Waveform marker placement algorithm for use in neurophysiologic monitoring

• US 9,757,072 B1
• Filed: 02/11/2014
• Issued: 09/12/2017
• Est. Priority Date: 02/11/2013
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Urbalejo, Edward C
• Primary Examiner(s): Stout, Michael C
• Assistant Examiner(s): Kolderman, Nicholas E
• Application Number:
  US14/178,176
• Time in Patent Office: 1,309 Days
• Field of Search: 600554
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/40 Detecting, measuring or recording for evaluating the nervous system A61B5/4806, A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/7235 Details of waveform analysis A61B5/349 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]

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 method of performing neuromonitoring of a patient during a surgical procedure, said method comprising the steps of:

obtaining a raw waveform ready for processing, wherein said raw waveform is comprised of electrical response signals recorded by recording electrode resulting from a neuromonitoring stimulus provided to the patient wherein said neuromonitoring stimulus is initiated by a processing unit and delivered to a stimulus electrode via a stimulation source, wherein said electrical response signal is delivered to a recording channel, wherein said recording channel sends said electrical response signal to the processing unit, wherein said electrical response signals are comprised of valid neurophysiologic response signal components and invalid neurophysiologic response signal components;

generating a derived processed waveform by the processing unit comprised of a first set of potentially valid neurophysiologic response signal components within the raw waveform, wherein said derived processed waveform excludes a first set of invalid neurophysiologic response signal components within the raw waveform, wherein said derived processed waveform generated by the processing unit excludes noise components from the raw waveform and is generated by the processing unit from ascending peaks and descending peaks of the raw waveform, and wherein said first set of the potentially valid neurophysiologic response signal components is stored in a storage device;

identifying a second set of potentially valid neurophysiologic response signal components by said processing unit in the derived processed waveform, wherein the second set of potentially valid neurophysiologic response signal components is a subset of the first set of potentially valid neurophysiologic response signal components, by rejecting the signal components of the first set of potentially valid neurophysiologic response signal components that do not meet predetermined signal morphology criteria, wherein said predetermined signal morphology criteria is at least one of minimum signal rise time, maximum signal rise time, minimum signal amplitude, maximum signal amplitude, and minimum signal to noise ratio, and wherein said second set of potentially valid neurophysiologic response signal components is stored in said storage device;

searching the second set of potentially valid neurophysiologic response signal components by said processing unit to determine said valid neurophysiologic response signal components, wherein said valid neurophysiologic response signal components are determined based on the second set of potentially valid neurophysiologic response signal components that exceed the signal to noise ratio level by a predefined value;

displaying latency and amplitude marker locations on said raw waveform by said processing unit based on the location of said valid neurophysiologic response signal components, said latency and amplitude marker locations having an associated value;

measuring the value, at one of said marker locations, of at least one waveform characteristic, by said processing unit wherein said waveform characteristic is at least one of amplitude and latency;

comparing the value of said at least one measured waveform characteristic with a value of a baseline waveform characteristic to determine a difference between the values by said processing unit;

issuing a warning if the difference between the value of said at least one measured waveform characteristic and the value of the baseline waveform characteristic increases or decreases by a predetermined level by said processing unit.

2. The method of claim 1, wherein the generating a derived processed waveform further comprises the processing unit iteratively identifying negative and positive peaks in said raw waveform.

3. The method of claim 1, wherein the generating a derived processed waveform step by the processing unit further comprises the steps of:

(a) determining the value of the ascending peaks, the descending peaks, and the noise of the raw waveform;

(b) generating a derived average waveform based on the ascending peaks, the descending peaks, and the noise of the raw waveform, wherein said derived average waveform has ascending peaks and descending peaks;

(c) determining the value of the ascending peaks and the descending peaks of the derived average waveform; and

(d) comparing the values of the ascending peaks and the descending peaks of the raw waveform to the values of the ascending peaks and the descending peaks of the derived average waveform to generate the derived processed waveform.

4. The method of claim 1, wherein the step of identifying the second set of potentially valid neurophysiologic response signal components in the derived processed waveform comprises the processing unit rejecting the signal components of the first set of potentially valid neurophysiologic response signal components that do not meet at least two of minimum signal rise time, maximum signal rise time, minimum signal amplitude, maximum signal amplitude, and minimum signal to noise ratio.

5. The method of claim 1, wherein the step of identifying the second set of potentially valid neurophysiologic response signal components in the derived processed waveform comprises the processing unit rejecting the signal components of the first set of potentially valid neurophysiologic response signal components that do not meet at least four of minimum signal rise time, maximum signal rise time, minimum signal amplitude, maximum signal amplitude, and minimum signal to noise ratio.

6. The method of claim 1, wherein the searching step further comprises the processing unit using a reference signal having latency markers at designated times to develop a time period search window for searching the second set of potentially valid neurophysiologic response signal components.

7. The method of claim 1, further comprising the processing unit finding directional changes in said raw waveform.

8. The method of claim 1, further comprising the processing unit identifying noise spikes and calculating a noise level for said raw waveform.

9. The method of claim 1, further comprising the processing unit excluding an early latency portion of said raw waveform from a noise calculation to disqualify any stimulus artifact present at an onset of said raw waveform from entering into the noise calculation.

10. A system for providing neuromonitoring of a patient during a surgical procedure, comprising:

a control unit comprised of a main display and a processing unit,

a stimulation source,

a storage device, and

an electrode harness, wherein the control unit is configured to;

activate a stimulation signal in the electrode harness via the stimulation source;

receive a waveform from the patient recorded by the electrode harness, wherein the waveform is an electrical response signal, and in response to the stimulation signal, wherein said electrical response signal is comprised of valid neurophysiologic response signal components and invalid neurophysiologic response signal components;

identify a first set of potentially valid neurophysiologic response signal components within the waveform by said proceeding unit, wherein the processing unit processes said first set of potentially valid neurophysiologic response signal components to exclude a first set of invalid neurophysiologic response signal components of the waveform, wherein said first set of invalid neurophysiologic response signal components are excluded based on noise components and the ascending peaks and descending peaks of the waveform, and wherein said first set of potentially valid neurophysiologic response signal components are stored in the storage device;

perform a predictive waveform morphology search on the waveform by said processing unit to identify a second set of potentially valid neurophysiologic response signal components in the first set of potentially valid neurophysiologic response signal components that match neurophysiologic waveform morphology criteria and rejecting the signal components of the first set of potentially valid neurophysiologic response signal components that do not match neurophysiologic waveform morphology criteria, wherein said neurophysiologic waveform morphology criteria is at least one of minimum signal rise time, maximum signal rise time, minimum signal amplitude, maximum signal amplitude, and minimum signal to noise ratio, and wherein the second set of potentially valid neurophysiologic response signal components is a subset of the first set of potentially valid neurophysiologic response signal components;

search the second set of potentially valid neurophysiologic response signal components by said processing unit to determine said valid neurophysiologic response signals, wherein said valid neurophysiologic response signals are determined based on the second set of potentially valid neurophysiologic response signal components that exceed the signal to noise ratio level by a predefined value, and wherein said second set of potentially valid neurophysiologic response signal components are stored in the storage device;

determine the location where markers should be placed on the waveform by said processing unit based on the location of said valid neurophysiologic response signals within the waveform, wherein said determined marker location has an associated value;

place markers on the waveform by said processing unit;

compare the determined marker location value with a baseline waveform marker location value to determine a difference between the values by said processing unit; and

issue a warning if the difference between the determined marker location value and the baseline waveform marker location value increases or decreases by a predetermined level by the main display.

11. The system of claim 10, wherein the processing unit is further configured to calculate a noise level for the waveform.

12. The system of claim 10, wherein the waveform morphology criteria is at least three of signal rise type, signal rise time, signal amplitude and signal to noise ratio.

13. The system of claim 10, wherein, when a reference signal is available, the processing unit is further configured to:

create at least one target window search based on marker placement values in the reference signal; and

wherein the searching step searches the second set of potentially valid neurophysiologic response signal components in the at least one target window.

14. The system of claim 13, wherein, when a reference signal is not available, the processing unit is further configured to:

search, in the searching step, the second set of potentially valid neurophysiologic response signal components in a default window.

15. The system of claim 14, wherein the processing unit is further configured to:

narrow the default window by using marker locations from other waveforms of the patient.