Devices, systems and methods for medicament delivery

• US 8,123,719 B2
• Filed: 03/28/2007
• Issued: 02/28/2012
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Edwards, Eric Shawn, Edwards, Evan Thomas, Licata, Mark J., Meyers, Paul F.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US11/692,359
• Publication Number:
  US 20080103490A1
• Time in Patent Office: 1,798 Days
• Field of Search: 604/82, 604/84, 604 89- 92, 604/518
• US Class Current: 604/82
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• 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 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2039/1083 having a plurality of female connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2039/1088 having a plurality of male connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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 5/2046 : Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 : Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2066 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/24 : Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• 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: A61M 5/326 : Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/20 : for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

An apparatus includes a housing, a medicament container disposed within the housing, a first energy storage member and second energy storage member. The medicament container includes a first plunger disposed within a proximal end portion of the medicament container and a second plunger disposed within the medicament container spaced apart from the first plunger. The first energy storage member is configured to produce a force when actuated to move at least the second plunger within the medicament container. The second energy storage member is configured to produce a force when actuated to move the first plunger and the second plunger within the medicament container. The second energy storage member is different than the first energy storage member.

Claims

1. An apparatus, comprising:

a housing;

a medicament container disposed within the housing, the medicament container having a first plunger disposed within a proximal end portion of the medicament container and a second plunger disposed within the medicament container spaced apart from the first plunger, the first plunger, a portion of the medicament container and the second plunger collectively defining, at least in part, a first medicament containing portion containing a liquid medicament, the second plunger and a distal end portion of the medicament container collectively defining, at least in part, a second medicament containing portion containing a substantially dry medicament;

a first energy storage member configured to produce a force when actuated to move at least the second plunger within the medicament container, the first medicament containing portion being placed in fluid communication with the second medicament containing portion when the second plunger is moved in response to the first energy storage member being actuated, the first energy storage member being any one of a spring or a compressed gas container; and

a second energy storage member configured to produce a force when actuated to move the first plunger and the second plunger within the medicament container, the second energy storage member different than the first energy storage member, the second energy storage member being any one of a spring or a compressed gas container.

2. The apparatus of claim 1, wherein the second energy storage member is configured to be actuated independently from the first energy storage member.

3. The apparatus of claim 1, wherein:

the second medicament containing portion being placed in fluid communication with a needle when the first plunger and second plunger are moved in response to the second energy storage member being actuated.

4. The apparatus of claim 1, further comprising:

a first movable member operatively coupled to the first energy storage member such that the force produced by the first energy storage member acts on the first movable member to move at least the second plunger within the medicament container; and

a second movable member operatively coupled to the second energy storage member such that the force produced by the second energy storage member acts on the second movable member to move the first plunger and the second plunger within the medicament container,

a portion of the first movable member disposed within the second movable member.

5. The apparatus of claim 1, wherein:

the first energy storage member is a first spring configured to be actuated by a first actuator; and

the second energy storage member is second spring configured to be actuated by a second actuator, different than the first actuator.

6. The apparatus of claim 1, wherein the first energy storage member is configured to be actuated by an actuator movably coupled to the housing, the apparatus further comprising:

a cover configured to be disposed about at least a portion of the housing such that the actuator is obstructed by the cover.

7. The apparatus of claim 1, wherein a longitudinal axis of the second energy storage member is offset from a longitudinal axis of the medicament container.

8. The apparatus of claim 1, wherein:

substantially dry medicament includes a glucagon formulation.

9. The apparatus of claim 1, wherein the second energy storage member is further configured to move the medicament container in a first direction within the housing, the apparatus further comprising:

a coil spring configured to produce a force to move the medicament container in a second direction opposite the first direction.

10. An apparatus, comprising:

a housing;

a medicament container disposed within the housing, the medicament container including a first plunger and a second plunger, the first plunger, a portion of the medicament container and the second plunger collectively defining, at least in part, a first volume containing a first substance, the second plunger and a distal end portion of the medicament container collectively defining, at least in part, a second volume containing a second substance;

a mixing assembly including a mixing member and a first spring, the mixing assembly configured to place the first volume in fluid communication with the second volume when the mixing assembly is moved from a first mixing configuration to a second mixing configuration, the first spring configured to produce a mixing force acting on the mixing member to move the mixing assembly from the first mixing configuration to the second mixing configuration when the mixing assembly is actuated; and

an injection assembly including an injection member and a second spring, the injection assembly configured to move the first plunger within the medicament container to expel a mixture of the first substance and the second substance when the injection assembly is moved from a first injection configuration to a second injection configuration, the second spring configured to produce an injection force acting on the injection member to move the injection assembly from the first injection configuration to the second injection configuration when the injection assembly is actuated.

11. The apparatus of claim 10, wherein:

the mixing assembly is configured to move at least the second plunger within the medicament container to place the first volume in fluid communication with the second volume; and

the injection assembly configured to move the first plunger and the second plunger within the medicament container.

12. The apparatus of claim 10, further comprising:

a needle coupled to the medicament container,

the injection assembly configured to move the medicament container within the housing from a first position to a second position, the needle disposed within the housing when the medicament container is in the first position, at least a distal end portion of the needle disposed outside of the housing when the medicament container is in the second position.

13. The apparatus of claim 10, wherein:

the mixing member is configured to move the second plunger when the mixing assembly is actuated; and

the injection member is configured to move the first plunger and the second plunger within the medicament container, a portion of the mixing member disposed within the injection member.

14. The apparatus of claim 10, wherein a longitudinal axis of the second spring is offset from a longitudinal axis of the medicament container.

15. The apparatus of claim 10, wherein:

the mixing assembly is configured to be actuated by a first actuator; and

the injection assembly is configured to be actuated by a second actuator, different than the first actuator.

16. The apparatus of claim 10, wherein the mixing assembly is configured to be actuated by an actuator movably coupled to the housing, the apparatus further comprising:

a cover configured to be movably disposed about at least a portion of the housing such that the actuator is obstructed by the cover.

17. The apparatus of claim 10, wherein the first substance is a liquid and the second substance is a substantially dry glucagon formulation.

18. The apparatus of claim 10, further comprising:

a needle coupled to the medicament container, the injection assembly configured to move the medicament container within the housing from a first position to a second position, the needle disposed within the housing when the medicament container is in the first position, at least a distal end portion of the needle disposed outside of the housing when the medicament container is in the second position; and

a retraction spring configured to produce a force to move the medicament container from the second position back towards the first position.

19. An apparatus, comprising:

a housing;

a medicament container disposed within the housing, the medicament container including a first plunger and a second plunger, the first plunger, a portion of the medicament container and the second plunger collectively defining, at least in part, a first volume, the second plunger and a distal end portion of the medicament container collectively defining, at least in part, a second volume;

a mixing member having a portion in contact with the first plunger, the mixing member configured to move, at least partially within the medicament container, from a first position to a second position to move at least the second plunger within the medicament container;

a first spring configured to produce a first force to move the mixing member;

an injection member configured to move the first plunger and the second plunger within the medicament container; and

a second spring configured to produce a second force to move the injection member,

the mixing member configured to move relative to the injection member when moved from its first position to its second position.

20. The apparatus of claim 19, wherein:

the portion of the mixing member is a first portion; and

a second portion of the mixing member is slidably disposed within the injection member.

21. The apparatus of claim 19, further comprising:

a mixing actuator assembly configured to initiate movement of the mixing member, the mixing actuator assembly including a release member movably disposed within the housing, a longitudinal axis of the release member being offset from a longitudinal axis of the medicament container.

22. The apparatus of claim 19, further comprising:

an injection actuator assembly configured to initiate movement of the injection member, the injection actuator assembly including a release member movably disposed within the housing, a longitudinal axis of the release member being offset from a longitudinal axis of the medicament container.

23. The apparatus of claim 19, further comprising:

an actuator member disposed at least partially outside of the housing, the actuator member configured to initiate movement of the mixing member when the actuator member is manipulated by a user; and

a cover configured to be movably disposed about at least a portion of the housing such that the actuator member is obstructed by the cover.

24. The apparatus of claim 19, wherein:

a longitudinal axis of the first spring is offset from a longitudinal axis of the second spring.

25. The apparatus of claim 19, wherein:

the first volume contains a liquid;

the second volume contains a substantially dry glucagon formulation; and

the first volume is placed in fluid communication with the second volume when the second plunger is moved within the medicament container in response to the mixing member moving from its first position to its second position.

26. An apparatus, comprising:

a housing;

a medicament container disposed within the housing, the medicament container including a first plunger and a second plunger, the first plunger, a portion of the medicament container and the second plunger collectively defining, at least in part, a first volume, the second plunger and a distal end portion of the medicament container collectively defining, at least in part, a second volume;

a mixing member having a portion configured to move within the medicament container from a first position to a second position to move the second plunger within the medicament container;

a first spring configured to produce a first force to move the mixing member;

an injection member configured to move the first plunger and the second plunger within the medicament container; and

a second springy, configured to produce a second force to move the injection member,

the portion the mixing member being slidably disposed within the injection member.

27. The apparatus of claim 26, wherein the mixing member is configured to be actuated independently from the injection member.

28. The apparatus of claim 26, further comprising:

a mixing actuator assembly configured to initiate movement of the mixing member, the mixing actuator assembly including a release member movably disposed within the housing, a longitudinal axis of the release member being offset from a longitudinal axis of the medicament container.

29. The apparatus of claim 26, further comprising:

an injection actuator assembly configured to initiate movement of the injection member, the injection actuator assembly including a release member movably disposed within the housing, a longitudinal axis of the release member being offset from a longitudinal axis of the medicament container.

30. The apparatus of claim 26, further comprising:

an actuator member disposed at least partially outside of the housing, the actuator member configured to initiate movement of the mixing member when the actuator member is manipulated by a user; and

a cover configured to be movably disposed about at least a portion of the housing such that the actuator member is obstructed by the cover.