Facial paralysis rehabilitation therapy mask integrating adjustable pulse electrical stimulation and control system

Abstract

The invention relates to the field of facial paralysis rehabilitation stimulation, and provides a facial paralysis rehabilitation treatment mask integrating adjustable pulse electrical stimulation and a control system. A flexible electrode plate group and at least two groups of acupoint targeting electrode units are arranged on the inner side of the mask body corresponding to a facial paralysis treatment acupoint area; the first electrode group corresponds to Yangbai acupoint and temple areas; the second electrode group corresponds to the area of the Dizheng point and the area of the cheek-car point; the snap-fastener type electric connection interface is arranged at the edge of the outer side of the mask and is connected with each electrode group through a wire; the micro electrical stimulation therapeutic instrument outputs an adjustable pulse electric signal to the electrode group through the button interface; the micro electrical stimulation therapeutic apparatus comprises a pulse generation module, and pulse waves comprise dense waves, sparse waves and discontinuous waves.

Description

Technical Field

[0001] The present invention relates to the field of facial paralysis rehabilitation, and in particular to a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation and a control system. Background Art

[0002] Facial paralysis (Bell's palsy) is a facial muscle movement disorder caused by facial nerve dysfunction, and its clinical manifestations include symptoms such as crooked corners of the mouth and incomplete eyelid closure. Traditional treatments mainly include oral medications (such as glucocorticoids, antiviral drugs), acupuncture and physical therapy. Among them, acupuncture stimulates the Dicang, Cheek Cartilage, Taiyang and other acupoints to dispel wind and dredge the meridians, but it relies on the operation of a physician, the treatment cycle is long and it is difficult to achieve continuous intervention; and although conventional electrical stimulators can simulate acupuncture techniques, they have problems such as inaccurate acupoint positioning, fixed stimulation parameters, and lack of personalized adaptation. Especially in the recovery period, it is difficult to achieve targeted neuromuscular function reconstruction.

[0003] In recent years, wearable medical devices have gradually been applied to the field of facial paralysis rehabilitation, such as masks with integrated heat therapy or Chinese medicine patches. In the existing technology, some designs have attempted to combine Chinese medicine bags (such as those containing Qianzhengsan ingredients) with thermal effectors to promote the recovery of acute facial paralysis by warming the meridians and dispersing cold. However, there are common defects such as unstable heat source power supply (such as unclear battery life of button batteries) and low drug penetration efficiency. Although some other electric stimulation masks use electrodes for electroacupuncture treatment, the rigid structure of the electrodes leads to poor wearing comfort, and there is a lack of dynamic impedance matching mechanism, which can easily cause skin burns or fluctuations in stimulation intensity, affecting the efficacy. In addition, existing equipment mostly focuses on a single treatment mode, fails to intelligently switch intervention strategies according to the stage of the disease (acute phase and recovery phase), and is difficult to achieve precise regulation throughout the entire cycle. Summary of the Invention

[0004] In response to the above problems, the present invention proposes a facial paralysis rehabilitation treatment mask and control system with integrated adjustable pulse electrical stimulation. Under the premise of ensuring safety, it can integrate acupoint targeted electrical stimulation, dynamic impedance adaptation, temperature-drug synergistic effect and biofeedback regulation, breaking through the bottlenecks of traditional technologies in sustainability, accuracy and comfort, and providing facial paralysis patients with efficient and convenient rehabilitation solutions.

[0005] In a first aspect, the present application proposes a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation, comprising:

[0006] The mask body has a flexible electrode group on its inner side corresponding to the acupuncture points for facial paralysis treatment. The flexible electrode group includes two groups of acupuncture point targeting electrode units, including a first electrode group for the temple area and a second electrode group for the corners of the mouth and cheek areas of the face.

[0007] Two snap-on electrical connection interfaces are symmetrically arranged on the outer edge of the mask body, and the snap-on electrical connection interfaces are electrically connected to the flexible electrode sheet group through wires;

[0008] A micro-electrical stimulation therapeutic device outputs adjustable pulse electrical signals to the flexible electrode group through a button-type electrical connection interface;

[0009] The micro-electric stimulation therapeutic device includes a pulse generation module, which is used to generate pulse waves. The pulse waves include dense waves, sparse waves, and intermittent waves.

[0010] In one embodiment, the micro-electrical stimulation therapeutic device also includes an output voltage control circuit for generating a driving voltage and a safety protection circuit for monitoring electrode impedance and triggering overcurrent protection. The output voltage control circuit and the safety protection circuit are integrated inside the therapeutic device.

[0011] In one embodiment, the output voltage control circuit includes:

[0012] Power supply module, used to boost the button battery output voltage to an adjustable DC voltage of 5 to 50V;

[0013] Main control MCU, built-in waveform parameter storage unit and impedance compensation algorithm module;

[0014] Dynamic impedance detection circuit, which measures the contact impedance between the electrode and the skin through a four-wire system;

[0015] The voltage-controlled constant current source receives the PWM signal output by the main MCU and drives the pulse generation module.

[0016] In one embodiment, the safety protection circuit includes:

[0017] AC excitation signal generator, used to output a sine wave signal with a frequency of 1kHz;

[0018] Current-voltage converter, used to measure the real-time current value flowing through the electrode;

[0019] A digital lock-in amplifier is used to resolve the real and imaginary parts of the skin impedance.

[0020] The present application also includes a control system for a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation, which is applicable to the above-mentioned facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation, and is characterized in that:

[0021] The main control module is used to dynamically select the pulse waveform mode based on the rehabilitation recognition results. The pulse waveform modes include: activating dense waves in the acute phase mode to enhance local blood circulation, and switching to sparse waves or intermittent waves in the recovery phase mode to promote neuromuscular function recovery;

[0022] A positioning control module independently drives the first electrode group and the second electrode group to implement targeted electrical stimulation for eyelid closure disorder and facial paralysis.

[0023] Dynamic impedance matching module monitors the electrode-skin contact impedance in real time and adjusts the output current intensity based on feedback to ensure the stability of the stimulation signal;

[0024] The main control module, positioning control module, and dynamic impedance matching module interact with each other via a bidirectional data bus to form a closed-loop control link.

[0025] In one embodiment, the control system further includes a multi-level security protection module for performing coordinated protection; wherein the coordinated protection includes:

[0026] When an abnormal increase in local temperature is detected, the output power is gradually reduced until the circuit is cut off;

[0027] Automatically performs electrode short circuit detection and contact status diagnosis during pulse pauses.

[0028] In one embodiment, the control system includes an integrated myoelectric biofeedback module that collects myoelectric signals of facial muscles through the first electrode group;

[0029] The main control module dynamically adjusts the pulse amplitude according to the strength of the electromyographic signal, and reduces the output current proportionally when the signal amplitude exceeds a preset threshold;

[0030] The dynamic impedance matching module synchronously analyzes the spectrum components of the electromyographic signal and triggers intermittent stimulation pause after identifying muscle fatigue characteristics;

[0031] The safety protection module receives abnormal myoelectricity data and forcibly cuts off the output and starts a vibration alarm when a spasmodic discharge pattern is detected.

[0032] In one embodiment, the control system includes a temperature compensation module, which is disposed on the surface of the second electrode group and integrates a distributed temperature sensor array;

[0033] The impedance matching module introduces a temperature-impedance coupling algorithm and determines temperature distribution data based on the temperature compensation module;

[0034] The positioning control module dynamically adjusts the electrode activation sequence based on the temperature distribution data, giving priority to the cooling area electrode group;

[0035] The main control module establishes a temperature change rate prediction model and reduces the pulse density in advance when it is predicted that the temperature rise rate exceeds the limit.

[0036] In one embodiment, the main control module integrates a wireless communication module to establish a two-way data connection with the mobile terminal;

[0037] The main control module encrypts the impedance matching parameters and stimulation mode data and uploads them to the cloud server;

[0038] The positioning control module receives the optimized stimulation plan sent from the cloud and verifies its compatibility with local security constraints;

[0039] The dynamic impedance matching module switches to the offline impedance baseline library when communication is interrupted and performs compensation using the most recent valid parameters.

[0040] In one embodiment, the positioning control module redistributes the stimulation intensity distribution of the remaining electrodes when a single electrode failure is detected;

[0041] The dynamic impedance matching module performs periodic self-calibration and verifies the integrity of the measurement channel by injecting test signals;

[0042] The main control module generates a visual fault code, sends it to the user terminal via the Bluetooth module, and guides wearing adjustments.

[0043] Other features and advantages of the present invention will be described in the following description, and in part will become apparent from the description, or will be understood by practicing the present invention. The purpose and other advantages of the present invention can be realized and obtained by the structures particularly pointed out in the written description and the accompanying drawings.

[0044] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings:

[0046] Figure 1 This is a three-dimensional diagram of the appearance of a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation according to an embodiment of the present invention;

[0047] Figure 2 This is a diagram of the stimulation signal control process of a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation in an embodiment of the present invention;

[0048] Figure 3 1 is a structural diagram of an auxiliary circuit in an embodiment of the present invention;

[0049] Figure 4 1 is a diagram of the rehabilitation control process in the rehabilitation stage according to an embodiment of the present invention;

[0050] Figure 5 This is a process diagram of the gradient response and active monitoring safety protection mode in an embodiment of the present invention;

[0051] Figure 6 A process diagram of electromyographic monitoring and adaptive treatment of spectral characteristics in an embodiment of the present invention;

[0052] Figure 7 This is a process diagram of precise stimulation of temperature compensation and heat distribution compensation in an embodiment of the present invention;

[0053] Figure 8 This is a planning and processing diagram of a cloud-end collaborative architecture according to an embodiment of the present invention;

[0054] Figure 9 This is a diagram of the calculation process for generating a redundant stimulation strategy and a self-checking and self-healing mechanism in an embodiment of the present invention. DETAILED DESCRIPTION

[0055] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0056] This application proposes a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation, see Figure 1 and Figure 2 The mask of the present application comprises: a mask body 1, the inner side of which is provided with a flexible electrode sheet group corresponding to the acupuncture point area for facial paralysis treatment, the flexible electrode sheet group comprising two groups of acupuncture point targeting electrode units, including: a first electrode group 2 for fitting the temple area, and a second electrode group 3 for fitting the corners of the mouth and cheek areas of the face;

[0057] The mask body 1 is made of medical silicone. In terms of geometric structure, its curvature is designed according to the three-dimensional facial modeling data to fit the cheekbone and mandibular contours. The mask body 1 is a stable support frame. The silicone material and the layout of the electrode sheets make the pressure of the electrode sheets and the acupoint area uniform. The acupoint targeting electrode unit is designed to fit the acupoints on the user's head to achieve precise targeted stimulation of the acupoints. The flexible electrode sheet group fits the user's skin better and does not cause skin pressure. The focus of this application is to combine traditional Chinese medicine acupoint theory with wearable devices, and pre-fix the electrode sheets to the corresponding acupoint areas of the mask (Yangbai-Taiyang / Dicang-Jiache) based on the three-dimensional facial modeling data. Based on the medical silicone material that fits the facial contour, the targeted stimulation effect is improved, and manual positioning is not required.

[0058] Two snap-on electrical connection interfaces are symmetrically arranged on the outer edge of the mask body 1, and the snap-on electrical connection interfaces are electrically connected to the flexible electrode sheet group through wires; the micro-electrical stimulation therapeutic device outputs an adjustable pulse electrical signal to the flexible electrode sheet group through the snap-on electrical connection interfaces;

[0059] In the generation of power supply and stimulation pulse signals, metal snaps and gold-plated contacts are used, and wires are used to connect the electrode group and the external treatment device, which facilitates quick disassembly and cleaning and disinfection, and is suitable for stimulation needs in the acute and recovery periods.

[0060] The micro-electrical stimulation therapeutic device includes a pulse generation module, which is used to generate pulse waves. The pulse waves include dense waves, sparse waves, and intermittent waves. A variety of pulse waves can achieve multi-waveform electrical stimulation and can realize comprehensive regulation of neuromuscular function.

[0061] During the actual implementation process, the electrodes are positioned on the acupoints, covering the main motor area of ​​the face. The electrodes accurately cover the temple area and cheeks. Through pulse signals of different frequencies, the pulse current acts on the deep tissues of the acupoints, stimulating nerve action potentials, promoting the release of acetylcholine, enhancing muscle contraction force, and increasing muscle tension.

[0062] The micro-electric stimulation therapeutic device has three built-in modes: dense wave, sparse wave, and intermittent wave. The dense wave is used for high-frequency stimulation to inhibit pain nerve conduction, block nerves, and at the same time dilate capillaries, accelerate the dilation of the capillary area, thereby driving the acceleration of the action of substances around the capillary area, such as the penetration of Qianzhengsan. Sparse waves are used in the form of low-frequency pulses to induce rhythmic muscle contraction, prevent atrophy, and are suitable for the recovery period. Intermittent waves achieve intermittent stimulation to avoid neural adaptive fatigue and promote synaptic plasticity reconstruction. The mask of this application only sends out stimulation signals to act on the expansion of muscles and blood vessels, but does not involve any treatment for the lesions of this application.

[0063] In actual implementation, the micro-electrical stimulation therapeutic device has a built-in four-wire impedance detection circuit, a temperature gradient sensor, and an overcurrent protection module. The four-wire impedance detection circuit measures the real part of the skin impedance through a 1kHz AC excitation signal, reflects the state of the stratum corneum and the imaginary part, reflects the ionic environment of the dermis, and dynamically adjusts the output voltage to compensate for poor contact. The temperature gradient sensor detects the surface temperature rise of the electrode through a distributed temperature sensor. When the local temperature exceeds the preset temperature value, it triggers power reduction protection to prevent burns. Ordinary electrical stimulators rely on users to locate acupuncture points by themselves, with a high error rate, and the fixed parameters cannot adapt to the disease stage. This application pre-fixes the electrode sheet on the corresponding acupuncture point area of ​​the mask based on the three-dimensional facial modeling data to ensure the targeted stimulation. Through a staged treatment strategy, dense waves + Chinese medicine warm compresses are used in the acute phase, for example: to accelerate blood circulation and drug penetration, and switch to sparse waves / intermittent waves in the recovery phase to rebuild neuromuscular function and achieve precise intervention throughout the entire cycle. Rigid electrodes press on the face, causing pain, and long-term wear can easily lead to skin damage. Silver fiber-silicone composite electrodes are used, conforming to the curvature of the face and distributing pressure evenly. The electrodes are separated from the mask body, facilitating cleaning and disinfection, extending its lifespan. The battery life of the button-cell-powered thermo-effector is unclear, and it lacks overload protection. The therapeutic device uses a rechargeable lithium battery, which is physically isolated from the mask body to reduce the risk of leakage. The three parameters of impedance, temperature, and current are collaboratively monitored, and the circuit is internally disconnected if abnormal conditions fall within a preset range. The therapeutic device is functionally separated from the protective mask, with the electrodes integrated into the mask fabric. The appearance is no different from that of an ordinary medical mask, allowing for daily wear. Stimulation intensity is adjusted in real time using electromyographic signals to avoid overtreatment.

[0064] In the actual implementation of this application, in order to avoid excessive stimulation or weak stimulation due to impedance difference (mainly fixed power supply, fixed voltage equipment due to voltage instability caused by impedance difference), it also includes auxiliary circuits, output voltage control circuits and safety protection circuits. Figure 2 , a button battery is used as the basic power source, and the voltage is increased to a preset adjustable range through the output voltage control circuit (in actual implementation, a DC-DC boost module can be used) to obtain a high voltage that can drive the electrical stimulation needs. In this process, the safety protection circuit adopts a charge pump topology structure, and realizes low ripple boosting through high-frequency switching to avoid voltage fluctuations that cause unstable stimulation intensity. The output voltage control circuit dynamically adjusts the main control MCU of the output voltage control circuit according to the boosted voltage, and adapts the sub-frequency. The high voltage in the acute phase can promote penetration, and the low voltage in the recovery phase can prevent spasms. When the impedance monitoring is used for surface stimulation, it mainly judges the degree of muscle recovery based on the impedance change, which has nothing to do with safety, so it does not involve overcurrent. The product of this application is a mask, which is easy to heat up when overcurrent occurs. Although it will not cause excessive temperature or burn the user's skin, it will also cause the user experience to be bad due to the high temperature.

[0065] The main control MCU is the core controller of the micro-electrical stimulation therapeutic device, with a built-in waveform parameter memory, which pre-stores the PWM duty cycle and frequency parameters of dense wave 50Hz, sparse wave 10Hz, and intermittent wave 0.5s on / 0.5s off.

[0066] This application uses waveform parameters to generate PWM signals, which are converted into constant current pulses through the voltage-controlled constant current source of the output voltage control circuit, so that the current under different waveforms can maintain stability and reduce errors.

[0067] This application realizes stepless regulation within a preset voltage range through an output voltage control circuit and a safety protection circuit. The safety protection circuit converts impedance monitoring into a poor contact warning, and based on the overcurrent protection of the output voltage control circuit, the parameters are adjustable and the safety redundancy is improved.

[0068] Regarding the voltage that can meet different stimulation intensities, as well as the electrode contact resistance and interference errors, please refer to Figure 3 The power supply end of the output voltage control circuit adjusts the voltage through the power supply module and outputs stable direct current. In actual implementation, a DC-DC boost chip is mainly used to boost the 3V button battery to an adjustable DC voltage of 5 to 50V to achieve voltage stimulation of different intensities. Different types of voltage stimulation are targeted at different neuromuscular stimulation functions.

[0069] The main control MCU has a built-in waveform parameter storage unit and impedance compensation algorithm module. The waveform parameter storage unit is used to store different types of stimulation waveforms. The impedance compensation algorithm module is based on real-time impedance values ​​and dynamically adjusts the PWM duty cycle according to the detected impedance value. Through a voltage-controlled constant current source, the current is maintained at a constant state to prevent fluctuations in stimulation intensity due to impedance changes. The dynamic impedance detection circuit measures the contact impedance between the electrode and the skin through a four-wire system. The four-wire system is in a state where excitation and sampling are separated, and two current lines and two voltage lines are used to eliminate interference from electrode contact resistance. The contact impedance of the electrode and skin is collected in real time, and the data is transmitted directly to the MCU.

[0070] In the actual implementation process, the output voltage control circuit is also equipped with a safety protection module including an overcurrent protection submodule, a temperature gradient control submodule and a battery monitoring submodule. Different from the safety protection circuit, the overcurrent protection submodule mainly prevents the current from being greater than 35 mA, which is the safety input specification for low-voltage products such as masks. The temperature gradient control submodule mainly monitors the temperature of the electrode through the NTC thermistor. Each time the temperature rises to the next gradient, the output power will be reduced to ensure the stability of the input voltage. The battery monitoring submodule mainly monitors excessive voltage. If the voltage exceeds 2.5V, the electrical stimulation of the mask will automatically shut down to prevent transient changes in stimulation caused by abnormal voltage, resulting in abnormal stimulation.

[0071] The contact between the metal electrode and the skin will generate an electrochemical polarization potential, which will be superimposed on the measurement signal, thereby triggering protection and protection. In addition, in the home environment, there will be fair interference from the mains and noise from the electromyographic signal. The real impedance change and the fluctuation caused by noise cannot be distinguished. To address these problems, this application uses the AC excitation signal generator of the safety protection circuit to limit the output frequency to a sine wave signal of 1KHz. The sine wave signal of 1KHz is the frequency at which the human skin impedance is highly stable and the imaginary capacitance characteristics are significant. Then, the electrode is injected into the skin, and there will be no polarization effect. As a result, the metal electrode does not generate an electrochemical polarization potential, and it will not interfere with the measurement.

[0072] A current-to-voltage converter measures the real-time current flowing through the electrodes. This voltage is then converted to a voltage signal and fed into a digital lock-in amplifier. By synchronizing the signal with the excitation signal, the real and imaginary components of the impedance, reflecting the skin resistance and capacitance, are extracted from the noise, achieving high-precision measurements. Furthermore, this more precise measurement significantly reduces false triggering of safety protection devices.

[0073] See Figure 4 This application also proposes a control system for a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation, specifically:

[0074] The main control module is used to dynamically select the pulse waveform mode according to the rehabilitation identification results, wherein the pulse waveform mode includes: activating dense waves in the acute phase mode to enhance local blood circulation, and switching to sparse waves or intermittent waves in the recovery phase mode to promote neuromuscular function recovery. If a fixed waveform is used, it can only be used in a certain rehabilitation stage, rather than throughout the entire cycle. Otherwise, because the stimulation intensity is too high or too low, the rehabilitation effect is basically no, or it cannot be treated at all, or even damage may be caused. The premise of selecting pulse waves in this application is to accurately divide the rehabilitation stages, and the mask of this application can be worn every day to achieve continuous detection and treatment throughout the entire cycle.

[0075] During the rehabilitation phase, the main control module automatically switches the pulse waveform based on a rehabilitation polarization staging algorithm, user-entered rehabilitation information, or historical rehabilitation data from other users, provided the rehabilitation standards and status are consistent. At a frequency of 50-100Hz, high-frequency stimulation promotes capillary dilation, automatically reducing any nerve edema. Switching to a 2-5Hz sparse wave and a 1-2Hz intermittent wave simulates nerve potential action, stimulating axons to automatically regenerate.

[0076] The positioning control module independently drives the first electrode group and the second electrode group to implement targeted electrical stimulation for symptoms of eyelid closure disorder and corner of mouth deviation; the positioning control module controls the first electrode group and the second electrode group respectively through an independent dual-channel H-bridge driver chip, and independently adjusts the stimulation intensity of the electrodes, so that the user's facial nerves will automatically change under dynamic expansion, and the user's face will return to normal under the automatic expansion of the facial nerves.

[0077] The dynamic impedance matching module monitors the electrode-skin contact impedance in real time and adjusts the output current intensity through feedback to ensure the stability of the stimulation signal; the dynamic impedance matching module is linked with the impedance detection circuit of the hardware layer, such as the phase-locked amplifier circuit. During the actual implementation process, the electrode-skin impedance value is collected every 10ms, and then the output of the compressed air constant current source is adjusted in real time through the PID algorithm to maintain the stimulation current fluctuation. Impedance matching is mainly used for safety protection and is not dynamically associated with the stimulation parameters. For example, when the electrode contact impedance increases due to loose wearing, the actual stimulation intensity decreases, but the system still operates according to the original parameters, resulting in ineffective treatment. The dynamic impedance matching mode of this application can maintain the stimulation effect at all times.

[0078] The main control module, positioning control module, and impedance matching module interact via a bidirectional data bus to form a closed-loop control link. In actual implementation, a safety protection module is also included, all of which achieve bidirectional data communication via the CAN bus.

[0079] This application uses the main control module to distribute rehabilitation cycles, the positioning control module to achieve targeted control of rehabilitation stimulation zones, and the impedance matching module to achieve stability matching of stimulation intensity, thereby comprehensively improving the rehabilitation effect.

[0080] See Figure 5 The control system also includes a multi-level security protection module to perform collaborative protection; wherein, collaborative protection includes:

[0081] When an abnormal increase in local temperature is detected, the output power is gradually reduced until the circuit is cut off;

[0082] Automatically performs electrode short circuit detection and contact status diagnosis during pulse pauses.

[0083] In actual implementation, the multi-level safety protection module includes an NTC thermistor array located along the edge of the electrode pad to monitor local temperature and its rate of increase in real time. Existing temperature monitoring technology primarily uses a single threshold cutoff. However, this single threshold cutoff interrupts treatment continuity, and if the threshold is set too high, there is a risk of burns.

[0084] If a local temperature anomaly or increase is detected, the output power is gradually reduced until the circuit is shut down. This is primarily for safety protection, with at least three levels of protection, reducing the PWM duty cycle to maintain a basic recovery effect. If recovery persists for an extended period, a safe mode is activated, ultimately shutting down the H-bridge drive circuit until the output is clamped to 0V.

[0085] During the pulse interval, the device will use the interval time of the fake stimulation to suspend the stimulation signal output, and then automatically switch to the detection mode. By injecting a 1mA constant current signal into the electrode and measuring the voltage drop, an alarm is triggered when the voltage is less than 0.5V.

[0086] During the contact status diagnosis process, the impedance spectrum of the electrode and skin is measured by the sweep frequency excitation signal, and the contact area is calculated as the interface capacitance. When S is less than 60% of the initial value, it is marked as poor contact, and the user is reminded to adjust the pressure of wearing the mask. The product of this application is a mask, so there must be a determination of the contact status, but the mask is usually handled and put on by the user himself. However, the mask of this application needs to be worn for a long time. After long-term wearing, the user's sense of sensation will decrease, and there will be no wearing feeling. At this time, the user cannot detect the wearing status, and the contact status diagnosis of this application plays this role.

[0087] See Figure 6 ,This application aims at the demand for fine control of facial muscles of patients with facial paralysis, and designs partitioned electrodes and multi-channel EMG acquisition. ,The problem that general-purpose equipment for the whole body cannot adapt to facial anatomy, the control system of this application includes an integrated electromyographic biofeedback module, which collects electromyographic signals of facial muscles through the first electrode group;

[0088] In actual implementation, the first electrode group has built-in Ag / AgCl surface electrodes to collect the electromyographic signals generated by the autonomous contraction of facial muscles. After the pre-amplifier circuit and band-pass filter remove the power frequency interference, the signals are transmitted to the main control module. There will be no antagonism between passive stimulation and active movement, which will affect the expansion efficiency of nerves and capillaries.

[0089] The main control module dynamically adjusts the pulse amplitude according to the strength of the electromyographic signal. When the signal amplitude exceeds the preset threshold, the output current is reduced proportionally. In specific implementation, the main control module decomposes the EMG signal into a 0-500Hz spectrum through fast Fourier transform, extracts time domain parameters to reflect the muscle contraction intensity, and terminates the frequency domain parameters of the MF set to identify muscle fatigue.

[0090] The dynamic impedance matching module simultaneously analyzes the EMG signal's spectral components, identifying signs of muscle fatigue and triggering an intermittent stimulation pause. When the EMG signal amplitude exceeds a preset threshold, the main control module proportionally reduces the pulse amplitude to prevent overstimulation and hemifacial spasm. The dynamic impedance matching module simultaneously analyzes the EMG spectrum and automatically triggers a two-second stimulation pause when it detects a continuous decrease in the MF for three seconds and an RMS fluctuation greater than 20%. During this pause, a low-intensity maintenance current is delivered to prevent excessive muscle fatigue and prevent muscle fiber damage.

[0091] The existing safety mechanism only triggers protection after a spasm occurs, but patients with facial paralysis have 2 to 3 seconds of abnormal EMG discharges (such as spike clusters) before facial spasms. Traditional systems cannot provide early warnings, which can easily lead to treatment interruptions or increased pain. This application receives abnormal electromyography data through a safety protection circuit, and forcibly cuts off the output and activates a vibration alarm when a spasmodic discharge pattern is detected. The safety protection circuit monitors the explosive peaks of the EMG signal in real time, and determines that it is a risk precursor such as a precursor to facial spasm. It immediately cuts off the H-bridge drive circuit and triggers an alarm through the built-in vibration motor of the mask.

[0092] See Figure 7 During the stimulation process, because the skin impedance has a strong temperature dependence, impedance deviation may occur without temperature compensation, resulting in fluctuations in electrical stimulation. Moreover, this product is a mask. During the rehabilitation process, the electrode and the skin are in close contact, which will lead to poor heat dissipation. If single-point temperature monitoring is used, the heat accumulation phenomenon in the edge area cannot be identified. Therefore, the control system of the present application is provided with a temperature compensation module, which is configured on the surface of the second electrode group and integrated with a distributed temperature sensor array; the distributed temperature sensor array is on the surface of the second electrode group, and the surface of the second electrode group is integrated with an 8-point NTC thermistor array, using a differential sampling circuit to collect temperature distribution data every 50ms, and transmit it to the main control module through the SPI bus to construct a facial temperature thermogram.

[0093] In order to ensure that the impedance does not deviate and the stimulation current does not fluctuate, the impedance matching module introduces a temperature-impedance coupling algorithm and determines the temperature distribution data based on the temperature compensation module. The impedance matching module introduces a coupling algorithm: Z(T) = Z0×[1+α(T-T0)+β(T-T0)] 2 ]; where Z0 is the impedance value at the reference temperature T0 (36°C), and α / β is the temperature coefficient that corrects the impedance measurement deviation caused by temperature changes in real time.

[0094] In view of the possible occurrence of heat accumulation areas on local edges, the positioning control module dynamically adjusts the electrode activation order according to the temperature distribution data, giving priority to the cooling area electrode group; in actual implementation, the positioning control module compares the temperature of each electrode area. When the temperature of a certain area is greater than 38°C (that is, 0.8°C higher than the average temperature), the electrode in that area is automatically switched to intermittent mode, and the stimulation duty cycle is reduced from 50% to 30%. At the same time, the cooling area electrode group with a temperature less than 37°C is preferentially activated to achieve balanced heat distribution through load transfer.

[0095] See Figure 8 The main control module establishes a temperature change rate prediction model and reduces the pulse density in advance when it predicts that the temperature rise rate exceeds the limit. The main control module establishes a temperature change rate prediction model based on an LSTM neural network. The input features include: current temperature, temperature rise rate, electrode activation history, and ambient temperature. The main control module predicts the temperature rise rate within a preset time period in the future. If the predicted value is greater than 0.5℃ / s, the pulse density is reduced in advance to avoid triggering passive protection.

[0096] During the stimulation process, if the device parameters are fixed, it cannot be dynamically optimized based on the patient's real-time physiological data, which increases the stimulation error rate and easily causes stimulation interruption. Therefore, the main control module of this application integrates a wireless communication module to establish a two-way data connection with the mobile terminal; the main control module integrates a Bluetooth / BLE dual-mode communication module to establish an encrypted connection with the mobile terminal (APP), which can upload real-time data, upload impedance matching parameters, stimulation mode, temperature / electromyography monitoring data and receive downlink instructions.

[0097] The main control module encrypts the impedance matching parameters and stimulation mode data and uploads them to the cloud server. The cloud server trains a personalized model through a federated learning algorithm after the main control module uploads the treatment data, outputs an optimized stimulation plan, and adjusts the waveform duty cycle based on the user's historical data.

[0098] The positioning control module receives the optimized stimulation plan sent from the cloud and verifies its compatibility with local security constraints. After receiving the cloud plan, the positioning control module automatically checks whether the key parameters comply with the local security firmware. If the constraints are exceeded, the module refuses to execute and feeds back to the cloud for re-optimization.

[0099] See Figure 9 When communication is interrupted, the dynamic impedance matching module switches to the offline impedance baseline library and uses the most recently valid parameters for compensation. The dynamic impedance matching module locally caches the three most recent valid treatment parameters. When a communication interruption is detected, it immediately switches to offline mode and calls the parameter set from the most recent successful treatment in the baseline library to maintain treatment continuity.

[0100] During actual stimulation, failure of a single electrode (e.g., wire breakage or poor contact) can result in no electrical stimulation in the corresponding area, necessitating device downtime and replacement. With long-term use, masks are subject to constant erosion from the user's breath, and this type of device is prone to drift in the presence of high humidity within its internal electronic components. Upon detecting a single electrode failure, the positioning control module redistributes the stimulation intensity distribution of the remaining electrodes. The positioning control module monitors the output current (I) and impedance (Z) of each electrode in real time. When a single electrode is detected with I = 0 (open circuit) or Z > 50kΩ (contact failure), the electrode reconstruction algorithm is immediately triggered. During this process, based on the facial nerve distribution model, the stimulation area of ​​the failed electrode is decomposed into the coverage areas of three adjacent valid electrodes, including the temporal, zygomatic, and buccal branches of the facial nerve. Intensity redistribution is then achieved by adjusting the PWM duty cycle to ensure that the electric field intensity in the treatment area remains within the neural activation threshold range.

[0101] The dynamic impedance matching module performs periodic self-calibration, verifying the integrity of the measurement channels by injecting test signals. In actual implementation, the dynamic impedance matching module performs self-calibration every 5 minutes of treatment (or before treatment begins): a 100μA, 1kHz sinusoidal test signal (well below the stimulation threshold and has no therapeutic effect) is injected into all electrodes, and the voltage response (U) of each channel is measured using a differential amplifier. The channel gain (G = U / I) and phase offset (θ) are calculated. If G deviates from the baseline value, it is determined that the channel is abnormal (such as op amp drift or poor wire contact), and the faulty channel is automatically marked and disabled.

[0102] In actual implementation, the mask of this application has a dedicated APP that interacts with the user's terminal device. When a problem occurs, the main control module generates a visual fault code, sends it to the user terminal via the Bluetooth module, and guides wearing adjustments. The main control module encodes the fault type as a 3-digit visual code, for example: E12 represents poor contact of the second electrode on the left, which is pushed to the user terminal via the Bluetooth module and triggers three levels of guidance: Level 1: Display a schematic diagram of the fault location (marking the failed electrode in red on the outline of the mask); Level 2: Text guidance (please adjust the upper left strap of the mask to ensure that the electrode fits the skin); Level 3: Video guidance (call the built-in short video of the correct wearing demonstration in the APP).

[0103] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if such changes and modifications fall within the scope of the claims and their equivalents, the present invention is intended to include such changes and modifications.

Claims

1. A facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation, characterized in that: include: The mask body (1) has a flexible electrode sheet group on its inner side corresponding to the acupuncture point area for facial paralysis treatment. The flexible electrode sheet group includes two groups of acupuncture point targeting electrode units, including: a first electrode group (2) for fitting the temple area, and a second electrode group (3) for fitting the corners of the mouth and cheek areas of the face; Two snap-on electrical connection interfaces are symmetrically arranged on the outer edge of the mask body (1), and the snap-on electrical connection interfaces are electrically connected to the flexible electrode sheet group via wires; A micro-electrical stimulation therapeutic device outputs adjustable pulse electrical signals to the flexible electrode group through a button-type electrical connection interface; The micro-electric stimulation therapeutic device includes a pulse generation module, which is used to generate pulse waves. The pulse waves include dense waves, sparse waves, and intermittent waves.

2. A facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 1, characterized in that: The micro-electrical stimulation therapeutic device also includes an output voltage control circuit for generating a driving voltage and a safety protection circuit for monitoring electrode impedance and triggering overcurrent protection. The output voltage control circuit and the safety protection circuit are integrated inside the therapeutic device.

3. A facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 2, characterized in that: The output voltage control circuit includes: Power supply module, used to boost the button battery output voltage to an adjustable DC voltage of 5 to 50V; Main control MCU, built-in waveform parameter storage unit and impedance compensation algorithm module; Dynamic impedance detection circuit, which measures the contact impedance between the electrode and the skin through a four-wire system; The voltage-controlled constant current source receives the PWM signal output by the main MCU and drives the pulse generation module.

4. A facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 2, characterized in that: The safety protection circuit includes: AC excitation signal generator, used to output a sine wave signal with a frequency of 1kHz; Current-voltage converter, used to measure the real-time current value flowing through the electrode; A digital lock-in amplifier is used to resolve the real and imaginary parts of the skin impedance.

5. A control system for a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation, applicable to a facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation according to any one of claims 1 to 4, characterized in that: The main control module is used to dynamically select the pulse waveform mode based on the rehabilitation recognition results. The pulse waveform modes include: activating dense waves in the acute phase mode to enhance local blood circulation, and switching to sparse waves or intermittent waves in the recovery phase mode to promote neuromuscular function recovery; A positioning control module independently drives the first electrode group and the second electrode group to implement targeted electrical stimulation for eyelid closure disorder and facial paralysis. Dynamic impedance matching module monitors the electrode-skin contact impedance in real time and adjusts the output current intensity based on feedback to ensure the stability of the stimulation signal; The main control module, positioning control module, and dynamic impedance matching module interact with each other via a bidirectional data bus to form a closed-loop control link.

6. The control system of the facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 5, characterized in that: The control system also includes a multi-level security protection module to perform coordinated protection; wherein the coordinated protection includes: When an abnormal increase in local temperature is detected, the output power is gradually reduced until the circuit is cut off; Automatically performs electrode short circuit detection and contact status diagnosis during pulse pauses.

7. The control system of the facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 5, characterized in that: The control system includes an integrated myoelectric biofeedback module, which collects myoelectric signals of facial muscles through the first electrode group; The main control module dynamically adjusts the pulse amplitude according to the strength of the electromyographic signal, and reduces the output current proportionally when the signal amplitude exceeds a preset threshold; The dynamic impedance matching module synchronously analyzes the spectrum components of the electromyographic signal and triggers intermittent stimulation pause after identifying muscle fatigue characteristics; The safety protection module receives abnormal myoelectricity data and forcibly cuts off the output and starts a vibration alarm when a spasmodic discharge pattern is detected.

8. The control system of the facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 5, characterized in that: The control system includes a temperature compensation module, which is configured on the surface of the second electrode group and integrated with a distributed temperature sensor array; The dynamic impedance matching module introduces a temperature-impedance coupling algorithm and determines temperature distribution data based on the temperature compensation module; The positioning control module dynamically adjusts the electrode activation sequence based on the temperature distribution data, giving priority to the cooling area electrode group; The main control module establishes a temperature change rate prediction model and reduces the pulse density in advance when it is predicted that the temperature rise rate exceeds the limit.

9. The control system of the facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 5, characterized in that: The main control module integrates a wireless communication module to establish a two-way data connection with the mobile terminal; The main control module encrypts the impedance matching parameters and stimulation mode data and uploads them to the cloud server; The positioning control module receives the optimized stimulation plan sent from the cloud and verifies its compatibility with local security constraints; The dynamic impedance matching module switches to the offline impedance baseline library when communication is interrupted and performs compensation using the most recent valid parameters.

10. The control system of the facial paralysis rehabilitation treatment mask with integrated adjustable pulse electrical stimulation as claimed in claim 5, characterized in that: The positioning control module redistributes the stimulation intensity distribution of the remaining electrodes when detecting failure of a single electrode; The dynamic impedance matching module performs periodic self-calibration and verifies the integrity of the measurement channel by injecting test signals; The main control module generates a visual fault code, sends it to the user terminal via the Bluetooth module, and guides wearing adjustments.

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