Access and tissue modification systems and methods

• US 8,568,416 B2
• Filed: 08/17/2012
• Issued: 10/29/2013
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Spinal Elements, Inc.
• Original Assignee: Baxano Surgical, Inc.
• Inventors: Schmitz, Gregory P., Wallace, Michael P., Chung, Winnie, Borgstrom, Amie R., Bleich, Jeffery L., Arcenio, Gregory B., Leguidleguid, Ronald, Leguidleguid, Roy, Bleam, Jefferey
• Primary Examiner(s): BOLES, SAMEH RAAFAT
• Application Number:
  US13/588,969
• Publication Number:
  US 20130053851A1
• Time in Patent Office: 438 Days
• Field of Search: 606/79, 606/85, 606/103, 606/110, 606/119, 606/131, 606/163, 606171-176, 606/167
• US Class Current: 606/79
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/149 Chain, wire or band saws
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1611 the two jaw elements being integral with respective elongate shaft elements
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1635 for grafts, harvesting or transplants
• 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 17/1757 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• 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 17/3468 : for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 17/683 : comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
• CPC Class Codes: A61B 17/7065 : Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 17/7068 : Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
• CPC Class Codes: A61B 17/7092 : for checking pedicle hole has correct depth or has an intact wall pedicle drill depth limiters A61B17/1626
• CPC Class Codes: A61B 17/842 : Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61B 17/8897 : Guide wires or guide pins
• CPC Class Codes: A61B 18/02 : by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/14 : Probes or electrodes therefor
• 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 18/20 : using laser
• CPC Class Codes: A61B 2017/00039 : Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• 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 2017/00349 : Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00469 : for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00477 : Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00557 : inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00986 : Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/0225 : flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/320004 : abrasive
• CPC Class Codes: A61B 2017/320008 : Scrapers
• 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 2017/320069 : for ablating tissue
• CPC Class Codes: A61B 2017/32007 : with suction or vacuum means
• CPC Class Codes: A61B 2018/0044 : Spinal cord
• CPC Class Codes: A61B 2018/00565 : Bone
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00595 : Cauterization
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1412 : Blade
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1465 : Deformable electrodes
• CPC Class Codes: A61B 2034/2048 : using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2090/0427 : Prevention of contact
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/1101 : Detecting tremor
• CPC Class Codes: A61B 5/389 : Electromyography [EMG]
• CPC Class Codes: A61B 5/395 : Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/407 : Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/7207 : of noise induced by motion artifacts
• 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 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0063 : Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61M 25/09041 : Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 25/0905 : extendable, e.g. mechanisms for extension
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 2001/0578 : having means for removal or extraction

Abstract

Described herein are methods and systems for precisely placing and/or manipulating devices within the body by first positioning a guidewire or pullwire. The device to be positioned within the body is coupled to the proximal end of the guidewire, and the device is pulled into the body by pulling on the distal end of the guidewire that extends from the body. The device may be bimanually manipulated by pulling the guidewire distally, and an attachment to a device that extends proximally, allowing control of both the proximal and the distal ends. In this manner devices (and particularly implants such as innerspinous distracters, stimulating leads, and disc slings) may be positioned and/or manipulated within the body. Guidewire exchange systems, devices and methods are also described. A guidewire may be exchanged between different surgical devices and may be releaseably or permanently coupled.

Claims

1. A method of treating a patient, the method comprising:

advancing a distal end of a guidewire into the patient'"'"'s body from a first site, advancing adjacent to a target tissue, and out of the body from a second site, while maintaining a proximal end of the guidewire outside the body at the first site;

coupling an end of the guidewire on or near a distal end of a first surgical device outside of the body by inserting the end of the guidewire into a channel at or near the distal end of the first surgical device;

pulling the guidewire to guide the first surgical device adjacent to the target tissue; and

withdrawing the first surgical device and end of the guidewire from the patient while maintaining the guidewire within the body and de-coupling the end of the guidewire from the surgical device;

coupling the end of the guidewire on or near a distal end of a second surgical device outside of the body by inserting the end of the guidewire into a channel at or near the distal end of the second surgical device.

2. The method of claim 1, wherein advancing the distal end of the guidewire comprises pushing a sharp distal end of the guidewire through the tissue, wherein the guidewire cuts the tissue as it is advanced.

3. The method of claim 1, wherein coupling the end of the guidewire on or near the distal end of the surgical device comprises coupling the end of the guidewire to the first or second surgical device with at least one coupling member.

4. The method of claim 1, wherein coupling the end of the guidewire on or near the distal end of the first surgical device comprises engaging a region at the distal end of the guidewire that is larger than a more proximal region of the guidewire with a channel on or in the surgical device.

5. The method of claim 1, wherein de-coupling the end of the guidewire from the first surgical device comprises rotating the end of the guidewire, the distal end of the first surgical device, or both, to release a shaped member from the channel.

6. The method of claim 1, further comprising urging the second surgical device against the target tissue by applying tension to either or both the portion of the second surgical device extending from the first site and the guidewire extending from the second site.

7. The method of claim 1, further comprising performing a surgical procedure on the target tissue using the surgical device.

8. The method of claim 7, wherein the step of performing a surgical procedure comprises reciprocating the surgical device by pulling on either or both of the second surgical device extending from the first site and the guidewire extending from the second site.

9. A method for guiding at least a portion of a surgical device to a desired position in a patient'"'"'s body, the method comprising:

advancing a sharp distal end of a guidewire into the patient'"'"'s body, and out of the body, while maintaining a proximal end of the guidewire outside the body, wherein the sharp distal end cuts through tissues of the patient'"'"'s body;

coupling the proximal end of the guidewire with at least one coupling member on or near a distal end of a first surgical device outside of the body by inserting the guidewire into a channel at or near the distal end of the first surgical device;

pulling the distal end of the guidewire to guide at least a portion of the surgical device to a desired position adjacent to the target tissue;

withdrawing the surgical device and distal end of the guidewire proximally from the patient while maintaining the guidewire within the body and de-coupling the proximal end of the guidewire from the surgical device;

coupling the proximal end of the guidewire with at least one coupling member on or near a distal end of a second surgical device outside of the body;

pulling the distal end of the guidewire to guide at least a portion of an abrasive surface of the second surgical device to a desired position adjacent to the target tissue.

10. A method for performing a procedure on a target tissue in a patient'"'"'s body, the method comprising:

coupling a proximal end of a guidewire with a coupling member on or near a distal end of a first surgical device outside of the body by inserting the proximal end of the guidewire into or near the distal end of the first surgical device;

pulling a distal end of the guidewire to guide at least a portion of the first surgical device to a desired position in the patient'"'"'s body;

performing a procedure on the target tissue by reciprocating the surgical device by applying tension to both a portion of the guidewire outside of the body and a proximal portion of the surgical device;

withdrawing the surgical device and proximal end of the guidewire from the patient leaving the guidewire within the patient;

de-coupling the proximal end of the guidewire from the surgical device, and coupling the proximal end of the guidewire on or near a distal end of a second surgical device outside of the body; and

pulling a distal end of the guidewire to guide at least a portion of the second surgical device to a desired position in the patient'"'"'s body, such that an abrasive portion of the second surgical device faces the target tissue.

11. The method of claim 10, further comprising coupling the proximal end of the guidewire on or near the distal end of the first surgical device by coupling the proximal end of the guidewire to the first surgical device with at least one coupling member.

12. The method of claim 10, further comprising coupling the proximal end of the guidewire on or near the distal end of the first surgical device by engaging a guidewire coupling member on the first surgical device with the proximal end of the guidewire.

13. The method of claim 10, wherein de-coupling the end of the guidewire from the first surgical device further comprises releasing a shaped member from a channel in the first surgical device.