Fitness Monitoring and Tracking Devices
The mouthpiece with a photoelectric sensor inside the mouth stabilizes measurements by using elastomeric layers and minimizes ambient light interference, offering accurate fitness and performance tracking during contact sports.
Patent Information
- Application Number
- JP2022575219
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-06-05
- Filing Date
- 2021-05-28
- Publication Date
- 2025-10-28
- Estimated Expiration
- 2041-05-28
AI Technical Summary
Conventional fitness tracking devices, such as wrist-worn heart rate monitors and chest straps, are impractical and inaccurate during contact sports due to potential injury and sensor displacement, respectively, leading to unreliable physiological signal measurements.
A mouthpiece with a photoelectric sensor positioned inside the mouth, using elastomeric material layers to stabilize the sensor and minimize ambient light interference, integrated with a wireless communication module and power supply, allowing for real-time physiological data collection.
Provides accurate and stable heart rate and cardiopulmonary signal measurements during contact sports and extended periods, enhancing fitness and performance tracking without restricting movement.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to wearable fitness tracking and / or monitoring devices for use, for example, in sports and other activities, to monitor a user's fitness and other physiological indicators, such as heart rate (and / or other cardiopulmonary signals). [Background technology]
[0002] As is widely known, fitness tracking devices are used to monitor a user's fitness-related metrics and provide feedback regarding fitness and / or performance. Indeed, for example, it is desirable to monitor an athlete's fitness, fatigue, and effort during training or competition, providing important insights into performance and reducing the risk of injury.
[0003] For example, heart rate monitors are known for use in measuring heart rate (and / or other cardiopulmonary signals) for applications such as health monitoring, sports training, and fitness. Until recently, conventional devices capable of constantly monitoring a user's heart rate (and / or other cardiopulmonary signals) have been fairly cumbersome. For example, heart rate monitors often use electrocardiogram signals, requiring electrodes or straps to be worn around the chest.
[0004] A more convenient method for monitoring heart rate is pulse oximetry using a photoelectric sensor. Photoelectric sensors noninvasively measure the absorption of light through a user's tissue, such as a finger or earlobe, to determine the oxygen saturation of arterial blood and heart rate. The resulting signal is called a photoplethysmogram (PPG), and analysis of the PPG signal can determine the heart rate (and / or other cardiopulmonary signals) of the person to whom the PPG sensor is attached.
[0005] Traditionally, pulse oximetry requires the user to remain relatively still to obtain a good PPG signal. Using a PPG sensor on a moving person can result in inaccurate estimates of the user's heart rate (and / or other cardiopulmonary signals) due to sensor displacement, motion artifacts, or noise in the PPG signal.
[0006] U.S. Patent No. 10,456,053 describes a wrist-worn heart rate monitor that includes a PPG sensor and an inertial sensor, where the signal from the inertial sensor is used to identify and remove noise from the PPG signal. An initial heart rate value is selected from a number of heart rate candidates remaining in the resulting PPG spectrum and used to track the user's heart rate. The PPG spectrum is monitored while tracking the heart rate (and / or other cardiopulmonary signals) to determine whether the selected initial heart rate value is erroneous. The PPG spectrum is monitored, and the heart rate value is reset if necessary. Summary of the Invention [Problem to be solved by the invention]
[0007] This type of wrist-worn PPG sensor is becoming increasingly popular in fitness tracking watches and the like. However, watches or other wrist-worn devices are often impractical (or not permitted) when playing contact sports such as rugby due to the potential for injury to the wearer or other players. Furthermore, wrist-worn fitness trackers, even with software that removes noise from the monitoring signal, may not always be accurate enough for very effective fitness tracking, at least for some applications.
[0008] Performance tracking in professional sports is currently achieved through wearable devices such as GPS trackers and chest-worn heart rate monitors, and / or video analysis. However, such wearable devices are known to restrict movement, and they all measure what is happening to the athlete, not how the body is responding. Because all such wearable devices are placed within clothing or on the skin (e.g., chest straps), they move during use, leading to inaccurate sensor measurements.
[0009] It is therefore desirable to provide an accurate, user-wearable fitness and / or performance tracking device that is convenient and safe to wear during contact sports and / or over extended periods of time, and that provides accurate physiological signals that can be used to monitor a user's fitness, performance and / or health, and aspects of the present invention seek to solve at least one or more of these problems. [Means for solving the problem]
[0010] According to a first aspect of the present invention, there is provided a mouthpiece for a fitness tracking and / or monitoring system, the mouthpiece comprising a fixing member shaped and configured to be worn in the mouth of a user in use, the fixing member being formed from at least two layers of elastomeric material having a physiological sensor therebetween.
[0011] In a preferred embodiment, the sensor may be configured to generate a signal indicative of the user's heart rate (and / or other cardiopulmonary signals). The sensor may beneficially comprise a photoelectric sensor including a light source that, in use, shines light onto an area inside the user's mouth, and a sensor that receives reflected light from said area inside the user's mouth and generates an electrical signal indicative thereof.
[0012] At least one of the at least two layers of elastomeric material closest to the inside of the user's mouth may be substantially transparent in use. At least one of the two layers of elastomeric material furthest from the inside of the user's mouth may be substantially opaque in use. Thus, if the sensor is a photoelectric (PPG) sensor, the inner layer allows light to pass through to the user's skin and reflected light from the blood vessel(s) back to the sensor, while the outer layer prevents ambient light entering the user's mouth from interfering with the accuracy of the sensor.
[0013] The elastomeric material is advantageously an elastomeric polymer such as ethylene vinyl acetate (EVA). The sensor is advantageously positioned within said fixation member such that, in use, it is positioned adjacent to the roof of a user's mouth. The inventors have surprisingly found that PPG signals obtainable from the roof of a user's mouth are clearer and more stable than signals obtainable from other areas of the user's mouth.
[0014] The sensor may be advantageously incorporated into a substrate, the substrate further incorporating a control module, a power supply unit, and a memory module. The substrate (e.g., a printed circuit board or PCB) may further incorporate a wireless communication module and an antenna configured to wirelessly transmit data indicative of the signal generated by the sensor to a remote receiver. In this manner, physiological data generated by the sensor can be collected substantially in real time while the mouthpiece is worn.
[0015] In an exemplary embodiment, the sensor may be integrated into one end of the first elongated flexible connector. A second elongated flexible connector may be provided at (substantially perpendicular to) or integrally formed with the other end of the first elongated flexible connector, and the second elongated flexible connector may incorporate at least one of a control module, a power supply unit, a memory module, a wireless communication module, and a wireless communication antenna at one end. The first and second elongated flexible connectors may combine to form a substantially T-shaped flexible connector. Thus, in an exemplary embodiment, the PPG sensor may be located at the free end of a central "leg" of the T-shaped flexible connector (so as to be positioned adjacent the user's palate in use), and other sensors and electronics may be located at the free ends of the "arms" of the T-shaped flexible connector. Other sensors may include an accelerometer for measuring impact.
[0016] In some embodiments, the fixation member may be formed of at least three layers of elastomeric material, with the sensor disposed between a first layer and a second layer closest to the inner surface of the user's mouth in use, and a third layer formed on the second layer. The sensor may also advantageously comprise a photoelectric sensor, with the first and third layers being substantially transparent and the second layer being substantially opaque. The photoelectric sensor may also be provided on a flexible connector and positioned within the fixation member so that it is positioned adjacent to the roof of the user's mouth in use.
[0017] According to a second aspect of the present invention, there is provided a mouthpiece assembly comprising a mouthpiece substantially as described above and a storage case for storing the mouthpiece when not in use, wherein the mouthpiece comprises a receiving element of a wireless charging system and the storage case comprises a transmitting element of the wireless charging system, the transmitting element being located adjacent to the receiving element when the mouthpiece is located within the storage case.
[0018] The receiving element may comprise a conductive coil that is printed or otherwise disposed on a flexible printed circuit board located between the at least two layers of elastomeric material, and the transmitting element may comprise a plurality of overlapping conductive coils.
[0019] According to a third aspect of the present invention there is provided a fitness tracking and / or monitoring system comprising at least one mouthpiece substantially as described above, a receiver for receiving physiological data from a sensor in the at least one mouthpiece, and an analysis platform for analysing the physiological data and providing an output indicative of the or each user's fitness and / or performance.
[0020] According to a fourth aspect of the present invention, there is provided a method of manufacturing a mouthpiece for a fitness tracking and / or monitoring system, the method comprising: forming a true or matched mold of a user's teeth and gums; forming a first layer of elastomeric material over the mold; securing a physiological sensor circuit to the first layer of elastomeric material; and forming a second layer of elastomeric material over the physiological sensor circuit.
[0021] As before, the first layer may be substantially transparent and the second layer may be substantially opaque, and the sensor circuit may include a light source, a photoelectric sensor, and a wireless communication module for, in use, wirelessly transmitting data indicative of a signal generated by the sensor to a remote receiver.
[0022] These and other aspects of the present invention will become apparent from the following detailed description. [Brief explanation of the drawings]
[0023] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:
[0024] [Figure 1]FIG. 1 is a schematic diagram of a fitness tracking system according to an exemplary embodiment of the present invention. [Figure 2] FIG. 1 is a schematic diagram illustrating the main components of a PCB for a mouthpiece according to an exemplary embodiment of the present invention. [Figure 3] 1 is a schematic cross-sectional view of a mouthpiece according to an exemplary embodiment of the present invention. FIG. [Figure 4] FIG. 1 is an illustration of PPG sensor data obtained by a fitness tracking / monitoring system according to an exemplary embodiment of the present invention. [Figure 5] FIG. 10 is a plan view of a PCB for a mouthpiece according to an exemplary embodiment of the present invention. [Figure 6] 1 is a schematic perspective view of a mouthpiece and storage case of a fitness tracking / monitoring system according to an exemplary embodiment of the present invention. FIG. [Figure 7] FIG. 10 is a flow diagram illustrating the functionality of embedded firmware in a mouthpiece according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0025] 1 of the drawings, a performance monitoring system according to an exemplary embodiment of the present invention comprises one or more health tracking devices 10 communicatively connected (or connectable) to an edge device 12. The edge device 12 is communicatively connected to a cloud processing / storage facility 14, which processes and analyzes physiological data collected by the health tracking device(s), and outputs the performance tracking data to a dashboard 16 on a remote web-based analytics platform accessed, for example, via an associated app. A storage case 18 may be provided to store and (optionally) charge one or more health tracking devices when not in use.
[0026] Each health tracking device 10 consists of a printed circuit board (PCB) incorporating one or more sensors embedded in a mouthpiece, such as a sports mouthguard, gum shield, or orthodontic brace or fixed appliance used to mitigate or treat snoring or sleep apnea. Such mouthpieces may be generic or may be custom-fit to the user's mouth. The sensors on the PCB generate physiological signals acquired while the mouthpiece is worn and wirelessly transmit these signals (or representative data) to the edge device 12. The primary purpose of the edge device 12 is to receive data from the mouthpiece in use and store it locally and / or upload it to the cloud 14. Thus, it serves as a "gateway" between the mouthpiece 10 and the analysis platform. The user's mouthpiece data is processed and analyzed by the cloud (or local) computing platform 14, and a web-based dashboard 16 allows the user to view their data and analysis results in substantially real time on their personal computer, tablet, phone, or any web browser.
[0027] 2 of the drawings, the PCB embedded in the mouthpiece according to an exemplary embodiment of the present invention may consist of a microcontroller (MCU) 212 having a Bluetooth Low Energy (BLE) or other wireless communication, module 24, and a BLE (or other wireless communication technology) antenna 26. The PCB 20 also has a power supply unit (PSU) 28, an external flash memory module 30, LEDs 32, an inertial measurement unit (IMU) 34, a high impact accelerometer (HIA) 36, and a pulse oximeter (PPG) sensor 38. The PSU 28 is electrically connected to and provides energy to the MCU module 212, the IMU 34, the HIA 36, the PPG sensor 38, the LEDs 32, and the external flash memory module 30.
[0028] The IMU 34 may consist of a three-axis magnetometer, a three-axis accelerometer, and a three-axis gyroscope, which, together, can be used to generate data indicative of impacts to a player's head in terms of force, rotation, and direction. The HIA 36 can be used to detect much larger impacts than the IMU. The pulse oximeter and heart rate sensor 38 are used to obtain PPG, which represents changes in blood volume in the tissues of the user's microvascular bed. The PPG sensor 38 operates by shining a light source (from the LED 32) onto an area inside the user's mouth, such as the palate, and measuring the amplitude of green, red, and infrared light reflected back to the sensor in the ranges of 537 nm, 660 nm, and 88 nm, respectively. This allows for the collection of parameters not typically obtainable in real time during sport using prior art devices, as shown in the table below.
[0029] [Table 1]
[0030] Table 1. List of parameters / insights that may be gained from embodiments of the present invention
[0031] Referring to Figures 3 and 4 of the drawings, the mouthpiece is constructed from multiple thin layers of material. An outer protective layer 40 is substantially transparent (i.e., allows light to pass through). A middle layer 42 is black or very dark and substantially blocks light from passing through. An inner layer 44 (closest to the user's teeth and gums) is substantially transparent (i.e., allows light to pass through). A label 41 carrying information and / or a logo may be "sandwiched" between the outer layer 40 and the middle black layer 42. The PCB 20 containing the LED 32 and PPG sensor 38 is "sandwiched" between the black layer 42 and the inner transparent layer 44. Thus, any ambient light 46 entering the user's mouth is blocked by the black layer 42, thus preventing interference with the PPG sensor 38. Light from the LED 32 (between 10 nm and 3000 nm) is shone through the inner layer 44 onto the user's skin 48 and through the underlying mouth tissue 50 onto the blood vessel(s) 52, and the reflected light returns to the PPG sensor 38, where the amplitude of the reflected green 54, red 56 and infrared 58 light can be measured, an example of the data thus obtained is as shown in Figure 4 of the drawings.
[0032] The PSU 28 may be, for example, a 38 mAh lithium polymer battery, which may be charged, for example, by a wireless charging device using a resonating coil, with energy transfer occurring via magnetic induction between the coils.
[0033] Conventional mouthguards are formed by taking an impression of the teeth and gums and then applying multiple layers of heated and vacuum-formed ethylene vinyl acetate (EVA) resin onto the impression. The EVA layers are then trimmed and polished (between each layer) to achieve a smooth surface. Mouthguards or mouthpieces according to embodiments of the present invention can be manufactured as follows: In a first step, an impression mold of the user's teeth and gums is made using any known method. Next, a first transparent layer 44 of EVA is heated and vacuum-formed onto the mold, followed by trimming and polishing using known methods. Next, the PCB 20 is affixed to the first layer 44, and the PPG sensor 38 is positioned in the palate area beneath the "teeth." In this exemplary embodiment, the PPG signal is acquired from the user's palate, which the inventors have surprisingly found to provide sufficiently clear and stable results. However, the PCB 20 could theoretically be placed in the mouthpiece to obtain PPG signals from other parts of the user's mouth. Next, a black layer of EVA 42 is heat and vacuum formed over the first layer 44 and PCB 20, then trimmed and polished. If desired, a label / logo may be applied to the black layer 42. Finally, a third clear layer of EVA 40 is heat and vacuum formed over the black layer 42 and label / logo (if present), then trimmed and polished as in the previous step to complete the device.
[0034] In an alternative exemplary manufacturing method, the second and third layers 40, 42 can be formed by first heating the black EVA layer 42 to its melting point, then layering any label / logo thereon, and finally slowly laminating the third layer 40.
[0035] The PCB 20 may be configured to be "split" into three separate sections connected by a flexible connector, for example made of polyimide flexible PCB material. As shown in Figure 5 of the drawings, the PCB 20 is mounted around a substantially "T-shaped" flexible PCB 60, with the LEDs 32, external flash memory 30 and PSU 28 mounted on microchips at the end of one "arm" of the flexible PCB, the HIA, IMU and MCU modules mounted on microchips at the end of the other "arm" of the flexible PCB, and the PPG sensor mounted at the end of the central "leg" of the flexible PCB 60.
[0036] The PSU 28 may be charged wirelessly using two pairs of conductive coils. One of the conductive coils is integrated into the PCB 20 within the mouthpiece 10 and electrically connected to a lithium polymer battery, while the other is provided within (for example) the storage case and electrically connected to a power source (e.g., via a USB (or other) charging cable (not shown)). Referring to FIG. 6 of the drawings, the mouthpiece 10 is housed within a storage case 70 (made of, for example, plastic). A first coil 72 is provided within the mouthpiece 10 and may be printed on the PCB 20 using, for example, copper wire. To accommodate the unique shapes and configurations of custom-fit mouthpieces, the storage case 70 may have recesses that form a negative impression of the user's teeth and gums so that each mouthpiece 10 fits securely within the recesses of the storage case 70. The recesses may be coated with an antibacterial material, if necessary. However, the external configuration of the storage case 70 is generally typical, such as a rectangular box. Therefore, the transmitting element of the wireless charging device must be configured to fit various mouthpiece shapes. To address this issue, the transmitting element of the wireless charging arrangement consists of multiple overlapping coils 74 (to allow for misalignment of the mouthpiece), for example using copper wire, printed on a thin (slightly flexible) PCB 76. The case may be configured to "dock" to store and / or charge multiple individual storage cases or mouthpieces simultaneously.
[0037] The MCU 21 of the or each mouthpiece 10 is configured to execute embedded firmware to store data sampled from sensors (PPG, IMU, HIA) in an on-board flash memory module 30 and transmit the data to the edge device 12. Each mouthpiece (e.g., a sports mouthguard) has at least a "game" (or data collection) mode / state in which it samples and records data during use, and a "standby" mode / state that does nothing and is optimized for power saving. A flowchart of firmware configuration is shown as an example in Figure 7 of the drawings. The required operating mode may be determined by the user pressing a button (an 'on / off' button). Alternatively, changing between modes may occur upon moving the mouthpiece (or removing it from a charging station) after a period of inactivity (switching to "game" mode) or upon "docking" the mouthpiece for a predetermined period of inactivity and / or charging (switching to "standby" mode).
[0038] In an alternative exemplary embodiment, the PCB 20 may be mounted on or in a retainer, such as those commonly used for teeth whitening, straightening, or protection. Such a mouthpiece would be so thin that it would not significantly impede a user's breathing or speech and could be worn during any activity, contact or otherwise. In this case, the PCB would be sandwiched between two layers of material, such as EVA plastic, in a manner similar to that described above. Both layers may be transparent, although the outer layer could theoretically be made of a darker material if desired. In this way, the retainer could provide a more streamlined mouthguard while still providing the sensor functionality described above. In this case, the mouthguard, which fits snugly over the retainer and the user's teeth, could be worn over the retainer when the user participates in contact sports.
[0039] From the foregoing description, it will be apparent to those skilled in the art that modifications and variations can be made to the described embodiments without departing from the scope of the invention, as defined by the appended claims. In the above detailed description, specific reference is made to and described sports mouthguards. However, the present invention can be adapted to provide PPG measurement functionality to other types of mouth-worn devices, including dental or orthodontic retainer appliances used for a variety of purposes, and the invention is not intended to be necessarily limited in this respect.
Claims
1. 1. A mouthpiece for a fitness tracking and / or monitoring system, the mouthpiece comprising: a fastening member shaped and configured to be attached to a palate region of a user in use, the fastening member being formed from at least two layers of elastomeric material having a physiological sensor therebetween; the physiological sensor is mounted on an end of a central leg of a T-shaped printed circuit board; the physiological sensor is disposed within the fixation member such that, in use, it is positioned at the palate region of the user; the physiological sensor comprises a photoelectric sensor including a light source that, in use, shines light onto the palate region of the user, and a sensor that receives reflected light from the palate region and generates an electrical signal indicative of the user's heart rate and / or other cardiopulmonary signals; Mouthpiece.
2. at least one layer of the at least two layers of elastomeric material, the layer closest to the palate region of the user being substantially transparent; The mouthpiece according to claim 1 .
3. at least one of the two layers of elastomeric material, the layer furthest from the palate region of the user, being substantially opaque; The mouthpiece according to claim 1 .
4. The elastomeric material is an elastomeric polymer. The mouthpiece according to claim 1 .
5. the elastomeric polymer is ethylene vinyl acetate; The mouthpiece according to claim 4.
6. the physiological sensor is incorporated into a substrate; The board further includes a control module, a power supply unit, and a memory module. The mouthpiece according to claim 1 .
7. the substrate further incorporating a wireless communication module and antenna configured to wirelessly transmit data indicative of a signal generated by the physiological sensor to a remote receiver; The mouthpiece according to claim 6.
8. The T-shaped printed circuit board a first elongated flexible printed circuit board forming the central leg of the T-shaped printed circuit board and having the physiological sensor integrated at one end; a second elongated flexible printed circuit board provided at the other end of the first elongated flexible printed circuit board or integrally formed therewith; Preparation, the second elongated flexible printed circuit board has at least one of a control module, a power supply unit, a memory module, a wireless communication module, and a wireless communication antenna mounted on one end thereof; The mouthpiece according to claim 1 .
9. The T-shaped printed circuit board comprises a flexible printed circuit board, a plurality of the physiological sensors are disposed on the flexible printed circuit board between a first layer and a second layer of at least two layers of elastomeric material; The mouthpiece according to claim 1 .
10. the plurality of physiological sensors comprises or includes a heart rate monitor and an accelerometer; The mouthpiece according to claim 9.
11. the heart rate monitor comprises the photoelectric sensor; The mouthpiece according to claim 10.
12. the fixation member is formed of at least two layers of an elastomeric material, and the physiological sensor is disposed between the at least two layers. The mouthpiece according to claim 1 .
13. a removable mouthguard or gum shield device configured to fit over the retaining member and the user's teeth and gums in use. The mouthpiece according to claim 12.
14. the fixing member is formed of at least three layers of an elastomeric material, the physiological sensor is located between a first layer closest to the palate region of the user in use and a second layer, and the third layer is formed on a surface of the second layer opposite to a surface on which the first layer is in contact. The mouthpiece according to claim 1 .
15. the physiological sensor comprises a photoelectric sensor; the first and third layers are substantially transparent; the second layer is substantially opaque; The mouthpiece according to claim 14.
16. The photoelectric sensor is provided on a flexible printed circuit board. The mouthpiece according to claim 15.
17. The mouthpiece according to claim 1; a storage case for storing the mouthpiece when not in use, the mouthpiece comprises a receiving element of a wireless charging system; the housing includes a transmitting element of a wireless charging system; When the mouthpiece is located in the housing, the transmitting element is positioned next to the receiving element. Mouthpiece assembly.
18. the receiving element comprises a conductive coil printed or otherwise disposed on a flexible printed circuit board located between at least two layers of elastomeric material; the transmitting element comprises a plurality of overlapping conductive coils; 18. The mouthpiece assembly of claim 17.
19. At least one mouthpiece according to claim 1; a receiver for receiving physiological data from the at least one mouthpiece sensor; an analytics platform for analyzing the physiological data and providing an output indicative of the or each user's fitness and / or performance; Fitness tracking and / or monitoring systems.
20. 1. A method of manufacturing a mouthpiece for a fitness tracking and / or monitoring system, comprising: creating a true or matched mold of the user's teeth and gums, including the palate area; forming a first layer of elastomeric material on the mold or form; securing a physiological sensor circuit to the first layer of elastomeric material adjacent the palate region; forming a second layer of elastomeric material such that the physiological sensor circuit is sandwiched between the second layer and the first layer; the physiological sensor circuit is located at an end of a central leg of a T-shaped printed circuit board adjacent the palate region; the physiological sensor circuit comprises a photoelectric sensor including a light source that, in use, projects light onto the palatal region of the user, and a sensor that receives reflected light from the palatal region of the user and generates an electrical signal representative of the user's heart rate and / or other cardiopulmonary signals; A method for manufacturing a mouthpiece.
21. the first layer is configured to be positioned proximate the palate region of the user in use and is substantially transparent; the second layer is substantially opaque; the physiological sensor circuit comprising a wireless communication module for, in use, wirelessly transmitting data indicative of a signal generated by the sensor to a remote receiver; A method for manufacturing the mouthpiece according to claim 20.
22. the first layer is configured to be positioned proximate the palate region of the user in use; the first layer and the second layer are substantially transparent; the physiological sensor circuit comprising a wireless communication module for, in use, wirelessly transmitting data indicative of a signal generated by the sensor to a remote receiver; A method for manufacturing the mouthpiece according to claim 20.
23. forming a true or matched mold of the user's teeth and gums, including said mouthpiece; forming a mouthguard device on the mold or the mold; A method for manufacturing the mouthpiece according to claim 21 or 22.
24. forming a third substantially transparent layer of an elastomeric material over the second layer; A method for manufacturing the mouthpiece according to claim 21 or 22.
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