Systems and methods for posterior dynamic stabilization of the spine

• US 8,628,574 B2
• Filed: 07/27/2010
• Issued: 01/14/2014
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Altarac, Moti, Flaherty, J. Christopher
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/844,365
• Publication Number:
  US 20110106160A1
• Time in Patent Office: 1,267 Days
• Field of Search: 623 1711- 1716, 606/90, 606246-249
• US Class Current: 623/17.11
• 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

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. 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 device 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 expandable spacer

having an undeployed configuration with an undeployed axial dimension, and a deployed configuration having a deployed axial dimension, the undeployed axial dimension is greater than the deployed axial dimension, the expandable spacer including;

a plurality of first deployable segments, at least one of the first deployable segments including a first vertebra receiving feature configured to receive the first vertebra when a longitudinal axis of the expandable spacer extends substantially transversely to a sagittal plane, and

a plurality of second deployable segments, at least one of the second deployable segments including a second vertebra receiving feature configured to receive the second vertebra when the longitudinal axis of the expandable spacer extends substantially transversely to the sagittal plane, wherein the first segment with the first vertebra receiving feature and the second segment with the second vertebra receiving feature move away from the longitudinal axis of the expandable spacer such that the first vertebra is moved into the first vertebra receiving feature and the second vertebra is moved into the second vertebra receiving feature when a deployment device is coupled to the expandable spacer and the deployment device moves the expandable spacer from the undeployed configuration to the deployed configuration.

2. The device of claim 1, wherein a distal end of the expandable spacer is coupled to a tip.

3. The device of claim 1, wherein the device in the undeployed configuration has a cylindrical shape.

4. The device of claim 1, wherein a cross-sectional shape of the expandable spacer varies smoothly.

5. The device of claim 1, wherein a cross-sectional shape of the expandable spacer varies continuously.

6. The device of claim 1, further comprising a tip disposed adjacent to and distal to a distal end of the expandable spacer, and further comprising a shaft coupled to the tip and disposed adjacent to and proximal of a proximal end of the expandable spacer, wherein the shaft is moveable relative to the expandable spacer to move the expandable spacer from the undeployed configuration to the deployed configuration.

7. The device of claim 1, further comprising a ratchet assembly and catch coupled to the expandable spacer, such that movement of the catch relative to the ratchet assembly causes the deployment of the expandable spacer.

8. The device of claim 1, further comprising a threaded shaft assembly and a release mechanism within the threaded shaft assembly, the threaded shaft assembly is rotatable to deploy the expandable spacer, and the threaded shaft assembly is configured to allow removal of a portion of the threaded shaft assembly following deployment.

9. The device of claim 7, further comprising a release mechanism within the ratchet assembly, to allow removal of a portion of the ratchet assembly following deployment.

10. The device of claim 1, wherein the first deployable vertebra receiving feature is a recess.

11. The device of claim 1, wherein the at least one of the first and second segments has a projection for engaging an adjacent deployable segment.

12. The device of claim 1, wherein the expandable spacer includes a covering.

13. 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 delivery device for delivering the device in the undeployed configuration between the interspinous processes and for radially expanding the device from the undeployed configuration to the deployed configuration.

14. The system of claim 13, wherein the device is configured for delivery by the delivery device through a midline incision.

15. A method for stabilizing a vertebra relative to another vertebra wherein the vertebrae define an interspinous space therebetween, the method comprising:

introducing the device of claim 1 within the interspinous space when in the undeployed configuration; and

radially expanding the device to selectively distract the spinous processes.

16. The method of claim 15, further comprising forming an incision along the midline above the interspinous space, wherein the introducing the interspinous device comprises inserting the device within the midline incision.

17. 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 expandable spacer comprising at least two first segments and at least two second segments, wherein the first segments engage each other such that a force along an axis causes at least one of the first segments having a first U-shaped recess to move in a first direction with a component perpendicular to the axis to receive a first spinous process of the first vertebra within the first U-shaped recess, and the second segments engage each other such that the force causes at least one of the second segments having a second U-shaped recess to move in a second direction with a component perpendicular to the axis to receive a second spinous process of the second vertebra within the second U-shaped recess.

18. An apparatus 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 apparatus comprising:

an expandable device configured to be coupled to a mechanical actuation device configured to move the expandable device from an undeployed configuration to a deployed configuration, the expandable device including a plurality of segments movable relative to one another such that the segments on opposite sides of the expandable device move outwardly to receive and extend in a superior-inferior direction along opposite sides of a first spinous process of the first vertebra and in the superior-inferior direction along opposite sides of a second spinous process of the second vertebra when the expandable device extends substantially perpendicular to an anterior-to-posterior direction and when the expandable device is positioned between the first vertebra and the second vertebra and moves from the undeployed configuration to the deployed configuration.

19. The apparatus of claim 18, wherein the plurality of segments includes a plurality of first segments and a plurality of second segments, at least one of the first segments includes a first vertebra receiving feature configured to receive the first vertebra when a longitudinal axis of the expandable device extends substantially transversely to a sagittal plane, and wherein at least one of the second segments has a second vertebra receiving feature configured to receive the second vertebra when the longitudinal axis of the expandable device extends substantially transversely to the sagittal plane.

20. The apparatus of claim 19, wherein the first segment with the first vertebra receiving feature and the second segment with the second vertebra receiving feature move away from a longitudinal axis of the expandable device when a mechanical activation device is coupled to the expandable device and moves the expandable device from the undeployed configuration to the deployed configuration.

21. The apparatus of claim 18, further comprising a mechanical actuation device coupleable to the expandable device, the mechanical actuator device is operable to drive the segments radially outward from a longitudinal axis of the expandable device.

22. The apparatus of claim 21, wherein the mechanical actuation device includes a distal section and a proximal section, the distal section and the proximal section are movable relative to one another to compress the expandable device such that the expandable device moves from the undeployed configuration towards the deployed configuration.

23. The apparatus of claim 18, wherein adjacent segments are configured to be moved relative to one another as the expandable device moves from the undeployed configuration to the deployed configuration.

24. The apparatus of claim 18, wherein adjacent segments engage each other such that an axial force applied to the expandable device by a mechanical actuation device causes one or more of the segments to move away from a longitudinal axis of the expandable device.

25. The apparatus of claim 18, wherein the segments include a central segment having a first recess configured to receive the first spinous process, a proximal segment, and a distal segment, and wherein the central segment, the proximal segment, and the distal segment are movable outwardly from an undeployed position to a deployed position.

26. The apparatus of claim 25, wherein the central segment is configured to hold the first spinous process such that the proximal segment and the distal segment are positioned laterally of the first spinous process.