Medicament packaging assembly

Patent metadata

Field	Value
Publication number	US-11833332-B2
Application number	US-201916968003-A
Country	US
Kind code	B2
Filing date	Feb 6, 2019
Priority date	Feb 6, 2018
Publication date	Dec 5, 2023
Grant date	Dec 5, 2023

Abstract

A medicament packaging assembly for installation in a medicament delivery device is disclosed. The packaging assembly comprises a cartridge having a medicament chamber, a sealing element for sealing a distal end of the medicament chamber, a sealing element release member, a cannula and a removable cap member. The assembly is switchable from a starting configuration in which the release member is spaced from the sealing element to an activated configuration in which the release member cooperates with the sealing element to connect the medicament chamber to the cannula. The packaging assembly further comprises a first chamber defined in part by the cap member and arranged for receiving the cannula such that at least a distal end of the cannula is sealed in the first chamber when the cap member is in place, and a second chamber defined in part by the sealing element and arranged for receiving the release member.

First claim

The invention claimed is:

1. A medicament packaging assembly for installation in a medicament delivery device, the packaging assembly comprising:
a cartridge having a medicament chamber for containing a medicament; a seal for sealing a distal end of the medicament chamber; a seal release; a cannula for delivery of the medicament; and a removable cap member;
wherein the cap member is arranged for engagement with an outer cap of the device and comprises at least one blocking finger for limiting movement of the cartridge in a distal direction toward the seal release when the cap member is in place, thereby to keep the packaging assembly in a starting configuration when the cap member is in place;
wherein, after removal of the cap member, the packaging assembly is configured to undergo relative movement between the seal release and the cartridge from the starting configuration in which the seal release is spaced from the seal to an activated configuration in which the seal release cooperates with the seal to connect the medicament chamber to the cannula;
the packaging assembly further comprising:
a first chamber defined in part by the cap member and arranged for receiving the cannula such that at least a distal end of the cannula is sealed in the first chamber when the cap member is in place; and
a second chamber defined in part by the seal and arranged for receiving the seal release such that at least a proximal end of the seal release is sealed in the second chamber when the packaging assembly is in the starting configuration;
wherein the packaging assembly can be pre-assembled in the starting configuration for subsequent installation in the device and the cap member is arranged to engage with the outer cap of the device upon application of a distally-directed force to the packaging assembly, the at least one blocking finger being arranged to keep the packaging assembly in the starting configuration in which the seal release is spaced from the seal during application of the distally-directed force.

2. A packaging assembly according to claim 1 , wherein the cap member comprises one or more clip formations for engagement with the outer cap.

3. A packaging assembly according to claim 1 , wherein the cap member has a diameter equal to or less than the diameter of the cartridge.

4. A packaging assembly according to claim 3 , wherein the maximum diameter of the packaging assembly is equal to the diameter of the cartridge.

5. A packaging assembly according to claim 1 , wherein the cap member comprises a vent for venting the first chamber, the vent comprising an air permeable sterile barrier material.

6. A packaging assembly according to claim 1 , further comprising a hub subassembly including a hub body, the cannula and the seal release.

7. A packaging assembly according to claim 6 , further comprising a coupling element attached to the cartridge, wherein the second chamber is defined in part by the coupling element and wherein an aseptic seal is formed between the hub body and the coupling element to seal the second chamber at least when the packaging assembly is in the starting configuration.

8. A packaging assembly according to claim 7 , wherein the hub body comprises a proximally-projecting boss for the seal release and wherein the second chamber is defined in part by a distally-projecting tubular member of the coupling element, the tubular member being arranged to receive the boss and the aseptic seal being formed between the tubular member and the boss at least when the packaging assembly is in the starting configuration.

9. A packaging assembly according to claim 8 , in which the hub subassembly comprises an elastomeric cap mounted on the boss, wherein the seal release projects through the elastomeric cap and wherein the elastomeric cap forms the aseptic seal between the tubular member and the boss.

10. A packaging assembly according to claim 7 , wherein the cap member is engageable with the hub body and wherein the at least one blocking finger extends proximally from the cap member to cooperate with the coupling element to limit relative movement between the seal release and the cartridge.

11. A packaging assembly according to claim 10 , wherein a tip of the at least one blocking finger is arranged to abut the coupling element to limit relative movement between the seal release and the cartridge.

12. A packaging assembly according to claim 7 , wherein the at least one blocking finger extends through a corresponding aperture in the hub body.

13. A packaging assembly according to claim 7 , wherein the coupling element is attached to a collar of the cartridge by a crimp fitting.

14. A packaging assembly according to claim 13 , wherein the coupling element comprises a skirt that extends over the collar to form the crimp fitting.

15. A packaging assembly according to claim 7 , wherein the seal comprises a septum, and wherein the coupling element clamps the septum against a distal end of the cartridge.

16. A packaging assembly according to claim 7 , comprising a clip formation arranged to allow engagement of the hub subassembly with the coupling element during assembly of the packaging assembly and to prevent subsequent disengagement of the hub subassembly from the coupling element.

17. A packaging assembly according to claim 16 , wherein the hub body comprises one or more inwardly-extending clips that cooperate with a collar of the coupling element to provide the clip formation.

18. A packaging assembly according to claim 1 , wherein the release comprises a tubular element arranged to pierce the seal upon switching of the packaging assembly into the activated configuration.

19. A packaging assembly according to claim 18 , wherein the cannula comprises a distal part of a needle and the seal release comprises a proximal part of the needle.

20. A method for assembling a medicament delivery device, comprising:
providing a medicament delivery device;
assembling a medicament packaging assembly according to claim 1 ; and
inserting the assembled packaging assembly into the medicament delivery device.

21. A method according to claim 20 , wherein the medicament delivery device further comprises a removable outer cap, and
the method further comprising engaging the cap member of the packaging assembly with the removable outer cap of the delivery device.

22. A method according to claim 20 , wherein the step of inserting the packaging assembly comprises applying a distally-directed force to the packaging assembly to engage the cap member with the outer cap.

23. A medicament delivery device comprising:
a medicament packaging assembly according to claim 6 ;
a housing for receiving the medicament packaging assembly according to claim 6 ;
the removable outer cap provided on a distal end of the housing, the outer cap being engageable with the cap member of the packaging assembly when the packaging assembly is inserted into the housing; and
an activation driver operable to cause relative movement between the cartridge and the hub subassembly, thereby to switch the packaging assembly from the starting configuration to the activated configuration to allow delivery of the medicament through the cannula.

24. A cannula module for use in a packaging assembly in which a medicament is contained in a medicament chamber of a cartridge, the cannula module comprising:
a seal for sealing an end of the medicament chamber, a coupling element, a cap sleeve member and

Assignees

• Owen Mumford Ltd

Inventors

• Cowe Toby
• Evans Timothy

Classifications

• A61M5/2466 Primary

  by piercing without internal pressure increase (A61M5/2429 takes precedence) · CPC title

• A61M5/002

  Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics (needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001) · CPC title

• A61M5/288 Primary

  by piercing without internal pressure increase (A61M5/283 takes precedence) · CPC title

• A61M5/3202

  Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001) · CPC title

• A61M2005/247

  with fixed or steady piercing means, e.g. piercing under movement of ampoule · CPC title