WO2022267301A1

WO2022267301A1 - Electrode component, electrophysiological catheter, and electrophysiological system

Info

Publication number: WO2022267301A1
Application number: PCT/CN2021/129489
Authority: WO
Inventors: 周磊; 朱美娇; 曹海朋; 史胜凤; 薛卫
Original assignee: 上海安钛克医疗科技有限公司
Priority date: 2021-06-22
Filing date: 2021-11-09
Publication date: 2022-12-29
Also published as: CN113274124A

Abstract

Provided are an electrode component (100), an electrophysiological catheter (200), and an electrophysiological system. The electrode component (100) comprises an electrode main body (110) as well as a sub-electrode component and an electrical transmission line arranged on the electrode main body (110); the electrical transmission line comprises multiple ablation lines, and the sub-electrode component comprises multiple first ablation electrodes (121) and multiple second ablation electrodes (122); the ablation lines each comprise a transmission main circuit (140), a first transmission branch (141) and a second transmission branch (142); the first ablation electrodes (121) and the second ablation electrodes (122) are electrically connected to an output end of the corresponding first transmission branches (141) and an output end of the second transmission branches (142), respectively; and an input end of the first transmission branches (141) and an input end of the second transmission branches (142) converge on the transmission main circuits (140). By arranging in parallel the transmission branches (141, 142) of different ablation electrodes, the resistance value of an ablation line is reduced, the current resistance capability of the ablation line is improved, an ablation boundary of the catheter (200) is also improved, and ablation depth is improved.

Description

电极组件、电生理导管及电生理***Electrode assembly, electrophysiology catheter and electrophysiology system

技术领域technical field

本发明涉及医疗器械技术领域，特别涉及一种电极组件、电生理导管及电生理***。The invention relates to the technical field of medical devices, in particular to an electrode assembly, an electrophysiological catheter and an electrophysiological system.

背景技术Background technique

在电生理治疗领域，利用电生理导管传输能量进行组织消融是常用手段。具体地，电生理导管包括导管及设置于导管的头端上的电极组件。将导管的头端***至需要治疗的目标靶点后，通过能量供应平台向电极组件提供能量，并使电极组件与目标靶位贴靠以将能量传递至目标靶位，进而进行消融。其中，常用的能量是不可逆电穿孔的脉冲电场，该脉冲电场具有细胞选择性，尤其是在肺静脉隔离消融过程中可以有效避免食道和膈神经损伤。为了能够形成有效的消融深度，导管形成的脉冲电场场强分布区域应当最大化。In the field of electrophysiological therapy, the use of electrophysiological catheters to transmit energy for tissue ablation is a common method. Specifically, the electrophysiological catheter includes a catheter and an electrode assembly arranged on the head end of the catheter. After the head end of the catheter is inserted into the target site to be treated, energy is supplied to the electrode assembly through the energy supply platform, and the electrode assembly is attached to the target site to transfer the energy to the target site for ablation. Among them, the commonly used energy is the pulsed electric field of irreversible electroporation, which is cell-selective, especially in the process of pulmonary vein isolation and ablation, which can effectively avoid damage to the esophagus and phrenic nerve. In order to form an effective ablation depth, the field strength distribution area of the pulsed electric field formed by the catheter should be maximized.

柔性电路目前广泛应用于电生理领域，其结构特点使得能将更大的电极密度布置在导管远端，从而可以实现高密度电生理标测导管，例如波士顿科学的Intellamap Orion高分辨率标测导管。然而，当用于脉冲电场消融时，由于脉冲电场消融需要较高的电压，对于导管的能量传输介质的耐电流能力有较高的要求，传输介质需要较大横截面积以降低电阻来提高传输性能。并且，为了实现标测功能，需要每个电极的传输介质之间有耐压要求，以及需要增加绝缘介质，进而使得脉冲电场消融导管的电极设计空间占比会大于普通的标测导管和射频消融导管。或者换言之，上述的两个要求会限制脉冲消融导管的脉冲消融参数(电压、消融时间)，从而降低消融效果。Flexible circuits are currently widely used in the field of electrophysiology, and their structural characteristics enable greater electrode density to be placed at the distal end of the catheter, thereby enabling high-density electrophysiological mapping catheters, such as Boston Scientific's Intellamap Orion high-resolution mapping catheter . However, when used for pulsed electric field ablation, because pulsed electric field ablation requires a higher voltage, there is a higher requirement for the current resistance of the energy transmission medium of the catheter, and the transmission medium needs a larger cross-sectional area to reduce resistance to improve transmission performance. Moreover, in order to realize the mapping function, it is necessary to have a withstand voltage requirement between the transmission media of each electrode, and to increase the insulating medium, so that the electrode design space ratio of the pulsed electric field ablation catheter will be larger than that of ordinary mapping catheters and radiofrequency ablation. catheter. Or in other words, the above two requirements will limit the pulse ablation parameters (voltage, ablation time) of the pulse ablation catheter, thereby reducing the ablation effect.

发明内容Contents of the invention

本发明提供一种电极组件、电生理导管及电生理***，以解决现有技术中存在的问题，尤其用于解决现有技术中的传输介质需要较大横截面积以降低电阻来提高传输性能的问题。The invention provides an electrode assembly, an electrophysiological catheter and an electrophysiological system to solve the problems existing in the prior art, especially to solve the problem that the transmission medium in the prior art requires a large cross-sectional area to reduce resistance and improve transmission performance The problem.

为解决上述技术问题，基于本发明的一个方面，本发明提供一种电极组件，能够设置于一导管的远端，并用于在设备(能量源)和预定部位之间传输能量，所述电极组件包括电极主体及布置于所述电极主体上的子电极组件和电传输线路，所述电传输线路包括若干消融线路，所述子电极组件包括若干第一消融电极及若干第二消融电极，所述消融线路包括传输主路、第一传输支路及第二传输支路，所述第一消融电极和所述第二消融电极分别与对应的所述第一传输支路的输出端和所述第二传输支路的输出端电连接，所述第一传输支路的输入端与所述第二传输支路的输入端交汇于所述传输主路。In order to solve the above technical problems, based on one aspect of the present invention, the present invention provides an electrode assembly that can be arranged at the distal end of a catheter and used to transmit energy between a device (energy source) and a predetermined site, the electrode assembly It includes an electrode body, a sub-electrode assembly arranged on the electrode body, and an electrical transmission line, the electrical transmission line includes a number of ablation lines, the sub-electrode assembly includes a number of first ablation electrodes and a number of second ablation electrodes, the The ablation circuit includes a transmission main circuit, a first transmission branch and a second transmission branch, and the first ablation electrode and the second ablation electrode are respectively connected to the corresponding output end of the first transmission branch and the second transmission branch. The output ends of the two transmission branches are electrically connected, and the input end of the first transmission branch and the input end of the second transmission branch meet at the transmission main road.

可选的，所述子电极组件还包括若干标测电极，所述电传输线路还包括布置于所述电极主体上的若干标测线路，所述标测电极与所述标测线路一一对应并电连接。Optionally, the sub-electrode assembly also includes several mapping electrodes, the electrical transmission line also includes several mapping lines arranged on the electrode body, and the mapping electrodes correspond to the mapping lines one by one and electrically connected.

可选的，所述标测电极包括第一标测电极和第二标测电极，所述标测线路包括相互绝缘的第一标测线路和第二标测线路，所述第一标测电极和所述第二标测电极分别与所述第一标测线路和所述第二标测线路电连接。Optionally, the mapping electrode includes a first mapping electrode and a second mapping electrode, and the mapping line includes a first mapping line and a second mapping line insulated from each other, and the first mapping electrode and the second mapping electrode are respectively electrically connected to the first mapping line and the second mapping line.

可选的，至少一条所述标测线路的宽度介于0.02mm-0.5mm之间。例如，部分或所有的标测线路具有介于0.02mm-0.5mm之间的宽度。Optionally, the width of at least one of the mapping lines is between 0.02mm-0.5mm. For example, some or all of the mapping lines have a width between 0.02mm-0.5mm.

可选的，至少在所述标测电极用于标测时，沿所述导管的径向方向，所述标测电极与所述导管的轴线的最小距离介于5mm-20mm之间。Optionally, at least when the mapping electrode is used for mapping, the minimum distance between the mapping electrode and the axis of the catheter is between 5 mm and 20 mm along the radial direction of the catheter.

可选的，所述子电极组件中的电极和/或所述电传输线路均沿所述电极主体的延伸方向设置。Optionally, the electrodes in the sub-electrode assembly and/or the electrical transmission lines are all arranged along the extending direction of the electrode main body.

可选的，所述子电极组件中的电极沿所述电极主体的延伸方向等间距分布。Optionally, the electrodes in the sub-electrode assembly are equally spaced along the extending direction of the electrode body.

可选的，相邻两个所述电极之间的间距小于10mm。Optionally, the distance between two adjacent electrodes is less than 10mm.

可选的，至少一条所述传输主路的宽度介于0.04mm-1mm之间。例如，部分或所有的传输主路的宽度均介于0.04mm-1mm之间。Optionally, the width of at least one main transmission path is between 0.04mm-1mm. For example, the width of some or all of the transmission main roads is between 0.04mm-1mm.

可选的，第一传输支路及第二传输支路中的至少一者的宽度介于0.02mm-0.5mm之间。Optionally, the width of at least one of the first transmission branch and the second transmission branch is between 0.02mm-0.5mm.

可选的，所述电极主体包括沿所述导管的轴向由近端至远端的近端部、折叠部及远端部，所述近端部及所述远端部的至少一者上设置有所述子电极组件，所述近端部和所述远端部中的至少一者可活动地与所述导管连接，所述近端部及远端部能够沿所述导管相对移动并在所述折叠部处对折，以使所述电极主体在收缩形态和弯曲形态之间转换；Optionally, the electrode body includes a proximal portion, a folded portion, and a distal portion from the proximal end to the distal end along the axial direction of the catheter, at least one of the proximal portion and the distal portion The sub-electrode assembly is provided, at least one of the proximal part and the distal part is movably connected to the catheter, and the proximal part and the distal part can move relatively along the catheter and folding in half at the fold to transition the electrode body between a contracted configuration and a bent configuration;

所述电极主体处于所述收缩形态时，所述电极主体沿所述导管的径向向所述导管收拢；所述电极主体处于所述弯曲形态时，所述电极主体沿所述导管的径向向外扩张，以使所述近端部与所述远端部在所述折叠部处对折，形成沿所述导管之横向的错位排布。When the electrode body is in the contracted shape, the electrode body is drawn toward the catheter along the radial direction of the catheter; expanding outward, so that the proximal part and the distal part are folded in half at the folding part to form a dislocation arrangement along the lateral direction of the catheter.

可选的，所述近端部及所述远端部上均设置有所述子电极组件，所述子电极组件包括设置在所述近端部的近端子电极组件及设置在所述远端的远端子电极组件，所述电极主体包括相对设置的内侧面及外侧面，所述内侧面为所述电极主体面向于所述导管的表面，所述外侧面为所述电极主体背离所述导管的表面：Optionally, both the proximal part and the distal part are provided with the sub-electrode assembly, and the sub-electrode assembly includes a proximal terminal electrode assembly disposed at the proximal part and a terminal electrode assembly disposed at the distal end. The electrode assembly of the distal terminal, the electrode body includes an inner side and an outer side oppositely arranged, the inner side is the surface of the electrode body facing the catheter, and the outer side is the electrode body facing away from the catheter s surface:

所述近端子电极组件及所述远端子电极组件均位于所述内侧面上；或者，Both the proximal terminal electrode assembly and the distal terminal electrode assembly are located on the inner side; or,

所述近端子电极组件及所述远端子电极组件均位于所述外侧面上；或者，Both the proximal terminal electrode assembly and the distal terminal electrode assembly are located on the outer side; or,

所述近端子电极组件位于所述内侧面上，所述远端子电极组件位于所述外侧面上；或者，The proximal terminal electrode assembly is located on the inner side and the distal terminal electrode assembly is located on the outer side; or,

所述近端子电极组件位于所述外侧面上，所述远端子电极组件位于所述内侧面上。The proximal terminal electrode assembly is located on the outer side, and the distal terminal electrode assembly is located on the inner side.

可选的，所述电极主体处于所述弯曲形态时，所述近端子电极组件中的电极与所述远端子电极组件中的电极(例如，在所述导管的横截面方向上)错位分布或并排设置。Optionally, when the electrode main body is in the curved shape, the electrodes in the proximal terminal electrode assembly and the electrodes in the distal terminal electrode assembly (for example, in the cross-sectional direction of the catheter) are misaligned or Set side by side.

可选的，所述折叠部具有凹槽，以使所述电极主体处于所述弯曲形态时，所述远端子电极组件和所述近端子电极组件位于同一平面上。Optionally, the folded portion has a groove, so that when the electrode body is in the bent configuration, the distal terminal electrode assembly and the proximal terminal electrode assembly are located on the same plane.

基于本发明的另一个方面，本发明还提供一种电生理导管，包括如上所述的电极组件及所述导管。Based on another aspect of the present invention, the present invention also provides an electrophysiological catheter, comprising the above-mentioned electrode assembly and the catheter.

可选的，所述电生理导管包括多个所述电极组件，且多个所述电极组件沿所述导管的周向排布。Optionally, the electrophysiological catheter includes a plurality of electrode assemblies, and the plurality of electrode assemblies are arranged along the circumference of the catheter.

可选的，所述电极组件至少包括相邻的第一电极组件和第二电极组件，所述第一电极组件至少包括与所述第二电极组件的至少一部分电极的极性相反的电极。Optionally, the electrode assembly includes at least a first electrode assembly and a second electrode assembly that are adjacent, and the first electrode assembly includes at least an electrode that is opposite in polarity to at least a part of the electrodes of the second electrode assembly.

基于本发明的再一个方面，本发明还提供一种电生理***，包括如上所述的电生理导管。Based on yet another aspect of the present invention, the present invention also provides an electrophysiological system, comprising the above-mentioned electrophysiological catheter.

可选的，所述电生理***还包括能量源及控制单元，所述电生理导管的标测电极用于检测所述电生理导管的电极组件的位置信息，并将所述位置信息传输给所述控制单元，所述控制单元根据所述位置信息判断所述电极组件是否处于预定部位，若所述电极组件处于预定部位，则所述控制单元控制所述能量源向所述电极组件传输能量。Optionally, the electrophysiological system further includes an energy source and a control unit, and the mapping electrode of the electrophysiological catheter is used to detect the position information of the electrode assembly of the electrophysiological catheter, and transmit the position information to the The control unit, the control unit determines whether the electrode assembly is at a predetermined position according to the position information, and if the electrode assembly is at a predetermined position, the control unit controls the energy source to transmit energy to the electrode assembly.

综上所述，本发明提供了一种电极组件、电生理导管及电生理***，至少具有以下有益效果之一：In summary, the present invention provides an electrode assembly, an electrophysiological catheter, and an electrophysiological system, which have at least one of the following beneficial effects:

1)通过将不同消融电极的传输支路并线设置，使能量传输线路具有更大的横截面积，从而能够降低能量传输线路的阻值，提高能量传输线路的耐电流能力，同时还改善了导管的消融边界，提高了消融深度；1) By arranging the transmission branches of different ablation electrodes in parallel, the energy transmission line has a larger cross-sectional area, thereby reducing the resistance value of the energy transmission line, improving the current resistance of the energy transmission line, and improving the The ablation boundary of the catheter increases the ablation depth;

2)在相同电流设计需求下，线路合并可以降低线宽要求，有利于电生理导管的小型化，提高手术操作空间；2) Under the same current design requirements, line merging can reduce line width requirements, which is conducive to the miniaturization of electrophysiological catheters and improves the operating space;

3)通过将具有标测功能的电传输线路单独设置，保证了电生理标测的独立性，并且允许具有标测功能的电传输线路采集心电信号，同时实现组织消融的功能。换言之，在相同的设计空间占比下，提升了电生理导管的消融能力。3) By separately setting the electrical transmission line with the mapping function, the independence of electrophysiological mapping is ensured, and the electrical transmission line with the mapping function is allowed to collect ECG signals while realizing the function of tissue ablation. In other words, with the same design space ratio, the ablation capability of the electrophysiological catheter is improved.

附图说明Description of drawings

本领域的普通技术人员应当理解，提供的附图用于更好地理解本发明，而不对本发明的范围构成任何限定。Those skilled in the art should understand that the accompanying drawings are provided for better understanding of the present invention, and do not constitute any limitation to the scope of the present invention.

图1是本发明实施例提供的电极组件的线路布置示意图。Fig. 1 is a schematic diagram of the wiring arrangement of an electrode assembly provided by an embodiment of the present invention.

图2是本发明实施例提供的电极组件的结构示意图。Fig. 2 is a schematic structural diagram of an electrode assembly provided by an embodiment of the present invention.

图3是本发明实施例提供的电极组件处于收缩形态时的示意图。Fig. 3 is a schematic diagram of an electrode assembly provided by an embodiment of the present invention in a contracted state.

图4是本发明实施例提供的一种电极组件处于弯曲形态时的示意图。Fig. 4 is a schematic diagram of an electrode assembly provided by an embodiment of the present invention in a bent state.

图5是图4的俯视图。FIG. 5 is a top view of FIG. 4 .

图6是本发明实施例提供的另一种电极组件处于弯曲形态时的示意图。Fig. 6 is a schematic diagram of another electrode assembly provided in an embodiment of the present invention in a bent state.

图7是本发明实施例提供的电极组件处于中间形态时的示意图。Fig. 7 is a schematic diagram of an electrode assembly provided by an embodiment of the present invention in an intermediate state.

图8是本发明实施例提供的电极组件的折叠部的示意图，其中，电极组件处于弯曲形态。Fig. 8 is a schematic diagram of a folded portion of an electrode assembly provided by an embodiment of the present invention, wherein the electrode assembly is in a bent configuration.

附图中：In the attached picture:

100-电极组件；110-电极主体；111-近端部；112-折叠部；113-远端部；凹槽-114；120-电极；121-第一消融电极；122-第二消融电极；123-标测电极；130-标测线路；140-传输主路；141-第一传输支路；142-第二传输支路；150-近端安装部；160-远端安装部；200-导管；210-外管；220-内管。100-electrode assembly; 110-electrode body; 111-proximal part; 112-folding part; 113-distal part; groove-114; 120-electrode; 121-first ablation electrode; 122-second ablation electrode; 123-mapping electrode; 130-mapping line; 140-transmission main road; 141-first transmission branch; 142-second transmission branch; 150-near-end installation part; 160-far-end installation part; 200- Conduit; 210-outer tube; 220-inner tube.

具体实施方式detailed description

为使本发明的目的、优点和特征更加清楚，以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。此外，附图所展示的结构往往是实际结构的一部分。特别的，各附图需要展示的侧重点不同，有时会采用不同的比例。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in very simplified form and not drawn to scale, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention. In addition, the structures shown in the drawings are often a part of the actual structures. In particular, each drawing needs to display different emphases, and sometimes uses different scales.

如在本发明中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，术语“或”通常是以包括“和/或”的含义而进行使用的，术语“若干”通常是以包括“至少一个”的含义而进行使用的，术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的，此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征，除非内容另外明确指出外。As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is usually used in the sense of including "and/or", and the term "several" Usually, the term "at least one" is used in the meaning of "at least one", and the term "at least two" is usually used in the meaning of "two or more". In addition, the terms "first", "second "Two" and "third" are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Therefore, a feature defined as "first", "second", and "third" may explicitly or implicitly include one or at least two of these features, unless the content clearly states otherwise.

本文中“近端”和“远端”的定义为：“近端”通常指该医疗设备在正常操作过程中靠近操作者的一端，而“远端”通常是指该医疗设备在正常操作过程中首先进入患者体内的一端。The definitions of "proximal" and "distal" in this article are: "proximal" usually refers to the end of the medical device that is close to the operator during normal operation, and "distal" generally refers to the end of the medical device that is close to the operator during normal operation. The end that first enters the patient's body.

本发明提供一种电极组件、电生理导管及电生理***，通过将不同消融电极的传输支路并线设置，降低了消融线路的阻值，提高了消融线路的耐电流能力，同时还改善了导管的消融边界，提高了消融深度。此外，在相同电流设计需求下，线路合并可以降低线宽要求，有利于消融导管的小型化，提高手术操作空间。The invention provides an electrode assembly, an electrophysiological catheter and an electrophysiological system. By arranging the transmission branches of different ablation electrodes in parallel, the resistance value of the ablation line is reduced, the current resistance of the ablation line is improved, and the ablation line is also improved. The ablation border of the catheter increases the ablation depth. In addition, under the same current design requirements, line merging can reduce line width requirements, which is conducive to the miniaturization of ablation catheters and improves the operating space.

以下请参照附图进行描述。Please refer to the accompanying drawings for description below.

如图1-图3所示，图1是本发明实施例提供的电极组件的线路布置示意图，图2是本发明实施例提供的电极组件的结构示意图，图3是本发明实施例提供的电极组件处于收缩形态时的示意图。本实施例提供一种电极组件100，能够设置于一导管200的远端，并用于在一设备和预定部位之间传输能量，所述电极组件100包括电极主体110及布置于所述电极主体110上的子电极组件和电传输线路，所述电传输线路包括若干消融线路，所述子电极组件包括若干第一消融电极121及若干第二消融电极122，所述消融线路包括传输主路140、第一传输支路141及第二传输支路142，所述第一消融电极121和所述第二消融电极122分别与对应的所述第一传输支路141的输出端和所述第二传输支路142的输出端电连接，所述第一传输支路141的输入端与所述第二传输支路142的输入端交汇于所述传输主路140。优选的，所述消融线路通过一个电触点与电生理***的控制单元电连接。As shown in Figures 1-3, Figure 1 is a schematic diagram of the wiring arrangement of the electrode assembly provided by the embodiment of the present invention, Figure 2 is a schematic structural diagram of the electrode assembly provided by the embodiment of the present invention, and Figure 3 is the electrode assembly provided by the embodiment of the present invention Schematic of the component in its collapsed form. This embodiment provides an electrode assembly 100, which can be arranged at the distal end of a catheter 200 and used to transmit energy between a device and a predetermined site. The electrode assembly 100 includes an electrode body 110 and a The sub-electrode assembly and the electric transmission line on the top, the electric transmission line includes a number of ablation lines, the sub-electrode assembly includes a number of first ablation electrodes 121 and a number of second ablation electrodes 122, and the ablation line includes a main transmission line 140, The first transmission branch 141 and the second transmission branch 142, the first ablation electrode 121 and the second ablation electrode 122 are respectively connected to the corresponding output end of the first transmission branch 141 and the second transmission branch The output end of the branch 142 is electrically connected, and the input end of the first transmission branch 141 and the input end of the second transmission branch 142 meet at the main transmission line 140 . Preferably, the ablation circuit is electrically connected to the control unit of the electrophysiological system through an electrical contact.

应当理解的是，本实施例提供的图1中的电极数量明显少于图2中的电极数量，故图1及图2中并非为同一个电极组件的线路布置示意图和结构示意图，主要是为了更加清楚的说明本发明的技术构思，当电极的数量增多时，图1中的电传输线路的数量同样也会增多。It should be understood that the number of electrodes in FIG. 1 provided in this embodiment is obviously less than that in FIG. 2 , so FIG. 1 and FIG. 2 are not schematic diagrams of circuit layout and structure of the same electrode assembly, mainly for the purpose of To illustrate the technical concept of the present invention more clearly, when the number of electrodes increases, the number of electrical transmission lines in FIG. 1 also increases.

具体的，所述电极主体110为一柔性电路板，所述子电极组件及所述消融线路均设置于所述柔性电路板上。较佳的，所述电极主体110由绝缘材料制成，例如可以是液晶共聚物(LCP)、聚酰亚胺(PI)、聚二甲基硅氧烷(PDMS)；更优选的，电极主体110中填充有弹性镍合金，如镍钛合金。如此，可改善电极主体110的支承力。这里对镍钛合金的性能不做具体说明，本领域技术人员可如公知常识获取。需说明，本实施例中用于填充改善电极主体110支承力的材料不限于是镍钛合金，凡是起到改善电极主体110支承力，且对患者无副作用的材料均可填充至本实施所述的电极主体110中。Specifically, the electrode body 110 is a flexible circuit board, and the sub-electrode assembly and the ablation circuit are both arranged on the flexible circuit board. Preferably, the electrode body 110 is made of an insulating material, such as liquid crystal copolymer (LCP), polyimide (PI), polydimethylsiloxane (PDMS); more preferably, the electrode body 110 is filled with elastic nickel alloy, such as Nitinol. As such, the supporting force of the electrode body 110 may be improved. Here, the performance of the nickel-titanium alloy is not specifically described, and those skilled in the art can obtain it according to common knowledge. It should be noted that the material used to improve the supporting force of the electrode body 110 in this embodiment is not limited to nickel-titanium alloy, any material that improves the supporting force of the electrode body 110 and has no side effects on patients can be filled into the material described in this embodiment. in the electrode body 110.

所述第一消融电极121及第二消融电极122用于向预定部位(组织)传输能量，实现消融目的。所述第一消融电极121及第二消融电极122可用铂金或者金制成。应当理解的是，本申请中提及的“第一消融电极”及“第二消融电极”，不应理解为对消融电极的类型进行限定，也不是对消融电极的数量进行限定，而是为了更清楚的阐述本发明对不同消融电极的传输线路进行并线处理的技术构思。换言之，所述子电极组件还可以包含第三消融电极、第四消融电极甚至更多消融电极，均属于本发明的保护范围。在以下叙述中，所述第一消融电极121及第二消融电极122统称为消融电极。The first ablation electrode 121 and the second ablation electrode 122 are used to transmit energy to predetermined parts (tissues) to achieve the purpose of ablation. The first ablation electrode 121 and the second ablation electrode 122 can be made of platinum or gold. It should be understood that the "first ablation electrode" and "second ablation electrode" mentioned in this application should not be understood as limiting the type of ablation electrodes, nor the number of ablation electrodes, but for The technical idea of paralleling the transmission lines of different ablation electrodes in the present invention is more clearly described. In other words, the sub-electrode assembly may further include a third ablation electrode, a fourth ablation electrode or even more ablation electrodes, all of which belong to the protection scope of the present invention. In the following description, the first ablation electrode 121 and the second ablation electrode 122 are collectively referred to as ablation electrodes.

较佳的，对于肺静脉口面积较小的消融部位，可设置一径向尺寸较大的所述消融电极便可进行消融处理，如此可节省材料。本发明对所述消融电极的形状(这里可理解为消融电极的横截面)不做具体限制，可以是圆形、椭圆形、多边形、不规则的平面形等；这里的径向尺寸，可理解为最大径向尺寸，即所述消融电极边缘之间的最大距离，当所述消融电极的横截面是圆形时，径向尺寸则为直径。Preferably, for the ablation site with a small area of the pulmonary vein ostium, the ablation electrode with a larger radial dimension can be provided for ablation treatment, which can save materials. The present invention does not specifically limit the shape of the ablation electrode (here it can be understood as the cross section of the ablation electrode), which can be circular, elliptical, polygonal, irregular plane, etc.; the radial dimension here can be understood is the maximum radial dimension, that is, the maximum distance between the edges of the ablation electrodes, and when the cross section of the ablation electrodes is circular, the radial dimension is the diameter.

需说明，这里的所述消融电极，可以是套设于所述电极主体110上的环形电极，也可以自所述电极主体110的表面凸出形成的片形电极。所述消融电极优选为片形，大致上呈帽子状或者类似螺钉状，嵌设于电极主体110中。在使用时，可将所述消融电极与预定部位贴靠。片形电极相较于环形电极的接触面积更大。如此配置，片形电极可避免电极主体110与预定部位抵靠(由于片形电极自电极主体110的表面凸出)，减少预定部位(肺静脉)受到的压应力，进而可使肺静脉内的血液正常流通，降低热效应对消融治疗的影响。It should be noted that the ablation electrode here may be a ring-shaped electrode sleeved on the electrode body 110 , or a sheet-shaped electrode protruding from the surface of the electrode body 110 . The ablation electrode is preferably in the shape of a sheet, roughly in the shape of a hat or similar to a screw, and is embedded in the electrode body 110 . When in use, the ablation electrode can be attached to a predetermined site. The sheet electrode has a larger contact area than the ring electrode. With such configuration, the sheet-shaped electrode can prevent the electrode body 110 from abutting against the predetermined site (because the sheet-shaped electrode protrudes from the surface of the electrode body 110), reduce the compressive stress on the predetermined site (pulmonary vein), and then make the blood in the pulmonary vein normal. Circulation, reducing the impact of thermal effects on ablation therapy.

优选的，所述消融电极具有凸缘，这里对凸缘的延伸方向不做具体限制。较佳地，凸缘沿所述传输线路的方向延伸，所述凸缘被一覆盖层覆盖在所述传输支路上，以限制所述消融电极于所述传输支路上的位置，加强所述消融电极的固定，防止脱落，提高安全性。可选的，覆盖层可由聚酰亚胺或LCP(液晶聚合物)制成。或者，覆盖层也可以是固化胶水，胶水仅覆盖凸缘，以与电极主体110粘接。Preferably, the ablation electrode has a flange, and the extending direction of the flange is not specifically limited here. Preferably, the flange extends along the direction of the transmission line, and the flange is covered by a covering layer on the transmission branch, so as to limit the position of the ablation electrode on the transmission branch and strengthen the ablation The electrode is fixed to prevent falling off and improve safety. Alternatively, the cover layer can be made of polyimide or LCP (Liquid Crystal Polymer). Alternatively, the covering layer may also be cured glue, and the glue only covers the flange for bonding with the electrode main body 110 .

请继续参照图1，所述消融线路包括传输主路140、第一传输支路141及第二传输支路142，所述第一消融电极121和所述第二消融电极122分别与所述第一传输支路141的输出端和所述第二传输支路142的输出端电连接，所述第一传输支路141的输入端与所述第二传输支路142的输入端交汇于所述传输主路140。也就是说，本实施例中，所述第一传输支路141与所述第二传输支路142汇合于一条消融主路(传输主路)与电生理***的控制单元电连接，以通过控制单元控制能量源向所述子电极组件传输能量或接收从所述子电极组件反馈的信号。通过将与不同消融电极电连接的多条传输线路进行并线处理，与常规的能量传输线路相比，具有更大的横截面积，从而能够降低能量传输线路的阻值，提高能量传输线路的耐电流能力，增强消融效果；也有利于消融导管200的小型化，提高手术操作空间。Please continue to refer to FIG. 1 , the ablation circuit includes a transmission main circuit 140, a first transmission branch 141, and a second transmission branch 142, and the first ablation electrode 121 and the second ablation electrode 122 are connected to the first ablation electrode 122 respectively. The output end of a transmission branch 141 is electrically connected to the output end of the second transmission branch 142, and the input end of the first transmission branch 141 and the input end of the second transmission branch 142 meet at the Transmission main road 140. That is to say, in this embodiment, the first transmission branch 141 and the second transmission branch 142 merge into one ablation main circuit (transmission main circuit) and are electrically connected to the control unit of the electrophysiological system, so as to control The unit controls the energy source to transmit energy to the sub-electrode assembly or receive a signal fed back from the sub-electrode assembly. By paralleling multiple transmission lines electrically connected to different ablation electrodes, compared with conventional energy transmission lines, it has a larger cross-sectional area, thereby reducing the resistance of the energy transmission line and improving the energy transmission line. The ability to withstand current enhances the ablation effect; it is also conducive to the miniaturization of the ablation catheter 200 and improves the operation space.

应当理解的是，本申请对于所述消融线路的数量不作限制。优选的，考虑到更多的消融线路必然导致更大的电极主体110，不利于消融导管200的小型化，故所述消融线路的数量不大于六条，且各消融线路之间相互独立。且当所述消融线路分别布置于所述电极主体110相对的内外侧面时，同一侧面上的消融线路不大于三条。It should be understood that the present application does not limit the number of the ablation lines. Preferably, considering that more ablation lines will inevitably lead to a larger electrode body 110, which is not conducive to the miniaturization of the ablation catheter 200, the number of the ablation lines is not more than six, and the ablation lines are independent of each other. And when the ablation lines are arranged on the opposite inner and outer sides of the electrode body 110, there are no more than three ablation lines on the same side.

较佳的，至少一条所述传输主路的宽度介于0.04mm-1mm之间。理论上，线路的宽度都应尽量设置越大越好以满足消融的电流能力需求。但是，由于导管需要通过血管进入人体，所以线路的设计尽量小，以减小线路层的设计体积。可以通过将至少一条(例如，部分或全部的)传输主路的宽度设计在0.04mm-1mm的范围内，既能满足消融的电流要求，又能节省设计空间。当然，所述传输主路的宽度也可以小于0.04mm或大于1mm，本申请对此不作限制。第一传输支路及第二传输支路中的宽度介于0.02mm-0.5mm之间。理论上，线路的宽度都应尽量设置越大越好以满足消融的电流能力需求。但是，由于导管需要通过血管进入人体，所以线路的设计尽量小，以减小线路层的设计体积。可以通过将至少一条(例如，部分或全部的)传输支路的宽度设计在0.02mm-0.5mm的范围内，既能满足消融的电流要求，又能节省设计空间。当然，第一传输支路及第二传输支路中的宽度也可以小于0.02mm或大于0.5mm，本申请对此也不作限制。Preferably, the width of at least one main transmission path is between 0.04mm-1mm. Theoretically, the width of the line should be set as large as possible to meet the current capacity requirements of ablation. However, since the catheter needs to enter the human body through blood vessels, the design of the circuit should be as small as possible to reduce the design volume of the circuit layer. By designing the width of at least one (for example, part or all) of the main transmission path within the range of 0.04mm-1mm, the current requirement for ablation can be met and the design space can be saved. Of course, the width of the main transmission path may also be less than 0.04 mm or greater than 1 mm, which is not limited in the present application. The widths of the first transmission branch and the second transmission branch are between 0.02mm-0.5mm. Theoretically, the width of the line should be set as large as possible to meet the current capacity requirements of ablation. However, since the catheter needs to enter the human body through blood vessels, the design of the circuit should be as small as possible to reduce the design volume of the circuit layer. By designing the width of at least one (for example, part or all) of the transmission branch within the range of 0.02mm-0.5mm, the current requirement for ablation can be met and the design space can be saved. Of course, the widths of the first transmission branch and the second transmission branch may also be smaller than 0.02 mm or larger than 0.5 mm, which is not limited in the present application.

进一步的，每条消融线路上的传输支路还可以大于两条。应当注意的是，每条传输支路对应一个消融电极，且位于同一消融线路上的所有消融电极的极性应当相同。例如，请参照图1，第一消融电极121及第二消融电极122的极性相同。不同的消融线路上的消融电极的极性可以相同，也可以不同，本申请对此不作任何限制。Further, each ablation line may have more than two transmission branches. It should be noted that each transmission branch corresponds to an ablation electrode, and the polarity of all ablation electrodes on the same ablation line should be the same. For example, referring to FIG. 1 , the first ablation electrode 121 and the second ablation electrode 122 have the same polarity. The polarities of the ablation electrodes on different ablation lines may be the same or different, and this application does not impose any limitation on this.

请继续参照图1，所述子电极组件还包括若干标测电极123，所述电传输线路还包括布置于所述电极主体110上的若干标测线路130，所述标测电极123与所述标测线路130一一对应并电连接。所述标测线路130与所述消融线路相互绝缘。所述标测电极123用于检测所述电生理导管的电极组件100的位置信息，并将所述位置信息传输给所述控制单元，所述控制单元根据所述位置信息判断所述电极组件是否处于预定部位，若所述电极组件处于预定部位，则所述控制单元控制所述能量源向子电极组件传输能量，对所述预定部位进行消融。同时，所述标测电极123也可用于组织消融。通过将需要具有标测功能的标测线路130与消融线路单独设置，保证了电生理标测的独立性，并允许标测线路130不仅可采集心电信号，同时也可实现组织消融的功能。换言之，在相同的设计空间占比下，提升了导管的消融能力。Please continue to refer to FIG. 1, the sub-electrode assembly also includes a number of mapping electrodes 123, and the electrical transmission line also includes a number of mapping lines 130 arranged on the electrode body 110, the mapping electrodes 123 and the The mapping lines 130 are in one-to-one correspondence and electrically connected. The mapping line 130 is insulated from the ablation line. The mapping electrode 123 is used to detect the position information of the electrode assembly 100 of the electrophysiological catheter, and transmit the position information to the control unit, and the control unit judges whether the electrode assembly is At a predetermined position, if the electrode assembly is at the predetermined position, the control unit controls the energy source to transmit energy to the sub-electrode assembly to ablate the predetermined position. Meanwhile, the mapping electrode 123 can also be used for tissue ablation. By separately setting the mapping circuit 130 and the ablation circuit that need to have the mapping function, the independence of electrophysiological mapping is ensured, and the mapping circuit 130 can not only collect ECG signals, but also realize the function of tissue ablation. In other words, with the same design space ratio, the ablation capability of the catheter is improved.

本实施例中，所述标测电极123为两个，两个所述标测电极123分别为第一标测电极和第二标测电极，所述标测线路130包括相互绝缘的第一标测线路和第二标测线路，所述第一标测电极和所述第二标测电极分别与所述第一标测线路和所述第二标测线路电连接。两条所述标测线路130之间相互独立，并分别与电生理***的控制单元电连接，以获取范围更广的位置信息。对于所述标测电极的形状及尺寸的限定，请参照上述对消融电极的描述，这里不再一一赘述。In this embodiment, there are two mapping electrodes 123, and the two mapping electrodes 123 are respectively a first mapping electrode and a second mapping electrode, and the mapping line 130 includes first marking electrodes insulated from each other. A survey line and a second survey line, the first survey electrode and the second survey electrode are electrically connected to the first survey line and the second survey line, respectively. The two mapping lines 130 are independent of each other, and are respectively electrically connected to the control unit of the electrophysiological system, so as to obtain a wider range of position information. For the definition of the shape and size of the mapping electrode, please refer to the above description of the ablation electrode, which will not be repeated here.

较佳的，至少在所述标测电极123用于标测时，所述标测电极123与所述导管的轴线的最小距离介于5mm-20mm之间，可改善标测电极123与组织的贴靠程度，提高标测的可靠性。当然，可以理解的是，当所述电极载体110 处于收缩状态或其他中间状态时，所述标测电极123与所述导管220的轴线的最小距离也可以介于5mm-20mm之间，也可以大于20mm或小于5mm，本申请对此不作任何限制。Preferably, at least when the mapping electrode 123 is used for mapping, the minimum distance between the mapping electrode 123 and the axis of the catheter is between 5mm-20mm, which can improve the relationship between the mapping electrode 123 and the tissue. The degree of closeness improves the reliability of mapping. Of course, it can be understood that, when the electrode carrier 110 is in a contracted state or other intermediate states, the minimum distance between the mapping electrode 123 and the axis of the catheter 220 may also be between 5mm-20mm, or greater than 20mm or less than 5mm, the present application does not make any limitation on this.

请继续参照图2，所述子电极组件中的电极120和/或所述电传输线路均沿所述电极主体110的延伸方向设置，以减小所述子电极组件及电传输线路的占用空间，有利于电极主体110的小型化。也就是说，所述电极主体110的形态决定了所述子电极组件中电极120的排布方式，例如，所述电极主体110的形态可以为直线型、折线型或弯曲型，本申请对此不作任何限制。Please continue to refer to FIG. 2 , the electrodes 120 and/or the electrical transmission lines in the sub-electrode assembly are arranged along the extension direction of the electrode body 110 to reduce the occupied space of the sub-electrode assembly and the electrical transmission line. , which is beneficial to the miniaturization of the electrode body 110 . That is to say, the shape of the electrode body 110 determines the arrangement of the electrodes 120 in the sub-electrode assembly. For example, the shape of the electrode body 110 can be linear, zigzag, or curved. No restrictions are imposed.

较佳的，所述子电极组件中的电极120沿所述电极主体110的延伸方向等间距分布，以便于更好地对预定部位进行消融。需要注意的是，对于本文中提及的子电极组件中的电极120，所述电极120可以指代所述第一消融电极121及所述第二消融电极122，也可以指代所述标测电极123。Preferably, the electrodes 120 in the sub-electrode assembly are distributed at equal intervals along the extension direction of the electrode body 110, so as to better ablate predetermined positions. It should be noted that, for the electrode 120 in the sub-electrode assembly mentioned herein, the electrode 120 may refer to the first ablation electrode 121 and the second ablation electrode 122, or may refer to the mapping electrode 123 .

优选的，相邻两个所述电极之间的间距(沿电传输线路方向)小于10mm。相邻的两个电极可以是两个所述第一消融电极、两个所述第二消融电极、两个所述标测电极或所述第一消融电极、第二消融电极及标测电极123中任意两者的组合。Preferably, the distance between two adjacent electrodes (along the direction of the electrical transmission line) is less than 10mm. The two adjacent electrodes may be the two first ablation electrodes, the two second ablation electrodes, the two mapping electrodes or the first ablation electrode, the second ablation electrode and the mapping electrode 123 any combination of the two.

本实施例中，所述电传输线路包括消融线路及所述标测线路130，所述消融线路及所述标测线路130均沿所述电极主体110的延伸方向设置。换言之，所述消融线路及所述标测线路130的走向与所述电极主体110的形态大致相同，以尽量减小所述消融线路及所述标测线路130所占用的空间，有利于消融导管200的小型化。In this embodiment, the electrical transmission line includes an ablation line and the mapping line 130 , and both the ablation line and the mapping line 130 are arranged along the extension direction of the electrode body 110 . In other words, the direction of the ablation line and the mapping line 130 is approximately the same as the shape of the electrode body 110, so as to minimize the space occupied by the ablation line and the mapping line 130, which is beneficial to the ablation catheter 200 miniaturization.

进一步的，所述标测线路130的数量不大于六条，且各标测线路130之间相互独立。且当所述标测线路130分别布置所述电极主体110相对的内外侧面时，同一侧面上的标测线路130不大于三条。本实施例中，所述标测线路130的数量为两条，每条标测线路130对应一个标测电极123，两条所述标测线路130之间相互独立，并分别与电生理***的控制单元电连接。这保证了电生理标测的独立性，可允许标测线路采集心电信号，同时实现组织消融的功能。Further, the number of the mapping lines 130 is no more than six, and each mapping line 130 is independent of each other. And when the mapping lines 130 are arranged on the opposite inner and outer sides of the electrode body 110 , there are no more than three mapping lines 130 on the same side. In this embodiment, the number of the mapping lines 130 is two, and each mapping line 130 corresponds to a mapping electrode 123, and the two mapping lines 130 are independent of each other, and are respectively connected with the electrophysiological system. The control unit is electrically connected. This ensures the independence of electrophysiological mapping, allows the mapping circuit to collect ECG signals, and realizes the function of tissue ablation at the same time.

当然，对不同的部位进行消融时，所述消融线路及所述标测线路130的数量要求也不同。例如，用于对肺静脉进行消融的电极组件100，同一侧面上的消融线路及标测线路130均不大于两条。Of course, when ablation is performed on different parts, the quantity requirements of the ablation lines and the mapping lines 130 are also different. For example, in the electrode assembly 100 used for ablation of pulmonary veins, there are no more than two ablation lines and mapping lines 130 on the same side.

较佳的，所述标测线路130的宽度介于0.02mm-0.5mm之间。理论上，线路的宽度都应尽量设置越大越好以满足消融的电流能力需求。但是，由于导管需要通过血管进入人体，所以线路的设计尽量小，以减小线路层的设计体积。可以通过将至少一条(例如，部分或全部的)标测线路130的宽度设计在0.02mm-0.5mm的范围内，既能满足标测消融的电流要求，又能节省设计空间。当然，所述标测线路130的宽度也可以小于0.02mm或大于0.5mm，本申请对此不作限制。Preferably, the width of the mapping line 130 is between 0.02mm-0.5mm. Theoretically, the width of the line should be set as large as possible to meet the current capacity requirements of ablation. However, since the catheter needs to enter the human body through blood vessels, the design of the circuit should be as small as possible to reduce the design volume of the circuit layer. By designing the width of at least one (for example, part or all) of the mapping lines 130 within the range of 0.02mm-0.5mm, the current requirement of the mapping ablation can be met and the design space can be saved. Certainly, the width of the mapping line 130 may also be less than 0.02 mm or greater than 0.5 mm, which is not limited in the present application.

较佳的，所述子电极组件中的相邻两个电极120的电传输线路之间的间距(沿电传输线路方向的间距)介于0.02mm-0.5mm之间。这里的电传输线路与各个所述电极120的电传输线路相对应，例如消融电极对应消融线路，标测电极123对应标测线路130。优选的，当所述预定部位为肺静脉时，所述子电极组件中的相邻两个电极120的电传输线路之间的间距介于0.05mm-0.2mm之间。Preferably, the distance between the electric transmission lines of two adjacent electrodes 120 in the sub-electrode assembly (the distance along the direction of the electric transmission line) is between 0.02mm-0.5mm. The electrical transmission lines here correspond to the electrical transmission lines of the electrodes 120 , for example, the ablation electrodes correspond to the ablation lines, and the mapping electrodes 123 correspond to the mapping lines 130 . Preferably, when the predetermined location is the pulmonary vein, the distance between the electrical transmission lines of two adjacent electrodes 120 in the sub-electrode assembly is between 0.05mm-0.2mm.

请参照图2-图4，图2是本发明实施例提供的电极组件的结构示意图。所述电极主体110包括沿所述导管200的轴向由近端至远端的近端部111、折叠部112及远端部113，所述近端部111及所述远端部113中的至少一者上设置有所述子电极组件，所述近端部111和所述远端部113中的至少一者可活动地与所述导管200连接，所述近端部111及远端部113能够沿所述导管200相对移动并在所述折叠部112处对折，以使所述电极主体110在收缩形态和弯曲形态之间转换；Please refer to FIG. 2-FIG. 4. FIG. 2 is a schematic structural diagram of an electrode assembly provided by an embodiment of the present invention. The electrode body 110 includes a proximal portion 111, a folded portion 112, and a distal portion 113 extending from the proximal end to the distal end along the axial direction of the catheter 200, and the proximal portion 111 and the distal portion 113 are At least one of the sub-electrode assemblies is provided, at least one of the proximal portion 111 and the distal portion 113 is movably connected to the catheter 200, and the proximal portion 111 and the distal portion 113 can move relatively along the catheter 200 and fold in half at the folding portion 112, so that the electrode body 110 can be converted between a contracted configuration and a curved configuration;

所述电极主体110处于所述收缩形态时，所述电极主体110沿所述导管200的径向向所述导管200收拢；When the electrode body 110 is in the contracted state, the electrode body 110 is retracted toward the catheter 200 along the radial direction of the catheter 200;

所述电极主体110处于所述弯曲形态时，所述电极主体110沿所述导管200的径向向外扩张，以使所述近端部111与所述远端部113在所述折叠部112处对折，形成沿所述导管200之横向的错位排布。When the electrode body 110 is in the bent shape, the electrode body 110 expands outward along the radial direction of the catheter 200 , so that the proximal end portion 111 and the distal end portion 113 are in the folded portion 112 Fold in half to form a dislocation arrangement along the lateral direction of the catheter 200 .

请继续参照图3，图3是本发明实施例提供的电极组件处于收缩形态时的示意图。所述电极主体110处于所述收缩形态时，所述电极主体110沿所述导管200的径向向内贴靠于所述导管200上(贴靠于导管200之外壁)；请参照图4，图4是本发明实施例提供的一种电极组件处于弯曲形态时的示意图，所述电极主体110处于所述弯曲形态时，所述电极主体110沿所述导管200的径向向外扩张，以使所述近端部111与所述远端部113在所述折叠部112处对折，形成沿所述导管200之横向的错位排布。需理解，在近端部111和远端部113发生相对移动时，所述近端部111和所述远端部113各自朝向对方的一端沿导管200之径向向外移动，使近端部111和远端部113分别与导管200之轴向成角度地布置；这里的弯曲形态指的是最大弯曲形态，即近端部111和远端部113的靠近导管的轴线的部分大致上相抵靠(若二者之间有些许间隙，可忽略不计)；近端部111和远端部113相向倾斜，指的是二者各自朝向对方倾斜；更具体的，沿导管200之横向，近端部111和远端部113二者成角度布置；沿导管200之轴向，近端部111和远端部113二者不重合。如此实现近端部111和远端部113均与预定部位抵靠，增加接触面积；导管200之横向，指大致沿导管200之横截面的方向，导管200之轴向，应理解为大致沿导管200的延伸方向(包括弯曲或折线的情况)。Please continue to refer to FIG. 3 . FIG. 3 is a schematic diagram of the electrode assembly provided by an embodiment of the present invention in a contracted state. When the electrode main body 110 is in the contracted state, the electrode main body 110 abuts on the catheter 200 inwardly along the radial direction of the catheter 200 (close to the outer wall of the catheter 200); please refer to FIG. 4 , 4 is a schematic diagram of an electrode assembly provided in an embodiment of the present invention when it is in a bent shape. When the electrode body 110 is in the bent shape, the electrode body 110 expands outward along the radial direction of the catheter 200 to The proximal portion 111 and the distal portion 113 are folded in half at the folding portion 112 to form a dislocation arrangement along the transverse direction of the catheter 200 . It should be understood that when the proximal portion 111 and the distal portion 113 move relative to each other, the respective ends of the proximal portion 111 and the distal portion 113 move outward along the radial direction of the catheter 200, so that the proximal portion 111 and the distal portion 113 are respectively arranged at an angle to the axial direction of the catheter 200; the curved shape here refers to the maximum curved shape, that is, the portions of the proximal portion 111 and the distal portion 113 that are close to the axis of the catheter are substantially abutted against (If there is a slight gap between the two, it can be ignored); the proximal part 111 and the distal part 113 are inclined to each other, which means that the two are inclined towards each other; more specifically, along the transverse direction of the catheter 200, the proximal part Both the proximal portion 111 and the distal portion 113 are arranged at an angle; along the axial direction of the catheter 200, the proximal portion 111 and the distal portion 113 do not coincide. In this way, both the proximal end portion 111 and the distal end portion 113 are abutted against the predetermined position to increase the contact area; the transverse direction of the catheter 200 refers to the direction roughly along the cross-section of the catheter 200, and the axial direction of the catheter 200 should be understood to be roughly along the direction of the catheter 200. The extension direction of 200 (including the case of bending or folding line).

现有技术中用于消融的结构(结构大致上类似于本实施例中的电极组件100，即大致上呈线状。以下以消融电极组件命名现有技术中的用于消融的结构)是多个环电极依次排布于高分子管材上所形成的，消融电极组件通过导管推送后，将导管的远端扭转，从而实现消融电极组件的扭转，进而形成消融电极组件的错位排布。现有技术中，传统高分子管材/环电极占位较大，导致消融电极组件的密度受限。此外，扭转后的消融电极组件抗扭转性能较差而无法使消融电极组件贴靠至预定部位的面积最大化。这既影响消融深度，又影响消融电极组件的高密度标测的准确性。The structure used for ablation in the prior art (the structure is roughly similar to the electrode assembly 100 in this embodiment, that is, roughly linear. The structure used for ablation in the prior art is named after the ablation electrode assembly) is many The ring electrodes are sequentially arranged on the polymer tubing. After the ablation electrode assembly is pushed through the catheter, the distal end of the catheter is twisted to realize the twisting of the ablation electrode assembly, thereby forming a dislocation arrangement of the ablation electrode assembly. In the prior art, the traditional polymer tubing/ring electrode occupies a large area, resulting in a limited density of the ablation electrode assembly. In addition, the anti-twisting performance of the twisted ablation electrode assembly is poor, so the area where the ablation electrode assembly abuts to the predetermined position cannot be maximized. This not only affects the ablation depth, but also affects the accuracy of high-density mapping of the ablation electrode assembly.

而本实施例中，请参照图4，所述电极主体110还包括折叠部112，所述折叠部112分别与所述近端部111和所述远端部113连接。通过使所述近端部111及远端部113沿所述导管200的轴向相向移动并在所述折叠部112处对折，最终实现近端部111和远端部113形成折叠状的错位排布，避免电极组件扭转而影响电极主体110与预定部位之间的贴靠面积，从而改善预定部位周围的电场，提升消融效果。In this embodiment, please refer to FIG. 4 , the electrode body 110 further includes a folded portion 112 , and the folded portion 112 is respectively connected to the proximal portion 111 and the distal portion 113 . By moving the proximal portion 111 and the distal portion 113 toward each other along the axial direction of the catheter 200 and folding them in half at the folding portion 112, the proximal portion 111 and the distal portion 113 form a folded dislocation row. cloth, so as to prevent the electrode assembly from twisting and affect the contact area between the electrode body 110 and the predetermined part, thereby improving the electric field around the predetermined part and improving the ablation effect.

此外，请参照图6，图6是本发明实施例提供的另一种电极组件处于弯曲形态时的示意图，所述电极组件100为展开的立体状态，也可以用于消融。应当理解的是，图6对应的电极组件100中不包含所述折叠部112。In addition, please refer to FIG. 6 . FIG. 6 is a schematic diagram of another electrode assembly provided in an embodiment of the present invention when it is in a bent state. The electrode assembly 100 is in a three-dimensional unfolded state and can also be used for ablation. It should be understood that the electrode assembly 100 corresponding to FIG. 6 does not include the folding portion 112 .

较佳的，所述折叠部112可用绝缘材料制成。Preferably, the folded portion 112 can be made of insulating material.

较佳的，所述折叠部112具有凹槽114，所述电极主体110处于所述弯曲形态时，所述凹槽114用于容置所述近端部111或所述远端部113，如此，可以使电极主体110处于弯曲形态时，近端部111和远端部113大致上在同一平面(曲面)上，便于与预定部位贴靠。Preferably, the folded part 112 has a groove 114, and when the electrode body 110 is in the bent shape, the groove 114 is used to accommodate the proximal part 111 or the distal part 113, so Therefore, when the electrode main body 110 is in a bent shape, the proximal end portion 111 and the distal end portion 113 are substantially on the same plane (curved surface), which is convenient for adhering to a predetermined position.

较佳的，请继续参照图2，并结合图3和图4，所述近端部111和所述远端部113中的至少一者呈弧形或折线形。如此设置，可使电极主体110处于弯曲形态时，减少近端部111和远端部113的叠合部分，优化两者的排布方式。较佳的，所述近端部111和所述远端部113均呈弧形或折线形，且所述近端部111和所述远端部113两者的开口方向沿所述导管200之横向相反。如此配置，可使电极主体110收缩形态时，电极主体110大致上呈“S”形，处于弯曲形态时，“S”的下部分翻折上去与上部分抵靠，使电极主体110大致上呈花瓣状。需要理解的是，这里的折线形，指的是若干折线段沿导管200之轴向依次连接，相邻的两个折线段之间的连接角度较小，可忽略不计(例如5°)，若干折线段依次连接后，整体上大致也可理解为呈弧形。Preferably, please continue to refer to FIG. 2 , and in combination with FIG. 3 and FIG. 4 , at least one of the proximal portion 111 and the distal portion 113 is in the shape of an arc or a broken line. With such arrangement, when the electrode main body 110 is in a bent shape, the overlapping portions of the proximal portion 111 and the distal portion 113 can be reduced, and the arrangement of the two can be optimized. Preferably, both the proximal portion 111 and the distal portion 113 are arc-shaped or zigzag-shaped, and the opening directions of both the proximal portion 111 and the distal portion 113 are along the direction of the catheter 200 Horizontal opposite. Such configuration can make the electrode body 110 in a contracted form, the electrode body 110 is roughly "S"-shaped, and in a bent shape, the lower part of the "S" is folded up and abuts against the upper part, so that the electrode body 110 is roughly in the shape of an "S". Petal shaped. It should be understood that the broken-line shape here refers to that several broken-line segments are sequentially connected along the axial direction of the catheter 200, and the connection angle between two adjacent broken-line segments is small and negligible (for example, 5°). After the polyline segments are connected in sequence, they can also be generally understood as being arc-shaped as a whole.

多个所述子电极组件中的电极120沿所述近端部111的延伸方向间隔地设置于所述近端部111，和/或，多个所述子电极组件中的电极沿所述远端部113的延伸方向间隔地设置于所述远端部113。通过调节所述子电极组件中电极120的数量，改变电极的密度，同时适当的设置标测电极123，可实现电极组件100的高密度标测功能，以辅助采集预定部位的生理信号。The electrodes 120 in the plurality of sub-electrode assemblies are arranged on the proximal portion 111 at intervals along the extending direction of the proximal portion 111, and/or, the electrodes in the plurality of sub-electrode assemblies are arranged along the extension direction of the distal portion 111. The extending direction of the end portion 113 is arranged on the distal end portion 113 at intervals. By adjusting the number of electrodes 120 in the sub-electrode assembly, changing the density of the electrodes, and setting the mapping electrodes 123 appropriately, the high-density mapping function of the electrode assembly 100 can be realized to assist in collecting physiological signals at predetermined locations.

本实施例中，所述近端部111及所述远端部113上均设置有所述子电极组件，以提升消融深度，提高高密度标测的准确性。所述子电极组件包括设置在所述近端部111的近端子电极组件及设置在所述远端的远端子电极组件，所述近端子电极组件及所述远端子电极组件位于所述电极主体110相对的两个侧面上，以使所述电极主体110处于所述弯曲形态时，所述近端子电极组件及所述远端子电极组件均朝向所述导管200的远端。In this embodiment, the sub-electrode assembly is provided on both the proximal portion 111 and the distal portion 113 to enhance the ablation depth and improve the accuracy of high-density mapping. The sub-electrode assembly includes a proximal electrode assembly disposed at the proximal portion 111 and a distal electrode assembly disposed at the distal end, the proximal electrode assembly and the distal electrode assembly are located on the electrode body 110 on two opposite sides, so that when the electrode main body 110 is in the bent shape, the proximal terminal electrode assembly and the distal terminal electrode assembly both face the distal end of the catheter 200 .

较佳的，所述电极主体110呈带状，类似平面状(例如，长方形)。位于所述近端部111的所述子电极组件和位于所述远端部113的所述子电极组件分布于所述电极主体110的两面。在一个示范性的实施例中，所述电极主体110处于收缩形态时，所述电极主体110垂直于导管200之径向(即所述电极主体110沿导管200之轴向延伸)，位于近端部111的所述子电极组件分布于所述电极主体110的内侧面，位于远端部113的所述子电极组件分布于所述电极主体110的外侧面。当所述电极主体110处于弯曲形态时，所述子电极组件中的电极120均朝向远端；在另一个示范性的实施例中，所述电极主体110处于收缩形态时，位于近端部111的所述子电极组件分布于所述电极主体110的外侧面，位于远端部113的所述子电极组件分布于所述电极主体110的内侧面。当所述电极主体110处于弯曲形态时，所述子电极组件的电极120均朝向近端。这里，所述电极主体110的内侧面，指的是电极主体110靠近所述导管200的一面；电极主体110的外侧面，指的是电极主体110背离所述导管200的一面。本领域技术人员可根据预定部位在病理人员的实际位置，配置所述子电极组件分布于电极主体110的外侧面或内侧面。Preferably, the electrode body 110 is strip-shaped, similar to a plane (eg, rectangular). The sub-electrode assembly at the proximal end 111 and the sub-electrode assembly at the distal end 113 are distributed on both sides of the electrode body 110 . In an exemplary embodiment, when the electrode body 110 is in a contracted state, the electrode body 110 is perpendicular to the radial direction of the catheter 200 (that is, the electrode body 110 extends along the axial direction of the catheter 200 ), and is located at the proximal end. The sub-electrode assemblies at the part 111 are distributed on the inner surface of the electrode body 110 , and the sub-electrode assemblies at the distal end 113 are distributed on the outer surface of the electrode body 110 . When the electrode main body 110 is in a bent form, the electrodes 120 in the sub-electrode assembly are all facing the distal end; in another exemplary embodiment, when the electrode main body 110 is in a contracted form, it is located at the proximal end 111 The sub-electrode assemblies are distributed on the outer surface of the electrode body 110 , and the sub-electrode assemblies located at the distal end 113 are distributed on the inner surface of the electrode body 110 . When the electrode main body 110 is in a bent shape, the electrodes 120 of the sub-electrode assembly are all facing the proximal end. Here, the inner side of the electrode body 110 refers to the side of the electrode body 110 close to the catheter 200 ; the outer side of the electrode body 110 refers to the side of the electrode body 110 away from the catheter 200 . Those skilled in the art can configure the sub-electrode assemblies distributed on the outer surface or the inner surface of the electrode body 110 according to the actual location of the predetermined location in the pathologist.

在其他一些实施例中，在收缩形态时，不限于电极主体110垂直于导管200之径向，还可以是电极主体110与导管200成角度地布置(包括0°，即电极主体110沿导管200之径向延伸)，只要满足弯曲形态时，电极主体110的两面分别朝向近端和远端即可。In some other embodiments, in the contracted state, the electrode body 110 is not limited to be perpendicular to the radial direction of the catheter 200, and the electrode body 110 and the catheter 200 may also be arranged at an angle (including 0°, that is, the electrode body 110 is arranged along the catheter 200 radial extension), as long as the two sides of the electrode main body 110 face the proximal end and the distal end respectively when the bending shape is satisfied.

进一步的，所述电极主体110处于所述弯曲形态时，所述近端子电极组件中的电极120与所述远端子电极组件中的电极120错位分布或并排设置，以增加电极组件100用于消融的面积，也可以使消融的能量分布集中。Further, when the electrode main body 110 is in the bent shape, the electrodes 120 in the proximal terminal electrode assembly and the electrodes 120 in the distal terminal electrode assembly are distributed or arranged side by side, so as to increase the use of the electrode assembly 100 for ablation. The area of the ablation can also concentrate the energy distribution of the ablation.

进一步的，所述子电极组件中，至少一部分电极120的径向尺寸非一致。也可理解为，至少一部分所述电极120的横截面的面积不一致。位于所述近端部111的中部的所述电极120的径向尺寸比位于所述近端部111的两端的所述电极120的径向尺寸大，和/或，位于所述远端部113的中部的电极120的径向尺寸比位于所述远端部113的两端的电极120的径向尺大。具体地，请参照图3和图4，以近端部111和远端部113呈弧形为例，位于近端部111/远端部113的中间部分的电极120的径向尺寸较大，然后朝向近端部111/远端部113的两端，所述电极120的径向尺寸逐渐减小，因电极主体110处弯曲形态时，近端部111的中间部分和远端部113的中间部分之间的间距较大，可排布径向尺寸较大的所述电极120，朝向两端的部分二者之间的间距较小，可排布径向尺寸较小的所述电极120。如此，可优化所述电极120的排布方式，尽量利用冗余空间，增加电极组件100用于消融的面积，也可以使消融的能量分布集中。Further, in the sub-electrode assembly, at least a part of the electrodes 120 have non-uniform radial dimensions. It can also be understood that the cross-sectional areas of at least a part of the electrodes 120 are inconsistent. The radial dimension of the electrodes 120 located in the middle of the proximal portion 111 is larger than the radial dimension of the electrodes 120 located at both ends of the proximal portion 111 , and/or, located in the distal portion 113 The radial size of the electrodes 120 in the middle part is larger than the radial dimensions of the electrodes 120 at both ends of the distal part 113 . Specifically, please refer to FIG. 3 and FIG. 4 , taking the proximal portion 111 and the distal portion 113 as an example of an arc, the electrode 120 located in the middle of the proximal portion 111/distal portion 113 has a larger radial dimension, Then toward the two ends of the proximal end portion 111/the distal end portion 113, the radial dimension of the electrode 120 gradually decreases, because when the electrode body 110 is in a curved shape, the middle portion of the proximal end portion 111 and the middle portion of the distal end portion 113 The distance between the parts is larger, and the electrodes 120 with a larger radial dimension can be arranged, and the distance between the two parts towards both ends is smaller, and the electrodes 120 with a smaller radial dimension can be arranged. In this way, the arrangement of the electrodes 120 can be optimized, the redundant space can be utilized as much as possible, the area of the electrode assembly 100 used for ablation can be increased, and the energy distribution of ablation can also be concentrated.

当近端部111和远端部113中的一个呈弧形，另一个呈直线形，电极主体110处于弯曲形态时，近端部111和远端部113整体大致上呈现半椭圆形(包括半圆形)，当弧形的曲率接近椭圆弧时，此时所述的半椭圆形分别关于其长轴或短轴对称，便可配置近端部111和远端部113的电极120的径向尺寸分别从各自的中部向两端逐渐减小(递减)；同理，当近端部111和远端部113均呈弧形时，且两者的弧形的曲率都接近椭圆弧，弯曲形态时，近端部111和远端部113整体上呈现椭圆形(包括圆形)，也可配置近端部111和远端部113的电极120的径向尺寸分别从各自的中部向两端逐渐减小(递减)。需说明的是，上述的“椭圆形”以及“半椭圆形”中，近端部111和远端部113沿短轴相对(大致上是相对的，也可能是存在些许偏差，这里均理解为相对)的两个所述电极120的径向尺寸可以相等，也可不等，本实施例对此不限，此外，上述的“椭圆形”以及“半椭圆形”仅用于举例说明，而不对本发明有任何限制。When one of the proximal portion 111 and the distal portion 113 is arc-shaped and the other is linear, and the electrode main body 110 is in a curved configuration, the proximal portion 111 and the distal portion 113 generally present a semi-elliptical shape (including a semi-elliptical shape) as a whole. circle), when the curvature of the arc is close to an elliptical arc, the semi-ellipse is symmetrical about its major axis or minor axis respectively, and the radial direction of the electrodes 120 of the proximal portion 111 and the distal portion 113 can be configured. The size gradually decreases (decreases) from the respective middle part to both ends; similarly, when the proximal part 111 and the distal part 113 are arc-shaped, and the curvature of both arcs is close to an elliptical arc, the curved shape , the proximal portion 111 and the distal portion 113 are generally elliptical (including circular), and the radial dimensions of the electrodes 120 of the proximal portion 111 and the distal portion 113 can also be arranged gradually from the middle to both ends respectively. Decrease (decrease). It should be noted that, in the above-mentioned “ellipse” and “semi-ellipse”, the proximal end portion 111 and the distal end portion 113 are opposite along the short axis (approximately opposite, there may also be some deviations, which are all understood here as The radial dimensions of the two opposite electrodes 120 may be equal or unequal, which is not limited in this embodiment. In addition, the above-mentioned "ellipse" and "semi-ellipse" are only for illustration and not There are no limitations on the invention.

如图5所示，图5是图4的俯视图。所述电极主体110处于弯曲形态时，所述子电极组件中的标测电极123与所述导管200的轴线的最小距离介于5mm-20mm之间，即以导管200的轴线为中心，以R为半径所限定的空间，通过设置径向距离R，可改善标测电极123与组织的贴靠程度，提高标测的可靠性。应当理解的是，所述电极主体110的形态发生变化时，所述标测电极123的位置也将发生变化，故所述标测电极123与所述导管200的轴线的最小距离也会发生变化，但是需保证至少在所述标测电极123用于标测时，所述标测电极123与所述导管200的轴线的最小距离介于5mm-20mm之间。As shown in FIG. 5 , FIG. 5 is a top view of FIG. 4 . When the electrode main body 110 is in a curved shape, the minimum distance between the mapping electrode 123 in the sub-electrode assembly and the axis of the catheter 200 is between 5 mm and 20 mm, that is, the axis of the catheter 200 is the center, and R For the space defined by the radius, by setting the radial distance R, the degree of closeness between the mapping electrode 123 and the tissue can be improved, and the reliability of the mapping can be improved. It should be understood that when the shape of the electrode body 110 changes, the position of the mapping electrode 123 will also change, so the minimum distance between the mapping electrode 123 and the axis of the catheter 200 will also change. , but it must be ensured that at least when the mapping electrode 123 is used for mapping, the minimum distance between the mapping electrode 123 and the axis of the catheter 200 is between 5mm-20mm.

请参照图7，图7是本发明实施例提供的电极组件处于中间形态时的示意图，本实施例中，电极主体110还处于一中间形态，具体地，所述电极主体110在所述收缩形态和中间形态、以及所述中间形态和所述弯曲形态之间转换；所述电极主体110处于所述中间形态时，所述折叠部112于所述导管200上的投影(沿导管200的径向与导管200上的投影)，在所述近端部111和所述远端部113之间。可理解的，处于中间形态时，电极主体110和导管200所成结构的横截面大致上呈半椭圆形。实际地，可利用处于中间形态的电极主体110对生理管腔的管壁进行消融治疗。Please refer to FIG. 7. FIG. 7 is a schematic diagram of the electrode assembly provided by the embodiment of the present invention when it is in an intermediate state. In this embodiment, the electrode body 110 is still in an intermediate state. Specifically, the electrode body 110 is in the contracted state and the intermediate form, and between the intermediate form and the curved form; when the electrode body 110 is in the intermediate form, the projection of the folded portion 112 on the catheter 200 (along the radial direction of the catheter 200 and the projection on the catheter 200 ), between the proximal portion 111 and the distal portion 113 . It can be understood that, in the intermediate configuration, the cross-section of the structure formed by the electrode body 110 and the catheter 200 is roughly semi-elliptical. Actually, the electrode body 110 in the intermediate form can be used to perform ablation treatment on the wall of the physiological lumen.

可选的，所述电极主体110处于所述收缩形态和/或所述中间形态时，所述近端部111和所述远端部113沿所述导管200之横向错位排布。结合前文赘述，电极主体110处弯曲形态时，近端部111和远端部113沿导管200之横向错位排布，本实施例中电极主体110分别处于收缩形态、中间形态和弯曲形态时，近端部111和远端部113的排布情况包括以下若干种情况之一者：Optionally, when the electrode main body 110 is in the contracted form and/or the intermediate form, the proximal end portion 111 and the distal end portion 113 are dislocated along the transverse direction of the catheter 200 . Combined with the previous description, when the electrode body 110 is in a curved shape, the proximal end portion 111 and the distal end portion 113 are arranged in a dislocation along the lateral direction of the catheter 200. The arrangement of the end portion 111 and the distal end portion 113 includes one of the following several situations:

(1)在所述的收缩形态、中间形态和弯曲形态三种形态下，近端部111和远端部113均沿导管200之横向错位排布，其中，在收缩形态时，近端部111和远端部113贴靠于导管200上，电极主体110大致上呈卷曲状；(1) In the contracted form, the intermediate form and the curved form, the proximal end 111 and the distal end 113 are arranged in a lateral dislocation along the catheter 200, wherein, in the contracted form, the proximal end 111 and the distal end portion 113 are attached to the catheter 200, and the electrode body 110 is generally in a curled shape;

(2)电极主体110处于收缩形态和中间形态时，近端部111和远端部113非错位排布(比如二者可以是共导管200的轴线排布)，处于弯曲形态时，近端部111和远端部113错位；(2) When the electrode body 110 is in the contracted form and the intermediate form, the proximal part 111 and the distal part 113 are arranged in a non-displaced manner (for example, the two can be arranged on the same axis as the catheter 200), and when it is in the curved form, the proximal part 111 and the distal part 113 are misaligned;

(3)电极主体110处于收缩形态和中间形态中的一个时，近端部111和远端部113错位，处于收缩形态和中间形态的另一个时，近端部111和远端部113非错位，处于弯曲形态时，近端部111和远端部113错位。(3) When the electrode body 110 is in one of the contracted form and the intermediate form, the proximal part 111 and the distal part 113 are dislocated, and when it is in the other contracted form and the intermediate form, the proximal part 111 and the distal part 113 are not dislocated , in a bent configuration, the proximal portion 111 and the distal portion 113 are misaligned.

本实施例中，电极主体110处于上述三种形态时，近端部111和远端部113均沿导管200之横向错位排布。In this embodiment, when the electrode main body 110 is in the above three forms, the proximal end portion 111 and the distal end portion 113 are arranged in a dislocation along the lateral direction of the catheter 200 .

基于上述的电极组件100，结合图1-图5，本发明还提供一种电生理导管，其包括如上所述的导管200及如上所述的电极组件100，所述电极组件100的电极主体110的近端部111和远端部113中的至少一者可活动地与所述导管200连接，且所述近端部111及所述远端部113的至少一者上设置有子电极组件，所述近端部111及远端部113能够沿所述导管200相对移动并在所述折叠部112处对折，以使所述电极主体110在收缩形态和弯曲形态之间转换。Based on the above-mentioned electrode assembly 100, with reference to FIGS. 1-5, the present invention also provides an electrophysiological catheter, which includes the above-mentioned catheter 200 and the above-mentioned electrode assembly 100, the electrode body 110 of the electrode assembly 100 At least one of the proximal portion 111 and the distal portion 113 of the catheter 200 is movably connected, and at least one of the proximal portion 111 and the distal portion 113 is provided with a sub-electrode assembly, The proximal portion 111 and the distal portion 113 can move relatively along the catheter 200 and fold in half at the folded portion 112 , so that the electrode body 110 can switch between a contracted configuration and a curved configuration.

进一步，所述电生理导管包括多个所述电极组件100，且多个所述电极组件100沿所述导管200的周向排布，优选的，多个所述电极组件100沿所述导管200的周向均匀排布，以优化排布方式，使消融的能量分布均匀。请参照图4，多个电极组件100的电极主体110处于弯曲形态后，整体大致类似花瓣，与肺静脉口贴合(肺静脉口大致呈锥形)，进行消融以及采集生理信号。Further, the electrophysiological catheter includes a plurality of electrode assemblies 100, and a plurality of electrode assemblies 100 are arranged along the circumference of the catheter 200, preferably, a plurality of electrode assemblies 100 are arranged along the catheter 200 The circumferential direction is evenly arranged, and the arrangement method is optimized to make the ablation energy evenly distributed. Please refer to FIG. 4 , the electrode bodies 110 of the multiple electrode assemblies 100 are in a curved shape, generally similar to flower petals, and fit to the pulmonary vein ostium (the pulmonary vein ostium is approximately tapered) for ablation and collection of physiological signals.

更进一步的，所述电极组件100的电极主体110处于所述收缩形态时，相邻的两个所述电极组件100上的子电极组件沿所述导管200的轴向错位排布。可理解为，对于相邻的两个电极组件100，处于收缩形态时，其中一个电极组件100上的电极120与另一个电极组件100中的电极120错位排布。如此，可节省冗余空间，使导管200上排布的电极组件100数量足够多，提升消融深度，形成更广的消融灶。Furthermore, when the electrode body 110 of the electrode assembly 100 is in the contracted state, the sub-electrode assemblies on two adjacent electrode assemblies 100 are arranged in a dislocation along the axial direction of the catheter 200 . It can be understood that, when two adjacent electrode assemblies 100 are in the contracted state, the electrodes 120 on one of the electrode assemblies 100 and the electrodes 120 on the other electrode assembly 100 are misaligned. In this way, redundant space can be saved, the number of electrode assemblies 100 arranged on the catheter 200 can be sufficient, the ablation depth can be increased, and a wider ablation lesion can be formed.

更进一步的，所述电极组件100至少包括相邻的第一电极组件和第二电极组件，所述第一电极组件至少包括与所述第二电极组件的至少一部分电极的极性相反的电极。Furthermore, the electrode assembly 100 includes at least a first electrode assembly and a second electrode assembly adjacent to each other, and the first electrode assembly includes at least an electrode opposite in polarity to at least a part of the electrodes of the second electrode assembly.

例如，同一电极组件100上的近端子电极组件及远端子电极组件同时放电时，所述近端子电极组件和所述远端子电极组件的极性相同，相邻两个第一电极组件和第二电极组件上的子电极组件的极性相反；For example, when the proximal electrode assembly and the distal electrode assembly on the same electrode assembly 100 discharge at the same time, the polarity of the proximal electrode assembly and the distal electrode assembly are the same, and the two adjacent first electrode assemblies and the second electrode assemblies have the same polarity. The polarity of the sub-electrode assemblies on the electrode assembly is opposite;

所有电极组件100上的远端子电极组件同时放电且近端子电极组件不放电时，相邻两个第一电极组件和第二电极组件上的远端子电极组件的极性相反；When the distal terminal electrode assemblies on all electrode assemblies 100 are discharged simultaneously and the proximal terminal electrode assemblies are not discharged, the polarities of the distal terminal electrode assemblies on two adjacent first electrode assemblies and second electrode assemblies are opposite;

所有电极组件100上的近端子电极组件同时放电且远端子电极组件不放电时，相邻两个第一电极组件和第二电极组件上的近端子电极组件的极性相反。When the near-terminal electrode assemblies on all electrode assemblies 100 discharge simultaneously and the far-terminal electrode assemblies do not discharge, the polarities of the near-terminal electrode assemblies on the two adjacent first and second electrode assemblies are opposite.

请继续参照图4，所述导管200包括外管210和内管220，内管220可活动地穿设在外管210中(可理解为导管200具有伸缩性)，且内管220朝向远端伸出外管210。所述近端部111和所述远端部113中的至少一者用于可活动地与所述导管200连接，近端部111和远端部113沿所述导管200的相对移动(相对距离发生变化)，具体包括以下若干种情况之一者：Please continue to refer to FIG. 4, the catheter 200 includes an outer tube 210 and an inner tube 220, the inner tube 220 is movably threaded in the outer tube 210 (it can be understood that the catheter 200 has stretchability), and the inner tube 220 extends toward the distal end. Exit the outer tube 210 . At least one of the proximal portion 111 and the distal portion 113 is used to be movably connected to the catheter 200, and the relative movement of the proximal portion 111 and the distal portion 113 along the catheter 200 (relative distance change), specifically including one of the following situations:

(1)近端部111和远端部113同时可移动地设置于外管210上或内管220上，通过近端部111和远端部113移动后相对距离的变化，从而实现电极主体110的形态变化；(1) The proximal part 111 and the distal part 113 are movably arranged on the outer tube 210 or the inner tube 220 at the same time, and the change of the relative distance after the proximal part 111 and the distal part 113 move, thereby realizing the electrode body 110 change in shape;

(2)近端部111和远端部113中的一个固定于导管200上，另一个可移动地设置于导管200上，譬如，近端部111和远端部113中的一个固定于内管220上，另一个可移动地设置于内管220上，或者，近端部111和远端部113中的一个固定在外管210上，另一个可移动地设置于外管210上；(2) One of the proximal portion 111 and the distal portion 113 is fixed on the catheter 200, and the other is movably arranged on the catheter 200, for example, one of the proximal portion 111 and the distal portion 113 is fixed on the inner tube 220, the other is movably arranged on the inner tube 220, or one of the proximal part 111 and the distal part 113 is fixed on the outer tube 210, and the other is movably arranged on the outer tube 210;

(3)锁定外管210和内管220的位置，使二者不发生相对滑动，近端部111可移动地设置于外管210上，和/或，远端部113可移动地设置于内管220上，也可实现电极主体110的形态变化；(3) Lock the positions of the outer tube 210 and the inner tube 220 so that the two do not slide relative to each other, the proximal part 111 is movably arranged on the outer tube 210, and/or the distal part 113 is movably arranged on the inner tube On the tube 220, the shape change of the electrode body 110 can also be realized;

(4)近端部111固定于外管210上，远端部113固定于内管220上，通过内管220于外管210中的穿设移动(内管220向远端推送，以及内管220向近端回撤)，实现近端部111和远端部113之间的相对移动。(4) The proximal part 111 is fixed on the outer tube 210, the distal part 113 is fixed on the inner tube 220, and the inner tube 220 moves through the outer tube 210 (the inner tube 220 is pushed to the far end, and the inner tube 220 retracts toward the proximal end) to realize the relative movement between the proximal end portion 111 and the distal end portion 113.

上述中的(1)、(2)和(3)，可分别在近端部111和/或远端部113连接一牵引丝，以引导二者发生相对移动。In (1), (2) and (3) above, a pulling wire can be connected to the proximal part 111 and/or the distal part 113 respectively, so as to guide the relative movement of the two.

本实施例中，请继续参照图2及图7，所述电生理导管还包括近端安装部150和远端安装部160，所述电极组件100的近端部111通过所述近端安装部150安装在所述外管210上，所述电极组件100的远端部113通过所述远端安装部160安装在所述内管220上。收缩形态时，所述近端安装部150和远端安装部160大致上共线排布或者接近共线，便于技术人员方便安装。优选的，所述近端安装部150、所述远端安装部160和所述折叠部112的中心位于同一轴线(即导管200之轴线)上，所述近端部111和所述远端部113分别位于该轴线之两侧。In this embodiment, please continue to refer to FIG. 2 and FIG. 7, the electrophysiological catheter also includes a proximal installation part 150 and a distal installation part 160, and the proximal part 111 of the electrode assembly 100 passes through the proximal installation part. 150 is mounted on the outer tube 210 , and the distal end 113 of the electrode assembly 100 is mounted on the inner tube 220 through the distal mounting portion 160 . In the contracted state, the proximal mounting portion 150 and the distal mounting portion 160 are arranged substantially collinear or close to collinear, which is convenient for technicians to install. Preferably, the centers of the proximal mounting portion 150, the distal mounting portion 160 and the folding portion 112 are located on the same axis (ie, the axis of the catheter 200), and the proximal portion 111 and the distal portion 113 are respectively located on both sides of the axis.

基于上述的电生理导管，本实施例还提供一种电生理***，所述电生理***包括如上所述的电生理导管。需理解的，由于所述的电生理***包括所述的电生理导管，故所述的电生理***也具有所述的电生理导管所带来的有益效果。这里对电生理***工作原理及其他组成部分不做详细地阐述。Based on the above-mentioned electrophysiological catheter, this embodiment also provides an electrophysiological system, which includes the above-mentioned electrophysiological catheter. It should be understood that since the electrophysiological system includes the electrophysiological catheter, the electrophysiological system also has the beneficial effects brought by the electrophysiological catheter. The working principle and other components of the electrophysiological system will not be elaborated here.

进一步的，所述电生理***还包括能量源及控制单元，所述电生理导管的标测电极用于检测所述电生理导管的电极组件的位置信息，并将所述位置信息传输给所述控制单元，所述控制单元根据所述位置信息判断所述电极组件是否处于预定部位，若所述电极组件处于预定部位，则所述控制单元控制所述能量源向所述电极组件的子电极组件传输能量。其中，位置信息的确定，可以通过心脏各部位的不同电活动信号特征来确定，例如肺静脉信号。通过导管上的标测线路来采集所在部位的电信号，通过不同部位特有的电信号特征来判断是否到达预定治疗部位。本实施例中，所述控制单元例如是PLC，本申请对此不作任何限制。Further, the electrophysiological system further includes an energy source and a control unit, the mapping electrode of the electrophysiological catheter is used to detect the position information of the electrode assembly of the electrophysiological catheter, and transmit the position information to the A control unit, the control unit judges whether the electrode assembly is at a predetermined position according to the position information, and if the electrode assembly is at a predetermined position, the control unit controls the energy source to the sub-electrode assembly of the electrode assembly transfer energy. Wherein, the location information can be determined through different electrical activity signal characteristics of various parts of the heart, such as pulmonary vein signals. The electrical signal of the site is collected through the mapping circuit on the catheter, and the specific electrical signal characteristics of different parts are used to judge whether it has reached the predetermined treatment site. In this embodiment, the control unit is, for example, a PLC, which is not limited in this application.

综上所述，本发明实施例提供了一种电极组件、电生理导管及电生理***，所述电极组件能够设置于一导管的远端，并用于在设备(如，能量源)和预定部位之间传输能量，所述电极组件包括电极主体及布置于所述电极主体上的子电极组件和电传输线路，所述电传输线路包括若干消融线路，所述子电极组件包括若干第一消融电极及若干第二消融电极，所述消融线路包括传输主路、第一传输支路及第二传输支路，所述第一消融电极和所述第二消融电极分别与对应的所述第一传输支路的输出端和所述第二传输支路的输出端电连接，所述第一传输支路的输入端与所述第二传输支路的输入端交汇于所述传输主路。通过将不同消融电极的传输支路并线设置，降低了消融线路的阻值，提高了消融线路的耐电流能力，同时还改善了导管的消融边界，提高了消融深度。In summary, embodiments of the present invention provide an electrode assembly, an electrophysiological catheter, and an electrophysiological system. The electrode assembly includes an electrode body and a sub-electrode assembly arranged on the electrode body and an electrical transmission line, the electrical transmission line includes a number of ablation lines, and the sub-electrode assembly includes a number of first ablation electrodes and a plurality of second ablation electrodes, the ablation circuit includes a transmission main circuit, a first transmission branch and a second transmission branch, the first ablation electrodes and the second ablation electrodes are respectively connected to the corresponding first transmission The output end of the branch is electrically connected to the output end of the second transmission branch, and the input end of the first transmission branch and the input end of the second transmission branch meet at the main transmission road. By arranging the transmission branches of different ablation electrodes in parallel, the resistance value of the ablation line is reduced, the current resistance capability of the ablation line is improved, and the ablation boundary of the catheter is improved, and the ablation depth is increased.

上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员如上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。The above description is only a description of the preferred embodiments of the present invention, not any limitation to the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention as disclosed above shall fall within the protection scope of the claims.

Claims

一种电极组件，能够设置于一导管的远端，并用于在一设备和预定部位之间传输能量，其特征在于，所述电极组件包括电极主体及布置于所述电极主体上的子电极组件和电传输线路，所述电传输线路包括若干消融线路，所述子电极组件包括若干第一消融电极及若干第二消融电极，所述消融线路包括传输主路、第一传输支路及第二传输支路，所述第一消融电极和所述第二消融电极分别与对应的所述第一传输支路的输出端和所述第二传输支路的输出端电连接，所述第一传输支路的输入端与所述第二传输支路的输入端交汇于所述传输主路。An electrode assembly, which can be arranged at the distal end of a catheter, and is used to transmit energy between a device and a predetermined site, is characterized in that the electrode assembly includes an electrode body and a sub-electrode assembly arranged on the electrode body and an electrical transmission line, the electrical transmission line includes a number of ablation lines, the sub-electrode assembly includes a number of first ablation electrodes and a number of second ablation electrodes, and the ablation line includes a main transmission line, a first transmission branch, and a second A transmission branch, the first ablation electrode and the second ablation electrode are respectively electrically connected to the corresponding output end of the first transmission branch and the output end of the second transmission branch, and the first transmission The input end of the branch and the input end of the second transmission branch meet at the main transmission road.
如权利要求1所述的电极组件，其特征在于，所述子电极组件还包括若干标测电极，所述电传输线路还包括布置于所述电极主体上的若干标测线路，所述标测电极与所述标测线路一一对应并电连接。The electrode assembly according to claim 1, wherein the sub-electrode assembly further includes several mapping electrodes, and the electrical transmission line also includes several mapping lines arranged on the electrode body, and the mapping electrodes The electrodes are in one-to-one correspondence with the mapping lines and are electrically connected.
如权利要求2所述的电极组件，其特征在于，所述标测电极包括第一标测电极和第二标测电极，所述标测线路包括相互绝缘的第一标测线路和第二标测线路，所述第一标测电极和所述第二标测电极分别与所述第一标测线路和所述第二标测线路电连接。The electrode assembly according to claim 2, wherein the mapping electrodes include a first mapping electrode and a second mapping electrode, and the mapping lines include a first mapping line and a second mapping line insulated from each other. The first mapping electrode and the second mapping electrode are electrically connected to the first mapping line and the second mapping line, respectively.
如权利要求2所述的电极组件，其特征在于，至少一条所述标测线路的宽度介于0.02mm-0.5mm之间。The electrode assembly according to claim 2, wherein at least one of said mapping lines has a width between 0.02mm-0.5mm.
如权利要求2所述的电极组件，其特征在于，至少在所述标测电极用于标测时，所述标测电极与所述导管的轴线的最小距离介于5mm-20mm之间。The electrode assembly according to claim 2, wherein at least when the mapping electrode is used for mapping, the minimum distance between the mapping electrode and the axis of the catheter is between 5mm-20mm.
如权利要求1-5中的任一项所述的电极组件，其特征在于，所述子电极组件中的电极和/或所述电传输线路均沿所述电极主体的延伸方向设置。The electrode assembly according to any one of claims 1-5, characterized in that, the electrodes in the sub-electrode assembly and/or the electrical transmission lines are all arranged along the extending direction of the electrode body.
如权利要求6所述的电极组件，其特征在于，所述子电极组件中的电极沿所述电极主体的延伸方向等间距分布。The electrode assembly according to claim 6, wherein the electrodes in the sub-electrode assembly are equally spaced along the extension direction of the electrode body.
如权利要求7所述的电极组件，其特征在于，相邻两个所述电极之间的间距小于10mm。The electrode assembly according to claim 7, wherein the distance between two adjacent electrodes is less than 10mm.
如权利要求1所述的电极组件，其特征在于，至少一条所述传输主路的宽度介于0.04mm-1mm之间。The electrode assembly according to claim 1, wherein the width of at least one main transmission path is between 0.04mm-1mm.
如权利要求1或9所述的电极组件，其特征在于，所述第一传输支路及所述第二传输支路中的至少一者的宽度介于0.02mm-0.5mm之间。The electrode assembly according to claim 1 or 9, wherein at least one of the first transmission branch and the second transmission branch has a width between 0.02mm-0.5mm.
如权利要求1-10中的任一项所述的电极组件，其特征在于，所述电极主体包括沿所述导管的轴向由近端至远端的近端部、折叠部及远端部，所述近端部及所述远端部的至少一者上设置有所述子电极组件，所述近端部和所述远端部中的至少一者可活动地与所述导管连接，所述近端部及远端部能够沿所述导管相对移动并在所述折叠部处对折，以使所述电极主体在收缩形态和弯曲形态之间转换；The electrode assembly according to any one of claims 1-10, wherein the electrode body comprises a proximal portion, a folding portion and a distal portion along the axial direction of the catheter from the proximal end to the distal end , at least one of the proximal portion and the distal portion is provided with the sub-electrode assembly, and at least one of the proximal portion and the distal portion is movably connected to the catheter, The proximal portion and the distal portion can move relatively along the catheter and fold in half at the folding portion, so that the electrode body can be converted between a contracted configuration and a curved configuration;

所述电极主体处于所述收缩形态时，所述电极主体沿所述导管的径向向所述导管收拢；所述电极主体处于所述弯曲形态时，所述电极主体沿所述导管的径向向外扩张，以使所述近端部与所述远端部在所述折叠部处对折，形成沿所述导管之横向的错位排布。When the electrode body is in the contracted shape, the electrode body is drawn toward the catheter along the radial direction of the catheter; expanding outward, so that the proximal part and the distal part are folded in half at the folding part to form a dislocation arrangement along the lateral direction of the catheter.
如权利要求11所述的电极组件，其特征在于，所述近端部及所述远端部上均设置有所述子电极组件，所述子电极组件包括设置在所述近端部的近端子电极组件及设置在所述远端的远端子电极组件，所述电极主体包括相对的内侧面及外侧面，所述内侧面为所述电极主体面向于所述导管的表面，所述外侧面为所述电极主体背离所述导管的表面：The electrode assembly according to claim 11, characterized in that, the sub-electrode assembly is provided on the proximal part and the distal part, and the sub-electrode assembly includes a proximal part arranged on the proximal part. The terminal electrode assembly and the distal electrode assembly disposed at the distal end, the electrode body includes an opposite inner surface and an outer surface, the inner surface is the surface of the electrode body facing the catheter, and the outer surface For the surface of the electrode body facing away from the catheter:

所述近端子电极组件及所述远端子电极组件均位于所述内侧面上；或者，Both the proximal terminal electrode assembly and the distal terminal electrode assembly are located on the inner side; or,

所述近端子电极组件及所述远端子电极组件均位于所述外侧面上；或者，Both the proximal terminal electrode assembly and the distal terminal electrode assembly are located on the outer side; or,

所述近端子电极组件位于所述内侧面上，所述远端子电极组件位于所述外侧面上；或者，The proximal terminal electrode assembly is located on the inner side and the distal terminal electrode assembly is located on the outer side; or,

所述近端子电极组件位于所述外侧面上，所述远端子电极组件位于所述内侧面上。The proximal terminal electrode assembly is located on the outer side, and the distal terminal electrode assembly is located on the inner side.
如权利要求12所述的电极组件，其特征在于，所述电极主体处于所述弯曲形态时，所述近端子电极组件中的电极与所述远端子电极组件中的电极错位分布或并排设置。The electrode assembly according to claim 12, wherein when the electrode main body is in the bent shape, the electrodes in the proximal terminal electrode assembly and the electrodes in the distal terminal electrode assembly are distributed in a dislocation or arranged side by side.
如权利要求12所述的电极组件，其特征在于，所述折叠部具有凹槽，以使所述电极主体处于所述弯曲形态时，所述远端子电极组件和所述近端子电极组件位于同一平面上。The electrode assembly according to claim 12, wherein the folded portion has a groove, so that when the electrode body is in the bent configuration, the distal terminal electrode assembly and the proximal terminal electrode assembly are located at the same on flat surface.
一种电生理导管，其特征在于，包括如权利要求1-14中的任一项所述的电极组件及一导管。An electrophysiological catheter, characterized by comprising the electrode assembly according to any one of claims 1-14 and a catheter.
如权利要求15所述的电生理导管，其特征在于，所述电生理导管包括多个所述电极组件，且多个所述电极组件沿所述导管的周向排布。The electrophysiological catheter according to claim 15, wherein the electrophysiological catheter comprises a plurality of electrode assemblies, and the plurality of electrode assemblies are arranged along the circumference of the catheter.
如权利要求16所述的电生理导管，其特征在于，所述电极组件至少包括相邻的第一电极组件和第二电极组件，所述第一电极组件至少包括与所述第二电极组件的至少一部分电极的极性相反的电极。The electrophysiological catheter according to claim 16, wherein the electrode assembly includes at least a first electrode assembly and a second electrode assembly adjacent to each other, and the first electrode assembly includes at least an electrode assembly adjacent to the second electrode assembly. At least a portion of the electrodes are electrodes of opposite polarity.
一种电生理***，其特征在于，包括如权利要求15-17中的任一项所述的电生理导管。An electrophysiological system, characterized by comprising the electrophysiological catheter according to any one of claims 15-17.
如权利要求18所述的电生理***，其特征在于，所述电生理***还包括能量源及控制单元，所述电生理导管的标测电极用于检测所述电生理导管的电极组件的位置信息，并将所述位置信息传输给所述控制单元，所述控制单元根据所述位置信息判断所述电极组件是否处于预定部位，若所述电极组件处于预定部位，则所述控制单元控制所述能量源向所述电极组件传输能量。The electrophysiological system according to claim 18, wherein the electrophysiological system further comprises an energy source and a control unit, and the mapping electrode of the electrophysiological catheter is used to detect the position of the electrode assembly of the electrophysiological catheter information, and transmit the position information to the control unit, and the control unit judges whether the electrode assembly is at a predetermined position according to the position information, and if the electrode assembly is at a predetermined position, the control unit controls the The energy source transmits energy to the electrode assembly.