This disclosure relates to a health monitoring device, platform and related methods for assessing, tracking, analyzing, diagnosing and/or treating bruxism, sleep disorders and/or other dental health conditions or disorders.
The nocturnal grinding of the teeth is a common condition for large segments of the population. This condition presents itself in pediatric dentistry patients and extends through senior care. There are two main types of bruxism: one occurs during sleep (nocturnal bruxism) and one during wakefulness (awake bruxism). Dental damage may be similar in both types, but the symptoms of sleep bruxism tend to be worse on waking and improve during the course of the day. The symptoms of awake bruxism may not be present at all on waking, and then worsen over the day. The causes of bruxism are not completely understood, but probably involve multiple factors. Awake bruxism is more common in women, whereas men and women are affected in equal proportions by sleep bruxism. Awake bruxism is thought to have different causes from sleep bruxism. Several treatments are in use, although there is little evidence of robust efficacy for any particular treatment.
Presently, there is no ability to assess, track, or analyze the impact of teeth grinding or nocturnal bruxism.
Embodiments of the present invention are directed to a bruxing monitoring device that includes an instrumented mouthpiece configured to be worn by an individual before they retire for the night and throughout their sleep cycle. The mouthpiece is configured to track impact and/or force data over time associated with one or more bruxing events (e.g., teeth grinding and/or clenching), thereby allowing a healthcare professional to monitor the severity and frequency of grinding and/or clenching over time. Further investigation by the healthcare professional may facilitate treatment of the cause of the symptom at an earlier time than might have been otherwise possible. Related systems and methods are also provided. Embodiments also include a monitoring device, platform and related methods for assessing, tracking, analyzing, diagnosing and/or treating other dental health conditions or disorders and/or sleep disorders, such as, for example, sleep apnea. In addition, it is appreciated that embodiments may be utilized by an individual throughout the day, including periods when the individual is not asleep.
In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with wearable health monitoring devices have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments.
Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
As discussed further below, the mouthpiece is created in a manner that allows the device to monitor the impact of the clenching and/or grinding of the upper and lower jaw and subsequent accelerations and/or forces over time exerted on the teeth during one or more bruxing events.
With reference to
With reference to
With reference to
The health monitoring device may include onboard components to collect, store, and transmit data from the various aforementioned sensors for evaluation later or in real time. For example, with reference to
It should be appreciated that while the aforementioned components (e.g., processor, memory) are described as being provided by a mouthpiece positioned in the mouth, in some embodiments, some components may be positioned in an accompanying device (e.g., charging base or case) that acts a charging station for the mouthpiece and optionally provides other functionality. For example, the accompanying device may include processors and other sensors such as acoustic sensors, light sensors, proximity sensors, temperature sensors, or other sensors. The accompanying device may be positioned near the user's sleeping area so as to collect data while the user sleeps, to assess the quality of the user's sleep. The accompanying device may collect and transmit data to other local computers (e.g., desktop computer, smartphone) or to computers or servers over a network, such as a wireless communications network.
In some embodiments, the health monitoring device is configured to allow data gathered by the health monitoring device to be transferred to a remote computer for subsequent evaluation. Thus, in one configuration as illustrated in
The host computer may likewise be in communication with a remote computer, directly or over a network such as the Internet. In some instances, the remote computer may be that of a dentist or other healthcare professional. The remote computer may be configured to evaluate the data in the same fashion as identified above, or may further include similar data aggregated from a multitude of patients in order to allow comparison of individual data or trends from a single user with aggregated data or trends from a larger population. The remote computer may also be a tablet or mobile phone.
In some embodiments, the charging case may be connected to a local computer that may collect and store the data similarly to the host computer described previously. The local computer may send the data to the host computer or other devices such as a mobile phone or tablet via Wi-Fi, Bluetooth, or similar wireless communication technology.
In yet other embodiments, the sensor data may be transmitted directly from the processor in the mouthpiece to a local device such as a computer, tablet, or mobile phone over Bluetooth, Wi-Fi, or similar.
In some instances, the charging case, local computer, remote computer, or all devices may include threshold values stored in memory and programming instructions that cause an alarm to be triggered if certain criteria are met.
In some versions, the base unit 104 or any of the devices 106 are in wired or wireless connection with a medical system 124 over a public or private data network 108. The medical system 124 receives bruxing and other information from the base unit 104 or the devices 106 for analysis with regard to stored patient information and/or storage into a database 126.
According to some embodiments, the health monitoring device may also include a proximity or position sensor, as previously discussed with reference to
In addition to determining compliance (that the user is properly wearing the mouthpiece) the proximity or position sensor, if configured to measure saliva, could be used to assess conditions related to dry mouth. The position sensor, especially if an optical sensor, may be able to monitor conditions related to tooth and gum health including plaque build-up and gingivitis. The same sensor may be able to detect the color of the teeth to monitor staining as it relates to the desire for tooth whitening.
The device 300 is designed to capture breathing and force measurement, among other characteristics of a user's activities during sleeping or waking hours. To that end, the device 300 includes a sensor array 304 including a plurality of sensors 304A-304D. In the example embodiment shown in
The sensors 304A-304D may be formed as flexible circuits, including but not limited to integrated circuits disposed on flexible substrates, to enable the body 302 to conform to the shape of the teeth of the user, including folding around the teeth, without damaging the sensors 304A-304D. The sensors 304A-304D may be any sensor of the type described herein. In a preferred embodiment, the sensors 304A-304D include sensors to detect and measure cardiorespiratory variables of the user, including but not limited to respiration sensors and audio sensors that detect respiration spectra (i.e., respiration intensity, duration, common breath sounds, type of breathing such as nasal or through the mouth) during waking and non-waking hours and also while the user is at rest or physically active, or both. Still further, the sensors 304A-304D may include one or more accelerometers to establish movement characteristics of the user during sleeping and waking hours.
The accelerometers may also assist with calibration of the device 300 by establishing baseline posture and relative axes of the posture of the user, including with respect to the jaw or head, neck, and spinal position and architecture of the user. In some embodiments, the calibration process may further include the use of disposable sensor stickers with one or more accelerometers. The stickers are temporarily attached to the body 302 for a calibration process and then can be removed before normal use of the device 300. Alternatively, the stickers may remain in place after calibration until disposal of the device 300. The accelerometers help the device 300 measure whether the user is standing up, laying down, laying on their side, or laying on their stomach as well as to measure the user's walking characteristics to establish gait dynamics. This data from the accelerometers can be interpreted in view of the other data collected by the sensor array 304 to determine how a user's movement characteristics impact bruxing events and respiration spectra, among other benefits.
The sensors 304A-304D may also include fiber optic sensors in a preferred embodiment. The fiber optic sensors measure airflow dynamics, such as air flow rate, volume, velocity, and other air flow characteristics. Still further, the sensors 304A-304D may include pulse oximeter sensors or pulp inflammation marks, or both, that measure the percentage of oxygen saturation and pulp inflammation to determine whether the user is experiencing sleep apnea or other sleep issues. Further, the sensors 304A-304D may include position sensors and moisture sensors to determine whether the user is wearing the device 300 and to measure the user's saliva to detect possible dry mouth issues, as described herein.
In some embodiments, the sensor array 304 further includes any of the hardware components described herein, such as the components described with respect to
The device 300 in
With continuing reference to
In operation, the user attaches the sensor array 404 to the body 402 with an acceptable fastening method and then attaches the body 402 to their teeth. The sensors 406 of the sensor array 404 then perform the functions described herein to provide information regarding various characteristics of the user during waking or sleeping hours, including movement characteristics, cardiorespiratory spectra (i.e., breathing intensity, duration, sounds, and type of breathing, among others), baseline posture and relative position of the user, airflow dynamics, oxygen saturation, pulp inflammation, whether the user is wearing the device, and other characteristics. The device 400 and the sensor array 404 may enable measurement of the above and other characteristics during a selected period of time, such as only during waking hours, only during sleeping hours, or during both sleeping and waking hours, along with a selected time period (i.e., between certain hours of the day or for a selected length of time in hours), with the length of time of use and the type of use (i.e., during sleeping or waking hours) recommended by a medical professional. The selected time period may also include periods of physical activity as well as a resting condition of the user.
It is to be appreciated that the bed 504 may include an embedded or onboard controller carried by the bed 504 or an external controller in communication with the bed 504 wherein the controller is configured to receive an input from the user and adjust the at least one characteristic of the bed in response to the input. The controller may include at least one memory for storing instructions and at least one processor for executing the instructions stored in the memory to adjust the at least one characteristic. Further, the bed 504 may include sensors in communication with the controller of the bed 504 for detecting sleeping parameters of the user and automatically adjusting the at least one characteristic accordingly.
As generally indicated in
In operation, the sensors of the mouthpiece 502 collect data of the type described herein during a selected period of time, which may be a non-waking or a sleeping period of the user while on the bed 504. The data collected by the sensors of the mouthpiece 502 may generally correspond to a number of different sleep quality characteristics. In other words, the data collected by the sensors on the mouthpiece 502 may indicate that the user is not experiencing quality sleep, or that certain issues, such as bruxing, can be improved by adjusting the at least one characteristic of the bed 504. In some non-limiting examples, the sensors on the mouthpiece 502 may detect that the user is experiencing a bruxing event and transmit a signal to the base unit 104 corresponding to the detected bruxing event. The base unit 104 may then determine an appropriate adjustment to characteristics of the bed 504 and transmit a signal or instructions to the bed 504 or the controller 504 of the bed 504 to adjust the at least one characteristic of the bed 504, such as elevation or the firmness of the bed 504, or both, accordingly. The determination of the appropriate adjustment to the bed 504 may be stored in the memory of the base unit 104 or in the memory of the controller of the bed 504 where the base unit 104 is omitted. The same process may be used if the mouthpiece 502 detects snoring or any other condition described herein.
In an embodiment, in addition to or in lieu of the bed 504, one or more pillows 506 may be provided that have one or more characteristics that are adjustable, such as a temperature, an amount of support, and a firmness of the pillow 506, among other characteristics. Thus, in addition to or in lieu of adjusting the at least one characteristic of the bed 504, the base unit 104 may transmit instructions to adjust the one or more characteristics of the one or more pillows 506. Each pillow 506 may have an embedded or onboard controller for receiving the instructions directly from the base unit 104 and adjusting the at least one characteristic of the pillow 506. In an embodiment wherein both a bed 504 and a pillow 506 are provided, the pillow 506 may be in direct communication with the bed 504 rather than the base unit 104 such that the instructions are communicated from the base unit 104 to the bed 504, and then from the bed 504 to the pillow 506. Such communication may occur wirelessly according to any known communication protocol and through the use of receivers, transmitters, or transceivers in the mouthpiece 502, the base unit 104, the bed 504, and/or the pillow 506. The base unit 104 may also have a wired connected to the pillow 506 in some embodiments.
In some embodiments, the adjustment of the at least one characteristic of the bed 504 and/or the pillow 506 is an iterative process. For example, if the mouthpiece 502 detects snoring, the mouthpiece 502 and the base unit 104 may instruct the bed 504 to adjust the elevation of the bed 504 or a firmness of the pillow 506, or both, for a selected period of time, such as one to five minutes or more or less. If the mouthpiece 502 continues to detect the condition after the selected period of time, the mouthpiece and the base unit 104 may instruct the bed 504 to further adjust the elevation or instruct the pillow 506 to further adjust the firmness, or any of the other characteristics of the bed 504 and/or the pillow 506 until the condition detected by the mouthpiece 502 is below a selected threshold value (i.e., a volume below a certain decibel level for snoring or a force impact below a certain selected force level for bruxing, etc.). In this way, the mouthpiece 502 may also be used in conjunction with the base unit 104, the bed 504, and/or the pillow 506 to improve the quality of the user's sleep and reduce the occurrence of certain sleep defects.
In at least one embodiment, the system 500 further stores data corresponding to the conditions detected by the mouthpiece 502 and the corresponding adjustments of the characteristics of the bed 504 and/or the pillow 506 as well as the impact of the adjustments of the bed 504 and/or pillow 506 to the conditions detected by the mouthpiece 502 over time. The base unit 104 may then transmit this information over any known protocol to a licensed medical professional for analysis. In one non-limiting example, if the mouthpiece 502 detects snoring and instructs the bed 504 and/or pillow 506 to adjust the at least one characteristic one or more times, as above, but the adjustments do not correct the snoring, then the licensed medical professional can view the data and suggest a treatment plan accordingly. Thus, the system 500 may further enable treatment of certain health issues that may occur during sleep, as detected by the mouthpiece 502.
Further embodiments of the disclosure may incorporate aspects described and shown at least with reference to
In at least some embodiments, the mouthpieces described herein are in communication with an IoT hub and/or with other IoT devices directly over one of the communication protocols described herein (such as is shown with devices 106 in
As described above, the mouthpiece may also enable communication with connected devices at a medical professional's office, as well as with a bed, pillow, and other aspects to provide the benefits and advantages herein. In yet further non-limiting examples, the mouthpiece may be in direct or indirect communication with an HVAC system to adjust a temperature of a room or space based on the information gathered by the sensors, such as to increase or decrease a temperature in a room if a user is having difficulty falling or staying asleep. The mouthpiece may also communicate with other medical devices of the user, such as a continuous positive airway pressure (CPAP) machine to adjust one or more operational characteristics of the machine based on the information gathered by the sensors on the mouthpiece. For example, if a user is having difficulty breathing, operation of the CPAP machine may be activated, or if already active, settings may be adjusted to improve the user's breathing. Many other configurations are possible and contemplated herein, even if not expressly mentioned. In summary, the mouthpieces and/or sensors carried by the mouthpieces may be in communication with any selected device now known or developed in the future that includes connectivity capability, such as IoT, WiFi, Bluetooth, Radio Frequency, and cellular communication enabled devices in some non-limiting examples.
It will be appreciated that computing systems and devices disclosed herein are merely illustrative and are not intended to limit the scope of embodiments of the present invention. The systems and/or devices may instead each include multiple interacting computing systems or devices, and may be connected to other devices that are not specifically illustrated, including via Bluetooth communication or other direct communication, through one or more networks such as the Internet, via the Web, or via one or more private networks (e.g., mobile communication networks, etc.). More generally, a device or other computing system may comprise any combination of hardware that may interact and perform the described types of functionality, optionally when programmed or otherwise configured with particular software instructions and/or data structures, including without limitation desktop or other computers (e.g., tablets, slates, etc.), database servers, network storage devices and other network devices, smart phones and other cell phones, consumer electronics, wearable devices, biometric monitoring devices, Internet appliances, and various other consumer products that include appropriate communication capabilities. In addition, the functionality provided by the systems disclosed herein may in some embodiments be distributed in various modules. Similarly, in some embodiments, some of the disclosed functionality may not be provided and/or other additional functionality may be available. In addition, in certain implementations various functionality of the system may be provided by third-party partners of an operator of the system. For example, data collected by the system may be provided to a third party for analysis and/or metric generation.
It will also be appreciated that, while various items are described as being stored in memory or on storage while being used, these items or portions of them may be transferred between memory and other storage devices for purposes of memory management and data integrity. Alternatively, in other embodiments some or all of the software modules and/or systems may execute in memory on another device and communicate with the illustrated computing systems via inter-computer communication. Thus, in some embodiments, some or all of the described techniques may be performed by hardware means that include one or more processors and/or memory and/or storage when configured by one or more software programs and/or data structures, such as by execution of software instructions of the one or more software programs and/or by storage of such software instructions and/or data structures. Furthermore, in some embodiments, some or all of the systems and/or modules may be implemented or provided in other manners, such as by consisting of one or more means that are implemented at least partially in firmware and/or hardware (e.g., rather than as a means implemented in whole or in part by software instructions that configure a particular CPU or other processor), including, but not limited to, one or more application-specific integrated circuits (ASICs), standard integrated circuits, controllers (e.g., by executing appropriate instructions, and including microcontrollers and/or embedded controllers), field-programmable gate arrays (FPGAs), complex programmable logic devices (CPLDs), etc. Some or all of the modules, systems and data structures may also be stored (e.g., as software instructions or structured data) on a non-transitory computer-readable storage mediums, such as a hard disk or flash drive or other non-volatile storage device, volatile or non-volatile memory (e.g., RAM or flash RAM), a network storage device, or a portable media article (e.g., a DVD disk, a CD disk, an optical disk, a flash memory device, etc.) to be read by an appropriate drive or via an appropriate connection. The systems, modules and data structures may also in some embodiments be transmitted via generated data signals (e.g., as part of a carrier wave or other analog or digital propagated signal) on a variety of computer-readable transmission mediums, including wireless-based and wired/cable-based mediums, and may take a variety of forms (e.g., as part of a single or multiplexed analog signal, or as multiple discrete digital packets or frames). Such computer program products may also take other forms in other embodiments. Accordingly, embodiments of the present disclosure may be practiced with other computer system configurations.
Moreover, aspects and features of the various embodiments described above can be combined to provide further embodiments. These and other changes can be made to the embodiments in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled.
U.S. Provisional Patent Application No. 63/246,491, filed Sep. 21, 2021 and U.S. Provisional Patent Application No. 63/313,197, filed Feb. 23, 2022 are incorporated herein by reference, in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/044266 | 9/21/2022 | WO |
Number | Date | Country | |
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63246491 | Sep 2021 | US | |
63313197 | Feb 2022 | US |