Devices, systems and methods for medicament delivery

• US 10,335,549 B2
• Filed: 06/23/2017
• Issued: 07/02/2019
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US15/631,076
• Publication Number:
  US 20170290982A1
• Time in Patent Office: 739 Days
• 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

A method includes moving an actuation lock of a medical injector from a first position to a second position. The actuation lock has an extended portion disposed between a shoulder of a housing and the base when the actuation lock is in the first position. The extended portion is spaced apart from the base when the actuation lock is in the second position. A distal end portion of a base, which is movably coupled to an end portion of the housing, is placed into contact with a body. The base is actuated after the placing to release an energy from an energy storage member within the housing to produce a force to move a needle from a first needle position to a second needle position. At least a portion of the needle extends through the base when the needle is in the second needle position.

Claims

1. An apparatus, comprising:

a housing;

a medicament container disposed within the housing

a plunger having distal end configured to move within the medicament container between a first position and a second position in repsonse to a first force;

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

a needle sheath covering the needle; and

a sheath retainer removably coupled to the housing such a portion of the sheath retainer is disposed within the housing, the sheath retainer configured to be disposed about at least a portion of the needle sheath, the sheath retainer including a grip surface including a grip protrusion configured to receive a second force to move the sheath retainer in a distal direction relative to the housing, the sheath retainer including a retaining tab that engages the needle sheath and is configured to exert at least a portion of the second force against the needle sheath when the sheath retainer is moved in the distal direction, the portion of the second force removing the needle sheath from about the needle when the sheath retainer is removed from the housing in the distal direction, the sheath retainer including a lock protrusion configured to engage the housing to resist movement of the sheath retainer in the distal direction, an outer surface of the sheath retainer including an indicium indicating an order of operation for removal of the sheath retainer.

2. The apparatus of claim 1, wherein the needle sheath covering the needle is configured to maintain sterility of the needle.

3. The apparatus of claim 1, wherein the medicament container contains epinephrine.

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

a spring configured to urge the medicament container in a proximal direction.

5. The apparatus of claim 1, wherein:

the housing defines a status window; and

a content of the medicament container are viewable through the status window when the distal end of the plunger is in the first position.

6. The apparatus of claim 1, further comprising:

a pressurized gas container configured to produce the first force in response to the movement of an actuator; and

the pressurized gas container being operably coupled to the plunger such that the first force is exerted on the plunger to cause the distal end to move from the first position to the second position.

7. An apparatus comprising:

a housing;

a medicament container disposed within the housing;

a plunger having a first plunger end portion, the first plunger end portion configured to move distally in response to a first force;

a needle coupled to the medicament container, a portion of the needle disposed outside of the housing;

a needle sheath covering the needle;

a sheath retainer having a portion disposed about the needle sheath, the sheath retainer including a retaining tab that engages the needle sheath and is configured to exert a removal force against the needle sheath when the sheath retainer is moved in a distal direction relative to the housing to remove the needle sheath from the needle; and

a cover configured to limit movement of the sheath retainer in the distal direction when the cover is coupled about the housing, the cover configured to be coupled to and decoupled from the housing.

8. The apparatus of claim 7, wherein the medicament container contains epinephrine.

9. The apparatus of claim 7, wherein the medicament container is configured to move within the housing, the apparatus further comprising:

a spring configured to urge the medicament container in a proximal direction.

10. The apparatus of claim 7, wherein the sheath retainer includes a grip surface configured to receive the removal force to move the sheath retainer in the distal direction relative to the housing, and the sheath retainer includes a lock protrusion configured to engage the housing to resist movement of the sheath retainer in the distal direction.

11. The apparatus of claim 7, wherein the sheath retainer includes a grip surface configured to receive the removal force to move the sheath retainer in the distal direction relative to the housing.

12. The apparatus of claim 7, wherein the retaining tab is one of a plurality of retaining tabs that engage a distal end portion of the needle sheath.

13. The apparatus of claim 7, wherein the sheath retainer includes a lock protrusion to removably couple the sheath retainer to a base portion, the base portion being secured to an end portion of the housing.

14. The apparatus of claim 7, wherein the sheath retainer includes an indicum with a numeral to indicate an order of operation and an arrow to indicated the distal direction in which the sheath retainer should be moved.

15. The apparatus of claim 7, further comprising an elastomeric member disposed within the medicament container.

16. The apparatus of claim 15, further comprising an actuator coupled to the housing, the actuator configured to move from a first actuator position to a second actuator position to produce the first force to move the elastomeric member within the medicament container to expel a medicament from within the medicament container via the needle.

17. The apparatus of claim 16, further comprising:

a pressurized gas container configured to produce the first force in response to the actuator being moved; and

the pressurized gas container being operably coupled to the plunger such that the first force is exerted on the plunger to cause the clastomeric member to move distally from a first position to a second position.

18. The apparatus of claim 16, wherein:

the housing defines a status window; and

a contents of the medicament container are viewable through the status window when the actuator is in the first actuator position.

19. The apparatus of claim 18, further comprising:

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

20. An apparatus comprising:

a housing;

a medicament container disposed within the housing;

a plunger having a first plunger end portion, the first plunger end portion configured to move distally within the medicament container in response to a first force;

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

a needle sheath covering the needle; and

a sheath retainer having a portion disposed about the needle sheath, the sheath retainer including a retaining tab that engages the needle sheath and is configured to exert a removal force against the needle sheath when the sheath retainer is moved distally relative to the housing to remove the needle sheath from the needle, the sheath retainer including an indicium with a numeral to indicate an order of operation and an arrow to indicate a direction in which the sheath retainer should be moved.

21. The apparatus of claim 20, wherein the medicament container contains epinephrine.

22. The apparatus of claim 20, wherein the retaining tab is one of a plurality of retaining tabs that engage a distal end portion of the needle sheath.

23. The apparatus of claim 20, wherein the medicament container includes an elastomeric member within the medicament container, the apparatus further comprising:

an actuator coupled to the housing, the actuator configured to move from a first actuator position to a second actuator position to produce the first force to move the elastomeric member within the medicament container to expel a medicament from within the medicament container via the needle.

24. The apparatus of claim 23, wherein:

the housing defines a status window; and

the medicament within the medicament container is viewable through the status window when the actuator is in the first actuator position.

25. The apparatus of claim 20, wherein the medicament container is configured to move within the housing, the apparatus further comprising:

a spring configured to urge the medicament container in a proximal direction.

26. An apparatus comprising:

a housing;

a medicament container disposed within the housing, the medicament container configured to move within the housing;

a spring within the housing, the spring configured to urge the medicament container in a proximal direction;

a plunger having an end portion configured to move in a distal direction within the medicament container in response to an injection force;

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

a needle sheath covering the needle; and

a sheath retainer having a portion disposed about the needle sheath, the sheath retainer including a retaining tab that engages the needle sheath and is configured to exert a removal force against the needle sheath when the sheath retainer is moved in the distal direction relative to the housing to remove the needle sheath from the needle.

27. The apparatus of claim 26, wherein the medicament container contains epinephrine.

28. The apparatus of claim 26, wherein the retaining tab is one of a plurality of retaining tabs that engage a distal end portion of the needle sheath.

29. The apparatus of claim 26, wherein the medicament container includes an elastomeric member within the medicament container, the apparatus further comprising:

an actuator coupled to the housing, the actuator configured to move from a first actuator position to a second actuator position to produce the injection force to move the elastomeric member within the medicament container to expel a medicament from within the medicament container via the needle.

30. The apparatus of claim 29, wherein:

the housing defines a status window; and

the medicament within the medicament container is viewable through the status window when the actuator is in the first actuator position.

31. The apparatus of claim 30, further comprising:

a cover configured to limit movement of the sheath retainer in the distal direction when the cover is coupled about the housing, the cover configured to be coupled to and decoupled from the housing.