# US 10,478,331 B2 · System, methods and apparatus for delivering nerve stimulation to a patient with physician oversight

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- Number: US 10,478,331 B2
- Document ID: US10478331B2
- Status: Granted
- Kind: B2
- Application number: 15/379,612
- Filed: 2016-12-15
- Published: 2017-05-18
- Granted: 2019-11-19
- Earliest claimed: 2010-12-16
- Assignees: Scion NeuroStim, LLC
- Applicants: Scion Neurostim, LLC
- Inventors: Lesco L. Rogers; Lanty L. Smith; Robert D. Black
- Web page: https://patentgrep.com/patent/US10478331B2

## CPC

- A61F 7/007: {characterised by electric heating}
- A61F 7/12: Devices for heating or cooling internal body cavities
- A61F 2007/0005: {Ears}
- A61F 2007/0075: {using a Peltier element, e.g. near the spot to be heated or cooled}
- A61F 2007/0093: {programmed}
- A61F 2007/0096: {with a thermometer}
- A61F 2007/0295: {for heating or cooling or use at more than one temperature}
- A61F 2007/0296: {Intervals of heating alternated with intervals of cooling}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

The present invention provides devices, systems and methods for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient. In some embodiments, the present invention provides a vestibular stimulation device configured both to generate a prescription for delivering one or more thermal waveforms and to deliver the prescribed thermal waveforms.

## Claims

### Claim 1

A vestibular stimulation device comprising:
an earpiece;
a thermoelectric device (TED) thermally coupled to said earpiece; and
a controller operatively connected to said TED, said controller comprising:
a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; and
a control module configured to activate said TED to deliver the prescribed thermal waveform(s), wherein the prescribed thermal waveform(s) are configured to treat Parkinson's disease in a subject in need of treatment thereof.

### Claim 2 (depends on 1)

The vestibular stimulation device of claim 1, wherein the one or more thermal waveforms are configured to maintain a vestibular stimulation that is sufficient to alter a vestibular phasic firing rate to thereby induce nystagmus over a period of more than three minutes.

### Claim 3 (depends on 1)

The vestibular stimulation device of claim 1, wherein said set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient is stored in a prescription database.

### Claim 4 (depends on 3)

The vestibular stimulation device of claim 3, wherein said prescription database reside(s) in a device selected from the group consisting of a patient control device, a physician control device, a physician support device and a registry.

### Claim 5 (depends on 4)

The vestibular stimulation device of claim 4, wherein said prescription database resides in a registry that comprises prescriptions from at least one of one or more physician control devices and one or more physician support devices.

### Claim 6 (depends on 3)

The vestibular stimulation device of claim 3, wherein said waveform database reside(s) in a device selected from the group consisting of a patient control device, a physician control device, a physician support device and a registry.

### Claim 7 (depends on 1)

The vestibular stimulation device of claim 1, wherein said vestibular stimulation device further comprises a sensor operatively connected to said controller, said sensor configured to transmit data associated with the temperature of the earpiece to said controller.

### Claim 8 (depends on 7)

The vestibular stimulation device of claim 7, wherein said control module is configured to use said data associated with the temperature of the earpiece to ensure that the appropriate one or more thermal waveforms are delivered to the vestibular system and the nervous system of said patient.

### Claim 9 (depends on 8)

The vestibular stimulation device of claim 8, wherein using said data associated with the temperature of the earpiece to ensure that the appropriate one or more thermal waveforms are delivered to at least one of the vestibular system and the nervous system of said patient comprises adjusting an activation signal used to drive said TED responsive to said data associated with the temperature of the earpiece.

### Claim 10 (depends on 9)

The vestibular stimulation device of claim 9, wherein said sensor repeatedly transmits data associated with the temperature of the earpiece to said controller and wherein said controller repeatedly adjusts the activation signal used to drive said TED.

### Claim 11 (depends on 9)

The vestibular stimulation device of claim 9, wherein said controller is configured to shut down if the temperature of the earpiece drops below a low temperature threshold or exceeds a high temperature threshold.

### Claim 12 (depends on 1)

The vestibular stimulation device of claim 1, wherein said controller is configured such that the patient is prevented from at least one of modifying and deleting said prescription.

### Claim 13 (depends on 1)

The vestibular stimulation device of claim 1, wherein the set of instructions for delivering one or more thermal waveforms comprising the prescription includes instructions for providing a plurality of spaced-apart treatment sessions over a defined period of time.

### Claim 14 (depends on 1)

The vestibular stimulation device of claim 1, wherein the set of instructions for delivering one or more thermal waveforms comprising the prescription includes an expiration time after which the controller prohibits delivery of the one or more thermal waveforms.

### Claim 15

A vestibular stimulation device comprising:
an earpiece;
a thermoelectric device (TED) thermally coupled to said earpiece; and
a controller operatively connected to said TED, said controller comprising:
a prescription comprising a set of instructions for delivering one or more thermal waveforms to the vestibular system and/or the nervous system of a patient; and
a control module configured to activate said TED to deliver the prescribed thermal waveform(s), wherein the prescribed thermal waveform(s) are configured to treat headache in a subject in need of treatment thereof.

### Claim 16

A method of delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient, comprising: generating a prescription comprising a set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of said subject; and delivering the prescribed thermal waveform(s) to at least one of the vestibular system and the nervous system of the patient using a vestibular stimulation device,), wherein the prescribed thermal waveform(s) are configured to treat Parkinson's in a subject in need of treatment thereof.

### Claim 17 (depends on 16)

The method of claim 16, wherein the prescribed thermal waveforms are configured to maintain a vestibular stimulation that is sufficient to alter a vestibular phasic firing rate to thereby induce nystagmus over a period of more than three minutes.

### Claim 18

A method of delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of a patient, comprising: generating a prescription comprising a set of instructions for delivering one or more thermal waveforms to at least one of the vestibular system and the nervous system of said subject; and delivering the prescribed thermal waveform(s) to at least one of the vestibular system and the nervous system of the patient using a vestibular stimulation device,), wherein the prescribed thermal waveform(s) are configured to treat headache in a subject in need of treatment thereof.

### Claim 19 (depends on 18)

The method of claim 18, wherein the prescribed thermal waveforms are configured to maintain a vestibular stimulation that is sufficient to alter a vestibular phasic firing rate to thereby induce nystagmus over a period of more than three minutes.

### Claim 20 (depends on 1, 18)

The method of claim 18, wherein said vestibular stimulation device is a vestibular stimulation device according to claim 1.
