Ablation assembly and ablation catheter

Abstract

The embodiment of the utility model provides an ablation assembly and an ablation catheter, and belongs to the technical field of ablation. The ablation assembly comprises an electrode support capable of contracting and expanding in the radial direction, and the electrode support is made of shape memory alloy. Wherein the electrode support is in a spiral shape in the contraction state and the expansion state, and in the process of switching from the contraction state to the expansion state, the number of spiral turns of the electrode support is reduced, and the spiral diameter is increased. The electrode support after the ablation assembly is compressed is small in size and simple in structure, and has better shape restoration.

Description

Technical Field

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

[0002] Catheter ablation is used to treat various arrhythmias, tumors, hypertension, and diabetes. The ablation catheter plays a crucial role in the procedure, acting as a tool for energy transfer and targeting lesions.

[0003] Currently, most ablation techniques typically use a mesh-structured stent at the tip. When multiple ablation electrodes are arranged, the adhesion rate of the ablation electrodes to the wall is not high. The expansion state of the mesh stent is adjusted by pushing and pulling the central wire or by the contraction and expansion of the balloon. The structure of the electrode stent is relatively complex, requiring the intervention of a large-sized sheath, resulting in a high surgical risk. Furthermore, the structural stability of the electrode stent is not high, making it prone to failure. Utility Model Content

[0004] This application provides an ablation component and ablation catheter. The compressed electrode support is small in size, simple in structure, and has better morphological recovery.

[0005] In a first aspect, embodiments of this application provide an ablation component, which includes an electrode support that can radially shrink and expand. The electrode support is made of a shape memory alloy. The electrode support is helical in both the shrinking and expanding states. During the process of switching from the shrinking state to the expanding state, the number of helical turns of the electrode support decreases and the helical diameter increases.

[0006] In this solution, the electrode holder is made of shape memory alloy. Utilizing the shape memory effect of the alloy, temperature control allows for the switching between contraction and expansion states of the electrode holder. Compared to existing technologies using a central wire to deform the electrode holder or a balloon-like structure, the shape memory alloy electrode holder is simpler and smaller in size after compression. Furthermore, the electrode holder in this solution is helical in both contracted and expanded states. During the switching between these states, only the helical diameter and the number of turns change. Compared to existing shape memory alloy holders, the electrode holder in this solution exhibits less deformation during the shape switching process, resulting in superior shape recovery and a longer service life.

[0007] In some embodiments, the ablation assembly further includes an ablation electrode and a monitoring module, wherein the ablation electrode is disposed on an electrode support; the monitoring module is disposed on the electrode support and includes a pressure detection component and / or a temperature detection component.

[0008] In the above technical solution, the ablation electrode is mounted on an electrode support, and the ablation electrode achieves ablation of the target area by adhering to the vessel wall with the electrode support. The monitoring module includes a pressure detection component and / or a temperature detection component. The pressure detection component can detect the adhesion force between the electrode support and the vessel wall, ensuring good adhesion while guaranteeing the safety of the procedure and minimizing damage to the vessel; and / or, the temperature detection component is mainly used to monitor the temperature at the corresponding ablation point during the ablation process, ensuring precise ablation by the ablation components.

[0009] In some embodiments, the electrode support is formed by spirally wrapping strips.

[0010] In the above technical solution, the electrode support is formed by spiraling a strip. The electrode support processing technology is simple, low in cost, and easy to implement.

[0011] In some embodiments, the strip has multiple perforated holes.

[0012] In the above technical solution, by distributing multiple hollow holes on the strip, the rigidity of the strip is reduced, the deformation of the strip during the shape switching process is easier, the shape switching of the electrode support is smoother, and the reliability of the electrode support is high.

[0013] In some embodiments, the strip includes an end and multiple branches, one end of the multiple branches converges and connects to the end, and the other end of the multiple branches extends along the spiral direction of the electrode support; along the extension direction of the branches, adjacent branches alternately approach and separate from each other, and adjacent branches approach to form multiple nodes, at least one of the multiple nodes is used for mounting the ablation electrode and / or monitoring module, and adjacent branches and nodes enclose to form a hollow hole.

[0014] In the above technical solution, by dividing the strip into multiple branches, compared to a single sheet structure, the formation of multiple branches reduces the stiffness of the strip and improves the deformability of the electrode stent. With the same stiffness of the strip, the presence of branches allows for a larger contact area between the multiple branches and the vessel wall after the electrode stent is attached, providing better support. Furthermore, adjacent branches form multiple nodes, and the separation of adjacent branches with the nodes creates perforations, giving the spiral electrode stent a near-mesh structure characteristic, high redundancy, good deformability, and a small compressed size. Moreover, the dimensions at the nodes in the strip are larger than the width of a single branch, resulting in higher stability and facilitating the installation of the ablation electrode and / or monitoring module, ensuring the installation stability of the ablation electrode and / or monitoring module.

[0015] In some embodiments, a groove is provided on the node, and the ablation electrode and / or monitoring module are disposed in the groove.

[0016] In the above technical solution, by providing a groove on the node, the ablation electrode and / or monitoring module are disposed in the groove. On the one hand, the groove can accommodate at least part of the ablation electrode and / or monitoring module, thus reducing the size of the ablation assembly after the ablation electrode and / or monitoring module are installed in the groove of the node. On the other hand, the groove can limit the ablation electrode and / or monitoring module, making the installation stability of the ablation electrode and / or monitoring module on the electrode support higher.

[0017] In some embodiments, the branch has a wavy shape along its extension direction.

[0018] In the above technical solution, by adopting a wavy shape for the branches, the shape of the perforated holes on the strip is approximately elliptical, which avoids the formation of sharp ends on the strip, making the electrode stent less likely to scratch the blood vessel wall and improving its installability.

[0019] In some embodiments, the number of branches is four.

[0020] In the above technical solution, four branches are used. When the electrode support is attached to the wall, the four branches on the strip contact the blood vessel wall, resulting in a relatively larger contact area and better support for the blood vessel.

[0021] In some embodiments, a plurality of perforated holes are distributed at equal intervals along the length of the strip.

[0022] In the above technical solution, multiple hollow holes are evenly distributed along the length of the strip, making the deformation capacity of different areas on the strip more uniform and the electrode support less prone to excessive local stress.

[0023] In some embodiments, a groove is provided in the area between two adjacent perforations on the strip for embedding an ablation electrode and / or a monitoring module.

[0024] In the above technical solution, a groove is provided between two adjacent perforations on the strip-shaped component, and the ablation electrode and / or monitoring module are embedded in the groove. The groove can accommodate at least part of the ablation electrode and / or monitoring module, thus reducing the size of the ablation assembly after the ablation electrode and / or monitoring module are installed in the groove. Furthermore, the groove can limit the position of the ablation electrode and / or monitoring module, resulting in higher installation stability of the ablation electrode and / or monitoring module on the electrode support.

[0025] In some embodiments, the strip is made of a two-way memory alloy or a one-way memory alloy.

[0026] In the above technical solutions, the strip-shaped component is made of a two-way shape memory alloy. Utilizing the two-way shape memory principle, through training the shape memory metal, the ablation electrode on the expanded electrode stent can achieve adhesion to the vessel wall, with the phase transition temperature as the limit. Alternatively, the strip-shaped component can be made of a one-way shape memory alloy. Utilizing the superelasticity of shape memory alloys, the electrode stent is inserted into a designated position within the catheter. After the catheter is withdrawn, the electrode stent automatically springs open and adheres to the vessel wall.

[0027] In some embodiments, an insulating layer is provided on the outer surface of the strip.

[0028] In the above technical solution, by setting an insulating layer on the strip, the insulating layer plays an insulating role, and the electrode support will not short-circuit with the ablation electrode, monitoring module or heating wire, making the ablation component safer and more reliable to use.

[0029] In some embodiments, the ablation assembly further includes an ablation electrode disposed on an electrode support; the ablation electrode includes a first conductive layer, a first insulating layer, a second conductive layer, a second insulating layer, a third conductive layer, and a third insulating layer stacked sequentially, the first conductive layer constituting an electrode layer, the first conductive layer and the second conductive layer being made of different materials, the first conductive layer and the second conductive layer being provided with identical interconnecting blind holes, the first conductive layer and the second conductive layer being electrically connected through the blind holes, and the second insulating layer being an elastic compressible insulating layer.

[0030] In the above technical solution, the first conductive layer can be connected to the control circuit board of the device host (e.g., generator) via a wire. It forms a circuit with the neutral electrode attached to the patient's skin, allowing the first conductive layer to emit high-frequency alternating current into the vascular tissue, achieving denervation ablation of the ablation area. Because the first and second conductive layers are made of different materials, identical connecting blind holes are provided between them. The first and second conductive layers are electrically connected through these blind holes, forming a thermoelectric coupling at the blind hole location. The connection end of the second conductive layer is connected to the temperature module control circuit board of the device host (e.g., generator) via a wire of the same material, enabling temperature measurement of the ablation electrode. The third and second conductive layers can be connected to the control circuit board of the force sensing module of the device host. After the ablation electrode is attached to the wall, because the second insulating layer is an elastic compressible insulating layer, the third and second conductive layers form a capacitive pressure sensor, enabling pressure monitoring of the ablation electrode.

[0031] Secondly, embodiments of this application also provide an ablation catheter, which includes a catheter, a handle, and an ablation component of any of the foregoing embodiments. The ablation component is connected to the distal end of the catheter, and the handle is connected to the proximal end of the catheter.

[0032] In the above technical solution, the catheter is used to guide the ablation component. After the ablation component is delivered to the target location via the catheter, the handle controls the ablation component to extend outside the sheath or guiding tube. Heating or energizing is used to expand the electrode support, allowing the ablation electrode on the support to adhere to the wall, thus completing the ablation of the target area. The ablation component is then retracted into the sheath or guiding tube. After moving the sheath or guiding tube and the electrode support to the next ablation location, the handle is operated again to extend the ablation component outside the sheath or guiding tube. This process is repeated to complete the ablation of all designated areas.

[0033] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0034] 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.

[0035] Figure 1 This is a schematic diagram of the structure of the electrode support in the ablation assembly provided in some embodiments of this application;

[0036] Figure 2 This is a schematic diagram of the structure of the ablation assembly in the retracted state provided in some other embodiments of this application;

[0037] Figure 3 for Figure 2 Enlarged diagram of A in the middle;

[0038] Figure 4 for Figure 2 A schematic diagram of the middle electrode support from another angle;

[0039] Figure 5 for Figure 2 A schematic diagram of the structure of the middle electrode support at another angle;

[0040] Figure 6 This is a schematic diagram of the structure of the ablation assembly in an expanded state provided in some other embodiments of this application;

[0041] Figure 7 for Figure 6 Enlarged diagram of B in the diagram;

[0042] Figure 8 for Figure 6 A schematic diagram of the middle electrode support from another angle;

[0043] Figure 9 for Figure 6 A schematic diagram of the structure of the middle electrode support at another angle;

[0044] Figure 10 This is a schematic diagram of the structure of the ablation catheter provided in some embodiments of this application;

[0045] Figure 11 A schematic diagram of the electrode support in a contracted state in an ablation assembly provided in some embodiments of this application;

[0046] Figure 12 A schematic diagram of the electrode support in an expanded state in an ablation assembly provided in some embodiments of this application;

[0047] Figure 13 This is a partial schematic diagram of the ablation electrode mounted on the electrode support in some embodiments of the present application.

[0048] Figure 14 for Figure 13 Cross-sectional view of the ablation electrode.

[0049] Icons: 100-Ablation component; 10-Electrode support; 11-Strip; 111-End; 112-Secondary branch; 113-Branch; 114-Node; 115-Hole; 116-Groove; 20-Ablation electrode; 21-First conductive layer; 22-First insulating layer; 23-Second conductive layer; 24-Second insulating layer; 25-Third conductive layer; 26-Third insulating layer; 27-Blind hole; 200-Conduit; 300-Handle. Detailed Implementation

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] In related technologies, most ablation techniques typically use a mesh-structured scaffold at the tip. When multiple ablation electrodes are arranged, the electrode adhesion rate is not high. The expansion state of the mesh scaffold is adjusted by pushing and pulling the central wire or by the contraction and expansion of the balloon. The electrode scaffold structure is relatively complex, requiring the intervention of a large-sized sheath, resulting in a high surgical risk.

[0056] Of course, there are also support structures made of shape memory alloys, which utilize the shape memory properties of the alloys to achieve expansion and contraction between the electrodes. However, in the existing technology, the shape difference between the contracted and expanded states of shape memory alloy support structures is relatively large, resulting in relatively poor shape recovery and a relatively limited range of radial dimension changes.

[0057] Therefore, this application provides an ablation component, please refer to... Figures 1 to 14 The ablation assembly 100 includes an electrode support 10 that can radially shrink and expand. The electrode support 10 is made of shape memory alloy. The electrode support 10 is spiral in both the shrinking and expanding states. During the process of switching from the shrinking state to the expanding state, the number of spiral turns of the electrode support 10 decreases and the spiral diameter increases.

[0058] In this solution, the electrode support 10 is made of shape memory alloy. Utilizing the shape memory effect of the alloy, temperature control allows for the switching between contraction and expansion modes of the electrode support 10. Compared to existing technologies using a central wire to deform the electrode support 10 or a balloon-like support structure, the electrode support 10 made of shape memory alloy has a simpler structure and a smaller size after compression. Furthermore, please combine... Figure 2 and Figure 6 ,or Figure 11 and Figure 12 In this solution, the electrode support 10 is spiral in both the contracted and expanded states. During the shape switching process between the contracted and expanded states, only the spiral diameter and the number of spiral turns of the electrode support 10 change. Compared with the shape memory alloy support in the prior art, the electrode support 10 in this solution has a relatively small deformation during the two shape switching process, which makes the electrode support 10 have better shape recovery and a longer service life.

[0059] Understandably, since the electrode stent 10 only changes in the spiral diameter and the number of spiral turns, compared with the electrode stent 10 in the prior art, which is affected by the large difference in shape before and after deformation, the electrode stent 10 in this solution is spiral in both the contracted and expanded states. The electrode stent 10 has a relatively larger deformation range in diameter, which can be adapted to a larger range of blood vessel wall adhesion, and is conducive to the ablation electrode on the electrode stent 10 achieving a higher wall adhesion rate.

[0060] Shape memory alloys (SMA) are materials composed of two or more metallic elements that exhibit shape memory effect (SME) through thermoelastic and martensitic phase transformation and its inverse transformation.

[0061] Temperature conduction in the electrode holder 10 can be achieved through either electrical heating or thermal conduction, allowing the electrode holder 10 to switch to its phase transition temperature and control the temperature to achieve shape switching. For example, at least a portion of the electrode holder 10 near the conduit 200 can be wound with a heating wire. By energizing the heating wire, it heats up, and the heat is transferred to the electrode holder 10, causing it to reach its phase transition temperature. Alternatively, heat transfer can be used. A heat transfer wire is installed inside the conduit 200 and connected to the electrode holder 10. The heat transfer wire can be wound around at least a portion of the proximal end of the electrode holder 10. The handle at the front end of the conduit 200 can be heated or transferred to the electrode holder 10 via the heat transfer wire, similarly achieving deformation of the electrode holder 10. The main improvement in this solution lies in the structural modification of the electrode holder 10 itself. Further details on the heat transfer or heating structure of the electrode holder 10 will not be provided here. Technicians can achieve shape switching of the electrode holder 10 using the two methods described above.

[0062] The following embodiments are described in a non-limiting manner based on radiofrequency ablation. Those skilled in the art will understand that the following descriptions are merely exemplary, and similarly, the ablation catheter provided in this application can be adapted to other ablation scenarios such as ultrasound ablation, laser ablation, cryoablation, and chemical ablation after being adapted based on the application scenario.

[0063] In some embodiments, please refer to Figure 1 , Figure 2 and Figure 3 The ablation assembly 100 also includes an ablation electrode 20 and a monitoring module. The ablation electrode 20 is mounted on the electrode support 10. The monitoring module, also mounted on the electrode support 10, includes a pressure detection component and / or a temperature detection component. The ablation electrode 20, mounted on the electrode support 10, ablates the target area after adhering to the vessel wall. The monitoring module includes a pressure detection component and / or a temperature detection component. The pressure detection component detects the adhesion force between the electrode support 10 and the vessel wall, ensuring good adhesion while guaranteeing surgical safety and minimizing damage to the vessel. The temperature detection component primarily monitors the temperature at the corresponding ablation point during the ablation process, ensuring precise ablation by the ablation assembly.

[0064] On the electrode holder 10, the monitoring module and the ablation electrode 20 can be positioned adjacent to each other. That is, the pressure detection component and / or temperature detection component in the monitoring module are positioned close to the ablation electrode 20. This allows the monitoring module to accurately detect the adhesion force of the ablation electrode and the temperature at the ablation point. Alternatively, the monitoring module and the ablation electrode 20 can be integrally formed, meaning the monitoring module and the ablation electrode 20 are integrated. The ablation electrode 20 can then perform both ablation and temperature and / or pressure monitoring functions.

[0065] The pressure detection component can be a pressure sensor, which is a device or apparatus that can sense pressure signals and convert them into usable electrical output signals according to a certain rule. A pressure sensor typically consists of a pressure-sensitive element and a signal processing unit. The temperature detection component can be a temperature sensor or a thermocouple, enabling real-time monitoring of the temperature of the ablation zone.

[0066] In some embodiments, please refer to Figure 1 The electrode support 10 is formed by spirally winding a strip 11. The electrode support 10 is formed by spirally winding the strip 11, resulting in a simple, low-cost, and easily achievable manufacturing process. Multiple ablation electrodes 20 are spaced apart on the electrode support 10 along its extension direction.

[0067] In some embodiments, please refer to Figure 2 , Figure 4 , Figure 11 and Figure 12 The strip 11 has multiple perforated holes 115 distributed on it. By distributing multiple perforated holes 115 on the strip 11, the rigidity of the strip 11 is reduced, making it easier for the strip 11 to deform during shape switching, and the shape switching of the electrode support 10 is smoother, resulting in high reliability of the electrode support 10.

[0068] The perforated hole 115 refers to the hole structure distributed on the strip 11, which extends through the thickness direction of the strip 11. The perforated hole 115 can have various shapes, such as circular, square, parallelogram, or other irregular shapes, depending on the specific circumstances.

[0069] In some embodiments, please refer to Figures 2 to 8 The strip 11 includes an end 111 and multiple branches 113. One end of each branch 113 converges and connects to the end 111, and the other ends of each branch 113 extend along the spiral direction of the electrode support 10. Along the extension direction of the branches 113, adjacent branches 113 alternately approach and separate from each other. Adjacent branches 113 approach to form multiple nodes 114. At least one of the nodes 114 is used for mounting the ablation electrode 20 and / or the monitoring module. Adjacent branches 113 and nodes 114 enclose to form a perforated hole 115. By dividing the strip 11 into multiple branches 113, compared to a single sheet structure, the formation of multiple branches 113 can reduce the stiffness of the strip 11 and improve the deformability of the electrode support 10. With the same stiffness as the strip 11, the presence of branches 113 allows for a larger contact area between the multiple branches 113 and the vessel wall after the electrode support 10 is attached to the wall, providing better support for the vessel wall. Furthermore, adjacent branches 113 form multiple nodes 114, and adjacent branches 113 separate and enclose the nodes 114 to form perforated holes 115. This gives the spiral electrode support 10 a near-mesh structure, high redundancy, good deformability, and a small compressed size. Moreover, the dimensions at the nodes 114 in the strip 11 are larger than the width of a single branch 113, resulting in higher stability and facilitating the installation of the ablation electrode 20 and / or monitoring module, ensuring the installation stability of the ablation electrode and / or monitoring module.

[0070] The multiple branches 113 on the strip 11 are formed by cutting grooves into the strip 11. These branches 113 are created by cutting and carving into the strip 11, with one end of the strip 11 remaining ungrooved, forming an end portion 111. The number of branches 113 can be two, three, four, or five, etc. The number of branches 113 can be determined according to the specific circumstances. Please refer to [reference needed]. Figure 3 Node 114 refers to the common part formed by the intersection of two branches 113, and node 114 connects the two branches 113 locally into one.

[0071] The alternating approach and separation of two adjacent branches 113 means that each of the two branches 113 extends along the spiral direction of the strip 11, and the two branches 113 converge to form a node 114 after approaching each other. Then the two branches 113 separate and move away from each other, and then converge to form a node 114 again, and so on.

[0072] In some embodiments, please refer to Figure 6 and Figure 7 A groove 116 is provided on node 114, and the ablation electrode 20 and / or monitoring module are disposed in the groove 116. By providing the groove 116 on node 114 and disposing of the ablation electrode 20 and / or monitoring module in the groove 116, on the one hand, the groove 116 can accommodate at least part of the ablation electrode 20 and / or monitoring module, thus reducing the size of the ablation assembly 100 after the ablation electrode 20 and / or monitoring module are installed in the groove 116 of node 114. On the other hand, the groove 116 can limit the ablation electrode 20 and / or monitoring module, making the installation stability of the ablation electrode 20 and / or monitoring module on the electrode support 10 higher.

[0073] The groove 116 can be a blind hole, or it can be a through hole, depending on the specific situation. The ablation electrode 20 and / or monitoring module being disposed in the groove 116 means that one groove 116 can accommodate one ablation electrode 20, or one groove 116 can accommodate both the ablation electrode 20 and the monitoring module. In this embodiment, the monitoring module and the ablation electrode 20 are an integrated structure, with the ablation electrode 20 installed within the groove 116. Alternatively, the monitoring module and the ablation electrode 20 can be separate structures, with the two grooves 116 for installing the ablation electrode 20 and the monitoring module arranged adjacent to each other.

[0074] Please refer to Figure 7When the ablation electrode 20 is installed in the groove 116, a portion of the ablation electrode 20 protrudes from the groove 116, meaning the ablation electrode 20 protrudes from the outside of the electrode support 10, facilitating contact between the ablation electrode 20 and the blood vessel wall. Similarly, when the monitoring module is installed in the groove 116, the monitoring module can also protrude from the groove 116, meaning the monitoring module protrudes from the outside of the electrode support 10, facilitating contact between the monitoring module and the blood vessel wall, and enabling better monitoring of the temperature and pressure in the ablation area.

[0075] In addition, there are various ways to install the ablation electrode 20 and the monitoring module in the groove 116. The ablation electrode 20 and the groove 116 can be fixed by interference fit, ultrasonic welding or adhesive.

[0076] In some embodiments, please refer to Figures 2 to 9 Along the extension direction of branch 113, the line shape of branch 113 is wavy. By adopting a wavy shape for branch 113, the shape of the perforated hole 115 on the strip 11 is approximately elliptical, which avoids the formation of sharp ends 111 on the strip 11, making it less likely for the electrode support 10 to scratch the blood vessel wall and improving its installability.

[0077] In some embodiments, the number of branches 113 is four. By using four branches 113, when the electrode support 10 is attached to the wall, the four branches 113 on the strip 11 come into contact with the blood vessel wall, resulting in a relatively larger contact area and better support for the blood vessel.

[0078] In this embodiment, please continue to refer to Figure 2 and Figure 6 The strip 11 also includes a secondary branch 112, which is located between the end 111 and the branch 113. When there are four branches 113, there are two secondary branches 112. The ends of the two secondary branches 112 that are away from the branch 113 converge to form the end 111, and the other ends of the two secondary branches 112 are respectively connected to one end of the two branches 113. The secondary branch 112 serves as a transition, making the electrode support 10 smoother.

[0079] In some embodiments, please refer to Figure 11 and Figure 12 Multiple perforated holes 115 are evenly distributed along the length of the strip 11. This even distribution of the perforated holes 115 along the length of the strip 11 makes the deformation capacity of different areas on the strip 11 more uniform, thus preventing excessive local stress in the electrode support 10.

[0080] The shape of the perforated hole 115 can be at least one of a parallelogram, square, circle, or triangle. Please refer to... Figure 10 and Figure 11In this embodiment, the shape of the perforated hole 115 is a parallelogram.

[0081] In some embodiments, a groove is provided in the area between two adjacent perforations 115 on the strip 11 for embedding the ablation electrode 20 and / or monitoring module. By providing a groove between two adjacent perforations 115 on the strip 11, the ablation electrode 20 and / or monitoring module are embedded in the groove. The groove 116 can accommodate at least a portion of the ablation electrode 20 and / or monitoring module, thus reducing the size of the ablation assembly 100 after the ablation electrode 20 and / or monitoring module are installed in the groove. Furthermore, the groove 116 can limit the position of the ablation electrode 20 and / or monitoring module, resulting in higher installation stability of the ablation electrode 20 and / or monitoring module on the electrode support 10.

[0082] In some embodiments, the strip 11 is made of a two-way shape memory alloy or a one-way shape memory alloy. When the strip 11 is made of a two-way shape memory alloy, the principle of two-way shape memory is utilized. Through training the shape memory metal, the ablation electrode on the expanded electrode holder 10 can achieve adhesion to the vessel wall, with the phase transition temperature as the limit. When the strip 11 is made of a one-way shape memory alloy, the shape memory properties and superelasticity of the alloy are utilized. The electrode holder 10 is inserted into the designated position along with the catheter 200. Using a handle, the ablation component 100 extends out of the sheath or guiding catheter, and the electrode holder 10 automatically springs open, adhering to the vessel wall.

[0083] Specifically, taking the shape memory alloy of strip 11 as a two-way shape memory alloy as an example, the shape memory metal is trained to achieve state one when heated and return to its original state zero when cooled. Heat is transferred to the electrode support 10, which can be achieved through methods including but not limited to electricity and thermal conduction. After heating the electrode support 10 to the phase transition temperature, the structure of the electrode support 10 made of two-way shape memory metal changes. It expands along the diameter direction, with the diameter increasing from A to B. The electrode support 10 contracts axially, with its axial length decreasing. At this time, the ablation electrode on the outer surface of the electrode support 10 can adhere to the blood vessel wall within the diameter range D1-D2. After ablation of all points is completed, the temperature of the electrode support 10 is adjusted to drop below the phase transition temperature. The two-way shape memory metal returns to its original shape, with the diameter returning from B to A. The electrode support 10 contracts along the diameter direction, with its diameter decreasing, and extends axially, with its length increasing. At this time, the ablation electrode on the outer surface of the electrode support 10 can adhere to the blood vessel wall within the diameter range D0-D1. Wherein, DO < D1 < D2, for example, 3mm ≤ D0 < 5mm, 5mm ≤ D1 < 8mm, 8mm ≤ D2 < 12mm. By utilizing the temperature control function of the handle, the electrode stent 10 can present two different expansion states in the blood vessel to ensure the adhesion of the electrode stent 10 to the blood vessel wall.

[0084] A single-pass shape memory alloy electrode stent 10 can also be used, eliminating the need for temperature control. The phase transition temperature of the electrode stent 10 is set to the body fluid temperature. Once placed inside the body, the electrode stent 10 automatically expands without requiring further temperature control. The electrode stent 10 is inserted into the designated location via the catheter 200. Using a handle, the ablation component 100 extends out of the sheath or guiding catheter, and the spiral-shaped electrode stent 10 automatically springs open, conforming to the blood vessel wall. When the position of the electrode stent 10 needs to be moved, the ablation component 100 retracts into the sheath or guiding catheter. After moving the sheath or guiding catheter and the ablation component 100 to the next ablation location, the electrode stent 10 extends to perform ablation.

[0085] In some embodiments, an insulating layer is provided on the outer surface of the strip 11. By providing an insulating layer on the strip 11, the insulating layer serves as insulation, preventing short circuits between the electrode support 10 and the ablation electrode 20, monitoring module, or heating wire, making the ablation assembly 100 safer and more reliable to use.

[0086] An insulation layer is a layer of material used in electrical equipment to isolate electrical components from the casing or other components. Its main function is to prevent short circuits or leakage of current in electrical equipment.

[0087] In some embodiments, please refer to Figure 13 and Figure 14 The ablation assembly 100 also includes an ablation electrode 20, which is disposed on the electrode support 10. The ablation electrode 20 includes a first conductive layer 21, a first insulating layer 22, a second conductive layer 23, a second insulating layer 24, a third conductive layer 25, and a third insulating layer 26 stacked in sequence. The first conductive layer 21 constitutes the electrode layer. The first conductive layer 21 and the second conductive layer 23 are made of different materials. A blind hole 27 with the same connection is provided between the first conductive layer 21 and the second conductive layer 23. The first conductive layer 21 and the second conductive layer 23 are electrically connected through the blind hole 27. The second insulating layer 24 is an elastic compressible insulating layer.

[0088] The first conductive layer 21 can be connected to the control circuit board of the device host (e.g., generator) via a wire. It forms a circuit with the neutral electrode attached to the patient's skin, allowing the first conductive layer 21 to emit high-frequency alternating current into the vascular tissue, thereby achieving denervation ablation of the ablation area. Since the first conductive layer 21 and the second conductive layer 23 are made of different materials, the first conductive layer 21 and the second conductive layer 23 are provided with the same connected blind hole 27. The first conductive layer 21 and the second conductive layer 23 are electrically connected through the blind hole 27, thereby forming a thermoelectric coupling between the first conductive layer 21 and the second conductive layer 23 at the blind hole 27. The connection end of the second conductive layer 23 is connected to the temperature module control circuit board of the ablation device host (e.g., generator) via a wire of the same material, thereby realizing the temperature measurement function of the ablation electrode 20. The third conductive layer 25 and the second conductive layer 23 can be connected to the control circuit board of the force sensing module of the main unit of the device. After the ablation electrode 20 is attached to the wall, since the second insulating layer 24 is an elastic compressible insulating layer, the third conductive layer 25 and the second conductive layer 23 form a capacitive pressure sensor to realize pressure monitoring of the ablation electrode 20.

[0089] The second insulating layer 24 is an elastic compressible insulating layer. The second insulating layer 24 can be, but is not limited to, organosilicon elastomers, PU, ​​and TPU with microporous structures (morphologically, such as columnar, pyramidal, honeycomb, multi-cavity, etc.).

[0090] The third insulating layer 26 is a polymer material, which can be, but is not limited to, PI, PET, PU, ​​fluoropolymers, etc.

[0091] The second conductive layer 23 is a thin film of a metal conductor, such as constantan or copper, made of a different material than the first conductive layer 21. The first conductive layer 21 and the second conductive layer 23 are electrically connected through a blind via 27. The surface of the blind via 27 is electroplated with the same metal material as the first conductive layer 21, so that the first conductive layer 21 and the second conductive layer 23 form a thermoelectric coupling at this point. The connection end of the second conductive layer 23 is connected to the temperature module control circuit board of the device host (e.g., a generator) through a wire of the same material. When the first conductive layer 21 and the second conductive layer 23 form a circuit, due to the different materials of the first conductive layer 21 and the second conductive layer 23, the thermoelectric coupling is in a high-temperature environment at one end and a low-temperature environment at the other end. An electromotive force proportional to the temperature difference is generated in the circuit. The device host (e.g., a generator) measures the electromotive force and converts it into temperature to monitor the temperature of the ablation area. This combination forms a temperature sensor.

[0092] The temperature sensor's conditioning circuit implements the logic for temperature measurement. The main unit of the device has a temperature conditioning circuit, which mainly consists of an operational amplifier and a filter circuit. It amplifies the electromotive force across the thermocouple signal through filtering, converts it into an analog signal, and sends it to the ABC circuit. This is then converted into a digital signal, which the CPU can then process in software to calculate the current actual operating temperature.

[0093] The third conductive layer 25 is a metal thin film with excellent conductivity, such as a copper foil film; the third conductive layer 25 can also be a conductive composite material film. The composite material can be a combination of organosilicon or polymer materials and conductive materials. The polymer materials can be materials with good mechanical properties and flexibility, such as PU, TPU, PI, PEN, PET, etc. The conductive materials can be carbon-based materials (carbon black, graphene, carbon nanotubes, carbon nanofibers), silver nanowires, copper nanowires.

[0094] After the ablation electrode 20 is mounted on the electrode holder 10 at the distal end of the ablation catheter 200, the third insulating layer 26 contacts and connects with the electrode holder. When the ablation electrode 20 adheres to the wall, the first conductive layer 21 and the third insulating layer 26, which is in close contact with the electrode holder, are compressed and deformed under pressure. The connecting end of the third conductive layer 25 and the other connecting end of the second conductive layer 23 are connected to the control circuit board of the force sensing module of the device host through copper wires covered with insulating layers. A fixed capacitance value range is formed between the third conductive layer 25 and the second conductive layer 23, and the capacitance value is changed through the compressible insulating layer of the second insulating layer 24. The circuit principle of capacitance measurement is to set a fixed frequency PWM, apply a pulsed voltage signal to charge the two terminals of the capacitor, and determine the capacitance value based on the charging time. When the capacitance value changes, the charging time also changes. A set of simulated data tables is established through software algorithms. In actual use, the capacitance value is deduced from the table based on the change in charging time, and correlated with the contact pressure of the ablation electrode, thereby determining the pressure exerted by the ablation electrode on the blood vessel wall.

[0095] In addition, the ablation electrode 20 and the electrode support 10 can be manufactured as one piece or separately, and the ablation electrode 20 can be assembled onto the electrode support 10 by means of bonding, welding or other methods.

[0096] This application also provides an ablation catheter 200, which includes a catheter 200, a handle 300, and an ablation component 100 of any of the foregoing embodiments. The ablation component 100 is connected to the distal end of the catheter 200, and the handle 300 is connected to the proximal end of the catheter 200.

[0097] The catheter 200 is used for the routing of the leads for the ablation component 100. After the ablation component 100 is delivered to the target location via the catheter 200, the handle 300 controls the ablation component 100 to extend outside the sheath or guiding tube. The electrode support 10 is expanded by heating or applying electricity, allowing the ablation electrode 20 on the electrode support 10 to adhere to the wall, thus completing the ablation of the target area. Then, the ablation component 100 is retracted into the sheath or guiding tube. After moving the sheath or guiding tube and the electrode support 10 to the next ablation location, the handle 300 is operated to extend the ablation component 100 outside the sheath or guiding tube again. This process is repeated to complete the ablation of all designated areas.

[0098] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0099] 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: The electrode holder can shrink and expand radially, and is made of shape memory alloy; The electrode support is spiral-shaped in both the contracted and expanded states. During the transition from the contracted state to the expanded state, the number of spiral turns of the electrode support decreases and the spiral diameter increases.

2. The ablation component according to claim 1, characterized in that, The ablation component also includes: An ablation electrode is disposed on the electrode support; A monitoring module is mounted on the electrode support, and the monitoring module includes a pressure detection component and / or a temperature detection component.

3. The ablation component according to claim 1, characterized in that, The electrode support is formed by spiraling strips.

4. The ablation component according to claim 3, characterized in that, The strip has multiple perforated holes.

5. The ablation component according to claim 4, characterized in that, The strip includes an end and multiple branches, one end of the multiple branches converges and connects to the end, and the other end of the multiple branches extends along the spiral direction of the electrode support. Along the extension direction of the branch, adjacent branches alternately approach and separate from each other, and multiple nodes are formed when adjacent branches approach each other. At least one of the multiple nodes is used for the installation of ablation electrodes and / or monitoring modules, and the hollow hole is formed by the adjacent branches and the nodes.

6. The ablation component according to claim 5, characterized in that, A groove is provided on the node, and the ablation electrode and / or the monitoring module are disposed in the groove.

7. The ablation component according to claim 5, characterized in that, Along the extension direction of the branch, the line shape of the branch is wavy.

8. The ablation component according to claim 5, characterized in that, The number of branches is four.

9. The ablation component according to claim 4, characterized in that, The plurality of the hollowed-out holes are evenly distributed along the length of the strip.

10. The ablation component according to claim 9, characterized in that, The area between two adjacent hollow holes on the strip is provided with a groove for embedding an ablation electrode and / or a monitoring module.

11. The ablation component according to claim 3, characterized in that, The strip is made of a two-way memory alloy or a one-way memory alloy.

12. The ablation component according to claim 3, characterized in that, An insulating layer is provided on the outer surface of the strip.

13. The ablation component according to claim 1, characterized in that, The ablation assembly further includes an ablation electrode, which is disposed on the electrode support; The ablation electrode comprises a first conductive layer, a first insulating layer, a second conductive layer, a second insulating layer, a third conductive layer, and a third insulating layer stacked sequentially. The first conductive layer constitutes the electrode layer. The first conductive layer and the second conductive layer are made of different materials. A blind hole with the same interconnection is provided between the first conductive layer and the second conductive layer. The first conductive layer and the second conductive layer are electrically connected through the blind hole. The second insulating layer is an elastic compressible insulating layer.

14. An ablation catheter, characterized in that, It includes a catheter, a handle, and an ablation assembly according to any one of claims 1-13, wherein the ablation assembly is connected to the distal end of the catheter, and the handle is connected to the proximal end of the catheter.

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