A flexible wearable knee and calf electrical stimulation device and a control method thereof

Abstract

The present application relates to a kind of flexible wearable knee and lower leg electric stimulation device and its control method, it is related to human body rehabilitation auxiliary equipment technical field.The device includes flexible fixing assembly, multiple electrode assembly and control handle, control handle is integrated with control module, electrode drive module and reconfigurable connection structure.The present application realizes stable fit with the complex surface of knee and lower leg by flexible fixing assembly, realizes whole coverage of stimulation area by multiple electrode distributed layout, realizes hardware level dynamic reconfiguration of stimulation path by reconfigurable connection structure.The control method includes: based on IFC or TIS waveform generates double-channel or multi-channel stimulation signal;By electrode combination optimization algorithm dynamically selects optimal electrode pair;And based on the adaptive parameter adjustment of bioelectric feedback.The present application realizes the multidimensional flexible control of stimulation area, stimulation path and stimulation parameter, significantly improves rehabilitation effect and use experience.

Description

Technical Field

[0001] This invention relates to the field of human electrical stimulation and rehabilitation assistive devices, specifically to a flexible wearable electrical stimulation device for the knee joint and calf and its control method. Background Technology

[0002] Electrical stimulation technology is an effective means of rehabilitation for the knee and lower leg, but the electrode layout, stimulation path and wearing method of existing devices are difficult to adapt to the complex structure and functional needs of this area.

[0003] A search revealed that Chinese invention patent CN120882450A discloses a universal electrostimulation device. This patent focuses on an electrode design where the electrodes utilize moisture (such as sweat) generated by the user's body to reduce contact resistance between the electrodes and the skin, eliminating the need for applying conductive gel before use, simplifying the preparation process and improving wearing comfort. Its key feature is improving electrode materials to utilize skin moisture to reduce contact resistance, thereby enhancing ease of use. However, this solution does not break through the traditional point-to-point or small-pair electrode stimulation mode; the electrode layout is fixed, making it difficult to achieve comprehensive coverage and flexible combination of multiple muscle groups around the knee. Chinese invention patent CN121338236A discloses a non-invasive electrostimulation device for stellate ganglion block. The core of this patent lies in achieving closed-loop feedback and adaptive adjustment of stimulation parameters by collecting physiological parameters such as heart rate and body temperature, demonstrating a high level of intelligence. However, its core technology lies in the adaptive parameters at the software level; the system is complex and requires precise positioning, mainly suitable for deep, fixed-point stimulation, and cannot solve the problems of multi-electrode distributed networking and hardware reconstruction for large-area muscle groups.

[0004] Chinese invention patent CN121041588A discloses an elastic-binding abdominal muscle electrical stimulation device, which uses a strap and multiple independent mechanical clamping devices to ensure that the electrode pads remain in close contact with the skin during abdominal movement, effectively solving the problem of wearing stability in flat or single-curved areas. This design is primarily aimed at flat areas such as the abdomen, but its rigid clamping method is difficult to adapt to the complex curvature and large movements of the knee joint, potentially leading to localized pressure discomfort. Furthermore, it does not address the programmability of the stimulation path.

[0005] In summary, existing technical solutions focus on contact optimization, intelligent control, or mechanical fixation, but all have shortcomings: fixed electrode layout and connections result in limited stimulation areas and single pathways; the wearable structure has poor adaptability to the dynamic curvature of the knee and lower leg, affecting stability and comfort. Therefore, there is an urgent need for a dedicated electrical stimulation device for the knee and lower leg that can achieve a distributed multi-electrode layout and hardware-level dynamic reconstruction of stimulation pathways based on flexible fit. Summary of the Invention

[0006] To address the shortcomings of existing technologies, the technical problem to be solved by this invention is to provide a flexible wearable electrical stimulation device for the knee and calf joints and its control method, so as to solve the problems of limited stimulation area coverage, fixed and single stimulation path, and unstable contact caused by easy displacement during wearing in existing technologies, and further realize the diversification of stimulation modes and intelligent control.

[0007] The first objective of this invention is to provide a flexible wearable electrical stimulation device for the knee and calf joints, comprising a flexible fixation component, a multi-electrode component, and a control handle; the flexible fixation component covers the knee and calf regions of the human body; the multi-electrode component includes multiple circular electrodes installed inside the flexible fixation component and distributed along the knee and calf regions; the control handle is electrically connected to the multiple circular electrodes via connecting wires, and the control handle can switch the electrical connection paths between the circular electrodes.

[0008] In some possible implementations, the control handle includes a control module, an electrode drive module, and a reconfigurable connection structure; the input of the electrode drive module is connected to the control module, the output of the electrode drive module is connected to the input of the reconfigurable connection structure, and the output of the reconfigurable connection structure is electrically connected to a plurality of the circular electrodes via the connecting line; the reconfigurable connection structure is controlled by the control module and is used to switch the electrical connection paths between the circular electrodes.

[0009] In some possible implementations, the control handle further includes a wireless communication module, a battery management module, and a bioelectric signal acquisition module; the wireless communication module is electrically connected to the control module; the battery management module is provided with a USB interface for charging; the input terminal of the bioelectric signal acquisition module is connected to at least one of the circular electrodes via the connecting line, and the signal output terminal of the bioelectric signal acquisition module is connected to the control module.

[0010] In some possible implementations, the reconfigurable connection structure is a switch matrix or a multiplexer circuit.

[0011] In some possible implementations, the flexible fixing component is provided with straps that securely fasten it to the user's leg, and the length of the straps is adjustable.

[0012] A second objective of this invention is to provide a control method for a flexible wearable electrical stimulation device for the knee and calf joints, applicable to the aforementioned flexible wearable electrical stimulation device for the knee and calf joints, comprising the following steps:

[0013] S1: The control module determines the target stimulation area and the corresponding target circular electrode combination according to the preset or externally input stimulation scheme;

[0014] S2: The control module sends a channel switching command to the reconfigurable connection structure to connect the stimulation output path of the electrode drive module to the target circular electrode assembly.

[0015] S3: The control module controls the electrode drive module to generate an electrical stimulation signal with a preset waveform, frequency, pulse width and intensity. The electrical stimulation signal is routed through a reconfigurable connection structure and then transmitted to the target circular electrode assembly through a connection line, and finally applied to the human body.

[0016] S4: During stimulation, the control module dynamically changes the target circular electrode combination and / or stimulation parameters according to the preset timing sequence or external instructions, thereby reconstructing the stimulation path and / or stimulation mode.

[0017] In some possible implementations, the target circular electrode combination in step S1 is determined by an electrode combination optimization algorithm, including: the control module evaluates the coupling efficiency between each electrode position and the target muscle group based on the electromyographic signals fed back by the bioelectric signal acquisition module or based on a preset anatomical mapping relationship, and preferentially selects the circular electrode pair with the highest coupling efficiency as the target electrode combination.

[0018] In some possible implementations, the electrical stimulation signal in step S3 is an interference waveform, which is generated by a method comprising: a control module controlling an electrode drive module to generate two or more carrier signals with different frequencies; outputting the carrier signals of different frequencies to circular electrode pairs at different spatial positions through a reconfigurable connection structure, so that the two signals intersect and interfere within human tissue, producing a low-frequency modulation effect; the frequency difference of the carrier signals is adjustable between 1Hz and 200Hz, and the stimulation depth is controlled by adjusting the frequency difference;

[0019] The electrical stimulation signal mentioned in step S3 is a high-frequency TIS waveform with a frequency range of 1000Hz to 10000Hz and a pulse width of 50μs to 500μs. High-frequency stimulation reduces skin impedance and achieves deep tissue penetration.

[0020] In some possible implementations, step S5 is also included: the bioelectric signal acquisition module acquires electromyographic signals of the target muscle group during the stimulation interval, and the control module evaluates the muscle response based on the amplitude and frequency characteristics of the electromyographic signals, and dynamically adjusts the stimulation intensity, frequency or pulse width in step S3 accordingly to achieve closed-loop feedback control; the dynamic adjustment includes: increasing the stimulation intensity when the electromyographic signal amplitude is lower than a preset threshold; and reducing the stimulation intensity or pausing stimulation when the electromyographic signal amplitude exceeds a safety threshold.

[0021] In some possible implementations, step S6 is also included: the control module uploads the stimulation process data to an external terminal via the wireless communication module and receives stimulation scheme update instructions from the external terminal.

[0022] The beneficial effects of this invention are:

[0023] 1. Hardware level: Stable fit with the complex curvature of the knee and lower leg is achieved through flexible fixation components, full coverage of the stimulation area is achieved through multi-electrode distributed layout, and hardware-level dynamic reconstruction of the stimulation path is achieved through reconfigurable connection structure.

[0024] 2. Methodological aspects: By introducing IFC waveforms, the interference effect of two signals of different frequencies in the body is utilized to achieve effective stimulation of deep tissues; by introducing high-frequency TIS waveforms, skin impedance is reduced, and stimulation comfort and penetration depth are improved.

[0025] 3. Intelligent control level: Through electrode combination optimization algorithm and closed-loop feedback control, the stimulation parameters are adaptively adjusted, which improves the accuracy and consistency of treatment effect. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the overall wearing structure of the device described in this invention;

[0027] Figure 2 This is a block diagram showing the internal module connection of the control handle of the present invention;

[0028] Figure 3 This is a circuit topology diagram of a specific embodiment of the reconfigurable connection structure in this invention.

[0029] The attached diagram lists the components represented by each number as follows:

[0030] 1-Flexible fixing component, E1~E12-Circular electrode, 2-Connecting wire, 3-Control handle, 31-Control module, 32-Electrode driving module, 33-Reconfigurable connection structure, 34-Wireless communication module, 35-Battery management module, 351-USB interface, 36-Bioelectric signal acquisition module, 331~334-Analog switch unit. Detailed Implementation

[0031] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0032] See Figure 1As shown, a flexible wearable electrical stimulation device for the knee and calf joints is disclosed. The device mainly comprises a flexible fixation component 1, a control handle 3 connected to it via a connecting cable 2, and a multi-electrode assembly as the core stimulation unit. The flexible fixation component 1 is a sleeve-shaped or unfoldable strip-shaped substrate that roughly conforms to the physiological curvature of the human knee joint and calf. It is made of a flexible material with good elasticity, biocompatibility, and breathability, such as an elastic fabric blended with spandex and nylon, medical silicone, or thermoplastic polyurethane (TPU) film, to ensure a good fit and comfort during wear. A fixing structure is provided on the flexible fixation component 1, which consists of at least one adjustable-length strap. This strap can be fixed by Velcro, buckles, or snaps, thereby securely binding the entire device to the user's leg and preventing displacement during activity.

[0033] The multi-electrode assembly consists of multiple independent circular electrodes E1, E2, ..., E12. These circular electrodes are arranged on the inner side (i.e., the side closest to the skin) of the flexible fixation component 1 in a preset two-dimensional array or functionally partitioned according to the anatomical location of the target muscle group (such as the quadriceps, hamstrings, gastrocnemius, etc.). Each circular electrode E1~E12 can be fixed to the corresponding position of the flexible fixation component 1 by means of conductive adhesive, heat-pressing into fabric, or mounting on a detachable flexible base (not shown separately in the figure). This distributed layout aims to cover the major muscle and nerve stimulation points around the knee joint and the lower leg.

[0034] The control handle 3 is electrically connected to the plurality of circular electrodes E1~E12 via the connecting cable 2, and the control handle 3 can switch the electrical connection path between each circular electrode E1~E12. (Continue to the previous section) Figure 1 The connecting line 2 is a flexible cable integrating multiple independent wires. One end of it converges at the side or bottom of the flexible fixing component 1 and is electrically connected to each of the circular electrodes E1~E12, while the other end is connected to the control handle 3, which is responsible for bidirectional transmission of electrical stimulation signals and bioelectric signals between the two.

[0035] See Figure 2 As shown, the control handle 3 is a portable housing that integrates the core control and drive circuitry of the device. Specifically, it includes:

[0036] Control module 31: As the control core of the system, it can be implemented using a microcontroller (MCU), microprocessor, or programmable logic device (such as STM32 series, PY32 series, etc.) commonly used in the field. Through its internally running control program, it is responsible for receiving instructions from the human-machine interface or wireless communication module 34, sending stimulation parameters (such as amplitude, frequency, and pulse width) to the electrode driving module 32, and dynamically configuring the stimulation path by sending control signals to the reconfigurable connection structure 33. Its electrical connection relationships with the various functional modules within the device are as follows: Figure 2 As shown.

[0037] Battery management module 35: Provides a stable power supply for the entire device. It includes a rechargeable battery (such as a lithium polymer battery) and corresponding power management circuitry. This circuitry can be implemented using common charging management ICs (such as TI's BQ series, ETA series, etc.), and is responsible for battery charging, discharging protection, and voltage conversion. The module has a USB interface 351 for charging.

[0038] Electrode driving module 32: Used to generate safe and controllable electrical stimulation pulses. It can be implemented using mature constant current or constant voltage electrical stimulation driving circuits, such as typical circuits based on H-bridges or dedicated electrical stimulation driving chips (such as Warmcore's NNC6121 series, TIDRV260X series, etc.). The input of this module receives parameter commands from the control module 31, and its output is connected to the reconfigurable connection structure 33, ultimately outputting the stimulation current to the selected electrode.

[0039] Reconfigurable connection structure 33: This is the key construction for achieving flexible stimulus pathways in this invention. For example... Figure 3As shown, a specific hardware configuration of the reconfigurable connection structure 33 consists of multiple analog switch units 331-334 connected in parallel. Taking four "one-input, multiple-output" analog switch units as an example, the input terminal of each analog switch unit is independently connected to a stimulation signal output channel of the electrode driving module 32. The multiple output terminals of each switch unit are connected to different circular electrodes E1-E12 via corresponding wires in the connection line 2. As a clear connection example: the three output terminals of analog switch unit 331 are connected to electrodes E1, E2, and E3 respectively; the three output terminals of analog switch unit 332 are connected to electrodes E7, E8, and E9 respectively (and so on for the remaining switch units, ensuring that all electrodes E1-E12 are covered). Each electrode has one and only one electrical path connected to the output terminal of a specific analog switch unit. The channel switching control terminals of all analog switch units 331-334 are connected to the control module 31 and are uniformly programmed and controlled by it. During operation, the control module 31 sends switching commands to each analog switch unit according to a preset stimulation scheme. For example, the instruction can be set to turn on the output terminal of switch unit 331 connected to electrode E2, and simultaneously turn on another switch unit (e.g., the unit connected to electrode E11) to its corresponding output terminal. At this time, the stimulation current of the corresponding channel of electrode drive module 32 will flow through the switch unit and connecting line 2 to electrode E2 as the current outflow point. After flowing through human tissue, the current is collected by electrode E11 and flows back to electrode drive module 32 through the corresponding switch unit and connecting line 2, thus establishing an effective stimulation circuit between electrodes E2 and E11. By changing the instructions to each switch unit in real time through control module 31, it is possible to quickly switch between different output channels, thereby flexibly combining multiple stimulation electrode pairs. This hardware structure based on a distributed analog switch array enables rapid selection and path reconstruction of any two electrodes (as long as they are connected to different switch units), providing a key hardware foundation for diversified and programmable stimulation of complex muscle groups in the knee and lower leg.

[0040] Bioelectric signal acquisition module 36: Used to acquire physiological signals for feedback control. It can be implemented using a general bioelectric signal preamplifier, filter, and analog-to-digital converter circuit (refer to conventional bioelectric signal acquisition designs, such as using an instrumentation amplifier, filter, and ADC, or Chinese patent CN105559780A, etc.). Its signal input terminal can be selectively connected to one or more circular electrodes E1~E12 via connecting line 2 (multiplexing these electrodes as sensors), and its signal output terminal transmits the processed digital signal to the control module 31 for analysis.

[0041] Wireless communication module 34: can adopt a standardized Bluetooth Low Energy (BLE) module (such as Nordic nRF52 / nRF54 series, Dialog DA145XX series, Telink TLSR series, etc.), which connects to the control module 31 through common interfaces such as UART and SPI to realize wireless transmission of commands and data.

[0042] The present invention also provides a control method for a flexible wearable knee and calf electrical stimulation device, which is applied to the above-mentioned flexible wearable knee and calf electrical stimulation device. The following detailed description is provided in conjunction with specific embodiments.

[0043] Example 1: Deep muscle stimulation based on interfering electrical current (IFC) waveforms

[0044] This embodiment provides a control method for stimulating deep muscle groups around the knee joint using IFC waveforms.

[0045] See Figure 2 and Figure 3 The user selects "IFC Deep Stimulation Mode" via the button on the control handle 3 or an external terminal APP. After receiving the instruction, the control module 31 executes the following steps:

[0046] S1: Determination of target electrode combination

[0047] The control module 31 determines the optimal electrode pair corresponding to the target muscle group (such as the deep quadriceps femoris) to be stimulated according to the preset anatomical mapping relationship. In this embodiment, electrode E2 under analog switch unit 331 and electrode E8 under analog switch unit 332 are selected as the electrode pair of the first stimulation channel; electrode E4 under analog switch unit 333 and electrode E10 under analog switch unit 334 are selected as the electrode pair of the second stimulation channel.

[0048] S2: Stimulus pathway remodeling

[0049] Control module 31 sends control commands to reconfigurable connection structure 33:

[0050] Instruction 1: Switch the input terminal of analog switch unit 331 to the output terminal of its connected electrode E2;

[0051] Instruction 2: Switch the input terminal of analog switch unit 332 to the output terminal of its connected electrode E8;

[0052] Instruction 3: Switch the input terminal of analog switch unit 333 to the output terminal of its connected electrode E4;

[0053] Instruction 4: Switch the input terminal of analog switch unit 334 to the output terminal of its connected electrode E10.

[0054] At this time, the two output channels of the electrode drive module 32 are electrically connected to the electrode pairs E2, E8 and E4, E10, respectively.

[0055] S3: IFC Stimulation Signal Generation and Output

[0056] Control module 31 controls electrode drive module 32 to generate two carrier signals of different frequencies:

[0057] Channel 1: Frequency 4000Hz, pulse width 100μs, amplitude 30mA;

[0058] Second channel: Frequency 4010Hz, pulse width 100μs, amplitude 30mA.

[0059] The frequency difference between the two signals is 10Hz. These two signals are output to the corresponding electrode pairs E2, E8 and E4, E10 through analog switch units 331~332 and 333~334, respectively. When the two signals converge in the deep tissues of the human knee joint, an interference modulation effect with a frequency of 10Hz is generated, which effectively stimulates the deep muscle groups.

[0060] S4: Dynamic parameter adjustment

[0061] During stimulation, the control module 31 can dynamically adjust the frequency difference between the two signals (e.g., from 10Hz to 50Hz) according to a preset program or user instructions, thereby changing the frequency of the interference effect and realizing layered stimulation of muscle groups from deep to superficial layers.

[0062] Example 2: Analgesic Stimulation Based on High-Frequency TIS Waveform

[0063] This embodiment provides a method for controlling analgesic stimulation of tissues around the knee joint using high-frequency TIS waveforms.

[0064] The user selects "TIS analgesia mode". Control module 31 performs the following steps:

[0065] S1: Determination of target electrode combination

[0066] The control module 31 determines the electrode combination corresponding to the pain area that needs to be stimulated. Based on... Figure 3 The hardware connection relationships shown are as follows (simulation switch unit 331 is connected to electrodes E1, E2, and E3; simulation switch unit 332 is connected to electrodes E7, E8, and E9; simulation switch units 333 and 334 are connected to the remaining electrodes). In this embodiment, two stimulation channels that operate simultaneously are selected:

[0067] First stimulation channel: Electrode pair consisting of electrode E1 under analog switch unit 331 and electrode E9 under analog switch unit 332;

[0068] The second stimulation channel is formed by electrode E3 under analog switch unit 331 and electrode E7 under analog switch unit 332.

[0069] The two electrode pairs are spatially crisscrossed, and their current pathways intersect and interfere in the target pain area, enhancing the analgesic effect.

[0070] S2: Stimulus pathway remodeling

[0071] Control module 31 sends control commands to reconfigurable connection structure 33, simultaneously establishing two independent stimulation pathways:

[0072] First path: Control analog switch unit 331 to switch the input terminal to the output terminal of its connected electrode E1; control analog switch unit 334 to switch the input terminal to the output terminal of its connected electrode E12.

[0073] Second path: Control analog switch unit 333 to switch the input terminal to the output terminal of its connected electrode E6; control analog switch unit 332 to switch the input terminal to the output terminal of its connected electrode E7.

[0074] Since each analog switch unit can only select one output terminal at a time, in order to enable the two channels to work simultaneously, this embodiment uses different pairs of analog switch units to carry the two stimulation channels: the first channel uses switch units 331 and 332, and the second channel uses switch units 333 and 334. The electrode driving module 32 needs to have two independent stimulation output channels, which are respectively connected to the two sets of switch units.

[0075] S3: High-frequency TIS stimulation signal generation and simultaneous output

[0076] The control module 31 controls the two independent output channels of the control electrode drive module 32 to simultaneously generate high-frequency pulse train stimulation signals with the same parameters, as set as follows:

[0077] Waveform type: High-frequency biphasic square wave;

[0078] Frequency: 5000Hz;

[0079] Pulse width: 150μs;

[0080] Amplitude: 20mA (adjustable according to patient tolerance, range 5mA~50mA);

[0081] Stimulation mode: continuous output or intermittent output (e.g., stimulation for 5 seconds, followed by a 5-second interval).

[0082] The two signals are output simultaneously through two sets of analog switching units:

[0083] The first signal is transmitted to electrodes E1 and E12 via analog switch units 331 and 334.

[0084] The second signal is transmitted to electrodes E6 and E7 via analog switch units 333 and 332.

[0085] Two high-frequency stimulation currents are simultaneously conducted within the tissues surrounding the knee joint, creating an interference electric field in the target pain area. This dual-channel simultaneous stimulation can produce the following synergistic effects:

[0086] Expanded coverage: The two electrode pairs are distributed in a cross pattern, allowing the stimulation electric field to cover a wider area;

[0087] Enhanced analgesic effect: Increased current density in the interference region more effectively activates the coarse fiber afferent pathway, producing a gate control effect;

[0088] Reduce adaptation: Alternating / simultaneous stimulation of multiple sites can reduce neural adaptation and maintain analgesic effect.

[0089] S4: Dynamic parameter adjustment (optional)

[0090] During stimulation, the control module 31 can dynamically adjust the stimulation parameters based on the electromyographic signals fed back by the bioelectric signal acquisition module 36 or manual adjustment by the user.

[0091] Frequency adjustment: adjustable within the range of 1000Hz to 10000Hz to meet different analgesic needs;

[0092] Amplitude adjustment: The two signals can be adjusted independently to achieve asymmetric stimulation;

[0093] Adjustable electrode combination: The electrode pairs involved in stimulation can be dynamically switched according to patient feedback to optimize the interference area.

[0094] Example 3: Adaptive Closed-Loop Control Based on Electromyographic Feedback

[0095] This embodiment provides a control method for adaptive closed-loop regulation using a bioelectric signal acquisition module 36.

[0096] During stimulation, the bioelectric signal acquisition module 36 acquires the electromyographic (EMG) signals of the target muscle group in real time by reusing some circular electrodes (such as E5 and E7).

[0097] Control module 31 performs real-time analysis of the acquired electromyographic signals, including:

[0098] Calculate the root mean square (RMS) value of the electromyographic signal to assess the degree of muscle activation;

[0099] Calculate the power spectrum of electromyographic signals to assess muscle fatigue status.

[0100] When the electromyographic amplitude is detected to be lower than the preset target threshold (indicating insufficient muscle response), the control module 31 automatically increases the output amplitude of the electrode drive module 32 (e.g., by 1mA each time, with an upper limit of 50mA).

[0101] When a shift in the electromyographic power spectrum to a lower frequency is detected (indicating muscle fatigue), the control module 31 automatically reduces the stimulation frequency or pauses stimulation, entering the recovery period.

[0102] Meanwhile, the control module 31 uploads real-time electromyographic data and stimulation parameters to an external terminal via the wireless communication module 34, generates a treatment report, and can remotely update the stimulation plan according to the doctor's advice.

[0103] Example 4: Dynamic scanning stimulation with electrode combination

[0104] This embodiment provides a stimulation method that achieves large-area coverage by dynamically switching electrode combinations.

[0105] The control module (31) periodically switches the activated electrode pairs during stimulation according to a preset timing sequence, creating a "scanning" effect. For example:

[0106] 0-5 seconds: Activate electrode pair (E1, E7);

[0107] 5-10 seconds: Activate electrode pair (E2, E8);

[0108] 10-15 seconds: Activate electrode pair (E3, E9);

[0109] 15-20 seconds: Activate electrode pair (E4, E10);

[0110] 20-25 seconds: Activate electrode pair (E5, E11);

[0111] 25-30 seconds: Activate electrode pair (E6, E12);

[0112] Repeating the cycle.

[0113] This dynamic scanning method provides full-coverage stimulation to the knee joint and calf area, making it suitable for large-area muscle relaxation or overall functional improvement.

[0114] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A flexible wearable electrical stimulation device for the knee joint and calf, characterized in that, The device includes a flexible fixation component (1), a multi-electrode component, and a control handle (3). The flexible fixation component (1) covers the knee joint and lower leg of the human body. The multi-electrode component includes multiple circular electrodes (E1~E12) installed inside the flexible fixation component (1) and distributed along the knee joint and lower leg area. The control handle (3) is electrically connected to the multiple circular electrodes (E1~E12) through a connecting line (2), and the control handle (3) can switch the electrical connection path between each circular electrode (E1~E12).

2. The flexible wearable knee and calf electrical stimulation device according to claim 1, characterized in that, The control handle (3) includes a control module (31), an electrode drive module (32), and a reconfigurable connection structure (33); the input end of the electrode drive module (32) is connected to the control module (31), the output end of the electrode drive module (32) is connected to the input end of the reconfigurable connection structure (33), and the output end of the reconfigurable connection structure (33) is electrically connected to multiple circular electrodes (E1~E12) through the connection line (2); the reconfigurable connection structure (33) is controlled by the control module (31) and is used to switch the electrical connection path between each circular electrode (E1~E12).

3. The flexible wearable electrical stimulation device for the knee joint and calf according to claim 1, characterized in that, The control handle (3) also includes a wireless communication module (34), a battery management module (35), and a bioelectric signal acquisition module (36); the wireless communication module (34) is electrically connected to the control module (31); the battery management module (35) is provided with a USB interface (351) for charging; the input end of the bioelectric signal acquisition module (36) is connected to at least one of the circular electrodes (E1~E12) through the connecting line (2), and the signal output end of the bioelectric signal acquisition module (36) is connected to the control module (31).

4. The flexible wearable electrical stimulation device for the knee joint and calf according to claim 1, characterized in that, The reconfigurable connection structure (33) is a switch matrix or multiplexer circuit.

5. The flexible wearable electrical stimulation device for the knee and calf joint according to any one of claims 1 to 4, characterized in that, The flexible fixing component (1) is provided with straps that securely fasten it to the user's legs, and the length of the straps is adjustable.

6. A control method for a flexible wearable knee and calf electrical stimulation device, applied to the flexible wearable knee and calf electrical stimulation device as described in any one of claims 1-5, characterized in that, Includes the following steps: S1: The control module (31) determines the target stimulation area and the corresponding target circular electrode (E1~E12) combination according to the preset or externally input stimulation scheme; S2: The control module (31) sends a channel switching command to the reconfigurable connection structure (33) to connect the stimulation output path of the electrode driving module (32) to the target circular electrode (E1~E12) combination; S3: The control module (31) controls the electrode driving module (32) to generate an electrical stimulation signal with a preset waveform, frequency, pulse width and intensity. The electrical stimulation signal is routed through the reconfigurable connection structure (33) and then transmitted to the target circular electrode (E1~E12) combination through the connection line (2) and finally applied to the human body. S4: During stimulation, the control module (31) dynamically changes the combination of target circular electrodes (E1~E12) and / or stimulation parameters according to the preset timing or external instructions, so as to realize the reconstruction of stimulation path and / or stimulation mode.

7. The control method for the flexible wearable knee and calf electrical stimulation device according to claim 6, characterized in that, In step S1, the target circular electrode (E1~E12) combination is determined by an electrode combination optimization algorithm, including: the control module (31) evaluates the coupling efficiency between each electrode position and the target muscle group based on the electromyographic signal fed back by the bioelectric signal acquisition module (36) or based on the preset anatomical mapping relationship, and preferentially selects the circular electrode (E1~E12) pair with the highest coupling efficiency as the target electrode combination.

8. The control method for the flexible wearable knee and calf electrical stimulation device according to claim 6, characterized in that, The electrical stimulation signal in step S3 is an interference waveform, which is generated by the following method: the control module (31) controls the electrode driving module (32) to generate two or more carrier signals with different frequencies, and outputs the carrier signals of different frequencies to pairs of circular electrodes (E1~E12) at different spatial positions through a reconfigurable connection structure (33), so that the two signals intersect and interfere in the human tissue to produce a low-frequency modulation effect; the frequency difference of the carrier signals is adjustable between 1Hz and 200Hz, and the stimulation depth is controlled by adjusting the frequency difference; The electrical stimulation signal mentioned in step S3 is a high-frequency TIS waveform with a frequency range of 1000Hz to 10000Hz and a pulse width of 50μs to 500μs. High-frequency stimulation reduces skin impedance and achieves deep tissue penetration.

9. The control method for the flexible wearable knee and calf electrical stimulation device according to claim 6, characterized in that, It also includes step S5: the bioelectric signal acquisition module (36) acquires the electromyographic signals of the target muscle group during the stimulation interval, and the control module (31) evaluates the muscle response based on the amplitude and frequency characteristics of the electromyographic signals, and dynamically adjusts the stimulation intensity, frequency or pulse width in step S3 accordingly to achieve closed-loop feedback control; the dynamic adjustment includes: increasing the stimulation intensity when the amplitude of the electromyographic signal is lower than the preset threshold; and reducing the stimulation intensity or pausing stimulation when the amplitude of the electromyographic signal exceeds the safety threshold.

10. The control method for the flexible wearable knee and calf electrical stimulation device according to any one of claims 6 to 9, characterized in that, It also includes step S6: the control module (31) uploads the stimulation process data to the external terminal through the wireless communication module (34) and receives the stimulation scheme update instruction issued by the external terminal.

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