WO2017070343A1 - Intelligent fitness and sports mouthguard - Google Patents

Intelligent fitness and sports mouthguard Download PDF

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Publication number
WO2017070343A1
WO2017070343A1 PCT/US2016/057908 US2016057908W WO2017070343A1 WO 2017070343 A1 WO2017070343 A1 WO 2017070343A1 US 2016057908 W US2016057908 W US 2016057908W WO 2017070343 A1 WO2017070343 A1 WO 2017070343A1
Authority
WO
WIPO (PCT)
Prior art keywords
mouthguard
intelligent
axis
sensor
processing unit
Prior art date
Application number
PCT/US2016/057908
Other languages
French (fr)
Inventor
Yong Kyu YOON
Justin M. CORRELL
Todd R. SCHUMANN
Sheng-po FANG
Fong WONG
Original Assignee
The University Of Florida Research Foundation, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The University Of Florida Research Foundation, Inc. filed Critical The University Of Florida Research Foundation, Inc.
Priority to US15/769,584 priority Critical patent/US11109808B2/en
Publication of WO2017070343A1 publication Critical patent/WO2017070343A1/en

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Classifications

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    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6814Head
    • A61B5/682Mouth, e.g., oral cavity; tongue; Lips; Teeth
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    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002Monitoring the patient using a local or closed circuit, e.g. in a room or building
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    • A61B5/0205Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055Simultaneously evaluating both cardiovascular condition and temperature
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Definitions

  • LoC consciousness
  • Embodiments of the present disclosure are related to intelligent mouthguards that can be used in fitness and sport activities.
  • an intelligent mouthguard system comprises a mouthguard including a nine-axis inertial sensor comprising a three-axis magnetometer, a three-axis accelerometer and a three-axis gyroscope, and an internal module in
  • the three-axis magnetometer is configured to provide a reference plane in relation to the earth's magnetic field for the three-axis accelerometer and the three-axis gyroscope and the internal module is configured to provide sensor data corresponding to the three-axis magnetometer, the three-axis accelerometer and the three-axis gyroscope to an external processing unit when located in an oral cavity, and the external processing unit communicatively coupled to the mouthguard.
  • the external processing unit can be a master device communicatively coupled to the mouthguard via a Bluetooth® link.
  • the master device can be a smartphone.
  • the master device can be configured to provide an indication of acceleration experienced by a wearer of the mouthguard through a user interface rendered on the master device.
  • the master device can be configured to adjust the acceleration based upon the reference plane provided by the three-axis magnetometer.
  • the external processing unit can be a communication interface module communicatively coupled to the mouthguard and communicatively coupled to a remotely located processing device.
  • the communication interface module can be communicatively coupled to the mouthguard via a Bluetooth® link and communicatively coupled to the remotely located processing device via a WLAN link.
  • the internal module can be configured to transmit the sensor data from the three-axis magnetometer, the three-axis accelerometer and the three-axis gyroscope to the external processing unit.
  • the sensor data can be transmitted to the external processing unit in realtime.
  • the internal module can transmit the sensor data to the external processing unit from memory in response to a transmission request received from the external processing unit.
  • the intelligent mouthguard system comprises a temperature sensor.
  • the intelligent mouthguard system comprises an infrared (IR) sensor, wherein heart rate or blood pressure can be determined based upon sensor data from the IR sensor.
  • the intelligent mouthguard system comprises a strain gauge sensor sealed in the mouthguard.
  • the strain gauge sensor can comprise a polydimethylsiloxane (PDMS) and carbon nanofiber (CNF) composite sensing element.
  • the sensing element can comprise electrospun polymer derived conductive carbon nanofiber (EPD-CNF) sealed in polydimethylsiloxane (PDMS).
  • FIGS. 1A, 1 B, and 1C illustrate an example of an intelligent mouthguard, in accordance with various embodiments of the present disclosure.
  • FIG. 1 D includes images of examples of custom and general intelligent mouthguards, in accordance with various embodiments of the present disclosure.
  • FIGS. 2A and 2B illustrate an example of a composite material strain gauge sensor, in accordance with various embodiments of the present disclosure.
  • FIG. 2C illustrates an example of fabrication of a strain gauge sensor using electrospun polymer derived conductive carbon nanofiber (EPD-CNF) and
  • FIGS. 2D and 2E are images of the carbon nanofiber embedded in the PDMS, in accordance with various embodiments of the present disclosure.
  • FIGS. 2F and 2G illustrate test results of the EPD-CNF/PDMS stain sensor, in accordance with various embodiments of the present disclosure.
  • FIGS. 3A and 3B illustrate a prototype mouthguard of FIGS. 1 A and 1 B, and master device in communication with the mouthguard, in accordance with various embodiments of the present disclosure.
  • the device presented here is a smart mouthguard platform with 1 1 sensor channels and a friendly user interface.
  • the mouthguard platform is targeted for use in all fitness and sports activities where the user is interested in monitoring their biometric data from physical activity and their potential exposure to life threatening (head, heat, and heart related) injury.
  • the oral cavity is a region that offers easy access and noninvasive device placement. Further, the same platform can be extended for use in bruxism monitoring and intervention.
  • the smart mouthguard can provide real-time feedback to the user(s) or a designated official or healthcare professional. In the case of bruxism, it offers the ability to implement intervention mechanisms such as a muscle massager, heating pad and/or behavior modification through biofeedback.
  • the sports mouthguard can implement a 9-axis inertial sensor and pressure sensors to detect dangerous force levels to which the head is subjected to, an infrared (IR) sensor for heart pulse rate and osmolality monitoring, and a temperature sensor to detect dangerous rises in core body temperature.
  • IR infrared
  • a bruxism mouthguard can implement different sensitivity pressure sensors to detect biting force from "chattering" to clenching, an inertial sensor to detect restlessness, and a thermistor to detect rises in body temperature.
  • FIG. 1A shown is a graphical representation illustrating an example of an intelligent mouthguard 100 including sensors, a battery, charging and wireless electronics circuitry.
  • the intelligent mouthguard system comprises a printed circuit board 103 embedded in a mouthguard 100 and a software application that enables low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server.
  • FIG. 1 B shown is an example of the printed circuit board 103, which contains a plurality of sensors 106 (e.g., a 9-axis inertial sensor 106a, a temperature sensor 106b, an infrared (IR) optical sensor 106c, etc.) used to track user activity and/or condition.
  • a microcontroller 109 can be configured to communicate with each of the sensors and to communicate various information to the external hub or server.
  • the biometric data collected from the sensor can provide the user with biometric information from physical activity and exposure to head, heat, and heart-related injuries.
  • the software application can provide a unique user interface to interact with the mouthguard 100 and to display the acquired biometric data and injury exposure information. Further, the software application can be connected to a back-end server interface located on a remote storage device.
  • the printed circuit board 103 comprises an ARM Cortex microprocessor 109 with an integrated Bluetooth Low Energy (BLE) 2.4GHz transceiver such as the Silicon Labs Blue Gecko BGM11 1.
  • BLE Bluetooth Low Energy
  • the Bluetooth Special Interest group outlines the communication protocol employed by BLE enabled devices as a master - peripheral relationship.
  • the ARM Cortex BLE microprocessor 109 fulfills the peripheral role and collects the data from several sensors 106 located on the circuit board 103.
  • the data can be transmitted to an external processing unit 1 12 such as a master device, e.g., a more powerful smart phone (Android or iPhone), tablet, laptop computer, or other computing device, where it can be processed and/or provided for display, or a communication interface module that can forward the data to a remotely located processing device for processing, display and/or storage.
  • a master device e.g., a more powerful smart phone (Android or iPhone), tablet, laptop computer, or other computing device
  • a communication interface module that can forward the data to a remotely located processing device for processing, display and/or storage.
  • the printed circuit board 103 maintains the smallest electrical footprint to be sufficient for integration into the mouthguard 100.
  • This mouthguard platform provides for non-invasive and easy access to a number of biological markers and/or signals via, for example, salivary analysis.
  • FIG. 1 C shown is an example of a sensor network of a intelligent mouthguard 100.
  • Signals from one or more sensors 106 mounted on the printed circuit board 103 and/or in the mouthguard 100 may be received by a sensor front end circuit (e.g., a M UX/ADC) for processing by the microprocessor 109.
  • the microprocessor 109 can provide the acquired sensor data to the master device 1 12 through a transceiver, which may be integrated into the microprocessor 109 or may be a separate device.
  • the printed circuit board 103 and/or microprocessor 109 can include memory to store sensor data for subsequent transmission to the master device 1 12 and/or code or instructions that may be executed by the microprocessor 109.
  • the master device 1 12 includes a transceiver that receives the transmitted sensor information and provides it to a processor for analysis and processing. Transmission between the mouthguard 100 and the master device 1 12 may be over a wireless communications link (e.g., Bluetooth®, WiFi, WLAN, etc.).
  • a wireless communications link e.g., Bluetooth®, WiFi, WLAN, etc.
  • the mouthguard 100 can also be referred to as the H 3 mouthguard as it deals with head, heat, and heart-related injuries.
  • the mouthguard 100 is a multifunctional smart oral platform that offers real time biometric monitoring including potential danger detection and real time compliance reporting.
  • FIG. 1 D shows examples of customized and general mouthguards 100 with the printed circuit board 103, sensors, battery, and charging circuitry encased in a protective coating.
  • the mouthguard 100 can be loaded with 1 1 sensor nodes which track various biomarkers such as, e.g., core body temperature, heart rate, blood pressure, and impact parameters.
  • the system application can be extended by the addition of pressure sensors to find applications in bruxism monitoring.
  • the 9-axis inertial sensor 106a of FIG. 1 B can include a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer such as in an InvenSense MPU-9250.
  • the accelerometer can provide gravitational force data
  • the gyroscope can provide rotational data about an axis
  • the magnetometer can provide a reference plane in relation to the earth's magnetic field.
  • the 9-axis of data can be used to create a three-dimensional (3-D) mapping of the mouthguard 100 that tracks the forces and direction of perturbations that the user experiences during physical activity. Both magnitude and direction of an impact force on the head can be detected and recorded.
  • the temperature sensor 106b of FIG. 1 B can be, e.g., a diode type located in the microcontroller silicon, an external low-power temperature sensor such as the Texas Instruments LM94022 multi-gain sensor, or other appropriate type of temperature sensor.
  • the LM94022 is well suited to source the input of a sample and hold analog-to-digital converter (ADC) signals similar to the analog inputs on the Silicon Labs BGM1 11.
  • ADC analog-to-digital converter
  • the temperature sensor can be implemented to record oral temperatures, providing potential heat related injury alerts in advance.
  • the mouthguard 100 is not limited to only analog temperature sensors but could be loaded with a digital sensor with serial output.
  • the mouthguard 100 is not limited to a single sensor, but can use several sensors to provide a differential measurement to improve accuracy in identifying the user's core body temperature.
  • An infrared (IR) sensor 106c such as the Silicon Labs Si1147 can be used to provide heart rate and blood pressure
  • the Si1 147 comprises an IR LED and a CMOS ambient light sensor module. A portion of the infrared light projected into microvascular tissue is absorbed. Further, as the microvascular tissues expand and contract, the IR absorption changes. The ambient light sensor captures the changes and an algorithm can be used to resolve the data into a heart rate and blood pressure measurement.
  • the IR sensor information can be used to track body condition and fitness level, which can be evaluated in real-time or stored (e.g., in the smartphone) for subsequent access.
  • the mouthguard 100 can include pressure sensors, such as capacitors with a compressible dielectric layer. As a force is applied, the effective thickness of the dielectric layer changes causing a change in capacitance. This change can be measured by detecting a change in the time constant for an RC circuit or the center frequency of an LC circuit and the relative force can be extracted. These sensors are linear for a limited range of force, and so sensors with different deflection coefficients can be used to create an array of sensors which can linearly measure the entire range of biting force for either bruxism or impact force for concussion detection.
  • the mouthguard 100 can also include a strain gauge pressure sensor, which can be used for biting force measurement. Biting during Bruxism produces a pressure of about 100 lbs to 200 lbs (or about 2000 kPa). Hence, the sensor should be able to withstand this pressure level with a reasonable resolution.
  • a strain gauge pressure sensor various options are available. For example, two options include:
  • a commercially available strain gauge sensor like a match stick type strain gauge such as a pressure sensor like SCP 100 (120 kPa range) from VTI technologies, and pressure membrane.
  • FIG. 2A is a schematic diagram illustrating the PDMS/CNF sensor and FIG. 2B is an image showing a fabricated PDMS/CNF sensor.
  • the PDMS/CNF sensor or FIG. 2B can be made of electrospun polymer (e.g., SU-8) derived conductive carbon nanofiber (EPD-CNF) and PDMS.
  • EPD-CNF/PDMS composite exhibits strong piezoresistivity that translates into excellent sensitivity with an extremely high gauge factor of 23.1 , which is about 12-30 times higher than produced by graphene nanoribbon or carbon nanotube based nanocomposite sensors.
  • the EPD-CNF/PDMS composite offers a low cost, high sensitivity sensor that can be manufactured and incorporated into the mouthguard 100.
  • the composite remains intact under high mechanical strain, such as occurs during use, which may be attributed to the continuous and tangled electrospun nanofibers in the sensor.
  • the strain sensor can be embedded in a side or bottom surface of the mouthguard 100 and communicatively coupled to the microprocessor 109 on the printed circuit board 103.
  • FIG. 2C illustrates an example of the fabrication of the composite sensor.
  • SU-8 nanofibers can be electrospun (A) on a silicon (Si) wafer and patterned (B) using photolithography. When deposited, the electrospun nanofibers form a continuous and randomly oriented layer that form a microscale spring. Carbonization (C) of the electrospun nanofibers enables the formation of stretchable conductive EPD-CNF within the embedding elastomers.
  • the EPD-CNF can then be partially embedded (D) in PDMS and separated (E) from the Si wafer.
  • Connectors can be assembled (F) on the EPD-CNF, which are then sealed (G) in PDMS as shown.
  • FIG. 2D is a scanning electron microscope (SEM) image of carbonized nanofibers and FIG. 2E shows a cross-sectional view of the EPD-CNF embedded within the PDMS.
  • FIG. 2F shows the measured current-voltage (i-V) curves for strain sensors of FIG. 2B including EPD-CNFs that were carbonized at 900°C and 1000°C.
  • the measuring setup is shown in inset of FIG. 2F.
  • the extracted sheet resistances (Rs) of those carbonized nanofibers at 900°C and 1000°C were 830kQ/n and 50kQ/n, respectively, where ⁇ / ⁇ is ohms per square.
  • the mouthguard 100 can include a battery and charging circuit for wireless power delivery to the circuit board 103.
  • Power can be delivered between a transmitter and a receiver located in the mouthguard 100 by inductive coupling between the antennas 809.
  • the charging circuit can be part of a wireless power delivery system configured to supply power to the battery through inductive coupling.
  • the delivered power may then be regulated by the charging circuit for delivery to loads on the circuit board 103 and/or sensors in the mouthguard 100.
  • BQ5001 10 and BQ51013 ICs from Texas Instruments Inc. may be used as the transmitter and the receiver, respectively, with near field power coupling provided through antennas. Since the
  • BQ500110 and BQ51013 ICs are highly integrated chips, nearly no peripherals are needed on the mouthguard 100 for power collection.
  • the mouthguard 100 can be extended to support team applications.
  • a software application deployed on a trainer's tablet (or other computing device) can communicate with and take measurements from a plurality of mouthguards 100 by pinging each individually to transfer their data to prevent channel crowding.
  • the microcontroller 109 can transfer data to internal memory and/or external memory on the circuit board 103 during acquisition, and then transfer the stored information in response to the ping requesting transfer.
  • the 434 MHz or 915 MHz ISM frequency bands can be used to implement a multi-layer system that includes an additional wireless module.
  • the communication interface module 112 can either be located in the player's helmet or other equipment worn by the player, or integrated into the players clothing. Further, an external patch, which can be secured to the equipment and/or player, could be used for implementation of the communication interface module 112.
  • the additional wireless module or communication interface 112 (external) can communicate using both 2.4 GHz (to mouthguard 100) and ISM bands (434 MHz or 915 MHz) as a virtual waypoint between the close range mouthguard 100 and externally located transceiver module located on the sideline or in coach's booth.
  • FIG. 3A shown is an image of a prototype mouthguard 100 and a smartphone acting as the master device 1 12.
  • the image shows example of an interface of the system application that is implemented on the smartphone.
  • the interface allows a user to access the sensor information (e.g., accelerometer, gyroscope, magnetometer, temperature sensors, etc.).
  • FIG. 3B illustrates an example of the sensor information that can be displayed on the master device.
  • the information e.g., biometric data
  • the interface can also facilitate file transfer of the recorded sensor information from the mouthguard 100 to the master device 112 or to another externally located processing device, as described above.
  • the interface can also allow the master device 112 to be disconnected from the mouthguard 100, allowing another device to connect as the master device.
  • the intelligent mouthguard 100 utilizes wearable electronics as part of a self- fitness monitoring system with wireless connectivity. Wearable electronics for fitness and wellness can help individuals monitor physical activity, diet, and sleep with continuous updates of biometric data.
  • the mouthguard 100 can include a detection mechanism that can provide awareness of vital signs and potential sustained injury.
  • the design and fabrication of the H 3 (Head, Heat, and Heart- Related) mouthguard platform with 1 1 sensor channels and a friendly user interface has been presented.
  • the device can be used in all sports or fitness activities where the user is interested in their biometric data from physical activity and their potential exposure to life threatening (head) injury.
  • the H 3 mouthguard platform is not limited to applications in sports fitness and wellness, but could find similar applications in the public safety (firefighter) and military sectors.
  • the concept can be further extended to a smart denture or retainer with a detection capability of diabetes, HIV, and cancer biomarkers from saliva and an integrated drug delivery functionality.
  • the mouthguard 100 is in good contact with saliva, which contains lots of biomarkers for health and disease monitoring and detection, the H 3 mouthguard 100 can be extended to be used as a general health monitoring and intervention tool.
  • the H 3 mouthguard 100 offers a multifunctional smart oral platform with real time biometric monitoring that includes potential danger detection and real time compliance report.
  • the mouthguard 100 can be loaded with a plurality of sensor nodes, which track core body temperature, heart rate, blood pressure, impact parameters and/or other biometric indications.
  • a temperature sensor 106b (FIG. 1 B) can be used to measure the body temperature inside the mouth, eliminating inaccuracies found in common external wearable devices that arise from the temperature gradient between the skin and environment.
  • An infrared sensor 106c (FIG. 1 B) can be included to provide heart rate and blood pressure measurements using photoplethysmography (PPG), an optical technique that detects blood volume changes in microvascular tissues.
  • PPG photoplethysmography
  • Impact parameters can be tracked using a 9-axis inertial sensor 106a (FIG. 1 B) including a 3-axis accelerometer, 3-axis gyroscope, and 3-axis magnetometer.
  • the 3-axis magnetometer uses the earth's magnetic field to allow the sensing algorithm to compensate for drift errors over longer periods of time thus providing a more accurate measurement of impacts from a lateral force and angular momentum.
  • the H 3 mouthguard 100 development includes electronics and firmware design, form factor integration, and software development.
  • the device can provide accurate biometric analysis that can inform the user of their fitness level and exposure to risk of heat or impact related injuries. Functionalities include head impact detection (e.g., serious impact alerts and/or long term impact tracking), body temperature monitoring (e.g., potential injury alerts such as for heat stroke or dehydration), and vital sign tracking (e.g., personal fitness tracking).
  • ratios, concentrations, amounts, and other numerical data may be expressed herein in a range format. It is to be understood that such a range format is used for convenience and brevity, and thus, should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited.
  • a concentration range of "about 0.1 % to about 5%” should be interpreted to include not only the explicitly recited concentration of about 0.1 wt% to about 5 wt%, but also include individual concentrations (e.g., 1 %, 2%, 3%, and 4%) and the sub-ranges (e.g., 0.5%, 1 .1 %, 2.2%, 3.3%, and 4.4%) within the indicated range.
  • the term “about” can include traditional rounding according to significant figures of numerical values.
  • the phrase “about 'x' to 'y'” includes “about 'x' to about 'y" ⁇

Abstract

Various examples are provided for intelligent mouthguards that can be used in fitness and sport activities. In one example, an intelligent mouthguard system includes a mouthguard including sensors and an internal module in communication with the sensors. The sensors can include a nine-axis inertial sensor comprising a three-axis magnetometer, a three-axis accelerometer and a three-axis gyroscope. The three-axis magnetometer can provide a reference plane in relation to the earth's magnetic field for the three-axis accelerometer and the three-axis gyroscope. The internal module can provide sensor data to an external processing unit when located in an oral cavity.

Description

INTELLIGENT FITNESS AND SPORTS MOUTHGUARD
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to, and the benefit of, co-pending U.S. provisional application entitled "Intelligent Fitness and Sports Mouthguard" having serial no. 62/245,580, filed October 23, 2015, the entirety of which is hereby incorporated by reference. This application is also related to co-pending U.S. patent application entitled
"MULTIFUNCTIONAL ORAL PROSTHETIC SYSTEM" having serial no. 14/347,951 , filed March 27, 2014, the entirety of which is hereby incorporated by reference.
BACKGROUND
[0002] Concern has increased about injuries that occur during sporting activities. In particular, head traumas that can result in concussion have come under greater scrutiny. According to the US Centers for Disease Control and Prevention (CDC), more than 3.8 million sports brain injuries occur per year with 300 thousand resulting in loss of
consciousness (LoC). These injuries are not limited to occurrence at the professional or collegiate level, but also include an estimated number of 250 thousand sports brain injuries occurring at the high school level. Diagnosis and treatment of such injuries can be enhanced by monitoring athletes during the sporting events.
SUMMARY
[0003] Embodiments of the present disclosure are related to intelligent mouthguards that can be used in fitness and sport activities.
[0004] In one embodiment, among others, an intelligent mouthguard system comprises a mouthguard including a nine-axis inertial sensor comprising a three-axis magnetometer, a three-axis accelerometer and a three-axis gyroscope, and an internal module in
communication with the nine-axis inertial sensor. The three-axis magnetometer is configured to provide a reference plane in relation to the earth's magnetic field for the three- axis accelerometer and the three-axis gyroscope and the internal module is configured to provide sensor data corresponding to the three-axis magnetometer, the three-axis accelerometer and the three-axis gyroscope to an external processing unit when located in an oral cavity, and the external processing unit communicatively coupled to the mouthguard. In one or more aspects of these embodiments, the external processing unit can be a master device communicatively coupled to the mouthguard via a Bluetooth® link. The master device can be a smartphone. The master device can be configured to provide an indication of acceleration experienced by a wearer of the mouthguard through a user interface rendered on the master device. The master device can be configured to adjust the acceleration based upon the reference plane provided by the three-axis magnetometer.
[0005] In one or more aspects of these embodiments, the external processing unit can be a communication interface module communicatively coupled to the mouthguard and communicatively coupled to a remotely located processing device. The communication interface module can be communicatively coupled to the mouthguard via a Bluetooth® link and communicatively coupled to the remotely located processing device via a WLAN link. The internal module can be configured to transmit the sensor data from the three-axis magnetometer, the three-axis accelerometer and the three-axis gyroscope to the external processing unit. The sensor data can be transmitted to the external processing unit in realtime. The internal module can transmit the sensor data to the external processing unit from memory in response to a transmission request received from the external processing unit.
[0006] In one or more aspects of these embodiments, the intelligent mouthguard system comprises a temperature sensor. The intelligent mouthguard system comprises an infrared (IR) sensor, wherein heart rate or blood pressure can be determined based upon sensor data from the IR sensor. The intelligent mouthguard system comprises a strain gauge sensor sealed in the mouthguard. The strain gauge sensor can comprise a polydimethylsiloxane (PDMS) and carbon nanofiber (CNF) composite sensing element. The sensing element can comprise electrospun polymer derived conductive carbon nanofiber (EPD-CNF) sealed in polydimethylsiloxane (PDMS).
[0007] Other systems, methods, features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims. In addition, all optional and preferred features and modifications of the described embodiments are usable in all aspects of the disclosure taught herein. Furthermore, the individual features of the dependent claims, as well as all optional and preferred features and modifications of the described embodiments are combinable and interchangeable with one another.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.
[0009] FIGS. 1A, 1 B, and 1C illustrate an example of an intelligent mouthguard, in accordance with various embodiments of the present disclosure.
[0010] FIG. 1 D includes images of examples of custom and general intelligent mouthguards, in accordance with various embodiments of the present disclosure.
[0011] FIGS. 2A and 2B illustrate an example of a composite material strain gauge sensor, in accordance with various embodiments of the present disclosure.
[0012] FIG. 2C illustrates an example of fabrication of a strain gauge sensor using electrospun polymer derived conductive carbon nanofiber (EPD-CNF) and
polydimethylsiloxane (PDMS), in accordance with various embodiments of the present disclosure. [0013] FIGS. 2D and 2E are images of the carbon nanofiber embedded in the PDMS, in accordance with various embodiments of the present disclosure.
[0014] FIGS. 2F and 2G illustrate test results of the EPD-CNF/PDMS stain sensor, in accordance with various embodiments of the present disclosure.
[0015] FIGS. 3A and 3B illustrate a prototype mouthguard of FIGS. 1 A and 1 B, and master device in communication with the mouthguard, in accordance with various embodiments of the present disclosure.
DETAILED DESCRIPTION
[0016] Disclosed herein are various embodiments related to an intelligent mouthguard for fitness and sport activities. Reference will now be made in detail to the description of the embodiments as illustrated in the drawings, wherein like reference numbers indicate like parts throughout the several views.
[0017] In this Internet of Things (loT) era, there is a great deal of interest in wearable devices with wireless functionality that are networked together to provide up-to-date realtime data to a central hub such as a cell phone, personal computer, or network server. The device presented here is a smart mouthguard platform with 1 1 sensor channels and a friendly user interface. The mouthguard platform is targeted for use in all fitness and sports activities where the user is interested in monitoring their biometric data from physical activity and their potential exposure to life threatening (head, heat, and heart related) injury. The oral cavity is a region that offers easy access and noninvasive device placement. Further, the same platform can be extended for use in bruxism monitoring and intervention. The smart mouthguard can provide real-time feedback to the user(s) or a designated official or healthcare professional. In the case of bruxism, it offers the ability to implement intervention mechanisms such as a muscle massager, heating pad and/or behavior modification through biofeedback.
[0018] The devices focus on providing a holistic approach to health monitoring by using an array of sensors to cover a complete application instead of a single sensor. For example, the sports mouthguard can implement a 9-axis inertial sensor and pressure sensors to detect dangerous force levels to which the head is subjected to, an infrared (IR) sensor for heart pulse rate and osmolality monitoring, and a temperature sensor to detect dangerous rises in core body temperature. A bruxism mouthguard can implement different sensitivity pressure sensors to detect biting force from "chattering" to clenching, an inertial sensor to detect restlessness, and a thermistor to detect rises in body temperature.
[0019] Referring to FIG. 1A, shown is a graphical representation illustrating an example of an intelligent mouthguard 100 including sensors, a battery, charging and wireless electronics circuitry. The intelligent mouthguard system comprises a printed circuit board 103 embedded in a mouthguard 100 and a software application that enables low-energy wireless communications (e.g., Bluetooth®, WiFi, WLAN, etc.) between the electronics in the mouthguard 100 and an external hub or server. Referring to FIG. 1 B, shown is an example of the printed circuit board 103, which contains a plurality of sensors 106 (e.g., a 9-axis inertial sensor 106a, a temperature sensor 106b, an infrared (IR) optical sensor 106c, etc.) used to track user activity and/or condition. A microcontroller 109 can be configured to communicate with each of the sensors and to communicate various information to the external hub or server.
[0020] The biometric data collected from the sensor can provide the user with biometric information from physical activity and exposure to head, heat, and heart-related injuries. The software application can provide a unique user interface to interact with the mouthguard 100 and to display the acquired biometric data and injury exposure information. Further, the software application can be connected to a back-end server interface located on a remote storage device.
[0021] In the example of FIG. 1 B, the printed circuit board 103 comprises an ARM Cortex microprocessor 109 with an integrated Bluetooth Low Energy (BLE) 2.4GHz transceiver such as the Silicon Labs Blue Gecko BGM11 1. The Bluetooth Special Interest group outlines the communication protocol employed by BLE enabled devices as a master - peripheral relationship. In this case, the ARM Cortex BLE microprocessor 109 fulfills the peripheral role and collects the data from several sensors 106 located on the circuit board 103. The data can be transmitted to an external processing unit 1 12 such as a master device, e.g., a more powerful smart phone (Android or iPhone), tablet, laptop computer, or other computing device, where it can be processed and/or provided for display, or a communication interface module that can forward the data to a remotely located processing device for processing, display and/or storage. In this setup, the printed circuit board 103 maintains the smallest electrical footprint to be sufficient for integration into the mouthguard 100. This mouthguard platform provides for non-invasive and easy access to a number of biological markers and/or signals via, for example, salivary analysis.
[0022] Referring next to FIG. 1 C, shown is an example of a sensor network of a intelligent mouthguard 100. Signals from one or more sensors 106 mounted on the printed circuit board 103 and/or in the mouthguard 100 may be received by a sensor front end circuit (e.g., a M UX/ADC) for processing by the microprocessor 109. The microprocessor 109 can provide the acquired sensor data to the master device 1 12 through a transceiver, which may be integrated into the microprocessor 109 or may be a separate device. The printed circuit board 103 and/or microprocessor 109 can include memory to store sensor data for subsequent transmission to the master device 1 12 and/or code or instructions that may be executed by the microprocessor 109. The master device 1 12 includes a transceiver that receives the transmitted sensor information and provides it to a processor for analysis and processing. Transmission between the mouthguard 100 and the master device 1 12 may be over a wireless communications link (e.g., Bluetooth®, WiFi, WLAN, etc.).
[0023] The mouthguard 100 can also be referred to as the H3 mouthguard as it deals with head, heat, and heart-related injuries. The mouthguard 100 is a multifunctional smart oral platform that offers real time biometric monitoring including potential danger detection and real time compliance reporting. FIG. 1 D shows examples of customized and general mouthguards 100 with the printed circuit board 103, sensors, battery, and charging circuitry encased in a protective coating. The mouthguard 100 can be loaded with 1 1 sensor nodes which track various biomarkers such as, e.g., core body temperature, heart rate, blood pressure, and impact parameters. The system application can be extended by the addition of pressure sensors to find applications in bruxism monitoring.
[0024] 9-axis Inertial Sensors. The 9-axis inertial sensor 106a of FIG. 1 B can include a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer such as in an InvenSense MPU-9250. The accelerometer can provide gravitational force data, the gyroscope can provide rotational data about an axis, and the magnetometer can provide a reference plane in relation to the earth's magnetic field. Together, the 9-axis of data can be used to create a three-dimensional (3-D) mapping of the mouthguard 100 that tracks the forces and direction of perturbations that the user experiences during physical activity. Both magnitude and direction of an impact force on the head can be detected and recorded.
[0025] Temperature Sensor. The temperature sensor 106b of FIG. 1 B can be, e.g., a diode type located in the microcontroller silicon, an external low-power temperature sensor such as the Texas Instruments LM94022 multi-gain sensor, or other appropriate type of temperature sensor. The LM94022 is well suited to source the input of a sample and hold analog-to-digital converter (ADC) signals similar to the analog inputs on the Silicon Labs BGM1 11. The temperature sensor can be implemented to record oral temperatures, providing potential heat related injury alerts in advance. The mouthguard 100 is not limited to only analog temperature sensors but could be loaded with a digital sensor with serial output. The mouthguard 100 is not limited to a single sensor, but can use several sensors to provide a differential measurement to improve accuracy in identifying the user's core body temperature.
[0026] Heart Rate and Blood Pressure Sensor. An infrared (IR) sensor 106c such as the Silicon Labs Si1147 can be used to provide heart rate and blood pressure
measurements using photoplethysmography (PPG), an optical technique that detects blood volume changes in microvascular tissues. The Si1 147 comprises an IR LED and a CMOS ambient light sensor module. A portion of the infrared light projected into microvascular tissue is absorbed. Further, as the microvascular tissues expand and contract, the IR absorption changes. The ambient light sensor captures the changes and an algorithm can be used to resolve the data into a heart rate and blood pressure measurement. The IR sensor information can be used to track body condition and fitness level, which can be evaluated in real-time or stored (e.g., in the smartphone) for subsequent access.
[0027] Capacitive Pressure Sensor. The mouthguard 100 can include pressure sensors, such as capacitors with a compressible dielectric layer. As a force is applied, the effective thickness of the dielectric layer changes causing a change in capacitance. This change can be measured by detecting a change in the time constant for an RC circuit or the center frequency of an LC circuit and the relative force can be extracted. These sensors are linear for a limited range of force, and so sensors with different deflection coefficients can be used to create an array of sensors which can linearly measure the entire range of biting force for either bruxism or impact force for concussion detection.
[0028] Strain Gauge Pressure Sensor. The mouthguard 100 can also include a strain gauge pressure sensor, which can be used for biting force measurement. Biting during Bruxism produces a pressure of about 100 lbs to 200 lbs (or about 2000 kPa). Hence, the sensor should be able to withstand this pressure level with a reasonable resolution. For the strain gauge sensor, various options are available. For example, two options include:
• A commercially available strain gauge sensor like a match stick type strain gauge, such as a pressure sensor like SCP 100 (120 kPa range) from VTI technologies, and pressure membrane.
• An engineered composite material made of polydimethylsiloxane (PDMS) and carbon nanofiber (CNF) considering size constraints and biocompatibility issues is used. FIG. 2A is a schematic diagram illustrating the PDMS/CNF sensor and FIG. 2B is an image showing a fabricated PDMS/CNF sensor.
[0029] In some implementations, the PDMS/CNF sensor or FIG. 2B can be made of electrospun polymer (e.g., SU-8) derived conductive carbon nanofiber (EPD-CNF) and PDMS. This EPD-CNF/PDMS composite exhibits strong piezoresistivity that translates into excellent sensitivity with an extremely high gauge factor of 23.1 , which is about 12-30 times higher than produced by graphene nanoribbon or carbon nanotube based nanocomposite sensors. The EPD-CNF/PDMS composite offers a low cost, high sensitivity sensor that can be manufactured and incorporated into the mouthguard 100. The composite remains intact under high mechanical strain, such as occurs during use, which may be attributed to the continuous and tangled electrospun nanofibers in the sensor. The strain sensor can be embedded in a side or bottom surface of the mouthguard 100 and communicatively coupled to the microprocessor 109 on the printed circuit board 103.
[0030] FIG. 2C illustrates an example of the fabrication of the composite sensor.
Initially, SU-8 nanofibers can be electrospun (A) on a silicon (Si) wafer and patterned (B) using photolithography. When deposited, the electrospun nanofibers form a continuous and randomly oriented layer that form a microscale spring. Carbonization (C) of the electrospun nanofibers enables the formation of stretchable conductive EPD-CNF within the embedding elastomers. The EPD-CNF can then be partially embedded (D) in PDMS and separated (E) from the Si wafer. Connectors can be assembled (F) on the EPD-CNF, which are then sealed (G) in PDMS as shown. FIG. 2D is a scanning electron microscope (SEM) image of carbonized nanofibers and FIG. 2E shows a cross-sectional view of the EPD-CNF embedded within the PDMS.
[0031] FIG. 2F shows the measured current-voltage (i-V) curves for strain sensors of FIG. 2B including EPD-CNFs that were carbonized at 900°C and 1000°C. The measuring setup is shown in inset of FIG. 2F. The extracted sheet resistances (Rs) of those carbonized nanofibers at 900°C and 1000°C were 830kQ/n and 50kQ/n, respectively, where Ω/π is ohms per square. FIG. 2G shows a measured gauge factor (GF = /e) of 23.1 with 50% strain at room temperature. The strain range can be further improved by optimizing the PDMS thickness.
[0032] Wireless Power Delivery. As shown in FIG. 1A, the mouthguard 100 can include a battery and charging circuit for wireless power delivery to the circuit board 103. Power can be delivered between a transmitter and a receiver located in the mouthguard 100 by inductive coupling between the antennas 809. The charging circuit can be part of a wireless power delivery system configured to supply power to the battery through inductive coupling. The delivered power may then be regulated by the charging circuit for delivery to loads on the circuit board 103 and/or sensors in the mouthguard 100. For example, BQ5001 10 and BQ51013 ICs from Texas Instruments Inc. may be used as the transmitter and the receiver, respectively, with near field power coupling provided through antennas. Since the
BQ500110 and BQ51013 ICs are highly integrated chips, nearly no peripherals are needed on the mouthguard 100 for power collection.
[0033] Long Distance Communication. The mouthguard 100 can be extended to support team applications. A software application deployed on a trainer's tablet (or other computing device) can communicate with and take measurements from a plurality of mouthguards 100 by pinging each individually to transfer their data to prevent channel crowding. The microcontroller 109 can transfer data to internal memory and/or external memory on the circuit board 103 during acquisition, and then transfer the stored information in response to the ping requesting transfer.
[0034] In the case of long distance transmission, the 434 MHz or 915 MHz ISM frequency bands can be used to implement a multi-layer system that includes an additional wireless module. The communication interface module 112 can either be located in the player's helmet or other equipment worn by the player, or integrated into the players clothing. Further, an external patch, which can be secured to the equipment and/or player, could be used for implementation of the communication interface module 112. The additional wireless module or communication interface 112 (external) can communicate using both 2.4 GHz (to mouthguard 100) and ISM bands (434 MHz or 915 MHz) as a virtual waypoint between the close range mouthguard 100 and externally located transceiver module located on the sideline or in coach's booth.
[0035] Referring to FIG. 3A, shown is an image of a prototype mouthguard 100 and a smartphone acting as the master device 1 12. The image shows example of an interface of the system application that is implemented on the smartphone. As shown in FIG. 3A, the interface allows a user to access the sensor information (e.g., accelerometer, gyroscope, magnetometer, temperature sensors, etc.). FIG. 3B illustrates an example of the sensor information that can be displayed on the master device. The information (e.g., biometric data) can be displayed in graphs through a user friendly mobile app for iOS or Android systems. The interface can also facilitate file transfer of the recorded sensor information from the mouthguard 100 to the master device 112 or to another externally located processing device, as described above. The interface can also allow the master device 112 to be disconnected from the mouthguard 100, allowing another device to connect as the master device.
[0036] The intelligent mouthguard 100 utilizes wearable electronics as part of a self- fitness monitoring system with wireless connectivity. Wearable electronics for fitness and wellness can help individuals monitor physical activity, diet, and sleep with continuous updates of biometric data. The mouthguard 100 can include a detection mechanism that can provide awareness of vital signs and potential sustained injury. The design and fabrication of the H3 (Head, Heat, and Heart- Related) mouthguard platform with 1 1 sensor channels and a friendly user interface has been presented. The device can be used in all sports or fitness activities where the user is interested in their biometric data from physical activity and their potential exposure to life threatening (head) injury. The H3 mouthguard platform is not limited to applications in sports fitness and wellness, but could find similar applications in the public safety (firefighter) and military sectors.
[0037] The concept can be further extended to a smart denture or retainer with a detection capability of diabetes, HIV, and cancer biomarkers from saliva and an integrated drug delivery functionality. In addition, as the mouthguard 100 is in good contact with saliva, which contains lots of biomarkers for health and disease monitoring and detection, the H3 mouthguard 100 can be extended to be used as a general health monitoring and intervention tool.
[0038] The H3 mouthguard 100 offers a multifunctional smart oral platform with real time biometric monitoring that includes potential danger detection and real time compliance report. The mouthguard 100 can be loaded with a plurality of sensor nodes, which track core body temperature, heart rate, blood pressure, impact parameters and/or other biometric indications. A temperature sensor 106b (FIG. 1 B) can be used to measure the body temperature inside the mouth, eliminating inaccuracies found in common external wearable devices that arise from the temperature gradient between the skin and environment. An infrared sensor 106c (FIG. 1 B) can be included to provide heart rate and blood pressure measurements using photoplethysmography (PPG), an optical technique that detects blood volume changes in microvascular tissues. Impact parameters can be tracked using a 9-axis inertial sensor 106a (FIG. 1 B) including a 3-axis accelerometer, 3-axis gyroscope, and 3-axis magnetometer. The 3-axis magnetometer uses the earth's magnetic field to allow the sensing algorithm to compensate for drift errors over longer periods of time thus providing a more accurate measurement of impacts from a lateral force and angular momentum. The H3 mouthguard 100 development includes electronics and firmware design, form factor integration, and software development. The device can provide accurate biometric analysis that can inform the user of their fitness level and exposure to risk of heat or impact related injuries. Functionalities include head impact detection (e.g., serious impact alerts and/or long term impact tracking), body temperature monitoring (e.g., potential injury alerts such as for heat stroke or dehydration), and vital sign tracking (e.g., personal fitness tracking).
[0039] It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations set forth for a clear
understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiment(s) without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.
[0040] It should be noted that ratios, concentrations, amounts, and other numerical data may be expressed herein in a range format. It is to be understood that such a range format is used for convenience and brevity, and thus, should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. To illustrate, a concentration range of "about 0.1 % to about 5%" should be interpreted to include not only the explicitly recited concentration of about 0.1 wt% to about 5 wt%, but also include individual concentrations (e.g., 1 %, 2%, 3%, and 4%) and the sub-ranges (e.g., 0.5%, 1 .1 %, 2.2%, 3.3%, and 4.4%) within the indicated range. The term "about" can include traditional rounding according to significant figures of numerical values. In addition, the phrase "about 'x' to 'y'" includes "about 'x' to about 'y"\

Claims

CLAIMS Therefore, at least the following is claimed:
1. An intelligent mouthguard system, comprising:
a mouthguard including:
a nine-axis inertial sensor comprising a three-axis magnetometer, a three-axis accelerometer and a three-axis gyroscope, the three-axis magnetometer configured to provide a reference plane in relation to the earth's magnetic field for the three-axis accelerometer and the three-axis gyroscope; and
an internal module in communication with the nine-axis inertial sensor, the internal module configured to provide sensor data corresponding to the three-axis magnetometer, the three-axis accelerometer and the three-axis gyroscope to an external processing unit when located in an oral cavity, the external processing unit communicatively coupled to the mouthguard.
2. The intelligent mouthguard system of claim 1 , wherein the external processing unit is a master device communicatively coupled to the mouthguard via a Bluetooth® link.
3. The intelligent mouthguard system of claim 2, wherein the master device is a
smartphone.
4. The intelligent mouthguard system of claim 2, wherein the master device is
configured to provide an indication of acceleration experienced by a wearer of the mouthguard through a user interface rendered on the master device.
5. The intelligent mouthguard system of claim 4, wherein the master device is
configured to adjust the acceleration based upon the reference plane provided by the three-axis magnetometer.
6. The intelligent mouthguard system of claim 1 , wherein the external processing unit is a communication interface module communicatively coupled to the mouthguard and communicatively coupled to a remotely located processing device.
7. The intelligent mouthguard system of claim 6, wherein the communication interface module is communicatively coupled to the mouthguard via a Bluetooth® link and communicatively coupled to the remotely located processing device via a WLAN link.
8. The intelligent mouthguard system of any of claims 1-7, wherein the internal module is configured to transmit the sensor data from the three-axis magnetometer, the three-axis accelerometer and the three-axis gyroscope to the external processing unit.
9. The intelligent mouthguard system of claim 8, wherein the sensor data is transmitted to the external processing unit in real-time.
10. The intelligent mouthguard system of claim 8, wherein the internal module transmits the sensor data to the external processing unit from memory in response to a transmission request received from the external processing unit.
11. The intelligent mouthguard system of any of claims 1-10, further comprising a
temperature sensor.
12. The intelligent mouthguard system of any of claims 1-11 , further comprising an
infrared (IR) sensor, wherein heart rate or blood pressure can be determined based upon sensor data from the IR sensor.
13. The intelligent mouthguard system of any of claims 1-12, further comprising a strain gauge sensor sealed in the mouthguard.
14. The intelligent mouthguard system of claim 13, wherein the strain gauge sensor comprises a polydimethylsiloxane (PDMS) and carbon nanofiber (CNF) composite sensing element.
15. The intelligent mouthguard system of claim 14, wherein the sensing element
comprises electrospun polymer derived conductive carbon nanofiber (EPD-CNF) sealed in polydimethylsiloxane (PDMS).
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