Interspinous spacer

• US 8,273,108 B2
• Filed: 07/08/2008
• Issued: 09/25/2012
• 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, Kadaba, Murali P., Kim, Daniel H.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Prone, Christopher D
• Application Number:
  US12/217,662
• Publication Number:
  US 20080287997A1
• Time in Patent Office: 1,540 Days
• Field of Search: 623/17.15
• US Class Current: 606/249
• CPC Class Codes: A61B 17/3421 Cannulas
• 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 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: A61B 2090/034 abutting on parts of the device itself
• 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 in a spinal motion segment is provided. The spacer includes a body defining a longitudinal axis and 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 caming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the passageway and connected to the body. When advanced, a threaded shaft of the actuator assembly contacts the caming surfaces of 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.

Claims

1. An implantable spacer for placement between adjacent spinous processes comprising:

a body defining a longitudinal axis and passageway through at least a portion of the body;

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

each arm defining a configuration for receiving a spinous process;

each arm having a proximal caming surface;

an actuator assembly connected to the body;

the actuator assembly comprising;

an actuator having at least one bearing surface; and

a threaded shaft connected to the actuator and configured for movement with respect to the body;

the actuator assembly is configured such that the actuator is disposed inside the body and configured to move relative to the body such that the at least one bearing surface contacts the caming surfaces of the arms to thereby rotate 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;

wherein, when the body is positioned between the spinous processes such that the longitudinal axis of the body extends in a posterior-anterior direction relative to the spine, the arms receive and seat the adjacent spinous processes when the first and second arms are in the deployed configuration.

2. The spacer of claim 1 further including a retainer configured to retain the actuator inside the body.

3. The spacer of claim 1 wherein each of the first and second arms includes at least one pin and the body includes corresponding apertures configured for connecting the first and second arms to the body such that the arms are movable with respect to the body.

4. The spacer of claim 3 wherein the apertures and pins are configured such that the first and second arms are capable of rotation and subsequent translation with respect to the body.

5. The spacer of claim 1 wherein the first and second arms are configured for rotation and translation with respect to the body.

6. The spacer of claim 1 wherein the apertures are configured such that the first and second arms are capable of outwardly extending away from the body.

7. The spacer of claim 1 wherein the first and second arms rotate approximately 90 degrees into at least one deployed configuration in which the arms are approximately transverse to the longitudinal axis of the body;

said rotation being from an undeployed configuration in which the arms are substantially parallel to the longitudinal axis of the body.

8. The spacer of claim 7 wherein at least one of the first and second arms extend outwardly with respect to the body in a direction substantially transverse to longitudinal axis of the body.

9. The spacer of claim 1 wherein the first and second arms rotate approximately 90 degrees into at least one deployed configuration in which the arms are approximately transverse to the longitudinal axis of the body;

said rotation being from an undeployed configuration in which the arms are substantially parallel to the longitudinal axis of the body; and

wherein following said rotation upon further actuation the arms translate with respect to the body in a direction substantially transverse to longitudinal axis of the body.

10. The spacer of claim 1 wherein the passageway includes an inner threaded surface configured for threaded engagement with the threaded shaft.

11. The spacer of claim 1 wherein the body includes notches configured for attachment to a spacer delivery instrument such that the longitudinal axis of the spacer delivery instrument is substantially aligned with the longitudinal axis of the spacer.

12. The spacer of claim 1 wherein the threaded shaft includes a socket at the proximal end for receiving a tool to rotate to the shaft with respect to the body and deploy the arms.

13. The spacer of claim 1 wherein rotation of the threaded shaft in one direction advances the actuator distally to engage the caming surfaces and deploy the arms into at least one deployed configuration and rotation of the threaded shaft in an opposite direction moves the actuator proximally to permit the arms to fold into at least one undeployed or intermediary configuration.

14. The spacer of claim 1 wherein each arm has a pair of extensions and a saddle defining a configuration that is substantially U-shaped for seating a spinous process.

15. The spacer of claim 1 wherein each arm has a substantially U-shaped portion, the substantially U-shaped portion of the first arm has a pair of elongate members with free ends configured to be positioned on either side of one of the spinous processes and the substantially U-shaped portion of the second arm has a pair of elongate members with free ends configured to be positioned on either side of the adjacent spinous process.

16. The spacer of claim 1 wherein the actuator assembly is connected to the body such that the actuator is moveable along the passageway of the body towards the proximal caming surfaces when the threaded shaft is rotated relative to the body.

17. The spacer of claim 1 wherein the actuator is moveable along the passageway of the body towards and between the proximal caming surfaces, and wherein the proximal caming surfaces face one other and are positioned on opposite sides of the longitudinal axis of the body.

18. The spacer of claim 1 wherein each arm has a substantially U-shaped portion, and wherein the first arm and the second arm are configured to hold the body spaced apart from both of the spinous processes when the substantially U-shaped portion of the first arm receives and seats one of the spinous processes and the substantially U-shaped portion of the second arm receives and seats the adjacent spinous process.

19. An implantable spacer for placement between adjacent spinous processes comprising:

a body defining a longitudinal axis and passageway through at least a portion of the body;

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

each arm defining a configuration for receiving a spinous process;

each arm having a proximal caming surface;

an actuator assembly connected to the body;

the actuator assembly comprising;

an actuator having at least one bearing surface; and

a threaded shaft connected to the actuator and configured for movement with respect to the body; and

a retainer configured to retain the actuator inside the body, wherein the retainer includes an inner threaded surface configured for threaded engagement with the threaded shaft;

wherein the actuator assembly is configured such that the actuator is disposed inside the body and configured to move relative to the body such that the at least one bearing surface contacts the caming surfaces of the arms to thereby rotate 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;

wherein the arms seat adjacent spinous processes when in the deployed configuration.

20. An implantable spacer for placement between adjacent spinous processes comprising:

a body defining a longitudinal axis and passageway through at least a portion of the body;

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

each arm defining a configuration for receiving a spinous process;

each arm having a proximal caming surface;

an actuator assembly connected to the body;

the actuator assembly comprising;

an actuator having at least one bearing surface; and

a threaded shaft connected to the actuator and configured for movement with respect to the body; and

a retainer configured to retain the actuator inside the body, wherein the retainer includes two prongs with inner threaded surfaces configured to receive the threaded shaft;

wherein the actuator assembly is configured such that the actuator is disposed inside the body and configured to move relative to the body such that the at least one bearing surface contacts the caming surfaces of the arms to thereby rotate 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;

wherein the arms seat adjacent spinous processes when in the deployed configuration a retainer configured to retain the actuator inside the body.

21. The spacer of claim 20 wherein at least one prong is split.

22. The spacer of claim 20 wherein a clearance is defined between each prong such that the actuator is passable through the clearance.

23. The spacer of claim 20 wherein the two prongs are connected at their proximal ends to a circular proximal end.

24. The spacer of claim 23 wherein the two prongs are flexible with respect to the circular proximal end.

25. The spacer of claim 23 wherein the circular proximal end is configured for attachment to the body such that the actuator and threaded shaft is movably connected with respect to the body.

26. An implantable spacer for placement between adjacent spinous processes comprising:

a body defining a longitudinal axis and passageway through at least a portion of the body;

at least a first arm connected to the body and capable of movement with respect to the body and configured for receiving a spinous process; and

an actuator connected to the body, disposed inside the longitudinal passageway and configured to move relative to the body to deploy the at least first arm from an undeployed configuration in which the first arm is substantially parallel to the longitudinal axis of the body to at least one deployed configuration in which the first arm is substantially perpendicular to the longitudinal axis of the body;

wherein the first arm receives a spinous process such that the longitudinal axis of the body is positioned between the adjacent spinous processes and extends in a substantially posterior-anterior direction when the first arm is in the at least one deployed configuration.

27. The spacer of claim 26 wherein the at least first arm includes a proximal caming surface and the actuator includes at least one bearing surface and configured such that the at least one bearing surface contacts the caming surface of the first arm to thereby rotate the first arm into at least one deployed configuration.

28. The spacer of claim 26 further including a second arm connected to the body and capable of movement with respect to the body;

the second arm having a configuration for receiving a spinous process;

the actuator being configured to deploy the second arm from an undeployed configuration in which the second arm is substantially parallel to the longitudinal axis of the body to at least one deployed configuration in which the second arm is substantially perpendicular to the longitudinal axis of the body;

wherein the second arm receives a spinous process when in the at least one deployed configuration.

29. The spacer of claim 28 wherein the at least first and second arms include a proximal bearing surface and the actuator includes at least one bearing surface and configured such that the at least one bearing surface contacts the bearing surfaces of the first and second arms to thereby rotate the first and second arms into at least a one deployed configuration.

30. An implantable spacer for placement between adjacent spinous processes comprising:

a body defining a longitudinal axis and passageway through at least a portion of the body;

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

each arm having a pair of extensions and a saddle defining a configuration for seating a spinous process therein;

each arm having a proximal bearing surface;

an actuator connected to the body and configured to move relative to the body to deploy 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;

wherein the arms seat adjacent spinous processes such that the longitudinal axis of the body is positioned between the adjacent spinous processes and extends in a substantially posterior-anterior direction when the first and second arms are in the deployed configuration; and

a retainer configured to retain the actuator inside the body while permitting the actuator relative movement with respect to the body.

31. The spacer of claim 30 wherein the actuator is threaded to the body.

32. The spacer of claim 30 wherein the actuator includes an outer threaded surface and the retainer includes an inner threaded surface configured for threaded engagement with the threaded actuator.

33. An implantable spacer for placement between a superior spinous process and an adjacent inferior spinous process comprising:

a body defining a longitudinal axis and passageway through at least a portion of the body;

at least a first arm connected to the body and capable of movement with respect to the body;

the first arm having a configuration for seating the superior spinous process;

an actuator connected to the body, disposed inside the longitudinal passageway and configured to move relative to the body to deploy the at least first arm from an undeployed configuration in which the first arm is substantially parallel to the longitudinal axis of the body to at least one deployed configuration in which the first arm is substantially perpendicular to the longitudinal axis of the body;

wherein the first arm seats the superior spinous process such that the longitudinal axis of the body is positioned between the superior spinous process and, the adjacent inferior spinous process and extends in a substantially posterior-anterior direction when the first arm is in the at least one deployed configuration.

34. The spacer of claim 33 wherein the first arm includes a concavity for conforming to the superior spinous process.

35. The spacer of claim 34 wherein the concavity is formed in the anterior face when viewed in the at least one deployed configuration of the first arm.

36. The spacer of claim 33 further including a second arm connected to the body and capable of movement with respect to the body;

the second arm having a configuration for seating the inferior spinous process;

the actuator being configured to deploy the second arm from an undeployed configuration in which the second arm is substantially parallel to the longitudinal axis of the body to at least one deployed configuration in which the second arm is substantially perpendicular to the longitudinal axis of the body;

wherein the second arm seats the inferior spinous process when in the at least one deployed configuration.

37. The spacer of claim 36 wherein the second arm includes a convexity for conforming to the inferior spinous process;

the convexity being formed in the anterior face when viewed in the at least one deployed configuration of the second arm.

38. The spacer of claim 37 wherein the convexity is formed in the anterior face when viewed in the at least one deployed configuration of the second arm.

39. An implantable spacer for placement between adjacent spinous processes comprising:

a body defining a longitudinal axis;

a first arm pivotally connected to the body and capable of movement with respect to the body, wherein the first arm is configured to receive a first spinous process;

a second arm pivotally connected to the body and capable of movement with respect to the body, wherein the second arm is configured to receive a second spinous process; and

an actuator coupled to the body and configured to move relative to the body to deploy the first arm and the second arm from an undeployed configuration to at least one deployed configuration in which the first arm receives the first spinous process and the second arm receives the second spinous process such that the longitudinal axis of the body is positioned between the first and second spinous processes and extends in a substantially posterior-anterior direction.

40. The spacer of claim 39 wherein each arm has a substantially U-shaped portion, the substantially U-shaped portion of the first arm has a pair of elongate members with free ends configured to be positioned on either side of the first spinous process, and the substantially U-shaped portion of the second arm has a pair of elongate members with free ends configured to be positioned on either side of the second spinous process.

41. The spacer of claim 39 wherein the first arm and the second arm are configured to keep the body spaced apart from both of the first spinous process and the second spinous process when the first arm and the second arm are in the deployed configuration.