Pulse ablation device and control module and control method thereof

Abstract

The invention discloses a pulse ablation device and a control module and a control method thereof, and relates to the technical field of medical equipment. The pulse ablation device includes: an expandable component including a plurality of first electrodes; a plurality of second electrodes are arranged on the flexible pipe, and the second electrodes and the first electrodes are axially arranged in a spaced mode; the control device comprises a high-voltage pulse transmitter and a low-voltage stimulator; the high-voltage pulse transmitter is communicated with the at least two first electrodes so as to form a pulse electric field between the first electrodes; when the high-voltage pulse transmitter is disconnected from the first electrode, the low-voltage stimulator is communicated with the second electrode to transmit a stimulation signal, and the first electrode is at least used for receiving an evoked signal caused by the stimulation signal. The device has the functions of ablation operation and effect verification, the steps of placing or adjusting the device on the human body can be reduced, the multiple first electrodes can be used for fixed-point judgment of the isolation effect, and therefore the efficiency, pertinence and safety of the ablation operation can be improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a pulse ablation device, a control module and a control method thereof. Background Art

[0002] Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, significantly impacting patients' quality of life, morbidity, and mortality. One existing treatment option is AF ablation.

[0003] Among patients who undergo pulmonary vein ablation procedures (e.g., radiofrequency ablation, cryoablation, and pulsed ablation), the rate of recurrent atrial fibrillation remains high. Incomplete pulmonary vein isolation and incomplete blockage of abnormal electrical signal pathways are considered the primary factors for the failure or recurrence of atrial fibrillation surgery. Therefore, after the planned ablation procedure is completed, assessing the completeness of pulmonary vein isolation, identifying areas of inadequate ablation, and performing supplemental ablations on unisolated points are crucial for improving the success rate of ablation procedures.

[0004] Current post-ablation examinations mainly rely on a mapping catheter inserted into the pulmonary vein to send a stimulation signal, while another mapping catheter is received in the coronary sinus. The completeness of the isolation is determined based on the ECG excitation signal (distinguished from the general ECG signal by its frequency) triggered by the stimulation signal.

[0005] However, when isolation is incomplete, this method cannot accurately determine the exact points where electrical conduction is not interrupted, resulting in the need for supplementary ablation of all points in the entire circle of the pulmonary veins when performing supplementary ablation. This results in problems such as long time consumption, large discharge volume, prolonged patient discomfort, and increased risk of hemolysis.

[0006] Furthermore, current ablation devices and ablation effect verification are usually implemented by two completely independent sets of devices, and the devices are not related to each other. It is difficult to directly obtain the location that requires additional ablation or convey the corresponding position information to the ablation device during ablation effect verification.

[0007] Therefore, how to improve the efficiency, targeting and safety of ablation surgery is a technical problem that those skilled in the art currently need to solve. Summary of the Invention

[0008] In view of this, an object of the present invention is to provide a pulse ablation device, a control module and a control method thereof, which can improve the efficiency, specificity and safety of ablation surgery.

[0009] To achieve the above object, the present invention provides the following technical solutions:

[0010] A pulse ablation device comprises: an expandable component, including a conducting cavity, a deformable main body and a plurality of first electrodes distributed circumferentially on the surface of the main body; a flexible tube, the distal end of the flexible tube extending from the distal end of the conducting cavity, a plurality of second electrodes being provided on the flexible tube, the second electrodes being axially separated from the first electrodes; a control device, the control device comprising a high-voltage pulse transmitter and a low-voltage stimulator; the high-voltage pulse transmitter is connected to at least two of the first electrodes to form a pulsed electric field between the first electrodes; when the high-voltage pulse transmitter is disconnected from the first electrode, the low-voltage stimulator is connected to the second electrode to transmit a stimulation signal, and the first electrode is at least used to receive an induced signal caused by the stimulation signal.

[0011] In some embodiments, the main body component is a balloon or basket with a changeable configuration; when the first electrode is switched from being connected to the high-voltage pulse transmitter to being used to detect the induced signal, the main body component maintains a static configuration.

[0012] In some embodiments, the high-voltage pulse transmitter is connected to all of the first electrodes to form a closed annular electric field around the main body component, and the high-voltage pulse transmitter is connected to some of the first electrodes to form a non-closed arc electric field around the main body component; the first electrode detects a feedback signal when the high-voltage pulse transmitter is disconnected from the first electrode, and when the low-voltage stimulator is connected to the second electrode to transmit a stimulation signal, the control device identifies the inclusion relationship of the feedback signal to the induced signal, and when the low-voltage stimulator is disconnected from the second electrode, the control device identifies the electrophysiological signal contained in the feedback signal; the control device also includes a delay conversion component that suppresses the first electrode from instantaneously switching from being connected to the high-voltage pulse transmitter to detecting the feedback signal.

[0013] In some embodiments, the first electrode detects a feedback signal when the high-voltage pulse transmitter is disconnected from the first electrode; the control device includes a preset first threshold, and the control device identifies that the feedback signal greater than the first threshold contains the induced signal, or the control device identifies that the feedback signal whose first-order derivative is greater than the second threshold contains the induced signal.

[0014] In some embodiments, the first electrode that identifies the induced signal is used as the reference electrode, and some or all of the first electrodes are connected to form a pulsed electric field at the location of the reference electrode, including: the reference electrode and the first electrode adjacent to the reference electrode are excited by the high-voltage pulse transmitter to form a pulsed electric field, or the first electrodes on both sides of the reference electrode are excited by the high-voltage pulse transmitter to form a pulsed electric field.

[0015] In some embodiments, a plurality of the second electrodes are distributed at the distal end of the flexible tube; and / or the distal end of the flexible tube is bent; and / or the distal end of the flexible tube is movable and / or rotatable relative to the main body component.

[0016] In some embodiments, the first electrode has a gradient shape, an equator is formed at the maximum radial dimension of the main body, and the first electrode is partially or completely arranged on the outer surface between the distal end of the main body and the equator.

[0017] In some embodiments, it also includes a display device and a signal amplification circuit connected to the control device; when the first electrode is used to detect the induced signal, the signal amplification circuit is connected to the first electrode; the signal amplification circuit is built into a multi-channel physiological recorder or a three-dimensional electrophysiological mapping system.

[0018] On the other hand, the present application also provides a control method for a pulse ablation device, comprising: expanding the main body component so that multiple first electrodes are circumferentially distributed on the surface of the main body component, setting the second electrode at the distal end of the main body component, and axially separating the second electrode from the first electrode; the working mode of the pulse ablation device includes a first mode and a second mode; in the first mode, at least two of the first electrodes are excited by a high-voltage pulse transmitter, and the two adjacent first electrodes excited have opposite polarities, and a pulse ablation electric field is formed between the excited first electrodes; in the second mode, the second electrode is excited by a low-voltage stimulator to send a stimulation signal for causing an induced signal, and multiple first electrodes collect feedback signals, and the control device identifies that the feedback signal that meets the first set condition contains the induced signal, and the control device identifies the number of the first electrode that received the induced signal.

[0019] In some embodiments, the following steps are performed in order:

[0020] S110: The pulse ablation device stimulates all the first electrodes to form a closed circular electric field around the main body in the first mode; S120: The pulse ablation device stimulates the second electrodes to send multiple stimulation signals in multiple directions in the second mode, and each first electrode collects a feedback signal. The control device identifies that the feedback signal that meets the first set condition contains the induced signal, and the control device identifies the number of the first electrode that receives the induced signal; S130: The first electrode with the number is used as the reference electrode, and in the first mode, the reference electrode and its adjacent first electrodes are stimulated or only the first electrodes on both sides of the adjacent reference electrode are stimulated.

[0021] In some embodiments, the following steps are performed in sequence: S101: the pulse ablation device stimulates the second electrode to send multiple stimulation signals in multiple directions in the second mode, each of the first electrodes collects a feedback signal, and the control device identifies the feedback signal that meets the second set condition; S102: the posture of the main body component is adjusted, wherein the main body component is deformable; S103: S101 and S102 are repeated until the feedback signals collected by each of the first electrodes meet the second set condition; S110: the pulse ablation device stimulates all of the first electrodes in the first mode to form a closed annular electric field around the main body component.

[0022] In a third aspect of the present application, a control module of a pulse ablation device is further provided, comprising:

[0023] A control device, comprising a high-voltage pulse transmitter and a low-voltage stimulator, for controlling the operation of the aforementioned pulse ablation device, wherein the operation mode of the pulse ablation device comprises a first mode and a second mode; in the first mode, the high-voltage pulse transmitter is controlled to excite at least two of the first electrodes, wherein the two adjacent first electrodes being excited have opposite polarities, and a pulse ablation electric field is formed between the excited first electrodes; in the second mode, the low-voltage stimulator is controlled to excite and send a stimulation signal to the second electrode, feedback signals are collected through multiple first electrodes, feedback signals that meet the first set condition are identified as containing induced signals, and the numbers of the first electrodes containing induced signals are identified.

[0024] The above-mentioned pulse ablation device and its control module and control method, due to the application of pulse electric field technology for ablation, result in the first electrode contact area itself being a weak position forming the ablation area. The first electrode and the second electrode of the present invention are separated to ensure that the two cannot be arranged on the same side of the ablation area to facilitate verification of the ablation effect, and a high-voltage pulse transmitter is provided to cooperate with the first electrode that can transmit signals to perform ablation surgery. When verifying the ablation effect, a low-voltage stimulator cooperates with the second electrode to provide a stimulation signal. The first electrode can be switched to a receiving end for receiving an induced signal caused by the stimulation signal at the weak position. If the induced signal can be received, it indicates that the weak position constitutes an insufficiently ablated area, so that the corresponding first electrode is independently stimulated again around the weak position, so as to conveniently achieve a continuously closed ablation area and more predictably complete the treatment purpose. The ablation device of the present invention has both ablation function and ablation effect verification function. It can directly identify the position where ablation is insufficient without changing the position of the device in the patient's body after ablation, and transmit it to the control device for targeted supplementary ablation. Overall ablation, effect verification, and supplementary ablation can be performed continuously, reducing the placement or adjustment steps of the device in the human body. It has a streamlined structure and is easy to operate, which improves the efficiency of the operation and can effectively avoid the risk of hemolysis caused by excessive ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0026] Figure 1 This is a schematic structural diagram of a pulse ablation device according to a specific embodiment of the present invention;

[0027] Figure 2 A partial structural diagram of the distal end of a pulse ablation device according to a specific embodiment of the present invention;

[0028] Figure 3 This is a schematic diagram of the application of the pulse ablation device according to a specific embodiment of the present invention;

[0029] Figure 4 This is a schematic diagram of the electrical control of a pulse ablation device according to a specific embodiment of the present invention;

[0030] Figure 5 A schematic diagram comparing stimulation signals and feedback signals of a pulse ablation device according to a specific embodiment of the present invention;

[0031] Figure 6 This is a flow chart of a control method for a pulse ablation device according to a specific embodiment of the present invention.

[0032] Reference numerals:

[0033] Balloon 1, first electrode 2, flexible tube 4, second electrode 41, catheter 3, conduction cavity 31, multi-channel physiological recorder 5, three-dimensional electrophysiological measurement system 6, display device 7, control host 8, high-voltage pulse transmitter 9, low-voltage stimulator 10. DETAILED DESCRIPTION

[0034] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0035] To help those skilled in the art better understand the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. Regarding the distal and proximal ends in the specific embodiments, the distal end refers to the portion of the corresponding component away from the operator, typically the end of the component that enters the patient's body or the surgical area, while the proximal end refers to the portion of the corresponding component that is closer to the operator, typically the end held or manipulated by the operator. For a single component, the end closer to the operator is the proximal end, and the end farther from the operator is the distal end. Furthermore, in the present invention, unless otherwise expressly specified or limited, the terms "installed," "connected," "connected," "fixed," and "connected" should be interpreted broadly. For example, they can mean fixed, detachable, or integral; mechanical or electrical; direct, indirect, through an intermediary, or internally connected between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0036] The core of the present invention is to provide a pulse ablation device and its control module and control method, which can improve the efficiency, pertinence and safety of ablation surgery.

[0037] In a first aspect, the present invention provides a pulse ablation device, please refer to Figures 1 to 4 , including expandable components, flexible pipe 4 and control device. Figure 2 and Figure 3 As shown, the expandable assembly includes a conducting cavity 31, a deformable main body 1, and a plurality of first electrodes 2 circumferentially distributed on the surface of the main body 1. The distal end of the flexible tube 4 extends from the distal end of the conducting cavity 31. The conducting cavity 31 is a cavity opened inside the catheter 3 for passing the flexible tube 4. The main body 1 is connected to the distal end of the catheter 3. A plurality of second electrodes 41 are provided on the flexible tube 4. The second electrodes 41 are axially separated from the first electrodes 2 so as to be affixed to different locations. A control device is provided, the control device including a high-voltage pulse transmitter 9 and a low-voltage stimulator 10; the high-voltage pulse transmitter 9 is connected to at least two of the first electrodes 2 to form a pulsed electric field between the first electrodes 2; when the high-voltage pulse transmitter 9 is disconnected from the first electrodes 2, the low-voltage stimulator 10 is connected to the second electrodes 41 to transmit stimulation signals, and the first electrodes 2 are at least used to receive induced signals caused by the stimulation signals.

[0038] The pulse ablation device in this embodiment, because it uses pulsed electric field technology for ablation, can form an ablation area without relying on the contact between the first electrode 2 and the area to be ablated. Moreover, because the pulsed electric field technology has the characteristic of having a greater electric field strength in the area between the first electrodes 2 than in the area where the first electrode 2 itself is in contact, the insufficiently ablated area is more likely to form in the area where the first electrode 2 itself is in contact. In addition, since there are multiple first electrodes 2, feedback signals can be obtained from different points for point-by-point judgment of the isolation effect. By directly analyzing the feedback signals received by each first electrode 2 for the presence of induced signals, the location of the insufficiently ablated area can be achieved. There is no need for the doctor to manually locate each point frequently and transmit stimulation signals and receive induced signals to check whether the ablation area is closed. Instead, if the ablation area is not continuously closed, further direct feedback is provided on the insufficiently ablated area.

[0039] At the same time, the second electrode 41 and the first electrode 2 are arranged separately to ensure that the two are not arranged on the same side of the ablation area, so that the transmission path from the second electrode 41 to the first electrode 2 needs to cross the ablation boundary. For example, the first electrode 2 is close to the pulmonary vein orifice or vestibule (on one side of the ablation area), and the second electrode 41 is close to the pulmonary vein (directly on the ablation area or on the other side of the ablation area). If the signal transmitted from the second electrode 41 to the first electrode 2 can be successfully received, it indicates that there is a conduction path through the pulmonary vein myocardial cells, verifying that there is an uninterrupted point at the first electrode 2.

[0040] In general, the high-voltage pulse transmitter 9 cooperates with the first electrode 2 that can transmit signals to perform ablation surgery, and when verifying the ablation effect, the low-voltage stimulator 10 cooperates with the second electrode 41 to provide a stimulation signal, and the first electrode 2 can be switched to a receiving end. The ablation effect can be verified with the help of the information carried by the feedback signal, so that the device has the functions of both ablation surgery and effect verification, and the overall ablation, effect verification, and supplementary ablation can be performed continuously, reducing the placement or adjustment steps of the device in the human body. Moreover, since there are multiple first electrodes 2, feedback signals can be obtained from different points for fixed-point judgment of the isolation effect, thereby improving the efficiency, pertinence and safety of the ablation surgery.

[0041] In some embodiments, the first electrode 2 and the second electrode 41 can be metal electrodes.

[0042] In some embodiments, the distal end of the catheter 3 is connected to a main body component. In its initial state, the main body component may extend in an axial direction. The distal end of the catheter 3 can be extended and retracted to adjust the outer diameter of the main body component, expanding it to form a spherical outer profile. The cable connected to the first electrode 2 is bundled within the catheter. The catheter 3 is hollow to form a conducting cavity 31 for receiving the flexible tube 4.

[0043] In some embodiments, as Figure 2As shown, the main body 1 is a balloon with a variable configuration. Specifically, the balloon 1 can be made of biocompatible materials such as TPU and PEBAX. The catheter 3 is further provided with a perfusion lumen connected to the balloon 1. In other embodiments, the main body 1 can also be a basket with a variable configuration, specifically achieving deformation through self-expansion, or can be replaced with an expandable cage-like stent or other structure.

[0044] Specifically, during an ablation procedure (whole ablation or supplementary ablation), the balloon 1 contracts in the sheath when it is delivered into the blood vessel. After reaching the target position, the balloon 1 extends from the sheath and is filled with gas / liquid through a tube, causing the balloon 1 to expand from a contracted state into a full sphere. In the filled state, the balloon 1 can be stuck at the pulmonary vein orifice, achieving a good positioning effect.

[0045] In some embodiments, because the electric field intensity of the PFA (Pulsed Field Ablation) electric field pair is lower at the electrode site, it is more likely to be an inadequately ablated area. In some embodiments, during the process of switching the first electrode 2 from being connected to the high-voltage pulse transmitter 9 to being used for detecting feedback signals, the balloon 1 maintains a static configuration. This ensures that the balloon 1 and the first electrode 2 remain stable in place during the transition from overall ablation to ablation effect verification. If an inadequately ablated area is identified, the ablation intensity at the inadequately ablated area can be directly enhanced by selectively stimulating a portion of the first electrode 2, that is, supplementary ablation is performed in the corresponding first electrode area, rather than blindly stimulating all first electrodes 2 multiple times to form an over-ablated ablation zone. Of course, in other embodiments, the balloon 1 can also be rotated after identifying the inadequate area and then selectively supplementary ablation is performed.

[0046] In some embodiments, the first electrode 2 is a flexible electrode positioned and attached to the outer surface of the balloon 1 to adapt to the deformable main body 1. For example, the first electrode 2 is based on a base material such as polyimide or polyester. An adhesive is used to connect a conductive copper foil to the base material. The surface of the conductive copper foil is treated with gold immersion or gold plating. Polyimide, polyester, and conductive copper foil all have good flexibility, which can ensure the flexibility of the first electrode 2.

[0047] In addition, a plurality of first electrodes 2 are sequentially arranged on the outside of the balloon 1 along the circumferential direction, and specifically can be evenly arranged circumferentially.

[0048] In some embodiments, as Figure 2 and Figure 3 As shown, the first electrode 2 has a gradient shape, such as a cone or teardrop. Compared to a uniformly wide electrode structure, this first electrode 2 can increase the overall flexibility of the electrode when retracted into the sheath, avoiding problems such as loose adhesion and warping caused by different material hardness and overly large electrodes.

[0049] In addition, based on biological anatomy, the sizes of pulmonary vein orifices vary greatly among different populations. For example, Figure 2 and Figure 3 As shown, an equator is formed at the maximum radial dimension of the balloon 1, and the first electrode 2 is partially or completely arranged on the outer surface between the distal end of the main body 1 and the equator. At this time, the part of the first electrode 2 in contact with the tissue generally covers the front hemisphere of the balloon 1, that is, the side close to the distal end, which can adapt to pulmonary vein openings of different sizes, ensuring that the first electrode 2 has a certain radial contact area with the tissue. The corresponding setting is a gradient shape, wide at the proximal end and narrow at the distal end, so as to ensure the spacing between the two first electrodes and improve the uniformity of the pulsed electric field distribution on the periphery of the main body.

[0050] In some embodiments, the distal end of the flexible tube 4 extends from the distal end of the conducting cavity 31 of the expandable component, and the flexible tube 4 is provided with a plurality of second electrodes 41 , specifically one or more.

[0051] In some embodiments, as Figure 3 As shown, a plurality of second electrodes 41 are distributed at the distal end of the flexible tube 4 to provide stimulation at multiple points and ensure comprehensive stimulation.

[0052] In some embodiments, the distal end of the flexible tube 4 is bent to adapt to the shape of the location to be fitted. Figure 3 The distal end of the flexible tube 4 can be bent into a circular ring shape. Within this tube segment, along its extension direction, the second electrodes 41 are sequentially arranged circumferentially. Specifically, they can be spaced and evenly arranged, so that each second electrode 41 forms a ring shape and closely adheres to the pulmonary vein cavity, providing a generally circumferentially distributed stimulation signal. Alternatively, the distal end of the flexible tube 4 can be bent into a tube segment, such as a circular arc or spiral. Furthermore, the second electrode 41 is an electrode ring that is sleeved and fixed to the outer surface of the distal end of the flexible tube 4. The circumferential distribution of multiple second electrodes 41 helps ensure that each second electrode 41 is positioned differently within the pulmonary vein cavity, thereby ensuring that the emitted stimulation signals are multi-directional, reducing the number of adjustments required to adjust the contact position of the second electrodes 41 with the pulmonary vein cavity. In conjunction with the rotation of the flexible tube 4, sufficient stimulation signals in various directions are transmitted toward the ablation site, improving the adequacy and accuracy of the feedback signals received by each first electrode 2 and avoiding the misidentification of insufficiently ablated sites as fully ablated sites.

[0053] In some embodiments, as Figure 3As shown, the distal end of the flexible tube 4 is fixed relative to the main body 1, ensuring that the flexible tube 4 can remain stably in the pulmonary vein during the ablation procedure. Of course, in other embodiments, the distal end of the flexible tube 4 can move and / or rotate relative to the main body 1 to further expand the points that can be contacted by the second electrode 41, thereby expanding the range of stimulation signals that can be provided. In this case, the movement of the distal end of the flexible tube 4 relative to the main body 1 can specifically be that the flexible tube 4 can move as a whole within the conduction cavity 31, or only the distal end region of the flexible tube 4 can move accordingly under the control of an electronic control component outside the human body.

[0054] In the control device, such as Figure 4 As shown, it includes a control host 8, a high-voltage pulse transmitter 9, and a low-voltage stimulator 10. The high-voltage pulse transmitter 9 and the low-voltage stimulator 10 can be electrically connected or communicatively connected to the control host 8 and are uniformly controlled by the control host 8, such as controlling the on / off status. Among them, the high-voltage pulse transmitter 9 is connected to the first electrode 2, specifically by a wire or other electrical connector, and the low-voltage stimulator 10 is connected to the second electrode 41, specifically by a wire or other electrical connector.

[0055] During the ablation procedure (both overall and supplemental ablation), the high-voltage pulse transmitter 9 is connected to the first electrodes 2, with each first electrode 2 acting as a transmitter. When connected, the high-voltage pulse transmitter 9 can individually and independently provide several watts of energy to each first electrode 2. Adjacent first electrodes 2 can alternately discharge in the same or opposite directions (+-+- or ++--). Furthermore, the high-voltage pulse transmitter 9 can control the discharge of any one or more pairs of electrodes, with the two first electrodes 2 in each pair having opposite polarities. During ablation, any adjacent first electrodes 2 can function as an electrode pair during the discharge treatment process, and the control host 8 can flexibly control which pair or pairs of first electrodes 2 receive the discharge treatment as needed.

[0056] In some embodiments, the high-voltage pulse transmitter 9 is connected to all of the first electrodes 2 to form a closed annular electric field around the main body component, and the high-voltage pulse transmitter 9 is connected to some of the first electrodes 2 to form a non-closed arc electric field around the main body component. Specifically, during operation, the high-voltage pulse transmitter 9 is connected to all of the first electrodes 2 to form a closed annular electric field around the main body component, and overall ablation is performed before the ablation effect verification of the ablation surgery; after the ablation effect verification, the supplementary ablation includes: the high-voltage pulse transmitter 9 is connected to some of the first electrodes 2 to form a non-closed arc electric field around the main body component. The non-closed arc electric field is a targeted supplement to the ablation effect of the closed arc electric field. The targeted ablation effect of the non-closed arc electric field is accumulated with the closed annular electric field, which is conducive to forming a continuous closed ablation area with appropriate ablation depth on the periphery of the main body component.

[0057] In some embodiments, the first electrode 2 detects a feedback signal when the high-voltage pulse transmitter 9 is disconnected from the first electrode 2, and when the low-voltage stimulator 10 is connected to the second electrode 41 to transmit a stimulation signal, the control device identifies the inclusion relationship of the feedback signal to the induced signal, and the first electrode 2 can be used to detect the feedback signal to verify the attachment condition of the main body component 1 or to verify the ablation effect of the pulsed electric field.

[0058] Verification of the attachment of the main component 1 or the first electrode 2 is mainly performed before ablation surgery, mainly before overall ablation, and the first electrode 2 on it can enter the pulmonary vein cavity to map the current potential, ensuring that each first electrode 2 can have a certain area of ​​contact with the tissue.

[0059] Specifically, the balloon 1 is delivered into the pulmonary vein orifice, the first electrode 2 is attached to the set position of the tissue to be detected, and the first electrode 2 receives the myocardial signal as a feedback signal; if one (or more) of the first electrodes 2 does not receive the feedback signal or receives a set weak signal (after the stimulation signal is emitted, the amplitude of the received signal is significantly attenuated and the signal-to-noise ratio increases), such as the signal voltage amplitude of the myocardial cells received by the first electrode 2 is only 0-20% of the voltage amplitude of the stimulation signal itself, it may indicate that the first electrode 2 at this (or more) position is not completely attached or not attached in place. In some other embodiments, the attachment stability can also be identified by observing the impedance value and the change in contact force; the operator needs to adjust the position of the balloon 1. It is preferred to adjust until each first electrode 2 shows adhesion to the tissue before performing overall excitation of all first electrodes 2 to ensure that the overall ablation of the overall excitation has better adhesion and ablation effects, and reduce the number and complexity of subsequent supplementary ablations. Specifically, the second electrode 41 resends the stimulation signal, and repeats the above-mentioned steps of first electrode 2 detection and balloon 1 adjustment until all first electrodes 2 successfully receive the set correct feedback signal, thereby achieving the effect of each first electrode 2 being completely adhered to the pulmonary vein orifice (or vestibule).

[0060] Verification of the ablation efficacy of the pulsed electric field is primarily performed after overall ablation and supplemental ablation. Second electrode 41 transmits a stimulation signal through the surface of the pulmonary vein, and first electrode 2 receives the feedback signal. If each first electrode 2 receives no signal or a weak signal, the pulmonary vein is considered successfully isolated and the corresponding first electrode 2 has passed ablation.

[0061] In some embodiments, the first electrode 2 detects a feedback signal when the high-voltage pulse transmitter 9 is disconnected from the first electrode 2, and when the low-voltage stimulator 10 is disconnected from the second electrode 41, the control device identifies the electrophysiological signal contained in the feedback signal. The electrophysiological signal collected when the second electrode 41 is disconnected from the low-voltage stimulator 10 does not rely on the output of the stimulation signal, but directly collects the electrocardiographic signal information directly on the contact part (used to display the potential of the contact part or observe whether the first electrode 2 can be powered on and work normally).

[0062] In some embodiments, the control device further includes a delay conversion component for suppressing the instantaneous transition of the first electrode 2 from connection with the high-voltage pulse transmitter 9 to detecting the feedback signal, i.e., delaying the switching of the first electrode 2 from the transmission mode to the reception mode, thereby avoiding interference between the transmitted and received signals. Optionally, the delay conversion component may be an electronic circuit in the control host 8, such as a digital delay circuit.

[0063] In terms of ablation effect verification and detection, the first electrode 2 serves as a receiving end and is disconnected from the high-voltage pulse transmitter 9 .

[0064] Because in some balloons 1, non-ionized contrast agent is usually injected into the front section, or the balloon 1 blocks the blood vessel, causing blood to fill the distal end of the main body, resulting in the exposed part of the front section of the first electrode 2 of the balloon 1 being exposed to the pulmonary vein. The stimulation signal released by the second electrode 41 will be transmitted to the first electrode 2 through the mixed blood and contrast agent. In this case, the first electrode 2 may correspondingly collect a very weak stimulation signal conducted through the liquid. If the feedback signal only includes this signal, refer to Figure 5 Point ② in the figure cannot actually reflect the problem of insufficient isolation.

[0065] On this basis, in some embodiments, the control device includes a preset first threshold value, identifies and determines that the feedback signal greater than the first threshold value contains the induced signal, selects the first electrode 2 whose feedback signal is greater than the first threshold value as the reference electrode, and the location of the reference electrode is the insufficiently ablated area, which serves as the point for supplementary ablation surgery. The feedback signal is an electrical signal, and the first threshold value is a specific preset voltage value.

[0066] At this time, by defining the first threshold, the feedback signal including only the weak stimulation signal conducted by the liquid is excluded, that is, Figure 5 In case ②, the feedback signal collected by the first electrode 2 is lower than the first threshold value set by the control device, and it is considered that the isolation is sufficient; if the feedback signal collected by the first electrode 2 is higher than the first threshold value, it is determined that the certain range where the first electrode 2 that collected the feedback signal is located is not completely isolated, which can improve the accuracy of the judgment of the ablation effect.

[0067] In addition, since the feedback signal received by the first electrode 2 may include near-field signals generated by the excitation of myocardial cells and far-field signals caused by the original stimulation signal generated by long-distance induction, the key basis for determining whether the pulmonary vein isolation is successful is the strength of the near-field signal.

[0068] On this basis, to improve the accuracy of ablation effect judgment, based on the morphological characteristics of the relatively flat far-field signal and the relatively sharp near-field signal, the signal morphology can be distinguished to obtain information about the near-field signal. Specifically, in some other embodiments, the control device includes a preset second threshold value, identifies and determines that the feedback signal whose first-order derivative is greater than the second threshold value contains the induced signal, selects the first electrode 2 whose first-order derivative corresponding to the feedback signal is greater than the second threshold value as the reference electrode, and the location of the reference electrode is the insufficiently ablated area, thereby more accurately reflecting the ablation effect.

[0069] The aforementioned first threshold and second threshold can both be preset parameter values ​​or proportional values ​​relative to the stimulation signal parameters on the basis of their temporal connection. For example, if the amplitude or first-order derivative value of the collected feedback signal is set to be lower than 20% of the amplitude or first-order derivative value of the stimulation signal, it can be said that the part is a sufficiently ablated part, otherwise it means that the position where the signal is collected is an insufficiently ablated part.

[0070] During the supplementary ablation process, that is, when performing another ablation operation on the insufficiently ablated part after the ablation effect is verified, it can specifically include: using the first electrode 2 that identifies the induced signal as the reference electrode, and performing supplementary ablation on the position where the reference electrode is located. Specifically, the reference electrode and the first electrode 2 adjacent to the reference electrode are excited by the high-voltage pulse transmitter 9 to form a pulsed electric field, or the first electrodes 2 on both sides of the reference electrode (with opposite polarities, and the energy intensity can be increased accordingly due to the increase in the spacing) are excited by the high-voltage pulse transmitter 9 to form a pulsed electric field, thereby achieving precise re-ablation of the insufficiently ablated position or area.

[0071] Specifically, after the point where isolation is insufficient is determined based on the ablation effect verification, the control host 8 can automatically decide or recommend a supplementary ablation plan to the operator. For example, the first electrode 2 at the point and the most suitable adjacent first electrode 2 are used as discharge targets, and supplementary discharge ablation is automatically performed; or, supplementary ablation can also be that the control host 8 prompts or displays the ablation effect verification and prompts the operator to the position of the insufficiently isolated electrode, and the operator decides the supplementary ablation method and the first electrode 2 for re-emission based on experience.

[0072] To facilitate the determination of surgical progress, Figure 4As shown, the pulse ablation device also includes a display device 7 and a signal amplification circuit connected to the control device, specifically electrically connected to a control host 8. The display device 7 can be used to display the surgical progress, including the ablation procedure, ablation effect verification, and supplemental ablation. The signal amplification circuit can be used to amplify the feedback signal from the first electrode 2.

[0073] In some embodiments, the display device 7 and the signal amplification circuit are built into the multi-channel physiological recorder 5 or a three-dimensional electrophysiological mapping system, which may specifically be a three-dimensional cardiac electrophysiological mapping system. Alternatively, the signal amplification circuit is built into the multi-channel physiological recorder 5 or the three-dimensional electrophysiological mapping system. The display device 7 is a separate device electrically connected to the control device and is used to display information such as patient information, the current surgical stage, parameters related to ablation effects, and recommended surgical procedures.

[0074] In some embodiments, the signal amplification circuit is connected to the first electrode 2 in the second mode. In this case, after the second electrode 41 releases a stimulation signal to the surface tissue of the pulmonary vein cavity and the first electrode 2 receives a feedback signal, the signal amplification circuit can amplify the feedback signal received by the first electrode 2, and can record or display the electrophysiological signal with the help of the multi-channel physiological recorder 5 or the three-dimensional electrophysiological mapping system, thereby conveniently displaying or analyzing the ablation effect.

[0075] The pulse ablation device in the embodiment of the present application has the following working principles:

[0076] Whole-body ablation: the first electrode 2 is placed against the pulmonary vein orifice or vestibule, the second electrode 41 is placed against the pulmonary vein, and the high-voltage pulse transmitter 9 excites all first electrodes 2 to perform circumferential whole-body ablation.

[0077] Verification of ablation effect: After the overall ablation surgery, an isolation zone is formed at the pulmonary vein orifice. The second electrode 41 sends a stimulation signal, and the first electrode 2 is used to collect feedback signals. Based on the collected feedback signals, the points where isolation is incomplete are determined.

[0078] Supplementary ablation: When ablation verification indicates incomplete pulmonary vein isolation at one or more first electrodes, supplementary ablation is required, performing supplementary discharge electric field ablation on the electrode pairs at the corresponding locations. If only a single first electrode 2 receives a feedback signal indicating incomplete isolation, this single first electrode 2 is used as the reference electrode. Supplementary discharge therapy can then be performed with the reference electrode and any first electrode 2 on either side to form an electrode pair. This continues until the first electrode 2 in that area no longer receives the stimulation signal from the second electrode 41, achieving complete pulmonary vein isolation. It can be understood that, in addition to the above-mentioned identification of a single electrode indicating that the ablation at the contact position is insufficient, it can also be applied by analogy to the identification of two first electrodes 2 receiving feedback signals containing induced signals. In this case, the two first electrodes 2 can both be used as reference electrodes to form a supplementary ablation scheme. If multiple first electrodes 2 receive feedback signals containing induced signals, supplementary ablation can also be performed according to the above-mentioned scheme. In addition to supplementary ablation, the lack of overall ablation intensity can be compensated by adding the number of pulses, or the degree of contact and contact position can be readjusted to obtain better ablation effects and improve ablation efficiency.

[0079] In addition to the above-mentioned pulse ablation device, the present invention also provides a control method using the above-mentioned pulse ablation device, which includes the following steps:

[0080] The main body is expanded so that a plurality of first electrodes 2 are circumferentially distributed on the surface of the main body, and a second electrode 41 is disposed at the distal end of the main body, with the second electrode 41 axially separated from the first electrode 2;

[0081] The operating modes of the pulse ablation device include a first mode and a second mode;

[0082] In the first mode, at least two first electrodes 2 are excited by the high-voltage pulse transmitter 9. The two adjacent excited first electrodes 2 have opposite polarities. A pulsed ablation electric field is formed between the excited first electrodes 2, and an ablation area is generated by the ablation electric field.

[0083] In the second mode, the second electrode 41 is stimulated by the low-voltage stimulator 10 to send a stimulation signal for causing an induced signal, and multiple first electrodes 2 collect feedback signals. The control device identifies that the feedback signal that meets the first set condition contains the induced signal. The control device identifies the number of the first electrode 2 corresponding to the feedback signal that meets the first set condition, that is, the control device identifies the number of the first electrode 2 that receives the induced signal, and the position of the first electrode 2 with this number is the area where ablation is insufficient.

[0084] The first setting condition may be: the feedback signal is greater than a first threshold, and / or the first-order derivative corresponding to the feedback signal is greater than a second threshold.

[0085] Based on the above steps, by identifying the feedback signal that meets the first set condition, the position where isolation is incomplete and ablation is insufficient can be automatically identified, thereby improving the automation and efficiency of the ablation surgery.

[0086] like Figure 4 As shown, the control device includes a high-voltage pulse transmitter 9 and a low-voltage stimulator 10. The high-voltage pulse transmitter 9 is connected to the first electrode 2, and the low-voltage stimulator 10 is connected to the second electrode 41. The connected and disconnected states can be switched, corresponding to the two working modes of the pulse ablation device, including the first mode and the second mode. Figure 4 In the figure, a solid arrow may indicate a connected state, and a dotted arrow may indicate a disconnected state.

[0087] In the first mode, the high-voltage pulse transmitter 9 communicates with at least two first electrodes 2 to form a pulsed electric field between the first electrodes 2. This mode is used for performing ablation procedures, including both overall ablation and supplemental ablation. Specifically, the front end of the first electrode 2 is in close contact with the myocardial tissue at the pulmonary vein orifice. The high-voltage pulse output by the high-voltage pulse transmitter 9 is transmitted to the first electrodes 2 via a cable, forming a pulsed electric field between the first electrodes 2. The high-voltage pulse clamps the potential inside and outside the cell membrane, causing cell inactivation and apoptosis, thereby achieving ablation.

[0088] In the second mode, the high voltage pulse transmitter 9 is disconnected from the first electrode 2, and the low voltage stimulator 10 is connected to the second electrode 41 to transmit a stimulation signal, and the first electrode 2 is used to detect an induced signal caused by the stimulation signal.

[0089] It should be noted that when the first electrode 2 receives a feedback signal, it is possible that no signal is received, or only a weak stimulation signal transmitted to the first electrode 2 by the mixed blood flow and contrast agent in the blood vessels is received. These two situations can be considered to be completely isolated or complete; it is also possible that the received feedback signal includes the myocardial cells receiving the stimulation signal and being excited to generate electrical signals (i.e., induced signals). This situation is usually considered to be non-isolation or incomplete isolation.

[0090] Specific reference Figure 5In the three signal comparison diagrams, ①, ②, and ③ are all time on the horizontal axis and signal amplitude on the vertical axis. Second electrode 41 extends to the distal end of the pulmonary vein orifice (at a certain distance from the orifice), and first electrode 2 is positioned near the orifice. Second electrode 41 transmits a stimulation signal to the position where it is in contact. ① is the image of the stimulation signal. First electrode 2 is used to receive feedback signals. When the corresponding image is ②, it only includes a weak stimulation signal (signal amplitude is significantly reduced), which is considered sufficient isolation and does not require additional ablation at the corresponding point. When the corresponding image is ③, it includes both myocardial signals and weak stimulation signals. Further analysis is required to determine whether the first-order derivative of the myocardial signal meets the second threshold constraint. For example, if the myocardial signal in ③ is relatively rounded and has a significantly reduced amplitude, indicating a transmission relationship with the far-field ECG signal, it can be considered sufficient isolation and does not require additional ablation at the corresponding point.

[0091] In some embodiments, the control method performs the following steps in sequence:

[0092] S101: In the second mode, the pulse ablation device stimulates the second electrode 41 to send multiple stimulation signals in multiple directions, and each first electrode 2 collects feedback signals. The control device identifies the number of the first electrode 2 corresponding to the feedback signal that meets the second set condition, and the position of the first electrode 2 with the number is the sufficient contact part (conversely, the first electrode 2 that does not meet the second set condition can be identified as the insufficient contact part, which can be freely set according to actual use needs).

[0093] S102 : adjusting the posture of the main body component 1 , wherein the main body component 1 is deformable and the first electrode 2 is provided on the main body component 1 .

[0094] S103: Repeat S101 and S102 until the feedback signals collected by the first electrodes 2 all meet the second set condition, indicating that all the areas where the first electrodes 2 are not sufficiently attached have been eliminated.

[0095] S110: The pulse ablation device excites all first electrodes 2 in the first mode to form a closed annular electric field around the main body component, and performs circumferential overall ablation.

[0096] The second set condition may be that the feedback signal is not less than a set threshold.

[0097] At this time, before the overall ablation, the degree of fit between the balloon and the first electrodes 2 and the tissue can be detected with the aid of the feedback signal of the first electrodes 2 to ensure the fit between the first electrodes 2 and the tissue.

[0098] In some embodiments, the control method performs the following steps in sequence:

[0099] S110: The pulse ablation device excites all first electrodes 2 in the first mode to form a closed annular electric field around the main body component to perform circumferential overall ablation.

[0100] S120: In the second mode, the pulse ablation device stimulates the second electrode 41 to send multiple stimulation signals in multiple directions, each first electrode 2 collects feedback signals, the control device collects feedback signals, the control device identifies that the feedback signal that meets the first set condition contains the induced signal, identifies the number of the first electrode 2 corresponding to the received induced signal, and the position of the first electrode 2 with this number is the insufficiently ablated part.

[0101] S130: Taking the first electrode 2 with the number as the reference electrode, stimulating the reference electrode and its adjacent first electrodes or stimulating only the first electrodes on both sides of the reference electrode in the first mode, and performing supplementary ablation on the insufficiently ablated area.

[0102] At this point, the above steps can automatically complete the overall ablation, ablation effect verification, and supplementary ablation in sequence to ensure surgical efficiency.

[0103] In addition, the present invention also provides a control module for a pulse ablation device, which can be specifically applied to the pulse ablation device in the above embodiment, for example, can be set in the control device of the pulse ablation device, and can be used to implement the control method in the above embodiment.

[0104] The control device includes a high-voltage pulse transmitter 9 and a low-voltage stimulator 10, and is used to control the operation of the pulse ablation device after the second electrode 41 and the first electrode 2 are placed at different locations, wherein the operation mode of the pulse ablation device includes a first mode and a second mode;

[0105] In the first mode, the high-voltage pulse transmitter 9 is controlled to excite at least two first electrodes 2, wherein the two adjacent first electrodes 2 excited have opposite polarities, and a pulsed ablation electric field is formed between the excited first electrodes 2, and an ablation area is generated by the ablation electric field;

[0106] In the second mode, the low-voltage stimulator 10 is controlled to stimulate and send a stimulation signal for inducing a feedback signal to the second electrode 41, and the feedback signal is collected through multiple first electrodes 2. The feedback signal that meets the first set condition is identified as containing an induced signal, and the number of the corresponding first electrode 2 containing the induced signal is identified. The position of the first electrode 2 with this number is the area where ablation is insufficient.

[0107] In some embodiments, the control device comprises:

[0108] The position detection unit is used to enter the second mode and stimulate the second electrode 41 to send multiple stimulation signals in multiple directions, collect feedback signals through each first electrode 2, and identify the number of the first electrode 2 corresponding to the feedback signal that meets the second set condition.

[0109] The second setting condition may be that the feedback signal is greater than a set threshold. The position of the first electrode 2 identified above is a sufficiently close position, and the posture of the main body 1 can be adjusted to adjust the close contact between the first electrode 2 and the tissue.

[0110] Among them, when there is a feedback signal that meets the second set condition, the position detection unit repeats the detection, which can be manually instructed or automatically repeated, for example, automatically performed once every period of time, until it detects that the feedback signal of each first electrode 2 meets the second set condition. At this time, it is determined that all insufficiently attached parts have been eliminated and the overall ablation stage can be entered.

[0111] In some embodiments, the control device comprises:

[0112] A first ablation unit, configured to enter a first mode, stimulate all first electrodes 2 to perform circumferential overall ablation, and drive a detection unit;

[0113] The detection unit is used to enter the second mode, stimulate each second electrode 41 to send multiple stimulation signals in multiple directions, collect feedback signals through each first electrode 2, identify that the feedback signal that meets the first setting condition contains the induced signal, and identify the number of the first electrode 2 corresponding to the induced signal. The first setting condition can be: the feedback signal is greater than the first threshold, and / or the first-order derivative corresponding to the feedback signal is greater than the second threshold, driving the second ablation unit.

[0114] The second ablation unit identifies the numbered first electrode 2 as the reference electrode, enters the first mode, and excites the reference electrode and its adjacent first electrode or only excites the first electrodes on both sides of the reference electrode, thereby performing supplementary ablation on the insufficiently ablated area.

[0115] It should be noted that when an element is referred to as being "fixed" to another element, it may be directly attached to the other element or there may be an intermediate element. When an element is referred to as being "connected" to another element, it may be directly connected to the other element or there may be an intermediate element. In addition, in the description of the present invention, unless otherwise specified, "plurality," "plurality," and "plurality of groups" mean two or more.

[0116] Terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" indicate positions or locations based on those shown in the accompanying drawings. These terms are intended solely to facilitate and simplify the description of the present invention and are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the technical features referred to.

[0117] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in this specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0118] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0119] The pulse ablation device, its control module and control method provided by the present invention are introduced in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. It should be pointed out that for ordinary technicians in this technical field, without departing from the principles of the present invention, the present invention can also be improved and modified in several ways, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. A pulse ablation device, characterized in that: include: An expandable component comprising a conducting cavity (31), a deformable main body component, and a plurality of first electrodes (2) distributed circumferentially on a surface of the main body component; a flexible tube (4), the distal end of the flexible tube (4) extending from the distal end of the conduction cavity (31), a plurality of second electrodes (41) being provided on the flexible tube (4), the second electrodes (41) being axially separated from the first electrode (2); A control device, the control device comprising a high-voltage pulse transmitter (9) and a low-voltage stimulator (10); the high-voltage pulse transmitter (9) is connected to at least two of the first electrodes (2) to form a pulsed electric field between the first electrodes (2); When the high-voltage pulse transmitter (9) is disconnected from the first electrode (2), the low-voltage stimulator (10) is connected to the second electrode (41) to transmit a stimulation signal, and the first electrode (2) is at least used to receive an induced signal caused by the stimulation signal.

2. The pulse ablation device according to claim 1, characterized in that The main body component is a balloon (1) or a basket with a variable configuration; When the first electrode (2) is switched from being connected to the high-voltage pulse transmitter (9) to being used for detecting the induced signal, the main body component maintains a static configuration.

3. The pulse ablation device according to claim 1, characterized in that: The high-voltage pulse transmitter (9) is connected to all of the first electrodes (2) to form a closed annular electric field around the main body component, and the high-voltage pulse transmitter (9) is connected to part of the first electrodes (2) to form a non-closed arc electric field around the main body component; The first electrode (2) detects a feedback signal when the high-voltage pulse transmitter (9) is disconnected from the first electrode (2); when the low-voltage stimulator (10) is connected to the second electrode (41) to transmit a stimulation signal, the control device identifies the inclusion relationship of the feedback signal to the induced signal; and when the low-voltage stimulator (10) is disconnected from the second electrode (41), the control device identifies the electrophysiological signal included in the feedback signal; The control device further comprises a time-delay conversion component for suppressing the instantaneous conversion of the first electrode (2) from being connected to the high-voltage pulse transmitter (9) to detecting the feedback signal.

4. The pulse ablation device according to claim 1, characterized in that: The first electrode (2) detects a feedback signal when the high-voltage pulse transmitter (9) is disconnected from the first electrode (2); The control device includes a preset first threshold, and the control device identifies that the feedback signal greater than the first threshold contains the induced signal, or the control device identifies that the feedback signal whose first-order derivative is greater than the second threshold contains the induced signal.

5. The pulse ablation device according to claim 1, characterized in that: The first electrode (2) that identifies the induced signal is used as a reference electrode, and part or all of the first electrodes (2) are connected to form a pulse electric field at the location of the reference electrode, including: The reference electrode and the first electrode (2) adjacent to the reference electrode are excited by the high-voltage pulse transmitter (9) to form a pulse electric field, or the first electrodes (2) on both sides of the reference electrode are excited by the high-voltage pulse transmitter (9) to form a pulse electric field.

6. The pulse ablation device according to claim 1, characterized in that: A plurality of second electrodes (41) are distributed at the distal end of the flexible tube (4); and / or, The distal end of the flexible tube (4) is bent; and / or The distal end of the flexible tube (4) is movable and / or rotatable relative to the main body component.

7. The pulse ablation device according to claim 1, characterized in that: The first electrode (2) is in a gradient shape, an equator is formed at the maximum radial dimension of the main body component, and the first electrode (2) is partially or completely arranged on the outer surface between the distal end of the main body component and the equator.

8. The pulse ablation device according to claim 1, characterized in that: It also includes a display device (7) and a signal amplification circuit connected to the control device; when the first electrode (2) is used to detect the induced signal, the signal amplification circuit is connected to the first electrode (2); the signal amplification circuit is built into the multi-channel physiological recorder (5) or the three-dimensional electrophysiological mapping system.

9. A control method for a pulse ablation device, characterized in that: include: Expanding the main body component so that a plurality of first electrodes (2) are circumferentially distributed on the surface of the main body component, and arranging the second electrode (41) at the distal end of the main body component, with the second electrode (41) and the first electrode (2) being axially separated and arranged; The working modes of the pulse ablation device include a first mode and a second mode; In the first mode, at least two of the first electrodes (2) are excited by a high-voltage pulse transmitter (9), the two adjacent excited first electrodes (2) have opposite polarities, and a pulse ablation electric field is formed between the excited first electrodes (2); In the second mode, the second electrode (41) is stimulated by the low-voltage stimulator (10) to send a stimulation signal for causing an induced signal, a plurality of the first electrodes (2) collect feedback signals, the control device identifies that the feedback signal that meets the first set condition contains the induced signal, and the control device identifies the number of the first electrode (2) that receives the induced signal.

10. The control method according to claim 9, characterized in that: Follow these steps in order: S110: the pulse ablation device excites all the first electrodes (2) in the first mode to form a closed annular electric field surrounding the main body component; S120: the pulse ablation device stimulates the second electrode (41) to send multiple stimulation signals in multiple directions in the second mode, each of the first electrodes (2) collects a feedback signal, the control device identifies that the feedback signal that meets the first set condition contains the induced signal, and the control device identifies the number of the first electrode (2) that receives the induced signal; S130: Taking the first electrode (2) with the number as the reference electrode, stimulating the reference electrode and its adjacent first electrodes or stimulating only the first electrodes on both sides of the reference electrode in the first mode.

11. The control method according to claim 9, characterized in that: Follow these steps in order: S101: the pulse ablation device stimulates the second electrode (41) in the second mode to send multiple stimulation signals in multiple directions, each of the first electrodes (2) collects feedback signals, and the control device identifies the feedback signals that meet the second set condition; S102: adjusting the posture of the main body component, wherein the main body component is deformable; S103: Repeat S101 and S102 until the feedback signals collected by each of the first electrodes (2) meet the second set condition; S110: The pulse ablation device excites all the first electrodes (2) in the first mode to form a closed annular electric field surrounding the main body component.

12. A control module for a pulse ablation device, characterized in that: include: A control device, comprising a high-voltage pulse transmitter (9) and a low-voltage stimulator (10), for controlling the operation of the pulse ablation device according to any one of claims 1 to 8, wherein the operation mode of the pulse ablation device comprises a first mode and a second mode; In the first mode, the high-voltage pulse transmitter (9) is controlled to excite at least two of the first electrodes (2), wherein the two adjacent excited first electrodes (2) have opposite polarities, and a pulse ablation electric field is formed between the excited first electrodes (2); In the second mode, the low-voltage stimulator (10) is controlled to stimulate and send a stimulation signal to the second electrode (41), feedback signals are collected through a plurality of the first electrodes (2), feedback signals that meet the first set condition are identified as containing an induced signal, and the number of the first electrode (2) containing the induced signal is identified.

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