Wireless intraoral genioglossus electromyography collection apparatus and functional electrical stimulation system thereof

Abstract

A wireless intraoral genioglossus electromyography collection apparatus, and a closed-loop functional electrical stimulation system comprising the apparatus. In the electromyography collection apparatus, electrodes (5, 50), electromyography collection circuits (2, 3, 4) and a wearable dental appliance (1) are fixedly assembled and are subject to waterproof packaging, so that the accuracy of signal collection and the wearing comfort of a user are effectively improved, and the apparatus is suitable for being worn for a long time in an intraoral humid environment. The closed-loop functional electrical stimulation system integrates electromyographic signal monitoring and electrical stimulation, can monitor the activity state of the genioglossus in real time, and provides electrical stimulation when necessary to maintain airway patency, and thus effectively prevents breathing problems caused by airway collapse. The system can also automatically adjust stimulation parameters according to real-time feedback of electromyographic signals, such that the treatment accuracy and the treatment effect are improved, and the system is particularly suitable for treating obstructive sleep apnea.

Description

A wireless intraoral genioglossus muscle electromyography acquisition device and its functional electrical stimulation system Technical Field

[0001] The present invention relates to a wireless intraoral genioglossus myoelectric acquisition device and also to a closed-loop functional electrical stimulation system using the myoelectric acquisition device, belonging to the technical field of medical devices. Background Art

[0002] Obstructive sleep apnea (OSA) is a common sleep disorder associated with a variety of chronic conditions, including coronary heart disease, hypertension, arrhythmias, type 2 diabetes, cerebrovascular disease, and cognitive impairment. OSA patients often experience sleep disruption and apnea at night, leading to daytime sleepiness and an increased risk of traffic accidents. This issue has attracted significant medical attention due to its significant health and societal impacts.

[0003] The pathogenesis of obstructive sleep apnea (OSA) involves multiple physiological factors, particularly dysfunction of the neuromuscular upper airway dilator muscles, which play a key role in maintaining airway patency during sleep. Dysfunction of the genioglossus, the primary upper airway dilator, can lead to airway collapse and apnea. Therefore, monitoring genioglossus activity is crucial for the diagnosis and treatment of OSA.

[0004] Currently, genioglossus electromyography (GGEMG) is the primary method for monitoring genioglossus muscle activity. Traditional methods for acquiring electromyographic signals include invasive needle electrodes and non-invasive surface electrodes. Although invasive methods are accurate, they are not suitable for long-term monitoring, while non-invasive extraoral surface electrodes are convenient but have limited accuracy. Intraoral surface electrodes provide a more accurate monitoring method, but existing technologies still need improvement because they usually require the electrode wires to be led from inside the mouth to outside the mouth, which affects the user's comfort and the natural closure of the mouth.

[0005] On the other hand, Chinese invention patent number ZL 201210592267.5 discloses a non-invasive transcutaneous variable frequency electrical stimulation multifunctional respiratory therapy device, comprising a real-time respiratory monitoring module for monitoring the respiratory status of a monitored subject in real time while they are asleep and obtaining sleep parameters; an electrical stimulation signal generating module for providing at least two electrical stimulation modes; and non-implantable transcutaneous electrodes for transmitting the chronic variable frequency electrical stimulation signal to the monitored subject's diaphragm or genioglossus muscle; or transmitting the acute electrical stimulation signal to the monitored subject's diaphragm or genioglossus muscle. This device integrates multiple functions, including acute diaphragm pacing, chronic variable frequency diaphragm electrical stimulation, acute genioglossus electrical stimulation, and variable frequency genioglossus electrical stimulation. It can terminate apnea and reverse hypoxia through acute electrical stimulation, and improve the contractility and fatigue resistance of the diaphragm and genioglossus muscles through variable frequency electrical stimulation, thus providing both therapeutic and preventive benefits. However, there are still some areas that need further improvement in this therapeutic device, including: the comfort of long-term wearing and user compliance need to be improved; the personalization and adaptability of electrical stimulation need to be adjusted according to the specific situation of the user, etc. Summary of the Invention

[0006] The primary technical problem to be solved by the present invention is to provide a wireless intraoral genioglossus muscle electromyography acquisition device.

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

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

[0009] According to a first aspect of an embodiment of the present invention, a wireless intraoral genioglossus myoelectric acquisition device is provided, comprising a wearable brace, electrodes, and an electromyographic acquisition circuit; wherein:

[0010] The myoelectric acquisition circuit is connected to the electrodes, and the myoelectric acquisition circuit and the electrodes are fixedly mounted on the wearable mouth guard and are integrally formed after being waterproofly packaged as a whole. When in use, the wearable mouth guard is worn on the mandibular teeth in the oral cavity and meshes with the teeth;

[0011] The wearable braces are used as a carrier to fix the myoelectric acquisition circuit and the electrodes;

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

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

[0014] Preferably, the wearable braces are prepared by forming a transparent film using a dental laminator according to the user's mandibular tooth model; or, they are prepared by softening a thermoplastic brace in hot water and then having the user bite down to form the brace.

[0015] Preferably, the electrode is made of titanium metal, the collecting end is spherical, and the end is an electrode wire. After a hole is punched in the spherical collecting end, the electrode wire is connected with the collecting end by interference fit.

[0016] Preferably, the two collection electrodes are positioned at the gap between the mandibular canines and lateral incisors of the wearable braces, and the ground electrode is positioned at the middle gap of the lower incisors of the wearable braces, and are fixed to the inner and outer sides of the wearable braces respectively.

[0017] Preferably, the spherical collecting end of the collecting electrode contacts the genioglossus muscle protuberance, the spherical collecting end of the grounding electrode contacts the labial gum below the middle suture of the lower incisors, and the ends of the electrodes are connected to the myoelectric collecting circuit.

[0018] Preferably, the electromyography acquisition circuit includes a signal processing unit, a digital-to-analog 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 digital-to-analog conversion unit, and the wireless transmission unit are connected in sequence;

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

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

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

[0023] The wireless transmission unit is used to send the digital electromyographic 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 digital-to-analog 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 of the electromyography acquisition circuit is manufactured using a flexible printed circuit board process; 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. The middle rectangular area is used to be fixedly connected to 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 to the buccal sides of the molars of the wearable braces, and the middle rectangular area is fixed to the labial side of the incisors of the wearable braces.

[0028] Preferably, the wearable braces are packaged using a secondary lamination process; wherein the electrodes, circuit board, battery, and charging coil are first coated around the wearable braces with food-grade silicone for fixation and sealing, and then the entire wearable braces are covered and sealed with a food-grade plastic film using a dental laminator, and the edges of the food-grade plastic film and the wearable braces are bonded and sealed with food-grade silicone to achieve overall waterproof packaging.

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

[0030] The wireless intraoral genioglossus muscle electromyography acquisition device sends the collected electromyographic signals to a host computer, which transmits the analysis results to the control module. The control module makes an intelligent decision and generates a control signal. After receiving the control signal, the electrical stimulation module applies customized electrical stimulation to the genioglossus muscle through electrodes.

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

[0032] Compared with the prior art, the wireless intraoral genioglossus muscle electromyography acquisition device provided in the embodiment of the present invention effectively improves the accuracy of the acquired signal and the comfort of the user by fixing and assembling the electrodes, electromyography acquisition circuit and wearable braces and waterproof packaging, and cooperates with the technical solutions of wireless transmission and wireless charging, making it suitable for long-term wear in a moist oral environment. The corresponding closed-loop functional electrical stimulation system integrates electromyography signal monitoring and electrical stimulation, which can monitor the activity status 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 electromyography signal, thereby improving the accuracy and efficacy of the treatment, and is particularly suitable for the treatment of obstructive sleep apnea (OSA). BRIEF DESCRIPTION OF THE DRAWINGS

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

[0034] FIG2 is a schematic diagram of the structure and installation process of the electrode in an embodiment of the present invention;

[0035] FIG3 is a block diagram of a myoelectric acquisition circuit according to an embodiment of the present invention;

[0036] FIG4 is an exemplary diagram of a circuit board in a bent state according to an embodiment of the present invention;

[0037] FIG5 is a schematic diagram of the outer shape design of a circuit board in an embodiment of the present invention;

[0038] FIG6 is a schematic diagram of a circuit board in different stretched states according to an embodiment of the present invention;

[0039] FIG7 is an exploded view of the overall structure of the electromyographic acquisition device in an embodiment of the present invention.

[0040] FIG8 is a schematic diagram of myoelectric signals collected by a wireless intraoral genioglossus myoelectric acquisition device in an embodiment of the present invention;

[0041] FIG9 is a schematic structural diagram of a closed-loop functional electrical stimulation system provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0042] The technical content of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0043] As shown in Figures 1A and 1B, a wireless intraoral genioglossus muscle myoelectric acquisition device (abbreviated as an EMG acquisition device) provided by an embodiment of the present invention includes a wearable mouthguard 1, electrodes 5 and 50, EMG acquisition circuits 2, 3, and 4, and a host computer (not shown). The EMG acquisition circuit is connected to the electrodes, and both the EMG acquisition circuit and the electrodes are fixedly mounted on the wearable mouthguard and waterproofly packaged to form an integrated unit. When in use, the wearable mouthguard is worn on the mandibular teeth in the mouth to engage with the teeth.

[0044] Wearable mouthguards are specialized for myoelectric acquisition. They serve as a carrier for mounting myoelectric acquisition circuits and electrodes. They are worn on the user's mandibular teeth and mesh with the teeth.

[0045] The electrodes include two acquisition electrodes 5 and a ground electrode 50, which are used to collect the electrophysiological activity signals of the genioglossus muscle in real time. When in use, the two acquisition electrodes are extended to the floor of the mouth and contact the genioglossus muscle protuberance, and the ground electrode contacts the labial gum below the middle seam of the lower incisors.

[0046] The myoelectric acquisition circuit is used to convert and process the myoelectric signals of the genioglossus muscle collected by the electrodes and then send them to the host computer. It specifically includes a circuit board 2, a battery 3 and a charging coil 4.

[0047] The host computer is used to receive the genioglossus muscle electromyographic signal data in real time and perform relevant calculations, data storage and display.

[0048] In one embodiment of the present invention, in order to ensure the comfort and reliability of the wearable braces when worn, the braces need 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 it can be obtained by obtaining a digital model through an intraoral scanner and then 3D printing. The braces are made of a molded transparent film with a thickness of no more than 1 mm. The film has good wearing comfort and can reduce the user's foreign body sensation. The braces are then molded and prepared using a dental laminator. In addition, in order to improve the convenience of use, in another embodiment of the present invention, the braces can be replaced by thermoplastic braces. After the thermoplastic braces are softened in hot water and placed in the user's mouth for biting, they can be molded into braces that fit the user's mandibular teeth, which are convenient and quick to use.

[0049] In one embodiment of the present invention, as shown in Figure 2, the electrode's collection end is spherical with a diameter of 3 mm. This spherical collection end is connected to an electrode wire with a diameter of 0.6 mm. Both are made of biocompatible titanium. To connect the spherical collection end to the electrode wire, a hole is first drilled in the spherical collection end, and the electrode wire is inserted into the hole. The two are connected using an interference fit, and the electrode wire is then insulated and encapsulated with heat shrink tubing. Because the electrode wire is relatively rigid and malleable, its position within the mouth can be easily adjusted. Two collection electrodes are positioned between the canine and lateral incisor of the mandibular brace and secured to the inner and outer surfaces of the brace, respectively. The spacing between the two collection electrodes is approximately 10 to 15 mm, adjustable via the electrode wire. The collection electrodes extend approximately 35 mm downward from the upper edge of the tooth crown. The spherical collection end of the collection electrode contacts the genioglossus muscle protuberance, and the other end of the electrode wire is connected to the myoelectric acquisition circuit via a plug-in connector. The ground electrode 50 is positioned at the middle seam of the lower incisors of the wearable braces, and its spherical collection end contacts the labial gum below the middle seam of the lower incisors. The ground electrode extends downward from the upper edge of the crown by about 20 mm, and the other end of the electrode wire is connected to the myoelectric acquisition circuit through a plug-in.

[0050] 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 silver, silver chloride or other conductive materials such as conductive hydrogel and conductive polymer to realize the collection of the electromyographic signal of the genioglossus muscle.

[0051] In terms of electrode material selection, traditional silver or silver chloride electrodes are widely used for surface electrophysiological signal acquisition due to their stable electrochemical properties and accurate signal recording. However, their poor biocompatibility in intraoral settings cannot be ignored. Electrode materials such as gels and conductive pastes are wet electrodes, and their performance deteriorates over time due to gradual drying. Titanium, a metal material with excellent biocompatibility, offers advantages in safety and stability. However, titanium suffers from poor welding properties, making it difficult to electrically connect the spherical acquisition end to the electrode wire via soldering. Therefore, embodiments of the present invention propose a titanium electrode preparation process based on an interference fit, connecting a plastic titanium wire to a titanium sphere with a hole of the same size, thus addressing the difficulty of welding micro-scale titanium. Specifically, the electrode consists of two parts: a spherical electrode (titanium sphere) and an electrode wire (titanium wire). The diameter of the spherical electrode is approximately 3 mm, while the diameter of the electrode wire is approximately 0.6 mm. During the preparation process, a titanium sphere with a hole of the same diameter as the electrode wire is first prepared. The titanium wire is then inserted into this hole. The so-called interference fit refers to inserting one component (here the electrode wire) into the hole of another component (here the spherical electrode), and through a certain amount of pressure or heat treatment, making the two fit tightly together to form a whole. This way of fitting does not require welding, thus solving the problem of difficult welding of micro-scale titanium metal. After the electrode wire is inserted into the hole of the spherical electrode, it is fixed by 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 will be insulated and packaged with heat shrink tubing to prevent current leakage or other electrical problems. The prepared electrode will be positioned in the gap between the canine and lateral incisor of the mandibular braces and fixed to the inner and outer sides of the braces. This design is to ensure that the electrode can accurately contact the genioglossus muscle protuberance, thereby effectively collecting electromyographic signals.

[0052] In one embodiment of the present invention, as shown in FIG3 , the electromyography acquisition circuit includes a signal processing unit, a digital-to-analog conversion unit, a wireless transmission unit, a power management unit, a wireless charging unit, and a battery. 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 digital-to-analog 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 connected to the power supply end of the signal processing unit, the digital-to-analog conversion unit, and the wireless transmission unit, respectively. The wireless charging unit includes a wireless charging module and a charging coil. The signal processing unit, the digital-to-analog conversion unit, the wireless transmission unit, the power management unit, and the wireless charging module constitute a circuit board portion (as shown by reference numeral 2 in FIG1A and FIG1B ).

[0053] 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.

[0054] The digital-to-analog conversion unit is used to sample the input analog electromyographic signal and convert it into a digital electromyographic signal to output to the wireless transmission unit.

[0055] The wireless transmission unit is used to wirelessly transmit digital electromyographic signals to achieve wireless communication with the host computer. The wireless transmission unit can be implemented using a Bluetooth chip.

[0056] The power management unit (PMU) is connected to the battery and wireless charging unit, providing operating power (typically 3.3V) to the signal processing unit, digital-to-analog conversion unit, and wireless transmission unit. The wireless charging unit also charges the battery through the PMU, which protects the battery from overcharging or over-discharging.

[0057] The wireless charging unit includes a wireless charging module and a charging coil. The wireless charging module is connected to the charging coil. The charging coil receives the charging magnetic field energy and converts it into charging current, which is then output to the wireless charging module. The wireless charging module converts the charging current into DC current, which is then used by the power management unit to charge the battery. The charging voltage is approximately 4.2V.

[0058] 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 electromyographic acquisition circuit in the embodiment of the present invention is manufactured by a flexible printed circuit board (FPCB) process, and the electronic components therein are connected to the circuit board by a surface mounting process or a welding process. As shown in Figure 4, the circuit board can be bent to facilitate fixed installation on the braces. In an embodiment shown in Figure 5, the overall length of the circuit board design is about 90mm and the width is about 10mm. 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 for fixed connection with the electrodes. The rounded rectangular areas on both sides and the middle rectangular area are connected by serpentine wires, as shown in Figure 6, so that the circuit board has a certain degree of stretchability, which is better adapted to 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.

[0059] The battery uses a rechargeable polymer lithium-ion battery to power the EMG acquisition circuit and can be wirelessly charged. Furthermore, the battery is flexible, allowing for flexible installation. The battery is approximately 20mm long and 10mm wide, and its capacity can support the EMG acquisition circuit for over eight hours of continuous operation, enabling all-night sleep monitoring.

[0060] As shown in Figure 7 , after the electrodes (the ground electrode in Figure 7 is not shown), circuit board, battery, and charging coil are fixedly assembled with the braces as a carrier, they need to be waterproofed to ensure normal operation in the wet environment of the oral cavity. Because the myoelectric acquisition circuit in this embodiment of the present invention uses wireless charging and wireless signal transmission, the charging cable or transmission cable interface is avoided from being exposed, which not only meets the comfort of wearing the braces, but also meets the requirements of good overall waterproof sealing.

[0061] The waterproof package is achieved through a secondary lamination process. The electrodes, circuit board, battery, and charging coil are first coated with food-grade silicone around the wearable brace for securement and sealing. Next, a food-grade plastic film (EVA, TPU, etc.) is applied using a dental laminator to seal the entire wearable brace. The edges of the food-grade plastic film and the wearable brace are bonded and sealed with food-grade silicone to achieve a fully waterproof package. The food-grade plastic film is approximately 0.1mm thick, which does not significantly affect the thickness of the device, thereby preventing it from compromising wearer comfort.

[0062] In one embodiment of the present invention, a host computer wirelessly communicates with a wireless transmission unit in the electromyography (EMG) acquisition circuit, receives collected EMG signal data in real time, and performs relevant calculations, data storage, and display. The host computer's hardware can be implemented using a PC, mobile phone, tablet, or other electronic device with a wireless communication module such as Bluetooth or ZigBee. The host computer's software can be written in a programming language such as C or Python, implementing wireless communication, digital processing, and a graphical user interface (GUI) display.

[0063] The host computer first digitally filters the raw EMG signal and then calculates the RMS value of the filtered signal to reflect the energy changes in muscle activity. The host computer can obtain the maximum RMS value generated by the user during test movements such as tongue thrusting and palate pressing. This is used to normalize the RMS value to obtain the percent maximum EMG value, reflecting the relative energy changes in EMG activity. The host computer can store and analyze the collected raw EMG signal, the filtered EMG signal, and the calculated RMS value to obtain the percent maximum EMG values ​​for different components of the genioglossus muscle during wakefulness and sleep, including phasic and tonic components, as well as the change from wakefulness to sleep.

[0064] In one embodiment of the present invention, the results of myoelectric signal acquisition using this EMG acquisition device on a subject are shown in Figure 8. Figure 8 shows, from left to right, the EMG signals of the genioglossus muscle, as the subject repeatedly performed three consecutive actions of tongue thrusting against the palate, swallowing, and tongue extension, along with the root mean square (RMS) values ​​calculated by the host computer. This demonstrates that the EMG acquisition device can accurately capture genioglossus muscle activity signals, with good repeatability and discrimination between activity signals under different actions.

[0065] Based on the aforementioned wireless intraoral genioglossus muscle EMG acquisition device, embodiments of the present invention further provide a closed-loop functional electrical stimulation system. As shown in Figure 9, in addition to the EMG acquisition device, the closed-loop functional electrical stimulation system also includes an electrical stimulation module and a control module. The electrical stimulation module is responsible for generating electrical stimulation signals based on control signals from a host computer. It includes a stimulation circuit that can be integrated with the EMG acquisition circuit. After receiving control signals from the control module, it generates electrical stimulation signals according to the set stimulation intensity, frequency, pulse width, and pattern. The electrical stimulation module can operate in either a constant voltage or constant current mode to accommodate different treatment needs. The control module is the intelligent decision-making unit in the closed-loop functional electrical stimulation system, performing real-time analysis of received EMG signals and generating control signals based on the analysis results. The control module can employ methods such as threshold detection, template comparison, or machine learning models to accurately evaluate EMG signals and determine whether electrical stimulation is necessary and the specific stimulation parameters. It should be noted that the control module can be fully implemented by a standalone microcontroller (MCU). In this approach, the microcontroller directly receives signals from the electromyographic acquisition device, performs necessary processing and analysis, and independently generates control signals based on the analysis results to adjust the operating parameters of the electrical stimulation module. In another implementation, the functions of the control module can be assumed by the host computer. In this case, the host computer will perform the tasks of the control module, including signal reception, processing, analysis, and generation of control signals.

[0066] In the closed-loop functional electrical stimulation system provided by an embodiment of the present invention, the myoelectric acquisition device is fundamental. The collected myoelectric signals serve as feedback signals to initiate the entire closed-loop control process. First, the myoelectric acquisition device wirelessly transmits the captured myoelectric signals to a host computer via its built-in wireless transmission unit. After receiving this data, the host computer not only displays and stores it in real time but also conducts in-depth signal analysis, extracting key parameters such as the root mean square value of the myoelectricity to assess the activity status of the genioglossus muscle.

[0067] The analysis results are then transmitted to the control module, which uses this information to make intelligent decisions and generate appropriate control signals. These signals guide the electrical stimulation module, adjusting its output parameters, such as stimulation intensity, frequency, pulse width, and pattern, to suit the current EMG signal characteristics. After receiving the control signals, the electrical stimulation module applies customized electrical stimulation to the genioglossus muscle via electrodes, aiming to enhance muscle activity, maintain airway patency, and prevent the occurrence of obstructive sleep apnea (OSA).

[0068] After electrical stimulation is applied, the closed-loop functional electrical stimulation system enters the data acquisition phase again. The EMG acquisition device captures new EMG signals, forming a closed-loop feedback loop. The host computer and control module reanalyze these signals, evaluate the effectiveness of the electrical stimulation, and, if necessary, further adjust the stimulation parameters to dynamically optimize the treatment process. This closed-loop operation ensures real-time and adaptable treatment, improving treatment effectiveness and user comfort while ensuring safety during the treatment process.

[0069] Compared with the prior art, the wireless intraoral genioglossus muscle electromyography acquisition device provided in the embodiment of the present invention effectively improves the accuracy of the acquired signal and the comfort of the user by fixing and assembling the electrodes, electromyography acquisition circuit and wearable braces and waterproof packaging, and cooperates with the technical solutions of wireless transmission and wireless charging, making it suitable for long-term wear in a moist oral environment. The corresponding closed-loop functional electrical stimulation system integrates electromyography signal monitoring and electrical stimulation, which can monitor the activity status 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 electromyography signal, thereby improving the accuracy and efficacy of the treatment, and is particularly suitable for the treatment of obstructive sleep apnea (OSA).

[0070] It should be noted that the orientation or positional relationship indicated by the terms "thickness", "upper" and "lower" are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it cannot be understood as a limitation on the present invention.

[0071] The wireless intraoral genioglossus muscle electromyography acquisition device and its functional electrical stimulation system provided by the present invention have been described in detail above. For those skilled in the art, any obvious modification thereof without departing from the essence of the present invention would constitute an infringement of the present invention's patent rights and would incur corresponding legal liability.

Claims

1. A wireless intraoral genioglossus muscle electromyography acquisition device, characterized in that It includes wearable braces, electrodes, and myoelectric acquisition circuits; among which, The myoelectric acquisition circuit is connected to the electrode, and the myoelectric acquisition circuit and the electrode are fixedly mounted on the wearable mouth guard, and are integrally formed after being waterproofly packaged as a whole, and are worn on the mandibular teeth in the oral cavity to mesh with the teeth when in use; The wearable braces are used as a carrier to fix and install the electromyographic acquisition circuit and the electrodes; The electrodes include two collection electrodes and a ground electrode, which are used to collect the electrophysiological activity signals of the genioglossus muscle in real time; The electromyographic acquisition circuit is used to convert and process the electromyographic signals of the genioglossus muscle acquired by the electrodes and then send them to the host computer.

2. The wireless intraoral genioglossus electromyography acquisition device according to claim 1, characterized in that: The wearable braces are prepared by using a molded transparent film through a dental laminator according to the user's mandibular tooth model; or, they are prepared by using a thermoplastic brace that is softened in hot water and then shaped by the user's bite.

3. The wireless intraoral genioglossus electromyography acquisition device according to claim 1, characterized in that: The electrode is made of titanium metal, the collecting end is spherical, and the end is an electrode wire. After a hole is punched on the spherical collecting end, the electrode wire is connected with the collecting end by interference fit.

4. The wireless intraoral genioglossus electromyography acquisition device according to claim 1, characterized in that: The two collecting electrodes are positioned at the gap between the mandibular canines and lateral incisors of the wearable braces, and the grounding electrode is positioned at the middle gap of the lower incisors of the wearable braces, and are respectively fixed to the inner and outer sides of the wearable braces.

5. The wireless intraoral genioglossus electromyography acquisition device according to claim 4, characterized in that: The spherical collecting end of the collecting electrode contacts the genioglossus muscle protuberance, the spherical collecting end of the grounding electrode contacts the labial gums below the middle seam of the lower incisors, and the ends of the electrodes are connected to the myoelectric collecting circuit.

6. The wireless intraoral genioglossus electromyography acquisition device according to claim 1, characterized in that: The electromyography acquisition circuit includes a signal processing unit, a digital-to-analog conversion unit, a wireless transmission unit, a power management unit, a wireless charging unit and a battery; wherein, 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 digital-to-analog conversion unit and the wireless transmission unit are connected in sequence; The first input terminal of the power management unit is connected to the battery, the second input terminal is connected to the wireless charging unit, and the output terminal is respectively connected to the signal processing unit, the digital-to-analog conversion unit, and the power terminal of the wireless transmission unit; The signal processing unit is used to amplify and filter the electromyographic signal collected by the electrode and then output it to the digital-to-analog conversion unit; The digital-to-analog conversion unit is used to sample the input analog electromyographic signal and convert it into a digital electromyographic signal to output to the wireless transmission unit; The wireless transmission unit is used to send the digital electromyographic signal to achieve wireless communication with the host computer; The power management unit is used to provide working power for the signal processing unit, the digital-to-analog conversion unit and the wireless transmission unit. At the same time, the wireless charging unit charges the battery through the power management unit.

7. The wireless intraoral genioglossus electromyography acquisition device according to claim 1, characterized in that: The circuit board part in the electromyography acquisition circuit is manufactured using a flexible printed circuit board process; wherein, The circuit board is divided into three rectangular areas, the rectangular areas on both sides are used to place chips and electronic components, the middle rectangular area is used to be fixedly connected to the electrode, and the three rectangular areas are connected by serpentine wires to achieve the stretchability of the circuit board; The rectangular areas on both sides of the circuit board are fixed to the buccal side of the molars of the wearable braces, and the middle rectangular area is fixed to the labial side of the incisors of the wearable braces.

8. The wireless intraoral genioglossus electromyography acquisition device according to claim 1, characterized in that: The wearable braces are packaged using a secondary coating process; wherein the electrodes, circuit boards, batteries, and charging coils are first coated around the wearable braces with food-grade silicone for fixation and sealing, and then the entire wearable braces are covered and sealed with a food-grade plastic film using a dental laminator, and the edges of the food-grade plastic film and the wearable braces are bonded and sealed with food-grade silicone to achieve overall waterproof packaging.

9. The wireless intraoral genioglossus electromyography acquisition device according to claim 1, characterized in that It also includes the host computer; The host computer is used to receive the genioglossus muscle electromyographic 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 muscle electromyography acquisition device according to any one of claims 1 to 9, characterized in that It also includes an electrical stimulation module and a control module; wherein, The wireless intraoral genioglossus muscle electromyography acquisition device sends the collected electromyography signal to the host computer, and the host computer transmits the analysis result to the control module, and the control module makes an intelligent decision and generates a control signal; after receiving the control signal, the electrical stimulation module applies customized electrical stimulation to the genioglossus muscle through the electrode; After applying electrical stimulation, the wireless intraoral genioglossus muscle electromyography acquisition device captures new electromyography signals to form a closed-loop feedback.

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