Apparatus and methods for sealing a medicament within a medical delivery device

Patent metadata

Field	Value
Publication number	US-11523969-B2
Application number	US-202016854144-A
Country	US
Kind code	B2
Filing date	Apr 21, 2020
Priority date	Aug 4, 2014
Publication date	Dec 13, 2022
Grant date	Dec 13, 2022

Abstract

Apparatus and methods for lyophilizing and sealing a medicament within a medical delivery device having an opening. The apparatus may include a stopper for sealing the opening. The stopper may have one or more elongated members extending from a base, in a direction that is parallel to a central axis of the base. One or more of the members may be set radially away from the axis and define a coaxial central well. The member or members may define a void. The elongated member or members may engage a device inner wall and support the base away from the opening. The void may provide gas exchange between a device interior and a device exterior. The gas may be a lyophilization byproduct that escapes from the device interior between the inner wall, the base and the member or members. The stopper may be advanced into the device to seal the opening.

First claim

What is claimed is:

1. A method of lyophilizing and sealing a medicament within a medical. delivery device, themethod comprising:
placing the medicament into the delivery device;
engaging an inner wall of the delivery device with a plurality of resilient elongated members that are fixed to a sealing base;
advancing the members into the device until the base is set apart from the inner wall by a predetermined offset, the base held in place relative to the device onlyby the members;
lyophilizing the medicament to produce avapor that escapes between the inner wall, the members and the base; and,
then, further advancing the members until the base seals against the inner wall.

2. A method of lyophilizing and sealing a medicament within a medical delivery device, themethod comprising:
placing the medicament into the device;
through an opening of the device, engaging an inner wall of the device with a resilient elongated member that is fixed to a sealing base;
advancing the member relative to the opening until the base is set apart from the opening by a predetermined offset, the base held in place relative to the device only by the member;
lyophilizing the medicament to produce avapor that escapes between the inner wall, the member and the base; and,
then, further advancing the member until the base seals against the inner wall.

3. The method of claim 1 wherein the members:
are set radially away from a central axis of the base; and
define, between circumferentially adjacent surfaces of the members, one or more than one void having a circumferential span.

4. The method of claim 3 wherein the predetermined offset is scaled in proportion to a ratio of the circumferential span to a circumference of the base.

5. The method of claim 4 wherein the predetermined offset ranges from about 1-35% of the ratio.

6. The method of claim 4 wherein the predetermined offset ranges from about 31-70% of the ratio.

7. The method of claim 4 wherein the predetermined offset ranges from about 66-99% of the ratio.

8. The method of claim 1 wherein the predetermined offkt is scaled in proportion to a length of longitudinal extension of the members from the base.

9. The method of claim 8 wherein the predetermined offset ranges from about 1-35% of the length.

10. The method of claim 8 wherein the predetermined offset ranges from about 31-70% of the length.

11. The method of claim 8 wherein the predetermined offset ranges from about 66-99% of the length.

12. The method of claim 2 Wherein the member:
is set radially away from a central axis of the base; and
defines, between circumferentially adjacent surfaces of the member, a void having a circumferential span.

13. The method of claim 12 wherein the predetermined offset is scaled in proportion to a ratio of the circumferential span to a circumference of the base.

14. The method of claim 13 wherein the predetermined offset ranges from about 1-35% of the ratio.

15. The method of claim 13 wherein the predetermined offset ranges from about 31-70% of the ratio.

16. The method of claim 13 wherein the predetermined offset ranges from about 66-99% of the ratio.

17. The method of claim 2 wherein the predetermined offset is scaled in proportion to a length of longitudinal extension of the member from the base.

18. The method of claim 17 wherein the predetermined offset ranges from about 1-35% of the length.

19. The method of claim 17 wherein the predetermined offset ranges from about 31-70% of the length.

20. The method of claim 17 wherein the predetermined offset ranges from about 66-99% of the length.

Assignees

• Genentech Inc

Inventors

• Vedrine Lionel

Classifications

• B65B7/161

  Sealing filled ampoules · CPC title

• A61M39/20 Primary

  Closure caps or plugs for connectors or open ends of tubes · CPC title

• A61J1/1412 Primary

  Containers with closing means, e.g. caps · CPC title

• B65B63/08

  for heating or cooling articles or materials to facilitate packaging · CPC title

• F26B5/06

  the process involving freezing · CPC title