Interspinous spacer

• US 8,277,488 B2
• Filed: 07/24/2008
• Issued: 10/02/2012
• 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:
  US12/220,427
• Publication Number:
  US 20080294263A1
• Time in Patent Office: 1,531 Days
• Field of Search: 606/249, 606/248, 623/17.11, 623/17.15, 623/17.16
• US Class Current: 606/249
• 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 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;

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

each arm defining a configuration for receiving a spinous process of a subject;

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;

a shaft connected to the actuator and configured for 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 moves the actuator such that the at least one bearing surface contacts at least one of the caming surfaces to move both of the arms from an undeployed configuration to a deployed configuration in which the arms receive adjacent spinous processes while the body is positioned between the spinous processes such that the longitudinal axis of the body extends in a posterior-anterior direction relative to a spine of the subject.

2. The spacer of claim 1 further including 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.

3. The spacer of claim 2 wherein the retainer includes at least one prong configured to attach to the body.

4. The spacer of claim 1 wherein the spindle includes an inner threaded surface and the shaft includes an outer threaded surface configured for threaded engagement with each other.

5. The spacer of claim 1 further including a lock configured to resist rotation of the spindle.

6. The spacer of claim 1 further including 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.

7. 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.

8. The spacer of claim 7 wherein the apertures and pins are configured such that the first and second arms are capable of rotation with respect to the body.

9. The spacer of claim 7 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.

10. The spacer of claim 7 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.

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

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

13. 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.

14. 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.

15. The spacer of claim 14 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.

16. 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.

17. 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.

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

19. The spacer of claim 1 wherein rotation of the spindle 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 spindle in an opposite direction moves the actuator proximally to permit the arms to fold into at least one undeployed or intermediary configuration.

20. 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.

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

22. 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 other spinous process.

23. 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.

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

25. The spacer of claim 1 wherein the first arm and the second arm extend in a direction substantially parallel to the longitudinal axis of the body when both of the first arm and the second arm are in the undeployed configuration.

26. The spacer of claim 1, wherein the first arm and the second arm rotate away from the longitudinal axis of the body when both of the first arm and the second arm move from the undeployed configuration to the deployed configuration.

27. 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 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;

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

a spindle;

a retainer configured to retain the actuator and the spindle with respect to the body such that the actuator moves and the spindle rotates relative to the body, wherein the retainer includes an opening configured to allow the shaft to pass through;

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 contacts at least one of the caming surfaces to move both of the arms from an undeployed configuration to a deployed configuration in which the arms receive adjacent spinous processes.

28. 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 configuration for receiving a spinous process;

each arm having a proximal caming surface;

an actuator connected to the body and configured to move relative to the body to deploy the arms from an undeployed configuration wherein in the deployed configuration the arms seat adjacent spinous processes and the longitudinal axis of the body is positioned between the adjacent spinous processes and extends in a substantially posterior-anterior direction; and

a lock configured to provide resistance to keep the arms in place.

29. The spacer of claim 28 wherein the lock is configured to provide resistance to the actuator while permitting the actuator relative movement with respect to the body.

30. The spacer of claim 28 further including a spindle threaded to the actuator;

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.

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

32. The spacer of claim 28 wherein the lock is releasable.

33. The spacer of claim 28 further including a spindle connected to the actuator and the lock being configured to provide resistance to the rotation of the spindle.

34. 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 including a substantially U-shaped portion configured to receive and extend on either side of a spinous process;

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 contacts and moves both of the arms from an undeployed configuration to a deployed configuration in which the substantially U-shaped portions of the arms receive and extend on either side of the adjacent spinous processes.

35. The spacer of claim 34 wherein 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.

36. The spacer of claim 34 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.