Wearable magnetic stimulation device for neurological rehabilitation and control method thereof

Abstract

The embodiment of the invention provides a wearable magnetic stimulation device for neurological rehabilitation and a control method thereof, and belongs to the technical field of magnetic field treatment instruments. The device comprises a flexible circuit board module which is used for supporting and connecting each functional module and is of a flexible extensible structure; the magnetic stimulation module is configured to generate a magnetic field to achieve nerve stimulation, the magnetic stimulation module comprises a plurality of coil units arranged in an array mode, and each coil unit can be independently controlled to achieve multi-block targeted magnetic stimulation output; the dynamic shielding layer modules are arranged on the outer sides of the coil units respectively, each coil unit is correspondingly provided with one dynamic shielding unit, and the dynamic shielding layer modules are used for limiting magnetic field diffusion of the corresponding coil unit and enhancing the magnetic field focusing effect of the corresponding coil unit; and the control module is used for dynamically adjusting the working states of the magnetic stimulation module and the dynamic shielding layer module. According to the scheme, the problems of poor targeting and lack of dynamic regulation in existing magnetic stimulation are solved.

Description

Technical Field

[0001] This invention relates to the field of magnetic field therapy device technology, specifically to a wearable magnetic stimulation device for neurorehabilitation and a control method for the wearable magnetic stimulation device for neurorehabilitation. Background Technology

[0002] Magnetic stimulation therapy is a medical method that uses magnetic fields to act on human tissues to achieve neuromodulation and rehabilitation treatment. It is widely used in the rehabilitation of the central and peripheral nervous systems. With the increasing demand for rehabilitation medicine, wearable magnetic stimulation devices have developed rapidly in recent years as a portable and personalized treatment solution. These devices typically generate an alternating magnetic field by injecting current into a coil, which in turn induces a therapeutic current to stimulate target nerve or muscle areas, thus assisting in rehabilitation training.

[0003] However, existing wearable magnetic stimulation devices still face several technical bottlenecks that limit their further clinical application. Firstly, most existing devices employ a single or large-scale coil structure with a diffuse magnetic field distribution, lacking an effective magnetic field focusing mechanism. This results in a wide stimulation range but insufficient precision, making it difficult to achieve efficient targeted stimulation of specific small areas and easily causing misstimulation and side effects in non-targeted areas. Secondly, most current devices primarily set fixed stimulation parameters under static conditions, lacking the ability to adaptively adjust to the user's dynamic state in real time. When the user moves or changes posture during rehabilitation training, the magnetic stimulation position is prone to shifting, making timely correction difficult and affecting the stimulation effect and treatment safety.

[0004] Therefore, improving the targeting accuracy of magnetic stimulation and achieving real-time adjustment and control of the device in dynamic motion environments have become key technical issues that urgently need to be addressed in the field of wearable magnetic stimulation devices. Summary of the Invention

[0005] The purpose of this invention is to provide a wearable magnetic stimulation device and its control method for neurorehabilitation, so as to at least solve the problems of insufficient targeting accuracy and lack of dynamic adjustment capability of existing magnetic stimulation devices.

[0006] To achieve the above objectives, a first aspect of the present invention provides a wearable magnetic stimulation device for neurorehabilitation, the device comprising: a flexible circuit board module for supporting and connecting various functional modules, having a flexible and stretchable structure; a magnetic stimulation module configured to generate a magnetic field to achieve neurostimulation, the magnetic stimulation module comprising multiple arrayed coil units, each coil unit being independently controllable to achieve targeted magnetic stimulation output to multiple blocks; a dynamic shielding layer module disposed on the outside of each coil unit, each coil unit having a corresponding dynamic shielding unit for limiting the magnetic field diffusion of the corresponding coil unit and enhancing the magnetic field focusing effect of the corresponding coil unit; and a control module for dynamically adjusting the working state of the magnetic stimulation module and the dynamic shielding layer module.

[0007] Optionally, the flexible circuit board module is a multi-layer composite structure; the flexible circuit board includes a polyimide substrate layer, a metal conductive line layer, and at least one polyimide protective layer; the edge area of ​​the flexible circuit board module is provided with folding gaps and reserved expansion ports, and a grid-like stress relief hole is formed on the circuit board, and the expansion port is electrically connected to the additional module through a connector.

[0008] Optionally, the magnetic stimulation module further includes a drive circuit; the drive circuit includes a programmable pulse generator, a power amplifier, and a coil selection switch; the drive circuit is configured to adjust the working state of each coil unit based on the control signal sent by the control module, and to monitor and correct the output magnetic field parameters in real time.

[0009] Optionally, the dynamic shielding layer module is a multi-layer stacked structure; the dynamic shielding layer module includes a flexible magnetically conductive metal layer, an electrically controlled deformation layer, and an insulating buffer layer; the electrically controlled deformation layer is a polymer layer based on the electrostriction effect, including at least one dielectric elastomer film and a matching flexible electrode layer, so as to change the magnetic field guiding path of the magnetically conductive metal layer by deformation when a voltage is applied; the dynamic shielding layer module is electrically connected to the control module and can perform shielding area adjustment by region and / or by angle according to the control commands sent by the control module.

[0010] Optionally, the device further includes an electromyography (EMG) electrode module; the EMG electrode module is used to acquire EMG signals from the wearing area in real time and transmit the acquired EMG signals to a control module, so that the control module can use the EMG signals as a dynamic shielding layer module. The EMG electrode module includes multiple electrode pads, each electrode pad is arranged in an array and fixed to the surface of a flexible circuit board by a conductive adhesive layer, and connected to a signal amplifier; the signal amplifier, together with a bandpass filter and an analog-to-digital converter module connected in series, forms a signal acquisition module for acquiring EMG signals.

[0011] Optionally, the device further includes a temperature probe module for real-time detection of temperature changes in the wearing area and providing temperature data to the control module for overheat protection and safety adjustment. The temperature probe module consists of multiple NTC thermistors. Each NTC thermistor is connected to a signal conditioning module via flexible wiring. The signal conditioning module includes a regulated power supply, a signal amplifier, and an A / D converter for acquiring and digitizing data at various temperature points. The signal conditioning module is also used to trigger power limiting or interrupt magnetic stimulation output when the detected temperature exceeds a set threshold.

[0012] Optionally, the device further includes an IMU module for detecting the device's attitude and motion state and providing the detection data to the control module. The IMU module includes a multi-axis sensor chip that integrates a three-axis gyroscope, a three-axis accelerometer, and a three-axis magnetometer, which are used to collect three-axis angular velocity, three-axis acceleration, and three-axis magnetic field data in real time as detection data. The IMU module also includes a low-power microcontroller unit configured with a Kalman filter algorithm for calculating the device's spatial pose and micro-displacement data in real time and sending the processed data to the control module for dynamic compensation control.

[0013] Optionally, the control module includes a processing module, a memory unit, a power management unit, and a Bluetooth communication module. The processing module generates real-time adjustment commands based on the acquired electromyographic signals, temperature signals, and data processed by the IMU module, and outputs control signals to the magnetic stimulation module and the dynamic shielding layer module through a PWM interface. The Bluetooth communication module establishes a communication connection with the user's mobile control terminal to upload the real-time operating status of the device to the user terminal and to transmit the control commands issued by the user to the processing module, so that the processing module outputs control signals to the magnetic stimulation module and the dynamic shielding layer module through the PWM interface based on the control commands issued by the user.

[0014] A second aspect of the present invention provides a control method for a wearable magnetic stimulation device for neurorehabilitation. The method is applied to the aforementioned wearable magnetic stimulation device for neurorehabilitation and is executed by a control module. The method includes: parsing processed data output from an IMU module to obtain the spatial position and offset parameters of the device as motion parameters; adjusting the data acquisition strategy of an electromyography (EMG) electrode module based on the motion parameters, and acquiring corresponding EMG signal data based on the adjusted EMG electrode module; extracting features from the EMG signal data to identify the nerve excitability level of the target area, and generating preliminary stimulation parameters based on the nerve excitability level; simultaneously receiving temperature data output from a temperature probe module, and combining the temperature data with the preliminary stimulation parameters to perform a safety check and temperature threshold verification, using the verification results as the basis for adjustment; generating control instructions for the magnetic stimulation module based on the adjustment basis; wherein the control instructions for the magnetic stimulation module include any one or more of the activation state, output intensity, pulse frequency, and working sequence of each coil unit; and simultaneously generating control instructions for a dynamic shielding layer module according to the motion parameters and the stimulation requirements for setting; wherein the control instructions for the dynamic shielding layer module include the focusing direction and / or shielding range of each dynamic shielding unit.

[0015] On the other hand, the present invention provides a computer-readable storage medium storing instructions that, when executed on a computer, cause the computer to perform the above-described control method for a wearable magnetic stimulation device for neurorehabilitation.

[0016] Through the above technical solutions, the present invention achieves reliable integration and flexible adaptation of various functional modules through a flexible circuit board module, which can meet the fitting requirements of different human body parts; through the array coil unit design of the magnetic stimulation module and the independent control of each unit, precise targeted magnetic stimulation of multiple blocks can be achieved, significantly improving the positioning accuracy of stimulation; the dynamic shielding layer module is respectively set on the outside of each coil unit, which can effectively limit the diffusion of magnetic field and enhance the magnetic field focusing effect, further improving the unit-level stimulation targeting; the control module is used to dynamically adjust the working state of the magnetic stimulation module and the dynamic shielding layer module, so that the device can adjust the output in real time when moving or changing position, maintaining the accuracy of the stimulation area, thereby overcoming the problems of poor targeting and lack of dynamic adjustment in the prior art.

[0017] Other features and advantages of the embodiments of the present invention will be described in detail in the following detailed description section. Attached Figure Description

[0018] The accompanying drawings are provided to further illustrate embodiments of the present invention and form part of the specification. They are used together with the following detailed description to explain the embodiments of the present invention, but do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the structure of a wearable magnetic stimulation device for neurorehabilitation provided in one embodiment of the present invention. Figure 2 This is an overall schematic diagram of a wearable magnetic stimulation device for neurorehabilitation provided in one embodiment of the present invention. Figure 3 This is a flowchart of the steps of a control method for a wearable magnetic stimulation device for neurorehabilitation provided in one embodiment of the present invention.

[0019] 10 - Flexible circuit board module; 20 - Magnetic stimulation module; 30 - Dynamic shielding layer module; 40 - Control module; 50 - Electromyographic electrode module; 60 - Temperature probe module; 70 - IMU module. Detailed Implementation

[0020] The specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0021] Figure 1 This is a structural diagram of a wearable magnetic stimulation device for neurorehabilitation provided in one embodiment of the present invention. Figure 1 As shown, this invention provides a wearable magnetic stimulation device for neurorehabilitation. The device includes: a flexible circuit board module 10 for supporting and connecting various functional modules, which is a flexible and stretchable structure; a magnetic stimulation module 20 configured to generate a magnetic field to achieve nerve stimulation, the magnetic stimulation module 20 including multiple arrayed coil units, each coil unit being independently controllable to achieve targeted magnetic stimulation output to multiple blocks; a dynamic shielding layer module 30 respectively disposed on the outside of each coil unit, each coil unit corresponding to a dynamic shielding unit, used to limit the magnetic field diffusion of the corresponding coil unit and enhance the magnetic field focusing effect of the corresponding coil unit; and a control module 40 for dynamically adjusting the working state of the magnetic stimulation module 20 and the dynamic shielding layer module 30.

[0022] Preferably, the flexible circuit board module 10 has a multi-layer composite structure; the flexible circuit board includes a polyimide substrate layer, a metal conductive line layer, and at least one polyimide protective layer; the edge area of ​​the flexible circuit board module 10 is provided with folding gaps and reserved expansion ports, and a grid-like stress relief hole is formed on the circuit board, and the expansion port is electrically connected to the additional module through a connector.

[0023] In this embodiment of the invention, the flexible circuit board module 10 is a multilayer composite structure, specifically including at least one polyimide (PI) substrate layer, one metal conductive circuit layer, and at least one polyimide protective layer. The polyimide substrate layer serves as the supporting foundation for the entire circuit board, employing a polyimide film with a thickness between 25 and 75 micrometers, exhibiting good flexibility and high-temperature resistance. The metal conductive circuit layer is preferably a copper foil layer with a thickness between 18 and 35 micrometers, formed with predetermined circuit patterns through processes such as photolithography and etching to achieve electrical connections between various functional modules. The polyimide protective layer is located outside the conductive circuit layer, used to encapsulate the circuit, prevent physical damage and moisture corrosion from the external environment, and provide necessary insulation protection.

[0024] To enhance the adaptability and durability of the device, the edge region of the flexible circuit board module 10 is specially designed with folding slots. These folding slots are implemented using an alternating elongated slot structure, with a preferred width of 0.5 mm to 1.5 mm. This effectively reduces local stress concentration during bending or curved fitting, preventing circuit board breakage. The edge also features reserved expansion ports, each including several pads and mounting holes. These ports allow for electrical connection to additional modules (such as extended sensor units or communication modules) via connectors. The expansion ports are designed with at least 8 electrical connection channels to facilitate subsequent functional upgrades or customization.

[0025] Furthermore, to further improve the flexibility and fatigue resistance of the circuit board, a grid-like stress relief hole is designed on the main surface of the circuit board. This stress relief hole is an array of circular or rectangular holes, preferably with a diameter between 0.3 mm and 0.8 mm and a spacing of 2 mm to 5 mm. The grid-like stress relief hole can release internal stress during localized bending, reducing the risk of material fatigue accumulation and improving overall lifespan.

[0026] Through the aforementioned multi-layered structure and detailed optimization design, the flexible circuit board module 10 not only reliably supports and connects various functional modules, but also possesses excellent flexibility and adaptability, capable of accommodating the bending shape of different wearing positions, while facilitating subsequent module expansion and functional integration. This structure effectively improves the stability and reliability of the device under long-term wear and dynamic application scenarios.

[0027] Preferably, the magnetic stimulation module 20 further includes a driving circuit; the driving circuit includes a programmable pulse generator, a power amplifier, and a coil selection switch; the driving circuit is configured to adjust the working state of each coil unit based on the control signal sent by the control module 40, and to monitor and correct the output magnetic field parameters in real time.

[0028] In this embodiment of the invention, the magnetic stimulation module 20 not only includes an array of coil units, but also a driving circuit for precise driving control of each coil unit. The driving circuit specifically includes a programmable pulse generator, a power amplifier, and a coil selection switch. The programmable pulse generator generates pulse signals with adjustable parameters, preferably with a frequency range of 1 Hz to 100 Hz and a pulse width range of 50 microseconds to 2 milliseconds, flexibly adapting to the nerve stimulation needs of different rehabilitation scenarios. The power amplifier adopts a bipolar output design with a rated output voltage range of ±24 volts to ±48 volts to ensure that the coil units can obtain sufficient driving current to achieve effective magnetic field excitation.

[0029] The coil selection switch employs a multiplexed structure, including several electronic switching components, allowing independent selection and control of each coil in the array coil unit. This enables multi-block targeted activation or sequential dynamic scanning modes. To enhance control accuracy and safety, the drive circuit also integrates a real-time monitoring circuit. This circuit acquires the current and voltage signals of each coil and dynamically compares the actual output magnetic field parameters. If a deviation exceeds the set range, a feedback adjustment mechanism is triggered to automatically correct the output parameters, ensuring the stability of the magnetic stimulation process.

[0030] Through the above design, high-precision electrical signal control can be achieved in the application of multi-block array magnetic stimulation. This not only ensures the independent activation capability of each coil unit, but also provides a real-time monitoring and feedback correction mechanism, effectively improving the reliability and accuracy of magnetic stimulation and meeting the high-standard application requirements in dynamic rehabilitation scenarios.

[0031] Preferably, the dynamic shielding layer module 30 has a multi-layer stacked structure; the dynamic shielding layer module 30 includes a flexible magnetically conductive metal layer, an electrically controlled deformation layer, and an insulating buffer layer; the electrically controlled deformation layer is a polymer layer based on the electrostriction effect, including at least one dielectric elastomer film and a matching flexible electrode layer, so as to change the magnetic field guiding path of the magnetically conductive metal layer by deformation when a voltage is applied; the dynamic shielding layer module 30 is electrically connected to the control module 40 and can perform shielding area adjustment by region and / or by angle according to the control commands sent by the control module 40.

[0032] In this embodiment of the invention, the dynamic shielding layer module 30 includes at least a flexible magnetically conductive metal layer, an electrically controlled deformation layer, and an insulating buffer layer. The flexible magnetically conductive metal layer is preferably made of a high-permeability material, such as a ferrite film or nickel-iron alloy foil, with a thickness ranging from 20 micrometers to 100 micrometers, which can effectively guide and concentrate magnetic flux to limit magnetic field diffusion. To ensure overall flexibility, the magnetically conductive layer has bendable properties, adapting to fit on the outside of the coil unit at different wearing locations.

[0033] An electrically controlled deformation layer is used to dynamically adjust the morphology of the magnetically conductive metal layer, thereby changing the guiding path of the magnetic field. This electrically controlled deformation layer is a polymer layer based on the electrostrictive effect, preferably employing a dielectric elastomer structure, including at least one dielectric elastomer film and flexible electrode layers covering both sides of it. The dielectric elastomer film can be made of materials such as polydimethylsiloxane (PDMS) or thermoplastic polyurethane (TPU), with a film thickness preferably between 50 micrometers and 200 micrometers. The flexible electrode layers are formed using conductive silver paste or a carbon-based conductive coating to ensure a uniform electric field distribution. When a control voltage is applied to both ends of the flexible electrodes, the dielectric elastomer film undergoes compressive deformation along its thickness direction and stretches along its in-plane direction, thereby causing local morphological changes in the magnetically conductive metal layer, achieving dynamic controllability of the magnetic field focusing angle and the shielding area.

[0034] An insulating buffer layer is positioned between the electrically controlled deformation layer and the magnetically conductive metal layer. It primarily serves for electrical isolation and buffer protection, and is preferably made of polyimide film or silicone material. Its thickness can range from 5 micrometers to 50 micrometers, ensuring insulation while enhancing the overall flexibility and durability of the structure. The dynamic shielding layer module 30 is electrically connected to the control module 40 via wires. It receives voltage commands from the control module 40 and, based on preset area position or angle information, precisely adjusts the shielding range. For example, the focusing of a single probe can be adjusted individually by array area, or the angles of multiple shielding units can be adjusted in a coordinated manner to adapt to different treatment scenarios.

[0035] Through this multi-layer flexible structure design, the dynamic shielding module 30 can not only achieve static focusing of the magnetic field, but also has the ability to dynamically adjust in real time, so that the magnetic stimulation output can maintain high-precision targeting in various motion states, thereby effectively overcoming the problem that traditional magnetic shielding structures cannot be actively adjusted.

[0036] Preferably, the device further includes an electromyography (EMG) electrode module 50; the EMG electrode module 50 is used to acquire EMG signals from the wearing area in real time and transmit the acquired EMG signals to the control module 40, so that the control module 40 can use the EMG signals as a dynamic shielding layer module 30. The EMG electrode module 50 includes multiple electrode pads, each electrode pad is fixed to the surface of a flexible circuit board in an array by a conductive adhesive layer and connected to a signal amplifier; the signal amplifier, together with a bandpass filter and an analog-to-digital converter module connected in series, forms a signal acquisition module for acquiring EMG signals.

[0037] In this embodiment of the invention, the device further includes an electromyography (EMG) electrode module 50, which is used to acquire EMG signals from the wearing area in real time and transmit the acquired EMG signal data to the control module 40 as input for the closed-loop adjustment of the dynamic shielding layer module 30 and the magnetic stimulation module 20. The EMG electrode module 50 specifically includes multiple electrode pads arranged in an array and fixed to the surface of a flexible circuit board by a conductive adhesive layer. Preferably, each electrode pad has a diameter of 5 mm to 10 mm and is made of silver / silver chloride (Ag / AgCl) material to ensure high conductivity and stable biocompatibility. The spacing between the electrodes can be set in the range of 10 mm to 20 mm to form a reasonable signal acquisition grid to adapt to the electrophysiological characteristics of different wearing sites.

[0038] To achieve high-quality signal acquisition, each electrode is connected to a signal amplifier via a conductive path. The signal amplifier uses a high input impedance (≥10^12Ω) operational amplifier chip to avoid signal attenuation caused by the high impedance electrode interface. The output of the signal amplifier is connected to a series bandpass filter and an analog-to-digital converter module, which together constitute the signal acquisition module. The preferred cutoff frequency range of the bandpass filter is 20 Hz to 450 Hz, used to filter out low-frequency drift and high-frequency noise, extracting effective electromyographic signals. The resolution of the analog-to-digital converter module is recommended to be no less than 12 bits to ensure that the accuracy of the digitized signal meets the requirements of subsequent analysis and processing.

[0039] To enhance anti-interference capabilities, the entire signal acquisition module is equipped with a shielding layer. This shielding layer uses a copper-plated mesh structure and is connected to the grounding layer of the flexible circuit board to reduce the impact of external electromagnetic interference. The signal cables employ a twisted-pair shielded structure, further improving the stability of signal transmission. The signal acquisition module can be integrated with the flexible circuit board via a pin header or FPC interface, facilitating subsequent assembly and maintenance.

[0040] Through the above structural design, the electromyographic electrode module 50 can not only achieve efficient real-time acquisition of electromyographic signals in the target area, but also ensure the stability of signal quality during wearing and exercise, ensuring that the subsequent closed-loop control can be adjusted in real time based on accurate bioelectrical data, thereby effectively improving the stimulation accuracy and safety of the entire device.

[0041] Preferred, such as Figure 2The device also includes a temperature probe module 60, which is used to detect temperature changes in the wearing area in real time and provide temperature data to the control module 40 for the control module 40 to perform overheat protection and safety adjustment. The temperature probe module 60 is composed of multiple NTC thermistors. Each NTC thermistor is connected to the signal conditioning module through flexible wiring. The signal conditioning module includes a regulated power supply, a signal amplifier, and an A / D converter, which are used to collect and digitize data at various temperature points. The signal conditioning module is also used to trigger power limiting or interrupt magnetic stimulation output when the detected temperature exceeds a set threshold.

[0042] In this embodiment of the invention, the device further includes a temperature probe module 60, which is used to detect temperature changes in the wearing area in real time and provide the detected temperature data to the control module 40 for overheat protection and safety adjustment operations. The temperature probe module 60 consists of multiple NTC thermistors, each of which is a negative temperature coefficient (NTC) thermistor with high sensitivity and fast response characteristics, preferably with a resistance range of 10 kΩ to 100 kΩ, enabling accurate detection within a temperature range of 0°C to 60°C. The thermistors are evenly arranged at key locations on the flexible circuit board, such as near the peripheral area of ​​each magnetic stimulation unit, to cover the entire wearing area and form a temperature monitoring grid. Each NTC thermistor is electrically connected to the signal conditioning module via flexible wiring, which employs a multi-layer shielded wire structure to ensure anti-interference capability during signal transmission.

[0043] The signal conditioning module includes a regulated power supply, a signal amplifier, and an A / D converter. The regulated power supply provides a constant bias voltage to the thermistor, preferably 3.3V or 5V, to ensure the stability of the measurement data. The signal amplifier employs a low-noise amplifier circuit with high input impedance, effectively amplifying the weak voltage changes of the thermistor, with a preferred amplification factor between 10 and 100 times. The amplified analog signal is input to the A / D converter, which preferably has a resolution of at least 12 bits to ensure sufficient accuracy of the digitized temperature data. The converted temperature data is connected to the control module 40 via a flexible ribbon cable for real-time data transmission.

[0044] In addition, the signal conditioning module integrates a temperature threshold comparison circuit or software threshold judgment logic. This automatically triggers a safety mechanism when the temperature exceeds a set safety threshold (e.g., 45°C), performing power limiting or pausing the magnetic stimulation output, and issuing an overheat alarm signal. This overheat protection effectively prevents local tissue overheating caused by prolonged stimulation or abnormal operating conditions, ensuring safety during wear.

[0045] Through the above structural design, the temperature probe module 60 realizes a complete functional chain of multi-point real-time temperature detection, signal amplification and digital acquisition, and automatic response to abnormal temperatures. This not only improves the temperature control accuracy but also enhances the safety assurance capability of the entire device in complex application scenarios.

[0046] Preferably, in rehabilitation settings, wearable magnetic stimulation devices typically move or change posture with the user's limb movements. This is especially true during active rehabilitation training, limb extension, or walking, where the device's position and angle are difficult to maintain absolute stability. Existing magnetic stimulation devices often operate with fixed parameters and lack real-time monitoring of motion, leading to potential target point misalignment during use. This not only reduces treatment effectiveness but may also cause false stimulation of adjacent non-target areas, increasing discomfort and safety risks. Therefore, this invention employs a detection mechanism that can sense the device's position, posture, and motion in real time, providing real-time data support for subsequent dynamic compensation adjustments and ensuring that magnetic stimulation is always accurately applied to the predetermined target area.

[0047] Based on this, the device also includes an IMU module 70, used to detect the attitude and motion state of the device and provide the detection data to the control module 40; the IMU module 70 includes a multi-axis sensor chip, which integrates a three-axis gyroscope, a three-axis accelerometer and a three-axis magnetometer, used to collect three-axis angular velocity, three-axis acceleration and three-axis magnetic field data in real time as detection data; the IMU module 70 also includes a low-power microcontroller unit, which is configured with a Kalman filter algorithm, used to calculate the spatial pose and micro-displacement data of the device in real time, and send the processed data to the control module 40 for dynamic compensation control.

[0048] In this embodiment of the invention, the device further includes an IMU (Inertial Measurement Unit) module for detecting the device's attitude and motion state, enabling real-time monitoring of the device's position changes, and providing the detected data to the control module 40 for dynamic compensation control. The IMU module 70 mainly consists of a multi-axis sensor chip and a set of low-power microcontroller units. The multi-axis sensor chip integrates a three-axis gyroscope, a three-axis accelerometer, and a three-axis magnetometer, enabling comprehensive detection of 9-axis attitude data. The three-axis gyroscope is used to acquire real-time angular velocity data of the device along the X, Y, and Z axes, with a preferred range of ±500 dps to ±2000 dps and a sampling rate set from 100 Hz to 1 kHz to meet the high-precision requirements in dynamic scenarios. The three-axis accelerometer is used to detect acceleration data along the three axes, with a preferred range of ±2g to ±16g to ensure the capture of rapid movements and minute displacements of the wearable device. The three-axis magnetometer is used to sense real-time changes in the external geomagnetic field, providing absolute orientation information and improving the long-term stability of attitude calculation.

[0049] To ensure real-time data processing and low power consumption, the IMU module 70 integrates a low-power microcontroller unit (MCU). This MCU embeds a digital signal processing unit and is equipped with a Kalman filter algorithm. The Kalman filter algorithm fuses data from the gyroscope, accelerometer, and magnetometer outputs, performing noise reduction, drift compensation, and attitude reconstruction on the acquired raw signals. It can calculate the three-dimensional spatial attitude, including pitch, roll, and yaw angles, as well as micro-displacement data in real time. The MCU's operating frequency is preferably between 48 MHz and 96 MHz, and its memory capacity is no less than 32 KB to ensure smooth data processing. The filtered attitude data is output in the form of structured data packets and transmitted to the control module 40 via a serial port or I2C interface.

[0050] Furthermore, to improve the stability of the IMU module 70 in complex working environments, the sensor chip of the IMU module 70 is fixed to the flexible circuit board via a flexible flat cable, and an external shock-absorbing encapsulation layer is provided, using silicone or thermoplastic elastomer to reduce the impact of vibration or shock on data acquisition. The power supply section is equipped with a low dropout voltage regulator chip, providing a stable operating voltage of 3.3V, and integrates a power-down detection function to prevent measurement errors caused by abnormal voltage.

[0051] Through the above structural and algorithm design, the IMU module 70 can not only acquire multi-axis motion data in real time and output high-precision spatial pose information after filtering and fusion algorithms, but also provide real-time and reliable data support for subsequent dynamic compensation of magnetic stimulation parameters when the device undergoes dynamic changes such as displacement and rotation, thereby significantly improving the stimulation accuracy and safety of the device in complex motion scenarios.

[0052] Preferably, the control module 40 includes a processing module, a memory unit, a power management unit, and a Bluetooth communication module. The processing module is used to generate real-time adjustment commands based on the acquired electromyographic signals, temperature signals, and data processed by the IMU module 70, and output control signals to the magnetic stimulation module 20 and the dynamic shielding layer module 30 through the PWM interface. The Bluetooth communication module establishes a communication connection with the user's mobile control terminal to upload the real-time operating status of the device to the user terminal and to transmit the control commands issued by the user to the processing module, so that the processing module outputs control signals to the magnetic stimulation module 20 and the dynamic shielding layer module 30 through the PWM interface based on the control commands issued by the user.

[0053] In this embodiment of the invention, the control module 40 includes a processing module, a memory unit, a power management unit, and a Bluetooth communication module, used to realize dynamic control and data interaction functions for the entire device. The processing module can be a low-power, high-performance microprocessor unit, such as a 32-bit ARM architecture chip, with a preferred main frequency range of 48 MHz to 120 MHz to ensure real-time data processing. The processing module integrates a multi-channel PWM (Pulse Width Modulation) output interface, used to transmit the generated adjustment commands to the magnetic stimulation module 20 and the dynamic shielding layer module 30 in real time via PWM signals, realizing fine control of each coil unit and the dynamic shielding unit. The duty cycle, frequency, and other parameters of the PWM output can be dynamically set according to different treatment scenarios, with a typical frequency range of 1 Hz to 100 Hz, supporting custom pulse width and waveform.

[0054] The processing module also integrates multiple data acquisition interfaces, including analog input ports and digital bus interfaces, for receiving signal data from the electromyography electrode module 50, temperature probe module 60, and IMU module 70. Electromyography signals are amplified and converted from analog to digital before being input to the processing module, while temperature signals are similarly processed by the signal conditioning module before input. Attitude data from the IMU module 70, after Kalman filtering, is input via I2C or SPI bus to ensure stable data link and low latency. Based on the acquired real-time data, the processing module executes closed-loop control logic, dynamically generating control commands to achieve precise adjustment of the magnetic field output. It also features an anomaly detection function, triggering safety strategies when abnormal signals (such as overheating or signal loss) occur, ensuring the safe and reliable operation of the device.

[0055] The memory unit is used to store control programs, parameter configuration files, and historical treatment data. It is preferably configured with at least 128 KB of non-volatile memory and equipped with a data retention mechanism to prevent data loss during sudden power outages. The power management unit includes a low-dropout voltage regulator module, overvoltage and overcurrent protection circuits, and a battery power detection module. These provide a stable power supply to each functional unit and enable low-power sleep management.

[0056] The Bluetooth communication module adopts the Bluetooth Low Energy (BLE) standard and operates in the 2.4 GHz frequency band, enabling it to establish a stable wireless connection with user-end mobile control devices (such as mobile phones and tablets). The main functions of the Bluetooth communication module include: uploading the device's real-time operating status (such as current stimulation parameters, temperature, and motion status) to the user end via data packets, and receiving control commands issued by the user. Users can select preset treatment modes, adjust stimulation parameters, or initiate stop commands through a mobile application. Upon receiving the commands, the Bluetooth communication module transmits them to the processing module. The processing module parses the commands and outputs new control signals through the PWM interface based on the command content, thus realizing remote control functionality.

[0057] Through the above structural design, the control module 40 not only realizes the real-time acquisition and processing of various biological signals, but also has highly reliable closed-loop control capabilities and flexible wireless interaction functions, enabling the entire magnetic stimulation device to adapt to various complex usage scenarios and meet users' dual needs for precise stimulation and remote control.

[0058] Figure 3 This is a flowchart illustrating a method for controlling a wearable magnetic stimulation device for neurorehabilitation, according to one embodiment of the present invention. Figure 3 As shown, this invention provides a control method for a wearable magnetic stimulation device for neurorehabilitation, the method comprising: Step S10: Based on the processed data output by the IMU module 70, the spatial position and offset parameters of the device are parsed and used as motion parameters.

[0059] Specifically, the data output by the IMU module 70 includes three-axis angular velocity, three-axis acceleration, and three-axis magnetic field strength data. After processing by the Kalman filter algorithm, stable attitude calculation results can be obtained, including pitch angle, roll angle, yaw angle, and displacement changes of the device in three-dimensional space. The analysis process can convert the output data of the IMU module 70 into absolute spatial coordinates and relative motion vectors in real time through three-dimensional coordinate system mapping, thereby extracting the current spatial position and the offset relative to the initial target point. To ensure the real-time performance and accuracy of the data, the sampling period can be set from 10 ms to 50 ms to ensure continuous monitoring of the motion state in dynamic scenarios. The acquired motion parameters include spatial position coordinates (X, Y, Z), attitude angles, and instantaneous displacement velocity, which serve as the input basis for subsequent adjustments. Through this processing step, real-time monitoring of the device's motion state can be achieved, which is particularly suitable for highly dynamic scenarios such as rehabilitation training, effectively preventing stimulus offset problems caused by position changes.

[0060] Step S20: Based on the motion parameters, adjust the data acquisition strategy of the electromyography electrode module 50, and acquire the corresponding electromyography signal data based on the adjusted electromyography electrode module 50.

[0061] Specifically, when the motion parameter indicating device experiences significant shifts or changes in posture, the relative position of the electromyographic electrode array to the target muscle group may alter, affecting signal quality. To address this, the data acquisition strategy of the electromyographic electrode module 50 can be dynamically adjusted, such as changing the activated electrode channel, optimizing the sampling frequency (e.g., from 500 Hz to 1 kHz), or switching to nearby electrode pads for data acquisition. Data acquisition can employ a multi-parallel structure, simultaneously activating multiple electrode groups and automatically selecting the electrode data with the highest signal-to-noise ratio using a real-time feedback mechanism. This ensures high-quality electromyographic signals are acquired even under conditions of device movement or unstable wear, serving as the core input for closed-loop control. Furthermore, the acquisition strategy can be dynamically filtered based on the motion state to adapt to different muscle activity intensities, ensuring the reliability and stability of electrophysiological data.

[0062] Step S30: Extract features from the electromyographic signal data, identify the neural excitability level of the target region, and generate preliminary stimulation parameters based on the neural excitability level.

[0063] Specifically, the acquired electromyographic (EMG) signals are first pre-amplified, bandpass filtered, and digitized. Then, feature extraction algorithms are used to analyze their time-domain and frequency-domain characteristics, such as root mean square (RMS), integrated electromyography (iEMG), dominant frequency (MF), and waveform complexity. By setting feature thresholds or employing machine learning methods, the excitability state of the target region's nerves can be identified, such as resting, mildly activated, or highly activated states. Based on the identification results, the initial stimulation parameter generation logic can adjust the output intensity, pulse frequency, and activation mode of the magnetic stimulation. For example, when low nerve excitability is detected, the system can automatically increase the stimulation intensity to enhance the nerve response; conversely, when high excitability is detected, the stimulation frequency can be reduced or the stimulation interval extended to prevent overstimulation. This step ensures that the stimulation parameters can be adaptively optimized according to the real-time nerve state, improving the personalization and safety of treatment.

[0064] Step S40: Simultaneously receive the temperature data output by the temperature probe module 60, and combine the temperature data with the preliminary stimulation parameters to perform a safety check and temperature threshold verification, using the verification results as the basis for adjustment.

[0065] Specifically, temperature data is acquired via an NTC thermistor to monitor the surface temperature of the wearing area and potential hotspots in real time. The acquisition cycle is preferably 100 ms to 500 ms to achieve high-frequency thermal monitoring. During the safety check, the real-time temperature data is first compared with a set temperature threshold (e.g., 45°C), and a risk assessment is performed in conjunction with preliminary stimulation parameters (especially stimulation intensity and pulse width). If the detected temperature is close to or exceeds the threshold, the system can determine a potential overheating risk and trigger a power reduction mechanism or a pause in output strategy; if the temperature is within the safe range, the stimulation parameters remain unchanged. The temperature verification results are not only used for stimulation intensity adjustment but also for dynamically adjusting the focusing strategy of the shielding layer to control the distribution of local thermal effects and ensure thermal safety during long-term wear.

[0066] Step S50: Based on the adjustment basis, generate control instructions for the magnetic stimulation module 20.

[0067] Specifically, the control commands for the magnetic stimulation module 20 include any one or more of the following: activation state of each coil unit, output intensity, pulse frequency, and operating timing. Each coil unit can be individually set to activate or deactivate, enabling independent control of multiple blocks. The output intensity can be precisely controlled by adjusting the current amplitude of the drive circuit, typically ranging from 10 mT to 150 mT. The pulse frequency can be set from 1 Hz to 50 Hz according to treatment needs, supporting continuous wave or pulse wave modes. The operating timing defines the activation sequence and delay parameters of different coils, used to achieve path-by-path scanning or array-based collaborative modes. Commands are output through a PWM interface, driving the corresponding coil unit in real time to ensure precise stimulation coverage of the target nerve region, while also supporting mode switching in complex treatment scenarios.

[0068] Step S60: Simultaneously generate control instructions for the dynamic shielding module 30 based on the motion parameters and the stimulation requirements for setting.

[0069] Specifically, the control commands for the dynamic shielding layer module 30 include the focusing direction and / or shielding range of each dynamic shielding unit. Each dynamic shielding unit can be individually set with its magnetic field guiding angle and shielding range size to achieve local or overall focusing adjustment. The control logic first determines the current spatial offset direction and angle of the device based on motion parameters, and then, combined with the user-set target stimulation area, automatically calculates the optimal state that each dynamic shielding unit should adjust to. For example, when the device undergoes a certain angle of rotational offset, the dynamic shielding unit can adjust its focusing angle accordingly to compensate for the magnetic field deviation, ensuring that the stimulation energy is always aligned with the target area. This command is also output to the dynamic shielding layer drive module via a PWM or DAC interface, responding to motion changes in real time to achieve precise magnetic field control.

[0070] The present invention also provides a computer-readable storage medium storing instructions which, when executed on a computer, cause the computer to perform the above-described control method for a wearable magnetic stimulation device for neurorehabilitation.

[0071] Those skilled in the art will understand that all or part of the steps in the methods of the above embodiments can be implemented by a program instructing related hardware. This program is stored in a storage medium and includes several instructions to cause a microcontroller, chip, or processor to execute all or part of the steps of the methods described in the various embodiments of the present invention. The aforementioned storage medium includes various media capable of storing program code, such as a USB flash drive, a portable hard drive, a read-only memory (ROM), a random access memory (RAM), a magnetic disk, or an optical disk.

[0072] The optional embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the embodiments of the present invention are not limited to the specific details described above. Within the scope of the technical concept of the embodiments of the present invention, various simple modifications can be made to the technical solutions of the embodiments of the present invention, and these simple modifications all fall within the protection scope of the embodiments of the present invention. It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. To avoid unnecessary repetition, the embodiments of the present invention will not further describe the various possible combinations.

[0073] Furthermore, various different embodiments of the present invention can be combined in any way, as long as they do not violate the spirit of the embodiments of the present invention, they should also be regarded as the content disclosed by the embodiments of the present invention.

Claims

1. A wearable magnetic stimulation device for neurorehabilitation, characterized in that, The device comprises: a flexible circuit board module for supporting and connecting each functional module, being a flexible extensible structure; a magnetic stimulation module configured to generate a magnetic field to realize nerve stimulation, the magnetic stimulation module comprising a plurality of arrayed coil units, each coil unit being independently controllable to realize multi-zone targeted magnetic stimulation output; a dynamic shielding layer module arranged outside each coil unit, each coil unit being correspondingly provided with a dynamic shielding unit for limiting the magnetic field diffusion of the corresponding coil unit and enhancing the magnetic field focusing effect of the corresponding coil unit; a control module for dynamically adjusting the working states of the magnetic stimulation module and the dynamic shielding layer module.

2. The apparatus of claim 1, wherein, The flexible circuit board module is a multi-layer composite structure; The flexible circuit board comprises a polyimide base layer, a metal conductive circuit layer, and at least one polyimide protective layer; The edge area of the flexible circuit board module is provided with a folding gap and a reserved expansion port, and a grid-shaped stress release hole is formed on the circuit board, and the expansion port is electrically connected with the additional module through a plug-in connector.

3. The apparatus of claim 1, wherein, The magnetic stimulation module further comprises a drive circuit; The drive circuit comprises a programmable pulse generator, a power amplifier, and a coil selection switch; The drive circuit is configured to adjust the working state of each coil unit based on the control signal sent by the control module, and to monitor and correct the output magnetic field parameters in real time.

4. The apparatus of claim 1, wherein, The dynamic shielding layer module is a multi-layer stacked structure; The dynamic shielding layer module comprises a flexible magnetically conductive metal layer, an electrically controlled deformation layer, and an insulating buffer layer; The electrically controlled deformation layer is a polymer layer based on the electrostrictive effect, comprising at least one dielectric elastomer film and a matching flexible electrode layer to change the magnetic field guiding path of the magnetically conductive metal layer by deformation when a voltage is applied; The dynamic shielding layer module is electrically connected with the control module and adjusts the shielding area according to the control instructions sent by the control module.

5. The apparatus of claim 1, wherein, The device further comprises a myoelectric electrode module; The myoelectric electrode module is used to collect the myoelectric signals of the wearing area in real time and transmit the collected myoelectric signals to the control module, so that the control module uses the myoelectric signals as the dynamic shielding layer module The myoelectric electrode module comprises a plurality of electrode pieces, each electrode piece being arrayed and fixed to the surface of the flexible circuit board through a conductive adhesive layer and connected to a signal amplifier; The signal amplifier, the band-pass filter and the analog-to-digital conversion module in series form a signal acquisition module for collecting myoelectric signals.

6. The apparatus of claim 1, wherein, The device further comprises a temperature probe module for detecting the temperature change of the wearing area in real time and providing temperature data to the control module for the control module to perform overheat protection and safety adjustment; The temperature probe module is composed of a plurality of NTC thermistors; Each NTC thermistor is connected to a signal conditioning module through flexible wiring; The signal conditioning module comprises a voltage stabilizing power supply, a signal amplifier, and an A / D converter for collecting and digitizing the data of each temperature point; The signal conditioning module is also used to trigger power limitation or interrupt magnetic stimulation output when the detected temperature exceeds the set threshold.

7. The apparatus of claim 1, wherein, The device also comprises an IMU module for detecting the posture and motion state of the device and providing detection data to the control module; The IMU module comprises a multi-axis sensor chip, which is integrated with a three-axis gyroscope, a three-axis accelerometer and a three-axis magnetometer, for real-time collection of three-axis angular velocity, three-axis acceleration and three-axis magnetic field data as detection data; The IMU module further comprises a low-power micro control unit configured with a Kalman filter algorithm for real-time calculation of spatial pose and micro displacement data of the device, and sending the processed data to the control module for dynamic compensation control by the control module.

8. The apparatus of claim 1, wherein, The control module comprises a processing module, a memory unit, a power management unit and a Bluetooth communication module; The processing module is configured to generate real-time adjustment instructions based on the collected electromyographic signals, temperature signals and processed data of the IMU module, and output control signals to the magnetic stimulation module and the dynamic shielding layer module through the PWM interface; The Bluetooth communication module is in communication connection with the user's mobile control terminal, for uploading the real-time working state of the device to the user terminal, and for transmitting the control instructions issued by the user to the processing module, so that the processing module outputs control signals to the magnetic stimulation module and the dynamic shielding layer module through the PWM interface based on the control instructions issued by the user. 9.A control method of a wearable magnetic stimulation device for neurorehabilitation, characterized in that, The method is applied to the wearable magnetic stimulation device for neural rehabilitation of any one of claims 1-8, the method is executed by the control module, and the method comprises: Based on the processed data output by the IMU module, the spatial position and offset parameters of the device are analyzed as motion parameters; Based on the motion parameters, the data acquisition strategy of the electromyographic electrode module is adjusted, and the corresponding electromyographic signal data is collected based on the adjusted electromyographic electrode module; The electromyographic signal data is subjected to feature extraction, the neural excitability level of the target region is identified, and preliminary stimulation parameters are generated based on the neural excitability level; Meanwhile, the temperature data output by the temperature probe module is received, and the temperature data is combined with the preliminary stimulation parameters to perform safety check and temperature threshold check, and the inspection results are used as the adjustment basis; Based on the adjustment basis, control instructions of the magnetic stimulation module are generated; wherein, The control instructions of the magnetic stimulation module include any one or more of the activation state, output intensity, pulse frequency and working time sequence of each coil unit; Meanwhile, control instructions of the dynamic shielding layer module are generated according to the motion parameters and the set stimulation requirements; wherein, The control instructions of the dynamic shielding layer module include the focusing direction and / or shielding range of each dynamic shielding unit.

10. A computer-readable storage medium, characterized in that, The computer readable storage medium stores instructions, which when executed on a computer, cause the computer to execute the control method of the wearable magnetic stimulation device for neural rehabilitation of claim 9.

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