Systems and methods for posterior dynamic stabilization of the spine

• US 10,709,481 B2
• Filed: 12/04/2017
• Issued: 07/14/2020
• 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:
  US15/831,201
• Publication Number:
  US 20180193064A1
• Time in Patent Office: 953 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. An interspinous spacer device, comprising:

a port;

an expandable body comprising

a pair of superior apexes configured to be driven from a first delivery configuration toward a first deployed configuration by an instrument that is detachably coupled to the port spaced apart from the superior apexes, wherein the superior apexes in the first delivery configuration are substantially parallel to a longitudinal axis of the interspinous spacer device;

a recessed superior central section extending between the superior apexes and configured to gradually move toward a subject'"'"'s superior spinous process based on operation of the instrument coupled to the port of the interspinous spacer device while the superior spinous process is located between the superior apexes;

a pair of inferior apexes movable from a second delivery configuration toward a second deployed configuration by the instrument detachably coupled to the port, wherein the inferior apexes in the second delivery configuration are substantially parallel to the longitudinal axis of the interspinous spacer device; and

a recessed inferior central section extending between the inferior apexes and configured to gradually move toward a subject'"'"'s inferior spinous process based on operation of the instrument coupled to the port of the interspinous spacer device while the inferior spinous process is located between the inferior apexes.

2. The interspinous spacer device of claim 1, wherein the expandable body is configured to be detachably connected to the instrument via the port, the interspinous spacer device is movable from a delivery arrangement toward a deployed H-shaped arrangement based on operation of the instrument.

3. The interspinous spacer device of claim 2, wherein the port is connectable to the instrument such that the instrument operates to cause the superior apexes to rotate relative to the expandable body so as to move along opposite sides of the superior spinous process, the inferior apexes to rotate relative to the expandable body so as to move along opposite sides of the inferior spinous process, and wherein the recessed superior and inferior central sections are configured to be positioned along a sagittal plane of the subject while translating away from one another and toward the respective superior and inferior spinous processes.

4. The interspinous spacer device of claim 1, wherein the interspinous spacer device is configured to be gradually moved from a low-profile delivery configuration to an H-shaped configuration based on operation of the instrument and configured to be gradually moved from the H-shaped configuration to the low-profile delivery configuration based on operation of the instrument.

5. The interspinous spacer device of claim 1, wherein the superior apexes are spaced apart to hold the superior spinous process, and the inferior apexes are spaced apart to hold the inferior spinous process.

6. The interspinous spacer device of claim 1, wherein the interspinous spacer device is moved from a delivery arrangement toward a deployed H-shaped arrangement while the instrument is detachably coupled to the expandable body of the interspinous spacer device while the instrument extends through a cannula through which the interspinous spacer device in the delivery arrangement is configured to translate.

7. The interspinous spacer device of claim 1, wherein the instrument is configured to move the interspinous spacer device from the delivery arrangement toward a deployed H-shaped arrangement and to move the interspinous spacer device from the deployed H-shaped arrangement toward the delivery arrangement.

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

9. The interspinous spacer device of claim 1, wherein when the interspinous spacer device is in a deployed configuration, the superior apexes and the recessed superior central section define a U-shape and the inferior apexes and the recessed inferior central section define a U-shape.

10. The interspinous spacer device of claim 1, wherein after the instrument has been separated from the port, the deployed interspinous spacer device is configured to have an unconstrained H-shaped configuration.

11. The interspinous spacer device of claim 1, wherein the interspinous spacer device is configured to be gradually moved from a low-profile delivery configuration to an H-shaped configuration by operation of the instrument and without any external force being applied to the superior apexes.

12. An interspinous spacer device for deployment at an interspinous space between first and second spinous processes of a subject, the interspinous spacer device comprising:

a main body including a port;

a pair of first apexes connected to the main body and gradually movable from a first delivery configuration toward a first deployed configuration based on operation of an instrument detachably coupled to the port;

a pair of second apexes connected to the main body and gradually movable from a second delivery configuration toward a second deployed configuration based on operation of the instrument; and

first and second central sections of the interspinous spacer device movable toward the first and second spinous processes, respectively, to push apart the first and second spinous processes, wherein the first central section is between the first apexes and the second central section is between the second apexes.

13. The interspinous spacer device of claim 12, wherein the first and second central sections are both configured to extend across a sagittal plane passing through the subject'"'"'s first and second spinous processes while the first and second central sections move toward the respective first and second spinous processes.

14. The interspinous spacer device of claim 12, wherein the first apexes or the second apexes are foldable against the main body.

15. The interspinous spacer device of claim 12, wherein the first apexes and second apexes are foldable.

16. The interspinous spacer device of claim 12, wherein the interspinous spacer device is configured to be gradually moved from a low-profile delivery configuration to an H-shaped configuration based on operation of the instrument and configured to be gradually moved from the H-shaped configuration to the low-profile delivery configuration based on operation of the instrument.

17. The interspinous spacer device of claim 12, wherein the interspinous spacer device is configured to be moved from a folded delivery arrangement to an unfolded H-shaped arrangement based on operation of the instrument and to be moved from the unfolded H-shaped arrangement to the folded delivery arrangement based on operation of the instrument.

18. The interspinous spacer device of claim 12, wherein the interspinous spacer device is configured to have an unconstrained H-shaped configuration after the instrument has been separated from the interspinous spacer device.

19. The interspinous spacer device of claim 12, wherein the first apexes are configured to remain in the first delivery configuration while being unrestrained by any external device.

20. The interspinous spacer device of claim 12, wherein the port is an inflation port or an injection port.