Spine distraction implant

• US 6,190,387 B1
• Filed: 12/28/1999
• Issued: 02/20/2001
• 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): Buiz, Michael
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/474,037
• Time in Patent Office: 420 Days
• Field of Search: 606/53, 606/60, 606/61, 606/76, 606/78, 606/105, 623/17-1-
• 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 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 for relieving pain associated with at least one of the spine and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spine, 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, wherein said securing means is the only means for adjusting the spacing between the first wing and the second wing.

2. The implant of claim 1 wherein:

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

3. The implant of claim 1 whereas:

said securing means includes a plurality of ports in the central body through which the second wing can be selectively positioned and secured to the central body.

4. The implant of claim 1 whereas:

said securing means includes a plurality of ports by which the second wing can be selectively positioned and secured to the central body.

5. An implant for relieving pain associated with at least one of the spine and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spine, 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 which said device is the only device that secures the second wing to the first unit.

6. The implant of claim 5 wherein:

said sleeve is oval in cross-sectional shape.

7. The implant of claim 5 wherein:

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

8. The implant of claim 7 wherein:

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

9. The implant of claim 5 wherein:

said sleeve is comprised of a super-elastic material.

10. The implant of claim 5 wherein:

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

11. The implant of claim 5 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.

12. The implant of claim 5 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.

13. The implant of claim 5 wherein:

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

14. The implant of claim 5 wherein:

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

15. The implant of claim 5 wherein:

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

16. The implant of claim 5 wherein:

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.

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

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

a second wing;

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; and

said securing means includes a plurality of ports in the central body through which the second wing can be selectively positioned and secured to the central body.

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

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

a second wing;

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; and

said securing means includes a plurality of ports by which the second wing can be selectively positioned and secured to the central body.

19. An implant for relieving pain associated with at least one of the spine and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spine, 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, wherein said sleeve is free to rotate relative to the central body.

20. An implant for relieving pain associated with at least one of the spine and surrounding tissues and structures, which implant is positionable between adjacent spinous processes of the spine, 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, wherein said sleeve is a separate piece from the first unit and the second wing.

21. The implant of claim 20 wherein:

said sleeve is oval in cross-sectional shape.

22. The implant of claim 20 wherein:

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

23. The implant of claim 22 wherein:

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

24. The implant of claim 20 wherein:

said sleeve is comprised of a super-elastic material.

25. The implant of claim 20 wherein:

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

26. The implant of claim 20 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.

27. The implant of claim 20 wherein:

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

28. The implant of claim 20 wherein:

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.