Devices and methods for tissue access

• US 20060095028A1
• Filed: 10/15/2005
• Published: 05/04/2006
• 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.
• Application Number:
  US11/251,155
• Publication Number:
  US 20060095028A1
• Time in Patent Office: Days
• US Class Current: 606/39
• 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 to achieve access to target tissue in a patient, with minimal tissue damage, the method comprising:

advancing a cannulated access device into tissue at a first location;

inserting a portion of a cannulated instrument through the access device, where on exiting from the cannulated access device the portion of the cannulated instrument assumes a curved shape;

advancing the cannulated instrument until the curved portion of the cannulated instrument is immediately adjacent to the target anatomy;

inserting a sharp, substantially straight, flexible element through the curved portion of the cannulated instrument, where the flexible element substantially straightens upon exiting the from the curved portion of the cannulated instrument; and

advancing the flexible element, away from the target anatomy until a distal tip of the flexible element exits the patient at a second location.

2. The method of claim 1, where the cannulated instrument is preconfigured with a curved shape.

3. The method of claim 1, where the cannulated instrument is of a different shape than the cannulated access device.

4. The method of claim 3, where the cannulated access device is substantially straight and the cannulated instrument is substantially curved.

5. The method of claim 1, where the anatomy comprises spinal anatomy and where advancing the cannulated access device comprises advancing the cannulated access device in a substantially anterior direction.

6. The method of claim 5, where advancing the cannulated instrument comprises advancing the curved portion of the cannulated instrument around an anterior aspect facet joint by advancing the curved portion through a neural foramen.

7. The method of claim 2, where advancing the cannulated instrument comprises inserting the cannulated access device into the epidural space and then advancing the distal portion of the cannulated instrument through the neural foramen.

8. The method of claim 1, where the anatomy comprises spinal anatomy and where advancing the cannulated access device comprises advancing the cannulated access device laterally towards a medial side of a neural foramen and then advancing the instrument through the neural foramen.

9. The method of claim 1, further comprising advancing a tissue modifying device into the tissue at the first location, until a distal portion of the tissue modifying device extends out of the patient at the second location, while a proximal portion of the tissue modifying device remains extended out of the patient at the first location and modifying an anatomy in the patient with an intermediate working portion of the tissue modifying device.

10. The method of claim 9, further comprising advancing the second portion of the tissue modifying device out of the patient at the first location, where the first and second portions of the tissue modifying device extend out of the patient at substantially the first location.

11. The method of claim 9, where the working portion of the tissue modifying device comprises an element selected from the group consisting of an abrasion element, a cutting element, a shaving element, a rasp element, a filing element, an ablation element.

12. The method of claim 9, further comprising moving the working portion of the tissue modifying device across a portion of the anatomy to remove tissue.

13. The method of claim 9, further comprising coupling the tissue modifying device to an apparatus having a gear adapted to move the working portion of tissue modifying device.

14. The method of claim 9, further comprising simultaneously applying a force on both the distal and proximal portions of the tissue modifying device to create a force against the anatomy being modified.

15. The method of claim 9, further comprising inserting a first protective sleeve over the proximal portion of the tissue modifying device.

16. The method of claim 15, further comprising inserting a second protective sleeve over the distal portion of the tissue modifying device and advancing the second protective sleeve within the patient towards the first protective sleeve such that a gap between the first and second protective sleeves within the patient defines a surgical area.

17. The method of claim 15, where the first protective sleeve further includes at least one opening, where the method further comprises advancing the first protective sleeve towards the distal portion of the tissue modifying device, such that the opening in the protective sleeve defines a surgical area.

18. The method of claim 9, where advancing the tissue modifying device into the tissue at the first location comprises attaching the tissue modifying device to the flexible element and withdrawing the flexible element from the patient to pull the tissue modifying device into the patient.

19. The method of claim 9, where advancing the tissue modifying device into the tissue at the first location comprises advancing the tissue modifying device over the flexible element and out of the patient.

20. The method of claim 1, where the cannulated access device comprises more than one lumen.

21. The method of claim 1, where the second location is substantially the same as the first location.

22. The method of claim 1, further comprising withdrawing the cannulated instrument from the target anatomy and advancing a second sharp, substantially straight, flexible element through the opposite side of the anatomy.

23. The method of claim 1, further comprising using a guidance system to assist in advancing the cannulated instrument until the curved portion of the cannulated instrument is immediately adjacent to the target anatomy, where the guidance system is selected from a group consisting of a portal, an endoscope, a fiberoptic visualization device, a ultrasound device, a catheter-based MRI device, an optical tomography device.

24. The method of claim 1, where the cannulated instrument is steerable.

25. The method of claim 1, where at least one of the cannulated access device or cannulated instrument are removed from the patient leaving the flexible element in place as a working platform.

26. A method to achieve access to target tissue in a patient, with minimal tissue damage, the method comprising:

inserting a cannulated instrument into the patient in a first direction, where a distal portion of the cannulated instrument is made to assume a curved shape in the patient to advance in a second direction;

advancing the curved distal portion of the cannulated instrument immediately adjacent to the target anatomy;

inserting a sharp, substantially straight, flexible element through the cannulated instrument, where the flexible element substantially straightens upon exiting from the curved portion of the cannulated instrument; and

advancing the flexible element away from the target anatomy until a distal tip of the flexible element exits the body.

27. The method of claim 26, where the cannulated instrument is steerable.

28. A method to access target tissue anatomy in a patient, with minimal tissue damage, the method comprising:

advancing a cannulated access device into tissue at a first location towards the targeted anatomy;

inserting a distal portion of an instrument through the cannulated access device, where on exiting the cannulated access device the distal portion assumes a curved shape;

advancing the distal portion of the instrument until immediately adjacent to the target anatomy;

substantially straightening the distal portion of the instrument;

advancing the substantially straightened distal portion of the instrument away from the target anatomy and out of the tissue until a distal tip of the instrument exits the body.

29. The method of claim 28, where the instrument comprises an instrument selected from the group consisting of a needle, an epidural catheter, and a steerable guidewire.

30. A method to achieve access to the epidural space of a patient whose spine contains tissue which impinges on a neural or neural vascular tissue, the method comprising:

advancing a cannulated access device having a sharp distal end to the epidural space;

inserting a cannulated instrument with a substantially blunt distal end through the cannulated access device,

advancing the distal end of the cannulated instrument out of the distal end of the cannulated access device and through a neural foramen and anterior to a facet joint;

inserting a element having a sharp distal end through the cannulated instrument; and

advancing the element out of the distal end of the cannulated instrument and away from the neural foramen until a distal tip of the flexible element exits the patient.