NZ799577B2

NZ799577B2 - Auto-injector

Info

Publication number: NZ799577B2
Application number: NZ799577A
Authority: NZ
Inventors: Rachel Arnott; Scott Barton; Bart E Burgess; Richard Gildersleeve; Alexei Goraltchouk; Bryan C Grygus; Daniel Halbig; Christopher Kanel; Trevor Langley; Alfred Marino
Original assignee: Regeneron Pharmaceuticals Inc
Filing date: 2018-05-04
Publication date: 2025-12-02

Abstract

injection device includes a housing with an opening, a shield covering the opening, a medicament container disposed within the housing, and a fluid conduit having a moveable piercing end. The moveable piercing end has a first configuration where the fluid conduit is entirely contained within the housing, a second configuration where the moveable piercing end of the fluid conduit extends through the opening and outside of the housing, and a third configuration where the moveable piercing end is retracted within the housing. The shield includes a material permeable to a gaseous sterilant, and is configured to be removed from the housing prior to operation of the injector. The shield of the current invention helps maintain sterility of the fluid conduit yet is also easily removable and sanitizable.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

1. An injector, comprising: a housing including an opening; a medicament container disposed within the housing; a fluid conduit having a moveable piercing end, the moveable piercing end having a first configuration where the fluid conduit is ly contained within the housing, a second configuration where the moveable piercing end of the fluid conduit extends through the opening and outside of the housing, and a third configuration where the le piercing end is retracted within the housing; and a shield covering the g, wherein the shield includes a material permeable to a gaseous sterilant, and wherein the shield is configured to be removed from the housing prior to operation of the injector.

2. The injector of claim 1, further including a seal coupled to a first end of the medicament ner, n the seal is not permeable to the gaseous sterilant.

3. The or of any one of claims 1-2, further ing a plug, adjacent to the seal, that is permeable to the gaseous sterilant.

4. The or of any one of claims 1-3, wherein the fluid conduit includes a container end configured to move between a first position that is not in fluid communication with the container; and a second position that is in fluid communication with the container.

5. The injector of claim 4, wherein, in the first position, the container end of the fluid conduit is disposed in the plug.

6. The or of claim 5, wherein, after exposure to gaseous sterilant externally of the housing and while the shield is coupled to the housing, the container end of the fluid t, disposed in the plug, is configured to remain sterile within the housing.

7. The injector of any one of claims 3-6, wherein the plug includes a rubber that is permeable to the gaseous sterilant.

8. The injector of any one of claims 3-7, wherein the plug includes one or more of ne, ethylene propylene diene monomer (M-class) rubber (EPDM), or styrene-butadiene.

9. The or of any one of the preceding claims, wherein gaseous sterilant disposed externally of the housing is configured to enter the housing through the shield.

10. The injector of any one of the ing claims, wherein the material is not permeable to liquid.

11. The injector of any one of the preceding , wherein the material includes a polymer fiber membrane.

12. The injector of any one of the preceding claims, wherein the al includes a polyethylene fiber membrane.

13. The injector of any one of the ing , wherein the al includes a second plug permeable to the sterilant.

14. The injector of claim 13, n the second plug includes rubber.

15. The injector of claim 13, wherein the second plug includes one or more of isoprene, ethylene propylene diene r (M-class) rubber (EPDM), styrenebutadiene , or thermoplastic elastomers (TPE).

16. The injector of any one of the preceding claims, wherein the material is permeable to ne oxide or vaporized hydrogen peroxide.

17. The injector of any one of the preceding claims, wherein the injector is configured to permit sterilization of the fluid conduit by gaseous sterilant initially disposed externally of the housing while: (i) the moveable piercing end is in the first configuration and the fluid conduit is entirely contained within the housing; (ii) the medicament container is disposed within the housing; and (iii) an interior volume of the fluid conduit is sealed from any liquid disposed externally of the housing.

18. The injector of any one of the preceding claims, wherein a portion of an interior of the housing is configured to be exposed to contaminants after exposure of the injector to the gaseous sterilant.

19. The injector of claim 4 or claim 5, further comprising: a seal coupled to the medicament container, n the seal is not permeable to the gaseous sterilant; and a plug adjacent to the seal that is permeable to the gaseous sterilant, n, while in the first position, a container end of the fluid conduit is disposed in the plug and is not in fluid communication with the medicament container.

20. The or of claim 19, n the container end of the fluid conduit is movable through the plug and the seal from a first position into a second on, and wherein the container end is in fluid communication with the medicament container while in the second position.

21. The injector of claim 19, wherein the material is not permeable to liquid.

22. A method of sterilizing the or of claim 1, the method comprising: exposing the injector to a sterilant externally of the housing of the injector to sterilize at least a portion of the fluid conduit entirely enclosed within the housing of the injector while the fluid t is in the first configuration and while the medicament container is entirely enclosed within the housing of the injector.

23. The method of claim 22, wherein, while the injector is exposed to the sterilant, the or is in an assembled configuration, wherein in the assembled uration, the injector is configured to be activated to cause the moveable piercing end of the fluid conduit to extend through the housing to outside of the housing, and deliver medicament through the fluid conduit.

24. The injector of claim 1, further sing: an audio emitting device ed by the housing; and a plurality of lights coupled to the housing, wherein the plurality of lights are configured to illuminate upon completion of an injection sequence; and wherein the audio emitting device is ured to emit audio indicative of a beginning of an injection sequence.

25. The injector of any one of claims 1-18 or 21, r comprising: a packaging covering or enclosing at least a portion of the housing, wherein the shield is configured to be removed from the injector upon removal of the packaging from the housing.

26. The injector of any one of claims 1, 22, 23, or 24, further comprising: a seal d to a first end of the medicament container, wherein the seal is not permeable to the gaseous sterilant; and a plug adjacent to the seal that is permeable to the gaseous sterilant, wherein, while in a first position, a container end of the fluid conduit is disposed within the plug and is not in fluid ication with the medicament container, wherein the shield is further configured to seal the moveable piercing end such that the gaseous sterilant is permitted to flow through the fluid conduit between the moveable ng end and the container end and the fluid conduit is thereafter maintained in a sterile condition. SUBSTITUTE SHEET (RULE 26) SUBSTITUTE SHEET (RULE 26) SUBSTITUTE SHEET (RULE 26) SUBSTITUTE SHEET (RULE 26) atian “$355 ‘ E Tauch g Sensar SUBSTITUTE SHEET (RULE 26) ‘ESGZ SUBSTITUTE SHEET (RULE 26) SUBSTITUTE SHEET (RULE 26) SUBSTITUTE SHEET (RULE 26) SUBSTITUTE SHEET (RULE 26)