Spine distraction implant and method

• US 6,238,397 B1
• Filed: 12/28/1999
• Issued: 05/29/2001
• Est. Priority Date: 01/02/1997
• Status: Expired due to Term

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: St Francis Technologies Incorporated
• Inventors: Klyce, Henry A., Zucherman, James F., Fallin, T. Wade, Hsu, Ken Y.
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/473,184
• Time in Patent Office: 518 Days
• Field of Search: 606/61, 606/105, 623/17.11, 623/17.16, 128/898
• US Class Current: 606/279
• 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. A method of relieving pain associated with at least one of the spinal column and associated tissues and structures including the steps of:

accessing adjacent first and second spinous processes of the spinal column;

distracting, without altering, the first and second spinous processes a sufficient amount in order to increase the volume of the spinal canal and/or the neural foramen in the spinal column in order to relieve pain; and

implanting between, without altering, the spinous processes, and from the sides of the spinous processes, a device in order to maintain the amount of distraction required to relieve the pain.

2. The method of claim 1 including the step of:

distracting apart the first and the second spinous process at least about 5 mm.

3. The method of claim 1 including the step of:

distracting apart the first and the second spinous process from about 5 mm to about 15 mm.

4. The method of claim 1 wherein:

said distracting step and said implanting step occur simultaneously as the step of implanting a device causes distraction.

5. The method of claim 1 wherein:

said device includes a distraction wedge; and

said distracting step and said implanting step occur simultaneously as the step of implanting a device causes distraction due to the distraction wedge distracting apart the first and the second spinous process.

6. The method of claim 1 including the step of:

maintaining intact the superspinous ligament.

7. The method of claim 1 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from the first sides of the spinous processes.

8. The method of claim 1 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from both the first sides of the spinous process and from the second sides of the spinous processes.

9. A method of relieving pain associated with at least one of the spinal column and associated tissues and structures including the steps of:

accessing adjacent first and second spinous processes of the spinal column; and

implanting a device from the sides of the spinous processes in order to distract apart, without altering, the first and second spinous processes a sufficient amount in order to increase the volume of the spinal canal and/or neural foramen in the spinal column to relieve pain, and in order to maintain the amount of distraction required to relieve the pain.

10. The method of claim 9 including the step of:

maintaining intact the superspinous ligament.

11. The method of claim 9 for relieving pain caused by at least one of spinal stenosis and facet arthropathy.

12. The method of claim 9 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from the first sides of the spinous processes.

13. The method of claim 9 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from both the first sides of the spinous process and from the second sides of the spinous processes.

14. A method of relieving pain associated with at least one of the spinal column and associated tissues and structures including the steps of:

accessing first sides and second sides of adjacent first and second spinous processes of the spinal column with an incision;

distracting, without altering, the first and second spinous processes a sufficient amount in order to increase the volume of the spinal canal and/or neural foramen in the spinal column in order to relieve pain; and

implanting between, without altering, the spinous process a first portion of a device through said incision adjacent first sides of the spinous processes and implanting a second portion of said device through said incision adjacent the second sides of the spinous processes, until said portions can be mated;

said device including a fastener, with the fastener used in a step of securing the first portion to the second portion in the mated configuration in order to maintain the amount of distraction required to relieve pain.

15. The method of claim 14 wherein:

the distracting step includes wedging the first and second spinous processes apart.

16. The method of claim 14 wherein:

said distracting step and said implanting step occur substantially simultaneously.

17. A method of relieving pain associated with at least one of the spinal column and associated tissues and structures including the steps of:

accessing first and second sides of adjacent first and second spinous processes of the spinal column with an incision;

implanting a first portion of a device through said incision adjacent first sides of the spinous process and a second portion of said device through said incision adjacent second sides of the spinous process, until said devices can be mated, and simultaneously distracting, without altering, the first and second spinous processes a sufficient amount in order to increase the volume of the spinal canal and/or neural foramen in the spinal column in order to relieve pain; and

said device including a fastener, with the fastener used in a step of securing the first portion to the second portion in the mated configuration in order to maintain the amount of distraction required to relieve the pain.

18. A method for relieving pain associated with at least one of the spinal column and associated tissues and structures including the steps of:

accessing first and second spinous processes from the sides of the spinous processes;

distracting, without altering, the first and second spinous processes in order to increase the volume of a spinal cord and/or neural foramen in the spinal column; and

implanting a device between, without altering, the first and second spinous processes to do one of (1) further distracting and maintaining the distraction of the first and second spinous processes, and (2) maintaining the distraction of the first and second spinous processes.

19. The method of claim 18 wherein the distracting step includes:

multiple distracting steps with a time period between distracting steps in order to allow the tissues associated with the spine to creep.

20. The method of claim 18 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from the first sides of the spinous processes.

21. The method of 18 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from both the first sides of the spinous process and from the second sides of the spinous processes.

22. A method for relieving pain associated with at least one of the spinal column and associated tissues and structures including the steps of:

accessing first and second spinous processes from sides of the spinous processes;

implanting a device in order to distract, without altering, the first and second spinous processes to increase the volume of a spinal canal and/or neural foramen in the spinal column; and

maintaining the distraction with the device, without altering, the first and second spinous processes.

23. The method of claim 22 wherein the implanting step includes:

multiple distracting steps with a time period between distracting steps in order to allow the tissues associated with the spine to creep.

24. The method of claim 22 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from the first sides of the spinous processes.

25. The method of claim 22 wherein:

said spinous processes each have a first side and a second side and the implanting step includes implanting from both the first sides of the spinous process and from the second sides of the spinous processes.

26. A method of relieving pain associated with at least one of the spine and surrounding structure and tissue including the steps of:

accessing adjacent first and second spinous processes of the spine;

distracting, without altering, the first and second spinous processes a sufficient amount in order to relieve pain; and

implanting between, without altering, the spinous process and from the sides of the spinous processes, a device in order to maintain the amount of distraction required to relieve the pain.

27. A method of relieving pain associated with at least one of the spine and surrounding structure and tissue including the steps of:

accessing adjacent first and second spinous processes of the spine; and

implanting a device from the sides of the spinous processes in order to distract apart, without altering, the first and second spinous processes a sufficient amount to relieve pain and in order to maintain the amount of distraction required to relieve the pain.

28. A method of relieving pain associated with at least one of the spine and surrounding structure and tissue, including the steps of:

accessing first sides and second sides of adjacent first and second spinous processes of the spine with an incision;

distracting, without altering, the first and second spinous processes a sufficient amount in order to relieve pain;

implanting between, without altering, the spinous process a first portion of a device through said incision adjacent first sides of the spinous processes and a second portion of said device through said incision adjacent second sides of the spinous processes, until said devices can be mated; and

said device including a fastener, with the fastener used in a step of securing the first portion to the second portion in the mated configuration in order to maintain the amount of distraction required to relieve the pain.

29. The method of claim 28 including:

using a tool having a first arm on to which is mounted the first portion of the device and a second arm on to which is mounted the second portion of the device in order to urge the first portion and the second portion through the incision and into the mating position.

30. A method for relieving pain associated with at least one of the spine and surrounding structure and tissue, including the steps of:

accessing first and second spinous processes from sides of the first and second spinous processes;

distracting, without altering, the first and second spinous processes from sides of the first and second spinous processes; and

implanting a device between, without altering, the first and second spinous processes to do one of (1) further distracting and maintaining the distraction of the first and second spinous processes, and (2) maintaining the distraction of the first and second spinous processes.

31. The method of claim 30 wherein:

the distracting step and the implanting step occurs substantially simultaneously.

32. A method for relieving pain associated with at least one of the spine and surrounding structure and tissue, including the steps of:

accessing first and second spinous processes from the sides of the first and second spinous processes;

implanting a device from the sides of the first and second spinous processes in order to distract, without altering, the first and second spinous processes to increase the volume of a spinal canal and/or neural foramen in the spine; and

maintaining the distraction with the device, without altering, the first and second spinous processes.

33. A method of relieving pain associated with at least one of the spine and associated tissues and structures including the steps of:

accessing a first spinous process and an adjacent bony structure of the spine;

distracting, without altering, the first spinous processes and the adjacent bony structure of the spine a sufficient amount in order to increase the volume of the spinal canal and/or the neural foramen in the spine in order to relieve pain; and

implanting between, without altering, the spinous process and the adjacent bony structure of the spine, and from the sides of the spinous process and the adjacent bony structure, a device in order to maintain the amount of distraction required to relieve pain.

34. A method of relieving pain associated with at least one of the spine and associated tissues and structures including the steps of:

accessing a first spinous process and an adjacent bony structure of the spine; and

implanting a device from the sides of the spinous process and the adjacent bony structure in order to distract apart, without altering, the first spinous process and the adjacent bony structure a sufficient amount in order to increase the volume of the spinal canal and/or neural foramen in the spine to relieve pain and in order to maintain the amount of distraction required to relieve pain.