Ablation catheter and ablation system

Abstract

The application discloses an ablation catheter and an ablation system. The ablation catheter comprises an outer tube, an inner tube, a first ablation assembly and a second ablation assembly. The inner tube is coaxially movably arranged in the outer tube. The first ablation assembly is arranged at the distal end of the inner tube and is used for point ablation of a target tissue region. The second ablation assembly is arranged at the proximal end of the first ablation assembly, and the proximal end of the second ablation assembly is connected to the distal end of the outer tube. The second ablation assembly is used for ring ablation of the target tissue region. The ablation catheter and the ablation system integrate the point ablation and the ring ablation functions, can be used for ablation treatment of persistent atrial fibrillation, meet the ablation requirements of any position of a heart, and have high ablation efficiency.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an ablation catheter and ablation system. Background Technology

[0002] The development of persistent atrial fibrillation remains a highly complex process, with its main mechanisms categorized into triggering and maintenance mechanisms. Triggering mechanisms include ganglion plexuses, Marshall's ligament, coronary sinus muscle sleeves, non-pulmonary vein triggers, and pulmonary vein muscle sleeves. Maintenance mechanisms include fragmented potential areas, cardiac myocardial fibrosis, and low-potential areas under sinus rhythm. Different treatment strategies are available for each of these mechanisms.

[0003] For patients with persistent atrial fibrillation triggering multiple mechanisms, after pulmonary vein isolation, it is necessary to perform ablation on areas such as the left atrial roof, mitral valve, and tricuspid valve. However, in current procedures, ablation and pulmonary vein isolation are performed using different ablation catheters, resulting in a long overall procedure time and low ablation efficiency. Therefore, there is an urgent need for a medical device that can perform both pulmonary vein isolation and ablation. Summary of the Invention

[0004] The purpose of this application is to provide an ablation catheter and ablation system that integrate point ablation and ring ablation functions, which can be used for ablation treatment of persistent atrial fibrillation, meet the ablation needs of any location in the heart, and have high ablation efficiency.

[0005] In a first aspect, this application provides an ablation catheter, comprising an outer tube, an inner tube, a first ablation component, and a second ablation component. The inner tube is coaxially and movably inserted within the outer tube. The first ablation component is located at the distal end of the inner tube and is used for point-like ablation of the target tissue area. The second ablation component is located at the proximal end of the first ablation component, and its proximal end is connected to the distal end of the outer tube. The second ablation component is used for circumferential ablation of the target tissue area.

[0006] Secondly, this application provides an ablation system, which includes a pulse ablation device and an ablation catheter as described above, wherein the ablation catheter is connected to the pulse ablation device.

[0007] This application provides an ablation catheter and ablation system. The ablation catheter is equipped with a first ablation component and a second ablation component. The first ablation component can perform point ablation on the target tissue area, and the second ablation component can perform ring ablation on the target tissue area. This integrates point ablation and ring ablation functions, allowing both point ablation and ring ablation to be achieved during the procedure. It can be used for ablation treatment of persistent atrial fibrillation, meeting the ablation needs of any location on the heart, while improving ablation efficiency. Attached Figure Description

[0008] Figure 1 This is a schematic diagram of the structure of a pulse ablation system provided in this application;

[0009] Figure 2 yes Figure 1 The diagram shows a partial structural schematic of the ablation catheter in one usage state.

[0010] Figure 3 yes Figure 2 The diagram shows a cross-sectional view of the ablation catheter cut along point AA.

[0011] Figure 4 yes Figure 2 The diagram shows the structure of the second ablation component.

[0012] Figure 5 yes Figure 2 The diagram shows the structure of the first ablation component.

[0013] Figure 6 yes Figure 5 The diagram shows a cross-sectional view of the first ablation component cut along point BB.

[0014] Figure 7 yes Figure 2 A schematic diagram of the ablation catheter from another angle is shown.

[0015] Figure 8 yes Figure 1 The diagram shows the structure of the ablation catheter in two different application scenarios;

[0016] Figure 9 yes Figure 1 The diagram shows a partial structural representation of the ablation catheter in another application scenario.

[0017] Figure 10 This is a schematic diagram of the structure of an ablation catheter provided in this application under different usage states in some embodiments;

[0018] Figure 11 This is a partial structural schematic diagram of an ablation catheter provided in this application in some other embodiments;

[0019] Figure 12 yes Figure 11 A schematic diagram of the cross-sectional structure of the ablation catheter cut along the CC section.

[0020] Figure 13 This is a partial structural schematic diagram of an ablation catheter provided in this application in some embodiments;

[0021] Figure 14 yes Figure 13 The diagram shows the structure of the ablation catheter from another angle. Detailed Implementation

[0022] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0023] In the description of this application, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances. The term "and / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone.

[0024] In the description of this specification, the use of terms such as "embodiment," "specific embodiment," and "example" refers to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0025] For ease of description, in the field of endovascular interventional therapy, "proximal" refers to the end of the instrument that is closer to the operator after the interventional procedure, and "distal" refers to the end of the instrument that is farther away from the operator after the interventional procedure. "Proximal" and "distal" are non-limiting directional descriptions.

[0026] The ablation catheter and ablation system of this application have a first ablation component capable of point ablation of the target tissue area and a second ablation component capable of ring ablation of the target tissue area, thus integrating point ablation and ring ablation functions. This allows the ablation catheter to perform both point ablation and ring ablation during the procedure, making it suitable for ablation treatment of persistent atrial fibrillation, meeting the ablation needs of any location on the heart, and improving ablation efficiency.

[0027] In practical use, the ablation catheter of this application can be delivered percutaneously through the ablation sheath to specific locations in the heart, such as the mitral isthmus, tricuspid isthmus, top of the left atrium, pulmonary veins, left atrial appendage, or triggering foci (such as superior vena cava or coronary sinus ostium) with typical atrial flutter for ablation.

[0028] It should be noted that the target tissue area for point ablation by the first ablation component and the target tissue area for ring ablation by the second ablation component can be the same or different. For example, the target tissue area for point ablation by the first ablation component is the top of the left atrium, and the target tissue area for ring ablation by the second ablation component is the pulmonary vein. Or, for another example, the target tissue area for point ablation by the first ablation component and the target tissue area for ring ablation by the second ablation component are both the pulmonary vein. If local abnormal potentials still exist after ring ablation of the pulmonary vein using the second ablation component, point ablation of the pulmonary vein can be performed using the first ablation component.

[0029] Please see Figure 1 , Figure 1 This is a schematic diagram of the structure of a pulse ablation system 100 provided in this application.

[0030] In some embodiments, the pulse ablation system 100 includes an ablation catheter 10, a pulse ablation device 30, a junction box 40, a three-dimensional mapping system 50, and a multi-channel recorder 60. The ablation catheter 10 is connected to the pulse ablation device 30 via ablation lines 20a and mapping lines 20b. The mapping lines 20b of the ablation catheter 10 are also connected to the junction box 40, the three-dimensional mapping system 50, and the multi-channel recorder 60, respectively. The ablation catheter 10 can be used for point ablation of areas such as the mitral isthmus, tricuspid isthmus, left atrial roof line, left atrial posterior wall line, fragmented potential area, and the large ring surrounding the pulmonary veins, as well as for ring ablation of areas such as the pulmonary vein orifices.

[0031] In some embodiments, the pulse ablation device 30 includes a user interface, a pulse generator, a controller, and a data storage module. The user interface indicates various operations of the pulse ablation device 30 and information such as the area to be ablated, facilitating operation. The pulse generator emits pulse ablation energy. The data storage module stores executable instructions to cooperate with the controller in performing the operations described in this embodiment. Under three-dimensional mapping, the operator can operate the pulse ablation device 30 to control the ablation catheter 10 to reach the low-voltage area or focal point of the patient's heart for precise ablation, thereby blocking the conduction of abnormal electrical signals.

[0032] In some embodiments, the 3D mapping system 50 employs electric field modeling combined with electrocardiogram (ECG) mapping. Electric field modeling is achieved through surface leads, which involve attaching electrodes to various parts of the body to create orthogonal electric fields and generate surface ECGs. After the ablation catheter 10 enters the orthogonal electric field, it forms a loop with the internal circuitry of the 3D mapping system 50, thereby forming a 3D model. Furthermore, the ablation catheter 10 can also acquire ECG signals, which, when combined with the 3D model, form a complete heart model. The 3D mapping system 50 can also incorporate computed tomography (CT) image data and digital subtraction angiography (DSA) image data to refine the heart model. A multi-channel recorder 60 is used to record ECG signals.

[0033] In this embodiment, the heart model formed by only the surface leads and the ablation catheter 10 contains a lot of noise. The three-dimensional mapping system 50 can also input computed tomography image data and subtraction angiography image data, and then combine them with algorithms to correct the coordinate values ​​of the images in the three-dimensional model to construct a more refined three-dimensional image, thereby making it easier for the operator to more accurately control the ablation catheter 10 to perform discharge ablation.

[0034] Please refer to the following: Figure 2 and Figure 3 , Figure 2 yes Figure 1 The diagram shows a partial structural representation of the ablation catheter 10 in one usage state. Figure 3 yes Figure 2 The diagram shows a cross-sectional view of the ablation catheter 10 cut along point AA.

[0035] In some embodiments, the ablation catheter 10 may include an outer tube 1, an inner tube 2, a first ablation component 101, a second ablation component 102, and an infusion catheter 7. Both the outer tube 1 and the inner tube 2 are hollow structures. The inner tube 2 is coaxially and movably inserted into the outer tube 1. The infusion catheter 7 is located inside the inner tube 2, and its distal end is located inside the first ablation component 101. The first ablation component 101 is located at the distal end of the inner tube 2. The first ablation component 101 can serve as a dot-matrix ablation structure of the ablation catheter 10, used for dot-matrix ablation of the target tissue area. The second ablation component 102 is located proximal to the first ablation component 101, and its proximal end is connected to the distal end of the outer tube 1. The second ablation component 102 can serve as a ring-shaped ablation structure of the ablation catheter 10, used for ring-shaped ablation of the target tissue area.

[0036] In some embodiments, the first ablation component 101 includes a conductive frame 3 and a plurality of second electrodes 6. The proximal end of the conductive frame 3 is mounted to the distal end of the inner tube 2, and the plurality of second electrodes 6 are fixed to the conductive frame 3. The conductive frame 3 may be made of a conductive material. The conductive frame 3 has a multi-faceted mesh structure. The second ablation component 102 includes a plurality of secondary rods 4 and a plurality of first electrodes 5. The distal end of each secondary rod 4 is fixed to the distal end of the inner tube 2, and the proximal end of each secondary rod 4 is fixed to the distal end of the outer tube 1. Each secondary rod 4 has an arc-shaped structure. In other embodiments, each secondary rod 4 may also be helical or other curved. The first electrodes 5 are disposed on the secondary rods 4, and the plurality of first electrodes 5 can form a ring-shaped electric field to perform ring-shaped ablation on the target tissue area.

[0037] In this embodiment, the first ablation component 101 of the ablation catheter 10 is used for point ablation of the target tissue area, and the second ablation component 102 is used for ring ablation of the target tissue area. Compared with existing ablation catheters, the ablation catheter 10 in this application integrates point ablation and ring ablation functions, enabling both point ablation and ring ablation to be achieved during the procedure. It can be used for ablation treatment of persistent atrial fibrillation, meeting the ablation needs of any location on the heart, while improving ablation efficiency.

[0038] In some embodiments, a plurality of auxiliary rods 4 are arranged around the inner tube 2, and the auxiliary rods 4 are spaced apart from each other. The auxiliary rods 4 are arranged symmetrically around the axial direction of the inner tube 2. The number of auxiliary rods 4 can be three, four, five, six, eight, or other suitable numbers. For example, the number of auxiliary rods 4 is six, and the six auxiliary rods 4 can be arranged at equal intervals to facilitate omnidirectional ablation of the target tissue. In other embodiments, the auxiliary rods 4 can also be arranged asymmetrically, and the auxiliary rods 4 can be arranged only at axial intervals around the inner tube 2; this application does not strictly limit this arrangement.

[0039] In some embodiments, the infusion catheter 7 may include multiple flushing ports 71, multiple helical channels 72, and a guidewire channel 73. The flushing ports 71 are connected to the helical channels 72 and are exposed relative to the distal end 74 of the infusion catheter 7. The helical channels 72 are located inside the infusion catheter 7. The flushing ports 71 of the infusion catheter 7 are located inside the conductive skeleton 3. The guidewire channel 73 is located inside the helical channels 72 and can be used to deliver a guidewire or install a traction wire (not shown in the figure). In other embodiments, the ablation catheter 10 may not have an infusion catheter 7, and this application does not strictly limit this.

[0040] In this embodiment, the infusion catheter 7 is connected to the pulse ablation device 30 and is used to infuse flushing fluid into the conductive skeleton 3 during ablation treatment. For example, the flushing fluid can be saline. The channel of the infusion catheter 7 is spiral-shaped, which can increase the cross-sectional flow rate of the flushing fluid at the flushing port 71, so that the flushing fluid is dispersed in multiple directions towards the interior of the conductive skeleton 3 to fully flush the conductive skeleton 3, thereby reducing blood stasis, avoiding thrombus formation, and preventing the cumulative thermal effect after multiple pulse ablations.

[0041] Please refer to the following: Figure 2 and Figure 4 , Figure 4 yes Figure 2 The diagram shows the structure of the second ablation component 102.

[0042] In some embodiments, multiple first electrodes 5 are fixed to multiple secondary rods 4 in a one-to-one correspondence. Each secondary rod 4 may include a supporting section 41 and a middle section 42. The supporting section 41 of the secondary rod 4 is disposed near the distal end of the secondary rod 4, and the first electrodes 5 may be disposed on the supporting section 41 of the secondary rod 4. The first electrodes 5 are disposed around the peripheral side of the supporting section 41 of the secondary rod 4. It should be noted that... Figure 4 The diagram only shows the positions of the bearing section 41 and the middle section 42 of one of the secondary rods 4. In this embodiment, the curvature of the bearing section 41 of the secondary rod 4 is relatively small during the bending process. When the first electrode 5 is fixed to the bearing section 41 of the secondary rod 4, deformation of the first electrode 5 can be avoided during the bending process of the secondary rod 4, thereby ensuring the stability of the first electrode 5.

[0043] In some other embodiments, the first electrode 5 may also be fixed to the middle part 42 of the secondary rod 4, or fixed between the bearing section 41 of the secondary rod 4 and the middle part 42 of the secondary rod 4. This application does not strictly limit this.

[0044] In some embodiments, the ablation catheter 10 may further include a first connector 43 and a second connector 44. The first connector 43 is fixedly connected to the distal ends of a plurality of auxiliary rods 4 and to the distal end of the inner tube 2. The second connector 44 is fixedly connected to the proximal ends of the plurality of auxiliary rods 4 and to the distal end of the outer tube 1. The plurality of auxiliary rods 4, the first connector 43, and the second connector 44 may be integrally formed.

[0045] In this embodiment, multiple auxiliary rods 4 are fixed by a first connector 43 and a second connector 44 and connected to the inner tube 2 and the outer tube 1. This makes the fixation between the multiple auxiliary rods 4 and the inner tube 2 and the outer tube 1 more stable, thereby ensuring that the multiple auxiliary rods 4 are not easily detached from the inner tube 2 and the outer tube 1 during bending.

[0046] In some embodiments, the multiple first electrodes 5 of the ablation catheter 10 can be divided into multiple first electrode groups 51. Multiple first electrode groups 51 are respectively fixed to multiple auxiliary rods 4; that is, multiple first electrodes 5 fixed to the same auxiliary rod 4 form a first electrode group 51, and each auxiliary rod 4 has one first electrode group 51. Each first electrode group 51 includes at least two first electrodes 5 spaced apart. Exemplarily, each first electrode group 51 may include three first electrodes 5; that is, three first electrodes 5 are fixed on each auxiliary rod 4. The first electrodes 5 may be annular electrodes, sheet electrodes, or rod electrodes; this application does not strictly limit this.

[0047] In some embodiments, the first electrode 5 can be used for ablation. The first electrodes 5 on the same sub-rod 4 have the same polarity, that is, all the first electrodes 5 in the same first electrode group 51 have the same polarity. In adjacent sub-rods 4, the first electrodes 5 are arranged one-to-one along the axial direction of the second ablation assembly 102 and the corresponding first electrodes 5 have opposite polarities. That is, the first electrodes 5 on the sub-rod 4 have opposite polarities to the corresponding first electrodes 5 on the adjacent sub-rod 4. Multiple first electrodes 5 form at least one ring in the circumferential direction of the second ablation assembly 102. In each ring, multiple first electrodes 5 form a ring-shaped electric field to perform ring-shaped ablation on the target tissue area.

[0048] For example, each first electrode group 51 may include three spaced-apart first electrodes 5. The three first electrodes 5, according to their different positions on the sub-rod 4, may be represented by first electrode 511, first electrode 512, and first electrode 513, respectively, and are spaced apart. For example, first electrode 511 may be fixed to the distal end of the bearing section 41 of the sub-rod 4, first electrode 513 may be fixed to the proximal end of the bearing section 41 of the sub-rod 4, and first electrode 512 may be fixed between first electrode 511 and first electrode 513. In adjacent sub-rods 4, the first electrodes 511, first electrode 512, and first electrode 513 in the two first electrode groups 51 are arranged correspondingly along the axial direction of the second ablation assembly 102.

[0049] In this process, the first electrodes 511, 512, and 513 of the same first electrode group 51 have the same polarity. The polarity of the first electrodes 511, 512, and 513 in one first electrode group 51 is opposite to that in an adjacent first electrode group 51. That is, the first electrodes 5 in adjacent first electrode groups 51 of the second ablation assembly 102 can be paired to form an electric field for circumferential ablation of the target tissue area.

[0050] In the circumferential direction of the second ablation component 102, all the first electrodes 511 can be arranged in a ring, and multiple first electrodes 511 in each ring form a ring-shaped electric field. All the first electrodes 512 can be arranged in a ring, and multiple first electrodes 512 in each ring form a ring-shaped electric field. All the first electrodes 513 can be arranged in a ring, and multiple first electrodes 513 in each ring form a ring-shaped electric field.

[0051] In this embodiment, all three first electrodes 5 of each first electrode group 51 can serve as ablation electrodes. The three first electrodes 5 of the same first electrode group 51 have the same polarity and can be discharged and ablated simultaneously. For example, the multiple first electrodes 5 of the ablation catheter 10 can be divided into six regions, with one region corresponding to one first electrode group 51. Each first electrode group 51 can be discharged individually. That is, some first electrode groups 51 can be discharged, while others do not participate in the discharge. The second ablation component 102 of the ablation catheter 10 can form a total of six discharge regions. When only some first electrode groups 51 participate in the discharge, the discharge area is reduced, thus forming a deeper ablation lesion. In addition, all the first electrodes 5 of the ablation catheter 10 can also be discharged simultaneously, forming a ring-shaped lesion, thereby enabling rapid ablation of areas such as the mitral isthmus, tricuspid isthmus, left atrial roof line, left atrial posterior wall line, fragmented potential area, and the large ring surrounding the pulmonary veins.

[0052] In some embodiments, the first electrode 5 is made of a conductive material; for example, the first electrode 5 may be made of a platinum-iridium alloy. The ablation catheter 10 also includes multiple wires (not shown in the figure), with each first electrode 5 individually connected to one wire. The first electrode 5 is electrically connected to the energy generator of the pulse ablation device 30 via the wires. The secondary rod 4 has a hollow structure, and the wires connecting the first electrodes 5 are all housed inside the secondary rod 4. At least the outer surface of the secondary rod 4 is made of an insulating material, and the first electrode 5 is insulated from the secondary rod 4.

[0053] Please refer to the following: Figure 2 , Figure 5 and Figure 6 , Figure 5 yes Figure 2 The diagram shown is a structural schematic of the first ablation component 101. Figure 6 yes Figure 5 The diagram shows a cross-sectional view of the first ablation component 101 cut along BB.

[0054] In some embodiments, the conductive framework 3 can be formed into a mesh structure by three-dimensionally cutting a semi-regular polyhedral lattice, such as by laser cutting. Exemplarily, the conductive framework 3 can be a continuous, monolithic structure. In other embodiments, the conductive framework 3 of the ablation catheter 10 may include multiple plates 31 connected to each other to form a mesh structure of the conductive framework 3; this application does not impose strict limitations on this.

[0055] In some embodiments, the conductive framework 3 may include a central grid 32 and multiple edge grid groups 33. Exemplarily, the number of edge grid groups 33 is five. Each edge grid group 33 includes at least one edge grid; for example, each edge grid group 33 may include a first edge grid 331 and a second edge grid 332. Two adjacent first edge grids 331 and the central grid 32 form a first grid structure 34, and a first grid node 341 is formed at the center of the first grid structure 34. The first edge grid 331, the second edge grid 332, and the first edge grid 331 of adjacent edge grid groups 33 form a second grid structure 35, and a second grid node 351 is formed at the center of the second grid structure 35. In this embodiment, the conductive framework 3 has a grid structure. Compared to the solid tip of a conventional ablation catheter, the conductive framework 3 of this application has a grid structure, which can prevent blood from accumulating at the conductive framework 3 during ablation to form a thrombus.

[0056] In some embodiments, the central grid 32, the first side grid 331, and the second side grid 332 of the conductive framework 3 are generally decagonal, that is, the conductive framework 3 in this embodiment may include 11 decagonal grids. The edges of the central grid 32, the first side grid 331, and the second side grid 332 are allowed to have a certain degree of curvature. In other embodiments, the shapes of the central grid 32, the first side grid 331, and the second side grid 332 may also be other shapes, such as pentagons, hexagons, circles, etc., and this application does not strictly limit them.

[0057] In some embodiments, multiple second electrodes 6 and conductive skeleton 3 are used to electrically connect the energy generator of the pulse ablation device 30, and both the multiple second electrodes 6 and conductive skeleton 3 can be used for ablation. The ablation conduit 10 also includes multiple wires (not shown in the figure). The first grid node 341 and the second grid node 351 of the conductive skeleton 3 are provided with mounting holes 36, which are used to install the second electrodes 6. The shape of the second electrodes 6 is adapted to the mounting holes 36. After the second electrodes 6 are connected to different wires one by one, they are installed in the mounting holes 36 of the conductive skeleton 3. The multiple wires connected to the second electrodes 6 are suspended inside the conductive skeleton 3 and connected to the pulse ablation device 30 along the inside of the inner tube 2. The conductive skeleton 3 can also be connected to the pulse ablation device 30 through wires. In other embodiments, the second electrodes 6 can also be fixed to the conductive skeleton 3 in other ways, and the conductive skeleton 3 may not be provided with mounting holes 36. For example, the second electrodes 6 can be fixed to the conductive skeleton 3 by snap-fitting, bonding, covering, attaching, embedding, or hot pressing, etc., and this application does not strictly limit this. The "inner" and "outer" orientations of the conductive frame 3 are relative descriptions, where the direction from the center of the conductive frame 3 towards the plate 31 is the "inner" to "outer" direction. For example, the center of the conductive frame 3 is located inside the plate 31, and the plate 31 is located outside the center of the conductive frame 3.

[0058] In some other embodiments, the first side grid 331, the second side grid 332 of the side grid group 33 and the second side grid 332 of the adjacent side grid group 33 form a third grid structure 37, and a third grid node 371 is also formed at the center of the third grid structure 37. The third grid node 371 is also provided with a mounting hole 36, which can also be used to install the second electrode 6, but this application does not strictly limit this.

[0059] In some embodiments, an insulating layer (not shown in the figure) is provided at the contact portion between the wire and the conductive frame 3, and an insulating layer is also provided at the portion of the wire that is suspended inside the conductive frame 3. The insulation between the multiple wires and the conductive frame 3 can be ensured by coating or wrapping an insulating material on the surface of each of the multiple wires.

[0060] In some embodiments, the second electrode 6 is made of a conductive material; for example, the material of the second electrode 6 can be a platinum-iridium alloy. The second electrode 6 may include a first part 61 and a second part 62, with the second part 62 connected to the first part 61 and located near the first part 61. The second part 62 of the second electrode 6 is mounted in the mounting hole 36 of the conductive frame 3, and the first part 61 of the second electrode 6 is located on the outside of the conductive frame 3. An insulating layer is provided at the contact portion between the second electrode 6 and the conductive frame 3. For example, insulation between the second electrode 6 and the conductive frame 3 can be ensured by coating or wrapping an insulating material on the inner surface of the first part 61 and the outer surface of the second part 62 of the second electrode 6, or by forming an insulating layer through vacuum deposition. In other embodiments, an insulating material can also be coated on the mounting hole 36 of the conductive frame 3 and the portion of the conductive frame 3 in contact with the second electrode 6 to achieve insulation between the conductive frame 3 and the multiple wires and the second electrode 6.

[0061] In this embodiment, an insulating layer is provided at the contact portion between the multiple wires and the conductive frame 3, and an insulating layer is provided at the contact portion between the second electrode 6 and the conductive frame 3, so that the conductive frame is insulated from the multiple wires and the second electrode 6, thereby enabling the conductive frame 3 and the second electrode 6 to discharge independently, avoiding the danger of short circuit between the second electrode 6 and the conductive frame 3 due to direct contact between the conductive frame 3 and the multiple wires and the second electrode 6, which could lead to tissue breakdown.

[0062] Please refer to the following: Figure 5 and Figure 7 , Figure 7 yes Figure 2 The diagram shows the structure of the ablation catheter 10 from another angle.

[0063] In some embodiments, the plurality of second electrodes 6 on the conductive frame 3 can be divided into a plurality of second electrode groups 63. The conductive frame 3 has a central axis, which is parallel to the direction from the proximal end to the distal end of the conductive frame 3. The plurality of second electrode groups 63 are arranged rotationally symmetrically around the central axis of the conductive frame 3, and each second electrode group 63 includes at least two second electrodes 6. Furthermore, all second electrodes 6 in the same second electrode group 63 have the same projection direction on a first plane, and the first plane is perpendicular to the central axis of the conductive frame 3. Figure 7 The plane in which it is located can be considered the first plane.

[0064] In this embodiment, the multiple second electrodes 6 of the ablation catheter 10 are divided into multiple second electrode groups 63, and the conductive framework 3 is also divided into multiple regions, with one region corresponding to one second electrode group 63. Each second electrode group 63 can be discharged individually for ablation, enabling the conductive framework 3 to achieve zoned ablation. For example, under the control of the pulse ablation device 30, the conduction between some of the multiple second electrode groups 63 and the energy generator can be selectively shut off, while at least one second electrode group 63 can be selected for discharge.

[0065] In some other embodiments, each of the multiple second electrodes 6 can be individually discharged for ablation. The conduction between some of the multiple second electrodes 6 and the energy generator can be selectively shut off, allowing at least one second electrode 6 to be discharged. This facilitates the operator in determining the adhesion between the second electrode 6 and the target tissue based on impedance during treatment, enabling targeted selection of the well-adhered second electrode group 63 for ablation, thereby reducing thermal effects at the treatment site and allowing control over the ablation area and depth.

[0066] In some embodiments, the number of second electrode groups 63 can be five. Each second electrode group 63 may include two second electrodes 6, which may be referred to as second electrode 631 and second electrode 632 respectively, depending on their positions on the conductive frame 3. Second electrodes 631 and 632 are spaced apart. Second electrode 631 is fixed to the first grid node 341 of the conductive frame 3, and second electrode 632 is fixed to the second grid node 351 of the conductive frame 3. Both second electrodes 631 and 632 of the second electrode group 63 can serve as ablation electrodes. When the ablation catheter 10 enters the patient's heart for treatment, due to the continuous beating of the heart, only a portion of the second electrodes 6 on the conductive frame 3 can adhere well to the atrial wall, while the portion of the second electrodes 6 in the opposite direction may float in the blood and not adhere to the atrial wall. Therefore, when a portion of the second electrode 6 on the conductive framework 3 is in good contact with the atrial wall, the portion of the second electrode 6 that is in good contact can be selected for discharge, and the conduction between the other second electrodes 6 and the energy generator can be shut off. By connecting the points into a line, ablation can be performed to form linear or band-shaped damage at the treatment site, thereby improving the ablation efficiency.

[0067] In this embodiment, the second electrode 6 on the conductive framework 3 performs zoned discharge, which avoids damage to tissues that are not intended to be ablated. The ablation energy can be targeted to the tissues that need to be ablated, avoiding the loss of pulse energy by the second electrode 6 in non-adhesive areas, increasing energy utilization, reducing energy dissipation in the blood, and avoiding discharge into the air, thus reducing unnecessary bubbles generated during blood electrolysis. During zoned discharge, it is not necessary to energize all the second electrodes 6, reducing the total current during ablation and reducing possible bodily stimulation. It also reduces the risk of short circuits or arcing caused by too many second electrodes 6, improving safety.

[0068] In some embodiments, the first electrode 5 on the secondary rod 4 can also be used for electrocardiogram (ECG) signal mapping of the target tissue area. The second electrode 6 on the conductive framework 3 can also be used for ECG signal mapping of the target tissue area. For example, during the movement of the ablation catheter 10, the first electrode 512 and the first electrode 513 on the secondary rod 4 and the second electrode 6 on the conductive framework 3 are most likely to form good contact with the myocardial tissue. Therefore, the first electrode 512 and the first electrode 513 on the secondary rod 4 and the second electrode 6 on the conductive framework 3 can be used as both ablation electrodes and mapping electrodes to perform three-dimensional mapping of the ECG signal of the target tissue area, thereby generating voltage maps and activation maps to locate focal and low-voltage lesions. However, the ablation discharge and mapping of the first electrode 512, the first electrode 513, and the second electrode 6 cannot be performed simultaneously. That is, the first electrode 512, the first electrode 513, and the second electrode 6 cannot release pulse current during mapping, and ECG signal mapping cannot be performed during the release of pulse current.

[0069] In some embodiments, the first electrode 512 and the first electrode 513 on the secondary rod 4, and the second electrode 6 on the conductive frame 3, can each individually form a mapping channel as a unipolar mapping electrode to map the patient's electrocardiogram (ECG) signal to generate a unipolar electrogram. In this embodiment, the unipolar mapping electrode can be used to determine whether the excitation passes through the mapping electrode, and ECG signal mapping can be achieved in 360° direction. The operator can select mapping channels in multiple directions according to the three-dimensional mapping results or actual ablation needs to map the ECG signal in a certain direction of the treatment site.

[0070] In some embodiments, the multiple first electrodes 512 and 513 on the secondary rod 4 and the multiple second electrodes 6 on the conductive frame 3 can each form a bipolar mapping channel as a bipolar mapping electrode to map the patient's electrocardiogram (ECG) signal to obtain a bipolar electrogram. For example, the first electrodes 512 and 513 located on the same secondary rod 4 can form a pair of bipolar mapping electrodes to obtain one bipolar electrogram; the five secondary rods 4 can form a total of six bipolar electrograms. The second electrodes 631 and 632 located on the same second electrode group 63 on the conductive frame 3 can form a pair of bipolar mapping electrodes to obtain one bipolar electrogram; all second electrode groups 63 can form five bipolar electrograms. Therefore, the entire ablation catheter 10 can form a total of 11 bipolar mapping channels, obtaining 11 bipolar electrograms. It should be noted that the bipolar mapping electrode consists of two mapping electrodes that do not distinguish between positive and negative poles; ECG signal mapping is performed through these two mapping electrodes.

[0071] In this embodiment, the bipolar mapping electrode formed by two second electrodes 6 can determine which second electrode 6 the activation is closer to, thereby improving mapping accuracy. By mapping the ECG signals on 11 different mapping channels of the ablation catheter 10, it is possible to adapt to ECG signal mapping under different contact conditions, so as to achieve comprehensive mapping of the treatment area, thereby facilitating the rapid location of the abnormal activation origin in the heart. The detected mapping signals are sent to the three-dimensional mapping system 50 to form a three-dimensional activation map, voltage map, etc. Under the three-dimensional mapping system 50, the ablation catheter 10 will reach the designated location more accurately for ablation treatment. Taking the activation map as an example, the colored dots on the generated activation map will move. Through this activation map, the earliest abnormal origin point and activation sequence can be found, thereby achieving precise location of the abnormal position, which is beneficial to improving the accuracy of ablation treatment.

[0072] In some other embodiments, the first electrode 513 on the secondary rod 4 can also be used as a mapping electrode for three-dimensional mapping of the electrocardiogram signal of the target tissue region. This application does not strictly limit this.

[0073] In some embodiments, the three-dimensional mapping system 50 of the ablation catheter 10 is obtained through electric field modeling combined with electrocardiogram mapping, CT images, and DSA images for auxiliary correction. Six electrode pads are attached to six sites on the patient's neck, thigh, chest, back, left arm, and right arm to form an electric field (not shown in the figure). In addition, an electrode pad is attached to the chest as a reference. The electrode pads are energized to form orthogonal electric fields in the x, y, and z three-dimensional directions. By measuring the electric field strength at the reference point, the attenuation of the electric field in different media is determined, and the positional distance corresponding to different field strengths is determined. When the ablation catheter 10 enters the orthogonal electric field, it forms a loop with the internal circuit of the three-dimensional mapping system 50 in the x, y, and z directions, and the different field strengths in the three directions are measured simultaneously. Through the attenuation equation of field strength with distance, the positional distance of a single second electrode 6 on the ablation catheter 10 in the orthogonal electric field can be obtained, thereby generating a three-dimensional model by sampling points. However, the image formed by electric field modeling alone still contains a lot of noise, and the system can be improved by inputting CT image data and DSA image data. The coordinate values ​​of the image are then corrected using algorithms to construct a more detailed three-dimensional image. Finally, after the ablation catheter 10 acquires the electrocardiogram (ECG) signal, the data is recorded, and the ECG signal is combined with the three-dimensional model to form a complete heart model.

[0074] In this embodiment, electric field modeling can be used to obtain the position and distance of the ablation catheter 10 in a three-dimensional electric field, allowing the operator to clearly see the position of the ablation catheter 10 through imaging equipment. By combining CT image data and DSA image data with algorithms, the image formed by electric field modeling is corrected to make the obtained three-dimensional image more refined and accurate. This allows the operator to better manipulate the ablation catheter 10 to quickly and accurately reach the lesion area for ablation treatment, thereby reducing the difficulty of operating and using the ablation catheter 10 and improving the operator's user experience.

[0075] Please see Figure 4 and Figure 8 , Figure 8 yes Figure 1 The diagram shows the structure of the ablation catheter 10 in two different application scenarios.

[0076] In some embodiments, the inner tube 2 may be made of a plastic with self-lubricating properties; for example, the inner tube 2 may be made of polytetrafluoroethylene (PTFE). The distal end of both the inner tube 2 and the distal end of the auxiliary rod 4 can move relative to the outer tube 1. The movement of the inner tube 2 relative to the outer tube 1 drives the movement of other components relative to the outer tube 1. In this embodiment, PTFE has excellent high-lubricity and non-stick properties, resulting in low frictional resistance between the inner tube 2 and the outer tube 1, making the movement of the inner tube 2 relative to the outer tube 1 easier.

[0077] In some embodiments, the second ablation component 102 has a contracted state and an expanded state, and the second ablation component 102 ablates the target tissue area in the expanded state. The secondary rod 4 has at least its outer surface made of an insulating material. Exemplarily, the secondary rod 4 can be made of an elastic and insulating material, for example, it can be made of thermoplastic polyurethane (TPU). The distal end of the secondary rod 4 is fixed to the distal end of the inner tube 2, and the proximal end of the secondary rod 4 is fixed to the distal end of the outer tube 1. The inner tube 2 can move proximally or distally relative to the outer tube 1 to switch the second ablation component 102 between the expanded and contracted states. The degree of bending of the multiple secondary rods 4 can be adjusted by adjusting the relative position of the inner tube 2 and the outer tube 1, thereby adjusting the outer diameter of the basket structure formed by the multiple secondary rods 4. During the movement of the inner tube 2 proximally relative to the outer tube 1, the inner tube 2 drives the distal end of the secondary rod 4 closer to the proximal end of the secondary rod 4, forming a movable portion between the distal end of the conductive skeleton 3 and the distal end of the outer tube 1. When the second ablation component 102 is in the expanded state, the middle portion 42 of the secondary rod 4 is far from the central axis of the inner tube 2, and the secondary rod 4 is arc-shaped. The central axis of the inner tube 2 is parallel to the direction from the proximal end to the distal end of the ablation catheter 10. As the distal end of the secondary rod 4 approaches the proximal end, the outer diameter of the maximum cross-section of the basket structure formed by the multiple secondary rods 4 gradually increases. The maximum cross-section of the basket structure is perpendicular to the axial direction of the inner tube 2.

[0078] In this embodiment, the secondary rod 4 is made of thermoplastic polyurethane elastomer. Thermoplastic polyurethane elastomer possesses high tensile strength, high tensile strength, high toughness, and aging resistance. Therefore, during the bending process of the secondary rod 4, wrinkles caused by changes in the curvature of the tubular skin can be avoided, which is beneficial for maintaining a stable connection between the first electrode 5 and the secondary rod 4. Furthermore, the distance by which the distal end of the secondary rod 4 moves towards its proximal end can be controlled as needed, so that the first electrode 5 on the secondary rod 4 can better adhere to the tissue at the treatment site, thereby achieving rapid pulmonary vein isolation.

[0079] In other embodiments, the secondary rod 4 may also be made of an elastic metal material, with an insulating material coated or covered on its surface. The first electrode 5 is fixed to the position on the secondary rod 4 where the insulating material is provided, and the insulating material insulates the secondary rod 4 from the first electrode 5. For example, the secondary rod 4 may be made of a nickel-titanium metal tube, a braided metal tube, etc., with an insulating layer coated or covered on its surface; this application does not impose strict limitations on this.

[0080] In some embodiments, when the second ablation component 102 is in a contracted state, the middle part 42 of the secondary rod 4 is close to the central axis of the inner tube 2, and the secondary rod 4 is linear, that is, multiple secondary rods 4 are parallel to the central axis of the ablation catheter 10, and the central axis of the ablation catheter 10 is parallel to the direction from the proximal end to the distal end of the ablation catheter 10. At this time, the basket structure formed by multiple secondary rods 4 is generally spindle-shaped. When the distal end of the inner tube 2 moves linearly along the central axis of the ablation catheter 10 towards the distal end of the outer tube 1, it drives the distal end of the auxiliary rod 4 to move linearly along the central axis of the ablation catheter 10 towards the proximal end of the auxiliary rod 4. When the distance from the distal end of the auxiliary rod 4 to the proximal end of the auxiliary rod 4 is the first stroke, the middle part 42 of the multiple auxiliary rods 4 moves away from the inner tube 2, and each auxiliary rod 4 is generally arc-shaped, so that the basket structure formed by the multiple auxiliary rods 4 is generally spindle-shaped. When the distance from the distal end of the auxiliary rod 4 to the proximal end of the auxiliary rod 4 is the second stroke (not shown in the figure), that is, when the movement stroke is the maximum, the distance between the distal end and the proximal end of the auxiliary rod 4 is the minimum, and the auxiliary rods 4 form a ring, so that the basket structure formed by the multiple auxiliary rods 4 is generally petal-shaped. This ring can be generally perpendicular to the longitudinal axis of the inner tube 2.

[0081] Please see Figure 2 , Figure 4 and Figure 9 , Figure 9 yes Figure 1 The diagram shows a partial structural representation of the ablation catheter 10 in another application scenario.

[0082] In some embodiments, when the distal end of the inner tube 2 moves spirally towards the distal end of the outer tube 1 along the central axis of the ablation catheter 10, it can drive the distal end of the auxiliary rod 4 to move spirally towards the proximal end of the auxiliary rod 4 along the central axis of the ablation catheter 10. The auxiliary rod 4 is spiral-shaped during bending, meaning that each auxiliary rod 4 has a different twist angle at different positions from its proximal end. Specifically, the spiral angle of the middle portion 42 of the auxiliary rod 4 is greater than the spiral angle of the proximal or distal end of the auxiliary rod 4, and the spiral angle decreases from the middle portion 42 towards both ends. When the distance from the distal end of the auxiliary rod 4 to its proximal end is the first stroke, the middle portions 42 of the multiple auxiliary rods 4 move away from the inner tube 2, and the multiple auxiliary rods 4 are generally spiral-shaped, forming a basket structure that is generally spindle-shaped. When the distance the distal end of secondary rod 4 moves towards its proximal end reaches the second stroke, i.e., when the stroke is at its maximum, the distance between the distal and proximal ends of secondary rod 4 is minimum, and the basket structure formed by multiple secondary rods 4 is roughly petal-shaped. It should be noted that... Figure 9 This is a schematic diagram of the structure after the ablation catheter 10 retracts the first ablation component 101 into the inner tube 2.

[0083] In this embodiment, the distal end of the secondary rod 4 moves toward the proximal end of the secondary rod 4 in a spiral motion, that is, the secondary rod 4 is spiral-shaped during bending, which makes the secondary rod 4 more compliant. The curvature of the secondary rod 4 is small, which makes it easier for the basket structure formed by multiple secondary rods 4 to closely adhere to the tissue of the treatment site. At the same time, it makes the first electrode 5 located in the bearing section 41 or the middle part 42 of the secondary rod 4 as close to the same plane as possible, so as to better adhere to the tissue of the treatment site, thereby helping to improve the efficiency of pulmonary vein isolation.

[0084] Please refer to the following: Figure 3 and Figure 10 , Figure 10 This is a schematic diagram of the structure of an ablation catheter 10 provided in this application under different usage states in some embodiments.

[0085] In some embodiments, the outer tube 1 and the inner tube 2 may be made of an elastic material. The infusion catheter 7 may also be made of an elastic material; for example, the infusion catheter 7 may be made of polyether block amide (PEBA). In other embodiments, the proximal end of the infusion catheter 7 may be made of an elastic material, and the body of the infusion catheter 7 may be made of a metallic material. The portion of the infusion catheter 7 other than its proximal end constitutes the body of the infusion catheter 7.

[0086] In this embodiment, both the outer tube 1 and the inner tube 2 are made of elastic material, and the infusion catheter 7 is also made of elastic material, or the proximal end of the infusion catheter 7 is made of elastic material. Therefore, the outer tube 1, the inner tube 2, and the proximal end of the infusion catheter 7 can all be bent. The outer tube 1, the inner tube 2, and the proximal end of the infusion catheter 7 can be bent away from the central axis of the ablation catheter 10 under the action of the inner traction mechanism (not shown in the figure) of the outer tube 1.

[0087] In some embodiments, the bending angle θ of the outer tube 1 towards the side away from the central axis of the ablation catheter 10 satisfies: 0°≤θ≤90°, and the outer tube 1 can bend to the left or to the right. In other embodiments, the bending angle θ of the outer tube 1 towards the side away from the central axis of the ablation catheter 10 is also within other ranges, which are not strictly limited in this application. In this embodiment, the degree of bending of the outer tube 1 can be adjusted according to actual needs. The bending direction of the outer tube 1 can also be controlled. The outer tube 1 can be bent in multiple directions in three-dimensional space, and can be bent according to different structures of the patient's heart to select appropriate treatment sites and treatment angles, so that the first ablation component 101 and the second ablation component 102 of the ablation catheter 10 can better fit against the treatment site, thereby meeting the ablation and mapping needs of any location on the heart.

[0088] Please refer to the following: Figure 2 and Figure 3In some embodiments, the first ablation component 101 has a contracted state and an expanded state. In the expanded state, the first ablation component 101 ablates the target tissue area. The conductive skeleton 3 can be made of nickel-titanium material. For example, the conductive skeleton 3 can be laser-cut and then shaped using a shaping fixture. The nickel-titanium conductive skeleton 3 is elastic and flexible, and is a shape-memory deformable structure. Therefore, the conductive skeleton 3 can switch between a contracted state and an expanded state. When the conductive skeleton 3 is in a contracted state, the multiple plates 31 of the conductive skeleton 3 contract inwards, and the conductive skeleton 3 has a small volume, which can be accommodated inside the inner tube 2. When the conductive skeleton 3 is in an expanded state, the multiple plates 31 of the conductive skeleton 3 expand outwards, and the conductive skeleton 3 is generally spherical. In this embodiment, the conductive skeleton 3 is a deformable structure, allowing it to fit well against the tissue of the treatment site, facilitating the discharge ablation by the first ablation component 101.

[0089] In some embodiments, the infusion catheter 7 is slidably mounted inside the inner tube 2, and the conductive skeleton 3 can be fixed to the side of the infusion catheter 7 near the distal end of the inner tube 2. The ablation catheter 10 also includes a handle (not shown in the figure), and a traction mechanism disposed inside the handle can drive the infusion catheter 7 to move relative to the inner tube 2, thereby allowing the infusion catheter 7 to drive the conductive skeleton 3 to move relative to the inner tube 2, realizing the extension and retraction of the conductive skeleton 3 relative to the inner tube 2. During the movement of the distal end of the infusion catheter 7 towards the distal end of the inner tube 2, the infusion catheter 7 drives the conductive skeleton 3 to move towards the distal end of the inner tube 2. When the conductive skeleton 3 is in the contracted state, the volume of the conductive skeleton 3 can be very small, so that it can be retracted to the inside of the inner tube 2, so that the conductive skeleton 3 is located inside the inner tube 2, thereby the first ablation component 101 is in the contracted state. When the conductive skeleton 3 extends from the inside of the inner tube 2, the conductive skeleton 3 can change to the expanded state, and the conductive skeleton 3 is located at the distal end of the inner tube 2, thereby the first ablation component 101 is in the expanded state.

[0090] In this embodiment, when the ablation catheter 10 uses only the second ablation component 102, both the conductive frame 3 and the infusion catheter 7 can be housed inside the inner tube 2, meaning the first ablation component 101 is in a contracted state, thus facilitating the second ablation component 102 to discharge independently. Furthermore, when the ablation catheter 10 uses the second ablation component 102, the first ablation component 101 and the infusion catheter 7 cannot be housed inside the inner tube 2. That is, the conductive frame 3 remains at the distal end of the multiple auxiliary rods 4, and the first ablation component 101 remains in an expanded state. At this time, the conductive frame 3 can be used to position the ablation catheter 10, and the pulse ablation device 30 can control only the second ablation component 102 of the ablation catheter 10 to adhere to the treatment site for ablation.

[0091] In some other embodiments, the conductive skeleton 3 can be fixed to a fixing ring (not shown in the figure). The fixing ring is slidably installed on the inner side of the inner tube 2. The pulling mechanism can drive the fixing ring to move relative to the inner tube 2, so that the fixing ring can drive the conductive skeleton 3 to move relative to the inner tube 2, thereby realizing the extension and retraction of the conductive skeleton 3 relative to the inner tube 2. This application does not make strict limitations on this.

[0092] In some embodiments, the ablation catheter 10 further includes a reference electrode 8, which is located on the proximal side of the conductive frame 3 when the conductive frame 3 is in an expanded state. The proximal side is the side closest to the proximal end of the ablation catheter 10. The reference electrode 8 is used for electrocardiogram signal mapping to obtain a reference potential. Exemplarily, the reference electrode 8 can be fixed to the first connector 43 of the auxiliary rod 4. In other embodiments, the reference electrode 8 can also be fixed to the distal end of the inner tube 2; or when the first connector 43 is made of a conductive material, the first connector 43 can be used as the reference electrode 8 of the ablation catheter 10, which is not strictly limited in this application. The reference electrode 8 can be made of a conductive material; exemplarily, the material of the reference electrode 8 can be a platinum-iridium alloy. The lead wire of the reference electrode 8 is installed in the body of the inner tube 2 and connected to the pulse ablation device 30.

[0093] In this embodiment, the multiple second electrodes 6 fixed to the conductive frame 3 and the multiple first electrodes 512 and 513 located on the auxiliary rod 4 can all be well attached to the atrial wall of the patient to serve as mapping electrodes for mapping the patient's electrocardiogram (ECG) signal. Although the reference electrode 8 is not attached to the atrial wall, it can also be used to map the patient's ECG signal. The ablation system 100 can obtain a more accurate electrical signal based on the difference between the electrical signal mapped by the reference electrode 8 and the electrical signal of the second electrode 6 when the conductive frame 3 is discharged as a whole, or the difference between the electrical signal mapped by the reference electrode 8 and the electrical signal when the multiple first electrodes 512 and 513 on the auxiliary rod 4 are discharged, so as to achieve accurate mapping of the patient's ECG signal. In addition, the reference electrode 8 can also serve as a reference for the three-dimensional mapping image of the ablation catheter 10. Combined with digital subtraction angiography, the position of the ablation catheter 10 can be visualized in the three-dimensional mapping image.

[0094] Please refer to the following: Figure 2 , Figure 7 and Figure 8 In some embodiments, the pulse ablation device 30 can be used to control the discharge state of the ablation catheter 10. When the ablation catheter 10 is in the spot ablation mode, the ablation catheter 10 only needs to use the first ablation component 101 to ablate the treatment site, therefore it is necessary to control the first ablation component 101 to be in an expanded state. That is, the multiple auxiliary rods 4 can be arc-shaped, or the multiple auxiliary rods 4 can also be linear. The first ablation component 101 has multiple ablation modes.

[0095] In some embodiments, the conductive framework 3 is conductive and capable of forming a spherical electric field to perform point ablation on the target tissue region. Specifically, the conductive framework 3 is paired with at least one first electrode 5 to form a spherical electric field, or the conductive framework 3 is paired with an external negative electrode plate to form a spherical electric field for point ablation of the target tissue region. The conductive framework 3 can discharge independently. For example, the conductive framework 3 can be paired with at least one first electrode 512 and / or at least one first electrode 513 on the secondary rod 4. For instance, the conductive framework 3 can be set as the positive electrode alone, with at least one first electrode 512 and / or at least one first electrode 513 on the secondary rod 4 serving as the negative electrode, and the first electrode 511 remaining idle. A positive and negative electrode circuit is formed between the conductive framework 3 and at least one first electrode 512 and / or at least one first electrode 513. The reason for selecting the first electrode 512 and / or the first electrode 513 on the secondary rod 4 to be paired with the conductive skeleton 3 is that the first electrode 512 and the first electrode 513 on the secondary rod 4 are most likely to form a good fit with the myocardial tissue, which is more conducive to the discharge ablation of the first ablation component 101.

[0096] The conductive framework 3 is paired with at least one second electrode 6 to form a spherical electric field for point ablation of the target tissue area. For example, one of the conductive framework 3 and the at least one second electrode 6 is designated as the positive electrode, and the other as the negative electrode, forming a positive-negative electrode circuit between the at least one second electrode 6 and the conductive framework 3.

[0097] The second electrode 6 can discharge independently, and at least one second electrode 6 is paired with at least one first electrode 5 to form a local electric field for local ablation of the target tissue area. For example, at least one second electrode 6 can be paired with at least one first electrode 512 and / or at least one first electrode 513 on the secondary rod 4. For instance, at least one second electrode 6 can be set as the positive electrode, and at least one first electrode 512 and / or at least one first electrode 513 on the secondary rod 4 can be used as the negative electrode, while the first electrodes 511 are left idle. A positive and negative electrode circuit is formed between at least one second electrode 6 and at least one first electrode 512 and / or at least one first electrode 513.

[0098] The conductive framework 3 can discharge together with at least one second electrode group 63. The conductive framework 3, at least one second electrode group 63, and at least one first electrode 5 are paired to form a local electric field for local ablation of the target tissue area. For example, the second electrodes 6 of the conductive framework 3 and at least one second electrode group 63 are used as positive electrodes, and at least one first electrode 512 and / or at least one first electrode 513 located on multiple auxiliary rods 4 are used as negative electrodes, while the first electrodes 511 are idle. A positive and negative electrode circuit is formed between the conductive framework 3, the second electrodes 6 of at least one second electrode group 63, and at least one first electrode 512 and / or at least one first electrode 513. The positive and negative electrodes are connected to the pulse ablation device 30. When the pulse ablation device 30 emits pulse energy, a pulse electric field is formed between the positive and negative electrodes, causing irreversible electroporation damage to the target tissue at the treatment site. Under the pulse electric field, the first ablation component 101 can form a point-like ablation zone.

[0099] In this embodiment, the conductive frame 3 serves as the positive electrode, and at least one first electrode 5 serves as the negative electrode; or, at least one second electrode 6 is paired with the conductive frame 3 to form a positive and negative electrode circuit; or, at least one second electrode 6 serves as the positive electrode, and at least one first electrode 5 serves as the negative electrode; or, the conductive frame 3 and at least one second electrode group 63 serve as the positive electrode, and at least one first electrode 5 serves as the negative electrode. Compared with the prior art, the ablation catheter 10 in this application does not require an additional negative electrode plate for attaching to the patient's back. Ablation is performed using the positive and negative electrodes of the ablation catheter 10 itself, forming bipolar pulse ablation. On the one hand, the bipolar pulse ablation method eliminates the need for an external negative electrode plate, thereby reducing muscle stimulation and helping to improve the ablation effect. On the other hand, the current generated by the discharge of the conductive frame 3, or the current generated by the discharge of the conductive frame 3 and multiple second electrodes 6, is directly transmitted through the patient tissue to the second first electrode 512 and the third first electrode 513, and finally returns to the ablation system 100 through a wire to form a circuit. The distance between the positive and negative electrodes is shorter; therefore, the ablation catheter 10 consumes less energy and has a faster ablation speed during ablation.

[0100] In some other embodiments, the conductive frame 3 can be paired with the external negative electrode plate, and the conductive frame 3 can be set as the positive electrode alone. A positive and negative electrode circuit is formed between the conductive frame 3 and the negative electrode plate. This application does not impose strict limitations on this.

[0101] In some embodiments, the pulse ablation device 30 can control one or more second electrode groups 63 on the conductive frame 3 to perform zoned discharge. For example, one second electrode group 63 on the conductive frame 3 can discharge independently, meaning the second electrode 6 in one second electrode group 63 discharges simultaneously, while the second electrodes 6 in other second electrode groups 63 and the conductive frame 3 do not participate in the discharge. For example, multiple second electrode groups 63 in a certain area of ​​the conductive frame 3 can discharge simultaneously, while the second electrode groups 63 in other areas and the conductive frame 3 do not participate in the discharge. When the second electrode groups 63 on the conductive frame 3 perform zoned discharge, the second ablation component 102 can be in a contracted state, meaning the multiple auxiliary rods 4 need to be adjusted into a spindle shape. Adjusting the multiple auxiliary rods 4 into a spindle shape can reduce the size, allowing the ablation catheter 10 to pass through the blood vessel more easily. The second electrode 6 of the discharging second electrode group 63 is set as the positive electrode, and at least one first electrode 5 is set as the negative electrode. For example, when one or more second electrode groups 63 in a certain region discharge, all second electrodes 6 in the discharging second electrode group 63 are set as positive electrodes, and at least one first electrode 512 and / or at least one first electrode 513 located on multiple auxiliary rods 4 are set as negative electrodes, while the first electrodes 511 are all idle. A local electric field is formed between the discharging second electrode group 63 and at least one first electrode 512 and / or at least one first electrode 513, forming a point-like ablation zone.

[0102] In this embodiment, when the conductive framework 3 discharges for spot ablation, if each point needs to achieve a very deep ablation depth according to actual clinical needs, then when performing spot-and-line ablation in the mitral valve isthmus, the His bundle is easily damaged, leading to atrioventricular block. However, when the conductive framework 3 does not discharge, and the second electrode group 63 on the conductive framework 3 performs zoned discharge, under the same ablation parameters, the depth of ablation damage can be increased due to the reduced discharge area during zoned discharge. Simultaneously, since the discharge direction of the second electrode group 63 on the conductive framework 3 is selectable during zoned discharge, the His bundle can be avoided, preventing His bundle damage and thus preventing adverse events.

[0103] In some embodiments, when the second ablation component 102 performs discharge ablation, the two adjacent first electrode groups 51 on two adjacent secondary rods 4 can be set as positive and negative electrodes, respectively. That is, the six first electrode groups 51 on the six secondary rods 4 are set as three positive and three negative electrodes, with the positive and negative electrodes alternating. In this embodiment, an electric field is formed between the two adjacent first electrode groups 51 on every two adjacent secondary rods 4, which can form electric fields in six directions. This is beneficial for creating large-area damage and can quickly complete pulmonary vein isolation.

[0104] In some embodiments, each secondary rod 4 of the second ablation component 102 can discharge independently. When a certain tissue area of ​​the patient requires ablation by the second ablation component 102, the second ablation component 102 needs to be in an expanded state, that is, the curvature of the secondary rod 4 is adjusted so that the secondary rod 4 is in contact with the atrial wall to improve the contact of the second ablation component 102. The first electrode group 51 on the portion of the secondary rod 4 with good contact with the atrial wall can be selected for discharge, and the conduction between the first electrode 5 on the other secondary rod 4 and the energy generator can be closed. For example, the first electrode group 51 on two adjacent secondary rods 4 can be selected for discharge, with the first electrode group 51 on one secondary rod 4 set as the positive electrode and the first electrode group 51 on the other secondary rod 4 set as the negative electrode, and the first electrode group 51 on the other secondary rod 4 does not participate in the discharge, only forming an electric field between the two adjacent secondary rods 4, thereby forming a linear lesion area. Alternatively, a portion of the first electrode group 51 on the secondary rod 4 can be selected for discharge, and the first electrode group 51 on the other secondary rod 4 does not participate in the discharge. In one of the sub-bars 4 that participate in the discharge, at least one first electrode group 51 on the sub-bar 4 is set as a positive electrode, at least one first electrode group 51 on the sub-bar 4 is set as a negative electrode, and the first electrode group 51 on the remaining sub-bars 4 can be set as either a positive electrode or a negative electrode. At the same time, the positive and negative electrodes of the first electrode group 51 on the sub-bars 4 can be adjusted according to the structure of the target tissue, and an electric field is formed between the sub-bars 4 that participate in the discharge.

[0105] In this embodiment, selectively discharging a portion of the secondary rods 4 avoids damage to unintended tissues caused by multiple first electrode groups 51. The ablation energy can be targeted to the tissue requiring ablation, preventing the first electrode groups 51 in non-adhesive areas from losing pulse energy, increasing energy utilization, reducing energy dissipation in the blood, and avoiding discharge into empty space, thus reducing unnecessary bubbles generated during blood electrolysis. Furthermore, with the same ablation parameters, the reduced discharge area when only some secondary rods 4 discharge allows for deeper ablation damage. Discharging only a portion of the secondary rods 4 in sections eliminates the need to energize all first electrode groups 51, reducing the total current during ablation and minimizing potential bodily stimulation. It also reduces the risk of short circuits or arcing caused by an excessive number of first electrode groups 51, improving safety.

[0106] In some embodiments, when only the first ablation component 101 is needed for the ablation catheter 10, the outer tube 1, inner tube 2, and second ablation component 102 can all be housed inside the ablation sheath (not shown in the figure). Alternatively, the multiple auxiliary rods 4 can be adjusted to a linear state, so that the second ablation component 102 is in a contracted state, with only the conductive skeleton 3 and the second electrode 6 located at the distal end of the ablation sheath. In this case, the conductive skeleton 3 is in an expanded state, that is, the first ablation component 101 is in an expanded state, so that the first ablation component 101 can form a good fit with the tissue at the treatment site, allowing the ablation catheter 10 to perform point ablation independently. When only the second ablation component 102 of the ablation catheter 10 is needed, the conductive skeleton 3 and the infusion catheter 7 can be retracted into the inner tube 2 by operating the traction mechanism through the handle, so that the first ablation component 101 is in a contracted state. At the same time, the distal end of the inner tube 2 can be controlled to move towards the outer tube 1, causing the auxiliary rod 4 to be in different bending states, so that the second ablation component 102 is in an expanded state, so that the first electrode 5 on the auxiliary rod 4 can form a good fit with the tissue of the treatment site, which is more conducive to the first electrode 5 to perform discharge ablation, thereby improving the ablation efficiency.

[0107] In this embodiment, when only the first ablation component 101 is used in the ablation catheter 10, it can be controlled so that only the first ablation component 101 is in contact with the tissue at the treatment site, so as to better achieve point ablation. When only the second ablation component 102 of the ablation catheter 10 is used, it can be controlled so that only the second ablation component 102 is in contact with the tissue at the treatment site, so as to better achieve ring ablation. Therefore, in this embodiment, the ablation catheter 10 can switch between the individual point ablation function and the individual ring ablation function by controlling the extension and retraction of the second ablation component 102 relative to the ablation sheath, and by controlling the extension and retraction of the conductive skeleton 3 relative to the inner tube 2, so as to avoid mutual interference between the first ablation component 101 and the second ablation component 102.

[0108] In some other embodiments, when only the first ablation component 101 is needed for the ablation catheter 10, the multiple auxiliary rods 4 can be adjusted to an arc shape, so that the second ablation component 102 is in an expanded state. When only the second ablation component 102 of the ablation catheter 10 is needed, the first ablation component 101 can also be adjusted to an expanded state; this application does not impose strict limitations on this.

[0109] In some applications, the ablation catheter 10 in this embodiment can be used to treat persistent atrial fibrillation. For patients with persistent atrial fibrillation due to multiple triggering factors, instruments capable of both pulmonary vein isolation and dot-marking isolation must be used during the procedure. This embodiment provides a combined multifunctional dot-marking pulse ablation catheter 10 with rapid pulmonary vein isolation capabilities, which can exclude pulmonary vein triggering factors, allowing the operator to focus more on addressing other triggering factors such as ganglion plexuses, multi-wavelet (or trochanteric) triggers, non-pulmonary vein triggers, autonomic nerves, and the atrial fibrillation matrix.

[0110] Please refer to the reference again. Figure 1 , Figure 2 and Figure 7 In this embodiment, the treatment method of the ablation catheter 10 can be as follows: First, preoperative preparation, including equipment wiring, patient boarding, disinfection, etc. Then, the patient's femoral vein is punctured. After the femoral vein puncture is completed, the patient's atrial septum is punctured. After the atrial septum puncture is completed, the ablation sheath of the pulse ablation device can be used. When the ablation sheath enters the left atrium, the ablation catheter 10 is inserted into the ablation sheath and enters the left atrium through the lumen of the ablation sheath. After the ablation catheter 10 reaches the left atrium, three-dimensional mapping is performed first. After the mapping is completed, the pulmonary vein is isolated through the second ablation component 102. After the pulmonary vein is isolated, the mitral isthmus line and the left atrial roof line are isolated through the first ablation component 101, and abnormal activation points or lesion areas are ablated and removed. After the left atrial ablation is completed, the ablation sheath and ablation catheter 10 are withdrawn from the left atrium and reach the right atrium. The tricuspid isthmus is isolated through the second ablation component 102. After isolation was completed, three-dimensional mapping was performed again to verify the electrical signal transmission. Once the electrical signal transmission verification was successful, the surgery was completed.

[0111] Please refer to the following: Figure 11 and Figure 12 , Figure 11 This is a partial structural schematic diagram of an ablation catheter 10 provided in this application in some other embodiments. Figure 12 yes Figure 11 The diagram shows a cross-sectional view of the ablation catheter 10 cut along CC.

[0112] In some embodiments of this application, the ablation catheter 10 may include an outer tube 1, an inner tube 2, a first ablation component 101, a second ablation component 102, an infusion catheter 7, and a reference electrode 8. The first ablation component 101 may include a conductive frame 3 and a plurality of second electrodes 6, and the second ablation component 102 may include a plurality of auxiliary rods 4 and a plurality of first electrodes 5. The structures of the outer tube 1, inner tube 2, conductive frame 3, auxiliary rods 4, first electrodes 5, second electrodes 6, infusion catheter 7, and reference electrode 8 can be referred to the relevant descriptions in the preceding embodiments, and will not be repeated here.

[0113] In some embodiments, the proximal end of the conductive skeleton 3 can be fixed to the distal end of the inner tube 2. The infusion catheter 7 is located inside the inner tube 2, the conductive skeleton 3 is located at the distal end of the inner tube 2, and the reference electrode 8 is located at the proximal end of the conductive skeleton 3. When only the first ablation component 101 is used in the ablation catheter 10, the outer tube 1, the inner tube 2, and the second ablation component 102 can all be housed inside the ablation sheath (not shown in the figure), with only the conductive skeleton 3 and the second electrode 6 located at the distal end of the ablation sheath. At this time, the conductive skeleton 3 is in an expanded state, thereby the first ablation component 101 is in an expanded state, and the first ablation component 101 can form a good fit with the tissue at the treatment site, so that the ablation catheter 10 can perform spot ablation independently. When only the second ablation component 102 is needed for the ablation catheter 10, the entire ablation catheter 10 can be pushed out of the ablation sheath. The pulse ablation device 30 can control only the second ablation component 102 to discharge, while the first ablation component 101 formed by the conductive skeleton 3 does not discharge, so as to achieve ring ablation of the pulmonary vein and other parts.

[0114] In this embodiment, since the proximal end of the conductive skeleton 3 is directly fixed to the distal end of the inner tube 2, even when the conductive skeleton 3 is in a compressed state, it cannot be contained within the inner side of the inner tube 2. Therefore, when the second ablation component 102 performs ablation, the conductive skeleton 3 remains located at the distal end of the auxiliary rod 4. However, the pulse ablation device 30 can still control the discharge of only the first ablation component 101 of the ablation catheter 10 and only the second ablation component 102, so that the discharge of the first ablation component 101 and the discharge of the second ablation component 102 do not interfere with each other, and can perform spot ablation and annular ablation respectively.

[0115] Please see Figure 13 , Figure 13 This is a partial structural schematic diagram of an ablation catheter 10 provided in this application in some embodiments.

[0116] In some embodiments of this application, the ablation catheter 10 may include an outer tube 1, an inner tube 2, a first ablation component 101, a second ablation component 102, an infusion catheter 7, and a reference electrode 8. The first ablation component 101 may include a conductive framework 3 and multiple second electrodes 6, and the second ablation component 102 may include multiple auxiliary rods 4 and multiple first electrodes 5. The structures of the outer tube 1, inner tube 2, conductive framework 3, second electrodes 6, infusion catheter 7, and reference electrode 8 can be referred to the relevant descriptions in the previous embodiments, and will not be repeated here. In this embodiment, only the structure of the auxiliary rods 4 differs from the embodiments described above.

[0117] In some embodiments, the auxiliary rod 4 is made of a conductive material. Exemplarily, the auxiliary rod 4 can be made of an elastic metal material such as nickel-titanium alloy; this application does not strictly limit this. The ablation catheter 10 also includes multiple wires (not shown in the figure), each wire corresponding to one of the auxiliary rods 4, meaning that all auxiliary rods 4 are connected to the pulse ablation device 30 via wires. The multiple auxiliary rods 4 can be used for electrical ablation. The multiple auxiliary rods 4 are arranged around the inner tube 2, and are spaced apart from each other. The number of auxiliary rods 4 can be three, four, six, eight, or other suitable numbers. Exemplarily, there are six auxiliary rods 4, arranged at equal intervals, to facilitate comprehensive ablation of the pulmonary veins.

[0118] In this embodiment, multiple auxiliary rods 4 can all discharge, including a second ablation assembly 102 with multiple auxiliary rods 4, enabling annular ablation of the ablation catheter 10. Each auxiliary rod 4 of the ablation catheter 10 can discharge individually. The second ablation assembly 102 of the ablation catheter 10 can form a total of six discharge regions. Furthermore, all auxiliary rods 4 of the ablation catheter 10 can also discharge simultaneously, forming annular damage, thereby enabling rapid ablation of areas such as the mitral isthmus, tricuspid isthmus, left atrial roof line, left atrial posterior wall line, fragmented potential area, and the large ring surrounding the pulmonary veins.

[0119] In other embodiments, the secondary rod 4 may be made of a conductive material, with an insulating material coated or covered on a portion of the conductive material surface. For example, the secondary rod 4 may be made of an elastic metal material such as a nickel-titanium alloy, with an insulating material coated or covered on the metal material surface. The portion of the secondary rod 4 without an insulating material coating or covering is used for discharge; this application does not impose strict limitations on this.

[0120] Please see Figure 13 and Figure 14 , Figure 14 yes Figure 13 The diagram shows the structure of the ablation catheter 10 from another angle.

[0121] In some embodiments, when the secondary rod 4 is used as a conductor for discharge ablation, it may not participate in the mapping of the patient's electrocardiogram (ECG) signal. Each of the multiple second electrodes 6 on the conductive framework 3 of the ablation catheter 10 can individually form a mapping channel to map the patient's ECG signal and obtain a unipolar electrogram. Alternatively, pairs of the multiple second electrodes 6 on the conductive framework 3 can form bipolar mapping channels. For example, two second electrodes 6 located in the same second electrode group 63 form a pair of bipolar mapping electrodes to map the patient's ECG signal and obtain a bipolar electrogram. Furthermore, the reference electrode 8 can serve as an auxiliary mapping electrode to map the patient's ECG signal. In this embodiment, the multiple second electrodes 6 on the conductive framework 3 are evenly distributed, enabling ECG signal mapping in a 360° direction. Therefore, the ablation catheter 10 can still achieve good mapping results.

[0122] In some embodiments, the pulse ablation device 30 can be used to control the discharge state of the ablation catheter 10. When the ablation catheter 10 is in the spot ablation mode, only the first ablation component 101 needs to be used. The first ablation component 101 needs to be in an expanded state, and the multiple auxiliary rods 4 can be adjusted into a shuttle shape so that the second ablation component 102 is in a contracted state. Only the first ablation component 101 is in contact with the treatment site to ablate the area to be treated. The conductive frame 3 is conductive and can form a spherical electric field to perform spot ablation on the target tissue area. Exemplarily, the conductive frame 3 and / or at least one second electrode 6 are paired with the auxiliary rods 4 and electrically connected to the energy generator to deliver the pulse ablation energy output by the energy generator to the target tissue area. The conductive frame 3 can discharge independently. Exemplarily, the conductive frame 3 is paired with at least one auxiliary rod 4 to form a spherical electric field. For example, the conductive frame 3 can be set as the positive electrode alone, and at least one secondary rod 4 can be used as the negative electrode, forming a positive and negative electrode circuit between the conductive frame 3 and at least one secondary rod 4.

[0123] The conductive framework 3 can discharge together with at least one second electrode 6. The conductive framework 3, at least one second electrode 6, and at least one auxiliary rod 4 are paired to form a local electric field for local ablation of the target tissue area. For example, the conductive framework 3 and at least one second electrode 6 are both used as positive electrodes, and at least one auxiliary rod 4 is used as a negative electrode. A positive and negative electrode circuit is formed between the conductive framework 3, at least one second electrode 6, and at least one auxiliary rod 4.

[0124] The second electrode 6 can discharge independently, and at least one second electrode 6 and at least one auxiliary rod 4 are paired to form a local electric field for local ablation of the target tissue area. For example, at least one second electrode 6 can be set as the positive electrode, and at least one auxiliary rod 4 can be used as the negative electrode, forming a positive-negative electrode circuit between the at least one second electrode 6 and the at least one auxiliary rod 4.

[0125] Furthermore, the conductive framework 3 is paired with at least one second electrode 6 to form a spherical electric field for point ablation of the target tissue area. For example, one of the conductive framework 3 and the at least one second electrode 6 is designated as the positive electrode, and the other as the negative electrode, forming a positive-negative electrode circuit between the at least one second electrode 6 and the conductive framework 3. The positive and negative electrodes are connected to the energy generator of the pulse ablation device 30. When the pulse ablation device 30 emits pulse energy, a spherical electric field is formed between the positive and negative electrodes, causing irreversible electroporation damage to the target tissue at the treatment site. Under the spherical electric field, the first ablation component 101 can form a point ablation zone.

[0126] In this embodiment, the conductive frame 3 serves as the positive electrode, and at least one secondary rod 4 serves as the negative electrode; or, at least one second electrode 6 is paired with the conductive frame 3 to form a positive and negative electrode circuit; or, at least one second electrode 6 serves as the positive electrode, and at least one secondary rod 4 serves as the negative electrode; or, the conductive frame 3 and at least one second electrode group 63 serve as the positive electrode, and at least one first electrode 5 serves as the negative electrode. Compared with the prior art, the ablation catheter 10 in this application does not require an additional negative electrode plate for attaching to the patient's back. Ablation is performed using the positive and negative electrodes of the ablation catheter 10 itself, forming bipolar pulse ablation. On the one hand, the bipolar pulse ablation method eliminates the need for an external negative electrode plate, thereby reducing muscle stimulation and helping to improve the ablation effect. On the other hand, the current generated by the discharge of the conductive frame 3, or the current generated by the discharge of the conductive frame 3 and multiple second electrodes 6, is directly transmitted through the patient tissue to multiple secondary rods 4, and finally returns to the ablation system 100 through wires to form a circuit, resulting in a shorter distance between the conductive frame 3 and the secondary rods 4. Therefore, the ablation catheter 10 consumes less energy and has a faster ablation speed during ablation.

[0127] In some embodiments, the conductive framework 3 and / or at least one second electrode group 63 are paired with the auxiliary rod 4 and electrically connected to the energy generator to deliver the pulsed ablation energy output by the energy generator to the target tissue area. Specific embodiments can refer to the pairing method of the conductive framework 3 and / or at least one second electrode 6 with the auxiliary rod 4 described above, and will not be repeated here.

[0128] Please refer to it again. Figure 13 and Figure 14 In some embodiments, when the second ablation component 102 performs discharge ablation, it is in an expanded state, with adjacent secondary rods 4 set as positive and negative electrodes respectively. That is, the six secondary rods 4 are set as three positive and three negative electrodes, with the positive and negative electrodes alternating. In this embodiment, an electric field is formed between every two adjacent secondary rods 4, creating electric fields in six directions, which is beneficial for creating large-area damage and enabling rapid pulmonary vein isolation.

[0129] In some embodiments, when a certain tissue area of ​​the patient needs ablation, the curvature of the auxiliary rod 4 is adjusted to ensure its contact with the atrial wall. The portion of the auxiliary rod 4 with good contact with the atrial wall can be selected for discharge, while the conduction between the other auxiliary rods 4 and the energy generator is shut off. For example, two adjacent auxiliary rods 4 can be selected for discharge, with one rod 4 designated as the positive electrode and the other as the negative electrode. The other auxiliary rods 4 do not participate in the discharge, and an electric field is formed only between these two adjacent auxiliary rods 4, thus forming a linear lesion area. Alternatively, a portion of the auxiliary rods 4 can be selected for discharge, while the other portion does not participate. In this portion of the auxiliary rods 4 participating in the discharge, at least one auxiliary rod 4 is designated as the positive electrode, at least one as the negative electrode, and the remaining auxiliary rods 4 can be designated as either positive or negative. Furthermore, the polarity of the auxiliary rods 4 can be adjusted according to the structure of the target tissue, and an electric field is formed between the auxiliary rods 4 participating in the discharge.

[0130] In this embodiment, selectively discharging a portion of the secondary rods 4 avoids damaging unintended tissues by discharging multiple secondary rods 4 simultaneously. The ablation energy can be targeted to the tissue requiring ablation, preventing energy loss due to discharge from secondary rods 4 in non-adhesive areas, increasing energy utilization, reducing energy dissipation in the blood, and avoiding discharge into empty space, thus reducing unnecessary bubbles generated during blood electrolysis. Furthermore, with the same ablation parameters, the reduced discharge area when only some secondary rods 4 are discharged allows for deeper ablation damage. Discharging only some secondary rods 4 eliminates the need to energize all of them, reducing the total current during ablation and minimizing potential bodily irritation.

[0131] The foregoing display and description provide a detailed overview of the basic principles, main features, and advantages of this application. Those skilled in the art will understand these principles upon reading them; therefore, this application is not limited to the structural examples described above. The structural examples and specific implementations described above only illustrate the principles of this application. Other variations and modifications may be made to this application without departing from its principles and scope, and all such variations and modifications must fall within the scope of this application as claimed.

Claims

1. An ablation catheter, characterized in that, outer tube; An inner tube, which is coaxially and movably inserted into the outer tube; The first ablation component is located at the distal end of the inner tube and is used to perform point ablation on the target tissue area; The second ablation component is located at the proximal end of the first ablation component, and its proximal end is connected to the distal end of the outer tube. The second ablation component is used to perform circumferential ablation on the target tissue area. The first ablation component includes a conductive skeleton and a plurality of electrode groups disposed on the conductive skeleton. The conductive skeleton is movably installed at the distal end of the inner tube. When the conductive skeleton is retracted inside the inner tube, the first ablation component is in a retracted state; when the conductive skeleton is exposed outside the inner tube, the first ablation component is in an expanded state. The conductive skeleton is conductive and can form a spherical electric field to perform point ablation on the target tissue area. The conductive framework includes a central grid and multiple edge grid groups. The central grid is located at the far end of the conductive framework, and the center of the central grid is located on the central axis of the ablation catheter. The central grid is polygonal, and the multiple edge grid groups are arranged circumferentially around the central grid and are rotationally symmetrical about the central axis. Each edge mesh group includes a first edge mesh and a second edge mesh. Two adjacent first edge meshes and the center mesh form a first mesh structure. The center of the first mesh structure forms a first mesh node. The first edge mesh, the second edge mesh, and the first edge mesh of the adjacent edge mesh group form a second mesh structure. The center of the second mesh structure forms a second mesh node. Each electrode group includes two second electrodes. The two second electrodes are respectively fixed to the first mesh node and the second mesh node.

2. The ablation catheter according to claim 1, characterized in that, Both the first ablation component and the second ablation component have a contracted state and an expanded state. Both the first ablation component and the second ablation component ablate the target tissue area in the expanded state. When the first ablation component is in the expanded state, the second ablation component is in the contracted or expanded state. When the second ablation component is in the expanded state, the first ablation component is in the contracted or expanded state.

3. The ablation catheter according to claim 2, characterized in that, The second ablation assembly includes a plurality of auxiliary rods arranged around the inner tube and spaced apart from each other. The distal end of each auxiliary rod is fixed to the distal end of the inner tube, and the proximal end of each auxiliary rod is fixed to the distal end of the outer tube.

4. The ablation catheter according to claim 3, characterized in that, The second ablation assembly also includes a plurality of first electrodes disposed on the sub-rod. The plurality of first electrodes can form a ring-shaped electric field to perform ring-shaped ablation on the target tissue area.

5. The ablation catheter according to claim 4, characterized in that, The secondary rod includes a bearing section disposed adjacent to its distal end, and the first electrode is disposed on the bearing section.

6. The ablation catheter according to claim 4, characterized in that, The first electrodes on the same sub-rod have the same polarity. In adjacent sub-rods, the first electrodes are arranged one-to-one along the axial direction of the second ablation assembly and the polarities of the corresponding first electrodes are opposite. Multiple first electrodes are arranged in at least one ring around the circumference of the second ablation component, and multiple first electrodes in each ring form a ring-shaped electric field to perform ring-shaped ablation on the target tissue area.

7. The ablation catheter according to claim 3, characterized in that, The inner tube can move proximally or distally relative to the outer tube to switch the second ablation component between an expanded state and a contracted state. When the second ablation component is in the expanded state, the middle portion of the secondary rod is away from the central axis of the inner tube, and the secondary rod is arc-shaped; or, the proximal and distal ends of the secondary rod converge, and the secondary rod forms a ring. When the second ablation component is in the contracted state, the middle portion of the secondary rod is close to the central axis of the inner tube, and the secondary rod is linear.

8. The ablation catheter according to claim 3, characterized in that, Multiple auxiliary rods are arranged symmetrically around the axial direction of the inner tube.

9. The ablation catheter according to claim 3, characterized in that, The ablation catheter further includes a first connector and a second connector. The first connector is fixedly connected to the distal ends of the plurality of auxiliary rods and to the distal end of the inner tube. The second connector is fixedly connected to the proximal ends of the plurality of auxiliary rods and to the distal end of the outer tube.

10. The ablation catheter according to claim 4 or 5, characterized in that, The conductive framework is paired with at least one of the first electrodes to form a spherical electric field, or the conductive framework is paired with an external negative electrode plate to form a spherical electric field for point ablation of the target tissue area.

11. The ablation catheter according to claim 4 or 5, characterized in that, Multiple electrode groups are arranged to rotate around the central axis of the conductive skeleton, and each electrode group includes at least two second electrodes for mapping electrocardiogram signals in the target tissue area.

12. The ablation catheter according to claim 11, characterized in that, The second electrode is also used for ablation, and the conductive skeleton is paired with at least one of the second electrodes to form a spherical electric field for point ablation of the target tissue area.

13. The ablation catheter according to claim 11, characterized in that, The second electrode is also used for ablation, and at least one second electrode is paired with at least one first electrode to form a local electric field for local ablation of the target tissue area.

14. The ablation catheter according to claim 11, characterized in that, The first electrode is also used to map electrocardiogram signals to the target tissue area.

15. The ablation catheter according to claim 11, characterized in that, The ablation catheter also includes a reference electrode located at the proximal end of the conductive framework. The reference electrode is used for electrocardiogram signal mapping to obtain a reference potential.

16. The ablation catheter according to claim 4 or 5, characterized in that, The ablation catheter also includes an infusion catheter, which is located inside the inner tube and has its distal end located inside the conductive skeleton. The infusion catheter is used to infuse flushing liquid into the conductive skeleton.

17. An ablation system, characterized in that, It includes a pulse ablation device and an ablation catheter as described in any one of claims 1 to 16, wherein the ablation catheter is connected to the pulse ablation device.

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