A pulsed ablation system

Abstract

The present application relates to the technical field of medical pulse ablation, in particular to a pulse ablation system. The system comprises a catheter positioning device, a pulse generating device, a data processing system, a data acquisition device, a positioning box and a catheter, and the catheter is provided with electrodes with high-voltage pulse output and positioning functions; the positioning box is internally provided with a pulse channel, through which the high-voltage pulses output by the pulse generating device are output to one or more electrodes of the catheter; the positioning box is also internally provided with a positioning channel, through which impedance information and / or magnetic signals used for calculating the positions of the electrodes are output to the data acquisition device; the data processing system sets the pulse generating device according to the interval of the electrodes to be discharged with high-voltage pulses and obtains the discharge parameters of the pulse generating device, and also sets the pulse discharge mode according to the properties of the electrodes. The one-to-one, one-to-many or many-to-many electrode energy release between the catheters is realized, and the precise positioning of the high-voltage pulse energy release is facilitated.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical pulse ablation, in particular to a pulse ablation system. BACKGROUND

[0002] Nanosecond-level pulse high voltage is applied to the tissue, and a strong electric field is generated locally, which can cause cell membrane electroporation. If the micro-hole can be closed after the external electric field is removed, it is called reversible electroporation (RE). If the micro-hole cannot be self-repaired, it is called irreversible electroporation (IRE). Irreversible electroporation eventually leads to cell apoptosis. Electroporation ablation has selectivity, and different tissue cells have different threshold voltages for irreversible electroporation. Different threshold voltages, different pulse widths and different pulse effective times eventually result in different ranges of irreversible electroporation of the tissue. Because electroporation ablation has selectivity, while realizing irreversible electroporation of lesion tissue cells, healthy tissue can be well protected.

[0003] In the prior art, although the principle of high-voltage pulse can realize the perforation of myocardial cells, due to the structure and shape of the heart, the range of the electrode action cannot be accurately discharged to the position to be processed by using a single ring-shaped catheter or a linear catheter for high-voltage pulse output. For example, when the thickness between the endocardium and the epicardium is thick, it is difficult to realize transmural ablation by using multiple electrodes on the same catheter due to the limited area of the electrode high-voltage pulse radiation. SUMMARY

[0004] Based on the theory of pulse ablation, the present application carries out specific application research, realizes one-to-one, one-to-many and many-to-many electrode discharge of a single catheter electrode, and one-to-one, one-to-many and many-to-many electrode discharge between two catheters, and proposes a pulse ablation system.

[0005] In order to achieve the above-mentioned application purpose, the present application provides the following technical scheme:

[0006] A pulse ablation system comprises a catheter positioning device and a pulse generating device, and further comprises a data processing system, a data acquisition device, a positioning box and a catheter,

[0007] The catheter is provided with an electrode having high-voltage pulse output function and positioning function at the same time;

[0008] The positioning box is internally provided with a pulse channel, through which the high-voltage pulse output by the pulse generating device is output to the electrode of the catheter. The positioning box is also internally provided with a positioning channel, through which impedance information and / or magnetic signals used for calculating the position of the electrode are output to the data acquisition device;

[0009] The data processing system obtains the distance between the electrodes from which the high-voltage pulse is to be discharged according to the impedance information and / or magnetic signal, and sets the discharge parameters of the pulse generating device, and the data processing system also sets the pulse discharge mode according to the electrode properties.

[0010] As a preferred scheme of the present application, the pulse discharge mode in which the high-voltage pulse is output to the electrodes on the catheter includes discharge between one positive electrode and one negative electrode, discharge between one positive electrode and multiple negative electrodes, discharge between multiple positive electrodes and one negative electrode, and discharge between multiple positive electrodes and multiple negative electrodes.

[0011] As a preferred scheme of the present application, the pulse discharge mode includes discharge between one positive electrode and one negative electrode, discharge between one positive electrode and multiple negative electrodes, discharge between multiple positive electrodes and one negative electrode, and discharge between multiple positive electrodes and multiple negative electrodes on the same catheter, and discharge between one positive electrode and one negative electrode, discharge between one positive electrode and multiple negative electrodes, discharge between multiple positive electrodes and one negative electrode, and discharge between multiple positive electrodes and multiple negative electrodes between two catheters.

[0012] As a preferred scheme of the present application, the catheter includes a ring-shaped catheter and a linear catheter.

[0013] As a preferred scheme of the present application, the discharge parameters include pulse waveform, pulse voltage, pulse width, pulse distance, pulse group number, and pulse group distance.

[0014] As a preferred scheme of the present application, the pulse width and the pulse voltage determine the myocardial cell membrane perforation state, and the myocardial cell membrane perforation state includes irreversible perforation, reversible perforation, and non-electric perforation.

[0015] As a preferred scheme of the present application, the critical value of the irreversible perforation state and the reversible perforation state of the myocardial cell membrane is 400 V / cm.

[0016] As a preferred scheme of the present application, the electrode properties include electrode width and electrode ring radius.

[0017] As a preferred scheme of the present application, the data processing system is also used to establish a model of endocardium and epicardium according to the impedance information and / or magnetic signal, and directly measure the thickness between the endocardium and the epicardium from the model of the endocardium and the epicardium.

[0018] As a preferred scheme of the present application, the data processing system is also used to calculate the thickness between the endocardium and the epicardium according to the position information of the electrode on the catheter located inside the endocardium and the position information of the electrode on the catheter located outside the epicardium.

[0019] Based on the same concept, an impulse ablation platform is also proposed, comprising any one of the above-mentioned impulse ablation systems, and further comprising a graphical user interface of the data processing system, the graphical user interface comprising a control area, a catheter state display area and a program selection area,

[0020] The control area comprises a pulse emission mode setting button diagram, a pulse emission start button diagram and a pulse emission stop button diagram.

[0021] The catheter state display area displays the state of the electrodes on the catheter through a color diagram, and the state of the electrodes includes: positive electrode, negative electrode and unselected electrode.

[0022] The program selection area sets a plurality of buttons, and the buttons correspond to the preset high-voltage pulse emission parameters.

[0023] As a preferred scheme of the present application, the graphical user interface further comprises an area for displaying the distance between electrodes, and the distance between electrodes is displayed by numbers.

[0024] Compared with the prior art, the present application has the following beneficial effects:

[0025] 1. The present application relates to an impulse ablation system, comprising a catheter positioning device, a pulse generating device, a data processing system, a data acquisition device, a positioning box and a catheter, wherein the catheter has electrodes with high-voltage pulse output and positioning functions, and the positioning box has a high-voltage pulse output channel and a positioning channel for acquiring electrode position information, so that the data processing system can be used to set the emission parameters of high-voltage pulses according to the distance between electrodes, and set the pulse emission mode according to the electrode properties, so as to realize one-to-one, one-to-many or many-to-many electrode energy release between one catheter or two catheters, and facilitate precise positioning of high-voltage pulse energy release.

[0026] 2. The system solves the optimal preset emission mode (one-to-one, one-to-many or many-to-many) of impulse ablation according to the current electrode distance and known electrode properties (mainly electrode width and electrode ring radius), and adjusts the preset value range of the emission parameters (pulse waveform, pulse voltage, pulse width, pulse distance, pulse group number and pulse group distance) in the pulse generating device, so that the emission mode and parameter setting of high-voltage pulses are flexible and optional, providing multiple modes for pulse ablation of the catheter in the heart, and being more adaptable to pulse ablation of the heart, realizing combined ablation of intracardiac catheter and epicardial catheter, applying more energy to the tissue while ensuring that no bubbles are generated during the ablation process, and increasing the lesion damage depth.

[0027] 3、Particularly, it is clear that the myocardial cell membrane perforation state is determined according to the pulse width and the pulse voltage, the myocardial cell membrane perforation state includes irreversible perforation, reversible perforation and non-electroporation, before the high-voltage pulse energy output, according to the existing region division and the required perforation state to be reached, the pulse width and the pulse voltage can be determined correspondingly, the pre-judgment can be realized in advance, instead of determining the state after the high-voltage pulse energy output.

[0028] 4、The system can not only obtain the position information of the catheter electrode, but also can establish the model of the endocardium and the epicardium and calculate the thickness between the endocardium and the epicardium according to the position information.

[0029] 5、Based on the same concept, the application also provides a graphical user interface, which can intuitively feed back the catheter electrode pairing condition and the parameter setting condition, and can also display the spacing between the electrodes, so that the parameter setting can be carried out according to the spacing, and the staff can operate and use conveniently. BRIEF DESCRIPTION OF DRAWINGS

[0030] Figure 1 It is a system diagram of a pulse ablation system in embodiment 1 of the application;

[0031] Figure 2 It is a combined ablation schematic diagram of an endocardial catheter and an epicardial catheter in embodiment 1 of the application;

[0032] Figure 3 It is a pulse emission mode schematic diagram in embodiment 1 of the application;

[0033] Figure 4 It is a catheter electrode corresponding schematic diagram under one-to-one emission mode in embodiment 1 of the application;

[0034] Figure 5 It is a catheter electrode corresponding schematic diagram under one-to-many emission mode in embodiment 1 of the application;

[0035] Figure 6 It is a catheter electrode corresponding schematic diagram under many-to-many emission mode in embodiment 1 of the application;

[0036] Figure 7 It is a control interface diagram of a pulse generator in embodiment 1 of the application;

[0037] Figure 8 It is an interface schematic diagram under one-to-many emission mode in embodiment 1 of the application;

[0038] Figure 9 It is an interface schematic diagram under many-to-many emission mode in embodiment 1 of the application;

[0039] Figure 10 It is a corresponding example diagram of the catheter electrode corresponding diagram and the interface display schematic diagram in embodiment 1 of the application.

[0040] Figure 11 Graph showing the relationship between cell perforation, field intensity, and pulse width in Example 1 of the present invention;

[0041] Figure 12A This is a schematic diagram of the interface of a one-to-many pulse delivery mode of two catheters in Example 2 of the present invention;

[0042] Figure 12B This is a schematic diagram of the interface of the multi-to-multi pulse emission mode of two catheters in Example 2 of the present invention. DETAILED DESCRIPTION

[0043] The present invention will be further described in detail below in conjunction with test examples and specific embodiments. However, this should not be understood as limiting the scope of the present invention to the following embodiments, and all technologies implemented based on the present invention fall within the scope of the present invention.

[0044] Example 1

[0045] 1. System and device description

[0046] like Figure 1 As shown, 100 is a diagram of the system device, 101 is a patient, 102 is a puncture site, 103 is a catheter placed in the heart, 104 is an epicardial catheter, 105 and 106 are catheter handles, 107 is a positioning box with a built-in pulse channel and a positioning channel, 108 is a magnetic field generator, 109 is a display screen, 110 is a catheter positioning device, 111 is a pulse generating device, 112 is a data acquisition device, 113 is a data processor system, 114 is a myocardial area, 115 is the epicardial surface, 116 is the endocardial surface, 117 is the intracardiac catheter positioning imaging, and 118 is the epicardial catheter positioning imaging.

[0047] The intracardiac catheter 103 and epicardial catheter 104 are positionable and mapable catheters with pulse energy delivery. The position can be determined by collecting electrode impedance information and / or catheter built-in magnetic sensor position by data acquisition device 112. The mapping can be obtained by collecting voltage signals between electrodes or between an electrode and a neutral electrode. The positioning box 107 is a multifunctional integration, which includes a magnetic positioning module and various electrode channel wiring. Through the switching function in the positioning box, the electrodes can collect electrophysiological data, collect electric field positioning data, and deliver pulses. In particular, the positioning box 107 includes a pulse channel and a positioning channel. The pulse channel includes energy delivery channels established by one-to-one, one-to-many, or many-to-many electrodes between electrodes. 110 is a catheter positioning device, which controls the magnetic field generator 108 to generate a magnetic field and processes the magnetic sensor data on the data acquisition device 112. 113 is a data processing system, which mainly includes endocardial and epicardial modeling functions, relative electrode position monitoring functions, pulse delivery mode control, and pulse delivery parameter optimization design functions. 111 is a pulse generation device, which has the function of generating high-voltage pulses and controls the pulse waveform according to pulse voltage, pulse width, pulse spacing, pulse group number, pulse group spacing, and pulse waveform. In addition, the pulse generation device provides multiple commonly used pulse ablation delivery parameter preset schemes, which can be used for ablation of multiple typical parts of the heart (different myocardial thicknesses).

[0048] 2. Pulse delivery mode

[0049] Figure 2 A schematic diagram of intracardiac and epicardial ablation with a linear catheter and a ring-shaped catheter is given. 200 is an ablation schematic diagram of myocardial tissue. In actual application, one pulse ablation catheter can be selected for independent ablation on the endocardium or epicardium, or multiple catheters can be used for ablation. Figure 2 The description is for the ablation mode of multiple catheters. 201 is the upper cavity tissue, 202 is the lower cavity tissue, 203 is the myocardial tissue, 204 is the epicardium, 205 is the endocardium, 206 is the catheter placed in the epicardium, and 207 is the catheter placed in the endocardium.

[0050] As shown in Figure 3 300 is a pulse delivery mode schematic diagram, and 301 and 302 are electrodes. The composition mode of the pulse application electrode pair can be one-to-one, one-to-many, many-to-one, and many-to-many between electrodes on the same catheter; or one-to-one, one-to-many, many-to-one, and many-to-many between electrodes on two catheters.

[0051] Each delivery mode described here can be used as an implementation example. Taking two catheter combined pulse ablation as an example, three pulse delivery modes are described as follows:

[0052] Pulse delivery implementation example 1: one-to-one, as shown inFigure 4 Move the catheter to the area to be ablated so that the ablation target area is located at the set A i Electrode and B j Between electrodes, the operator can use system tools to measure the distance between the two electrodes, or set it to automatically monitor the distance between the two electrodes. The system solves the optimal preset scheme for pulse ablation based on the current electrode spacing and known electrode properties (mainly electrode width and electrode ring radius), and adjusts the preset value range of relevant parameters in the 111 pulse generator (pulse waveform, pulse voltage, pulse width, pulse spacing, number of pulse groups, and pulse group spacing). Application scenario: When the depth of single-sided pulse ablation of the endocardium or epicardium is difficult to reach the target lesion area, this delivery method can be selected.

[0053] Pulse emission implementation example 2: one-to-many, such as Figure 5 Move the catheter to the area to be ablated so that the ablation target area is located at the set A i Electrode and B i 、B j 、B k Between electrodes, the operator can use the system tool to measure the distance between the two electrodes, or set it to automatically monitor the distance between the two electrodes. The system solves the optimal preset scheme for pulse ablation based on the current electrode spacing and known electrode properties (mainly electrode width and electrode ring radius), and adjusts the preset value range of relevant parameters in the 111 pulse generator (pulse waveform, pulse voltage, pulse width, pulse spacing, number of pulse groups, pulse group spacing). Application scenario: When the depth of single-sided pulse ablation of the endocardium or epicardium is difficult to reach the target lesion area, and the ablation target is close to the endocardial side or epicardial side, this delivery method can be selected.

[0054] Pulse emission implementation example 3: many to many, such as Figure 6 Move the catheter to the area to be ablated so that the ablation target area is located at the set A i 、A j Electrode and B i 、B j 、B k Between electrodes, the operator can use the system tool to measure the distance between the two electrodes, or set it to automatically monitor the distance between the two electrodes. The system solves the optimal preset scheme for pulse ablation based on the current electrode spacing and known electrode properties (mainly electrode width, electrode ring radius), and adjusts the preset value range of relevant parameters in the 111 pulse generator (pulse waveform, pulse voltage, pulse width, pulse spacing, number of pulse groups, pulse group spacing). Application scenario: When the depth of single-sided pulse ablation of the endocardium or epicardium is difficult to reach the target lesion area, and the ablation target area is relatively large, this delivery method can be selected. Compared with the one-to-one delivery method, the many-to-many efficiency is higher.

[0055] 3. Pulse ablation method

[0056] Endocardial ablation: The catheter 207 placed in the endocardium can independently pulse ablation, the specific process is that the pulse organization applies pulse energy on the selected electrode according to the doctor's settings. The electrode discharge can select one electrode to another electrode discharge, one electrode to multiple electrode discharge, and multiple electrode to multiple electrode discharge. Figure 7 As shown in the control interface diagram of the pulse generator, the interface shows the model and electrodes of the catheter, and the doctor can select the on and off of the catheter electrodes on the pulse system control interface, and the positive and negative settings of the electrodes, as shown in the left figure. The user can switch the electrode state by touching the screen and clicking the electrode. Red is positive, blue is negative, and gray is unselected electrode. The first figure shows that the positive and negative electrodes of one electrode are alternately set, forming multiple one-to-one discharge modes (1-2, 2-3, 3-4, …). The second figure shows that the first electrode of the catheter head is red, indicating that the positive electrode is selected, and the second, third, and fourth electrodes are blue, indicating that the negative electrode is selected, forming a one-to-many ablation mode. The third figure shows a multiple-to-multiple discharge mode, in which electrodes 2 and 5 are positive, and electrodes 3 and 4 are negative, forming a multiple-to-multiple discharge mode.

[0057] Figure 8 The interface schematic diagram under the one-to-many discharge mode is given, 1 is red, indicating a positive electrode, 2, 3, and 4 are blue, indicating negative electrodes, and other gray electrodes are unselected electrodes. Through the selection of the scheme, the parameters of the pulse energy transmission between electrodes 1 and electrodes 2, 3, and 4 can be realized.

[0058] Figure 9 The interface schematic diagram under the multiple-to-multiple discharge mode is given, 5 and 2 are red, indicating positive electrodes, 3 and 4 are blue, indicating negative electrodes, and other gray electrodes are unselected electrodes. Through the selection of the scheme, the parameters of the pulse energy transmission between electrodes 5 and 2 and electrodes 3 and 4 can be realized.

[0059] Epicardial ablation: The catheter 207 placed in the epicardium can independently pulse ablation, the specific process is that the pulse organization applies pulse energy on the selected electrode according to the doctor's settings. The electrode discharge can select one electrode to another electrode discharge, one electrode to multiple electrode discharge, and multiple electrode to multiple electrode discharge.

[0060] Collaborative endocardial and epicardial ablation: The catheter placed in the endocardium and the catheter placed in the epicardium cooperate to ablate. For thicker myocardial tissue, separate endocardial ablation and epicardial ablation cannot achieve the ideal lesion depth, and collaborative discharge can be selected. When collaborative discharge is selected, the epicardial catheter electrode A i and the endocardial catheter electrode B jThe distance between the two catheters, and the pulse ablation parameters are set more effectively to achieve the optimal ablation effect.

[0061] Through a large number of experiments, the influence of different pulse parameters on the ablation depth and width is measured by the single variable method, and the relationship between the pulse parameters and the ablation depth and width is established. When the distance is known, the distance is equivalent to the depth, so it can be inferred what parameters to use. The system will recommend one of the preset schemes in the pulse system according to the distance, while limiting the setting range of the pulse parameters. The physician can directly use the recommended preset scheme (such as Figure 10 the second scheme in the middle is activated), or set the parameters within the recommended pulse parameter range.

[0062] Figure 10 In the middle, 109 illustrates the catheter in the heart chamber and outside the heart chamber, respectively establishing the endocardial model and epicardial model, and the system software displays the three-dimensional spatial position of the catheter in real time. The physician can obtain the relative position relationship of the catheter in real time on the display screen, and select which electrodes of the two catheters to perform collaborative ablation. The system automatically calculates the electrode distance according to the selection of the physician, and adapts the optimal pulse parameter preset scheme (here, the second preset scheme is illustrated).

[0063] 4. Ablation parameter description

[0064] The pulse parameters include pulse voltage, pulse waveform, pulse width, pulse number, pulse group number, pulse group interval, and electrode configuration. Among them, through research, the range of pulse voltage is 300V-5KV, the pulse width is 100ns-100us, the pulse number is 1-1000, the pulse group number is 1-90, the pulse group interval is 10ms-2000ms, and the pulse waveform can be unidirectional pulse or bidirectional pulse. The pulse parameters determine the properties of the pulse electric field, and the pulse electric field causes the cell membrane to form microholes. The microholes randomly generated on the cell membrane surface are formed by the joint action of electric field energy and thermal motion energy, among which the electric field energy can be controlled and determined by the pulse parameters, and is directly related to the transmembrane potential of the cell membrane, and plays a decisive role in the formation of microholes on the cell membrane surface.

[0065] The electric field strength generated according to the pulse parameters is the determining parameter for inducing the permeability change of the cell membrane, and controls the degree of cell surface material exchange. Increasing the number of pulses will further expand the permeability ratio. Increasing the pulse width time will increase the opportunity for macromolecules to exosmosis from the cell membrane into the cell. The shorter the pulse interval, the greater the cell membrane damage. Increasing the number of pulses improves the cell perforation efficiency.

[0066] For example, Figure 11As shown, 400 is a graph of the relationship between cell membrane perforation and field strength and pulse width. Region 1 is an electrically impermeable region, region 2 is a reversible electrically permeable region, and region 3 is an irreversible electrically permeable region. The field strength is critical, and only when a certain field strength is reached will the cell membrane be electrically perforated. Different field strengths have different pulse parameter configurations. In actual application, the operator can set the parameters in region 2 to attempt ablation on possible lesion areas, and after determining the lesion point, set the parameters in region 3 for final ablation; for a clear lesion point, the parameters can be directly set in region 3 for direct ablation.

[0067] In the system, each time the pulse parameters are set, there is actually a corresponding position point P(W, E) in Figure 11 , where W is the set pulse and E is the set field strength, which is determined by the voltage amplitude, the width and spacing of the electrodes connected to the system catheter. For a single catheter ablation, after the operator selects the pulse delivery mode each time, for example, selects multiple groups of one-to-one delivery (i.e., 1-2, 2-3, 3-4, …), the operator selects the corresponding preset scheme according to the lesion tissue depth at the current ablation position, or sets the parameters by himself / herself. When setting the parameters by himself / herself, the system displays which region and which position in the region the current set parameters fall into, which serves as real-time feedback for the operator to set the parameters. In fact, the multiple preset schemes provided by the system all correspond to a certain position in the irreversible perforation region in Figure 11 . Table 1 also provides the irreversible perforation minimum pressure threshold of different cell types. Figure 11

[0068] Table 1 Irreversible perforation minimum pressure threshold of different cell types

[0069]

[0070] As can be seen from Table 1, the irreversible perforation minimum pressure threshold of cardiomyocytes is 400 V / cm.

[0071] Example 2

[0072] Example 2 provides a specific application process of the pulse ablation system of the present application

[0073] (1) Endocardial ablation process:

[0074] High-voltage pulse preparation: The pulse generator capacitor device is charged according to the preset parameters.

[0075] Pulse ablation zone positioning: The catheter is placed in the heart, and the position of the region to be ablated is determined by mapping means or imaging means. The catheter is placed at the site to be ablated in the heart, and the impedance information between the electrode pairs to which high-voltage energy is to be applied is checked to ensure that the discharge channel is safe and effective. Under the action of the control circuit, high-voltage pulses are applied to the tissue to achieve the purpose of irreversible electrically perforating the lesion area cells.​

[0076] (2) Epicardial ablation procedure:

[0077] High-voltage pulse preparation: The pulse generator capacitor device is charged according to preset parameters (the preset parameters include pulse waveform, pulse voltage, pulse width, pulse interval, pulse group number, pulse group interval, etc.), which are set on the pulse generator touch interface or remotely set in the system software.

[0078] Pulse ablation zone positioning: The catheter is placed in the heart or / and epicardium, and the position of the lesion area to be ablated is determined by mapping or imaging means. The catheter is placed at the site to be ablated, and the impedance information between the electrode pairs to be applied with high-voltage energy is checked to ensure the safety and effectiveness of the discharge channel. The specific method includes: applying a high-frequency signal such as a 50 kHz current signal on the selected pulse discharge channel, measuring the voltage between the electrodes, and obtaining the impedance by dividing the voltage by the current. If the impedance is very large, it indicates an open circuit, and if it is too small, it indicates a short circuit. The safety and effectiveness of the discharge channel are determined by the impedance. Under the action of the control circuit, high-voltage pulses are applied to the tissue to achieve the purpose of irreversible electroporation of the lesion area cells.

[0079] (3) Intracardiac and epicardial collaborative ablation procedure:

[0080] Endocardial and epicardial surface model: The catheter is placed in the heart or / and epicardium to establish an endocardial or / and epicardial surface model.

[0081] Pulse ablation zone positioning: The catheter is placed in the heart or / and epicardium, and the position of the lesion area to be ablated is determined by mapping or imaging means.

[0082] Ablation target positioning: According to the positioning function provided by the system, the display screen presents the positions of the intracardiac and epicardial catheters and the electrodes of each catheter in real time. The commonly used target point selection method is the peripheral line of the lesion area. The intracardiac catheter is placed on the endocardial side of the lesion myocardium where the ablation target point is needed, and the epicardial catheter is placed on the epicardial side of the lesion myocardium where the ablation target point is needed. For small area lesion area, one catheter can be placed at the center of the lesion area, and the other catheter can be placed at the periphery of the lesion area.

[0083] Ablation scheme determination: According to the positioning function provided by the system, the display screen presents the positions of the intracardiac and epicardial catheters and the electrodes of each catheter in real time, and calculates the distance between the electrodes of the intracardiac catheter and the electrodes of the epicardial catheter. The operator evaluates the thickness of the lesion point tissue according to the distance, selects the intracardiac electrodes and epicardial electrodes that need to be discharged to form a high-voltage discharge electrode pair, and selects the pulse ablation parameters. As shown in FIG. 8, the composition of the pulse application electrode pair can be one-to-one, one-to-many, many-to-one, and many-to-many. Figure 3

[0084] ​High-voltage pulse preparation: according to the preset parameters, the pulse generator capacitor device is charged.

[0085] Pre-pulse check: check the impedance information between the electrode pairs that need to be applied with high-voltage energy, and ensure the safety and effectiveness of the discharge channel.

[0086] Pulse emission process: under the action of the control circuit, high-voltage pulses are applied to the tissue to achieve the purpose of irreversible electroporation of the lesion area cells.

[0087] As shown in FIG. 12, the system interface displays the selection state of the two catheter electrodes in real time. Figure 12A The schematic diagram shows a one-to-many pulse emission mode of two catheters, Figure 12B The schematic diagram shows a many-to-many pulse emission mode of two catheters.

[0088] If the doctor sets a monitoring electrode pair through the system software or sets a monitoring electrode pair through the pulse generator touch control screen, the system software interface and the pulse generator touch control screen will also display the distance information between the electrode pairs in real time, and the corresponding electrodes on the electrode model will be highlighted. The distance reflects the myocardial tissue thickness information.

[0089] Figure 12A The schematic diagram shows that the doctor selects the 2, 3, and 4 electrodes of the B catheter and the 3 electrode of the A catheter to form a many-to-one pulse emission mode, and the doctor sets the monitoring electrode pairs A3B2, A3B3, and A3B4. The interface will display the distance information of the electrode pairs.

[0090] Figure 12B The schematic diagram shows that the doctor selects the 3, 4, and 5 electrodes of the B catheter and the 2 and 3 electrodes of the A catheter to form a many-to-many pulse emission mode, and the doctor sets the monitoring electrode pairs A2B3, A2B4, A2B5, A3B3, A3B4, and A3B5. The interface will display the distance information of the electrode pairs.

[0091] Compared with single intracardiac pulse ablation and single extracardiac pulse ablation, the intracardiac and extracardiac collaborative pulse ablation has the characteristics of accurate quantification of ablation parameters, application of greater energy to the tissue, and deeper tissue ablation depth.

[0092] The above shows and describes the basic principles and main features of the present application and the advantages of the present application. For those skilled in the art, it is obvious that the present application can be realized in other specific forms without departing from the spirit or basic characteristics of the present application. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting, and the scope of the present application is defined by the appended claims rather than the above description, and therefore all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present application. Any reference signs in the claims should not be regarded as limiting the claims involved.

[0093] Furthermore, it should be understood that, although the specification is described in terms of embodiments, the embodiments are merely a representative of a single independent technical solution, and the specification is described in this manner only for the sake of clarity, and those skilled in the art should consider the specification as a whole, and the technical solutions in the embodiments can also be appropriately combined to form other embodiments that those skilled in the art can understand.

Claims

1. A pulse ablation system, comprising a catheter positioning device and a pulse generating device, characterized in that: It also includes a data processing system, a data acquisition device, a positioning box and a catheter. The catheter is provided with electrodes having both high-voltage pulse output function and positioning function; The positioning box has a built-in pulse channel, through which the high-voltage pulse output by the pulse generating device is output to the electrode of the catheter; the positioning box also has a built-in positioning channel, through which the impedance information and / or magnetic signal used to calculate the electrode position is output to the data acquisition device; The data processing system obtains the distance between the electrodes to be used for delivering high-voltage pulses based on the impedance information and / or magnetic signals, and sets the delivery parameters of the pulse generating device. The data processing system also sets the pulse delivery mode based on the electrode properties. The high-voltage pulses are output to the electrodes of the catheter in the following ways: between a positive electrode and a negative electrode, between a positive electrode and multiple negative electrodes, between multiple positive electrodes and a negative electrode, and between multiple positive electrodes and multiple negative electrodes. The pulse emission mode includes emission between a positive electrode and a negative electrode on the same catheter, emission between a positive electrode and multiple negative electrodes, emission between multiple positive electrodes and a negative electrode, and emission between multiple positive electrodes and multiple negative electrodes. It also includes emission between a positive electrode and a negative electrode between two catheters, emission between a positive electrode and multiple negative electrodes, emission between multiple positive electrodes and a negative electrode, and emission between multiple positive electrodes and multiple negative electrodes.

2. A pulse ablation system according to claim 1, characterized in that: The catheter includes an annular catheter and a linear catheter.

3. The pulse ablation system according to claim 1, wherein: The emission parameters include pulse waveform, pulse voltage, pulse width, pulse spacing, number of pulse groups and pulse group spacing.

4. The pulse ablation system according to claim 3, wherein: The pulse width and the pulse voltage determine the state of myocardial cell membrane perforation, which includes irreversible perforation, reversible perforation, and non-electroporation.

5. The pulse ablation system according to claim 4, characterized in that: The critical value of irreversible and reversible perforation of myocardial cell membrane is 400V / cm.

6. The pulse ablation system according to claim 1, wherein: The electrode properties include electrode width and electrode ring radius.

7. A pulse ablation system according to any one of claims 1 to 6, characterized in that: The data processing system is further configured to establish a model of the endocardium and epicardium based on the impedance information and / or the magnetic signal, and directly measure the thickness between the endocardium and epicardium from the model of the endocardium and epicardium.

8. The pulse ablation system according to claim 7, characterized in that: The data processing system is further configured to calculate the thickness between the endocardium and the epicardium based on the position information of the electrode on the catheter located inside the endocardium and the position information of the electrode on the catheter located outside the epicardium.

9. A pulse ablation platform, characterized in that: The pulse ablation system according to any one of claims 1 to 8 further comprises a graphical user interface of the data processing system, wherein the graphical user interface comprises a control area, a catheter status display area, and a scheme selection area. The control area includes a pulse dispensing mode setting button diagram, a pulse dispensing start button diagram, and a pulse dispensing stop button diagram; The catheter status display area displays the status of the electrodes on the catheter through a color map, and the electrode status includes: positive electrode, negative electrode and unselected electrode; The scheme selection area is provided with a plurality of buttons, and the buttons correspond to preset high-voltage pulse delivery parameters.

10. The pulse ablation platform according to claim 9, characterized in that: The graphical user interface further includes an area for displaying the distance between electrodes, and the distance between the electrodes is displayed in numbers.

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