Systems and methods for performing surgical procedures and assessments

• US 8,265,744 B2
• Filed: 08/16/2011
• Issued: 09/11/2012
• Est. Priority Date: 09/25/2001
• Status: Expired due to Term

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Gharib, James, Farquhar, Allen, Kaula, Norbert, Blewett, Jeffrey, Finley, Eric, Martinelli, Scot
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US13/210,977
• Publication Number:
  US 20110301631A1
• Time in Patent Office: 392 Days
• Field of Search: 600/546, 600/554, 606/32, 606/41, 607/115, 607/116, 607/177, 623/17.11
• US Class Current: 600/546
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• 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 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/0262 with a provision for protecting nerves
• CPC Class Codes: A61B 2034/2053 Tracking an applied voltage gradient
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 : Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36142 : for improving safety
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means

Abstract

The present invention involves systems and related methods for performing surgical procedures and assessments, including the use of neurophysiology-based monitoring to: (a) determine nerve proximity and nerve direction to surgical instruments employed in accessing a surgical target site; (b) assess the pathology (health or status) of a nerve or nerve root before, during, or after a surgical procedure; and/or (c) assess pedicle integrity before, during or after pedicle screw placement, all in an automated, easy to use, and easy to interpret fashion so as to provide a surgeon-driven system.

Claims

1. A system for forming a path to a spinal target site via a trans-psoas approach, comprising:

a dilating cannula having longitudinal axis, a distal end, a proximal end, and a length such that said proximal end extends beyond a skin surface when said distal end is positioned adjacent to said spinal target site via a trans-psoas approach to said spinal target site, said dilator being insulated along the entire length with the exception of at least one exposed electrical contact at said proximal end and an exposed stimulation electrode at said distal end, said stimulation electrode being exposed along only a radial portion of said distal end, said dilating cannula further including a reference mark viewable when said distal end of said dilating cannula is located between said skin surface and said spinal target site and indicative of the radial position of said exposed stimulation electrode.

2. The system of claim 1, wherein said stimulation electrode is positioned at an angle relative to said longitudinal axis.

3. The system of claim 2, wherein said angle is between 5 and 85 degrees.

4. The system of claim 1, further including a stimulation connector with a first end releasably attachable to said proximal end of said dilating cannula and a cable for establishing electrical communication between said stimulation connector and a nerve monitoring system, said first end establishing electrical communication between said at least one electrical contact of said dilating cannula and said connector when said stimulation connector is attached to said dilating cannula.

5. The system of claim 4, wherein said stimulation connector is a clamp.

6. The system of claim 1, further comprising a second dilating cannula that is slidable over the first dilating cannula.

7. The system of claim 6, wherein said second dilating cannula includes a longitudinal axis, a distal end, a proximal end, and a length, said second dilator being insulated along the entire length with the exception of at least one exposed electrical contact at said proximal end and an exposed stimulation electrode at said distal end, said stimulation electrode being exposed along only a radial portion of distal end, said second dilating cannula further including a reference mark viewable when said distal end of said second dilating cannula is located between said skin surface and said spinal target site and indicative of the radial position of said exposed stimulation electrode.

8. The system of claim 7, further including a stimulation connector having a first end attachable to said proximal end of each of said first dilating cannula and said second dilating cannula and a cable for establishing electrical communication between said stimulation connector and an electrical stimulator, said first end establishing electrical communication between said at least one electrical contact of said first dilating cannula or said second dialting cannula and said stimulation connector when said stimulation connector is attached to said first dilating cannula or said second dilating cannula.

9. The system of claim 8, further comprising a working corridor instrument that is slidable over the second dilating cannula to form a trans-psoas operative corridor to the spinal target site along said path created by said first dilating cannula.

10. The system of claim 4, further comprising a control unit operable to command delivery of an electrical stimulation signal from a stimulator in communication with said stimulation connector.

11. The system of claim 10, wherein said control unit is operable to receive user input regarding delivery of said stimulation signal and to display on a color display device neuromuscular response data detected in response to the stimulation signal.

12. The surgical system of claim 11, wherein the color display device of the control unit comprises a touchscreen device to receive the user input regarding delivery of a stimulation signal.

13. The surgical system of claim 11, wherein the neuromuscular response data displayed comprises a numeric stimulation threshold current level that indicates an amplitude of the stimulation current pulses required to evoke a neuromuscular response having an amplitude value greater than a predetermined value.

14. The surgical system of claim 13, wherein the control unit display also displays a color associated with the numeric stimulation threshold.

15. A surgical system for forming a path to a spinal target site via a trans-psoas approach, comprising:

a sequential dilation access system comprising a plurality of dilating cannulas to form a trans-psoas corridor between a skin surface and a targeted spine site, the plurality of dilating cannulas comprising an outer dilating cannula fitting over another of the dilating cannulas when advanced in a trans-psoas path toward the targeted spine site,

wherein a stimulation electrode is positioned on at least one of the dilating cannulas to deliver a stimulation signal for nerve monitoring proximate to a distal end of the dilating cannula when advanced in the trans-psoas path, the stimulation electrode being arranged in a fixed position relative to a longitudinal axis of the at least one dilating cannula such that the stimulation electrode rotates with the at least one dilating cannula when the at least one dilating cannula is rotated about the longitudinal axis.

16. The system of claim 15, wherein said stimulation electrode is positioned at an angle relative to said longitudinal axis of said at least one dilating cannula.

17. The system of claim 16, wherein said angle is between 5 and 85 degrees.

18. The system of claim 15, wherein said at least one dilating cannula includes a reference mark proximate a proximal end of the at least one dilating cannula that is indicative of the radial position of the stimulation electrode on the at least one dilating cannula.

19. The system of claim 15, wherein the plurality of dilating cannulas of the sequential dilation access system range in diameter from 6 mm to 30 mm.

20. The system of claim 15, wherein the length of each the plurality of dilating cannulas of the sequential dilation access system decreases with increasing diameter.

21. The system of claim 15, wherein at least one of the plurality of dilating cannulas includes depth markings to aid in gauging the depth to the surgical target site.

22. The system of claim 15, further including a working corridor instrument that is slidable over the outer dilating cannula, the working corridor instrument being configured to maintain a trans-psoas operative corridor to the targeted spine site after the plurality of dilating cannulas are removed from the working corridor.

23. The system of claim 22, wherein the working corridor instrument comprises a working cannula structure.