Systems and methods for posterior dynamic stabilization of the spine

• US 9,211,146 B2
• Filed: 02/27/2012
• Issued: 12/15/2015
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Kim, Daniel H.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US13/406,433
• Publication Number:
  US 20120330359A1
• Time in Patent Office: 1,387 Days
• Field of Search: 606/105, 606/198, 606/57, 606/248, 606/249, 606 86 A- 86 B, 606/90, 606/914, 606/99, 623/17.11, 623/17.12, 623/17.16, 623/23.67
• 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 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 or an expansion medium for injection within or for filling the interior of the expandable member via the port. 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 of a subject 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 an unexpanded configuration and an expanded configuration, wherein the expandable member in the unexpanded configuration has a size configured for delivery through a cannula and positioning between the first and second spinous process and in the expanded configuration provides distraction of the first and second spinous processes, wherein the expandable member includes

a first concave engagement portion,

a second concave engagement portion,

a hub,

at least one strut rotatably coupled to the hub, and

a central element positioned between the first and second concave engagement portions, wherein the central element is axially movable relative to the hub to cause the at least one strut to rotate relative to the hub to move the first and second concave engagement portions outwardly while the hub and the at least one strut are positioned with the subject and positioned directly posterior to the subject'"'"'s spinal motion segment and also while the central element is positioned directly between the first and second spinous processes to mechanically actuate the expandable member from the unexpanded configuration to the expanded configuration such that the first spinous process is held by the first concave engagement portion and the second spinous process is held by the second concave engagement portion.

2. The device of claim 1, wherein the at least one strut comprises a plurality of struts.

3. The device of claim 2, wherein the hub is a first hub and the interspinous device further includes a second hub, wherein the at least one strut includes struts affixed between the first and second hubs, wherein the first and second hubs are spaced apart a sufficiently small distance such that the first and second hubs are positionable on opposite sides of a sagittal plane defined by the spinal motion segment and within the subject when the first spinous process is held by the first concave engagement portion and the second spinous process is held by the second concave engagement portion.

4. A kit 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 kit comprising:

the interspinous device of claim 1; and

a cannula configured for percutaneous delivery to a target site within the spinal motion segment wherein the expandable member is deliverable through the cannula when in an unexpanded configuration.

5. The kit of claim 4, further comprising instructions for implanting the expandable member between the first and second spinous processes.

6. The device of claim 1, further comprising an expandable inflatable member positionable within the expandable member.

7. The device of claim 1 wherein the expandable member includes an inflatable member.

8. The device of claim 1, wherein the expandable member is configured to move in a first direction through the cannula and into the position between the first and second spinous processes, wherein the first concave engagement portion and the second concave engagement portion move away from each other in a second direction that is different from the first direction.

9. The device of claim 1, wherein the first and second concave engagement portions move away from a longitudinal axis of the expandable member when the expandable member moves from the unexpanded configuration to the expanded configuration.

10. The device of claim 1 wherein the first and second concave engagement portions move in opposite directions when the central element moves axially along the expandable member.

11. The device of claim 1 wherein the first and second concave engagement portions move laterally outwardly past a distal end of a cannula device for delivering the interspinous device when the expandable member is moved from the unexpanded configuration to the expanded configuration and is connected to the cannula device.

12. The device of claim 1 wherein the expandable member is configured to move from the expanded configuration to the unexpanded configuration while a cannula device is mechanically coupled to the expandable member.

13. The device of claim 1 wherein concave surfaces of the first and second concave engagement portions are positioned to contact and surround at least portions of the first and second spinous processes.

14. A system for stabilizing at least one spinal motion segment of a subject comprising a first vertebra having a first spinous process and a second vertebra having a second spinous process, the system comprising:

an expandable member including a first concave engagement portion, a second concave engagement portion, and rotatable members, wherein the rotatable members are rotatable about axes of rotation to move the first and second concave engagement portions such that the expandable member moves between an unexpanded configuration and an expanded configuration while each of the rotatable members are positioned within the subject and the rotatable members are located directly posterior to the spinal motion segment, wherein the expandable member in the unexpanded configuration has a size configured for delivery through a cannula and positioning between the first and second spinous process and in the expanded configuration provides distraction of the first and second spinous processes held within the first and second concave engagement portions, respectively, wherein the expandable member is mechanically actuatable from the unexpanded configuration to the expanded configuration; and

means for mechanically actuating the expandable member to move the first and second concave engagement portions toward the first and second spinous processes, respectively, while the means for mechanically actuating is positioned directly between the first and second spinous processes and movable axially along the expandable member.

15. The system of claim 14, wherein said mechanical actuation means is a guide wire.

16. The system of claim 14, wherein the first and second concave engagement portions move away from a longitudinal axis of the expandable member when the expandable member moves from the unexpanded configuration to the expanded configuration.

17. An interspinous system, comprising:

an implant assembly that is mechanically actuatable between a first unexpanded configuration and a first expanded configuration, wherein the implant assembly includes

an expandable device having a first concave engagement portion, a second concave engagement portion, and strut, and

a drive element axially movable along the expandable device to rotate the sruts so as to move the first and second concave engagement portions away from one another, wherein the implant assembly in the first unexpanded configuration is deliverable through a cannula and positionable between a first and second spinous process of a subject'"'"'s spine such that the first and second concave engagement portions and the drive member are positioned directly between the first and second spinous processes, and wherein when the implant assembly is in the first expanded configuration, the first and second concave engagement portions hold the first and second spinous processes, respectively, to provide distraction of the first and second spinous processes while the entire expandable device is positioned within the subject and positioned directly posterior to the subject'"'"'s spine.

18. The interspinous system of claim 17, wherein the expandable device is a first expandable device, and wherein the implant assembly further comprises:

a second expandable device that is inflatable between a second unexpanded configuration and a second expanded configuration.

19. The interspinous system of claim 18 wherein the second expandable device in the second unexpended configuration is positionable within the expandable device.

20. The interspinous system of claim 17, wherein the implant assembly has an elongated shape for delivery through an lumen of the cannula.

21. The interspinous system of claim 17, further comprising:

an implantable inflatable device inflatable between a second unexpanded configuration and a second expanded configuration such that the implantable inflatable device holds the first and second spinous processes while the implant assembly is collapsed and removed from the subject.

22. The interspinous system of claim 17 wherein concave surfaces of the first and second concave engagement portions are positioned to contact the first and second spinous processes.

23. An interspinous apparatus for distracting a first vertebra of a subject having a first spinous process and a second vertebra of the subject having a second spinous process, the interspinous apparatus comprising:

an implant assembly including a first concave engagement portion, a second concave engagement portion, a hub, at least one rotatable member, and a drive member, wherein the implant assembly has an unexpanded configuration and an expanded configuration, wherein the implant assembly in the unexpanded configuration is sized for delivery to a position between the first and second spinous processes such that the first and second concave engagement portions and the drive member are positioned directly between the first and second spinous processes, wherein the implant assembly is mechanically actuated from the unexpanded configuration to the expanded configuration by moving the drive member along the hub such that at least one rotatable member rotates relative to the hub to cause the first and second concave engagement portions to move away from a longitudinal axis of the implant assembly and to seat the first spinous process in the first concave engagement portion and to seat the second spinous process in the second concave engagement portion when the hub and the entire at least one rotatable member are positioned within the subject and positioned directly posterior to the subject'"'"'s spine.

24. The interspinous apparatus of claim 23, further comprising:

an implantable inflatable device inflatable from a first unexpanded configuration to a second expanded configuration such that the implantable inflatable device holds the first and second spinous processes while the implant assembly is collapsed and removed from the subject.

25. The interspinous apparatus of claim 23, wherein the first and second concave engagement portions move away from each other when the implant assembly moves towards the expanded configuration.

26. The interspinous apparatus of claim 23 wherein concave surfaces of the first and second concave engagement portions are positioned to contact the first and second spinous processes.