Systems and methods for posterior dynamic stabilization of the spine

• US 8,012,207 B2
• Filed: 03/10/2005
• Issued: 09/06/2011
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Kim, Daniel H.
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): Prone; Christopher D
• Application Number:
  US11/079,006
• Publication Number:
  US 20060084988A1
• Time in Patent Office: 2,371 Days
• Field of Search: 623/17.11, 623/17.16
• US Class Current: 623/17.11
• 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 2017/00557 inflatable A61B2017/22051 takes precedence

Abstract

Devices, systems and methods for dynamically stabilizing the spine are provided. The devices include a radially expandable spacer having an undeployed configuration and a deployed configuration, wherein the spacer has axial and radial dimensions for positioning between the spinous processes of adjacent vertebrae. The systems include one or more spacers and a mechanical actuation means for delivering and deploying the spacer. The methods involve the implantation of one or more spacers within the interspinous space.

Claims

1. A method for stabilizing a superior vertebra having a superior spinous process relative to an inferior vertebra having an inferior spinous process, wherein the superior and inferior spinous processes define an interspinous space, the method comprising:

inserting an interspinous device into the interspinous space by moving the interspinous device anteriorly substantially along a midline relative to the superior and inferior spinous processes through an incision located posterior of the interspinous space;

moving a superior strut unit of the interspinous device by radial expansion to extend superiorly such that the superior spinous process is seated between first and second superior struts of the superior strut unit, wherein the superior strut unit is moved after implanting the interspinous device; and

moving an inferior strut unit of the interspinous device by radial expansion to extend inferiorly such that the inferior spinous process is seated between first and second inferior struts of the inferior strut unit, wherein the inferior strut unit is moved after implanting the interspinous device.

2. The method of claim 1, wherein the interspinous device has an anterior-posterior axis and the superior and inferior struts extend along the anterior-posterior axis while inserting the interspinous device into the interspinous space.

3. The method of claim 2 wherein moving the superior and inferior strut units comprises extending the first and second superior struts and the first and second inferior struts away from the anterior-posterior axis.

4. The method of claim 3 wherein the interspinous device has a tool interface facing posteriorly and the method comprises engaging a delivery tool with the tool interface before inserting the interspinous device into the interspinous space, and wherein extending the first and second superior struts and the first and second inferior struts comprises manipulating the delivery tool while the delivery tool extends posteriorly relative to the first and second vertebrae through the incision posterior of the interspinous space.

5. The method of claim 4 wherein the first and second superior struts and the first and second inferior struts are extended simultaneously.

6. The method of claim 2 wherein the first and second superior struts and the first and second inferior struts are rotated away from the anterior-posterior axis simultaneously.

7. The method of claim 4 wherein, while the delivery tool extends through the incision, the delivery tool has a shaft extending substantially perpendicular to a plane that is substantially perpendicular to the anterior-posterior axis.

8. The method of claim 1 wherein moving the first strut unit and moving the second strut unit comprises rotating the first and second strut units such that the first and second superior struts and the first and second inferior struts are in a transverse plane at least substantially perpendicular to the anterior-posterior axis after extension.

9. The method of claim 8 wherein the superior strut unit and the inferior strut unit together define an X-shaped configuration in the transverse plane after deployment.

10. The method of claim 8 wherein the superior strut unit and the inferior strut unit together define an H-shaped configuration in the transverse plane after deployment.

11. The method of claim 1, further comprising forming the incision at the midline posterior of the interspinous space and inserting the device comprises passing the device through the midline incision.

12. A method for stabilizing a superior vertebra having a superior spinous process relative to an inferior vertebra having an inferior spinous process, comprising:

creating an incision at a midline located posterior of the interspinous space;

inserting an interspinous device into the interspinous space by moving the interspinous device anteriorly relative to the incision; and

changing the interspinous device from an undeployed configuration to a deployed configuration by radial expansion, wherein the interspinous device includes a pair of inferior struts and a pair of superior struts which are configured to have a low profile in the undeployed configuration relative to the deployed configuration, and wherein the inferior struts of the interspinous device are configured to seat the inferior spinous processes in the deployed configuration and the superior struts of the interspinous device are configured to seat the superior spinous processes in the deployed configuration, and thereby relieve pain.

13. The method of claim 12, wherein the interspinous device has an anterior-posterior axis and the superior and inferior struts extend along the anterior-posterior axis while inserting the interspinous device into the interspinous space.

14. The method of claim 13 wherein the interspinous device has a tool interface facing posteriorly and the method comprises engaging a delivery tool with the tool interface before inserting the interspinous device into the interspinous space, and wherein extending the first and second superior struts and the first and second inferior struts comprises manipulating the delivery tool while the delivery tool extends posteriorly relative to the first and second vertebrae through the incision posterior of the interspinous space.

15. The method of claim 12 wherein moving the superior and inferior strut pairs comprises extending the first and second superior struts and the first and second inferior struts away from the anterior-posterior axis.

16. The method of claim 15 wherein the first and second superior struts and the first and second inferior struts are extended simultaneously.

17. The method of claim 15 wherein, while the delivery tool extends through the incision, the delivery tool has a shaft extending substantially perpendicular to a plane that is substantially perpendicular to the anterior-posterior axis.

18. The method of claim 12 wherein the first and second superior struts and the first and second inferior struts are rotated away from the anterior-posterior axis simultaneously.

19. The method of claim 12 wherein moving the inferior strut pair and moving the superior strut pair comprises rotating the inferior and superior strut pair such that the first and second superior struts and the first and second inferior struts are in a transverse plane at least substantially perpendicular to the anterior-posterior axis after extension.

20. The method of claim 19 wherein the superior strut pair and the inferior strut pair together define an X-shaped configuration in the transverse plane after deployment.

21. The method of claim 19 wherein the superior strut unit and the inferior strut unit together define an H-shaped configuration in the transverse plane after deployment.

22. The method of claim 12, further comprising forming the incision at the midline posterior of the interspinous space and inserting the device comprises passing the device through the midline incision.