Ablation assembly and ablation catheter

Abstract

The embodiment of the invention 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 in particular, to an ablation assembly and an ablation catheter. Background Art

[0002] Catheter ablation is used for the treatment of various diseases such as various arrhythmias, tumors, hypertension, and diabetes. The ablation catheter plays a role in energy conduction and target lesion tissue positioning during the operation, and is a tool for implementing ablation.

[0003] Currently, most ablation technology heads usually adopt a stent with a mesh structure. When multiple ablation electrodes are arranged, the wall attachment rate of the ablation electrodes is not high. The expansion state of the mesh stent is adjusted by pushing and pulling the central wire or expanding and contracting the balloon. The structure of the electrode stent is relatively complex, requires a large-sized sheath to intervene, has a high surgical risk, and the structural stability of the electrode stent is not high and is prone to failure. Summary of the Invention

[0004] The embodiments of this application provide an ablation assembly and an ablation catheter. The size of the electrode stent after compression is small, the structure is simple, and it has better shape restorability.

[0005] In a first aspect, the embodiments of this application provide an ablation assembly. The ablation assembly includes an electrode stent that can be radially contracted and expanded, and the electrode stent is made of a shape memory alloy; wherein, the electrode stent is spiral in both the contracted state and the expanded state. During the process of switching from the contracted state to the expanded state, the number of turns of the electrode stent decreases, and the spiral diameter increases.

[0006] In this solution, the electrode stent is made of a shape memory alloy. By using the shape memory effect of the shape memory alloy and controlling the temperature of the electrode stent, the switching of the contraction and expansion states of the electrode stent can be achieved. Compared with the prior art in which the central wire pulls the electrode stent to deform or the balloon-type stent structure, the electrode stent made of the shape memory alloy has a simpler structure, and the size of the electrode stent after compression is smaller. Moreover, the electrode stent in this solution is spiral in both the contracted state and the expanded state. During the switching process of the contraction and expansion states of the electrode stent, only the spiral diameter and the number of turns of the electrode stent itself change. Compared with the shape memory alloy stent in the prior art, the amount of shape deformation of the electrode stent in this solution is relatively small during the switching process between the two shapes, so that the electrode stent has better shape restorability and a longer service life.

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

[0008] In the above technical solution, the ablation electrode is disposed on the electrode support, and the ablation electrode relies on the electrode support to adhere to the wall to achieve ablation of the target area. The monitoring module includes a pressure detection component and / or a temperature detection component. The pressure detection component can detect the wall adhesion force between the electrode support and the blood vessel wall, ensuring good wall adhesion while guaranteeing the safety of the operation and not easily damaging the blood vessel; and / or, the temperature detection component is mainly used to monitor the temperature of the corresponding ablation point during the ablation process to ensure the precise ablation of the ablation component.

[0009] In some embodiments, the electrode support is formed by helically winding a strip-shaped member.

[0010] In the above technical solution, the electrode support is formed by helically winding a strip-shaped member. The processing technology of the electrode support is simple, the cost is low, and it is easy to implement.

[0011] In some embodiments, a plurality of hollow holes are distributed on the strip-shaped member.

[0012] In the above technical solution, by distributing a plurality of hollow holes on the strip-shaped member, the setting of the hollow holes reduces the stiffness of the strip-shaped member, making it easier for the strip-shaped member to deform during the shape switching process, and the shape switching of the electrode support is smoother, and the reliability of the electrode support is high.

[0013] In some embodiments, the strip-shaped member includes an end portion and a plurality of branches. One ends of the plurality of branches converge and are connected to the end portion, and the other ends of the plurality of branches all extend along the helical direction of the electrode support; along the extending direction of the branches, adjacent two branches alternately approach and separate from each other, and adjacent two branches approaching each other form a plurality of nodes. At least one of the plurality of nodes is used for installing the ablation electrode and / or the monitoring module, and adjacent two branches and the nodes enclose to form a hollow hole.

[0014] In the above technical solution, by dividing the strip-shaped member into a plurality of branches, compared with the strip-shaped member being a single sheet structure, the formation of a plurality of branches can reduce the stiffness of the strip-shaped member and improve the deformation ability of the electrode support. Under the condition of the same stiffness of the strip-shaped member, the existence of the branches can, after the electrode support adheres to the wall, make the contact area between the plurality of branches and the blood vessel wall larger, and have better support for the blood vessel wall. In addition, adjacent two branches among the plurality of branches approach each other to form a plurality of nodes, and adjacent two branches separate and enclose with the nodes to form a hollow hole, so that the spiral electrode support has the characteristics of an approximate net structure, has high redundancy, good deformation performance of the electrode support, and a small size after compression. And, the size of the node in the strip-shaped member is larger than the width size of a single branch, with higher stability, which is conducive to the installation of the ablation electrode and / or the monitoring module and ensures the installation stability of the ablation electrode and / or the monitoring module.

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

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

[0017] In some embodiments, along the extending direction of the branch, the shape of the branch is wavy.

[0018] In the above technical solution, by adopting a wavy shape for the branch, the shape of the hollow hole on the strip member is approximately elliptical, avoiding the formation of sharp ends on the strip member, and the electrode bracket is not likely to scratch the blood vessel wall, and the installability is higher.

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

[0020] In the above technical solution, by adopting four branches, when the electrode bracket adheres to the wall, the four branches on the strip member contact the blood vessel wall, and the contact area is relatively larger, providing better support for the blood vessel.

[0021] In some embodiments, a plurality of hollow holes are equally spaced along the length direction of the strip member.

[0022] In the above technical solution, by equally spacing a plurality of hollow holes along the length direction of the strip member, the deformation ability of different regions on the strip member is relatively more uniform, and the electrode bracket is not likely to have a problem of excessive local stress.

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

[0024] In the above technical solution, by providing a groove between two adjacent hollow holes on the strip member and embedding the ablation electrode and / or the monitoring module in the groove, the groove can accommodate at least part of the ablation electrode and / or the monitoring module. After the ablation electrode and / or the monitoring module are installed in the groove, the size of the ablation assembly is smaller. Moreover, the groove can limit the ablation electrode and / or the monitoring module, making the installation stability of the ablation electrode and / or the monitoring module on the electrode bracket higher.

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

[0026] In the above technical solution, the material of the strip is a two-way shape memory alloy. By utilizing the two-way memory principle and training the memory metal, with the phase change temperature as the boundary, the ablation electrode on the expanded electrode support can achieve wall attachment. When the material of the strip is a one-way shape memory alloy, it is realized by using the superelasticity of the shape memory alloy. The electrode support is sent to a specified position in the catheter, and then the catheter is withdrawn, and the electrode support automatically springs open and fits with the blood 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 providing 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, the monitoring module, or the heating wire, etc., making the ablation component safer and more reliable to use.

[0029] In some embodiments, the ablation component further includes an ablation electrode, and the ablation electrode is disposed on the 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 that are sequentially stacked. The first conductive layer constitutes the electrode layer. The materials of the first conductive layer and the second conductive layer are different. There are the same connected blind holes between the first conductive layer and the second conductive layer, and the first conductive layer and the second conductive layer are electrically connected through the blind holes. The second insulating layer is 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 (such as a generator) through a wire, and it forms a loop with the neutral electrode attached to the patient's skin, so that the first conductive layer emits high-frequency alternating current into the vascular tissue to achieve denervation ablation of the ablation area; since the materials of the first conductive layer and the second conductive layer are different, there are the same connected blind holes between the first conductive layer and the second conductive layer, and the first conductive layer and the second conductive layer are electrically connected through the blind holes, so that a thermocouple junction is formed between the first conductive layer and the second conductive layer at the position of the blind hole. The connection end of the second conductive layer is connected to the temperature module control circuit board of the device host (such as a generator) through a wire of the same material as it to realize the temperature measurement function of the ablation electrode. The third conductive layer and the second conductive layer can be connected to the control circuit board of the force sensing module of the device host. After the ablation electrode adheres to the wall, since the second insulating layer is an elastic compressible insulating layer, a capacitive pressure sensor is formed between the third conductive layer and the second conductive layer to realize pressure monitoring of the ablation electrode.

[0031] In a second aspect, an ablation catheter is further provided in an embodiment of the present application. The ablation catheter includes a catheter, a handle, and the 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, a catheter is provided for threading and arranging the wire of the ablation assembly. After the ablation assembly is transported to the target position along with the catheter, the ablation assembly is controlled by a handle to extend out of the sheath or the guiding catheter. The electrode support is expanded by heating or energizing, so that the ablation electrodes on the electrode support adhere to the wall, and ablation of the target area is completed. Then, the ablation assembly is retracted into the sheath or the guiding catheter. After moving the sheath or the guiding catheter and the electrode support to the next ablation position, the handle is operated again to make the ablation assembly extend out of the sheath or the guiding catheter, and so on, until the ablation of all specified areas is completed.

[0033] Other features and advantages of the present application will be described in detail in the subsequent specific implementation section. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] 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 some embodiments of the present application, and thus should not be regarded as limiting the scope. For those of ordinary skill in the art, other relevant drawings can be obtained based on these drawings without creative efforts.

[0035] Figure 1 Schematic structural diagram of the electrode support in the ablation assembly provided for some embodiments of the present application;

[0036] Figure 2 Schematic structural diagram of the electrode support in the ablation assembly provided for other embodiments of the present application in a contracted state;

[0037] Figure 3 For Figure 2 Enlarged schematic diagram of A in

[0038] Figure 4 For Figure 2 Schematic structural diagram of the electrode support from another angle in

[0039] Figure 5 For Figure 2 Schematic structural diagram of the electrode support from yet another angle in

[0040] Figure 6 Schematic structural diagram of the electrode support in the ablation assembly provided for other embodiments of the present application in an expanded state;

[0041] Figure 7 For Figure 6 Enlarged schematic diagram of B in

[0042] Figure 8 For Figure 6 Schematic structural diagram of the electrode support from another angle in

[0043] Figure 9 is Figure 6 a schematic structural view of the middle electrode bracket from another angle;

[0044] Figure 10 is a schematic structural view of an ablation catheter provided by some embodiments of the present application;

[0045] Figure 11 is a schematic structural view of the electrode bracket in a contracted state in an ablation assembly provided by some other embodiments of the present application;

[0046] Figure 12 is a schematic structural view of the electrode bracket in an expanded state in an ablation assembly provided by some other embodiments of the present application;

[0047] Figure 13 is a partial schematic view of an ablation electrode mounted on an electrode bracket in an ablation assembly provided by some embodiments of the present application;

[0048] Figure 14 is Figure 13 a cross-sectional view of the ablation electrode in the middle.

[0049] Reference numerals: 100 - ablation assembly; 10 - electrode bracket; 11 - strip member; 111 - end portion; 112 - secondary branch; 113 - branch; 114 - node; 115 - hollow 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 - catheter; 300 - handle. Detailed Description of the Specific Embodiments

[0050] To make the objectives, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Apparently, the described embodiments are some, but not all, of the embodiments of the present application. The components of the embodiments of the present application described and illustrated herein can be arranged and designed in various different configurations.

[0051] 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 claimed, but merely represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present application without creative efforts fall within the scope of protection of the present application.

[0052] It should be noted that: like reference numerals and letters denote similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0053] 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 drawings, or the orientation or positional relationship in which the product of this application is customarily placed during use. This is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present application. In addition, the terms "first", "second", "third", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0054] In the description of the present application, it should also be noted that unless otherwise clearly specified and limited, the terms "arranged" and "connected" should be understood in a broad sense. For example, they can be fixedly connected, detachably connected, or integrally connected; they can be directly connected, or indirectly connected through an intermediate medium, and can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific situations.

[0055] In the related art, the heads of most ablation techniques usually adopt a stent with a mesh structure. When multiple ablation electrodes are arranged, the wall attachment rate of the ablation electrodes is not high. The expansion state of the mesh stent is adjusted by pushing and pulling the central wire or the contraction and expansion of the balloon. The electrode stent structure is relatively complex, and large-sized sheaths need to be introduced, resulting in a relatively high surgical risk.

[0056] Of course, there are also stent structures made of shape memory alloy, and the memory characteristics of the shape memory alloy are used to realize the expansion and contraction between the electrodes. However, in the prior art, the shape differences between the contracted state and the expanded state of the shape memory alloy stent are relatively large, and there are problems such as relatively poor morphological recovery and relatively limited radial dimension change range.

[0057] In view of this, the embodiments of the present application provide an ablation assembly. Please refer to Figures 1 to 14 , the ablation assembly 100 includes an electrode stent 10 that can be radially contracted and expanded. The electrode stent 10 is made of shape memory alloy; wherein, the electrode stent 10 is in a spiral shape in both the contracted state and the expanded state. During the process of switching from the contracted state to the expanded state, the number of turns of the spiral of the electrode stent 10 decreases, and the spiral diameter increases.

[0058] In this solution, the electrode stent 10 is made of shape memory alloy. By using the shape memory effect of the shape memory alloy and controlling the temperature of the electrode stent 10, the switching of the contraction and expansion states of the electrode stent 10 can be realized. Compared with the prior art in which the central wire pulls the electrode stent 10 to deform or the balloon-type stent structure, the electrode stent 10 made of shape memory alloy has a simpler structure, and the size of the compressed electrode stent 10 is smaller. And, please combine Figure 2 andFigure 6 or Figure 11 and Figure 12 In this solution, the electrode stent 10 is spiral in both the contracted state and the expanded state. During the morphological switching process between the contracted state and the expanded state of the electrode stent 10, only the spiral diameter and the number of spiral turns of the electrode stent 10 change. Compared with the shape memory alloy stent in the prior art, during the switching process between the two shapes of the electrode stent 10 in this solution, the amount of morphological deformation is relatively small, making the electrode stent 10 have better shape recovery and a longer service life.

[0059] It can be understood that since only the spiral diameter and the number of spiral turns of the electrode stent 10 change, compared with the influence on the dimensional change of the electrode stent 10 in the prior art due to the large difference in morphology before and after deformation, the electrode stent 10 in this solution is spiral in both the contracted state and the expanded state, and the electrode stent 10 has a relatively larger deformation range in terms of diameter size, which can adapt to a larger range of blood vessel wall attachment and is beneficial for the ablation electrodes on the electrode stent 10 to achieve a higher wall attachment rate.

[0060] Shape memory alloys (SMA) are materials composed of more than two metal elements that have a shape memory effect (SME) through thermoelastic and martensitic phase transformations and their inversions.

[0061] The temperature conduction of the electrode stent 10 can be achieved by means of electric heating or heat conduction, so that the electrode stent 10 is switched to the phase transition temperature to control the temperature to achieve the shape switching of the electrode stent 10. For example, at least part of the electrode stent 10 close to the catheter 200 can be wound with a heating wire. By energizing the heating wire, the heating wire generates heat. Since the heating wire is in contact with the electrode stent 10, the heat of the heating wire is transferred to the electrode stent 10, so that the electrode stent 10 reaches the phase transition temperature. Of course, in the way of heat transfer, a heat transfer wire is arranged in the catheter 200. The heat transfer wire is connected to the electrode stent 10 and can be wound around at least part of the proximal end of the electrode stent 10. The handle at the front end of the catheter 200 can transfer heat to the electrode stent 10 by heating or through the heat transfer wire, and the deformation of the electrode stent 10 can also be achieved. The main improvement point of this solution lies in the improvement of the self-structure of the electrode stent 10, and the structure part of heat transfer or heating of the electrode stent 10 will not be elaborated too much. Those skilled in the art can realize the morphological switching of the electrode stent 10 according to the above two methods.

[0062] The following embodiments are described non - restrictively based on radiofrequency ablation. Those skilled in the art can understand that the following description is only exemplary. Similarly, the ablation catheter provided in the present application can be adapted to other ablation scenarios such as ultrasonic 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 further includes an ablation electrode 20 and a monitoring module. The ablation electrode 20 is disposed on the electrode support 10; the monitoring module is disposed on the electrode support 10, and the monitoring module includes a pressure detection component and / or a temperature detection component. The ablation electrode 20 is disposed on the electrode support 10, and the ablation electrode 20 ablates the target area after adhering to the wall by relying on the electrode support 10. The monitoring module includes a pressure detection component and / or a temperature detection component. The pressure detection component can detect the wall - adhering force between the electrode support 10 and the blood vessel wall, ensuring good wall - adhering property while guaranteeing the safety of the operation and being not easy to damage the blood vessel; and / or, the temperature detection component is mainly used to monitor the temperature of the corresponding ablation point during the ablation process to ensure the precise ablation of the ablation assembly.

[0064] On the electrode support 10, the positions of the monitoring module and the ablation electrode 20 can be adjacently arranged, that is, the pressure detection component and / or the temperature detection component in the monitoring module are arranged close to the ablation electrode 20, so that the monitoring module can more precisely detect the wall - adhering force of the ablation electrode and the temperature of the ablation point. Of course, the monitoring module and the ablation electrode 20 can be integrally formed, that is, the monitoring module and the ablation electrode 20 are combined into one body, and through the ablation electrode 20, both the ablation function and the temperature and / or pressure monitoring function can be realized.

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

[0066] In some embodiments, please refer to Figure 1 , the electrode support 10 is formed by helically winding a strip - shaped member 11. Forming the electrode support 10 by helically winding the strip - shaped member 11, the processing technology of the electrode support 10 is simple, the cost is low, and it is easy to implement. Along the extending direction of the electrode support 10, a plurality of ablation electrodes 20 are spaced apart and distributed on the electrode support 10.

[0067] In some embodiments, please refer to Figure 2 , Figure 4 ,Figure 11 and Figure 12 On the strip-shaped member 11, a plurality of hollow holes 115 are distributed. By distributing a plurality of hollow holes 115 on the strip-shaped member 11, the setting of the hollow holes 115 reduces the stiffness of the strip-shaped member 11, making it easier for the strip-shaped member 11 to deform during the shape switching process, and the shape switching of the electrode bracket 10 is smoother, and the reliability of the electrode bracket 10 is high.

[0068] The hollow hole 115 refers to a hole structure distributed on the strip-shaped member 11, and the hollow hole 115 is arranged through the thickness direction of the strip-shaped member 11. The shape of the hollow hole 115 can be various, and the shape of the hollow hole 115 can be circular, square, parallelogram or other special shapes, etc. The shape of the hollow hole 115 is specifically determined according to the actual situation.

[0069] In some embodiments, please refer to Figures 2 to 8 The strip-shaped member 11 includes an end portion 111 and a plurality of branches 113. One ends of the plurality of branches 113 converge and are connected to the end portion 111, and the other ends of the plurality of branches 113 all extend along the spiral direction of the electrode bracket 10; along the extending direction of the branch 113, adjacent two branches 113 approach and separate alternately, and adjacent two branches 113 approaching form a plurality of nodes 114, and at least one of the plurality of nodes 114 is used for installing the ablation electrode 20 and / or the monitoring module, and adjacent two branches 113 and the node 114 enclose to form a hollow hole 115. By dividing the strip-shaped member 11 into a plurality of branches 113, compared with the strip-shaped member 11 being a single sheet structure, the formation of the plurality of branches 113 can reduce the stiffness of the strip-shaped member 11 and improve the deformation ability of the electrode bracket 10 at the same time. When the strip-shaped member 11 has the same stiffness, the existence of the branches 113 can make the contact area between the plurality of branches 113 and the blood vessel wall larger after the electrode bracket 10 adheres to the wall, and has better support for the blood vessel wall. In addition, adjacent two branches 113 among the plurality of branches 113 approach to form a plurality of nodes 114, and adjacent two branches 113 separate and enclose with the node 114 to form a hollow hole 115, so that the spiral electrode bracket 10 has the characteristics of an approximate net structure, has high redundancy, good deformation performance of the electrode bracket 10, and a small size after compression. And, the size of the node 114 in the strip-shaped member 11 is larger than the width size of a single branch 113, with higher stability, which is conducive to the installation of the ablation electrode 20 and / or the monitoring module, and ensures the installation stability of the ablation electrode and / or the monitoring module.

[0070] The multiple branches 113 on the strip-shaped member 11 are formed by cutting and grooving on the strip-shaped member 11. By cutting and engraving on the strip-shaped member 11, the multiple branches 113 on the strip-shaped member 11 are formed. One end of the strip-shaped member 11 is not grooved to form the end portion 111. The number of branches 113 can be two, three, four, five, etc. The number of branches 113 can be determined according to the actual situation. Please refer to Figure 3 , the node 114 refers to the common part formed at the intersection of two branches 113, and the node 114 connects the local parts of the two branches 113 into one body.

[0071] Adjacent two branches 113 approach and separate alternately from each other, which means that the two branches 113 each extend along the spiral direction of the strip-shaped member 11, and the two branches 113 converge to form the node 114 after approaching each other, and then the two branches 113 separate from each other and then approach each other again to converge to form the node 114, and so on.

[0072] In some embodiments, please refer to Figure 6 and Figure 7 , a groove 116 is provided on the node 114, and the ablation electrode 20 and / or the monitoring module are arranged in the groove 116. By providing the groove 116 on the node 114 and arranging the ablation electrode 20 and / or the 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 the monitoring module. After the ablation electrode 20 and / or the monitoring module are installed in the groove 116 of the node 114, the size of the ablation assembly 100 is smaller. On the other hand, the groove 116 can play a role in limiting the ablation electrode 20 and / or the monitoring module, making the installation stability of the ablation electrode 20 and / or the monitoring module on the electrode bracket 10 higher.

[0073] The groove 116 can be a blind hole. Of course, the groove 116 can also be a through hole, which is specifically determined according to the actual situation. Arranging the ablation electrode 20 and / or the monitoring module in the groove 116 means that one groove 116 can be used for installing one ablation electrode 20, or one groove 116 can also be used for installing the monitoring module, or one groove 116 can install both the ablation electrode 20 and the monitoring module. In this embodiment, the monitoring module and the ablation electrode 20 are of an integrated structure, and the ablation electrode 20 is installed in the groove 116. Of course, the monitoring module and the ablation electrode 20 can be of a split structure, and the two grooves 116 for installing the ablation electrode 20 and the monitoring module are arranged adjacent to each other.

[0074] Please refer to Figure 7, when the ablation electrode 20 is installed in the groove 116, a part of the ablation electrode 20 protrudes from the groove 116, that is to say, the ablation electrode 20 is arranged to protrude from the outside of the electrode support 10, which is convenient for the ablation electrode 20 to contact the blood vessel wall. Similarly, when the monitoring module is installed in the groove 116, the monitoring module can also partially protrude from the groove 116, that is to say, the monitoring module is arranged to protrude from the outside of the electrode support 10, which is convenient for the monitoring module to contact the blood vessel wall and better monitor the temperature and pressure of 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 in an interference fit, ultrasonic welding or adhesive fixation, etc.

[0076] In some embodiments, please refer to Figures 2 to 9 , along the extension direction of the branch 113, the shape of the branch 113 is wavy. By adopting the branch 113 to be wavy, the shape of the hollow hole 115 on the strip 11 is approximately elliptical, avoiding the formation of sharp ends 111 on the strip 11, and the electrode support 10 is not likely to scratch the blood vessel wall, and the installability is higher.

[0077] In some embodiments, the number of branches 113 is four. By adopting the number of branches 113 to be four, when the electrode support 10 adheres to the wall, the four branches 113 on the strip 11 contact the blood vessel wall, and the contact area is relatively larger, providing better support for the blood vessel.

[0078] In this embodiment, please continue to refer to Figure 2 and Figure 6 , the strip 11 further includes sub-branches 112. The sub-branches 112 are located between the end 111 and the branches 113. When the number of branches 113 is four, the number of sub-branches 112 is two. The ends of the two sub-branches 112 away from the branches 113 converge to form the end 111, and the other ends of the two sub-branches 112 are respectively connected to one end of the two branches 113. The sub-branches 112 play a transitional role, making the smoothness of the electrode support 10 better.

[0079] In some embodiments, please refer to Figure 11 and Figure 12 , a plurality of hollow holes 115 are equally spaced along the length direction of the strip 11. By equally spacing a plurality of hollow holes 115 along the length direction of the strip 11, the deformation ability of different regions on the strip 11 is relatively more uniform, and the electrode support 10 is not likely to have a problem of excessive local stress.

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

[0081] In some embodiments, a groove for embedding the ablation electrode 20 and / or the monitoring module is provided in the region between two adjacent hollow holes 115 on the strip member 11. By providing a groove between two adjacent hollow holes 115 on the strip member 11, the ablation electrode 20 and / or the monitoring module is embedded in the groove, and the groove 116 can accommodate at least a part of the ablation electrode 20 and / or the monitoring module. After the ablation electrode 20 and / or the monitoring module is installed in the groove, the size of the ablation assembly 100 is smaller. Moreover, the groove 116 can limit the ablation electrode 20 and / or the monitoring module, making the installation stability of the ablation electrode 20 and / or the monitoring module on the electrode bracket 10 higher.

[0082] In some embodiments, the material of the strip member 11 is a two-way shape memory alloy or a one-way shape memory alloy. When the material of the strip member 11 is a two-way shape memory alloy, by using the two-way memory principle and training the memory metal, with the phase transition temperature as the boundary, the ablation electrode on the expanded electrode bracket 10 can achieve wall attachment. When the material of the strip member 11 is a one-way shape memory alloy, it is realized by using the memory characteristic and superelasticity of the shape memory alloy. The electrode bracket 10 is sent to the designated position along with the catheter 200. By using the handle to control the ablation assembly 100 to extend out of the sheath or the guiding catheter, the electrode bracket 10 automatically pops open and fits with the blood vessel wall.

[0083] Specifically, taking the memory alloy of the strip member 11 as a two-way shape memory alloy as an example, the memory metal is trained to achieve state one when heated and restore the original state zero when cooled. The heat can be transferred to the electrode bracket 10 by means including but not limited to electrification and heat conduction. After the electrode bracket 10 is heated to the phase transition temperature, the structure of the electrode bracket 10 made of the two-way shape memory metal changes, expands along the diameter direction, the diameter changes from A to B, the electrode bracket 10 contracts along the axial direction, and the axial length of the electrode bracket 10 becomes shorter. At this time, the ablation electrode on the outer surface of the electrode bracket 10 can fit with the blood vessel wall in the diameter range D1 - D2. After ablation is performed on all points and completed, the temperature of the electrode bracket 10 is adjusted to be below the phase transition temperature, and the two-way shape memory metal restores its original shape, the diameter changes from B back to A, the electrode bracket 10 contracts along the diameter direction, the diameter becomes smaller, extends along the axial direction, and the length becomes longer. At this time, the ablation electrode on the outer surface of the electrode bracket 10 can fit with the blood vessel wall in the diameter range D0 - D1. Among them, D0 < D1 < D2. For example, 3mm ≤ D0 < 5mm, 5mm ≤ D1 < 8mm, 8mm ≤ D2 < 12mm. By using the temperature control function of the handle, the electrode bracket 10 can present two different expansion states in the blood vessel to ensure the fitting of the electrode bracket 10 with the blood vessel wall.

[0084] An electrode support 10 using a one-way shape memory alloy can also be realized, without temperature control. The phase change temperature of the electrode support 10 is set to the body fluid temperature of the human body. After the electrode support 10 is placed in the human body, it automatically expands without the need for temperature control again. The electrode support 10 is sent to a specified position along with the catheter 200. The ablation assembly 100 is controlled by the handle to extend out of the sheath or the guiding catheter, and the spiral electrode support 10 automatically pops open and fits against the blood vessel wall. When the position of the electrode support 10 needs to be moved, the ablation assembly 100 is retracted into the sheath or the guiding catheter. After moving the sheath or the guiding catheter and the ablation assembly 100 to the next ablation position, the electrode support 10 is extended for ablation.

[0085] In some embodiments, an insulating layer is provided on the outer surface of the strip 11. By providing the insulating layer on the strip 11, the insulating layer plays an insulating role, and the electrode support 10 will not short-circuit with the ablation electrode 20, the monitoring module, or the heating wire, etc., and the ablation assembly 100 is safer and more reliable to use.

[0086] The insulating layer refers to a layer of material used in electrical equipment to isolate electrical components from the shell or other components. Its main function is to prevent short circuits or electric leakage in electrical equipment.

[0087] In some embodiments, please refer to Figure 13 and Figure 14 , the ablation assembly 100 further includes an ablation electrode 20, and the ablation electrode 20 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 that are sequentially stacked. The first conductive layer 21 constitutes the electrode layer. The materials of the first conductive layer 21 and the second conductive layer 23 are different. Blind holes 27 that are the same and communicate are 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 holes 27, and the second insulating layer 24 is an elastic and compressible insulating layer.

[0088] The first conductive layer 21 can be connected to the control circuit board of the device host (such as a generator) through a wire. It forms a loop with the neutral electrode attached to the patient's skin, enabling the first conductive layer 21 to emit high-frequency alternating current into the vascular tissue to achieve denervation ablation of the ablation area. Since the materials of the first conductive layer 21 and the second conductive layer 23 are different, blind holes 27 with the same connection are 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 holes 27, so that a thermocouple junction is formed between the first conductive layer 21 and the second conductive layer 23 at the position of the blind holes 27. The connection end of the second conductive layer 23 is connected to the temperature module control circuit board of the ablation device host (such as a generator) through a wire of the same material as it, 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 device host. After the ablation electrode 20 adheres to the wall, since the second insulating layer 24 is an elastic compressible insulating layer, a capacitive pressure sensor is formed between the third conductive layer 25 and the second conductive layer 23, realizing the 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, for example but not limited to: silicone elastomers, PU, TPU with microporous (the microporous structure can be in the form of columns, pyramids, honeycombs, multi-chambers, etc.) structures.

[0090] The third insulating layer 26 is a polymer material. The polymer material can be but not limited to: materials such as PI, PET, PU, fluorine-containing polymers, etc.

[0091] The second conductive layer 23 is a metal conductor film with a material different from that of the first conductive layer 21, such as constantan or copper. The first conductive layer 21 and the second conductive layer 23 are electrically connected through the blind holes 27. The hole wall surface of the blind holes 27 is electroplated with the same metal material as the first conductive layer 21, so that a thermocouple junction is formed between the first conductive layer 21 and the second conductive layer 23 here. The connection end of the second conductive layer 23 is connected to the temperature module control circuit board of the device host (such as a generator) through a wire of the same material as it. When the first conductive layer 21 and the second conductive layer 23 form a loop, due to the different materials of the first conductive layer 21 and the second conductive layer 23, one end of the thermocouple junction is in a high-temperature environment and the other end is in a low-temperature environment, and an electromotive force proportional to the temperature difference is generated in the loop. The device host (such as a generator) measures the electromotive force and converts it into temperature to realize the temperature monitoring of the ablation area. This combination forms a temperature sensor.

[0092] The conditioning circuit of the temperature sensor realizes the logic of temperature measurement. The device host is provided with a temperature conditioning circuit, which is mainly composed of an operational amplifier and a filtering circuit. After filtering and amplifying the electromotive force at both ends of the thermocouple signal, it is converted into an analog signal and sent to the abc circuit, and then converted into a digital signal, so that the main channel of the cpu can be applied to software processing to calculate the current actual working temperature.

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

[0094] After the ablation electrode 20 is loaded on the electrode bracket 10 at the distal end of the ablation catheter 200, the third insulating layer 26 is in contact connection with the electrode bracket. When the ablation electrode 20 adheres to the wall, the first conductive layer 21 and the third insulating layer 26 closely adhering to the electrode bracket are compressed and deformed under pressure. The connection end of the third conductive layer 25 and the other connection end of the second conductive layer 23 are connected to the control circuit board of the force sensing module of the device host through a copper wire coated with an insulating layer. A fixed capacitance value range is formed between the third conductive layer 25 and the second conductive layer 23, and the change of the capacitance value is realized 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, charge the two poles of the capacitor, and judge the size of the capacitance value according to the length of the capacitor charging time. When the capacitance value changes, the charging time also changes. An analog data table is established through software algorithms. During actual use, the size of the capacitance value is inversely deduced by looking up the table according to the change of the charging time, which is associated with the abutting pressure of the ablation electrode, so as to judge the pressure exerted by the ablation electrode on the blood vessel wall.

[0095] In addition, the ablation electrode 20 and the electrode bracket 10 can be integrally processed, or they can be processed separately, and the ablation electrode 20 is assembled to the electrode bracket 10 by means of bonding, welding, etc.

[0096] The embodiment of the present application also provides an ablation catheter 200. The ablation catheter 200 includes a catheter 200, a handle 300, and the ablation assembly 100 of any of the foregoing embodiments. The ablation assembly 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 arranged for the wire of the ablation assembly 100 to pass through. After the ablation assembly 100 is transported to the target position following the catheter 200, the handle 300 is used to control the ablation assembly 100 to extend out of the sheath or the guiding catheter. The electrode support 10 is expanded by heating or electrifying, so that the ablation electrodes 20 on the electrode support 10 adhere to the wall, and ablation of the target area is completed. Then, the ablation assembly 100 is retracted into the sheath or the guiding catheter. After the sheath or the guiding catheter and the electrode support 10 are moved to the next ablation position, the handle 300 is operated again to make the ablation assembly 100 extend out of the sheath or the guiding catheter. And so on, until the ablation work of all specified areas is completed.

[0098] It should be noted that, without conflict, the features in the embodiments of the present application can be combined with each other.

[0099] The above are only the preferred embodiments of the present application and are not intended to limit the present application. For those skilled in the art, the present application can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included within the protection scope of the present application.

Claims

1. An ablation component, characterized in that, Comprising: An electrode support that can be radially contracted and expanded, made of a shape memory alloy; Wherein, the electrode support is spiral in both the contracted state and the expanded state. During the process of switching from the contracted state to the expanded state, the number of turns of the spiral of the electrode support decreases, and the spiral diameter increases.

2. The ablation assembly according to claim 1, wherein The ablation assembly further includes: An ablation electrode disposed on the electrode support; A monitoring module disposed on the electrode support, the monitoring module including a pressure detection component and / or a temperature detection component.

3. The ablation assembly according to claim 1, wherein The electrode support is formed by spirally winding a strip-shaped member.

4. The ablation assembly according to claim 3, wherein A plurality of hollow holes are distributed on the strip-shaped member.

5. The ablation assembly according to claim 4, wherein The strip-shaped member includes an end portion and a plurality of branches. One ends of the plurality of branches converge and are connected to the end portion, and the other ends of the plurality of branches all extend along the spiral direction of the electrode support; Along the extending direction of the branch, adjacent two branches alternately approach and separate from each other. Adjacent two branches approaching each other form a plurality of nodes, and at least one of the plurality of nodes is used for installing the ablation electrode and / or the monitoring module. Adjacent two branches and the node enclose to form the hollow hole.

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

7. The ablation assembly according to claim 5, wherein Along the extending direction of the branch, the linear shape of the branch is wavy.

8. The ablation assembly according to claim 5, wherein The number of the branches is four.

9. The ablation assembly according to claim 4, wherein The plurality of hollow holes are equally spaced along the length direction of the strip-shaped member.

10. The ablation assembly according to claim 9, wherein, A groove for embedding the ablation electrode and / or the monitoring module is provided in the area between two adjacent hollow holes on the strip-shaped member.

11. The ablation assembly according to claim 3, wherein, The material of the strip-shaped member is a two-way memory alloy or a one-way memory alloy.

12. The ablation assembly according to claim 3, wherein, An insulating layer is provided on the outer surface of the strip-shaped member.

13. The ablation assembly according to claim 1, wherein The ablation assembly further includes an ablation electrode, and the ablation electrode is disposed on the 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 that are sequentially stacked. The first conductive layer constitutes the electrode layer. The materials of the first conductive layer and the second conductive layer are different. Blind holes that are the same and communicate are 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 holes. The second insulating layer is an elastic and compressible insulating layer.

14. An ablation catheter, characterized in that, Including a catheter, a handle, and the ablation assembly according to any one of claims 1-13, 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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