Interspinous spacer

• US 8,292,922 B2
• Filed: 04/16/2008
• Issued: 10/23/2012
• 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
• Primary Examiner(s): Stewart, Alvin
• Assistant Examiner(s): PALMER, JAMES W
• Application Number:
  US12/148,104
• Publication Number:
  US 20080195152A1
• Time in Patent Office: 1,651 Days
• Field of Search: 606248-249
• 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 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

A novel implantable spacer for placement between adjacent spinous processes in a spinal motion segment is provided. The spacer includes a body defining a longitudinal passageway. A first arm and a second arm are connected to the body. Each arm has a pair of extensions and a saddle defining a U-shaped configuration for seating a spinous process therein. Each arm has a proximal camming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the longitudinal passageway and connected to the body. When advanced, the actuator assembly contacts the camming surfaces of the arms to rotate them from an undeployed configuration to a deployed configuration. In the deployed configuration, the distracted adjacent spinous processes are seated in the U-shaped portion of the arms providing sufficient distraction to open the neural foramen to relieve pain. An insertion instrument is provided for implanting the interspinous process spacer. The system is configured for quick implantation through a small percutaneous incision employing minimally invasive techniques.

Claims

1. An implantable spacer for placement between adjacent interspinous processes in a spinal motion segment comprising:

a body defining a longitudinal passageway and a longitudinal axis;

a first arm and a second arm connected to the body and capable of rotation with respect to the body;

each arm having a pair of extensions spaced apart from one another to define an opening between the extensions, the opening being configured to receive a spinous process;

each arm having a proximal camming surface;

an actuator assembly connected to the body;

the actuator assembly comprising an actuator having a proximal end and a distal end;

the actuator having at least one bearing surface at the distal end configured to engage each camming surface;

the actuator is connected to the body and configured to move inside the longitudinal passageway relative to the body to contact each camming surface with the at least one bearing surface and thereby move the arms from an undeployed configuration in which the arms are substantially parallel to the longitudinal axis of the body to a deployed configuration in which the arms are substantially perpendicular to the longitudinal axis of the body to contain adjacent spinous processes in each arm when in the deployed configuration.

2. The spacer of claim 1 wherein the arms are configured to rotate with respect to the body in moving from an undeployed configuration to a deployed configuration.

3. The spacer of claim 1 wherein the arms are configured to rotate with respect to the body about a single axis in moving from an undeployed configuration to a deployed configuration.

4. The spacer of claim 1 wherein each arm is configured to rotate with respect to the body about separate axes.

5. The spacer of claim 1 wherein the arms are configured to rotate with respect to the body in moving from an undeployed configuration to a first deployed configuration and then translate with respect to the body in moving from the first deployed configuration to a second deployed configuration.

6. The spacer of claim 5 wherein the rotation is approximate 90 degrees from the undeployed configuration to the first deployed configuration.

7. The spacer of claim 5 wherein each arm is configured to rotate outwardly into a planar space that is substantially transverse to the longitudinal axis;

and each arm is configured to translate in said plane away from the longitudinal axis in moving from the first deployed configuration to a second deployed configuration.

8. The spacer of claim 1 wherein the actuator includes two bearing surfaces that converge towards the distal end of the actuator.

9. The spacer of claim 1 wherein the actuator includes two bearing surfaces that diverge towards the distal end of the actuator.

10. The spacer of claim 1 wherein the proximal end of the actuator is configured for attachment to an instrument for moving the actuator with respect to the body.

11. The spacer of claim 1 wherein the first arm is configured to contain a superior spinous process and the second arm is configured to contain an inferior spinous process.

12. The spacer of claim 1 wherein the first arm is configured to contain one side of the superior and inferior spinous processes and the second arm is configured to contain the other side of the superior and inferior spinous processes.

13. The spacer of claim 1 wherein the body includes at least one longitudinal scallop extending along at least a portion of the body;

the scallop is configured to provide a lower profile for the spacer for insertion between adjacent interspinous processes along a posterior midline approach while in the undeployed configuration relative to the at least one deployed configuration.

14. The spacer of claim 1 wherein

each of the extensions of the first arm is a first elongate member, the first elongate members are configured to be positioned on opposite sides of a first spinous process when the first spinous process is positioned in and extends posteriorly from the opening of the first arm;

and

each of the extensions of the second arm is a second elongate member, the second elongate members are configured to be positioned on opposite sides of a second spinous process when the second spinous process is positioned in and extends posteriorly from the opening of the second arm.

15. The spacer of claim 1 wherein the body is positioned relative to the first arm and the second arm such that the longitudinal axis extends in a posterior-anterior direction when a first spinous process is positioned in the opening between the extensions of the first arm and when a second spinous process is positioned in the opening between the extensions of the second arm.

16. The spacer of claim 1 wherein terminal ends of the extensions of the first arm are spaced apart from one another such that the terminal ends are positioned on opposite lateral sides of a superior spinous process positioned in the opening between the extensions of the first arm.

17. An implantable spacer for placement between adjacent interspinous processes in a spinal motion segment comprising:

a body defining a longitudinal passageway and a longitudinal axis;

a first arm and a second arm connected to the body and capable of rotation with respect to the body;

each arm having a pair of extensions and configured for containing a spinous process therein;

each arm having a proximal camming surface;

an actuator assembly connected to the body;

the actuator assembly comprising an actuator having a proximal end and a distal end;

the actuator having at least one bearing surface at the distal end configured to engage each camming surface;

the actuator is connected to the body and configured to move inside the longitudinal passageway relative to the body to contact each camming surface with the at least one bearing surface and thereby move the arms from an undeployed configuration in which the arms are substantially parallel to the longitudinal axis of the body to a deployed configuration in which the arms are substantially perpendicular to the longitudinal axis of the body to contain adjacent spinous processes in each arm when in the deployed configuration, wherein the actuator includes an elongate slot and the actuator is connected to the body with a pin passed through the slot and connected to the body such that the actuator is configured to move longitudinally with respect to the body.

18. The spacer of claim 17 wherein the elongate slot includes at least one constriction configured to lock the pin with respect to the actuator when the arms are positioned in at least one deployed configuration.

19. An implantable spacer for placement between adjacent interspinous processes in a spinal motion segment, comprising:

a body having a proximal portion, a distal portion and a posterior-anterior dimension between the proximal and distal portions;

a first arm having a pair of first extensions, a first cross-member between the first extensions, and a first proximal camming surface, wherein the first extensions are spaced apart from one another to define a first opening between the first extensions, the first opening being configured to receive a first spinous process;

a second arm having a pair of second extensions, a second cross-member between the second extensions, and a second proximal camming surface, wherein the second extensions are spaced apart from one another to define a second opening between the second extensions, the second opening being configured to receive a second spinous process;

a hinge assembly rotatably coupling the first and second arms to the distal portion of the body, wherein the hinge assembly has at least a first pin extending transverse to the posterior-anterior dimension to define a first rotation axis about which the first arm can rotate; and

an actuator assembly coupled to the body to move along the posterior-anterior dimension, the actuator assembly having an actuator including a proximal end, a distal end, a first bearing surface at the distal end, and a second bearing surface at the distal end, wherein the first bearing surface is configured to contact the first camming surface of the first arm and the second bearing surface is configured to contact the second camming surface of the second arm as the actuator moves distally thereby causing the first arm to rotate about the first rotation axis from an undeployed configuration to a deployed configuration.

20. The spacer of claim 19 wherein the first and second pairs of extensions are configured to extend distally at least substantially parallel to the posterior-anterior dimension in the undeployed configuration and rotate proximally to be at least substantially perpendicular to the posterior-anterior dimension in the deployed configuration.

21. The spacer of claim 19 wherein the first and second bearing surfaces of the actuator converge towards the distal end.

22. The spacer of claim 19 wherein the second arm is configured to rotate about the first axis.

23. The spacer of claim 19 wherein the hinge assembly further comprises a second pin extending transverse to the posterior-anterior dimension to define a second rotation axis spaced apart from the first rotation axis, and wherein the actuator is configured to cause the first arm to rotate about the first rotation axis and the second arm to rotate about the second rotation axis from an undeployed configuration to a deployed configuration as the actuator moves distally.

24. The spacer of claim 23 wherein the actuator is configured to rotate the first and second arms at least substantially concurrently.

25. The spacer of claim 19 wherein each of the first extensions is an elongate member, the elongate members of the first arm are configured to be positioned on opposing lateral sides of a first spinous process when the first spinous process extends through and posteriorly from the first opening of the first arm.

26. An implantable interspinous spacer, comprising:

a body defining a longitudinal passageway and a longitudinal axis;

a first arm coupled to the body and rotatable relative to the body, the first arm including a pair of first extension members spaced apart to define a first opening configured to receive a superior spinous process such that the superior spinous process extends in a posterior-anterior direction through the first opening when the first extension members are positioned on opposing laterals sides of the superior spinous process;

a second arm coupled to the body and rotatable relative to the body, the second arm including a pair of second extension members spaced apart to define a second opening configured to receive an inferior spinous process such that the inferior spinous process extends in the posterior-anterior direction through the second opening when the second extension members are positioned on opposing laterals sides of the inferior spinous process; and

an actuator assembly connected to the body, the actuator assembly comprising an actuator having a proximal end and a distal end, the actuator having at least one bearing surface at the distal end configured to engage each camming surface, the actuator being connected to the body and configured to move inside the longitudinal passageway relative to the body to contact each camming surface with the at least one bearing surface to move the first and second arms from an undeployed configuration in which the arms are substantially parallel to the longitudinal axis of the body to a deployed configuration in which the first and second arms are substantially perpendicular to the longitudinal axis of the body.

27. The spacer of claim 26 wherein a portion of the first arm that defines the first opening is sustantially U-shaped and a portion of the second arm that defines the second opening is sustantially U-shaped.

28. The spacer of claim 26 wherein the body is positioned relative to the first arm and the second arm such that the longitudinal axis extends in the posterior-anterior direction when the superior spinous process is positioned in the first opening and the inferior spinous process is positioned in the second opening.

29. The spacer of claim 26 wherein terminal ends of the first extension members are spaced apart from one another such that the terminal ends are positioned on opposing lateral sides of the superior spinous process when the superior spinous process is positioned in the first opening.