Devices and methods for tissue access

• US 20060122458A1
• Filed: 10/15/2005
• Published: 06/08/2006
• 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:
  US11/250,902
• Publication Number:
  US 20060122458A1
• Time in Patent Office: Days
• US Class Current: 600/101
• 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 2017/00907 for light
• 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: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• 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, e.g., for enlargement of diseased spinal structures, such as impinged lateral recesses and pathologically narrowed neural foramen. 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. Once the sharp tip of the needle is in the epidural space, it is converted to a blunt tipped instrument for further safe advancement. A specially designed epidural catheter that is used to cover the previously sharp needle tip may also contain a fiberoptic cable. Further embodiments of the current invention include a double barreled epidural needle or other means for placement of a working channel for the placement of tools within the epidural space, beside the epidural instrument. 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. In one variation, a tissue removal device is provided including a thin belt or ribbon with an abrasive cutting surface. The device may be placed through the neural foramina of the spine and around the anterior border of a facet joint. Once properly positioned, a medical practitioner may enlarge the lateral recess and neural foramina via frictional abrasion, i.e., by sliding the tissue removal surface of the ribbon across impinging tissues. A nerve stimulator optionally may be provided to reduce a risk of inadvertent neural abrasion. Additionally, safe epidural placement of the working barrier and epidural tissue modification tools may be further improved with the use of electrical nerve stimulation capabilities within the invention that, when combined with neural stimulation monitors, provide neural localization capabilities to the surgeon. The device optionally may be placed within a protective sheath that exposes the abrasive surface of the ribbon only in the area where tissue removal is desired. Furthermore, an endoscope may be incorporated into the device in order to monitor safe tissue removal. Finally, tissue remodeling within the epidural space may be ensured through the placement of compression dressings against remodeled tissue surfaces, or through the placement of tissue retention straps, belts or cables that are wrapped around and pull under tension aspects of the impinging soft tissue and bone in the posterior spinal canal.

Claims

1. A method of accessing a target tissue region within a spinal anatomy of a patient, the method comprising:

advancing an access device towards the tissue region, where the access device comprises an access device body having a sharp tip at a distal end thereof, the access device body further comprising a lumen extending therethrough and exiting out of the distal end at an opening;

changing the sharp tip to a blunted tip by at least partially extending a distal portion of a second device through the distal end of the access device body; and

further advancing the access device until the blunted tip reaches the target tissue region.

2. The method of claim 1, where the second device comprises a catheter having a blunting portion adapted to change the sharp tip of the access device body to the blunted tip, where after advancement out of the distal end of the access body, the blunting portion prevents the sharp tip from contacting tissue.

3. The method of claim 1, where changing the sharp tip to the blunted tip comprises expanding the distal portion of the second device.

4. The method of claim 1, where changing the sharp tip to the blunted tip comprises at least partially retracting the distal portion of the second device into or next to the access device lumen.

5. The method of claim 1, where the distal portion of the second device includes a cap that fits over the sharp tip and changing the sharp tip to the blunted tip comprises placing the cap over or near the sharp tip.

6. The method of claim 1, where the second device further includes a fiberoptic.

7. The method of claim 1, further comprising expanding at least one anchor mechanism within the spinal anatomy.

8. The method of claim 7, where the anchor mechanism expands to a diameter greater than a diameter of the access device body.

9. The method of claim 7, where the anchor mechanism is located on a portal type device, where the portal type device is slidably located over the access device.

10. The method of claim 7, further comprising a second anchor located at a tissue surface exterior to the patient.

11. The method of claim 1, further comprising using a guidance system to assist in advancing the access device, 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.

12. The method of claim 1, where the access device opening is located towards the distal end on a first side of the access device body;

the method further comprising aligning an instrument along the first side of the access device body; and

advancing the instrument in fixed alignment with the first side of the access device body, where the access device body prevents the instrument from moving out of alignment with the access device body, and where the distal end of the access device body prevents the instrument from contacting the tissue region.

13. The method of claim 12, further comprising treating the area adjacent to the tissue region with the instrument.

14. The method of claim 12, where the instrument comprises a device selected from the group consisting of radio frequency devices, lasers, rasps, ronguers, graspers, burrs, sanders, drills, shavers, visualization devices, guidewires and probes.

15. The method of claim 12, where the instrument further comprises a flexible flat distal section, where the flexible flat distal section is configured to be advanced through the lumen of the access device body and upon exiting from the access device body can expand to form a barrier.

16. The method of claim 12, further comprises placing at least two conductive elements in contact with the patient where at least one conductive elements is on the instrument.

17. The method of claim 16, further comprising attempting to localize a nerve with the conductive elements.

18. A method of accessing a target tissue region within a space in a patient, the method comprising:

advancing an access device into the space, where the access device comprises an access device body having a sharp tip at a distal end thereof, the access device body further comprising a lumen extending therethrough and exiting out of the distal end at an opening;

advancing a distal portion of a second device adapted to blunt the sharp tip of the access device through the access device and out of the distal end;

transforming the shape of the distal portion of the second device to blunt the sharp tip the transformed distal portion preventing the sharp tip from contacting tissue; and

further advancing the access device until the blunted tip substantially reaches the target tissue.

19. The method of claim 18, where the second device further includes a fiberoptic.

20. The method of claim 18, where transforming the shape of the distal portion of the second device comprises expanding the distal portion of the second device.