B shows a side sectional view taken along the line BB in Fig.22A of the adjustable part of the device.
As shown in Fig.22A-B, the device comprises a nozzle (1240) and main body (1710). At the proximal end of the device (on the right) is an adjustable section, which comprises a removable housing (1760) configured to contain a gas capsule (1212, Fig.21B). The housing and body (1710) comprise matching screw threads (1765; not shown on the housing) allowing the housing to be screwed inward and outward so as to enlarge or shrink the space within. This ensures that, in use, the gas capsule (1212) is held snugly by the housing (1760) and body (1710), thereby ensuring proper operation of the device,
In use, in this embodiment, in a first step, the gas capsule is opened, allowing mixing of the gas and the contents of the substance capsule. In a second step, a valve is opened, allowing the gas-substance mixture to exit from the device, as described above.
In some embodiments, the device comprises a "double tap", where the drug container comprises a tube of predetermined length and relaxed cross-sectional area, with at least one flexible portion. In variants of these embodiments with flexible portions at both ends, the ends are swollen closed. Opening the valve simultaneously opens both ends of the drug container as well as the gas capsule, thus allowing use of large volumes (without increasing the size of the drug capsule or gas capsule), allowing these embodiments of the SipNose device to work with a capsules with different volumes (small to large).
Under some circumstances, for non-limiting example, if misuse of the device or of a dispensed substance is not unlikely, remote activation can be the preferred method of activation. Non-limiting examples of readily-misused substances are analgesics such as opioids, cannabis, cannabinoids and cannabis derivatives. Non-limiting examples of situations where misuse is not unlikely, independent of the substance dispensed, are patients suffering from confusion, who can have difficulty remembering how long to wait between doses (e.g., trying to dose themselves every hour instead of every 5 hours) and who may even have difficulty remembering how many times to dose themselves (e.g., was it once per day or three times a day), or patients who do not fully understand a dosing regimen (e.g., trying to dose themselves 3 times because "if one is good, then 3 is better"). With a remote controller, a caregiver or medical professional can control the dispensing, with the patient contacting the caregiver or medical professional to request a dose of the substance or the caregiver or medical professional contacting the patient, either remotely or in person, to remind him to place the device in the proper orifice or to place the device in the proper position and then, when the device is properly placed, activating the device or the remote controller so as to ensure that the patient receives the appropriate medication. The medical professional can ensure that the correct number of doses is dispensed, or refuse to dispense if, for example, an insufficient time has elapsed since a previous dispensing. With a remote controller, a caregiver or medical professional can allow dispensing of a dose after a predetermined time, with the patient dispensing the dose when he feels it is necessary. For example, for the control of breakthrough pain in cancer, it can be preferable for a patient to dose himself when the pain occurs, but, to avoid overdosing, a minimum time between administrations can be desirable. In such cases, the device can be automatically deactivated after administration, and reactivated, wither automatically or by a competent person, such as a medical professional or a trained caregiver, after the minimum time has passed.
A remote controller can also be useful for a patient, if the substance is likely to be valuable to a thief. With a remote controller, the dispenser and the controller can be kept separate, for example, in separate pockets, or one in a pocket and the other in a wallet or purse or hidden in a pouch or belt under the clothing. If, as is likely, the thief takes only the dispenser, it will be useless for the thief because he can not access the contents without the controller.
In preferred embodiments, the device comprises a dose controller configured to enable a user to determine at least one of how many doses remain in the device and how many doses have been used. The simplest dose counters are mechanical dose counters that count a "dose used" each time the device is activated. After a fixed number of activations, a device with a mechanical dose counter is deemed to be empty.
For a device, such as a blister pack which opens and empties a single-dose reservoir for each activation or a cartridge in which a fixed number of compartments are opened per activation, a simple counter is adequate to inform a user as to how many doses remain available, although such a counter can not determine how much substance has been wasted by, for example, not being removed from a blister during dosing.
Dose counters also use at least one sensor or a combination of at least one sensor and a mechanical counter, to determine either or both of doses used and doses remaining.
Note that, for a device with a large reservoir which delivers, as a dose, a fraction of the contents of the reservoir, drift during use, either electronic or mechanical, can result in the actual number of deliverable doses differing from the nominal number of doses contained in the device. Sensor-based dose counters can measure, for non-limiting example, pressure within a device, the weight of the device, the amount delivered per dose, the gas velocity at predetermined points within the device, and any combination thereof. If the device further contains a database, the amount of each dose can be stored and, at the least, totaled, to give the total amount used and, therefore, the amount remaining. In some embodiments, the data are downloadable, so that the variations in delivery pressure, amount used, delivery velocity, and any other stored parameter, can be stored elsewhere, and, as desired, plotted or further analyzed.
In some embodiments, the device, the capsule, and any combination thereof are "smart", comprising at least one of a controller configured to manipulate data and a communication means such that measured data can be downloaded for further manipulation elsewhere. In preferred embodiments, at least one of the device and the capsule comprises a database configured to store the data. Data can include, but are not limited to, a member of a group consisting of: device parameters such as delivery pressure, delivery time, amount used, delivery velocity, frequency of use, and any combination thereof; parameters of the patient, such as, but not limited to, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof; and any combination thereof. Communication between the system and a remote system is preferably wireless, although wired communication can be used.
In some variants, the system (the device, the capsule and any combination thereof) further comprises processing facilities that enable it to warn a user or a remote medical professional of such things as failure to properly deliver a dose, leakage in the device, a user's having difficulty in properly activating a device, a user's difficulty in following a treatment protocol, drift in device parameters, and any combination thereof.
In some embodiments, the system comprises a data
In some embodiments, the smart system comprises means of altering device parameters or of alerting a user, a carer or medical professional. In such embodiments, feedback is used to control at least one parameter of device use. The measured data, can be analyzed, either locally or remotely, and the results of the analysis can be used to alter either a device operating parameter or to alert a user, carer or medical professional to alter the timing of the doses or the number of doses. Sensors can include, but are not limited to, a pressure sensor, a velocity sensor, a mass flow sensor, a temperature sensor, and any combination thereof.
In the foregoing description, embodiments of the invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principals of the invention and its practical application, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.

Claims

A device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: a. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and c. a controller in communication with said activation mechanism wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state.
The device of claim 1, wherein said controller additionally comprises a communication mechanism.
The device of claim 1, wherein said communication mechanism is configured to receive a command selected from a group consisting of: a command to prevent said transition from said closed state to said open state, a command to allow said transition from said closed state to said open state, and any combination thereof.
The device of claim 1, additionally comprising a database.
The device of claim 4, wherein said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
6. The device of claim 1, wherein, during dispensing of said predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T.
7. The device of claim 1, wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT.
8. The device of claim 1, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
dP
c. said pressure rate, rfF ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms;
f. said predetermined period of time, dT→- O; and g. dT is in a range of about 0 to 500 millisecond; and h. any combination thereof.
9. The device of claim 1, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
10. The device of claim 1, additionally comprising at least one activation controller configured to activate said activation mechanism.
11. The device of claim 10, wherein said activation controller is either in physical communication with said device or in wireless communication with said device.
12. The device of claim 11, wherein said activation controller in physical communication with said device is selected from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
13. The device of claim 11, wherein said activation controller in wireless communication with said device is a remote control.
14. The device of claim 1, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
15. The device of claim 14, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state.
16. The device of claim 15, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said activation controller.
17. The device of claim 14, wherein at least start of movement of said piston relative to said fixed tube is controllable by said activation controller.
18. The device of claim 14, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
19. The device of claim 18, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
20. The device of claim 19, wherein said device comprises two said bendable levers.
21. The device of claim 12, wherein at least start of bending of at least one said lever is controllable by said activation controller.
22. The device of claim 19, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis.
23. The device of claim 22, wherein at least start of pivoting of said lever is controllable by said activation controller.
24. The device of claim 14, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
25. The device of claim 24, wherein said at least one second magnet is attached to a pushbutton slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state.
26. The device of claim 25, wherein at least start of sliding of said push-button is controllable by said activation controller.
27. The device of claim 24, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
28. The device of claim 27, wherein said activation controller controls start of energizing said electromagnet.
29. The device of claim 1, wherein said activation mechanism comprises at least one magnet.
30. The device of claim 29, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
31. The device of claim 30, wherein said activation mechanism comprises at least two said magnets.
32. The device of claim 31, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
33. The device of claim 32, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
34. The device of claim 31, wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
35. The device of claim 1, additionally comprising a dose counter.
36. The device of claim 1, additionally comprising at least one sensor.
37. The device of claim 36, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
38. The device of claim 37, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising: a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
39. The device of claim 38, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
40. The device of claim 1, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
41. The device of claim 40, wherein said gas entrains said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
42. The device of claim 41, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
43. The device of claim 42, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
44. The device of claim 40, wherein at least one said substance comprises a medicament.
45. The device of claim 33, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
46. The device of claim 40, further comprising a filter, said filter upstream of said at least one flowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and unde sired particles.
47. The device of claim 40, wherein at least one said flowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
48. The device of claim 40, wherein said at least one flowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
49. The device of claim 40, wherein said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L- DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5- hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d- propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
50. The device of claim 40, wherein said predefined volume comprises a substance capsule removably containable said device.
51. The device of claim 50, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true: a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance;
c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances;
i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule;
m. at least one said compartment is at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane;
o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
The device of claim 51, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
53. The device of claim 52, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
54. The device of claim 51, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
55. The device of claim 54, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
56. The device of claim 55, wherein said polygon has between three sides and 20 sides.
57. The device of claim 55, wherein said polygon is either a regular polygon or an irregular polygon.
58. The device of claim 54, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
59. The device of claim 51, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance capsule, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof.
60. The device of claim 51, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
61. The device of claim 51, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
62. The device of claim 51, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
63. The device of claim 50, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof.
64. The device of claim 50, wherein said substance capsule contains a single dose of said at least one flowable substance.
65. The device of claim 50, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
66. A device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end;
said device comprising: a. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and c. a database wherein said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
67. The device of claim 66, additionally comprising a controller in communication with said activation mechanism.
68. The device of claim 67, wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state.
69. The device of claim 66, wherein, during dispensing of said predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T.
70. The device of claim 66, wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT.
71. The device of claim 66, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
dP ^
c. said pressure rate, dT ' ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, dT→ O; and g. dT is in a range of about 0 to 500 millisecond; and any combination thereof.
72. The device of claim 66, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
73. The device of claim 66, additionally comprising at least one activation controller configured to activate said activation mechanism.
74. The device of claim 73, wherein said activation controller is either in physical communication with said device or in wireless communication with said device.
75. The device of claim 74, wherein said activation controller in physical communication with said device is selected from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
76. The device of claim 74, wherein said activation controller in wireless communication with said device is a remote control.
77. The device of claim 66, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
78. The device of claim 77, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state.
79. The device of claim 78, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said activation controller.
80. The device of claim 77, wherein at least start of movement of said piston relative to said fixed tube is controllable by said activation controller.
81. The device of claim 77, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
82. The device of claim 81, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
83. The device of claim 82, wherein said device comprises two said bendable levers.
84. The device of claim 82, wherein at least start of bending of at least one said lever is controllable by said activation controller.
85. The device of claim 81, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis.
86. The device of claim 85, wherein at least start of pivoting of said lever is controllable by said activation controller.
87. The device of claim 77, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
88. The device of claim 87, wherein said at least one second magnet is attached to a pushbutton slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state.
89. The device of claim 88, wherein at least start of sliding of said push-button is controllable by said activation controller.
90. The device of claim 87, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
91. The device of claim 90, wherein said activation controller controls start of energizing said electromagnet.
92. The device of claim 66, wherein said activation mechanism comprises at least one magnet.
93. The device of claim 92, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
94. The device of claim 93, wherein said activation mechanism comprises at least two said magnets.
95. The device of claim 94, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
96. The device of claim 95, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
97. The device of claim 94, wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
98. The device of claim 66, additionally comprising a dose counter.
99. The device of claim 66, additionally comprising at least one sensor.
100. The device of claim 99, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
101. The device of claim 100, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising: a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
102. The device of claim 101, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
103. The device of claim 66, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
104. The device of claim 103, wherein said gas entrains said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
105. The device of claim 104, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
106. The device of claim 105, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
107. The device of claim 103, wherein at least one said substance comprises a medicament.
108. The device of claim 103, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
109. The device of claim 103, further comprising a filter, said filter upstream of said at least one flowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and unde sired particles.
110. The device of claim 103, wherein at least one said flowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
111. The device of claim 103, wherein said at least one flowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
112. The device of claim 103, wherein said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L- DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5- hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d- propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
113. The device of claim 103, wherein said predefined volume comprises a substance capsule removably containable said device. The device of claim 113, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true: a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance; c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances;
i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule;
m. at least one said compartment is at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane;
o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
115. The device of claim 114, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
116. The device of claim 115, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
117. The device of claim 114, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
118. The device of claim 117, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
119. The device of claim 118, wherein said polygon has between three sides and 20 sides.
120. The device of claim 118, wherein said polygon is either a regular polygon or an irregular polygon.
121. The device of claim 117, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
122. The device of claim 114, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance capsule, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof.
123. The device of claim 114, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
124. The device of claim 114, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
125. The device of claim 114, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
126. The device of claim 113, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof.
127. The device of claim 113, wherein said substance capsule contains a single dose of said at least one flowable substance.
128. The device of claim 113, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
129. A device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: a. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state;
wherein, during dispensing of said predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T; further wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT; further wherein at least one of the following is held true:
(i) P is in a range of about 2 - 10 barg;
(ii) V is in a range of about 1 - 21 ml;
dP
(iii) said pressure rate, dT ;
(iv) said pressure rate dP/dT is greater than about 0.0001 barg /ms;
(v) said volume rate dV/dT is greater than about 0.001 ml /ms;
(vi) said predetermined period of time, dT→■ O;
(vii) dT is in a range of about 0 to 500 millisecond; and
any combination thereof.
130. The device of claim 129, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
131. The device of claim 129, additionally comprising at least one activation controller configured to activate said activation mechanism.
132. The device of claim 131, wherein said activation controller is either in physical communication with said device or in wireless communication with said device.
133. The device of claim 132, wherein said activation controller in physical communication with said device is selected from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
134. The device of claim 132, wherein said activation controller in wireless communication with said device is a remote control.
135. The device of claim 129, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
136. The device of claim 135, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state.
137. The device of claim 136, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said activation controller.
138. The device of claim 135, wherein at least start of movement of said piston relative to said fixed tube is controllable by said activation controller.
139. The device of claim 135, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
140. The device of claim 139, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
141. The device of claim 140, wherein said device comprises two said bendable levers.
142. The device of claim 140, wherein at least start of bending of at least one said lever is controllable by said activation controller.
143. The device of claim 139, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis.
144. The device of claim 143, wherein at least start of pivoting of said lever is controllable by said activation controller.
145. The device of claim 135, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
146. The device of claim 145, wherein said at least one second magnet is attached to a pushbutton slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state.
147. The device of claim 146, wherein at least start of sliding of said push-button is controllable by said activation controller.
148. The device of claim 146, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
149. The device of claim 148, wherein said activation controller controls start of energizing said electromagnet.
150. The device of claim 129, wherein said activation mechanism comprises at least one magnet.
151. The device of claim 150, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
152. The device of claim 151, wherein said activation mechanism comprises at least two said magnets.
153. The device of claim 152, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
154. The device of claim 153, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
155. The device of claim 152, wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
156. The device of claim 129, additionally comprising a dose counter.
157. The device of claim 129, additionally comprising at least one sensor.
158. The device of claim 157, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
159. The device of claim 158, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising: a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
160. The device of claim 159, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
161. The device of claim 129, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
162. The device of claim 161, wherein said gas entrains said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
163. The device of claim 162, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
164. The device of claim 163, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
165. The device of claim 161, wherein at least one said substance comprises a medicament.
166. The device of claim 161, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
167. The device of claim 161, further comprising a filter, said filter upstream of said at least one flowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and unde sired particles.
168. The device of claim 161, wherein at least one said flowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
169. The device of claim 161, wherein said at least one flowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
170. The device of claim 161, wherein said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L- DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5- hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d- propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
171. The device of claim 161, wherein said predefined volume comprises a substance capsule removably containable said device.
172. The device of claim 171, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true: a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance;
c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances;
i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule;
m. at least one said compartment is at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane;
o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
173. The device of claim 172, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
174. The device of claim 173, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
175. The device of claim 172, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
176. The device of claim 175, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
177. The device of claim 176, wherein said polygon has between three sides and 20 sides.
178. The device of claim 176, wherein said polygon is either a regular polygon or an irregular polygon.
179. The device of claim 175, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
180. The device of claim 172, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance capsule, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof.
181. The device of claim 172, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
182. The device of claim 172, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
183. The device of claim 172, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
184. The device of claim 171, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof.
185. The device of claim 171, wherein said substance capsule contains a single dose of said at least one flowable substance.
186. The device of claim 171, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
187. A smart device for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, said device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: a. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; b. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; wherein during dispensing of said at least one predetermined amount of gas under said predetermined pressure, said gas is released from said gas capsule within a predetermined time, T; further wherein said activation mechanism is in wireless communication with a remote controller, such that reconfiguration from said closed state to said open state can be enabled remotely.
188. The device of claim 187, wherein said device is configured to dispense said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; and (b) volume rate of dV /dT.
189. The device of claim 188, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
dP
. , -* GO
c. said pressure rate, αΤ ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, dT→■ O; and g. dT is in a range of about 0 to 500 millisecond; h. and any combination thereof.
190. The device of claim 187, wherein said gas comprises air, nitrogen, oxygen, carbon dioxide, helium, neon, argon, xenon and any combination thereof.
191. The device of claim 187, wherein said activation mechanism comprises a member of a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
192. The device of claim 191, wherein said hollow tube is attached at its distal end to a distal portion of said device and said gas capsule is attached to a proximal portion of said device, said device distal portion and said device proximal portion being slidable with respect to each other in a direction substantially parallel to said main longitudinal axis such that, in said open state, a distance between said sharp point and said device proximal end is shorter than said distance between said sharp point and said device proximal end in said closed state.
193. The device of claim 192, wherein at least start of movement of said hollow tube relative to said gas capsule is controllable by said remote controller.
194. The device of claim 192, wherein at least start of movement of said piston relative to said fixed tube is controllable by said remote controller.
195. The device of claim 191, wherein said piston is rotatably attached substantially at its proximal end to at least one lever and is slidable in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
196. The device of claim 195, wherein at least a portion of said at least one lever is bendable, said at least one lever being bent in said closed state and transition from said closed state to said open state being effected by at least partially straightening said at least one lever.
197. The device of claim 196, wherein said device comprises two said bendable levers.
198. The device of claim 196, wherein at least start of bending of at least one said lever is controllable by said remote controller.
199. The device of claim 195, wherein said at least one lever pivots on a hinge, transition from said closed state to said open state being effected by pivoting a distal end of said lever towards said main longitudinal axis.
200. The device of claim 199, wherein at least start of pivoting of said lever is controllable by said remote controller.
201. The device of claim 191, wherein said piston comprises at least one first magnet and said proximal end of said device comprises at least one second magnet.
202. The device of claim 201, wherein said at least one second magnet is attached to a pushbutton slidably attached to said proximal end of said device, said push-button being slidable with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device such that, in said open state, a distance between said first magnet and said second magnet is shorter than said distance between said first magnet and said second magnet in said closed state.
203. The device of claim 202, wherein at least start of sliding of said push-button is controllable by said remote controller.
204. The device of claim 201, wherein said second magnet is an electromagnet, transition between said closed state and said open state being effected by energizing said electromagnet.
205. The device of claim 204, wherein said remote controller controls start of energizing said electromagnet.
206. The device of claim 187, wherein said activation mechanism comprises at least one magnet.
207. The device of claim 206, wherein said at least one magnet is selected from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
208. The device of claim 207, wherein said activation mechanism comprises at least two said magnets.
209. The device of claim 208, wherein a first at least one said magnet is movable relative to a second at least one said magnet.
210. The device of claim 209, wherein said predetermined amount, V, of said gas is deliverable consequent to said movement of said first at least one magnet relative to said second at least one magnet.
211. The device of claim 208 wherein said activation mechanism comprises a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device; and a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a movable piston comprising at least one magnet, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
212. The device of claim 187, additionally comprising a dose counter.
213. The device of claim 187, additionally comprising at least one sensor.
214. The device of claim 213, wherein said sensor is selected from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
215. The device of claim 213, additionally comprising a feedback mechanism, configured to change at least one delivery parameter selected from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, an interval between two said activations and any combination thereof, said feedback mechanism comprising: a. at least one said sensor, configured to sense a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof;
b. a processor, configured to score at least one member of said sensing group according to a predetermined scale; and,
c. a regulator, configured to (a) alter at least one said delivery parameter, (b) provide a notification to alter said interval between two said activations, and any combination thereof.
216. The device of claim 215, wherein said activation mechanism controls at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
217. The device of claim 216, wherein said device additionally comprises a predefined volume configured to contain a least one flowable substance.
218. The device of claim 217, wherein said gas entrains said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
219. The device of claim 218, wherein said predetermined distribution is selected from a group consisting of: a homogeneous distribution, a heterogeneous distribution.
220. The device of claim 219, wherein said heterogeneous distribution is selected from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
221. The device of claim 217, wherein at least one said substance comprises a medicament.
222. The device of claim 217, wherein said substance is selected from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
223. The device of claim 217, further comprising a filter, said filter upstream of said at least one flowable substance, said filter adapted to remove from said carrier gas at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and unde sired particles.
224. The device of claim 217, wherein at least one said flowable substance is stored under either an inert atmosphere or under vacuum to prevent reactions during storage.
225. The device of claim 217, wherein said at least one flowable substance comprises a material selected from a group consisting of: a medicament, a medicament precursor, a gas, and any combination thereof.
226. The device of claim 217, wherein said at least one flowable substance comprises a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L- DOPA, Carbio-Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5- hydroxytryptamine (5-HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist- antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d- propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy-methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
227. The device of claim 217, wherein said predefined volume comprises a substance capsule removably containable said device.
228. The device of claim 227, wherein said substance capsule is characterized by a main longitudinal axis, said substance capsule comprising a number n of compartments; at least one of the following being true: a. the number n of said compartments is an integer in a range from 1 to 10;
b. at least one said compartment contains at least one said flowable substance; c. at least one said compartment has cross-section with shape selected from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, at least two said compartments have different volumes;
e. for said number n of compartments being an integer greater than 1, at least two said compartments have the same volume;
f. for said number n of compartments being an integer greater than 1, at least two said compartments have different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, at least two said compartments have the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, at least two said compartments contain different substances;
i. for said number n of compartments being an integer greater than 1, at least two said compartments contain the same substance;
j. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, at least two said compartments are disposed sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, at least two said compartments are disposed angularly around said main longitudinal axis of said substance capsule; m. at least one said compartment is at the centroid of said substance capsule;
n. for said number n of compartments greater than 1, at least two said compartments are separated by a frangible membrane;
o. for said number n of compartments greater than 1, said plurality of substances mix during said dispensing; and
p. for said number n of compartments greater than 1, said plurality of substances react during said dispensing.
229. The device of claim 228, wherein the centroid of said angularly positioned at least one compartment is at a position selected from a group consisting of: at the same distance from the centroid of said substance capsule, at different distances from the centroid of said substance capsule, and any combination thereof.
230. The device of claim 229, wherein said different distances are arranged in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
231. The device of claim 228, wherein the shape of the said substance capsule is selected from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
232. The device of claim 231, wherein said cylinder has cross-section selected from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
233. The device of claim 232, wherein said polygon has between three sides and 20 sides.
234. The device of claim 232, wherein said polygon is either a regular polygon or an irregular polygon.
235. The device of claim 231, wherein at least one of the shape and size of the cross-section of said substance capsule is selected from a group consisting of: substantially constant along said substance capsule's main longitudinal axis, changes along said substance capsule's main longitudinal axis, and any combination thereof.
236. The device of claim 228, wherein the disposition of the main longitudinal axis of at least one of said compartments is selected from a group consisting of: parallel to the main longitudinal axis of the substance device, spirally disposed with respect to the main longitudinal axis of the substance capsule, an angle to the main longitudinal axis of the substance capsule, and any combination thereof.
237. The device of claim 228, wherein the shape of said main longitudinal axis of said at least one of said compartments is selected from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
238. The device of claim 228, wherein, for any two compartments, the main longitudinal axes can be the same or they can be different.
239. The device of claim 228, wherein said substance capsule is configured such that rupture of at least one said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
240. The device of claim 227, wherein said substance capsule forms a single unit with a member of a group consisting of a nosepiece of said device, a mouthpiece of said device and said gas capsule and any combination thereof.
241. The device of claim 227, wherein said substance capsule contains a single dose of said at least one flowable substance.
242. The device of claim 227, wherein a plurality of said substance capsules comprise a cartridge, said substance capsules being independently openable, each said independently-openable substance capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
243. A method for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of: a. providing a device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: i. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and iii. a controller in communication with said activation mechanism b. activating said device, said activation opening said gas capsule; and c. dispensing said gas through said distal end wherein said controller comprises at least two states, an operative state and an inoperative state, said controller being configured, in said inoperative state, to prevent said transition from said closed state to said open state and configured, in said operative state, to allow said transition from said closed state to said open state.
244. The method of claim 243, additionally comprising step of providing said controller with a communication mechanism.
245. The method of claim 243, additionally comprising step of receiving, via said communication mechanism, a command selected from a group consisting of: a command to prevent said transition from said closed state to said open state, a command to allow said transition from said closed state to said open state, and any combination thereof.
246. The method of claim 243, additionally comprising step of providing a database.
247. The method of claim 246, additionally comprising step of providing in said database a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
248. The method of claim 243, additionally comprising step of, during dispensing of said predetermined amount of gas under said predetermined pressure, releasing said gas from said gas capsule within a predetermined time, T.
249. The method of claim 243, additionally comprising step of dispensing said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT.
250. The method of claim 243, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml; d.P
c. said pressure rate, dT ' ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, dT→ O; g. dT is in a range of about 0 to 500 millisecond; and any combination thereof.
251. The method of claim 243, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
252. The method of claim 243, additionally comprising steps of providing at least one activation controller and activating said activation mechanism via said activation controller.
253. The method of claim 252, additionally comprising step of providing said activation controller either in physical communication with said device or in wireless communication with said device.
254. The method of claim 253, additionally comprising step of selecting said activation controller in physical communication with said device from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
255. The method of claim 254, additionally comprising step of providing said controller in wireless communication with said device as a remote control.
256. The method of claim 252, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
257. The method of claim 256, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state.
258. The method of claim 257, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
259. The method of claim 256, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
260. The method of claim 256, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
261. The method of claim 260, additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
262. The method of claim 261, additionally comprising step of providing said device with two said bendable levers.
263. The method of claim 261, additionally comprising step of controlling at least start of bending of at least one said lever by said activation controller.
264. The method of claim 260, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis.
265. The method of claim 264, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
266. The method of claim 256, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet.
267. The method of claim 266, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said push-button with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
268. The method of claim 267, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
269. The method of claim 266, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet.
270. The method of claim 269, additionally comprising step of energizing said electromagnet by means of an activation controller.
271. The method of claim 270, additionally comprising step of comprising said activation mechanism of at least one magnet.
272. The method of claim 271, additionally comprising step of selecting said at least one magnet from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
273. The method of claim 272, additionally comprising step of comprising said activation mechanism of at least two said magnets.
274. The method of claim 273, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
275. The method of claim 274, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
276. The method of claim 273, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with i6o respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
277. The method of claim 243, additionally comprising step of providing a dose counter.
278. The method of claim 243, additionally comprising step of providing at least one sensor.
279. The method of claim 278, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
280. The method of claim 278, additionally comprising steps of: providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
281. The method of claim 280, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
282. The method of claim 243, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
283. The method of claim 282, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
i6i
284. The method of claim 283, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
285. The method of claim 284, additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
286. The method of claim 282, additionally comprising step of comprising at least one said flowable substance of a medicament.
287. The method of claim 282, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
288. The method of claim 282, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
289. The method of claim 282, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
290. The method of claim 282, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
291. The method of claim 282, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative- hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio- Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy- methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (Ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
292. The method of claim 282, additionally comprising step of removably containing a substance capsule within said predefined volume.
293. The method of claim 292, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps: a. selecting the number n of said compartments to be an integer in a range from 1 to 10;
b. providing at least one said compartment containing at least one said flowable substance;
c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume;
f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance;
j. for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule;
m. disposing at least one said compartment at the centroid of said substance capsule; n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
294. The method of claim 293, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
295. The method of claim 294, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
296. The method of claim 294, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
297. The method of claim 296, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
298. The method of claim 297, additionally comprising step of providing said polygon with between three sides and 20 sides.
299. The method of claim 298, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon.
300. The method of claim 297, additionally comprising step of selecting at least one of the shape and size of the cross-section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
301. The method of claim 293, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
302. The method of claim 293, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
303. The method of claim 293, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different.
304. The method of claim 293, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances. i66
305. The method of claim 292, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
306. The method of claim 292, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
307. The method of claim 292, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
308. A method for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of: a. providing a device characterized by a main longitudinal axis, a proximal end and a distal end, said gas is dispensable through said distal end; said device comprising: i. a removable, openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and iii. a database b. activating said device, said activation opening said gas capsule; and c. dispensing said gas through said distal end wherein said database can comprise a member of a group consisting of: amount of medicament delivered in a dose, total amount of medicament delivered in a plurality of doses, delivery pressure, delivery time, delivery velocity, frequency of use, time between uses, breathing rate, depth of breathing, blood pressure, body temperature, pulse rate, blood levels of a predetermined substance, levels of the predetermined substance in exhaled air, and any combination thereof.
309. The method of claim 308, additionally comprising step of providing a controller in communication with said activation mechanism.
310. The method of claim 309, additionally comprising step of providing said controller with at least two states, an operative state and an inoperative state, said controller, in said inoperative state, preventing said transition from said closed state to said open state and, in said operative state, allowing said transition from said closed state to said open state.
311. The method of claim 308, additionally comprising step of, during dispensing of said predetermined amount of gas under said predetermined pressure, releasing said gas from said gas capsule within a predetermined time, T.
312. The method of claim 308, additionally comprising step of dispensing said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT.
313. The method of claim 308, wherein at least one of the following is held true: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
dP
c. said pressure rate, dT " ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, dT→■ O; and g. dT is in a range of about 0 to 500 millisecond; and any combination thereof.
314. The method of claim 308, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
315. The method of claim 308, additionally comprising steps of providing at least one activation controller and activating said activation mechanism via said activation controller.
316. The method of claim 310, additionally comprising step of providing said activation controller either in physical communication with said device or in wireless communication with said device.
317. The method of claim 316, additionally comprising step of selecting said activation controller in physical communication with said device from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
318. The method of claim 316, additionally comprising step of providing said controller in wireless communication with said device as a remote control.
319. The method of claim 308, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
320. The method of claim 319, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state.
321. The method of claim 319, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
322. The method of claim 319, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
323. The method of claim 319, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
324. The method of claim 323, additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
325. The method of claim 324, additionally comprising step of providing said device with two said bendable levers.
326. The method of claim 324, additionally comprising step of controlling at least start of bending of at least one said lever by said activation controller.
327. The method of claim 323, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis.
328. The method of claim 327, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
329. The method of claim 319, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet.
330. The method of claim 329, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said push-button with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
331. The method of claim 330, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
332. The method of claim 329, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet.
333. The method of claim 332, additionally comprising step of energizing said electromagnet by means of an activation controller.
334. The method of claim 308, additionally comprising step of comprising said activation mechanism of at least one magnet.
335. The method of claim 334, additionally comprising step of selecting said at least one magnet from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
336. The method of claim 335, additionally comprising step of comprising said activation mechanism of at least two said magnets.
337. The method of claim 336, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
338. The method of claim 337, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
339. The method of claim 336, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
340. The method of claim 308, additionally comprising step of providing a dose counter.
341. The method of claim 308, additionally comprising step of providing at least one sensor.
342. The method of claim 341, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
343. The method of claim 341, additionally comprising steps of: providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
344. The method of claim 343, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
345. The method of claim 308, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
346. The method of claim 345, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
347. The method of claim 346, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
348. The method of claim 347, additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
349. The method of claim 345, additionally comprising step of comprising at least one said flowable substance of a medicament.
350. The method of claim 345, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
351. The method of claim 345, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
352. The method of claim 345, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
353. The method of claim 345, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
354. The method of claim 345, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative- hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio- Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N2O), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy- methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (Ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
355. The method of claim 345, additionally comprising step of removably containing a substance capsule within said predefined volume.
356. The method of claim 355, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps: a. selecting the number n of said compartments to be an integer in a range from 1 to 10;
b. providing at least one said compartment containing at least one said flowable substance;
c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume;
f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance;
j. for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule;
m. disposing at least one said compartment at the centroid of said substance capsule; n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
357. The method of claim 356, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
358. The method of claim 357, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
359. The method of claim 357, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
360. The method of claim 359, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
361. The method of claim 360, additionally comprising step of providing said polygon with between three sides and 20 sides.
362. The method of claim 361, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon.
363. The method of claim 360, additionally comprising step of selecting at least one of the shape and size of the cross-section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
364. The method of claim 356, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
365. The method of claim 356, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
366. The method of claim 356, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different.
367. The method of claim 356, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
368. The method of claim 355, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
369. The method of claim 355, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
370. The method of claim 355, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
371. A method for delivering for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of: a. providing a device for delivering said at least one predetermined amount, V, of said gas under said predetermined pressure P, to said natural orifice of said body, said device characterized by a main longitudinal axis, a proximal end and a distal end;
said device comprising:
i. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure; and
ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state;
b. activating said delivery device, said activation opening said gas capsule; and c. dispensing said gas through said distal end
thereby releasing said gas from said gas capsule in a predetermined time, T, and delivering said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; (b) volume rate of dV /dT; wherein at least one of the following is held true:
(a) P is in a range of about 2 - 10 barg;
(b) V is in a range of about 1 - 21 ml;
(c) said pressure rate, dT ;
(d) said pressure rate dP/dT is greater than about 0.0001 barg /ms;
(e) said volume rate dV/dT is greater than about 0.001 ml /ms;
(f) said predetermined period of time, dT→ O; and
(g) dT is in a range of about 0 to 500 millisecond; and any combination thereof.
372. The method of claim 371, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
373. The method of claim 371, additionally comprising steps of providing at least one activation controller and activating said activation mechanism via said activation controller. l78
374. The method of claim 373, additionally comprising step of providing said activation controller either in physical communication with said device or in wireless communication with said device.
375. The method of claim 374, additionally comprising step of selecting said activation controller in physical communication with said device from a group consisting of a pushable button, a slidable contact, a twistable contact and any combination thereof.
376. The method of claim 374, additionally comprising step of providing said controller in wireless communication with said device as a remote control.
377. The method of claim 371, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
378. The method of claim 377, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state.
379. The method of claim 378, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
380. The method of claim 377, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
381. The method of claim 377, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
382. The method of claim 381, additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
383. The method of claim 382, additionally comprising step of providing said device with two said bendable levers.
384. The method of claim 382 additionally comprising step of controlling at least start of bending of at least one said lever by said activation controller.
385. The method of claim 381, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis.
386. The method of claim 385, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
387. The method of claim 377, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet.
388. The method of claim 387, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said push-button with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
389. The method of claim 388, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
i8o
390. The method of claim 387, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet.
391. The method of claim 390, additionally comprising step of energizing said electromagnet by means of an activation controller.
392. The method of claim 371, additionally comprising step of comprising said activation mechanism of at least one magnet.
393. The method of claim 392, additionally comprising step of selecting said at least one magnet from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
394. The method of claim 393, additionally comprising step of comprising said activation mechanism of at least two said magnets.
395. The method of claim 394, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
396. The method of claim 395, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
397. The method of claim 394, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
398. The method of claim 371, additionally comprising step of providing a dose counter.
399. The method of claim 371, additionally comprising step of providing at least one sensor.
400. The method of claim 399, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
i8i
401. The method of claim 399, additionally comprising steps of: providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
402. The method of claim 401, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT.
403. The method of claim 371, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
404. The method of claim 403, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
405. The method of claim 404, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
406. The method of claim 405, additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
407. The method of claim 403, additionally comprising step of comprising at least one said flowable substance of a medicament.
408. The method of claim 403, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
409. The method of claim 403, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
410. The method of claim 403, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
411. The method of claim 403, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
412. The method of claim 403, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative- hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio- Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N2O), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy- methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
413. The method of claim 403, additionally comprising step of removably containing a substance capsule within said predefined volume.
414. The method of claim 413, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps: a. selecting the number n of said compartments to be an integer in a range from 1 to 10;
b. providing at least one said compartment containing at least one said flowable substance;
c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume;
f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance;
j. for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule;
m. disposing at least one said compartment at the centroid of said substance capsule; n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
415. The method of claim 414, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
416. The method of claim 415, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
417. The method of claim 415, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
418. The method of claim 417, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
419. The method of claim 418, additionally comprising step of providing said polygon with between three sides and 20 sides.
420. The method of claim 419, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon.
421. The method of claim 418, additionally comprising step of selecting at least one of the shape and size of the cross-section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
422. The method of claim 414, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
423. The method of claim 414, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
424. The method of claim 414, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different.
425. The method of claim 414, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
426. The method of claim 413, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
427. The method of claim 413, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
428. The method of claim 413, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
429. A method for delivering at least one predetermined amount, V, of gas under a predetermined pressure P, to a natural orifice of a body, comprising steps of: a. providing a smart device for delivering said at least one predetermined amount, V, of said gas under said predetermined pressure P, to said natural orifice of said body, said device characterized by a main longitudinal axis, a proximal end and a distal end;
said device comprising:
i. an openable gas capsule for containing said predetermined amount of gas under said predetermined pressure;
ii. an activation mechanism with at least two states, an open state and a closed state, said activation mechanism configured to open said gas capsule and release said gas from said gas capsule upon transition from said closed state to said open state; and
iii. a remote controller in wireless communication with said activation mechanism; and
b. activating said remote controller;
thereby remotely controlling reconfiguring said activation mechanism from said closed state to said open state, releasing said gas from said gas capsule within a predetermined time, T, and dispensing said predetermined amount of gas under said predetermined pressure.
430. The method of claim 429, additionally comprising step of delivering said predetermined amount of gas under said predetermined pressure through said distal end in (a) pressure rate of dP/dT; and (b) volume rate of dV /dT.
431. The method of claim 430, additionally comprising at least one of the following steps: a. P is in a range of about 2 - 10 barg;
b. V is in a range of about 1 - 21 ml;
dP
—→ (B
c. dr ; d. said pressure rate dP/dT is greater than about 0.0001 barg /ms; e. said volume rate dV/dT is greater than about 0.001 ml /ms; f. said predetermined period of time, dT→ O; g. dT is in a range of about 0 to 500 millisecond; and
any combination thereof.
432. The method of claim 429, additionally comprising step of comprising said compressed gas of air, nitrogen, oxygen, carbon dioxide, helium, neon and xenon and any combination thereof.
433. The method of claim 429, additionally comprising step of selecting said activation mechanism from a group consisting of: (i) a movable hollow tube characterized by an open distal end, a closed proximal end and an opening in a side of said tube, said closed proximal end characterized by a sharp point configured to penetrate a membrane closing said gas capsule, said closed state characterized by said gas capsule not in fluid communication with said device distal end, said open state characterized by said gas capsule in fluid communication with said device distal end via said opening; (ii) a fixed hollow tube characterized by an open distal end and an open proximal end; said tube proximal end pluggable by a piston, said closed state characterized by said proximal end plugged by said piston such that said device proximal end is not in fluid communication with said device distal end; said open state characterized by said device proximal end in fluid communication with said device distal end via said tube.
434. The method of claim 433, additionally comprising steps of attaching said hollow tube at its distal end to a distal portion of said device and attaching said gas capsule to a proximal portion of said device, and sliding said device distal portion and said device proximal portion with respect to each other in a direction substantially parallel to said main longitudinal axis thereby, in said open state, having a distance between said sharp point and said device proximal end shorter than said distance between said sharp point and said device proximal end in said closed state.
435. The method of claim 434, additionally comprising step of controlling at least start of movement of said hollow tube relative to said gas capsule by said activation controller.
436. The method of claim 433, additionally comprising step of controlling at least start of movement of said piston relative to said fixed tube by said activation controller.
437. The method of claim 433, additionally comprising steps of rotatably attaching said piston substantially at its proximal end to at least one lever and sliding said piston with respect to said tube in a direction substantially parallel to said device main longitudinal axis by means of said at least one lever.
438. The method of claim 437 additionally comprising steps of providing said lever with at least a portion of said at least one lever bendable, such that said at least one lever is bent in said closed state, and transitioning from said closed state to said open state by at least partially straightening said at least one lever.
439. The method of claim 438, additionally comprising steps of providing said device with two said bendable levers.
440. The method of claim 438, additionally comprising step of controlling at least start of bending of said lever by said activation controller.
441. The method of claim 437, additionally comprising steps of pivoting said at least one lever on a hinge, and transitioning from said closed state to said open state by pivoting a distal end of said lever towards said main longitudinal axis.
442. The method of claim 441, additionally comprising step of controlling at least start of pivoting of said lever by said activation controller.
443. The method of claim 433, additionally comprising steps of providing said piston with at least one first magnet and providing said proximal end of said device with at least one second magnet.
444. The method of claim 443, additionally comprising steps of attaching said at least one second magnet to a push-button, slidably attaching said push-button to said proximal end of said device, sliding said push-button with respect to said device distal portion in a direction substantially parallel to said main longitudinal axis of said device thereby, in said open state, having a distance between said first magnet and said second magnet shorter than said distance between said first magnet and said second magnet in said closed state.
445. The method of claim 444, additionally comprising step of controlling at least start of sliding of said push-button by said activation controller.
446. The method of claim 443, additionally comprising steps of providing said second magnet as an electromagnet, and transitioning between said closed state and said open state by energizing said electromagnet.
447. The device of claim 446, additionally comprising step of controlling start of energizing said electromagnet by means of said remote controller.
448. The method of claim 429, additionally comprising step of comprising said activation mechanism of at least one magnet. igo
449. The method of claim 448, additionally comprising step of selecting said at least one magnets from a group consisting of a permanent magnet, an electromagnet and any combination thereof.
450. The method of claim 449, additionally comprising step of comprising said activation mechanism of at least two said magnets.
451. The method of claim 450, additionally comprising step of moving a first at least one said magnet relative to a second at least one said magnet.
452. The method of claim 451, additionally comprising step of delivering said predetermined amount, V, of said gas is consequent to said moving of said first at least one magnet relative to said second at least one magnet.
453. The method of claim 450, additionally comprising step of comprising said activation mechanism of a first magnet at said proximal end of said device and non-movable with respect to said proximal end of said device, a fixed hollow tube characterized by an open distal end and an open proximal end and a movable piston comprising at least one magnet; providing a closed state by plugging said tube proximal end by said piston such that said device proximal end is not in fluid communication with said device distal end; and providing said open state by magnetically removing said piston from said tube, thereby providing fluid communication between said device proximal end and said device distal end via said tube.
454. The method of claim 429, additionally comprising step of providing a dose counter.
455. The method of claim 429, additionally comprising step of providing at least one sensor.
456. The method of claim 455, additionally comprising step of selecting said sensor from a group consisting of: pressure sensor, velocity sensor, mass flow sensor, temperature sensor, and any combination thereof.
457. The method of claim 455, additionally comprising steps of providing a feedback mechanism; changing at least one delivery-related parameter by means of the same; selecting said delivery-related parameter from a group consisting of: said predetermined amount, V, of gas, said predetermined pressure P, said pressure rate dP/dT, said volume rate dV/dT, said predetermined period of time, dT, said interval between two said activations and any combination thereof; sensing, by means of at least one said sensor, a member of a sensing group consisting of: at least one said delivery parameter, mass flow rate, gas velocity, plume angle, pulse rate, blood pressure, temperature, and any combination thereof; scoring, by means of a processor, at least one member of said sensing group according to a predetermined scale; and, via a regulator, (a) altering at least one said delivery parameter, (b) providing a notification to alter said interval between two said activations, and any combination thereof.
458. The method of claim 457, additionally comprising step of controlling, by means of said activation mechanism, at least one of the following parameters: said pressure rate dP/dT, said volume rate dV/dT, and said predetermined period of time, dT,
459. The method of claim 429, additionally comprising step of containing a least one flowable substance within a predefined volume of said device.
460. The method of claim 459, additionally comprising step of entraining in said gas said at least one flowable substance such that said at least one flowable substance has a predetermined distribution within said carrier gas.
461. The method of claim 460, additionally comprising step of selecting said predetermined distribution from a group consisting of: a homogeneous distribution, or a heterogeneous distribution.
462. The method of claim 461 additionally comprising step of selecting said heterogeneous distribution from a group consisting of: an arbitrary distribution, a distribution in which the density of said at least one flowable substance within said mixture follows a predetermined pattern, and any combination thereof.
463. The method of claim 459, additionally comprising step of comprising at least one said flowable substance of a medicament.
464. The method of claim 459, additionally comprising steps of selecting said flowable substance from a group consisting of a gas, a liquid, a powder, an aerosol, a slurry, a gel, a suspension and any combination thereof.
465. The method of claim 459, additionally comprising steps of providing a filter, and positioning said filter upstream of said at least one flowable substance, and removing from said gas, via said filter, at least one selected from a group consisting of particulates, bacteria, viruses, moisture, and undesired particles.
1Q2
466. The method of claim 459, additionally comprising steps of storing at least one said flowable substance under either an inert atmosphere or under vacuum to prevent reactions during storage.
467. The method of claim 459, additionally comprising steps of comprising said at least one flowable substance of a material selected from a group consisting of: a medicament, a medicament precursor, a compressed gas, an inert gas, and any combination thereof.
468. The method of claim 459, additionally comprising steps of comprising said at least one flowable substance of a medicament selected from a group consisting of saline, natural substances, medicaments for treatments for allergic rhinitis, medicaments for treatments for osteoporosis, vaccinations and immunizations, sexual dysfunction drugs, medicaments for treatments for B12 deficiency, medicaments for smoking cessation, medicaments for treatment of gynecological problems, medicaments for treatment of other women's health issues, medicaments for general anesthetics, local anesthetics, opioid analgesics, agonist-antagonists and antagonists, antitussives, medicaments for treatment of motor disorders, antiepileptics, antipsychotics (neuroleptics), sedative- hypnotics, anxiolytics, and centrally acting muscle relaxants, medicaments for treatments for anxiety disorders, skeletal muscle relaxants, medicaments for treatments for Parkinson's disease, medicaments for treatments for Alzheimer's disease, medicaments for treatment of allergic rhinitis, steroids, corticosteroids, Flonase, Patanase, Beconase, antihistamines, Astelin, Otrivin, Livostin, Theramax, Avamys, Lufeel, Sinofresh, Nasonex, Nasocort, Veramyst, medicaments for treatment of osteoporosis, Miacalcin, Fortical and Stadol, medicaments for vaccinations and immunizations, LAVIN, and influenza vaccines including FluMist, NasalFent. Calcitonin, parathyroid hormone, Neurotransmitters and neuromodulators, acetylcholine (ACH), Anticholinergic drugs, adenosine triphosphate (ATP), aspartate (Asp), beta-amyloid, beta-endorphin, bradykinin, dopamine (DA), L-DOPA, Carbio- Dopa, epinephrine, dynorphins, endomorphins, enkephalins, 5-hydroxytryptamine (5- HT), Sumatriptan, Imitrex, Migranal, Zolmitriptan, Zomig, Gamma-aminobutyric acid (GABA), glutamate (glu), glycine, histamine, leptin, nerve growth factor and other growth factors), norepinephrine, nitric oxide, Substance P. alfentanil, desflurane, enflurane, etomidate, fentanyl, halothane, isoflurane, ketamine, methohexital, methoxyflurane, midazolam, morphine, nitrous oxide (N20), propofol, sevoflurane, Sufentanil, Sublimase, thiopental, benzocaine, bupivacaine, cocaine, lidocaine, prilocaine, procaine, ropivacaine, tetracaine, Opioid analgesics, agonist-antagonists, and antitussives, agonists, codeine, diphenoxylate, fentanyl, heroin and other opiods, cannabis and cannabinoids, hydrocodone, 1-alpha-acetyl-methadol, levomethadyl acetate, loperamide, meperidine, methadone, morphine, oxycodone, d-propoxyphene, combinations of opioids plus acetaminophen and asa, and tramadol, agonist/antagonists and antagonists, buprenorphine, butorphanol, nalbuphine, nalorphine, naloxone, naltrexone, nalmefene, pentazocine, codeine, dextromethorphan, and hydrocodone, medicaments for treatment of Parkinson's disease and motor disorders, amantadine, apomorphin, baclofen, benzodiazepines, benztropine, bromocriptine, carbidopa, cyclobenzaprine, dantrolene, dopamine, entacapone, haloperidol, L-DOPA, pergolide, pramiprexole, ropinerole, selegiline (deprenyl), trihexyphenidyl, rasagiline, azilect, selegiline, ladostigil, rotigotine, neupro, mono amine oxidase inhibitor, COMT inhibitor, antiepileptics, acetazolamide, carbamazepine, clonazepam, diazepam, ethosuximide, felbamate, gabapentin, Lamotrigine, lorazepam, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproic acid, Vigabatrin, Midazolam, antidepressants, amitriptyline, bupropion, citalopram, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, phenelzine, sertraline, trazodone, tranylcypromine, venlafaxine, antimanic drugs, carbamazepine, lithium carbonate valproic acid, antipsychotics (neuroleptics), chlorpromazine (CPZ), clozapine, fluphenazine, haloperidol, olanzapine, quetiapine, risperidone, sertindole, thioridazine, thiothixene, ziprasidone, sedative-hypnotics, anxiolytics, and centrally acting muscle relaxants, alprazolam, chloral hydrate, diphenhydramine, flumazenil, flurazepam, hydroxyzine, lorazepam, oxazepam, phenobarbital, temazepam, triazolam, zaleplon, Zolpidem, anxiety disorders and skeletal muscle relaxants, alprazolam, chlorazepate, chlordiazepoxide, diazepam, flumazenil (antagonist), lorazepam, oxazepam, amphetamine, caffeine, ephedrine, methamphetamine, methylphenidate, phentermine, sibutramine, disulfiram, ethanol, methanol, naltrexone, atropine, scopolamine, ketamine, lysergic acid diethylamide (LSD), MDMA (methylene dioxy- methyl amphetamine), mescaline, phencyclidine (PCP), donabinol, marijuana/THC, organic solvents, nicotine, Pentobarbital, neuroprotective compounds, neuroprotective peptides, neuroprotective factors, davunetide, anti-schizophrenic drugs, anti-depression drugs, comtan, Entacopone, anti ADHD agents, and anti ADHD drugs as Methylphenidrate (ritalin), anti-autism and anti-autism symptoms drugs, medicaments for treatment of Alzheimer's disease, donepezil, galantamine, rivastigmine, Tacrine, insulin, Detemir, Novolin, Humulin, insulin-like hormone, dopamine agonist and dopamine antagonist and any combination thereof.
469. The method of claim 459, additionally comprising step of removably containing a substance capsule within said predefined volume.
470. The method of claim 469, additionally comprising steps of characterizing said substance capsule is by a main longitudinal axis, and providing said substance capsule with a number n of compartments; additionally comprising at least one of the following steps: a. selecting the number n of said compartments to be an integer in a range from 1 to 10;
b. providing at least one said compartment containing at least one said flowable substance;
c. selecting cross-sectional shape of at least one said compartment from a group consisting of: wedge shaped, circular, oval, elliptical, polygonal, annular, and any combination thereof;
d. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different volumes;
e. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same volume;
f. for said number n of compartments being an integer greater than 1, providing at least two said compartments with different cross-sectional areas;
g. for said number n of compartments being an integer greater than 1, providing at least two said compartments with the same cross-sectional area;
h. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing different substances;
i. for said number n of compartments being an integer greater than 1, providing at least two said compartments containing the same substance;
j. for said number n of compartments being an integer greater than 1, disposing at least two said compartments coaxially around said main longitudinal axis of said substance capsule;
k. for said number n of compartments being an integer greater than 1, disposing at least two said compartments sequentially along said main longitudinal axis of said substance capsule;
1. for said number n of compartments greater than 1, disposing at least two said compartments angularly around said main longitudinal axis of said substance capsule;
m. disposing at least one said compartment at the centroid of said substance capsule; n. for said number n of compartments greater than 1, separating at least two said compartments by a frangible membrane;
o. for said number n of compartments greater than 1, mixing said plurality of substances during said dispensing; and
p. for said number n of compartments greater than 1, reacting said plurality of substances during said dispensing.
471. The method of claim 470, additionally comprising step of positioning the centroid of said angularly positioned at least one compartment in a position selected from a group consisting of: at the same distance from the centroid of said capsule, at different distances from the centroid of said capsule, and any combination thereof.
472. The method of claim 471, additionally comprising steps of arranging said different distances in a manner selected from a group consisting of: arbitrarily arranged, arranged in a pattern, and any combination thereof.
473. The method of claim 470, additionally comprising step of selecting a shape of said substance capsule from a group consisting of: cylindrical, spherical, elliptical, ovoid, pillow-shaped, football-shaped, stellate and any combination thereof.
474. The method of claim 473, additionally comprising step of selecting cross-section of said cylinder from a group consisting of: circular, oval, elliptical, lenticular, polygonal and any combination thereof.
475. The method of claim 474, additionally comprising step of providing said polygon with between three sides and 20 sides.
476. The method of claim 475, additionally comprising step of providing said polygon as either a regular polygon or an irregular polygon.
477. The method of claim 474, additionally comprising step of selecting at least one of the shape and size of the cross-section of said capsule from a group consisting of: substantially constant along said capsule's main longitudinal axis, changing along said capsule's main longitudinal axis, and any combination thereof.
478. The method of claim 470, additionally comprising step of selecting the manner in which at least one of said compartment's main longitudinal axis is disposed from a group consisting of: parallel to the main longitudinal axis of the capsule, spirally disposed with respect to the main longitudinal axis of the capsule, an angle to the main longitudinal axis of the capsule, and any combination thereof.
479. The method of claim 470, additionally comprising step of selecting the shape of said main longitudinal axis of said at least one of said compartments from a group consisting of: straight, forming a regular curve, forming an irregular curve, and any combination thereof.
480. The method of claim 470, additionally comprising steps of providing main longitudinal axes for any two compartments that are the same or that are different.
481. The method of claim 470, additionally comprising steps of providing said capsule such that rupturing said frangible membrane enables at least one of mixing and reaction of at least two of said flowable substances.
482. The method of claim 469, additionally comprising steps forming a single unit of said capsule with at least one of a group consisting of a nosepiece of said delivery device, a mouthpiece of said delivery device and a container for said carrier gas.
483. The method of claim 469, additionally comprising steps of containing a single dose of said at least one flowable substance within said capsule.
484. The method of claim 469, additionally comprising steps of comprising a cartridge of a plurality of said capsules, said capsules being independently openable, each said independently-openable capsule comprising a member of a group selected from (a) a single dose of said at least one flowable substance, (b) multiple doses of said at least one flowable substance, (c) carrier, (d) compressed gas and (e) any combination thereof.
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EP3645088A4 (en) * 2017-06-29 2021-07-21 Sipnose Ltd Adjustable dosing delivery and multi sectioned drug compartment
US11116914B2 (en) 2014-11-09 2021-09-14 Sipnose Ltd. Device and method for aerosolized delivering of substance to a natural orifice of the body
US11278682B2 (en) 2014-11-09 2022-03-22 Sipnose Ltd. Device and method for aerosolized delivery of substance to a natural orifice of the body
US11383048B2 (en) 2013-08-22 2022-07-12 Sipnose Ltd. Device to deliver a predetermined amount of a substance to a natural orifice of the body
US11452826B2 (en) 2016-03-24 2022-09-27 Nicoventures Trading Limited Mechanical connector for electronic vapor provision system
US11471618B2 (en) 2014-11-09 2022-10-18 Sipnose Ltd. Adjustable dosing delivery and multi sectioned drug compartment
US11963946B2 (en) 2021-04-22 2024-04-23 Universitätsspital Basel MDMA treatment to enhance acute emotional effects profile of LSD, psilocybin, or other psychedelics

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11383048B2 (en) 2013-08-22 2022-07-12 Sipnose Ltd. Device to deliver a predetermined amount of a substance to a natural orifice of the body
US11116914B2 (en) 2014-11-09 2021-09-14 Sipnose Ltd. Device and method for aerosolized delivering of substance to a natural orifice of the body
US11278682B2 (en) 2014-11-09 2022-03-22 Sipnose Ltd. Device and method for aerosolized delivery of substance to a natural orifice of the body
US11471618B2 (en) 2014-11-09 2022-10-18 Sipnose Ltd. Adjustable dosing delivery and multi sectioned drug compartment
US11452826B2 (en) 2016-03-24 2022-09-27 Nicoventures Trading Limited Mechanical connector for electronic vapor provision system
EP3645088A4 (en) * 2017-06-29 2021-07-21 Sipnose Ltd Adjustable dosing delivery and multi sectioned drug compartment
US11963946B2 (en) 2021-04-22 2024-04-23 Universitätsspital Basel MDMA treatment to enhance acute emotional effects profile of LSD, psilocybin, or other psychedelics

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