WO2004032997A2

WO2004032997A2 - Needleless injector filling adapter

Info

Publication number: WO2004032997A2
Application number: PCT/US2003/032410
Authority: WO
Inventors: Paul R. Lesch, Jr.; Kenneth Adam
Original assignee: Antares Pharma, Inc.
Priority date: 2002-10-10
Filing date: 2003-10-10
Publication date: 2004-04-22
Also published as: WO2004032997A3; AU2003287060A8; WO2004032997A9; AU2003287060A1

Abstract

An adapter for transferring a fluid, such as a medicament, from a syringe to an injection device is disclosed. The adapter includes a barrier to permit the fluid to be transferred in a sterile environment. The adapter forms a fluid channel having a closed configuration and an open configuration. The adapter includes a fitting configured to mate with the syringe, as well as a second fitting configured for mating with the injection device. A method for transferring a fluid from a syringe to an injection device using such adapter is also disclosed.

Description

NEEDLELESS INJECTOR FILLING ADAPTER

FIELD OF THE INVENTION

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.

BACKGROUND OF THE INVENTION

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. For administration, the user must reconstitute the drug by adding a diluent to form a solution or suspension of the powder. 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.

SUMMARY OF THE INVENTION

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.

Preferably, the fluid container is a syringe, and the first fitting is configured for mating with a nozzle of the syringe. Also, 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. 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. Additionally, 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. In one embodiment, the barrier has a pierceable seal, with a needle of the adapter configured for piercing the seal for opening the barrier. In a preferred method according to the invention, 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. BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood in relation to the attached drawings illustrating preferred embodiments, wherein:

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; and

Fig. 8 is a cross-sectional view of another embodiment of an adapter with a flexible membrane.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to Figs. 1-3, the invention relates to an adapter 15 for transferring a fluid from one container to another container. As shown in the drawings, preferably, 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, while 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. Preferably, 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.

In the embodiment shown, 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. Alternatively, 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. In a preferred embodiment, 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. Alternatively, 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. Also, the adapter may be formed with a ridge or other protrusion configured to be received in a receptacle of the injection device.

Other types of connection are possible as will be recognized by those of ordinary skill in the art. Examples of such connections are snap-fit connections, threaded connections, and quick-release couplings. Preferably, the connection used seals the channel 16 against leakage of the fluid therefrom. In a preferred method according to the invention, fluid 52 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.

In an embodiment, 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.

Referring to Fig. 4, fluid chamber 62 is sealed by plunger 67, which is slideably received in chamber 62. 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. Preferably, 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.

To fire the injection device and 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. When the adapter 56 is mated to a syringe 20, 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. Preferably, 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. In another embodiment, 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. In another embodiment shown in Fig. 7, the adapter 15 has an end cap 32 on each end of the adapter 15. Preferably, the end caps 32 form sterile seals with the adapter channel 16 to prevent contamination prior to use. Preferably, at least one end cap 32 is connected to the adapter 15 by threads, a snap-off connection, quick-connects, or other connections.

Referring to Fig. 8, another embodiment of 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. In this embodiment, 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. When the fluid is a medicament, the membrane and the rest of the adapter are preferably formed of a sterile material useable for medical applications.

While it is apparent that the illustrative embodiments of the invention herein disclosed fulfill the objectives stated above, it will be appreciated that numerous modifications and other embodiments may be devised by those skilled in the art. For example, another embodiment of an adapter may have an internal needle that pierces the barrier in the open configuration, but which is not part of the injection device. Therefore, it will be understood that the appended claims are intended to cover all such modifications and embodiments which come within the spirit and scope of the present invention.

Claims

THE CLAIMSWhat is claimed is:

1. An injector-filling adapter, comprising: a filling conduit defining a filling channel that has first and second ends and is configured for transferring a fluid therebetween; a first fitting 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 needle-free injection device for feeding the fluid into the injection device; and a barrier 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.

2. The adapter of claim 1 , wherein the fluid container is a syringe, and the first fitting is configured for mating with a nozzle of the syringe.

3. The adapter of claim 1 , wherein the second fitting is configured for releasably mating with the injection device.

4. The adapter of claim 1 , wherein the barrier comprises 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.

5. The adapter of claim 4, further comprising a needle extending into the channel, wherein the barrier is pierceable by the needle for configuring in the open configuration.

6. The adapter of claim 1 , wherein the barrier comprises a membrane.

7. The adapter of claim 1 , further comprising a bypass channel configured for fluidly communicating portions of the filling channel on opposite sides of the barrier in the open configuration.

8. The adapter of claim 1, wherein at least one of the fittings is a threaded fitting.

9. The adapter of claim 1, wherein at least one of the fittings is resiliently movable for resiliently mating with the container or injection device.

10. The adapter of claim 9, wherein the resiliently movable fitting comprises a resilient finger configured for resiliently gripping the mated container or injection device.

11. The adapter of claim 1 , wherein the fluid comprises a medicament, and the filling channel is made of material compatible with the medicament.

12. The adapter of claim 1, further comprising a cap on at least one of the first or second end of the filling channel.

13. The adapter of claim 1 , further comprising 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.

14. A user finable injection apparatus, comprising: the adapter of claim 1 ; and the needle-free injection device, which is configured for injecting the fluid into an injection site.

15. The inj ection apparatus of claim 14, wherein the inj ection device comprises a jet nozzle configured delivering a jet of the fluid configured and with sufficient velocity to penetrate the skin to the injection site remotely from the jet nozzle, wherein the jet nozzle is configured for receiving the fluid from the channel to fill the injection device.

16. The inj ection apparatus of claim 15 , wherein the inj ection device comprises a fluid chamber configured for containing a fluid for injection.

17. The injection apparatus of claim 16, further comprising a needle extending into the channel, wherein the barrier is pierceable by the needle for configuring in the open configuration.

18. The injection apparatus of claim 16, wherein the adapter further comprises a bypass channel configured for opening the filling channel to transfer the fluid from to the injection device in the open configuration.

19. The injection apparatus of claim 16, further comprising 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 with the channel and nozzle in fluid communication.

20. The injection apparatus of claim 19, wherein the injection device is needle-free.

21. A method of transferring a fluid from a syringe to an injection device which comprises: attaching a syringe filled with a fluid to a fitting on one end of an adapter; mating a needle-free injection device to a second end of the adapter; transferring the fluid from the syringe into the injection device through a fluid channel in the adapter; and separating the injection device from the adapter.

22. The method of claim 21, wherein the attaching of the syringe to the fitting comprises moving a barrier within the adapter towards the second end of the adapter.

23. The method of claim 22, wherein the moving the barrier within the adapter opens a bypass channel and the fluid is transferred through the bypass channel.

24. The method of claim 21, further comprising opening the fluid channel by piercing a barrier within the adapter with an needle thereof disposed within the channel.

25. The method of claim 24, further comprising reconstituting a medicament in the syringe to produce the fluid.

26. The method of claim 21 , further comprising sealing a space between the adapter and the injection device to seal against leakage therefrom during the filling of the injection device with the channel and nozzle in fluid communication.