DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY

• US 20080103490A1
• Filed: 03/28/2007
• Published: 05/01/2008
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Meyers, Paul F., Edwards, Eric Shawn, Licata, Mark J., Edwards, Evan Thomas
• Granted Patent: US 8,123,719 B2
• Time in Patent Office: Days
• US Class Current: 604/890.1
• 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 and a medicament container disposed within the housing. The medicament container includes a first plunger and a second plunger, each disposed therein. The medicament container has a first configuration and a second configuration. In the first configuration, the first plunger is disposed in a first position and the second plunger is disposed in a second position spaced apart from the first position by a first distance. Accordingly, a first portion is defined between the first plunger and the second plunger. A second portion is defined between the second plunger and a distal end of the medicament container. In the second configuration, the first plunger remains in the first position and the second plunger is disposed in a third position spaced apart from the first position by a second distance, such that a volume of the second portion is greater when the medicament container is in the second configuration than when in the first configuration.

Claims

1. An apparatus, comprising:

a housing; and

a medicament container disposed within the housing, the medicament container having a first plunger disposed within the medicament container and a second plunger disposed within the medicament container,

the first plunger disposed in a first position within the medicament container and the second plunger disposed in a second position spaced apart from the first position by a first distance such that a first medicament containing portion is defined between the first plunger and the second plunger and a second medicament containing portion is defined between the second plunger and a distal end of the medicament container when the medicament container is in a first configuration,

the first plunger disposed in the first position within the medicament container and the second plunger disposed in a third position spaced apart from the first position by a second distance when the medicament container is in a second configuration,

a volume of the second medicament containing portion being greater when the medicament container is in the second configuration than when the medicament container is in the first configuration.

2. The apparatus of claim 1, wherein:

the first medicament containing portion contains a liquid medicament; and

the second medicament containing portion contains a solid medicament.

3. The apparatus of claim 1, wherein:

the first medicament containing portion is fluidically isolated from the second medicament containing portion when the medicament container is in the first configuration; and

the first medicament containing portion is in fluid communication with the second medicament containing portion when the medicament container is being moved from the first configuration to the second configuration.

4. The apparatus of claim 1, wherein the second plunger is configured to allow fluid communication between the first medicament containing portion and the second medicament containing portion to mix a medicament contained in the first medicament containing portion with a medicament contained in the second medicament containing portion when the medicament container is being moved from the first configuration to the second configuration.

5. The apparatus of claim 1, wherein a portion of the second plunger contacts a portion of the first plunger when the medicament container is in the second configuration.

6. The apparatus of claim 1, wherein:

a volume of the first medicament containing portion when the medicament container is in the second configuration is substantially zero; and

the volume of the second medicament containing portion when the medicament container is in the second configuration is substantially equal to the sum of the volume of the of the first medicament containing portion when the medicament container is in the first configuration and the volume of the second medicament containing portion when the medicament container is in the first configuration.

7. The apparatus of claim 1, wherein:

the first plunger is disposed in a fourth position within the medicament container when the medicament container is in a third configuration;

the second plunger is disposed such that a volume of the first medicament containing portion is substantially zero when the medicament container is in the third configuration; and

the volume of the second medicament containing portion when the medicament container is in the third configuration is less than the sum of the volume of the of the first medicament containing portion when the medicament container is in the first configuration and the volume of the second medicament containing portion when the medicament container is in the first configuration.

8. The apparatus of claim 1, further comprising a movable member configured to move the second plunger between the second position and the third position.

9. The apparatus of claim 1, further comprising a movable member configured to move the second plunger between the second position and the third position, the movable member being offset from a longitudinal axis of the medicament container.

10. The apparatus of claim 7, further comprising:

a needle defining a lumen therethrough, the lumen being fluidically isolated from the second medicament containing portion of the medicament container when the medicament container is the first configuration and the second configuration,

the lumen being in fluid communication with the second medicament containing portion of the medicament container when the medicament container is in the third configuration.

11. 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;

a first movable member configured to move the first plunger within the medicament container toward a distal end of the medicament container; and

a second movable member configured to move the second plunger within the medicament container toward the proximal end portion of the medicament container.

12. The apparatus of claim 11, wherein the second movable member is configured to move the second plunger without moving the first plunger.

13. The apparatus of claim 11, wherein the second movable member is configured to move the second plunger from a first position, in which the second plunger is disposed within a central portion of the medicament container to a second position, in which a portion of the second plunger engages the first plunger.

14. The apparatus of claim 11, wherein:

a first medicament containing portion is defined between the first plunger and the second plunger, the first medicament containing portion containing a liquid medicament; and

a second medicament containing portion is defined between the second plunger and the distal end of the medicament container, the second medicament containing portion containing a solid medicament.

15. The apparatus of claim 11, wherein:

a first medicament containing portion is defined between the first plunger and the second plunger, the first medicament containing portion containing a liquid medicament; and

a second medicament containing portion is defined between the second plunger and the distal end of the medicament container, the second medicament containing portion containing a solid medicament,

at least one of the first medicament containing portion or the second medicament containing portion being devoid of a gas.

16. The apparatus of claim 11, wherein:

a first medicament containing portion is defined between the first plunger and the second plunger;

a second medicament containing portion is defined between the second plunger and the distal end of the medicament container; and

the second plunger is configured to allow fluid communication between the first medicament containing portion and the second medicament containing portion when the second plunger is moving within the medicament container.

17. The apparatus of claim 11, wherein:

a first medicament containing portion is defined between the first plunger and the second plunger;

a second medicament containing portion is defined between the second plunger and the distal end of the medicament container; and

the second plunger includes a valve configured to configured to allow fluid communication between the first medicament containing portion and the second medicament containing portion when the second plunger is moving within the medicament container.

18. The apparatus of claim 11, wherein:

the second movable member is coupled to the second plunger; and

a portion of the second movable member is disposed through an opening defined by the first plunger.

19. The apparatus of claim 11, wherein:

a first end of the first movable member is configured to engage the first plunger;

a second end of the first movable member is operatively coupled to a first energy storage member configured to move the first movable member when moving from a first configuration to a second configuration;

a first end of the second movable member is configured to engage the second plunger; and

a second end of the second movable member is operatively coupled to a second energy storage member configured to move the second movable member when moving from a first configuration of the second energy storage member to a second configuration of the second energy storage member.

20. The apparatus of claim 11, wherein the medicament container is movably disposed within the housing.

21. The apparatus of claim 11, further comprising:

a needle defining a lumen therethrough, the lumen being fluidically isolated from the distal end of the medicament container when the medicament container is in a first position within the housing, the lumen being in fluid communication with the distal end of the medicament container when the medicament container is in a second position within the housing,

the first movable member configured to move the medicament container from the first position to the second position.

22. 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;

a first energy storage member configured to produce a force when moved from a first configuration to a second configuration to move the first plunger within the medicament container; and

a second energy storage member configured to produce a force when moved from a first configuration to a second configuration to move the second plunger within the medicament container, the second energy storage member different than the first energy storage member.

23. The apparatus of claim 22, wherein the second plunger is configured to move independently from the first plunger.

24. The apparatus of claim 22, wherein the second plunger is configured to move from a first position, in which the second plunger is disposed within a central portion of the medicament container to a second position, in which a portion of the second plunger engages the first plunger.

25. The apparatus of claim 22, wherein:

a first medicament containing portion is defined between the first plunger and the second plunger, the first medicament containing portion containing a liquid medicament; and

a second medicament containing portion is defined between the second plunger and a distal end of the medicament container, the second medicament containing portion containing a solid medicament.

26. The apparatus of claim 22, wherein:

a first medicament containing portion is defined between the first plunger and the second plunger;

a second medicament containing portion is defined between the second plunger and a distal end of the medicament container; and

the second plunger is configured to allow fluid communication between the first medicament containing portion and the second medicament containing portion when the second plunger is moving within the medicament container.

27. The apparatus of claim 22, further comprising:

a first movable member operatively coupled to the first energy storage member, the first movable member configured to move the first plunger within the medicament container toward a distal end of the medicament container; and

a second movable member operatively coupled to the second energy storage member, the second movable member configured to move the second plunger within the medicament container toward the proximal end portion of the medicament container.

28. The apparatus of claim 22, wherein:

the first energy storage member is configured to be moved from its first configuration to its second configuration by an actuator; and

the second energy storage member is configured to be moved from its first configuration to its second configuration by the actuator.

29. The apparatus of claim 22, wherein:

the first energy storage member is configured to be moved from its first configuration to its second configuration by a first actuator; and

the second energy storage member is configured to be moved from its first configuration to its second configuration by a second actuator, different than the first actuator.

30. The apparatus of claim 22, wherein:

the first energy storage member is configured to be moved from its first configuration to its second configuration by a first actuator disposed at a distal end portion of the housing; and

the second energy storage member is configured to be moved from its first configuration to its second configuration by a second actuator disposed at a side portion of the housing.

31. The apparatus of claim 22, wherein:

the first energy storage member is any one of a spring, an electrical storage member, a compressed gas container or a chemical storage member; and

the second energy storage member is any one of a spring, an electrical storage member, a compressed gas container or a chemical storage member.

32. 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 such that the medicament container is divided into a first medicament containing portion and a second medicament containing portion; and

a movable member configured to move the second plunger within the medicament container to mix a medicament contained in the first medicament containing portion with a medicament contained in the second medicament containing portion, the movable member being offset from a longitudinal axis of the medicament container.

33. The apparatus of claim 32, further comprising a piston configured to move the first plunger within the medicament container.

34. The apparatus of claim 32, wherein the movable member is configured to move the second plunger within the medicament container toward the proximal end portion of the medicament container, the apparatus further comprising a piston configured to move the first plunger within the medicament container toward a distal end of the medicament container.

35. The apparatus of claim 32, wherein the movable member is configured to move the second plunger from a first position, in which the second plunger is disposed within a central portion of the medicament container to a second position, in which a portion of the second plunger engages the first plunger.

36. The apparatus of claim 32, wherein:

the first medicament containing portion contains a liquid medicament; and

the second medicament containing portion contains a solid medicament.

37. The apparatus of claim 32, wherein the second plunger is configured to allow fluid communication between the first medicament containing portion and the second medicament containing portion when the second plunger is moving within the medicament container.

38. The apparatus of claim 32, wherein:

a first end of the movable member is configured to engage the second plunger; and

a second end of the movable member is operatively coupled to an energy storage member configured to move the movable member when moving from a first configuration to a second configuration.

39. The apparatus of claim 32, wherein the medicament container is movably disposed within the housing.

40. A method, comprising:

moving a mixing plunger within a medicament container toward a proximal end of the medicament container, the mixing plunger disposed within the medicament container between a distal end of the medicament container and an injection plunger disposed at the proximal end of the medicament container; and

moving the injection plunger within the medicament container toward a distal end of the medicament container to expel a medicament contained within the medicament container.

41. The method of claim 40, wherein the moving the mixing plunger includes moving the mixing plunger without moving the injection plunger.

42. The method of claim 40, wherein the moving the mixing plunger includes moving the mixing plunger such that a solid substance contained within the medicament container and a liquid substance contained within the medicament container are mixed to produce the medicament.

43. The method of claim 40, wherein the moving the mixing plunger includes actuating an energy storage member.

44. The method of claim 40, wherein:

the moving the mixing plunger includes actuating a first energy storage member; and

the moving the injection plunger includes actuating a second energy storage member different than the first energy storage member.

45. The method of claim 40, wherein:

the moving the injection plunger includes moving the injection plunger toward the distal end of the medicament container after the moving the mixing plunger toward the proximal end of the medicament container.

46. The method of claim 40, further comprising:

moving the medicament container within a housing of a medical injector such that a needle is disposed from a distal end of the housing before the moving the injection plunger.

47. The method of claim 40, further comprising:

moving the medicament container within a housing of a medical injector such that a needle is disposed from a distal end of the housing before the moving the injection plunger; and

placing the needle in fluid communication with the medicament container before the moving the injection plunger.

48. The method of claim 40, further comprising:

moving the medicament container within a housing of a medical injector such that a needle is disposed from a distal end of the housing before the moving the injection plunger;

placing the needle in fluid communication with the medicament container before the moving the injection plunger; and

retracting the needle into the housing after the moving the injection plunger.