Comprehensive therapeutic apparatus for treating coronary heart disease

Abstract

The invention discloses a comprehensive therapeutic apparatus for coronary heart disease treatment, which comprises a multi-mode sensor module, a control and data processing module, an electrical stimulation execution module and a communication and remote monitoring module, and is characterized in that the multi-mode sensor module is used for collecting physiological data of a patient in real time; the control and data processing module is connected with the multi-mode sensor module and is used for generating dynamic personalized treatment parameters according to historical treatment data and patient physiological data collected in real time based on an artificial intelligence self-learning algorithm; the electrical stimulation execution module is connected with the control and data processing module and is used for performing electrical stimulation treatment on the heart area of the patient according to the treatment parameters; and the communication and remote monitoring module is connected with the control and data processing module and is used for being connected with a monitoring terminal to realize bidirectional data communication. By integrating the multi-mode sensor module and the control and data processing module based on the artificial intelligence self-learning algorithm, personalized dynamic treatment of the patient is realized.

Description

Technical Field

[0001] The present invention relates to medical devices, and in particular to a comprehensive therapeutic apparatus for the treatment of coronary heart disease. Background Art

[0002] As a globally prevalent cardiovascular disease, traditional treatment methods for coronary heart disease include drug intervention, coronary artery intervention (stent implantation), and surgical bypass surgery. However, some patients cannot fully benefit due to complex vascular lesions, multiple comorbidities, or surgical contraindications. In recent years, neuromodulation techniques represented by spinal cord stimulation (SCS) have gradually been applied to the treatment of refractory angina. By regulating the activity of the autonomic nervous system with electrical pulses, improving myocardial blood flow distribution, and inhibiting pain signal conduction, it has become an important supplementary therapy. However, there are significant limitations in the technical implementation of existing coronary heart disease pulse treatment devices, restricting the further improvement of their clinical efficacy.

[0003] Currently, the working mode of such therapeutic apparatuses relies on manual presetting of pulse parameters (such as frequency, pulse width, amplitude, and stimulation waveform), and doctors need to make empirical adjustments based on the static assessment results of patients (such as electrocardiogram, exercise stress test) and subjective symptom feedback. However, the physiological state of coronary heart disease patients is highly dynamic and may change in real time with circadian rhythm, exercise load, emotional fluctuations, or environmental factors. The fixed-parameter stimulation scheme cannot dynamically match the immediate needs of patients, resulting in the following problems: First, when the stimulation intensity is insufficient, it is difficult to effectively inhibit ischemic pain or improve blood flow, and excessive stimulation may cause side effects such as arrhythmia or hypotension. Second, the daily activities of patients (such as exercise, body position changes) may require different neuromodulation strategies due to fluctuations in cardiovascular demands. Traditional devices lack an adaptive feedback mechanism, and the treatment lag is significant. Third, long-term reliance on manual adjustment requires frequent follow-up visits, increasing the medical burden and making it difficult to capture sudden ischemic events. Summary of the Invention

[0004] The present invention aims to at least partly solve one of the technical problems in the related art. For this purpose, the object of the present invention is to provide a comprehensive therapeutic apparatus for the treatment of coronary heart disease.

[0005] To achieve the above object, according to an embodiment of the present invention, a comprehensive therapeutic apparatus for the treatment of coronary heart disease includes:

[0006] A multimodal sensor module for real-time collection of patient physiological data, where the patient physiological data at least includes heart rate, blood pressure, electrocardiogram, skin conductance response signal, and autonomic nerve signal;

[0007] A control and data processing module, connected to the multi-modal sensor module, is configured to generate dynamic personalized treatment parameters based on an artificial intelligence-based self-learning algorithm according to historical treatment data and the patient's physiological data collected in real time. The treatment parameters include the amplitude of the stimulation current, the pulse frequency, the pulse width, the stimulation period, and the electrical stimulation mode.

[0008] An electrical stimulation execution module, connected to the control and data processing module, is configured to perform electrical stimulation treatment on the patient's cardiac region according to the treatment parameters.

[0009] A communication and remote monitoring module, connected to the control and data processing module, is configured to connect to a monitoring terminal to achieve two-way data communication.

[0010] According to the comprehensive therapeutic apparatus for treating coronary heart disease provided by the embodiments of the present invention, by integrating a multi-modal sensor module, a control and data processing module based on an artificial intelligence self-learning algorithm, an electrical stimulation execution module, and a communication and remote monitoring module, personalized dynamic treatment of patients is achieved. It collects multi-dimensional physiological data such as heart rate, blood pressure, electrocardiogram, skin conductance response signal, and autonomic nerve signal in real time, and uses an artificial intelligence algorithm combined with historical treatment data to generate dynamic personalized treatment parameters, thereby accurately regulating the amplitude of the stimulation current, the pulse frequency, the pulse width, the stimulation period, and the electrical stimulation mode, ensuring that the electrical stimulation treatment can adapt to the immediate changes in the patient's physiological state, further improving the curative effect and reducing the risk of over-stimulation or under-stimulation. At the same time, through two-way data communication with the monitoring terminal, the device realizes remote monitoring and real-time feedback, optimizes patient management, and reduces the treatment lag caused by the defect of fixed parameters, providing a safer, more effective, and intelligent comprehensive treatment method for coronary heart disease patients.

[0011] In addition, the comprehensive therapeutic apparatus for treating coronary heart disease according to the above embodiments of the present invention may further have the following additional technical features:

[0012] According to an embodiment of the present invention, the control and data processing module includes:

[0013] A data preprocessing module, configured to perform filtering, amplification, and normalization processing on the heart rate, blood pressure, electrocardiogram, skin conductance response signal, and autonomic nerve signal respectively, eliminate noise, and output a digitally processed signal.

[0014] A data fusion module, configured to perform multi-parameter fusion on the digitally processed signals to form unified fusion data.

[0015] A self-learning algorithm module, configured to self-update and optimize model parameters based on historical treatment data and the fusion data collected in real time and fusion-processed, and evaluate the patient's current health status to obtain an evaluation result.

[0016] A treatment parameter generation module, configured to automatically calculate and output dynamic personalized treatment parameters for a patient according to the evaluation result generated by the self-learning algorithm module.

[0017] According to an embodiment of the present invention, the control and data processing module further includes an anomaly detection module, configured to perform real-time monitoring on the fused data through an adaptive algorithm, identify abnormal waveforms, sudden changes in heart rate or blood pressure in electrocardiogram, galvanic skin response signals, and autonomic nerve signals, and perform anomaly feedback processing.

[0018] According to an embodiment of the present invention, the anomaly feedback processing includes at least one of local alarm feedback, data logging, notifying a monitoring terminal, and controlling to interrupt the operation of the electrical stimulation execution module.

[0019] According to an embodiment of the present invention, the electrical stimulation execution module includes:

[0020] A pulse generator, which is built with a synchronous sampling and independent channel control circuit and can output multiple stimulation pulses simultaneously;

[0021] A digital control circuit, which is connected to the pulse generator and the control and data processing module, and is used to perform real-time parameter regulation on the electrical stimulation pulses;

[0022] Multiple stimulation electrodes, which are connected to the pulse generator and are used to transmit multiple independent electrical stimulation pulses to the target area of the patient's heart.

[0023] According to an embodiment of the present invention, the pulse generator is a programmable multi-waveform pulse generator, which is used to output electrical stimulation pulses of different waveforms to meet the requirements of the patient for the stimulation form at different pathological stages.

[0024] According to an embodiment of the present invention, the stimulation pulses output by the programmable multi-waveform pulse generator are composite waveform pulses;

[0025] The composite waveform is formed by modulating a basic waveform and a modulation waveform. Among them, the basic waveform includes at least one of a sine wave, a square wave, and a triangular wave, which is used for the stimulation treatment effect, and the modulation waveform is used to change tissue excitability and vasomotor state;

[0026] The composite waveform is at least one of an amplitude - modulated composite wave, a frequency - modulated composite wave, and a phase - modulated composite wave; the amplitude - modulated composite wave is formed by amplitude - modulating a square wave with a frequency range of 80 - 120 Hz by a sine wave whose frequency varies within the range of 2 - 10 Hz; the frequency - modulated composite wave is formed after a high - frequency carrier signal with a fixed amplitude is modulated by a low - frequency signal to generate a frequency change; the phase - modulated composite wave is formed by generating a predetermined interference pattern by changing the phase relationship between adjacent pulses.

[0027] According to an embodiment of the present invention, the multi - modal sensor module includes:

[0028] An electrocardiogram acquisition module for real - time acquisition of the electrocardiogram signal of a patient;

[0029] A heart rate acquisition module for detecting and acquiring the heart rate data of a patient;

[0030] A blood pressure acquisition module for real - time monitoring of the blood pressure value of a patient;

[0031] A galvanic skin response sensing module for acquiring the galvanic skin response signal of a patient;

[0032] An autonomic nerve sensing module for acquiring the nerve signals of the autonomic nervous system of a patient;

[0033] An analog front - end circuit module, which is used to pre - amplify and differentially process the signals obtained from the electrocardiogram acquisition module and the galvanic skin response sensing module to improve the signal - to - noise ratio of the signals;

[0034] An analog multiplexing circuit for sequentially acquiring the signals from the electrocardiogram acquisition module, the heart rate acquisition module, the blood pressure acquisition module, the galvanic skin response sensing module, and the autonomic nerve signal sensing module according to a predetermined polling strategy, and enabling the synchronous acquisition of each signal within a predetermined time.

[0035] According to an embodiment of the present invention, the electrical stimulation execution module further includes an electrode impedance detection module and an alarm prompt module. The electrode impedance detection module is connected to the control and data processing module and is used to detect in real - time the impedance value of the contact between the stimulation electrode and the skin; the alarm prompt module is connected to the digital control circuit;

[0036] The control and data processing module is further used to output a control signal to the digital control circuit when the impedance value exceeds a preset safety range, so as to control the pulse generator to stop the output of the stimulation pulse through the digital control circuit and control the alarm prompt module to output a prompt.

[0037] According to an embodiment of the present invention, the control and data processing module further includes a drug combination therapy module, which is configured to record and analyze the drug information that the patient is using, and adjust the time window and stimulation intensity of the electrical stimulation therapy according to the drug action mechanism and the change law of blood drug concentration.

[0038] Additional aspects and advantages of the present invention will be given in part in the following description, become apparent in part from the following description, or be learned through the practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on the structures shown in these drawings.

[0040] Figure 1 is a block diagram of a comprehensive therapeutic instrument for treating coronary heart disease according to an embodiment of the present invention;

[0041] Figure 2 is a block diagram of the control and data processing module in the comprehensive therapeutic instrument for treating coronary heart disease according to an embodiment of the present invention;

[0042] Figure 3 is a block diagram of the electrical stimulation execution module in the comprehensive therapeutic instrument for treating coronary heart disease according to an embodiment of the present invention;

[0043] Figure 4 is a block diagram of the multi-modal sensor module in the comprehensive therapeutic instrument for treating coronary heart disease according to an embodiment of the present invention.

[0044] Reference Numerals:

[0045] 100, comprehensive therapeutic instrument for treating coronary heart disease;

[0046] 101, multi-modal sensor module; 1011, electrocardiogram acquisition module; 1012, heart rate acquisition module; 1013, blood pressure acquisition module; 1014, skin electrical response sensing module; 1015, autonomic nerve sensing module; 1016, analog multiplexing circuit; 1017, analog front-end circuit module;

[0047] 102, control and data processing module; 1021, data preprocessing module; 1022, data fusion module; 1023, self-learning algorithm module; 1024, treatment parameter generation module; 1025, anomaly detection module; 1026, drug combination therapy module;

[0048] 103. Electrical Stimulation Execution Module; 1031. Pulse Generator; 1032. Digital Control Circuit; 1033. Stimulation Electrode; 1034. Electrode Impedance Detection Module; 1035. Alarm and Prompt Module;

[0049] 104. Communication and Remote Monitoring Module.

[0050] The realization, functional features, and advantages of the present invention will be further described in conjunction with embodiments and with reference to the accompanying drawings. Detailed Embodiment

[0051] The embodiments of the present invention will be described in detail below. The examples of the embodiments are shown in the accompanying drawings, where the same or similar reference numerals represent the same or similar elements or elements with the same or similar functions from beginning to end. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to explain the present invention and should not be construed as a limitation of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0052] The comprehensive therapeutic apparatus 100 for treating coronary heart disease according to an embodiment of the present invention will be described in detail below with reference to the accompanying drawings.

[0053] Refer to Figure 1 As shown, the comprehensive therapeutic apparatus 100 for treating coronary heart disease according to an embodiment of the present invention includes a multimodal sensor module 101, a control and data processing module 102, an electrical stimulation execution module 103, and a communication and remote monitoring module 104.

[0054] Specifically, the multimodal sensor module 101 is used to collect in real time the physiological data of the patient, and the physiological data of the patient at least includes heart rate, blood pressure, electrocardiogram, skin conductance response signal, and autonomic nerve signal. The multimodal sensor module 101 is provided with a plurality of sensing units, which can simultaneously collect key indicators such as heart rate, blood pressure, electrocardiogram, skin conductance response signal, and autonomic nerve signal. These indicators can reflect the changes in the physiological state of the patient and provide a high-quality data source for subsequent processing.

[0055] Among the above physiological data of the patient, heart rate is an important indicator for evaluating cardiac load and compensatory status. Abnormal heart rate (such as tachycardia or bradycardia) may indicate insufficient cardiac blood supply or potential arrhythmia. Blood pressure is directly related to the pumping function of the heart and the state of the vascular system. Hypertension will increase the burden on the coronary arteries, and hypotension may affect myocardial perfusion, thus affecting the stability of the condition. The electrocardiogram records the electrical activity of the heart and can directly reflect pathological changes such as myocardial ischemia and conduction block, providing a basis for timely diagnosis of acute events of coronary heart disease (such as myocardial infarction).

[0056] The skin conductance response signal and the autonomic nerve signal play significant roles in this application. The skin conductance response signal mainly reflects the activities of skin sweat glands, and its changes are often closely related to the state of sympathetic nerve excitation. During a stress state or a pain process, the sympathetic nerve is activated, and the skin conductivity increases accordingly. By monitoring the skin conductance response, the stress response and pain perception changes of the patient can be captured, indicating the possible risk of coronary heart disease attacks. The autonomic nerve signal provides overall information on the autonomous regulation of the heart, including the balance state between the sympathetic nerve and the parasympathetic nerve, and this balance is crucial for maintaining cardiac stability and regulating blood flow distribution. Patients with coronary heart disease usually have autonomic nerve dysfunction, manifested as overactive sympathetic nerve activity or weakened parasympathetic nerve function. This dysfunction may lead to a decrease in heart rate variability and an increase in susceptibility, thereby triggering arrhythmia or exacerbating insufficient cardiac blood supply. By analyzing the autonomic nerve signal in real time, the autonomic nerve state of the patient can be dynamically determined, and then the electrical stimulation parameters can be adjusted to achieve a more precise neuromodulation effect.

[0057] The control and data processing module 102 is connected to the multimodal sensor module 101 and is used to generate dynamic personalized treatment parameters based on an artificial intelligence-based self-learning algorithm according to historical treatment data and the patient physiological data collected in real time. The treatment parameters include the amplitude of the stimulation current, the pulse frequency, the pulse width, the stimulation period, and the electrical stimulation mode.

[0058] That is to say, the control and data processing module 102 uses an artificial intelligence-based self-learning algorithm to analyze and process the historical treatment data and the patient physiological data collected in real time. Specifically, the control and data processing module 102 dynamically generates personalized treatment parameters for each patient by continuously modeling the physiological state change data of the patient individual at different time periods. These treatment parameters include, but are not limited to, the amplitude of the stimulation current, the pulse frequency, the pulse width, the stimulation period, and the electrical stimulation mode. The generation process fully considers the patient's real-time physiological state, historical treatment response, and possible risk factors, so as to ensure that the stimulation plan can achieve the best balance between treatment real-time and safety. The control and data processing module 102 also has a data storage and management function, which can record the data of the entire process of the patient's treatment and provide a reference basis for clinicians.

[0059] The electrical stimulation execution module 103 is connected to the control and data processing module 102 and is used to perform electrical stimulation treatment on the patient's cardiac region according to the treatment parameters. The electrical stimulation execution module 103 can precisely control parameters such as the amplitude, frequency, and width of the output pulse, and at the same time ensure that the stimulation period and mode strictly match the personalized parameters during the treatment process, so as to maximize the treatment effect and reduce adverse reactions that may be caused by parameter mismatch, such as arrhythmia and hypotension.

[0060] The communication and remote monitoring module 104 is connected to the control and data processing module 102 and is used to connect to a monitoring terminal to achieve two-way data communication. Through this communication and remote monitoring module 104, clinicians or remote monitoring centers can obtain the patient's treatment status, historical data, and abnormal warnings in real time for remote diagnosis, parameter adjustment, and maintenance. At the same time, two-way communication between the patient end and the monitoring terminal can also achieve remote feedback and remote guidance, improving the utilization rate of medical resources and the overall treatment management level.

[0061] According to the comprehensive therapeutic apparatus 100 for treating coronary heart disease provided by an embodiment of the present invention, by integrating a multi-modal sensor module 101, a control and data processing module 102 based on an artificial intelligence self-learning algorithm, an electrical stimulation execution module 103, and a communication and remote monitoring module 104, personalized dynamic treatment of patients is achieved. It collects multi-dimensional physiological data such as heart rate, blood pressure, electrocardiogram, skin conductance response signal, and autonomic nerve signal in real time, and uses artificial intelligence algorithms combined with historical treatment data to generate dynamic personalized treatment parameters, thereby accurately regulating the amplitude of the stimulation current, pulse frequency, pulse width, stimulation period, and electrical stimulation mode to ensure that the electrical stimulation treatment can adapt to the immediate changes in the patient's physiological state, further improving the curative effect and reducing the risk of over-stimulation or under-stimulation. At the same time, through two-way data communication with the monitoring terminal, the device realizes remote monitoring and real-time feedback, optimizes patient management, and reduces the treatment lag caused by the defect of fixed parameters, providing a safer, more effective, and intelligent comprehensive treatment method for coronary heart disease patients.

[0062] Refer to Figure 2 As shown, in some embodiments of the present invention, the control and data processing module 102 includes a data preprocessing module 1021, a data fusion module 1022, a self-learning algorithm module 1023, and a treatment parameter generation module 1024.

[0063] Specifically, the data preprocessing module 1021 is used to perform filtering, amplification, and normalization processing on the heart rate, blood pressure, electrocardiogram, skin conductance response signal, and autonomic nerve signal respectively to eliminate noise and output a digitally processed signal. Exemplarily, first, the environmental and instrument noise in the signal is eliminated through a filter; then, the weak signal is enhanced through an amplifier to ensure that the signal amplitude reaches a predetermined range; subsequently, through normalization processing, signals of different types and magnitudes are unified in scale, and a standardized digitally processed signal is output to ensure comparability and consistency between data.

[0064] The data fusion module 1022 is used to perform multi-parameter fusion on the digitized processing signals to form unified fusion data. This data fusion module 1022 adopts a data fusion algorithm to perform collaborative analysis on signals from different sensors in terms of time series and features, obtaining a unified fusion data set. This fusion data not only retains the important features of each individual physiological parameter but also reveals the internal relationships between them, providing comprehensive and accurate data input for the subsequent self-learning algorithm module 1023.

[0065] The self-learning algorithm module 1023 is used to self-update and optimize model parameters based on historical treatment data and the fusion data obtained from real-time acquisition and fusion processing, and evaluate the current health status of the patient to obtain an evaluation result. This self-learning algorithm module 1023 uses an algorithm based on a neural network to perform real-time analysis and dynamic modeling on the fusion data. By continuously collecting and learning the patient's historical treatment data and real-time fusion data, it continuously updates and optimizes the model parameters of the neural network. Through feature extraction and pattern recognition, the self-learning algorithm module 1023 can accurately evaluate the current health status and autonomic nerve balance state of the patient, and identify potential risks. This data-driven evaluation method enables the model to have the ability of self-optimization and can continuously improve the accuracy of evaluation over time.

[0066] The treatment parameter generation module 1024 is used to automatically calculate and output dynamic personalized treatment parameters for the patient according to the evaluation result generated by the self-learning algorithm module 1023. This treatment parameter generation module 1024 automatically calculates and outputs dynamic personalized treatment parameters according to the evaluation result output by the self-learning algorithm module 1023, in combination with built-in treatment strategies and mathematical models. The generated treatment parameters include the amplitude of the stimulation current, pulse frequency, pulse width, stimulation period, and electrical stimulation mode, and these parameters can be transmitted in real time to the electrical stimulation execution module 103 for performing precise electrical stimulation treatment on the patient's heart area, realizing the adaptive adjustment of the treatment plan.

[0067] Through the collaborative action of the four modules of data preprocessing, data fusion, self-learning algorithm, and treatment parameter generation, this embodiment realizes the efficient processing and fusion analysis of multi-dimensional physiological data such as heart rate, blood pressure, electrocardiogram, skin electrical response signal, and autonomic nerve signal. It can continuously self-learn and optimize the model according to historical data, realize the accurate evaluation of the patient's health status, and generate dynamic personalized treatment parameters in real time. Thus, this comprehensive treatment instrument 100 can significantly improve the accuracy and safety of the electrical stimulation treatment for coronary heart disease, overcoming the limitations of the traditional fixed-parameter scheme.

[0068] In one embodiment of the present invention, the control and data processing module 102 further includes an anomaly detection module 1025, which is used to perform real-time monitoring on the fused data through an adaptive algorithm, identify abnormal waveforms, sudden changes in heart rate or blood pressure in electrocardiogram, galvanic skin response signal, and autonomic nerve signal, and perform anomaly feedback processing.

[0069] Based on the fused data output by the data fusion module 1022, the anomaly detection module 1025 deeply analyzes key signals using an adaptive algorithm, focusing on detecting abnormal waveforms that may appear in electrocardiogram, galvanic skin response signal, and autonomic nerve signal, as well as sudden changes in heart rate or blood pressure. Specifically, the anomaly detection module 1025 first performs real-time segmentation processing on the fused data, divides the data into continuous time segments, and uses the sliding window technique to statistically calculate and calculate indexes such as waveform features, amplitude, and frequency within each data segment; subsequently, an adaptive algorithm is used to automatically establish a normal fluctuation range model, and each data segment is compared based on this benchmark. When abnormal rhythms, ST segment abnormalities or suppression phenomena appear in the electrocardiogram, or the galvanic skin response signal shows too high or too low conductance changes, and the autonomic nerve signal shows imbalance or violent fluctuations, these abnormal waveforms will be automatically identified and marked. At the same time, for sudden changes in heart rate or blood pressure, the change rate will be monitored in real time. Once a sudden change exceeding the preset threshold is detected, corresponding anomaly feedback processing measures will be immediately triggered.

[0070] By introducing the anomaly detection module 1025, this embodiment realizes real-time monitoring and accurate determination of abnormal waveforms of key physiological signals and sudden changes in heart rate and blood pressure in the fused data, significantly enhancing the dynamic perception ability of the patient's physiological state. It can not only timely identify and feedback possible abnormal changes to ensure treatment safety, but also form a closed-loop control with subsequent treatment parameter adjustment, effectively reducing the risk of emergencies.

[0071] Exemplarily, the anomaly feedback processing includes at least one of local alarm feedback, data logging, notifying the monitoring terminal, and controlling the interruption of the operation of the electrical stimulation execution module 103.

[0072] Local alarm feedback: The anomaly detection module 1025 triggers a local alarm, and this alarm displays abnormal warning information through a graphical interface, an audible and visual alarm device, etc., so that the operator can confirm and take measures in time.

[0073] Data logging: The anomaly detection module 1025 records information such as abnormal data, abnormal occurrence time, and abnormal type in the local memory to form a data log, and provides updated statistical data and parameter optimization basis for the subsequent self-learning algorithm module 1023.

[0074] Remote communication and early warning: The anomaly detection module 1025 automatically reports anomalies to the monitoring terminal or cloud platform through the communication and remote monitoring module 104 to notify remote doctors or experts. After receiving the information, the monitoring terminal can further re-evaluate the patient's condition through a processing flow and guide on-site operators or automatically adjust the treatment plan.

[0075] Automatic interruption handling measures: At the same time as detecting an anomaly, the self-learning algorithm sub-module will automatically interrupt the operation of the electrical stimulation execution module 103 according to pre-set safety thresholds and processing logics to ensure that the treatment can be quickly paused in case of an anomaly, so as to avoid potential risks to the patient.

[0076] Refer to Figure 3 As shown, in an embodiment of the present invention, the electrical stimulation execution module 103 includes a pulse generator 1031, a digital control circuit 1032, and multiple stimulation electrodes 1033.

[0077] The pulse generator 1031 is built with a synchronous sampling and independent channel control circuit and can output multiple stimulation pulses simultaneously. This pulse generator 1031 can coordinate the delivery of multiple output channels in a short time, effectively supporting the zonal and multi-point treatment of the patient's cardiac target area, and improving the flexibility and refinement level of the treatment plan.

[0078] The digital control circuit 1032 is connected to the pulse generator 1031 and the control and data processing module 102 to perform real-time parameter regulation on the electrical stimulation pulses. After receiving the treatment parameters from the control and data processing module, the digital control circuit 1032 immediately transmits the corresponding instructions to each independent output channel to complete parameter allocation and synchronous adjustment.

[0079] The multiple stimulation electrodes 1033 are connected to the pulse generator 1031 and are used to transmit multiple independent electrical stimulation pulses to the patient's cardiac target area. Each stimulation electrode 1033 can receive independently controlled electrical stimulation pulses from the pulse generator 1031 and accurately apply them to the patient according to pre-set dynamic parameters to achieve the purpose of effectively regulating myocardial electrical activity. In addition, the stimulation electrodes 1033 are all made of medical-grade conductive materials to ensure excellent electrical conductivity and biocompatibility during long-term use, while minimizing the risk of skin or myocardial damage that may be caused by long-term contact.

[0080] The electrical stimulation execution module 103 of this embodiment realizes fine parameter regulation during the electrical stimulation treatment process through the pulse generator 1031, the digital control circuit 1032, and the stimulation electrodes 1033. By using the synchronous sampling and independent channel control circuit, the multiple output channels can work in coordination, while the digital control circuit 1032 ensures the rapid response and accurate distribution of various treatment parameters.

[0081] In one embodiment of the present invention, the pulse generator 1031 is a programmable multi-waveform pulse generator 1031, which is used to output electrical stimulation pulses of different waveforms to meet the patient's requirements for the stimulation pattern at different pathological stages.

[0082] Specifically, the pulse generator 1031 can use a high-speed digital-to-analog converter (DAC) to convert digital control signals into precise analog waveforms, and at the same time use a multi-stage amplifier to ensure that the output electrical stimulation pulses have sufficient driving power and stability. The design of independent channels enables multiple electrical stimulation pulse outputs to work simultaneously, and each channel can be independently programmed to achieve simultaneous output of different waveforms during multi-point electrical stimulation.

[0083] The programmable multi-waveform pulse generator 1031 in this embodiment realizes precise programming and real-time regulation of various electrical stimulation pulse waveforms. It can not only meet the personalized needs of patients at different pathological stages for electrical stimulation waveforms, but also ensure the stability and safety of pulse output through a monitoring and adaptive adjustment mechanism, thereby significantly improving the treatment effect and reducing potential risks.

[0084] In one example of the present invention, the stimulation pulse output by the programmable multi-waveform pulse generator 1031 is a composite waveform pulse. This composite waveform is formed by modulating a basic waveform and a modulation waveform, where the basic waveform includes at least one of a sine wave, a square wave, and a triangular wave and is used for the stimulation treatment effect, and the modulation waveform is used to change the tissue excitability and vasomotor state.

[0085] Preferably, the composite waveform is at least one of an amplitude modulation composite wave, a frequency modulation composite wave, and a phase modulation composite wave, and each modulation method has different regulation effects and technical advantages.

[0086] The amplitude modulation composite wave is formed by amplitude-modulating a square wave of 80 - 120 Hz with a sine wave whose frequency varies in the range of 2 - 10 Hz. Specifically, the high-frequency square wave serves as a carrier to provide a stable stimulation frequency and energy, while the low-frequency sine wave dynamically adjusts the amplitude of the square wave, making the output electrical stimulation pulse exhibit a periodically changing stimulation intensity during the treatment process. This modulation method can not only achieve stable stimulation of nerve cells, but also affect the local microcirculation and vasomotor state through the modulation effect, thereby obtaining a more precise treatment effect.

[0087] The frequency - modulated composite wave is formed by modulating a high - frequency carrier signal with a fixed amplitude by a low - frequency signal to produce a frequency change. In specific implementation, a high - frequency carrier with a fixed frequency and a fixed amplitude is first generated. After being regulated by the low - frequency modulation signal, the output frequency of this carrier changes continuously or in segments over time, thereby achieving precise regulation of the excitation state of the target tissue. The modulation effect of the low - frequency signal enables the overall stimulation waveform to have a certain dynamic adjustment ability in terms of frequency to adapt to the uncertainty of the tissue's response to electrical stimulation under different pathological conditions.

[0088] The phase - modulated composite wave is formed by generating a predetermined interference pattern by changing the phase relationship between adjacent pulses. While generating the basic waveform, the phase parameters of each pulse are precisely adjusted through digital control, so that there is a specific phase difference between adjacent pulses. This phase difference causes an interference effect in the output waveform in space or time, thereby further improving the uniformity and pertinence of the stimulation effect. In this way, the risk of local over - stimulation or under - stimulation can be effectively reduced, and a more optimized treatment effect can be achieved.

[0089] In this embodiment, the programmable multi - waveform pulse generator 1031 combines the basic waveform with the modulation waveform by outputting a composite - waveform pulse, and precisely controls each parameter of the stimulation pulse by using amplitude, frequency, and phase modulation methods respectively. This composite - waveform pulse not only ensures an effective excitation effect on the tissue, but also further realizes precise regulation of the tissue excitability and vasomotor state by using the low - frequency modulation signal to change its amplitude, frequency, and phase parameters.

[0090] Refer to Figure 4 As shown, in an embodiment of the present invention, the multi - modal sensor module 101 includes an electrocardiogram acquisition module 1011, a heart rate acquisition module 1012, a blood pressure acquisition module 1013, a skin electro - response sensing module 1014, an autonomic nerve sensing module 1015, an analog front - end circuit module 1017, and an analog multiplexing circuit 1016.

[0091] The electrocardiogram acquisition module 1011 is used to acquire the electrocardiogram signal of the patient in real time; the heart rate acquisition module 1012 is used to detect and acquire the heart rate data of the patient; the blood pressure acquisition module 1013 is used to monitor the blood pressure value of the patient in real time; the skin electro - response sensing module 1014 is used to acquire the skin electro - response signal of the patient; the autonomic nerve sensing module 1015 is used to acquire the nerve signal of the patient's autonomic nervous system.

[0092] The analog front - end circuit module 1017 is used to pre - amplify and perform differential processing on the signals obtained from the electrocardiogram acquisition module 1011 and the skin electro - response sensing module 1014 to improve the signal - to - noise ratio of the signals.

[0093] The analog multiplexing circuit 1016 is used to sequentially collect signals from the electrocardiogram acquisition module 1011, heart rate acquisition module 1012, blood pressure acquisition module 1013, skin conductance response sensing module 1014, and autonomic nerve signal sensing module according to a predetermined polling strategy, and synchronously collect each signal within a predetermined time.

[0094] In this embodiment, in order to ensure the quality and stability of signal acquisition, the analog front-end circuit module 1017 is used to perform pre-amplification and differential processing operations on the weak signals obtained from the electrocardiogram acquisition module 1011 and the skin conductance response sensing module 1014. The pre-amplification process can effectively enhance the low-amplitude signals to reach the amplitude range required for subsequent digital processing; the differential processing can effectively suppress the common-mode interference and improve the signal-to-noise ratio of the signals, thereby ensuring the accuracy of signal processing and the reliability of subsequent data fusion processing.

[0095] In order to achieve synchronous acquisition of multiple physiological signals and improve the overall data acquisition efficiency, the analog multiplexing circuit 1016 is used to sequentially collect information from each sensing module (including electrocardiogram, heart rate, blood pressure, skin conductance response, and autonomic nerve signals) according to a predetermined polling strategy, and ensure synchronous acquisition of multiple signals within a set time slice. Through this synchronization mechanism, good timing consistency can be ensured between different signals, providing a unified and accurate time reference for data fusion and subsequent self-learning algorithms, and effectively avoiding system errors introduced by data delay or asynchronous acquisition.

[0096] Refer to Figure 3 As shown, in an embodiment of the present invention, the electrical stimulation execution module 103 further includes an electrode impedance detection module 1034 and an alarm prompt module 1035. The electrode impedance detection module 1034 is connected to the control and data processing module 102 and is used to detect the impedance value of the contact between the stimulation electrode 1033 and the skin in real time; the alarm prompt module 1035 is connected to the digital control circuit 1032.

[0097] The control and data processing module 102 is further used to output a control signal to the digital control circuit 1032 when the impedance value exceeds a preset safety range, so as to control the pulse generator 1031 to stop the output of the stimulation pulse through the digital control circuit 1032, and control the alarm prompt module 1035 to output a prompt.

[0098] In this embodiment, the electrode impedance detection module 1034 is used to monitor in real time the contact impedance value between the stimulation electrode 1033 installed on the patient's body surface and the skin, can continuously sample and numerically feedback the impedance at the interface between the stimulation electrode 1033 and the skin, and transmit the real-time detection result to the control and data processing module 102 for data analysis and judgment.

[0099] When the control and data processing module 102 receives the impedance data transmitted back by the electrode impedance detection module 1034, it performs real-time comparison of the data against a pre-set safety threshold internally. If it is detected that the impedance value of the stimulation electrode 1033 in contact with the skin exceeds the pre-set safety range, it is immediately determined as an abnormal state. At this time, the control and data processing module 102 outputs a control signal to the digital control circuit 1032, and the digital control circuit 1032 quickly stops the stimulation pulse output of the pulse generator 1031 according to the signal instruction, thereby interrupting the electrical stimulation treatment of the patient, avoiding continued application of electrical stimulation under poor contact conditions, and preventing local stimulation abnormalities or patient discomfort caused by poor contact.

[0100] Meanwhile, when an abnormal state is detected and the pulse output is interrupted, the digital control circuit 1032 sends an instruction to the alarm and prompt module 1035. The alarm and prompt module 1035 outputs an alarm message in a visual or auditory manner according to the received instruction, providing a timely abnormal prompt for the operator. This alarm not only indicates that the current electrode contact condition is abnormal, but also displays the specific impedance value information and abnormal prompt on the device display interface, supplemented by an audio warning signal to remind medical staff to immediately check the contact condition between the electrode and the skin or take corresponding repair measures to ensure patient safety. In this way, the safety and reliability of the therapeutic instrument are further improved.

[0101] Refer to Figure 2 As shown, in an embodiment of the present invention, the control and data processing module 102 further includes a drug co-therapy module 1026, which is used to record and analyze the drug information being used by the patient, and adjust the time window and stimulation intensity of the electrical stimulation treatment according to the drug action mechanism and the change law of blood drug concentration.

[0102] Specifically, the drug co-therapy module 1026 is connected to the data interface of the patient information management system, and obtains the existing drug types, doses, medication cycles, and dynamic action information of the drug of the patient in real time from the patient's medical record, electronic medical record, or direct input.

[0103] The control and data processing module 102 has multiple databases, including a drug action mechanism library, a blood drug concentration dynamic model library, and a historical treatment data database. First, the drug information used by the patient is classified, stored, and a corresponding digital model is established to ensure the timeliness and integrity of all input data. Then, using the drug action mechanism library, parameters such as drug molecule interaction, receptor binding efficiency, metabolic pathway, and half-life are used to comprehensively evaluate the duration and intensity of the physiological effect of the drug in the patient's body. At the same time, the blood drug concentration dynamic model library predicts and real-time updates the change curve of blood drug concentration within a predetermined time period after the patient takes the drug based on the drug release, absorption, distribution, metabolism, and excretion models.

[0104] After obtaining the above drug information and blood drug concentration change data, the drug combination therapy module 1026 conducts in-depth data comparison and fusion with the self-learning algorithm module 1023, and comprehensively analyzes the drug action effect and the patient's real-time physiological data (such as heart rate, electrocardiogram, blood pressure, etc.). Through this process, it can not only identify in real time the impact of possible synergistic or antagonistic effects of drugs on cardiac function, but also dynamically adjust the key parameters of electrostimulation therapy according to the patient's current physiological state and drug concentration. In addition, based on the predicted peak or stable period of blood drug concentration, the implementation time period of stimulation is automatically optimized to ensure the synergy between electrostimulation and the best drug efficacy period. And according to the impact of drugs on the excitability or inhibitory effect of myocardial cells, the amplitude and pulse width of the stimulation current are adjusted to avoid adverse reactions caused by the dual effects of drugs and electrostimulation.

[0105] In this embodiment, the drug combination therapy module 1026 realizes the synergistic effect between drugs and electrostimulation by recording and analyzing the patient's drug information and blood drug concentration changes in real time, and dynamically adjusting the time window and stimulation intensity of electrostimulation therapy according to the drug action mechanism, making the treatment effect more accurate and safe, and effectively improving the clinical application effect of the overall treatment.

[0106] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "comprising a..." does not exclude the presence of additional identical elements in the process, method, article or device comprising the element.

[0107] The steps of the methods or algorithms described in connection with the embodiments disclosed herein can be implemented directly in hardware, software modules executed by a processor, or a combination of both. The software modules can be placed in a random access memory (RAM), memory, read-only memory (ROM), electrically programmable ROM, electrically erasable programmable ROM, registers, hard disk, removable disk, CD-ROM, or any other form of storage medium well known in the technical field.

[0108] In the description of this specification, the descriptions referring to terms such as "one embodiment", "some embodiments", "examples", "specific examples", or "some examples", etc., mean that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0109] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A comprehensive therapeutic device for treating coronary heart disease, characterized in that: include: A multimodal sensor module, used for real-time acquisition of patient physiological data, including at least heart rate, blood pressure, electrocardiogram, galvanic skin response signal and autonomic nerve signal; A control and data processing module, connected to the multimodal sensor module, for generating dynamic personalized treatment parameters based on the artificial intelligence self-learning algorithm according to the historical treatment data and the patient's physiological data collected in real time, wherein the treatment parameters include stimulation current amplitude, pulse frequency, pulse width, stimulation cycle and electrical stimulation mode; an electrical stimulation execution module, connected to the control and data processing module, and configured to perform electrical stimulation treatment on the patient's heart area according to the treatment parameters; The communication and remote monitoring module is connected to the control and data processing module and is used to connect to the monitoring terminal to achieve two-way data communication.

2. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 1, characterized in that: The control and data processing module includes: The data preprocessing module is used to filter, amplify and normalize the heart rate, blood pressure, electrocardiogram, skin galvanic response signal and autonomic nerve signal, eliminate noise and output digital processing signals; A data fusion module, used for fusing the digital processed signals with multiple parameters to form unified fused data; The self-learning algorithm module is used to self-update and optimize model parameters through the neural network algorithm based on historical treatment data and fusion data collected in real time and processed, and evaluate the patient's current health status to obtain evaluation results; The treatment parameter generation module is used to automatically calculate and output dynamic personalized treatment parameters for the patient based on the evaluation results generated by the self-learning algorithm module.

3. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 2, characterized in that: The control and data processing module also includes an abnormality detection module, which is used to monitor the fused data in real time through an adaptive algorithm, identify abnormal waveforms in the electrocardiogram, skin electrical response signals, and autonomic nerve signals, and sudden changes in heart rate or blood pressure, and perform abnormal feedback processing.

4. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 3, characterized in that: The abnormal feedback processing includes at least one of local alarm feedback, data log recording, notification of a monitoring terminal, and control interruption of the operation of the electrical stimulation execution module.

5. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 1, characterized in that: The electrical stimulation execution module comprises: A pulse generator, wherein the pulse generator has a built-in synchronous sampling and independent channel control circuit, and can output multiple stimulation pulses simultaneously; A digital control circuit, which is connected to the pulse generator and the control and data processing module, and is used to perform real-time parameter control on the electrical stimulation pulse; A plurality of stimulation electrodes are connected to the pulse generator and are used to deliver a plurality of independent electrical stimulation pulses to a target area of ​​the patient's heart.

6. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 5, characterized in that: The pulse generator is a programmable multi-waveform pulse generator, which is used to output electrical stimulation pulses with different waveforms to meet the patient's needs for stimulation forms at different pathological stages.

7. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 6, characterized in that: The stimulation pulse output by the programmable multi-waveform pulse generator is a composite waveform pulse; The composite waveform is formed by modulation of a basic waveform and a modulated waveform, wherein the basic waveform includes at least one of a sine wave, a square wave, and a triangle wave for stimulating therapeutic effects, and the modulated waveform is used to change tissue excitability and vasoconstriction state; The composite waveform is at least one of an amplitude modulated composite wave, a frequency modulated composite wave and a phase modulated composite wave; the amplitude modulated composite wave is formed by amplitude modulating a square wave of 80-120 Hz by a sine wave whose frequency varies in the range of 2-10 Hz; the frequency modulated composite wave is formed by modulating a high-frequency carrier signal with a fixed amplitude by a low-frequency signal to produce a frequency change; the phase modulated composite wave is formed by generating a predetermined interference pattern by changing the phase relationship between adjacent pulses.

8. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 1, characterized in that: The multimodal sensor module comprises: Electrocardiogram acquisition module, used to collect the patient's electrocardiogram signal in real time; Heart rate collection module, used to detect and collect the patient's heart rate data; Blood pressure collection module, used to monitor the patient's blood pressure value in real time; A skin galvanic response sensor module is used to collect the patient's skin galvanic response signal; An autonomic nerve sensor module is used to collect nerve signals from the patient's autonomic nervous system; An analog front-end circuit module, which is used to pre-amplify and differentially process the signals obtained from the electrocardiogram acquisition module and the skin galvanic response sensing module to improve the signal-to-noise ratio of the signals; The analog multiplexing circuit is used to collect signals from the electrocardiogram acquisition module, the heart rate acquisition module, the blood pressure acquisition module, the skin electrical response sensor module and the autonomic nerve signal sensor module in sequence according to a predetermined polling strategy, and to synchronize the acquisition of each signal within a predetermined time.

9. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 5, characterized in that: The electrical stimulation execution module also includes an electrode impedance detection module and an alarm prompt module. The electrode impedance detection module is connected to the control and data processing module and is used to detect the impedance value of the stimulation electrode in contact with the skin in real time; the alarm prompt module is connected to the digital control circuit; The control and data processing module is also used to output a control signal to the digital control circuit when the impedance value exceeds a preset safety range, so as to control the pulse generator to stop outputting the stimulation pulse through the digital control circuit, and control the alarm prompt module to output a prompt.

10. The comprehensive therapeutic apparatus for treating coronary heart disease according to claim 2, characterized in that: The control and data processing module also includes a drug synergistic treatment module, which is used to record and analyze the information of the drugs currently being used by the patient, and adjust the time window and stimulation intensity of the electrical stimulation treatment according to the drug action mechanism and the change law of blood drug concentration.

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