SYSTEM AND METHOD FOR STRENGTHENING A SPINOUS PROCESS

• US 20080027435A1
• Filed: 04/19/2007
• Published: 01/31/2008
• Est. Priority Date: 06/22/2006
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: St. Francis Medical Technologies, Inc. (Medtronic Plc)
• Inventors: Hsu, Ken, Yerby, Scott, Mitchell, Steven, Zucherman, James
• Granted Patent: US 7,862,569 B2
• Time in Patent Office: Days
• US Class Current: 606/61
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/90 Guides therefor

Abstract

Systems, procedures and tools for repairing, or reinforcing the spinous process. The systems and procedures provide for injecting bone cement into and optionally around the spinous process. Additional reinforcing elements may be embedded in the bone cement inside or outside the spinous process. The procedures include positioning of the guide and reinforcing elements relative to a spinous process, preparation of the spinous process for injection and injection of bone cement into the spinous process. Tools are provided to facilitate the accurate injection of bone cement. The systems and procedures increase the strength of the spinous process and enhance the applicability and outcome of spinal interventions.

Claims

1. A guide for use in a procedure to introduce a surgical instrument having an insertion axis and a distal tip along a desired axis of a spinous process of a vertebra wherein the guide comprises:

a first arm comprising a first guide surface adapted to engage the spinous process;

a second arm comprising a second guide surface adapted to engage the spinous process;

a handle operatively coupled to the first arm and the second arm;

a guide bore adapted to allow passage of the surgical instrument; and

wherein the handle is operative to change a distance between the first guide surface and the second guide surface and the guide bore is adapted to control the insertion axis of the instrument such that engagement of the spinous process by the first guide surface and the second guide surface aligns the insertion axis of the instrument with the desired axis of the spinous process.

2. The guide of claim 1, wherein:

the handle comprises a first handle element connected to the first arm and a second handle element connected to the second arm;

and wherein the first arm is pivotally connected to the second arm such that the distance between the first guide surface and the second guide surface is increased when the distance between the first handle element and the second handle element is decreased.

3. The guide of claim 1, further comprising:

a spring element which biases the first side surface towards the second guide surface;

and wherein the handle is operative to increase the distance between the first guide surface and the second guide surface against the biasing of the spring element.

4. The guide of claim 1, wherein:

the handle is movably connected to the arms such that the distance between the first guide surface and the second guide surface is decreased when the handle is pushed towards the first arm and second arm.

5. The guide of claim 1, further comprising:

a lock element which maintains the distance between the first guide surface and the second guide surface.

6. The guide of claim 5, wherein the lock element includes a plurality of detent positions to selectively maintain the distance between the first guide surface and the second guide surface.

7. The guide of claim 5, further comprising:

a release element which may be operated to release the lock element such that the distance between the first guide surface and the second guide surface is no longer maintained.

8. The guide of claim 1, further comprising a connector wherein at least one of the first and second arms is flexibly joined to the connector and wherein the handle is operatively connected to the fists arm and second arm such that in a first configuration the first surface and second surface are spaced sufficiently far apart to allow the guide to be positioned over the apex of a spinous process and in a second configuration, the first surface and second surface are spaced sufficiently close together to be biased against the sides of the spinous process.

9. The guide of claim 1, wherein the guide is releasably connected to an implantable spinous process reinforcing element.

10. The guide of claim 1, wherein the guide comprises a releasable implantable mesh reinforcing element.

11. A kit for use in a procedure to reinforce a spinous process, the kit comprising:

a guide;

a reinforcing element;

and a surgical instrument;

wherein the surgical instrument has an insertion axis, a distal tip and a bore through which a flowable reinforcing material may be injected into the spinous process;

wherein the guide has a guide bore adapted to allow passage of the surgical instrument along the insertion axis; and

wherein the guide comprises a first guide surface and a second guide surface adapted to engage the spinous process and align the guide bore with the spinous process.

12. The kit of claim 11, wherein:

the reinforcing element is releasably connected to the guide such that the reinforcing element is positioned with respect to the spinous process when the first guide surface and the second guide surface engage the spinous process.

13. The kit of claim 11, wherein:

the reinforcing element is adapted to be inserted into the spinous process through the guide bore.

14. The kit of claim 11, wherein:

the reinforcing element is adapted to be placed around the spinous process.

15. The kit of claim 11, wherein:

the reinforcing element comprises one of a titanium clip;

a titanium tube, a titanium rod and a titanium screw.

16. The kit of claim 11 wherein:

the guide and the surgical instrument are sized so as to prevent insertion of the surgical instrument surgical through the guide into a spinal canal of the patient.

17. The kit of claim 11, wherein the guide comprises:

a handle comprising a first handle element connected to the first surface and a second handle element connected to the second surface such that the handle may be operated to cause the first surface and the second surface to be biased against the sides of the spinous process.

18. The kit of claim 11, wherein the guide comprises:

a spring element which biases the first side surface towards the second guide surface;

and wherein the handle is operative to increase the distance between the first guide surface and the second guide surface against the biasing of the spring element.

19. The kit of claim 11, wherein the guide comprises:

a handle is movably connected to the arms such that the distance between the first guide surface and the second guide surface is decreased when the handle is pushed towards the first arm and second arm.

20. The kit of claim 11, wherein the guide comprises:

a lock element which maintains the distance between the first guide surface and the second guide surface.

21. A method for strengthening a spinous process of a vertebra having a lamina wherein the method comprises:

(a) inserting a guide over the spinous process;

(b) operating the guide to grasp the spinous process;

(c) inserting a surgical instrument having a bore through the guide into the spinous process; and

(d) forcing a flowable reinforcing material through the tubular bore such that it flows into the spinous process.

22. The method of claim 21, wherein the guide comprises a first guide surface and a second guide surface and wherein:

step (a) includes positioning the first guide surface and the second guide surface adjacent first and second sides of a spinous process;

step (b) includes operating the guide such that the first guide surface and the second guide surface grasp the first and second sides of the spinous process.

23. The method of claim 21, wherein the guide further comprises a handle, a first guide surface and a second guide surface and wherein:

step (a) includes positioning the first guide surface and the second guide surface adjacent first and second sides of a spinous process;

step (b) includes operating the handle of the guide such that the first guide surface and the second guide surface grasp the first and second sides of the spinous process.

24. The method of claim 21, wherein the guide comprises a guide bore and wherein:

step (c) comprises inserting the surgical instrument through the guide bore.

25. The method of claim 21, wherein the guide comprises a first guide bore and a second guide bore and step (c) comprises inserting the surgical instrument through the first guide bore and wherein the method further comprises:

(d) removing the surgical instrument from the first guide bore;

(e) inserting the surgical instrument through the second guide bore; and

(f) forcing a flowable reinforcing material through the tubular bore such that it flows into the spinous process.

26. The method of claim 21, further comprising:

(e) inserting an implantable reinforcing element into the spinous process.

27. The method of claim 21, further comprising:

(e) placing, an implantable reinforcing element around the spinous process.

28. The method of claim 21, further comprising:

(e) placing an implantable reinforcincg element in contact with the spinous process;

(f) removing the guide, while the reinforcing element is retained in contact with the spinous process.

29. The method of claim 21, further comprising:

(e) operating the guide to release the spinous process.

30. The method of claim 28, wherein the guide further comprises a handle, a first guide surface and a second guide surface and wherein:

step (a) includes positioning the first guide surface and the second guide surface adjacent first and second sides of a spinous process;

step (b) includes operating the handle such that the first guide surface and the second guide surface grasp the first and second sides of the spinous process; and

step (e) includes operating the handle such that the first guide surface and the second guide surface release the first and second sides of the spinous process.

31. The method of claim 28, wherein the guide further comprises a handle, a lock, a first guide surface and a second guide surface and wherein:

step (a) includes positioning the first guide surface and the second guide surface adjacent first and second sides of a spinous process;

step (b) includes operating the handle such that the first guide surface and the second guide surface grasp the first and second sides of the spinous process; and

step (e) includes releasing the lock such that the first guide surface and the second guide surface release the first and second sides of the spinous process.