# US 12,178,966 B2 · Systems and methods for treating neurological disorders

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- Number: US 12,178,966 B2
- Document ID: US12178966B2
- Status: Granted
- Kind: B2
- Application number: 17/117,463
- Filed: 2020-12-10
- Published: 2021-10-28
- Granted: 2024-12-31
- Earliest claimed: 2018-06-22
- Assignees: Nocira, LLC
- Applicants: Nocira, LLC
- Inventors: David Mager George; John Patrick Claude; Kevin E. Willey; Andy Edward Denison; Darrin James Kent
- Web page: https://patentgrep.com/patent/US12178966B2

## CPC

- A61F 7/0085: {Devices for generating hot or cold treatment fluids}
- 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
- A61F 7/00: Heating or cooling appliances for medical or therapeutic treatment of the human body (hyperthermia using electric or magnetic fields or ultrasound A61N)
- A61H 9/0078: {with intermittent or alternately inflated bladders or cuffs (mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776)}
- A61M 13/003: {Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing}
- A61F 2007/0005: {Ears}
- A61F 2007/0054: {with a closed fluid circuit, e.g. hot water}
- A61F 2007/0071: {using a resistor, e.g. near the spot to be heated}
- A61F 2007/0086: {with a thermostat}
- A61F 2007/0093: {programmed}
- A61H 9/0071: {by localized pressure, e.g. air streams or jets}
- A61H 2201/0207: heated
- A61H 2201/0214: cooled
- A61H 2201/0242: by a fluid circulating in the apparatus
- A61H 2201/1238: with hydraulic or pneumatic drive
- A61H 2201/165: Wearable interfaces
- A61H 2201/5007: computer controlled
- A61H 2201/5071: Pressure sensors
- A61H 2201/5082: Temperature sensors
- A61H 2201/5097: wireless
- A61H 2205/027: Ears
- A61M 2021/0022: {by the tactile sense, e.g. vibrations}
- A61M 2021/0044: {by the sight sense}
- A61M 2021/0066: {with heating or cooling}
- A61M 2021/0072: {with application of electrical currents}
- A61M 2202/02: Gases
- A61M 2202/0468: non-physiological
- A61M 2205/07: having air pumping means
- A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3368: Temperature
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/3606: cooled
- A61M 2205/362: by gas flow
- A61M 2205/364: by chemical reaction
- A61M 2205/3653: by Joule effect, i.e. electric resistance
- A61M 2205/3673: thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
- A61M 2205/368: by electromagnetic radiation, e.g. IR waves
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/581: by audible feedback
- A61M 2205/583: by visual feedback
- A61M 2205/8206: battery-operated
- A61M 2209/088: on the body
- A61M 2210/0668: Middle ear
- A61M 2230/50: Temperature
- 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)
- 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)}
- 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)

## Abstract

Caloric stimulation and pressure stimulation can be applied to the ear for treatment of neurological disorders, such as migraine, pain, and headache. Heat can be applied first to increase the sensitivity of the mechanoreceptors in the ear. The pressure can be applied after heating to produce a stronger neurological response than would occur without the heating. In some cases, cooling can be used. Valves can be used to direct fluid flow to a right ear, a left ear, or both. Valves can be used to transition the system between an irrigation or caloric mode and a pressure mode. Green eyewear can be used for therapeutic relief.

## Claims

### Claim 1

A treatment system comprising:
an earpiece;
a fluid flow generator;
a fluid conduit extending between the fluid flow generator and the earpiece;
an outlet valve; and
a controller configured to:
operate the treatment system in an irrigation mode by:
opening the outlet valve; and
operating the fluid flow generator to apply a flow of fluid through the fluid conduit, through the earpiece, and out the outlet valve to an ambient area; and
operate the treatment system in a pressure mode by:
closing the outlet valve; and
operating the fluid flow generator to apply a pressure differential between an external ear canal pressure and an ambient pressure.

### Claim 2 (depends on 1)

The treatment system of claim 1, wherein the earpiece comprises an outer surface configured to sealably engage an external ear canal sufficiently to provide a barrier between the external ear canal pressure and the ambient pressure, and wherein the treatment system is configured to transition between the irrigation mode and the pressure mode while the earpiece remains sealably engaged with the external ear canal.

### Claim 3 (depends on 1)

The treatment system of claim 1, further comprising a temperature modifier, wherein the controller is configured to operate the temperature modifier to change a temperature of the fluid during the irrigation mode.

### Claim 4 (depends on 3)

The treatment system of claim 3, wherein the controller is configured to operate the treatment system in the pressure mode after operating the treatment system in the irrigation mode to heat the external ear canal.

### Claim 5 (depends on 3)

The treatment system of claim 3, wherein the temperature modifier comprises a heater.

### Claim 6 (depends on 1)

The treatment system of claim 1, wherein a second fluid conduit extends between the earpiece and the outlet valve.

### Claim 7 (depends on 6)

The treatment system of claim 6, comprising a valve module that includes the outlet valve, wherein the fluid conduit extends through the valve module.

### Claim 8 (depends on 1)

The treatment system of claim 1, wherein the outlet valve comprises an outlet check valve configured to permit fluid to flow through the outlet valve to the ambient area and to impede fluid from flowing from the ambient area in through the outlet valve.

### Claim 9 (depends on 1)

The treatment system of claim 1, comprising a pressure sensor, wherein the controller is configured to use information from the pressure sensor for feedback control to implement a pressure treatment profile.

### Claim 10 (depends on 1)

The treatment system of claim 1, comprising a valve module that includes the outlet valve, wherein the valve module further comprises an inlet check valve configured to permit fluid to flow from an ambient environment into the valve module in the irrigation mode.

### Claim 11 (depends on 1)

The treatment system of claim 1, comprising an actuator configured to open and close the outlet valve in response to electrical signals.

### Claim 12 (depends on 1)

The treatment system of claim 1, further comprising:
an additional earpiece for use in an additional ear; and
an additional fluid conduit extending between the fluid flow generator and the additional earpiece.

### Claim 13 (depends on 12)

The treatment system of claim 12, wherein the controller is configured to:
open the outlet valve and operate the fluid flow generator to apply a flow of fluid through the additional fluid conduit, through the additional earpiece, and out the outlet valve to an ambient area in the irrigation mode; and
close the outlet valve and operate the fluid flow generator to apply a pressure differential between an external ear canal pressure of the additional ear and the ambient pressure in the pressure mode.

### Claim 14 (depends on 12)

The treatment system of claim 12, having a first configuration that directs fluid flow toward the earpiece while impeding fluid flow toward the additional earpiece, and having a second configuration that directs fluid flow to the additional earpiece while impeding fluid flow to the earpiece.

### Claim 15 (depends on 14)

The treatment system of claim 14, having a third configuration that directs fluid flow toward both the earpiece and the additional earpiece.

### Claim 16 (depends on 14)

The treatment system of claim 14, comprising an actuator configured to transition the outlet valve between the first configuration and the second configuration in response to electrical signals.
