INTERSPINOUS SPACER

• US 20150164560A1
• Filed: 09/16/2014
• Published: 06/18/2015
• 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, Kim, Daniel H., Tebbe, Shawn
• Granted Patent: US 9,532,812 B2
• Time in Patent Office: Days
• 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 17/7076 for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation

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 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 receiving portion configured for seating a spinous process of a scoliotic spine or a spine with misaligned spinous processes. Each arm has a proximal caming surface and is capable of rotation with respect to the body. An actuator assembly is disposed inside the longitudinal 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 superior and inferior arms of the spacer. Variations adapted for scoliotic curves are provided.

Claims

1-22. -22. (canceled)

23. An implant for placement between a superior spinous process and an inferior spinous process of a curved spine, the implant comprising:

a body;

a superior arm having superior elongate members spaced apart to receive the superior spinous process therebetween, wherein the superior arm is rotatable relative to the body about a first superior axis to move the superior elongate members in a superior direction such that the superior elongate members move along opposite sides of the superior spinous process while the body is located at an interspinous space between the superior and inferior spinous processes; and

an inferior arm having inferior elongate members spaced apart to receive the inferior spinous process therebetween, wherein the inferior arm is rotatable relative to the body about a first inferior axis to move the inferior elongate members in an inferior direction such that the inferior elongate members move along opposite sides of the inferior spinous process while the body is located at the interspinous space;

wherein the superior arm and/or the inferior arm has an unlocked state for rotating relative to the body in a lateral direction relative to the body to accommodate curvature of the spine and a locked state for preventing rotation relative to the body such that the superior and inferior arms hold the superior and inferior spinous process, respectively, of the curved spine.

24. The implant of claim 23, wherein the body defines a sagittal plane and a transverse plane, wherein the superior and inferior elongate members are positioned on opposite sides of and parallel to the transverse plane when the superior and inferior arms are in undeployed positions, and wherein the first inferior axis and the first superior axis are generally perpendicular to the sagittal plane.

25. The implant of claim 24, wherein the superior arm and/or the inferior arm in the unlocked state is rotatable relative to the body about a second axis that is substantially parallel to the transverse plane and extends in a direction substantially parallel to the sagittal plane.

26. The implant of claim 23, wherein the superior arm and/or the inferior arm has a drive tool engagement feature configured to engage a drive tool adapted to change the superior and/or inferior arm from the unlocked state to the locked state.

27. The implant of claim 23, wherein the superior elongate members and/or the inferior elongate members are generally parallel to a longitudinal axis of the body when the superior and inferior arms are in an undeployed position, and wherein the superior elongate members and/or the inferior elongate members extend away from the longitudinal axis of the body when the superior and inferior arms are in a deployed position.

28. The implant of claim 23, wherein the body defines a sagittal plane that is generally perpendicular to the first superior axis and/or the first inferior axis, wherein the superior arm is rotatable relative to the body about a second superior axis that is substantially parallel to the sagittal plane, and wherein the inferior arm is rotatable relative to the body about a second inferior axis that is substantially parallel to the sagittal plane.

29. The implant of claim 23, wherein the body defines a sagittal plane that is generally perpendicular to the first superior axis and/or the first inferior axis, and wherein the superior arm and/or the inferior arm in the unlocked state is movable in the lateral direction to adjust an angular position of the superior and/or inferior elongate members relative to the sagittal plane.

30. The implant of claim 23, wherein the superior arm has a superior bridge extending between the superior elongate members, wherein the inferior arm has an inferior bridge extending between the inferior elongate members, and wherein the superior and inferior bridges are configured to contact the superior and inferior spinous processes, respectfully, when the superior and inferior arms are in a deployed configuration.

31. The implant of claim 23, further comprising an actuator connectable to a delivery instrument configured to be operated by a user, and wherein the actuator is configured to drive the superior and inferior arms about the first superior axis and the first inferior axis, respectively, by operation of the delivery instrument.

32. An implant for placement between a first spinous process and a second spinous process of a curved spine, the implant comprising:

a main body defining a plane;

a first arm and a second arm, wherein the first arm is rotatable relative to the main body about a first axis that is substantially perpendicular to the plane, wherein the second arm is rotatable relative to the main body about a second axis substantially perpendicular to the plane, wherein the first arm is rotatable relative to the main body to move away from the plane to adjust a relative position of the first arm to accommodate curvature of the curved spine; and

an actuator configured to be driven by an instrument removably coupled to the implant, wherein the actuator is coupled to the main body and configured to rotate the first and second arms about the respective first and second axes from an undeployed configuration for delivery into an interspinous space between the first and second axes to a deployed configuration for holding the superior and inferior spinous processes.

33. The implant of claim 32, wherein the first am includes first elongate members, wherein the second arm includes second elongate members, wherein the first and second elongate members are generally parallel to and positioned on opposite sides of a transverse plane of the main body when the first and second arms are in the undeployed configuration, and wherein the first elongate members and the second elongate members are generally perpendicular to the transverse plane when the first and second arms are in the deployed configuration.

34. The implant of claim 32, wherein the plane is a sagittal plane, and wherein the first arm in an unlocked state is rotatable about a lateral adjustment axis that extends in a direction that is substantially parallel to the sagittal plane.

35. The implant of claim 32, wherein the first arm has a drive tool engagement feature configured to receive a drive tool configured to change the first arm from an unlocked state for adjusting an angular position of the first arm relative to the plane to a locked state for preventing adjustment of the angular position of the first arm relative to the plane.

36. The implant of claim 32, wherein the first am includes first elongate members, wherein the second arm includes second elongate members, wherein the first elongate members and/or the second elongate members are generally parallel to a longitudinal axis of the main body when the first and second arms are in an undeployed position, and wherein the first elongate members and the second elongate members extend in a direction generally orthogonal to a transverse plane of the main body when the first and second arms are in a deployed position.

37. The implant of claim 32, wherein the plane is a sagittal plane that is substantially perpendicular to the first axis and/or the second axis, and wherein the first arm is rotatable about a third axis that is substantially parallel to the sagittal plane, and wherein the second arm is rotatable about fourth axis that is substantially parallel to the sagittal plane.

38. An implant for placement between a first spinous process and a second spinous process of a curved spine, the implant comprising:

a main body defining a sagittal plane;

a first arm rotatable relative to the main body about a first axis that is substantially perpendicular to the sagittal plane, wherein the first arm has an unlocked state for moving laterally relative to the main body to angle the first arm relative to the sagittal plane to accommodate curvature of the curved spine and a locked state for preventing movement of the first arm laterally relative to the main body;

a second arm rotatable relative to the main body about a second axis that is substantially perpendicular to the sagittal plane and spaced apart from the first axis,

wherein the implant is configured to be connected to an instrument operated by a user such that the instrument causes the first and second arms to rotate about the first and second axes, respectively, to position the first spinous process in the first arm and the second spinous process in the second arm when the main body is positioned at the interspinous space.

39. The implant of claim 38, wherein the main body defines a transverse plane, and wherein first elongate members of the first arm are movable along opposite sides of the first spinous process and the second elongate members of the second arm are movable along on opposite sides of the second spinous process when the implant moves from an undeployed configuration toward a deployed configuration.

40. The implant of claim 38, wherein the first arm is rotatable about the first axis independently of an angular position of the first arm relative to the sagittal plane.