IP Library Granted Patent US 11,471,086
Granted Patent B2
US 11,471,086 · App. 16/530,925 · Granted Oct 18, 2022

Systems and methods for performing neurophysiologic monitoring

Inventors: Richard W. Schermerhorn (San Diego, CA); Eric Finley (San Diego, CA); Adam Azzara (San Diego, CA); Dmitry Novikov (San Diego, CA); James E. Gharib (San Diego, CA)
Assignee: NuVasive, Inc.
A61B5/24
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Quick Facts
Patent No.
US 11,471,086
App. No.
16/530,925
Granted
Oct 18, 2022
Kind
B2
Abstract

The present invention relates to a system and methods generally aimed at surgery. More particularly, the present invention is directed at a system and related methods for performing surgical procedures and assessments involving the use of neurophysiology.

Claims (36)

1. An apparatus for performing somatosensory evoked potential monitoring during surgery, comprising:

a control unit, said control unit being configured to:

receive evoked somatosensory response data based on transmission of a plurality of electrical stimulation signals to a peripheral nerve of a patient;

increase a number of allowed evoked somatosensory responses from the evoked somatosensory response data by modifying a noise rejection threshold until the evoked somatosensory response data have a rejection rate that is less than a predetermined rejection rate value;

evaluate a plurality of latency values corresponding to the allowed evoked somatosensory responses from the evoked somatosensory response data;

based on (i) the evaluation satisfying a stability threshold and (ii) a comparison of an amplitude value of the evoked somatosensory response data to an amplitude value of the modified noise rejection threshold, refining at least one stimulation signal parameter that corresponds to at least one of the plurality of electrical stimulation signals; and

direct transmission of subsequent electrical stimulation signals using the at least one refined stimulation signal parameter.

2. The apparatus of claim 1 , wherein the control unit is further configured to receive instructions from a user to modify the at least one stimulation signal parameter.

3. The apparatus of claim 1 , wherein the at least one stimulation signal parameter is at least one of stimulation rate, current, pulse width, and polarity.

4. The apparatus of claim 3 , wherein the control unit is further configured to refine the at least one stimulation signal parameter automatically.

5. The apparatus of claim 4 , wherein the control unit is further configured to perform a threshold hunting algorithm to refine the subsequent electrical stimulation signals.

6. The apparatus of claim 1 , wherein the control unit is further configured to perform at least one of stimulated electromyography and motor evoked potential assessments.

7. The apparatus of claim 1 , wherein the control unit is further configured to generate an alert and provide instructions to display a cause for an alert condition to a user.

8. The apparatus of claim 7 , wherein the cause for the alert condition relates to at least one of anesthetic, cortical ischemia, muscle activity artifact, mechanical insult, and an electrode issue.

9. The apparatus of claim 7 , wherein the cause for the alert condition is at least partially attributable to ischemia of at least one of the spinal cord and brain of the patient.

10. The apparatus of claim 7 , wherein the cause for the alert condition is at least partially attributable to an electrode issue, and the optimal noise rejection threshold is at least 100 μV.

11. The apparatus of claim 7 , wherein the cause for the alert condition is at least partially attributable to a mechanical insult to the spinal cord of the patient.

12. The apparatus of claim 7 , wherein the cause for the alert condition is at least partially attributable to a degradation of a somatosensory response along at least one limb of the patient.

13. A method for performing somatosensory evoked potential monitoring during surgery, the method comprising:

receiving evoked somatosensory response data based on transmission of a plurality of electrical stimulation signals to a peripheral nerve of a patient;

increasing a number of allowed evoked somatosensory responses from the evoked somatosensory response data by modifying a noise rejection threshold until the evoked somatosensory response data have a rejection rate that is less than a predetermined rejection rate value;

evaluating a plurality of latency values corresponding to the allowed evoked somatosensory responses from the evoked somatosensory response data;

based on (i) the evaluation satisfying a stability threshold and (ii) a comparison of an amplitude value of the evoked somatosensory response data to an amplitude value of the modified noise rejection threshold, refining at least one stimulation signal parameter that corresponds to at least one of the plurality of electrical stimulation signals; and

directing transmission of subsequent electrical stimulation signals using the at least one refined stimulation signal parameter.

14. The method of claim 13 , wherein the at least one stimulation signal parameter is at least one of stimulation rate, current, pulse width, and polarity.

15. The method of claim 14 , wherein refining the at least one stimulation signal parameter comprises refining the at least one stimulation signal parameter automatically.

16. The method of claim 15 , wherein refining the at least one stimulation signal parameter comprises performing a threshold hunting algorithm to refine the subsequent electrical stimulation signals.

17. A method for performing somatosensory evoked potential monitoring during surgery, the method comprising:

receiving evoked somatosensory response data based on transmission of a plurality of electrical stimulation signals to a peripheral nerve of a patient;

increasing a number of allowed evoked somatosensory responses from the evoked somatosensory response data by modifying a noise rejection threshold until the evoked somatosensory response data have a rejection rate that is less than 30%;

evaluating a plurality of latency values corresponding to the allowed evoked somatosensory responses from the evoked somatosensory response data;

based on (i) the evaluation satisfying a stability threshold and (ii) a comparison of an amplitude value of the evoked somatosensory response data to an amplitude value of the modified noise rejection threshold, refining at least one stimulation signal parameter that corresponds to at least one of the plurality of electrical stimulation signals; and

directing transmission of subsequent electrical stimulation signals using the at least one refined stimulation signal parameter.

18. The method of claim 17 , wherein the at least one stimulation signal parameter is at least one of stimulation rate, current, pulse width, and polarity.

19. The method of claim 18 , wherein refining the at least one stimulation signal parameter comprises refining the at least one stimulation signal parameter automatically.

20. The method of claim 19 , wherein refining the at least one stimulation signal parameter comprises performing a threshold hunting algorithm to refine the subsequent electrical stimulation signals.

Assignments (2)
SECURITY INTEREST Recorded Feb 28, 2020
From: NUVASIVE, INC.; NUVASIVE CLINICAL SERVICES MONITORING, INC.; NUVASIVE CLINICAL SERVICES, INC.; NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 052918/0595 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 13, 2019
From: SCHERMERHORN, RICHARD W.; FINLEY, ERIC; AZZARA, ADAM; NOVIKOV, DMITRY; GHARIB, JAMES E.
To: NUVASIVE, INC.
Reel/Frame 050040/0330 →
Continuity (4)
Continuation 14856525 · Sep 16, 2015
Provisional Application 62136760 · Mar 23, 2015
Provisional Application 62051141 · Sep 16, 2014
Related Publication 20190350473A1 · Nov 21, 2019