A pulse ablation device and control module and control method thereof

Abstract

The application discloses a kind of pulse ablation device and its control module and control method, it is related to medical equipment technical field.Pulse ablation device includes: expandable component, including multiple first electrode;Flexible pipe, several second electrodes are arranged thereon, and second electrode is arranged axially separated from first electrode;Control device includes high-voltage pulse emitter and low-voltage stimulator;High-voltage pulse emitter is communicated with at least two first electrodes, to form pulse electric field between first electrode;When high-voltage pulse emitter is disconnected with first electrode, low-voltage stimulator is communicated with second electrode to emit stimulation signal, and first electrode is at least used to receive induced signal caused by stimulation signal.The device has ablation operation and effect verification function, can reduce the placement or adjustment step of device in human body, first electrode has multiple, can be used for fixed point judgment isolation effect, so as to improve the efficiency, pertinence and safety of ablation operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a pulse ablation device, its control module, and control method. Background Technology

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

[0003] Among patients who have undergone pulmonary vein ablation procedures (e.g., radiofrequency ablation, cryoablation, and pulsed ablation), the recurrence rate of atrial fibrillation remains high. Incomplete pulmonary vein isolation and incomplete blockage of abnormal electrical signal conduction pathways are considered the most significant factors contributing to atrial fibrillation failure or recurrence. Therefore, after the planned ablation procedure, assessing the completeness of pulmonary vein isolation, identifying areas with insufficient ablation, and performing supplementary ablation on unisolated sites are crucial for improving the success rate of ablation procedures.

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

[0005] However, when isolation is incomplete, this method cannot accurately determine the exact location where electrical conduction is not interrupted. As a result, when performing supplementary ablation, it is often necessary to perform supplementary ablation on all points around the pulmonary vein, which leads to problems such as long processing time, large discharge volume, increased patient discomfort, and increased risk of hemolysis.

[0006] Furthermore, current ablation devices and ablation effect verification are usually carried out by two completely independent devices, and the devices are not related to each other. It is difficult to directly obtain the location that needs to be ablated or to convey the corresponding location information to the ablation device during the ablation effect verification.

[0007] Therefore, improving the efficiency, targeting, and safety of ablation surgery is a technical problem that needs to be solved by those skilled in the art. Summary of the Invention

[0008] In view of this, the purpose of the present invention is to provide a pulse ablation device, its control module and control method, which has high efficiency, specificity and safety in ablation surgery.

[0009] To achieve the above objectives, the present invention provides the following technical solution:

[0010] A pulse ablation device includes: an expandable component comprising a conductive cavity, a deformable main body component, and a plurality of first electrodes circumferentially distributed on the surface of the main body component; a flexible tube, the distal end of which extends from the distal end of the conductive cavity, and a plurality of second electrodes disposed on the flexible tube, the second electrodes being axially separated from the first electrodes; and a control device comprising a high-voltage pulse transmitter and a low-voltage stimulator; the high-voltage pulse transmitter being 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 electrodes, the low-voltage stimulator is connected to the second electrodes to emit a stimulation signal, and the first electrodes are at least used to receive an evoked signal caused by the stimulation signal.

[0011] In some embodiments, the main component is a variable-configuration balloon or basket; when the first electrode is switched from being connected to the high-voltage pulse transmitter to being used for detecting the induced signal, the main 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 ring electric field around the main body component, and the high-voltage pulse transmitter is connected to a portion of the first electrodes to form a non-closed arc-shaped 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; when the low-voltage stimulator is connected to the second electrode to emit a stimulation signal, the control device identifies the inclusion relationship of the feedback signal to the evoked signal; when the low-voltage stimulator is disconnected from the second electrode, the control device identifies the electrophysiological signal included in the feedback signal; the control device further includes a time-delay switching component to suppress the instantaneous switching of the first electrode 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, 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 with a first derivative greater than the second threshold contains the induced signal.

[0014] In some embodiments, a pulsed electric field is formed at the location of the reference electrode by connecting a portion or all of the first electrodes, using the first electrode that identifies the induced signal as a reference electrode. This includes: the reference electrode and the first electrode adjacent to the reference electrode being excited by the high-voltage pulse transmitter to form a pulsed electric field, or the first electrodes on both sides of the reference electrode being excited by the high-voltage pulse transmitter to form a pulsed electric field.

[0015] In some embodiments, a plurality of 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, the equator is formed at the maximum radial dimension of the main body component, and the first electrode is partially or wholly disposed on the outer surface of the main body component between the distal end and the equator.

[0017] In some embodiments, a display device and a signal amplification circuit connected to the control device are also included; when the first electrode is used to detect the evoked signal, the signal amplification circuit is connected to the first electrode; the signal amplification circuit is integrated into a multichannel physiological recorder or a three-dimensional electrophysiological mapping system.

[0018] In another aspect, this application also provides a control method for a pulse ablation device, comprising: expanding a main body component to distribute a plurality of first electrodes circumferentially on the surface of the main body component, and placing a second electrode at the distal end of the main body component, wherein the second electrode is axially separated from the first electrodes; the operating 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 are excited by a high-voltage pulse transmitter, and adjacent first electrodes being excited have opposite polarities, forming a pulse ablation electric field between each of the excited first electrodes; in the second mode, the second electrode is excited by a low-voltage stimulator to send a stimulation signal for inducing an induced signal, the plurality of first electrodes collect feedback signals, a control device identifies that a feedback signal satisfying a first set condition contains the induced signal, and the control device identifies the number of the first electrode receiving the induced signal.

[0019] In some implementations, the following steps are performed in sequence:

[0020] S110: In the first mode, the pulse ablation device excites all the first electrodes to form a closed ring electric field around the main body component; S120: In the second mode, the pulse ablation device excites the second electrodes to send multiple stimulation signals in multiple directions, each first electrode collects 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 that receives the induced signal; S130: Using the first electrode with the number as the reference electrode, in the first mode, the reference electrode and its adjacent first electrodes or only the first electrodes on both sides of the reference electrode are excited.

[0021] In some embodiments, the following steps are performed sequentially: S101: The pulse ablation device excites the second electrode to send multiple stimulation signals in multiple directions in the second mode, and each first electrode collects feedback signals. The control device identifies feedback signals that meet the second set conditions; S102: The pose 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 first electrode meet the second set conditions; S110: The pulse ablation device excites all the first electrodes in the first mode to form a closed ring electric field around the main body component.

[0022] A third aspect of this application also provides a control module for a pulse ablation device, comprising:

[0023] A control device, comprising a high-voltage pulse transmitter and a low-voltage stimulator, is used to control the operation of the aforementioned pulse ablation device. The pulse ablation device operates in two modes: a first mode and a second mode. In the first mode, the high-voltage pulse transmitter is controlled to excite at least two first electrodes, wherein adjacent first electrodes are excited with 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 stimulation signals to the second electrodes. Feedback signals are collected through multiple first electrodes, and feedback signals that meet a first set condition are identified as containing an induced signal. The number of the first electrode containing the induced signal is then identified.

[0024] The aforementioned pulse ablation device, its control module, and control method, due to the application of pulsed electric field technology for ablation, result in the first electrode contact area itself being a weak point in the ablation region. The first and second electrodes of this invention are separated to ensure they are not placed on the same side of the ablation region, facilitating verification of the ablation effect. A high-voltage pulse transmitter is used in conjunction with the signal-emitting first electrode to perform the ablation procedure. During ablation effect verification, a low-voltage stimulator, in conjunction with the second electrode, provides a stimulation signal. The first electrode can be switched to a receiving end to receive the induced signal caused by the stimulation signal at the weak point. If the induced signal is received, it indicates that the weak point constitutes an insufficiently ablated area. Therefore, the corresponding first electrode is independently re-stimulated around the weak point to conveniently achieve a continuously closed ablation site, thus achieving the treatment objective more predictably. The ablation device of this invention combines ablation function and ablation effect verification function. It can directly identify the location of insufficient ablation without changing the device's position in the patient's body after ablation, and transmit the information to the control device for targeted supplementary ablation. Overall ablation, effect verification, and supplementary ablation can be performed continuously, reducing the steps of device placement or adjustment in the human body. The structure is simplified and the operation is easy, improving the efficiency of the operation and effectively avoiding the risk of hemolysis caused by over-ablation. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

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

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

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

[0030] Figure 5 A comparative schematic diagram of the stimulation signal and feedback signal of the pulse ablation device provided in a specific embodiment of the present invention;

[0031] Figure 6 A flowchart illustrating the control method of the pulse ablation device according to a specific embodiment of the present invention.

[0032] Figure label:

[0033] Balloon 1, first electrode 2, flexible tube 4, second electrode 41, catheter 3, communication cavity 31, multichannel 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 Implementation

[0034] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] To enable those skilled in the art to better understand the present invention, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. In the specific embodiments, the distal end refers to the portion of the corresponding component farther from the surgeon, typically the end where the component enters the patient's body or surgical area. The proximal end is the portion of the corresponding component closer to the surgeon, typically the end held or manipulated by the surgeon. For a single component, the end closer to the surgeon is the proximal end, and the end farther from the surgeon is the distal end. Furthermore, in this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," "fixing," and "communication" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium; or a communication between the internal components of two elements. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0036] The core of this invention is to provide a pulse ablation device, its control module, and control method, which results in ablation surgery with high efficiency, specificity, and safety.

[0037] In a first aspect, the present invention provides a pulse ablation device, please refer to [reference needed]. Figures 1 to 4 This includes expandable components, flexible tubing 4, and control devices. For example... Figure 2 and Figure 3 As shown, the expandable component includes a conductive cavity 31, a deformable main body component 1, and a plurality of first electrodes 2 circumferentially distributed on the surface of the main body component 1. The distal end of the flexible tube 4 extends from the distal end of the conductive cavity 31, which is a channel opened inside the conduit 3 for the flexible tube 4 to pass through. The main body component 1 is connected to the distal end of the conduit 3. A plurality of second electrodes 41 are provided on the flexible tube 4, and the second electrodes 41 are axially separated from the first electrodes 2 for attaching to different locations. A control device is included, 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 electrodes 2, the low-voltage stimulator 10 is connected to the second electrodes 41 to emit a stimulation signal, and the first electrodes 2 are at least used to receive the evoked signal caused by the stimulation signal.

[0038] The pulse ablation device in this embodiment utilizes pulsed electric field technology for ablation, forming an ablation area without relying on contact between the first electrode 2 and the area to be ablated. Furthermore, because the pulsed electric field technology has a stronger electric field intensity between the first electrodes 2 than in the area where the first electrodes 2 are in contact, areas of insufficient ablation are more easily formed in the area where the first electrodes 2 are in contact. Moreover, since there are multiple first electrodes 2, feedback signals can be obtained from different points for targeted assessment of the isolation effect. By directly analyzing the induced signals received by each first electrode 2, the location of insufficient ablation can be determined. This eliminates the need for doctors to manually and frequently locate each point, emit stimulation signals, and receive induced signals to check for closure of the ablation area. Instead, if the ablation area is not continuously closed, further feedback can be directly provided to the insufficiently ablated areas.

[0039] Meanwhile, by using the separated arrangement of the second electrode 41 and the first electrode 2, it is ensured that they are not placed on the same side of the ablation area. This requires the transmission path from the second electrode 41 to the first electrode 2 to cross the ablation boundary. For example, the first electrode 2 is attached to the pulmonary vein or the vestibule (located on one side of the ablation area), and the second electrode 41 is attached to the pulmonary vein (directly located 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 myocardial cells of the pulmonary vein, verifying that there is an uninterrupted point at the first electrode 2.

[0040] Overall, the high-voltage pulse transmitter 9 works in conjunction with the first electrode 2, which can emit signals, to perform ablation surgery. When verifying the ablation effect, the low-voltage stimulator 10 works in conjunction with the second electrode 41 to provide stimulation signals. The first electrode 2 can be switched to the receiving end. The ablation effect can be verified by using the information carried by the feedback signal. This allows the device to perform both ablation surgery and effect verification. Furthermore, overall ablation, effect verification, and supplementary ablation can be performed continuously, reducing the steps of placing or adjusting the device on the human body. Since there are multiple first electrodes 2, feedback signals can be obtained from different points to determine the isolation effect at specific locations, thereby improving the efficiency, targeting, and safety of the ablation surgery.

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

[0042] In some embodiments, the distal end of the conduit 3 is connected to a main body component. The extension direction of the main body component in its initial state may correspond to the axial direction. The outer diameter of the main body component can be adjusted by telescoping the distal end of the conduit 3, expanding to form a spherical outer contour. The cable connected to the first electrode 2 is coiled inside the conduit. The conduit 3 is hollow to form a conductive cavity 31 for loading the flexible tube 4.

[0043] In some embodiments, such as Figure 2As shown, the main component 1 is a variable-configuration balloon. Specifically, the balloon 1 can be made of biocompatible materials such as TPU and PEBAX, and the catheter 3 is also provided with an infusion chamber communicating with the balloon 1. In other embodiments, the main component 1 can also be a variable-configuration basket, specifically achieving deformation through self-expansion properties, and can also be replaced with an expandable cage-like stent or other structures.

[0044] Specifically, during ablation surgery (whether overall ablation or supplementary ablation), balloon 1 contracts within the sheath when inserted into the blood vessel. Once it reaches the target location, balloon 1 extends out of the sheath and is inflated with gas / liquid through the tubing, transforming balloon 1 from a contracted state into a full sphere. In its inflated state, balloon 1 can be positioned at the pulmonary vein orifice, resulting in good positioning.

[0045] In some embodiments, since the electric field strength of the PFA (Pulsed Field Ablation) electric field pair is lower at the electrode sites, these sites are more likely to be areas of insufficient ablation. In some embodiments, during the transition of 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 during the overall ablation transition to ablation effect verification, the balloon 1 and the first electrode 2 remain stably in place. If an area of ​​insufficient ablation is identified, the ablation intensity at that location can be strengthened by selectively stimulating a portion of the first electrode 2, i.e., supplementary ablation is performed in the corresponding first electrode region, rather than blindly stimulating all of the first electrodes 2 multiple times to form an over-ablation ablation zone. Of course, in other embodiments, the balloon 1 can be rotated after identifying an insufficient location for selective supplementary ablation.

[0046] In some embodiments, the first electrode 2 is a flexible electrode, which is positioned and attached to the outer surface of the balloon 1 and can adapt to the deformable main body component 1. Exemplarily, the first electrode 2 uses a bottom substrate such as polyimide / polyester as a base, and conductive copper foil is connected to the bottom substrate with the help of an adhesive. The surface of the conductive copper foil is treated with immersion gold 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, multiple first electrodes 2 are arranged sequentially along the circumference on the outside of the balloon 1, specifically in a uniform circumferential arrangement.

[0048] In some embodiments, such as Figure 2 and Figure 3 As shown, the first electrode 2 has a gradient shape, such as a cone or teardrop shape. Compared with an electrode structure of uniform width, this first electrode 2 can increase the overall flexibility of the electrode when it is retracted into the sheath, avoiding problems such as poor adhesion and edge lifting caused by different material hardness and excessively large electrodes.

[0049] Furthermore, based on biological anatomy, the size of the pulmonary vein orifice varies considerably among different populations; for example, such as... Figure 2 and Figure 3 As shown, the equator is formed at the maximum radial dimension of the balloon 1. The first electrode 2 is partially or entirely disposed on the outer surface of the main body 1 between the distal end and the equator. At this time, the part of the first electrode 2 that contacts the tissue generally covers the anterior hemisphere of the balloon 1, that is, the side near the distal end, which can accommodate pulmonary veins of different sizes and ensure that the first electrode 2 has a certain contact area with the tissue radially. It is set in a gradually changing shape, wider at the proximal end and narrower at the distal end, so as to ensure the spacing between the two first electrodes and improve the uniformity of the pulse electric field distribution on the periphery of the main body.

[0050] In some embodiments, the flexible tube 4 extends from the distal end of the conductive 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, such as Figure 3 As shown, multiple 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. For example, refer to Figure 3 The distal end of the flexible tube 4 can be bent into a ring shape. Along this section, the second electrodes 41 are arranged circumferentially, spaced apart and evenly, so that each second electrode 41 forms a ring tightly against the pulmonary vein cavity, providing a generally circumferentially distributed stimulation signal. Alternatively, the distal end of the flexible tube 4 can also be bent into an arc shape, a spiral shape, or other similar shapes. Furthermore, the second electrodes 41 are electrode rings, which are fitted 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, thus ensuring that the emitted stimulation signal is multidirectional. This reduces the number of adjustments needed to the contact position of the second electrodes 41 with the pulmonary vein cavity. Combined with the rotation of the flexible tube 4, this ensures that a sufficient number of stimulation signals from various directions are propagated towards the ablation site, improving the sufficiency and accuracy of the feedback signals received by each first electrode 2, and avoiding the misjudgment of insufficiently ablated areas as fully ablated areas.

[0053] In some embodiments, such as Figure 3As shown, the distal end of the flexible tube 4 is fixed relative to the main body component 1, ensuring that the flexible tube 4 can be stably positioned in the pulmonary vein during the ablation procedure. Of course, in other embodiments, the distal end of the flexible tube 4 can be movable and / or rotated relative to the main body component 1 to further expand the points accessible to 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 component 1 can specifically mean that the entire flexible tube 4 can move within the conductive cavity 31, or that only the distal region on the flexible tube 4 can move accordingly under the control of an externally controlled electronic component.

[0054] In control devices, 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 or communicatively connected to the control host 8 and are uniformly controlled by the control host 8, such as controlling the on / off state. Specifically, the high-voltage pulse transmitter 9 is connected to the first electrode 2, which can be achieved through a wire or other electrical connector. The low-voltage stimulator 10 is connected to the second electrode 41, which can also be achieved through a wire or other electrical connector.

[0055] During the ablation procedure (both overall ablation and supplementary ablation), the high-voltage pulse transmitter 9 is connected to the first electrode 2, with each first electrode 2 serving as a transmitter. When connected, the high-voltage pulse transmitter 9 can provide several watts (W) of energy to each first electrode 2 individually. Adjacent first electrodes 2 can alternately discharge in the same or opposite directions (+-+- or ++--), and the high-voltage pulse transmitter 9 can control the discharge of any pair or more electrodes. The two first electrodes 2 in each pair have opposite polarities. During ablation, any adjacent first electrodes 2 can serve as electrode pairs during the discharge treatment process, and the control unit 8 can flexibly control which pair or pairs of first electrodes 2 will perform 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 ring electric field around the main component, and the high-voltage pulse transmitter 9 is connected to a portion of the first electrodes 2 to form a non-closed arc electric field around the main component. Specifically, in operation, the high-voltage pulse transmitter 9 is connected to all of the first electrodes 2 to form a closed ring electric field around the main component for overall ablation before verifying the ablation effect of the ablation surgery; supplementary ablation after verifying the ablation effect includes the high-voltage pulse transmitter 9 being connected to a portion of the first electrodes 2 to form a non-closed arc electric field around the main 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 added to the closed ring electric field, which is beneficial for forming a continuous closed ablation area with an appropriate ablation depth on the outer periphery of the main 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 emit a stimulation signal, the control device identifies the inclusion relationship between the feedback signal and the induced signal. The first electrode 2 can be used to detect the feedback signal to verify the attachment of the main 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 the ablation surgery, primarily before the overall ablation. This allows the first electrode 2 to be inserted into 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, balloon 1 is inserted into the pulmonary vein opening, and the first electrode 2 is placed against the predetermined position of the tissue to be tested. The first electrode 2 receives the myocardial signal as a feedback signal. If one (or more) of the first electrodes 2 does not receive a feedback signal or receives a predetermined weak signal (after the timing of the emitted stimulation signal, the amplitude of the received signal attenuates significantly and the signal-to-noise ratio increases), such as the signal voltage amplitude of the myocardial cells received by the first electrode 2 being only 0-20% of the voltage amplitude of the stimulation signal itself, it indicates that the first electrode 2 at this (or more) position is not fully attached or is not in place. In some other embodiments, the stability of attachment can also be identified by observing the impedance value and the change in contact force. The operator needs to adjust the position of balloon 1. It is preferable to adjust all first electrodes 2 until they are all in contact with the tissue before stimulating all first electrodes 2 as a whole. This ensures that the overall ablation of the whole stimulation has a good adhesion and ablation effect, reducing the number and complexity of subsequent supplementary ablation. Specifically, the second electrode 41 resends the stimulation signal and repeats the above steps of first electrode 2 detection and balloon 1 adjustment until all first electrodes 2 successfully receive the set correct feedback signal, achieving the effect of each first electrode 2 being completely in contact with the pulmonary vein orifice (or vestibule).

[0060] Verification of the ablation effect of the pulsed electric field is mainly performed after overall ablation and supplementary ablation. The second electrode 41 sends a stimulation signal through the surface of the pulmonary vein, and the first electrode 2 receives the feedback signal; if none of the first electrodes 2 receives a signal or receives a set weak signal, the pulmonary vein can be considered successfully isolated, and the corresponding first electrode 2 ablation is considered complete.

[0061] In some embodiments, when the first electrode 2 is disconnected from the high-voltage pulse transmitter 9, the first electrode 2 detects a feedback signal. 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. When the second electrode 41 is disconnected from the low-voltage stimulator 10, the electrophysiological signal collected does not depend on the output of the stimulation signal, but directly collects the electrocardiogram signal information directly at the attached site (used to display the potential of the attached site or to observe whether the first electrode 2 can be powered on normally).

[0062] In some embodiments, the control device further includes a delay switching component for suppressing the instantaneous switching of the first electrode 2 from being connected to the high-voltage pulse transmitter 9 to the detection feedback signal, i.e., the switching of the first electrode 2 from the transmission mode to the reception mode, by delaying the switching to avoid interference between the transmission signal and the reception signal. Optionally, the delay switching component can specifically be an electronic circuit in the control host 8, such as a digital delay circuit.

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

[0064] Because some balloons 1 typically inject a non-ionizing contrast agent into the anterior segment, or because balloon 1 blocks blood vessels causing blood to fill the distal part of the main body, the exposed portion of the anterior part of the first electrode 2 of balloon 1 may be exposed in the pulmonary vein. The stimulation signal released by the second electrode 41 will be transmitted to the first electrode 2 through the mixture of blood and contrast agent. In this case, the first electrode 2 may correspondingly acquire a very weak stimulation signal transmitted through the liquid. If the feedback signal only includes this type of signal, refer to... Figure 5 In fact, point ② cannot reflect the problem of insufficient isolation.

[0065] Based on this, in some embodiments, the control device includes a preset first threshold, identifies and determines that feedback signals greater than the first threshold contain the inducing signal, selects a first electrode 2 with feedback signals greater than the first threshold as a reference electrode, and the location of the reference electrode is a site of insufficient ablation, serving as a point for supplementary ablation surgery. The feedback signal is an electrical signal, and the first threshold is a set specific voltage value.

[0066] At this point, by setting a first threshold, feedback signals that include only weak stimulation signals transmitted by the liquid are excluded. Figure 5 In case ②, if the feedback signal collected by the first electrode 2 is lower than the first threshold set by the control device, the isolation is considered sufficient; if the feedback signal collected by the first electrode 2 is higher than the first threshold, 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 judging the ablation effect.

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

[0068] Based on this, to improve the accuracy of ablation effect assessment, the near-field signal can be distinguished according to its shape, given its relatively flat far-field signal and relatively sharp near-field signal, to obtain information about the near-field signal. Specifically, in some embodiments, the control device includes a preset second threshold, identifies and determines that the feedback signal with a first derivative greater than the second threshold contains the induced signal, and selects the first electrode 2 corresponding to the feedback signal with a first derivative greater than the second threshold as the reference electrode. The location of the reference electrode is the area of ​​insufficient ablation, thereby more accurately reflecting the ablation effect.

[0069] The aforementioned first threshold and second threshold are related over time. Both can be preset, fixed parameter values ​​or proportional values ​​relative to the stimulus signal parameters. For example, if the amplitude or first derivative of the collected feedback signal is set to be 20% lower than the amplitude or first derivative of the stimulus signal, it can be said that the area is a sufficiently ablated area. Conversely, if the amplitude or first derivative of the collected signal is higher, it indicates that the area is an insufficiently ablated area.

[0070] During supplementary ablation, that is, when performing a second ablation operation on areas where ablation was insufficient after verification of ablation effect, the process may include: using the first electrode 2 that detected the induced signal as the reference electrode, performing supplementary ablation on the location of the reference electrode. 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 energy intensity that can be adjusted accordingly as the distance increases) are excited by the high-voltage pulse transmitter 9 to form a pulsed electric field, thereby achieving precise re-ablation of the insufficiently ablated location or area.

[0071] Specifically, after determining the insufficiently isolated points based on the ablation effect verification, the control host 8 can automatically make decisions or recommend supplementary ablation plans to the operator. For example, the first electrode 2 at that point and the most suitable adjacent first electrode 2 can be used as discharge targets to automatically perform supplementary discharge ablation. Alternatively, after the control host 8 prompts or displays the ablation effect verification and indicates the location of the insufficiently isolated electrode to the operator, the operator can decide on the supplementary ablation method and re-emit the first electrode 2 based on experience.

[0072] To facilitate determining the progress of the surgery, such as 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 the control host 8. The display device 7 can be used to display the surgical progress, including the ablation procedure, verification of the ablation effect, and the process of supplementary ablation. The signal amplification circuit can be used to amplify the feedback signal of the first electrode 2.

[0073] In some embodiments, the display device 7 and the signal amplification circuit are integrated into the multichannel physiological recorder 5 or the three-dimensional electrophysiological mapping system, specifically a three-dimensional cardiac electrophysiological mapping system; or, the signal amplification circuit is integrated into the multichannel physiological recorder 5 or the three-dimensional electrophysiological mapping system. The display device 7, as a separate device, is electrically connected to a control device for displaying patient information, the current surgical stage, relevant parameters of the ablation effect, and recommended operator implementation plans, etc.

[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 the feedback signal, the signal amplification circuit can amplify the feedback signal received by the first electrode 2. The function of recording or displaying electrophysiological signals can be used with the help of a multichannel physiological recorder 5 or a three-dimensional electrophysiological mapping system to conveniently realize the display or analysis of the ablation effect.

[0075] The pulse ablation device in this embodiment operates on the following principle:

[0076] Overall ablation: The first electrode 2 is attached to the pulmonary vein orifice or vestibule, and the second electrode 41 is attached to the pulmonary vein. The high-voltage pulse transmitter 9 excites all the first electrodes 2 to perform circumferential overall ablation.

[0077] Ablation effect verification: 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 the isolation is incomplete are determined.

[0078] Supplementary ablation: When the ablation effect verification shows that the pulmonary vein isolation at one or more first electrodes is incomplete, supplementary ablation is required. Supplementary discharge electric field ablation is performed on the electrode pairs at the corresponding points. If only a single first electrode 2 receives a feedback signal corresponding to the incomplete isolation information, then this single first electrode 2 is used as the reference electrode. The reference electrode can be selected to form an electrode pair with any one of the first electrodes 2 on both sides, and supplementary discharge treatment is performed until the first electrode 2 in that area no longer receives the stimulation signal emitted by the second electrode 41. At this point, the pulmonary vein has been successfully completely isolated. It is understandable that, in addition to identifying a single electrode indicating insufficient ablation at that contact point, the same principle applies to identifying feedback signals containing induced signals received by two first electrodes 2. In this case, both first electrodes 2 can serve 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 aforementioned scheme. In addition to supplementary ablation, the overall ablation intensity can be compensated for by adding pulse counts, or by readjusting the contact degree and contact position to obtain a better ablation effect and improve ablation efficiency.

[0079] In addition to the aforementioned pulse ablation device, the present invention also provides a control method for using the aforementioned pulse ablation device, the control method comprising the following steps:

[0080] The expansion of the main body component causes multiple first electrodes 2 to be circumferentially distributed on the surface of the main body component, and the second electrode 41 is disposed at the far end of the main body component, with the second electrode 41 being axially separated from the first electrode 2.

[0081] The pulse ablation device has two operating modes: a first mode and a second mode.

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

[0083] In the second mode, the second electrode 41 is excited by the low-pressure stimulator 10 to send a stimulation signal to induce an evoked signal. Multiple first electrodes 2 collect feedback signals. The control device identifies that the feedback signal that meets the first set condition contains the evoked 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 evoked signal. The location of the first electrode 2 with this number is the area of ​​insufficient ablation.

[0084] The first set condition can be: the feedback signal is greater than the first threshold, and / or the first derivative of the feedback signal is greater than the second threshold.

[0085] Based on the above steps, by recognizing feedback signals that meet the first set conditions, the location of incomplete isolation or insufficient ablation can be automatically identified, thereby improving the automation and efficiency of the ablation procedure.

[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 diagram, solid arrows indicate a connected state, while dashed arrows indicate a disconnected state.

[0087] In the first mode, the high-voltage pulse transmitter 9 is connected to at least two first electrodes 2 to form a pulsed electric field between the first electrodes 2. This mode is for performing ablation surgery, including surgical treatment of overall ablation or supplementary ablation. Specifically, the tip of the first electrode 2 is closely attached to 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 electrode 2 through a cable, forming a pulsed electric field between the first electrodes 2. The high-voltage pulse clamps the potential across the cell membrane, causing cell inactivation and apoptosis, thus 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 emit a stimulation signal. The first electrode 2 is used to detect the evoked signal caused by the stimulation signal.

[0089] It should be noted that when the first electrode 2 receives a feedback signal, it may not receive a signal, or it may only receive a weak stimulation signal transmitted to the first electrode 2 through the blood flow mixed with contrast agent in the blood vessels. In these two cases, the isolation may be considered complete or thorough. It is also possible that the feedback signal received may include the electrical signal generated by the excitation of myocardial cells upon receiving the stimulation signal (i.e., the evoked signal). This situation is usually considered as non-isolation or incomplete isolation.

[0090] For details, please refer to the following: Figure 5The three signal comparison diagrams in ①, ②, and ③ show time on the horizontal axis and signal amplitude on the vertical axis. The second electrode 41 extends to the distal end of the pulmonary vein orifice (at a certain distance from the pulmonary vein orifice), and the first electrode 2 is positioned near the pulmonary vein orifice. The second electrode 41 emits a stimulation signal towards the position it contacts. ① is the image of the stimulation signal. The first electrode 2 is used to receive the feedback signal. When the corresponding image is ②, it only includes a weak stimulation signal (signal amplitude significantly reduced), which is considered sufficient isolation, and the corresponding point does not need additional ablation. When the corresponding image is ③, it includes myocardial signals and a weak stimulation signal. Further analysis is needed to determine whether the first derivative of the myocardial signal meets the constraint of the second threshold. If the myocardial signal in ③ is relatively blunt and the amplitude is significantly reduced, and it has a transmission relationship with the far-field electrocardiogram signal, it can be considered sufficient isolation, and the corresponding point does not need additional ablation.

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

[0092] S101: In the second mode, the pulse ablation device excites the second electrode 41 to send multiple stimulation signals in multiple directions. 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 takes the position of the first electrode 2 with the number as 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 the actual use needs).

[0093] S102: Adjust the position of the main body component 1, wherein the main body component 1 is deformable and the first electrode 2 is disposed on the main body component 1.

[0094] S103: Repeat S101 and S102 until the feedback signals collected by each of the first electrodes 2 meet the second set condition, indicating that all insufficient contact areas of the first electrodes 2 have been eliminated.

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

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

[0097] At this point, before overall ablation, the feedback signal from the first electrode 2 can be used to detect the degree of adhesion between the balloon and the first electrode 2 and the tissue, so as to ensure the adhesion between each first electrode 2 and the tissue.

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

[0099] S110: In the first mode, the pulse ablation device excites all the first electrodes 2 to form a closed ring electric field around the main body component, and performs circumferential overall ablation.

[0100] S120: In the second mode, the pulse ablation device excites 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 and identifies that the feedback signal that meets the first set condition contains the induction signal. The control device identifies the number of the first electrode 2 corresponding to the received induction signal and takes the location of the first electrode 2 with the number as the part of insufficient ablation.

[0101] S130: Using the first electrode 2 of this number as the reference electrode, in the first mode, the reference electrode and its adjacent first electrodes or only the first electrodes on both sides of the reference electrode are excited to perform supplementary ablation on the insufficiently ablated areas.

[0102] At this point, the above steps can be completed in sequence to automate the overall ablation, ablation effect verification, and supplementary ablation, ensuring surgical efficiency.

[0103] Furthermore, 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 embodiments. For example, it can be set in the control device of the pulse ablation device, and can be used to implement the control method in the above embodiments.

[0104] The control device includes a high-voltage pulse transmitter 9 and a low-voltage stimulator 10, which are used to control the pulse ablation device to work after the second electrode 41 and the first electrode 2 are attached to different parts. The working modes of the pulse ablation device include 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 two adjacent first electrodes 2 that are excited have opposite polarities, and a pulse ablation electric field is formed between each of the excited first electrodes 2, and an ablation region is generated by the ablation electric field.

[0106] In the second mode, the low-pressure stimulator 10 is controlled to excite and send a stimulation signal to the second electrode 41 to induce a feedback signal. The feedback signal is collected by multiple first electrodes 2, and the feedback signal that meets the first set condition is identified as containing an induced signal. The number of the corresponding first electrode 2 containing the induced signal is identified, and the location of the first electrode 2 with the number is the area of ​​insufficient ablation.

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

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

[0109] The second setting condition can be that the feedback signal is greater than a set threshold. The location of the first electrode 2 with the identified number is a sufficiently close contact area, thereby adjusting the position of the main body component 1 to adjust the contact between the first electrode 2 and the tissue.

[0110] When a feedback signal that meets the second set condition is present, the position detection unit repeats the detection. This can be done manually or automatically, for example, automatically once every certain period of time, until a feedback signal that meets the second set condition is detected for each first electrode 2. At this point, it is determined that all insufficiently attached parts have been eliminated, and the overall ablation process can begin.

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

[0112] The first ablation unit is used to enter the first mode and stimulate all first electrodes 2 to perform circumferential overall ablation, thereby driving the detection unit;

[0113] The detection unit is used to enter the second mode, excite 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 set condition contains an induction signal, identify the number of the first electrode 2 corresponding to the induction signal, and the first set condition can be: the feedback signal is greater than the first threshold, and / or the first derivative of the feedback signal is greater than the second threshold, and drive the second ablation unit.

[0114] The second ablation unit uses the first electrode 2 with the identified number as the reference electrode, enters the first mode, and excites the reference electrode and its adjacent first electrodes or only the first electrodes on both sides of the reference electrode to supplement the ablation of the insufficiently ablated areas.

[0115] It should be noted that when an element is referred to as "fixing" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as "connecting" another element, it can be directly connected to the other element or there may be an intervening element. Furthermore, in the description of this invention, unless otherwise stated, "multiple," "multiple roots," and "multiple groups" mean two or more.

[0116] The terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the 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 number of technical features indicated.

[0117] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

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

[0119] The pulse ablation device, its control module, and control method provided by this invention have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the embodiments above are merely for the purpose of helping to understand the method and core ideas of this invention. It should be noted that those skilled in the art can make various improvements and modifications to this invention without departing from its principles, and these improvements and modifications also fall within the protection scope of the claims of this invention.

Claims

1. A pulse ablation device, characterized in that, include: The expandable component includes a conductive cavity, a deformable body component, and a plurality of first electrodes circumferentially distributed on the surface of the body component; A flexible tube, the distal end of which extends from the distal end of the conductive cavity, and a plurality of second electrodes are provided on the flexible tube, the second electrodes being axially separated from the first electrodes; A control device comprising a high-voltage pulse transmitter and a low-voltage stimulator; the high-voltage pulse transmitter being 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 emit a stimulation signal, and the first electrode is at least used to receive the evoked signal caused by the stimulation signal.

2. The pulse ablation device according to claim 1, characterized in that, The main component is a spherical balloon or a basket with a variable 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.

3. The pulse ablation device according to claim 1, characterized in that, The high-voltage pulse transmitter is connected to all of the first electrodes to form a closed ring electric field around the main body component, and the high-voltage pulse transmitter is connected to a portion of the first electrodes to form a non-closed arc electric field around the main body component; When the first electrode is disconnected from the high-voltage pulse transmitter, the first electrode detects a feedback signal. When the low-voltage stimulator is connected to the second electrode to emit a stimulation signal, the control device identifies the inclusion relationship between the feedback signal and the induced signal. When the low-voltage stimulator is disconnected from the second electrode, the control device identifies the electrophysiological signal included in the feedback signal. The control device further includes a delay conversion component that suppresses the instantaneous switching of the first electrode from being connected to the high-voltage pulse transmitter to detecting the feedback signal.

4. The pulse ablation device according to claim 1, characterized in that, 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 with a first derivative greater than a second threshold contains the induced signal.

5. The pulse ablation device according to claim 1, characterized in that, Using the first electrode that detects the induced signal as a reference electrode, a pulsed electric field is formed at the location of the reference electrode by connecting part or all of the first 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.

6. The pulse ablation device according to claim 1, characterized in that, The flexible tube has a plurality of second electrodes distributed at its distal end; 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.

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

8. The pulse ablation device according to claim 1, characterized in that, 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 multichannel physiological recorder or a three-dimensional electrophysiological mapping system.

9. A control module for a pulse ablation device, characterized in that, include: A control device, comprising a high-voltage pulse transmitter and a low-voltage stimulator, for controlling the operation of the pulse ablation device according to any one of claims 1-8, wherein the operating modes of the pulse ablation device include a first mode and a second mode; In the first mode, a high-voltage pulse transmitter is controlled to excite at least two of the first electrodes, wherein two adjacent first electrodes that are excited have opposite polarities, and a pulse ablation electric field is formed between each of the excited first electrodes. In the second mode, the low-pressure stimulator is controlled to excite and send stimulation signals to the second electrode. Feedback signals are collected through multiple first electrodes, and feedback signals that meet the first set conditions are identified as containing evoked signals. The number of the first electrode containing the evoked signal is also identified.

10. The control module according to claim 9, characterized in that, The control module is capable of executing the following steps in sequence: S110: The pulse ablation device in the first mode excites all the first electrodes to form a closed ring electric field around the main body component; S120: In the second mode, the pulse ablation device excites the second electrode to send multiple stimulation signals in multiple directions. Each first electrode collects a feedback signal. The control device identifies that the feedback signal that meets the first set condition contains the induction signal. The control device identifies the number of the first electrode that receives the induction signal. S130: Using the first electrode with this number as the reference electrode, in the first mode, the reference electrode and its adjacent first electrodes are excited, or only the first electrodes on both sides of the reference electrode are excited.

11. The control module according to claim 9, characterized in that, The control module is capable of executing the following steps in sequence: S101: In the second mode, the pulse ablation device excites the second electrode to send multiple stimulation signals in multiple directions, and each first electrode collects feedback signals. The control device identifies feedback signals that meet the second set conditions. S102: Adjust the pose of the main component, wherein the main component is deformable; S103: Repeat S101 and S102 until the feedback signals collected by each of the first electrodes meet the second set condition; S110: In the first mode, the pulse ablation device excites all the first electrodes to form a closed ring electric field around the main body component.

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