Interspinous process distraction system and method with positionable wing and method

• US 6,695,842 B2
• Filed: 10/26/2001
• Issued: 02/24/2004
• Est. Priority Date: 10/27/1997
• Status: Expired due to Fees

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: St. Francis Medical Technologies, Inc. (Medtronic Plc)
• Inventors: Klyce, Henry A., Zucherman, James F., Winslow, Charles J., Hsu, Ken Y., Flynn, John
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US10/014,118
• Publication Number:
  US 20020091446A1
• Time in Patent Office: 851 Days
• Field of Search: 606/60, 606/61, 623/17.11, 623/17.15, 623/17.16
• US Class Current: 606/249
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/7068 Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
• CPC Class Codes: A61B 17/7071 Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen

Abstract

An implant that is implanted between adjacent spinous processes for the relief of pain associated with the spine. The device has a spacer to distract apart the adjacent spinous processes. To minimize trauma to the patient, the device has a tapered tissue expander to distract a previously created opening between the adjacent spinous processes. The device also has two wings. The position of one wing is adjustable to allow for ease of assembly in a patent.

Claims

1. An implant for maintaining a space between adjacent spinous processes, the implant comprising:

a body, having a spacer and an alignment track;

a wing, having an alignment tab to engage the alignment track on the body; and

a fastening device that secures the wing to the body;

whereby when the fastening device engages the body, the wing travels relative to the alignment track.

2. The implant according to claim 1, whereby the body has a tapered front end for urging between adjacent spinous processes.

3. The implant according to claim 1, wherein the body further contains a first wing.

4. The implant according to claim 3, wherein the first wing on the body and the wing provide lateral support to fix the spacer in place between adjacent spinous processes.

5. The implant according to claim 1, wherein the wing further has a cavity extending through.

6. The implant according to claim 5, wherein the cavity is tapered.

7. The implant according to claim 1, wherein the wing travels along the alignment track as a result of the fastening device traveling in a downward vertical position.

8. The implant according to claim 1, whereby the fastening device is a screw with a tapered head.

9. The implant according to claim 8, whereby the tapered head substantially conforms to a cavity in the wing.

10. The implant according to claim 1, wherein the implant does not require any alteration of the spinous process.

11. The implant according to claim 1, wherein the spacer is substantially elliptical in shape.

12. The implant according to claim 1, wherein the spacer is substantially egg-shaped in cross-section.

13. An implant for maintaining a space between adjacent spinous processes, the implant comprising:

a body, having a spacer adapted to be positioned between adjacent spinous processes, an alignment track, and a first wing element;

a second wing element, having a cavity extending through, and further having an alignment tab to engage the alignment track;

a fastening device that can engage the body, such that when the fastening device is tightened, the second wing travels in the alignment track, towards the first wing.

14. The implant according to claim 13, wherein the fastening device is tightened by traveling vertically downward.

15. The implant according to claim 13, wherein the second wing travels horizontally in the alignment track.

16. The implant according to claim 13, wherein the first and second wing element provide lateral support to fix the body in place between adjacent spinous processes.

17. An implant for maintaining a space between adjacent spinous processes, the implant comprising:

a main body, with a spacer and a tissue expander;

a wing assembly mateable to the main body, having a wing and a screw; and

whereby movement of the screw causes movement of the wing along the body.

18. The implant according to claim 17, wherein the spacer is substantially elliptical in shape.

19. The implant according to claim 17, wherein the spacer is substantially egg-shaped in cross-section.

20. The implant according to claim 17, wherein the tissue expander has a tapered front end for urging between adjacent spinous processes.

21. The implant according to claim 17, wherein the wing has a hole extending through.

22. The implant according to claim 21, wherein the hole is tapered.

23. The implant according to claim 17, wherein the body and the wing provide lateral support to fix the spacer in place between adjacent spinous processes.

24. A method for placing an implant between adjacent spinous processes, the method comprising the steps of:

(a) urging a main body between adjacent spinous processes;

(b) positioning a wing relative to the main body; and

(c) tightening a fastener, so that the wing is attached to the main body, and further wherein the tightening of the fastener causes the wing to travel along the main body.

25. The method according to claim 24, wherein the method does not require any alteration of the spinous processes.

26. The method according to claim 24, wherein the travel of the wing in step (c) is towards the body, so that the wing provides additional lateral support.

27. The method according to claim 24, wherein the main body in step (c) contains a tissue expander, a spacer and a body.

28. The method according to claim 24, wherein positioning the wing relative to the main body in step (b) requires an alignment tab of the wing to be placed within an alignment track on the tissue expander.

29. A method for positioning a spacer between adjacent spinous processes, the method comprising the steps of:

(a) urging a spacer between adjacent spinous process;

(b) attaching a wing element to the spacer;

(c) inserting a fastening device into a cavity of the wing element so that the fastening device engages the spacer;

(d) rotating the fastening device, so that the wing element travels relative to the spacer.

30. The method according to claim 29, wherein the method does not require any alteration of the spinous process.

31. An adjustable device for positioning a spacer between adjacent spinous processes, the device comprising:

a main body;

a spacer;

a tissue expander;

a wing, having a hole through;

a wing adjustment device; and

whereby motion by the wing adjustment device causes the wing to move relative to the main body.

32. The device according to claim 31, wherein the spacer is substantially elliptical in shape.

33. The device according to claim 31, wherein the spacer is substantially egg-shaped in cross-section.

34. The device according to claim 31, wherein the tissue expander has a tapered front end for urging between adjacent spinous processes.

35. The device according to claim 31, wherein the wing adjustment device is a screw with a tapered head.

36. The device according to claim 35, wherein the tapered head substantially conforms to the hole in the wing.

37. The device according to claim 31, wherein the main body and wing element provide lateral support to fix the spacer in place between adjacent spinous processes.

38. The device according to claim 31, wherein the device does not require any alteration of the spinous process.

39. An implant for maintaining a space between adjacent spinous processes, the implant comprising:

a body having a spacer and an alignment track;

a wing, having an alignment tab to engage the alignment track on the body;

a fastening device that secures the wing to the body; and

means for adjusting the wing so that the wing can move relative to the body.

40. The implant according to claim 39, whereby the body has a tapered front end for urging between adjacent spinous processes.

41. The implant according to claim 39, wherein the body further contains a first wing.

42. The implant according to claim 39, wherein the wing further has a cavity extending through.

43. The implant according to claim 42, wherein the cavity is tapered.

44. The implant according to claim 39, wherein the implant does not require any alteration of the spinous process.

45. The implant according to claim 39, wherein the spacer is substantially elliptical in shape.

46. The implant according to claim 39, wherein the spacer is substantially egg-shaped in cross-section.

47. An implant for maintaining a spacer between adjacent spinous processes, the implant comprising:

a body, having a spacer adapted to be positioned between adjacent spinous processes, an alignment track, and a first wing element;

a second wing element, having a cavity extending through, and further having an alignment tab to engage the alignment track;

a fastening device that can engage the body; and

means for adjusting the second wing element so that the first wing element and the second wing element provide lateral support to fix the spacer in place between adjacent spinous processes.

48. The implant according to claim 47, wherein the spacer is substantially elliptical in shape.

49. The implant according to claim 47, wherein the spacer is substantially egg-shaped in cross-section.

50. The implant according to claim 47, wherein the implant does not require any alteration of the spinous process.

51. An adjustable device for rigidly fixing a specer between adjacent spinous processes, the device comprising:

a main body with a first wing element;

a spacer;

a tissue expander;

a second wing element, having a hole through;

a wing adjustment device; and

means for adjusting the second wing element so that the first wing element and the second wing element provide lateral support to fix the spacer in place between adjacent spinous processes.

52. The implant according to claim 51, wherein the spacer is substantially elliptical in shape.

53. The implant according to claim 51, wherein the spacer is substantially egg-shaped in cross-section.

54. The implant according to claim 51, wherein the implant does not require any alteration of the spinous process.

55. An implant for maintaining a space between adjacent spinous processes, the implant comprising:

a body having a spacer;

a wing;

a fastening device that secures the wing to the body; and

whereby when the fastening device engages the body and is rotated, the wing travels relative to the body.

56. An implant for maintaining a space between adjacent spinous processes, the implant comprising:

a body, having a spacer adapted to be positioned between adjacent spinous processes and a first wing element;

a second wing element, having a cavity extending through;

a fastening device that can secure the second wing element to the body, such that when the fastening device is tightened, the second wing element travels towards the first wing.

57. An implant for maintaining a space between adjacent spinous processes, the implant comprising:

a body having a spacer;

a wing, having an alignment tab to engage the alignment track on the body;

a fastening means that secures the wing to the body; and

whereby adjusting the fastening means causes the wing to move relative to the body.