Spine distraction implant and method

• US 6,090,112 A
• Filed: 07/28/1998
• Issued: 07/18/2000
• 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., Fallin, T. Wade, Hsu, Ken Y.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/124,203
• Time in Patent Office: 721 Days
• Field of Search: 606/60, 606/61, 623/17
• US Class Current: 606/249
• 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 17/7065 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 2017/0256 for the spine
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen

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 the spine and related structures and tissues comprising:

a device that is adapted to be positionable between a first spinous process and a second spinous process;

said device including a first means for not limiting flexion of the spine;

said device including a second means for limiting extension of the spine;

said device includes a means for distracting the first spinous process from the second spinous process;

wherein said first means and said second means are defined by a first member and a second member, with the first member mated to the second member;

wherein said first member has a central body extending therefrom, which central body is adapted for being positioned between the first spinous process and the second spinous process; and

wherein said distracting means includes a rounded nose lead-in plug which extends from the central body of the first member in order to guide the central body of the first member between the first spinous process and the second process, said distracting means for additionally positioning the first member so that the first member can be mated with the second member at about the location where the rounded nose lead-in plug extends from the central body, and the distracting means is sized in order to distract, without altering, the first spinous process and the second spinous process.

2. The implant of claim 1 wherein:

said distracting means is generally pyramid shaped.

3. The implant of claim 1 wherein:

said distracting means is generally cone shaped.

4. The implant of claim 1 wherein:

said central body is cylindrical in shape.

5. The implant of claim 1 wherein:

said central body is cylindrical in shape and has a cross-section across a longitudinal axis, which cross-section has a major dimension and a minor dimension, and

wherein said major dimension is one of (1) about the same as said minor dimension, and (2) larger than said minor dimension and said minor dimension is adapted to be provided along an axis which extends through the first spinous process and the second spinous process.

6. The implant of claim 5 wherein:

said central body includes first and second flats between which said minor dimension is defined.

7. The implant of claim 1 wherein:

said central body is cylindrical in shape and has flats which are adapted to carry and spread the load applied thereto by the first and the second spinous processes.

8. The implant of claim 1 wherein:

said central body is cylindrical in shape and has flats which are adapted to be placed adjacent the respective first and second spinous processes.

9. The implant of claim 1 wherein:

said first member defines a first wing which is adapted to be positioned adjacent to first sides of the first and second processes and the second member defines a second wing which is adapted to be positioned adjacent to second sides of the first and second spinous processes which are opposite to the first sides.

10. The implant of claim 1 wherein:

said central body is cylindrical in shape and has a cross-section across a longitudinal axis, which cross-section has a major dimension and a minor dimension, and

wherein said major dimension is larger than said minor dimension and said minor dimension is adapted to be provided along an axis which extends through the first spinous process and the second spinous process.

11. A spinal column implant comprising:

a device that is adapted to be positionable between a first spinous process and a second spinous process;

said device includes a spinal column extension stop;

said device includes a spinal column flexion non-inhibitor;

wherein said spinal column extension stop and the spinal column flexion non-inhibitor are defined by a first member and a second member, with the first member mated to the second member;

wherein said first member has a central body extending therefrom, which central body is adapted for being positioned between the first spinous process and the second spinous process; and

wherein said implant includes a rounded nose lead-in plug which extends from the central body of the first member in order to guide the central body of the first member between the first spinous process and the second process in order to position the first member so that the first member can be mated with the second member at about the location where the rounded nose lead-in plug extends from the central body, and the lead-in plug is sized in order to distract, without altering, the first spinous process and the second spinous process.

12. The implant of claim 11 wherein:

said lead-in plug is generally pyramid shaped.

13. The implant of claim 11 wherein:

said lead-in plug is generally conical in shape.

14. The implant of claim 11 wherein:

said central body is cylindrical in shape and has a cross-section across a longitudinal axis, which cross-section has a major dimension and a minor dimension, and

wherein said major dimension is one of (1) about the same as said minor dimension, and (2) larger than said minor dimension and said minor dimension is adapted to be provided along an axis which extends through the first spinous process and the second spinous process.

15. The implant of claim 11 wherein:

said central body is cylindrical in shape and has flats which are adapted to carry and spread the load applied thereto by the first and the second spinous processes.

16. The implant of claim 11 wherein:

said central body is cylindrical in shape and has flats which are adapted to be placed adjacent the respective first and second spinous processes.

17. The implant of claim 16 wherein:

said central body includes first and second flats between which said minor dimension is defined.

18. The implant of claim 11 wherein:

said first member defines a first wing which is adapted to be positioned adjacent to first sides of the first and second processes and the second member defines a second wing which is adapted to be positioned adjacent to second sides of the first and second spinous processes which are opposite to the first sides.

19. The implant of claim 11 wherein:

said central body is cylindrical in shape and has a cross-section across a longitudinal axis, which cross-section has a major dimension and a minor dimension, and

wherein said major dimension is larger than said minor dimension and said minor dimension is adapted to be provided along an axis which extends through the first spinous process and the second spinous process.

20. An implant for relieving pain associated with the spine and related structures and tissues comprising:

a device that is adapted to be positionable between a first spinous process and a second spinous process;

said device including a first means for limiting extension of the spine;

said device includes a means for distracting the first spinous process from the second spinous process;

wherein said first means is defined by a first member and a second member, with the first member mated to the second member;

wherein said first member has a central body extending therefrom, which central body is adapted for being positioned between the first spinous process and the second spinous process; and

wherein said distracting means includes a rounded nose lead-in plug which extends from the central body of the first member in order to guide the central body of the first member between the first spinous process and the second process, said distracting means for additionally positioning the first member so that the first member can be mated with the second member at about the location where the rounded nose lead-in plug extends from the central body, and the distracting means is sized in order to distract, without altering, the first spinous process and the second spinous process.

21. The implant of claim 20 wherein:

said central body is cylindrical in shape and has a cross-section across a longitudinal axis, which cross-section has a major dimension and a minor dimension, and

wherein said major dimension is larger than said minor dimension and said minor dimension is adapted to be provided along an axis which extends through the first spinous process and the second spinous process.

22. An implant for relieving pain associated with the spine and related structures and tissues comprising:

a device that is adapted to be positionable between a first spinous process and a second spinous process;

said device including a first means for not limiting flexion of the spine;

said device including a second means for limiting extension of the spine;

said device includes a means for distracting the first spinous process from the second spinous process;

wherein said first means and said second means are defined by a first member and a second member, with the first member mated to the second member;

wherein said first member has a central body extending therefrom, which central body is adapted for being positioned between the first spinous process and the second spinous process, and wherein said central body does not have any apertures for allowing the in-growth of bone; and

wherein said distracting means includes a rounded nose lead-in plug which extends from the central body of the first member in order to guide the central body of the first member between the first spinous process and the second process, said distracting means for additionally positioning the first member so that the first member can be mated with the second member at about the location where the rounded nose lead-in plug extends from the central body, and the distracting means is sized in order to distract, without altering, the first spinous process and the second spinous process.

23. A spinal column implant comprising:

a device that is adapted to be positionable between a first spinous process and a second spinous process;

said device includes a spinal column extension stop;

said device includes a spinal column flexion non-inhibitor;

wherein said spinal column extension stop and the spinal column flexion non-inhibitor are defined by a first member and a second member, with the first member mated to the second member;

wherein said first member has a central body extending therefrom, which central body is adapted for being positioned between the first spinous process and the second spinous process, and wherein said central body does not have any apertures for allowing the in-growth of bone; and

wherein said implant includes a rounded nose lead-in plug which extends from the central body of the first member in order to guide the central body of the first member between the first spinous process and the second process in order to position the first member so that the first member can be mated with the second member at about the location where the rounded nose lead-in plug extends from the central body, and the lead-in plug is sized in order to distract, without altering, the first spinous process and the second spinous process.

24. An implant for relieving pain associated with the spine and related structures and tissues comprising:

a device that is adapted to be positionable between a first spinous process and a second spinous process;

said device including a first means for limiting extension of the spine;

said device includes a means for distracting the first spinous process from the second spinous process;

wherein said first means is defined by a first member and a second member, with the first member mated to the second member;

wherein said first member has a central body extending therefrom, which central body is adapted for being positioned between the first spinous process and the second spinous process, and wherein said central body does not have any apertures for allowing the in-growth of bone; and

wherein said distracting means includes a rounded nose lead-in plug which extends from the central body of the first member in order to guide the central body of the first member between the first spinous process and the second process, said distracting means for additionally positioning the first member so that the first member can be mated with the second member, and the distracting means is sized in order to distract, without altering, the first spinous process and the second spinous process.