Devices and methods for selective surgical removal of tissue

• US 7,738,968 B2
• Filed: 10/15/2005
• Issued: 06/15/2010
• 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.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US11/250,332
• Publication Number:
  US 20060094976A1
• Time in Patent Office: 1,704 Days
• Field of Search: 600/547, 600/554, 600/373, 600/562, 600/564, 600/570, 606/37, 606/39, 606/53, 607/43, 607116-118
• US Class Current: 607/117
• 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 for protecting neural and neurovascular tissue within a neural foramen of a patient'"'"'s spine adjacent to target anatomy, the method comprising:

placing a first device adjacent to the target anatomy;

advancing a protective barrier through the first device, where the protective barrier comprises a thin, flat, and flexible barrier surface configured to form a mechanical backstop that is adapted to be reduced to fit within the first device and adapted to expand after exiting the first device;

placing the flexible barrier over neural and neurovascular tissue in the neural foramen adjacent to the target anatomy so that the barrier surface of the protective barrier forms a backstop between target anatomy and neural and neurovascular tissue in the neural foramen; and

locating a nerve using an electrode on the protective barrier.

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

3. The method of claim 1, further comprising positioning a surgical instrument between the protective barrier and the target anatomy so that neural and neurovascular tissue adjacent to the target anatomy is protected from the surgical instrument by the flexible barrier.

4. The method of claim 3, where the surgical instrument is selected from the group consisting of an electro surgical 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 comprising applying a medication or bioactive component to the target anatomy being remodeled.

7. The method of claim 6, where the medication or bioactive component is selected 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, applying electrical current to locate a nerve.

9. The method of claim 8, where the step of applying electrical current comprises applying electrical current from an electrode located on a side of the protective barrier that faces neural and neurovascular tissue adjacent to the target anatomy to locate a nerve.

10. The method of claim 8, where the step of applying electrical current comprises applying electrical current from an electrode located on a side of the protective barrier that faces the target anatomy to locate a nerve.

11. The method of claim 8, where the step of applying electrical current comprises applying electrical current from an electrode on the surgical instrument to locate a nerve.

12. The method of claim 8, further comprising monitoring the patient for neural stimulation.

13. A method for protecting neural and neurovascular tissue within a spinal neural foramen adjacent to target anatomy in a patient, the method comprising:

placing a first device adjacent to the target anatomy;

advancing a protective barrier comprising a thin, flat and flexible barrier surface configured to form a mechanical backstop through the first device in a collapsed state;

expanding the protective barrier surface over neural or neurovascular tissue in the neural foramen adjacent to the target anatomy to form a backstop between target anatomy and neural or neurovascular non-target anatomy;

positioning a tissue abrasion device between the target anatomy and the protective barrier; and

applying electrical current to stimulate a nerve within the tissue adjacent to the target anatomy.

14. A method for protecting tissue adjacent to target tissue in a patient, the method comprising:

accessing a neural foramina of a patient'"'"'s spine;

positioning a protective barrier within the neural foramina to protect a nerve or neurovascular tissue therein, wherein the protective barrier comprises a thin, fiat, and flexible barrier surface configured to form a mechanical backstop;

expanding the barrier surface of the protective barrier within the neural foramen so that one side of the barrier surface faces target tissue and an opposite side of the barrier surface faces non-target nerve or neurovascular tissue;

locating a nerve using an electrode on the protective barrier; and

positioning a surgical instrument adjacent to the barrier surface of the protective barrier so that the surgical instrument contacts the target tissue but is prevented from contacting non-target nerve or neurovascular tissue by the protective barrier.

15. The method of claim 14, wherein the step of positioning a surgical instrument comprises positioning an abrasive surgical device adjacent to the barrier surface of the protective barrier so that the abrasive surgical device contacts the target tissue but is prevented from contacting the non-target tissue by the protective barrier.

16. The method of claim 14, further comprising applying electrical current to determine a location of the nerve in the neural foramina relative to the barrier surface.

17. The method of claim 14, wherein the step of accessing the neural foramina comprises percutaneously accessing the neural foramina.