Systems and methods for posterior dynamic stabilization of the spine

• US 9,125,692 B2
• Filed: 02/25/2013
• Issued: 09/08/2015
• 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:
  US13/776,611
• Publication Number:
  US 20130165974A1
• Time in Patent Office: 925 Days
• Field of Search: 623/17.11, 606247-249
• US Class Current: 1/1
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• 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
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment

Abstract

Devices, systems and methods for dynamically stabilizing the spine are provided. The devices include an 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 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 undeployed configuration having an axial dimension and a radial dimension substantially transverse to the axial dimension;

a deployed configuration having an axial dimension and a radial dimension substantially transverse to the axial dimension such that the device in the deployed configuration maintains spacing between the first and second spinous processes after the device is implanted;

wherein the radial dimension of the undeployed configuration is less than the radial dimension in the deployed configuration;

a first arm member configured to receive the first spinous process and including a first bridge portion;

a second arm member configured to receive the second spinous process and including a second bridge portion, wherein the first and second arm members are substantially parallel to a long axis of the device when the device is in the undeployed configuration and the long axis extends in an anterior-to-posterior direction relative to the spinal motion segment and when the first and second arm members are located at an interspinous space between the first and second spinous processes, wherein the first and second bridge portions are configured to extend transversely across the first and second spinous processes, respectively, when the first spinous process is located in a U-shape gap defined by the first arm member, the second spinous process is located in a U-shape gap defined by the second arm member, and the long axis of the device extends in the anterior-to-posterior direction relative to the spinal motion segment; and

a body configured to be releasably coupled to a delivery device such that the delivery device is capable of driving components of the body to cause rotation of the first and second arm members relative to the body such that the first and second bridge portions rotate away from the body and toward the first and second spinous processes, respectively, as the device moves from the undeployed configuration toward the deployed configuration when the axial dimension of the undeployed configuration extends in the anterior-to-posterior direction relative to the spinal motion segment.

2. The device of claim 1, wherein the axial dimension of the undeployed configuration is greater than the axial dimension in the deployed configuration.

3. The device of claim 1, wherein the radial dimension is defined at least in part by the first and second arm members.

4. The device of claim 3, wherein the first and second arm members comprise linkages.

5. The device of claim 3, wherein the first bridge portion extends between a first pair of radially expandable linkages of the first arm member and a second bridge portion extends between a second pair of radially expandable linkage of the second arm member.

6. The device of claim 1, wherein the device in the deployed configuration has a “

X”

shape.

7. 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 and an interspinous space defined between the first and second spinous processes, the system comprising:

the device of claim 1; and

a device for delivering the device in the undeployed configuration within the interspinous space and for radially expanding the device from the undeployed configuration to the deployed configuration.

8. The device of claim 1, wherein the first and second arm members are generally parallel to a longitudinal axis of the body when the device is in the undeployed configuration and are generally perpendicular to the direction of the longitudinal axis of the body when the device is in the deployed configuration.

9. The device of claim 1, wherein the first and second arm members comprise metal.

10. The device of claim 1, further comprising:

at least one first pin that rotatably couples the first arm member to the body; and

at least one second pin that rotatably couples the second arm member to the body.

11. A system for stabilizing a spinal motion segment comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the system comprising:

a spacer device having an undeployed configuration for delivery between the first and second spinous processes and a deployed configuration for stabilizing the spinal motion segment after implantation of the spacer device, the spacer device including—

a central body having a long axis,

a deployable first assembly including a pair of first members, a first arcuate element extending between the first members and configured to receive and hold the first spinous process, and at least one first hinge with a first pin rotatably coupling the first members to the central body such that the first arcuate element moves away from the long axis of the central body to push against the first spinous process when the spacer device moves toward the deployed configuration, the long axis is oriented generally in an anterior-to-posterior direction relative to the spinal motion segment, and ends of the first members move along opposite sides of the first spinous process, and

a deployable second assembly including a pair of second members, a second arcuate element extending between the second members and configured to receive and hold the second spinous process, and at least one second hinge with a second pin rotatably coupling the pair of second members to the central body such that the second arcuate element moves away from the long axis of the central body to push against the second spinous process when the spacer device moves toward the deployed configuration, the long axis is oriented generally in the anterior-to-posterior direction relative to the spinal motion segment, and ends of the second members move along opposite sides of the second spinous process.

12. The system of claim 11, further comprising a delivery tool configured to engage a tool interface of the spacer device when the delivery tool extends in a direction generally parallel to the anterior-to-posterior direction relative to the spinal motion segment and when the spacer device is positioned between the first and second spinous processes.

13. The system of claim 12, wherein the delivery tool is configured to extend in a substantially midline direction relative to the spinal motion segment when the delivery tool causes rotation of the first members in a first direction and rotation of the second members in a second direction opposite the first direction.

14. The system of claim 12, wherein the spacer device and the delivery tool are configured for a ratchet, threaded, or quick-release connection.

15. The system of claim 11, wherein the ends of the first and second members move away from the central body when the spacer device moves from the undeployed configuration toward the deployed configuration.

16. The system of claim 11, wherein the first and second members are generally parallel to the long axis of the central body when the spacer device is in the undeployed configuration, and wherein the first and second members are generally perpendicular to the long axis of the central body when the spacer device is in the deployed configuration.

17. The system of claim 11, wherein the first arcuate element is configured to extend across the first spinous process such that the first spinous process is located between ends of the first arcuate element located on opposite sides of the first spinous process, and wherein the second arcuate element is configured to extend across the second spinous process such that the second spinous process is located between ends of the second arcuate element located on opposite sides of the second spinous process.

18. The system of claim 11, wherein the spacer device in the undeployed configuration has an axial dimension and a radial dimension substantially transverse to the axial dimension, wherein the spacer device in the deployed configuration has an axial dimension and a radial dimension substantially transverse to the axial dimension, and wherein the radial dimension of the undeployed configuration is less than the radial dimension in the deployed configuration.

19. The system of claim 18, wherein the radial dimension is defined at least in part by a plurality of radially expanding members.

20. The system of claim 11, wherein the spacer device is configured to be driven from the undeployed configuration to the deployed configuration by a delivery instrument detachably coupled to the spacer device and configured to be positioned along an anterior to posterior midline approach.

21. The system of claim 11, wherein the spacer device includes a hub, wherein the first and second assemblies are rotatably coupled to the hub such that the first and second assemblies rotate by relative movement between the central body and the hub.

22. The system of claim 11, wherein the first and second members are generally parallel to the long axis of the central body when the spacer device is in the undeployed configuration and are generally perpendicular to the long axis of the central body when the spacer device is in the deployed configuration.

23. The system of claim 11, wherein the first and second members comprise metal.

24. The system of claim 11, wherein the first hinge includes a first pin that rotatably couples the deployable first assembly to the central body, and the second hinge includes a second pin that rotatably couples the deployable second assembly to the central body.

25. A system for stabilizing a spinal motion segment comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the system comprising:

a spacer device having an undeployed configuration for delivery between the first and second spinous processes and a deployed configuration for stabilizing the spinal motion segment after implantation of the spacer device, the spacer device including—

a central body having a long axis,

a deployable first assembly including a pair of first members, a first arcuate element extending between the first members and configured to receive and hold the first spinous process, and at least one first hinge rotatably coupling the first members to the central body such that the first arcuate element moves away from the long axis of the central body to push against the first spinous process when the spacer device moves toward the deployed configuration and ends of the first members move along opposite sides of the first spinous process, and

a deployable second assembly including a pair of second members, a second arcuate element extending between the second members and configured to receive and hold the second spinous process, and at least one second hinge rotatably coupling the pair of second members to the central body such that the second arcuate element moves away from the long axis of the central body to push against the second spinous process when the spacer device moves toward the deployed configuration and ends of the second members move along opposite sides of the second spinous process; and

wherein the first and second members are linkages.

26. A system for treating a subject'"'"'s spine comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the system comprising:

an implantable spacer device configured to space apart the first and second spinous processes, the implantable spacer device including—

a drive assembly configured to be mechanically driven by a delivery instrument releasably coupled to the implantable spacer device,

a first assembly hingedly coupled to the drive assembly and configured to receive and hold the first spinous process, the first assembly including a pair of first members having first and second ends, wherein the second ends of the first members move along opposite lateral sides of the first spinous process when the delivery instrument drives the drive assembly to cause rotation of the first ends, and

a second assembly hingedly coupled to the drive assembly and configured to receive and hold the second spinous process, the second assembly including a pair of second members having first and second ends, wherein the second ends of the second members move along opposite lateral sides of the second spinous process when the delivery instrument drives the drive assembly to cause rotation of the first ends of the second members.

27. The system of claim 26, wherein the drive assembly has a long axis that extends in a generally anterior-to-posterior direction relative to the spine when the first spinous process is between the first members and the second spinous process is between the second members.

28. The system of claim 26, wherein the first and second members are rotatable between undeployed orientations for positioning within an interspinous space between the first and second spinous processes and deployed orientations at which the first and second members extend out of the interspinous space.

29. The system of claim 26, wherein the first and second members in undeployed orientations extend in a direction generally parallel to a longitudinal axis of the drive assembly.

30. The system of claim 26, further comprising:

a first bracket extending between the first members and positionable to contact the first spinous process, and

a second bracket extending between the second members and positionable to contact the second spinous process to space apart the first and second spinous processes when the drive assembly is driven by the delivery instrument so as to cause the first and second assemblies to move from an undeployed configuration to a deployed configuration.

31. The system of claim 26, wherein the drive assembly includes a central body with a long axis, wherein the first members are generally parallel to the long axis when the first assembly is in an undeployed configuration and generally perpendicular to the long axis when the first assembly is in a deployed configuration, and wherein the second members are generally parallel to the long axis when the second assembly is in an undeployed configuration and generally perpendicular to the long axis when the second assembly is in a deployed configuration.

32. A system for treating a subject'"'"'s spine comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the system comprising:

an implantable spacer device configured to space apart the first and second spinous processes, the implantable spacer device including—

a first assembly configured to receive the first spinous process;

a second assembly configured to receive the second spinous process; and

a drive assembly being configured to be releasably coupled to a delivery instrument, wherein the drive assembly includes a central body with a long axis and is rotatably coupled to the first and second assemblies such that the first assembly is generally parallel to the long axis when the first assembly is in an undeployed configuration and generally perpendicular to the long axis when the first assembly is in a deployed configuration, and wherein the second assembly is generally parallel to the long axis when the second assembly is in an undeployed configuration and generally perpendicular to the long axis when the second assembly is in a deployed configuration.

33. The system of claim 32, wherein the first and second assemblies are rotatably coupled to an end of the drive assembly and are positioned to extend in an anterior-to-posterior direction when the drive assembly is positioned directly between the first and second spinous processes and the long axis of the central body extends in a direction substantially parallel to the anterior-to-posterior direction.

34. The system of claim 32, further comprising:

a first hinge pin rotatably coupling the deployable first assembly to the drive assembly; and

a second hinge pin rotatably coupling the deployable second assembly to the drive assembly.