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CN115444542A - Left atrial appendage blockage ablation device - Google Patents

Left atrial appendage blockage ablation device Download PDF

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Publication number
CN115444542A
CN115444542A CN202110790616.3A CN202110790616A CN115444542A CN 115444542 A CN115444542 A CN 115444542A CN 202110790616 A CN202110790616 A CN 202110790616A CN 115444542 A CN115444542 A CN 115444542A
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atrial appendage
conductive
left atrial
connector
ablation device
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李建民
尤岩
吴能标
王坤
王永胜
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Hangzhou Dinova EP Technology Co Ltd
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Hangzhou Dinova EP Technology Co Ltd
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Priority to PCT/CN2022/097720 priority Critical patent/WO2022257992A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01RELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
    • H01R13/00Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
    • H01R13/02Contact members
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01RELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
    • H01R13/00Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
    • H01R13/40Securing contact members in or to a base or case; Insulating of contact members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00613Irreversible electroporation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/0063Sealing

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Abstract

The invention relates to a left atrial appendage occlusion ablation device. Left atrial appendage shutoff ablation device includes: the anchoring disc is of a radial telescopic support structure; the sealing disc is of a radial telescopic support structure and is arranged at the near end of the anchoring disc; the sealing disc is made of a conductive material, and the whole sealing disc is used as a first conductive part for transmitting ablation energy or collecting tissue physiological signals. The anchoring disc is released in the left auricle, the anchoring disc can anchor the inner wall of the tissue of the left auricle, and the sealing disc is released at the entrance of the left auricle, so that the sealing disc blocks the entrance of the left auricle, blocks thrombus in the left auricle and effectively prevents the thrombus from entering the left atrium. Simultaneously the whole electrically conductive and transmission of sealed dish melts the energy, melts left auricle portion, more is favorable to melting the area at the complete ring-shaped of oral area formation, and then is convenient for thoroughly keep apart left auricle and left atrium electricity at left auricle portion, greatly improves and melts the effect.

Description

左心耳封堵消融装置Left atrial appendage blockage ablation device

技术领域technical field

本发明涉及介入医疗器械技术领域,特别涉及一种左心耳封堵消融装置。The invention relates to the technical field of interventional medical devices, in particular to a left atrial appendage blockage ablation device.

背景技术Background technique

心房颤动(简称房颤)是最常见的持续性心律失常,随着年龄的增长,房颤发生率不断增加,75岁以上人群可达10%。房颤患病率还与冠心病、高血压病和心力衰竭等疾病有密切关系。左心耳因其特殊形态及结构不仅为房颤血栓形成最主要的部位,也是其发生和维持的关键区域之一,部分房颤患者可经主动左心耳电隔离获益。Atrial fibrillation (abbreviated as atrial fibrillation) is the most common sustained arrhythmia, and with age, the incidence of atrial fibrillation continues to increase, reaching 10% in people over 75 years old. The prevalence of atrial fibrillation is also closely related to diseases such as coronary heart disease, hypertension and heart failure. Due to its special shape and structure, the left atrial appendage is not only the most important site for atrial fibrillation thrombosis, but also one of the key areas for its occurrence and maintenance. Some patients with atrial fibrillation can benefit from active left atrial appendage electrical isolation.

采用联合导管射频消融和左心耳封堵的一站式治疗方法,已经取得了很多成功治疗房颤的案例。目前,采用联合导管射频消融和左心耳封堵的一站式治疗方法,已经取得了很多成功治疗房颤的案例。一站式治疗方法中,通过左心耳封堵术,患者在不需终身服用抗凝药物的情况下仍能获得良好的卒中预防效果;再结合导管射频消融恢复并维持窦律进而改善房颤患者症状,可使患者获得稳定的远期治疗效果。然而,若要在上述一站式治疗的过程中对左心耳进行消融术和封堵术,需要以介入方式引入消融导管与左心耳封堵消融装置,关键是要将两个设备先后定位在左心耳口部位置,再分别实行消融与封堵,由于消融导管以及左心耳封堵在左心耳口部定位难度均较大,导致手术程序复杂,耗时长,不利于提高“消融+左心耳封堵”一站式治疗手术的便捷性。Many cases of atrial fibrillation have been successfully treated using the one-stop treatment method of combined catheter radiofrequency ablation and left atrial appendage occlusion. At present, many cases of atrial fibrillation have been successfully treated by using a one-stop treatment method combining catheter radiofrequency ablation and left atrial appendage closure. In the one-stop treatment method, through the closure of the left atrial appendage, patients can still obtain good stroke prevention effects without taking anticoagulant drugs for life; combined with catheter radiofrequency ablation to restore and maintain sinus rhythm and improve patients with atrial fibrillation Symptoms can enable patients to obtain stable long-term therapeutic effects. However, in order to perform ablation and closure of the left atrial appendage during the above-mentioned one-stop treatment, it is necessary to introduce an ablation catheter and a closure and ablation device for the left atrial appendage in an interventional manner. The key is to position the two devices successively on the left At the mouth of the atrial appendage, ablation and occlusion are performed separately. Since the ablation catheter and the occlusion of the left atrial appendage are difficult to locate at the mouth of the left atrial appendage, the surgical procedure is complicated and time-consuming, which is not conducive to improving the "ablation + left atrial appendage occlusion" "The convenience of one-stop treatment and surgery.

发明内容Contents of the invention

本发明的目的在于提供一种左心耳封堵消融装置,其能够有效改善现有技术中存在的“消融+左心耳封堵”一站式治疗手术程序复杂、难度大的技术问题。The purpose of the present invention is to provide a left atrial appendage occlusion ablation device, which can effectively improve the technical problem of "ablation + left atrial appendage occlusion" one-stop treatment operation procedure is complicated and difficult in the prior art.

为解决上述技术问题,本发明采用如下技术方案:In order to solve the problems of the technologies described above, the present invention adopts the following technical solutions:

本发明的实施例提供了一种左心耳封堵消融装置,该左心耳封堵消融装置包括:锚定盘,其为径向可伸缩的支架结构;以及密封盘,其为径向可伸缩的支架结构,并设于所述锚定盘的近端;所述密封盘由导电材料制成,且所述密封盘整体作为用于传输消融能量或采集组织生理信号的第一导电部。An embodiment of the present invention provides a left atrial appendage blockage ablation device, the left atrial appendage blockage ablation device includes: an anchoring disc, which is a radially expandable stent structure; and a sealing disc, which is radially expandable The stent structure is arranged at the proximal end of the anchoring disk; the sealing disk is made of conductive material, and the sealing disk as a whole serves as a first conductive part for transmitting ablation energy or collecting tissue physiological signals.

根据本申请一些实施例,所述左心耳封堵消融装置还包括第二导电部,所述第二导电部分别用于传输消融能量或采集组织生理信号;所述第二导电部设于所述锚定盘上;所述密封盘与所述第二导电部电隔离。According to some embodiments of the present application, the left atrial appendage blockage ablation device further includes a second conductive part, and the second conductive part is respectively used to transmit ablation energy or collect tissue physiological signals; the second conductive part is arranged on the on the anchor disk; the sealing disk is electrically isolated from the second conductive part.

由上述技术方案可知,本发明实施例至少具有如下优点和积极效果:It can be seen from the above technical solutions that the embodiments of the present invention have at least the following advantages and positive effects:

本发明的实施例提供的左心耳封堵消融装置,包括锚定盘和密封盘;锚定盘和密封盘均为径向可伸缩的支架结构,利用锚定盘在左心耳内释放,锚定盘可锚定左心耳的组织内壁,利用密封盘在左心耳入口处释放,可利用密封盘封堵左心耳入口处,封堵左心耳内部的血栓,有效地防止血栓进入左心房。同时密封盘整体导电并作为第一导电部并传输消融能量,对左心耳口部消融,更有利于在口部形成完整的环状消融带,进而便于在左心耳口部彻底将左心耳与左心房电隔离,极大地提高消融效果。密封盘作为第一导电部也可以用于采集组织生理信号,以进行标测。此外,该左心耳封堵消融装置将消融与封堵结合,简化了“消融+左心耳封堵”一站式治疗手术的程序,有助于降低手术难度。The left atrial appendage occlusion ablation device provided by the embodiment of the present invention includes an anchoring disc and a sealing disc; The disc can be anchored to the tissue inner wall of the left atrial appendage, released at the entrance of the left atrial appendage by using the sealing disc, and the sealing disc can be used to block the entrance of the left atrial appendage, block the thrombus inside the left atrial appendage, and effectively prevent the thrombus from entering the left atrium. At the same time, the sealing disk conducts electricity as a whole and acts as the first conductive part to transmit ablation energy. For the ablation of the mouth of the left atrial appendage, it is more conducive to forming a complete ring-shaped ablation zone at the mouth of the left atrial appendage. The electrical isolation of the atrium greatly improves the ablation effect. The sealing disc, as the first conductive part, can also be used to collect tissue physiological signals for mapping. In addition, the left atrial appendage occlusion ablation device combines ablation and occlusion, which simplifies the procedure of "ablation + left atrial appendage occlusion" one-stop treatment and helps reduce the difficulty of surgery.

附图说明Description of drawings

图1为本发明的实施例1提供的左心耳封堵消融装置的结构示意图。FIG. 1 is a schematic structural view of the left atrial appendage occlusion ablation device provided by Embodiment 1 of the present invention.

图2为本发明的实施例1提供的左心耳封堵消融装置的剖面结构示意图。Fig. 2 is a schematic cross-sectional structure diagram of the left atrial appendage occlusion ablation device provided by Embodiment 1 of the present invention.

图3为图2中Ⅲ处的局部结构放大示意图。Fig. 3 is an enlarged schematic diagram of the local structure at III in Fig. 2 .

图4为本发明的实施例1提供的输送器的结构示意图。Fig. 4 is a schematic structural diagram of the conveyor provided by Embodiment 1 of the present invention.

图5为图2中第一骨架的结构示意图。FIG. 5 is a schematic structural diagram of the first skeleton in FIG. 2 .

图6为本发明的实施例2提供的左心耳封堵消融装置中绝缘连接件处的结构示意图。FIG. 6 is a schematic structural view of the insulating connector in the left atrial appendage blockage ablation device provided by Embodiment 2 of the present invention.

图7为本发明的实施例3提供的左心耳封堵消融装置中绝缘连接件处的结构示意图。Fig. 7 is a schematic structural view of the insulating connector in the left atrial appendage blockage ablation device provided by Embodiment 3 of the present invention.

图8为本发明的实施例4提供的左心耳封堵消融装置中绝缘连接件处的结构示意图。Fig. 8 is a schematic structural view of the insulating connector in the left atrial appendage blockage ablation device provided by Embodiment 4 of the present invention.

图9为本发明的实施例5提供的左心耳封堵消融装置中绝缘连接件处的结构示意图。Fig. 9 is a schematic structural view of the insulating connector in the left atrial appendage blockage ablation device provided by Embodiment 5 of the present invention.

图10为图9中左心耳封堵消融装置的绝缘连接件拉伸以及扭转活动时的结构示意图。FIG. 10 is a schematic structural view of the insulated connector of the left atrial appendage occlusion ablation device in FIG. 9 when stretched and twisted.

图11为本发明的实施例6提供的左心耳封堵消融装置的结构示意图。Fig. 11 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided by Embodiment 6 of the present invention.

图12为图11的左心耳封堵消融装置去掉覆膜后的剖面结构示意图。FIG. 12 is a schematic cross-sectional structure diagram of the left atrial appendage occlusion ablation device in FIG. 11 after the film is removed.

图13为本发明的实施例7提供的左心耳封堵消融装置的结构示意图。Fig. 13 is a schematic structural view of the left atrial appendage occlusion ablation device provided by Embodiment 7 of the present invention.

图14为本发明的实施例8提供的左心耳封堵消融装置的结构示意图。Fig. 14 is a schematic structural view of the left atrial appendage occlusion ablation device provided by Embodiment 8 of the present invention.

图15为本发明的实施例9提供的左心耳封堵消融装置的结构示意图。Fig. 15 is a schematic structural diagram of the left atrial appendage blockage ablation device provided by Embodiment 9 of the present invention.

图16为图15的左心耳封堵消融装置去掉覆膜后的结构示意图。FIG. 16 is a schematic structural view of the left atrial appendage occlusion ablation device in FIG. 15 after the film is removed.

图17为本发明的实施例10提供的左心耳封堵消融装置的结构示意图。Fig. 17 is a schematic structural diagram of the left atrial appendage blockage ablation device provided by Embodiment 10 of the present invention.

图18为图17的左心耳封堵消融装置去掉覆膜后的结构示意图。FIG. 18 is a schematic structural view of the left atrial appendage occlusion ablation device in FIG. 17 after the film is removed.

图19为本发明的实施例11提供的左心耳封堵消融装置的结构示意图。Fig. 19 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 11 of the present invention.

图20为图19的左心耳封堵消融装置去掉覆膜后的结构示意图。FIG. 20 is a schematic structural view of the left atrial appendage occlusion ablation device in FIG. 19 after the film is removed.

图21为本发明的实施例12提供的左心耳封堵消融装置去掉覆膜后的结构示意图。Fig. 21 is a schematic structural view of the left atrial appendage occlusion ablation device provided by Embodiment 12 of the present invention after removing the covering film.

图22为图21的左心耳封堵消融装置中第一骨架的结构示意图。Fig. 22 is a schematic structural view of the first frame in the left atrial appendage blockage ablation device shown in Fig. 21 .

图23为本发明的实施例13提供的左心耳封堵消融装置的结构示意图。Fig. 23 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 13 of the present invention.

图24为本发明的实施例14提供的左心耳封堵消融装置的结构示意图。Fig. 24 is a schematic structural diagram of the left atrial appendage blockage ablation device provided by Embodiment 14 of the present invention.

图25为图24的左心耳封堵消融装置去掉覆膜后的结构示意图。FIG. 25 is a schematic structural view of the left atrial appendage occlusion ablation device in FIG. 24 after the film is removed.

图26为本发明的实施例15提供的左心耳封堵消融装置的结构示意图。Fig. 26 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 15 of the present invention.

图27为图26中活动件的结构示意图。Fig. 27 is a schematic structural diagram of the movable part in Fig. 26 .

图28为图26中活动件的第二种结构示意图。Fig. 28 is a schematic diagram of the second structure of the movable part in Fig. 26 .

图29为图26中活动件的第三种结构示意图。Fig. 29 is a schematic diagram of the third structure of the movable part in Fig. 26 .

图30为图26中活动件的第四种结构示意图。Fig. 30 is a schematic diagram of the fourth structure of the movable part in Fig. 26 .

图31为图26中活动件的第五种结构示意图。Fig. 31 is a schematic diagram of the fifth structure of the movable part in Fig. 26 .

图32为本发明的实施例16提供的左心耳封堵消融装置的结构示意图。Fig. 32 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 16 of the present invention.

图33为本发明的实施例17提供的左心耳封堵消融装置的结构示意图。Fig. 33 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 17 of the present invention.

图34为本发明的实施例18提供的左心耳封堵消融装置的结构示意图。Fig. 34 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 18 of the present invention.

附图说明:100、消融支架;110、锚定盘;111、第一骨架;112、支撑部;1121、支撑杆;1122、第一分支;1123、第二分支;1124、第一连接点;113、锚定部;1131、连接杆;1132、第三分支;1133、第四分支;1134、第二连接点;114、第二导电部;116、第一电极件;117、倒刺;118、连接环;119、远端连接件;120、密封盘;121、第二骨架;122、第一导电部;123、第二电极件;124、第二导电连接部;125、绝缘膜;126、阻流膜;127、盘面;128、盘底;129、腰部;130、绝缘连接件;131、第一连接件;1311、第一安装空间;132、第二连接件;1321、内套筒;1322、外套筒;1323、第二安装空间;133、第三连接件;1331、大管段;1332、小管段;134、第一导电连接部;135、第四连接件;140、输送器;141、第二导管;142、第一导管;143、外管;144、手柄;150、活动件;1501、收束部;1511、第一部;1512、第二部;1513、第三部;1521、第一支杆;1522、第二支杆;1523、第一连杆;1524、第二连杆;1525、第三连接点;153、管体;1531、轴心段;1532、外延段;1533、环形段;154、管电极;161、第一盘;162、第二盘;163、第三盘。Description of drawings: 100, ablation bracket; 110, anchoring plate; 111, first frame; 112, support part; 1121, support rod; 1122, first branch; 1123, second branch; 1124, first connection point; 113. Anchoring part; 1131. Connecting rod; 1132. Third branch; 1133. Fourth branch; 1134. Second connection point; 114. Second conductive part; 116. First electrode part; 117. Barb; 118 , connection ring; 119, distal connector; 120, sealing disc; 121, second skeleton; 122, first conductive part; 123, second electrode part; 124, second conductive connection part; 125, insulating film; 126 , choke film; 127, disk surface; 128, disk bottom; 129, waist; 130, insulating connector; 131, first connector; 1311, first installation space; 132, second connector; 1321, inner sleeve 1322, outer sleeve; 1323, second installation space; 133, third connector; 1331, large pipe section; 1332, small pipe section; 134, first conductive connection part; 135, fourth connector; 140, conveyor ; 141, the second catheter; 142, the first catheter; 143, the outer tube; 144, the handle; 150, the movable part; ; 1521, the first pole; 1522, the second pole; 1523, the first connecting rod; 1524, the second connecting rod; 1525, the third connecting point; 153, the pipe body; 1533, ring segment; 154, tube electrode; 161, first plate; 162, second plate; 163, third plate.

具体实施方式detailed description

体现本发明特征与优点的典型实施方式将在以下的说明中详细叙述。应理解的是本发明能够在不同的实施方式上具有各种的变化,其皆不脱离本发明的范围,且其中的说明及图示在本质上是当作说明之用,而非用以限制本发明。Typical embodiments that embody the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention is capable of various changes in different embodiments without departing from the scope of the present invention, and that the description and illustrations therein are illustrative in nature and not limiting. this invention.

在本申请的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本申请和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本申请的限制。In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Orientation indicated by rear, left, right, vertical, horizontal, top, bottom, inside, outside, clockwise, counterclockwise, etc. The positional relationship is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, Therefore, it should not be construed as limiting the application.

此外,术语“第一”、“第二”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”的特征可以明示或者隐含地包括一个或者更多个所述特征。在本申请的描述中,“多个”的含义是两个或两个以上,除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of said features. In the description of the present application, "plurality" means two or more, unless otherwise specifically defined.

在本申请的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本申请中的具体含义。In the description of this application, it should be noted that unless otherwise specified and limited, the terms "installation", "connection", and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations.

需要说明的是,在不冲突的情况下,本发明的实施例中的特征可以相互结合。It should be noted that, in the case of no conflict, the features in the embodiments of the present invention may be combined with each other.

定义释义:Definition Interpretation:

左心耳入口:从左心房进入左心耳的位置。Left atrial appendage entrance: The location where the left atrial appendage enters from the left atrium.

近端和远端:某部件植入后,相对靠近体外的一端为该部件的近端;某部件植入后,相对靠近体内的一端为该部件的远端。换言之,该左心耳封堵消融装置植入左心耳处后,左心耳封堵消融装置中某部件的近端为该部件靠近左心房的一端,某部件的远端为该部件靠近左心耳的一端。Proximal end and distal end: After a component is implanted, the end relatively close to the outside of the body is the proximal end of the component; after a certain component is implanted, the end relatively close to the body is the distal end of the component. In other words, after the LAA occlusion ablation device is implanted in the left atrial appendage, the proximal end of a certain component in the LAA occlusion ablation device is the end of the component close to the left atrium, and the distal end of a certain component is the end of the component close to the left atrial appendage .

绝缘处理:在某部件的表面形成绝缘层,从而使部件该部分绝缘。具体地,绝缘处理的方式有:在需进行绝缘处理的位置涂覆绝缘涂层材料,涂层材料包括但不限于派瑞林涂层、PTFE涂层、PI涂层;或者,在需进行绝缘处理的位置覆盖绝缘膜,膜材料包括但不限于FEP、PU、ETFE、PFA、PTFE、PEEK、硅胶;或者,在需进行绝缘处理的位置穿套绝缘套管,绝缘套管的材料包括但不限于FEP、PU、ETFE、PFA、PTFE、PEEK、硅胶。Insulation treatment: Forming an insulating layer on the surface of a component to insulate that part of the component. Specifically, the insulation treatment methods include: coating insulation coating materials at the position where insulation treatment is required, coating materials include but not limited to parylene coating, PTFE coating, PI coating; or, where insulation treatment is required The treated position is covered with an insulating film, and the film material includes but not limited to FEP, PU, ETFE, PFA, PTFE, PEEK, silica gel; or, an insulating sleeve is worn at the position that needs to be insulated, and the material of the insulating sleeve includes but not Limited to FEP, PU, ETFE, PFA, PTFE, PEEK, Silicone.

本发明实施例提供的左心耳封堵消融装置用于植入至左心耳口部,并能够对左心耳组织进行脉冲消融或者射频消融。脉冲消融利用高强度的脉冲电场使细胞膜发生不可逆电击穿,在医学领域称之为不可逆电穿孔(Irreversible electroporation,IRE),使细胞凋亡从而实现非热效应消融细胞,所以不受热沉效应影响。高电压脉冲序列产热少,不需要生理盐水冲洗来冷却,可有效减少气爆、焦痂和血栓的发生。脉冲消融治疗时间短,施加一组脉冲序列的治疗时间不到1分钟,全程消融时间一般不超过5分钟。且由于不同组织对脉冲电场的反应阈值存在差异,为消融心肌而不干扰其他临近组织提供了可能,从而可避免误伤左心耳临近的组织。另外,相较于其他能量,脉冲消融不需要热传导来对深层组织消融,所有分布在一定电场强度之上的心肌细胞均会发生电穿孔,降低了消融时对导管贴靠压力的要求。因此即使消融器械在进入左心耳内后没有完全地贴合左心耳内壁,也不影响IRE消融效果。施放脉冲能量的电极也可以采集心内电信号,在消融前,采集心内心电信号传递至心电同步仪,使脉冲输出同步在心肌收缩的绝对不应期,从而不干扰心率,减少突发心律失常;在消融操作后,也可通过心内信号判断是否对组织完全电隔离。The left atrial appendage occlusion ablation device provided by the embodiment of the present invention is used to be implanted in the ostium of the left atrial appendage, and can perform pulse ablation or radiofrequency ablation on the left atrial appendage tissue. Pulse ablation uses a high-intensity pulsed electric field to cause irreversible electrical breakdown of the cell membrane, which is called irreversible electroporation (IRE) in the medical field, and causes cell apoptosis to achieve non-thermal ablation of cells, so it is not affected by the heat sink effect. The high-voltage pulse sequence produces less heat and does not need saline irrigation for cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombus. The pulse ablation treatment time is short, the treatment time of applying a set of pulse sequences is less than 1 minute, and the whole ablation time is generally no more than 5 minutes. Moreover, since different tissues have different response thresholds to pulsed electric fields, it is possible to ablate the myocardium without disturbing other adjacent tissues, thereby avoiding accidentally injuring tissues adjacent to the left atrial appendage. In addition, compared with other energies, pulse ablation does not require heat conduction to ablate deep tissues, and all cardiomyocytes distributed above a certain electric field strength will undergo electroporation, which reduces the pressure requirements for catheter abutment during ablation. Therefore, even if the ablation instrument does not completely adhere to the inner wall of the left atrial appendage after entering the left atrial appendage, the ablation effect of the IRE will not be affected. Electrodes that release pulse energy can also collect intracardiac electrical signals. Before ablation, the collected intracardiac electrical signals are transmitted to the ECG synchronization instrument, so that the pulse output is synchronized in the absolute refractory period of myocardial contraction, so as not to interfere with the heart rate and reduce bursts. Cardiac arrhythmias; complete electrical isolation of tissue can also be judged by intracardiac signals after ablation procedures.

实施例1Example 1

图1为本实施例提供的左心耳封堵消融装置的结构示意图,图2为本实施例提供的左心耳封堵消融装置的剖面结构示意图,图2相较于图1去掉了阻流膜126,且图2中锚定盘110位于方框内的部分第一骨架111即形成第二导电部114,密封盘120的第二骨架121整体形成第一导电部122。Fig. 1 is a schematic structural view of the left atrial appendage occlusion ablation device provided in this embodiment, and Fig. 2 is a schematic cross-sectional structure diagram of the left atrial appendage occlusion ablation device provided in this embodiment, and Fig. 2 removes the flow blocking film 126 compared with Fig. 1 , and part of the first skeleton 111 of the anchoring disc 110 in FIG.

请结合参照图1和图2,本实施例提供的左心耳封堵消融装置,包括消融支架100,该消融支架100包括锚定盘110、密封盘120以及绝缘连接件130。Please refer to FIG. 1 and FIG. 2 . The left atrial appendage occlusion ablation device provided in this embodiment includes an ablation stent 100 , and the ablation stent 100 includes an anchoring disc 110 , a sealing disc 120 and an insulating connector 130 .

锚定盘110的第一骨架111和密封盘120的第二骨架121均为径向可伸缩的支架结构。例如,该支架结构可以是网格状或网管状的支架。该支架结构在外力压迫下,可以沿径向收缩在轴心处,以便于消融支架100整体进行保存或输送。在压迫力消失时,可以自然沿径向膨胀,恢复网格状或网管状的支架结构,以便于消融支架100整体能够固定在左心耳处。可以理解的是,该支架结构也可以是其他形状的径向可伸缩的支架结构。Both the first frame 111 of the anchoring disc 110 and the second frame 121 of the sealing disc 120 are radially stretchable support structures. For example, the stent structure may be a grid-like or mesh-like stent. Under the pressure of external force, the stent structure can be shrunk at the axial center in the radial direction, so as to facilitate the preservation or delivery of the ablation stent 100 as a whole. When the compressive force disappears, it can expand naturally in the radial direction to restore the grid-like or mesh-like stent structure, so that the ablation stent 100 can be fixed on the left atrial appendage as a whole. It can be understood that the stent structure may also be a radially expandable stent structure of other shapes.

一般地,第一骨架111和第二骨架121均由具有形状记忆和超弹性的金属材料制成,比如镍钛合金。具体地,可由金属丝编织制成,或由金属管材切割制成。Generally, both the first skeleton 111 and the second skeleton 121 are made of metal materials with shape memory and superelasticity, such as nickel-titanium alloy. Specifically, it can be made by weaving metal wires or cutting metal pipes.

在本实施例中,密封盘120整体作为导电部用于传输消融能量,以进行环状消融,或用于采集组织生理信号,以进行标测。当锚定盘110锚定在左心耳内时,密封盘120能够完全堵住左心耳入口处,封堵左心耳内部的血栓,有效地防止血栓进入左心房。同时密封盘120也能够很好地消融左心耳入口内壁组织,具有很好的消融效果。具体地,左心耳口部组织相对于左心耳内部组织更加规则,表面光滑,对左心耳口部消融,更有利于在口部形成完整的消融带,进而便于在左心耳口部彻底将左心耳与左心房电隔离。In this embodiment, the sealing disc 120 as a whole is used as a conductive part for transmitting ablation energy for circular ablation, or for collecting tissue physiological signals for mapping. When the anchoring disc 110 is anchored in the left atrial appendage, the sealing disc 120 can completely block the entrance of the left atrial appendage, block the thrombus inside the left atrial appendage, and effectively prevent the thrombus from entering the left atrium. At the same time, the sealing disc 120 can also well ablate the inner wall tissue of the inlet of the left atrial appendage, and has a good ablation effect. Specifically, the tissue at the mouth of the left atrial appendage is more regular than the internal tissue of the left atrial appendage, and the surface is smooth. Ablation of the mouth of the left atrial appendage is more conducive to the formation of a complete ablation zone at the mouth of the left atrial appendage. Electrically isolated from the left atrium.

在一些实施例中,锚定盘110上设置有第二导电部114,密封盘120整体作为第一导电部122,第二导电部114和第一导电部122用于分别向组织传输消融能量,或用于标测。第二导电部114与第一导电部122,可用于传输极性不同的电消融能量。第二导电部114与第一导电部122可形成消融电场,以提高消融效果。In some embodiments, the anchoring disc 110 is provided with a second conductive part 114, and the sealing disc 120 as a whole serves as a first conductive part 122, and the second conductive part 114 and the first conductive part 122 are used to respectively transmit ablation energy to the tissue, or for mapping. The second conductive part 114 and the first conductive part 122 can be used to transmit electrical ablation energy with different polarities. The second conductive part 114 and the first conductive part 122 can form an ablation electric field to improve the ablation effect.

在一些实施方式中,比如第二导电部114与第一导电部122用于传输射频能量的实施方式中,第二导电部114和第一导电部122可以用于传输极性相同的消融能量,或者传输相同的消融能量。In some embodiments, for example, in the embodiment where the second conductive part 114 and the first conductive part 122 are used to transmit radiofrequency energy, the second conductive part 114 and the first conductive part 122 can be used to transmit ablation energy with the same polarity, Or deliver the same ablation energy.

在一些实施方式中,第二导电部114和第一导电部122还可以用于标测,即用于采集目标组织的电生理信号。或者在一些实施方式中,兼具消融与标测的功能,比如,第二导电部114及/或第一导电部122中的部分用于标测,部分用于消融,或者第二导电部114及/或第一导电部分122分时用于标测以及消融。In some implementations, the second conductive part 114 and the first conductive part 122 can also be used for mapping, that is, for collecting electrophysiological signals of the target tissue. Or in some embodiments, it has both the functions of ablation and mapping, for example, part of the second conductive part 114 and/or the first conductive part 122 is used for mapping, and part of it is used for ablation, or the second conductive part 114 And/or the first conductive part 122 is used for mapping and ablation in time.

需要说明的是,在一些其他实施例中,第一骨架111也可以整体作为第二导电部114;或者,第二导电部114也可以是设置在第一骨架111外周壁上的电极件,且第二导电部114可以固定连接在第一骨架111的内壁或外周壁上,也可以可拆卸或可活动地连接在第一骨架111上。It should be noted that, in some other embodiments, the first frame 111 can also serve as the second conductive part 114 as a whole; or, the second conductive part 114 can also be an electrode part arranged on the peripheral wall of the first frame 111, and The second conductive part 114 can be fixedly connected to the inner wall or the outer peripheral wall of the first frame 111 , and can also be detachably or movably connected to the first frame 111 .

仍请参照图1和图2,绝缘连接件130的两端分别与锚定盘110和密封盘120连接,具体地,绝缘连接件130的远端连接锚定盘110,近端连接密封盘120,通过绝缘连接件130使第一骨架111上的第二导电部114和第二骨架121上的第一导电部122电隔离。Still referring to FIG. 1 and FIG. 2, both ends of the insulating connector 130 are respectively connected to the anchoring disc 110 and the sealing disc 120, specifically, the distal end of the insulating connector 130 is connected to the anchoring disc 110, and the proximal end is connected to the sealing disc 120. , the second conductive part 114 on the first frame 111 is electrically isolated from the first conductive part 122 on the second frame 121 through the insulating connector 130 .

需要说明的是,在一些其他实施例中,也可以缺省绝缘连接件130,并利用第一骨架111本身除第二导电部114以外的部分进行绝缘,进而使第二导电部114和第一导电部122电隔离。It should be noted that, in some other embodiments, the insulating connector 130 can also be omitted, and the part of the first frame 111 itself except the second conductive part 114 can be used for insulation, so that the second conductive part 114 and the first The conductive portion 122 is electrically isolated.

使用时,通过分别向第二导电部114和第一导电部122传输不同的电消融能量,例如将第二导电部114与外部信号源的输出端正极电导通,将第一导电部122与外部信号源的输出端负极电导通,通过在第二导电部114和第一导电部122之间形成的电场实现消融,消融效果好。During use, different electrical ablation energies are transmitted to the second conductive part 114 and the first conductive part 122 respectively, for example, the second conductive part 114 is electrically connected to the positive output terminal of the external signal source, and the first conductive part 122 is connected to the external signal source. The negative electrode of the output terminal of the signal source is electrically connected, and the ablation is realized through the electric field formed between the second conductive part 114 and the first conductive part 122 , and the ablation effect is good.

另外,通过绝缘连接件130提高了第二导电部114和第一导电部122之间的绝缘性能,降低了第二导电部114和第一导电部122之间实现电连接的可能性,提高了消融成功率和装置的可靠性。In addition, the insulation performance between the second conductive part 114 and the first conductive part 122 is improved by the insulating connector 130, the possibility of realizing an electrical connection between the second conductive part 114 and the first conductive part 122 is reduced, and the Ablation success rate and device reliability.

可以理解的是,在其他一些实施例中,也可以根据需求,向第二导电部114和第一导电部122传输全部参数相同的电信号。It can be understood that, in some other embodiments, electrical signals with all the same parameters can also be transmitted to the second conductive part 114 and the first conductive part 122 according to requirements.

下面对本实施例提供的左心耳封堵消融装置进行进一步说明:The left atrial appendage occlusion ablation device provided in this embodiment is further described below:

图3为图2中Ⅲ处的局部结构放大示意图,图4为本实施例提供的输送器140的结构示意图。FIG. 3 is an enlarged schematic diagram of a local structure at III in FIG. 2 , and FIG. 4 is a schematic structural diagram of the conveyor 140 provided in this embodiment.

请结合参照图1至图4,本实施例提供的左心耳封堵消融装置,还包括输送器140,消融支架100用于装载于输送器140的远端,输送器140用于输送并释放消融支架100至目标位置,即左心耳入口。可以理解的是,在一些实施方式中,还可以将本申请提供的左心耳封堵器消融装置应用于治疗其他组织缺陷。Please refer to FIG. 1 to FIG. 4 , the left atrial appendage occlusion ablation device provided in this embodiment further includes a transporter 140, the ablation support 100 is used to be loaded on the distal end of the transporter 140, and the transporter 140 is used to deliver and release the ablation The stent 100 is moved to the target position, namely the entrance of the left atrial appendage. It can be understood that, in some embodiments, the left atrial appendage occluder ablation device provided in the present application can also be applied to treat other tissue defects.

输送器140包括相互套设的外管143、第一导管142、第二导管141以及手柄144。The conveyor 140 includes an outer tube 143 , a first conduit 142 , a second conduit 141 , and a handle 144 sheathed in each other.

外管143呈管状,外管143的远端能够收容呈径向收缩状态下的锚定盘110和密封盘120。The outer tube 143 is tubular, and the distal end of the outer tube 143 can accommodate the anchoring disc 110 and the sealing disc 120 in a radially contracted state.

第一导管142呈管状,并可活动地穿设于外管143内。第一导管142能够沿轴向相对外管143移动。第一导管142的远端与密封盘120进行可拆卸连接,并与密封盘120导电连接。第一导管142的近端与外部信号源电连接,如此,外部信号源能够通过第一导管142向密封盘120传输消融能量。并且,第一导管142可以带动密封盘120和锚定盘110在外管143内轴向移动,进而使整个消融支架100伸出外管143的远端进行释放,或缩回并收容于外管143内。The first conduit 142 is tubular, and is movably passed through the outer tube 143 . The first conduit 142 can move axially relative to the outer tube 143 . The distal end of the first conduit 142 is detachably connected to the sealing disk 120 and electrically connected to the sealing disk 120 . The proximal end of the first conduit 142 is electrically connected to an external signal source, so that the external signal source can transmit ablation energy to the sealing disc 120 through the first conduit 142 . Moreover, the first catheter 142 can drive the sealing disc 120 and the anchoring disc 110 to move axially in the outer tube 143, so that the entire ablation stent 100 is released from the distal end of the outer tube 143, or retracted and accommodated in the outer tube 143 .

第二导管141呈管状,并活动地穿设于第一导管142内。第二导管141能够沿轴向相对第一导管142移动。第二导管141的远端可以与锚定盘110进行可拆卸连接,并与第二导电部114电连接,从而通过第二导管141向第二导电部114输送电消融能量。可以理解的是,第二导管141也可以不与锚定盘110相连,而直接与第二导电部114进行可拆卸地电连接。The second conduit 141 is tubular and is movably passed through the first conduit 142 . The second conduit 141 can move axially relative to the first conduit 142 . The distal end of the second catheter 141 can be detachably connected to the anchoring disc 110 and electrically connected to the second conductive part 114 , so as to transmit electric ablation energy to the second conductive part 114 through the second catheter 141 . It can be understood that, the second conduit 141 may not be connected with the anchor plate 110 , but directly detachably electrically connected with the second conductive part 114 .

具体地,第一导管142以及第二导管141用于连接外部信号源的不同输出端,比如第一导管142以及第二导管141中的一个用于连接外部信号源输出端的正极,另一个用于连接外部信号源输出端的负极。Specifically, the first conduit 142 and the second conduit 141 are used to connect different output terminals of the external signal source, for example, one of the first conduit 142 and the second conduit 141 is used to connect the positive pole of the output terminal of the external signal source, and the other is used for Connect to the negative terminal of the output terminal of the external signal source.

需要说明的是,第一导管142以及第二导管141也可以用于传递所采集的组织生理信号,以进行标测。It should be noted that the first conduit 142 and the second conduit 141 can also be used to transmit the collected tissue physiological signals for mapping.

手柄144设置在外管143的近端。在植入消融支架100时,第一导管142控制消融支架100收容在外管143的远端。当外管143的远端伸入到左心耳内时,并使外管143的远端停留在左心耳处,通过手柄144操纵外管143后撤,可以实现消融支架100的释放。A handle 144 is provided at the proximal end of the outer tube 143 . When the ablation stent 100 is implanted, the first catheter 142 controls the ablation stent 100 to be accommodated at the distal end of the outer tube 143 . When the distal end of the outer tube 143 is inserted into the left atrial appendage, and the distal end of the outer tube 143 stays at the left atrial appendage, the handle 144 is used to manipulate the outer tube 143 to retreat, so that the ablation stent 100 can be released.

而且,第二导管141设置为管状结构,如此第二导管141的内孔可用于供引导牵引丝穿过,从而可便于将外管143,第一导管142、第二导管141以及消融支架100整体沿着牵引丝移动,并输送至目标位置。Moreover, the second catheter 141 is arranged as a tubular structure, so that the inner hole of the second catheter 141 can be used for guiding the traction wire to pass through, thereby facilitating the integration of the outer tube 143, the first catheter 142, the second catheter 141 and the ablation stent 100 Move along the pulling wire and deliver to the target position.

请参照图3,绝缘连接件130设置有第一导电连接部134。第一导电连接部134用于与输送器140中的第二导管141可拆卸地连接,且第二导管141通过第一导电连接部134与第二导电部114电连接,从而通过第二导管141向第二导电部114输送消融能量,且消融完成后,可将第二导管141从第一导电连接部134处解脱。Referring to FIG. 3 , the insulating connector 130 is provided with a first conductive connecting portion 134 . The first conductive connection part 134 is used to detachably connect with the second conduit 141 in the conveyor 140, and the second conduit 141 is electrically connected to the second conductive part 114 through the first conductive connection part 134, thereby passing through the second conduit 141 The ablation energy is delivered to the second conductive part 114 , and after the ablation is completed, the second catheter 141 can be released from the first conductive connection part 134 .

在一些实施方式中,绝缘连接件130呈筒形,第一导电连接部134设置于绝缘连接件130的内表面。可选地,第一导电连接部134与第二导管141之间螺纹连接,以实现第一导电连接部134与第二导管141之间的可拆卸连接。可以理解的是,在其他一些实施例中,可以根据需求采用其他方式实现第一导电连接部134与第二导管141的可拆卸连接,例如磁性连接或卡接等。In some embodiments, the insulating connector 130 is cylindrical, and the first conductive connecting portion 134 is disposed on an inner surface of the insulating connector 130 . Optionally, the first conductive connection part 134 is threadedly connected to the second conduit 141 to realize a detachable connection between the first conductive connection part 134 and the second conduit 141 . It can be understood that, in some other embodiments, the detachable connection between the first conductive connection part 134 and the second conduit 141 can be implemented in other ways according to requirements, such as magnetic connection or clamping.

绝缘连接件130沿轴向延伸,其近端连接密封盘120,远端连接锚定盘110。绝缘连接件130中设置有绝缘的轴向区段,即实现密封盘120与锚定盘110的绝缘连接,从而提高两盘之间的绝缘性能。“轴向区段”,是指沿着部件的轴向延伸,并环绕轴向一圈的区段,部件沿其轴向延伸,该轴向区段可以设置在绝缘连接件130的内部或绝缘连接件130的表面。本实施方式中,消融支架100沿轴线对称,绝缘连接件130的轴线即为消融支架100的轴线。The insulating connector 130 extends axially, its proximal end is connected to the sealing disc 120 , and its distal end is connected to the anchoring disc 110 . An insulating axial section is provided in the insulating connector 130 , that is, to realize the insulating connection between the sealing disc 120 and the anchoring disc 110 , thereby improving the insulation performance between the two discs. "Axial section" refers to a section that extends along the axial direction of the component and circles around the axial direction. The component extends along its axial direction. The surface of the connector 130. In this embodiment, the ablation stent 100 is symmetrical along the axis, and the axis of the insulating connector 130 is the axis of the ablation stent 100 .

绝缘连接件130包括依次连接的第一连接件131和第二连接件132,即第一连接件131与第二连接件132沿轴向依次连接。第一连接件131连接锚定盘110,即锚定盘110收束连接在第一连接件131上。第二连接件132连接密封盘120,密封盘120收束连接在第二连接件132上。The insulating connecting piece 130 includes a first connecting piece 131 and a second connecting piece 132 connected in sequence, that is, the first connecting piece 131 and the second connecting piece 132 are connected in sequence along the axial direction. The first connecting piece 131 is connected to the anchoring plate 110 , that is, the anchoring plate 110 is constricted and connected to the first connecting piece 131 . The second connecting piece 132 is connected to the sealing disk 120 , and the sealing disk 120 is convergingly connected to the second connecting piece 132 .

进一步地,如图3所示,本实施例中,绝缘连接件130还包括一第三连接件133,第三连接件133设于第一连接件131与第二连接件132之间,以使第一连接件131与第二连接件132间接连接。第三连接件133的远端与第一连接件131的近端连接,第三连接件133的近端与第二连接件132的远端连接。Further, as shown in FIG. 3, in this embodiment, the insulating connector 130 further includes a third connector 133, and the third connector 133 is arranged between the first connector 131 and the second connector 132, so that The first connection part 131 is indirectly connected to the second connection part 132 . A distal end of the third connecting member 133 is connected to a proximal end of the first connecting member 131 , and a proximal end of the third connecting member 133 is connected to a distal end of the second connecting member 132 .

第三连接件133也可以设置多个,并沿轴向依次相接,其中最远端的第三连接件133与第一连接件131相接,最近端的第三连接件133与第二连接件132相接。即在本实施例示出的消融支架100中,第一连接件131通过一个或多个第三连接件133与第二连接件132连接,进而延长绝缘连接件130的长度,实现锚定盘110与密封盘120的间接连接。The third connecting piece 133 can also be provided in multiples, and they are connected successively in the axial direction, wherein the third connecting piece 133 at the farthest end is connected with the first connecting piece 131, and the third connecting piece 133 at the most end is connected with the second connecting piece 131. 132 connected. That is, in the ablation stent 100 shown in this embodiment, the first connecting piece 131 is connected to the second connecting piece 132 through one or more third connecting pieces 133, thereby extending the length of the insulating connecting piece 130, realizing the anchoring plate 110 and the second connecting piece 132. Indirect connection of sealing disk 120 .

在本实施例中,锚定盘110连接于第一连接件131,第一连接件131包括第一导电连接部134,且第一导电连接部134与第二连接件132绝缘连接,从而实现第二导电部114和第一导电部122之间的电隔离。密封盘120的远端与第二连接件132连接。同时第二连接件132呈筒状并形成有供第二导管141穿设的通道,如此第二导管141穿过该第二连接件132的通道与第一导电连接部134连接。在一些实施方式中,第二连接件132用于与密封盘120远端固定连接,收束密封盘120中的多根镍钛合金丝。In this embodiment, the anchor plate 110 is connected to the first connecting part 131, the first connecting part 131 includes a first conductive connecting part 134, and the first conductive connecting part 134 is insulated from the second connecting part 132, so as to realize the second connecting part 134. Electrical isolation between the second conductive portion 114 and the first conductive portion 122 . The distal end of the sealing disc 120 is connected with the second connecting member 132 . At the same time, the second connecting piece 132 is cylindrical and forms a channel through which the second conduit 141 passes, so that the second conduit 141 passes through the channel of the second connecting piece 132 and is connected to the first conductive connecting portion 134 . In some embodiments, the second connecting member 132 is used to be fixedly connected to the distal end of the sealing disk 120 to bundle the multiple nickel-titanium alloy wires in the sealing disk 120 .

具体地,可以设置第一连接件131中的至少部分轴向区段绝缘,从而实现第一导电连接部134与第一导电部122的绝缘连接。在一些实施方式中,该至少部分轴向区段的近端延伸超过第一导电连接部134的近端,即第一导电连接部134的近端,相较于该至少部分轴向区段的近端距离密封盘120更远。Specifically, at least part of the axial section of the first connecting member 131 can be insulated, so as to realize the insulating connection between the first conductive connecting portion 134 and the first conductive portion 122 . In some embodiments, the proximal end of the at least part of the axial section extends beyond the proximal end of the first conductive connection part 134, that is, the proximal end of the first conductive connection part 134, compared to the proximal end of the at least part of the axial section The proximal end is further from the sealing disc 120 .

例如将第一连接件131设置为至少近端绝缘,且第一导电连接部134设置为第一连接件131远端的内壁的螺纹,在此情况下,第二连接件132及第三连接件133的导电与绝缘性能不做限定。该绝缘的轴向区段的近端相对于第一导电连接部134的近端更靠近第一连接件131的近端。该绝缘的轴向区段可以是设置于第一连接件131的绝缘表面,也可以是该轴向区段中的第一连接件131的材质均是绝缘的,该绝缘的轴向区段的远端位置不做限定。For example, the first connector 131 is set to at least the proximal end is insulated, and the first conductive connection portion 134 is set to the thread of the inner wall of the first connector 131 far end, in this case, the second connector 132 and the third connector The conductive and insulating properties of 133 are not limited. The proximal end of the insulating axial section is closer to the proximal end of the first connecting member 131 than to the proximal end of the first conductive connecting portion 134 . The insulating axial section may be provided on the insulating surface of the first connecting member 131, or the material of the first connecting member 131 in the axial section is insulated, and the insulating axial section The remote location is not limited.

在一些实施方式中,在轴向上,该绝缘的轴向区段的远端相对于第一导电连接部134的近端更靠近密封盘120,或者,该绝缘的轴向区段的远端相对于第一导电连接部134的近端更靠近锚定盘110,或者,该绝缘的轴向区段遍布第一连接件131。In some embodiments, in the axial direction, the distal end of the insulating axial section is closer to the sealing disk 120 than the proximal end of the first conductive connection part 134 , or, the distal end of the insulating axial section The proximal end relative to the first conductive connection part 134 is closer to the anchoring disc 110 , or the insulated axial section extends over the first connection part 131 .

在一些实施方式中,也可以将第二连接件132设置为至少部分轴向区段表面绝缘,以实现第一导电连接部134与第一导电部122的绝缘连接,例如将第二连接件132设置为一端由绝缘材料制成,另一端由导电材料制成,此时第一连接件131中除第一导电连接部134的部分的导电性能不做限定,其整体可通过导电材料制成。锚定部113收束于第一连接件131;或者在第一连接件131中位于第一导电连接部134近端的至少部分轴向区段表面绝缘,同时将第二连接件132设置为至少部分轴向区段表面绝缘。In some embodiments, the second connecting member 132 can also be set to insulate at least part of the surface of the axial section, so as to realize the insulating connection between the first conductive connecting part 134 and the first conductive part 122, for example, the second connecting member 132 It is set that one end is made of insulating material and the other end is made of conductive material. At this time, the conductive performance of the part of the first connecting member 131 except the first conductive connecting part 134 is not limited, and the whole can be made of conductive material. The anchoring part 113 is bundled in the first connecting part 131; or in the first connecting part 131, at least part of the axial section surface at the proximal end of the first conductive connecting part 134 is insulated, and the second connecting part 132 is set to at least Part of the axial section is surface insulated.

可以理解的是,在其他一些实施例中,也可以是其中任一一个第三连接件133设置为至少部分轴向区段表面绝缘,以实现第一连接件131和第二连接件132之间的绝缘连接,进而实现第一导电连接部134与第一导电部122之间的绝缘连接。It can be understood that, in some other embodiments, any one of the third connecting parts 133 may also be configured to insulate at least part of the surface of the axial section, so as to realize the connection between the first connecting part 131 and the second connecting part 132. The insulating connection between the first conductive connection part 134 and the first conductive part 122 is further realized.

具体地,可以通过将第一连接件131设置为,其位于第一导电连接部134近端的至少部分轴向区段表面绝缘,以实现第一导电连接部134与第三连接件133的绝缘连接;相应地,也可以将第二连接件132设置为至少部分轴向区段表面绝缘,或者至少一第三连接件133的至少部分轴向区段表面绝缘;甚至上述方式中的两者、三者同时设置,能够实现第一导电连接部134与密封盘120的之间的绝缘,进而实现第一导电连接部134与第一导电部122之间的电隔离。Specifically, the first connecting member 131 can be configured such that at least part of the axial section of the first connecting member 131 at the proximal end of the first conductive connecting part 134 is insulated from the surface, so as to realize the insulation of the first conductive connecting part 134 and the third connecting member 133 Correspondingly, the second connecting member 132 can also be set to insulate at least part of the surface of the axial section, or at least part of the surface of the axial section of at least one third connecting member 133; even the two of the above methods, The simultaneous arrangement of the three can realize the insulation between the first conductive connection part 134 and the sealing disk 120 , and further realize the electrical isolation between the first conductive connection part 134 and the first conductive part 122 .

根据需求,绝缘连接件130的结构即可设置为图3中第一连接件131、第二连接件132与第三连接件133一体结合的结构,或者将绝缘连接件130设置为一体式筒状结构,密封盘120的远端收束于该筒状结构的近端,锚定盘110收束于该筒状结构的远端,同时第一导电连接部134为设置于其内表面的导电材料制成的内螺纹。在本实施例中,第一连接件131为导电材质,实现第二导管141与第二导电部114的电连接,第二导管141通过第一导电连接部134与锚定盘110的第一骨架111电连接。第三连接件133为绝缘材质制成,从而实现第二连接件132与第一连接件131及第一导电连接部134的绝缘连接,如此第二连接件132即可根据需求设置为整体绝缘或整体导电。According to requirements, the structure of the insulating connector 130 can be set as a structure in which the first connecting member 131, the second connecting member 132 and the third connecting member 133 are integrated in FIG. structure, the distal end of the sealing disk 120 is bundled at the proximal end of the cylindrical structure, the anchoring disk 110 is bundled at the distal end of the cylindrical structure, and the first conductive connection part 134 is a conductive material disposed on its inner surface made internal thread. In this embodiment, the first connector 131 is made of conductive material to realize the electrical connection between the second conduit 141 and the second conductive part 114, and the second conduit 141 is connected to the first skeleton of the anchoring plate 110 through the first conductive connection part 134. 111 is electrically connected. The third connecting piece 133 is made of insulating material, so as to realize the insulating connection between the second connecting piece 132 and the first connecting piece 131 and the first conductive connecting portion 134, so that the second connecting piece 132 can be set as an overall insulation or Conductive overall.

在本实施例中,绝缘连接件130上形成有供第二导管141穿设的腔道,且腔道延伸至第一导电连接部134,如此穿设于腔道中的第二导管141能够与第一导电连接部134电连接。具体地,本实施例中的绝缘连接件130包括第一连接件131、第三连接件133和第二连接件132,第一连接件131、第三连接件133和第二连接件132均呈筒状,且第一连接件131、第二连接件132和第三连接件133依次连通以形成该腔道(图3中箭头位置为该腔道,箭头方向表示产品装载过程中第二导管141在该腔道中的穿设方向)。In this embodiment, a lumen for the second conduit 141 to pass through is formed on the insulating connector 130, and the lumen extends to the first conductive connection portion 134, so that the second conduit 141 penetrated in the lumen can be connected to the first conductive connection portion 134. A conductive connecting portion 134 is electrically connected. Specifically, the insulating connector 130 in this embodiment includes a first connector 131, a third connector 133 and a second connector 132, and the first connector 131, the third connector 133 and the second connector 132 are all in the form of Cylindrical, and the first connecting piece 131, the second connecting piece 132 and the third connecting piece 133 communicate in sequence to form the cavity (the position of the arrow in Figure 3 is the cavity, and the direction of the arrow indicates that the second conduit 141 The direction of penetration in the lumen).

绝缘连接件130中相互连接的两个零件之间可拆卸地连接,即在本实施例中,第一连接件131与第三连接件133可拆卸地连接,第二连接件132与第三连接件133可拆卸地连接。可选地,第一连接件131与第三连接件133螺接,第二连接件132与第三连接件133螺接。具体地,第一连接件131设置有第一螺纹部,第三连接件133的远端设置有第二螺纹部,第一螺纹部与第二螺纹部螺纹配合,从而实现第一连接件131与第三连接件133的可拆卸连接。第二连接件132与第三连接件133螺接。具体地,第三连接件133的近端设置有第三螺纹部,第二连接件132设置有第四螺纹部,第三螺纹部于第四螺纹部螺纹配合。The two parts connected to each other in the insulating connector 130 are detachably connected, that is, in this embodiment, the first connector 131 is detachably connected to the third connector 133, and the second connector 132 is connected to the third connector. The member 133 is detachably connected. Optionally, the first connecting piece 131 is screwed to the third connecting piece 133 , and the second connecting piece 132 is screwed to the third connecting piece 133 . Specifically, the first connecting piece 131 is provided with a first threaded portion, and the distal end of the third connecting piece 133 is provided with a second threaded portion, and the first threaded portion and the second threaded portion are screwed together, thereby realizing the first connecting piece 131 and the second threaded portion. The detachable connection of the third connecting piece 133 . The second connecting piece 132 is screwed to the third connecting piece 133 . Specifically, the proximal end of the third connecting part 133 is provided with a third threaded part, the second connecting part 132 is provided with a fourth threaded part, and the third threaded part is threadedly engaged with the fourth threaded part.

具体地,第三连接件133包括沿轴向设置的大管段1331和小管段1332,大管段1331的外径大于小管段1332的外径。第一螺纹部为设置在第一连接件131的近端的内壁上的内螺纹,第二螺纹部为设置在小管段1332的外壁上的外螺纹。第三螺纹部为设置在大管段1331的内壁上的内螺纹,第四螺纹部为设置在第二连接件132的外壁上的外螺纹。可以理解的是,在其他一些实施例中,第三连接件133也可以设置为两端等径的单段管状。Specifically, the third connecting piece 133 includes a large pipe section 1331 and a small pipe section 1332 arranged in the axial direction, and the outer diameter of the large pipe section 1331 is larger than the outer diameter of the small pipe section 1332 . The first threaded part is an internal thread provided on the inner wall of the proximal end of the first connecting member 131 , and the second threaded part is an external thread provided on the outer wall of the small tube section 1332 . The third threaded part is an internal thread provided on the inner wall of the large pipe section 1331 , and the fourth threaded part is an external thread provided on the outer wall of the second connecting piece 132 . It can be understood that, in some other embodiments, the third connecting member 133 may also be configured as a single-section tubular shape with both ends equal in diameter.

进一步地,第一连接件131上设置有第一安装空间1311,锚定盘110的一端伸入第一安装空间1311,从而收束于第一安装空间1311内。具体地,第一连接件131上设置有相互套设的两个环状凸起,两个环状凸起之间形成容置槽,该容置槽内的空间即作为第一安装空间1311,且该第一安装空间1311呈环形。容置槽具有朝向远端的开口,锚定盘110的一端从该开口伸入第一安装空间1311内。可以理解的是,在其他一些实施例中,也可以通过将第一连接件131设置为包括相互套设的内、外套筒,内、外套筒之间形成的环形区域即作为第一安装空间1311,此时内、外套筒中的一个与第二连接件132连接即可。Further, a first installation space 1311 is provided on the first connecting member 131 , and one end of the anchor plate 110 protrudes into the first installation space 1311 , so as to be contained in the first installation space 1311 . Specifically, the first connecting member 131 is provided with two ring-shaped projections nested in each other, and a receiving groove is formed between the two ring-shaped projections, and the space in the receiving groove is used as the first installation space 1311. And the first installation space 1311 is ring-shaped. The accommodating groove has an opening towards the distal end, and one end of the anchoring plate 110 protrudes into the first installation space 1311 through the opening. It can be understood that, in some other embodiments, the first connecting member 131 can also be configured to include inner and outer sleeves nested in each other, and the annular area formed between the inner and outer sleeves can be used as the first installation Space 1311, at this time, one of the inner sleeve and the outer sleeve can be connected with the second connecting piece 132 .

进一步地,第二连接件132上形成有第二安装空间1323,密封盘120的远端收束于该第二安装空间1323。具体地,第二连接件132包括相互套设的内套筒1321和外套筒1322,内套筒1321与外套筒1322之间形成第二安装空间1323,该第二安装空间1323呈环形。内套筒1321与外套筒1322中的一个与第三连接件133连接。在本实施例中,第四螺纹部设置在外套筒1322的外周壁上,即第二连接件132中的外套筒1322与第三连接件133连接。可以理解的是,在其他一些实施例中,也可以将第二连接件132设置为一体结构,其上开设容置槽,容置槽内的空间即为第二安装空间1323。Further, a second installation space 1323 is formed on the second connecting member 132 , and the distal end of the sealing disc 120 is converged in the second installation space 1323 . Specifically, the second connecting member 132 includes an inner sleeve 1321 and an outer sleeve 1322 nested with each other, and a second installation space 1323 is formed between the inner sleeve 1321 and the outer sleeve 1322, and the second installation space 1323 is annular. One of the inner sleeve 1321 and the outer sleeve 1322 is connected to the third connecting member 133 . In this embodiment, the fourth threaded portion is disposed on the outer peripheral wall of the outer sleeve 1322 , that is, the outer sleeve 1322 in the second connecting member 132 is connected to the third connecting member 133 . It can be understood that, in some other embodiments, the second connecting member 132 can also be provided as an integral structure, and a receiving groove is opened on it, and the space in the receiving groove is the second installation space 1323 .

请参照图1和图2,在本实施例中,密封盘120包括消融支架100的近端部分,锚定盘110包括消融支架100的远端部分,第二导电部114为部分锚定盘110,第一导电部122为全部密封盘120。即第二导电部114为锚定盘110的至少一部分,第一导电部122为密封盘120的全部。可以理解的是,第二导电部114也可以为锚定盘110的全部。Please refer to FIG. 1 and FIG. 2 , in this embodiment, the sealing disk 120 includes the proximal portion of the ablation stent 100 , the anchoring disk 110 includes the distal portion of the ablation stent 100 , and the second conductive part 114 is part of the anchoring disk 110 , the first conductive portion 122 is all the sealing disc 120 . That is, the second conductive part 114 is at least a part of the anchoring disk 110 , and the first conductive part 122 is the whole of the sealing disk 120 . It can be understood that the second conductive portion 114 may also be the entirety of the anchor plate 110 .

进一步地,在消融支架100中,与第二导电部114以及第一导电部122对应的区域作为作用区域,同时消融支架100中作用区域以外的区域为绝缘区域。可以理解的是,在一些实施例中,也可以通过将绝缘区域中的至少部分消融支架100设置为由绝缘材料制成,比如,采用绝缘的可降解材料制成绝缘区域中的至少部分消融支架100。Further, in the ablation stent 100 , the area corresponding to the second conductive portion 114 and the first conductive portion 122 is used as an active area, and the area of the ablation stent 100 other than the active area is an insulating area. It can be understood that, in some embodiments, at least part of the ablation stent 100 in the insulating region can also be made of an insulating material, for example, at least part of the ablation stent in the insulating region is made of an insulating degradable material 100.

具体地,在本实施例中,第一骨架111与第二骨架121之间通过绝缘连接件130连接,在本实施方式中,第一连接件131用于收束锚定盘110中第一骨架111的端部,第二连接件132用于收束密封盘120中第二骨架121的远端。Specifically, in this embodiment, the first skeleton 111 and the second skeleton 121 are connected through an insulating connecting piece 130. In this embodiment, the first connecting piece 131 is used to constrict the first skeleton in the anchoring plate 110. 111 , the second connecting piece 132 is used to constrict the distal end of the second skeleton 121 in the sealing disc 120 .

在本实施例中,第一骨架111整体为金属材质,其部分表面作为第二导电部114,即第一骨架111中作为第二导电部114的部分未做绝缘处理,其余部分的表面进行绝缘处理,从而使该部分表面绝缘,避免第二导电部114的导电面积过大,影响消融效果的问题。由于第一骨架111为金属材质,第一连接件131整体导电,第二导电部114与第一导电连接部134即可直接通过第一骨架111实现电导通。In this embodiment, the first frame 111 is made of metal as a whole, and part of its surface is used as the second conductive part 114, that is, the part of the first frame 111 used as the second conductive part 114 is not insulated, and the surface of the rest is insulated. treatment, so as to insulate the surface of this part, and avoid the problem that the conductive area of the second conductive part 114 is too large, which affects the ablation effect. Since the first frame 111 is made of metal, the first connecting member 131 conducts electricity as a whole, and the second conductive portion 114 and the first conductive connection portion 134 can directly realize electrical conduction through the first frame 111 .

可以理解的是,在其他一些实施例中,也可以仅将第一骨架111的部分设置为金属材质,其余部分设置为绝缘材质,以使该部分的表面绝缘,如此则需额外设置电线实现第一导电连接部134与第二导电部114的电连接。It can be understood that, in some other embodiments, only a part of the first frame 111 can be made of metal material, and the rest can be made of insulating material, so as to insulate the surface of this part. A conductive connecting portion 134 is electrically connected to the second conductive portion 114 .

进一步地,第一骨架111用于贴靠左心耳内壁组织位置的部分作为第二导电部114,第二导电部114呈环状,如此第二导电部114对应形成的消融带成环状,有助于提高左心耳消融的效果。第二导电部114的外周覆盖有阻流膜126,阻流膜126具有孔隙,使得阻流膜126至少能够过滤血栓,即避免左心耳内的血栓进入左心房,还能保证第二导电部114能够向组织释放消融能量。Furthermore, the part of the first skeleton 111 that is used to abut against the inner wall tissue of the left atrial appendage is used as the second conductive part 114, and the second conductive part 114 is in the shape of a ring, so that the corresponding ablation zone formed by the second conductive part 114 is in the shape of a ring. Help to improve the effect of left atrial appendage ablation. The outer periphery of the second conductive part 114 is covered with a flow-blocking film 126, and the flow-blocking film 126 has pores, so that the flow-blocking film 126 can at least filter the thrombus, that is, prevent the thrombus in the left atrial appendage from entering the left atrium, and also ensure that the second conductive part 114 Capable of delivering ablative energy to tissue.

需要说明的是,在本实施例中,第一骨架111的部分作为第二导电部114,其余部分表面绝缘,可以理解的是,在其他一些实施例中,也可以将第一骨架111的全部同时作为第二导电部114,以用于向组织释放消融能量。It should be noted that, in this embodiment, part of the first skeleton 111 is used as the second conductive part 114, and the rest of the surface is insulated. It can be understood that in some other embodiments, the entire first skeleton 111 can also At the same time, it serves as the second conductive part 114 for releasing ablation energy to the tissue.

请参照图1和图2,对于密封盘120,第二骨架121整体为金属材质,第二骨架121整体作为第一导电部122。由于第二骨架121为金属材质,第一导电部122即可直接通过第二骨架121实现电导通,无需额外设置电线。Please refer to FIG. 1 and FIG. 2 , for the sealing disk 120 , the second frame 121 is made of metal as a whole, and the second frame 121 as a whole serves as the first conductive portion 122 . Since the second frame 121 is made of metal, the first conductive part 122 can directly realize electrical conduction through the second frame 121 without additional wires.

需要说明的是,在本实施例中,第二骨架121需要表面绝缘的部分通过绝缘处理实现。本实施方式中,将密封盘120设置为还包括绝缘膜125,绝缘膜125包覆于第二骨架121远端的外周壁上,绝缘膜125能够阻隔在第二骨架121的远端与第一骨架111的近端之间,绝缘膜125用于隔离第一骨架111和第二骨架121,避免膨胀后的第一骨架111和第二骨架121直接进行接触。It should be noted that, in this embodiment, the part of the second skeleton 121 that needs surface insulation is realized through insulation treatment. In this embodiment, the sealing disc 120 is set to further include an insulating film 125, and the insulating film 125 is coated on the outer peripheral wall of the distal end of the second framework 121, and the insulating film 125 can block the connection between the distal end of the second framework 121 and the first Between the proximal ends of the skeletons 111 , the insulating film 125 is used to isolate the first skeleton 111 and the second skeleton 121 , preventing the expanded first skeleton 111 and the second skeleton 121 from directly contacting each other.

在本实施例中,第二骨架121为通过金属丝编织制成的双层网盘,其包括近侧骨架和远侧骨架,近侧骨架位于远侧骨架的近端的一侧,且近侧骨架与远侧骨架在周缘处连接。可选地,密封盘120的外形的轴向投影呈梯形,从而匹配左心耳入口部位置的解剖结构,通过密封盘120将左心耳入口封闭。In this embodiment, the second skeleton 121 is a double-layer mesh disk made of wire weaving, which includes a proximal skeleton and a distal skeleton, the proximal skeleton is located on one side of the proximal end of the distal skeleton, and the proximal The frame is peripherally connected to the distal frame. Optionally, the axial projection of the outer shape of the sealing disk 120 is trapezoidal, so as to match the anatomical structure of the inlet of the left atrial appendage, and the inlet of the left atrial appendage is sealed by the sealing disk 120 .

需要说明的是,在本实施例中,第二骨架121为采用金属丝编织制成,可以理解的是,在其他一些实施例中,也可以根据需求采用其他方式制成第二骨架121,例如通过管材切割制成。It should be noted that, in this embodiment, the second frame 121 is braided with metal wires. It can be understood that in some other embodiments, the second frame 121 can also be made in other ways according to requirements, for example Manufactured by pipe cutting.

请结合参照图1至图4,在本实施例中,密封盘120还包括第二导电连接部124,第二骨架121的近端与第二导电连接部124连接,具体地,第二骨架121的近端收束于第二导电连接部124处。第二导电连接部124用于与第一导管142可拆卸地连接,外部信号源依次通过第一导管142、第二导电连接部124电连接于第一导电部122。第二导电连接部124也可以用于传递密封盘120所采集的组织生理信号。Please refer to FIGS. 1 to 4 in combination. In this embodiment, the sealing disc 120 further includes a second conductive connection portion 124, and the proximal end of the second skeleton 121 is connected to the second conductive connection portion 124. Specifically, the second skeleton 121 The proximal end converges at the second conductive connection part 124 . The second conductive connecting portion 124 is used for detachably connecting with the first conduit 142 , and the external signal source is electrically connected to the first conductive portion 122 sequentially through the first conduit 142 and the second conductive connecting portion 124 . The second conductive connection part 124 can also be used to transmit tissue physiological signals collected by the sealing disc 120 .

具体地,第二导电连接部124为环形筒状结构,其内形成有沿轴向延伸的通孔,该通孔可供第二导管141穿过。第一导管142与第二导电连接部124可拆卸地连接,如此当消融支架100在输送器140的作用下释放于左心耳处,消融支架100的植入完成,并进行消融后,可将第一导管142与第二导电连接部124解脱,从而将消融支架100留置在左心耳处,并将第一导管142以及第二导管141从体内撤离。Specifically, the second conductive connecting portion 124 is an annular cylindrical structure, in which a through hole extending along the axial direction is formed, and the through hole can allow the second conduit 141 to pass through. The first catheter 142 is detachably connected to the second conductive connection part 124, so that when the ablation stent 100 is released at the left atrial appendage under the action of the conveyor 140, the implantation of the ablation stent 100 is completed, and the ablation can be performed. A catheter 142 is released from the second conductive connection part 124, so that the ablation stent 100 is left at the left atrial appendage, and the first catheter 142 and the second catheter 141 are withdrawn from the body.

可选地,第二导电连接部124与第一导管142螺纹连接。具体地,第二导电连接部124的内壁设置有第六螺纹部,从而通过第六螺纹部与第一导管142的螺接,实现第二导电连接部124与第一导管142的可拆卸连接。可以理解的是,在其他一些实施例中,也可以根据需求,选用磁性连接或卡接等方式实现第二导电连接部124与第一导管142的可拆卸连接。Optionally, the second conductive connection part 124 is screwed to the first conduit 142 . Specifically, the inner wall of the second conductive connecting portion 124 is provided with a sixth threaded portion, so that the detachable connection between the second conductive connecting portion 124 and the first conduit 142 is realized through the screw connection of the sixth threaded portion and the first conduit 142 . It can be understood that, in some other embodiments, the detachable connection between the second conductive connection part 124 and the first conduit 142 can also be realized by magnetic connection or clamping according to requirements.

请参照图1,在本实施例中,密封盘120还包括设置于第二骨架121内的阻流膜126。具体地,本实施方式中,阻流膜126沿径向设置于第二骨架121的内部。在其他实施方式中,阻流膜126还可以包覆于第二骨架121的外侧。阻流膜126至少可以用于阻断左心耳内部的血栓流出,同时根据阻流膜126孔隙率的不同,甚至可以阻断左心耳内的血流流入左心室。具体地,由于密封盘120的第二骨架121为网状结构,其上形成有多个网孔,通过设置阻流膜126将网孔封闭,从而阻挡阻流膜126远端的血栓向近端移动,以避免左心耳内的血栓等进入左心室。需要说明的是,当第二骨架121上的网孔足够小、足够密时,可以不设置阻流膜126。Please refer to FIG. 1 , in this embodiment, the sealing disc 120 further includes a flow blocking film 126 disposed in the second frame 121 . Specifically, in this embodiment, the flow blocking film 126 is arranged radially inside the second framework 121 . In other embodiments, the flow blocking film 126 can also cover the outside of the second framework 121 . The blocking membrane 126 can at least be used to block the outflow of the thrombus in the left atrial appendage, and at the same time, according to the difference in the porosity of the blocking membrane 126, it can even block the blood flow in the left atrial appendage from flowing into the left ventricle. Specifically, since the second skeleton 121 of the sealing disk 120 is a mesh structure, a plurality of mesh holes are formed on it, and the mesh holes are closed by setting the flow blocking film 126, thereby preventing the thrombus at the distal end of the flow blocking film 126 from moving to the proximal end. Move to avoid thrombus, etc. in the left atrial appendage entering the left ventricle. It should be noted that when the mesh holes on the second skeleton 121 are small enough and dense enough, the flow blocking film 126 may not be provided.

锚定盘110的远端设置有阻流作用的阻流膜126,阻流膜126设置于第一骨架111远端,从而有助于阻挡锚定盘110远端的血栓向靠近密封盘120的方向移动。进一步地,锚定盘110上的阻流膜126设置为带孔的结构,以使第二导电部114能够向内壁组织释放消融能量。需要说明的是,在一些实施例中,阻流膜126的材料以及绝缘处理所用的材质可以设置为相同。The distal end of the anchoring disc 110 is provided with a blocking film 126 with a blocking effect, and the blocking film 126 is arranged at the distal end of the first skeleton 111, thereby helping to block the thrombus at the distal end of the anchoring disc 110 from moving toward the sealing disc 120. direction to move. Further, the blocking film 126 on the anchoring disk 110 is configured as a structure with holes, so that the second conductive part 114 can release ablation energy to the inner wall tissue. It should be noted that, in some embodiments, the material of the blocking film 126 and the material used for the insulation treatment can be set to be the same.

图5为图2中第一骨架111的结构示意图。FIG. 5 is a schematic structural diagram of the first framework 111 in FIG. 2 .

请结合参照图1和图5,在本实施例中,第一骨架111包括多个支撑部112以及多个锚定部113,多个锚定部113围绕设置在多个支撑部112的外周。Please refer to FIG. 1 and FIG. 5 in combination. In this embodiment, the first frame 111 includes a plurality of support portions 112 and a plurality of anchor portions 113 , and the plurality of anchor portions 113 are disposed around the outer circumference of the plurality of support portions 112 .

每一支撑部112均包括支撑杆1121以及设置在支撑杆1121一端的第一分支1122和第二分支1123,第一分支1122和第二分支1123均呈杆状,如此形成的支撑部112的外形大致为Y字形。Each support portion 112 includes a support rod 1121 and a first branch 1122 and a second branch 1123 arranged at one end of the support rod 1121. The first branch 1122 and the second branch 1123 are rod-shaped, and the shape of the support portion 112 thus formed is Roughly Y-shaped.

具体地,支撑杆1121包括相对的第一端和第二端,多个支撑杆1121的第一端连接于绝缘连接件130,多个支撑杆1121的第二端沿径向向外扩散,逐渐远离锚定盘110的轴线,形成类似喇叭的形状,且第一分支1122和第二分支1123连接在对应支撑杆1121的第二端处。在本实施例中,第一端即为支撑杆1121的近端,第二端即为支撑杆1121的远端。可以理解的是,在变更实施方式中,不限定第一端为支撑杆1121的近端,第二端为支撑杆1121的远端。Specifically, the support rods 1121 include opposite first ends and second ends, the first ends of the plurality of support rods 1121 are connected to the insulating connector 130, and the second ends of the plurality of support rods 1121 spread radially outward, gradually Away from the axis of the anchoring disc 110 , a horn-like shape is formed, and the first branch 1122 and the second branch 1123 are connected at the second ends of the corresponding support rods 1121 . In this embodiment, the first end is the proximal end of the support rod 1121 , and the second end is the distal end of the support rod 1121 . It can be understood that, in the modified embodiment, the first end is not limited to the proximal end of the support rod 1121 , and the second end is not limited to the distal end of the support rod 1121 .

每一第一分支1122远离支撑杆1121的一端与相邻一个支撑部112的第二分支1123远离支撑杆1121的一端连接,且连接处形成第一连接点1124。每个锚定部113连接于对应的第一连接点1124,并朝向近端延伸。如此形成的第一骨架111为双层结构,多个支撑杆1121围绕形成第一骨架111的内层,多个锚定部113围绕形成第一骨架111的外层。第一骨架111中,锚定部113中用于抵接左心耳内壁组织的部分作为第二导电部114,第二导电部114呈环形,从而通过第二导电部114形成沿第一骨架111周向延伸的环形消融带。An end of each first branch 1122 away from the support rod 1121 is connected to an end of a second branch 1123 of an adjacent support portion 112 away from the support rod 1121 , and the connection forms a first connection point 1124 . Each anchoring portion 113 is connected to the corresponding first connection point 1124 and extends toward the proximal end. The first frame 111 formed in this way has a double-layer structure, a plurality of support rods 1121 surround the inner layer of the first frame 111 , and a plurality of anchoring portions 113 surround the outer layer of the first frame 111 . In the first frame 111, the part of the anchoring portion 113 that is used to abut against the inner wall tissue of the left atrial appendage is used as the second conductive portion 114, and the second conductive portion 114 is ring-shaped, thereby forming a ring around the first frame 111 through the second conductive portion 114. Extended circular ablation zone.

可选地,第一骨架111还包括连接环118,多个支撑杆1121的近端均连接于该连接环118,如此将多个支撑杆1121的近端连接在一起。锚定盘110与绝缘连接件130连接时,连接环118容置于第一安装空间1311内,从而将第一骨架111的内层近端收束于第一安装空间1311。可以理解的是,在其他一些实施例中,也可以不设置连接环118,而直接将支撑杆1121的近端端部收束限位在第一安装空间1311内,实现锚定盘110与绝缘连接件130的连接。可选地,连接环118、多个支撑部112和多个锚定部113通过管材切割一体制成。Optionally, the first frame 111 further includes a connecting ring 118, and the proximal ends of the plurality of support rods 1121 are all connected to the connection ring 118, thus connecting the proximal ends of the plurality of support rods 1121 together. When the anchor plate 110 is connected to the insulating connector 130 , the connecting ring 118 is accommodated in the first installation space 1311 , so that the proximal end of the inner layer of the first frame 111 is contained in the first installation space 1311 . It can be understood that, in some other embodiments, the connecting ring 118 may not be provided, but the proximal end of the support rod 1121 is directly restrained in the first installation space 1311, so as to realize the insulation between the anchor plate 110 and the first installation space 1311. Connection of connector 130 . Optionally, the connecting ring 118, the plurality of support portions 112 and the plurality of anchor portions 113 are integrally made by cutting a pipe.

进一步地,多个锚定部113分为多组,每组锚定部113包含相邻的两个锚定部113,且每组锚定部113中的两个锚定部113的近端连接,从而形成网格结构。进一步地,每组锚定部113中,两个锚定部113的连接处向第一骨架111的轴线方向弯折延伸,即向内侧弯折呈弯钩状,从而减轻锚定部113末端对组织的刺激与损伤。Further, the plurality of anchoring parts 113 are divided into multiple groups, each group of anchoring parts 113 includes two adjacent anchoring parts 113, and the proximal ends of the two anchoring parts 113 in each group of anchoring parts 113 are connected , forming a grid structure. Further, in each group of anchoring parts 113, the junction of the two anchoring parts 113 is bent and extended toward the axis of the first skeleton 111, that is, bent inward to form a hook shape, thereby reducing the tension of the ends of the anchoring parts 113. Irritation and damage to tissue.

进一步地,锚定盘110还包括设置在第一骨架111径向外侧的倒刺117,倒刺117的远端连接于锚定部113,倒刺117的近端位于第一骨架111的径向外侧。具体地,倒刺117连接在锚定部113上,当左心耳封堵消融装置植入左心耳处后,倒刺117刺入左心耳组织中,避免锚定盘110脱离左心耳的内壁组织。Further, the anchoring plate 110 also includes a barb 117 arranged radially outside the first frame 111, the distal end of the barb 117 is connected to the anchoring part 113, and the proximal end of the barb 117 is located in the radial direction of the first frame 111. outside. Specifically, the barb 117 is connected to the anchoring part 113, and when the LAA occlusion ablation device is implanted in the LAA, the barb 117 penetrates into the LAA tissue, preventing the anchoring disc 110 from detaching from the inner wall tissue of the LAA.

根据本实施例提供的一种左心耳封堵消融装置,左心耳封堵消融装置的工作原理是:According to the left atrial appendage blockage ablation device provided in this embodiment, the working principle of the left atrial appendage blockage ablation device is:

左心耳封堵消融装置的第一导电连接部134与第二导管141电连接,第二导电连接部124与第一导管142电连接。使用前,消融支架100呈压缩状容置在输送器140内,使用时,通过输送器140将消融支架100输送并释放于体内左心耳口部,此时消融支架100的锚定盘110呈膨胀状态锚固于左心耳内,且锚定盘110的倒刺117刺入左心耳的内壁组织中;消融支架100的密封盘120呈膨胀状态位于左心耳入口处,以通过密封盘120封闭左心耳入口。The first conductive connection part 134 of the left atrial appendage occlusion ablation device is electrically connected to the second catheter 141 , and the second conductive connection part 124 is electrically connected to the first catheter 142 . Before use, the ablation stent 100 is stored in the conveyor 140 in a compressed state. During use, the ablation stent 100 is transported and released to the mouth of the left atrial appendage in the body through the conveyor 140. At this time, the anchoring plate 110 of the ablation stent 100 is expanded. The state is anchored in the left atrial appendage, and the barb 117 of the anchoring disc 110 penetrates into the inner wall tissue of the left atrial appendage; the sealing disc 120 of the ablation stent 100 is in an expanded state and is located at the entrance of the left atrial appendage, so as to seal the entrance of the left atrial appendage through the sealing disc 120 .

植入完成后,外部能量源依次通过第一导管142和第二导电连接部124向第一导电部122输送电消融能量,同时第二导管141通过第一导电连接部134向第二导电部114输送电消融能量,且第二导电部114和第一导电部122的电消融能量不同,比如第二导电部114与外接信号源的输送端正极电导通,则第一导电部122与外接信号源的输送端负极电导通;若第二导电部114与负极电导通,则第一导电部122与正极电导通。如此在第二导电部114和第一导电部122之间形成电场以实现消融,消融效果好。消融完成后,将第一导电连接部134与第二导管141解脱,并将第二导电连接部124与第一导管142解脱,从而将第二导管141和第一导管142从体内撤离,左心耳封堵消融装置留置于患者体内。After the implantation is completed, the external energy source sequentially transmits electrical ablation energy to the first conductive part 122 through the first catheter 142 and the second conductive connection part 124, and at the same time, the second catheter 141 sends electrical ablation energy to the second conductive part 114 through the first conductive connection part 134. The electrical ablation energy is transmitted, and the electrical ablation energy of the second conductive part 114 and the first conductive part 122 are different. The negative electrode of the delivery end is electrically connected; if the second conductive part 114 is electrically connected to the negative electrode, then the first conductive part 122 is electrically connected to the positive electrode. In this way, an electric field is formed between the second conductive part 114 and the first conductive part 122 to realize ablation, and the ablation effect is good. After the ablation is completed, the first conductive connection part 134 is released from the second catheter 141, and the second conductive connection part 124 is released from the first catheter 142, so that the second catheter 141 and the first catheter 142 are withdrawn from the body, and the left atrial appendage The occlusion ablation device is left in the patient.

本实施例提供的一种左心耳封堵消融装置至少具有以下优点:A left atrial appendage occlusion ablation device provided in this embodiment has at least the following advantages:

本实施例提供的左心耳封堵消融装置,利用锚定盘110在左心耳内释放,锚定盘110可锚定左心耳的组织内壁,利用密封盘120在左心耳入口处释放,可利用密封盘120封堵左心耳入口,进而将整个左心耳封堵消融装置固定在左心耳处。同时密封盘120整体导电并用于传输消融能量,对左心耳入口处及左心耳内的组织进行消融,可以极大地提高消融效果。密封盘作为第一导电部也可以用于采集组织生理信号,以进行标测。此外,该左心耳封堵消融装置将消融与封堵结合,简化了“消融+左心耳封堵”一站式治疗手术的程序,有助于降低手术难度。The left atrial appendage occlusion ablation device provided in this embodiment is released in the left atrial appendage by using the anchoring disc 110. The anchoring disc 110 can anchor the tissue inner wall of the left atrial appendage, and is released at the entrance of the left atrial appendage by using the sealing disc 120. The disc 120 blocks the entrance of the left atrial appendage, and then fixes the entire left atrial appendage blockage ablation device at the left atrial appendage. At the same time, the sealing disc 120 conducts electricity as a whole and is used to transmit ablation energy, and ablate the tissue at the entrance of the left atrial appendage and inside the left atrial appendage, which can greatly improve the ablation effect. The sealing disc, as the first conductive part, can also be used to collect tissue physiological signals for mapping. In addition, the left atrial appendage occlusion ablation device combines ablation and occlusion, which simplifies the procedure of "ablation + left atrial appendage occlusion" one-stop treatment and helps reduce the difficulty of surgery.

实施例2Example 2

图6为本实施例提供的左心耳封堵消融装置中绝缘连接件130处的结构示意图。FIG. 6 is a schematic structural diagram of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment.

请参照图6,并结合图3,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,绝缘连接件130的结构不同。Please refer to FIG. 6 and in combination with FIG. 3 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the insulating connector 130 is different .

在本实施例中,绝缘连接件130中相互连接的零件之间过盈配合,从而使绝缘连接件130中相互连接的零件可拆卸地连接。即第一连接件131与第三连接件133之间过盈配合,第三连接件133与第二连接件132之间过盈配合。可以理解的是,在其他一些实施例中,第一连接件131和第三连接件133之间的连接方式也可以设置为与第三连接件133和第二连接件132之间的连接方式不同。In this embodiment, the interconnected parts of the insulating connector 130 are interference-fitted, so that the interconnected parts of the insulating connector 130 are detachably connected. That is, there is an interference fit between the first connecting piece 131 and the third connecting piece 133 , and an interference fit between the third connecting piece 133 and the second connecting piece 132 . It can be understood that, in some other embodiments, the connection mode between the first connection part 131 and the third connection part 133 can also be set to be different from the connection mode between the third connection part 133 and the second connection part 132 .

具体地,第一连接件131的近端的内周壁与第三连接件133的小管段1332的外周壁过盈配合。第三连接件133的大管段1331的内周壁与第二连接件132的外套筒1322的外周壁过盈配合。Specifically, the inner peripheral wall of the proximal end of the first connecting piece 131 is in interference fit with the outer peripheral wall of the small tube section 1332 of the third connecting piece 133 . The inner peripheral wall of the large pipe section 1331 of the third connecting piece 133 is in interference fit with the outer peripheral wall of the outer sleeve 1322 of the second connecting piece 132 .

实施例3Example 3

图7为本实施例提供的左心耳封堵消融装置中绝缘连接件130处的结构示意图。FIG. 7 is a schematic structural diagram of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment.

请参照图7,并结合图3,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,绝缘连接件130的结构不同。Please refer to FIG. 7 and in combination with FIG. 3 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the insulating connector 130 is different .

在本实施例中,绝缘连接件130中相互连接的零件之间卡接,从而使绝缘连接件130中相互连接的零件可拆卸地连接。即第一连接件131与第三连接件133卡接,第三连接件133与第二连接件132卡接。In this embodiment, the parts connected to each other in the insulating connector 130 are clamped, so that the parts connected to each other in the insulating connector 130 are detachably connected. That is, the first connecting part 131 is engaged with the third connecting part 133 , and the third connecting part 133 is engaged with the second connecting part 132 .

具体地,第一连接件131内设置有卡接槽,第三连接件133的远端外侧设置有卡接楔块,通过卡接槽与卡接楔块的卡合,实现第一连接件131与第三连接件133的卡接,如此使第一连接件131和第三连接件133在轴向方向上止位。第三连接件133的近端内侧设置有卡接槽,第二连接件132的外侧设置有卡接楔块,通过第三连接件133的卡接槽与第二连接件132的卡接楔块的卡合,实现第三连接件133与第二连接件132的卡接,如此使第二连接件132和第三连接件133在轴向方向上止位。Specifically, the first connecting piece 131 is provided with a locking groove, and the third connecting piece 133 is provided with a locking wedge on the outer side of the distal end. The clamping with the third connecting piece 133 makes the first connecting piece 131 and the third connecting piece 133 stop in the axial direction. The inner side of the proximal end of the third connecting piece 133 is provided with a locking groove, and the outer side of the second connecting piece 132 is provided with a locking wedge, through which the locking groove of the third connecting piece 133 and the locking wedge of the second connecting piece 132 The engagement of the third connecting piece 133 and the second connecting piece 132 is realized, so that the second connecting piece 132 and the third connecting piece 133 stop in the axial direction.

需要说明的是,此处并不对卡接的具体结构进行限制,可以理解的是,在其他一些实施例中,也可以根据需求采用其他结构实现绝缘连接件130中相互连接的零件之间的卡接配合。It should be noted that the specific structure of the snap connection is not limited here, and it can be understood that in some other embodiments, other structures can also be used to realize the snap connection between the interconnected parts in the insulating connector 130. Then cooperate.

实施例4Example 4

图8为本实施例提供的左心耳封堵消融装置中绝缘连接件130处的结构示意图。FIG. 8 is a schematic structural diagram of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment.

请参照图8,并结合图3,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,绝缘连接件130的结构不同。Please refer to FIG. 8 and in combination with FIG. 3 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the insulating connector 130 is different .

在本实施例中,绝缘连接件130中相互连接的零件之间枢接,即第一连接件131与第三连接件133枢接,第三连接件133与第二连接件132枢接,如此第一连接件131能够相对第三连接件133绕轴向转动,第二连接件132能够相对第三连接件133绕轴向转动。In this embodiment, the interconnected parts in the insulating connector 130 are pivotally connected, that is, the first connector 131 is pivotally connected to the third connector 133, and the third connector 133 is pivotally connected to the second connector 132, so The first connecting part 131 can rotate axially relative to the third connecting part 133 , and the second connecting part 132 can rotate axially relative to the third connecting part 133 .

具体地,第三连接件133的近端和远端分别设置有枢接槽。第一连接件131的近端设置有第一枢接头,通过第一枢接头与第三连接件133远端的枢接槽枢接,实现第一连接件131与第三连接件133的枢接。第二连接件132的远端设置有第二枢接头,通过第二枢接头与第三连接件133的近端的枢接槽枢接,实现第三连接件133与第二连接件132的枢接。Specifically, the proximal end and the distal end of the third connecting member 133 are respectively provided with pivoting slots. The proximal end of the first connecting member 131 is provided with a first pivot joint, and the pivot connection between the first connecting member 131 and the third connecting member 133 is realized through the pivot connection between the first pivot joint and the pivot groove at the far end of the third connecting member 133 . The distal end of the second connecting member 132 is provided with a second pivot joint, and the pivot connection between the third connecting member 133 and the second connecting member 132 is realized through the pivot connection between the second pivot joint and the near-end pivot groove of the third connecting member 133. catch.

需要说明的是,绝缘连接件130轴心处均仍设有通孔,该通孔可供第二导管141穿过。It should be noted that a through hole is still provided at the axial center of the insulating connector 130 , and the through hole can allow the second conduit 141 to pass through.

实施例5Example 5

图9为本实施例提供的左心耳封堵消融装置中绝缘连接件130处的结构示意图。图10为图9中左心耳封堵消融装置的绝缘连接件130拉伸以及扭转活动时的结构示意图。FIG. 9 is a schematic structural diagram of the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment. FIG. 10 is a schematic structural view of the insulating connector 130 of the left atrial appendage occlusion ablation device in FIG. 9 when stretched and twisted.

请参照图9和图10,并结合图3,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,绝缘连接件130的结构不同。Please refer to FIG. 9 and FIG. 10 , and in combination with FIG. 3 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the insulating connector 130 structure is different.

在本实施例中,绝缘连接件130中相互连接的零件之间柔性连接,如此可设置为第一连接件131与第三连接件133柔性连接,第三连接件133与第二连接件132柔性连接。In this embodiment, the interconnected parts in the insulating connector 130 are flexibly connected, so that the first connector 131 and the third connector 133 are flexibly connected, and the third connector 133 and the second connector 132 are flexibly connected. connect.

具体地,第三连接件133整体为柔性橡胶结构,第一连接件131的近端设置有第一连接头,第二连接件132的远端设置有第二连接头,第三连接件133硫化成型在第一连接头和第二连接头之间,且第三连接件133的远端包覆第一连接头,第三连接件133的近端包覆第二连接头,如此连接于第一连接件131的锚定盘110以及连接于第二连接件132的密封盘120能够相对拉伸以及扭转活动(如图10所示)。Specifically, the third connector 133 is a flexible rubber structure as a whole, the proximal end of the first connector 131 is provided with a first connector, the distal end of the second connector 132 is provided with a second connector, and the third connector 133 is vulcanized. It is molded between the first connector and the second connector, and the far end of the third connector 133 covers the first connector, and the proximal end of the third connector 133 covers the second connector, so that it is connected to the first connector. The anchor disc 110 of the connecting member 131 and the sealing disc 120 connected to the second connecting member 132 can be relatively stretched and torsionally movable (as shown in FIG. 10 ).

需要说明的是,绝缘连接件130轴心处均仍设有通孔,该通孔可供第二导管141穿过。It should be noted that a through hole is still provided at the axial center of the insulating connector 130 , and the through hole can allow the second conduit 141 to pass through.

还需要说明的是,在本实施例中,第三连接件133通过硫化直接成型在第一连接头和第二连接头上,第三连接件133与第一连接件131以及第二连接件132的连接不可拆卸,可以理解的是,在其他一些实施例中,也可以根据需求采用其他方式实现各零件之间的柔性可拆卸连接。It should also be noted that, in this embodiment, the third connecting piece 133 is directly molded on the first connecting head and the second connecting head through vulcanization, and the third connecting piece 133 is connected with the first connecting piece 131 and the second connecting piece 132 The connection is not detachable, it can be understood that in some other embodiments, other ways can also be used to realize the flexible and detachable connection between the parts according to requirements.

实施例6Example 6

图11为本实施例提供的左心耳封堵消融装置的结构示意图,图12为图11的左心耳封堵消融装置去掉阻流膜126以及绝缘膜125后的剖面结构示意图。FIG. 11 is a schematic structural view of the left atrial appendage blockage ablation device provided in this embodiment, and FIG. 12 is a schematic cross-sectional structure view of the left atrial appendage blockage ablation device in FIG.

请参照图11和图12,本实施例也提供了一种左心耳封堵消融装置,,其与实施例1提供的左心耳封堵消融装置的主要区别在于,第二导电部114的形成方式不同。Please refer to FIG. 11 and FIG. 12 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the second conductive part 114 is formed in a manner different.

在本实施例中,第二导电部114为设置于第一骨架111的电极件。具体地,锚定盘110还包括设置在第一骨架111上的第一电极件116,从而采用第一电极件116作为第二导电部114。锚定盘110可以设置为仅第一骨架111中未与第一电极件116接触的部分的表面绝缘,也可以设置为第一骨架111整体的表面均绝缘,也可以设置为第一骨架111整体导电。In this embodiment, the second conductive portion 114 is an electrode component disposed on the first frame 111 . Specifically, the anchoring plate 110 further includes a first electrode member 116 disposed on the first skeleton 111 , so that the first electrode member 116 is used as the second conductive portion 114 . The anchoring plate 110 can be set so that only the surface of the part of the first frame 111 that is not in contact with the first electrode member 116 is insulated, or it can be set so that the entire surface of the first frame 111 is insulated, or it can be set as the whole of the first frame 111 conduct electricity.

在本实施例中,锚定盘110上设置有阻流膜126,第一电极件116位于阻流膜126外侧,即阻流膜126设置在第一电极件116与第一骨架111之间。第一骨架111中与第一电极件116接触的部分,即可看作第一电极件116在锚定部113上的投影部分。如图12所示,在锚定盘110省略阻流膜126的情况下,则第一骨架111与第一电极件116相交的部分为第一骨架111与第一电极件116接触的部分,相应地,第一骨架111中未与第一电极件116相交的部分即为第一骨架111未与第一电极件116接触的部分。In this embodiment, the anchor plate 110 is provided with a flow blocking film 126 , and the first electrode member 116 is located outside the flow blocking film 126 , that is, the flow blocking film 126 is disposed between the first electrode member 116 and the first frame 111 . The portion of the first frame 111 that is in contact with the first electrode member 116 can be regarded as the projected portion of the first electrode member 116 on the anchoring portion 113 . As shown in FIG. 12 , in the case where the anchoring plate 110 omits the flow blocking film 126, the part where the first skeleton 111 intersects with the first electrode member 116 is the part where the first skeleton 111 contacts the first electrode member 116, correspondingly Specifically, the portion of the first skeleton 111 that does not intersect with the first electrode member 116 is the portion of the first skeleton 111 that is not in contact with the first electrode member 116 .

第二导电部114沿着左心耳消融装置的周向弯折延伸。在本实施例中,第一电极件116沿着第一骨架111的周向弯折延伸,如此设置在第一骨架111外周的第一电极件116在第一骨架111的轴向上延伸一定范围,进而通过第一电极件116形成的消融区域沿第一骨架111的轴向延伸形成带状。The second conductive part 114 bends and extends along the circumferential direction of the left atrial appendage ablation device. In this embodiment, the first pole piece 116 is bent and extended along the circumferential direction of the first frame 111, so that the first pole piece 116 arranged on the outer periphery of the first frame 111 extends in a certain range in the axial direction of the first frame 111, and then The ablation area formed by the first electrode member 116 extends along the axial direction of the first frame 111 to form a strip shape.

具体地,第一电极件116为导电丝弯折形成的锯齿状结构。可以理解的是,在其他一些实施例中,也可以将第一电极件116设置为弯折延伸的其他外形,例如波浪形。Specifically, the first electrode member 116 is a zigzag structure formed by bending a conductive wire. It can be understood that, in some other embodiments, the first electrode member 116 may also be configured in other shapes that are bent and extended, such as a wave shape.

可选地,第一电极件116为电极丝,或条形的电极片,可以理解的是,第一电极件116的类型也可以根据需求选取,例如设置为杆状电极、阵列环状电极或环状消融导管等。可选地,第一电极件116延伸至第一导电连接部134,并通过焊接与第一导电连接部134连接,实现第一电极件116与第一导电连接部134的电连接。Optionally, the first electrode member 116 is an electrode wire, or a strip-shaped electrode sheet. It can be understood that the type of the first electrode member 116 can also be selected according to requirements, for example, it is set as a rod-shaped electrode, an array ring electrode or Loop ablation catheter, etc. Optionally, the first electrode piece 116 extends to the first conductive connection portion 134 and is connected to the first conductive connection portion 134 by welding to realize the electrical connection between the first electrode piece 116 and the first conductive connection portion 134 .

在本实施方式中,第一电极件116通过与作用区域中的第一骨架111电连接,两者之间的阻流膜126中可设置孔隙以保证两者之间的电导通。在一种实施方式中,第一连接件131表面绝缘,及/或第一骨架111表面绝缘的情况下,第一电极件116延伸至第一导电连接部134,或者通过导线连接至第一导电连接部134以传输消融能量。In this embodiment, the first electrode member 116 is electrically connected to the first skeleton 111 in the active area, and pores can be provided in the flow blocking film 126 between the two to ensure electrical conduction between the two. In one embodiment, the surface of the first connecting member 131 is insulated, and/or when the surface of the first skeleton 111 is insulated, the first electrode member 116 extends to the first conductive connection part 134, or is connected to the first conductive connection part 134 through a wire. The connection part 134 is used to transmit ablation energy.

需要说明的是,本实施例中提供的左心耳封堵消融装置中绝缘连接件130为实施例1提供的绝缘连接件130结构,可以理解的是,其也可以采用实施例2-实施例6所提供的绝缘连接件130的结构。It should be noted that the insulating connector 130 in the left atrial appendage occlusion ablation device provided in this embodiment is the structure of the insulating connector 130 provided in Embodiment 1. It can be understood that it can also adopt Embodiment 2-Embodiment 6 The structure of the insulating connector 130 is provided.

实施例7Example 7

图13为本实施例提供的左心耳封堵消融装置的结构示意图。Fig. 13 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment.

请参照图13,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,绝缘连接件130的结构不同。Please refer to FIG. 13 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the insulating connector 130 is different.

在本实施例中,第一导电连接部134可拆卸地设于第一连接件131上。第一导电连接部134呈筒状,其内开设有轴向延伸的通孔。第一导电连接部134整体为导电材料制成,第一导电连接部134用于与第一骨架111上的第二导电部114导电连接。In this embodiment, the first conductive connecting portion 134 is detachably disposed on the first connecting member 131 . The first conductive connecting portion 134 is cylindrical and has a through hole extending axially therein. The first conductive connection part 134 is made of conductive material as a whole, and the first conductive connection part 134 is used for conductive connection with the second conductive part 114 on the first frame 111 .

在一些实施例中,第一连接件131与第三连接件133整体为绝缘材质,第二连接件132可以不做限制,进而实现第一导电连接部134与密封盘120的电隔离。由于第一连接件131与第三连接件133整体绝缘,故可增大第一导电连接部134与密封盘120之间的绝缘距离,进而可提高锚定盘110上的第二导电部114与密封盘120之间的绝缘距离和绝缘性能。In some embodiments, the first connecting part 131 and the third connecting part 133 are made of insulating material, and the second connecting part 132 may not be limited, so as to achieve electrical isolation between the first conductive connecting part 134 and the sealing disk 120 . Since the first connecting part 131 and the third connecting part 133 are integrally insulated, the insulation distance between the first conductive connecting part 134 and the sealing disc 120 can be increased, thereby improving the connection between the second conductive part 114 on the anchoring disc 110 and the sealing disc 120. The insulation distance and insulation performance between the sealing disks 120.

需要说明的是,第二导管141可以与第一导电连接部134相连,并导电连接,进而与第二导电部114电连接,或通过第一导电连接部134与第一电极件116电连接。It should be noted that, the second conduit 141 can be connected to the first conductive connection part 134 and electrically connected, and then electrically connected to the second conductive part 114 , or electrically connected to the first electrode member 116 through the first conductive connection part 134 .

在其他一些实施例中,第一连接件131与第二连接件132整体为导电材质,第三连接件133至少表面绝缘,以实现第一连接件131与第二连接件132的绝缘连接,进而实现第一导电连接部134与密封盘120的电隔离。在本实施例中,第三连接件133整体均为绝缘材质。可以理解的是,也可以根据其他方式实现第二连接件132与第一导电连接部134之间的绝缘连接。In some other embodiments, the first connecting member 131 and the second connecting member 132 are made of conductive material as a whole, and the third connecting member 133 is insulated at least on the surface, so as to realize the insulated connection between the first connecting member 131 and the second connecting member 132, and further Electrical isolation of the first conductive connection portion 134 from the sealing disc 120 is achieved. In this embodiment, the third connecting member 133 is made of insulating material as a whole. It can be understood that the insulating connection between the second connecting member 132 and the first conductive connecting portion 134 can also be realized in other ways.

实施例8Example 8

图14示出了本实施例提供的左心耳封堵消融装置的结构示意图。为清楚起见,图14中省略显示左心耳封堵消融装置的阻流膜126以及绝缘膜125等膜结构。Fig. 14 shows a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment. For the sake of clarity, the membrane structures such as the flow blocking membrane 126 and the insulating membrane 125 of the left atrial appendage occlusion ablation device are omitted in FIG. 14 .

请参照图14,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,绝缘连接件130的结构不同。本实施方式提供的绝缘连接件130,适用于第一电极件116作为第二导电部114的实施方式,或第一电极件116作为独立于第二导电部114的第三导电部的实施方式。Please refer to FIG. 14 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the insulating connector 130 is different. The insulating connector 130 provided in this embodiment is applicable to an embodiment in which the first electrode member 116 is used as the second conductive portion 114 , or an embodiment in which the first electrode member 116 is used as a third conductive portion independent of the second conductive portion 114 .

在本实施例中,绝缘连接件130还包括设于第一连接件131和第一导电连接部134之间的第四连接件135。第四连接件135可拆卸地设于第一连接件131上。第一导电连接部134可拆卸地设于第四连接件135上。即第四连接件135夹持在第一连接件131和第一导电连接部134之间。In this embodiment, the insulating connection part 130 further includes a fourth connection part 135 disposed between the first connection part 131 and the first conductive connection part 134 . The fourth connecting member 135 is detachably disposed on the first connecting member 131 . The first conductive connecting portion 134 is detachably disposed on the fourth connecting member 135 . That is, the fourth connecting piece 135 is sandwiched between the first connecting piece 131 and the first conductive connecting portion 134 .

其中,第一连接件131用于收束第一骨架111,第二连接件132用于收束第二骨架121,第一连接件131与第二连接件132采用导电的金属材料制成,能够收束骨架比较牢固,有利于提高密封盘120与锚定盘110的机械性能。Wherein, the first connecting piece 131 is used for constricting the first skeleton 111, and the second connecting piece 132 is used for constricting the second skeleton 121. The first connecting piece 131 and the second connecting piece 132 are made of conductive metal materials, which can The converging skeleton is relatively strong, which is beneficial to improving the mechanical properties of the sealing disc 120 and the anchoring disc 110 .

第三连接件133整体绝缘,用于将密封盘120与锚定盘110之间电隔离。The third connecting piece 133 is integrally insulated and used for electrically isolating the sealing disc 120 from the anchoring disc 110 .

第一导电连接部134整体导电,用于与锚定盘110外围设置的第一电极件116实现电连接,第一电极件116直接延伸至第一导电连接部134,或者通过设置额外的导线连接至第一导电连接部134。The first conductive connection part 134 conducts electricity as a whole, and is used to realize electrical connection with the first electrode part 116 provided on the periphery of the anchor plate 110. The first electrode part 116 directly extends to the first conductive connection part 134, or is connected by an additional wire. to the first conductive connection portion 134 .

第四连接件135整体绝缘,用于将两端的第一连接件131与第一导电连接部134电隔离,使得锚定盘110中的第一骨架111与第一导电连接部134以及第一电极件116电隔离。The fourth connecting piece 135 is integrally insulated, and is used to electrically isolate the first connecting piece 131 at both ends from the first conductive connecting portion 134, so that the first skeleton 111 in the anchoring plate 110 is connected to the first conductive connecting portion 134 and the first electrode Element 116 is electrically isolated.

请参照图14,并结合图4,在一些实施例中,仅第一电极件116导电的情况下,第一骨架111可以绝缘。此时,第一电极件116作为第二导电部114进行消融。第二导管141可以直接与第一导电连接部134相连,并导电连接,再通过第一导电连接部134与第一电极件116电连接。因第一电极件116设置于第一骨架111的外周或远端,故可增大第二导电部114与密封盘120之间的距离,即增大锚定盘110上导电部分与密封盘120之间的距离,进而提高第一导电部122与第二导电部114之间的绝缘性能。Please refer to FIG. 14 in conjunction with FIG. 4 , in some embodiments, only the first electrode member 116 is conductive, and the first frame 111 can be insulated. At this time, the first electrode member 116 serves as the second conductive portion 114 for ablation. The second conduit 141 may be directly connected to the first conductive connection part 134 and electrically connected, and then electrically connected to the first electrode member 116 through the first conductive connection part 134 . Since the first electrode member 116 is arranged on the outer periphery or the distal end of the first skeleton 111, the distance between the second conductive part 114 and the sealing disk 120 can be increased, that is, the distance between the conductive part on the anchoring disk 110 and the sealing disk 120 can be increased. The distance between the first conductive part 122 and the second conductive part 114 is further improved.

仍请参照图14,并结合图4,在另一些实施例中,第一电极件116和第一骨架111均导电的情况下,第一骨架111上的整体或部分作为第二导电部114,第一电极件116作为第三导电部,并与第二导电部114可以电隔离。Still referring to FIG. 14 , in conjunction with FIG. 4 , in some other embodiments, when both the first electrode member 116 and the first skeleton 111 are conductive, the whole or part of the first skeleton 111 serves as the second conductive part 114 , The first electrode member 116 serves as the third conductive part and can be electrically isolated from the second conductive part 114 .

此时,第一连接件131、第二连接件132及第一导电连接部134整体导电,第三连接件133和第四连接件135整体绝缘。第三连接件133使第一连接件131和第二连接件132电隔离,第四连接件135使第一连接件131和第一导电连接部134电隔离。同时,输送器140还包括穿设于第二导管141内的第三导管。第三导管活动地穿设于第二导管141内,并能够沿轴向相对第二导管141移动。第一导管142与第二导电连接部124相连并导电连接,进而为第一导电部122提供消融能量。第二导管141与第一连接件131相连并导电连接,进而为第二导电部114提供消融能量。第三导管与第一导电连接部134相连并导电连接,进而为第一电极件116(即第三导电部)提供消融能量。At this time, the first connecting part 131 , the second connecting part 132 and the first conductive connecting part 134 are integrally conductive, and the third connecting part 133 and the fourth connecting part 135 are integrally insulated. The third connection part 133 electrically isolates the first connection part 131 from the second connection part 132 , and the fourth connection part 135 electrically isolates the first connection part 131 from the first conductive connection part 134 . Meanwhile, the conveyor 140 also includes a third conduit passing through the second conduit 141 . The third conduit is movably passed through the second conduit 141 and can move relative to the second conduit 141 along the axial direction. The first catheter 142 is connected to the second conductive connection part 124 and electrically connected, so as to provide ablation energy for the first conductive part 122 . The second catheter 141 is connected to the first connecting member 131 and electrically connected, so as to provide ablation energy for the second conductive part 114 . The third conduit is connected to the first conductive connection part 134 and is conductively connected to provide ablation energy for the first electrode member 116 (ie, the third conductive part).

第二导电部114、第一导电部122及第三导电部可以相互电隔离,进而同时实现消融,消融效果好。在一些实施例中,在由近端至远端的方向上,第一导电部122、第二导电部114及第三导电部可以依次交替连接正负信号源输出端,进而在第一导电部122与第二导电部114之间,以及第二导电部114与第三导电部之间形成两个电场以实现消融,进而提高消融效果。The second conductive part 114 , the first conductive part 122 and the third conductive part can be electrically isolated from each other, so as to realize ablation at the same time, and the ablation effect is good. In some embodiments, in the direction from the proximal end to the distal end, the first conductive part 122, the second conductive part 114 and the third conductive part can be alternately connected to the positive and negative signal source output ends in turn, and then the first conductive part Two electric fields are formed between 122 and the second conductive part 114 and between the second conductive part 114 and the third conductive part to realize ablation, thereby improving the ablation effect.

在其他一些实施例中,第二导电部114、第一导电部122及第三导电部也可以传输极性相同的电消融信号。In some other embodiments, the second conductive part 114 , the first conductive part 122 and the third conductive part may also transmit electrical ablation signals with the same polarity.

实施例9Example 9

图15为本实施例提供的左心耳封堵消融装置的结构示意图,图16为图15的左心耳封堵消融装置去掉覆膜(比如阻流膜)后的结构示意图。FIG. 15 is a schematic structural view of the left atrial appendage blockage ablation device provided in this embodiment, and FIG. 16 is a structural schematic view of the left atrial appendage blockage ablation device in FIG.

请参照图15和图16,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,锚定盘110的结构。Please refer to FIG. 15 and FIG. 16 , this embodiment also provides a left atrial appendage occlusion ablation device, which is mainly different from the left atrial appendage occlusion ablation device provided in Embodiment 1 in the structure of the anchoring disc 110 .

在本实施例中,锚定盘110的第一骨架111采用金属丝编织制成,且第一骨架111的远端沿径向向内收束连接在一起,从而使第一骨架111呈笼状。具体地,锚定盘110还包括远端连接件119,远端连接件119设置在锚定盘110远端,编织形成第一骨架111的金属丝的远端沿径向向内收束于远端连接件119处,且远端连接件119位于金属丝围成的笼形内部。In this embodiment, the first frame 111 of the anchoring plate 110 is made of braided metal wires, and the distal ends of the first frame 111 are radially inwardly constricted and connected together, so that the first frame 111 is in a cage shape. . Specifically, the anchoring disc 110 also includes a distal connecting piece 119, the distal connecting member 119 is arranged at the distal end of the anchoring disc 110, and the distal end of the wire braided to form the first skeleton 111 is converged radially inward at the distal end. The end connecting piece 119 is located, and the distal connecting piece 119 is located inside the cage surrounded by the metal wire.

同时,在该实施例示出的左心耳封堵消融装置中,锚定盘110上设置有第一电极件116,通过该第一电极件116作为第二导电部114,以进行消融能量的传输。在一些其他实施例中,也可以采用第一骨架111的部分或全部作为第二导电部114,第一电极件116作为与第二导电部114电隔离的第三导电部。Meanwhile, in the left atrial appendage blockage ablation device shown in this embodiment, the first electrode member 116 is provided on the anchor plate 110 , and the first electrode member 116 is used as the second conductive part 114 to transmit ablation energy. In some other embodiments, part or all of the first skeleton 111 may also be used as the second conductive portion 114 , and the first electrode member 116 may be used as a third conductive portion electrically isolated from the second conductive portion 114 .

实施例10Example 10

图17为本实施例提供的左心耳封堵消融装置的结构示意图,图18为图17的左心耳封堵消融装置去掉覆膜(比如阻流膜)后的结构示意图。FIG. 17 is a schematic structural view of the left atrial appendage blockage ablation device provided in this embodiment, and FIG. 18 is a structural schematic view of the left atrial appendage blockage ablation device in FIG.

请参照图17和图18,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,锚定盘110和密封盘120的结构不同。Please refer to FIG. 17 and FIG. 18 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the anchor disc 110 and the sealing disc 120 The structure is different.

在本实施例中,锚定盘110的第一骨架111采用金属丝编织制成,且编织成的第一骨架111为内外双层。具体地,金属丝沿锚定盘110的近端向远端扩散延伸,形成第一骨架111的内层,然后从远端向近端翻折绕回,编织形成第一骨架111的外层。In this embodiment, the first skeleton 111 of the anchoring plate 110 is made of braided metal wire, and the braided first skeleton 111 is double-layered inside and outside. Specifically, the metal wire diffuses and extends from the proximal end to the distal end of the anchoring disc 110 to form the inner layer of the first skeleton 111 , and then turns back from the distal end to the proximal end to weave to form the outer layer of the first skeleton 111 .

在本实施例中,密封盘120的第二骨架121为金属丝编织成型的结构,且密封盘120包括背向锚定盘110的盘面127、朝向锚定盘110的盘底128以及连接在盘面127与盘底128之间的腰部129。其中,盘面127的直径大于盘底128的直径,且盘面127的直径略大于左心耳的内径,植入后盘面127压住左心耳出口处,盘底128塞入左心耳内,且盘底128的直径与左心耳内径大致一致。In this embodiment, the second skeleton 121 of the sealing disc 120 is a wire braided structure, and the sealing disc 120 includes a disc surface 127 facing away from the anchoring disc 110, a disc bottom 128 facing the anchoring disc 110, and a disc surface 128 connected to the disc surface. Waist 129 between 127 and dish bottom 128. Wherein, the diameter of the disk surface 127 is larger than the diameter of the disk bottom 128, and the diameter of the disk surface 127 is slightly larger than the inner diameter of the left atrial appendage. The diameter is approximately the same as the inner diameter of the left atrial appendage.

同时,本实施例示出的左心耳封堵消融装置中,锚定盘110上的第二导电部114为第一骨架111的部分,可以理解的是,也可以根据需求采用具体选择骨架或者额外设置电极件的方式。密封盘120的第二骨架121整体作为第一导电部122。At the same time, in the left atrial appendage occlusion ablation device shown in this embodiment, the second conductive part 114 on the anchor plate 110 is part of the first frame 111. It can be understood that a specific frame or an additional setting can also be used according to requirements. way of electrodes. The whole second frame 121 of the sealing disc 120 serves as the first conductive part 122 .

实施例11Example 11

图19为本实施例提供的左心耳封堵消融装置的结构示意图,图20为图19的左心耳封堵消融装置去掉覆膜(比如阻流膜)后的结构示意图。FIG. 19 is a schematic structural view of the left atrial appendage occlusion ablation device provided in this embodiment, and FIG. 20 is a structural schematic view of the left atrial appendage occlusion ablation device in FIG.

请参照图19和图20,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,锚定盘110的结构不同。Please refer to FIG. 19 and FIG. 20 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the anchoring disc 110 is different.

在本实施例中,锚定盘110的第一骨架111采用金属丝编织制成,第一实施方式中锚定盘110的第一骨架111采用管材切割而成。本申请中的第一骨架111与第二骨架121,不限定制作工艺,第一骨架111可以编织或切割而成,第二骨架121也可以编织或切割而成。In this embodiment, the first skeleton 111 of the anchoring disc 110 is made of braided metal wire, while in the first embodiment the first skeleton 111 of the anchoring disc 110 is cut from a pipe. The first skeleton 111 and the second skeleton 121 in this application do not limit the manufacturing process, the first skeleton 111 can be woven or cut, and the second skeleton 121 can also be woven or cut.

如图19-图20所示,第一骨架111远端呈敞口状,即第一骨架111的远端具有开口,以使第一骨架111的外形呈杯状。As shown in FIGS. 19-20 , the distal end of the first frame 111 is open, that is, the distal end of the first frame 111 has an opening, so that the shape of the first frame 111 is cup-shaped.

同时,在该实施例示出的左心耳封堵消融装置中,锚定盘110可根据需求采用第一骨架111的部分或者全部作为第二导电部114,或者也可以采用外接的第一电极件116作为第二导电部114。At the same time, in the left atrial appendage blockage ablation device shown in this embodiment, the anchor plate 110 can use part or all of the first skeleton 111 as the second conductive part 114 according to requirements, or can also use the external first electrode part 116 as the second conductive portion 114 .

实施例12Example 12

图21为本实施例提供的左心耳封堵消融装置去掉覆膜后的结构示意图,图22为图21的左心耳封堵消融装置中第一骨架111的结构示意图。FIG. 21 is a schematic diagram of the structure of the left atrial appendage ablation device provided in this embodiment after removing the film, and FIG. 22 is a schematic diagram of the structure of the first frame 111 in the left atrial appendage ablation device in FIG. 21 .

请参照图21和图22,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,锚定盘110的结构不同。Please refer to FIG. 21 and FIG. 22 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the anchoring disc 110 is different.

在本实施例中,锚定盘110采用管材切割制成,与实施例的第一骨架111不同的是,本实施例中第一骨架111的相邻两个锚定部113独立设置,即其任一锚定部113未与其他锚定部113直接连接。锚定部113呈杆状向近端延伸,且锚定部113远离第一连接点1124的一端向内弯折。In this embodiment, the anchoring plate 110 is made by cutting a pipe. The difference from the first frame 111 in this embodiment is that the two adjacent anchoring parts 113 of the first frame 111 in this embodiment are independently provided, that is, their Any anchor portion 113 is not directly connected to other anchor portions 113 . The anchoring portion 113 is rod-shaped and extends proximally, and an end of the anchoring portion 113 away from the first connection point 1124 is bent inward.

同理地,本实施例提供的左心耳封堵消融装置中第二导电部114也可以根据需求采用骨架或者额外设置电极件的方式。Similarly, the second conductive part 114 in the left atrial appendage occlusion ablation device provided in this embodiment can also adopt a skeleton or additionally provide electrode parts according to requirements.

实施例13Example 13

图23为本实施例提供的左心耳封堵消融装置的结构示意图。Fig. 23 is a schematic structural diagram of the left atrial appendage occlusion ablation device provided in this embodiment.

请参照图23,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,锚定盘110的结构不同,具体地,锚定部113的结构与实施例1不同。Please refer to FIG. 23 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Example 1 in that the structure of the anchor disc 110 is different, specifically, the anchor The structure of the fixed portion 113 is different from that of the first embodiment.

在本实施例中,锚定盘110采用管材切割制成,同时每一锚定部113均包括远端相互连接的第三分支1132和第四分支1133,第三分支1132和第四分支1133的连接处形成第二连接点1134,第二连接点1134与第一连接点1124连接。同时,每一第三分支1132的近端与相邻的一个锚定部113的第四分支1133的近端连接,如此在相邻两个锚定部113之间围成网格结构。In this embodiment, the anchoring plate 110 is made by cutting a pipe, and each anchoring portion 113 includes a third branch 1132 and a fourth branch 1133 whose distal ends are connected to each other. The third branch 1132 and the fourth branch 1133 The connection forms a second connection point 1134 connected to the first connection point 1124 . Meanwhile, the proximal end of each third branch 1132 is connected to the proximal end of the fourth branch 1133 of an adjacent anchoring portion 113 , thus forming a grid structure between two adjacent anchoring portions 113 .

进一步地,锚定部113还包括连接杆1131,连接杆1131的两端分别于第一连接点1124和第二连接点1134连接,如此相邻两个锚定部113之间围成的网格呈六边形。倒刺117设置在连接杆1131上。Further, the anchoring part 113 also includes a connecting rod 1131, and the two ends of the connecting rod 1131 are respectively connected to the first connecting point 1124 and the second connecting point 1134, so that the grid formed between two adjacent anchoring parts 113 It is hexagonal. The barb 117 is disposed on the connecting rod 1131 .

在第一分支1122和第二分支1123上的电极丝作为第一电极件116。具体地,电极丝的一部分沿第一分支1122的周向螺旋绕设,从而缠绕于第一分支1122。电极丝的另一部分沿第二分支1123的周向螺旋绕设,从而缠绕于第二分支1123。该第一电极件116可以作为第二导电部114。可以理解的是,在其他一些实施例中,也可以采用其他方式的第二导电部114,例如实施例1或者实施例7提供的第二导电部114的结构。The electrode wires on the first branch 1122 and the second branch 1123 serve as the first electrode member 116 . Specifically, a part of the electrode wire is helically wound along the circumferential direction of the first branch 1122 , so as to be wound around the first branch 1122 . The other part of the electrode wire is spirally wound along the circumferential direction of the second branch 1123 , so as to be wound around the second branch 1123 . The first electrode member 116 can serve as the second conductive portion 114 . It can be understood that, in some other embodiments, other forms of the second conductive portion 114 may also be used, such as the structure of the second conductive portion 114 provided in Embodiment 1 or Embodiment 7.

实施例14Example 14

图24为本实施例提供的左心耳封堵消融装置的结构示意图,图25为图24的左心耳封堵消融装置去掉覆膜后的结构示意图。FIG. 24 is a schematic structural view of the left atrial appendage occlusion ablation device provided in this embodiment, and FIG. 25 is a structural schematic view of the left atrial appendage occlusion ablation device in FIG. 24 after removing the membrane.

请参照图24和图25,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,消融支架100的结构不同。Please refer to FIG. 24 and FIG. 25 , this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the structure of the ablation bracket 100 is different.

在本实施例中,消融支架100为三盘式结构,第二导电部114和第一导电部122分别设置在该三个盘中的任意两个上。同时第二导电部114可根据需求选用骨架或者额外设置电极件的方式。In this embodiment, the ablation stent 100 has a three-disk structure, and the second conductive part 114 and the first conductive part 122 are respectively arranged on any two of the three discs. At the same time, the second conductive part 114 can choose a skeleton or an additional electrode part according to requirements.

同理地,本实施例提供的左心耳封堵消融装置也可以采用其他实施例中的相关结构。具体地,消融支架100的三个盘,由远端至近端分别为依次设置的第一盘161、第二盘162和第三盘163。Similarly, the left atrial appendage occlusion ablation device provided in this embodiment may also adopt related structures in other embodiments. Specifically, the three discs of the ablation stent 100 are respectively a first disc 161 , a second disc 162 and a third disc 163 arranged in sequence from the distal end to the proximal end.

在一些实施例中,第一盘161与第二盘162之间通过绝缘连接件130连接并电隔离,绝缘连接件130也可以用绝缘骨架来代替。此时,第二盘162与第三盘163之间是否电隔离并不限制。In some embodiments, the first plate 161 and the second plate 162 are connected and electrically isolated by an insulating connector 130 , and the insulating connector 130 may also be replaced by an insulating frame. At this time, whether the second disk 162 and the third disk 163 are electrically isolated is not limited.

在一些实施例中,第二盘162与第三盘163之间通过另一绝缘连接件130连接并电隔离,绝缘连接件130也可以用绝缘骨架来代替。此时,第一盘161与第二盘162之间是否电隔离并不限制。In some embodiments, the second disk 162 and the third disk 163 are connected and electrically isolated by another insulating connector 130 , and the insulating connector 130 may also be replaced by an insulating frame. At this time, whether the first disk 161 and the second disk 162 are electrically isolated is not limited.

在一些实施例中,第一盘161与第二盘162之间通过绝缘连接件130连接并电隔离,同时第二盘162与第三盘163之间通过另一绝缘连接件130连接并电隔离,绝缘连接件130也可以用绝缘骨架来代替。在一些实施例中,第三盘163可作为密封盘120,第二盘162和第一盘161均可以作为锚定盘110。第三盘163整体导电并作为第一导电部122。第二导电部114可以设于第二盘162或第一盘161中的任一一个上。In some embodiments, the first disk 161 and the second disk 162 are connected and electrically isolated through an insulating connector 130, while the second disk 162 and the third disk 163 are connected and electrically isolated through another insulating connector 130. , The insulating connector 130 may also be replaced by an insulating frame. In some embodiments, the third disc 163 can serve as the sealing disc 120 , and both the second disc 162 and the first disc 161 can serve as the anchoring disc 110 . The third plate 163 conducts electricity as a whole and serves as the first conductive portion 122 . The second conductive part 114 may be disposed on any one of the second plate 162 or the first plate 161 .

如图24与图25所示,在本实施方式中,第一电极件116作为第二导电部114设置在第一盘161上,第二电极件123作为第三导电部设置在第二盘162上。可以理解的是,也可以仅设置第一电极件116,而不设置第二电极件123。As shown in FIG. 24 and FIG. 25 , in this embodiment, the first electrode member 116 is disposed on the first plate 161 as the second conductive portion 114 , and the second electrode member 123 is disposed on the second plate 162 as the third conductive portion. superior. It can be understood that only the first pole piece 116 may be provided without the second pole piece 123 .

当第一电极件116作为第二导电部114设置在第一盘161上时,可以仅在第一盘161与第二盘162之间绝缘连接,而第二盘162与第三盘163之间是否电隔离并不限制。或者,可以仅在第二盘162与第三盘163之间绝缘连接,而第一盘161与第二盘162之间是否电隔离并不限制。或者,第二盘162设置为绝缘材质,第一盘161与第二盘162之间是否电隔离并不限制,且第二盘162与第三盘163之间是否电隔离也并不限制。When the first pole member 116 is provided on the first plate 161 as the second conductive part 114, it can only be insulated and connected between the first plate 161 and the second plate 162, and between the second plate 162 and the third plate 163 Whether it is electrically isolated or not is not limited. Alternatively, only the insulating connection between the second pad 162 and the third pad 163 may be made, and whether the first pad 161 and the second pad 162 are electrically isolated is not limited. Alternatively, the second disk 162 is made of an insulating material, and there is no limitation on whether the first disk 161 is electrically isolated from the second disk 162 , and whether the second disk 162 is electrically isolated from the third disk 163 is also not limited.

本实施方式中,第一盘161用于锚定在左心耳内部,第三盘163作为密封盘120用于封堵左心耳开口,第二盘162位于左心耳开口附近。In this embodiment, the first disk 161 is used for anchoring inside the left atrial appendage, the third disk 163 is used as the sealing disk 120 to block the opening of the left atrial appendage, and the second disk 162 is located near the opening of the left atrial appendage.

实施例15Example 15

图26为本发明的实施例15提供的左心耳封堵消融装置的结构示意图;Fig. 26 is a schematic structural view of the left atrial appendage occlusion ablation device provided by Embodiment 15 of the present invention;

图27为图26中活动件150的结构示意图,图27中为活动件150的第一种结构示意图。FIG. 27 is a schematic structural diagram of the movable member 150 in FIG. 26 , and FIG. 27 is a schematic structural diagram of the first type of movable member 150 .

请参照图26和图27,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于,增加了活动件150,该活动件150用于传输消融能量或采集组织生理信号,且该活动件150能够相对活动地设在密封盘120和锚定盘110上。并且在完成组织消融后,该活动件150可以与密封盘120和锚定盘110分离,并撤出体外,仅将密封盘120和锚定盘110留在体内。Please refer to Fig. 26 and Fig. 27, this embodiment also provides a left atrial appendage blockage ablation device, the main difference between it and the left atrial appendage blockage ablation device provided in embodiment 1 is that a movable part 150 is added, the movable part 150 is used to transmit ablation energy or collect tissue physiological signals, and the movable part 150 can be relatively movably arranged on the sealing disc 120 and the anchoring disc 110 . And after the tissue ablation is completed, the movable part 150 can be separated from the sealing disc 120 and the anchoring disc 110 and withdrawn from the body, leaving only the sealing disc 120 and the anchoring disc 110 in the body.

在本实施例中,左心耳封堵消融装置包括密封盘120、锚定盘110以及活动地设于锚定盘110上的活动件150。In this embodiment, the left atrial appendage blockage ablation device includes a sealing disc 120 , an anchoring disc 110 and a movable member 150 movably arranged on the anchoring disc 110 .

在一些实施例中,密封盘120与锚定盘110之间通过绝缘连接件130连接。活动件150的近端活动地穿过绝缘连接件130内的腔道。活动件150的远端活动地布置于锚定盘110远端或外周侧。可以理解的是,绝缘连接件130也可以用绝缘骨架来代替。In some embodiments, the sealing disc 120 is connected to the anchoring disc 110 through an insulating connector 130 . The proximal end of the movable part 150 moves through the cavity in the insulating connecting part 130 . The distal end of the movable member 150 is movably arranged on the distal end or the outer peripheral side of the anchoring disc 110 . It can be understood that the insulating connector 130 can also be replaced by an insulating frame.

在一些实施例中,活动件150与锚定盘110之间做绝缘处理,因此密封盘120与锚定盘110之间是否绝缘连接并不限定。In some embodiments, the movable part 150 and the anchoring plate 110 are insulated, so whether the sealing plate 120 and the anchoring plate 110 are insulated or not is not limited.

活动件150的全部或部分为导电材料制成。在一些实施例中,活动件150可以作为第二导电部114活动地设于锚定盘110的远端或外周侧。此时,第二导管141可以与活动件150相连并电连接,以为活动件150提供消融能量。All or part of the movable part 150 is made of conductive material. In some embodiments, the movable element 150 can be movably disposed on the distal end or the outer peripheral side of the anchoring disc 110 as the second conductive part 114 . At this time, the second catheter 141 may be connected to the movable part 150 and electrically connected to provide ablation energy for the movable part 150 .

在另一些实施例中,活动件150也可以作为独立于第二导电部114外的第三导电部活动地设于锚定盘110的远端或外周侧。第二导电部114可以是锚定盘110的第一骨架111的部分或全部,也可以是独立于第一骨架111外的第一电极件116。此时,第二导管141可以与第二导电部114电连接,以为第二导电部114提供消融能量;第三导管穿设于第二导管141内,并与活动件150电连接,以为活动件150(即第三导电部)提供消融能量。In some other embodiments, the movable element 150 may also be movably disposed on the distal end or the outer peripheral side of the anchoring disc 110 as a third conductive portion independent of the second conductive portion 114 . The second conductive portion 114 may be part or all of the first frame 111 of the anchoring plate 110 , and may also be the first electrode member 116 independent of the first frame 111 . At this time, the second catheter 141 can be electrically connected to the second conductive part 114 to provide ablation energy for the second conductive part 114; the third catheter is passed through the second catheter 141 and electrically connected to the movable part 150 to serve as 150 (ie the third conductive part) provides ablation energy.

请参照图27,本实施例的活动件150为网盘结构,且其远端沿径向可伸缩。当活动件150在锚定盘110的远端释放时,活动件150沿径向膨胀张开。Please refer to FIG. 27 , the movable part 150 of this embodiment is a network disk structure, and its distal end is stretchable in the radial direction. When the movable part 150 is released at the distal end of the anchoring disk 110, the movable part 150 expands radially.

活动件150可采用由金属丝编织制成的消融盘,或由金属管材切割制成的消融盘。该消融盘的近端收束形成有收束部1501。消融盘为双层网盘结构,即消融盘的近端与远端都设置有成网格状的网盘结构,网盘结构沿径向延伸。The movable part 150 may be an ablation disc made of braided metal wire, or an ablation disc made of cut metal tubing. A converging portion 1501 is formed at the proximal end of the ablation disk. The ablation disk has a double-layer network disk structure, that is, both the proximal end and the distal end of the ablation disk are provided with a grid-shaped network disk structure, and the network disk structure extends radially.

图28为图26中活动件150的第二种结构示意图。FIG. 28 is a second structural schematic diagram of the movable member 150 in FIG. 26 .

请参照图28,在本实施例中的活动件150与图27中的活动件150结构不同。在本实施例中,活动件150包括沿径向依次连接的第一部1511、第二部1512及第三部1513。第一部1511用于连接导线,从而与外部消融信号源电连接。第二部1512由第一部1511沿径向向外延伸。第三部1513由第二部1512的外端弯折并沿径向向内延伸。Please refer to FIG. 28 , the structure of the movable member 150 in this embodiment is different from that of the movable member 150 in FIG. 27 . In this embodiment, the movable element 150 includes a first portion 1511 , a second portion 1512 and a third portion 1513 sequentially connected in a radial direction. The first part 1511 is used for connecting wires, so as to be electrically connected with an external ablation signal source. The second portion 1512 extends radially outward from the first portion 1511 . The third portion 1513 is bent from the outer end of the second portion 1512 and extends radially inward.

可以理解的是,第三部1513可以由第二部1512的外端向上弯折或向下弯折。It can be understood that the third part 1513 can be bent upwards or downwards from the outer end of the second part 1512 .

图29为图26中活动件150的第三种结构示意图。FIG. 29 is a schematic diagram of a third structure of the movable member 150 in FIG. 26 .

请参照图29,在本实施例中的活动件150与图27中的活动件150结构不同。在本实施例中,活动件150整体呈伞骨状结构,并可沿径向伸缩。活动件150可采用金属管材切割制成。Please refer to FIG. 29 , the structure of the movable member 150 in this embodiment is different from that of the movable member 150 in FIG. 27 . In this embodiment, the movable part 150 is in the shape of an umbrella rib as a whole, and can expand and contract in the radial direction. The movable part 150 can be made by cutting a metal pipe.

具体地,活动件150包括多个第一支杆1521和多个第二支杆1522。多个第一支杆1521沿径向向外延伸,且在径向向外的方向上,相邻的第一支杆1521之间的距离逐渐变大。多个第一支杆1521形成由近端至远端逐渐径向外扩的支架结构。多个第二支杆1522围绕设置在多个第一支杆1521的外周,并由远端至近端逐渐弯折延伸。第二支杆1522的远端与第一支杆1521的外端相连。多个第二支杆1522也可用于锚定左心耳的内壁组织。Specifically, the movable member 150 includes a plurality of first struts 1521 and a plurality of second struts 1522 . The plurality of first struts 1521 extend radially outward, and the distance between adjacent first struts 1521 gradually increases in the radially outward direction. The plurality of first struts 1521 form a stent structure that gradually expands radially from the proximal end to the distal end. The plurality of second struts 1522 are disposed around the outer circumference of the plurality of first struts 1521 , and are gradually bent and extended from the distal end to the proximal end. The distal end of the second rod 1522 is connected with the outer end of the first rod 1521 . A plurality of second struts 1522 may also be used to anchor the inner wall tissue of the left atrial appendage.

如图29所示的实施例中,活动件150还包括多个连接于第一支杆1521和第二支杆1522之间的第一连杆1523和第二连杆1524。每一第一支杆1521的远离活动件150轴线的端部均与一第一连杆1523和一第二连杆1524相连,并形成Y字形结构。第一连杆1523远离第一支杆1521的端部与相邻的另一第二连杆1524的远离第一支杆1521的端部相连,并形成第三连接点1525。第二支杆1522的远端与连接于第三连接点1525。第二支杆1522的近端沿径向向内弯折,并逐渐向远端回钩,以避免第二支杆1522刺入左心耳的内壁组织中,减小对组织的损伤。In the embodiment shown in FIG. 29 , the movable member 150 further includes a plurality of first connecting rods 1523 and second connecting rods 1524 connected between the first rod 1521 and the second rod 1522 . The end of each first rod 1521 away from the axis of the movable member 150 is connected with a first connecting rod 1523 and a second connecting rod 1524 to form a Y-shaped structure. The end of the first connecting rod 1523 away from the first pole 1521 is connected to the end of another adjacent second connecting rod 1524 away from the first pole 1521 to form a third connection point 1525 . The distal end of the second rod 1522 is connected to the third connection point 1525 . The proximal end of the second strut 1522 is bent radially inward, and is gradually hooked back toward the distal end, so as to prevent the second strut 1522 from penetrating into the inner wall tissue of the left atrial appendage and reduce damage to the tissue.

活动件150整体呈伞骨状结构,可便于释放和回收。在消融结束时,可通过输送器140中的第二导管141拉动活动件150向近端移动,并收回至第一导管142内。或通过第三导管拉动活动件150向近端移动,并收回至第二导管141内。The movable part 150 is in the shape of an umbrella rib as a whole, which is convenient for release and recovery. At the end of the ablation, the movable member 150 can be pulled by the second catheter 141 in the conveyor 140 to move proximally and retracted into the first catheter 142 . Or the movable part 150 is pulled to move proximally by the third catheter, and is retracted into the second catheter 141 .

图30为图26中活动件150的第四种结构示意图。FIG. 30 is a schematic diagram of a fourth structure of the movable member 150 in FIG. 26 .

请参照图30,在本实施例中的活动件150与图27中的活动件150结构不同。在本实施例中,活动件150整体呈管状结构。具体地,活动件150包括管体153和多个间隔地设置在管体153上的管电极154。Please refer to FIG. 30 , the structure of the movable member 150 in this embodiment is different from that of the movable member 150 in FIG. 27 . In this embodiment, the movable element 150 is in a tubular structure as a whole. Specifically, the movable part 150 includes a tube body 153 and a plurality of tube electrodes 154 disposed on the tube body 153 at intervals.

其中,管体153由近端至远端包括依次连接的轴心段1531、外延段1532和环形段1533。Wherein, the tube body 153 includes an axial section 1531 , an extension section 1532 and a ring section 1533 which are sequentially connected from the proximal end to the distal end.

轴心段1531用于连接消融信号源。在活动件150作为第二导电部114使用时,轴心段1531与第二导管141可拆卸连接或一体连接。在活动件150作为独立于第二导电部114外的第三导电部使用时,轴心段1531与第三导管可拆卸连接或一体连接,并活动地穿设于第二导管141内。The shaft section 1531 is used to connect with an ablation signal source. When the movable member 150 is used as the second conductive part 114 , the shaft section 1531 is detachably connected or integrally connected with the second conduit 141 . When the movable member 150 is used as a third conductive part independent of the second conductive part 114 , the shaft section 1531 is detachably connected or integrally connected with the third conduit, and is movably passed through the second conduit 141 .

外延段1532由轴心段1531的远端沿径向向外延伸。The extension section 1532 extends radially outward from the distal end of the shaft section 1531 .

环形段1533由外延段1532远离轴心段1531的端部环绕轴心段1531的周向呈环状延伸。多个管电极154间隔地布置在外延段1532和环形段1533上。The ring segment 1533 extends in a ring shape around the circumference of the shaft segment 1531 from the end of the extension segment 1532 away from the shaft segment 1531 . A plurality of tube electrodes 154 are arranged at intervals on the extension section 1532 and the ring section 1533 .

在一些实施例中,多个管电极154中,相邻的管电极154可以连接相同的消融电信号;也可以连接不同的消融电信号,如依次交替连接正、负消融信号源。In some embodiments, among the plurality of tube electrodes 154, adjacent tube electrodes 154 may be connected to the same ablation electrical signal; or may be connected to different ablation electrical signals, such as alternately connecting positive and negative ablation signal sources sequentially.

在另一些实施例中,活动件150还可以用于采集左心耳内部的电生理信号,相应地,管电极154中可以用于标测。In some other embodiments, the movable part 150 can also be used to collect electrophysiological signals inside the left atrial appendage, and correspondingly, the tube electrodes 154 can be used for mapping.

图31为图26中活动件150的第五种结构示意图。FIG. 31 is a schematic diagram of a fifth structure of the movable member 150 in FIG. 26 .

请参照图31,在本实施例中的活动件150与图30中的活动件150结构大致相同,主要区别在于,环形段1533的结构不同。在本实施例中,环形段1533整体环绕轴心段1531的周向呈螺旋状环绕,其可以环绕轴心段1531呈平面螺旋结构,也可以沿轴心段1531的轴向逐渐螺旋环绕呈柱状或锥状。Please refer to FIG. 31 , the structure of the movable member 150 in this embodiment is substantially the same as that of the movable member 150 in FIG. 30 , the main difference is that the structure of the annular segment 1533 is different. In this embodiment, the annular segment 1533 surrounds the axial segment 1531 in a spiral shape as a whole, and it can surround the axial segment 1531 in a plane spiral structure, or it can gradually spiral in the axial direction of the axial segment 1531 to form a columnar shape. or cone.

实施例16Example 16

图32为本发明的实施例16提供的左心耳封堵消融装置的结构示意图。Fig. 32 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 16 of the present invention.

请参阅图32,并结合图19和图20,本实施例也提供了一种左心耳封堵消融装置,其与实施例1提供的左心耳封堵消融装置的主要区别在于增加了活动件150。Please refer to Fig. 32, and in combination with Fig. 19 and Fig. 20, this embodiment also provides a left atrial appendage blockage ablation device, which is mainly different from the left atrial appendage blockage ablation device provided in Embodiment 1 in that the movable part 150 is added .

在一些实施例中,密封盘120与锚定盘110之间通过绝缘连接件130连接。活动件150的近端活动地穿过绝缘连接件130内的腔道。活动件150的远端活动地布置于锚定盘110远端或外周侧。可以理解的是,绝缘连接件130也可以用绝缘骨架来代替。In some embodiments, the sealing disc 120 is connected to the anchoring disc 110 through an insulating connector 130 . The proximal end of the movable part 150 moves through the cavity in the insulating connecting part 130 . The distal end of the movable member 150 is movably arranged on the distal end or the outer peripheral side of the anchoring disc 110 . It can be understood that the insulating connector 130 can also be replaced by an insulating frame.

在一些实施例中,活动件150与锚定盘110之间做绝缘处理,因此密封盘120与锚定盘110之间是否绝缘连接并不限定。In some embodiments, the movable part 150 and the anchoring plate 110 are insulated, so whether the sealing plate 120 and the anchoring plate 110 are insulated or not is not limited.

在本实施例中,活动件150的远端活动地布置于锚定盘110内部或远端。In this embodiment, the distal end of the movable member 150 is movably arranged inside or at the distal end of the anchoring disc 110 .

锚定盘110的第一骨架111的远端开口。活动件150可经该开口,在第一骨架111的内部和远端的外部之间进行来回移动。The distal end of the first skeleton 111 of the anchoring disc 110 is open. The movable part 150 can move back and forth between the inside of the first frame 111 and the outside of the distal end through the opening.

在一些实施例中,活动件150全部或部分为导电材料制成。活动件150可以作为第二导电部114活动地设于锚定盘110的内部或远端。此时,第二导电部114与第一导电部122(即密封盘120)共同进行消融。In some embodiments, all or part of the movable part 150 is made of conductive material. The movable part 150 can be movably disposed inside or at the distal end of the anchoring plate 110 as the second conductive part 114 . At this time, the second conductive part 114 and the first conductive part 122 (ie, the sealing disc 120 ) are jointly ablated.

在另一些实施例中,第二导电部114可以是第一骨架111的部分或全部,而活动件150作为独立于第二导电部114之外的第三导电部,并与第二导电部114电隔离。此时,第二导电部114、第一导电部122及第三导电部共同进行消融。In some other embodiments, the second conductive part 114 may be part or all of the first frame 111, and the movable part 150 is a third conductive part independent of the second conductive part 114, and is connected with the second conductive part 114. Galvanic isolation. At this time, the second conductive part 114 , the first conductive part 122 and the third conductive part are ablated together.

可以理解的是,本实施例的活动件150可以采用图27至图31中的任一一种活动件150的结构。It can be understood that, the movable member 150 of this embodiment can adopt any one of the movable member 150 structures in FIG. 27 to FIG. 31 .

实施例17Example 17

图33为本发明的实施例17提供的左心耳封堵消融装置的结构示意图。Fig. 33 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 17 of the present invention.

请参阅图33,并结合图32,本实施例也提供了一种左心耳封堵消融装置,其与实施例16提供的左心耳封堵消融装置的结构大致相同,主要区别在于增加了第一电极件116。Please refer to Fig. 33, and in combination with Fig. 32, this embodiment also provides a left atrial appendage blockage ablation device, which has roughly the same structure as the left atrial appendage blockage ablation device provided in Embodiment 16, the main difference is that the first electrode piece 116 .

在本实施例中,第一电极件116与活动件150电隔离,即第一电极件116与活动件150之间作绝缘处理,具体可参照前述的绝缘处理方式。第一电极件116与活动件150分别可作为第二导电部114和第三导电部,并与第一导电部122配合共同进行消融。In this embodiment, the first electrode member 116 is electrically isolated from the movable member 150 , that is, an insulation treatment is performed between the first electrode member 116 and the movable member 150 , and details may refer to the aforementioned insulation treatment method. The first electrode member 116 and the movable member 150 can serve as the second conductive part 114 and the third conductive part respectively, and cooperate with the first conductive part 122 to perform ablation.

实施例18Example 18

图34为本发明的实施例18提供的左心耳封堵消融装置的结构示意图。Fig. 34 is a schematic structural view of the left atrial appendage blockage ablation device provided by Embodiment 18 of the present invention.

请参阅图34,并结合图26,本实施例也提供了一种左心耳封堵消融装置,其与实施例15提供的左心耳封堵消融装置的结构大致相同,主要区别在于增加了电极丝作为第一电极件116。Please refer to Fig. 34, combined with Fig. 26, this embodiment also provides a left atrial appendage blockage ablation device, which has roughly the same structure as the left atrial appendage blockage ablation device provided in Example 15, the main difference is that the electrode wire is added As the first electrode member 116 .

在本实施例中,电极丝缠绕在第一骨架111上,形成第一电极件116。该电极丝绕制形成的第一电极件116可以作为第二导电部114。In this embodiment, the electrode wire is wound on the first frame 111 to form the first electrode member 116 . The first electrode member 116 formed by winding the electrode wire can be used as the second conductive part 114 .

活动件150的全部或部分为导电材料制成。活动件150可以作为第三导电部,并与第二导电部114一起进行消融。All or part of the movable part 150 is made of conductive material. The movable part 150 can serve as the third conductive part, and ablate together with the second conductive part 114 .

需要说明的是,本申请以上实施方式中的具体技术方案可以相互适用。It should be noted that the specific technical solutions in the above implementation manners of the present application may be applicable to each other.

虽然已参照几个典型实施方式描述了本发明,但应当理解,所用的术语是说明和示例性、而非限制性的术语。由于本发明能够以多种形式具体实施而不脱离发明的精神或实质,所以应当理解,上述实施方式不限于任何前述的细节,而应在随附权利要求所限定的精神和范围内广泛地解释,因此落入权利要求或其等效范围内的全部变化和改型都应为随附权利要求所涵盖。While this invention has been described with reference to several exemplary embodiments, it is understood that the terms which have been used are words of description and illustration, rather than of limitation. Since the present invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above-described embodiments are not limited to any of the foregoing details, but should be construed broadly within the spirit and scope of the appended claims. , all changes and modifications falling within the scope of the claims or their equivalents shall be covered by the appended claims.

Claims (24)

1. A left atrial appendage occlusion ablation device, comprising:
the anchoring disc is of a radial telescopic support structure; and
the sealing disc is of a radial telescopic support structure and is arranged at the near end of the anchoring disc; the sealing disc is made of a conductive material, and the whole sealing disc is used as a first conductive part for transmitting ablation energy or collecting tissue physiological signals.
2. The left atrial appendage occlusion ablation device of claim 1, further comprising a second conductive portion for transmitting ablation energy or collecting tissue physiological signals, respectively; the second conductive part is arranged on the anchoring disc; the sealing disk is electrically isolated from the second electrically conductive portion.
3. The left atrial appendage occlusion ablation device of claim 2, further comprising an insulating connector disposed between the anchor disk and the sealing disk;
the insulating connecting piece extends along the axial direction, the far end of the insulating connecting piece is connected with the anchoring disc, and the near end of the insulating connecting piece is connected with the sealing disc; the insulating connector is configured to electrically isolate the second conductive portion from the seal land.
4. The left atrial appendage occlusion ablation device of claim 3, wherein a distal end of the insulating connector is provided with a first conductive connection that is electrically connected to the second conductive portion;
there is at least partial axial section insulation on the insulating connector between the first conductive connection and the sealing disk to electrically isolate the first conductive connection from the sealing disk.
5. The left atrial appendage occlusion ablation device of claim 4, wherein the insulating connector comprises a first connector and a second connector connected in series along an axial direction; the second connector is located at the proximal end of the first connector;
the anchoring disc is connected to the first connecting piece; the sealing disc is connected with the second connecting piece; the first conductive connecting part is arranged on the first connecting piece;
the insulated axial section is formed on the first connector, or on the second connector, or between the first connector and the second connector.
6. The left atrial appendage occlusion ablation device of claim 5, wherein the insulating connector further comprises a third connector disposed between the first connector and the second connector; the insulated axial section is formed on the third connector.
7. The left atrial appendage occlusion ablation device of claim 5, wherein a plurality of the third connectors are provided, and the plurality of third connectors are axially connected in sequence; wherein the third connector at the most distal end is connected to the first connector, the third connector at the most proximal end is connected to the second connector, and the insulated axial section is formed at least on one of the third connectors.
8. The left atrial appendage occlusion ablation device of claim 5, wherein a first installation space is formed in the first connector, and one end of the anchoring disk is connected in a constrained manner in the first installation space;
and/or a second mounting space is formed on the second connecting piece, and the far end of the sealing disc is converged in the second mounting space.
9. A left atrial appendage occlusion ablation device as in claim 6, wherein the first conductive connection is removably connected to the first connector.
10. The left atrial appendage occlusion ablation device of claim 9, wherein the insulating connector further comprises a fourth connector disposed between the first connector and the first conductive connection;
the fourth connector has the insulated axial section formed thereon to electrically isolate the first conductive connection from the first connector;
the third connector has the insulated axial section formed thereon to electrically isolate the first connector from the third connector.
11. A left atrial appendage occlusion ablation device as in claim 3, wherein the anchoring disk comprises a first backbone; the first framework is a radially telescopic support structure; the first framework is made of metal wires in a weaving mode or metal pipes in a cutting mode;
the far end of the insulating connecting piece is connected with the first framework;
the second conductive part is part or all of the first framework, or the second conductive part is an electrode element arranged on the peripheral wall of the first framework.
12. The left atrial appendage occlusion ablation device of claim 1, wherein the anchor disk comprises a support portion and an anchor portion;
the supporting parts are arranged in plurality and surround the axis of the anchoring disc; one end of the supporting part is connected with the sealing disc, and the other end of the supporting part is bent and extended outwards gradually along the radial direction;
the anchoring parts are arranged in a plurality and surround the periphery of the supporting part; the anchoring part is bent and extended towards the proximal end from the end part of the supporting part far away from the axis of the anchoring disc.
13. A left atrial appendage occlusion ablation device as in claim 12, wherein each support portion comprises a support rod, a first branch and a second branch;
one end of the supporting rod is connected to the sealing disc, and the other end of the supporting rod is bent and extended outwards gradually along the radial direction;
one end of each of the first branch and the second branch is connected to one end, far away from the axis of the anchoring disc, of the corresponding supporting rod; one end of the first branch, which is far away from the supporting rod, is connected with one end of the second branch, which is far away from the supporting rod, of the adjacent supporting part, and a connecting point is formed; the anchoring portion extends from the connection point toward the proximal end.
14. A left atrial appendage closure ablation device as in claim 13, wherein the end of the anchoring portion distal from the connection point is bent toward the axis of the anchoring disk.
15. A left atrial appendage occlusion ablation device as in claim 14, wherein an end of the anchor portion distal from the connection point is crimped to an end of another adjacent anchor portion distal from the connection point.
16. The left atrial appendage occlusion ablation device of claim 4, wherein the insulating connector has an axially extending channel formed therein, the channel extending from a proximal end of the insulating connector to the first conductive connection.
17. The left atrial appendage occlusion ablation device of claim 2, further comprising a movable member that movably passes through the anchor disk and the sealing disk; the movable part is used for transmitting ablation energy or collecting tissue physiological signals, and the movable part serves as the second conductive part or a third conductive part electrically isolated from the second conductive part.
18. The left atrial appendage occlusion ablation device of claim 17, wherein a distal end of the anchor disk is provided with an opening;
the distal end of the moveable member is capable of moving through the opening from the interior of the anchor plate to the distal side of the anchor plate or from the distal side of the anchor plate to the interior of the anchor plate.
19. The left atrial appendage closure ablation device of claim 17, wherein the distal end of the moveable member is a radially retractable structure, the distal end of the moveable member being releasable and in a radially expanded state.
20. The left atrial appendage occlusion ablation device of claim 2, wherein a second conductive connection is formed at a proximal end of the sealing disk and is configured to receive ablation energy or transmit tissue physiological signals; the second conductive connecting portion is cylindrical, and a through hole extending in the axial direction is formed in the second conductive connecting portion.
21. A left atrial appendage occlusion ablation device as in claim 20, wherein the sealing disk comprises a second skeleton, the second skeleton is a radially retractable support structure, and the second skeleton is woven from metal wires or cut from metal tubing; and the near end of the second framework is connected to the second conductive connecting part in a converging manner.
22. A left atrial appendage closure ablation device as in claim 21, wherein the outer peripheral wall of the distal end of the second backbone is provided with an insulating membrane that is blocked between the distal end of the second backbone and the proximal end of the anchor disk.
23. A left atrial appendage occlusion ablation device of any one of claims 2-22; the left atrial appendage occlusion ablation device is characterized by further comprising an outer tube, a first catheter and a second catheter;
the outer pipe is tubular, and the distal end of the outer pipe can accommodate the anchoring disc and the sealing disc in a radial contraction state;
the first guide pipe is movably arranged in the outer pipe in a penetrating way and can move relative to the outer pipe along the axial direction; the distal end of the first conduit is in electrically conductive connection with the sealing disk;
the second guide pipe is movably arranged in the first guide pipe in a penetrating way and can move relative to the first guide pipe along the axial direction; the distal end of the second conduit is movably disposed through the sealing disk and is in electrically conductive communication with the second electrically conductive portion.
24. A left atrial appendage occlusion ablation device of any one of claims 17-19; when the movable piece is used as a third conductive part electrically isolated from the second conductive part, the left atrial appendage occlusion ablation device further comprises an outer tube, a first catheter, a second catheter and a third catheter;
the outer tube is tubular, and the distal end of the outer tube can accommodate the anchoring disc and the sealing disc in a radial contraction state;
the first guide pipe is movably arranged in the outer pipe in a penetrating way and can move relative to the outer pipe along the axial direction; the distal end of the first conduit is in conductive communication with the sealing disk to transmit ablation energy to the sealing disk;
the second guide pipe is movably arranged in the first guide pipe in a penetrating way and can move relative to the first guide pipe along the axial direction; the distal end of the second conduit movably passes through the sealing disc and is electrically connected with the second conductive part;
the third guide pipe is movably arranged in the second guide pipe in a penetrating way and can move relative to the second guide pipe along the axial direction; the distal end of the third catheter is electrically connected to the third conductive portion.
CN202110790616.3A 2021-06-08 2021-07-13 Left atrial appendage blockage ablation device Pending CN115444542A (en)

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