DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY

• US 20190009027A1
• Filed: 08/31/2018
• Published: 01/10/2019
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: EDWARDS, Evan Thomas, EDWARDS, Eric Shawn, LICATA, Mark J.
• Granted Patent: US 10,918,791 B2
• Time in Patent Office: Days
• 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 including a flexible member and a distal member, the flexible member configured to transition between a collapsed configuration and an 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 member of the expandable assembly within the medicament container to convey a medicament from the medicament container via the needle, the flexible member of the expandable assembly configured to actuate a valve to release the pressurized gas from the gas chamber when the flexible member is transitioned from the collapsed configuration to the expanded configuration.

2. The apparatus of claim 1, wherein the flexible member has a first size when in the collapsed configuration and a second size when in the expanded configuration, the flexible member 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 flexible-member actuates the valve after the medicament is conveyed from the medicament container.

3. The apparatus of claim 1, wherein:

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

4. The apparatus of claim 3, wherein:

the flexible member transfers a tensile force from the distal portion to the valve to actuate the valve when the distal portion has moved the predetermined distance.

5. The apparatus of claim 1, wherein the flexible member is one of a string, an elastic member or a biasing member.

6. 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 pusher configured to push the medicament from the medicament container and through the needle to convey the medicament out of the medicament container;

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

a flexible release member having a proximal portion and a distal portion, the flexible release member configured to transition between a collapsed configuration and an 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 pusher within the medicament container to convey a medicament from the medicament container via the needle, the flexible release member configured to actuate a valve to release the pressurized gas from the gas chamber when the flexible release member is transitioned from the collapsed configuration to the expanded configuration.

7. The apparatus of claim 6, wherein the flexible release member has a first size when in the collapsed configuration and a second size when in the expanded configuration, the flexible release member being transitioned from the collapsed configuration to the expanded configuration when the distal portion of the expandable assembly moves within the medicament container such that the flexible release member actuates the valve after the medicament is conveyed from the medicament container.

8. The apparatus of claim 6, wherein:

a length of the flexible release member increases when the pusher moves within the medicament container to convey the medicament; and

the proximal portion of the flexible member is configured to actuate the valve when the distal portion of the flexible member moves a predetermined distance within the medicament container.

9. The apparatus of claim 6, wherein:

the flexible release member is a tension member; and

the tension member transfers a tensile force from the distal portion to the valve via the proximal portion to actuate the valve when the distal portion has moved the predetermined distance.

10. The apparatus of claim 6, wherein:

a length of the flexible release member increases when the pusher 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 flexible release member decreases when the needle moves from the second position towards the first needle position.

11. A method of delivering a medicament from a medical injector, comprising:

placing a distal end surface of a base of the medical injector into contact with a body, the medical injector including a housing, a medicament container within the housing, a plunger within the medicament container, a needle fluidically coupled to the medicament container, an energy storage member, a valve, and a flexible member coupled between the plunger and the valve; and

actuating the medical injector to cause the energy storage member to produce a pressurized gas within a gas chamber defined by the housing, the pressurized gas exerting a force to;

A) move the needle from a first needle position, in which the needle is within the housing, to a second needle position, in which a portion of the needle is outside of the housing and B) move the plunger within the medicament container to convey the medicament from the medicament container via the needle,

the flexible member transitioning from a first configuration to a second configuration when the plunger moves within the medicament container, the flexible member actuating the valve to release the pressurized gas from the gas chamber when the flexible member is transitioned from the first configuration to the second configuration.

12. The method of claim 11, wherein:

the medical injector includes a retraction spring within the housing, the retraction spring causing the needle to move towards the first needle position after the pressurized gas is released from the gas chamber.

13. The method of claim 11, wherein the actuating includes pressing the base against a target surface of the body to move the base relative to the housing.

14. The method of claim 13, further comprising:

removing, before the placing, an actuator guard from an end portion of the housing, the actuator guard configured to limit movement of the base when the actuator guard is coupled to the housing.

15. The method of claim 11, wherein a length of the flexible member increases when the flexible member transitions from the first configuration to the second configuration.

16. The method of claim 15, wherein:

a proximal end portion of the flexible member is coupled to the valve; and

the length of the expandable assembly increases when the plunger moves within the medicament container, the proximal end portion of the flexible member actuating the valve when the plunger moves a predetermined distance within the medicament container.

17. The method of claim 16, wherein the flexible member is one of a string, an elastic member or a biasing member.

18. The method of claim 17, wherein:

a portion of the valve is within a vent opening defined by the housing to fluidically isolate the gas chamber from an external volume when the valve is in a first valve position, the proximal end portion of the flexible member moving the valve to a second valve position when the flexible member is transitioned to its second configuration, the gas chamber in fluid communication with the external volume via the vent opening when the valve is in the second valve position.

19. The method of claim 11, wherein the medicament is any one of a drug or a biologic product.

20. The method of claim 11, wherein the medicament is a biologic product containing at least one of a hormone or an antidote.

21. The method of claim 11, wherein the medicament is epinephrine.

22. A method of delivering a medicament from a medical injector, comprising:

moving an actuator of a medical injector relative to a housing of the medical injector, the medical injector including a housing, a medicament container within the housing, a plunger within the medicament container, a needle fluidically coupled to the medicament container, an energy storage member, a valve, and a flexible member coupled between the plunger and the valve;

producing, from the energy storage member in response to the moving the actuator, a pressurized gas within a gas chamber defined by the housing;

moving, in response to the pressurized gas, the needle from a first needle position, in which the needle is within the housing, to a second needle position, in which a portion of the needle is outside of the housing;

moving, in response to the pressurized gas, the plunger within the medicament container to convey the medicament from the medicament container via the needle;

transitioning the flexible member from a first configuration to a second configuration when the plunger moves within the medicament container;

actuating the valve to release the pressurized gas from the gas chamber when the flexible member is transitioned from the first configuration to the second configuration; and

23. The method of claim 22, wherein the medical injector includes a retraction spring, the method further comprising:

moving the needle towards the first needle position after the pressurized gas is released from the gas chamber.

24. The method of claim 22, wherein the transitioning the flexible member includes increasing a length of the flexible member.

25. The method of claim 24, wherein the flexible member is one of a string, an elastic member or a biasing member.

26. The method of claim 25, wherein:

a portion of the valve is within a vent opening defined by the housing to fluidically isolate the gas chamber from an external volume;

the actuating the valve includes moving the portion of the valve out of the vent opening to place the gas chamber in fluid communication with the external volume.

27. The method of claim 26, wherein the medical injector includes a cover disposed about the opening, the cover configured to limit access to the opening from the external volume.

28. The method of claim 25, wherein:

a proximal end portion of the flexible member is coupled to the valve; and

the length of the expandable assembly increases when the plunger moves within the medicament container, the proximal end portion of the flexible member actuating the valve when the plunger moves a predetermined distance within the medicament container.

29. A method, comprising:

placing an outer housing of a medical injector into contact with a body, the outer housing enclosing an inner housing, a medicament pusher, and a gas container storing a compressed gas, the medicament pusher at least partially disposed within the inner housing and in contact with a flexible release member disposed therein, the flexible release member being in a first configuration associated with a pre-activation status prior to placing the outer housing into contact with the body;

injecting a medicament contained within the inner housing into the body, the injecting including releasing at least a portion of the compressed gas from the gas container into a gas chamber defined at least in part by the outer housing, the force associated with the compressed gas released into the gas chamber being sufficient to move at least the pusher in a distal direction toward the body to inject the medicament into the body, the flexible release member configured to move from the first configuration toward a second configuration along with the medicament pusher moving in the distal direction; and

expelling at least a portion of the compressed gas released into the gas chamber out of the outer housing through a release mechanism, the expelling including the flexible release member engaging the release mechanism when in the second configuration after movement of the medicament pusher.

30. The method of claim 29, wherein:

the releasing at least a portion of the compressed gas from the gas container moves the medicament pusher from a first position to a second position to expel the medicament from the medicament container.

31. The method of claim 29, wherein:

the placing the outer housing includes placing a contact member movably coupled to a distal end portion of the outer housing in contact with a target surface of the body; and

the flexible release member configured to move from the first configuration to the second configuration when the contact member is stationary relative to the outer housing.

32. The method of claim 29, wherein the outer housing is the outer housing of an auto-injector, the inner housing is a medicament container containing the medicament, the method further comprising:

removing, before the placing, an actuator guard from an end portion of the outer housing, the actuator guard configured to limit movement of an actuator when the actuator guard is coupled to the outer housing, the actuator configured to release the compressed gas from the gas container into the gas chamber.

33. The method of claim 32, wherein:

the auto-injector further includes a needle coupled to the medicament pusher;

an end portion of the needle being moved from a first needle position within the outer housing to a second needle position outside of the outer housing in response to movement of the medicament pusher; and

the injecting the medicament includes injecting the medicament into the body via the needle when the needle is in the second needle position outside of the outer housing.