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

• US 8,050,769 B2
• Filed: 05/01/2009
• Issued: 11/01/2011
• Est. Priority Date: 07/11/2001
• Status: Expired due to Fees

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Blewett, Jeffrey, Kaula, Norbert F., Gharib, James, Farquhar, Allen
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US12/434,303
• Publication Number:
  US 20090209879A1
• Time in Patent Office: 914 Days
• Field of Search: 600/554, 600/546, 600/202, 607/48
• US Class Current: 607/48
• 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 surgical system for stimulating nerves and monitoring EMG responses to the nerve simulation, comprising:

a control unit configured to receive user input regarding delivery of a stimulation signal and configured to receive neuromuscular response data, the control unit including a color display device and being configured to compute information for output to the color display device, said information being indicative of two or more of;

nerve proximity, nerve direction, nerve pathology, stimulation level, EMG response data, pedicle integrity, advance or hold instructions, and instrument in use, wherein the color display device provides an evoked potentials display option that shows the voltage waveforms for a plurality of EMG response channels;

a connector module that comprises a plurality of EMG response channels and an electrical connection for at least one nerve stimulation instrument, the connector module having a wire connection to the control unit so that the connector module is positionable apart from the control unit;

a plurality of pairs of EMG electrodes connectable to the plurality of EMG response channels of the connector module, the EMG electrodes being mountable proximate to selected leg muscles;

a first stimulation instrument comprising a dilator tube and a stimulation element that delivers the stimulation signal proximate to a distal end of the dilator tube when the dilator tube is advanced through tissue in a path toward a spine; and

a second stimulation instrument comprising a pedicle probe that delivers the stimulation signal when advanced into a pedicle opening formed in the spine, wherein the pedicle probe comprises a probe tip member and handle with a user-actuatable button to activate the stimulation signal for delivery by the screw test probe.

2. The system of claim 1, further comprising one or more sequential dilator cannulas that are deliverable through the tissue in the path toward the spine.

3. The system of claim 1, further comprising an operative corridor instrument that is deliverable over the one or more sequential dilator cannulas when advanced toward the spine.

4. The system of claim 3, wherein the operative corridor instrument comprises a working cannula that defines a tubular corridor to access the spine when the working cannula is advanced to the spine.

5. The system of claim 1, wherein the stimulation element of the first stimulation instrument comprises an obturator arranged inside the dilator tube and equipped with one or more stimulation electrodes.

6. The system of claim 5, further comprising a guide wire that is insertable through the dilator tube when the obturator is removed from the dilator tube, the guide wire being insertable through the dilator tube and into an annulus of a disc of the spine.

7. The system of claim 5, wherein the connector module comprises eight EMG response channels.

8. The system of claim 7, wherein the plurality of pairs of EMG electrodes is eight pairs of EMG electrodes connectable to the eight EMG response channels.

9. The system of claim 8, further comprising an anode electrode to provide a return path for the stimulation signal and a common electrode.

10. The system of claim 1, wherein the control unit is configured to represent each of the plurality of EMG response channels on the color display device with a different color.

11. The system of claim 10, wherein the control unit is configured to indicate a preferred muscle location for each of the plurality of EMG electrodes on the color display device.

12. The system of claim 11, wherein the control unit is configured to indicate the preferred muscle location on the color display device using text associated with each channel.

13. The system of claim 11, wherein the control unit is configured to indicate the preferred muscle location on the color display device using an image of the human form.

14. The system of claim 10, wherein the control unit is configured to receive input of a selection of a channel tab associated with a specific EMG channel, and the control unit is configured to highlight on the color display device the preferred placement of the pair of EMG electrodes associated with the selected channel on an image of the human form and displays the name of the muscle monitored by the selected channel.

15. The system of claim 14, wherein the control unit is configured to output data for display on the color display device indicative of the spinal levels associated with the selected channel.

16. The system of claim 1, wherein the control unit further determines a relationship between stimulation signals and the neuromuscular response data to indicate at least one of nerve proximity, nerve direction, nerve pathology.

17. The system of claim 16, wherein the relationship determined is the threshold stimulation current required to evoke an EMG response greater than a predetermined minimum amplitude.

18. The system of claim 17, wherein the control unit automatically adjusts the magnitude of successive stimulation signals until the threshold stimulation current is determined.

19. The system of claim 18, wherein the control unit automatically adjusts the magnitude of successive stimulation signals by larger increments until a first bracket having a first width containing said threshold is determined, and thereafter automatically adjusts the magnitude of successive stimulation signals until a second bracket having a second width smaller than said first width and containing said stimulation threshold is determined.

20. The system of claim 19, wherein the predetermined minimum amplitude of the EMG response is 100 μ

V.

21. The system of claim 17, wherein the control unit is configured to output the value of the determined stimulation threshold for display on the color display device.

22. The system of claim 21, wherein the control unit displays a color determined by the threshold stimulation current determined.

23. The system of claim 22, wherein the control unit determines the threshold stimulation current for each of the plurality of EMG response channels.

24. The system of claim 23, wherein the control unit determines the threshold stimulation current on the EMG response channel having the lowest stimulation threshold current first.

25. The system of claim 1, wherein the color display comprises a touchscreen display.

26. The system of claim 25, wherein the touchscreen display is operable to receive user commands.

27. The system of claim 2, wherein at least one of the sequential dilator cannulas is connectable to the connector module and includes a stimulation element that delivers the stimulation signal proximate to a distal end of the at least one sequential dilator cannula when the at least one sequential dilator cannula is delivered through the tissue in the path toward the spine.