US-20260124115-A1 - ASEPTIC PIERCING SYSTEM AND METHOD

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.

Inventors

• Rachel Paige Arnott
• Bart E. BURGESS
• Michael J. CUPICHA
• Alexei Goraltchouk
• Bryan C. GRYGUS
• Mike Stelmah

Assignees

• REGENERON PHARMACEUTICALS, INC.

Dates

Publication Date

20260507

Application Date

20251229

Claims (20)

1. 1 - 22 . (canceled)
2. 23 . A device, comprising: a container having a first end and a second end; a driver member movable between a retracted configuration and a deployed configuration; a piston configured to move from the first end of the container toward the second end of the container; a translation mechanism configured to drive the piston; and a lock configured to maintain the driver member in the retracted configuration, wherein an application of a force from the translation mechanism to the piston is configured to move the lock and allow the driver member to move to the deployed configuration.
3. 24 . The device of claim 23 , wherein the driver member moves toward the second end of the container upon movement from the retracted configuration to the deployed configuration.
4. 25 . The device of claim 23 , further comprising: a collar coupled to the second end of the container, wherein the collar includes a distal axial edge, and wherein the distal axial edge of the collar is configured to engage the lock.
5. 26 . The device of claim 23 , further comprising a collar coupled to the second end of the container, wherein: the collar includes a distal axial edge; the distal axial edge of the collar is configured to engage the lock; and the lock and the collar are slidable relative to one another.
6. 27 . The device of claim 23 , further comprising a collar coupled to the second end of the container, wherein: the collar includes a distal axial edge; the distal axial edge of the collar is configured to engage the lock; and the lock comprises a retainer member slidable relative to the collar; the retainer member includes a radially-or laterally-inwardly extending cam, latch, or actuation portion; and the distal axial edge of the collar is configured to engage the radially-or laterally-inwardly extending cam, latch, or actuation portion.
7. 28 . The device of claim 23 , further comprising a seal enclosing an opening at the second end of the container.
8. 29 . A device, comprising: a container configured to enclose a fluid, the container having a first end, a second end, and a piston disposed therein; a driver member movable between a retracted configuration and a deployed configuration; a translation mechanism configured to drive the piston; an expandable element having a compressed configuration and an expanded configuration, the expandable element being coupled to the driver member, wherein the expandable element is in the compressed configuration when the driver member 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 translation mechanism 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 driver member into the deployed configuration.
9. 30 . The device of claim 29 , wherein the lock prevents expansion of the expandable element while in the first position by impeding a pathway of the driver member, and the application of the force from the translation mechanism to the piston is configured to move the lock radially outward from the first position and out of the pathway.
10. 31 . The device of claim 29 , wherein the lock includes: a collar coupled to the second end of the container, wherein the collar includes a distal axial edge; and a retainer member slidable relative to the collar, wherein the retainer member includes a radially-or laterally-inwardly extending cam, latch, or actuation portion, wherein the distal axial edge of the collar is configured to engage the radially-or laterally-inwardly extending cam, latch, or actuation portion; wherein the application of the force from the translation mechanism to the piston is configured to move the cam, latch, or actuation portion radially outward, allowing the expandable element to move from the compressed configuration to the expanded configuration.
11. 32 . The device of claim 29 , wherein the lock extends laterally-inwardly when the driver member is in the retracted configuration.
12. 33 . The device of claim 29 , wherein the application of the force from the translation mechanism to the piston is configured to cause translation of the container toward the driver member; and wherein translation of the container toward the driver member is configured to move the lock from the first position.
13. 34 . The device of claim 29 , further comprising a seal enclosing an opening at the second end of the container.
14. 35 . A device, comprising: a container configured to enclose a fluid, the container having a first end and a second end; a driver member 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 driver member, wherein the expandable element is in the compressed configuration when the driver member 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 movement of the lock from the first position to a second position allows the expandable element to move from the compressed configuration to the expanded configuration and drive the driver member into the deployed configuration.
15. 36 . The device of claim 35 , further comprising: a collar coupled to the second end of the container, wherein the collar includes a distal axial edge, and wherein the distal axial edge of the collar is configured to engage the lock.
16. 37 . The device of claim 35 , further comprising a collar coupled to the second end of the container, wherein: the collar includes a distal axial edge; the distal axial edge of the collar is configured to engage the lock; and translation of the container is configured to cause the distal axial edge of the collar to move the lock from the first position.
17. 38 . The device of claim 35 , further comprising a collar coupled to the second end of the container, wherein: the collar includes a distal axial edge; the distal axial edge of the collar is configured to engage the lock; and translation of the container is configured to cause the distal axial edge of the collar to move the lock radially outwardly from a pathway of the driver member.
18. 39 . The device of claim 35 , wherein the lock includes: a collar coupled to the second end of the container, wherein the collar includes a distal axial edge; and a retainer member slidable relative to the collar, wherein the retainer member includes a radially-or laterally-inwardly extending cam, latch, or actuation portion.
19. 40 . The device of claim 35 , wherein the lock includes: a collar coupled to the second end of the container, wherein the collar includes a distal axial edge; and a retainer member slidable relative to the collar, wherein the retainer member includes a radially-or laterally-inwardly extending cam, latch, or actuation portion, wherein the distal axial edge of the collar is configured to engage the radially-or laterally-inwardly extending cam, latch, or actuation portion.
20. 41 . The device of claim 35 , wherein the lock includes: a collar coupled to the second end of the container, wherein the collar includes a distal axial edge; and a retainer member slidable relative to the collar, wherein the retainer member includes a radially-or laterally-inwardly extending cam, latch, or actuation portion, wherein the distal axial edge of the collar is configured to engage the radially-or laterally-inwardly extending cam, latch, or actuation portion, and wherein translation of the container is configured to move the cam, latch, or actuation portion radially outward, allowing the expandable element to move from the compressed configuration to the expanded configuration.

Description

CROSS REFERENCE TO RELATED APPLICATION This application claims priority benefit under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/130,718, filed Mar. 10, 2015, and entitled Aseptic Piercing System and Method, the entirety of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION The present invention relates generally to delivery systems for administering medication. More specifically, but not exclusively, the present invention concerns aseptic piercing systems. BACKGROUND OF THE INVENTION Currently before a needle is introduced into a vial, primary container or cartridge, it is necessary to use an alcohol wipe to sterilize the face of the vial septum in order to maintain a sterile environment. If sterilization of the vial septum is not properly performed, the medication may be contaminated or contaminants may be delivered to the patient. Further, such wiping is an extra step to perform and it is not practical if the container is inside a delivery device. Typically, wiping the face of the vial septum also adds another step in the sterilization process. Thus, an aseptic piercing system that ensures a sterile environment without the risk of contamination is desirable. SUMMARY OF THE INVENTION Aspects of the present disclosure provide aseptic vial piercing and sterilization systems. The present disclosure also provides methods for assembling, using and sterilizing the aseptic vial piercing systems. In one aspect, the present disclosure provides a method of forming an aseptic primary container piercing mechanism. The method includes obtaining 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 method further includes obtaining an injection assembly including a first end portion of a hollow flowpath forming member. The method also includes assembling the injection assembly with the second end of the primary container 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. Further, the method includes terminally sterilizing the second cavity and the first end portion of the flowpath forming member therein. In some embodiments, the prior to the terminally sterilizing, the second cavity and the first end portion of the flowpath forming member may be non-sterile. In some embodiments, terminally sterilizing the second cavity and the first end portion of the flowpath forming member may include injecting a sterilient through the flowpath forming member and thereby into the second cavity. In some such embodiments, the sterilient may be introduced into the flowpath forming member via a second end portion of the flowpath forming member positioned exterior to the injection assembly. In some other such embodiments, the primary container may include a boot portion that forms the second cavity. In some such embodiments, the boot portion and the septum may be integral. In some other such embodiments, assembling the injection assembly with the second end of the primary container may insert the flowpath forming member through an opening of the boot portion that forms a sliding seal about the flowpath forming member extending therethrough. In some such embodiments, the opening may be configured to vent positive pressure such that the injected sterilient flushes out the atmosphere within the flowpath forming member and the second cavity. In some such embodiments, the method may further include injecting an inert gas through the flowpath forming member and, thereby into the second cavity to flush out the sterilient from the flowpath forming member and the second cavity. In some embodiments, the assembly of the injection assembly and the primary container may be configured such that axial translation of the primary container toward the first end portion of the flowpath forming member effectuates the flowpath forming member being driven through the boot member and the septum such that the flowpath forming member extends through the second cavity and the first end portion is positioned within the first cavity in fluid communication with the product. In some such embodiments, the primary container may be axially translated with respect to the first end portion of the flowpath forming member for a distance to impale the boot member and the septum on the first end portion of the flowpath forming member such that the flowpath forming member extends through the second cavity and the first end portion is positioned within the first cavity in fluid communication with the product. In some other such embodiments, the primary container may be axially translated with respect to the first end portion of the flowpath forming member to such an extent that actuation of the injection assembly is triggered and the injection assembly ther