AU2005200676A1 - Safety injection device for a liquid or semi-solid composition - Google Patents

Description

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Applicant: SOCIETE DE CONSEILS DE RECHERCHES ET D'APPLICATIONS SCIENTIFIQUES, S.A.S.

Invention Title: SAFETY INJECTION DEVICE FOR A LIQUID OR SEMI-SOLID

COMPOSITION

The following statement is a full description of this invention, including the best method of performing it known to me/us:

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SAFETY INJECTION DEVICE FOR A LIQUID OR C SEMI-SOLID COMPOSITION BACKGROUND OF THE INVENTION The invention relates to a device for the parenteral administration through a needle of 0 liquid or semi-solid drug compositions wherein the needle is protected before and after

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c the injection.

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oThe parenteral introduction of pharmaceutically active compounds is preferred over oral dosage for many indications, e.g. where the drug to be administered would partially or totally degrade in the gastrointestinal tract or where there is need for rapid biological response. The need for extratemporaneous preparation of such parenteral compositions is eliminated, or simplified, by the use of pre-filled administration devices in which the liquid to be injected is pre-loaded into the device a pre-loaded syringe). Such pre-loaded devices, however, have a number of drawbacks, including the inability to preserve the asepsis or sterility of the needle, as well as the general danger of using an exposed needle. To eliminate these drawbacks, it is necessary to avoid the direct exposure of the needle with the environment both prior to and following injection.

SUMMARY OF THE INVENTION The invention features a comparatively inexpensive injection device with a needle for parenteral injection of liquid or semi-solid drug compositions into a subject, e.g. a mammal such as a human, wherein the needle is protected before and after the injection.

According to the present invention there is provided an injection device for injecting a liquid or semi-solid composition into a subject, the device comprising: a reservoir having a proximal end and a distal end, said distal end being configured to contain a liquid or semi-solid composition; a hollow needle, said needle affixed to the distal end of the reservoir and extending longitudinally outside said reservoir; a plunger arranged to slide within the proximal end of the reservoir; and -3

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a plunger housing connected to said plunger, said plunger housing configured to cover said plunger, said reservoir and said needle after injection; IN wherein the device is configured such that when the plunger housing is urged around the reservoir, the plunger is urged into the reservoir, and the composition is urged from the reservoir through the needle and into the subject.

r In an embodiment said plunger housing is releasably connected to said plunger and said 0 plunger housing is configured to accept said proximal end of said plunger.

tf In an embodiment said plunger housing is fixedly attached to said proximal end of said 0 oreservoir after covering said needle.

According to a preferred execution mode of this injection device, said plunger housing is disconnected from said plunger due to a release mechanism into said proximal end of the reservoir. According to another preferred execution mode, the protection sleeve is designed to be locked in an irreversible manner by, mechanical means once the needle has been protected.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described below. All publications, patents, patent applications, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control.

In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

Other features and advantages of the invention will be apparent from the following detailed description, and from the claims.

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

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It will be clearly understood that, although a number of prior art publications are referred to herein, this reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art, in Australia or in any other IND country.

BRIEF DESCRIPTION OF THE DRAWINGS 5 FIG. 1 is a partial cross-sectional view of an injection device prior to use.

0 0FIG. 2 is a partial cross-sectional view of the injection device of FIG. 1 during use.

i FIG. 3 is a partial cross-sectional view of the device with the needle injected into a N subject.

FIG. 4 is a partial cross-sectional view of the injection device being withdrawn from the subject with the drug composition remaining in the subject.

FIG. 5 is a partial cross-sectional view of the injection device following complete withdrawal of the needle from the subject.

FIG. 6 is a partial cross-sectional view of the injection device through line 6-6 in FIG. 1.

FIG. 7 is a view of the sleeve of the injection device.

FIG. 8 is a partial cross-sectional view of a cartridge injection device prior to pre-introduction of the cartridge.

FIG. 9 is a partial cross-sectional view of a cartridge injection device prior to use.

FIG. 10 is a cross-sectional view of the cartridge injection device of FIG. 9 during use after connection of the cartridge to the needle.

FIG. 11 is a partial cross-sectional view of the cartridge injection device of FIG. during use after plunger setting.

FIG. 12 is a cross-sectional view of the cartridge injection device with the needle injected into a subject.

FIG. 13 is a partial cross-sectional view of the cartridge injection device being withdrawn from the subject with a drug composition remaining in the subject.

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FIG. 14 is a partial cross-sectional view of the cartridge injection device following complete withdrawal of the needle from the subject.

IFIG. 15 is a cross-section of the injection device through line 6-6 in FIG. 8.

FIG. 16 is a cross-section of a cartridge containing a liquid or semi-solid composition.

r- 5 FIG. 17 is a cross-section of a cartridge containing a liquid and a dry drug: o I 7A: prior to rehydration; 1713: after rehydration.

O FIG. 18 is a cross-section of the housing with the two options or the cartridge (right) and the tube (left).

FIG. 19 is a cross-section of the tube containing a liquid and a dry drug before and after rehydration.

FIG. 20 is a cross-section view at the stage of FIG. 10 in a case where tube containing a liquid and a dry drug before and after rehydration.

FIG 21 is a cross-section view of a reservoir injection device prior to use.

FIG 22 is a cross-sectional view of the reservoir injection device after drug composition injection.

FIG 23 is a cross-sectional view of the reservoir injection device following complete withdrawal of the needle from the subject.

DETAILED DESCRIPTION It is believed that one skilled in the art can, based on the description used herein, utilize the present invention to its fullest extent. The following specific embodiments are, therefore, to be construed as merely illustrative, and not limiting.

FIG. 1 shows injection device 1 including housing 10, having a proximal end and a distal end 14a, 14b. The distal end of the housing 10 has two holes 40a and 40b partially separating the two parts 14a and 14b of said distal end (as best seen in FIG. Needle 12 is attached to part 14a of the distal end. The housing 10 can be made from a suitably rigid material such as glass, plastic, metal, and the like. The needle 12 is hollow and double- -6-

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ended, wherein its distal end, remaining outside housing 10, has a point capable of piercing the skin of a subject, and its proximal end, remaining within housing 10, is capable of piercing septum plunger 16. On the proximal end of housing 10 is a flange 28 IN to assist in removal of device 1 from the subject following injection.

A sleeve 22 surrounds needle 12 so that needle 12 is not fully exposed to the environment Iuntil used. Sleeve 22 has longitudinal slots 45a and 45b along its length (see FIG. 7; slot I 45b is on the back of the sleeve and is thus not shown). The two parts 14a and 14b of the odistal end are joined by radially extending connecting members 42a and 42b (see FIG. 6).

Connecting members 42a and 42b, respectively, slide through slots 45a and 45b in sleeve O 0 22, while sleeve 22 slides through holes 40a and 40b in housing 10. Sleeve 22 can be 0 made of suitably rigid material, such as metal, glass, plastic, and the like. Seal 24 covers the opening 23 of sleeve 22 to maintain the sterility of needle 12 and prevent sleeve 22 from unintentionally retracting into housing 10 through holes 40a and 40b prior to injection.

Seal 24 can be made of a thin material, such as plastic or wax, which is easily penetrated by needle 12 during injection. A similar seal can also cover slots 45a and 45b in sleeve 22, to further protect the sterility of needle 12.

Septum plunger 16, contained within housing 10, includes a bore 26, in which needle 12 rests prior to subsequently piercing septum plunger 16. A liquid or semi-solid composition 20 is isolated in housing 10 between the septum plunger 16 and the plunger tip 30, attached to plunger 29. Septum plunger 16 and plunger tip 30 may be made of non-rigid, solid material such as rubber, polybromobutyl, and the like, which allows septum plunger 16 and plunger tip 30 to slide within housing 10 but still maintain sufficient friction with the inner sides of housing 10 to seal composition 20 within housing The proximal end of plunger 29 has a thumb flange 18 to assist in the depression of plunger 29 into housing 10, and the distal end of plunger 29 has a longitudinal bore 27 to receive needle 12 following injection of composition 20 out and through needle 12.

Plunger 29 can be made from a suitably rigid material, such as glass, metal, plastic, and the like. A removable lock 25 may be placed between flange 18 and flange 28 to inhibit further depression of plunger 29 into housing 10 after activation of the device 1, i.e. after the housing 10 is filled with a drug composition and the proximal end of the needle is -7-

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pierced through septum plunger 16. A removable cap 21 can also be used to protect both needle 12 and sleeve 22 prior to use. Both cap 21 and lock 25 can be made from suitably rigid material such as plastic, metal, rubber, and the like.

FIG. 2 shows device 1 wherein plunger 29 has been pressed into housing 10 to activate device I as follows. When plunger 29 is depressed, plunger tip 30, composition 20, and Nseptum plunger 16 are displaced towards the distal end of housing 10. Septum plunger 16 a is pierced at bore 26 by needle 12. As a result, the proximal end of needle 12 is exposed oto composition 20. Device 1 is now in an activated state. Lock 25, by contacting both flange 18 and flange 28, inhibits the further displacement of composition 20 from housing S10 10 to needle 12 following activation of device 1, i.e. composition 20 is allowed to fill

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0, needle 12, but lock 25 inhibits significant release of composition 20 through needle 12.

FIG. 3 shows device 1 wherein needle 12 has penetrated skin 32 of the subject being treated. As device I is pressed against skin 32, sleeve 22 is retracted into housing through holes 40a and 40b, by the force of pressure against skin 32. Needle 12 passes through sleeve 22 at opening 23. As shown, needle 12 has penetrated through skin 32 into the subcutaneous layer 34.

FIG. 4 shows device 1 wherein lock 25 has been removed and plunger 29 has been depressed, which moves plunger tip 30 toward septum plunger 16, thereby injecting composition 20 into subcutaneous layer 34 through needle 12. Once composition 20 has been injected and plunger tip 30 rests against septum plunger 16, housing 10 is moved away from skin 32 by exerting pressure against the lower part of the flange 28 while simultaneously exerting oppositing pressure on flange 18 of plunger 29. This relative movement of the plunger 29 and housing 10 causes plunger tip 30 to force septum plunger 16 against sleeve 22 as both plunger tip 30 and septum plunger 16 slide towards parts 14a and 14b of the distal end of housing 10, which in turn forces sleeve 22 out of housing 10 through holes 40a and 40b. As plunger tip 30 and septum plunger 16 are moved toward distal end of housing 10, needle 12 penetrates septum plunger 16, plunger tip 30, and enters bore 27 in plunger 29.

FIG. 5 shows needle 12 fully withdrawn from skin 32 and sleeve 22 fully covering needle 12. Composition 20 remains in the subcutaneous layer of the patient. As can also be seen in FIG. 5, the proximal end of needle 12 has been pushed through septum plunger 16 and plunger tip 30 and remains in bore 27 of plunger 29.

0 0 FIG. 6 is a cross-sectional view of FIG. 1 at 6-6. FIG. 6 shows holes 40a and 40b in housing 10. Radially extending connecting members 42a and 42b extend through slots and 45b, respectively, to connect parts 14a and 14b of the distal end. Needle 12 is fixed to central part 14a of the distal end, and sleeve 22 can slide through holes 40a and IN FIG. 7 shows an isolated sleeve 22 having slots 45a and 45b (45b is not shown but I positioned directly opposite to slot 45a on the other side of sleeve 22) and opening 23.

oRadially extending connecting members 42a and 42b, respectively, slide through slots and 10 FIG. 8 shows a cartridge injection device 1 including a housing 10 having a proximal and ci a distal end.

The distal end of housing 10 has at least one hole and for example two holes, 40a and partially separating the two parts of the distal end (as best seen in FlG. 15). Needle 12 is attached to the distal end. The housing 10 can be made from a suitably rigid material such as glass, plastic, metal, and the like. The needle 12 is hollow and double-ended, wherein its distal end, remaining outside housing 10, has a point capable of piercing the skin of a subject, and its proximal end remaining within housing 10 is capable of piercing septum cap 17 and septum plunger 30 of the cartridge or tube 11. On the proximal end of housing 10 is a flange 28 to assist in injection. The removal of device 1 from the subject following injection is assisted by extension of sleeve 22, A sleeve 22 surrounds needle 12 so that needle 12 is not fully exposed to the environment until used. Sleeve 22 has at least one longitudinal slot along its length, and for example two, 45a and 45b (see FIG. 15). The two parts of the distal end are joined by radially extending connecting members 42a and 42b (see FIG. 15). Connecting members 42a and 42b respectively slide through slots 45a and 45b in sleeve 22, while sleeve 22 slides through holes 40a and 40b in housing 10. Sleeve 22 can be made of suitably rigid material such as glass, plastic, metal and the like.

A seal 24 (not shown) on needle 12 can be made of a thin material, such as a plastic sheet, a plastic packaging material or a bag which is easily penetrated by needle 12 during injection. A similar seal can also cover the sleeve 22 to further protect the sterility of the needle 12.

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0 ,1 Septum plunger 16, contained within housing 10, can include a bore 26 in which needle 12 rests prior to subsequently piercing septum plunger 16. A liquid or semi-solid composition 20 is isolated in the cartridge 11 between septum plunger 16 and plunger tip IN 30. Septum plunger 16 and plunger tip 30 may be made of non-rigid solid material such as rubber, polybromobutyl, or the like, which allows plunger tip 30 to slide within Icartridge 11 but maintaining sufficient friction with the inner sides of the cartridge 11 to rseal composition 20 within cartridge 11.

0 O The proximal end of plunger 29 has a thumb flange 18 to assist in the depression of plunger 29 into cartridge 11 and the distal end of plunger 29 has a longitudinal bore 27 to O to receive needle 12 following injection of composition 20 out and through needle 12 (see

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0, FIG. 11). Plunger 29 can be made from a suitably rigid material such as glass, plastic, metal and the like. A removable lock 25 may be placed between flange 18 and flange 28 to inhibit the further depression of plunger 29 into housing 10 after activation of device 1, i.e. after the housing 10 is filled with a tube or a cartridge and the proximal end of the needle is pierced through septum cap 17.

A removable cap 21 can also be used to protect both needle 12 and sleeve 22 prior to use.

Both cap 21 and lock 25 can be made from suitably rigid material such as plastic, metal, rubber, and the like Septum cap 17 on distal end of cartridge 11 is sealed, with a metal ring (not shown).

A liquid or semi-solid composition 20 is isolated in cartridge or tube 11 between the septum cap 17 and the plunger tip 30, which will be attached to plunger 29 (see FIG. 11).

The cartridge or tube 11 can be connected to the proximal end of needle 12 by applying pressure to the proximal end of the cartridge or tube, by pushing with the thumb (see FIG. Septum cap 17 and plunger tip 30 may be made of non-rigid material such as rubber, polybromobutyl, and the like, which allows needle 12 to pierce septum cap 17 and plunger tip 30, and allows plunger tip 30 to slide sealably within cartridge or tube 11.

FIG. 9 shows, during use of device 1, the introduction of cartridge or tube 11 into the housing FIG. 10 shows the connection of cartridge or tube 11 on needle 12 through septum cap 17.

(N FIG. 11 shows settlement of plunger 29 on plunger tip d SFIG. 12 shows injection of needle 12 with retraction of sleeve 22 into housing Va FIG. 13 shows injection of composition 20 into the tissue, using thumb on plunger flange 18 and the other fingers on housing flange 28.

Va r7- 5 FIG. 14 shows removal of the device from the subject following injection, where Va o cartridge or tube 11 urges sleeve 22 from housing 10 around needle 12 and, consequently, O removes needle 12 from body tissue.

oFIG. 15 shows a cross-section, through line 6-6 shown in FIG. 8, of distal end 14b of 0, housing 10 with two apertures or holes 40a and 40b through which slots 45a and 45b of sleeve 22 slide. Two connecting members 42a and 42b separate the holes and connect external part of the housing 10 with the internal part where needle 12 is fixed.

FIG. 16 shows a cartridge or tube 11 used in the housing 10 of device 1 with composition between septum cap 17 and plunger tip FIG. 17A shows a cartridge or tube 11 used in the housing 10 of device 1 with a releasable lock 50. The liquid part of the composition 20B is loaded in cartridge or tube 11 between two septum plunger 30A and septum plunger 30B. Septum plunger 30A is placed into cartridge or tube 11 just before by-pass 51. Septum plunger 30B is locked with the lock 50 in contact with cartridge or tube 11. The solid part of the composition is loaded, under vacuum, in cartridge or tube 11 between septum plunger and septum cap 17.

FIG. 17B shows cartridge or tube 11 of FIG. 17A after removal of the releasable lock The composition 20 is prepared by passage of the liquid part of the composition through the by-pass 51 into the solid part under vacuum.

FIG. 18 shows device 1 with the tube option 11A or the cartridge option lIB presented with the dual chamber arrangement of FIG. 17. The housing 10 can be the same for both options (I1A or 11B). Before removal of releasable lock 50, tube I1A or cartridge 111 cannot be connected on needle 12 through septum cap 17. After removal of releasable lock 50, the rehydration is realized as described in FIG. 17 or FIG. 19 and tube 11A or cartridge 11B can be operably connected to needle 12. The plunger 29 is attached to septum plunger 30B and the injection is performed.

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CFIG. 19 shows, for tube 11A, the rehydration process described in FIG. 17, performed by removing lock 50. Before removing lock 50 on FIG. 12A, tube IIA cannot be introduced into the housing deep enough to introduce needle 12 through septum cap 17 into the tube ID 11A. Releasable lock 50 also maintains plunger 30A at the top of by-pass 51 despite the vacuum in the solid part of the composition 20A. After removing lock 50 on FIG. 12B, tube 11A can be introduced into the housing to introduce needle 12 through septum cap r- 17 into the tube 1IA. Before this introduction by removing lock 50, the composition 20 is o prepared by mixing the solid part 20A and the liquid part 20B due to the rehydration Oobtained by the vacuum of the chamber containing solid part O o10 FIG. 20 shows 2 possible variations in the arrangement of FIG. 8 during use after connection of the cartridge or tube 11 on the needle 12 when the needle 12 is not directly attached to the distal end of housing 10 but to a support 50 which corresponds to distal end of housing 10 in the way sleeve 22 is affixed to it.

This independent support 50 can be connected to housing 10, like a pen or cartridge disposable needle is connected, by screwing onto housing 10 after needle 12 is introduced through septum cap 17.

In FIG. 20A, the removal of the device from the subject following injection is obtained by sleeve 22 as in FIG. 8 due to the displacement of cartridge or tube 11.

FIG. 20B shows another alternative where the extension of sleeve 22 after injection is facilitated by spring 51 without displacement of cartridge or tube 11. This allows the thread to be a standard one and the device to be adapted on any other existing cartridge pen or syringe injector.

FIG. 21 shows injection device 1, including reservoir 10, having a distal end 14a and a proximal end 14b. The proximal end of the reservoir 10 has two holes 40a and adapted to operatively accept arms 22a and 22b. Needle 12 is operatively attached to distal end 14a. Reservoir 10 can be made from a suitably rigid material such as glass, plastic, metal, or the like. The needle 12 is hollow and single-ended outside the reservoir with a tip capable of piercing the skin of a subject. On the proximal end of housing is a flange 28 having, an elliptic shape, which assists both plunger movement in the reservoir and removal of device 1 from the subject via extension of sleeve 22 following injection.

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0 l In this embodiment the sleeve 22 comprises a plunger housing made of a suitably rigid material such as metal, glass, plastic, or the like. The plunger housing 22 surrounds plunger 29 so that when plunger 29 slides into reservoir 10, plunger housing 22 slides IND around reservoir 10. Plunger housing 22 has longitudinal slots (not shown) and arms 22a and 22b along its length. Arms 22a and 22b pass through holes 40a and 40b respectively in the proximal end 14b.

IND The proximal end of plunger 29 is covered by plunger housing 22 up to a flange 18.

oFlange 18 assists depression of plunger 29 into reservoir 10 along with simultaneous depression of plunger housing 22 around reservoir 10 due to the removable lock 17 or O 10to connection means with plunger 29 into plunger housing 22.

0 FIG. 22 shows device I as depicted in FIG. 21 wherein plunger 29 has been depressed by plunger housing 22 thereby injecting composition from reservoir 10 through needle 12.

Once composition has been injected plunger 29 rests against the bottom or distal end of reservoir 10, which is also completely covered by plunger housing 22.

is Reservoir 10 is then moved away from the injection needle site by exerting pressure against the lower part of the flange on proximal end 14b of the reservoir 10 while simultaneously exerting opposing pressure on flange 18 of plunger housing 22. This relative movement of the plunger housing 22 and reservoir 10 causes plunger 29 to be released from removable lock 16 due to sliding guide and release mechanism on reservoir proximal end 14b, and plunger housing slides around reservoir 10 and needle 12, which in turn urges needle 12 out of injection site.

FIG. 23 shows needle 12 fully withdrawn from the injection site and plunger housing 22 covering reservoir 10 and needle 12.

Flange 18 is equipped with means 46 to secure, optionally irreversibly, the plunger housing 22 once the needle 12 has been protected.

Composition 20 is a liquid or a semi-solid composition containing a drug. The drug of composition 20 can be any drug capable of being parenterally administered as a liquid or a semi-solid. For example, the drug can be a vaccine, a peptide, a protein, or a small chemical entity. Examples of suitable drugs include, insulin and heparin. For drugs which are not stable in liquids over an extended period of time, the liquid and the dry -'13-

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drug can be stored in separate chambers within housing 10. The device can be configured such that the liquid and the dry drug are combined togetherjust prior to injection.

IFor example, the chamber created between septum plunger 16 and plunger tip 30 in FIG. 1) in housing 10 can be separated into two separate parts by a fixed wall or film that can be punctured, e.g. by pressure of the plunger 29 on the plunger tip 30, or a puncturing means. Alternatively, the two parts of the chamber can be separated by a moving wall or Iseptum. In this case, the top or proximal part of the chamber above the moving wall or oseptum contains the liquid portion of the composition, and the distal part of the chamber contains the solid, powder, portion of the composition. When plunger 29 is urged O 10 into housing 10, it applies pressure to plunger tip 30 and plunger tip 30 applies pressure

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ci to the liquid portion of the composition. This, in turn, applies pressure on the moving septum, causing it to move in a distal direction. The housing is configured with a liquid bypass a bulge or passage in the housing wall) in a location that initially prevents passage of liquid from one part of the chamber to the other, but when the moving septum reaches a specific location, the bypass allows the liquid to pass from the top or proximal part of the chamber into the lower or distal part of the chamber on the other side of the moving septum.

To maintain sterility, the device of the invention can be stored in a conventional blister pack or pouch prior to use.

OTHER EMBODIMENTS It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the appended claims. Other aspects, advantages, and modifications are within the claims.

Claims (4)

1. An injection device for injecting a liquid or semi-solid composition into a subject, the device comprising: Vs 5 a reservoir having a proximal end and a distal end, said distal end being configured to o contain a liquid or semi-solid composition; o a hollow needle, said needle affixed to the distal end of the reservoir and extending O longitudinally outside said reservoir; a plunger arranged to slide within the proximal end of the reservoir; and a plunger housing connected to said plunger, said plunger housing configured to cover said plunger, said reservoir and said needle after injection; wherein the device is configured such that when the plunger housing is urged around the reservoir, the plunger is urged into the reservoir, and the composition is urged from the reservoir through the needle and into the subject.

2. A device as claimed in claim I wherein said plunger housing is releasably connected to said plunger and wherein said plunger housing is configured to accept said the proximal end of said plunger.

3. A device as claimed in claim 2, wherein said plunger housing is fixedly attached to said proximal end of said reservoir after covering said needle.

4. An injection device as claimed in claim 1, substantially as hereinbefore described with reference to the drawings. Dated this I 5th day of February 2005 SOCIETE DE CONSEILS DE RECHERCHES ET D'APPLICATIONS SCIENTIFIOUES, S.A.S. By their Patent Attorneys GRIFFITH HACK Fellows Institute of Patent and Trade Mark Attorneys of Australia