WO2011060541A1 - Dispositif d'injection à double poussée - Google Patents

Dispositif d'injection à double poussée Download PDF

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Publication number
WO2011060541A1
WO2011060541A1 PCT/CA2010/001837 CA2010001837W WO2011060541A1 WO 2011060541 A1 WO2011060541 A1 WO 2011060541A1 CA 2010001837 W CA2010001837 W CA 2010001837W WO 2011060541 A1 WO2011060541 A1 WO 2011060541A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
plunger rod
needle
housing
reconstitution
Prior art date
Application number
PCT/CA2010/001837
Other languages
English (en)
Inventor
David L. Reynolds
Daniel Macdonald
Yan Tremblay
Julie Trepanier
Steven Raymond
Original Assignee
Duoject 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 Duoject Medical Systems Inc. filed Critical Duoject Medical Systems Inc.
Publication of WO2011060541A1 publication Critical patent/WO2011060541A1/fr

Links

Classifications

    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • 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
    • 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
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • 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

Definitions

  • the present invention relates to a medical device and more particularly, relates to a reconstitution and injection system.
  • drugs are desirably stored as two separate components.
  • the components are typically a dry component and a diluent therefore, although two liquid components could also be utilized.
  • the advantages of storing one of the components in a dry form is that a greater shelf life is provided.
  • the drug and a diluent are mixed immediately prior to injection.
  • a syringe is filled manually by aspirating a liquid pharmaceutical component from a pharmaceutical vial having a neck with a penetrable closure into the syringe through a needle that penetrates the penetrable closure.
  • the method of manually filling the syringe typically includes the steps of drawing air into the body of the syringe by pulling the syringe's plunger away from the needle end of the syringe until the volume of air in the body approximately equals the volume of pharmaceutical component to be loaded into the syringe, carefully aligning the needle with the vial's penetrable closure and inserting the needle through the penetrable closure into the vial, inverting the vial and forcing from the body of the syringe into the vial by advancing the syringe's plunger, withdrawing the plunger to draw out the desired volume of the pharmaceutical component into the syringe, and removing the needle from the vial.
  • the solid component is reconstituted by providing a first solid component package in a pharmaceutical vial which has a neck closed by a penetrable closure. Subsequently, the second liquid component is provided in a syringe wherein the second liquid component (diluent) is injected into the vial through the penetrable closure.
  • a swirling or shaking motion is then used to dissolve, dilute or suspend the first solid component in the diluent and then the mixture is aspirated back into the syringe.
  • the two or more components could also be a liquid and require mixing just prior to administration.
  • a reconstitution and injection system comprising a housing having a front end and a rear end, a distal cartridge containing a first substance, the distal cartridge being located within the housing, the distal cartridge having a first cartridge plunger and a first cartridge septum, a proximal cartridge containing a second substance, the proximal cartridge being located within the housing rearwardly of the distal cartridge, the proximal cartridge having a second cartridge plunger and a second cartridge septum, a first needle hub intermediate the distal and proximal cartridges, a first needle being mounted within the first needle hub, the first needle having first and second piercing ends, a second needle hub located forwardly of the distal cartridge, a second needle mounted in the second needle hub, the second needle having first and second piercing ends, a first biasing member mounted within the housing, the first biasing member being located forwardly of the distal cartridge and being operative to bias the distal cartridge rearwardly, and a plunger
  • the plunger rod assembly will include an inner plunger rod and an outer plunger rod.
  • the inner plunger rod and outer plunger rod are telescopically constructed with a biasing spring acting to bias the inner plunger rod outwardly of the outer plunger rod. Provision may also be made for locking the inner plunger rod and outer plunger rod together when the inner plunger rod extends outwardly.
  • Figure 1 A is a side elevational view of a reconstitution and injection system according to an embodiment of the present invention:
  • Figure IB is a longitudinal cross sectional view of the reconstitution and injection system of Figure 1;
  • Figure 1C and ICC are longitudinal cross sectional views similar to Figure IB illustrating the commencement of piercing of a cartridge
  • Figure ID and 1DD are longitudinal cross sectional views illustrating the piercing of the other of the cartridges
  • Figure IE is a longitudinal cross sectional view illustrating the transfer of diluent to the powder drug
  • Figure IF is a longitudinal cross sectional view illustrating the retraction of the inner plunger rod
  • Figure 1G illustrates the injection of the combined diluent and drug
  • Figure 1H is a longitudinal cross sectional view illustrating the retraction of the needle after injection.
  • Figure II is a longitudinal cross sectional view of the reconstitution and injection system at the end of the process.
  • Reconstitution injection system 10 includes a housing side wall 12 which is generally of a cylindrical configuration along with a front end wall 14 and a rear end wall 16.
  • distal means the end used for injection while proximal means the opposite end or the end where a pushing force is applied.
  • Front end wall 14 has a nose 18 formed thereon through which a passageway extends. It will be noted that there is also provided an enlarged portion 20 of housing wall 12 proximate front wall 14. Enlarged portion 20 forms an abutment wall 22.
  • a window 15 provides visual access to the interior.
  • proximal container or cartridge 24 which is of a generally cylindrical configuration and includes a neck portion 26.
  • Proximal container 24 also has a plunger 28 located at the proximal end thereof and a septum 30 covering the container opening.
  • a diluent 35 is contained in cartridge 24.
  • a distal container or cartridge 32 is situated forwardly of proximal cartridge 24 and also has a septum 34 and a plunger 36. It will be noted that the side wall defining distal container 32 extends substantially past plunger 36 such that proximal cartridge 24 is partially located within the wall of distal cartridge 32.
  • first needle hub 38 Mounted intermediate of proximal cartridge 24 and distal cartridge 32 is a first needle hub 38 which includes a first needle 40 mounted therein.
  • First needle 40 has a first piercing end 42 and a second piercing end 44.
  • Second needle 48 has a first piercing end 50 and a second or injection end 52.
  • Second needle hub 46 also includes a wall 47 which extends about the wall defining distal cartridge 32 and partially about proximal cartridge 24.
  • a spring 54 is mounted within housing wall 12 forwardly of second needle hub 46 and is biased against second needle hub 46 and front end wall 14.
  • the reconstitution and injection system 10 also includes an outer plunger rod 58 which is screwthreadedly engaged with plunger 28 and an inner plunger rod 60 which is mounted inwardly of outer plunger rod 58 and releasably retained therein.
  • a spring 62 is mounted interiorly of outer plunger rod 58 and biases against inner plunger rod 60.
  • plunger rods 58, 60 As shown in Figures 1C, ICC, ID and 1DD, pressure on plunger rods 58, 60 as shown by arrow 64 will cause the movement of plunger 28 such that first needle 40 will pierce plunger 36 of distal container 32 and septum 30 of proximal cartridge 24. This will cause the diluent 35 within proximal cartridge 24 to transfer to distal cartridge 32. If desired, the device may be shaken to ensure proper reconstitution to form mixture 55.
  • inner plunger rod 60 may be released from its inner engagement with outer plunger rod 58.
  • Spring 62 will then bias inner plunger rod 60 outwardly of outer plunger rod 58 as illustrated by arrow 66 in Figure IF.
  • inner plunger rod 60 has protrusions 68 which will lock with corresponding recesses formed in outer plunger rod 58.
  • the device is now ready for injection as shown in Figure 1G.
  • the reconstitution and injection system provides an arrangement wherein the drug and the diluent can be mixed immediately prior to injection and injected from the same assembly.
  • the spring forces the retraction of the needle so that it is safely contained within the assembly following injection.

Abstract

L'invention porte sur un dispositif de reconstitution et d'injection, qui comprend un boîtier (12) comportant une extrémité avant (14) et une extrémité arrière (16), une cartouche distale (32) contenant une première substance (35), la cartouche comportant un premier plongeur de cartouche (34) et un premier diaphragme de cartouche (36), une cartouche proximale (24) contenant une deuxième substance (45) qui est disposée à l'intérieur du boîtier (12) en arrière de la première cartouche (34), la cartouche proximale (24) comportant un plongeur (28) et un diaphragme (30), une première garde d'aiguille (38) intermédiaire entre les première et deuxième cartouches, avec une première aiguille (40) qui est montée dans celle-ci, une deuxième garde d'aiguille (46) disposée en avant de la cartouche distale (32) et comportant une aiguille (48) montée dans celle-ci, un premier élément de sollicitation (54) monté à l'intérieur du boîtier (12), et disposé en avant de la cartouche proximale (24), et agissant de façon à solliciter la cartouche vers l'arrière, et un ensemble de tige de plongeur (58, 60) pouvant être fixé au deuxième plongeur de cartouche.
PCT/CA2010/001837 2009-11-20 2010-11-19 Dispositif d'injection à double poussée WO2011060541A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CA 2686433 CA2686433A1 (fr) 2009-11-20 2009-11-20 Dispositif d'injection a double poussee
CA2,686,433 2009-11-20

Publications (1)

Publication Number Publication Date
WO2011060541A1 true WO2011060541A1 (fr) 2011-05-26

Family

ID=44059156

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2010/001837 WO2011060541A1 (fr) 2009-11-20 2010-11-19 Dispositif d'injection à double poussée

Country Status (2)

Country Link
CA (1) CA2686433A1 (fr)
WO (1) WO2011060541A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012167353A1 (fr) * 2011-06-10 2012-12-13 Duoject Medical Systems Inc. Dispositif d'injection
WO2014085118A1 (fr) * 2012-11-30 2014-06-05 Unitract Syringe Pty Ltd Dispositif à combinaison de pistons de seringue de mélange à deux chambres
CN104159626A (zh) * 2012-03-08 2014-11-19 贝克顿·迪金森公司 药物重构系统
US20140358091A1 (en) * 2013-06-04 2014-12-04 Unitract Syringe Pty Ltd Actuation mechanisms for dual chamber mixing syringes
JP2014533600A (ja) * 2011-12-01 2014-12-15 ノボ・ノルデイスク・エー／エス 充填薬剤送出アセンブリ
US9205194B2 (en) 2011-08-05 2015-12-08 Unitract Syringe Pty Ltd Dual chamber mixing device for a syringe
WO2016028820A3 (fr) * 2014-08-18 2016-04-14 Windgap Medical, Inc Dispositif portable de mélange et d'administration de médicament et procédés associés
WO2017027876A1 (fr) * 2015-08-13 2017-02-16 Windgap Medical, Inc Dispositif de mélange et d'injection à éléments de stérilité
US9821118B2 (en) 2011-09-02 2017-11-21 Unl Holdings Llc Automatic reconstitution for dual chamber syringe
US9907910B2 (en) 2013-03-15 2018-03-06 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US10195361B2 (en) 2013-03-15 2019-02-05 Windgap Medical, Inc. Portable drug mixing and delivery system and method
US10350364B2 (en) 2009-11-11 2019-07-16 Windgap Medical, Inc. Portable Drug Mixing and Delivery Device and Associated Methods
US10391262B2 (en) 2014-03-18 2019-08-27 Windgap Medical, Inc. Removable actuating cap for use with an auto-injector assembly
US10569017B2 (en) 2013-03-15 2020-02-25 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US11116903B2 (en) 2014-08-18 2021-09-14 Windgap Medical, Inc Compression seal for use with a liquid component storage vial of an auto-injector

Citations (2)

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US5281198A (en) * 1992-05-04 1994-01-25 Habley Medical Technology Corporation Pharmaceutical component-mixing delivery assembly
GB2447787A (en) * 2007-03-21 2008-09-24 Medical House Plc An autoinjector that mixes wet and dry medicament components when moved relative to its packaging

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5281198A (en) * 1992-05-04 1994-01-25 Habley Medical Technology Corporation Pharmaceutical component-mixing delivery assembly
GB2447787A (en) * 2007-03-21 2008-09-24 Medical House Plc An autoinjector that mixes wet and dry medicament components when moved relative to its packaging

Cited By (41)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350364B2 (en) 2009-11-11 2019-07-16 Windgap Medical, Inc. Portable Drug Mixing and Delivery Device and Associated Methods
US9662457B2 (en) * 2011-06-10 2017-05-30 Duoject Medical Systems Inc. Injection device
CN103596610A (zh) * 2011-06-10 2014-02-19 杜杰克特医疗系统有限公司 注射装置
JP2014519384A (ja) * 2011-06-10 2014-08-14 デュオジェクト・メディカル・システムズ・インコーポレイテッド 注射装置
WO2012167353A1 (fr) * 2011-06-10 2012-12-13 Duoject Medical Systems Inc. Dispositif d'injection
EP2717946A4 (fr) * 2011-06-10 2015-06-17 Duoject Inc Dispositif d'injection
US20150238706A1 (en) * 2011-06-10 2015-08-27 Duo-Ject Medical Systems Inc. Injection device
US10279121B2 (en) 2011-08-05 2019-05-07 Unl Holdings Llc Dual chamber mixing device for a syringe
US9205194B2 (en) 2011-08-05 2015-12-08 Unitract Syringe Pty Ltd Dual chamber mixing device for a syringe
US9821118B2 (en) 2011-09-02 2017-11-21 Unl Holdings Llc Automatic reconstitution for dual chamber syringe
JP2014533600A (ja) * 2011-12-01 2014-12-15 ノボ・ノルデイスク・エー／エス 充填薬剤送出アセンブリ
CN104159626A (zh) * 2012-03-08 2014-11-19 贝克顿·迪金森公司 药物重构系统
US11191902B2 (en) 2012-11-30 2021-12-07 Unl Holdings Llc Combination plunger device for a dual chamber mixing syringe
WO2014085118A1 (fr) * 2012-11-30 2014-06-05 Unitract Syringe Pty Ltd Dispositif à combinaison de pistons de seringue de mélange à deux chambres
US10130768B2 (en) 2012-11-30 2018-11-20 Unl Holdings Llc Combination plunger device for a dual chamber mixing syringe
AU2013353059B2 (en) * 2012-11-30 2018-07-05 Unitract Syringe Pty Ltd Combination plunger device for a dual chamber mixing syringe
JP2015536204A (ja) * 2012-11-30 2015-12-21 ユニトラクト シリンジ プロプライエタリイ リミテッドＵｎｉｔｒａｃｔ Ｓｙｒｉｎｇｅ Ｐｔｙ Ｌｔｄ デュアルチャンバ混合シリンジ用複合プランジャ装置
US9907910B2 (en) 2013-03-15 2018-03-06 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US10569017B2 (en) 2013-03-15 2020-02-25 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US10195361B2 (en) 2013-03-15 2019-02-05 Windgap Medical, Inc. Portable drug mixing and delivery system and method
US10220148B2 (en) 2013-06-04 2019-03-05 Unl Holdings Llc Actuation mechanisms for dual chamber mixing syringes
US20140358091A1 (en) * 2013-06-04 2014-12-04 Unitract Syringe Pty Ltd Actuation mechanisms for dual chamber mixing syringes
US11071825B2 (en) 2013-06-04 2021-07-27 Unl Holdings Llc Actuation mechanisms for dual chamber mixing syringes
US9539393B2 (en) 2013-06-04 2017-01-10 Unitract Syringe Pty Ltd Actuation mechanisms for dual chamber mixing syringes
JP2016520400A (ja) * 2013-06-04 2016-07-14 ユニトラクト シリンジ プロプライエタリイ リミテッドＵｎｉｔｒａｃｔ Ｓｙｒｉｎｇｅ Ｐｔｙ Ｌｔｄ デュアルチャンバ混合シリンジ用アクチュエーション機構
CN105517603A (zh) * 2013-06-04 2016-04-20 尤尼特拉克特注射器公司 用于双腔室混合注射器的致动机构
US10391262B2 (en) 2014-03-18 2019-08-27 Windgap Medical, Inc. Removable actuating cap for use with an auto-injector assembly
US9907911B2 (en) 2014-08-18 2018-03-06 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
CN106794305A (zh) * 2014-08-18 2017-05-31 温德加普医疗股份有限公司 便携式药物混合和递送装置及相关方法
US10300198B2 (en) 2014-08-18 2019-05-28 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US10300199B2 (en) 2014-08-18 2019-05-28 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US9950115B2 (en) 2014-08-18 2018-04-24 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US9925335B2 (en) 2014-08-18 2018-03-27 Windgap Medical, Inc Portable drug mixing and delivery device and associated methods
US10537680B2 (en) 2014-08-18 2020-01-21 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
WO2016028820A3 (fr) * 2014-08-18 2016-04-14 Windgap Medical, Inc Dispositif portable de mélange et d'administration de médicament et procédés associés
US11007320B2 (en) 2014-08-18 2021-05-18 Windgap Medical, Inc. Portable drug mixing and delivery device and associated methods
US11116903B2 (en) 2014-08-18 2021-09-14 Windgap Medical, Inc Compression seal for use with a liquid component storage vial of an auto-injector
WO2017027876A1 (fr) * 2015-08-13 2017-02-16 Windgap Medical, Inc Dispositif de mélange et d'injection à éléments de stérilité
AU2016306797B2 (en) * 2015-08-13 2021-05-20 Windgap Medical, Inc Mixing and injection device with sterility features
US11154658B2 (en) * 2015-08-13 2021-10-26 Windgap Medical, Inc Mixing and injection device with sterility features
US10220147B2 (en) 2015-08-13 2019-03-05 Windgap Medical, Inc. Mixing and injection device with sterility features

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