Systems and methods for in situ assembly of an interspinous process distraction implant

• US 8,641,762 B2
• Filed: 01/09/2012
• Issued: 02/04/2014
• Est. Priority Date: 10/24/2006
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Mitchell, Steven T., Winslow, Charles J., Yerby, Scott A.
• Primary Examiner(s): Hoffman, Mary
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US13/346,332
• Publication Number:
  US 20120109205A1
• Time in Patent Office: 757 Days
• Field of Search: 606246-249, 606/86.A, 606/90, 606/99, 606/105, 623 1711- 1716
• US Class Current: 623/17.11
• 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
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter

Abstract

An implant system for implantation between adjacent spinous processes for the relief of pain associated with the spine. The implant has a series of spacers which may be inserted over a shaft located between adjacent spinous processes thus allowing the implant to be assembled in situ. The spacers may rotate on the shaft relative to the wings. To minimize trauma to the patient, each spacer has a tapered tissue expander to distract the opening between the spinous processes during assembly. The shaft is connected to a wing, and a second wing or deployable wing may be inserted over the shaft and locked into place.

Claims

1. An implant to be assembled in situ for maintaining a space between adjacent spinous processes, the implant comprising:

a first wing attached to a shaft;

a first spacer which can slide onto the shaft after the shaft has been positioned between adjacent spinous processes wherein the first spacer comprises a first tissue expander which can distract the adjacent spinous processes when the first spacer is slid onto the shaft;

a second wing; and

a fastening device which engages the shaft and the second wing to secure the second wing to the shaft, the fastening device includes a locking ring and one or more flexible fingers configured to engage a locking groove disposed on the shaft.

2. The implant of claim 1 further comprising a second spacer which can slide over the first spacer after the first spacer has been positioned between adjacent spinous processes wherein the second spacer comprises a second tissue expander which can distract the adjacent spinous processes when the second spacer is slid over the first spacer.

3. The implant of claim 2 further comprising a third spacer which can slide over the second spacer after the second spacer has been positioned between adjacent spinous processes and wherein the third spacer comprises a third tissue expander which can distract the adjacent spinous processes when the third spacer is slid over the second spacer.

4. The implant of claim 3 further comprising a fourth spacer which can slide over the third spacer after the third spacer has been positioned between adjacent spinous processes and wherein the second spacer comprises a second tissue expander which can distract the adjacent spinous processes when the fourth spacer is slid over the third spacer.

5. The implant of claim 4 further comprising a fifth spacer which can slide over the fourth spacer after the fourth spacer has been positioned between adjacent spinous processes and wherein the fifth spacer comprises a fifth tissue expander which can distract the adjacent spinous processes when the fifth spacer is slid over the fourth spacer.

6. The implant of claim 1 wherein the first wing comprises a depression which can receive the first tissue expander after the first tissue expander has passed between the adjacent spinous processes to reduce subsequent contact between the adjacent spinous processes and the first tissue expander.

7. The implant of claim 1 wherein the shaft has a central longitudinal axis and maximum shaft diameter perpendicular to the longitudinal axis and wherein one of the first wing and the second wing has a maximum wing diameter perpendicular to the longitudinal axis of the shaft which, in a first configuration, is less than or approximately equal to the maximum shaft diameter, and which, in a second configuration, is greater than the maximum shaft diameter.

8. A method for in situ assembly of an implant for maintaining a space between adjacent spinous processes for a therapeutic purpose, wherein the implant comprises a shaft, a first wing, a second wing and at least one spacer and wherein the method comprises:

A) positioning the shaft between adjacent spinous processes;

B) distracting the adjacent spinous processes by positioning a first spacer over the shaft while the shaft is positioned between adjacent spinous processes;

C) fastening with a fastening adevice the second wing onto the shaft after the first spacer has been positioned over the shaft and while the shaft and first spacer are positioned between adjacent spinous processes thereby retaining the first spacer over the shaft and between the spinous processes, wherein the fastening device includes a locking ring and one or more flexible fingers configured to engage a locking groove disposed on the shaft.

9. The method of claim 8 wherein step B) comprises further distracting the adjacent spinous processes by positioning a second spacer over the first spacer while the first spacer is positioned between adjacent spinous processes.

10. The method of claim 9 wherein step B) comprises further distracting the adjacent spinous processes by positioning a third spacer over the first spacer while the second spacer is positioned between adjacent spinous processes.

11. The method of claim 10 wherein step B) comprises further distracting the adjacent spinous processes by positioning a fourth spacer over the third spacer while the third spacer is positioned between adjacent spinous processes.

12. The method of claim 11 wherein step B) comprises further distracting the adjacent spinous processes by positioning a fifth spacer over the fourth spacer while the fourth spacer is positioned between adjacent spinous processes.

13. The method of claim 8 wherein step B) comprises:

B) distracting the adjacent spinous processes by positioning a first spacer over the shaft while the shaft is positioned between adjacent spinous processes;

B1) incrementally distracting the adjacent spinous processes by sequentially inserting additional spacers over the shaft and all previously inserted spacers.

14. The method of claim 13 wherein step B) comprises:

B) distracting the adjacent spinous processes by positioning a first spacer over the shaft while the shaft is positioned between adjacent spinous processes;

B1) incrementally distracting the adjacent spinous processes by sequentially inserting additional spacers over the shaft and all previously inserted spacers;

B2) evaluating the space between the adjacent spinous processes after inserting each additional spacer.

15. The method of claim 8 wherein step B) comprises:

B) distracting the adjacent spinous processes by positioning a first spacer over the shaft while the shaft is positioned between adjacent spinous processes;

B1) evaluating the space between the adjacent spinous processes;

B2) incrementally distracting the adjacent spinous processes by inserting an additional spacer over the shaft and all previously inserted spacers; and

wherein steps B1 and B2 are repeated until the space between the adjacent spinous processes is determined to be adequate for the therapeutic purpose.

16. The method of claim 8 wherein the shaft has a central longitudinal axis and maximum shaft diameter perpendicular to the longitudinal axis and wherein the first wing has a maximum wing diameter perpendicular to the longitudinal axis of the shaft which, in a first configuration, is less than or approximately equal to the maximum shaft diameter, and which, in a second configuration, is greater than the maximum shaft diameter, wherein step A comprises:

A1) pushing the first wing in the first configuration between adjacent spinous processes until the first wing is distal to the adjacent spinous processes;

A2) causing the wing to transition from the first configuration to the second configuration; and

A3) positioning the shaft between adjacent spinous processes.

17. An implant to be assembled in situ for maintaining a space between adjacent spinous processes, the implant comprising:

a shaft insertable laterally between the spinous processes along an axis of the shaft;

a first wing attached to the shaft, the first wing extending from the shaft so as to inhibit movement of the shaft from the between the spinous processes;

a first spacer having an opening, the opening slidable onto and over the shaft after the shaft has been positioned between the adjacent spinous processes, the first spacer having a first tissue expander extending from a spacer body, the tissue expander tapering axially so as to distract the adjacent spinous processes when the first spacer is slid onto the shaft, the spacer body configured to maintain distraction of the adjacent spinous processes;

a second, third, fourth and fifth spacer configured for incremental distraction of the adjacent spinous processes by sequentially inserting the first, second, third, fourth and fifth spacers over the shaft and all previously inserted spacers;

a second wing securable to the shaft so as to restrain the spacer between the wings while the wings inhibit movement of the shaft from between the spinous processes. the wings inhibit movement of the shaft from between the spinous processes.