Prefilled retractable syringe, plunger and needle assembly

• US 8,361,035 B2
• Filed: 07/02/2008
• Issued: 01/29/2013
• Est. Priority Date: 07/02/2007
• Status: Active Grant

• Current Assignee: UNL Holdings, LLC
• Original Assignee: Unitract Syringe Pty Limited (Unilife Corp.)
• Inventors: Thorley, Craig Stephen, Kaal, Joseph Hermes, Rafferty, Chris, Sokolov, Richard, Hueso, Ernesto, Wallis, Huw, Truong, Steve Chi
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US12/666,448
• Publication Number:
  US 20110015572A1
• Time in Patent Office: 1,672 Days
• Field of Search: 604195-196, 604/110, 604/187, 604/220
• US Class Current: 604/195
• CPC Class Codes: A61M 2005/3103 Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
• CPC Class Codes: A61M 2005/323 Connection between plunger distal end and needle hub proximal end, e.g. stud protruding from the plunger
• CPC Class Codes: A61M 2005/3231 Proximal end of needle captured or embedded inside piston head, e.g. by friction or hooks
• CPC Class Codes: A61M 2005/3238 Trigger provided at the proximal end, i.e. syringe end opposite to needle mounting end
• CPC Class Codes: A61M 2005/5073 by breaking or rupturing the connection parts
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/345 Adaptors positioned between needle hub and syringe nozzle
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A retractable syringe, plunger and releasable needle retaining assembly are provided. The retractable syringe typically has a glass barrel and is prefilled with fluid contents before use. The releasable needle retaining system comprises a retractable needle, a needle seal, a retaining member and an ejector member that is operable to release the retractable needle from the retaining member. The retaining member has a mating surface for mounting to a complementary mating surface of an interior wall of a syringe barrel. The plunger comprises a plunger outer, a plunger rod frangibly connected to a controlling member, a spring and a unitary plunger seal capable of engaging the retractable needle, wherein the plunger rod, plunger outer and the controlling member co-operate to releasably maintain the spring in an initially compressed state. After delivery of fluid contents of the syringe, the plunger forces the ejector member to release the retractable needle from the retaining member. Decompression of the spring at the end of depression of the plunger facilitates retraction of the retractable needle when engaged with the unitary plunger seal. Dual locking systems prevent re-use of the syringe after needle retraction.

Claims

1. A retractable syringe that comprises a barrel, a retractable needle, a plunger axially moveable in said barrel and comprising a plunger rod capable of engaging said retractable needle, a plunger outer, a controlling member and a biasing member, wherein the plunger rod, plunger outer and the controlling member co-operate to releasably maintain said biasing member in an initially energized state, wherein release of said biasing member from said initially energized state facilitates retraction of said plunger rod when engaged with said retractable needle and wherein said controlling member comprises one end operable by a user to control the rate of retraction and another end connected to said plunger rod.

2. The syringe of claim 1, wherein the plunger rod comprises a unitary seal capable of engaging said retractable needle.

3. The syringe of claim 1, wherein, said controlling member comprises one or more mating portions that initially engage said plunger outer to facilitate maintaining said biasing member in an initially energized state.

4. The syringe of claim 3, wherein the one or more mating portions comprise one or more notches, cutaways or recesses.

5. The syringe of claim 1, wherein the biasing member is a spring.

6. The syringe of claim 1, wherein the plunger rod and controlling member are releasably connected.

7. The syringe of claim 6, wherein the plunger rod and the controlling member are frangibly connected.

8. The syringe of claim 1, further comprising a locking system comprising elements of the plunger outer and the plunger rod.

9. A retractable syringe comprising a barrel, a retractable needle and a plunger according to claim 1, which plunger is engageable with said retractable needle to facilitate retraction thereof after delivery of fluid contents of said syringe.

10. The retractable syringe of claim 9, further comprising a locking system comprising elements of the barrel and the plunger outer.

11. A retractable syringe according to claim 9 wherein the barrel is formed of glass.

12. The retractable syringe of claim 9 which is a prefilled syringe.

13. The retractable syringe of claim 12, which is prefilled with an injectable solution of a low molecular weight heparin.

14. The retractable syringe of claim 13, wherein the low molecular weight heparin is enoxaparin sodium.

15. The plunger of claim 1, wherein the controlling member and the plunger housing are releasably connected, whereby disengagement of the controlling member and the plunger housing facilitate release of said biasing member from said initially energized state.

16. A retractable syringe comprising a barrel, a plunger that is axially moveable in said barrel and a releasable needle retaining system mounted to the barrel, said releasable needle retaining system comprising:

a retractable needle that comprises a needle body having a base that is engageable by the plunger to facilitate retraction of the retractable needle;

a needle seal that releasably engages the base until engagement of the base by the plunger; and

a retaining member that comprises a mating surface complementary to a mating surface of an interior wall of said barrel, said retaining member releasably engaging said retractable needle to initially retain said retractable needle at a needle end of said barrel until said retractable needle is engaged by the plunger to facilitate retraction of said retractable needle;

wherein said plunger comprises a plunger rod capable of engaging said base of said needle body;

a plunger outer;

a controlling member; and

a biasing member, wherein the plunger rod, plunger outer and the controlling member co-operate to releasably maintain said biasing member in an initially energized state, wherein release of said biasing member from said initially energized state facilitates retraction of said plunger rod when engaged with said retractable needle and wherein said controlling member comprises one end operable by a user to control the rate of retraction and another end connected to said plunger rod.

17. A prefilled retractable syringe comprising:

a glass barrel that comprises an interior wall and a collar having a releasing ring;

a releasable needle retaining system that comprises;

a needle assembly that comprises a retractable needle and a needle seal;

a retaining member that comprises a mating surface complementary to a mating surface of said interior wall, said retaining member releasably engaging said retractable needle to initially retain said retractable needle at a needle end of said barrel; and

an ejector member for releasing the retractable needle from the retaining member;

a plunger engageable with said retractable needle and axially moveable within said barrel, said plunger comprising, a plunger outer, a plunger rod frangibly connected to a controlling member comprising one or more mating portions, a spring and a unitary plunger seal capable of engaging said retractable needle, wherein the plunger rod, plunger outer and the controlling member cooperate to releasably maintain said spring in an initially compressed state, said one or more mating portions of said controlling member engaging said plunger outer until said releasing ring disengages said one or more mating portions from said plunger outer at the end of depression of said plunger to facilitate decompression of said spring and retraction of said retractable needle when engaged with said unitary plunger seal, wherein said controlling member comprises one end operable by a user to control the rate of retraction and another end connected to said plunger rod; and

locking systems respectively formed between;

elements of the plunger outer and the collar; and

elements of said plunger rod and said plunger outer;

to prevent re-use of the syringe after needle retraction.

18. A method of assembling a retractable syringe comprising:

(i) mounting a releasable needle retaining system inside a syringe barrel, said releasable needle retaining system comprising;

a retractable needle; and

a retaining member that comprises a mating surface complementary to a mating surface of an interior wall of said barrel, said retaining member releasably engaging said retractable needle to initially retaining said retractable needle at a needle end of said barrel until said retractable needle is engaged by a plunger to facilitate retraction of said retractable needle; and

(ii) inserting a plunger comprising a plunger rod, a plunger outer, a controlling member and a biasing member into said barrel to be axially moveable in said barrel, wherein the plunger rod, plunger outer and the controlling member co-operate to releasably maintain said biasing member in an initially energized state, wherein said controlling member comprises one end operable by a user to control the rate of retraction and another end connected to said plunger rod.

19. The method of claim 18, wherein the retractable syringe is prefilled with fluid contents prior to step (ii).

20. The method of claim 19, wherein a plunger seal is fitted into the barrel after the retractable syringe is prefilled with fluid contents and prior to step (ii).

21. The method of claim 20, wherein the plunger is fitted to the plunger seal.