Systems and approaches for sterilizing a drug delivery device

Patent metadata

Field	Value
Publication number	US-11565006-B2
Application number	US-202016950312-A
Country	US
Kind code	B2
Filing date	Nov 17, 2020
Priority date	Nov 3, 2017
Publication date	Jan 31, 2023
Grant date	Jan 31, 2023

Abstract

An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.

First claim

What is claimed is:

1. An on-body injector system comprising:
a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container, the container having an opening and the seal member at least partially covering the opening in the container, and the sealing interface configured to be sterilized and/or disinfected by rays of radiation emitted by a radiation generator;
a fluid pathway assembly coupled to the drug container assembly and including a needle, the needle being movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member; and
a barrier disposed adjacent to the sealing interface and having an opening;
wherein at least a portion of the drug container assembly is positioned adjacent to the opening in the barrier;
wherein an end of the fluid pathway assembly is connected to the container of the drug container assembly.

2. The on-body injector system of claim 1 , wherein the barrier includes a wall and the opening is formed in the wall.

3. The on-body injector system of claim 2 , wherein at least a portion of the container and the radiation generator are disposed on opposite sides of the wall.

4. The on-body injector system of claim 3 , wherein the at least a portion of the seal member and the radiation generator are disposed on the same side of the wall.

5. The on-body injector system of claim 3 , wherein the barrier includes a bore communicating with the opening, and wherein the at least a portion of the seal member is disposed in the bore.

6. The on-body injector system of claim 5 , wherein the at least a portion of the container is disposed outside of the bore.

7. The on-body injector system of claim 1 , wherein the opening in the container is coaxial with the opening in the barrier.

8. The on-body injector system of claim 1 , wherein the drug container assembly includes a crimp ring coupling the seal member to the container, at least a portion of the crimp ring extending through the opening in the barrier.

9. The on-body injector system of claim 1 , wherein the radiation generator is a photon generator.

10. The on-body injector system of claim 9 , wherein the radiation generator is an electron beam generator.

11. The on-body injector system of claim 1 , wherein the barrier is a radiation shield.

12. The on-body injector system of claim 1 , wherein the rays of radiation emitted by the radiation generator penetrate the seal member to sterilize or disinfect the sealing interface between the seal member and the container.

13. The on-body injector system of claim 1 , wherein the barrier limits exposure of at least a portion of the container to the rays of radiation emitted by the radiation generator during a sterilization or disinfection process.

14. The on-body injector system of claim 13 , wherein the barrier includes a shoulder configured to obstruct the rays of radiation emitted by the radiation generator from interacting with the at least a portion of the container during the sterilization or disinfection process.

15. The on-body injector system of claim 1 , wherein the barrier surrounds at least a portion of the seal interface.

16. The on-body injector system of claim 1 , wherein:
the seal member includes a first surface and a second surface located on opposite sides of the seal member;
the first surface of the seal member and a wall of the container define a reservoir; and
in the storage position, the point of the needle is disposed adjacent to the second surface of the seal member with no structure in between the second surface of the seal member and the point of the needle.

Assignees

• Amgen Inc

Inventors

• Barbedette Loic
• Devitt Shaun
• Mismar Wael

Classifications

• A61M5/002

  Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics (needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001) · CPC title

• B65B3/003

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

• A61L2/081

  Gamma radiation · CPC title

• A61L2/26

  Accessories · CPC title

• G21F1/02

  Selection of uniform shielding materials · CPC title