Devices and methods for selective surgical removal of tissue

• US 20060094976A1
• Filed: 10/15/2005
• Published: 05/04/2006
• 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.
• Granted Patent: US 7,738,968 B2
• Time in Patent Office: Days
• US Class Current: 600/547
• 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
• 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: 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 for protecting tissue adjacent to target anatomy in a patient, the method comprising:

placing a first device adjacent to the target anatomy;

advancing a backstop device through the first device, where the backstop device comprises a flexible barrier adapted to be reduced to fit within the first device and adapted to expand after exiting the first device;

placing the flexible barrier over the tissue adjacent to the target anatomy; and

locating a nerve using an electrode on the backstop device.

2. The method of claim 1, where placing the flexible barrier over the tissue adjacent to the target anatomy comprises expanding the flexible barrier within a neural foramen.

3. The method of claim 1, further comprising positioning a surgical instrument into the epidural space and separating the surgical instrument from the tissue adjacent to the target anatomy using the flexible barrier.

4. The method of claim 3, where the surgical instrument is selected from the group consisting of an electrosurgical device, a laser, a rasp, a ronguer, a grasper, a burr, a sander, a drill, a shaver, an abrasive device, and a probe.

5. The method of claim 3, further comprising remodeling the target anatomy using the surgical instrument.

6. The method of claim 5, further applying a medication or bioactive components to the target anatomy being remodeled.

7. The method of claim 6, where the medication or bioactive component is selected from a substance from the group consisting of steroids, procoagulants, bone wax, and adhesion barriers.

8. The method of claim 5, further comprising, prior to remodeling the target anatomy, sending electrical current through the tissue adjacent to the target anatomy or target anatomy to attempt to locate a nerve.

9. The method of claim 8, where sending electrical current comprises sending electrical current through a first surface of the flexible barrier to attempt to locate a nerve, where the first surface is adjacent to the surgical instrument.

10. The method of claim 8, where sending electrical current comprises sending electrical current through a second surface of the barrier to attempt to locate a nerve, where the second surface is opposite to the surgical instrument.

11. The method of claim 8, where sending electrical current comprises sending electrical current through the surgical instrument to attempt to stimulate a nerve.

12. The method of claim 8, further comprising monitoring the patient for neural stimulation in order to confirm placement of the surgical instrument.