Injector and method of assembly

Patent metadata

Field	Value
Publication number	US-11759571-B2
Application number	US-202017072618-A
Country	US
Kind code	B2
Filing date	Oct 16, 2020
Priority date	Mar 22, 2013
Publication date	Sep 19, 2023
Grant date	Sep 19, 2023

Abstract

An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a sterile container needle that is in fluid communication with the container in a delivery state, but may or may not be in fluid communication with the container in a storage state. Further, the injector may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

First claim

I claim:

1. A method of assembling an injector, the method comprising:
providing a container including a wall having an interior surface and a seal assembly having a septum including an interior surface and an exterior surface, the wall and the interior surface of the septum at least partially defining a reservoir;
providing a fluid delivery system;
providing an injection member configured to be connected in fluid communication with the reservoir via the fluid delivery system;
sterilizing the container while the container and the fluid delivery system are separate from each other, wherein the container is sterilized in a first assembly space;
after sterilizing the container, attaching the fluid delivery system to the container in a second assembly space such that the fluid delivery system is in a storage state and the exterior surface of the septum is free from direct contact with any component of the injector, wherein the first assembly space has a higher level of freedom from contamination than the second assembly space; and
coupling the fluid delivery system to an actuator, the actuator configured to actuate the fluid delivery system to establish fluid communication between the injection member and the reservoir.

2. The method of assembling an injector of claim 1 , wherein coupling the fluid delivery system to an actuator comprises coupling the fluid delivery system to an actuator after the fluid delivery system is attached to the container.

3. The method of assembling an injector of claim 1 , wherein
the fluid delivery system comprises a container needle having a point, and
the injection member is configured to be connected in fluid communication with the reservoir via the container needle.

4. The method of assembling an injector of claim 3 , comprising,
after sterilizing the container, attaching the fluid delivery system to the container in the second assembly space such that the point of the container needle is aligned to penetrate the seal assembly or partially penetrates the seal assembly to define the storage state, and
attaching the container needle to the actuator, the actuator adapted to move the container needle from the storage state to a delivery state wherein the container needle is disposed through the seal assembly into the reservoir.

5. The method of assembling an injector of claim 3 , wherein the fluid delivery system comprises at least one flexible tubing configured to provide fluid communication between the container needle and the injection member during use of the injector.

6. The method of assembling an injector of claim 4 , the actuator being configured to (a) automatically move the container needle from the storage state to the delivery state, or (b) automatically move the container needle from the storage state to the delivery state in response to a signal received from an input device.

7. The method of assembling an injector of claim 3 , comprising sterilizing, while in the second assembly space, a surface of the seal assembly to be penetrated by the point of the container needle prior to attaching the fluid delivery system to the container.

8. The method of assembling an injector of claim 1 , wherein the wall of the container defines a bore having a first end and a second end, an opening is formed in the wall of the container at the first end of the bore, the seal assembly is disposed across the opening and fixedly attached to the wall of the container, and the container includes a stopper that is disposed within the second end of the bore and is moveable along the bore.

9. The method of assembling an injector of claim 4 , wherein the seal assembly comprises a second wall disposed exterior to the septum wall to define an enclosed space between the septum and the second wall, and the point of the container needle is disposed through the second wall into the enclosed space in the storage state.

10. The method of assembling an injector of claim 9 , wherein the point of the container needle is aligned to penetrate the septum in the storage state.

11. The method of assembling an injector of claim 9 , wherein the wall of the container defines a bore having a first end and a second end, an opening is formed in the wall of the container at the first end of the bore, the septum of the seal assembly is disposed across the opening and fixedly attached to the wall of the container, and the container includes a stopper that is disposed within a second end of the bore and is moveable along the bore.

12. The method of assembling an injector of claim 4 , wherein the container needle has the point disposed only partially through the seal assembly in the storage state and disposed through the interior surface of the seal assembly into the reservoir in the delivery state.

13. The method of assembling an injector of claim 12 , wherein the wall of the container defines a bore having a first end and a second end, an opening is formed in the wall of the container at the first end of the bore, the seal assembly is disposed across the opening and fixedly attached to the wall of the container, and the container includes a stopper that is disposed within the second end of the bore and is moveable along the bore.

14. The method of assembling an injector of claim 1 , the first assembly space being operated under sterile conditions.

15. The method of assembling an injector of claim 4 , the first assembly space being operated under sterile conditions.

16. The method of assembling an injector of claim 4 , comprising sterilizing, while in the second assembly space, a surface of the seal assembly to be penetrated by the point of the container needle prior to attaching the fluid delivery system to the container.

17. The method of assembling an injector of claim 3 , the container needle and the injection needle being separate needles.

18. The method of assembling an injector of claim 4 , the container needle and the injection needle being separate needles.

19. The method of assembling an injector of claim 9 , the container needle and the injection needle being separate needles.

20. The method of assembling an injector of claim 12 , the container needle and the injection needle being separate needles.

Assignees

• Amgen Inc

Inventors

• Gibson Scott R

Classifications

• A61M5/2466 Primary

  by piercing without internal pressure increase (A61M5/2429 takes precedence) · CPC title

• B65B3/003

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• A61M2005/247

  with fixed or steady piercing means, e.g. piercing under movement of ampoule · CPC title

• A61M2005/2474

  with movable piercing means, e.g. ampoule remains fixed or steady · CPC title

• A61M5/3202

  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 title