US20090308895A1 - Rack and pinon drive for by-pass cartridge - Google Patents

Rack and pinon drive for by-pass cartridge Download PDF

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Publication number
US20090308895A1
US20090308895A1 US12/157,866 US15786608A US2009308895A1 US 20090308895 A1 US20090308895 A1 US 20090308895A1 US 15786608 A US15786608 A US 15786608A US 2009308895 A1 US2009308895 A1 US 2009308895A1
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US
United States
Prior art keywords
cartridge
closure member
piston
chamber
plunger rod
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US12/157,866
Inventor
David L. Reynolds
Daniel MacDonald
Roger McCarthy
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DOUJECT MEDICAL SYSTEMS Inc
Original Assignee
DOUJECT MEDICAL SYSTEMS Inc
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 DOUJECT MEDICAL SYSTEMS Inc filed Critical DOUJECT MEDICAL SYSTEMS Inc
Priority to US12/157,866 priority Critical patent/US20090308895A1/en
Assigned to DOUJECT MEDICAL SYSTEMS INC. reassignment DOUJECT MEDICAL SYSTEMS INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MACDONALD, DANIEL, MCCARTHY, ROGER, REYNOLDS, DAVID L.
Priority to JP2011512794A priority patent/JP2011523873A/en
Priority to EP09761205.5A priority patent/EP2296797B1/en
Priority to US12/737,013 priority patent/US8123084B2/en
Priority to AU2009257142A priority patent/AU2009257142B2/en
Priority to CA2725620A priority patent/CA2725620C/en
Priority to PCT/CA2009/000806 priority patent/WO2009149547A1/en
Publication of US20090308895A1 publication Critical patent/US20090308895A1/en
Priority to IL209941A priority patent/IL209941A/en
Priority to JP2014139028A priority patent/JP2014223397A/en
Priority to JP2016124716A priority patent/JP6306096B2/en
Abandoned legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/7174—Feed mechanisms characterised by the means for feeding the components to the mixer using pistons, plungers or syringes
    • 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • B01F33/50112—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held of the syringe or cartridge type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/50—Mixing receptacles
    • B01F35/52—Receptacles with two or more compartments
    • B01F35/522—Receptacles with two or more compartments comprising compartments keeping the materials to be mixed separated until the mixing is initiated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/712—Feed mechanisms for feeding fluids
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/3152—Piston or piston-rod constructions, e.g. connection of piston with piston-rod including gearings to multiply or attenuate the piston displacing force

Definitions

  • the present invention relates to a by-pass cartridge and in particular to a device and method for storing, mixing and delivering pharmaceuticals.
  • dual chambered syringes which use a by-pass channel to provide fluid communication between the two chambers.
  • the two chambers are commonly defined within a syringe barrel by two separate pistons and an end stopper spaced apart within the syringe barrel.
  • the two chambers are placed in fluid communication by the by-pass channel by actuation of the outer most piston within the syringe barrel. This causes both pistons within the syringe barrel to advance to a point where the inner most piston becomes aligned with the by-pass channel. At that point, further actuation of the outer most piston causes fluid contained in the chamber between the two pistons to flow into the outwardly extending by-pass channel and around the inner most piston which remains stationary.
  • a device for mixing a substance comprised of two constituents comprising a cartridge, a cartridge holder, a tubular container having a fluid communication end and an actuation end, the fluid communication end being receivable in the cartridge holder, the tubular container having a first closure member disposed at the fluid communication end, a second closure member disposed at the actuation end, a piston within the container intermediate the first and second closure members, and a by-pass channel for enabling fluid to by-pass the piston when the piston is in the by-pass position, a plunger rod engageable with the second closure member for moving the second closure member within the container, the plunger rod having a rack gear formed thereon, a housing, a pinon gear mounted within the housing, the pinon gear being engageable with the rack gear, and a handle connected to the pinion gear.
  • the transfer device of the present invention may be utilized with any suitable by-pass type cartridge or container. Many such by-pass cartridges or containers are known in the art.
  • the second closure member is screw threadedly connectable to the plunger rod.
  • Utilizing the transfer device of the present invention significantly reduces the possibility of the piston moving past the by-pass channel prior to transfer of the diluent to the chamber containing the active ingredient. In other words, it becomes difficult to rapidly move the second closure at the actuation end.
  • FIG. 1 is a partially exploded perspective view of a device according to the present invention
  • FIG. 2 is a side elevational view of the device
  • FIGS. 3A , 3 B and 3 C are side sectional view illustrating operation of the device
  • FIG. 4 illustrates the detachment of the cartridge holder from the housing
  • FIG. 5 illustrates a pen injector utilizing the cartridge of the present invention.
  • Cartridge 12 is of a substantially conventional structure and includes an activation end 16 and a fluid communication end 14 .
  • a first closure member 18 seals fluid communication end 14 while a second closure member 20 seals activation end 16 .
  • first chamber 26 Situated interiorly of the cartridge 12 and intermediate closure members 18 and 20 is a plunger 22 which divides the cartridge into a first chamber 26 and a second chamber 28 .
  • a by-pass 24 provides fluid communication between first chamber 26 and second chamber 28 .
  • first chamber 26 will carry the dry pharmaceutical component to be reconstituted while second chamber 28 normally will carry a liquid diluent.
  • second chamber 28 normally will carry a liquid diluent.
  • other arrangements such as two liquids can be utilized.
  • cartridge 12 At it upper end (fluid communication end) cartridge 12 has a shoulder 30 .
  • Cartridge holder 32 surrounds cartridge 12 and has screw threads 31 at its lower end. A shoulder 36 of cartridge holder 32 abuts shoulder 30 of cartridge 12 .
  • a cap 38 having screw threads thereon is arranged to fit on fluid communication end 14 of cartridge 12 .
  • Cap 38 includes a piercing member 40 which has a passageway 43 therein.
  • a gas permeable hydrophobic membrane 41 is secured to the top of cap 38 and covers passageway 43 .
  • Assembly 10 includes a pair of half housings 42 and 44 which are secured together. At their upper ends, housings 42 and 44 have external threads 45 designed to engage with threads on the inner bottom wall of cartridge holder 32 .
  • a plunger rod 46 Interiorly of housing 42 , 44 is a plunger rod 46 which has a rack gear 48 formed on one side thereof.
  • Rack gear 48 is designed to engage with a pinon gear 50 .
  • a gear retainer 52 is formed on one side of housing 44 while a wheel 54 is arranged to drive pinon gear 50 .
  • housing 42 , 44 is screw threadedly engaged with cartridge holder 32 .
  • plunger rod 46 abuts closure member 20 .
  • Operation of wheel 54 will cause movement of plunger rod 46 which will then advance closure member 20 which in turn causes pressure to advance plunger 22 to the position shown in FIG. 3B wherein it is located at by-pass 24 .
  • Continued slow and steady advancement will then cause the diluent in second chamber 28 to enter first chamber 26 until closure member 20 abuts plunger 22 .
  • the two components in chambers 26 and 28 are then mixed; any air present is evacuated through passageway 43 in piercing member 40 while the liquid is retained due to hydrophobic membrane 41 .
  • cartridge holder 32 When fully mixed, cartridge holder 32 can be unscrewed from housing 42 , 44 and is then attached to a pen injector 56 in a conventional manner as shown in FIGS. 4 and 5 .

Abstract

A device for mixing a substance comprised of two constituents contained in a cartridge and having a cartridge holder thereabout, the device comprising a plunger rod for pushing the closure member to permit the transfer of a diluent in a first chamber through a by-pass channel to mix with a constituent in a first chamber, the plunger rod being driven by means of a rack and a pinion gear arrangement to prevent overly rapid movement of the plunger rod.

Description

    FIELD OF THE INVENTION
  • The present invention relates to a by-pass cartridge and in particular to a device and method for storing, mixing and delivering pharmaceuticals.
    • BACKGROUND OF THE INVENTION
  • In pharmaceutical delivery systems, it is sometimes necessary to mix a drug in powder form with a diluent in order to be able to deliver the drug to a subject. This can be done manually by injecting the diluent into a vial containing the powdered drug, mixing the drug into the diluent and aspirating the drug in fluid form into a syringe for subsequent injection into the subject. Such manual procedures are generally considered to be cumbersome and inconvenient and often lead to wastage of some of the drug as it may remain in the vial.
  • Also known in the art are dual chambered syringes which use a by-pass channel to provide fluid communication between the two chambers. The two chambers are commonly defined within a syringe barrel by two separate pistons and an end stopper spaced apart within the syringe barrel. In such an arrangement, the two chambers are placed in fluid communication by the by-pass channel by actuation of the outer most piston within the syringe barrel. This causes both pistons within the syringe barrel to advance to a point where the inner most piston becomes aligned with the by-pass channel. At that point, further actuation of the outer most piston causes fluid contained in the chamber between the two pistons to flow into the outwardly extending by-pass channel and around the inner most piston which remains stationary.
  • With the two chamber syringe barrel and external by-pass arrangement described above, a danger exists in the possibility that the inner most piston is pushed too far along such that it goes past the by-pass channel before full transfer of the diluent occurs. This may be caused by an overly vigorous application of the plunger to the outer most piston. Once the inner most piston is pushed past the by-pass channel without having allowed proper fluid flow from the first chamber to the second chamber, it can be extremely difficult to correct.
  • With some pharmaceutical constituents, in order to properly constitute the pharmaceutical substance, it is desirable to ensure that the mixing of the two constituents occurs slowly and evenly.
    • SUMMARY OF THE INVENTION
  • It is an object of the present invention to provide a method and a device which allows the mixing of two constituents of a pharmaceutical substance and which overcomes the above drawbacks in prior art devices.
  • According to one aspect of the present invention, there is provided a device for mixing a substance comprised of two constituents, the device comprising a cartridge, a cartridge holder, a tubular container having a fluid communication end and an actuation end, the fluid communication end being receivable in the cartridge holder, the tubular container having a first closure member disposed at the fluid communication end, a second closure member disposed at the actuation end, a piston within the container intermediate the first and second closure members, and a by-pass channel for enabling fluid to by-pass the piston when the piston is in the by-pass position, a plunger rod engageable with the second closure member for moving the second closure member within the container, the plunger rod having a rack gear formed thereon, a housing, a pinon gear mounted within the housing, the pinon gear being engageable with the rack gear, and a handle connected to the pinion gear.
  • The transfer device of the present invention may be utilized with any suitable by-pass type cartridge or container. Many such by-pass cartridges or containers are known in the art. Conventionally, the second closure member is screw threadedly connectable to the plunger rod.
  • Utilizing the transfer device of the present invention significantly reduces the possibility of the piston moving past the by-pass channel prior to transfer of the diluent to the chamber containing the active ingredient. In other words, it becomes difficult to rapidly move the second closure at the actuation end.
    • BRIEF DESCRIPTION OF THE DRAWINGS
  • Having thus generally described the invention, reference will be made to the drawings illustrating an embodiment thereof, in which:
  • FIG. 1 is a partially exploded perspective view of a device according to the present invention;
  • FIG. 2 is a side elevational view of the device;
  • FIGS. 3A, 3B and 3C are side sectional view illustrating operation of the device;
  • FIG. 4 illustrates the detachment of the cartridge holder from the housing; and
  • FIG. 5 illustrates a pen injector utilizing the cartridge of the present invention.
    •  DETAILED DESCRIPTION OF THE INVENTION
  • Referring to the drawings in greater detail and by reference characters thereto, there is illustrated an assembly generally designated by reference numeral 10 and which assembly 10 includes a cartridge 12. Cartridge 12 is of a substantially conventional structure and includes an activation end 16 and a fluid communication end 14. A first closure member 18 seals fluid communication end 14 while a second closure member 20 seals activation end 16.
  • Situated interiorly of the cartridge 12 and intermediate closure members 18 and 20 is a plunger 22 which divides the cartridge into a first chamber 26 and a second chamber 28. As is known in the art, a by-pass 24 provides fluid communication between first chamber 26 and second chamber 28. Normally, first chamber 26 will carry the dry pharmaceutical component to be reconstituted while second chamber 28 normally will carry a liquid diluent. Naturally, other arrangements such as two liquids can be utilized.
  • At it upper end (fluid communication end) cartridge 12 has a shoulder 30.
  • Cartridge holder 32 surrounds cartridge 12 and has screw threads 31 at its lower end. A shoulder 36 of cartridge holder 32 abuts shoulder 30 of cartridge 12.
  • A cap 38 having screw threads thereon is arranged to fit on fluid communication end 14 of cartridge 12. Cap 38 includes a piercing member 40 which has a passageway 43 therein. A gas permeable hydrophobic membrane 41 is secured to the top of cap 38 and covers passageway 43.
  • Assembly 10 includes a pair of half housings 42 and 44 which are secured together. At their upper ends, housings 42 and 44 have external threads 45 designed to engage with threads on the inner bottom wall of cartridge holder 32.
  • Interiorly of housing 42, 44 is a plunger rod 46 which has a rack gear 48 formed on one side thereof. Rack gear 48 is designed to engage with a pinon gear 50. A gear retainer 52 is formed on one side of housing 44 while a wheel 54 is arranged to drive pinon gear 50.
  • In operation, and as may be seen in FIGS. 3A to 3C, housing 42, 44 is screw threadedly engaged with cartridge holder 32. At this point in time, plunger rod 46 abuts closure member 20. Operation of wheel 54 will cause movement of plunger rod 46 which will then advance closure member 20 which in turn causes pressure to advance plunger 22 to the position shown in FIG. 3B wherein it is located at by-pass 24. Continued slow and steady advancement will then cause the diluent in second chamber 28 to enter first chamber 26 until closure member 20 abuts plunger 22. The two components in chambers 26 and 28 are then mixed; any air present is evacuated through passageway 43 in piercing member 40 while the liquid is retained due to hydrophobic membrane 41.
  • When fully mixed, cartridge holder 32 can be unscrewed from housing 42, 44 and is then attached to a pen injector 56 in a conventional manner as shown in FIGS. 4 and 5.
  • It will be understood that the above described embodiments are for purposes of illustration only and that changes and modifications may be made thereto without departing from the spirit and scope of the invention.

Claims (7)

1. A device for mixing a substance comprised of two constituents, the device comprising:
a cartridge;
a cartridge holder;
said cartridge having a fluid communication end and an actuation end, said fluid communication end being receivable in said cartridge holder, the tubular container having a first closure member disposed at the fluid communication end, a second closure member disposed at the actuation end, a piston within the container intermediate the first and second closure members, and a by-pass channel for enabling fluid to by-pass the piston when the piston is in the by-pass position;
a plunger rod engageable with the second closure member for moving the second closure member within the cartridge, said plunger rod having a rack gear formed thereon;
a housing, a pinon gear mounted within said housing, said pinon gear being engageable with said rack gear, and a handle connected to said pinion gear.
2. The device of claim 1 further including a cap at a distal end of said cartridge, said cap having a piercing member with a fluid passageway therein, and a hydrophobic membrane associated with said passageway to permit the egress of gas therethrough while preventing the passage of liquid.
3. The device of claim 1 wherein said handle comprises a thumb wheel, the arrangement being such that a turning of said thumb wheel drives said pinon gear which in turn drives said rack gear to advance said plunger rod.
4. The device of claim 3 wherein said housing is screw threadedly engaged with said cartridge holder.
5. The device of claim 2 wherein a first chamber is defined between said first closure member and said piston and a second chamber is defined between said second closure member and said piston, said first chamber containing a dry constituent and said second chamber containing a diluent therefore.
6. The device of claim 1 wherein said hydrophobic membrane is secured to a top of said cap, said hydrophobic membrane extending over said passageway.
7. The device of claim 2 wherein said cap is screw threadedly engaged with said cartridge holder.
US12/157,866 2008-06-13 2008-06-13 Rack and pinon drive for by-pass cartridge Abandoned US20090308895A1 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
US12/157,866 US20090308895A1 (en) 2008-06-13 2008-06-13 Rack and pinon drive for by-pass cartridge
PCT/CA2009/000806 WO2009149547A1 (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge
AU2009257142A AU2009257142B2 (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge
EP09761205.5A EP2296797B1 (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge
US12/737,013 US8123084B2 (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge
JP2011512794A JP2011523873A (en) 2008-06-13 2009-06-10 Rack and pinion drive for bypass cartridge
CA2725620A CA2725620C (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge
IL209941A IL209941A (en) 2008-06-13 2010-12-12 Rack and pinion drive for by-pass cartridge
JP2014139028A JP2014223397A (en) 2008-06-13 2014-07-04 Rack and pinion driver for bypass cartridge
JP2016124716A JP6306096B2 (en) 2008-06-13 2016-06-23 Rack and pinion drive for bypass cartridge

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US12/157,866 US20090308895A1 (en) 2008-06-13 2008-06-13 Rack and pinon drive for by-pass cartridge

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/737,013 Continuation US8123084B2 (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge

Publications (1)

Publication Number Publication Date
US20090308895A1 true US20090308895A1 (en) 2009-12-17

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ID=41413831

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Application Number Title Priority Date Filing Date
US12/157,866 Abandoned US20090308895A1 (en) 2008-06-13 2008-06-13 Rack and pinon drive for by-pass cartridge
US12/737,013 Active US8123084B2 (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge

Family Applications After (1)

Application Number Title Priority Date Filing Date
US12/737,013 Active US8123084B2 (en) 2008-06-13 2009-06-10 Rack and pinion drive for by-pass cartridge

Country Status (7)

Country Link
US (2) US20090308895A1 (en)
EP (1) EP2296797B1 (en)
JP (3) JP2011523873A (en)
AU (1) AU2009257142B2 (en)
CA (1) CA2725620C (en)
IL (1) IL209941A (en)
WO (1) WO2009149547A1 (en)

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CA2725620A1 (en) 2009-12-17
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JP2016195781A (en) 2016-11-24
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US8123084B2 (en) 2012-02-28
CA2725620C (en) 2015-01-13
US20110068124A1 (en) 2011-03-24
EP2296797A4 (en) 2013-04-17
IL209941A0 (en) 2011-02-28
JP2014223397A (en) 2014-12-04
EP2296797B1 (en) 2014-09-17
JP6306096B2 (en) 2018-04-04
WO2009149547A1 (en) 2009-12-17
AU2009257142A1 (en) 2009-12-17
AU2009257142B2 (en) 2014-07-03

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