DEVICES AND METHODS FOR TISSUE MODIFICATION

• US 20100094231A1
• Filed: 12/14/2009
• Published: 04/15/2010
• Est. Priority Date: 10/15/2004
• Status: Abandoned Application

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L., Hlavka, Edwin J.
• Application Number:
  US12/637,447
• Publication Number:
  US 20100094231A1
• Time in Patent Office: Days
• US Class Current: 604/274
• 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 for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• 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 catheters A61B2017/22072
• 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 spinal stenosis, the method comprising:

advancing a wire from a first point outside of a patient and through at least one of the patient'"'"'s lateral recess, spinal neural foramina, or central canal of the spine, around at least part of a target tissue, and passing the distal end of the wire out of the patient from a second point, whereby both ends of the wire are external to the patient;

visually confirming that the spinal nerve nearest the target tissue is positioned anterior to the path of the wire using an image guidance member;

positioning a tissue modification device adjacent to the target tissue using the wire; and

modifying the target tissue with the tissue modification device.

2. The method of claim 1, wherein the step of visually confirming comprises visualizing using an image guidance member configured as a fiberoptic.

3. The method of claim 1, wherein the step of visually confirming comprises visually using an image guidance member configured for optical tomography, infrared or ultrasound.

4. The method of claim 1, wherein the step of visually confirming comprises visualizing using an image guidance member having a tip configured to create a space for improved perspective during visualization.

5. The method of claim 1, wherein the step of visually confirming comprises advancing the image guidance member within the patient'"'"'s epidural space along the same pathway through the patient as the wire.

6. The method of claim 1, wherein the step of advancing the wire comprises advancing the wire from the first point located laterally on the side of the patient'"'"'s body so that the wire exits from the second point located dorsally on the side of the patient'"'"'s body.

7. The method of claim 1, wherein the step of advancing the wire comprises advancing the wire from the first point located dorsally, on the back of the patient'"'"'s body so that the wire exits from the second point located laterally on the side of the patient'"'"'s body.

8. The method of claim 1, wherein the step of advancing the wire comprises percutaneously advancing the wire.

9. The method of claim 1, wherein the step of modifying the target anatomy tissue comprises using a tissue modification device selected from the group consisting of a radiofrequency device, a rasp, a ronguer, a grasper, a burr, a sander, a drill, a shaver, and an abrasive device.

10. The method of claim 1, wherein the step of visually confirming that the spinal nerves are positioned anterior to the path of the wire comprises visually confirming that the pathway of the wire passes posterior to the spinal nerve root or ganglion nearest the pathway of the wire.

11. The method of claim 1, wherein the step of visually confirming that the spinal nerves are positioned anterior to the path of the wire is performed before passing the distal end of the wire out of the patient from the second point.

12. The method of claim 1, further comprising advancing a tissue access instrument into the patient from the first point towards the target tissue;

wherein the step of advancing the wire comprises passing the wire through the tissue access instrument.

13. The method of claim 11, wherein the step of visually confirming that the spinal nerve nearest the target tissue is positioned anterior to the path of the wire comprises advancing the image guidance member through the tissue access instrument.

14. A method of treating spinal stenosis, the method comprising:

advancing a guidewire from a first point outside of a patient, towards a target tissue, through a spinal neural foramina and around at least part of the target tissue, and passing the distal end of the guidewire out of the patient from a second point, whereby both ends of the guidewire are external to the patient;

advancing an image guidance member towards the target tissue along the same pathway through the patient as the guidewire;

visually confirming that the pathway of the guidewire through the patient passes anterior to the facet joint complex but posterior to the nerve root or ganglion nearest the target tissue;

positioning a tissue modification device adjacent to the target tissue using the guidewire; and

modifying the target tissue with the tissue modification device.

15. The method of claim 14, wherein the step of visually confirming comprises visualizing using an image guidance member configured as a fiberoptic.

16. The method of claim 14, wherein the step of visually confirming comprises visualizing using an image guidance member having a tip configured to create a space for improved perspective during visualization.

17. The method of claim 14, wherein the step of advancing the guidewire comprises percutaneously advancing the guidewire.

18. The method of claim 14, wherein the step of visually confirming that the pathway of the guidewire through the patient passes anterior to the facet joint complex but posterior to the nerve root or ganglion nearest the target tissue is performed before passing the distal end of the guidewire out of the patient from the second point.

19. The method of claim 14, wherein the step of advancing the guidewire comprises advancing a tissue access instrument into the patient from the first point towards the target tissue and passing the guidewire through the tissue access instrument.

20. A method of treating spinal stenosis, the method comprising:

advancing a tissue access instrument into the patient from a first point outside of the patient and towards a spinal neural foramen;

advancing a wire through the tissue access instrument, towards a target tissue, through the spinal neural foramina and around at least part of the target tissue, and passing the distal end of the guidewire out of the patient from a second point, whereby both ends of the wire are external to the patient;

advancing an image guidance member along the tissue access instrument towards the target tissue;

visually confirming that the pathway of the wire through the patient passes anterior to the facet joint complex but posterior to the nerve root or ganglion nearest the target tissue;

positioning a tissue modification device adjacent to the target tissue using the guidewire; and

modifying the target tissue with the tissue modification device.

21. A method of treating spinal stenosis, the method comprising:

advancing a tissue access instrument into the patient from a first point outside of the patient and towards a spinal neural foramen;

visually confirming that the pathway of the tissue access instrument through the patient passes anterior to the facet joint complex but posterior to the nerve root or ganglion nearest the target tissue;

advancing a wire through the tissue access instrument, towards a target tissue, through the spinal neural foramina and around at least part of the target tissue, and passing the distal end of the guidewire out of the patient from a second point, whereby both ends of the wire are external to the patient;

positioning a tissue modification device adjacent to the target tissue using the guidewire; and

modifying the target tissue with the tissue modification device.

22. The method of claim 21, further comprising the step of advancing an image guidance member along the tissue access instrument towards the target tissue.