Pulsed Electric Field Ablation Control Device

Abstract

This application relates to the field of catheter mapping and ablation technology, and discloses a pulsed electric field ablation control device. The pulsed electric field ablation control device includes: an impedance detection part that finely detects the impedance of the tissue contacted by the electrode pair on the ablation catheter; a tissue thickness determination part that determines the thickness of the tissue according to the changes in the detected impedance under different contact conditions; and an ablation control part that controls the ablation catheter to output pulsed electric field ablation according to the determined thickness of the tissue. The focusing electrode of this application can accurately detect the impedance of the contacted tissue and the minute changes in impedance under different contact conditions, thereby calculating the tissue thickness and matching appropriate ablation parameters to avoid complications caused by excessive ablation parameters. In addition, the pulsed electric field ablation control technology of this application can determine the method and catheter for ablation depth, avoiding over-ablation.

Description

Technical Field

[0001] This application relates to the field of catheter mapping and ablation technologies, and more particularly to a pulsed electric field ablation control device. Background Art

[0002] The pulsed electric field technology applies a brief high voltage to tissue, which can generate a local high electric field of several hundred volts per centimeter. The local high electric field destroys cell membranes by creating pores in the cell membranes. The electric field applied at the membrane is greater than the cell threshold, so that the pores do not close, and this electroporation is irreversible, thereby allowing biomolecular materials to exchange through the membrane, resulting in cell necrosis or apoptosis. Pulsed irreversible electroporation ablation is different from physical therapies based on thermal ablation principles such as radiofrequency, cryoablation, microwave, and ultrasound. The irreversible electroporation damage of microsecond pulses to myocardial cell membranes is a non-thermal biological effect, which can effectively avoid damage to blood vessels, nerves, and esophagus. High-frequency pulsed electric fields that maintain the non-thermal advantage of irreversible electroporation are expected to overcome the problem of uneven internal electric field distribution caused by the cell membrane capacitance effect and the anisotropy of biological tissues. In the application scenario of bipolar pulses, after the end of a positive-polarity pulse train, a negative-polarity pulse train with the same pulse width and field strength is immediately applied, which may cause the action potential induced by the positive pulse not to fully generate in time, and the negative pulse causes the action potential to develop in the opposite direction, which will greatly reduce the nerve stimulation by the electric field.

[0003] The pulsed electric field ablation time is extremely short, and it is impossible to accurately control the ablation depth, and there is a risk of excessive ablation damage; at the same time, due to the large difference in the tissue thickness of the ablation site due to the heart location and individual differences, if the ablation parameters are selected and set to be small, ablation cannot be complete, and if the ablation parameters are selected and set to be large, there will be severe muscle tremor reactions and excessive ablation damage. Based on the above problems, in order to improve the success rate of pulsed electric field ablation and reduce the complications caused by ablation, a design that can calculate and measure tissue thickness, recommend ablation parameters according to the location and tissue thickness, and calculate the ablation depth is needed. Summary of the Invention

[0004] From the above description, it can be seen that the current pulsed ablation technology has the following problems:

[0005] 1. The pulsed ablation discharge time is short, and multiple superimposed ablations are required to achieve the ideal ablation depth, and the depth of pulsed ablation damage cannot be clearly grasped.

[0006] 2. There is a lack of an effective way to evaluate the tissue thickness of the ablation site.

[0007] The present application designs a pulsed electric field ablation control technique for the above problems. This technique is based on fine electrophysiological signal mapping and fine impedance detection, and can predict the thickness of the tissue to be ablated, so as to control the pulsed electric field ablation output of the ablation catheter. The "control" mentioned here includes determining ablation parameters, such as pulsed discharge voltage, single effective discharge time, pulse width, and superposition times, and also includes safety monitoring, ablation depth calculation, start and stop of the ablation process, etc.

[0008] According to a first aspect of the present application, there is provided a pulsed electric field ablation control method. The pulsed electric field ablation control method may include: performing fine impedance detection on the tissue contacted by the electrodes on the ablation catheter; determining the thickness of the tissue according to the change of the detected impedance under different contact conditions; and controlling the ablation catheter to perform pulsed electric field ablation output according to the determined thickness of the tissue.

[0009] Preferably, the control step may further include: determining ablation parameters based on the location of the tissue and the determined thickness of the tissue.

[0010] Preferably, the ablation parameters may include: pulsed discharge voltage, single effective discharge time, pulse width, and superposition times.

[0011] Preferably, the pulsed electric field ablation control method further includes: determining the location of the tissue contacted by the electrode according to the electrophysiological signal collected by the electrode.

[0012] Preferably, the contact condition includes the abutting pressure. In the pulsed electric field ablation control method according to the first aspect of the present application, the impedance detection step may include: collecting impedance values for the tissue under different abutting pressure conditions; and the tissue thickness determination step may include: comparing the change characteristics of the collected impedance values with the impedance value change characteristics of different tissue thicknesses stored in advance, and matching to obtain the thickness of the tissue.

[0013] Specifically, the change characteristics of the collected impedance values can be plotted as a curve, and the impedance value change characteristics of different tissue thicknesses stored in advance can be multiple basic curves reflecting the impedance value change characteristics of different tissue thicknesses drawn and saved in advance through experimental data. The step of matching to obtain the thickness of the tissue includes: when the change characteristic curve of the collected impedance values matches one of the multiple basic curves reflecting the impedance value change characteristics of different tissue thicknesses drawn and saved in advance through experimental data, determining the thickness of the tissue as the tissue thickness reflected by the matched basic curve.

[0014] Preferably, the collected impedance value may be the difference between the real-time detected impedance value and the impedance value in the blood.

[0015] During the output of pulsed electric field ablation, when a real-time impedance mutation is detected, the control step may further include: immediately stopping the output of the pulsed electric field ablation.

[0016] Preferably, the control step may further include: controlling whether the ablation catheter continues to perform the output of pulsed electric field ablation according to the comparison result between the real-time ablation depth and the thickness of the tissue.

[0017] Preferably, the pulsed electric field ablation control method may further include: calculating the real-time ablation depth according to the ablation parameters and the real-time apposition pressure during the output of pulsed electric field ablation.

[0018] The real-time ablation depth can be calculated according to the following formula:

[0019] ,

[0020] where PFADepth is the real-time ablation depth, V is the pulsed discharge voltage, T is the single effective discharge time, u is the pulse width, n is the superposition times, CF is the real-time apposition pressure, t is the time variable, and C, α, and β are correction coefficients.

[0021] The control step may further include: when the real-time ablation depth is less than the thickness of the tissue, controlling the ablation catheter to continue the output of pulsed electric field ablation; when the real-time ablation depth is equal to the thickness of the tissue, controlling the ablation catheter to stop ablation.

[0022] Preferably, the pulsed electric field ablation control method may further include: estimating the ablation damage range in the tissue according to the real-time damage detection result. Thus, the control step may further include: controlling whether the ablation catheter continues to perform the output of pulsed electric field ablation according to the ablation damage range in the tissue.

[0023] Preferably, the ablation catheter includes an optical sensor disposed between the electrodes, and the ablation damage estimation step may include: estimating the ablation damage range in the tissue according to the optical signal detected by the optical sensor.

[0024] Similarly, the ablation catheter includes an ultrasonic sensor disposed between the electrodes, and the ablation damage estimation step may include: estimating the ablation damage range in the tissue according to the ultrasonic imaging signal detected by the ultrasonic sensor.

[0025] Preferably, the pulsed electric field ablation control method may further include: during the output of pulsed electric field ablation, calculating a real-time ablation depth according to ablation parameters and real-time apposition pressure. The ablation damage estimation step may further include: mutually correcting the real-time damage detection result and the calculated real-time ablation depth to estimate the ablation damage range in the tissue.

[0026] Preferably, the contact condition may further include the apposition direction and position relationship, and the morphology of the ablation catheter.

[0027] The electrodes on the ablation catheter may be bipolar electrodes and the distance between different polar electrodes is minimized.

[0028] According to a second aspect of the present application, there is provided a pulsed electric field ablation control device. The pulsed electric field ablation control device may include: an impedance detection part for finely detecting the impedance of the contacted tissue using the electrodes on the ablation catheter; a tissue thickness determination part for determining the thickness of the tissue according to the change of the detected impedance under different contact conditions; an ablation control part for controlling the ablation catheter to output pulsed electric field ablation according to the determined thickness of the tissue.

[0029] Preferably, the ablation control part may further include an ablation parameter determination unit for determining ablation parameters based on the part of the tissue and the determined thickness of the tissue.

[0030] Preferably, the ablation parameters may include: pulsed discharge voltage, single effective discharge time, pulse width, and number of superpositions.

[0031] Preferably, the pulsed electric field ablation control device further includes a tissue part determination part for determining the part of the tissue that the electrode is contacting according to the electrophysiological signal collected by the electrode.

[0032] Preferably, the contact condition includes apposition pressure. In the pulsed electric field ablation control device according to the second aspect of the present application, the impedance detection part may be configured to: collect impedance values for the tissue under different apposition pressure conditions; the tissue thickness determination part may be configured to: compare the change characteristics of the collected impedance values with the impedance value change characteristics of different tissue thicknesses stored in advance, and match to obtain the thickness of the tissue.

[0033] Specifically, the variation characteristics of the collected impedance values can be plotted as curves. The impedance value variation characteristics of different tissue thicknesses stored in advance can be multiple basic curves that are pre-drawn and saved through experimental data to reflect the impedance value variation characteristics of different tissue thicknesses. The matching to obtain the thickness of the tissue includes: when the variation characteristic curve of the collected impedance value matches one of the multiple basic curves that are pre-drawn and saved through experimental data to reflect the impedance value variation characteristics of different tissue thicknesses, determining the thickness of the tissue as the tissue thickness reflected by the matched basic curve.

[0034] Preferably, the collected impedance value can be the difference between the real-time detected impedance value and the impedance value in the blood.

[0035] During the output of pulsed electric field ablation, when the impedance detection part detects a real-time impedance mutation, the ablation control part can be further configured to immediately stop the output of the pulsed electric field ablation.

[0036] Preferably, the ablation control part can be further configured to: control whether the ablation catheter continues to perform the output of pulsed electric field ablation according to the comparison result between the real-time ablation depth and the thickness of the tissue.

[0037] Preferably, the pulsed electric field ablation control device can further include an ablation depth determination part, which calculates the real-time ablation depth according to ablation parameters and real-time abutting pressure during the output of pulsed electric field ablation.

[0038] The ablation depth determination part can calculate the real-time ablation depth according to the following formula:

[0039] ,

[0040] where PFADepth is the real-time ablation depth, V is the pulsed discharge voltage, T is the single effective discharge time, u is the pulse width, n is the superposition times, CF is the real-time abutting pressure, t is the time variable, and C, α, and β are correction coefficients.

[0041] The ablation control part can be further configured to: when the real-time ablation depth is less than the thickness of the tissue, control the ablation catheter to continue the output of pulsed electric field ablation; when the real-time ablation depth is equal to the thickness of the tissue, control the ablation catheter to stop ablation.

[0042] Preferably, the pulsed electric field ablation control device can further include an ablation damage estimation part, which estimates the ablation damage range in the tissue according to the real-time damage detection result. Thus, the ablation control part can be further configured to: control whether the ablation catheter continues to perform the output of pulsed electric field ablation according to the ablation damage range in the tissue.

[0043] Preferably, the ablation catheter includes an optical sensor disposed between the electrodes, and the ablation damage estimation part may be configured to estimate the range of ablation damage in the tissue according to the optical signal detected by the optical sensor.

[0044] Similarly, the ablation catheter includes an ultrasonic sensor disposed between the electrodes, and the ablation damage estimation part may be configured to estimate the range of ablation damage in the tissue according to the ultrasonic imaging signal detected by the ultrasonic sensor.

[0045] Preferably, the pulsed electric field ablation control device may further include an ablation depth determination part, which calculates the real-time ablation depth according to ablation parameters and real-time abutting pressure during the output of pulsed electric field ablation. The ablation damage estimation part may be further configured to mutually correct the real-time damage detection result and the calculated real-time ablation depth to estimate the range of ablation damage in the tissue.

[0046] Preferably, the contact condition may further include the abutting direction and positional relationship and the shape of the ablation catheter.

[0047] The electrodes on the ablation catheter may be bipolar electrodes and the distance between electrodes of different polarities is minimized.

[0048] According to a third aspect of the present application, there is provided a non-transitory computer-readable storage medium for storing a computer program. The computer program includes instructions. When the instructions are executed by a processor of an electronic device, the electronic device implements the pulsed electric field ablation control method as described in the first aspect of the present application.

[0049] According to a fourth aspect of the present application, there is provided a pulsed electric field ablation system. The pulsed electric field ablation system may include a pulsed electric field ablation catheter and a controller. The controller is configured to execute the pulsed electric field ablation control method as described in the first aspect of the present application according to computer instructions.

[0050] The ablation catheter of the present application uses a focused electrode, which can accurately detect the impedance of the contacted tissue and the minute changes in impedance under different contact conditions. Thus, the pulsed electric field ablation control technology of the present application can calculate the tissue thickness by accurately detecting impedance changes and match appropriate ablation parameters, avoiding complications caused by excessive ablation parameters. In addition, the pulsed electric field ablation control technology of the present application can determine the method and catheter for ablation depth, avoiding over-ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] The present application will be more fully understood through the following detailed description in conjunction with the accompanying drawings, in which like elements are numbered in a similar manner, where:

[0052] Figure 1 It is a schematic diagram of ablating thick myocardial tissue.

[0053] Figure 2 It is a schematic diagram of ablating thin myocardial tissue.

[0054] Figure 3 It is a schematic diagram of ablating thick myocardial tissue under sufficient apposition pressure.

[0055] Figure 4 It is a schematic diagram of the first tip electrode arrangement of a bipolar pulsed electric field ablation catheter.

[0056] Figure 5 It is a schematic diagram of the second tip electrode arrangement of a bipolar pulsed electric field ablation catheter.

[0057] Figure 6 It is a schematic diagram of the third tip electrode arrangement of a bipolar pulsed electric field ablation catheter.

[0058] Figure 7 It is a schematic diagram of the fourth tip electrode arrangement of a bipolar pulsed electric field ablation catheter.

[0059] Figure 8 It is a schematic diagram of the ablation damage of the tip electrode.

[0060] Figure 9 It is a flowchart of the pulsed electric field ablation control method according to an embodiment of the present application.

[0061] Figure 10 It is a schematic diagram of the electrode slightly contacting the tissue.

[0062] Figure 11 It is a schematic diagram when the pressure of the electrode contacting the tissue increases.

[0063] Figure 12 It is a schematic diagram of the impedance change corresponding to different apposition pressures.

[0064] Figure 13 It shows the effects after different numbers of ablations.

[0065] Figure 14 It is a schematic diagram of an abnormal impedance mutation during ablation.

[0066] Figure 15 It shows the ablation tip with an optical sensor.

[0067] Figure 16 It shows the ablation tip with an ultrasonic sensor.

[0068] Figure 17 It shows an example of the distribution of the positioning sensors in the ablation catheter.

[0069] Figure 18 It is a schematic diagram of a pressure sensor in an ablation catheter.

[0070] Figure 19 It is a schematic block diagram of a pulsed electric field ablation control device and an ablation catheter according to an embodiment of the present application.

[0071] Reference numerals:

[0072] 1 Ablation electrode

[0073] 2 Myocardial tissue

[0074] 221 Thick myocardial tissue

[0075] 222 Thin myocardial tissue

[0076] 3 Ablation damage range

[0077] 41 First ablation electrode

[0078] 42 Second ablation electrode

[0079] 51 Third ablation electrode

[0080] 52 Fourth ablation electrode

[0081] 53 Fifth ablation electrode

[0082] 54 Sixth ablation electrode

[0083] 61 First main body head electrode

[0084] 62 Microelectrode

[0085] 71 Second main body head electrode

[0086] 72 Tubular electrode

[0087] 8 Saline

[0088] 9 Tube body

[0089] 10 Pressure sensor

[0090] 11 Optical sensor

[0091] 12 Ultrasonic sensor

[0092] 13 Plant tissue

[0093] 14 Traction member

[0094] 15 First magnetic positioning sensor

[0095] 16 Second magnetic positioning sensor

[0096] 311 Damage range of one ablation

[0097] The damage range after three times of ablation at 312

[0098] The damage range after five times of ablation at 313

[0099] 171 Elastomer

[0100] 172 First strain sensor

[0101] 173 Second strain sensor

[0102] 174 Third strain sensor Detailed implementation manners

[0103] The technical solutions of the present application will be further described in detail below through embodiments and in conjunction with the accompanying drawings. However, the present application is not limited to the following embodiments.

[0104] Figure 1 It is a schematic diagram of ablating thick myocardial tissue. Figure 2 It is a schematic diagram of ablating thin myocardial tissue. Figure 3 It is a schematic diagram of ablating thick myocardial tissue under sufficient apposition pressure.

[0105] As Figures 1 to 3 shown, when the ablation electrode 1 performs ablation under the condition of setting the same ablation parameters, the ablation damage range 3 is basically the same; however, Figure 1 as shown, the thick myocardial tissue 221 is relatively thick and it is difficult to ablate through the wall; Figure 2 as shown, the thin myocardial tissue 222 is relatively thin, and it can easily penetrate the wall and damage the surrounding tissues; compared with Figure 1 , Figure 3 under sufficient apposition pressure, the thick myocardial tissue 221 can also be ablated through the wall. Figure 13 shows the effects after different numbers of ablations. As Figure 13 shown, under the condition of the same parameters, the ablation depth on the plant tissue 13 is shown as the damage range 311 after one ablation, the damage range 312 after three ablations, and the damage range 313 after five ablations in the figure. It can be seen from Figure 13 that as the number of ablations increases, the ablation depth, that is, the damage range shown, also increases; therefore, the factors affecting the ablation damage through-wall effect are directly related to the apposition pressure, tissue thickness, ablation parameters, and superposition times.

[0106] In the bipolar pulsed electric field ablation catheter of the prior art, the number of electrodes is even and they are linearly distributed along the axis at the distal end of the catheter. Currently, this design has the problem that the ablation damage site cannot be accurately focused: the contact position is the head electrode, and the discharge ablation range is the area between the head electrode and the rear electrode; due to the axial linear arrangement, the rear electrode is usually suspended, and when discharging, it does not contact the tissue but discharges and ablates in the blood; in this way, part of the energy will flow into the blood, affecting the ablation damage efficiency; at the same time, excessive ablation in the blood may cause unnecessary damage to the red blood cells in the blood and lead to complications such as renal failure.

[0107] To avoid the problem of unfocused ablation, the ablation electrode design adopted in this application can be as Figures 4 to 7 shown.

[0108] As Figure 4 shown, in the first distal end electrode arrangement of the bipolar pulsed electric field ablation catheter, the first ablation electrode 41 and the second ablation electrode 42 are arranged at the topmost end of the catheter. When discharging and ablating, the first ablation electrode 41 and the second ablation electrode 42 form a discharge ablation circuit. The first ablation electrode 41 and the second ablation electrode 42 have opposite polarities, and the electrode surface areas of the first ablation electrode 41 and the second ablation electrode 42 are equal. This area is the area where the catheter is in the most direct contact with the tissue, and the ablation energy can be fully applied to the tissue. Figure 8 This is a schematic diagram of the ablation damage of the distal end electrode. As Figure 8 shown, an ablation electrode ablates the myocardial tissue 2, and the ablation damage range 3 is hemispherical, and the ablation energy is concentrated in the myocardial tissue 2. In addition, Figure 4 it also shows the catheter body 9 of the ablation catheter and the pressure sensor 10 inside the catheter body, and their related functions will be further described in detail later.

[0109] As Figure 5 shown, in the second distal end electrode arrangement of the bipolar pulsed electric field ablation catheter, the third ablation electrode 51, the fourth ablation electrode 52, the fifth ablation electrode 53, and the sixth ablation electrode 54 are evenly and symmetrically distributed along the central axis of the catheter. The electrode surface areas of the third ablation electrode 51, the fourth ablation electrode 52, the fifth ablation electrode 53, and the sixth ablation electrode 54 are equal, the polarities of the ablation electrodes are opposite in pairs, and the electrode spacing is 0.1 - 1 mm. The ablation damage area is concentrated at the distal end of the catheter, realizing precise focused ablation. In addition, Figure 5 it also shows the catheter body 9 of the ablation catheter.

[0110] As Figure 6As shown, in the third head electrode arrangement of the bipolar pulsed electric field ablation catheter, a microelectrode 62 is arranged at the top of the first main body head electrode 61, and 3-6 microelectrodes 62 are arranged laterally and evenly. During ablation, the first main body head electrode 61 and the microelectrode 62 have opposite polarities, the electrode surface area of the first main body head electrode 61 is equal to the sum of the electrode surface areas of all microelectrodes 62, the first main body head electrode 61 and all microelectrodes 62 are independently insulated from each other, and the minimum distance is 0.10-1 mm. The ablation damage area is concentrated at the catheter head end, realizing focused and precise ablation. In addition, Figure 6 The tube body 9 of the ablation catheter is also shown.

[0111] As Figure 7 shown, in the fourth head electrode arrangement of the bipolar pulsed electric field ablation catheter, a tubular electrode 72 is arranged inside the second main body head electrode 71. During ablation, the surface area of the second main body head electrode 71 is less than or equal to the inner surface area of the tubular electrode 72, the second main body head electrode 71 and the tubular electrode 72 have opposite polarities, the minimum electrode distance is 0.10-1.0 mm, and the ablation damage area is concentrated at the catheter head end, realizing focused and precise ablation. During ablation, normal saline 8 is continuously perfused inside the tubular electrode 72. The contacted second main body head electrode 71 directly contacts the tissue and forms a circuit with the tubular electrode 72 through the tissue or blood and normal saline 8. Since the tubular electrode 72 only contacts normal saline 8 constantly inside, the tissue impedance contacted by the second main body head electrode 71 can also feedback fine local impedance values. In addition, Figure 7 The tube body 9 of the ablation catheter and the pressure sensor 10 inside the tube body are also shown, and their related functions will be further described in detail later.

[0112] Figures 4 to 7 In the electrode arrangements shown, the distances between the electrodes are all micro distances, and all can accurately map the electrophysiological signals of the head end contacting the tissue and the local impedance between the head end electrode and the tissue.

[0113] Taking Figure 4 the shown way as an example, the distance between the first ablation electrode 41 and the second ablation electrode 42 is 0.40-1.30 mm. The smaller the electrode distance, the better the quality of the collected electrophysiological signals, and the more accurate the judgment of the tissue location through the electrophysiological signals. Since the electrode head end directly contacts the tissue, the electrode head end can directly collect the impedance of the first ablation electrode 41 and the second ablation electrode 42, and the collected impedance value is accurate, avoiding the inaccurate measurement problem caused by the rear electrode being suspended in the blood when the traditional front end electrode collects the impedance of the rear electrode. Based on the fine electrophysiological signal mapping and fine impedance monitoring, the tissue location is determined and the tissue thickness is predicted, so as to give matching ablation parameters. After knowing the contact pressure, ablation parameters, and superposition times, the ablation depth can be calculated.

[0114] This application proposes a method and device for controlling pulsed electric field ablation. The specific embodiments of this application will be described below from the perspectives of the method and the device respectively.

[0115] Control method

[0116] As described above, based on precise electrophysiological signal mapping and fine impedance monitoring, the tissue site to be ablated can be determined and the tissue thickness can be predicted, so as to control the ablation catheter to output pulsed electric field ablation. The "control" described in this application includes determining ablation parameters, such as pulsed discharge voltage, single effective discharge time, pulse width, and superposition times, and also includes safety monitoring, ablation depth calculation, start and stop of the ablation process, etc.

[0117] Figure 9 is a flowchart of the pulsed electric field ablation control method according to an embodiment of this application.

[0118] As Figure 9 shown, the pulsed electric field ablation control method 900 according to an embodiment of this application starts at step S910, in which the tissue contacted by the electrodes on the ablation catheter is finely impedance detected.

[0119] In step S920, the thickness of the tissue is determined according to the change of the detected impedance under different contact conditions.

[0120] The contact described here can also be referred to as abutment. Those skilled in the art should understand that in the context of this application, these two terms can be used interchangeably to express the same meaning. The contact conditions in step S920 can include the abutment pressure as described above. In a preferred embodiment, step S910 can specifically include: collecting impedance values for the tissue under different abutment pressure conditions. Correspondingly, step S920 can specifically include: comparing the change characteristics of the collected impedance values with the impedance value change characteristics of different tissue thicknesses stored in advance, and matching to obtain the thickness of the tissue. Specifically, the change characteristics of the collected impedance values can be plotted as a curve. The impedance value change characteristics of different tissue thicknesses stored in advance can be multiple base curves reflecting the impedance value change characteristics of different tissue thicknesses drawn and saved in advance through experimental data. In other words, in the pre-stored base curves, each curve represents a tissue thickness. The above-mentioned matching to obtain the thickness of the tissue is specifically implemented as follows: when the change characteristic curve of the collected impedance values matches one of the multiple base curves reflecting the impedance value change characteristics of different tissue thicknesses drawn and saved in advance through experimental data, the thickness of the tissue is determined as the tissue thickness reflected by the matched base curve. In a preferred embodiment, the actually collected impedance values here are actually the difference between the real-time detected impedance values and the impedance values in the blood.

[0121] Those skilled in the art should understand that in some embodiments, the contact conditions described herein may further include the direction and positional relationship of abutment and the morphology of the ablation catheter.

[0122] In step S930, according to the determined thickness of the tissue, control the ablation catheter to perform pulsed electric field ablation output.

[0123] The control described in step S930 may further include determining ablation parameters.

[0124] According to a preferred embodiment of the present application, the determination of ablation parameters needs to be based on the determination of the site of the tissue to be ablated and the determination of the thickness of the tissue. Therefore, in addition to step S920, the control method 900 may further need to include an additional step, that is, determining the site of the tissue in contact with the electrode according to the electrophysiological signals collected by the electrode of the ablation catheter.

[0125] Here, the ablation parameters may include: pulsed discharge voltage, single effective discharge time, pulse width, number of superpositions. Of course, the ablation parameters may also be narrow-sense single ablation parameters, that is, they do not include the number of superpositions, but only include the parameters of single ablation, such as pulsed discharge voltage, single effective discharge time, pulse width, etc.

[0126] During the pulsed electric field ablation output, when a real-time impedance mutation is detected, step S930 may further include: immediately stopping the pulsed electric field ablation output to ensure the safety of ablation.

[0127] In addition, as mentioned above, the "control" described in step S930 also includes the calculation of ablation depth. Specifically, in a preferred embodiment, during the pulsed electric field ablation output, calculate the real-time ablation depth according to the ablation parameters (including pulsed discharge voltage, single effective discharge time, pulse width, number of superpositions, etc.) and the real-time abutment pressure. More detailed examples are given in the following embodiments.

[0128] Then, according to the comparison result of the real-time ablation depth and the thickness of the tissue, it is also possible to control whether the ablation catheter continues to perform pulsed electric field ablation output. Specifically, when the real-time ablation depth is less than the thickness of the tissue, control the ablation catheter to continue performing pulsed electric field ablation output. And when the real-time ablation depth is equal to the thickness of the tissue, control the ablation catheter to stop ablation.

[0129] As mentioned above, the "control" described in step S930 also includes safety monitoring. Specifically, according to the real-time damage detection result, estimate the ablation damage range in the tissue.

[0130] For example, an ablation catheter may include an optical sensor disposed between electrodes. Based on the optical signals detected by the optical sensor, the scope of ablation damage in the tissue can be estimated.

[0131] Alternatively, the ablation catheter may include an ultrasonic sensor disposed between electrodes. Based on the ultrasonic imaging signals detected by the ultrasonic sensor, the scope of ablation damage in the tissue can be estimated.

[0132] The above real-time damage detection results, whether from an optical sensor or an ultrasonic sensor, can be mutually corrected with the calculated real-time ablation depth, so as to more accurately estimate the scope of ablation damage in the tissue. As described above, during the pulsed electric field ablation output, the real-time ablation depth can be calculated according to the ablation parameters and the real-time contact pressure.

[0133] Furthermore, according to the scope of ablation damage in the tissue, it is controlled whether the ablation catheter continues to perform pulsed electric field ablation output.

[0134] As described above, since the method of the present application is based on the accurate detection of tissue impedance, the recommended arrangement of aggregation electrodes in the present application has been given above. Refer to Figures 4 to 7 Generally speaking, the electrodes on the ablation catheter can be bipolar electrodes and it is necessary to minimize the distance between electrodes of different polarities.

[0135] Embodiment 1 - Determination of Tissue Site

[0136] The approximate position of the electrode can be judged by detecting electrophysiological signals. If the electrophysiological signals collected by the electrode only have atrial waveforms, it proves that it is in the atrium; if the collected electrophysiological signals only have ventricular waveforms, it proves that it is in the ventricle; if the collected waveforms have both atrial waveforms and ventricular waveforms, then look at the amplitudes of the atrial waveforms and ventricular waveforms: if the amplitudes are the same, it is judged to be at the tricuspid annulus or mitral annulus position; if the atrial amplitude is large and the ventricular amplitude is small, it is judged to be near the annulus and biased towards the atrial side; if the atrial amplitude is small and the ventricular amplitude is large, it is judged to be near the cardiac annulus and biased towards the ventricular side. Based on the characteristics of electrophysiological signals, the position of the catheter can be basically determined. Since the atrial wall is thinner, the ventricular wall is thicker, and muscle fibrillation is more likely to occur during ablation in the atrium, different parameters are selected at different sites.

[0137] Embodiment 2 - Determination of Tissue Thickness

[0138] As Figure 10 shown, when the first ablation electrode 41 and the second ablation electrode 42 slightly contact the myocardial tissue 2, that is, when the contact pressure is small, the contact area between the electrode and the tissue is small, and the electrode is mostly in contact with the blood. Since the impedance of the tissue is higher than that of the blood, the impedance value collected by the electrode at this time is relatively small.

[0139] As Figure 11As shown, when the pressure between the first ablation electrode 41 and the second ablation electrode 42 in contact with the myocardial tissue 2 increases, i.e., when the abutting pressure increases, the contact area between the electrode and the tissue increases, and the contact area between the electrode and the blood decreases. Since the impedance of the tissue is higher than that of the blood, the impedance value collected by the electrode increases relatively more at this time.

[0140] Figure 12 is a schematic diagram of the impedance change corresponding to different abutting pressures. As Figure 12 shown, based on the above impedance detection characteristics, for the same tissue under different pressure conditions, the impedance value ΔR collected by the electrode (ΔR is the difference between the real-time impedance value and the impedance value in the blood) will increase accordingly. Plotting this characteristic as a curve gives the curves T1, T2, or T3 in the figure. For different myocardial tissues, such as the atrium and ventricle, the change curve graphs will be different, so the tissue thicknesses represented by T1, T2, and T3 increase in sequence. For example, as Figure 12 shown in the example, the curves from T1 to T3 are three basic curves plotted and saved in advance through experimental data, reflecting the impedance value change characteristics of three different tissue thicknesses. In other words, in the pre-stored basic curves, each curve represents a tissue thickness. In clinical practice, by detecting the change curve of ΔR and pressure F through the contact between the electrode and the tissue (and plotting according to the detection results), and matching the detected curve with the basic curve, the tissue thickness can be calculated. That is, when the detected curve matches one of the multiple basic curves plotted and saved in advance through experimental data, reflecting the impedance value change characteristics of different tissue thicknesses, the thickness of the tissue is determined to be the tissue thickness reflected by the matched basic curve.

[0141] Embodiment 3 - Selection of Ablation Parameters

[0142] Based on the tissue location determined in Embodiment 1 and the tissue thickness determined in Embodiment 2, the ablation parameters are determined.

[0143] In a preferred embodiment, the ablation parameters can be expressed as:

[0144]

[0145] where V is the pulse discharge voltage, T is the single effective discharge time, u is the pulse width, and n is the number of superpositions. That is, in this preferred embodiment, the ablation parameters include the pulse discharge voltage, the single effective discharge time, the pulse width, and the number of superpositions.

[0146] Embodiment 4 - Safety Monitoring

[0147] Safety monitoring can be carried out during the ablation process. Since the impedance detected by the electrode is very delicate and sensitive, as Figure 14As shown, during the discharge process, if the local impedance between the detection electrodes suddenly increases, that is, an impedance mutation occurs, it indicates that relatively large microbubbles are generated, and the feedback control system immediately stops ablation.

[0148] Embodiment 5 - Calculating the real-time ablation depth

[0149] During the output process of pulsed electric field ablation, calculate the real-time ablation depth according to the ablation parameters and the real-time apposition pressure.

[0150] The real-time ablation depth can be calculated according to the following formula:

[0151] ,

[0152] where PFADepth is the real-time ablation depth, V is the pulsed discharge voltage, T is the single effective discharge time, u is the pulse width, n is the superposition times, CF is the real-time apposition pressure, t is the time variable, and C, α, and β are correction coefficients.

[0153] Embodiment 6 - Stopping ablation

[0154] During the ablation process, calculate the ablation depth in real time, and compare the calculated real-time ablation depth with the tissue thickness collected before ablation. If the real-time ablation depth is less than the tissue thickness, continue ablation until the ablation depth reaches the tissue thickness.

[0155] More generally, the determination of whether to stop ablation is based on the current damage assessment. That is to say, if the current damage assessment shows that the damage range reaches the target, for example, the damage range reaches the tissue thickness at least in one dimension (i.e., the ablation depth), ablation can be stopped. Conversely, if the current damage assessment shows that the damage range does not reach the target, for example, the damage range does not penetrate the tissue thickness, ablation can continue to be implemented.

[0156] The damage assessment can also be obtained in the following way.

[0157] Figure 15 An ablation head end with an optical sensor is shown. As Figure 15 shown, the optical sensor 11 is arranged between the first ablation electrode 41 and the second ablation electrode 42, and the real-time damage depth of the ablated tissue can be detected. The detection principle is: light is scattered inside the tissue, and the internal tissue structure analysis is based on the principle of coherent light interference measurement. In the low-coherence light interference measurement method, light is split and transmitted along two directions, and the light reflected or scattered from the target along one path is combined or interfered with the light reflected from another known reference path. This interference signal is collected by a photodetector and analyzed to determine the tissue structure, and then the damaged and non-damaged ranges are distinguished. The optical detection of the ablation damage range can be mutually corrected with the ablation depth calculated in Embodiment 5 to make the damage assessment more accurate and comprehensive.

[0158] Figure 16 shows an ablation tip with an ultrasonic sensor. As Figure 16 shown, the ultrasonic sensor 12 is arranged between the first ablation electrode 41 and the second ablation electrode 42, and can detect the real-time damage depth of the ablated tissue. The ultrasonic imaging principle is: different echoes generated by the differences in acoustic impedance and attenuation of different tissues form an image. By comparing the images, the boundary between the damaged tissue and the normal tissue is distinguished, and then the damage depth range is determined. The ultrasonic detection of the ablation damage range can be mutually corrected with the ablation depth calculated in Embodiment 5, making the damage assessment more accurate and comprehensive.

[0159] Embodiment 7 - Contact (abutting) situation

[0160] According to the concept of the present application, the described contact situation not only includes the abutting pressure, but may also include the abutting direction and positional relationship, as well as the shape of the ablation catheter. These contact situations can be measured or evaluated by means of a positioning sensor, a pressure sensor, etc.

[0161] Figure 17 shows an example of the distribution of the positioning sensors in the ablation catheter. As Figure 17 shown, a traction member 14 is provided at the distal end of the catheter. One end of the entire traction device is arranged at the catheter tip, and the other end is arranged at the proximal handle assembly. The traction member 14, as a member of the traction device, is arranged inside the bending direction of the catheter. The traction member 14 is arranged away from the catheter axis. The catheter bending plane is perpendicular to the line connecting the electrodes, that is, the center between the two electrodes is the bending direction point, which is used to indicate the bending direction. The first magnetic positioning sensor 15 and the second magnetic positioning sensor 16 are respectively arranged at the distal end and the proximal end of the distal tube body, and are used to calculate and display the bending shape of the distal tube body. The first magnetic positioning sensor 15 is composed of two magnetic positioning sensors and forms a certain included angle, and the angle is 5 - 20°, which is used to cooperate with the pressure sensor to feedback the catheter abutting direction.

[0162] Figure 18 is a schematic diagram of the pressure sensor in the ablation catheter. When the catheter tip contacts the tissue, it is necessary to determine the position and direction of the contact between the catheter tip and the tissue. Therefore, as Figure 18 shown in the above figure, a pressure sensor 10 is arranged inside the catheter tip. As Figure 18As shown in the following figure, the pressure sensor 10 includes an elastomer 171 and a first strain sensor 172, a second strain sensor 173, and a third strain sensor 174 symmetrically arranged on the elastomer 171. Preferably, the number of strain sensors is set to be greater than or equal to 3. Preferably, three strain sensors are set, and the included angle between the strain sensors is 120°. The zero position (the center point between the electrodes) is aligned with the first strain sensor 172. This method relates the contact position determined by the pressure sensor to the positional relationship determined by the magnetic positioning sensor. The X-axis component force Fx, the Y-axis component force Fy, and the Z-axis component force Fz are all pre-calibrated data and are known data. The relationships of Fx, Fy, and Fz with respect to the zero position are known. The included angle between the lateral component force (Fside) and Fx is ∠b, and can be calculated. Then, since the relationship between Fx and the zero position is known, the angular relationship of ∠b with respect to the zero position can be calculated. Through ∠a = arctan(Fz / Fside), the included angle between the resultant force (Fresultant) direction and the lateral force can be determined, and thus the relationship between the resultant force direction and the zero position can be indirectly calculated. Through the calculated ∠a and ∠b, the direction of the catheter in contact with the tissue (relative to the zero position) can be determined. The positional relationship between the zero position and the adjustable bending section of the catheter body is known from the above. Overall, the contact direction and positional relationship between the catheter tip and the tissue and the morphology of the catheter can be determined.

[0163] Control device

[0164] Figure 19 is a schematic block diagram of a pulsed electric field ablation control device and an ablation catheter according to an embodiment of the present application.

[0165] As Figure 19 shown, the pulsed electric field ablation control device 1900 according to an embodiment of the present application includes an impedance detection part 1910, a tissue thickness determination part 1920, and an ablation control part 1930. Those skilled in the art should understand that the impedance detection part 1910, the tissue thickness determination part 1920, and the ablation control part 1930 can respectively perform operations corresponding to steps S910, S920, and S930 in Figure 9 method 900.

[0166] Specifically, the impedance detection part 1910 uses the electrodes on the ablation catheter to perform fine impedance detection on the contacted tissue. Figure 19 The arrow from the ablation catheter to the impedance detection part 1910 in can indicate that the electrophysiological signal measured by the catheter through the electrodes is sent to the impedance detection part 1910 for fine impedance detection. The tissue thickness determination part 1920 determines the thickness of the tissue according to the change of the impedance detected by the impedance detection part 1910 under different contact conditions. The ablation control part 1930 controls the ablation catheter to output pulsed electric field ablation according to the thickness of the tissue determined by the tissue thickness determination part 1920.Figure 19 The arrow from the ablation control section 1930 to the ablation catheter may indicate that the ablation control section 1930 controls the ablation output of the ablation catheter.

[0167] The ablation control section 1930 may further include an ablation parameter determination unit (not shown) for determining ablation parameters based on the location of the tissue and the determined thickness of the tissue. Here, the ablation parameters may include: pulsed discharge voltage, single effective discharge time, pulse width, and number of superpositions. In a preferred embodiment, the pulsed electric field ablation control device 1900 may further include a tissue location determination section (not shown) for determining the location of the tissue that the electrode is in contact with according to the electrophysiological signals collected by the electrode.

[0168] The contact condition between the catheter (more specifically, the electrode on the catheter) and the tissue can be characterized by the abutting pressure. The impedance detection section 1910 may collect impedance values for the tissue under different abutting pressure conditions. Correspondingly, the tissue thickness determination section 1920 may compare the variation characteristics of the collected impedance values with the impedance value variation characteristics of different tissue thicknesses stored in advance, and match to obtain the thickness of the tissue. Specifically, the variation characteristics of the collected impedance values are plotted as a curve, and the impedance value variation characteristics of different tissue thicknesses stored in advance are multiple base curves that are pre-drawn and saved through experimental data to reflect the impedance value variation characteristics of different tissue thicknesses. When the variation characteristic curve of the collected impedance values matches one of the multiple base curves that are pre-drawn and saved through experimental data to reflect the impedance value variation characteristics of different tissue thicknesses, the thickness of the tissue is determined to be the tissue thickness reflected by the matched base curve. Preferably, the collected impedance value is the difference between the real-time detected impedance value and the impedance value in the blood.

[0169] During the pulsed electric field ablation output, when the impedance detection section 1910 detects a real-time impedance mutation, the ablation control section 1930 may also immediately stop the pulsed electric field ablation output.

[0170] The ablation control section 1930 may also control whether the ablation catheter continues to perform pulsed electric field ablation output according to the comparison result between the real-time ablation depth and the tissue thickness. For example, the pulsed electric field ablation control device 1900 may further include an ablation depth determination section (not shown) for calculating the real-time ablation depth according to the ablation parameters and the real-time abutting pressure during the pulsed electric field ablation output. In a preferred embodiment, the ablation depth determination section calculates the real-time ablation depth according to the following formula:

[0171] ,

[0172] Wherein, PFADepth is the real-time ablation depth, V is the pulse discharge voltage, T is the single effective discharge time, u is the pulse width, n is the superposition times, CF is the real-time apposition pressure, t is the time variable, and C, α, and β are correction coefficients.

[0173] The ablation control part 1930 can control the ablation catheter to continue the pulsed electric field ablation output when the real-time ablation depth is less than the tissue thickness, and control the ablation catheter to stop ablation when the real-time ablation depth is equal to the tissue thickness.

[0174] The pulsed electric field ablation control device may further include an ablation damage estimation part (not shown) for estimating the ablation damage range in the tissue according to the real-time damage detection result. In this case, the ablation control part 1930 can control whether the ablation catheter continues the pulsed electric field ablation output according to the ablation damage range in the tissue.

[0175] Specifically, the ablation catheter includes an optical sensor disposed between the electrodes. The ablation damage estimation part can estimate the ablation damage range in the tissue according to the optical signal detected by the optical sensor. Alternatively, the ablation catheter includes an ultrasonic sensor disposed between the electrodes. The ablation damage estimation part can estimate the ablation damage range in the tissue according to the ultrasonic imaging signal detected by the ultrasonic sensor.

[0176] In this case, the pulsed electric field ablation control device may further include an ablation depth determination part (not shown) for calculating the real-time ablation depth according to the ablation parameters and the real-time apposition pressure during the pulsed electric field ablation output. The ablation damage estimation part can also mutually correct the real-time damage detection result and the calculated real-time ablation depth to estimate the ablation damage range in the tissue.

[0177] The contact situation between the catheter (more specifically, the electrodes on the catheter) and the tissue can also be characterized by the apposition direction and positional relationship and the morphology of the ablation catheter.

[0178] The electrodes on the ablation catheter exemplified here are bipolar electrodes. The distance between different polarity electrodes is minimized. For example, Figures 4 to 7 in the shown electrode arrangement, the distances between the electrodes are all micro distances, and all can accurately map the electrophysiological signals of the head end in contact with the tissue and the local impedance between the head end electrode and the tissue.

[0179] Those skilled in the art should understand that each part of the pulsed electric field ablation control device according to the embodiments of the present application and the units included in each part can be regarded as functional modules, which can be implemented separately or as a whole through computer software, programs, and instructions, rather than necessarily being combined by physical or mechanical connections of each entity hardware.

[0180] Those of ordinary skill in the art should recognize that the methods involved in this application can be implemented as computer programs. As described above in conjunction with the accompanying drawings, the methods of the above embodiments are executed by one or more programs, including instructions to cause a computer or processor to execute the algorithms described in conjunction with the accompanying drawings. These programs can be stored using various types of non-transitory computer-readable media and provided to the computer or processor. Non-transitory computer-readable media include various types of tangible storage media. Examples of non-transitory computer-readable media include magnetic recording media (such as floppy disks, magnetic tapes, and hard disk drives), magneto-optical recording media (such as magneto-optical discs), CD-ROM (compact disc read-only memory), CD-R, CD-R / W, and semiconductor memories (such as ROM, PROM (programmable ROM), EPROM (erasable programmable PROM), flash ROM, and RAM (random access memory)). Further, these programs can be provided to the computer by using various types of transitory computer-readable media. Examples of transitory computer-readable media include electrical signals, optical signals, and electromagnetic waves. Transitory computer-readable media can be used to provide programs to the computer via wired communication paths such as wires and optical fibers or wireless communication paths.

[0181] For example, according to an embodiment of the present application, a non-transitory computer-readable storage medium can be proposed, on which a computer program is stored. The computer program includes instructions that, when executed by a processor of an electronic device, cause the electronic device to implement the pulsed electric field ablation control method as described above.

[0182] For example, according to an embodiment of the present application, a computer device can also be proposed. The computer device includes a processor, a memory, and a computer program. Among them, the computer program is stored in the memory and is configured to be executed by the processor. The computer program includes instructions for implementing the pulsed electric field ablation control method as described above.

[0183] The computer program or computing device can be combined with the pulsed electric field ablation consumables, thereby proposing a pulsed electric field ablation system. The pulsed electric field ablation system can include a pulsed electric field ablation catheter and a controller. The controller is used to execute the pulsed electric field ablation control method as described above according to computer instructions or implement the functions of each part of the pulsed electric field ablation control device as described above.

[0184] The embodiments of the present application are not limited to those described in the above embodiments. Without departing from the spirit and scope of the present application, those of ordinary skill in the art can make various changes and improvements in form and details, and all of these are considered to fall within the protection scope of the present application.

Claims

1. A pulse electric field ablation control device, comprising: The impedance detection part uses the electrodes on the ablation catheter to perform fine impedance detection on the contacted tissue; A tissue thickness determination part, which determines the thickness of the tissue according to the change of the detected impedance under different contact conditions; A tissue site determination section, which determines the site of the tissue that the electrode is contacting based on the electrophysiological signal collected by the electrode; an ablation control part, which controls the ablation catheter to output pulsed electric field ablation according to the location of the tissue and the determined thickness of the tissue, Characterized in that the contact condition includes abutment pressure, wherein: The impedance detection part is configured to collect impedance values ​​of the tissue under different contact pressure conditions, The tissue thickness determination part is configured to: plot the change characteristics of the collected impedance value as a curve, and compare it with multiple basic curves that reflect the change characteristics of impedance values ​​of different tissue thicknesses and are drawn and saved in advance through experimental data; when the change characteristic curve of the collected impedance value matches one of the multiple basic curves that reflect the change characteristics of impedance values ​​of different tissue thicknesses and are drawn and saved in advance through experimental data, the thickness of the tissue is determined as the tissue thickness reflected by the matched basic curve.

2. The device according to claim 1, characterized in that The ablation control section further includes an ablation parameter determination unit that determines an ablation parameter based on the location of the tissue and the determined thickness of the tissue.

3. The device according to claim 2, characterized in that The ablation parameters include: pulse discharge voltage, single effective discharge time, pulse width, and superposition times.

4. The device according to claim 1, characterized in that The collected impedance value is the difference between the real-time detected impedance value and the impedance value in the blood.

5. The device according to claim 1, characterized in that During the pulse electric field ablation output process, when the impedance detection part detects a sudden change in real-time impedance, the ablation control part is further configured to immediately stop the pulse electric field ablation output.

6. The device according to claim 1, characterized in that The ablation control section is further configured to control whether the ablation catheter continues to output pulsed electric field ablation according to a comparison result between the real-time ablation depth and the thickness of the tissue.

7. The device according to claim 6, characterized in that The device further comprises an ablation depth determination part, which calculates the real-time ablation depth according to the ablation parameters and the real-time contact pressure during the pulse electric field ablation output process.

8. The device according to claim 7, characterized in that The ablation depth determination part calculates the real-time ablation depth according to the following formula: ， Among them, PFADepth is the real-time ablation depth, V is the pulse discharge voltage, T is the single effective discharge time, u is the pulse width, n is the number of superpositions, CF is the real-time contact pressure, t is the time variable, and C, α, and β are correction coefficients.

9. The device according to claim 6, characterized in that The ablation control part is further configured to: when the real-time ablation depth is less than the thickness of the tissue, control the ablation catheter to continue pulsed electric field ablation output; when the real-time ablation depth is equal to the thickness of the tissue, control the ablation catheter to stop ablation.

10. The device according to claim 1, characterized in that The device further comprises an ablation lesion estimation section, which estimates the ablation lesion range in the tissue according to the real-time lesion detection result. The ablation control section is further configured to control whether the ablation catheter continues to output pulsed electric field ablation according to the ablation lesion range in the tissue.

11. The device according to claim 10, characterized in that The ablation catheter includes an optical sensor disposed between electrodes, and the ablation lesion estimation section is configured to estimate an ablation lesion range in the tissue according to an optical signal detected by the optical sensor.

12. The device according to claim 10, characterized in that The ablation catheter includes an ultrasonic sensor disposed between electrodes, and the ablation lesion estimation section is configured to estimate an ablation lesion range in the tissue according to an ultrasonic imaging signal detected by the ultrasonic sensor.

13. The device according to claim 10, characterized in that The device further includes an ablation depth determination part, which calculates the real-time ablation depth according to the ablation parameters and the real-time contact pressure during the pulse electric field ablation output process. The ablation damage estimation part is further configured to: correct the real-time damage detection result and the calculated real-time ablation depth to estimate the ablation damage range in the tissue.

14. The device according to claim 1, characterized in that The contact condition also includes the direction and position relationship of the abutment and the shape of the ablation catheter.

15. The device according to claim 1, characterized in that The electrodes on the ablation catheter are bipolar electrodes and the distance between electrodes of different polarities is minimized.

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