Coupling quality evaluation and dose compensation method and system for combined acoustic-electric therapy

CN122874802APending Publication Date: 2026-10-09XIAN NEW HOPE MEDICAL EQUIP CO LTD
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Patent Information

Application Number
CN202611285431.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-08-24
Publication Date
2026-10-09

AI Technical Summary

Technical Problem

此时,如果仅依据单一温升结果、单一阻抗结果或者单次诱发响应结果进行判断,一方面难以区分异常来源究竟来自声学耦合衰减还是电接触漂移,另一方面也难以判断当前治疗剂量变化是否已经影响到目标组织的实际生理响应,容易出现补偿调整针对性不足、继续治疗条件判断不准确,甚至在界面状态已经失配时仍维持原治疗输出的情况

Benefits of technology

[0053]本申请首先通过在治疗前采集得到参考耦合状态,并在治疗过程中连续采集得到多源耦合观测数据,再依据参考耦合状态与多源耦合观测数据计算声学耦合衰减指数、电接触漂移指数和联合耦合质量分数,将现有技术中相互分散的超声治疗界面监测、生物电刺激接触监测和诱发响应评估过程组织为统一的生物医学工程处理链条;由此能够将声学传递界面状态、电刺激接触状态和目标组织诱发响应状态进行对应分析,减少仅依据单一温度结果、单一阻抗结果或者单一响应结果进行判断所造成的误判问题,提高声电联合治疗过程中耦合质量评估的准确性和一致性。

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Abstract

The application relates to the technical field of biomedical engineering, and discloses a coupling quality evaluation and dose compensation method and system for acoustic-electric combined treatment; a reference coupling state is collected before treatment, multi-source coupling observation data are continuously collected during treatment, an acoustic coupling attenuation index and an electric contact drift index are calculated according to the reference coupling state and the multi-source coupling observation data, and a combined coupling quality score is calculated; when the combined coupling quality score decreases relative to the combined coupling quality score corresponding to the previous collection time and the induced response change is lower than the initial induced response, limited compensation is executed according to the reference coupling state; when the induced response change still indicates that the current response result is lower than the initial induced response after the limited compensation is executed, it is determined that a mismatch state occurs and the treatment is terminated or degraded; the application can improve the coupling state evaluation accuracy, dose compensation pertinence and treatment safety in the acoustic-electric combined treatment process.
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Description

Technical Field

[0001] This application relates to the field of biomedical engineering technology, specifically to a method and system for coupling quality assessment and dose compensation for combined acoustic and electrical therapy. Background Technology

[0002] With the development of biomedical engineering, rehabilitation engineering, and medical treatment devices, the combined application of ultrasound therapy and electrical stimulation therapy is increasingly being used in neuromuscular rehabilitation, pain relief, tissue stimulation, and functional reconstruction. These treatment devices typically deliver ultrasound energy to human tissue via a treatment probe and electrical stimulation pulses to the target tissue via electrodes, aiming to achieve better therapeutic effects in a single treatment session. To ensure effectiveness, it is necessary to maintain not only the acoustic coupling between the probe and the skin but also the electrical contact between the electrodes and the skin during treatment, keeping the ultrasound energy transmission path and the electrical stimulation transmission path relatively stable.

[0003] In existing technologies, most approaches to controlling the combined acoustic and electrical stimulation (AES) therapy process still rely on single-channel parameters for judgment. For example, some approaches primarily detect electrode contact impedance, electromyographic response, or local movement to determine the effectiveness of electrical stimulation; others focus on the state of the coupling medium, interface temperature rise, ultrasound reflection echo, or probe adhesion to determine whether ultrasound therapy should continue. While these methods can provide indications of local abnormalities, they typically treat the ultrasound side and the electrical stimulation side separately, lacking a coordinated assessment across the entire treatment process.

[0004] In actual clinical applications or rehabilitation training, changes in the subject's body surface deformation, slight limb movements, sweating, changes in the distribution of coupling medium, electrode edge lifting, and changes in the pressure of the treatment probe can all lead to dynamic changes in the acoustic transmission conditions between the probe and the skin, as well as the conductivity conditions between the electrode and the skin. In such cases, relying solely on a single temperature rise result, a single impedance result, or a single induced response result makes it difficult to distinguish whether the abnormality originates from acoustic coupling attenuation or electrical contact drift. Furthermore, it makes it difficult to determine whether the current change in treatment dosage has already affected the actual physiological response of the target tissue. This can easily lead to insufficient targeted compensation adjustments, inaccurate judgment of continued treatment conditions, or even maintaining the original treatment output when the interface state has already become mismatched.

[0005] Therefore, the existing technology still has the following shortcomings: In the biomedical engineering scenario of combined acoustic and electrical therapy, there is still a lack of a processing method that can make a unified judgment on the relationship between the ultrasound treatment channel, the electrical stimulation treatment channel and the target tissue induced response, so as to more accurately identify the impact of the coupling state change on the treatment dose and treatment safety during the treatment process. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this application aims to provide a method and system for coupling quality assessment and dose compensation in combined acoustic and electrical therapy. By jointly acquiring, assessing, and controlling the tissue interface state, contact transmission state, and induced response results of the ultrasound therapy channel and the bioelectric stimulation channel in a biomedical engineering treatment setting, this method solves the problems of dispersed judgment of acoustic coupling state and electrical contact state, difficulty in accurately representing the effective therapeutic dose, insufficient basis for dose compensation, and difficulty in balancing treatment safety and efficacy in existing technologies. This achieves the technical effects of accurately assessing the coupling quality during combined acoustic and electrical therapy, providing limited compensation for the therapeutic dose, and timely terminating or downgrading the treatment in cases of mismatch.

[0007] To achieve the above objectives, this application adopts the following technical solution:

[0008] Firstly, this application provides a method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy, including:

[0009] A reference coupling state was obtained before treatment;

[0010] Multi-source coupled observation data were continuously collected during the treatment process;

[0011] The acoustic coupling attenuation index and electrical contact drift index are calculated based on the reference coupling state and multi-source coupling observation data; the joint coupling quality fraction is calculated based on the acoustic coupling attenuation index and electrical contact drift index.

[0012] When the joint coupling quality score decreases relative to the joint coupling quality score at the previous acquisition time, and the changes in the induced response in the multi-source coupled observation data indicate that the current response result is lower than the initial induced response in the reference coupling state, limited compensation is performed based on the reference coupling state.

[0013] If, after implementing limited compensation, the induced response change still indicates that the current response result is lower than the initial induced response, it is determined to be a mismatch state and treatment is terminated or downgraded.

[0014] Preferably, the method for calculating the acoustic coupling attenuation index includes:

[0015] Read the initial ultrasonic reflection echo characteristics, initial interface temperature rise, and initial coupling layer thickness in the reference coupling state;

[0016] Read the ultrasonic reflection echo characteristics, interface temperature rise, and coupling layer thickness difference from the multi-source coupled observation data, and determine the reflection deviation, temperature rise deviation, and thickness deviation results, respectively.

[0017] The acoustic coupling attenuation index is calculated based on the reflection deviation, temperature rise deviation, and thickness deviation results, thereby quantitatively evaluating the tissue interface transmission state in the ultrasound treatment channel.

[0018] Preferably, the method for calculating the electrical contact drift index includes:

[0019] Read the initial electrode contact impedance and initial local motion state in the reference coupling state;

[0020] Read the changes in electrode contact impedance, local motion state, and induced response from the multi-source coupled observation data, and determine the impedance deviation, motion deviation, and response deviation results, respectively.

[0021] The electrical contact drift index is calculated based on the impedance deviation, motion deviation, and response deviation results, thereby quantitatively assessing the contact transmission state in the bioelectric stimulation channel.

[0022] Preferably, the method for calculating the joint coupling quality score includes:

[0023] Acoustic component quality values ​​are generated based on the acoustic coupling attenuation index;

[0024] The electrical contact sub-quality values ​​are generated based on the electrical contact drift index;

[0025] The acoustic sub-quality values ​​and the electrical contact sub-quality values ​​are compared on the same score scale, and the sub-quality value with the smaller value is determined as the base quality value.

[0026] The baseline quality value is corrected by combining the deviation of the induced response from the initial induced response to obtain the joint coupling quality score, thereby unifying the tissue interface state, contact state and target tissue response state into the same evaluation result.

[0027] Preferably, the method for performing limited compensation includes:

[0028] Read the initial output parameters in the reference coupling state, and generate compensation and adjustment results based on the acoustic coupling attenuation index and the electrical contact drift index;

[0029] Limited compensation is performed based on the initial output parameters and the compensation adjustment results.

[0030] Preferably, the method for performing limited compensation further includes:

[0031] Before performing limited compensation based on the initial output parameters and compensation adjustment results, a contact recovery command is generated based on the multi-source coupled observation data. After the contact recovery command is output, the multi-source coupled observation data is reacquired.

[0032] If the changes in the induced response obtained from the re-acquisition still indicate that the current response result is lower than the initial induced response, then limited compensation is performed based on the initial output parameters and the compensation adjustment results.

[0033] Preferably, the method for generating a contact recovery command includes:

[0034] When the difference in coupling layer thickness exceeds the natural fluctuation range corresponding to the difference in coupling layer thickness, and the interface temperature rise is not higher than the initial interface temperature rise, a coupling medium replenishment command is generated.

[0035] When the difference in coupling layer thickness exceeds the natural fluctuation range corresponding to the difference in coupling layer thickness, and the interface temperature rises above the initial interface temperature rise, a probe clamping correction command is generated.

[0036] When the electrode contact impedance exceeds the natural fluctuation range corresponding to the initial electrode contact impedance, an electrode reattachment command is generated.

[0037] When the maximum value of the current displacement change in the local motion state exceeds the natural fluctuation range corresponding to the maximum displacement change, or when the maximum value of the current attitude change exceeds the natural fluctuation range corresponding to the maximum attitude change, a strap pressure adjustment command is generated.

[0038] Contact restoration commands include coupling medium replenishment commands, probe clamping correction commands, electrode reattachment commands, and strap pressure adjustment commands.

[0039] Preferably, the method for determining a mismatch state includes:

[0040] After performing the restricted compensation, the joint coupling quality score is recalculated;

[0041] When the recalculated joint coupling quality score decreases compared to the most recently calculated joint coupling quality score before the execution of constrained compensation, and the changes in the induced response at at least two adjacent acquisition times indicate that the current response result is lower than the initial induced response, it is determined to be a mismatch state.

[0042] Preferably, terminating or downgrading treatment specifically means:

[0043] When the interface temperature rise in the multi-source coupled observation data corresponding to the mismatch state exceeds the initial interface temperature rise in the reference coupled state, a treatment termination command is output.

[0044] When the interface temperature rise in the multi-source coupling observation data corresponding to the mismatch state is not higher than the initial interface temperature rise in the reference coupling state, a downgrade treatment command is output, and treatment continues according to the downgrade output parameters. The downgrade output parameters include ultrasound intensity, duty cycle, current, and pulse width that are lower than the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width, respectively.

[0045] Preferably, when the interface temperature rise in the multi-source coupled observation data is higher than the initial interface temperature rise in the reference coupling state, the ultrasonic intensity adjustment result and duty cycle adjustment result in the compensation adjustment result shall not read the ultrasonic intensity compensation level and duty cycle compensation level that are arranged after the current corresponding compensation level in the preset compensation level order.

[0046] Secondly, this application provides a coupling quality assessment and dose compensation system for combined acoustic and electrical therapy, including:

[0047] The first acquisition module is used to acquire a reference coupling state before treatment.

[0048] The second acquisition module is used to continuously acquire multi-source coupled observation data during the treatment process;

[0049] The index calculation module is used to calculate the acoustic coupling attenuation index and the electrical contact drift index based on the reference coupling state and multi-source coupling observation data; and to calculate the joint coupling quality fraction based on the acoustic coupling attenuation index and the electrical contact drift index.

[0050] The compensation execution module is used to perform limited compensation based on the reference coupling state when the joint coupling quality score decreases relative to the joint coupling quality score at the previous acquisition time, and the changes in the induced response in the multi-source coupled observation data indicate that the current response result is lower than the initial induced response in the reference coupling state.

[0051] The status determination module is used to determine a mismatch state and terminate or downgrade treatment when the induced response change after limited compensation still indicates that the current response result is lower than the initial induced response.

[0052] Compared with the prior art, the beneficial effects achieved by this application are as follows:

[0053] This application first obtains a reference coupling state before treatment and continuously collects multi-source coupling observation data during treatment. Then, based on the reference coupling state and multi-source coupling observation data, it calculates the acoustic coupling attenuation index, electrical contact drift index, and joint coupling quality score. This organizes the previously dispersed processes of ultrasound treatment interface monitoring, bioelectric stimulation contact monitoring, and induced response assessment into a unified biomedical engineering processing chain. As a result, the acoustic transmission interface state, electrical stimulation contact state, and target tissue induced response state can be analyzed in a corresponding manner, reducing the misjudgment caused by relying solely on a single temperature result, a single impedance result, or a single response result, and improving the accuracy and consistency of coupling quality assessment during combined acoustic and electrical therapy.

[0054] This application further demonstrates that when the joint coupling quality score decreases relative to the previous acquisition time, and the evoked response change indicates that the current response result is lower than the initial evoked response, constrained compensation is performed based on the reference coupling state. This allows the initial output parameters that have already formed an effective therapeutic effect under the reference coupling state to serve as the basis for subsequent dose compensation. As a result, the ultrasound output and bioelectric stimulation output in combined acoustic and electrical therapy are no longer adjusted independently of the tissue interface state and the evoked response result, but rather constrained dose compensation is performed based on the current degree of coupling deviation, thereby improving the specificity of treatment dose control and enhancing the consistency between treatment output and the current coupling state.

[0055] This application further introduces a processing mechanism that generates contact recovery commands, re-acquires multi-source coupling observation data, and re-judges induced response changes before and after the execution of limited compensation. This mechanism enables the linkage of interface correction, contact correction, and dose compensation. As a result, it avoids simply increasing output parameters to maintain treatment when tissue interface abnormalities such as insufficient coupling medium, abnormal probe attachment, electrode position displacement, or changes in strap pressure can still be corrected. This reduces the risk of accumulated control deviations caused by a single compensation path and improves the operational stability and processing reliability of the acoustic-electric combined therapy device in dynamic attachment scenarios.

[0056] This application further determines the mismatch state by, after performing limited compensation, whether the recalculated joint coupling quality fraction continues to decrease and whether the changes in evoked responses obtained from adjacent consecutive acquisitions are all lower than the initial evoked response. Combined with the comparison results between the interface temperature rise and the initial interface temperature rise, a choice is made between terminating treatment and downgrading treatment. This enables a clear distinction of the effective dose mismatch state during the combined acoustic and electroacoustic therapy process, and allows subsequent treatment to simultaneously consider the needs for neuromuscular stimulation effect recovery and the thermal safety requirements of the ultrasound treatment interface, thereby improving the reliability of mismatch state identification and the targeted nature of treatment safety control.

[0057] Furthermore, this application establishes a continuous processing relationship between monitoring, judgment, compensation, and safety control in combined acoustic-electric therapy by setting up sequential connections for acoustic coupling attenuation index, electrical contact drift index, combined coupling quality fraction, contact recovery command, limited compensation, and mismatch state determination, rather than setting up multiple detection items in isolation. Therefore, this application not only improves the local processing defects of existing technologies in acoustic coupling assessment, electrical contact assessment, and treatment dose compensation, but also makes the overall control process for the combined application of ultrasound therapy and bioelectric stimulation have better continuity, accuracy, stability, and clinical application adaptability, which is more conducive to achieving reliable processing in biomedical engineering treatment devices. Attached Figure Description

[0058] Figure 1A schematic diagram of the coupling quality assessment and dose compensation method for combined acoustic and electrical therapy;

[0059] Figure 2 A schematic diagram of the logical structure of a coupling quality assessment and dose compensation system for combined acoustic and electrical therapy;

[0060] Figure 3 This is a schematic diagram of the contact restoration, limitation compensation, and mismatch control logic for combined acoustic and electrical therapy. Detailed Implementation

[0061] The technical solution of this application will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the embodiments and specific features in the embodiments are detailed descriptions of the technical solution of this application, rather than limitations thereof.

[0062] Example 1:

[0063] like Figure 1 and 3 As shown, this embodiment provides a method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy, as detailed below:

[0064] Before treatment, a reference coupling state was acquired, which included initial ultrasound reflection echo characteristics, initial interface temperature rise, initial coupling layer thickness, initial electrode contact impedance, initial local motion state, initial induced response, and initial output parameters.

[0065] The initial ultrasound reflection echo characteristics are the interface reflection characterization results obtained by sending detection pulses and receiving return echoes after the probe and the treatment site are attached before treatment. The initial ultrasound reflection echo characteristics are used to characterize the initial sound transmission conditions between the probe, coupling medium and treatment site. When collecting the initial ultrasound reflection echo characteristics, the probe attachment and coupling medium laying are completed first. Then, before entering the formal treatment output, a preset detection pulse is sent in detection mode to receive the echo signal returned from the interface and read the echo strength and echo morphology from the echo signal returned from the interface.

[0066] The echo strength is the maximum echo amplitude within the main echo segment, and the echo morphology is the envelope width of the main echo segment. The main echo segment is determined as follows: under the same detection mode, the surface echo of the probe and the surface echo of the action site are first identified according to the order of arrival of the echoes. Then, the continuous echo portion located between the surface echo of the probe and the surface echo of the action site, and whose echo amplitude is higher than the background of the adjacent echo, is determined as the main echo segment. The envelope width of the main echo segment is obtained by reading the time span between the start and end positions of the main echo segment and determining the corresponding time span as the echo morphology.

[0067] After determining the initial ultrasound reflection echo characteristics based on the echo intensity and morphology obtained from the first acquisition, to form a comparative basis for subsequent deviation judgments, under the conditions that the reference coupling state has been established, the probe position is not adjusted, the electrode position is not adjusted, the coupling medium laying state is not changed, and the human body is in the pre-treatment preparation state, the echo intensity is continuously acquired nine times and the echo morphology is continuously acquired nine times, following the same detection mode, the same acquisition path, and the same acquisition sequence. This results in ten consecutive acquisitions, which, together with the echo intensity and morphology obtained from the first acquisition, form ten consecutive acquisition results. A fixed time interval is maintained between two adjacent acquisitions of the ten consecutive acquisitions, with the fixed time interval set to 0.5 seconds and the total duration set to five seconds. During the ten consecutive acquisitions, if the local motion state corresponding to any acquisition changes in position or posture relative to the previous acquisition, the corresponding acquisition result is identified as an abnormal acquisition result and deleted. After deleting the abnormal acquisition result, re-acquisitions are performed under the same pre-treatment preparation state until ten valid acquisition results are retained.

[0068] After obtaining ten valid acquisition results, noise judgment is performed only on intermediate acquisition results other than the first and last acquisition results. For a certain intermediate acquisition result, the treatment device first calculates the first difference between the intermediate acquisition result and the previous acquisition result, and calculates the second difference between the intermediate acquisition result and the next acquisition result. The treatment device then calculates the differences between the remaining two adjacent acquisitions other than the first and second differences, and determines the maximum value of the remaining two adjacent acquisition differences as the preset noise difference upper limit. When an intermediate acquisition result is higher than both the previous and next acquisition results, and both the first and second differences are greater than the preset noise difference upper limit, the intermediate acquisition result is determined to be a noise acquisition result. When an intermediate acquisition result is lower than both the previous and next acquisition results, and both the first and second differences are greater than the preset noise difference upper limit, the intermediate acquisition result is determined to be a noise acquisition result.

[0069] After deleting the noise acquisition results, repeat the acquisition process under the same pre-treatment preparation conditions until ten valid acquisition results are obtained again. After retaining the ten valid acquisition results, read the maximum and minimum values ​​of the ten echo strength results, and determine the interval between the maximum and minimum values ​​as the natural fluctuation range corresponding to the echo strength. Read the maximum and minimum values ​​of the ten echo morphology results, and determine the interval between the maximum and minimum values ​​as the natural fluctuation range corresponding to the echo morphology. The subsequent judgment of the reflection deviation results is based on the natural fluctuation range corresponding to the echo strength and the natural fluctuation range corresponding to the echo morphology, respectively. When the current echo strength falls within the natural fluctuation range corresponding to the echo strength and the current echo morphology falls within the natural fluctuation range corresponding to the echo morphology, the reflection deviation result is determined to be no deviation. When the current echo strength exceeds the natural fluctuation range corresponding to the echo strength or the current echo morphology exceeds the natural fluctuation range corresponding to the echo morphology, the reflection deviation result is determined to be deviated.

[0070] It should be noted that, in this application, the natural fluctuation range is the interval determined by the maximum and minimum values ​​of the corresponding compared quantity in the continuous effective acquisition results under the reference coupling state; different compared quantities correspond to different natural fluctuation ranges, and the treatment device always reads the natural fluctuation range corresponding to the same compared quantity during subsequent comparisons.

[0071] In some implementations, the treatment device determines the natural fluctuation range corresponding to any compared quantity in the following manner:

[0072] ;

[0073] ;

[0074] ;

[0075] Where X represents the compared quantity, X is the echo strength, echo shape, initial interface temperature rise, initial electrode contact impedance, maximum displacement change, maximum attitude change, or initial induced response. This represents the i-th valid acquisition result; n represents the number of valid acquisitions, which is 10 in this embodiment. This represents the natural fluctuation range corresponding to the compared quantity X; This represents the lower limit of the natural fluctuation range corresponding to the compared quantity X; This represents the upper limit of the natural fluctuation range corresponding to the compared quantity X; the number of effective acquisitions n is determined by the results of ten effective acquisitions.

[0076] For the current comparison quantity corresponding to the current acquisition time k The treatment device determines the deviation result corresponding to the compared quantity X in the following manner:

[0077] ;

[0078] in, This represents the comparison quantity corresponding to the current acquisition time k. No deviation; This represents the comparison quantity corresponding to the current acquisition time k. It has deviated.

[0079] Regarding the difference in coupling layer thickness, the treatment device determines the natural fluctuation range and thickness deviation corresponding to the difference in coupling layer thickness as follows:

[0080] ;

[0081] ;

[0082] ;

[0083] in, Indicates the initial coupling layer thickness; This indicates the current coupling layer thickness corresponding to the current acquisition time k; This represents the difference in coupling layer thickness corresponding to the current acquisition time k; This represents the lower limit of the natural fluctuation range corresponding to the initial coupling layer thickness; This represents the upper limit of the natural fluctuation range corresponding to the initial coupling layer thickness; This indicates the natural fluctuation range corresponding to the difference in coupling layer thickness; This indicates a deviation in thickness from the result.

[0084] The initial interface temperature rise is the increase in temperature of the probe contact interface relative to the pre-output interface under the initial output parameters before treatment. The initial interface temperature rise is used to characterize the thermal response at the interface under the initial bonding conditions. When acquiring the initial interface temperature rise, the pre-output interface temperature is read first, then a short-term trial output is performed according to the initial output parameters, and then the interface temperature is read again. The change in interface temperature between the two tests is determined as the initial interface temperature rise. The initial coupling layer thickness is the thickness of the coupling medium formed between the probe and the treatment site before treatment. The initial coupling layer thickness is used to characterize the medium occupancy of the initial sound transmission path. When acquiring the initial coupling layer thickness, after the probe is attached, the interface echo is acquired using the ultrasonic channel. The gap thickness between the probe and the treatment site is determined based on the sequential relationship between the probe surface echo and the treatment site surface echo. The corresponding thickness result is determined as the initial coupling layer thickness.

[0085] The initial electrode contact impedance is the initial conductive impedance formed after the electrode comes into contact with the skin before treatment. The initial electrode contact impedance is used to characterize the initial contact conditions of the electrical stimulation path. When collecting the initial electrode contact impedance, the detection current is output by the electrical stimulation channel before the formal treatment output, and the corresponding voltage response is collected at the same time. The impedance result between the electrode and the skin is obtained based on the detection current and the corresponding voltage response. The impedance result obtained by the first contact detection is determined as the initial electrode contact impedance.

[0086] The initial local motion state refers to the initial motion of the treatment site and electrode attachment area during the preparation phase before treatment. This initial local motion state characterizes the local human activity conditions corresponding to the electrode and probe positions before treatment begins. When acquiring the initial local motion state, displacement and posture changes near the treatment site are continuously acquired after probe and electrode attachment and before formal treatment output. The acquisition method involves fixing displacement and posture detectors near the treatment site, or fixing a detection device capable of simultaneously outputting displacement and posture change results. The current position and orientation when probe and electrode attachment are completed and the human body enters the pre-treatment preparation state are used as reference starting points. The current position is used as a comparison benchmark for displacement changes, and the current orientation is used as a comparison benchmark for posture changes. The displacement change is represented by the positional change of the detection position relative to the reference starting point within the attachment plane, and the posture change is represented by the rotational change of the detection position relative to the reference starting point.

[0087] To ensure consistency in comparisons before and after treatment, the installation positions of the displacement detector and posture detector remain unchanged during the same treatment process, or the installation positions of the corresponding detection devices remain unchanged, and the reference starting point is not reset. For example, in the pre-treatment preparation state, ten displacement change results and ten posture change results are continuously collected at fixed time intervals, with the fixed time interval set to 0.5 seconds and the total duration set to 5 seconds. If any active limb movement, probe position adjustment, or electrode position adjustment occurs during any collection process, the corresponding collection result is deleted, and a new collection is made after returning to the pre-treatment preparation state until ten valid collection results are obtained. After obtaining ten valid collection results, the maximum displacement change value is read from the ten displacement change results, and the maximum posture change value is read from the ten posture change results. The maximum displacement change value is obtained by taking the absolute value of each of the ten displacement change results and reading the maximum value. The maximum posture change value is obtained by taking the absolute value of each of the ten posture change results and reading the maximum value. The maximum displacement change value and the maximum posture change value are then used together to determine the initial local motion state.

[0088] After determining the maximum displacement change and the maximum posture change as the initial local motion state, in order to form a comparative basis for subsequent deviation judgment, the same acquisition path and the same acquisition sequence are continued under the same pre-treatment preparation state. For example, the maximum displacement change is acquired nine times consecutively, and the maximum posture change is acquired nine times consecutively, thus forming ten consecutive acquisition results together with the first obtained maximum displacement change and the first obtained maximum posture change. After performing abnormal acquisition result deletion, noise acquisition result deletion and re-acquisition processing on the ten consecutive acquisition results of maximum displacement change and the ten consecutive acquisition results of maximum posture change, the maximum and minimum values ​​in the ten consecutive acquisition results of maximum displacement change are read, and the interval between the maximum and minimum values ​​is determined as the natural fluctuation range corresponding to the maximum displacement change. The maximum and minimum values ​​in the ten consecutive acquisition results of maximum posture change are read, and the interval between the maximum and minimum values ​​is determined as the natural fluctuation range corresponding to the maximum posture change.

[0089] The subsequent acquisition and comparison of local motion states are also carried out in the same way. That is, within the corresponding acquisition period, the current displacement change result and the current attitude change result are obtained first. Then, the maximum displacement change value in the current displacement change result and the maximum attitude change value in the current attitude change result are read respectively, and the current displacement change value and the current attitude change value are jointly determined as the local motion state. The judgment of subsequent motion deviation results is based on the natural fluctuation range corresponding to the maximum displacement change value and the natural fluctuation range corresponding to the maximum attitude change value, respectively. When the current displacement change value falls within the natural fluctuation range corresponding to the maximum displacement change value, and the current attitude change value falls within the natural fluctuation range corresponding to the maximum attitude change value, the motion deviation result is determined as no deviation. When the current displacement change value exceeds the natural fluctuation range corresponding to the maximum displacement change value, or the current attitude change value exceeds the natural fluctuation range corresponding to the maximum attitude change value, the motion deviation result is determined as deviation.

[0090] The initial evoked response is the initial response result generated by the target tissue and detected by the treatment device after the initial output parameters are applied to the target tissue. The initial evoked response is used to characterize the initial effect after the effective stimulus has been transmitted to the target tissue under the reference coupling state. When acquiring the initial evoked response, after the probe and electrode are attached, a short-term trial output is performed according to the initial output parameters, and the response signal corresponding to the target tissue is acquired simultaneously. The acquisition method of the response signal is as follows: before the start of treatment, the response signal type, detection site, detection window, and characteristic amplitude value method used in the same treatment process are determined. The response signal type is an electromyographic response signal or a displacement response signal. The detection site is the fixed detection position corresponding to the target tissue that remains unchanged in the same treatment process. The detection window is determined based on the time interval of the first amplitude change of the response signal after the short-term trial output. The characteristic amplitude value method is to read the response value with the largest absolute amplitude from the detection window. Before performing a short-term trial output according to the initial output parameters, the treatment device first acquires the pre-output response signal within the same detection site and the same detection window length, and determines the maximum absolute amplitude value in the pre-output response signal as the pre-output response value.

[0091] The treatment initiation conditions are as follows: the short-time trial output is executed completely according to the initial output parameters, the response signal in the detection window is not judged as an invalid response signal, and the characteristic amplitude read in the detection window is higher than the response value before output; when the characteristic amplitude corresponding to a certain short-time trial output first meets the treatment initiation conditions, the characteristic amplitude corresponding to that short-time trial output is determined as the initial induced response.

[0092] By defining the sensor type, reference starting point, representation form, number of consecutive acquisitions, fixed time interval, and deletion and re-acquisition method for the initial local motion state, the acquisition and subsequent comparison process of the initial local motion state have a clear data basis, thus enabling the initial local motion state to serve as an effective input in the calculation of the electrical contact drift index.

[0093] The initial output parameters are the initial output settings used to form the initial evoked response before treatment. The initial output parameters include ultrasound output parameters and electrical stimulation output parameters. The ultrasound output parameters include ultrasound intensity and duty cycle, and the electrical stimulation output parameters include electrical stimulation current and pulse width. When acquiring the initial output parameters, the initial output settings are first completed according to the preset treatment plan, and then a short-term trial output is performed. At the same time as obtaining the initial evoked response, the currently effective output settings of the treatment device are read. The ultrasound output parameters and electrical stimulation output parameters read are jointly determined as the initial output parameters. The initial ultrasound reflection echo characteristics, initial interface temperature rise, and initial coupling layer thickness in the reference coupling state are used to characterize the initial conditions of the acoustic transmission interface. The initial electrode contact impedance and initial local motion state in the reference coupling state are used to characterize the initial conditions of the electrical stimulation contact interface. The initial evoked response and initial output parameters in the reference coupling state are used to characterize the response result and corresponding output basis when an effective effect has been formed under the initial conditions.

[0094] Collecting data from the reference coupling state serves two purposes. First, it establishes a benchmark for comparison under the same subject, the same application process, and the same initial output settings before treatment begins. This ensures that the multi-source coupling observation data continuously acquired during treatment can be compared one-to-one with the reference coupling state, thereby obtaining the acoustic coupling attenuation index and the electrical contact drift index. Second, it correlates the interface transmission conditions with the target tissue response results, avoiding judgment of the treatment status based solely on a single temperature result, a single impedance result, or a single evoked response result. With the reference coupling state fully acquired, the combined coupling quality score can reflect whether the acoustic transmission interface has deviated, whether the electrical stimulation contact interface has deviated, and whether the deviation has affected the initial evoked response. This provides a unified basis for subsequent execution of limited compensation, generation of contact recovery commands, and determination of mismatch status.

[0095] Multi-source coupled observation data were continuously acquired during the treatment process. The multi-source coupled observation data included ultrasonic reflection echo characteristics, interface temperature rise, coupling layer thickness difference, electrode contact impedance, local motion state, and induced response changes. Among them, the ultrasonic reflection echo characteristics were the interface reflection characterization results repeatedly acquired during the treatment process under the conditions of continuous probe attachment and continuous treatment output. Compared with the initial ultrasonic reflection echo characteristics, the ultrasonic reflection echo characteristics reflected the sound transmission conditions at the current moment during the treatment. When acquiring ultrasonic reflection echo characteristics, a detection pulse was inserted and the return echo was received without stopping the treatment process. The intensity and shape of the echo acquired at the moment were determined as the ultrasonic reflection echo characteristics.

[0096] Interface temperature rise is the increase in temperature of the probe contact interface under the current output conditions relative to the interface temperature before the start of treatment during the treatment process. Compared with the initial interface temperature rise, the interface temperature rise reflects the real-time change of the interface thermal response during the treatment. When collecting interface temperature rise, the temperature of the probe contact interface is continuously read, and the current reading temperature is compared with the interface temperature read before the start of treatment. The obtained temperature change result is determined as the interface temperature rise.

[0097] The coupling layer thickness difference is the difference between the current coupling layer thickness and the initial coupling layer thickness during treatment. Compared with the initial coupling layer thickness, the coupling layer thickness difference reflects the changes in the distribution of the coupling medium and the adhesion interval during treatment. When collecting the coupling layer thickness difference, the ultrasound channel is used to repeatedly collect the surface echo of the probe and the surface echo of the treatment site. The current interval thickness is determined based on the sequential relationship between the two types of echoes. The current interval thickness is then compared with the initial coupling layer thickness, and the thickness difference obtained by subtracting the initial coupling layer thickness from the current coupling layer thickness is determined as the coupling layer thickness difference. When the current coupling layer thickness is higher than the initial coupling layer thickness, the coupling layer thickness difference is positive; when the current coupling layer thickness is lower than the initial coupling layer thickness, the coupling layer thickness difference is negative; when the current coupling layer thickness is the same as the initial coupling layer thickness, the coupling layer thickness difference is zero. Accordingly, the coupling layer thickness difference corresponds to a single thickness difference result at each current acquisition moment, which can be directly used in subsequent comparisons of natural fluctuation ranges and determination of thickness deviation results.

[0098] Electrode contact impedance is the conductive impedance result formed by the contact path between the electrode and the skin at the current moment during the treatment process. Compared with the initial electrode contact impedance, the electrode contact impedance reflects whether the electrical stimulation contact conditions have deviated during the treatment. When collecting electrode contact impedance, the detection current is output by the electrical stimulation channel during the treatment output interval or detection period, and the corresponding voltage response is collected simultaneously. The current impedance result is obtained based on the detection current and the corresponding voltage response, and the current impedance result is determined as the electrode contact impedance.

[0099] Local motion state refers to the motion of the treatment site and electrode attachment area at the current moment during the treatment process. Compared with the initial local motion state, the local motion state reflects the impact of local human activities on probe and electrode attachment during the treatment. When collecting local motion state data, displacement or posture changes near the treatment site are continuously collected during the treatment process, and the current continuous change results are determined as the local motion state.

[0100] Evoked response change refers to the change in the response result produced after the current output acts on the target tissue during treatment, relative to the initial evoked response. Compared with the initial evoked response, the evoked response change reflects whether the result after the effective stimulus reaches the target tissue during treatment has changed. When collecting evoked response changes, the type of response signal and the detection site used in this treatment are determined before the reference coupling state is established. The response signal type is either an electromyographic response signal or a displacement response signal, and the response signal type remains unchanged during the same treatment. When the response signal type is an electromyographic response signal, the detection site is determined as a fixed attachment position on the surface of the corresponding muscle group of the target tissue. When the response signal type is a displacement response signal, the detection site is determined as a fixed acquisition position on the surface of the action site. The method for determining the detection site is to complete the attachment or positioning of the detection device before collecting the initial evoked response, and to keep the detection site unchanged during subsequent treatment.

[0101] When collecting changes in the induced response, the response signal is continuously collected within a pre-set detection window after each current output begins. The detection window is a fixed collection period that remains unchanged during the same treatment process. The detection window is set by first performing a short-term trial output according to the initial output parameters in the reference coupling state and continuously collecting the response signal. Then, the time interval of the first occurrence of the initial induced response is determined from the continuously collected response signals, and the time interval of the first occurrence of the initial induced response is determined as the detection window. In subsequent treatment processes, the current response result is collected within the same detection window corresponding to the initial induced response.

[0102] To eliminate interference from the treatment output itself, values ​​are not directly taken at the start and end times of the current output, but only within the detection window. To eliminate motion artifacts, the current displacement change result and the current posture change result are first read at the corresponding times in the detection window, and then the maximum value of the current displacement change and the maximum value of the current posture change are read from the current displacement change result and the current posture change result, respectively. When the maximum value of the current displacement change exceeds the natural fluctuation range corresponding to the maximum displacement change, or when the maximum value of the current posture change exceeds the natural fluctuation range corresponding to the maximum posture change, the current response signal is determined to be an invalid response signal, and it is re-acquired during the next current output action. When the maximum value of the current displacement change falls within the natural fluctuation range corresponding to the maximum displacement change, and the maximum value of the current posture change falls within the natural fluctuation range corresponding to the maximum posture change, the current response signal is determined to be a valid response signal.

[0103] After obtaining a valid response signal, a characteristic amplitude is uniformly adopted as the value selection method. The characteristic amplitude is obtained by reading the response value with the largest absolute amplitude from the valid response signals within the detection window, and determining the response value with the largest absolute amplitude as the current response result. When collecting the initial induced response, the same response signal type, the same detection location, the same detection window, and the same characteristic amplitude selection method are also used to obtain the initial induced response. After obtaining the current response result, the current response result is compared with the initial induced response, and the change obtained from the comparison is determined as the induced response change. By uniformly defining the response signal type, detection location, detection window, invalid response signal exclusion method, and characteristic amplitude selection method, the process of collecting and comparing induced response changes has a consistent data basis, thus providing a clear implementation basis for comparison results lower than the initial induced response.

[0104] Continuous acquisition of multi-source coupling observation data during treatment is essential to ensure that the treatment device continuously monitors the correspondence between the acoustic transmission interface, the electrical stimulation contact interface, and the target tissue response throughout the treatment process. Simply acquiring ultrasound reflection echo characteristics, interface temperature rise, and coupling layer thickness difference can determine if the coupling conditions between the probe and the treatment site have changed, but it cannot determine if the electrical stimulation path has simultaneously deviated. Similarly, acquiring only electrode contact impedance and local motion states can determine if electrode contact conditions have changed, but it cannot determine if the acoustic transmission interface has affected the treatment output. Acquiring only induced response changes can reveal changes in the target tissue response, but it cannot distinguish whether the change originates from acoustic coupling attenuation, electrical contact drift, or a combination of both. Therefore, continuous acquisition of multi-source coupling observation data provides a complete data foundation for subsequent calculations of the acoustic coupling attenuation index, electrical contact drift index, and joint coupling quality score.

[0105] Another advantage of continuously acquiring multi-source coupled observation data is that it provides a consistent basis for judgment in limiting compensation, contact recovery command generation, and mismatch state determination. When there are deviations in the characteristics of ultrasonic reflected echo, interface temperature rise, and coupling layer thickness difference, the direction of change of the acoustic transmission interface can be identified. When there are deviations in electrode contact impedance and local motion state, the direction of change of the electrical stimulation contact interface can be identified. When the evoked response changes below the initial evoked response, it can be identified that the current effective stimulation result has been affected. Under the condition of continuous updating of multi-source coupled observation data, the treatment device can continuously judge the current moment in the treatment process according to the same comparison basis, thereby avoiding compensation or termination of treatment based on only a single observation result.

[0106] The acoustic coupling attenuation index and electrical contact drift index are calculated based on the reference coupling state and multi-source coupling observation data; the joint coupling quality score is calculated based on the acoustic coupling attenuation index and electrical contact drift index.

[0107] Methods for calculating the acoustic coupling attenuation index include:

[0108] Read the initial ultrasonic reflection echo characteristics, initial interface temperature rise, and initial coupling layer thickness in the reference coupling state; read the ultrasonic reflection echo characteristics, interface temperature rise, and coupling layer thickness difference in the multi-source coupling observation data, and determine the reflection deviation result, temperature rise deviation result, and thickness deviation result, respectively; calculate the acoustic coupling attenuation index based on the reflection deviation result, temperature rise deviation result, and thickness deviation result.

[0109] In some embodiments, the method for determining the reflection deviation result, temperature rise deviation result, and thickness deviation result respectively includes: reading the initial ultrasound reflection echo characteristics and ultrasound reflection echo characteristics under the same detection mode; when determining the natural fluctuation range formed by continuous acquisition before treatment initiation, firstly, under the conditions that the reference coupling state has been established, the probe position and electrode position have been fixed, the coupling medium has been laid, and the formal treatment output has not yet started, keeping the treatment site in the pre-treatment preparation state; the pre-treatment preparation state specifically means keeping the body position unchanged during the acquisition of the reference coupling state, keeping the treatment site from performing active actions, keeping the probe position unchanged, and keeping the electrode position unchanged.

[0110] For example, in the pre-treatment preparation state, the echo intensity, echo morphology, initial interface temperature rise, and initial coupling layer thickness are continuously acquired ten times each, following the same detection mode, acquisition path, and acquisition sequence. A fixed time interval is maintained between two adjacent acquisitions, set to 0.5 seconds, and the total duration of the ten consecutive acquisitions is five seconds. During the ten consecutive acquisitions, if the local motion state corresponding to any acquisition changes in position or posture relative to the previous acquisition, the corresponding acquisition result is identified as an abnormal acquisition result and deleted. After deleting the abnormal acquisition result, re-acquisition is performed in the same pre-treatment preparation state until ten valid acquisition results are retained. After obtaining ten valid acquisition results, the echo intensity, echo morphology, interface temperature rise, and coupling layer thickness are smoothed according to the acquisition sequence. After deleting noisy acquisition results and re-acquiring, the interval between the maximum and minimum values ​​in the ten valid acquisition results is taken as the natural fluctuation range corresponding to the echo intensity, the echo morphology, the initial interface temperature rise, and the initial coupling layer thickness, respectively.

[0111] After obtaining the natural fluctuation ranges corresponding to echo strength, echo shape, initial interface temperature rise, and initial coupling layer thickness, the reflection deviation, temperature rise deviation, and thickness deviation results are determined respectively. When the current echo strength falls within the natural fluctuation range corresponding to the echo strength and the current echo shape falls within the natural fluctuation range corresponding to the echo shape, the reflection deviation result is determined as no deviation. When the current echo strength exceeds the natural fluctuation range corresponding to the echo strength, or the current echo shape exceeds the natural fluctuation range corresponding to the echo shape, the reflection deviation result is determined as deviation. When the interface temperature rise falls within the natural fluctuation range corresponding to the initial interface temperature rise, the temperature rise deviation result is determined as no deviation. When the interface temperature rise exceeds the natural fluctuation range corresponding to the initial interface temperature rise, the temperature rise deviation result is determined as deviation.

[0112] Since the coupling layer thickness difference is used to characterize the difference between the current coupling layer thickness and the initial coupling layer thickness, when judging the thickness deviation result, the maximum and minimum thickness results in the natural fluctuation range corresponding to the initial coupling layer thickness are first read. Then, the initial coupling layer thickness is subtracted from the maximum thickness result and the initial coupling layer thickness is subtracted from the minimum thickness result, respectively, to obtain the upper and lower bounds of the thickness variation range. The interval jointly defined by the upper and lower bounds of the thickness variation range is determined as the natural fluctuation range corresponding to the coupling layer thickness difference. When the coupling layer thickness difference falls within the natural fluctuation range corresponding to the coupling layer thickness difference, the thickness deviation result is determined as not deviating. When the coupling layer thickness difference exceeds the natural fluctuation range corresponding to the coupling layer thickness difference, the thickness deviation result is determined as deviating.

[0113] By explicitly defining the thickness difference of the coupling layer as a single thickness difference and explicitly defining the subsequent comparison basis as the natural fluctuation range corresponding to the thickness difference of the coupling layer, the judgment process of the thickness deviation result has a unified parameter caliber and a clear comparison basis.

[0114] In some embodiments, the method for calculating the acoustic coupling attenuation index based on the reflection deviation result, the temperature rise deviation result, and the thickness deviation result includes: pre-setting a plurality of sequentially increasing candidate values ​​for the acoustic coupling attenuation index in the treatment device, the plurality of candidate values ​​including a minimum value, a first increasing value, a second increasing value, and a third increasing value.

[0115] The method for setting multiple candidate values ​​is as follows: first, the acoustic transmission interface corresponding to the reference coupling state is determined as the initial comparison benchmark. Then, according to the increase in the number of deviation results corresponding to the increase in the degree of deviation of the acoustic transmission interface, the multiple candidate values ​​are arranged in sequence. Among them, the minimum value corresponds to the no-deviation state, the first incremental value corresponds to the single-deviation state, the second incremental value corresponds to the two-deviation state, and the third incremental value corresponds to the three-deviation state.

[0116] After reading the reflection deviation result, if the reflection deviation result is no deviation, the acoustic coupling attenuation index is set to the minimum value; if the reflection deviation result is deviation, the acoustic coupling attenuation index is adjusted from the minimum value to the first incremental value. After reading the thickness deviation result, if the thickness deviation result is deviation and the current acoustic coupling attenuation index is the minimum value, the acoustic coupling attenuation index is adjusted to the first incremental value; if the thickness deviation result is deviation and the current acoustic coupling attenuation index is the first incremental value, the acoustic coupling attenuation index is adjusted to the second incremental value; if the thickness deviation result is no deviation, the value is maintained. Keep the current acoustic coupling attenuation index unchanged; after reading the temperature rise deviation result, if the temperature rise deviation result is already deviated and the current acoustic coupling attenuation index is at its minimum value, adjust the acoustic coupling attenuation index to the first incremental value; if the temperature rise deviation result is already deviated and the current acoustic coupling attenuation index is at its first incremental value, adjust the acoustic coupling attenuation index to the second incremental value; if the temperature rise deviation result is already deviated and the current acoustic coupling attenuation index is at its second incremental value, adjust the acoustic coupling attenuation index to the third incremental value; if the temperature rise deviation result is not deviated, keep the current acoustic coupling attenuation index unchanged.

[0117] To reflect the persistence of deviations, after determining the current values ​​for the reflection deviation, thickness deviation, and temperature rise deviation results, the reflection deviation, thickness deviation, and temperature rise deviation results from adjacent consecutive acquisition times are read. If the reflection deviation, thickness deviation, and temperature rise deviation results continue to show deviations in adjacent consecutive acquisition times, and the current acoustic coupling attenuation index is lower than the third incrementing value, the acoustic coupling attenuation index is adjusted to the next candidate value until it reaches the third incrementing value. If the reflection deviation, thickness deviation, and temperature rise deviation results do not show deviations in adjacent consecutive acquisition times, the current acoustic coupling attenuation index remains unchanged.

[0118] Methods for calculating the electrical contact drift index include:

[0119] Read the initial electrode contact impedance and initial local motion state in the reference coupling state; read the electrode contact impedance, local motion state and induced response changes in the multi-source coupling observation data, and determine the impedance deviation result, motion deviation result and response deviation result respectively; calculate the electrical contact drift index based on the impedance deviation result, motion deviation result and response deviation result.

[0120] In some embodiments, the method for determining the impedance deviation result, motion deviation result, and response deviation result includes: reading the initial electrode contact impedance and the electrode contact impedance, and comparing the impedance changes; when the electrode contact impedance falls within the natural fluctuation range corresponding to the initial electrode contact impedance, the impedance deviation result is determined as no deviation; when the electrode contact impedance exceeds the natural fluctuation range corresponding to the initial electrode contact impedance, the impedance deviation result is determined as a deviation; then reading the initial local motion state and the local motion state, and comparing the current maximum displacement change with the natural fluctuation range corresponding to the maximum displacement change, and the current maximum attitude change with the natural fluctuation range corresponding to the maximum attitude change; when the current maximum displacement change falls within the natural fluctuation range corresponding to the maximum displacement change, and the current maximum attitude change falls within the natural fluctuation range corresponding to the maximum attitude change... When the maximum value is within the natural fluctuation range, the motion deviation result is determined as no deviation. When the maximum value of the current displacement change exceeds the natural fluctuation range corresponding to the maximum displacement change, or when the maximum value of the current attitude change exceeds the natural fluctuation range corresponding to the maximum attitude change, the motion deviation result is determined as deviation. Then, the initial evoked response and the evoked response change are read, and the difference between the current response result and the initial evoked response is compared. When the evoked response change indicates that the current response result is not lower than the initial evoked response, or the current response result is lower than the initial evoked response but still within the natural fluctuation range corresponding to the initial evoked response, the response deviation result is determined as no deviation. When the evoked response change indicates that the current response result is lower than the initial evoked response and exceeds the natural fluctuation range corresponding to the initial evoked response, the response deviation result is determined as deviation.

[0121] In some embodiments, the method for calculating the electrical contact drift index based on impedance deviation results, motion deviation results, and response deviation results includes: pre-setting multiple candidate values ​​for the electrical contact drift index in the treatment device in an ascending order, the multiple candidate values ​​including a minimum value, a first ascending value, a second ascending value, a third ascending value, a fourth ascending value, and a fifth ascending value; the method for setting the multiple candidate values ​​is as follows: first, the electrical stimulation contact interface corresponding to the reference coupling state is determined as the initial comparison benchmark, and then, according to the principle that an increase in the number of deviation results corresponds to an increase in the degree of deviation of the electrical stimulation contact interface, and an increase in the duration of deviation corresponds to an increase in the drift risk of the electrical stimulation contact interface, the multiple candidate values ​​are arranged sequentially.

[0122] Among them, the minimum value corresponds to the state of no deviation, the first incrementing value corresponds to the state of single deviation, the second incrementing value corresponds to the state of two deviations, the third incrementing value corresponds to the state of three deviations, the fourth incrementing value corresponds to the state of continuous interface deviation, and the fifth incrementing value corresponds to the state of continuous interface deviation and continuous decrease in induced response.

[0123] After reading the impedance deviation result, if the impedance deviation result is no deviation, the electrical contact drift index is set to the minimum value; if the impedance deviation result is a deviation, the electrical contact drift index is adjusted from the minimum value to the first incremental value. After reading the motion deviation result, if the motion deviation result is a deviation and the current electrical contact drift index is the minimum value, the electrical contact drift index is adjusted to the first incremental value; if the motion deviation result is a deviation and the current electrical contact drift index is the first incremental value, the electrical contact drift index is adjusted to the second incremental value; if the motion deviation result is no deviation, the current electrical contact drift index remains unchanged.

[0124] After reading the response deviation result, if the response deviation result indicates deviation and the current electrical contact drift index is at its minimum value, the electrical contact drift index is adjusted to the first incrementing value. If the response deviation result indicates deviation and the current electrical contact drift index is at its first incrementing value, the electrical contact drift index is adjusted to the second incrementing value. If the response deviation result indicates deviation and the current electrical contact drift index is at its second incrementing value, the electrical contact drift index is adjusted to the third incrementing value. If the response deviation result indicates no deviation, the current electrical contact drift index remains unchanged.

[0125] After determining the current values ​​for impedance deviation, motion deviation, and response deviation, the impedance deviation, motion deviation, and response deviation results from adjacent consecutive acquisition times are read. If the impedance deviation and motion deviation results continuously show deviation in adjacent consecutive acquisition times, and the current electrical contact drift index is lower than the fourth incrementing value, the electrical contact drift index is adjusted to the next candidate value until it reaches the fourth incrementing value. If the impedance deviation and motion deviation results do not continuously show deviation in adjacent consecutive acquisition times, the current electrical contact drift index remains unchanged. Based on this, if the response deviation results continuously show deviation in adjacent consecutive acquisition times, and the current electrical contact drift index is lower than the fifth incrementing value, the electrical contact drift index is adjusted to the next candidate value until it reaches the fifth incrementing value. If the response deviation results do not continuously show deviation in adjacent consecutive acquisition times, the current electrical contact drift index remains unchanged.

[0126] Methods for calculating the joint coupling quality score include:

[0127] Acoustic sub-quality values ​​are generated based on the acoustic coupling attenuation index; electrical contact sub-quality values ​​are generated based on the electrical contact drift index, where an increase in the acoustic coupling attenuation index corresponds to a decrease in the acoustic sub-quality value, and an increase in the electrical contact drift index corresponds to a decrease in the electrical contact sub-quality value; the acoustic and electrical contact sub-quality values ​​are compared on the same score scale, and the sub-quality value with the smaller value is determined as the base quality value; the base quality value is corrected by combining the deviation of the induced response change from the initial induced response, to obtain the joint coupling quality score.

[0128] In some embodiments, the method for generating acoustic sub-item quality values ​​based on the acoustic coupling attenuation index includes: setting multiple preset scores in the treatment device that correspond one-to-one with the acoustic coupling attenuation index according to the number of candidate values ​​of the acoustic coupling attenuation index; the multiple preset scores include a maximum score, a first reduction score, a second reduction score, and a third reduction score; the method for setting the multiple preset scores is as follows: first, the acoustic transmission interface under the reference coupling state is determined as the quality benchmark, and the quality result corresponding to the reference coupling state is determined as the maximum score; then, according to the acoustic conditions under which the device allows continued treatment, the first reduction score, the second reduction score, and the third reduction score are set sequentially in order of increasing degree of deviation of the acoustic transmission interface.

[0129] The first reduction score corresponds to a single deviation in the acoustic transmission interface, but still meets the acoustic conditions for continued treatment. The second reduction score corresponds to two deviations in the acoustic transmission interface, but still meets the acoustic conditions for continued treatment. The third reduction score corresponds to three deviations in the acoustic transmission interface, or continuous deviations and the third reduction score is within the preset range for continued treatment, and the difference between the third reduction score and the preset lower limit for continued treatment is not greater than the preset lower limit margin. Multiple preset scores are set in descending order so that as the degree of deviation of the acoustic transmission interface increases, the acoustic sub-item quality values ​​decrease in the corresponding order.

[0130] The preset allowable range for continued treatment is determined based on the acoustic output safety limit, interface temperature rise safety limit, and allowable deviation limit of coupling layer thickness of the treatment device; the preset lower limit for continued treatment is the lowest score in the preset allowable range for continued treatment; the preset lower limit margin is determined based on the minimum difference between two adjacent preset scores among multiple preset scores.

[0131] After setting multiple preset scores, a correspondence is established between the acoustic coupling attenuation index and the acoustic sub-item quality values. Specifically, the minimum value is assigned to the maximum score, the first incremental value to the first decreasing score, the second incremental value to the second decreasing score, and the third incremental value to the third decreasing score. After reading the current acoustic coupling attenuation index, when the current acoustic coupling attenuation index is the minimum value, the maximum score corresponding to the minimum value is directly read as the acoustic sub-item quality value; when the current acoustic coupling attenuation index is the first incremental value, the first decreasing score corresponding to the first incremental value is directly read as the acoustic sub-item quality value; when the current acoustic coupling attenuation index is the second incremental value, the second decreasing score corresponding to the second incremental value is directly read as the acoustic sub-item quality value; when the current acoustic coupling attenuation index is the third incremental value, the third decreasing score corresponding to the third incremental value is directly read as the acoustic sub-item quality value.

[0132] In some embodiments, the method for generating electrical contact sub-item quality values ​​based on the electrical contact drift index includes: setting multiple preset scores in the treatment device that correspond one-to-one with the electrical contact drift index according to the number of candidate values ​​for the electrical contact drift index; the multiple preset scores include a maximum score, a first reduction score, a second reduction score, a third reduction score, a fourth reduction score, and a fifth reduction score; the method for setting the multiple preset scores is as follows: first, the electrical stimulation contact interface under the reference coupling state is determined as the quality benchmark, and the quality result corresponding to the reference coupling state is determined as the maximum score; then, according to the electrical contact conditions that allow the device to continue treatment, the first reduction score, the second reduction score, the third reduction score, the fourth reduction score, and the fifth reduction score are set sequentially in order of the degree of deviation of the electrical stimulation contact interface from low to high and the duration of deviation from short to long.

[0133] The preset score reduction is defined as follows: the first reduction corresponds to a single deviation of the electrical stimulation contact interface, but still meets the electrical contact conditions for continued treatment; the second reduction corresponds to two deviations of the electrical stimulation contact interface, but still meets the conditions for continued treatment; the third reduction corresponds to three deviations of the electrical stimulation contact interface, but still meets the conditions for continued treatment; the fourth reduction corresponds to continuous deviation of the electrical stimulation contact interface, with the fourth reduction score within the preset range for continued treatment, and the difference between the fourth reduction score and the preset lower limit for continued treatment not exceeding the preset lower limit margin; the fifth reduction corresponds to continuous deviation of the electrical stimulation contact interface accompanied by changes in the evoked response, indicating that the current response result is lower than the initial evoked response, and the fifth reduction score within the preset range for continued treatment, and the difference between the fifth reduction score and the preset lower limit for continued treatment not exceeding the preset lower limit margin; multiple preset scores are set in descending order so that when the degree of deviation of the electrical stimulation contact interface increases or the duration of deviation increases, the quality value of the electrical contact sub-items decreases in the corresponding order.

[0134] The preset allowable range for continued treatment of the sub-item quality value of electrical contact is determined based on the safety limit of the electrical stimulation output of the treatment device, the allowable range of electrode contact impedance, the allowable range of local motion state, and the allowable range of decrease in induced response; the preset lower limit for continued treatment of the sub-item quality value of electrical contact is the lowest score in the preset allowable range for continued treatment; the preset lower limit margin for the sub-item quality value of electrical contact is determined based on the minimum difference between two adjacent preset scores among multiple preset scores.

[0135] After setting multiple preset scores, a correspondence is established between the electrical contact drift index and the electrical contact sub-item quality value. Specifically, the minimum value corresponds to the maximum score, the first increasing value corresponds to the first decreasing score, the second increasing value corresponds to the second decreasing score, the third increasing value corresponds to the third decreasing score, the fourth increasing value corresponds to the fourth decreasing score, and the fifth increasing value corresponds to the fifth decreasing score. After reading the current electrical contact drift index, when the current electrical contact drift index is the minimum value, the highest score corresponding to the minimum value is directly read as the electrical contact sub-item quality value; when the current electrical contact drift index is the first increasing value, the highest score corresponding to the first increasing value is directly read as the electrical contact sub-item quality value. The first decreasing score corresponding to the current electrical contact drift index is taken as the electrical contact sub-item quality value; when the current electrical contact drift index is the second increasing value, the second decreasing score corresponding to the second increasing value is directly read as the electrical contact sub-item quality value; when the current electrical contact drift index is the third increasing value, the third decreasing score corresponding to the third increasing value is directly read as the electrical contact sub-item quality value; when the current electrical contact drift index is the fourth increasing value, the fourth decreasing score corresponding to the fourth increasing value is directly read as the electrical contact sub-item quality value; when the current electrical contact drift index is the fifth increasing value, the fifth decreasing score corresponding to the fifth increasing value is directly read as the electrical contact sub-item quality value.

[0136] An increase in the acoustic coupling attenuation index corresponds to a decrease in the acoustic sub-item quality value, and an increase in the electrical contact drift index corresponds to a decrease in the electrical contact sub-item quality value. The specific reasons are as follows: the acoustic coupling attenuation index characterizes the degree of deviation of the current acoustic transmission interface from the reference coupling state, and the electrical contact drift index characterizes the degree of deviation of the current electrical stimulation contact interface from the reference coupling state. When the acoustic coupling attenuation index increases, it indicates that the deviations corresponding to the ultrasound reflection echo characteristics, interface temperature rise, and coupling layer thickness difference are increasing, and the current ultrasound transmission conditions have changed more significantly relative to the reference coupling state. When the electrical contact drift index increases, it indicates that the deviations corresponding to the changes in electrode contact impedance, local motion state, and evoked response are increasing, and the current electrical stimulation contact conditions have changed more significantly relative to the reference coupling state. In combined therapy, an increase in interface deviation means a decrease in effective stimulation transmission conditions. Therefore, designing the acoustic coupling attenuation index and the electrical contact drift index to correspond inversely to the acoustic and electrical contact sub-item quality values ​​ensures that the quality results are consistent with the direction of change in the coupling state.

[0137] Comparing the acoustic and electrical contact sub-quality values ​​on the same scoring scale, and determining the lower-valued sub-quality value as the baseline quality value, is based on the following reasons: the effectiveness of combined acoustic and electrical therapy is determined by both ultrasound transmission and electrical stimulation contact conditions; when the acoustic sub-quality value is higher than the electrical contact sub-quality value, the electrical stimulation contact condition has become a limiting factor in the current treatment process; similarly, when the electrical contact sub-quality value is higher than the acoustic sub-quality value, the acoustic transmission condition has become a limiting factor in the current treatment process. Comparing the acoustic and electrical contact sub-quality values ​​on the same scoring scale, and determining the lower-valued sub-quality value as the baseline quality value, allows the baseline quality value to directly reflect the quality level of the current limiting factor, thus avoiding a situation where a higher quality result on one side masks a decline in the quality result on the other side.

[0138] In some embodiments, the method for correcting the baseline quality value based on the deviation of the evoked response change from the initial evoked response to obtain the joint coupling quality score includes: pre-arranging all possible scores corresponding to the baseline quality value in descending order; the method for setting all possible scores corresponding to the baseline quality value is to arrange multiple preset scores used to represent the quality of the coupling state in descending order according to the conditions under which the device allows continued treatment and the quality benchmark corresponding to the reference coupling state; since the baseline quality value comes from the lower value of the acoustic sub-quality value and the electrical contact sub-quality value, the baseline quality value must correspond to one of the aforementioned multiple preset scores; after reading the baseline quality value, the initial evoked response, and the evoked response change, first determining the baseline quality value in the following steps... The current position among multiple preset scores; when the change in the induced response indicates that the current response result is not lower than the initial induced response, or the current response result is lower than the initial induced response but still within the natural fluctuation range corresponding to the initial induced response, the baseline quality value remains unchanged at the current position, and the preset score corresponding to the current position is determined as the joint coupling quality score; when the change in the induced response indicates that the current response result is lower than the initial induced response and occurs at a single current acquisition time, the baseline quality value is adjusted from the current position to the next lower preset score, and the next lower preset score is determined as the joint coupling quality score; when the baseline quality value at the current position already corresponds to the lowest preset score, it is no longer adjusted downwards, and the lowest preset score is determined as the joint coupling quality score.

[0139] When the induced response changes at at least two adjacent acquisition times indicate that the current response result is lower than the initial induced response, the current position is further adjusted to the next lower preset score based on the correction at a single current acquisition time, and the next lower preset score is determined as the joint coupling quality score. When the correction result at a single current acquisition time already corresponds to the lowest preset score, the lowest preset score is kept unchanged, and the lowest preset score is determined as the joint coupling quality score. When the induced response change returns to the natural fluctuation range corresponding to the initial induced response, the downward adjustment result already executed at the previous acquisition time is not continued. Instead, the current position of the current basic quality value among multiple preset scores is reread, and the correction is re-executed according to the induced response change at the current acquisition time to obtain the joint coupling quality score at the current time.

[0140] By correcting the baseline quality value, a joint coupling quality score is obtained. The baseline quality value reflects the limiting links between the acoustic transmission interface and the electrical stimulation contact interface, while the evoked response change reflects the actual response result at the target tissue level. Using the baseline quality value and the evoked response change together can distinguish between situations where interface deviation has not yet affected the initial evoked response and situations where interface deviation has caused a decrease in the initial evoked response. In the former case, the joint coupling quality score will not be directly reduced to an excessively low level due to a single interface fluctuation. In the latter case, the joint coupling quality score can continue to decrease as the evoked response change continues to decrease. Through the above correction process, the joint coupling quality score reflects both the degree of deviation between the reference coupling state and the multi-source coupling observation data, as well as the actual impact of the deviation on the target tissue response result, thus providing a unified judgment basis for subsequent performance of limited compensation and determination of mismatch status.

[0141] When the joint coupling quality score decreases relative to the joint coupling quality score at the previous acquisition time, and the changes in the induced response in the multi-source coupled observation data indicate that the current response result is lower than the initial induced response in the reference coupling state, limited compensation is performed based on the reference coupling state.

[0142] Methods for implementing limited compensation include:

[0143] The initial output parameters in the reference coupling state are read, and compensation adjustment results are generated based on the acoustic coupling attenuation index and the electrical contact drift index. The compensation adjustment results include ultrasonic intensity adjustment results, duty cycle adjustment results, current adjustment results, and pulse width adjustment results. Limited compensation is performed based on the initial output parameters and the compensation adjustment results.

[0144] In some embodiments, the method for reading the initial output parameters in the reference coupling state and generating compensation adjustment results based on the acoustic coupling attenuation index and the electrical contact drift index includes: reading the initial output parameters in the reference coupling state, the initial output parameters including initial ultrasonic intensity, initial duty cycle, initial current, and initial pulse width; then reading the current acoustic coupling attenuation index, current electrical contact drift index, interface temperature rise, and initial interface temperature rise; when the current acoustic coupling attenuation index is higher than the minimum value and the interface temperature rise is not higher than the initial interface temperature rise, it is determined that compensation adjustment of the ultrasonic intensity and duty cycle is required; when the current acoustic coupling attenuation index remains at the minimum value, it is determined that the ultrasonic intensity adjustment result and the duty cycle adjustment result are to keep the initial output parameters unchanged. When the interface temperature rises above the initial interface temperature rise, the treatment device does not continue to read the compensation level arranged after the current corresponding compensation level according to the higher candidate value corresponding to the current acoustic coupling attenuation index; the treatment device first reads the current corresponding compensation level that should correspond to the current acoustic coupling attenuation index when the interface temperature rise is not higher than the initial interface temperature rise; when the current corresponding compensation level is not the lowest compensation level, it reads the compensation level arranged one position before the current corresponding compensation level, and determines the read compensation level as the ultrasound intensity adjustment result and duty cycle adjustment result respectively; when the current corresponding compensation level is the lowest compensation level, it keeps the lowest compensation level unchanged, and determines the lowest compensation level as the ultrasound intensity adjustment result and duty cycle adjustment result respectively.

[0145] The premise for reading from the current corresponding compensation level to the previous lower compensation level is that the current corresponding compensation level is not the lowest compensation level. When the current corresponding compensation level is already the lowest compensation level, the current lowest compensation level is kept unchanged. When the current electrical contact drift index is higher than the minimum value, it is determined that the current and pulse width need to be compensated and adjusted. When the current electrical contact drift index remains at the minimum value, it is determined that the current adjustment result and pulse width adjustment result are to keep the initial output parameters unchanged. When it is determined that compensation adjustment is needed, according to the candidate value order corresponding to the acoustic coupling attenuation index or electrical contact drift index, multiple adjustment levels corresponding to the candidate values ​​are pre-set for the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width. The method for setting multiple adjustment levels is to set multiple compensation levels from small to large for each output parameter based on the initial output parameters of the initial induced response obtained under the reference coupling state and in combination with the output range that the device allows to continue treatment.

[0146] The later the candidate value, the later the corresponding compensation level. After reading the current acoustic coupling attenuation index or the current electrical contact drift index, the adjustment level corresponding to the current candidate value is directly read from the corresponding adjustment level, and the read adjustment level is determined as the ultrasonic intensity adjustment result, duty cycle adjustment result, current adjustment result, and pulse width adjustment result, respectively. The ultrasonic intensity adjustment result and duty cycle adjustment result are also limited by whether the interface temperature rise is higher than the initial interface temperature rise. When the interface temperature rise is higher than the initial interface temperature rise, the ultrasonic intensity adjustment result and duty cycle adjustment result must not read the ultrasonic intensity compensation level and duty cycle compensation level that are arranged after the current corresponding compensation level in the preset compensation level order. By determining the compensation adjustment result in the above way, the compensation adjustment result has a clear generation basis and reading method, and is consistent with the safety limit corresponding to the interface thermal response.

[0147] In some embodiments, the method for performing limited compensation based on initial output parameters and compensation adjustment results includes: reading initial output parameters and compensation adjustment results; adjusting the initial ultrasound intensity according to the ultrasound intensity adjustment results to obtain the compensated ultrasound intensity; adjusting the initial duty cycle according to the duty cycle adjustment results to obtain the compensated duty cycle; adjusting the initial current according to the current adjustment results to obtain the compensated current; adjusting the initial pulse width according to the pulse width adjustment results to obtain the compensated pulse width; writing the compensated ultrasound intensity, compensated duty cycle, compensated current, and compensated pulse width into the current output settings of the treatment device, and continuing to perform treatment output according to the written current output settings.

[0148] The "limited" aspect of the limited compensation refers to the fact that the compensated ultrasound intensity, compensated duty cycle, compensated current, and compensated pulse width must not exceed the output range allowed for continued treatment by the equipment. When the adjustment level corresponding to the compensation result causes any output parameter to exceed the output range allowed for continued treatment by the equipment, the corresponding output parameter will be kept within the boundary of the output range allowed for continued treatment by the equipment, and the result after keeping it will be used as the final compensation result for the corresponding output parameter. In this way, the limited compensation can adjust the output according to the current deviation, and also ensure that the adjusted output is still within the range allowed for continued treatment.

[0149] Methods for implementing limited compensation also include:

[0150] A contact recovery command is generated based on multi-source coupled observation data. After the contact recovery command is output, multi-source coupled observation data is reacquired. If the induced response change obtained by reacquisition still indicates that the current response result is lower than the initial induced response, then limited compensation is performed based on the initial output parameters and compensation adjustment results.

[0151] Methods for generating contact recovery instructions include:

[0152] Based on the deviations of the interface temperature rise and the difference in coupling layer thickness from the reference coupling state, a coupling medium replenishment command or a probe clamping correction command is generated; based on the deviations of the electrode contact impedance and the local motion state from the reference coupling state, an electrode reattachment command or a strap pressure adjustment command is generated; the contact recovery command includes a coupling medium replenishment command, a probe clamping correction command, an electrode reattachment command, and a strap pressure adjustment command.

[0153] The initial electrode contact impedance is the initial conductive impedance formed after the electrode contacts the skin before treatment. The initial electrode contact impedance is used to characterize the initial contact conditions of the electrical stimulation path. When acquiring the initial electrode contact impedance, a detection current is output from the electrical stimulation channel before the formal treatment output, and the corresponding voltage response is acquired at the same time. The impedance result between the electrode and the skin is obtained based on the detection current and the corresponding voltage response. The impedance result obtained through the first contact detection is determined as the initial electrode contact impedance. After determining the impedance result obtained through the first contact detection as the initial electrode contact impedance, in order to form the natural fluctuation range corresponding to the initial electrode contact impedance, under the conditions that the probe position is not adjusted, the electrode position is not adjusted, the human body is kept in the pre-treatment preparation state, and the formal treatment output has not yet started, the same detection current, the same acquisition path, and the same acquisition sequence as the first contact detection are continued.

[0154] For example, the impedance results between the electrode and the skin are continuously collected nine times, thus forming ten consecutive collection results together with the impedance results obtained from the first contact detection. A fixed time interval is maintained between two adjacent collections of the ten consecutive collection results, which is set to 0.5 seconds, and the total duration is set to five seconds. During the ten consecutive collections, if the local motion state corresponding to any collection changes in position or posture relative to the previous collection, or if the electrode edge lifts up, the voltage response is interrupted, or the detection current is not fully output, the corresponding collection result is determined as an abnormal collection result and deleted.

[0155] After deleting abnormal acquisition results, re-acquisitions are performed under the same pre-treatment preparation state until ten valid acquisition results are retained. After obtaining ten valid acquisition results, the ten valid acquisition results are continuously compared in the acquisition order. When a certain acquisition result is higher than both the previous acquisition result and the next acquisition result, and the corresponding difference exceeds the other differences between the two adjacent acquisitions, the corresponding acquisition result is determined to be a noise acquisition result. When a certain acquisition result is lower than both the previous acquisition result and the next acquisition result, and the corresponding difference exceeds the other differences between the two adjacent acquisitions, the corresponding acquisition result is also determined to be a noise acquisition result.

[0156] For example, after obtaining ten valid acquisition results, noise judgment is performed only on intermediate acquisition results other than the first and last acquisition results; for any intermediate acquisition result x_i, the treatment device determines the noise acquisition result as follows:

[0157] ;

[0158] ;

[0159] ;

[0160] ;

[0161] Where i represents the sequence number of the intermediate acquisition result, and ; This represents the result of the i-th valid data collection. This represents the difference between the i-th valid acquisition result and the previous acquisition result; This represents the difference between the i-th valid acquisition result and the subsequent acquisition result; This represents the upper limit of the noise difference corresponding to the i-th valid acquisition result; This indicates that the i-th valid acquisition result is a noise acquisition result; This indicates that the i-th valid acquisition result is not a noise acquisition result; Except for the same set of valid collection results and The difference between the two adjacent data collections, excluding those from the previous two data collections, is obtained.

[0162] After deleting the noise acquisition results, continue to acquire data under the same pre-treatment preparation state until ten valid acquisition results are obtained again. After retaining the ten valid acquisition results, read the maximum and minimum values ​​of the ten valid acquisition results, and determine the interval between the maximum and minimum values ​​as the natural fluctuation range corresponding to the initial electrode contact impedance. When judging whether the electrode contact impedance deviates from the reference coupling state, the natural fluctuation range corresponding to the initial electrode contact impedance is used as the basis for comparison.

[0163] The initial evoked response is the initial response result generated by the target tissue and detected by the treatment device after the initial output parameters are applied to the target tissue. The initial evoked response is used to characterize the initial effect after the effective stimulus has been transmitted to the target tissue under the reference coupling state. When collecting the initial evoked response, after the probe and electrode are attached, a short trial output is performed according to the initial output parameters, and the response signal corresponding to the target tissue is collected simultaneously. The method of collecting the response signal is as follows: first, before the treatment starts, the response signal type, detection site, detection window and characteristic amplitude value method used in the same treatment process are determined. Then, the response signal is continuously collected at the fixed detection site, and the characteristic amplitude is read in the detection window. The characteristic amplitude that first meets the treatment initiation conditions is determined as the initial evoked response.

[0164] For example, after determining the characteristic amplitude that first meets the treatment initiation conditions as the initial evoked response, in order to form the natural fluctuation range corresponding to the initial evoked response, under the conditions that the reference coupling state remains unchanged, the initial output parameters remain unchanged, the detection site remains unchanged, the detection window remains unchanged, and the human body remains in the pre-treatment preparation state, nine short-term trial outputs are performed with the same initial output parameters, and the response signal is collected within the detection window corresponding to each short-term trial output, thereby forming ten consecutive acquisition results together with the characteristic amplitude that first meets the treatment initiation conditions; a fixed time interval is maintained between two adjacent acquisitions of the ten consecutive acquisition results, the fixed time interval is set to 0.5 seconds, and the total duration is set to... The interval is five seconds. During ten consecutive acquisitions, the current displacement change result and the current attitude change result within the corresponding acquisition time period are read first. Then, the maximum value of the current displacement change is read from the current displacement change result and the maximum value of the current attitude change is read from the current attitude change result. When the maximum value of the current displacement change exceeds the natural fluctuation range corresponding to the maximum displacement change, or the maximum value of the current attitude change exceeds the natural fluctuation range corresponding to the maximum attitude change, or when there is an interruption in the response signal, displacement of the detection part, adjustment of the probe position, adjustment of the electrode position, or the current output is not fully executed according to the initial output parameters, the corresponding acquisition result is determined as an abnormal acquisition result and deleted.

[0165] After deleting abnormal acquisition results, re-acquisitions were performed under the same pre-treatment preparation state until ten valid acquisition results were retained. After obtaining ten valid acquisition results, the ten valid acquisition results were continuously compared in the acquisition order. When a certain acquisition result is higher than both the previous and subsequent acquisition results, and the corresponding difference exceeds the other differences between the two adjacent acquisitions, the corresponding acquisition result is identified as a noise acquisition result. When a certain acquisition result is lower than both the previous and subsequent acquisition results, and the corresponding difference exceeds the other differences between the two adjacent acquisitions, the corresponding acquisition result is also identified as a noise acquisition result. After deleting the noise acquisition results, re-acquisitions were performed under the same pre-treatment preparation state until ten valid acquisition results were obtained again. After retaining the ten valid acquisition results, the maximum and minimum values ​​of the ten valid acquisition results were read, and the interval between the maximum and minimum values ​​was determined as the natural fluctuation range corresponding to the initial evoked response. Subsequent judgments on whether the changes in the evoked response are still within the natural fluctuation range corresponding to the initial evoked response are all based on the natural fluctuation range corresponding to the initial evoked response.

[0166] It should be noted that the coupling medium replenishment command is a supplementary prompt output by the treatment device after detecting a deviation in the interface temperature rise and the difference in coupling layer thickness relative to the reference coupling state. The coupling medium replenishment command is used to prompt the replenishment of coupling medium between the probe and the action site so that the thickness of the coupling medium between the probe and the action site is restored to a state close to the initial coupling layer thickness. The probe clamping correction command is an adhesion correction prompt output by the treatment device after detecting a deviation in the interface temperature rise and the difference in coupling layer thickness relative to the reference coupling state. The probe clamping correction command is used to prompt the readjustment of the adhesion force between the probe and the action site so that the probe contact state is restored to an adhesion state close to the reference coupling state.

[0167] In some embodiments, the method for determining whether the electrode contact impedance and local motion state deviate from the reference coupling state includes: reading the initial electrode contact impedance and initial local motion state in the reference coupling state, and then reading the electrode contact impedance and local motion state in the multi-source coupling observation data; when determining whether the electrode contact impedance has deviated, comparing the electrode contact impedance with the natural fluctuation range corresponding to the initial electrode contact impedance; when the electrode contact impedance exceeds the natural fluctuation range corresponding to the initial electrode contact impedance, determining that the electrode contact impedance has deviated from the reference coupling state; when the electrode contact impedance does not exceed the natural fluctuation range corresponding to the initial electrode contact impedance, determining that the electrode contact impedance has not deviated from the reference coupling state.

[0168] To determine whether a local motion state has deviated, the maximum value of the current displacement change and the maximum value of the current attitude change are first read from the local motion state. Then, the maximum value of the current displacement change is compared with the natural fluctuation range corresponding to the maximum displacement change, and the maximum value of the current attitude change is compared with the natural fluctuation range corresponding to the maximum attitude change. When the maximum value of the current displacement change falls within the natural fluctuation range corresponding to the maximum displacement change, and the maximum value of the current attitude change falls within the natural fluctuation range corresponding to the maximum attitude change, it is determined that the local motion state has not deviated from the reference coupling state. When the maximum value of the current displacement change exceeds the natural fluctuation range corresponding to the maximum displacement change, or the maximum value of the current attitude change exceeds the natural fluctuation range corresponding to the maximum attitude change, it is determined that the local motion state has deviated from the reference coupling state. Based on the electrode contact impedance and the deviation of the local motion state from the reference coupling state, an electrode re-attachment command or a strap pressure adjustment command is generated.

[0169] The natural fluctuation range corresponding to the initial electrode contact impedance is determined by continuously acquiring the electrode contact impedance multiple times under the reference coupling state and using the interval between the maximum and minimum values ​​in the continuous acquisition results. The natural fluctuation range corresponding to the maximum displacement change is determined by continuously acquiring the maximum displacement change multiple times under the reference coupling state and using the interval between the maximum and minimum values ​​in the continuous acquisition results. The natural fluctuation range corresponding to the maximum attitude change is determined by continuously acquiring the maximum attitude change multiple times under the reference coupling state and using the interval between the maximum and minimum values ​​in the continuous acquisition results.

[0170] It should be noted that the electrode reattachment command is a prompt output by the treatment device after detecting a deviation in electrode contact impedance and local motion state from the reference coupling state. The electrode reattachment command is used to prompt the electrode to be removed from its current position and reattached to the vicinity of its original target position so that the contact state between the electrode and the skin is restored to a state close to the reference coupling state. The bandage pressure adjustment command is a fixation correction prompt output by the treatment device after detecting a deviation in electrode contact impedance and local motion state from the reference coupling state. The bandage pressure adjustment command is used to prompt the tightness of the bandages fixing the electrode or probe to be readjusted so that the electrode and probe remain fixed in a state close to the reference coupling state during treatment.

[0171] By implementing constrained compensation, when the combined coupling quality score decreases relative to the previous acquisition time and the evoked response changes indicate that the current response result is lower than the initial evoked response, the current treatment output can be adjusted based on the initial output parameters of the initial evoked response already formed under the reference coupling state. Simultaneously, by first generating a contact recovery command, then re-acquiring multi-source coupling observation data, and continuing to implement constrained compensation when the evoked response changes still indicate that the current response result is lower than the initial evoked response, contact condition recovery and output compensation can be combined. This avoids directly and continuously increasing the treatment output when interface deviation can still be recovered through attachment correction. Therefore, constrained compensation can both increase the likelihood of the effective stimulus recovering to a state close to the initial evoked response during the current treatment process and ensure that the compensation process is always constrained by the reference coupling state and the output range allowed by the device to continue treatment, thereby improving the targeted nature of compensation and the safety of treatment for combined acoustic and electrical therapy.

[0172] If, after implementing limited compensation, the induced response change still indicates that the current response result is lower than the initial induced response, it is determined to be a mismatch state and treatment is terminated or downgraded.

[0173] Methods for determining a mismatch include:

[0174] After performing constrained compensation, the joint coupling quality score is recalculated. When the recalculated joint coupling quality score decreases compared to the most recently calculated joint coupling quality score before performing constrained compensation, and the changes in the induced response at at least two adjacent acquisition times indicate that the current response result is lower than the initial induced response, it is determined to be a mismatch state.

[0175] A mismatch is identified when the recalculated joint coupling quality score decreases compared to the most recently calculated joint coupling quality score before the implementation of constrained compensation, and the changes in induced responses at at least two adjacent acquisition times indicate that the current response result is lower than the initial induced response. The reasons are as follows: The continued decrease in the recalculated joint coupling quality score after constrained compensation indicates that the deviation between the reference coupling state and the current multi-source coupling observation data has not been reduced by constrained compensation, but rather continues to decline after compensation; the changes in induced responses at at least two adjacent acquisition times indicate that the current response result is lower than the initial induced response, indicating that the current response result corresponding to the target tissue is not only lower than the initial induced response at a single acquisition time, but has not recovered to the level corresponding to the initial induced response at two consecutive acquisition times. Using the continued decrease in the recalculated joint coupling quality score and the changes in induced responses at at least two adjacent acquisition times indicating that the current response result is lower than the initial induced response as the combined criteria, it can be determined that the current treatment process simultaneously suffers from both unrecovered interface transfer conditions and unrecovered target tissue response results. Furthermore, constrained compensation has failed to bring the current treatment state back to the treatment basis corresponding to the reference coupling state. Therefore, the current treatment process can be identified as entering a mismatch state.

[0176] Termination or downgrade of treatment specifically refers to:

[0177] When the interface temperature rise corresponding to the mismatch state exceeds the initial interface temperature rise, a treatment termination command is output; when the interface temperature rise corresponding to the mismatch state is not higher than the initial interface temperature rise, a treatment downgrade command is output, and treatment continues according to the downgrade output parameters, which include ultrasound intensity, duty cycle, current, and pulse width that are lower than the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width, respectively.

[0178] In some embodiments, treatment continues according to degraded output parameters, wherein the degraded output parameters include ultrasound intensity, duty cycle, current, and pulse width that are respectively lower than the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width. The method includes: reading the initial output parameters in a reference coupling state, the initial output parameters including initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width; and then setting multiple treatment continuity levels in the treatment device, arranged in descending order of value, for the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width; the method for setting the multiple treatment continuity levels is based on the initial ultrasound intensity, initial duty cycle, initial current, initial pulse width, initial current ... The initial current and initial pulse width are used as the starting levels for the corresponding parameters. Then, based on the lower limit of the output allowed for continued treatment by the device, the first, second, and third levels of continued treatment are set for each output parameter in a fixed decreasing order. The first level of continued treatment is lower than the corresponding initial output parameter, the second level of continued treatment is lower than the first level of continued treatment, the third level of continued treatment is lower than the second level of continued treatment, and the third level of continued treatment is not lower than the lower limit of the output allowed for continued treatment by the device. Through the above settings, the output parameters that are lower than the initial output parameters have a clear range of reduction and a minimum lower limit.

[0179] After outputting the downgrade treatment command, the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width are reduced simultaneously. Specifically, the first continuing treatment level corresponding to the initial ultrasound intensity, the first continuing treatment level corresponding to the initial duty cycle, the first continuing treatment level corresponding to the initial current, and the first continuing treatment level corresponding to the initial pulse width are read respectively, and the aforementioned four first continuing treatment levels are written into the current output settings of the treatment device. Then, treatment continues according to the written current output settings. The reason for reducing the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width simultaneously is that the mismatch state indicates that the acoustic transmission interface and electrical stimulation contact interface in the current treatment process have failed to recover to the treatment basis corresponding to the reference coupling state through limited compensation. Therefore, when continuing treatment, instead of reducing only a single output parameter, the ultrasound output and electrical stimulation output are reduced at the same level simultaneously so that the overall output level in the continuing treatment process is lower than the overall output level corresponding to the initial output parameter.

[0180] After continuing treatment at the first treatment level, multi-source coupling observation data are re-acquired at the end of a detection window, and the changes in evoked response, co-coupling mass fraction, and interface temperature rise are reassessed. If the re-acquired changes in evoked response do not continue to be lower than the initial evoked response, or the co-coupling mass fraction does not continue to decrease, the current first treatment level is maintained, and treatment continues at the current first treatment level. If the re-acquired changes in evoked response still indicate that the current response result is lower than the initial evoked response, and the co-coupling mass fraction continues to decrease, while the interface temperature rise is still not higher than the initial interface temperature rise, the initial ultrasound intensity and initial occupancy are adjusted. The initial duty cycle, initial current, and initial pulse width are simultaneously adjusted from the first treatment level to the second treatment level, and treatment continues according to the second treatment level. After treatment continues according to the second treatment level, multi-source coupling observation data are re-acquired at the end of the next detection window. If the re-acquired induced response changes still indicate that the current response result is lower than the initial induced response, the joint coupling mass fraction continues to decrease, and the interface temperature rise is still not higher than the initial interface temperature rise, then the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width are simultaneously adjusted from the second treatment level to the third treatment level, and treatment continues according to the third treatment level.

[0181] By fixing the reassessment point at the end of each testing window and fixing the descent order as a synchronous descent from the first continuing treatment level to the second continuing treatment level and then to the third continuing treatment level, the continuing treatment process after downgrading has a clear execution sequence and a basis for reassessment.

[0182] When the current output setting has dropped to the third level of continued treatment, and the changes in the induced response obtained after the detection window corresponding to the third level of continued treatment ends still indicate that the current response result is lower than the initial induced response, the joint coupling mass fraction continues to decrease, or the interface temperature rise turns to be higher than the initial interface temperature rise, the output parameters will no longer be reduced, but a treatment termination command will be output.

[0183] The treatment termination command is a control result output by the treatment device to stop the current ultrasound output and electrical stimulation output after a mismatch is determined. After the treatment termination command is output, the treatment device stops the continuous output of the current treatment channel and retains the reference coupling state, multi-source coupling observation data, joint coupling quality fraction, and interface temperature rise corresponding to the mismatch state for subsequent reattachment, reassessment, or state confirmation before restarting treatment. The treatment downgrade command is a control result output by the treatment device to reduce the current treatment output level and continue treatment after a mismatch is determined. After the treatment downgrade command is output, the treatment device no longer uses the current output settings after performing limited compensation, but rereads the initial output parameters in the reference coupling state and adjusts the ultrasound intensity, duty cycle, current, and pulse width to output parameters lower than the initial output parameters before continuing treatment.

[0184] The method for determining the downgraded output parameters is as follows: the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width are used as comparison benchmarks for continued treatment, and the first continued treatment level corresponding to the initial ultrasound intensity, the first continued treatment level corresponding to the initial duty cycle, the first continued treatment level corresponding to the initial current, and the first continued treatment level corresponding to the initial pulse width are read respectively; the treatment device uses the read ultrasound intensity, duty cycle, current, and pulse width together to determine the downgraded output parameters, and continues to output with the downgraded output parameters.

[0185] When the interface temperature corresponding to the mismatch state rises above the initial interface temperature rise, a treatment termination command is output. The specific reason is as follows: the mismatch state indicates that the coupling conditions in the current treatment process have not been restored, and the limited compensation has not restored the induced response change to the level corresponding to the initial induced response. On this basis, if the interface temperature corresponding to the mismatch state rises above the initial interface temperature rise, it means that the current interface thermal response is already higher than the initial thermal response under the reference coupling state. At this time, continuing to maintain the treatment output, whether continuing to maintain the current output setting after the limited compensation or continuing to execute new compensation, cannot change the fact that the current treatment is already in a mismatch state. On the contrary, it will cause the interface to continue to bear the treatment output. Therefore, when the interface temperature corresponding to the mismatch state rises above the initial interface temperature rise, the treatment termination command is output. This can stop the current treatment output first, and then process the probe attachment state, electrode attachment state, and coupling medium state, thereby avoiding continued output under the mismatch state.

[0186] When the interface temperature rise corresponding to the mismatch state is not higher than the initial interface temperature rise, a downgraded treatment instruction is output, and treatment continues according to the downgraded output parameters. These downgraded output parameters include ultrasound intensity, duty cycle, current, and pulse width that are lower than the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width, respectively. The specific reason is that the mismatch state indicates that the current limited compensation has not restored the combined coupling mass fraction and induced response changes to the levels corresponding to the reference coupling state. However, the interface temperature rise corresponding to the mismatch state is not higher than the initial interface temperature rise, indicating that the current interface thermal response has not exceeded the initial thermal response under the reference coupling state. In this case, although the current treatment process is not suitable to continue according to the initial output... The current output settings after parameter or performance limitation compensation are maintained, but the interface burden can still be reduced by lowering the output level, and multi-source coupling observation data and induced response changes can continue to be observed under lower output conditions. Therefore, when the interface temperature rise corresponding to the mismatch state is not higher than the initial interface temperature rise, a downgraded treatment command is output, and treatment continues according to the downgraded output parameters. The downgraded output parameters include ultrasound intensity, duty cycle, current, and pulse width that are lower than the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width, respectively. This allows the current treatment process to be retained without using higher output settings, thus providing a basis for continued observation and reassessment of subsequent treatment control.

[0187] By determining the mismatch state, it is possible to clearly distinguish whether the current treatment process has deviated from the effective treatment basis corresponding to the reference coupling state after performing limited compensation. When the recalculated joint coupling quality score decreases compared to the most recently calculated joint coupling quality score before performing limited compensation, and the changes in the induced response corresponding to at least two adjacent acquisition times indicate that the current response result is lower than the initial induced response, the treatment device no longer considers the current state as a state that can be recovered through general compensation, but directly switches to the control flow corresponding to the mismatch state. Based on this, and combined with the comparison results between the interface temperature rise corresponding to the mismatch state and the initial interface temperature rise, a choice is made between the treatment termination command and the treatment downgrade command. This allows the subsequent processing for combined acoustic and electrical therapy to take into account both the induced response recovery and the interface thermal response, thereby improving the targeting of the processing after the mismatch state determination and the safety of the treatment.

[0188] Example 2:

[0189] like Figure 2 As shown, this embodiment provides a coupling quality assessment and dose compensation system for combined acoustic and electrical therapy, including:

[0190] The first acquisition module is used to acquire a reference coupling state before treatment.

[0191] The second acquisition module is used to continuously acquire multi-source coupled observation data during the treatment process.

[0192] The index calculation module is used to calculate the acoustic coupling attenuation index and the electrical contact drift index based on the reference coupling state and multi-source coupling observation data; and to calculate the joint coupling quality score based on the acoustic coupling attenuation index and the electrical contact drift index.

[0193] The compensation execution module is used to perform limited compensation based on the reference coupling state when the joint coupling quality score decreases relative to the joint coupling quality score at the previous acquisition time, and the changes in the induced response in the multi-source coupled observation data indicate that the current response result is lower than the initial induced response in the reference coupling state.

[0194] The status determination module is used to determine a mismatch state and terminate or downgrade treatment when the induced response change after limited compensation still indicates that the current response result is lower than the initial induced response.

[0195] In summary, this application establishes a reference coupling state before treatment, continuously collects multi-source coupling observation data during treatment, and calculates the acoustic coupling attenuation index, electrical contact drift index, and joint coupling quality score based on the reference coupling state and multi-source coupling observation data. This enables a joint assessment of the ultrasound transmission interface state, electrical stimulation contact state, and evoked response results during combined acoustic-electric therapy. When the joint coupling quality score decreases and the evoked response changes below the initial evoked response, restricted compensation is performed based on the reference coupling state. After restricted compensation, the reassessment results are combined to determine whether a mismatch state has been entered and whether treatment should be terminated or downgraded. This improves the accuracy of coupling quality assessment, the specificity of dose compensation, and the safety of the treatment process in combined acoustic-electric therapy.

[0196] The above description is merely a preferred embodiment of this application. The scope of protection of this application is not limited to the above embodiments. All technical solutions falling within the scope of this application's concept are within the scope of protection of this application. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of this application should also be considered within the scope of protection of this application.

Claims

1. A method for coupling quality assessment and dose compensation in combined acoustic and electrotherapy, characterized in that, include: A reference coupling state was obtained before treatment; Multi-source coupled observation data were continuously collected during the treatment process; The acoustic coupling attenuation index and electrical contact drift index were calculated based on the reference coupling state and multi-source coupling observation data. The joint coupling mass fraction was calculated based on the acoustic coupling attenuation index and the electrical contact drift index. When the joint coupling quality score decreases relative to the joint coupling quality score at the previous acquisition time, and the changes in the induced response in the multi-source coupled observation data indicate that the current response result is lower than the initial induced response in the reference coupling state, limited compensation is performed based on the reference coupling state. If, after implementing limited compensation, the induced response change still indicates that the current response result is lower than the initial induced response, it is determined to be a mismatch state and treatment is terminated or downgraded.

2. The method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy according to claim 1, characterized in that, Methods for calculating the acoustic coupling attenuation index include: Read the initial ultrasonic reflection echo characteristics, initial interface temperature rise, and initial coupling layer thickness in the reference coupling state; Read the ultrasonic reflection echo characteristics, interface temperature rise, and coupling layer thickness difference from the multi-source coupled observation data, and determine the reflection deviation, temperature rise deviation, and thickness deviation results, respectively. The acoustic coupling attenuation index is calculated based on the reflection deviation, temperature rise deviation, and thickness deviation results.

3. The method for coupling quality assessment and dose compensation in combined acoustic and electrotherapy according to claim 1, characterized in that, Methods for calculating the electrical contact drift index include: Read the initial electrode contact impedance and initial local motion state in the reference coupling state; Read the changes in electrode contact impedance, local motion state, and induced response from the multi-source coupled observation data, and determine the impedance deviation, motion deviation, and response deviation results, respectively. The electrical contact drift index is calculated based on the impedance deviation, motion deviation, and response deviation results.

4. The method for coupling quality assessment and dose compensation in combined acoustic and electrotherapy according to claim 1, characterized in that, Methods for calculating the joint coupling quality score include: Acoustic component quality values ​​are generated based on the acoustic coupling attenuation index; The electrical contact sub-quality values ​​are generated based on the electrical contact drift index; The acoustic sub-quality values ​​and the electrical contact sub-quality values ​​are compared on the same score scale, and the sub-quality value with the smaller value is determined as the base quality value. The baseline mass value is corrected by incorporating the deviation of the induced response from the initial induced response, resulting in the joint coupling mass score.

5. The method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy according to claim 1, characterized in that, Methods for implementing limited compensation include: Read the initial output parameters in the reference coupling state, and generate compensation and adjustment results based on the acoustic coupling attenuation index and the electrical contact drift index; Limited compensation is performed based on the initial output parameters and the compensation adjustment results.

6. The method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy according to claim 5, characterized in that, Methods for implementing limited compensation also include: Before performing limited compensation based on the initial output parameters and compensation adjustment results, a contact recovery command is generated based on the multi-source coupled observation data. After the contact recovery command is output, the multi-source coupled observation data is reacquired. If the changes in the induced response obtained from the re-acquisition still indicate that the current response result is lower than the initial induced response, then limited compensation is performed based on the initial output parameters and the compensation adjustment results.

7. The method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy according to claim 6, characterized in that, Methods for generating contact recovery instructions include: When the difference in coupling layer thickness exceeds the natural fluctuation range corresponding to the difference in coupling layer thickness, and the interface temperature rise is not higher than the initial interface temperature rise, a coupling medium replenishment command is generated. When the difference in coupling layer thickness exceeds the natural fluctuation range corresponding to the difference in coupling layer thickness, and the interface temperature rises above the initial interface temperature rise, a probe clamping correction command is generated. When the electrode contact impedance exceeds the natural fluctuation range corresponding to the initial electrode contact impedance, an electrode reattachment command is generated. When the maximum value of the current displacement change in the local motion state exceeds the natural fluctuation range corresponding to the maximum displacement change, or when the maximum value of the current attitude change exceeds the natural fluctuation range corresponding to the maximum attitude change, a strap pressure adjustment command is generated. Contact restoration commands include coupling medium replenishment commands, probe clamping correction commands, electrode reattachment commands, and strap pressure adjustment commands.

8. The method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy according to claim 6, characterized in that, Methods for determining a mismatch include: After performing the restricted compensation, the joint coupling quality score is recalculated; When the recalculated joint coupling quality score decreases compared to the most recently calculated joint coupling quality score before the execution of constrained compensation, and the changes in the induced response at at least two adjacent acquisition times indicate that the current response result is lower than the initial induced response, it is determined to be a mismatch state.

9. The method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy according to claim 8, characterized in that, Termination or downgrade of treatment specifically refers to: When the interface temperature rise in the multi-source coupled observation data corresponding to the mismatch state exceeds the initial interface temperature rise in the reference coupled state, a treatment termination command is output. When the interface temperature rise in the multi-source coupling observation data corresponding to the mismatch state is not higher than the initial interface temperature rise in the reference coupling state, a downgrade treatment command is output, and treatment continues according to the downgrade output parameters. The downgrade output parameters include ultrasound intensity, duty cycle, current, and pulse width that are lower than the initial ultrasound intensity, initial duty cycle, initial current, and initial pulse width, respectively.

10. The method for coupling quality assessment and dose compensation in combined acoustic and electrical therapy according to claim 5, characterized in that, When the interface temperature rise in the multi-source coupled observation data is higher than the initial interface temperature rise in the reference coupling state, the ultrasonic intensity adjustment result and duty cycle adjustment result in the compensation adjustment result will not read the ultrasonic intensity compensation level and duty cycle compensation level that are arranged after the current corresponding compensation level in the preset compensation level order.

11. A coupling quality assessment and dose compensation system for combined acoustic and electrotherapy, used to implement the coupling quality assessment and dose compensation method for combined acoustic and electrotherapy as described in any one of claims 1-10, characterized in that, include: The first acquisition module is used to acquire a reference coupling state before treatment. The second acquisition module is used to continuously acquire multi-source coupled observation data during the treatment process; The index calculation module is used to calculate the acoustic coupling attenuation index and the electrical contact drift index based on the reference coupling state and multi-source coupling observation data; The joint coupling mass fraction was calculated based on the acoustic coupling attenuation index and the electrical contact drift index. The compensation execution module is used to perform limited compensation based on the reference coupling state when the joint coupling quality score decreases relative to the joint coupling quality score at the previous acquisition time, and the changes in the induced response in the multi-source coupled observation data indicate that the current response result is lower than the initial induced response in the reference coupling state. The status determination module is used to determine a mismatch state and terminate or downgrade treatment when the induced response change after limited compensation still indicates that the current response result is lower than the initial induced response.