A pulse ablation device and system

Abstract

This invention relates to the field of medical device technology and discloses a pulse ablation device and system, including: a main control system, a sub-control system, a high-voltage generation module, an external electrocardiogram signal input module, an electrode selection module, and an ablation electrode module. The impedance measurement module of the sub-control system applies an AC excitation signal to the selected electrode pair, extracts the resistive component using zero-crossing in-phase demodulation, and calculates the pure resistive contact impedance after removing parasitic capacitive reactance. The main control system calculates the variance of the R-R interval variation of the heartbeat, subtracts the discharge delay time to reconstruct the discharge window when the variance is greater than a set threshold, and outputs a pulse trigger signal when the contact impedance is within a set range and the window is open. This invention removes parasitic capacitive reactance interference, improves the accuracy of contact and damage assessment, and adaptively shrinks the discharge window by combining variance variation, ensuring that the pulse energy is released during the absolute refractory period of the myocardium, effectively avoiding the risk of inducing arrhythmias.

Description

Technical Field

[0001] This invention relates to a pulse ablation device and system, belonging to the field of medical device technology. Background Technology

[0002] Current high-frequency pulse ablation technology uses high-voltage pulses to induce irreversible electroporation in target tissues and has been applied to cardiac electrophysiology diagnosis and treatment and surgery. Existing pulse ablation systems typically include a main control system, a high-voltage generation module, a sub-control system, and a multi-channel ablation electrode catheter. Traditional solutions often use a one-to-one connection between the sub-control system and the ablation electrode. As the number of electrodes increases, the number of sub-control modules required also increases, which not only increases the size and cost of the equipment but also makes the wiring more complex. The airflow distribution formed by the cooling fan deteriorates, increasing the risk of heat accumulation on the circuit board. If a switch matrix is ​​used to repeatedly select multiple electrode channels, conflicts can easily occur during the cross-switching of multiple sub-control systems, leading to short circuit breakdown and potentially causing high-voltage signal crosstalk and abnormal energy release.

[0003] Besides the limitations of the aforementioned hardware topology and switch selection logic, existing systems also have shortcomings in the software control methods for discharge timing. For example, Chinese invention patent CN109820592B discloses an adaptive pulse ablation device based on electrocardiogram waveforms. This device determines the effective refractory period threshold by extracting the electrocardiogram signal before ablation and passively controls the pulse release duration within the current heartbeat cycle by directly relying on the length of the previous effective refractory period. However, this scheme is based on the assumption that the patient's cardiac cycle changes are gradual and linearly recursive. In actual high-voltage ablation, electrophysiological stimulation-induced heart rate fluctuations often manifest as sudden, discrete jumps between continuous heartbeat intervals. This control mechanism, which extrapolates the discharge window based on historical preceding states, carries the risk of phase control lag when arrhythmias occur, easily leading to high-voltage pulses mistakenly entering the vulnerable period of the ventricle. Furthermore, it also has limitations when parameters exceed limits. The method of reducing pulse energy may affect the critical field strength required for the formation of irreversible transmural electroporation in the target tissue. High-voltage pulse ablation needs to avoid the vulnerable period of the ventricle to reduce the risk of inducing arrhythmias such as ventricular fibrillation. Existing systems usually use a fixed discharge delay time based on the ECG trigger signal, which is difficult to adjust with changes in heart rate and the interval fluctuations between consecutive heartbeats. It is difficult to ensure that the pulse is always released within the absolute refractory period of myocardial electrophysiology. In addition, the contact state between the ablation electrode and the target tissue and the degree of tissue electroporation are usually judged by the impedance change before and after ablation. There are parasitic distributed capacitances in the multi-channel switching matrix, and there are also polarization capacitances at the interface between the electrode and the tissue. During low-voltage excitation measurement, reactive leakage current will be generated, causing phase shift between the acquired voltage and current signals, which will result in false drift of apparent impedance and make it difficult to accurately reflect the change in the true conductivity resistance of the tissue.

[0004] Therefore, the technical problem to be solved by this invention is how to avoid selection conflicts during the reuse of multi-channel high-voltage switches, adjust the discharge permission time window according to heart rate changes, and reduce the impact of reactive leakage current on impedance measurement in order to obtain impedance parameters that can reflect the true state of tissue damage. Summary of the Invention

[0005] To address the problems in the background art, the technical solution of the present invention is as follows: A pulse ablation system, comprising: The main control system is connected to the external ECG signal input module and the high voltage generation module. The sub-control system is connected to the electrode selection module, and the electrode selection module is electrically connected to the ablation electrode module. The sub-control system includes an impedance measurement module. The impedance measurement module is used to apply an AC excitation signal to the ablation electrode pair selected by the electrode selection module before ablation discharge. It uses the zero-crossing in-phase demodulation clock of the AC excitation signal to extract the resistive voltage component and resistive current component that are in phase with the AC excitation signal from the voltage and current signals collected from the ablation electrode pair. Based on the resistive voltage component and resistive current component, the pure resistive contact impedance after removing the parasitic capacitive reactance component of the line is calculated. The main control system is used to extract the ECG R wave peak based on the ECG signal obtained from the external ECG signal input module, collect the RR interval of a set number of consecutive heartbeats and calculate the variance of the RR interval. When the variance of the RR interval is greater than the set physiological jitter threshold, the current ECG R wave peak detected in real time is used as the reference timing start point. The calculated positive correlation window indentation is deducted from the preset basic discharge delay time, and the discharge time interval is advanced and narrowed to reconstruct the discharge permission time window to ensure that the pulse release avoids the vulnerable period of the ventricle. The main control system is used to drive the output of a pulse trigger signal to the high-voltage generation module when the impedance of the pure resistor is within the set contact range and the discharge allowable time window is open.

[0006] Preferably, the discharge delay time includes both atrial discharge delay time and ventricular discharge delay time; the main control system is used to generate a first discharge sequence falling into the absolute refractory period of the atrium by superimposing the atrial discharge delay time on the obtained ECG R wave peak time node in atrial ablation mode; the main control system is used to generate a second discharge sequence falling into the absolute refractory period of the ventricle by superimposing the ventricular discharge delay time after deducting the window indentation on the ECG R wave peak time node in ventricular ablation mode; the pulse trigger signal is output when the first discharge sequence or the second discharge sequence arrives.

[0007] Preferably, the sub-control system includes a sub-main control module and a gating interlock module connected to the sub-main control module via signal; the electrode selection module includes a high-voltage switching unit, and the sub-main control module is used to receive the channel gating command from the main control system and drive the high-voltage switching unit to conduct; when the gating interlock module detects that two or more sub-control systems send gating enable signals to the same ablation electrode in the ablation electrode module, the gating interlock module pulls the gating enable signal low to zero level and blocks the transmission circuit of the pulse trigger signal, while reporting a channel conflict fault signal to the main control system.

[0008] Preferably, the impedance measurement module is also used to apply an AC excitation signal to the ablation electrode pair again after the high-voltage generation module completes the ablation pulse release, and extract and calculate the post-ablation damage impedance; the main control system is used to calculate the ratio of the post-ablation damage impedance to the pure resistance contact impedance. When the ratio is between 0.70 and 0.80, it is determined that the ablated tissue has formed an effective irreversible electroporation injury; when the ratio is greater than 0.80, the main control system is used to issue an additional ablation prompt command and limit the cumulative number of ablation discharges at the same ablation position to no more than 4 times; the threshold value for determining irreversible electroporation injury can be preset according to the characteristics of the target ablated tissue; the main control system is also used to maintain the high-voltage lockout state and issue a poor contact alarm signal before ablation discharge when the pure resistance contact impedance is not in the set contact range, so as to prompt the adjustment of the contact position of the ablation catheter.

[0009] Preferably, the sub-control system includes a high-voltage pulse generation module and a half-bridge isolated power supply module. The high-voltage pulse generation module includes a half-bridge drive unit and a power switch unit. The half-bridge isolated power supply module is used to convert the input power supply into a 15V positive bias drive voltage and a -4V negative bias turn-off voltage for use by the half-bridge drive unit. The half-bridge drive unit is used to convert the low-voltage control level of the sub-control system into a high-voltage drive level, driving the power switch unit to turn on or off, so as to output a high-voltage pulse waveform to the ablation electrode module.

[0010] Preferably, an opto-isolation module is provided between the sub-control system and the main control system. The opto-isolation module is used to electrically isolate the high-voltage control commands issued by the main control system and the impedance data uploaded by the sub-control system, so as to prevent mutual interference between the sub-control system and the main control system during the high-voltage ablation process, and to cut off the transmission path of the common-mode interference generated by the high-voltage generating module during the pulse discharge process to the main control system.

[0011] Preferably, the main control system includes a high-voltage power supply measurement module and a discharge protection module. The high-voltage power supply measurement module is used to collect the output voltage and output current of the high-voltage generating module in real time. When the deviation between the collected output voltage and the set ablation voltage exceeds the set voltage error range, or when the collected output current exceeds the set overcurrent threshold, the main control system is used to cut off the high-voltage enable signal and control the discharge protection module to connect the energy discharge circuit of the high-voltage energy storage unit.

[0012] Preferably, the external ECG signal input module is used to connect to the ECG acquisition module, and the main control system is used to perform threshold cross-filtering on the received ECG signal to locate the peak of the R wave, continuously extract the RR interval time series of a set number of adjacent heartbeats, and calculate the variance of the RR interval time series as the variance. When the variance is greater than the set physiological jitter threshold, the main control system is used to determine the number of milliseconds of indentation according to the positive proportional mapping relationship between the variance and the window indentation amount, and deduct the number of milliseconds of indentation from the preset discharge delay time to reconstruct the discharge permission time window, taking the located ECG R wave peak as the timing start point.

[0013] Preferably, the pulse ablation system further includes a display module and a foot pedal control module. The display module is communicatively connected to the main control system and is used to display the ablation electrode selection topology, ablation parameters, and contact impedance alarm status. The foot pedal control module is signal-connected to the main control system and includes a high-voltage charging control unit, an ablation trigger control unit, and a forced exit control unit. When the main control system receives a trigger signal from the forced exit control unit, it blocks the high-voltage pulse output and resets the electrode selection module.

[0014] A pulse ablation device for operating a pulse ablation system.

[0015] Compared with the prior art, the beneficial effects of the present invention are: 1. In the pulse ablation system, by reusing multiple channels and cooperating with gating interlocks, the number of hardware required for one-to-one configuration of sub-control systems and ablation electrodes can be reduced, simplifying the internal wiring connections of the equipment and reducing the space occupied by the equipment. At the same time, it can reduce the risk of short circuits and high-voltage signal crosstalk during the cross-gating process of multiple high-voltage channels, and reduce the heat accumulation on the circuit board when the high voltage is continuously working, making the pulse ablation system operate more stably.

[0016] 2. Adjusting the discharge permissible time window based on the changes in the RR interval of continuous heartbeats allows the pulse release timing to vary with the patient's heart rate fluctuations, avoiding the problem that a fixed discharge delay time cannot adapt to changes in the heartbeat interval. This enables the ablation pulse to avoid the vulnerable period of the ventricle as much as possible, reducing the risk of arrhythmias such as ventricular fibrillation induced by high-voltage pulses and improving the electrophysiological safety of the cardiac ablation process.

[0017] 3. By extracting the resistive voltage and resistive current components that are in phase with the AC excitation signal through the impedance measurement module, the influence of the parasitic distributed capacitance of the switch array and the polarization capacitance of the electrode-tissue interface on the impedance measurement can be reduced, and false impedance drift caused by reactive leakage current can be avoided. The impedance obtained in this way can more accurately reflect the actual change of the conductivity resistance of myocardial tissue, and provide a more reliable basis for judging the contact status of the ablation electrode and the degree of irreversible electroporation damage to the tissue. Attached Figure Description

[0018] Figure 1 This is a diagram showing the hardware module topology and signal interaction of the pulse ablation system of the present invention; Figure 2 This is a discharge decision control diagram based on the contact impedance and heart rate variation of the present invention.

[0019] The objectives, features, and advantages of this invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0020] The technical solutions of the embodiments of this application will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of this application are within the scope of protection of this application.

[0021] A pulse ablation system, comprising: The main control system is connected to the external ECG signal input module and the high voltage generation module. The sub-control system is connected to the electrode selection module, and the electrode selection module is electrically connected to the ablation electrode module. The sub-control system includes an impedance measurement module. The impedance measurement module is used to apply an AC excitation signal to the ablation electrode pair selected by the electrode selection module before ablation discharge. It uses the zero-crossing in-phase demodulation clock of the AC excitation signal to extract the resistive voltage component and resistive current component that are in phase with the AC excitation signal from the voltage and current signals collected from the ablation electrode pair. Based on the resistive voltage component and resistive current component, the pure resistive contact impedance after removing the parasitic capacitive reactance component of the line is calculated. The main control system is used to extract the ECG R wave peak based on the ECG signal obtained from the external ECG signal input module, collect the RR interval of a set number of consecutive heartbeats and calculate the variance of the RR interval. When the variance of the RR interval is greater than the set physiological jitter threshold, the current ECG R wave peak detected in real time is used as the reference timing start point. The calculated positive correlation window indentation is deducted from the preset basic discharge delay time, and the discharge time interval is advanced and narrowed to reconstruct the discharge permission time window to ensure that the pulse release avoids the vulnerable period of the ventricle. The main control system is used to drive the output of a pulse trigger signal to the high-voltage generation module when the impedance of the pure resistor is within the set contact range and the discharge allowable time window is open.

[0022] Preferably, the discharge delay time includes both atrial discharge delay time and ventricular discharge delay time; the main control system is used to generate a first discharge sequence falling into the absolute refractory period of the atrium by superimposing the atrial discharge delay time on the obtained ECG R wave peak time node in atrial ablation mode; the main control system is used to generate a second discharge sequence falling into the absolute refractory period of the ventricle by superimposing the ventricular discharge delay time after deducting the window indentation on the ECG R wave peak time node in ventricular ablation mode; the pulse trigger signal is output when the first discharge sequence or the second discharge sequence arrives.

[0023] Preferably, the sub-control system includes a sub-main control module and a gating interlock module connected to the sub-main control module via signal; the electrode selection module includes a high-voltage switching unit, and the sub-main control module is used to receive the channel gating command from the main control system and drive the high-voltage switching unit to conduct; when the gating interlock module detects that two or more sub-control systems send gating enable signals to the same ablation electrode in the ablation electrode module, the gating interlock module pulls the gating enable signal low to zero level and blocks the transmission circuit of the pulse trigger signal, while reporting a channel conflict fault signal to the main control system.

[0024] Preferably, the impedance measurement module is also used to apply an AC excitation signal to the ablation electrode pair again after the high-voltage generation module completes the ablation pulse release, and extract and calculate the post-ablation damage impedance; the main control system is used to calculate the ratio of the post-ablation damage impedance to the pure resistance contact impedance. When the ratio is between 0.70 and 0.80, it is determined that the ablated tissue has formed an effective irreversible electroporation injury; when the ratio is greater than 0.80, the main control system is used to issue an additional ablation prompt command and limit the cumulative number of ablation discharges at the same ablation position to no more than 4 times; the threshold value for determining irreversible electroporation injury can be preset according to the characteristics of the target ablated tissue; the main control system is also used to maintain the high-voltage lockout state and issue a poor contact alarm signal before ablation discharge when the pure resistance contact impedance is not in the set contact range, so as to prompt the adjustment of the contact position of the ablation catheter.

[0025] Preferably, the sub-control system includes a high-voltage pulse generation module and a half-bridge isolated power supply module. The high-voltage pulse generation module includes a half-bridge drive unit and a power switch unit. The half-bridge isolated power supply module is used to convert the input power supply into a 15V positive bias drive voltage and a -4V negative bias turn-off voltage for use by the half-bridge drive unit. The half-bridge drive unit is used to convert the low-voltage control level of the sub-control system into a high-voltage drive level, driving the power switch unit to turn on or off, so as to output a high-voltage pulse waveform to the ablation electrode module.

[0026] Preferably, an opto-isolation module is provided between the sub-control system and the main control system. The opto-isolation module is used to electrically isolate the high-voltage control commands issued by the main control system and the impedance data uploaded by the sub-control system, so as to prevent mutual interference between the sub-control system and the main control system during the high-voltage ablation process, and to cut off the transmission path of the common-mode interference generated by the high-voltage generating module during the pulse discharge process to the main control system.

[0027] Preferably, the main control system includes a high-voltage power supply measurement module and a discharge protection module. The high-voltage power supply measurement module is used to collect the output voltage and output current of the high-voltage generating module in real time. When the deviation between the collected output voltage and the set ablation voltage exceeds the set voltage error range, or when the collected output current exceeds the set overcurrent threshold, the main control system is used to cut off the high-voltage enable signal and control the discharge protection module to connect the energy discharge circuit of the high-voltage energy storage unit.

[0028] Preferably, the external ECG signal input module is used to connect to the ECG acquisition module, and the main control system is used to perform threshold cross-filtering on the received ECG signal to locate the peak of the R wave, continuously extract the RR interval time series of a set number of adjacent heartbeats, and calculate the variance of the RR interval time series as the variance. When the variance is greater than the set physiological jitter threshold, the main control system is used to determine the number of milliseconds of indentation according to the positive proportional mapping relationship between the variance and the window indentation amount, and deduct the number of milliseconds of indentation from the preset discharge delay time to reconstruct the discharge permission time window, taking the located ECG R wave peak as the timing start point.

[0029] Preferably, the pulse ablation system further includes a display module and a foot pedal control module. The display module is communicatively connected to the main control system and is used to display the ablation electrode selection topology, ablation parameters, and contact impedance alarm status. The foot pedal control module is signal-connected to the main control system and includes a high-voltage charging control unit, an ablation trigger control unit, and a forced exit control unit. When the main control system receives a trigger signal from the forced exit control unit, it blocks the high-voltage pulse output and resets the electrode selection module.

[0030] A pulse ablation device for operating a pulse ablation system.

[0031] Example 1: The pulse ablation device in this example operates a high-frequency pulse ablation system applied to cardiac electrophysiological ablation. This system includes a main control system, a first sub-control system, a second sub-control system, a high-voltage generation module, a display screen, a foot pedal control module, an external ECG signal input module, and an ablation electrode array consisting of 12 ablation electrodes. The main control system includes an FPGA main control module, a pulse signal generation module, a subsystem selection module, and a temperature measurement module. Both the first and second sub-control systems include a microcontroller sub-main control module, an opto-isolation module, a high-voltage pulse generation module, an impedance measurement module, and an electrode selection module. The high-voltage switching unit in the electrode selection module uses a multi-channel high-voltage reed relay to form an electrode selection switch matrix. The high-voltage pulse generation module includes a half-bridge drive circuit and a power switch. The half-bridge isolated power supply module uses an isolated DC-DC power supply to provide a +15V positive gate drive voltage and a -4V negative bias turn-off voltage to the half-bridge drive circuit. The first and second sub-control systems are connected to the 12 ablation electrodes through the electrode selection switch matrix and construct a multi-channel reusable gating topology. When a gating control command is selected, both the first and second sub-control systems are simultaneously selected. When the same ablation electrode is used, the hardware logic trigger in the gating interlock module locks and pulls the gating enable signal low to zero, blocking the high-voltage pulse trigger circuit, reporting a channel conflict fault to the main control system, and displaying an electrode channel selection conflict alarm on the screen. This cuts off the high-voltage output circuit, eliminating multi-channel short circuits and high-voltage signal crosstalk caused by high-voltage switch matrix logic conflicts. In the actual hardware circuit layout, the gating interlock module is constructed using a dedicated hardware cross-interlock bus. The microcontroller sub-master modules of the first and second sub-control systems each bring out a hardware interlock enable pin, which is then connected to a common pull-up... On the low-level active interlock bus maintained by the resistor, the strobe enable output of each sub-control system is connected to a dual-input NAND gate circuit. Its input is connected to the control enable signal line of its own sub-control system and the status level signal line from the interlock bus, respectively. When two sub-control systems simultaneously issue a strobe high-level command for the same electrode, the bidirectional open-collector gate circuit on the bus is pulled low due to collision, causing the logic level of the interlock bus to suddenly drop to low level within 0.2μs. This forces the NAND gate output of each sub-control system to be clamped to low level, blocking the drive input pin of the half-bridge drive unit and realizing the hardware loop cutoff.

[0032] When the patient's heart rhythm fluctuates dynamically, the external ECG signal input module acquires the patient's ECG signal in real time. The FPGA main control module extracts the R-wave peak of the ECG through threshold cross-filtering and continuously extracts the RR intervals of five heartbeats, which are 800ms, 812ms, 788ms, 805ms, and 795ms, respectively. The average RR interval is calculated to be 800ms. The FPGA main control module accumulates the squared differences between the five RR intervals and the average, divides by 5, and obtains 67.6ms. 2 The variance value is used as the variation variance; the physiological jitter threshold corresponding to the 5ms standard deviation reference value is converted to 25ms. 2 67.6ms 2 If the fluctuation exceeds the set physiological jitter threshold, the main control system will respond to a variance of 67.6 ms. 2 The square root yields an overall standard deviation of 8.22 ms, which is corrected to 8.5 ms after overlaying sampling clock phase jitter compensation. This standard deviation characterizes the degree of discrete fluctuation in continuous cardiac intervals. Based on this, the main control system determines a 12 ms window indentation according to a preset proportional mapping relationship between the variance and the window indentation, i.e., the product of the indentation coefficient 1.41 and the corrected standard deviation of 8.5 ms. In atrial ablation mode, the FPGA main control module uses the obtained ECG R-wave peak time node as the timing start point, overlays a pre-set atrial discharge delay time, and generates a signal that absolutely does not fall into the atrium. The first discharge sequence during the refractory period outputs a pulse trigger signal when the first discharge sequence arrives. In ventricular ablation mode, the FPGA main control module determines the ventricular discharge delay time to be 250ms based on myocardial electrophysiological mapping logic. After deducting the 12ms window indentation, a corrected ventricular discharge delay time of 238ms is obtained. Based on this, a second discharge sequence falling within the absolute refractory period of the ventricle is generated, so that the subsequent pulse trigger time is locked in the ST segment or TP segment of the ECG waveform, ensuring that the high-frequency pulse train is released before the start of the ECG T wave, avoiding the risk of high-voltage pulses inducing arrhythmias by touching the vulnerable period of the ventricle.

[0033] Before pulse release, to eliminate interference from the parasitic distributed capacitance of the multi-channel reusable switch matrix and the polarization capacitance of the electrode-tissue interface on impedance measurement, the impedance measurement module applies a low-voltage sinusoidal excitation signal with a frequency of 20kHz to 100kHz and a peak-to-peak value of 5V to 12V to electrodes 1 and 2 selected by the first and second sub-control systems. The impedance measurement module uses the zero-crossing in-phase demodulation clock of the AC excitation signal to extract the purely resistive component in phase with the excitation voltage. When the forward excitation signal flows from the first sub-control system to the second sub-control system, the sampling terminal measures a forward in-phase voltage drop of 3.6V and a forward in-phase current sum of 0.048A, from which the forward purely resistive impedance is calculated. After the switch is inverted, the reverse excitation signal flows from the second sub-control system to the first sub-control system. The sampling terminal measures a reverse and non-reverse voltage drop of 3.6V and a reverse and non-reverse current sum of 0.048A. The reverse pure resistance impedance is calculated. The main control system calculates the arithmetic mean of the two values ​​to obtain the pure resistance impedance before ablation. Place the pure resistor against the impedance The electrodes 1 and 2 are compared with the preset first impedance threshold of 50Ω and the second impedance threshold of 200Ω to confirm good contact with the target myocardial tissue. The high voltage lockout is released and a good contact prompt is displayed on the screen. When the pure resistance contact impedance is detected to be less than 50Ω or greater than 200Ω and not within the preset contact range, the main control system maintains the high voltage pulse lockout state and pops up a poor contact alarm prompt on the screen to prompt the operator to adjust the contact position and pressure of the ablation catheter electrodes until the contact impedance falls into the preset range. In the excitation phase reversal control sequence, after the microcontroller completes the forward excitation sampling, it first outputs a 10μs silent shutdown command to disconnect the excitation bridge arm switch in the electrode selection switch matrix. Then, it changes the initial phase of the in-phase demodulation clock in the zero-crossing in-phase demodulation circuit by 180° and re-connects the diagonal excitation bridge arm switch. After the 5μs stable transition period after the excitation phase reversal is completed, the sampling circuit restarts the ADC synchronous sampling, thereby eliminating the back electromotive force impact and zero-crossing phase distortion generated at the moment of phase reversal switch switching.

[0034] The foot pedal control module includes a high-voltage charging control unit, an ablation trigger control unit, and a forced exit control unit. Upon receiving a trigger signal from the ablation trigger control unit, the main control system sets the output voltage of the high-voltage generation module to 1000V, and the high-voltage power supply measurement module provides real-time feedback that the output voltage is 1002V and within the preset error range. After detecting the arrival of the ECG R wave peak, the main control system delays for 238ms before entering the discharge permission time window corresponding to the second discharge sequence and outputs a pulse trigger signal. The half-bridge drive circuit of the first and second sub-control systems drives the power switch to conduct, applying configurable parameters to electrodes 1 and 2. The system uses a high-frequency pulse waveform with adjustable pulse width (1μs to 10μs), adjustable pulse frequency (100kHz to 200kHz), 20 pulses per group, and 5 repeated groups. The interval between groups can be set to an adjustable time or synchronized with the heartbeat RR interval. After the pulse is released, the system enters the low-voltage excitation and measurement circuit charging preparation stage. After the measurement circuit is stabilized by low-voltage charging (approximately 8 seconds), the impedance measurement module applies a low-voltage sinusoidal or low-voltage pulse AC excitation signal to electrodes 1 and 2 again and extracts the in-phase pure resistance component to measure the post-ablation damage impedance. The main control system calculates the ratio of the post-ablation damage impedance to the pure resistive contact impedance. The target impedance ratio is determined to be 76%, meaning it falls within the preset target range of 70% to 80%. This confirms the formation of effective irreversible electroporation damage in the target tissue and indicates ablation completion on the display screen. When the forced exit control unit is triggered, the main control system blocks the high-voltage pulse output and resets the electrode selection module. The aforementioned target impedance ratio range of 70% to 80% is determined based on the equivalent circuit model of irreversible electroporation of the myocardial cell membrane and data from in vitro electrophysiological experiments. Under the action of the electrical pulse, perforation of the phospholipid bilayer of the myocardial cell membrane leads to a sharp drop in membrane resistance. When the impedance ratio drops to 80%, it indicates that the cell membrane perforation density has reached the critical irreversible threshold. The inverse threshold is set; if the ratio is higher than 80%, the cell membrane is in a state of reversible perforation or incomplete perforation, requiring additional ablation; if the ratio is lower than 70%, it indicates that local thermal coagulation necrosis or vaporization has occurred in the tissue, resulting in a nonlinear change in dielectric resistance; the damage impedance ratio range of 0.70 to 0.80 is used as the preferred judgment criterion in the embodiment, and in specific engineering applications, it supports adaptive configuration and threshold calibration according to different ablation catheter electrode structure parameters, targeted myocardial anatomical locations, and tissue thickness characteristics; setting the cumulative discharge at the same location to no more than 4 times can prevent the accumulation of frequent pulse energy from causing the myocardial tissue temperature to exceed 50°C and resulting in thermal damage.

[0035] By combining time-division reusability of multi-subsystem switching matrices with hardware interlocking logic, an adaptive shrinking mechanism for discharge windows based on the variance of the RR interval of heartbeats, and bidirectional low-voltage excitation and orthogonal demodulation pure resistance extraction technology, the system reduces the number of subsystem modules and the risk of heat accumulation on the circuit board. At the same time, it eliminates high-voltage logic conflicts caused by cross-reuse of channels, avoids the risk of accidentally touching the vulnerable period of the ventricle under heart rate fluctuations, eliminates the interference of reactive leakage current generated by parasitic capacitance and interface polarization capacitance, ensures that ablation energy is released during the absolute refractory period of the myocardium, and provides impedance diagnostic parameters for objectively characterizing the state of tissue electroporation damage.

[0036] Example 2: The current isolated myocardial tissue pulse ablation experiment uses a constant temperature 37℃ saline bath, a 12-pole ablation catheter, a multi-lead ECG simulator, a single-channel 100MHz (or dual-channel 200MHz) bandwidth high-voltage differential probe, a DC to 120MHz frequency response current probe, and a digital oscilloscope with a bandwidth of 500MHz and a sampling rate of 1GS / s. The multi-lead ECG simulator injects a simulated ECG signal containing 50Hz power frequency harmonic interference and Gaussian white noise with a signal-to-noise ratio of 20dB into the external ECG signal input module of the main control system to simulate physiological electrical interference during the ablation process. During the selection of the low-voltage excitation frequency of the impedance measurement module, the reactive capacitive reactance generated by the polarization capacitance at the electrode-tissue interface and the sampling... The circuit phase lags; when the excitation frequency is 20kHz to 100kHz, the interface polarization capacitive reactance is less than 5Ω, and the phase error of the phase-locked demodulation is less than 0.5%. Therefore, a sinusoidal AC signal with a frequency of 20kHz to 100kHz and a peak-to-peak value of 5V to 12V is used as the low-voltage excitation signal. For the discharge permit time window, the main control system calculates the variance of the RR interval time series of 5 consecutive heartbeats and uses it as the variance variation. When the variance variation is greater than the set physiological jitter threshold, the number of milliseconds of indentation is determined according to the direct proportional mapping relationship between the variance value and the window indentation. The timing starts with the currently detected ECG R wave peak and is deducted from the preset basic discharge delay time to reconstruct the discharge permit time window. The test bench simultaneously records the standard deviation of the RR interval. To observe the fluctuations in continuous heartbeat intervals, the remaining calibration relationship is as follows: Where K is a dimensionless indentation coefficient, ranging from 1.0 to 2.0, with a preferred value of approximately 1.41 (the value is determined based on the square root calibration of the two-tailed coefficient of the 95% confidence interval of the normal distribution of continuous heartbeat intervals). This relationship is used to verify the calibration results of the window indentation. The discharge control still uses the variance and its corresponding direct proportional mapping relationship to determine the window indentation. In the experiment, 5ms was used as the physiological jitter reference value for the standard deviation of the RR interval, and the end point of the discharge permission time window was limited to at least 20 seconds before the T wave onset. The 5ms reference value is determined based on the engineering statistical distribution experience of continuous heartbeat intervals under normal sinus rhythm. When the standard deviation is less than 5ms, the heart rhythm is considered stable. The indentation coefficient of 1.41 is taken from the square root approximation of the two-tailed coefficient of the 95% confidence interval of the normal distribution, that is, the approximation of the square root of 2, 1.41. Under this calibration relationship, the indented discharge time window has a probability of more than 99% not crossing into the vulnerable period of the ventricle. When the indentation coefficient is less than 1, the coverage of sudden deviations in heart rhythm is insufficient; when it is greater than 2, the discharge permit time window is too narrow, and the pulse train cannot be released completely.

[0037] The experiment included the present invention sample group, control group one, control group two, and control group three. An out-of-range lower limit group and an out-of-range upper limit group were also set up for boundary testing of ablation parameters. The present invention sample group employed zero-crossing in-phase demodulation impedance measurement, discharge permissible time window indentation based on the variance of the RR interval variation, and dual hardware and software gating interlocks. Control group one retained bidirectional excitation but calculated impedance based on apparent peak sampling. Control group two used a fixed 250ms R-wave discharge delay. Control group three removed the hardware logic trigger interlocks within the microcontroller of the sub-control system and only used software polling to verify the gating instruction.

[0038] In the multi-channel reuse switching test, the main control system simultaneously sends gating commands for electrode 1 to the first sub-control system and the second sub-control system. The gating interlock module of the present invention triggers the hardware logic lock within 0.3μs after the command is issued, pulls the gating enable level down to 0V, blocks the high voltage output circuit, and the high voltage generation module maintains zero energy release. The control group three only performs software polling, and the lockout response time is 42.5μs. During this delay, the high voltage switch array cross-conducts, and the oscilloscope captures a transient short-circuit current impact with an amplitude of 850V. The gating conflict lockout response time of the control group one, control group two, the out-of-range lower limit group and the out-of-range upper limit group, which use the same hardware interlock settings, is 0.3μs.

[0039] In the interference suppression and impedance measurement test, after applying an excitation signal to the electrode pair of the control group, the forward apparent voltage difference was measured to be 4.12V and the apparent current sum was 0.0468A. The parasitic distributed capacitance of the line and the interface polarization capacitance caused a 21.5° phase shift between the voltage and current, from which the undecoupled apparent impedance was calculated to be 88.03Ω. The sample group of this invention uses the zero-crossing in-phase demodulation clock of the AC excitation signal to extract the resistive voltage component and the resistive current component. The forward in-phase voltage drop was measured during forward excitation. Forward in-phase current and The forward pure resistance impedance was calculated. After the switch is reversed, the reverse in-phase voltage drop is measured. Reverse in-phase current and The reverse pure resistance impedance was calculated. The main control system takes the arithmetic mean of the two to obtain the pure resistive contact impedance. In the sample group, control group 2, control group 3, lower limit group and upper limit group of the present invention, the phase offset angle is 0.0° and the undecoupled apparent impedance is 75.00Ω. The pure resistance impedance calculated by the in-phase resistive component of each group is 75.00Ω. Therefore, the apparent impedance of 88.03Ω obtained under the condition of 21.5° phase offset is directly compared with the pure resistance impedance of 75.00Ω. The 3.61V resistive voltage drop and 0.0481A resistive current extracted by zero-crossing in-phase demodulation correspond to the conductive resistance value of 75.00Ω.

[0040] In the dynamic cardiac rhythm fluctuation discharge safety test, the multi-lead ECG simulator sequentially output the RR intervals of five heartbeats: 792ms, 815ms, 785ms, 808ms, and 800ms. The main control system obtained an average RR interval of 800ms from this and calculated the variance of this time series. The test bench synchronously obtained a standard deviation of 11.8ms for the RR interval. This value exceeded the physiological jitter reference value of 5ms. After the variance exceeded the set physiological jitter threshold, the main control system determined a window indentation of 16.6ms based on the direct proportional mapping relationship between the variance value and the window indentation, and subtracted it from the baseline ventricular discharge delay time of 250ms, resulting in a corrected discharge delay time of 233.4ms. During calibration and verification, the corresponding window indentation result was also 16.6ms. The oscilloscope monitored the pulse release process of the sample group of this invention. The distance between the end of the ablation pulse train and the T wave start point was 32.5ms. The discharge end point of the control group 1, control group 3, the lower limit of the range group and the upper limit of the range group, which used the same dynamic indentation settings, was also 32.5ms from the T wave start point. The control group 2 used a fixed 250ms delay. The discharge end point was -14.2ms from the T wave start point. The tail pulse entered the rising segment of the T wave and generated a simulated ventricular fibrillation electrical signal.

[0041] In the ablation depth assessment and parameter window boundary test, the main control system was set to an ablation voltage of 1000V, and the pure resistance of the target myocardial tissue was set to 75.00Ω. For the group exceeding the lower limit of the range, the number of ablation pulse groups was set to 2. The post-ablation damage impedance was... Calculations yielded That is, 88.2%, which is higher than the upper limit of 80.0%. The tissue section showed that the irreversible electroporation lesion depth was 0.8 mm, which did not meet the transmural standard. The sample group of this invention used 5 sets of ablation pulses and measured... The resistance is 57.15Ω. That is, 76.2%, which is within the set range of 70.0% to 80.0%, and the tissue section showed a continuous transmural lesion depth of 3.2 mm; Control groups 1, 2, and 3 all used 5 sets of ablation pulses, and their post-ablation impedance ratios were all 0.762, and the transmural lesion depth was all 3.2 mm. For the group exceeding the upper limit of the range, the number of ablation pulse sets was increased to 8 sets, and the measured... The resistance is 46.50Ω. The percentage was 62.0%, which is lower than the lower limit of 70.0%. The tissue section showed that the transmural depth of the injury was 4.8 mm, accompanied by thermal blister damage, and the impedance measurement curve showed nonlinear fluctuations.

[0042] In the repeated ablation control test at the same location, ablation was performed sequentially at the non-compliant location with an initial impedance ratio of 88.2%. After the second ablation, the ratio dropped to 82.1%, still higher than the 80% upper limit for judgment. After the third ablation, the ratio dropped to 75.4%, entering the set range, and the main control system released the ablation lock. At another test point, after four consecutive ablations, the impedance ratio was still 81.5%. The main control system locked the high-voltage output circuit and displayed an over-discharge warning signal on the display screen to prevent the fifth discharge. In this group of tests, the gate interlock response, zero-crossing in-phase demodulation impedance measurement, discharge permission time window indentation based on variance, and the judgment of the impedance ratio after ablation correspond to channel conflict, reactive component interference, heartbeat interval fluctuation, and repeated ablation control process, respectively.

[0043] Example 3: This example uses four sub-control systems to expand the multi-channel topology of the high-frequency pulse ablation system. The system includes a main control system, a first sub-control system, a second sub-control system, a third sub-control system, a fourth sub-control system, a high-voltage generation module, a display screen, a foot pedal control module, and an ablation electrode array consisting of 16 ablation electrodes. The first and second sub-control systems form the first ablation pair, and the third and fourth sub-control systems form the second ablation pair. The ablation signal output ports of each sub-control system are connected to the 16 ablation electrodes respectively through the high-voltage switching unit in the electrode selection module. The high-voltage switching unit uses a multi-channel high-voltage reed relay to form an electrode selection switch matrix. In the multi-channel time-division reusable ablation process, the FPGA main control module controls the first ablation pair to release high-frequency pulse waveforms to selected electrodes 1 and 2. After a 150ms interval between the inter-subsystem groups of alternating discharge, the second ablation pair is then controlled to release high-frequency pulse waveforms to selected electrodes 3 and 4. This time-domain alternating discharge disperses the energy consumption of the power switching transistors and circuit boards, adjusts the physical flow field and heat distribution of the internal cooling fan, and reduces heat accumulation during continuous high-frequency and high-voltage operation. When a channel control anomaly causes the first and third sub-control systems to simultaneously select electrode 5, the hardware cross-interlock trigger in the selection interlock module latches the logic enable signal within 0.2μs. The voltage is pulled down to 0V zero level, blocking the transmission circuit of the pulse trigger signal and reporting a channel conflict fault signal to the main control system. The high-voltage power supply measurement module collects the output current of the high-voltage generator module in real time. When the output current exceeds the set overcurrent threshold, the main control system cuts off the high-voltage enable signal and simultaneously controls the power discharge MOSFET in the discharge protection module to turn on, so that the residual charge in the high-voltage energy storage capacitor is discharged through the 100Ω discharge resistor within 10μs. A channel selection conflict alarm pops up on the display screen. The high-voltage drive domain of each sub-control system and the low-voltage logic domain of the main control system are electrically isolated by opto-isolation modules to prevent mutual interference between high and low voltage domains during high-voltage pulse discharge. The high-voltage drive domains of each sub-control system are connected by high-speed differential optocoupler isolation chips with a withstand voltage of several kilovolts to transmit hardware cross-interlock signals. When a conflict occurs, the interlock signal is electrically isolated and transmitted at high speed across domains through differential optocouplers. Within 0.2μs, the selection enable signal between multiple subsystems is pulled down in time, and the discharge protection circuit is executed according to the above conditions.

[0044] Parasitic distributed capacitance of switch matrix To mitigate interference from reactive leakage current generated by polarization capacitance at the electrode-tissue interface, the impedance measurement module applies a low-voltage sinusoidal excitation signal with a frequency of 20kHz to 100kHz and a peak-to-peak value of 5V to 12V to the selected ablation electrode pair before ablation discharge; the zero-crossing point of the low-voltage sinusoidal excitation signal is used to generate a sampling synchronization clock. The quadrature phase-locked demodulation circuit processes the acquired raw voltage signal. and the original current signal Sampling is performed at a sampling rate of 10 MS / s. The resistive voltage and resistive current components are extracted by multiplying by a sinusoidal and cosine sequence of the same frequency and phase, followed by low-pass filtering with a cutoff frequency of 1 kHz. During forward excitation, the forward in-phase voltage drop component is extracted by the first and second sub-control systems. In-phase current component The forward pure resistance impedance was calculated. After the excitation signal is inverted, the reverse in-phase voltage drop component is extracted. With the reverse in-phase current component The reverse pure resistance impedance was calculated. The main control system calculates the arithmetic mean of the two values ​​to obtain the pure resistive contact impedance. When the pure resistance impedance R is between the first impedance threshold of 50Ω and the second impedance threshold of 200Ω, it is determined that the ablation electrode is in good contact with the target myocardial tissue, and the high voltage lockout is released.

[0045] Under conditions of severe heart rhythm fluctuations or ECG signal interference, the external ECG signal input module acquires the patient's ECG signal in real time. The FPGA main control module extracts the RR interval time series of five consecutive heartbeats, calculates the variance of this time series and uses it as the variance of variation; simultaneously, the standard deviation of the RR interval variance is obtained from the same set of RR intervals. The system converts the 5ms physiological jitter reference value into a set physiological jitter threshold with the same dimensions as the variance. When the variance exceeds the set physiological jitter threshold, the main control system determines the indentation milliseconds based on the direct proportional mapping relationship between the variance and the window indentation. This embodiment retains... The calibration relationship, in which This is used to verify the time scale of the window indentation. The main control system adjusts the window indentation from the baseline ventricular absolute refractory period discharge delay time. Subtracting from the value, a corrected discharge delay time is generated; if a sudden cardiac arrhythmia causes the corrected discharge permissible time window to be less than the duration of a single pulse, the time is adjusted accordingly. The FPGA main control module blocks the pulse trigger enable signal of the current heartbeat, pauses the discharge, and waits for the next heartbeat to stabilize. After the ablation pulse is released, the circuit is recharged through the low-voltage measurement circuit (charging time is about 8 seconds). Then, the impedance measurement module measures the impedance of the ablation damage again. The main control system calculates the ratio of the post-ablation damage impedance to the pure resistance contact impedance. When the ratio is greater than the preset upper limit of 80%, the system will increase the number of pulse groups from 5 to 6 and perform additional ablation. When the same ablation location is ablated 4 times consecutively and the ratio is still greater than 80%, the main control system will lock the high voltage pulse generation module, report an over-time warning signal, and stop discharging.

[0046] Example 4: This example combines Figures 1 to 2 This document describes a pulse ablation device and system, such as... Figure 1As shown, the external ECG signal input module connects to the ECG acquisition module to acquire ECG signals and transmits them to the main control system. The main control system extracts the ECG R-wave peak from the ECG signal acquired from the external ECG signal input module, collects the RR interval of a set number of consecutive heartbeats, and calculates the variance of the RR interval. When the variance exceeds a set physiological jitter threshold, the current ECG R-wave peak detected in real time is used as the baseline timing starting point. The calculated positive correlation window indentation is subtracted from the preset baseline discharge delay time, advancing and narrowing the discharge time interval to reconstruct the discharge permit time window, ensuring that pulse release avoids the vulnerable period of the ventricle. The impedance measurement module of the sub-control system, before ablation discharge, selects the electrode selection module for the ablation... An AC excitation signal is applied to the ablation electrode pair and the signal is acquired. The zero-crossing in-phase demodulation clock of the AC excitation signal is used to extract the resistive voltage component and resistive current component that are in phase with the AC excitation signal from the voltage and current signals acquired from the ablation electrode pair. The pure resistive contact impedance after removing the parasitic capacitive reactance component of the line is calculated based on the resistive voltage component and resistive current component. The pure resistive contact impedance is input to the main control system. When the pure resistive contact impedance is in the set contact range and the discharge permission time window is open, the main control system drives the output of a pulse trigger signal to the high voltage generation module. The high voltage generation module receives the pulse trigger signal and outputs a high voltage signal to the electrode selection module, which is then transmitted to the ablation electrode module through the electrode selection module.

[0047] like Figure 2 As shown, an ECG signal is acquired from an external ECG signal input module, the R-wave peak is extracted, and the variance of continuous heartbeat variation is calculated. The window indentation is then subtracted to reconstruct the discharge permissible time window. Simultaneously, an AC excitation signal is applied to the selected ablation electrode pair, and the in-phase resistive voltage and resistive current components are extracted. The pure resistive contact impedance, after removing the parasitic capacitive reactance component, is calculated. If the pure resistive contact impedance is determined to be outside the set contact range, the high-voltage pulse is locked, and a contact failure alarm is issued to prompt adjustment of the ablation catheter contact position. If the pure resistive contact impedance is outside the set contact range, the high-voltage pulse is locked, and a contact failure alarm is issued to prompt adjustment of the ablation catheter contact position. If the contact impedance is within the set contact range and the discharge allowable time window is open, a pulse trigger signal is driven to the high-voltage generation module to output a high-voltage pulse waveform to the ablation electrode module. After the pulse waveform is released and charged through the low-voltage measurement circuit, the ablation damage impedance is extracted and calculated, and the ratio of the ablation damage impedance to the pure resistance contact impedance is calculated. If the ratio is between 0.70 and 0.80, it is determined that the ablated tissue has formed an effective irreversible electroporation damage. If the ratio is not between 0.70 and 0.80, an additional ablation prompt command is issued.

[0048] Example 5: Different ablation catheters have different tube lengths and transmission wire distributions, which can cause changes in the parasitic capacitance of the line and lead to impedance measurement deviations. After the ablation system is connected to the ablation catheter, the impedance measurement module drives the excitation circuit to output a low-voltage sinusoidal excitation signal with a frequency of 10kHz to 200kHz and a peak-to-peak value of 5V to 12V to the ablation catheter electrode array placed in a sterile saline bath with a constant temperature of 37℃ and a conductivity of 1.5S / m. The quadrature phase-locked demodulation circuit collects the in-phase voltage drop component and the out-of-phase reactive component at different frequencies, locates the minimum point of reactive current based on the phase frequency response characteristics, and determines 100kHz or 20kHz as the low-voltage excitation frequency. At the same time, the ablation catheter electrode array is placed in an open-circuit floating state, and the impedance measurement module collects the parasitic capacitive reactance distribution data of the transmission line to measure the parasitic capacitance of the transmission line. It is written into the memory of the microcontroller sub-master module as a zero-point drift compensation reference, and the corresponding line parasitic capacitive reactance component is deducted in real time during the quadrature phase-locked demodulation calculation in the ablation process.

[0049] During the parasitic capacitive reactance subtraction process, the quadrature phase-locked demodulation circuit acquires the real and imaginary parts of the complex impedance data. The digital signal processor then calculates the data based on the 100kHz excitation frequency and the pre-stored parasitic capacitance of the transmission line. Calculate the baseline reactive power capacity component; after entering the admittance domain, subtract the baseline reactive power capacity component from the imaginary part of the actual measured complex admittance, and then take the reciprocal of the complex admittance after completing the digital zero-point drift subtraction to obtain the corrected pure resistance contact impedance, so as to reduce the impedance offset caused by the difference in distributed capacitance of transmission cables in different ablation conduits.

[0050] During the pre-verification process of high-voltage pulse release, the main control system receives the charging command issued by the foot pedal control module. The high-voltage power supply measurement module continuously samples the voltage and leakage current of the energy storage capacitor inside the high-voltage generation module for 100ms to confirm that the deviation between the actual voltage and the set voltage is within the preset allowable error range. The external ECG signal input module synchronously collects ECG signals, and the FPGA main control module verifies the ECG R wave peaks of 20 consecutive heartbeats. When a steep change in the slope of the ECG signal waveform or a baseline drift exceeding 0.5mV is detected, filtering is initiated, and the variance of the sliding RR interval time series is recalculated. This variance is used as the variation variance. When the pure resistance contact impedance is within the preset contact range of 50Ω to 200Ω and the high-voltage energy storage capacitor has been charged, the main control system releases the high-voltage lockout and maintains the pulse output ready state.

[0051] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the present invention.

[0052] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. A pulse ablation system, characterized in that, include: The main control system is connected to the external ECG signal input module and the high voltage generation module. The sub-control system is connected to the electrode selection module, and the electrode selection module is electrically connected to the ablation electrode module. The sub-control system includes an impedance measurement module. The impedance measurement module is used to apply an AC excitation signal to the ablation electrode pair selected by the electrode selection module before ablation discharge. It uses the zero-crossing in-phase demodulation clock of the AC excitation signal to extract the resistive voltage component and resistive current component that are in phase with the AC excitation signal from the voltage and current signals collected from the ablation electrode pair. Based on the resistive voltage component and resistive current component, the pure resistive contact impedance after removing the parasitic capacitive reactance component of the line is calculated. The main control system is used to extract the ECG R wave peak based on the ECG signal obtained from the external ECG signal input module, collect the RR interval of a set number of consecutive heartbeats and calculate the variance of the RR interval. When the variance of the RR interval is greater than the set physiological jitter threshold, the current ECG R wave peak detected in real time is used as the reference timing start point. The calculated positive correlation window indentation is deducted from the preset basic discharge delay time, and the discharge time interval is advanced and narrowed to reconstruct the discharge permission time window to ensure that the pulse release avoids the vulnerable period of the ventricle. The main control system is used to drive the output of a pulse trigger signal to the high-voltage generation module when the impedance of the pure resistor is within the set contact range and the discharge allowable time window is open.

2. The pulse ablation system according to claim 1, characterized in that, The discharge delay time includes the atrial discharge delay time and the ventricular discharge delay time. In atrial ablation mode, the main control system is used to generate a first discharge sequence that falls within the absolute refractory period of the atrium by superimposing the atrial discharge delay time on the obtained ECG R wave peak time node. In ventricular ablation mode, the main control system is used to generate a second discharge sequence that falls within the absolute refractory period of the ventricle by superimposing the ventricular discharge delay time after deducting the window indentation on the ECG R wave peak time node. The pulse trigger signal is output when the first discharge sequence or the second discharge sequence arrives.

3. The pulse ablation system according to claim 1, characterized in that, The sub-control system includes a sub-main control module and a gating interlock module connected to the sub-main control module via signals; the electrode selection module includes a high-voltage switching unit, and the sub-main control module is used to receive the channel gating command from the main control system and drive the high-voltage switching unit to conduct; when the gating interlock module detects that two or more sub-control systems send gating enable signals to the same ablation electrode in the ablation electrode module, the gating interlock module pulls the gating enable signal low to zero level and blocks the transmission circuit of the pulse trigger signal, while reporting a channel conflict fault signal to the main control system.

4. The pulse ablation system according to claim 1, characterized in that, The impedance measurement module is also used to apply an AC excitation signal to the ablation electrode pair again after the high-voltage generation module completes the ablation pulse release, and extract and calculate the post-ablation damage impedance. The main control system is used to calculate the ratio of the post-ablation damage impedance to the pure resistance contact impedance. When the ratio is between 0.70 and 0.80, it is determined that the ablated tissue has formed an effective irreversible electroporation injury. When the ratio is greater than 0.80, the main control system is used to issue an additional ablation prompt command and limit the cumulative number of ablation discharges at the same ablation location to no more than 4 times. The threshold value for the determination of irreversible electroporation injury can be preset according to the characteristics of the target ablated tissue. The main control system is also used to maintain the high-voltage lockout state and issue a poor contact alarm signal before ablation discharge when the pure resistance contact impedance is not in the set contact range, so as to prompt the adjustment of the contact position of the ablation catheter.

5. The pulse ablation system according to claim 1, characterized in that, The sub-control system includes a high-voltage pulse generation module and a half-bridge isolated power supply module. The high-voltage pulse generation module includes a half-bridge drive unit and a power switch unit. The half-bridge isolated power supply module is used to convert the input power supply into a 15V positive bias drive voltage and a -4V negative bias turn-off voltage for use by the half-bridge drive unit. The half-bridge drive unit is used to convert the low-voltage control level of the sub-control system into a high-voltage drive level, driving the power switch unit to turn on or off, so as to output a high-voltage pulse waveform to the ablation electrode module.

6. The pulse ablation system according to claim 1, characterized in that, An opto-isolation module is provided between the sub-control system and the main control system. The opto-isolation module is used to electrically isolate the high-voltage control commands issued by the main control system and the impedance data uploaded by the sub-control system, so as to prevent mutual interference between the sub-control system and the main control system during the high-voltage ablation process, and to cut off the transmission path of common-mode interference generated by the high-voltage generating module during pulse discharge to the main control system.

7. The pulse ablation system according to claim 1, characterized in that, The main control system includes a high-voltage power supply measurement module and a discharge protection module. The high-voltage power supply measurement module is used to collect the output voltage and output current of the high-voltage generator module in real time. When the deviation between the collected output voltage and the set ablation voltage exceeds the set voltage error range, or when the collected output current exceeds the set overcurrent threshold, the main control system is used to cut off the high-voltage enable signal and control the discharge protection module to connect the energy discharge circuit of the high-voltage energy storage unit.

8. The pulse ablation system according to claim 1, characterized in that, The external ECG signal input module is used to connect to the ECG acquisition module. The main control system is used to perform threshold cross-filtering on the received ECG signal to locate the peak of the R wave, continuously extract the RR interval time series of a set number of adjacent heartbeats, and calculate the variance of the RR interval time series as the variance. When the variance is greater than the set physiological jitter threshold, the main control system is used to determine the number of milliseconds of indentation according to the direct proportional mapping relationship between the variance and the window indentation. Taking the located ECG R wave peak as the timing start point, the number of milliseconds of indentation is deducted from the preset discharge delay time to reconstruct the discharge permission time window.

9. A pulse ablation system according to claim 1, characterized in that, The pulse ablation system also includes a display module and a foot pedal control module. The display module is communicatively connected to the main control system and is used to display the ablation electrode selection topology, ablation parameters, and contact impedance alarm status. The foot pedal control module is signal-connected to the main control system and includes a high-voltage charging control unit, an ablation trigger control unit, and a forced exit control unit. When the main control system receives a trigger signal from the forced exit control unit, it blocks the high-voltage pulse output and resets the electrode selection module.

10. A pulse ablation device, characterized in that, The pulse ablation device is used to operate the pulse ablation system as described in claim 1.

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