MINIMALLY INVASIVE ACTUABLE BONE FIXATION DEVICES

• US 20070233105A1
• Filed: 11/30/2006
• Published: 10/04/2007
• Est. Priority Date: 05/18/2005
• Status: Active Grant

• Current Assignee: Arthrex Incorporated
• Original Assignee: Sonoma Orthopedic Products Incorporated (Arthrex Incorporated)
• Inventors: Saravia, Heber, Nelson, Charles, Mazur, Kai
• Granted Patent: US 7,914,533 B2
• Time in Patent Office: Days
• US Class Current: 606/64
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 17/7241 the nail having separate elements through which screws pass
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive

Abstract

Apparatus for bone reinforcement, fixation and treatment of diseased or fractured bones including a supporting structure optionally coated with therapeutic agent is provided. The supporting structure or device may be collapsible upon deployment at the surgical site, and include fixation features such as anchors to securely position in place once deployed. Bone cement or other material may be provided to alternatively secure the positioned supporting structure for treatment. A lockable bone fixation device is described that comprises: a sleeve adapted to be positioned in a space formed in a bone; a guidewire adapted to guide movement of the sleeve; and an actuable lock adapted to secure the sleeve within the space of the bone from an end of the device.

Claims

1. In a system for treating a fracture site in a bone having an intramedullary canal, a structural frame characterized by:

an elongate size and shape suitable for insertion into said canal;

a length sufficient to span said fracture site; and

a contour adapted to engage an internal surface of said canal.

2. The structural frame of claim 1, further characterized in that said structural frame is expandable from a first cross-sectional size to a second cross-sectional size which is larger than said first size.

3. The structural frame of claim 2, further characterized in that said structural frame is biased toward expansion to said second size, such that said structural frame requires a retainer in order to remain at said first size.

4. The structural frame of claim 2, further characterized in that said structural frame is configured to receive an expandable member which, upon expansion, expands said structural frame from said first size to said size.

5. The structural frame of claim 2, further characterized in that, after expansion, said structural frame is collapsible from said second size to said first size.

6. The structural frame of claim 2, further characterized in that, after expansion, said structural frame is collapsible from said second size to said first size and retrievable from said canal.

7. The structural frame of claim 2, further characterized in that said structural frame is biased toward remaining at said second size once expanded.

8. The structural frame of claim 2, further characterized in that said structural frame resists collapsing forces once expanded to said second size.

9. The structural frame of claim 2, further characterized by a locking member configured to maintain said structural frame at said second size and resist collapsing forces.

10. The structural frame of claim 1, further characterized by a generally hollow, substantially tubular shape.

11. The structural frame of claim 1, further characterized in that said structural frame is made of a biocompatible material.

12. The structural frame of claim 1, further characterized in that said structural frame is made of a bioabsorbable material.

13. The structural frame of claim 1, further characterized in that said structural frame carries a therapeutic agent.

14. The structural frame of claim 1, further characterized by a plurality of discrete components nested together.

15. The structural frame of claim 1, further characterized by a plurality of elongate members connected to one another by one or more linking members.

16. The structural frame of claim 1, further characterized by:

a generally central elongate shaft; and

a plurality of other elongate members, each connected to said shaft by one or more linking members.

17. The structural frame of claim 1, further characterized by:

a generally central elongate shaft sized and shaped to receive a guide wire having near its distal end one or more fins disposed thereon;

a plurality of other elongate members, each connected to said shaft by one or more linking members;

said one or more linking members positioned such that distal motion against said one or more fins urges said plurality of other elongate members away from said shaft, thereby expanding said structural frame.

18. The structural frame of claim 1, further characterized by a plurality of prongs configured to engage an internal surface of said canal.

19. The structural frame of claim 1, further characterized in that said structural frame is sized and shaped to receive a sheath along at least a portion of the length of said structural frame, said sheath having a length sufficient to span said fracture site.

20. The structural frame of claim 1, further characterized by:

an elongate size and shape suitable for engagement with a prosthesis in said canal;

a length sufficient to span a periprosthetic fracture site and engage said prosthesis.

21. The structural frame of claim 1, further characterized by:

an extension member having a first end connected to said structural frame and a generally opposing second end sized and shaped for engagement with a prosthesis in said canal.

22. The structural frame of claim 1, further characterized by a strain gage positioned across said fracture site, a transmitter, and a receiver.

23. The structural frame of claim 1, further characterized by an electrical osteogenic stimulator positioned near said fracture site.

24. In a system for treating a fracture site in a bone having an intramedullary canal, a sheath characterized by:

a size and shape suitable for insertion into said canal;

a length sufficient to span said fracture site; and

an elongate tubular structure sized and shaped to receive a structural frame extending through said canal.

25. The sheath of claim 24, further characterized in that said elongate tubular structure is sized and shaped to allow a portion of said structural frame to extend through and beyond each end of said sheath, said structural frame having a contour adapted to engage an internal surface of said canal.

26. The sheath of claim 24, further characterized in that said elongate tubular structure is sized and shaped to be received within said structural frame.

27. The sheath of claim 24, further characterized in that said sheath is made of an elastic material.

28. The sheath of claim 24, further characterized in that said sheath is made of a material defining a plurality of pores,

said pore size selected to be substantially impermeable to a surgical fluid, thereby reducing intrusion of said fluid into said fracture site.

29. The sheath of claim 24, further characterized by a plurality of layers.

30. The sheath of claim 24, further characterized in that said sheath is made of a biocompatible material.

31. The sheath of claim 24, further characterized in that said sheath is made of a osteoconductive material.

32. The sheath of claim 24, further characterized in that said sheath is made of a osteoinductive material.

33. The sheath of claim 24, further characterized in that said sheath is made of a bioabsorbable material.

34. The sheath of claim 24, further characterized in that said sheath carries a therapeutic agent.

35. The sheath of claim 24, further characterized in that said sheath carries a therapeutic agent disposed in an outer surface of said sheath.

36. The sheath of claim 24, further characterized in that said sheath carries a therapeutic agent disposed in a three-dimensional matrix throughout said sheath.

37. A system for treating a fracture site in a bone having an intramedullary canal, said system characterized in that it comprises:

a structural frame having a size and shape suitable for insertion into said canal, having a length sufficient to span said fracture site, and having a contour adapted to engage an internal surface of said canal; and

a sheath having a size and shape suitable for insertion into said canal, having a length sufficient to span said fracture site, and having an elongate tubular structure sized and shaped to receive said structural frame.

38. The system of claim 37, further characterized in that said sheath covers at least a portion of the length of said structural frame, such that said sheath spans said fracture site.

39. The system of claim 37, further characterized in that said sheath may be placed within said structural frame along at least a portion of the length of said structural frame, such that said sheath spans said fracture site.

40. The system of claim 37, further characterized in that said sheath is made of an elastic material to accommodate expansion of said structural frame.

41. The system of claim 37, further characterized by a generally hollow, substantially tubular shape.

42. The system of claim 37, further characterized in that said system carries a therapeutic agent.

43. The system of claim 37, further characterized by a plurality of prongs sized and shaped to engage an internal surface of said canal.

44. The system of claim 37, further characterized in that said structural frame is expandable from a first cross-sectional size to a second cross-sectional size which is larger than said first size.

45. The system of claim 44, further characterized in that said structural frame is biased toward expansion to said second size, such that said structural frame requires a retainer in order to remain at said first size.

46. The system of claim 44, further characterized in that said structural frame is configured to receive an expandable member which, upon expansion, expands said structural frame from said first size to said size.

47. The system of claim 44, further characterized in that, after expansion, said structural frame is collapsible from said second size to said first size.

48. The system of claim 44, further characterized in that, after expansion, said structural frame is collapsible from said second size to said first size and retrievable from said canal.

49. The system of claim 44, further characterized in that said structural frame is biased toward remaining at said second size once expanded.

50. The system of claim 44, further characterized in that said structural frame resists collapsing forces once expanded to said second size.

51. The system of claim 44, further characterized in that said structural frame includes a locking member configured to maintain said structural frame at said second size and resist collapsing forces.

52. The system of claim 37, further characterized in that said structural frame has an elongate size and shape suitable for engagement with a prosthesis in said canal, and has a length sufficient to span a periprosthetic fracture site and engage said prosthesis.

53. The system of claim 37, further characterized in that said structural frame an extension member having a first end connected to said structural frame and a generally opposing second end sized and shaped for engagement with a prosthesis in said canal.

54. The system of claim 37, further characterized by:

a strain gage connected to said structural frame and positioned across said fracture site, a transmitter, and a receiver.

55. The system of claim 37, further characterized by an electrical osteogenic stimulator positioned near said fracture site.

56. The system of claim 37, further characterized in that said structural frame comprises:

a generally central elongate shaft sized and shaped to receive a guide wire having near its distal end one or more fins disposed thereon;

a plurality of other elongate members, each connected to said shaft by one or more linking members,

said one or more linking members positioned such that distal motion against said one or more fins urges said plurality of other elongate members away from said shaft, thereby expanding said structural frame.

57. The system of claim 37, further characterized in that said sheath is made of a material defining a plurality of pores;

said pore size selected to be substantially impermeable to a surgical fluid, thereby reducing intrusion of said fluid into said fracture site.

58. A system for treating a fracture site in a bone having an intramedullary canal, said system characterized in that it comprises:

a structural frame having a size and shape suitable for insertion into said canal, having a length sufficient to span said fracture site, and having a contour adapted to engage an internal surface of said canal;

a sheath having a size and shape suitable for insertion into said canal, having a length sufficient to span said fracture site, and having an elongate tubular structure sized and shaped to receive said structural frame; and

a hardenable surgical fluid cooperative with said structural frame to provide additional support across said fracture site.

59. The system of claim 58, further characterized in that said hardenable surgical fluid substantially fills the space within said sheath and substantially fills at least a portion of the length of said structural frame.

60. The system of claim 58, further characterized in that said sheath is made of a material defining a plurality of pores,

said pore size selected to be substantially impermeable to said surgical fluid, thereby reducing intrusion of said fluid into said fracture site.

61. The system of claim 58, further characterized in that said sheath covers at least a portion of the length of said structural frame, such that said sheath spans said fracture site.

62. The system of claim 58, further characterized in that said sheath may be placed within said structural frame along at least a portion of the length of said structural frame, such that said sheath spans said fracture site.

63. The system of claim 58, further characterized in that said sheath is made of an elastic material to accommodate expansion of said structural frame.

64. The system of claim 58, further characterized in that said structural frame and sheath together form a generally hollow, substantially tubular shape capable of receiving an injection of said hardenable surgical fluid.

65. The system of claim 58, further characterized in that it comprises:

a restrictor placed at a site within said canal, sized and shaped to restrict a quantity of said hardenable surgical fluid from extending beyond said site.

66. The system of claim 58, further characterized in that said system carries a therapeutic agent.

67. The system of claim 58, further characterized by a plurality of prongs sized and shaped to engage an internal surface of said canal.

68. The system of claim 58, further characterized in that said structural frame is expandable from a first cross-sectional size to a second cross-sectional size which is larger than said first size.

69. The system of claim 68, further characterized in that said structural frame is biased toward expansion to said second size, such that said structural frame requires a retainer in order to remain at said first size.

70. The system of claim 68, further characterized in that said structural frame is configured to receive an expandable member which, upon expansion, expands said structural frame from said first size to said size.

71. The system of claim 68, further characterized in that, after expansion, said structural frame is collapsible from said second size to said first size.

72. The system of claim 68, further characterized in that, after expansion, said structural frame is collapsible from said second size to said first size and retrievable from said canal.

73. The system of claim 68, further characterized in that said structural frame is biased toward remaining at said second size once expanded.

74. The system of claim 68, further characterized in that said structural frame resists collapsing forces once expanded to said second size.

75. The system of claim 68, further characterized in that said structural frame includes a locking member configured to maintain said structural frame at said second size and resist collapsing forces.

76. The system of claim 68, further characterized in that said structural frame and said hardenable surgical fluid together resist collapsing forces once said frame is expanded to said second size.

77. The system of claim 58, further characterized in that said structural frame has an elongate size and shape suitable for engagement with a prosthesis in said canal, and has a length sufficient to span a periprosthetic fracture site and engage said prosthesis.

78. The system of claim 58, further characterized in that said structural frame an extension member having a first end connected to said structural frame and a generally opposing second end sized and shaped for engagement with a prosthesis in said canal.

79. The system of claim 58, further characterized by:

a strain gage connected to said structural frame and positioned across said fracture site, a transmitter, and a receiver.

80. The system of claim 58, further characterized by an electrical osteogenic stimulator positioned near said fracture site.

81. The system of claim 58, further characterized in that said structural frame comprises:

a generally central elongate shaft sized and shaped to receive a guide wire having near its distal end one or more fins disposed thereon;

a plurality of other elongate members, each connected to said shaft by one or more linking members,

said one or more linking members positioned such that distal motion against said one or more fins urges said plurality of other elongate members away from said shaft, thereby expanding said structural frame.