Multi-channel electric potential grading output electric stimulation therapeutic instrument and control method thereof

Abstract

The application relates to the technical field of medical instrument nerve rehabilitation, and discloses a multi-channel electric potential grading output electric stimulation therapeutic instrument and a control method thereof, which comprises a host computer, a control unit, an electric stimulation generation module and multiple output ports. The multi-channel electric potential grading output electric stimulation therapeutic instrument and the control method thereof utilize multi-channel grading electric potential and time sequence programming setting, each stimulation channel adopts three-wire pulse technology, left and right electric potential translation is realized through setting of a common terminal, three different intensity levels of electric stimulation signals of low electric potential, medium electric potential and high electric potential can be independently output, multi-muscle group synchronous linkage stimulation is realized, poor stimulation scheme adaptability is prevented, time sharing or real-time combination through different output terminals is realized, sequential or synchronous linkage stimulation of multiple actions is realized, rehabilitation electric stimulation precision is greatly improved, scheme local storage and calling are simultaneously supported, and rehabilitation scheme reuse efficiency is effectively improved.

Description

Technical Field

[0001] This invention relates to the field of medical device neurorehabilitation technology, specifically to a multi-channel potential graded output electrical stimulation therapy device and its control method. Background Technology

[0002] Functional electrical stimulation (FESPS) is a mainstream treatment for limb function rehabilitation in patients with central nervous system injuries such as stroke and spinal cord injury. It relies on electrical pulses to stimulate neuromuscular tissue, assisting damaged muscle groups in completing active motor reconstruction. It is widely used in limb function training such as foot dorsiflexion, hand grasping, and joint flexion and extension. Currently, conventional electrical stimulation rehabilitation devices on the market mainly rely on output electrodes to release fixed-intensity electrical signals, using external electrode patches to stimulate single muscle sites.

[0003] Functional electrical stimulation is a common method for limb rehabilitation after central nervous system injury. Traditional electrical stimulation therapy devices have a limited number of output channels and fixed configurations, and most only support single-channel or dual-channel output. They cannot simultaneously stimulate multiple target muscle groups in the upper and lower limbs, making it difficult to achieve combined rehabilitation training for multiple movements such as foot dorsiflexion and hand grasping. Each channel lacks independent graded potential output capability and does not have time-sequential collaborative programming function, making it impossible to simulate the natural limb coordinated force exertion sequence. The clinical adaptability of combined stimulation of multiple sites is poor, thus reducing the efficiency of reusing rehabilitation programs.

[0004] Therefore, a multi-channel potential graded output electrical stimulation therapy device and its control method are proposed to solve the above-mentioned problems. Summary of the Invention

[0005] Technical problems to be solved

[0006] To address the shortcomings of existing technologies, this invention provides a multi-channel potential graded output electrical stimulation therapy device and its control method, which solves the problems of traditional electrical stimulation therapy devices having a small number of channels, fixed output configuration, inability to simultaneously conduct multi-muscle group combined stimulation, lack of graded potential output and timing coordinated control, and low efficiency of rehabilitation program reuse.

[0007] Technical solution

[0008] To achieve the above objectives, the present invention provides the following technical solution: a multi-channel potential graded output electrostimulation therapy device, comprising a host, a control unit, an electrostimulation generation module, and multiple output ports, characterized in that: each output port constitutes at least three independent and controllable electrostimulation channels, each stimulation channel can independently output electrostimulation signals of three different intensity levels: low potential, medium potential, and high potential; the multiple output ports include configurations of independent physical channels, single-channel multi-output, or a combination of both; the host is further provided with an electrostimulation output port assembly, used to combine the output ports with any other channel's medium or high potential through a common terminal to form a stimulation circuit; the low potential stimulation signal is a common reference terminal, which can be combined with any one or more medium or high potential output terminals to form a stimulation circuit; the number of stimulation channels is configured according to clinical needs and is not limited to a specific number of channels; each stimulation channel has a common reference terminal function, any channel can be used as a common reference terminal, and combined with any one or more other channels' medium or high potential outputs to form a stimulation circuit; the electrostimulation output port assembly includes a three-channel pulsed electrostimulation line, the electrostimulation output port assembly is mounted on the host, and the three-pin socket of the output port is located inside the port.

[0009] Preferably, the therapeutic device further includes: a timing programming module for independently programming and setting the stimulation start time, duration, and interval time of each stimulation channel; and a combination control module for controlling each stimulation channel to output electrical stimulation signals in a coordinated manner according to a preset rehabilitation treatment plan and a set timing relationship. The combination control module is configured such that each output terminal can achieve synchronous or sequential stimulation of multiple functional actions in a single treatment through different potential combinations of at least three stimulation channels.

[0010] Preferably, the therapeutic device further includes a combined stimulation mode, which is configured such that, during a single treatment, the output terminal achieves synchronous or sequential stimulation of at least two functional actions through the coordinated output of at least three stimulation channels. The stimulation timing of each stimulation channel is independently set by a timing programming module to achieve a coordinated movement mode of multiple functional actions. Among the multiple output terminals, any one output terminal can serve as a common reference terminal and be combined with any one or more other output terminals to form a stimulation circuit. The electrode pads of each stimulation channel adopt a modular and detachable design, and the application position of the electrode pads on the patient's body surface can be freely combined and adjusted according to treatment needs. Each stimulation channel is equipped with an independent signal indicator light, which is used to display the output status, potential level, and working mode of the corresponding channel in real time.

[0011] A multi-channel potential graded output electrical stimulation therapy device further includes the following steps:

[0012] Step 1: Program setting: Obtain the patient's rehabilitation treatment goals, determine the muscle groups to be stimulated and the corresponding rehabilitation movements, divide the current range corresponding to the three levels of stimulation potential, select the number of output ports of the therapy device, allocate at least three independent and controllable electrical stimulation channels to each output port, and determine the body surface electrode application positions matched to each electrical stimulation channel.

[0013] Step 2: Circuit Construction: Select any one of the electrical stimulation channels as the low-potential common reference terminal, and configure the remaining electrical stimulation channels as medium-potential or high-potential output terminals as needed; configure to form four types of stimulation circuits, namely a single-point stimulation circuit with a single low-potential channel paired with a single medium-potential or high-potential channel, a multi-point synchronous stimulation circuit with a single low-potential channel paired with multiple medium-potential or high-potential channels, an array-type stimulation circuit with multiple low-potential channels paired with multiple medium-potential or high-potential channels, and a polarity dynamic switching circuit that switches between low and high potentials in the same electrical stimulation channel at different times; complete the potential matching between the same-side channel, the opposite-side channel, and the cross-port channel to build a complete electrical stimulation circuit;

[0014] Step 3: Timing Programming: The timing programming module independently sets the stimulation start time, duration, interval, and number of cycles for each electrical stimulation channel; the combination control module binds the timing linkage logic of multiple electrical stimulation channels, setting three working modes: synchronous stimulation, time-sequential stimulation, and alternating cyclic stimulation. The coordinated stimulation timing schemes corresponding to any one or more combinations of movements such as foot dorsiflexion, hand grasping, wrist dorsiflexion, ankle plantarflexion, knee flexion and extension, and hip flexion and extension are pre-entered, and all timing schemes are stored.

[0015] Step 4: Stimulation Output: Start the main unit of the therapy device. The internal control unit drives the electrical stimulation generation module to operate. The boost circuit, digital-to-analog converter circuit, constant current source circuit, and channel selection circuit work synchronously, and each electrical stimulation channel is turned on in sequence according to the timing preset in Step 3.

[0016] Step 5: Real-time control: Each electrical stimulation channel is equipped with an independent indicator light to display the current channel potential level and on / off status in real time. The display module synchronously displays the real-time current, working sequence, and stimulation mode parameters of all channels. During treatment, the input module receives adjustment commands to change the potential level, stimulation duration, and intermittent period of any electrical stimulation channel online. It can freely switch between single-port multi-channel time-sharing output mode, multi-independent physical channel synchronous output mode, or a combination of the two output modes.

[0017] Step Six: Shutdown and Parameter Storage: After the preset total treatment time is reached, the control unit sequentially cuts off the output of all electrical stimulation channels and shuts down the electrical stimulation generation module; it automatically records and stores the channel potential configuration parameters, timing parameters, and rehabilitation action combination scheme used in this treatment into the storage module, which can be retrieved and reused later.

[0018] Preferably, in step one, the current range of the three-level stimulation potential is as follows: low potential reference current 0.5mA to 5mA, medium potential reference current 5mA to 15mA, and high potential reference current 15mA to 30mA.

[0019] Preferably, in step three, when the rehabilitation goal is to stimulate the foot dorsiflexion and hand grasping in combination, the control logic of the configured synergistic stimulation timing scheme is as follows: the first stimulation channel is set to output at a medium or high potential to stimulate the tibialis anterior muscle to induce ankle dorsiflexion; the second stimulation channel is set to output at a low or medium potential to stimulate the gastrocnemius and hamstring muscles to regulate lower limb muscle tone; and the third stimulation channel is set to output at a medium or high potential to stimulate the finger flexors to induce hand grasping. Cross-channel potential shift is achieved through a common reference terminal, and the output of the three channels is synchronously linked to match the timing of the human body's natural limb synergistic movement.

[0020] Preferably, the output port configuration includes three forms: independent physical multi-channel output, single-port multi-channel time-division output, and a combination of independent physical channels and single-port multi-channel output. Each of the three electrical stimulation channels in each port has independent parameter adjustment authority.

[0021] Preferably, in step four, the electrical stimulation generation module further includes a polarity switching circuit. The polarity switching circuit works synchronously with the channel selection circuit and works with the same channel polarity dynamic switching circuit in step two to complete the polarity switching of the electrode output.

[0022] Preferably, the surface electrodes adopt a plug-in detachable structure, allowing for free replacement of the application position according to rehabilitation needs; the storage module pre-stores multiple standard rehabilitation programs, while also supporting user-defined editing, modification, naming, and deletion of exclusive stimulation sequence programs.

[0023] Beneficial effects

[0024] Compared with the prior art, the present invention provides a multi-channel potential graded output electrical stimulation therapy device and its control method, which has the following beneficial effects:

[0025] 1. This multi-channel potential-graded output electrical stimulation therapy device and its control method are described. Each output port is configured with at least three independent and controllable electrical stimulation channels. Each channel employs three-wire pulse technology, and by setting a common terminal, left potential, and right potential, each channel can output two or more electrical pulse waveforms. The device allows for customizable port output modes, matching of zoned surface electrodes, and pre-storage of standardized rehabilitation timing schemes. It utilizes a low-potential common reference terminal to construct four types of stimulation circuits, enabling synchronous stimulation of multiple muscle groups. This prevents poor compatibility of stimulation schemes and discrepancies between stimulation timing and the natural movement patterns of the human body, significantly improving the accuracy of rehabilitation electrical stimulation. Simultaneously, it supports local storage and retrieval of schemes, effectively improving the efficiency of rehabilitation scheme reuse.

[0026] 2. This invention relates to a multi-channel potential-grade output electrostimulation therapy device and its control method. The invention utilizes an electrostimulation generation module with a constant current source, polarity switching circuit, and independent indicator lights for each channel to stably output a constant stimulation current in three levels: low, medium, and high. It also provides a synchronous and visual display of the potential and on / off status of each channel. During the treatment process, it supports online adjustment of various stimulation parameters without stopping the device, preventing current fluctuations from burning the patient's skin and ensuring that the working status of the channels is not difficult to judge intuitively. This significantly improves the safety and flexibility of parameter adjustment throughout the treatment process.

[0027] 3. The multi-channel potential graded output electrical stimulation therapy device and its control method utilize an automatic shutdown and archiving storage module. After the device reaches the preset treatment time, it automatically cuts off all stimulation outputs, completely retaining all treatment parameters such as channel potentials, stimulation sequences, and rehabilitation action combinations. During follow-up visits, the entire treatment plan can be retrieved and reused with one click, preventing the loss of parameters in a single treatment, the time-consuming manual repeated debugging, and the easy occurrence of parameter configuration errors, thereby improving the efficiency of rehabilitation treatment and the accuracy of parameter settings.

[0028] 4. This multi-channel potential-grade output electrical stimulation therapy device, through various output configuration methods, can flexibly adapt to the needs of different patients, different rehabilitation stages, and different equipment models. Whether it is a single channel with multiple outputs or multiple independent channel outputs, as long as combined functional electrical stimulation and multiple action combination stimulation are achieved, it is within the protection scope of this invention.

[0029] 5. This multi-channel potential-grade output electrical stimulation therapy device has a common reference terminal for each channel. Any channel can be used as a common terminal to form a stimulation circuit by combining with the medium or high potential of any other channel. The low, medium, and high potentials between left and right channels, and between upper and lower channels, can be arbitrarily combined, including ipsilateral combinations, contralateral combinations, and multi-channel combinations, to achieve flexible stimulation circuit configuration. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the overall structure of an electrostimulation therapy device with multi-channel potential graded output proposed in this invention;

[0031] Figure 2 This is a schematic diagram of the output port structure of an electrostimulation therapy device with multi-channel potential graded output proposed in this invention;

[0032] Figure 3 This is a schematic diagram of various modules of an electrostimulation therapy device and its control method with multi-channel potential graded output proposed in this invention;

[0033] Figure 4 This is a flowchart illustrating the operation steps of a multi-channel potential graded output electrostimulation therapy device and its control method proposed in this invention.

[0034] In the diagram: 1. Host; 2. Output port. Detailed Implementation

[0035] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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.

[0036] Please see Figure 1 - Figure 4 As shown, a multi-channel potential graded output electrical stimulation therapy device includes a host 1, a control unit, an electrical stimulation generation module and multiple output ports 2. Each output port 2 constitutes at least three independent and controllable electrical stimulation channels. Each stimulation channel can independently output electrical stimulation signals of three different intensity levels: low potential, medium potential and high potential. The multiple output ports 2 include configurations of independent physical channels, single-channel multiple output or a combination of both.

[0037] The current intensity of the low-potential stimulation signal is 0.5mA to 5mA;

[0038] The current intensity of the mid-potential stimulation signal is 5mA to 15mA;

[0039] The current intensity of the high-potential stimulation signal is 15mA to 30mA;

[0040] The output consists of three independent and controllable stimulation channels. Each channel is connected to a set of electrode pads via wires. Users set the stimulation parameters and modes for each channel through the input module, and the display module shows the working status of each channel in real time. Each stimulation channel is equipped with an independent signal indicator light to display the output status of the corresponding channel in real time.

[0041] Each stimulation channel can independently output electrical stimulation signals of three different intensities: low potential, medium potential, and high potential. Each stimulation channel uses three-wire pulse technology, and by setting a common terminal, left potential, and right potential, each channel can output more than two electrical pulse waveforms.

[0042] The host 1 is also provided with an electrical stimulation output port 2 component, which is used to form a stimulation circuit by combining the medium or high potential of any other channel through the common terminal of the output port 2.

[0043] The low-potential stimulation signal is a common reference terminal, which can be combined with any one or more medium-potential or high-potential output terminals to form a stimulation circuit.

[0044] The number of stimulation channels is configured according to clinical needs and is not limited to a specific number of channels;

[0045] Each stimulation channel has a common reference terminal function. Any channel can be used as a common reference terminal and combined with the medium or high potential output of any one or more other channels to form a stimulation circuit. The output terminal of the main channel is connected to a multiplexer switch. According to the control signal of the timing programming module, the multiplexer switch outputs the electrical stimulation signal sequentially or cyclically to different electrode groups according to the preset timing sequence.

[0046] The electrical stimulation output port 2 assembly includes a three-channel pulsed electrical stimulation wire. The electrical stimulation output port 2 assembly is installed on the host 1, and the three-pin socket of the output port 2 is located inside the port.

[0047] The treatment device also includes:

[0048] The timing programming module is used to independently program and set the stimulation start time, duration, and interval time for each stimulation channel;

[0049] The combined control module is used to control each stimulation channel to output electrical stimulation signals in a coordinated manner according to a preset timing relationship, based on a preset rehabilitation treatment plan.

[0050] The combined control module is configured such that each output terminal can achieve synchronous or sequential stimulation of multiple functional actions in a single treatment through different potential combinations of at least three stimulation channels.

[0051] The therapeutic device also includes a combined stimulation mode, which is configured to achieve synchronous or sequential stimulation of at least two functional movements through the coordinated output of at least three stimulation channels during a single treatment session. The stimulation timing of each stimulation channel is independently set by a timing programming module to achieve a coordinated movement mode of multiple functional movements. Any one of the multiple outputs can serve as a common reference, combining with any one or more other outputs to form a stimulation circuit. The electrode pads of each stimulation channel adopt a modular and detachable design, and the application position of the electrode pads on the patient's body surface can be freely combined and adjusted according to treatment needs. Each stimulation channel is equipped with an independent signal indicator light, which is used to display the output status, potential level, and operating mode of the corresponding channel in real time.

[0052] The electrostimulation therapy device also includes a display module, a storage module, an input module, and a function module. The electrostimulation generation module includes a boost circuit, an output circuit, a constant current source circuit, a channel selection circuit, a polarity switching circuit, and a pulse circuit.

[0053] A method for controlling electrical stimulation therapy with multi-channel potential graded output further includes the following steps:

[0054] Step 1: Obtain the patient's rehabilitation treatment goals, determine the muscle groups to be stimulated and the corresponding rehabilitation movements, divide the current range corresponding to the three-level stimulation potential, select the number of output ports 2 of the treatment device, allocate at least three independent and controllable electrical stimulation channels to each output port 2, and determine the body surface electrode application position matched to each electrical stimulation channel.

[0055] Step 2: Select any one of the electrical stimulation channels as the low-potential common reference terminal, and configure the remaining electrical stimulation channels as medium-potential or high-potential output terminals as needed; configure to form four types of stimulation circuits, namely a single-point stimulation circuit with a single low-potential channel paired with a single medium-potential or high-potential channel, a multi-point synchronous stimulation circuit with a single low-potential channel paired with multiple medium-potential or high-potential channels, an array-type stimulation circuit with multiple low-potential channels paired with multiple medium-potential or high-potential channels, and a polarity dynamic switching circuit that switches between low and high potentials in the same electrical stimulation channel in a time-sharing manner; complete the potential matching between the same-side channel, the opposite-side channel, and the cross-port channel to build a complete electrical stimulation circuit;

[0056] Step 3: Independently set the stimulation start time, duration, interval, and number of cycles for each electrical stimulation channel using the timing programming module; bind the timing linkage logic of multiple electrical stimulation channels using the combination control module, set three working modes: synchronous stimulation, time-sequential stimulation, and alternating cyclic stimulation; pre-enter the synergistic stimulation timing schemes corresponding to any one or more combinations of movements such as foot dorsiflexion, hand grasping, wrist dorsiflexion, ankle plantarflexion, knee flexion and extension, and hip flexion and extension, and store all timing schemes.

[0057] Step 4: Start the main unit 1 of the therapeutic instrument. The internal control unit of the main unit 1 drives the electrical stimulation generation module to run. The boost circuit, digital-to-analog conversion circuit, constant current source circuit and channel selection circuit work synchronously and conduct each electrical stimulation channel in sequence according to the timing preset in Step 3.

[0058] Step 5: Each electrical stimulation channel is equipped with an independent indicator light to display the current channel potential level and on / off status in real time. The display module synchronously displays the real-time current, working sequence, and stimulation mode parameters of all channels. During treatment, the input module receives adjustment commands to change the potential level, stimulation duration, and interval of any electrical stimulation channel online. It can freely switch between single-port multi-channel time-sharing output mode, multi-independent physical channel synchronous output mode, or a combination of the two output modes.

[0059] Step Six: After the preset total treatment time is reached, the control unit sequentially cuts off the output of all electrical stimulation channels and shuts down the electrical stimulation generation module; it automatically records and stores the channel potential configuration parameters, timing parameters, and rehabilitation action combination scheme used in this treatment to the storage module, supporting subsequent retrieval and reuse.

[0060] Furthermore, in step one, the specific current ranges for the three levels of stimulation potentials are: low potential reference current 0.5mA–5mA, medium potential reference current 5mA–15mA, and high potential reference current 15mA–30mA. By dividing the current ranges into gradient segments, three treatment needs—sensory relaxation, basic rehabilitation, and high-intensity resistance training—are differentiated. Low potentials are suitable for neurosensory arousal, medium potentials are suitable for conventional functional movement induction, and high potentials are suitable for muscle strengthening training. This allows for precise matching of stimulation intensity to different muscle tolerance levels, avoiding the limitation of a single current level being unable to adapt to the differentiated rehabilitation needs of multiple muscle groups, and improving the accuracy of electrical stimulation therapy and patient comfort.

[0061] Furthermore, in step three, when the rehabilitation goal is combined stimulation of foot dorsiflexion and hand grasping, the control logic of the configured synergistic stimulation timing scheme is as follows: the first stimulation channel is set to a medium or high potential output to stimulate the tibialis anterior muscle to induce ankle dorsiflexion; the second stimulation channel is set to a low or medium potential output to stimulate the gastrocnemius and hamstring muscles to regulate lower limb muscle tone; and the third stimulation channel is set to a medium or high potential output to stimulate the finger flexors to induce hand grasping. Cross-channel potential shifting is achieved through a common reference terminal, synchronously linking the outputs of the three channels to match the natural limb synergistic movement timing. This cross-channel linkage circuit, built upon the common reference terminal, synchronously regulates the differentiated potential outputs of the three muscle groups in the upper and lower limbs, replicating the physiological movement patterns of multi-muscle synergistic force exertion during human walking and grasping. This solves the problem that traditional equipment can only stimulate one side and one part individually and cannot simultaneously complete combined rehabilitation movements of the upper and lower limbs, enhancing the effect of neuromotor pathway remodeling and improving the effectiveness of combined movement rehabilitation training.

[0062] Furthermore, the output port 2 can be configured in three ways: independent physical multi-channel output, single-port multi-channel time-sharing output, and a combination of independent physical channel and single-port multi-channel output. Each of the three electrical stimulation channels in each port has independent parameter adjustment authority. The three output modes can be flexibly switched according to the number of beds and the complexity of rehabilitation movements. Independent physical channels are suitable for simultaneous treatment of multiple patients, single-port time-sharing output is suitable for single-person multi-muscle group time-sharing training, and the hybrid mode is suitable for complex multi-limb combined rehabilitation. Each channel can independently adjust the potential, duration, and interval parameters without interference, breaking away from the limitations of traditional equipment channel output modes and uniform parameter adjustment, and greatly expanding the clinical application scenarios of the equipment.

[0063] Furthermore, in step four, the electrical stimulation generation module also includes a polarity switching circuit. The polarity switching circuit works synchronously with the channel selection circuit, and works with the same channel polarity dynamic switching circuit in step two to complete the switching of electrode output polarity. The polarity switching circuit and the channel selection circuit work together to switch the positive and negative output polarities of the electrodes at regular intervals, change the direction of current in the muscle, prevent tolerance problems such as muscle adaptation, local tingling, and skin numbness caused by long-term unidirectional electrical stimulation, continuously maintain the sensitivity of neuromuscular to electrical signals, and enrich the types of stimulation circuits to adapt to more muscle tone regulation and sensory reconstruction rehabilitation scenarios.

[0064] Finally, the surface electrodes adopt a detachable, plug-in structure, allowing for easy repositioning based on rehabilitation needs. The storage module pre-stores multiple standard rehabilitation protocols and supports user-defined editing, modification, naming, and deletion of personalized stimulation sequence plans. Medical staff can quickly adjust electrode placement to suit different rehabilitation muscle groups such as the ankle, knee, and hand. The storage module also includes a built-in standardized rehabilitation sequence plan that can be retrieved with a single click, while offering custom editing permissions. This allows for the retention of personalized treatment parameters for each patient, avoiding repeated setting of timing and potential parameters for each treatment, reducing workload for medical staff, and ensuring consistent and stable rehabilitation treatment plans for each patient.

[0065] The working principle is as follows: Before formally conducting rehabilitation electrical stimulation therapy, the operator first selects the output port combination based on the patient's injury location and rehabilitation stage. Options include independent physical channels, single-port multi-channel time-sharing output, or a combination of both modes. Then, according to the preset rehabilitation movements, the detachable, plug-in-type surface electrodes are precisely applied to the skin corresponding to the target muscle groups such as the tibialis anterior, finger flexors, and gastrocnemius. All port assignments, potential ranges, electrode positions, and other parameters are simultaneously stored in the device's built-in storage module for easy retrieval later. Subsequently, the system sets any one of the electrical stimulation channels as a low-potential common reference terminal (0.5mA–5mA), autonomously constructing four types of stimulation circuits: single-point, multi-point synchronous, array-type, and polarity-dynamic switching. Relying on the common terminal, it completes cross-port potential translation, achieving synchronous potential linkage stimulation of multiple muscle groups such as foot dorsiflexion, hand grasping, and wrist dorsiflexion. Simultaneously, the timing programming module and the combination control module can be used to individually set the stimulation start time, duration, interval and number of cycles for each channel. Three linkage working modes are preset: synchronous stimulation, time-sequential stimulation and alternating cyclic stimulation. The device has multiple sets of standard timing schemes adapted to upper and lower limb rehabilitation stored in the device and kept for long-term backup to prevent poor adaptation of stimulation schemes and disconnection between muscle group stimulation timing and the body's natural coordinated movement, thereby improving the accuracy of rehabilitation stimulation and the efficiency of treatment scheme reuse.

[0066] After completing the initial parameter and timing settings, the main unit 1 of the therapeutic instrument is started. The main control display module of the whole machine issues the running command, which synchronously drives all the internal circuits of the electrical stimulation generation module to work together. The boost circuit increases the basic power supply voltage to the working voltage required for electrical stimulation. The digital-to-analog conversion circuit converts the digital timing signal into an analog pulse waveform adapted to human muscles. The constant current source circuit continuously and stably outputs low, medium and high grade current to avoid large fluctuations in current. The channel selection circuit strictly conducts the corresponding sub-channels in each output port 2 in sequence according to the preset timing. The polarity switching circuit synchronously switches the output polarity of the electrodes to match the working requirements of the polarity dynamic switching circuit. The formed electrical pulse is conducted to the body surface electrode through the output port 2 to perform functional stimulation on the target neuromuscular group. Throughout the treatment process, each electrical stimulation channel is equipped with an independent indicator light, which intuitively displays the current channel potential level and on / off status. The display screen synchronously refreshes the real-time current, operating sequence, stimulation mode and other core parameters of all channels in real time. Physicians can issue adjustment commands online through the device input module, modify the potential intensity, stimulation duration and interval of any channel without interrupting treatment, and freely switch between various port output modes. This prevents skin burns caused by output current fluctuations and ensures that the channel working status can be intuitively monitored, thereby improving the safety of the treatment process and the flexibility of real-time parameter adjustment.

[0067] When the device reaches the preset total treatment time, the built-in control unit will sequentially cut off the output of all electrical stimulation channels, simultaneously shutting down the boost and pulse output circuits of the electrical stimulation generation module, terminating all stimulation signal output. The device's storage module will automatically and completely archive all data from this treatment, including the potential configuration parameters of each channel, stimulation timing interval parameters, and the selected limb coordination rehabilitation action combination scheme. All records are stored locally for a long time. Patients can retrieve the entire scheme with one click for reuse during their next follow-up rehabilitation visit, eliminating the need for operators to repeatedly configure parameters. This prevents the loss of parameters during a single treatment and avoids the time wasted on repeated adjustments during each rehabilitation session. It also avoids potential and timing configuration errors when manually resetting parameters, improving the efficiency of rehabilitation scheme reuse and the accuracy of parameter settings.

[0068] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes the element.

Claims

1. A multi-channel potential graded output electrical stimulation therapy device, comprising a main unit (1), a control unit, an electrical stimulation generation module, and multiple output ports (2), characterized in that: Each of the output ports (2) constitutes at least three independent and controllable electrical stimulation channels. Each stimulation channel can independently output electrical stimulation signals of three different intensity levels: low potential, medium potential, and high potential. The multiple output ports (2) include configurations of independent physical channels, single-channel multiple output, or a combination of both. The host (1) is also provided with an electrical stimulation output port (2) component, which is used to form a stimulation circuit by combining the medium or high potential of any other channel through the common terminal of the output port (2); The low-potential stimulation signal is a common reference terminal, which can be combined with any one or more medium-potential or high-potential output terminals to form a stimulation circuit. The number of stimulation channels is configured according to clinical needs and is not limited to a specific number of channels; Each stimulation channel has a common reference terminal function. Any channel can be used as a common reference terminal and combined with the medium or high potential output of any one or more other channels to form a stimulation circuit. The electrical stimulation output port (2) assembly includes a three-channel pulse electrical stimulation line. The electrical stimulation output port (2) assembly is installed on the host (1). The three-pin socket of the output port (2) is located inside the port.

2. The multi-channel potential graded output electrical stimulation therapy device according to claim 1, characterized in that: The therapeutic device also includes: The timing programming module is used to independently program and set the stimulation start time, duration, and interval time for each stimulation channel; The combined control module is used to control each stimulation channel to output electrical stimulation signals in a coordinated manner according to a preset timing relationship, based on a preset rehabilitation treatment plan. The combined control module is configured such that each output terminal can achieve synchronous or sequential stimulation of multiple functional actions in a single treatment through different potential combinations of at least three stimulation channels.

3. The multi-channel potential graded output electrical stimulation therapy device according to claim 2, characterized in that: The therapeutic device also includes a combined stimulation mode, which is configured to achieve synchronous or sequential stimulation of at least two functional actions through the coordinated output of at least three stimulation channels during a single treatment. The stimulation timing of each stimulation channel is independently set by the timing programming module to achieve a coordinated movement mode of multiple functional actions. Among the multiple outputs, any one output can be used as a common reference end and combined with any one or more other outputs to form a stimulation circuit. The electrode pads of each stimulation channel adopt a modular and detachable design. The application position of the electrode pads on the patient's body surface can be freely combined and adjusted according to treatment needs. Each stimulation channel is equipped with an independent signal indicator light, which is used to display the output status, potential level and working mode of the corresponding channel in real time.

4. The multi-channel potential graded output electrical stimulation therapy device according to claim 3, characterized in that: The electrostimulation therapy device also includes a display module, a storage module, an input module, and a function module. The electrostimulation generation module includes a boost circuit, an output circuit, a constant current source circuit, a channel selection circuit, a polarity switching circuit, and a pulse circuit.

5. A control method for a multi-channel potential graded output electrical stimulation therapy device, applied to the multi-channel potential graded output electrical stimulation therapy device according to any one of claims 1-4, characterized in that: It also includes the following steps: Step 1: Program setting: Obtain the patient's rehabilitation treatment goals, determine the muscle groups to be stimulated and the corresponding rehabilitation movements, divide the current range corresponding to the three-level stimulation potential, select the number of output ports (2) of the therapy device, allocate at least three independent and controllable electrical stimulation channels to each output port (2), and determine the body surface electrode application position matched for each electrical stimulation channel. Step 2: Circuit Construction: Select any one of the electrical stimulation channels as the low-potential common reference terminal, and configure the remaining electrical stimulation channels as medium-potential or high-potential output terminals as needed; configure to form four types of stimulation circuits, namely a single-point stimulation circuit with a single low-potential channel paired with a single medium-potential or high-potential channel, a multi-point synchronous stimulation circuit with a single low-potential channel paired with multiple medium-potential or high-potential channels, an array-type stimulation circuit with multiple low-potential channels paired with multiple medium-potential or high-potential channels, and a polarity dynamic switching circuit that switches between low and high potentials in the same electrical stimulation channel at different times; complete the potential matching between the same-side channel, the opposite-side channel, and the cross-port channel to build a complete electrical stimulation circuit; Step 3: Timing Programming: The timing programming module independently sets the stimulation start time, duration, interval, and number of cycles for each electrical stimulation channel; the combination control module binds the timing linkage logic of multiple electrical stimulation channels, setting three working modes: synchronous stimulation, time-sequential stimulation, and alternating cyclic stimulation. The coordinated stimulation timing schemes corresponding to any one or more combinations of movements such as foot dorsiflexion, hand grasping, wrist dorsiflexion, ankle plantarflexion, knee flexion and extension, and hip flexion and extension are pre-entered, and all timing schemes are stored. Step 4: Stimulation output: Start the main unit (1) of the therapeutic instrument. The internal control unit of the main unit (1) drives the electrical stimulation generation module to run. The boost circuit, digital-to-analog conversion circuit, constant current source circuit and channel selection circuit work synchronously and conduct each electrical stimulation channel in sequence according to the time sequence preset in Step 3. Step 5: Real-time control: Each electrical stimulation channel is equipped with an independent indicator light to display the current channel potential level and on / off status in real time. The display module synchronously displays the real-time current, working sequence, and stimulation mode parameters of all channels. During treatment, the input module receives adjustment commands to change the potential level, stimulation duration, and intermittent period of any electrical stimulation channel online. It can freely switch between single-port multi-channel time-sharing output mode, multi-independent physical channel synchronous output mode, or a combination of the two output modes. Step Six: Shutdown and Parameter Storage: After the preset total treatment time is reached, the control unit sequentially cuts off the output of all electrical stimulation channels and shuts down the electrical stimulation generation module; it automatically records and stores the channel potential configuration parameters, timing parameters, and rehabilitation action combination scheme used in this treatment into the storage module, which can be retrieved and reused later.

6. The control method for a multi-channel potential graded output electrical stimulation therapy device according to claim 5, characterized in that: In step one, the specific current ranges for the three levels of stimulation potentials are as follows: low potential reference current 0.5mA~5mA, medium potential reference current 5mA~15mA, and high potential reference current 15mA~30mA.

7. The control method for a multi-channel potential graded output electrical stimulation therapy device according to claim 5, characterized in that: In step three, when the rehabilitation goal is to stimulate the foot dorsiflexion and hand grasping in combination, the control logic of the configured synergistic stimulation timing scheme is as follows: the first stimulation channel is set to output at a medium or high potential to stimulate the tibialis anterior muscle to induce ankle dorsiflexion; the second stimulation channel is set to output at a low or medium potential to stimulate the gastrocnemius and hamstring muscles to regulate lower limb muscle tone; and the third stimulation channel is set to output at a medium or high potential to stimulate the finger flexors to induce hand grasping. Cross-channel potential shift is achieved through a common reference terminal, and the output of the three channels is synchronized to match the timing of the body's natural limb synergistic movement.

8. The control method for a multi-channel potential graded output electrical stimulation therapy device according to claim 5, characterized in that: The output port (2) can be configured in three ways: independent physical multi-channel output, single-port multi-channel time-division output, and combination of independent physical channel and single-port multi-channel output. Each of the three electrical stimulation channels in each port has independent parameter control authority.

9. The control method for a multi-channel potential graded output electrical stimulation therapy device according to claim 5, characterized in that: In step four, the electrical stimulation generation module also includes a polarity switching circuit. The polarity switching circuit works synchronously with the channel selection circuit and works with the same channel polarity dynamic switching circuit in step two to complete the polarity switching of the electrode output.

10. The control method for a multi-channel potential graded output electrical stimulation therapy device according to claim 5, characterized in that: The surface electrodes adopt a plug-in detachable structure, allowing for free replacement of the application position according to rehabilitation needs; the storage module pre-stores multiple standard rehabilitation programs, while also supporting user-defined editing, modification, naming, and deletion of exclusive stimulation sequence programs.

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