# US 11,027,116 B2 · System and method for ear-arranged transcutaneous vagus nerve stimulation

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- Number: US 11,027,116 B2
- Document ID: US11027116B2
- Status: Granted
- Kind: B2
- Application number: 15/778,344
- Filed: 2016-11-23
- Published: 2018-11-29
- Granted: 2021-06-08
- Earliest claimed: 2015-11-23
- Assignees: The General Hospital Corporation
- Applicants: The General Hospital Corporation
- Inventors: Jian Kong
- Web page: https://patentgrep.com/patent/US11027116B2

## CPC

- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- 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 1/0472: {Structure-related aspects}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 1/36036: {of the outer, middle or inner ear}
- A61N 1/37: Monitoring; Protecting
- A61M 2021/0027: {by the hearing sense}
- A61M 2021/0055: {with electric or electro-magnetic fields}
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- 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)}

## Abstract

A transcutaneous nerve stimulation system includes a multifunctional earphone assembly that receives a sound signal from a sound source or other sources (such as a signal generator). An amplifier receiving the sound signal from the sound source or independent signal generator amplifies the sound signal to generate an amplified electrical signal. A stimulator, which includes multiple conductive electrode contacts, is coupled to the amplifier to receive the amplified electrical signal. The electrode contacts may protrude from an earbud/headphone or extend from an adjustable probe arm. The amplified electrical signal is used to apply electrical stimulation while the earphone assembly emits audible sounds according to the sound signal. The combined functionality enhances compliance with treatment regimens involving electrical stimulation of vagus nerves and other regions of a subject. Potential indications include, without limitation, major depressive disorder, epilepsy, chronic pain, pre-diabetes, insomnia, cardiovascular disorders, tinnitus, autism, daily stress, and anxiety.

## Claims

### Claim 1

A transcutaneous peripheral nerve stimulation system comprising:
an amplifier configured to receive a sound signal from a sound source and amplify the sound signal to generate an amplified electrical signal; and
an earphone assembly including:
a listening unit including a speaker configured to receive the sound signal and emit audio according to the sound signal;
a stimulator coupled to the amplifier, the stimulator being configured to apply, as audio is emitted from the speaker, the amplified electrical signal from the amplifier to transcutaneously electrically stimulate a peripheral nerve of a subject; and
a probe arm extending from the listening unit, the probe arm branching into first and second prongs at a distal end thereof, wherein first and second electrode contacts extend from the first and second prongs, respectively, of the probe arm;
wherein the probe arm is coupled to the listening unit via a first rotary joint, the probe arm being rotatable about a first axis defined by the probe arm; and
wherein the first and second prongs are coupled to the probe arm at a second rotary joint such that the first and second prongs together rotate about a second axis.

### Claim 2 (depends on 1)

The system of claim 1 wherein the earphone assembly includes a headphone having left and right listening portions, each listening portion having at least one electrode situated at an inner side, and an adjusting mechanism situated at an outer side opposing the inner side, each adjusting mechanism being configured to adjust an angle of the respective electrode.

### Claim 3 (depends on 2)

The system of claim 2 further including left and right privacy covers placed over the adjusting mechanisms of the left and right listening portion, respectively, so as to conceal the adjusting mechanism.

### Claim 4 (depends on 1)

The system of claim 1 wherein the earphone assembly is configured to receive the sound signal directly from the sound source that provides the sound signal that is amplified by the amplifier.

### Claim 5 (depends on 1)

The system of claim 1 wherein:
the earphone assembly further includes a listening unit sized to be at least partially received in an ear canal of a subject;
the stimulator protrudes from the listening unit; and
the earphone assembly is configured such that when the listening unit is in an ear canal of a subject, the stimulator is positionable to reach and electrically stimulate a vagus or other nerve of a subject.

### Claim 6 (depends on 1)

The system of claim 1 wherein the stimulator includes at least first and second electrode contacts extending radially outwardly from the earphone assembly.

### Claim 7 (depends on 1)

The system of claim 1 wherein:
the earphone assembly further includes a listening unit and a probe arm extending from the listening unit; and
the stimulator includes a first electrode contact protruding from a distal end of the probe arm, and a second electrode contact protruding from the listening unit.

### Claim 8 (depends on 1)

The system of claim 1 wherein the stimulator includes at least one electrode contact having a conductive elastomer.

### Claim 9 (depends on 1)

The system of claim 1 wherein:
the earphone assembly further includes a listening unit and a probe unit coupled to the listening unit; and
the stimulator is at least partially incorporated in the probe unit; and
a separation between the listening unit and the probe unit is adjustable.

### Claim 10 (depends on 9)

The system of claim 9 further including a shaft extending between the listening unit and the probe unit, wherein the separation between the listening unit and the probe unit is adjustable by retractable insertion of the shaft into one or both of the listening and probe units.

### Claim 11 (depends on 1)

The system of claim 1 wherein the amplifier is incorporated in the earphone assembly.

### Claim 12 (depends on 1)

The system of claim 1 further including a control module configured to control at least one of a frequency and a magnitude of the amplified electrical signal to modulate stimulation applied by the stimulator, wherein the amplifier is incorporated in the control module.

### Claim 13 (depends on 1)

The system of claim 1 further including a filter configured to only allow frequencies within a predetermined range to be amplified by the amplifier to generate the amplified electrical signal.

### Claim 14 (depends on 1)

The system of claim 1 further including a sound source outputting the sound signal received by the amplifier.

### Claim 15

A transcutaneous peripheral nerve stimulation method comprising:
receiving a sound signal from a sound source;
amplifying the sound signal using an amplifier to generate an amplified electrical signal;
emitting audio according to the sound signal using a speaker in a listening unit;
as audio is emitted from the listening unit, transcutaneously electrically stimulating a peripheral nerve of a subject by applying the amplified electrical signal using a stimulator coupled to the amplifier;
wherein the listening unit includes a probe arm extending therefrom, the probe arm branching into first and second prongs at a distal end thereof, wherein first and second electrode contacts extend from the first and second prongs, respectively, of the probe arm;
wherein the probe arm is coupled to the listening unit via a first rotary joint, the probe arm being rotatable about a first axis defined by the probe arm, and wherein the first and second prongs are coupled to the probe arm at a second rotary joint such that the first and second prongs together rotate about a second axis.

### Claim 16

A transcutaneous peripheral nerve stimulation system comprising:
a sound signal input port configured to receive a sound signal from a sound source;
an amplifier configured to amplify the sound signal received via the sound signal input port to generate an amplified electrical signal;
a listening unit having a speaker for emitting audio, and a stimulator coupled to the listening unit; and
a controller configured to:
emit audio through the speaker according to the sound signal received via the sound signal input port; and
simultaneously apply the amplified electrical signal to the stimulator so as to transcutaneously electrically stimulate a peripheral nerve of a subject; and
wherein the listening unit includes a probe arm extending therefrom, the probe arm branching into first and second prongs at a distal end thereof, wherein first and second electrode contacts extend from the first and second prongs, respectively, of the probe arm;
wherein the probe arm is coupled to the listening unit via a first rotary joint, the probe arm being rotatable about a first axis defined by the probe arm, and wherein the first and second prongs are coupled to the probe arm at a second rotary joint such that the first and second prongs together rotate about a second axis.

### Claim 17 (depends on 16)

The system of claim 16 wherein the first and second prongs separated by a gap.