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

• US 9,456,783 B2
• Filed: 04/15/2015
• Issued: 10/04/2016
• Est. Priority Date: 07/11/2001
• Status: Expired due to Term

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Blewett, Jeffrey J., Farquhar, Allen, Kaula, Norbert, Gharib, James E.
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US14/687,745
• Publication Number:
  US 20150216478A1
• Time in Patent Office: 538 Days
• US Class Current: 1/1
• 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 system for establishing an operative corridor for spinal surgery, comprising:

a plurality of sequential dilator cannulas deliverable through bodily tissue having neural structures in a selected path toward a targeted intervertebral disc of a spine, the plurality of sequential dilator cannulas including at least an inner dilator cannula and an outer dilator cannula configured to be guided over the previously delivered inner dilator cannula, at least the inner dilator cannula of the plurality of sequential dilator cannulas having a stimulation electrode positioned along a distal tip region to deliver a stimulation signal to the bodily tissue when the inner dilator cannula is positioned in the selected path toward the targeted intervertebral disc of the spine;

a nerve monitoring system comprising a control unit and a plurality of leg muscle sensor electrodes, the nerve monitoring system being configured to deliver an electrical stimulation signal to the stimulation electrode when said inner dilator cannula is positioned along the selected path toward the targeted intervertebral disc of the spine, the nerve monitoring system being configured to monitor electrical activity detected by the plurality of leg muscle sensor electrodes in response to the electrical stimulation signal output from the stimulation electrode of said inner dilator cannula, and the control unit of the nerve monitoring system comprising a display device that simultaneously displays both;

a numeric stimulation current threshold in units of milliAmps that changes in response to the detected electrical activity at one or more of said leg muscle sensor electrodes, and one of a plurality of different color-coded indicators, wherein the plurality of different color-coded indicators include a first color corresponding to a first fixed intermediate current amplitude range, a second color corresponding to a second fixed current amplitude range that is greater than the first fixed intermediate current amplitude range, and a third color corresponding to a third fixed current amplitude range that is less than the first fixed intermediate current amplitude range; and

a working corridor instrument deliverable over the outer dilator cannula of the plurality of sequential dilator cannulas toward the targeted intervertebral disc of the spine, wherein the working corridor instrument is configured to establish an operative corridor to the targeted intervertebral disc of the spine.

2. The system of claim 1, wherein the color-coded indicators comprise red, yellow, and green.

3. The system of claim 1, wherein the color-coded indicator on the display device corresponds with the range in which the determined threshold stimulation current amplitude is located so as to indicate nerve proximity between a surgical instrument and the spinal nerve.

4. The system of claim 1, wherein the first color is yellow and is set to a predetermined current range, wherein the second color is red and is set to a second predetermined current range, and wherein the third color is green and is set to a third predetermined current range.

5. The system of claim 1, wherein the nerve monitoring system displays neuromuscular response information indicative of nerve proximity that includes color associated with the stimulation current threshold.

6. The system of claim 1, wherein the nerve monitoring system displays neuromuscular response information indicative of nerve proximity that includes color associated with the stimulation current threshold selected from the group of green, yellow, and red.

7. The system of claim 1, wherein the nerve monitoring system displays neuromuscular response information indicative of nerve proximity that includes the color-coded indicator.

8. The system of claim 1, wherein the nerve monitoring system contemporaneously displays:

a graphic representation of locations of said leg muscle myotomes and an indication of nerve direction relative to inner dilator along with the numeric stimulation current threshold in units of milliAmps that changes in response to the detected electrical activity at one or more of said leg muscle sensor electrodes and the one of the plurality of different color-coded indicators.

9. The system of claim 1, wherein the nerve monitoring system displays a color indicative of at least one of nerve proximity and pedicle integrity.

10. The system of claim 1, wherein at least two of the first, second, and third ranges comprise a safe range and an unsafe range.

11. The system of claim 1, wherein the color-coded indicators comprise red, yellow, and green, wherein the nerve monitoring system contemporaneously displays:

a graphic representation of locations of said leg muscle myotomes and an indication of nerve direction relative to inner dilator along with the numeric stimulation current threshold in units of milliAmps that changes in response to the detected electrical activity at one or more of said leg muscle sensor electrodes and the one of the plurality of different color-coded indicators, wherein at least two of the first, second, and third ranges comprise a safe range and an unsafe range.

12. The system of claim 1, wherein the nerve monitoring system is configured to display the numeric stimulation current threshold and one of the plurality of different color coded indicators to a surgeon so that the surgeon may use avoid contact with neural tissue.

13. The system of claim 12, wherein the color-coded indicator on the display device corresponds with the range in which the determined threshold stimulation current amplitude is located so as to indicate nerve proximity between a surgical instrument and the spinal nerve.

14. The system of claim 13, wherein the first color is yellow and is set to a predetermined current range, wherein the second color is red and is set to a second predetermined current range, and wherein the third color is green and is set to a third predetermined current range.

15. The system of claim 14, wherein the nerve monitoring system displays neuromuscular response information indicative of nerve proximity that includes color associated with the stimulation current threshold.

16. The system of claim 14, wherein the nerve monitoring system displays neuromuscular response information indicative of nerve proximity that includes color associated with the stimulation current threshold selected from the group of green, yellow, and red.

17. The system of claim 14, wherein the nerve monitoring system displays neuromuscular response information indicative of nerve proximity that includes the color-coded indicator.

18. The system of claim 17, wherein the nerve monitoring system contemporaneously displays:

a graphic representation of locations of said leg muscle myotomes and an indication of nerve direction relative to inner dilator along with the numeric stimulation current threshold in units of milliAmps that changes in response to the detected electrical activity at one or more of said leg muscle sensor electrodes and the one of the plurality of different color-coded indicators.

19. The system of claim 18, wherein the nerve monitoring system displays a color indicative of at least one of nerve proximity and pedicle integrity.

20. The system of claim 19, wherein at least two of the first, second, and third ranges comprise a safe range and an unsafe range.