Systems and methods for posterior dynamic stabilization of the spine

• US 9,314,279 B2
• Filed: 10/23/2012
• Issued: 04/19/2016
• 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): Prone, Christopher D
• Application Number:
  US13/658,756
• Publication Number:
  US 20130289622A1
• Time in Patent Office: 1,274 Days
• Field of Search: 623/17.11, 606247-249, 606/279
• US Class Current: 1/1
• 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:

a member having a length and a diameter and being deployable from a first configuration to a second configuration, wherein one of the length and the diameter of the member in the first configuration is changed when the member is in the second configuration, and wherein the member includes a central section,

first and second end portions spaced apart to receive the first and second spinous processes therebetween, wherein the first and second end portions are configured to move along opposite sides of the first spinous process and to move along opposite sides of the second spinous process when the central section is positioned directly between the first and second spinous processes and the member moves from the first configuration to the second configuration, and

wherein the central section is configured to be positioned between the first and second end portions such that the first and second end portions extend away from the central section when the member is in the second configuration, and wherein the central section is configured to contact and gradually push apart the first and second spinous processes when the member moves toward the second configuration for distracting the first and second spinous processes and when the central section extends transversely across the first and second spinous processes.

2. The device of claim 1 wherein the length of the member in the first configuration is greater than the length of the member in the second configuration.

3. The device of claim 1 wherein the diameter of the member in the second configuration is greater than the diameter of the member in the first configuration.

4. The device of claim 1, further comprising

a core member positionable within the member;

and

first and second hubs configured for coupling with a first end of the core member and a second end of the core member, respectively.

5. The device of claim 4, wherein the at least one of the hubs is configured to translate axially over the core member.

6. The device of claim 1, wherein the member comprises a polymer material.

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

8. The device of claim 1, wherein the central section includes a first portion and a second portion that move away from each other when the member moves toward the second configuration, wherein the first and second portions of the central section are configured to extend transversely across and contact the first and second spinous processes, respectively, when the member is in the first configuration.

9. The device of claim 1 wherein the first and second end portions are configured to move simultaneously along opposite sides of the first and second spinous processes.

10. The device of claim 1 wherein a diameter of the member at the central section increases by about 200% when the member moves from the first configuration toward the second configuration.

11. The device of claim 10 wherein the diameter of the member increases by about 400% when the member moves from the first configuration to the second configuration.

12. A system 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 system comprising:

the interspinous device of claim 1; and

a delivery device for delivering the interspinous device when in the first configuration between the first and second spinous process and for deploying the interspinous device in the second configuration.

13. The system of claim 12 wherein the delivery device comprises:

an elongated shaft having a detachable distal end configured for insertion into the member of the interspinous device; and

a handle mechanism for moving the elongated shaft wherein the movement causes the member to be deployed from the first configuration to the second configuration.

14. 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 interspinous device comprising:

a member having a length and a diameter and being deployable from a first configuration to a second configuration, wherein one of the length and the diameter of the member in the first configuration is changed when the member is in the second configuration, and wherein the member includes

first and second end portions spaced apart to receive the first and second spinous processes therebetween, wherein the first and second end portions are configured to move along opposite sides of the first spinous process and to move along opposite sides of the second spinous process when the member is positioned between the first and second spinous processes and moves from the first configuration to the second configuration,

a central section positioned between the first and second end portions such that the first and second end portions extend away from the central section when the member is in the second configuration, and wherein the central section is configured to contact and space apart the first and second spinous processes when the first and second spinous processes are located directly between the first and second end portions and when the member is in the second configuration such that the central section extends transversely across the first and second spinous processes, and

a retaining member circumferentially positioned about a portion of the length of the member, wherein a diameter of the retained portion of the member is less than the diameter of the unretained portion of the member when the member is in the second configuration.

15. The device of claim 14 wherein the diameter of the retained portion of the member in the second configuration is sufficient to distract the first and second vertebrae relative to each other when the device is operably implanted between the first and second spinous processes.

16. The device of claim 14, wherein the retaining member is positioned about the central section of the member.

17. The device of claim 14, wherein the retaining member comprises a braided or mesh material.

18. An interspinous device movable from an undeployed configuration to a deployed H-shaped configuration, the interspinous device comprising:

a first deployable portion configured to move superiorly along a first side of a superior spinous process of a subject and to move inferiorly along a first side of an inferior spinous process when the interspinous device is located between the superior and inferior spinous processes and moves toward the deployed H-shaped configuration;

a second deployable portion that moves superiorly along a second side of the superior spinous process and moves inferiorly along a second side of the inferior spinous process when the interspinous device is located between the superior and inferior spinous processes and moves toward the deployed H-shaped configuration; and

a central section between the first and second deployable portions, and wherein the central section is positioned to move into contact with and to extend laterally across the superior and inferior spinous processes when the superior and inferior spinous processes are located directly between the first and second deployable portions extending superiorly and inferiorly along the superior and inferior spinous processes, wherein the central section includes a superior portion and an inferior portion that move away from each other when the interspinous device is moved toward the deployed H-shaped configuration, and wherein the superior and inferior portions are configured to move away from each other and to contact the superior and inferior spinous processes, respectively, to push apart the superior and inferior spinous processes when the interspinous device is moved toward the deployed H-shaped configuration.

19. The interspinous device of claim 18, wherein the superior and inferior portions and the first and second deployable portions together define a H-shape when the interspinous device is in the deployed H-shaped configuration.

20. The interspinous device of claim 18, wherein the interspinous device in the undeployed configuration has a tubular shape.

21. The interspinous device of claim 18, wherein the interspinous device has a longitudinal axis, and wherein the interspinous device is configured such that the longitudinal axis is substantially perpendicular to a sagittal plane of the subject when the interspinous device spaces apart the inferior and superior spinous processes.

22. The interspinous device of claim 18, wherein the superior and inferior portions extend laterally across the superior and inferior spinous processes when the interspinous device is in the deployed configuration and is located between the superior and inferior spinous processes.

23. An interspinous device movable from an undeployed configuration to a deployed H-shaped configuration, the interspinous device comprising:

a first deployable portion configured to move superiorly along a first side of a superior spinous process of a subject and to move inferiorly along a first side of an inferior spinous process when the interspinous device is located between the superior and inferior spinous processes and moves toward the deployed H-shaped configuration;

a second deployable portion that moves superiorly along a second side of the superior spinous process and moves inferiorly along a second side of the inferior spinous process when the interspinous device is located between the superior and inferior spinous processes and moves toward the deployed H-shaped configuration; and

a central section between the first and second deployable portions, and wherein the central section is positioned to move into contact with and to extend laterally across the superior and inferior spinous processes when the superior and inferior spinous processes are located directly between the first and second deployable portions extending superiorly and inferiorly along the superior and inferior spinous processes, and wherein the central section expands in superior and inferior directions relative to the subject when the interspinous device is located between the superior and inferior spinous processes and the interspinous device is moved toward the deployed H-shaped configuration.

24. An interspinous device movable from an undeployed configuration to a deployed H-shaped configuration, the interspinous device comprising:

a superior U-shaped portion configured to receive a superior spinous process when the interspinous device is in the deployed H-shaped configuration, the superior U-shaped portion including deployable superior portions and a superior central section between the deployable superior portions; and

an inferior U-shaped portion configured to receive an inferior spinous process when the interspinous device is in the deployed H-shaped configuration, the inferior U-shaped portion including deployable inferior portions and an inferior central section between the deployable inferior portions,

wherein the superior and inferior central sections move away from one another and into contact with the superior and inferior spinous processes of a subject and to distract the superior and inferior spinous processes as the interspinous device moves toward the deployed configuration, and wherein a distance between regions of the superior and inferior central sections for contacting the respective superior and inferior spinous processes increase at least by about 200% when the interspinous device moves from the undeployed configuration to the deployed H-shaped configuration.

25. The interspinous device of claim 24, wherein the superior and inferior U-shaped portions are movable away from each other to bring the superior and inferior U-shaped portions into contact with the superior and inferior spinous processes.

26. The interspinous device of claim 24, wherein the deployable superior and inferior U-shaped portions are configured to move simultaneously along opposite sides of the respective superior and inferior spinous processes.

27. An interspinous device movable from an undeployed configuration to a deployed configuration, the interspinous device comprising:

a superior portion configured to be in a U-shaped configuration for retaining a superior spinous process when the interspinous device is in the deployed configuration, the superior portion including superior end portions and a superior central section between the superior end portions; and

an inferior portion configured to be in a U-shaped configuration for retaining an inferior spinous process when the interspinous device is in the deployed configuration, the inferior portion including inferior end portions and an inferior central section between the inferior end portions,

wherein the superior and inferior central sections move away from one another to increase a diameter of a member at the central section by 200% such that the superior and inferior central sections push apart the superior and inferior spinous processes as the interspinous device moves toward the deployed configuration to move the superior and inferior end portions along opposite sides of the superior and inferior spinous processes.

28. The interspinous device of claim 27, wherein the diameter of the member at the central section is increased by about 400% when the interspinous device moves from the undeployed configuration to the deployed configuration.

29. The interspinous device of claim 27, wherein the superior end portions move away from the superior central section and the inferior end portions move away from the inferior central section when the interspinous device moves toward the deployed configuration.

30. The interspinous device of claim 27, wherein the interspinous device is configured to be couple to and deployed by a delivery device such that the interspinous device controllably distracts the superior and inferior spinous processes based on operation of the delivery device.