DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY

• US 20070239114A1
• Filed: 06/05/2007
• Published: 10/11/2007
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Meyers, Paul, Edwards, Eric, Licata, Mark, Edwards, Evan
• Granted Patent: US 7,648,483 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• 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 housing;

an energy storage member having a first configuration and a second configuration, the energy storage member 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;

an actuator configured to move the energy storage member from its first configuration to its second configuration;

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, when the locking member is 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; and

a needle guard removably coupled to the distal end portion of the housing.

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

3. The apparatus of claim 1, wherein the needle guard includes a sheath configured to receive the needle and a sheath retainer configured to retain the sheath within the housing.

4. The apparatus of claim 1, wherein the needle guard includes a sheath having a proximal end portion and a distal end portion, the sheath defining an opening configured to receive at least a portion of the needle.

5. The apparatus of claim 1, wherein the needle guard includes a sheath configured to receive the needle, the sheath being constructed from a rigid material.

6. The apparatus of claim 1, wherein the needle guard includes a sheath having a proximal end portion and a distal end portion, the sheath defining an opening configured to receive at least a portion of the needle, the sheath defining a recessed portion within the opening, the recessed portion configured to engage a corresponding protrusion on a needle hub coupled to the needle, the needle hub being disposed within the housing.

7. The apparatus of claim 1, wherein the needle guard includes a sheath and a sheath retainer, the sheath retainer having a proximal portion and a distal portion, the proximal portion including at least one protrusion configured to engage at least one corresponding recess on at least one of the distal end portion of the housing or a base movably coupled to the distal end portion of the housing, at least a portion of the sheath disposable within an opening defined by the distal portion of the sheath retainer.

8. The apparatus of claim 1, wherein the needle guard includes a sheath retainer configured to be coupled to the housing, the sheath retainer configured to at least partially cover the locking member and inhibit movement of the locking member when the sheath retainer is coupled to the housing.

9. The apparatus of claim 1, wherein:

the actuator includes a movable actuation member; and

the locking member is configured to prevent movement of the movable actuation member when the locking member is in its first position.

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

11. The apparatus of claim 1, wherein the locking member has a first end and a second end, the second end including two extended portions configured to be disposed about a portion of the actuator when the locking member is in its first position, at least one of the extended portions including an inwardly facing protrusion, the inwardly facing protrusion configured to engage at least one of the distal end portion of the housing or a base movably coupled to the distal end portion of the housing.

12. The apparatus of claim 11, wherein at least one of the extended portions defines a recess configured to receive a portion of the needle guard when the needle guard is coupled to the distal end portion of the housing.

13. The apparatus of claim 11, wherein:

the actuator includes an actuation rod having a plurality of projections; and

the first end of the locking member includes an inwardly extending locking protrusion configured to extend between the plurality of projections of the actuation rod, the locking protrusion configured to inhibit actuation of the actuator when the locking member is in its first position.

14. The apparatus of claim 11, wherein:

the actuator includes an actuation rod having a plurality of projections; and

the first end of the locking member includes an inwardly extending locking protrusion configured to extend between the plurality of projections of the actuation rod, the locking protrusion configured to prevent the plurality of projections from moving inwardly towards each other.

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

16. The apparatus of claim 1, wherein the needle guard is configured to engage the locking member to inhibit movement of the locking member from its first position to its second position when the needle guard is coupled to the distal end portion of the housing.

17. The apparatus of claim 1, wherein the needle guard includes an inner member configured to substantially cover at least a portion of the needle and an outer member configured to be coupled to the inner member and the distal end portion of the housing, the inner member being a substantially impermeable microbial barrier and configured to allow a sterilant gas to pass therethrough.

18. The apparatus of claim 1, wherein at least a portion of the needle guard is substantially impermeable to microbial penetration and is configured to allow a sterilant gas to pass therethrough.

19. The apparatus of claim 1, wherein the needle guard is configured to substantially cover the locking member.

20. 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.

21. An apparatus, comprising:

a housing; and

a safety guard including a locking portion and a needle guard portion, the locking portion configured to inhibit actuation of a medicament delivery device, the needle guard portion configured to substantially cover a needle of the medicament delivery device, the safety guard having a first position in which the safety guard is configured to be selectively coupled to at least one of the housing or a base movably coupled to the housing and a second position in which the safety guard is removed from the housing.

22. The apparatus of claim 21, wherein the needle guard portion includes a sheath and a sheath retaining portion, the sheath defining an opening configured to receive at least a portion of the needle, the sheath being removably couplable to the sheath retaining portion, the sheath retaining portion being configured to be coupled to the housing.

23. The apparatus of claim 21, wherein the needle guard portion includes a sheath and a sheath retaining portion, the sheath defining an opening configured to receive at least a portion of the needle, the sheath being removably couplable to the sheath retaining portion, the sheath retaining portion being configured to be coupled to the housing, the sheath being constructed from a rigid material.

24. The apparatus of claim 21, wherein the safety guard includes a base portion, the locking portion being a protrusion extending from the base portion of the safety guard.

25. The apparatus of claim 21, wherein the safety guard includes a base portion, wherein the locking portion includes a protrusion extending proximally from the base, the protrusion being configured to extend between a plurality of projections of an actuator of the medicament delivery device when the safety guard is in its first position.

26. The apparatus of claim 21, wherein the safety guard includes a base portion, the base portion having a first end and a second end, the locking portion being disposed on the first end and including a first engagement portion, the base portion including a second engagement portion disposed on the second end and configured to be selectively coupled to at least a portion of the housing when the safety guard is in its first position.

27. The apparatus of claim 21, wherein the needle guard portion includes a sheath, the sheath being a substantially impermeable microbial barrier and being configured to allow a sterilant gas to pass therethrough.

28. The apparatus of claim 21, further comprising a distal end cap configured to selectively engage the housing, the distal end cap configured to substantially cover at least a portion of the safety guard when the distal end cap is engaged with the housing.

29. The apparatus of claim 21, further comprising a distal end cap having a first position in which the distal end cap is removably coupled to a distal end portion of the housing and in which the distal end cap is configured to substantially cover the safety guard, and a second position in which the distal end cap is removed from the housing.

30. An apparatus, comprising:

a needle guard configured to cover at least a portion of a needle of a medical injector, the needle guard configured to substantially prevent microbes from passing therethrough, the needle guard configured to allow a sterilant gas to pass therethrough.

31. The apparatus of claim 30, wherein the needle guard is porous.

32. The apparatus of claim 30, wherein the needle guard is rigid.

33. The apparatus of claim 30, wherein the needle guard is constructed from at least one polymer or elastomer.

34. The apparatus of claim 30, wherein the needle guard is constructed from at least one of polyethylene, high density polyethylene, polypropylene, polytetrafluoroethylene, thermoplastic polyurethane, rubber, or an elastomer.

35. The apparatus of claim 30, wherein the needle guard includes a valve configured to allow sterilant gas to pass therethrough.

36. An apparatus, comprising:

a housing;

a medicament injector disposable within the housing, the medicament injector including a needle having 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 housing; and

a porous needle guard removably coupled to the distal end portion of the housing, the porous needle guard being constructed from a microbial resistant material.

37. The apparatus of claim 36, wherein the porous needle guard includes at least one protrusion configured to engage a corresponding recess in the housing.

38. The apparatus of claim 36, wherein the porous needle guard includes at least one recess configured to receive a corresponding protrusion of at least one of the housing or the medicament injector.

39. The apparatus of claim 36, wherein the porous needle guard is constructed from at least one of polyethylene, high density polyethylene, polypropylene, polytetrafluoroethylene, thermoplastic polyurethane, rubber, or an elastomer.

40. A method, comprising:

inserting at least a portion of a needle into a needle hub disposed in a housing;

installing a needle cover over at least a portion of the needle to substantially cover a portion of the needle extending from the needle hub; and

sterilizing the needle after installing the needle cover.

41. The method of claim 40, wherein at least one of the inserting at least a portion of a needle into a needle hub and the installing a needle cover is performed in a non-sterilized environment.

42. The method of claim 40, wherein the sterilizing the needle includes using a gas sterilization technique.

43. The method of claim 40, wherein the sterilizing the needle includes conveying a sterilant gas through a portion of the needle cover.

44. The method of claim 40, wherein the installing a needle cover includes installing a porous needle cover over at least a portion of the needle.

45. The method of claim 40, wherein the sterilizing of the needle includes using a gas sterilization technique operative to penetrate one or more pores of the needle cover.

46. The method of claim 40, wherein sterilizing the needle includes using a sterilization technique including at least one of ethylene oxide, gamma radiation, e-beam radiation, ultraviolet radiation, steam, plasma, or hydrogen peroxide.

47. The method of claim 40, wherein the installing a needle cover includes installing a needle cover constructed of at least one of polyethylene, high density polyethylene, polypropylene, polytetrafluoroethylene, thermoplastic polyurethane, rubber, or an elastomer.

48. The method of claim 40, further comprising:

disposing a medicament container in the housing, the medicament container containing a predetermined amount of a medicament.

49. The method of claim 40, further comprising:

disposing a medicament container in the housing, the medicament container containing a predetermined amount of epinephrine.