System and methods for determining nerve proximity, direction, and pathology during surgery

• US 8,634,904 B2
• Filed: 11/08/2011
• Issued: 01/21/2014
• Est. Priority Date: 07/11/2001
• Status: Expired due to Term

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Kaula, Norbert F., Blewett, Jeffrey J., Gharib, James, Farquhar, Allen
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US13/292,065
• Publication Number:
  US 20120109000A1
• Time in Patent Office: 805 Days
• Field of Search: 607/48, 607/46, 607/118, 600/546, 600/554
• US Class Current: 600/546
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/36 for stimulation
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin

Abstract

The present invention involves systems and methods for determining nerve proximity, nerve direction, and pathology relative to a surgical instrument based on an identified relationship between neuromuscular responses and the stimulation signal that caused the neuromuscular responses.

Claims

1. A method of establishing an operative corridor for spinal surgery, comprising:

mounting a plurality of sensors proximate to selected leg muscles;

activating a nerve monitoring system that outputs stimulation signals to at least one stimulation electrode on a dilator and that, in response to signals from the sensors, displays neuromuscular response information which is indicative of nerve proximity to the at least one stimulation electrode, the nerve monitoring system directing the application of the stimulation signals to the at least one stimulation electrode according to an algorithm configured to identify a stimulation threshold that evokes a predetermined neuromuscular response, the algorithm including a detection sequence and a monitoring sequence, wherein the detection sequence adjusts the amplitude of the stimulation signals until an initial bracket that contains the stimulation threshold is determined, the initial bracket including an initial upper boundary at which the predetermined neuromuscular response is evoked and an initial lower boundary at which the predetermined neuromuscular response is not evoked, the detection sequence further adjusting the amplitude of the stimulation signals to repeatedly bisect the initial bracket until a final bracket that contains the stimulation threshold is determined, the final bracket including a final upper boundary at which the predetermined neuromuscular response is evoked and a final lower boundary at which the predetermined neuromuscular response is not evoked, the final upper boundary and final lower boundary being separated by a predetermined width and the stimulation threshold being selected from the final bracket, and wherein the monitoring sequence repeatedly adjusts the amplitude of the stimulation signals between the final lower boundary and the final upper boundary to detect changes to the stimulation threshold;

advancing the dilator through body tissue having neural structures along a path to a targeted intervertebral disc of a spine;

while the dilator is positioned along the path to the spinal target site, viewing the neuromuscular response information indicative of nerve proximity on a display device of the nerve monitoring system;

advancing a plurality of sequential dilator cannulas along the selected path toward the targeted intervertebral disc of the spine;

advancing a working corridor instrument over an outermost dilator cannula of the plurality of sequential dilator cannulas toward the targeted intervertebral disc of the spine; and

establishing an operative corridor to the targeted intervertebral disc of the spine using the working corridor instrument.

2. The method of claim 1, further comprising inserting a guide wire through a lumen of the dilator after the dilator is advanced through the body tissue to the spinal target site so that the guide wire penetrates an annulus of an intervertebral disc of the spine.

3. The method of claim 1, further comprising inputting a setting for the stimulation signal pattern using a graphical user interface of the nerve monitoring system.

4. The method of claim 1, wherein the stimulation threshold is displayed on the display device as the indicator of nerve proximity.

5. The method of claim 4, wherein the nerve monitoring system contemporaneously displays the stimulation threshold and a spine image.

6. The method of claim 1, wherein the sensors are EMG electrodes that detect voltage responses from the selected muscles.

7. The method of claim 6, wherein the nerve monitoring system also displays EMG waveforms.

8. The method of claim 7, wherein the EMG waveforms displayed by the nerve monitoring system comprises the voltage waveforms for eight EMG response channels.

9. The method of claim 1, further comprising removing the dilator and the plurality of sequential dilators from the working corridor instrument prior to establishing the operative corridor to the spinal target site.

10. The method of claim 1, wherein the working corridor instrument comprises a cannula that defines an inner lumen.

11. The method of claim 1, wherein the at least one dilator of the plurality of sequential dilator cannulas includes a stimulation electrode that delivers stimulation signals to the body tissue and comprising the additional step of operating the nerve monitoring system while the at least one additional dilator is positioned along the path to the spinal target site.

12. The method of claim 1, wherein the nerve monitoring system reenters the detection sequence if a change to the stimulation threshold is detected during the monitoring sequence.

13. The method of claim 1, wherein a color associated with the determined stimulation threshold is displayed as the indicator of nerve proximity.

14. The method of claim 13, wherein the color is one of red, yellow, and green.

15. The method of claim 13, wherein the determined stimulation threshold is displayed contemporaneously with the color.