(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) 9) Word Inelletual Prope > eileen 07s eae Z AON 000 International Bureau = (20) International Publication Number (4s tnernational Publication Date = WO 2021/245384 AI 09 December 2021 (09.12.2021) WIPO|PCT (61) ineratnal Patent Clason: SA SC 80, SE, SG SK SL ST, SVSY, TH TH-TMLIN, ASIBSOOCIEUD) et 9024 2000) TRIE TZUAUGUSUZVOVNWS-ZA.ZM.2W aneinea em (84) Designated States (wiles otherwise indicated, for every (2) Internationa Applian Number Tina raion protection ae ARIPO BWC RCvGDAIRINSISIT — GMAXELR LSM. ZN RW. 8D, Se ST.S2-12 International Filing Date: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TI, ‘TMD, European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 28 May 2001 28052021) Fr. S, FL, FR, GB. GRR. HU, IE 1S, IT LT, LU, LV (25) Filing Language: English MC. MK, MT, NL, NO, PL, PT, RO, RS, SE SI. SK, SM. TR), OAPI (BF, Bl, CF, CG, Cl, CM, GA, GN, GQ. GW, (26) Publication Language: English EMC MMR. NE SN TD, TG). (60) Priority Data: 20084778 (05 June 2020 (15.06.2020) GB_ Published: (7) Applicant: ORB INNOVATIONS LID {GBiGay, 49 — Merton seach port 23) Philpot Street, London El 2511 (GB), Inventors: PATERSON, Robert; 49 Philpt iret, Lou- don Greater London E1 2511 (GB). QUINN, Thomas, 49 Phijpt Street, London Greater London E1 21H (GB), Agent: WHITE, Andrew: Matiys & Soute LLP. The Shand, 32 London Bridge Stet, London SE! 9SG (GB). Designated States /inkess othonsise indicated, for every ind of national protection available: AB, AG, AL, AM, AO, AT, AU, AZ,BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CHE, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO. DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GIl, GM, GT. HN, IR, HU, ID, IL, IN, IRIS, T, JO, J2 KE, KG, KH, KN, KP KR, KW, KZ, LA, LC, LK. LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, ) om a 021/245384 AL ll (64) Tite: FITNESS MONITORING AND TRACKING DEVICE Figure 1 (61) Abstract: A mouthpiece for fitness tracking and/or monitoring system, the mouthpiece comprising a retainer member shaped and configured to be wom, in se, witha user's mouth the retainer member being formed of at leas two layer of elastomeric material having a physiological sensor therebetween. a S 210 15 20 25 WO 2021/245384 PCTIGB2021/051317 FITNESS MONITORING AND TRACKING DEVICE Introduction This invention relates to a wearable fitness tracking and/or monitoring device for monitoring fitness and other physiological metrics, such as heart rate (and/or other cardio-respiratory signals) of a user, for use in, for example, sports and other activities, Background of the Invention Fitness tracking devices are well known and can be used to monitor a user's fitness- related metrics to provide feedback regarding their fitness and/or performance. Indeed, there is an ongoing desire to enable, for example, an athlete's fitness, fatigue and effort to be monitored during training and matches in order to provide key performance insights and reduce the risk of injury. For example, heart rate monitors are known for use in measuring heart rate (and/or other cardio-respiratory signals) for applications such as health monitoring, sports training and fitness. Conventional devices capable of constantly monitoring a user's heart rate (and/or other cardio-respiratory signals) have, until recently, been rather cumbersome. For example, heart rate monitors often use electrocardiogram (EKG) signals, which require electrodes or a strap placed around the user's chest. A less cumbersome technique for monitoring heart rate is based on pulse oximetry using a photoplethysmograph sensor. A photoplethysmograph sensor noninvasively measures the absorption of light passing through a user's tissue, e.g. a finger or ear lobe, to determine the oxygen saturation level of arterial blood and heart rate. The resulting signal is referred to as a photoplethysmograph (PPG), and the PPG signal can be analysed to determine, among other things, the heart rate (and/or other cardio-respiratory signals) of the person to which the PPG sensor is attached Conventionally, pulse oximetry has required the user to remain relatively motionless to ensure that a good PPG signal is obtained. When a PPG sensor is used with a person that is in motion, displacement of the sensor and motion artifacts or noise in10 15 20 25 30 WO 2021/245385 PCTIGB2021/081317 the PPG signal can result in inaccuracies in the estimated heart rate (andlor other cardio-respiratory signals) of the user. US Patent No. 10,456,053 describes a wrist worn heart rate monitor including a PPG sensor and an inertial sensor, wherein signals from the inertial sensor are used to identify and remove noise from the PPG signals. An initial heart rate value is selected from a number of heart rate candidates that remain in the resulting PPG spectrum and is used to track the heart rate of the user. The PPG spectrum is monitored while tracking the heart rate (andlor other cardio-respiratory signals) to determine if the selected initial heart rate value is in error. The PPG spectrum is monitored and the heart rate value reset as required ‘Wrist worn PPG sensors of this type are becoming increasingly prevalent within fitness tracking watches and the like. However, watches or other wrist-worn devices are often not practical (or permitted) when playing contact sports such as rugby, as they can cause injuries to the wearer or other players. Furthermore, wrist-worn fitness trackers may not necessarily be sufficiently accurate for highly effective fitness tracking, at least in some applications, even with software to remove noise from the monitoring signals. Performance tracking in professional sport is currently achieved with wearables such as GPS trackers and chest-worn heart-rate monitors, and/or video analysis However, such wearables are known to restrict movement, and they all measure what is happening to the athlete, rather than how their body is reacting, and all such wearables are located within clothing or on the skin (e.g, chest strap) which allows them to move around during use, leading to inaccurate sensor measurements Thus, it would be desirable to provide an accurate, user-worn fitness and/or performance tracking device, that is convenient and safe to wear during contact sports andlor over long periods of time, and which provides accurate physiological signals that can be used to monitor the users fitness, performance and/or health, and aspects of the present invention seek to address at least one or more of these issues Summary of the Invention10 15 20 25 30 WO 2021/245385 PCTIGB2021/081317 In accordance with a first aspect of the present invention, there is provided a mouthpiece for a fitness tracking and/or monitoring system, the mouthpiece comprising a retainer member shaped and configured to be worn, in use, within a user’s mouth, the retainer member being formed of at least two layers of elastomeric material having a physiological sensor therebetween In a preferred embodiment, the sensor may be configured to generate signals representative of the heart rate (and/or other cardio-respiratory signals) of a user. The sensor may, beneficially, comprise a photoplesythmograph sensor comprising a light source for, in use, shining a light on a region of the inside of a user's mouth and a sensor for receiving light reflected from said region of the inside of the user's mouth and generating electrical signals representative thereof. Atleast one of the at least two layers of elastomeric material nearest the inner surface of the user's mouth, when in use, may be substantially transparent. At least one of the two layers of elastomeric material furthest from the inner surface of the user's mouth, when in use, may be substantially opaque. Thus, if the sensor is a photoplethysmograph (PPG) sensor, the inner layer allows light to pass through to the user's skin and light reflected back from the blood vessel(s) to pass back to the sensor, and the outer layer prevents ambient light entering the user's mouth from interfering with the accuracy of the sensor. The elastomeric material is, beneficially, an elastomeric polymer such as Ethylene- Vinyl Acetate (EVA) The sensor is beneficially located within said retainer member such that, in use, itis located adjacent the user's palate. The inventors have, surprisingly, discovered that the PPG signal that can be obtained from the user's palate is clearer and more stable than that which could be obtained from other regions of the user's mouth The sensor may beneficially be incorporated on a substrate, said substrate further incorporating a control module, a power supply unit and a memory module. The substrate (e.g. printed circuit board or PCB) may further incorporate a wireless communication module and antenna configured to wirelessly transmit data representative of signals generated by said sensor to a remote receiver. Thus,10 1s 20 25 30 WO 2021/245385 PCTIGB2021/081317 physiological data generated by the sensor can be collected in substantially real time whilst the mouthpiece is being worn In an exemplary embodiment, the sensor may be incorporated at one end of a first elongate flexible connector. A second elongate flexible connector may be provided or integrally formed at the other end of the first elongate flexible connector (substantially at right angles thereto), said second elongate flexible connector having incorporated at one end thereof at least one or more of a control module, a power supply unit, a memory module, a wireless communication module and a wireless communication antenna, The first and second elongate flexible connectors, together, may form a substantially T-shaped flexible connector. Thus, in an exemplary embodiment, a PPG sensor can be located the free end of the central ‘leg’ of the T-shaped flexible connector (so that it is located adjacent the user's palate, in use), and other sensors and electronic components can be located at the free ends of the ‘arms’ of the T-shaped flexible connector. Other sensors may include an accelerometer for measuring impact. The retainer member may, in some embodiments, be formed of at least three layers of elastomeric material, with said sensor being located between first and second layers, nearest the inner surface of the user's mouth when in use, and a third layer formed over said second layer. Again, the sensor beneficially comprises a photoplethysmograph sensor, and said first and third layers are substantially transparent and said second layer is substantially opaque. Once again, the photoplethysmograph sensor may be provided on a flexible connector and located within the retainer member such that, in use, itis positioned adjacent the user's palate. In accordance with a second aspect of the invention, there is provided a mouthpiece assembly comprising a mouthpiece substantially as described above, and a storage case for receiving said mouthpiece, when not in use, the mouthpiece comprising a receiving element of a wireless charging system and said storage case comprising a transmitting element of a wireless charging system and, wherein said transmitting element is positioned adjacent said receiving element when the mouthpiece is, located within the storage case.10 15 20 Fry 30 WO 2021/245385 PCTIGB2021/081317 ‘The receiving element may comprise a conductive coil printed or otherwise provided on a flexible printed circuit board located between said at least two layers of elastomeric material, and said transmitting element may comprise a plurality of overlapping conductive coils, In accordance with 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 the sensor of said at least one mouthpiece and an analytics platform for analysing said physiological data and providing an output indicative of fitness and/or performance of the or each user. In accordance with 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 positive mould of or representative of a user's teeth and gum, forming a first layer of elastomeric material over said mould securing a physiological sensor circuit to said first layer of elastomeric material, and forming a second layer of elastomeric material over said physiological sensor circuit, As before, the first layer may be substantially transparent, said second layer may be substantially opaque, and said sensor circuit may comprise a light source, a photoplethysmograph sensor, and a wireless communications module for wirelessly transmitting data representative of signals generated by said sensor to a remote receiver, in use. These and other aspects of the invention will become apparent from the following detailed description Brief Description of the Drawings Embodiments of the present invention will now be described, by way of examples only, and with reference to the accompanying drawings, in which: Figure 1 is a schematic diagram of a fitness tracking system according to an exemplary embodiment of the present invention; Figure 2 is a schematic diagram illustrating principal components of a PCB for a mouthpiece according to an exemplary embodiment of the present invention;10 1s 20 5 30 WO 2021/245385 PCTIGB2021/081317 Figure 3 is a schematic cross-sectional view of a mouthpiece according to an exemplary embodiment of the invention; Figure 4 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 is a plan view of a PCB for a mouthpiece according to an exemplary embodiment of the present invention; Figure 6 is a schematic perspective view of a mouthpiece and storage case of a fitness trackinglmonitoring system according to an exemplary embodiment of the present invention; and Figure 7 is a flow diagram illustrating the functionality of embedded firmware in a mouthpiece according to an exemplary embodiment of the present invention. Detailed Description Referring to Figure 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 communicably coupled (or couplable) to an edge device 12. The edge device 12 is communicably coupled to a cloud processing/storage facility 14, which processes and analyses physiological data collected by the health tracking device(s) and outputs 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, for storing and (optionally) charging one or more health tracking devices, when not in use. ‘The or each health tracking device 10 comprises a printed circuit board (PCB), incorporating one or more sensors, embedded in a mouthpiece such as a sports mouthguard, gum shield, orthodontic appliance, such as those used to alleviate or treat snoring or sleep apnoeia, retainer, etc, Such mouthpieces may be generic or they may be custom fitted to the user's mouth. The sensor(s) on the PCB generate physiological signals obtained whilst the mouthpiece is wom and wirelessly transmit the signals (or data representative thereof) to the edge device 12, which is, essentially a receiver (or multiple receivers) configured to receive the data10 1s 20 23 WO 2021/245385 PCTIGB2021/081317 transmitted from the mouthpiece PCB. The primary purpose of the edge device 12 is to receive data from the mouthpiece, in use, and save the data locally and/or upload itto the cloud 14. Thus, it acts as a ‘gateway’ between the mouthpiece 10 and the analytics platform. The user’s mouthpiece data is processed and analysed by a cloud (or local) computing platform 14, and a web-based dashboard 16 allows users to view their data and analytics in substantially real time on a personal computer, tablet, phone or any web browser. Referring to Figure 2 of the drawings, a PCB embedded in a mouthpiece according to an exemplary embodiment of the present invention may comprise 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 carries a power supply unit (PSU) 28, an external flash memory module 30, an Led 32, an inertial measuring unit (IMU) 34, a high impact accelerometer (HIA) 36 and a pulse oximeter (PPG) sensor 38. The PSU 28 is electrically coupled, and supplies energy to, the MCU module 212, the IMU 34, the HIA 36, the PPG sensor 38, the LED 32 and the external flash memory module 30, The IMU 34 may comprise a 3-axis magnetometer, a 3-axis acoslerometer and a 3- axis gyroscope which, together in use, can be used to generate data representative of impacts on a player's head in terms of force, rotation and direction. The HIA 36 can be used to detect much greater impacts than the IMU. The pulse oximeter and heart rate sensor 38 is used to obtain a PPG which represents blood volume changes in the user's microvascular bed of tissue. The PPG sensor 38 works by shining a light source (from the LED 32) onto a region inside the user's mouth, e.g the palate, and measuring the amplitude of green, red and infrared light reflected back to the sensor to obtain the PPG, in the ranges of 537nm, 660nm and 88nm respectively. This allows for parameters to be collected that cannot typically be obtained in real time by prior art devices during sports, as set out in the table below,10 15 20 WO 2021/245385 PCTIGB2021/081317 AnaerobicThreshold Hydration Pulse Width Arterial stifiness Injury Risk Rate Force BloodPressure Lactate Threshold Reflection Index Collision Count Onset Amplitude Respiration Rate Collision Load Oxygen Saturation Speed Diastolic Amplitude Peak to Peak Stiffnessindex Dicrotic Notch Amplitude _| Player Load SystolicAmplitude Distance Power Ventilatory Threshold Glucose Pulse Area Work Rate Heart Rate Pulse interval Tae T- USE pose arava / Tigh Hat can GBaTved Tom emiboceNES OT Bre TWVENEON Referring to Figures 3 and 4 of the drawings, the mouthpiece comprises multiple thin layers of material. An outer, protective layer 40 is substantially transparent (ie. allows light to pass therethrough. A middle layer 42 is black or of a very dark colour that substantially prevents light from passing therethrough. An inner layer (closest to the user's teeth and gum) 44 is substantially transparent (i. allows light to pass therethrough). Labels 41 carrying information andlor logos may be ‘sandwiched between the outer layer 40 and the middle, black layer 42. The PCB 20, including the LED 32 and the 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 and thus prevented from interfering with the PPG sensor 38, Light (between 10nm and 3000nm) from the LED 32 shines through the inner layer 44 onto the user's skin 48 and through the underlying mouth tissue 50 to the blood vessels) 52, and the reflected light retums to the PPG sensor 38, where the amplitudes of the reflected green 54, red 56 and infrared 58 light can be measured, and an example of data thus obtained is illustrated in Figure 4 of the drawings. The PSU 28 comprises, for example, a 38mAh Lithium polymer battery which can be charged, for example, by a wireless charging arrangement using cooperative oscillating coils, with the transfer of eneray occurring by means of magnetic induction between the coils.10 15 20 23 30 WO 2021/245385 PCTIGB2021/081317 A conventional mouthguard is formed of mutiple layers of Ethylene-Vinyl Acetate (EVA) plastic, heated and vacuum formed, a layer at a time, over a positive mould of a user's teeth and gum. The layers of EVA are subsequently trimmed and polished (between formation of each layer) to achieve a smooth surface finish. A mouth guard or mouthpiece according to an embodiment of the invention may be manufactured as follows. In a first step, a positive mould of a user's teeth and gum is produced in any known manner. Next, a first, transparent layer 44 of EVA is heated and vacuum formed over the mould, and then trimmed and polished in a known manner. The PCB 20 is then stuck to the first layer 44, positioning the PPG sensor 38 under the ‘teeth’ onto the palate region. In this exemplary embodiment, the PPG signals are obtained from the user's palate, as it has surprisingly been discovered by the inventors to yield sufficiently clear and stable results. However, it will be appreciated that the PCB 20 could, in theory, be positioned in the mouthpiece such that PPG signals can be obtained from another part of the user's mouth, Next, a black layer 42 of EVA is heated and vacuum formed over the first layer 44 and PCB 20, and then trimmed and polished. Labels/logos may be stuck to the black layer 42 if required. Finally, a third, transparent layer 40 of EVA is heated and vacuum formed over the black layer 42 and labels/logos (if present), and then trimmed and polished, as before, to form the finished device In an alternative exemplary method of manufacture, the second and third layers 40, 42 may be formed by, first, heating the black EVA layer 42 to its melting point, then applying any labels/logos thereto, and then finally slowly applying the third layer 40. The PCB 20 may be configured to be ‘split into three separate sections, connected together by a flexible connector in the form of, for example, polyimide flexible PCB material. As shown in Figure 5 of the drawings, the PCB 20 can be configured around a substantially ‘T-shaped’ flexible PCB 60, with the LED 32, external flash memory 30 and PSU 28 provided on a microchip at the end of one ‘arm’ of the flexible PCB, the HIA, IMU and MCU modules provided on a microchip at the end of the other ‘arm’ of the flexible PCB, and the PPG sensor provided at the end of the central ‘leg’ of the flexible PCB 60, Charging of the PSU 28 may be achieved by means of wireless charging using two sets of conducting coils: one incorporated on the PCB 20 within the mouthpiece 1010 15 20 25 30 WO 2021/245385 PCTIGB2021/081317 and electrically connected to the Lithium polymer battery, and the other in a storage case (for example) and electrically connectable to a power source (e.g, by means of a USB (or other) charging cable (not shown). Referring to Figure 6 of the drawings, a (eg. plastic) storage case 70 houses a mouthpiece 10. A first coil 72 is provided within the mouthpiece 10, wherein the coil may be printed on the PCB 20 using copper traces, for example. In view of the unique shape and configuration of each custom fit mouthpiece, the storage case 70 may have a recess defining a negative mould of the user's teeth and gum, such thet the respective mouthpiece 10 fits securely within the recess in the storage case 70. The recess may be coated with an antibacterial material if required. However, the extemal configuration of the storage case 70 is likely to be generic, ¢.9, of rectangular box-like configuration Thus, the transmitting element of the wireless charging arrangement needs to be configured to cooperate with varying mouthpiece shapes. In order to address this issue, the transmitting element of the wireless charging arrangement comprises muttiple overlapping coils 74 (to allow for misalignment in mouthpiece positioning) printed on a thin (slightly flexible) PCB 76 using copper traces, for example. A case may be provided, that is configured to ‘dock’ multiple individual storage cases or mouthpieces for simultaneous storage andlor charging, ‘The MCU 21 of the or each mouthpiece 10 runs embedded firmware configured to sample the sensors (PPG, IMU, HIA), save the data to the onboard flash memory module 30 and send that data to the edge device 12. Each mouthpiece (e.g, sports mouthguard) have at least a “game” (or data collection) mode/state, for sampling and logging data during use, and an “idle” mode/state, where nothing is done and power saving is optimised. Referring to Figure 7 of the drawings, a flowchart of the firmware configuration is provided as an example only. Determination of the required mode of operation may be by means of a user pressing a button (‘on/off button). Alternatively, changing between modes may occur as a result of movement of the mouthpiece (or removal thereof from a charging station) after a period of inactivity (switch to “game” mode) or as a result of a predetermined period of inactivity andlor ‘docking’ the mouthpiece for charging (switch to “idle” mode) In an alternative exemplary embodiment, the PCB 20 may be mounted in or on a retainer, such as those commonly used for teeth whitening, teeth straightening or protection. The much thinner form factor of such mouthpieces means that the 010 1s WO 2021/245385 PCTIGB2021/081317 breathing and speech of a user is not significantly impaired, at they can be worn during any activity, whether contact sport or otherwise. The PCB could, in this case, be sandwiched between two layers of material, such as EVA plastic, in a similar manner to that described above. Both layers could be transparent, although the outer layer could, in theory, be formed of a darker material if desired. The retainer thus provides a more streamlined mouthguard, whilst stil providing the functionality of the sensor(s) as described above. In this case, a mouthguard which is, overmolded to fit over the retainer and the user's teeth can be worn over the retainer when the user participates in contact sports {twill be apparent to a person skilled in the art, from the foregoing description, 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, a sports mouthguard is specifically referenced and described. However, it wll be appreciated that the invention can be adapted to provide the PPG measurement capability in other types of mouth-worn devices, including dental or orthodontic retainers used for various purposes, and the present invention is not necessarily intended to be limited in this regard. u10 20 25 WO 2021/245385 PCTIGB2021/081317 CLAIMS 1. Amouthpiece for a fitness tracking and/or monitoring system, the mouthpiece comprising a retainer member shaped and configured to be worn, in use, within a user’s mouth, the retainer member being formed of at least two layers of elastomeric material having a physiological sensor therebetween 2. Amouthpiece according to claim 1, wherein said sensor is configured to generate signals representative of the heart rate (and/or other cardio-respiratory signals) of a user 3. Amouthpiece according to claim 2, wherein said sensor comprises a photoplesythmograph sensor comprising a light source for, in use, shining a light on a region of the inside of a user's mouth and a sensor for receiving light reflected from said region of the inside of the user’s mouth and generating electrical signals representative thereof 4. Amouthpiece according to any of the preceding claims, wherein at least one of the at least two layers of elastomeric material nearest the inner surface of the user’s mouth is substantially transparent. 5. Amouthpiece according to any of the preceding claims, wherein at least one of the two layers of elastomeric material furthest from the inner surface of the user's mouth is substantially opaque. 6. — Amouthpiece according to any of the preceding claims, wherein the elastomeric material is an elastomeric polymer. 7. Amouthpiece according to claim 6, wherein said elastomeric polymer is Ethylene-Vinyl Acetate. 8 Amouthpiece according to any of the preceding claims, wherein said sensor is located within said retainer member such that, in use, it is located adjacent the user's palate. 9. Amouthpiece according to any of the preceding claims, wherein said sensor is incorporated on a substrate, said substrate further incorporating a control module, a power supply unit and a memory module. 210 15 20 25 WO 2021/245385 PCTIGB2021/081317 10. Amouthpiece according to claim 9, wherein said substrate further incorporates a wireless communication module and antenna configured to wirelessly transmit data representative of signals generated by said sensor to a remote receiver 14. Amouthpiece according to any of the preceding claims, wherein said sensor is incorporated at one end of a first elongate flexible connector. 12, Amouthpiece according to claim 11, wherein a second elongate flexible connector is provided or integrally formed at the other end of the first elongate flexible connector, said second elongate flexible connector having incorporated at one end thereof at least one or more of a control module, a power supply unit, a memory module, a wireless communication module and a wireless communication antenna 13. Amouthpiece according to claim 11 or claim 12 wherein said first and second elongate flexible connectors, together, form a substantially T-shaped connector. 14, Amouthpiece according to any of the preceding claims, wherein multiple physiological sensors are provided on a flexible connector between said first and second layers of elastomeric material 15. Amouthpiece according to claim 14, wherein said multiple sensors comprise or include a heart rate monitor and an accelerometer. 16. Amouthpiece according to claim 15, wherein said heart rate monitor comprises a photoplethysmograph sensor. 17. Amouthpiece according to any of the preceding claims, wherein the retainer member is formed of at least two layers of elastomeric material, with said sensor being located between said at least two layers. 18. Amouthpiece according to claim 17, further comprising a removable mouthguard or gumshield device configured to fit over the retainer and a user's teeth and gum, in use. 19, Amouthpiece according to any of the preceding claims, wherein the retainer member is formed of at least three layers of elastomeric material, with said sensor B10 15 20 Fry WO 2021/245385 PCTIGB2021/081317 being located between first and second layers, nearest the inner surface of the user's mouth when in use, and a third layer formed over said second layer. 20. Amouthpiece according to claim 19, wherein said sensor comprises a photoplethysmograph sensor, said first and third layers are substantially transparent and said second layer is substantially opaque. 21. Amouthpiece according to claim 20, wherein said photoplethysmograph sensor is provided on a flexible connector and located within the retainer member such that, in use, itis positioned adjacent the user's palate. 22. Amouthpiece assembly comprising a mouthpiece according to any of the preceding claims, and a storage case for receiving said mouthpiece, when not in use, the mouthpiece comprising a receiving element of a wireless charging system and said storage case comprising a transmitting element of a wireless charging system and, wherein said transmitting element is positioned adjacent said receiving element when the mouthpiece is located within the storage case. 23. Amouthpiece assembly according to claim 22, wherein said receiving element comprises a conductive coil printed or otherwise provided on a flexible printed circuit board located between said at least two layers of elastomeric material, and said transmitting element comprises a plurality of overlapping conductive coils 24. Afitness tracking and/or monitoring system comprising at least one mouthpiece according to any of claims 1 to 21, a receiver for receiving physiological data from the sensor of said at least one mouthpiece and an analytics platform for analysing said physiological data and providing an output indicative of fitness andlor performance of the or each user. 25. _Amethod of manufacturing a mouthpiece for a fitness tracking and/or monitoring system, the method comprising forming a positive mould of or representative of a user's teeth and gum, forming a first layer of elastomeric material over said mould, securing a physiological sensor circuit to said first layer of elastomeric material, and forming a second layer of elastomeric material over said physiological sensor circuit “10 15 WO 2021/245384 PCTIGB2021/051317 26. Amethod of manufacturing a mouthpiece according to claim 25, wherein said first layer is substantially transparent, said second layer is substantially opaque, and said sensor circuit comprises a light source, a photoplethysmograph sensor, and a wireless communications module for wirelessly transmitting data representative of signals generated by said sensor to a remote receiver, in use. 27. Amethod of manufacturing a mouthpiece according to claim 26, wherein said first layer and second layers are substantially transparent, and said sensor circuit comprises a light source, a photoplethysmograph sensor, and a wireless communications module for wirelessly transmitting data representative of signals generated by said sensor to a remote receiver, in use. 28. Amethod of manufacturing a mouthpiece according to claim 27, further comprising the method comprising forming a positive mould of or representative of a user's teeth and gum including the mouthpiece, and forming a mouthguard device over said mould 28. Amethod of manufacturing a mouthpiece according to claim 27 or claim 28, further comprising forming a third, substantially transparent layer of elastomeric material over said second layer.WO 2021/245384 PCT/GB2021/081317 1/5 Figure 1 Cont SUBSTITUTE SHEET (RULE 26)WO 2021/245384 Figure 3 2/5 PCT/GB2021/081317 Blood Vessels Moat Tissue layer Tansparet I~44 20-—J ras unter senso ae? Bae (96806 ——— ————— Tye Tansaert { }~a9 41 Figure 4 gh ely ding GREEN GREEN Ugh Light Aeoeies SUBSTITUTE SHEET (RULE 26) sao Wat PPG/BYP OutputWO 2021/245384 PCT/GB2021/081317 3/5 Figure 5 Left Side Flexible Right Side Connector PPG strip SUBSTITUTE SHEET (RULE 26)WO 2021/245384 PCT/GB2021/081317 4/5 Figure 6 PERSONAL LASE CHARGING ASTIC CA 79 PLASTC CASE Vi SUBSTITUTE SHEET (RULE 26)WO 2021/245384 5/5 Figure 7 Idle Mode Keay ine 00 NO Yes ENTER IDLE MODE De-initialise al peripherals sample from sensors 6 Nathing PCTIGB2021/051317 Game mode Peripher! NO Save dat to flash memory ior bluetooth tx SUBSTITUTE SHEET (RULE 26) Other modes.INTERNATIONAL SEARCH REPORT ‘nrnatona ppiation No PCT/GB2021/051317 fv A188 60 "R685 020 ADD. A61B5/024 Aezocng to rntona Pater Cleeeaton (PC) ortoban nana claaoaton a PO B. IELOS SEARCHED Weimar dzounariatin eerahed (laa ficton eye lowed dat olan oy TOR) A618 ‘Doartatonsaahed ste ha insta GoamTarabon ihe ental sun Snir HeGD Wh ale ST Tecan aban Srauhed Gg te erator sarh are cata Dae and, whet rascal search a nee) EPO-Internal, WPI Data alga” Oto ot amen wnat, wine pppoe la Rebrte ia x Us 2018/310881 Al (YOON YONG KYU [US] ET 1-29 AL) 1 Novenber 2018 (2018-11-01) figures 1A-D, 2A-2C, 2£, 34-38 paragraph [0019] - paragraph [0032] x WO 2018/044959 Al (SMRT IP LLC [US]) 1-24 8 March 2018 (2018-03-08) figures 1-10, 15-16,31-32 paragraph [0105] - paragraph [0131] x US 10 517 525 B2 (UNIV FLORIDA [US)) 1-24 31 December 2019 (2019-12-31) Figures 1,3,4A-B,64-D,10 colum 2, line 39 - column 3, line 20 colum 4, line 7 - line 27 colum 4, line 35 - line 59 colum 5, line 8 - colum 6, line 31 X] Further documents are listed in the continuation of Box ©. LX] See patent family annex. ee “Tl inure pid at nan tng ite of provy “A damn dtoing te general sate the a wh i natconateres ean notin cote wih he pletion bi oe funder dnumetdfring ie gener the pnope cary undeing te vention “E* eater agpesion pte but pubes on rater th intestinal “ng “L eccumet wich may how deus on port clans) er wich ‘ied gesablen te pusaten dale ot aneher oaton ether ‘Spe reasen os specie) “0° cecum tering fan alse, a nein oor “Feed tot erat ig atte an "% doumntt prt rears te eltradventon cama be ‘Sones fave orennnabe enagredio mre ar mene ep wren he doumet stake eneiered invoke an rvorve sep when te douner e Sonedwin ne sro ser sus acumen oy soinaon Being ovum peaon ed ibe a "a" duet member of te eame patent ty Dat he ada compton ce remand e| Date malig of ie Wearatorl search epar 25 August 2021 0209/2021 Tare anaing as oe SAT andr eset st Pond Foot 70 oa018 Knoop, Jan Fam POTION pea PoE) page 1 of 2INTERNATIONAL SEARCH REPORT ‘nrnatona ppiation No PcT/6B2021/051317 “Sanmatony DOCUNENTS CONSTOEFED TOBE RELEVANT ater” | Ctton ot coum whindeton er sepoprs, the lant peacges evento on, x EP 3 598 934 Al (SEIKO INSTR INC [JP]; 1-29 UNIV SHOWA [JP]) 29 January 2020 (2020-01-29) figures 1-4,6A-B, 8-9 paragraph [0012] - paragraph [0021] A US 2012/172677 Al (LOGAN ROBERT J [US] ET 1-13, AL) 5 duly 2012 (2012-07-05) 22,23 figures 2, 11 paragraph’ [0045] Fam POTION estonia BT OH page 2 of 2INTERNATIONAL SEARCH REPORT Invormation on patent amily members International appeation Ho PCT/GB2021/051317 Peter dooument itedin search report Pableaton ate Paton famly ‘membera) Pablcation ate US 2018310881 AL WO 2018044959 AL US 10517525 B2 EP 3598934 AL US 2012172677 AL 01-11-2018 08-03-2018 31-12-2019 29-01-2020 05-07-2012 US wo NONE Us wo CN EP J US AU cA EP J US Us US US Wo 2018310881 AL 2017070343 AL 2015305671 AL 2014110548 AL 110755053 A 3598934 AL 2020014769 A 2020029821 Al 2011351985 AL 2822957 AL 2658436 AZ 2014504517 A 2012172677 AL 2012172678 AL 2012172679 AL 2015306486 AL 2012092524 A2 61-11-2018 27-04-2017 29-10-2015 17-07-2014 07-02-2020 29-01-2020 30-01-2020 30-01-2020 11-07-2013 05-07-2012 06-11-2013 24-02-2014 05-07-2012 05-07-2012 05-07-2012 29-10-2015 05-07-2012