# US 10,945,665 B1 · Oral data collection device

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- Number: US 10,945,665 B1
- Document ID: US10945665B1
- Status: Granted
- Kind: B1
- Application number: 17/022,630
- Filed: 2020-09-16
- Published: 2021-03-18
- Granted: 2021-03-16
- Earliest claimed: 2019-09-16
- Assignees: Hoot Medical Analytics, Inc.
- Applicants: HOOT Medical Analytics, Inc.
- Inventors: Travis Tran; Konstantine Trichas
- Web page: https://patentgrep.com/patent/US10945665B1

## CPC

- A61B 5/682: {Mouth, e.g., oral cavity; tongue; Lips; Teeth}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/082: {Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath (A61B5/083, A61B5/091 take precedence)}
- A61B 5/1114: {Tracking parts of the body}
- A61B 5/14539: {for measuring pH}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/228: {of masticatory organs, e.g. detecting dental force}
- A61B 5/4812: {Detecting sleep stages or cycles}
- A61B 5/4818: {Sleep apnoea}
- A61B 5/4842: {Monitoring progression or stage of a disease}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/4875: {Hydration status, fluid retention of the body}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/7278: {Artificial waveform generation or derivation, e.g. synthesizing signals from measured signals}
- A61B 5/7465: {Arrangements for interactive communication between patient and care services, e.g. by using a telephone network (telemetry of measured physiological signal A61B5/0002)}
- A61C 19/04: Measuring instruments specially adapted for dentistry ({A61C5/44 takes precedence; testing vitality of teeth A61B5/0534;} radiation diagnosis specially adapted for dentistry A61B6/51)
- A61B 2560/0214: of power generation or supply
- A61B 2562/0204: Acoustic sensors
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- A61B 2562/0223: Magnetic field sensors
- A61B 2562/0247: Pressure sensors
- A61B 2562/0271: Thermal or temperature sensors
- A61B 2562/029: Humidity sensors
- A61B 2562/043: in a linear array
- A61B 2562/06: Arrangements of multiple sensors of different types
- A61C 7/08: Mouthpiece-type retainers {or positioners, e.g. for both the lower and upper arch (arch-shaped medicament applicators for teeth or gums A61C19/063; mouthguards for protecting the teeth of sportsmen A63B71/085)}
- A61C 2204/005: using chip tag or any electronic identification mean, e.g. RFID
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)

## Abstract

The present disclosure provides an oral data collection device comprising a mouthguard and at least two sensors, a medical analytics system comprising the device, and methods of using the device and system to provide a personalized treatment protocol, stage a health condition, measure a response to therapy, phenotype for selection to participate in drug trials, measure stability of an anatomical structure, or predict a rate of change of a health condition in a subject in need thereof.

## Claims

### Claim 1

An oral data collection device, comprising:
a. a mouthguard, the mouthguard comprising:
i. an arch-shaped body comprising a proximal end, a first distal end, and a second distal end, an external surface, an internal surface, a first biting surface, and a tray operable to engage the upper or lower teeth of a subject, the tray comprising a second biting surface opposite the first biting surface;
b. sensors in the body of the mouthguard, the sensors comprising:
i. a first pressure sensor stack at the first distal end of the mouthguard and a second pressure sensor stack at the second distal end of the mouthguard, wherein each pressure sensor stack comprises a first pressure sensor and a second pressure sensor arranged in a stack;
ii. a humidity sensor operable to sense relative humidity in the breath of a user wearing the device; and
iii. a microphone or vibration sensor;
c. a controller in the body of the mouthguard, wherein the controller is in functional communication with the sensors, and wherein the controller is operable to receive and communicate sensor data;
d. a means for communication in the body of the mouthguard, wherein the means for communication is operable to receive the sensor data from the controller and communicate the sensor data to a secondary device; and
e. a power source functionally coupled to the controller and the one or more sensors;
wherein each pressure sensor is a force plate pressure sensor, and
wherein the controller is configured to receive data from each pressure sensor, and extrapolate the received data to obtain velocity of movement (m/s), power (Watts), displacement (Meters), temporal parameters (seconds), and left/right asymmetry for bilateral systems.

### Claim 2 (depends on 1)

The device of claim 1, wherein each pressure sensor is operable to measure shear forces.

### Claim 3 (depends on 1)

The device of claim 1, wherein the first sensor of each pressure sensor stack is operable to sense the biting pressure of a bottom molar, and the second sensor of each pressure sensor stack is operable to sense the biting pressure of a top molar.

### Claim 4 (depends on 1)

The device of claim 1, wherein a sensing surface of the humidity sensor is at the internal surface off center of the proximal end of the mouthguard.

### Claim 5 (depends on 1)

The device of claim 1, further comprising an oxygen sensor, a nine-axis inertial sensor, a pH or other biochemical sensor, or combinations thereof.

### Claim 6 (depends on 5)

The device of claim 5, wherein the nine-axis inertial sensor is enclosed in the body of the mouthguard, and comprises a three-axis magnetometer, a three-axis accelerometer, and a three-axis gyroscope, the three-axis magnetometer operable to provide a reference plane in relation to earth's magnetic field for the three-axis accelerometer and the three-axis gyroscope, wherein the nine-axis inertial sensor is adapted to sense a position and movement of the head and body of a user.

### Claim 7 (depends on 5)

The device of claim 5, wherein the temperature sensor, humidity sensor, and oxygen sensor are an integrated temperature, humidity, and oxygen sensor.

### Claim 8 (depends on 5)

The device of claim 5, wherein the microphone or vibration sensor is enclosed in an acoustic chamber in the body of the mouthguard.

### Claim 9 (depends on 1)

The device of claim 1, wherein the means of communication comprises a transmitter operable to communicate sensor data to the secondary device wirelessly using a wireless communication protocol.

### Claim 10 (depends on 1)

The device of claim 1, wherein the secondary device is a desktop computer, a mobile computing device, a wearable device, a personal digital assistant, a computing device with no user interface, a cloud computing platform, or a combination thereof.

### Claim 11 (depends on 1)

The device of claim 1, wherein the device further comprises a protective compartment housing one or more of the sensors, the controller, the means for communication, and the power source.

### Claim 12 (depends on 1)

A medical analytics system comprising:
a. an oral data collection device of claim 1; and
b. a secondary device comprising at least one processor and associated memory adapted to receive sensor data collected by the data collection device, and instructions which when executed by the at least one processor, cause the at least one processor to:
i. interpret the sensor data obtained from a subject into descriptive factors indicative of a health condition of the subject; and
ii. output the descriptive factors.

### Claim 13 (depends on 12)

The system of claim 12, wherein the descriptive factors indicative of a health condition of the subject comprise hydration, breathing patterns, body temperature, body and head position, body and head movement, clenching of the jaws, sleep phase, and nighttime mouth position.

### Claim 14 (depends on 12)

The system of claim 12, wherein the secondary device further comprises instructions which when executed by the at least one processor, cause the at least one processor to provide a personalized treatment protocol, stage a health condition, measure a response to therapy, phenotype for selection to participate in drug trials, measure stability of an anatomical structure, or predict a rate of change of a health condition in the subject.

### Claim 15 (depends on 1)

A method of determining a personalized treatment protocol, staging a given health condition, measuring response to therapy, phenotyping for selection to participate in drug trials, measuring stability of an anatomical structure, or predicting rate of change of a health condition in a subject in need thereof, the method comprising:
a. providing or having provided the device of claim 1 to the subject for wearing by the subject during sleep; and
b. interpret the sensor data obtained from the subject into descriptive factors indicative of a health condition of the subject to determine the personalized treatment protocol, stage the given health condition, measure response to therapy, phenotype for selection to participate in drug trials, measure stability of an anatomical structure, or predict rate of change of a given health condition in the subject.

### Claim 16 (depends on 15)

The method of claim 15, wherein the method further comprises providing a secondary device comprising at least one processor and associated memory adapted to receive sensor data collected by the data collection device, and instructions which when executed by the at least one processor, cause the at least one processor to:
a. interpret the sensor data obtained from the subject into descriptive factors indicative of a health condition of the subject; and
b. output the descriptive factors.

### Claim 17 (depends on 16)

The method of claim 16, wherein the descriptive factors indicative of a health condition of the subject comprise hydration, breathing patterns, body temperature, body and head position, body and head movement, clenching of the jaws, sleep phase, and nighttime mouth position.

### Claim 18 (depends on 16)

The method of claim 16, wherein the secondary device further comprises instructions which when executed by the at least one processor, cause the at least one processor to provide the personalized treatment protocol, stage the health condition, measure the response to therapy, phenotype for selection to participate in drug trials, measure stability of an anatomical structure, or predict the rate of change of a health condition in the subject.