Ablation device and ablation system

Abstract

The application provides an ablation device, which comprises an ablation assembly and an adjusting assembly arranged at the proximal end of the ablation assembly, the adjusting assembly comprises an outer tube and an inner tube which both extend in the axial direction, the ablation assembly comprises a supporting framework and an ablation element arranged on the supporting framework, the supporting framework comprises a positioning frame and a bearing frame, the positioning frame is arranged at the distal end relative to the bearing frame, the distal end of the outer tube is connected to the proximal end of the bearing frame, the distal end of the inner tube is connected to the distal end of the positioning frame, the supporting framework is deformed in the movement of the inner tube relative to the outer tube, and the deformation ratio of the positioning frame is smaller than that of the bearing frame. The application also relates to an ablation system provided with the ablation device.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical devices, and relates to an ablation device and an ablation system provided with the ablation device. BACKGROUND

[0002] Atrial fibrillation (AF) is the most common sustained arrhythmia, and the incidence of AF increases with age, up to 10% in people over 75 years old. When atrial fibrillation occurs, the frequency of atrial activation is 300-600 times per minute, and the heart rate is often fast and irregular, sometimes up to 100-160 times per minute, which is not only much faster than normal, but also absolutely irregular, and the atrium loses effective contraction function. Atrial fibrillation usually increases the risk of obtaining many potentially fatal complications, including thromboembolic stroke, dilated cardiomyopathy and congestive heart failure. Common symptoms of AF such as palpitations, chest pain, shortness of breath, fatigue and dizziness also affect the quality of life. Compared with normal people, the average incidence of people with atrial fibrillation increases by five times, and the mortality rate increases by two times.

[0003] Tissue ablation is usually used to treat various arrhythmias, including atrial fibrillation. In order to treat arrhythmia, ablation can be performed using an ablation catheter to change tissue, for example, to stop abnormal electrical propagation and / or to disrupt abnormal electrical conduction through cardiac tissue. Ablation therapy includes both thermal ablation, such as radiofrequency ablation, laser ablation, microwave ablation, thermal substance ablation, etc., and pulse ablation using the principle of bioelectric perforation.

[0004] When ablation is performed on the pulmonary vein using an ablation catheter, it is actually difficult to position the distal end of the ablation catheter around the ostium of the pulmonary vein and point to the center of the pulmonary vein while sliding the ablation catheter along the atrial wall. Even if an electrophysiologist can guide the ablation catheter to the ostium, due to the fact that the distal end of the ablation catheter does not have any support point in the atrium, the periodic blood flow through the pulmonary vein can force the ablation catheter away from the atrial wall, so that the distal end of the ablation catheter cannot be positioned at the ostium of the pulmonary vein, and the ablation catheter cannot form a complete ablation region of at least one circle after entering the pulmonary vein. SUMMARY

[0005] The present application aims to provide an ablation device that is easier to position at the ostium of the pulmonary vein when ablation is performed on the pulmonary vein, so as to ensure that the ablation device can form a complete ablation region of at least one circle after entering the pulmonary vein.

[0006] To solve the above technical problems, the present application provides an ablation device, which comprises an ablation assembly and an adjusting assembly arranged at the proximal end of the ablation assembly, the adjusting assembly comprises an outer tube and an inner tube which both extend in the axial direction, the ablation assembly comprises a supporting framework and an ablation element arranged on the supporting framework, the supporting framework comprises a positioning frame and a bearing frame, the positioning frame is arranged at the distal end relative to the bearing frame, the distal end of the outer tube is connected to the proximal end of the bearing frame, the distal end of the inner tube is connected to the distal end of the positioning frame, and the supporting framework is deformed in the process of moving the inner tube relative to the outer tube, and the deformation ratio of the positioning frame is smaller than that of the bearing frame.

[0007] The present application also provides an ablation system, which comprises a mapping device and the ablation device, the inner tube is a hollow tube, the mapping device comprises a mapping catheter and a mapping electrode arranged at the distal end of the mapping catheter, the mapping catheter is inserted into the inner tube, and the mapping electrode extends out of the distal end of the inner tube to adhere to the tissue wall to detect the electrophysiological signal in the target tissue region.

[0008] The supporting framework of the ablation device of the present application comprises a positioning frame and a bearing frame, the positioning frame is arranged at the distal end relative to the bearing frame, the distal end of the outer tube is connected to the proximal end of the bearing frame, the distal end of the inner tube is connected to the distal end of the positioning frame, the supporting framework is deformed in the process of moving the inner tube relative to the outer tube, and the deformation ratio of the positioning frame is smaller than that of the bearing frame. Therefore, the bearing frame is easy to change the radial size to adhere to the target tissue region in the process of deformation, and the deformation ratio of the positioning frame is smaller, which is more likely to maintain the original shape relative to the bearing frame, the positioning frame is located at the distal end of the ablation device and is used for positioning in the pulmonary vein, that is, the positioning frame is inserted into the pulmonary vein opening, so that the ablation device can have a better centering effect, which is beneficial to forming a complete annular ablation region around the pulmonary vein opening; and the problem that the positioning frame is deformed too much in the process of adjusting the diameter of the bearing frame and cannot press against the inner wall of the pulmonary vein, so that the ablation assembly cannot be aligned around the pulmonary vein opening and discontinuous ablation region is generated is avoided. BRIEF DESCRIPTION OF DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0010] Figure 1 is a schematic diagram of the ablation system provided by the first embodiment of the present application;

[0011] Figure 2 yes Figure 1 Enlarged three-dimensional structural diagram of the ablation components, mapping device, and part of the outer and inner tubes;

[0012] Figure 3 yes Figure 1 A partially enlarged schematic diagram of the ablation device in the image;

[0013] Figure 4 yes Figure 3 A three-dimensional structural diagram of one of the usage states of the ablation component in the process;

[0014] Figure 5 yes Figure 4 Side view of the ablation component;

[0015] Figure 6 This is a schematic diagram of the ablation component provided in the second embodiment of the present invention;

[0016] Figure 7 yes Figure 6 A three-dimensional structural diagram of one of the usage states of the ablation component in the process;

[0017] Figure 8 yes Figure 7 A side view of the ablation component in the image;

[0018] Figure 9 yes Figure 7 A schematic diagram of the volume electric field of the ablation component in the process;

[0019] Figure 10 This is a schematic diagram of the ablation component provided in the third embodiment of the present invention;

[0020] Figure 11 yes Figure 10 A top view of the ablation component in the image;

[0021] Figure 12 yes Figure 10 A three-dimensional structural diagram of one of the usage states of the ablation component in the process;

[0022] Figure 13 yes Figure 12 A top view of the ablation component in the image;

[0023] Figure 14 This is a schematic diagram of the ablation component provided in the fourth embodiment of the present invention;

[0024] Figure 15 yes Figure 14 A top view of the ablation component in the image;

[0025] Figure 16 This is a schematic diagram of the ablation component provided in the fifth embodiment of the present invention;

[0026] Figure 17 is Figure 16 is one of the use state diagram of the ablation assembly in DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative effort fall within the protection scope of the present application.

[0028] In the description of the present application, the "proximal end" refers to the end close to the operator during the operation, and the "distal end" refers to the end away from the operator during the operation. The axial direction refers to the direction of the central axis of the device, and the radial direction refers to the direction perpendicular to the central axis. The definition is only for the convenience of description, and cannot be understood as a limitation on the present application. The "connection between component A and component B" refers to the direct contact connection between component A and component B, or the indirect connection between component A and component B through other components.

[0029] Please refer to Figures 1 to 5 The present application provides an ablation system, which comprises an ablation device 100 and a mapping device 30. The ablation device 100 comprises an ablation assembly 20 and an adjusting assembly 50 arranged at the proximal end of the ablation assembly 20. The adjusting assembly 50 comprises an outer tube 52, an inner tube 54 and a handle 55, which all extend in the axial direction. The ablation assembly 20 comprises a support framework 21 and an ablation element 25 arranged on the support framework 21. The support framework 21 comprises a positioning frame 22 and a bearing frame 24. The positioning frame 22 is arranged at the distal end relative to the bearing frame 24. The distal end of the outer tube 52 is connected to the proximal end of the bearing frame 24, the distal end of the inner tube 54 is connected to the distal end of the positioning frame 22, and the proximal end of the positioning frame 22 is connected to the distal end of the bearing frame 24. During the axial movement of the inner tube 54 relative to the outer tube 52, the support framework 21 deforms, and the deformation ratio of the positioning frame 22 is smaller than that of the bearing frame 24.

[0030] The deformation ratio refers to the ratio of the size of the frame body in the fully released state to the size after deformation. For example, in the axial direction, let the size of the frame body in the fully released state be L1, and the size of the frame body after deformation be L2. The deformation ratio is denoted as a, and a = (L1-L2) / L1.

[0031] Specifically, in the axial direction, let the size of the positioning frame 22 in the fully released state be m1, and the size of the positioning frame 22 after deformation be m2. The deformation ratio is denoted as a1, and a1 = (m1-m2) / m1.

[0032] Specifically, in the axial direction, let the size of the bearing frame 24 in the fully released state be n1, let the size of the bearing frame 24 after deformation be n2, and let the deformation ratio be a2, then a2=(n1-n2) / n1.

[0033] The deformation ratio of the positioning frame 22 is less than the deformation ratio of the bearing frame 24, so a1

[0034] In this embodiment, in the fully released state, both the positioning frame 22 and the bearing frame 24 are frame structures with internal cavities, and the radial and axial dimensions of the positioning frame 22 are both less than the radial and axial dimensions of the bearing frame 24. In the alternative embodiment, the radial and / or axial dimensions of the positioning frame 22 are greater than or equal to the radial and axial dimensions of the bearing frame 24.

[0035] The support framework 21 is at least one of a mesh structure, a rod structure, or a frame structure. The support framework 21 can be cut from an elastic metal pipe, woven from an elastic metal wire, or processed by local weaving combined with local pipe cutting. Different parts can be welded or fixed to each other by connectors. The pipe material is metal or non-metal material, preferably memory metal material, preferably nickel-titanium alloy material. In this embodiment, the support framework 21 is cut and shaped from a nickel-titanium alloy pipe, and the cross section of the cut rod surrounding the positioning frame 22 is the same as the cross section of the cut rod surrounding the bearing frame 24. When the inner tube 54 moves relative to the outer tube 52, the deformation ratio of the cut rod of the positioning frame 22 is less than the deformation ratio of the cut rod of the bearing frame 24.

[0036] Specifically, in the process of deformation, the deformation ratio of the positioning frame 22 in the axial and radial directions is less than the deformation ratio of the bearing frame 24 in the axial and radial directions.

[0037] As Figures 3 to 5As shown, the positioning frame 22 and the bearing frame 24 are both grid structures, the positioning frame 22 is formed with mesh holes 220, the bearing frame 24 is formed with mesh holes 240, the opening area of the mesh holes 220 in the positioning frame 22 is smaller than the opening area of the mesh holes 240 in the bearing frame 24, and the adjacent wire rods in the grid of the positioning frame 22 are connected to each other, so that the positioning frame 24 is not easy to deform. In the embodiment, since the cross section of the cutting rod of the positioning frame 22 is the same as the cross section of the cutting rod of the bearing frame 24, and the size of the mesh hole 220 is smaller than the size of the mesh hole 240, for example, in the embodiment, the mesh hole 220 and the mesh hole 240 are both in the shape of a long strip, and in the fully released state, the opening area of the mesh hole 220 is smaller than the opening area of the mesh hole 240; since the grid of the bearing frame 24 is relatively larger than the grid of the positioning frame 22, when the outer tube 52 and the inner tube 54 relatively move, the bearing frame 24 is more likely to deform than the positioning frame 22 to be close to the target tissue area; the mesh hole of the positioning frame 22 is smaller, and the wire rods in the positioning frame 22 are connected to each other to restrict, so that the deformation ratio of the positioning frame 22 is smaller, and the positioning frame 22 is more likely to keep the original shape than the bearing frame 24, so that a better centering effect can be kept, that is, the ablation assembly 20 is positioned at the pulmonary vein ostium, and the axis thereof is more likely to be aligned with the center of the pulmonary vein; and the problem that the positioning frame 22 deforms too much and cannot abut against the inner walls of the pulmonary vein during adjustment of the diameter of the bearing frame 24, so that the ablation assembly 20 cannot be aligned around the pulmonary vein ostium is avoided. In addition, the contour change ratio of the positioning frame 22 is not large, and the positioning frame 22 protrudes from the bearing frame 24 in the axial direction, so that the ablation assembly 20 is facilitated to enter the pulmonary vein, and the bearing frame 24 is positioned around the pulmonary vein ostium.

[0038] In other embodiments, the cross section of the cutting rod surrounding the positioning frame 22 is larger than the cross section of the cutting rod surrounding the bearing frame 24, that is, the cross section of the single rod body in the positioning frame 22 is larger in at least one direction compared with the bearing frame 24, that is, the wire diameter of the single rod body in the positioning frame 22 is larger compared with the bearing frame 24, and the opening area of the mesh hole of the positioning frame 22 is not larger than the opening area of the mesh hole of the bearing frame 24; so that during deformation of the support framework 21, the deformation ratio of the positioning frame 22 is smaller than the deformation ratio of the bearing frame 24.

[0039] In other embodiments, the rigidity of the cutting rod of the positioning frame 22 is larger than or equal to the rigidity of the cutting rod of the bearing frame 24, so that during deformation of the support framework 21, the positioning frame 22 is less likely to elastically deform compared with the bearing frame 24.

[0040] In other embodiments, the positioning frame 22 and the bearing frame 24 are formed by material wires, the wire diameter of the material wires of the positioning frame 22 is greater than or equal to the wire diameter of the material wires of the bearing frame 24, and the mesh opening area of the positioning frame 22 is less than or equal to the mesh opening area of the bearing frame 24; so that the deformation ratio of the positioning frame 22 is less than the deformation ratio of the bearing frame 24 in the process of deformation of the support skeleton 21.

[0041] Further, the rigidity of the material wires of the positioning frame 22 is greater than or equal to the rigidity of the material wires of the bearing frame 24; so that the deformation ratio of the positioning frame 22 is less than the deformation ratio of the bearing frame 24 in the process of deformation of the support skeleton 21.

[0042] Optionally, the outer tube 52 and the inner tube 54 are both hollow tubes, and the inner tube 54 is arranged in the outer tube 52, that is, the inner tube 54 is movably inserted into the inner cavity of the outer tube 52; the inner tube 54 moves axially relative to the outer tube 52, and the axial size and the radial size of the support skeleton 21 change. Specifically, in the process that the inner tube 54 moves axially towards the proximal end relative to the outer tube 52, the axial size of the bearing frame 24 decreases and the radial size increases; in the process that the inner tube 54 moves axially towards the distal end relative to the outer tube 52, the axial size of the bearing frame 24 increases and the radial size decreases.

[0043] In other embodiments, the inner tube 54 can also rotate relative to the outer tube 52 to make the material wires or cutting rods of the bearing frame 24 deformed into a spiral shape.

[0044] As shown in FIG. 1, the positioning frame 22 and the bearing frame 24 are arranged in a mesh shape, and the positioning frame 22 is arranged at the distal end of the bearing frame 24. Figure 3 As shown in FIG. 2, the positioning frame 22 includes a plurality of first main rods 221 and a plurality of first branch rods 225, the plurality of first main rods 221 are arranged along the circumference of the inner tube 54, the distal end of each first main rod 221 is connected to the inner tube 54, and the proximal end of each first main rod 221 is connected to a corresponding plurality of first branch rods 225; the bearing frame 24 includes a plurality of bearing rods 241, the plurality of bearing rods 241 are arranged along the circumference of the inner tube 54, the distal end of each bearing rod 241 is connected to a corresponding plurality of first branch rods 225, and the other end of the plurality of first branch rods 225 connected to the same bearing rod 241 is connected to different first main rods 221.

[0045] The positioning frame 22 is arranged in a mesh shape at the distal end of the bearing frame 24, and the bearing frame 24 is also arranged in a mesh shape at the proximal end of the positioning frame 22; the positioning frame 22 is used to be inserted into the pulmonary vein in the process of ablation, has a guiding and positioning function, and facilitates the bearing frame 24 to form a closed annular ablation area at the pulmonary vein ostium, thereby improving the accuracy of ablation and the success rate of the operation.

[0046] In the embodiment, the positioning frame 22 and the bearing frame 24 are integrally cut and shaped by using a nickel-titanium tube. The positioning frame 22 includes six first main rods 221 and two first sub- rods 225 connected to the proximal end of each first main rod 221. The first main rods 221 are arranged along the circumference of the inner tube 54, preferably uniformly. The bearing frame 24 includes six bearing rods 241 arranged along the circumference of the inner tube 54, preferably uniformly. The distal end of each main rod 221 is connected to the distal end of the inner tube 54, and the bearing rods 241 are connected to the first main rods 221 through the first sub-rods 225. Specifically, the proximal end of each main rod 221 is connected to two first sub-rods 225, and the distal end of each bearing rod 241 is connected to two first sub-rods 225, and the distal ends of the two first sub-rods 225 connected to the distal end of each bearing rod 241 are connected to different first main rods 221. In the fully released state of the support framework 21, the radial dimension of the frame surrounded by the first main rods 221 and the first sub-rods 225 is smaller than the radial dimension of the frame surrounded by the bearing rods 241. The bearing rods 241 are provided with ablation elements 25, specifically, ablation electrodes. At least one of the bearing rods 241 in the bearing frame 24 is provided with an ablation electrode, specifically, one of the bearing rods 241 in the bearing frame 24 can be provided with an ablation electrode, each of the bearing rods 241 can be provided with an ablation electrode, or several of the bearing rods 241 that are spaced or adjacent to each other can be provided with ablation electrodes. When the ablation device 100 is used, the ablation elements 25 on the bearing rods 241 are used for annular ablation, such as annular ablation at the ostium of the pulmonary vein. The inner tube 54 of the adjustment assembly 50 is movably inserted into the outer tube 52, the distal end of the inner tube 54 can be extended from the distal end opening of the outer tube 52, the distal end of the inner tube 54 is combined with the distal end of the positioning frame 22, and the proximal end of the bearing frame 24 is combined with the distal end of the outer tube 52. By controlling the relative position between the inner tube 54 and the outer tube 52, the axial length of the bearing frame 24 is controlled, thereby adjusting the diameter of the bearing frame 24, so that the diameter of the bearing frame 24 matches the annular size of the target ablation region.

[0047] As Figure 3As shown, the proximal end of each first main rod 221 is connected with two corresponding first sub-rod 225, the other end of the two first sub-rod 225 connected with the proximal end of each first main rod 221 extends in a direction away from each other, the proximal end of each first sub-rod 225 is combined with the proximal end of the adjacent first sub-rod 225, that is, the proximal end of each first sub-rod 225 is not connected with the distal end of the first sub-rod 225, the combination point of the proximal end of the first sub-rod 225 is connected with the distal end of a carrier rod 241, and the combination point of the distal end of the first sub-rod 225 is connected with the proximal end of a first main rod 221. A plurality of first sub-rod 225 are arranged in the circumferential direction of the inner tube 54, and the first sub-rod 225 are connected end to end to form a wave-shaped ring structure, the proximal end of each first main rod 221 is connected with the corresponding wave crest of the wave-shaped ring structure, and the distal end of each carrier rod 241 is connected with the corresponding wave trough of the wave-shaped ring structure. In this embodiment, the end of the first sub-rod 225 for connecting the carrier rod 241 extends proximally relative to the end for connecting the first main rod 221. In a modified embodiment, the end of the first sub-rod 225 for connecting the carrier rod 241 extends distally relative to the end for connecting the first main rod 221, that is, the proximal end of each first main rod 221 is connected with the corresponding wave trough of the wave-shaped ring structure, and the distal end of each carrier rod 241 is connected with the corresponding wave crest of the wave-shaped ring structure.

[0048] Preferably, the intersection of each first main rod 221 and the corresponding plurality of first sub-rod 225 is bent to the side away from the inner tube 54, the middle part of each carrier rod 241 is bent to the side away from the inner tube 54, and the connection between the distal end of each carrier rod 241 and the corresponding plurality of first sub-rod 225 is bent to the side close to the inner tube 54; that is, the intersection of each first main rod 221 and the corresponding plurality of first sub-rod 225 protrudes in the direction away from the inner tube 54, the middle part of each carrier rod 241 protrudes in the direction away from the inner tube 54, and the connection between the distal end of each carrier rod 241 and the corresponding plurality of first sub-rod 225 is recessed in the direction close to the inner tube 54, so that the carrier frame 24 is more easily deformed than the positioning frame 22 during the deformation of the ablation assembly 20. When the relative position relationship between the inner tube 54 and the outer tube 52 is adjusted to adjust the outer diameter of the carrier frame 24, the first sub-rod 225 pulls the first main rod 221 in the axial and radial directions due to the constraint of the two first sub-rod 225 combined together between the two adjacent first main rod 221, so that the deformation of the first main rod 221 in the radial and axial directions is not too large, which is beneficial to the positioning frame 22 to maintain the basket shape, thereby maintaining a better centering effect during the change of the ablation diameter range of the ablation device 100. It avoids that the positioning frame 22 is deformed too much during the adjustment of the diameter of the carrier frame 24, and cannot be pressed against the inner walls of the pulmonary veins, resulting in the problem that the ablation assembly 20 cannot be aligned around the pulmonary vein orifice.

[0049] In the embodiment, a row of meshes 220 is formed in the axial direction of the positioning frame 22.

[0050] In other alternative embodiments, a plurality of struts are connected to the proximal end of the first struts along the circumferential direction of the inner tube 54 to form two rows of meshes 220 in the axial direction of the positioning frame 22, the proximal end of the first struts being connected to the proximal end or the distal end of the struts. In other alternative embodiments, the proximal end of the first main strut 221 is connected to more than two struts; the first main strut 221, the first struts 225 and the struts can be in a straight line, a helical line or other curved lines; in the embodiment, the width of the first main strut 221 and / or the first struts 225 is less than or equal to the width of the carrier struts 241, so as to facilitate the retraction into a sheath with a smaller diameter for in-vivo delivery.

[0051] The carrier struts 241, the first struts 225 and the struts in the carrier frame 24 can be in a straight line, a helical line or other curved lines, the helical line can be obtained by cutting and heat setting, or the helical line of the carrier struts 241 can be obtained by rotating the inner tube 54 relative to the outer tube 52 during implantation to form the above-mentioned helical structure.

[0052] The carrier struts 241 in the carrier frame 24 are connected to each other to form a grid and meshes, the shape of the meshes 240 can be arbitrary, and the carrier struts 241 extend in the axial direction and / or the radial direction. At least part of the carrier struts 241 are provided with electrodes.

[0053] The carrier 24 can be made of metal materials such as nickel-titanium wires, and the cross-sectional shape of the nickel-titanium wires can be circular, semi-circular or other geometric shapes.

[0054] Preferably, as shown in Figure 3 The support skeleton 21 further comprises a connecting frame 26 connected between the carrier frame 24 and the outer tube 25, and the deformation ratio of the connecting frame 26 is greater than that of the positioning frame 22 during deformation of the support skeleton 21.

[0055] Specifically, in the fully released state, the connecting frame 26 is a frame structure with an inner cavity, and the deformation ratio of the positioning frame 22 is smaller than that of the connecting frame 26. In the embodiment, the cross section of the cutting rod surrounding the connecting frame 26 is the same as that of the cutting rod surrounding the positioning frame 22 and that of the cutting rod surrounding the bearing frame 24. When the inner tube 54 moves relative to the outer tube 52, the deformation ratio of the cutting rod of the positioning frame 22 is smaller than that of the connecting frame 26. The connecting frame 26 is also a grid structure, and the connecting frame 26 is formed with mesh holes 260, and the opening size of the mesh holes 260 of the connecting frame 26 is smaller than that of the mesh holes 240 of the bearing frame 24, that is, the opening area of the mesh holes 260 of the connecting frame 26 is smaller than that of the mesh holes 240 of the bearing frame 24. The opening size of the mesh holes 260 of the connecting frame 26 is larger than that of the mesh holes 220 of the positioning frame 22, that is, the opening area of the mesh holes 260 of the connecting frame 26 is smaller than that of the mesh holes 240 of the bearing frame 24. In the embodiment, since the cross section of the cutting rod of the positioning frame 22, the cross section of the cutting rod of the bearing frame 24 and the cross section of the cutting rod of the connecting frame 26 are the same, and the opening area of the mesh holes 220 is smaller than that of the mesh holes 260, therefore, during the relative movement of the outer tube 52 and the inner tube 54, the connecting frame 26 is more easily deformed than the positioning frame 22. During the adjustment of the support skeleton 21, since the grid of the bearing frame 24 and the connecting frame 26 is relatively larger than that of the positioning frame 22, therefore, the bearing frame 24 and the connecting frame 26 are easily changed in radial dimension during deformation to close to the target tissue area.

[0056] The connecting frame 26 includes a plurality of second main rods 261 and a plurality of second sub rods 265, the plurality of second main rods 261 are arranged along the circumference of the outer tube 52, the proximal end of each second main rod 261 is connected to the outer tube 52, the distal end of each second main rod 261 is connected to a corresponding plurality of second sub rods 265, the proximal end of each bearing rod 241 is connected to a corresponding plurality of second sub rods 265, and the other end of the plurality of second sub rods 265 connected to the same bearing rod 241 is connected to different second main rods 261, and the distal end of each bearing rod 241 is connected to the positioning frame.

[0057] In this embodiment, the positioning frame 22, the bearing frame 24, and the connecting frame 26 are integrally cut and shaped using a nickel-titanium tube. The connecting frame 26 includes six second main rods 261 and two second branch rods 265 connected to the distal end of each second main rod 261. Several second main rods 261 are arranged circumferentially along the outer tube 52. Preferably, these second main rods 261 are evenly arranged circumferentially along the outer tube 52. The proximal end of each second main rod 261 is connected to the distal end of the outer tube 52, and the bearing rod 241 is connected to the second main rod 261 via the second branch rods 265. Specifically, the distal end of each second main rod 261 is connected to two second branch rods 265, the proximal end of each bearing rod 241 is connected to two second branch rods 265, and the distal ends of the two second branch rods 265 connected to the proximal end of each bearing rod 241 are respectively connected to different second main rods 261. In this embodiment, when the support frame 21 is fully released, the radial dimension of the frame formed by several second main rods 261 and several second branch rods 265 is smaller than the radial dimension of the frame formed by several bearing rods 241. The distal end of the inner tube 54 is connected to the distal end of the positioning frame 22, and the proximal end of the connecting frame 26 is connected to the distal end of the outer tube 52. By controlling the relative positional relationship between the inner tube 54 and the outer tube 52, the axial length of the bearing frame 24 is controlled, thereby adjusting the diameter of the bearing frame 24 so that the diameter of the bearing frame 24 matches the annular size of the target ablation area.

[0058] like Figure 3 As shown, the distal end of each second main rod 261 is connected to two corresponding second branch rods 265. The distal ends of the other ends of the two second branch rods 265 connected to the distal end of each second main rod 261 extend in opposite directions. The distal end of each second branch rod 265 is combined with the distal end of the adjacent second branch rod 265. That is, the distal end of each second branch rod 265 is different from the second branch rod 265 connected to its proximal end. The joint point of the distal end of the second branch rod 265 is connected to the proximal end of a bearing rod 241, and the joint point of the proximal end of the second branch rod 265 is connected to the proximal end of a second main rod 261. A plurality of second branch rods 265 are arranged circumferentially along the inner tube 54, and the ends of the plurality of second branch rods 265 are connected to form a wave-shaped ring structure. The distal end of each second main rod 261 is connected to the trough of the wave-shaped ring structure, and the proximal end of each bearing rod 241 is connected to the crest of the wave-shaped ring structure. In the modified embodiment, the distal end of each second main rod 261 is connected to the wave crest corresponding to the waveform ring structure, and the proximal end of each bearing rod 241 is connected to the wave trough corresponding to the waveform ring structure.

[0059] Optionally, at least one ablation element 25 is arranged on the positioning frame 22 and / or the carrier frame 24, and the ablation element 25 is an ablation electrode; the ablation energy source connected to the ablation element 25 can be radio frequency, pulse or microwave. In the embodiment, the carrier rod 241 comprises a carrier segment 243 arranged adjacent to the distal end of the carrier rod 241, and the ablation electrode is arranged on the carrier segment 243; specifically, the ablation electrode is arranged on the side of the carrier segment 243 facing away from the inner tube 54.

[0060] When the ablation energy source connected to the ablation element 25 is radio frequency, an insulating layer is arranged on the carrier rod 241 at the position where the ablation electrode is not arranged. In the embodiment, the surface of the carrier rod 241 is vacuum-coated except the position where the ablation element 25 is arranged, so that the surface of the carrier rod 241 is covered with an insulating coating. The position where the ablation element 25 is arranged is exposed on the surface of the carrier rod 241, and the carrier rod 241 conducts electrical signals to perform ablation. Preferably, the ablation element 25 is arranged at the position where the compressed radial dimension of the carrier rod 241 is the largest.

[0061] When the ablation energy source connected to the ablation element 25 is pulse, the ablation element 25 is arranged on the carrier frame 24, i.e. the electrode is arranged on the carrier rod 241 alone, and the electrode is made of platinum-iridium alloy, gold or other platinum alloy, and each electrode has a wire with an insulating layer welded to the inner wall of the electrode. The carrier rod 241 comprises a nickel-titanium wire and an insulating sleeve or other high polymer insulating material arranged outside the nickel-titanium wire. The electrode is sleeved on the insulating sleeve to ensure the insulation between the electrode and the carrier rod 241. The insulating wire is arranged between the carrier rod 241 and the insulating sleeve or other high polymer material. The surface of the nickel-titanium wire is vacuum-coated to cover the surface with an insulating coating. That is, the inner surface of each electrode is connected to the ablation electrode connector 551 on the handle 55 through a wire from the surface of the insulating sleeve, along the nickel-titanium wire and through the inner tube 54. The ablation electrode connector 551 is electrically connected to the external pulse signal source, and the electrode and the wire are connected by welding or other special process. When the inner tube 54 is used to pull the carrier frame 24 to adjust the diameter, the diameter of the carrier rod 241 at the cross section is 10mm-36mm.

[0062] In one embodiment, the voltage of the pulse signal received by the ablation electrode ranges from 900V to 2400V, including all values and subranges therebetween; the pulse frequency ranges from 1kHz to 500kHz, including all values and subranges therebetween; the pulse energy can be a unipolar pulse high-voltage power supply or a bipolar high-voltage pulse power supply. In the bipolar high-voltage pulse signal waveform, the positive and negative polarity pulses alternate in each cycle, and the positive pulse voltage / negative pulse voltage=negative pulse width / positive pulse width=β is always satisfied, and β is continuously adjustable between 1 and 8. Accordingly, the maximum voltage borne by the wire is 3000V; the total ablation electrodes can be divided into one or more positive-negative sets.

[0063] The energy pulse train received by the ablation electrodes includes monophasic pulses or biphasic pulses, and wherein each ablation electrode can be configured with different parameters of the monophasic or biphasic pulses, such as voltage, pulse width, repetition frequency, duty cycle, and number of pulses.

[0064] The pulse ablation utilizes high-intensity pulse electric field to cause irreversible electrical breakdown of cell membrane, which is called irreversible electroporation in medical field, to cause cell apoptosis and thus achieve non-thermal effect ablation of cells, so as to be not affected by thermal sink effect. The high-voltage pulse sequence produces less heat, and physiological saline flushing is not needed for cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombus. The pulse ablation treatment time is short, and the treatment time of a group of pulse sequences is less than 1 minute, and the whole ablation time is generally not more than 5 minutes. Moreover, due to the differences in the response threshold of different tissues to pulse electric field, it is possible to ablate myocardium without interfering with other adjacent tissues, thereby avoiding the misinjury of the tissues adjacent to the pulmonary vein. In addition, compared with other energy, the pulse ablation does not need heat conduction to ablate deep tissues, and all myocardial cells distributed above a certain electric field intensity will be electroporated, which reduces the requirement for the ablation pressure of the catheter. Therefore, even if the ablation instrument does not completely adhere to the inner wall of the tissue after entering the atrium, it also does not affect the ablation effect. The electrode for applying pulse energy can also collect intracardiac electrical signals. Before ablation, the intracardiac electrocardiogram signal is transmitted to an electrocardiogram synchronizer to synchronize the pulse output in the absolute refractory period of myocardial contraction, so as to not interfere with the heart rate and reduce sudden arrhythmia; after ablation is completed, the intracardiac signal can also be used to determine whether the tissue has been completely electrically isolated.

[0065] Optionally, the inner tube 54 is a hollow tube, the mapping device 30 includes a mapping catheter 31, a mapping electrode 33 arranged at the distal end of the mapping catheter 31, and a mapping electrode connector 35 connected to the proximal end of the mapping catheter 31; the mapping catheter 31 is inserted into the inner tube 54, and the mapping electrode 33 extends out of the distal end of the inner tube 54 to adhere to the tissue wall to detect the electrophysiological signal in the target tissue region. Specifically, the distal end of the mapping catheter 31 extends out of the distal end of the inner tube 54 by at least one turn, and a plurality of mapping electrodes 33 are arranged at the distal end of the mapping catheter 31 in a spaced manner. The mapping catheter 31 is used to be inserted into the inner tube 54, and the mapping electrode 33 extends out of the opening at the distal end of the inner tube 54, and the mapping electrode 33 is used to adhere to the tissue wall to detect the electrophysiological signal in the target tissue region

[0066] In other embodiments, the ablation electrodes on the support skeleton 21 can be used for both ablation and electrophysiological signal mapping. If the ablation electrodes on the bearing frame 24 can be used for mapping, the inner tube 24 can be replaced by a pull wire. In one implementation, the ablation electrodes described above are used to perform other functions such as cardiac pacing.

[0067] Optionally, the proximal end of the bearing frame 24 is provided with a connecting frame 26 for maintaining the relative position relationship between adjacent bearing rods 241, so that the distance between the plurality of ablation elements 25 is not too close after the inner tube 54 is pulled, thereby avoiding the generation of electric arc; in addition, the uniformity of the plurality of bearing rods 241 distributed in the circumferential direction is improved, the bearing frame 24 as a whole is not easy to be twisted and deformed, the ablation precision of the ablation device 100 is improved, and the ablation efficiency is higher.

[0068] Optionally, in other embodiments, an electrode is arranged on the first main rod 221 and / or the first branch rod 225 of the positioning frame 22, and the arrangement mode of the electrode is referred to the arrangement mode of the electrode on the bearing frame 24, which will not be described here. Figure 1 The measuring catheter 31 in the ablation device 100 is omitted, and the inner tube 54 can be replaced by a pulling wire, which is beneficial to reduce the diameter of the outer tube 52.

[0069] As shown in Figure 1 , Figure 4 and Figure 5 , the outer diameter of the bearing frame 24 can be adjusted by pulling the inner tube 54 at the proximal end of the handle 55, so as to adapt to different diameters of the pulmonary vein, and in the working process, the diameter of the bearing frame 24 is adjusted to be increased so that the ablation element 25 passes through the pulmonary vein at the ostium to generate an electric field by transmitting pulse energy to ablate tissue, or the diameter of the bearing frame 24 is adjusted to be reduced so that the ablation element 25 is placed in the pulmonary vein to ablate tissue.

[0070] The ablation device 100 of the present application can also be delivered to a specific position of the heart in a percutaneous puncture manner to ablate the left atrial appendage other than the pulmonary vein, or to ablate a trigger focus (such as the superior vena cava, coronary sinus ostium) other than the pulmonary vein, so as to achieve the effect of electrical isolation.

[0071] The inner tube 54 is a hollow structure, and optionally, a measuring catheter 31 or a guide wire can be inserted into the inner cavity of the inner tube 54 for measurement or positioning.

[0072] Please refer to Figures 6 to 8 , the ablation device 100a provided by the second embodiment of the present application has a structure similar to that of the first embodiment, and the difference between the two is that the ablation assembly 20a in the second embodiment omits the connecting frame based on the first embodiment, so that the proximal end of the bearing frame 24a is directly connected to the distal end of the outer tube 52, that is, the proximal end of each bearing rod 241 is connected to the distal end of the outer tube 52. Specifically, the bearing frame 24a includes a plurality of bearing rods 241a arranged in the circumferential direction in sequence, the distal end of each bearing rod 241a is spaced apart and connected to the distal end of a different first branch rod 225 in the positioning frame 22, and the proximal end of the plurality of bearing rods 241a is combined together and connected to the distal end of the outer tube 52.

[0073] When the relative position relationship between the inner tube 54 and the outer tube 52 is adjusted to adjust the outer diameter size of the bearing frame 24a, due to the combination together between the adjacent support rods in the positioning frame 22 and the mutual constraint, the bearing rods 241a in the bearing frame 24a are more prone to deformation relative to the positioning frame 22, so that the bearing frame 24a is prone to obvious changes in radial and axial dimensions during the change of the ablation assembly 20a in the ablation diameter range, the positioning frame 22 is more prone to keep the mesh shape due to the mutual constraint of the first main rod 221 and the first support rod 225, the deformation ratio is small, and a better centering effect can be maintained. Avoid the problem that the positioning frame 22 is deformed too much during the adjustment of the diameter of the bearing frame 24a, and cannot be pressed between the inner walls of the pulmonary vein, resulting in the problem that the adjustment assembly 50 cannot be aligned around the pulmonary vein opening.

[0074] The plurality of bearing rods 241a of the bearing frame 24a are arranged in the circumferential direction of the inner tube 54, and in the embodiment, the plurality of bearing rods 241a are uniformly arranged in the circumferential direction of the inner tube 54; the bearing frame 24 has 3-8 bearing rods, and in the embodiment, the bearing frame 24 has 6 bearing rods.

[0075] As shown in Figure 9 Each bearing rod 241a is provided with a plurality of ablation elements 25 along the axial direction thereof, and in the embodiment, the ablation elements 25 are ablation electrodes, the polarities of the two adjacent ablation electrodes on the same bearing rod 241a are opposite, and the polarities of the adjacent ablation electrodes on the adjacent two bearing rods 241a are opposite; the plurality of ablation electrodes on the bearing frame 24a enclose a plurality of annular rings in the longitudinal axis direction of the inner tube 54, and the plurality of electrodes on each annular ring form an annular electric field. In the embodiment, each bearing rod 241a is provided with three ablation elements 25 along the axial direction thereof, and the bearing frame 24a is provided with three annular rings of electrodes, and in the fully released state, the three annular rings of electrodes include a first annular ring of electrodes 2501 close to the inner tube 54, a third annular ring of electrodes 2503 away from the inner tube 54, and a second annular ring of electrodes 2505 between the first annular ring of electrodes 2501 and the third annular ring of electrodes 2503; due to the mutual coupling of the adjacent electrodes in the first annular ring of electrodes to form electric fields, these electric fields superimpose to form a first annular electric field 252 in the form of a closed loop arranged in the axial direction; the adjacent electrodes in the second annular ring of electrodes are coupled to each other to form electric fields, and these electric fields superimpose to form a second annular electric field 253 in the form of a closed loop arranged in the axial direction; the adjacent electrodes in the third annular ring of electrodes are coupled to each other to form electric fields, and these electric fields superimpose to form a third annular electric field 255 in the form of a closed loop arranged in the axial direction.

[0076] Meanwhile, since the polarities of the adjacent ablation electrodes on each carrier rod 241a are opposite, when the pulsed electric field is formed, the adjacent ablation electrodes on each carrier rod 241a are coupled to each other to also form radial electric fields, i.e., a first radial electric field 256 and a second radial electric field 257. The electric fields generated by all the ablation electrodes of the entire carrier frame 24a are distributed in a mesh shape in the circumferential and radial directions. By adjusting the specific form of the carrier rod 241a, the ablation electrodes on the carrier rod 241a can form a 3D space electric field, or a volume electric field, in space, and the ablation range is large. Even if the axis of the inner tube 54 does not coincide with the axis of the pulmonary vein, within a certain offset range, continuous ring-shaped electrical isolation can be performed.

[0077] Please refer to Figures 10 to 13 The ablation device provided in the third embodiment of the present application has a structure similar to that of the second embodiment, and the difference lies in that the carrier rod 241b in the third embodiment is a spiral rod, and the proximal end and the distal end of the spiral rod are deflected by a preset angle in the circumferential direction. Preferably, the preset angle is in the range of 30 degrees to 70 degrees.

[0078] The twisting angles (i.e., the spiral angles) of each carrier rod 241b at different positions from the proximal end can be different. Specifically, the spiral angle of the carrier rod 241b at a position between the proximal end and the distal end is greater than the spiral angle of the carrier rod 241b at the proximal end or the distal end. That is, the spiral carrier rod 241b has the maximum spiral angle at a position between the proximal end and the distal end. In an embodiment, the spiral angle of the carrier rod 241b at a midpoint between the proximal end and the distal end is greater than the spiral angle of the carrier rod 241b at the proximal end or the distal end, and the spiral angle decreases from the midpoint to both sides. In a preferred embodiment, the spiral angles of the carrier rod 241b are symmetrically distributed at positions on both sides of the midpoint. Such a spiral distribution structure makes the ablation assembly 20b have better compliance and closely abut the ablation tissue region.

[0079] In the present embodiment, the spiral carrier rods 241b are uniformly distributed in the circumferential direction of the inner tube 54, and the number of the carrier rods 241b is 3-10. The overall shape of the carrier rods 241b in the cross-sectional plane passing through the axis is an ellipse, a circle, or any other symmetrical geometric shape. In the present embodiment, the carrier frame 24b includes six carrier rods 241b, and each carrier rod 241b is provided with three ablation members 25 spaced from each other along the axial direction thereof. Each ablation member 25 is an ablation electrode, such as Figure 13As shown, the carrier rod 241b includes a carrier segment 243 arranged adjacent to the distal end thereof, and the ablation member 25 is arranged on the carrier segment 243; specifically, the ablation member 25 is sleeved on the peripheral wall of the carrier segment 243. In this embodiment, the ablation member 25 is an ablation electrode, which is arranged in the carrier segment 243 adjacent to the distal end of the carrier rod 241b and conforms to the spiral shape of the carrier rod 241b. In this way, the distance between the ablation electrodes can be ensured to be not too close after the inner tube 54 is pulled, so as to avoid the generation of electric arc, and the ablation electrodes of the ablation assembly 20b can also be ensured to have good wall-adhesion and compliance with the atrial tissue.

[0080] In one embodiment, the ablation electrodes on each carrier rod 241b have the same polarity, are connected to the same wire, and have opposite polarity to the ablation electrodes on the adjacent carrier rod 241b.

[0081] Please refer to Figure 14 and Figure 15 , the ablation device provided by the fourth embodiment of the present application has a structure similar to that of the second embodiment, and the difference lies in that the carrier rod 241c in the fourth embodiment is a bent rod, which includes an extension segment 242 extending outward along the radial direction of the outer tube 52, and a carrier segment 243 connected between one end of the extension segment 242 away from the outer tube 52 and the positioning frame 22, and the included angle between the extension segment 242 and the carrier segment 243 ranges from greater than 0 degree to less than 90 degree. Preferably, the included angle between the extension segment 242 and the carrier segment 243 ranges from greater than 30 degree to less than 60 degree.

[0082] The carrier rods 241c are distributed at the circumferential positions of the outer tube 52, and the number of the carrier rods 241c is 3-10, which surround the carrier frame 24c in the form of a conical longitudinal section. In this embodiment, the carrier frame 24c includes six carrier rods 241c, and each carrier rod 241c is provided with three ablation members 25 spaced from each other along the axial direction of the carrier rod 241c; each ablation member 25 is an ablation electrode, which conforms to the shape of each carrier rod 241c and is arranged at the middle part and the opposite two end parts of the carrier segment 243.

[0083] When the ablation is performed on the position of the ostium of the pulmonary vein, the inner tube 54 is pulled to deform the carrier frame 24c, i.e., the axial dimension of the carrier frame 24c is reduced, and the included angle between the extension segment 242 and the carrier segment 243 of each carrier rod 241c is reduced, until the ablation electrodes of the ablation assembly 20c have good wall-adhesion and compliance with the atrial tissue.

[0084] Please refer to Figure 16 and Figure 17The structure of the ablation device provided in the fifth embodiment of the present invention is similar to that of the first embodiment, except that the positioning frame 22a in the fifth embodiment is a reverse-enclosed structure, that is, the distal part of the positioning frame 22a is connected to the inner tube 54 along the direction from the distal end to the proximal end; specifically, the distal end of each first main rod 221a extends beyond the distal end of the inner tube 54, and the end of the first main rod 221a extends from its distal end to the proximal end and connects to the inner tube 54. An ablation element 25 is provided on the positioning frame 22a, that is, the ablation element 25 is provided at the distal end of the positioning frame 22a, specifically, the ablation element 25 is provided on the side of the first main rod 221a facing away from the inner tube 54, preferably, at the distal end of the positioning frame 22a.

[0085] In this embodiment, the distal end of the first main rod 221a is clamped into the double-layer steel sleeve at the distal end of the inner tube 54. The first main rod 221a is bent into an arc shape at the distal end of the positioning frame 22a. This structure can avoid instrument damage to the atrial tissue caused by the protruding tip at the distal end of the positioning frame 22a, and better conform to the anatomical structure of the cardiac ablation area. This reverse wrapping structure can also be used for ablation treatment of patients with hypertrophic myocardial disease.

[0086] like Figure 17 As shown, after the support frame 24d is retracted into the outer tube 52, and the positioning frame 22a is exposed from the distal end of the outer tube 52, the positioning frame 22a is similar to a sphere. These ablation components 25 are used to perform point ablation (focal ablation) on the inside of the heart. That is, in this embodiment, the ablation component 20d can be used not only for annular ablation but also for focal ablation, thus increasing the new indications for the ablation component 20a and showing good application prospects.

[0087] In other modified embodiments, the ablation element 25 may also be located at the location with the largest radial dimension of the positioning frame 22a, thereby facilitating access to the target tissue area.

[0088] It should be noted that the specific technical solutions in the above embodiments are applicable to each other, and will not be elaborated here.

[0089] The above are the embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the embodiments of the present invention, and these improvements and modifications are also considered to be within the protection scope of the present invention.

Claims

1. An ablation device, characterized by, The ablation assembly comprises an ablation component and an adjusting component arranged at the proximal end of the ablation component, the adjusting component comprises an outer tube and an inner tube which both extend in the axial direction, the ablation component comprises a support framework and an ablation element arranged on the support framework, the support framework comprises a positioning frame and a bearing frame, the positioning frame is arranged at the distal end relative to the bearing frame, the distal end of the outer tube is connected to the proximal end of the bearing frame, the distal end of the inner tube is connected to the distal end of the positioning frame, the support framework is deformed in the process of moving the inner tube relative to the outer tube, the deformation ratio of the positioning frame in the axial direction is smaller than the deformation ratio of the bearing frame in the axial direction, the deformation ratio is the ratio of the size of the positioning frame and the bearing frame in the fully released state minus the size after deformation to the size in the fully released state; the bearing frame comprises a plurality of bearing rods, the plurality of bearing rods are arranged in the circumferential direction of the inner tube, the ablation element is arranged on the bearing rod, in the process of ablation, the positioning frame is used for inserting into the pulmonary vein, so that the bearing frame can form a closed annular ablation area at the mouth of the pulmonary vein; The positioning frame comprises a plurality of first main rods and a plurality of first branch rods, the plurality of first main rods are arranged in the circumferential direction of the inner tube, the distal end of each first main rod is connected to the inner tube, the proximal end of each first main rod is connected to a plurality of corresponding first branch rods, the distal end of each bearing rod is connected to a plurality of corresponding first branch rods, and the other end of the plurality of first branch rods connected to the same bearing rod is connected to different first main rods.

2. The ablation device of claim 1, wherein, The rigidity of the cutting rod or material wire of the positioning frame is greater than or equal to the rigidity of the cutting rod or material wire of the bearing frame.

3. The ablation device of claim 1, wherein, The deformation ratio of the positioning frame in the radial direction is smaller than the deformation ratio of the bearing frame in the radial direction.

4. The ablation device of claim 1, wherein, The outer tube is a hollow tube, the inner tube is arranged in the outer tube, and the axial dimension and the radial dimension of the support framework change in the process of moving the inner tube relative to the outer tube in the axial direction.

5. The ablation device of claim 4, wherein, In the process of moving the inner tube relative to the outer tube in the axial direction towards the proximal end, the axial dimension of the bearing frame decreases and the radial dimension increases; in the process of moving the inner tube relative to the outer tube in the axial direction towards the distal end, the axial dimension of the bearing frame increases and the radial dimension decreases.

6. The ablation device of claim 1, wherein, The support framework is at least one of a mesh structure, a rod structure or a frame structure made of elastic metal wire or elastic metal tube.

7. The ablation device of claim 6, wherein, The positioning frame and the bearing frame are both formed with mesh holes, and the opening area of the mesh holes in the positioning frame is smaller than the opening area of the mesh holes in the bearing frame.

8. The ablation device of claim 7, wherein, The diameter of the material wire of the positioning frame is greater than or equal to the diameter of the material wire of the bearing frame.

9. The ablation device of claim 1, wherein, The proximal end of each bearing rod is connected to the outer tube.

10. The ablation device of claim 1, wherein, The proximal end of each first main rod is connected to two corresponding first branch rods, the other end of the two first branch rods connected to the proximal end of each first main rod extends in a direction away from each other, and the proximal end of each first branch rod is combined with the proximal end of the adjacent first branch rod.

11. The ablation device of claim 1, wherein, Each first main rod is bent away from the inner tube at the intersection with the corresponding plurality of first sub-rod, each bearing rod is bent away from the inner tube at the middle part, and each bearing rod is bent towards the inner tube at the connection with the corresponding plurality of first sub-rod.

12. The ablation device of claim 1, wherein, The support framework further comprises a connecting frame connected between the bearing frame and the outer tube, and the connecting frame has a larger deformation ratio than the positioning frame during deformation.

13. The ablation device of claim 12, wherein, The connecting frame is formed with mesh holes, and the opening area of the mesh holes in the positioning frame is smaller than that of the mesh holes in the connecting frame.

14. The ablation device of claim 12, wherein, The connecting frame comprises a plurality of second main rods and a plurality of second sub-rod, the plurality of second main rods are arranged along the circumference of the outer tube, the proximal end of each second main rod is connected to the outer tube, and the distal end of each second main rod is connected to the corresponding plurality of second sub-rod, the bearing frame comprises a plurality of bearing rods arranged along the circumference of the inner tube, the proximal end of each bearing rod is connected to the corresponding plurality of second sub-rod, the other end of the plurality of second sub-rod connected to the same bearing rod is connected to different second main rods, and the distal end of each bearing rod is connected to the positioning frame.

15. The ablation device of claim 1, wherein, Each bearing rod is a spiral rod, and the proximal end and the distal end of the bearing rod are deflected by a preset angle in the circumferential direction.

16. The ablation device of claim 15, wherein, The spiral angle of the bearing rod at a position between the proximal end and the distal end is greater than the spiral angle at the proximal end or the distal end of the bearing rod.

17. The ablation device of claim 1, wherein, The distal end of each first main rod exceeds the distal end of the inner tube, and the end of the first main rod extends from the distal end to the proximal end to connect the inner tube.

18. The ablation device of claim 1, wherein, The positioning frame and / or the bearing frame are provided with at least one ablation element, and the ablation element is an ablation electrode.

19. The ablation device of claim 18, wherein, The bearing rod comprises a bearing segment arranged adjacent to the distal end, and the ablation electrode is arranged in the bearing segment.

20. The ablation device of claim 18, wherein, The ablation electrode ablates tissue using a pulse energy source, each bearing rod is provided with a plurality of ablation electrodes along the axial direction, the polarity of adjacent two ablation electrodes on the same bearing rod is opposite, and the polarity of adjacent ablation electrodes on adjacent two bearing rods is opposite.

21. The ablation device of claim 20, wherein, The plurality of ablation electrodes on the bearing frame form a plurality of annular rings in the circumferential direction, and the plurality of electrodes on each annular ring form an annular electric field.

22. An ablation system, comprising: The ablation device comprises a mapping device and an ablation device according to any one of claims 1-21, the inner tube is a hollow tube, the mapping device comprises a mapping catheter and a mapping electrode arranged at the distal end of the mapping catheter, the mapping catheter is inserted into the inner tube, and the mapping electrode extends from the distal end of the inner tube to detect an electrophysiological signal in a target tissue region by abutting against a tissue wall.

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