Devices, systems and methods for medicament delivery

• US 7,648,483 B2
• Filed: 06/05/2007
• Issued: 01/19/2010
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Meyers, Paul F., Edwards, Eric Shawn, Licata, Mark J., Edwards, Evan Thomas
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US11/758,393
• Publication Number:
  US 20070239114A1
• Time in Patent Office: 959 Days
• Field of Search: 604/131, 604/63, 604140-147
• US Class Current: 604/140
• 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 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• 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 2207/00 Methods of manufacture, assembly or production
• 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 5/24 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 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31565 : Administration mechanisms, i.e. constructional features, modes of administering a dose dosing mechanisms for setting a dose A61M5/31533
• CPC Class Codes: A61M 5/31591 : Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: A61M 5/3202 : Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• 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: B65B 3/003 : Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/02 : Sterilising, e.g. of complete packages
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Apparatuses for automatic medicament injection and methods for manufacturing automatic medicament injectors are described herein. In some embodiments, an apparatus includes a housing, a needle, an energy storage member, an actuator, a locking member, and a needle guard. The needle is configured to move between a first position and a second position. In its first position, the needle is contained within the housing. In its second position, at least a portion of the needle extends from the housing. The energy storage member has a first configuration and a second configuration and is configured to produce a force when moving between its first configuration and its second configuration to move the needle from its first position to its second position. The actuator is configured to move the energy storage member from its first configuration to its second configuration. The locking member is movably coupled to the distal end portion of the housing such that the locking member can be moved between a first position and a second position. In its first position, the locking member is configured to engage the actuator to prevent the actuator from moving the energy storage member to the second configuration. The needle guard is removably coupled to at least one of the distal end portion of the housing or a base movably coupled to the distal end portion of the housing.

Claims

1. An apparatus, comprising:

a housing having a distal end portion and a proximal end portion;

a needle configured to move between a first position and a second position, in the first position the needle is contained within the housing, in the second position at least a portion of the needle extends from the distal end portion of the housing;

an energy storage member having a first configuration and a second configuration, the energy storage member configured to produce a force when moved between its first configuration and its second configuration to move the needle from its first position to its second position;

an actuator configured to move the energy storage member from its first configuration to its second configuration, the actuator including a first actuation member disposed within the housing and a second actuation member coupled to the distal end portion of the housing; and

a locking member configured to be movably coupled to the distal end portion of the housing such that the locking member can be moved between a first position and a second position, the locking member including a protrusion configured to extend through an opening defined by the second actuation member and engage a portion of the first actuation member when the locking member is in its first position to prevent the actuator from moving the energy storage member to the second configuration.

2. The apparatus of claim 1, wherein the locking member includes a needle guard configured to receive the needle when the needle is in its first position.

3. The apparatus of claim 1, wherein:

the opening defined by the second actuation member is a first opening; and

the locking member includes a needle guard coupled to the locking member such that a portion of the needle guard is disposed through a second opening defined by the second actuation member and about the needle when the locking member is in its first position.

4. The apparatus of claim 1, wherein the locking member is removed from the housing when the locking member is in its second position.

5. The apparatus of claim 1, wherein the locking member has two extended portions configured to be disposed about a portion of the second actuation member when the locking member is in its first position.

6. The apparatus of claim 5, wherein at least one of the extended portions is matingly received within a recess defined by the second actuation member when the locking member is in its first position.

7. The apparatus of claim 1, wherein:

the first actuation member is an actuation rod having a plurality of projections; and

the protrusion of the locking member is configured to extend between the plurality of projections of the actuation rod when the locking member is in its first position.

8. The apparatus of claim 1, wherein the locking member is configured to move along an axis normal to a longitudinal axis of the needle.

9. The apparatus of claim 1, wherein the locking member includes a needle guard, at least a portion of the needle guard is constructed from a substantially impermeable microbial barrier and configured to allow a sterilant gas to pass therethrough.

10. The apparatus of claim 1, further comprising a sleeve having a first position and a second position, the sleeve being configured to cover at least a portion of the housing when the sleeve is in its first position, the sleeve being configured to be removed from the housing when the sleeve is in its second position.

11. The apparatus of claim 1, wherein the actuator includes a biasing member coupled to the first actuation member, the biasing member configured to urge the energy storage member towards the second configuration when the biasing member is released;

and

the second actuation member is configured to release the biasing member when the second actuation member is moved relative to the housing.

12. The apparatus of claim 1, wherein the force produced by the energy storage member is a first force, the apparatus further comprising:

a retraction spring configured to produce a second force to move the needle in a proximal direction from its second position to a third position.

13. The apparatus of claim 1, wherein the energy storage member is a gas container configured to contain a pressurized gas.

14. An apparatus, comprising:

a housing;

a medicament injector movably disposed within the housing, the medicament injector including a medicament container and a needle;

an energy storage member configured to produce a force to move the medicament injector such that a portion of the needle is disposed through a distal end surface of the housing at a first location when the energy storage member is moved from a first configuration to a second configuration;

an actuator coupled to the distal end portion of the housing, the actuator configured to move the energy storage member from the first configuration to the second configuration when the actuator is moved relative to the housing, the actuator having a substantially planar surface configured to engage a body; and

a locking member configured to be movably coupled to the distal end portion of the housing between a first position and a second position, the locking member including a protrusion configured to extend through the distal end surface of the housing at a second location such that the protrusion engages a portion of an actuation rod within the housing to limit movement of the actuator relative to the housing when the locking member is in its first position.

15. The apparatus of claim 14, wherein the locking member includes a needle guard spaced apart from the protrusion, the needle guard configured to be disposed about the needle when the locking member is in its first position.

16. The apparatus of claim 14, wherein the locking member includes a needle guard spaced apart from the protrusion, the needle guard configured to be disposed about the needle when the locking member is in its first position, the needle guard constructed from a substantially rigid material configured to substantially prevent microbes from passing therethrough, the substantially rigid material configured to allow a sterilant gas to pass therethrough.

17. The apparatus of claim 14, wherein the locking member is configured to be removed from the distal end portion of the housing in a direction substantially parallel to a longitudinal axis of the needle.

18. The apparatus of claim 14, wherein a width of the surface of the actuator is substantially the same as a width of the housing, the actuator configured to move proximally relative to the housing when the surface is pressed against the body.

19. The apparatus of claim 14, wherein:

the surface of the actuator defines first opening through which the needle is disposed when the portion of the needle is disposed through the opening defined by the distal end surface of the housing; and

a second opening through which the protrusion of the locking member is disposed when the locking member is in its first position.

20. The apparatus of claim 14, wherein:

the energy storage member is configured to move proximally within the housing when the energy storage member is moved from the first configuration to the second configuration; and

the medicament injector is configured to move distally within the housing in response to the force produced by the energy storage member.

21. The apparatus of claim 14, wherein the energy storage member is a gas container configured to contain a pressurized gas.

22. The apparatus of claim 14, wherein:

the actuator is configured to deform a portion of the actuation rod to move the energy storage member from the first configuration to the second configuration when the actuator is moved relative to the housing; and

the protrusion of the locking member is configured to engage the actuation rod such that deformation of the portion of the actuation rod is inhibited when the locking member is in the first position.

23. The apparatus of claim 14, wherein:

the portion of the needle extends through the distal end surface of the housing via a first opening defined by the housing; and

the protrusion of the locking member extends through the distal end surface of the housing via a second opening defined by the housing.

24. An apparatus, comprising:

a housing;

a medicament injector movably disposed within the housing, the medicament injector including a medicament container and a needle;

a system actuator disposed within the housing, the system actuator configured to move the medicament injector within the housing when the system actuator is moved from a first configuration to a second configuration, the system actuator including;

a gas container configured to contain a pressurized gas;

a puncturer having a portion disposed apart from the gas container when the system actuator is in the first configuration, the portion being disposed within the gas container when the system actuator is in the second configuration; and

a biasing member configured to urge the system actuator towards the second configuration when the biasing member is released;

a base coupled to a distal end portion of the housing, the base configured to release the biasing member when the base is moved relative to the housing; and

a safety lock movably coupled to the distal end portion of the housing, the safety lock configured to limit movement of the base relative to the housing when the safety lock is in a first position, the base configured to move relative to the housing when the safety lock is in a second position.

25. The apparatus of claim 24, wherein the safety lock includes a needle guard configured to be disposed about the needle when the safety lock is in its first position.

26. The apparatus of claim 24, wherein the safety lock is configured to remove a needle guard from about the needle when the safety lock is moved from its first position to its second position.

27. The apparatus of claim 24, wherein the base includes a substantially planar surface configured to engage a body, the surface defining an opening through which a portion of the needle is disposed in response to the system actuator being moved from the first configuration to the second configuration.

28. The apparatus of claim 24, wherein:

the gas container is configured to move proximally within the housing when the system actuator is moved from the first configuration to the second configuration; and

the medicament injector is configured to move distally within the housing in response to a force produced by the system actuator.

29. The apparatus of claim 24, wherein

the base is configured to deform a portion of an actuation rod to move the system actuator from the first configuration to the second configuration when the base is moved relative to the housing;

and

the safety lock includes a protrusion configured to engage the actuation rod such that deformation of the portion of the actuation rod is inhibited when the safety lock is in the first position.

30. The apparatus of claim 24, wherein the system actuator is configured to move the medicament injector within the housing in a distal direction, the apparatus further comprising:

a retraction spring configured to produce a force to move the medicament injector in a proximal direction such that the portion of the needle is disposed within the distal end portion of the housing.

31. An apparatus, comprising:

a housing;

a medicament injector movably disposed within the housing, the medicament injector including a medicament container and a needle;

an energy storage system disposed within the housing, the energy storage system configured to produce a first force to move the medicament injector in a distal direction such that a portion of the needle is disposed outside of a distal end portion of the housing when the energy storage system is moved from a first configuration to a second configuration;

an actuator coupled to the distal end portion of the housing, the actuator configured to move the energy storage system from the first configuration to the second configuration when the actuator is moved relative to the housing;

a locking member configured to be movably coupled to the distal end portion of the housing between a first position and a second position, the locking member configured to limit movement of the actuator relative to the housing when the locking member is in its first position; and

a retraction spring configured to produce a second force to move the medicament injector in a proximal direction such that the portion of the needle is disposed within the distal end portion of the housing.

32. The apparatus of claim 31, wherein the locking member includes a needle guard configured to be disposed about the needle when the locking member is in its first position.

33. The apparatus of claim 31, wherein the actuator defines an opening through which the needle is disposed when the portion of the needle is disposed outside of the distal end portion of the housing.

34. The apparatus of claim 31, wherein:

the energy storage system includes a portion configured to move proximally within the housing when the energy storage system is moved from the first configuration to the second configuration; and

the medicament injector is configured to move distally within the housing in response to the force produced by the energy storage system.

35. The apparatus of claim 31, wherein the energy storage system includes a gas container configured to contain a pressurized gas.

36. The apparatus of claim 31, wherein:

the actuator is configured to deform a portion of an actuation rod to move the energy storage system from the first configuration to the second configuration when the actuator is moved relative to the housing; and

the locking member includes a protrusion configured to engage the actuation rod such that deformation of the portion of the actuation rod is inhibited when the locking member is in the first position.

37. The apparatus of claim 31, wherein:

a portion of the needle is disposed through an opening defined by a distal end surface of the housing at a first location in response to the first force; and

the locking member includes a protrusion configured to extend through the distal end surface of the housing at a second location such that the protrusion engages a portion of an actuation rod within the housing when the locking member is in its first position.