# US 10,869,616 B2 · Neural event detection

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- Number: US 10,869,616 B2
- Document ID: US10869616B2
- Status: Granted
- Kind: B2
- Application number: 15/995,879
- Filed: 2018-06-01
- Published: 2019-12-05
- Granted: 2020-12-22
- Earliest claimed: 2018-06-01
- Assignees: DePuy Synthes Products, Inc.
- Applicants: Depuy Synthes Products, Inc.
- Inventors: Christopher Wybo; Aashish Shah; Tarik Yardibi; Emir Osmanagic; Darren Scarfe
- Web page: https://patentgrep.com/patent/US10869616B2

## CPC

- A61B 5/1104: {induced by stimuli or drugs (A61B5/1102 takes precedence)}
- A61B 5/1107: {Measuring contraction of parts of the body, e.g. organ or muscle}
- A61B 5/4893: {Nerves}
- A61B 5/7203: {for noise prevention, reduction or removal}
- A61B 5/7267: {involving training the classification device}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/36135: {using physiological parameters}
- A61B 2505/05: Surgical care
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- A61B 2562/0261: Strain gauges
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A neural monitoring system for detecting an artificially-induced mechanical muscle response to a stimulus provided within an intracorporeal treatment area includes a mechanical sensor, a stimulator, and a processor. The processor is configured to provide a periodic stimulus via the stimulator, and monitor the output from the mechanical sensor in an expected response window that follows one stimulus, yet concludes before the application of the next, subsequent stimulus to determine if the stimulus induced a response of the muscle.

## Claims

### Claim 1

A neural monitoring system for detecting an artificially-induced mechanical response of a muscle to a stimulus provided within an intracorporeal treatment area of a human subject, the intracorporeal treatment area including a nerve that innervates the muscle, the neural monitoring system comprising:
a non-invasive mechanical sensor configured to be placed in mechanical communication with the muscle and to generate a mechanomyography output signal that corresponds to a sensed mechanical movement of the muscle;
a stimulator configured to provide a periodic stimulus within the intracorporeal treatment area, the periodic stimulus including at least a first stimulus beginning at a first time (T1), and a second, consecutive stimulus beginning at a second time (T2); and
a processor in communication with the mechanical sensor and the stimulator, the processor configured to:
provide the periodic stimulus to the stimulator;
receive the mechanomyography output signal from the mechanical sensor;
analyze a response window of the mechanomyography output signal to determine if the first stimulus induced a response of the muscle; and
provide an indication to a user if it is determined that the first stimulus induced a response of the muscle within the response window;
wherein the response window corresponds to a period of time when an induced response to the first stimulus is likely to occur; and
wherein the response window extends between a third time (T3) and a fourth time (T4) such that T1≤T3<T4<T2.

### Claim 2 (depends on 1)

The neural monitoring system of claim 1, wherein the processor is further configured to determine if the first stimulus induced a response of the muscle by analyzing the mechanomyography output signal only within the response window.

### Claim 3 (depends on 1)

The neural monitoring system of claim 1, wherein the processor is configured to determine if the first stimulus induced a response of the muscle by examining one or more characteristics of the mechanomyography output signal within the response window using a supervised learning algorithm; and
wherein the supervised learning algorithm is operative to classify the response window into one of a plurality of classifications, the plurality of classifications comprising:
a first classification wherein the mechanomyography output signal within the response window is indicative of an artificially-induced mechanical response of the muscle; and
a second classification wherein the mechanomyography output signal within the response window is not indicative of an artificially-induced mechanical response of the muscle.

### Claim 4 (depends on 3)

The neural monitoring system of claim 3, wherein the one or more characteristics of the mechanomyography output signal includes a graph of an amplitude of the mechanomyography output signal throughout the response window as a function of time; and
wherein the supervised learning algorithm includes an image-based classifier operative to analyze one or more graphical aspects of the graph.

### Claim 5 (depends on 1)

The neural monitoring system of claim 1, wherein the mechanical sensor is a tri-axis accelerometer operative to monitor acceleration in three mutually orthogonal axes; and
wherein the processor is configured to determine if the first stimulus induced a response of the muscle using a magnitude of a resultant vector calculated from the monitored acceleration in each of the three axes.

### Claim 6 (depends on 5)

The neural monitoring system of claim 5, wherein the processor is configured to determine if the first stimulus induced a response of the muscle only if a magnitude of a movement of the muscle in a direction normal to a skin surface is greater than a magnitude of a movement of the muscle in a direction that is tangential to the skin surface.

### Claim 7 (depends on 1)

The neural monitoring system of claim 1, wherein (T4−T3)≤(T2−T1)/2.

### Claim 8 (depends on 1)

The neural monitoring system of claim 1, wherein the processor is further configured to:
identify signal content from the mechanomyography output signal that exists at least partially outside of the response window;
determine a frequency component of the signal content;
attenuate the frequency component from the mechanomyography output signal within the response window; and
wherein the processor is configured to determine if the first stimulus induced a response of the muscle using the attenuated mechanomyography output signal within the response window.

### Claim 9 (depends on 8)

The neural monitoring system of claim 8, wherein the signal content from the mechanomyography output signal exists at least partially between T1 and T2.

### Claim 10 (depends on 8)

The neural monitoring system of claim 8, wherein the periodic stimulus includes a plurality of stimuli; and
wherein the signal content exists across the plurality of stimuli.

### Claim 11 (depends on 1)

The neural monitoring system of claim 1, wherein the processor is further configured to
identify a time corresponding to a detected induced muscle response within the response window;
determine a first response latency between the first stimulus and the time corresponding to a detected induced muscle response;
identify a time corresponding to a subsequently detected muscle response that is induced by a subsequent stimulus provided by the stimulator;
determine a second response latency between the subsequent stimulus and the time of the subsequently detected muscle response; and
provide an alert if the second response latency differs from the first response latency by more than a predetermined amount.

### Claim 12 (depends on 1)

The neural monitoring system of claim 1, wherein the first stimulus has a first current magnitude, a subsequent stimulus has a second current magnitude, and a detected induced muscle response to the first stimulus has a mechanomyography output signal magnitude; and
wherein the second current magnitude is:
different from the first current magnitude; and
is a function of a difference between the mechanomyography output signal magnitude and a threshold output signal magnitude.

### Claim 13 (depends on 12)

The neural monitoring system of claim 12, wherein the second current magnitude is proportional to the difference between the mechanomyography output signal magnitude and a threshold output signal magnitude.

### Claim 14

A method of detecting an artificially-induced mechanical response of a muscle to a stimulus provided within an intracorporeal treatment area of a human subject, the intracorporeal treatment area including a nerve that innervates the muscle, the method comprising:
transmitting a periodic electrical stimulus to a stimulator within the intracorporeal treatment area, the periodic stimulus including at least a first stimulus beginning at a first time (T1), and a second, consecutive stimulus beginning at a second time (T2);
receiving a mechanomyography output signal from a non-invasive mechanical sensor in mechanical communication with the muscle, wherein the mechanomyography output signal corresponds to a sensed mechanical movement of the muscle;
analyzing the mechanomyography output signal within a response window of time to determine if the sensed motion is representative of an artificially-induced response of the muscle, wherein the response window corresponds to a period when an induced response of the muscle to the first stimulus is likely to occur, the response window extending between a third time (T3) and a fourth time (T4) such that T1≤T3<T4<T2; and
providing an indication to a user that the sensed motion is an artificially-induced muscle response only if the motion occurs within the response window.

### Claim 15 (depends on 14)

The method of claim 14, further comprising: analyzing the mechanomyography output signal only within the response window to determine if the sensed motion is an artificially-induced muscle response.

### Claim 16 (depends on 14)

The method of claim 14, further comprising: examining one or more characteristics of the mechanomyography output signal within the response window using a supervised learning algorithm to determine if the sensed mechanical movement of the muscle is an artificially-induced muscle response; and
wherein the supervised learning algorithm is operative to classify the mechanomyography output signal within the response window into one of a plurality of classifications, the plurality of classifications comprising:
a first classification wherein the mechanomyography output signal within the response window is indicative of an artificially-induced mechanical response of the muscle; and
a second classification wherein the mechanomyography output signal within the response window is not indicative of an artificially-induced mechanical response of the muscle.

### Claim 17 (depends on 14)

The method of claim 14, wherein (T4−T3)≤(T2−T1)/2.

### Claim 18 (depends on 14)

The method of claim 14, further comprising:
identifying signal content from the mechanomyography output signal that exists at least partially outside of the response window;
determining a frequency component of the signal content;
attenuating the frequency component from the mechanomyography output signal within the response window; and
determining an occurrence of a muscle event using the attenuated mechanomyography output signal within the response window.

### Claim 19 (depends on 14)

The method of claim 14, further comprising:
identifying a time of the muscle response within the response window;
determining a first response latency between T1 and the time of the muscle response;
identifying a time of a second muscle response within a second response window following a third stimulus provided by the stimulator beginning at a third time (T3);
determining a second response latency between T3 and the time of the second muscle response; and
providing an alert if the second response latency differs from the first response latency by more than a predetermined amount.

### Claim 20 (depends on 14)

The method of claim 14, wherein the first stimulus has a first current magnitude, the second stimulus has a second current magnitude, and the muscle response has a mechanomyography output signal magnitude; and
wherein transmitting the periodic electrical stimulus includes transmitting the second current magnitude such that the second current magnitude is:
different from the first current magnitude; and
is a function of a difference between the mechanomyography output signal magnitude and a threshold output signal magnitude.