Devices, systems and methods for medicament delivery

• US 9,833,573 B2
• Filed: 05/09/2016
• Issued: 12/05/2017
• Est. Priority Date: 11/22/2004
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T.
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US15/149,425
• Publication Number:
  US 20160250414A1
• Time in Patent Office: 575 Days
• Field of Search: 604131, 604140, 604141, 604191
• 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 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/8218 Gas operated
• 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 5/31501 Means for blocking or restricting the movement of the rod or piston A61M5/5013 takes precedence
• 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

Abstract

An apparatus includes a housing, a medicament container, an actuator, and a biasing member. The actuator is configured to move the medicament container within the housing when the actuator is moved from a first configuration to a second configuration. The actuator includes a gas container and a puncturer. When the actuator is in the first configuration, a portion of the puncturer is disposed apart from the gas container. When the actuator is in the second configuration, the portion of the puncturer is disposed within the gas container. The gas container has a longitudinal axis offset from a longitudinal axis of the medicament container. The biasing member is configured to bias the actuator toward the second configuration.

Claims

1. A method, comprising:

moving an actuation lock of a medical injector from a first position to a second position, the medical injector including a housing, a base, an energy storage member, a needle, and a medicament container containing a dose of epinephrine;

placing a distal end surface of the base of the medical injector into contact with a thigh, the distal end surface of the base defining an opening; and

pressing the base against the thigh such that the base moves relative to the housing to cause the energy storage member within the housing to produce a force to move the needle from a first needle position to a second needle position, the needle being fluidically isolated from the medicament within the medicament container when the needle is in the first needle position, a distal tip of the needle extending through the opening of the base by a distance of between 5.13 millimeters and 9.98 millimeters when the needle is in the second needle position, a portion of the force exerted on a plunger within the medicament container to A) rupture a frangible seal to place the needle in fluid communication with the medicament after the needle is in the second needle position and B) expel the dose of epinephrine from the medicament container when the needle is in the second needle position, the medicament container being stationary within the housing when the base moves relative to the housing.

2. The method of claim 1, wherein the energy storage member is a gas container storing a compressed gas, the pressing the base actuates the gas container to release at least a portion of the compressed gas from the gas container.

3. The method of claim 1, wherein the moving the actuation lock includes moving the actuation lock in a direction nonparallel to a longitudinal axis of the needle.

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

5. The method of claim 1, further comprising:

viewing, before the placing, the dose of epinephrine via a status window of the housing to determine whether the epinephrine is discolored.

6. The method of claim 1, wherein in response to the actuating, a use indicator moves within the housing from a first indicator position before the dose of epinephrine is expelled to a second indicator position after the dose of epinephrine is expelled, the method further comprising:

viewing, after the actuating, the use indicator via a status window of the housing.

16. The method of claim 1, wherein the dose of epinephrine is delivered intramuscularly within the thigh.

17. The method of claim 1, wherein the distal end surface of the base has a non-circular shape.

18. The method of claim 17, wherein the distal end surface of the base has an aspect ratio of between 1.75 and 2.75.

19. The method of claim 1, wherein:

the portion of the force exerted on the plunger causes a proximal tip of the needle to puncture the frangible seal and move into the medicament container when the needle is moved to the second needle position.

25. The method of claim 1, wherein:

the medical injector includes an actuation member;

a protrusion of the actuation lock being disposed between opposing projections of the actuation member to prevent movement of the opposing projections toward each other when the actuation lock is in the first position; and

movement of the base causes the opposing projections to move toward each other thereby releasing the actuation member such that the energy storage member produces the force.

7. A method, comprising:

removing an actuation lock from a medical injector, the actuation lock preventing movement of a base of the medical injector when the actuation lock is coupled to the medical injector, the base movably coupled to a distal end portion of a housing of the medical injector;

placing an end surface of the base of the medical injector into contact with a target location of a body, the end surface of the base having a non-circular shape, a needle of the medical injector configured to move between a first needle position and a second needle position, the needle disposed within the housing when the needle is in the first needle position, the needle disposed through the base such that a distal tip of the needle extends a distance of between 5.13 millimeters and 9.98 millimeters when the needle is in the second needle position; and

actuating the medical injector by moving the base relative to the housing, thereby causing an energy storage member within the housing to produce a force to (A) move the needle from the first needle position to the second needle position and (B) expel a dose of epinephrine from the medical injector when the needle is in the second needle position, the needle being stationary relative to the housing when the base is moving relative to the housing.

8. The method of claim 7, wherein:

the housing includes a medicament container configured to contain the dose of epinephrine, the medicament container coupled to the needle; and

a portion of the force is exerted on a plunger within the medicament container to fluidically couple a proximal tip of the needle to the medicament container after the needle is in the second needle position.

9. The method of claim 7, wherein the energy storage member is a gas container storing a compressed gas, the actuating the medical injector causes the release of at least a portion of the compressed gas from the gas container.

10. The method of claim 7, wherein the removing the actuation lock includes removing the actuation lock in a direction nonparallel to a longitudinal axis of the needle.

11. The method of claim 10, wherein the direction is normal to the longitudinal axis of the needle.

12. The method of claim 11, wherein the longitudinal axis of the needle is noncoaxial to a longitudinal axis of the energy storage member.

20. The method of claim 7, wherein the distance is greater than 6 mm.

21. The method of claim 7, wherein:

the target location is a thigh; and

the actuating includes pressing the base against the thigh such that the base moves relative to the housing.

26. The method of claim 7, wherein the base has a width of between about 1.75 inches and 2.75 inches and a thickness of less than one inch.

27. The method of claim 7, wherein the target location and the distance being such that the dose of epinephrine is delivered intramuscularly to the body.

13. A method, comprising:

moving a safety lock of a medical injector from a first position to a second position, the safety lock coupled to an end portion of the housing and including a protrusion disposed between opposing projections of an actuation member of the medical injector to prevent movement of the opposing projections toward each other when the safety lock is in the first position, the safety lock spaced apart from the actuation member to allow movement of the opposing projections toward each other when the safety lock is in the second position;

placing an end surface of a base into contact with a target location of a body, the medical injector including a needle configured to move between a first needle position and a second needle position, the needle disposed within the housing of the medical injector when the needle is in the first needle position; and

pressing the end surface of the base against the target location to move the base relative to the housing, movement of the base causing the opposing projections to move toward each other thereby releasing the actuation member such that an energy storage member within the housing produces a force to move the actuation member within the housing, the needle moving, in response to movement of the actuation member, from the first needle position to the second needle position, a distal tip of the needle extending from the medical injector by a distance of between 5.13 millimeters and 9.98 millimeters when the needle is in the second needle position, a dose of medicament from the medical injector being expelled when the needle is in the second needle position.

14. The method of claim 13, wherein:

the medical injector includes a medicament container fluidically coupled to the needle when the needle is in the second needle position, the medicament container containing the dose of epinephrine; and

a plunger moves within a medicament container;

in response to movement of the actuation member, to expel the dose of epinephrine from the medicament container through the needle.

15. The method of claim 13, wherein the medical injector includes a gas container storing a compressed gas, movement of the actuation member causing release of at least a portion of the compressed gas from the gas container.

22. The method of claim 13, wherein the distance is greater than 6 mm.

23. The method of claim 13, wherein:

the target location is a thigh; and

the dose of epinephrine is delivered intramuscularly into the thigh.

24. The method of claim 23, wherein the end surface of the base has a non-circular shape.