Ablation assembly, radiofrequency ablation catheter and manufacturing method

Abstract

The embodiment of the invention provides an ablation assembly, a radiofrequency ablation catheter and a manufacturing method, and belongs to the technical field of radiofrequency ablation. The ablation assembly comprises a cage-shaped support capable of contracting and expanding in the radial direction and a first ablation electrode, the cage-shaped support comprises a plurality of supporting arms distributed at intervals in the circumferential direction of the cage-shaped support, each supporting arm comprises a trunk and a branch, the near end and the far end of the cage-shaped support are formed at the two ends of the trunks respectively, one end of each branch is connected with the corresponding trunk, and the other end of each branch is a free end. The first ablation electrode is arranged on the branch; when the cage-shaped bracket is in a contraction state, the extension direction of the branches is parallel to the extension direction of the trunk; when the cage-shaped support is in an expansion state, the trunk is bent outwards, and the first ablation electrode is attached to the blood vessel wall by means of resilience force of the branches. The cage-shaped support in the ablation assembly is small in shrinkage size and simple in structure, and the ablation electrode is good in wall attaching performance.

Description

Technical Field

[0001] The present application relates to the technical field of radiofrequency ablation, and in particular to an ablation component, a radiofrequency ablation catheter and a manufacturing method. Background Art

[0002] Radiofrequency ablation technology is widely used in the medical field. The ablation component carrying multiple ablation electrodes can greatly improve the radiofrequency efficiency. Ablation of overactive renal artery sympathetic nerves through radiofrequency ablation surgery is a typical method for treating refractory hypertension. This surgery can use a catheter with radiofrequency ablation electrodes to reach the ablation target location through the radial artery or femoral artery to ablate the sympathetic nerves, thereby achieving the effect of treating hypertension.

[0003] In renal artery radiofrequency ablation, keeping the radiofrequency ablation electrode stably attached to the wall is the key to forming a continuous ablation energy field. Good adhesion can maximize the amount of radiofrequency input energy in the form of heat that penetrates the blood vessel wall to reach the nerves and cause damage.

[0004] At present, most ablation technologies use electrode stents, head-end electrodes, baskets, and spiral wire structures as energy carriers at the head end, which are deployed to designated areas for ablation through interventional surgery. However, there is still the problem of poor electrode adhesion to the wall. Summary of the invention

[0005] The embodiments of the present application provide an ablation assembly, a radiofrequency ablation catheter, and a manufacturing method. The cage-shaped stent has a small shrinkage size, a simple structure, and good wall adhesion of the ablation electrode.

[0006] In the first aspect, an embodiment of the present application provides an ablation component, which includes a cage-shaped stent that can radially contract and expand and a first ablation electrode. Along the circumference of the cage-shaped stent, the cage-shaped stent includes a plurality of support arms distributed at intervals, the support arms include a trunk and branches, the two ends of the plurality of trunks respectively form the proximal end and the distal end of the cage-shaped stent, one end of the branch is connected to the trunk, and the other end is a free end; the first ablation electrode is arranged on the branch; when the cage-shaped stent is in a contracted state, the extension direction of the branch is parallel to the extension direction of the trunk; when the cage-shaped stent is in an expanded state, the trunk bends outward, and the first ablation electrode relies on the resilience of the branch to adhere to the blood vessel wall.

[0007] In this solution, after the ablation component reaches the target blood vessel area through the catheter, the cage-shaped stent in the expanded state is stretched outward and attached to the blood vessel wall through multiple support arms. Due to the hollow holes on the cage-shaped stent, blood can circulate normally without blocking blood flow, reducing the risk of inevitable damage caused by ischemia. The support arm includes a trunk and a branch, one end of the branch is connected to the trunk, and the other end is a free end. When the cage-shaped stent is in a contracted state, the extension direction of the branch is parallel to the extension direction of the trunk. The cage-shaped stent is approximately in a straight line. The size of the cage-shaped stent is small, and the cage-shaped stent can reach the target blood vessel position through the access device with a smaller outer diameter, which can meet the needs of radial artery puncture. When the cage-shaped stent is in an expanded state, the trunk bends outward and expands. Since the branch is connected to the trunk, the branch bends outward with the trunk, and the branch has a free end. The branch is further stretched by its own rigidity, and the first ablation electrode is attached to the blood vessel wall by the resilience of the branch, so that the first ablation electrode can better achieve wall adhesion, and the effective wall adhesion rate of the first ablation electrode is higher. Moreover, after the cage-shaped stent 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 trunk of the support arm. The number of setting points of the ablation electrode on the cage-shaped stent is greater, the range of selectable positions of the ablation electrode is wider, and the effective wall adhesion rate of the ablation electrode is higher.

[0008] In some embodiments, the branches and the trunk are integrally formed.

[0009] In the above technical solution, the branch and the trunk are formed in one piece, and the structural stability of the support arm is 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 the shape memory alloy, the cage-like structure formed by the support arm has a small contraction size and a large expansion size, thereby achieving effective wall adhesion of the ablation electrode on the cage-like stent.

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

[0013] In the above technical solution, first ablation electrodes are provided on both the first branch and the second branch. For the same 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 trunk has a midpoint along its length; the connection point between the first branch and the trunk is located between the proximal end and the midpoint, and the connection point between the second branch and the trunk is located between the distal end and the midpoint; when the cage-like stent 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 trunk is located between the proximal end and the midpoint, the connection point between the second branch and the trunk is located between the distal end and the midpoint, the free end of the first branch points to the distal end, the free end of the second branch points to the proximal end, the first branch and the second branch are cross-distributed, and the setting positions of the first ablation electrodes on the first branch and the second branch can be staggered in the length direction of the trunk. Then, the setting positions of the first ablation electrodes on the first branch and the second branch can be respectively located on opposite sides of the midpoint of the 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-shaped stent is in a collapsed 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 trunk is the position where the bulge of the cage-shaped support is the largest, this area is conducive to the ablation electrode sticking to the wall. Therefore, the free ends of the first branch and the second branch are respectively located on opposite sides of the midpoint, that is, the first branch and the second branch respectively span the two sides of the midpoint of the trunk, and along the length direction of the trunk, the length of the first branch and the second branch is longer, the optimal setting position of the first ablation electrode on the first branch and the second branch can be selected in a wider range, and the ablation range of the first ablation electrode is wider.

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

[0019] In the above technical solution, the first branch and the second branch are respectively located on opposite sides of the 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 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 the length direction and the width direction of the trunk, and the position distribution of the first ablation electrodes is more reasonable, with a larger selection range, and the corresponding first ablation electrodes on the first branch and the second branch have a wider coverage area, which increases the ablation area of ​​the first ablation electrode and reduces 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 arranging a second ablation electrode on the trunk, the second ablation electrode can cooperate with the first ablation electrode to complete radiofrequency ablation of the target area. The ablation electrodes on the support arm are arranged at more points, the ablation area is wider, and the ablation efficiency of radiofrequency ablation is improved.

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

[0023] In the above technical solution, the number of trunks is set to three. The cage-shaped stent formed by the three trunks has a relatively simple structure and is easy to implement while meeting the number of ablations.

[0024] In some embodiments, multiple trunks are evenly spaced along the circumference of the cage-shaped stent.

[0025] In the above technical solution, multiple trunks are evenly spaced around the cage-shaped stent. On the one hand, the force distribution of the cage-shaped stent is more uniform and the structural stability is good. On the other hand, the distribution of ablation electrodes on the cage-shaped stent is more uniform and reasonable, which improves the uniformity of ablation and reduces the risk of local ablation being too dense or repeated inefficiency.

[0026] In the second aspect, an embodiment of the present application also provides a radiofrequency ablation catheter, which includes a terminal, a catheter, a traction member, and an ablation assembly of any of the aforementioned embodiments, wherein the terminal is connected to the distal ends of multiple trunks of a cage-like stent, and the catheter is connected to the proximal end of the cage-like stent, and the catheter has a first lumen extending in an axial direction; the traction member is connected to the terminal, and the traction member can be movably disposed in the first lumen and the cage-like stent, and 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 member, the end can be pulled, thereby driving the cage-like stent to complete the morphological switching between the contracted state and the expanded state, so that the ablation electrode on the cage-like stent adheres to the wall to complete the radiofrequency ablation. The operation is simple and quick, and only the traction member needs to be acted on.

[0028] On the third aspect, an embodiment of the present application also provides a method for manufacturing an ablation component, the manufacturing method comprising the following steps: providing a tube or plate made of shape memory metal material; cutting the tube to obtain a cage-shaped stent with multiple support arms; or, cutting the plate and curling it into a circle to obtain a cage-shaped stent with multiple support arms; heat-setting the cage-shaped stent so that the support arms of the cage-shaped stent have an outward deformation tendency.

[0029] In the above technical solution, the cage-shaped stent is formed into multiple support arms by cutting a plate or a tube, and the arrangement of branches and trunks on the support arms is conducive to the arrangement of ablation electrodes, and the ablation electrodes have a higher wall adhesion rate. In addition, the processing technology is simple, the cost is lower, and it is easy to realize mass production with high production efficiency.

[0030] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0032] Figure 1 A schematic diagram of the structure of a cage-shaped stent in an expanded state in a radiofrequency ablation catheter provided in some embodiments of the present application;

[0033] Figure 2 for Figure 1 A is an enlarged schematic diagram;

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

[0035] Figure 4 A schematic diagram of the structure of a cage-shaped stent in a radiofrequency ablation catheter in some embodiments of the present application in a contracted state;

[0036] Figure 5 A schematic diagram of the structure of the branches of the cage-shaped stent of the radiofrequency ablation catheter provided in some embodiments of the present application without constraints;

[0037] Figure 6 A schematic diagram of the structure of a cage-shaped stent in a contracted state in an ablation assembly provided in some embodiments of the present application;

[0038] Figure 7 for Figure 6 A magnified schematic diagram of B;

[0039] Figure 8 A front view of a cage-shaped stent in an ablation assembly provided in some embodiments of the present application in a contracted state.

[0040] Icons: 100-ablation assembly; 10-cage support; 11-support arm; 111-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-RF ablation catheter; 201-tip; 202-catheter; 203-traction piece. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0042] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for which protection is sought, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0043] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0044] In the description of the embodiments of the present 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 the application is usually placed when in use, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0045] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be fixedly connected, detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0046] In the related art, radiofrequency ablation surgery to ablate overactive renal artery sympathetic nerves is a typical method for treating refractory hypertension. The surgery can use a catheter with a radiofrequency electrode to reach the ablation target position through the radial artery or femoral artery to ablate the sympathetic nerves, thereby achieving the effect of treating hypertension. The ablation electrode of the RDN product reaches the ablation target position to ablate the sympathetic nerves, thereby achieving the effect of treating hypertension. The ablation electrode can be attached to a supporting structural skeleton, which plays a good role in adapting to the shape of the blood vessel, ensuring good wall adhesion performance, and with a smaller passability, meeting the requirements of radial artery puncture is an important goal of this invention. For example, in the prior art, the spiral structure of the RDN product is small in size and can enter the target blood vessel position by radial artery puncture. However, its adhesion to the blood vessel mainly depends on the rigidity of its own material. For blood vessels of different sizes, its adhesion value varies greatly; when the spiral structure enters the junction of the main trunk and branch of the blood vessel, there will be a local electrode attached to the blood vessel wall, and other electrodes will be suspended, and there may still be a problem of poor electrode adhesion.

[0047] In view of this, the present application embodiment provides an ablation component, please refer to Figures 1 to 4 The ablation assembly 100 includes a cage-shaped stent 10 that can be radially contracted and expanded and a first ablation electrode 20. Along the circumference of the cage-shaped stent 10, the cage-shaped stent 10 includes a plurality of support arms 11 that are spaced apart. The support arms 11 include a trunk 111 and branches 112. The two ends of the plurality of trunks 111 respectively form a proximal end 1111 and a distal end 1112 of the cage-shaped stent 10. One end of the branch 112 is connected to the 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-shaped stent 10 is in a contracted state, the extension direction of the branch 112 is parallel to the extension direction of the trunk 111; Figure 1 and Figure 2 As shown, when the cage-shaped stent 10 is in an expanded state, the trunk 111 bends outward, and the first ablation electrode 20 is pressed against the blood vessel wall by the resilience of the branch 112 .

[0048] In this solution, after the ablation component 100 reaches the target blood vessel area through the catheter 202, the cage-shaped stent 10 in the expanded state is stretched outward and attached to the blood vessel wall through multiple support arms 11. Due to the hollow holes on the cage-shaped stent 10, blood can circulate normally without blocking blood flow, thereby reducing the risk of inevitable damage caused by ischemia. The support arm 11 includes a trunk 111 and a branch 112. One end of the branch 112 is connected to the trunk 111, and the other end is a free end. When the cage-shaped stent 10 is in a contracted state, the extension direction of the branch 112 is parallel to the extension direction of the trunk 111. The cage-shaped stent 10 is approximately in a straight line shape. The cage-shaped stent 10 is small in size. The cage-shaped stent 10 can reach the target blood vessel position through a passage device with a smaller outer diameter, which can meet the needs of radial artery puncture. When the cage-shaped stent 10 is in an expanded state, the trunk 111 bends and expands outwards. Since the branch 112 is connected to the trunk 111, the branch 112 bends outwards along with the trunk 111, and the branch 112 has a free end. The branch 112 further expands by relying on its own rigidity. The first ablation electrode 20 relies on the resilience of the branch 112 to adhere to the blood vessel wall, so that the first ablation electrode 20 can better adhere to the wall, and the effective wall adhesion rate of the first ablation electrode 20 is higher. Moreover, after the cage-shaped stent 10 adheres to the wall, in addition to the first ablation electrode 20 being set on the branch 112, the ablation electrode can also be set on the trunk 111 of the support arm 11. The number of setting points of the ablation electrode on the cage-shaped stent 10 is greater, the range of the position of the ablation electrode can be selected is larger, and the effective wall adhesion rate of the ablation electrode is higher.

[0049] The material of the support arm 11 is a superelastic material, for example, the material of the support arm 11 can be nickel titanium, cobalt nickel, etc. The number of the support arms 11 can be two, three, four, etc. The number of the support arms 11 is determined according to the actual situation. For the same trunk 111, the number of branches 112 can be one, two, or four, etc. The specific number of branches 112 can be determined according to the actual situation, such as Figure 1 As shown, for the same trunk 111, the number of branches 112 is two. Figure 5 As shown, the number of the branch 112 is one. In addition, the number of the first ablation electrode 20 on the branch 112 may be one or more. The number of the first ablation electrode 20 may be determined according to actual conditions.

[0050] The two ends of the plurality of trunks 111 can be gathered to form the proximal end 1111 and the distal end 1112 of the cage-shaped stent 10. Of course, one end of the plurality of trunks 111 can be gathered to form the end of the cage-shaped stent 10. For example, in this embodiment, Figure 6 As shown, one end of the plurality of trunks 111 can be gathered together to form a distal end 1112 of the cage-shaped stent 10 , and a proximal end 1111 of the cage-shaped stent 10 is fixedly connected to the catheter 202 .

[0051] The above-mentioned proximal end 1111 and distal end 1112 are relative to the operator. The end of the cage-shaped bracket 10 close to the operator is one end, and the end of the cage-shaped bracket 10 away from the operator is the distal end 1112.

[0052] It should be noted that after the radiofrequency ablation catheter 200 is loaded, Figure 1 and Figure 3 The expanded state of the cage-like stent 10 in the figure is actually the state of the cage-like stent 10 in the target blood vessel, and the trunk 111 and the branches 112 are constrained by the blood vessel wall. Figure 5 As shown, the free end of the branch 112 is located outside the trunk 111 .

[0053] After the cage-shaped stent 10 is delivered to the target blood vessel area following the ablation catheter 202, the cage-shaped stent 10 is controlled to switch from the contracted state to the expanded state, and the cage-shaped stent 10 expands outward and adheres to the blood vessel wall, the trunk 111 completes the wall adhesion, and the branch 112 adheres to the wall by its own tension. The material of the branch 112 is relatively soft, and the first ablation electrode 20 adheres to the wall after the branch 112 touches the blood vessel wall. In order to further reduce the risk of the branch 112 scratching the blood vessel, the shape of the free end of the branch 112 can be a hemispherical, arc-shaped or spherical structure, which reduces the risk of the branch 112 damaging the blood vessel.

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

[0055] After the RF ablation catheter 200 is loaded, the proximal end 1111 of the support arm 11 will be fixedly connected to the distal end 1112 of the catheter 202, and the distal end 1112 of the support arm 11 will be fixedly connected to the end 201, and the maximum bulge of the cage-shaped stent 10 is mainly located near the middle of the cage-shaped stent 10. When the cage-shaped stent 10 expands, the bulge of the main trunk 111 will be constrained by the axial ends of the support arm, so the outward expansion of the cage-shaped stent 10 may be constrained by the axial ends of the cage-shaped stent 10 in addition to the limitation of the blood vessel wall. The branch 112 is different. The branch 112 is attached to the trunk 111 and has a free end. In addition to bending and expanding outward with the trunk 111, the branch 112 can also further open outward due to its own rigidity, similar to an open umbrella. The branch 112 will only stop expanding due to the constraint of the blood vessel wall, so the first ablation electrode 20 on the branch 112 has a higher wall adhesion rate.

[0056] In some embodiments, the branch 112 is integrally formed with the trunk 111. By integrally forming the branch 112 with the trunk 111, the structural stability of the support arm 11 is enhanced.

[0057] The branch 112 and the trunk 111 are integrally formed, which means that the branch 112 and the trunk 111 are a whole. In the actual manufacturing process, the support arm 11 can be formed into the trunk 111 and the branch 112 by cutting and grooving, and the processing technology is simple.

[0058] In some embodiments, the support arm 11 is made of a shape memory alloy. By using the shape memory alloy as the material of the support arm 11 and utilizing the superelasticity of the shape memory alloy, the cage-like structure formed by the support arm 11 has a small contraction size and a large expansion size, so that the ablation electrode on the cage-like stent 10 can be effectively attached to the wall.

[0059] In some embodiments, please refer to Figure 1 and Figure 2 The branch 112 includes a first branch 1121 and a second branch 1122, and the first branch 1121 and the second branch 1122 are both provided with a first ablation electrode 20. The first branch 1121 and the second branch 1122 are both provided with a first ablation electrode 20. For the same trunk 111, the number of the first ablation electrodes 20 is greater, which increases the ablation range of the ablation assembly 100 and improves the ablation efficiency of the ablation assembly 100.

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

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

[0062] In some embodiments, Figure 6 and Figure 7As shown, along the length direction of the trunk 111, the trunk 111 has a midpoint 1113; the connection point between the first branch 1121 and the trunk 111 is located between the proximal end 1111 and the midpoint 1113, and the connection point between the second branch 1122 and the trunk 111 is located between the distal end 1112 and the midpoint 1113; when the cage-like stent 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 trunk 111 is located between the proximal end 1111 and the midpoint 1113, and the connection point between the second branch 1122 and the trunk 111 is located between the distal end 1112 and the midpoint 1113. 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 first branch 1121 and the second branch 1122 are cross-distributed, and the setting positions of the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 can be staggered in the length direction of the trunk 111. Then, the setting positions of the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 can be respectively located on opposite sides of the midpoint 1113 of the trunk 111, and the ablation range of the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 is wider.

[0063] The midpoint 1113 refers to the location of the midpoint 1113 region in the length direction of the trunk 111. With the midpoint 1113 as the boundary, the lengths of both sides of the midpoint 1113 of the trunk 111 are the same.

[0064] In some embodiments, please combine Figure 6 , Figure 7 and Figure 8 When the cage-shaped support 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 trunk 111 is the position where the bulge of the cage-shaped support 10 is the largest, this area is conducive to the ablation electrode sticking to the wall. Therefore, the free ends of the first branch 1121 and the second branch 1122 are respectively located on opposite sides of the midpoint 1113, that is, the first branch 1121 and the second branch 1122 are respectively across the midpoint 1113 of the trunk 111. Along the length direction of the trunk 111, the lengths of the first branch 1121 and the second branch 1122 are longer, the optimal setting position of the first ablation electrode 20 on the first branch 1121 and the second branch 1122 can be selected in a larger range, and the ablation range of the first ablation electrode 20 is wider.

[0065] In some embodiments, Figure 7As shown, the first branch 1121 and the second branch 1122 are respectively located on opposite sides of the width direction of the trunk 111. The first branch 1121 and the second branch 1122 are respectively located on opposite sides of the width direction of the trunk 111, and the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 are separated in the width direction. On the one hand, compared with the first branch 1121 and the second branch 1122 being located on the same side of the width direction of the trunk 111, the probability of interference between the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 is reduced. On the other hand, the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 are staggered in both the length direction and the width direction of the trunk 111, and the position distribution of the first ablation electrodes 20 is more reasonable, and the selection range is larger. Accordingly, the first ablation electrodes 20 on the first branch 1121 and the second branch 1122 cover a wider area, which increases the ablation area of ​​the first ablation electrode 20 and reduces the probability of repeated ablation.

[0066] The width direction of the trunk 111 refers to a direction perpendicular to the length direction of the trunk 111 , and the length direction of the trunk 111 is an 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 trunk 111. By disposing the second ablation electrode 30 on the trunk 111, the second ablation electrode 30 can cooperate with the first ablation electrode 20 to complete the radiofrequency ablation of the target area, and the ablation electrodes on the support arm are disposed at more points, and the ablation area is wider, thereby improving the ablation efficiency of radiofrequency ablation.

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

[0069] In some embodiments, the number of the trunks 111 is set to three. When the number of the trunks 111 is set to three, the cage-shaped stent 10 formed by the three trunks 111 has a relatively simple structure and is easy to implement while meeting the ablation quantity.

[0070] In some embodiments, multiple trunks 111 are evenly spaced along the circumference of the cage-shaped stent 10. The multiple trunks 111 are evenly spaced along the circumference of the cage-shaped stent 10. On the one hand, the force distribution of the cage-shaped stent 10 is more uniform, and the structural stability is good. On the other hand, the distribution of the ablation electrodes on the cage-shaped stent 10 is more uniform and reasonable, which improves the uniformity of ablation and reduces the risk of local ablation being too dense or repeated inefficiency.

[0071] The present application also provides a radiofrequency ablation catheter 200. Figures 1 to 4 The radiofrequency ablation catheter 200 includes a tip 201, a catheter 202, a traction member 203, and an ablation assembly 100 of any of the aforementioned embodiments. The tip 201 is connected to the distal ends 1112 of the multiple trunks 111 of the cage-shaped stent 10, and the catheter 202 is connected to the proximal end 1111 of the cage-shaped stent 10. The catheter 202 has a first lumen extending in the axial direction; the traction member 203 is connected to the tip 201, and the traction member 203 can be movably arranged in the first lumen and the cage-shaped stent 10. When the traction member 203 moves from the distal end 1112 to the proximal end 1111, the cage-shaped stent 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-shaped stent 10 to complete the morphological switching between the contracted state and the expanded state, so that the ablation electrode on the cage-shaped stent 10 is attached to the wall, and radiofrequency ablation is completed. The operation is simple and quick, and only the traction member 203 needs to be acted on.

[0072] The end 201 refers to the head structure of the distal end 1112 of the cage-like stent 10, and the end 201 can be used to fix the distal end 1112 of the cage-like stent 10. The end 201 can be a conical or truncated cone structure, and the end 201 has an inner cavity, and the distal end 1112 of the cage-like stent 10 can be inserted into the end 201 and connected to the end 201. The size of the end 201 is smaller, which is convenient for access instruments.

[0073] The catheter 202 has a first lumen, and the first lumen can be arranged to pass through the traction member 203. Of course, the catheter 202 also has a functional lumen, and the number of the functional lumens can be one or more, and the functional lumen is located on the outer peripheral side of the first lumen, and the functional lumen can be arranged to pass through the ablation electrode and the monitoring component.

[0074] The traction member 203 can be a traction wire or a traction tube. The distal end 1112 of the traction member 203 is connected to the end 201, and the other end can be connected to the handle. The traction member 203 can switch the state of the cage-like stent 10, so that the cage-like stent 10 can switch between a contracted state and an expanded state. Specifically, the traction member 203 is pulled to move in the direction of the proximal end 1111, and the end 201 is subjected to the pulling force of the traction member 203 and moves in the direction of the proximal end 1111, thereby driving the cage-like stent 10 to bend and expand outward, and the cage-like stent 10 can switch from a contracted state to an expanded state. The traction member 203 is pulled to move in the direction of the distal end 1112, and after the end 201 loses the pulling force of the traction member 203, the cage-like stent 10 moves in the direction of the distal end 1112 under the action of the reset force, and the cage-like stent 10 switches from an expanded state to a contracted state.

[0075] The present application also provides a method for manufacturing an ablation assembly, the method comprising the following steps: providing a tube or plate made of a shape memory metal material; Figure 6 , Figure 7 and Figure 8 , cutting the tube to obtain a cage-shaped bracket 10 having a plurality of support arms 11. Alternatively, cutting the plate and curling it into a circle to obtain a cage-shaped bracket 10 having a plurality of support arms 11; heat-setting the cage-shaped bracket 10 to make the support arms 11 of the cage-shaped bracket 10 form an outward deformation tendency.

[0076] The cage-shaped support 10 is cut into a plurality of support arms 11 by cutting a plate or a tube. The branches 112 and the trunk 111 on the support arms 11 are arranged to facilitate the arrangement of the ablation electrodes, and the ablation electrodes have a higher wall adhesion rate. The processing technology is simple, the cost is lower, and it is easy to realize mass production with high production efficiency.

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

[0078] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0079] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An ablation assembly, characterized in that: include: A cage-shaped stent that can be radially contracted and expanded, wherein along the circumference of the cage-shaped stent, the cage-shaped stent comprises a plurality of support arms distributed at intervals, the support arms comprising a trunk and branches, the two ends of the plurality of trunks respectively forming the proximal end and the distal end of the cage-shaped stent, one end of the branch is connected to the trunk, and the other end is a free end; A first ablation electrode is disposed on the branch; When the cage-shaped stent is in a contracted state, the extension direction of the branches is parallel to the extension direction of the trunk; when the cage-shaped stent is in an expanded state, the trunk bends outward, and the first ablation electrode is attached to the blood vessel wall by the resilience of the branches.

2. The ablation assembly according to claim 1, characterized in that: The branches and the trunk are integrally formed.

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

4. The ablation assembly according to claim 1, characterized in that: The branches include a first branch and a second branch, and the first ablation electrode is disposed on both the first branch and the second branch.

5. The ablation assembly according to claim 4, characterized in that: Along the length direction of the trunk, the trunk has a midpoint; The connection point between the first branch and the trunk is located between the proximal end and the midpoint, and the connection point between the second branch and the trunk is located between the distal end and the midpoint; When the cage-shaped stent 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.

6. The ablation assembly according to claim 5, characterized in that: When the cage-shaped stent is in a contracted 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.

7. The ablation assembly according to claim 4, characterized in that: The first branch and the second branch are respectively located at two opposite sides of the trunk in a width direction.

8. The ablation assembly according to claim 1, characterized in that: The ablation assembly further comprises: The second ablation electrode is arranged on the trunk.

9. The ablation assembly according to claim 1, characterized in that: The number of the trunks is set to three.

10. The ablation assembly according to any one of claims 1 to 9, characterized in that: Along the circumference of the cage-shaped support, a plurality of the trunks are distributed at equal intervals.

11. A radiofrequency ablation catheter, characterized in that: It includes an end tip, a catheter, a traction member and an ablation assembly according to any one of claims 1-10, wherein the end tip is connected to the distal ends of the plurality of 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 lumen extending in an axial direction; the traction member is connected to the end tip, and the traction member can be movably disposed in the first lumen and the cage-like stent, and when the traction member moves from the distal end to the proximal end, the cage-like stent switches from the contracted state to the expanded state.

12. A method for manufacturing an ablation component, based on the ablation component according to any one of claims 1 to 10, characterized in that: The following steps are involved: Providing tubes or sheets of shape memory metal materials; Cutting the tube to obtain a cage-shaped stent with a plurality of support arms; Alternatively, the plate is cut and then rolled into a circle to obtain a cage-shaped bracket having a plurality of support arms; The cage-shaped support is heat-set so that the support arms on the cage-shaped support have an outward deformation tendency.

Images