Compact auto-injector

• US 10,449,296 B2
• Filed: 02/11/2019
• Issued: 10/22/2019
• Est. Priority Date: 08/30/2017
• Status: Active Grant

• Current Assignee: Pirouette Medical Incorporated
• Original Assignee: Pirouette Medical LLC
• Inventors: Kapas, Elijah, Kane, Matthew, Cullinane, Conor
• Primary Examiner(s): Shah, Nilay J
• Application Number:
  US16/272,628
• Publication Number:
  US 20190167905A1
• Time in Patent Office: 253 Days
• CPC Class Codes: A61M 2005/14284 with needle insertion means
• 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 2005/2474 with movable piercing means, e.g. ampoule remains fixed or steady
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• 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 5/24 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 5/2466 by piercing without internal pressure increase A61M5/2429 takes 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 5/31571 Means preventing accidental administration for automatic syringes A61M5/20
• CPC Class Codes: A61M 5/3158 performed by axially moving actuator operated by user, e.g. an injection button
• 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 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A novel single use auto-injector for delivering a fixed amount of medicament is described. The auto-injector may include a sealed housing rotatably held in a cover. Once the auto-injector is positioned at the injection location, the user can transition the housing from a locked to an armed position. The user can then compress the sealed housing into the cover, triggering activation mechanisms that initiate the injection. A first activation mechanism engages an interlock to prevent reuse of the auto-injector. A second activation mechanism straightens and extends a curved needle to a set the exposed needle length. A third activation mechanism pierces a sealed reservoir allowing the medicament to be forced through the injection needle. Following the injection, the auto-injector expands and interlocks, retracting the needle into the auto-injector and preventing reuse.

Claims

1. A compact, high aspect ratio auto-injector for delivering a medicament dose subcutaneously or intramuscularly, the auto-injector comprising:

a housing;

a medicament dispensing system disposed within the housing and comprising a medicament reservoir adapted to contain the dose; and

a needle extension mechanism coupled to the medicament reservoir, the needle extension mechanism comprising a curved injection needle and a needle guide adapted to straighten the curved injection needle during deployment of the curved injection needle through the needle guide, such that the curved injection needle is non-self-straightening and is straightened by the needle guide, to facilitate dispensing of the dose by the auto-injector.

2. The auto-injector according to claim 1, wherein the housing comprises a sealed housing rotatably retained in a cover.

3. The auto-injector according to claim 2, where the housing further comprises an interface to receive user input to facilitate a manual rotation of the housing relative to the cover from a first locked position to a second unlocked position.

4. The auto-injector according to claim 3, wherein at least one of the housing, the cover, a label, and a component directly visible to a user comprises indicia indicating the locked position, the unlocked position, and an armed position.

5. The auto-injector according to claim 3, wherein the auto-injector further comprises a biasing member, such that when the housing is rotated to the unlocked position, the sealed housing is automatically displaced axially relative to the cover, increasing a height of the auto-injector.

6. The auto-injector according to claim 5, wherein the biasing member comprises a spring that is at least one of integrally formed with the housing integrally formed with the cover, and disposed between the housing and the cover.

7. The auto-injector according to claim 5, wherein the auto-injector further comprises an interlock, such that the housing cannot be rotated relative to the cover or displaced axially relative to the cover without removal of the interlock.

8. The auto-injector according to claim 5, wherein manual compression of the auto-injector in an armed position, reduces the height of the auto-injector, and activates a mechanism that straightens and extends a distal end of the curved injection needle through the housing, dispenses the dose through the curved injection needle, and activates an interlock.

9. The auto-injector according to claim 8, wherein upon release of the manual compression, the biasing member automatically displaces the housing axially relatively to the cover, increasing the height of the auto-injector and retracting the distal end of the curved injection needle into the housing.

10. The auto-injector according to claim 9, wherein the auto-injector further comprises an interlock to prevent subsequent manual compression of the auto-injector, thereby rendering the auto-injector single-use.

11. The auto-injector according to claim 10, wherein the interlock comprises an abutting structure in the housing and the cover.

12. The auto-injector according to claim 1, wherein the medicament dispensing system further comprises a plunger within the medicament reservoir and forming a sealed cavity for retaining the dose.

13. The auto-injector according to claim 12, wherein the medicament dispensing system further comprises a dispensing needle in fluidic communication with the curved injection needle.

14. The auto-injector according to claim 13, further comprising a flexible tube interconnecting the dispensing needle with the curved injection needle.

15. The auto-injector according to claim 13, wherein the medicament dispensing system further comprises a spring, a retainer, and a locking mechanism such that when the locking mechanism is released, the spring displaces the retainer and forces the dispensing needle to pierce the plunger to provide fluidic communication with the dose.

16. The auto-injector according to claim 15, wherein the cover comprises a second trigger to release the retainer and the locking mechanism.

17. The auto-injector according to claim 15, wherein the spring further displaces the plunger to pump the dose out of the vial and through the dispensing needle to the curved injection needle.

18. The auto-injector according to claim 15, wherein the spring comprises a compression spring.

19. The auto-injector according to claim 1, wherein the needle extension mechanism further comprises a needle barrel for supporting the curved injection needle, a spring coupled to the barrel for rotating the barrel to uncoil the curved injection needle, and a barrel locking mechanism to prevent inadvertent rotation of the barrel.

20. The auto-injector according to claim 19, wherein the spring comprises a torsion spring.

21. The auto-injector according to claim 19, wherein a cover of the housing forms an aperture aligned with the needle guide through which a distal end of the curved injection needle passes during rotation of the barrel.

22. The auto-injector according to claim 21, wherein release of the barrel locking mechanism permits the spring to rotate the barrel and deploy the curved injection needle.

23. The auto-injector according to claim 22, wherein the cover comprises a first trigger to release the barrel locking mechanism.

24. The auto-injector according to claim 19, wherein the needle extension mechanism further comprises a needle barrel cap to secure a proximal end of the curved injection needle to the needle barrel.

25. A method of operating a compact, high aspect ratio auto-injector for delivering a medicament dose subcutaneously or intramuscularly, the autoinjector comprising a housing, a medicament dispensing system disposed in the housing and comprising a medicament reservoir adapted to contain the dose, and a needle extension mechanism coupled to the medicament reservoir, the needle extension mechanism comprising a curved injection needle and a needle guide, the method comprising the steps of:

triggering deployment of a distal end of the curved injection needle through an aperture in a cover of the housing aligned with the needle guide to straighten the curved injection needle, wherein the curved injection needle is non-self-straightening and is straightened by the needle guide;

triggering piercing of the medicament reservoir to provide fluidic communication between the medicament reservoir and the curved injection needle;

dispensing the dose through the curved injection needle at a desired injection location; and

thereafter, retracting the distal end of the curved injection needle into the auto-injector.

26. The method according to claim 25, wherein the auto-injector further comprises an interlock, such that the housing cannot be rotated relative to the cover or displaced axially relative to the cover without removal of the interlock.

27. The method according to claim 25, wherein the housing comprises a sealed housing rotatably retained in the cover, the method further comprising the steps of:

manually rotating the housing relative to the cover from a first locked position to a second unlocked position, in which the sealed housing is automatically displaced axially relative to the cover to an armed position, increasing a height of the auto-injector.

28. The method according to claim 27, further comprising the step of determining the locked position, the unlocked position, and the armed position based on indicia on at least one of the housing, the cover, a label, and a component directly visible to a user.

29. The method according to claim 27, further comprising the step of adhering the cover to the desired injection location prior to triggering of the auto-injector.

30. The method according to claim 25, wherein the step of triggering piercing of the medicament reservoir comprises manually compressing the auto-injector when the auto-injector is in the armed position, which comprises activating the medicament dispensing mechanism triggering piercing of a plunger within the medicament reservoir with a distal end of a dispensing needle.