Ablation components, radiofrequency ablation catheters and manufacturing methods

Abstract

This application provides an ablation component, a radiofrequency ablation catheter, and a manufacturing method, belonging to the field of radiofrequency ablation technology. The ablation component includes a radially contractible and expandable cage-like stent and a first ablation electrode. Along the circumference of the cage-like stent, multiple spaced-apart support arms are included. Each support arm includes a main trunk and branches. The two ends of the main trunks respectively form the proximal and distal ends of the cage-like stent. One end of each branch is connected to the main trunk, and the other end is a free end. The first ablation electrode is disposed on a branch. When the cage-like stent is in a contracted state, the extension direction of the branches is parallel to the extension direction of the main trunk. When the cage-like stent is in an expanded state, the main trunk bends outward, and the first ablation electrode adheres to the vessel wall due to the elasticity of the branches. This ablation component features a small contracted size of the cage-like stent, a simple structure, and good wall adhesion of the ablation electrode.

Description

Technical Field

[0001] This application relates to the field of radiofrequency ablation technology, and more specifically, to an ablation component, a radiofrequency ablation catheter, and a manufacturing method thereof. Background Technology

[0002] Radiofrequency ablation technology is widely used in the medical field, and ablation components carrying multiple ablation electrodes can greatly improve radiofrequency efficiency. Ablating overactive renal artery sympathetic nerves via radiofrequency ablation is a typical method for treating refractory hypertension. This procedure uses a catheter equipped with radiofrequency ablation electrodes, accessed via the radial or femoral artery to reach the target ablation site and ablate the sympathetic nerves, thereby achieving the therapeutic effect of treating hypertension.

[0003] In renal artery radiofrequency ablation, maintaining stable adhesion of the radiofrequency ablation electrode to the vessel wall is crucial for forming a continuous ablation energy field. Good adhesion allows the radiofrequency energy input to penetrate the vessel wall as heat and reach the nerve to cause damage.

[0004] Currently, most ablation techniques use an electrode support, tip electrode, basket, and spiral wire structure as the energy carrier at the tip, which is deployed to a designated area for ablation through interventional surgery. However, the problem of poor electrode adhesion still exists. Summary of the Invention

[0005] This application provides an ablation component, a radiofrequency ablation catheter, and a manufacturing method. The cage-like stent has a small shrinkage size, a simple structure, and good wall adhesion of the ablation electrode.

[0006] In a first aspect, embodiments of this application provide an ablation assembly, which includes a radially contractible and expandable cage-like stent and a first ablation electrode. Along the circumference of the cage-like stent, the cage-like stent includes a plurality of spaced-apart support arms, each support arm including a main trunk and branches. The two ends of the plurality of main trunks respectively form the proximal and distal ends of the cage-like stent. One end of each branch is connected to the main trunk, and the other end is a free end. The first ablation electrode is disposed on the branch. When the cage-like stent is in a contracted state, the extension direction of the branch is parallel to the extension direction of the main trunk. When the cage-like stent is in an expanded state, the main trunk bends outward, and the first ablation electrode adheres to the blood vessel wall by the elastic force of the branch.

[0007] In this protocol, after the ablation component reaches the target vessel region via catheter, the cage-like stent, in its expanded state, expands outward and adheres to the vessel wall via multiple supporting arms. Due to the perforations on the cage-like stent, normal blood flow is allowed without obstruction, reducing the risk of unavoidable damage due to ischemia. The supporting arms include a main trunk and branches. One end of each branch connects to the main trunk, while the other end is free. When the cage-like stent is in its contracted state, the extension direction of the branches is parallel to that of the main trunk, making the cage-like stent approximately straight. Its small size allows it to reach the target vessel location with a relatively small outer diameter, meeting the requirements for transradial artery puncture. When the cage-like stent is in its expanded state, the main trunk bends outward and expands. Because the branches are connected to the main trunk, they bend outward along with it. The branches, with their free ends, further expand due to their rigidity. The first ablation electrode adheres to the vessel wall via the rebound force of the branches, resulting in better wall adhesion and a higher effective wall adhesion rate. Furthermore, after the cage-like support is attached to the wall, in addition to setting the first ablation electrode on the branch, an ablation electrode can also be set on the main body of the support arm. The cage-like support has more ablation electrode setting points, a wider range of ablation electrode positions, and a higher effective wall attachment rate.

[0008] In some embodiments, the branches and the trunk are formed as a single unit.

[0009] In the above technical solution, the branches and the main trunk are molded as one piece, which makes the structural stability of the support arm stronger.

[0010] In some embodiments, the support arm is made of shape memory alloy.

[0011] In the above technical solution, the support arm is made of shape memory alloy. By utilizing the superelasticity of shape memory alloy, the cage structure formed by the support arm has a small shrinkage size and a large expansion size, which can achieve effective adhesion of the ablation electrode on the cage support.

[0012] In some embodiments, the branch includes a first branch and a second branch, and a first ablation electrode is provided on both the first branch and the second branch.

[0013] In the above technical solution, both the first branch and the second branch are provided with first ablation electrodes. For the same main trunk, the number of first ablation electrodes is greater, which increases the ablation range of the ablation component and improves the ablation efficiency of the ablation component.

[0014] In some embodiments, the main trunk has a midpoint along its length; the connection point between the first branch and the main trunk is located between the proximal end and the midpoint, and the connection point between the second branch and the main trunk is located between the distal end and the midpoint; when the cage-like support is in a contracted state, the free end of the first branch points to the distal end, and the free end of the second branch points to the proximal end.

[0015] In the above technical solution, the connection point between the first branch and the main trunk is located between the proximal end and the midpoint, and the connection point between the second branch and the main trunk is located between the distal end and the midpoint. The free end of the first branch points to the distal end, and the free end of the second branch points to the proximal end. The first branch and the second branch are distributed in an intersecting manner. The positions of the first ablation electrodes on the first branch and the second branch can be staggered along the length of the main trunk. Therefore, the positions of the first ablation electrodes on the first branch and the second branch can be located on opposite sides of the midpoint of the main trunk, and the ablation range of the first ablation electrodes on the first branch and the second branch is wider.

[0016] In some embodiments, when the cage-like stent is in a retracted state, the free end of the first branch is located between the distal end and the midpoint, and the free end of the second branch is located between the proximal end and the midpoint.

[0017] In the above technical solution, since the area near the midpoint of the main trunk is where the bulge of the cage-like support is at its maximum, this area is conducive to the adhesion of the ablation electrode to the wall. Therefore, the free ends of the first branch and the second branch are located on opposite sides of the midpoint, meaning that the first branch and the second branch span across both sides of the midpoint of the main trunk. Along the length of the main trunk, the first branch and the second branch are longer, allowing for a wider range of optimal placement options for the first ablation electrode on the first branch and the wider ablation range of the first ablation electrode.

[0018] In some embodiments, the first branch and the second branch are located on opposite sides of the width direction of the trunk.

[0019] In the above technical solution, the first branch and the second branch are located on opposite sides of the main trunk in the width direction, and the first ablation electrodes on the first branch and the second branch are separated in the width direction. On the one hand, compared with the first branch and the second branch being located on the same side of the main trunk in the width direction, the probability of interference between the first ablation electrodes on the first branch and the second branch is reduced. On the other hand, the first ablation electrodes on the first branch and the second branch are staggered in both the length and width directions of the main trunk, resulting in a more reasonable distribution of the position of the first ablation electrodes, a wider range of selection, and a wider coverage area of ​​the first ablation electrodes on the first branch and the second branch, thereby increasing the ablation area of ​​the first ablation electrodes and reducing the probability of repeated ablation.

[0020] In some embodiments, the ablation assembly further includes a second ablation electrode disposed on the trunk.

[0021] In the above technical solution, by setting a second ablation electrode on the main body, the second ablation electrode can work with the first ablation electrode to complete the radiofrequency ablation of the target area. The support arm has more ablation electrode setting points and a wider ablation area, which improves the ablation efficiency of radiofrequency ablation.

[0022] In some embodiments, the number of trunks is set to three.

[0023] In the above technical solution, the number of main trunks is set to three. The cage-like stent composed of three main trunks has a relatively simple structure and is easy to implement, provided that the number of ablation is met.

[0024] In some embodiments, multiple main trunks are distributed at equal intervals along the circumference of the cage-like support.

[0025] In the above technical solution, multiple main branches are evenly distributed around the circumference of the cage-like support. On the one hand, the stress distribution of the cage-like support is more uniform, resulting in better structural stability. On the other hand, the distribution of ablation electrodes on the cage-like support is more uniform and reasonable, improving the uniformity of ablation and reducing the risk of excessively dense local ablation or repetitive efficiency.

[0026] Secondly, this application also provides a radiofrequency ablation catheter, which includes a tip, a catheter, a traction member, and an ablation component of any of the foregoing embodiments. The tip is connected to the distal end of multiple main trunks of a cage-like stent, and the catheter is connected to the proximal end of the cage-like stent. The catheter has a first cavity extending in the axial direction. The traction member is connected to the tip and is movably inserted through the first cavity and the cage-like stent. When the traction member moves from the distal end to the proximal end, the cage-like stent switches from a contracted state to an expanded state.

[0027] In the above technical solution, under the action of the traction component, the end can be pulled, thereby driving the cage-like support to complete the form switching between the contracted state and the expanded state, so that the ablation electrode on the cage-like support adheres to the wall and completes radiofrequency ablation. The operation is simple and quick, and only requires the action of the traction component.

[0028] Thirdly, this application also provides a method for manufacturing an ablation component, the method comprising the following steps: providing a tube or plate of shape memory metal material; cutting the tube to obtain a cage-like support with multiple support arms; or cutting the plate and then rolling it into a circle to obtain a cage-like support with multiple support arms; heat-setting the cage-like support to make the support arms of the cage-like support form an outward deformation trend.

[0029] In the above technical solution, the cage-like support is formed into multiple support arms by cutting sheet metal or tubing. The branching and main structure on the support arms facilitates the arrangement of ablation electrodes, resulting in a higher adhesion rate of the ablation electrodes to the wall. Furthermore, this processing technology is simple, lower in cost, easy to mass-produce, and highly efficient.

[0030] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0031] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 A schematic diagram of the cage-like stent in the radiofrequency ablation catheter in an expanded state, provided in some embodiments of this application;

[0033] Figure 2 for Figure 1 Enlarged diagram of A in the middle;

[0034] Figure 3 A front view of a cage-like stent in an expanded state in a radiofrequency ablation catheter provided for some embodiments of this application;

[0035] Figure 4 A schematic diagram of the cage-like stent in the radiofrequency ablation catheter in a contracted state, provided in some embodiments of this application;

[0036] Figure 5 This is a schematic diagram of the unconstrained structure of the branch of the radiofrequency ablation catheter cage stent provided in some embodiments of this application;

[0037] Figure 6 A schematic diagram of the cage-like support in a contracted state in some embodiments of the ablation assembly provided in this application;

[0038] Figure 7 for Figure 6 Enlarged diagram of B in the middle;

[0039] Figure 8 This is a front view of the cage-like support in the contracted state of the ablation assembly provided in some embodiments of this application.

[0040] Icons: 100-Ablation component; 10-Cage-shaped support; 11-Support arm; 111-Main trunk; 1111-Proximal end; 1112-Distal end; 1113-Midpoint; 112-Branch; 1121-First branch; 1122-Second branch; 20-First ablation electrode; 30-Second ablation electrode; 200-Radiofrequency ablation catheter; 201-End tip; 202-Catheter; 203-Traction element. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, 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. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0042] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0043] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0044] In the description of the embodiments of this application, it should be noted that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this application is usually placed during use. It is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on this application. In addition, the terms "first," "second," "third," etc. are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0045] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up" and "connected" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection 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.

[0046] In related technologies, radiofrequency ablation to ablate overactive renal artery sympathetic nerves is a typical method for treating refractory hypertension. This procedure uses a catheter with a radiofrequency electrode, accessed via the radial or femoral artery to reach the target ablation site and ablate the sympathetic nerves, thereby achieving the therapeutic effect of hypertension. The ablation electrode of the RDN product reaches the target ablation site to ablate the sympathetic nerves, thus achieving the therapeutic effect of hypertension. The ablation electrode can be attached to a supportive skeletal structure to adapt well to the blood vessel's course, ensuring good apposition performance, and meeting the requirements of radial artery puncture with minimal permeability—this is an important goal of this invention. For example, in the prior art, the spiral structure of RDN products is small in size and can enter the target blood vessel via radial artery puncture. However, its apposition to the blood vessel mainly relies on the rigidity of its own material, and the apposition force varies greatly for different blood vessel sizes; when the spiral structure enters the junction of the main trunk and branches of the blood vessel, there may be local electrodes that appose to the blood vessel wall, while other electrodes are left unsupported, which may still result in poor electrode apposition.

[0047] Therefore, this application provides an ablation component, please refer to... Figures 1 to 4 The ablation assembly 100 includes a radially contractible and expandable cage-like support 10 and a first ablation electrode 20. Along the circumference of the cage-like support 10, the cage-like support 10 includes a plurality of spaced-apart support arms 11. Each support arm 11 includes a main trunk 111 and branches 112. The two ends of the multiple main trunks 111 respectively form the proximal end 1111 and the distal end 1112 of the cage-like support 10. One end of each branch 112 is connected to the main trunk 111, and the other end is a free end. The first ablation electrode 20 is disposed on the branch 112. Figure 4 As shown, when the cage-like support 10 is in a retracted state, the extension direction of branch 112 is parallel to the extension direction of the main trunk 111; as Figure 1 and Figure 2 As shown, when the cage-like stent 10 is in an expanded state, the main trunk 111 bends outward, and the first ablation electrode 20 adheres to the blood vessel wall by the elastic force of the branch 112.

[0048] In this scheme, after the ablation component 100 reaches the target blood vessel area through the catheter 202, the cage-like stent 10, which is in an expanded state and has a cage-like structure, is stretched outward and abuts against the blood vessel wall by multiple support arms 11. Due to the perforated holes on the cage-like stent 10, blood can flow normally without obstructing blood flow, reducing the risk of unavoidable damage caused by ischemia. The support arms 11 include a main trunk 111 and branches 112. One end of the branch 112 is connected to the main trunk 111, and the other end is a free end. When the cage-like stent 10 is in a contracted state, the extension direction of the branch 112 is parallel to the extension direction of the main trunk 111. The cage-like stent 10 is approximately in a straight line. The cage-like stent 10 is small in size and can reach the target blood vessel position with a small outer diameter through the access device, which can meet the needs of transradial artery puncture. When the cage-like stent 10 is in the expanded state, the main trunk 111 bends and expands outward. Since the branch 112 is connected to the main trunk 111, the branch 112 bends outward along with the main trunk 111. The branch 112 has a free end, and it further expands due to its own rigidity. The first ablation electrode 20 adheres to the vessel wall due to the rebound force of the branch 112, resulting in better wall adhesion and a higher effective wall adhesion rate. Furthermore, after the cage-like stent 10 adheres to the wall, in addition to the first ablation electrode 20 on the branch 112, an ablation electrode can also be placed on the main trunk 111 of the support arm 11. This increases the number of ablation electrode placement points on the cage-like stent 10, expands the range of ablation electrode placement options, and further increases the effective wall adhesion rate.

[0049] The support arm 11 is made of a super-elastic material, such as nickel-titanium or cobalt-nickel. The number of support arms 11 can be two, three, four, etc., depending on the specific circumstances. For the same main trunk 111, the number of branches 112 can be one, two, or four, etc. The specific number of branches 112 can be determined based on the actual situation. Figure 1 As shown, for the same main branch 111, there are two branches 112. Figure 5 As shown, there is one branch 112. Furthermore, the number of first ablation electrodes 20 on branch 112 can be one or more. The number of first ablation electrodes 20 can be determined according to the actual situation.

[0050] The two ends of the multiple main branches 111 can be converged to form the proximal end 1111 and distal end 1112 of the cage-like support 10, respectively. Of course, one end of the multiple main branches 111 can be converged to form the end of the cage-like support 10, for example, in this embodiment, such as Figure 6 As shown, one end of each of the multiple main trunks 111 can be brought together to form the distal end 1112 of the cage-like support 10, and the proximal end 1111 of the cage-like support 10 is fixedly connected to the conduit 202.

[0051] The proximal end 1111 and distal end 1112 mentioned above are relative to the operator. The end of the cage-like support 10 closer to the operator is one end, and the end of the cage-like support 10 farther away from the operator is the distal end 1112.

[0052] It should be noted that after the radiofrequency ablation catheter 200 is loaded, as follows: Figure 1 and Figure 3 The expanded state of the cage-like stent 10 in the figure actually represents its position within the target vessel, with the main trunk 111 and branches 112 constrained by the vessel wall. If the cage-like stent 10 were in an expanded state externally, its orientation would be as follows: Figure 5 As shown, the free end of branch 112 is located outside the trunk 111.

[0053] After the cage-like stent 10 is delivered to the target blood vessel area via the ablation catheter 202, it is controlled to switch from a contracted state to an expanded state. The cage-like stent 10 expands outward and adheres to the blood vessel wall. The main branch 111 adheres to the wall, while the branch 112 adheres to the wall due to its own tension. The branch 112 is made of a softer material, and after touching the blood vessel wall, it forms the first ablation electrode 20 that adheres to the wall. To further reduce the risk of the branch 112 scratching the blood vessel, the free end of the branch 112 can be hemispherical, arc-shaped, or spherical, reducing the risk of damage to the blood vessel.

[0054] When it is necessary to move the cage-like support 10 to the next position for ablation, the cage-like support 10 is switched from the expanded state to the contracted state, and the cage-like support 10 is contracted into a straight line. After the cage-like support 10 is moved to the next position, it is expanded again to achieve radiofrequency ablation of the target position.

[0055] After the radiofrequency ablation catheter 200 is loaded, the proximal end 1111 of the support arm 11 is fixedly connected to the distal end 1112 of the catheter 202, and the distal end 1112 of the support arm 11 is fixedly connected to the end 201. The maximum bulge of the cage-like stent 10 is mainly located near the middle of the cage-like stent 10. When the cage-like stent 10 expands, the bulge curvature of the main trunk 111 is constrained by the axial ends of the support arm. Therefore, the outward expansion of the cage-like stent 10 is not only limited by the vessel wall, but may also be constrained by the axial ends of the cage-like stent 10 itself. Branch 112 is different. Branch 112 is attached to the main trunk 111 and has a free end. In addition to bending and expanding outward with the main trunk 111, branch 112 can also expand outward further due to its own rigidity, similar to an open umbrella. Branch 112 will only be constrained by the blood vessel wall and will stop expanding. Therefore, the first ablation electrode 20 on branch 112 has a higher adhesion rate.

[0056] In some embodiments, the branch 112 and the main trunk 111 are integrally formed. Integrating the branch 112 and the main trunk 111 into one piece enhances the structural stability of the support arm 11.

[0057] The integral molding of branch 112 and trunk 111 means that branch 112 and trunk 111 are a whole. In the actual manufacturing process, the support arm 11 can be formed by cutting and grooving to form trunk 111 and branch 112, which is simple to process.

[0058] In some embodiments, the support arm 11 is made of shape memory alloy. By using shape memory alloy as the material for the support arm 11, the superelasticity of the shape memory alloy allows the cage-like structure formed by the support arm 11 to have a small shrinkage size and a large expansion size, which can achieve effective adhesion of the ablation electrode on the cage-like support 10.

[0059] In some embodiments, please refer to Figure 1 and Figure 2 Branch 112 includes a first branch 1121 and a second branch 1122, both of which are provided with a first ablation electrode 20. The presence of more first ablation electrodes 20 on both branches increases the ablation range of the ablation assembly 100 and improves its ablation efficiency for the same main branch 111.

[0060] The first branch 1121 and the second branch 1122 can be located on the same side of the main trunk 111 in the width direction, or they can be located on opposite sides of the main trunk 111 in the width direction. The specific positions of the first branch 1121 and the second branch 1122 can be determined according to the actual situation.

[0061] The number of first ablation electrodes 20 on the first branch 1121 and the second branch 1122 can be one or more. Optionally, the number of first ablation electrodes 20 on the first branch 1121 and the second branch 1122 is one.

[0062] In some embodiments, such as Figure 6 and Figure 7As shown, along the length of the main trunk 111, the main trunk 111 has a midpoint 1113; the connection point between the first branch 1121 and the main trunk 111 is located between the proximal end 1111 and the midpoint 1113, and the connection point between the second branch 1122 and the main trunk 111 is located between the distal end 1112 and the midpoint 1113; when the cage-like support 10 is in a contracted state, the free end of the first branch 1121 points to the distal end 1112, and the free end of the second branch 1122 points to the proximal end 1111. The connection point between the first branch 1121 and the main trunk 111 is located between the proximal end 1111 and the midpoint 1113. The connection point between the second branch 1122 and the main trunk 111 is located between the distal end 1112 and the midpoint 1113. The free end of the first branch 1121 points towards the distal end 1112, and the free end of the second branch 1122 points towards the proximal end 1111. The first branch 1121 and the second branch 1122 are intersecting. The positions of the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 can be staggered along the length of the main trunk 111. Therefore, the positions of the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 can be located on opposite sides of the midpoint 1113 of the main trunk 111, resulting in a wider ablation range for the first ablation electrodes 20 on the first branch 1121 and the second branch 1122.

[0063] Midpoint 1113 refers to the location of the midpoint 1113 region along the length of the main trunk 111. With midpoint 1113 as the boundary, the lengths on both sides of midpoint 1113 of the main trunk 111 are the same.

[0064] In some embodiments, please combine Figure 6 , Figure 7 and Figure 8 When the cage-like stent 10 is in a contracted state, the free end of the first branch 1121 is located between the distal end 1112 and the midpoint 1113, and the free end of the second branch 1122 is located between the proximal end 1111 and the midpoint 1113. Since the area near the midpoint 1113 of the main trunk 111 is where the bulge of the cage-like stent 10 is at its maximum, this area is conducive to the adhesion of the ablation electrode to the wall. Therefore, the free ends of the first branch 1121 and the second branch 1122 are located on opposite sides of the midpoint 1113, that is, the first branch 1121 and the second branch 1122 span across the midpoint 1113 of the main trunk 111. Along the length of the main trunk 111, the first branch 1121 and the second branch 1122 are longer, and the optimal setting position of the first ablation electrode 20 on the first branch 1121 and the second branch 1122 can be selected within a wider range, and the ablation range of the first ablation electrode 20 is wider.

[0065] In some embodiments, such as Figure 7As shown, the first branch 1121 and the second branch 1122 are located on opposite sides of the width direction of the main trunk 111. By placing the first branch 1121 and the second branch 1122 on opposite sides of the width direction of the main trunk 111, and separating the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 in the width direction, the probability of interference between the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 is reduced compared to having the first branch 1121 and the second branch 1122 on the same side of the width direction of the main trunk 111. Furthermore, the staggered distribution of the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 in both the length and width directions of the main trunk 111 results in a more reasonable and wider range of positions for the first ablation electrodes 20. This increases the ablation area of ​​the first ablation electrodes 20 and reduces the probability of repeated ablation.

[0066] The width direction of the main trunk 111 refers to the length direction perpendicular to the main trunk 111, and the length direction of the main trunk 111 is the extension direction of the proximal end 1111 and the distal end 1112.

[0067] In some embodiments, the ablation assembly 100 further includes a second ablation electrode 30, which is disposed on the main shaft 111. By providing the second ablation electrode 30 on the main shaft 111, the second ablation electrode 30 can cooperate with the first ablation electrode 20 to complete radiofrequency ablation of the target area. The support arm has more ablation electrode placement points and a wider ablation area, thereby improving the ablation efficiency of radiofrequency ablation.

[0068] The second ablation electrode 30 may have the same structure as the first ablation electrode 20, or it may be different. The second ablation electrode 30 and the first ablation electrode 20 may have the same structure. The number of second ablation electrodes 30 on the main branch 111 may be one or more. In this embodiment, the number of second ablation electrodes 30 is one.

[0069] In some embodiments, the number of main trunks 111 is set to three. With three main trunks 111, the cage-like support 10 formed by the three main trunks 111 has a relatively simple structure and is easy to implement, provided that the ablation quantity is met.

[0070] In some embodiments, multiple main branches 111 are evenly spaced along the circumference of the cage-like support 10. Distributing the multiple main branches 111 at equal intervals along the circumference of the cage-like support 10 results in a more uniform stress distribution and better structural stability. Furthermore, it allows for a more uniform and rational distribution of ablation electrodes on the cage-like support 10, improving the uniformity of ablation and reducing the risk of overly dense local ablation or inefficient repetitive ablation.

[0071] This application also provides a radiofrequency ablation catheter 200, please refer to... Figures 1 to 4 The radiofrequency ablation catheter 200 includes a tip 201, a catheter 202, a traction member 203, and the ablation assembly 100 of any of the aforementioned embodiments. The tip 201 is connected to the distal end 1112 of the plurality of main trunks 111 of the cage-like support 10, and the catheter 202 is connected to the proximal end 1111 of the cage-like support 10. The catheter 202 has a first cavity extending in the axial direction. The traction member 203 is connected to the tip 201 and is movably inserted through the first cavity and the cage-like support 10. When the traction member 203 moves from the distal end 1112 to the proximal end 1111, the cage-like support 10 switches from a contracted state to an expanded state. Under the action of the traction member 203, the tip 201 can be pulled, thereby driving the cage-like support 10 to complete the shape switching between the contracted and expanded states, so that the ablation electrode on the cage-like support 10 adheres to the wall, completing radiofrequency ablation. The operation is simple and quick, requiring only the action of the traction member 203.

[0072] End 201 refers to the head structure of the distal end 1112 of the cage-like support 10. End 201 serves to fix and install the distal end 1112 of the cage-like support 10. End 201 can be conical or frustum-shaped. End 201 has an inner cavity into which the distal end 1112 of the cage-like support 10 can be inserted and connected. End 201 is smaller in size, which facilitates its insertion into access devices.

[0073] The catheter 202 has a first cavity through which the traction element 203 can be installed. Of course, the catheter 202 also has functional cavities, which can be one or more. The functional cavities are located on the outer periphery of the first cavity and can be used for the wiring of the ablation electrode and monitoring components.

[0074] The traction element 203 can be a traction wire or a traction tube. The distal end 1112 of the traction element 203 is connected to the end head 201, and the other end can be connected to a handle. The traction element 203 can switch the state of the cage-like support 10, allowing it to switch between a contracted state and an expanded state. Specifically, pulling the traction element 203 towards the proximal end 1111 causes the end head 201 to move towards the proximal end 1111 under the pulling force of the traction element 203, thereby causing the cage-like support 10 to bend and expand outwards, allowing it to switch from a contracted state to an expanded state. Pulling the traction element 203 towards the distal end 1112 causes the end head 201 to lose the pulling force of the traction element 203, and under the action of a restoring force, the end head 201 moves towards the distal end 1112, allowing the cage-like support 10 to switch from an expanded state to a contracted state.

[0075] This application also provides a method for manufacturing an ablation component, the method comprising the following steps: providing a tube or plate of shape memory metal material; please refer to Figure 6 , Figure 7 and Figure 8 The pipe is cut to obtain a cage-like support 10 with multiple support arms 11. Alternatively, the plate is cut and rolled into a circle to obtain a cage-like support 10 with multiple support arms 11; the cage-like support 10 is heat-set to make the support arms 11 of the cage-like support 10 deform outward.

[0076] The cage-like support 10 is formed into multiple support arms 11 by cutting sheet metal or tubing. The branch 112 and main trunk 111 on the support arms 11 facilitate the arrangement of ablation electrodes, resulting in a higher adhesion rate of the ablation electrodes to the wall. Moreover, this processing technology is simple, has lower cost, is easy to achieve mass production, and has high production efficiency.

[0077] Heat setting refers to pre-bending the cage-like support 10 so that the area near the middle of the support arm 11 has an outward bending range, that is, giving the support arm 11 a slight outward bulge or crease. In this way, when the traction member 203 pulls the cage-like support 10, the cage-like support 10 will bend and expand outward under the compressive force, instead of bending inward.

[0078] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0079] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An ablation component, characterized in that, include: A radially contractible and expandable cage-like support, along the circumference of the cage-like support, the cage-like support includes a plurality of spaced-apart support arms, each support arm including a main trunk and branches, the two ends of the plurality of main trunks respectively forming the proximal end and distal end of the cage-like support, one end of each branch being connected to the main trunk, and the other end being a free end; A first ablation electrode is disposed on the branch; When the cage-like stent is in a contracted state, the extension direction of the branch is parallel to the extension direction of the main trunk; when the cage-like stent is in an expanded state, the main trunk bends outward, and the first ablation electrode adheres to the blood vessel wall by the elastic force of the branch. The branch includes a first branch and a second branch, and the first ablation electrode is provided on both the first branch and the second branch; Along the length of the main trunk, the main trunk has a midpoint; The connection point between the first branch and the main trunk is located between the proximal end and the midpoint, and the connection point between the second branch and the main trunk is located between the distal end and the midpoint; When the cage-like support is in a retracted state, the free end of the first branch points towards the distal end, and the free end of the second branch points towards the proximal end.

2. The ablation component according to claim 1, characterized in that, The branch and the trunk are integrally formed.

3. The ablation component according to claim 1, characterized in that, The support arm is made of shape memory alloy.

4. The ablation component according to claim 1, characterized in that, When the cage-like support is in a retracted state, the free end of the first branch is located between the distal end and the midpoint, and the free end of the second branch is located between the proximal end and the midpoint.

5. The ablation component according to claim 1, characterized in that, The first branch and the second branch are located on opposite sides of the width direction of the main trunk.

6. The ablation component according to claim 1, characterized in that, The ablation component also includes: The second ablation electrode is disposed on the main trunk.

7. The ablation component according to claim 1, characterized in that, The number of main trunks is set to three.

8. The ablation component according to any one of claims 1-7, characterized in that, Along the circumference of the cage-like support, a plurality of the main trunks are distributed at equal intervals.

9. A radiofrequency ablation catheter, characterized in that, The device includes an end cap, a catheter, a traction element, and an ablation assembly according to any one of claims 1-8. The end cap is connected to the distal end of a plurality of the main trunks of the cage-like stent, the catheter is connected to the proximal end of the cage-like stent, and the catheter has a first cavity extending in an axial direction. The traction element is connected to the end cap and is movably disposed within the first cavity and the cage-like stent. When the traction element moves from the distal end to the proximal end, the cage-like stent switches from the contracted state to the expanded state.

10. A method for manufacturing an ablation component, based on the ablation component according to any one of claims 1-8, characterized in that, Includes the following steps: We provide tubes or sheets made of shape memory metal. The pipe is cut to obtain a cage-like support with multiple support arms; Alternatively, the plate can be cut and rolled into a circle to obtain a cage-like support with multiple support arms. The cage-like support is heat-set to cause the support arms on the cage-like support to deform outward.

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