Systems and methods for posterior dynamic stabilization of the spine

• US 8,409,282 B2
• Filed: 07/26/2005
• Issued: 04/02/2013
• Est. Priority Date: 10/20/2004
• Status: Expired due to Fees

• 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): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US11/190,496
• Publication Number:
  US 20060085070A1
• Time in Patent Office: 2,807 Days
• Field of Search: 606/249, 606/248, 623/17.11, 623/17.12
• 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
• 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; and

wherein the radial dimension of the undeployed configuration is less than the radial dimension in the deployed configuration, the radial dimension is defined at least in part by a plurality of radially expanding members, the radially expanding members comprise linkages, and wherein the device further comprises a plurality of brackets and each bracket has a substantially rigid central portion and two substantially flexible lateral portions,

wherein, when the device is in the deployed configuration, at least one of the brackets extends between one of the radially expanding members positioned on a first side of the first spinous process and one of the radially expanding members positioned on a second side of the first spinous process such that the bracket extends transversely across and holds the first spinous process.

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 brackets comprise a first bracket extending between a first pair of the radially expandable members and a second bracket extending between a second pair of the radially expandable members.

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

19. The device of claim 1, wherein the bracket is configured to contact and extend about a portion of the first spinous process facing the second spinous process.

5. An interspinous device for stabilizing at least one spinal motion segment comprising a superior vertebra having a superior spinous process and an inferior vertebra having an inferior spinous process, the interspinous device comprising:

a central member having an anterior-posterior axis;

a plurality of spinous process engagement members operatively coupled to the central member, wherein the spinous process engagement members are configured to move between an unexpanded condition and an expanded condition, wherein the plurality of spinous process engagement members are configured to expand concurrently, and wherein the spinous process engagement members are (a) parallel to the central member in the unexpanded condition and (b) extend outward from the central member in the expanded condition to seat the superior and inferior spinous;

a support element comprising a bracket configured to seat one of the superior spinous process or the inferior spinous process, the support element is coupled to the spinous process engagement members such that the support element moves away from the central member, the support element is configured to receive and hold one of the superior spinous process and the inferior spinous process when the spinous process engagement members to which the support element is coupled move from the unexpanded condition to the expanded condition; and

a posteriorly accessible tool interface configured to engage a delivery tool for moving the spinous process engagement members from the unexpanded condition to the expanded condition.

6. The interspinous device of claim 5 wherein the spinous process engagement members comprise struts.

7. The interspinous device of claim 5 wherein the spinous process engagement members comprise linkages.

8. The interspinous device of claim 5, further comprising a first hub at an anterior end of the central member and a second hub at a posterior end of the central member, and wherein the spinous process engagement members comprise linkage pairs coupled to the first and second hubs.

9. The interspinous device of claim 8 wherein individual linkage pairs comprise a first link pivotally coupled to the first hub, a second link pivotally coupled to the second hub, and a hinge connecting the first link to the second link.

10. The interspinous device of claim 5 wherein the bracket comprises a saddle.

11. A system for stabilizing at least one spinal motion segment having a first vertebra with a first spinous process, a second vertebra with a second spinous process, and an interspinous space between the first and second spinous processes, the system comprising:

an interspinous device comprising13

a central member having an anterior-posterior axis;

a plurality of spinous process engagement members, wherein the spinous process engagement members are configured to move between an unexpanded condition and an expanded condition, wherein the spinous process engagement members are configured to expand concurrently, and wherein the spinous process engagement members are (a) parallel to the central member in the unexpanded condition and (b) extend outward from the central member in the expanded condition to seat the first and second spinous processes;

a support element comprising a bracket configured to seat one of the first and second spinous processes, the support element is coupled to a pair of the spinous process engagement members such that the support element moves away from the central member and is configured to bear against and hold one the first spinous process and the second spinous process when the pair of spinous process engagement members move from the unexpanded condition to the expanded condition;

a posteriorly accessible tool interface configured to engage a delivery tool for moving the spinous process engagement member from the unexpanded condition to the expanded condition; and

a delivery tool for engaging the tool interface and delivering the interspinous device in the unexpanded condition within the interspinous space and for expanding the interspinous device from the unexpanded condition to the expanded condition.

12. The system of claim 11, wherein the interspinous device is configured for delivery by the delivery tool through posterior a midline incision.

13. 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 location posterior of the interspinous space;

inserting an interspinous device into the interspinous space by moving the interspinous device through the incision along a posterior-anterior path,

wherein the interspinous device comprises—

a central member having an anterior-posterior axis,

a plurality of spinous process engagement members operatively coupled to the central member, wherein the spinous process engagement members are configured to move between an unexpanded condition and an expanded condition, wherein the plurality of spinous process engagement members are configured to expand concurrently, and wherein the spinous process engagement members are (a) parallel to the central member in the unexpanded condition and (b) extend outward from the central member in the expanded condition to seat the superior and inferior spinous, and

a support element comprising a bracket configured to seat one of the superior spinous process or the inferior spinous process; and

changing the interspinous device from an unexpanded configuration to an expanded configuration, wherein the interspinous device has a low profile in the unexpanded configuration in which the spinous process engagement members are parallel to the posterior-anterior path, and wherein the spinous engagement members extend outwardly away from the posterior-anterior path in the expanded condition.

14. The method of claim 13 wherein creating the incision further comprises forming the incision along the midline posterior of the interspinous space and inserting the interspinous device comprises passing the interspinous device through the midline incision.

15. The method of claim 13 wherein creating the incision further comprises forming the incision through the supraspinous ligament and inserting the interspinous device comprises passing the interspinous device through the supraspinous ligament.

16. The method of claim 13, further comprising contacting the superior spinous process and the inferior spinous process with the interspinous device to stabilize the superior vertebra relative to the inferior vertebra.

17. The method of claim 13, wherein changing the interspinous device from the unexpanded configuration to the expanded configuration includes contacting a bottom region of the superior spinous process with the interspinous device and contacting an upper region of the inferior spinous process with the interspinous device.

18. The method of claim 13, wherein changing the interspinous device from the unexpanded configuration to the expanded configuration comprises moving the interspinous device using a delivery tool which extends through the supraspinous ligament.