# US 10,368,793 B2 · Wireless nerve integrity monitoring systems and devices

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- Number: US 10,368,793 B2
- Document ID: US10368793B2
- Status: Granted
- Kind: B2
- Application number: 15/883,395
- Filed: 2018-01-30
- Published: 2018-06-14
- Granted: 2019-08-06
- Earliest claimed: 2014-08-08
- Assignees: Medtronic Xomed, Inc.
- Applicants: Medtronic Xomed, Inc.
- Inventors: Richard L. Brown; John G. Pollock; Kevin L. McFarlin; Randal C. Schulhauser
- Web page: https://patentgrep.com/patent/US10368793B2

## CPC

- A61B 5/4041: {Evaluating nerves condition}
- A61B 1/00004: {characterised by electronic signal processing}
- A61B 1/00016: {using wireless means}
- A61B 1/00036: {Means for power saving, e.g. sleeping mode}
- A61B 1/2673: {for monitoring movements of vocal chords}
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/0004: {characterised by the type of physiological signal transmitted}
- A61B 5/0008: {Temperature signals}
- A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61B 5/14539: {for measuring pH}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/296: for electromyography [EMG]
- A61B 5/389: Electromyography [EMG]
- A61B 5/397: Analysis of electromyograms
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/6833: {Adhesive patches}
- A61B 5/6843: {Monitoring or controlling sensor contact pressure}
- A61B 5/6848: {Needles}
- A61B 5/6852: {Catheters}
- A61B 5/7475: {User input or interface means, e.g. keyboard, pointing device, joystick}
- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- A61M 16/0443: {Special cuff-wall materials (A61M16/0481, A61M16/0422 take precedence)}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36034: {specified by the stimulation parameters}
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/1107: {Measuring contraction of parts of the body, e.g. organ or muscle}
- A61B 2560/0209: adapted for power saving
- A61B 2562/0209: Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/36: related to heating or cooling
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/8206: battery-operated
- A61M 2230/06: Heartbeat rate only
- A61M 2230/42: Rate
- A61M 2230/50: Temperature
- A61M 2230/60: Muscle strain, i.e. measured on the user
- A61M 2230/63: Motion, e.g. physical activity
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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 nerve integrity monitoring device includes a control module and a physical layer module. The control module is configured to generate a payload request. The payload request (i) requests a data payload from a sensor in a wireless nerve integrity monitoring network, and (ii) indicates whether a stimulation probe device is to generate a stimulation pulse. The physical layer module is configured to (i) wirelessly transmit the payload request to the sensor and the stimulation probe device, or (ii) transmit the payload request to a console interface module. The physical layer module is also configured to, in response to the payload request, (i) receive the data payload from the sensor, and (ii) receive stimulation pulse information from the stimulation probe device. The data payload includes data corresponding to an evoked response of a patient. The evoked response is generated based on the stimulation pulse.

## Claims

### Claim 1

A nerve integrity monitoring system comprising:
a console interface module;
nerve integrity monitoring device comprising:
a first control module configured to generate a payload request, wherein the payload request (i) requests a data payload from a sensor in a wireless nerve integrity monitoring network, and (ii) indicates whether a stimulation probe device is to generate a stimulation pulse; and
a first physical layer module configured to
(i) wirelessly transmit the payload request to the sensor and the stimulation probe device, or (ii) transmit the payload request to the console interface module, and
in response to the payload request, (i) receive the data payload from the sensor or the console interface module, and (ii) receive stimulation pulse information from the stimulation probe device or the console interface module, wherein the data payload includes data corresponding to an evoked response of a patient, and wherein the evoked response is generated based on the stimulation pulse;
wherein the console interface module comprises:
a second control module configured to generate a synchronization request including information in the payload request, wherein the synchronization request (i) requests the data payload from the sensor, and (ii) indicates whether the stimulation probe device is to generate the stimulation pulse; and
a second physical layer module configured to
wirelessly transmit the synchronization request to the sensor and the stimulation probe device, and
in response to the synchronization request, (i) wirelessly receive the data payload from the sensor, and (ii) wirelessly receive the stimulation pulse information from the stimulation probe device.

### Claim 2 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the first physical layer module is connected to the console interface module or is separate from and remotely located away from the console interface module.

### Claim 3 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the stimulation pulse information comprises an amplitude of the stimulation pulse and a duration of the stimulation pulse.

### Claim 4 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the payload request comprises a data rate at which the sensor is to communicate the data payload to the first physical layer module or the console interface module.

### Claim 5 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the payload request comprises a second data rate at which the stimulation probe device is to communicate the stimulation pulse information to the first physical module or the console interface module.

### Claim 6 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein:
the payload request comprises slot status words; and
each of the slot status words indicates whether a time slot is allocated to the sensor or another sensor.

### Claim 7 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the payload request comprises request sequencer bits indicating which of a series of synchronization intervals the sensor is to transmit data to the first physical module or the console interface module.

### Claim 8 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the payload request comprises a unique identifier of the sensor or indicates a type of the sensor.

### Claim 9 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the payload request indicates whether each of a plurality of time slots, in each of a plurality of synchronization intervals is: available; in a process of being assigned; or designated to the sensor or to another sensor.

### Claim 10 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the first physical layer module is configured to (i) receive a radio frequency signal from a sensing module of the sensor, and (ii) down convert the radio frequency signal to a base band signal.

### Claim 11 (depends on 10)

The nerve integrity monitoring system of claim 10, wherein the nerve integrity monitoring device is configured to display versions of the base band signal.

### Claim 12 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the first physical layer module is configured to:
wirelessly transmit the payload request to the sensor and the stimulation probe device; and
in response to the payload request, (i) receive the data payload from the sensor, and (ii) receive the stimulation pulse information from the stimulation probe device.

### Claim 13 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the first physical layer module is configured to:
wirelessly transmit the payload request to the console interface module; and
in response to the payload request, (i) receive the data payload, generated at the sensor, from the console interface module, and (ii) receive the stimulation pulse information, generated at the stimulation probe device, from the console interface module.

### Claim 14 (depends on 1)

The nerve integrity monitoring system of claim 1, further comprising:
the stimulation probe device, wherein the stimulation probe device is in wireless communication with the console interface module or the nerve integrity monitoring device, and wherein the stimulation probe device is configured to (i) wirelessly receive the payload request, (ii) in response to the payload request, generate a stimulation pulse, and (iii) wirelessly transmit information pertaining to the stimulation pulse to the console interface module or the nerve integrity monitoring device.

### Claim 15 (depends on 1)

The nerve integrity monitoring system of claim 1, wherein the
second control module is further configured to receive the payload request from the nerve integrity monitoring device.

### Claim 16 (depends on 15)

The nerve integrity monitoring system of claim 15, wherein the second physical layer module is configured to transmit the data payload and the stimulation pulse information to the nerve integrity monitoring device.

### Claim 17 (depends on 15)

The nerve integrity monitoring system of claim 15, wherein the second physical layer module is connected to the nerve integrity monitoring device or is separate from and remotely located away from the nerve integrity monitoring device.

### Claim 18 (depends on 15)

The nerve integrity monitoring system of claim 15, wherein the stimulation pulse information comprises an amplitude of the stimulation pulse and a duration of the stimulation pulse.

### Claim 19 (depends on 15)

The nerve integrity monitoring system of claim 15, wherein:
the synchronization request comprises slot status words; and
each of the slot status words indicates whether a time slot is allocated to the sensor or another sensor.

### Claim 20 (depends on 15)

The nerve integrity monitoring system of claim 15, wherein the synchronization request comprises request sequencer bits indicating which of a series of synchronization intervals the sensor is to transmit data to the second physical layer module.

### Claim 21 (depends on 15)

The nerve integrity monitoring system of claim 15, wherein the synchronization request comprises a unique identifier of the sensor or indicates a type of the sensor.

### Claim 22 (depends on 15)

The nerve integrity monitoring system of claim 15, wherein the synchronization request indicates whether each of a plurality of time slots, in each of a plurality of synchronization intervals is: available; in a process of being assigned; or designated to the sensor or to another sensor.

### Claim 23

A nerve integrity monitoring system comprising:
a nerve integrity monitoring device comprising:
a first control module configured to generate a payload request, wherein the payload request (i) requests a data payload from a sensor in a wireless nerve integrity monitoring network, and (ii) indicates whether a stimulation probe device is to generate a stimulation pulse, and
a first physical layer module configured to
(i) wirelessly transmit the payload request to the sensor and the stimulation probe device, or (ii) transmit the payload request to the console interface module, and
in response to the payload request, (i) receive the data payload from the sensor or the console interface module, and (ii) receive stimulation pulse information from the stimulation probe device or the console interface module, wherein the data payload includes data corresponding to an evoked response of a patient, and wherein the evoked response is generated based on the stimulation pulse; and
the sensor comprising a first sensing module, wherein the first sensing module is configured to receive (i) a payload request signal, and (ii) a first electromyographic signal from the patient via a first set of electrodes, and wherein the first sensing module comprises:
a processing module configured to amplify and filter the first electromyographic signal to generate a first voltage signal, and
a second physical layer module configured to (i) upconvert the first voltage signal to a first radio frequency signal, and (ii) wirelessly transmit the first radio frequency signal based on the payload request signal,
wherein the first physical layer module is configured to (i) transmit the payload request signal to the first sensing module, (ii) receive the first radio frequency signal from the second physical layer module, and (iii) downconvert the first radio frequency signal to a baseband signal.

### Claim 24 (depends on 23)

The nerve integrity monitoring system of claim 23, further comprising an endotracheal tube assembly, wherein the endotracheal tube assembly comprises:
an endotracheal tube for insertion in an airway of the patient, wherein the endotracheal tube comprises a proximal end, a distal end, a contact, and a trace, wherein the contact is on the endotracheal tube and is closer to the proximal end than the distal end, and wherein the trace extends between the contact and the distal end and is configured to receive a second electromyographic signal from the patient via the contact; and
a second sensing module configured to connect to the trace and receive the second electromyographic signal, wherein the second sensing module is configured to (i) detect the second electromyographic signal and generate a second voltage signal, (ii) upconvert the second voltage signal to a second radio frequency signal, and (iii) wirelessly transmit the second radio frequency signal from the second sensing module to the console interface module or the nerve integrity monitoring device.

### Claim 25 (depends on 23)

The nerve integrity monitoring system of claim 23, further comprising a plurality of sensors, wherein:
the plurality of sensors comprise the first sensor and are attached to the patient;
the plurality of sensors are configured to generate a plurality of radio frequency signals;
the plurality of radio frequency signals comprise the first radio frequency signal; and
the first physical layer module is configured to (i) receive the plurality of radio frequency signals from the second physical layer module, and (ii) downconvert the plurality of radio frequency signals to baseband signals.

### Claim 26 (depends on 25)

The nerve integrity monitoring system of claim 25, wherein the nerve integrity monitoring device is configured to display versions of the baseband signals.

### Claim 27 (depends on 25)

The nerve integrity monitoring system of claim 25, further comprising a plurality of sensing modules, wherein:
the plurality of sensing modules comprise the first sensing module and a second sensing module;
the first set of electrodes include pin electrodes;
the second sensing module is configured to (i) receive a second electromyographic signal via a second set of electrodes, and (ii) generate a second radio frequency signal;
the plurality of radio frequency signals comprises the second radio frequency signal; and
the second set of electrodes include pad electrodes.