Multi-level interspinous implants and methods of use

• US 8,372,117 B2
• Filed: 06/05/2009
• Issued: 02/12/2013
• Est. Priority Date: 06/05/2009
• Status: Expired due to Fees

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Phan, Christopher U., Schummers, David M.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): Carter, Tara
• Application Number:
  US12/479,072
• Publication Number:
  US 20100312277A1
• Time in Patent Office: 1,348 Days
• Field of Search: 606246-279
• US Class Current: 606/248
• 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 17/7068 Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor

Abstract

Multi-level interspinous implants and methods of using the implants with the implants generally include a first member for placement in a first interspinous space and a second member for placement in a second interspinous space. An elongated connector extends from one of the members and is sized to fit in a slot in the other member. Each of the first and second members may include a distal wing, a body, and a proximal wing. The members may also be positioned in a closed orientation for insertion into the patient and a deployed orientation with the distal and proximal wings extending outward along lateral sides of respective spinous processes. The connector may extend outward from the proximal wing of one of the members and away from the other member when that member is in the closed orientation. The connector may be rotated and inserted into the slot where it is secured when that member from which is extends is moved to the deployed orientation.

Claims

1. A multi-level interspinous implant comprising:

first and second members that each include a body positioned between a distal wing and a proximal wing, the bodies each including a superior side and an inferior side, the distal and proximal wings of the first member being connected together by a first extension that extends through the first member body and the wings of the second member being connected together by a second extension that extends through the second member body, the members being individually rotatable from a closed orientation with the distal wing aligned with the body and a deployed orientation with both the distal and proximal wings extending outward beyond the superior side of the body to maintain a lateral position of the members, the proximal wing of the first member defines an axis, the proximal wing of the second member is disposed along the axis;

a connector with an elongated length and first and second ends, the first end connected to the proximal wing of the first member and the second end positioned away from the proximal wing of the first member, the proximal wing of the first member is configured to rotate along the axis towards the proximal wing of the second member such that the connector engages the proximal wing of the second member in substantially perpendicular alignment;

a slot that extends into the proximal wing of the second member and includes a width configured to receive the connector, the slot positioned in a posterior side and at least one of the superior and inferior sides of the proximal wing of the second member when the second member is in the deployed orientation, such that the second end of the connector is configured to be adjustable between being disposed within the proximal wing of the second member and extending past an inferior side of the proximal wing of the second member allowing for proper adjustment of the first and second members;

the connector extending outward in a posterior direction from the proximal wing of the first member and away from the second member when the first member is in the closed orientation, and positioned in the slot when the first member is in the deployed orientation;

wherein the proximal wing of the first member includes a first cavity on a first side sized to receive the first end of the connector and a second cavity on a second side that is in communication with the first cavity.

2. The implant of claim 1, wherein a trailing end of the distal wing and the body of the first member each include an elongated shape with a major axis and a minor axis, the major axes being parallel when the first member is in the closed orientation and are nonparallel when the first member is in the deployed orientation.

3. The implant of claim 1, wherein the distal wings and the bodies of the first and second members are substantially identical.

4. The implant of claim 1, wherein the first body includes a first aperture through which the first extension extends and the second body includes a second aperture through which the second extension extends, the apertures being sized for the extensions to rotate in the bodies when the members move from the closed orientation to the deployed orientation without rotating the bodies.

5. The implant of claim 1, wherein the connector extends outward from an inferior side of the first member when the first member is in the deployed orientation.

6. The implant of claim 1, wherein the distal wings of the members extend outward beyond the superior sides of the bodies when the members are in the closed orientations.

12. A method of treating a spinal disorder of a patient using the device of claim 1 comprising:

unilaterally inserting the first member while in a closed orientation into the patient and positioning the first distal wing on a first lateral side of a first interspinous space, positioning the first body in the first interspinous space, and positioning the first proximal body on a second lateral side of the first interspinous space, each of the first distal wing, first body, and first proximal body being connected together and aligned along a first longitudinal axis;

unilaterally inserting the second member while in a closed orientation into the patient and positioning the second distal wing on the first lateral side of a second interspinous space, positioning the second body in a second interspinous space, and positioning the second proximal body on a second lateral side of the second interspinous space, each of the second distal wing, second body, and second proximal body being connected together and aligned along a second longitudinal axis;

positioning the elongated connector that extends outward from the first proximal body away from the second member;

moving the second member from the closed orientation to a deployed orientation by rotating the second distal wing and the second proximal wing relative to the second body and positioning sections of the second distal wing and the second proximal wing along opposing sides of the second spinous process;

moving the first member from the closed orientation to the deployed orientation by rotating the first distal wing and the first proximal wing relative to the first body and positioning sections of the first distal wing and the first proximal wing along opposing sides of a first spinous process; and

rotating the connector towards the second member and inserting the connector into the slot formed in superior and posterior sides of the second proximal wing and connecting the first member and the second member.

13. The method of claim 12, further comprising positioning a superior surface of the second body outward farther in a superior direction than the second distal wing when the second member is in the closed orientation.

14. The method of claim 12, wherein positioning the connector outward from the first proximal body away from the second member includes positioning the connector in a posterior direction when the first member is in the closed orientation.

15. The method of claim 12, wherein the connector is connected to the first proximal wing moving the first member from the closed orientation to the deployed orientation and inserting the connector into the slot occur simultaneously.

16. The method of claim 12, further comprising positioning the superior side of the second proximal wing away from the first member when the second member is in the closed orientation.

17. The method of claim 12, further comprising attaching a set screw to the second proximal wing and securing the connector in the slot.

18. The method of claim 12, further comprising pivotally moving the connector about a rounded head positioned in the first proximal wing prior to inserting the connector into the slot in the second proximal member.

19. The method of claim 12, wherein positioning the first body in the first interspinous space includes positioning the first body in a L4/L5 interspinous space and positioning the second body in the second interspinous space includes positioning the first body in a L5/S1 interspinous space.

7. A multi-level interspinous implant comprising:

a superior member with a first body positioned between a first distal wing and a first proximal wing, the first body including a superior side to contact against an inferior side of a first spinous process and an inferior side to contact against a superior side of a second spinous process, the proximal wing of the superior member defines an axis, the first distal and proximal wings being connected together by an extension that extends through the first body and are movable from a closed orientation and a deployed orientation with the first distal wing extending above the superior side of the first body in the deployed orientation, the first proximal wing also extending outward beyond the superior side of the body in the deployed orientation;

an elongated connector having a first end and a second end that extends outward from an inferior side of the first proximal wing;

an inferior member with a second body positioned between a second distal wing and a second proximal wing, the proximal wing of the inferior member being disposed along the axis, the second body including a superior side to contact against an inferior side of the second first spinous process and an inferior side to contact against a superior side of a second spinous process, the second distal and proximal wings being connected together by an extension that extends through the second body and are movable from a closed orientation and a deployed orientation with the second distal wing extending above the superior side of the second body in the deployed orientation, the second proximal wing also extending outward beyond the superior side of the second body in the deployed orientation, the second proximal wing including a slot that extends into posterior and superior sides, the slot including a width to receive the connector;

the first proximal wing being movable from the closed orientation with the connector extending outward in a posterior direction to the open position with the connector positioned in the slot of the second proximal wing and positioned to extend along a lateral side of the second spinous process, the proximal wing of the superior member is configured to rotate along the axis towards the proximal wing of the inferior member such that the elongated connector engages the slot of the proximal wing of the inferior member in substantially perpendicular alignment, such that the second end of the connector is adjustable between being disposed within the proximal wing of the second member and extending past an inferior side of the proximal wing of the second member allowing for proper adjustment of the first and second members;

wherein the first proximal wing includes a first cavity sized to receive the connector, and a second cavity that is in communication with the first cavity.

8. The implant of claim 7, wherein the connector includes a round head at a first end positioned in the first cavity in the first proximal wing, the round head and the first cavity sized for the connector to be pivotally connected to the first proximal wing.

9. The implant of claim 8, wherein the further comprising a second cavity extends into the first proximal wing from a different direction than the first cavity the second cavity and the cavity being in communication in the first proximal wing.

10. The implant of claim 7, wherein the extension of the first proximal wing extends through the first body along a line that is offset from a longitudinal axis of the first body.

11. The implant of claim 7, wherein the first distal wing and the first body each include an elongated shape with a major axis and a minor axis, the major axes being parallel when the superior member is in the closed orientation and are non-parallel when the superior member is in the deployed orientation.