Interspinous spacer

• US 9,161,783 B2
• Filed: 09/14/2012
• Issued: 10/20/2015
• 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): Prone, Christopher D
• Application Number:
  US13/619,195
• Publication Number:
  US 20130172932A1
• Time in Patent Office: 1,131 Days
• Field of Search: 623/17.11, 623/17.15, 623/17.16, 606246-249
• US Class Current: 1/1
• 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: 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 earning 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 earning 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;

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

each arm being configured to receive a spinous process and having a proximal bearing surface;

an actuator assembly connected to the body;

the actuator assembly comprising;

an actuator having at least one bearing surface;

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

a spindle;

the actuator assembly is configured to move relative to the body such that rotation of the spindle relative to the shaft causes linear movement of the actuator with respect to the body such that the at least one bearing surface of the actuator contacts at least one of the bearing surfaces of the arms to move both of the arms from an undeployed configuration to a deployed configuration in which the arms receive adjacent spinous processes.

2. 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 at the pins such that the arms are movable with respect to the body.

3. The spacer of claim 2 wherein the apertures and pins are configured such that the first and second arms are capable of rotation with respect to the body.

4. The spacer of claim 2 wherein the apertures and pins are configured such that the first and second arms are capable of rotation and translation with respect to the body.

5. The spacer of claim 2 wherein the apertures and pins are configured such that the first and second arms are capable of rotation followed by translation with respect to the body.

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

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

8. The spacer of claim 1 wherein the first and second arms are configured such that the first and second arms are capable of outwardly extending away from 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 the undeployed configuration in which the arms are substantially parallel to the longitudinal axis of the body.

10. The spacer of claim 9 wherein at least one of the first and second arms extend outwardly with respect to the body in a direction substantially transverse to the longitudinal axis of the body.

11. 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.

12. The spacer of claim 1 wherein the body is 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.

13. The spacer of claim 1 wherein the spindle includes notches for receiving a tool to rotate to the spindle with respect to the body.

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

15. 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.

16. The spacer of claim 1 wherein the body defines a passageway and the actuator assembly is at least partially disposed inside the passageway.

17. The spacer of claim 1 wherein each of the first and second arms includes elongated extensions and a saddle between the elongated extensions that together define a U-shaped configuration.

18. The spacer of claim 1 wherein each of the first and second arms includes elongated extensions spaced apart to receive one of the spinous processes therebetween.

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

a body defining a longitudinal axis;

a first arm and a second arm both connected to the body and capable of movement with respect to the body, each arm having a proximal bearing surface;

an actuator assembly connected to the body, the actuator assembly comprising;

an actuator having at least one bearing surface;

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

a spindle;

wherein the actuator assembly is configured to move relative to the body such that rotation of the spindle moves the actuator such that the at least one bearing surface of the actuator contacts at least one of the bearing surfaces of the arms to move both of the arms from an undeployed configuration to a deployed configuration in which the first and second arms receive adjacent spinous processes; and

a retainer configured to retain the actuator and spindle with respect to the body such that the actuator moves and the spindle rotates relative to the body.

20. The spacer of claim 19 wherein the retainer includes at least one prong configured to attach to the body.

21. The spacer of claim 19 wherein the retainer includes an opening configured to allow the shaft to pass through.

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

a body defining a longitudinal axis;

a first arm and a second arm both connected to the body and capable of movement with respect to the body, each arm having a proximal bearing surface;

an actuator assembly connected to the body, the actuator assembly comprising;

an actuator having at least one bearing surface;

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

a spindle including an inner threaded surface, wherein the shaft includes an outer threaded surface configured for threaded engagement with the inner threaded surface of the spindle; and

wherein the actuator assembly is configured to move relative to the body such that rotation of the spindle moves the actuator such that the at least one bearing surface of the actuator contacts at least one of the bearing surfaces of the arms to move both of the arms from an undeployed configuration to a deployed configuration in which the first and second arms receive adjacent spinous processes.

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

a body defining a longitudinal axis;

a first arm and a second arm both connected to the body and capable of movement with respect to the body, each arm having a proximal bearing surface;

an actuator assembly connected to the body, the actuator assembly comprising;

an actuator having at least one bearing surface;

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

a spindle;

wherein the actuator assembly is configured to move relative to the body such that rotation of the spindle moves the actuator such that the at least one bearing surface of the actuator contacts at least one of the bearing surfaces of the arms to move both of the arms from an undeployed configuration to a deployed configuration in which the first and second arms receive adjacent spinous processes; and

a lock configured to resist rotation of the spindle.

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

a body defining a longitudinal axis;

a first arm and a second arm both connected to the body and capable of movement with respect to the body, each arm configured to receive a spinous process, each arm having a proximal bearing surface;

an actuator assembly connected to the body, the actuator assembly comprising;

an actuator having at least one bearing surface;

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

a spindle;

wherein the actuator assembly is configured to move relative to the body such that rotation of the spindle moves the actuator such that the at least one bearing surface of actuator contacts at least one of the bearing surfaces of the arms to move both of the arms from an undeployed configuration to a deployed configuration in which the arms receive adjacent spinous processes; and

a lock having at least one tooth and the spindle further including a plurality of teeth on the other surface configured to engage the at least one tooth on the lock.

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

a body defining a longitudinal axis;

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

each arm configured to receive a spinous process;

each arm having a proximal bearing surface;

a spindle;

an actuator connected to the body such that rotation of the spindle causes the actuator to move relative to the body to deploy the first and second arms from an undeployed configuration to a deployed configuration to seat adjacent spinous processes in the first and second arms; and

a lock in an unlocked position is configured to allow the spindle to rotate relative to the lock to deploy the first and second arms, and the lock in a locked position is configured to provide resistance to rotation of the spindle relative to the lock so as to keep the first and second arms in place.

26. The spacer of claim 25 wherein the lock is configured to provide resistance to the actuator while permitting the actuator relative movement with respect to the body.

27. The spacer of claim 25, further including

a shaft connected to the actuator;

and

a spindle threaded to the shaft;

wherein the spindle includes an outer surface having a plurality of teeth and the lock includes at least one tooth configured to engage the plurality.

28. The spacer of claim 25 wherein the lock is configured to retain the actuator in place.

29. The spacer of claim 25 wherein the lock is releasable.

30. The spacer of claim 25 wherein the spindle is threadably connected to the actuator and the lock is configured to provide resistance to the rotation of the spindle.

31. The spacer of claim 25 wherein each of the first and second arms has a U-shaped portion configured to receive one of the spinous processes such that the spinous process is located between elongate extensions of the U-shaped portion.

32. A spinal implant for relieving pain implantable between a superior spinous process and an inferior spinous process comprising:

a body connected prior to implantation to at least one arm; and

an actuator assembly with an actuator and a spindle, wherein the actuator is configured to translate through the body to cause the at least one arm to move with respect to the body and into at least one configuration when the spindle rotates relative to the actuator and the body, wherein the at least one arm in the at least one configuration is adapted to laterally stabilize the body with respect to an adjacent spinous process.

33. The spinal implant of claim 32 wherein the at least one arm is configured to receive a spinous process.

34. The spinal implant of claim 32 wherein the at least one arm is substantially U-shaped.

35. The spinal implant of claim 32 wherein the at least one arm includes a first arm for laterally stabilizing the body with respect to the superior spinous process and a second arm for laterally stabilizing the body with respect to the inferior spinous process.

36. The spinal implant of claim 35 wherein at least one of the first and second arms is configured for receiving at least one of the superior and inferior spinous processes.

37. The spinal implant of claim 35 wherein each of the first and second arms are substantially U-shaped.

38. The spinal implant of claim 32 wherein the at least one arm includes a first arm and a second arm for laterally stabilizing the body with respect to the adjacent spinous processes.

39. The spinal implant of claim 38 wherein the implant includes a collapsed configuration in which a first end of the first arm and a first end of the second arm form the leading edge of the implant.

40. The spinal implant of claim 38 wherein a second end of the first arm is hinged to the distal end of the body and a second end of the second arm is hinged to the distal end of the body.

41. The spinal implant of claim 40 wherein the first and second arms are configured to rotate approximately 90 degrees about their hinged ends.

42. The spinal implant of claim 41 wherein when rotated 90 degrees, the first and second arms are in a configuration that is adapted to laterally stabilize the body with respect to adjacent spinous processes.

43. The spinal implant of claim 42 wherein after rotation of 90 degrees, the first and second arms are configured to translate away from the body such that the arms are closer to their respective spinous processes.

44. The spinal implant of claim 32 wherein the actuator is accessed at the proximal end of the body for moving the arms located at the distal end of the body.