Systems and methods for posterior dynamic stabilization of the spine

• US 8,317,864 B2
• Filed: 02/04/2005
• Issued: 11/27/2012
• 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: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Kim, Daniel H.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US11/052,002
• Publication Number:
  US 20060085069A1
• Time in Patent Office: 2,853 Days
• Field of Search: 623/17.12, 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 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; 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 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• 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 an expandable spacer or member having an unexpanded configuration and an expanded configuration, wherein the expandable member in an expanded configuration has a size, volume and/or shape configured for positioning between the spinous processes of adjacent vertebrae in order to distract the vertebrae relative to each other. The systems include one or more expandable members and a mechanical actuation means for expanding the expandable member. The methods involve the implantation of one or more devices or expandable spacers.

Claims

1. An interspinous device for stabilizing at least one spinal motion segment comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the device comprising:

an expandable member having a cross-sectional dimension and an enclosed volume configured to retain a fluid, the expandable member being deployable from a first configuration to a second configuration, wherein the cross-sectional dimension of the expandable member is different in the first configuration than in the second configuration, wherein the expandable member includes apexes configured to fold proximally of a distal end;

wherein, in the first configuration, the expandable member has a low profile configuration; and

wherein, in the second configuration, the expandable member has (a) a central portion with a first dimension configured to extend between the first and second spinous processes such that the central portion bears against the first and second spinous processes, and (b) lateral ends with a second dimension greater than the first dimension such that the lateral ends are configured to seat the first and second spinous processes at the central portion and configured to extend vertically along and contact opposing lateral sides of the first spinous process and to extend vertically along and contact opposing lateral sides of the second spinous process.

2. The device of claim 1 wherein the cross-sectional dimension of the expandable member in the first configuration is less than the cross-sectional dimension of the expandable member in the second configuration.

3. The device of claim 1 wherein the expandable member has an H-shape in the second configuration relative to a height dimension of a medial-lateral plane of the expandable member.

4. The device of claim 1, wherein a luminal surface of the expandable member is contoured.

5. The device of claim 1 wherein the expandable member comprises a non-compliant material that has a fixed volume in the second configuration.

6. The device of claim 1 wherein the lateral ends of the expandable member comprise a first lateral portion and a second lateral portion, and wherein the central portion is recessed relative to the first and second lateral portions such that the central portion is narrower than the first and second lateral portions along a height dimension of the expandable member to seat the first and second spinous processes.

7. The device of claim 6, further comprising an expansion medium, and wherein the expansion medium comprises a liquid.

8. The device of claim 1 wherein the expandable member is configured to pass between the first and the second spinous processes in the first configuration.

9. The device of claim 8 wherein the low profile configuration is defined by the cross-sectional dimension of the expandable member in the first configuration being less than the cross-sectional dimension of the expandable member in the second configuration.

10. The device of claim 1 wherein the low profile configuration is defined by the cross-sectional dimension of the expandable member in the first configuration being less than the cross-sectional dimension of the expandable member in the second configuration.

11. The device of claim 1 wherein the expandable member is expandable from the first configuration to the second configuration by the fluid.

12. The device of claim 11 wherein the first configuration is a low profile configuration to pass between the first and the second spinous processes, wherein the low profile configuration is defined by the cross-sectional dimension of the expandable member in the first configuration being less than the cross-sectional dimension of the expandable member in the second configuration.

13. The device of claim 1 wherein the low profile configuration is a narrow, elongated shape.

14. The device of claim 1 wherein the first configuration is configured to be translated through a delivery cannula.

15. The device of claim 1 wherein the expandable member in the first configuration is a tubular shaped member.

16. The device of claim 15 wherein the expandable tubular shaped member has a central portion and end portions, wherein the central portion and the end portions are of substantially similar cross-sectional diameter.

17. The device of claim 1 wherein the central portion and the lateral ends are tubular shaped in the first configuration.

18. The device of claim 17 wherein the central portion and the lateral ends are of substantially similar cross-sectional diameter in the first configuration.

19. The device of claim 1 wherein the expandable member is configured for delivery in a minimally invasive manner.

20. The device of claim 1 further comprising a tab configured to anchor the expandable member to a spinous process.

21. An interspinous device for stabilizing a spinal motion comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the interspinous device comprising:

a spacer configured to be positioned between the first spinous process and the second spinous process and expand from an undeployed configuration to a deployed configuration, wherein a cross-sectional dimension of the spacer is less in the undeployed configuration than in the deployed configuration, the spacer comprising—

an enclosed volume configured to retain a fluid;

a central portion that bears against the first and second spinous processes when the spacer is in the deployed configuration; and

lateral end portions on opposing sides of the central portion, wherein the lateral end portions include a pair of first elongated portions configured to extend vertically along and contact opposing sides of the first spinous process and a pair of second elongated portions configured to extend vertically along and contact opposing sides of the second spinous process to hold the first and second spinous processes at the central portion when the spacer is in the deployed configuration.

22. An interspinous device for stabilizing a spinal motion comprising a first spinous process of a first vertebra adjacent to a second spinous process of a second vertebra, the interspinous device comprising:

a spacer configured to at least partially distract the first spinous process from the second spinous process, wherein the spacer comprises—

a body defining an enclosed volume configured to retain a fluid, the body having a central portion positioned between first and second lateral end portions, the body being expandable from an undeployed state to a deployed state, wherein—

in the undeployed state the spacer has a low profile cross-sectional dimension for insertion between the first spinous process and the second spinous process; and

in the deployed state the spacer has an enlarged cross-sectional dimension for at least partially distracting the first spinous process and the second spinous process, and wherein the central portion bears against the first and second spinous processes and the first and second lateral end portions contact opposing lateral sides of the first and the second spinous processes to hold the first and second spinous processes at the central portion.

23. An interspinous device for stabilizing at least one spinous motion segment comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the device comprising:

an expandable member having a cross-sectional dimension and an enclosed volume configured to retain a fluid, the expandable member being deployable from a first configuration to a second configuration, wherein the cross-sectional dimension of the expandable member is different in the first configuration than in the second configuration, wherein the expandable member includes apexes configured to fold proximally of a distal end, wherein the expandable member comprises

a first tab coupled to one of the apexes,

a first tether coupled to the first tab,

a second tab coupled to another one of the apexes, and

a second tether coupled to the second tab;

wherein, in the first configuration, the expandable member has a low profile configuration; and

wherein, in the second configuration, the expandable member has (a) a central portion with a first dimension configured to extend between the first and second spinous processes such that the central portion bears against the first and second spinous processes, and (b) lateral ends with a second dimension greater than the first dimension such that the lateral ends are configured to seat the first and second spinous processes at the central portion.

24. The device of claim 23 wherein the first tab is configured to anchor the expandable member to the first spinous process, and the second tab is configured to anchor the expandable member to the second spinous process.

25. The device of claim 23 wherein the first tab and the second tab are positioned on opposite sides of the expandable member.

26. The device of claim 23 wherein the first tab is made of rubber.

27. The device of claim 23 wherein the first tab is made of metal.