WO2004032996A2

WO2004032996A2 - Needle injector filling adapter

Info

Publication number: WO2004032996A2
Application number: PCT/US2003/032409
Authority: WO
Inventors: Paul R. Lesch, Jr.
Original assignee: Antares Pharma, Inc.
Priority date: 2002-10-10
Filing date: 2003-10-10
Publication date: 2004-04-22
Also published as: AU2003287059A8; WO2004032996A3; AU2003287059A1

Abstract

An adapter for transferring a fluid, such as a medicament, from a syringe to a needle-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

NEEDLE 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 a injection device that employs a injection needle 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 injection.

SUMMARY OF THE INVENTION

The invention relates to an adapter for filling an injector that uses a needle for the injection. 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 an needle-injection device, including needle- assisted jet injectors, 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 injection device 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 injection device includes a needle configured for penetrating the epidermis of a patient and delivering a jet of the fluid to the injection site, the needle being configured for receiving the fluid from the channel to fill the injector. This type of injector preferably has an energy source associated with the needle 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 needle tip, 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 preferred injection device also has an injection needle comprising a needle opening for filling the fluid into the fluid chamber and for injecting the fluid into a patient. The barrier preferably has a pierceable seal, with the injection needle 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 barrier may also be pierced, such as with an injection needle on the injection device. 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 of another embodiment of an adapter with a flexible membrane;

Fig. 4 is a cross-sectional view of another embodiment of an adapter with a pierced barrier;

Fig. 5 is a cross-sectional view of an injection device being filled with fluid from a syringe; Fig. 6 is a cross-sectional view of the adapter with a sterile end cap on each end of the adapter;

Fig. 7 is a cross-sectional view of another embodiment with bypass channels; and

Fig. 8 is a cross-sectional view thereof connected to a syringe.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to Figs. 1-2, 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 an 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 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. 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 channel 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 channel 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, and where the injecting device uses a needle to pierce the barrier, a seal between the adapter and the injection device is not necessary, although the pierced barrier preferably seals around the outside of the needle to substantially prevent leakage and resist elevated pressures during filling due to the operation of the syringe. 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 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 injection device 12 includes a needle 13 that that 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 opens and fluidly connects the portions of the channel 16 or opposite sides of the barrier from the fluid channel 16.

Referring to Figs. 5-6, 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 a needle from the injection device 12 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 closed configuration is shown in dashed lines, and the position of the membrane 44 in the open configuration is shown in solid lines. The membrane 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.

In the embodiment of Fig. 4, the needle 40 of injection device 42 penetrates barrier 44 when the adapter 46 is connected with the injection device 42. In one embodiment, needle 40 is retractable, with the tip retracting to within the forward end 48 of the injection device 42 to position 50. After the adapter 46 is connected to the injection device 42, the needle 40 moves forward and penetrates barrier 44.

Suitable injection devices with retractable and extendable needles are described in Application No. 09/779,603, filed February 9, 2001, the content of which is hereby expressly incorporated herein by reference thereto.

Referring again to Fig.l, the injection device 12 has a ridge 19 extending outwardly, 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 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. Fig. 7 depicts an embodiment of the invention device 12 having a retractable shield 42 around the needle 25. The needle 25 is held stationary by the hub 49, and the hub 49 is preferably fixed in place by the hub retainer 50.

A fluid chamber 62 is defined preferably within hub 49, and is sealed by plunger 47, 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 injector and inject the fluid, the shield 42 is pressed against the injection site and retracts to expose needle 25. The shield 42 is associated with trigger mechanism 44 in the proximal end of the injector, which releases ram 37. An energy source, such as a compressed gas or other spring, biases and moves the ram 37 distally, injecting the liquid through the needle 25. Locking ring 52 of the shield 42 engages locking member 66 of the retain hub retainer 50 to retain the shield 42 in the retracted position.

In another embodiment shown in Fig. 6, 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.

The adapter 56 embodiment of Fig. 7 defines bypass channels 54 that are closed or blocked off from the first end 29, closing the channel 16, when the barrier 18 is disposed in the position of Fig. 7 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 be the syringe 20, the fluid displaces the barrier 18 further towards the second end 28. Stops 58 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. 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.

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 CLAIMS

What is claimed is:

1. A user fillable injection apparatus, comprising: a needle-injection device comprising an injection needle configured to penetrate a patient, the injecting device being configured for injecting the fluid into an injection site in a patient through he needle; and 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 the needle-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 injection apparatus 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 injection apparatus of claim 1 , wherein the second fitting is configured for releasably mating with the injection device.

4. The injection apparatus 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 injection apparatus of claim 4, wherein the barrier is pierceable by the needle of the injection device for configuring in the open configuration, wherein the adapter is configured for filling the injecting device through the needle.

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

7. The injection apparatus 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 injection apparatus of claim 1, wherein at least one of the fittings is a threaded fitting.

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

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

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

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

13. The injection apparatus of claim 1, wherein the needle is configured for delivering a jet of the fluid to the injection site and for receiving the fluid from the channel to fill the injection device.

14. The injection apparatus of claim 1, wherein the injection device comprises a fluid chamber configured for containing a fluid for injection.

16. The injection apparatus of claim 1 , 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.

17. 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-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.

18. The method of claim 17, wherein the attaching of the syringe to the fitting comprises moving a barrier within the adapter towards the second end of the adapter.

19. The method of claim 18, wherein the moving the barrier within the adapter opens a bypass channel and the fluid is transferred through the bypass channel.

20. The method of claim 17, further comprising opening the fluid channel by piercing a barrier within the adapter with an injection needle on the injection device.

21. The method of claim 20, further comprising reconstituting a medicament in the syringe to produce the fluid.