Electrical stimulation physiotherapy device based on multi-mode multi-point stimulation

Abstract

The invention discloses an electrical stimulation physiotherapy device based on multi-mode multi-point stimulation, and the device comprises a control module which is used for determining a physiotherapy mode corresponding to a user, and outputting a control instruction according to the physiotherapy mode; and the at least two electrode modules are connected to the control module, are arranged in a cortex stimulation area and a spinal cord stimulation area of the user, and are used for synchronously outputting current to a plurality of stimulation target spots of the cortex stimulation area and the spinal cord stimulation area according to the control instruction so as to realize collaborative physiotherapy. Therefore, the multiple electrode modules arranged in the cortex area and the spinal cord area can be controlled according to different physiotherapy modes based on the control module, so that multi-mode and multi-target synchronous synergistic electrical stimulation physiotherapy is realized, and the intelligent degree and the treatment effect of the overall electrical stimulation physiotherapy are improved.

Description

Technical Field

[0001] This invention relates to the field of physiotherapy device technology, and in particular to an electrostimulation physiotherapy device based on multi-mode multi-point stimulation. Background Technology

[0002] Treatment of certain neurological disorders requires the introduction of physical neuromodulation therapy. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that primarily affects upper and lower motor neurons in the cerebral cortex, brainstem, and spinal cord, leading to muscle weakness, atrophy, difficulty swallowing, and respiratory failure. Currently, there is no cure. Existing drugs such as riluzole and edaravone can only partially slow disease progression, and their applicability is limited with significant side effects. Therefore, non-pharmacological, non-invasive physical neuromodulation therapy has become a research focus, aiming to alleviate symptoms and slow disease progression by regulating neural excitability and promoting neural plasticity.

[0003] Existing neuromodulation technologies are mainly divided into two categories:

[0004] 1. Transcranial direct current stimulation (tDCS): This method modulates the excitability of the cerebral cortex by applying a weak direct current (usually 1-2 mA) through scalp electrodes. For example, Di Lazzaro et al. used unilateral motor cortex tDCS (1 mA) to treat ALS patients, but the effect was limited, only slightly improving some motor functions. Most similar studies target single cortical points, neglecting the involvement of spinal motor neurons and failing to comprehensively modulate the damaged neural pathways in ALS.

[0005] 2. High-precision transcranial electrical stimulation (HD-tES): This method uses a multi-electrode array to achieve more focused cortical stimulation, but it is still limited to brain regions and does not involve the spinal cord. For example, previous cortical stimulation studies by Benussi et al. showed potential benefits for ALS, but the stimulation target was singular.

[0006] Clearly, most existing technologies suffer from single stimulation targets and fail to consider the synergistic stimulation of the cortical-spinal cord pathway, thus failing to form a closed-loop neuromodulation circuit and limiting the full realization of therapeutic potential. Therefore, existing technologies have shortcomings that urgently need to be addressed. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide an electrostimulation therapy device based on multi-mode and multi-point stimulation, which can control multiple electrode modules set in the cortical and spinal cord regions according to different therapy modes based on the control module, so as to realize synchronous and synergistic electrostimulation therapy with multiple modes and multiple targets, thereby improving the intelligence level and therapeutic effect of the overall electrostimulation therapy.

[0008] To address the aforementioned technical problems, the first aspect of this invention discloses an electrostimulation therapy device based on multi-mode, multi-point stimulation, the device comprising: The control module is used to determine the user's corresponding physiotherapy mode and output control commands according to the physiotherapy mode; At least two electrode modules connected to the control module are disposed in the user's cortical stimulation area and spinal cord stimulation area, and are used to synchronously output current to multiple stimulation target points in the cortical stimulation area and the spinal cord stimulation area according to the control command to achieve synergistic physiotherapy.

[0009] As an optional implementation, the electrode module disposed in the cortical stimulation area and the electrode module disposed in the spinal cord stimulation area have opposite polarities in their output currents during operation.

[0010] As an optional implementation, the physiotherapy mode is a cortical-spinal cord mode or a spinal cord-cortical mode.

[0011] As an optional implementation, the cortical-spinal pattern is used to indicate the flow of current from the cortical stimulation area to the spinal cord stimulation area.

[0012] As an optional implementation, the spinal cord-cortical pattern is used to indicate the flow of current from the spinal cord stimulation area to the cortical stimulation area.

[0013] As an optional implementation, the cortical-spinal cord pattern is a first single-to-single pattern, a first double-to-single pattern, a first single-to-double pattern, or a first double-to-double pattern; the spinal cord-cortex pattern is a second single-to-single pattern, a second double-to-single pattern, a second single-to-double pattern, or a second double-to-double pattern.

[0014] As an optional implementation, the first one-to-one mode or the second one-to-one mode is used to indicate that the electrode module disposed in the cortical stimulation area is a single channel and the electrode module disposed in the spinal cord stimulation area is a single channel. The first dual-to-single mode or the second dual-to-single mode is used to indicate that the electrode module disposed in the cortical stimulation area is dual-channel and the electrode module disposed in the spinal cord stimulation area is single-channel. The first single-to-dual mode or the second single-to-dual mode is used to indicate that the electrode module disposed in the cortical stimulation area is a single channel and the electrode module disposed in the spinal cord stimulation area is a dual channel. The first pair-to-pair mode or the second pair-to-pair mode is used to indicate that the electrode module disposed in the cortical stimulation area is dual-channel and the electrode module disposed in the spinal cord stimulation area is dual-channel.

[0015] As an optional implementation, the cortical stimulation area is the motor cortex of the brain; the motor cortex is the C3 region or the C4 region.

[0016] As an optional implementation, the spinal cord stimulation area is the cervical spinal cord area or the lumbosacral spinal cord area; the cervical spinal cord area is the C5-C6 segment area or the C7-T1 segment area; the lumbosacral spinal cord area is the T11-T12 segment area or the L1-L2 segment area.

[0017] As an optional implementation, the device further includes: A signal generation module corresponding to the electrode module is connected to both the corresponding electrode module and the control module, and is used to generate a voltage signal according to the control command of the control module to drive the electrode module to output current. A clock management module, connected to all the signal generation modules, is used to output independent differential clock signals to each of the signal generation modules based on a preset external reference clock signal. The control module contains executable code for performing the following steps: The control command is sent in parallel to all the signal generation modules to drive each of the signal generation modules to generate the voltage signal based on the shared clock signal point corresponding to the differential clock signal, so as to drive the electrode module to output current, and make the synchronization timing error between the output currents of all the electrode modules less than 1 microsecond.

[0018] Compared with the prior art, the present invention has the following beneficial effects: This invention discloses an electrostimulation therapy device based on multi-mode, multi-point stimulation. The device includes: a control module for determining the user's corresponding therapy mode and outputting control commands according to the therapy mode; and at least two electrode modules connected to the control module, disposed in the user's cortical stimulation area and spinal cord stimulation area, for synchronously outputting current to multiple stimulation target points in the cortical and spinal cord stimulation areas according to the control commands to achieve synergistic therapy. Therefore, this invention can control multiple electrode modules disposed in the cortical and spinal cord areas according to different therapy modes based on the control module, to achieve synchronous and synergistic electrostimulation therapy with multiple modes and multiple targets, improving the overall intelligence and therapeutic effect of electrostimulation therapy. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the functional modules of an electrostimulation therapy device based on multi-mode multi-point stimulation disclosed in an embodiment of the present invention; Figure 2 This is a schematic diagram of the system architecture of a home-use wearable cortical-spinal synchronous electrical stimulation device for treating amyotrophic lateral sclerosis (ALS), as disclosed in an embodiment of the present invention. Detailed Implementation

[0021] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] The terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this invention are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, apparatus, product, or end that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or ends.

[0023] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of the invention. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0024] Example 1 Please see Figure 1 , Figure 1 This is a functional module diagram of an electrostimulation therapy device based on multi-mode, multi-point stimulation disclosed in an embodiment of the present invention. Figure 1As shown, the electrostimulation therapy device based on multi-mode multi-point stimulation includes a control module 10 and at least two electrode modules 20 connected to the control module 10.

[0025] Specifically, the control module 10 is used to determine the user's corresponding physiotherapy mode and output control commands according to the physiotherapy mode.

[0026] Specifically, the electrode module 20 is set in the user's cortical stimulation area and spinal cord stimulation area, and is used to synchronously output current to multiple stimulation target points in the cortical stimulation area and the spinal cord stimulation area according to the control command to achieve synergistic physiotherapy.

[0027] Optionally, the control module 10 is an AT32F403ACGT7 chip based on the ARM Cortex-M4F core.

[0028] The above scheme enables the control module to control multiple electrode modules set in the cortical and spinal cord regions according to different physiotherapy modes, thereby achieving multi-mode, multi-target synchronous and synergistic electrical stimulation physiotherapy, improving the overall intelligence and therapeutic effect of electrical stimulation physiotherapy.

[0029] As an optional embodiment, the electrode module 20 disposed in the cortical stimulation area and the electrode module 20 disposed in the spinal cord stimulation area have opposite polarities in their output currents during operation.

[0030] The above scheme enables current flow between the cortical and spinal cord regions by using electrode modules with opposite current polarities, thereby achieving synchronous and synergistic electrical stimulation therapy through different current pathways, and improving the overall intelligence and therapeutic effect of electrical stimulation therapy.

[0031] As an optional embodiment, the physiotherapy mode is a cortical-spinal cord mode or a spinal cord-cortical mode.

[0032] Specifically, this cortical-spinal cord pattern is used to indicate the flow of electrical current from the cortical stimulation area to the spinal cord stimulation area.

[0033] Specifically, this spinal cord-cortical pattern is used to indicate the flow of electrical current from the spinal cord stimulation area to the cortical stimulation area.

[0034] Optionally, the cortico-spinal pattern can be a first single-to-single pattern, a first double-to-single pattern, a first single-to-double pattern, or a first double-to-double pattern.

[0035] Optionally, the spinal cord-cortex can be a second single-to-single pattern, a second double-to-single pattern, a second single-to-double pattern, or a second double-to-double pattern.

[0036] Optionally, the first one-to-one mode or the second one-to-one mode is used to indicate that the electrode module 20 located in the cortical stimulation area is a single channel and the electrode module 20 located in the spinal cord stimulation area is a single channel.

[0037] Optionally, the first dual-to-single mode or the second dual-to-single mode is used to indicate that the electrode module 20 disposed in the cortical stimulation area is dual-channel and the electrode module 20 disposed in the spinal cord stimulation area is single-channel.

[0038] Optionally, the first single-to-dual mode or the second single-to-dual mode is used to indicate that the electrode module 20 located in the cortical stimulation area is a single channel and the electrode module 20 located in the spinal cord stimulation area is a dual channel.

[0039] Optionally, the first pair-to-pair mode or the second pair-to-pair mode is used to indicate that the electrode module 20 disposed in the cortical stimulation area is dual-channel and the electrode module 20 disposed in the spinal cord stimulation area is dual-channel.

[0040] Optionally, the cortical stimulation area is the motor cortex of the brain.

[0041] Optionally, the motor cortex region of the brain may be region C3 or region C4.

[0042] Optionally, the spinal cord stimulation area can be the cervical spinal cord region or the lumbosacral spinal cord region.

[0043] Optionally, the cervical spinal cord region may be the C5-C6 segment region or the C7-T1 segment region.

[0044] Optionally, the lumbosacral spinal cord region can be the T11-T12 segment region or the L1-L2 segment region.

[0045] The above scheme limits the specific circuit control functions of different physiotherapy modes, enabling the scheme to achieve comprehensive and intelligent electrical stimulation physiotherapy with different numbers of channels from the cortical area to the spinal cord area or in the opposite direction. This allows for more functions and electrical stimulation physiotherapy for more diseases, improving the overall intelligence and therapeutic effect of electrical stimulation physiotherapy.

[0046] As an optional embodiment, the device further includes: A signal generation module 30 corresponding to the electrode module 20 is connected to both the corresponding electrode module 20 and the control module 10. It is used to generate a voltage signal according to the control command of the control module 10 to drive the electrode module 20 to output current. The clock management module 40 is connected to all the signal generation modules 30 and is used to output independent differential clock signals to each of the signal generation modules 30 based on a preset external reference clock signal.

[0047] Specifically, the control module 10 contains executable code to perform the following steps: The control command is sent in parallel to all the signal generation modules 30 to drive each signal generation module 30 to generate the voltage signal based on the shared clock signal point corresponding to the differential clock signal, so as to drive the electrode module 20 to output current, and make the synchronization timing error between the output currents of all electrode modules 20 less than 1 microsecond.

[0048] Optionally, the clock management module 40 is a CDCE6214 clock management chip.

[0049] Optionally, the signal generation module 30 includes an AT32F403ACGT7 MCU chip and an NE5532M / TR operational amplifier.

[0050] The above scheme enables the clock management module to output an independent differential clock signal based on the reference clock signal, allowing the signal generation module to drive the electrode module to output a more synchronized stimulation current. This achieves more precise synchronous and synergistic electrical stimulation therapy, improving the overall intelligence and therapeutic effect of the electrical stimulation therapy.

[0051] Furthermore, based on the technical solution disclosed in this embodiment, a home-use wearable cortico-spinal synchronous electrical stimulation device for treating amyotrophic lateral sclerosis (ALS) has been realized. It adopts an integrated handheld main unit and a detachable electrode design. For a detailed functional module diagram, please refer to... Figure 2 .

[0052] Specifically, the device is equipped with four Type-C interface-based stimulation output channels for connecting two sets of cortical electrodes and two sets of spinal electrodes. The cortical electrodes are precisely located in the C3 / C4 motor cortex area of ​​the International 10-20 system using an EEG cap, while the spinal electrodes are applied to the body surface areas corresponding to the C5-C6 and C7-T1 spinal cord segments in the neck.

[0053] Specifically, the device has eight built-in standard ALS treatment modes: four are descending regulation pathways from the cortex to the spinal cord, and four are ascending regulation pathways from the spinal cord to the cortex.

[0054] During treatment, users can select preset programs via the local LCD display and function buttons. The system automatically loads the corresponding electrode polarity configuration, stimulation intensity (default 2mA / channel), and duration (30 minutes). All modes support personalized intensity adjustment within a safe range. After system startup, a multi-electrode impedance self-check is automatically performed. If an impedance abnormality is detected, an adjustment prompt is given in real time. During stimulation, the system continuously performs multiple safety monitoring of impedance, current, and temperature, immediately interrupting the output if an abnormality is detected. The entire stimulation process is equipped with a 30-second fixed-duration current fade-in / fade-out program to ensure safe and comfortable treatment. The core innovation of this device lies in its unique bidirectional control architecture, which uses microsecond-level synchronization technology to ensure the temporal consistency of cortical and spinal cord stimulation, constructing a complete "cortical-spinal cord" neural control circuit in vivo to achieve synergistic treatment of amyotrophic lateral sclerosis (ALS).

[0055] The overall architecture of the device is as follows: Figure 2 As shown, it consists of the following five highly synergistic core subsystems, which work together to achieve precise and safe cortical-spinal cord synchronous electrical stimulation: 1. The interactive control subsystem integrates an LCD display screen and multi-functional physical buttons, providing users with an intuitive interface for parameter settings, status display, and operation feedback, enabling full-process visual interaction during treatment.

[0056] 2. The BMS (Battery Management System) adopts a collaborative architecture of the BQ27220 power monitoring chip and the DW01 protection chip. This solution provides high-precision power monitoring of ±1%, displaying the remaining usage time in real time on an LCD screen. It also features triple hardware protection functions against overcharge, over-discharge, and short circuit, with a response time of <50ms and standby power consumption of <10μA, ensuring safe operation and long standby time in a home environment. It is responsible for the system's energy management and safety assurance, realizing intelligent charge and discharge control, power monitoring, and multiple circuit protection functions to ensure long-term reliable operation of the device in a home environment.

[0057] 3. Dual-channel electrical stimulation generation subsystem, comprising two independent electrical stimulation generation units: Cortical electrical stimulation unit: It adopts a dedicated MCU, which generates a preset stimulation waveform through its internal dual-channel DAC, converts it into a precise current signal through a voltage-controlled constant current source, and outputs it to the bilateral motor cortex (C3 / C4). Spinal cord electrical stimulation unit: adopts the same architecture, and outputs synchronous current signals to the cervical spinal cord (C5-C6 / C7-T1) through an independent MCU and dual-channel DAC. Specifically, both units integrate real-time impedance detection circuits to achieve electrode detachment monitoring and dynamic safety protection.

[0058] Specifically, the cortical electrical stimulation subsystem employs a voltage-controlled constant current source constructed from an AT32F403ACGT7 MCU and an NE5532M / TR operational amplifier. The MCU's built-in 12-bit dual-channel DAC provides precise stimulation waveforms, while the low-noise characteristics of the NE5532M / TR (≤5nV / √Hz) ensure a clean and stable current output, achieving μs-level synchronous stimulation of both bilateral motor cortices with a synchronization error of <1μs.

[0059] Specifically, the spinal cord stimulation subsystem adopts the same hardware architecture, using an independent AT32F403ACGT7 MCU and NE5532M / TR operational amplifier to achieve dual-target stimulation of the cervical spinal cord. The system supports adjustable current output of 0-4mA with a resolution of 1μA, integrates real-time impedance detection and multiple safety monitoring, and has an abnormal response time of <100μs, ensuring the safety and reliability of spinal cord stimulation.

[0060] 4. The main control synchronization subsystem is based on the AT32F403ACGT7 high-performance MCU with an ARM Cortex-M4F core. This chip operates at a frequency of up to 240MHz, integrates a hardware floating-point unit, and can process dual-channel stimulation data in real time and execute safety monitoring algorithms. Its rich communication interfaces ensure that it can coordinate the synchronous operation of the cortical and spinal cord stimulation units and manage the user interface. It serves as the system's control center, implementing the following core functions: High-precision coordinated control of cortical and spinal cord stimulation units; Manage the human-computer interaction interface and system operation logic.

[0061] 5. A high-precision clock synchronization system employs a unified master clock source and hardware triggering mechanism to ensure that the timing synchronization error between the main control MCU, the cortical stimulation MCU, and the spinal stimulation MCU is less than 1 microsecond. This provides a fundamental guarantee for the spatiotemporal consistency of multi-target stimulation. Specifically, it uses the CDCE6214 clock management chip as its core, generating four independent low-jitter (<100fs) LVDS differential clock signals based on a 25MHz reference clock. This design provides a unified and accurate time base for each MCU within the system, ensuring that the synchronization timing error between the cortical and spinal stimulation subsystems is less than 1 microsecond, thus guaranteeing the spatiotemporal consistency of multi-target stimulation.

[0062] More specifically, the system pre-sets the following eight standardized treatment combinations: 1. Cortex → Spinal Cord Pathway (Descending Regulation): Cortical single-channel anode / spinal cord single-channel cathode; Cortical dual-channel anode / spinal cord single-channel cathode; Cortical single-channel anode / spinal cord dual-channel cathode; Cortical dual-channel anode / spinal cord dual-channel cathode; 2. Spinal cord → cortical pathway (ascending regulation): Cortical single-channel cathode / spinal cord single-channel anode; Cortical dual-channel cathode / spinal cord single-channel anode; Cortical single-channel cathode / spinal cord dual-channel anode; Cortical dual-channel cathode / spinal cord dual-channel anode; Specifically, the association analysis between the therapeutic targets of the above pathways and the improvement of ALS symptoms is as follows: The cortical-spinal cord pathway primarily targets upper motor neuron dysfunction in ALS. Anodic stimulation of the motor cortex enhances cortical excitability and improves the quality of motor command output; simultaneously, cathodic stimulation inhibits excessive spinal cord excitation, reducing muscle tone and spasticity. This pathway is particularly effective in improving fine motor control and alleviating muscle rigidity.

[0063] The spinal cord-cortical pathway primarily targets lower motor neuron degeneration. It enhances the viability and electrical activity of spinal motor neurons through anodic stimulation, while simultaneously inhibiting cortical overexcitation and balancing abnormal output from the corticospinal tract. This pathway is particularly effective in delaying muscle atrophy, improving muscle strength maintenance, and reducing fasciculations.

[0064] Furthermore, in addition to the aforementioned cortical-cervical spinal cord combined regulation system, it can also be extended to lumbosacral spinal cord-cortical synergistic regulation, providing ALS patients with a more comprehensive lower limb motor function rehabilitation program: 1. Localization and physiological basis of lumbosacral spinal cord stimulation: T11-T12 segment: Corresponds to the head of the lumbosacral enlargement. Stimulation of this area preferentially activates proximal muscle groups such as hip flexion and extension, mainly improving postural control and gross motor function. L1-L2 segments: corresponding to the caudal end of the lumbosacral enlargement. Stimulation of this area preferentially activates distal muscle groups such as ankle flexion and extension, mainly improving gait control and fine motor function.

[0065] 2. Anatomical correspondences of lower limb regulation: Proximal muscle group: mainly includes muscles around the hip and knee joints such as rectus femoris (VL) and semitendinosus (MH), which are responsible for maintaining body position and basic movement; Distal muscle groups: mainly include muscles around the ankle joint such as the tibialis anterior (TA) and soleus (SOL), which are responsible for gait refinement and balance regulation.

[0066] 3. System expansion implementation plan: Multiple stimulation configurations are supported through interchangeable electrode modules: Upper limb emphasis pattern: using a combination of C3 / C4 cortex and C5-C6 / C7-T1 cervical spinal cord; Lower limb emphasis pattern: using a combination of C3 / C4 cortex and T11-T12 / L1-L2 lumbosacral spinal cord; Full-body integrated mode: achieves alternating stimulation of the upper and lower limbs through time-sharing reuse.

[0067] 4. Expansion of technological advantages: This expanded approach enables a single device to meet the treatment needs of ALS patients at different stages of the disease: in the early stages, the focus is on maintaining upper limb function, while in the middle and late stages, the core is on protecting lower limb function and preventing falls. Eight basic treatment modes can be flexibly adapted to different combinations of stimulation targets, forming a complete ALS neurological rehabilitation system.

[0068] 5. Clinical significance: Through the synergistic regulation of the lumbosacral spinal cord and cortex, the proximal and distal muscle function of the lower limbs in ALS patients can be improved in a targeted manner, the decline of lower limb motor function can be delayed, and mobility and self-care ability can be improved, providing a new technical approach for the comprehensive rehabilitation of ALS.

[0069] Specifically, the system's workflow includes: 1. Treatment preparation stage: Device wearing: The user first puts the headband on the head, ensuring that the two electrodes accurately cover the C3 and C4 positions (bilateral motor cortex) of the international 10-20 system. Then, the neck strap unit is worn, so that the two electrodes are stably attached to the C5-C6 and C7-T1 spinal cord segments at the back of the neck, respectively.

[0070] Power-on and Self-test: Press the "Power On / Off" button on the main control box to start the device. The system automatically performs a power-on self-test, checking the battery level and circuit status, and quickly scans the contact quality between all electrodes and the skin using the impedance detection module. The system also automatically detects and confirms the electrode polarity configuration. If the impedance value exceeds the safe range (>5kΩ), the LCD display will provide a clear adjustment prompt.

[0071] Mode Selection and Parameter Confirmation: Users can cycle through eight preset ALS treatment modes (including four cortical-spinal cord pathways and four spinal cord-cortical pathway configurations) using the "Mode" button. After selecting a mode, the system automatically loads the corresponding clinically validated parameters (including electrode polarity configuration, 2mA constant current output, 30-minute duration, etc.). Users can make personalized fine-tuning within a safe range using the "Intensity +" and "Intensity -" buttons according to individual tolerance.

[0072] 2. Treatment Implementation Phase: One-button start and current fade-in: The user presses the "Start / Pause" button to initiate treatment. The system performs a 30-second current fade-in process, gradually and linearly increasing the current from zero to the target intensity. This safety design effectively avoids the impact of sudden current changes on the nervous system, significantly improving treatment comfort and compliance.

[0073] Steady-state stimulation and real-time monitoring: During the 30-minute stimulation process, the device maintains a precise constant current output to ensure continuous and stable regulation of the cortical-spinal cord pathway. The system simultaneously performs multiple safety monitoring functions. Continuous impedance monitoring ensures electrode contact stability; Real-time current precision control ensures output stability; Temperature monitoring to prevent localized overheating; Polarity monitoring ensures the correct execution of treatment modalities.

[0074] Abnormal Handling: If the monitoring system detects any abnormality (such as electrode detachment, impedance abnormality, polarity error), the device will immediately and automatically pause stimulation and alert the user through audiovisual alarms to ensure treatment safety.

[0075] 3. Treatment Completion and Data Management Phase: Current fade-out and treatment completion: After 30 minutes of treatment, the system performs a 30-second current fade-out process, gradually reducing the current from the target intensity to zero, thus completing the treatment cycle. Users can also manually pause the treatment at any time as needed.

[0076] Data recording and storage: After the treatment is completed, the system automatically records the key data of this treatment, including the selected treatment mode, actual stimulation parameters, average impedance value, abnormal event records, etc., and stores them in the internal memory.

[0077] Equipment Maintenance and Data Application: Users charge the device via the Type-C interface. Complete treatment data can be exported through this interface, providing objective evidence for medical professionals to evaluate treatment effectiveness and adjust treatment plans, enabling personalized precision treatment based on clinical evidence.

[0078] In summary, the above-disclosed solutions possess the following innovative features: 1. Multi-target synchronous stimulation system architecture for ALS treatment: Protect the dual-target synergistic stimulation protocol for the treatment of amyotrophic lateral sclerosis (ALS), including electrode placement schemes and hardware system architecture that simultaneously stimulate bilateral motor cortex (C3 / C4 location) and specific segments of cervical spinal cord (C5-C6 and C7-T1 regions), forming a complete "cortical-spinal cord" regulatory circuit.

[0079] 2. A bidirectional eight-mode regulatory mechanism based on ALS pathological characteristics: The protection includes eight treatment modalities specifically designed for the pathological characteristics of ALS involving both upper and lower motor neurons. These modalities include configuration schemes, selection methods, and execution logic for four descending "cortex → spinal cord" regulatory pathways and four ascending "spinal cord → cortex" regulatory pathways.

[0080] 3. Integrated solution for home-use wearable ALS treatment devices: The specific implementation plan for integrating a multi-target synchronous stimulation system into a home wearable device includes the mechanical structure, connection method, and human-computer interaction design of the head unit, neckband unit, and portable main control box, ensuring safe operation by non-professionals.

[0081] 4. ALS Personalized Treatment Parameter Configuration and Efficacy Evaluation System: It protects individualized treatment plans for different stages and symptom characteristics of ALS, including the selection logic of eight standard treatment modes, parameter adjustment range (current intensity adjustable from 0-4mA), and efficacy evaluation methods based on treatment data.

[0082] The device embodiments described above are merely illustrative. The modules described as separate components may or may not be physically separate. The components shown as modules may or may not be physical modules; that is, they may be located in one place or distributed across multiple network modules. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs. Those skilled in the art can understand and implement this without any creative effort.

[0083] Through the detailed description of the above embodiments, those skilled in the art can clearly understand that each implementation method can be implemented by means of software plus necessary general-purpose hardware platforms, and of course, it can also be implemented by hardware. Based on this understanding, the above technical solutions, in essence or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product can be stored in a computer-readable storage medium, including read-only memory (ROM), random access memory (RAM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), one-time programmable read-only memory (OTPROM), electrically-erasable programmable read-only memory (EEPROM), compact disc read-only memory (CD-ROM) or other optical disc storage, disk storage, magnetic tape storage, or any other computer-readable medium that can be used to carry or store data.

[0084] Finally, it should be noted that the electrostimulation therapy device based on multi-mode multi-point stimulation disclosed in the embodiments of the present invention is only a preferred embodiment of the present invention and is only used to illustrate the technical solution of the present invention, not to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. An electrostimulation therapy device based on multi-mode, multi-point stimulation, characterized in that, The device includes: The control module is used to determine the user's corresponding physiotherapy mode and output control commands according to the physiotherapy mode; At least two electrode modules connected to the control module are disposed in the user's cortical stimulation area and spinal cord stimulation area, and are used to synchronously output current to multiple stimulation target points in the cortical stimulation area and the spinal cord stimulation area according to the control command to achieve synergistic physiotherapy.

2. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 1, characterized in that, The electrode modules located in the cortical stimulation area and the electrode modules located in the spinal cord stimulation area have opposite polarities in their output currents during operation.

3. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 1, characterized in that, The physiotherapy mode is either cortical-spinal cord mode or spinal cord-cortical mode.

4. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 3, characterized in that, The cortical-spinal pattern is used to indicate the flow of electrical current from the cortical stimulation area to the spinal cord stimulation area.

5. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 3, characterized in that, The spinal cord-cortical pattern is used to indicate the flow of electrical current from the spinal cord stimulation area to the cortical stimulation area.

6. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 3, characterized in that, The cortical-spinal cord pattern is a first single-to-single pattern, a first double-to-single pattern, a first single-to-double pattern, or a first double-to-double pattern; the spinal cord-cortex pattern is a second single-to-single pattern, a second double-to-single pattern, a second single-to-double pattern, or a second double-to-double pattern.

7. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 6, characterized in that, The first one-to-one mode or the second one-to-one mode is used to indicate that the electrode module disposed in the cortical stimulation area is a single channel and the electrode module disposed in the spinal cord stimulation area is a single channel. The first dual-to-single mode or the second dual-to-single mode is used to indicate that the electrode module disposed in the cortical stimulation area is dual-channel and the electrode module disposed in the spinal cord stimulation area is single-channel. The first single-to-dual mode or the second single-to-dual mode is used to indicate that the electrode module disposed in the cortical stimulation area is a single channel and the electrode module disposed in the spinal cord stimulation area is a dual channel; The first pair-to-pair mode or the second pair-to-pair mode is used to indicate that the electrode module disposed in the cortical stimulation area is dual-channel and the electrode module disposed in the spinal cord stimulation area is dual-channel.

8. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 1, characterized in that, The cortical stimulation area is the motor cortex of the brain; the motor cortex is either region C3 or region C4.

9. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 1, characterized in that, The spinal cord stimulation area is the cervical spinal cord area or the lumbosacral spinal cord area; the cervical spinal cord area is the C5-C6 segment area or the C7-T1 segment area; the lumbosacral spinal cord area is the T11-T12 segment area or the L1-L2 segment area.

10. The electrostimulation therapy device based on multi-mode multi-point stimulation according to claim 1, characterized in that, The device further includes: A signal generation module corresponding to the electrode module is connected to both the corresponding electrode module and the control module, and is used to generate a voltage signal according to the control command of the control module to drive the electrode module to output current. A clock management module, connected to all the signal generation modules, is used to output independent differential clock signals to each of the signal generation modules based on a preset external reference clock signal. The control module contains executable code for performing the following steps: The control command is sent in parallel to all the signal generation modules to drive each of the signal generation modules to generate the voltage signal based on the shared clock signal point corresponding to the differential clock signal, so as to drive the electrode module to output current, and make the synchronization timing error between the output currents of all the electrode modules less than 1 microsecond.

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