Instruments and methods for reducing and stabilizing bone fractures

• US 8,142,462 B2
• Filed: 05/27/2005
• Issued: 03/27/2012
• Est. Priority Date: 05/28/2004
• Status: Active Grant

• Current Assignee: Cavitech LLC
• Original Assignee: Cavitech LLC
• Inventors: Middleton, Lance M.
• Primary Examiner(s): Robert, Eduardo C.
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/140,413
• Publication Number:
  US 20050267483A1
• Time in Patent Office: 2,496 Days
• Field of Search: 606/79, 606 83- 85, 606 92- 94, 606/80, 606/86.R, 606/170, 606/171, 606/178, 606/183, 623/16.11, 623 1711- 1716
• US Class Current: 606/170
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence

Abstract

Instruments and methods for reducing and stabilizing bone fractures are presented. One method provides for cutting a portion of a bone having a fracture to create a cavity, wherein the cavity is substantially axisymmetric, and expanding the volume of the cavity thereby reducing the fracture. The fracture may be further reduced and/or stabilized by adding a material, such as an implant, in-situ curable material and/or in-situ hardenable material.

Claims

1. A method treating bone comprising the steps of:

forming a passage in a vertebra;

forming a cavity in the vertebra by cutting cancellous bone, wherein a first portion of the cavity is defined by a first exposed vertebral endplate, wherein the first exposed vertebral endplate is exposed by cutting cancellous bone, and a second portion of the cavity is defined by a second exposed vertebral endplate, wherein the second exposed vertebral endplate is exposed by cutting cancellous bone;

providing an inflatable device configured for expansion;

introducing the inflatable device configured for expansion into the cavity; and

expanding the inflatable device configured for expansion to provide a distraction force sufficient to reduce a bone fracture.

2. The method of claim 1, wherein the distraction force is applied to the first endplate and the second endplate.

3. The method of claim 2, wherein the distraction force is applied to reduce a vertebral compression fracture.

4. The method of claim 1, wherein the first endplate is a superior endplate and the second endplate is an inferior endplate.

5. The method of claim 1, wherein the step of forming the cavity comprises a method of cutting bone selected from the group consisting of shearing, cutting, scraping, and combinations thereof.

6. The method of claim 1, wherein the inflatable device configured for expansion is a balloon.

7. The method of claim 6, wherein the inflatable device is non-compliant.

8. The method of claim 6, wherein the inflatable device is semi-compliant.

9. The method of claim 1, wherein the step of expanding the inflatable device to provide a distraction force is configured to manipulate cortical bone.

10. The method of claim 9, wherein cortical bone is manipulated to reduce a fracture.

11. The method of claim 1, further comprising a step of filling the cavity with a material.

12. The method of claim 11, wherein the material is a filling material selected from the group consisting of implant material, in-situ curable material, in-situ hardenable material, permanent material, resorbable material, penetrating material, and combinations thereof.

13. The method of claim 1, wherein the step of forming a passage comprises forming a pilot hole about which the cavity is formed.

14. The method of claim 1, wherein the step of forming a cavity by cutting bone further comprises forming the cavity with a flexible cutting element.

15. The method of claim 1, wherein the cavity is substantially axisymmetric.

16. The method of claim 1, wherein the cavity is substantially non-axisymmetric.

17. The method of claim 1, further comprising a step of increasing the volume of the cavity with the device configured for expansion.

18. The method of claim 1, wherein the cavity is formed with rotational actuation of a tissue cavitation device.

19. The method of claim 1, wherein the step of forming a passage in bone precedes the step of forming a cavity.

20. The method of claim 1, wherein the step of forming a passage in bone occurs substantially concomitantly with the step of forming a cavity.

21. A method for treating bone comprising the steps of:

forming a passage in a vertebra along a linear axis;

providing a tissue cavitation device;

forming a cavity in the vertebra with the tissue cavitation device by cutting bone, the cavity including a first exposed region of a vertebral endplate, wherein the first exposed region is centrally located on the vertebral endplate;

providing an inflatable device configured for expansion; and

expanding the inflatable device configured for expansion within the cavity to provide a distraction force sufficient to reduce a bone fracture.

22. The method of claim 21, wherein the distraction force is applied to a region of cortical bone.

23. The method of claim 22, wherein the distraction force is applied directly to the region of cortical bone.

24. The method of claim 21, wherein the cavity is proximate a first region of cortical bone.

25. The method of claim 24, wherein the cavity is proximate a second region of cortical bone, wherein the first region of cortical bone is a superior endplate and the second region of cortical bone is an inferior endplate.

26. The method of claim 24, wherein the cavity is separated from the first region of cortical bone by a layer of cancellous bone.

27. The method of claim 21, wherein a portion of the boundary of the cavity is cortical bone.

28. The method of claim 21, wherein a portion of the boundary of the cavity is cancellous bone.

29. The method of claim 21, wherein the step of forming the cavity is further selected from the group consisting of shearing, scraping, and combinations thereof.

30. The method of claim 21, wherein the inflatable device configured for expansion is a balloon.

31. The method of claim 30, wherein the inflatable device is non-compliant.

32. The method of claim 30, wherein the inflatable device is semi-compliant.

33. The method of claim 21, wherein the step of expanding the inflatable device to provide a distraction force is configured to manipulate cortical bone.

34. The method of claim 33, wherein cortical bone is manipulated to reduce a fracture.

35. The method of claim 21, further comprising a step of filling the cavity with a material.

36. The method of claim 35, wherein the material is a filling material selected from the group consisting of implant material, in-situ curable material, in-situ hardenable material, permanent material, resorbable material, penetrating material, and combinations thereof.

37. The method of claim 21, wherein the step of forming a passage comprises forming a pilot hole about which the cavity is formed.

38. The method of claim 21, where the step of forming a cavity by separating bone further comprises forming the cavity with a flexible cutting element.

39. The method of claim 21, wherein the cavity is substantially axisymmetric.

40. The method of claim 21, wherein the cavity is substantially non-axisymmetric.

41. The method of claim 21, further comprising a step of increasing the volume of the cavity with the device configured for expansion.

42. The method of claim 21, wherein the cavity is formed with rotational actuation of the tissue cavitation device.

43. The method of claim 21, wherein the step of forming a passage precedes the step of forming a cavity.

44. The method of claim 21, wherein the step of forming a passage occurs substantially concomitantly with the step of forming a cavity.

45. A method for treating bone comprising the steps of:

forming a passage in a vertebra;

providing a tissue cavitation device, wherein the tissue cavitation device includes a deformable cutting element;

inserting the tissue cavitation device into the passage;

forming a cavity in the vertebra along cortical bone within a central portion of the vertebra, wherein the cavity is formed with the flexible cutting element of the tissue cavitation device;

providing an inflatable device configured for expansion;

inserting the inflatable device into the cavity formed along cortical bone within the central portion of the vertebra; and

expanding the inflatable device to provide a distraction force.

46. The method of claim 45, wherein the distraction force is applied to a region of cortical bone.

47. The method of claim 46, wherein the distraction force is applied directly to the region of cortical bone.

48. The method of claim 45, wherein the cavity is proximate a first region of cortical bone.

49. The method of claim 48, wherein the cavity is proximate a second region of cortical bone, wherein the first region of cortical bone is a superior endplate and the second region of cortical bone is an inferior endplate.

50. The method of claim 48, wherein the cavity is separated from the first region of cortical bone by a layer of cancellous bone.

51. The method of claim 45, wherein a portion of the boundary of the cavity is cortical bone.

52. The method of claim 45, wherein a portion of the boundary of the cavity is cancellous bone.

53. The method of claim 45, wherein the step of forming the cavity comprises a method of separating bone selected from the group consisting of shearing, cutting, scraping, and combinations thereof.

54. The method of claim 45, wherein the inflatable device configured for expansion is a balloon.

55. The method of claim 54, wherein the inflatable device is non-compliant.

56. The method of claim 54, wherein the inflatable device is semi-compliant.

57. The method of claim 45, wherein the step of expanding the device to provide a distraction force is configured to manipulate cortical bone.

58. The method of claim 57, wherein cortical bone is manipulated to reduce a fracture.

59. The method of claim 45, further comprising a step of filling the cavity with a material.

60. The method of claim 59, wherein the material is a filling material selected from the group consisting of implant material, in-situ curable material, in-situ hardenable material, permanent material, resorbable material, penetrating material, and combinations thereof.

61. The method of claim 45, wherein the step of forming a passage comprises forming a pilot hole about which the cavity is formed.

62. The method of claim 45, wherein the cavity is substantially axisymmetric.

63. The method of claim 45, wherein the cavity is substantially non-axisymmetric.

64. The method of claim 45, further comprising a step of increasing the volume of the cavity with the device configured for expansion.

65. The method of claim 45, wherein the flexible cutting element is transformable between a first shape for passage into tissue and a second shape for cavity formation.

66. The method of claim 45, wherein the tissue cavitation device comprises:

a shaft having a diameter and a longitudinal axis, wherein the flexible cutting element is associated with the shaft, wherein the flexible cutting element is configured to assume a first shape for insertion and configured to assume a second shape suitable for forming a tissue cavity having a diameter greater than the diameter of the shaft when the shaft is rotated about the longitudinal axis of the shaft.

67. The method of claim 45, wherein the cavity is formed with rotational actuation of the tissue cavitation device.

68. The method of claim 45, wherein the step of forming a passage in bone precedes the step of forming a cavity.

69. The method of claim 45, wherein the step of forming a passage in bone occurs substantially concomitantly with the step of forming a cavity.

70. A method for treating bone comprising the steps of:

forming a passage in a vertebra along a linear axis;

providing a tissue cavitation device;

forming a cavity in the vertebra with the tissue cavitation device by separating bone, wherein the cavity is formed with rotational actuation of the tissue cavitation device, the cavity including a first exposed region of a vertebral endplate, wherein the first exposed region is centrally located on the vertebral endplate;

providing an inflatable device configured for expansion; and

expanding the inflatable device configured for expansion within the cavity to provide a distraction force sufficient to reduce a bone fracture.

71. The method of claim 70, wherein the distraction force is applied to a region of cortical bone.

72. The method of claim 71, wherein the distraction force is applied directly to the region of cortical bone.

73. The method of claim 70, wherein the cavity is proximate a first region of cortical bone.

74. The method of claim 73, wherein the cavity is proximate a second region of cortical bone, wherein the first region of cortical bone is a superior endplate and the second region of cortical bone is an inferior endplate.

75. The method of claim 73, wherein the cavity is separated from the first region of cortical bone by a layer of cancellous bone.

76. The method of claim 70, wherein a portion of the boundary of the cavity is cortical bone.

77. The method of claim 70, wherein a portion of the boundary of the cavity is cancellous bone.

78. The method of claim 70, wherein the inflatable device configured for expansion is a balloon.

79. The method of claim 78, wherein the inflatable device is non-compliant.

80. The method of claim 78, wherein the inflatable device is semi-compliant.

81. The method of claim 70, wherein the step of expanding the inflatable device to provide a distraction force is configured to manipulate cortical bone.

82. The method of claim 81, wherein cortical bone is manipulated to reduce a fracture.

83. The method of claim 70, further comprising a step of filling the cavity with a material.

84. The method of claim 83, wherein the material is a filling material selected from the group consisting of implant material, in-situ curable material, in-situ hardenable material, permanent material, resorbable material, penetrating material, and combinations thereof.

85. The method of claim 70, wherein the step of forming a passage comprises forming a pilot hole about which the cavity is formed.

86. The method of claim 70, where the step of forming a cavity by separating bone further comprises forming the cavity with a flexible cutting element.

87. The method of claim 70, wherein the cavity is substantially axisymmetric.

88. The method of claim 70, wherein the cavity is substantially non-axisymmetric.

89. The method of claim 70, further comprising a step of increasing the volume of the cavity with the device configured for expansion.

90. The method of claim 70, wherein the cavity is formed with rotational actuation of the tissue cavitation device.

91. The method of claim 70, wherein the step of forming a passage precedes the step of forming a cavity.

92. The method of claim 70, wherein the step of forming a passage occurs substantially concomitantly with the step of forming a cavity.