Devices, systems and methods for medicament delivery

• US 8,920,367 B2
• Filed: 12/15/2011
• Issued: 12/30/2014
• 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:
  US13/326,959
• Publication Number:
  US 20120116318A1
• Time in Patent Office: 1,111 Days
• Field of Search: 604/82, 604/84, 604 89- 91, 604/518
• US Class Current: 604/89
• 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 a 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 medicament container assembly coupled to a needle, the medicament container assembly including a first plunger and a second plunger, the first plunger defining, at least in part, a first volume containing a first substance, the second plunger defining, at least in part, a second volume containing a second substance;

a movable assembly including 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 a first configuration to a second configuration, a distal end portion of the second movable member configured to move the second plunger within the medicament container assembly when the movable assembly is changed from the first configuration to the second configuration, the first movable member configured to move the first plunger within the medicament container assembly to expel at least at least a portion of the first substance and the second substance via the needle; and

a retraction mechanism configured to retract the needle, a release portion of the first movable member configured to contact the second movable member after the first movable member moves the first plunger to enable the retraction mechanism to retract the needle.

2. The apparatus of claim 1, wherein at least one of the first substance or the second substance includes a substantially dry glucagon.

3. The apparatus of claim 1, wherein a portion of the second movable member is slidably disposed within the first movable member.

4. The apparatus of claim 1, wherein:

the release portion of the first movable member is a flexible portion configured to be deformed by the second movable member to enable the retraction mechanism.

5. The apparatus of claim 1 , wherein:

the first movable member is operatively coupled to a first spring configured to urge the first movable member to move the first plunger; and

the second movable member is operatively coupled to a second spring configured to produce a force to move the second movable member relative to the first movable member.

6. The apparatus of claim 1, further comprising:

an actuator assembly configured to initiate a movement of the first movable member, the actuator assembly including a release member, a longitudinal axis of the release member being offset from a longitudinal axis of the medicament container assembly.

7. The apparatus of claim 1, further comprising:

an actuator assembly configured to initiate movement of the second movable member, the actuator assembly including a release member configured to rotate.

8. The apparatus of claim 1, further comprising:

a spring configured to exert a force on the second movable member to move the second movable member relative to the first movable member when the spring is released; and

an actuation member configured to be rotated to release the spring.

9. The apparatus of claim 1, wherein:

the first movable member is configured to move the first plunger in a first direction; and

the retraction mechanism includes a spring configured to retract the needle in a second direction, the second direction opposite the first direction.

10. The apparatus of claim 1, wherein the medicament container assembly is configured such that the first substance is mixed with the second substance when the movable assembly is changed from the first configuration to the second configuration.

11. An apparatus, comprising:

a medicament container assembly coupled to a needle, the medicament container assembly including a first plunger and a second plunger, the first plunger defining, at least in part, a first volume, the second plunger 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 relative to the first movable member to move the second plunger within the medicament container assembly, the first movable member including a release portion configured to move between a first configuration and a second configuration, the first movable member configured to move the first plunger in a first direction within the medicament container assembly to expel at least a portion of a contents of the first volume and the second volume via the needle; and

a spring configured to move the needle in a second direction opposite the first direction when the spring moves from a compressed configuration to an expanded configuration, the release portion of the first movable member configured to limit movement of the spring from the compressed configuration to the expanded configuration when the release portion is in its first configuration, the release portion of the first movable member configured to be moved from its first configuration to its second configuration by a portion of the second movable member.

12. The apparatus of claim 11, wherein the first movable member is configured to be actuated independently from the second movable member.

13. The apparatus of claim 11, further comprising:

a first energy storage member configured to produce a first force to move the first movable member; and

a second energy storage member configured to produce a second force to move the second movable member, the second energy storage member different than the first energy storage member.

14. The apparatus of claim 11, wherein a portion of the second movable member is slidably disposed within the first movable member.

15. The apparatus of claim 11, further comprising:

a spring configured to produce a force to move the second movable member relative to the first movable member; and

a release member configured to release the spring when the release member is rotated.

16. The apparatus of claim 11, wherein the release portion of the first movable member is configured to be moved from its first configuration to its second configuration after the first movable member moves the first plunger.

17. The apparatus of claim 11, wherein the release portion of the first movable member enables the spring to move from the compressed configuration to the expanded configuration when contacted by the portion of the second movable member.

18. The apparatus of claim 11, wherein the release portion of the first movable member is configured to deform when moved from its first configuration to its second configuration.

19. The apparatus of claim 11, wherein the release portion of the first movable member is a flexible portion.

20. The apparatus of claim 11, wherein:

the first volume contains a first substance;

the second volume contains a second substance; and

the medicament container assembly is configured such that the first substance is mixed with the second substance when the second movable member is moved relative to the first movable member.

21. An apparatus, comprising:

a medicament container assembly coupled to a needle, the medicament container assembly including a first plunger and a second plunger, the first plunger defining, at least in part, a first volume, the second plunger 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 relative to the first movable member to move the second plunger within the medicament container assembly, the medicament container assembly configured such that the second volume is placed in fluid communication with the first volume when the second plunger is moved within the medicament container assembly, the first movable member configured to move the first plunger in a first direction within the medicament container assembly to expel at least a portion of a contents of the first volume and the second volume via the needle;

a first spring configured to produce a force to move the second movable member relative to the first movable member; and

a second spring configured to move the needle in a second direction opposite the first direction when the second spring moves from a compressed configuration to an expanded configuration, the first movable member including a release member configured to contact the second movable member to enable the second spring to move from the compressed configuration to the expanded configuration.

22. The apparatus of claim 21 further comprising:

an actuator configured to release the first spring when the actuator is rotated.

23. The apparatus of claim 21, wherein the first movable member is configured to be actuated independently from the second movable member.

24. The apparatus of claim 21, wherein the release member of the first movable member is configured to deform when in contact with the second movable member.

25. The apparatus of claim 21, wherein:

the first volume contains a first substance;

the second volume contains a second substance; and

the medicament container assembly is configured such that the first substance is mixed with the second substance when the second movable member is moved relative to the first movable member.