# US 11,896,389 B2 · Paralysis monitoring system

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- Number: US 11,896,389 B2
- Document ID: US11896389B2
- Status: Granted
- Kind: B2
- Application number: 17/160,853
- Filed: 2021-01-28
- Published: 2021-05-20
- Granted: 2024-02-13
- Earliest claimed: 2017-03-10
- Applicants: Robert S. Bray, Jr.
- Inventors: Robert S. Bray, Jr.
- Web page: https://patentgrep.com/patent/US11896389B2

## CPC

- A61B 5/4821: {Determining level or depth of anaesthesia (based on movements A61B5/1106)}
- A61B 5/1106: {to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia}
- A61B 5/296: for electromyography [EMG]
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 5/4519: {Muscles (measuring muscular strength A61B5/224; using electromyography [EMG] A61B5/389)}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/6833: {Adhesive patches}
- A61B 5/6848: {Needles}
- A61B 5/6877: {Nerve}
- A61B 5/7214: {using signal cancellation, e.g. based on input of two identical physiological sensors spaced apart, or based on two signals derived from the same sensor, for different optical wavelengths}
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- 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 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61B 2505/05: Surgical care
- A61B 2560/0475: Special features of memory means, e.g. removable memory cards
- A61B 2562/043: in a linear array
- 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 paralysis monitoring system can be utilized during various medical procedures. Generally, the system is used during procedures involving anesthesia, when general paralysis is necessary, e.g., during surgery that requires cutting through or mobilizing muscle tissue. The paralysis monitoring system stimulates a nerve with low voltage signals and can provide for continuous monitoring and recording of the evoked muscle activity throughout and after a procedure. By monitoring a quantitative response of the muscle activity to nerve stimulation, an anesthesiologist may adjust subsequent doses of a paralytic agent to achieve a desired level of paralysis.

## Claims

### Claim 1

A paralysis monitoring system comprising:
a nerve stimulation device configured to deliver a series of low voltage electrical impulses to a nerve, wherein the low voltage electrical impulses are 4 millivolts or less;
wherein the nerve stimulation device is configured to transmit the low voltage electrical impulses to a patient based on a body mass index of the patient;
wherein the nerve stimulation device is configured to transmit the low voltage electrical impulses in the range of about 0.5 millivolts to 1.5 millivolts to patients having a body mass index in a first range;
wherein the nerve stimulation device is configured to transmit the low voltage electrical impulses in the range of about 1.5 millivolts to 4 millivolts to patients having a body mass index in a second range that is higher than the first range;
a first recording device configured to record electrical activity associated with an evoked muscle response to the nerve stimulation device;
a second recording device configured to record electrical activity associated with the series of low voltage electrical impulses to the nerve;
wherein the first recording device is configured to be placed over a target muscle group associated with the nerve; and
wherein the second recording device is configured to be disposed away from the target muscle group.

### Claim 2 (depends on 1)

The paralysis monitoring system according to claim 1, wherein the series of low voltage electrical impulses have magnitudes to produce only sub-visible muscle responses.

### Claim 3 (depends on 2)

The paralysis monitoring system according to claim 2, wherein the nerve stimulation device is configured to transmit low voltage signals in the range of about 0.1 millivolts to 4 millivolts.

### Claim 4 (depends on 1)

The paralysis monitoring system according to claim 1, wherein the nerve stimulation device, the first recording device, and the second recording device are disposed along a common axis.

### Claim 5 (depends on 1)

The paralysis monitoring system according to claim 1, wherein the nerve stimulation device and the first recording device are disposed along a first axis, wherein the nerve stimulation device and the second recording device are disposed along a second axis, and wherein the first axis and the second axis intersect at a nonzero angle.

### Claim 6 (depends on 5)

The paralysis monitoring system according to claim 5, wherein the non-zero angle is in a range between 30 degrees and 60 degrees.

### Claim 7 (depends on 1)

The paralysis monitoring system according to claim 1, wherein the first recording device is disposed substantially further from the nerve stimulation device than the second recording device.

### Claim 8 (depends on 7)

The paralysis monitoring system according to claim 7, wherein the first recording device is disposed a first recording distance from the nerve stimulation device;
wherein the second recording device is disposed a second recording distance from the nerve stimulation device; and
wherein the second recording distance is in a range between 30% and 70% of the first recording distance.

### Claim 9 (depends on 1)

The paralysis monitoring system according to claim 1, wherein the first recording device and the second recording device are equidistant from the nerve stimulation device.

### Claim 10 (depends on 1)

The paralysis monitoring system according to claim 1, wherein the nerve stimulation device and the first recording device are disposed on a first strip of material.

### Claim 11 (depends on 10)

The paralysis monitoring system according to claim 10, wherein the second recording device is disposed on a second strip of material that connects to the first strip of material.

### Claim 12 (depends on 1)

The paralysis monitoring system according to claim 1, wherein the first recording device is configured to record a first response signal;
wherein the second recording device is configured to record a second response signal; and
wherein information from the second response signal is used to interpret the first response signal.

### Claim 13 (depends on 1)

The paralysis monitoring system according to claim 1, further comprising an alarm configured to provide an alert upon detecting a return of response signals or muscle activity of a patient.

### Claim 14

A method of administering a paralysis agent to a patient, the method comprising:
attaching a nerve stimulation device to a patient's anatomy that includes a nerve;
attaching a first recording device to the patient's anatomy that includes a target muscle group associated with the nerve, wherein the first recording device is configured to record electrical activity associated with an evoked muscle response in the target muscle group to the nerve stimulation device;
attaching a second recording device to the patient's anatomy that is disposed away from the target muscle group, wherein the second recording device is configured to record electrical activity associated with electrical impulses to the nerve from the nerve stimulation device;
administering a first dose of a paralysis agent to the patient;
transmitting a series of low voltage electrical impulses from the nerve stimulation device to the patient, wherein the low voltage electrical impulses are 4 millivolts or less;
receiving, in response to the low voltage electrical impulses, a first response signal corresponding to the evoked muscle response in the target muscle group of the patient at the first recording device;
receiving, in response to the low voltage electrical impulses, a second response signal corresponding to the electrical activity in the patient's anatomy that is disposed away from the target muscle group at the second recording device;
using information related to the first response signal and the second response signal to determine an amount of the paralysis agent to administer as a second dose; and
administering the second dose of the paralysis agent to the patient.

### Claim 15 (depends on 14)

The method according to claim 14, wherein the low voltage electrical impulses have magnitudes to produce only sub-visible muscle responses.

### Claim 16 (depends on 14)

The method according to claim 14, wherein using information related to the first response signal and the second response signal includes comparing the first response signal to a baseline recording of the patient's muscle activity.

### Claim 17 (depends on 16)

The method according to claim 16, further comprising:
administering the second dose of the paralysis agent when the first response signal is equal to the baseline recording.

### Claim 18 (depends on 14)

The method according to claim 14, further comprising:
checking that electrical signals corresponding to the low voltage impulses are recorded at the second recording device.

### Claim 19 (depends on 18)

The method according to claim 18, further comprising:
using information from the second response signal recorded at the second recording device to interpret the first response signal received at the first recording device.

### Claim 20 (depends on 14)

The method according to claim 14, further comprising:
filtering the first response signal using the second response signal to generate a filtered signal, wherein the filtered signal is used to determine the amount of the paralysis agent to administer as the second dose.