Flexible tissue rasp

• US 8,048,080 B2
• Filed: 05/04/2006
• Issued: 11/01/2011
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Agilent Technologies, Inc., Mis Ip Holdings LLC, Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Hlavka, Edwin J.
• Primary Examiner(s): Barrett; Thomas C.
• Assistant Examiner(s): BATES, DAVID W
• Application Number:
  US11/429,377
• Publication Number:
  US 20070123888A1
• Time in Patent Office: 2,007 Days
• Field of Search: 606/79, 606/82, 606/84, 606/85, 606/148, 606/86.R
• US Class Current: 606/82
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

Methods and devices are described for modifying tissue in a spine of a patient to treat or alleviate spinal stenosis. In one embodiment, a method may include: advancing at least a distal portion of an elongate tissue modification device into an epidural space and between target tissue and non-target tissue in the spine; positioning the tissue modification device so that at least one abrasive surface of the device faces target tissue and at least one non-abrasive surface faces non-target tissue; applying tensioning force at or near separate distal and proximal portions of the tissue modification device; and translating the tissue modification device back and forth while maintaining at least some tensioning force to abrade at least a portion of the target tissue with the at least one abrasive surface. Unwanted damage to the non-target tissue may be prevented via the at least one non-abrasive surface.

Claims

1. A method for modifying tissue in a spine of a patient to treat or alleviate spinal stenosis, the method comprising:

advancing a guidewire through an epidural space of the patient'"'"'s spine and bending the guidewire around the target tissue in the spine;

coupling the guidewire to a tissue modification device having an elongate body with a rigid section at the proximal end region and a flexible abrasive surface at the distal end region;

positioning the tissue modification device so that the tissue modification device forms a bend against the target tissue and the abrasive surface of the tissue modification device faces target tissue and a non-abrasive surface of the tissue modification device faces non-target tissue;

urging the abrasive surface of the tissue modification device against the target tissue by pulling on the distal end region of the tissue modification device and pulling on the proximal end region of the tissue modification device; and

translating the tissue modification device proximally and distally by moving a proximal handle in an opposite direction from a distal handle while urging the abrasive surface of the tissue modification device against the target tissue to abrade the target tissue with the abrasive surface.

2. A method as in claim 1, wherein positioning the tissue modification device comprises advancing at least the distal portion through at least one channel in the patient'"'"'s spine.

3. A method as in claim 2, wherein the at least one channel comprises an intervertebral foramen.

4. A method as in claim 3, wherein advancing the tissue modification device comprises advancing at least the distal portion between two adjacent vertebrae into the epidural space and through the intervertebral foramen between the same two adjacent vertebrae.

5. A method as in claim 3, wherein advancing the tissue modification device comprises advancing at least the distal portion between two adjacent vertebrae into the epidural space and through the intervertebral foramen between two different vertebrae.

6. A method as in claim 1, wherein translating the tissue modification device to abrade the target tissue comprises abrading at least one of ligament, tendon, tumor, cyst, cartilage, scar, osteophyte, bone and joint capsule tissue.

7. A method as in claim 1, wherein translating the tissue modification device to abrade the target tissue reduces impingement of the tissue on at least one of a spinal cord, a branching nerve, a dorsal root ganglion, and vascular tissue in the spine.

8. A method as in claim 1, wherein positioning the tissue modification device includes positioning at least one non-abrasive shield member to face the non-target tissue.

9. A method as in claim 8, wherein positioning the at least one shield member comprises sliding the shield member into position along the tissue modification device.

10. A method as in claim 8, wherein the at least one shield member is positioned between the target tissue and non-target tissue before positioning the tissue modification device, and wherein the tissue modification device is positioned by sliding it along the at least one shield member.

11. A method as in claim 8, wherein the shield member is disposed over a portion of the at least one abrasive surface and is advanced into the patient along with the rest of the tissue modification device.

12. A method as in claim 8, wherein at least one of a distal portion and a proximal portion of the shield member is anchored outside the patient, so as to remain substantially stationary while the tissue modification device is translated back and forth.

13. A method as in claim 1, further comprising removing debris from the patient'"'"'s spine through at least one lumen in the tissue modification device, using at least one of suction and irrigation.

14. A method as in claim 1, further comprising delivering an electrical stimulus through the tissue modification device to test positioning of the tissue modification device before abrading the tissue.

15. A method as in claim 14, further comprising observing the patient to determine if the electrical stimulus was delivered to nerve tissue.

16. The method of claim 1, wherein the step of translating the tissue modification device comprises abrading the target tissue to treat or alleviate spinal stenosis without removing significant amount amounts of vertebral bone, joint, or other support structures.

17. The method of claim 1, wherein the step of translating the tissue modification device comprises abrading the target tissue without cutting completely through the vertebral bone or joint.

18. The method of claim 1 further comprising coupling a handle to the guidewire while the guidewire is coupled to the tissue modification device.

19. The method of claim 1, wherein the step of urging the abrasive surface of the tissue modification device against the target tissue by pulling on the distal end region of the tissue modification device comprises pulling distally on the guidewire.

20. The method of claim 1, wherein the step of advancing the guidewire comprises advancing a guidewire through an epidural space of the patient'"'"'s spine and bending the guidewire around the target tissue in the spine so that the guidewire is bent against the target tissue.

21. A method for modifying tissue in a spine of a patient to treat or alleviate spinal stenosis, the method comprising:

advancing an introducer sheath into an epidural space of the patient'"'"'s spine;

advancing a guide device through the introducer sheath and between target tissue and non-target tissue in the spine;

advancing a guidewire through the guide device and bending the guidewire around the target tissue so that the distal portion extends out of the patient'"'"'s back;

coupling the guidewire to, a tissue modification device having an elongate body with a rigid section at the proximal end region and a flexible abrasive surface at the distal end region;

positioning the tissue modification device so that the tissue modification device forms a bend against the target tissue and an abrasive surface of the tissue modification device faces target tissue and a non-abrasive surface of the tissue modification device faces non-target tissue;

urging the tissue modification device against the target tissue by pulling on the guidewire and by separately pulling on the proximal portion of the tissue modification device;

and

translating the tissue modification device proximally and distally by moving a proximal handle in an opposite direction from a distal handle while urging the abrasive surface of the tissue modification device against the target tissue to abrade the target tissue with the abrasive surface.

22. A method as in claim 21, wherein advancing comprises advancing at least the distal portion through at least one channel in the patient'"'"'s spine.

23. A method as in claim 22, wherein the at least one channel comprises an intervertebral foramen.

24. A method as in claim 21, wherein the tissue modification member is housed within a shield member during advancement.

25. A method as in claim 21, wherein abrading the target tissue comprises abrading at least one of ligament, tendon, tumor, cyst, cartilage, scar, osteophyte, inflammatory bone and joint capsule tissue.

26. A method as in claim 21, wherein abrading the target tissue reduces impingement of the tissue on at least one of a spinal cord, a branching nerve, a dorsal root ganglion, and vascular tissue in the spine.

27. A method as in claim 21, further comprising removing debris from the patient'"'"'s spine using at least one of suction and irrigation.

28. A method as in claim 21, further comprising delivering an electrical stimulus through the tissue modification member to test positioning before abrading the tissue.

29. A method as in claim 28, further comprising observing the patient to determine if the electrical stimulus was delivered to nerve tissue.

30. The method of claim 21, wherein the step of translating the tissue modification device comprises abrading the target tissue to treat or alleviate spinal stenosis without removing significant amount amounts of vertebral bone, joint, or other support structures.

31. The method of claim 21, wherein the step of translating the tissue modification device comprises abrading the target tissue without cutting completely through the vertebral bone or joint.

32. The method of claim 21, further comprising coupling a handle to the guidewire.

33. A method for modifying tissue in a spine of a patient to treat or alleviate spinal stenosis, the method comprising:

advancing a guidewire through an epidural space of the patient'"'"'s spine and bending the guidewire around the target tissue in the spine;

coupling the guidewire to, a tissue modification device having an elongate body with a rigid section at the proximal end region and a flexible abrasive surface at the distal end region;

positioning the tissue modification device so that the tissue modification device forms a bend against the target tissue and the abrasive surface of the tissue modification device faces target tissue;

coupling a distal handle to the guidewire;

urging the abrasive surface of the tissue modification device against the target tissue by pulling on the distal handle on the guidewire and pulling on a proximal handle on the tissue modification device; and

translating the tissue modification device proximally and distally by moving the proximal handle in an opposite direction from the distal handle while urging the abrasive surface of the tissue modification device against the target tissue to abrade the target tissue with the abrasive surface.

34. A method for modifying tissue in a spine of a patient to treat or alleviate spinal stenosis, the method comprising:

advancing a tissue modification device into the spine, the tissue modification device having an elongate body with a rigid section at the proximal end region and a flexible distal end region with an abrasive surface;

positioning the tissue modification device against target tissue so that the flexible distal end region is bent by the target tissue to curve at least partially around the target tissue with the abrasive surface facing the target tissue and a non-abrasive surface facing non-target tissue;

urging the abrasive surface of the tissue modification device against the target tissue by pulling on the distal end region of the tissue modification device and pulling on the proximal end region of the tissue modification device; and

translating the tissue modification device proximally and distally by moving a proximal handle in an opposite direction from a distal handle while urging the abrasive surface of the tissue modification device against the target tissue to abrade the target tissue with the abrasive surface.