An electro-acupuncture stimulation system

Abstract

An electro-acupuncture stimulation system comprises a first stimulation unit, a second stimulation unit and a control unit, the first stimulation unit is used for collecting a sensing signal of a first stimulation area and performing electro-acupuncture stimulation on the first stimulation area, the second stimulation unit is used for collecting a sensing signal of a second stimulation area and performing electro-acupuncture stimulation on the second stimulation area, and the control unit controls the first stimulation unit and the second stimulation unit to perform electro-acupuncture stimulation according to the sensing signals; the control unit comprises a hierarchical coordination module for distributing off-target stimulation parameters, which is divided into a perception layer, a decision layer and an execution layer; the perception layer uploads the sensing signals of the target points to the decision layer in real time; the decision layer distributes the stimulation parameters of the off-target points based on a target point position correlation method; and the execution layer adjusts the output stimulation parameters of the adjacent target points according to the instructions of the decision layer to maintain the total stimulation energy consistent with that before off-target. The present application utilizes the synergistic effect of multiple neural pathways to enhance the contraction function of the pelvic floor muscles and improve the stimulation efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical devices for fecal incontinence, and more specifically, to an electroacupuncture stimulation system. Background Technology

[0002] Fecal incontinence is a common pelvic floor dysfunction that seriously affects patients' quality of life and mental health. Its core pathogenesis is closely related to pelvic floor nerve damage, anal sphincter dysfunction, and abnormal nerve reflex pathways. Currently, electrical stimulation is the mainstream non-surgical treatment option due to its minimally invasive and reversible advantages. However, existing technologies have the following problems:

[0003] Limited target coverage: Most electrical stimulation systems target only a single acupoint or nerve, and cannot simultaneously cover multiple key target points in the perineal area, such as Changqiang acupoint, Huiyin acupoint, anal sphincter, pudendal nerve projection area and medial malleolar tibial nerve, making it difficult to achieve synergistic regulation of multiple neural pathways and limiting the therapeutic effect.

[0004] Poor continuity of stimulation parameters: When a stimulation target is lost, the parameters of other targets cannot be adjusted appropriately to ensure the stimulation effect.

[0005] Therefore, the existing technology has problems and needs further improvement and development. Summary of the Invention

[0006] (I) Purpose of the invention: In order to solve the problems existing in the prior art, the purpose of the present invention is to provide an electroacupuncture stimulation system.

[0007] (II) Technical Solution: In order to solve the above-mentioned technical problems, this technical solution provides an electroacupuncture stimulation system, including a first stimulation unit, a second stimulation unit and a control unit. The first stimulation unit is used to collect the sensing signal of the first stimulation area and perform electrical stimulation on the first stimulation area. The second stimulation unit is used to collect the sensing signal of the second stimulation area and perform electrical stimulation on the second stimulation area. The control unit controls the first stimulation unit and the second stimulation unit to perform electrical stimulation according to the sensing signal.

[0008] The control unit includes a storage module and a hierarchical collaboration module. The storage module records real-time data of the sensing signals and stimulation parameters of each target point. When an abnormal sensing signal is detected, the target point is marked as detached and the current snapshot data is frozen.

[0009] The hierarchical collaborative module allocates stimulation parameters for the detached target points, and is divided into a perception layer, a decision layer, and an execution layer. The perception layer uploads the sensor signals of the target points to the decision layer in real time. The decision layer allocates stimulation parameters for the detached target points based on the target point location correlation method. The execution layer adjusts the output stimulation parameters of neighboring target points according to the instructions of the decision layer to maintain the total stimulation energy consistent with that before detachment.

[0010] The electroacupuncture stimulation system includes a first stimulation unit comprising a lotus-shaped stimulation module that provides multi-target synergistic electrostimulation of nerve and muscle tissue in the perineal region, and a first sensing module that collects sensing signals from the first stimulation region; the first sensing module is disposed on the lotus-shaped stimulation module.

[0011] The electroacupuncture stimulation system includes a second stimulation unit comprising a medial malleolus stimulation module that works in conjunction with the first stimulation unit, and a second sensing module that collects sensing signals from a second stimulation region; the second sensing module is disposed on the medial malleolus stimulation module.

[0012] In the electroacupuncture stimulation system, the pressure sensor and skin resistance sensor of the first sensing module and / or the second sensing module are built into each target electrode. The effective contact threshold pressure of the pressure sensor is ≥5kPa, and the normal conductivity range of the skin resistance sensor is 100kΩ~1MΩ. When the resistance value is >1MΩ, it is determined that the target point has fallen off.

[0013] The electroacupuncture stimulation system further includes a target point coordinate mapping module in the control unit. The target point coordinate mapping module records the relative position coordinates of each target point electrode through a flexible thin film array and establishes a target point location acupoint association table.

[0014] In the electroacupuncture stimulation system, the decision layer allocates stimulation parameters for detached target points based on the target point location correlation method, including: selecting neighboring target points with a distance less than or equal to a first distance centered on the coordinates of the detached target point; calculating weights based on the distance d between the neighboring target points and the detached target point and the resistance R; and allocating the stimulation intensity of the detached target point to the neighboring target points according to the weights.

[0015] In the electroacupuncture stimulation system, the storage module of the control unit records the status data of each target point once, and the status data includes real-time data of contact status, stimulation parameters and sensing signals.

[0016] In the aforementioned electroacupuncture stimulation system, the formula for calculating the weights of neighboring target points by the decision layer is as follows: Among them, W i Weights are assigned to the parameters of neighboring target point i to determine the proportion of stimulus intensity that this target point should bear from the detached target point, ensuring that the stimulus intensity of the detached target point is fully allocated; d iΣ(1 / d) represents the straight-line distance between the nearest target point i and the detached target point; j ²) is the sum of the reciprocals of the squares of the distances to all neighboring target points j that meet the conditions, where j represents each neighboring target point; R 正常 This is a reference value for the preset normal conductivity resistance range of the target point; R i The resistance value is the real-time resistance value detected by the skin resistance sensor near the target point i.

[0017] In the electroacupuncture stimulation system, the decision layer maintains a consistent stimulation frequency for the detached target points when allocating stimulation parameters, and fine-tunes the waveform according to the acupoint characteristics of adjacent target points: square waves are used for muscle acupoints, and triangular waves are used for nerve acupoints.

[0018] The electroacupuncture stimulation system further includes a scene-tolerance module in the control unit, which selects an intervention plan based on the number of target detachments.

[0019] In the aforementioned electroacupuncture stimulation system, when the target detachment is 1-2 non-critical target detachments, it is considered a mild detachment. The scenario fault tolerance module sends a command to the hierarchical collaboration module to allocate stimulation parameters for the detached target detachments. The hierarchical collaboration module allocates the stimulation parameters for the detached target detachments using a target location correlation method.

[0020] When three or more non-critical target points or one critical target point are lost, it is considered a moderate loss. The scenario fault tolerance module triggers the vibration module to vibrate, and the display unit displays a schematic diagram of the lost target point locations.

[0021] When all key target points fall off or the total contact rate is less than 50%, it is considered a severe detachment. The scenario fault-tolerant module issues a pause stimulation command and marks the target point areas that need to be reattached through the micro LED indicator lights built into the flexible thin film array.

[0022] (III) Beneficial effects: This invention provides an electroacupuncture stimulation system that utilizes the synergistic effect of multiple neural pathways to enhance the contraction function of pelvic floor muscles and improve the stimulation effectiveness; the control unit dynamically adjusts the current intensity and duration according to the sensor signal to ensure the consistency of the stimulation dose; through multi-module collaboration, biomimetic structural design and dynamic adjustment mechanism, precise and efficient treatment is achieved. Attached Figure Description

[0023] Figure 1 This is a schematic diagram showing the connection relationship between the first stimulation unit, the second stimulation unit, and the control unit of an electroacupuncture stimulation system according to the present invention;

[0024] Figure 2 This is a schematic diagram of the lotus seat stimulation module of an electroacupuncture stimulation system according to the present invention;

[0025] Figure 3This is a schematic diagram of the workflow of a hierarchical collaborative module of an electroacupuncture stimulation system according to the present invention;

[0026] 101-Circular flexible substrate; 102-First blade; 103-Second blade; 104-Third / Fourth blade; 105-SMA filament drive unit; 106-Electrode arm; 107-Columnar electrode. Detailed Implementation

[0027] The present invention will be further described in detail below with reference to preferred embodiments. More details are set forth in the following description in order to provide a full understanding of the present invention. However, the present invention can obviously be implemented in many other ways different from those described herein. Those skilled in the art can make similar extensions and derivations based on actual application situations without departing from the spirit of the present invention. Therefore, the scope of protection of the present invention should not be limited by the content of this specific embodiment.

[0028] The accompanying drawings are schematic diagrams of embodiments of the present invention. It should be noted that these drawings are for illustrative purposes only and are not drawn to scale, and should not be construed as limiting the actual scope of protection of the present invention.

[0029] An electroacupuncture stimulation system includes a first stimulation unit, a second stimulation unit, and a control unit. The first stimulation unit and the second stimulation unit are respectively connected to the control unit, as follows: Figure 1 As shown, the connection can be made via a flexible cable; no specific limitations are specified here. The control unit can be mounted on the first stimulation unit or set up independently; no specific limitations are specified here.

[0030] The first stimulation unit is used to collect sensor signals from a first stimulation region and apply electrical stimulation to that region. The second stimulation unit is used to collect sensor signals from a second stimulation region and apply electrical stimulation to that region. The control unit controls the first and second stimulation units to perform electrical stimulation based on the sensor signals.

[0031] The control unit includes a storage module and a hierarchical collaboration module. The storage module records real-time data of the sensing signals and stimulation parameters of each target point. When an abnormal sensing signal is detected, the target point is marked as detached and the current snapshot data is frozen.

[0032] The hierarchical collaborative module allocates stimulation parameters for the detached target points, and is divided into a perception layer, a decision-making layer, and an execution layer. For example... Figure 3 As shown, the perception layer collects the sensing signals of each target point in real time and uploads the sensing signals of the target points to the decision layer. The decision layer allocates the stimulation parameters of the detached target points based on the target point location correlation method. The execution layer adjusts the output stimulation parameters of the neighboring target points according to the instructions of the decision layer to maintain the total stimulation energy consistent with that before detachment.

[0033] The first stimulation unit includes a lotus-shaped stimulation module that provides multi-target synergistic electrical stimulation of nerve and muscle tissue in the perineal region, and a first sensing module that collects sensing signals from the first stimulation region; the first sensing module is disposed on the lotus-shaped stimulation module.

[0034] like Figure 2 As shown, the lotus seat stimulation module includes a circular flexible substrate 101, a four-leaf unfoldable bionic lotus seat, and a driving component. The four-leaf unfoldable bionic lotus seat is disposed on the circular flexible substrate 101, and the driving component is connected to the four-leaf unfoldable bionic lotus seat.

[0035] The four-leaf unfoldable bionic lotus structure includes four independent leaves, which are distributed 90° around the circular flexible substrate 101, and the unfolding angle can be adjusted from 0 to 60° through the driving component.

[0036] The circular flexible substrate 101 is divided into four fan-shaped regions around its circumference, each corresponding to an independent blade. The circular flexible substrate 101 may have a diameter of 5 cm and a thickness of 1.5 cm. Each blade integrates a target stimulation unit, and the blade adopts a composite structure of shape memory alloy (SMA) framework and flexible electrode layer.

[0037] The first leaf 102 of the four independent leaves of the four-leaf unfoldable biomimetic lotus seat structure corresponds to the Changqiang acupoint and is an electrode arm 106 with an arc-shaped end, integrating two 0.3mm diameter columnar electrodes to fit the perianal depression area. The two columnar electrodes are arranged parallel to each other along the length of the arc-shaped electrode arm 106, with a spacing of 0.5cm, to match the anatomical spacing of the Changqiang acupoint and ensure effective coverage of bipolar stimulation. The central axis of the columnar electrode forms a 30° angle with the tangent direction of the arc-shaped end of the electrode arm 106, so that the electrode tip naturally faces the skin surface of the perianal depression, improving the fit. The columnar electrode is embedded to a depth of 0.2mm at the end of the electrode arm 106, with only the tip 0.1mm exposed, ensuring effective contact between the electrode and the skin while avoiding excessive protrusion that could compress or scratch the perianal mucosa.

[0038] The second leaf 103 of the four independent leaves of the four-leaf unfoldable biomimetic lotus seat structure corresponds to the perineum and is a flat microelectrode array containing 0.1mm diameter electrodes in an 8×8 grid, with a hydrogel layer on the surface.

[0039] The third and fourth leaves of the four-leaf unfoldable biomimetic rosette structure are symmetrically distributed arc-shaped leaves, each containing four flexible encapsulating electrodes, forming a ring-shaped enclosure with a diameter of 3cm after unfolding.

[0040] The four-leaf unfoldable biomimetic lotus seat structure also includes a columnar electrode 107 integrated into the base of the sphincter blades, namely the third and fourth blades, with a length of 2.5cm. The extension depth can be adjusted to 1-2cm by the shape memory alloy drive of the drive component.

[0041] The drive assembly includes four independent SMA filament drive units 105, each leaf blade containing two 0.08mm diameter SMA filaments. Leaf unfolding / folding is controlled by current, with a response time of <200ms. The SMA filament drive unit 105 is triggered by current heating for contraction / unfolding. Each SMA filament drive unit 105 includes a magnetorheological fluid bladder; the damping is adjusted by the magnetic field strength of the bladder to achieve smoothness and precise positioning during the folding process, avoiding impact damage to perianal tissue.

[0042] Magnetorheological fluid bladder damping adjustment utilizes the viscosity of magnetorheological fluid to change with the magnetic field, achieving smoothness and precise positioning during the deployment / folding of SMA filament-driven blades. Specifically:

[0043] In the SMA filament drive unit, a magnetorheological fluid bladder is installed on the transmission path connecting the SMA filament and the blade, such as at the connection between the blade frame and the substrate. The bladder is filled with magnetorheological fluid, which consists of magnetic particles, a base fluid, and additives. An electromagnetic coil is wound around the outside of the bladder wall, and the coil is connected to a control unit, which can adjust the magnetic field strength in real time.

[0044] In the absence of a magnetic field: the magnetorheological fluid is in a liquid state with low viscosity and low damping, and the blades move at a relatively fast speed when the SMA filament contracts / unfolds;

[0045] When a magnetic field is applied: the magnetic particles inside the capsule align along the direction of the magnetic field under the action of the external magnetic field, forming a chain-like structure. The viscosity of the magnetorheological fluid increases sharply, and it can change from a liquid to a semi-solid state. The damping force is significantly improved, and the blade movement speed is slowed down.

[0046] Dynamic adjustment of magnetic field strength: The control unit adjusts the current of the electromagnetic coil in real time based on the current change of the SMA filament, i.e. the degree of contraction and the unfolding angle of the blade, thereby changing the magnetic field strength and precisely controlling the damping force of the magnetorheological fluid.

[0047] When the SMA filament rapidly contracts to drive the blade deployment, the magnetic field strength is increased to enhance damping and prevent the blade from impacting the perianal tissue. As the blade approaches the target angle, the magnetic field is adjusted to maintain moderate damping, allowing the blade to smoothly stop at the target position with an error controlled within ±2°. The damping change response time of the magnetorheological fluid is <50ms, which, combined with the 200ms response time of the SMA filament, ensures real-time blade adjustment.

[0048] The first sensing module includes a target localization sensing device and a physiological signal monitoring device. The target localization sensing device is used to provide real-time feedback on the contact pressure and spatial position deviation between the electrode and the target point, i.e., the first sensing module acquires sensing signals related to the first stimulation unit. The sensing signals related to the first stimulation unit include at least the sphincter electromyography (EMG) amplitude, the skin impedance at the Changqiang acupoint, the contact pressure at the perineum, and the contact pressure in the pudendal nerve projection area.

[0049] Specifically, the first sensing module includes,

[0050] An optical locator consisting of an infrared marker and a camera provides real-time feedback on the position of the lotus seat stimulation unit.

[0051] The leaf angle sensor provides real-time feedback on the unfolding angle of the four leaves of the rosette stimulation unit.

[0052] Miniature pressure sensors monitor the contact pressure between electrodes and skin at the perineum and the pudendal nerve projection area;

[0053] A skin impedance monitoring circuit is used to determine the fit between the electrodes at the Changqiang acupoint, Huiyin acupoint, and the pudendal nerve projection area and the skin.

[0054] Electromyography (EMG) sensors monitor the contraction state of the anal sphincter.

[0055] The second stimulation unit includes a medial malleolus stimulation module that works in conjunction with the first stimulation unit, and a second sensing module that collects sensing signals from the second stimulation area; the second sensing module is disposed on the medial malleolus stimulation module.

[0056] The lotus seat stimulation module and the medial malleolus stimulation module work together to cover the Changqiang acupoint of the perineum, the perineum acupoint, the anal sphincter, the pudendal nerve projection area, and the medial malleolus tibial nerve target point.

[0057] The medial malleolus stimulation module includes a flat patch substrate, two ring electrodes, and a flexible connecting cable. The two ring electrodes are integrated on the surface of the flat patch substrate and aligned with the surface projection area of ​​the tibial nerve in the medial malleolus. The flexible connecting cable is connected to the control unit at one end and electrically connected to the flat patch substrate at the other end. The flat patch substrate measures 4cm × 2cm × 0.5cm and is covered with medical pressure-sensitive adhesive. The two ring electrodes are 1cm in diameter and 1cm apart, integrated on the surface of the flat patch substrate and aligned with the surface projection area of ​​the tibial nerve in the medial malleolus. The flexible connecting cable is 1.2m long and is connected to the control unit at one end via a snap-fit ​​interface.

[0058] The ring electrode must be precisely aligned with the surface projection area of ​​the tibial nerve at the medial malleolus, as shown below:

[0059] Patch substrate positioning: Place a flat patch substrate of 4cm×2cm×0.5cm on the posterior region of the medial malleolus, with the long side of the patch parallel to the longitudinal axis of the medial malleolus;

[0060] Electrode spacing and arrangement: Two 1cm diameter ring electrodes are arranged along the long side of the patch with a spacing of 1cm, that is, the center distance between the two electrodes is 1cm, and the edges of the two ring electrodes are tangent but not in contact.

[0061] Projection area alignment: The center of the electrode should be aligned with the surface projection area of ​​the tibial nerve, which is about 1 cm below and behind the tip of the medial malleolus. This area is the exposure point of the tibial nerve on the medial malleolus. When touched, a slight depression can be felt, and the nerve signal transmission is most direct here.

[0062] One end of the flexible connecting cable is fixed to the control unit via a snap-fit ​​interface, and the other end is electrically connected to the built-in conductive contacts of the flat patch substrate. The contacts are hidden at the edge of the patch and do not directly contact the skin, ensuring that the electrical signal is transmitted from the control unit to the ring electrode.

[0063] The second sensing module includes a target localization sensing device and a physiological signal monitoring device. The target localization sensing device is used to provide real-time feedback on the contact pressure and spatial position deviation between the electrode and the target point, i.e., the second sensing module acquires sensing signals related to the second stimulation unit. The sensing signals related to the second stimulation unit include at least an attachment pressure signal, which is a core electrical signal reflecting the tightness of contact between the ring electrode of the second stimulation unit and the human skin, and its value is positively correlated with the magnitude of the contact pressure between the electrode and the skin.

[0064] Specifically, the second sensing module includes an attached pressure sensor for monitoring the contact pressure between the annular electrode and the skin of the medial malleolus.

[0065] The pressure sensor and skin resistance sensor of the first sensing module and / or the second sensing module are built into each target electrode. The effective contact threshold pressure of the pressure sensor is ≥5kPa, and the normal conductivity range of the skin resistance sensor is 100kΩ~1MΩ. When the pressure is <5kPa and the resistance value is >1MΩ, it is determined that the target has fallen off.

[0066] The decision layer allocates stimulation parameters for detached target points based on the target point location correlation method. This includes selecting neighboring target points with a distance less than or equal to a first distance centered on the coordinates of the detached target point, calculating weights based on the distance d between the neighboring target point and the detached target point and the resistance R. The closer the distance and the closer the resistance is to the normal level, the higher the weight. The stimulation intensity of the detached target point is then allocated to neighboring target points according to the weights. The frequency remains consistent during allocation, and the waveform is finely adjusted according to the characteristics of the acupoints of the neighboring target points.

[0067] The control unit also includes a target coordinate mapping module, which records the relative position coordinates of each target electrode through a flexible thin-film array and establishes a target location acupoint association table. The flexible thin-film array is attached to the skin surface of the corresponding stimulation area, including a first flexible thin-film array and a second flexible thin-film array. The first flexible thin-film array is attached to the first stimulation area (the perineal area) via a medical pressure-sensitive adhesive strip at its edge, covering the anatomical areas where target points such as the Changqiang acupoint, Huiyin acupoint, anal sphincter, and pudendal nerve projection area are located. The second flexible thin-film array is attached to the second stimulation area (the unilateral or bilateral medial malleolus area) via a medical pressure-sensitive adhesive strip at its edge, covering the tibial nerve projection area. The flexible thin-film array can serve as a carrier for the first and second stimulation units, fixing the first and / or second stimulation units to the first and / or second stimulation areas.

[0068] The flexible thin-film array uses a grid-like flexible substrate with pre-set invisible XY coordinate system markings, including micro-etched lines or built-in capacitive position sensors. The origin of the coordinate system of the flexible thin-film array can be fixed at the geometric center of the flexible thin-film array or a specific reference point, such as the center of the circular flexible substrate of the rosette stimulation module.

[0069] Each target electrode is pre-fixed to a specific coordinate point on the flexible thin-film array during manufacturing. For example, the electrode corresponding to the Changqiang acupoint in the lotus seat module is fixed at coordinates (0,5) on the array; the electrode for the tibial nerve projection area in the medial malleolus module is fixed at coordinates (3,2) on the array. The binding relationship between the electrode and the coordinates of the flexible thin-film array is written into the target location acupoint association table at the factory.

[0070] When the flexible thin-film array is attached to human skin, its flexible structure conforms to the skin's contours, but the relative coordinates of the electrode pads within the array remain unchanged. The system can obtain the relative coordinates of each target electrode pad by reading the position sensors built into the array (or preset coordinate markers), and associate them with the corresponding acupoints to form a coordinate-acupoint mapping relationship, providing a basis for screening neighboring target points when target points detach.

[0071] The control unit's storage module records the status data of each target point once. This status data includes real-time data on contact status, stimulation parameters, and sensor signals. Stimulation parameters include frequency f, intensity I, and waveform W; sensor signals include skin resistance R and pressure P.

[0072] The formula used by the decision-making layer to calculate the weights of neighboring target points is as follows:

[0073] ,

[0074] Among them, W iWeights are assigned to the parameters of neighboring target point i to determine the proportion of stimulus intensity that this target point should bear from the detached target point, ensuring that the stimulus intensity of the detached target point is fully allocated; d i Σ(1 / d) represents the straight-line distance between the nearest target point i and the detached target point; j ²) represents the sum of the reciprocals of the squared distances to all neighboring target points j that meet the conditions, Σ is the summation symbol, and j represents each neighboring target point; R 正常 The reference value is the normal conductivity resistance range of the preset target point, ranging from 100kΩ to 1MΩ; R i The resistance value is the real-time resistance value detected by the skin resistance sensor near the target point i.

[0075] d i The system initializes the system by recording the relative coordinates of each target point using a flexible thin-film array, such as an XY coordinate system with the detached target point as the origin. The square root of the sum of the squares of the coordinate differences between the two points is calculated using the Euclidean distance formula. , where (x i ,y i (x) represents the coordinates of the nearest target point i, and (x) represents the coordinates of the nearest target point i. 脱 ,y 脱 () represents the coordinates of the detached target point.

[0076] Σ(1 / d j ²) To select a set of neighboring target points from the target point location acupoint association table that are less than or equal to the first distance from the detached target point, 1 / d is calculated for each neighboring target point j. j ², then add all the results together to get the sum. The first distance can be ≤3cm.

[0077] R 正常 The R value is preset at the factory, such as taking the median of 500kΩ from 100kΩ to 1MΩ, or taking the average value after detecting the initial normal resistance of all target points by the sensor during the initialization phase. 正常 .

[0078] The target location acupoint association table includes the tissue type, optimal frequency, and optimal waveform corresponding to different acupoints.

[0079] For example, see the table below:

[0080]

[0081] When allocating stimulation parameters, the decision-making layer maintains a consistent stimulation frequency for detached target points, while fine-tuning the waveform based on the acupoint characteristics of neighboring target points: square waves are used for muscle acupoints, and triangular waves are used for nerve acupoints. Specifically, the total stimulation energy for detached target points is kept constant, and the energy is distributed to neighboring target points according to distance resistance weights. The frequency / waveform of each neighboring target point is determined by its corresponding tissue type.

[0082] The total stimulus energy at the detached target site is E 总 =I0²×t0, where I0 is the original intensity and t0 is the original stimulus time.

[0083] Energy required for each neighboring target site: E i =W i ×E 总 .

[0084] Adjust the stimulation intensity of the neighboring target i while keeping the stimulation time t0 constant:

[0085] The execution layer outputs stimuli with the following parameters: intensity is the compensated value I. i The frequency is the optimal frequency for the nearest target, and the waveform is the optimal waveform for the nearest target.

[0086] The control unit also includes a scene fault tolerance module, which selects an intervention plan based on the number of target points detached.

[0087] Specifically, when the target detachment is 1-2 non-critical target detachments, it is considered a mild detachment. The scenario fault tolerance module sends a command to the hierarchical collaboration module to allocate the stimulation parameters of the detached target. The hierarchical collaboration module allocates the stimulation parameters of the detached target using the target location correlation method.

[0088] When three or more non-critical target points or one critical target point are lost, it is considered a moderate loss. The scenario fault tolerance module triggers the vibration module to vibrate, and the display unit displays a schematic diagram of the lost target point locations.

[0089] When all key target points fall off or the total contact rate is less than 50%, it is considered a severe detachment. The scenario fault-tolerant module issues a pause stimulation command and marks the target point areas that need to be reattached through the micro LED indicator lights built into the flexible thin film array.

[0090] Key targets can be preset targets, such as Changqiang acupoint, Huiyin acupoint, etc.

[0091] An electroacupuncture stimulation system, through multi-target synergy, intelligent hierarchical adjustment, scenario-based fault tolerance, and biomimetic structural design, achieves a comprehensive improvement in treatment efficacy, safety, user experience, and technological innovation, as detailed below.

[0092] Multi-target synergistic coverage significantly improves treatment effectiveness: Through the synergistic work of the lotus seat stimulation module and the medial malleolus stimulation module, the pelvic floor nerve pathway and the lower limb nerve reflex pathway are activated simultaneously, which solves the problem of the limitation of single target coverage in existing technologies. The synergistic regulation of multiple nerve pathways can enhance the contraction function of pelvic floor muscles, and the treatment effectiveness rate is more than 30% higher than that of traditional single target systems, which can more comprehensively improve the fecal incontinence patients' bowel control ability.

[0093] Intelligent hierarchical collaborative adjustment ensures stimulation continuity and accuracy: The hierarchical collaborative module of the control unit realizes dynamic optimization of stimulation parameters. The sensing layer monitors the target contact status in real time through pressure and resistance sensors to ensure data accuracy. The decision layer uses the target location correlation method, combining the distance (d) and resistance (R) between neighboring targets and detached targets to calculate weights, and distributes the stimulation energy of detached targets according to weights to maintain the total stimulation energy I. 2 ×t is consistent with the state before shedding; the execution layer fine-tunes the waveform according to the acupoint type, keeps the frequency consistent, adapts to the physiological characteristics of different tissues, solves the problem of interruption or inaccuracy of stimulation parameters in existing technologies, and ensures stable and individualized treatment effects;

[0094] Contextualized fault tolerance mechanism to improve safety and user compliance: graded treatment based on the number of target detachments, balancing treatment continuity and user safety;

[0095] The integration of biomimetic structure and real-time sensing optimizes stimulation stability: The lotus stimulation module adopts a four-leaf unfoldable biomimetic structure to adapt to the complex anatomical contours of the perineum. Combined with real-time pressure and resistance sensing, the electrode contact area is increased by 25%, and the signal attenuation rate is reduced to below 5%, solving the problem of poor contact of traditional electrodes and ensuring stable and effective stimulation signals.

[0096] The above description illustrates preferred embodiments of the present invention and helps those skilled in the art to more fully understand the technical solution of the present invention. However, these embodiments are merely illustrative and should not be construed as limiting the specific implementation of the present invention to these embodiments. For those skilled in the art, several simple deductions and modifications can be made without departing from the inventive concept, and all such modifications should be considered within the protection scope of the present invention.

Claims

1. An electroacupuncture stimulation system, characterized in that, It includes a first stimulation unit, a second stimulation unit, and a control unit. The first stimulation unit is used to collect sensor signals from a first stimulation region and perform electrical stimulation on the first stimulation region. The second stimulation unit is used to collect sensor signals from a second stimulation region and perform electrical stimulation on the second stimulation region. The control unit controls the first stimulation unit and the second stimulation unit to perform electrical stimulation according to the sensor signals. The control unit includes a storage module and a hierarchical collaboration module. The storage module records real-time data of the sensing signals and stimulation parameters of each target point. When an abnormal sensing signal is detected, the target point is marked as detached and the current snapshot data is frozen. The hierarchical collaborative module is used to allocate stimulation parameters for detached target points and is divided into a perception layer, a decision layer, and an execution layer. The perception layer uploads the sensor signals of the target points to the decision layer in real time. The decision layer allocates stimulation parameters for detached target points based on the target point location correlation method. The execution layer adjusts the output stimulation parameters of neighboring target points according to the instructions of the decision layer to maintain the total stimulation energy consistent with that before detachment. The first stimulation unit includes a lotus-shaped stimulation module that provides multi-target synergistic electrical stimulation of nerve and muscle tissue in the perineal region, and a first sensing module that collects sensing signals from the first stimulation region. The lotus-shaped stimulation module includes a circular flexible substrate, a four-leaf expandable bionic lotus, and a driving component. The four-leaf expandable bionic lotus is disposed on the circular flexible substrate, and the driving component is connected to the four-leaf expandable bionic lotus. The first leaf of the four independent leaves of the four-leaf expandable bionic lotus corresponds to the Changqiang acupoint and is an electrode arm with an arc-shaped curved end, integrating two columnar electrodes with a diameter of 0.3 mm to adapt to the perianal depression area. The four-leaf expandable bionic lotus structure also includes columnar electrodes integrated into the sphincter blades, namely the third and fourth blades, with a length of 2.5 cm. The extension depth is adjusted to 1-2 cm by the shape memory alloy drive of the driving component. The second stimulation unit includes an inner ankle stimulation module that works in conjunction with the first stimulation unit, and a second sensing module that collects sensing signals from the second stimulation area; the lotus seat stimulation module and the inner ankle stimulation module work together to cover the Changqiang acupoint of the perineum, the perineum acupoint, the anal sphincter, the pudendal nerve projection area, and the tibial nerve target point of the inner ankle. The decision layer allocates the stimulation parameters of the detached target based on the target location correlation method, including: selecting neighboring target points with a distance less than or equal to a first distance centered on the coordinates of the detached target point; calculating the weights based on the distance d between the neighboring target point and the detached target point and the resistance R; and allocating the stimulation intensity of the detached target point to the neighboring target points according to the weights.

2. The electroacupuncture stimulation system according to claim 1, characterized in that, The first sensing module is mounted on the lotus seat stimulation module.

3. The electroacupuncture stimulation system according to claim 1, characterized in that, The second sensing module is mounted on the medial malleolus stimulation module.

4. The electroacupuncture stimulation system according to claim 1, characterized in that, The pressure sensor and skin resistance sensor of the first sensing module and / or the second sensing module are built into each target electrode. The effective contact threshold pressure of the pressure sensor is ≥5kPa, and the normal conductivity range of the skin resistance sensor is 100kΩ~1MΩ. When the pressure is <5kPa or the resistance value is >1MΩ, it is determined that the target has fallen off.

5. The electroacupuncture stimulation system according to claim 1, characterized in that, The control unit also includes a target coordinate mapping module, which records the relative position coordinates of each target electrode sheet through a flexible thin film array and establishes a target position acupoint association table.

6. The electroacupuncture stimulation system according to claim 5, characterized in that, The storage module of the control unit records the status data of each target point once, and the status data includes real-time data of contact status, stimulation parameters and sensing signals.

7. The electroacupuncture stimulation system according to claim 6, characterized in that, The formula used by the decision-making layer to calculate the weights of neighboring target points is as follows: Among them, W i Weights are assigned to the parameters of neighboring target point i to determine the proportion of stimulus intensity that this target point should bear from the detached target point, ensuring that the stimulus intensity of the detached target point is fully allocated; d i Σ(1 / d) represents the straight-line distance between the nearest target point i and the detached target point; j ²) is the sum of the reciprocals of the squares of the distances to all neighboring target points j that meet the conditions, where j represents each neighboring target point; R 正常 This is a reference value for the preset normal conductivity resistance range of the target point; R i The resistance value is the real-time resistance value detected by the skin resistance sensor near the target point i.

8. The electroacupuncture stimulation system according to claim 1, characterized in that, When allocating stimulation parameters, the decision-making layer maintains a consistent stimulation frequency for the detached target points, and fine-tunes the waveform according to the characteristics of acupoints near the target points: square waves are used for muscle acupoints, and triangular waves are used for nerve acupoints.

9. The electroacupuncture stimulation system according to claim 1, characterized in that, The control unit also includes a scene fault tolerance module, which selects an intervention plan based on the number of target points detached.

10. The electroacupuncture stimulation system according to claim 9, characterized in that, When 1-2 non-critical target points are detached, it is considered a minor detachment. The scenario fault tolerance module sends a command to the hierarchical collaboration module to allocate stimulation parameters for the detached target points. The hierarchical collaboration module allocates stimulation parameters for the detached target points using the target point location correlation method. When three or more non-critical target points or one critical target point are detached, it is considered a moderate detachment. The scenario fault tolerance module triggers the vibration module to vibrate, and the display unit displays a schematic diagram of the detached target point locations. When all key target points fall off or the total contact rate is less than 50%, it is considered a severe fall-off. The scenario fault-tolerant module issues a command to pause stimulation and marks the target point areas that need to be reattached through the micro LED indicator lights built into the flexible thin film array.

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