Devices, systems and methods for medicament delivery

• US 9,867,938 B2
• Filed: 12/22/2014
• Issued: 01/16/2018
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric Shawn, Edwards, Evan Thomas, Licata, Mark J., Meyers, Paul F.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US14/579,298
• Publication Number:
  US 20150174323A1
• Time in Patent Office: 1,121 Days
• 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 medicament container assembly, a movable assembly, and a spring. The medicament container assembly includes a first plunger defining a first volume, and a second plunger defining a second volume. The movable assembly includes a first movable member and a second movable member. The second movable member can move the second plunger within the medicament container assembly. The first movable member can move the first plunger in a first direction within the medicament container assembly to expel contents of at least the first volume via a needle. The spring is configured to urge the needle in a second direction. The release portion of the first movable member is configured to contact the second movable member after the first movable member moves the first plunger to enable the spring to move the needle in the second direction.

Claims

1. An apparatus, comprising:

a housing;

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

the second elastomeric member and a distal end portion of the medicament container collectively defining, at least in part, a second medicament volume containing a dry medicament; and

an energy storage member configured to produce a first force when actuated to move at least the second elastomeric member within the medicament container in a proximal direction to place the first medicament volume in fluid communication with the second medicament volume, the energy storage member defining a longitudinal axis that is non-coaxial with a longitudinal axis of the medicament container,

the second elastomeric member configured to move in a distal direction in response to a second force to convey a mixture of the liquid medicament and the dry medicament from the distal end portion of the medicament container.

2. The apparatus of claim 1, further comprising:

a needle coupled to the distal end portion of the medicament container, the needle configured to be placed in fluid communication with the second medicament volume; and

a retraction spring configured to produce a third force to move the needle in the proximal direction after the mixture of the liquid medicament and the dry medicament is conveyed from the medicament container.

3. The apparatus of claim 1, wherein the energy storage member is a first energy storage member, the apparatus further comprising:

a second energy storage member configured to produce the second force, the second energy storage member different from the first energy storage member.

4. The apparatus of claim 1, wherein:

the medicament container includes a side wall including the portion of the medicament container defining the first medicament volume and the distal end portion of the medicament container;

the first elastomeric member and a first portion of the side wall forming a first fluid-tight seal; and

the second elastomeric member moves in the proximal direction from a first position to a second position to place the first medicament volume in fluid communication with the second medicament volume, the second elastomeric member and a second portion of the side wall forming a second fluid-tight seal when the second elastomeric member is in the first position.

5. The apparatus of claim 1, wherein the dry medicament includes a glucagon formulation.

6. The apparatus of claim 1, wherein the energy storage member is configured to exert the first force in the proximal direction.

7. An apparatus comprising:

a housing;

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

a movable member configured to receive a first force from an energy storage member to move at least the second elastomeric member within the medicament container in a proximal direction to place the first medicament volume in fluid communication with the second medicament volume, the movable member configured to move in a distal direction in response to a second force to convey a mixture of the liquid medicament and the dry medicament from the distal end portion of the medicament container.

8. The apparatus of claim 7, wherein the movable member includes a surface against which the first force from the energy storage member is received, the movable member configured to move in the proximal direction within the housing when the first force is received.

9. The apparatus of claim 7, wherein the medicament container has a side wall defining an opening, the first elastomeric member disposed through the opening and in contact with a first portion of the side wall, the second elastomeric member disposed through the opening and in contact with a second portion of the side wall.

10. The apparatus of claim 7, wherein a needle is coupled to the distal end portion of the medicament container such that a lumen defined by the needle is in fluid communication with the second medicament volume.

11. The apparatus of claim 7, further comprising:

a retraction spring configured to produce a third force to move the movable member in the proximal direction after the mixture of the liquid medicament and the dry medicament is conveyed from the medicament container.

12. The apparatus of claim 7, further comprising:

the energy storage member, the energy storage member being any one of a spring or a compressed gas container.

13. The apparatus of claim 7, further comprising:

the energy storage member, the energy storage member being a spring, the movable member including a surface in contact with an end portion of the spring.

14. The apparatus of claim 7, further comprising:

the energy storage member, the energy storage member being a spring, a longitudinal axis of the spring being offset from a longitudinal axis of the medicament container, the movable member including a surface in contact with an end portion of the spring.

15. A method, comprising:

moving, at a first time and in response to a first force produced by an energy storage member, a first elastomeric member within a medicament container from a first position to a second position toward a proximal end of the medicament container,

when the first elastomeric member is in the first position;

A) the first elastomeric member is disposed within the medicament container between a distal end of the medicament container and a second elastomeric member such that the first elastomeric member, a portion of the medicament container, and the second elastomeric member define a first medicament volume containing a liquid substance, and B) the first elastomeric member and the distal end of the medicament container define a second medicament volume, the second medicament volume containing a solid substance, when the first elastomeric member is moved toward the second position the first medicament volume is placed in fluid communication with the second medicament volume to produce a medicament; and

moving, at a second time and in response to a second force, the second elastomeric member within the medicament container toward the distal end of the medicament container to expel the medicament contained within the medicament container.

16. The method of claim 15, wherein the moving the first elastomeric member includes moving the first elastomeric member without moving the second elastomeric member.

17. The method of claim 15, wherein the moving the first elastomeric member includes actuating the energy storage member to produce the first force, the energy storage member disposed within a housing, a longitudinal axis of the energy storage member offset from a longitudinal axis of the medicament container.

18. The method of claim 15, wherein:

the energy storage member is a first energy storage member;

the moving the first elastomeric member includes actuating the first energy storage member to produce the first force; and

the moving the second elastomeric member includes actuating a second energy storage member to produce the second force, the second energy storage member different from the first energy storage member.

19. The method of claim 15, wherein:

the moving the second elastomeric member is performed after the moving the first elastomeric member toward the proximal end of the medicament container.

20. The method of claim 15, 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 second elastomeric member; and

placing the needle in fluid communication with the medicament container before the moving the second elastomeric member.

21. The method of claim 15, 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 second elastomeric member;

placing the needle in fluid communication with the medicament container before the moving the second elastomeric member; and

retracting the needle into the housing after the moving the second elastomeric member.