# US 11,077,019 B2 · Auricular peripheral nerve field stimulator and method of operating same

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- Number: US 11,077,019 B2
- Document ID: US11077019B2
- Status: Granted
- Kind: B2
- Application number: 16/408,004
- Filed: 2019-05-09
- Published: 2019-08-29
- Granted: 2021-08-03
- Earliest claimed: 2013-10-22
- Assignees: Innovative Health Solutions, Inc.
- Applicants: Innovative Health Solutions, Inc.
- Inventors: Christopher R. Brown; Gary M. Peterson
- Web page: https://patentgrep.com/patent/US11077019B2

## CPC

- A61H 39/002: {Using electric currents (electrotherapy A61N1/32)}
- A61H 39/02: Devices for locating such points
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/0502: {Skin piercing electrodes}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/36036: {of the outer, middle or inner ear}
- A61N 1/36135: {using physiological parameters}
- A61H 2201/5005: for controlling frequency distribution, modulation or interference of a driving signal
- A61H 2201/5007: computer controlled
- A61H 2201/5023: Interfaces to the user
- A61H 2201/5033: having a fixed single program
- A61H 2201/5038: freely programmable by the user
- A61H 2201/5058: Sensors or detectors
- A61H 2205/027: Ears
- A61H 2230/105: used as a control parameter for the apparatus
- A61H 2230/405: used as a control parameter for the apparatus
- A61H 2230/505: used as a control parameter for the apparatus
- A61H 2230/605: used as a control parameter for the apparatus
- A61N 1/0526: {Head electrodes (A61N1/0551 takes precedence)}
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- 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

An auricular peripheral nerve field stimulator includes at least one therapy electrode configured for percutaneous insertion into an auricle of a human ear near at least one neurovascular bundle, and an electrical stimulation device electrically coupled to the at least one therapy electrode, the electrical stimulation device programmed to (i) generate and deliver electrical stimulation signals to the inserted at least one therapy electrode at a selected frequency for a selected duration to stimulate at least one auricular peripheral nerve field within the auricle, and (ii) repeat (i) with the stimulation signals having a modulated frequency.

## Claims

### Claim 1

An auricular peripheral nerve field stimulator, comprising:
at least one therapy electrode configured for percutaneous insertion into an auricle of a human ear near at least one neurovascular bundle located therein, and
an electrical stimulation device electrically coupled to the electrical stimulation device, the electrical stimulation device programmed to (i) generate and deliver electrical stimulation signals to the percutaneously inserted at least one therapy electrode at a selected frequency for a first duration to stimulate at least one auricular peripheral nerve field within the auricle, and (ii) to repeat (i) with the electrical stimulation signals having a modulated frequency.

### Claim 2 (depends on 1)

The auricular peripheral nerve field stimulator of claim 1, wherein the electrical stimulation device is further programmed at (i) to, following expiration of the first duration, control the electrical stimulation device to generate no electrical stimulation signals for a second duration.

### Claim 3 (depends on 1)

The auricular peripheral nerve field stimulator of claim 1, further comprising means for attaching the housing to or adjacent to the human ear.

### Claim 4 (depends on 1)

The auricular peripheral nerve field stimulator system of claim 1, further comprising one of a battery and an accumulator electrically coupled to the electrical stimulation device to supply the electrical stimulation device with electrical energy.

### Claim 5 (depends on 1)

The auricular peripheral nerve field stimulator of claim 1, further comprising a remote control device,
wherein operation of the electrical stimulator device is controllable via the remote control device.

### Claim 6 (depends on 1)

The auricular nerve field stimulation device of claim 1, wherein the electrical stimulation device is configured to generate the electrical stimulation signals with a constant current amplitude.

### Claim 7 (depends on 1)

The auricular nerve field stimulation device of claim 1, further comprising a reference electrode electrically coupled to the electrical stimulation device and configured for percutaneous insertion into a skin surface of or near the human ear, the reference electrode providing a reference for the electrical stimulation signals.

### Claim 8 (depends on 2)

The auricular nerve field stimulation device of claim 2, wherein electrical stimulation device is further programmed to repeat (i) and (ii) multiple times over a total therapy duration.

### Claim 9 (depends on 1)

The auricular nerve field stimulation device of claim 1, wherein the at least one therapy electrode includes at least one needle for percutaneous insertion into the auricle.

### Claim 10 (depends on 1)

The auricular nerve field stimulation device of claim 1, wherein the at least one therapy electrode comprises a plurality of therapy electrodes each electrically coupled to the electrical stimulation device and each including at least one needle for percutaneous insertion into the auricle.

### Claim 11

A method for auricular peripheral nerve field stimulation, the method comprising:
locating at least one auricular neurovascular bundle within an auricle of a human ear,
percutaneously inserting at least one needle, carried by at least one therapy electrode, into the auricle near the at least one located auricular neurovascular bundle,
electrically coupling an electrical stimulation device to the at least needle of the at least one therapy electrode, and
controlling the electrical stimulation device to (i) generate and deliver electrical stimulation signals to the percutaneously inserted at least one needle at a selected frequency for a first duration to stimulate at least one auricular peripheral nerve field within the auricle, and (ii) repeat (i) with the electrical stimulation signals having a modulated frequency.

### Claim 12 (depends on 11)

The method of claim 11, wherein (i) further comprises, following expiration of the first duration, controlling the electrical stimulation device to generate no electrical stimulation signals for a second duration.

### Claim 13 (depends on 11)

The method of claim 11, wherein percutaneously inserting the at least one needle carried by the at least one therapy electrode into the auricle comprises percutaneously inserting the at least one needle into a ventral or dorsal aspect of the auricle within about 2 mm of the located neurovascular bundle.

### Claim 14 (depends on 11)

The method of claim 11, further comprising controlling operation of the electrical stimulation device with a remote control device.

### Claim 15 (depends on 11)

The method of claim 11, further comprising controlling the electrical stimulation device to generate the electrical stimulation signals with constant current amplitude.

### Claim 16 (depends on 11)

The method of claim 11, further comprising providing a reference for the electrical stimulation signals with a reference electrode electrically coupled to the electrical stimulation device and configured for percutaneous insertion into a skin surface on or near the human ear.

### Claim 17 (depends on 12)

The method of claim 12, further comprising repeating (i) and (ii) multiple times over a total therapy duration.

### Claim 18 (depends on 11)

The method of claim 11, wherein (i) comprises controlling the electrical stimulation device to generate and deliver the electrical stimulation signals in the form of a pulse train having a repetition frequency of at least one of +1 Hz, −1 Hz, +10 Hz and −10 Hz.

### Claim 19 (depends on 11)

The method of claim 11, wherein (i) and (ii) comprise controlling the electrical stimulation device to generate and deliver the electrical stimulation signals in the form of a pulse train having a repetition frequency of between about 0.5 Hz to 100 Hz.

### Claim 20 (depends on 11)

The method of claim 11, wherein percutaneously inserting at least one needle comprises inserting at least one needle of each of a plurality of therapy electrodes into the auricle near one or more located auricular neurovascular bundles within the auricle,
wherein electrically coupling an electrical stimulation device to the at least needle comprises electrically coupling the electrical stimulation device to the at least one needle of each of the plurality of therapy electrodes,
and wherein controlling the electrical stimulation device to generate and deliver electrical stimulation signals to the percutaneously inserted at least one needle comprises controlling the electrical stimulation device to generate and deliver electrical stimulation signals to the percutaneously inserted at least one needle of each of the plurality of therapy electrodes.