DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY

• US 20160022909A1
• Filed: 10/05/2015
• Published: 01/28/2016
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: EDWARDS, Evan Thomas, Edwards, Eric Shawn, Licata, Mark J.
• Granted Patent: US 10,071,203 B2
• Time in Patent Office: Days
• 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 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• 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 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2039/1083 having a plurality of female connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2039/1088 having a plurality of male connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• 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 2205/18 with alarm
• 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 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 5/2066 : comprising means for injection of two or more media, e.g. by mixing
• 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 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• 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: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/20 : for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

An apparatus includes a movable member and a valve coupled to the movable member. The movable member is configured to be disposed within a housing of a medical device and has a first end portion and second end portion. A portion of the first end portion is configured to define a portion of a boundary of a gas chamber. The first end portion defines an opening configured to be in fluid communication between the gas chamber and an area outside the gas chamber. The second end portion is configured to be coupled to a needle configured to deliver a medicament into a body. The valve is configured to selectively allow fluid communication between the gas chamber and the area outside the gas chamber through the opening defined by the first end portion of the movable member.

Claims

1. An apparatus, comprising:

a housing defining a gas chamber;

a medicament container disposed within the housing;

a needle fluidically coupled to the medicament container, the needle configured to move between a first needle position, in which the needle is disposed within the housing, and a second needle position in which a portion of the needle extends from the housing;

a retraction spring configured to bias the needle towards the first needle position;

an expandable assembly configured to transition between a collapsed configuration and an expanded configuration, the expandable assembly including a proximal member and a distal member; and

an energy storage member configured to produce a pressurized gas within the gas chamber, the pressurized gas exerting a force to move the needle from the first needle position to the second needle position and to move the distal member of the expandable assembly within the medicament container to convey a medicament from the medicament container via the needle, the proximal member of the expandable assembly configured to actuate a valve to release the pressurized gas from the gas chamber when the expandable assembly is transitioned from the collapsed configuration to the expanded configuration.

2. The apparatus of claim 1, wherein the retraction spring causes the needle to move towards the first needle position after the pressurized gas is released from the gas chamber.

3. The apparatus of claim 1, wherein the expandable assembly has a first size when in the collapsed configuration and a second size when in the expanded configuration, the expandable assembly being transitioned from the collapsed configuration to the expanded configuration when the distal member of the expandable assembly moves within the medicament container such that the proximal member actuates the valve after the medicament is conveyed from the medicament container.

4. The apparatus of claim 1, wherein a length of the expandable assembly increases when the distal member of the expandable assembly moves within the medicament container to convey the medicament.

5. The apparatus of claim 1, wherein:

the proximal member of the expandable assembly is coupled to the valve; and

a length of the expandable assembly increases when the distal member of the expandable assembly moves within the medicament container to convey the medicament, the proximal member actuating the valve when the distal member moves a predetermined distance within the medicament container.

6. The apparatus of claim 1, wherein:

a length of the expandable assembly increases when the distal member of the expandable assembly moves within the medicament container to convey the medicament;

the retraction spring causes the needle to move from the second needle position towards the first needle position after the pressurized gas is released from the gas chamber; and

the length of the expandable assembly decreases when the needle moves from the second position towards the first needle position.

7. The apparatus of claim 1, further comprising:

the valve, the valve being any one of a rigid member, a flexible member, or a frangible seal about an opening.

8. The apparatus of claim 1, wherein the medicament container contains the medicament, the medicament being any one of a drug or a biologic product.

9. The apparatus of claim 1, wherein the medicament container contains the medicament, the medicament being a biologic product containing at least one of a hormone or an antidote.

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

11. An apparatus, comprising:

a housing defining a gas chamber;

a medicament container disposed within the housing;

a needle fluidically coupled to the medicament container, the needle configured to move between a first needle position, in which the needle is disposed within the housing, and a second needle position in which a portion of the needle extends from the housing;

a valve configured to move relative to the housing between a first valve position and a second valve position, the valve configured to fluidically isolate the gas chamber from an external volume when the valve is in the first valve position, the gas chamber in fluid communication with the external volume when the valve is in the second valve position;

an expandable assembly disposed within the housing, a proximal end portion of the expandable assembly coupled to the valve, a distal end portion of the expandable assembly disposed within the medicament container, the expandable assembly configured to move the valve from the first valve position to the second valve position when the expandable assembly is transitioned from the collapsed configuration to the expanded configuration; and

an energy storage member configured to produce a pressurized gas within the gas chamber, the pressurized gas exerting a force to move the needle from the first needle position to the second needle position and to move the distal end portion of the expandable assembly within the medicament container to convey a medicament from the medicament container via the needle.

12. The apparatus of claim 11, wherein the expandable assembly has a first length when in the collapsed configuration and a second length when in the expanded configuration, the second length greater than the first length.

13. The apparatus of claim 11, wherein a length of the expandable assembly increases when the distal end portion of the expandable assembly moves within the medicament container to convey the medicament.

14. The apparatus of claim 11, wherein the expandable assembly is transitioned from the collapsed configuration to the expanded configuration when the distal end portion of the expandable assembly moves within the medicament container such that the valve is moved to the second valve position after the medicament is conveyed from the medicament container.

15. The apparatus of claim 14, further comprising:

a retraction spring configured to move the needle from the second needle position towards the first needle position after the valve is moved to the second valve position.

16. The apparatus of claim 15, wherein the expandable assembly is configured to maintain the valve in the second valve position when the needle moves from the second needle position towards the first needle position.

18. The apparatus of claim 11, wherein a portion of the valve is press fit within an opening defined by the housing to fluidically isolate the gas chamber from the external volume when the valve is in the first valve position, the gas chamber in fluid communication with the external volume via the opening when the valve is in the second valve position.

17. The apparatus of 11, wherein the expandable assembly includes a flexible member.

19. An apparatus, comprising:

a housing defining a gas chamber;

a medicament container disposed within the housing;

a needle coupled to the medicament container, the needle configured to move between a first needle position, in which the needle is disposed within the housing, and a second needle position in which a portion of the needle extends from the housing;

a valve configured to transition between a first valve configuration and a second valve configuration when actuated, the valve including seal surface that engages a portion of the housing to fluidically isolate the gas chamber from an external volume when the valve is in the first valve configuration, the seal surface disengaged from the portion of the housing when the valve is in the second valve configuration;

an expandable assembly disposed within the housing, a first member of the expandable assembly coupled to the valve, a second member of the expandable assembly disposed within the medicament container, the expandable assembly having a first length when the second member is at a first position within the medicament container, the expandable assembly having a second length when the second member is at a second position within the medicament container, the first member configured to actuate the valve when the expandable assembly is transitioned from its first length to its second length; and

an energy storage member configured to produce a pressurized gas within the gas chamber, the pressurized gas exerting a force to move the second member of the expandable assembly within the medicament container to convey a medicament from the medicament container via the needle when the needle is in the second needle position.

20. The apparatus of claim 19, wherein the seal surface of the valve is press fit within an opening defined by the housing to fluidically isolate the gas chamber from the external volume when the valve is in the first valve configuration.

21. The apparatus of claim 20, wherein the seal surface of the valve defines at least a portion of a flow path through which the pressurized gas flows when the valve is in the second valve configuration.

22. The apparatus of claim 19, further comprising:

a retraction spring configured to move the needle from the second needle position towards the first needle position after the valve is moved to the second valve configuration.

23. The apparatus of claim 19, wherein:

the expandable assembly transitions from its second length towards its first length when the needle moves from the second position towards the first needle position, the expandable assembly is configured to maintain the valve in the second valve configuration when the expandable assembly transitions from its second length towards its first length.