Methods and apparatus for tissue modification

• US 7,887,538 B2
• Filed: 03/13/2006
• Issued: 02/15/2011
• Est. Priority Date: 10/15/2005
• Status: Active Grant

• Current Assignee: Mis Ip Holdings LLC, Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Spisak, Steven A., Saadat, Vahid, Bleich, Jeffery L., Ashley, John E.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): Bates; David W
• Application Number:
  US11/375,265
• Publication Number:
  US 20060241648A1
• Time in Patent Office: 1,800 Days
• Field of Search: 606/79, 606/213, 606 82- 85
• US Class Current: 606/79
• 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

A method for modifying tissue in a patient may involve one or more of the following steps: advancing at least a distal portion of at least one elongate, at least partially flexible tissue modification device into a patient and between one or more target tissues and one or more non-target tissues; positioning at least one tissue modifying member of the tissue modification device adjacent the target tissue such that the tissue modifying member(s) face the target tissue and do not face the non-target tissue; applying an anchoring force to the tissue modification device at or near the distal portion or a proximal portion of the device; applying a tensioning force to the tissue modification device at or near an opposite end of the device relative to the end to which anchoring force is applied, while maintaining the anchoring force, to urge the tissue modifying member(s) against the target tissue; and modifying the target tissue, using the tissue modifying member(s), while preventing the tissue modifying member(s) from extending significantly beyond the target tissue toward the proximal or distal portion of the tissue modification device during tissue modification.

Claims

1. A method for modifying tissue in a spine of a patient, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into the patient'"'"'s epidural space and between one or more target tissues and one or more non-target tissues;

positioning a tissue modifying portion of the tissue modification device adjacent the target tissue such that a tissue modifying member of the tissue modifying portion faces the target tissue and does not face the non-target tissue;

anchoring the distal portion of the tissue modification device relative to the patient from outside of the patient through an exit point out of the patient located apart from the location where the device was advanced into the patient;

applying a tensioning force to the tissue modification device from the proximal portion of the device to urge the tissue modifying portion of device against the target tissue; and

modifying the target tissue with the tissue modifying portion of the device, while the distal portion is fixed relative to the patient, preventing any portion of the tissue modification device from extending significantly further distally beyond the exit point of the patient during tissue modification.

2. A method as in claim 1, wherein the step of advancing comprises advancing the distal portion of the device into an intervertebral foramen.

3. A method as in claim 1, wherein modifying the target tissue comprises cutting the target tissue by moving a the tissue modifying member of the tissue modifying portion relative to the rest of the tissue modification device.

4. A method as in claim 1, wherein modifying the target tissue reduces impingement of the tissue on at least one of a spinal cord, a branching nerve, dorsal root ganglia, and vascular tissue in the spine.

5. A method as in claim 1, wherein advancing the tissue modification device comprises advancing the distal portion of the device outside the patient through the exit point located apart from a location where the device was advanced into the patient.

6. A method as in claim 1, wherein advancing the tissue modification device comprises advancing along or through at least one of a guidewire, a shield, one or more rails, a track, a groove, a flat guide member, a lumen, a slot and a partial lumen.

7. A method as in claim 1, wherein modifying the target tissue comprises at least one of cutting, ablating, dissecting, repairing, reducing blood flow in, shrinking, shaving, burring, biting, remodeling, biopsying, debriding, lysing, debulking, sanding, filing, planing, heating, cooling, vaporizing, delivering a drug to, and retracting the target tissue.

8. A method as in claim 1, wherein positioning the tissue modifying member prevents damage to the non-target tissue by facing the tissue modifying member(s) away from the non-target tissue.

9. A method as in claim 8, further comprising additionally protecting the non-target tissue by positioning at least one shield device coupled with the tissue modification device between the device and the non-target tissue.

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

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

12. A method as in claim 1, wherein the method comprises modifying tissue with multiple elongate, flexible devices advanced into the patient in series.

13. A method as in claim 1, wherein the method comprises modifying tissue with multiple elongate, flexible devices positioned in the patient at the same time.

14. A method as in claim 1, further comprising activating the at least one tissue modifying member to modify a defined length of tissue.

15. A method as in claim 14, further comprising keeping the tissue modification member in close proximity to the target tissue throughout tissue modification.

16. A method as in claim 14, wherein activating the tissue modifying member comprises translating at least one member distally and/or proximally.

17. A method as in claim 16, wherein at least one of a blade and an electrode is translated.

18. A method as in claim 14, wherein activating the tissue modifying member(s) causes them to modify target tissue in an area having a length of no more than 3 cm.

19. A method as in claim 14, wherein activating the tissue modifying member(s) causes them to translate no farther than about 3 cm proximally or distally.

20. A method for modifying tissue in a spine of a patient, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into the patient'"'"'s epidural space and between one or more target tissues and one or more non-target tissues;

positioning a tissue modifying portion of the tissue modification device adjacent the target tissue such that a tissue modifying member of the tissue modifying portion faces the target tissue and does not face the non-target tissue;

anchoring the distal portion of the tissue modification device relative to the patient from outside of the patient through an exit point out of the patient located apart from the location where the device was advanced into the patient;

applying a tensioning force to the proximal portion of the device, to urge the intermediate tissue modifying portion of device against the target tissue; and

cutting the target tissue by moving the tissue modifying member relative to rest of the tissue modifying portion of the tissue modification device while the distal portion is fixed relative to the patient preventing any portion of the tissue modification device from extending further distally beyond the exit point out of the patient.

21. A method for modifying tissue in a spine of a patient, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into an epidural space of the patient and between one or more target tissues and one or more non-target tissues;

positioning a tissue modifying portion of the tissue modification device adjacent the target tissue such that a tissue modifying member of the tissue modifying portion faces the target tissue and does not face the non-target tissue;

anchoring the tissue modification device relative to the patient from the flexible distal portion of the device so that the distal portion is fixed relative to the patient, preventing any portion of the tissue modification device from extending further distally beyond the exit point out of the patient;

applying a tensioning force to the tissue modification device from the proximal portion of the device to urge the tissue modifying portion of device against the target tissue; and

applying radiofrequency energy to the target tissue, using the tissue modifying member while the distal portion is anchored.

22. A method as in claim 21, wherein the step of advancing comprises advancing the flexible distal portion into an intervertebral foramen.

23. A method as in claim 21, wherein anchoring the tissue modification device comprises anchoring the distal portion of the device from outside the patient through an exit point on the patient'"'"'s skin, wherein the exit point is located apart from the entry point.

24. A method as in claim 23, wherein anchoring the tissue modification device comprises anchoring to the patient'"'"'s skin at or near the exit point.

25. A method as in claim 23, wherein anchoring the tissue modification device comprises deploying one or more anchoring members within the patient.

26. A method as in claim 21, wherein advancing the tissue modification device comprises advancing along or through at least one of a guidewire, a shield, one or more rails, a track, a groove, a flat guide member, a lumen, a slot and a partial lumen.

27. A method as in claim 21, further comprising protecting the non-target tissue by positioning at least one shield device coupled with the tissue removal device between the device and the non-target tissue.

28. A method as in claim 27, wherein positioning the at least one shield device comprises sliding the shield into position along the tissue modification device.

29. A method as in claim 27, wherein the at least one shield device is positioned between the target and non-target tissues before advancing the tissue modification device, and wherein the tissue modification device is advanced by sliding it along the at least one shield device.

30. A method as in claim 27, further comprising activating one or more blades of the tissue modification device or of an additional device positioned in the patient to further modify one or more target tissues.

31. A method as in claim 21, wherein applying the radiofrequency energy comprises applying at least one of monopolar and bipolar radiofrequency energy.

32. A method as in claim 31, wherein the target tissue is modified in an area having a length of no more than 3 cm.

33. A method for modifying tissue in a spine of a patient, the method comprising:

advancing a flexible distal portion of an elongate tissue modification device into an epidural space of the patient and between one or more target tissues and one or more non-target tissues;

positioning a tissue modifying portion of the tissue modification device adjacent the target tissue such that a tissue modifying member of the tissue modifying portion faces the target tissue and does not face the non-target tissue;

anchoring the tissue modification device relative to the patient from the flexible distal portion of the device so that the distal portion is fixed relative to the patient, preventing any portion of the tissue modification device from extending further distally beyond the exit point out of the patient; and

translating a first blade of the tissue modifying member to move it towards a second blade of the tissue modifying member to cut the target tissue, while the distal portion is anchored.