Devices and methods for tissue modification

• US 8,221,397 B2
• Filed: 04/22/2009
• Issued: 07/17/2012
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Hlavka, Edwin J.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US12/428,369
• Publication Number:
  US 20090204119A1
• Time in Patent Office: 1,182 Days
• Field of Search: 606/1, 606 32- 50, 606/79, 606/103, 606/108, 606/117, 606/167, 606/170, 600/101, 600/104, 600/210, 600/544, 600/546, 600/547, 604/272, 601/32
• US Class Current: 606/1
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• 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 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2017/3447 : Linked multiple cannulas
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61B 90/04 : Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin

Abstract

Methods and apparatus are provided for selective surgical removal of tissue. In one variation, tissue may be ablated, resected, removed, or otherwise remodeled by standard small endoscopic tools delivered into the epidural space through an epidural needle. The sharp tip of the needle in the epidural space, can be converted to a blunt tipped instrument for further safe advancement. The current invention includes specific tools that enable safe tissue modification in the epidural space, including a barrier that separates the area where tissue modification will take place from adjacent vulnerable neural and vascular structures. A nerve stimulator may be provided to reduce a risk of inadvertent neural abrasion.

Claims

1. A method for treating tissue, the method comprising:

advancing a tissue access instrument into a patient and toward a target tissue from a first location, around at least part of the target tissue, and percutaneously out of the patient from a second location, so that both ends of the tissue access instrument are external to the patient;

positioning a tissue modification device adjacent to the target tissue using the tissue access instrument;

identifying substantially adjacent neural tissue using a neural localization apparatus; and

modifying the target tissue with the tissue modification device.

2. The method of claim 1, wherein the target tissue comprises spinal tissue.

3. The method of claim 1, wherein the tissue access instrument is selected from the group consisting of:

a needle, a cannula, a sheath, and an endoscope.

4. The method of claim 1, wherein the tissue access instrument comprises a wire.

5. The method of claim 1, wherein the step of advancing the tissue access instrument comprises advancing a wire through a neural foramen and around the anterior aspect of a single facet joint complex of the patient'"'"'s spine.

6. The method of claim 1, wherein the step of positioning the tissue modification device comprises connecting the tissue modification device to an end region of the tissue access instrument and pulling the tissue access instrument to move the tissue modification device through a neural foramen and around the anterior aspect of a single facet joint complex of the patient'"'"'s spine.

7. The method of claim 1, wherein the step of positioning the tissue modification device comprises passing the tissue modification device over the tissue access instrument.

8. The method of claim 1, wherein the step of positioning the tissue modification device comprises passing the tissue modification device through the tissue access instrument.

9. The method of claim 1, further comprising applying tension to urge the tissue modification device against the target tissue.

10. The method of claim 1, wherein the step of modifying tissue comprises pulling on the end of the tissue access instrument extending from the second location to move the tissue modification device against the tissue.

11. The method of claim 1, wherein the step of modifying tissue comprises reciprocating the tissue modification device against the tissue.

12. The method of claim 1, further comprising applying a medication or bioactive component to the target tissue.

13. The method of claim 12, wherein the medication or bioactive component is selected from the group consisting of steroids, procoagulants, bone wax, and adhesion barriers.

14. The method of claim 1, wherein indentifying substantially adjacent neural tissue comprises electrically identifying adjacent neural tissue using the neural localization apparatus, wherein the neural localization apparatus comprises one or more electrically conductive elements.

15. The method of claim 1, further comprising positioning the neural localization apparatus adjacent to the target tissue using the tissue access instrument.

16. The method of claim 1, wherein identifying substantially adjacent neural tissue using the neural localization apparatus comprises using a visualization element.

17. A method for treating tissue in a patient'"'"'s spine, the method comprising:

advancing a wire into the patient from a first location, through a neural foramen, around the anterior aspect of a single facet joint complex of the spine, and percutaneously out of the patient from a second location;

identifying substantially adjacent neural tissue using a neural localization apparatus;

connecting a tissue modification device to the wire;

positioning the tissue modification device through the neural foramen and around the anterior aspect of the single facet joint complex using the wire; and

modifying tissue in the spine by moving the tissue modification device against the tissue.

18. The method of claim 17, wherein the step of positioning the tissue modification device comprises pulling the wire to position the tissue modification device.

19. The method of claim 17, wherein the step of positioning the tissue modification device comprises pushing the tissue modification device over the wire.

20. The method of claim 17, wherein the step of modifying tissue comprises pulling on the end of the wire extending from the second location to move the tissue modification device against the tissue.

21. The method of claim 17, wherein the step of modifying tissue comprises reciprocating the tissue modification device against the tissue.

22. The method of claim 17, wherein indentifying substantially adjacent neural tissue comprises electrically identifying adjacent neural tissue using the neural localization apparatus, wherein the neural localization apparatus comprises one or more electrically conductive elements.

23. The method of claim 17, further comprising positioning the neural localization apparatus adjacent to the target tissue using the wire.

24. A method for treating tissue, the method comprising:

advancing a wire along a path into a patient and toward a target tissue from a first location, around at least part of the target tissue, and percutaneously out of the patient from a second location, so that both ends of the wire are external to the patient;

confirming the path of the wire by identifying substantially adjacent neural tissue along the path using a neural localization apparatus;

pulling a tissue modification device so that it is adjacent to the target tissue using the wire; and

modifying the target tissue with the tissue modification device by moving the tissue modification device against the tissue.

25. The method of claim 24,wherein the step of pulling the tissue modification device adjacent to the target tissue comprises pulling on the end of the wire extending from the second location to pull the tissue modification device.

26. The method of claim 24, wherein the step of modifying tissue comprises reciprocating the tissue modification device against the tissue.

27. The method of claim 24, wherein confirming the path of the wire by identifying substantially adjacent neural tissue along the path comprises electrically identifying substantially adjacent neural tissue using the neural localization apparatus, wherein the neural localization apparatus comprises one or more electrically conductive elements.

28. The method of claim 24, further comprising positioning the neural localization apparatus adjacent to the target tissue using the wire.

29. A method for treating tissue in a patient'"'"'s spine, the method comprising:

advancing a tissue access instrument into the patient along a path from a first location, through a neural foramen, around the anterior aspect of a single facet joint complex of the spine, and percutaneously out of the patient from a second location;

confirming the path of the tissue access instrument by identifying substantially adjacent neural tissue along the path using a neural localization apparatus;

connecting a tissue modification device to the tissue access instrument;

positioning the tissue modification device using the tissue access instrument; and

modifying tissue in the spine by moving the tissue modification device against the tissue.

30. The method of claim 29, wherein the step of positioning the tissue modification device comprises pulling the tissue modification device using the tissue access instrument.

31. The method of claim 29, wherein the tissue access instrument is selected from the group consisting of:

a needle, a cannula, a sheath, and an endoscope.

32. The method of claim 29, wherein confirming the path of the wire by identifying substantially adjacent neural tissue along the path comprises electrically identifying substantially adjacent neural tissue using the neural localization apparatus, wherein the neural localization apparatus comprises one or more electrically conductive elements.

33. The method of claim 29, further comprising positioning the neural localization apparatus adjacent to the target tissue using the tissue access instrument.