# US 11,298,535 B2 · Non-invasive vagus nerve stimulation

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- Number: US 11,298,535 B2
- Document ID: US11298535B2
- Status: Granted
- Kind: B2
- Application number: 17/220,805
- Filed: 2021-04-01
- Published: 2021-07-22
- Granted: 2022-04-12
- Earliest claimed: 2009-03-20
- Assignees: ElectroCore, Inc.
- Applicants: ElectroCore, Inc.
- Inventors: Bruce J. Simon; Joseph P. Errico; John T. Raffle
- Web page: https://patentgrep.com/patent/US11298535B2

## CPC

- A61N 1/36021: {for treatment of pain}
- A61N 1/36034: {specified by the stimulation parameters}
- G06Q 10/10: Office automation; Time management
- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 2560/0456: Apparatus provided with a docking unit
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/37235: {Aspects of the external programmer}
- A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61N 2/008: {for pain treatment or analgesia}
- A61N 2/02: using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence)
- 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)
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices, systems and methods are disclosed that allow a patient to self-treat a medical condition, such as migraine headache, by electrical noninvasive stimulation of a vagus nerve. The system comprises a stimulator that applies an electrical impulse transcutaneously through an outer skin surface of the patient. The electrical impulse includes pulses having a frequency of about 1 kHz to about 20 kHz. The device housing may transmit data to or from a patient interface device, such as a mobile phone or computer, relating to the stimulation parameters. The interface device in turn may communicate with a database contained within other computers, via a network or the internet.

## Claims

### Claim 1

A method for treating a medical condition in a patient, the method comprising:
positioning a device adjacent to, or in contact with, an outer skin surface of the patient, wherein the outer skin surface is adjacent to an auricular branch of the vagus nerve;
generating an electrical impulse sufficient to modulate a vagus nerve within the patient;
transmitting the electrical impulse transcutaneously through the outer skin surface to the vagus nerve such that the vagus nerve is modulated and thereby the medical condition is treated, wherein the electrical impulse comprises pulses having a frequency of about 2.5 kHz to about 7.5 kHz.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pulses have a frequency of about 5 kHz.

### Claim 3 (depends on 1)

The method of claim 1, further comprising transmitting an electric current from the device through the outer skin surface to the vagus nerve.

### Claim 4 (depends on 1)

The method of claim 1, wherein the electrical impulse is an electric field.

### Claim 5 (depends on 1)

The method of claim 1, wherein the pulses have a pulse width of about 1 microsecond to about 1,000 microseconds.

### Claim 6 (depends on 4)

The method of claim 4 further comprising varying the electric field to create burst periods and constant periods, wherein the charge of the electric field emitted during the burst periods alternates between positive and negative, wherein the frequency of the burst periods is about 1 to about 100 Hz.

### Claim 7 (depends on 1)

The method of claim 1 further comprising positioning one or more electrodes near the outer skin surface and applying a voltage to the electrode(s) to generate the electric field.

### Claim 8 (depends on 6)

The method of claim 6, wherein the charge of the electric field alternates between positive and negative 2 and 20 times per burst.

### Claim 9 (depends on 1)

The method of claim 1, further comprising communicating data for one or more stimulation parameters wirelessly to the device.

### Claim 10 (depends on 9)

The method of claim 9, further comprising communicating data from a remote source to a mobile device and wirelessly coupling the mobile device to the device in order to transmit the data to the device.

### Claim 11 (depends on 10)

The method of claim 10, further comprising communicating authorization to the device in order to enable the device to operate.

### Claim 12

A device for treating a medical condition in a patient, the device comprising:
a housing having a contact surface for contacting an outer skin surface of a patient adjacent to an auricular branch of the vagus nerve; and
an energy source coupled to the housing, the energy source being configured to generate an electrical impulse sufficient to modulate a vagus nerve within the patient and to transmit the electrical impulse transcutaneously through the outer skin surface to the vagus nerve such that the vagus nerve is modulated and thereby the medical condition is treated, wherein the electrical impulse comprises pulses having a frequency of about 2.5 kHz to about 7.5 kHz.

### Claim 13 (depends on 12)

The device of claim 12 further comprising one or more electrodes coupled to the energy source, wherein the energy source applies a voltage to the electrode(s) to generate the electrical impulse.

### Claim 14 (depends on 12)

The device of claim 12, wherein the energy source transmits an electric current through the outer skin surface to the vagus nerve.

### Claim 15 (depends on 12)

The device of claim 12, wherein the pulses have a frequency of about 5 kHz.

### Claim 16 (depends on 12)

The device of claim 12, wherein the electrical impulse is an electric field.

### Claim 17 (depends on 12)

The device of claim 12, wherein the pulses have a pulse width of about 1 microsecond to about 1,000 microseconds.

### Claim 18 (depends on 16)

The device of claim 16, wherein the energy source is configured to vary the electric field to create burst periods and constant periods, wherein the charge of the electric field emitted during the burst periods alternates between positive and negative, wherein the frequency of the burst periods is about 1 to about 100 Hz.

### Claim 19 (depends on 18)

The device of claim 18, wherein the charge of the electric field alternates between positive and negative 2 and 20 times per burst.

### Claim 20 (depends on 12)

The device of claim 12, wherein the energy source is housed within the housing.

### Claim 21 (depends on 12)

The device of claim 12, further comprising a mobile device that receives data from a remote source, wherein the mobile device couples to the housing and transmits the data to the housing, wherein the data includes one or more stimulation parameters for treating a medical condition in the patient.

### Claim 22 (depends on 21)

The device of claim 21, wherein the one or more stimulation parameters includes an amplitude of the electrical impulse.

### Claim 23 (depends on 12)

The device of claim 12, wherein the energy source includes a signal generator within the housing.