WO2022121647A1 - Surgical suture cutting device and valve repair method - Google Patents

Abstract

A surgical suture cutting device, comprising a suture cutting component (100) and a fitting (200). The suture cutting component (100) comprises a fixing member (110) and a blade (120) connected to the fixing member (110). The fitting member (200) comprises a base portion (220) and a guide portion (210). The base portion (220) is provided with a suture cutting matching surface (221). The fixing member (110) is movably sleeved on the guide portion (210). The blade (120) has a cutting edge. A surgical suture (800) is at least partially located between the cutting edge and the suture cutting matching surface (221). The fixing member (110) moves relative to the guide portion (210) to drive the cutting edge of the blade (120) to abut against the suture cutting matching surface (221), and the surgical suture (800) at least partially abuts against the suture cutting matching surface (221), and is cut off by the cutting edge.

Description

医用切线装置和修复瓣膜的方法Medical tangent device and method for repairing valve

相关申请的引用Citations to Related Applications

本公开要求于2020年12月11日向中华人民共和国国家知识产权局提交的申请号为202011459556.9、名称为“医用切线装置”的发明专利申请，以及于2020年12月11日向中华人民共和国国家知识产权局提交的申请号为202022998275.2、名称为“医用切线装置”的实用新型专利申请的全部权益，并通过引用的方式将其全部内容并入本文。This disclosure requires an invention patent application with the application number 202011459556.9 and the title "Medical thread tangent device" filed with the State Intellectual Property Office of the People's Republic of China on December 11, 2020, and a patent application filed with the State Intellectual Property Office of the People's Republic of China on December 11, 2020 The entire rights and interests of the utility model patent application entitled "Medical Thread Tangent Device" filed by the Bureau with application number 202022998275.2, and the entire contents of which are incorporated herein by reference.

领域field

本公开大体上涉及医疗器械技术领域，更具体地，涉及医用切线装置和修复瓣膜的方法。The present disclosure generally relates to the technical field of medical devices, and more particularly, to a medical tangential device and a method of repairing a valve.

背景background

在传统外科手术中经常需要对医用线(如缝合线、用作人工腱索的修复线、对瓣膜做缘对缘修复的修复线等)进行切断，通常在开刀直视条件下，由医生手动切线。In traditional surgical operations, it is often necessary to cut medical threads (such as sutures, repair threads used as artificial chordae tendineae, repair threads for edge-to-edge repair of valves, etc.) Tangent.

随着技术的进步，各种微创手术及介入手术日益普遍，例如腔镜下手术、经导管介入手术等，这类手术只需在患者身体上切开较小的操作窗口，由此将内窥镜或介入导管等器械伸入患者体内，到达预定位点进行治疗，如需对患者体内的医用线进行切线操作，需要操作者通过所述较小的操作窗口，在患者体外进行远程操作来进行切线。With the advancement of technology, various minimally invasive surgeries and interventional surgeries are becoming more and more common, such as laparoscopic surgery, transcatheter interventional surgeries, etc. These surgeries only need to cut a small operating window on the patient's body, so that the internal Instruments such as a speculum or an interventional catheter are inserted into the patient's body to reach a predetermined site for treatment. If the tangential operation of the medical thread in the patient's body is required, the operator needs to perform a remote operation outside the patient's body through the small operation window. Make a tangent.

概述Overview

一方面，本公开涉及的医用切线装置包括切线组件以及配止件。In one aspect, the medical thread cutting device involved in the present disclosure includes a thread cutting assembly and a fitting.

所述切线组件包括固定件及连接于所述固定件的刀片。所述配止件包括基部和导引部。The thread cutting assembly includes a fixing piece and a blade connected to the fixing piece. The fitting includes a base and a guide.

其中，所述基部设置有切线配合面，所述固定件活动套设于所述导引部上，所述刀片具有刃口，医用线至少部分位于所述刃口与所述切线配合面之间；所述固定件相对于所述导引部运动以带动所述刀片的刃口抵压所述切线配合面时，所述医用线至少部分抵靠所述切线配合面并被所述刃口切断。Wherein, the base is provided with a tangent mating surface, the fixing member is movably sleeved on the guide portion, the blade has a cutting edge, and the medical wire is at least partially located between the cutting edge and the tangent mating surface ; When the fixing member moves relative to the guide portion to drive the cutting edge of the blade to press against the tangent matching surface, the medical wire at least partially abuts the tangential matching surface and is cut by the cutting edge .

在某些实施方案中，所述导引部开设有穿通所述导引部远端面的过线孔及与所述过线孔贯通的侧孔，所述医用线自所述过线孔穿入，自所述侧孔穿出，且所述医用线自所述侧孔穿出的部分位于所述刃口与所述切线配合面之间。In some embodiments, the guide portion is provided with a wire hole passing through the distal surface of the guide portion and a side hole passing through the wire hole, and the medical wire is passed through the wire hole into and out from the side hole, and the part of the medical wire that goes out from the side hole is located between the cutting edge and the tangent line mating surface.

在某些实施方案中，所述刀片的刃口宽度为a，所述侧孔的宽度为b，所述医用线的股数为n，所述医用线的直径为d；In certain embodiments, the width of the cutting edge of the blade is a, the width of the side hole is b, the number of strands of the medical wire is n, and the diameter of the medical wire is d;

其中，a≥b且b≥n×(πd/2)。where a≥b and b≥n×(πd/2).

在某些实施方案中，所述固定件设置有沿轴向延伸的内腔， 所述导引部活动穿设于所述固定件的内腔内。In some embodiments, the fixing member is provided with an inner cavity extending in the axial direction, and the guide portion is movably passed through the inner cavity of the fixing member.

在某些实施方案中，所述切线组件还包括至少一个驱动丝组，所述驱动丝组的远端固定连接所述固定件，所述驱动丝组运动带动所述固定件相对于所述导引部运动。In some embodiments, the thread cutting assembly further includes at least one driving wire group, the distal end of the driving wire group is fixedly connected to the fixing member, and the driving wire group moves to drive the fixing member relative to the guide wire Lead movement.

在某些实施方案中，所述切线配合面位于所述固定件的近侧，所述驱动丝组沿轴向向近端运动以拉动所述固定件相对于所述导引部运动。In certain embodiments, the tangential mating surface is located proximal of the fixture, and the drive wire set moves proximally in the axial direction to pull the fixture relative to the guide.

在某些实施方案中，所述基部沿轴向方向开设有导向槽，所述驱动丝组与所述导向槽间隙配合，以使所述驱动丝组沿所述导向槽轴向滑动。In some embodiments, the base is provided with a guide groove along the axial direction, and the driving wire group is in clearance fit with the guide groove, so that the driving wire group slides axially along the guide groove.

在某些实施方案中，所述驱动丝组设置有两个，两个所述驱动丝组关于所述固定件的轴向对称。In some embodiments, there are two sets of driving wires, and the two sets of driving wires are symmetrical with respect to the axial direction of the fixing member.

在某些实施方案中，所述固定件与所述导引部轴向滑动配合，所述导引部与所述固定件之间设有至少一对相互适配的导滑面。In some embodiments, the fixing member is axially slidably fitted with the guide portion, and at least a pair of mutually adapted guide sliding surfaces are provided between the guide portion and the fixing member.

在某些实施方案中，所述导引部自所述基部的远端沿轴向延伸，所述切线配合面设置于所述基部的远端，所述切线配合面为围绕所述导引部设置的概呈圆环形的面。In certain embodiments, the guide portion extends axially from the distal end of the base portion, the tangential mating surface is disposed at the distal end of the base portion, and the tangential mating surface surrounds the guide portion Sets the roughly circular face.

在某些实施方案中，所述导引部自所述基部的远端沿轴向延伸，所述切线配合面设置于所述基部的远端，所述切线配合面的底端与所述基部的中轴线平齐或靠近，所述切线配合面与所述基部的外周面相交。In certain embodiments, the guide portion extends axially from the distal end of the base portion, the tangential mating surface is disposed at the distal end of the base portion, and the bottom end of the tangential mating surface is connected to the base portion. The central axis of the tangent line is flush with or close to, and the tangent mating surface intersects with the outer peripheral surface of the base.

在某些实施方案中，所述基部的远端还连接有轴向延伸段，所述轴向延伸段遮盖所述导引部，所述切线组件位于所述轴向延伸段与所述导引部之间。In some embodiments, the distal end of the base is further connected with an axially extending section, the axially extending section covers the guide section, and the tangent component is located between the axially extending section and the guide between the departments.

在某些实施方案中，所述固定件与所述导引部绕所述导引部的轴向转动配合，所述基部绕所述导引部的轴向延伸设置，所述切线配合面凸出于所述导引部的外周面并沿所述导引部的轴向延伸。In some embodiments, the fixing member and the guide portion are rotated in an axial direction around the guide portion, the base portion is arranged around the axial extension of the guide portion, and the tangential mating surface is convex Out of the outer peripheral surface of the guide portion and extending along the axial direction of the guide portion.

在某些实施方案中，所述的医用切线装置还包括柔性内芯及外支撑管组件；In certain embodiments, the medical thread cutting device further comprises a flexible inner core and an outer support tube assembly;

其中，所述柔性内芯的远端连接所述固定件，所述柔性内芯、所述切线组件及所述配止件容置于所述外支撑管组件内。Wherein, the distal end of the flexible inner core is connected to the fixing piece, and the flexible inner core, the tangent component and the matching piece are accommodated in the outer support tube component.

在某些实施方案中，所述外支撑管组件包括：In certain embodiments, the outer support tube assembly includes:

套筒，所述套筒上开设有进线孔及出线孔，所述切线组件与所述配止件容置于所述套筒内，所述配止件与所述套筒固定连接；以及a sleeve, the sleeve is provided with a wire inlet hole and a wire outlet hole, the wire tangent component and the matching piece are accommodated in the sleeve, and the matching piece is fixedly connected to the sleeve; and

柔性外管，所述柔性外管的远端固定连接所述套筒的近端，所述柔性内芯活动穿设于所述柔性外管内。A flexible outer tube, the distal end of the flexible outer tube is fixedly connected to the proximal end of the sleeve, and the flexible inner core is movably penetrated in the flexible outer tube.

在某些实施方案中，所述医用切线装置还包括手柄；In certain embodiments, the medical tangent device further comprises a handle;

其中，所述柔性外管的近端固定连接至所述手柄的远端，所述手柄上设有操控件，所述操控件连接所述柔性内芯的近端，以控制所述柔性内芯沿轴向移动或绕轴向转动。Wherein, the proximal end of the flexible outer tube is fixedly connected to the distal end of the handle, the handle is provided with a manipulation member, and the manipulation member is connected to the proximal end of the flexible inner core to control the flexible inner core Move or rotate in the axial direction.

在某些实施方案中，所述手柄内还设有弹性件，所述弹性件被 压缩于所述操控件与所述手柄的内壁之间，以使所述操控件复位。In some embodiments, an elastic member is further provided in the handle, and the elastic member is compressed between the manipulation member and the inner wall of the handle, so as to reset the manipulation member.

另一方面，本公开涉及修复瓣膜的方法，其包括：In another aspect, the present disclosure relates to a method of repairing a valve, comprising:

在需要所述方法的个体外把已经植入在瓣膜瓣叶上且经一锁钉固定的多根医用线穿过权利要求1至17中任一权利要求所述的医用切线装置，使得所述多根医用线至少部分位于所述医用切线装置的刃口与所述切线配合面之间；A plurality of medical wires, which have been implanted on the valve leaflets and secured by a locking staple, are passed through the medical tangential device of any one of claims 1 to 17 outside the individual in need of the method, such that the A plurality of medical wires are at least partially located between the cutting edge of the medical wire cutting device and the cutting wire mating surface;

顺着所述医用线的引导，将所述医用切线装置的远端经心脏介入路径向所述瓣膜的瓣叶及所述锁钉移动靠近，直至所述医用切线装置的所述远端到达预定位置；Following the guidance of the medical wire, the distal end of the medical thread cutting device is moved closer to the valve leaflet and the locking pin through the cardiac intervention path, until the distal end of the medical thread cutting device reaches a predetermined distance. Location;

带动刀片沿轴向向近端移动，把全部所述医用线压在切线配合面上，然后切断所述医用线；以及Drive the blade to move proximally in the axial direction, press all the medical wires on the tangent mating surface, and then cut the medical wires; and

将所述医用切线装置与多余的所述医用线撤出所述个体外。The medical thread cutting device and the excess medical thread are withdrawn from the outside of the individual.

在某些实施方案中，所述个体为人。In certain embodiments, the individual is a human.

在某些实施方案中，瓣膜包括但不限于二尖瓣和三尖瓣。In certain embodiments, valves include, but are not limited to, mitral and tricuspid valves.

本公开涉及的医用切线装置的某些实施方案易于切断医用线，并避免了切线过程中刀片与切线配合面之间出现挤线的情况。在某些实施方案中，本公开的医用切线装置在切线过程中，固定件相对于配止件的导引部运动，从而带动刀片的刃口抵压配止件的切线配合面，所述切线配合面为医用线提供抵靠，为刀片的刃口提供着力点，使得医用线易于被切断；同时，由于刀片的刃口与切线配合面之间是相互抵压的关系，不会产生类似于剪刀那样的相互交错关系，从而刀片与切线配合面之间也不存在挤线的异常情况，保证医用切线装置可以顺利撤回，避免了因挤线拉扯器官组织的风险。Certain embodiments of the medical thread cutting device involved in the present disclosure are easy to cut the medical thread, and avoid the situation of thread squeezing between the blade and the thread cutting mating surface during the thread cutting process. In certain embodiments, during the thread cutting process of the medical thread cutting device of the present disclosure, the fixing member moves relative to the guide portion of the fitting member, thereby driving the cutting edge of the blade to press against the tangent mating surface of the fitting member. The mating surface provides abutment for the medical wire, and provides a force point for the cutting edge of the blade, so that the medical wire is easy to be cut off; at the same time, because the cutting edge of the blade and the tangent mating surface are pressed against each other, there will be no similar Due to the staggered relationship like scissors, there is no abnormal situation of thread extrusion between the blade and the tangent mating surface, which ensures that the medical thread tangent device can be withdrawn smoothly and avoids the risk of pulling the organ tissue due to the extrusion thread.

附图的简要说明Brief Description of Drawings

此处的附图被并入说明书中并构成本说明书的一部分，示出了符合本公开的实施例，并与说明书一起用于解释本公开的原理。The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the disclosure and together with the description serve to explain the principles of the disclosure.

为了更清楚地说明本公开的技术方案，下面将对本公开中所需要使用的附图作简单地介绍，显而易见地，对于本领域普通技术人员而言，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。In order to illustrate the technical solutions of the present disclosure more clearly, the accompanying drawings required in the present disclosure will be briefly introduced below. Obviously, for those of ordinary skill in the art, without any creative effort, the Additional drawings can be obtained from these drawings.

附图中：In the attached picture:

图1为本公开实施例一的医用切线装置的整体结构示意图；FIG. 1 is a schematic diagram of the overall structure of the medical thread cutting device according to the first embodiment of the disclosure;

图2为显示本公开实施例一的医用切线装置的远端的结构及医用线走线的剖视示意图；2 is a schematic cross-sectional view showing the structure of the distal end of the medical thread cutting device and the routing of the medical thread according to the first embodiment of the present disclosure;

图3为显示本公开实施例一的医用切线装置的远端的结构及切断医用线时的剖视示图；3 is a cross-sectional view showing the structure of the distal end of the medical thread cutting device according to the first embodiment of the present disclosure and when the medical thread is cut;

图4为本公开实施例一中切线组件与配止件配合的立体结构示意图；FIG. 4 is a schematic three-dimensional structural diagram of the matching of the tangent component and the stopper in the first embodiment of the present disclosure;

图5为图4中切线组件与配止件的俯视结构示意图；FIG. 5 is a schematic top view of the tangent component and the fitting in FIG. 4;

图6为本公开实施例一中切线组件与驱动丝组的连接示意图；6 is a schematic diagram of the connection between the tangent wire assembly and the driving wire assembly in the first embodiment of the disclosure;

图7为本公开实施例一中切线组件的立体结构示意图；FIG. 7 is a schematic three-dimensional structural diagram of the tangent component in the first embodiment of the disclosure;

图8为本公开实施例一中配止件的立体结构示意图；FIG. 8 is a schematic three-dimensional structural diagram of a fitting in Embodiment 1 of the present disclosure;

图9为本公开实施例一中手柄内立体结构的示意图；9 is a schematic diagram of the three-dimensional structure in the handle according to the first embodiment of the disclosure;

图10为本公开实施例一中外支撑管组件与外管固定件的连接示意图；10 is a schematic diagram of the connection between the middle and outer support tube assemblies and the outer tube fixing member according to the first embodiment of the disclosure;

图11为本公开实施例一中柔性内管与内管固定件的连接示意图；11 is a schematic diagram of the connection between the flexible inner tube and the inner tube fixing member in the first embodiment of the disclosure;

图12为显示本公开实施例二的医用切线装置的远端的结构及医用线走线的剖视示意图；12 is a schematic cross-sectional view showing the structure of the distal end of the medical thread cutting device and the routing of the medical thread according to the second embodiment of the present disclosure;

图13为显示本公开实施例二的医用切线装置的远端的结构及切断医用线时的剖视示意图；13 is a schematic cross-sectional view showing the structure of the distal end of the medical thread cutting device according to the second embodiment of the present disclosure and when the medical thread is cut;

图14为本公开实施例二中切线组件与配止件配合的立体结构示意图；14 is a schematic three-dimensional structural diagram of the cooperation between the tangent component and the stopper in the second embodiment of the disclosure;

图15为本公开实施例二中配止件的立体结构示意图；FIG. 15 is a schematic three-dimensional structure diagram of a fitting in Embodiment 2 of the present disclosure;

图16为本公开实施例二中切线组件与驱动丝组配合的立体结构示意图；16 is a schematic three-dimensional structural diagram of the coordination of the tangent component and the driving wire set in the second embodiment of the disclosure;

图17为本公开的医用切线装置中的第一种刀片结构的示意图；17 is a schematic diagram of a first blade structure in the disclosed medical thread cutting device;

图18为本公开的医用切线装置中的第二种刀片的结构示意图；18 is a schematic structural diagram of a second type of blade in the disclosed medical thread cutting device;

图19为本公开的医用切线装置中的第三种刀片的结构示意图；19 is a schematic structural diagram of a third type of blade in the disclosed medical thread cutting device;

图20为本公开实施例三的医用切线装置中切线组件与配止件配合的立体结构示意图；20 is a schematic three-dimensional structural diagram of the coordination of the thread cutting assembly and the fitting in the medical thread cutting device according to the third embodiment of the disclosure;

图21为显示本公开实施例三的医用切线装置的远端结构及医用线走线的立体示意图；并且FIG. 21 is a schematic perspective view showing the distal end structure of the medical thread cutting device and the routing of the medical thread according to the third embodiment of the present disclosure; and

图22为显示本公开实施例三的医用切线装置的远端结构及切断医用线时的立体示意图。22 is a perspective view showing the distal end structure of the medical thread cutting device according to the third embodiment of the present disclosure and the time when the medical thread is cut.

详述detail

为了对本公开的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本公开的具体实施方式。以下描述中，需要理解的是，“前”、“后”、“上”、“下”、“左”、“右”、“纵”、“横”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“头”、“尾”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、以特定的方位构造和操作，仅是为了便于描述本技术方案，而不是指示所指的装置或元件必须具有特定的方位，因此不能理解为对本公开的限制。In order to have a clearer understanding of the technical features, purposes and effects of the present disclosure, specific embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. In the following description, it should be understood that "front", "rear", "upper", "lower", "left", "right", "vertical", "horizontal", "vertical", "horizontal", The orientation or positional relationship indicated by "top", "bottom", "inner", "outer", "head", "tail", etc. is constructed and operated in a specific orientation based on the orientation or positional relationship shown in the drawings, It is only for the convenience of describing the technical solution, rather than indicating that the referred device or element must have a specific orientation, so it should not be construed as a limitation of the present disclosure.

还需要说明的是，除非另有明确的规定和限定，“安装”、“相连”、“连接”、“固定”、“设置”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；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或两个元件的相互作用关系。当一个元件被称为在另一元件“上”或“下”时，元件能够“直接地”或“间接地”位于另一元件之上，或者也可能存在一个或更多个居间元件。术语“第一”、“第二”、“第三”等仅是为了便于描述本技术方案，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量，由此，限定有“第一”、“第二”、“第三”等的特征可以 明示或者隐含地包括一个或者更多个特征。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本公开中的具体含义。It should also be noted that, unless otherwise expressly specified and limited, terms such as "installation", "connection", "connection", "fixation" and "setup" should be understood in a broad sense, for example, it may be a fixed connection, or a It can be a detachable connection or integrated; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal communication between the two elements or the interaction relationship between the two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element, or one or more intervening elements may also be present. The terms "first", "second", "third", etc. are only for the convenience of describing the technical solution, and should not be understood as indicating or implying relative importance or implying the number of indicated technical features, thus, Features defined as "first", "second", "third", etc., may expressly or implicitly include one or more of the features. For those of ordinary skill in the art, the specific meanings of the above terms in the present disclosure can be understood according to specific situations.

以下描述中，为了说明而不是为了限定，提出了诸如特定***结构、技术之类的具体细节，以便透彻理解本公开实施例。然而，本领域的技术人员应当清楚，在没有这些具体细节的其它实施例中也可以实现本公开。在其它情况中，省略对众所周知的***、装置、结构以及方法的详细说明，以免不必要的细节妨碍本公开的描述。In the following description, for the purpose of illustration rather than limitation, specific details such as specific system structures and techniques are set forth in order to provide a thorough understanding of the embodiments of the present disclosure. However, it will be apparent to those skilled in the art that the present disclosure may be practiced in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, devices, structures, and methods are omitted so as not to obscure the description of the present disclosure with unnecessary detail.

在本公开的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于医疗器械远端中心和近端中心连线的方向，径向是指垂直于轴向的方向，周向是指环绕轴向的方向。上述定义只是为了表述方便，并不能理解为对本公开的限制。In the description of the present disclosure, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther away from the operator; the axial direction refers to the end parallel to the medical device. The direction of the line connecting the center of the distal end and the center of the proximal end of the instrument, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction. The above definitions are only for the convenience of expression, and should not be construed as a limitation of the present disclosure.

实施例一Example 1

参阅图1至图4，本实施例提供了医用切线装置，其包括切线组件100、配止件200、驱动丝组300、连接套500、柔性内芯400、外支撑管组件600及手柄700。切线组件100、配止件200和驱动丝组300分别设置于外支撑管组件600内，柔性内芯400的近端从外支撑管组件600内穿出后连接手柄700上的操控件710。1 to 4 , the present embodiment provides a medical thread cutting device, which includes a thread cutting assembly 100 , a stopper 200 , a driving wire set 300 , a connecting sleeve 500 , a flexible inner core 400 , an outer support tube assembly 600 and a handle 700 . The tangent assembly 100 , the stopper 200 and the driving wire assembly 300 are respectively disposed in the outer support tube assembly 600 , and the proximal end of the flexible inner core 400 passes through the outer support tube assembly 600 and is connected to the manipulation member 710 on the handle 700 .

结合图2至图4及图7与图9，切线组件100包括固定件110及固定连接于固定件110的刀片120。配止件200包括基部220和导引部210，基部220的远端设置有切线配合面221。固定件110活动套设于导引部210上，切线配合面221位于固定件110的近侧。Referring to FIGS. 2 to 4 and FIGS. 7 and 9 , the thread cutting assembly 100 includes a fixing member 110 and a blade 120 fixedly connected to the fixing member 110 . The fitting 200 includes a base portion 220 and a guide portion 210 , and the distal end of the base portion 220 is provided with a tangential mating surface 221 . The fixing member 110 is movably sleeved on the guide portion 210 , and the tangential mating surface 221 is located at the proximal side of the fixing member 110 .

柔性内芯400的远端与连接套500的近端固定连接，连接套500的远端固定连接驱动丝组300的近端，驱动丝组300的远端固定连接固定件110。The distal end of the flexible inner core 400 is fixedly connected to the proximal end of the connecting sleeve 500 , the distal end of the connecting sleeve 500 is fixedly connected to the proximal end of the driving wire group 300 , and the distal end of the driving wire group 300 is fixedly connected to the fixing member 110 .

使用该医用切线装置时，医用线800穿出导引部210，且医用线800穿出导引部210的部分位于刀片120的刃口与切线配合面221之间，操作者通过操作操控件710控制切线组件100相对于导引部210运动，从而使刀片120的刃口抵压切线配合面221，医用线800穿出导引部210的部分抵靠切线配合面221，刀片120的刃口切断医用线800。When using the medical thread cutting device, the medical thread 800 goes out of the guide part 210 , and the part of the medical thread 800 that goes out of the guide part 210 is located between the cutting edge of the blade 120 and the thread tangent mating surface 221 , and the operator operates the manipulation member 710 Control the movement of the thread cutting assembly 100 relative to the guide part 210, so that the cutting edge of the blade 120 presses the cutting thread mating surface 221, the part of the medical wire 800 passing through the guide part 210 abuts the cutting thread matching surface 221, and the cutting edge of the blade 120 is cut off Medical Line 800.

在某些实施方案中，请参阅图4至图7，固定件110设置有轴向延伸的内腔111，内腔111轴向贯穿固定件110。固定件110轴向方向的侧面设置有安装槽113，安装槽113自固定件110的近端朝向固定件110的远端延伸。刀片120的远端与固定件110固定连接，刀片120的近端设置有尖锐的刃口，刀片120的刃口相对于固定件110朝向近端伸出。In some embodiments, please refer to FIGS. 4 to 7 , the fixing member 110 is provided with an axially extending inner cavity 111 , and the inner cavity 111 axially penetrates the fixing member 110 . An installation groove 113 is provided on the side surface of the fixing member 110 in the axial direction, and the installation groove 113 extends from the proximal end of the fixing member 110 toward the distal end of the fixing member 110 . The distal end of the blade 120 is fixedly connected with the fixing member 110 , the proximal end of the blade 120 is provided with a sharp edge, and the cutting edge of the blade 120 protrudes toward the proximal end relative to the fixing member 110 .

刀片120与固定件110的连接方式不限，可以为焊接、卡接等方式。本实施例中，为了方便刀片120的安装定位，刀片120 的远端可设置有凸起，固定件110开设与所述凸起配合的凹陷，所述凸起卡入所述凹陷中。The connection method between the blade 120 and the fixing member 110 is not limited, and may be welding, clamping or the like. In this embodiment, in order to facilitate the installation and positioning of the blade 120 , the distal end of the blade 120 may be provided with a protrusion, the fixing member 110 defines a recess matched with the protrusion, and the protrusion is snapped into the recess.

请参阅图4、图5及图8，基部220位于配止件200的近端，导引部自基部220沿轴向朝配止件200的远端延伸设置。导引部210与固定件110之间至少设置有一对相互适配的导滑面，导引部210轴向方向的相对两侧面为平面，位于两个平面之间的面为弧面，弧面与平面连接。在某些实施方案中，导引部210也可以为其它能够使得固定件110在其上沿轴向移动的结构。Referring to FIGS. 4 , 5 and 8 , the base portion 220 is located at the proximal end of the fitting member 200 , and the guide portion extends from the base portion 220 toward the distal end of the fitting member 200 in the axial direction. Between the guide portion 210 and the fixing member 110, at least a pair of guide sliding surfaces that are adapted to each other are arranged. The opposite sides of the guide portion 210 in the axial direction are flat surfaces, and the surface located between the two flat surfaces is an arc surface. Connect with the plane. In some embodiments, the guide portion 210 may also be other structures capable of allowing the fixing member 110 to move in the axial direction thereon.

基部220的远端概呈圆柱状。基部220的近端概呈圆锥状，并自远至近逐渐缩小径向尺寸。基部220的两侧分别设置有一关于基部的轴向对称的导向槽22。切线配合面221位于基部220的远端。导引部210上设置有过线孔222和侧孔223，过线孔222从导引部210远端朝向导引部210的近端延伸，在某些实施方案中，过线孔222沿轴向延伸至与切线配合面221接近齐平，侧孔223贯通过线孔222，且侧孔223的轴线与切线配合面221平行。在某些实施方案中，过线孔222与侧孔223的轴向也可以变化，只要保证两孔相贯通，侧孔223穿通导引部210上的平面即可。The distal end of the base 220 is generally cylindrical. The proximal end of the base 220 is generally conical, and the radial dimension gradually decreases from far to near. Two sides of the base portion 220 are respectively provided with a guide groove 22 which is axially symmetrical with respect to the base portion. The tangential mating surface 221 is located at the distal end of the base 220 . The guide portion 210 is provided with a wire hole 222 and a side hole 223. The wire hole 222 extends from the distal end of the guide portion 210 toward the proximal end of the guide portion 210. In some embodiments, the wire hole 222 is along the shaft. The side hole 223 passes through the line hole 222 , and the axis of the side hole 223 is parallel to the tangent line matching surface 221 . In some embodiments, the axial direction of the wire-passing hole 222 and the side hole 223 can also be changed, as long as the two holes are connected to each other and the side hole 223 passes through the plane on the guide portion 210 .

结合图3、图5与图8，本实施例中，设刀片120的刃口宽度为a，侧孔223宽度为b，待切断的医用线的股数为n，医用线直径为d。医用线被刃口与切线配合面221挤压后由圆柱状转变为扁平状，医用线的最大宽度可达w＝πd/2，即周长的一半。本实施例中，设置a≥b且b≥n×(πd/2)，一方面避免医用线脱离刀片120的刃口切割范围，另一方面防止医用线在侧孔223内过度堆叠，保证穿过侧孔223的所有医用线均能被刀片120的刃口切断，并减小切线所需的驱动力。3, 5 and 8, in this embodiment, the width of the cutting edge of the blade 120 is a, the width of the side hole 223 is b, the number of strands of the medical wire to be cut is n, and the diameter of the medical wire is d. After being squeezed by the cutting edge and the tangent mating surface 221, the medical wire changes from a cylindrical shape to a flat shape, and the maximum width of the medical wire can reach w=πd/2, that is, half of the circumference. In this embodiment, setting a≥b and b≥n×(πd/2), on the one hand, prevents the medical wire from being separated from the cutting edge cutting range of the blade 120, and on the other hand, prevents the medical wire from being excessively stacked in the side hole 223, so as to ensure the penetration of the medical wire. All medical wires passing through the side holes 223 can be cut by the cutting edge of the blade 120 and reduce the driving force required for cutting the wires.

本实施例中，如图7与图8所示，切线配合面221为围绕所述导引部210的概呈圆环形的平面。可以理解的是，本公开并不限定切线配合面221的具体形状，在某些实施方案中，切线配合面221还可以为类似于长方形、梯形、或菱形等形状。在满足切线配合面221与刀片120刃口配合的基础上，可以根据刀片120刃口的形状改变切线配合面221的形态，如：刀片120的刃口可以设置为弧形，切线配合面221设置为与刀片120的刃口相适配的弧面，能够保证刀片120的刃口能够完全抵压在切线配合面221上即可。切线配合面221可以做表面硬化处理，表面硬化处理方式可以为淬火或表面涂层，涂层可以为镍钛涂层或金刚石涂层等，从而提高切线配合面221的表面硬度及耐磨性，以为刀片120的刃口提供坚实可靠的着力点及延长切线配合面221的使用寿命。配止件200可以采用不锈钢、镍钛合金、钴铬合金或钨合金等材料制作，本实施例中配止件200的材质选择不锈钢。值得注意的是，应使得切线配合面221能够为刀片120的刃口上的各个点均提供着力点以切断全部医用线800。In this embodiment, as shown in FIGS. 7 and 8 , the tangential mating surface 221 is a substantially annular plane surrounding the guide portion 210 . It can be understood that the present disclosure does not limit the specific shape of the tangential mating surface 221 , and in some embodiments, the tangential mating surface 221 may also have a shape similar to a rectangle, a trapezoid, or a rhombus. On the basis of satisfying the matching between the tangent mating surface 221 and the cutting edge of the blade 120, the shape of the tangent mating surface 221 can be changed according to the shape of the cutting edge of the blade 120. For the arc surface to match with the cutting edge of the blade 120 , it is sufficient to ensure that the cutting edge of the blade 120 can completely press against the tangent matching surface 221 . The tangent mating surface 221 can be surface hardened, the surface hardening treatment can be quenching or surface coating, and the coating can be nickel titanium coating or diamond coating, etc., so as to improve the surface hardness and wear resistance of the tangent mating surface 221, It provides a solid and reliable force point for the cutting edge of the blade 120 and prolongs the service life of the tangent mating surface 221 . The stopper 200 can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or tungsten alloy, and the like. In this embodiment, the material of the stopper 200 is stainless steel. It is worth noting that the tangential mating surface 221 should be able to provide a force point for each point on the cutting edge of the blade 120 to cut all the medical wires 800 .

请参阅图4至图8，导引部210穿设于固定件110的内腔111内，导引部210与固定件110轴向滑动配合。导引部210上的弧 面作为导引部210与固定件110之间的导滑面，导引部210上的平面既作为导滑面，也作为止转面来限制固定件110与导引部210之间的相对转动。固定件110与导引部210配合后，刀片120位于导引部210的平面的上方，刀片120的刃口朝向切线配合面221，且刀片120可以与切线配合面221垂直或接近垂直。驱动丝组300的远端固定连接于固定件110上的安装槽113内，驱动丝组300朝向近端延伸并穿过配止件200上的导向槽224，驱动丝组300与导向槽224间隙配合，从而驱动丝组300能够沿导向槽224轴向滑动。切线时，控制驱动丝组300沿轴向向近端移动，驱动丝组300便拉动固定件110朝向导引部210做轴向移动。为了保证固定件110轴向移动的稳定性，驱动丝组300可设置有两个，该两个驱动丝组300关于固定件110及配止件200的轴向对称设置，相应的，安装槽113和导向槽224分别设置有两个，两个安装槽113对称设置于固定件110轴向方向的两侧，两个导向槽224对称设置于基部220轴向方向的两侧。两个驱动丝组300的近端均与连接套500固定连接。Please refer to FIGS. 4 to 8 , the guide portion 210 is inserted through the inner cavity 111 of the fixing member 110 , and the guide portion 210 is axially slidably engaged with the fixing member 110 . The arc surface on the guide portion 210 serves as a sliding surface between the guide portion 210 and the fixing member 110 , and the flat surface on the guiding portion 210 serves as both a sliding surface and a rotation stop surface to limit the fixing member 110 and the guide member 110 . relative rotation between parts 210 . After the fixing member 110 is matched with the guide portion 210 , the blade 120 is located above the plane of the guide portion 210 , the cutting edge of the blade 120 faces the tangent mating surface 221 , and the blade 120 can be perpendicular or nearly perpendicular to the tangent mating surface 221 . The distal end of the driving wire group 300 is fixedly connected to the installation groove 113 on the fixing member 110 , the driving wire group 300 extends toward the proximal end and passes through the guide groove 224 on the fitting member 200 , and the driving wire group 300 has a gap between the guide groove 224 Matching, so that the driving wire group 300 can slide axially along the guide groove 224 . When the thread is cut, the driving wire group 300 is controlled to move toward the proximal end in the axial direction, and the driving wire group 300 pulls the fixing member 110 to move axially toward the guide portion 210 . In order to ensure the stability of the axial movement of the fixing member 110 , two driving wire groups 300 may be provided, and the two driving wire groups 300 are arranged symmetrically with respect to the axial direction of the fixing member 110 and the fitting member 200 . Correspondingly, the installation grooves 113 There are two guide grooves 224 respectively, the two installation grooves 113 are symmetrically arranged on both sides of the fixing member 110 in the axial direction, and the two guide grooves 224 are symmetrically arranged on both sides of the base 220 in the axial direction. The proximal ends of the two driving wire groups 300 are fixedly connected with the connecting sleeve 500 .

请参阅图1、图9、图10和图11，手柄700还包括上壳720、下壳730、外管固定件740、内管固定件750、内芯连接件760及弹性件770；控件710包括按钮连接件712和控制按钮711；外支撑管组件600包括套筒610、柔性外管620及限位销630。1 , 9 , 10 and 11 , the handle 700 further includes an upper shell 720 , a lower shell 730 , an outer tube fixing member 740 , an inner tube fixing member 750 , an inner core connecting member 760 and an elastic member 770 ; a control 710 It includes a button connector 712 and a control button 711 ; the outer support tube assembly 600 includes a sleeve 610 , a flexible outer tube 620 and a limit pin 630 .

在某些实施方案中，上壳720与下壳730扣合连接形成手柄700的壳体；外管固定件740、内管固定件750、内芯连接件760及弹性件770均安装于壳体内部；柔性外管620的近端连接外管固定件740，连接方式可以但不限于为粘接；柔性内芯400从柔性外管620穿出后伸入壳体内，柔性内芯400的近端固定连接内芯连接件760；按钮连接件712套设于内芯连接件760的近端，且按钮连接件712与内芯连接件760固定连接；控制按钮711固定连接按钮连接件712，控制按钮711伸出于上壳720；弹性件770被压缩于按钮连接件712与下壳730的内壁之间，弹性件770提供控制按钮711的复位力，使得控制按钮711总是趋向于恢复其初始位置。弹性件770可设置于控制按钮711的近端侧，也可设置于控制按钮711的远端侧，本实施例中，弹性件770可以采用弹簧，弹簧的一端连接按钮连接件712，弹簧的另一端抵接下壳730的内壁。In some embodiments, the upper shell 720 and the lower shell 730 are snap-connected to form a shell of the handle 700; the outer tube fixing member 740, the inner tube fixing member 750, the inner core connecting member 760 and the elastic member 770 are all mounted on the casing Inside; the proximal end of the flexible outer tube 620 is connected to the outer tube fixing member 740, and the connection method can be but not limited to bonding; the flexible inner core 400 protrudes into the casing after passing through the flexible outer tube 620, and the proximal end of the flexible inner core 400 The inner core connector 760 is fixedly connected; the button connector 712 is sleeved on the proximal end of the inner core connector 760, and the button connector 712 is fixedly connected with the inner core connector 760; the control button 711 is fixedly connected to the button connector 712, the control button 711 protrudes from the upper shell 720; the elastic member 770 is compressed between the button connecting member 712 and the inner wall of the lower shell 730, the elastic member 770 provides the restoring force of the control button 711, so that the control button 711 always tends to restore its original position . The elastic member 770 can be arranged on the proximal side of the control button 711 or on the distal side of the control button 711. In this embodiment, the elastic member 770 can be a spring, one end of the spring is connected to the button connecting member 712, and the other One end abuts against the inner wall of the lower case 730 .

本实施例中，柔性内芯400为具有抗扭支撑力的柔性体，可以为激光切割管、弹簧及多层实心芯轴等柔性体，本案例中，柔性内芯400选用由多层柔性丝缠绕而成的实心芯轴。In this embodiment, the flexible inner core 400 is a flexible body with torsional supporting force, which can be a flexible body such as a laser-cut tube, a spring, and a multi-layer solid mandrel. In this case, the flexible inner core 400 is made of multi-layer flexible wire Winding solid mandrel.

结合图2、图3、图4与图10，切线组件100和配止件200收容于套筒610内，配止件200的基部220朝向近端方向部分伸出套筒610；套筒610设置有进线孔611和出线孔612，进线孔611与所述过线孔222连通，出线孔612对应与侧孔223连通；柔性外管620的远端固定连接套筒610的近端；所述基部220上设置有销孔(未标示)，限位销630穿过销孔，套筒610对应限位销630 的位置开设有固定孔，限位销630的两端***套筒610的固定孔并与套筒610通过焊接等方式固定，从而实现套筒610与配止件200之间的固定连接。2, 3, 4 and 10, the thread cutting assembly 100 and the fitting 200 are accommodated in the sleeve 610, and the base 220 of the fitting 200 partially protrudes from the sleeve 610 toward the proximal direction; the sleeve 610 is provided There are wire inlet holes 611 and wire outlet holes 612, the wire inlet holes 611 are communicated with the wire passage holes 222, and the wire outlet holes 612 are communicated with the side holes 223 correspondingly; the distal end of the flexible outer tube 620 is fixedly connected to the proximal end of the sleeve 610; The base 220 is provided with a pin hole (not shown), the limit pin 630 passes through the pin hole, the sleeve 610 has a fixing hole corresponding to the position of the limit pin 630 , and the two ends of the limit pin 630 are inserted into the sleeve 610 for fixing The hole is fixed to the sleeve 610 by welding or the like, so as to realize the fixed connection between the sleeve 610 and the fitting 200 .

柔性外管620可采用弹簧管，柔性外管620的材料可选不锈钢、镍钛合金、钴铬合金或钨合金，本实施例中柔性外管620的材质选择不锈钢。为了减少驱动切线组件100时柔性内芯400与柔性外管620之间的摩擦，柔性内芯400外还可以套设光滑的柔性内管410，柔性内管410的远端延伸至靠近连接套500的近端，柔性内管410的近端从柔性外管620伸出并伸入壳体，柔性内管410的近端与内管固定件750固定连接。柔性内管410可选用摩擦系数交小的高分子材料，如PEEK管、Pebax管及PTFE管等柔性管体，本实施例选用PTFE管，其中，PEEK指聚醚醚酮，Pebax指聚醚嵌段聚酰胺，PTFE指聚四氟乙烯。The flexible outer tube 620 can be a spring tube, and the material of the flexible outer tube 620 can be selected from stainless steel, nickel-titanium alloy, cobalt-chromium alloy or tungsten alloy. In this embodiment, the material of the flexible outer tube 620 can be selected from stainless steel. In order to reduce the friction between the flexible inner core 400 and the flexible outer tube 620 when driving the wire cutting assembly 100 , a smooth flexible inner tube 410 can be sheathed outside the flexible inner core 400 , and the distal end of the flexible inner tube 410 extends to be close to the connecting sleeve 500 The proximal end of the flexible inner tube 410 protrudes from the flexible outer tube 620 and extends into the housing, and the proximal end of the flexible inner tube 410 is fixedly connected with the inner tube fixing member 750 . The flexible inner tube 410 can be made of a polymer material with a small friction coefficient, such as PEEK tube, Pebax tube and PTFE tube. segment polyamide, PTFE refers to polytetrafluoroethylene.

请参阅图1、图2、图3、图9、图10和图11，医用线800可自所述进线孔611与过线孔222穿入，自所述侧孔223与出线孔612穿出，医用线800自侧孔223穿出的部分位于刀片120的刃口与切线配合面221之间；切线时，操作者向近端拉动控制按钮711，控制按钮711将拉力传递至柔性内芯400，柔性内芯400再通过连接套500和驱动丝组300拉动固定件110朝向近端移动，刀片120把医用线800抵压在切线配合面221上，然后再进一步向近端拉动控制按钮711，使刀片120的刃口将医用线800在切线配合面221上切断；停止对控制按钮711施加拉力后，控制按钮711在弹性件770提供的弹性力作用下复位，带动着柔性内芯400、连接套500、驱动丝组300及固定件110向远端移动，使得刀片120的刃口与切线配合面221分离，完成切线动作。Please refer to FIG. 1 , FIG. 2 , FIG. 3 , FIG. 9 , FIG. 10 and FIG. 11 , the medical wire 800 can be passed through the wire inlet hole 611 and the wire passing hole 222 , and the medical wire 800 can be passed through the side hole 223 and the wire outlet hole 612 Out, the part of the medical wire 800 passing through the side hole 223 is located between the cutting edge of the blade 120 and the tangent mating surface 221; when tangent, the operator pulls the control button 711 to the proximal end, and the control button 711 transmits the pulling force to the flexible inner core 400, the flexible inner core 400 pulls the fixing member 110 toward the proximal end through the connecting sleeve 500 and the driving wire set 300, and the blade 120 presses the medical wire 800 against the tangent mating surface 221, and then further pulls the control button 711 towards the proximal end , so that the cutting edge of the blade 120 cuts the medical wire 800 on the tangent mating surface 221; after the pulling force is stopped on the control button 711, the control button 711 is reset under the action of the elastic force provided by the elastic member 770, which drives the flexible inner core 400, The connecting sleeve 500 , the driving wire group 300 and the fixing member 110 move to the distal end, so that the cutting edge of the blade 120 is separated from the tangent mating surface 221 to complete the tangent action.

本实施例中，通过驱动丝组300拉动固定件110沿导引部210向近端做轴向移动，刀片120的刃口把医用线800抵压在切线配合面221上切断，切线配合面221一方面为医用线800提供抵靠，另一方面为刀片120的刃口提供着力点，从而使得医用线800易于被切断；同时，由于刀片120的刃口与切线配合面221之间是相互抵压的关系，不会产生类似于剪刀那样的相互交错关系，从而刀片120与切线配合面221之间也不存在挤线的异常情况，保证医用切线装置可以顺利撤回，避免了因挤线拉扯器官组织的风险。此外，由于需介入体内，柔性内芯400会顺应人体管腔的弯曲而弯曲，本实施例中，将刀片120的驱动方式设置为朝向近端的后拉式，拉力在柔性内芯400上更易于传递且损耗较小，刀片120切线时需的驱动力便更小，更省力。In this embodiment, by driving the wire group 300 to pull the fixing member 110 to move axially toward the proximal end along the guide portion 210 , the cutting edge of the blade 120 presses the medical wire 800 against the tangent mating surface 221 to cut off the tangent mating surface 221 On the one hand, it provides abutment for the medical wire 800, and on the other hand, it provides a force point for the cutting edge of the blade 120, so that the medical wire 800 is easy to be cut; There is no staggered relationship similar to scissors, so there is no abnormal situation of thread extrusion between the blade 120 and the tangent mating surface 221, which ensures that the medical thread tangent device can be withdrawn smoothly and avoids pulling the organ due to the extrusion thread. organizational risk. In addition, the flexible inner core 400 will bend in accordance with the bending of the human body lumen due to the need to be inserted into the body. In this embodiment, the driving mode of the blade 120 is set as a back-pulling type toward the proximal end, and the pulling force on the flexible inner core 400 is stronger. Easy to transmit and less loss, the driving force required by the blade 120 to cut the thread is smaller and labor-saving.

以三尖瓣瓣膜缘对缘修复为例，本实施例中的医用切线装置使用过程如下：Taking the edge-to-edge repair of the tricuspid valve as an example, the use process of the medical tangent device in this embodiment is as follows:

第一步：在患者体外把已经植入在三尖瓣三个瓣叶上且经一锁钉固定的多根医用线自医用切线装置的套筒610的进线孔611及导引部210的过线孔222穿入，自导引部210的侧孔223及套筒600的出线孔612穿出；Step 1: Take a plurality of medical wires that have been implanted on the three leaflets of the tricuspid valve and fixed by a locking nail from the wire inlet hole 611 of the sleeve 610 of the medical tangent device and the guide part 210 outside the patient's body. The wire-passing hole 222 passes through, and passes through the side hole 223 of the guide portion 210 and the wire outlet hole 612 of the sleeve 600;

第二步：顺着医用线的引导，将医用切线装置的远端经股静脉、上腔静脉输送至心脏右心房，向三尖瓣的瓣叶及锁钉移动靠近，直至该医用切线装置的远端到达预定位置；Step 2: Following the guidance of the medical thread, the distal end of the medical thread tangent device is delivered to the right atrium of the heart through the femoral vein and superior vena cava, and moves closer to the leaflet and locking pin of the tricuspid valve until the The far end reaches the predetermined position;

第三步：后拉手柄700上的控制按钮711，固定件110带动刀片120沿轴向向近端移动，把全部医用线压在切线配合面221上，然后切断医用线，之后松开控制按钮711，在弹性件770的弹力作用下，控制按钮711自动复位，固定件110及刀片120自动沿着轴向向远端移动；以及Step 3: Pull back the control button 711 on the handle 700, the fixing member 110 drives the blade 120 to move proximally in the axial direction, presses all the medical wires on the tangent mating surface 221, then cuts the medical wires, and then releases the control button 711, under the elastic force of the elastic member 770, the control button 711 is automatically reset, and the fixing member 110 and the blade 120 are automatically moved to the distal end along the axial direction; and

第四步：将医用切线装置与多余的医用线撤出患者体外，此时右心房内留置的锁钉使得分别穿过前叶、后叶和隔叶的三组缝线固定在一起，三尖瓣的前叶、后叶和隔叶的部分边缘相互对合，完成缘对缘修复。The fourth step: withdraw the medical tangent device and the redundant medical thread out of the patient's body. At this time, the locking nails indwelling in the right atrium make the three sets of sutures passing through the anterior lobe, posterior lobe and septal lobe to be fixed together. Part of the edges of the anterior leaflet, posterior leaflet and septal leaflet of the valve are joined to each other to complete edge-to-edge repair.

当然，本实施例的医用切线装置也可以应用于二尖瓣缘对缘修复手术中的医用线切断。还可以应用于瓣膜腱索修复术中的医用线切断，瓣膜不限于二尖瓣和三尖瓣，在作为人工腱索的医用线部分被缝合在瓣膜上，部分被锚入心室壁或***肌上的锚钉固定好之后，参照上述步骤，使用该医用切线装置介入心脏内将医用线切断。Of course, the medical thread cutting device of this embodiment can also be applied to cutting the medical thread in the edge-to-edge repair operation of the mitral valve. It can also be applied to the cutting of medical thread in valve chordae tendineae repair. The valve is not limited to mitral valve and tricuspid valve. The medical thread as artificial chordae tendineae is partially sutured on the valve and partially anchored into the ventricular wall or papillary muscle. After the upper anchor is fixed, referring to the above steps, use the medical thread cutting device to intervene in the heart to cut the medical thread.

在某些实施方案中，医用线还可以是单纯用于缝合切口或破口的缝线，用于植入在瓣环等人体内部组织上的缝线等，医用线的材料包括但不限于PTFE、e-PTFE、PET、UHMWPE等。本实施例的医用切线装置适于对前述的各种用途的缝线进行切断。In some embodiments, the medical thread can also be a suture that is simply used to suture an incision or a breach, a suture that is implanted on human internal tissues such as the valve annulus, etc. The material of the medical thread includes but is not limited to PTFE , e-PTFE, PET, UHMWPE, etc. The medical thread cutting device of this embodiment is suitable for cutting sutures for various purposes as described above.

实施例二Embodiment 2

请参阅图12至图16，本公开实施例二的医用切线装置与实施例一的医用切线装置相比，切线组件与配止件的结构做了改变。Referring to FIGS. 12 to 16 , the medical thread cutting device of the second embodiment of the present disclosure is compared with the medical thread cutting device of the first embodiment in that the structures of the thread cutting assembly and the fitting are changed.

本实施例二中，切线组件包括固定件110和刀片120。固定件110开设有内腔111，内腔111不再封闭，而是具有下方缺口112，下方缺口112轴向贯穿固定件110。配止件包括基部220和导引部210，导引部210自基部220沿轴向朝远端延伸设置。固定件110与导引部210轴向滑动配合。导引部210设置有穿通导引部210远端面的过线孔222及与过线孔222贯通的侧孔223。In the second embodiment, the thread cutting assembly includes a fixing member 110 and a blade 120 . The fixing member 110 is provided with an inner cavity 111 , and the inner cavity 111 is no longer closed, but has a lower gap 112 , and the lower gap 112 axially penetrates the fixing member 110 . The fitting includes a base portion 220 and a guide portion 210 , and the guide portion 210 extends from the base portion 220 toward the distal end in the axial direction. The fixing member 110 is axially slidably fitted with the guide portion 210 . The guide portion 210 is provided with a wire hole 222 penetrating the distal end surface of the guide portion 210 and a side hole 223 passing through the wire hole 222 .

基部220的远端还连接有轴向延伸段225，轴向延伸段225在上方遮盖导引部210。基部220的远端设置平面形态的切线配合面221，切线配合面221位于轴向延伸段225与导引部210之间，切线配合面221的底端与基部220的中轴线靠近或平齐，切线配合面221与基部220的外周面相交。刀片120位于轴向延伸段225与导引部210之间，在基部220远端外径相同的条件下，切线配合面221的宽度增大，刀片120刃口的宽度可相应增大，更能提高切线的可靠性；在待切断医用线800数量相同的条件下，能够减小基部220远端的外径尺寸，更有利于在人体管腔内输送。The distal end of the base portion 220 is also connected with an axially extending portion 225 , which covers the guide portion 210 above. The distal end of the base portion 220 is provided with a tangential mating surface 221 in a planar shape, the tangential mating surface 221 is located between the axially extending section 225 and the guide portion 210, and the bottom end of the tangential mating surface 221 is close to or flush with the central axis of the base portion 220, The tangential mating surface 221 intersects the outer peripheral surface of the base 220 . The blade 120 is located between the axially extending section 225 and the guide portion 210. Under the condition that the outer diameter of the distal end of the base portion 220 is the same, the width of the tangent mating surface 221 is increased, and the width of the cutting edge of the blade 120 can be correspondingly increased. The reliability of the tangent is improved; under the condition that the number of the medical wires 800 to be cut is the same, the outer diameter of the distal end of the base 220 can be reduced, which is more conducive to the delivery in the human body lumen.

在某些实施方案中，在满足切线配合面221与刀片120刃口配合的基础上，可以根据刀片120刃口的形状改变切线配合面221 的形态，如：刀片120的刃口可以设置为弧形，切线配合面221设置为与刀片120的刃口相适配的弧面，保证刀片120的刃口能够完全抵压在切线配合面221上即可。In some embodiments, the shape of the tangent mating surface 221 can be changed according to the shape of the cutting edge of the blade 120 on the basis of satisfying the matching between the tangent mating surface 221 and the cutting edge of the blade 120, for example, the cutting edge of the blade 120 can be set as an arc The tangent mating surface 221 is set as an arc surface that matches the cutting edge of the blade 120 to ensure that the cutting edge of the blade 120 can completely press against the tangent mating surface 221 .

本实施例二中的固定件110的结构相对于实施例一中的固定件110更加扁平，固定件110的上端与轴向延伸段225的下端平面贴合，固定件110的下端开放并活动套设在导引部210上，导引部210与轴向延伸段225分别限制固定件110向下移动、向上移动的自由度。The structure of the fixing member 110 in the second embodiment is flatter than that of the fixing member 110 in the first embodiment. The upper end of the fixing member 110 is in plane fit with the lower end of the axially extending section 225 , and the lower end of the fixing member 110 is open and movable. The guide portion 210 is provided on the guide portion 210 , and the guide portion 210 and the axially extending section 225 respectively restrict the degrees of freedom of the downward movement and the upward movement of the fixing member 110 .

本实施例二中医用切线装置的其它结构均与实施例一相同，此处不再赘述。本实施例二中医用切线装置的使用方式与实施例一相同，此处不再赘述。The other structures of the TCM thread cutting device in the second embodiment are the same as those in the first embodiment, and will not be repeated here. The use of the TCM thread cutting device in the second embodiment is the same as that in the first embodiment, and will not be repeated here.

请参阅图17、图18和图19，实施例一与实施例二中的刀片120的刃口形状可以为对称型、偏心型或单边型，其中，对称型刃口的角度为θ ₁，偏心型的刃口的角度为θ ₂，单边型的刃口角度为θ ₃，θ ₁、θ ₂及θ ₃的角度范围均可在10°至150°之间，刃口的角度越小，刀片120的刃口就越锋利。在某些实施方案中，刀片120具有对称型的刃口，刃口的角度可以为30°。 Please refer to FIG. 17 , FIG. 18 and FIG. 19 , the shape of the cutting edge of the blade 120 in the first and second embodiments can be symmetrical, eccentric or unilateral, wherein the angle of the symmetrical cutting edge is θ ₁ , The angle of the edge of the eccentric type is θ ₂ , the angle of the edge of the unilateral type is θ ₃ , the angle range of θ ₁ , θ ₂ and θ ₃ can be between 10° and 150°, the smaller the angle of the edge is. , the sharper the cutting edge of the blade 120 is. In certain embodiments, the blade 120 has a symmetrical cutting edge, which may be angled at 30°.

实施例三Embodiment 3

请参阅图20至图22，本公开实施例三的医用切线装置与实施例的医用切线装置相比，切线组件100与配止件200的结构做了改变。Referring to FIGS. 20 to 22 , compared with the medical thread cutting device of the third embodiment of the present disclosure, the structures of the thread cutting assembly 100 and the fitting 200 are changed.

本实施例三中，配止件200包括导引部210和基部220，导引部210概呈圆柱状结构，基部220绕导引部210的轴向延伸设置而覆盖导引部210的部分外周面，切线配合面221凸出于导引部210的外周面并沿导引部210的轴向延伸。切线组件100包括固定件110及与固定件110固定连接的刀片120，固定件110和刀片120均绕导引部210的轴向延伸设置，导引部210与固定件110之间设置有相互适配的弧面，固定件110活动套设于所述导引部210上，固定件110与导引部210之间转动配合。In the third embodiment, the stopper 200 includes a guide portion 210 and a base portion 220 , the guide portion 210 is substantially cylindrical, and the base portion 220 extends around the axial direction of the guide portion 210 to cover part of the outer circumference of the guide portion 210 The tangential mating surface 221 protrudes from the outer peripheral surface of the guide portion 210 and extends along the axial direction of the guide portion 210 . The thread cutting assembly 100 includes a fixing member 110 and a blade 120 fixedly connected with the fixing member 110. Both the fixing member 110 and the blade 120 are arranged around the axial extension of the guide portion 210. The fixed part 110 is movably sleeved on the guide part 210 , and the fixed part 110 and the guide part 210 are rotatably matched.

固定件110设置有绕导引部210轴线延伸的弧形缺口114，限位销630部分穿插于导引部210内，另一部分从弧形缺口114处沿径向伸出并与套筒610固定连接，从而将导引部210与套筒610固定。导引部210开设有穿通导引部210远端面的过线孔222及与过线孔222贯通的侧孔223，侧孔223穿通导引部210的外周面，医用线800自所述过线孔222穿入，自所述侧孔223穿出，且医用线800自所述侧孔223穿出的部分位于刀片120的刃口与切线配合面221之间。The fixing member 110 is provided with an arc-shaped notch 114 extending around the axis of the guide portion 210 , a portion of the limiting pin 630 is inserted into the guide portion 210 , and the other portion extends radially from the arc-shaped notch 114 and is fixed to the sleeve 610 connected to fix the guide portion 210 and the sleeve 610 . The guide portion 210 is provided with a wire hole 222 penetrating the distal surface of the guide portion 210 and a side hole 223 passing through the wire hole 222. The wire hole 222 passes through the side hole 223 , and the portion of the medical wire 800 that passes through the side hole 223 is located between the cutting edge of the blade 120 and the tangent mating surface 221 .

参照实施例一，可以理解的是，本实施例三中，可通过驱动丝组、柔性内芯及手柄上的操控件控制固定件100相对导引部210转动。进一步地，驱动丝组可设置一个，驱动丝组的远端连接固定件110，驱动丝组的近端连接柔性内芯，柔性内芯连接手柄上的操控件，通过旋转操控件带动柔性内芯绕及驱动丝组转动，从而 驱动固定件100及刀片120绕导引部210的轴向并朝向切线配合面221转动，刀片120将医用线800抵压在切线配合面221上，切断医用线800。可以理解的是，本实施例三中，手柄内还可设置弹性件，所述弹性件被压缩于所述操控件与所述手柄的内壁之间，以使所述操控件复位，从而使得切线完成后，刀片120自动离开切线配合面221。Referring to the first embodiment, it can be understood that, in the third embodiment, the rotation of the fixing member 100 relative to the guide portion 210 can be controlled by the driving wire group, the flexible inner core and the manipulation member on the handle. Further, one driving wire group may be provided, the distal end of the driving wire group is connected to the fixing member 110, the proximal end of the driving wire group is connected to the flexible inner core, and the flexible inner core is connected to the manipulation member on the handle, and the flexible inner core is driven by the rotating manipulation member. Winding and driving the wire group to rotate, thereby driving the fixing member 100 and the blade 120 to rotate around the axial direction of the guide portion 210 and toward the tangent mating surface 221, the blade 120 presses the medical wire 800 on the tangent mating surface 221, and cuts the medical wire 800 . It can be understood that, in the third embodiment, an elastic member can also be arranged in the handle, and the elastic member is compressed between the control member and the inner wall of the handle, so as to reset the control member, so as to make the tangent line After completion, the blade 120 automatically leaves the tangent mating surface 221 .

在套筒610相同外径的条件下，本实施例三中切线组件100与配止件200的转动配合结构更有利于增大切线配合面221的宽度及刀片120刃口的宽度，更有效提高切线的可靠性。此外，将刀片120的驱动方式设置为旋转式，扭转力在弯曲的柔性内芯上也更易于传递、力的损耗较小，切线所需的驱动力更小，更省力。Under the condition that the outer diameter of the sleeve 610 is the same, the rotation matching structure of the tangent assembly 100 and the stopper 200 in the third embodiment is more conducive to increasing the width of the tangent matching surface 221 and the width of the cutting edge of the blade 120, which is more effective in increasing the Tangent reliability. In addition, if the driving mode of the blade 120 is set as a rotary type, the torsional force is also easier to transmit on the curved flexible inner core, the force loss is smaller, and the driving force required for tangent is smaller and less labor-saving.

该实施例三中，切线配合面221仍可以为平面，但在某些实施方案中，在满足切线配合面221与刀片120刃口配合的基础上，可以根据刀片120刃口的形状改变切线配合面221的形态，如：刀片120的刃口可以设置为弧形，切线配合面221设置为与刀片120的刃口相适配的弧面，保证刀片120的刃口能够完全抵压在切线配合面221上即可。In the third embodiment, the tangent mating surface 221 can still be a plane, but in some embodiments, on the basis of satisfying the mating between the tangent mating surface 221 and the cutting edge of the blade 120 , the tangent mating can be changed according to the shape of the cutting edge of the blade 120 The shape of the surface 221, such as: the cutting edge of the blade 120 can be set as an arc, and the tangential mating surface 221 is set as an arc surface that matches the cutting edge of the blade 120 to ensure that the cutting edge of the blade 120 can be completely pressed against the tangential matching surface. on the surface 221.

可以理解的，以上实施例仅表达了本公开的某些实施方式，其描述较为具体和详细，但并不能因此而理解为对本公开专利范围的限制；应当指出的是，对于本领域的普通技术人员来说，在不脱离本公开构思的前提下，可以对上述技术特点进行自由组合，还可以做出若干变形和改进，这些都属于本公开的保护范围；因此，凡跟本公开权利要求范围所做的等同变换与修饰，均应属于本公开权利要求的涵盖范围。It can be understood that the above embodiments only represent some embodiments of the present disclosure, and the descriptions thereof are relatively specific and detailed, but should not be construed as a limitation on the scope of the present disclosure; For personnel, on the premise of not departing from the concept of the present disclosure, the above-mentioned technical features can be freely combined, and some deformations and improvements can also be made, which all belong to the protection scope of the present disclosure; All equivalent transformations and modifications made shall fall within the scope of the claims of the present disclosure.

Claims (20)

1. 医用切线装置，其包括：A medical thread cutting device, comprising:

   切线组件，所述切线组件包括固定件及连接于所述固定件的刀片；以及a thread cutting assembly, the thread cutting assembly including a fixing member and a blade connected to the fixing member; and

   配止件，所述配止件包括基部及导引部；a fitting, the fitting includes a base and a guide;

   其中，所述基部设置有切线配合面，所述固定件活动套设于所述导引部上，所述刀片具有刃口，医用线至少部分位于所述刃口与所述切线配合面之间；所述固定件相对于所述导引部运动以带动所述刀片的刃口抵压所述切线配合面时，所述医用线至少部分抵靠所述切线配合面并被所述刃口切断。Wherein, the base is provided with a tangent mating surface, the fixing member is movably sleeved on the guide portion, the blade has a cutting edge, and the medical wire is at least partially located between the cutting edge and the tangent mating surface ; When the fixing member moves relative to the guide portion to drive the cutting edge of the blade to press against the tangent matching surface, the medical wire at least partially abuts the tangential matching surface and is cut by the cutting edge .
2. 如权利要求1所述的医用切线装置，其中，所述导引部开设有穿通所述导引部远端面的过线孔及与所述过线孔贯通的侧孔，所述医用线自所述过线孔穿入，自所述侧孔穿出，且所述医用线自所述侧孔穿出的部分位于所述刃口与所述切线配合面之间。The medical thread cutting device according to claim 1, wherein the guide portion is provided with a wire passage hole passing through the distal end surface of the guide portion and a side hole passing through the wire passage hole, and the medical wire is opened from The wire-passing hole is inserted into and out from the side hole, and the part of the medical wire that is passed out from the side hole is located between the cutting edge and the tangent matching surface.
3. 如权利要求2所述的医用切线装置，其中，所述刀片的刃口宽度为a，所述侧孔的宽度为b，所述医用线的股数为n，所述医用线的直径为d；The medical thread cutting device according to claim 2, wherein the width of the cutting edge of the blade is a, the width of the side hole is b, the number of strands of the medical wire is n, and the diameter of the medical wire is d ;

   其中，a≥b且b≥n×(πd/2)。where a≥b and b≥n×(πd/2).
4. 如权利要求1至3中任一权利要求所述的医用切线装置，其中，所述固定件设置有沿轴向延伸的内腔，所述导引部活动穿设于所述固定件的内腔内。The medical thread cutting device according to any one of claims 1 to 3, wherein the fixing member is provided with an inner cavity extending in the axial direction, and the guide portion is movably penetrated through the inner cavity of the fixing member Inside.
5. 如权利要求1至4中任一权利要求所述的医用切线装置，其中，所述切线组件还包括至少一个驱动丝组，所述驱动丝组的远端固定连接所述固定件，所述驱动丝组运动带动所述固定件相对于所述导引部运动。The medical thread cutting device according to any one of claims 1 to 4, wherein the thread cutting assembly further comprises at least one driving wire group, the distal end of the driving wire group is fixedly connected to the fixing member, and the driving wire group is The movement of the wire group drives the fixing member to move relative to the guide portion.
6. 如权利要求5所述的医用切线装置，其中，所述切线配合面位于所述固定件的近侧，所述驱动丝组沿轴向向近端运动以拉动所述固定件相对于所述导引部运动。The medical wire cutting device according to claim 5, wherein the cutting wire mating surface is located at the proximal side of the fixing member, and the driving wire group moves proximally in the axial direction to pull the fixing member relative to the guide member. Lead movement.
7. 如权利要求6所述的医用切线装置，其中，所述基部沿轴向方向开设有导向槽，所述驱动丝组与所述导向槽间隙配合，以使所述驱动丝组沿所述导向槽轴向滑动。The medical thread cutting device according to claim 6, wherein the base is provided with a guide groove along the axial direction, and the driving wire group is clearance-fitted with the guide groove, so that the driving wire group can follow the guide groove. Axial sliding.
8. 如权利要求6或7所述的医用切线装置，其中，所述驱动丝组设置有两个，两个所述驱动丝组关于所述固定件的轴向对称。The medical thread cutting device according to claim 6 or 7, wherein there are two driving wire groups, and the two driving wire groups are symmetrical with respect to the axial direction of the fixing member.
9. 如权利要求1至8中任一权利要求所述的医用切线装置，其中，所述固定件与所述导引部轴向滑动配合，所述导引部与所 述固定件之间设有至少一对相互适配的导滑面。The medical thread cutting device according to any one of claims 1 to 8, wherein the fixing member is axially slidably fitted with the guide portion, and at least a A pair of mutually matched guide surfaces.
10. 如权利要求9所述的医用切线装置，其中，所述导引部自所述基部的远端沿轴向延伸，所述切线配合面设置于所述基部的远端，所述切线配合面为围绕所述导引部设置的概呈圆环形的面。The medical thread cutting device according to claim 9, wherein the guide portion extends axially from the distal end of the base portion, and the tangential mating surface is provided at the distal end of the base portion, and the tangential mating surface is A generally annular surface provided around the guide portion.
11. 如权利要求9所述的医用切线装置，其中，所述导引部自所述基部的远端沿轴向延伸，所述切线配合面设置于所述基部的远端，所述切线配合面的底端与所述基部的中轴线平齐或靠近，所述切线配合面与所述基部的外周面相交。The medical thread cutting device according to claim 9, wherein the guide portion extends axially from the distal end of the base portion, the tangential mating surface is provided at the distal end of the base portion, and the tangential mating surface is The bottom end is flush with or close to the central axis of the base, and the tangential mating surface intersects with the outer peripheral surface of the base.
12. 如权利要求11所述的医用切线装置，其中，所述基部的远端还连接有轴向延伸段，所述轴向延伸段遮盖所述导引部，所述切线组件位于所述轴向延伸段与所述导引部之间。The medical thread cutting device according to claim 11, wherein the distal end of the base is further connected with an axially extending section, the axially extending section covers the guiding section, and the cutting assembly is located in the axially extending section. between the segment and the guide.
13. 如权利要求1至5中任一权利要求所述的医用切线装置，其中，所述固定件与所述导引部绕所述导引部的轴向转动配合，所述基部绕所述导引部的轴向延伸设置，所述切线配合面凸出于所述导引部的外周面并沿所述导引部的轴向延伸。The medical thread cutting device according to any one of claims 1 to 5, wherein the fixing member is engaged with the axial rotation of the guide portion around the guide portion, and the base portion rotates around the guide portion. The tangential mating surface protrudes from the outer peripheral surface of the guide part and extends along the axial direction of the guide part.
14. 如权利要求1至13中任一权利要求所述的医用切线装置，其还包括柔性内芯及外支撑管组件；The medical thread cutting device according to any one of claims 1 to 13, further comprising a flexible inner core and an outer support tube assembly;

    其中，所述柔性内芯的远端连接所述固定件，所述柔性内芯、所述切线组件及所述配止件容置于所述外支撑管组件内。Wherein, the distal end of the flexible inner core is connected to the fixing piece, and the flexible inner core, the tangent component and the matching piece are accommodated in the outer support tube component.
15. 如权利要求14所述的医用切线装置，其中，所述外支撑管组件包括：The medical thread cutting device of claim 14, wherein the outer support tube assembly comprises:

    套筒，所述套筒上开设有进线孔及出线孔，所述切线组件与所述配止件容置于所述套筒内，所述配止件与所述套筒固定连接；以及a sleeve, the sleeve is provided with a wire inlet hole and a wire outlet hole, the wire tangent component and the matching piece are accommodated in the sleeve, and the matching piece is fixedly connected to the sleeve; and

    柔性外管，所述柔性外管的远端固定连接所述套筒的近端，所述柔性内芯活动穿设于所述柔性外管内。A flexible outer tube, the distal end of the flexible outer tube is fixedly connected to the proximal end of the sleeve, and the flexible inner core is movably penetrated in the flexible outer tube.
16. 如权利要求15所述的医用切线装置，其还包括手柄；The medical thread cutting device of claim 15, further comprising a handle;

    其中，所述柔性外管的近端固定连接至所述手柄的远端，所述手柄上设有操控件，所述操控件连接所述柔性内芯的近端，以控制所述柔性内芯沿轴向移动或绕轴向转动。Wherein, the proximal end of the flexible outer tube is fixedly connected to the distal end of the handle, the handle is provided with a manipulation member, and the manipulation member is connected to the proximal end of the flexible inner core to control the flexible inner core Move or rotate in the axial direction.
17. 如权利要求16所述的医用切线装置，其中，所述手柄内还设有弹性件，所述弹性件被压缩于所述操控件与所述手柄的内壁之间，以使所述操控件复位。The medical thread cutting device according to claim 16, wherein an elastic member is further provided in the handle, and the elastic member is compressed between the manipulation member and the inner wall of the handle to reset the manipulation member .
18. 修复瓣膜的方法，其包括：A method of repairing a valve, comprising:

    在需要所述方法的个体外把已经植入在瓣膜瓣叶上且经一锁钉固定的多根医用线穿过权利要求1至17中任一权利要求所述的医用切线装置，使得所述多根医用线至少部分位于所述医用切线装置的刃口与所述切线配合面之间；A plurality of medical wires, which have been implanted on the valve leaflets and secured by a locking staple, are passed through the medical tangential device of any one of claims 1 to 17 outside the individual in need of the method, so that the A plurality of medical wires are at least partially located between the cutting edge of the medical wire cutting device and the cutting wire mating surface;

    顺着所述医用线的引导，将所述医用切线装置的远端经心脏介入路径向所述瓣膜的瓣叶及所述锁钉移动靠近，直至所述医用切线装置的所述远端到达预定位置；Following the guidance of the medical wire, the distal end of the medical thread cutting device is moved closer to the valve leaflet and the locking pin through the cardiac intervention path, until the distal end of the medical thread cutting device reaches a predetermined distance. Location;

    带动刀片沿轴向向近端移动，把全部所述医用线压在切线配合面上，然后切断所述医用线；以及Drive the blade to move proximally in the axial direction, press all the medical wires on the tangent mating surface, and then cut the medical wires; and

    将所述医用切线装置与多余的所述医用线撤出所述个体外。The medical thread cutting device and the excess medical thread are withdrawn from the outside of the individual.
19. 如权利要求18所述的方法，其中所述个体为人。The method of claim 18, wherein the individual is a human.
20. 如权利要求18或19所述的方法，其中所述瓣膜选自二尖瓣和三尖瓣。19. The method of claim 18 or 19, wherein the valve is selected from the group consisting of a mitral valve and a tricuspid valve.

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