# US 10,478,623 B2 · System and method for non-invasively controlling autonomic nerve activity

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- Number: US 10,478,623 B2
- Document ID: US10478623B2
- Status: Granted
- Kind: B2
- Application number: 15/519,918
- Filed: 2015-10-20
- Published: 2017-11-23
- Granted: 2019-11-19
- Earliest claimed: 2014-10-20
- Assignees: Indiana University Research and Technology Corporation
- Applicants: Indiana University Research & Technology Corporation
- Inventors: Peng-Sheng Chen
- Web page: https://patentgrep.com/patent/US10478623B2

## CPC

- A61N 1/36034: {specified by the stimulation parameters}
- A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24)
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 5/4029: {for evaluating the peripheral nervous systems (using bioelectric or biomagnetic signals A61B5/24)}
- A61B 5/6877: {Nerve}
- A61B 5/725: {using specific filters therefor, e.g. Kalman or adaptive filters (specific diagnostics methods using using bioelectric or biomagnetic signals A61B5/316)}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/0504: {Subcutaneous electrodes}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy}
- A61N 1/36592: {controlled by the heart rate variability}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

System and methods for monitoring and/or controlling nerve activity in a subject are provided. In one embodiment, a system includes electrodes configured to be placed proximate to a subject's skin, and a signal detector configured to detect electrical signals using the electrodes. The system also includes a signal processor configured to receive the electrical signals from the signal detector, and apply a filter to the received electrical signals to generate filtered signals, the filter configured to attenuate at least signals having frequencies corresponding to heart muscle activity during a heartbeat. The signal processor is also configured to identify a skin nerve activity using the filtered signals, estimate a sympathetic nerve activity using the identified skin nerve activity, and further to generate a report indicative of the estimated sympathetic nerve activity. In some aspects, the system further includes a signal generator to deliver the electrical stimulation to the subject's skin.

## Claims

### Claim 1

A method for controlling nerve activity in a subject, the method comprising:
placing a plurality of electrodes at locations proximate to nerves innervating a subject's skin;
generating an electrical stimulation configured to remodel at least one neural structure; and
delivering the electrical stimulation to the neural structure via the nerves innervating the subject's skin using the plurality of electrodes to control a sympathetic nerve activity.

### Claim 2 (depends on 1)

The method of claim 1, wherein the nerves comprise cutaneous nerves or subcutaneous nerves, or both.

### Claim 3 (depends on 1)

The method of claim 1, wherein the at least one neural structure comprises a stellate ganglion.

### Claim 4 (depends on 1)

The method of claim 1, wherein electrical stimulation comprises intermittent periods of stimulation pulses separated by time intervals approximately between 1 minute and 3 minutes, the intermittent periods of stimulation pulses having a duration approximately 14 seconds, a stimulation frequency of approximately 10 Hz, a pulse width of approximately 0.5 milliseconds and an intensity amplitude in the range of 1.0 milliAmperes to 3.5 milliAmperes.

### Claim 5 (depends on 1)

The method of claim 1, wherein the sympathetic nerve activity comprises a stellate ganglion nerve activity.

### Claim 6 (depends on 1)

The method of claim 1, wherein the method further comprises estimating a sympathetic nerve activity using a skin nerve activity.

### Claim 7 (depends on 6)

The method of claim 6, wherein the method further comprises identifying the skin nerve activity by processing electrical signals acquired from locations proximate to the subject's skin.

### Claim 8

A method for controlling nerve activity in a subject, the method comprising:
sampling electrical signals from locations proximate to a subject's skin using a plurality of electrodes placed thereabout;
amplifying the electrical signals to generate a plurality of amplified signals;
applying a filter to the amplified signals to generate a plurality of filtered signals, the filter configured to attenuate at least signals having frequencies that correspond to heart muscle activity during a heartbeat;
identifying a skin nerve activity using the plurality of filtered signals;
estimating a sympathetic nerve activity using the identified skin nerve activity;
generating, based upon the estimated sympathetic nerve activity, an electrical stimulation configured to remodel at least one neural structure; and
delivering the electrical stimulation to the neural structure via the nerves innervating the subject's skin using the plurality of electrodes to control a sympathetic nerve activity.

### Claim 9 (depends on 8)

The method of claim 8, wherein the locations are associated with cutaneous nerves or subcutaneous nerves, or both.

### Claim 10 (depends on 8)

The method of claim 8, wherein the at least one neural structure comprises a stellate ganglion.

### Claim 11 (depends on 8)

The method of claim 8, wherein the sympathetic nerve activity comprises a stellate ganglion nerve activity.

### Claim 12 (depends on 8)

The method of claim 8, wherein electrical stimulation includes comprises intermittent periods of stimulation pulses separated by time intervals approximately between 1 minute and 3 minutes, the intermittent periods of stimulation pulses having a duration approximately 14 seconds, a stimulation frequency of approximately 10 Hz, a pulse width of approximately 0.5 milliseconds and an intensity amplitude in the range of 1.0 milliAmperes to 3.5 milliAmperes.

### Claim 13

A system for controlling nerve activity in a subject, the system comprising:
a plurality of electrodes configured for placement at locations proximate to nerves innervating a subject's skin;
a signal generator configured to generate electrical stimulations; and
a processor configured to direct the signal generator to deliver, using the plurality of electrodes, an electrical stimulation configured to control a sympathetic nerve activity by remodeling at least one neural structure in the subject, the electrical stimulation delivered to the neural structure via the nerves innervating the subject's skin.

### Claim 14 (depends on 13)

The system of claim 13, wherein the plurality of electrodes are configured to engage tissues in the subject comprising cutaneous nerves or subcutaneous nerves, or both.

### Claim 15 (depends on 13)

The system of claim 13, wherein the at least one neural structure comprises a stellate ganglion.

### Claim 16 (depends on 13)

The system of claim 13, wherein the processor is further configured to direct the signal generator to deliver the electrical stimulation with intermittent periods of stimulation pulses separated by time intervals approximately between 1 minute and 3 minutes, the intermittent periods of stimulation pulses having a duration approximately 14 seconds, a stimulation frequency of approximately 10 Hz, a pulse width of approximately 0.5 milliseconds and an intensity amplitude in the range of 1.0 milliAmperes to 3.5 milliAmperes.

### Claim 17 (depends on 13)

The system of claim 13, wherein the sympathetic nerve activity comprises a stellate ganglion nerve activity.

### Claim 18 (depends on 13)

The system of claim 13, wherein the processor is further configured to determine the electrical stimulation based on an estimated skin nerve activity.
