Injector and method of assembly

Patent metadata

Field	Value
Publication number	US-2016296704-A1
Application number	US-201414916208-A
Country	US
Kind code	A1
Filing date	Oct 22, 2014
Priority date	Oct 24, 2013
Publication date	Oct 13, 2016
Grant date	—

Abstract

An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a medical fluid or 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. The sterile container needle is attached to a connector, the connector mechanically coupled to the container to secure the sterile container needle to the container with the needle in the 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

1 . An injector comprising:
a container including a container wall with an interior surface; a seal assembly including a flexible seal assembly wall with an interior surface, the interior surfaces of the container wall and the seal assembly wall defining a closed sterile reservoir filled with a medical fluid or drug product, and a barrier disposed exterior of the seal assembly wall to define an enclosed space between the flexible wall and the barrier; a fluid delivery system comprising a sterile container needle having a point disposed only through the barrier in a storage state, and disposed through the flexible wall into the sterile reservoir in a delivery state, the sterile container needle attached to a connector, the connector mechanically coupled to the container to secure the sterile container needle to the container with the needle in the storage state; and an actuator that is adapted to move the container needle from the storage state to the delivery state.

2 . The injector of claim 1 , wherein the connector is press fit onto the container.

3 . The injector of claim 1 , wherein the connector is a first connector of a pair of connectors, a second connector of the pair of connectors being attached to the container, the first and second of the pair of connectors mechanically coupled to secure the sterile container needle to the container in the storage state.

4 . The injector of claim 3 , wherein the first and second connectors each comprise one of a pair of facing surfaces, the facing surfaces abutting to limit movement of the first and second connectors axially along a longitudinal axis of the sterile container needle.

5 . The injector of claim 3 , wherein the first and second connectors engage to rotatably couple the pair of connectors to secure the sterile container needle to the container in the storage state.

6 . The injector of claim 3 , wherein the first and second connectors threadingly engage to couple the pair of connectors to secure the sterile container needle to the container in the storage state.

7 . The injector of claim 3 , wherein the container comprises a rim disposed about an opening, the seal assembly being disposed over the opening in the container, and the second connector comprising a rim and disposed over the seal assembly, the container further comprising a crimp ring formed about the rim of the container and the rim of the second connector with the seal assembly disposed between the rims to secure the seal assembly between the rim of the container and the rim of the second connector.

8 . The injector of claim 7 , wherein the second connector has a passage therethrough, the sterile container needle disposed through the passage in the second connector and through the barrier in the storage state.

9 . The injector of claim 3 , wherein the first connector comprises a collar disposed continuously about the sterile connector needle.

10 . The injector of claim 3 , wherein the first connector comprises a collar disposed discontinuously about the sterile connector needle.

11 . The injector of claim 1 , wherein the wall of the container comprises a rigid wall.

12 . The injector of claim 1 , wherein the wall of the container defines a bore, and the container further comprises a stopper that is moveable along the bore.

13 . The injector of claim 1 , wherein the container wall defines a bore with an opening in fluid communication with a first end of the bore, and the flexible wall defines a septum disposed across the opening and fixedly attached to the container wall.

14 . The injector of claim 1 , wherein the fluid delivery system comprises sterile flexible tubing connected at a first end to the container needle and a second end to a sterile injection needle received within a sterile cover that closes off the sterile injection needle.

15 . The injector of claim 1 , wherein the actuator is adapted to delay movement of the container needle from the storage state to the delivery state after an input is received.

16 . The injector of claim 15 , further comprising a mechanical, electro-mechanical, or electrical input device coupled to the actuator.

17 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of an erythropoiesis stimulating agent.

18 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of a granulocyte colony-stimulating factor.

19 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of a TNF blocker.

20 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of a pegylated granulocyte colony-stimulating factor.

21 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of interleukin-receptor specific antibody.

22 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of IGF-receptor (Insulin Growth Factor receptor) specific antibody.

23 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of TGF-specific antibody.

24 . The injector of claim 1 , wherein the medical fluid or drug product comprises a volume of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)-specific antibody.

25 . A method of assembling an injector, the method comprising:
filling a sterile reservoir of a container with a medical fluid or drug product under sterile conditions, the reservoir defined by an interior surface of a wall of the container; mechanically coupling a sterile fluid delivery system to the container under sterile conditions, the fluid delivery system not in fluid communication with the reservoir in a storage state and in fluid communication with the reservoir in a delivery state; and assembling the remainder of the injector under clean room conditions.

26 . The method of claim 25 , wherein the step of filling the sterile reservoir follows the step of mechanically coupling the sterile fluid delivery system to the container.

27 . The method of claim 25 , wherein the step of mechanically coupling the sterile fluid delivery system to the container follows the step of filling the sterile reservoir.

28 . The method of claim 25 , wherein the step of mechanically coupling the sterile fluid delivery system occurs within a fill/finish suite.

29 . The method of claim 25 , wherein assembling the remainder of the injector comprises:
attaching the fluid delivery system to an actuator under clean room conditions, the actuator adapted to change the state of the fluid delivery system from the storage state to a delivery state.

30 . A subassembly comprising:
a container including a container wall with an interior surface; a seal assembly including a flexible seal assembly wall with an interior surface, the interior surfaces of the container wall and the seal assembly wall defining a closed sterile reservoir filled with a medical fluid or drug product, and a barrier disposed exterior of the seal assembly wall to define an enclosed space between the flexible wall and the barrier; and a fluid delivery system comprising a sterile container needle having a point disposed only through the barrier in a storage state, and disposed through the flexible wall into the sterile reservoir in a delivery state, the sterile container needle attach

Assignees

• Amgen Inc

Inventors

• Gibson Scott R

Classifications

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title

• A61M5/1782

  Devices aiding filling of syringes in situ (combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003) · CPC title

• A61M5/288 Primary

  by piercing without internal pressure increase (A61M5/283 takes precedence) · CPC title

• A61M5/2466 Primary

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

• A61M2202/04

  Liquids · CPC title