Devices, systems and methods for medicament delivery

• US 10,314,977 B2
• Filed: 09/06/2017
• Issued: 06/11/2019
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T.
• Primary Examiner(s): Patel, Shefali D
• Application Number:
  US15/696,287
• Publication Number:
  US 20180008774A1
• Time in Patent Office: 643 Days
• Field of Search: 604131-155, 604506
• 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 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/8218 Gas operated
• 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 5/31501 Means for blocking or restricting the movement of the rod or piston A61M5/5013 takes precedence
• 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

Abstract

An apparatus includes a housing, a medicament container, an actuator, and a biasing member. The actuator is configured to move the medicament container within the housing when the actuator is moved from a first configuration to a second configuration. The actuator includes a gas container and a puncturer. When the actuator is in the first configuration, a portion of the puncturer is disposed apart from the gas container. When the actuator is in the second configuration, the portion of the puncturer is disposed within the gas container. The gas container has a longitudinal axis offset from a longitudinal axis of the medicament container. The biasing member is configured to bias the actuator toward the second configuration.

Claims

1. An apparatus, comprising:

a housing;

a medicament container disposed within the housing;

an actuator coupled to an end portion of the housing, the actuator configured to move between a first actuator position and a second actuator position;

a plunger having a first plunger end portion and a second plunger end portion, the first plunger end portion configured to move in response to the movement of the actuator to move the second plunger end portion within the medicament container from a first plunger position to a second plunger position;

a medicament container interface disposed within the housing, the medicament container interface coupled to the medicament container and having a portion extending distally beyond a proximal end of the medicament container, the medicament container interface including an end stop surface configured to limit movement of the plunger in a distal direction, the end stop surface between the first plunger end portion and the second plunger end portion; and

a stop member disposed within the housing distally from the end stop surface, the stop member configured to interfere with the medicament container interface to limit movement of the medicament container interface within the housing.

2. The apparatus of claim 1, wherein the medicament container is configured to move within the housing, the apparatus further comprising:

a biasing member configured to urge the medicament container in a proximal direction.

3. The apparatus of claim 2, further comprising:

a spring stop within the housing,

the biasing member is a spring, a distal end portion of the spring engaging the spring stop.

4. The apparatus of claim 1, wherein:

the medicament container includes a single dose of a medicament; and

the second plunger end portion includes a resilient member configured to expel the medicament when the second plunger end portion moves from the first plunger position to the second plunger position.

5. The apparatus of claim 4, wherein the medicament includes epinephrine.

6. The apparatus of claim 1, wherein:

the housing defines a status window; and

contents of the medicament container are viewable through the status window when the second plunger end portion is in the first plunger position.

7. The apparatus of claim 6, further comprising:

an indicator configured to move with the plunger within the housing between a first indicator position and a second indicator position, the indicator being viewable through the status window when the second plunger end portion is in the second plunger position and the indicator is in the second indicator position.

8. The apparatus of claim 7, wherein the indicator exposes a colored portion to provide a visual indication when the indicator is in the second indicator position.

9. The apparatus of claim 1, wherein the medicament container is in fluid communication with a needle, a portion of the needle being disposed through an opening defined by a distal end portion of the housing and outside of the distal end portion of the housing, the apparatus further comprising:

a needle sheath covering the needle, the needle sheath configured to maintain sterility of the needle.

10. The apparatus of claim 1, wherein a central portion of the plunger is configured to move within the medicament container interface when the second plunger end portion is moved within the medicament container from the first plunger position to the second plunger position, the central portion between the first plunger end portion and the second plunger end portion.

11. The apparatus of claim 1, further comprising:

an energy storage member configured to produce a force in response to the movement of the actuator;

the energy storage member being operably coupled to the plunger such that the force is exerted on the first plunger end portion to cause the second plunger end portion to move from the first plunger position to the second plunger position.

12. The apparatus of claim 11, wherein the energy storage member is configured to produce a pressurized gas, the apparatus further comprising:

a valve configured to release the pressurized gas, the end stop surface of the medicament container interface configured to engage the valve after a portion of a medicament has been delivered from the medicament container.

13. The apparatus of claim 1, wherein the medicament container and the medicament container interface are configured to move together within the housing, the apparatus further comprising:

a biasing member configured to urge the medicament container and the medicament container interface in a proximal direction.

14. The apparatus of claim 1, wherein:

the medicament container includes a proximal edge that defines a proximal opening through which a portion of the plunger is disposed; and

a proximal portion of the medicament container interface is outside of the medicament container between the first plunger end portion and the proximal edge of the medicament container, the end stop surface being within the proximal portion of the medicament container interface.

15. An apparatus, comprising:

a housing having a distal end portion defining an opening, a spring stop being within the housing;

a medicament container configured to move within the housing in a distal direction from a first container position to a second container position;

a needle in fluid communication with the medicament container, a portion of the needle being disposed through the opening and outside of the distal end portion of the housing;

a needle sheath covering the needle, the needle sheath configured to maintain sterility of the needle;

an actuator coupled to the housing, the actuator configured to move from a first actuator position to a second actuator position;

a plunger having a first plunger end portion and a second plunger end portion, the first plunger end portion configured to move in the distal direction in response to the movement of the actuator to move the second plunger end portion within the medicament container from a first plunger position to a second plunger position;

a spring having a distal end portion engaging the spring stop, the spring configured to urge the medicament container in a proximal direction;

a medicament container interface coupled to the medicament container, the medicament container interface including an end stop surface configured to limit movement of the plunger in the distal direction; and

a stop member disposed within the housing distally from the end stop surface, the stop member configured to directly contact the medicament container interface to limit movement of the medicament container interface within the housing.

16. The apparatus of claim 15, wherein:

the medicament container includes a dose of a medicament;

the second plunger end portion is in contact with a resilient member configured to expel the medicament when the second plunger end portion moves from the first plunger position to the second plunger position; and

the spring is configured to urge the medicament container in the proximal direction when the medicament is being expelled.

17. The apparatus of claim 16, wherein the medicament includes epinephrine.

18. The apparatus of claim 15, wherein:

the housing defines a status window; and

contents of the medicament container are viewable through the status window when the second plunger end portion is in the first plunger position.

19. The apparatus of claim 18, further comprising:

an indicator configured to move with the plunger within the housing between a first indicator position and a second indicator position, the indicator being viewable through the status window when the second plunger end portion is in the second plunger position and the indicator is in the second indicator position.

20. The apparatus of claim 15, further comprising:

a central portion of the plunger configured to move within the medicament container interface when the second plunger end portion is moved within the medicament container from the first plunger position to the second plunger position.

21. The apparatus of claim 15, further comprising:

an energy storage member configured to produce a force;

the energy storage member being operably coupled to the plunger such that the force is exerted on the first plunger end portion to cause the plunger to move from the first plunger position to the second plunger position.

22. The apparatus of claim 21, wherein the energy storage member is configured to produce a pressurized gas, the apparatus further comprising:

a valve configured to release the pressurized gas, the end stop surface of the medicament container interface configured to engage the valve after a portion of a medicament has been delivered from the medicament container.

23. An apparatus, comprising:

a housing;

a medicament container within the housing, the medicament container containing a dose of a medicament;

a needle coupled to the medicament container, a portion of the needle configured to be disposed outside of a distal end portion of the housing;

a needle sheath covering the needle, the needle sheath configured to maintain sterility of the needle;

an actuator coupled to the housing, the actuator configured to move between a first actuator position and a second actuator position;

a plunger having a first plunger end portion and a second plunger end portion, the first plunger end portion configured to move in response to the movement of the actuator to move the second plunger end portion within the medicament container from a first plunger position to a second plunger position to convey the dose of the medicament from the medicament container through the needle;

a medicament container interface disposed within the housing, the medicament container interface coupled to the medicament container and having a portion extending distally beyond a proximal end of the medicament container, the medicament container interface including an end stop surface between the first plunger end portion and the second plunger end portion, the end stop surface configured to limit movement of the plunger when the second plunger end portion reaches the second plunger position, thereby limiting an amount of the medicament to be conveyed; and

a stop member disposed within the housing distally from the end stop surface, the stop member configured to interfere with the medicament container interface to limit movement of the medicament container interface within the housing.

24. The apparatus of claim 23, wherein the dose of the medicament is a single dose of epinephrine.

25. The apparatus of claim 23, further comprising:

an energy storage member configured to produce a force;

the energy storage member being operably coupled to the plunger such that the force is exerted on the first plunger end portion to cause the plunger to move from the first plunger position to the second plunger position.

26. The apparatus of claim 23, wherein a central portion of the plunger is configured to move within the medicament container interface when the second plunger end portion is moved within the medicament container from the first plunger position to the second plunger position.

27. The apparatus of claim 23, the apparatus further comprising:

a biasing member configured to urge the medicament container in a proximal direction.

28. The apparatus of claim 27, wherein the biasing member is a spring, a distal end portion of the spring engaging a spring stop within the housing.