IP Library › Granted Patent US 12685792
Granted Patent B2
US 12685792 · App. 17/694,457 · Granted Jul 21, 2026

Connection system and active sterilizer for a drug delivery device

Inventors: Zachary Wallace (Philadelphia, PA); Lawton Laurence (Chester Springs, PA); Menaka Abeygunawardena (Blue Bell, PA); Eleftherios Hristofas (Lancaster, PA); John Basista (Ambler, PA)
Assignee: West Pharmaceutical Services, Inc.
A61L2/04A61L2/26A61M5/001A61M5/162A61M5/44A61L2103/15A61L2103/23A61L2202/18A61M39/14
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Quick Facts
Patent No.
US 12685792
App. No.
17/694,457
Granted
Jul 21, 2026
Kind
B2
Abstract

A method for creating an aseptic connection includes arranging a heating element between a first outer sealing surface and a second outer sealing surface such that the heating element is in contact with the first outer sealing surface and the second outer sealing surface. The method further includes applying opposing forces to the first and second outer sealing surfaces such that the first and second outer sealing surfaces are biased towards each other and heating the heating element to sterilize the first outer sealing surface and second outer sealing surface. The method also includes removing the heating element from between the first seal and second seal while continuing to apply the opposing forces to the first and second outer sealing surfaces such that the aseptic connection is simultaneously formed between the first and second outer sealing surfaces.

Claims (31)

1 . A method for creating an aseptic connection within a medical injection device, the medical injection device comprising a housing configured to receive a medicament container that is sealed with a medicament container seal, a transfer needle sealed within the housing via a housing seal, and a connection assembly that is configured to secure the medicament container within the housing such that the medicament container seal opposes the housing seal, the method comprising:

arranging, via the connection assembly, an outer sealing surface of the medicament container seal in an opposing relationship with an outer sealing surface of the housing seal;

arranging a heating element between the outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal such that the heating element is in contact with the outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal;

applying, via the connection assembly and with the heating element between the outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal, force to at least one of the medicament container or the housing such that the outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal are biased towards each other;

sterilizing, concurrently with applying the force, the outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal by heating, with the heating element, the outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal to a predetermined temperature for a predetermined period of time;

removing the heating element from between the medicament container seal and the housing seal while continuing to apply the force such that the aseptic connection is simultaneously formed between the outer sealing surfaces outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal without breaking the medicament container seal or the housing seal; and

fixing, with the connection assembly, the medicament container in a final position that maintains the aseptic connection between the outer sealing surface of the medicament container seal and the outer sealing surface of the housing seal.

2 . The method of claim 1 , wherein the heating element comprises a strip of electrically conductive material.

3 . The method of claim 2 , wherein the heating is produced by electrical resistance.

4 . The method of claim 1 , wherein the heating element comprises a strip of thermally conductive material.

5 . The method of claim 4 , wherein the heating is produced by induction.

6 . The method of claim 1 , further comprising securing the outer sealing surface of the medical container seal in a contacting relationship with the outer sealing surface of the housing seal.

7 . The method of claim 1 , wherein:

applying the force comprises defining a slot between the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal,

the method further comprises securing a first engagement body of the connection assembly and a second engagement body of the connection assembly to each other with the heating element arranged in the slot between the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal, and

removing the heating element further comprises removing the heating element through the slot.

8 . The method of claim 7 , wherein removing of the heating element occurs after the securing the first engagement body and the second engagement body.

9 . The method of claim 1 , wherein the medicament container seal is a septum.

10 . The method of claim 1 , wherein the housing defines an enclosure, a tip of the transfer needle is disposed within the enclosure, and the housing seal seals the enclosure.

11 . The method of claim 1 , wherein arranging the heating element comprises:

inserting the heating element into a space between the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal; and

advancing at least one of the outer sealing surface of the medical container seal or the outer sealing surface of the housing seal towards the heating element to a position in which the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal each contact the heating element.

12 . The method of claim 1 , wherein the medicament container is empty.

13 . The method of claim 1 , wherein the medicament container contains a medicament.

14 . The method of claim 1 , wherein:

the predetermined temperature exceeds 200° C., and

the predetermined period of time is at least 15 seconds.

15 . The method of claim 1 , wherein fixing the medicament container in the final position further comprises deforming the medicament container seal and the housing seal.

16 . The method of claim 1 , wherein arranging the heating element between the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal further comprises contacting the heating element with majorities of both the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal.

17 . The method of claim 16 , wherein arranging the heating element between the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal further comprises contacting the heating element with an entirety of both the outer sealing surface of the medical container seal and the outer sealing surface of the housing seal.

18 . The method of claim 1 , wherein removing the heating element further comprises withdrawing the heating element in a direction substantially perpendicular to a direction in which the force is applied.