Interspinous spacer

• US 9,119,680 B2
• Filed: 02/27/2012
• Issued: 09/01/2015
• 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
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US13/406,442
• Publication Number:
  US 20120158063A1
• Time in Patent Office: 1,282 Days
• Field of Search: 623/17.11, 606246-249, 606/279, 606/277, 606/276
• US Class Current: 1/1
• 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 2017/564 Methods for bone or joint treatment

Abstract

An implantable spacer for placement between adjacent spinous processes is provided. The spacer includes a body and a wing rotatably connected to the body. The wing includes two U-shaped configurations that together define a substantially H-shaped configuration for retaining the spacer between adjacent spinous processes. An actuator assembly is connected to the body and to the wing with the proximal end of the spacer being connectable to a removable driver that is configured to engage the actuator assembly. While connected to the spacer, the driver is rotatable in one direction to deploy the wing from an undeployed to a deployed configuration and in an opposite direction to undeploy the wing. In the deployed configuration, the spacer acts as a space holder opening up the area of the spinal canal, maintaining foraminal height, reducing stress on the facet joints and relieving pain for the patient.

Claims

1. An interspinous spacer comprising:

a body configured to be positioned between a superior spinous process and an inferior spinous process;

a wing assembly coupled to the body, the wing assembly comprising—

a first rotating member having a first inferior extension and a first superior extension; and

a second rotating member having a second inferior extension and a second superior extension, wherein the first and second rotating members rotate about a common rotational axis; and

an actuator coupled to the body and configured to rotate the wing assembly relative to the body such that—

the first and second inferior extensions rotate together in a posterior or anterior direction such that the inferior spinous process is positioned between the first and second inferior extensions; and

the first and second superior extensions rotate together in a corresponding anterior or posterior direction opposite the first and second inferior extensions such that the superior spinous process is positioned between the first and second superior extensions.

2. The interspinous spacer of claim 1 wherein:

the first and second inferior extensions rotate together in the posterior direction; and

the first and second superior extensions rotate together in the anterior direction opposite the first and second inferior extensions.

3. The interspinous spacer of claim 1 wherein the body has a first lateral portion and a second lateral portion, and wherein the first rotating member is at the first lateral portion and the second rotating member is at the second lateral portion.

4. The interspinous spacer of claim 1 wherein the body, wing assembly and actuator are configured to be passed through a cannula in an undeployed state.

5. The interspinous spacer of claim 1 wherein the body has a longitudinal axis, and the actuator is configured to be rotatably driven by a driver removably coupled to the actuator such that the wing assembly rotates relative to the body when the longitudinal axis of the body extends in a substantial anterior to posterior direction.

13. The spacer of claim 3 wherein the body, wing assembly and actuator are configured to pass through a cannula in the undeployed configuration.

6. An implantable spacer for placement between a superior spinous process and an inferior spinous process, each of the superior and inferior spinous processes having a first lateral surface opposite a second lateral surface, the spacer comprising:

a body configured to be positioned between the superior and inferior spinous processes, the body having a first lateral side and a second lateral side;

a wing assembly coupled to the body, the wing assembly comprising—

a first arm at the first lateral side of the body; and

a second arm at the second lateral side of the body, wherein the first and second arms are rotatable about a common axis; and

an actuator coupled to the body and configured to rotate the first and second arms in a common rotational direction from an undeployed configuration to a deployed configuration, wherein in the deployed configuration the first arm is adjacent to the first lateral surface of the superior and inferior spinous processes and the second arm is adjacent to the second lateral surface of the superior and inferior processes.

12. The spacer of claim 6 wherein the actuator is configured to rotate the first and second arms in the common rotational direction relative to the body when the body is positioned between the superior and inferior spinous processes.

14. The spacer of claim 6 wherein the body has a longitudinal axis, and the actuator is configured to be rotatably driven by a driver removably coupled to the actuator such that the wing assembly rotates relative to the body when the longitudinal axis of the body extends in a substantial anterior to posterior direction.

7. A interspinous spacer comprising:

a body configured to be positioned between a superior spinous process and an inferior spinous process;

a wing assembly coupled to the body, the wing assembly comprising—

a first rotating member having a first inferior extension and a first superior extension; and

a second rotating member having a second inferior extension and a second superior extension;

an actuator coupled to the body and configured to rotate the wing assembly relative to the body such that—

the first and second inferior extensions rotate together in a posterior or anterior direction such that the inferior spinous process is positioned between the first and second inferior extensions; and

the first and second superior extensions rotate together in a corresponding anterior or posterior direction opposite the first and second inferior extensions such that the superior spinous process is positioned between the first and second superior extensions;

wherein the first inferior extension and the first superior extension extend coincidentally along a common axis in an undeployed state; and

wherein the second inferior extension and the second superior extension extend coincidentally along a common axis in an undeployed state.

8. The interspinous spacer of claim 7 wherein:

the first inferior extension and the first superior extension extend coincidentally along a common axis in a deployed state; and

the second inferior extension and the second superior extension extend coincidentally along a common axis in a deployed state.

9. An interspinous spacer comprising:

a body configured to be positioned between a superior spinous process and an inferior spinous process;

a wing assembly coupled to the body, the wing assembly comprising—

a first rotating member having a first inferior extension and a first superior extension; and

a second rotating member having a second inferior extension and a second superior extension; and

an actuator coupled to the body and configured to rotate the wing assembly relative to the body such that—

the first and second inferior extensions rotate together in a posterior or anterior direction such that the inferior spinous process is positioned between the first and second inferior extensions; and

the first and second superior extensions rotate together in a corresponding anterior or posterior direction opposite the first and second inferior extensions such that the superior spinous process is positioned between the first and second superior extensions;

wherein the first inferior extension and the first superior extension are integral with each other; and

wherein the second inferior extension and the second superior extension are integral with each other.

10. An interspinous spacer comprising:

a body configured to be positioned between a superior spinous process and an inferior spinous process;

a wing assembly coupled to the body, the wing assembly comprising—

a first rotating member having a first inferior extension and a first superior extension,

a second rotating member having a second inferior extension and a second superior extension, and

a cross member extending between the first and second rotating members, wherein the cross member includes a caming feature; and

an actuator coupled to the body and configured to rotate the wing assembly relative to the body such that—

the first and second inferior extensions rotate together in a posterior or anterior direction such that the inferior spinous process is positioned between the first and second inferior extensions, and

the first and second superior extensions rotate together in a corresponding anterior or posterior direction opposite the first and second inferior extensions such that the superior spinous process is positioned between the first and second superior extensions, and

wherein the actuator includes a caming surface configured to contact the caming feature of the cross member surface to rotate the wing assembly.

11. The interspinous spacer of claim 10 wherein the caming surface includes a locking portion configured to at least partially retain the wing assembly in a deployed state.

15. An implantable spacer for placement between a superior spinous process and an inferior spinous process, each of the superior and inferior spinous processes having a first lateral surface opposite a second lateral surface, the spacer comprising:

a body configured to be positioned between the superior and inferior spinous processes, the body having a first lateral side and a second lateral side;

a wing assembly coupled to the body, the wing assembly comprising—

a first arm at the first lateral side of the body, the first arm includes a first superior extension and a first inferior extension; and

a second arm at the second lateral side of the body, the second arm includes a second superior extension and a second inferior extension; and

an actuator coupled to the body and configured to rotate the first and second arms in a common rotational direction from an undeployed configuration to a deployed configuration, wherein in the deployed configuration the first arm is adjacent to the first lateral surface of the superior and inferior spinous processes and the second arm is adjacent to the second lateral surface of the superior and inferior processes

wherein in the deployed configuration the first and second superior extensions are configured to be positioned adjacent to the superior spinous process, and the first and second inferior extensions are configured to be positioned adjacent to the inferior spinous process;

wherein the first superior extension and the first inferior extension extend coincidentally along a first common axis in the deployed and undeployed configurations; and

wherein the second superior extension and the second inferior extension extend coincidentally along a second common axis in the deployed and undeployed configurations.

16. The spacer of claim 15 wherein

the first and second inferior extensions rotate together in a posterior or anterior direction;

and

the first and second superior extensions rotate together in a corresponding anterior or posterior direction opposite the first and second inferior extensions.

17. An implantable spacer for placement between a superior spinous process and an inferior spinous process, each of the superior and inferior spinous processes having a first lateral surface opposite a second lateral surface, the spacer comprising:

a body configured to be positioned between the superior and inferior spinous processes, the body having a first lateral side and a second lateral side;

a wing assembly coupled to the body, the wing assembly comprising—

a first arm at the first lateral side of the body; and

a second arm at the second lateral side of the body; and

an actuator coupled to the body and configured to rotate the first and second arms in a common rotational direction from an undeployed configuration to a deployed configuration, wherein in the deployed configuration the first arm is adjacent to the first lateral surface of the superior and inferior spinous processes and the second arm is adjacent to the second lateral surface of the superior and inferior processes;

wherein the wing assembly further comprises a cross member extending between the first arm and the second arm, wherein the cross member has a caming feature that engages the actuator.

18. An implantable spacer for placement between a superior spinous process and an inferior spinous process of a subject, the spacer comprising:

a body configured to be positioned between the superior and inferior spinous processes and having a long axis;

a wing assembly rotatably coupled to the body, the wing assembly comprising—

a first arm positioned on a first side of the body, and

a second arm positioned on a second side of the body; and

an actuator configured to rotate the first and second arms from an undeployed configuration to a deployed configuration when the actuator is driven by a driver removably coupled to the actuator and the long axis of the body is at an anterior to posterior orientation, and wherein in the deployed configuration the first arm is adjacent to first lateral surfaces of the superior and inferior spinous processes and the second arm is adjacent to second lateral surfaces of the superior and inferior spinous processes.

19. The implantable spacer of claim 18 wherein the wing assembly is configured to engage the superior and inferior spinous processes to keep the long axis of the body in a substantially posterior to anterior direction relative to the subject'"'"'s spine.

20. The implantable spacer of claim 18 wherein the actuator is configured to rotate the first and second arms from a substantially posterior-anterior orientation to a substantially superior-inferior orientation while the body is positioned between the superior and inferior spinous processes.

21. The implantable spacer of claim 18 wherein the actuator is configured to rotate the first and second arms relative to the body such that the first and second arms move from the undeployed configuration to the deployed configuration when both the long axis of the body and a long axis of the driver are at the anterior to posterior orientation.

22. The implantable spacer of claim 18 wherein

the first arm has a first long axis and the second arm has a second long axis, wherein the long axis of the body, the first long axis, and the second long axis extend in the same general direction when the first and second arms are in the undeployed configuration, and

the actuator is connected to the body and positioned between the first and second arms such that, when the driver extends through a supraspinous ligament of the subject, the driver is capable of driving the actuator to cause rotation of the first and second arms toward the deployed configuration in which the first and second long axes are oriented in an inferior-to-superior orientation and extend along the superior and inferior spinous processes while the long axis of the body is at the anterior-to-posterior orientation and is positioned directly between the superior and inferior spinous processes.

23. An interspinous spacer comprising:

a body configured to be positioned between a superior spinous process and an inferior spinous process;

a wing assembly coupled to the body, the wing assembly comprising—

a first rotating member having a first inferior extension and a first superior extension, and

a second rotating member having a second inferior extension and a second superior extension, wherein the first and second rotating members rotate about a common rotational axis; and

an actuator coupled to the body and configured to rotate the wing assembly relative to the body such that—

the first and second inferior extensions rotate together in a posterior or anterior direction such that the inferior spinous process is positioned between the first and second inferior extensions, and

the first and second superior extensions rotate together in a corresponding anterior or posterior direction opposite the first and second inferior extensions such that the superior spinous process is positioned between the first and second superior extensions;

wherein the actuator is configured to rotate the first and second inferior extensions and the first and second superior extensions relative to the superior and inferior spinous processes while the body is positioned directly between the superior and inferior spinous processes and a long axis of the body extends in the anterior to posterior direction relative to the superior and inferior spinous processes.