Ablation assembly and radiofrequency ablation catheter

Abstract

The application relates to an ablation assembly and a radiofrequency ablation catheter. A shape-changing frame body has a contracted state and an expanded state. An ablation electrode group comprises a plurality of electrode elements distributed on the surface of the shape-changing frame body. In the expanded state of the shape-changing frame body, the plurality of electrode elements can be respectively constructed into a plurality of annular track unit groups and a plurality of linear track unit groups in the axial and circumferential directions of the shape-changing frame body. The annular track unit groups surround the shape-changing frame body in the circumferential direction, and the linear track unit groups are linearly distributed in the axial direction of the shape-changing frame body. The plurality of electrode elements in the ablation electrode group can greatly expand the treatment range of ablation in the blood vessel by forming the plurality of annular track unit groups and the plurality of linear track unit groups in the axial and circumferential directions of the shape-changing frame body. With the expansion of the shape-changing frame body, a larger treatment range can be achieved without axial movement and circumferential rotation, the treatment efficiency can be effectively improved, the operation difficulty can be reduced, and the development of ablation treatment technology is facilitated.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to ablation components and radiofrequency ablation catheters. Background Technology

[0002] Radiofrequency ablation technology primarily relies on radiofrequency therapeutic devices with ablation and cutting functions, and its treatment mechanism is mainly based on thermal effects. When radiofrequency current flows through biological tissue, the rapid changes in the electromagnetic field cause polarized water molecules within the tissue to move at high speeds, generating heat (i.e., endogenous thermal effect). This leads to the evaporation, drying, shrinkage, and shedding of water inside and outside the cells, resulting in aseptic necrosis, thereby achieving the therapeutic goal. Conventional multipolar ablation generally involves superficial ablation by discharging radiofrequency electrodes onto a backplate, and the arrangement of the radiofrequency electrodes cannot cover a large treatment area, resulting in treatment effects that are not ideal. Summary of the Invention

[0003] Therefore, it is necessary to provide an ablation component and a radiofrequency ablation catheter to address at least one of the aforementioned technical problems.

[0004] This application provides an ablation component, the ablation component comprising:

[0005] A deformable frame, which has a contracted state and an extended state;

[0006] The ablation electrode assembly includes multiple electrode elements distributed on the surface of the deformable frame. In the unfolded state of the deformable frame, the multiple electrode elements can be constructed into multiple annular trajectory unit groups and multiple linear trajectory unit groups in the axial and circumferential directions of the deformable frame, respectively. The annular trajectory unit groups surround the deformable frame circumferentially, and the linear trajectory unit groups are linearly distributed along the axial direction of the deformable frame.

[0007] In one embodiment, each of the annular trajectory unit groups forms a radial ablation energy circle in the radial direction of the deformed frame, and adjacent radial ablation energy circles formed by adjacent annular trajectory unit groups do not overlap; and / or,

[0008] Each of the linear trajectory unit groups forms an axial ablation energy circle along the axial direction of the deformed frame, and the adjacent axial ablation energy circles formed by adjacent linear trajectory unit groups do not overlap.

[0009] In one embodiment, the plurality of electrode elements in each of the annular trajectory unit groups are arranged in a circular trajectory along the circumference of the deformable frame, and the plane containing the circular trajectory is perpendicular to the axis of the deformable frame; and / or,

[0010] The spacing between adjacent electrode elements in each of the said annular trajectory unit groups is the same; and / or

[0011] The plurality of electrode elements in each of the linear trajectory unit groups are distributed along the axial direction of the deformable frame in a linear trajectory, and the linear trajectory is parallel to the axis of the deformable frame; and / or,

[0012] The spacing between adjacent electrode elements in each linear trajectory unit group is the same.

[0013] In one embodiment, each of the annular trajectory unit groups forms a radial ablation energy circle in the radial direction of the deformed frame, and at least partially adjacent radial ablation energy circles formed by adjacent annular trajectory unit groups overlap; and / or,

[0014] Each of the linear trajectory unit groups forms an axial ablation energy circle in the axial direction of the deformed frame, and at least some of the adjacent axial ablation energy circles formed by adjacent linear trajectory unit groups overlap.

[0015] In one embodiment, multiple electrode elements in each of the annular trajectory unit groups are arranged in annular trajectories along the circumference of the deformable frame, with at least partially adjacent planes containing the annular trajectories forming an angle; and / or,

[0016] The plurality of electrode elements in each linear trajectory unit group are distributed along the axial direction of the deformable frame in a straight trajectory, and at least some of the adjacent straight trajectories have an included angle.

[0017] In one embodiment, the electrode element has a medium filling hole for conveying a cooling medium.

[0018] In one embodiment, the deformable frame includes:

[0019] Multiple deformable support rods, all of which are spirally wound circumferentially along the axial direction, and multiple electrode elements of the ablation electrode group are disposed on the multiple deformable support rods, such that the multiple electrode elements can be constructed into multiple ring trajectory unit groups and multiple linear trajectory unit groups in the axial and circumferential directions, respectively.

[0020] A first clustering element is connected to the distal ends of the plurality of deformable support rods;

[0021] The second clustering element is connected to the proximal clustering of the plurality of deformable support rods.

[0022] In one embodiment, the deformable support rod has at least one of a wire delivery channel and a first medium delivery channel, wherein the wire delivery channel is used to pass through an energy delivery wire, the energy delivery wire is used to connect the electrode element, and the first medium delivery channel is used to deliver a cooling medium; and / or

[0023] The first clustering element includes a first clustering end and a plurality of first clustering support rods. The first clustering end is clustered and connected to the distal ends of the plurality of first clustering support rods. The number of first clustering support rods is the same as the number of deformation support rods. The proximal end of each first clustering support rod is connected to the distal end of one of the deformation support rods; and / or,

[0024] The second clustering element includes a second clustering end and a plurality of second clustering support rods. The second clustering end is connected to the proximal ends of the plurality of second clustering support rods in a clustering manner. The number of second clustering support rods is the same as the number of deformation support rods. The distal end of each second clustering support rod is connected to the proximal end of one of the deformation support rods.

[0025] In one embodiment, a second medium conveying channel is provided within the second cluster support rod, the second medium conveying channel being used to convey cooling medium; and / or,

[0026] At least one of the first bundle end and the second bundle end has a central through hole, the central through hole being used to pass through the inner core rod; and / or,

[0027] At least one of the first and second bundle support rods is an elastic rod; and / or,

[0028] The outer diameter of the plurality of first bundle support rods in the first bundle element gradually increases in the direction from the distal end to the proximal end of the first bundle element; and / or,

[0029] The outer diameter of the plurality of second bundle support rods in the second bundle element gradually increases in the direction from the proximal end to the distal end of the second bundle element.

[0030] In one embodiment, the deformable frame includes:

[0031] A conveying support rod is provided, and a medium filling channel is provided inside the conveying support rod for conveying cooling medium.

[0032] In one embodiment, the number of channel outlets of the medium infusion channel is the same as the number of electrode elements, with each channel outlet corresponding to one electrode element; or...

[0033] The number of conveying support rods is the same as the number of deformation support rods. All of the conveying support rods are spirally wound around the axial direction. Each conveying support rod corresponds to one deformation support rod. The number of channel outlets on each conveying support rod is the same as and corresponds to the number of electrode elements on the corresponding deformation support rod.

[0034] In one embodiment, the electrode element is a sleeve-shaped element having through-hole cavities at both ends, and the electrode element is sleeved on the deformable support rod; and / or,

[0035] The electrode element comprises at least two unit electrodes, at least one of which is a radio frequency signal receiving electrode, and the remaining unit electrodes are radio frequency signal transmitting electrodes.

[0036] This application provides a radiofrequency ablation catheter, the radiofrequency ablation catheter comprising:

[0037] An outer sheath having an axially penetrating inner cavity;

[0038] An inner core rod, which is movably assembled within the inner cavity of the outer sheath tube;

[0039] The ablation assembly is disposed at the distal end of the outer sheath tube, and the inner core rod is connected to the deformation frame of the ablation assembly for controlling the deformation frame to switch between the contracted state and the deployed state.

[0040] In the aforementioned ablation assembly and radiofrequency ablation catheter, multiple electrode elements in the ablation electrode group are evenly distributed in the circumferential direction of the deformable frame by means of multiple linear trajectory unit groups. Therefore, during the ablation treatment, the ablation assembly does not need to rotate circumferentially in the blood vessel to achieve ablation treatment around the blood vessel. At the same time, multiple electrode elements in the ablation electrode group are also evenly distributed in the axial direction of the deformable frame by means of multiple annular trajectory unit groups. Therefore, during the ablation treatment, the ablation assembly does not need to move along the axial direction of the blood vessel to achieve ablation treatment along a certain length of the axial direction of the blood vessel.

[0041] Therefore, it can be seen that the multiple electrode elements in the ablation electrode group form multiple annular trajectory unit groups and multiple linear trajectory unit groups in the axial and circumferential directions of the deformable frame. As the deformable frame unfolds, it can greatly expand the treatment range of ablation in the blood vessel, and no longer requires axial movement and circumferential rotation, which can achieve treatment over a larger area. This can effectively improve treatment efficiency, reduce operation difficulty, and contribute to the development of ablation therapy technology. Attached Figure Description

[0042] Figure 1This is a schematic diagram of the contracted state of a radiofrequency ablation catheter provided in one embodiment of this application.

[0043] Figure 2 This is a schematic diagram of the deployed state of a radiofrequency ablation catheter provided in one embodiment of this application.

[0044] Figure 3 This is a schematic diagram illustrating the formation state of the radial ablation energy ring and the axial ablation energy ring according to an embodiment of this application.

[0045] Figure 4 This is a schematic diagram of the structure of a first clustering element provided in one embodiment of this application.

[0046] Figure 5 For example Figure 4 The top view of the first clustering element shown.

[0047] Figure 6 This is a schematic diagram of the assembly plan of the first clustering element and the deformation frame provided in one embodiment of this application.

[0048] Figure 7 This is a schematic diagram of the structure of a second clustering element provided in one embodiment of this application.

[0049] Figure 8 For the sake of Figure 7 The top view of the second clustering element shown.

[0050] Figure 9 This is a schematic diagram of the assembly plan of the second cluster element and the deformation frame provided in one embodiment of this application.

[0051] Figure 10 This is a schematic diagram of the flow path of the cooling medium provided in one embodiment of this application.

[0052] Figure 11 This is a schematic diagram of the structure of a radiofrequency ablation catheter provided in another embodiment of this application.

[0053] Figure 12 For example Figure 11 The side view of the radiofrequency ablation catheter shown.

[0054] Figure 13 A schematic diagram of the flow path of the cooling medium provided for another embodiment.

[0055] Figure 14 This is a schematic diagram of the structure of a radiofrequency ablation catheter provided in another embodiment of this application.

[0056] Figure 15 This is a schematic diagram of the structure of a radiofrequency ablation catheter provided in another embodiment of this application.

[0057] Figure 16and Figure 17 This is a schematic diagram showing the usage status of a radiofrequency ablation catheter provided in one embodiment of this application.

[0058] Icon labels:

[0059] 100. Outer sheath; 200. Inner core rod; 300. Ablation assembly; 400. Delivery tube; 500. Blood vessel;

[0060] 1000, Deformation frame; 2000, Ablation electrode assembly;

[0061] 1100, Deformation support rod; 1200, Conveying support rod;

[0062] 1110, First clustering element; 1120, Second clustering element;

[0063] 1110a, First bundle end; 1110b, First bundle support rod;

[0064] 1120a, Second bundle end; 1120b, Second bundle support rod;

[0065] 1120a1, Central through hole; 1120b1, Second medium conveying channel;

[0066] 1200a, Medium Injection Channel;

[0067] 2100. Electrode elements;

[0068] 2100a, Radial ablation energy ring; 2100b, Axial ablation energy ring; 2100c, Medium injection hole;

[0069] 2100d, unit electrode. Detailed Implementation

[0070] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0071] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do 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, and therefore should not be construed as a limitation of this application.

[0072] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0073] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0074] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0075] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0076] To more clearly describe the structure of the ablation components and radiofrequency ablation catheter, the term "distal" is defined herein as the end furthest from the operator during the surgical procedure, and "proximal" as the end closest to the operator during the surgical procedure. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application's specification is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0077] See Figure 1 and Figure 2 As shown in the figure, an ablation assembly 300 is provided in one embodiment of this application. The ablation assembly 300 includes a deformable frame 1000 and an ablation electrode assembly 2000. The deformable frame 1000 has a contracted state and an extended state. The ablation electrode assembly 2000 includes a plurality of electrode elements 2100 distributed on the surface of the deformable frame 1000. In the extended state of the deformable frame 1000, the plurality of electrode elements 2100 can be constructed into a plurality of annular trajectory unit groups and a plurality of linear trajectory unit groups in the axial and circumferential directions of the deformable frame 1000, respectively. The annular trajectory unit groups surround the deformable frame 1000 in the circumferential direction, and the linear trajectory unit groups are linearly distributed in the axial direction of the deformable frame 1000.

[0078] Combination Figures 1 to 3 As shown, when the multiple electrode elements 2100 in the ablation electrode assembly 2000 are arranged on the deformable frame 1000 according to a prescribed pattern, the multiple electrode elements 2100 can form a defined relative positional relationship. As the deformable frame 1000 changes from a contracted state to an extended state, the multiple electrode elements 2100 in the ablation electrode assembly 2000 will form a preset arrangement. This preset arrangement can be represented by a defined arrangement rule in the axial direction of the deformable frame 1000, or it can be represented by a defined arrangement rule in the circumferential direction of the deformable frame 1000. The material of the electrode elements 2100 can be selected as a metal or alloy material with low resistivity and good biocompatibility to improve discharge efficiency, such as gold or platinum-iridium alloy.

[0079] From one perspective, viewed along the axial direction of the deformable frame 1000, the multiple electrode elements 2100 in the ablation electrode assembly 2000 appear to form multiple annular trajectory unit groups along the axial direction of the deformable frame 1000. Each annular trajectory unit group consists of multiple electrode elements 2100 circumferentially surrounding the deformable frame 1000, such that each annular trajectory unit group is circumferentially surrounding the deformable frame 1000. From another perspective, viewed along the circumferential direction of the deformable frame 1000, the multiple electrode elements 2100 in the ablation electrode assembly 2000 appear to form multiple linear trajectory unit groups along the circumferential direction of the deformable frame 1000. Each linear trajectory unit group consists of multiple electrode elements 2100 linearly arranged along the axial direction of the deformable frame 1000, such that each linear trajectory unit group is linearly distributed along the axial direction of the deformable frame 1000. In other words, the multiple annular trajectory unit groups and multiple linear trajectory unit groups mentioned above are not independent of each other, but rather represent different arrangement states of multiple electrode elements 2100 in the ablation electrode group 2000 when viewed from the axial and circumferential directions of the deformable frame 1000.

[0080] Because the multiple electrode elements 2100 in the ablation electrode assembly 2000 are evenly distributed in the circumferential direction of the deformable frame 1000 by means of multiple linear trajectory unit groups, the ablation component 300 can achieve ablation treatment of the blood vessel 500 around its circumference without rotating within the blood vessel 500 during the ablation treatment process. Simultaneously, the multiple electrode elements 2100 in the ablation electrode assembly 2000 are also evenly distributed in the axial direction of the deformable frame 1000 by means of multiple annular trajectory unit groups, so the ablation component 300 can also achieve ablation treatment of a certain length along the axial direction of the blood vessel 500 without moving along the axial direction of the blood vessel 500 during the ablation treatment process. Therefore, it can be seen that the multiple electrode elements 2100 in the ablation electrode assembly 2000 form multiple annular trajectory unit groups and multiple linear trajectory unit groups in the axial and circumferential directions of the deformable frame 1000. As the deformable frame 1000 unfolds, the ablation treatment range in the blood vessel 500 can be greatly expanded. Moreover, axial movement and circumferential rotation are no longer required to achieve treatment over a larger area. This can effectively improve treatment efficiency, reduce operational difficulty, and contribute to the development of ablation treatment technology.

[0081] Continue reading Figure 2 and Figure 3As shown, in one embodiment, after the multiple electrode elements 2100 in the ablation electrode group 2000 form multiple annular trajectory unit groups in the circumferential direction of the deformable frame 1000, each of the multiple annular trajectory unit groups can form a radial ablation energy circle 2100a in the radial direction of the deformable frame 1000. The radial ablation energy circle 2100a can be used to emit energy, so that the radio frequency current flows through the biological tissue. With the help of the rapid change of the electromagnetic field, the polar water molecules in the biological tissue move at high speed, resulting in an endogenous heat effect, causing the water inside and outside the cells to evaporate, dry, shrink and fall off, resulting in aseptic necrosis, thereby achieving the purpose of ablation therapy.

[0082] The adjacent radial ablation energy circles 2100a formed by adjacent annular trajectory unit groups can be defined to be non-overlapping. For example, in one embodiment, the multiple electrode elements 2100 in each annular trajectory unit group can be defined to surround the deformable frame 1000 in a circular trajectory along the circumference, and the plane of each circular trajectory formed by the multiple electrode elements 2100 is perpendicular to the axis of the deformable frame 1000. Therefore, by restricting the arrangement of the multiple electrode elements 2100, it is possible to ensure that the adjacent radial ablation energy circles 2100a do not overlap. This arrangement can ensure that the ablation range can be improved while preventing the occurrence of overlapping areas of excessive ablation, thus avoiding the phenomenon of excessive ablation at the corresponding position. Moreover, the spacing between adjacent electrode elements 2100 in each annular trajectory unit group can also be set to be equidistant. In addition, those skilled in the art can also arrange multiple electrode elements 2100 in various trajectory forms such as square annular trajectory and elliptical annular trajectory according to actual needs to meet the arrangement between the radial ablation energy circles 2100a, which is not limited here.

[0083] Continue reading Figure 2 and Figure 3 As shown, in one embodiment, after the multiple electrode elements 2100 in the ablation electrode group 2000 form multiple linear trajectory unit groups in the axial direction of the deformable frame 1000, each linear trajectory unit group can also form an axial ablation energy ring 2100b in the axial direction of the deformable frame 1000. The radial ablation energy ring 2100a can also be used to emit energy, so that the radio frequency current flows through the biological tissue. With the help of the rapid change of the electromagnetic field, the polar water molecules in the biological tissue move at high speed, resulting in an endogenous heat effect, causing the water inside and outside the cells to evaporate, dry, shrink and fall off, resulting in aseptic necrosis, thereby achieving the purpose of ablation therapy.

[0084] The adjacent axial ablation energy circles 2100b formed by adjacent linear trajectory unit groups can also be defined to be non-overlapping. For example, in one embodiment, the multiple electrode elements 2100 in each linear trajectory unit group can be defined to be distributed in a straight line along the axial direction of the deformable frame 1000, and each straight line trajectory formed by the multiple electrode elements 2100 is parallel to the axis of the deformable frame 1000. Therefore, by restricting the arrangement of the multiple electrode elements 2100, it is possible to ensure that the adjacent axial ablation energy circles 2100b do not overlap. This arrangement can ensure that the ablation range can be improved while preventing the occurrence of overlapping areas of excessive ablation, thus avoiding the phenomenon of excessive ablation at the corresponding position. Moreover, the spacing between adjacent electrode elements 2100 in each linear trajectory unit group can also be set to be equidistant. In addition, those skilled in the art can also arrange multiple electrode elements 2100 in various trajectory forms such as arc-shaped trajectory and wavy trajectory according to actual needs to meet the arrangement between radial ablation energy circles 2100a, which is not limited here.

[0085] Of course, those skilled in the art can also, during the uniform arrangement of adjacent radial ablation energy rings 2100a and adjacent axial ablation energy rings 2100b, ensure that some or all of the adjacent radial ablation energy rings 2100a overlap to a certain extent, and similarly, ensure that some or all of the adjacent axial ablation energy rings 2100b overlap to a certain extent. The overlapping areas can form stimulation between the electrode elements 2100, forming a stimulation circuit, thereby helping the operator to find the target treatment area and improve the accuracy of ablation. This allows the ablation electrode assembly 2000 on the deformable frame 1000 to form an integrated stimulation and ablation function. Regarding the specific degree of overlap, those skilled in the art can make appropriate adjustments based on various factors such as the required degree of stimulation and the size of the deformable frame 1000, so that although overlapping areas are formed in adjacent radial ablation energy circles 2100a and adjacent axial ablation energy circles 2100b, excessive ablation will not occur. A balance is sought between excessive ablation and electrode stimulation, and no specific limitations are made here.

[0086] For example, in one embodiment, each annular trajectory unit group forms a radial ablation energy ring 2100a in the radial direction of the deformable frame 1000. Between adjacent radial ablation energy rings 2100a formed by adjacent annular trajectory unit groups, a portion of the adjacent radial ablation energy rings 2100a may overlap, or all adjacent radial ablation energy rings 2100a may overlap. The overlap can occur by having multiple electrode elements 2100 in each annular trajectory unit group surround the deformable frame 1000 in a circular trajectory along its circumference, with at least some adjacent circular trajectories forming an angle between their planes. This overlap between adjacent circular trajectories causes the adjacent radial ablation energy rings 2100a formed by the multiple electrode elements 2100 arranged in adjacent circular trajectories to overlap. In addition, those skilled in the art can achieve overlap between adjacent radial ablation energy rings 2100a in other ways according to actual needs, which are not limited here.

[0087] For example, in one embodiment, each linear trajectory unit group forms an axial ablation energy circle 2100b along the axial direction of the deformable frame 1000. Between adjacent axial ablation energy circles 2100b formed by adjacent linear trajectory unit groups, some adjacent axial ablation energy circles 2100b may overlap, or all adjacent axial ablation energy circles 2100b may overlap. The overlap can occur by having multiple electrode elements 2100 in each linear trajectory unit group arranged in a straight line along the axial direction of the deformable frame 1000, with at least some adjacent straight lines forming an angle. The intersection of these adjacent straight lines causes the adjacent axial ablation energy circles 2100b formed by the multiple electrode elements 2100 arranged in the adjacent straight lines to overlap. In addition, those skilled in the art can achieve overlap between adjacent axial ablation energy circles 2100b in other ways according to actual needs, which are not limited here.

[0088] The deformable frame 1000 can be adopted in various frame forms; please refer to further details. Figure 1 As shown, in one embodiment, the deformable frame 1000 includes a plurality of deformable support rods 1100 and a first bundled element 1110 and a second bundled element 1120 for connecting the plurality of deformable support rods 1100. The deformable support rods 1100 can be pre-formed into a specific shape, for example, the plurality of deformable support rods 1100 can be arranged to be spirally wound circumferentially along the axial direction, see reference. Figure 1As shown. The deformable support rod 1100 can be made of polymer or shape memory alloy materials with good shape change and recovery capabilities. Polymer materials can be PEBAX, TPU, etc., while shape memory alloy materials can be nickel-titanium alloy, stainless steel, or titanium, etc. For example, the deformable support rod 1100 can be a combination of nickel-titanium alloy and polymer tubing. The linear length of the deformable support rod 1100 can be set between 20mm and 80mm. The first clustering element 1110 is connected to the distal ends of multiple deformable support rods 1100, and the second clustering element 1120 is connected to the proximal ends of multiple deformable support rods 1100, so that the two ends of multiple deformable support rods 1100 are connected, forming a shrinkable and expandable support structure. Multiple electrode elements 2100 of the ablation electrode assembly 2000 can be mounted on multiple deformable support rods 1100, so that the multiple electrode elements 2100 can be constructed into multiple annular trajectory unit groups and multiple linear trajectory unit groups in the axial and circumferential directions, respectively, which will not be elaborated here.

[0089] To effectively reduce the temperature between the ablation electrode assembly 2000 and the inner wall of the blood vessel 500, thereby further increasing the ablation depth, in one embodiment, the electrode element 2100 may have a corresponding media infusion port 2100c, which can be used to deliver cooling media. Because without deep ablation, the ablation site cannot achieve the desired ablation effect, but deep ablation may also pose a risk of damaging healthy tissue, it is necessary to specifically reduce the temperature at the ablation site to ensure that the inner wall of the blood vessel 500 is not damaged, thereby increasing the ablation depth and achieving a good therapeutic effect.

[0090] The cooling medium can be a saline solution, etc. One or more medium infusion holes 2100c are opened on the electrode element 2100 as needed. The surgeon can connect to the medium infusion hole 2100c on the electrode element 2100 through the delivery tube 400. For example, one end of the delivery tube 400 is located outside the biological body, and the other end of the delivery tube 400 is connected to the medium infusion hole 2100c on the electrode element 2100 through direct or indirect connection. The surgeon delivers the cooling medium into the delivery tube 400 outside the biological body and delivers the cooling medium to the medium infusion hole 2100c of the electrode element 2100 through the delivery tube 400. The cooling medium is applied to the target position through the medium infusion hole 2100c to reduce the temperature at the ablation site.

[0091] After the delivery pipe 400 is connected to the medium injection hole 2100c in the electrode element 2100, a channel from the outside to the inside can be formed. This channel may only include the delivery pipe 400 and the medium injection hole 2100c, or it may include other channels or holes opened on the deformation frame 1000 for delivering cooling medium. This needs to be determined according to the arrangement of the electrode element 2100 on the deformation frame 1000, and is not limited here. For example, in one embodiment, a wire delivery channel may be opened in the deformation support rod 1100 along the length of the rod. The wire delivery channel is used to pass through the energy delivery wire, which is used to connect the electrode element 2100 to deliver energy from outside the organism to inside the organism, serving as an energy transmission structure. In addition, a first medium delivery channel can be opened inside the deformable support rod 1100 along the length of the rod. The first medium delivery channel is used to deliver cooling medium. At this time, the delivery pipe 400 can be connected with the first medium delivery channel. The first medium delivery channel is connected with the medium injection hole 2100c on the electrode element 2100, so that the delivery pipe 400, the first medium delivery channel and the medium injection hole 2100c in the electrode element 2100 are connected together to form a channel from the outside to the inside, delivering cooling medium from outside the biological body to the inside.

[0092] See Figures 4 to 6 As shown, the first clustering element 1110 includes a first clustering end 1110a and a plurality of first clustering support rods 1110b. The first clustering end 1110a is clustered and connected to the distal ends of the plurality of first clustering support rods 1110b. The number of first clustering support rods 1110b is the same as the number of deformable support rods 1100. The proximal end of each first clustering support rod 1110b is connected to the distal end of a deformable support rod 1100. The distal end of the first clustering end 1110a may have a rounded chamfer, and its material may be selected to have certain imaging properties and good biocompatibility, such as gold or platinum-iridium alloy. The proximal end of the first clustering support rod 1110b may also have a smooth chamfer, so that it does not damage the inner wall of the blood vessel 500 during its contact with the inner wall of the blood vessel 500. The first clustering end 1110a and the plurality of first clustering support rods 1110b can be integrally formed or manufactured separately and then assembled.

[0093] The first cluster support rod 1110b can be pre-formed into a specific shape, such as a claw-shaped structure extending uniformly in the radial direction. The outer contour diameter formed by the plurality of first cluster support rods 1110b in the first cluster element 1110 gradually increases from the distal end to the proximal end of the first cluster element 1110, so that the first cluster element 1110 can form an umbrella-like outer contour shape, which facilitates connection with a deformable support that can deform at any time. The outer diameter of the first cluster support rod 1110b and the deformable support rod 1100 can be set to be the same, or the outer diameter of the first cluster support rod 1110b can be slightly larger than the outer diameter of the deformable support rod 1100, as long as good connectivity between the two is ensured.

[0094] See Figures 7 to 9 As shown, the second clustering element 1120 includes a second clustering end 1120a and a plurality of second clustering support rods 1120b. The second clustering end 1120a is connected to the proximal ends of the plurality of second clustering support rods 1120b in a clustered manner. The number of second clustering support rods 1120b is the same as the number of deformable support rods 1100. The distal end of each second clustering support rod 1120b is connected to the proximal end of a deformable support rod 1100. The distal end of the second clustering end 1120a may have a rounded chamfer, and its material may be selected to have certain imaging properties and good biocompatibility, such as gold or platinum-iridium alloy. The proximal ends of the second clustering support rods 1120b may also have smooth chamfers to prevent damage to the inner wall of the blood vessel 500 during their contact with the inner wall. The second clustering end 1120a and the plurality of second clustering support rods 1120b can be integrally formed or manufactured separately and then assembled.

[0095] The second cluster support rod 1120b can be pre-formed into a specific shape, such as a claw-shaped structure extending uniformly in the radial direction. The outer contour diameter formed by the plurality of second cluster support rods 1120b in the second cluster element 1120 gradually increases from the proximal end to the distal end of the second cluster element 1120, so that the second cluster element 1120 can form an umbrella-like outer contour shape, which facilitates connection with a deformable support rod that can deform at any time. The outer diameter of the second cluster support rod 1120b and the deformable support rod 1100 can be set to be the same, or the outer diameter of the second cluster support rod 1120b can be slightly larger than the outer diameter of the deformable support rod 1100, as long as good connectivity between the two is ensured.

[0096] The number of the first cluster support rod 1110b and the second cluster support rod 1120b can be set from 4 to 24, depending on the actual situation. The materials of the first cluster support rod 1110b and the second cluster support rod 1120b can be selected from polymer or shape memory alloy materials with good shape change and recovery capabilities. Polymer materials can be selected from PEBAX, TPU, etc., while shape memory alloy materials can be selected from nickel-titanium alloys, stainless steel, or titanium, etc.

[0097] At least one of the first bundle end 1110a and the second bundle end 1120a has a central through hole 1120a1. The interior of the central through hole 1120a1 may be coated with a hydrophilic and slippery coating to reduce the movement resistance of the inner core rod 200. The hydrophilic and slippery coating is preferably PTFE or PFA. In particular, when the inner core rod 200 passes through the central axis of the deformation bracket, the second bundle end 1120a must have a central through hole 1120a1 to allow the inner core rod 200 to pass through the central through hole 1120a1 of the second bundle end 1120a and through the interior of the deformation bracket to form a connection with the first bundle end 1110a. The first bundle end 1110a may also optionally have a central through hole 1120a1 to facilitate the insertion of the distal end of the inner core rod 200 into the first bundle end 1110a, and can be further fixed by welding or adhesive bonding. At least one of the first cluster support rod 1110b and the second cluster support rod 1120b may be selected as an elastic rod with elastic effect.

[0098] Continue reading Figure 8 and Figure 9 As shown, in one embodiment, a second medium delivery channel 1120b1 may also be provided inside the second cluster support rod 1120b. The second medium delivery channel 1120b1 is used to deliver cooling medium. In this case, the delivery pipe 400 can communicate with the second medium delivery channel 1120b1, and the second medium delivery channel 1120b1 can communicate with the first medium delivery channel. Then, the first medium delivery channel communicates with the medium injection hole 2100c on the electrode element 2100, so that the delivery pipe 400, the second medium delivery channel 1120b1, the first medium delivery channel, and the medium injection hole 2100c in the electrode element 2100 are all connected to form a channel from the outside to the inside, delivering cooling medium from outside the biological body to the inside. See reference. Figure 10 As shown, the cooling medium outside the biological body, such as saline solution, can first enter through the delivery pipe 400, flow along the second medium delivery channel 1120b1, enter the first medium delivery channel, and finally be ejected through the medium injection hole 2100c on the electrode element 2100. The flow direction of the cooling medium is... Figure 10 The flow direction is shown in ①→②→③→④.

[0099] Continue reading Figure 11 and Figure 12 As shown, in one embodiment, the deformable frame 1000 may further include a conveying support rod 1200, and a medium injection channel 1200a is formed within the conveying support rod 1200. The medium injection channel 1200a is used to convey the cooling medium, instead of using the electrode elements 2100 for injection. The number of medium injection channels 1200a and the number of channel outlets of each medium injection channel 1200a can be set according to requirements. For example, the number of channel outlets can be set to be the same as the number of electrode elements 2100, so that each channel outlet corresponds to one electrode element 2100, ensuring that the ablation position of each electrode element 2100 can be specifically cooled.

[0100] See Figure 13 As shown, at this time, the delivery pipe 400 can be directly connected to the medium filling channel 1200a inside the delivery support rod 1200, eliminating the need for the first medium delivery channel, the second medium delivery channel 1120b1, and the medium filling hole 2100c in the electrode element 2100. Since the electrode element 2100 is only used for the release of radio frequency energy, it does not require the medium filling hole 2100c, thus simplifying the component manufacturing process. The deformable support rod 1100 can also be configured as a simple single-cavity structure, requiring only a wire delivery channel for threading the energy delivery wire, effectively reducing the manufacturing difficulty of the component. The extracellular cooling medium, such as saline solution, can first enter through the delivery pipe 400, flow along the medium filling channel 1200a, and finally exit through the channel outlet of the medium filling channel 1200a, applying cooling medium to the corresponding position of the electrode element 2100. The flow direction of the cooling medium is... Figure 13 The flow direction is shown in ①→②→③→④.

[0101] Continue reading Figure 11 and Figure 12 As shown, the number of conveying support rods 1200 can be set according to requirements; for example, the number of conveying support rods 1200 can be the same as the number of deformation support rods 1100. Furthermore, multiple conveying support rods 1200 can also be spirally wound circumferentially along the axial direction, so that both the conveying support rods 1200 and the deformation support rods 1100 maintain the same spiral winding shape, constructing a shrinkable and expandable deformation frame 1000. Each conveying support rod 1200 can correspond to one deformation support rod 1100, and the number of channel outlets on each conveying support rod 1200 is the same as and corresponds to the number of electrode elements 2100 on the corresponding deformation support rod 1100. The conveying support rods 1200 can be constructed inside the deformation support rods 1100, for example... Figure 11 and Figure 12As shown, when the deformable frame 1000 is in the unfolded state, the maximum expansion outer diameter D1 of the multiple conveying support rods 1200 spiraling circumferentially is smaller than the maximum expansion outer diameter D of the multiple deformable support rods 1100 spiraling circumferentially.

[0102] The electrode element 2100 in the ablation electrode assembly 2000 can have various structures and shapes, as long as it can be stably installed and arranged on the deformation frame 1000. For example, in one embodiment, the electrode element 2100 can be selected as a sleeve-shaped element with through-hole cavities at both ends, so that the electrode element 2100 can be adapted to the deformation frame 1000 composed of deformation support rods 1100 and sleeved onto the deformation support rods 1100 using the sleeve cavity. Moreover, see... Figure 14 and Figure 15 As shown, the electrode element 2100 may include at least two unit electrodes 2100d. At least one of the unit electrodes 2100d is a radio frequency signal receiving electrode, and the remaining unit electrodes 2100d are radio frequency signal transmitting electrodes. The electrode element 2100 thus formed can help locate the target treatment area through mutual stimulation between the radio frequency signal receiving electrode and the radio frequency signal transmitting electrode, forming an integrated stimulation and ablation. The spacing between the radio frequency signal receiving electrode and the radio frequency signal transmitting electrode can be limited to between 0.5 mm and 1 mm.

[0103] When the target treatment area is determined, the radiofrequency signal receiving electrode and the radiofrequency signal transmitting electrode in the electrode element 2100 can be ablated simultaneously or partially to complete the treatment of the target area. With the cooperation of the radiofrequency signal receiving electrode and the radiofrequency signal transmitting electrode, the operator can stimulate the target treatment area before ablation. When the radiofrequency ablation catheter enters the blood vessel 500, the ablation component 300 can be adjusted to fit closely against the inner wall of the blood vessel 500, stimulating the target treatment area first to find a suitable treatment zone and improve the accuracy of ablation.

[0104] Continue reading Figure 1 and Figure 2As shown, this application provides a radiofrequency ablation catheter, which includes an outer sheath 100, an inner core 200, and an ablation component 300. In addition, the radiofrequency ablation catheter may also include other adaptable components such as a handle, a perfusion system, and an energy delivery system (not shown in the figure). The outer sheath 100 may be made of a hybrid material of polymer and metal with a braided structure, possessing certain resistance to torsion and a certain degree of rigidity. The handle may be equipped with an adjustment button (not shown in the figure), which is used to control the axial movement of the inner core 200, thereby adjusting the axial stretching and compression length of the ablation component 300. This allows control over the profile size of the ablation component 300 and the real-time switching between the deployed and contracted states of the ablation component 300, facilitating movement and applicability within the blood vessel 500 for treatment.

[0105] The outer sheath 100 has an axially penetrating inner cavity. The inner core rod 200 is movably fitted within the inner cavity of the outer sheath 100. The ablation component 300 is disposed at the distal end of the outer sheath 100, and the proximal end of the outer sheath 100 can be connected to components such as a handle for gripping. The inner core rod 200 is connected to the deformable frame 1000 of the ablation component 300. For example, the distal end of the inner core rod 200 is connected to the distal end of the ablation component 300, while the proximal end of the inner core rod 200 penetrates the interior of the ablation component 300 and is connected to an adjustment button located within the handle. By controlling the adjustment button, the inner core rod 200 moves axially, applying a force to the deformable frame 1000, thus controlling the deformation frame 1000 to switch between a contracted state and an extended state. The inner core rod 200 can be made of a metal material with a certain degree of hardness and good biocompatibility, such as nickel-titanium alloy or biocompatible stainless steel. The outer surface of the inner core rod 200 may be coated with a hydrophilic and slippery coating to reduce the movement resistance of the inner core rod 200. The hydrophilic and slippery coating may preferably be PTFE or PFA.

[0106] Continue reading Figure 3 As shown, when the ablation assembly 300 of the radiofrequency ablation catheter is in the deployed state, the multiple electrode elements 2100 in the ablation electrode group 2000 are uniformly distributed in both the axial and circumferential directions, with appropriate spacing between them. Input energy can cause the multiple electrode elements 2100 to operate, such as... Figure 3As shown, the ablation electrode assembly 2000 simultaneously forms four axial ablation energy coils 2100b and four radial ablation energy coils 2100a in both radial and axial directions. The four axial ablation energy coils 2100b and four radial ablation energy coils 2100a do not overlap, thus ensuring that when the ablation component 300 is at its maximum expanded outer diameter, the ablation electrode assembly 2000 has appropriate energy release spacing in both the axial and radial directions, preventing excessive overlap of released radiofrequency energy and avoiding damage to the inner wall of the blood vessel 500. This structure allows the radiofrequency ablation catheter to effectively improve energy distribution, cover a wider treatment area, facilitate operator manipulation, and reduce the difficulty of surgical treatment.

[0107] In some other embodiments, the axial ablation energy coils 2100b and radial ablation energy coils 2100a may also have a certain degree of overlap, forming mutual stimulation by the closely spaced electrode elements 2100, which is more conducive to finding the target for treatment. In this embodiment, the closely spaced electrode elements 2100 may also be selected to work at different times, thereby avoiding excessive energy overlap and avoiding damage to the inner wall of the blood vessel 500.

[0108] See Figure 16 and Figure 17 As shown, during the procedure, when the radiofrequency ablation catheter needs to enter the blood vessel 500 or when the treatment area needs to be changed, the shape of the ablation component 300 can be adjusted from an extended state to a contracted state. At this time, the ablation component 300 of the radiofrequency ablation catheter can be in a near-linear state, which facilitates the entry of the radiofrequency ablation catheter into the blood vessel 500 or its movement and adjustment within the blood vessel 500. When the target treatment area is reached, the ablation component 300 is gradually adjusted back to the extended state, ensuring good contact between the ablation component 300 and the blood vessel 500. At this point, the perfusion system or energy system can be activated to begin ablation treatment on the target treatment area.

[0109] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0110] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An ablation component, characterized in that, The ablation component includes: A deformable frame, which has a contracted state and an extended state; An ablation electrode assembly includes at least three electrode elements distributed on the surface of the deformable frame. When the deformable frame is in its unfolded state, viewed from the axial direction, the electrode elements form multiple annular trajectory unit groups in the axial direction; viewed from the circumferential direction, the electrode elements form multiple linear trajectory unit groups in the circumferential direction. The annular trajectory unit groups surround the deformable frame circumferentially, and the linear trajectory unit groups are linearly distributed along the axial direction of the deformable frame. Multiple deformable support rods, all of which are spirally wound circumferentially along the axial direction, and multiple electrode elements of the ablation electrode group are disposed on the multiple deformable support rods, such that the multiple electrode elements can be constructed into multiple ring trajectory unit groups and multiple linear trajectory unit groups in the axial and circumferential directions, respectively. A first clustering element is connected to the distal ends of the plurality of deformable support rods; The second clustering element is connected to the proximal clustering of the plurality of deformable support rods.

2. The ablation component according to claim 1, characterized in that, Each of the aforementioned annular trajectory unit groups forms a radial ablation energy circle in the radial direction of the deformed frame, and adjacent radial ablation energy circles formed by adjacent annular trajectory unit groups do not overlap; and / or Each of the linear trajectory unit groups forms an axial ablation energy circle along the axial direction of the deformed frame, and the adjacent axial ablation energy circles formed by adjacent linear trajectory unit groups do not overlap.

3. The ablation component according to claim 2, characterized in that, The multiple electrode elements in each of the circular trajectory unit groups are arranged in a circular trajectory along the circumference of the deformable frame, and the plane of the circular trajectory is perpendicular to the axis of the deformable frame; And / or, The spacing between adjacent electrode elements in each of the said annular trajectory unit groups is the same; and / or The multiple electrode elements in each linear trajectory unit group are distributed along the axial direction of the deformable frame in a straight trajectory, and the straight trajectory is parallel to the axis of the deformable frame; And / or, The spacing between adjacent electrode elements in each linear trajectory unit group is the same.

4. The ablation component according to claim 1, characterized in that, Each of the aforementioned annular trajectory unit groups forms a radial ablation energy circle in the radial direction of the deformed frame, and at least partially adjacent radial ablation energy circles formed by adjacent annular trajectory unit groups overlap; and / or, Each of the linear trajectory unit groups forms an axial ablation energy circle in the axial direction of the deformed frame, and at least some of the adjacent axial ablation energy circles formed by adjacent linear trajectory unit groups overlap.

5. The ablation component according to claim 4, characterized in that, Each of the plurality of electrode elements in each of the said annular trajectory unit groups is arranged in a circular trajectory along the circumference of the deformable frame, and at least some of the planes containing the adjacent annular trajectories have an included angle; and / or The plurality of electrode elements in each linear trajectory unit group are distributed along the axial direction of the deformable frame in a straight trajectory, with at least some of the adjacent straight trajectories having an included angle.

6. The ablation component according to claim 1, characterized in that, The electrode element has a medium filling hole, which is used to deliver cooling medium.

7. The ablation component according to claim 1, characterized in that, The deformable support rod has at least one of a wire delivery channel and a first medium delivery channel, wherein the wire delivery channel is used to thread an energy delivery wire, the energy delivery wire is used to connect the electrode element, and the first medium delivery channel is used to deliver a cooling medium; and / or, The first clustering element includes a first clustering end and a plurality of first clustering support rods. The first clustering end is clustered and connected to the distal ends of the plurality of first clustering support rods. The number of first clustering support rods is the same as the number of deformation support rods. The proximal end of each first clustering support rod is connected to the distal end of one of the deformation support rods; and / or, The second clustering element includes a second clustering end and a plurality of second clustering support rods. The second clustering end is connected to the proximal ends of the plurality of second clustering support rods in a clustering manner. The number of second clustering support rods is the same as the number of deformation support rods. The distal end of each second clustering support rod is connected to the proximal end of one of the deformation support rods.

8. The ablation component according to claim 7, characterized in that, The second bundle support rod has a second medium conveying channel, which is used to convey cooling medium; and / or, At least one of the first bundle end and the second bundle end has a central through hole, the central through hole being used to pass through the inner core rod; and / or, At least one of the first and second bundle support rods is an elastic rod; and / or, The outer diameter of the plurality of first bundle support rods in the first bundle element gradually increases in the direction from the distal end to the proximal end of the first bundle element; and / or, The outer diameter of the plurality of second bundle support rods in the second bundle element gradually increases in the direction from the proximal end to the distal end of the second bundle element.

9. The ablation component according to claim 1, characterized in that, The deformable frame includes: A conveying support rod is provided, and a medium filling channel is provided inside the conveying support rod for conveying cooling medium.

10. The ablation component according to claim 9, characterized in that, The number of channel outlets in the medium infusion channel is the same as the number of electrode elements, with each channel outlet corresponding to one electrode element; or... The number of conveying support rods is the same as the number of deformation support rods. All of the conveying support rods are spirally wound around the axial direction. Each conveying support rod corresponds to one deformation support rod. The number of channel outlets on each conveying support rod is the same as and corresponds to the number of electrode elements on the corresponding deformation support rod.

11. The ablation component according to claim 1, characterized in that, The electrode element is a sleeve-shaped element with a through-hole at both ends, and the electrode element is sleeved on the deformable support rod; and / or, The electrode element comprises at least two unit electrodes, at least one of which is a radio frequency signal receiving electrode, and the remaining unit electrodes are radio frequency signal transmitting electrodes.

12. A radiofrequency ablation catheter, characterized in that, The radiofrequency ablation catheter includes: An outer sheath having an axially penetrating inner cavity; An inner core rod, which is movably assembled within the inner cavity of the outer sheath tube; The ablation assembly as described in any one of claims 1-11, wherein the ablation assembly is disposed at the distal end of the outer sheath, and the inner core rod is connected to the deformation frame of the ablation assembly for controlling the deformation frame to switch between the contracted state and the deployed state.

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