Spine distraction implant

• US 6,332,882 B1
• Filed: 12/28/1999
• Issued: 12/25/2001
• 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): REIP, DAVID OWEN
• Application Number:
  US09/474,038
• Time in Patent Office: 728 Days
• Field of Search: 606/60, 606/61, 606/63, 606/68, 606/72, 606/76, 606/78, 623/17.11
• US Class Current: 606/86.00A
• 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 for prostheses A61F2210/0014
• 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 system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve which is inwardly deflectable;

an insertion tool including an insertion guide, a central body, a stop and a handle, wherein said guide and said stop extend from opposite sides of said central body and said handle extends from said stop; and

wherein said sleeve fits over said guide and against said stop preparatory to being positioned between two adjacent spinous processes with the insertion tool.

2. The implant of claim 1 wherein:

said guide is substantially cone-shaped.

3. The implant of claim 1 including:

said sleeve has first and second ends, a longitudinal axis, and at least one flexible wire which is positioned through the sleeve and said wire having portions which extends out both of said first end and said second end; and

said portions of said flexible wire being non-parallel to said longitudinal axis.

4. The implant of claim 1 wherein:

said sleeve is oval in cross-sectional shape.

5. The implant of claim 1 wherein:

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

6. The implant of claim 1 wherein:

said sleeve is comprised of a super-elastic material.

7. The implant of claim 1 wherein:

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

8. 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.

9. The implant of claim 1 wherein:

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

10. The implant of claim 1 wherein:

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

11. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve which is inwardly deflectable, which sleeve is positionable between two adjacent spinous process, and an insertion guide wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said sleeve is comprised of a super-elastic material.

12. The implant of claim 11 wherein:

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

13. The implant of claim 11 wherein:

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

14. The system of claim 11 wherein:

said insertion guide is removable after the sleeve is implanted between the spinous process.

15. The implant of claim 11 wherein:

said guide is substantially cone-shaped.

16. The implant of claim 11 wherein:

said sleeve is comprised of a super-elastic material.

17. The implant of claim 11 wherein:

said sleeve is oval in cross-sectional shape.

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

a sleeve which is inwardly deflectable, which sleeve is positionable between two adjacent spinous processes;

said sleeve is comprised of a super-elastic material;

said sleeve has first and second ends, a longitudinal axis, and at least one flexible wire which is positioned through the sleeve and said wire having portions which extend out both of said first end and said second end; and

said portions of said flexible wire being non-parallel to said longitudinal axis.

19. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion tool including an insertion guide, a central body, a stop and a handle, wherein said guide and said stop extend from opposite sides of said central body and said handle extends from said stop; and

wherein said sleeve fits over said guide and against said stop preparatory to being positioned between two adjacent vertebrae with the insertion tool.

20. The system of claim 19 wherein:

said sleeve is comprised of a super-elastic material.

21. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve which is positionable between two adjacent spinous process, and an insertion guide wherein said insertion guide is extended from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said sleeve is comprised of a super-elastic material.

22. The system of claim 21 wherein:

said insertion guide is removable after the sleeve is implanted between the spinous process.

23. The implant of claim 21 wherein:

said guide is substantially cone-shaped.

24. The implant of claim 21 wherein:

said sleeve is comprised of a super-elastic material.

25. The implant of claim 21 wherein:

said sleeve is oval in cross-sectional shape.

26. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion tool including an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said insertion guide is removable after the sleeve is implanted between the spinous process.

27. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion tool including an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said guide is substantially cone-shaped.

28. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion tool including an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said sleeve is comprised of a super-elastic material.

29. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion tool including an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said sleeve is oval in cross-sectional shape.

30. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said insertion guide is removable after the sleeve is implanted between the spinous process.

31. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said guide is substantially cone-shaped.

32. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said sleeve is comprised of a super-elastic material.

33. An implant system for relieving pain associated with at least one of the spine, and associated tissues and structures, which implant is positionable between adjacent spinous processes of the spine, the implant system comprising:

a sleeve;

an insertion guide;

wherein said insertion guide extends from said sleeve preparatory to said guide and sleeve being positioned between two adjacent spinous processes; and

said sleeve is oval in cross-sectional shape.