Wireless intraoral genioglossus myoelectricity acquisition device and functional electrical stimulation system thereof

Abstract

The utility model discloses a wireless intraoral genioglossus myoelectricity acquisition device and a functional electrical stimulation system thereof. According to the myoelectricity acquisition device, the electrode, the myoelectricity acquisition circuit and the wearable tooth socket are fixedly assembled and are subjected to waterproof packaging, and the technical scheme of wireless transmission and wireless charging is matched, so that the accuracy of signal acquisition and the wearing comfort of a user are effectively improved, and the myoelectricity acquisition device is suitable for being worn in a humid oral environment for a long time. According to the corresponding closed-loop functional electrical stimulation system, electromyographic signal monitoring and electrical stimulation are integrated, the activity state of genioglossus can be monitored in real time, and electrical stimulation is provided when necessary, so that the smoothness of the airway is maintained, and the breathing problem caused by airway collapse is effectively prevented. The system can also automatically adjust stimulation parameters according to real-time feedback of electromyographic signals, improves the accuracy and curative effect of treatment, and is particularly suitable for treating obstructive sleep apnea.

Description

Technical Field

[0001] The utility model relates to a wireless intraoral genioglossus electromyogram acquisition device, and also relates to a closed-loop functional electrical stimulation system adopting the electromyogram acquisition device, belonging to the technical field of medical devices. Background Technique

[0002] Obstructive Sleep Apnea (OSA) is a common sleep disorder associated with various chronic diseases, including coronary heart disease, hypertension, arrhythmia, type II diabetes, cerebrovascular disease, and cognitive dysfunction. OSA patients often experience sleep interruption and apnea at night, leading to daytime sleepiness and increasing the risk of traffic accidents. The medical community has paid high attention to this because it has a significant impact on both health and society.

[0003] The pathogenesis of OSA involves multiple physiological factors, especially the abnormal function of the nerve-upper airway dilator muscles, which play a key role in maintaining airway patency during sleep. The genioglossus, as the main upper airway dilator muscle, its abnormal function may lead to airway collapse and apnea. Therefore, monitoring the activity of the genioglossus is crucial for the diagnosis and treatment of OSA.

[0004] Currently, Genioglossus Electromyography (GGEMG) is the main method for monitoring the activity of the genioglossus. Traditional electromyogram signal acquisition methods include invasive needle electrodes and non-invasive surface electrodes. Although the invasive method is accurate, it is not suitable for long-term monitoring. The non-invasive extraoral surface electrodes are convenient, but their accuracy is limited. Intraoral surface electrodes provide a more accurate monitoring method, but the existing technology still needs to be improved because they usually need to lead the electrode wire from the inside of the mouth to the outside of the mouth, which affects the user's comfort and the natural closure of the mouth.

[0005] On the other hand, in the Chinese invention patent with the patent number ZL 201210592267.5, a non-invasive transcutaneous variable-frequency electrical stimulation multi-functional respiratory treatment device is disclosed, which includes a real-time monitoring module for monitoring the respiratory condition, used to monitor the respiratory condition of the monitored object in the sleep state in real time and obtain sleep parameters; an electrical stimulation signal generation module for providing at least two electrical stimulation modes; a non-implanted transcutaneous electrode for conducting the chronic variable-frequency electrical stimulation signal to the diaphragm or genioglossus muscle of the monitored object; or conducting the acute electrical stimulation signal to the diaphragm or genioglossus muscle of the monitored object. This treatment device can integrate multiple functions such as acute diaphragm pacing, chronic variable-frequency diaphragm electrical stimulation, acute genioglossus muscle electrical stimulation, and variable-frequency genioglossus muscle electrical stimulation. It can not only terminate apnea events and reverse hypoxia through acute electrical stimulation treatment, but also improve the contraction ability and anti-fatigue ability of the diaphragm and genioglossus muscle through variable-frequency electrical stimulation treatment, having dual effects of treatment and prevention. However, there are still some areas that need further improvement in this treatment device, including: the comfort of long-term wearing and the compliance of users need to be improved; the personalization and adaptability of electrical stimulation need to be adjusted according to the specific situation of users, etc. Summary of the Invention

[0006] The primary technical problem to be solved by the present utility model is to provide a wireless intraoral genioglossus muscle electrical signal acquisition device.

[0007] Another technical problem to be solved by the present utility model is to provide a closed-loop functional electrical stimulation system using the wireless intraoral genioglossus muscle electrical signal acquisition device.

[0008] In order to achieve the above object, the present utility model adopts the following technical solutions:

[0009] According to the first aspect of the embodiment of the present utility model, a wireless intraoral genioglossus muscle electrical signal acquisition device is provided, including a wearable dental appliance, electrodes, and an EMG acquisition circuit; wherein,

[0010] The EMG acquisition circuit is connected to the electrodes, and both the EMG acquisition circuit and the electrodes are fixedly installed on the wearable dental appliance and are integrally formed after overall waterproof encapsulation, and are worn on the lower jaw teeth in the oral cavity and meshed with the teeth during use;

[0011] The wearable dental appliance is used as a carrier for fixedly installing the EMG acquisition circuit and the electrodes;

[0012] The electrodes include two acquisition electrodes and one grounding electrode, and are used to collect the electrophysiological activity signals of the genioglossus muscle in real time;

[0013] The EMG acquisition circuit is used to convert and process the genioglossus muscle EMG signals collected by the electrodes and then send them to the host computer.

[0014] Preferably, the wearable dental appliance is prepared by using a formed transparent film sheet through a dental laminating machine according to the mandibular tooth model of the user; or, it is prepared by using a thermoplastic dental appliance that becomes soft in hot water and is bite-molded by the user.

[0015] Preferably, the electrode is made of titanium metal, the collecting end is spherical, the end is an electrode wire, and after drilling holes in the spherical collecting end, the connection with the electrode wire is achieved by interference fit.

[0016] Preferably, the two collecting electrodes are positioned at the gap between the canine and lateral incisor of the mandibular teeth of the wearable dental appliance, and the grounding electrode is positioned at the midline of the lower front teeth of the wearable dental appliance, and are respectively fixed to the inner side and the outer side of the wearable dental appliance.

[0017] Preferably, the spherical collecting end of the collecting electrode contacts the genioglossus muscle eminence, the spherical collecting end of the grounding electrode contacts the labial gingiva below the midline of the lower front teeth, and the ends of the electrodes are all connected to the electromyogram collecting circuit.

[0018] Preferably, the electromyogram collecting circuit includes a signal processing unit, an analog-to-digital conversion unit, a wireless transmission unit, a power management unit, a wireless charging unit and a battery; wherein,

[0019] The input end of the signal processing unit is connected to the electrode, and the input and output ends of the signal processing unit, the analog-to-digital conversion unit and the wireless transmission unit are connected in sequence;

[0020] The first input end of the power management unit is connected to the battery, the second input end is connected to the wireless charging unit, and the output end is respectively connected to the power supply ends of the signal processing unit, the analog-to-digital conversion unit and the wireless transmission unit;

[0021] The signal processing unit is used to amplify and filter the electromyogram signal collected by the electrode and then output it to the analog-to-digital conversion unit;

[0022] The analog-to-digital conversion unit is used to sample the input analog electromyogram signal and convert it into a digital electromyogram signal and output it to the wireless transmission unit;

[0023] The wireless transmission unit is used to send the digital electromyogram signal to achieve wireless communication with the host computer;

[0024] The power management unit is used to provide working power for the signal processing unit, the analog-to-digital conversion unit and the wireless transmission unit. At the same time, the wireless charging unit charges the battery through the power management unit.

[0025] Preferably, the circuit board part in the electromyogram acquisition circuit is manufactured by using the flexible printed circuit board technology; wherein,

[0026] The circuit board is divided into three rectangular areas. The rectangular areas on both sides are used to place chips and electronic components, and the rectangular area in the middle is used to be fixedly connected with the electrodes. The three rectangular areas are connected by serpentine wires to achieve the stretchability of the circuit board;

[0027] The rectangular areas on both sides of the circuit board are fixed on the buccal side of the molar teeth of the wearable dental appliance, and the rectangular area in the middle is fixed on the labial side of the incisor teeth of the wearable dental appliance.

[0028] Preferably, the wearable dental appliance is encapsulated by using the secondary film covering process; wherein, the electrodes, the circuit board, the battery, and the charging coil are first fixed and sealed by coating food-grade silica gel around the wearable dental appliance, and then the entire wearable dental appliance is covered and sealed by using a food-grade plastic film through a dental laminating machine. The edges of the food-grade plastic film and the wearable dental appliance are adhesively sealed by food-grade silica gel to achieve overall waterproof encapsulation.

[0029] According to the second aspect of the embodiment of the present invention, a closed-loop functional electrical stimulation system is provided, including the above-mentioned wireless intraoral genioglossus electromyogram acquisition device, an electrical stimulation module, and a control module; wherein,

[0030] The wireless intraoral genioglossus electromyogram acquisition device sends the acquired electromyogram signals to the host computer, the host computer transmits the analysis result to the control module, and the control module makes an intelligent decision to generate a control signal; after receiving the control signal, the electrical stimulation module applies a customized electrical stimulation to the genioglossus muscle through the electrodes;

[0031] After applying the electrical stimulation, the wireless intraoral genioglossus electromyogram acquisition device captures new electromyogram signals to form a closed-loop feedback.

[0032] Compared with the prior art, the wireless intraoral genioglossus electromyogram acquisition device provided by the embodiment of the present invention effectively improves the accuracy of the acquired signals and the comfort of the user's wearing by fixedly assembling the electrodes, the electromyogram acquisition circuit and the wearable dental appliance and performing waterproof encapsulation, and by means of the technical solutions of wireless transmission and wireless charging, making it suitable for long-term wearing in the moist oral environment. The corresponding closed-loop functional electrical stimulation system integrates electromyogram signal monitoring and electrical stimulation, can monitor the activity state of the genioglossus muscle in real time, and provide electrical stimulation when necessary to maintain the patency of the airway and effectively prevent respiratory problems caused by airway collapse. The system can also automatically adjust the stimulation parameters according to the real-time feedback of the electromyogram signals, improving the accuracy and efficacy of the treatment, and is especially suitable for treating obstructive sleep apnea (OSA). Brief Description of the Drawings

[0033] Figure 1A and Figure 1B are respectively schematic structural diagrams of a wireless intraoral genioglossus electromyogram acquisition device provided by an embodiment of the present invention at different angles;

[0034] Figure 2 is a schematic diagram of the structure and installation process of the electrode in an embodiment of the present invention;

[0035] Figure 3 is a principle block diagram of the electromyogram acquisition circuit in an embodiment of the present invention;

[0036] Figure 4 is a schematic diagram of the external shape design of the circuit board in an embodiment of the present invention;

[0037] Figure 5 is an exploded view of the overall structure of the electromyogram acquisition device in an embodiment of the present invention.

[0038] Figure 6 is a schematic diagram of the electromyogram signal collected by the wireless intraoral genioglossus electromyogram acquisition device in an embodiment of the present invention;

[0039] Figure 7 is a schematic structural diagram of a closed-loop functional electrical stimulation system provided by an embodiment of the present invention. Detailed Embodiment

[0040] The technical content of the present invention will be described in detail below with reference to the drawings and specific embodiments.

[0041] As Figure 1A and Figure 1B shown, a wireless intraoral genioglossus electromyogram acquisition device (abbreviated as electromyogram acquisition device) provided by an embodiment of the present invention includes a wearable dental appliance 1, electrodes 5, 50, an electromyogram acquisition circuit 2, 3, 4, and a host computer (not shown in the figure). Among them, the electromyogram acquisition circuit is connected to the electrodes, and both the electromyogram acquisition circuit and the electrodes are fixedly installed on the wearable dental appliance, and are integrally formed after overall waterproof encapsulation, and are worn on the lower jaw teeth in the mouth and meshed with the teeth during use.

[0042] The wearable dental appliance is a special dental appliance for electromyogram acquisition, which is used as a carrier to fixedly install the electromyogram acquisition circuit and the electrodes. It is worn on the user's lower jaw teeth and meshed with the teeth during use.

[0043] The electrodes include two acquisition electrodes 5 and one ground electrode 50, which are used to collect the electrophysiological activity signals of the genioglossus muscle in real time. During use, the two acquisition electrodes extend to the floor of the mouth and contact the genioglossus muscle bulge, and the ground electrode contacts the gingiva on the labial side below the midline of the lower incisors.

[0044] The electromyogram acquisition circuit is used to convert and process the genioglossus electromyogram signals collected by the electrodes and then send them to the host computer, and specifically includes a circuit board 2, a battery 3 and a charging coil 4.

[0045] The host computer is used to receive the genioglossus electromyogram signal data in real time, and perform relevant calculations, data storage and display.

[0046] In an embodiment of the present invention, in order to ensure the comfort and reliability of the wearable dental appliance during wearing, the dental appliance needs to be made according to the user's mandibular tooth model. The user's mandibular tooth model can be obtained by taking an oral impression and preparing a plaster model, or a digital model can be obtained by an intraoral scanner and then obtained by 3D printing. The dental appliance is made of a formed transparent film with a thickness not greater than 1 mm. This film has good wearing comfort and can reduce the foreign body sensation of the user. Then, a dental laminating machine is used to form and prepare the dental appliance. In addition, in order to improve the convenience of use, in another embodiment of the present invention, the dental appliance can be replaced with a thermoplastic dental appliance. The thermoplastic dental appliance becomes soft in hot water and is then placed in the user's mouth for biting, and can be formed into a dental appliance that fits the user's mandibular teeth, which is convenient and fast to use.

[0047] In an embodiment of the present invention, as Figure 2 shown, the collection end of the electrode is spherical, the diameter of the sphere is 3 mm, the spherical collection end is connected to the electrode wire, the diameter of the electrode wire is 0.6 mm, and both are made of titanium metal with good biocompatibility. When the spherical collection end is connected to the electrode wire, first a hole is drilled in the spherical collection end, the electrode wire is inserted into the hole, and the two are connected by interference fit. Then, the electrode wire part is insulated and encapsulated with a heat shrinkable tube. Since the electrode wire is hard in texture and its shape is plastic, it is convenient to adjust the position of the electrode in the mouth. Among them, the two collection electrodes are positioned at the gap between the mandibular canine and lateral incisor of the dental appliance, and are respectively fixed to the inner side and the outer side of the dental appliance. The distance between the two collection electrodes is about 10-15 mm, and can be adjusted through the electrode wire. The collection electrodes extend downward from the upper edge of the tooth crown by about 35 mm. The spherical collection end of the collection electrode contacts the genioglossus eminence, and the other end of the electrode wire is connected to the electromyogram acquisition circuit by plugging. The grounding electrode 50 is positioned at the midline of the lower front teeth of the wearable dental appliance, its spherical collection end contacts the labial gingiva below the midline of the lower front teeth, the grounding electrode extends downward from the upper edge of the tooth crown by about 20 mm, and the other end of the electrode wire is connected to the electromyogram acquisition circuit by plugging.

[0048] In addition, in other embodiments of the present invention, the spherical collection end of the electrode and the electrode wire can also be made of other conductive materials such as silver, silver chloride, conductive hydrogel, conductive polymer, etc. to realize the collection of genioglossus electromyogram signals.

[0049] In terms of the selection of electrode materials, traditional silver or silver chloride electrodes are widely used for surface electrophysiological signal acquisition due to the stability of their electrochemical properties and the accuracy of recorded signals. However, in the intraoral scenario, the problem of poor biocompatibility cannot be ignored. Electrode materials such as gels and conductive pastes are wet electrodes, and their performance will decline over time due to the gradual drying of the electrodes. Titanium is a metal material with good biocompatibility. Using titanium metal as the electrode material has the advantages of safety and stability. However, titanium metal has poor welding performance and cannot electrically connect the spherical acquisition end to the electrode wire through soldering. Therefore, the embodiment of the present utility model proposes a preparation process of a titanium electrode based on interference fit, connecting a plastic titanium metal wire to a titanium metal ball with a hole of the same size, solving the problem of difficult welding of titanium metal on a micro scale. Specifically, the electrode consists of two parts, one part is the spherical electrode (titanium metal ball), and the other part is the electrode wire (titanium metal wire). The diameter of the spherical electrode is about 3 mm, and the diameter of the electrode wire is about 0.6 mm. During the preparation process, first, a titanium metal ball with a hole of the same size as the diameter of the electrode wire needs to be prepared. Then, the titanium metal wire is inserted into this hole. The so-called interference fit means inserting a component (here the electrode wire) into the hole of another component (here the spherical electrode), and through a certain pressure or heat treatment, making the two fit tightly to form a whole. This fitting method does not require welding, thus solving the problem of difficult welding of titanium metal on a micro scale. After the electrode wire is inserted into the hole of the spherical electrode, it is fixed through interference fit. This fixing method can ensure the stability of the electrode during use and will not loosen due to changes in the oral environment. In addition, in order to ensure the safety and stability of the electrode wire, the electrode wire is insulated and encapsulated with a heat shrink tube to prevent current leakage or other electrical problems. The prepared electrode is positioned at the gap between the mandibular canine and lateral incisor of the dental appliance and fixed to the inner and outer sides of the dental appliance. Such a design is to ensure that the electrode can accurately contact the genioglossus muscle eminence, thereby effectively collecting electromyographic signals.

[0050] In an embodiment of the present utility model, as Figure 3 shown, the electromyographic acquisition circuit includes a signal processing unit, an analog-to-digital conversion unit, a wireless transmission unit, a power management unit, a wireless charging unit, and a battery. Among them, the input end of the signal processing unit is connected to the electrode, and the input and output ends of the signal processing unit, the analog-to-digital conversion unit, and the wireless transmission unit are connected in sequence; the first input end of the power management unit is connected to the battery, the second input end is connected to the wireless charging unit, and the output end is respectively connected to the power supply ends of the signal processing unit, the analog-to-digital conversion unit, and the wireless transmission unit. The wireless charging unit includes a wireless charging module and a charging coil. Among them, the signal processing unit, the analog-to-digital conversion unit, the wireless transmission unit, the power management unit, and the wireless charging module constitute the circuit board part (i.e., Figure 1A and Figure 1B2 in the figure).

[0051] The signal processing unit is used to amplify and filter the electromyographic signals collected by the electrodes and then output them to the digital-to-analog conversion unit.

[0052] The digital-to-analog conversion unit is used to sample the input analog electromyographic signal and convert it into a digital electromyographic signal and output it to the wireless transmission unit.

[0053] The wireless transmission unit is used to wirelessly transmit the digital electromyographic signal to realize wireless communication with the host computer. The wireless transmission unit can be realized by using a Bluetooth chip.

[0054] The power management unit is connected to the battery and the wireless charging unit, and is used to provide working power for the signal processing unit, the digital-to-analog conversion unit, and the wireless transmission unit. The working power is usually 3.3 V. At the same time, the wireless charging unit charges the battery through the power management unit, and the power management unit protects the battery from overcharging or over-discharging.

[0055] The wireless charging unit includes a wireless charging module and a charging coil, wherein the wireless charging module is connected to the charging coil. The charging coil is used to receive the charging magnetic field energy and convert it into a charging current and output it to the wireless charging module; the wireless charging module is used to convert the charging current into a DC current and then charge the battery through the power management unit. The charging voltage is about 4.2V.

[0056] Since the circuit board, charging coil and battery need to be fixed on the irregular curved surface of the mandibular teeth of the wearable braces, the circuit board structure needs to have a certain degree of flexibility. Therefore, the circuit board part of the electromyography acquisition circuit in the embodiment of the utility model is manufactured by a flexible printed circuit board (Flexible Printed Circuit Board, referred to as FPCB) process, and the electronic components therein are connected to the circuit board through a surface mounting process or a welding process. The circuit board can be bent for easy fixed installation on the braces. Figure 4 In one embodiment shown, the overall length of the circuit board design is about 90 mm, the width is about 10 mm, and it is divided into three rectangular areas. The rounded rectangular areas on both sides are used to place electronic components such as chips, resistors and capacitors, and the middle rectangular area is used to be fixedly connected to the electrodes. The rounded rectangular areas on both sides and the middle rectangular area are connected by serpentine wires, so that the circuit board has a certain degree of stretchability, which is better suitable for the dental curves of different people and has a certain degree of versatility. The rounded rectangles on both sides of the circuit board are fixed to the buccal side of the molars of the braces, and the middle rectangle is fixed to the labial side of the incisors of the braces.

[0057] The battery uses a rechargeable polymer lithium-ion battery, which provides the working power supply for the myoelectric signal acquisition circuit and can be wirelessly charged. Further, a flexible battery is adopted to enable bendable installation. The length of the battery is about 20 mm, and the width is about 10 mm. Its capacity can support the myoelectric signal acquisition circuit to work continuously for more than 8 hours to achieve all-night sleep monitoring.

[0058] As Figure 5 shown, after the electrodes ( Figure 5 the ground electrode in is not shown), the circuit board, the battery, and the charging coil are fixedly assembled with the dental brace as the carrier, the whole needs to be waterproof encapsulated to ensure normal operation in the wet environment in the oral cavity. Since the myoelectric signal acquisition circuit in the embodiment of the present invention adopts a wireless charging and wireless signal transmission method, it avoids the exposure of the charging wire or transmission line interface, which not only meets the comfort of wearing the dental brace, but also meets the requirements of good overall waterproof enclosure.

[0059] The waterproof encapsulation adopts a two-layer film covering process. First, the electrodes, the circuit board, the battery, and the charging coil are fixed and sealed by coating food-grade silica gel around the wearable dental brace. Then, a food-grade plastic film (such as EVA, TPU, etc.) is used to cover and seal the whole wearable dental brace through a dental laminating machine. The edge of the food-grade plastic film and the wearable dental brace is adhesively sealed by food-grade silica gel to achieve overall waterproof encapsulation. The thickness of the food-grade plastic film is about 0.1 mm, which will not have too much impact on the thickness of the device so as not to affect the wearing comfort.

[0060] In an embodiment of the present invention, the host computer performs wireless communication with the wireless transmission unit in the myoelectric signal acquisition circuit, receives the acquired myoelectric signal data in real time, and performs relevant calculations, data storage, and display. The hardware part of the host computer can be implemented by a PC, a mobile phone, a tablet, or other electronic devices with wireless communication modules such as Bluetooth and ZigBee; the software part of the host computer can be written in programming languages such as C and Python to implement wireless communication functions, digital processing functions, and graphical user interface display functions.

[0061] The host computer first performs digital filtering on the original myoelectric signal, and then calculates the root mean square value of the myoelectric signal after digital filtering to reflect the energy change of muscle activity. The host computer can obtain the maximum root mean square value of the myoelectric signal generated by the user under test actions such as the tongue pressing against the palate, and use it to normalize the root mean square value of the myoelectric signal to obtain the percentage maximum myoelectric value to reflect the relative energy change of myoelectric activity. The host computer can store and analyze the acquired original myoelectric signal, the filtered myoelectric signal, and the calculated root mean square value, and obtain the percentage maximum myoelectric values of different components of the genioglossus myoelectric signal in the awake and sleep states of the user, including phasic components and tonic components, as well as the change values from the awake state to the sleep state.

[0062] In an embodiment of the present utility model, the results of collecting the myoelectric signals of a subject using this myoelectric acquisition device are as follows Figure 6 shown Figure 6 From left to right, they respectively correspond to the genioglossus myoelectric signals (EMG) when the subject continuously repeats the actions of pressing the tongue against the palate, swallowing, and protruding the tongue three times, as well as the root mean square (RMS) values calculated by the host computer. It can be seen that this myoelectric acquisition device can accurately collect the activity signals of the genioglossus muscle, and has good repeatability and discrimination for the activity signals under different actions.

[0063] Based on the above wireless intraoral genioglossus myoelectric acquisition device, an embodiment of the present utility model further provides a closed-loop functional electrical stimulation system. As Figure 7 shown, in addition to including this myoelectric acquisition device, this closed-loop functional electrical stimulation system further includes an electrical stimulation module and a control module. Among them, the electrical stimulation module is responsible for generating an electrical stimulation signal according to the control signal of the host computer. It includes a stimulation circuit, which can be integrated on the myoelectric acquisition circuit. After receiving the control signal of the control module, it generates an electrical stimulation signal according to the set stimulation intensity, frequency, pulse width, and mode. The electrical stimulation module can work in a constant voltage or constant current mode to adapt to different treatment requirements. The control module is the intelligent decision-making unit in the closed-loop functional electrical stimulation system. It performs real-time analysis on the received myoelectric signals and generates control signals according to the analysis results. The control module can adopt methods such as threshold detection, template comparison, or machine learning models to achieve precise evaluation of the myoelectric signals and determine whether electrical stimulation needs to be applied and the specific parameters of the stimulation. It should be noted that the control module can be completely implemented by an independent microcontroller (MCU). In this way, the microcontroller will directly receive the signals from the myoelectric acquisition device, perform necessary processing and analysis, and independently generate control signals according to the analysis results to adjust the working parameters of the electrical stimulation module. In another implementation manner, the function of the control module can be undertaken by the host computer. In this case, the host computer will execute the tasks of the control module, including signal reception, processing, analysis, and generation of control signals.

[0064] In the closed-loop functional electrical stimulation system provided by the embodiment of the present utility model, this myoelectric acquisition device is the basis, and the myoelectric signals collected by it are used as feedback signals to start the entire closed-loop control process. First, the myoelectric acquisition device wirelessly sends the captured myoelectric signals to the host computer through its built-in wireless transmission unit. After receiving these data, the host computer not only performs real-time display and storage, but also deeply analyzes the signals, extracts key parameters, such as the root mean square value of the myoelectric, etc., to evaluate the activity state of the genioglossus muscle.

[0065] The analysis results are then transmitted to the control module, which uses this information to make intelligent decisions and generate corresponding control signals. These signals direct the electrical stimulation module to adjust its output parameters, such as stimulation intensity, frequency, pulse width, and mode, to adapt to the current electromyogram signal characteristics. After receiving the control signals, the electrical stimulation module applies customized electrical stimulation to the genioglossus muscle through electrodes, aiming to enhance muscle activity, maintain airway patency, and prevent the occurrence of obstructive sleep apnea (OSA).

[0066] After applying the electrical stimulation, the closed-loop functional electrical stimulation system enters the data acquisition phase again. The electromyogram acquisition device captures new electromyogram signals to form a closed-loop feedback. The host computer and the control module re-analyze these signals, evaluate the effect of the electrical stimulation, and further adjust the stimulation parameters if necessary to achieve dynamic optimization of the treatment process. This closed-loop working mode ensures the real-time and adaptability of the treatment, improves the effectiveness of the treatment and the user's comfort, and at the same time ensures the safety of the treatment process.

[0067] Compared with the prior art, the wireless intraoral genioglossus electromyogram acquisition device provided by the embodiment of the present utility model effectively improves the accuracy of the acquired signals and the user's wearing comfort by fixedly assembling the electrode, the electromyogram acquisition circuit and the wearable dental appliance and performing waterproof encapsulation, as well as cooperating with the technical solutions of wireless transmission and wireless charging, making it suitable for long-term wearing in the moist oral environment. The corresponding closed-loop functional electrical stimulation system integrates electromyogram signal monitoring and electrical stimulation, can monitor the activity state of the genioglossus muscle in real time, and provide electrical stimulation when necessary to maintain airway patency and effectively prevent respiratory problems caused by airway collapse. The system can also automatically adjust the stimulation parameters according to the real-time feedback of the electromyogram signal, improving the accuracy and efficacy of the treatment, and is particularly suitable for treating obstructive sleep apnea (OSA).

[0068] It should be noted that the orientation or positional relationship indicated by terms such as "thickness", "upper", "lower", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as a limitation to the present utility model.

[0069] The above has provided a detailed description of the wireless intraoral genioglossus electromyogram acquisition device and its functional electrical stimulation system provided by the present utility model. For those of ordinary skill in the art, any obvious changes made without departing from the essence of the present utility model will constitute an infringement of the patent right of the present utility model and will bear corresponding legal responsibilities.

Claims

1. A wireless intraoral genioglossus electromyogram acquisition device, characterized in that It includes a wearable dental appliance, electrodes, and an electromyogram acquisition circuit; among them, the electromyogram acquisition circuit is connected to the electrodes, and both the electromyogram acquisition circuit and the electrodes are fixedly installed on the wearable dental appliance and integrally waterproof packaged to form a whole, and are worn on the lower jaw teeth in the oral cavity for meshing with the teeth during use; the wearable dental appliance is used as a carrier for fixedly installing the electromyogram acquisition circuit and the electrodes; the electrodes include two acquisition electrodes and a ground electrode, which are used to collect the electrophysiological activity signals of the genioglossus muscle in real time; the electromyogram acquisition circuit is used to convert and process the electromyogram signals of the genioglossus muscle collected by the electrodes and then send them to the host computer.

2. The wireless intraoral genioglossus electromyogram acquisition device according to claim 1, wherein: the wearable dental appliance is prepared according to the user's lower jaw tooth model by using a formed transparent film through a dental laminating machine; or, it is prepared by using a thermoplastic dental appliance that becomes soft in hot water and is bite-molded by the user.

3. The wireless intraoral genioglossus electromyogram acquisition device according to claim 1, wherein: the electrodes are made of titanium metal, the acquisition end is spherical, the end is an electrode wire, and after drilling holes in the spherical acquisition end, the connection with the electrode wire is realized by interference fit.

4. The wireless intraoral genioglossus electromyogram acquisition device according to claim 1, wherein: the two acquisition electrodes are positioned at the gap between the canine and lateral incisor teeth of the lower jaw of the wearable dental appliance, and the ground electrode is positioned at the midline of the lower front teeth of the wearable dental appliance, and are respectively fixed to the inner and outer sides of the wearable dental appliance.

5. The wireless intraoral genioglossus electromyogram acquisition device according to claim 4, wherein: the spherical acquisition end of the acquisition electrode is in contact with the genioglossus muscle bulge, the spherical acquisition end of the ground electrode is in contact with the labial gingiva below the midline of the lower front teeth, and the ends of the electrodes are all connected to the electromyogram acquisition circuit.

6. The wireless intraoral genioglossus electromyogram acquisition device according to claim 1, wherein: the electromyogram acquisition circuit includes a signal processing unit, an analog-to-digital conversion unit, a wireless transmission unit, a power management unit, a wireless charging unit, and a battery; among them, the input end of the signal processing unit is connected to the electrodes, and the input and output ends of the signal processing unit, the analog-to-digital conversion unit, and the wireless transmission unit are connected in sequence; the first input end of the power management unit is connected to the battery, the second input end is connected to the wireless charging unit, and the output end is respectively connected to the power supply ends of the signal processing unit, the analog-to-digital conversion unit, and the wireless transmission unit; the signal processing unit is used to amplify and filter the electromyogram signals collected by the electrodes and then output them to the analog-to-digital conversion unit; the analog-to-digital conversion unit is used to sample the input analog electromyogram signals and then convert them into digital electromyogram signals and output them to the wireless transmission unit; the wireless transmission unit is used to send the digital electromyogram signals to realize wireless communication with the host computer. The power management unit is used to provide operating power for the signal processing unit, the digital-to-analog conversion unit, and the wireless transmission unit. Meanwhile, the wireless charging unit charges the battery through the power management unit.

7. The wireless intraoral genioglossus electromyogram acquisition device according to claim 1, wherein: The circuit board part in the electromyogram acquisition circuit is fabricated using flexible printed circuit board technology; wherein, The circuit board is divided into three rectangular regions. The rectangular regions on both sides are used to place chips and electronic components, and the rectangular region in the middle is used to be fixedly connected to the electrode. The three rectangular regions are connected by serpentine wires to achieve the stretchability of the circuit board; The rectangular regions on both sides of the circuit board are fixed to the buccal side of the molars of the wearable dental appliance, and the rectangular region in the middle is fixed to the labial side of the incisors of the wearable dental appliance.

8. The wireless intraoral genioglossus electromyogram acquisition device according to claim 1, wherein: The wearable dental appliance is encapsulated using a double-lamination process; wherein, the electrode, the circuit board, the battery, and the charging coil are first fixed and sealed by coating food-grade silicone around the wearable dental appliance, and then the entire wearable dental appliance is covered and sealed with a food-grade plastic film through a dental laminating machine. The edges of the food-grade plastic film and the wearable dental appliance are adhesively sealed with food-grade silicone to achieve overall waterproof encapsulation.

9. The wireless submental mylohyoid muscle EMG acquisition device according to claim 1, characterized in that It further includes a host computer; The host computer is used to receive the genioglossus electromyogram signal data in real time and perform relevant calculations, data storage, and display.

10. A closed-loop functional electrical stimulation system, comprising the wireless intraoral genioglossus electromyogram acquisition device according to any one of claims 1 to 9, characterized in that It further includes an electrical stimulation module and a control module; wherein, The wireless intraoral genioglossus electromyogram acquisition device sends the acquired electromyogram signal to the host computer, the host computer transmits the analysis result to the control module, and the control module makes an intelligent decision to generate a control signal; after receiving the control signal, the electrical stimulation module applies a customized electrical stimulation to the genioglossus muscle through the electrode; After applying the electrical stimulation, the wireless intraoral genioglossus electromyogram acquisition device captures new electromyogram signals to form a closed-loop feedback.

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