Systems and methods for posterior dynamic stabilization of the spine

• US 10,039,576 B2
• Filed: 09/04/2015
• Issued: 08/07/2018
• 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:
  US14/846,608
• Publication Number:
  US 20160066963A1
• Time in Patent Office: 1,068 Days
• 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 method for treating a subject, comprising:

forming an opening at a location posterior to the subject'"'"'s supraspinous ligament;

moving a cannula through the opening;

positioning the cannula directly between adjacent spinous processes;

moving a treatment apparatus in a posterior-anterior direction relative to the subject such that at least a portion of the treatment apparatus moves out an end portion of the cannula and into an interspinous space between the adjacent spinous processes; and

performing at least a portion of a spinal procedure using the treatment apparatus while the treatment apparatus is positioned in the cannula located in the opening, a mid-sagittal plane of the subject extends through the end portion of the cannula, and the treatment apparatus is positioned directly between the adjacent spinous processes, wherein the spinal procedure is a nerve decompression procedure.

2. The method of claim 1, further comprising:

incising the subject'"'"'s skin to form the opening; and

moving the cannula through the opening such that the cannula moves through the subject'"'"'s supraspinous ligament.

3. The method of claim 1 wherein the cannula has a longitudinal axis that is at a generally anterior-to-posterior orientation relative to the subject when performing at least the portion of the spinal procedure.

4. The method of claim 1, further comprising moving the cannula along a delivery path that is substantially parallel to the mid-sagittal plane to advance the cannula into the subject.

5. The method of claim 1, further comprising:

forming an opening in the subject'"'"'s supraspinous ligament; and

moving the cannula through the opening in the subject'"'"'s supraspinous ligament to advance the cannula into the subject.

6. The method of claim 1 wherein the opening is at a location that is posterior to an interspinous space, the method further comprising:

moving an end of the cannula toward the interspinous space; and

manipulating an end of the treatment apparatus while the treatment apparatus is positioned within the cannula to perform the portion of the spinal procedure.

7. The method of claim 1, further comprising moving a sharp distal tip of the cannula into the subject to penetrate the subject'"'"'s tissue.

8. The method of claim 1, further comprising penetrating the subject'"'"'s tissue using a trocar, a cutting instrument, or a cannulation instrument.

9. The method of claim 1 wherein the cannula is configured to provide access to a treatment site for all surgical instruments used to perform the spinal procedure.

10. The method of claim 1, further comprising distracting adjacent vertebrae prior to inserting the treatment apparatus into an interspinous space between the adjacent vertebrae.

11. The method of claim 1, further comprising viewing the treatment apparatus using fluoroscopy.

12. The method of claim 1, wherein the nerve decompression procedure includes distracting the adjacent spinous processes to cause retraction of a bulging or distended portion of an intervertebral disk.

13. The method of claim 1, wherein the nerve decompression procedure includes implanting a spinal spacer device.

16. The method of claim 1, further comprising:

moving an instrument through the opening to separate the supraspinous ligament.

17. The method of claim 16 wherein the instrument is a trocar or a cutting instrument.

18. The method of claim 16 wherein the instrument has a sharp distal end configured to split the supraspinous ligament.

14. A method for treating a subject comprising:

forming an opening at a location posterior to the subject'"'"'s supraspinous ligament;

moving a cannula through the opening;

positioning the cannula directly between adjacent spinous processes;

moving a treatment apparatus in a posterior-anterior direction relative to the subject such that at least a portion of the treatment apparatus moves out an end portion of the cannula and into an interspinous space between the adjacent spinous processes; and

performing at least a portion of a spinal procedure using the treatment apparatus while the treatment apparatus is positioned in the cannula located in the opening and a mid-sagittal plane of the subject extends through the end portion of the cannula positioned directly between the adjacent spinous processes, wherein performing the portion of the spinal procedure includes deploying an interspinous spacer device of the treatment apparatus to distract and/or stabilize adjacent vertebrae.

15. The method of claim 14, further comprising mechanically deploying the interspinous spacer device using a delivery instrument of the treatment apparatus positioned in the cannula while a longitudinal axis of the delivery instrument is at a substantially anterior-to-posterior orientation relative to the subject.

19. A method for treating a subject, comprising:

forming an opening at a location posterior to the subject'"'"'s supraspinous ligament;

moving a cannula through the opening;

positioning the cannula directly between adjacent spinous processes;

moving a treatment apparatus in a posterior-anterior direction relative to the subject such that at least a portion of the treatment apparatus moves out an end portion of the cannula and into an interspinous space between the adjacent spinous processes, wherein the treatment apparatus includes an interspinous spacer device and a delivery instrument, and wherein the delivery instrument is configured to mechanically expand the interspinous spacer device and is configured to release the interspinous spacer device; and

performing at least a portion of a spinal procedure using the treatment apparatus while the treatment apparatus is positioned in the cannula located in the opening, a mid-sagittal plane of the subject extends through the end portion of the cannula, and the treatment apparatus is positioned directly between the adjacent spinous processes.

20. A method for treating a subject, comprising:

moving a tissue-penetrating instrument through the subject'"'"'s skin and supraspinous ligament;

positioning a cannula through the supraspinous ligament;

removing the tissue-penetrating instrument from the cannula while the cannula extends through the supraspinous ligament; and

delivering a treatment apparatus through the cannula to move the treatment apparatus toward a space between adjacent vertebrae while at least a portion of the cannula is positioned directly between the adjacent vertebrae and along the subject'"'"'s mid-sagittal plane; and

performing at least a portion of a nerve decompression procedure using the treatment apparatus while the treatment apparatus is positioned in the cannula that extends through the supraspinous ligament.

21. The method of claim 20 wherein the tissue-penetrating instrument includes a trocar or a cannulation instrument.

22. The method of claim 20, further comprising:

forming an incision generally along the subject'"'"'s midline; and

moving the tissue-penetrating instrument through the incision to split the supraspinous ligament.

23. The method of claim 20 wherein the cannula is configured to provide access to an internal treatment site for surgical instruments used to perform a nerve decompression procedure at the internal treatment site.

24. The method of claim 20, further comprising separating interspinous tissue by advancing the tissue-penetrating instrument through the supraspinous ligament.

25. A method for treating a subject, comprising:

moving a tissue-penetrating instrument through the subject'"'"'s skin and supraspinous ligament;

positioning a cannula through the supraspinous ligament;

removing the tissue-penetrating instrument from the cannula while the cannula extends through the supraspinous ligament;

delivering a treatment apparatus through the cannula to move the treatment apparatus toward a space between adjacent vertebrae while at least a portion of the cannula is positioned directly between the adjacent vertebrae and along the subject'"'"'s mid-sagittal plane, wherein the treatment apparatus includes a delivery instrument and an interspinous device;

expanding the interspinous device using the delivery instrument;

releasing the interspinous device from the delivery instrument; and

removing the delivery instrument from the cannula after releasing the interspinous device within the subject.

26. A method for treating a subject, comprising:

moving a cannula into the subject using a midline approach;

moving a deployable device through the cannula while an end of the cannula is positioned directly between midplanes of two spinous processes;

positioning the deployable device at an interspinous space;

expanding the deployable device after positioning the deployable device at the interspinous space to distract and/or stabilize adjacent vertebrae with the two spinous processes;

releasing the deployable device from a delivery instrument positioned in the cannula; and

removing the delivery instrument from the cannula after releasing the deployable device within the subject.

27. The method of claim 26, further comprising holding the cannula at a substantially anterior-to-posterior orientation within the subject while moving the deployable device along a lumen of the cannula.

28. The method of claim 26 wherein moving the cannula into the subject includes advancing the cannula through the subject'"'"'s supraspinous ligament.

29. The method of claim 26 wherein moving the cannula into the subject includes moving a distal end of the cannula through an elongate slit in the subject'"'"'s supraspinous ligament.

30. The method of claim 26, further comprising distracting the adjacent vertebrae prior to expanding the deployable device.

31. The method of claim 26, further comprising viewing the deployable device in the subject using fluoroscopy.

32. The method of claim 26, wherein the deployable device has a generally cylindrical undeployed configuration and a H-shaped deployed configuration.

33. A method for treating a subject, comprising:

forming a midline opening;

moving a cannula through the midline opening to separate tissue positioned directly between adjacent spinous processes;

delivering a cutting instrument through the cannula to cut tissue while the cannula is positioned in the midline opening and the subject'"'"'s mid-sagittal plane extends through an end portion of the cannula and is located directly between the adjacent spinous processes;

removing the cutting instrument from the cannula;

delivering an interspinous spacer device through the cannula after removing the cutting instrument; and

deploying the interspinous spacer device using a delivery instrument positioned in a lumen of the cannula.

34. The method of claim 33, further comprising cannulating tissue using one or more of K-wire, a trocar, a cutting tool, and/or a delivery cannula.