# US 12,594,418 B2 · Devices and methods for nerve stimulation

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- Number: US 12,594,418 B2
- Document ID: US12594418B2
- Status: Granted
- Kind: B2
- Application number: 19/266,246
- Filed: 2025-07-11
- Published: 2025-11-06
- Granted: 2026-04-07
- Earliest claimed: 2011-03-10
- Assignees: ElectroCore, Inc.
- Applicants: ElectroCore, Inc.
- Inventors: Bruce J. Simon; Joseph P. Errico; John T. Raffle
- Web page: https://patentgrep.com/patent/US12594418B2

## 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 signal to the electrode such that the electrical signal passes through the outer skin surface of the user to a nerve at a target region in the patient sufficient to modulate the nerve. The electrical impulse comprises burst periods and constant periods and each burst period includes a plurality of pulses. The pulses have a frequency of about 1 kHz to about 20 kHz and alternate between a positive voltage and a negative voltage within each burst period.

## Claims

### Claim 1

A method comprising:
positioning a device adjacent an outer skin surface of a user;
generating an electrical signal; and
transmitting the electrical signal from the device through the outer skin surface to a target nerve within the user, wherein the electrical signal comprises burst periods and constant periods, wherein each burst period includes a plurality of pulses, wherein the pulses have a frequency of about 1 kHz to about 20 kHz and alternate between a positive voltage and a negative voltage within each burst period.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

The method of claim 1, wherein each burst period comprises 2 to 20 pulses.

### Claim 4 (depends on 1)

The method of claim 1, wherein a voltage generated during the constant periods has a magnitude of about zero.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

The method of claim 1, wherein a duration of the burst periods is less than about 20,000 microseconds.

### Claim 8 (depends on 7)

The method of claim 7, wherein the duration of the burst periods is less than about 2,000 microseconds.

### Claim 9 (depends on 7)

The method of claim 7, wherein the duration of the bursts periods if about 1,000 or less.

### Claim 10 (depends on 1)

The method of claim 1, wherein a duration of the pulses is about 50 microseconds to about 1,000 microseconds.

### Claim 11

A device comprising:
a housing having a contact surface for contacting an outer skin surface of a user; and
an energy source coupled to the housing, the energy source being configured to generate an electrical signal within the housing and transmit the electrical impulse through the outer skin surface to a target nerve within the user, wherein the electrical signal comprises burst periods and constant periods, wherein each burst period includes a plurality of pulses, wherein the pulses have a frequency of about 1 kHz to about 20 kHz and alternate between a positive voltage and a negative voltage within each burst period.

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 11)

The device of claim 11, wherein each burst period comprises 2 to 20 pulses.

### Claim 14 (depends on 11)

The device of claim 11, wherein a voltage generated during the constant periods has a magnitude of about zero.

### Claim 15 (depends on 11)

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

### Claim 16 (depends on 11)

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

### Claim 17 (depends on 11)

The device of claim 11, wherein a duration of the burst periods is less than about 20,000 microseconds.

### Claim 18 (depends on 17)

The device of claim 17, wherein the duration of the burst periods is less than about 2,000 microseconds.

### Claim 19 (depends on 11)

The device of claim 11, wherein a duration of the pulses is about 50 microseconds to about 1,000 microseconds.

### Claim 20 (depends on 11)

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