Electrophysiology catheter

Abstract

The application relates to an electrophysiological catheter. The electrophysiological catheter comprises a sleeved inner tube and outer tube, the inner tube and the outer tube can move relatively, an electrode assembly connects the inner tube and the outer tube, the electrode assembly comprises: a plurality of groups of matrix groups, the plurality of groups of matrix groups are arranged along the circumference of the inner tube, and the matrix groups connect the inner tube and the outer tube, the matrix groups comprise two or more than two matrixes arranged sequentially along the circumference of the inner tube, the matrixes can be deformed, the matrixes at least comprise connected first segments and second segments, the first segments and the second segments have a first connecting point therebetween, the first connecting points in the same matrix group are connected in contact to form a joint; and an electrode, the electrode is arranged at least at the joint. The electrophysiological catheter provided by the application can improve the stability of the electrode at an ablation position, improve ablation efficiency, and obtain better ablation effect.

Description

[0001] This application is a divisional application of the patent application with the application number 202210629751.4, the application date of June 6, 2022, and the invention name of Electrophysiological catheter. TECHNICAL FIELD

[0002] The present application relates to the technical field of medical devices, in particular to an electrophysiological catheter. BACKGROUND

[0003] With the increasing number of patients in the heart rate market, the continuous development of medical technology, the progress of minimally invasive interventional instruments and other factors, the field of electrophysiology has gradually received more attention. The instruments related to cardiac electrophysiological intervention technology mainly include mapping catheters, ablation catheters and other electrophysiological intervention devices. Among them, the mapping catheter and most of the ablation catheters (radiofrequency ablation and pulse field ablation) are collectively referred to as electrophysiological catheters, and metal electrodes are needed on the catheters as signal or energy transmission media, and the shape and density of the electrodes have a great influence on the efficiency and effect of the mapping catheter and the ablation catheter (radiofrequency ablation and pulse field ablation). At present, when using pulse ablation technology to treat paroxysmal atrial fibrillation, the electrophysiological catheter used is prone to electrode deviation due to poor internal support strength and stability, which affects the adhesion and uniformity of the electrode, and affects the ablation efficiency and ablation effect. SUMMARY

[0004] To solve or partially solve the problems in the related art, the present application provides an electrophysiological catheter which can improve the stability of the electrode at the ablation position while improving the ablation efficiency and obtaining better ablation effect.

[0005] The present application provides an electrophysiological catheter, which comprises a sleeved inner tube and outer tube, the inner tube and the outer tube can move relative to each other, an electrode assembly connects the inner tube and the outer tube, and the electrode assembly comprises:

[0006] A plurality of groups of substrates are arranged along the circumference of the inner tube, and the groups of substrates connect the inner tube and the outer tube, each group of substrates comprises two or more substrates arranged in sequence along the circumference of the inner tube, the substrates can be deformed, and each substrate comprises at least a first segment and a second segment connected to each other, the first segment and the second segment have a first connection point therebetween, and the first connection points in the same group of substrates are connected in contact to form a joint;

[0007] An electrode is arranged at least at the joint.

[0008] In an embodiment, the electrode assembly comprises at least a first state and a second state, and the relative movement between the inner tube and the outer tube can drive the connected electrode assembly to switch between the first state and the second state,

[0009] In the first state, the base bodies are attached to the outer wall of the inner tube along the circumferential direction of the inner tube, and the extension direction of the base bodies is parallel to the axial direction of the inner tube;

[0010] In the second state, the base bodies are deformed to protrude outward relative to the inner tube, and each adjacent first segment in the same group of base bodies encloses a first closed shape, each adjacent second segment encloses a second closed shape, and adjacent groups of base bodies enclose a third closed shape.

[0011] In an embodiment, in the second state, the plurality of groups of base bodies arranged around the circumferential direction of the inner tube has a maximum diameter, and the joint is located on the side away from the outer tube at the plane of the maximum diameter.

[0012] In an embodiment, the electrode includes at least a first electrode and a second electrode, the first electrode is located at the joint, the second electrode is arranged at the second segment, and the second electrode is located at the maximum diameter, or the second electrode is located between the maximum diameter and the joint.

[0013] In an embodiment, the first electrode and the second electrode are electrode rings of annular structure, and along the circumferential direction of the inner tube, the circumferential area of the first electrode is greater than that of the second electrode.

[0014] In an embodiment, along the axial direction of the inner tube, the circumferentially arranged first electrode has a first diameter, and the circumferentially arranged second electrode has a second diameter, which is greater than the first diameter.

[0015] In an embodiment, the electrode assembly includes a plurality of first bases arranged circumferentially on the inner tube for connecting the plurality of groups of base bodies and the inner tube, and the base bodies in the same group of base bodies are respectively connected to different first bases, and / or,

[0016] The electrode assembly includes a plurality of second bases arranged circumferentially between the inner tube and the outer tube on the side close to the outer tube for connecting the plurality of groups of base bodies and the outer tube, and the base bodies in the same group of base bodies are respectively connected to different second bases.

[0017] In an embodiment, the second base and the second segment connection position have a second connection point, the group of base bodies includes two base bodies, and the second connection points of the same second base connection position in adjacent groups of base bodies are in contact and fit,

[0018] The electrode further comprises a third electrode, which is located at the contact-matched second connection point.

[0019] In one embodiment, the electrode assembly comprises a third state, which is formed by the mutual movement between the inner tube and the outer tube on the basis of the second state,

[0020] In the third state, the third electrode is arranged in the gap between the substrate groups in the circumferential direction, the electrode assembly forms an umbrella structure, and along the axis direction of the inner tube, the third electrode forms a plane which is located at least between the first electrode and the second electrode.

[0021] In one embodiment, the electrode assembly comprises a fourth state, which is formed by the mutual movement between the inner tube and the outer tube on the basis of the second state,

[0022] In the fourth state, the third electrode is arranged in the gap between the substrate groups in the circumferential direction, and at least the first electrode, the second electrode and the third electrode are located in the same plane.

[0023] In one embodiment, the substrate comprises a support rod and an insulation layer, the support rod is a metal piece with deformation ability, and the insulation layer covers the surface of the metal piece.

[0024] The technical scheme provided in the application can have the following beneficial effects: the electrophysiological catheter comprises a sleeved inner tube and outer tube, the inner tube and the outer tube can move relative to each other, and the electrode assembly connects the inner tube and the outer tube, the electrode assembly comprises: a plurality of groups of matrix groups, the plurality of groups of matrix groups are arranged along the circumference of the inner tube, and the matrix groups connect the inner tube and the outer tube, the matrix group comprises two or more matrixes arranged in sequence along the circumference of the inner tube, the matrix can be deformed, the matrix comprises at least a first segment and a second segment connected to each other, the first segment and the second segment have a first connecting point therebetween, and the first connecting points in the same matrix group are connected in contact to form a joint; and the electrode is arranged at least at the joint. For the plurality of matrixes arranged in the matrix group, the structure stability and strength of the joint formed by connecting the plurality of first connecting points are obviously increased compared with the first segment and the second segment, and when the electrode is arranged at the joint, not only can the electrode form a larger surface area as an electrode ablation area at the joint, thereby improving the use performance of the electrode, but also by arranging the joint, when the plurality of groups of matrix groups are arranged along the circumference of the inner tube, the strength of the joint is higher than that of other parts of the matrix, and when the electrode is arranged at the joint, the electrode can be stably attached in the axial direction and the radial direction when the electrode assembly is anchored to the ostium of the pulmonary vein, the support stability of the electrode is stronger, and the electrode is less likely to shake in the radial direction, thereby ensuring that the electrodes can maintain uniform arrangement along the circumference, and ablation is facilitated. In addition, for the joint, the joint is formed by the contact and cooperation of the first connecting points of the plurality of matrixes, and in the relative movement process of the inner tube and the outer tube, the matrix is easily limited by the joint position with higher strength, so that the deformation controllability of the plurality of groups of matrix groups is stronger, and the uniformity and the limited cooperation of the electrodes arranged along the circumference with the same diameter are less likely to be affected by external interference.

[0025] It should be understood that the foregoing general description and the following detailed description are only exemplary and explanatory, and are not limiting to the application. BRIEF DESCRIPTION OF DRAWINGS

[0026] The above and other objects, features and advantages of the present application will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings in which like reference characters refer to like parts throughout the several views.

[0027] Figure 1 is a schematic structural view of a head position electrode assembly part of an electrophysiological catheter according to an embodiment of the application;

[0028] Figure 2 is another schematic structural view of a head position electrode assembly part of an electrophysiological catheter according to an embodiment of the application;

[0029] Figure 3is a front view of the head position electrode assembly portion of the electrophysiological catheter of the present application without electrodes;

[0030] Figure 4 is Figure 1 is a top view of the electrophysiological catheter of the present application;

[0031] Figure 5 is a second electrode assembly portion structure schematic diagram of the head position of the electrophysiological catheter of the present application;

[0032] Figure 6 is Figure 5 is a front view of the electrophysiological catheter of the present application;

[0033] Figure 7 is Figure 5 is a top view of the electrophysiological catheter of the present application;

[0034] Figure 8 is a third electrode assembly portion structure schematic diagram of the head position of the electrophysiological catheter of the present application;

[0035] Figure 9 is a fourth electrode assembly portion structure schematic diagram of the head position of the electrophysiological catheter of the present application;

[0036] Figure 10 is Figure 9 is a top view of the electrophysiological catheter of the present application;

[0037] Figure 11 is a fifth electrode assembly portion structure schematic diagram of the head position of the electrophysiological catheter of the present application;

[0038] Figure 12 is Figure 11 is a front view of the electrophysiological catheter of the present application;

[0039] Figure 13 is Figure 11 is a top view of the electrophysiological catheter of the present application. DETAILED DESCRIPTION

[0040] Embodiments of the present application will be described more fully hereinafter with reference to the accompanying drawings. This application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art.

[0041] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting. As used in this application and the appended claims, the singular forms "a," "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "and / or," as used herein, refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0042] It should be understood that, although the terms "first," "second," "third," etc. can be used herein to describe various information, these terms are not intended to denote a particular order or hierarchy. These terms are used only to distinguish one from another among the information. For example, a first information can also be referred to as a second information, and similarly, a second information can also be referred to as a first information, without departing from the scope of the present application. Therefore, the features defined with "first," "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise specifically limited.

[0043] In the surgery using electrophysiological therapy, it is a common means to deliver energy through a catheter and carry out tissue ablation or mapping, and the electrode arranged on the catheter serves as a medium for signal or energy delivery to achieve the purpose. It can be understood that the instruments related to the electrophysiological catheter cardiac electrophysiological intervention technology mainly include a mapping catheter, an ablation catheter and other electrophysiological intervention devices, which are collectively referred to as electrophysiological catheters here, without specific division. For example, in the treatment of paroxysmal atrial fibrillation using pulse ablation technology, the electrophysiological catheter needs to be inserted through the blood vessel, and the head of the catheter needs to be arranged with electrodes to be expanded into a corresponding shape and anchored at the ostium of the pulmonary vein. Therefore, for the electrodes, the shape, arrangement form, density and adhesion to the tissue of the electrodes will have a great influence on the use efficiency and effect of the electrophysiological catheter.

[0044] In view of the above problems, the embodiments of the present application provide an electrophysiological catheter which can improve the stability of the electrodes at the ablation position and improve the ablation efficiency.

[0045] The technical solutions of the embodiments of the present application are described in detail below with reference to the drawings.

[0046] Figure 1 is a schematic structural diagram of a head position electrode assembly part of the electrophysiological catheter shown in the embodiments of the present application.

[0047] Referring to Figure 1As an embodiment of the present application, the electrophysiological catheter comprises a sleeved inner tube 2 and outer tube 1, the inner tube 2 and outer tube 1 can move relatively, the inner tube 2 at least partially extends out of the outer tube 1, and an electrode assembly 3 is arranged on the extended part, the electrode assembly 3 connects the inner tube 2 and outer tube 1, and the relative movement of the inner tube 2 and outer tube 1 can drive the electrode assembly 3 to deform, so that the electrode assembly 3 does not hinder the blood vessel when it extends into the blood vessel, and can abut against the treatment position to perform ablation during treatment.

[0048] The electrophysiological catheter has a head end and a tail end along its extension direction, the electrode assembly 3 is located at the head end, and the tail end is provided with an adjusting part, the adjusting part connects the sleeved inner tube 2 and outer tube 1, and can control the movement of the inner tube 2 along the axial direction L (extension direction) of the catheter relative to the outer tube 1. Optionally, the adjusting part comprises a button and a sliding assembly for slidingly connecting the inner tube 2 and outer tube 1, and pushing the button can drive the sliding assembly to produce a matching movement in the axial direction, thereby driving the inner tube 2 to move axially relative to the outer tube 1, so as to control the electrode assembly 3 located at the head end to produce a corresponding deformation. The adjusting part can also be provided as other matching structures capable of controlling the relative axial movement of the inner tube 2 and outer tube 1, which will not be limited here.

[0049] It can be understood that the axes of the inner tube 2 and outer tube 1 coincide, and in order to facilitate the blood vessel to enter the position where anchoring is required, the inner tube 2 and outer tube 1 are both provided as deformable flexible tubes, and the specific material thereof will not be described in detail here.

[0050] Referring to Figure 2 , Figure 3 and Figure 4 , the electrode assembly 3 comprises a plurality of groups of substrates 31 and electrodes 32, the groups of substrates 31 are arranged along the circumference of the inner tube 2, and the substrate groups 31 connect the inner tube 2 and outer tube 1, the substrate group 31 comprises two or more substrates arranged at intervals along the circumference of the inner tube 2, the substrate can deform, and the substrate at least comprises a first segment 311 and a second segment 312 connected, the first segment 311 and the second segment 312 have a first connection point therebetween, and the first connection points in the same substrate group 31 are connected in contact to form a joint 313; the electrode 32 is arranged at least on the joint 313.

[0051] Specifically, among the sleeved inner tube 2 and outer tube 1, the inner tube 2 at the head end part at least partially extends out of the outer tube 1, and the electrode assembly 3 is located at the extended part. And for the electrode assembly 3, the substrate group 31 is a support structure for arranging the electrode 32, the substrate group 31 is arranged along the circumference of the inner tube 2, so that the electrode 32 arranged on the substrate group 31 can be arranged at least circumferentially on the inner tube 2, so that the electrode 32 can simultaneously ablate in the circumferential direction, without the need to rotate the electrophysiological catheter in the circumferential direction to rotate the electrode in the circumferential direction to achieve ablation, thereby improving the ablation efficiency.

[0052] The base groups 31 are uniformly arranged along the circumference of the inner tube 2, and the connecting portions 313 in the plurality of base groups 31 are uniformly arranged along the circumference, so that the electrodes 32 arranged on the base groups 31 can be uniformly arranged along the circumference. When ablation is performed by the electrodes 32, the electrodes 32 along the circumference can uniformly ablate the corresponding positions, thereby improving the ablation effect. Optionally, the number of the base groups 31 arranged along the circumference can be adaptively adjusted according to the density requirement of the electrode arrangement, for example, the base groups 31 can be arranged as six in Figure 2 , or can be arranged as five in Figure 5 , which is not specifically limited here.

[0053] Optionally, the connecting portions 313 in the plurality of base groups 31 are located in the same plane, and the plane formed by the electrodes 32 arranged at the connecting portions 313 can be perpendicular to the axis direction L of the inner tube 2, or the two can intersect at an angle, which will be adjusted according to different ablation scenarios, which is not specifically limited here.

[0054] The base group 31 includes two or more bases sequentially arranged along the circumference of the inner tube 2, the base can be deformed, and the two ends of the length direction of the base are connected to the outer wall of the inner tube 2 and the inner wall of the outer tube 1 respectively. The base can be a metal piece or a non-metal piece with elastic deformation ability, and the base can be a tubular structure obtained by cutting, which can reduce the weight while ensuring that the base has high support stability, thereby facilitating the convenience of passing through the human body.

[0055] Optionally, the base includes a support rod and an insulating layer, the support rod is a metal piece with specific deformation ability and has a tubular structure, and the insulating layer covers the surface of the metal piece. The metal support rod has high support strength and support stability, the insulating layer is used to block the conductive performance of the support rod, and the electrode arranged on the surface of the insulating layer is insulated from the support rod. When the electrode is used, the support rod is avoided to act as a conductive medium to divide the pulse acting on the electrode 32, so as to reduce the field strength, thereby ensuring the use effect of the electrode 32.

[0056] It can be understood that the insulating layer can be a material with good insulation, elasticity and not easy to wrinkle, for example, PET, PVC or TPU, and the insulating layer can be an insulating coating coated on the surface of the support rod.

[0057] For the two or more substrates arranged in the substrate group 31, specifically including the connected first segment 311 and the second segment 312, the first segment 311 and the second segment 312 have a first connecting point at the connecting position, the first connecting points in the same substrate group 31 are in contact and cooperation to form a joint 313, and the ends of the first segment 311 and the second segment 312 away from the first connecting point are respectively used to connect the inner tube 2 and the outer tube 1. For the plurality of substrates arranged in the substrate group 31, the joint 313 formed after the plurality of first connecting points are connected has a structure stability and strength at the position of the joint 313 that is obviously increased compared with the first segment 311 and the second segment 312. When the electrode 32 is arranged at the joint 313, not only is it beneficial for the electrode 32 at the joint 313 to be able to form a larger surface area as an electrode ablation area to improve the use performance of the electrode 32, but also through the joint 313 arranged, when a plurality of substrate groups 31 are arranged in the circumferential direction of the inner tube 2, the joint 313 has a higher strength at this position compared with other parts of the substrate, and when the electrode 32 is arranged at this position, the joint 313 can ensure that the electrode 32 can be stably attached in the axial direction and the radial direction when the electrode assembly 3 is anchored to the ostium of the pulmonary vein, the support stability of the electrode 32 is stronger, and the electrode 32 is not prone to radial shaking, thereby ensuring that the electrodes 32 can maintain uniform arrangement in the circumferential direction, which is beneficial for ablation. In addition, for the joint 313, since it is formed by the contact and cooperation of the first connecting points of a plurality of substrates, during the relative movement of the inner tube 2 and the outer tube 1, the substrate is easily limited by the joint 313 at the position with higher strength, so that the deformation of the plurality of substrate groups 31 is more controllable, and the uniformity and the same-diameter circumferential arrangement of the electrodes 32 are not easily affected by external interference.

[0058] The electrode assembly 3 in the present application will be described in detail below with two substrates arranged in the substrate group.

[0059] In an embodiment, referring to Figure 5 , Figure 6 and Figure 7 , the electrode assembly 3 at least includes a first state and a second state, and the relative movement between the inner tube 2 and the outer tube 1 can drive the connected electrode assembly 3 to switch between the first state and the second state. In the first state, the substrate is attached to the outer wall of the inner tube in the circumferential direction of the inner tube 2, and the extension direction of the substrate is parallel to the axis direction of the inner tube 2. In the second state, the substrate is deformed to protrude outward relative to the inner tube 2, and each adjacent first segment 311 in the same substrate group 31 encloses a first closed shape 311a, each adjacent second segment 312 encloses a second closed shape 312a, and adjacent substrate groups 31 enclose a third closed shape 31a. Through such an arrangement, the electrode assembly 3 can have good human passability in the first state, and better support stability for the electrode 32 can be provided by the substrate group 31 in the second state.

[0060] Specifically, the first state is a tightening state, in which the bases of the plurality of base groups 31 arranged circumferentially along the inner tube are respectively attached to the outer wall of the inner tube 2, so that the maximum diameter does not exceed the outer diameter of the outer tube 1, so that the electrode assembly 3 can pass through the human body conveniently. In addition, in the tightening state, the first segments 311 and the second segments 312 can be arranged in close contact or with a gap between the same base group 31 or adjacent base groups 31, so as to achieve the tightening effect while arranging more bases. The second state is an expanded state, and after the electrode assembly 3 enters the human body in the first state, when reaching the ostium of the pulmonary vein where anchoring is required, the electrode assembly 3 enters the second state by controlling the movement of the inner tube 2 relative to the outer tube 1 along the axial direction L. In the second state, the bases are deformed to form a hollow spherical structure between the plurality of base groups 31, and the base groups 31 form a spherical framework. In the spherical structure, the first segments 311, the second segments 312, and the adjacent base groups 31 form closed shapes through the arranged connecting portions 313, so as to form a grid sphere that looks like a grid shape, and the connecting portions 313 are a combination of a plurality of first connection points, which can make the structure of each closed shape more stable when they are part of the closed shape. At the same time, arranging the electrodes 32 on the connecting portions 313 is conducive to better attaching the electrodes 32 to the pulmonary vein, and the electrodes 32 are less likely to be displaced in position between the circumferentially arranged electrodes 32 due to the radial rotating force, so that the electrode ablation area is uniform, stable, and continuous.

[0061] More specifically, for the arranged connecting portions 313, the cross-sectional area along the catheter axis direction L is greater than the maximum cross-sectional area of any base. When the plurality of first connection points are in contact and connected to form the connecting portion 313, the strength of the base is effectively increased, and arranging the electrodes 32 on the connecting portion 313 is conducive to the stability of the arrangement of the electrodes 32, which is less likely to deform when anchoring at the ostium of the pulmonary vein, and the electrodes 32 can be arranged uniformly.

[0062] Optionally, when the plurality of first connection points are in contact and connected to form the connecting portion 313, they can be connected into one body by welding or other operations, and in order to facilitate the arrangement of the electrodes 32 on the formed connecting portion 313, the outer surface of the connecting portion 313 is smoothly transitioned when the plurality of first connection points are in contact and connected to form the connecting portion 313, and the cross-section can be an elliptical or polygonal tubular structure, and the electrodes 32 can be arranged circumferentially around the connecting portion.

[0063] For the arranged connecting portion 313, the surface arranged away from the inner tube 2 in the radial direction is an ablation surface, which can be attached to the surface of the pulmonary vein in the second state, and the length corresponding in the circumferential direction is greater than the width of any base in the circumferential direction, so as to improve the ablation efficiency.

[0064] It can be understood that for the set joint 313, the outer side wall of the joint 313 at least includes opposite first and second surfaces, the second surface is the surface of the opposite side of the adjacent base group 31 along the circumference of the catheter, and the first surface is the two surfaces opposite in the radial direction of the catheter, and the first surface away from the inner tube 2 is the ablation surface. In the first state, the first surface on the side of the axis can at least partially fit the outer wall of the inner tube 2, and the second surface between the adjacent base groups 31 can be in contact or have a gap. When the electrode assembly 3 is converted from the first state to the second state, the joint 313 moves radially away from the catheter axis L, so that the first segment 311 and the second segment 312 of the base are deformed, the diameter formed by the circumferentially arranged joints 313 increases, so that the ablation surface can at least partially fit the tissue, the joint 313 can provide the electrode 32 with greater and more stable support force, while increasing the abutting area of the ablation surface when it fits the tissue, and ensuring the fitting effect of the electrode ablation surface and the tissue.

[0065] When the electrophysiological catheter is anchored at the pulmonary vein ostium in the second state, the base is combined to form a spherical structure after being bent and deformed, and after being connected to the inner tube 2 and the outer tube 1, the joint 313 is set to form a first closed shape 311a, a second closed shape 312a, and a third closed shape 31a, etc. in the base group 31 and between the groups, forming a grid-like structure of different sizes in the spherical structure. The first closed shape 311a and the second closed shape 312a formed between the base groups 31 by the setting of the joint 313 can be an elliptical structure, so that the electrode 32 located at the joint 313 has higher stability in the radial direction, to improve the stability of the base support. And the base groups 31 can form a firm quadrilateral structure through the setting of the joint 313, to ensure the stability of the electrode 32 in the axial direction. Finally, the entire electrode assembly 3 can form a firm whole, to ensure the stability of the relative position of the electrode 32 in the second state, and to ensure the uniformity, stability and continuity of the electrode ablation area.

[0066] It can be understood that in order to enable the base to deform to the corresponding shape and maintain the corresponding shape in the required state when the electrode assembly 3 is converted to different states, the base needs to be pre-shaped before being installed to form the electrode assembly 3, so that the base can be conveniently and quickly converted between the first state and the second state, and the stability formed in different states is better. Generally, when the base includes a support rod and an insulating layer, the pre-shaping is mainly performed on the support rod with deformation capability, and then the insulating layer is arranged on the support rod. For the pre-shaping, a common heat treatment shaping method for the support rod is used, which will not be described in detail here.

[0067] In an embodiment, referring to Figure 6 andFigure 7 In the second state, the plurality of groups of substrates 31 arranged circumferentially around the inner tube 2 has the largest diameter, and the joint 313 is located on the side of the plane S where the largest diameter is located, away from the outer tube. By such an arrangement, the joint 313 is arranged circumferentially in the upper half of the spherical structure in the axial direction, so that the electrode 32 can have a better abutting effect, and the circumferentially arranged electrodes 32 can achieve uniform ablation. Optionally, the second closed shape 312a is larger than the first closed shape 311a, so as to improve the structural stability of the position of the joint 313.

[0068] As a specific embodiment of the present application, continuing to refer to Figure 6 and Figure 7 , the electrode 32 at least includes a first electrode 321 and a second electrode 322, the first electrode 321 is located at the joint 313, and the second electrode 322 is arranged at the second section 312, and the second electrode 322 is located at the position of the largest diameter, or the second electrode 322 is located between the position of the largest diameter and the joint 313. In this structure, by arranging the first electrode 321 and the second electrode 322, the first electrode 321 and the second electrode 322 are respectively arranged circumferentially uniformly, while the arrangement of the first electrode 321 and the second electrode 322 along the axial direction L of the catheter can increase the ablation area and the ablation depth in the axial direction, increase the number of electrodes 32, so that the electrophysiological catheter increases the single ablation area in the axial and radial directions. The second electrode 322 arranged in the electrode assembly 3 in a ring shape is uniformly arranged, which can be used for mapping and used to realize the mapping function.

[0069] Optionally, the first electrode 321 and the second electrode 322 are ring-shaped electrodes, and the area of the first electrode 321 in the circumferential direction is larger than the area of the second electrode 322 in the circumferential direction. By arranging the electrode 32 in the form of an electrode ring for installation and fixation on the substrate, the ring shape of the electrode ring can be adjusted according to the shape of the cross section of the substrate. After the electrodes are arranged in a ring structure at the corresponding positions, a plurality of first electrodes 321 are arranged circumferentially along the inner tube 2, and a plurality of second electrodes 322 are arranged circumferentially along the inner tube 2. And for the torus surrounded by the circumferentially arranged first electrodes 321, since the first electrode 321 is located at the joint 313, the area of each first electrode 321 that can be exposed to the outside is larger than the area of the second electrode 322 that can be exposed to the outside. The area exposed to the outside can be used as an ablation area. Therefore, for the first electrode 321 arranged at the joint 313, it can arrange a larger effective area in the first electrode 321 for use as an ablation area, to make up for the large gap between the adjacent first electrodes 321 in the circumferential direction.

[0070] It can be understood that, along the axial direction L of the inner tube 2, the circumferentially arranged first electrodes 321 have a first diameter, and the circumferentially arranged second electrodes 322 have a second diameter larger than the first diameter. That is, the plurality of first electrodes 321 are circumferentially arranged along the inner tube 2 at the first diameter, and the plurality of second electrodes 322 are circumferentially arranged along the inner tube 2 at the second diameter, and the first electrodes 321 are located at the connecting portions 313 and the second electrodes 322 are located at the second sections 312, so that the first electrodes 321 having a larger ablation area are preferentially in contact with the tissue and have a better fitting effect, which is beneficial to improving the ablation efficiency and ablation effect, and the second diameter larger than the first diameter can be used as a mapping electrode.

[0071] In an embodiment, referring to Figure 8 , the electrode assembly 3 includes a plurality of first bases 33 circumferentially arranged on the inner tube 2 for connecting the plurality of groups of substrates 31 and the inner tube 2, the substrates in the same group of substrates 31 are respectively connected to different first bases 33, and / or the electrode assembly 3 includes a plurality of second bases 34 circumferentially arranged between the inner tube 2 and the outer tube 2 on the side close to the outer tube 1 for connecting the plurality of groups of substrates 31 and the outer tube 1, the substrates in the same group of substrates 31 are respectively connected to different second bases 34. The first base 33 is detachably connected to the head end of the inner tube 2, the head end of the inner tube 2 is provided with a mounting portion, the first base 33 connects the mounting portion and the group of substrates 31, and the plurality of first bases 33 are circumferentially arranged on the mounting portion. The second base 34 is detachably connected to the inner side wall of the outer tube 1 and at least partially protrudes out of the outer tube 1, and the second base 34 is circumferentially arranged on the inner wall of the outer tube 1 to correspond to the corresponding number of groups of substrates 31. The group of substrates 31 includes first substrates and second substrates, and the first substrates and the second substrates between adjacent groups of substrates are connected to the same base, so that the first sections 311 in the same group of substrates and the second sections 312 form a closed structure, and the adjacent groups of substrates 31 form a closed structure. The design of this connection mode can improve the structural stability of the group of substrates 31 and between the groups of substrates 31, and more electrodes can be arranged, which is beneficial to the uniformity and efficiency of ablation.

[0072] Optionally, the second base 34 and the second segment 312 connecting position have a second connecting point 314, the base group 31 comprises two bases, the second connecting points 314 of the same connecting position of the second base 34 in the adjacent base group 31 are in contact and cooperation, and the electrode 32 further comprises a third electrode 323, the third electrode 323 is located at the second connecting point 314 in contact and cooperation. By arranging the third electrode 323 at the position of the second connecting point 314, the ablation area of the third electrode 323 can be increased, and the third electrode 323 arranged at the position of the second connecting point 314 has better structural stability. The third electrode 323 can be used as a mapping electrode or an ablation electrode, which is not limited here. Moreover, the arrangement of the third electrode 323 can increase the ablation area in the catheter axial direction L.

[0073] In an embodiment, referring to Figure 9 and Figure 10 , the electrode assembly 3 comprises a third state, which is formed by the mutual approach movement between the inner tube 2 and the outer tube 1 on the basis of the second state, in the third state, the third electrode 323 is circumferentially arranged in the gap between the base groups 31, the electrode assembly 3 forms an umbrella structure, and along the axis direction L of the inner tube 2, the plane formed by the third electrode 323 is located at least between the first electrode 321 and the second electrode 322. By arranging the third electrode 323 at the second connecting point 314 in the third state, the electrode assembly 3 forms an umbrella structure, and the third electrode 323 located at the second connecting point 314 enters the gap between the base groups 31 in this state, so that the third electrode 323 can be used as an ablation electrode, and the circumferentially arranged ablation electrodes increase in density in cooperation with the first electrode, thereby increasing the ablation efficiency.

[0074] Optionally, in the third state, the first electrode 321, the second electrode 322 and the third electrode 323 form a ring structure with different diameters in the axis direction L of the inner tube 2, the diameter of the ring-shaped third electrode 323 is the smallest, the diameter of the second electrode 322 is the largest, and each first electrode 321, second electrode 322 and third electrode 323 are arranged alternately, so that the electrodes 32 are arranged more uniformly, thereby improving the ablation efficiency.

[0075] In an optional embodiment, referring to Figures 11 to 13In the fourth state, the third electrode 323 is arranged in the gap between the base groups 31 in the circumferential direction of the inner tube 2, and the first electrode 321, the second electrode 322 and the third electrode 323 are located in the same plane. In this state, the arrangement of different electrodes in the same plane can make them all used for the ablation of the tissue, the ablation area is increased, and the ablation efficiency and ablation effect are improved. In this state, the third electrode 323 between the base groups 31 can be arranged in the circumferential direction of the inner tube 2 with the same diameter as the first electrode 321, and the first electrode 321 and the third electrode 323 are arranged in the circumferential direction of the inner tube 2. Optionally, the plane formed by the first electrode 321, the second electrode 322 and the third electrode 323 can be perpendicular to the axis direction L of the inner tube 2, or can be intersected at an angle with the axis of the inner tube 2. The diameter of the second electrode 322 arranged in the circumferential direction of the inner tube 2 is greater than that of the first electrode 321, which is not limited here.

[0076] It can be understood that, in order to increase the ablation efficiency, the fourth electrode, the fifth electrode and the like can also be arranged on the base in the circumferential direction, which is not described in detail here.

[0077] In an embodiment, the electrophysiological catheter further comprises a wire, and the tail end of the electrophysiological catheter is provided with a power supply (high-voltage generating device). The wire is connected with the electrodes and extends to the tail end to be electrically connected with the power supply, so as to form a positive electrode and a negative electrode between the electrodes 32 to form a field, thereby realizing the ablation of the lesion position.

[0078] Optionally, the wire can be arranged between the support rod and the insulating layer, or can also be arranged in the cavity of the tubular structure of the support rod. The wire has good conductivity and can withstand a voltage of 1000V or more without being broken down.

[0079] The above has described the embodiments of the present application. The above description is exemplary and is not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes are obvious to those skilled in the art without departing from the scope and spirit of the described embodiments. The selection of the terms used herein is intended to best explain the principles, practical applications or improvements of the technology in the market, or to enable other ordinary skilled persons in the art to understand the embodiments disclosed herein.

Claims

1. An electrophysiological catheter, characterized in that, The assembly includes an inner tube and an outer tube that are sleeved together, the inner tube and the outer tube being movable relative to each other, and an electrode assembly connecting the inner tube and the outer tube. The electrode assembly includes: Multiple base groups are arranged circumferentially along the inner tube and connect the inner tube and the outer tube. Each base group includes two or more bases arranged sequentially along the circumferential direction of the inner tube. Each base is deformable and includes at least a first segment and a second segment connected together. The first segment and the second segment have a first connection point. The first connection point in the same base group is contacted and connected to form a connecting part. An electrode is provided at least in the connecting portion; the electrode includes a first electrode, a second electrode, and a third electrode; the plane formed by the first electrode, the second electrode, and the third electrode is perpendicular to the axial direction of the inner tube; or, the plane formed by the first electrode, the second electrode, and the third electrode intersects the axial direction of the inner tube, and the diameter of the second electrode arranged circumferentially along the inner tube is larger than the diameter of the first electrode. Multiple bases are provided for connecting multiple sets of base groups and the inner or outer tube, wherein the bases in the same base group are respectively connected to different bases; the base group includes a first base and a second base, and the first base and the second base between adjacent base groups are connected to the same base.

2. The electrophysiological catheter according to claim 1, characterized in that: The plurality of bases include: A plurality of first bases are circumferentially arranged in the inner tube for connecting the plurality of base groups and the inner tube. The bases in the same base group are respectively connected to different first bases, and / or... A plurality of second bases are arranged circumferentially between the inner tube and the outer tube near the side of the outer tube, for connecting the plurality of base groups and the outer tube, wherein the bases in the same base group are respectively connected to different second bases.

3. The electrophysiological catheter according to claim 2, characterized in that: The electrophysiological catheter has a head end and a tail end along its extension direction, and the electrode assembly is located at the head end; the tail end is provided with an adjustment part, which connects the inner tube and the outer tube to which it is sleeved.

4. The electrophysiological catheter according to claim 3, characterized in that: The adjustment unit includes a button and a sliding assembly that slidably connects the inner tube and the outer tube. The button is used to drive the sliding assembly.

5. The electrophysiological catheter according to claim 3, characterized in that: The first base is located at the head end; The head end is provided with a mounting part, and a plurality of first bases are arranged circumferentially on the mounting part, the first bases connecting the mounting part to the base assembly.

6. The electrophysiological catheter according to claim 2, characterized in that: The second base is detachably connected to the inner wall of the outer tube and extends at least partially out of the outer tube.

7. The electrophysiological catheter according to claim 2, characterized in that: The second base is circumferentially arranged on the inner sidewall of the outer tube and corresponds to the base assembly.

8. The electrophysiological catheter according to claim 1, characterized in that: It also includes a wire connected to the electrode, and the tail end of the electrophysiological catheter is provided with a power source. The wire extends to the tail end and is electrically connected to the power source.

9. The electrophysiological catheter according to claim 8, characterized in that: The substrate includes a support rod and an insulating layer; The wire is disposed between the insulation layer of the support rod and the substrate; or, the wire is disposed within the cavity of the tubular structure of the support rod.

Images