System and method for diagnosing or treating bruxism

Abstract

A system for diagnosing or treating bruxism. The system includes a wearable device configured to be coupled to a head of a patient to move as the patient expresses bruxism. The wearable device includes an energy harvester configured to detect muscle movement and generate electrical signals in response to the detected muscle movement and a signal processor configured to process the electrical signals from the energy harvester to provide processes electrical signals indicative of bruxism.

Description

SYSTEM AND METHOD FOR DIAGNOSING OR TREATING BRUXISMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is based on and claims the benefit of U.S. Provisional Patent Application 63 / 598,871, filed on November 14, 2023, and entitled “Wearable Self-Powered Device for and Method of Diagnosing and / or Treating Bruxism”. The entire contents of which is hereby incorporated by reference, for any and all purposes.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] N / ABACKGROUND

[0003] The present disclosure relates generally to systems and methods for the diagnosis and / or treatment of bruxism and, more specifically, to systems and methods using sensors and mechatronic apparatuses for the detection and treatment of teeth grinding caused by bruxism.

[0004] Bruxism is disorder characterized by intensive involuntary, unconscious, and / or excessive teeth grinding, which can occur during sleep or at other times. Severe or chronic bruxism can lead to various dental and health problems, including dental damage, jaw pain, and dysfunction. In 2021, national dental care expenditures amounted to $162 billion, up 11% from 2020. It is noteworthy that a proportion of these expenses can be attributed to the repercussions of bruxism, encompassing recurrent dental consultations, protracted therapeutic interventions, and the procurement of related medical devices.

[0005] Given the escalating societal stressors emanating from the rapid tempo of contemporary lifestyles, there exists an imperative demand for the development of efficacious interventions to address the issue of bruxism. Current popular treatment methods such as occlusal splints and botulinum toxin type A (BTX-A) have their limitations, including high cost, frequent clinical visits, and potential unknown side effects resulting from injection. Most medical devices for treating bruxism are associated with power supplies and bulky shapes that are not compatible with a user’s daily life.

[0006] Thus, there is a continuing and increasing need to provide systems and methods to reduce the onset of bruxism and / or to stop or control the issues arising from bruxism, preferably withoutcreating new complexities that interfere with the patient’s life and / or inducing new conditions as a side effect of therapies or treatments.SUMMARY

[0007] The present disclosure overcomes the aforementioned drawbacks by providing systems and methods for detecting bruxism and / or providing biofeedback to assist individuals in mitigating their bruxism behavior. Instead of passively inhibiting muscle activity or administering drugs, the systems and methods provided herein are designed to selectively intervene jaw muscle movement in real-time during bruxism episodes, helping patients develop a heightened awareness and facilitating the cessation of bruxism through the guidance of biofeedback mechanisms.

[0008] In accordance with one aspect of the disclosure, a system is provided for diagnosing or treating bruxism that includes a wearable device configured to be coupled to a head of a patient to move as the patient expresses bruxism. The wearable device includes an energy harvester configured to detect muscle movement and generate electrical signals in response to the detected muscle movement and a signal processor configured to process the electrical signals from the energy harvester to provide processes electrical signals indicative of bruxism.

[0009] In accordance with another aspect of the disclosure, a method is provided for diagnosing or treating bruxism. The method includes detecting muscle movement using a sensor positioned on a head of a patient, processing signals acquired from the sensor to identify processed signals indicative of bruxism, and delivering biofeedback to the patient when the processed signals are indicative of bruxism to alert the patient of a bruxism event or to discontinue activities inducing the muscle movement.

[0010] In accordance with yet another aspect of the disclosure, a piezoelectric energy harvester is provided for use in a bruxism diagnosis or treatment system. The harvester includes a flexible substrate, a plurality of piezoelectric layers stacked on the flexible substrate. Each piezoelectric layer is configured to generate electrical signals in response to deformation caused by muscle movement. The harvester also includes an adhesive layer configured to attach the piezoelectric energy harvester to facial skin of a patient to position the plurality of piezoelectric layers to detect temporalis or masseter movement of the patient.

[0011] The foregoing and other aspects and advantages of the present disclosure will appear from the following description. In the description, reference is made to the accompanying drawings thatform a part hereof, and in which there is shown by way of illustration one or more embodiment. These embodiments do not necessarily represent the full scope of the invention, however, and reference is therefore made to the claims and herein for interpreting the scope of the invention. Like reference numerals will be used to refer to like parts from Figure to Figure in the following description.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Various objects, features, and advantages of the disclosed subject matter can be more fully appreciated with reference to the following detailed description of the disclosed subject matter when considered in connection with the following drawings, in which like reference numerals identify like elements.

[0013] Fig. l is a schematic illustration of a system in accordance with the present disclosure.

[0014] Fig. 2A is a schematic illustration of an energy harvester in accordance with the present disclosure.

[0015] Fig. 2B is a schematic illustration of a multi-layer energy harvester in accordance with the present disclosure.

[0016] Fig. 3 is a schematic illustration of a feedback system in accordance with the present disclosure.

[0017] Fig. 4 is a set of graphs showing that monitoring using the systems and methods described herein can distinguish different activities.

[0018] Fig. 5 is a non-limiting example filter circuit in accordance with the present disclosure.

[0019] Fig. 6 is a non-limiting example circuit for a passive signal processor in accordance with the present disclosure.

[0020] Fig. 7 is a non-limiting example circuit for a power management unit (PMU) in accordance with the present disclosure.

[0021] Fig. 8 is a graph showing voltage rise over time resulting from monitoring in accordance with the present disclosure.

[0022] Fig. 9 is a flowchart showing some non-limiting example steps of a process in accordance with the present disclosure.

[0023] Fig. 10 is a set of box plots produced from some non-limiting testing of the systems and methods of the present disclosure.DESCRIPTION

[0024] As will be described, the present disclosure provides systems and methods for detecting bruxism and / or providing biofeedback to assist individuals in mitigating their bruxism behavior. Referring to Fig. 1, one non-limiting example of a system 100 in accordance with the present disclosure is provided. The system 100 may include a wearable device 102 that may include an energy harvester 104, a signal processor 106, and a feedback device 108. As will be described, the energy harvester may include a piezoelectric energy harvester pad that generates energy from the movement of the patient 109 when wearing the wearable device 102. That is, as illustrated the wearable device 102 may be positioned along a jawline of the patient 109, with the processor 106 and feedback device 108 positioned strategically and discretely behind the energy harvester 104. In this way, the energy harvester 104 may be arranged to detect or respond to masseter movement. Additionally or alternatively, the energy harvester 104 may be configured to detect or respond to temporalis movement, as illustrated by 104a. As will be described, not only does the energy harvester generate energy to power the wearable device 102, but the energy harvester can also function as a sensor that effectively detects actions by the patient 109 that are indicative of bruxism, symptoms of bruxism, and / or conditions associated with the treatment of bruxism. In some configurations, the processor 106 may simply serve as a filter to filter such signals from the energy harvester 104 when operating as a sensor to then provide filtered signals to the feedback device 108 to deliver therapies correlated to the conditions indicated by the filtered signals. In other configurations, the signal processor 106 may include a variety of components, for example, in addition to or instead of filtering. For example, the signal processor 106 may include a computer processor to perform sophisticated signal processing, to control the operation of the energy harvester 104 and / or the feedback device 108, and / or perform other functions. In one non-limiting example, the signal processor 106 may include communication capabilities to communicate with, for example, a computing system 110.

[0025] The computing system 110 can take any of a variety of forms, including a computer, including a laptop, or may be a phone, tablet, watch, or other device, including a wearable. The computing system 110 can include a processor or controller 112, a display 114, one or more inputs 116, one or more communication systems 118, and / or memory 120. In some configurations, the controller 112 can be any suitable hardware processor or combination of processors, such as a central processing unit (“CPU”), a graphics processing unit (“GPU”), and so on. In someconfigurations, the display 114 can include any suitable display devices, such as a liquid crystal display (“LCD”) screen, a light-emitting diode (“LED”) display, an organic LED (“OLED”) display, an electrophoretic display (e.g., an “e-ink” display), a computer monitor, a touchscreen, a television, a screen of a mobile device, such as a phone or tablet, and so on. In some configurations, the inputs 116 can include any suitable input devices and / or sensors that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, and so on.

[0026] In some configurations, the communications systems 118 can include any suitable hardware, firmware, and / or software for communicating information. In this regard, as illustrated, the communications system 118 can connect directly to the wearable device 102. Additionally or alternatively, the computing system 110 and / or the wearable device 102 can communicate over a communication network 122 and / or any other suitable communication networks. For example, communications systems 118 can include one or more transceivers, one or more communication chips and / or chip sets, and so on. In a more particular example, the communications systems 118 can include hardware, firmware, and / or software that can be used to establish a Wi-Fi connection, a Bluetooth connection, a cellular connection, an Ethernet connection, and so on.

[0027] In some configurations, the memory 120 can include any suitable storage device or devices that can be used to store instructions, values, data, or the like, that can be used, for example, by the controller 112 or the wearable device 102 to present content using display 114, to communicate with a server 124 via communications system(s) 118, and so on. The memory 120 can include any suitable volatile memory, non-volatile memory, storage, or any suitable combination thereof. For example, the memory 120 can include random-access memory (“RAM”), read-only memory (“ROM”), electrically programmable ROM (“EPROM”), electrically erasable ROM (“EEPROM”), other forms of volatile memory, other forms of non-volatile memory, one or more forms of semi-volatile memory, one or more flash drives, one or more hard disks, one or more solid state drives, one or more optical drives, and so on. In some configurations, the memory 120 can have encoded thereon, or otherwise stored therein, a computer program for controlling operation of computing device 110. In such configurations, the processor / controller 112 (and / or a signal processor 106 of the wearable device 102) can execute at least a portion of the computer program. In doing so, information can be presented (e.g., images, user interfaces, graphics, tables), content can be received from the server 124, and so on. For example, the controller 112 and thememory 120, and / or local processors and memory of the wearable device 102 can be configured to perform the methods described herein.

[0028] The server 124 can include a communications system 126 for communicating, for example, via the communication network 122. The server 124 can also include a processor / controller 128, a display 130, one or more inputs 032, and / or memory 134. As described with respect to the computing system, the controller 128 can be any suitable hardware processor or combination of processors, such as a CPU, a GPU, and so on. The display 130 can include any suitable display devices, such as an LCD screen, LED display, OLED display, electrophoretic display, a computer monitor, a touchscreen, a television, and so on. The input 132 can include any suitable input devices and / or sensors that can be used to receive user input, such as a keyboard, a mouse, a touchscreen, a microphone, and so on. The communications systems 126 can include hardware, firmware, and / or software that can be used to establish a Wi-Fi connection, a Bluetooth connection, a cellular connection, an Ethernet connection, and so on. Finally, the memory 134 can include any suitable volatile memory, non-volatile memory, storage, or any suitable combination thereof.

[0029] As shown in Fig. 1, the energy harvester 104 may be configured to detect masseter movement and or temporalis movement (104a). In one, non-limiting configuration, the energy harvester 104 may be a piezoelectric energy harvester configured to detect temporalis / masseter movement and produce electrical signals for the further characterization of bruxism and storage of energy. For example, referring now to Fig. 2A, such a piezoelectric energy harvester 200 may be formed of one or more flexible piezoelectrical layers 202. That is, as illustrated in Fig. 2B, the piezoelectric energy harvester 200 may include a number of piezoelectric layers 202a.. . 202n.

[0030] Thus, the energy harvester 200 can be constructed by stacking up multiple single layer piezoelectric harvesters. Multiple the single piezoelectric harvesters can be vertically stacked to form a uniform pad. In this structure, each piezoelectric material in the single layer harvester can be isolated from each other to avoid the charge neutralization. The positive / negative conductive sides can be carefully connected, while isolated from the negative sides for the magnification of power output. Such design gives piezoelectric signal output in the form of electrical voltage, which can be transduced into the subsequent components by surface printed wires.

[0031] Referring to Figs. 2A and 2B, each piezoelectrical layer may be fabricated with a thickness at range of micrometers. Multiple piezoelectrical layers 202a-202n can be stacked into a uniformpiezoelectrical energy harvest pad for the magnification of electrical signals output. The thickness of the pad may be less than 2mm for patient comfort.

[0032] In one non-limiting example, any of a variety of materials can be selected, which can (for example) include PVDF (polyvinylidene fluoride), PVDF-TrFE(polyvinylidene fluoride- trifluoro ethylene), PHBV (poly- 3- hydroxybutyrate-3 -hydroxy valerate), polyamides, PLLA(poly-l-lactic acid), and the like. By using the polymer material, such as PVDF, the thickness of the harvester film can be fabricated into micrometer level. A common piezoelectric energy harvester made of PVDF can be fabricated with thickness of ~30um with the weight of milligrams. Thus, maintain a thickness of the overall energy harvester of less than 2mm allows for stacking roughly 50 single harvester layers to produce instantaneous power rate up to milliwatts. The energy harvester may be embedded into a thin polyester substrate for free deformation at all dimensions.

[0033] In addition to the one or more piezoelectrical layers 202a-202n, the piezoelectric energy harvester 200 may be formed on a substrate 204. The substrate may include an adhesive layer 205 configured to attach the piezoelectric energy harvester 200 to skin for extended periods of time. In addition, the piezoelectric energy harvester 200 may include an energy storage device 206, which may include a capacitor, battery, or the like.

[0034] During teeth grinding, the deformation of the one or more piezoelectrical layers 202a-202n aligned with temporalis and / or masseter movement causes the one or more piezoelectrical layers 202a-202n to produce electrical signals. The one or more piezoelectrical layers 202a-202n may include metallization such as silver ink for electrical conduction. In addition to storing energy created by the one or more piezoelectrical layers 202a-202n, these signals are passed to the signal processor 106 of Fig. 1. As mentioned, the signal processor 106 may be passive filter designed to only transmit the signals with produced by bruxism. Additionally or alternatively, the signal processor 106 may include a computer processor, as described above.

[0035] During external mechanical stress caused by masseter / temporalis contractions during bruxism, piezoelectrical material deforms and generate positive / negative potentials across the upper and lower sides. The potential is connected to other electronic devices using printed wires and generates electrical signals.

[0036] Regardless of whether the signal processor 106 is passive signal fdter or an active processor that performs fdtering, the wearable device 102 characterizes the muscle movement signal produced by the piezoelectrical energy harvester 102. That is, the signal processor 106 candistinguish bruxism related teeth grinding signal by magnitude, frequency, and signal duration. In one non-limiting configuration, the signal processor 106 may be constructed with passive electronic units, such as resistors, capacitors, inductors, transistors, diodes. In doing so, power consumption is minimized and, for example, the size of the energy storage device 206 of Figs. 2A and 2B is minimized and / or no energy storage device 206 may be included. In one non-limiting example, the signal processor 106 may include a bandpass filter, magnitude filter, and storage capacitor. The bandpass filter may be responsible for selecting signals at the desired frequencies, the magnitude filter may be responsible for selecting the signals with desired magnitudes, and the capacitor may be responsible for selecting signals with desired durations. Overall, a passive signal filter may be designed to maintain the signals from teeth grinding caused by bruxism and block the signals produced by other activities such as chewing, speaking, and drinking. Alternatively, the signal processor 106 may include a processor that uses algorithmic analysis or machine learning to distinguish signals from teeth grinding caused by bruxism and block the signals produced by other activities such as chewing, speaking, and drinking.

[0037] Referring to Fig. 2B, if the energy storage device 206 is included, a power management unit 208 may, optionally, be included. The power management unit 208 may be designed to store the harvested electrical energy in the storage device 206. By accumulating the charges, the voltage of such battery or capacitor increases, and once it passes through the threshold, the power management unit 208 may automatically turn the storage into a power supply. The energy may be then used to generate biofeedback, such as tiny vibrations or sound, to notify the patients about their teeth grinding behavior. In one, non-limiting example, the power management unit 208 can integrate a low-loss, full-wave bridge rectifier with a high efficiency buck converter to form an energy harvesting solution optimized for high output impedance energy sources, such as piezoelectric materials. A wide hysteresis window may be also involved to allow charge to accumulate on a storage unit, such as a capacitor, until the buck converter can transfer the stored charge to the output side. To trigger the biofeedback only at bruxism, a pre-determined threshold may be used that is experimentally defined is applied to the power management unit 208 during powering stage.

[0038] Thus, as illustrated in Fig. 1, the wearable device 102 may be engineered with a structure like a self-adhesive bandage, which can be attached to the facial skin. During bruxism, mechanical energy produced from muscle contractions can be collected by the energy harvester 104. Signalswith characteristics similar to bruxism will pass the signal processor 106, and can be saved inside an energy storage device. Once the stored energy surpasses the preset threshold, the feedback device 108 delivers feedback to the patient 109.

[0039] That is, referring to Fig. 3, during bruxism, repeated jaw muscle contractions produce a stable mechanical energy, which can be harvested by the energy harvester described above. The harvested electrical signal can be selected by the signal processor and only the bruxism-like voltage signal will be stored. Once the stored energy surpass the threshold, the power management unit can release the power stored in power supply and trigger feedback signal to help the patient cease bruxism.

[0040] In one non-limiting example, a series of graphs of a piezoelectric signal collected by a signal layer harvester arranged above a masseter muscle of a patient during different activities is shown in Fig. 4. Within twenty seconds, the patient was asked to perform teeth clenching, chewing, speaking, and drinking wearing the piezoelectric energy harvester. The signal exhibit the unique characteristics of masseter movement during teeth clenching compared to other activities such as constant frequency and magnitude.

[0041] Thus, it is clear that signal processing using even passive components can be used to implement the systems and methods of the present disclosure, which means very cheap and even disposable systems can be constructed. In this case, the signal processor functions mainly based on the different intrinsic characteristics between jaw muscle movement caused by teeth grinding at bruxism and other activities such as eating, speaking, and drinking. There are three main characteristics of the signal: magnitude, frequency, and signal duration. Based on these, the signal processor can be fabricated of three components: bandpass filter, magnitude filter and storage capacitor.

[0042] As can be seen in Fig. 4, the teeth grinding caused by bruxism is performed at a signature frequency, which may vary by individuals but is generally constrained at a narrow frequency range between 1 - 5Hz. Using this as a non-limiting example, the bandpass filter can selectively pass the signal which owns the frequency between l-5Hz while blocking others such as high frequency noise or irregular muscle movement caused by speaking. A bandpass filter constructed of resistors and capacitors are shown in Fig. 5. During clinical application, components on the signal processor can be precisely determined to fulfill the task while drawing the minimum energy from the electrical signal. All electronic units can be surface mounted on a flexible printed circuit board(FPCB) as connected with energy harvester, for example, using printed route. Such bandpass fdter does not need external supply, which can be advantageous for creating a design that is small or unintrusive and inexpensive, or even disposable.

[0043] The magnitude filter can function to select the piezoelectric singles based on the signal amplitude. As showed in Fig. 4, compared to other jaw muscle associated activities, teeth grinding caused by bruxism exhibits larger peak amplitude due to intensive muscle contractions, which can be utilized for characterization. The magnitude filter can be made of passive units such as a diode, which only passes signals above its knee point during forward biasing. Other components may also be used, such as controlling the signal flow through a metal-oxide-semiconductor field-effect transistor (MOSFET) by providing large enough gate-source voltage can also be used. The component, again, can be designed to draw minimum power through the signal and be small and cost efficient. All the electronic units can be surface mounted on the FPCB due to their small size.

[0044] A further considered characteristic of piezoelectric signal can be the duration. During bruxism, teeth grinding lasts significantly longer than other jaw muscle associated activities, which is usually at several minutes. To utilize this feature, the signal processor can apply a capacitor as storage device. The technical specifications of this capacitor can be carefully designed, even for a particular patient’s characteristics of bruxism. That is, the capacitor can be selected to match capacitance, regulated voltage, and leakage current rating to the characteristics of the patient’s implementation of bruxism, teeth grinding. The regulated voltage can be selected to be sufficient for the peak voltage charging process, while the capacitance can be selected for the fast response time. The current leakage rate can be selected so that only piezoelectric signal with extended durations can successfully build up the charge and lead the capacitor voltage exceed the predetermined threshold. A non-limiting example of a circuit for a passive signal processor is shown in Fig. 6. The circuitry can be surface mounted on FPCB and embedded inside the polyester substrate as a thin pad for the purpose of concealment.

[0045] A power management unit (PMU) can be employed and integrated into the device as the main voltage and energy regulator. The piezoelectric signal produced by the harvester can be provided to the signal processor, among which produced exclusively by bruxism is stored. PMU can associate two capacitor energy storage in this process: the storage capacitor (C_storage) in the signal fdter and another output capacitor (C output) as the power supply. During electrical energystorage process, the voltage level of C_storgage is below the preset threshold and PMU will shut down the DC-DC buck converter and block any voltage output due to the hysteresis window.

[0046] If voltage level of C storage surpasses the threshold, the MOSFET inside the buck converter is activated and the energy stored in C storage is converted to C output. When the energy of C output is consumed and the corresponding voltage drops below the threshold, buck converter will automatically shut off again to stop the power supply. One non-limiting example of a PMU configured in this regard is shown in Fig. 7.

[0047] Such a PMU can be created using components on the commercialized electronic market such as LTC3588 (Nanopower Energy Harvesting Power Supply, Analog Devices) or BQ25504 (Ultra Low Power Boost Converter with Battery Management for Energy Harvester, Texas Instrument). Such devices are maturely built for nanopower regulation purposes which is suitable for the device design.

[0048] Fig. 8 shows the voltage level of a 22uF capacitor, where the charge was collected by the prementioned piezoelectric energy harvester made by 28pm thick PVDF. The power management process was managed by the LTC3588. It is estimated that the entire energy power rate of such an energy harvester during bruxism is 1.584pW / cmA2. However, by applying piezoelectric material with better performance, such as 6 wt% of single-wall carbon nanotubes (SWCNTs) combined PVDF, which produces a power rate of 28 pW / cm2, or PVDF-FeTiNbO6 / PVDF and produces a power rate of 110pW / cmA3, it is positive that we can collect higher amount of energy (mJ level) during bruxism episodes. By consuming the energy at instant, the system is able to power unit at mW level for a short amount of period, which is enough for feedback purposes.

[0049] A device for generating biofeedback during bruxism may be designed and integrated into the device. Considering that piezoelectric energy harvester owns high input impedance, which only produce power at maximum milliwatts level, if creating the system from passive components as described above, such biofeedback should consume power at same power level as well.

[0050] Proper types of biofeedback can be selected based on individuals and regulatory rules, popular choices are vibrations, sounds, temperature, gentle electric stimuli, and light. The dosimetry can be carefully selected for the patient and include minor electric shock, haptic feedback, sounds, changes in temperature, or light. Other than these mentioned types of biofeedback which react directly on the individual’ s skin, the feedback can also be a piece of signalsent out to mobile phone or wearable device, such as through Bluetooth low energy (BLE) method, to further trigger other types of notifications.

[0051] In the above-described passive system, and considering the voltage level (~ 1.5V) and current level (l~5mA) that can be produced through the harvested energy, tiny buzzers (PKMCS0909E4000-R1, Murata Electronics), low-power LEDs (EAST1410RGBW01, Everlight) and logit units can used.

[0052] In this configuration, the energy harvester can be placed on the skin above the temporalis / masseter muscle. Signal filters and biofeedback generators, which may appear bulky, can be connected, and placed at the back of the ear. During daily wear, this device will cause minimum distractions to the individual, while only notifying the patient at bruxism period. The device can be used during night as well since it will not hinder sleep due to its tiny size. The selfpower ability enables the device to be designed as flat and small as possible as it gets rid of batteries. The device does not require the individual to take care of its power supply, which can extend the wearing period.

[0053] Testing data shows that facial strain, as assessed through a piezoelectric sensor, exhibits discernible differences among the varies functions that jaw muscles are involved in such as chewing, speaking, drinking and teeth clenching. Notably, the voltage signal recorded by the piezoelectrical sensor during teeth clenching demonstrates distinct characteristics, including a consistent frequency, specific amplitude, and prolonged duration, distinguishing it from other jaw muscle activities. This indicates that i) the adjacent facial skin to the target muscles can serve as an indicator for bruxism and ii) the mechanical energy generated during teeth clenching remains stable and may be harnessed during episodes of bruxism.

[0054] Thus, in the most fundamental configuration, referring to Fig. 9, a method 900 for diagnosing and / or treating bruxism may include detecting muscle movement using a sensor at process lock 902. At process block 904, the acquired signals are processed, for example, through a passive signal filter. When the signal processor (whether passive or active) determines that the signal is indicative of bruxism, biofeedback is generated and delivered to the patient at process block 908. Optionally, at process block 910, feedback may also be provided elsewhere, such as to a computer or other wearable device, which may generate a separate or alternative report that supplements or replaces the biofeedback of process block 908.

[0055] EXAMPLE

[0056] In one, non-limiting example, a clinical test was conducted using multiple patients. A piezoelectric sensor (50 um PVDF, LDT0-028K, TE Connectivity) was covered with isolation tape was adhered to the facial skin above the masseter muscle using double-sided foam tape (Gorilla brand). The sensor’s signal was transmitted to the controller board via coaxial cables, with the controller clipped to the patient's collar. In 4 out of 10 patients, the device also provided feedback via a vibratory signal. The vibrator was placed on the skin based on the patient’s preference.

[0057] An experimental procedure was followed that included placing the piezoelectric sensor on the patient's cheek, above the masseter muscle. The patient was instructed to clench their teeth at varying force levels (light, moderate, heavy). The sensor's output was recorded for each force level, and the threshold and frequency for moderate clenching were calculated. The device firmware was updated with customized parameters based on the threshold and frequency data.

[0058] Patients then followed a behavior study protocol that included: 1 minute of teeth clenching, 3 minutes of idling, repeated three times, with the last idling only 1 minute. During this period, device diagnoses were recorded, comparing the detected clenching events with manual counts. True positives (TP), true negatives (TN), false positives (FP), and false negatives (FN) were logged, and performance metrics were calculated. Finally, patient feedback on the device experience was collected. Table 1 provides information about this experiment.Table 1

[0059] In table 1, the * indicates that feedback was initiated during the test and the following describes the parameters: Accuracy = (True Positive (TP) + True Negative (TN) ) / (Total prediction); Precision = TP / (TP + False Positive (FP)); Sensitivity = TP / (TP + False Negative (FN)); Specificity = TN / (TN+FP); Fl score = 2*(Precision*Sensitivity / (precision + Sensitivity)).

[0060] The overall performance metrics, including accuracy, precision, sensitivity, specificity, and Fl score, were calculated for each patient. These values were summarized in a box plot in Fig. 10. The highest observed value was specificity, averaging 92%, while precision was lower, at approximately 84%.

[0061] The device demonstrated strong specificity due to the optimized threshold settings, which reduced the false-negative rate. Only clenching events classified as moderate or heavy were detected. Variability in patient clenching patterns and signal detection caused precision to be lower. Some clenching events were missed, and this was attributed to the individualized nature of the customized parameters. The overall accuracy was -91%, predominantly influenced by the high specificity. However, the sensitivity was lower, as expected, due to the small sample of true positives relative to the total number of non-clenching periods. An average Fl score of 85% suggests consistent device performance across the patient cohort, with limited variability in individual results.

[0062] The high specificity of the device can be attributed to the carefully chosen diagnostic mechanism, which only detects clenching events that meet the preset thresholds. While this ensures fewer false positives, the trade-off is a reduction in precision due to missed detections. The study design, which incorporated longer idling periods, may have introduced bias into the accuracy calculations.

[0063] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The present disclosure is readily extended to other aspects and implementations and may be practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.

[0064] As used herein in the context of computer implementation, unless otherwise specified or limited, the terms “component,” “system,” “module,” “controller,” “framework,” and the like areintended to encompass part or all of computer-related systems that include hardware, software, a combination of hardware and software, or software in execution. For example, a component may be, but is not limited to being, a processor device, a process being executed (or executable) by a processor device, an object, an executable, a thread of execution, a computer program, or a computer. By way of illustration, both an application running on a computer and the computer can be a component. One or more components (or system, module, and so on) may reside within a process or thread of execution, may be localized on one computer, may be distributed between two or more computers or other processor devices, or may be included within another component (or system, module, and so on).

[0065] In the methods described herein, the steps can be carried out in any order without departing from the principles of the disclosure, except when a temporal or operational sequence is explicitly recited. Recitation in a claim to the effect that first a step is performed, and then several other steps are subsequently performed, shall be taken to mean that the first step is performed before any of the other steps, but the other steps can be performed in any suitable sequence, unless a sequence is further recited within the other steps. For example, claim elements that recite “Step A, Step B, Step C, Step D, and Step E” shall be construed to mean step A is carried out first, step E is carried out last, and steps B, C, and D can be carried out in any sequence between steps A and E, and that the sequence still falls within the literal scope of the claimed process. A given step or sub-set of steps can also be repeated.

[0066] Furthermore, specified steps can be carried out concurrently unless explicit claim language recites that they be carried out separately. For example, a claimed step of doing X and a claimed step of doing Y can be conducted simultaneously within a single operation, and the resulting process will fall within the literal scope of the claimed process.

[0067] The term “substantially” or “about” as used herein refers to a majority of, or mostly, as in at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.5%, at least about 99.9%, at least about 99.99%, or at least about 99.999% or more.

[0068] As used in the claims, the phrase “at least one of A, B, and C” means at least one of A, at least one of B, and / or at least one of C, or any one of A, B, or C or combination of A, B, or C. A, B, and C are elements of a list, and A, B, and C may be anything contained in the Specification.

[0069] The following discussion is presented to enable a person skilled in the art to make and use aspects of the disclosure. Various modifications to the illustrated configurations or processes will be readily apparent to those skilled in the art, and the generic principles herein can be applied to other aspects and applications within the scope of the present disclosure and the understanding of one of skill based thereon. Thus, the present disclosure is not intended to be limited to particular embodiments or aspects shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like components or elements fin different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected aspects and configurations or processes and are not intended to limit the scope of the disclosure. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the disclosure.

Claims

CLAIMS1. A system for diagnosing or treating bruxism comprising: a wearable device configured to be coupled to a head of a patient to move as the patient expresses bruxism, the wearable device comprising: an energy harvester configured to detect muscle movement and generate electrical signals in response to the detected muscle movement; and a signal processor configured to process the electrical signals from the energy harvester to provide processes electrical signals indicative of bruxism.

2. The system of claim 1, wherein the energy harvester comprises a piezoelectric energy harvester configured to detect temporalis or masseter movement.

3. The system of claim 1, wherein the energy harvester comprises multiple stacked piezoelectric layers.

4. The system of claim 1, wherein the signal processor comprises a passive filter configured to selectively transmit signals produced by bruxism.

5. The system of claim 4, wherein the passive filter comprises a bandpass filter, a magnitude filter, or a storage capacitor.

6. The system of claim 1, further comprising a feedback device configured to provide biofeedback to the patient based on the processed electrical signals.

7. The system of claim 6, further comprising a power management unit configured to store harvested electrical energy and trigger the feedback device when stored energy surpasses a preset threshold.

8. The system of claim 6, wherein the feedback device is configured to provide at least one of electrical signal, vibration, sound, temperature change, or light as biofeedback to the patient.

9. The system of claim 1, wherein the signal processor includes a computer processor.

10. A method for diagnosing or treating bruxism, comprising: detecting muscle movement using a sensor positioned on a head of a patient; processing signals acquired from the sensor to identify processed signals indicative of bruxism; and delivering biofeedback to the patient when the processed signals are indicative of bruxism to alert the patient of a bruxism event or to discontinue activities inducing the muscle movement.

11. The method of claim 10, wherein processing signals includes using a piezoelectric energy harvester configured to detect temporalis or masseter movement of the patient.

12. The method of claim 10, wherein processing signals acquired from the sensor comprises filtering the signals using a passive filter configured to selectively transmit signals produced by bruxism.

13. he method of claim 12, wherein the passive filter comprises a bandpass filter, a magnitude filter, and a storage capacitor.

14. The method of claim 10, wherein generating biofeedback comprises providing at least one of vibration, sound, temperature change, or light to the patient.

15. A piezoelectric energy harvester for use in a bruxism diagnosis or treatment system, comprising: a flexible substrate; a plurality of piezoelectric layers stacked on the flexible substrate, each piezoelectric layer configured to generate electrical signals in response to deformation caused by muscle movement; and an adhesive layer configured to attach the piezoelectric energy harvester to facial skin of a patient to position the plurality of piezoelectric layers to detect temporalis or masseter movement of the patient.

16. The piezoelectric energy harvester of claim 15, wherein the plurality of piezoelectric layers comprise poly vinylidene fluoride (PVDF).

17. The piezoelectric energy harvester of claim 15, wherein the flexible substrate comprises polyester.

18. The piezoelectric energy harvester of claim 15, further comprising an energy storage device configured to store electrical energy generated by the piezoelectric layers.

19. The piezoelectric energy harvester of claim 18, further comprising a power management unit configured to regulate the storage and release of electrical energy from the energy storage device.

20. The piezoelectric energy harvester of claim 19, wherein the power management unit is configured to release stored electrical energy when a predetermined threshold is reached to trigger a feedback signal for bruxism treatment.

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