Aseptic piercing system and method

• US 10,182,969 B2
• Filed: 03/10/2016
• Issued: 01/22/2019
• Est. Priority Date: 03/10/2015
• Status: Active Grant

• Current Assignee: Regeneron Pharmaceuticals Incorporated
• Original Assignee: Regeneron Pharmaceuticals Incorporated
• Inventors: Arnott, Rachel Paige, Burgess, Bart E., Cupicha, Michael, Goraltchouk, Alexei, Grygus, Bryan, Stelmah, Mike
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/066,791
• Publication Number:
  US 20160262984A1
• Time in Patent Office: 1,048 Days
• Field of Search: 604403-414
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1443 Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 2005/2474 with movable piercing means, e.g. ampoule remains fixed or steady
• CPC Class Codes: A61M 2005/3118 via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence

Abstract

The present disclosure provides aseptic vial piercing and sterilization systems, and methods of assembling, using and sterilizing same. The systems and methods utilize a pre-sterilized primary container including a first end, a first cavity, a second end with an opening in communication with the first cavity, a septum at least partially sealing the opening, and a product within the first cavity. The systems and methods include an injection assembly including a first end portion of a hollow flowpath forming member. The injection assembly and the primary container may be assembled in a non-sterile environment to form a second cavity extending about the first end portion of the flowpath forming member and to the primary container. The second cavity may then be selectively sterilized in a non-deleterious manner to the product to allow the first end portion to aseptically pierce the septum to extend into the first cavity.

Claims

1. An injection device, comprising:

a container enclosing a fluid, the container having a first end and a second end;

a conduit movable between a retracted configuration and a deployed configuration, wherein the conduit is not in fluid communication with the fluid enclosed in the container while in the retracted configuration, and is in fluid communication with the fluid enclosed in the container and configured to deliver the fluid from the container to a patient when in the deployed configuration;

a piston configured to move from the first end of the container toward the second end of the container;

a drive member configured to drive the piston; and

a lock configured to maintain the conduit in the retracted configuration, wherein an application of a force from the drive member to the piston is configured to move the lock and allow the conduit to move into fluid communication with the fluid enclosed in the container.

2. The injection device of claim 1, further including a seal enclosing an opening at the second end of the container.

3. The injection device of claim 2, wherein a portion of the seal directly contacts the fluid enclosed by the container and, in the retracted configuration, a piercing end of the conduit is enclosed by the seal.

4. The injection device of claim 3, wherein, while the conduit is in the deployed configuration, the only portion of the conduit extending into the container includes a portion of the piercing end that was previously enclosed by the seal while the conduit was in the retracted configuration.

5. The injection device of claim 3, wherein, while the conduit is in the retracted configuration, the piercing end of the conduit is configured to be sterilized while being enclosed by the seal.

6. The injection device of claim 3, wherein, during a transition from the retracted configuration to the deployed configuration, the piercing end of the conduit extends through the end of the seal that directly contacts the fluid enclosed by the container.

7. The injection device of claim 1, further including:

an expandable element having a compressed configuration and an expanded configuration, wherein the expandable element is in the compressed configuration when the conduit is in the retracted configuration, wherein the lock is configured to maintain the expandable element in the compressed configuration while the lock is in a first position, and, when the lock is moved radially outward from the first position, the expandable element is configured to move from the compressed configuration to the expanded configuration.

8. The injection device of claim 7, wherein movement of the expandable element from the compressed configuration to the expanded configuration moves the conduit toward the first end of the container, through the seal, and into fluid communication with the fluid enclosed in the container.

9. The injection device of claim 7, wherein the movement of the expandable element from the compressed configuration to the expanded configuration moves the conduit toward the first end of the container at a speed of at least 10 mm/second.

10. The injection device of claim 7, wherein the expandable element is a spring.

11. The injection device of claim 7, wherein, while the conduit is in the retracted configuration, the conduit is fixed relative to a reference location, and the container is movable relative to the conduit and to the reference location.

12. The injection device of claim 11, wherein after the lock is moved radially outward from the first position, the conduit moves relative to the reference location, and the container is fixed relative to the reference location.

13. The injection device of claim 1, wherein, while the conduit is in the retracted configuration, application of force on the piston along a vector extending from the first end of the container toward the second end of the container moves the container along the vector.

14. The injection device of claim 13, wherein, after the conduit is in the deployed configuration, application of force on the piston along the vector urges the fluid in the container through the conduit.

15. The injection device of claim 1, wherein the piston is configured to seal the first end of the container.

16. An injection device, comprising:

a container configured to enclose a fluid, the container having a first end, a second end, and a movable piston disposed therein;

a conduit movable between a retracted configuration and a deployed configuration;

a drive member configured to drive the piston;

an expandable element having a compressed configuration and an expanded configuration, the expandable element being coupled to the conduit, wherein the expandable element is in the compressed configuration when the conduit is in the retracted configuration; and

a lock configured to maintain the expandable element in the compressed configuration while the lock is in a first position, wherein an application of a force from the drive member to the piston is configured to move the lock from the first position, allowing the expandable element to move from the compressed configuration to the expanded configuration and drive the conduit into fluid communication with the fluid enclosed in the container.

17. The injection device of claim 16, wherein the lock prevents expansion of the expandable element while in the first position by impeding a pathway of the expandable element, and an application of force from the drive member moves the lock radially outward from the first position and out of the pathway.

18. The injection device of claim 16, wherein movement of the expandable element from the compressed configuration to the expanded configuration moves the conduit toward the first end of the container at a speed of at least 10 mm/second.

19. An injection device, comprising:

a container configured to enclose a fluid, the container having a first end and a second end;

a seal enclosing an opening at the second end of the container;

a conduit movable between a retracted configuration and a deployed configuration;

an expandable element having a compressed configuration and an expanded configuration, the expandable element being coupled to the conduit, wherein the expandable element is in the compressed configuration when the conduit is in the retracted configuration, and movement of the expandable element from the compressed configuration to the expanded configuration drives the conduit through the seal into the deployed configuration; and

a piston configured to move from the first end of the container toward the second end of the container; and

a drive member configured to drive the piston.

20. The injection device of claim 19, further including a lock configured to maintain the expandable element in the compressed configuration while the lock is in a first position, wherein an application of a force from the drive member to the piston is configured to move the lock from the first position, allowing the expandable element to move from the compressed configuration to the expanded configuration.

21. The injection device of claim 20, wherein the lock prevents expansion of the expandable element while in the first position by impeding a pathway of the expandable element, and the application of force from the drive member moves the lock radially outward from the first position and out of the pathway.

22. The injection device of claim 19, wherein the expandable element is a spring.