WO2010113159A1 - Devices and methods for enhancing drug absorption rate - Google Patents
Devices and methods for enhancing drug absorption rate Download PDFInfo
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- WO2010113159A1 WO2010113159A1 PCT/IL2010/000275 IL2010000275W WO2010113159A1 WO 2010113159 A1 WO2010113159 A1 WO 2010113159A1 IL 2010000275 W IL2010000275 W IL 2010000275W WO 2010113159 A1 WO2010113159 A1 WO 2010113159A1
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- cannula
- tissue
- apertures
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- patient
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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
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/1413—Modular systems comprising interconnecting elements
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3546—Range
- A61M2205/3569—Range sublocal, e.g. between console and disposable
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
- A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
-
- 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
- A61M2230/20—Blood composition characteristics
- A61M2230/201—Glucose concentration
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
Definitions
- some embodiments disclosed herein include an ambulatory portable infusion device that can be attached to the user's/patient's body and dispense doses of fluids to the patient's body. More particularly, some embodiments of the present disclosure are directed to a skin adherable infusion device that includes a soft cannula provided with a plurality of openings/holes spaced apart from one another around and along the cannula, to dispense fluid to the patient's subcutaneous tissue. The disclosure also includes embodiments directed to a method for improving fluid delivery absorption into the patient's subcutaneous tissue, and thus, to the systemic circulation is described herein.
- the terms “fluid” and “drug” refer to any therapeutic fluid, including but not limited to insulin.
- Tight glycemic control is essential in patients who require insulin for the treatment of diabetes, and its benefits have been demonstrated in several prospective clinical trials such as in the Diabetes Control and Complications Trial (DCCT) and in the U.K. Prospective Diabetes Study (UKPDS), (N Engl J Med 329:977-986, 1993, Lancet 352:854-865, 1998).
- DCCT Diabetes Control and Complications Trial
- U.K. Prospective Diabetes Study U.K. Prospective Diabetes Study
- Regimens involving multiple daily injections (“MDI") of insulin and/or continuous subcutaneous insulin injection (“CSII" or using insulin pumps) are designed to achieve tight glycemic control, attempting to mimic physiologic insulin secretion.
- the normal pancreas regulates insulin secretion to counteract alterations (i.e., elevations or drops) in blood glucose levels and maintain substantially constant glucose levels regardless diet or daily activity, i.e., regulating insulin and glucose in a closed loop mode.
- a complex array of physiological events occurs prior to eating (often referred-to as the cephalic phase of insulin secretion) which prepares the pancreas for immediate release of preformed insulin when blood glucose levels increase in response to food intake.
- This immediate insulin secretion prepares the tissues (primarily muscle and liver) to rapidly take up glucose molecules and thereby prevent severe postprandial hyperglycemia.
- RHI regular human insulin
- Insulin molecules from the depot diffuse through a surface in a first order process according to the following equation:
- ⁇ is related in direct proportion to the surface area of the depot (A) and inverse proportion to the depot volume (V).
- 3,076,457 discloses a hypodermic needle having an aperture at the tip and also having an opening which extends along the side of the shaft for part of its length.
- U.S. Pat. No. 6,261,272 discloses a metal needle having pores in its walls and a sharp tip. The porous needle can be connected to a fluid delivery device. Gross mainly relates to the production process of drilling a cut extending across the external surface of the side of the needle shaft and the external aperture area is greater than the internal area. Another "infiltration cannula" is described in U.S. Patent Application published as 2007/0106234. A metal porous needle is connected to a hub which is held by the operator during administration of drug into the subcutaneous tissue.
- the needles that penetrate the skin are also serving as infiltrating means (sprinkler needle). Needles made of metal or other rigid materials suffer from significant drawbacks, particularly when long term insertion is required (e.g., during several days) because they cause constant pricking sensation and continuous microtraumas during body movements. These limitations are further augmented in diabetic patients using insulin pumps who need continuous insulin administration around the clock.
- Insulin pumps deliver rapid acting insulin 24 hours a day through a cannula placed under the skin.
- the insulin total daily dose (“TDD") is divided into basal and bolus doses.
- Basal insulin is delivered continuously over 24 hours, and keeps the blood glucose levels in range (i.e., euglycemia) between meals and overnight.
- Diurnal basal rates can be pre-programmed or manually changed according to various daily activities.
- Insulin boluses are typically delivered before or during meals to counteract carbohydrates loads or during episodes of high blood sugar levels.
- Conventional insulin pumps include two types of pumps: a portable pager-like device that delivers insulin via a long tubing infusion set (hereinafter “pager pump”) and a skin adherable tubeless dispensing patch (hereinafter "patch pump”).
- page pump a portable pager-like device that delivers insulin via a long tubing infusion set
- patch pump skin adherable tubeless dispensing patch
- This cannula has a single opening at the distal end, and thus a single insulin depot is formed upon each bolus or basal dose administration.
- devices, systems and methods which provide a drug (e.g., insulin) infusion device and a method for accelerating and/or enhancing the drug absorption in tissue.
- This acceleration can be implemented by increasing the depot's surface to volume (A/V) ratio in the tissue (e.g., subcutaneous, intradermal, cutaneous).
- a device that delivers insulin into the body and can concomitantly monitor body glucose (e.g., blood glucose, ISF glucose) levels is provided, as well as a method for accelerating insulin absorption. This acceleration can be implemented by increasing the tissue depot's surface to volume (A/V) ratio.
- body glucose e.g., blood glucose, ISF glucose
- a device which is miniature, discreet, economical for users/patients and highly cost effective is provided, as well as a method for accelerating insulin absorption by increasing the subcutaneous depot's surface to volume (A/V) ratio.
- a device that contains a miniature skin securable dispensing patch unit that can continuously dispense insulin is provided as well as a method for accelerating insulin absorption by increasing the subcutaneous depot's surface to volume (A/V) ratio.
- a device that comprises insulin dispensing patch unit that can be remotely controlled is provided and a method for accelerating insulin absorption by increasing the subcutaneous depot's surface to volume (A/V) ratio.
- a miniature skin securable patch that can continuously dispense insulin and monitor body glucose concentration levels and a method accelerating insulin absorption by increasing the subcutaneous depot's surface to volume (A/V) ratio.
- a miniature skin securable patch that can continuously dispense insulin and continuously monitor body glucose concentration levels and a method accelerating insulin absorption by increasing the subcutaneous depot's surface to volume (A/V) ratio.
- a device in some embodiments, includes a closed or semi-closed loop system that is capable of monitoring glucose levels and dispensing insulin according to the sensed glucose levels and a method for accelerating insulin absorption by increasing the subcutaneous depot's surface to volume (A/V) ratio.
- Some embodiments of the present disclosure are directed to a drug delivery device for dispensing of a drug or other therapeutic fluid into a body of a user/patient.
- the device may include a reservoir retaining a drug, a cannula insertable into a tissue of the body of a user, and a pump for dispensing the drug from the reservoir into the tissue via the cannula.
- the cannula may comprise an elongated tube having a plurality of apertures spaced around and/or along a wall of the elongated tube (hereinafter a "soft sprinkler cannula” or a “sprinkler cannula” or a “sprinkler”).
- the plurality of apertures is configured for delivering the drug into the tissue.
- the tube may be soft/ flexible.
- the soft tube can be made from a polymer (e.g., Teflon®).
- the plurality of apertures forms/corresponds to a plurality of depots for the fluid.
- the plurality of apertures causes/results in an increase in absorption rate of the fluid in the tissue, and thus, in the body of the user/patient.
- the plurality of depots may further include an effective diffusion area substantially larger than an effective diffusion area formed from a single aperture forming a single depot.
- the cannula of the device can be provided with a penetrating member having a sharp tip.
- the penetrating member is capable of longitudinally traversing through the cannula. After cannula insertion into the body, the penetrating member can be retracted and the cannula is being retained within the tissue.
- the cannula may be retained within the tissue, e.g., for 2 to 7 days, or preferably for about 3 days.
- the device includes a dispensing unit (or a dispensing patch unit), and in some embodiments, the device may further include a remote control unit (also referred-to as "remote control" or "RC").
- a remote control unit also referred-to as "remote control” or "RC”
- Such an RC may be capable of communicating with the dispensing unit and may enable at least one of: programming of therapeutic fluid delivery, receiving user input, and data acquisition.
- the dispensing unit may comprise a pump.
- the pump can include a syringe with a movable plunger.
- the pump may include a peristaltic pump including a rotatable member configured for squeezing a delivery tube.
- the dispensing unit can be connected to a tissue (e.g., subcutaneous) insertable cannula through which drug (e.g., insulin) is delivered to the body of a user/patient.
- the dispensing unit can be comprised of two parts: a disposable part ("DP") and a reusable part ("RP").
- the DP may include at least the reservoir, and the RP may include at least a portion of the pump.
- the DP can include a disposable part housing and the RP can include a reusable part housing. Upon connection of the two parts or housings, the dispensing unit becomes operable, enabling drug flow from the reservoir to the tissue/body of the patient.
- a cradle unit (also referred-to as "cradle") is provided, which enables dispensing unit disconnection and reconnection upon patient's discretion.
- the cradle can be a flat sheet that adheres to the skin.
- a sprinkler cannula can be inserted into a tissue compartment (e.g., subcutaneous) through a dedicated passageway in the cradle unit.
- the sprinkler cannula can be inserted manually or automatically using a designated inserter device at various insertion angles.
- a cannula for dispensing of a fluid to a body of a user/patient the cannula is provided and comprises one or more of an elongated tube having a plurality of apertures spaced apart around and/or along a wall of the elongated tube.
- the plurality of apertures is configured for delivering a drug into the tissue of a user/patient.
- a connector may also be provided on a proximal end of the tube for establishing fluid communication between a fluid delivery device and the cannula, where the cannula is insertable into tissue by using a rigid penetrating member having a sharp tip.
- the plurality of apertures results-in/causes an increase in an absorption rate of the fluid in the body of the user/patient.
- the plurality of apertures forms/corresponds to a plurality of depots for the fluid, and the plurality of depots include an effective diffusion area substantially larger than an effective diffusion area formed from a single aperture forming a single depot.
- the plurality of apertures may be configured with substantially similar dimensions.
- at least one aperture of the plurality of apertures is configured with one or more dimensions different from another aperture of the plurality of apertures.
- the cannula comprises a tip, and the tip is provided with an opening which may include a self-sealable septum.
- one or more of the plurality of apertures of the cannula include at least one unidirectional valve.
- a method for increasing absorption rate of a therapeutic fluid into a tissue of the body of a user/patient may include one or more of the following steps: providing a cannula for dispensing of the therapeutic fluid into a tissue of the body of a patient, where the cannula includes an elongated soft tube having a plurality of apertures disposed around and/or along a wall of the elongated soft tube, the plurality of apertures being configured for delivering therapeutic fluid (e.g., a drug) into the tissue of the user/patient, and a connector may be provided on a proximal end of the elongated soft tube for establishing fluid communication between a fluid delivery device and the cannula.
- therapeutic fluid e.g., a drug
- the method may also include inserting the cannula into a patient's tissue via a rigid penetrating member having a sharp tip and dispensing the therapeutic fluid through the cannula.
- the therapeutic fluid flows through the plurality of apertures resulting-in/causing an increase in the absorption rate of the therapeutic fluid in the tissue/body of the patient.
- Some embodiments of the present disclosure are directed to a soft cannula having a plurality of pores/openings/apertures in its side walls (hereinafter a "soft sprinkler cannula” or a “sprinkler cannula” or a “sprinkler”) such that upon drug administration a plurality of depots are formed.
- a soft sprinkler cannula or a “sprinkler cannula” or a “sprinkler”
- Such pores are preferably spaced apart from one another around an along the side walls of the cannula.
- At least one pore is located so that at least one depot is formed in the cutaneous tissue.
- the absorption rate of insulin is influenced by the circulation of blood in the vicinity of the injection site, and insulin absorption (for example) at the injection site is enhanced with such increased blood flow. Since cutaneous tissue is more vascular than subcutaneous tissue compartments, insulin delivered according to some embodiments to the cutaneous tissue, absorbs more rapidly than insulin delivered subcutaneously. Such insulin delivery is via at least some embodiments of the present disclosure which include a sprinkler cannula positioned in an intradermal tissue, for example. An associated method according to some embodiments enhances therapeutic fluid absorption from the injection site into the systemic circulation.
- FIGs. la-b illustrate an infusion device with a vertical (FIG. Ia) and skewed (FIG. Ib) subcutaneously inserted sprinkler cannula according to some embodiments of the disclosure.
- FIG. 2 illustrates a pager pump with an infusion set and a sprinkler cannula according to some embodiments of the disclosure.
- FIG. 3 illustrates a skin adherable port with a sprinkler cannula and a syringe for fluid administration via the cannula according to some embodiments of the disclosure.
- FIGs. 4a-b illustrate a two-part pump adherable directly (FIG. 4a) and via a cradle unit (FIG. 4b) to the patient's skin according to some embodiments of the disclosure.
- FIGs. 5a-c illustrate cross sectional views of: a skin adherable cradle (FIG. 5a) and a sprinkler cannula before (FIG. 5b) and after (FIG. 5c) insertion through a cradle opening according to some embodiments of the disclosure.
- FIGs. 6a-b illustrate spatial views of a cradle after horizontal (FIG. 6a) and skewed (FIG. 6b) sprinkler cannula insertion according to some embodiments of the disclosure.
- FIG. 7 illustrates an infusion device that is composed of a skin adherable cradle, a dispensing unit that can be disconnected from the cradle, and a remote control unit that contains a blood glucose monitor according to some embodiments of the disclosure.
- FIG. 8 illustrates a dispensing unit that is composed of a reusable part and a disposable part according to some embodiments of the disclosure.
- FIGs. 9a-c illustrate a spatial view of a cradle (FIG. 9a), and a normal (FIG. 9b) and magnified
- FIGs. 9c bottom views of a sprinkler cannula according to some embodiments of the disclosure.
- FIGs. lOa-b illustrate a cross sectional normal (FIG. 10a) and magnified (FIG. 10b) views of a cradle and a skewed sprinkler cannula according to some embodiments of the disclosure.
- FIGs. 1 la-b illustrate a spatial view of skewed sprinkler cannula before (FIG. 1 Ia) and after (FIG. 1 Ib) insertion through an opening within a cradle according to some embodiments of the disclosure.
- FIGs. 12a-b illustrate a normal (FIG. 12a) and magnified (FIG. 12b) views of a sprinkler cannula having a self sealed tip according to some embodiments of the disclosure.
- FIG. 13 illustrates a two-part dispensing unit connected to a skin adherable cradle and a skewed sprinkler cannula according to some embodiments of the disclosure.
- FIGs. 14a-b illustrate cross sectional views of a two-part dispensing unit before (FIG. 14a) and after (FIG. 14b) connection to a skin adherable cradle and a skewed sprinkler cannula according to some embodiments of the disclosure.
- FIGs. 15a-c illustrate cross sectional views of fluid (e.g., insulin) depots emerging from a subcutaneous cannula.
- fluid e.g., insulin
- FIG. 15a illustrates one depot emerging from a cannula.
- FIG. 15b illustrates a vertical sprinkler cannula and drug depots emerging from the cannula holes.
- FIG. 15c illustrates a skewed sprinkler cannula and drug depots emerging from the cannula holes according to some embodiments of the disclosure.
- FIG. 16 illustrates a magnified view of a sprinkler cannula having holes and comprising unidirectional valves according to some embodiments of the disclosure.
- FIGs. 17a-c illustrate a dispensing unit (or patch unit) that contains a dispensing apparatus and a sensing apparatus according to some embodiments of the disclosure.
- the patch unit is connected to a cradle and a sprinkler cannula that includes a sensing element.
- FIG. 17a illustrates a cross sectional view of the patch, cradle and sprinkler cannula with the sensing element.
- FIGs. la-b illustrate embodiments of an infusion device 1 that can deliver therapeutic fluid (e.g., insulin) into the body of a patient through a soft cannula 6 that includes holes 66 along its longitudinal axis (hereinafter a "sprinkler cannula").
- Therapeutic fluid(s) can be delivered to several tissues such as the cutaneous tissue, subcutaneous compartment 4, soft tissues (e.g., muscles), or blood vessels (e.g., veins or arteries).
- the sprinkler cannula 6 can be inserted into the subcutaneous tissue 4 in various angles with respect to the skin surface, e.g., perpendicularly (or vertically) (see FIG. Ia), horizontally or in skewed/tilted manner (see FIG.
- the sprinkler cannula may be provided with a plurality of holes to enable higher drug absorption rates in the tissue by increasing the total surface area of the drug depots emerging from the sprinkler cannula holes.
- a single volume of drug i.e., a dose
- the total surface area of all depots is higher than that of the single depot delivered from a conventional cannula which has a single opening (typically at the cannula tip) to allow drug exit.
- FIG. 2 illustrates an infusion device according to some embodiments that includes a pump 700.
- Therapeutic fluid can be delivered through an "infusion set", which may include a tube 702, a port 76 attachable to the patient's skin (e.g., the port can be adhered to the skin via an adhesive layer), a connector 77, and a sprinkler cannula 6 (with holes 66).
- the connector 77 allows disconnection of the pump 700 and tube 702 from the port 76 upon patient's discretion.
- FIG. 3 illustrates a device according to some embodiments for drug delivery to the body.
- the device includes a sprinkler cannula 6 through which the drug is delivered and a skin adherable port 500.
- the port 500 can be adhered to the body via an adhesive tape 504, for example, and is connected to the sprinkler cannula 6 having holes 66.
- a self-sealable rubber septum 502 can be provided which allows for repeated piercing by a needle 18, for example, for establishing fluid communication between a syringe 188 (or other drug delivery device) and the sprinkler cannula 6.
- the drug can be insulin administered to Type 1 or Type 2 diabetic patients.
- FIGs. 4a-b illustrate a device for drug delivery.
- the device includes a skin adherable dispensing patch 10 (also referred-to as “patch” or “dispensing unit”) and a cannula 6 with holes 66.
- FIG. 4a illustrates a cross sectional view of the dispensing patch 10 that is adhered to the patient's skin.
- the patch 10 can be composed of two parts, which may be, according to some embodiments, a reusable part 100 and a disposable part 200.
- the dispensing patch 10 can be remotely controlled by a remote control or controlled directly using switches/buttons 15 (hereinafter “operating switches”) located on the reusable part 100 of the dispensing patch 10.
- the remote control can include a dedicated remote control, a cellular phone, a PC, a laptop, a Personal Digital Assistant, a watch, a medial player (e.g., iPod), a smart phone (e.g., iPhone), and the like.
- the switches 15 can include buttons, keys, a keypad, a touch sensitive user interface, a voice commander and the like.
- a sprinkler cannula 6 can be included which emerges from the disposable part 200, and can be in fluid communication with a fluid reservoir that is contained within the disposable part.
- FIG. 4b illustrates a cross sectional view of a dispensing patch 10 that can be connected to a skin adherable cradle 20. The dispensing patch 10 can be disconnected and reconnected from and to the cradle 20 upon patient's discretion.
- FIGs. 5a-c illustrate the insertion of sprinkler cannula 6 through a passageway 213 of skin adherable cradle 20 and into subcutaneous tissue 4.
- FIG. 5a illustrates a cross sectional view of the cradle 20 adhered to the skin, where the cradle 20 includes a protrusion which includes the passageway 213.
- FIG. 5b illustrates the insertion of a cannula cartridge 90 through the cradle passageway 213, where the cannula cartridge 90 can be composed of at least a penetrating member 92 (e.g., a needle) and sprinkler cannula 6 that includes holes 66.
- a penetrating member 92 e.g., a needle
- FIG.5c illustrates the connection of the dispensing patch 10 to the cradle 20.
- the patch 10 can be comprised of a first portion (e.g., a reusable part 100) having operating switches/buttons 15 according to some embodiments of the present disclosure, and a second portion (e.g., a disposable part 200).
- a recess 216 at the bottom of the patch may include a connecting lumen 215 which upon connection of the patch 10 to the cradle 20, the recess 216 receives the cradle protrusion and the connecting lumen 215 enables fluid communication between the reservoir, located in the second portion, and the sprinkler cannula 6.
- the patch 10 can be disconnected, and reconnected from and to the cradle 20 upon patient's discretion.
- FIGs. 6a-b illustrate a portion of the cradle 20 according to some embodiments which includes a sprinkler cannula 6 with holes 66.
- the cradle includes a passageway 213 through which the sprinkler cannula 6 can be inserted into the subcutaneous tissue 4, either perpendicularly with respect to the skin surface (see FIG. 6a), or at another angle (see FIG. 6b) e.g., 30 degrees.
- the passageway 213 can be tilted in various angles at patient's discretion.
- FIG. 7 illustrate a device (or system) according to some embodiments which comprises at least 3 units: (i) a dispensing patch 10, a skin adherable cradle 20 and a remote control 900.
- the patch 10 can be disconnected and reconnected from and to the cradle 20.
- the connecting lumen of the patch 10 enables fluid communication between the patch and the subcutaneously insertable sprinkler cannula that is preferably rigidly connected to the cradle. Fluid delivery can be remotely controlled by the remote control or by switches located on the patch 10.
- the patch 10 can employ a pumping mechanism which includes a syringe with a propelling plunger.
- the pumping mechanism can include a peristaltic mechanism having a tube, a magnetic mechanism or any other pumping mechanism known to one skilled in the art.
- the patch can further include a reservoir to retain the therapeutic fluid and an outlet port to enable fluid exit.
- the patch can comprise a single part including a reservoir, one or more batteries, electronics, and driving mechanism (e.g., motor, gear) within a single housing.
- the patch can comprise two-parts:
- RP reusable part
- RP reusable part
- electronics e.g., a processor or controller, a memory, a transceiver, a printed circuit board
- other relatively expensive components e.g., sensors
- a disposable part which can include an outlet port, a reservoir, a slidable plunger, a drive screw, and a nut.
- the DP may contain the one or more batteries which supply power for patch operation.
- the RP can include at least a portion of a pump, and the DP may include another portion of the pump.
- the patch e.g., therapeutic fluid delivery
- the one or more batteries can be located in the RP, in the DP, or shared between the two parts. In some embodiments, the one or more batteries can be rechargeable.
- the reservoir includes a flat profile (e.g., oval, ellipse, four arches) maintaining a relatively thin RP configuration.
- Each one of the RP and DP may include a housing.
- the housing may include a shell or pocket and an "insert" (e.g., configured as a chassis). Accordingly, upon connection of the RP to the DP, the two housings and inserts are coupled.
- the cradle 20 is configured as a flat sheet (preferably rigid) with an adhesive layer facing the skin.
- the cradle is also provided with a passageway to receive a subcutaneously insertable cannula (e.g., sprinkler cannula) and may be provided with snaps, clasps, and/or latches to secure the cannula and patch (for example).
- a subcutaneously insertable cannula e.g., sprinkler cannula
- snaps, clasps, and/or latches to secure the cannula and patch (for example).
- the RC is configured as a handheld device for programming fluid flows, controlling the patch, data acquisition, and for providing indications to the user (e.g., via a display, speaker, vibration mechanism).
- the RC 900 can include a screen 902, a keypad 904, and a blood glucose monitor.
- a test strip 908 can be received within a recess 906 so that glucose concentration can be evaluated and presented on the screen 902.
- fluid delivery can be carried out based on the blood glucose concentration measured by the blood glucose monitor (e.g., in an open loop mode, semi-open loop mode or closed loop mode).
- FIG. 8 illustrates an example of a two-part patch 10 that is comprised at least of a reusable part 100 and a disposable part 200.
- the reusable part 100 includes operating switches/buttons 15 and the disposable part 200 includes a reservoir 220 and an outlet port 216.
- the drive screw 306 can engage with a gear located in the RP to allow linear displacement of a plunger within the reservoir.
- the outlet port 216 includes connecting lumen 215 to enable fluid communication between the reservoir 220 and the sprinkler cannula (when connecting the patch to a cradle).
- FIGs. 9a-c illustrate a spatial view of a cradle 20 before (see FIG. 9a) and after (see FIGs. 9b-c) attachment to a sprinkler cannula 6, according to some embodiments of the disclosure.
- FIG. 9a illustrates cradle 20 which may comprise a protrusion provided with a passageway 213.
- Two snaps/latches 23 and 23' provide connection (preferably rigid) of the sprinkler cannula 6 to the cradle 20 after insertion of the cannula 6 through the passageway 213.
- FIGs. 9b and 9c illustrate the sprinkler cannula 6 connected to cradle 20.
- the sprinkler cannula 6 may comprise a hole/opening at its tip 68 and a plurality of holes 66 along its longitudinal axis.
- FIGs. 10a-b illustrate a cross sectional view of the sprinkler cannula 6 connected to cradle 20 at an angle "A", provided with holes 66 is inserted through the passageway 213.
- FIGs. 1 la-b illustrate a tilted insertion of the sprinkler cannula 6 through the passageway 213 and into the subcutaneous tissue.
- a cannula cartridge 90 includes a sprinkler cannula 6, a penetrating member 92 with a sharp tip and a cap 94, and a cannula hub 69. After insertion ⁇ see FIG. 1 Ib), the cannula hub 69 is preferably rigidly connected to the cradle 20 and the penetrating member 92 (including the cap 90) is retracted.
- FIGs. 12a-b illustrate sprinkler cannula 6 provided with a self sealable seal 65 according to some embodiments.
- the cannula cartridge 90 preferably includes (before insertion) sprinkler cannula 6, a penetrating member 92 with a cap 94, and a cannula hub 69,
- the sprinkler cannula seal 65 seals the cannula tip after retraction of the penetrating member 92.
- the seal 65 can be made of rubber that can be pierced by the penetrating member while being sealed after retraction of the penetrating member.
- the self sealable seal 65 can be used when drug delivery from the cannula tip is unnecessary or should be avoided while maintaining drug delivery through the sprinkler cannula holes 66.
- FIG. 13 illustrate a dispensing patch 10 connected to a cradle 20 according to some embodiments.
- the patch 10 can dispense fluid through the sprinkler cannula 6 into the body of a patient, where the patch 10 includes reusable part 100 and disposable part 200 and can be operated by operating switches/buttons 15.
- FIGs. 14a-b illustrate connection of dispensing patch 10 to skin adherable cradle 20 and skewed/tilted sprinkler cannula 6.
- FIG. 14a illustrates patch 10 which may include reusable part 100 and disposable part 200.
- the reusable part may include switches/buttons 15 (which may be used for operation).
- the disposable part may also include an outlet port 216 which can be configured as a recess in the bottom side of the patch 10 and may include a connecting lumen 215.
- the cradle 20 is preferably adherable to the skin and the sprinkler cannula 6 is inserted within the subcutaneous tissue 4 in an angled position.
- the sprinkler cannula 6 can be placed, at least in part, in the cutaneous tissue.
- FIG. 14b illustrates the two-part patch 10 connected to cradle 20 where connecting lumen 215 pierces the septum of the cannula hub to establish fluid communication between the reservoir, located in the disposable part of the patch, and the sprinkler cannula 6.
- FIG. 15a illustrates a cross sectional view of a dispensing patch 10 comprised of two parts (100, 200) according to some embodiments, which is provided with a conventional cannula 6' known in the art.
- the cannula 6' is provided with a single fluid exit at the cannula tip 68.
- a depot 59 is formed at the cannula tip 68 and subsequently the fluid absorption process begins.
- the absorption process may include diffusion of the drug (e.g., insulin) molecules in accordance with Fick's laws.
- the diffusion rate may be proportional to the effective diffusion area.
- FIG. 15b illustrates the dispensing patch 10 that delivers fluid into the body through sprinkler cannula 6 that is located within the subcutaneous tissue 4.
- the fluid is delivered through the cannula tip 68 and through the plurality of holes 66 located along the longitudinal axis of the cannula 6 forms depot 59 at the cannula tip 68 and a plurality of depots at the holes 66 along the cannula side walls.
- FIG. 15c illustrates sprinkler cannula 6 inserted within the subcutaneous tissue 4 in an angled/tilted direction. The drug depots 59 emerge from the sprinkler cannula holes 66 and from the cannula
- FIG. 16 illustrates sprinkler cannula 6 that includes holes 66 having unidirectional valves.
- the sprinkler cannula 6 is connected to cradle 20, emerging from a cradle opening 214.
- Drug depots 59 can be formed at the cannula side walls and at the cannula tip 68.
- FIGs. 17a-c illustrate skin securable patch 10 that comprises dispensing apparatus 1005 for drug (e.g., insulin) delivery and sensing apparatus 1006 for continuously sensing of analytes (e.g. glucose) within the body.
- drug e.g., insulin
- analytes e.g. glucose
- insulin can be dispensed in correspondence with glucose readings forming a closed loop system.
- FIG. 17a illustrates a cross sectional view of the patch 10 that is comprises at least of a reusable part 100 and a disposable part 200.
- the patch 10 is connected to skin adherable cradle 20.
- the dispensing and sensing apparatuses (1005 and 1006 respectively) may be connected to a tip that is inserted into the subcutaneous tissue 4, where the tip may comprise a sprinkler cannula 6 for insulin dispensing and a sensing element 611 (also referred-to as "sensor") for glucose sensing.
- FIG. 17b and FIG. 17c illustrate normal and magnified spatial views patch and tip.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10758146A EP2414028A4 (en) | 2009-03-30 | 2010-04-06 | Devices and methods for enhancing drug absorption rate |
CN2010800215075A CN102427846A (en) | 2009-03-30 | 2010-04-06 | Devices and methods for enhancing drug absorption rate |
AU2010231527A AU2010231527A1 (en) | 2009-03-30 | 2010-04-06 | Devices and methods for enhancing drug absorption rate |
US13/260,820 US20120265166A1 (en) | 2009-03-30 | 2010-04-06 | Devices and methods for enhancing drug absorption rate |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US16478709P | 2009-03-30 | 2009-03-30 | |
US61/164,787 | 2009-03-30 |
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WO2010113159A1 true WO2010113159A1 (en) | 2010-10-07 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/IL2010/000275 WO2010113159A1 (en) | 2009-03-30 | 2010-04-06 | Devices and methods for enhancing drug absorption rate |
Country Status (5)
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---|---|
US (1) | US20120265166A1 (en) |
EP (1) | EP2414028A4 (en) |
CN (1) | CN102427846A (en) |
AU (1) | AU2010231527A1 (en) |
WO (1) | WO2010113159A1 (en) |
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WO2016115464A1 (en) * | 2015-01-15 | 2016-07-21 | Deka Products Limited Partnership | Infusion device system and apparatus |
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US11109800B2 (en) * | 2019-01-04 | 2021-09-07 | Enable Injections, Inc. | Medical fluid injection apparatus and method with detachable patch and monitoring |
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Also Published As
Publication number | Publication date |
---|---|
EP2414028A1 (en) | 2012-02-08 |
AU2010231527A1 (en) | 2011-11-03 |
EP2414028A4 (en) | 2012-09-19 |
US20120265166A1 (en) | 2012-10-18 |
CN102427846A (en) | 2012-04-25 |
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