# US 12,214,193 B2 · Devices and methods for treating motion sickness using electrical stimulation

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- Number: US 12,214,193 B2
- Document ID: US12214193B2
- Status: Granted
- Kind: B2
- Application number: 18/629,088
- Filed: 2024-04-08
- Published: 2024-08-01
- Granted: 2025-02-04
- Earliest claimed: 2022-05-27
- Assignees: Spark Biomedical, Inc.
- Applicants: Spark Biomedical, Inc.
- Inventors: Alejandro Covalin; Navid Khodaparast; Melanie McWade
- Web page: https://patentgrep.com/patent/US12214193B2

## CPC

- A61N 1/36036: {of the outer, middle or inner ear}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0526: {Head electrodes (A61N1/0551 takes precedence)}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/36139: {with automatic adjustment}
- 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

In an illustrative embodiment, systems and methods for inhibiting, reducing or eliminating motion sickness using a neuromodulation device configured to be worn on a subject's head and a controller configured to deliver therapeutic stimulation pulses for providing motion sickness therapy involve delivering, by the controller, a first series of stimulation pulses to first electrode(s) positioned on or near the subject's ear in a first tissue region to modulate peripheral activity, and delivering, by the controller, a second series of stimulation pulses to second electrode(s) positioned on or near the subject's ear in a second tissue region t to modulate one or more areas in the subject's brain stem.

## Claims

### Claim 1

A system for inhibiting, reducing or eliminating motion sickness using neuromodulation, the system comprising:
a neuromodulation device configured to be worn on a head of a subject, the neuromodulation device comprising
a first conductive surface in electrical communication with at least one first electrode, wherein the first conductive surface is configured for positioning on or near an ear of the subject in a first tissue region, wherein the first tissue region is on, over, or adjacent to one or more first neural structures of a first set of neural structures, and
a second conductive surface in electrical communication with at least one second electrode, wherein the second conductive surface is configured for positioning on or near the ear in a second tissue region on, over or adjacent to one or more second neural structures of a second set of neural structures; and
a controller comprising processing circuitry configured to deliver therapeutic stimulation pulses for providing motion sickness therapy to the subject, wherein delivering the therapeutic stimulation pulses comprises
delivering a first series of stimulation pulses to the at least one first electrode, wherein the first series of stimulation pulses is configured to modulate peripheral activity via modulating central neural autonomic structures, and
delivering a second series of stimulation pulses to the at least one second electrode, wherein the second series of stimulation pulses is configured to modulate one or more areas in a brain stem of the subject.

### Claim 2 (depends on 1)

The system of claim 1, wherein the motion sickness therapy is configured to avoid or minimize a reduction in cognitive skills and motor skills in the subject.

### Claim 3 (depends on 1)

The system of claim 1, further comprising a pulse generator, wherein the pulse generator comprises the controller.

### Claim 4 (depends on 1)

The system of claim 1, wherein the neuromodulation device comprises the controller.

### Claim 5 (depends on 1)

The system of claim 1, wherein modulating the central neural autonomic structures comprises modulating a paraventricular hypothalamic nucleus (PVN) to stimulate increased activity in a pituitary.

### Claim 6 (depends on 1)

The system of claim 1, wherein modulating the peripheral activity comprises producing an increase in peripheral circulating beta-endorphins.

### Claim 7 (depends on 1)

The system of claim 1, wherein modulating the one or more areas in the brain stem comprises modulating a locus coeruleus (LC) to increase availability of central norepinephrine (NE).

### Claim 8 (depends on 7)

The system of claim 7, wherein the second series of stimulation pulses is further configured to modulate activity in a vestibular nuclei (VN).

### Claim 9 (depends on 1)

The system of claim 1, wherein at least one of the first set of neural structures or the second set of neural structures is in direct or indirect communication with an auriculotemporal nerve (ATN).

### Claim 10 (depends on 1)

The system of claim 1, wherein at least one of the first set of neural structures or the second set of neural structures is in direct or indirect communication with an auricular branch of a vagus nerve (ABVN).

### Claim 11 (depends on 1)

The system of claim 1, wherein at least one of the first series of stimulation pulses and the second series of stimulation pulses is configured to increase serotonin (5-HT) availability.

### Claim 12 (depends on 1)

The system of claim 1, wherein:
the first series of stimulation pulses are delivered at one or more low frequencies selected from a first frequency range up to 30 Hertz; and
the second series of stimulation pulses are delivered at i) one or more mid-range frequencies selected from a second frequency range from 31 Hertz to 70 Hertz or ii) one or more high frequencies selected from a third frequency range from 71 Hertz to 150 Hertz.

### Claim 13 (depends on 1)

The system of claim 1, further comprising:
one or more sensors, each sensor configured to generate feedback signals indicative of physical movements of a) the subject and/or b) the neuromodulation device;
wherein the processing circuitry is configured to
analyze the feedback signals of the one or more sensors to identify one or more situational triggers indicative of likelihood of motion sickness, and
initiate the motion sickness therapy responsive to the analyzing identifying at least one situational trigger of the one or more situational triggers.

### Claim 14 (depends on 13)

The system of claim 13, wherein the one or more sensors comprises at least one of a motion detector, an accelerometer, or a gyroscope.

### Claim 15 (depends on 13)

The system of claim 13, wherein the neuromodulation device comprises at least a portion of the one or more sensors.

### Claim 16 (depends on 13)

The system of claim 13, wherein the one or more situational triggers comprise at least one of exposure to G-forces, exposure to turbulence, flying in a position where the head and torso of the subject are in a substantially non-vertical and/or upside-down orientation, or exposure to choppiness and/or swells while on or in water.

### Claim 17 (depends on 1)

The system of claim 1, wherein:
one or more electrodes of the at least one first electrode is configured to be placed behind an auricle of the ear; and
a given neural structure of the one or more first neural structures is an auricular branch of the vagus nerve (ABVN) near a point at which the ABVN surfaces through a mastoid canaliculus (MsC).

### Claim 18 (depends on 1)

The system of claim 1, wherein:
one or more electrodes of the at least one second electrode is placed forward of an auricle of the ear; and
a given neural structure of the one or more second neural structures corresponding to the placement of the one or more electrodes is a branch of an auriculotemporal nerve (ATN).

### Claim 19 (depends on 1)

The system of claim 1, wherein:
a housing of the neuromodulation device is formed as a protective helmet; or
at least a portion of the neuromodulation device is coupled to the protective helmet.

### Claim 20 (depends on 1)

The system of claim 1, wherein treating the motion sickness comprises treating spatial disorientation.
