Ablation device and ablation catheter thereof

Abstract

The present application discloses an ablation device and an ablation catheter thereof, the ablation catheter comprising: a tubular member, which is flexible and has an operating end and a working end; a main control shaft, which is slidably disposed in the tubular member; an ablation component, which is flexible and slidably disposed in the tubular member, the ablation component having an ablation element bearing portion made of shape memory material, the ablation element bearing portion bearing a plurality of ablation elements, the ablation component being able to contract in the tubular member under the drive of the main control shaft to maintain a linear extension state and being able to extend from the working end of the tubular member so that the ablation element bearing portion presents a radially expanded portion, the ablation catheter comprising: at least one auxiliary control shaft, which is slidably disposed in the tubular member, the auxiliary control shaft being fixedly connected to the ablation element bearing portion of the ablation component so as to slide along the main control shaft under the drive of the auxiliary control shaft.

Description

[0001] This application is a divisional application of the Chinese invention patent application with application number 202111224530.0, application date October 21, 2021, Chinese priority application number 202111070759.3, and priority date September 13, 2021. Technical Field

[0002] The present application relates to the field of ablation, and more particularly, to an ablation catheter for performing ablation treatment on a tissue object to be treated and an ablation device comprising the ablation catheter. Background Art

[0003] Ablation is the process of inserting a catheter into the tissue to be treated, and then using the catheter's electrodes to apply energy to the tissue, thereby selectively killing cells in certain areas. Ablation has a wide range of indications, such as solid tumors and atrial fibrillation.

[0004] When using ablation to treat atrial fibrillation, the end of the catheter is delivered to the target location of the heart through vascular puncture, and then discharge ablation is performed. The purpose of treatment is achieved by correcting the abnormal conduction path of the heart's electrical signals.

[0005] The ablation device is a device for ablation treatment, which generally includes an electrode with a built-in ablation catheter, a control handle connected to the ablation catheter for controlling the electrode, and a controller electrically connected to the electrode for controlling electric pulses. When working, the electrode built into the ablation catheter is extended from the catheter and attached to the tissue site to be treated. It usually has to perform the task of detecting bioelectric parameters and then perform the task of applying energy to the target site. In between, the position of the electrode often needs to be adjusted to achieve the best treatment effect. However, at present, although the industry has proposed many structural forms of ablation catheters, most traditional ablation catheters cannot conveniently and flexibly adjust the relative positions of electrodes; even if they have an adjustment function, the adjustment range is not controlled and precise adjustment cannot be achieved.

[0006] Therefore, how to obtain an ablation device solution with a high degree of freedom in its relative position with respect to the tissue site to be treated during operation has become a technical problem that needs to be solved in the art. Summary of the invention

[0007] In view of this, the present application proposes an ablation device and an ablation catheter thereof, so as to achieve a high degree of freedom in the relative position relative to the tissue site to be treated during operation.

[0008] According to one aspect of the present application, an ablation catheter is proposed, which includes: a tubular member, which is flexible and has an operating end and a working end; a main control shaft, which is slidably disposed in the tubular member; an ablation component, which is flexible and slidably disposed in the tubular member, and the ablation component has an ablation element bearing portion made of shape memory material, the ablation element bearing portion bearing a plurality of ablation elements arranged at intervals from each other, and the ablation component can be retracted in the tubular member under the drive of the main control shaft to maintain a linear extension state and can extend from the working end of the tubular member so that the ablation element bearing portion presents at least one radial expansion portion; the ablation catheter includes: at least one auxiliary control shaft, which is slidably disposed in the tubular member, and the auxiliary control shaft is fixedly connected to the ablation element bearing portion of the ablation component so as to slide along the main control shaft under the drive of the auxiliary control shaft.

[0009] Preferably, when the ablation assembly is extended from the working end of the tubular member, the auxiliary control shaft can adjust the radial expansion degree of the at least one radial expansion portion by sliding the ablation element bearing portion relative to the main control shaft.

[0010] Preferably, the radial expansion portion is in a spiral shape; and / or when viewed from the axial direction of the main control shaft, the radial expansion portion is in a circular shape with the main control shaft as the center.

[0011] Preferably, the end of the main control shaft is fixedly connected to the end of the ablation element bearing portion, and a sliding member is fixedly provided on the ablation element bearing portion. The sliding member is slidably provided on the main control shaft and fixedly connected to the auxiliary control shaft.

[0012] Preferably, when the ablation assembly is extended from the working end of the tubular member, the ablation element carrying portion is divided into a first expansion portion and a second expansion portion by the sliding member.

[0013] Preferably, the end of the ablation element bearing part is slidably disposed in the end region of the main control shaft, the auxiliary control shaft is fixedly connected to the end of the ablation element bearing part, and the ablation element bearing part is fixedly connected to the main control shaft via a fixing member.

[0014] Preferably, when the ablation assembly is extended from the working end of the tubular member, the ablation element bearing portion is divided into a first expansion portion and a second expansion portion by the fixing member.

[0015] Preferably, the sliding fit is achieved through a sliding structure such as a sliding groove or an axial hole.

[0016] Preferably, the sliding fit has a predetermined sliding range.

[0017] Preferably, when the ablation assembly is extended from the working end of the tubular member, the first expansion portion which is farther from the working end of the tubular member in the axial direction expands less in the radial direction than the second expansion portion.

[0018] Preferably, the ablation element is used to detect electrical signals of the tissue to be treated when in operation; and / or to provide at least one of acoustic energy, electrical and / or magnetic energy, thermal energy, chemical energy, and radiation energy.

[0019] Preferably, the ablation element is an electrode.

[0020] Preferably, when the ablation assembly is extended from the working end of the tubular member, the plurality of electrodes distributed on at least one radially expanded portion are used to form a circumferential electric field and / or an axial electric field.

[0021] According to another aspect of the present application, an ablation catheter is provided, which includes: a tubular member, which is flexible and has an operating end and a working end; a plurality of control shafts, which are independently and parallelly arranged in the tubular member and can be slidably arranged; a plurality of ablation components, each ablation component is flexible and has an ablation element bearing portion made of shape memory material, the ablation element bearing portion carries a plurality of ablation elements arranged at intervals from each other, each ablation component is connected to its own control shaft and can be retracted in the tubular member under the drive of the control shaft to maintain a linear extension state and can extend from the working end of the tubular member so that the ablation element bearing portion presents a radially expanded portion.

[0022] Preferably, in a state where the ablation components are extended from the working end of the tubular member, different ablation components extend to different degrees in the axial direction.

[0023] Preferably, when the ablation assembly is extended from the working end of the tubular member, the radial expansion portions of different ablation assemblies have different expansion degrees in the radial direction.

[0024] Preferably, in a state where the ablation component is extended from the working end of the tubular member, the radially expanded portion of the ablation component, which extends farther in the axial direction, has a smaller degree of expansion in the radial direction.

[0025] Preferably, the ablation catheter comprises a sliding guide, which is provided on the multiple control shafts and is used to guide the multiple control shafts to slide in sliding directions parallel to each other.

[0026] Preferably, each control shaft is slidably disposed on the sliding guide; or at least one control shaft among the plurality of control shafts is fixed to the sliding guide and at least one control shaft is slidably disposed on the sliding guide.

[0027] Preferably, the sliding fit is achieved by a sliding structure such as a sliding groove or an axial hole. Preferably, the sliding fit has a predetermined sliding range.

[0028] Preferably, the radial expansion portion is in a spiral shape; and / or when viewed from the axial direction of the control shaft, the radial expansion portion is in a circular shape.

[0029] Preferably, the ends of the respective ablation element carrying parts are fixedly connected to each other.

[0030] Preferably, the ablation catheter comprises a telescopic control shaft, which is slidably disposed in the tubular member and is fixedly connected to the ends of the ablation element bearing parts.

[0031] Preferably, the ends of the respective ablation element carrying parts are slidably connected to each other within a predetermined sliding range.

[0032] Preferably, the ablation catheter comprises a telescopic control shaft, which is slidably disposed in the tubular member and fixedly connected to the end of the ablation element bearing portion that protrudes the farthest outward from the tubular member.

[0033] Preferably, the ablation component includes a first ablation component having a first ablation element carrying portion and a second ablation component having a second ablation element carrying portion. When the ablation component is extended from the working end of the tubular member, the first ablation element carrying portion extends outward from the tubular member farther than the second ablation element carrying portion. The end of the first ablation element carrying portion and the end of the second ablation element carrying portion are slidably matched within a predetermined sliding range, and the telescopic control shaft is fixedly connected to the end of the first ablation element carrying portion.

[0034] Preferably, the ablation element is used to detect electrical signals of the tissue to be treated when in operation; and / or to provide at least one of acoustic energy, electrical and / or magnetic energy, thermal energy, chemical energy, and radiation energy.

[0035] Preferably, the ablation element is an electrode.

[0036] Preferably, when the ablation assembly is extended from the working end of the tubular member, the multiple electrodes distributed on the radially expanded portion of each ablation assembly are used to form a circumferential electric field and / or an axial electric field.

[0037] According to another aspect of the present application, an ablation device is provided, which includes an ablation catheter, a control handle connected to the ablation catheter, and a controller electrically connected to the ablation catheter. The ablation catheter is the ablation catheter provided in the present application.

[0038] According to the technical solution of the present application, by setting at least one auxiliary control shaft, the auxiliary control shaft is fixedly connected to the ablation element bearing part of the ablation component, and the auxiliary control shaft can be used to drive the ablation element bearing part to slide along the main control shaft. Therefore, when the ablation component is extended from the working end of the tubular member, the auxiliary control shaft can adjust the radial expansion degree of the at least one radial expansion part by making the ablation element bearing part slide relative to the main control shaft, thereby achieving a higher degree of freedom in the relative position relative to the tissue part to be treated.

[0039] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The accompanying drawings constituting a part of the present application are used to provide a further understanding of the present application, and the schematic implementation modes and descriptions of the present application are used to explain the present application. In the accompanying drawings:

[0041] Figures 1 to 3 A structural schematic reference diagram of an ablation catheter according to a preferred embodiment of the present application;

[0042] Figures 4 to 7 This is a schematic structural reference diagram of an ablation catheter according to other different embodiments of the present application. DETAILED DESCRIPTION

[0043] Ablation can be used for a variety of medical purposes, such as ablation of cancerous tissue, ablation of nerve tissue, ablation of atrial fibrillation, etc. For the sake of simplicity, this application mainly describes the technical solution of this application by taking the application scenario of treating atrial fibrillation as an example, but it should be pointed out that the technical solution of this application is not limited to the ablation application scenario of treating atrial fibrillation, but also covers other suitable application scenarios.

[0044] The basic procedure of ablation for the treatment of atrial fibrillation is as follows: under the guidance of medical images, the ablation catheter is guided to the predetermined position in the heart (such as the connection between the pulmonary vein and the heart), the electrode in the ablation catheter is extended and contacts the target site (such as myocardial cells and / or vascular lining cells), and then the electrode releases high-frequency current, thereby causing cell necrosis in a very small specific range, thereby improving the electrical signal conduction circuit and achieving the treatment purpose.

[0045] Most traditional ablation catheters cannot conveniently and flexibly adjust the relative position between electrodes, which may lead to unsatisfactory treatment effects. In order to allow the relative position of the ablation catheter to the tissue to be treated to have a high degree of freedom during operation, the present application provides an ablation device, which includes an ablation catheter, a control handle connected to the ablation catheter, and a controller electrically connected to the ablation catheter. The operator can control the position, posture, and whether the electrode is deployed of the ablation catheter entering the human body through the control handle; the working state of the electrode (ablation element) can be controlled by the controller.

[0046] In this application, the improved technical solutions are mainly proposed for ablation catheters, so the structure of the ablation catheter and its working process will be described in detail; while for other parts (such as control handles, controllers, etc.), the description is simplified, and technical personnel in this field can refer to the corresponding parts of the existing ablation devices.

[0047] The technical solution of the present application will be described in detail below in conjunction with the drawings in the specification to achieve a full disclosure. It is understood that the technical contents described in the specification and its drawings are only used to exemplarily explain the technical solution of the present application, and do not limit the scope of protection of the technical solution claimed by the present application.

[0048] 1. Implementation Method 1

[0049] Figures 1 to 3 The ablation catheter according to a preferred embodiment of the present application is described. If it is distinguished more finely, Figures 1 to 3 It can be further divided into three different implementation modes under the first implementation mode.

[0050] like Figures 1 to 3 In the illustrated embodiment of the present application, the ablation catheter may include a tubular member 10 , a main control shaft 11 and an ablation assembly A.

[0051] The tubular member 10 has an operating end (for connecting the control handle and controller, not shown) and a working end 101. The working end 101 will enter a predetermined position of the human body for subsequent operation and processing. The tubular member 10 is in the shape of a thin tube and is flexible to allow it to meander through the human body according to different paths; the inner diameter range of the tubular member 10 is usually about 1-5 mm, preferably 1.32-3.96 mm; it can be made of the following materials: polyethylene (PE), polyether block polyamide (PEBAX), nylon (Nylon), thermoplastic polyurethane elastomer (TPU), polyvinyl chloride (PVC), etc. The size and material of the tubular member can be selected and designed differently according to different application conditions, not limited to the examples illustrated above.

[0052] A main control shaft 11 is slidably provided in the tubular member 10. The slidable design of the main control shaft 11 in the tubular member 10 allows a control handle to control the ablation component A to extend from the tubular member 10 to the working end 101 through the main control shaft 11 to perform ablation operations, and allows the ablation component A to be controlled to retract into the tubular member 10 after the operation is completed, and then leave the human body together with the tubular member 10.

[0053] Generally, the main control shaft 11 is also flexible like the tubular member 10, and can be made of materials such as polyethylene (PE), polyether block polyamide (PEBAX), nylon (Nylon), thermoplastic polyurethane elastomer (TPU), polyvinyl chloride (PVC), etc. The radial dimension of the main control shaft is smaller than the inner diameter of the tubular member 10, so as to be accommodated in the tubular member 10 and be able to move in the tubular member 10.

[0054] The ablation assembly A is flexible and slidably disposed in the tubular member 10. Driven by the main control shaft 11, the ablation assembly can be retracted in the tubular member 10 to maintain a linear extension state and can extend from the working end 101 of the tubular member 10 so that the ablation element bearing portion 12 presents at least one radial expansion portion 121, 122, as shown in the various figures, which are schematic diagrams of the ablation element bearing portion 12 in a radial expansion state.

[0055] The ablation component A has an ablation element bearing portion 12 made of shape memory materials, such materials including but not limited to nickel-titanium memory alloys or shape memory polymers. Therefore, when the ablation component extends from the working end 101 of the tubular member 10 under the control of the main control shaft 11 by the control handle, the ablation element bearing portion 12 will automatically show the memorized shape (such as the above-mentioned expanded state). This memorized shape can have different spatial shape options according to different working conditions. Therefore, the expansion form shown in the drawings of the present application specification is only an exemplary diagrammatic representation, and various other forms of expansion forms fall within the protection scope of this application.

[0056] The ablation element bearing portion 12 carries a plurality of ablation elements S arranged at intervals from each other. The ablation element S is electrically connected or communicatively connected to an external controller, so as to release energy to a target site under the control signal of the controller. The ablation element can be used to detect electrical signals of the tissue to be treated when working; and / or to provide at least one of sound energy, electrical and / or magnetic energy, thermal energy, chemical energy, and radiation energy during treatment. However, preferably, the ablation element is an electrode for releasing electrical energy.

[0057] As described above, in a conventional ablation device, if the ablation element carrier is released from the tubular member and unfolded into an expanded state, it is generally impossible to fine-tune the position and shape of the ablation element carrier, especially to fine-tune the position of the ablation element carried on the ablation element carrier, the relative position between the ablation elements, and the relative position between the ablation element and the target target. However, in the actual operation of ablation, it is almost impossible to achieve that the ablation element carrier extends from the tubular member and unfolds, and then touches the very ideal target position with high precision, and there is always a slight position deviation from the target target position. Therefore, the ablation catheter solution of the conventional ablation device cannot cope with these problems. On the one hand, it puts forward very high operating requirements for the operator, and on the other hand, if the tubular member and its ablation element carrier are re-operated, the intraoperative risk is inevitably increased. Moreover, if the deviation is too large and ablation treatment is performed, not only will a good treatment effect not be obtained, but it will even cause additional damage to the patient.

[0058] In order to solve the above problems, in the technical solution of the present application, the ablation catheter includes at least one auxiliary control shaft 13. The auxiliary control shaft 13 is slidably disposed in the tubular member 10, and the auxiliary control shaft 13 is fixedly connected to the ablation element bearing portion 12 of the ablation assembly, so as to slide along the main control shaft 11 driven by the auxiliary control shaft 13. Therefore, by using the auxiliary control shaft 13, the expansion amplitude of the radial expansion part and the relative position of the ablation element S can be flexibly adjusted after the ablation assembly extends from the working end 101 of the tubular member 10.

[0059] According to the above-mentioned ablation catheter, after the ablation component is extended from the working end 101 of the tubular member 10 driven by the main control shaft 11, the posture change of the ablation element bearing part 12 can be controlled by the auxiliary control shaft 13. Specifically, in the state where the ablation component is extended from the working end 101 of the tubular member 10, the auxiliary control shaft 13 can adjust the radial expansion degree of at least one radial expansion part 121, 122 by sliding the ablation element bearing part 12 relative to the main control shaft 11. For example, when the auxiliary control shaft 13 moves toward the radial expansion part 121, the shape of the radial expansion part 121 tends to be annular due to the shape memory of its material, while the radial expansion part 122 is stretched; when the auxiliary control shaft 13 moves toward the radial expansion part 122, the shape of the radial expansion part 122 tends to be annular due to the shape memory of its material, while the radial expansion part 122 is stretched. According to this embodiment, the working posture of the ablation element bearing part 12 is flexibly controlled by the auxiliary control shaft 13.

[0060] The ablation element carrier 12 made of shape memory material can have a variety of memory shapes in its natural state. The radial expansion portion can be in a spiral shape, annular shape or other suitable shape in its natural state; and / or when viewed from the axial direction of the main control shaft 11, the radial expansion portion is a circle, arc shape or ellipse with the main control shaft as the center. On the other hand, the main control shaft 11 can be located near the center or edge of the radial expansion portion. For example Figure 1 In the embodiment shown, the radial expansion parts 121, 122 surround the main control shaft 11, or as shown in FIG. Figure 2 In the illustrated embodiment, the main control shaft 11 is disposed close to the extension track of the radial expansion portions 121 , 122 , and ablation catheters of different structures may be used according to different application scenarios.

[0061] The auxiliary control shaft 13 can realize movement control of the ablation element bearing portion 12 in a variety of ways, which are described below respectively.

[0062] like Figure 1 , Figure 2 As shown, the end E1 of the main control shaft 11 of the ablation catheter is fixedly connected to the end E2 of the ablation element bearing part 12, so as to keep the positions of the end E1 of the main control shaft 11 and the end E2 of the ablation element bearing part 12 relatively fixed when the auxiliary control shaft 13 moves, and can prevent the ablation element bearing part 12 from rotating relative to the main control shaft 11. The auxiliary control shaft 13 can be directly connected to the ablation element bearing part 12 between the radial expansion parts 121 and 122, or preferably, a sliding member 123 is fixedly provided on the ablation element bearing part 12, and the sliding member 123 can be slidably provided on the main control shaft 11 and fixedly connected to the auxiliary control shaft 13, so as to guide the sliding member 123 and the auxiliary control shaft 13. In an embodiment in which a sliding member 123 is provided, the auxiliary control shaft 13 is fixedly connected to the sliding member 123, and the sliding member is fixedly connected to the ablation element carrier 12 and is slidably provided on the main control shaft 11. Therefore, after the ablation element carrier 12 is unfolded under the push of the main control shaft 11, the main control shaft 11 is temporarily stationary. At this time, the pushing and pulling action of the auxiliary control shaft 13 can drive the sliding member 123 to slide along the main control shaft 11, thereby driving the change in the unfolded shape of the ablation element carrier 12.

[0063] When the ablation assembly is extended from the working end 101 of the tubular member 10, the ablation element bearing portion 12 is divided into a first expansion portion 121 and a second expansion portion 122 by the sliding member 123, but the present application is not limited thereto. Figure 1 and Figure 2As shown, when the auxiliary control shaft 13 pushes the sliding member 123 outward, the radial expansion degree of the first expansion portion 121 increases, while the expansion degree of the second expansion portion 122 decreases; and when the auxiliary control shaft 13 pulls the sliding member 123 inward, the radial expansion degree of the first expansion portion 121 decreases, while the expansion degree of the second expansion portion 122 increases. Of course, the main control shaft 11 can also move in coordination with the auxiliary control shaft.

[0064] like Figure 3 As shown, according to another embodiment of the ablation catheter, the end E2 of the ablation element bearing part 12 can also be slidably disposed in the end E1 region of the main control shaft 11. On this basis, the auxiliary control shaft 13 is fixedly connected to the end E2 of the ablation element bearing part 12, and the ablation element bearing part 12 is preferably fixedly connected to the main control shaft 11 through a fixing member 124 (the fixing member 124 can also be omitted). In the state where the ablation assembly extends from the working end 101 of the tubular member 10, the ablation element bearing part 12 is divided into a first expansion portion 121 and a second expansion portion 122 by the fixing member 124. When the main control shaft 11 is fixed, the auxiliary control shaft 13 can be moved to control the movement of the end E2 relative to the main control shaft 11, thereby adjusting the expansion degree of the first expansion part 121; and when the main control shaft 11 and the auxiliary control shaft 13 are moved at the same time, the expansion degree of the second expansion part 122 can be adjusted, thereby also realizing the separate control of the expansion degrees of the first expansion part 121 and the second expansion part 122, and then realizing the flexible adjustment of the relative position between the ablation element S on the first expansion part 121 and the ablation element S on the second expansion part 122.

[0065] The sliding fit between the sliding member 123 or the end E2 and the main control shaft 11 in the above two embodiments can be achieved by a sliding structure such as a slide groove or an axis hole. Preferably, the above sliding fit has a predetermined sliding range, which can be achieved by a stop structure (such as a convex point or a step or a circumferential flange, etc.) provided on the main control shaft 11 and located on the sliding path of the sliding member 123 or the end E2. By limiting the slidable range of the sliding fit, more precise adjustment can be achieved on the basis of allowing position adjustment, thereby improving the accuracy of adjustment.

[0066] Preferably, if Figures 1 to 3 As shown, in the state where the ablation assembly is extended from the working end 101 of the tubular member 10, the expansion degree of the first expansion portion 121, which is farther from the working end 101 of the tubular member 10 in the axial direction, in the radial direction is less than the expansion degree of the second expansion portion 122 in the radial direction. Therefore, in the ablation operation, the first expansion portion 121 is more suitable for the part deep inside the blood vessel, while the second expansion portion 122 is more suitable for the part at the interface between the blood vessel and the heart and its adjacent parts.

[0067] 2. Implementation Method 2

[0068] like Figure 4 , Figure 5 , Figure 6 and Figure 7 As shown, the ablation catheter of the ablation device can also adopt a different Figures 1 to 3 The scheme shown is used to achieve the invention purpose of this application. In fact, Figure 4 Figure 7 can also be divided into different implementation modes. They will be described exemplarily in the following description, but it should be pointed out that the features of the various implementation modes of the present application can be combined with each other under the premise of achieving ablation operation, and these variations are within the protection scope of the present application. In addition, since the present application has been fully described in detail when describing the first implementation mode, the relevant common or repeated parts will be simplified or omitted when describing and explaining the second implementation mode below, and different personalized features will be explained in detail.

[0069] like Figures 4 to 7 As shown, the ablation catheter may include a tubular member 10, a plurality of control shafts 20, and a plurality of ablation components (the "plurality" mentioned here means two or more).

[0070] Similarly, the tubular member 10 is flexible and has an operating end and a working end 101. Multiple control shafts 20 are independently and slidably arranged in parallel in the tubular member 10; each of the multiple ablation assemblies is flexible and has an ablation element bearing portion 12 made of a shape memory material, and the ablation element bearing portion 12 carries a plurality of ablation elements S arranged at intervals from each other.

[0071] The main feature of this embodiment is that each ablation assembly is connected to a respective control shaft 20 and driven by the respective control shaft 20, can be retracted in the tubular member 10 to maintain a linear extension state and can extend from the working end 101 of the tubular member 10 so that the ablation element bearing portion 12 presents a radial expansion portion 121. The radial expansion portion 121 can be in a spiral shape or annular shape or other shapes; and / or when viewed from the axial direction of the control shaft 20, the radial expansion portion is circular, arc-shaped or elliptical, etc.

[0072] According to the ablation catheter of this embodiment, preferably, when the ablation component is extended from the working end 101 of the tubular member 10, different ablation components extend to different degrees in the axial direction. The operator can control the control axis 20 of each ablation component respectively, thereby causing the relative positions of the radial expansion parts 121 to change, thereby achieving a flexible regulation effect.

[0073] When the ablation assembly is extended from the working end 101 of the tubular member 10, the radial expansion portions 121 of different ablation assemblies may have the same expansion degree in the radial direction (eg, Figure 5 , 6 and 7), the plurality of ablation element bearing portions 12 may extend parallel to each other; or the radial expansion portions 121 of different ablation components may have different expansion degrees in the radial direction (eg Figure 4 Preferably, when the ablation assembly is extended from the working end 101 of the tubular member 10, the radial expansion portion 121 of the ablation assembly that extends farther in the axial direction expands less in the radial direction, so that during the ablation operation, the radial expansion portion 121 that extends farther is more suitable for locations deep inside the blood vessel, while the second expansion portion 122 is more suitable for locations at the interface between the blood vessel and the heart and adjacent locations.

[0074] like Figure 4 , Figure 6 and Figure 7 As shown, the ablation catheter preferably includes a sliding guide 21, which is arranged on multiple control shafts 20 and is used to guide the multiple control shafts 20 to slide in sliding directions parallel to each other, so as to prevent a large angle deviation between the multiple control shafts 20 at a position close to the working end 101, thereby reducing the difficulty of operation of the ablation catheter and improving controllability. Wherein, each control shaft 20 is slidably arranged on the sliding guide 21; or at least one control shaft 20 among the multiple control shafts 20 is fixed to the sliding guide 21 and at least one control shaft 20 is slidably arranged on the sliding guide 21. The sliding fit of the sliding guide 21 can be achieved by a sliding structure such as a sliding groove or an axial hole. Preferably, the sliding fit has a predetermined sliding range, and the predetermined sliding range can be achieved by a stop structure (such as a convex point or a step or a circumferential flange, etc.) arranged on the control shaft 20 and located on the sliding path of the sliding guide 21. By limiting the slidable range of the sliding guide 21, more precise adjustment can be achieved on the basis of allowing position adjustment, thereby improving the accuracy of adjustment.

[0075] According to the ablation catheter of this embodiment, the ablation components can be connected as follows: Figure 4 are independent of each other, or can also be Figure 5 , Figure 6 and Figure 7 In the preferred embodiment shown, a matching relationship is added between the ablation components. By adding the matching relationship between the ablation components, not only the position of each ablation component can be more accurately controlled, but also the relative position between each ablation component can be more accurately controlled, and more precise adjustment can be made during adjustment.

[0076] like Figure 5 and Figure 7 As shown, the ends E2 of the ablation element bearing parts 12 can be fixedly connected to each other, so that when the control shaft 20 connected to the ablation assembly moves relatively, the ends E2 of the ablation element bearing parts 12 remain relatively fixed, and the ablation element bearing parts 12 are stretched or compressed along the axial direction of the tubular member 10 (hereinafter referred to as the axial direction). Figure 7 As shown, the ablation catheter preferably includes a telescopic control shaft 30, which is slidably disposed in the tubular member 10. The telescopic control shaft 30 is fixedly connected to the end E2 of each ablation element bearing portion 12, so that when the control shaft 20 is fixed, the telescopic control shaft 30 can simultaneously control the stretching or compression of multiple ablation element bearing portions 12 in the axial direction.

[0077] like Figure 6 As shown, according to another embodiment, the ends E2 of each ablation element bearing part 12 can also be slidably connected to each other within a predetermined sliding range. In the case where the ablation catheter includes a telescopic control shaft 30, the telescopic control shaft 30 is slidably disposed in the tubular member 10 and fixedly connected to the end E2 of the ablation element bearing part 12 that extends outward the farthest from the tubular member 10 (the distance from the working end of the tubular member 10 in the axial direction), so that the end E2 of the ablation element bearing part 12 can be individually controlled to slide relative to the ends E2 of other ablation element bearing parts 12 within a predetermined sliding range.

[0078] Specific as Figure 6 As shown, the ablation assembly preferably includes a first ablation assembly having a first ablation element bearing portion 31 and a second ablation element bearing portion 32. When the ablation assembly is extended from the working end 101 of the tubular member 10, the first ablation element bearing portion 31 extends outward from the tubular member 10 to a greater extent than the second ablation element bearing portion 32. The end E3 of the first ablation element bearing portion 31 and the end E4 of the second ablation element bearing portion 32 are slidably matched within a predetermined sliding range, and the telescopic control shaft 30 is fixedly connected to the end E3 of the first ablation element bearing portion 31. According to this embodiment, the end E3 of the first ablation element bearing portion 31 can be independently controlled to slide relative to the end E4 of the second ablation element bearing portion 32 within the predetermined sliding range through the telescopic control shaft 30; if the control shaft 20 connected to the first ablation element bearing portion 31 and the telescopic control shaft 30 act synchronously, the ablation element S of the first ablation element bearing portion 31 and the ablation element S of the second ablation element bearing portion 32 can also be achieved in the axial direction.

[0079] According to the ablation catheter of any embodiment of the present application, the ablation element S is preferably an electrode, which is used to form an electric field between the ablation elements S to achieve the therapeutic purpose of electric field ablation. Preferably, according to the first embodiment, when the ablation component is extended from the working end 101 of the tubular member 10, the multiple electrodes distributed on at least one radial expansion portion 121, 122 are used to form a circumferential electric field and / or an axial electric field; according to the second embodiment, the multiple electrodes distributed on the radial expansion portion 121 of each ablation component are used to form a circumferential electric field and / or an axial electric field.

[0080] like Figure 1 , Figure 2 and Figure 3 As shown, the circumferential electric field refers to the electric field formed between the ablation elements S distributed on the same radial expansion portion, and its electric field parameters can be changed by changing the stretching degree of the radial expansion portion; the axial electric field refers to the electric field formed between the ablation elements S distributed along the axial direction of the tubular member 10, and the axial distance between the ablation elements S can be changed by adjusting the postures of the radial expansion portions 121, 122, thereby changing the electric field parameters.

[0081] In the technical solution of the present application, the use of multiple electrodes distributed on the ablation assembly to form a circumferential electric field and / or an axial electric field is a technical advantage of the present application. Specifically, in traditional ablation devices, most of them only provide a circumferential electric field, and basically do not provide an axial electric field, or even if they do, their axial electric field is very weak, or the intensity and spatial distribution cannot be adjusted and optimized.

[0082] In the technical solution of the present application, since the ablation elements S can be arranged in a multi-level space in the circumferential direction and the axial direction, and the ablation components have adjustable degrees of freedom, the adjustability and flexibility of the spatial relative positions of different ablation elements S can be achieved. Therefore, according to the ablation catheter of the present application, the circumferential electric field and / or the axial electric field can be flexibly adjusted to adapt to various specific application conditions.

[0083] By flexibly controlling the posture of the ablation element bearing portion 12 through the ablation device of any of the above-mentioned embodiments, it is possible to flexibly adjust the range of action of the ablation element S and the intensity of the electric field. According to different application working conditions, the ablation element S can also be set to different functions. For example, the ablation element S can be set to detect the electrical signal of the tissue to be treated during operation for testing or diagnosis. Furthermore, the ablation element S can also be used to provide at least one of sound (or vibration) energy, electrical and / or magnetic energy, thermal energy, chemical energy, and radiation energy, so as to select an ablation catheter with ablation elements of different functions according to different working conditions, thereby improving the applicability of the ablation device, so that the ablation device of the present application can be not limited to the application of catheter radiofrequency ablation.

[0084] The preferred embodiments of the present application are described in detail above; however, the present application is not limited to the specific details in the above embodiments. Within the technical concept of the present application, a variety of simple modifications can be made to the technical solution of the present application, and these simple modifications all fall within the protection scope of the present application.

[0085] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, this application will not further describe various possible combinations.

[0086] In addition, the various implementation modes of the present application may be arbitrarily combined, and as long as they do not violate the concept of the present application, they should also be regarded as the contents disclosed in the present application.

Claims

1. An ablation catheter, comprising: A tubular member (10) which is flexible and has an operating end and a working end (101); A main control shaft (11), the main control shaft (11) being slidably disposed in the tubular member (10); An ablation component (A) is flexible and slidably arranged in the tubular member (10), the ablation component (A) has an ablation element bearing portion (12) made of a shape memory material, the ablation element bearing portion (12) carries a plurality of ablation elements (S) arranged at intervals from each other, the ablation component (A) can be retracted in the tubular member (10) driven by the main control shaft (11) to maintain a linear extension state and can extend from the working end (101) of the tubular member (10) so that the ablation element bearing portion (12) presents at least one radial expansion portion (121, 122), The ablation catheter comprises: at least one auxiliary control shaft (13), the auxiliary control shaft (13) being slidably disposed in the tubular member (10), the auxiliary control shaft (13) being fixedly connected to the ablation element bearing portion (12) of the ablation assembly so as to slide along the main control shaft (11) under the drive of the auxiliary control shaft (13), The end (E1) of the main control shaft (11) is fixedly connected to the end (E2) of the ablation element bearing portion (12); a sliding member (123) is fixedly arranged on the ablation element bearing portion (12); the sliding member (123) is slidably arranged on the main control shaft (11) and is fixedly connected to the auxiliary control shaft (13); The ablation element bearing portion (12) is divided into a first expansion portion (121) and a second expansion portion (122) by the sliding member (123); When the auxiliary control shaft (13) pushes the sliding member (123) outward to move, the radial expansion degree of the first expansion portion (121) increases, and the expansion degree of the second expansion portion (122) decreases; when the auxiliary control shaft (13) pulls the sliding member (123) inward to move, the radial expansion degree of the first expansion portion (121) decreases, and the expansion degree of the second expansion portion (122) increases; The first expansion portion (121) and the second expansion portion (122) are both in a spiral shape.

2. The ablation catheter according to claim 1, characterized in that: When viewed from the axial direction of the main control shaft (11), the first expansion portion (121) and the second expansion portion (122) are both circular with the main control shaft as the center.

3. The ablation catheter according to claim 1, characterized in that: The sliding fit between the sliding member (123) and the main control shaft (11) is achieved through a sliding structure.

4. The ablation catheter according to claim 3, characterized in that: The sliding structure is a sliding groove or an axial hole.

5. The ablation catheter according to claim 1, characterized in that: The sliding fit between the sliding member (123) and the main control shaft (11) has a predetermined sliding range.

6. The ablation catheter according to claim 1, characterized in that: When the ablation component is extended from the working end (101) of the tubular member (10), the first expansion portion (121) which is farther from the working end (101) of the tubular member (10) in the axial direction has a smaller expansion degree in the radial direction than the second expansion portion (122).

7. The ablation catheter according to claim 1, characterized in that: The ablation element is used to detect electrical signals of the tissue to be treated when in operation.

8. The ablation catheter according to claim 1, characterized in that: The ablation element is used to provide electrical energy when in operation.

9. The ablation catheter according to claim 1, characterized in that: The ablation element is used to provide thermal energy when in operation.

10. The ablation catheter according to claim 1, characterized in that: The ablation element is an electrode.

11. The ablation catheter according to claim 10, characterized in that: When the ablation assembly is extended from the working end (101) of the tubular member (10), the plurality of ablation elements distributed on at least one radial expansion portion (121, 122) are used to form a circumferential electric field and / or an axial electric field.

12. An ablation device, comprising an ablation catheter, a control handle connected to the ablation catheter, and a controller electrically connected to the ablation catheter, characterized in that: The ablation catheter is the ablation catheter described in any one of claims 1-11.

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