Devices, systems and methods for medicament delivery

• US 9,737,669 B2
• Filed: 06/04/2015
• Issued: 08/22/2017
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US14/731,048
• Publication Number:
  US 20160015907A1
• Time in Patent Office: 810 Days
• Field of Search: 604131, 604134-136, 604140, 604141, 604143, 604144, 604156, 604157, 604192
• 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 needle position and a second needle position, in the first needle position the needle is contained within the housing, in the second needle position at least a portion of the needle extends from the distal end portion of the housing;

an energy storage member within the housing, the energy storage member configured to produce a force to move the needle from the first needle position to the second needle position;

a base coupled to the distal end portion of the housing, the base configured to actuate the energy storage member when the base is moved relative to the housing, the base defining an opening through which the needle is disposed when the needle is in the second needle position; and

a safety lock moveably coupled to the distal end portion of the housing such that the safety lock moves in a direction nonparallel to a longitudinal axis of the needle between a first safety lock position and a second safety lock position, the safety lock configured to prevent movement of the base when the safety lock is in the first safety lock position.

2. The apparatus of claim 1, wherein the safety lock is removed from the housing when the safety lock is in the second safety lock position.

3. The apparatus of claim 1, wherein the safety lock is moved from the first safety lock position to the second safety lock position by moving the safety lock in the direction, the direction being normal to the longitudinal axis of the needle.

4. The apparatus of claim 1, wherein the safety lock has a first end and a second end, the second end having an extended portion that includes a protrusion, the protrusion configured to engage a portion of the housing to couple the safety lock to the housing in the first safety lock position.

5. The apparatus of claim 4, wherein:

the extended portion is a first extended portion;

the protrusion is a first protrusion;

the portion of the housing is a first portion of the housing; and

the safety lock includes a second extended portion having a second protrusion, the second protrusion configured figured to engage a second portion of the housing to couple the safety the first safety lock position.

6. The apparatus of claim 1, wherein an outer surface of the safety lock includes an indicium to instruct a user in removing the safety lock, the indicium including at least one of a numeral or an arrow.

7. The apparatus of claim 1, wherein the safety lock is located between a shoulder of the housing and a shoulder of the base when the safety lock is in the first safety lock position.

8. The apparatus of claim 1, further comprising:

a cover configured to encompass the distal end portion of the housing including the safety lock and the base, the cover configured to be removed prior to movement of the safety lock.

9. The apparatus of claim 1, further comprising:

a medicament container within the housing, the medicament container configured to be fluidically coupled to the needle when the needle is in the second needle position, the medicament container containing epinephrine.

10. The apparatus of claim 1, wherein the longitudinal axis of the needle is noncoaxial to a longitudinal axis of the energy storage member.

11. An apparatus, comprising:

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

a medicament container disposed within the housing;

an energy storage member disposed within the housing, the energy storage member configured to produce a force to move the medicament container to an injection position;

a needle fluidically coupled to the medicament container when the medicament container is in the injection position, a distal end of the needle extending from the distal end portion of the housing when the medicament container is in the injection position;

a base movably coupled to the distal end portion of the housing, the base defining an opening through which the needle is disposed when the medicament container is in the injection position; and

a safety lock moveably coupled to the distal end portion of the housing, the safety lock having an elongated portion disposed between a shoulder of the housing and a shoulder of the base to prevent movement of the base when the safety lock is in a first position, the elongated portion removed from between the shoulder of the housing and the shoulder of the base when the safety lock is in a second position.

12. The apparatus of claim 11, wherein the elongated portion includes a protrusion, the protrusion configured to engage a portion of the housing to couple the safety lock to the housing in the first position.

13. The apparatus of claim 12, wherein:

the elongated portion is a first elongated portion;

the protrusion is a first protrusion;

the portion of the housing is a first portion of the housing; and

the safety lock includes a second elongated portion having a second protrusion, the second protrusion configured to engage a second portion of the housing to couple the safety lock in the first position.

14. The apparatus of claim 11, wherein the safety lock can be moved between the first position and the second position by moving the safety lock in a direction normal to a longitudinal axis of the needle.

15. The apparatus of claim 11, wherein the safety lock is removed from the housing when the safety lock is in the second position.

16. The apparatus of claim 11, wherein an outer surface of the safety lock includes an indicium to instruct a user in removing the safety lock, the indicium including at least one of a numeral or an arrow.

17. The apparatus of claim 11, further comprising:

a cover configured to encompass the distal end portion of the housing including the safety lock and the base, the cover configured to be removed prior to movement of the safety lock.

18. The apparatus of claim 11, wherein the medicament container contains epinephrine.

19. An apparatus, comprising:

a housing;

a medicament container disposed within the housing;

an energy storage member disposed within the housing, the energy storage member configured to produce a force to move the meth saner from a first container position to a second container position;

a needle fluidically coupled to the medicament container when the medicament container is in the second container position, a portion of the needle extending from a distal end portion of the housing when the medicament container is in the second container position;

a base movably coupled to the distal end portion of the housing, the base defining an opening through which the needle is disposed when the medicament container is in the second container position;

a safety lock moveably coupled to the distal end portion of the housing, the safety lock in contact with the base to limit movement of the base when the safety lock is in a first position, the safety lock spaced apart from the base when the safety lock is in a second position; and

a cover removably coupled to the distal end portion of the housing, the cover surrounding the safety lock and the base.

20. The apparatus of claim 19, wherein the safety lock is disposed between a shoulder of the housing and a shoulder of the base when the safety lock is in the first position.

21. The apparatus of claim 19, wherein the safety lock is configured to be moved from the first position to the second position by moving the safety lock in a direction normal to a longitudinal axis of the needle.

22. The apparatus of claim 21, wherein the longitudinal axis of the needle is noncoaxial to a longitudinal axis of the energy storage member.

23. The apparatus of claim 19, wherein the safety lock has a first end and a second end, the second end having an extended portion that includes a protrusion, the protrusion configured to engage a portion of the housing to couple the safety lock to the housing in the first position.

24. The apparatus of claim 23, wherein:

the extended portion is a first extended portion;

the protrusion is a first protrusion;

the portion of the housing is a first portion of the housing; and

the safety lock includes a second extended portion having a second protrusion, the second protrusion configured to engage a second portion of the housing to couple the safety lock in the first position.

25. The apparatus of claim 19, wherein the medicament container contains epinephrine.

26. The apparatus of claim 19, wherein:

the housing defines a status window, at least a portion of the medicament container visible through the status window when the medicament container is in the first container position, a centerline of the status window noncoaxial to a longitudinal centerline of the housing.