CN114869545A

Movatterモバイル変換

Info

Publication number: CN114869545A
Application number: CN202210345616.7A
Authority: CN
Inventors: 周刚; 徐亚鹏; 虞奇峰; 秦涛
Original assignee: Shanghai Newpulse Medical Technology Co ltd
Current assignee: Shanghai Newpulse Medical Technology Co ltd
Priority date: 2022-03-31
Filing date: 2022-03-31
Publication date: 2022-08-09
Also published as: WO2023185248A1

Abstract

The invention relates to a valve leaflet capturing device, a system and a prosthetic heart valve, wherein the valve leaflet capturing device comprises a capturing ring, the capturing ring is spiral and can be wound around a mitral valve/tricuspid valve chordae tendineae, and the capturing ring comprises a core body, a first wrapping layer and a second wrapping layer from inside to outside; the core is made of preformed memory metal and is used for conforming to the deformation of myocardial tissue; the first wrapping layer is a microporous membrane with a smooth surface and is used for inducing tissue cells to grow inwards; the surface of the second wrapping layer is rough and is used for providing friction force for the artificial heart valve stent implanted in the mitral valve/tricuspid valve. The valve leaf capturing device can be stably matched with an implanted artificial heart valve stent and stably anchored at a proper position, so that mutual displacement of the valve leaf capturing device and the implanted artificial heart valve stent in the cardiac cycle is avoided, and the risk of operation failure is reduced.

Description

Translated fromChinese

一种瓣叶捕获装置、系统及人工心脏瓣膜A valve leaflet capture device, system and artificial heart valve

技术领域technical field

本发明涉及心脏术用医疗器械领域，尤其涉及一种瓣叶捕获装置、系统及人工心脏瓣膜。The invention relates to the field of medical instruments for cardiac surgery, in particular to a valve leaflet capturing device, a system and an artificial heart valve.

背景技术Background technique

心脏包括四个泵腔，分别为左心房和右心房以及左心室和右心室，每个泵腔都具有控制其单向流出的瓣膜。其中位于左心房和左心室之间的是二尖瓣(mitral valve)，心室收缩时，二尖瓣即严密关闭房室口，防止血液逆流入左心房；位于右心房和右心室之间的是三尖瓣(tricuspid valve)，当右心室收缩时，挤压室内血液冲击三尖瓣使其关闭，防止血液倒流入右心房。The heart includes four pumping chambers, the left and right atria and the left and right ventricles, each with valves that control its unidirectional outflow. The mitral valve is located between the left atrium and the left ventricle. When the ventricle contracts, the mitral valve tightly closes the atrioventricular orifice to prevent blood from flowing backward into the left atrium; between the right atrium and the right ventricle is the mitral valve. When the right ventricle contracts, the tricuspid valve closes by squeezing blood in the chamber, preventing backflow of blood into the right atrium.

功能完善的二尖瓣或三尖瓣能够保证在心脏周期中保持正确的血液循环，但是在瓣膜的叶瓣因为疾病而无法达到完全接触(接合)的时候，就会发生二尖瓣反流(MR)或三尖瓣反流(TR)；另一方面，异常的心脏结构也可能是反流的原因，并且这两个过程可因“协同作用”而加速异常的心脏功能。A fully functioning mitral or tricuspid valve ensures proper blood circulation during the heart cycle, but mitral regurgitation occurs when the leaflets of the valve cannot make full contact (coaptation) due to disease ( MR) or tricuspid regurgitation (TR); on the other hand, abnormal heart structures can also be the cause of regurgitation, and these two processes can "act in synergy" to accelerate abnormal heart function.

目前，标准的心脏瓣膜反流治疗的通常需要选择外科手术的方式，标准的外科修复或替换操作需要开心手术、使用心肺旁通术、以及心脏停止术，由于这些外科手术的侵入性质，死亡、中风、出血、呼吸问题、肾脏问题、以及其他并发症都很多见，因此患者往往会因为高风险而拒绝或被判定为不适合进行传统的开放手术。Currently, standard heart valve regurgitation treatment typically requires surgical options. Standard surgical repair or replacement procedures require open-heart surgery, the use of cardiopulmonary bypass, and cardiac arrest. Due to the invasive nature of these surgical procedures, death, Stroke, bleeding, breathing problems, kidney problems, and other complications are so common that patients are often rejected or judged unsuitable for traditional open surgery because of their high risk.

近年来，由于主动脉瓣置换术成功推进，激发了对经导管二尖瓣/三尖瓣置换治疗反流的探索。但是二尖瓣/三尖瓣置换在诸多方面要比主动脉置换困难的多，比如二尖瓣/三尖瓣在空间结构上并非传统的圆形状、二尖瓣/三尖瓣具有更复杂的组织结构(瓣环、瓣叶、腱索、乳头肌)、二尖瓣/三尖瓣要比主动脉大，并且在形状上要更细长、二尖瓣/三尖瓣的瓣叶质地软，相比于主动脉瓣狭窄或钙化，二尖瓣/三尖瓣无法为置换瓣膜提供良好的固位，同时由于当心室收缩时，心室中的压力会急剧上升，如果置换瓣膜未能在二尖瓣/三尖瓣的瓣环处建立足够的锚定则会发生移位风险。因此，有效的进行二尖瓣/三尖瓣置换治疗反流，不仅要承受来自二尖瓣/三尖瓣大的周期性载荷，更重要的是建立稳定和坚固的锚定。In recent years, the successful advancement of aortic valve replacement has stimulated the exploration of transcatheter mitral/tricuspid valve replacement for the treatment of regurgitation. However, mitral/tricuspid valve replacement is much more difficult than aortic valve replacement in many aspects. Tissue structure (annulus, leaflets, chordae tendineae, papillary muscles), mitral/tricuspid valve is larger than aorta and more elongated in shape, mitral/tricuspid valve leaflets are soft , compared with aortic stenosis or calcification, the mitral/tricuspid valve does not provide good retention for the replacement valve, and because the pressure in the ventricle can rise sharply when the ventricle contracts, if the replacement valve fails to There is a risk of displacement if adequate anchoring is established at the annulus of the cuspid/tricuspid valve. Therefore, to effectively perform mitral/tricuspid valve replacement for regurgitation, it is not only necessary to withstand large cyclic loads from the mitral/tricuspid valve, but more importantly, to establish a stable and firm anchor.

为了增强原生瓣叶提供给瓣膜支架的径向支撑力，使瓣膜支架牢固固定在瓣叶处，通常需要在瓣叶的外部的腱索丛处增加一个捕捞环，捕捞环能够将瓣叶和支撑架环抱在一起。但是由于捕捞环的材质较滑，且无法保证其形状与瓣膜支架能够稳定的相互配合，因此在心动周期中捕捞环与瓣膜支架二者可能会发生相互移位，使得置换的瓣膜无法持续稳定的固定在适当的位置，存在发生瓣膜移位的风险。In order to enhance the radial support force provided by the native valve leaflets to the valve stent, so that the valve stent can be firmly fixed at the valve leaflet, it is usually necessary to add a fishing ring at the chordae tendineae outside the valve leaflet. The fishing ring can connect the valve leaflet and support Frames hug together. However, due to the slippery material of the fishing ring and the inability to ensure that the shape of the fishing ring and the valve stent can stably cooperate with each other, the fishing ring and the valve stent may be displaced from each other during the cardiac cycle, making the replacement valve unable to continue stably. Fixed in place, there is a risk of valve displacement.

发明内容SUMMARY OF THE INVENTION

本发明公开了一种瓣叶捕获装置、系统及人工心脏瓣膜，旨在解决现有技术中存在的技术问题。The invention discloses a valve leaflet capturing device, a system and an artificial heart valve, aiming at solving the technical problems existing in the prior art.

本发明采用下述技术方案：The present invention adopts following technical scheme:

一方面，本发明提供了一种瓣叶捕获装置，包括捕捞环：In one aspect, the present invention provides a leaflet capture device, comprising a capture ring:

捕捞环呈螺旋状，能够盘绕于二尖瓣/三尖瓣腱索丛，并定位被植入二尖瓣/三尖瓣内的人工心脏瓣膜支架；The fishing ring is helical and can be coiled around the mitral/tricuspid plexus chordae, and locate the artificial heart valve stent implanted in the mitral/tricuspid valve;

捕捞环由内向外包括芯体、第一包裹层及第二包裹层；The fishing ring includes a core body, a first wrapping layer and a second wrapping layer from the inside to the outside;

芯体由预成形的记忆金属制成，其至少能够在径向和轴向发生弹性形变，以顺应心肌组织形状的改变；The core is made of pre-shaped memory metal, which can elastically deform at least radially and axially to conform to changes in the shape of myocardial tissue;

第一包裹层被配置为具有较小孔隙的纤维层，孔隙的大小允许组织细胞长入，且相邻的孔隙之间相连通以允许细胞长入后产生的细胞外基质相互联接；The first wrapping layer is configured as a fibrous layer with smaller pores, the size of the pores allows tissue cells to grow in, and the adjacent pores are communicated to allow the extracellular matrix generated after the cells grow in to connect with each other;

第二包裹层外表面设有毛面结构，用于为所述捕捞环提供摩擦力；第一包裹层外至少有一处设有第二包裹层；The outer surface of the second wrapping layer is provided with a rough surface structure, which is used to provide friction for the fishing ring; at least one place outside the first wrapping layer is provided with a second wrapping layer;

或者，第二包裹层间隔设置于第一包裹层外。Alternatively, the second wrapping layer is disposed outside the first wrapping layer at intervals.

作为优选的技术方案，第一包裹层自芯体的远端至近端连续覆盖于芯体外。As a preferred technical solution, the first wrapping layer continuously covers the outside of the core from the distal end to the proximal end of the core.

作为优选的技术方案，第一包裹层中孔隙的直径为5-20μm。As a preferred technical solution, the diameter of the pores in the first wrapping layer is 5-20 μm.

作为优选的技术方案，第一包裹层由编织或3D打印制备而成。As a preferred technical solution, the first wrapping layer is prepared by weaving or 3D printing.

作为优选的技术方案，第一包裹层包括ePTFE微孔薄膜。As a preferred technical solution, the first wrapping layer includes an ePTFE microporous film.

作为优选的技术方案，第二包裹层被配置为具有较大孔隙的编织层；As a preferred technical solution, the second wrapping layer is configured as a braided layer with larger pores;

或者，第二包裹层由具备高摩擦系数的高分子材料制成；Alternatively, the second wrapping layer is made of a polymer material with a high coefficient of friction;

或者，第二包裹层由设有图案化镂空的高分子材料制成。Alternatively, the second wrapping layer is made of a polymer material with patterned hollows.

作为优选的技术方案，高分子材料包括PET膜或PTFE膜。As a preferred technical solution, the polymer material includes PET film or PTFE film.

作为优选的技术方案，芯体包括镍钛合金。As a preferred technical solution, the core body includes a nickel-titanium alloy.

作为优选的技术方案，捕捞环由近端至远端依次设置为心房段、过渡段、功能段及心室段；As a preferred technical solution, the fishing ring is sequentially arranged from the proximal end to the distal end into the atrium segment, the transition segment, the functional segment and the ventricular segment;

心房段定位于心房中，并被配置为大致遵循心房壁曲率的弯曲状；the atrial segment is positioned in the atrium and is configured to approximately follow the curvature of the atrial wall;

过渡段被配置为由功能段延伸至位于左心房的心房段。The transition segment is configured to extend from the functional segment to an atrial segment located in the left atrium.

功能段定位于原生瓣环处，呈盘卷状，用于支撑植入的人工心脏瓣膜支架；The functional segment is positioned at the native valve annulus and is coiled to support the implanted artificial heart valve stent;

心室段由功能段延伸心室，并被配置为大致遵循原生腱索丛曲率的弯曲状。The ventricular segment extends the ventricle from the functional segment and is configured to roughly follow the curvature of the native chordae tendineae.

作为优选的技术方案，第二包裹层覆盖于功能段，和/或心房段，和/或过渡段，和/或心室段上与人工心脏瓣膜支架相接触的区域。As a preferred technical solution, the second wrapping layer covers the functional segment, and/or the atrial segment, and/or the transition segment, and/or the ventricular segment on the area in contact with the prosthetic heart valve stent.

作为优选的技术方案，第二包裹层在功能段连续设置。As a preferred technical solution, the second wrapping layer is continuously arranged in the functional section.

作为优选的技术方案除与腱索接触的区域外，第二包裹层间隔覆盖于功能段对应的第一包裹层外。As a preferred technical solution, except for the area in contact with the chordae tendineae, the second wrapping layer covers the first wrapping layer corresponding to the functional segment at intervals.

作为优选的技术方案，捕捞环的近端设有第一连接件，捕捞环的远端设有远端保护件，在捕捞环上还设有至少一个显影环。As a preferred technical solution, the proximal end of the fishing ring is provided with a first connecting piece, the distal end of the fishing ring is provided with a distal protection piece, and at least one developing ring is further provided on the fishing ring.

另一方面，本发明还提供了一种瓣叶捕获系统，包括如上任一项所述的瓣叶捕捞装置，还包括用于递送瓣叶捕获装置的输送装置，输送装置的远端设有第二连接件，第二连接件与所述第一连接件可拆卸连接。In another aspect, the present invention also provides a valve leaflet capture system, comprising the valve leaflet capture device as described in any one of the above, and a delivery device for delivering the valve leaflet capture device, the distal end of the delivery device is provided with a first Two connecting pieces, the second connecting piece is detachably connected with the first connecting piece.

本发明还进一步涉及了一种人工心脏瓣膜，包括如上任一项所述的瓣叶捕获装置，还包括人工心脏瓣膜支架，人工心脏瓣膜支架被配置为在原生二尖瓣/三尖瓣处扩张，并与瓣叶捕获装置相互作用。The present invention still further relates to a prosthetic heart valve, comprising the leaflet capture device of any of the above, and further comprising an artificial heart valve stent, the prosthetic heart valve stent being configured to expand at the native mitral/tricuspid valve , and interacts with the leaflet capture device.

作为优选的技术方案，人工心脏瓣膜支架包括球囊扩张式支架，球囊扩张式支架呈柱形，其外壁上设有密封膜，其内部设置人工瓣叶。As a preferred technical solution, the artificial heart valve stent includes a balloon-expandable stent, and the balloon-expandable stent is cylindrical, with a sealing membrane on its outer wall and artificial valve leaflets inside.

作为优选的技术方案，人工心脏瓣膜支架包括自膨胀式支架，自膨胀式支架包括定位于心房的法兰盘及柱形支架，在自膨胀式支架的外壁上设有密封膜，自膨胀式支架的内部设有人工瓣叶。As a preferred technical solution, the artificial heart valve stent includes a self-expanding stent, the self-expanding stent includes a flange plate and a cylindrical stent positioned at the atrium, a sealing membrane is provided on the outer wall of the self-expanding stent, and the self-expanding stent There are artificial valve leaflets inside.

本发明采用的技术方案能够达到以下有益效果：本发明的捕捞环由内向外分别设置了三层结构，分别为芯体、第一包裹层和第二包裹层。其中的芯体用于定位被植入二尖瓣/三尖瓣的人工心脏瓣膜支架；第一包裹层较光滑，可以诱导组织细胞长入其中，加固捕捞环与二尖瓣/三尖瓣之间的配合关系；第二包裹层设置于捕捞环的外表面，由于其隔着原生二尖瓣/三尖瓣的瓣叶与植入的人工心脏瓣膜支架直接配合，因此选择有高摩擦性能的高分子材料或大孔隙的编织材料，可以提供较大的摩擦力，在一定程度上减少捕捞环的移位风险；第二包裹层的外表面还设置有毛面结构，能够提供一定的缓冲作用，防止因瓣叶与捕捞环之间的摩擦力过大而在心动周期中发生瓣叶撕裂等情况。进一步地，本发明的捕捞环还设置了心房段和心室段，二者分别由原生瓣环处向心房和心室延伸，且具有与心房及原生腱索丛的形状相匹配的弯曲曲率，能够有效的保证捕捞环的固定位置，同时更好地顺应二尖瓣/三尖瓣的正常生理功能。The technical solution adopted in the present invention can achieve the following beneficial effects: the fishing ring of the present invention is provided with three-layer structures from the inside to the outside, which are a core body, a first wrapping layer and a second wrapping layer. The core is used to locate the artificial heart valve stent implanted in the mitral/tricuspid valve; the first wrapping layer is smooth, which can induce tissue cells to grow into it, and strengthen the connection between the fishing ring and the mitral/tricuspid valve. The matching relationship between the two; the second wrapping layer is arranged on the outer surface of the fishing ring, because it directly cooperates with the implanted artificial heart valve stent across the leaflet of the native mitral valve/tricuspid valve, so choose a high friction performance. The polymer material or woven material with large pores can provide greater friction and reduce the displacement risk of the fishing ring to a certain extent; the outer surface of the second wrapping layer is also provided with a rough surface structure, which can provide a certain buffering effect , to prevent the valve leaflet from tearing during the cardiac cycle due to excessive friction between the valve leaflet and the fishing ring. Further, the fishing ring of the present invention is also provided with an atrial segment and a ventricular segment, the two extend from the native valve annulus to the atrium and the ventricle respectively, and have a curvature that matches the shape of the atrium and the native chordae tendineae, which can effectively It ensures the fixed position of the fishing ring while better conforming to the normal physiological function of the mitral/tricuspid valve.

附图说明Description of drawings

为了更清楚地说明本发明实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，构成本发明的一部分，本发明的示意性实施例及其说明解释本发明，并不构成对本发明的不当限定。在附图中：In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the following briefly introduces the accompanying drawings used in the description of the embodiments, which constitute a part of the present invention, and the exemplary embodiments of the present invention and their descriptions explain the present invention. , does not constitute an improper limitation of the present invention. In the attached image:

图1为本发明实施例1公开的一种优选实施方式中捕捞环的剖面结构示意图；1 is a schematic cross-sectional structural diagram of a fishing ring in a preferred embodiment disclosed in Example 1 of the present invention;

图2为本发明实施例1公开的一种优选实施方式中针织绒毛面的PET的展开图；2 is an expanded view of the PET knitted pile surface in a preferred embodiment disclosed in Example 1 of the present invention;

图3为本发明实施例1公开的一种优选实施方式中瓣叶捕获装置的结构示意图；3 is a schematic structural diagram of a valve leaflet capturing device in a preferred embodiment disclosed in Example 1 of the present invention;

图4为本发明实施例1公开的另一种优选实施方式中瓣叶捕获装置的结构示意图；4 is a schematic structural diagram of a valve leaflet capturing device in another preferred embodiment disclosed in Example 1 of the present invention;

图5为本发明实施例1公开的一种优选实施方式中瓣叶捕获装置安置于心脏中的示意图；FIG. 5 is a schematic diagram of the valve leaflet capturing device being placed in the heart in a preferred embodiment disclosed in Example 1 of the present invention;

图6为本发明实施例3公开的人工心脏瓣膜的结构示意图。6 is a schematic structural diagram of the artificial heart valve disclosed in Embodiment 3 of the present invention.

附图标记说明：Description of reference numbers:

捕捞环10，心室段11，功能段12、过渡段13、心房段14，芯体20，第一包裹层30，第二包裹层40，针织绒毛面41，显影环50，第一连接件60，远端保护件70，人工心脏瓣膜支架80，二尖瓣90，左心房100，左心室110。Fishing ring 10,ventricular segment 11,functional segment 12,transition segment 13,atrial segment 14,core 20,first wrapping layer 30,second wrapping layer 40, knittedfleece surface 41, developingring 50,first connector 60 , thedistal protection member 70 , the artificialheart valve stent 80 , themitral valve 90 , theleft atrium 100 , and theleft ventricle 110 .

具体实施方式Detailed ways

为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明具体实施例及相应的附图对本发明技术方案进行清楚、完整地描述。在本发明的描述中，需要说明的是，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。In order to make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in its sense including "and/or" unless the content clearly dictates otherwise.

在本发明的描述中，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发明中的具体含义。In the description of the present invention, it should be noted that the terms "installed", "connected" and "connected" should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood in specific situations.

另外，在本申请的描述中，术语“第一”、“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。In addition, in the description of the present application, the terms "first", "second" and the like are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

如本文所述的，“螺旋状”指的是捕捞环的结构类似于螺旋的弹簧状，但由于其含有多个功能区段，因此并非绝对的/标准的螺旋状；“大致遵循原生腱索丛曲率”指的是捕捞环下段能够和二尖瓣/三尖瓣腱索丛的形状相匹配，以增强其稳定性，而并非其形状与原生二尖瓣/三尖瓣腱索丛曲率完全吻合；“大致遵循心房壁曲率”指的是捕捞环上段能够和心房壁的形状大致匹配，以有效固定捕捞环的位置，而并非其形状与心房壁的形状完全吻合。As used herein, "helical" refers to the spring-like structure of a fishing ring similar to a helix, but is not an absolute/standard helical because it contains multiple functional segments; "approximately follows the native chordae tendineae" "Plexus curvature" refers to the ability of the lower segment of the fishing ring to match the shape of the mitral/tricuspid plexus to enhance its stability, rather than its shape being exactly the curvature of the native mitral/tricuspid plexus Anastomosis; "roughly follow the curvature of the atrial wall" means that the upper segment of the fishing ring can roughly match the shape of the atrial wall to effectively fix the position of the fishing ring, rather than its shape completely matching the shape of the atrial wall.

显然，所描述的实施例仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。Obviously, the described embodiments are only some, but not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

为解决现有技术中存在的问题，本申请实施例提供了一种瓣叶捕获装置、系统及人工心脏瓣膜，其中瓣叶捕获装置包括捕捞环，所述捕捞环呈大致螺旋状，能够盘绕于二尖瓣/三尖瓣腱索丛并定位被植入二尖瓣/三尖瓣内的人工心脏瓣膜支架；所述捕捞环由内向外包括芯体、第一包裹层及第二包裹层；所述芯体由预成形的记忆金属制成，其至少能够在径向和轴向发生弹性形变，以顺应心肌组织形状的改变；所述第一包裹层为表面较光滑的微孔膜，用于诱导组织细胞向内生长；所述第二包裹层表面粗糙，用于为所述捕捞环提供摩擦力。In order to solve the problems existing in the prior art, the embodiments of the present application provide a valve leaflet capture device, a system and an artificial heart valve, wherein the valve leaflet capture device includes a capture ring, and the capture ring is substantially helical and can be coiled around the valve. The mitral valve/tricuspid valve chordae tendineae plexus and positioning the artificial heart valve stent implanted in the mitral valve/tricuspid valve; the fishing ring includes a core body, a first wrapping layer and a second wrapping layer from the inside to the outside; The core body is made of pre-shaped memory metal, which can elastically deform at least in the radial and axial directions, so as to conform to the change of the shape of the myocardial tissue; the first wrapping layer is a microporous membrane with a smooth surface, which is made of For inducing tissue cell ingrowth; the surface of the second coating layer is rough to provide friction for the fishing ring.

实施例1Example 1

以二尖瓣植入为例，本实施例1提供了一种瓣叶捕获装置，以解决现有技术中存在的技术问题。根据图3-图6，瓣叶捕获装置包括捕捞环10，所述捕捞环10大致呈螺旋状，可植入人体二尖瓣的腱索丛处，并提供轴向和径向的作用力，以配合植入二尖瓣内的人工心脏瓣膜支架并与其相互作用，二者的配合能够减小天然二尖瓣的尺寸、减少天然瓣膜小叶的二尖瓣反流，同时瓣叶捕获装置可以更紧固的锚定植入的人工心脏瓣膜支架80的位置，有效避免人工心脏瓣膜在心肌运动过程中发生移位。Taking mitral valve implantation as an example, Embodiment 1 provides a valve leaflet capturing device to solve the technical problems existing in the prior art. According to FIGS. 3-6 , the valve leaflet capture device includes acapture ring 10 , which is substantially helical and can be implanted at the chordae tendineae of the human mitral valve, and provides axial and radial forces, To cooperate with and interact with the prosthetic heart valve stent implanted in the mitral valve, the cooperation of the two can reduce the size of the native mitral valve, reduce mitral valve regurgitation of the native valve leaflets, and the valve leaflet capture device can be more The position of the implanted artificialheart valve stent 80 is firmly anchored to effectively avoid displacement of the artificial heart valve during myocardial movement.

根据图3及图4所示，上述瓣叶捕获装置包括捕捞环10、设置于捕捞环10近端的第一连接件60、设置于捕捞环10远端的远端保护件70，以及布置于捕捞环10上的多个显影环50。其中第一连接件60用于与递送所述瓣叶捕获装置的输送装置可拆卸连接；远端保护件70用于在瓣叶捕获装置的递送过程中保护心肌组织；显影环50用于观察与确定捕捞环10在手术过程中的位置，并提示其从心房侧至心室侧的移动，捕捞环10环抱于二尖瓣腱索丛外，用于定位植入二尖瓣内的人工心脏瓣膜支架80。As shown in FIGS. 3 and 4 , the valve leaflet capturing device includes afishing ring 10 , a first connectingmember 60 disposed at the proximal end of thefishing ring 10 , adistal protection member 70 disposed at the distal end of thefishing ring 10 , and a The plurality of developingrings 50 on thefishing ring 10. Thefirst connector 60 is used for detachable connection with the delivery device for delivering the valve leaflet capture device; thedistal protection member 70 is used to protect myocardial tissue during the delivery process of the valve leaflet capture device; the developingring 50 is used to observe and The position of thefishing ring 10 during the operation is determined, and its movement from the atrium side to the ventricular side is indicated. Thefishing ring 10 is surrounded by the mitral valve chordae tendineae and used to locate the artificial heart valve stent implanted in the mitral valve. 80.

优选的，为了将瓣叶捕获装置更加稳定的固定于二尖瓣处，捕捞环10由近端向远端依次设置有心房段14、过渡段13、功能段12及心室段11，其中：Preferably, in order to more stably fix the valve leaflet capturing device at the mitral valve, the capturingring 10 is sequentially provided with anatrium segment 14, atransition segment 13, afunctional segment 12 and aventricular segment 11 from the proximal end to the distal end, wherein:

心房段14弯曲盘绕于左心房100中，且其弯曲的曲率与心房壁的曲率大致相同，以保证捕捞环10的心房段14可以与左心房100更加匹配，进一步地，对于不同的患者，其心房的形状、尺寸会有所不同，本领域技术人员可以理解的是，心房段14的具体弯曲曲率及尺寸可以根据患者的情况而适应性的改变，在一种优选实施方式中，在对不同的患者进行手术前，可以通过影像学的方法对患者的心脏进行建模，以确定捕捞环10合适的形状与尺寸。Theatrial segment 14 is curved and coiled in theleft atrium 100, and the curvature of its curvature is approximately the same as the curvature of the atrial wall, so as to ensure that theatrial segment 14 of thefishing ring 10 can be more matched with theleft atrium 100, and further, for different patients, its The shape and size of the atrium will be different. Those skilled in the art can understand that the specific curvature and size of theatrial segment 14 can be adaptively changed according to the situation of the patient. Before the operation of the patient of 100,000, the patient's heart can be modeled by means of imaging, so as to determine the appropriate shape and size of thefishing ring 10.

参考图5，功能段12呈盘卷状定位于原生二尖瓣的瓣环处，用于支撑被植入二尖瓣内的人工心脏瓣膜支架80。Referring to FIG. 5 , thefunctional segment 12 is positioned at the valve annulus of the native mitral valve in a coil shape, and is used to support the artificialheart valve stent 80 implanted in the mitral valve.

优选的，过渡段13设置于心房段14与功能段12之间，其形状被配置为由功能段12延伸至位于左心房100的心房段14，由于功能段12设置于二尖瓣外，心房段14定位于左心房100内，因此捕捞环10在置入体内后过渡段13由二尖瓣外穿过瓣叶间隙螺旋上升，并延伸至心房段14。Preferably, thetransition section 13 is disposed between theatrial section 14 and thefunctional section 12, and its shape is configured to extend from thefunctional section 12 to theatrial section 14 located in theleft atrium 100. Since thefunctional section 12 is disposed outside the mitral valve, theatrial Segment 14 is positioned withinleft atrium 100 so thattransition segment 13 spirals up from outside the mitral valve through the leaflet space and extends toatrial segment 14 after thecapture ring 10 is implanted.

心室段11由上述功能段12向下延伸至并接合至左心室110，并被配置为大致遵循原生二尖瓣腱索丛曲率的弯曲状，如图5所示。进一步地，由于心室段11和功能段12均位于二尖瓣外，因此无需再设置过渡段13；优选的，心室段11的具体尺寸及曲率可以根据患者的具体情况做出适应性改变。Theventricular segment 11 extends downwardly from thefunctional segment 12 described above to and joins theleft ventricle 110 and is configured to generally follow the curvature of the native mitral valve chordae tendineae curvature, as shown in FIG. 5 . Further, since both theventricular segment 11 and thefunctional segment 12 are located outside the mitral valve, thetransition segment 13 does not need to be provided; preferably, the specific size and curvature of theventricular segment 11 can be adapted according to the specific conditions of the patient.

进一步地，由于心房段14定位于心房中，而功能段12及心室段11放置于二尖瓣外，因此心房段14用于提供径向向外扩张的力，以保证该段可以稳定的定位于左心房100中，而功能段12及心室段11则提供径向向内收紧的力，以锚定位于二尖瓣内的人工心脏瓣膜支架80，以同时对人工心脏瓣膜支架80和自身进行固定，同时也可以对二尖瓣进行收紧，以减少二尖瓣反流。Further, since theatrial segment 14 is positioned in the atrium, and thefunctional segment 12 and theventricular segment 11 are placed outside the mitral valve, theatrial segment 14 is used to provide radial outward expansion force to ensure that the segment can be positioned stably In theleft atrium 100, thefunctional segment 12 and theventricular segment 11 provide radially inward tightening forces to anchor the prostheticheart valve stent 80 within the mitral valve to simultaneously compress the prostheticheart valve stent 80 and itself. Immobilization and mitral valve tightening may also be performed to reduce mitral regurgitation.

更进一步的，呈大致螺旋状的捕捞环10还可以提供轴向变形能力，以顺应左心心肌组织在整个心动周期中形态的改变，同时在进行手术置入时也更加便利。Furthermore, the substantiallyhelical fishing ring 10 can also provide axial deformability, so as to conform to the morphological changes of the left heart myocardium throughout the cardiac cycle, and at the same time, it is more convenient for surgical placement.

由于心房的空间较大，二尖瓣瓣环处最狭窄，二尖瓣下的腱索丛逐渐扩张，因此在一种优选实施例中，在捕捞环10的多个区段中，功能段12的直径小于心室段11的直径，心室段11的直径小于心房段14的直径，以期获得最佳的固定位点。在其他实施例中，若术前对患者的心脏进行影像学检查后发现上述实施例中的比例关系不适用，则可以根据实际情况选择更加合适的尺寸及比例。Due to the large space of the atrium, the mitral valve annulus is the narrowest, and the chordae tendineae under the mitral valve gradually expands, so in a preferred embodiment, among the multiple segments of thefishing ring 10, thefunctional segment 12 The diameter of theventricular segment 11 is smaller than the diameter of theventricular segment 11, which is smaller than the diameter of theatrial segment 14, in order to obtain the best fixation site. In other embodiments, if it is found that the proportional relationship in the above embodiment is not applicable after the preoperative imaging examination of the patient's heart, a more appropriate size and ratio may be selected according to the actual situation.

根据图1所显示的上述捕捞环10的横切面，其结构由内向外包括三层：芯体20、第一包裹层30和第二包裹层40。According to the cross-section of the above-mentionedfishing ring 10 shown in FIG. 1 , its structure includes three layers from the inside to the outside: thecore body 20 , thefirst wrapping layer 30 and thesecond wrapping layer 40 .

上述芯体20由至少一根弹性丝螺旋盘绕而成，并且其至少具有径向和轴向变形的能力，能够顺应二尖瓣形状的改变，并支撑和定位被植入二尖瓣内的人工心脏瓣膜支架80；优选的，由于芯体20不直接与心肌组织接触，因此无需一定选择生物相容性材料，具体可以选择记忆合金、聚合物、纤维或其他高分子材料，在一种优选实施方式中，所述芯体20优选为记忆合金热定型而成，更进一步的优选为镍钛合金，由于镍钛合金具备20％以上的伸缩率，且具有高阻尼、高弹性和高疲劳寿命，因此无论是在向人体递送过程中亦或是植入后都能保持稳定的形状，更重要的是，如果芯体20外的第一包裹层30及第二包裹层40受损，芯体20有可能会直接与心肌组织接触，而镍钛合金作为生物相容性材料会更加安全，及具备耐磨和抗腐蚀的性能，还不会产生排异反应。The above-mentionedcore body 20 is made of at least one elastic wire spirally coiled, and at least has the ability of radial and axial deformation, can adapt to the change of the shape of the mitral valve, and support and position the artificial valve implanted in the mitral valve.Heart valve stent 80; preferably, since thecore 20 is not in direct contact with myocardial tissue, there is no need to select biocompatible materials, specifically memory alloys, polymers, fibers or other polymer materials can be selected. In a preferred implementation In the method, thecore body 20 is preferably made of memory alloy by heat-setting, and is more preferably a nickel-titanium alloy. Since the nickel-titanium alloy has a stretch rate of more than 20%, and has high damping, high elasticity and high fatigue life, Therefore, it can maintain a stable shape during delivery to the human body or after implantation. More importantly, if thefirst wrapping layer 30 and thesecond wrapping layer 40 outside thecore body 20 are damaged, thecore body 20 There is a possibility of direct contact with myocardial tissue, and Nitinol is safer as a biocompatible material, and has wear and corrosion resistance properties without rejection.

上述第一包裹层30表面较光滑，可以诱导心肌组织向内生长，以此来进一步加固捕捞环10与二尖瓣的配合关系；优选的，在第一包裹层30表面和层体结构中都遍布有较小的孔隙，孔隙的大小应设置为允许组织细胞长入，在一种优选实施例中，孔隙的直径为5-20μm，以满足单个细胞能够通过，进一步地，在第一包裹层30的层体结构中设置的孔隙之间均互相连通，以允许组织细胞长入后产生的细胞外基质相互联接。The surface of the above-mentionedfirst wrapping layer 30 is relatively smooth, which can induce the ingrowth of myocardial tissue, so as to further strengthen the matching relationship between thefishing ring 10 and the mitral valve; There are smaller pores throughout, and the size of the pores should be set to allow tissue cells to grow in. In a preferred embodiment, the diameter of the pores is 5-20 μm, so that a single cell can pass through. Further, in the first wrapping layer The pores provided in the layered structure of 30 are all connected with each other, so as to allow the extracellular matrix produced after the ingrowth of tissue cells to connect with each other.

在一种优选实施方式中，第一包裹层30可通过编织、3D打印、静电纺丝、激光蚀刻能方式制备；当采用编织、静电纺丝等工艺时，需要保证使用的材料具备一定的弹性，以避免其跟随芯体20收缩或扩张发生撕裂或破损；当采用3D打印、激光蚀刻等工艺时，需第一包裹层30的内径应略小于芯体20的外径，使得二者能够过盈配合，以期获得更稳定的组合结构。In a preferred embodiment, thefirst wrapping layer 30 can be prepared by weaving, 3D printing, electrospinning, or laser etching. , to avoid tearing or damage following the shrinkage or expansion of the core 20; when using 3D printing, laser etching and other processes, the inner diameter of thefirst wrapping layer 30 should be slightly smaller than the outer diameter of the core 20, so that the two can be Interference fit in order to obtain a more stable combined structure.

在一种优选实施方式中，第一包裹层30可以选择光滑致密的高分子材料制作，优选聚氨酯、聚四氟乙烯、膨体聚四氟乙烯、海藻酸/海藻酸盐、蚕丝蛋白、甲壳素、明胶、胶原、透明质酸、壳聚糖、聚己内酯、聚乳酸、聚对苯二甲酸乙二醇酯、聚乙烯、聚氯乙烯、聚羟基乙酸、聚甲基丙烯酸、聚乳酸-聚羟基乙酸、羧甲基淀粉、醋酸淀粉、羧甲基壳聚糖、羧甲基纤维素、聚乙烯醇、聚丙烯酰胺、聚丙烯酸和聚乙烯吡咯烷酮等材料；在一种更优选的实施方式中，第一包裹层30选择使用膨体聚四氟乙烯(ePTFE)微孔薄膜进行制作，由于ePTFE微孔薄膜是以聚四氟乙烯为原料经膨化拉伸形成的薄膜，本身已经具有无数个微孔便于细胞进入，无须再通过编织或3D打印的方式制作孔隙，而且其体量轻，在置入二尖瓣后不会额外增加负担。In a preferred embodiment, thefirst wrapping layer 30 can be made of a smooth and dense polymer material, preferably polyurethane, polytetrafluoroethylene, expanded polytetrafluoroethylene, alginic acid/alginate, silk protein, chitin , gelatin, collagen, hyaluronic acid, chitosan, polycaprolactone, polylactic acid, polyethylene terephthalate, polyethylene, polyvinyl chloride, polyglycolic acid, polymethacrylic acid, polylactic acid- Materials such as polyglycolic acid, carboxymethyl starch, starch acetate, carboxymethyl chitosan, carboxymethyl cellulose, polyvinyl alcohol, polyacrylamide, polyacrylic acid and polyvinylpyrrolidone; in a more preferred embodiment Among them, thefirst wrapping layer 30 is made of expanded polytetrafluoroethylene (ePTFE) microporous film. Since the ePTFE microporous film is a film formed by expanding and stretching polytetrafluoroethylene as a raw material, it already has numerous The micropores are easy for cells to enter, and there is no need to make pores by weaving or 3D printing. Moreover, it is light in weight and will not add extra burden after the mitral valve is placed.

上述第二包裹层40表面较为粗糙，用于为捕捞环10提供一定的摩擦力，降低捕捞环10在心动周期中发生位移的风险；优选的，第二包裹层40的材料可选择具有较大孔隙的编织材料、具备高摩擦系数的高分子材料或者设有图案化镂空的高分子材料；优选的，可以选择PTFE作为制作第二包裹层40的材料；更优选的，由于PET膜具备拉伸强度大、厚度薄、摩擦系数高、表面张力大等特点，因此选择PET膜作为第二包裹层40的制作材料；在一种更优选的实施方式中，在设置PET膜时预先将其表面设置图案化镂空，如条纹型图案、波点状图案、锯齿线状图案或其他图案，以进一步提高其摩擦性能。The surface of thesecond wrapping layer 40 is relatively rough, which is used to provide a certain frictional force for thefishing ring 10 and reduce the risk of displacement of thefishing ring 10 during the cardiac cycle; The woven material with pores, the polymer material with high friction coefficient, or the polymer material with patterned hollows; preferably, PTFE can be selected as the material for making thesecond wrapping layer 40; Due to the characteristics of high strength, thin thickness, high friction coefficient, and large surface tension, PET film is selected as the material for making thesecond wrapping layer 40; in a more preferred embodiment, the surface of the PET film is set in advance when setting Patterned cutouts, such as stripes, polka dots, zigzag lines, or other patterns, to further improve their friction properties.

如果第二包裹层40与瓣叶之间的摩擦力过大，则瓣叶有可能在心动周期中发生撕裂等情况，为了避免或减少这种事情的发生，在一种更优选的实施方式中，在第二包裹层40的外表面还设有疏松排列的毛面结构，以提供一定的缓冲作用，防止捕捞环10在心动周期中对瓣叶造成撕裂。具体在选择第二包裹层40的材料时，可以选择附有针织绒毛面41的PET膜，如图1-2，在保证一定柔韧性的同时亦能起到缓冲的作用，以取得保护瓣叶与定位人工心脏瓣膜支架80间的平衡。If the frictional force between thesecond wrapping layer 40 and the valve leaflets is too large, the valve leaflets may be torn during the cardiac cycle. In order to avoid or reduce the occurrence of such things, in a more preferred embodiment Among them, the outer surface of thesecond wrapping layer 40 is also provided with a loosely arranged rough surface structure to provide a certain buffering effect and prevent the catchingring 10 from tearing the valve leaflets during the cardiac cycle. Specifically, when selecting the material of thesecond wrapping layer 40, a PET film with aknitted fluff surface 41 can be selected, as shown in Figure 1-2, which can ensure a certain flexibility and also play a buffering role to protect the valve leaflets. Balance with positioning the prostheticheart valve stent 80 .

在一种实施方式中，第二包裹层40连续覆盖于第一包裹层30外；优选的，由于捕捞环10只有功能段12与人工心脏瓣膜支架80接触，因此仅在捕捞环10的功能段12设置第二包裹层40，如图3；在一种更优选的实施方式中，在植入人工心脏瓣膜支架80后，捕捞环10的功能段12无法和支架完全匹配，而仅有部分区域相互接触，因此仅在捕捞环10功能段12与人工心脏瓣膜支架80相接触的区域间隔覆盖第二包裹层40即可，如图4；同时为了防止捕捞环10在心动周期中发生局部的移位，因此在设置第二包裹层40时可稍大于捕捞环10与人工心脏瓣膜支架80的接触面积。In one embodiment, thesecond wrapping layer 40 continuously covers the outside of thefirst wrapping layer 30; preferably, since only thefunctional section 12 of thefishing ring 10 is in contact with the artificialheart valve stent 80, only the functional section of thefishing ring 10 is in contact with the artificialheart valve stent 80. 12. Set thesecond wrapping layer 40, as shown in FIG. 3; in a more preferred embodiment, after implanting the artificialheart valve stent 80, thefunctional section 12 of thefishing ring 10 cannot be completely matched with the stent, but only a partial area Therefore, thesecond wrapping layer 40 can be covered only in the area where thefunctional section 12 of thefishing ring 10 is in contact with the artificialheart valve stent 80, as shown in FIG. 4; at the same time, in order to prevent the local displacement of thefishing ring 10 during the cardiac cycle Therefore, when thesecond wrapping layer 40 is provided, the contact area between thefishing ring 10 and the artificialheart valve stent 80 may be slightly larger.

在另外一种优选实施方式中，第二包裹层40在功能段12间隔设置，但与腱索接触的功能段12的部分区域不设置第二包裹层40，避免在植入捕捞环10的过程中压迫或摩擦腱索，避免因摩擦力过大而产生剪切力，造成腱索断裂。更优选地，在功能段12中，第二包裹层40在近心房段14处的分布密度大于近心室段11处的分布密度，在保证减小瓣周漏的同时降低对腱索的损伤，可选的，第二包裹层40在功能段12靠近瓣环的区域连续设置，而后间隔设置，且越靠近心室段11间隔越大，直至靠近腱索区域不再设置第二包裹层40。在一种更优选的实施方式中，在功能段12靠近瓣膜联合处的区域连续设置第二包裹层40，其他区域不再设置第二包裹层40，或间隔设置第二包裹层40。In another preferred embodiment, thesecond wrapping layer 40 is provided at intervals in thefunctional segment 12, but thesecond wrapping layer 40 is not provided in the part of thefunctional segment 12 in contact with the chordae tendineae to avoid the process of implanting thefishing ring 10 Press or rub the chordae tendineae in the middle to avoid shearing force due to excessive friction, resulting in rupture of the chordae tendineae. More preferably, in thefunctional segment 12, the distribution density of thesecond wrapping layer 40 at the proximalatrial segment 14 is greater than the distribution density at theproximal ventricular segment 11, so as to reduce the damage to the chordae tendineae while ensuring the reduction of paravalvular leakage, Optionally, thesecond wrapping layer 40 is continuously arranged in the region of thefunctional segment 12 close to the valve annulus, and then spaced apart, and the closer to theventricular segment 11, the greater the interval, until thesecond wrapping layer 40 is no longer placed near the chordae tendineae region. In a more preferred embodiment, thesecond wrapping layer 40 is continuously provided in the region of thefunctional segment 12 near the valve commissure, and thesecond wrapping layer 40 is not provided in other regions, or thesecond wrapping layer 40 is provided at intervals.

进一步地，在手术过程中，将瓣叶捕获装置递送到二尖瓣位置时，医生需要通过设置于捕捞环10上的显影环50来确定安置的位置是否准确，而且，由于心脏瓣膜是立体结构，通常需要确定其空间位置是否准确，因此需要通过多个显影环50的位置判断其空间位置是否准确。为了便于植入过程中瓣叶捕获装置的空间位置的确定，上述显影环50设置于捕捞环10过渡段13的上下两端，用于在手术过程中提示捕捞环10从左心房100侧向左心室110侧位置的移动；优选的，显影环50可以是任何生物相容性金属或是有显影性的高分子材料，优选为镍钛、不锈钢或添加有硫酸钡的注塑件；具体的，显影环50可以通过胶水粘接或缝合的方式固定于捕捞环10上。Further, during the operation, when the valve leaflet capture device is delivered to the mitral valve position, the doctor needs to determine whether the placement position is accurate through theimaging ring 50 provided on thecapture ring 10, and since the heart valve is a three-dimensional structure , it is usually necessary to determine whether its spatial position is accurate, so it is necessary to judge whether its spatial position is accurate through the positions of the plurality of developing rings 50 . In order to facilitate the determination of the spatial position of the valve leaflet capture device during the implantation process, the above-mentioned developingring 50 is arranged at the upper and lower ends of thetransition section 13 of thecapture ring 10 to prompt thecapture ring 10 to move from theleft atrium 100 side to the left during the operation. The movement of the side position of theventricle 110; preferably, the developingring 50 can be any biocompatible metal or a developing polymer material, preferably nickel-titanium, stainless steel or an injection-molded part added with barium sulfate; Thering 50 can be fixed on thefishing ring 10 by means of gluing or sewing.

优选的，上述远端保护件70为半球状固接于捕捞环10的远端，其材料可以是任何生物相容性金属或是有显影性的高分子材料，可以选择使用和显影环50相同的材料。Preferably, the above-mentioneddistal protection member 70 is hemispherically fixed to the distal end of thefishing ring 10 , and its material can be any biocompatible metal or a developing polymer material, which can be selected to be the same as the developingring 50 . s material.

优选的，上述第一连接件60为与递送所述瓣叶捕获装置的输送装置的远端互为卡接结构，用于对捕捞环10递送过程中的限位及释放。Preferably, the above-mentioned first connectingmember 60 is a structure of mutual engagement with the distal end of the delivery device for delivering the valve leaflet capturing device, so as to limit and release the capturingring 10 during the delivery process.

在本实施例中，上述瓣叶捕获装置在使用时，通过输送装置将捕捞环10释放于二尖瓣腱索丛处后，其功能段12定位于原生二尖瓣的瓣环处，过渡段13由瓣环处穿过瓣叶间隙向上延伸，心房段14具有径向扩张的力，以防止瓣叶捕获装置发生移位，心室段11由功能段12向下延伸，并环抱于二尖瓣腱索丛处，心室段11与功能段12均具有径向收紧的力，进一步加强对瓣叶捕获装置的定位。进一步地，将人工心脏瓣膜支架80植入原生二尖瓣内，支架径向向外扩张，与径向收紧的功能段12相互作用，以锚定支架以防止其移位。由于捕捞环10具有三层结构，其中包裹于芯体20外的第一包裹层30质地紧密光滑且遍布孔隙，能够诱导组织细胞向其中生长，加强芯体20的锚定作用；最外层的第二包裹层40直接与支架接触，其外表面还设有毛面结构，不仅可以防止捕捞环10发生移位，还提供了一定的缓冲，避免撕裂瓣叶，使得二尖瓣的瓣叶与瓣叶捕获装置的配合更加安全和稳定。In this embodiment, when the above-mentioned valve leaflet capture device is in use, after thecapture ring 10 is released at the mitral valve chordae tendineae through the delivery device, thefunctional section 12 is positioned at the valve annulus of the native mitral valve, and thetransition section 13 extends upward from the valve annulus through the leaflet gap, theatrial segment 14 has radial expansion force to prevent displacement of the valve leaflet capture device, and theventricular segment 11 extends downward from thefunctional segment 12 and embraces the mitral valve At the chordae tendineae, both theventricular segment 11 and thefunctional segment 12 have radial tightening forces, which further enhances the positioning of the valve leaflet capture device. Further, the prostheticheart valve stent 80 is implanted in the native mitral valve, and the stent expands radially outward to interact with the radially tightenedfunctional segment 12 to anchor the stent to prevent its displacement. Because thefishing ring 10 has a three-layer structure, thefirst wrapping layer 30 wrapped around thecore body 20 is compact and smooth in texture and spreads all over the pores, which can induce tissue cells to grow therein and strengthen the anchoring effect of thecore body 20; Thesecond wrapping layer 40 is in direct contact with the stent, and the outer surface of thesecond wrapping layer 40 is also provided with a rough surface structure, which not only prevents the displacement of thefishing ring 10, but also provides a certain buffer to avoid tearing the valve leaflets, so that the valve leaflets of the mitral valve are The fit with the leaflet capture device is more secure and stable.

实施例2Example 2

实施例2提供了一种瓣叶捕获系统，本实施例在实施例1结构的基础上，还增加了用于递送瓣叶捕获装置的输送装置，在该输送装置的远端设有第二连接件，用于和捕捞环10近端的第一连接件60可拆卸连接，输送装置的第二连接件与捕捞环10一同穿过导引导管到达左心预定位置，并释放捕捞环10。Embodiment 2 provides a valve leaflet capture system. On the basis of the structure of Embodiment 1, this embodiment also adds a delivery device for delivering the valve leaflet capture device, and a second connection is provided at the distal end of the delivery device. The second connector of the conveying device and thefishing ring 10 pass through the guide tube to a predetermined position of the left heart, and release thefishing ring 10.

实施例3Example 3

仍以二尖瓣植入为例，参考图6，实施例3提供了一种人工心脏瓣膜，本实施例在实施例1的结构基础上，还包括了人工心脏瓣膜支架80，如实施例1中所述，人工心脏瓣膜支架80被配置为在原生二尖瓣处扩张，并与上述瓣叶捕获装置相互作用，以消除二尖瓣反流。人工心脏瓣膜支架80可以是球囊扩张式支架或者自膨胀式支架，支架外壁上设有密封膜，内部设置人工瓣叶。Still taking the implantation of the mitral valve as an example, referring to FIG. 6 , Embodiment 3 provides an artificial heart valve. On the basis of the structure of Embodiment 1, this embodiment also includes an artificialheart valve stent 80 , as shown in Embodiment 1. As described in, the prostheticheart valve stent 80 is configured to expand at the native mitral valve and interact with the leaflet capture device described above to eliminate mitral regurgitation. The artificialheart valve stent 80 may be a balloon-expandable stent or a self-expanding stent, a sealing membrane is provided on the outer wall of the stent, and artificial valve leaflets are provided inside.

具体地，人工心脏瓣膜支架80固定于原生二尖瓣处，并具体被捕捞环10的功能段12所锚定，捕捞环10的心房段14固定于左心房100中，心室段11环抱于二尖瓣腱索丛处。Specifically, the artificialheart valve stent 80 is fixed at the native mitral valve, and is specifically anchored by thefunctional segment 12 of thefishing ring 10, theatrial segment 14 of thefishing ring 10 is fixed in theleft atrium 100, and theventricular segment 11 is surrounded by the two at the cusps chordae tendineae.

上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，均属于本发明的保护之内。The embodiments of the present invention have been described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific embodiments, which are merely illustrative rather than restrictive. Under the inspiration of the present invention, without departing from the spirit of the present invention and the scope protected by the claims, many forms can be made, which all belong to the protection of the present invention.