Wearable automatic injection device for controlled delivery of therapeutic agents

• US 9,821,117 B2
• Filed: 10/01/2015
• Issued: 11/21/2017
• Est. Priority Date: 04/21/2010
• Status: Active Grant

• Current Assignee: AbbVie Biotechnology Ltd. (Puerto Rico) (Abbvie Incorporated)
• Original Assignee: AbbVie Biotechnology Ltd. (Puerto Rico) (Abbvie Incorporated)
• Inventors: Anderson, Philip D., Julian, Joseph F., Laurusonis, Linas P., Parmer, Timothy, Yoch, Travis, Jang, Samuel M., Corrigan, Sean, Matusaitis, Tomas, Fienup, William, Strahm, Chris
• Primary Examiner(s): GRAY, PHILLIP A
• Application Number:
  US14/872,949
• Publication Number:
  US 20160082189A1
• Time in Patent Office: 782 Days
• Field of Search: 604500-506, 604131, 604151-155, 604134-139, 6048901-8921
• CPC Class Codes: A61M 2005/004 Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• 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 2005/3143 Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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 5/326 : 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 5/484 : Regulating injection pressure
• CPC Class Codes: A61M 5/488 : Limiting injection pressure
• CPC Class Codes: A61M 5/50 : having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

Exemplary embodiments provide wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient'"'"'s body at controlled rates, for example, in a single bolus. Exemplary embodiments provide methods for assembling wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient'"'"'s body at controlled rates. Exemplary embodiments provide methods for using wearable automatic injection devices for subcutaneously injecting a therapeutic agent into a patient'"'"'s body at controlled rates.

Claims

1. A wearable automatic injection device for providing a subcutaneous injection of a therapeutic agent into a patient, the wearable automatic injection device comprising:

a housing comprising a patient contact portion securable to the patient;

an injection assembly moveably disposed in the housing having an injection needle for insertion into the patient;

a vessel provided in the housing for holding the therapeutic agent;

a syringe needle fluidically couplable to the vessel and the injection assembly;

a plunger moveably disposed in the vessel for ejecting the therapeutic agent from the vessel into the injection assembly;

a plunger actuation mechanism for actuating the plunger using a mechanical or hydraulic mechanism within the vessel; and

a transfer mechanism defining a sterile fluid conduit between the syringe needle and the injection needle.

2. The wearable automatic injection device of claim 1, further comprising:

an inspection window disposed in the housing that allows the user to inspect the therapeutic agent held by the vessel from outside the housing.

3. The wearable automatic injection device of claim 1, further comprising:

a pierceable septum separating the syringe needle from the sterile conduit in a pre-injection state.

4. The wearable automatic injection device of claim 3, wherein the syringe needle is spaced from the pierceable septum when the device is in the pre-injection state, and wherein the syringe needle pierces the septum when the device is in an injection state.

5. The wearable automatic injection device of claim 3, wherein the vessel moves towards the transfer mechanism in an injection state causing the syringe needle to pierce the septum and establishing fluid communication between the syringe needle and the injection needle.

6. The wearable automatic injection device of claim 1, wherein the vessel is moveably disposed within the housing.

7. The wearable automatic injection device of claim 6, further comprising:

a vessel actuator for automatically actuating the vessel from a first position in the pre-injection state to a second position in an injection state.

8. The wearable automatic injection device of claim 1, wherein the transfer mechanism comprises an adapter coupled to the syringe needle and the injection needle establishing the sterile fluid conduit between the syringe needle and the injection needle.

9. The wearable automatic injection device of claim 8, wherein a first portion of the adapter extends from the vessel substantially parallel to a longitudinal axis.

10. The wearable automatic injection device of claim 9, wherein a second portion of the adapter extends from the first portion of the adapter substantially perpendicular to the longitudinal axis.

11. The wearable automatic injection device of claim 10, wherein the second portion of the adapter couplable to the injection needle.

12. The wearable automatic injection device of claim 10, wherein the first portion of the adapter and the second portion of the adapter are formed integrally.

13. The wearable automatic injection device of claim 8, wherein the first portion of the adapter substantially envelopes a distal end of the vessel.

14. The wearable automatic injection device of claim 8, wherein the adapter enables the injection needle to extend at approximately 90 degrees relative to the longitudinal axis.

15. The wearable automatic injection device of claim 1, wherein the sterile fluid conduit is a centrally extending channel in the transfer mechanism through which the therapeutic agent flows from the syringe needle to the injection needle.

16. The wearable automatic injection device of claim 15, wherein the fluid conduit comprises raised wall portions extending along the edges of the centrally extending channel to constrain the therapeutic agent to the channel.

17. The wearable automatic injection device of claim 1, further comprising:

an injection button including the transfer mechanism.

18. The wearable automatic injection device of claim 1, wherein the plunger actuation mechanism and the patient contact portion are non-sterile.

19. The wearable automatic injection device of claim 1, wherein the housing is non-sterile.

20. The wearable automatic injection device of claim 1, wherein the plunger actuation mechanism includes a flow restrictor to regulate a rate of delivery of the therapeutic agent into the patient.

21. The wearable automatic injection device of claim 1, wherein the plunger actuation mechanism comprises a biasing mechanism.

22. The wearable automatic injection device of claim 21, wherein the plunger actuation mechanism further comprises:

a fusee; and

a tether coupling the biasing mechanism to the fusee and the plunger.

23. The wearable automatic injection device of claim 22, wherein the plunger actuation mechanism further comprises:

a damping mechanism coupled to the fusee for regulating the movement of the fusee; and

a gear train including one or more gears for coupling the fusee to the damping mechanism.

24. The wearable automatic injection device of claim 23, wherein the damping mechanism comprises a viscous damper.

25. The wearable automatic injection device of claim 23, wherein the damping mechanism comprises an escapement mechanism.

26. The wearable automatic injection device of claim 25, wherein the escapement mechanism is a swiss lever escapement.

27. The wearable automatic injection device of claim 25, wherein the escapement mechanism is a runaway escapement.

28. The wearable automatic injection device of claim 21, wherein the plunger actuation mechanism further comprises:

one or more ball bearings for coupling the biasing mechanism to the plunger.

29. The wearable automatic injection device of claim 28, wherein the plunger actuation mechanism further comprises:

a damping mechanism coupled to the biasing mechanism and the ball bearings for regulating the movement of the ball bearings.

30. The wearable automatic injection device of claim 29, wherein the damping mechanism comprises a viscous damper.

31. The wearable automatic injection device of claim 1, wherein the plunger actuation mechanism further comprises:

a source of a working fluid for providing a hydraulic pressure to eject the therapeutic agent from the vessel; and

a fluid conduit provided between the source of the working fluid and the plunger.

32. The wearable automatic injection device of claim 31, wherein the plunger actuation mechanism further comprises:

a damping mechanism coupled to the vessel and the source of the working fluid to regulate the ejection of the therapeutic agent from the vessel.

33. The wearable automatic injection device of claim 32, wherein the damping mechanism comprises a flow restrictor for maintaining the hydraulic pressure downstream of the flow restrictor toward the vessel at a lower pressure that the hydraulic pressure upstream of the flow restrictor toward the source of the working fluid.

34. The wearable automatic injection device of claim 1, further comprising:

a needle locking mechanism for automatically locking the injection needle in a retracted position within the housing in a post-injection state.

35. The wearable automatic injection device of claim 34, wherein the needle locking mechanism comprises:

a barrier mechanism moveably disposed over an injection needle aperture in the housing;

wherein the injection needle aperture is open and allows the injection needle to protrude outside the housing when the barrier mechanism is in a first position; and

wherein the injection needle aperture is closed and prevents the injection needle from protruding outside the housing when the barrier mechanism is in a second position.

36. The wearable automatic injection device of claim 34, wherein the needle locking mechanism comprises:

a needle lock release mechanism responsive to retraction of the injection assembly from an extended position in the injection state to a retracted position in the post-injection state; and

a pivoting member coupled to the injection needle and to the needle lock release mechanism;

wherein activation of the needle lock release mechanism causes the pivoting member to pivot the injection needle away from an injection needle aperture in the housing.

37. The wearable automatic injection device of claim 1, wherein the therapeutic agent comprises a protein in a solution.

38. The wearable automatic injection device of claim 37, wherein the protein comprises any of a fusion protein, an enzyme, an antibody, or an antigen-binding fragment thereof in a solution.

39. The wearable automatic injection device of claim 38, wherein the antibody is a dual specificity antibody.

40. The wearable automatic injection device of claim 1, wherein the therapeutic agent comprises is a TNFα

inhibitor.