WO2004032997A2 - Adaptateur de remplissage pour injecteur sans aiguille - Google Patents

Adaptateur de remplissage pour injecteur sans aiguille Download PDF

Info

Publication number
WO2004032997A2
WO2004032997A2 PCT/US2003/032410 US0332410W WO2004032997A2 WO 2004032997 A2 WO2004032997 A2 WO 2004032997A2 US 0332410 W US0332410 W US 0332410W WO 2004032997 A2 WO2004032997 A2 WO 2004032997A2
Authority
WO
WIPO (PCT)
Prior art keywords
adapter
fluid
channel
injection device
barrier
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.)
Ceased
Application number
PCT/US2003/032410
Other languages
English (en)
Other versions
WO2004032997A9 (fr
WO2004032997A3 (fr
Inventor
Paul R. Lesch, Jr.
Kenneth Adam
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.)
Antares Pharma Inc
Original Assignee
Antares Pharma 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 Antares Pharma Inc filed Critical Antares Pharma Inc
Priority to AU2003287060A priority Critical patent/AU2003287060A1/en
Publication of WO2004032997A2 publication Critical patent/WO2004032997A2/fr
Publication of WO2004032997A3 publication Critical patent/WO2004032997A3/fr
Publication of WO2004032997A9 publication Critical patent/WO2004032997A9/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • 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
    • A61M5/1782—Devices aiding filling of syringes in situ

Definitions

  • the present invention is directed to a device for delivery of medicament, and to a device to enable an injection device to be easily filled by the user.
  • Certain drugs are not available in a stable liquid form. For this reason, these drugs may be freeze dried, spray dried or otherwise lyophilized into powder form.
  • the user For administration, the user must reconstitute the drug by adding a diluent to form a solution or suspension of the powder.
  • the injection device When the reconstituted drug is to be administered by injection, the injection device must be filled with the reconstituted drug immediately prior to performing the injection, since the drug will not remain in stable liquid form for long periods of time. Thus, there is a need for an injection device that may be filled by the user immediately prior to inj ection.
  • the invention relates to an adapter for filling an injector.
  • a preferred embodiment of the adapter includes a filling conduit defining a filling channel that has first and second ends and is configured for transferring a fluid, such as a medicament therebetween.
  • a first fitting is disposed at the first end of the channel and configured for mating with a fluid container for receiving fluid therefrom and for feeding the fluid into the channel.
  • a second fitting disposed at the second end of the channel and configured for mating with a injection device, preferably with out relying on piercing by a needle of the device.
  • the preferred embodiment of the second end of the channel is configured for association with a needle-free injection device, for feeding the fluid into the injection device.
  • a barrier is disposed within the channel and having a closed configuration forming a sterile barrier in the channel between the first and second ends and an open configuration for allowing the fluid to bypass the barrier through the channel between the first and second ends.
  • the fluid container is a syringe
  • the first fitting is configured for mating with a nozzle of the syringe.
  • the second fitting is configured for releasably mating with the injection device.
  • the barrier can include a piston movable from a closed position in the channel in the closed configuration to an open position in the channel in the open configuration.
  • the barrier can also be pierceable by a needle of the adapter that extends into the fluid channel for configuring in the open configuration and can include a membrane.
  • Another embodiment has a bypass channel configured for fluidly communicating portions of the filling channel on opposite sides of the barrier in the open configuration.
  • At least one of the fittings is preferably a threaded fitting, such as a Luer fitting.
  • a fitting such as a Luer fitting.
  • Another type of fitting that can be used is resiliently movable for resiliently mating with the container or injection device and can comprise a resilient finger configured for resiliently gripping the mated container or injector.
  • a cap can be provided on at least one of the first or second ends of the filling channel.
  • the preferred adapter has a seal configured for sealing a space between the injection device and adapter to seal against leakage therefrom during the filling of the injection device.
  • the preferred injection device includes an energy source and an associated jet nozzle with a jet orifice configured for producing a jet configured and with sufficient power for penetrating the epidermis of a patient and delivering the jet of the fluid to the injection site, the orifice being configured for receiving the fluid from the channel to fill the injector.
  • the energy source is associated with the jet nozzle orifice for delivering the fluid at a pressure sufficiently high to produce a jet of the fluid that penetrates further into the patient, substantially past the jet nozzle, to an injection site.
  • a preferred injection apparatus includes the injection device, which can have a fluid chamber configured for containing a fluid for injection.
  • the barrier has a pierceable seal, with a needle of the adapter configured for piercing the seal for opening the barrier.
  • a syringe filled with a fluid is attached to a fitting on one end of an adapter.
  • An injection device is mated to a second end of the adapter, and fluid is transferred from the syringe into the injection device through a fluid channel in the adapter. The injection device is separated from the adapter.
  • the syringe is preferably attached to the fitting by moving a barrier within the adapter towards the second end of the adapter, which may open a bypass channel for transferring the fluid therethrough.
  • the preferred method also includes reconstituting a medicament in the syringe to produce the fluid.
  • Fig. 1 is a cross-sectional view of an embodiment of an adapter constructed according to the present invention prior to connection with a syringe;
  • Fig. 2 is a cross-sectional view thereof connected to the syringe;
  • Fig. 3 is a cross-sectional view thereof during filling of an injection device;
  • Fig. 4 is a cross-sectional view of an injection device attached to the adapter;
  • Fig. 5 is a cross-sectional view of another embodiment with bypass channels;
  • Fig. 6 is a cross-sectional view thereof connected to a syringe, during the filing of an injection device;
  • Fig. 7 is a cross-sectional view of the adapter with a sterile end cap on each end of the adapter;
  • Fig. 8 is a cross-sectional view of another embodiment of an adapter with a flexible membrane.
  • the invention relates to an adapter 15 for transferring a fluid from one container to another container.
  • the containers include a syringe 20 and a needle-free injection device 12, although other suitable containers may be used.
  • the adapter 15 includes a filling channel 16 having two ends. A fitting on a first end 29 of the adapter 15 is configured to mate with a syringe 20, whereas a fitting on the second end 28 of the adapter 15 is configured to mate with an injection device 12 so the fluid may flow from the syringe 20, through the channel 16, and into the injection device 12.
  • the adapter 15, and preferably the channel 16 and portions in contact with the fluid during filling are preferably made of a material compatible with a fluid medicament, so as not to adversely affect the medicament, as known in the art.
  • the preferred adapter 15 includes a barrier 18 disposed within the fluid channel 16 between the two ends.
  • the barrier 18 has a closed configuration and an open configuration and can be placed in the open configuration independently of any needle of the injection device.
  • Fig. 1 shows the barrier 18 in the closed configuration
  • Fig. 2 shows the barrier in the open configuration.
  • the barrier 18 in the closed configuration preferably forms a sterile barrier between the two ends, sealing the channel 16, while in the open configuration it permits the fluid to be transferred from the syringe 20 to the injection device 12.
  • the barrier 18 in the closed configuration seals the fluid chamber 16 to prevent fluid from moving from the syringe 20 to the injection device 12 until it is switched to the open configuration.
  • the barrier 18 includes a stopper that is movable within the fluid chamber 16.
  • Syringe 20 has nozzle 25 on the end through which the fluid exits when displaced by piston 26. When inserted in the channel 16, the nozzle 25 abuts the barrier 18 to push the barrier 18 toward the opposite end of the fluid channel 16. Alternatively, fluid pressure produced by the syringe 20 displaces the barrier 18.
  • the syringe 20 can be threadably connected to the adapter 18, such as by a Luer fitting 31 with the nozzle 25 received in sealed association with the first end 29 of the adapter, preferably such that the adapter 15 and syringe can be readily attached and detached from each other.
  • a Luer fitting 31 with the nozzle 25 received in sealed association with the first end 29 of the adapter
  • other suitable structures for mounting or attaching two components can be utilized to detachably mate the syringe 20 to the adapter 15.
  • Other fittings that may be used to connect the adapter 15 to the syringe 20 include a snap-fit connection, such as with radially movable fingers to obtain a releasable snap-fit connection.
  • the fitting can comprise a seal to create a fluid seal around the interface between the channel 16 and the nozzle orifice 72 of the nozzle 25, or a separate seal may be provided to prevent leakage during filling.
  • the injection device 12 and the adapter 15 are configured to be connected to each other at the opposite end of channel 16 from the syringe 20.
  • the adapter includes an injector-side wall 14 that mates and seals the injector side of the channel 16 to the injection device 12, and preferably to an injection nozzle 68 with a jet opening 72 that is configured for ejecting a jet of the fluid of a configuration and velocity sufficient to penetrate the skin and tissue of a patient to an injection site substantially remote from the nozzle, as known in the art.
  • the wall 14 includes a seal 17 that seals the channel 16 to the injecting device 12.
  • the channel 16 preferably includes a narrow portion 70 with a smaller cross-section than syringe portion 74 of the channel 16, closer to the diameter of the jet nozzle opening. Between the narrow portion 70 of the channel 16 and the nozzle opening 72, within the seal 17, is an enlarged chamber 76 configured to provide a tolerance between the alignment of the channel 16 and the nozzle opening 72 to permit the fluid to flow therebetween.
  • the seal 17 is preferably round, although other shapes are employable, and is preferably molded from as a unitary piece of the adapter 15 of a sufficiently resilient material.
  • the material of the seal is preferably sufficiently deformable to seal the fluid within the chamber 76, to seal the gap between the adapter 15 and the nozzle 68 when the pressure within the chamber 76 and channel 16 is increased by the operation of the syringe 20 during filling of the injecting device 12.
  • the seal can alternatively be made from a separate piece, such as an O-ring associated with the adapter body.
  • a needle 13 of the adapter 15 is configured to puncture and pass through the barrier 18 to permit the fluid to flow from the syringe 20 into the injection device 12, such as when the nozzle 25 of the syringe 20 of the fluid from the syringe pushes the barrier 18 towards the needle 13 of the injection device 12.
  • the barrier 18 thus opens and fluidly connects the portions of the channel 16 or opposite sides of the barrier from the fluid channel 16.
  • Needle 13 preferably extends from wall 14 and includes in its interior the narrow channel portion 70.
  • the preferred injection device 12 has a ridge 19 extending outwardly, such as from the nozzle 68, which may be formed of a resilient material.
  • the adapter 15 has a receptacle 21 configured to receive and engage ridge 19, and which is preferably of corresponding size to the ridge 19, such that the resilient outer diameter of the injection device 12 is squeezed within the adapter 15 and fits snugly within the receptacle 21 in the adapter 15.
  • the receptacle 21 preferably includes a circumferential groove.
  • the injector attachment end 28 of the adapter 15, which is preferably larger than the syringe end 29 to receive a portion of the injection device 12, is configured to resiliently connect to and release ridge 19, which can be made of stiffer construction.
  • the adapter may be formed with a ridge or other protrusion configured to be received in a receptacle of the injection device.
  • connection is transferred from a syringe 20 to the injection device 12.
  • the user attaches the syringe 20 filled with a fluid to an adapter 15 by a suitable fitting as described above.
  • the other end of the adapter 15 is mated to the injection device 12 to form a fluid channel 16 through the adapter 15.
  • the fluid 52 is then transferred from the syringe 20 to the injection device 12 through the fluid channel 16.
  • the injection device 12 is then separated from the adapter 15 and the syringe 20, which may remain connected to each other.
  • a syringe 20 filled with a diluent is attached to a vial containing a lyophilized drug.
  • the diluent is injected into the vial from the syringe 20 to reconstitute the drug, which is then redrawn into the syringe 20.
  • the syringe 20 is withdrawn from the vial and attached to the adapter 15 on the injection device 12.
  • the reconstituted drug is transferred from the syringe 20, through the adapter 15, and into the injection device 12.
  • the mating between the adapter 15 and the syringe 20 preferably permits the user to remove them from the injection device 12 as one piece.
  • the adapter 15 and syringe 20 are removed from the injection device 12.
  • the injection device 12 is placed on the injection site on the patient for injection of the drug.
  • fluid chamber 62 is sealed by plunger 67, which is slideably received in chamber 62.
  • plunger 47 Prior to injection, as the injection device 12 is being filled with fluid, plunger 47 is forced back towards the proximal or back end of the injector by the fluid entering the medicament chamber 62 until it seats itself onto the end of a ram 37.
  • Protrusion 60 of the ram 37 fits within receptacle 57 of the plunger 47.
  • the ram 37 comprises a rim 64 associated with the chamber 62 wall to help radially stabilize the ram 37, as well as to abut the plunger 47, and along with the protrusion 60, forces the plunger 47 forward to inject the fluid.
  • the nozzle 68 is pressed against the injection site, and trigger 144 is pressed.
  • the trigger 144 is associated with 142 in the proximal end of the injector, which releases ram 37.
  • An energy source of a power pack 81 of the injecting device such as a compressed gas or other spring 134, biases and moves the ram 37 distally, injecting the liquid through the nozzle orifice 72.
  • the adapter 56 embodiment of Figs. 5 and 6 defines bypass channels 54 that are closed or blocked off from the first end 29 of the channel 16, closing the channel 16, when the barrier 18 is disposed in the position of Fig. 5 in the closed configuration.
  • the syringe 20 preferably displaces the adapter towards the second end 28, and when fluid is injected into the channel 16 by the syringe 20, the fluid displaces the barrier 18 further towards the second end 28.
  • Stops or the wall 14 can be used to keep the barrier 18 from being displaced past the open configuration position.
  • stops 58 keep the needle 13 from piercing the barrier 18.
  • the barrier 18 is preferably shorter axially than the bypass channels 54 such that in the open configuration, axially opposite ends of the bypass channels 54 are open and in fluid communication with the channel 16 on opposite sides of the barrier 18, thus allowing fluid to flow therethrough from the syringe to the injector.
  • the bypass channels 54 preferably extend into the wall 14 and connect with the narrow channel portion 70 around the axial end of the barrier 18.
  • the barrier has channels that are blocked by a portion of the adapter in the closed configuration, and which are open on both sides of the barrier 18 in the open configuration, such as when the barrier 18 is moved away from the portion of the adapter that previously blocked them, to allow filling of the injector.
  • the adapter 15 has an end cap 32 on each end of the adapter 15.
  • the end caps 32 form sterile seals with the adapter channel 16 to prevent contamination prior to use.
  • at least one end cap 32 is connected to the adapter 15 by threads, a snap-off connection, quick-connects, or other connections.
  • a barrier includes a flexible, pierceable material, preferably comprising a membrane 44 that can be fixed to or slide with respect to the channel 16.
  • the membrane 44 is pierced by needle 13 when moving from the closed to the open configuration due to the fluid pressure produced by the syringe injecting the fluid into the channel 16.
  • the position of the membrane 44 in the open configuration is shown in the figure.
  • the membrane 44 is preferably impermeable to the fluid to be transferred.
  • the membrane and the rest of the adapter are preferably formed of a sterile material useable for medical applications.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un adaptateur permettant de transférer un fluide, tel un médicament, depuis une seringue vers un dispositif d'injection Cet adaptateur comprend une barrière afin de permettre le transfert du fluide dans un environnement stérile. Cet adaptateur forme un canal fluidique présentant une configuration fermée et une configuration ouverte. Cet adaptateur comprend un raccord configuré de manière à venir en prise avec la seringue, ainsi qu'un deuxième raccord configuré pour venir en prise avec le dispositif d'injection. L'invention concerne aussi un dispositif d'injection utilisant cet adaptateur.
PCT/US2003/032410 2002-10-10 2003-10-10 Adaptateur de remplissage pour injecteur sans aiguille Ceased WO2004032997A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003287060A AU2003287060A1 (en) 2002-10-10 2003-10-10 Needleless injector filling adapter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41715602P 2002-10-10 2002-10-10
US60/417,156 2002-10-10

Publications (3)

Publication Number Publication Date
WO2004032997A2 true WO2004032997A2 (fr) 2004-04-22
WO2004032997A3 WO2004032997A3 (fr) 2004-06-24
WO2004032997A9 WO2004032997A9 (fr) 2004-08-05

Family

ID=32093976

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/032410 Ceased WO2004032997A2 (fr) 2002-10-10 2003-10-10 Adaptateur de remplissage pour injecteur sans aiguille

Country Status (2)

Country Link
AU (1) AU2003287060A1 (fr)
WO (1) WO2004032997A2 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1952837A1 (fr) 2007-01-30 2008-08-06 F.Hoffmann-La Roche Ag Dispositif destiné au transvasement d'une substance
WO2010034381A1 (fr) * 2008-09-25 2010-04-01 Lts Lohmann Therapie-Systeme Ag Injecteur et système à deux chambres avec composants stériles
EP2364743A1 (fr) * 2010-03-08 2011-09-14 LTS LOHMANN Therapie-Systeme AG Procédé et dispositif destinés au remplissage d'un injecteur à usage unique
CN112804981A (zh) * 2018-10-04 2021-05-14 株式会社大赛璐 转接器、以及射出液的转移方法
US11554215B2 (en) 2017-06-08 2023-01-17 Novartis Ag Injection device and injection solution transferring system
WO2025003228A1 (fr) * 2023-06-27 2025-01-02 Intervet International B.V. Système d'injection

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3729031A (en) * 1971-12-06 1973-04-24 Mpl Inc Liquid dispenser and plunger and method and apparatus for filling same
US6681810B2 (en) * 1994-12-20 2004-01-27 Aradigm Corporation Filling device for a needleless injector cartridge
US6474369B2 (en) * 1995-05-26 2002-11-05 Penjet Corporation Apparatus and method for delivering a lyophilized active with a needle-less injector

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1952837A1 (fr) 2007-01-30 2008-08-06 F.Hoffmann-La Roche Ag Dispositif destiné au transvasement d'une substance
WO2008092484A1 (fr) * 2007-01-30 2008-08-07 F. Hoffmann-La Roche Ag Dispositif pour transvaser une substance
WO2010034381A1 (fr) * 2008-09-25 2010-04-01 Lts Lohmann Therapie-Systeme Ag Injecteur et système à deux chambres avec composants stériles
JP2012503506A (ja) * 2008-09-25 2012-02-09 エルテーエス ローマン テラピー−ジステーメ アーゲー 無菌構成材を有する注射器及びデュアルチャンバーシステム
US8708951B2 (en) 2008-09-25 2014-04-29 Lts Lohmann Therapie-Systeme Ag Injector and dual-chamber system having sterile components
EP2364743A1 (fr) * 2010-03-08 2011-09-14 LTS LOHMANN Therapie-Systeme AG Procédé et dispositif destinés au remplissage d'un injecteur à usage unique
US11554215B2 (en) 2017-06-08 2023-01-17 Novartis Ag Injection device and injection solution transferring system
CN112804981A (zh) * 2018-10-04 2021-05-14 株式会社大赛璐 转接器、以及射出液的转移方法
WO2025003228A1 (fr) * 2023-06-27 2025-01-02 Intervet International B.V. Système d'injection

Also Published As

Publication number Publication date
WO2004032997A9 (fr) 2004-08-05
AU2003287060A1 (en) 2004-05-04
AU2003287060A8 (en) 2004-05-04
WO2004032997A3 (fr) 2004-06-24

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