Spine distraction implant

• US 6,068,630 A
• Filed: 10/20/1998
• Issued: 05/30/2000
• Est. Priority Date: 01/02/1997
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/175,645
• Time in Patent Office: 588 Days
• Field of Search: 606/60, 606/61, 606/53, 606/76, 606/78, 606/105, 623/17
• US Class Current: 606/249
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• 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: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen
• CPC Class Codes: Y10S 606/91 Polymer

Abstract

A spine distraction implant alleviates pain associated with spinal stenosis and facet arthropathy by expanding the volume in the spine canal and/or neural foramen. The implant provides a spinal extension stop while allowing freedom of spinal flexion.

Claims

1. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, a guide and a first wing, said first wing located at a first end of said body and said guide extending from a second end of said body located distally from said first wing,

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the first unit.

2. The implant of claim 1 wherein:

said sleeve is cylindrical and is oval in cross-sectional shape.

3. The implant of claim 1 wherein:

said sleeve is cylindrical and has a cross-section with a major dimension and a minor dimension.

4. The implant of claim 3 wherein:

said major dimension is substantially perpendicular to a major length of said first wing.

5. The implant of claim 1 wherein:

said sleeve is comprised of a super-elastic material.

6. The implant of claim 1 wherein:

said sleeve is comprised of a super-elastic alloy of nickel and titanium.

7. The implant of claim 1 wherein:

said central body has at least one elongated groove; and

said sleeve includes at least one inwardly directed spoke which is received in said groove in order to space said sleeve from said body.

8. The implant of claim 7 wherein:

said sleeve has a cross-section with a major dimension and a minor dimension;

said first wing has a major dimension; and

said major dimension of said sleeve is substantially perpendicular to said major dimension of said first wing with said spoke received in said elongated groove.

9. The implant of claim 1 wherein:

said sleeve includes at least one inwardly directed spoke which can contact said central body in order to space said sleeve from said central body.

10. The implant of claim 1 wherein:

said central body has at least one outwardly directed spoke which can contact said sleeve in order to space said sleeve from said central body.

11. The implant of claim 1 wherein:

said guide is pointed in order to allow the central body to be urged between two spinous processes without alteration to the spinous processes.

12. The implant of claim 1 wherein:

said sleeve has a cross-section with a major dimension and a minor dimension and said major dimension is greater than said minor dimension and less than about two times said minor dimension, and said guide has a cross-section which is adjacent to said sleeve with a guide major dimension about equal to said sleeve major dimension and a guide minor dimension about equal to said sleeve minor dimension; and

said guide extends from said central body with a cross-section which reduces in size in a direction away from said central body.

13. The implant of claim 2 wherein:

said guide is cone-shaped with a base located adjacent to said sleeve and having a base cross-section about the same as the oval cross-section of said sleeve.

14. The implant of claim 1 wherein:

said guide is substantially cone-shaped.

15. The implant of claim 1 wherein:

said second wing has a cut-out which is received over said guide.

16. The implant of claim 1 wherein:

said device includes a tab extending from said second wing; and

said device includes a fastener that secures said tab to said guide.

17. The implant of claim 1 wherein:

at least one of said first wing and said second wing is rotated about a major dimension in order to be provided at an acute angle to said central body.

18. The implant of claim 1 wherein:

said device allows said second wing to be secured to said first unit in several configurations such that a spacing between the first and second wing can be selectively varied.

19. The implant of claim 1 wherein:

said central body has cone-shaped ends which hold said sleeve in a spaced relationship from at least a part of said central body such that said sleeve can be deflected toward said at least part of said central body.

20. The implant of claim 1 wherein:

said sleeve is comprised of a material which can absorb about 8% recoverable elongation.

21. The implant of claim 1 wherein:

said sleeve can be deflected at about 20 lbs. to 50 lbs. force.

22. The implant of claim 1 wherein:

said sleeve can be repeatedly deflected and return to a original shape.

23. The implant of claim 1 wherein:

said sleeve can withstand a threshold stress with a small amount of deforming strain and above said threshold stress exhibit substantially instantaneous deformation stress which is many times said small amount of deformation stress.

24. The implant of claim 1 wherein:

said second wing includes upper and lower portions, extending from a middle portion, and at least one of said upper and lower portions is bent relative to said middle portions so as to be closer to the first wing than the middle portion of said second wing is from the first wing.

25. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, a guide located at a first end of the body and a stop located at a second end of the body;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body; and

said sleeve held in place between said guide and said stop.

26. The implant of claim 25 wherein:

said guide is substantially cone-shaped.

27. The implant of claim 25 wherein:

said stop is a first wing.

28. The implant of claim 25 wherein:

said sleeve is oval in cross-sectional shape.

29. The implant of claim 25 wherein:

said sleeve has a cross-section with a major dimension and a minor dimension.

30. The implant of claim 25 wherein:

said sleeve is comprised of a super-elastic material.

31. The implant of claim 25 wherein:

said sleeve is comprised of a super-elastic alloy of nickel and titanium.

32. The implant of claim 25 wherein:

said central elongated body has at least one elongated groove; and

said sleeve includes at least one inwardly directed spoke which is received in said groove in order to space said sleeve from said body.

33. The implant of claim 25 wherein:

said cylindrical sleeve includes at least one inwardly directed spoke which can contact said central body in order to space said sleeve from said central body.

34. The implant of claim 25 wherein:

said central body has at least one outwardly directed spoke which can contact said sleeve in order to space said sleeve from said central body.

35. The implant of claim 25 wherein:

said guide is pointed in order to allow the central body to be urged between two spinous processes without alteration to the spinous processes.

36. The implant of claim 25 wherein:

said sleeve has a cross-section with a major dimension and a minor dimension and said major dimension is greater than said minor dimension and less than about two times said minor dimension, and said guide has a cross-section which is adjacent to said sleeve with a guide major dimension about equal to said sleeve major dimension and a guide minor dimension about equal to said sleeve minor dimension; and

said guide extends from said central body with a cross-section which reduces in size in a direction away from said central body.

37. The implant of claim 28 wherein:

said guide is cone-shaped with a base located adjacent to said sleeve and having a base cross-section about the same as the oval cross-section of said sleeve.

38. The implant of claim 25 wherein:

said central body has cone-shaped ends which hold said sleeve in a spaced relationship from at least a part of said central body such that said sleeve can be deflected toward said at least part of said central body.

39. The implant of claim 25 wherein:

said sleeve is comprised of a material which can absorb about 8% recoverable elongation.

40. The implant of claim 25 wherein:

said sleeve can be deflected at about 20 lbs. to 50 lbs. force.

41. The implant of claim 25 wherein:

said sleeve can be repeatedly deflected and return to a original shape.

42. The implant of claim 25 wherein:

said sleeve can withstand a threshold stress with a small amount of deforming strain and above said threshold stress exhibit substantially instantaneous deformation stress which is many times said small amount of deformation stress.

43. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body and a first wing;

a second wing; and

means for selectively securing the second wing to the central body in a plurality of positions in order to adjust the spacing between the first and second wings in order to be adapted to accommodate spinous processes of different sizes;

said securing means of said second wing has a mid-section with a plurality of ports through which the second wing can be selectively positioned and secured to the central body.

44. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, and a first wing, said first wing located at a first end of said central body, said central body having a second end;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the second end of the central body with the sleeve between the first and second wings; and

said sleeve is oval in cross-sectional shape.

45. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, and a first wing, said first wing located at a first end of said central body, said central body having a second end;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the second end of the central body with the sleeve between the first and second wings; and

said sleeve has a cross-section with a major dimension and a minor dimension.

46. The implant of claim 45 wherein:

said major dimension is substantially perpendicular to a major dimension of said first wing.

47. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, and a first wing, said first wing located at a first end of said central body, said central body having a second end;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the second end of the central body with the sleeve between the first and second wings; and

said sleeve is comprised of a super-elastic material.

48. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, and a first wing, said first wing located at a first end of said central body, said central body having a second end;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the second end of the central body with the sleeve between the first and second wings; and

said sleeve is comprised of a super-elastic alloy of nickel and titanium.

49. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, and a first wing, said first wing located at a first end of said central body, said central body having a second end;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the second end of the central body with the sleeve between the first and second wings; and

said device allows said second wing to be secured to said first unit in several configurations such that a spacing between the first and second wing can be selectively varied.

50. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, and a first wing, said first wing located at a first end of said central body, said central body having a second end;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the second end of the central body with the sleeve between the first and second wings; and

said sleeve is comprised of a material which can absorb about 8% recoverable elongation.

51. An implant for relieving pain associated with at least one of the spinal column and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spinal column, the implant comprising:

a first unit including a central body, and a first wing, said first wing located at a first end of said central body, said central body having a second end;

a sleeve provided over said central body, said sleeve at least partially spaced from said central body in order to allow for the deflection of said sleeve toward said central body;

a second wing; and

a device that secures the second wing to the second end of the central body with the sleeve between the first and second wings; and

said sleeve can withstand a threshold stress with a small amount of deforming strain and above said threshold stress exhibit about substantially instantaneous deformation stress which is many times said small amount of deformation stress.