Pulsed field ablation control apparatus and method

Abstract

Disclosed in the present application are a pulsed field ablation control apparatus and method. The pulsed field ablation control apparatus comprises: an impedance measurement portion, which uses an electrode on an ablation catheter to perform fine impedance measurement on a contacting tissue; a tissue thickness determination portion, which determines the thickness of the tissue on the basis of changes in the measured impedance under different contact conditions; and an ablation control portion, which controls, on the basis of the determined thickness of the tissue, the ablation catheter to perform pulsed field ablation output. The electrode can be used to accurately measure the impedance of the contacting tissue and slight changes in the impedance under different contact conditions, and thus the thickness of the tissue can be calculated and appropriate ablation parameters can be matched, thereby avoiding complications caused by excessive ablation parameters. Moreover, a pulsed field ablation control technique can be used to determine an ablation depth and control the catheter, so as to avoid excessive ablation.

Description

Pulsed electric field ablation control device and method

[0001] Cross-citation of related applications

[0002] This application claims priority to Chinese Patent Application No. 202510142752.X, filed on February 10, 2025, entitled "Pulse Electric Field Ablation Control Device", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to the field of catheter mapping and ablation technology, and more specifically to a pulsed electric field ablation control device. Background Technology

[0004] Pulsed electric field technology applies a brief high voltage to tissue, generating a localized high electric field of hundreds of volts per centimeter. This localized high electric field disrupts the cell membrane by creating pores. When the applied electric field exceeds the cell's threshold, the pores fail to close, resulting in irreversible electroporation. This allows biomolecules to cross the membrane for exchange, leading to cell necrosis or apoptosis. Unlike physical therapies based on thermal ablation principles such as radiofrequency, cryotherapy, microwave, and ultrasound, pulsed irreversible electroporation ablation of the myocardial cell membrane is a non-thermal biological effect, effectively avoiding damage to blood vessels, nerves, and the esophagus. The high-frequency pulsed electric field, maintaining the non-thermal advantage of irreversible electroporation, holds promise for overcoming the challenges of cell membrane capacitance and the uneven internal electric field distribution caused by the anisotropy of biological tissues. In the application of bipolar pulses, if a positive pulse train is followed immediately by a negative pulse train with the same pulse width and field strength, the action potential induced by the positive pulse may not have enough time to be fully generated, and the negative pulse may cause the action potential to develop in the opposite direction, which will greatly reduce the effect of the electric field on nerve stimulation.

[0005] Pulsed electric field ablation has an extremely short duration, making precise control of the ablation depth impossible and posing a risk of over-ablation damage. Furthermore, because tissue thickness at the ablation site varies significantly depending on the location of the heart and individual differences, setting the ablation parameters too low may result in incomplete ablation, while setting them too high may lead to severe muscle tremors and excessive ablation damage. Based on these issues, to improve the success rate of pulsed electric field ablation and reduce ablation-related complications, a design is needed that can calculate and measure tissue thickness, recommend ablation parameters based on the location and tissue thickness, and calculate the ablation depth. Summary of the Invention

[0006] As can be seen from the above description, the current pulse ablation technology has the following problems:

[0007] 1. Pulse ablation discharge time is short, and multiple ablations are required to achieve the ideal ablation depth, making it impossible to clearly control the depth of damage caused by pulse ablation.

[0008] 2. There is a lack of effective methods for assessing tissue thickness at the ablation site.

[0009] To address the above issues, a pulsed electric field ablation control technology was designed. Based on precise electrophysiological signal mapping and impedance detection, this technology can predict the thickness of the tissue to be ablated, thereby controlling the pulsed electric field ablation output of the ablation catheter. The "control" referred to here includes determining ablation parameters, such as pulse discharge voltage, single effective discharge time, pulse width, and number of stacks, as well as safety monitoring, ablation depth calculation, and the initiation and termination of the ablation process.

[0010] According to a first aspect of this disclosure, a pulsed electric field ablation control method is provided. The pulsed electric field ablation control method may include: performing fine impedance detection on the contacting tissue using electrodes on an ablation catheter; determining the thickness of the tissue based on the detected impedance changes under different contact conditions; and controlling the ablation catheter to output a pulsed electric field ablation based on the determined tissue thickness.

[0011] Preferably, the control step may further include: determining ablation parameters based on the location of the tissue and the determined thickness of the tissue.

[0012] Preferably, the ablation parameters may include: pulse discharge voltage, single effective discharge time, pulse width, and number of stacks.

[0013] Preferably, the pulsed electric field ablation control method further includes: determining the location of the tissue being contacted by the electrode based on the electrophysiological signals collected by the electrode.

[0014] Preferably, the contact condition includes contact pressure. In the pulsed electric field ablation control method according to the first aspect of this disclosure, the impedance detection step may include: acquiring impedance values ​​for the tissue under different contact pressure conditions; the tissue thickness determination step may include: comparing the variation characteristics of the acquired impedance values ​​with the impedance value variation characteristics of different tissue thicknesses stored in advance, and matching them to obtain the thickness of the tissue.

[0015] Specifically, the impedance value variation characteristics collected can be plotted as a curve. The impedance value variation characteristics of different tissue thicknesses, which are pre-stored, can be multiple basic curves reflecting the impedance value variation characteristics of different tissue thicknesses, plotted and saved in advance based on experimental data. The step of matching to obtain the thickness of the tissue includes: when the impedance value variation characteristic curve collected matches one of the multiple basic curves reflecting the impedance value variation characteristics of different tissue thicknesses, plotted and saved in advance based on experimental data, the thickness of the tissue is determined as the tissue thickness reflected by the matched basic curve.

[0016] Preferably, the impedance value collected can be the difference between the real-time detected impedance value and the impedance value in the blood.

[0017] During the pulsed electric field ablation output process, when a real-time impedance change is detected, the control steps may further include: immediately stopping the pulsed electric field ablation output.

[0018] Preferably, the control step may further include: controlling whether the ablation catheter continues to output pulsed electric field ablation based on the comparison result between the real-time ablation depth and the thickness of the tissue.

[0019] Preferably, the pulsed electric field ablation control method may further include: during the pulsed electric field ablation output process, calculating the real-time ablation depth based on the ablation parameters and the real-time contact pressure.

[0020] The real-time ablation depth can be calculated using the following formula:

[0021] 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 number of stacks, CF is the real-time contact pressure, t is the time variable, and C, α, and β are correction coefficients.

[0022] The control steps may further include: when the real-time ablation depth is less than the thickness of the tissue, controlling the ablation catheter to continue pulsed electric field ablation output; when the real-time ablation depth is equal to the thickness of the tissue, controlling the ablation catheter to stop ablation.

[0023] Preferably, the pulsed electric field ablation control method may further include: estimating the ablation damage range in the tissue based on real-time damage detection results. Therefore, the control step may further include: controlling whether the ablation catheter continues to output pulsed electric field ablation based on the ablation damage range in the tissue.

[0024] Preferably, the ablation catheter includes an optical sensor disposed between the electrodes, then the ablation damage estimation step may include: estimating the extent of ablation damage in the tissue based on the light signal detected by the optical sensor.

[0025] Similarly, if the ablation catheter includes an ultrasound sensor disposed between electrodes, the ablation damage estimation step may include estimating the extent of ablation damage in the tissue based on ultrasound imaging signals detected by the ultrasound sensor.

[0026] Preferably, the pulsed electric field ablation control method may further include: calculating the real-time ablation depth based on ablation parameters and real-time contact pressure during the pulsed electric field ablation output process. The ablation damage estimation step may further include: mutually correcting the real-time damage detection result with the calculated real-time ablation depth to estimate the ablation damage range in the tissue.

[0027] Preferably, the contact conditions may further include the direction and position of contact, as well as the shape of the ablation catheter.

[0028] The electrodes on the ablation catheter can be bipolar electrodes with the distance between electrodes of different polarities minimized.

[0029] According to a second aspect of this disclosure, a pulsed electric field ablation control device is provided. The pulsed electric field ablation control device may include: an impedance detection section for performing fine impedance detection on the contacting tissue using electrodes on an ablation catheter; a tissue thickness determination section for determining the thickness of the tissue based on the detected impedance changes under different contact conditions; and an ablation control section for controlling the ablation catheter to output pulsed electric field ablation based on the determined tissue thickness.

[0030] Preferably, the ablation control section may further include an ablation parameter determination unit, which determines the ablation parameters based on the location of the tissue and the determined thickness of the tissue.

[0031] Preferably, the ablation parameters may include: pulse discharge voltage, single effective discharge time, pulse width, and number of stacks.

[0032] Preferably, the pulsed electric field ablation control device further includes a tissue site determination part, which determines the site of the tissue that the electrode is contacting based on the electrophysiological signals collected by the electrode.

[0033] Preferably, the contact condition includes contact pressure. In the pulsed electric field ablation control device according to the second aspect of this disclosure, the impedance detection part can be configured to: acquire impedance values ​​for the tissue under different contact pressure conditions; the tissue thickness determination part can be configured to: compare the variation characteristics of the acquired impedance values ​​with the impedance value variation characteristics of different tissue thicknesses stored in advance, and match them to obtain the thickness of the tissue.

[0034] Specifically, the impedance value variation characteristics collected can be plotted as a curve. The impedance value variation characteristics of different tissue thicknesses, which are pre-stored, can be multiple basic curves reflecting the impedance value variation characteristics of different tissue thicknesses, plotted and saved in advance based on experimental data. The matching to obtain the tissue thickness includes: when the impedance value variation characteristic curve collected matches one of the multiple basic curves reflecting the impedance value variation characteristics of different tissue thicknesses, plotted and saved in advance based on experimental data, the tissue thickness is determined as the tissue thickness reflected by the matched basic curve.

[0035] Preferably, the impedance value collected can be the difference between the real-time detected impedance value and the impedance value in the blood.

[0036] During the pulsed electric field ablation output process, when the impedance detection section detects a real-time impedance change, the ablation control section can be further configured to immediately stop the pulsed electric field ablation output.

[0037] Preferably, the ablation control section can be further configured to: control whether the ablation catheter continues to output pulsed electric field ablation based on the comparison result between the real-time ablation depth and the thickness of the tissue.

[0038] Preferably, the pulsed electric field ablation control device may further include an ablation depth determination part, which calculates the real-time ablation depth based on ablation parameters and real-time contact pressure during the pulsed electric field ablation output process.

[0039] The ablation depth determination part can be calculated based on the following formula:

[0040] 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 number of stacks, CF is the real-time contact pressure, t is the time variable, and C, α, and β are correction coefficients.

[0041] The ablation control section 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 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.

[0042] Preferably, the pulsed electric field ablation control device may further include an ablation damage estimation section, which estimates the ablation damage range in the tissue based on real-time damage detection results. Therefore, the ablation control section may be further configured to: control whether the ablation catheter continues to output pulsed electric field ablation based on 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 section can be configured to estimate the extent of ablation damage in the tissue based on the light signal detected by the optical sensor.

[0044] Similarly, the ablation catheter includes an ultrasound sensor disposed between electrodes, and the ablation damage estimation section can be configured to estimate the extent of ablation damage in the tissue based on ultrasound imaging signals detected by the ultrasound sensor.

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

[0046] Preferably, the contact conditions may further include the direction and position of contact, as well as the shape of the ablation catheter.

[0047] The electrodes on the ablation catheter can be bipolar electrodes with the distance between electrodes of different polarities minimized.

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

[0049] According to a fourth aspect of this disclosure, a pulsed electric field ablation system is provided. 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 this disclosure according to computer instructions.

[0050] In the example ablation catheter according to this disclosure, a focused electrode is used, thereby enabling precise detection of the impedance of the contact tissue and minute changes in impedance under different contact conditions. The pulsed electric field ablation control technology of this disclosure can calculate tissue thickness and match appropriate ablation parameters by accurately detecting impedance changes, avoiding complications caused by excessively large ablation parameters. Furthermore, using the pulsed electric field ablation control technology of this disclosure allows for determination of ablation depth and control of the catheter, preventing over-ablation. Attached Figure Description

[0051] This disclosure will be more fully understood through the following detailed description and in conjunction with the accompanying drawings, wherein similar elements are numbered in a similar manner, wherein:

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

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

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

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

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

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

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

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

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

[0061] Figure 10 is a schematic diagram of the electrode making slight contact with the tissue.

[0062] Figure 11 is a schematic diagram of the increased pressure on the tissue in contact with the electrode.

[0063] Figure 12 is a schematic diagram showing the impedance changes corresponding to different contact pressures.

[0064] Figure 13 shows the effects after different numbers of ablation cycles.

[0065] Figure 14 is a schematic diagram of abnormal impedance changes during the ablation process.

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

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

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

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

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

[0071] Figure Labels: 1 Ablation Electrode 2 Myocardial Tissue 221 Thick Myocardial Tissue 222 Thin Myocardial Tissue 3 Ablation Damage Range 41 First Ablation Electrode 42 Second Ablation Electrode 51 First Ablation Electrode 52 Second Ablation Electrode 53 Third Ablation Electrode 54 Fourth Ablation Electrode 61 Ablation Electrode 62 Microelectrode 71 Ablation Electrode 72 Tubular Electrode 8 Physiological Saline 9 Tube Body 10 Pressure Sensor 11 Optical Sensor 12 Ultrasonic Sensor 13 Plant Tissue 14 Traction Component 15 Magnetic Positioning Sensor 16 Magnetic Positioning Sensor 311 Damage Range After One Ablation 312 Damage Range After Three Ablations 313 Damage Range After Five Ablations 171 Elastomer 172 First Strain Sensor 173 Second Strain Sensor 174 Third Strain Sensor Detailed Implementation

[0072] The technical solutions of this disclosure will be further described in detail below through embodiments and in conjunction with the accompanying drawings, but the scope of this disclosure is not limited to the following embodiments.

[0073] Figure 1 is a schematic diagram of ablation of thick myocardial tissue. Figure 2 is a schematic diagram of ablation of thin myocardial tissue. Figure 3 is a schematic diagram of ablation of thick myocardial tissue under sufficient pressure.

[0074] As shown in Figures 1 to 3, when ablation electrode 1 is used under the same ablation parameters, the ablation damage range 3 is basically the same. However, the tissue 221 shown in Figure 1 is thicker and difficult to ablate through the wall; the tissue 222 shown in Figure 2 is thinner and can easily ablate through the wall and damage the surrounding tissue. Compared to Figure 1, Figure 3 can also ablate the thick myocardial tissue 221 through the wall when the contact pressure is sufficient. Figure 13 shows the effects after different ablation cycles. As shown in Figure 13, under the same parameters, the ablation depth on the plant tissue 13 is represented in the figure as the damage range 311 after one ablation, the damage range 312 after three ablation cycles, and the damage range 313 after five ablation cycles. It can be seen from Figure 13 that as the number of ablation cycles increases, the ablation depth, i.e., the damage range shown, also increases; therefore, the factors affecting the ablation damage through the wall are directly related to the contact pressure, tissue thickness, ablation parameters, and the number of stacking cycles.

[0075] In the example bipolar pulsed electric field ablation catheter, there are an even number of electrodes linearly distributed along the axial direction at the catheter tip. This design has the problem of not being able to precisely focus the ablation of the lesion site: the head electrode is in contact with the ablation site, and the 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 does not contact the tissue during discharge, but rather ablates in the blood; thus, some energy flows into the bloodstream, affecting the ablation efficiency; at the same time, excessive ablation in the blood may cause unnecessary damage to the red blood cells, leading to complications such as kidney failure.

[0076] To avoid the problem of non-focusing ablation, in a preferred embodiment of this disclosure, the ablation electrode design can be as shown in Figures 4 to 7.

[0077] As shown in Figure 4, in the first tip electrode arrangement of the bipolar pulsed electric field ablation catheter, the first ablation electrode 41 and the second ablation electrode 42 are located at the very tip of the catheter. During discharge ablation, 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 their electrode surface areas are equal. This area is the area where the catheter is in most direct contact with the tissue, allowing for sufficient application of ablation energy to the tissue. Figure 8 is a schematic diagram of the ablation damage caused by the tip electrode. As shown in Figure 8, the ablation electrode 1 ablates the myocardial tissue 2, and the ablation damage area 3 is hemispherical, with the ablation energy concentrated in the myocardial tissue 2. In addition, Figure 4 also shows the tube body 9 of the ablation catheter and the pressure sensor 10 inside the tube body, whose related functions will be described in more detail later.

[0078] As shown in Figure 5, in the second tip electrode arrangement of the bipolar pulsed electric field ablation catheter, the first ablation electrode 51, the second ablation electrode 52, the third ablation electrode 53, and the fourth ablation electrode 54 are uniformly and symmetrically distributed along the central axis of the catheter. The electrode surface areas of the first ablation electrode 51, the second ablation electrode 52, the third ablation electrode 53, and the fourth ablation electrode 54 are equal, the polarities of the ablation electrodes are opposite to each other, and the electrode spacing is 0.1-1 mm. The ablation damage area is concentrated at the tip of the catheter, achieving focused and precise ablation. In addition, Figure 5 also shows the tube body 9 of the ablation catheter.

[0079] As shown in Figure 6, in the third tip electrode arrangement of the bipolar pulsed electric field ablation catheter, the ablation electrode 61 is the main tip electrode, with a microelectrode 62 arranged at the top of the main tip electrode, and 3-6 microelectrodes 62 evenly arranged laterally. During ablation, the ablation electrode 61 and the microelectrodes 62 have opposite polarities. The surface area of ​​the ablation electrode 61 is equal to the sum of the surface areas of all the microelectrodes 62. The ablation electrode 61 and all the microelectrodes 62 are independently insulated from each other, with a minimum spacing of 0.10-1 mm. The ablation damage area is concentrated at the tip of the catheter, achieving focused and precise ablation. Figure 6 also shows the tube body 9 of the ablation catheter.

[0080] As shown in Figure 7, in the fourth tip electrode arrangement of the bipolar pulsed electric field ablation catheter, the ablation electrode 71 is the main tip electrode, and a tubular electrode 72 is disposed inside the main tip electrode. During ablation, the surface area of ​​the ablation electrode 71 is less than or equal to the inner surface area of ​​the tubular electrode 72. The ablation electrode 71 and the tubular electrode 72 have opposite polarities, and the minimum electrode spacing is 0.10-1.0 mm. The ablation damage area is concentrated at the tip of the catheter, achieving focused and precise ablation. During ablation, physiological saline 8 is continuously perfused inside the tubular electrode 72. The main tip electrode, i.e., the ablation electrode 71, directly contacts the tissue, forming a circuit with the tubular electrode 72 through tissue or blood and physiological saline 8. Since the tubular electrode 72 is constantly in contact with only physiological saline 8 inside, the impedance of the tissue in contact with the ablation electrode 71 can also provide feedback on a fine local impedance value. In addition, Figure 7 also shows the tube body 9 of the ablation catheter and the pressure sensor 10 inside the tube body, whose related functions will be described in more detail later.

[0081] In the electrode arrangements shown in Figures 4 to 7, the distance between the electrodes is micro-spacing, which can accurately measure the electrophysiological signals of the tissue in contact with the head tip, as well as the local impedance between the head tip electrode and the tissue.

[0082] Taking the method shown in Figure 4 as an example, the distance between ablation electrodes 41 and 42 is 0.40-1.30 mm. The smaller the electrode distance, the better the quality of the acquired electrophysiological signal, and the more accurate the determination of tissue location through electrophysiological signals. Since the electrode tip is in direct contact with the tissue, the electrode tip can directly acquire the impedance of ablation electrodes 41 and 42, and the acquired impedance value is accurate, avoiding the measurement inaccuracy problem caused by the rear electrode being suspended in the blood when the front electrode acquires impedance to the rear electrode in traditional methods. Based on precise electrophysiological signal mapping and precise impedance monitoring, tissue location determination and tissue thickness prediction are performed, thereby providing matching ablation parameters. The ablation depth can be calculated after knowing the contact pressure, ablation parameters, and number of stackings.

[0083] This disclosure presents a pulsed electric field ablation control method and apparatus. Specific embodiments of this disclosure are described below from the perspectives of both the method and the apparatus.

[0084] Control methods

[0085] As described above, based on precise electrophysiological signal mapping and detailed impedance monitoring, the tissue site to be ablated can be determined, and the tissue thickness can be predicted, thereby controlling the pulsed electric field ablation output of the ablation catheter. The "control" mentioned in this article includes determining ablation parameters, such as pulse discharge voltage, single effective discharge time, pulse width, and number of stacks, as well as safety monitoring, ablation depth calculation, and the initiation and termination of the ablation process.

[0086] Figure 9 is a flowchart of a pulsed electric field ablation control method according to an embodiment of the present disclosure.

[0087] As shown in Figure 9, the pulsed electric field ablation control method 900 according to an embodiment of the present disclosure begins at step S910, in which the contact tissue is subjected to fine impedance detection using electrodes on the ablation catheter.

[0088] In step S920, the thickness of the tissue is determined based on the detected changes in impedance under different contact conditions.

[0089] The contact described herein can also be referred to as contact or contact. Those skilled in the art will understand that, in the context of this disclosure, these two terms are used interchangeably and have the same meaning. The contact conditions in step S920 may include the contact pressure described above. In a preferred embodiment, step S910 may specifically include: acquiring impedance values ​​for the tissue under different contact pressure conditions. Accordingly, step S920 may specifically include: comparing the characteristics of the acquired impedance value changes with the impedance value change characteristics of different tissue thicknesses pre-stored to match and obtain the thickness of the tissue. Specifically, the characteristics of the acquired impedance value changes can be plotted as curves. The pre-stored impedance value change characteristics of different tissue thicknesses may be multiple base curves reflecting the impedance value change characteristics of different tissue thicknesses, pre-plotted and saved using experimental data. In other words, in the pre-stored base curves, each curve represents a tissue thickness. The matching described above to determine the tissue thickness is achieved as follows: when the characteristic curve of the acquired impedance value change matches one of multiple baseline curves reflecting the impedance value change characteristics of different tissue thicknesses, which are pre-plotted and saved based on experimental data, the tissue thickness is determined to be the tissue thickness reflected by the matched baseline curve. In a preferred embodiment, the acquired impedance value is actually the difference between the real-time detected impedance value and the impedance value in the blood.

[0090] Those skilled in the art will understand that, in some embodiments, the contact conditions described herein may also include the direction and position of contact, as well as the shape of the ablation catheter.

[0091] In step S930, the ablation catheter is controlled to output pulsed electric field ablation based on the determined thickness of the tissue.

[0092] The control described in step S930 may further include determining ablation parameters.

[0093] According to a preferred embodiment of this disclosure, the determination of ablation parameters requires identification of the site of the tissue to be ablated and determination of the thickness of the tissue. Therefore, in addition to step S920, the control method 900 may also need to include an additional step of determining the site of the tissue being contacted by the electrode based on the electrophysiological signals acquired by the electrode of the ablation catheter.

[0094] Here, ablation parameters can include: pulse discharge voltage, single effective discharge time, pulse width, and number of stacks. Of course, ablation parameters can also be narrowly defined as single-ablation parameters, that is, they do not include the number of stacks, but only include parameters for a single ablation, such as pulse discharge voltage, single effective discharge time, pulse width, etc.

[0095] During the pulsed electric field ablation output process, when a real-time impedance change is detected, step S930 may further include: immediately stopping the pulsed electric field ablation output to ensure the safety of the ablation.

[0096] Furthermore, as mentioned above, the "control" in step S930 also includes the calculation of the ablation depth. Specifically, in a preferred embodiment, during the pulsed electric field ablation output process, the real-time ablation depth is calculated based on ablation parameters (including pulse discharge voltage, single effective discharge time, pulse width, number of stacks, etc.) and real-time contact pressure. More detailed examples are given in the embodiments below.

[0097] Then, based on the comparison between the real-time ablation depth and the thickness of the tissue, the ablation catheter can be controlled to continue pulsed electric field ablation output. Specifically, when the real-time ablation depth is less than the thickness of the tissue, the ablation catheter is controlled to continue pulsed electric field ablation output. When the real-time ablation depth is equal to the thickness of the tissue, the ablation catheter is controlled to stop ablation.

[0098] As previously mentioned, the "control" in step S930 also includes safety monitoring. Specifically, the extent of ablation damage in the tissue can be estimated based on real-time damage detection results.

[0099] For example, an ablation catheter may include an optical sensor positioned between electrodes. Based on the light signals detected by the optical sensor, the extent of ablation damage in the tissue can be estimated.

[0100] Alternatively, the ablation catheter may include an ultrasound sensor positioned between the electrodes. The extent of ablation damage in the tissue is estimated based on ultrasound imaging signals detected by the ultrasound sensor.

[0101] The aforementioned real-time damage detection results, whether derived from optical or ultrasonic sensors, can be cross-corrected with the calculated real-time ablation depth, thereby more accurately estimating the ablation damage range in the tissue. As mentioned earlier, during the pulsed electric field ablation output process, the real-time ablation depth can be calculated based on the ablation parameters and real-time contact pressure.

[0102] Furthermore, based on the extent of ablation damage in the tissue, the ablation catheter is controlled to continue pulsed electric field ablation output.

[0103] As described above, since the method of this disclosure is based on the precise detection of tissue impedance, the preferred arrangement of the focusing electrodes has been given above, see Figures 4 to 7. Generally speaking, the electrodes on the ablation catheter can be bipolar electrodes and the distance between electrodes of different polarities needs to be minimized.

[0104] Implementation Method 1 - Determination of Tissue Location

[0105] The approximate location of the electrode can be determined by detecting electrophysiological signals. If the electrophysiological signal acquired by the electrode only shows an atrial waveform, it indicates the electrode is located within the atrium; if it only shows a ventricular waveform, it indicates the electrode is located within the ventricle; if both atrial and ventricular waveforms are acquired, the amplitude of the atrial and ventricular waveforms should be examined: if the amplitudes are the same, the electrode is located at the tricuspid or mitral valve annulus; if the atrial amplitude is large and the ventricular amplitude is small, the electrode is located near the valve annulus, slightly towards the atrium; if the atrial amplitude is small and the ventricular amplitude is large, the electrode is located near the valve annulus, slightly towards the ventricle. Based on the characteristics of the electrophysiological signals, the location of the catheter can be basically determined. Because the atrial wall is thinner and the ventricular wall is thicker, and ablation within the atrium is more likely to cause muscle tremors, different parameters are selected for different locations.

[0106] Implementation Method 2 - Determination of Tissue Thickness

[0107] As shown in Figure 10, when electrodes 41 and 42 are in slight contact with tissue 2, i.e., when the contact pressure is low, the contact area between the electrodes and the tissue is small, while the electrodes are in most contact with the blood. Because the impedance of the tissue is higher than that of the blood, the impedance value collected by the electrodes at this time is relatively small.

[0108] As shown in Figure 11, when the pressure of electrodes 41 and 42 in contact with tissue 2 increases, i.e., when the contact pressure increases, the contact area between the electrodes and the tissue increases, while the contact area between the electrodes and the blood decreases. Because the impedance of the tissue is higher than that of the blood, the impedance value collected by the electrodes increases relatively more at this time.

[0109] Figure 12 is a schematic diagram showing the impedance changes corresponding to different contact pressures. As shown in Figure 12, based on the impedance detection characteristics described above, for the same tissue under different pressure conditions, the impedance value ΔR (ΔR is the difference between the real-time impedance value and the impedance value in the blood) acquired by the electrode will increase accordingly. This characteristic is plotted as a curve, namely the T1, T2, or T3 curves in the figure. For different myocardial tissues, such as the atria and ventricles, the change curves will differ, so the tissue thickness represented by T1, T2, and T3 increases sequentially. For example, as shown in Figure 12, the T1 to T3 curves are three basic curves reflecting the impedance value change characteristics of three different tissue thicknesses, pre-plotted and saved based on experimental data. In other words, each curve in the pre-stored basic curves represents a tissue thickness. In clinical practice, the change curves of ΔR and pressure F are detected by contacting the electrode with the tissue (plotted based on the detection results). The detected curves are then matched with the basic curves to calculate the tissue thickness. In other words, when the detected curve matches one of the multiple base curves that reflect the impedance value changes of different tissue thicknesses and are pre-plotted and saved based on experimental data, the thickness of the tissue is determined to be the tissue thickness reflected by the matched base curve.

[0110] Implementation Method 3 - Selection of Ablation Parameters

[0111] The ablation parameters are determined by combining the tissue location identified in Implementation 1 with the tissue thickness determined in Implementation 2.

[0112] In a preferred embodiment, the ablation parameters can be expressed as:

[0113] Prameter(V,T,u,n)

[0114] 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 stacks. In other words, in this preferred embodiment, the ablation parameters include the pulse discharge voltage, the single effective discharge time, the pulse width, and the number of stacks.

[0115] Implementation Method 4 - Safety Monitoring

[0116] Safety monitoring can be performed during the ablation process. Because the electrode detection impedance is very precise and sensitive, as shown in Figure 14, if the local impedance between the detection electrodes suddenly increases during the discharge process, that is, an impedance abrupt change occurs, it indicates that a large microbubble has been generated, and the feedback control system will immediately stop the ablation.

[0117] Implementation Method 5 - Calculating Real-Time Ablation Depth

[0118] During the pulsed electric field ablation output process, the real-time ablation depth is calculated based on the ablation parameters and the real-time contact pressure. The real-time ablation depth can be calculated using the following formula:

[0119] 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 number of stacks, CF is the real-time contact pressure, t is the time variable, and C, α, and β are correction coefficients.

[0120] Implementation Method 6 - Stop Ablation

[0121] The ablation depth is calculated in real time during the ablation process, and the calculated real-time ablation depth is compared with the tissue thickness collected before ablation. If the real-time ablation depth is less than the tissue thickness, ablation continues until the ablation depth reaches the tissue thickness.

[0122] More generally, the decision to stop ablation is based on the current damage assessment. That is, if the current damage assessment shows that the damage extent has reached the target, for example, the damage extent reaches the tissue thickness in at least one dimension (i.e., the ablation depth), then ablation can be stopped. Conversely, if the current damage assessment shows that the damage extent has not reached the target, for example, the damage extent has not penetrated the tissue thickness, then ablation can continue.

[0123] Damage assessment can also be obtained through the following methods.

[0124] Figure 15 shows the ablation head with an optical sensor. As shown in Figure 15, the optical sensor 11 is positioned between ablation electrodes 41 and 42 to detect the real-time damage depth of the ablated tissue. The detection principle is as follows: light is scattered within the tissue, and the analysis of the internal tissue structure is based on the principle of coherent optical interferometry. In low-coherence optical interferometry, light is split and propagates in two directions. Light reflected or scattered from the target along one path merges or interferes with light reflected from another known reference path. This interference signal is collected in a photodetector, analyzed to determine the tissue structure, and thus distinguishes between damaged and non-damaged areas. The optically detected ablation damage range can be mutually corrected with the ablation depth calculated in Embodiment 5, making the damage assessment more accurate and comprehensive.

[0125] Figure 16 shows the ablation head with an ultrasonic sensor. As shown in Figure 16, the ultrasonic sensor 12 is positioned between ablation electrodes 41 and 42 to detect the real-time damage depth of the ablated tissue. The principle of ultrasonic imaging is that different echoes generated by the differences in acoustic impedance and attenuation of different tissues constitute an image. By comparing the images, the boundary between damaged and normal tissues is distinguished, thereby determining the damage depth range. The ultrasonic detection of the ablation damage range can be mutually corrected with the ablation depth calculated in Implementation Method 5, making the damage assessment more accurate and comprehensive.

[0126] Implementation Method 7 - Contact (Penetration) Situation

[0127] According to the concept of this disclosure, the contact conditions include not only the contact pressure, but also the direction and positional relationship of the contact, as well as the shape of the ablation catheter. These contact conditions can be measured or evaluated using positioning sensors, pressure sensors, etc.

[0128] Figure 17 shows an example of the distribution of positioning sensors in an ablation catheter. As shown in Figure 17, a traction member 14 is provided at the end of the catheter. The entire traction device is located at one end of the catheter tip and at the proximal handle assembly. The traction member 14, as a component of the traction device, is located inside the catheter bending direction. The traction member 14 is positioned away from the catheter axis. The bending plane of the catheter is perpendicular to the line connecting the electrodes, i.e., the center between the two electrodes is the bending direction point, used to indicate the bending direction. Magnetic positioning sensors 15 and 16 are respectively located at the distal and proximal ends of the distal tube body, used to calculate and display the bending shape of the distal tube body. Magnetic positioning sensor 15 consists of two magnetic positioning sensors forming a certain angle, 5-20°, used to cooperate with the pressure sensor to provide feedback on the catheter's contact direction.

[0129] 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 shown in the upper part of Figure 18, a pressure sensor 10 is installed inside the catheter tip. As shown in the lower part of Figure 18, the pressure sensor 10 includes an elastic body 171 and a first strain sensor 172, a second strain sensor 173, and a third strain sensor 174 symmetrically arranged on the elastic body 171. Preferably, there are three or more strain sensors. It is preferable to set three strain sensors with an angle of 120° between them, and the zero point position (the center point between the electrodes) is aligned with the first strain sensor 172. This method links the contact position determined by the pressure sensor with the positional relationship determined by the magnetic positioning sensor. The X-axis component force Fx, Y-axis component force Fy, and Z-axis component force Fz are all pre-calibrated data and are known data. The positional relationship of Fx, Fy, and Fz relative to the zero point is known. The angle between the lateral component force (F side) and Fx is ∠b, which can be calculated. Then, since the relationship between Fx and the zero point position is known, the angular relationship of ∠b at the zero point position can be calculated. By using ∠a = arctan(Fz / Fside), the angle between the direction of the resultant force (Fresultant) and the lateral force can be determined, thus indirectly calculating the relationship between the direction of the resultant force and the zero point position. By calculating ∠a and ∠b, the direction of contact between the catheter and the tissue (relative to the zero point position) can be determined. The relationship between the zero point position and the position of the adjustable bend in the catheter body is known from the above. Combining these, the contact direction and positional relationship between the catheter tip and the tissue, as well as the morphology of the catheter, can be determined.

[0130] Control device

[0131] Figure 19 is a schematic block diagram of a pulsed electric field ablation control device and ablation catheter according to an embodiment of the present disclosure.

[0132] As shown in FIG19, the pulsed electric field ablation control device 1900 according to an embodiment of the present disclosure includes an impedance detection section 1910, a tissue thickness determination section 1920, and an ablation control section 1930. Those skilled in the art should understand that the impedance detection section 1910, the tissue thickness determination section 1920, and the ablation control section 1930 can respectively perform operations corresponding to steps S910, S920, and S930 in the method 900 of FIG9.

[0133] Specifically, the impedance detection section 1910 uses electrodes on the ablation catheter to perform fine impedance detection on the contacting tissue. The arrows in Figure 19 from the ablation catheter to the impedance detection section 1910 indicate that the electrophysiological signals measured by the electrodes through the catheter are sent to the impedance detection section 1910 for fine impedance detection. The tissue thickness determination section 1920 determines the thickness of the tissue based on the changes in impedance detected by the impedance detection section 1910 under different contact conditions. The ablation control section 1930 controls the ablation catheter to output pulsed electric field ablation based on the tissue thickness determined by the tissue thickness determination section 1920. The arrows in Figure 19 from the ablation control section 1930 to the ablation catheter indicate that the ablation control section 1930 controls the ablation output of the ablation catheter.

[0134] The ablation control unit 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: pulse discharge voltage, single effective discharge time, pulse width, and number of stacks. In a preferred embodiment, the pulsed electric field ablation control device 1900 may further include a tissue location determination unit (not shown) for determining the location of the tissue being contacted by the electrode based on the electrophysiological signals acquired by the electrode.

[0135] The contact between the catheter (more specifically, the electrodes on the catheter) and the tissue can be characterized by the contact pressure. The impedance detection section 1910 can acquire impedance values ​​for the tissue under different contact pressure conditions. Correspondingly, the tissue thickness determination section 1920 can compare the acquired impedance value variation characteristics with pre-stored impedance value variation characteristics for different tissue thicknesses to determine the tissue thickness. Specifically, the acquired impedance value variation characteristics are plotted as curves, and the pre-stored impedance value variation characteristics for different tissue thicknesses are multiple baseline curves reflecting impedance value variation characteristics for different tissue thicknesses, pre-plotted and saved using experimental data. When the acquired impedance value variation characteristic curve matches one of the pre-stored baseline curves reflecting impedance value variation characteristics for different tissue thicknesses, the tissue thickness is determined to be the tissue thickness reflected by the matched baseline curve. Preferably, the acquired impedance value is the difference between the real-time detected impedance value and the impedance value in the blood.

[0136] During the pulsed electric field ablation output process, when the impedance detection section 1910 detects a real-time impedance change, the ablation control section 1930 can immediately stop the pulsed electric field ablation output.

[0137] The ablation control unit 1930 can also control whether the ablation catheter continues to output pulsed electric field ablation based on the comparison 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 unit (not shown) for calculating the real-time ablation depth based on ablation parameters and real-time contact pressure during the pulsed electric field ablation output process. In a preferred embodiment, the ablation depth determination unit calculates the real-time ablation depth according to the following formula:

[0138] 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 number of stacks, CF is the real-time contact pressure, t is the time variable, and C, α, and β are correction coefficients.

[0139] The ablation control unit 1930 can control the ablation catheter to continue 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.

[0140] The pulsed electric field ablation control device may also include an ablation damage estimation section (not shown) for estimating the extent of ablation damage in the tissue based on real-time damage detection results. In this case, the ablation control section 1930 can control whether the ablation catheter continues to output pulsed electric field ablation based on the extent of ablation damage in the tissue.

[0141] Specifically, the ablation catheter includes an optical sensor disposed between the electrodes. An ablation damage estimation section can estimate the extent of ablation damage in the tissue based on the light signals detected by the optical sensor. Alternatively, the ablation catheter includes an ultrasound sensor disposed between the electrodes. An ablation damage estimation section can estimate the extent of ablation damage in the tissue based on the ultrasound imaging signals detected by the ultrasound sensor.

[0142] In this case, the pulsed electric field ablation control device may further include an ablation depth determination section (not shown), used to calculate the real-time ablation depth based on ablation parameters and real-time contact pressure during the pulsed electric field ablation output process. The ablation damage estimation section may also mutually correct the real-time damage detection results with the calculated real-time ablation depth to estimate the ablation damage range in the tissue.

[0143] The contact between the catheter (more specifically, the electrode on the catheter) and the tissue can also be characterized by the direction and position of contact, as well as the morphology of the ablation catheter.

[0144] The electrodes on the ablation catheter illustrated here are bipolar electrodes. The distance between electrodes of different polarities is minimized. For example, in the electrode arrangements shown in Figures 4 to 7, the distance between the electrodes is micro-spacing, which allows for precise measurement of the electrophysiological signals of the tissue in contact with the tip, as well as the local impedance between the tip electrode and the tissue.

[0145] Those skilled in the art should understand that each part and each unit included in the pulse electric field ablation control device according to the embodiments of this disclosure can be regarded as a functional module, which can be implemented separately or as a whole by computer software, programs, and instructions, and is not necessarily composed of various physical hardware components combined by physical or mechanical connections.

[0146] Those skilled in the art will recognize that the methods disclosed herein can be implemented as computer programs. As described above in conjunction with the accompanying drawings, performing the methods of the above embodiments by one or more programs includes instructions to cause a computer or processor to execute the algorithms described in conjunction with the drawings. These programs can be stored and provided to a computer or processor using various types of non-transitory computer-readable media. 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 disks), CD-ROMs (Compact Disc Read-Only Memory), CD-Rs, CD-R / Ws, and semiconductor memories (such as ROMs, PROMs (Programmable ROMs), EPROMs (Erasable and Writable PROMs), flash memory ROMs, and RAMs (Random Access Memory)). Furthermore, these programs can be provided to a computer using various types of transient computer-readable media. Examples of transient computer-readable media include electrical signals, optical signals, and electromagnetic waves. Transient computer-readable media can be used to provide programs to a computer via wired or wireless communication paths such as wires and optical fibers.

[0147] For example, according to one embodiment of this disclosure, a non-transient computer-readable storage medium may be proposed, on which a computer program is stored, the computer program including 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.

[0148] For example, according to one embodiment of this disclosure, a computer device may also be proposed, the computer device including a processor, a memory, and a computer program. The computer program is stored in the memory and configured to be executed by the processor. The computer program includes instructions for implementing the pulsed electric field ablation control method as described above.

[0149] A pulsed electric field ablation system can be proposed by combining a computer program or computing device with pulsed electric field ablation consumables. The pulsed electric field ablation system may 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 or to implement the functions of various parts of the pulsed electric field ablation control device as described above, according to computer instructions.

[0150] The embodiments described herein are not limited to those described above. Without departing from the spirit and scope of this disclosure, those skilled in the art can make various changes and improvements to the examples of this disclosure in form and detail, and all of these are considered to fall within the protection scope defined by this disclosure.

Claims

1. A pulsed electric field ablation control method, comprising: Fine impedance testing of the contacted tissue is performed using electrodes on the ablation catheter; The thickness of the tissue is determined based on the detected changes in impedance under different contact conditions; Based on the determined thickness of the tissue, the ablation catheter is controlled to output pulsed electric field ablation.

2. The method according to claim 1, further comprising: The ablation parameters are determined based on the location of the tissue and the determined thickness of the tissue.

3. The method of claim 3, wherein, The ablation parameters include: pulse discharge voltage, single effective discharge time, pulse width, and number of stacks.

4. The method of claim 2, further comprising: The location of the tissue that the electrode is contacting is determined based on the electrophysiological signals collected by the electrode.

5. The method according to claim 1, wherein, The contact conditions include contact pressure, and The impedance detection step includes: acquiring impedance values ​​for the tissue under different contact pressure conditions; The tissue thickness determination step includes: comparing the impedance value change characteristics collected with the impedance value change characteristics of different tissue thicknesses stored in advance, and matching them to obtain the thickness of the tissue.

6. The method of claim 5, wherein, The characteristics of the collected impedance values ​​were plotted as curves. The pre-stored impedance value variation characteristics for different tissue thicknesses were multiple baseline curves reflecting the impedance value variation characteristics of different tissue thicknesses, pre-plotted and saved using experimental data. The step of matching to obtain the thickness of the tissue includes: when the characteristic curve of the change of the acquired impedance value matches one of the multiple basic curves reflecting the characteristics of impedance value changes of different tissue thicknesses that have been plotted and saved in advance based on experimental data, the thickness of the tissue is determined as the tissue thickness reflected by the matched basic curve.

7. The method of claim 5, wherein, The impedance value collected is the difference between the real-time detected impedance value and the impedance value in the blood.

8. The method of claim 1, wherein, During the pulsed electric field ablation output process, when a real-time impedance change is detected, the control steps further include: immediately stopping the pulsed electric field ablation output.

9. The method of claim 1, wherein, The control steps further include: controlling whether the ablation catheter continues to output pulsed electric field ablation based on the comparison result between the real-time ablation depth and the thickness of the tissue.

10. The method of claim 9, further comprising: During the pulsed electric field ablation output process, the real-time ablation depth is calculated based on the ablation parameters and the real-time contact pressure.

11. The method of claim 10, wherein, The real-time ablation depth is calculated according to the following equation: 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 number of stacks, CF is the real-time contact pressure, t is the time variable, and C, α, and β are correction coefficients.

12. The method of claim 9, wherein, The control steps further include: When the real-time ablation depth is less than the thickness of the tissue, the ablation catheter is controlled to continue pulsed electric field ablation output; When the real-time ablation depth equals the thickness of the tissue, the ablation catheter is controlled to stop ablation.

13. The method of claim 1, further comprising: Based on the real-time damage detection results, the extent of ablation damage in the tissue is estimated. The control steps further include: controlling whether the ablation catheter continues to output pulsed electric field ablation based on the ablation damage range in the tissue.

14. The method of claim 13, wherein, The ablation catheter includes an optical sensor disposed between electrodes, and the ablation damage estimation step includes estimating the extent of ablation damage in the tissue based on the light signal detected by the optical sensor.

15. The method of claim 13, wherein, The ablation catheter includes an ultrasound sensor disposed between electrodes, and the ablation damage estimation step includes estimating the extent of ablation damage in the tissue based on the ultrasound imaging signal detected by the ultrasound sensor.

16. The method of claim 13, further comprising: During the pulsed electric field ablation output process, the real-time ablation depth is calculated based on the ablation parameters and real-time contact pressure. The ablation damage estimation step further includes: mutually correcting the real-time damage detection result with the calculated real-time ablation depth to estimate the ablation damage range in the tissue.

17. The method of claim 1, wherein, The contact details also include the direction and position of contact, as well as the shape of the ablation catheter.

18. The method of claim 1, wherein, The electrodes on the ablation catheter are bipolar electrodes with minimized distance between electrodes of different polarities.

19. A pulsed electric field ablation control device, comprising: In the impedance detection section, electrodes on the ablation catheter are used to perform fine impedance detection on the contacting tissue; The tissue thickness determination section determines the tissue thickness based on the detected changes in impedance under different contact conditions; The ablation control section controls the ablation catheter to output pulsed electric field ablation based on the determined thickness of the tissue.

20. The apparatus of claim 19, wherein, The ablation control section further includes an ablation parameter determination unit, which determines ablation parameters based on the location of the tissue and the determined thickness of the tissue.

21. The apparatus of claim 20, wherein, The ablation parameters include: pulse discharge voltage, single effective discharge time, pulse width, and number of stacks.

22. The apparatus of claim 20, further comprising: The tissue location determination section determines the location of the tissue that the electrode is contacting based on the electrophysiological signals collected by the electrode.

23. The apparatus according to claim 19, wherein, The contact conditions include contact pressure. The impedance detection section is configured to acquire impedance values ​​for the tissue under different contact pressure conditions. The tissue thickness determination section is configured to compare the impedance value change characteristics collected with the impedance value change characteristics of different tissue thicknesses stored in the pre-stored database, and match them to obtain the thickness of the tissue.

24. The apparatus of claim 23, wherein, The characteristics of the impedance value changes collected were plotted as curves. The pre-stored impedance value changes for different tissue thicknesses were multiple basic curves reflecting the impedance value changes for different tissue thicknesses, pre-plotted and saved using experimental data. The matching to obtain the thickness of the tissue includes: when the characteristic curve of the change of the acquired impedance value matches one of the multiple basic curves reflecting the characteristics of impedance value changes of different tissue thicknesses that have been plotted and saved in advance based on experimental data, the thickness of the tissue is determined to be the tissue thickness reflected by the matched basic curve.

25. The apparatus of claim 23, wherein, The impedance value collected is the difference between the real-time detected impedance value and the impedance value in the blood.

26. The apparatus of claim 19, wherein, During the pulsed electric field ablation output process, when the impedance detection section detects a real-time impedance change, the ablation control section is further configured to immediately stop the pulsed electric field ablation output.

27. The apparatus of claim 19, wherein, The ablation control section is further configured to control whether the ablation catheter continues to output pulsed electric field ablation based on the comparison result between the real-time ablation depth and the thickness of the tissue.

28. The apparatus of claim 27, further comprising: In the ablation depth determination section, the real-time ablation depth is calculated based on the ablation parameters and the real-time contact pressure during the pulsed electric field ablation output process.

29. The apparatus of claim 28, wherein, The ablation depth determination portion calculates the real-time ablation depth according to the following formula: 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 number of stacks, CF is the real-time contact pressure, t is the time variable, and C, α, and β are correction coefficients.

30. The apparatus of claim 27, wherein, The ablation control section 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.

31. The apparatus of claim 19, further comprising: The ablation damage estimation section estimates the extent of ablation damage in the tissue based on real-time damage detection results. The ablation control section is further configured to control whether the ablation catheter continues to output pulsed electric field ablation based on the ablation damage range in the tissue.

32. The apparatus of claim 31, wherein, The ablation catheter includes an optical sensor disposed between electrodes, and the ablation damage estimation section is configured to estimate the extent of ablation damage in the tissue based on the light signal detected by the optical sensor.

33. The apparatus of claim 31, wherein, The ablation catheter includes an ultrasound sensor disposed between electrodes, and the ablation damage estimation section is configured to estimate the extent of ablation damage in the tissue based on ultrasound imaging signals detected by the ultrasound sensor.

34. The apparatus of claim 31, further comprising: In the section on determining the ablation depth, during the pulsed electric field ablation output process, the real-time ablation depth is calculated based on the ablation parameters and the real-time contact pressure. The ablation damage estimation part is further configured to: mutually correct the real-time damage detection result and the calculated real-time ablation depth to estimate the ablation damage range in the tissue.

35. The apparatus of claim 19, wherein, The contact details also include the direction and position of contact, as well as the shape of the ablation catheter.

36. The apparatus of claim 19, wherein, The electrodes on the ablation catheter are bipolar electrodes with the distance between electrodes of different polarities minimized.

37. A non-transient computer-readable storage medium for storing a computer program, the computer program including 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 in any one of claims 1-18.

38. A pulsed electric field ablation system, comprising a pulsed electric field ablation catheter and a controller, the controller being configured to execute the pulsed electric field ablation control method as described in any one of claims 1-18 according to computer instructions.

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