WEARABLE AUTOMATIC INJECTION DEVICE FOR CONTROLLED ADMINISTRATION OF THERAPEUTIC AGENTS

• US 20140148784A1
• Filed: 04/23/2012
• Published: 05/29/2014
• Est. Priority Date: 04/21/2011
• Status: Active Grant

• Current Assignee: Abbvie Incorporated
• Original Assignee: Abbvie Incorporated
• Inventors: Anderson, Philip D., Julian, Joseph F., Laurusonis, Linas P., Corrigan, Sean, Matusaitis, Tomas, Fienup, William, Strahm, Chris
• Granted Patent: US 9,956,345 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• 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 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• 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 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

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

Claims

1. A wearable automatic injection device for administering a therapeutic agent to a patient, the wearable automatic injection device comprising:

a housing comprising a patient contact portion for contacting the patient;

an administration assembly moveably disposed in the housing holding an administration interface for administering the therapeutic agent to the patient, the administration assembly moveable between a retracted position in which the administration interface does not protrude outside the housing and an extended position in which the administration interface protrudes outside the housing;

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

a plunger actuation mechanism moveably disposed in the vessel for ejecting the therapeutic agent from the vessel into the administration assembly;

wherein a volume of the therapeutic agent of between 0.1 milliliters and 1.0 milliliter is ejected from the vessel in less than thirty seconds.

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

a retraction trigger responsive to a change of state of the wearable automatic injection device from an administration state to a post-administration state; and

a retraction mechanism for automatically retracting the administration assembly from the extended position in the administration state to the retracted position in the post-administration state upon triggering by the retraction trigger.

3. The wearable automatic injection device of claim 1, wherein the vessel comprises a syringe.

4. The wearable automatic injection device of claim 3, wherein the syringe comprises:

a barrel portion for holding the therapeutic agent; and

a piercing needle coupled to a distal end of the barrel portion for establishing fluid communication between the barrel portion of the syringe and the administration assembly.

5. The wearable automatic injection device of claim 4, wherein the administration assembly comprises:

a septum that is pierceable by the piercing needle of the syringe; and

a fluid conduit extending between the administration interface and the septum, wherein piercing of the septum by the piercing needle of the syringe couples the barrel to portion of the syringe and the administration interface.

6. The wearable automatic injection device of claim 5, wherein the piercing needle of the syringe is spaced from the septum when the device is in a pre-administration state, and wherein the piercing needle pierces the septum when the device is in an administration state.

7. The wearable automatic injection device of claim 1, wherein the vessel comprises a cartridge.

8. The wearable automatic injection device of claim 7, wherein the cartridge comprises:

a barrel portion for holding the therapeutic agent; and

a septum that is pierceable by a piercing needle.

9. The wearable automatic injection device of claim 8, wherein the administration assembly comprises:

the piercing needle for establishing fluid communication between the barrel portion of the cartridge and the administration interface; and

a fluid conduit provided between the administration interface and the piercing needle for establishing fluid communication between the administration interface and the barrel portion of the cartridge.

10. The wearable automatic injection device of claim 9, wherein piercing of the septum by the piercing needle of the administration assembly establishes fluid communication between the barrel portion of the cartridge and the administration interface.

11. The wearable automatic injection device of claim 10, wherein the septum of the cartridge is spaced from the piercing needle of the administration assembly when the device is in a pre-administration state, and wherein the piercing needle pierces the to septum when the device is in an administration state.

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

13. The wearable automatic injection device of claim 12, wherein the vessel is moveable between a first position in a pre-administration state and a second position in an administration state.

14. The wearable automatic injection device of claim 13, further comprising:

a vessel actuator for automatically actuating the vessel from the first position to the second position.

15. The wearable automatic injection device of claim 14, wherein a fluid pathway is established between the administration assembly and the vessel, when the administration assembly is in the extended position and the vessel is in the second position in the administration state.

16. The wearable automatic injection device of claim 1, wherein the plunger actuation mechanism administers the therapeutic agent to the patient at a controlled linear rate.

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

a plunger configured to exert an expulsion force to the therapeutic agent in the vessel;

a source of a working fluid for providing a hydraulic pressure to the plunger; and

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

18. The wearable automatic injection device of claim 17, wherein the plunger actuation mechanism further comprises:

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

19. The wearable automatic injection device of claim 18, wherein the damping to mechanism comprises a flow restrictor for maintaining a first hydraulic pressure downstream of the flow restrictor toward the vessel at a lower pressure than a second hydraulic pressure upstream of the flow restrictor toward the source of the working fluid.

20. The wearable automatic injection device of claim 19, wherein the flow restrictor is coupled to a retraction trigger, wherein administration of the therapeutic agent in the vessel causes the flow restrictor to activate the retraction trigger, and wherein activation of the retraction trigger automatically retracts the administration assembly from the extended position to the retracted position.

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

an administration interface locking mechanism for automatically locking the administration interface in the retracted position within the housing in a pre-administration state and a post-administration state.

22. The wearable automatic injection device of claim 21, wherein the administration interface locking mechanism comprises:

a barrier mechanism moveably disposed over an administration interface aperture in the housing;

wherein the administration interface aperture allows the administration interface to protrude outside the housing when the barrier mechanism is in a first position; and

wherein the administration interface aperture prevents the administration interface from protruding outside the housing when the barrier mechanism is in a second position.

23. The wearable automatic injection device of claim 21, wherein the administration interface locking mechanism comprises:

an administration interface lock release mechanism responsive to retraction of the administration assembly from the extended position in the administration state to the to retraction position in the post-administration state; and

a pivoting member coupled to the administration interface and to the administration interface lock release mechanism;

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

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

inhibitor.

25. The wearable automatic injection device of claim 1, wherein, after insertion of the therapeutic agent in the vessel, a sterility barrier is maintained around the therapeutic agent contained in the vessel and an administration pathway taken by the therapeutic agent during administration to the patient.

26. The wearable automatic injection device of claim 25, wherein aseptic assembly of the automatic injection device is not required for maintaining sterility of the therapeutic agent, one or more skin penetrating surfaces of the administration interface and the administration pathway taken by the therapeutic agent during administration to the patient.

27. The wearable automatic injection device of claim 25, wherein the sterility barrier is provided by:

a sterile barrel portion of the vessel for holding the therapeutic agent;

a sterile piercing needle for establishing a fluid conduit between the barrel portion of the vessel and the administration interface;

a sterile septum of the administration assembly that is pierceable by the piercing needle;

a sterile fluid conduit of the administration assembly extending between the administration interface and the septum, wherein piercing of the septum by the piercing needle of the vessel establishes fluid communication between the barrel portion of the vessel and the administration interface; and

the administration interface which is sterile.

28. The wearable automatic injection device of claim 27, further comprising:

a septum cover for covering and maintaining sterility of the septum;

an administration interface cover for covering and maintaining sterility of the administration interface and the fluid conduit coupled to the administration interface; and

a piercing needle cover for covering and maintaining sterility of the piercing needle and the fluid conduit coupled to the piercing needle.

29. The wearable automatic injection device of claim 28, further comprising:

a protective film attached to at least a portion of the housing, the protective film coupled to the septum cover, the administration interface cover and the piercing needle cover such that removal of the protective film from the housing automatically removes the septum cover, the administration interface cover and the piercing needle cover.

30. The wearable automatic injection device of claim 29, wherein the protective film comprises:

an attachment mechanism attached to a package holding the automatic injection device such that removal of the device from the package removes the protective film from the housing of the device, the removal of the protective film removing the septum cover, the administration interface cover and the piercing needle cover.

31. The wearable automatic injection device of claim 29, wherein the protective film comprises:

a removal mechanism configured to be pulled in order to remove the protective to film from the housing of the device, the removal of the protective film removing the septum cover, the administration interface cover and the piercing needle cover.

32. The wearable automatic injection device of claim 1, wherein the administration interface is a needle-free patch.

33. A method for administering a therapeutic agent to a patient, the method comprising:

providing a wearable automatic injection device, comprising;

a housing comprising a patient contact portion for contacting the patient,

an administration assembly moveably disposed in the housing holding an administration interface for administering the therapeutic agent to the patient, the administration assembly moveable between a retracted position in which the administration interface does not protrude outside the housing and an extended position in which the administration interface protrudes outside the housing,

a vessel provided in the housing for holding the therapeutic agent, and

a plunger actuation mechanism moveably disposed in the vessel for ejecting the therapeutic agent from the vessel into the administration assembly,

securing the wearable automatic injection device to the body of the patient or an article of clothing on the patient using the patient contact portion of the housing; and

administering a volume of the therapeutic agent of between 0.1 milliliters and 1.0 milliliter to the body of the patient using the wearable automatic injection device in less than thirty seconds.

34. The method of claim 33, wherein the wearable automatic injection device further comprises:

a retraction trigger responsive to a change of state of the wearable automatic injection device from an administration state to a post-administration state; and

a retraction mechanism for automatically retracting the administration assembly from the extended position in the administration state to the retracted position in the post-administration state upon triggering by the retraction trigger.

35. The method of claim 33, wherein the vessel comprises a syringe.

36. The method of claim 35, wherein the syringe comprises:

a barrel portion for holding the therapeutic agent; and

a piercing needle coupled to a distal end of the barrel portion for establishing fluid communication between the barrel portion of the syringe and the administration assembly.

37. The method of claim 36, wherein the administration assembly comprises:

a septum that is pierceable by the piercing needle of the syringe; and

a fluid conduit extending between the administration interface and the septum, wherein piercing of the septum by the piercing needle of the syringe couples the barrel portion of the syringe and the administration interface.

38. The method of claim 37, wherein the piercing needle of the syringe is spaced from the septum when the device is in a pre-administration state, and wherein the piercing needle pierces the septum when the device is in an administration state.

39. The method of claim 33, wherein the vessel comprises a cartridge.

40. The method of claim 39, wherein the cartridge comprises:

a barrel portion for holding the therapeutic agent; and

a septum that is pierceable by a piercing needle.

41. The method of claim 40, wherein the administration assembly comprises:

the piercing needle for establishing fluid communication between the barrel portion of the cartridge and the administration interface; and

a fluid conduit provided between the administration interface and the piercing needle for establishing fluid communication between the administration interface and the barrel portion of the cartridge.

42. The method of claim 41, wherein piercing of the septum by the piercing needle of the administration assembly establishes fluid communication between the barrel portion of the cartridge and the administration interface.

43. The method of claim 42, wherein the septum of the cartridge is spaced from the piercing needle of the administration assembly when the device is in a pre-administration state, and wherein the piercing needle pierces the septum when the device is in an administration state.

44. The method of claim 33, wherein the plunger actuation mechanism administers the therapeutic agent to the patient at a controlled linear rate.

45. The method of claim 33, wherein the plunger actuation mechanism further comprises:

a plunger configured to exert an expulsion force to the therapeutic agent in the vessel;

a source of a working fluid for providing a hydraulic pressure to the plunger; and

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

46. The method of claim 45, wherein the plunger actuation mechanism further comprises:

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

47. The method of claim 46, wherein the damping mechanism comprises a flow restrictor for maintaining a first hydraulic pressure downstream of the flow restrictor toward the vessel at a lower pressure that a second hydraulic pressure upstream of the flow restrictor toward the source of the working fluid.

48. The method of claim 47, wherein the flow restrictor is coupled to a retraction to trigger, wherein administration of the therapeutic agent in the vessel causes the flow restrictor to activate the retraction trigger, and wherein activation of the retraction trigger automatically retracts the administration assembly from the extended position to the retracted position.

49. The method of claim 33, wherein the wearable automatic injection device further comprises:

an administration interface locking mechanism for automatically locking the administration interface in the retracted position within the housing in a post-administration state.

50. The method of claim 49, wherein the administration interface locking mechanism comprises:

a barrier mechanism moveably disposed over an administration interface aperture in the housing;

wherein the administration interface aperture allows the administration interface to protrude outside the housing when the barrier mechanism is in a first position; and

wherein the administration interface aperture prevents the administration interface from protruding outside the housing when the barrier mechanism is in a second position.

51. The method of claim 49, wherein the administration interface locking mechanism comprises:

an administration interface lock release mechanism responsive to retraction of the administration assembly from the extended position in an administration state to the retraction position in the post-administration state; and

a pivoting member coupled to the administration interface and to the administration interface lock release mechanism;

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

52. A method for assembling a wearable automatic injection device, the method comprising:

assembling a first portion of the automatic injection device in a sterile environment to hold a sterile dose of a therapeutic agent;

providing one or more sterility barrier components associated with the first portion of the device to maintain sterility, during and after assembly of the automatic injection device, of a fluid pathway taken by the therapeutic agent during administration to a patient; and

assembling a second portion of the automatic injection device in a non-sterile environment.

53. The method of claim 52, wherein assembling the first portion of the device comprises:

assembling an administration assembly in a housing of the automatic injection device for holding a sterile administration interface for administering the therapeutic agent to a patient, the administration assembly moveable between a retracted position in which the administration interface does not protrude outside the housing of the device and an extended position in which the administration interface protrudes outside the housing of the device; and

assembling a vessel in the housing of the device for holding the therapeutic agent.

54. The method of claim 53, wherein the vessel is a syringe.

55. The method of claim 54, wherein assembling the syringe comprises:

providing a sterile barrel portion of the syringe for holding the therapeutic agent;

sealing a proximal portion of the barrel portion using a sterile bung;

coupling a sterile piercing needle to a distal end of the barrel portion for establishing fluid communication between the barrel portion of the syringe and the administration interface; and

covering the sterile piercing needle with a sterile piercing needle cover;

wherein the sterile barrel portion, the sterile bung, the sterile piercing needle and the sterile piercing needle cover provide sterility barriers to maintain sterility of a fluid pathway in the syringe during and after assembly of the automatic injection device.

56. The method of claim 55, wherein assembling the administration assembly comprises:

providing the sterile administration interface with a sterile administration interface cover;

providing a sterile septum that is pierceable by the piercing needle of the syringe;

covering the sterile septum with a sterile septum cover for maintaining sterility of the sterile septum; and

providing a sterile fluid conduit extending between the sterile administration interface and the sterile septum, wherein piercing of the septum by the piercing needle of the syringe couples the barrel portion of the syringe and the administration interface;

wherein the sterile administration interface, the sterile administration interface cover, the sterile septum, the sterile septum cover and the sterile fluid conduit provide sterility barriers to maintain sterility of a fluid pathway in the administration assembly during and after assembly of the automatic injection device.

57. The method of claim 53, wherein the vessel is a cartridge.

58. The method of claim 57, wherein assembling the cartridge comprises:

providing a sterile barrel portion for holding the therapeutic agent;

sealing a proximal portion of the barrel portion using a sterile bung;

coupling a sterile septum that is pierceable by a sterile piercing needle to a distal end of the barrel portion; and

covering the sterile septum with a sterile septum cover;

wherein the sterile barrel portion, the sterile bung, the sterile septum and the sterile septum cover provide sterility barriers to maintain sterility of a fluid pathway in the cartridge during and after assembly of the automatic injection device.

59. The method of claim 58, wherein assembling the administration assembly comprises:

covering the sterile administration interface with a sterile administration interface cover;

coupling the sterile piercing needle to a proximal portion of the administration assembly for establishing fluid communication between the barrel portion of the cartridge and the administration interface;

covering the sterile piercing needle with a sterile piercing needle cover; and

providing a sterile fluid conduit provided between the sterile administration interface and the sterile piercing needle for establishing fluid communication between the administration interface and the barrel portion of the cartridge;

wherein the sterile administration interface, the sterile administration interface cover, the sterile piercing needle, the sterile piercing needle cover and the sterile fluid conduit provide sterility barriers to maintain sterility of a fluid pathway in the administration assembly during and after assembly of the automatic injection device.

60. The method of claim 52, wherein, after insertion of the dose of the therapeutic agent into the first portion of the automatic injection device, a sterility barrier is maintained around the therapeutic agent contained in the device and the fluid pathway taken by the therapeutic agent during administration to the patient.

61. The method of claim 60, wherein aseptic assembly of the second portion of the automatic injection device is not required for maintaining the sterility barrier around the therapeutic agent contained in the device and the fluid pathway taken by the therapeutic agent during administration to the patient.