FIRING BUTTON FOR AUTOMATIC INJECTION DEVICE

• US 20110178500A1
• Filed: 12/15/2010
• Published: 07/21/2011
• Est. Priority Date: 12/15/2009
• Status: Active Grant

• Current Assignee: AbbVie Biotechnology Ltd. (Puerto Rico) (Abbvie Incorporated)
• Original Assignee: AbbVie Biotechnology Ltd. (Puerto Rico) (Abbvie Incorporated)
• Inventors: Tsvirko, Eduard N., Post, David A., Shang, Sherwin S., Ozdaryal, Esra
• Granted Patent: US 8,758,301 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/3109 Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 2205/583 by visual feedback
• 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 5/3135 characterised by constructional features of the proximal end
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 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 5/3204 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: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Exemplary embodiments provide firing mechanism assemblies that minimize or eliminate a misfire of an automatic injection device that causes a delay in the delivery of an injection. Exemplary embodiments provide automatic injection devices including firing mechanism assemblies that minimize or eliminate a misfire that causes a delay in the delivery of an injection. Exemplary embodiments provide methods for minimizing or eliminating misfire that causes a delay in delivery of an injection in automatic injection devices. Exemplary embodiments provide methods for using automatic injection devices that are free of a misfire that causes delay in delivery of a therapeutic substance into a patient'"'"'s body.

Claims

1. A firing button for use in an automatic injection device, the firing button comprising:

an outer portion configured for contact by a user of the automatic injection device to allow the user to depress the outer portion toward a first end of the automatic injection device; and

an inner ring coupled to the outer portion and provided in proximity to a bifurcated end of a plunger in the automatic injection device, the inner ring configured to engage the bifurcated end of the plunger when the outer portion is depressed by the user, the inner ring having an inner diameter of between 6.0 mm and 6.7 mm.

2. The firing button of claim 1, wherein the outer portion protrudes from a second end of the automatic injection device.

3. The firing button of claim 1, wherein the outer portion covers all or part of the second end of the automatic injection device.

4. The firing button of claim 1, wherein the inner diameter of the inner ring is 6.4 mm.

5. The firing button of claim 1, wherein the inner diameter of the inner ring is 6.5 mm.

6. The firing button of claim 1, wherein the inner diameter of the inner ring is 6.6 mm.

7. The firing button of claim 1, wherein the inner diameter of the inner ring is 6.7 mm.

8. The firing button of claim 1, wherein a length of the inner ring is between 6.73 mm and 6.83 mm.

9. The firing button of claim 1, wherein a length of the inner ring is 6.73 mm.

10. The firing button of claim 1, wherein a length of the inner ring is 6.75 mm.

11. The firing button of claim 1, wherein a length of the inner ring is 6.80 mm.

12. The firing button of claim 1, wherein the firing button avoids a misfiring of the automatic injection device, the misfiring causing a delayed delivery of an injection.

13. The firing button of claim 12, wherein a measure of the delay in the delivery of the injection caused by the misfiring is greater than three seconds.

14. The firing button of claim 1, wherein the inner ring is formed of a thermoplastic material or a thermosetting material.

15. The firing button of claim 1, wherein the outer portion comprises:

an outer tubular wall; and

a planar outer wall coupled to and extending over a terminal end of the outer tubular wall, the planar outer wall being configured for contact by the user.

16. The firing button of claim 1, wherein the inner ring comprises:

a tubular wall with a circular cross-section.

17. The firing button of claim 1, wherein the inner ring has a wall thickness configured to minimize deformation of the inner ring during engagement of the inner ring with the bifurcated end of the plunger.

18. The firing button of claim 17, wherein the wall thickness of the inner ring ranges between 0.6 mm and 2.0 mm.

19. The firing button of claim 17, wherein the wall thickness of the inner ring ranges between 0.8 and 2.0 mm.

20. The firing button of claim 17, wherein the wall thickness of the inner ring is 0.9 mm.

21. The firing button of claim 1, wherein the bifurcated end of the plunger is seated on a surface of a firing body, and wherein engagement of the inner ring with the bifurcated end of the plunger disengages the bifurcated end of the plunger from the surface of the firing body.

22. The firing button of claim 21, wherein subsequent to disengagement of the bifurcated end of the plunger from the surface of the firing body, the plunger transmits an expulsion force to a bung slideably mounted in a syringe, the expulsion force moving the bung to expel a dose from the syringe.

23. The firing button of claim 1, wherein the automatic injection device comprises a dose of a TNFα

inhibitor.

24. The firing button of claim 23, wherein the TNFα

inhibitor is a human TNFα

antibody, or antigen-binding portion thereof.

25. The firing button of claim 24, wherein the human TNFα

antibody, or antigen-binding portion thereof, is adalimumab or golimumab.

26. An automatic injection device having a proximal end configured to deliver a dose of a therapeutic agent and a distal end configured to be controllable by a user, the automatic injection device comprising:

a firing body provided at the distal end of the automatic injection device, the firing body comprising;

a hollow tubular member having a bore, and

a radial surface extending inwardly from a distal portion of the hollow tubular member;

a plunger having a longitudinally extending plunger arm and a radially extending plunger foot, the plunger arm extending through the bore of the hollow tubular member of the firing body, and the plunger foot seated on the radial surface of the firing body; and

a firing button provided at the distal end of the automatic injection device, the firing button comprising;

an inner ring having an inner diameter of between 6.0 mm and 6.7 mm provided in proximity to the plunger foot, the inner ring configured to contact the plunger foot and to disengage the plunger foot from the radial surface of the firing body to allow the plunger to move through the bore of the hollow tubular member of the firing body, when the firing button is activated by the user.

27. The automatic injection device of claim 26, further comprising:

a housing;

a syringe slideably mounted within the housing; and

a bung slideably mounted in the syringe and moveable to expel a dose through a needle provided at the proximal end of the syringe;

wherein the plunger is configured to contact the bung and to transmit an expulsion force thereto.

28. The automatic injection device of claim 26, further comprising:

an actuating bias member operable to move the plunger when released.

29. The automatic injection device of claim 26, further comprising:

a return bias member acting between the housing and a distal end of the syringe to hold the syringe retracted within the housing until the actuating bias member is released.

30. The automatic injection device of claim 26, wherein the inner diameter of the inner ring is 6.4 mm.

31. The automatic injection device of claim 26, wherein the inner diameter of the inner ring is 6.5 mm.

32. The automatic injection device of claim 26, wherein the inner diameter of the inner ring is 6.6 mm.

33. The automatic injection device of claim 26, wherein the inner diameter of the inner ring is 6.7 mm.

34. The automatic injection device of claim 26, wherein a length of the inner ring is 6.73 mm.

35. The automatic injection device of claim 26, wherein a length of the inner ring is greater than 6.73 mm.

36. The automatic injection device of claim 26, wherein a length of the inner ring is 6.75 mm.

37. The automatic injection device of claim 26, wherein a length of the inner ring is between 6.73 mm and 6.83 mm.

38. The automatic injection device of claim 26, wherein a length of the inner ring is 6.80 mm.

39. The automatic injection device of claim 26, wherein a length of the inner ring ranges from 6.73 mm to 6.83 mm.

40. The automatic injection device of claim 26, wherein the inner ring is formed of a thermoplastic material or a thermosetting material.

41. The automatic injection device of claim 26, wherein the firing button further comprises:

an outer portion configured for contact by the user of the automatic injection device to allow the user to depress the outer portion toward the proximal end of the automatic injection device.

42. The automatic injection device of claim 41, wherein the outer portion protrudes from the distal end of the automatic injection device.

43. The automatic injection device of claim 41, wherein the outer portion covers all or part of the distal end of the automatic injection device.

44. The automatic injection device of claim 41, wherein the outer portion of the firing button further comprises:

an outer tubular wall; and

an end wall coupled to a terminal end of the outer tubular wall, the end wall configured for contact by the user.

45. The automatic injection device of claim 26, wherein the inner ring comprises:

a tubular wall with a circular cross-section.

46. The automatic injection device of claim 26, wherein the inner ring is formed of a thermoplastic material or a thermosetting material.

47. The automatic injection device of claim 26, wherein the inner ring has a minimum wall thickness configured to minimize deformation of the inner ring during engagement of the inner ring with the plunger foot.

48. The automatic injection device of claim 47, wherein the minimum wall thickness of the inner ring ranges between 0.6 mm and 2.0 mm.

49. The automatic injection device of claim 47, wherein the minimum wall thickness of the inner ring ranges between 0.8 and 2.0 mm.

50. The automatic injection device of claim 47, wherein the minimum wall thickness of the inner ring is 0.9 mm.

51. The automatic injection device of claim 26, wherein the firing button avoids a misfiring of the automatic injection device, the misfiring causing a delayed delivery of an injection.

52. The automatic injection device of claim 51, wherein a measure of the delay in the delivery of the injection caused by the misfiring is greater than three seconds.

53. The automatic injection device of claim 26, further comprising a dose of a TNFα

inhibitor.

54. The automatic injection device of claim 53, wherein the TNFα

inhibitor is a human TNFα

antibody, or antigen-binding portion thereof.

55. The automatic injection device of claim 54, wherein the human TNFα

antibody, or antigen-binding portion thereof, is adalimumab or golimumab.

56. A firing button for use in an automatic injection device, the firing button comprising:

an outer portion configured for contact by a user of the automatic injection device to allow the user to depress the outer portion toward a first end of the automatic injection device; and

an inner ring coupled to the outer portion and provided in proximity to a bifurcated end of a plunger in the automatic injection device, the inner ring configured to engage the bifurcated end of the plunger when the outer portion is depressed by the user, the inner ring having a minimum wall thickness configured to reduce deformation of the inner ring when the inner ring engages with the bifurcated end of the plunger,

wherein the reduced deformation of the firing button avoids a misfiring of the automatic injection device, the misfiring causing a delayed delivery of an injection.

57. The firing button of claim 56, wherein a measure of the delay in the delivery of the injection is greater than three seconds.

58. The firing button of claim 56, wherein the minimum wall thickness of the inner ring ranges between 0.6 mm and 2.0 mm.

59. The firing button of claim 56, wherein the minimum wall thickness of the inner ring ranges between 0.8 mm and 2.0 mm.

60. The firing button of claim 56, wherein the minimum wall thickness of the inner ring is 0.9 mm.

61. The firing button of claim 56, wherein an inner diameter of the inner ring ranges from 6.0 mm to 6.7 mm.

62. A method of preventing an automatic injection device from misfiring that causes a delay in delivery of an injection, the method comprising:

forming an outer portion of a firing button for contact by a user of the automatic injection device to allow the user to depress the outer portion toward a first end of the automatic injection device;

forming an inner ring of the firing button having an inner diameter of between 6.0 mm and 6.7 mm, the inner ring configured to engage a bifurcated end of a plunger when the outer portion is depressed by the user; and

assembling the inner ring of the firing button in proximity to the bifurcated end of the plunger in the automatic injection device.

63. The firing button of claim 62, wherein the inner diameter of the inner ring is 6.4 mm.

64. The firing button of claim 62, wherein the inner diameter of the inner ring is 6.5 mm.

65. The firing button of claim 62, wherein the inner diameter of the inner ring is 6.6 mm.

66. The firing button of claim 62, wherein the inner diameter of the inner ring is 6.7 mm.

67. The firing button of claim 62, wherein the length of the inner ring is greater than 6.73 mm.

68. The firing button of claim 62, wherein the length of the inner ring is 6.73 mm.

69. The firing button of claim 62, wherein the length of the inner ring is 6.75 mm.

70. The firing button of claim 62, wherein the length of the inner ring ranges from 6.73 mm to 6.83 mm.

71. The firing button of claim 70, wherein the length of the inner ring is 6.80 mm.

72. The firing button of claim 62, wherein forming the outer portion of the firing button comprises:

forming an outer tubular wall;

forming an end wall, the end wall configured for contact by the user; and

coupling the end wall to a terminal end of the outer tubular wall.

73. The firing button of claim 62, further comprising:

configuring the inner ring to have a minimum wall thickness to minimize deformation of the inner ring during engagement of the inner ring with the bifurcated end of the plunger.

74. The firing button of claim 73, wherein the minimum wall thickness of the inner ring ranges between 0.6 mm and 2.0 mm.

75. The firing button of claim 73, wherein the minimum wall thickness of the inner ring ranges between 0.80 mm and 2.0 mm.

76. The firing button of claim 73, wherein the minimum wall thickness of the inner ring is 0.9 mm.

77. A method for forming an automatic injection to prevent misfiring, the method comprising:

providing a firing body at the distal end of the automatic injection device, the firing body comprising a hollow tubular member having a bore and a radial surface extending from a distal portion of the hollow tubular member;

extending a longitudinally extending plunger arm of a plunger through the bore of the hollow tubular member of the firing body;

seating a plunger foot provided at a distal end of the plunger on the radial surface of the firing body; and

providing a firing button at the distal end of the automatic injection device in proximity to the plunger foot, the firing button comprising an inner ring having an inner diameter of between 6.0 mm and 6.7 mm, the inner ring of the firing button configured to contact the plunger foot and to disengage the plunger foot from the radial surface of the firing body to allow the plunger to move through the bore of the hollow tubular member of the firing body, when the firing button is activated by the user.

78. A method for using an automatic injection device to deliver an injection, the method comprising:

depressing a firing button provided at a distal end of the automatic injection device;

engaging an inner ring of the firing button with a plunger foot to disengage the plunger foot from a surface of a firing body, the inner ring having an inner diameter ranging between 6.0 mm and 6.7 mm;

moving the plunger through a bore of a hollow tubular member of the firing body when the plunger foot is disengaged from the firing body;

transmitting an expulsion force to a bung using the moving plunger; and

expelling the dose from a syringe using the expulsion force applied to the bung.