WO2022169779A1

WO2022169779A1 - Bruxism, sleep, and dental health monitoring platform

Info

Publication number: WO2022169779A1
Application number: PCT/US2022/014786
Authority: WO
Inventors: Rich Able; Joseph N. Kennelly Ullman; Christopher B. Harrison
Original assignee: Rich Able; Kennelly Ullman Joseph N; Harrison Christopher B
Priority date: 2021-02-02
Filing date: 2022-02-01
Publication date: 2022-08-11

Abstract

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. In some instances, a health monitoring device is provided in the form of a wearable mouthpiece having a plurality of sensors 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.

Description

BRUXISM, SLEEP, AND DENTAL HEALTH MONITORING PLATFORM

BACKGROUND

Technical Field

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.

Description of the Related Art

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.

BRIEF SUMMARY

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.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Figure l is a perspective view of one example embodiment of a health monitoring device in the form of a wearable mouthpiece.

Figure 2 is a top plan view of the health monitoring device of Figure 1 showing example locations of a plurality of sensor devices for capturing grinding and/or clenching data.

Figure 3 is a top plan view of a health monitoring device showing example locations of optional acoustic sensors.

Figure 4 is a top plan view of a health monitoring device showing example locations of optional temperature sensors.

Figure 5 is a diagram of a sensing module suitable for use in the health monitoring devices and systems disclosed herein.

Figure 6 is a system diagram of a health monitoring system, according to one example embodiment.

Figure 7 is a system diagram of a health monitoring system, according to another example embodiment. DETAILED DESCRIPTION

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.

Figure 1 shows one example embodiment of a wearable health monitoring device in the form of a mouthpiece to be worn by an individual. The mouthpiece includes a plurality of sensors (e.g., accelerometers, pressure transducers and/or strain gauges) positioned adjacent one another within portions of the mouthpiece that allow for secure fit and coverage of the user’s teeth. For example, the mouthpiece may include two or more strain gauges (or other sensors) in communication with electrical components for collecting bruxing event data during at least a portion of one or more bruxing events. The strain gauges may collect data related to forces generated during bruxing events over time in one or more targeted areas of the user’s dental arches.

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 Figure 2, the plurality of sensors (e.g., accelerometers, pressure transducers and/or strain gauges) may be placed in a pattern so as to capture acceleration and/or force data from all areas of the clenching zone - that is from a substantial entirety of the plan view of the user’s dental arches, including on both sides of the dental midline.

With reference to Figure 3, the mouthpiece may also contain one or more acoustic monitoring sensors to assess sleep apnea and related events such as momentary cessation of breathing and interrupted airflow during sleep. These acoustic monitoring sensors will deliver meaningful data for the dentist or other healthcare professional to determine the degree of severity and onset of this condition. The acoustic monitoring sensors may be communicatively coupled to local memory or external memory for selectively storing acoustic data for further processing and/or may be communicatively coupled to a wireless communication module for selectively transmitting acoustic data for further processing.

With reference to Figure 4, the mouthpiece may also contain one or more temperature sensors to collect temperature data of the user’s mouth. These temperature sensors may be used to assess patient health and/or to provide other functionality, such as detecting when the mouthpiece is in position for use. The temperature sensors may be communicatively coupled to local memory or external memory for selectively storing temperature data for further processing and/or may be communicatively coupled to a wireless communication module for selectively transmitting temperature data for further processing.

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 Figure 5, the health monitoring device may include a processor 240 and a memory 242 in communication with the processor 240. The memory 242 may include stored programming instructions operable by the processor 240 to allow the processor 240 to collect data from the plurality of bruxing data sensors 212 and optionally acoustic or other sensors 214 and to store such data in the memory 242. In some embodiments, one or more additional sensors, such as a proximity sensor 220, may be provided to determine when the health monitoring device is in place and worn by the user. The proximity sensor 220 or other such sensor is likewise in signal communication with the processor 240 and is preferably associated with the strain gauge or other bruxing data sensors 212 to confirm that the sensor data is valid because the health monitoring device (e.g., mouthpiece) is in use. A transceiver 244 is also provided in signal communication with the processor 240 for transmitting the bruxing data or other data to one or more external computing devices or networks. In addition, an onboard power supply (e.g., battery) is provided to supply power to the electronics. The power supply may be wirelessly chargeable through a base charging device or the like.

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 Figure 6, a wireless transmitter (such as 5G cellular) is provided allowing the data to be wirelessly transferred to a host computer, server or network that can store the sensor data. In some instances, the host computer may further include stored programming instructions allowing for the collection and evaluation of the sensor data. In some versions, the host computer may be configured to store the collected data over time, further calculating average data (such as average grind or most impactful event data at particular locations in the mouth), thereby allowing the computer to compare data for a particular day or time with a baseline average value.

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.

Figure 7 illustrates an exemplary system 100 that performs collection of bruxing information received from at least one health monitoring unit (HMU) 102 and makes the bruxing information available to relevant parties. The health monitoring unit 102 is a mouthpiece as described above that incorporates one or more sensors that are configured to collect impact and/or force data over time associated with grinding and/or clenching of teeth during at least a portion of one or more bruxing events. The system 100 includes a base unit 104 (e.g., charging base or communications base) that is in wireless communication with the health monitoring unit 102 and is optionally in wired or wireless communication with one or more devices 106. The health monitoring unit 102 may be directly coupled to the base unit 104, or may alternatively pass its data to the base unit 104 indirectly, through a server, network, or other electronic device. The base unit 104 includes a processor 112, a user interface 114, local memory 116, and a communication component 120. The base unit 104 may receive bruxing information wirelessly from the health monitoring unit 102 and optionally makes that data available to the one or more additional devices 106.

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 Figure 5. The proximity or position sensor can be configured to determine whether the mouthpiece is in place and being worn at the prescribed times for compliance measurement. In one example, the position sensor may be an optical or electrical resistance sensor to detect moisture (saliva) at the location of the sensor. The sensor is directed inward, to detect moisture (saliva) received on the mouthpiece. In such a case, the processor would conclude that the mouthpiece is being worn by the user. Other forms of sensors may also be used, such as temperature sensors (See Figure 4), piezoelectric sensors, capacitive sensors, magnetic sensors or other devices. In each case, the proximity or position sensor is in signal communication with the processor so that the memory can store data from the proximity or position sensor.

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.

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. 63/144,910, filed February 2, 2021 is incorporated herein by reference, in its entirety.

Claims

1. A health monitoring device, comprising: a mouthpiece; and a plurality of sensors carried by the mouthpiece and configured to collect impact and/or force data over time associated with grinding and/or clenching of teeth during at least a portion of one or more bruxing events.

2. The health monitoring device of claim 1, wherein the plurality of sensors are arranged to collect the impact and/or force data from one or more areas associated with a majority of an area of a plan view of the user’s dental arches, including opposing sides of the dental midline.

3. The health monitoring device of claim 1, wherein the plurality of sensors are arranged to collect the impact and/or force data from one or more areas associated with a substantial entirety of an area of a plan view of the user’s dental arches, including opposing sides of the dental midline.

4. The health monitoring device of claims 1-3, wherein the plurality of sensors include a plurality of strain gauges configured to measure forces over time associated with the grinding and/or clenching of teeth during the at least a portion of the one or more bruxing events.

5. The health monitoring device of claims 1-3, wherein the plurality of sensors include a plurality of accelerometers configured to measure acceleration data over time associated with the grinding and/or clenching of teeth during the at least a portion of the one or more bruxing events.

6. The health monitoring device of claims 1-5, further comprising a processor and a memory integrated into the mouthpiece, the processor being in signal communication with the plurality of sensors.

7. The health monitoring device of claim 1, wherein each of the plurality of sensors are located in the mouthpiece to collect data associated with accelerations and/or forces between teeth of an upper dental arch of a user and teeth of a lower dental arch of the user.

8. The health monitoring device of claim 1, wherein each of the plurality of sensors are selected or calibrated to detect accelerations and/or forces between teeth of an upper dental arch of a user and teeth of a lower dental arch of the user.

9. The health monitoring device of claims 1-8 wherein the device is configured to monitor and record and/or transmit a history of teeth grinding and/or clenching data over time, the history of teeth grinding and/or clenching data including magnitude and frequency data.

10. The health monitoring device of claims 1-9, further comprising an acoustic monitoring sensor to collect data associated with one or more acoustic events during a sleeping event in which the device is worn by a user.

11. The health monitoring device of claims 1-10, further comprising a proximity or position sensor that is configured to detect whether the mouthpiece is positioned within the mouth of a user.

12. The health monitoring device of claims 1-11, further comprising an optical sensor configured to monitor conditions related to tooth and gum condition.

13. A health monitoring system, comprising: a mouthpiece having a plurality of sensors that are configured to collect impact and/or force data over time associated with grinding and/or clenching of teeth during at least a portion of one or more bruxing events, and a power supply; and a charging device configured to selectively receive the mouthpiece and provide power to the power supply of the mouthpiece.

14. The health monitoring system of claim 13, wherein the charging device is provided in the form of a case that is configured to insertably receive the mouthpiece.

15. The health monitoring system of claim 13 or claim 14, wherein the charging device further includes a processor, a memory, and a communication device, the processor being in signal communication with the plurality of sensors of the mouthpiece via the communication device to receive and store the impact and/or force data over time associated with the grinding and/or clenching of teeth during the at least a portion of the one or more bruxing events.

16. The health monitoring system of claim 13 or claim 14, wherein the mouthpiece and the charging device are configured to monitor and record and/or transmit a history of teeth grinding and/or clenching data over time, the history of teeth grinding and/or clenching data including magnitude and frequency data.

17. A method, comprising: providing a mouthpiece having a plurality of sensors that are configured to collect impact and/or force data over time associated with grinding and/or clenching of teeth during at least a portion of one or more bruxing events; and collecting the impact and/or force data over time associated with the grinding and/or clenching of teeth during the at least a portion of the one or more bruxing events.

18. The method of claim 17, further comprising: transmitting the impact and/or force data over time associated with the grinding and/or clenching of teeth during the at least a portion of the one or more bruxing events to one or more computing devices for storage and/or processing.

19. The method of claim 17, further comprising: prior to collecting the impact and/or force data over time, detecting whether the mouthpiece is positioned within the mouth of a user.