Systems and methods for performing neurophysiologic monitoring

• US 10,420,480 B1
• Filed: 09/16/2015
• Issued: 09/24/2019
• Est. Priority Date: 09/16/2014
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Schermerhorn, Richard W., Finley, Eric, Azzara, Adam, Novikov, Dmitry, Gharib, James E.
• Primary Examiner(s): Towa, Rene T
• Application Number:
  US14/856,525
• Time in Patent Office: 1,469 Days
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

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

1. A system for performing somatosensory evoked potential monitoring during surgery, comprising:

a stimulator configured to deliver a plurality of electrical stimulation signals to a peripheral nerve of a patient;

at least one sensor configured to detect somatosensory response data evoked by said electrical stimulation signals to said peripheral nerve; and

a control unit in communication with said stimulator and said at least one sensor, said control unit being configured to;

direct transmission of the stimulation signals,

receive the evoked somatosensory response data based on the directed transmission of the stimulation signals from said at least one sensor, determine a rejection rate of the evoked somatosensory response data that are outside an optimal noise rejection threshold,

determine that the rejection rate exceeds a predetermined rejection rate value,

wherein the predetermined rejection rate value corresponds to a first number of evoked somatosensory responses inside the optimal noise rejection threshold, based on the determination that the rejection rate exceeds the predetermined rejection rate value, modify the optimal noise rejection threshold until the evoked somatosensory response data have a rejection rate that is less than the predetermined rejection rate value, wherein modification of the optimal noise rejection threshold corresponds to a second number of evoked somatosensory responses inside the optimal noise rejection threshold, wherein the second number of evoked somatosensory responses is greater than the first number of evoked somatosensory responses,

evaluate a plurality of latency values corresponding to the evoked somatosensory response data that have a rejection rate less than the predetermined rejection rate value,

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 optimal noise rejection threshold, optimize at least one stimulation signal parameter that corresponds to at least one of the plurality of electrical stimulation signals, wherein satisfying the stability threshold is based on a measurement in movement between at least two waveforms generated on a graphical user interface, wherein the at least two waveforms correspond to a subset of the evaluated plurality of latency values, and

direct transmission of new stimulation signals using the at least one optimized stimulation signal parameter.

2. The system of claim 1, wherein said at least one sensor is further configured to detect cortical and subcortical responses and wherein the control unit is further configured to determine a latency difference and an amplitude difference for each of the cortical and subcortical responses.

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

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

5. The system of claim 4, wherein the control unit is further configured to optimize the stimulation signal parameters automatically.

6. The system of claim 5, wherein the control unit is further configured to perform a threshold hunting algorithm to optimize the stimulation signals.

7. The system of claim 6, wherein the threshold hunting algorithm performs the determining and modifying steps.

8. The system of claim 1, wherein the control unit is further configured to perform at least one of stimulated EMG and MEP assessments.

9. A system for performing somatosensory evoked potential monitoring during surgery, comprising:

a stimulator configured to deliver a plurality of electrical stimulation signals to a peripheral nerve of a patient;

at least one sensor configured to detect somatosensory response data evoked by said electrical stimulation signals to said peripheral nerve; and

a control unit in communication with said stimulator and said at least one sensor, said control unit being configured to;

direct transmission of the stimulation signals,

receive the evoked somatosensory response data based on the directed transmission of the stimulation signals from said at least one sensor,

determine a rejection rate of the evoked somatosensory response data that are outside an optimal noise rejection threshold,

determine that the rejection rate exceeds a predetermined rejection rate value, wherein the predetermined rejection rate value corresponds to a first number of evoked somatosensory responses inside the optimal noise rejection threshold, based on the determination that the rejection rate exceeds the predetermined rejection rate value, modify the optimal noise rejection threshold until the evoked somatosensory response data have a rejection rate that is less than 30%, wherein modification of the optimal noise rejection threshold corresponds to a second number of evoked somatosensory responses inside the optimal noise rejection threshold, wherein the second number of evoked somatosensory responses is greater than the first number of evoked somatosensory responses,

evaluate a plurality of latency values corresponding to the evoked somatosensory response data that have a rejection rate less than 30%,

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 optimal noise rejection threshold, optimize at least one stimulation signal parameter that corresponds to at least one of the plurality of electrical stimulation signals, wherein satisfying the stability threshold is based on a measurement in movement between at least two waveforms generated on a graphical user interface, wherein the at least two waveforms correspond to a subset of the evaluated plurality of latency values, and

direct transmission of new stimulation signals using the at least one optimized stimulation signal parameter.

10. The system of claim 9, wherein the control unit is further configured to determine whether there is a change in the somatosensory response.

11. The system of claim 10, wherein the control unit is further configured to generate an alert and display a cause for an alert condition to a user.

12. The system of claim 11, 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.

13. The system of claim 11, wherein the cause for the alert condition is at least partially attributable to ischemia of at least one of the spinal cord and brain.

14. The system of claim 11, wherein the cause of the alert condition is at least partially attributable to an electrode issue, and the optimal noise rejection threshold is at least 100 μ

V.

15. The system of claim 11, wherein the cause of the alert condition is at least partially attributable to a mechanical insult to the spinal cord.

16. The system of claim 11, wherein the cause for the alert condition is at least partially attributable to a degradation of the somatosensory response along at least one limb.

17. The system of claim 9, wherein the control unit is further configured to determine whether a change in the somatosensory response is clinically significant.