Injector and method of assembly
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.
1. 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 flexible seal assembly wall defining a closed sterile reservoir filled with a medical fluid or drug product, and a barrier disposed exterior of the flexible seal assembly wall to define an enclosed space between the flexible seal assembly wall and the barrier;
a fluid delivery system comprising a sterile container needle having a point disposed through the barrier and not through the flexible seal assembly wall in a storage state, and the point disposed through the flexible seal assembly wall into the sterile reservoir in a delivery state, wherein the barrier and flexible seal assembly wall define the enclosed space in both the storage state and the delivery state;
a first connector attached to the sterile container needle; and
a second connector, separate from and coupled with the container, the first connector and the second connector being mechanically coupled to secure the sterile container needle to the container with the sterile container needle in the storage state;
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.
2. The subassembly of claim 1 , 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.
3. The subassembly of claim 1 , 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.
4. The subassembly 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.
5. The subassembly 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.
6. The subassembly of claim 1 , wherein the first connector comprises a collar disposed continuously about the sterile container needle.
7. The subassembly of claim 1 , wherein the first connector comprises a collar disposed discontinuously about the sterile container needle.
8. The subassembly of claim 1 , wherein the wall of the container comprises a rigid wall.
9. The subassembly 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.
10. The subassembly of claim 1 , wherein the container wall defines a bore and an opening in fluid communication with a first end of the bore, and the flexible seal assembly wall defines a septum, the flexible seal assembly wall disposed across the opening and fixedly attached to the container wall.
11. The subassembly of claim 1 , wherein the fluid delivery system comprises sterile flexible tubing connected at a first end to the sterile container needle and a second end to a sterile injection needle received within a sterile cover that closes off the sterile injection needle.
12. The subassembly of claim 1 , further comprising an actuator that is adapted to move the sterile container needle from the storage state to the delivery state.
13. The subassembly of claim 12 , wherein the actuator is adapted to delay movement of the sterile container needle from the storage state to the delivery state after an input is received.
14. The subassembly of claim 12 , further comprising a mechanical, electro-mechanical, or electrical input device coupled to the actuator.
15. The subassembly of claim 1 , wherein the medical fluid or drug product comprises at least one of (a) a volume of an erythropoiesis stimulating agent, (b) a volume of a granulocyte colony-stimulating factor, (c) a volume of a TNF blocker, (d) a volume of a pegylated granulocyte colony-stimulating factor, (e) a volume of interleukin-receptor specific antibody, (f) a volume of IGF-receptor (Insulin Growth Factor receptor) specific antibody, (g) a volume of TGF-specific antibody, (h) a volume of PCSK 9 (Proprotein Convertase Subtilisin/Kexin Type 9)—specific antibody.