Closed-loop transcutaneous tibial nerve stimulation system based on brain-computer interface and control method thereof, medium

Abstract

The application provides a closed-loop transcutaneous tibial nerve stimulation system based on a brain-computer interface and a control method and medium thereof, wherein the system determines whether a stimulation pulse applied to the tibial nerve of the ankle of a target object through a stimulation electrode reaches the tibial nerve trunk through M waves, determines whether the signal reaches the brain through somatosensory evoked potentials P40, forms a double-condition closed loop in combination of the two, and automatically determines how to adjust the stimulation parameters according to a preset closed-loop control strategy. The application proposes a brand-new double-mode feedback framework of "peripheral M-wave baseline gating + central P40 therapeutic effect verification", which breaks through the limitation of traditional closed loop relying only on peripheral electromyography or subjective feeling. The design starts from the anatomy and function of the neural pathway, ensures that the nerve trunk is physically activated, and verifies the ascending sensory pathway directly related to OAB treatment, effectively improves the limitations of the prior art, improves the reliability of the stimulation effectiveness judgment, and the closed-loop logic is highly matched with the treatment mechanism.

Description

Technical Field

[0001] This application belongs to the field of medical device technology and relates to a closed-loop percutaneous tibial nerve stimulation system based on brain-computer interface and its control method and medium. Background Technology

[0002] Overactive bladder (OAB) is characterized by urinary urgency, frequency, nocturia, and urge incontinence, significantly impacting quality of life. Transcutaneous tibial nerve stimulation (TPNS) is a second-line physical therapy option for OAB, inhibiting bladder overexcitation by stimulating the tibial nerve at the ankle. However, current traditional TPNS systems have the following problems:

[0003] 1) The setting of system stimulation parameters depends on the doctor's experience and the patient's subjective tingling sensation, resulting in large individual differences and poor quantification.

[0004] 2) The system cannot confirm the true activation status of neural pathways in real time, which makes it impossible for the system to accurately determine whether the current stimulation parameters have effectively activated the ascending sensory pathway and the descending motor pathway.

[0005] 3) Skin impedance drift, electrode displacement, and neural excitability adaptation can cause fluctuations in stimulation efficiency, which the system cannot dynamically compensate for. Summary of the Invention

[0006] This application provides a closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, as well as its control method and medium, to solve the problems of existing percutaneous tibial nerve stimulation systems relying on subjective judgment for stimulation parameter settings, being unable to confirm the true activation state of neural pathways in real time, and lacking system fault warnings.

[0007] In a first aspect, this application provides a closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, comprising: a percutaneous tibial nerve stimulation module for applying stimulation pulses to the tibial nerve of a target subject's ankle via stimulation electrodes; a peripheral feedback module for acquiring electromyographic signals at the abductor hallucis muscle of the target subject's foot and extracting M-waves from them; a central feedback module for acquiring electroencephalographic signals from the target subject's head and extracting somatosensory evoked potentials (P40s) from them; and a main control and closed-loop algorithm unit, which is communicatively connected to the percutaneous tibial nerve stimulation module, the peripheral feedback module, and the central feedback module, and is configured to: generate a first state signal representing the activation state of peripheral motor fibers of the tibial nerve based on the M-waves; generate a second state signal representing the activation state of ascending sensory pathways based on the somatosensory evoked potentials (P40s); and generate parameter adjustment instructions according to a preset closed-loop control strategy based on the first state signal and the second state signal, so that the percutaneous tibial nerve stimulation module dynamically adjusts the stimulation parameters according to the parameter adjustment instructions.

[0008] The brain-computer interface-based closed-loop percutaneous tibial nerve stimulation (OAB) system described in this application uses M-waves (as a direct and objective indicator of physical activation of the peripheral nerve trunk) to determine whether the stimulation pulse applied to the tibial nerve in the target's ankle reaches the tibial nerve trunk (i.e., to determine the effectiveness of stimulation). Somatosensory evoked potentials (P40) (a therapeutic effectiveness criterion for activation of ascending sensory pathways) are used to determine whether the signal ascends to the spinal cord and brain (i.e., to determine whether the stimulation truly acts on the core pathway regulating the bladder). The combination of these two methods forms a dual-condition closed loop, and a preset closed-loop control strategy automatically determines how to adjust the stimulation parameters. This application proposes a novel dual-modal feedback framework of "peripheral M-wave baseline gating + central P40 efficacy verification," overcoming the limitations of traditional closed loops that rely solely on peripheral electromyography or subjective perception. This design, starting from the anatomy and function of neural pathways, ensures both physical activation of the nerve trunk and verification of ascending sensory pathways directly related to OAB treatment, effectively improving the limitations of existing technologies, enhancing the reliability of stimulation effectiveness assessment, and ensuring a high degree of alignment between the closed-loop logic and the treatment mechanism.

[0009] In one implementation of the first aspect, the stimulation electrode is configured in a bipolar configuration, wherein the cathode is placed at the midpoint of the line connecting the posterior border of the medial malleolus and the Achilles tendon, and the anode is placed on the medial side of the lower leg 2-3 cm proximal to the cathode.

[0010] In one implementation of the first aspect, the transcutaneous tibial nerve stimulation module includes a constant current stimulation generator that generates the stimulation pulses by outputting a constant current biphasic balanced square wave.

[0011] In one implementation of the first aspect, the peripheral feedback module includes an EMG acquisition electrode; the EMG acquisition electrode includes two recording electrodes and a reference electrode; wherein, the two recording electrodes are arranged along the direction of the abductor hallucis muscle fibers and positioned at the midpoint of the muscle belly below the middle segment of the first metatarsal bone; the reference electrode is positioned at the bony protuberance of the calcaneus.

[0012] In one implementation of the first aspect, the central feedback module employs a configuration of at least four leads; the central feedback module includes EEG acquisition electrodes, each of which includes at least: a recording electrode, two reference electrodes, and a ground electrode; wherein the recording electrode is positioned at the Cz' point corresponding to the primary somatosensory cortex of the lower limb, the two reference electrodes are connected in parallel via bilateral earlobes, and the ground electrode is positioned at the Fpz point on the forehead.

[0013] In one implementation of the first aspect, the main control and closed-loop algorithm unit is further configured to execute an initial calibration procedure: controlling the percutaneous tibial nerve stimulation module to gradually increase the current intensity of the stimulation pulse from an initial value; receiving the M-wave fed back by the peripheral feedback module, and recording the M-wave threshold I corresponding to the first stable occurrence of the M-wave. M; Receive the somatosensory evoked potential P40 fed back by the central feedback module, and record the P40 threshold I corresponding to the first stable detection of the somatosensory evoked potential P40. P Continue increasing the current intensity until the target object experiences pain feedback, and record the corresponding pain threshold I. pain According to the M-wave threshold I M P40 threshold I P and pain threshold I pain The lower and upper limits of the current intensity of the stimulation pulse are determined; the initial stimulation current intensity is determined based on the lower and upper limits.

[0014] In one implementation of the first aspect, the main control and closed-loop algorithm unit is further configured to: during the initial calibration process, when the M-wave threshold I... M When the position of the stimulation electrode is outside the preset normal reference range, a prompt signal for adjustment is generated.

[0015] In one implementation of the first aspect, the main control and closed-loop algorithm unit generates parameter adjustment instructions according to the following closed-loop control strategy: acquiring the first state signal with a first sampling period and comparing it with a first preset threshold interval; acquiring the second state signal with a second sampling period and comparing it with a second preset threshold interval; wherein the second sampling period is greater than the first sampling period; when the first state signal is lower than the lower limit of the first preset threshold interval, generating a first parameter adjustment instruction for gradually increasing the current intensity; when the first state signal is within the first preset threshold interval but the second state signal is lower than the lower limit of the second preset threshold interval, generating a second parameter adjustment instruction for preferentially increasing the pulse width; when the first state signal and the second state signal are respectively within their respective preset threshold intervals, maintaining the current stimulation parameter or generating a third parameter adjustment instruction for maintaining the current stimulation parameter; when the first state signal or the second state signal exceeds the upper limit of their respective preset threshold intervals, generating a fourth parameter adjustment instruction for reducing the current intensity or stopping the generation of the stimulation signal.

[0016] In one implementation of the first aspect, the main control and closed-loop algorithm unit is further configured to generate a stop stimulation command and a stimulation electrode wearing check prompt signal when the stimulation parameters output by the percutaneous tibial nerve stimulation module reach a preset upper limit value and the first state signal and the second state signal do not reach the lower limit of their respective preset threshold intervals.

[0017] In one implementation of the first aspect, the closed-loop percutaneous tibial nerve stimulation system further includes a mobile terminal, and the main control and closed-loop algorithm unit is further provided with a wireless communication module; the mobile terminal is used to communicate with the main control and closed-loop algorithm unit through the wireless communication module.

[0018] In a second aspect, the present application provides a control method for a closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, which is applied to the above-mentioned closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, and the control method comprises:

[0019] During the process of applying stimulation pulses to the tibial nerve at the ankle of a target subject through stimulation electrodes, generating a first state signal characterizing the activation state of peripheral motor fibers of the tibial nerve according to the collected M-wave; generating a second state signal characterizing the activation state of the ascending sensory pathway according to the collected somatosensory evoked potential P40; generating a parameter adjustment instruction according to the first state signal and the second state signal in accordance with a preset closed-loop control strategy, so that the percutaneous tibial nerve stimulation module dynamically adjusts stimulation parameters in accordance with the parameter adjustment instruction.

[0020] In a third aspect, the present application provides a computer-readable storage medium, on which a computer program is stored, and when the computer program is executed, the above-mentioned control method for the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface is implemented.

[0021] As described above, the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, the control method thereof, and the medium according to the present application have the following beneficial effects:

[0022] 1) A novel dual-modality feedback framework of "peripheral M-wave baseline gating + central P40 therapeutic effect verification" is proposed, which breaks through the limitation of traditional closed loops that only rely on peripheral electromyography or subjective perception. This design starts from the anatomy and function of the neural pathway, not only ensuring that the nerve trunk is physically activated, but also verifying the ascending sensory pathway directly related to bladder function regulation, so that the closed-loop logic is highly matched with the regulation mechanism.

[0023] 2) Based on the difference in excitability of nerve fibers (i.e., Aα motor fiber threshold < Aβ sensory fiber threshold < nociceptive fiber threshold), through the M-wave threshold I M , P40 threshold I P and nociceptive threshold I pain three threshold nodes are accurately defined to realize quantitative anchoring of stimulation intensity, thereby replacing the traditional vague judgment that relies on the patient's tingling sensation, and improving the standardization and repeatability of stimulation parameter setting.

[0024] 3) M-waves do not require averaging and can be detected with a single stimulus, with activation verification completed every second. When the stimulus intensity is below the M-wave threshold or the M-wave disappears, the system can directly determine "peripheral pathway disconnection" without waiting for the somatosensory evoked potential (P40) results, immediately implementing a step-by-step increase in current intensity to quickly respond to transient interferences such as electrode displacement and impedance fluctuations. The somatosensory evoked potential (P40) is evaluated every 20 seconds, providing central-level efficacy verification. The dual-scale design balances real-time performance and accuracy, achieving dynamic compensation for fluctuations in stimulus efficiency.

[0025] 4) The stable presence of the M wave is a prerequisite for the effective detection of somatosensory evoked potential P40. If the M wave disappears, it indicates that the peripheral nerves themselves are not activated. In this case, the disappearance of somatosensory evoked potential P40 is a peripheral conduction problem, not a central pathway problem. Based on this, the system can avoid misjudging "peripheral inactivation" as "insufficient sensory pathway activation" and blindly increasing the current, thus preventing parameter adjustments from deviating from the actual problem.

[0026] 5) By using a minimalist EEG configuration with at least four leads (including: recording electrodes corresponding to the Cz′ point of the primary somatosensory cortex of the lower limbs, reference electrodes connected in parallel on both earlobes, and ground electrodes set at the Fpz point on the forehead) and dry electrode technology, the SEP test, which could only be performed in the neurophysiology laboratory of a hospital, is transformed into a home-wearable monitoring module. This allows the closed-loop feedback at the central level to move out of the laboratory and provides a feasible path for the "centralized closed loop" of wearable neuromodulation devices. Attached Figure Description

[0027] Figure 1 The diagram shows a schematic of the module structure of the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface as described in this application.

[0028] Figure 2 This diagram illustrates the ascending sensory pathway in a closed-loop percutaneous tibial nerve stimulation system.

[0029] Figure 3 The diagram shown is a schematic representation of the hardware system structure of a specific embodiment of the brain-computer interface-based closed-loop percutaneous tibial nerve stimulation system described in this application.

[0030] Figure 4 Displayed as Figure 3 A schematic diagram showing the positioning of the stimulation electrodes in the percutaneous tibial nerve stimulation module of the hardware system structure shown.

[0031] Figure 5 Displayed as Figure 3 The diagram shows the positioning of the EMG acquisition electrode in the peripheral feedback module of the hardware system structure shown.

[0032] Figure 6 Displayed as Figure 3The diagram shows the positioning of the EEG acquisition electrodes in the central feedback module of the hardware system structure.

[0033] Figure 7 The diagram shown is a schematic representation of the hardware system structure of another specific embodiment of the brain-computer interface-based closed-loop percutaneous tibial nerve stimulation system described in this application.

[0034] Figure 8 The diagram shown is a flowchart illustrating the control method of the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface as described in this application. Detailed Implementation

[0035] The following specific examples illustrate the implementation of this application. Those skilled in the art can easily understand other advantages and effects of this application from the content disclosed in this specification. This application can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of this application. It should be noted that, unless otherwise specified, the following embodiments and features in the embodiments can be combined with each other.

[0036] It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of this application. Therefore, the drawings only show the components related to this application and are not drawn according to the number, shape and size of the components in actual implementation. In actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0037] The technical solutions in the embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0038] like Figure 1 The diagram shown is a schematic of the module structure of the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface as described in this application.

[0039] refer to Figure 1 In this embodiment, the brain-computer interface-based closed-loop percutaneous tibial nerve stimulation system 1 includes: a percutaneous tibial nerve stimulation module 11, a peripheral feedback module 12, a central feedback module 13, and a master control and closed-loop algorithm unit 14. The percutaneous tibial nerve stimulation module 11 and the peripheral feedback module 12 serve as the master control terminal, preferably integrated on the same circuit board (PCB) or packaged in the same housing, but they can also be located on different circuit boards or packaged in different housings. The central feedback module 13 serves as an independent miniature acquisition module, maintaining synchronization with the master control terminal via wireless communication (e.g., Bluetooth).

[0040] Specifically, the percutaneous tibial nerve stimulation module 11 is used to apply stimulation pulses to the tibial nerve in the ankle of the target subject through stimulation electrodes. The peripheral feedback module 12 is used to collect electromyographic signals at the abductor hallucis muscle of the target subject's foot and extract M waves from them. The central feedback module 13 is used to collect electroencephalographic signals from the target subject's head and extract somatosensory evoked potentials P40 from them.

[0041] Those skilled in the art will understand that the tibial nerve is a mixed nerve, containing both motor and sensory fibers, and its core pathway for regulating bladder function is the ascending sensory pathway, such as... Figure 2 The diagram shows the neural pathway of the ascending sensory pathway in a closed-loop percutaneous tibial nerve stimulation system. (Reference) Figure 2 The neural pathway of the ascending sensory pathway is as follows: Aβ sensory fiber of the tibial nerve → posterior column of the spinal cord → medial lemniscus → ventral posterior nucleus of the thalamus → primary somatosensory cortex of the brain → pontine micturition center / sacral micturition center → inhibition of bladder overactivity.

[0042] If only the M-wave is used as feedback, it only proves that Aα motor fibers are activated, not that Aβ sensory fibers are also activated. Furthermore, activation of the descending motor pathway alone does not directly equate to effective regulation of bladder overactivity. Conversely, if only the somatosensory evoked potential P40 is used as feedback, although it can prove that the ascending sensory pathway is activated, P40 requires multiple averagings to detect (approximately 20 seconds), resulting in a slow response and inability to quickly address transient interferences such as electrode displacement and impedance abrupt changes. Therefore, the activation status of both ascending and descending pathways needs to be verified separately.

[0043] Specifically, verifying the activation status of the descending motor pathway involves using the M-wave of the abductor hallucis muscle as the minimum criterion for determining the effectiveness of stimulation. The M-wave refers to the compound muscle action potential triggered by the direct excitation of Aα motor fibers through stimulation of the tibial nerve trunk, followed by anterograde conduction of the impulse to the abductor hallucis muscle. Because the M-wave has a short latency (typically 3-6 ms) and a stable waveform, it is a direct and objective marker of physical activation of the peripheral nerve trunk and can therefore serve as a "baseline gating" for stimulation effectiveness.

[0044] Verifying the activation status of the ascending sensory pathway uses cortical somatosensory evoked potentials (P40) as the gold standard electrophysiological indicator. Specifically, P40 refers to the positive cortical potential recorded approximately 40 ms after stimulation of the tibial nerve to excite Aβ sensory fibers, which then ascend along the spinal cord to the subcortical limb sensory area. This P40 directly corresponds to the core mechanism of OAB therapy and can serve as a "central verification" of treatment effectiveness.

[0045] The main control and closed-loop algorithm unit 14 is communicatively connected to the transcutaneous tibial nerve stimulation module 11, the peripheral feedback module 12, and the central feedback module 13, respectively. It is configured to: generate a first state signal representing the activation state of the peripheral motor fibers of the tibial nerve based on the M-wave; generate a second state signal representing the activation state of the ascending sensory pathway based on the somatosensory evoked potential P40; and generate parameter adjustment instructions according to a preset closed-loop control strategy based on the first and second state signals, so that the transcutaneous tibial nerve stimulation module 11 dynamically adjusts the stimulation parameters according to the parameter adjustment instructions. It should be noted that in this embodiment, the order in which the first and second state signals are generated is not limited.

[0046] In this embodiment, the core logic of the closed-loop control strategy preset by the master control and closed-loop algorithm unit 14 is: using the M wave to determine whether the stimulus reaches the tibial nerve trunk (i.e., peripheral gating), and using the somatosensory evoked potential P40 to determine whether the sensory signal can ascend to the central cortex (central verification). The two are combined to form a dual-condition closed loop, and the stimulation parameters are automatically adjusted according to the preset closed-loop control strategy.

[0047] Specifically, the main control and closed-loop algorithm unit 14 generates parameter adjustment instructions according to the following closed-loop control strategy:

[0048] Step 1421: Acquire the first state signal with a first sampling period and compare it with a first preset threshold interval.

[0049] Step 1422: Acquire the second state signal with a second sampling period and compare it with a second preset threshold interval; wherein the second sampling period is greater than the first sampling period.

[0050] Step 1423: When the first state signal is lower than the lower limit of the first preset threshold range, a first parameter adjustment command is generated to gradually increase the current intensity.

[0051] Step 1424: When the first state signal is within the first preset threshold range but the second state signal is below the lower limit of the second preset threshold range, a second parameter adjustment command is generated to preferentially increase the pulse width.

[0052] Step 1425: When the first state signal and the second state signal are respectively within their respective preset threshold ranges, maintain the current stimulation parameters or generate a third parameter adjustment command to maintain the current stimulation parameters.

[0053] Step 1426: When the first state signal or the second state signal exceeds the upper limit of its respective preset threshold range, a fourth parameter adjustment command is generated to reduce the current intensity or stop generating the stimulation signal.

[0054] Specifically, in step 1421, the first state signal (i.e., the M-wave activation index) is acquired at a first sampling period (e.g., once every 1 second) and compared with a first preset threshold range (e.g., a lower limit of 0.3 and an upper limit of 0.9).

[0055] In step 1423, when the first state signal is lower than the lower limit of the first preset threshold range (i.e., the M-wave activation index is <0.3 or the M-wave disappears), it is determined that the peripheral nerve activation is insufficient, and a first parameter adjustment instruction is generated to gradually increase the current intensity (e.g., gradually increase the current intensity in 0.2mA steps) until the M-wave activation index recovers to above the second preset threshold (e.g., 0.5).

[0056] In step 1422, the second state signal (i.e., the P40 activation index) is acquired at a second sampling period (e.g., once every 20 seconds) and compared with a second preset threshold range (e.g., a lower limit of 0.4 and an upper limit of 0.9). Since the closed-loop control strategy in this embodiment adopts a dual-scale adjustment strategy of "high-frequency peripheral gating + low-frequency central verification," balancing real-time performance and accuracy, the sampling of the M-wave needs to achieve a fast response, and low-frequency central verification is used for P40. Therefore, the second sampling period in this embodiment is longer than the first sampling period.

[0057] In step 1424, when the first state signal is within the first preset threshold range but the second state signal is below the lower limit of the second preset threshold range (i.e., the M-wave meets the standard but P40 does not), it is determined that only the Aα motor fibers of the descending motor pathway are activated, and the Aβ sensory fibers of the ascending sensory pathway are insufficiently activated. Therefore, a second parameter adjustment instruction is generated to preferentially increase the stimulation pulse width (e.g., by 20 μs each time), thereby increasing the excitation efficiency of the thin-diameter Aβ sensory fibers by extending the stimulation duration. If the pulse width reaches the preset upper limit (e.g., 400 μs) and still does not meet the standard, the current intensity is slightly increased until the P40 activation index is ≥0.4.

[0058] In step 1425, when the first state signal and the second state signal are respectively within their preset threshold ranges (i.e., both pathways meet the criteria), the current stimulation parameters are maintained or a third parameter adjustment instruction for maintaining the current stimulation parameters is generated. Maintaining the current stimulation parameters means that no parameter adjustment instruction needs to be generated; the system will continue to maintain the current stimulation parameters. Generating a third parameter adjustment instruction for maintaining the current stimulation parameters means that even if the current stimulation parameters are maintained, the third parameter adjustment instruction is still generated (only this adjustment instruction is a maintenance instruction).

[0059] In step 1426, when the first state signal or the second state signal exceeds the upper limit of its respective preset threshold range (for example, when the M-wave activation index > 0.9 or the target object shows discomfort), a fourth parameter adjustment command is generated to reduce the current intensity or stop generating the stimulation signal.

[0060] Furthermore, when the intensity of the stimulation pulse is below the motor threshold, an M-wave will not appear (i.e., insufficient activation of Aα motor fibers), but P40 can still be elicited (as long as Aβ sensory fibers are activated). This is a common operating condition for TTNS treatment of OAB. In other words, even without an M-wave, P40 can still occur, but if an M-wave does appear, its appearance time will be significantly earlier than P40.

[0061] In this embodiment, the main control and closed-loop algorithm unit 14 is further configured to generate a stop stimulation command and a stimulation electrode wearing check prompt signal (i.e., set a safety circuit breaker mechanism) when the stimulation parameters output by the percutaneous tibial nerve stimulation module 11 reach the preset upper limit value and the first state signal and the second state signal do not reach the lower limit of their respective preset threshold ranges, so as to avoid ineffective stimulation and skin damage to the target object.

[0062] The closed-loop control strategy described in this embodiment avoids drastic parameter fluctuations through layered and gradual adjustments, which conforms to the safety principle of neural stimulation.

[0063] Furthermore, the main control and closed-loop algorithm unit 14 is also configured to execute an initial calibration process, which includes the following steps:

[0064] Step 1411: Control the percutaneous tibial nerve stimulation module 11 to gradually increase the current intensity of the stimulation pulse from an initial value (e.g., 0mA).

[0065] Step 1412: Receive the M-wave fed back by the peripheral feedback module 12, and record the current intensity corresponding to the first stable occurrence of the M-wave, denoted as the M-wave threshold I. M .

[0066] Wearing verification during the calibration phase: During the first wear, the I of the tibial nerve in the ankle of the healthy target subject...M Typically 2~6mA. If the measured I... M If the value is significantly higher than this range, it indicates that the electrode is off-center from the nerve trunk projection line, the skin stratum corneum is too thick, or the electrode contact is poor. The main control and closed-loop algorithm unit 14 generates a prompt signal for adjusting the wearing position of the stimulation electrode to guide the target object to readjust the wearing position.

[0067] Step 1413: Receive the somatosensory evoked potential P40 fed back by the central feedback module 13, and record the current intensity corresponding to the first stable detection of the somatosensory evoked potential P40, denoted as P40 threshold I. P .

[0068] Step 1414: Continue increasing the current intensity until the target object experiences pain feedback. Record the corresponding current intensity, which is the pain threshold I. pain .

[0069] Step 1415: Based on the M-wave threshold I M P40 threshold I P and pain threshold I pain The lower and upper limits of the current intensity of the stimulation pulse are determined.

[0070] For example, the effective lower limit is I P (i.e., activation of the ascending sensory pathway), with a safe upper limit of 0.8 × I pain (Avoid pain and nerve damage to the target subject).

[0071] Step 1416: Determine the initial stimulation current intensity based on the lower limit and the upper limit.

[0072] Specifically, the initial stimulation current intensity can be set to the median value between the lower and upper limits, for example, I0 = I P + 0.5×(0.8×I pain - I P Then, the M-wave and P40 baseline characteristics from the initial calibration phase are saved as a reference for subsequent closed-loop control adjustments.

[0073] In this embodiment, the M-wave threshold I M It also acts as a millisecond-level gate: on the one hand, M-waves do not require superposition and averaging, and can be detected with a single stimulus, completing an activation check every second. When the stimulus intensity is lower than I... M When the M-wave disappears, the system can respond quickly without waiting for the P40 result. On the other hand, when the M-wave is stable (intensity ≥ I), the system can respond quickly. M The presence of M waves is a prerequisite for effective P40 detection. If the M waves disappear, it indicates that the peripheral nerves themselves are not activated, which can prevent the closed-loop algorithm from misjudging as insufficient activation of the ascending sensory pathway and blindly increasing the current.

[0074] In this embodiment, the I M It can also be used for quantitative monitoring of neural adaptation and individualized estimation of safety boundaries. Under long-term repeated stimulation, neural excitability will undergo habituation adaptation, manifesting as I... M Gradually increase, through periodic retesting I M The degree of neural adaptation can be quantified and stimulation parameters dynamically adjusted. Clinical data show that the pain threshold for percutaneous tibial nerve stimulation is typically I [a certain value is missing here, likely indicating an individual context]. M It is 3 to 5 times that of I, therefore the maximum output current can be limited to 4 × I M While ensuring full activation, it is important to avoid pain and nerve damage in the target subject.

[0075] In this embodiment, if the M-wave disappears or the equivalent I-wave disappears under the original current intensity... M An increase of more than 20% can be quickly identified as electrode displacement or impedance drift caused by skin sweating / dryness, triggering the system's stimulation parameter compensation or issuing a wearing reminder signal.

[0076] The initial calibration process described in this embodiment establishes an individualized stimulation parameter working window for each target object, eliminating the influence of anatomical and physiological differences and realizing the quantitative anchoring of stimulation intensity.

[0077] Furthermore, the main control and closed-loop algorithm unit 14 is also configured to execute a long-term adaptive optimization process.

[0078] Specifically, after each operation, the main control and closed-loop algorithm unit 14 records the sequence of stimulation parameters output during each run (including current intensity, pulse width, stimulation frequency, etc.), the first state signal sequence (i.e., M-wave activation index), the second state signal sequence (i.e., P40 activation index), and diary data (e.g., voiding diary) input by the target subject from external sources. Then, the main control and closed-loop algorithm unit 14 establishes an individualized prediction model through a lightweight machine learning model to gradually optimize the target activation range. For example, when statistics show that the improvement in nocturia is most significant when the P40 activation index of a target subject is maintained at 0.5~0.6, this index range is automatically set as the new control target. The long-term adaptive optimization process described in this embodiment achieves dynamic optimization of the individualized control target through machine learning, further improving the accuracy and individualization of the system. The M-wave activation index is defined as: current amplitude / individual maximum M-wave amplitude, ranging from 0 to 1, used to quantify the activation level of peripheral pathways. The P40 activation index is defined as: the current amplitude / the P40 amplitude under the maximum tolerance intensity of the target individual, ranging from 0 to 1, and is used to quantify the degree of activation of the central sensory pathway.

[0079] The specific module structure of the closed-loop percutaneous tibial nerve stimulation system based on brain-computer interface provided in this application will be described in detail below with reference to specific embodiments.

[0080] like Figure 3 The diagram shown is a schematic representation of the hardware system structure of a specific embodiment of the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface described in this application.

[0081] refer to Figure 3 In the brain-computer interface-based closed-loop percutaneous tibial nerve stimulation system 2 described in this embodiment, the percutaneous tibial nerve stimulation module 211 and the peripheral feedback module 212 are integrated on the same circuit board (PCB) or packaged on the same housing (e.g., Figure 2 The ankle stimulation-EMG acquisition module 21 can be worn on the ankle of the target subject. Figure 2 As shown, the two can share the same MCU (e.g. Figure 2 The first main control and closed-loop algorithm unit 213), power management (such as...) Figure 2 The power management 214 in the middle can be in the form of a built-in rechargeable lithium battery, which can support more than 10 times of 30 minutes of operation on a single charge, but the peripheral feedback module 212 maintains an independent analog front end (such as Figure 2 The EMG signal AFE analog front-end circuit 2122 and ADC analog-to-digital converter 2123 are included.

[0082] Specifically, the percutaneous tibial nerve stimulation module 211 is used to apply stimulation pulses to the tibial nerve in the ankle of the target subject via stimulation electrodes 2112. In this embodiment, the stimulation electrodes 2122 adopt a bipolar configuration, precisely corresponding to the surface projection of the tibial nerve in the ankle. Combined with... Figure 4 shown Figure 3 A schematic diagram showing the positioning of the stimulation electrodes in the percutaneous tibial nerve stimulation module of the hardware system structure shown. (Reference) Figure 4 ,cathode( Figure 4 The blue electrode contact located at the bottom is positioned at the midpoint of the line connecting the posterior border of the medial malleolus and the Achilles tendon (the most superficial part of the tibial nerve trunk), the anode ( Figure 4 The blue electrode contact (located at the top) is positioned 2-3 cm proximal to the cathode on the inner side of the lower leg to ensure the current field passes vertically through the tibial nerve trunk, enhancing excitation efficiency. The stimulation electrode 2112 is a medical-grade flexible silver-plated silver chloride (Ag / AgCl) thin-film electrode integrated into an elastic ankle bandage. The electrode diameter is 8 mm, and it is equipped with a low-sensitivity hydrogel layer to reduce contact resistance and skin irritation. The bipolar focusing design reduces current diffusion and avoids accidental activation of adjacent nerves (such as the common peroneal nerve); the flexible material adapts to ankle movement, reducing the risk of electrode displacement.

[0083] In this embodiment, the percutaneous tibial nerve stimulation module 211 includes a constant current stimulation generator 2111, which uses a constant current output biphasic balanced square wave to generate the stimulation pulse, thereby avoiding skin electrolysis and nerve damage caused by direct current components. The adjustable range of the stimulation parameters of the stimulation pulse is as follows:

[0084] 1) Parameter type: current intensity; adjustable range: 0~25mA, step 0.1mA (default value is 5mA). The physiological significance of the parameter is to determine the number and type of nerve fibers activated.

[0085] 2) Parameter type: Pulse width; adjustable range: 100~500μs, step 10μs (default value is 200μs). The physiological significance of the parameter is to affect the excitation threshold of nerve fibers of different diameters.

[0086] 3) Parameter type: Stimulation frequency; adjustable range: 2~20Hz, step 1Hz (default value is 10Hz). The physiological significance of the parameter is to match the regulatory rhythm of the spinal micturition center.

[0087] 4) Parameter type: treatment duration; adjustable range: 10~60min (default value is 30min). The physiological meaning of the parameter is consistent with the routine clinical treatment plan.

[0088] The peripheral feedback module 212 is used to collect electromyographic (EMG) signals from the abductor hallucis muscle of the target object and extract the M-wave from them. The EMG signal is a bioelectrical signal formed by the temporal and spatial superposition of skeletal muscle motor unit action potentials (MUAPs), which can be non-invasively acquired via surface electrodes. This signal reflects the electrical activity during muscle contraction and includes information such as activation timing and contraction intensity.

[0089] The peripheral feedback module 212 includes an EMG acquisition electrode 2121. The EMG acquisition electrode 2121 employs a three-electrode configuration, including two recording electrodes (e.g., ...). Figure 3 The diagram shows recording electrode 1 and recording electrode 2, and a reference electrode. Figure 5 What is shown is Figure 3 The diagram shows the positioning of the EMG acquisition electrodes in the peripheral feedback module of the hardware system structure. (Refer to reference...) Figure 5 The two recording electrodes are recording electrode 1 and recording electrode 2 (corresponding to as shown in the figure). Figure 5The two bipolar recording electrodes (positions 51 and 52) are arranged along the muscle fiber direction of the abductor hallucis muscle, located at the midpoint of the muscle belly below the middle segment of the first metatarsal bone, with a center-to-center distance of 10 mm. The reference electrode (corresponding to position 53 in the figure) is placed at the calcaneal tuberosity, an area with no skeletal muscle distribution and extremely weak bioelectrical activity, providing a stable zero-potential reference. The arrangement of the bipolar recording electrodes along the muscle fiber direction of the abductor hallucis muscle maximizes the acquisition of the differential signal amplitude of the M-wave while suppressing power line interference and motion artifacts.

[0090] The hardware parameters of the peripheral feedback module 212 include: the EMG signal AFE analog front-end circuit 2122 uses a high input impedance instrumentation amplifier, with a common-mode rejection ratio (CMRR) > 100dB, a sampling rate of 2kHz, and a bandwidth of 10~1000Hz. A 16-bit ADC analog-to-digital converter 2123 is used for analog-to-digital conversion, and a hardware bandpass filter is provided. Figure 2 (Not shown in the image), used for initial filtering of power frequency interference and baseline drift.

[0091] The EEG acquisition front-end 22 includes a central feedback module 221 and a second main control and closed-loop algorithm unit 222; wherein, the second main control and closed-loop algorithm unit 222 and the first main control and closed-loop algorithm unit 213 in the ankle stimulation-EMG acquisition module 21 are... Figure 1 The main control and closed-loop algorithm unit 14 shown is logically divided into two logical sub-units. The first main control and closed-loop algorithm unit 213 and the second main control and closed-loop algorithm unit 222 can synchronize and transmit data through wired or wireless communication, and jointly realize the functions of the initial calibration process, parameter adjustment instruction generation based on closed-loop control strategy, and long-term adaptive optimization process of the main control and closed-loop algorithm unit 14 described above.

[0092] The central feedback module 221 includes EEG acquisition electrodes 2211, which are used to acquire electroencephalogram (EEG) signals from the head of the target subject and extract the somatosensory evoked potential P40 from them. EEG signals are weak bioelectrical signals generated by the activity of brain neurons, recorded on the scalp surface by electrodes, and used to reflect the functional state of the brain. The central feedback module 221 employs at least a four-lead configuration, and the EEG acquisition electrodes include at least one recording electrode and two reference electrodes (e.g., ...). Figure 3 The reference electrode 1 and reference electrode 2 are in the middle, and a ground electrode is in the middle.

[0093] Combination such as Figure 6 What is shown is Figure 3 A schematic diagram showing the positioning of the EEG acquisition electrodes in the central feedback module of the hardware system architecture shown. (Reference) Figure 6 The recording electrode is positioned at point Cz′ on the head of the target object. Figure 6 The Cz′ point (located at point number 61) is 2 cm posterior to the central point (Cz point) as defined by the international 10-20 or 10-10 system electrode placement method (i.e., the standard electrode placement method specified by the International Society for Electroencephalography), corresponding to the primary somatosensory cortex of the lower limb. The two reference electrodes A1 and A2 are connected in parallel via bilateral earlobes. Figure 6 The ground electrode is located at two points numbered 63 and 64 in the center (to reduce reference noise). The ground electrode is positioned at the forehead Fpz point specified by the international 10-20 or 10-10 system electrode placement method. Figure 6 (Location point number 62). In practical applications, the EEG acquisition electrode 2211 can be a headband-style dry electrode EEG cap, which does not require conductive gel and can be worn by the target subject. In other embodiments, the positioning of the EEG acquisition electrode can also be set directly according to the international 10-20 system or 10-10 system electrode placement method.

[0094] The hardware parameters of the central feedback module 221 include: a 24-bit high-precision ADC analog-to-digital converter 2213; a sampling rate of 500Hz for the EEG signal AFE analog front-end circuit 2212; a common-mode rejection ratio (CMRR) > 120dB; a bandwidth of 0.5~30Hz; and a hardware 50Hz power frequency notch filter. Figure 3 (Not shown in the image).

[0095] After acquiring the EEG signal, the central feedback module 221 also performs the following signal processing steps: signal enhancement using a stimulus-triggered superposition averaging technique, including: extracting a 0-100ms EEG segment after each stimulus, removing eye movement / EMG artifacts with amplitudes exceeding ±100μV, and superimposing 50-200 stimulus signals to improve the signal-to-noise ratio by more than 10 times. In the superimposed waveform, the positive peak within a 35-45ms time window after stimulation is located, and the latency and peak-to-peak amplitude of the somatosensory evoked potential P40 (the difference relative to the N30 negative wave) are extracted. The activation criteria for the somatosensory evoked potential P40 are: latency falling within the individual calibration value ±5ms; amplitude greater than 2.5 times the standard deviation of the baseline noise; and stable waveform morphology, with repeated detection after three consecutive superpositions.

[0096] like Figure 7 The diagram shown is a schematic representation of the hardware system structure of another specific embodiment of the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface described in this application.

[0097] and Figure 1 and Figure 3The difference in the illustrated embodiment is that, in this embodiment, the closed-loop percutaneous tibial nerve stimulation system 1' further includes a mobile terminal 23, and the main control and closed-loop algorithm unit 14' is further provided with a wireless communication module 141'; the mobile terminal 23 is used to communicate with the main control and closed-loop algorithm unit 14' through the wireless communication module 141'.

[0098] Specifically, the closed-loop percutaneous tibial nerve stimulation system 1' adopts a distributed hardware architecture. It includes: a percutaneous tibial nerve stimulation module 11, a peripheral feedback module 12, a central feedback module 13, and a main control and closed-loop algorithm unit 14'. The percutaneous tibial nerve stimulation module 11 and the peripheral feedback module 12 serve as the main control terminal and can be integrated on the same circuit board (PCB) or packaged in the same housing, or they can be located on different circuit boards or packaged in different housings. The main control and closed-loop algorithm unit 14' also includes a wireless communication module 141' (e.g., a Bluetooth module), allowing the mobile terminal 23 to synchronize and transmit data with the main control and closed-loop algorithm unit 14' via wireless communication (e.g., Bluetooth transmission). It should be noted that in this system, the stimulation circuit (the circuit through which the percutaneous tibial nerve stimulation module 11 applies stimulation pulses to the tibial nerve of the target's ankle via stimulation electrodes) is completely electrically isolated from all acquisition circuits (including M-wave and P40 acquisition circuits), using isolated power supplies and isolated amplifiers to prevent stimulation current from entering the acquisition circuit and causing interference and safety risks. The specific implementation methods of each module in this embodiment can be referred to the above. Figure 3 or Figure 3 The embodiments described herein will not be elaborated upon here.

[0099] This application also provides a control method for a closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, which is applied to the brain-computer interface-based closed-loop percutaneous tibial nerve stimulation system described above.

[0100] like Figure 8 The diagram shown is a flowchart illustrating the control method of the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface as described in this application.

[0101] refer to Figure 8 The control method includes:

[0102] Step S701: During the process of applying stimulation pulses to the tibial nerve of the target's ankle through stimulation electrodes, a first state signal characterizing the activation state of the peripheral motor fibers of the tibial nerve is generated based on the acquired M wave.

[0103] Step S702: Generate a second state signal representing the activation state of the ascending sensory pathway based on the collected somatosensory evoked potential P40.

[0104] Step S703: Based on the first state signal and the second state signal, generate parameter adjustment instructions according to a preset closed-loop control strategy, so that the percutaneous tibial nerve stimulation module dynamically adjusts the stimulation parameters according to the parameter adjustment instructions.

[0105] The execution entity of the method steps described in this embodiment is the master control and closed-loop algorithm unit of the brain-computer interface-based closed-loop percutaneous tibial nerve stimulation system. The specific implementation of each step can be referred to the above. Figure 1 The specific description of the main control and closed-loop algorithm units in the embodiments will not be elaborated here.

[0106] The scope of protection of the control method for the closed-loop percutaneous tibial nerve stimulation system based on brain-computer interface described in this application is not limited to the execution order of the steps listed in this embodiment. Any solution implemented by adding, subtracting, or replacing steps in the prior art based on the principles of this application is included within the scope of protection of this application.

[0107] In the embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, or methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative. For instance, the division of modules / units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple modules or units may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection of apparatuses or modules or units may be electrical, mechanical, or other forms.

[0108] The modules / units described as separate components may or may not be physically separate. The components shown as modules / units may or may not be physical modules; that is, they may be located in one place or distributed across multiple network units. Some or all of the modules / units can be selected to achieve the objectives of the embodiments of this application, depending on actual needs. For example, the functional modules / units in the various embodiments of this application may be integrated into one processing module, or each module / unit may exist physically separately, or two or more modules / units may be integrated into one module / unit.

[0109] Those skilled in the art will further recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, computer software, or a combination of both. To clearly illustrate the interchangeability of hardware and software, the components and steps of the various examples have been generally described in terms of functionality in the foregoing description. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0110] This application also provides a computer-readable storage medium storing a computer program that, when executed, implements the control method for the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface as described above. Those skilled in the art will understand that all or part of the steps in the methods of the above embodiments can be implemented by a program instructing a processor. The program can be stored in a computer-readable storage medium, which is a non-transitory medium, such as random access memory, read-only memory, flash memory, hard disk, solid-state drive, magnetic tape, floppy disk, optical disk, and any combination thereof. The storage medium can be any available medium accessible to a computer or a data storage device such as a server or data center that integrates one or more available media. The available medium can be a magnetic medium (e.g., floppy disk, hard disk, magnetic tape), an optical medium (e.g., digital video disc (DVD)), or a semiconductor medium (e.g., solid-state disk (SSD)).

[0111] The descriptions of the processes or structures corresponding to the above figures each have their own emphasis. For parts of a process or structure that are not described in detail, please refer to the relevant descriptions of other processes or structures.

[0112] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this application should still be covered by the claims of this application.

Claims

1. A closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, characterized in that, include: The transcutaneous tibial nerve stimulation module is used to apply stimulation pulses to the tibial nerve in the ankle of the target subject via stimulation electrodes; The peripheral feedback module is used to collect electromyographic signals from the abductor hallucis muscle of the target object and extract the M wave from them; The central feedback module is used to collect the electroencephalogram (EEG) signals from the head of the target subject and extract the somatosensory evoked potential P40 from them. The main control and closed-loop algorithm unit is communicatively connected to the transcutaneous tibial nerve stimulation module, the peripheral feedback module, and the central feedback module, respectively. It is configured to: generate a first state signal representing the activation state of the peripheral motor fibers of the tibial nerve based on the M-wave; generate a second state signal representing the activation state of the ascending sensory pathway based on the somatosensory evoked potential P40; and generate parameter adjustment instructions according to a preset closed-loop control strategy based on the first state signal and the second state signal, so that the transcutaneous tibial nerve stimulation module dynamically adjusts the stimulation parameters according to the parameter adjustment instructions.

2. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 1, characterized in that, The stimulation electrodes are bipolar, with the cathode placed at the midpoint of the line connecting the posterior border of the medial malleolus and the Achilles tendon, and the anode placed 2-3 cm proximal to the cathode on the medial side of the lower leg.

3. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 1, characterized in that, The percutaneous tibial nerve stimulation module includes a constant current stimulation generator, which generates the stimulation pulses using a constant current output biphasic balanced square wave.

4. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 1, characterized in that, The peripheral feedback module includes an EMG acquisition electrode; the EMG acquisition electrode includes two recording electrodes and one reference electrode; wherein, the two recording electrodes are arranged along the direction of the abductor hallucis muscle fibers and positioned at the midpoint of the muscle belly below the middle segment of the first metatarsal bone; the reference electrode is placed at the bony protuberance of the calcaneus.

5. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 1, characterized in that, The central feedback module adopts a configuration of at least four leads; The central feedback module includes an EEG acquisition electrode, which includes at least one recording electrode, two reference electrodes, and one ground electrode. The recording electrode is positioned at the Cz' point of the primary somatosensory cortex of the lower limb, the two reference electrodes are connected in parallel via bilateral earlobes, and the ground electrode is positioned at the Fpz point of the forehead.

6. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 1, characterized in that, The main control and closed-loop algorithm unit is also configured to perform an initial calibration process: The transcutaneous tibial nerve stimulation module is controlled to gradually increase the current intensity of the stimulation pulse from an initial value; The system receives the M-wave fed back by the peripheral feedback module and records the M-wave threshold I corresponding to the first stable occurrence of the M-wave. M ; The somatosensory evoked potential P40 fed back by the central feedback module is received, and the P40 threshold I corresponding to the first stable detection of the somatosensory evoked potential P40 is recorded. P ; continue When the current intensity is increased until the target object experiences pain feedback, the corresponding pain threshold I is recorded. pain ; According to the M-wave threshold I M P40 threshold I P and pain threshold I pain Determine the lower and upper limits of the current intensity of the stimulation pulse; The initial stimulation current intensity is determined based on the lower and upper limits.

7. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 6, characterized in that, The main control and closed-loop algorithm unit is further configured to: during the initial calibration process, when the M-wave threshold I... M When the position of the stimulation electrode is outside the preset normal reference range, a prompt signal for adjustment is generated.

8. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 1, characterized in that, The main control and closed-loop algorithm unit generates parameter adjustment instructions according to the following closed-loop control strategy: The first state signal is acquired during the first sampling period and compared with a first preset threshold interval; The second state signal is acquired with a second sampling period and compared with a second preset threshold interval; wherein the second sampling period is greater than the first sampling period. When the first state signal is lower than the lower limit of the first preset threshold range, a first parameter adjustment command is generated to gradually increase the current intensity. When the first state signal is within the first preset threshold range but the second state signal is below the lower limit of the second preset threshold range, a second parameter adjustment command is generated to prioritize increasing the pulse width. When the first state signal and the second state signal are respectively within their respective preset threshold ranges, the current stimulation parameters are maintained or a third parameter adjustment command is generated to maintain the current stimulation parameters. When the first state signal or the second state signal exceeds the upper limit of its respective preset threshold range, a fourth parameter adjustment command is generated to reduce the current intensity or stop generating the stimulation signal.

9. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 8, characterized in that, The main control and closed-loop algorithm unit is also configured to generate a stop stimulation command and a stimulation electrode wearing check prompt signal when the stimulation parameters output by the percutaneous tibial nerve stimulation module reach the preset upper limit value and the first state signal and the second state signal do not reach the lower limit of their respective preset threshold ranges.

10. The closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface according to claim 1, characterized in that, The closed-loop percutaneous tibial nerve stimulation system also includes a mobile terminal, and the main control and closed-loop algorithm unit is further provided with a wireless communication module; the mobile terminal is used to communicate with the main control and closed-loop algorithm unit through the wireless communication module.

11. A control method for a closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface, applied to the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface as described in any one of claims 1 to 10, the control method comprising: During the process of applying stimulation pulses to the tibial nerve of the target's ankle through stimulation electrodes, a first state signal characterizing the activation state of the peripheral motor fibers of the tibial nerve is generated based on the acquired M-wave. A second state signal representing the activation state of the ascending sensory pathway is generated based on the collected somatosensory evoked potential P40. Based on the first state signal and the second state signal, a parameter adjustment command is generated according to a preset closed-loop control strategy, so that the percutaneous tibial nerve stimulation module dynamically adjusts the stimulation parameters in accordance with the parameter adjustment command.

12. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the computer program is executed, it implements the control method for the closed-loop percutaneous tibial nerve stimulation system based on a brain-computer interface as described in claim 11.

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