Interspinous spacer

• US 9,861,398 B2
• Filed: 08/25/2015
• Issued: 01/09/2018
• 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:
  US14/835,195
• Publication Number:
  US 20160045232A1
• Time in Patent Office: 868 Days
• 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. A method for treating a subject, comprising:

splitting the subject'"'"'s supraspinous ligament to create an opening;

moving a cannula through the opening located generally along the subject'"'"'s midline;

delivering an interspinous implant device through the cannula and to an interspinous space along the subject'"'"'s spine;

rotating a first rotating member of the interspinous implant device to move a first superior extension of the first rotating member along a first side of a superior spinous process and to move a first inferior extension of the first rotating member along a first side of an inferior spinous process;

rotating a second rotating member of the interspinous implant device to move a second superior extension of the second rotating member along a second side of the superior spinous process and to move a second inferior extension of the second rotating member along a second side of the inferior spinous process; and

removing the cannula from the subject while the superior spinous process is positioned directly between the first and second superior extensions and the inferior spinous process is positioned directly between the first and second inferior extensions.

2. The method of claim 1, further comprising:

concurrently rotating the first and second rotating members by using the delivering instrument connected to the interspinous implant device and extending through the cannula;

separating the delivery instrument from the interspinous implant device; and

removing the delivery instrument from the cannula.

3. The method of claim 1, wherein delivering the interspinous implant device through the cannula includes moving the interspinous implant device along the passageway of the cannula while longitudinal axes of the first and second rotating members are aligned with the passageway.

4. The method of claim 1, wherein rotating the first and second rotating members includes:

rotating the first and second superior extensions together in a superior direction relative to the subject'"'"'s spine so as to position the superior spinous process directly between the first and second superior extensions; and

rotating the first and second inferior extensions together in an inferior direction relative to the subject'"'"'s spine so as to position the inferior spinous process directly between the first and second inferior extensions.

5. The method of claim 1, further comprising rotating the first and second rotating members about a common rotational axis.

6. The method of claim 1, wherein rotating the first and second rotating members includes rotating each of the first and second rotating members relative to a main body of the interspinous spacer about 90 degrees.

7. The method of claim 1, wherein rotating the first rotating member includes rotating the first rotating member relative to a main body of the interspinous spacer less than about 90 degrees.

8. The method of claim 1, wherein rotating the first rotating member includes rotating the first rotating member relative to a main body of the interspinous spacer more than about 90 degrees.

9. A method for treating a subject, comprising:

moving a cannula through an opening located generally along the subject'"'"'s midline;

delivering an interspinous implant device through the cannula and to an interspinous space along the subject'"'"'s spine;

rotating a first rotating member of the interspinous implant device to move a first superior extension of the first rotating member along a first side of a superior spinous process and to move a first inferior extension of the first rotating member along a first side of an inferior spinous process;

rotating a second rotating member of the interspinous implant device to move a second superior extension of the second rotating member along a second side of the superior spinous process and to move a second inferior extension of the second rotating member along a second side of the inferior spinous process; and

removing the cannula from the subject while the superior spinous process is positioned directly between the first and second superior extensions and the inferior spinous process is positioned directly between the first and second inferior extensions,

wherein the method further comprises;

moving an end of the cannula through a supraspinous ligament of the subject;

advancing the interspinous implant device along a passageway of the cannula while longitudinal axes of the first and second rotating members extend in a direction substantially parallel to a longitudinal axis of the passageway; and

after delivering the interspinous implant device through the cannula, driving an actuator of the interspinous implant device using a delivery instrument connected to the interspinous implant device to cause rotation of the first and second rotating members.

10. A method for treating a subject, comprising:

positioning a cannula through the subject'"'"'s supraspinous ligament;

delivering an interspinous spacer through the cannula and to an interspinous space in the subject; and

rotating a wing assembly of the interspinous spacer relative to a body of the interspinous spacer while the body is located at the interspinous space such that

first and second superior extensions of the wing assembly move superiorly relative to the subject'"'"'s spine to position the subject'"'"'s superior spinous process between the first and second superior extensions, and

first and second inferior extensions of the wing assembly move inferiorly relative to the subject'"'"'s spine to position the subject'"'"'s inferior spinous process between the first and second inferior extensions.

11. The method of claim 10, further comprising rotating first and second elongate members of the wing assembly together about an axis of rotation extending through the body of the interspinous spacer positioned between the first and second elongate members to move the wing assembly from a delivery configuration for delivery into the interspinous space to a deployed configuration for spacing apart the superior and inferior spinous processes.

12. The method of claim 10, further comprising:

advancing the interspinous spacer along a passageway of the cannula while the first and second superior extensions and the first and second inferior extensions extend in a direction substantially parallel to a longitudinal axis of the passageway; and

after delivering the interspinous spacer through the cannula, operating a delivery instrument extending through the cannula and connected to the interspinous spacer to drive an actuator of the interspinous spacer which causes rotation of the wing assembly.

13. The method of claim 10, further comprising:

mechanically driving an actuator of the interspinous spacer using a delivery instrument to gradually rotate the wing assembly; and

separating the delivery instrument from the interspinous spacer which is positioned at the interspinous space.

14. The method of claim 10, wherein the first superior extension and the first inferior extension are part of a first rotatable member, wherein the second superior extension and the second inferior extension are part of a second rotatable member, and the method further includes:

pivoting the first and second rotatable members relative to the body about a common axis of rotation that is generally perpendicular a sagittal plane of the interspinous spacer to rotate the wing assembly.

15. The method of claim 14, wherein most of the body is positioned directly between the first and second rotatable members while the interspinous spacer is delivered through the cannula.

16. The method of claim 14, wherein the first and second rotatable members are substantially parallel to one another while the interspinous spacer is delivered through the cannula.

17. A minimally-invasive percutaneous method for treating a subject, comprising:

moving an interspinous spacer in a delivery configuration along an anterior-to-posterior delivery path and to an interspinous space, wherein the interspinous spacer includes—

a body with an actuator,

a first elongate member, and

a second elongate member, wherein the first and second elongate members are pivotally coupled to and aligned with the body when the interspinous spacer is in the delivery configuration; and

driving the actuator using a delivery instrument releasably connected to the interspinous spacer to pivot the first and second elongate members relative to the body so as to move the interspinous spacer to a deployed configuration such that a superior spinous process is located directly between the first and second elongate members and an inferior spinous process is located directly between the first and second elongate members,

wherein the method further comprises

moving an end of the cannula through a supraspinous ligament of the subject; and

moving the interspinous spacer along a passageway of the cannula while longitudinal axes of the first and second elongate members extend in a direction substantially parallel to a path of travel of the interspinous spacer along the passageway.

18. The method of claim 17, wherein the entire interspinous spacer is capable of being located inferior relative to the superior spinous process and superior relative to the inferior spinous process when the body of the interspinous spacer, in the delivery configuration, is positioned at the interspinous space.

19. The method of claim 17, further comprising distracting the superior and inferior spinous processes by moving the interspinous spacer to the deployed configuration.

20. The method of claim 17, further comprising moving the interspinous spacer in the delivery configuration through the cannula while the cannula is positioned through the supraspinous ligament.

21. The method of claim 17, further comprising moving at least a portion of the interspinous spacer out of the cannula before pivoting the first and second elongate members relative to the body.

22. A minimally-invasive percutaneous method for treating a subject, comprising:

moving an interspinous spacer in a delivery configuration along an anterior-to-posterior delivery path and to an interspinous space, wherein the interspinous spacer includes—

a body with an actuator,

a first elongate member, and

a second elongate member, wherein the first and second elongate members are pivotally coupled to and aligned with the body when the interspinous spacer is in the delivery configuration; and

driving the actuator using a delivery instrument releasably connected to the interspinous spacer to pivot the first and second elongate members relative to the body so as to move the interspinous spacer to a deployed configuration such that a superior spinous process is located directly between the first and second elongate members and an inferior spinous process is located directly between the first and second elongate members

wherein the method further comprises operating the delivery instrument to rotate the first and second elongate members together about a common axis of rotation that extends substantially perpendicular to a sagittal plane of the interspinous spacer.