MONITORING

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Serial No. 63/115,956, filed November 19, 2020. The disclosure of the prior application is considered part of and is incorporated by reference in the disclosure of this application.

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

[0002] The present invention relates generally to intraoral devices and more specifically to an intraoral sensing device, system and method for detection, monitoring and/or analysis of physiological data.

BACKGROUND INFORMATION

[0003] It is a standard safety precaution in many athletic activities for participants to wear mouth guards. Ranging from baseball, to gymnastics, to martial arts, mouth guards are designed to protect the wearer from impacts that would otherwise cause injury to the mouth. Mouth guards are shaped to take the brunt of the impact and shield the teeth, gums, and tongue from trauma.

[0004] With the advent of sensorized wearable devices, such as wristbands, athletes and doctors have begun to explore the potential benefit of using wearables for collecting physiologic data. Due to the pre-existence of mouth guards within athletic use, various attempts have been made to integrate different sensors with standard mouth guards. Most prominently, certain companies are developing and promoting mouth guards having sensors to measure acceleration and impact to an athlete’s head to assess whether a concussion may have occurred. In certain sports, e.g., boxing, wrestling, football and mixed martial arts, mouth guards are a required protective device. However, in other sports, e.g., baseball, track and field, soccer and basketball, among others, the use of a mouth guard may be discretionary. Hence, the inclusion of a protective mouth guard as a foundation to support data collection intraorally is not a requirement. [0005] Data recorded from an athletic sensor, including a sensorized mouth guard, can be most useful if the data is available and actionable in real time. For example, a coach may rely upon data from a sensor to know if an athlete shows signs of being concussed, creating an opportunity for the athlete to be immediately removed from the game. Additionally, a coach might rely on data from one or more biometric sensors to know when to rotate out an athlete from play to reduce the risk of injury.

[0006] There exist many challenges associated with delivering data externally from a sensor deployed within an athlete’s body, including intraorally. For example, a wireless transmitter would likely need to rely on electrical power from a battery electronically coupled with the sensor. Typically, the level of power available would be very low. Hence, associated radio transmission signals would also be of the low-energy type. Consequently, attenuation of wireless signals transmitted from within an oral cavity would need to be addressed. Further, the wireless transmitter would need to be sufficiently robust to withstand the rigors of athletic activity. In certain instances, the wireless transmitter must be able to operate and withstand the same blunt-force impact against which a mouth guard is designed to protect, e.g., as in football.

[0007] Consequently, there remains a need for an intraoral sensing device, that is comfortable to the user, durable and that has wireless communication abilities to enable robust transmission of data to an exterior transmitter/receiver that is not placed on a user’s immediate body.

SUMMARY OF THE INVENTION

[0008] The present invention provides an intraoral sensing device, system and method for reliable and robust intraoral detection, monitoring and/or analysis of physiological data from a user of the device to allow for real-time decision making related to the user in a dynamic environment.

[0009] Accordingly, in one embodiment, the disclosure provides an intraoral sensing device that includes a frame, a polymeric shell encasing at least a portion of the frame, and a moldable component composed of a polymeric material that is detachably coupled to the frame and has a moldable bite surface that is configured to be molded to a bite profile of the user.

[00010] In another embodiment, the invention provides a system which includes the device of the invention in wireless communication with a remote computing device or cloud having functionality to receive, analyze, process and/or display data from the device.

[00011] In yet another embodiment, the invention provides a method for monitoring a physiological parameter of a subject using the intraoral device of the invention. The method includes inserting the device of the invention into the mouth of a subject, detecting data related to a physiological parameter of the subject via one or more sensors of the device, and wirelessly transmitting the data to a remote receiver, such as a cloud or remote computing device, thereby monitoring the physiological parameter of the subject.

BRIEF DESCRIPTION OF THE FIGURES

[00012] Figure 1 is an elevated perspective view of an intraoral sensing device in one embodiment of the invention.

[00013] Figure 2 is an elevated perspective view of a component of the intraoral sensing device depicted Figure 1.

[00014] Figure 3 is a front view of a component of the intraoral sensing device depicted in Figure 1.

[00015] Figure 4 is an elevated perspective view of a component of the intraoral sensing device depicted in Figure 1.

[00016] Figure 5 is a top view of the component shown in Figure 4.

[00017] Figure 6 shows various views of components of the intraoral device depicted in Figures 1-5.

DETAILED DESCRIPTION OF THE INVENTION

[00018] The present disclosure is based on an innovative intraoral sensing device, system and method for reliable and robust intraoral detection, processing and/or analysis of physiological data to determine a physiological state. The device and method allow for real-time decision making related to the user of the device in a dynamically changing environment, such as the playing of a sport.

[00019] Before the present compositions and methods are described, it is to be understood that this invention is not limited to particular devices, methods and experimental conditions described, as such devices, methods, and conditions may vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only in the appended claims.

[00020] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, references to “the device” include one or more devices, and references to “the method” include one or more methods, and/or steps of the type described herein which will become apparent to those persons skilled in the art upon reading this disclosure and so forth. [00021] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the invention, the preferred methods and materials are now described.

[00022] With reference to Figure 1, the invention provides an intraoral sensing device 10 that includes a frame 20 (not shown in Figure 1) encased by a polymeric shell 30 which encases at least a portion of the frame, and a moldable component 40 composed of a polymeric material.

[00023] The device is configured to provide a level of protection for a user’s teeth, tongue, and gums against impact-related injuries. In various aspects, the polymeric shell 30 is a semi-rigid, yet absorptive hollow enclosure capable of absorbing external forces and impacts via elastic deformation, thereby minimizing strain on the frame 20 which includes electronic circuitry.

[00024] Figure 2 shows the general shape and architecture of the frame 20. In various aspects, the frame 20 includes a first member 21 and a second member 22. In some aspects, the first member 21 and the second member 22 are connected by a hinge 23 that provides flexibility such that the frame 20 can easily conform to the shape of a user’s mouth for comfort in use, as well as absorption of impact forces to the device. In various aspects, the first member 21 includes a first flexible circuit board 24 and the second member 22 includes a second flexible circuit board 25 which may be electronically coupled across the hinge 23. [00025] A shown in Figure 2, the frame 20 has a generally arcuate shape having an outer surface 27 and an inner surface 28 that extend along a length such that the frame 20 is configured for placement between a lip and gum of the user with the outer surface 27 facing toward the lip and the inner surface 28 facing away from the lip when in use. In some aspects, the frame 20 is configured such that the hinge 23 is located in the middle of the length of the frame and is adjacent the superior labial frenulum of the user during use. In this configuration, the frame 20 is configured such that the first member 21 and the second member 22 are equally disposed on each side of the frame 20 with the hinge 23 being disposed adjacent the superior labial frenulum of the user during use.

[00026] The frame 20 further includes at least one sensor and at least one wireless communications module disposed on or in the first member 21 and/or the second member 22 of the frame for intraorally detecting a physiological parameter of a user and wireless transmitting data associated with the physiological parameter. The frame 20 also includes one or more batteries to power operation of the device. In the device having the frame 20 depicted in Figure 2, the battery 26 is disposed in the second member 22. However, it will be appreciated that the battery 26 may be disposed in the first member 21. Alternatively, the first member 21 and the second member 22 may both include batteries and the first flexible circuit board 24 and the second flexible circuit board 25 are not electronically coupled across the hinge 23, but rather each include their own battery source. As such, in some aspects, both the first member 21 and the second member 22 include a wireless communications module such that the first member 21 and second member 22 are in wireless communication with each other, and either or both of the wireless communications modules are also in wireless communication with a remote receiver.

[00027] In various aspects, the device further includes a module wireless communications module which includes an antenna. The module typically includes a Bluetooth® digital wireless protocol so that the device may communicate with a mobile computing device, another device of the present invention or a remote server or network, e.g., a cloud.

[00028] As used herein, a wireless communications module includes any structural and functional components known in the art to facilitate wireless communication with another computing device or remote network. The wireless communications module can include RF transceiver components such as an antenna and supporting circuitry to enable data communication over a wireless medium, e.g., using Wi-Fi (IEEE 802.11 family standards), Bluetooth® (a family of standards promulgated by Bluetooth SIG, Inc.), or other protocols for wireless data communication. In some embodiments, wireless communications module can implement a short- range sensor (e.g., Bluetooth®, BLTE or ultra-wide band). In some embodiments, wireless communications module can provide near-field communication (“NFC”) capability, e.g., implementing the ISO/IEC 18092 standards or the like; NFC can support wireless data exchange between devices over a very short range (e.g., 20 centimeters or less). Wireless communications module can be implemented using a combination of hardware (e.g., driver circuits, antennas, modulators/demodulators, encoders/decoders, and other analog and/or digital signal processing circuits) and software components. Multiple different wireless communication protocols and associated hardware can be incorporated into wireless communications module.

[00029] As discussed herein, the device further includes a polymeric shell encasing all or a portion of the frame. This provides an absorptive shell ensuring durability to the electronics contained in the frame, as well as protection and comfort to the user when the device is in use. Figure 1, shows an aspect of the device in which the polymeric shell 30 is disposed over substantially the entire frame.

[00030] Figure 3 is a front view of the polymeric shell 30 showing the outer surface that contacts the upper lip of a user when in use. As shown in Figure 3, the top surface of the polymeric shell 30 includes a notch 31 which is disposed over the hinge portion of the frame when the components of the device are assembled. The notch 31 is located in the mid-section of the length of the frame over the hinge and accommodates the superior labial frenulum of the user. In certain aspects, the polymeric shell 30 further includes one or more tabs 32 which are integral with slots of the moldable component 40 for assembly of the components of the device. The polymeric shell 30 further includes one or more reset ports 33 such that the circuitry of the frame may be accessed to reset the device.

[00031] With reference to Figure 1, the device 10 further includes a moldable component 40 composed of a moldable polymeric material which is detachably coupled to the frame and/or polymeric shell 30.

[00032] Figure 4 illustrates the moldable component 40 in one aspect of the device. With reference to Figure 4, the moldable component 40 includes a lip 41 that extends along the inner surface of the frame upon assembly of the components of the device. As discussed herein, in various aspects, the lip 41 is disposed between the frame and upper teeth and/or gum of the user upon assembly and use of the device to protect the teeth and/or gums of the user from the frame, as well as to protect the circuitry of the frame upon impacts during use of the device.

[00033] In some aspects, the moldable component 40 is attachable to the polymeric shell 30 to encase the frame 20. In the aspect of the moldable component 40 shown in Figure 4, slots 43 detachably engage with the tabs 32 of the polymeric shell 30 to encase the frame 20 upon assembly of the device.

[00034] The moldable component 40 further includes a moldable bite surface 42 that may be molded to the bite profile of a user. As such, in various aspects, the moldable component 40 is composed of a thermally moldable material, such as a thermally moldable polymer. Such polymers are commonly known in the art and used in convention mouth guards.

[00035] Figure 5 provides a top view of the moldable component 40 showing the moldable bite surface 42. In some aspects, the moldable component 40 includes a notch 44 in the lip 42 to allow for flexibility of the device, as well as comfort to the user during use.

[00036] In various aspects, the device of the invention includes one or more components configured to convey a state of the device and/or a physiological state of the user. In some aspects, the device includes one or more visual indicators, such as an LED which changes color, a given color being indicative of a given physiological state. For example, the LED may change to red to indicate danger that a biometric threshold has been crossed or is in danger of being crossed. In a similar manner, an LED may indicate a status of the device, such as a change to blue to indicate that a wireless connection has been made between the device and a remote receiver; or a change to red to indicate battery status. As such, the device includes one or more electronic components which include functionality to cause a visual indicator to be generated related to a given physiological parameter and/or status of the device.

[00037] In addition to visual indicators, or alternative to, the device may include a component configured to provide an audible indicator to convey a state of the device and/or a physiological state of the user. In some aspects, the device includes one or more sound generation components, such as a speaker which provides an audible indication of a given physiological state of the user. As such, the device includes one or more electronic components which include functionality to cause an audible alarm to be generated related to a given physiological parameter and/or status of the device.

[00038] In various aspects, the device may further include electronic circuitry for recharging the battery of the device. In one aspect, the device includes a recharging port configured to be coupled to a charging cord to recharge the battery of the device. In one aspect, the device includes a wireless charging circuit so that the battery may be charged wirelessly.

[00039] In some aspects, the frame is configured to automatically turn on and begin detecting a physiological parameter and transmitting data when contacted by saliva.

[00040] In some aspects, the device may further include a display strip detachably connected to the device for displaying a personalized message or brand, such as a logo or monogram. In some aspects, the display strip is attached to the polymeric shell and/or the moldable component.

[00041] In various aspects, the device is operable to detect, monitor and/or analyze physiological data of the user via one or more sensors and wirelessly transmit the physiological data to a remote receiver, such as a cloud and/or remote computing device, e.g., tablet or smart phone. For example, a sensor of the device may be utilized to detect breath rate, blood pressure, audio, pulse oximetry, EKG, EEG, galvanic data, ambient and/or body temperature, humidity, motion, e.g., accelerometer data, GPS/location, pressure, altitude, blood analytes, e.g., glucose, photoplethysmograph (“PPG”) waveform data and the like. By way of illustration, and in no way limiting, the device may include a cardiac monitor, a pulse oximeter, a photoplethysmogram, a capacitive sensor, an impedance sensor, a respiratory sensor, an audio sensor, a humidity sensor, a temperature sensor, a gyroscope, an accelerometer, an analyte sensor, or any combination thereof. [00042] As discussed herein, the invention further provides a method for monitoring a physiological parameter of a subject using the intraoral device of the invention. The method includes inserting the device of the invention into the mouth of a subject, detecting a physiological parameter of the subject via the one or more sensors of the device, and processing, analyzing and/or wirelessly transmitting physiological parameter data to a receiver, thereby monitoring the physiological parameter of the subject.

[00043] In various aspects, the physiological parameter is intended to include any detectable physiological parameter of the subject. In some aspects, a physiological parameter includes, but is not limited to heart rate, respiration rate, body temperature, oxygen consumption, oxygen saturation, hydration, saliva level, saliva enzyme(s), saliva chemical composition, a blood analyte and the like.

[00044] The one or more sensors of the device are provided to detect physiological and/or biometric data of the user. As such, the method may further include analyzing, with a processor, the physiological data. In various aspects, the processor may be integrated with the electronic circuity of the device or present in a remote computing device or server. As discussed, many different types of physiological data can be monitored and/or analyzed in various aspects of the invention. In various aspects, the physiological data includes blood pressure waveform data and/or PPG waveform data (such as that generated by a pulse oximeter).

[00045] In certain aspects, analyzing the physiological data includes analyzing the data against a pre-existing model. For example, the pre-existing model may include empirical data gathered from prior monitoring of an individual.

[00046] In some aspects, the method further includes assessing the hydration status or trend of an individual, and/or displaying (e.g., on a display device) an assessment of the hydration status or trend. Such an assessment can include, without limitation, an estimate of hydration status at a current time, a prediction at some point in the future, an estimate and/or prediction of a volume of fluid necessary for effective rehydration, an estimate of the probability an individual requires fluids, an estimate that an individual has consumed or may consume an excessive amount of fluid which might result in hyperhydration, an assessment of the level of fatigue of the individual, and, a recommendation for changing the work load or activity of an individual.

[00047] In various aspects, the device of the invention includes one or more sensors that detect data associated with the physiological aspects of bodily fluids, both extracellular fluids and intracellular fluids. An understanding of dehydration affords an ability to ensure that appropriate physiological parameters are used to assess hydration. In addition to describing the present invention, the following discussion provides a framework for understanding the mechanics of dehydration and other related physiological parameters, as they relate to the invention of the disclosure.

[00048] Dehydration refers to a deficit of total body water (TBW) with an accompanying disruption of metabolic processes. Early symptoms of dehydration may include a strong feeling of thirst, weakness, nausea, and loss of appetite. Severe symptoms may include confusion, muscle twitching, and bleeding in or around the brain.

[00049] Dehydration carries the risk of osmotic cerebral edema if rehydration is overtly rapid. Cerebral edema is excess accumulation of fluid in the intracellular or extracellular spaces of the brain. In various embodiments, the device includes a hydration sensor configured to provide sufficient monitoring to avoid overtly rapid hydration. For example, during a high school football game in a hot and humid environment, a player may actually consume excess water. The sensor will enable tracking in a manner that allows a recommended amount of fluid/ electrolyte to be consumed based on each player’s individual physiology, including exertion, size, gender, age, and height.

[00050] For routine activities, an individual’s level of thirst may serve as an adequate guide to maintain proper hydration. With exercise, exposure to hot environments, or a decreased thirst response, additional water may be required above and beyond what a person’s level of thirst may indicate. Consequently, there is a need for an intraoral hydration sensor capable of tracking relevant physiological parameters to determine an individual’s hydration trend and status, and, to provide accurate guidance for fluid intake and replenishment in real-time. [00051] Insensible water loss is defined as the amount of fluid lost on a daily basis from the lungs, skin, and respiratory tract, as well as water excreted in the feces. Insensible water loss is defined as loss that cannot be sensed. In contrast, sensible water loss is loss that can be sensed by an individual. Therefore, sensible water loss includes both urination and sweat. In assessing trends of hydration, algorithms associated with the hydration sensor or processing components for use with the invention consider aspects of both insensible and sensible water loss to provide a hydration assessment and suggest recommendations for therapeutic intervention, e.g., fluid replenishment, rest or activity reduction.

[00052] In various embodiments, the device includes one or more electronic components in communication with the one or more sensors, e.g., hydration sensor, which separately or collectively, include instructions for analysis of data applicable to an assessment of a person’s health status, such as hydration or cerebral status.

[00053] In another embodiment, the invention provides a system which includes the device of the invention in wireless communication with a remote computing device or cloud having functionality to receive, process, analyze and/or display data from the device. [00054] In various aspects, the device can communicate via a network. In aspects, the wireless communications module includes a Bluetooth® digital wireless protocol so that the device may communicate with a cloud and/or mobile computing device. Bluetooth® technology provides a low-cost communication link. The Bluetooth® transceiver may be configured to establish a wireless data link with a suitably equipped cloud, mobile computing device and/or another device of the invention. In some aspects, a device of the invention may operate in conjunction with another device of the invention.

[00055] As used herein, the term “mobile computing device” refers to any one or all of cellular telephones, tablet computers, phablet computers, personal data assistants (PDAs), palm-top computers, notebook computers, laptop computers, personal computers, wireless electronic mail receivers and cellular telephone receivers, multimedia Internet enabled cellular telephones, multimedia enabled smart phones (e.g., Android® and iPhone®), and similar electronic devices that include a programmable processor, memory, a communication transceiver, and a display. [00056] The device of the invention may also include functionality to communicate via a long-range wireless network which is a component of the system of the invention. In one aspect, the long-range wireless network includes a cellular network. In another aspect, the long-range wireless network includes a multimedia communications network. In another aspect, the long-range wireless network includes wireless technologies such as Global System for Mobile Communications (GSM), Code Division Multiple Access-One (cdmaOne), Time Division Multiple Access (TDMA), PDC, Japan Digital Cellular (JDC), Universal Mobile Telecommunications System (UMTS), Code Division Multiple Access- 2000 (cdma2000), and Digital Enhanced Cordless Telephony (DECT).

[00057] The device of the present invention may also include functionality to wirelessly communicate with a remote server or network. As such, in one aspect, the system of the invention includes a remote network, such as a cloud computing platform.

[00058] There will be three forms of data transmission to that cloud storage, with an automated process that determines the optimum communication channel to use based on the environment the device is in:

[00059] In some aspects, the system includes a cloud-based data storage environment between the device and a mobile computing device. The cloud may include functionality to both store and present back data, and may also be interrogated by an artificial intelligence engine to derive a range of predictive analytics that will learn from the continuous data flow from all devices activated in the system.

[00060] In some aspects, WiFi data is transmitted from the device in real-time to the cloud data storage environment and the mobile computing device presents data gleaned from the cloud data storage. In some aspects, in the absence of WiFi, using a cellular connection, data is transmitted from the device in real-time to the cloud data storage environment and the mobile computing device presents data gleaned from the cloud data storage. In some aspects, in the absence of WiFi and cellular, using a Bluetooth® connection, data is transmitted from the device in real-time to the mobile computing device for immediate data presentation of current data. Once connectivity from the mobile computing device via WiFi or cellular is available, data is transferred to a cloud data storage environment. In some aspects, in the absence of WiFi, cellular and Bluetooth®, data is stored onboard the device for extraction and uploaded via the mobile computing device, post-game once a WiFi or cellular connection is available.

[00061] Although the invention has been described with reference to the above examples, it will be understood that modifications and variations are encompassed within the spirit and scope of the invention. Accordingly, the invention is limited only by the following claims.