Spine distraction implant and method

• US 6,074,390 A
• Filed: 02/05/1998
• Issued: 06/13/2000
• 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:
  US09/018,479
• Time in Patent Office: 859 Days
• Field of Search: 606/61, 606/105, 623/17
• US Class Current: 606/86.00A
• 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 due to the development of spinal stenosis in the spinal column including the steps of:

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

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 due to the development of spinal stenosis; and

implanting between, without altering, the spinous process a first portion of a device through said first incision and a second portion of said device through said second incision, 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 the pain due to spinal stenosis.

2. The method of claim 1 wherein:

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

3. A method of relieving pain due to the development of spinal stenosis in the spinal column including the steps of:

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

distracting 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 due to the development of spinal stenosis; and

implanting a first portion of a device through said first incision and a second portion of said device through said second incision, 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 the pain due to spinal stenosis; and

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 respective first and second incisions and into the mating position.

4. A method of relieving pain due to the development of spinal stenosis in the spinal column including the steps of:

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

implanting a first portion of a device through said first incision and a second portion of said device through said second incision, 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.

5. A method for relieving pain associated with the spinal column comprising the steps of:

implanting a device between and engaging a first spinous process and a second spinous process, said device including a first forked end and a second forked end, and said device including an interbody piece which is operably connected to the first and second forked ends so that rotation of the interbody piece causes the first and second forked ends to move apart in order to distract the first and the second spinous processes with respect to each other; and

distracting the spinous processes by rotating the interbody piece.

6. A method of relieving pain associated with the spine including the steps of:

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

positioning a Z-shaped implant between the spinous processes in order to either distract and maintain the distraction between the spinous processes and/or to maintain a distraction between the two spinous processes;

wherein said Z-shaped implant has first and second arms extending from a central body, and the positioning step includes guiding the first arm between a space between the first and second spinous processes until the central body is located between the spinous processes with the first arm on one side of the spinous processes and the second arm on the other side of the spinous processes.

7. The method of claim 6 including the steps of:

selecting arms that are contoured to the spine; and

positioning the arms adjacent to the portion of the spine for which they are contoured.

8. The method of claim 6 including the steps of:

selecting arms that are contoured to be positioned adjacent to one of L4-L5 and L5-S1 vertebrae; and

positioning the implant between the vertebrae for which the implant was contoured.

9. The method of claim 6 wherein said positioning step is for relieving pain due to the development of spinal stenosis.

10. A method of relieving pain associated with the spine including the steps of:

accessing adjacent first and second spinous processes of the spine;

implanting a first portion of a device and a second portion of the device adjacent to the first and second spinous processes, until said portions can be mated;

wherein the implanting step at least one of (1) distracts the first and second spinous processes, or (2) maintains the distraction between the first and second spinous processes;

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 distraction; and

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 into the mating position.

11. A method of relieving pain associated with the spine and surrounding structure and tissue, including the steps of:

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

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 first incision and a second portion of said device through said second incision, 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.

12. The method of claim 11 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 respective first and second incisions and into the mating position.

13. A method of relieving pain associated with the spine and surrounding structure and tissue, including the steps of:

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

implanting a first portion of a device through said first incision and a second portion of said device through said second incision, until said devices can be mated, and simultaneously distracting, without altering, the first and second spinous processes a sufficient amount 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.

14. An improved method for stabilizing a spinous process relative another spinous process, said method being of the type wherein a device having at least two pieces is implanted between the spinous process and other spinous process, wherein said improvement comprises:

introducing one piece through a first incision and separately introducing a second piece through a second incision.