Devices and methods for delivering medicaments from a multi-chamber container

• US 9,173,999 B2
• Filed: 01/25/2012
• Issued: 11/03/2015
• Est. Priority Date: 01/26/2011
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Blondino, Frank E.
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US13/357,936
• Publication Number:
  US 20130023822A1
• Time in Patent Office: 1,378 Days
• Field of Search: 604 82- 90, 604131-139, 604/183, 604/191, 604/201, 604/207
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• CPC Class Codes: A61M 2005/2086 having piston damping means, e.g. axially or rotationally acting retarders
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/3202 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 Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

An apparatus includes a housing, a medicament container, and a movable assembly. The movable assembly includes a first movable member and a second movable member. The second movable member is configured to move relative to the first movable member to move the movable assembly from a first configuration to a second configuration. A distal end portion of the second movable member is configured to move a plunger disposed within the medicament container in a distal direction when the movable assembly is moved to the second configuration. The movable assembly is configured to move between a first position and a second position to move the medicament container within the housing between a first container position and a second container position.

Claims

1. An apparatus, comprising:

a housing;

a medicament container assembly at least partially disposed within the housing, the medicament container assembly including a first elastomeric member and a second elastomeric member, the first elastomeric member defining, at least in part, a first volume, the second elastomeric member defining, at least in part, a second volume; and

a movable assembly including a first movable member and a second movable member, the second movable member configured to move within the medicament container assembly in a distal direction relative to the first movable member to change the movable assembly from a first configuration to a second configuration, a distal end portion of the second movable member configured to move at least the second elastomeric member in the distal direction within the medicament container assembly when the movable assembly changes from the first configuration to the second configuration,

the first movable member configured to move the first elastomeric member in the distal direction within the medicament container assembly to expel at least a portion of the contents of the first volume and the second volume,

the second movable member including a retention portion, the retention portion being retracted when the movable assembly is in the first configuration and being extended when the movable assembly is in the second configuration, the retention portion configured to limit movement of the second movable member in a proximal direction relative to the medicament container assembly when the movable assembly is in the second configuration.

2. The apparatus of claim 1, wherein:

the first volume contains a first substance, and the second volume contains a second substance.

3. The apparatus of claim 2, wherein the second substance is selected from the group consisting of adalimumab, atropine, buprenorphine, certolizumab, cetirizine, diazepam, diphenhydramine, epinephrine, etanercept, exenatide, glucagon, haloperidol, hydroxyzine, insulin, ketorolac, lixisenatide, lorazepam, methotrexate, midazolam, obidoxime chloride, pralidoxime chloride, and combinations thereof.

4. The apparatus of claim 2, wherein the second substance is a substantially dry glucagon formulation, wherein the formulation further comprises a carbohydrate.

5. The apparatus of claim 1, wherein the movable assembly is configured to move the medicament container assembly within the housing after the movable assembly is in the second configuration.

6. The apparatus of claim 1, wherein:

a length of the movable assembly increases when the second movable member moves relative to the first movable member.

7. The apparatus of claim 1, wherein:

a proximal end portion of the second movable member is disposed outside of a proximal end portion of the first movable member when the movable assembly is in the first configuration, the proximal end portion of the second movable member is disposed outside of a distal end portion of the first movable member when the movable assembly is in the second configuration.

8. The apparatus of claim 1, wherein:

a portion of the second movable member configured to be slidably disposed within a piston portion of the first movable member.

9. The apparatus of claim 1, wherein:

the retention portion is configured to limit movement of the second movable member relative to the first movable member when the retention portion is engaged with a release member.

10. The apparatus of claim 1, wherein:

the retention portion is a first retention portion,

the second movable member includes a second retention portion, the second retention portion configured to limit movement of the second movable member relative to the first movable member when the movable assembly is in the first configuration.

11. The apparatus of claim 1, wherein:

the retention portion is a first retention portion,

the first movable member includes a second retention portion configured to engage a portion of the housing to maintain a movable assembly in the first position within the housing.

12. The apparatus of claim 1, wherein:

a portion of the second movable member is disposed within the first movable member when the movable assembly is in the first configuration, the portion of the second movable member is disposed outside of the first movable member when the movable assembly is in the second configuration.

13. The apparatus of claim 1, wherein the movable assembly includes an energy storage member configured to produce a force to move the second movable member relative to the first movable member.

14. The apparatus of claim 1, wherein:

a portion of the second movable member is disposed within the first movable member; and

the movable assembly includes a spring disposed within the first movable member and the second movable member, the spring configured to produce a force to move the second movable member relative to the first movable member.

15. The apparatus of claim 1, wherein:

the movable assembly includes a first energy storage member configured to produce a first force to move the second movable member relative to the first movable member; and

the first movable member is configured to be operably coupled to a second energy storage member configured to produce a second force to move the movable assembly from the first position to the second position.

16. The apparatus of claim 1, wherein a portion of the movable assembly is configured to actuate an electronic circuit system.

17. The apparatus of claim 1, wherein the medicament container assembly defines at least one channel configured to place the first volume in fluid communication with the second volume as the movable assembly moves from the first configuration to the second configuration.

18. An apparatus, comprising:

a housing;

a medicament container at least partially disposed within the housing, the medicament container including a first elastomeric member and a second elastomeric member, the first elastomeric member defining, at least in part, a first volume, the second elastomeric member defining, at least in part, a second volume; and

a movable assembly configured to move at least the second elastomeric member in a distal direction a first distance within the medicament container when the movable assembly moves from a first configuration to a second configuration such that a first substance within the first volume is mixed with a second substance within the second volume, a length of the movable assembly increasing when the movable assembly moves from the first configuration to the second configuration,

the movable assembly configured to move at least the first elastomeric member a second distance within the medicament container when at least a portion of the movable assembly moves within the housing after the movable assembly has been moved to the second configuration to expel at least a portion of the contents of the first volume and the second volume,

the movable assembly includes a first movable member and a second movable member, the second movable member configured to move relative to the first movable member to change the movable assembly from the first configuration to the second configuration,

the movable assembly includes a retention portion configured to limit movement of the second movable member when the movable assembly is in the second configuration.

19. The apparatus of claim 18, wherein:

the movable assembly is configured to move the medicament container from a first medicament container position to a second medicament container position when the movable assembly moves within the housing.

20. The apparatus of claim 18, wherein:

the movable assembly configured to move the medicament container from a first medicament container position to a second medicament container position when the movable assembly moves from a first position within the housing to a second position within the housing,

the movable assembly configured to move at least the first elastomeric member the second distance when the movable assembly moves from the second position within the housing to a third position within the housing.

21. The apparatus of claim 18, wherein:

the first volume contains a first substance, and the second volume contains a second substance.

22. The apparatus of claim 18, wherein a piston portion of the first movable member is configured to move within the medicament container to move at least the first elastomeric member the second distance, a portion of the second movable member configured to be slidably disposed within the piston portion of the first movable member, the portion of the second movable member configured to move within the first movable member to change the movable assembly from the first configuration to the second configuration.

23. The apparatus of claim 18, wherein the movable assembly includes an energy storage member configured to produce a force to change the movable assembly from the first configuration to the second configuration.

24. The apparatus of claim 18, wherein:

the movable assembly includes a first energy storage member configured to produce a first force to change the movable assembly from the first configuration to the second configuration; and

the movable assembly is configured to be operably coupled to a second energy storage member configured to produce a second force to move the movable assembly within the housing to move the first elastomeric member the second distance within the medicament container.

25. The apparatus of claim 18, wherein the movable assembly includes a spring configured to urge the movable assembly toward the second configuration, the apparatus further comprising:

a release member configured to maintain the spring in a compressed configuration when the release member is engaged with the movable assembly.

26. The apparatus of claim 18, wherein the medicament container defines at least one channel configured to place the first volume in fluid communication with the second volume as the movable assembly moves from the first configuration to the second configuration.

27. The apparatus of claim 18, wherein:

the retention portion being retracted when the movable assembly is in the first configuration, the retention portion being extended when the movable assembly is in the second configuration.

28. The apparatus of claim 18, wherein:

the retention portion being in a retracted position when the movable assembly is in the first configuration, the retention portion being in an extended position when the movable assembly is in the second configuration, the retention portion biased in the extended position.

29. An apparatus, comprising:

a housing including an aperture;

a medicament container at least partially disposed within the housing, the medicament container including a first elastomeric member and a second elastomeric member, the first elastomeric member defining, at least in part, a first volume, the second elastomeric member defining, at least in part, a second volume;

a movable member configured to move at least the first elastomeric member within the medicament container;

a release member having a pivot portion pivotably couple to the housing via the aperture, a first end portion and a second end portion, the second end portion configured to move between a first position and a second position, the second end portion of the release member configured to limit movement of the movable member when the second end portion is in the first position, the release member configured such that when the first end portion is moved in a first direction, the second end portion moves in a second direction from the first position to the second position, the second direction different than the first direction;

a needle configured to be placed in fluid communication with the medicament container; and

a needle cover assembly covering at least a portion of the needle when the needle cover assembly is coupled to the housing, the first end portion of the release member coupled to a portion of the needle cover assembly such that when the needle cover assembly is removed from the housing, the first end portion is moved in the first direction.

30. The apparatus of claim 29, wherein the second end portion is engaged with a portion of the movable member when the second end portion is in the first position, the second end portion is spaced apart from the movable member when the second end portion is in the second position.

31. The apparatus of claim 29, wherein the release member is configured to amplify a force applied to the first end portion when the force is transferred to the second end portion.

32. The apparatus of claim 29, wherein the first end portion of release member spaced apart from the pivot portion by a first distance, the second end portion of the release member spaced apart from the pivot portion by a second distance, the second distance different than the first distance.

33. The apparatus of claim 29, wherein the release member includes a pivot protrusion configured to be disposed within the aperture, at least a portion of the release member configured to rotate about the pivot protrusion when the second end portion is moved from the first position to the second position.

34. The apparatus of claim 29, wherein the pivot portion is configured to deform when the first end portion is moved in the first direction.

35. The apparatus of claim 29, wherein the second direction is substantially normal to the first direction.

36. The apparatus of claim 29, wherein the first end portion is configured to actuate an electronic circuit system when the first end portion is moved in the first direction.

37. The apparatus of claim 29, wherein:

the first volume contains a first substance, and the second volume contains a second substance; and

the movable member is a mixing piston configured to move the first elastomeric member to mix the first substance and the second substance.

38. The apparatus of claim 37, further comprising:

an energy storage member configured to produce a force to convey the first substance and the second substance from the medicament container;

an actuation member configured to actuate the energy storage member when the actuation member is moved; and

a safety lock movably coupled to the housing, the safety lock configured to engage a portion of the actuation member to limit movement of the actuation member,

the first end portion of the release member coupled to the safety lock such that when the safety lock is moved relative to the housing, the first end portion is moved in the first direction.