Devices and methods for tissue access

• US 7,963,915 B2
• Filed: 10/15/2005
• Issued: 06/21/2011
• Est. Priority Date: 10/15/2004
• Status: Expired due to Fees

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano, Inc. (Baxano Surgical, Inc.)
• Inventors: Bleich, Jeffery L.
• Primary Examiner(s): Barrett; Thomas C
• Assistant Examiner(s): LAWSON, MATTHEW JAMES
• Application Number:
  US11/251,186
• Publication Number:
  US 20060100651A1
• Time in Patent Office: 2,075 Days
• Field of Search: 623 1711- 1716, 606 79- 85, 606/279, 606/86.R, 606/103
• US Class Current: 600/184
• CPC Class Codes: A61B 17/149 Chain, wire or band saws
• 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 17/29 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: A61F 2/0045 : Support slings
• 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 of decompressing impinged neural and neurovascular tissue of a patient'"'"'s spine, the method comprising:

passing a guidewire from outside of a patient'"'"'s body at a first location, through a spinal neural foramen between a spinal nerve root or ganglia and a facet joint complex, and out of the patient'"'"'s body at a second location;

coupling a tissue abrasion device to the guidewire after passing the guidewire through the spinal neural foramen, wherein the tissue abrasion device comprises an elongate, flexible, ribbon-shaped body having an axial length and first and second surfaces each having a width and separated from each other by a thickness, wherein the axial length is greater than the width and the width is greater than the thickness, wherein the first surface is an abrasive surface extending along one side of the ribbon-shape body that is opposite to the second surface, and the second surface is a non-abrasive surface, the tissue abrasion device having a proximal end and a distal end; and

positioning the tissue abrasion device within the neural foramen using the guidewire, so that the abrasive surface of the tissue abrasion device faces the facet joint complex and the non-abrasive surface faces the spinal nerve root or ganglia;

wherein the coupling step further comprises coupling the tissue abrasion device to the proximal end of the guidewire from outside of the patient'"'"'s body, after advancing the guidewire into the body.

2. The method of claim 1, further comprising removing tissue using the tissue abrasion device.

3. The method of claim 1, further comprising pulling simultaneously on the end of the tissue abrasion device to tension the abrasive surface against the tissue to be abraded.

4. The method of claim 1, further comprising pulling alternately on the proximal and distal ends of the tissue abrasion device to move the abrasive surface against the tissue to be abraded, whereby tissue is removed.

5. The method of claim 4, wherein the step of pulling alternately either the proximal or distal end of the tissue abrasion device comprises pulling alternately from either the first location outside of the patient'"'"'s body or the second location outside of the patient'"'"'s body.

6. The method of claim 1, further comprising removing tissue using the tissue abrasion device and collecting the tissue between the abrasive surface and a protective surface behind the abrasive surface of the tissue abrasion device.

7. The method of claim 1, further comprising confirming the position of the tissue abrasion device using one or more electrodes coupled to a neural localization device.

8. The method of claim 1, wherein the step of coupling the tissue abrasion device to the guidewire comprises coupling the distal end of the tissue abrasion device to the proximal end of the guidewire.

9. The method of claim 1, wherein the step of positioning the tissue abrasion device within the neural foramen using the guidewire comprises pulling the tissue abrasion device within the neural foramen using the guidewire.

26. The method of claim 1, wherein the positioning step further comprises positioning the tissue abrasion device using the guidewire while the proximal end of the guidewire remains within the body.

27. The method of claim 1, further comprising reciprocating the tissue abrasion device to remove tissue while the abrasive surface remains within the patient'"'"'s body by alternately applying a manual pulling force to a distal handle at a distal end of the guidewire and applying a manual pulling force to a proximal handle a proximal end of the tissue abrasion device such that the distal handle and the proximal handle move in opposite directions with respect to the outside of the patient'"'"'s body.

10. A method of decompressing impinged neural and neurovascular tissue of a patient'"'"'s spine, the method comprising:

passing a guidewire from outside of a patient'"'"'s body at a first location, through a spinal neural foramen between a spinal nerve root or ganglia and a facet joint complex, and out of the patient'"'"'s body at a second location;

coupling a tissue abrasion device to the guidewire after passing the guidewire through the spinal neural foramen, wherein the tissue abrasion device comprises an elongate, flexible, ribbon-shaped body having an axial length and first and second surfaces each having a width and separated from each other by a thickness, wherein the axial length is greater than the width and the width is greater than the thickness, wherein the first surface is an abrasive surface extending along one side of the ribbon-shape body that is opposite to the second surface, and the second surface is a non-abrasive surface, the tissue abrasion device having a proximal end and a distal end;

and positioning the tissue abrasion device within the neural foramen using the guidewire, so that the abrasive surface of the tissue abrasion device faces the facet joint complex and the non-abrasive surface faces the spinal nerve root or ganglia; and

abrading and removing tissue by moving the abrasive surface against the tissue to be abraded, wherein the proximal end of the tissue abrasion device is pulled from the first location outside the patient'"'"'s body and the distal end of the tissue abrasion device is pulled from the second location outside the patient'"'"'s body;

wherein the coupling step further comprises coupling the tissue abrasion device to the proximal end of the guidewire from outside of the patient'"'"'s body, after advancing the guidewire into the body.

11. The method of claim 10, further comprising collecting tissue abraded by the tissue abrasion device between the abrasive surface and the non-abrasive surface of the tissue abrasion device.

12. The method of claim 10, further comprising confirming the position of the tissue abrasion device using one or more electrodes coupled to a neural localization device.

13. The method of claim 10, wherein the step of coupling the tissue abrasion device to the guidewire comprises coupling the distal end of the tissue abrasion device to the proximal end of the guidewire.

14. The method of claim 10, wherein the step of positioning the tissue abrasion device within the neural foramen using the guidewire comprises pulling the tissue abrasion device within the neural foramen using the guidewire.

28. The method of claim 10, wherein the abrading and removing step further comprises moving the abrasive surface while the proximal end of the guidewire remains within the body.

29. The method of claim 10, wherein the abrading and removing step further comprises reciprocating the abrasive surface to remove tissue while the abrasive surface remains within the patient'"'"'s body by alternately applying a manual pulling force to a distal handle at a distal end of the guidewire and applying a manual pulling force to a proximal handle a proximal end of the tissue abrasion device such that the distal handle and the proximal handle move in opposite directions with respect to the outside of the patient'"'"'s body.

15. A method of decompressing impinged neural and neurovascular tissue of a patient'"'"'s spine, the method comprising:

passing a guidewire from outside of a patient'"'"'s body at a first location, through a spinal neural foramen between a spinal nerve root or ganglia and a facet joint complex, and out of the patient'"'"'s body at a second location;

coupling a tissue abrasion device to the guidewire, wherein the tissue abrasion device comprises an elongate, flexible, ribbon-shaped body having an abrasive surface comprising a plurality of blades on one side and a protective surface behind the abrasive surface, the tissue abrasion device having a proximal end and a distal end, wherein the ribbon-shaped body has a width and a thickness and the width is greater than the thickness;

pulling the tissue abrasion device within the neural foramen using the guidewire, so that the abrasive surface of the tissue abrasion device faces the facet joint complex and the protective surface faces the spinal nerve root or ganglia;

abrading tissue by pulling alternately on the proximal and distal ends of the tissue abrasion device to move the abrasive surface against the tissue to be abraded; and

collecting tissue abraded by the tissue abrasion device between the abrasive surface and the protective surface of the tissue abrasion device;

wherein the coupling step further comprises coupling the tissue abrasion device to the proximal end of the guidewire from outside of the patient'"'"'s body, after advancing the guidewire into the body.

16. The method of claim 15, further comprising confirming the position of the tissue abrasion device using one or more electrodes coupled to a neural localization device.

17. The method of claim 15, wherein the step of coupling the tissue abrasion device to the guidewire comprises coupling the distal end of the tissue abrasion device to the proximal end of the guidewire.

18. The method of claim 15, wherein the step of positioning the tissue abrasion device within the neural foramen using the guidewire comprises pulling the tissue abrasion device within the neural foramen using the guidewire.

30. The method of claim 15, wherein the abrading step further comprises moving the abrasive surface while the proximal end of the guidewire remains within the body.

31. The method of claim 15, wherein the abrading step further comprises reciprocating the abrasive surface to remove tissue while the abrasive surface remains within the patient'"'"'s body by alternately applying a manual pulling force to a distal handle at a distal end of the guidewire and applying a manual pulling force to a proximal handle a proximal end of the tissue abrasion device such that the distal handle and the proximal handle move in opposite directions with respect to the outside of the patient'"'"'s body.

19. A method of removing tissue from a patient'"'"'s spine, the method comprising:

passing a guidewire from outside of a patient'"'"'s body at a first location, through a spinal neural foramen between a spinal nerve root or ganglia and a facet joint complex, and out of the patient'"'"'s body at a second location;

coupling a tissue abrasion device to the guidewire after passing the guidewire through the spinal neural foremen, wherein the tissue abrasion device comprises an elongate, flexible, ribbon-shaped body having an axial length and first and second surfaces each having a width and separated from each other by a thickness, wherein the axial length is greater than the width and the width is greater than the thickness, wherein the first surface has an abrasive element and the second surface is a non-abrasive surface that is opposite from the first surface, the tissue abrasion device having a proximal end and a distal end; and

positioning the tissue abrasion device within the neural foramen using the guidewire, so that the elongate body is between the spinal nerve root or ganglia and the facet joint complex and the abrasive surface faces the facet joint complex while the non-abrasive surface faces the spinal nerve root or ganglia;

wherein the coupling step further comprises coupling the tissue abrasion device to the proximal end of the guidewire from outside of the patient'"'"'s body, after advancing the guidewire into the body.

20. The method of claim 19, wherein the positioning step further comprising positioning the tissue abrasion device within the neural foramen using the guidewire, so that the abrasive element of the tissue abrasion device is adjacent to the facet joint complex.

21. The method of claim 19, further comprising abrading and removing tissue by moving the abrasive element against the tissue to be abraded, wherein the proximal end of the tissue abrasion device is pulled from the first location outside of the patient'"'"'s body and the distal end of the tissue abrasion device is pulled from the second location outside of the patient'"'"'s body.

22. The method of claim 21, wherein the step of abrading and removing further comprises abrading and removing tissue of the facet joint complex.

23. The method of claim 19, wherein the tissue abrasion device comprises an elongate protective surface.

24. The method of claim 19, wherein the tissue abrasion device further comprises an atraumatic railing coupled to the elongate body, wherein the railing is sized and configured to facilitate passage of the abrasion element.

25. The method of claim 19, wherein the tissue abrasion device comprises a second abrasive element.

32. The method of claim 19, wherein the positioning step further comprises positioning the tissue abrasion device using the guidewire such that the proximal end of the guidewire remains within the body.

33. The method of claim 19, further comprising reciprocating the tissue abrasion device to remove tissue while the abrasive surface remains within the patient'"'"'s body by alternately applying a manual pulling force to a distal handle at a distal end of the guidewire and applying a manual pulling force to a proximal handle a proximal end of the tissue abrasion device such that the distal handle and the proximal handle move in opposite directions with respect to the outside of the patient'"'"'s body.