Impedance dynamic feedback-based pulsed field ablation system and methods of use thereof

Abstract

The application provides a pulse field ablation system based on impedance dynamic feedback and a use method thereof, and the system comprises: a pulse generator module for generating voltage pulses required by pulse field ablation; an ablation catheter module comprising a plurality of ablation electrodes for transmitting the voltage pulses to heart tissue to be ablated, and the activation mode of the plurality of ablation electrodes is determined according to the depth and range of the heart tissue to be ablated; an impedance detection module comprising an impedance sensor for dynamically detecting the electrical impedance of different ranges in the ablated heart tissue; a system control module for dynamically adjusting the voltage pulses generated by the pulse generator module, the activation mode of the plurality of ablation electrodes and the detection range of the impedance sensor according to the electrical impedance of different ranges in the ablated heart tissue; and a visual interface interaction module for displaying the ablation process and serving as an operation interface of the ablation process. The application can improve the evaluation ability of the ablation effect and ensure the accuracy and success rate of the ablation process.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of electrophysiological instruments, in particular to a pulse field ablation system based on impedance dynamic feedback and a method for using the same. BACKGROUND

[0002] Arrhythmia diseases such as atrial fibrillation pose a significant threat to patients' health, as they not only increase the risk of stroke but also can lead to heart failure and other complications. In recent years, pulse field ablation technology has gradually attracted attention due to its unique working principle and significant therapeutic effect. Compared with traditional radiofrequency ablation and cryoablation technology, pulse field ablation can effectively destroy diseased tissue in a shorter time with less damage to surrounding healthy tissue. However, the current pulse field ablation technology lacks effective real-time feedback mechanisms during ablation, making it difficult for physicians to assess the ablation effect in real time, and the depth of pulse field ablation is insufficient, thereby affecting the precision and safety of treatment.

[0003] During pulse field ablation, myocardial cells produce nanoscale pores through the phenomenon of irreversible electroporation, leading to changes in the structure of the cell membrane. The inventors of the present application have found that this process is accompanied by a significant decrease in electrical impedance. If this impedance change can be monitored in real time and the activation position of the ablation electrode is dynamically adjusted, not only can the ablation effect be effectively evaluated, but also the ablation range and depth can be adjusted accordingly. However, many existing pulse field ablation systems fail to fully utilize this characteristic, lacking integrated impedance feedback design, resulting in less than ideal treatment outcomes.

[0004] Through research on existing pulse field ablation technology, it was found that the patent with application number CN202110731608.1 proposes a pulse field ablation control method and system, which only adjusts the electrical pulse parameters based on the impedance characteristics of the diseased tissue, and cannot specifically change the distribution position of the internal electric field intensity, thus the ablation range and depth effect cannot be significantly improved. In addition, the patent with application number 202411058947.8 proposes a pulse field ablation method and system for the pulmonary vein antrum, which monitors the voltage of the pulse field ablation device in real time during pulse field ablation and determines whether the voltage fluctuation of the pulse field ablation device is abnormal within the target period. The purpose is to prevent surgical interruptions and safety issues caused by abnormal system voltage fluctuations, but it does not optimize the ablation process and cannot improve the ablation effect and success rate.

[0005] The patent with authorization announcement number CN219147881U discloses a pulse ablation system, which does not explain the role of each module in the system, and the ablation catheter structure is single, cannot adjust multiple ablation electrode modes, and does not dynamically adjust ablation parameters according to tissue dynamic characteristics.

[0006] The patent with the application publication number CN118873240A discloses a device and method for real-time pulse electric field ablation evaluation based on local impedance detection. The function of measuring local impedance is only for evaluating the ablation effect. The disclosed ablation catheter module structure and mode are single, and the direction of the ablation electric field cannot be changed.

[0007] The limitations of these prior arts show that there is an urgent need for a pulse field ablation system capable of integrating a real-time impedance feedback mechanism to improve the evaluation capability of the ablation effect and increase the ablation depth. SUMMARY

[0008] In view of the defects in the prior art, the purpose of the present application is to provide a pulse field ablation system based on impedance dynamic feedback and a method for using the same.

[0009] According to one aspect of the present application, a pulse field ablation system based on impedance dynamic feedback is provided, comprising:

[0010] a pulse generator module for generating voltage pulses required for pulse field ablation;

[0011] an ablation catheter module comprising a plurality of ablation electrodes connected to the pulse generator module, the ablation electrodes being used to deliver the voltage pulses generated by the pulse generator module to the heart tissue to be ablated, so that irreversible electroporation occurs in the heart tissue, and the activation mode of the plurality of ablation electrodes is determined according to the depth and range of the heart tissue to be ablated;

[0012] an impedance detection module comprising an impedance sensor for dynamically detecting the electrical impedance of different ranges in the ablated heart tissue;

[0013] a system control module connected to the pulse generator module, the ablation catheter module and the impedance detection module, respectively, the system control module dynamically adjusting the voltage pulses generated by the pulse generator module, the activation mode of the plurality of ablation electrodes and the detection range of the impedance sensor according to the electrical impedance of different ranges in the ablated heart tissue;

[0014] a visual interface interaction module connected to the system control module, the visual interface interaction module being used to display the ablation process and serving as an operation interface for the ablation process.

[0015] Optionally, the plurality of ablation electrodes comprises a plurality of electrode portions of different shapes and / or sizes, and the plurality of electrode portions forms a plurality of partitioned electrode pair structures after being activated. The voltage pulses are delivered by activating any partitioned or combined partitioned electrode pair structure, which is suitable for ablation requirements of different depths and ranges.

[0016] Optionally, the impedance sensor has a plurality of electrode pairs, and the activation mode of the plurality of electrode pairs is determined according to the detection range of the impedance value of the ablated cardiac tissue.

[0017] Optionally, the voltage pulse generated by the pulse generator module includes any one of a unidirectional square wave pulse, a bidirectional square wave pulse, and an exponential decay pulse.

[0018] Optionally, for the unidirectional square wave pulse and the bidirectional square wave pulse, the adjustable range of the pulse voltage amplitude is 10V-10kV, the adjustable range of the number of pulses is 1-1000, the adjustable range of the pulse width and the pulse interval width is 10ns-100ms, and the adjustable range of the pulse repetition frequency is 0.1Hz-10MHz.

[0019] Optionally, for the exponential decay pulse, the adjustable range of the pulse voltage amplitude is 10V-10kV, the adjustable range of the number of pulses is 1-1000, the adjustable range of the pulse width is 10ns-100ms, the adjustable range of the pulse repetition frequency is 0.1Hz-10MHz, the adjustable range of the resistance is 10Ω-5000Ω, and the adjustable range of the capacitance is 10μF-5000μF.

[0020] Further, the system control module dynamically selects the number, position, and sequence of the activated ablation electrodes and the electrode pairs of the impedance sensor according to the preset target ablation mode and the real-time feedback electrical impedance distribution data.

[0021] Further, the electric field intensity generated by the voltage pulse generated by the pulse generator module and the activated ablation electrodes exceeds the electric field intensity threshold value at which irreversible electroporation of myocardial cells occurs, and satisfies E=U÷d>E threshold to ensure the optimization of the electric field distribution and the electric field intensity;

[0022] wherein E is the electric field intensity generated by the voltage pulse generated by the pulse generator module and the activated ablation electrodes, U is the pulse voltage amplitude, d is the electrode spacing of the activated ablation electrodes, and E threshold is the electric field intensity threshold value at which irreversible electroporation of myocardial cells occurs.

[0023] Optionally, the visualization interface interaction module includes a voltage pulse setting unit, a target ablation mode setting unit, an ablation electrode partition position distribution setting unit, and a dynamic electrical impedance distribution display unit.

[0024] According to another aspect of the present application, a use method of the above-mentioned pulse field ablation system based on impedance dynamic feedback is provided, and the method includes:

[0025] The visual interface interaction module sets a voltage pulse, a target ablation mode, a partition position distribution of an ablation electrode, and a dynamic detection frequency of an impedance sensor;

[0026] According to the target ablation position and requirements of the heart tissue, the ablation catheter module is implanted into the target position and accurately positioned;

[0027] The first partition ablation electrode pair with the largest electrode spacing is selected and activated to transmit a plurality of groups of voltage pulses with specified parameters, and the impedance distribution of the part of the tissue is measured after each group of voltage pulses according to the target ablation mode; when the impedance difference measured after applying two adjacent groups of voltage pulses is less than a set value, the ablation operation is completed;

[0028] According to the impedance distribution result, the second partition ablation electrode pair with an electrode spacing smaller than that of the first partition ablation electrode pair is selected and activated, and the same operation is repeated to complete the next ablation operation; and the process is repeated until the ablation steps required by the target ablation mode are completed;

[0029] After each ablation process, the voltage pulse parameters of the subsequent ablation steps and the activated partition electrode pair strategy are adjusted based on the impedance dynamic feedback result and the electric field intensity distribution, and the ablation depth is continuously increased to ensure the accuracy and success rate of the continuous ablation process.

[0030] Compared with the prior art, the present application has at least one of the following beneficial effects:

[0031] 1. Real-time impedance dynamic feedback: The system of the present application integrates an impedance detection module, which can monitor the electrical impedance change of the ablated heart tissue in real time, thereby effectively evaluating the ablation effect and dynamically adjusting the ablation parameters according to the feedback information;

[0032] 2. Flexible pulse voltage configuration: Through the pulse generator module, the system of the present application can generate a plurality of types of voltage pulses required to adapt to different ablation requirements;

[0033] 3. Multi-electrode configuration and dynamic activation: The ablation catheter module is designed as a plurality of ablation electrodes, and the activation mode of the ablation electrodes is determined according to the depth and range of the heart tissue to be ablated, allowing flexible activation of any partition or combined partition electrode to achieve targeted optimization of the ablation depth and range;

[0034] 4. Advanced ablation strategy: The system control module can dynamically select the most suitable electrodes and activation sequence according to the real-time impedance feedback and the preset ablation mode, further improving the accuracy of the ablation process;

[0035] 5. Visual monitoring and adjustment: The visual interface interaction module allows the operator to intuitively monitor the ablation process and adjust the program settings according to real-time data, improving the flexibility and safety of the operation.

[0036] In summary, the pulse field ablation system provided by the present application can improve the evaluation ability of ablation effect, ensure the accuracy and success rate of the ablation process, improve the effectiveness of treatment, and also enhance the real-time monitoring ability of the pulse field ablation system, fill the gap in the prior art, and provide a more effective solution for the treatment of arrhythmia. BRIEF DESCRIPTION OF DRAWINGS

[0037] Other features, objects, and advantages of the present application will become more apparent from the following detailed description of non-limiting embodiments thereof as read in conjunction with the accompanying drawings:

[0038] Figure 1 a structural block diagram of the pulse field ablation system based on impedance dynamic feedback in an embodiment of the present application;

[0039] Figure 2 a flowchart of the use method of the pulse field ablation system based on impedance dynamic feedback in an embodiment of the present application;

[0040] Figure 3 a schematic diagram of electrode setting and ablation result of the pulse field ablation process 1 based on impedance dynamic feedback in an embodiment of the present application;

[0041] Figure 4 a schematic diagram of electrode setting and ablation result of the pulse field ablation process 2 based on impedance dynamic feedback in an embodiment of the present application;

[0042] Figure 5 a schematic diagram of electrode setting and ablation result of the pulse field ablation process 3 based on impedance dynamic feedback in an embodiment of the present application. DETAILED DESCRIPTION

[0043] The present application will be described in detail below with specific embodiments. The following embodiments will help those skilled in the art to further understand the present application, but do not limit the present application in any form. It should be noted that for those skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made. These all belong to the protection scope of the present application.

[0044] REFERENCE Figure 1As shown, the embodiment of the present application provides an impedance dynamic feedback based pulsed field ablation system, which comprises a pulse generator module, an ablation catheter module, an impedance detection module, a system control module and a visual interface interaction module, wherein: the pulse generator module is used to generate voltage pulses required by pulsed field ablation; the ablation catheter module comprises a plurality of ablation electrodes connected with the pulse generator module, the ablation electrodes are used to transmit the voltage pulses generated by the pulse generator module to the heart tissue to be ablated, so that irreversible electroporation occurs in the heart tissue; the activation mode of the plurality of ablation electrodes, i.e. the number and position of the activated electrodes, is determined according to the depth and range of the heart tissue to be ablated; the impedance detection module comprises an impedance sensor, the impedance sensor is used to dynamically detect the electrical impedance of different ranges of the ablated heart tissue; the position of the impedance sensor is in the ablation catheter module, and the impedance sensor is in contact with the heart tissue to dynamically detect the electrical impedance during operation; the system control module is connected with the pulse generator module, the ablation catheter module and the impedance detection module respectively, and the system control module dynamically adjusts the voltage pulses generated by the pulse generator module, the activation mode of the plurality of ablation electrodes and the detection range of the impedance sensor according to the electrical impedance of different ranges of the ablated heart tissue; the visual interface interaction module is connected with the system control module, and the visual interface interaction module is used to display the ablation process and serve as an operation interface of the ablation process.

[0045] In some embodiments, the plurality of ablation electrodes comprises a plurality of electrode portions of different shapes and / or sizes, and the plurality of electrode portions can form a plurality of partitioned electrode pairs after being activated, and a plurality of electrode pairs can be activated to form a combined partitioned electrode pair. For a target ablation region of the heart tissue, an ablation scar is formed after ablation, and the distribution range of the ablation scar on the surface of the heart is referred to as an ablation range, and the depth of the ablation scar in the heart is referred to as an ablation depth. Voltage pulses are transmitted by activating any partitioned or combined partitioned electrode pair structure, i.e. flexibly activating the electrode portions of the ablation catheter according to the partition, to adapt to the ablation requirements of different depths and ranges.

[0046] The impedance detection module mainly comprises an impedance sensor and an impedance detection circuit, which are used to dynamically detect the electrical impedance of different regions of the ablated heart tissue at different alternating current signal frequencies (i.e. the dynamic detection frequency of the impedance sensor). In some embodiments, the impedance sensor has a plurality of electrode pairs, and the activation mode of the plurality of electrode pairs is determined according to the detection range of the impedance value of the ablated heart tissue, and the activation mode of the plurality of electrode pairs refers to the number and position of the activated electrode pairs. By designing the impedance detection module to have a plurality of electrode pairs, the detection range can be flexibly selected.

[0047] The system in the embodiment of the present application integrates the impedance detection module, can monitor the electrical impedance change of the ablated heart tissue in real time, realizes real-time impedance dynamic feedback, thereby effectively evaluates the ablation effect, and dynamically adjusts the ablation parameters according to the feedback information.

[0048] The pulse generator module mainly contains power supply circuit, energy storage element, pulse generation circuit, which is used to generate various types of voltage pulses required for pulse field ablation. In some embodiments, the voltage pulses generated by the pulse generator module include any one of unidirectional square wave pulse, bidirectional square wave pulse and exponential decay pulse, with adjustable voltage amplitude, pulse number, width and frequency, etc.

[0049] Pulse field ablation is a non-thermal energy ablation technique, which mainly acts on the cell membrane through high-voltage electric pulses, causing irreversible permeable damage to the cell membrane, thereby achieving ablation effect. The pulse voltage amplitude affects the electric field strength, and the electric field strength is the basis for electroporation to act on the tissue. The stronger the delivered electric field, the greater the impact on the target tissue. But with the increase of electric field strength, the risk of heat generation will also increase, thus leading to the transformation of thermal effect. Therefore, higher output voltage means higher field strength and possibly greater damage range, but also increases the risk of safety, such as thermal effect, contraction of skeletal muscle, formation of microbubbles, and even appearance of electric arc. Increasing the number of pulses usually increases the overall effect observed, and some single-cell data suggest that when more than 16 pulses are applied, there is no significant difference in permeability or 50% cell population death. For pulse width, the increase of pulse duration will produce greater electroporation effect on cells; for longer pulses, lower voltage is required to maintain the same number of electroporated cells, especially when the duration is less than 1 millisecond, higher voltage is required to achieve the same effect, but too large pulse duration increases the risk of thermal effect. The pulse interval width affects the pulse repetition frequency, i.e. the time interval between pulses, and electroporation relies on pulse repetition rate. Pulse repetition frequency refers to the number of pulse repetitions per unit time, and increasing the pulse repetition frequency usually increases the overall effect observed.

[0050] The above parameters jointly determine the effect of pulse field ablation, and there is a complex interaction between the parameters, and the specific value of each parameter depends on the specific ablation target and tissue characteristics.

[0051] In some embodiments, for unidirectional square wave pulse and bidirectional square wave pulse, the adjustable range of pulse voltage amplitude is 10V-10kV, the adjustable range of pulse number is 1-1000, the adjustable range of pulse width and pulse interval width is 10ns-100ms, and the adjustable range of pulse repetition frequency is 0.1Hz-10MHz.

[0052] In some embodiments, for the exponential decay pulse, the adjustable range of the pulse voltage amplitude is 10V-10kV, the adjustable range of the pulse number is 1-1000, the adjustable range of the pulse width is 10ns-100ms, the adjustable range of the pulse repetition frequency is 0.1Hz-10MHz, the adjustable range of the resistance is 10Ω-5000Ω, and the adjustable range of the capacitance is 10μF-5000μF.

[0053] Exemplarily, the voltage pulse generated by the pulse generator module is a unidirectional square wave pulse, wherein a plurality of pulse parameters are independently and arbitrarily adjustable. The pulse voltage amplitude is 300V, the pulse number is 100, the pulse width is 100μs, and the pulse repetition frequency is 1Hz.

[0054] Through the pulse generator module, the system in the embodiment of the present application can generate a plurality of types of voltage pulses required, and the system has flexible pulse voltage configuration and can adapt to different ablation requirements.

[0055] In the above embodiment of the present application, the system control module dynamically selects the most suitable partitioned ablation electrode and activation sequence according to the preset target ablation mode and the real-time feedback electrical impedance distribution data, that is, the activation number, position and sequence of the activated ablation electrode and the electrode pair of the impedance sensor. The preset target ablation mode includes a transmural damage mode (causing a penetrating damage to the heart), a deep damage mode (causing a damage to the deep tissue on one side of the surface of the heart but not transmurally), a superficial damage mode (causing a damage to the superficial layer on one side of the heart), etc. According to the characteristics (including the electrical impedance distribution and the ablation electrode position) of different regions of the ablated heart tissue, the feedback is controlled and dynamically adjusted to further improve the accuracy of the ablation process. The ablation parameters such as the activation mode of the voltage pulse, the impedance sensor and the ablation electrode.

[0056] In the above embodiment of the present application, the electric field strength generated by the voltage pulse generated by the pulse generator module and the activated ablation electrode exceeds the electric field strength threshold value at which irreversible electroporation of myocardial cells occurs, that is, E=U÷d>E threshold to ensure the optimization of the electric field distribution and the electric field strength.

[0057] E is the electric field strength generated by the voltage pulse and the activated ablation electrode; U is the pulse voltage amplitude; d is the electrode spacing of the activated ablation electrode; E threshold is the electric field strength threshold value at which irreversible electroporation of myocardial cells occurs, and is commonly valued at 400V / cm.

[0058] In some embodiments, the visual interface interaction module includes a voltage pulse setting unit, a target ablation mode setting unit, an ablation electrode partition position distribution setting unit, and a dynamic electrical impedance distribution display unit. The visual interface interaction module provides real-time monitoring and adjustment functions for the operator. With the help of the visual interface interaction module, the system operator can intuitively monitor the ablation process and can adjust the parameters in the ablation process according to the ablation process, thereby improving the flexibility and safety of the operation.

[0059] In the system in the above embodiments of the present application, the ablation electrodes in the ablation catheter module include a plurality of electrode pairs, which are divided into a plurality of, for example, three, partition electrode pairs, and are distributed in different ranges of the ablated cardiac tissue, so that any partitioned ablation electrode pair can be flexibly activated to transmit a voltage pulse to adapt to the ablation requirements of different depths and ranges. The impedance sensor in the impedance detection module is of a structure with a plurality of electrode pairs, which can be flexibly selected to detect the impedance values of the tissue in different ranges and fed back to the system control module. The ablation catheter module and the impedance detection module are in contact with the cardiac tissue to realize the transmission of electric pulses and electrical impedance detection. The system control module generates system control signals for the impedance detection module and the like. In the embodiments of the present application, the impedance sensor in the impedance detection module dynamically detects the electrical impedance of different regions in the ablated cardiac tissue, so that the system control module controls and dynamically adjusts the activation mode of the voltage pulse and the plurality of partitioned ablation electrodes and the ablation electric pulse parameters according to the impedance characteristics of different regions in the ablated cardiac tissue. The visual interface interaction module can also facilitate the system operator to intuitively monitor the ablation process and can adjust the program settings according to the ablation process. By integrating various voltage pulse types and real-time impedance monitoring mechanisms, the modules cooperate with each other to dynamically evaluate the ablation effect and optimize the treatment parameters and the activated ablation electrode configuration, which can improve the evaluation ability of the ablation effect, significantly improve the precision of the ablation process and the ablation depth, improve the effectiveness of the treatment, and also enhance the real-time monitoring capability of the pulse field ablation system. The system in the above embodiments of the present application provides a more effective solution for the treatment of arrhythmia.

[0060] Referring to Figure 2 Another embodiment of the present application provides a use method of the above-mentioned pulse field ablation system based on impedance dynamic feedback, which comprises the following steps:

[0061] S1, before the system is used, some pre-setting work is carried out, the voltage pulse (including the type and parameters of the voltage pulse) is set in the visual interface interaction module, the target ablation mode (such as transmural lesion), the partition position distribution of the ablation electrode and the dynamic detection frequency of the impedance sensor (for example, 1000 Hz); different detection frequencies will cause the impedance value of the equivalent inductance and capacitance in the detected tissue to change, the impedance of the inductance increases with the increase of the frequency, and the impedance of the capacitance decreases with the increase of the frequency, that is, the impedance will also be different under different detection frequencies;

[0062] S2, according to the target ablation position and requirement of the heart tissue, the ablation catheter module is implanted into the target position atrium and accurately positioned;

[0063] S3, the first partition ablation electrode pair with the largest electrode spacing is selected and activated to deliver multiple groups of voltage pulses with specified parameters, and the impedance distribution of the part of the tissue is measured after each group of voltage pulses according to the target ablation mode; according to the impedance distribution result of the part of the tissue, when the impedance difference measured after applying adjacent two groups of voltage pulses is less than a set value, the ablation operation is completed;

[0064] S4, according to the impedance distribution result, the second partition ablation electrode pair with one smaller electrode spacing than the first partition ablation electrode pair in step S3 is selected and activated, and the same operation is repeated to complete the next ablation operation; in this way, the ablation steps required by the target ablation mode are completed;

[0065] S5, the voltage pulse is transmitted to the heart tissue through the ablation electrode to generate a specific size and position of the electric field intensity and distribution on the tissue. For the same ablation electrode, changing the voltage size of the electric pulse can produce different sizes of electric field intensity distribution; and for the same electric pulse parameters, changing the number and / or position of the ablation electrode pair can produce different sizes and directions of electric field intensity distribution. After each ablation process, based on the impedance dynamic feedback result and the electric field intensity distribution (the voltage pulse generated by the pulse generator module and the activated ablation electrode cooperate to produce), the voltage pulse parameters of the subsequent ablation step and the activated partition electrode pair strategy are adjusted to continuously increase the ablation depth, so as to ensure the accuracy and success rate of the continuous ablation process.

[0066] For the above steps S3 and S4, further explanation is made in combination with the drawings.

[0067] For the ablation electrode including a plurality of different shapes and sizes, the embodiment of the application enables different partition electrodes layer by layer, and different electrode pairs with different spacings and positions can be activated, so that different sizes and positions of ablation results are achieved.

[0068] First, the ablation electrode pair with the largest electrode spacing is activated as shown in FIG. 2, and the voltage pulse with the specified parameters is delivered to the target ablation position of the heart tissue through the ablation electrode pair, and the impedance distribution of the part of the tissue is measured after each group of voltage pulses according to the target ablation mode. Figure 3The electrode pair shown (electrode setting 1) activates the two outermost electrodes (ablation process 1), resulting in a larger scar area but a smaller depth after ablation (ablation result 1). The impedance sensor detects a decrease in tissue impedance in ablation area 1 within ablation result 1, which is beneficial for current transmission. This dynamic impedance result is fed back to the system control module.

[0069] Furthermore, activate such Figure 4 The electrode pair shown (electrode setup 2), namely two electrodes with a reduced spacing (ablation process 2), results in a smaller scar area but a significantly increased depth after ablation due to the decreased tissue conductivity and shrinking activated electrode pair area in the ablation result 1 (ablation result 2) generated in the first step. Impedance sensor detection shows a further reduction in tissue impedance in the ablation region 2 in ablation result 2, which is beneficial for current transmission. This dynamic impedance result is fed back to the system control module.

[0070] Finally, activate as Figure 5 The electrode pair shown (electrode setting 3) activates the two innermost electrodes respectively (ablation process 3). As the tissue conductivity in the ablation scar generated in the first two steps decreases and the range of the activated electrode pair further shrinks, the final scar area is further reduced, and transmural damage to the heart tissue is achieved (ablation result 3).

[0071] Therefore, through impedance dynamic feedback and the layer-by-layer activation of ablation electrodes, transmural pulsed field ablation of cardiac tissue can be achieved.

[0072] The method of using the system described above includes setting ablation parameters, precisely locating the ablation catheter, applying voltage pulses and detecting impedance, and dynamically adjusting subsequent operations based on feedback results to ensure the accuracy and success rate of the ablation process. This invention provides a novel and efficient ablation technique for the treatment of heart diseases.

[0073] Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various modifications or variations within the scope of the claims, which do not affect the essence of the present invention. The above preferred features can be used in any combination without conflict.

Claims

1. An impedance dynamic feedback based pulsed field ablation system, characterized in that, The system comprises: a pulse generator module for generating voltage pulses required for pulsed field ablation; an ablation catheter module comprising a plurality of ablation electrodes connected to the pulse generator module, the ablation electrodes being used to deliver the voltage pulses generated by the pulse generator module to the heart tissue to be ablated so that irreversible electroporation occurs in the heart tissue, the activation mode of the plurality of ablation electrodes being determined according to the depth and range of the heart tissue to be ablated; an impedance detection module comprising an impedance sensor for dynamically detecting the electrical impedance of different ranges of the ablated heart tissue; a system control module connected to the pulse generator module, the ablation catheter module and the impedance detection module, respectively, the system control module dynamically adjusting the voltage pulses generated by the pulse generator module, the activation mode of the plurality of ablation electrodes and the detection range of the impedance sensor according to the electrical impedance of different ranges of the ablated heart tissue; a visual interface interaction module connected to the system control module, the visual interface interaction module being used to display the ablation process and serving as an operation interface for the ablation process.

2. The impedance-dynamically feedback-based pulsed field ablation system of claim 1, wherein, The plurality of ablation electrodes comprises a plurality of electrode portions of different shapes and / or sizes, the plurality of electrode portions forming a plurality of partitioned electrode pair structures after being activated, and the voltage pulses being delivered by activating any partitioned or combined partitioned electrode pair structure, thereby adapting to the ablation requirements of different depths and ranges.

3. The impedance-dynamically feedback-based pulsed field ablation system of claim 1, wherein, The impedance sensor has a plurality of electrode pairs, and the activation mode of the plurality of electrode pairs is determined according to the detection range of the impedance value of the ablated heart tissue.

4. The impedance-dynamically feedback-based pulsed field ablation system of claim 1, wherein, The voltage pulses generated by the pulse generator module include any one of unidirectional square wave pulses, bidirectional square wave pulses and exponential decay pulses.

5. The impedance-dynamically feedback-based pulsed field ablation system of claim 4, wherein, For the unidirectional square wave pulses and the bidirectional square wave pulses, the adjustable range of the pulse voltage amplitude is 10 V-10 kV, the adjustable range of the number of pulses is 1-1000, the adjustable range of the pulse width and the pulse interval width is 10 ns-100 ms, and the adjustable range of the pulse repetition frequency is 0.1 Hz-10 MHz.

6. The impedance-dynamically feedback-based pulsed field ablation system of claim 4, wherein, For the exponential decay pulses, the adjustable range of the pulse voltage amplitude is 10 V-10 kV, the adjustable range of the number of pulses is 1-1000, the adjustable range of the pulse width is 10 ns-100 ms, the adjustable range of the pulse repetition frequency is 0.1 Hz-10 MHz, the adjustable range of the resistance is 10 Ω-5000 Ω, and the adjustable range of the capacitance is 10 μF-5000 μF.

7. The impedance-dynamically feedback-based pulsed field ablation system of claim 1, wherein, The system control module dynamically selects the number, position and sequence of the activated ablation electrodes and the electrode pairs of the impedance sensor according to the preset target ablation mode and the real-time feedback electrical impedance distribution data.

8. The impedance-dynamically feedback-based pulsed field ablation system of claim 1, wherein, The voltage pulses generated by the pulse generator module and the activated ablation electrode together generate an electric field intensity that exceeds the electric field intensity threshold at which irreversible electroporation of cardiomyocytes occurs, satisfying E = U ÷ d > E threshold to ensure optimization of the electric field distribution and electric field intensity; wherein, E is the electric field strength resulting from the combination of both the voltage pulse and the activated ablation electrode; U is the pulse voltage amplitude; d is the electrode spacing of the activated ablation electrode; E threshold is the electric field strength threshold at which irreversible electroporation of cardiomyocytes occurs.

9. The impedance-dynamically feedback-based pulsed field ablation system of claim 1, wherein, The visual interface interaction module comprises a voltage pulse setting unit, a target ablation mode setting unit, an ablation electrode partition position distribution setting unit and a dynamic electrical impedance distribution display unit.

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