Integrated defibrillation cardiac contractility adjusting system

Abstract

The invention relates to the technical field of implantable medical electronic instruments, and discloses an integrated defibrillable cardiac contraction force adjusting system which comprises a signal acquisition end, a rhythm analysis end, a treatment execution end, a cooperative control end and an energy management end. A closed-loop treatment system of rhythm perception-systole enhancement-defibrillation protection is formed, and the system aims at solving the dual problems of sudden death risk and progressive heart function deterioration faced by chronic heart failure patients for a long time through three cooperative mechanisms of real-time monitoring of myocardial electrical activity, intelligent adjustment of heart blood pumping capacity and instantaneous intervention of fatal arrhythmia. The system improves the signal fidelity, and has the technical feature associated clinical values of energy dynamic compensation, a remote early warning mechanism and a time division multiplexing architecture.

Description

Technical Field

[0001] The present invention relates to the technical field of implantable medical electronic devices, in particular to an integrated defibrillable cardiac contractility regulating system. Background Art

[0002] Implantable medical electronic device technology refers to a comprehensive approach in which devices containing electronic components are surgically implanted completely or partially into the human body to replace, repair, or enhance the function of human organs, providing real-time monitoring and treatment. These devices rely on external energy sources such as electricity and require long-term retention and absorption within the body. The integrated defibrillator-enabled cardiac contractility regulation system is a breakthrough treatment for patients with severe heart failure and malignant arrhythmias. Its core value lies in the deep integration of cardiac contractility regulation with implantable defibrillator functions, forming a closed-loop treatment system of "rhythm sensing-contraction enhancement-defibrillation protection." Through three synergistic mechanisms: real-time monitoring of myocardial electrical activity, intelligent regulation of the heart's pumping capacity, and instantaneous intervention for life-threatening arrhythmias, this system aims to address the dual challenges of sudden death and progressive cardiac deterioration that chronic heart failure patients face. As the most advanced integrated technology for modern cardiac implantable electronic devices, its performance is directly linked to the approximately 68% improvement in the five-year survival rate for patients with ischemic cardiomyopathy and dilated cardiomyopathy, making it a key research area in the cardiovascular device field.

[0003] The current clinical application of the separation treatment program has three serious defects: signal distortion caused by the mixed treatment environment: when the heart electrodes collect ECG signals and local excitation signals at the same time, the electromagnetic interference generated by high-voltage defibrillation will forcibly cover the microvolt-level bioelectric signals. This phenomenon causes up to 93% of cases to have local signal amplitude attenuation of more than 60% after surgery, resulting in misjudgment of the myocardial excitation state and directly causing treatment delays. For example, during ventricular fibrillation, the average recognition delay caused by signal distortion is 8.4 seconds, far exceeding the clinical safety threshold of 5 seconds; timing disorder caused by functional execution conflict: if the cardiac contractility regulation stimulation pulse overlaps with the onset time of ventricular fibrillation, it will reduce the stability of the myocardial cell membrane potential and reduce the success rate of ventricular defibrillation. More seriously, Continuous stimulation during the myocardial refractory period after a defibrillation shock can induce iatrogenic ventricular tachycardia. FDA data show that such events lead to a relatively increased mortality rate in patients. The fundamental problem is that the existing system completely lacks dynamic coordinated control of the stimulation pulse refractory period and the defibrillation recovery period, and the treatment regimen has been rigidified, resulting in a degradation of efficacy: the current device operates in a mechanical preset parameter mode: a fixed stimulation window is set 200 milliseconds after the QRS wave, resulting in ineffective treatment for 42% of patients with delayed ventricular mechanical contraction. The standard regimen of 35 joules of defibrillation energy is uniformly adopted, resulting in myocardial burns in 61% of low-weight patients. The lack of a real-time feedback regulation mechanism makes it impossible to respond to acute hemodynamic changes in a timely manner, resulting in the CCM efficacy being nearly halved 18 months after surgery.

[0004] Therefore, the present invention provides an integrated defibrillable cardiac contractility regulation system to solve the above-mentioned problems. Summary of the Invention

[0005] (1) Technical problems solved

[0006] In view of the deficiencies of the prior art, the present invention provides an integrated defibrillable cardiac contractility regulation system, which solves the problems raised in the above-mentioned background technology.

[0007] (2) Technical solution

[0008] To achieve the above objectives, the present invention provides the following technical solutions: an integrated defibrillable cardiac contractility regulation system, the system comprising the following steps:

[0009] S1, collecting ECG signals and local myocardial excitation signals in real time through an electrode array implanted in the heart, wherein the electrode array includes two stimulation electrodes and one defibrillation electrode;

[0010] S2. Analyze and process cardiac activity status based on the electrocardiogram signal and the local myocardial excitation signal to generate cardiac rhythm characteristic data and local excitation event time series data;

[0011] S3, performing arrhythmia type identification processing based on the cardiac rhythm characteristic data to generate a cardiac rhythm abnormality judgment result; when ventricular fibrillation is identified, executing step S7;

[0012] S4. When the cardiac rhythm is normal, performing cardiac contractility adjustment timing calculation based on the local excitation event timing data to generate stimulation triggering window data;

[0013] S5. Applying a cardiac contractility modulation pulse within the stimulation triggering window, wherein the stimulation triggering window is defined as a time interval of 20 ms after the occurrence of a local excitation event;

[0014] S6. Real-time monitoring of cardiac mechanical contraction response data, and dynamic adjustment of stimulation pulse parameters based on contraction response feedback;

[0015] S7. When ventricular fibrillation is detected, charging of the high-voltage capacitor is initiated and a defibrillation shock is applied, wherein the defibrillation shock energy is 25 joules.

[0016] S8. Perform cardiac rhythm recovery monitoring after the defibrillation shock is completed, and return to step S1 when sinus rhythm is detected.

[0017] Preferably, the S1 includes:

[0018] S11, collecting local myocardial bipolar signals through electrodes 1 and 2 in the electrode array;

[0019] S12, collecting global ECG signals through defibrillation electrodes;

[0020] S13. Perform noise filtering on the bipolar signal and the global ECG signal based on a wavelet transform algorithm to generate a local excitation signal and an ECG signal after noise reduction.

[0021] Preferably, the S2 includes:

[0022] S21, extracting RR interval variability and ST segment deviation characteristics of the electrocardiogram signal to generate cardiac rhythm feature data;

[0023] S22, detecting the time of occurrence of the local excitation event by using the maximum value of dv / dt of the local excitation signal;

[0024] S23. Construct a temporal mapping relationship between local excitation events and R waves of the electrocardiogram signal to generate an event correlation matrix.

[0025] Preferably, the S4 includes:

[0026] S41. Calculate the effective refractory period (ERP) based on the time when the local excitation event occurs;

[0027] S42. Optimize the stimulus trigger window based on the dynamic time warping algorithm. The window calculation formula is:

[0028]

[0029] in, is the starting point of the optimized stimulation window, is the time anchor point of the R wave peak, is the contraction force adjustment gain coefficient, is the electrophysiological adaptation coefficient, is the ventricular fibrillation avoidance factor, is the dynamic time warping deviation, is the dynamic heart rate cycle, is the real-time ECG vector, is a personalized benchmark template, is the standard deviation of heart rate variability, ∈[5,20]ms dynamic adjustment amount.

[0030] Preferably, the S5 includes:

[0031] S51, generating a bi-phase symmetrical stimulation pulse within the stimulation trigger window, wherein the pulse parameters include: amplitude: 6V, pulse width: 40ms, frequency: 60ppm;

[0032] S52. Apply stimulation pulses through selected stimulation electrodes in the electrode array, where the electrode selection is based on optimization of the local signal-to-noise ratio.

[0033] Preferably, the S7 includes:

[0034] S71. When ventricular fibrillation lasts for more than 3 seconds, the high-voltage charging circuit is activated;

[0035] S72. Use impedance compensation algorithm to adjust defibrillation energy:

[0036]

[0037] in, is the energy after impedance compensation, As the basic energy setting, is the dynamic impedance offset, is the impedance sensitive gain, is the dielectric attenuation index, is the tissue penetration coefficient, To compensate for the attenuation factor, is the thoracic composite impedance.

[0038] Preferably, the S6 includes:

[0039] S61, collecting apex beat signals through an acceleration sensor;

[0040] S62. Calculate the contractility enhancement index:

[0041]

[0042] in, is the contractility enhancement index, is the baseline heart rate amplitude, is the heart rate amplitude after treatment;

[0043] S63, when the contraction force enhancement index When it is less than 15%, increase the stimulus by 10%.

[0044] Preferably, a safety protection mechanism is also included:

[0045] S81. Pause all stimulation pulse output 50ms before defibrillation shock.

[0046] S82. Establish a stimulation-defibrillation mutually exclusive timing controller to ensure that the minimum time interval is greater than 500 ms;

[0047] S83. When defibrillation is triggered more than 3 times within 24 hours, remote medical warning will be activated.

[0048] Preferably, the following security optimization steps are added after step S6:

[0049] S9. Monitor the synchronization between the stimulation pulse and the cardiac autonomic rhythm in real time. When the pulse is detected to fall on the rising branch of the T wave, immediately execute:

[0050] S91, pausing the current stimulation pulse output;

[0051] S92, recalculate the ERP value and update the stimulus trigger window;

[0052] S93, resuming stimulation pulse output within the updated window;

[0053] S94. Record abnormal events and generate security logs.

[0054] Preferably, the following enhanced recovery step is added in step S8:

[0055] S10. After recovery monitoring confirms sinus rhythm, perform the graded stimulation recovery procedure:

[0056] S101, in the first stage, a CCM pulse of 50% of the basic intensity is applied;

[0057] S102, continuously monitoring cardiac contraction response data for more than 5 cardiac cycles;

[0058] S103, if the contraction force enhancement index greater than 12%, gradually increase the stimulation intensity to 100%;

[0059] S104, if the contraction force enhancement index Less than 12%, maintain current intensity and activate telemedicine alert.

[0060] (3) Beneficial effects

[0061] Compared with the prior art, the present invention provides an integrated defibrillable cardiac contractility regulation system, which belongs to the technical field of implantable medical electronic devices, and specifically relates to an integrated defibrillable cardiac contractility regulation system, and has the following beneficial effects:

[0062] 1. This invention utilizes an innovatively designed signal acquisition terminal and a co-integrated electrode array with adaptive filtering technology during real-time monitoring of cardiac electrophysiological signals, effectively addressing the signal crosstalk problem caused by spatial separation of electrodes in traditional devices. Specifically, the coordinated layout of platinum-iridium alloy stimulation electrodes and titanium nitride defibrillation electrodes improves the signal-to-noise ratio of local myocardial microvolt-level signal acquisition. A wavelet transform algorithm eliminates electromagnetic interference generated by high-voltage defibrillation in real time, reducing the signal distortion rate of traditional technologies. An implantable motion sensor simultaneously captures mechanical contraction signals, enabling the system to accurately identify the temporal relationship between myocardial excitation events and mechanical contractions. Clinical value: Postoperative follow-up data show that this technology reduces the incidence of treatment delays due to signal distortion, improving the accuracy of arrhythmia identification and the timeliness of treatment in heart failure patients.

[0063] 2. This invention, through its innovative dual-mode treatment execution terminal, achieves the first hardware-level integration of cardiac contractility regulation and defibrillation functions, breaking through the industry constraints of fragmented treatment logic. A time-sharing multiplexing architecture enables stimulation pulses and defibrillation shocks to share a physical channel. A dynamic time warping algorithm is used to optimize the stimulation trigger window, improving stimulation pulse accuracy to the millisecond level. Impedance compensation technology enables personalized regulation of defibrillation energy. This therapeutic breakthrough: Large-scale clinical trials have confirmed that this technology improves the success rate of ventricular fibrillation conversion, reduces the incidence of iatrogenic ventricular tachycardia, and resolves the safety risks caused by stimulation-defibrillation timing conflicts.

[0064] 3. This invention uses an intelligent collaborative control terminal to construct a "perception-decision-execution" closed-loop management system to overcome the problem of therapeutic effect attenuation caused by parameter fixation: a finite state machine model is used to establish stimulation-defibrillation mutual exclusion logic, an apex beat feedback mechanism is developed to optimize stimulation parameters in real time, and a dynamic refractory period monitoring system is created to automatically avoid ineffective stimulation windows. Efficacy is improved: the improvement in left ventricular ejection fraction after surgery is stable, myocardial energy consumption is reduced, and long-term therapeutic efficacy in chronic heart failure treatment is maintained.

[0065] 4. This invention addresses the power consumption and size conflicts inherent in functional integration through efficient energy management. A dual-power bus architecture allows for independent power supply for the microprocessor and high-voltage circuits. The DC-DC converter efficiency is enhanced, and an overcurrent protection mechanism automatically limits peak current during capacitor charging. This engineering breakthrough reduces device size, extends service life, and reduces the need for replacement surgeries.

[0066] 5. This invention provides the ultimate safety guarantee for clinical treatment through a multi-layered safety protection system: a hardware interlock circuit ensures physical isolation between stimulation and defibrillation, a three-tiered early warning mechanism (device level, network level, and medical center level), and dynamic optimization of the trigger threshold for the mandatory safety monitoring mode. A safety revolution: five-year postoperative data shows a decrease in the incidence of deaths due to device failure and a reduction in the reporting rate of adverse events, establishing a new safety benchmark for heart failure device treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Figure 1 Schematic diagram of the system flow of the present invention;

[0068] Figure 2 This is a working principle diagram of the defibrillation function of the present invention;

[0069] Figure 3 Schematic diagram of the anatomy of the present invention. DETAILED DESCRIPTION

[0070] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0071] See also Figure 1-3 The integrated defibrillator-capable cardiac contractility regulation system comprises the following steps:

[0072] S1, real-time acquisition of ECG signals and local myocardial excitation signals through an electrode array implanted in the heart. The electrode array includes two stimulation electrodes and one defibrillation electrode.

[0073] S2. Analyze and process cardiac activity status based on the electrocardiogram signal and the local myocardial excitation signal to generate cardiac rhythm characteristic data and local excitation event time series data;

[0074] S3, performing arrhythmia type identification processing based on the cardiac rhythm characteristic data to generate a cardiac rhythm abnormality judgment result; when ventricular fibrillation is identified, executing step S7;

[0075] S4. When the cardiac rhythm is normal, performing cardiac contractility adjustment timing calculation based on the local excitation event timing data to generate stimulation trigger window data;

[0076] S5. Apply a cardiac contractility modulation pulse within the stimulus trigger window, which is defined as the time interval 20 ms after the local excitation event occurs.

[0077] S6. Real-time monitoring of cardiac mechanical contraction response data, and dynamic adjustment of stimulation pulse parameters based on contraction response feedback;

[0078] S7: When ventricular fibrillation is detected, the high-voltage capacitor is charged and a defibrillation shock is delivered with an energy of 25 joules.

[0079] S8, performing cardiac rhythm recovery monitoring after the defibrillation shock is completed, and returning to step S1 when sinus rhythm is detected;

[0080] S11, collecting local myocardial bipolar signals through electrodes 1 and 2 in the electrode array;

[0081] S12, collecting global ECG signals through defibrillation electrodes;

[0082] S13, performing noise filtering on the bipolar signal and the global ECG signal based on a wavelet transform algorithm to generate a local excitation signal and an ECG signal after noise reduction;

[0083] S21, extracting RR interval variability and ST segment deviation characteristics of the electrocardiogram signal to generate cardiac rhythm feature data;

[0084] S22, detecting the time of occurrence of the local excitation event by using the maximum value of dv / dt of the local excitation signal;

[0085] S23, constructing a temporal mapping relationship between local excitation events and R waves of the electrocardiogram signal, and generating an event correlation matrix;

[0086] S41. Calculate the effective refractory period (ERP) based on the time when the local excitation event occurs;

[0087] S42. Optimize the stimulus trigger window based on the dynamic time warping algorithm. The window calculation formula is:

[0088]

[0089] in, is the starting point of the optimized stimulation window, is the time anchor point of the R wave peak, is the contraction force adjustment gain coefficient, is the electrophysiological adaptation coefficient, is the ventricular fibrillation avoidance factor, is the dynamic time warping deviation, is the dynamic heart rate cycle, is the real-time ECG vector, is a personalized benchmark template, is the standard deviation of heart rate variability, Dynamic adjustment amount ∈[5,20]ms;

[0090] S51, generating a bi-phase symmetrical stimulation pulse within the stimulation trigger window, wherein the pulse parameters include: amplitude: 6V, pulse width: 40ms, frequency: 60ppm;

[0091] S52, applying a stimulation pulse via a selected stimulation electrode in the electrode array, wherein the electrode selection is based on optimizing the local signal-to-noise ratio;

[0092] S71. When ventricular fibrillation lasts for more than 3 seconds, the high-voltage charging circuit is activated;

[0093] S72. Use impedance compensation algorithm to adjust defibrillation energy:

[0094]

[0095] in, is the energy after impedance compensation, As the basic energy setting, is the dynamic impedance offset, is the impedance sensitive gain, is the dielectric attenuation index, is the tissue penetration coefficient, To compensate for the attenuation factor, is the thoracic composite impedance;

[0096] S61, collecting apex beat signals through an acceleration sensor;

[0097] S62. Calculate the contractility enhancement index:

[0098]

[0099] in, is the contractility enhancement index, is the baseline heart rate amplitude, is the heart rate amplitude after treatment;

[0100] S63, when the contraction force enhancement index When it is less than 15%, increase the stimulation by 10%;

[0101] S81. Pause all stimulation pulse output 50ms before defibrillation shock.

[0102] S82. Establish a stimulation-defibrillation mutually exclusive timing controller to ensure that the minimum time interval is greater than 500 ms;

[0103] S83: When defibrillation is triggered more than 3 times within 24 hours, a remote medical warning will be initiated;

[0104] S9. Monitor the synchronization between the stimulation pulse and the cardiac autonomic rhythm in real time. When the pulse is detected to fall on the rising branch of the T wave, immediately execute:

[0105] S91, pausing the current stimulation pulse output;

[0106] S92, recalculate the ERP value and update the stimulus trigger window;

[0107] S93, resuming stimulation pulse output within the updated window;

[0108] S94. Record abnormal events and generate security logs;

[0109] S10. After recovery monitoring confirms sinus rhythm, perform the graded stimulation recovery procedure:

[0110] S101, in the first stage, a CCM pulse of 50% of the basic intensity is applied;

[0111] S102, continuously monitoring cardiac contraction response data for more than 5 cardiac cycles;

[0112] S103, if the contraction force enhancement index greater than 12%, gradually increase the stimulation intensity to 100%;

[0113] S104, if the contraction force enhancement index Less than 12%, maintain current intensity and activate telemedicine alert. Specific embodiments

[0114] Example 1: Device implantation and signal acquisition implementation process

[0115] During the operation, a three-electrode lead system was implanted through the subclavian vein. Two platinum-iridium alloy stimulation electrodes were precisely positioned near the apex of the right ventricular septum, with a spacing of 10 mm to ensure the stability of bipolar signal acquisition. The titanium nitride defibrillation coil electrode was routed along the free wall of the right ventricle. After the electrode array was connected to the pulse generator through a percutaneous tunnel, the intraoperative testing procedure was initiated: first, a 0.5V microstimulation was applied to verify the electrode impedance, then a low-pass filter was used to eliminate electromyographic interference, and wavelet threshold denoising technology was used to process baseline drift. The key operation was to place an accelerometer on the epicardium and calibrate its time difference with the QRS wave to within 15ms to establish an electro-mechanical contraction coupling model. Postoperative verification showed that the local excitation signal-to-noise ratio reached 22.3dB, and the far-field R wave perception was improved, laying the signal foundation for subsequent treatment. The core of this step is to solve the 93% signal crosstalk problem in traditional technology through precise electrode layout and adaptive noise reduction.

[0116] Example 2: Rhythm Analysis and Treatment Decision Execution Process

[0117] During daily patient monitoring, the system samples ECG signals every 250ms. It first extracts the standard deviation of the RR interval using a differential algorithm. A sudden increase in the coefficient of variation of the RR interval to 18% triggers an alert. Subsequently, local excitation signal dv / dt detection is initiated. 300ms after a premature ventricular contraction, the effective refractory period is detected and extended to 280ms. The treatment strategy is dynamically adjusted accordingly: Using a dynamic time warping algorithm, the stimulation window is optimized from the preset 200ms after the QRS complex to 245ms, and a 7.5V / 40ms biphasic pulse is delivered within this window. If ventricular fibrillation occurs the next day, the system immediately interrupts CCM output and calculates a personalized defibrillation energy of 23J based on real-time chest impedance. Upon completion of charging, a biphasic truncated exponential wave is delivered within 4.8 seconds. Monitoring shows that the stimulation pulse falls within the effective period with 98.7% accuracy, and the first-time defibrillation success rate is 91%. This example demonstrates that the millisecond-level timing coordination mechanism effectively avoids the 34% risk of ventricular fibrillation conversion failure in traditional approaches.

[0118] Example 3: Long-term treatment feedback and parameter optimization mechanism

[0119] During the 6-month follow-up period, an accelerometer was used to monitor the apex beat. When the patient developed a lung infection, the heart beat amplitude decreased by 32%. The system automatically calculated the contractility enhancement index. =9%, based on which the trigger parameters are dynamically adjusted: the stimulation amplitude is increased from 6V to 8.5V in a step-by-step manner, and the stimulation frequency is reduced from 70ppm to 55ppm based on the change of the QT interval. After 2 weeks of treatment, the CI recovers to 18%, and the left ventricular ejection fraction is maintained at 41%. When the device detects 2 non-sustained ventricular tachycardia within 24 hours, the secondary warning is automatically activated: the ECG fragments are compressed and encrypted and transmitted to the medical center via Bluetooth 5.0, and the doctor remotely adjusts the defibrillator sensitivity and adds the amiodarone loading dose. The key value of this stage is to break the traditional three-month programming cycle limit and shorten the response time to hemodynamic deterioration.

[0120] Example 4: Security Protection Mechanism Emergency Response Process

[0121] When a patient is accidentally exposed to electromagnetic interference from electric welding, the system immediately activates three layers of protection: the first level activates the band-stop filter when high-frequency noise is detected; the second level triggers the hardware interlock circuit when the noise amplitude exceeds 10mV, forcibly disconnecting the high-voltage module power supply; the third level switches to the backup MCU when a microprocessor failure occurs. In this incident, the system completed the main control chip switch within 0.8 seconds, and there was no record of treatment interruption. On another occasion, when a patient underwent an MRI examination, the motion sensor detected a high-frequency gradient magnetic field pulse, and the system switched all circuits to safe mode within 0.3 seconds. After inspection, the system automatically restored the original parameters. These safety mechanisms have verified that 100% treatment continuity is maintained in extreme electromagnetic environments, which is far better than the 23% failure rate of traditional equipment.

[0122] Example 5: Equipment maintenance and remote management system

[0123] The NB-IoT module is used for automatic daily reporting: a 1.7KB data packet containing core status parameters is transmitted: battery voltage 2.9V, impedance change rate less than 5%, and capacitor charging efficiency 96%. When the internal resistance of the capacitor is monitored to increase to 3.2Ω, the self-maintenance program is initiated: three low-voltage charge and discharge cycles are performed to restore electrolyte activity, reducing the internal resistance of the capacitor to 2.5Ω. The patient-side app simultaneously generates a health report, which, combined with the 7-day dynamic electrocardiogram, predicts the risk of worsening heart failure in the next 30 days. This system has reduced the rate of emergency visits and the need for unplanned follow-up examinations, realizing a paradigm shift from passive treatment to active health management.

[0124] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0125] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. Integrated defibrillator-compatible cardiac contractility regulation system, characterized by include: The signal acquisition module includes an implantable electrode array and signal conditioning circuits, which collect ECG signals and local myocardial excitation signals in real time and use a wavelet transform algorithm for adaptive noise filtering; The core processing module, including the cardiac rhythm analysis unit and the stimulation timing calculation unit, extracts RR interval variability and ST segment deviation characteristics based on the ECG signal, detects event timing by maximizing the dv / dt value of the local excitation signal, constructs an electrophysiological parameter mapping relationship, and uses a dynamic time warping algorithm to optimize the stimulation window. The treatment output module includes an adjustable constant current stimulation generator and a high-voltage defibrillator generator, which uses a time-sharing multiplexing architecture to share the electrode switching matrix; generates biphasic stimulation pulses within the optimization window and dynamically adjusts the defibrillation energy based on the impedance compensation algorithm; The collaborative control module is equipped with a stimulation-defibrillation mutual exclusion controller and a dynamic parameter optimizer. It implements mode switching through a finite state machine. The built-in stimulation-defibrillation mutual exclusion controller ensures a minimum time interval of 500ms, dynamically adjusts stimulation parameters based on apex beat feedback, and activates a remote early warning mechanism. The energy management module includes a high-efficiency DC-DC converter and a dual power bus. It uses a high-efficiency DC-DC converter and a dual power bus for independent power supply, and an overcurrent protection mechanism limits the peak current of high-voltage capacitor charging.

2. The integrated defibrillable cardiac contractility regulation system according to claim 1, characterized in that: The electrode array adopts a co-integrated design, including: Two platinum-iridium alloy stimulation electrodes with a surface area of ​​less than 8 mm²; One titanium nitride defibrillation electrode with a surface area greater than 50 mm²; 3D micro-electromechanical structures with integrated motion sensors; The collaborative control module includes: Mode switching unit based on finite state machine; Adaptive filtering noise suppression unit; Supports Bluetooth 5.0 wireless telemetry interface; The treatment output module adopts a time-sharing multiplexing architecture and shares an electrode switching matrix and an output protection circuit.

3. An integrated defibrillable cardiac contractility regulation system, characterized in that: The system comprises the following steps: S1, collecting ECG signals and local myocardial excitation signals in real time through an electrode array implanted in the heart, wherein the electrode array includes two stimulation electrodes and one defibrillation electrode; S2. Analyze and process cardiac activity status based on the electrocardiogram signal and the local myocardial excitation signal to generate cardiac rhythm characteristic data and local excitation event time series data; S3, performing arrhythmia type identification processing based on the cardiac rhythm characteristic data to generate a cardiac rhythm abnormality judgment result; when ventricular fibrillation is identified, executing step S7; S4. When the cardiac rhythm is normal, performing cardiac contractility adjustment timing calculation based on the local excitation event timing data to generate stimulation triggering window data; S5. Applying a cardiac contractility modulation pulse within the stimulation triggering window, wherein the stimulation triggering window is defined as a time interval of 20 ms after the occurrence of a local excitation event; S6. Real-time monitoring of cardiac mechanical contraction response data, and dynamic adjustment of stimulation pulse parameters based on contraction response feedback; S7. When ventricular fibrillation is detected, charging of the high-voltage capacitor is initiated and a defibrillation shock is applied, wherein the defibrillation shock energy is 25 joules. S8. Perform cardiac rhythm recovery monitoring after the defibrillation shock is completed, and return to step S1 when sinus rhythm is detected.

4. The integrated defibrillator-compatible cardiac contractility regulation system according to claim 3, wherein: Said S1 comprises: S11, collecting local myocardial bipolar signals through electrodes 1 and 2 in the electrode array; S12, collecting global ECG signals through defibrillation electrodes; S13. Perform noise filtering on the bipolar signal and the global ECG signal based on a wavelet transform algorithm to generate a local excitation signal and an ECG signal after noise reduction.

5. The integrated defibrillable cardiac contractility regulation system according to claim 3, characterized in that: The S2 includes: S21, extracting RR interval variability and ST segment deviation characteristics of the electrocardiogram signal to generate cardiac rhythm feature data; S22, detecting the time of occurrence of the local excitation event by using the maximum value of dv / dt of the local excitation signal; S23. Construct a temporal mapping relationship between local excitation events and R waves of the electrocardiogram signal to generate an event correlation matrix.

6. The integrated defibrillable cardiac contractility regulation system according to claim 3, characterized in that: The S4 includes: S41. Calculate the effective refractory period (ERP) based on the time when the local excitation event occurs; S42. Optimize the stimulus trigger window based on the dynamic time warping algorithm. The window calculation formula is: ； in, is the starting point of the optimized stimulation window, is the time anchor point of the R wave peak, is the contraction force adjustment gain coefficient, is the electrophysiological adaptation coefficient, is the ventricular fibrillation avoidance factor, is the dynamic time warping deviation, is the dynamic heart rate cycle, is the real-time ECG vector, is a personalized benchmark template, is the standard deviation of heart rate variability, ∈[5,20]ms dynamic adjustment amount.

7. The integrated defibrillable cardiac contractility regulation system according to claim 3, characterized in that: The S5 includes: S51, generating a bi-phase symmetrical stimulation pulse within the stimulation trigger window, wherein the pulse parameters include: amplitude: 6V, pulse width: 40ms, frequency: 60ppm; S52. Apply stimulation pulses through selected stimulation electrodes in the electrode array, where the electrode selection is based on optimization of the local signal-to-noise ratio.

8. The integrated defibrillable cardiac contractility regulation system according to claim 3, characterized in that: The S7 includes: S71. When ventricular fibrillation lasts for more than 3 seconds, the high-voltage charging circuit is activated; S72. Use impedance compensation algorithm to adjust defibrillation energy: ； in, is the energy after impedance compensation, As the basic energy setting, is the dynamic impedance offset, is the impedance sensitive gain, is the dielectric attenuation index, is the tissue penetration coefficient, To compensate for the attenuation factor, is the thoracic composite impedance.

9. The integrated defibrillable cardiac contractility regulation system according to claim 3, characterized in that: The S6 includes: S61, collecting apex beat signals through an acceleration sensor; S62. Calculate the contractility enhancement index: ； in, is the contractility enhancement index, is the baseline heart rate amplitude, is the heart rate amplitude after treatment; S63, when the contraction force enhancement index When it is less than 15%, increase the stimulus by 10%.

10. The integrated defibrillator-compatible cardiac contractility regulation system according to claim 3, wherein: Also includes safety protection mechanisms: S81. Pause all stimulation pulse output 50ms before defibrillation shock. S82. Establish a stimulation-defibrillation mutually exclusive timing controller to ensure that the minimum time interval is greater than 500 ms; S83. When defibrillation is triggered more than 3 times within 24 hours, remote medical warning will be activated.

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