Interspinous spacer

• US 9,155,570 B2
• Filed: 09/14/2012
• Issued: 10/13/2015
• 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:
  US13/617,018
• Publication Number:
  US 20130172933A1
• Time in Patent Office: 1,124 Days
• Field of Search: 623/17.11, 623/17.15, 606246-249
• US Class Current: 1/1
• 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 being configured to receive a spinous process and rotatable about an axis of rotation relative 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; 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 of the actuator contacts the bearing surfaces of the arms and moves directly between the axes of rotation 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.

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

3. The spacer of claim 2 wherein the retainer includes an inner threaded surface configured for threaded engagement with the threaded shaft.

4. 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.

5. The spacer of claim 4 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.

6. The spacer of claim 4 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 are configured for rotation and translation with respect to the body.

8. 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.

9. The spacer of claim 8 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.

10. 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.

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

12. 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.

13. 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.

14. The spacer of claim 1 wherein rotation of the threaded shaft in one direction advances the actuator distally to engage the bearing surfaces of the arms 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.

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

16. The spacer of claim 1 wherein the arms are configured to seat the adjacent spinous processes when the longitudinal axis of the body is substantially parallel with a sagittal plane of a subject.

17. The spacer of claim 1 wherein the axes of rotation about which the arms rotate are substantially perpendicular to a sagittal plane of a patient when the adjacent spinous processes are seated in the arms.

18. The spacer of claim 1, further comprising an actuator retainer having internal threads for engaging the threaded shaft such that rotation of the retainer relative to the body causes translation of the actuator relative to the body.

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 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, and

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

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 of the actuator contacts the bearing 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; 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.

20. The spacer of claim 19 wherein at least one prong is split.

21. The spacer of claim 19 wherein a clearance is defined between each prong such that the actuator is passable through the clearance.

22. The spacer of claim 19 wherein the two prongs are connected at their proximal ends to a circular proximal end.

23. The spacer of claim 22 wherein the two prongs are flexible with respect to the circular proximal end.

24. The spacer of claim 22 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.

25. 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 including a proximal bearing surface and a pair of elongated members, wherein the at least the first arm is capable of rotation about a first axis of rotation with respect to the body such that the first axis of rotation is between the elongated members and the proximal bearing surface, and wherein the at least the first arm is 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 contact the proximal bearing surface 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 when in the at least one deployed configuration.

26. The spacer of claim 25 wherein the actuator includes at least one bearing surface and is configured such that the at least one bearing surface of the actuator contacts the bearing surface of the first arm to thereby rotate the first arm into at least one deployed configuration.

27. The spacer of claim 25, further including a second arm connected to the body and capable of movement with respect to the body;

the second arm being configured to receive 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.

28. The spacer of claim 27 wherein the second arm includes a proximal bearing surface, wherein the actuator includes at least one bearing surface and is configured such that the at least one bearing surface of the actuator contacts the proximal bearing surfaces of the first and second arms to thereby rotate the first and second arms into at least a one deployed configuration.

29. The spacer of claim 25, further comprising a retainer having internal threads for engaging the actuator such that rotation of the retainer about the longitudinal axis of the body causes translation of the actuator along the passageway.

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, each arm having a pair of extensions and a saddle and being capable of rotation with respect to the body such that the extensions and the saddle rotate relative to the body to seat a spinous process between the extensions, 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 when 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. The spacer of claim 30, wherein the retainer includes internal threads for engaging the actuator such that rotation of the retainer about the longitudinal axis of the body causes movement of the actuator along the passageway.

34. An implantable spacer for placement between a superior spinous process and an adjacent inferior spinous process of a subject, the implantable spacer 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 configured to seat 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 is configured to seat the superior spinous process when the first arm is in the at least one deployed configuration and the longitudinal axis of the body is substantially parallel to a sagittal plane of the subject.

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

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

37. The spacer of claim 34 further including a second arm connected to the body and capable of movement with respect to the body;

the second arm being configured to seat 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.

38. The spacer of claim 37 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.

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

40. An implantable spacer for placement between adjacent spinous processes, the implantable spacer comprising:

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

a first arm and a second arm, each of the first and second arms having rigid extensions that are spaced apart to receive a spinous process;

an actuator configured to move along the passageway to deploy the arms from an undeployed configuration in which the rigid extensions are substantially parallel to the longitudinal axis of the body and the extensions extend away from the body to a deployed configuration in which the rigid extensions extend alongside the spinous processes; and

a retainer rotatable relative to the body and the actuator such that rotation of the retainer causes translation of the actuator along the passageway to move the arms from the undeployed configuration to the deployed configuration.