# US 11,305,110 B2 · Detection and treatment of obstructive sleep apnea

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- Number: US 11,305,110 B2
- Document ID: US11305110B2
- Status: Granted
- Kind: B2
- Application number: 16/823,476
- Filed: 2020-03-19
- Published: 2020-09-24
- Granted: 2022-04-19
- Earliest claimed: 2019-03-22
- Assignees: Neurostim Technologies LLC
- Applicants: Neurostim Technologies LLC
- Inventors: Hoo-min D. Toong; William C. Altmann
- Web page: https://patentgrep.com/patent/US11305110B2

## CPC

- A61N 1/0548: {Oral electrodes}
- A61B 5/4818: {Sleep apnoea}
- A61B 5/6833: {Adhesive patches}
- A61N 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/3601: {of respiratory organs}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A treatment for obstructive sleep apnea (“OSA”) of a user includes affixing a patch externally on a dermis of the user, the patch including a flexible substrate, an adhesive on a first side adapted to adhere to the dermis of the user, a processor directly coupled to the substrate, and electrodes directly coupled to the substrate. The treatment includes detecting an occurrence of OSA and activating the patch in response to the detecting, the activating including generating an electrical stimuli via the electrodes to activate the genioglossus muscle of the user.

## Claims

### Claim 1

A method of treatment for obstructive sleep apnea (OSA) of a user, the method comprising:
affixing a patch externally on a dermis of the user, the patch comprising a flexible substrate, an adhesive on a first side adapted to adhere to the dermis of the user, a processor directly coupled to the substrate, and electrodes directly coupled to the substrate;
detecting an occurrence of OSA; and
activating the patch in response to the detecting, the activating comprising generating an electrical stimuli via the electrodes to activate a genioglossus muscle of the user, the electrical stimuli comprising square waves having an amplitude between 10 and 100 volts, pulse widths between 100 and 500 microseconds, and a pulse repetition rate of between 2 and 60 pulses per second.

### Claim 2 (depends on 1)

The method of claim 1, a placement of the patch on the user causing the activating to avoid activation of a styloglossus muscle of the user.

### Claim 3 (depends on 2)

The method of claim 2, the placement comprises affixing the patch to a neck of the user on or near a submental triangle of the user.

### Claim 4 (depends on 2)

The method of claim 2, the placement comprises affixing the patch to extend from a neck of the user, across a chin of the user, and ending on a lower lip of the user.

### Claim 5 (depends on 2)

The method of claim 2, the placement comprises affixing the patch to extend from a neck of the user, across a chin of the user, over a lower lip of the user, crossing over lower teeth of the user, and ending at an inner gum line of the user.

### Claim 6 (depends on 2)

The method of claim 2, the placement causing the electrical stimuli to cross axially along a geniohyoid muscle of the user.

### Claim 7 (depends on 1)

The method of claim 1, the electrical stimuli causing a tongue of the user to move.

### Claim 8 (depends on 1)

The method of claim 1, the electrical stimuli comprising a series of pulses with a pattern comprising an intensity and a duration, further comprising adjusting the intensity or the duration of the pattern after each affixing of the patch to the dermis of the user.

### Claim 9 (depends on 8)

The method of claim 8, wherein an applied frequency of the pulses is 2 Hz-50 Hz.

### Claim 10 (depends on 1)

The method of claim 1, the detecting the occurrence of OSA comprising:
measuring a pattern of breathing by a user; and
analyzing the pattern using stored breath limits to determine one or more missed breaths by the user.

### Claim 11 (depends on 10)

The method of claim 10, the detecting the occurrence of OSA based only on the analyzing and using only breathing parameters of the user.

### Claim 12 (depends on 1)

The method of claim 1, the patch comprising one or more sensors, further comprising
placing a tag on or near a target nerve;
receiving an activation signal from the electrodes to a degree proportional to a strength of an activation pulse at the target nerve received by the sensors in response to the electrical stimuli; and
using the activation signal to re-orient a placement of the patch.

### Claim 13

A obstructive sleep apnea (OSA) treatment system comprising:
a patch adapted to be externally applied on a dermis of a user, the patch comprising a flexible substrate, an adhesive on a first side adapted to adhere to the dermis of the user, a processor directly coupled to the substrate, and electrodes directly coupled to the substrate;
the processor, in response to detecting an occurrence of obstructive sleep apnea (OSA), adapted to activate the patch, the activating comprising generating an electrical stimuli via the electrodes to activate a genioglossus muscle of the user, the electrical stimuli comprising square waves having an amplitude between 10 and 100 volts, pulse widths between 100 and 500 microseconds, and a pulse repetition rate of between 2 and 60 pulses per second.

### Claim 14 (depends on 13)

The system of claim 13, the patch adapted to have a placement on the user that causes the activating to avoid activation of a styloglossus muscle of the user.

### Claim 15 (depends on 14)

The system of claim 14, the placement comprises affixing the patch to a neck of the user on or near a submental triangle of the user.

### Claim 16 (depends on 14)

The system of claim 14, the placement comprises affixing the patch to extend from a neck of the user, across a chin of the user, and ending on a lower lip of the user.

### Claim 17 (depends on 14)

The system of claim 14, the placement comprises affixing the patch to extend from a neck of the user, across a chin of the user, over a lower lip of the user, crossing over lower teeth of the user, and ending at an inner gum line of the user.

### Claim 18 (depends on 14)

The system of claim 14, the placement causing the electrical stimuli to cross axially along a geniohyoid muscle of the user.

### Claim 19 (depends on 13)

The system of claim 13, the electrical stimuli adapted to cause a tongue of the user to move.

### Claim 20 (depends on 13)

The system of claim 13, the electrical stimuli comprising a series of pulses with a pattern comprising an intensity and a duration, the processor further adapted to adjust the intensity or the duration of the pattern after each affixing of the patch to the dermis of the user.

### Claim 21 (depends on 13)

The system of claim 13, the patch comprising one or more sensors, the processor further adapted to, in response to placing a tag on or near a target nerve:
receive an activation signal from the electrodes to a degree proportional to a strength of an activation pulse at the target nerve received by the sensors in response to the electrical stimuli; and
use the activation signal to re-orient a placement of the patch.

### Claim 22 (depends on 13)

The system of claim 13, the detecting the occurrence of OSA comprising:
measuring a pattern of breathing by a user; and
analyzing the pattern using stored breath limits to determine one or more missed breaths by the user;
wherein the detecting the occurrence of OSA is based only on the analyzing and using only breathing parameters of the user.
