Ablation catheter, ablation system, ablation monitoring method

Abstract

This application provides an ablation catheter, an ablation system, and an ablation monitoring method. The ablation catheter includes a catheter assembly and a functional component. The catheter assembly includes a main tube and a support strip that are axially movable relative to each other. The functional component is capable of radially expanding or contracting as the support strip and the main tube move relative to each other axially. The functional component includes an ablation member, comprising at least two first mounting members, each first mounting member having at least one first electrode. Two circumferentially adjacent first mounting members form a paired support group, and a first electrode with a first polarity and a first electrode with a second polarity on the paired support group form a paired electrode group. The paired support group has at least one paired electrode group. The monitoring component includes at least one second mounting member, and at least one second mounting member has at least one first monitoring element. At least one second mounting member is arranged between two first mounting members in the at least one paired support group.

Description

Cross-reference to related applications

[0001] This application is based on and claims priority to Chinese Patent Application No. 202610413126.4, filed on March 31, 2026, entitled “Ablation Catheter and Manufacturing Method Thereof, Ablation System”, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to medical device technology, and in particular to ablation catheters, ablation systems, and ablation monitoring methods. Background Technology

[0003] Atrial fibrillation and other arrhythmias can lead to stroke, cardiomyopathy, and in severe cases, death. Pulsed field ablation (PFA) is an interventional treatment for arrhythmias that relies on the irreversible electroporation (IRE) effect to ablate myocardial tissue. In PFA, the anode and cathode electrodes are paired to create an electric field gradient within the tissue, pointing from the anode to the cathode (one of the anode and cathode electrodes can be a return electrode, or both can be located within the heart chambers). When the cell membrane of the target tissue is exposed to this electric field, the electric field energy can be used to locally ablate the target tissue.

[0004] Typically, the electric field and current density are strongest near the surface of the paired electrodes. However, the electric field strength gradually decreases in the ablation zone around the electrodes as the distance between them increases, resulting in a weaker electric field and lower current density in the central region between the paired electrodes, exhibiting an uneven electric field distribution. Therefore, in practical applications, the ablation zone between the paired electrodes may be too small or even empty, making it difficult for the electric field to completely cover the target lesion, leading to incomplete ablation of the target tissue and other adverse situations. Summary of the Invention

[0005] In some embodiments, this application provides an ablation catheter, including a longitudinally extending proximal end and a distal end. The ablation catheter further includes: a catheter assembly including a main tube and a support strip, the support strip passing through the main tube and the two being axially movable relative to each other; a functional component, the distal end of the functional component being connected to the support strip, and the proximal end of the functional component being connected to the main tube, the proximal and distal ends of the functional component being able to move closer or further apart as the support strip and the main tube move relative to each other axially, and the functional component being able to radially expand or contract; the functional component includes an ablation member and a monitoring member; the ablation member includes at least two first mounting members, each first mounting member being provided with at least one first electrode for releasing ablation energy; two circumferentially adjacent first mounting members serve as a paired support group, one of the first mounting members in the paired support group... One first electrode on the component has a first polarity, and one first electrode on another first mounting component has a second polarity. A first electrode with the first polarity and a first electrode with the second polarity on a paired support group form a paired electrode group. At least one paired electrode group is provided on the paired support group. The monitoring component includes at least one second mounting component, and at least one first monitoring component is provided on the at least one second mounting component. The first monitoring component is used to monitor the voltage signal of its area to determine the electric field strength of the area. At least one second mounting component is arranged between two first mounting components in at least one paired support group. The first mounting components and the second mounting components are distributed at circumferential intervals along the functional component. A first monitoring component on a second mounting component is correspondingly arranged between at least one paired electrode group on its paired support group.

[0006] Because the functional components can expand or contract radially, the ablation catheter occupies less space in its contracted form, making it suitable for narrow spaces and facilitating smooth entry and exit. In its expanded form, the functional components extend circumferentially, allowing them to approach the target tissue more closely. Since the paired support group contains paired electrode groups, an ablation energy field (e.g., an electric field) can be generated between the two first electrodes in the paired electrode group, enabling ablation of the target tissue. Because a second mounting member is arranged between the two first mounting members in at least one paired support group, and the second mounting member has at least one first monitoring member corresponding to the paired electrode group, the first monitoring member is located within the ablation energy field and can monitor the voltage signal of the ablation energy. This allows for determination of the range and intensity of the ablation energy field, as well as whether a preset range and intensity have been reached. Based on this determination and judgment, the user can adjust the functional components so that the target location can receive radiation from an energy field of a preset range and intensity, thereby facilitating thorough and complete ablation. Furthermore, by placing the first monitoring element between the paired electrode groups, the location with relatively low energy in the energy field (e.g., electric field) formed by the electrode groups can be monitored, thereby reflecting the intensity of the entire energy field. Specifically, if the energy field intensity (e.g., electric field intensity) at a relatively low energy location has reached a preset target intensity, the energy field intensity at other locations (e.g., the location of the first electrode) is also likely to have reached the preset target intensity. Therefore, the target tissue can be fully and thoroughly ablated.

[0007] In some embodiments, this application also provides an ablation system, comprising: an ablation catheter including a longitudinally extending proximal end and a distal end; the ablation catheter further comprising: a catheter assembly including a main tube and a support strip, the support strip passing through the main tube and the two being axially movable relative to each other; a functional component, the distal end of the functional component being connected to the support strip, the proximal end of the functional component being connected to the main tube, the proximal and distal ends of the functional component being able to move closer or further apart as the support strip and the main tube move relative to each other axially, and the functional component being able to radially expand or contract; the functional component including an ablation member and a monitoring member; the ablation member including at least two first mounting members, each first mounting member having at least one first electrode for releasing ablation energy; two circumferentially adjacent first mounting members forming a paired support group, the first electrode on one of the first mounting members of the paired support group having a first polarity, and the other... A first electrode of a first mounting member has a second polarity. A first electrode with a first polarity and a first electrode with a second polarity on a paired support group form a paired electrode group. At least one paired electrode group is provided on the paired support group. The monitoring component includes at least one second mounting member. At least one first monitoring member is provided on the at least one second mounting member for monitoring the voltage signal of its area to determine the electric field strength of the area. At least one second mounting member is arranged between two first mounting members in at least one paired support group. The first mounting members and the second mounting members are distributed at circumferential intervals along the functional component. A first monitoring member on the second mounting member is correspondingly provided on at least one paired electrode group on its paired support group. A controller is communicatively connected to the ablation catheter. The controller outputs a drive signal, which is used to cause the first electrode on the ablation catheter to release ablation energy.

[0008] In some embodiments, this application also provides an ablation monitoring method applied to an ablation catheter; the ablation catheter includes a longitudinally extending proximal end and a distal end, and further includes: a catheter assembly including a main tube and a support strip, the support strip passing through the main tube and the two being axially movable relative to each other; a functional component, the distal end of the functional component being connected to the support strip, the proximal end of the functional component being connected to the main tube, the proximal and distal ends of the functional component being able to move closer or further apart as the support strip and the main tube move relative to each other axially, and the functional component being able to radially expand or contract; the functional component includes an ablation member and a monitoring member; the ablation member includes at least two first mounting members, each first mounting member being provided with at least one first electrode for releasing ablation energy; two circumferentially adjacent first mounting members serve as a paired support group, and one of the first mounting members of the paired support group has a first electrode with a first pole. The first electrode of the first mounting member has a second polarity, and a first electrode with a first polarity and a first electrode with a second polarity on the paired support group form a paired electrode group. The paired support group is provided with at least one paired electrode group. The monitoring component includes at least one second mounting member, and at least one first monitoring member is provided on the at least one second mounting member. The first monitoring member is used to monitor the voltage signal of its area to determine the electric field strength of the area. At least one second mounting member is arranged between two first mounting members in at least one paired support group. The first mounting members and the second mounting members are distributed at circumferential intervals along the functional component. A first monitoring member on the second mounting member is correspondingly arranged between at least one paired electrode group on the paired support group where it is located. The method includes: acquiring the voltage signal detected by the target first monitoring member; if the voltage signal is greater than or equal to a preset value, outputting a first warning signal.

[0009] Because the first monitoring element is located within the ablation electric field, it can monitor the voltage signal of the ablation energy. This allows the user to determine the ablation range and intensity based on the voltage signal, thus contributing to precise and thorough ablation. The ablation monitoring method enables timely determination of whether the voltage signal meets requirements and notifies the user, facilitating prompt response and subsequent operations. Attached Figure Description

[0010] Figure 1 This is a schematic diagram of the structure of the ablation catheter, whose functional components are in a contracted state, as provided in the embodiments of this application. Figure 2 This is a schematic diagram of the structure of the ablation catheter, which presents a petal-shaped unfolding form, according to the embodiments of this application. Figure 3 This is a partial structural diagram of an ablation catheter with a cage-like unfolded shape, provided in an embodiment of this application. Figure 4This is a partial structural schematic diagram of the ablation catheter provided in an embodiment of this application, showing the location of the central meridian and the central region; Figure 5 This is a partial structural schematic diagram of an ablation catheter in which the first and second mounting components are alternately distributed along the circumference of the functional components, as provided in the embodiments of this application. Figure 6 This is a partial structural schematic diagram of the ablation catheter provided in an embodiment of this application, which shows the structure and placement of the first monitoring element; Figure 7 This is a schematic diagram showing the position of the first monitoring element in the ablation catheter provided in this embodiment of the application; Figure 8 This is a cross-sectional schematic diagram of the first monitoring element provided in the embodiments of this application; Figure 9 This is a schematic diagram showing the position of the first monitoring element in the ablation catheter provided in some embodiments of this application; Figure 10 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrode according to an embodiment of this application; Figure 11 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrodes according to another embodiment of this application; Figure 12 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrode according to another embodiment of this application; Figure 13 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrode in another embodiment of this application; Figure 14 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrode according to another embodiment of this application; Figure 15 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrodes in another embodiment of this application; Figure 16 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrode, provided in yet another embodiment of this application; Figure 17 This is a schematic diagram showing the positions of the first measuring end and the second measuring end relative to the paired electrode, provided in yet another embodiment of this application; Figure 18 This is a schematic diagram showing the position of the first monitoring element in the ablation catheter provided in other embodiments of this application; Figure 19 This is a schematic diagram showing the position of the first monitoring element in the ablation catheter provided in some embodiments of this application; Figure 20This is a partial structural schematic diagram of the ablation catheter provided in the embodiments of this application, which shows the structure and layout of the second monitoring element in some embodiments; Figure 21 This is a cross-sectional schematic diagram of the second monitoring element provided in the embodiments of this application; Figure 22 This is a partial structural diagram of a functional component provided in an embodiment of this application, showing the first mounting component and its surrounding structure; Figure 23 This is a schematic diagram of the structure of the first constraint ring provided in an embodiment of this application; Figure 24 This is a partial structural schematic diagram of the functional components provided in the embodiments of this application, showing an exploded view of the second mounting component and its surrounding structure; Figure 25 This is a schematic diagram of the structure of the retractor provided in the embodiments of this application; Figure 26 This is a schematic diagram of the structure of the cap provided in an embodiment of this application; Figure 27 This is a cross-sectional schematic diagram of the functional components provided in the embodiments of this application; Figure 28 yes Figure 27 A magnified view of part A in the middle; Figure 29 This is a cross-sectional schematic diagram of the retractor provided in the embodiments of this application; Figure 30 This is a schematic diagram showing the position of the first mounting component relative to the central axis of the functional component according to an embodiment of this application; Figure 31 This is a schematic diagram showing the position of the second mounting component relative to the central axis of the functional component according to an embodiment of this application; Figure 32 This is one of the flowcharts illustrating the ablation monitoring method provided in the embodiments of this application; Figure 33 This is a second schematic flowchart of the ablation monitoring method provided in the embodiments of this application; Figure 34 This is the third flowchart illustrating the ablation monitoring method provided in the embodiments of this application; Figure 35 This is the fourth flowchart of the ablation monitoring method provided in the embodiments of this application; Figure 36 This is the fifth flowchart of the ablation monitoring method provided in the embodiments of this application.

[0011] Explanation of reference numerals in the attached figures: 10. Conduit assembly; 11. Main tube; 12. Support bar; 13. Retractor; 131. Connector; 132. Retractor; 132a. Retractor hole; 132b. Locking groove; 14. Sealing ring; 20. Functional component; 21. Ablation component; 211. First mounting component; 2111. First restraint ring; 2112. Second restraint ring; 211a. Axis of the first mounting component; 212. First electrode; 2121. Proximal first electrode; 2122. Distal first electrode; 2123. Proximal first electrode; 2124. Distal first electrode; 2125. Intermediate first electrode; 212a. First connecting wire; 22. Monitoring component; 221. Second mounting component; 221a. Axis of the second mounting component; 2211. First insulating tube; 2212. Second insulating tube. 2213, tube; 2214, first metal wire; 2215, second metal wire; 222, first monitoring element; 2221, first measuring end; 2222, second measuring end; 2223, first metal element; 2224, second metal element; 223, second monitoring element; 2231, third measuring end; 2232, fourth measuring end; 2233, third insulating tube; 2233a, third window; 2234, fourth insulating tube; 2234a, fourth window; 2235, third metal wire; 2236, fourth metal wire; 224, third monitoring element; 23, cover; 231, locking protrusion; 20a, center meridian; 20b, central area; 20c, central axis of functional component; 20d, first virtual weft coil; 20e, virtual arc connection; 20f, virtual straight line connection. Detailed Implementation

[0012] It should be understood that the examples and illustrations in this application are for illustrative purposes, and deviations and variations can be constructed and deployed based on the teachings of this application without departing from the scope of this application. Before detailing at least one embodiment of this application, it should be understood that this application is not necessarily limited to the detailed configuration and arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or embodiments. This application can have other embodiments or can be practiced or implemented in different ways.

[0013] Unless otherwise defined, all technical and / or scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. While similar or equivalent methods and materials to those described in this application may be used to practice or test embodiments of this application, exemplary methods and / or materials are described below. In the event of any conflict, the specification (including definitions) of this application shall prevail. Furthermore, these materials, methods, and embodiments are illustrative only and are not intended to impose necessary limitations.

[0014] In the description of this application, unless otherwise expressly specified and limited, the terms "set at," "contained in," "alongside," "connected," "fixed," "fixed to," or "fixed connection," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two elements or the interaction between two elements. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances. Furthermore, the terms "first," "second," etc., are used merely for descriptive distinction and have no special meaning.

[0015] In this application, the distal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that are exemplarily far from the user during use (or, the distal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that exemplarily come into contact with or intervene in the tissue of the organism when used on a living organism), and the proximal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that are exemplarily close to the operator during operation (or, the proximal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that are exemplarily far from the tissue of the organism when used on a living organism compared to the distal end).

[0016] Atrial fibrillation and other arrhythmias can lead to stroke, cardiomyopathy, and in severe cases, death. Pulsed field ablation (PFA) is an interventional treatment for arrhythmias that relies on the irreversible electroporation (IRE) effect to ablate myocardial tissue. In PFA, electrodes release energy to generate an electric field, creating an electric field gradient in the tissue. For example, a gradient from the anode to the cathode is formed between paired anode and cathode electrodes. Both the anode and cathode can be placed in the target tissue, or one can be placed outside the body as a return electrode. When the cell membrane of the target tissue is exposed to this electric field, the energy of the electric field can be used to completely or locally ablate the target tissue.

[0017] An ablation system used for tissue ablation typically includes an ablation catheter, a handle, and a control and display device.

[0018] An ablation catheter generally includes a catheter assembly, a petal-shaped structure connected to the distal end of the catheter assembly, and an electrode array arranged on the petal-shaped structure. The electrode array can apply ablation energy to the target area. The distal portion of the ablation catheter can reach the vicinity of the tissue to be ablated, for example, it can reach the vicinity of the cardiac tissue to be ablated along a blood vessel. The ablation catheter can reach the target location under the guidance of a guide sheath or guidewire. The embodiments of this application do not particularly limit the guidance method of the ablation catheter.

[0019] The target area can include living tissue, ex vivo tissue, and models.

[0020] In some implementations, a handle is typically attached to the proximal end of the ablation catheter for the user to grip and operate. The handle controls the ablation catheter, at least controlling the advancement, retraction, rotation, deflection of the catheter components within the ablation catheter, as well as the unfolding / contraction of the petal-shaped structure. The handle may also integrate electrical control switches or buttons for operations such as outputting and stopping ablation energy, and switching modes.

[0021] The control and display device can be electrically and / or communicatively connected to the handle and ablation catheter. The control and display device may include a controller, a display, etc. The controller may include a memory and a processor, and can at least issue control commands, process and judge data from the ablation catheter. The display can at least show the user information related to the working status of the ablation catheter, such as the ablation location, ablation parameters, and whether the ablation energy has reached the preset energy target; the display may also be a touchscreen display, which can not only display relevant information but also allow the user to input data.

[0022] Electrode arrays used to generate ablation energy can include paired electrodes. Typically, the electric field and current density are strongest near the electrode surface, while the electric field strength gradually decreases as the distance between the paired electrodes increases. This results in a weaker electric field and lower current density in the central region between the paired electrodes, exhibiting an uneven electric field distribution. Therefore, in current practical applications, the ablation zone between the paired electrodes may be too small or even empty, making it difficult for the electric field to completely cover the target lesion, potentially leading to incomplete ablation of the target area.

[0023] To address this situation, it is desirable to provide a technique for providing electric field strength feedback or monitoring in areas with weak electric field strength between paired electrodes (such as the central region between paired electrodes when both electrodes are located in the target area). Furthermore, it is desirable to provide electric field strength control based on the monitoring results so that the regions between paired electrodes, including the central region of the paired electrodes, have sufficient electric field ablation energy, thereby facilitating thorough ablation of the target area. Of course, the technique of this application can also provide corresponding feedback or monitoring for situations where excessive electric field energy may lead to over-ablation (such as damage to non-target areas caused by expanding the ablation area or deepening the ablation depth).

[0024] Below, in conjunction with Figures 1 to 31 The ablation catheter provided in the embodiments of this application will be described.

[0025] like Figure 1 As shown, some embodiments of this application provide an ablation catheter, which is generally elongated and extends longitudinally, including a proximal end and a distal end. Hereinafter, the direction from the distal end to the proximal end is referred to as direction a, and the direction from the proximal end to the distal end is referred to as direction b.

[0026] In some embodiments, such as Figure 2 and Figure 3 As shown, the ablation catheter includes a catheter assembly 10 and a functional component 20. The catheter assembly 10 includes a main tube 11 and a support strip 12, the support strip 12 passing through the main tube 11 (coaxially arranged) and the two being axially movable relative to each other. The distal end of the functional component 20 is connected to the support strip 12, and the proximal end of the functional component 20 is connected to the main tube 11. The proximal and distal ends of the functional component 20 can move closer or further apart as the support strip 12 and the main tube 11 move relative to each other axially, and the functional component 20 can accordingly adopt an expanded or contracted shape in the radial direction.

[0027] In some embodiments, Figure 1 The shape shown is a contraction shape. Figure 2 The shape shown is the fully expanded form (which can be called a petal shape). Figure 3 The shape shown is a moderately expanded unfolded shape; in other embodiments, Figure 1 The shape shown is a contraction shape. Figure 3 The shape shown is the expanded form at its maximum extent (which can be called a cage shape).

[0028] The functional component 20 includes an ablation component 21 and a monitoring component 22. The ablation component 21 includes at least two first mounting members 211, each of which has at least one first electrode 212 for releasing ablation energy. Two circumferentially adjacent first mounting members 211 form a pairing support group. The first electrode 212 on one of the first mounting members 211 in the pairing support group has a first polarity, and the first electrode 212 on the other first mounting member 211 has a second polarity. A first electrode 212 with the first polarity and a first electrode 212 with the second polarity on the pairing support group form a pairing electrode group. At least one pairing electrode group is provided on the pairing support group. Exemplarily, the first mounting member 211 can be a strip-shaped structure.

[0029] The monitoring component 22 includes at least one second mounting member 221, on which at least one first monitoring member 222 is disposed. The first monitoring member 222 is used to monitor the voltage signal of its location to determine the electric field strength of the location. This location is a local area within the target area of ​​the ablation energy (such as the cell membrane of an ex vivo tissue, living tissue, or simulated tissue). At least one second mounting member 221 is arranged between two first mounting members 211 in at least one paired support group, and the first mounting members 211 and the second mounting members 221 are distributed at circumferential intervals along the functional component 20. A first monitoring member 222 on the second mounting member 221 is correspondingly disposed between at least one paired electrode group on the paired support group to which it is located. Exemplarily, the second mounting member 221 can be a strip structure.

[0030] Therefore, by monitoring local areas to determine the intensity of ablation energy in the target area, especially by selecting a location with relatively low ablation energy in the target area as the local area monitored by the first monitoring element 222, it is possible to reliably determine whether the ablation energy intensity in the target area has reached the preset target intensity based on the monitoring results, thereby providing a reliable basis for adjusting the intensity of ablation energy.

[0031] The catheter assembly 10 may be generally tubular. The direction of extension of the catheter assembly 10 may be considered longitudinal.

[0032] The catheter assembly 10 includes a main tube 11 and a support strip 12. Exemplarily, the main tube 11 may be a longitudinally extending hollow tube, and the support strip 12 may be a longitudinally extending rod. The support strip 12 may be solid or hollow. In some embodiments, the support strip 12 is constructed as a longitudinally extending hollow tube, the hollow cavity of which can be used to pass a guidewire, which can guide the catheter assembly 10 forward and backward in direction a or direction b. The radial dimension of the main tube 11 is larger than the radial dimension of the support strip 12. The main tube 11 is fitted around the periphery of the support strip 12, and the axis of the main tube 11 and the axis of the support strip 12 may be coaxial or eccentric.

[0033] In some embodiments, the longitudinal length of the support bar 12 may be greater than the longitudinal length of the main tube 11, at least allowing the distal end of the support bar 12 to protrude from the distal end of the main tube 11. The support bar 12 may move within the main tube 11 in direction a or direction b, or rotate relative to the main tube 11. Of course, in other embodiments, the main tube 11 may also move relative to the support bar 12 in direction a or direction b, or rotate relative to the main tube 11.

[0034] Functional component 20 can at least perform deformation, provide ablation energy, and monitor the energy field. Functional component 20 is connected to conduit assembly 10.

[0035] At least a portion of the functional component 20 may undergo flexural deformation. In some embodiments, the distal end of the functional component 20 is connected to the support bar 12, and the proximal end of the functional component 20 is connected to the main tube 11. As the main tube 11 moves relative to the support bar 12, the distal and proximal ends of the functional component 20 move closer or further apart, causing the functional component 20 to undergo flexural deformation.

[0036] As the distal and proximal ends of functional component 20 approach each other, the middle section of functional component 20 moves away from the catheter assembly 10 or the central axis 20c of the functional component, causing the middle section of functional component 20 to gradually bulge outward radially, i.e., to exhibit an expanded shape radially. As the distal and proximal ends of functional component 20 move away from each other, the middle section of functional component 20 moves towards the catheter assembly 10 or the central axis 20c of the functional component, causing the middle section of functional component 20 to gradually contract inward radially, i.e., to exhibit a contracted shape radially.

[0037] In some specific embodiments, the functional component 20 may include a petal-shaped structure (petal-shaped support), in which the functional component 20 is petal-shaped when it is in an extended state.

[0038] Here, "radial" refers to the radial direction of the catheter assembly 10 or the radial direction of the functional component 20. The axial direction, extension direction, and longitudinal direction of the catheter assembly 10 all refer to the same direction. The central axis of the catheter assembly 10 is parallel to its axial direction. The radial direction of the catheter assembly 10 is perpendicular to its axial direction. The axial direction of the functional component 20 coincides with the axial direction of the catheter assembly 10, and the radial direction of the functional component 20 coincides with the radial direction of the catheter assembly 10. In some embodiments, the catheter assembly 10 includes a flexible shaft segment to change the orientation of the distal end of the catheter assembly 10. In such embodiments, unless otherwise specified, "axial" and "radial" refer to the axial and radial directions of the catheter assembly within the shaft segment containing the functional component 20.

[0039] Functional component 20 includes ablation component 21, which is used to provide ablation energy to the target area.

[0040] The ablation component 21 includes a first mounting member 211 and a first electrode 212 disposed on the first mounting member 211. The first mounting member 211 is disposed on the periphery of the catheter assembly 10 and is flexible. In some embodiments, the proximal end of the first mounting member 211 is connected to the main tube 11, and the distal end of the first mounting member 211 is connected to the support bar 12. As the main tube 11 and the support bar 12 move closer or further apart, the middle section of the first mounting member 211 flexes to bring the proximal and distal ends of the first mounting member 211 closer or further apart. That is, by bringing the proximal and distal ends of the first mounting member 211 closer or further apart, the first mounting member 211 can be flexed, bent, or stretched, and the middle section of the first mounting member 211 moves away from or closer to the catheter assembly 10, causing the first mounting member 211 to expand or contract radially. By expanding or contracting the first mounting member 211, the position of the first electrode 212 carried on the first mounting member 211 can be adjusted so that the first electrode 212 can be aligned with the target position and close to or even against the target position.

[0041] In some embodiments, when the proximal and distal ends of the first mounting member 211 are brought into maximum proximity, the first mounting member 211 and the functional component 20 can be in a maximum extended state. The first mounting member 211 in the maximum extended state can be in the shape of a petal, and the functional component 20 in the maximum extended state can be in the shape of a flower including multiple petals.

[0042] The embodiments of this application do not impose any particular limitation on the cross-sectional shape of the first mounting member 211. Exemplarily, the cross-section of the first mounting member 211 can be circular, elliptical, oblong, rectangular, irregular, etc.

[0043] The number of first mounting members 211 is at least two, for example, two, three, five, six, etc. In some embodiments, the first mounting members 211 may be evenly distributed around the central axis 20c of the functional component. Unless otherwise specified, the direction around the central axis 20c of the functional component may be referred to as the circumferential direction of the functional component. Two circumferentially adjacent first mounting members 211 are considered as a pairing support group; in other words, the ablation member 21 includes at least one pairing support group, and a pairing support group includes two circumferentially adjacent first mounting members 211.

[0044] For example, the ablation component 21 includes four first mounting members 211 arranged sequentially and adjacently along the circumference. For ease of explanation, they are referred to as first mounting member 211-A, first mounting member 211-B, first mounting member 211-C, and first mounting member 211-D, respectively. Optionally, first mounting member 211-A and first mounting member 211-B, first mounting member 211-B and first mounting member 211-C, first mounting member 211-C and first mounting member 211-D, and first mounting member 211-D and first mounting member 211-A can be respectively used as paired support groups; or, first mounting member 211-A and first mounting member 211-B, first mounting member 211-C and first mounting member 211-D can be respectively used as paired support groups.

[0045] The first electrode 212 disposed on the first mounting member 211 can release ablation energy. Exemplarily, an ablation electric field can be provided.

[0046] The first electrode 212 may have a first polarity or a second polarity. That is, the first electrode can switch between the first polarity and the second polarity.

[0047] In some embodiments, a pairing support group includes at least one pairing electrode group, which includes two first electrodes 212 with opposite polarities (or different first and second polarities). One first electrode 212 is located on a first mounting member 211 in the pairing support group, and the other first electrode 212 is located on another first mounting member 211 in the pairing support group. Exemplarily, one first electrode 212 in the pairing electrode group has a positive polarity (or anode polarity), and the other first electrode 212 has a negative polarity (or cathode polarity). The first electrode 212 can be made to have a positive or negative polarity, and the electrodes in the pairing support group can be made into a pairing electrode group, controlled by a handle or controller. The pairing electrode group can generate an energy field; exemplarily, it can generate an electric field, the intensity of which is characterized by a voltage signal. In other words, voltage is the source of the electric field, and measuring or setting the voltage of the pairing electrode group can indirectly reflect the electric field characteristics of the target area where the ablation energy is applied.

[0048] In some other embodiments, a pairing support group includes at least one pairing electrode group, which includes two first electrodes 212 with the same polarity (or the first polarity and the second polarity are the same). One of the first electrodes 212 is located on a first mounting member 211 in the pairing support group, and the other first electrode 212 is located on another first mounting member 211 in the pairing support group. However, a return electrode with a different polarity is disposed in other locations, such as outside the body or in the catheter assembly 10. This return electrode cooperates with the pairing electrode group to form an ablation electric field.

[0049] In other embodiments, a pairing support group includes at least one pairing electrode group, which includes two first electrodes 212 with the same polarity (or the first polarity and the second polarity are the same). One first electrode 212 is located on a first mounting member 211 in the pairing support group, and the other first electrode 212 is located on another first mounting member 211 in the pairing support group. The first electrodes 212 with the same polarity can be further paired with another pairing electrode group with a different polarity. For example, a pairing support group includes two pairs of pairing electrode groups, one pair of pairing electrode groups being positively polarized and the other pair of pairing electrode groups being negatively polarized. These two pairs of pairing electrode groups cooperate to form an ablation electric field. One or more first electrodes 212 can be provided on the first mounting member 211. When two or more first electrodes 212 are provided on a single first mounting member 211, the first electrodes 212 are spaced apart from each other along the extension direction of the first mounting member 211 (parallel to the direction of the axis 211a of the first mounting member). The polarities of the multiple first electrodes 212 located on the same first mounting member 211 can be the same or different, as long as they can form a paired electrode group with the first electrode 212 on another first mounting member 211 belonging to the same paired support group.

[0050] In some embodiments, the polarity of the first electrode 212 can be switched between a first polarity and a second polarity, for example, by control of a handle or controller. For the same first electrode 212, the electrode polarity before and after the switch can be the same or different, as long as a paired electrode group can be formed within the same paired support group. Additionally, the first electrode 212 can also be switched to a de-energized state. Specific first electrodes 212 can be selected according to the ablation location to form a paired electrode group.

[0051] Functional component 20 also includes a monitoring component 22, which is used to monitor voltage signals to determine electric field strength.

[0052] like Figure 3As shown, the monitoring component 22 includes a second mounting member 221 and a first monitoring member 222 disposed on the second mounting member 221. The second mounting member 221 is disposed on the periphery of the conduit assembly 10 and is flexible. In some embodiments, the proximal end of the second mounting member 221 is connected to the main tube 11, and the distal end of the second mounting member 221 is connected to the support bar 12. As the main tube 11 and the support bar 12 move closer or further apart, the middle section of the second mounting member 221 flexes to bring the proximal and distal ends of the second mounting member 221 closer or further apart. That is, by bringing the proximal and distal ends of the second mounting member 221 closer or further apart, the second mounting member 221 can be flexed, bent, or stretched, and the middle section of the second mounting member 221 moves away from or closer to the conduit assembly 10, causing the second mounting member 221 to expand or contract radially. By expanding or contracting the second mounting member 221, the position of the first monitoring member 222 carried on the second mounting member 221 can be adjusted so that the first monitoring member 222 changes in accordance with the position change of the first electrode 212 on the first mounting member 211.

[0053] In some embodiments, when the proximal and distal ends of the second mounting member 221 are maximally close together, the second mounting member 221 can be in a maximally extended state, and the second mounting member 221 in the maximally extended state can be in the shape of a petal. In some embodiments, when the proximal and distal ends of the second mounting member 221 are maximally close together, the proximal and distal ends of the first mounting member 211 are also in a maximally close together state; in other words, the functional component 20 is in a maximally extended state, and the functional component 20 in the maximally extended state can be in the shape of a flower including multiple petals.

[0054] The embodiments of this application do not impose any particular limitation on the cross-sectional shape of the second mounting member 221. Exemplarily, the cross-section of the second mounting member 221 can be circular, elliptical, oblong, rectangular, irregular, etc.

[0055] The number of second mounting members 221 is at least one, such as one, two, four, etc. In some embodiments, the second mounting members 221 may be evenly distributed around the central axis 20c of the functional component.

[0056] In at least one paired support group, a second mounting member 221 is arranged between two first mounting members 211, the second mounting member 221 being circumferentially spaced from the first mounting members 211 located on either side thereof. The size of the interval can be determined based on the interval between two first mounting members 211 in the same paired support group. In some embodiments, the second mounting member 221 is equally spaced from the first mounting members 211 located on either side thereof.

[0057] During the relative movement of the main tube 11 and the support strip 12, both the first mounting member 211 and the second mounting member 221 undergo flexural deformation, causing the first mounting member 211 and the second mounting member 221 to be in an expanded state or a contracted state together. In some embodiments, when the proximal and distal ends of the first mounting member 211 and the second mounting member 221 are brought to their maximum proximity, the functional component 20 is in a maximum expanded state. The functional component 20 in the maximum expanded state can be in the shape of a flower including multiple petals, and along the circumferential direction, the petals formed by the flexing of the second mounting member 221 are located between the petals formed by the flexing of the two first mounting members 211.

[0058] The first monitoring element 222, which is mounted on the second mounting component 221, can monitor the voltage signal of its own area.

[0059] In some embodiments, at least one first monitoring element 222 is provided on each of the second mounting members 221. When two or more first monitoring elements 222 are provided on the second mounting member 221, the first monitoring elements 222 can be arranged at intervals along the extension direction of the second mounting member 221 (a direction parallel to the axis 221a of the second mounting member).

[0060] In some embodiments, the first monitoring element 222 monitors the voltage signal of the surrounding environment of the target area to provide feedback on whether the first monitoring element 222 is sufficiently in contact with the target area. For example, if the voltage signal is too low, such as only 30% of the preset threshold, it can indicate that the first monitoring element 222 is not sufficiently in contact with the target area, and can also indirectly indicate that the functional component 2 is not sufficiently in contact with the target area. The first monitoring element 222 is arranged in the area between the two first mounting members 211 in its paired support group, and is located between the paired electrode groups.

[0061] The area between the two first mounting members 211 is located between the paired electrode groups. This can be understood as the circumferential arc surface of the two first mounting members 211 being located between the paired electrode groups of the two first mounting members 211, or it can be understood as a position that is closer to the inner side and protrudes outward in the radial direction than the arc surface mentioned above.

[0062] Since the functional component 20 can be radially extended or contracted, when the functional component 20 is in the contracted form, the ablation catheter occupies less space, making it suitable for narrow spaces and facilitating smooth entry and exit of the ablation catheter in confined spaces. When the functional component 20 is in the extended form, it expands radially, helping it to approach the target area. Because the paired support group contains a paired electrode group, an ablation energy field (e.g., an electric field) can be generated between the two first electrodes 212 in the paired electrode group, thereby enabling ablation of the target area using the ablation energy field. Since a second mounting member 221 is arranged between the two first mounting members 211 in at least one paired support group, and the second mounting member 221 is equipped with at least one first monitoring member 222, and the first monitoring member 222 is positioned corresponding to the paired electrode group, the first monitoring member 222 is located within the ablation energy field and can monitor the voltage signal at its location. This allows for determination of the range or intensity of the ablation energy field based on the voltage signal, and assessment of whether a preset range or intensity has been reached. Based on the results of this determination and judgment, the user can adjust the functional components so that the target location can receive radiation from an energy field of preset range or preset intensity, thereby facilitating full and thorough ablation.

[0063] Furthermore, by placing the first monitoring element 222 between the paired electrode groups, locations with relatively low energy in the energy field (e.g., electric field) formed by the distribution electrode groups can be monitored to reflect the intensity of the energy field in their respective areas. Specifically, if the energy field intensity (e.g., electric field intensity) at a relatively low energy location has reached a preset target intensity, the energy field intensity at other locations (e.g., the location of the first electrode 212) is also likely to have reached the preset target intensity. Therefore, the target area can be fully and thoroughly ablated.

[0064] Below, in conjunction with Figures 4 to 25 The positional relationship between the first mounting component 211 and the paired electrode group and the second mounting component 221 and the first monitoring component 222 will be further explained.

[0065] In some embodiments, such as Figure 4As shown, along the circumference of the functional component 20, the virtual line connecting the center points of the two first mounting members 211 in the paired support group constitutes the central meridian 20a, which extends along the length of the functional component 20. Along the circumference of the functional component 20, the paired support group has a central region 20b, which is formed by the central meridian 20a extending equidistantly from the first mounting members 211 on both sides. The circumferential length of the central region 20b is 1-20% of the maximum circumferential length between the two first mounting members 211 in the paired support group. The central region 20b is located between the paired electrode groups in the corresponding paired support group, and at least one first monitoring member 222 on at least one second mounting member 221 in the paired support group is located in the central region 20b of the corresponding paired support group.

[0066] To facilitate the explanation of the positional relationships among the components of functional component 20, meridians and parallels are introduced. The extended functional component 20 is considered a sphere or ellipsoid (or rugby ball), and its surface is regarded as a reference sphere. Similar to the meridians and parallels of the Earth, a meridian is the shortest line segment connecting the far and near ends on this reference sphere, and a parallel is a loop on this reference sphere that intersects the meridians perpendicularly. It should be noted that meridians and parallels are virtual lines, not physical structures possessed by functional component 20.

[0067] The virtual line connecting the center points of the two first mounting members 211 in the paired support group constitutes the central meridian 20a. This means that the central meridian 20a is located between the two first mounting members 211 in the paired support group, and any position on the central meridian 20a is located in the middle of the two first mounting members 211 (belonging to the same paired support group) on both sides of the meridian.

[0068] Along the circumferential direction of the functional component 20, a central region 20b is provided between the two first mounting members 211 in the same paired support group, and a central meridian 20a is located at the circumferential center of the central region 20b. In some embodiments, the central region 20b is a space for arranging a second mounting member 221 between the two first mounting members 211 in the same paired support group.

[0069] In some embodiments, the circumferential length of the central region 20b is 1% to 20% of the maximum circumferential length between the two first mounting members 211 in the paired support group. The maximum circumferential length between the two first mounting members 211 refers to the circumferential length between the two first mounting members 211 on the weft loop with the largest diameter on the reference sphere.

[0070] For example, the circumferential length of the central region 20b can be 1%, 5%, 8%, 12%, 15%, 20%, or any two of the maximum circumferential lengths between the two first mounting members 211 in its mating support group. Of course, values ​​prior to the above can also be used.

[0071] Since the circumferential length of the central region 20b is 1% to 20% of the maximum circumferential length between the two first mounting members 211 in its paired support group, the area for arranging the second mounting member 221 is located in the central region of the area between the two first mounting members 211 in its paired support group. Considering that the electric field strength is lower the further away from the first electrode 212 in the ablation electric field, arranging the second mounting member 221 in a region with a relatively low electric field length facilitates the first monitoring element 222 on the second mounting member 221 to monitor the electric field strength in this low electric field strength region, so as to determine that the electric field strength in this region has reached the predetermined target strength.

[0072] like Figure 4 As shown, the first monitoring element 222 on the second mounting element 221 between the two first mounting elements 211 in the paired support group is located in the central region 20b of the corresponding paired support group, and the central region 20b is located between the first electrodes 212 of the paired electrode group in the corresponding paired support group.

[0073] Along the circumference of the functional component 20, the central region 20b is located between the two first mounting members 211 in the mating support group; along the extension direction of the central meridian 20a, the central region 20b is located between the two first electrodes 212 of the mating electrode group in the mating support group. That is, the two first electrodes 212 of the mating electrode group in the mating support group can form an electric field region that covers a certain spatial range in both the circumference of the functional component 20 and the extension direction of the central meridian 20a. The central region 20b for arranging the first monitoring member 222 (or, the area in the central region 20b for arranging the first monitoring member 222) is located within this spatial range, exemplarily, at the center of this spatial range.

[0074] Therefore, the voltage signal of the central region 20b between the two first electrodes 212 in the paired electrode group can be monitored by the first monitoring element 222, so that the first monitoring element 222 can monitor the voltage signal at the lower energy distribution in the ablation electric field. If the energy at the lower energy position can meet the ablation requirement, it means that the energy at other positions can also meet the ablation requirement.

[0075] In some embodiments, such as Figure 5As shown, the monitoring component 22 includes at least two second mounting members 221; at least two first mounting members 211 and at least two second mounting members 221 are alternately distributed along the circumference of the functional component 20, such that a second mounting member 221 is provided between two circumferentially adjacent first mounting members 211 of the functional component 20.

[0076] In some specific embodiments, such as Figure 5 As shown, the second mounting member 221 between two first mounting members 211 in the paired support group is located in the central region 20b of its corresponding paired support group. That is, the number of first mounting members 211 can be equal to the number of second mounting members 221. The central region 20b between two first mounting members 211 in the paired support group is provided with a second mounting member 221. The same number of first mounting members 211 and second mounting members 221 are alternately distributed along the circumference of the functional component 20, so that a second mounting member 221 is provided between every two adjacent first mounting members 211 along the circumference of the functional component 20.

[0077] In other specific embodiments, such as Figure 7 As shown, the second mounting member 221 between two circumferentially adjacent first mounting members 211 of the functional component 20 is either radially outward or radially inward compared to the central region 20b.

[0078] Thus, the first mounting component 211 and the second mounting component 221 are evenly distributed. On the one hand, this is conducive to maintaining the symmetrical expansion and contraction of the overall shape of the functional component 20. On the other hand, any two adjacent first mounting components 211 in the circumferential direction can serve as a pairing support group, and the areas between them all have second mounting components 221 that support the first monitoring component 222, which can realize the monitoring of the energy field intensity. Therefore, it is conducive to achieving full and thorough ablation with sufficient energy intensity.

[0079] In some embodiments, such as Figure 6 As shown, a second mounting member 221 is provided in the central region 20b between the two first mounting members 211 in the paired support group; and, along the circumferential projection of the functional component 20, the two first electrodes 212 in the paired electrode group at least partially overlap.

[0080] The fact that the two first electrodes 212 in the paired electrode group at least partially overlap when projected circumferentially along the functional component 20 means that the two first electrodes 212 in the paired electrode group can be on the same weft coil (partially overlapping with the weft coil).

[0081] Therefore, the distance between the two first electrodes 212 located on the same weft coil is small, which makes it easier to form a uniform ablation electric field.

[0082] As described above, when the functional component 20 is in an unfolded form, the functional component 20 can define a reference sphere, which in some embodiments may be spherical or rugby ball-shaped.

[0083] For example, when the functional component 20 is in an unfolded form, the shape of the reference spherical surface defined by the functional component 20 on the cross-section perpendicular to the central axis 20c of the functional component can be a regular shape or an irregular shape. Regular shapes include circles, convex circular arc polygons, and concave circular arc polygons. The circumferential direction of the functional component 20 can be understood as the direction of movement along the edge of the cross-section of the functional component 20 (perpendicular to the axis of the functional component 20).

[0084] In some embodiments, such as Figure 7 As shown, when the functional component 20 is in its unfolded form, the functional component 20 defines a reference sphere on which at least one first monitoring element 222 on at least one second mounting member 221 in at least one paired support group is located.

[0085] Optionally, the first monitoring element 222 on the second mounting element 221 between two first mounting elements 211 in a pair of support groups may be located on a reference spherical surface; or, the first monitoring element 222 on the second mounting element 221 between two first mounting elements 211 in all pair of support groups may be located on a reference spherical surface.

[0086] In other embodiments, such as Figure 7 As shown, for at least one second mounting member 221 between two first mounting members 211 in at least one paired support group, at least one first monitoring member 222 on the second mounting member 221 protrudes from the reference spherical surface, or is recessed into the reference spherical surface.

[0087] Therefore, by placing the first monitoring element 222 on or protruding from the reference spherical surface, the first monitoring element 222 is not only located within the ablation electric field but also easily accessible to or even in contact with the target area. This allows for the monitoring of the intensity of the ablation electric field acting on the target area, contributing to accurate monitoring results. By recessing the first monitoring element 222 into the reference spherical surface, the first monitoring element is protected within the internal space enclosed by the first mounting element 211 and the second mounting element 221, reducing pressure from surrounding tissues on the second mounting element 221 and the first monitoring element 222, or in other words, reducing pressure from the second mounting element 221 and the first monitoring element 222 on surrounding tissues.

[0088] In some embodiments, such as Figure 6As shown, the first monitoring component 222 includes a first measuring end 2221 and a second measuring end 2222, both of which are fixed to the second mounting component 221. The first measuring end 2221 is used to collect a first voltage signal in its area, and the second measuring end 2222 is used to collect a second voltage signal in its area. The first voltage signal and the second voltage signal are used to calculate the difference between them to obtain a voltage signal.

[0089] Furthermore, the electric field strength value can be calculated based on the voltage signal and the distance between the first measuring terminal 2221 and the second measuring terminal 2222. This allows for the indirect monitoring of the ablation electric field value.

[0090] In some embodiments, such as Figure 8 As shown, the second mounting component 221 includes a first insulating tube 2211 and a second insulating tube 2212; the second mounting component 221 also includes a first metal wire 2213 and a second metal wire 2214, the first metal wire 2213 passing through the first insulating tube 2211 and the second metal wire 2214 passing through the second insulating tube; the first insulating tube 2211 has a first window to expose a portion of the first metal wire 2213 as a first measuring end 2221; the second insulating tube 2212 has a second window to expose a portion of the second metal wire 2214 as a second measuring end 2222.

[0091] The first metal wire 2213 and the second metal wire 2214 may be made of the same or different materials. For example, the first metal wire 2213 and the second metal wire 2214 may be made of stainless steel or nickel-titanium alloy.

[0092] Because the metal wires are threaded through the insulating tube, the tube guides and protects them, reducing the risk of accidental conduction. Since the metal wires are partially exposed through windows in the insulating tube, with the exposed portion serving as the measuring end, the structure is relatively simple; the measuring end does not occupy additional space and is easy to manufacture. Furthermore, the fact that all the metal wires are housed within the insulating sleeve facilitates the fixing of the first metal wire 2213 and the second metal wire 2214, ensuring a defined circumferential distance between them and improving the accuracy of the electric field strength calculation.

[0093] In some embodiments, such as Figure 6 As shown, a first metal component 2223 is fixed at the exposed position of the first metal wire 2213 in the first insulating tube 2211 as a first measuring end 2221; a second metal component 2224 is fixed at the exposed position of the second metal wire 2214 in the second insulating tube 2212 as a second measuring end 2222. The first metal component 2223 and the second metal component 2224 may be made of the same or different materials.

[0094] For example, the first metal part 2223 and the second metal part 2224 may be made of stainless steel or nickel-titanium alloy.

[0095] Therefore, voltage signals can be obtained using the attached first metal part 2223 and second metal part 2224, which improves the design freedom of the measurement method.

[0096] The positional relationship between the first monitoring element 222 and the first electrode 212 in the paired electrode group will be explained below.

[0097] In some embodiments, along the circumferential projection of the functional component 20, a first monitoring element 222 on the second mounting member 221 at least partially overlaps with at least one first electrode 212 on its corresponding paired electrode group.

[0098] In some embodiments, such as Figure 9 As shown, for at least one second mounting member 221 between two first mounting members 211 in at least one paired support group, at least one first monitoring member 222 on the second mounting member 221 is located on a reference spherical surface. An embodiment of this structure is described.

[0099] like Figure 6 and Figure 9 As shown, along the circumference of the functional component 20, at least one first electrode 212 of each of the two first mounting members 211 in at least one paired support group is located on the same virtual weft coil as the first virtual weft coil 20d. Two adjacent first electrodes 212 located on the same virtual weft coil are considered as a paired electrode group. The arc segment between the two first electrodes 212 in the paired electrode group on the first virtual weft coil 20d is the first connecting line 212a. The first connecting line 212a is located in a plane perpendicular to the extension direction of the conduit assembly 10. At least one first monitoring member 222 on the second mounting member 221 that intersects with the first connecting line 212a at least partially coincides with the first connecting line 212a and is located in the central region 20b.

[0100] Each second mounting component 221 has at least one first monitoring component 222 that overlaps with the first virtual weft coil 20d; and the second mounting component 221 is located in the central region 20b.

[0101] This allows the paired electrode group and the first monitoring element 222 between them to be located on the same virtual dotted coil, which is beneficial for monitoring the voltage signal at the target area where the ablation electric field acts, and helps to obtain accurate monitoring results.

[0102] The first monitoring element 222 can be an electric field sensor. A second mounting element 221 is disposed between the two first mounting elements 211 in the paired support group, and the electric field sensor is disposed on the second mounting element 221. When both first electrodes 212 of the paired electrode group in the paired support group are located at the first virtual weft coil 20d, the electric field sensor can at least partially coincide with the first virtual weft coil 20d.

[0103] In some embodiments, such as Figures 9 to 17 As shown, the first monitoring device 222 includes a first measuring end 2221 and a second measuring end 2222.

[0104] In some embodiments, a first monitoring element 222 on the second mounting member 221 is provided with at least one pairing electrode group on the pairing support group to which it is located. When projected along the circumferential direction of the functional component 20, the first measuring end 2221 and the second measuring end 2222 on the first monitoring element 222 both at least partially overlap with at least one first electrode 212 on the corresponding pairing electrode group.

[0105] The number of paired electrode groups on the paired support group can be one or more. Optionally, the first monitoring element 222 can correspond to one of the paired electrode groups, and the first measuring end 2221 and the second measuring end 2222 on the first monitoring element 222 can both at least partially overlap with one or both first electrodes 212 in that paired electrode group. Optionally, the first monitoring element 222 can correspond to two of the paired electrode groups, and the first measuring end 2221 of the first monitoring element 222 at least partially overlaps with one or both first electrodes 212 in one of the paired electrode groups, and the second measuring end 2222 at least partially overlaps with one or both first electrodes 212 in the other paired electrode group.

[0106] In some embodiments, such as Figure 10 As shown, the first monitoring element 222 corresponds to a pairing electrode group on its pairing support group. When projected along the circumferential direction of the functional component 20, the first measuring end 2221 and the second measuring end 2222 on the first monitoring element both at least partially overlap with the two first electrodes 212 on their corresponding pairing electrode groups.

[0107] like Figure 10 As shown, the first measuring end 2221 and the second measuring end 2222 can be located on the same virtual weft coil. When both first electrodes 212 of the paired electrode group in the paired support group are located on the first virtual weft coil 20d, the virtual weft coil where the first measuring end 2221 and the second measuring end 2222 are located can be the first virtual weft coil 20d, that is, the first measuring end 2221 and the second measuring end 2222 can both at least partially overlap with the first virtual weft coil 20d.

[0108] It should be noted that, Figure 10 Only one pairing electrode group on the paired support group is shown in the image, however, Figure 10 Other paired electrode groups can be arranged on the paired support group shown, and other first monitoring elements 222 can also be arranged to correspond with other paired electrode groups.

[0109] In some embodiments, such as Figures 11 to 17 As shown, each pairing support group has two, three or more pairing electrode groups.

[0110] In some embodiments, a first monitoring element 222 on the second mounting member 221 is correspondingly provided with two paired electrode groups on the paired support group to which it is located. When projected circumferentially along the functional component 20, the first measuring end 2221 on the first monitoring element 222 and at least one first electrode 212 on one of the paired electrode groups at least partially overlap, and the second measuring end 2222 on the first monitoring element 222 and at least one first electrode 212 on the other paired electrode group at least partially overlap.

[0111] like Figures 11 to 17 As shown, the first measuring end 2221 and the second measuring end 2222 can be staggered along the extension direction of the second mounting member 221. At least two mating electrode groups can be provided in the mating support group. For two adjacent mating electrode groups, along the circumferential projection of the functional component 20, the first measuring end 2221 may coincide with at least one first electrode 212 in one of the mating electrode groups, and the second measuring end 2222 may coincide with at least one first electrode 212 in the other mating electrode group.

[0112] exist Figure 11 In the specific embodiment shown, the first monitoring element 222 corresponds to two paired electrode groups. When projected along the circumferential direction of the functional component 20, the first measuring end 2221 on the first monitoring element 222 and the two first electrodes 212 on one of the paired electrode groups at least partially overlap, and the second measuring end 2222 on the first monitoring element 222 and the two first electrodes 212 on the other paired electrode group at least partially overlap.

[0113] In other words, such as Figure 11 As shown, a second mounting member 221 is disposed between two first mounting members 211 in the paired support assembly. A first measuring end 2221 and a second measuring end 2222 are respectively disposed on the second mounting member 221, and the first measuring end 2221 and the second measuring end 2222 are located on different virtual weft coils. The electric field strength value can be calculated using the voltage signal and distance between the first measuring end 2221 and the second measuring end 2222 along the offset direction.

[0114] exist Figure 12In the specific embodiment shown, the first monitoring element 222 corresponds to two paired electrode groups. When projected along the circumferential direction of the functional component 20, the first measuring end 2221 on the first monitoring element 222 and the two first electrodes 212 on one of the paired electrode groups at least partially overlap, and the second measuring end 2222 on the first monitoring element 222 and the first electrode 212 on the other paired electrode group at least partially overlap.

[0115] exist Figure 13 In the specific embodiment shown, the first monitoring element 222 corresponds to two paired electrode groups. When projected along the circumferential direction of the functional component 20, the first measuring end 2221 on the first monitoring element 222 and a first electrode 212 on one of the paired electrode groups at least partially overlap, and the second measuring end 2222 on the first monitoring element 222 and a first electrode 212 on the other paired electrode group at least partially overlap.

[0116] It is understandable that, with 2n (n being a natural number greater than 1) paired support groups in each paired support group, each pair of paired support groups can use... Figures 11 to 13 One or a combination of the arrangements of the first monitoring element 222 shown.

[0117] Figures 14 to 17 In the illustrated embodiment, each paired support group has three paired electrode groups, and the first monitoring element 222 corresponds to two of the paired electrode groups. Figures 14 to 16 As shown, each first mounting member 211 is provided with three first electrodes 212, including a proximal first electrode 2121 and a distal first electrode 2122. The proximal first electrode 2121 and the distal first electrode 2122 are spaced apart from each other along the extension direction of the first mounting member 211, and the proximal first electrode 2121 is located on the proximal side compared to the distal first electrode 2122. Along the circumferential direction of the functional component 20, the proximal first electrodes 2121 of each of the two first mounting members 211 in the paired support group are all located on the same proximal side. The first virtual weft coil 20d, the first electrodes 2122 of the distal side of each of the two first mounting members 211 in the paired support group are located on the same first virtual weft coil 20d on the distal side; at least one first monitoring member 222 on the second mounting member 221 that intersects with both the first virtual weft coil 20d on the proximal side and the first virtual weft coil 20d on the distal side has a part that coincides with the first virtual weft coil 20d on the proximal side, and another part of the first monitoring member 222 coincides with the first virtual weft coil 20d on the distal side, and the first monitoring member 222 is located in the central region 20b.

[0118] It should be noted that the proximal side and distal side here refer to the side closer to the end or the side farther from the end along the axis of the functional component.

[0119] For example, in Figure 14 , Figure 15 In the illustrated embodiment, one of any two adjacent first electrodes 212 of the three first electrodes 212 is the proximal first electrode 2121, and the other is the distal first electrode 2122. The three first electrodes 212 are respectively located on three first virtual weft coils 20d. Within the central region 20b between the two first electrodes 212 (proximal first electrodes 2121) of the proximal paired electrode group, a portion of the first monitoring element 222, such as the first measuring end 2221, is disposed, and this portion overlaps with the proximal first virtual weft coil 20d. Within the central region 20b between the two first electrodes 212 (distal first electrodes 2122) of the distal paired electrode group, another portion of the first monitoring element 222, such as the second measuring end 2222, is disposed, and this portion overlaps with the distal first virtual weft coil 20d.

[0120] For example, in Figure 16 In the illustrated embodiment, among the three first electrodes 212, the one that is closer to the end side than the other two first electrodes 212 is the proximal first electrode 2121, and the one that is closer to the distal side than the other two first electrodes is the distal first electrode 2122. An intermediate first electrode 2125 separates the proximal first electrode 2121 from the distal first electrode 2122.

[0121] Projected along the circumferential direction of the functional component 20, the first measuring end 2221 on the first monitoring element 222 and the distal first electrode 2122 at least partially overlap, and the second measuring end 2222 on the first monitoring element 222 and the proximal first electrode 2121 at least partially overlap.

[0122] In addition to the proximal pairing electrode group and the distal pairing electrode group, the first monitoring element 222 may not be provided between the two first electrodes 212 in another pairing electrode group, or the first monitoring element 222 may be provided in the central region 20b between the two first electrodes 212 in another pairing electrode group, and the first monitoring element 222 and the two first electrodes 212 in the other pairing electrode group are located on the same first virtual weft coil 20d.

[0123] It is understandable that, with 3n (n being a natural number greater than 1) paired support groups in each paired support group, every three paired support groups can be used as follows: Figures 14 to 16 The arrangement of the first monitoring element 222 is shown.

[0124] Figure 17 In this configuration, each paired support group has three paired electrode groups, and the first monitoring element 222 corresponds to two of these paired electrode groups. For example... Figure 17As shown, the three first electrodes 212 include a proximal first electrode 2123 and a distal first electrode 2124, which are spaced apart from each other along the extension direction of the first mounting member 211. The proximal first electrode 2123 and the distal first electrode 2124 are respectively located at the closest and farthest ends of all the first electrodes on the first mounting member 211. Along the circumferential direction of the functional component 20, in the proximal pairing support group, the proximal first electrodes 2123 of each of the two first mounting members 211 are located at the same first virtual weft coil 20d at the proximal end, and in the distal pairing support group, the distal first electrodes 2124 of each of the two first mounting members 211 are located at the same first virtual weft coil 20d at the distal end. A portion of the first monitoring element 222 on the second mounting member 221, which intersects both the first virtual weft coil 20d at the near end and the first virtual weft coil 20d at the far end, coincides with the first virtual weft coil 20d at the near end, and another portion of the first monitoring element 222 coincides with the first virtual weft coil 20d at the far end, and the first monitoring element 222 is located in the central region 20b.

[0125] A portion of the first monitoring element 222, such as the first measuring end 2221, overlaps with the proximal first virtual weft coil 20d. Another portion of the first monitoring element 222, such as the second measuring end 2222, overlaps with the distal first virtual weft coil 20d.

[0126] An intermediate first electrode 2125 is spaced between the proximal first electrode 2123 and the distal first electrode 2124.

[0127] In addition to the proximal pairing electrode group and the distal pairing electrode group, the first monitoring element 222 may or may not be provided between the two first electrodes 212 in other pairing electrode groups located between the proximal pairing electrode group and the distal pairing electrode group, and the first monitoring element 222 and the two first electrodes 212 in the pairing electrode group are located on the same first virtual weft coil 20d.

[0128] Understandable Figure 17 An example with three paired electrode groups is shown, but more paired electrode groups can be provided on the paired support group. That is, there can be multiple intermediate first electrodes 2125. Furthermore, without conflict, Figures 10 to 17 The illustrated embodiments can be combined.

[0129] Therefore, the voltage signal around at least one first electrode 212 can be obtained by using the first monitoring element 222. The small distance between the first monitoring element 222 and at least one first electrode 212 helps to improve the accuracy of the voltage signal collected by the measuring end.

[0130] In some embodiments, such as Figure 18As shown, when the functional component 20 is in the unfolded form, the functional component 20 defines a reference sphere, and at least one first monitoring element 222 on at least one second mounting member 221 in at least one paired support group protrudes from the reference sphere.

[0131] like Figure 18 As shown, along the circumference of the functional component 20, the virtual arc connecting line 20e between corresponding positions of the first mounting members 211 in any paired support group lies in a plane perpendicular to the extension direction of the conduit assembly 10. Along the radial direction of the functional component 20, the virtual arc connecting line 20e protrudes radially outward from the virtual weft loops between corresponding positions. The virtual connecting line of the center points of each virtual arc connecting line 20e constitutes a second virtual midline, which extends along the length direction of the functional component 20. The second mounting member 221 between the two first mounting members 211 in any paired support group at least partially coincides with the second virtual midline. The second virtual midline extends equidistantly along the virtual straight line connecting line 20f towards the first mounting members on both sides, forming an outwardly convex region.

[0132] The virtual arc connecting line 20e and the second virtual midline are both located outside the reference sphere defined by the first mounting member 211. At least one first electrode 212 on each first mounting member 211 is tangent to the same virtual circle, and at least one first monitoring member 222 on each second mounting member 221 is tangent to another virtual circle. The virtual circle tangent to the first monitoring member 222 and the virtual circle tangent to the first electrode 212 are located on the same plane, and the diameter of the virtual circle tangent to the first monitoring member 222 is larger than the diameter of the virtual circle tangent to the first electrode 212.

[0133] Therefore, the second mounting component 221 is closer to the target area than the first mounting component 211, thus enabling more accurate monitoring of the ablation status of the target area. The first mounting component 211 and the first electrode 212 can be protected within the internal space enclosed by the second mounting component 221, allowing the first electrode 212 to obtain a more stable environment.

[0134] In this case, the arrangement position between the first monitoring element 222 and the paired electrode group can be adopted as... Figures 10 to 17 The embodiment shown uses the same arrangement, except that the so-called circumferential projection of the functional component 20 is not projected along the extension direction of the first virtual latitude coil 20d, but rather along the extension direction of the virtual arc connecting line 20e. Other identical structures will not be described further here.

[0135] In other embodiments, such as Figure 19 As shown, when the functional component 20 is in the unfolded form, the functional component 20 defines a reference spherical surface, and at least one first monitoring element 222 on at least one second mounting member 221 in at least one paired support group is recessed into the reference spherical surface.

[0136] like Figure 19 As shown, along the circumference of the functional component 20, the virtual arc connecting line 20e between corresponding positions of the first mounting members 211 in any paired support group lies in a plane perpendicular to the extension direction of the conduit assembly 10. Along the radial direction of the functional component 20, the virtual straight line connecting line 20f is concave radially inward compared to the virtual weft loops between corresponding positions. The virtual connecting line of the center points of each virtual straight line connecting line 20f constitutes a third virtual midline, which extends along the length direction of the functional component 20. The second mounting member 221 between the two first mounting members 211 in any paired support group at least partially coincides with the third virtual midline. The third virtual midline extends equidistantly along the virtual straight line connecting line 20f towards the first mounting members on both sides, forming a concave region.

[0137] The virtual straight line 20f and the third virtual median line are both located within the reference sphere defined by the first mounting component 211. At least one first electrode 212 on each first mounting component 211 is tangent to the same virtual circle, and at least one first monitoring component 222 on each second mounting component 221 is tangent to another virtual circle. The virtual circle tangent to the first monitoring component 222 and the virtual circle tangent to the first electrode 212 are located on the same plane, and the diameter of the virtual circle tangent to the first monitoring component 222 is smaller than the diameter of the virtual circle tangent to the first electrode 212.

[0138] Therefore, the second mounting member 221 is farther away from the target area relative to the first mounting member 211, thereby reducing the pressure of the second mounting member 221 on the target tissue.

[0139] In this case, the arrangement position between the first monitoring element 222 and the paired electrode group can be adopted as... Figures 10 to 17 The embodiment shown uses the same arrangement, except that the so-called circumferential projection of the functional component 20 is not projected along the extension direction of the first virtual latitude coil 20d, but rather along the extension direction of the virtual straight line connection 20f. Other identical structures will not be described further here.

[0140] In some embodiments, such as Figure 20 As shown, the monitoring component 22 also includes at least one second monitoring element 223, which is disposed on at least one first mounting component 211. On the first mounting component 211 provided with the second monitoring element 223, the second monitoring element 223 and the first electrode 212 are arranged at intervals along the length extension direction of the first mounting component 211. The second monitoring element 223 is used to monitor the voltage signal of its area to determine the electric field strength of the area.

[0141] The second monitoring element 223 and the first electrode 212 are arranged at intervals. Along the extension direction of the first mounting element 211, at least one second monitoring element 223 may be located between each of the first electrodes 212, or on the distal side of the distal first electrode 2124, or on the proximal side of the proximal first electrode 2123.

[0142] Therefore, by setting the second monitoring element 223 on the first mounting component 211, a new monitoring point is added, allowing the user to obtain a more comprehensive picture of the ablation energy distribution, so that the user can determine whether the ablation requirements are met.

[0143] like Figure 20 As shown, the second monitoring device 223 includes a third measuring end 2231 and a fourth measuring end 2232, both of which are fixed to the first mounting device 211. The third measuring end 2231 and the fourth measuring end 2232 are used to collect voltage signals in their respective areas. The voltage signals obtained by the third measuring end 2231 and the fourth measuring end 2232 of the second monitoring device 223 are used to subtract from each other to obtain a voltage signal to determine the electric field strength in the area.

[0144] The second monitoring element 223 can adopt a structural form similar to that of the first monitoring element 222. For example, such as... Figure 21 As shown, the first mounting component 211 includes a third insulating tube 2233 and a fourth insulating tube 2234; the second monitoring component 223 includes a third metal wire 2235 and a fourth metal wire 2236, the third metal wire 2235 passing through the third insulating tube 2233 and the fourth metal wire 2236 passing through the fourth insulating tube 2234; the third insulating tube 2233 has a third window 2233a to expose a portion of the third metal wire 2235 as a third measuring end 2231; the fourth insulating tube 2234 has a fourth window 2234a to expose a portion of the fourth metal wire 2236 as a fourth measuring end 2232.

[0145] In one embodiment, the third measuring end 2231 and the fourth measuring end 2232 may be located on the same weft coil.

[0146] In some embodiments, a third metal component is fixed at the exposed position of the third metal wire 2235 in the third insulating tube 2233 as a third measuring end 2231; a fourth metal component is fixed at the exposed position of the fourth metal wire 2236 in the fourth insulating tube 2234 as a fourth measuring end 2232. The third and fourth metal components may be made of the same or different materials.

[0147] In some embodiments, the second monitoring element 223 may be an electric field sensor.

[0148] During ablation, the current flowing through the target area easily generates heat, especially in areas with poor blood perfusion. The heat is not easily carried away, and the gradual accumulation of heat may cause the electric field to rise above the ideal threshold. An ablation electric field with a field strength exceeding the ideal threshold can easily damage sensitive areas outside the target area, such as the area near the esophagus on the posterior wall of the left atrium in atrial fibrillation ablation surgery.

[0149] To reduce the probability of this problem occurring, in some embodiments, such as Figure 20 As shown, the monitoring component 22 also includes at least one third monitoring element 224, which is disposed on at least one first mounting component 211 and located on at least one first electrode 212 on the first mounting component 211. The third monitoring element 224 is used to monitor the voltage signal of its area to determine the electric field strength of the area.

[0150] For example, the third monitoring element 224 may be an electric field sensor.

[0151] In some embodiments, the third monitoring element 224 may be integrated with at least one first electrode 212.

[0152] Since the ablation electric field generated by the first electrode 212 is stronger closer to the first electrode 212, and the third monitoring element 224 is located on the first electrode 212, the third monitoring element 224 is located at the strongest field strength, thereby monitoring the ablation energy at the strongest field strength, which helps to reduce the probability of damage to non-target areas due to excessive field strength.

[0153] In some embodiments, such as Figure 20 As shown, the functional component 20 also includes a cover 23, which is used to fix the distal end of the first mounting member 211 and the distal end of the second mounting member 221 to the distal end of the support bar 12; the cover 23 serves as an electrode to release ablation energy.

[0154] The structure that uses the cover 23 to fix the first mounting member 211 and the second mounting member 221 to the support bar 12 will be described below.

[0155] In some embodiments, such as Figure 22 , Figure 23 As shown, the distal ends of any two adjacent first mounting members 211 are connected to each other to form a first constraint ring 2111, which is a closed ring structure. The first constraint ring 2111 is sleeved on and fixed to the support strip 12. The first constraint ring 2111 has multiple through holes arranged circumferentially along the functional component 20, and portions of each second mounting member 221 pass through the through holes.

[0156] The first constraint ring 2111 may be located at the distal end of the support bar 12. The cover 23 may cover the periphery of the first constraint ring 2111, and the cover 23 may fix the first constraint ring 2111 and the distal end of the second mounting member 221 to the distal end of the support bar 12 by interference fit with the first constraint ring 2111.

[0157] To enhance the fixing strength of the cap 23 to the first constraint ring 2111 and the second mounting member 221, in some embodiments, such as Figures 24 to 29 As shown, a constricting member 13 is provided on the support bar 12, and the constricting member 13 can be located at the distal end of the support bar 12. Along the circumference of the functional component 20, the constricting member 13 has a plurality of alternately distributed constricting holes 132a and a plurality of locking grooves 132b. The constricting holes 132a are parallel to the extension direction of the conduit assembly 10, and the locking grooves 132b are open to the distal end. The inner wall of the cover 23 is provided with a plurality of locking protrusions 231 corresponding one-to-one with the locking grooves 132b. Each second mounting member 221 passes through a constricting hole 132a and is interference-fitted with the constricting hole 132a. A portion of the first mounting member 211 is accommodated in the locking groove 132b. The cover 23 is placed on the far end of the support bar 12. The inner wall of the cover 23 surrounds the gathering hole 132a, the first mounting member 211 and the second mounting member 221. The locking protrusion 231 abuts against the first mounting member 211 from the opening of the locking groove 132b to fix part of the first mounting member 211 relative to the support bar 12.

[0158] In one embodiment, such as Figure 25 As shown, the bottom of the slot 132b can be constructed as an inclined surface with a larger distance between the near end and the support bar 12.

[0159] For example, the retractable member 13 includes a connecting portion 131 and a retractable portion 132, with the connecting portion 131 fixed relative to the support bar 12. The retractable portion 132 is disposed on the periphery of the connecting portion 131, and the retractable portion 132 has a retractable hole 132a and a locking groove 132b.

[0160] In one embodiment, the ablation catheter can be introduced into the human body via a guidewire. To achieve cooperation with the guidewire, the support strip 12 can be constructed as a hollow tube, for example, by creating a support strip 12 channel extending along its own extension direction within the support strip 12. The support strip 12 channel can be used to accommodate the connecting part 131, and the support strip 12 and the connecting part 131 can be connected by means of interference fit, bonding, or other methods.

[0161] In one embodiment, such as Figure 29 As shown, a channel for the connecting portion 131 is formed in the connecting portion 131, which extends along the extension direction of the support bar 12. The proximal end of the channel wall can be configured to gradually widen towards the proximal end; and / or, the distal end of the channel wall can be configured to gradually widen towards the distal end.

[0162] In some embodiments, such as Figure 28 As shown, a sealing ring 14 can be provided between the inner wall of the cover 23 and the retaining member 13.

[0163] The proximal ends of any two adjacent first mounting members 211 are connected to each other to form a second constraint ring 2112, which is a closed ring structure. The second constraint ring 2112 can be constructed in a structure similar to that of the first constraint ring 2111, or it can be constructed in a different structure. For example, the radial dimension of the second constraint ring 2112 is smaller than that of the first constraint ring 2111, and a receiving groove is formed on the radially outward surface of the second constraint ring 2112, the extending direction of the receiving groove being parallel to the extending direction of the conduit assembly 10. The proximal end of each second mounting member 221 is received in the receiving groove and fixed relative to the second constraint ring 2112.

[0164] This ensures that the distal ends of both the first mounting component 211 and the second mounting component 221 can be securely fixed. The cap 23, acting as an electrode, generates an ablation electric field at the distal end of the ablation catheter, providing more ablation site options. In conjunction with the first electrode 212, it helps reduce ablation dead zones. For example, in atrial fibrillation ablation surgery, the functional component 20 is in an expanded state, and the cap 23 can ablate or supplement the ablation of the posterior atrial wall.

[0165] In some embodiments, when projected along the axial direction of the functional component 20, one end of each first mounting member 211 in the length direction coincides with the other end. Of course, when projected along the axial direction of the functional component 20, one end of the first mounting member 211 in the length direction may not coincide with the other end. For example, there may be a certain degree of deflection.

[0166] In some embodiments, such as Figure 30 As shown, along the axial projection of the functional component 20, one end of each first mounting member 211 in the length direction is provided with a first angle relative to the other end in a first direction along the circumference of the functional component 20, so that the axis 211a of the first mounting member and the central axis 20c of the functional component present a first angle.

[0167] The first direction can be consistent with the circumferential direction, including clockwise and counterclockwise directions in the circumferential direction. The axial direction of the functional component 20 is parallel to the axis of the catheter assembly 10, and the central axis 20c of the functional component coincides with the central axis of the catheter assembly 10.

[0168] In one embodiment, such as Figure 31 As shown, along the axial projection of the functional component 20, the distal end of each first mounting member 211 in the length direction is provided with a first angle relative to the proximal end in a first direction along the circumference of the functional component 20, so that the axis 211a of the first mounting member and the central axis 20c of the functional component present a first angle.

[0169] Therefore, during the process of the functional component 20 changing between the unfolded and retracted forms, at least one of the first mounting member 211 and the second mounting member 221 can be deflected at a preset angle, thereby providing a more stable form change and making it less prone to jamming.

[0170] In some embodiments, when projected along the axial direction of the functional component 20, one end of each second mounting member 221 in the length direction is provided with a second angle relative to the other end in a second direction along the circumferential direction of the functional component 20, so that the axis 221a of the second mounting member presents a second angle with the central axis 20c of the functional component.

[0171] The second direction can be consistent with the circumferential direction, including clockwise and counterclockwise directions within the circumferential direction.

[0172] The second angle can be the same as or different from the first angle.

[0173] In some embodiments, the deflection direction of the first mounting member 211 is the same as the deflection direction of the second mounting member 221.

[0174] In one embodiment, when projected along the axial direction of the functional component 20, the distal end of each second mounting member 221 in the length direction is provided with a second angle relative to the proximal end in a second direction along the circumference of the functional component 20, so that the axis 221a of the second mounting member presents a second angle with the central axis 20c of the functional component.

[0175] Therefore, during the process of the functional component 20 changing between the unfolded and retracted forms, at least one of the first mounting member 211 and the second mounting member 221 can be deflected at a preset angle, thereby providing a more stable form change and making it less prone to jamming.

[0176] In some embodiments, when projected along the axial direction of the functional component 20, one end of each first mounting member 211 in the length direction is provided with a first angle relative to the other end in a first direction of the circumference of the functional component 20, and one end of each second mounting member 221 in the length direction is provided with a second angle relative to the other end in a second direction of the circumference of the functional component 20.

[0177] Therefore, during the process of the functional component 20 changing between the unfolded and retracted forms, both the first mounting member 211 and the second mounting member 221 can be deflected and deformed at a preset angle, thereby providing a relatively stable form change and making it less prone to jamming.

[0178] In some embodiments, on a reference circumference at the distal end of the functional component 20, the arc length corresponding to the first angle is defined as the first distance, and the arc length corresponding to the second angle is defined as the second distance; the first distance and the second distance are the same, and the first distance is in the range of 0.5 mm to 2 mm.

[0179] On the reference circumference at the distal end of the functional component 20, the arc length of the arc segment corresponding to the first angle is the first distance. In other words, the projections of the two ends of the first mounting member 211 fall on the two endpoints of the arc segment corresponding to the first angle, respectively.

[0180] On the reference circumference at the distal end of the functional component 20, the arc length of the arc segment corresponding to the second angle is the second distance. In other words, the projections of the two ends of the second mounting member 221 fall on the two endpoints of the arc segment corresponding to the second angle, respectively.

[0181] In some embodiments, the first angle and the second angle are the same, and the first distance and the second distance are the same.

[0182] The first distance / second distance can be in the range of 0.5mm to 2mm. For example, the first distance can be 0.5mm, 0.8mm, 1.3mm, 1.5mm, 2mm, etc.

[0183] This application also provides an ablation system, which may include the ablation catheter described in the above embodiments. Further details are omitted here. Because it includes the aforementioned ablation catheter, voltage signals can be monitored in real time before and during ablation. This allows the user to determine the ablation range and intensity based on the voltage signal, and to adjust the ablation strategy accordingly. For example, rotating the ablation catheter can change the position of the first electrode 212, allowing the first electrode 212 to act on areas with lower field strength for supplementary ablation, thereby facilitating continuous, transmural, and thorough ablation.

[0184] In some embodiments, during the release of ablation energy, the controller acquires the voltage signal of the area where the monitoring position is located, and outputs a first warning signal when the voltage signal is greater than or equal to a preset threshold.

[0185] The ablation system may also include an output device, which is used to provide prompts to the user. For example, the output device may be a display screen, a speaker, etc.

[0186] The output device and the controller are connected in communication. The controller can determine whether the voltage signal is greater than the preset threshold. If the voltage signal is greater than the preset threshold, it means that the energy of the ablation field is too high. The controller controls the output device to output the first warning signal so that the user can be informed of the situation and make timely adjustments.

[0187] This application also provides an ablation monitoring method applied to an ablation catheter. The ablation catheter includes a longitudinally extending proximal end and a distal end, and further includes: a catheter assembly 10, including a main tube 11 and a support strip 12, the support strip 12 passing through the main tube and the two being axially movable relative to each other; a functional component 20, the distal end of the functional component 20 being connected to the support strip 12, and the proximal end of the functional component 20 being connected to the main tube 11, the proximal and distal ends of the functional component 20 being able to move closer or further apart as the support strip 12 and the main tube 11 move relative to each other axially, and the functional component 20 being able to radially expand or contract; the functional component 20 includes an ablation member 21 and a monitoring member 22; the ablation member 21 includes at least two first mounting members 211, and at least one first electrode 212 for releasing ablation energy is provided on the first mounting member 211; two circumferentially adjacent first mounting members 211 form a paired support group, and one of the first mounting members 211 in the paired support group has a first electrode 212 on it. Electrode 212 has a first polarity, and another first electrode 212 of another first mounting member 211 has a second polarity. A first electrode 212 with the first polarity and a first electrode 212 with the second polarity on a paired support group form a paired electrode group. At least one paired electrode group is provided on the paired support group. The monitoring member 22 includes at least one second mounting member 221. At least one first monitoring member 222 is provided on the at least one second mounting member 221. The first monitoring member 222 is used to monitor the voltage signal of its area to determine the electric field strength of the area. At least one second mounting member 221 is arranged between two first mounting members 211 in at least one paired support group. The first mounting members 211 and the second mounting members 221 are distributed at circumferential intervals along the functional component 20. A first monitoring member 222 on the second mounting member 221 is correspondingly disposed between at least one paired electrode group on its paired support group. Figure 32 As shown, ablation monitoring methods include: S101: Acquire the voltage signal detected by the first monitoring component of the target; S102: If the voltage signal is greater than or equal to the preset value (S102a), then output the first warning signal (S102b).

[0188] The preset value can be the maximum voltage value that meets the ablation requirements. If the voltage signal is greater than the preset value, it may cause damage to tissues other than the target tissue. The output warning signal will remind the user in time.

[0189] Because the first monitoring element 222 is located within the ablation electric field, it can monitor the voltage signal, allowing the user to determine the ablation range and intensity based on the voltage signal. This helps to ensure precise and thorough ablation within a controllable voltage range. The ablation monitoring method can promptly determine whether the electric field value exceeds the upper limit and notify the user, facilitating timely response and subsequent operations.

[0190] In some embodiments, such as Figure 33 As shown, the monitoring position of the first monitoring device 222 includes a first measuring terminal 2221 and a first measuring terminal 2222, which acquires the voltage signal detected by the target first monitoring device 222, including: S1011: Acquire the first voltage signal measured at the first measuring terminal; S1012: Acquire the second voltage signal measured at the second measuring terminal; S1013: Subtract the first voltage signal from the second voltage signal to obtain the voltage signal of the monitoring position of the first monitoring device.

[0191] The voltage signal of the monitoring position of the first monitoring element 222 is used to determine the intensity of the ablation energy in the area where the monitoring position of the first monitoring element 222 is located.

[0192] The spatial distance between the first measuring end 2221 and the second measuring end 2222 is the length of the straight line connecting the first measuring end 2221 and the second measuring end 2222. After the first measuring end 2221 and the second measuring end 2222 are fixed relative to the second mounting member 221, the spatial distance between them is a fixed value. Based on the spatial distance between the first measuring end 2221 and the second measuring end 2222 and the voltage difference measured by them respectively, the average electric field strength value between the first measuring end 2221 and the second measuring end 2222 can be obtained. This average electric field strength value can be regarded as the voltage signal detected by the first monitoring device.

[0193] For example, the difference between the first voltage signal and the second voltage signal is the potential difference between the first measuring terminal 2221 and the second measuring terminal 2222, and the average field strength between the first measuring terminal 2221 and the second measuring terminal 2222 is equal to the potential difference divided by the spatial spacing.

[0194] This allows users to determine whether the ablation requirements are met.

[0195] In addition to detecting the voltage signal in the area between the two first electrodes 212 in the paired electrode group through the first monitoring element 222, monitoring elements can also be set at other locations to detect voltage signals at other locations, providing detection results with a wider coverage.

[0196] In some embodiments, such as Figure 34 As shown, the monitoring component 22 further includes at least one second monitoring element 223, which is disposed on at least one first mounting member 211. On the first mounting member 211 where the second monitoring element 223 is provided, the second monitoring element 223 and the first electrode 212 are arranged at intervals along the extending direction of the first mounting member 211. The method further includes: S201: Acquire the voltage signal detected by the second monitoring component of the target; S102: If the voltage signal is greater than or equal to the preset electric field value, output a first warning signal, including: S1022: Compare the voltage signal detected by the first monitoring device with the voltage signal detected by the second monitoring device, and take the larger one as the detection result (S1022a). If the detection result is greater than the preset value (S1022b), then output the first warning signal.

[0197] Therefore, by setting the second monitoring element 223 on the first mounting component 211, additional monitoring points are added, allowing the user to obtain a more comprehensive picture of the ablation energy distribution. By comparing the voltage signal at the first monitoring element 222 and the voltage signal at the second monitoring element 223, and using the larger value as the detection result, it helps to ensure that most locations of the ablation electric field are within the controllable ablation threshold.

[0198] In some embodiments, such as Figure 35 As shown, the monitoring position of the second monitoring device 223 includes a third measuring end 2231 and a fourth measuring end 2232. Acquire the voltage signal detected by the second monitoring device of the target, including: S2011: Acquire the third voltage signal measured at the third measuring terminal; S2012: Acquire the fourth voltage signal measured at the fourth measuring terminal; S2013: Subtract the third voltage signal from the fourth voltage signal to obtain the voltage signal of the monitoring position of the second monitoring device.

[0199] The voltage signal of the monitoring position of the second monitoring element 223 is used to determine the intensity of the ablation energy in the area where the monitoring position of the second monitoring element 223 is located.

[0200] The spatial distance between the third measuring terminal 2231 and the fourth measuring terminal 2232 is the length of the straight line connecting the third measuring terminal 2231 and the fourth measuring terminal 2232. After the third measuring terminal 2231 and the fourth measuring terminal 2232 are fixed relative to the second mounting member 221, the spatial distance between them is a fixed value. Based on the spatial distance between the third measuring terminal 2231 and the fourth measuring terminal 2232 and the voltage difference measured by them respectively, the average electric field strength value between the third measuring terminal 2231 and the fourth measuring terminal 2232 can be obtained. This average electric field strength value can be regarded as the voltage signal detected by the second monitoring member.

[0201] For example, the difference between the third voltage signal and the fourth voltage signal is the potential difference between the third measuring terminal 2231 and the fourth measuring terminal 2232, and the average field strength between the third measuring terminal 2231 and the fourth measuring terminal 2232 is equal to the potential difference divided by the spatial spacing.

[0202] This allows users to determine whether the ablation requirements are met.

[0203] In some embodiments, such as Figure 36 As shown, the monitoring component 22 further includes at least one third monitoring element 224, which is disposed on at least one first electrode 212. The method also includes: S301: Acquire the voltage signal detected by the third monitoring device of the target; S102: If the voltage signal is greater than or equal to a preset value, output a first warning signal, including: S1023: Compare the voltage signals of the first monitoring device, the second monitoring device, and the third monitoring device, and take the largest one as the detection result (S1023a). If the detection result is greater than or equal to the preset value (S1023b), then output the first warning signal.

[0204] Of course, it is also possible to determine the relationship between the voltage signal of the third monitoring device and the preset value. If the voltage signal of the third monitoring device exceeds the preset value, it can be determined that the field strength of the ablation electric field is too large, which may damage sensitive parts outside the target area, and output the first warning signal.

[0205] Users can adjust the electric field strength or turn off the first electrode 212 themselves according to the warning information, or the controller can automatically adjust the electric field strength or turn off the first electrode 212.

[0206] Therefore, the strength of the ablation electric field can be determined by measuring the electric field values ​​at multiple monitoring locations to determine whether the intensity is within an appropriate range.

[0207] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Any modifications, equivalent substitutions, and improvements made within the spirit and scope of this application are included within the scope of protection of this application.

Claims

1. An ablation catheter, comprising a longitudinally extending proximal end and a distal end, characterized in that, Also includes: A conduit assembly includes a main tube and a support strip, the support strip being inserted through the main tube and the two being axially movable relative to each other; A functional component, wherein the distal end of the functional component is connected to the support bar, and the proximal end of the functional component is connected to the main body tube. The proximal end and the distal end of the functional component can move closer or further away as the support bar and the main body tube move relative to each other along the axial direction. Furthermore, the functional component can be radially extended or contracted. The functional components include an ablation component and a monitoring component; the ablation component includes at least two first mounting members, and at least one first electrode for releasing ablation energy is disposed on the first mounting member. Two circumferentially adjacent first mounting members serve as a pairing support group. One first electrode on one of the first mounting members of the pairing support group has a first polarity, and one first electrode on the other first mounting member has a second polarity. The first electrode with the first polarity and the first electrode with the second polarity on the pairing support group form a pairing electrode group. At least one pairing electrode group is provided on the pairing support group. The monitoring component includes at least one second mounting component, and at least one first monitoring component is provided on the at least one second mounting component. The first monitoring component is used to monitor the voltage signal of its area to determine the electric field strength of the area. At least one second mounting member is arranged between two first mounting members in at least one of the paired support groups, and the first mounting members and the second mounting members are distributed at circumferential intervals along the functional components; One of the first monitoring elements on the second mounting component is correspondingly disposed between at least one of the paired electrode groups on the paired support group to which it is located.

2. The ablation catheter according to claim 1, characterized in that, The area in question is a localized region within the target area of ​​the ablation energy effect.

3. The ablation catheter according to claim 2, characterized in that, Along the circumference of the functional component, the virtual line connecting the center points of the two first mounting members in the paired support group forms a central meridian, which extends along the length of the functional component. Along the circumference of the functional component, the mating support group has a central region, which is formed by the first mounting members extending equidistantly from the central meridian to both sides. The circumferential length of the central region is 1-20% of the maximum circumferential length between the two first mounting members in the mating support group. The central region is located between the paired electrode groups in the corresponding paired support group, and at least one of the first monitoring elements on the second mounting member in at least one of the paired support groups is located in the central region corresponding to the paired support group.

4. The ablation catheter according to claim 2, characterized in that, The monitoring component includes at least two of the second mounting components; The at least two first mounting members and the at least two second mounting members are alternately distributed along the circumference of the functional component, such that a second mounting member is provided between two circumferentially adjacent first mounting members of the functional component.

5. The ablation catheter according to claim 4, characterized in that, The second mounting member between the two first mounting members in the paired support group is located in the central area of ​​the corresponding paired support group.

6. The ablation catheter according to claim 2, characterized in that, The first electrode can switch between the first polarity and the second polarity, and the first polarity and the second polarity may be the same or different.

7. The ablation catheter according to claim 6, characterized in that, The first polarity and the second polarity are different. The paired electrode group is used to release the ablation energy, and the first monitoring element is used to monitor the voltage signal in its area.

8. The ablation catheter according to claim 7, characterized in that, Projected circumferentially along the functional component, the two first electrodes on the paired electrode group at least partially overlap.

9. The ablation catheter according to claim 2, characterized in that, When the functional component is in the unfolded form, the functional component defines a reference sphere, on which at least one first monitoring element on at least one of the second mounting members of at least one of the paired support groups is located, protruding from, or recessed into the reference sphere.

10. The ablation catheter according to claim 9, characterized in that, The reference sphere is spherical or rugby ball-shaped.

11. The ablation catheter according to any one of claims 1 to 10, characterized in that, The first monitoring device includes a first measuring end and a second measuring end, both of which are fixed to the second mounting device; The first measuring end is used to acquire a first voltage signal in its area, and the second measuring end is used to acquire a second voltage signal in its area. The first voltage signal and the second voltage signal are used to subtract from each other to obtain the voltage signal.

12. The ablation catheter according to claim 11, characterized in that, The second mounting component includes a first insulating tube and a second insulating tube; The second mounting component also includes a first metal wire and a second metal wire, wherein the first metal wire passes through the first insulating tube and the second metal wire passes through the second insulating tube; The first insulating tube has a first window to expose a portion of the first metal wire as the first measuring end; The second insulating tube has a second window to expose a portion of the second metal wire as the second measuring end; The first metal wire and the second metal wire may be made of the same or different materials.

13. The ablation catheter according to claim 12, characterized in that, A first metal component is fixed at the exposed position of the first metal wire in the first insulating tube as the first measuring end; A second metal component is fixed at the exposed position of the second metal wire in the second insulating tube as the second measuring end; The first metal part and the second metal part may be made of the same or different materials.

14. The ablation catheter according to claim 11, characterized in that, Projected circumferentially along the functional component, one of the first monitoring elements on the second mounting piece at least partially overlaps with at least one of the first electrodes on its corresponding paired electrode group.

15. The ablation catheter according to claim 14, characterized in that, A first monitoring element on the second mounting component is correspondingly disposed on a pairing electrode group on the pairing support group to which it is located. When projected circumferentially along the functional component, the first measuring end and the second measuring end on the first monitoring element at least partially overlap with at least one first electrode on the corresponding pairing electrode group.

16. The ablation catheter according to claim 15, characterized in that, For a pair of electrodes corresponding to the first monitoring device, when projected circumferentially along the functional component, the first measuring end and the second measuring end on the first monitoring device at least partially overlap with the two first electrodes on the corresponding pair of electrodes.

17. The ablation catheter according to claim 14, characterized in that, One of the first monitoring elements on the second mounting component is correspondingly provided with two of the paired electrode groups on the paired support group to which it is located. When projected circumferentially along the functional component, the first measuring end on the first monitoring element and at least one first electrode on one of the paired electrode groups at least partially overlap, and the second measuring end on the first monitoring element and at least one first electrode on the other paired electrode group at least partially overlap.

18. The ablation catheter according to claim 17, characterized in that, For the two paired electrode groups corresponding to the first monitoring device, when projected circumferentially along the functional component, the first measuring end on the first monitoring device and the two first electrodes on one of the paired electrode groups at least partially overlap, and the second measuring end on the first monitoring device and the two first electrodes on the other paired electrode group at least partially overlap.

19. The ablation catheter according to any one of claims 1 to 10, characterized in that, The monitoring component further includes at least one second monitoring element, which is disposed on at least one of the first mounting components; On the first mounting component equipped with the second monitoring element, the second monitoring element and the first electrode are arranged at intervals along the length extension direction of the first mounting component; the second monitoring element is used to monitor the voltage signal of its area to determine the electric field strength of the area.

20. The ablation catheter according to any one of claims 2 to 10, characterized in that, The monitoring component further includes at least one third monitoring element, which is disposed on at least one first mounting component and located on at least one first electrode on the first mounting component; the third monitoring element is used to monitor the voltage signal of its area to determine the electric field strength of the area.

21. The ablation catheter according to any one of claims 1 to 10, characterized in that, The functional component further includes a cover, which is used to fix the distal end of the first mounting member and the distal end of the second mounting member to the distal end of the support strip. The cap acts as an electrode to release ablation energy.

22. The ablation catheter according to any one of claims 1 to 10, characterized in that, Projected along the axial direction of the functional component, one end of each first mounting member along the length direction of the functional component is provided with a first angle relative to the other end in a first direction along the circumference of the functional component, so that the axis of the first mounting member and the central axis of the functional component present the first angle. Projected along the axial direction of the functional component, one end of each second mounting member along the length direction of the functional component is provided with a second angle relative to the other end in a second direction along the circumference of the functional component, so that the axis of the second mounting member and the central axis of the functional component present the second angle; The first direction and the second direction are the same, and the first angle and the second angle are the same or different.

23. The ablation catheter according to claim 22, characterized in that, Projected along the axial direction of the functional component, the distal end of each first mounting member in the length direction is provided with a first angle relative to the proximal end in a first direction along the circumference of the functional component, so that the axis of the first mounting member and the central axis of the functional component present the first angle. Projected along the axial direction of the functional component, the distal end of each second mounting member in the length direction is provided with a second angle relative to the proximal end in a second direction along the circumference of the functional component, so that the axis of the second mounting member and the central axis of the functional component present the second angle. The first direction and the second direction are the same, and the first angle and the second angle are the same or different.

24. The ablation catheter according to claim 23, characterized in that, On a reference circle at the far end of the functional component, the arc length corresponding to the first angle is defined as the first distance, and the arc length corresponding to the second angle is defined as the second distance; the first distance and the second distance are the same, and the first distance is in the range of 0.5mm to 2mm.

25. An ablation system, characterized in that, include: An ablation catheter, including a longitudinally extending proximal end and a distal end, the ablation catheter further comprising: A conduit assembly includes a main tube and a support strip, the support strip being inserted through the main tube and the two being axially movable relative to each other; A functional component, wherein the distal end of the functional component is connected to the support bar, and the proximal end of the functional component is connected to the main body tube. The proximal end and the distal end of the functional component can move closer or further away as the support bar and the main body tube move relative to each other along the axial direction. Furthermore, the functional component can be radially extended or contracted. The functional components include an ablation component and a monitoring component; the ablation component includes at least two first mounting members, and at least one first electrode for releasing ablation energy is disposed on the first mounting member; Two circumferentially adjacent first mounting members serve as a pairing support group. One first electrode on one of the first mounting members of the pairing support group has a first polarity, and one first electrode on the other first mounting member has a second polarity. The first electrode with the first polarity and the first electrode with the second polarity on the pairing support group form a pairing electrode group. At least one pairing electrode group is provided on the pairing support group. The monitoring component includes at least one second mounting component, and at least one first monitoring component is provided on the at least one second mounting component for monitoring the voltage signal of its area to determine the electric field strength of the area. At least one second mounting member is arranged between two first mounting members in at least one of the paired support groups, and the first mounting members and the second mounting members are distributed at circumferential intervals along the functional components; One of the first monitoring elements on the second mounting component is correspondingly disposed on at least one of the paired electrode groups on the paired support group to which it is located; A controller is communicatively connected to the ablation catheter. The controller outputs a drive signal, which is used to cause the first electrode on the ablation catheter to release ablation energy.

26. The ablation system according to claim 25, characterized in that, Along the circumference of the functional component, the virtual line connecting the center points of the two first mounting members in the paired support group forms a central meridian, which extends along the length of the functional component. Along the circumference of the functional component, the mating support group has a central region, which is formed by the first mounting members extending equidistantly from the central meridian to both sides. The circumferential length of the central region is 1-20% of the maximum circumferential length between the two first mounting members in the mating support group. The central region is located between the paired electrode groups in the corresponding paired support group, and at least one of the first monitoring elements in at least one of the paired support groups is located in the central region of the corresponding paired support group.

27. The ablation system according to claim 26, characterized in that, The monitoring component includes at least two of the second mounting components; The at least two first mounting members and the at least two second mounting members are alternately distributed along the circumference of the functional component, such that a second mounting member is provided between two circumferentially adjacent first mounting members of the functional component.

28. The ablation system according to claim 26, characterized in that, When the functional component is in the unfolded form, the functional component defines a reference sphere, on which at least one first monitoring element on at least one of the second mounting members of at least one of the paired support groups is located, protruding from, or recessed into the reference sphere.

29. The ablation system according to any one of claims 25 to 28, characterized in that, During the release of the ablation energy, the controller acquires the voltage signal of the area where the monitoring position is located, and outputs a first warning signal when the voltage signal is greater than or equal to a preset threshold.

30. An ablation monitoring method, characterized in that, Application in ablation catheters; The ablation catheter includes a longitudinally extending proximal end and a distal end. The ablation catheter further includes: a catheter assembly including a main tube and a support strip, the support strip passing through the main tube and the two being axially movable relative to each other; a functional component, the distal end of the functional component being connected to the support strip, the proximal end of the functional component being connected to the main tube, the proximal end and the distal end of the functional component being able to move closer or further away as the support strip and the main tube move relative to each other axially, and the functional component being able to radially expand or contract. The functional component includes an ablation component and a monitoring component. The ablation component includes at least two first mounting members, each with at least one first electrode for releasing ablation energy. Two circumferentially adjacent first mounting members form a paired support group. One first electrode on one of the first mounting members in the paired support group has a first polarity, and one first electrode on the other first mounting member has a second polarity. The first electrode with the first polarity and the first electrode with the second polarity on the paired support group form a paired electrode group. At least one paired electrode group is provided on the paired support group. The monitoring component includes at least one second mounting member, each with at least one first monitoring element. The first monitoring element monitors the voltage signal in its area to determine the electric field strength in that area. At least one second mounting member is arranged between two first mounting members in at least one paired support group. The first and second mounting members are distributed at circumferential intervals along the functional component. A first monitoring element on a second mounting member is correspondingly positioned between at least one paired electrode group on its paired support group. The method includes: Acquire the voltage signal detected by the first monitoring component of the target; If the voltage signal is greater than or equal to a preset value, a first warning signal is output.

31. The ablation monitoring method according to claim 30, characterized in that, The monitoring position of the first monitoring device includes a first measuring end and a first measuring terminal. Acquire the voltage signal detected by the first monitoring device of the target, including: Acquire the first voltage signal measured at the first measuring terminal; Acquire the second voltage signal measured at the second measuring terminal; The voltage signal is obtained by subtracting the first voltage signal from the second voltage signal, and the voltage signal is used to determine the intensity of the ablation energy in the area where the monitoring position is located.

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