# US 10,441,780 B2 · Systems and methods for vagal nerve stimulation

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- Number: US 10,441,780 B2
- Document ID: US10441780B2
- Status: Granted
- Kind: B2
- Application number: 13/952,916
- Filed: 2013-07-29
- Published: 2013-11-21
- Granted: 2019-10-15
- Earliest claimed: 2005-11-10
- Assignees: ElectroCore, Inc.
- Applicants: EIectroCore, LLC.
- Inventors: Bruce J. Simon; Joseph P. Errico
- Web page: https://patentgrep.com/patent/US10441780B2

## CPC

- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices, systems and methods are disclosed for electrical stimulation of the vagus nerve to treat or prevent disorders in a patient. The methods comprise transmitting impulses of energy to the vagus nerve according to a treatment paradigm that includes single doses of 30 seconds to 5 minutes of continuous stimulation. The treatment paradigm further comprises one or more daily treatment sessions that each include one or more doses for prophylactic or acute treatment of the patient's condition. Vagus nerve stimulation is used to modulate the release of inhibitory neurotransmitters in the brain, such as GABA, norepinephrine, and/or serotonin.

## Claims

### Claim 1

A method of treating or preventing a disorder in a patient, the method comprising:
positioning a contact surface of a device in contact with an outer skin surface of a neck of the patient, wherein the device comprises a housing and an energy source, wherein the energy source is located within the housing, wherein the contact surface is coupled to the energy source, and wherein the housing comprises an outer surface that includes the contact surface; and
applying, via the device, when the contact surface is in contact with the outer skin surface of the neck of the patient, one or more electrical impulses transcutaneously and non-invasively via the contact surface through the outer skin surface of the neck of the patient to a vagus nerve of the patient according to a treatment paradigm, wherein the energy source generates the one or more electrical impulses; and
wherein the treatment paradigm is based at least in part on an application of the electrical impulse as a single dose from two times to five times during the day.

### Claim 2 (depends on 1)

The method of claim 1, wherein the single dose is from about 60 seconds to about three minutes.

### Claim 3 (depends on 1)

The method of claim 1, wherein the single dose is from about 90 seconds to about 150 seconds.

### Claim 4 (depends on 1)

The method of claim 1, wherein the electrical impulse is not applied to the vagus nerve via the device between each single dose during the day.

### Claim 5 (depends on 1)

The method of claim 1, wherein the treatment paradigm comprises applying a treatment session during the day, wherein the treatment session comprises applying the single dose from 2 to 4 times within an hour time period.

### Claim 6 (depends on 5)

The method of claim 5, wherein the treatment session comprises applying the single dose twice within a 15 minute time period within the hour time period.

### Claim 7 (depends on 6)

The method of claim 6, wherein each single dose is applied within 5 minutes of each other during the day.

### Claim 8 (depends on 1)

The method of claim 1, wherein the applying comprises transmitting the electrical impulse from an electrode through a conducting medium positioned within the housing, wherein the housing comprises the electrode.

### Claim 9 (depends on 1)

The method of claim 1, wherein the electrical impulse has a frequency from about 1 KHz to about 20 KHz.

### Claim 10 (depends on 1)

The method of claim 1, wherein the electrical impulse has a frequency from about 2.5 KHz to about 10 KHz.

### Claim 11 (depends on 1)

The method of claim 1, wherein the electrical impulse has a frequency of about 5 KHz.

### Claim 12 (depends on 1)

The method of claim 1, wherein the electrical impulse comprises bursts of pulses with a frequency from about 1 burst per second to about 100 bursts per second.

### Claim 13 (depends on 12)

The method of claim 12, wherein each of the bursts contains from 1 pulse to 20 pulses.

### Claim 14 (depends on 12)

The method of claim 12, wherein the pulses are full sinusoidal waves.

### Claim 15 (depends on 12)

The method of claim 12, wherein each of the pulses is from about 100 microseconds to about 1000 microseconds in duration.

### Claim 16 (depends on 12)

The method of claim 12, wherein a duration of a pulse of the pulses within a burst of the bursts is about 200 microseconds, wherein a number of the pulses per burst of the bursts is from 4 to 6, and wherein a number of the bursts per second is from 20 to 30.

### Claim 17 (depends on 1)

The method of claim 1, wherein the electrical impulse generates an electric field at the vagus nerve above a threshold for generating an action potential within an A fiber or a B fiber of the vagus nerve and below a threshold for generating an action potential within a C fiber of the vagus nerve.

### Claim 18 (depends on 1)

The method of claim 1, wherein the electrical impulse generates an electric field at the vagus nerve above a threshold for generating an action potential within a fiber of the vagus nerve responsible for activating a neural pathway causing a release of an inhibitory neurotransmitter within a brain of the patient.

### Claim 19 (depends on 1)

The method of claim 1, wherein the energy source is a single energy source.

### Claim 20 (depends on 1)

The method of claim 1, wherein the contact surface is movable along the outer skin surface of the neck of the patient during the applying.

### Claim 21 (depends on 1)

The method of claim 1, wherein the contact surface is movable along the outer skin surface of the neck of the patient.

### Claim 22

A method of treating or preventing a disorder in a patient, the method comprising:
positioning a contact surface of a device in contact with an outer skin surface of a neck of the patient, wherein the device comprises a housing and an energy source, wherein the energy source is located within the housing, wherein the contact surface is coupled to the energy source, and wherein the housing comprises an outer surface that includes the contact surface; and
applying, via the device, when the contact surface is in contact with the outer skin surface of the neck of the patient, an electrical impulse transcutaneously and non-invasively via the contact surface through the outer skin surface of the neck of the patient to a vagus nerve of the patient according to a treatment paradigm, wherein the energy source generates the electrical impulse; and
wherein the treatment paradigm is based at least in part on an application of the electrical impulse as a single dose every 4 to 5 hours during the day.
