Devices and methods for tissue modification

• US 7,740,631 B2
• Filed: 10/15/2005
• Issued: 06/22/2010
• 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., Hlavka, Edwin J.
• Primary Examiner(s): Dvorak; Linda C
• Assistant Examiner(s): SCOTT, AMANDA L
• Application Number:
  US11/251,204
• Publication Number:
  US 20060089640A1
• Time in Patent Office: 1,711 Days
• Field of Search: 606/92, 606 45- 49, 606 82- 85, 606/167, 606/170, 606/175, 606/176, 606/177, 606/79, 600/546, 600/544
• US Class Current: 606/79
• 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 surgical tissue modification device for use with a nerve stimulation apparatus, the tissue modification device comprising:

an elongate flexible body attachable;

at the distal end of the elongate flexible body to a guidewire so that the device can be positioned or actuated by pulling on the guidewire;

at least one tissue modification surface located on the body;

at least one electrode attached to the body; and

a connector for electrically coupling the electrode to the nerve stimulation apparatus,

wherein the device is configured to attach to the guidewire so that the tissue modification surface of the flexible body can be positioned or actuated by pulling on the guidewire from a distal end of the guidewire extending out of a patient'"'"'s body to urge the tissue modification surface against the target tissue.

2. The surgical tissue modification device of claim 1, further comprising at least one barrier located over a portion of the tissue modification surface.

3. The surgical tissue modification device of claim 2, where the barrier further comprises at least one window through which the tissue modification surface may contact tissue when the barrier is placed over the tissue modification surface.

4. The surgical tissue modification device of claim 2, where the barrier is slidable relative to the tissue modification surface.

5. The surgical tissue modification device of claim 2, where at least one electrode is located on the barrier.

6. The surgical tissue modification device of claim 2, where the at least one electrode comprises at least two electrodes, where the electrodes are located in at least one of the following combinations, one on each side of the flexible body, one on each side of the barrier, one on the tissue modification side of the flexible body and one on the opposite side of the barrier.

7. The surgical tissue modification device of claim 1, where the tissue modification surface is located on a first side of the flexible body and the electrode is located on the first side of the body.

8. The surgical tissue modification device of claim 1, where the tissue modification surface comprises a plurality of grooves.

9. The surgical tissue modification device of claim 1, where the tissue modification surface comprises a plurality of perforations.

10. The surgical tissue modification device of claim 1, where the flexible body comprises a shape selected from the group consisting of a flat shape, a ribbon shape, and a tubular shape.

11. The surgical tissue modification device of claim 1, further comprising at least one medication or bioactive component for delivery to the tissue located on the tissue modification surface.

12. The surgical tissue modification device of claim 11, where the medication or bioactive component is selected from the group consisting of steroids, procoagulants, bone wax, and adhesion barriers.

13. A surgical system for modifying target tissue in a patient, the system comprising:

an elongate, at least partially flexible body attachable to a guidewire, the elongate flexible body including a tissue modification surface and an atraumatic surface; and

a guidewire having a distal end,

wherein the elongate body is configured to attach the elongate body to the guidewire so that the tissue modification surface of the flexible body can be positioned or actuated by pulling on the guidewire, so that when a flexible portion of the body passes along a curved surface between the target tissue and non-target tissue, a distal end of the guidewire extending out of the body can be pulled to apply a distal tensioning force to urge the tissue modification surface against the target tissue.

14. A system as in claim 13, wherein the tissue modification surface comprises a plurality of tissue cutting members fixedly attached to the elongate body.

15. A system as in claim 13, wherein the tissue modification surface comprises one or more movable blades.

16. A system as in claim 13, wherein the elongate body comprises a guidewire lumen.

17. A system as in claim 13, wherein the elongate body comprises a device for fixedly coupling the guidewire with the elongate body.

18. A system for modifying target tissue in a spine of a patient, the system comprising:

an elongate, at least partially flexible body attachable to a guidewire;

a deployment system for advancing the flexible body from outside the patient, through an intervertebral foramen of the patient'"'"'s spine, and out of the patient, such that a flexible portion of the body passes along a curved path between the target tissue and non-target tissue, and such that tensioning force may be applied at or near opposite ends of the device to urge the flexible portion against the target tissue during a tissue modification procedure;

a tissue modification surface disposed along the flexible portion of the elongate body;

wherein the elongate body is attachable at the distal end of the elongate flexible body to a guidewire so that the device can be positioned or actuated by pulling on the guidewire from a distal end of the guidewire extending out of the patient'"'"'s body to urge the tissue modification surface against the target tissue; and

an atraumatic surface disposed along the flexible portion such that when the tissue modification surface faces the target tissue, the atraumatic surface faces non-target tissue.

19. A system as in claim 18, wherein the elongate body comprises:

a shaft, including the flexible portion of the body; and

a flexible guidewire attached to the shaft.