Devices, systems and methods for medicament delivery

• US 9,056,170 B2
• Filed: 12/16/2013
• Issued: 06/16/2015
• Est. Priority Date: 11/22/2004
• Status: Expired due to Fees

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F.
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US14/107,711
• Publication Number:
  US 20140188048A1
• Time in Patent Office: 547 Days
• Field of Search: 604131-155, 604/218
• US Class Current: 1/1
• 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

An apparatus includes a housing, a needle, a first energy storage member and a second energy storage member. The needle is movably disposed within the housing and is configured to be to be placed in fluid communication with a medicament container. 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 first energy storage member is disposed within the housing, and is configured to produce a first force when actuated. The second energy storage member is disposed within the housing, and is configured to be actuated in response to the first force to produce a second force to move the needle from the first needle position to the second needle position.

Claims

1. An apparatus, comprising:

a medicament container;

a needle coupled to the medicament container;

an energy storage member configured to produce a force to move the medicament container to an injection position in which a portion of the needle is disposed outside of a distal end portion of a housing;

an actuation member configured to actuate the energy storage member when moved within the housing between a first position and a second position;

a needle sheath covering the needle;

a sheath retainer surrounding at least a portion of the needle sheath the sheath retainer configured to remove the needle sheath from the needle when the sheath retainer is moved distally relative to the housing; and

a distal cap covering at least a portion of the sheath retainer the distal cap configured to be decoupled from the housing.

2. The apparatus of claim 1, wherein the sheath retainer includes at least one engagement mechanism engaged with the needle sheath, the at least one engagement mechanism configured to exert a force against the needle sheath to remove the needle sheath from the needle.

3. The apparatus of claim 1, wherein the sheath retainer includes a plurality of tabs configured to exert a force against a shoulder of the needle sheath when the sheath retainer is moved distally relative to the housing.

4. The apparatus of claim 1, wherein the sheath retainer includes a protrusion extending outwardly from the sheath retainer and a plurality of tabs, the protrusion configured to receive a distal force, the plurality of tabs configured to exert at least a portion of the distal force against a shoulder of the needle sheath to remove the needle sheath from the needle.

5. The apparatus of claim 1, wherein the distal cap limits a distal movement of the sheath retainer when the distal cap is coupled to the housing.

6. An apparatus, comprising:

a housing;

a medicament container configured to move within the housing between a first position and a second position;

a needle coupled to the medicament container, the needle disposed within the housing when the medicament container is in the first position, a portion of the needle disposed outside of the housing when the medicament container is in the second position;

a needle sheath configured to cover the needle when the medicament container is in the first position;

a sheath retainer including at least one engagement mechanism configured to exert a force against a shoulder of the needle sheath when the sheath retainer is moved distally relative to the housing to remove the needle sheath from the needle; and

a distal cap covering at least a portion of the sheath retainer, the distal cap configured to be decoupled from the housing.

7. The apparatus of claim 6, wherein the portion of the needle includes a distal end tip, the needle sheath configured to cover the distal end tip of needle.

8. The apparatus of claim 6, wherein:

the housing defines an opening through which the portion of the needle is disposed when the medicament container is in the second position; and

the sheath retainer is configured to cover the opening when the sheath retainer surrounds the portion of the needle sheath and the medicament container is in the first position.

9. The apparatus of claim 6, wherein:

the housing defines an opening through which the portion of the needle is disposed when the medicament container is in the second position; and

the distal cap is configured to cover the opening when the medicament container is in the first position and the distal cap is coupled to the medicament container.

10. The apparatus of claim 6, wherein the needle is substantially linear.

11. The apparatus of claim 6, wherein the needle sheath includes at least a rigid portion.

12. The apparatus of claim 6, wherein the medicament container is configured to move within the housing in a same direction as a movement of the sheath retainer.

13. The apparatus of claim 6, wherein the needle sheath is configured to maintain sterility of the needle when covering the needle.

14. The apparatus of claim 6, wherein the engagement portion of the sheath retainer includes a plurality of tabs configured to exert the force against the shoulder of the needle sheath when the sheath retainer is moved distally relative to the housing.

15. An apparatus, comprising:

a housing;

a medicament container configured to move within the housing between a first position and a second position in response to a first force produced by an energy storage member;

a needle coupled to the medicament container, the needle disposed within the housing when the medicament container is in the first position, a portion of the needle disposed outside of the housing when the medicament container is in the second position;

a needle sheath covering the needle; and

a sheath retainer configured to be disposed about at least a portion of the needle sheath, a distal end portion of the sheath retainer including a gripping protrusion configured to receive a second force to move the sheath retainer distally relative to the housing, the sheath retainer including an engagement mechanism configured to exert at least a portion of the second force against the needle sheath when the sheath retainer is moved distally, the sheath retainer including a locking protrusion configured to be disposed within a recess defined by the housing, the locking protrusion configured to resist distal movement of the sheath retainer when disposed within the recess.

16. The apparatus of claim 15, wherein the housing is an inner housing, the apparatus further comprising:

an outer housing, at least a portion of the inner housing configured to be removably disposed within the outer housing, the outer housing configured to surround at least a portion of the sheath retainer.

17. The apparatus of claim 15, wherein the needle sheath covering the needle is configured to maintain the sterility of the needle.

18. The apparatus of claim 15, wherein:

the housing defines an opening through which the portion of the needle is disposed when the medicament container is in the second position; and

the sheath retainer is configured to cover the opening when the sheath retainer is disposed about the portion of the needle sheath and the medicament container is in the first position; and

19. The apparatus of claim 15, wherein the medicament container contains epinephrine.

20. The apparatus of claim 15, wherein;

the sheath retainer includes a surface configured to engage a portion of the housing to limit proximal movement of the sheath retainer relative to the housing; and

the engagement mechanism of the sheath retainer includes retaining tab configured to engage the needle sheath to exert the portion of the second force against the needle sheath.