Systems and methods for posterior dynamic stabilization of the spine

• US 9,877,749 B2
• Filed: 10/30/2014
• Issued: 01/30/2018
• 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:
  US14/528,963
• Publication Number:
  US 20150150604A1
• Time in Patent Office: 1,188 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 17/7068 Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; 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 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. A method for spacing apart a superior spinous process and an inferior spinous process of a subject, the method comprising:

positioning an interspinous spacer device between the superior and inferior spinous processes, the interspinous spacer device including a main body, a pair of superior elongate members, a pair of inferior elongate members, a movable superior central section extending between the superior elongate members, and a movable inferior central section extending between the inferior elongate members, wherein the movable superior central section extends across most of a first distance between the superior elongate members and/or the movable inferior central section extends across most of a second distance between the inferior elongate members;

moving the interspinous spacer device from a delivery configuration toward a deployed H-shaped configuration using an instrument coupled to the interspinous spacer device such that the superior elongate members rotate relative to the main body and move along opposite sides of the superior spinous process, the inferior elongate members rotate relative to the main body and move along opposite sides of the inferior spinous process, and regions of the superior and inferior central sections are positioned along a sagittal plane of the subject and translate away from one another and toward the superior and inferior spinous processes, wherein the superior and inferior elongate members are substantially parallel to a longitudinal axis of the interspinous spacer device when the interspinous spacer device is in the delivery configuration, wherein the sagittal plane passes through the superior and inferior spinous processes; and

separating the instrument from the interspinous spacer device after the superior and inferior central sections extend laterally across the sagittal plane and across the superior and inferior spinous processes, respectively, and the interspinous spacer device is in the deployed H-shaped configuration.

2. The method of claim 1, wherein the superior spinous process is held between the superior elongate members and the inferior spinous process is held between the inferior elongate members when the instrument is separated from the interspinous spacer device.

3. The method of claim 1, wherein positioning the interspinous spacer device between the superior and inferior spinous processes comprises:

moving at least a portion of a delivery cannula into the subject; and

translating the interspinous spacer device through and out of the delivery cannula.

4. The method of claim 1, wherein positioning the interspinous spacer device between the superior and inferior spinous processes comprises:

moving an end of a cannula into the subject; and

moving the interspinous spacer device along a lumen of the cannula while the cannula is positioned in the subject.

5. The method of claim 4, wherein the interspinous spacer device is moved from the delivery configuration toward the deployed H-shaped configuration while the instrument extends through the cannula.

6. The method of claim 5, wherein the instrument is configured to controllably move the interspinous spacer device from the delivery configuration toward the deployed H-shaped configuration and to controllably move the interspinous spacer device from the deployed H-shaped configuration toward the delivery configuration.

7. The method of claim 1, wherein moving the interspinous spacer device from the delivery configuration toward the deployed H-shaped configuration includes rotating the superior and inferior elongate members from a collapsed axial configuration to a deployed orthogonal configuration.

8. The method of claim 1, wherein the interspinous spacer device comprises a metal H-shaped structure.

9. The method of claim 1, wherein the superior elongate members and the superior central section define a U-shape, and wherein the inferior elongate members and the inferior central section define a U-shape.

10. The method of claim 1, further comprising:

positioning a cannula in the subject;

moving a cutting instrument through the cannula and into the subject; and

cutting tissue of the subject using the cutting instrument to provide access to an interspinous space between the superior and inferior spinous processes.

11. The method of claim 1, wherein the main body is positioned directly between the superior spinous process and the inferior spinous process while the superior and inferior central sections, which are part of the main body, move away from one another.

12. The method of claim 1, further comprising:

anchoring one of the superior elongate members to the superior spinous process; and

anchoring one of the inferior elongate members to the inferior spinous process.

13. The method of claim 1, wherein the instrument is configured to move the interspinous spacer device from the deployed H-shaped configuration to a collapsed configuration while the instrument is coupled to the interspinous spacer device.

14. The method of claim 1, wherein the regions of the superior and the inferior central sections are positioned across the sagittal plane while the inferior spinous process is positioned between the inferior elongate members and while the superior spinous process is positioned between the superior elongate members.

15. The method of claim 1, wherein a superior surface extends continuously along the superior central section and the superior elongate members, wherein an inferior surface extends continuously along the inferior central section and the inferior elongate members, wherein the entire lengths of the superior and inferior surfaces along the superior and inferior central sections move away from one another when the interspinous spacer device moves toward the deployed H-shaped configuration.

16. The method of claim 1, wherein the region of the superior central sections is generally midway between the superior elongate members, and wherein the region of the inferior central section is generally midway between the inferior elongate members.

17. A method for spacing apart a superior spinous process and an inferior spinous process of a subject, the method comprising:

positioning an interspinous spacer device between the superior and inferior spinous processes, the interspinous spacer device including a main body, a pair of superior elongate members, a pair of inferior elongate members, a movable superior central section extending between the superior elongate members, and a movable inferior central section extending between the inferior elongate members, wherein the superior elongate members are foldable against the main body, wherein the movable superior central section extends across most of a first distance between the superior elongate members and/or the movable inferior central section extends across most of a second distance between the inferior elongate members;

moving the interspinous spacer device from a delivery configuration toward a deployed H-shaped configuration using an instrument coupled to the interspinous spacer device such that the superior elongate members rotate relative to the main body and move along opposite sides of the superior spinous process, the inferior elongate members rotate relative to the main body and move along opposite sides of the inferior spinous process, and regions of the superior and inferior central sections are positioned along a sagittal plane of the subject and translate away from one another and toward the superior and inferior spinous processes, wherein the sagittal plane passes through the superior and inferior spinous processes; and

separating the instrument from the interspinous spacer device after the superior and inferior central sections extend laterally across the sagittal plane and across the superior and inferior spinous processes, respectively, and the interspinous spacer device is in the deployed H-shaped configuration.

18. A method for spacing apart a first spinous process and a second spinous process, the method comprising:

positioning an interspinous spacer device at an interspinous space between the first and second spinous processes;

rotating a pair of first elongate members of the interspinous spacer device from a first delivery configuration toward a first deployed configuration, wherein the first elongate members in the first delivery configuration are substantially parallel to a longitudinal axis of the interspinous spacer device;

rotating a pair of second elongate members of the interspinous spacer device from a second delivery configuration toward a second deployed configuration, wherein the second elongate members in the second delivery configuration are substantially parallel to the longitudinal axis of the interspinous spacer device;

moving first and second central sections toward the first and second spinous processes, respectively, while both the first and second central sections are positioned across a subject'"'"'s sagittal plane passing through the first and second spinous processes, respectively, and wherein the first central section extends across most of a distance between the first elongate members; and

separating a delivery instrument from the interspinous spacer device when the interspinous spacer device is in a deployed H-shaped configuration and when the first and second elongate members are in the first and second deployed configurations, respectively.

19. The method of claim 18, wherein positioning the interspinous spacer device at the interspinous space comprises:

moving at least a portion of a delivery cannula into the subject;

translating the interspinous spacer device along the delivery cannula which is positioned in the subject; and

moving the interspinous spacer device out an end of the delivery cannula which is positioned in the subject.

20. The method of claim 18, wherein positioning the interspinous spacer device comprises:

moving an end of a cannula into the subject; and

moving the interspinous spacer device along the cannula and out the end of the cannula.

21. The method of claim 20, wherein the interspinous spacer device is moved from the delivery configuration toward the deployed H-shaped configuration while the instrument extends through the cannula.

22. The method of claim 18, wherein the interspinous spacer device comprises a deployable metal H-shaped structure.

23. The method of claim 18, further comprising:

positioning a cannula in the subject;

delivering a cutting instrument through the cannula and into the subject; and

cutting tissue of the subject to provide access to the interspinous space for positioning the interspinous spacer device at the interspinous space.

24. The method of claim 18, further comprising:

moving a first anchor into the first spinous process to couple one of the first elongate members to the first spinous process; and

moving a second anchor into the second spinous process to couple one of the second elongate members to the second spinous process.

25. The method of claim 24, wherein at least one of the first and second anchors includes a screw, a tack, or a staple.

26. The method of claim 18, further comprising rotating the first elongate members toward the first deployed configuration using the delivery instrument after the entire interspinous spacer device has been delivered out of a delivery cannula.

27. The method of claim 18, wherein a region of the first central section that moves toward the first spinous process is positioned generally midway between the first elongate members.

28. The method of claim 18, wherein the first and second central sections are contoured to seat against the first and second spinous processes, respectively.

29. The method of claim 18, wherein the first elongate members and/or second elongate members are foldable against a main body of the interspinous spacer device.

30. A method comprising:

positioning an interspinous spacer device at an interspinous space between first and second spinous processes of a subject;

moving a pair of first elongate members of the interspinous spacer device from a first delivery configuration toward a first deployed configuration, wherein the first elongate members in the first delivery configuration are substantially parallel to a longitudinal axis of the interspinous spacer device;

moving a pair of second elongate members of the interspinous spacer device from a second delivery configuration toward a second deployed configuration;

moving first and second central sections of the interspinous spacer device toward the first and second spinous processes, respectively, wherein a portion of the first central section that moves toward the first spinous process extends across most of a distance between the first elongate members; and

expanding a narrowed section of the interspinous spacer device to translate the first and second central sections in the opposite directions, wherein the first and second central sections are part of the narrowed section, and wherein the narrowed section is positioned between the first elongate members and is positioned between the second elongate members.

31. The method of claim 30, wherein the first and second central sections both extend across a sagittal plane passing through the first and second spinous processes while the first and second central sections move toward the respective first and second spinous processes.

32. The method of claim 30, wherein when the first and second central sections move toward the respective first and second spinous processes, the first elongate members are on opposite sides of the sagittal plane and the second elongate members are on opposite sides of the sagittal plane.

33. The method of 30, wherein the first elongate members and/or second elongate members are foldable against a main body of the interspinous spacer device.