# US 8,874,227 B2 · Devices and methods for non-invasive capacitive electrical stimulation and their use for vagus nerve stimulation on the neck of a patient

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- Number: US 8,874,227 B2
- Document ID: US8874227B2
- Status: Granted
- Kind: B2
- Application number: 13/183,765
- Filed: 2011-07-15
- Published: 2011-11-10
- Granted: 2014-10-28
- Earliest claimed: 2009-03-20
- Assignees: ElectroCore, Inc.
- Applicants: Bruce J. Simon; Joseph P. Errico; John T. Raffle
- Inventors: Bruce J. Simon; Joseph P. Errico; John T. Raffle
- Web page: https://patentgrep.com/patent/US8874227B2

## CPC

- A61N 1/36021: {for treatment of pain}
- A61M 21/00: Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0496: {characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 11/02: Nasal agents, e.g. decongestants
- A61P 11/06: Antiasthmatics
- A61P 11/08: Bronchodilators
- A61P 13/02: of urine or of the urinary tract, e.g. urine acidifiers
- A61P 13/10: of the bladder
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/06: Antimigraine agents
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61M 2021/0022: {by the tactile sense, e.g. vibrations}
- A61M 2021/0027: {by the hearing sense}
- A61M 2021/0044: {by the sight sense}
- A61M 2021/0072: {with application of electrical currents}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A non-invasive electrical stimulator shapes an elongated electric field of effect that can be oriented parallel to a long nerve, such as a vagus nerve in a patient's neck, producing a desired physiological response in the patient. The stimulator comprises a source of electrical power, at least one electrode and a continuous electrically conducting medium in contact with the electrodes. The conducting medium is also in contact with an interface element that may conform to the contour of a target body surface of the patient when the interface element is applied to that surface. When the interface element is made of insulating (dielectric) material, and disclosed stimulation waveforms are used, the power source need not supply high voltage, in order to capacitively stimulate the target nerve. The stimulator is configured to produce a peak pulse that is sufficient to produce a physiologically effective electric field in the vicinity of a target nerve, but not to substantially stimulate other nerves and muscles that lie in the vicinity of the target nerve and patient's skin.

## Claims

### Claim 1

A device for applying energy transcutaneously to a target nerve within a patient comprising:
a handheld enclosure having an interface comprised of a dielectric material on at least a portion of an outer surface of the handheld enclosure, the interface having an inner surface and an outer surface;
a source of energy for generating an electric field in the vicinity of a target nerve;
an electrode housed within the enclosure and coupled to the source of energy, wherein the electrode is electrically coupled to the inner surface of the interface; and
wherein the source of energy is configured for applying an electrical impulse to the electrode such that the electrical field is capacitively coupled across the interface and the outer surface of the patient's skin to generate an electrical impulse at the target nerve within the patient sufficient to modulate the target nerve.

### Claim 2 (depends on 1)

The device of claim 1 wherein the source of energy is configured to generate the electrical impulse by applying a voltage of less than 600 volts to the electrode.

### Claim 3 (depends on 2)

The device of claim 2 wherein the voltage is less than 100 volts.

### Claim 4 (depends on 2)

The device of claim 2 wherein the voltage is less than 50 volts.

### Claim 5 (depends on 1)

The device of claim 1 wherein the dielectric material has a dielectric constant greater than 3.

### Claim 6 (depends on 1)

The device of claim 1 wherein the dielectric material is Mylar.

### Claim 7 (depends on 1)

The device of claim 1 wherein the electrical field comprises bursts of pulses with a frequency of about 5 to about 100 bursts per second.

### Claim 8 (depends on 7)

The device of claim 7 wherein the pulses are full sinusoidal waves.

### Claim 9 (depends on 1)

The device of claim 1 wherein the electrical field comprises bursts of between 1 and 20 pulses with each pulse about 50-1000 microseconds in duration.

### Claim 10 (depends on 1)

The device of claim 1 wherein the electrical field has an amplitude of greater than 10 V/m.

### Claim 11 (depends on 1)

The device of claim 1 wherein the electrical field has a gradient of greater than 2 V/m/mm.

### Claim 12 (depends on 1)

The device of claim 1 wherein the electrical impulse is sufficient to generate an action potential in a nerve fiber within the target nerve.

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 1)

The device of claim 1 wherein the target nerve is located at least 1-2 cm beneath the outer surface of the patient's skin.

### Claim 15 (depends on 1)

The device of claim 1 where the target nerve is located at least 2-5 cm beneath the outer surface of the patient's skin.

### Claim 16 (depends on 1)

The device of claim 1 further comprising a conducting medium coupling the electrode to the interface.

### Claim 17 (depends on 16)

The device of claim 16 wherein the conducting medium comprises an electrically conductive gel.

### Claim 18 (depends on 1)

The device of claim 1 further comprising a handheld housing enclosing the source of energy and the electrode, wherein the interface comprises a surface of the handheld housing.

### Claim 19

A method for the transcutaneous capacitive stimulation of a target nerve within a patient comprising:
positioning a first surface of a dielectric interface of a device adjacent to a skin surface of the patient;
positioning one or more electrodes adjacent to a second surface of the dielectric interface, the second surface opposite the first surface;
generating an electric field with the device such that one or more electrical impulses are capacitively coupled across the dielectric interface and transmitted to the target nerve, the electrical impulses being sufficient to modulate electrophysiological signals in the target nerve.

### Claim 20 (depends on 19)

The method of claim 19 wherein the electrical impulses contain effective Fourier components at frequencies greater than 1 kHz.

### Claim 21 (depends on 19)

The method of claim 19 wherein the generating step is carried out by producing a voltage of less than 100 volts at an electrode within the device.

### Claim 22 (depends on 19)

The method of claim 19 wherein the voltage is less than 50 volts.

### Claim 23 (depends on 19)

The method of claim 19 wherein the dielectric material has a dielectric constant greater than 3.

### Claim 24 (depends on 19)

The method of claim 19 wherein the dielectric interface comprises Mylar.

### Claim 25 (depends on 19)

The method of claim 19 wherein the electrical impulses comprise bursts of pulses with a frequency of about 5 to about 100 bursts per second.

### Claim 26 (depends on 19)

The method of claim 19 wherein the electrical impulses are full sinusoidal waves.

### Claim 27 (depends on 19)

The method of claim 19 wherein the electrical impulses comprises bursts of between 1 and 20 pulses with each pulse about 50-1000 microseconds in duration.

### Claim 28 (depends on 19)

The method of claim 19 wherein the target nerve is a vagus nerve.

### Claim 29 (depends on 19)

The method of claim 19 further comprising electrically coupling the interface to an electrode with an electrically conductive medium.

### Claim 30 (depends on 29)

The method of claim 29 wherein the electrically conductive medium comprises a conductive gel.

### Claim 31

A method for applying energy to a target nerve within a patient comprising:
generating a first electric charge on an inside surface of a dielectric patient contact surface on a handheld device; and
inducing a second electric charge from the first electric charge on an outside surface of the dielectric patient contact surface such that the second electric charge is transmitted to the target nerve with sufficient energy to modulate said target nerve.

### Claim 32 (depends on 31)

The method of claim 31 wherein the target nerve is a vagus nerve.