A device, method, equipment, and medium for evaluating the depth of pulsed electric field cardiac ablation

Abstract

The present invention provides a pulsed electric field cardiac ablation depth evaluation device, method, equipment, and medium. The device includes a switch switching module, a timer, an impedance measurement module, an ablation depth processing unit, and an ablation depth display module. The evaluation device and method can provide an ablation depth evaluation result 5 minutes after treatment, can complete ablation evaluation during the operation, has significant time advantages, and has good real-time performance. Through the impedance measurement module and the ablation depth processing unit, the ablation depth can be accurately evaluated and displayed in a three-dimensional image, which is convenient for doctors to quickly judge the surgical treatment process and has a high degree of accurate quantification. The device and its evaluation method can be used in combination with various ablation catheters, and are applicable to the treatment scenarios of atrial fibrillation in shallow tissues and ventricular tachycardia in deeper tissues, with strong applicability.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a pulsed electric field cardiac ablation depth evaluation device, method, equipment, and medium. Background Art

[0002] Pulsed electric field ablation (PFA) applies high-voltage electric pulses in microseconds or nanoseconds to myocardial tissue, causing irreversible electroporation of cell membranes, thereby leading to the death of myocardial cells and achieving the purpose of eliminating arrhythmia foci. Clinical data shows that pulsed electric field ablation (PFA) is an effective means for treating arrhythmia, and the ablation depth is a key factor in evaluating the success of PFA treatment. The ablation depth needs to accurately cover lesions from small lesions in superficial arrhythmias to deeper lesions of scar-mediated intramural arrhythmias, so as to avoid under-treatment or over-treatment. Under-treatment cannot achieve the effect of isolating stray electrical signals, while over-treatment will increase several risks related to ablation treatment, including unnecessary damage to normal tissues, the occurrence of thermal effects, increased skeletal muscle contraction, the formation of microbubbles, and even the occurrence of arcs.

[0003] The target tissues of clinical cardiac ablation vary greatly in depth. The depth of the deep pulmonary vein tissue or the posterior wall of the left atrium is less than 2 mm, the thickness of the left atrial ridge and top is 5 - 7 mm, the thickness of the tricuspid isthmus line in the right atrial cavity is as high as 10 mm, and the thickness of some areas of the left ventricle exceeds 10 mm.

[0004] However, there is currently no gold standard for clinically real-time monitoring of ablation depth. Clinical treatment usually uses the disappearance of chaotic cardiac signals to determine the progress of the operation. However, the significant weakening of electrocardiogram signals caused by cell dizziness after the action of pulsed electric fields significantly interferes with clinical results. Traditional imaging methods, such as intracardiac ultrasound, computed tomography, magnetic resonance imaging, etc., cannot display the ablation area during ablation, so the progress of the operation cannot be judged.

[0005] The ablation effect of pulsed electric fields can be monitored in the following ways:

[0006] For example, Chinese Patent No. CN104114098B, with the invention name of a system for evaluating the effect of ablation treatment on cardiac tissue using photoacoustics, proposes to use photoacoustics to evaluate the ablation effect of cardiac tissue. This patent uses an electromagnetic radiation emitter such as an optical fiber to deliver electromagnetic radiation to the tissue and induce a photoacoustic response from the tissue, thereby evaluating the effect of ablation treatment on cardiac tissue. However, this method requires additional configuration of a slender deformable shaft rod and components such as an electromagnetic radiation emitter and an ultrasonic transducer arranged in the shaft rod, which brings practical difficulties to doctors using PFA catheters for cardiac ablation.

[0007] The Chinese patent with the publication number CN118873240A and the invention title of "A Device and Method for Real-Time Pulse Electric Field Ablation Evaluation Based on Local Impedance Detection" conducts real-time pulse electric field ablation evaluation through local impedance detection and establishes a quantitative correspondence between the local impedance detection results and pulse electric field ablation. However, this solution cannot provide a quantitative ablation range, and in addition to the ablation electrode group, impedance detection electrodes need to be arranged separately. Different from the above two technologies, this device does not require additional invasive devices and directly uses the PFA ablation catheter in situ to collect impedance spectra for ablation depth evaluation.

[0008] The Chinese patent with the publication number CN115737111A and the invention title of "An Energy Control Method, System and Ablation System Based on Wall Thickness and Impedance" discloses an energy control method, system and ablation system based on wall thickness and impedance. This patent calculates the wall thickness index based on the tissue wall thickness during pulsed ablation, calculates the catheter apposition state parameter based on the impedance measurement of different electrodes, and controls the output of ablation energy according to the wall thickness index and catheter apposition state parameter. This method can achieve the purpose of preoperative planning and complete the planning of a single treatment plan. However, for the actual complex clinical situation, the preset pulse parameters often cannot achieve the isolation of electrocardiogram signals, and secondary pulse treatment is required. And this solution cannot diagnose the current ablation effect to guide the next pulse treatment.

[0009] The Chinese patent with the publication number CN109875678A and the invention title of "Device and Evaluation Method for Dynamic Real-Time Evaluation of Irreversible Electroporation Tissue Ablation Effect" uses multiple electrode pairs to measure impedance spectra during irreversible electroporation tumor treatment, and establishes a connection between the established model and the actual ablation size, so as to solve the problem of immediate evaluation of the treatment effect. This method can mainly evaluate the boundary of the ablation area based on the multi-needle electrode arrangement.

[0010] The Chinese patent with the publication number CN119138872A and the invention title "Method and Device for Evaluating Irreversible Electroporation Ablation Effect Based on Bioimpedance Analysis" provides a method for evaluating irreversible electroporation ablation effect based on bioimpedance analysis. Based on the impedance values of the tissue under test at a set frequency and the impedance values of the tissue after ablation, the effect of different pulse parameters can be evaluated through impedance changes. The Chinese patent with the publication number CN107635463B and the invention title "Contact Quality Evaluation through Dielectric Property Analysis" discloses devices and methods for evaluating tissue contact based on dielectric properties or impedance. The measured impedance is used to judge the contact force between the tissue and the catheter during cardiac ablation, guiding the start of the ablation procedure. The Chinese patent with the publication number CN114502067A and the invention title "Lesion Evaluation Using Peak-to-Peak Impedance Amplitude Measurement" discloses a method and system for evaluating lesion formation in tissue during an ablation procedure. The ablation effect is determined by the decrease in impedance before and after the ablation process. The Chinese patent with the publication number CN116999147A and the invention title "An Ablation State Evaluation System" acquires the impedance information of the tissue at the ablation site before and after energy delivery in real time at different frequencies, and combines the spatial position of the energy delivery electrode to obtain the energy delivery difference index of the ablation path. The positions that do not reach the ablation effect are ablated continuously according to the energy delivery difference index. None of the above four patents establish a quantitative relationship between impedance and ablation depth or area.

[0011] In addition, the Chinese patent with the publication number CN117281609A and the invention title "A Tissue Impedance Monitoring Ablation Catheter Device and a Prediction Method for Ablation Damage" discloses a device for detecting the radiofrequency ablation effect based on a radiofrequency ablation catheter according to the impedance change of local tissue.

[0012] The following deficiencies exist in the above related technologies:

[0013] It is impossible to evaluate the ablation depth of cardiac PFA in real time, resulting in unclear treatment effects;

[0014] The evaluation method is not precise enough to quantify the ablation depth;

[0015] The applicability is limited and cannot adapt to different types of ablation catheters and different-depth cardiac ablation treatment scenarios;

[0016] An additional device is required, increasing the operation difficulty for doctors.

[0017] Therefore, it is necessary to provide a new way to solve the above technical problems. Summary of the Invention

[0018] To achieve the above objects and other advantages of the present invention, the first object of the present invention is to provide a method for evaluating the ablation depth of pulsed electric field cardiac ablation, including the following steps:

[0019] Obtain the impedance spectrum of the target area of the patient's heart before pulsed electric field treatment, denoted as the initial broadband impedance spectrum;

[0020] Obtain the impedance spectrum of the target area of the patient's heart after pulsed electric field treatment, denoted as the post-pulse broadband impedance spectrum;

[0021] Input the initial broadband impedance spectrum and the post-pulse broadband impedance spectrum into an evaluation model to obtain an ablation depth evaluation result;

[0022] Display the ablation depth result in the current three-dimensional model of tissue ablation depth;

[0023] Judge whether the ablation depth result reaches transmurality to determine to stop performing pulsed electric field ablation operation.

[0024] Further, the step of inputting the initial broadband impedance spectrum and the post-pulse broadband impedance spectrum into an evaluation model to obtain an ablation depth evaluation result includes:

[0025] Perform Cole-Cole model fitting based on the broadband impedance spectrum, and the fitting formula is:

[0026] ;

[0027] Extract the indexes in the models before and after pulsed treatment respectively through fitting and for calculating impedance index , The calculation formula of which is:

[0028] ;

[0029] Confirm the ablation depth corresponding to from the ablation depth quantitative curve and output the ablation depth.

[0030] Further, the ablation depth quantitative curve is preset in the database.

[0031] Further, the step of judging whether the ablation depth result reaches transmurality to determine to stop performing pulsed electric field ablation operation includes:

[0032] When the ablation depth does not reach transmural ablation of the target area of the heart, control to perform the next pulsed electric field ablation operation;

[0033] When the ablation depth reaches transmural ablation of the target area of the heart, stop performing pulsed electric field ablation operation.

[0034] The second object of the present invention is to provide a device for evaluating the ablation depth of pulsed electric field on the heart, which applies the above method and includes a switch switching module, a timer, an impedance measurement module, an ablation depth processing unit, and an ablation depth display module; wherein,

[0035] The switch switching module is used to switch between the pulse generator and the impedance measurement module;

[0036] The impedance measurement module is used to measure the impedance spectrum of the target area of the patient's heart;

[0037] The timer is used to control the measurement time of the impedance measurement module;

[0038] The ablation depth processing unit is used to extract impedance indexes by calling an evaluation model according to the impedance spectra measured before and after pulsed electric field treatment, confirm the ablation depth corresponding to the impedance indexes from the ablation depth quantitative curve, and output it to the ablation depth display module;

[0039] The ablation depth display module is used to display the ablation depth in the current three-dimensional model of tissue ablation depth, and judge whether the ablation depth result reaches transmurality. According to the judgment result, a signal is sent to the switch switching module to make the switch switching module switch to the pulse generator to perform the next pulsed electric field ablation operation, or display information indicating to stop performing the pulsed electric field ablation operation according to the judgment result.

[0040] Further, the measurement frequency of the impedance measurement module includes components from 100 Hz to 1 MHz, the peak-to-peak value of the measured AC voltage is not greater than 5 V, the number of sampling points is not less than 8, and they are distributed in the measurement frequency range in a logarithmic function.

[0041] Further, the ablation depth processing unit performs Cole-Cole model fitting based on the broadband impedance spectrum, and the fitting formula is:

[0042] ;

[0043] By fitting, the indexes in the models before and after pulsed treatment are respectively extracted and for calculating the impedance index , The calculation formula of

[0044] .

[0045] Further, the ablation depth quantitative curve is pre-stored in a database, and the database is placed in the ablation depth processing unit.

[0046] The third object of the present invention is to provide a computer device, including a memory, a processor, and a computer program stored on the memory and executable on the processor. When the processor executes the computer program, the steps of the above method are implemented.

[0047] The fourth object of the present invention is to provide a computer-readable storage medium, on which a computer program is stored. When the computer program is executed by a processor, the steps of the above method are implemented.

[0048] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0049] The present invention provides a pulsed electric field cardiac ablation depth evaluation device, method, equipment, and medium. The evaluation device and method can provide an ablation depth evaluation result 5 minutes after treatment, can complete ablation evaluation during the operation, has significant time advantages, and has good real-time performance. Through the impedance measurement module and the ablation depth processing unit, the ablation depth can be accurately evaluated and displayed in a three-dimensional image, which is convenient for doctors to quickly judge the surgical treatment process and has a high degree of precise quantification. The device and its evaluation method can be used in combination with various ablation catheters, and are suitable for the treatment scenarios of atrial fibrillation in shallow tissues and ventricular tachycardia in deeper tissues at the same time, with strong applicability.

[0050] The above description is only an overview of the technical solution of the present invention. In order to be able to understand the technical means of the present invention more clearly and implement it in accordance with the content of the specification, the following takes the preferred embodiments of the present invention and combines with the accompanying drawings to describe in detail as follows. The specific implementation manner of the present invention is given in detail by the following embodiments and their accompanying drawings. Description of the Drawings

[0051] The drawings described herein are used to provide a further understanding of the present invention, form a part of this application, and the schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0052] Figure 1 It is a schematic diagram of a pulsed electric field cardiac ablation depth evaluation device;

[0053] Figure 2 It is a schematic diagram of initial impedance spectrum acquisition before pulsed electric field treatment;

[0054] Figure 3 It is a schematic diagram of post-pulse impedance spectrum acquisition after pulsed electric field treatment;

[0055] Figure 4 It is a schematic diagram of the measured impedance spectrum and the fitted impedance spectrum;

[0056] Figure 5 It is a schematic diagram of the working principle of the ablation depth processing unit;

[0057] Figure 6 Schematic diagram of a quantitative curve for evaluating ablation depth by impedance

[0058] Figure 7 Flowchart of the operation of a device for evaluating the ablation depth of pulsed electric field cardiac ablation

[0059] Figure 8 Flowchart of a method for evaluating the ablation depth of pulsed electric field cardiac ablation

[0060] Figure 9 Flowchart of ablation depth evaluation

[0061] Figure 10 Flowchart for judging the transmurality of ablation depth

[0062] Figure 11 Schematic diagram of a computer device

[0063] Figure 12 Schematic diagram of a computer-readable storage medium Detailed implementation manners

[0064] Next, in combination with the accompanying drawings and specific implementation manners, the present invention will be further described. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. It should be noted that, on the premise of no conflict, the following described embodiments or technical features can be arbitrarily combined to form new embodiments.

[0065] Based on the embodiments in the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0066] In the present application, the accompanying drawing numbers are only used to distinguish each step in the solution, and are not used to limit the execution order of each step. The specific execution order shall be subject to the description in the specification.

[0067] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments, and are not intended to limit the present invention.

[0068] Compared with the existing PFA ablation evaluation scheme, the present invention does not add additional invasive devices, and is based on the broadband impedance spectrum collected in situ and in real time by the PFA ablation catheter. The ablation depth is quantified during ablation to assist the doctor in judging the treatment progress of cardiac ablation. Embodiment 1

[0069] A device for evaluating the ablation depth of pulsed electric field cardiac ablation, used to evaluate the ablation depth of pulsed electric field ablation (PFA), and can evaluate the ablation depth of PFA cardiac ablation during surgery, such asFigure 1 As shown, the device includes a switch switching module, a timer, an impedance measurement module, an ablation depth processing unit, and an ablation depth display module; among them,

[0070] The switch switching module is used to switch between the pulse generator and the impedance measurement module;

[0071] Specifically, one end of the switch switching module is connected to the pulse generator and the timer through a wire, and the other end is connected to the patient and voltage and current monitoring through an ablation catheter. The function of the switch switching module is to quickly switch between pulsed electric field treatment and impedance measurement. When the switch is switched to the pulse generator, pulsed electric field cardiac ablation can be performed on the patient. When the switch is switched to the impedance measurement module, impedance spectrum measurement can be performed on the ablation area of the patient.

[0072] The impedance measurement module is used to perform impedance spectrum measurement on the target area of the patient's heart;

[0073] The timer is used to control the measurement time of the impedance measurement module;

[0074] The ablation depth processing unit is used to extract impedance indicators by calling an evaluation model according to the impedance spectra measured before and after pulsed electric field treatment, confirm the ablation depth corresponding to the impedance indicators from the ablation depth quantitative curve, and output it to the ablation depth display module;

[0075] The ablation depth display module is used to display the ablation depth in the current three-dimensional model of tissue ablation depth, and judge whether the ablation depth result reaches transmurality. According to the judgment result, a signal is sent to the switch switching module to make the switch switching module switch to the pulse generator to perform the next pulsed electric field ablation operation, or display information indicating the stop of the pulsed electric field ablation operation according to the judgment result.

[0076] As Figure 2 , Figure 7 shown, before pulsed electric field treatment, impedance spectrum measurement is performed on the target area of the patient. As Figure 3 , Figure 7 shown, after pulsed electric field treatment, when the set working time of the timer reaches the set value, impedance spectrum measurement of the patient's target area starts. Specifically, after pulsed electric field treatment, without changing the catheter position, when the timer shows five minutes, the impedance spectrum after treatment is collected through the ablation catheter, and the impedance spectrum data after treatment is input into the ablation depth processing unit. The impedance measurement module is connected to the ablation depth processing unit through a wire. The ablation depth processing unit extracts impedance indicators by calling the built-in analysis model according to the impedance data measured before and after pulsed electric field treatment, Figure 4 as shown, Figure 5 as shown. Figure 4Shows an example of the measured impedance spectrum and the fitted impedance spectrum. According to Control Figure 6 The quantitative curve of the ablation depth evaluated according to the impedance is used to evaluate the ablation depth at this time. The ablation depth processing unit outputs the evaluated ablation depth result and sends it to the ablation depth display module to display the ablation depth in a three-dimensional effect. Doctors can intuitively observe the ablation effect through the ablation depth display module. The ablation depth display module is connected to the switch switching module. When the displayed ablation depth result is not sufficient for trans-wall ablation of the cardiac target area, the switch switching module will switch to the pulse generator according to the received signal for the next pulsed electric field ablation. When the ablation depth can reach trans-wall ablation of the target area, the interface of the ablation depth display module will turn on a red light to indicate that the treatment is completed.

[0077] Furthermore, the measurement frequency of the impedance measurement module includes components from 100 Hz to 1 MHz, the measured peak-to-peak AC voltage is not greater than 5 V. For example, the measured peak-to-peak AC voltage is 200 mV, the number of sampling points is not less than 8 and is distributed in the measurement frequency range in a log function. For example, the number of sampling points is set to 201, and it takes about 17 seconds to complete one impedance spectrum data measurement and acquisition. The initial broadband impedance spectrum before treatment is collected through the ablation catheter, and the initial broadband impedance spectrum data is input into the ablation depth processing unit. Figure 2 、 3 The shape of the ablation catheter shown in

[0078] is just an example. In the actual device, ablation catheters of different shapes can be selected according to clinical needs.

[0079] It should be noted that before pulsed electric field treatment, the impedance spectrum measurement can be switched to the impedance measurement module by the doctor himself. At this time, the timer does not work, and the doctor collects the impedance spectrum before pulsed electric field treatment. After completing this step, the rest of the steps are controlled by signals. The switch switching module will switch to the pulse processing path according to the received signal. In addition, after completing this step, the timer starts timing for 5 minutes, and the switch switches to the impedance measurement path for impedance spectrum measurement after pulsed electric field treatment.

[0079] The input of the ablation depth processing unit is the broadband impedance spectra measured before and after pulsed electric field treatment, and the output is the ablation depth. Furthermore, the ablation depth processing unit performs Cole-Cole model fitting based on the broadband impedance spectrum, and the fitting formula is:

[0080] ;

[0081] The indexes and in the models before and after pulse treatment are respectively extracted through fitting for calculating the impedance index , The calculation formula of

[0082] 。

[0083] Then, confirm the corresponding ablation depth from the ablation depth quantitative curve and output this depth to the ablation depth display module.

[0084] Figure 6 Fig. shows an example of the quantitative curve for evaluating the ablation depth by impedance. In this embodiment, the ablation depth quantitative curve is built into the ablation depth processing unit, which is used to find the corresponding ablation depth according to the analyzed and calculated . The ablation depth quantitative curve is included in a database, which is placed in the depth processing unit module. Select the corresponding depth quantitative curve according to the cardiac ablation catheter used, so as to output the ablation depth.

[0085] This device can evaluate the ablation depth in situ and in real time during the operation based on the PFA catheter, and judge the surgical process. And the operation process of this device is simple. Doctors can directly observe the ablation effect through the display module, which is convenient for adjusting the treatment parameters in real time. Embodiment 2

[0086] A method for evaluating the ablation depth of pulsed electric field cardiac ablation is based on the pulsed electric field cardiac ablation depth evaluation device provided in Embodiment 1. For the detailed description of the device, reference can be made to the corresponding description in the above device embodiment, which will not be elaborated here. This method is used to evaluate the ablation depth of pulsed electric field ablation (PFA), and can evaluate the ablation depth of PFA cardiac ablation during the operation. As Figure 1 、 Figures 7 - 8 shown, this method includes the following steps:

[0087] S100. Obtain the impedance spectrum of the target area of the patient's heart before pulsed electric field treatment, denoted as the initial broadband impedance spectrum;

[0088] As Figure 2 shown, before pulsed electric field treatment, measure the impedance spectrum of the target area of the patient.

[0089] In some embodiments, before pulsed electric field treatment, the impedance spectrum measurement can be switched to the impedance measurement module by the doctor himself. At this time, the timer does not work, and the doctor collects the impedance spectrum before pulsed electric field treatment. After completing this step, the remaining steps are all controlled by signals. The switch switching module will switch to the pulse processing path according to the received signal. In addition, after completing this step, the timer starts timing for 5 minutes, and the switch switches to the impedance measurement path to measure the impedance spectrum after pulsed electric field treatment.

[0090] ​Specifically, the switch switching module is used to quickly switch between pulsed electric field treatment and impedance measurement. When the switch is switched to the pulse generator, pulsed electric field cardiac ablation can be performed on the patient. When the switch is switched to the impedance measurement module, impedance spectroscopy measurement can be performed on the ablation area of the patient.

[0091] S110. Obtain the impedance spectrum of the target area of the patient's heart after pulsed electric field treatment, denoted as the post-pulse broadband impedance spectrum;

[0092] As Figure 3 shown, after pulsed electric field treatment, when the set working time of the timer reaches the set value, start measuring the impedance spectrum of the target area of the patient. Specifically, after pulsed electric field treatment, without changing the position of the catheter, when the timer shows five minutes, collect the impedance spectrum after treatment through the ablation catheter, and input the impedance spectrum data after treatment into the ablation depth processing unit.

[0093] In this embodiment, the measurement frequency of the impedance measurement module includes components from 100 Hz to 1 MHz, the peak-to-peak value of the measured AC voltage is not greater than 5 V. For example, the peak-to-peak value of the measured AC voltage is 200 mV, the number of sampling points is not less than 8 and is distributed in the measurement frequency range in a log function. For example, the number of sampling points is set to 201, and it takes about 17 seconds to complete one impedance spectrum data measurement and acquisition. Collect the initial broadband impedance spectrum before treatment through the ablation catheter, and input the initial broadband impedance spectrum data into the ablation depth processing unit. Figure 2 、 3 The shape of the ablation catheter shown in

[0094] is only an example. In the actual device, ablation catheters with different shapes can be selected according to clinical needs.

[0095] Further, as Figure 9 shown, the step of inputting the initial broadband impedance spectrum and the post-pulse broadband impedance spectrum into the evaluation model to obtain the ablation depth evaluation result includes:

[0096] S121. Perform Cole-Cole model fitting based on the broadband impedance spectrum, and the fitting formula is:

[0097] ;

[0098] S122. Respectively extract the indexes and in the models before and after pulse treatment through fitting for calculating the impedance index , The calculation formula of

[0099] ;

[0100] Specifically, the ablation depth processing unit extracts impedance metrics by calling a built-in analysis model based on the impedance data measured before and after pulsed electric field treatment, as Figure 4 shown, to extract impedance metrics. such as Figure 5 shown. Figure 4 An example of the measured impedance spectrum and the fitted impedance spectrum is shown.

[0101] S123. Confirm the corresponding ablation depth from the ablation depth quantification curve and output the ablation depth. Specifically, the ablation depth is evaluated at this time according to the ablation depth quantification curve for impedance evaluation.

[0102] Specifically, according to the control Figure 6 the ablation depth is evaluated at this time according to the ablation depth quantification curve for impedance evaluation.

[0103] Figure 6 An example of the ablation depth quantification curve for impedance evaluation is shown. In this embodiment, the ablation depth quantification curve is built into the ablation depth processing unit, and its function is to find the corresponding ablation depth based on the analysis and calculation. The ablation depth quantification curve is included in a database, and the database is placed within the depth processing unit module. The corresponding depth quantification curve is selected according to the cardiac ablation catheter used, and thus the ablation depth is output.

[0104] S130. Display the ablation depth result in the current three-dimensional model of tissue ablation depth;

[0105] Specifically, the ablation depth processing unit outputs the evaluated ablation depth result and sends it to the ablation depth display module to display the ablation depth in a three-dimensional effect. The doctor can intuitively observe the ablation effect through the ablation depth display module.

[0106] S140. Determine whether the ablation depth result reaches transmurality to determine whether to stop performing the pulsed electric field ablation operation.

[0107] Furthermore, as Figure 10 shown, the step of determining whether the ablation depth result reaches transmurality to determine whether to stop performing the pulsed electric field ablation operation includes:

[0108] S141. When the ablation depth does not reach transmurality ablation of the cardiac target area, control the execution of the next pulsed electric field ablation operation;

[0109] Specifically, when the displayed ablation depth result is not sufficient for transmurality ablation of the cardiac target area, the switch switching module will switch to the pulse generator according to the received signal for the next pulsed electric field ablation.

[0110] S142. When the ablation depth reaches transmural ablation of the cardiac target area, stop performing the pulsed electric field ablation operation.

[0111] Specifically, when the ablation depth can reach transmural ablation of the target area, a red light will be lit on the interface of the ablation depth display module to indicate the completion of the treatment.

[0112] This method can evaluate the ablation depth in situ and in real time during the operation based on the PFA catheter, and judge the progress of the operation. And the operation process of this method is simple. Doctors can directly observe the ablation effect through the displayed content, which is convenient for real-time adjustment of treatment parameters. Embodiment 3

[0113] A computer device 200, as Figure 11 shown, includes a memory 210, a processor 220, and a computer program 230 stored on the memory and executable on the processor. When the processor executes the computer program, it implements the steps of a method for evaluating the ablation depth of pulsed electric field ablation of the heart. For a detailed description of the method, reference can be made to the corresponding description in the above method embodiments, which will not be elaborated here. Embodiment 4

[0114] A computer-readable storage medium, as Figure 12 shown, stores a computer program thereon. When the computer program is executed by a processor, it implements the steps of a method for evaluating the ablation depth of pulsed electric field ablation of the heart. For a detailed description of the method, reference can be made to the corresponding description in the above method embodiments, which will not be elaborated here.

[0115] The number of devices and the scale of processing described here are used to simplify the description of the present invention. The applications, modifications, and variations of the present invention are obvious to those skilled in the art.

[0116] Although the embodiments of the present invention have been disclosed above, they are not limited to the applications listed in the specification and embodiments. It can be fully applied to various fields suitable for the present invention. For those skilled in the art, additional modifications can be easily made. Therefore, without departing from the general concept defined by the claims and their equivalents, the present invention is not limited to the specific details and the illustrated examples here.

[0117] The device, computer device, non-volatile computer storage medium provided in the embodiments of this specification correspond to the method. Therefore, the device, computer device, and non-volatile computer storage medium also have beneficial technical effects similar to the corresponding method. Since the beneficial technical effects of the method have been described in detail above, the beneficial technical effects of the corresponding device, computer device, and non-volatile computer storage medium will not be elaborated here.

[0118] Those skilled in the art also know that, in addition to implementing the controller in the form of pure computer-readable program code, it is entirely possible to implement the same function by logically programming method steps so that the controller is implemented in the form of logic gates, switches, application-specific integrated circuits, programmable logic controllers, embedded microcontrollers, etc. Therefore, such a controller can be regarded as a hardware component, and the devices included therein for implementing various functions can also be regarded as the structures within the hardware component. Or even, the devices for implementing various functions can be regarded as either software units for implementing the method or structures within the hardware component.

[0119] The systems, devices, or units illustrated in the above embodiments can be specifically implemented by computer chips or entities, or by products with certain functions. For the convenience of description, when describing the above devices, they are described as various units according to their functions. Of course, when implementing one or more embodiments of this specification, the functions of each unit can be implemented in the same or multiple software and / or hardware.

[0120] Those skilled in the art should understand that the embodiments of this specification can be provided as methods, systems, or computer program products. Therefore, the embodiments of this specification can take the form of completely hardware embodiments, completely software embodiments, or embodiments combining software and hardware aspects. Moreover, the embodiments of this specification can take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk memories, CD-ROMs, optical memories, etc.) containing computer-usable program code.

[0121] This specification is described with reference to the flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to the embodiments of this specification. It should be understood that each flow and / or block in the flowchart and / or block diagram, and the combination of flows and / or blocks in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to the processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing devices to generate a machine, such that the instructions executed by the processor of the computer or other programmable data processing devices generate a device for implementing the functions specified in Figure 1 one flow or multiple flows and / or blocks Figure 1 one block or multiple blocks.

[0122] These computer program instructions can also be stored in a computer-readable memory that can direct a computer or other programmable data processing device to work in a specific manner, such that the instructions stored in the computer-readable memory generate a manufactured article including an instruction device, and the instruction device implements the functions specified in Figure 1 one flow or multiple flows and / or blocks Figure 1 one block or multiple blocks.

[0123] These computer program instructions can also be loaded onto a computer or other programmable data processing device, so that a series of operation steps are executed on the computer or other programmable device to generate a computer-implemented process. Thus, the instructions executed on the computer or other programmable device provide steps for implementing the functions specified in one process or multiple processes and / or one block or multiple blocks. Figure 1 one process or multiple processes and / or blocks Figure 1 or steps for implementing the functions specified in one block or multiple blocks.

[0124] It should also be noted that the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, commodity or device comprising a series of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, commodity or device. Without further limitation, an element defined by the statement "comprising one..." does not exclude the presence of additional identical elements in the process, method, commodity or device comprising the said element.

[0125] This specification can be described in the general context of computer-executable instructions executed by a computer, such as program units. Generally, program units include routines, programs, objects, components, data structures, etc. that perform specific tasks or implement specific abstract data types. The specification can also be practiced in a distributed computing environment where tasks are performed by remote processing devices connected through a communication network. In a distributed computing environment, program units can be located in local and remote computer storage media including storage devices.

[0126] Each embodiment in this specification is described in a progressive manner. For the same or similar parts among the embodiments, reference can be made to each other. Each embodiment focuses on the differences from other embodiments. In particular, for system embodiments, since they are basically similar to method embodiments, they are described relatively simply, and reference can be made to the relevant parts of the method embodiments for the related content.

[0127] The above is only for the embodiments of this specification and is not used to limit one or more embodiments of this specification. For those skilled in the art, there can be various changes and modifications to one or more embodiments of this specification. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of one or more embodiments of this specification shall be included within the scope of the claims of one or more embodiments of this specification.

Claims

1. A pulsed electric field cardiac ablation depth evaluation device, characterized in that: It includes a switch switching module, a timer, an impedance measurement module, an ablation depth processing unit, and an ablation depth display module; among them, The switch switching module is used to switch between the pulse generator and the impedance measurement module; The impedance measurement module is used to perform impedance spectrum measurement on the target area of the patient's heart; The timer is used to control the measurement time of the impedance measurement module; The ablation depth processing unit is used to extract impedance indicators by calling an evaluation model based on the impedance spectra measured before and after pulsed electric field treatment, confirm the ablation depth corresponding to the impedance indicators from the ablation depth quantitative curve, and output it to the ablation depth display module; The ablation depth display module is used to display the ablation depth in the current three-dimensional model of tissue ablation depth, and determine whether the ablation depth result reaches transmyocardial penetration. According to the judgment result, a signal is sent to the switch switching module to cause the switch switching module to switch to the pulse generator to perform the next pulsed electric field ablation operation, or display information indicating the stop of the pulsed electric field ablation operation according to the judgment result; The ablation depth processing unit performs Cole-Cole model fitting based on the broadband impedance spectrum, and the fitting formula is: ； Extract the indicators in the model before and after pulsed treatment by fitting and for calculating the impedance indicator , The calculation formula is as follows: 。 2. The pulse electric field cardiac ablation depth evaluation device according to claim 1, wherein: The measurement frequency of the impedance measurement module includes components from 100 Hz to 1 MHz, the peak-to-peak value of the measured AC voltage is not greater than 5 V, the number of sampling points is not less than 8, and they are distributed in the measurement frequency range in a logarithmic function.

3. The pulsed electric field cardiac ablation depth assessment device according to claim 1, wherein: The ablation depth quantitative curve is pre-stored in a database, and the database is placed in the ablation depth processing unit.

4. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the computer program is executed by a processor, it implements a method for evaluating the ablation depth of pulsed electric field ablation of the heart, and this method includes the following steps: Obtain the impedance spectrum of the target area of the patient's heart before pulsed electric field treatment, denoted as the initial broadband impedance spectrum; Obtain the impedance spectrum of the target area of the patient's heart after pulsed electric field treatment, denoted as the post-pulse broadband impedance spectrum; Input the initial broadband impedance spectrum and the post-pulse broadband impedance spectrum into the evaluation model to obtain the ablation depth evaluation result; Display the ablation depth result in the current three-dimensional model of tissue ablation depth; Determine whether the ablation depth result reaches transmyocardial penetration to determine the stop of the pulsed electric field ablation operation; The step of inputting the initial broadband impedance spectrum and the post-pulse broadband impedance spectrum into the evaluation model to obtain the ablation depth evaluation result includes: Perform Cole-Cole model fitting based on the broadband impedance spectrum, and the fitting formula is: ； Extract the indicators in the model before and after pulsed treatment by fitting and for calculating the impedance indicator , The calculation formula is: ； Confirm the ablation depth corresponding to it from the ablation depth quantification curve and output the ablation depth.

5. A computer-readable storage medium according to claim 4, characterized in that, The ablation depth quantitative curve is pre-stored in a database.

6. A computer-readable storage medium according to claim 4, wherein The step of determining whether the ablation depth result reaches transmyocardial penetration to determine the stop of the pulsed electric field ablation operation includes: When the ablation depth does not reach transmyocardial ablation of the target area of the heart, control the execution of the next pulsed electric field ablation operation; When the ablation depth reaches transmyocardial ablation of the target area of the heart, stop the execution of the pulsed electric field ablation operation.

7. A computer device, comprising a memory and a processor, wherein the memory comprises the computer-readable storage medium according to any one of claims 4 to 6, characterized in that, When the processor executes the computer program in the memory, it implements the method for evaluating the ablation depth of pulsed electric field ablation of the heart.

Images