# US 12,179,012 B2 · Devices and methods for non-invasive nerve stimulation

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- Number: US 12,179,012 B2
- Document ID: US12179012B2
- Status: Granted
- Kind: B2
- Application number: 17/713,832
- Filed: 2022-04-05
- Published: 2022-07-28
- Granted: 2024-12-31
- Earliest claimed: 2010-08-19
- Assignees: ElectroCore, Inc.
- Applicants: electroCore, Inc.
- Inventors: Bruce J. Simon; Joseph P. Errico; John T. Raffle
- Web page: https://patentgrep.com/patent/US12179012B2

## CPC

- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0472: {Structure-related aspects}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals}
- 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

Devices and methods for the non-invasive stimulation of nerves, such as the vagus nerve, include a housing and an electrode coupled to the housing. The electrode is configured to be positioned adjacent to, or in contact with, an outer skin surface of a patient. A source of energy is coupled to the housing and operably coupled to the electrode. The source of energy emits an electrical impulse to the electrode such that the electrical impulse passes through the outer skin surface of the patient to a nerve at a target region in the patient sufficient to modulate the nerve. The electrical impulse comprises burst periods and constant periods, wherein each burst period includes 2 to 20 pulses and has a duration of less than 20,000 microseconds.

## Claims

### Claim 1

A method for treating a disorder in a patient, the method comprising:
positioning a device adjacent an outer skin surface of the patient;
generating an electrical impulse within the device; and
transmitting the electrical impulse from the device through the outer skin surface to a target nerve within the patient, wherein the electrical impulse comprises burst periods and constant periods, wherein each burst period includes 4 to 10 pulses and has a duration between 800 microseconds and 2,000 microseconds, wherein the pulses alternate between a positive voltage and a negative voltage within each burst period.

### Claim 2 (depends on 1)

The method of claim 1 further comprising positioning an electrode near the outer skin surface and applying a voltage to the electrode to generate an electric field.

### Claim 3 (depends on 2)

The method of claim 2 further comprising varying the voltage such that the electric field emitted by the electrode includes the burst periods and the constant periods.

### Claim 4 (depends on 2)

The method of claim 2, wherein the electric field generated during the constant periods has a magnitude of about zero.

### Claim 5 (depends on 1)

The method of claim 1, wherein the burst periods have a frequency of about 1 Hz to about 100 Hz.

### Claim 6 (depends on 1)

The method of claim 1, wherein the constant periods have a longer duration than the burst periods.

### Claim 7 (depends on 1)

The method of claim 1, further comprising transmitting the electrical impulse from the device through the outer skin surface to the target nerve.

### Claim 8 (depends on 1)

The method of claim 1, wherein the target nerve is a vagus nerve.

### Claim 9 (depends on 1)

The method of claim 1, wherein the duration of the pulses is about 200 microseconds.

### Claim 10 (depends on 1)

The method of claim 1, wherein the disorder is a headache.

### Claim 11

A device for treating a disorder in a patient, the device comprising:
a housing having a contact surface for contacting an outer skin surface of a patient; and
an energy source coupled to the housing, the energy source being configured to generate an electrical impulse within the housing and transmit the electrical impulse through the outer skin surface to a target nerve within the patient, wherein the electrical impulse comprises burst periods and constant periods, wherein each burst period includes 4 to 10 pulses and has a duration of between 800 microseconds and 2,000 microseconds, wherein the pulses alternate between a positive voltage and a negative voltage within each burst period.

### Claim 12 (depends on 11)

The device of claim 11, further comprising an electrode coupled to the housing, wherein the energy source is configured to apply a voltage to the electrode to generate an electric field.

### Claim 13 (depends on 12)

The device of claim 12, wherein the energy source is configured to vary the voltage such that the electric field emitted by the electrode includes the burst periods and the constant periods.

### Claim 14 (depends on 12)

The device of claim 12, wherein the electric field generated during the constant periods has a magnitude of about zero.

### Claim 15 (depends on 11)

The device of claim 11, wherein the burst periods have a frequency of about 1 Hz to about 100 Hz.

### Claim 16 (depends on 11)

The device of claim 11, wherein the constant periods have a longer duration than the burst periods.

### Claim 17 (depends on 11)

The device of claim 11, wherein the energy source is configured to transmit the electrical impulse from the device through the outer skin surface to the target nerve.

### Claim 18 (depends on 11)

The device of claim 11, wherein the target nerve is a vagus nerve.

### Claim 19 (depends on 11)

The device of claim 11, wherein the duration of the pulses is about 200 microseconds.

### Claim 20 (depends on 11)

The device of claim 11, wherein the energy source is housed within the housing.

### Claim 21 (depends on 11)

The device of claim 11, wherein the disorder is a headache.
