Impedance-based Energy Control Method, System, and Pulsed Electric Field Ablation System

By measuring the impedance of the pulse ablation catheter and calculating the ablation parameters, controlling the energy output, the problems of poor attachment, overheating, and bubbles in pulsed electric field ablation technology are solved, and the treatment effect is improved.

CN115414110BActive Publication Date: 2025-07-25JIANHU MEDICAL TECH (SUZHOU) CO LTD
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Patent Information

Application Number
CN202211102014.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-09-09
Publication Date
2025-07-25
Estimated Expiration
2042-09-09

AI Technical Summary

Technical Problem

In cardiac treatment, the existing pulse electric field ablation technology has poor attachment to the ablation catheter, excessive calories, microbubbles and other adverse conditions, resulting in poor treatment effect.

Method used

By measuring the impedance between adjacent pulse electrodes of the pulse ablation catheter, calculating the integrated ablation parameters, controlling the energy output power or pulse width length of the pulse electrode to ensure good fit and avoid overheating and bubble problems.

Benefits of technology

It significantly improves the therapeutic effect of cardiac electrophysiological pulse ablation, ensures good fit between the catheter and the target tissue, while avoiding overheating and microbubble generation, and does not require additional structure and equipment based on existing treatment plans.

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Abstract

The present invention discloses an impedance-based energy control method, system, and pulsed electric field ablation system, which are applicable to a pulsed ablation catheter and include: measuring the impedance between adjacent pulse electrodes among the respective pulse electrodes of the pulsed ablation catheter; calculating a comprehensive ablation parameter based on the impedance and controlling the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameter. Also disclosed is a pulsed electric field ablation system, including: a pulsed ablation catheter and a pulsed ablation mainframe, the pulsed ablation mainframe being electrically connected to the pulsed ablation catheter; a plurality of pulse electrodes are provided on the pulsed ablation catheter, and the pulsed ablation mainframe controls the pulse power of the pulse electrodes by using the impedance-based energy control method described above. The present invention can significantly improve the treatment effect of cardiac electrophysiological pulsed ablation based on the existing conventional treatment scheme.
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Description

Technical Field

[0001] The present invention relates to the field of pulse control, and particularly to an impedance-based energy control method, system, and pulsed electric field ablation system. Background Art

[0002] In the clinical applications of modern medicine, cardiac electrophysiology is an important branch. Cardiac electrophysiology refers to the bioelectric phenomena of myocardial cells, which form the basis for the principles of electrocardiogram and the pathogenesis of arrhythmias. There is a potential difference across the myocardial cell membrane. When the myocardial cell is excited, it will cause changes in the potential difference across the cell membrane. At rest, the inside of the myocardial cell membrane contains sodium ions, and the outside contains potassium ions and chloride ions. When the myocardial cell is excited, a potential difference will be generated, resulting in the inward flow of potassium and the outward flow of sodium, causing depolarization of the myocardial cell and contraction. Conversely, when the myocardial cell repolarizes, sodium ions flow inward and potassium ions flow outward. Therefore, when the electrical activity of myocardial cells is abnormal, arrhythmias will occur.

[0003] Arrhythmia (atrial fibrillation) refers to an abnormal phenomenon in which the heart rhythm and heart rate change, mainly caused by changes in the generation or conduction of electrical activity in the myocardium. In a healthy heart, the sinoatrial node acts as the heart pacemaker, generating electrical pulses that are then conducted through the atria to the ventricles, thus called "sinus rhythm". The sinoatrial node, atrioventricular node, atrioventricular bundle, and Purkinje fibers act as the network for cardiac current conduction, stimulating the heart to beat and maintaining the normal operation of the human blood system. When the pacemaker cells in the sinoatrial node spontaneously generate electrical pulses that cause depolarization, or when the pulse conduction of action potentials at sites outside the sinoatrial node changes, atrial fibrillation will occur. Currently, ablation surgery is the main means of treating atrial fibrillation. A catheter is inserted into the heart through the groin or neck area, and the electrodes at the tip of the catheter are used to detect the electrophysiological characteristics of the heart, and the location where the electrical signal is abnormal is the area to be ablated. Once the precise location is determined, the doctor can deliver energy through the catheter to perform local ablation, restoring the heart rhythm to the normal level. The current ablation techniques are divided into radiofrequency ablation, cryoablation, and cardiac pulsed electric field ablation.

[0004] With the gradual in-depth research, the pulsed electric field ablation (also known as irreversible electroporation ablation) technology has been clinically proven to have superior tissue selectivity. Especially in the field of atrial fibrillation ablation, it overcomes the defects of a series of complications caused by the non-selective ablation of diseased myocardium and normal tissues by traditional radiofrequency and cryoablation therapies. However, the precise application of this technology is currently in the hands of foreign companies, and they are at the forefront of the market. In the Chinese market, companies such as Medtronic, Johnson & Johnson, and Farapulse have taken the lead in conducting clinical trials of atrial fibrillation ablation based on pulsed electric fields. Domestic companies such as Jinjiang, Nuomao, Yingtelikang, and Huitai have also followed suit and carried out the research and development and clinical trials of domestic pulsed electric field ablation systems.

[0005] The clinical superiority demonstrated by pulsed electric field ablation technology has greatly promoted the progress of cardiac electrophysiology therapy. However, with the release of more clinical data and results, it shows that there are still many clinical challenges to be solved in current pulsed electric field ablation systems, such as how to ensure the apposition of the ablation catheter to the target tissue during treatment, how to ensure the transmurality of pulsed ablation, how to achieve a perfect atrial fibrillation ablation effect, and how to suppress excessive heat, microbubbles, high-voltage arcs, thrombus, and muscle spasms generated during ablation.

[0006] Multiple studies have shown that apposition has a huge impact on the final achieved effect. To achieve good apposition between the pulsed ablation electrode and the target tissue, different companies have designed various solutions. The balloon ablation electrode designed by Medtronic directly attaches all ablation electrodes to the target tissue by inflating the balloon at the tip of the electrode to achieve good apposition to the tissue and improve the quality effect. This method very cleverly solves the apposition problem and the treatment effect is also improved. The disadvantage is that the complexity of the catheter process increases, the manufacturing process and verification process are complex, and the balloon filler is also required. To reduce adverse conditions such as excessive heat and microbubbles, Johnson & Johnson invented the perfusion water catheter technology to directly inject normal saline into the catheter to reduce heat and inhibit the generation of microbubbles, but it cannot solve the apposition problem well. Summary of the Invention

[0007] To solve the problem of poor ablation effect caused by inconvenient surface apposition in the prior art, the present invention provides an impedance-based energy control method, system, and pulsed electric field ablation system.

[0008] On the one hand, an impedance-based energy control method applicable to a pulsed ablation catheter is provided, including:

[0009] Measuring the impedance between adjacent pulse electrodes in each pulse electrode of the pulsed ablation catheter;

[0010] Calculating a comprehensive ablation parameter according to the impedance and controlling the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameter.

[0011] Preferably, the calculating a comprehensive ablation parameter according to the impedance and controlling the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameter specifically includes:

[0012] When the impedance of the pulse electrode is less than the first threshold, according to the formula W i =Se i W0, formula L i =C i3 、formula Se i =q1Z i +q2L iCalculate the pulse energy output power or pulse width length;

[0013] Wherein, i represents different pulse electrodes; Wi represents the power or pulse width length output by the pulse electrode i; W0 represents the lowest effective energy output when the pulse electrode is in good contact; Se i represents the comprehensive ablation parameter of the pulse electrode i; Z i represents the impedance of the electrode i; L i represents the distance between the electrode i and the target tissue; C i1 represents the constant term of the corresponding calculation formula under the impedance range.

[0014] Further preferably, the step of calculating the comprehensive ablation parameter according to the impedance and controlling the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameter specifically further includes:

[0015] When the impedance of the pulse electrode is greater than the first threshold but less than the second threshold, according to the formula W i =Se i W0, formula Formula Se i =q1Z i +q2L i Calculate the pulse energy output power or pulse width length;

[0016] Wherein, C i2 、C i3 represent the constant terms of the corresponding calculation formulas under the impedance range; k2, k3 represent the parameters of the corresponding calculation formulas under different impedance ranges.

[0017] Further preferably, the step of calculating the comprehensive ablation parameter according to the impedance and controlling the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameter specifically further includes:

[0018] When the impedance of the pulse electrode is greater than the second threshold, according to the formula W i =Se i W0, formula L i =C i1 +k1Z i 、Formula Se i =q1Z i +q2L i Calculate the pulse energy output power or pulse width length;

[0019] Wherein, k1 represents the parameter of the corresponding calculation formula under different impedance ranges.

[0020] On the other hand, there is provided an impedance-based energy control system applicable to a pulsed ablation catheter, including:

[0021] An impedance measurement module for measuring the impedance between adjacent pulse electrodes among the respective pulse electrodes of the pulsed ablation catheter;

[0022] A power calculation and control module for calculating comprehensive ablation parameters based on the impedance and controlling the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameters.

[0023] Preferably, the power calculation and control module specifically includes:

[0024] When the impedance of the pulse electrode is less than a first threshold, according to the formula W i = Se i W0, the formula L i = C i3 The formula Se i = q1Z i + q2L i Calculate the pulse energy output power or pulse width length;

[0025] Wherein, i represents different pulse electrodes; Wi represents the power or pulse width length output by the pulse electrode i; W0 represents the lowest effective energy output when the pulse electrode is in good contact; Se i Represents the comprehensive ablation parameter of the pulse electrode i; Z i Represents the impedance of the electrode i; L i Represents the distance of the electrode i from the target tissue; C i1 Represents the constant term of the corresponding calculation formula in the impedance range.

[0026] Further preferably, the power calculation and control module specifically further includes:

[0027] When the impedance of the pulse electrode is greater than the first threshold but less than a second threshold, according to the formula W i = Se i W0, the formula The formula Se i = q1Z i + q2L i Calculate the pulse energy output power or pulse width length;

[0028] Wherein, C i2 、C i3 Represents the constant term of the corresponding calculation formula in the impedance range; k2, k3 represent the parameters of the corresponding calculation formula in different impedance ranges.

[0029] Further preferably, the power calculation and control module specifically further includes:

[0030] When the impedance of the pulse electrode is greater than the second threshold, according to the formula W i = Se i W0, formula L i = C i1 + k1Z i 、formula Se i = q1Z i + q2L i calculate the pulse energy output power or pulse width length of the pulse;

[0031] wherein, k1 represents the parameter of the corresponding calculation formula in different impedance ranges.

[0032] On the other hand, a pulsed electric field ablation system is provided, including: a pulsed ablation catheter and a pulsed ablation host, and the pulsed ablation host is electrically connected to the pulsed ablation catheter;

[0033] A plurality of pulse electrodes are arranged on the pulsed ablation catheter, and the pulsed ablation host uses the above-mentioned impedance-based energy control method to control the pulse power of the pulse electrodes.

[0034] Preferably, when and only when the pulsed ablation catheter is abutted against the target tissue, the pulsed ablation host measures the impedance between adjacent pulse electrodes among the pulse electrodes of the pulsed ablation catheter, calculates the comprehensive ablation parameters according to the impedance, and controls the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameters.

[0035] The present invention comprehensively considers the problems of abutment, excessive heat, microbubbles, etc. in pulsed electric field ablation, solves the problem of poor disease treatment effect caused by poor abutment between the pulsed field ablation catheter and the target tissue. At the same time, it avoids the problems of overheating and bubble generation that are likely to occur when too much energy is output to ensure the treatment effect on the target tissue. On the other hand, different from the existing balloon solutions for abutment states, etc., no additional structures and devices are required, and the treatment effect of cardiac electrophysiological pulsed ablation can be significantly improved based on the existing conventional treatment schemes. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for description in the embodiments. Obviously, the following drawings are only some embodiments of the present invention, and those of ordinary skill in the art can also obtain other drawings without creative efforts based on these drawings.

[0037] Figure 1 It is a schematic flow chart of Embodiment 1 of the present invention;

[0038] Figure 2Schematic flowchart of Embodiment 2 of the present invention;

[0039] Figure 3 Schematic structural diagram of Embodiment 5 of the present invention;

[0040] Figure 4 Ablation effect of ex vivo tissue without the intelligent adjustment algorithm of the present invention;

[0041] Figure 5 Ablation effect of ex vivo tissue with the intelligent output energy adjustment algorithm of the present invention. Detailed implementation manners

[0042] In the following description, specific details such as specific system architectures and technologies are presented for the purpose of illustration rather than limitation, so as to thoroughly understand the embodiments of the present application. However, those skilled in the art should clearly understand that the present application can also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to avoid unnecessary details from interfering with the description of the present application.

[0043] It should be understood that when used in this specification and the appended claims, the term "comprising" indicates the presence of the described features, wholes, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, components, and / or combinations thereof.

[0044] For the sake of simplicity of the drawings, only the parts related to the present invention are schematically shown in each figure, and they do not represent the actual structure of the product. Additionally, for the sake of simplicity and easy understanding of the drawings, in some figures, for components with the same structure or function, only one of them is schematically drawn, or only one of them is labeled. In this document, "one" not only means "only this one", but also means the situation of "more than one".

[0045] It should be further understood that the term "and / or" used in the specification and appended claims of the present application refers to any combination and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0046] In addition, in the description of the present application, terms such as "first" and "second" are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0047] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will describe the specific embodiments of the present invention with reference to the accompanying drawings. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings, and other embodiments can also be obtained.

[0048] Embodiment 1:

[0049] As Figure 1 shown, this embodiment provides an impedance-based energy control method applicable to a pulsed ablation catheter, including:

[0050] S1: Measure the impedance between adjacent pulse electrodes in each pulse electrode of the pulsed ablation catheter;

[0051] S2: Calculate the comprehensive ablation parameters according to the impedance and control the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameters. At the same time, in the specific power control, the power can be directly adjusted, or the voltage can be adjusted according to actual needs to adjust the power.

[0052] During the process of pulsed radiofrequency ablation, common ablation catheters include annular electrode catheters and rod-shaped ablation catheters, and the number of electrodes distributed on the catheter ranges from 4 to 10 electrodes. During treatment, high-voltage pulses are released between adjacent and spaced electrodes to achieve the treatment of the target tissue. Through clinical research and experimental verification, it is very difficult to achieve good apposition of all electrodes during the treatment process, especially for multi-electrode ablation catheters, and it cannot ensure good apposition of all electrodes and the target tissue.

[0053] Therefore, in this embodiment, by measuring the resistance of the catheter electrodes in the heart, the apposition state of the catheter is distinguished from the measurement difference of the resistance. When the catheter apposition is not good, ablation treatment is not performed, thereby improving the catheter ablation effect. In the specific use process, on the one hand, the ablation effect can be adjusted by adjusting the power, and on the other hand, according to actual needs, the ablation effect can also be adjusted by adjusting means such as the pulse width length.

[0054] This embodiment comprehensively considers the apposition problem, excessive heat, microbubbles and other adverse conditions in pulsed electric field ablation, and solves the problem of poor disease treatment effect caused by poor apposition between the pulsed field ablation catheter and the target tissue. At the same time, it avoids the problems of overheating and bubbles that are likely to occur when too much energy output is used to ensure the treatment effect on the target tissue. On the other hand, different from the existing balloon solutions for apposition states, etc., no additional structures and equipment are required, and the cardiac electrophysiological pulsed ablation treatment effect can be significantly improved based on the existing conventional treatment schemes.

[0055] This embodiment is described with reference to Figure 4 and Figure 5 . The tissue used in the experiment is ex vivo potato tissue. Pulsed ablation is performed at the same position, and the experimental electrode is a 10-electrode annular electrode. Figure 4 After the same energy is output from each electrode, a staining solution is selected for staining. After staining, 10 small petals can be observed, which is the position where the annular electrode is placed. After the electrode emits pulsed energy, it will cause irreversible electroporation damage to the potato tissue. The size of the stained area represents the size of the ablation area. Figure 5 For the experiment under the sampling energy output adjustment algorithm, it can be clearly observed that the ablation area becomes larger, and the ablation consistency of each electrode is very good.

[0056] Embodiment 2:

[0057] As Figure 2 shown, this embodiment provides an impedance-based energy control method applicable to a pulsed ablation catheter, including:

[0058] S1: Measure the impedance between adjacent pulsed electrodes in each pulsed electrode of the pulsed ablation catheter;

[0059] S2-1: When the impedance of the pulsed electrode is less than the first threshold, calculate the pulsed energy output power or pulse width length according to the first set of formulas, namely formula W i =Se i W0, formula L i =C i3 , formula Se i =q1Z i +q2L i ;

[0060] S2-2: When the impedance of the pulsed electrode is greater than the first threshold but less than the second threshold, calculate the pulsed energy output power or pulse width length according to the second set of formulas, namely formula W i =Se i W0, formula formula Se i =q1Z i +q2L i ;

[0061] S2-3: When the impedance of the pulsed electrode is greater than the second threshold, calculate the pulsed energy output power or pulse width length according to the third set of formulas, namely formula W i =Se i W0, formula L i =C i1 +k1Z i , formula Se i =q1Z i +q2L i ;

[0062] Among them, i represents different pulsed electrodes; Wi represents the power or pulse width length output by the pulsed electrode i; W0 represents the lowest effective energy output when the pulsed electrode is in good contact; Se i represents the comprehensive ablation parameter of the pulsed electrode i; Z i represents the impedance of the electrode i; L i represents the distance between the electrode i and the target tissue; C i1 represents the constant term of the corresponding calculation formula under the impedance range. C i2 、C i3 represents the constant term of the corresponding calculation formula under the impedance range; k2 and k3 represent the parameters of the corresponding calculation formula under different impedance ranges. k1 represents the parameters of the corresponding calculation formula under different impedance ranges.

[0063] Example 3:

[0064] This embodiment provides an impedance-based energy control system applicable to a pulsed ablation catheter, including:

[0065] An impedance measurement module for measuring the impedance between adjacent pulsed electrodes among the pulsed electrodes of the pulsed ablation catheter;

[0066] A power calculation and control module for calculating the comprehensive ablation parameter according to the impedance and controlling the pulsed energy output power or pulse width length of each pulsed electrode pair according to the comprehensive ablation parameter. At the same time, in the specific control of the power, the power can be directly adjusted, or the voltage can be adjusted according to actual needs to adjust the power.

[0067] During the process of pulsed radiofrequency ablation, common ablation catheters include annular electrode catheters and rod-shaped ablation catheters, and the number of electrodes distributed on the catheter ranges from 4 to 10. During treatment, high-voltage pulses are released between adjacent and spaced electrodes to achieve the treatment of the target tissue. Through clinical research and experimental verification, it is difficult to achieve good contact of all electrodes during the treatment process, especially for multi-electrode ablation catheters, and it cannot ensure good contact between all electrodes and the target tissue.

[0068] Therefore, in this embodiment, by measuring the resistance of the catheter electrode in the heart, the contact state of the catheter is distinguished from the measurement difference of the resistance. When the catheter is not in good contact, ablation treatment is not performed, thereby improving the ablation effect of the catheter.

[0069] This embodiment comprehensively considers the problems of apposition in pulsed electric field ablation, excessive heat, microbubbles and other adverse conditions, and solves the problem of poor treatment effect of diseases caused by poor apposition between the pulsed field ablation catheter and the target tissue. At the same time, it avoids the problems of overheating and bubble generation that are prone to occur when a large energy output is used to ensure the treatment effect on the target tissue. On the other hand, different from the existing balloon solutions for solving the apposition state and other schemes, the design of the present invention does not require additional structures and equipment, and can significantly improve the treatment effect of cardiac electrophysiological pulsed ablation based on the existing conventional treatment schemes.

[0070] This embodiment is shown in Figure 4 and Figure 5 , the test tissue is ex vivo potato tissue, pulsed ablation is performed at the same position, and the test electrode is a 10-electrode annular electrode. Figure 4 After the same energy is output from each electrode, a staining solution is selected for staining. After staining, 10 small petals can be observed, which is the position where the annular electrode is placed. After the electrode emits pulsed energy, it will cause irreversible electroporation to damage the potato tissue. The size of the stained area represents the size of the ablation area. Figure 5 For the test under the sampling energy output adjustment algorithm, it can be clearly observed that the ablation area becomes larger and the ablation consistency of each electrode is very good.

[0071] Example 4:

[0072] This embodiment provides an impedance-based energy control system applicable to a pulsed ablation catheter, including: The power calculation and control module specifically includes:

[0073] When the impedance of the pulsed electrode is less than the first threshold, according to the formula W i =Se i W0, formula L i =C i3 , formula Se i =q1Z i +q2L i calculate the pulsed energy output power or pulse width length; when the impedance of the pulsed electrode is greater than the second threshold, according to the formula W i =Se i W0, formula L i =C i1 +k1Z i , formula Se i =q1Z i +q2L i calculate the pulsed energy output power or pulse width length; when the impedance of the pulsed electrode is greater than the first threshold but less than the second threshold, according to the formula W i =Se i W0, formula formula Sei = q1Z i + q2L i Calculate the pulse energy output power or pulse width length;

[0074] Wherein, i represents different pulse electrodes; Wi represents the power or pulse width length output by the pulse electrode i; W0 represents the lowest effective energy output when the pulse electrode is in good contact; Se i represents the comprehensive ablation parameter of the pulse electrode i; Z i represents the impedance of the electrode i; L i represents the distance between the electrode i and the target tissue; C i1 represents the constant term of the corresponding calculation formula under the impedance range; C i2 C i3 represents the constant term of the corresponding calculation formula under the impedance range; k1 represents the parameter of the corresponding calculation formula under different impedance ranges; k2, k3 represent the parameters of the corresponding calculation formula under different impedance ranges.

[0075] Example 5:

[0076] As Figure 3 shown, this embodiment provides a pulsed electric field ablation system, including: a pulsed ablation catheter and a pulsed ablation host, and the pulsed ablation host is electrically connected to the pulsed ablation catheter;

[0077] A plurality of pulse electrodes are arranged on the pulsed ablation catheter, and the pulsed ablation host uses the impedance-based energy control method to control the pulse power of the pulse electrodes.

[0078] Preferably, when and only when the pulsed ablation catheter abuts against the target tissue, the pulsed ablation host measures the impedance between adjacent pulse electrodes among the pulse electrodes of the pulsed ablation catheter, calculates the comprehensive ablation parameter according to the impedance, and controls the pulse energy output power or pulse width length of each pulse electrode pair according to the comprehensive ablation parameter.

[0079] This embodiment refers to Figure 4 and Figure 5 , the test tissue is ex vivo potato tissue, pulsed ablation is performed at the same position, and the test electrode is a 10-electrode annular electrode. Figure 4 After the same energy is output by each electrode, a dye solution is selected for staining. After staining, 10 small petals can be observed, which is the position where the annular electrode is placed. After the electrode emits pulsed energy, it will cause irreversible electroporation damage to the potato tissue. The size of the stained area represents the size of the ablation area. Figure 5 For the test under the sampling energy output adjustment algorithm, it can be clearly observed that the ablation area becomes larger, and the ablation consistency of each electrode is very good.

[0080] Although the preferred embodiments of the present invention have been described, additional changes and modifications can be made to these embodiments by those skilled in the art once they learn the basic creative concept. Therefore, the appended claims are intended to be interpreted to include the preferred embodiments as well as all changes and modifications that fall within the scope of the present invention.

[0081] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention is also intended to include these modifications and variations.

Claims

1. An impedance-based energy control method, characterized in that, Applicable to a pulsed ablation catheter, comprising: Measuring the impedance between adjacent pulsed electrodes among the pulsed electrodes of the pulsed ablation catheter; Calculating a comprehensive ablation parameter according to the impedance and controlling the pulse energy output power or pulse width length of each pulsed electrode pair according to the comprehensive ablation parameter; When the impedance of the pulse electrode is less than the first threshold, according to the formula W i = Se i W0, the formula L i = C i3 , the formula Se i = q1Z i + q2L i calculate the pulse energy output power or the pulse width length; Among them, i represents different pulsed electrodes; Wi represents the power or pulse width length output by pulsed electrode i; W0 represents the lowest effective energy output when the pulsed electrode is in good contact; Se i represents the comprehensive ablation parameter of the pulsed electrode i; Z i represents the impedance of the electrode i; L i represents the distance between the electrode i and the target tissue; C i1 represents the constant term of the corresponding calculation formula under the impedance range; When the impedance of the pulse electrode is greater than the first threshold but less than the second threshold, according to the formula W i = Se i W0, formula L i = C i2 - e k2Zi + k3Z i , formula Se i = q1Z i + q2L i calculate the pulse energy output power or the pulse width length; Among them, C i2 , C i3 represent the constant terms of the corresponding calculation formulas in the impedance range; k2 and k3 represent the parameters of the corresponding calculation formulas in different impedance ranges; When the impedance of the pulse electrode is greater than the second threshold, according to the formula W i = Se i W0, the formula L i = C i1 + k1Z i , the formula Se i = q1Z i + q2L i calculate the pulse energy output power or the pulse width length; Wherein, k1 represents the parameter of the corresponding calculation formula in different impedance ranges.

2. An impedance-based energy control system applicable to a pulsed ablation catheter, characterized in that, Including: An impedance measurement module for measuring the impedance between adjacent pulsed electrodes among the pulsed electrodes of the pulsed ablation catheter; A power calculation and control module for calculating a comprehensive ablation parameter according to the impedance and controlling the pulse energy output power or pulse width length of each pulsed electrode pair according to the comprehensive ablation parameter; Specifically, the power calculation and control module includes: When the impedance of the pulse electrode is less than the first threshold, according to the formula W i = Se i W0, formula L i = C i3 、formula Se i = q1Z i + q2L i calculate the pulse energy output power or the pulse width length; where, i represents different pulse electrodes; Wi represents the power or the pulse width length output by the pulse electrode i; W0 represents the lowest effective energy output when the pulse electrode is in good contact; Se i represents the comprehensive ablation parameter of the pulse electrode i; Z i represents the impedance of the electrode i; L i represents the distance between the electrode i and the target tissue; C i1 represents the constant term of the corresponding calculation formula in the impedance range; When the impedance of the pulse electrode is greater than the first threshold but less than the second threshold, according to the formula W i = Se i W0, the formula L i = C i2 -e k2Zi + k3Z i , the formula Se i = q1Z i + q2L i calculate the pulse energy output power or the pulse width length; where C i2 , C i3 represent the constant terms of the corresponding calculation formulas in the impedance range; k2, k3 represent the parameters of the corresponding calculation formulas in different impedance ranges; When the impedance of the pulse electrode is greater than the second threshold, according to the formula W i = Se i W0, formula L i = C i1 + k1Z i , formula Se i = q1Z i + q2L i calculate the pulse energy output power or the pulse width length; where k1 represents the parameter of the corresponding calculation formula in different impedance ranges.

3. A pulsed electric field ablation system, characterized in that, Including: A pulsed ablation catheter and a pulsed ablation main unit, the pulsed ablation main unit being electrically connected to the pulsed ablation catheter; A plurality of pulsed electrodes are provided on the pulsed ablation catheter, and the pulsed ablation main unit controls the pulse power of the pulsed electrodes by using an impedance-based energy control method as claimed in claim 1.

4. The pulsed electric field ablation system according to claim 3, wherein, When and only when the pulsed ablation catheter abuts against the target tissue, the pulsed ablation main unit measures the impedance between adjacent pulsed electrodes among the pulsed electrodes of the pulsed ablation catheter, calculates a comprehensive ablation parameter according to the impedance, and controls the pulse energy output power or pulse width length of each pulsed electrode pair according to the comprehensive ablation parameter.

Citation Information

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