System and method for evaluating and controlling curative effect of electro-therapeutic apparatus

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a curative effect evaluation and control system and method of an electro-therapeutic apparatus. The system comprises a power supply unit, an electrode assembly and a main control unit, as well as a man-machine interaction assembly, an electric pulse signal generation module, a physiological electrical parameter acquisition unit and a signal switching unit which are electrically connected with the main control unit, the electric pulse signal generation module and the physiological electrical parameter acquisition unit are electrically connected with the electrode assembly through the signal switching unit. A curative effect evaluation operation program and a project service program supporting electric treatment, electroporation and iontophoresis medicine guiding are operated in the main control unit, and deep analysis and comprehensive evaluation of human body physiological parameters collected in different working modes are supported. Therefore, according to the technical scheme, the electrotherapy, electroporation and iontophoresis drug guiding effects can be accurately quantified, deep evaluation is carried out according to multi-mode data, a scientific basis is provided for personalized treatment, and the technical scheme has important significance on improvement of treatment accuracy and effectiveness.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a therapeutic effect evaluation and control system and method of an electrotherapy device. Background Art

[0002] Direct current / low-medium frequency electrotherapy is widely used in clinical treatment. It applies electrical stimulation signals by means of electrodes in contact with the human body, generating electric current in human tissues, thereby achieving various effects such as analgesia, anti-inflammation, elimination of edema, accelerated microcirculation, promotion of wound healing, assistance in muscle recovery, and strengthening of muscles. Ion electrophoresis drug delivery technology relies on specific currents to promote the transport of drugs across biological barriers and increase the amount of drug penetration to achieve the purpose of drug introduction. Some of the related instruments on the market currently have both electrical treatment and drug introduction functions, while others only have a single function. Common names include medium frequency therapeutic devices, low frequency therapeutic devices, ion permeation devices, and transdermal drug delivery therapeutic devices.

[0003] However, the existing electrotherapy devices have many shortcomings. On the one hand, electrotherapy devices are usually equipped with a variety of treatment prescriptions, but in actual applications, doctors often choose blindly based on experience, and it is difficult to know the actual treatment effect of the selected prescription. After each treatment, the treatment effect can only be judged based on the patient's self-reported subjective feelings and other clinical manifestations, and it is impossible to directly and immediately evaluate the efficacy of the current treatment. On the other hand, in the field of transdermal drug delivery, physical barriers such as human skin, cornea and mucous membranes will hinder the entry of drugs into the body across the barriers. For this reason, electroporation technology is often used for pre-treatment before drug introduction, or electroporation function is used alone to introduce drugs in other ways. Although electroporation can use instantaneous high-voltage electric pulses to form reversible aqueous channels or pores to help drug molecules penetrate the barrier, the size of the pores is related to the pore energy. Although high energy can improve the permeability effect, it will increase damage to the tissue. In addition, different drugs have different permeability characteristics and different requirements for pores. Although existing drug delivery instruments with electroporation function can select different gears and energies for pore-forming operations, they are unable to evaluate the pore-forming effect. Whether the electroporation achieves the expected effect can only be inferred with the help of other subsequent clinical manifestations.

[0004] Many academic studies have shown that human physiological electrical parameters, such as impedance (including impedance value, resistance, phase angle and reactance) information, surface electromyography parameters, etc., are significantly correlated with the course of some diseases and the effect of drug introduction. For example, papers such as "Application of human body composition analysis in evaluating the degree and efficacy of lymphedema", "Progress in the application of muscle impedance technology in the evaluation and mechanism of neuromuscular diseases", "Research progress on the characteristics of surface electromyography parameters of lower limbs in patients with knee osteoarthritis and their exercise rehabilitation", and "Effects of electroporation on transdermal drug transport" all reveal such correlations, which means that by measuring human physiological electrical parameters, it can be used to evaluate the therapeutic effect and drug introduction effect. However, these human physiological electrical parameters may be reflected in the electromyographic potential, impedance value, phase value, resistance value or reactance value in the electrical parameters, and not all situations can be reflected in the human physiological electrical parameters. It can be seen that this correlation is quite complex and can only be analyzed based on statistical laws, and it is difficult to accurately quantify.

[0005] In the Chinese patent document "Biological Impedance Detection System, Method and Therapeutic Device" (patent number: CN202410480340.2), the corresponding impedance value of the biological body under the stimulation voltage is measured during treatment and the data is recorded. However, the purpose of the measured data is not explained, and the therapeutic electrical signal is used as the excitation measurement impedance. Due to the nonlinear characteristics of human tissue, the impedance values ​​measured by different excitation signals are different. The impedance data measured using the therapeutic signal as the excitation signal lacks stability and uniformity, and cannot accurately reflect the characteristics of human tissue.

[0006] In the Chinese patent document "A human limb impedance measurement and electrical treatment device" (patent number: CN202410480340.2), the impedance of the human body is measured at multiple points before treatment with the help of a treatment electrode array, and the impedance values ​​before and after treatment are compared according to the theory of traditional Chinese medicine to quantitatively evaluate the treatment effect. In the paper "Electrical Properties of Lumbar Paraspinal Muscles in Young Adults With and Without Chronic Low Back Pain Based on Electrical Impedance Myography: A Cross-Sectional Study" in the SCI journal Front Neurol, an impedance parameter analysis was conducted for the common disease of chronic low back pain, and the complete impedance parameters of the waist muscles of patients and non-patients at multiple different frequency points were compared. The results showed that the patient's impedance value Z and resistance R increased significantly, the phase angle PA decreased, and the reactance X did not change significantly; in the paper "Application of Human Composition Analysis in Assessing the Degree and Efficacy of Lymphedema" in the "Chinese Journal of Rehabilitation Medicine", the author analyzed the relationship between impedance Z and patients, and concluded that the Z value of the affected limb was significantly lower than that of the healthy side. It can be seen that the accuracy of the method is difficult to guarantee if it is based solely on the simple change of impedance values ​​before and after treatment, and the method of judging the therapeutic effect as negative when the impedance value decreases and as positive when the impedance value increases. After all, the human body structure and physiological functions are complex, and medicine itself has limitations. If the disease type is not distinguished, different courses of disease may lead to contradictory conclusions based on this judgment.

[0007] In summary, current electrotherapy devices generally have the problem of being unable to accurately evaluate their effectiveness. Summary of the invention

[0008] The purpose of the present invention is to address the deficiencies in the above-mentioned prior art and propose an efficacy evaluation and control system and method for an electrotherapy instrument, which aims to collect a variety of human electrical parameters by adding a multimodal human physiological electrical parameter acquisition unit, establish a correlation model between the course of various diseases and these electrical parameters with the help of scientific research methods, compare the measured human electrical parameters with the preset model to evaluate the efficacy, and continuously expand the disease-related model data over time so that the instrument can complete the analysis of more diseases, thereby effectively solving the problem of inaccurate effect evaluation of existing electrotherapy instruments.

[0009] The above objectives are achieved specifically through the following technical solutions: A therapeutic effect evaluation and control system for an electrotherapy device includes a power supply unit and a functional operation unit, and the power supply unit is electrically connected to the functional operation unit. The functional operation unit includes a main control unit, a human-machine interaction component, an electrode component, an electric pulse signal generating module, a physiological electrical parameter acquisition unit and a signal switching unit. The physiological electrical parameter acquisition unit is electrically connected to the main control unit, and is electrically connected to the electrode component through the signal switching unit, and is used to cooperate with the electrode component to collect human electrical parameters, and transmit the collected human electrical parameters to the main control unit. The main control unit is electrically connected to the electric pulse signal generating module, and the electrotherapy device control program is run inside it, including obtaining the therapeutic effect evaluation result based on the collected human electrical parameters, and outputting the control signal to the electric pulse signal generating module according to the preset working service program. The electric pulse signal generating module is electrically connected to the physiological electrical parameter acquisition unit, and is electrically connected to the electrode component through the signal switching unit; it is used to output the set working electrical signal to the electrode component according to the control signal output by the main control unit; the physiological electrical parameter acquisition unit collects the working electrical signal in real time, and transmits the relevant data of the working electrical signal to the main control unit for monitoring and controlling the working state of the electric pulse signal generating module. The human-computer interaction component is electrically connected to the main control unit and is used to input electrotherapy information and display patient data including human electrical parameters and efficacy evaluation results.

[0010] Preferably, the physiological electrical parameter acquisition unit includes a type A impedance measurement module, a type B impedance measurement module and a surface electromyography measurement module. The type A impedance measurement module is electrically connected to the main control unit and the electric pulse signal generating module respectively, and is used to obtain the current value and the impedance value according to the working electrical signal and transmit them to the main control unit; the main control unit names the impedance value as type A impedance, and monitors and controls the working state of the electric pulse signal generating module based on the current value and type A impedance. The type B impedance measurement module is electrically connected to the main control unit, and is electrically connected to the electrode assembly through the signal switching unit, and is used to cooperate with the electrode assembly to collect human body impedance parameters and transmit them to the main control unit; the main control unit names the impedance parameters as type B impedance, including impedance value, phase angle, resistance value and reactance value. The surface electromyography measurement module is electrically connected to the main control unit, and is electrically connected to the electrode assembly through the signal switching unit, and is used to cooperate with the electrode assembly to collect human body surface electromyography parameters, and transmit the surface electromyography parameters to the main control unit.

[0011] Preferably, the main control unit includes an internal control component and an external auxiliary device; the internal control component includes a CPU module, a data storage module and a communication module, and the communication module is communicatively connected to the CPU module; the external auxiliary device includes a data server; the CPU module is communicatively connected to the data server through the communication module, and a therapeutic efficacy evaluation operation program runs in the data server.

[0012] A method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus comprises the following steps: S1, builds a machine learning framework in the main control unit; S2, based on the machine learning framework, trains efficacy evaluation models for known types of electrotherapy diseases and known transdermal drugs, and generates a list of items that can be evaluated by the system; S3, starting the electrotherapy device, corresponding to inputting basic treatment information, including inputting basic patient information, selecting the working mode of the electrotherapy device, and inputting mode information; wherein the basic patient information includes the disease type, age, gender, and treatment site; the working modes of the electrotherapy device include electrotherapy output, electroporation output, and iontophoresis drug output; S4, the electrotherapy device starts to operate according to the selected working mode, and during the operation, it collects corresponding human electrical parameters and monitors and controls its own operating status in real time; S5, after the output and collection work of the electrotherapy device is completed, the main control unit determines whether the human body electrical parameter data collected in this work is complete; if not, the human body electrical parameter data collected in this work is invalid; if so, enter step S6; S6, the main control unit determines whether the project of this work service is in the list of evaluable projects of the system; if not, it proceeds to step S6-1, if so, it proceeds to step S6-2; S6-1, storing the basic treatment information and the human body electrical parameter data collected in this work as patient data; S6-2, based on the human electrical parameter data collected in this work, the corresponding efficacy evaluation model is used to analyze and obtain the efficacy evaluation results, and then the efficacy evaluation results, basic treatment information and human electrical parameter data are stored together as patient information; S7, query and display patient information through human-computer interaction components.

[0013] Preferably, in step S1, an RNN recurrent neural network model is used as a core algorithm to construct a machine learning framework.

[0014] Preferably, in step S3, when the working mode of the electrotherapy device is selected as electrotherapy output, the input mode information includes the treatment prescription and the output intensity; when the working mode of the electrotherapy device is selected as electroporation output or iontophoresis output, the input mode information includes the electroporation program and the name of the drug to be introduced.

[0015] Preferably, when the working mode of the electrotherapy device is selected as electrotherapy output in step S3, in step S4, the operation of the electrotherapy device includes the following steps: S41-1, the main control unit controls the signal switching unit to switch the system function to the B-type impedance measurement module, controls the B-type impedance measurement module to cooperate with the electrode assembly to complete a B-type impedance measurement, and temporarily stores the measured B-type impedance data; S41-2, the main control unit controls the signal switching unit to switch the system function to the surface electromyography measurement module, controls the surface electromyography measurement module to cooperate with the electrode assembly to complete a surface electromyography parameter measurement, and temporarily stores the measured surface electromyography parameters; S41-3, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output a set working electric signal to the electrode assembly; S41-4, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance in real time according to the working electric signal and transmits them to the main control unit; the main control unit controls the working state of the electric pulse signal generating module according to the current value and the A-type impedance; S41-5, the main control unit determines whether the system preset sampling time has been reached; if so, it proceeds to step S41-6; if not, it proceeds to step S41-7; S41-6, the main control unit determines whether the working service time in the treatment prescription has been reached; if so, it proceeds to step S41-7; if not, it directly returns to step S41-1; S41-7, calling step S41-1 and step S41-2 to complete the last measurement of B-type impedance and surface electromyography parameters; S41-8, the system signal output and collection work is completed, and the B-type impedance and surface electromyography parameters collected during this operation are used as human electrical parameter data for evaluating the therapeutic effect.

[0016] Preferably, when the working mode of the electrotherapy device is selected as electrotherapy hole output in step S3, in step S4, the operation of the electrotherapy device includes the following steps: S42-1, the main control unit controls the signal switching unit to switch the system function to the B-type impedance measurement module, controls the B-type impedance measurement module to cooperate with the electrode assembly to complete a B-type impedance measurement, and temporarily stores the measured B-type impedance data; S42-2, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output a round of working electric signals of the set electroporation pulse to the electrode assembly; S42-3, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance according to the working electric signal in real time and transmits them to the main control unit; the main control unit controls the working state of the electric pulse signal generating module according to the current value and the A-type impedance; S42-4, the main control unit determines whether a round of setting the working electrical signal output of the electroporation pulse is completed; if so, call step S42-1, complete a B-type impedance measurement, and temporarily store the measured B-type impedance data, and then enter step S42-5; if not, return to step S42-3; S42-5, the system signal output and collection work is completed, and the B-type impedance data collected during this operation is used as human electrical parameter data for evaluating the therapeutic effect.

[0017] Preferably, when the working mode of the electrotherapy device is selected as electrotherapy hole output in step S3, in step S4, the operation of the electrotherapy device includes the following steps: S43-1, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output a set working electric signal to the electrode assembly; S43-2, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance according to the working electric signal in real time and transmits them to the main control unit; the main control unit controls the working state of the electric pulse signal generating module according to the current value and the A-type impedance, and integrates the collected current value; S43-3, the main control unit determines whether the drug guiding work corresponding to the current work service is completed; if so, it proceeds to step S43-4; if not, it returns to step S43-2; S43-4, the system signal output and collection work is completed, and the final value of the current integration is obtained based on the working electrical signal collected by the type A impedance measurement module in step S43-2, and the final value of the current integration is used as the human body electrical parameter data for evaluating the therapeutic effect.

[0018] Preferably, in the step S4, the real-time monitoring and control of its own operating status is that the main control unit determines in real time whether there is any connection abnormality in the output path of the electric pulse signal generating module according to the current value and the A-type impedance data transmitted by the A-type impedance measurement module, including electrode detachment abnormality, short circuit abnormality and current abnormality; if there is a connection abnormality, the electric pulse signal generating module is immediately controlled to stop outputting the working electric signal, and the output and collection work of the electrotherapy device is terminated; if there is no connection abnormality, it continues to run.

[0019] Compared with the prior art, the advantages of this technical solution are: 1) It has significant advantages in efficacy evaluation. Through the multimodal human physiological electrical parameter acquisition unit, multiple electrical parameters are collected, and a correlation model between the disease course and electrical parameters is established to achieve accurate evaluation based on the model. The model data can expand the disease types over time, overcoming the limitations of existing electrotherapy devices that are single, inaccurate, and unable to distinguish between disease types, making the efficacy evaluation more scientific, accurate, and adaptable.

[0020] 2) Functional integration and process design are more reasonable. It integrates multiple functional controls and efficacy evaluations such as electrotherapy, electroporation, and iontophoresis. At the same time, each function has a clear and standardized operation process, from starting the system to the final data storage. Compared with some existing instruments with single functions or lack of effective evaluation processes, it is easy to use, complete in functions, and clear in structure.

[0021] 3) It has real-time monitoring and abnormality handling capabilities. When the working electrical signal is output, it can monitor the circuit status in real time, promptly detect electrode detachment, short circuit, current abnormality, etc., and quickly control the module to stop working and subsequent processing, effectively ensuring the safety and effectiveness of treatment.

[0022] 4) Data management and display are convenient and efficient. Treatment information, electrical parameter data and efficacy evaluation results can be integrated and stored as patient data, and can be easily queried and displayed through human-computer interaction components. This has changed the previous situation of relying on subjective feelings and simple records, lacking systematic data management and intuitive feedback, and provides strong support for the improvement of medical records and communication between doctors and patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is a basic principle block diagram of the efficacy evaluation and control system of an electrotherapy device; Figure 2 This is a block diagram of the optimal structural principle of the functional operation unit in this technical solution; Figure 3 It is a basic implementation flow chart of a method for evaluating and controlling the efficacy of an electrotherapy apparatus; Figure 4 It is a flow chart of the preferred implementation in the electrotherapy output working mode; Figure 5 It is a preferred implementation flow chart in the electroporation output working mode; Figure 6 This is a flow chart of the preferred implementation in the iontophoresis drug output working mode. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution of the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings of the embodiments of the present invention. It should not be understood that the present invention is limited to the following examples. Without departing from the concept of the present invention, the deformation and improvement of the present invention in this field should be included in the protection scope of the claims of the present invention.

[0025] Unless otherwise defined, the technical terms or scientific terms used in the present disclosure should be understood by people with ordinary skills in the field to which the present disclosure belongs. The words "or", "comprising" and the like used in the present disclosure mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects.

[0026] Example 1 This embodiment discloses an efficacy evaluation and control system of an electrotherapy apparatus, as a preferred embodiment of the present invention. Figure 1 As shown, it mainly includes a power supply unit and a functional operation unit, and the power supply unit is electrically connected to the functional operation unit. The power supply unit is responsible for supplying working power to the functional operation unit, and its power source is diverse, which can come from the mains, or it can be a primary battery or a rechargeable battery. The functional operation unit includes a main control unit, a human-computer interaction component, an electrode component, an electric pulse signal generation module, a physiological electrical parameter acquisition unit and a signal switching unit. Each component works together to realize the various functions of the electrotherapy instrument, including the control of electrotherapy operations, the acquisition of human electrical parameters, the evaluation of therapeutic effects, and human-computer interaction.

[0027] The main component of the signal switching unit is a relay, which is connected to the CPU module of the main control unit. It can change the connection relationship between the treatment electrode and each functional component under the control of the CPU module, so as to flexibly meet different treatment needs and measurement tasks and ensure the accurate conduction of electrical signals. When in use, the electrode assembly is directly attached to the corresponding part of the human body to conduct various electrical signals.

[0028] The structure of the electrode assembly can be selected from the following three schemes: 1) The same electrode internal switching channel scheme, that is, the measuring electrode and the treatment electrode are the same electrode, and the measurement and treatment channels are switched inside the instrument. 2) The electrode internal partition insulation scheme, that is, the electrode assembly appears as a whole, but its interior is divided into two mutually insulated parts, treatment and measurement. 3) Completely independent electrode scheme, that is, the treatment electrode and the measuring electrode are completely independent. Different electrode assembly implementation schemes have their own advantages. In the actual design and application of electrotherapy instruments, the appropriate scheme can be selected according to the specific treatment needs, usage scenarios, and emphasis on accuracy, convenience, etc., to better support the realization of various functions of the electrotherapy instrument and improve the electrotherapy effect and user experience.

[0029] The physiological electrical parameter acquisition unit is electrically connected to the main control unit, and is electrically connected to the electrode assembly through the signal switching unit. Its main function is to cooperate with the electrode assembly to collect human electrical parameters, and the collected human electrical parameters will be transmitted to the main control unit for temporary storage in a timely manner. These human electrical parameters can reflect the changes in the physiological state of the human body during electrotherapy, electroporation or iontophoresis, and provide a key data basis for subsequent efficacy evaluation.

[0030] As the control center of the entire system, the main control unit is electrically connected to the electric pulse signal generating module and runs the electrotherapy instrument control program. On the one hand, it outputs precise control signals to the electric pulse signal generating module according to the preset working service program, thereby regulating the generation and output of electric pulse signals to meet the control requirements of different service items under different working modes. On the other hand, it conducts in-depth analysis and processing based on the human body electrical parameters collected and transmitted by the physiological electrical parameter acquisition unit, and uses specific algorithms to obtain the efficacy evaluation results. In addition, it is also responsible for storing patient information, including basic information of patients, electrotherapy history records, and efficacy data, so that doctors or operators can check and track the patient's treatment progress at any time.

[0031] The electric pulse signal generating module is electrically connected to the physiological electrical parameter acquisition unit, and is electrically connected to the electrode assembly through the signal switching unit. The core function of the electric pulse signal generating module is to generate and output the set working electrical signal to the electrode assembly according to the control signal output by the main control unit. These working electrical signals act on the human body with specific pulse forms, frequencies, intensities and other parameters to meet the needs of human electrotherapy, electroporation or iontophoresis. At the same time, the physiological electrical parameter acquisition unit monitors the working state of the electric pulse signal generating module in real time according to the working electrical signal, and uploads the monitoring data to the main control unit. The main control unit controls the working state of the electric pulse signal generating module in real time according to the monitoring data. For example, when it is detected that the strength of the electrical signal output by the electric pulse signal generating module deviates from the preset range, the main control unit can timely adjust the working parameters of the electric pulse signal generating module, or stop the electric pulse signal generating module, to ensure the safety and effectiveness of the electrotherapy process.

[0032] The human-computer interaction component is electrically connected to the main control unit, and plays an important role in information display and input in the entire electrotherapy device system. This includes: users can select the working mode of the electrotherapy device and input the corresponding basic treatment information through the human-computer interaction component, and can also check patient information through the human-computer interaction component. Among them, patient information includes basic treatment information, efficacy evaluation data, and human electrical parameter data. The human-computer interaction component includes embedded components and / or independent display and control devices. Embedded components (such as touch screens) are directly embedded in the casing of the electrotherapy device, which is convenient for on-site operators to directly operate and view; independent display and control devices (such as mobile phones, computers, etc.) are connected to the electrotherapy device by wireless or wired communication, and can independently run data calculation logic programs, which provides support for remote control and data analysis.

[0033] Example 2 This embodiment discloses an efficacy evaluation and control system of an electrotherapy device, as a preferred implementation scheme of the present invention, that is, based on Example 1, its physiological electrical parameter acquisition unit includes a type A impedance measurement module, a type B impedance measurement module and a surface electromyography measurement module. These three main modules each undertake a specific human electrical parameter acquisition task, obtain relevant data of the human body during the electrotherapy process from different dimensions, and provide rich and accurate information support for the main control unit to perform comprehensive efficacy evaluation and system control. In addition, in this technical solution, the type A impedance measurement module and the type B impedance measurement module together constitute a dual-mode bioimpedance measurement unit, which has two different modes of bioimpedance measurement capabilities, can measure the impedance of the treatment part of the human body, and provide key data support for the safe operation of the electrotherapy device, function realization, and treatment efficacy evaluation.

[0034] For mode one: using electric pulse signals as excitation signals to measure impedance, its uniqueness lies in that the impedance measurement and the output of electric pulse signals are carried out simultaneously. During the operation of the electrotherapy device, along with the electric pulse signal acting on the human body, the impedance measurement module in this mode simultaneously carries out the detection of human body impedance. Based on this, the type A impedance measurement module is electrically connected to the main control unit and the electric pulse signal generating module respectively. The type A impedance measurement module and the electric pulse signal generating module are closely connected and work synchronously. Its core function is to obtain the current value and impedance value (type A impedance) based on the working electrical signal output by the electric pulse signal generating module, and transmit these data to the main control unit. Based on the obtained current value and type A impedance, the main control unit monitors and effectively controls the working status of the electric pulse signal generating module in real time.

[0035] Functional implementation (A function - determine the electrode connection status): This mode has an important A function, which is used to determine whether the electrode assembly is in good contact with the human body. At the beginning of the work, if the measured impedance is greater than the preset threshold value of unconnected, it can be accurately judged that the electrode assembly is not connected well; and when the measured impedance is lower than the preset threshold value of short circuit, it means that the electrode assembly is short-circuited. At this time, the electric pulse signal generating module will stop working to avoid safety problems caused by abnormal connection. During the treatment, if the measured impedance increases or decreases by more than the preset threshold, it means that the electrode may fall off or short-circuit. At this time, the protection mechanism will be triggered to timely reduce or shut down the output of the electric pulse signal generating module, thereby ensuring the safety of the electrotherapy process and the normal operation of the electrotherapy device.

[0036] Function realization (B function - automatic adjustment function): Mode 1 also has B function, which is the optional automatic adjustment function. Since the impedance of different patients or different treatment parts of the same patient is quite different, the difference in the current flowing through will be obvious even at the same output voltage. By measuring the A-type impedance and then adjusting the voltage within a certain range, the adjustment rule is that when the impedance is large, the output voltage level is increased accordingly to ensure that the current flowing through does not differ too much, thereby achieving the effect of stabilizing the output intensity, so that the electrotherapy process can better adapt to the actual conditions of different individuals and different parts. This function is also used to stabilize the current during iontophoresis, because iontophoresis generally works in constant current mode.

[0037] For mode 2: an independent impedance measurement excitation signal is used to measure bioimpedance. Unlike mode 1, the measurement of impedance in this mode must interrupt the electric pulse signal. This is because the impedance of human tissue has nonlinear characteristics, and the impedance measured under different excitations is different. The treatment excitation signal of mode 1 is not fixed in terms of waveform, intensity, time, etc., and the measured impedance lacks comparability. The measurement excitation signal used in mode 2 is a fixed set of excitation signals specifically used for impedance measurement, and does not participate in the output control of the electric pulse signal. Therefore, the impedance measurement and treatment functions of mode 2 are mutually exclusive. In order to avoid interference, the output of the electric pulse signal must be suspended during measurement. Based on this, the B-type impedance measurement module is electrically connected to the main control unit and is electrically connected to the electrode assembly through the signal switching unit. The B-type impedance measurement module contains a multi-frequency sine wave signal generator and a signal demodulator, and its working parameters such as the excitation signal cannot be adjusted by the user. The main function of the B-type impedance measurement module is to cooperate with the electrode assembly to obtain the human body impedance parameters (B-type impedance) covering multi-dimensional information such as impedance value, phase angle, resistance value and reactance value by measuring the response of human tissue under the excitation of sinusoidal signals at different frequencies, and transmit these parameters to the main control unit. These rich human body impedance parameters can more comprehensively reflect the changes in the electrical properties of human tissue during electrotherapy or electroporation. For example, changes in phase angle can provide information about the state of human tissue cells and the propagation characteristics of electrotherapy energy in tissues; resistance value and reactance value can respectively reflect the resistance of human tissue to current and the capacitive and inductive responses.

[0038] Function and effect: Mode 2 This independent impedance measurement function can obtain relatively accurate impedance values, and its measurement results are of great significance for evaluating treatment effects and optimizing treatment plans. Doctors can use these accurate impedance data to gain a deeper understanding of the effects of electrotherapy on human tissues, and then make targeted adjustments to existing treatment plans, such as adjusting the parameters of the electrical pulse signal, the output duration of the electrical pulse signal, etc., to improve the accuracy and efficacy of treatment.

[0039] Furthermore, the surface electromyography measurement module is electrically connected to the main control unit, and is electrically connected to the electrode assembly through the signal switching unit. The function of the surface electromyography measurement module is to cooperate with the electrode assembly to collect the surface electromyography parameters of the human body, and transmit these parameters to the main control unit in a timely manner. The surface electromyography signal of the human body is an electrophysiological phenomenon accompanying muscle activity, and its parameters can reflect important information such as the contraction state of the muscle, the degree of fatigue, and the functional state of the neuromuscular system. During the electrotherapy process, by collecting and analyzing the surface electromyography parameters, the main control unit can determine the changes in muscle function caused by electrotherapy. The measurement and treatment functions are mutually exclusive. In order to avoid interference, the output of the electrical pulse signal of the surface electromyography measurement module should be suspended during measurement.

[0040] In this technical solution, the two modes of the dual-mode bioimpedance measurement unit have their own characteristics and complement each other. Mode 1 monitors in real time during the output of the electric pulse signal to ensure the safe output of the electric pulse signal and realize the automatic adjustment function; Mode 2 focuses on obtaining accurate impedance values ​​to provide a reliable basis for subsequent efficacy evaluation and program optimization. The two work together to play an important role in the overall operation of the electrotherapy device, the improvement of treatment effects, and the safety of patients from different angles, making the electrotherapy process more scientific, accurate and safe, and helping to promote electrotherapy technology in the medical field to better serve patients. On this basis, the surface electromyography measurement module collects and analyzes the surface electromyography parameters of the human body, and uses the data obtained by the dual-mode bioimpedance measurement unit as the input data for efficacy analysis. Especially in the evaluation of the treatment effect of muscle-related diseases, the combination of this multi-dimensional data is of great significance.

[0041] Example 3 This embodiment discloses an efficacy evaluation and control system of an electrotherapy device, as a preferred implementation scheme of the present invention, that is, based on Example 1 or 2, its main control unit includes an internal control component and an external auxiliary device; the internal control component includes a CPU module, a data temporary storage module and a communication module, and the communication module is communicatively connected to the CPU module; the external auxiliary device includes a data server; the CPU module is communicatively connected to the data server through the communication module, and an efficacy evaluation operation program runs in the data server.

[0042] As the computing core of the main control unit, the CPU module undertakes many key tasks. First, it establishes connections with the human-computer interaction component, electric pulse signal generating module, signal switching unit and physiological electrical parameter acquisition unit of the electrotherapy instrument to realize the reception of data and the sending of instructions. For example, it receives the human body electrical parameters from the physiological electrical parameter acquisition unit and performs preliminary processing and analysis on these data. At the same time, according to the preset program logic, a control signal is sent to the electric pulse signal generating module to adjust the output parameters of the electric pulse to meet the needs of different electrotherapy scenarios. In addition, the data storage module connected to the CPU module can store a large amount of temporary data, including real-time data during electrotherapy, basic information of patients and past records, etc. These data provide a data basis for subsequent efficacy evaluation and system operation.

[0043] The data server is a key facility for large-scale data storage and complex efficacy evaluation calculations. It receives various data uploaded from the CPU module, including the patient's electrotherapy history data, real-time human electrical parameter data during this electrotherapy process, etc. Based on these rich data resources, the data server uses the efficacy evaluation calculation program it runs, and adopts advanced algorithms and data analysis models to conduct a comprehensive, in-depth and objective evaluation of the efficacy of electrotherapy.

[0044] The efficacy evaluation operation program has the function of evaluating the efficacy of electrotherapy equipment based on machine learning. With the help of machine learning algorithms and big data processing, it collects multi-dimensional human physiological data such as type A and type B impedance and surface electromyography, and combines patient information and efficacy standards to train the optimization model. It automatically analyzes the changing trends of physiological parameters before and after electrotherapy, electroporation or iontophoresis, gives quantitative scores and detailed reports, deeply interprets the relationship between parameter changes and symptoms, and can continuously learn and adapt to new data patterns, providing strong support and decision-making basis for personalized electrotherapy plans, clinical research and improvement of medical quality.

[0045] In this technical solution, modules with different functions are reasonably divided and connected, realizing modularization and specialization of functions. Each module performs its own duties and cooperates with each other, which improves the working efficiency and stability of the entire main control unit. For example, the CPU module focuses on calculation and control, the data server focuses on data storage and complex calculations, and the communication module guarantees data transmission, making the operation of the system more orderly and efficient. Secondly, by running the efficacy evaluation calculation program on the data server, a multi-level and multi-angle analysis of the efficacy evaluation is realized, which can make full use of internal and external resources to provide more scientific, accurate and comprehensive evaluation results for electrotherapy, electroporation, and iontophoresis. Furthermore, the setting of the data temporary storage module optimizes the data processing flow of the CPU module, improves the overall performance of the system, ensures that the electrotherapy instrument can operate stably in various complex electrotherapy scenarios, and provides reliable electrotherapy services for patients. Finally, this architecture design also provides convenience for the functional expansion and upgrading of the electrotherapy instrument, such as upgrading the efficacy evaluation calculation program in the data server or adding new functional modules to the external terminal to continuously improve the overall performance and service level of the electrotherapy instrument to adapt to the ever-evolving medical needs and technological progress.

[0046] Example 4 This embodiment discloses a method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus. As a preferred implementation scheme of the present invention, an electrotherapy apparatus therapeutic effect evaluation and control system based on the technical scheme is carried out, comprising the following steps: S1, build a machine learning framework in the data server of the main control unit. The machine learning framework is an infrastructure based on artificial intelligence technology that can use a large amount of data for learning and pattern recognition. Through this framework, technical support is provided for the subsequent training of efficacy evaluation models for different types of electrotherapy diseases and transdermal drugs. More specifically, the RNN recurrent neural network model can be used as the core algorithm to build a machine learning framework.

[0047] S2, based on the machine learning framework, train the efficacy evaluation model for known types of electrotherapy diseases and known transdermal drugs, and generate a list of system-evaluable items. For types of electrotherapy diseases, a large number of data on changes in human electrical parameters and feedback data on treatment effects of patients with specific diseases during electrotherapy are collected as training samples, and the relationship between these data is learned based on the model, so as to predict and evaluate the efficacy of new patients during electrotherapy for the same disease. For transdermal drugs, data on the penetration effects of different drugs in the human body and data on synergy with electrotherapy are also collected under the iontophoresis drug output mode for model training. After completing the model training, a list of system-evaluable items is generated. This list covers all types of electrotherapy diseases and transdermal drug projects corresponding to the trained models, and is the basis for subsequent judgment on whether the electrotherapy project can be evaluated for efficacy.

[0048] S3, after starting the electrotherapy device, the user needs to input basic treatment information, including inputting basic patient information, selecting the working mode of the electrotherapy device, and inputting mode information. Among them, the basic information of the patient includes the type of disease, age, gender and treatment site. The working mode of the electrotherapy device includes electrotherapy output, electroporation output and iontophoresis output. Different working modes are suitable for different treatment needs. For example, electrotherapy output mainly focuses on stimulating human tissues through electric pulses to achieve the purpose of relieving pain and promoting blood circulation; electroporation output can form tiny channels on the surface of the skin, which is conducive to the penetration of subsequent drugs; iontophoresis output uses the electric field to introduce drug ions into human tissues. While selecting the working mode, the basic treatment information is input accordingly. The basic treatment information may include the patient's age, gender, diseased site, duration of illness, etc. This information is helpful for comprehensive recording and analysis of the patient's condition in subsequent efficacy evaluation and data storage.

[0049] S4, the electrotherapy device starts to operate according to the selected working mode, and during the operation, the corresponding human body electrical parameters are collected through the physiological electrical parameter acquisition unit, such as obtaining current value and impedance value through the A-type impedance measurement module, collecting multi-dimensional impedance parameters through the B-type impedance measurement module, and collecting human body surface electromyography parameters through the surface electromyography measurement module. At the same time, the electrotherapy device monitors and controls its own operating status in real time, such as whether the output parameters of the electric pulse signal generation module are stable, whether the contact between the electrode assembly and the human skin is good, etc. These collected data and monitoring information will provide a basis for the evaluation of efficacy and the judgment of the system operation status.

[0050] S5, after the output and collection of the electrotherapy device is completed, the main control unit determines whether the human electrical parameter data collected in this work is complete. Data integrity is an important prerequisite for ensuring the accuracy of the efficacy evaluation. If the data is missing or incomplete, it may cause deviations in the efficacy evaluation results. Therefore, if the data is incomplete, the human electrical parameter data collected in this work will be invalidated and the electrotherapy collection needs to be performed again; if it is complete, proceed to the next step.

[0051] S6, the main control unit determines whether the project served by this work is in the list of system evaluable projects. This step is the key link to determine whether the efficacy evaluation can be performed. If the project is not in the list of system evaluable projects, it means that an effective efficacy evaluation model may not have been trained for the project. If not, go to step S6-1, if yes, go to step S6-2.

[0052] S6-1, the basic treatment information and the human electrical parameter data collected in this work are stored as patient information. These stored data can be accumulated. As the amount of data increases, these data can be used to optimize the machine learning framework or train new efficacy evaluation models, gradually improve the efficacy evaluation system of the electrotherapy device, and improve its ability to evaluate more types of diseases and treatment projects. S6-2, based on the human electrical parameter data collected in this work, the corresponding efficacy evaluation model is used to analyze and obtain the efficacy evaluation results, and then the efficacy evaluation results, basic treatment information and human electrical parameter data are stored together as patient information.

[0053] S6-2, based on the human electrical parameter data collected in this work, the corresponding efficacy evaluation model is used to analyze and obtain the efficacy evaluation results. Based on the input human electrical parameter data, combined with its learned patterns and rules, the model outputs an evaluation of the effect of this electrotherapy, such as the degree of improvement of the patient's symptoms by electrotherapy, whether the drug penetration effect meets expectations, etc. The efficacy evaluation results, basic treatment information and human electrical parameter data are then stored together as patient information. Such complete patient information storage is conducive to doctors' comprehensive review of the patient's treatment process, and also helps to continuously verify and optimize the efficacy evaluation model of the electrotherapy device.

[0054] S7, through the human-computer interaction component to query and display patient information. It is convenient for doctors, patients or researchers to view relevant information of electrotherapy at any time. Doctors can adjust treatment plans according to the efficacy evaluation results in patient data, patients can understand their treatment progress and effects, and researchers can use these data for data analysis and research, further explore the mechanism of action of electrotherapy, explore new treatment methods and optimize existing efficacy evaluation models.

[0055] Example 5 This embodiment discloses a method for evaluating and controlling the therapeutic effect of an electrotherapy device. As a preferred implementation of the present invention, based on Example 4, in step S3, the working mode of the electrotherapy device is selected as electrotherapy output, and the input mode information includes a treatment prescription and output intensity. Based on this, in step S4, the operation of the electrotherapy device includes the following steps: S41-1, the main control unit controls the signal switching unit to switch the system function to the B-type impedance measurement module, and controls the B-type impedance measurement module to cooperate with the electrode assembly to complete a B-type impedance measurement. B-type impedance covers multi-dimensional information such as impedance value, phase angle, resistance value and reactance value. The data measured at different times can reflect the electrical characteristics of human tissue at different stages of electrotherapy, and then they are temporarily stored to provide basic data support for subsequent efficacy evaluation and system operation status judgment.

[0056] S41-2, the main control unit controls the signal switching unit to switch the system function to the surface electromyography measurement module, controls the surface electromyography measurement module to cooperate with the electrode assembly to complete a surface electromyography parameter measurement, and temporarily stores the measured surface electromyography parameters. The surface electromyography parameters of the human body can reflect the activity state, contraction degree and neuromuscular function of the muscle. The change of its parameters during the electrotherapy process is of great significance for evaluating the effect of electrotherapy on muscle-related functions. The measured data will also be temporarily stored for subsequent comprehensive analysis of the electrotherapy effect.

[0057] S41-3, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output the set working electric signal to the electrode assembly.

[0058] S41-4, during the period when the electric pulse signal generating module outputs the working electric signal, the type A impedance measurement module obtains the current value and the type A impedance in real time according to the working electric signal and transmits them to the main control unit; the main control unit determines in real time whether there is any connection abnormality in the output path of the electric pulse signal generating module, including electrode detachment abnormality, short circuit abnormality and current abnormality, according to the current value and type A impedance data transmitted by the type A impedance measurement module; if there is a connection abnormality, the electric pulse signal generating module is immediately controlled to stop outputting the working electric signal, and the process goes to step S41-9; if there is no connection abnormality, the process goes to step S41-5.

[0059] S41-5, the main control unit determines whether the preset sampling time of the system has been reached. This preset sampling time is set in advance and is used to regularly collect relevant data so as to more comprehensively and accurately record the electrophysiological changes of the human body during the electrotherapy process. If the preset sampling time has been reached, the process proceeds to step S41-6; if not, the process proceeds to step S41-7.

[0060] S41-6, the main control unit determines whether the working service time in the treatment prescription has been reached. The working service time in the treatment prescription stipulates the duration of a specific service stage during the electrotherapy process. If the time requirement has been reached, it means that the electrotherapy service of this stage has completed the corresponding duration, and then enters step S41-7; if not, it directly returns to step S41-1 and restarts a round of measurement and electric pulse signal output operations of each module, and continues the electrotherapy process and collects data.

[0061] S41-7, call step S41-1 and step S41-2 to complete the last B-type impedance measurement and surface electromyography parameter measurement. The purpose of this is to obtain the electrophysiological parameters of the human body at the end of the electrotherapy, and combine them with the previously stored data of each stage to more completely present the changes in the electrical characteristics of the human body and muscle-related states during the entire electrotherapy process, providing a comprehensive data basis for the subsequent accurate evaluation of the electrotherapy effect.

[0062] S41-8, the system signal output and collection work is completed, and the B-type impedance and surface electromyography parameters collected during this operation are used as human electrical parameter data for evaluating the therapeutic effect. These data carry key information about the changes in the physiological state of the human body during electrotherapy. The actual effect of electrotherapy will be comprehensively analyzed based on these data and corresponding evaluation models, thereby providing strong data support for doctors to adjust treatment plans and evaluate treatment effectiveness.

[0063] Example 6 This embodiment discloses a method for evaluating and controlling the efficacy of an electrotherapy device. As a preferred implementation of the present invention, based on Example 4, in step S3, the working mode of the electrotherapy device is electroporation output, and the input mode information includes the electroporation program and the name of the drug to be introduced. Based on this, in step S4, the operation of the electrotherapy device includes the following steps: S42-1, the main control unit controls the signal switching unit to switch the system function to the B-type impedance measurement module, and controls the B-type impedance measurement module to cooperate with the electrode assembly to complete a B-type impedance measurement. Type B impedance covers multi-dimensional information such as impedance value, phase angle, resistance value and reactance value. The data obtained from the first measurement can reflect the electrical characteristics of the corresponding part of the human body before the electroporation operation, and has important reference value for the subsequent evaluation of the impact of the electroporation process on the electrical properties of human tissue. After the measurement is completed, it will be temporarily stored for subsequent analysis.

[0064] S42-2, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output a round of working electric signals of the electroporation pulse to the electrode assembly. The electroporation pulse working electric signal here has specific parameter settings, which are determined according to the selected electroporation program. Its purpose is to use electric pulses to create tiny channels on human skin for the subsequent introduction of drugs and to start the key operation process of electroporation.

[0065] S42-3, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance according to the working electric signal in real time and transmits it to the main control unit; the main control unit determines in real time whether there is a connection abnormality in the output path of the electric pulse signal generating module, including electrode detachment abnormality, short circuit abnormality and current abnormality, according to the current value and A-type impedance data transmitted by the A-type impedance measuring module. If there is a connection abnormality, the electric pulse signal generating module is immediately controlled to stop outputting the working electric signal, and the process goes to step S42-5; if there is no connection abnormality, the process goes to step S42-4.

[0066] S42-4, the main control unit determines whether a round of set electroporation pulse working electrical signal output is completed. Whether this round of output is completed or not is determined according to the pre-set electroporation program requirements. If a round of output has been completed, then call step S42-1, complete the B-type impedance measurement again, and temporarily store the newly measured B-type impedance data. By comparing the changes in the B-type impedance data before and after, it is possible to intuitively understand the impact of the electroporation operation on the electrical properties of human tissue. Then enter step S42-5; if a round of output has not been completed, return to step S42-3, continue to maintain real-time monitoring of the working status of the electric pulse signal generating module and the output of the electroporation pulse working electrical signal, until a round of set output is completed.

[0067] S42-5, the system signal output and collection work is completed, and the B-type impedance data collected during this operation is used as the human electrical parameter data for evaluating the therapeutic effect. Since the electroporation output mode focuses on the impact of the electroporation operation on human tissue, and the B-type impedance data can well reflect the changes in the electrical properties of human tissue, it is selected as the key data for evaluating the therapeutic effect. In the future, based on these data and combined with the corresponding evaluation model, the actual effect of the electroporation operation can be analyzed, such as judging whether the manufactured pores meet expectations and the potential impact on the subsequent drug introduction, etc., so as to provide data support for further optimizing the treatment plan and improving the treatment effect.

[0068] Example 7 This embodiment discloses a method for evaluating and controlling the efficacy of an electrotherapy device. As a preferred embodiment of the present invention, based on Example 4, the working mode of the electrotherapy device in step S3 is iontophoresis drug output, and the input mode information includes the electroporation program and the name of the drug to be introduced. Based on this, in step S4, the operation of the electrotherapy device includes the following steps: S43-1, the main control unit switches the system function to the electric pulse signal generation module through the control signal switching unit, and then controls the module to output the set working electrical signal to the electrode assembly. In the iontophoresis drug delivery output mode, this working electrical signal has specific parameter settings, and its purpose is to use the electric field force to push the drug ions through the skin and other human tissues into the body, start the key process of iontophoresis drug delivery, and lay the foundation for subsequent drug introduction.

[0069] S43-2, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance according to the working electric signal in real time and transmits it to the main control unit; the main control unit integrates the collected current value according to the current value and the A-type impedance data transmitted by the A-type impedance measuring module, and determines in real time whether there is a connection abnormality in the output path of the electric pulse signal generating module, including electrode detachment abnormality, short circuit abnormality and current abnormality. If there is a connection abnormality, the electric pulse signal generating module is immediately controlled to stop outputting the working electric signal, and the process goes to step S43-4; if there is no connection abnormality, the process goes to step S43-3.

[0070] S43-3, the control unit determines whether the drug guiding work corresponding to this work service is completed. Whether the drug guiding work is completed here is determined based on the relevant pre-set standards, such as whether the set drug guiding time is full. If the drug guiding work has been completed, then enter step S43-4; if the drug guiding work has not been completed, return to step S43-2, continue to monitor the connection status and output the working electrical signal to ensure that the drug guiding process can be carried out continuously and stably until the drug guiding work is completed.

[0071] S43-4, when the system signal output and collection work is completed, based on the working electrical signal collected by the type A impedance measurement module in step S43-2, the final value of the current integral is obtained by a specific calculation method, and the final value of the current integral is used as the human body electrical parameter data for evaluating the therapeutic effect. In the process of iontophoresis, the final value of the current integral can reflect the situation of drug introduction to a certain extent, because there is often a correlation between the amount of introduced charge and the amount of drug ion migration. By analyzing this final value of the current integral, the effect of drug introduction into human tissue can be indirectly understood, and then the key data support for the subsequent evaluation of the efficacy of the iontophoresis output mode is provided, helping doctors to judge whether the treatment plan is effective and whether further adjustments are needed.

Claims

1. An efficacy evaluation and control system for an electrotherapy apparatus, comprising a power supply unit and a functional operation unit, wherein the power supply unit is electrically connected to the functional operation unit; characterized in that: The functional operation unit includes a main control unit, a human-computer interaction component, an electrode component, an electric pulse signal generating module, a physiological electrical parameter acquisition unit and a signal switching unit; The physiological electrical parameter acquisition unit is electrically connected to the main control unit, and is electrically connected to the electrode assembly through the signal switching unit, and is used to cooperate with the electrode assembly to collect human electrical parameters, and transmit the collected human electrical parameters to the main control unit; The main control unit is electrically connected to the electric pulse signal generating module, and runs an electrotherapy instrument control program inside the main control unit, including obtaining therapeutic effect evaluation results based on the collected human body electrical parameters, and outputting control signals to the electric pulse signal generating module according to a preset working service program; The electric pulse signal generating module is electrically connected to the physiological electrical parameter acquisition unit, and is electrically connected to the electrode assembly through the signal switching unit; it is used to output the set working electrical signal to the electrode assembly according to the control signal output by the main control unit; the physiological electrical parameter acquisition unit collects the working electrical signal in real time, and transmits the relevant data of the working electrical signal to the main control unit for monitoring and controlling the working state of the electric pulse signal generating module; The human-machine interaction component is electrically connected to the main control unit and is used to input electrotherapy information and display patient data including human electrical parameters and efficacy evaluation results.

2. An electrotherapy apparatus control system as claimed in claim 1, characterized in that: The physiological electrical parameter acquisition unit includes an A-type impedance measurement module, a B-type impedance measurement module and a surface electromyography measurement module; The A-type impedance measurement module is electrically connected to the main control unit and the electric pulse signal generating module respectively, and is used to obtain the current value and the impedance value according to the working electrical signal and transmit them to the main control unit; the main control unit names the impedance value as the A-type impedance, and monitors and controls the working state of the electric pulse signal generating module based on the current value and the A-type impedance; The B-type impedance measurement module is electrically connected to the main control unit and is electrically connected to the electrode assembly through the signal switching unit, and is used to cooperate with the electrode assembly to collect human body impedance parameters and transmit them to the main control unit; the main control unit names the impedance parameters as B-type impedance, including impedance value, phase angle, resistance value and reactance value; The surface electromyography measurement module is electrically connected to the main control unit and is electrically connected to the electrode assembly through the signal switching unit, and is used to cooperate with the electrode assembly to collect human surface electromyography parameters and transmit the surface electromyography parameters to the main control unit.

3. An electrotherapy apparatus control system as claimed in claim 1, characterized in that: The main control unit includes an internal control component and an external auxiliary device; the internal control component includes a CPU module, a data temporary storage module and a communication module, and the communication module is communicatively connected to the CPU module; the external auxiliary device includes a data server; the CPU module is communicatively connected to the data server through the communication module, and a therapeutic effect evaluation operation program runs in the data server.

4. A method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus, characterized in that: The following steps are involved: S1, builds a machine learning framework in the main control unit; S2, based on the machine learning framework, trains efficacy evaluation models for known types of electrotherapy diseases and known transdermal drugs, and generates a list of items that can be evaluated by the system; S3, starting the electrotherapy device, corresponding to inputting basic treatment information, including inputting basic patient information, selecting the working mode of the electrotherapy device, and inputting mode information; wherein the basic patient information includes the disease type, age, gender, and treatment site; the working modes of the electrotherapy device include electrotherapy output, electroporation output, and iontophoresis drug output; S4, the electrotherapy device starts to operate according to the selected working mode, and during the operation, it collects corresponding human electrical parameters and monitors and controls its own operating status in real time; S5, after the output and collection work of the electrotherapy device is completed, the main control unit determines whether the human body electrical parameter data collected in this work is complete; if not, the human body electrical parameter data collected in this work is invalid; if so, enter step S6; S6, the main control unit determines whether the project of this work service is in the list of evaluable projects of the system; if not, it proceeds to step S6-1, if so, it proceeds to step S6-2; S6-1, storing the basic treatment information and the human body electrical parameter data collected in this work as patient data; S6-2, based on the human electrical parameter data collected in this work, the corresponding efficacy evaluation model is used to analyze and obtain the efficacy evaluation results, and then the efficacy evaluation results, basic treatment information and human electrical parameter data are stored together as patient information; S7, query and display patient information through human-computer interaction components.

5. The method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus as claimed in claim 4, characterized in that: In step S1, the RNN recurrent neural network model is used as the core algorithm to build a machine learning framework.

6. The method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus as claimed in claim 4, characterized in that: In step S3, when the working mode of the electrotherapy device is selected as electrotherapy output, the input mode information includes the treatment prescription and the output intensity; when the working mode of the electrotherapy device is selected as electroporation output or iontophoresis output, the input mode information includes the electroporation program and the name of the drug to be introduced.

7. The method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus as claimed in claim 4, characterized in that: When the working mode of the electrotherapy device is selected as electrotherapy output in step S3, the operation of the electrotherapy device in step S4 includes the following steps: S41-1, the main control unit controls the signal switching unit to switch the system function to the B-type impedance measurement module, controls the B-type impedance measurement module to cooperate with the electrode assembly to complete a B-type impedance measurement, and temporarily stores the measured B-type impedance data; S41-2, the main control unit controls the signal switching unit to switch the system function to the surface electromyography measurement module, controls the surface electromyography measurement module to cooperate with the electrode assembly to complete a surface electromyography parameter measurement, and temporarily stores the measured surface electromyography parameters; S41-3, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output a set working electric signal to the electrode assembly; S41-4, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance in real time according to the working electric signal and transmits them to the main control unit; the main control unit controls the working state of the electric pulse signal generating module according to the current value and the A-type impedance; S41-5, the main control unit determines whether the system preset sampling time has been reached; if so, it proceeds to step S41-6; if not, it proceeds to step S41-7; S41-6, the main control unit determines whether the working service time in the treatment prescription has been reached; if so, it proceeds to step S41-7; if not, it directly returns to step S41-1; S41-7, calling step S41-1 and step S41-2 to complete the last measurement of B-type impedance and surface electromyography parameters; S41-8, the system signal output and collection work is completed, and the B-type impedance and surface electromyography parameters collected during this operation are used as human electrical parameter data for evaluating the therapeutic effect.

8. The method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus as claimed in claim 4, characterized in that: When the working mode of the electrotherapy device is selected as electrotherapy hole output in step S3, in step S4, the operation of the electrotherapy device includes the following steps: S42-1, the main control unit controls the signal switching unit to switch the system function to the B-type impedance measurement module, controls the B-type impedance measurement module to cooperate with the electrode assembly to complete a B-type impedance measurement, and temporarily stores the measured B-type impedance data; S42-2, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output a round of working electric signals of the set electroporation pulse to the electrode assembly; S42-3, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance according to the working electric signal in real time and transmits them to the main control unit; the main control unit controls the working state of the electric pulse signal generating module according to the current value and the A-type impedance; S42-4, the main control unit determines whether a round of setting the working electrical signal output of the electroporation pulse is completed; if so, call step S42-1, complete a B-type impedance measurement, and temporarily store the measured B-type impedance data, and then enter step S42-5; if not, return to step S42-3; S42-5, the system signal output and collection work is completed, and the B-type impedance data collected during this operation is used as human electrical parameter data for evaluating the therapeutic effect.

9. A method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus as claimed in claim 4, characterized in that: When the working mode of the electrotherapy device is selected as iontophoresis drug delivery in step S3, in step S4, the operation of the electrotherapy device includes the following steps: S43-1, the main control unit controls the signal switching unit to switch the system function to the electric pulse signal generating module, and then controls the electric pulse signal generating module to output a set working electric signal to the electrode assembly; S43-2, during the period when the electric pulse signal generating module outputs the working electric signal, the A-type impedance measuring module obtains the current value and the A-type impedance according to the working electric signal in real time and transmits them to the main control unit; the main control unit controls the working state of the electric pulse signal generating module according to the current value and the A-type impedance, and integrates the collected current value; S43-3, the main control unit determines whether the drug guiding work corresponding to the current work service is completed; if so, it proceeds to step S43-4; if not, it returns to step S43-2; S43-4, the system signal output and collection work is completed, and the final value of the current integration is obtained based on the working electrical signal collected by the type A impedance measurement module in step S43-2, and the final value of the current integration is used as the human body electrical parameter data for evaluating the therapeutic effect.

10. A method for evaluating and controlling the therapeutic effect of an electrotherapy apparatus as claimed in claim 4, characterized in that: In the step S4, the main control unit monitors and controls its own operating state in real time, and determines in real time whether there is a connection abnormality in the output path of the electric pulse signal generating module, including an electrode detachment abnormality, a short circuit abnormality, and a current abnormality, according to the current value and the A-type impedance data transmitted by the A-type impedance measurement module; if there is a connection abnormality, the electric pulse signal generating module is immediately controlled to stop outputting the working electric signal, and the output and collection work of the electrotherapy instrument for that time is terminated; If there is no connection anomaly, continue running.

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