Systems and methods for posterior dynamic stabilization of the spine

• US 8,425,559 B2
• Filed: 11/07/2006
• Issued: 04/23/2013
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Tebbe, Shawn, Altarac, Moti, Kim, Daniel H.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US11/593,995
• Publication Number:
  US 20070173832A1
• Time in Patent Office: 2,359 Days
• Field of Search: None
• US Class Current: 606/248
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• 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 17/7067 Devices bearing against one or more spinous processes and also attached to another part of the spine; 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 17/848 Kirschner wires, i.e. thin, long nails
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/033 Abutting means, stops, e.g. abutting on tissue or skin
• CPC Class Codes: A61B 2090/034 : abutting on parts of the device itself
• CPC Class Codes: A61B 2090/062 : penetration depth
• CPC Class Codes: A61F 2/0077 : Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

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 including a first vertebra having a first spinous process and a second vertebra having a second spinous process, wherein an interspinous space is defined therebetween, comprising:

a. a body having a proximal end having a feature configured to be releasably attached to an insertion tool and a distal end;

b. a superior U-shaped member having a proximal end rotatably coupled to the body proximate the distal end, a distal end having a first projection, a second projection, and a cross-member between the first and second projections, wherein the first and second projections are spaced apart from each other by a distance such that in a deployed position the first and second projections are configured to be adjacent opposite sides of the superior spinous process, and a tip at the proximal end;

c. an inferior U-shaped member having a proximal end rotatably coupled to the body proximate the distal end, a distal end having a first projection, a second projection, and a cross-member between the first and second projections, wherein the first and second projections are spaced apart from each other by a distance such that in a deployed position the first and second projections are configured to be adjacent opposite sides of the inferior spinous process, and a tip at the proximal end;

d. an actuator shaft disposed within the body, the actuator shaft having a distal end configured such that distal motion of the actuator shaft contacts the tips at the proximal ends of the superior and inferior U-shaped members and causes rotation of the superior and inferior U-shaped members toward the proximal end of the body into the deployed position, and wherein at least one of the cross-members configured to contact an adjacent spinous process in the deployed position.

2. The device of claim 1, further comprising a void defined in the actuator shaft in which is at least partially and slidingly disposed a pin, the pin securedly attached to the body, such that movement of the void relative to the pin secures the superior and inferior U-shaped members in at least one deployment position.

3. The device of claim 2, wherein the actuator shaft further defines at least two fingers that extend into the void, the fingers for frictionally engaging the pin.

4. The device of claim 1, wherein the superior and inferior U-shaped members rotate about 90 degrees from an undeployed to a deployed position.

5. The device of claim 1, wherein the actuator shaft has a distal tip that is in a wedge shape.

6. The device of claim 1, wherein the actuator shaft has a distal tip that is in a fork shape.

7. The device of claim 6, wherein the actuator shaft has a distal tip that is in a split or offset fork shape.

8. The device of claim 1, wherein the proximal end of the body and the proximal end of the actuator shaft are configured to attach to an insertion device.

9. The device of claim 8, wherein the insertion device is structured to attach to the body and the actuator shaft in only one orientation.

10. The device of claim 8, wherein the insertion device is structured to provide relative movement between the body and the actuator shaft.

11. The device of claim 1, wherein each U-shaped member includes a base and the projections are arms connected to the base, wherein at least one pair of projecting arms have the same length.

12. The device of claim 1, wherein each U-shaped member includes a base and the projections are arms connected to the base, wherein at least one pair of projecting arms have different lengths.

13. The device of claim 1, wherein each U-shaped member includes a base and the projections are arms connected to the base, wherein at least one projecting arms includes a hinged portion.

14. The device of claim 1, wherein each U-shaped member includes a base and the projections are arms connected to the base, wherein at least one base includes a flat surface oriented toward the spinous process when implanted.

15. The device of claim 1, wherein each U-shaped member includes base and the projections are arms connected to the base, wherein at least one base includes a rounded surface oriented toward the spinous process when implanted.

16. The device of claim 1, wherein each U-shaped member includes a base and the projections are arms connected to the base, wherein at least one base includes a textured surface configured to grip the spinous process when implanted.

17. The device of claim 1, wherein each U-shaped member includes a base and the projections are arms connected to the base, wherein at least one base includes a resilient member configured to contact the spinous process when implanted.

18. The device of claim 1, wherein said device includes at least one marker configured to provide deployment information.

19. The device of claim 18, wherein the marker is a visible marker.

20. The device of claim 18, wherein the marker is selected from the group consisting of:

radiopaque markers;

ultrasonic markers;

magnetic or electro-magnetic markers; and

combinations thereof.

21. The device of claim 1, wherein at least a portion of said device is modified to reduce or prevent tissue in-growth.

22. The device of claim 21, wherein the modification is selected from the group consisting of:

coatings or embedded supplies of drugs or other agents;

inclusion of a radioactive source;

surface modifications such as surface energy modifications; and

combinations thereof.

23. The device of claim 21, wherein the covering is removable and/or penetrable.

24. The device of claim 1, wherein at least a portion of said device includes a covering configured to provide a contaminant or tissue in-growth barrier.

25. The device of claim 1, further comprising a shape modifying component.

26. The device of claim 25, wherein the shape modifying component modifies its shape during a temperature change.

27. The device of claim 1 wherein:

the body has a longitudinal axis;

the tip at the proximal end of the superior U-shaped member comprises a superior cam;

the tip at the proximal end of the inferior U-shaped member comprises an inferior cam; and

the distal end of the actuator shaft has a first tip configured to contact the superior cam and a second tip configured to contact the inferior cam such that distal movement of the actuator shaft causes the superior and inferior U-shaped members to rotate to a deployed position in which the superior and inferior U-shaped members are transverse to the longitudinal axis of the body.

28. The device of claim 27 wherein the superior U-shaped member and the inferior U-shaped member are hingedly attached to the body.

29. The device of claim 27 wherein the superior U-shaped member member includes a first projection and a second projection spaced apart from each other by a distance configured to receive the first spinous process between the first and second projections.

30. The device of claim 29 wherein the inferior U-shaped member member further includes a first projection and a second projection spaced apart from each other by a distance configured to receive the second spinous process between the first and second projections.

31. The device of claim 27 wherein the actuator shaft further comprises a fork such that the first and second tips of the actuator shift are offset from each other.