# US 11,439,818 B2 · Electrical nerve stimulation to treat gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders

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- Number: US 11,439,818 B2
- Document ID: US11439818B2
- Status: Granted
- Kind: B2
- Application number: 16/599,285
- Filed: 2019-10-11
- Published: 2020-02-13
- Granted: 2022-09-13
- 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/US11439818B2

## CPC

- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/36: for stimulation
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61N 2/02: using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence)
- A61N 1/205: {for promoting a biological process}
- 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}
- 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, systems and methods are disclosed for treating or preventing gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders. The devices comprise a housing and an energy source for generating an electric current and transmitting the electric current from the electrode through an interface and the outer skin surface of the patient to a selected nerve fiber within the patient as the interface contacts the outer skin surface. The electric current is sufficient to modulate the selected nerve fiber to at least one of treat or prevent at least one of gastroparesis, functional dyspepsia, or ileus in the patient.

## Claims

### Claim 1

A device comprising:
a housing including a contact surface for contacting an outer skin surface of a patient; and
an energy source housed within the housing, wherein the energy source generates and transmits an electrical impulse through the contact surface and the outer skin surface to a vagus nerve within the patient as the contact surface contacts the outer skin surface, wherein the electrical impulse is sufficient to modulate the vagus nerve to treat post-operative ileus in the patient, wherein the electrical impulse comprises bursts of pulses having a frequency from about 1 burst per second to about 100 bursts per second.

### Claim 2 (depends on 1)

The device of claim 1, wherein each of the pulses has a duration from about 100 microseconds to about 1000 microseconds.

### Claim 3 (depends on 1)

The device of claim 1, wherein each of the pulses has a duration from about 200 microseconds to about 400 microseconds.

### Claim 4 (depends on 1)

The device of claim 1, wherein the electric current generates an electric field at a vagus nerve of the patient above a threshold of 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 a patient.

### Claim 5 (depends on 1)

The device of claim 1 further comprising an electrode within the housing and coupled to the energy source.

### Claim 6 (depends on 4)

The device of claim 4 wherein the inhibitory neurotransmitter includes at least one of a noreprinephrine, a serotonin, or a GABA.

### Claim 7 (depends on 1)

The device of claim 1, wherein the electric current has a frequency from about 1,000 Hz to about 10,000 Hz and a duty cycle from about 1% to about 10%.

### Claim 8 (depends on 7)

The device of claim 7, wherein the frequency of the electric current is from about 4,000 Hz to about 6,000 Hz.

### Claim 9 (depends on 7)

The device of claim 7, wherein the duty cycle is from about 2% to about 5%.

### Claim 10 (depends on 7)

The device of claim 7, wherein the electric current comprises bursts of pulses having a burst duration from about 0.1 milliseconds to about 10 milliseconds and a burst frequency from about 10 Hz to about 50 Hz.

### Claim 11 (depends on 10)

The device of claim 10, wherein the burst duration is from about 2 milliseconds to about 6 milliseconds.