Interspinous spacer

• US 8,123,782 B2
• Filed: 09/05/2008
• Issued: 02/28/2012
• 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: Altarac, Moti, Tebbe, Shawn, Reglos, Joey Camia, Cheng, Yang
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US12/205,511
• Publication Number:
  US 20080319550A1
• Time in Patent Office: 1,271 Days
• Field of Search: 623/17.15
• US Class Current: 606/249
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

An implantable spacer for placement between adjacent spinous processes is provided. The spacer includes a body and a wing rotatable connected to the body. The wing includes two U-shaped configurations that together define a substantially H-shaped configuration for retaining the spacer between adjacent spinous processes. An actuator assembly is connected to the body and to the wing with the proximal end of the spacer being connectable to a removable driver that is configured to engage the actuator assembly. While connected to the spacer, the driver is rotatable in one direction to deploy the wing from an undeployed to a deployed configuration and in an opposite direction to undeploy the wing. In the deployed configuration, the spacer acts as a space holder opening up the area of the spinal canal, maintaining foraminal height, reducing stress on the facet joints and relieving pain for the patient.

Claims

1. An implantable spacer for placement between adjacent spinous processes, the adjacent spinous processes including a superior spinous process and an inferior spinous process, each of the superior and inferior spinous processes having two lateral surfaces, the implantable spacer comprising:

a body having a longitudinal axis, a first lateral side, and a second lateral side;

a wing connected to the body and capable of movement with respect to the body, the wing comprising a first rotating member at the first lateral side of the body including a first pair of extension members having first longitudinal axes, a second rotating member at the second lateral side of the body including a second pair of extension members having second longitudinal axes, and at least one caming surface;

an actuator assembly connected to the body, the actuator assembly comprising an actuator and a shaft connected to the actuator;

wherein the actuator assembly is configured such that the shaft is accessible at the proximal end of the spacer, and the actuator is configured to move relative to the body to contact the caming surface of the wing to move the wing from a first position for insertion to a second position for stabilizing the spinous processes; and

wherein the first longitudinal axes of the first pair of extension members are coincident with each other in the first and second positions, and the second longitudinal axes of the second pair of extension members are coincident with each other in the first and second positions.

2. The spacer of claim 1 wherein each extension member has an inner surface and an outer surface and when in the second position each inner surface of each extension member faces at least one or more lateral surface.

3. The spacer of claim 2 wherein the inner surface of each extension member faces at least one lateral surface of a superior spinous process.

4. The spacer of claim 3 wherein the inner surface of one extension member of the wing faces a lateral surface of the superior spinous process and the inner surface of the other extension member of the wing faces a lateral surface of the inferior spinous process.

5. The spacer of claim 1 wherein superior portions of the first and second pairs of extension members and a superior surface of the body form a substantially U-shaped configuration for the wing.

6. The spacer of claim 1 wherein when in the first position, the longitudinal axis of each extension member and the longitudinal axis of the body are substantially parallel.

7. The spacer of claim 1 wherein when in the first position, the longitudinal axis of each extension member and the longitudinal axis of the body arc substantially in the same plane.

8. The spacer of claim 1 wherein the first and second longitudinal axes of the first and second extension members are substantially parallel and rotate in a common rotational direction from the first position to the second position.

9. The spacer of claim 1 wherein the first pair of extension members of the first rotating member rotate about a common rotational axis from the first position to the second position, and the second pair of extension members of the second rotating member rotate about the common rotational axis from the first position to the second position.

10. The spacer of claim 1 wherein the two pairs of extension members form a substantially H-shaped configuration for the wing.

11. The spacer of claim 1 wherein when in the second position, the inner surface of one extension member of the first pair faces a lateral surface of the superior spinous process and the inner surface of one extension member of the second pair faces the other lateral surface of the superior spinous process, and the inner surface of the other extension member of the first pair faces a lateral surface of the inferior spinous process and the inner surface of the other extension member of the second pair faces the other lateral surface of the inferior spinous process.

12. The spacer of claim 1 wherein the wing includes a second caming surface.

13. The spacer of claim 12 wherein the actuator includes a first surface for bearing against the first caming surface for moving the wing from a first position to a second configuration and a second surface for bearing against the second caming surface when in the second position.

14. The spacer of claim 13 wherein the first surface and second surface of the actuator define a wedge-shaped space for receiving the first caming surface and second caming surface of the wing.

15. The spacer of claim 1 wherein the wing includes a second caming surface angled with respect to the first caming surface.

16. The spacer of claim 1 wherein the actuator includes a first surface for bearing against the first caming surface to move the wing from the first position to the second position.

17. The spacer of claim 1 wherein the shaft is threadingly connected to the body.

18. The spacer of claim 17 wherein the shaft is threadingly connected to the body via a body link.

19. The spacer of claim 1 wherein the actuator defines a wedge-shaped space for receiving the caming surface of the wing.

20. The spacer of claim 1 wherein the actuator includes an enlarged distal end.

21. An implantable spacer for placement between adjacent spinous processes, the adjacent spinous processes including a superior spinous process and an inferior spinous process, each of the superior and inferior spinous processes having two lateral surfaces, the implantable spacer comprising:

a body having a first lateral portion, a second lateral portion, a superior surface configured to contact the superior spinous process, and an inferior surface configured to contact the inferior spinous process;

a wing assembly having a first rotating member at the first lateral portion and a second rotating member at the second lateral portion, wherein the first rotating member has a first superior extension member and a first inferior extension member extending coincidentally along a first common axis in an undeployed state, and the second rotating member has a second superior extension member and a second inferior extension member extending coincidentally along a second common axis in the undeployed state; and

an actuator coupled to the body, the actuator being configured to rotate the first and second rotating members such that the first superior and first inferior extension members rotate together in a common rotational direction and the second superior and second inferior extension members rotate together in the common rotational direction from the undeployed state to a deployed state.

22. The implantable spacer of claim 21, wherein the first superior extension member and the first inferior extension member are fixed relative to each other and extend coincidentally along the first common axis in the deployed state, and the second superior extension member and the second inferior extension member are fixed relative to each other and extend coincidentally along the second common axis in the deployed state.

23. The implantable spacer of claim 22, wherein the first superior extension member and the first inferior extension member are integral with each other, and the second superior extension member and the second inferior extension member are integral with each other.

24. The implantable spacer of claim 23, wherein, in the deployed state, the first superior extension member extends superiorly with respect to the body and the first inferior extension member extends inferiorly with respect to the body, and the second superior extension member extends superiorly with respect to the body and the second inferior extension member extends inferiorly with respect to the body at the second lateral portion.