技术领域technical field
本发明涉及一种人体内的组织修复器械，更具体地说，涉及一种心脏瓣膜夹持装置。The invention relates to a tissue repair instrument in a human body, more specifically, to a heart valve clamping device.
背景技术Background technique
二尖瓣回流的特征在于血液从心脏的左心室经过机能不全的二尖瓣逆流入左心房。在心脏收缩(收缩期)的正常循环的过程中，二尖瓣用作止回阀，以防止含氧血液流回左心房。以这种方式，含氧血液通过主动脉瓣泵入主动脉。瓣膜回流可显著降低心脏的泵送效率，使患者处于严重、进行性心脏衰竭的风险之中。Mitral regurgitation is characterized by the reverse flow of blood from the left ventricle of the heart into the left atrium through the incompetent mitral valve. During the normal cycle of heart contraction (systole), the mitral valve acts as a check valve to prevent oxygenated blood from flowing back into the left atrium. In this way, oxygenated blood is pumped through the aortic valve into the aorta. Valve regurgitation can significantly reduce the heart's pumping efficiency, putting patients at risk for severe, progressive heart failure.
二尖瓣回流的最常见的治疗依赖于瓣膜置换或修复，包括瓣叶和瓣环的重塑，后者通常被称为瓣环成形术。二尖瓣修复依赖于将相对瓣叶的相邻节段缝合在一起的最新技术，被称为“领结”或“边对边”技术。这些技术通常依赖于开放式心脏手术，其中患者的胸部通常通过胸骨切开术被打开，并且患者被置于心肺分流。最近，基于微创导管手术已经发展到将植入夹递送到机能不全的瓣膜。这些夹用于将瓣叶的部分固定在一起，将两个二尖瓣之间的间隙分隔成相邻的两个较小的间隙，从而减小回流。The most common treatment for mitral regurgitation relies on valve replacement or repair, including remodeling of the leaflets and annulus, the latter commonly referred to as annuloplasty. Mitral valve repair relies on the latest technique of suturing adjacent segments of opposing leaflets together, known as the "bow tie" or "edge-to-edge" technique. These techniques typically rely on open heart surgery, in which the patient's chest is opened, usually via a sternotomy, and the patient is placed on cardiopulmonary bypass. More recently, minimally invasive catheter-based procedures have been developed to deliver implanted clips to incompetent valves. These clips are used to hold parts of the leaflets together, dividing the space between the two mitral valves into two adjacent smaller spaces, thereby reducing backflow.
如图1、图2所示，固定装置通常包括近侧元件16(或抓持元件)和远侧元件18(或固定元件)，近侧元件16的自由端朝着远侧元件18自由端附近的接合表面倾斜，可以朝着轴12向内运动并通过近侧元件线90的帮助贴靠轴12保持。近侧元件16通过操纵近侧元件线90升高和降低。图1为将固定装置输送到心脏中的打开位置，即趋近二尖瓣后先将远侧元件18打开，用近侧元件线90保持近侧元件靠近轴12设置，如图2所示，当二尖瓣位于近端元件以及远端元件之间时，释放近侧元件线90使近侧元件16朝向远侧元件18运动，以便将瓣叶捕捉或保持在其之间。可以知道，该现有技术中实现将二尖瓣夹持于近侧元件16以及远侧元件18之间时，需要依次控制近侧元件16以及远侧元件18，并且近侧元件16的运动需要通过近侧元件线90的配合，导致器械结构复杂，可靠性不足，操作不方便。As shown in Figures 1 and 2, the fixation device generally includes a proximal element 16 (or grasping element) and a distal element 18 (or a fixation element), and the free end of the proximal element 16 is near the free end of the distal element 18. The engaging surface of the slant can be moved inwardly towards the shaft 12 and held against the shaft 12 with the help of the proximal element wire 90 . Proximal element 16 is raised and lowered by manipulating proximal element wire 90 . Fig. 1 is the opening position for delivering the fixation device to the heart, that is, after approaching the mitral valve, the distal element 18 is opened first, and the proximal element line 90 is used to keep the proximal element positioned close to the shaft 12, as shown in Fig. 2 , When the mitral valve is positioned between the proximal and distal elements, releasing the proximal element wire 90 moves the proximal element 16 toward the distal element 18 to capture or retain the leaflets therebetween. It can be known that when the mitral valve is clamped between the proximal element 16 and the distal element 18 in the prior art, the proximal element 16 and the distal element 18 need to be controlled sequentially, and the movement of the proximal element 16 requires Through the cooperation of the proximal component wire 90, the structure of the instrument is complicated, the reliability is insufficient, and the operation is inconvenient.
发明内容Contents of the invention
本发明要解决的技术问题在于，针对现有技术的二尖瓣修复装置结构复杂，操作不便的缺陷，提供一种可避免上述缺陷的瓣膜夹持装置。The technical problem to be solved by the present invention is to provide a valve clamping device which can avoid the defects of the mitral valve repair device in the prior art, which are complicated in structure and inconvenient to operate.
本发明解决其技术问题所采用的技术方案是：The technical solution adopted by the present invention to solve its technical problems is:
一种瓣膜夹持装置，其包括：支撑部，所述支撑部具有第一端；主体部，所述主体部一端与所述第一端相连，另一端围绕所述支撑部；及夹持部,所述夹持部围设于所述主体部的外侧，且可相对所述主体部以所述第一端为中心呈辐射状展开或闭合。A valve clamping device, comprising: a support part, the support part has a first end; a main body part, one end of the main body part is connected to the first end, and the other end surrounds the support part; and a clamping part , the clamping portion is arranged around the outer side of the main body, and can be radially expanded or closed relative to the main body with the first end as the center.
在本发明一个实施例中,所述主体部为网状结构。In one embodiment of the present invention, the main body is a mesh structure.
在本发明一个实施例中,所述网状结构上设有加强网管。In one embodiment of the present invention, the network structure is provided with reinforced network pipes.
在本发明一个实施例中,所述主体部为硅胶体或者海绵体。In one embodiment of the present invention, the main body is silicon colloid or sponge.
在本发明一个实施例中,所述夹持部靠近所述主体部的一侧设有至少一个锚定件，所述主体部设有定位孔或定位槽，在所述夹持部闭合状态下，所述锚定件嵌置于与之配对的所述定位孔或定位槽中。In one embodiment of the present invention, at least one anchor is provided on the side of the clamping portion close to the main body, and the main body is provided with a positioning hole or a positioning groove. When the clamping portion is closed , the anchor piece is embedded in the positioning hole or the positioning groove matched therewith.
在本发明一个实施例中,所述夹持部设有多个锚定件,且至少一个锚定件为锯齿状结构。In one embodiment of the present invention, the clamping portion is provided with a plurality of anchor pieces, and at least one anchor piece has a sawtooth structure.
在本发明一个实施例中,所述夹持部包括两个分别位于所述主体部相对两侧的夹持件,且两个所述夹持件在靠近所述第一端的端部相互转动连接。In one embodiment of the present invention, the clamping portion includes two clamping pieces respectively located on opposite sides of the main body portion, and the two clamping pieces are mutually rotated at the ends close to the first end connect.
在本发明一个实施例中,所述瓣膜夹持装置还包括一个驱动部,所述驱动部包括一个闭合单元和一个打开单元；所述闭合单元至少部分位于所述夹持部的内部,且与所述夹持部相连,用于使所述夹持部在自由状态下相对所述主体部保持闭合；所述打开单元位于所述夹持部的内部,且与所述夹持部相连，用于驱动所述夹持部相对所述主体部打开。In one embodiment of the present invention, the valve clamping device further includes a driving part, the driving part includes a closing unit and an opening unit; the closing unit is at least partly located inside the clamping part, and The clamping part is connected to keep the clamping part closed relative to the main body in a free state; the opening unit is located inside the clamping part and is connected to the clamping part for The clamping part is driven to open relative to the main part.
在本发明一个实施例中,所述闭合单元为一个扭簧，所述扭簧包括一个簧体以及两个簧臂，两个所述簧臂分别从所述簧体两相对末端延伸出,且每个所述簧臂均与一个所述夹持件相互连接。In one embodiment of the present invention, the closing unit is a torsion spring, the torsion spring includes a spring body and two spring arms, and the two spring arms respectively extend from two opposite ends of the spring body, and Each of the spring arms is interconnected with one of the clips.
在本发明一个实施例中,所述闭合单元为一个“V”形弹片，所述弹片的两端中的每一端均与一个所述夹持件相互连接。In one embodiment of the present invention, the closing unit is a "V"-shaped elastic piece, and each of the two ends of the elastic piece is connected to one of the clamping pieces.
在本发明一个实施例中,所述打开单元包括两个连杆体，每个所述连杆体均包括相对设置的第一连接端以及第二连接端，其中一个所述连杆体的第一连接端与一个所述夹持件转动连接，另一个所述连杆体的第一连接端与另一个所述夹持件转动连接；两个所述第二连接端相互转动连接,所述支撑部呈长条状，两个所述连杆体的两个所述第二连接端设于所述支撑部、且可沿所述支撑部轴向移动。In one embodiment of the present invention, the opening unit includes two connecting rod bodies, each of the connecting rod bodies includes a first connecting end and a second connecting end oppositely arranged, and the first connecting rod body of one of the connecting rod bodies One connecting end is rotatably connected to one of the clamping parts, and the first connecting end of the other connecting rod body is rotatably connected to the other clamping part; the two second connecting ends are rotatably connected to each other. The support part is in the shape of a strip, and the two second connecting ends of the two connecting rod bodies are arranged on the support part and can move axially along the support part.
实施本发明的瓣膜夹持装置，可以通过将瓣膜夹持于主体部和夹持部之间的方式对瓣膜进行修复。由于所述主体部的一端与所述支撑部的第一端相连,所述主体部的另一端围绕所述支撑部,故结构简单。另外,仅仅需要对夹持部进行操作就可以进行瓣膜的修复，故操作方便。By implementing the valve clamping device of the present invention, the valve can be repaired by clamping the valve between the main body part and the clamping part. Since one end of the main body part is connected to the first end of the support part, and the other end of the main body part surrounds the support part, the structure is simple. In addition, the valve can be repaired only by operating the clamping part, so the operation is convenient.
附图说明Description of drawings
下面将结合附图及实施例对本发明作进一步说明，附图中：The present invention will be further described below in conjunction with accompanying drawing and embodiment, in the accompanying drawing:
图1、图2为现有技术的固定装置的整体结构示意图；Fig. 1, Fig. 2 are the overall structural schematic diagrams of the fixing device of prior art;
图3为本发明的瓣膜夹持装置的整体结构示意图，瓣膜夹持装置包括支撑部、主体部、驱动部以及夹持部，夹持部包括两个夹持件，驱动部包括一个打开单元以及一个闭合单元；Figure 3 is a schematic diagram of the overall structure of the valve clamping device of the present invention, the valve clamping device includes a support part, a main body part, a driving part and a clamping part, the clamping part includes two clamping parts, the driving part includes an opening unit and a closed unit;
图4为图1中的瓣膜夹持装置的主体部的内部结构示意图；Fig. 4 is a schematic diagram of the internal structure of the main body of the valve clamping device in Fig. 1;
图5为图1中的瓣膜夹持装置的支撑部的结构示意图；Fig. 5 is a schematic structural view of the support part of the valve clamping device in Fig. 1;
图6为主体部套设于支撑部上的结构示意图，主体部包括一个网管状本体；Figure 6 is a schematic structural view of the main body sleeved on the support part, the main body includes a network tubular body;
图7为图6中的主体部的网管状本体的结构示意图；Fig. 7 is a schematic structural view of the network tubular body of the main body in Fig. 6;
图8为具有加强网管的网管状本体的结构示意图，加强网管包括第一组波形环状物以及第二组波形环状物；Fig. 8 is a structural schematic diagram of a network tubular body with a reinforced network management, and the reinforced network management includes a first set of wave-shaped rings and a second set of wave-shaped rings;
图9为图8中的加强网管的第一组波形环状物以及第二组波形环状物的结构示意图；Fig. 9 is a structural schematic diagram of the first group of corrugated rings and the second group of corrugated rings of the reinforced network management in Fig. 8;
图10为夹持件的结构示意图；Figure 10 is a schematic structural view of the clamping member;
图11为闭合单元的结构示意图；Fig. 11 is a schematic structural diagram of a closed unit;
图12为打开单元的连杆体的结构示意图；Fig. 12 is a structural schematic diagram of the connecting rod body of the opening unit;
图13为瓣膜夹持装置连接部分输送系统的结构示意图；Fig. 13 is a structural schematic diagram of the delivery system of the connecting part of the valve clamping device;
图14、图16、图17为使用输送系统输送瓣膜夹持装置以夹持二尖瓣的各个步骤的示意图；Fig. 14, Fig. 16, Fig. 17 are schematic diagrams of various steps of using the delivery system to deliver the valve clamping device to clamp the mitral valve;
图15为图14中的瓣膜夹持装置处于闭合状态的结构示意图；Fig. 15 is a schematic structural view of the valve clamping device in Fig. 14 in a closed state;
图18、图19为本发明第二实施例的瓣膜夹持装置的结构示意图；Fig. 18 and Fig. 19 are schematic structural views of the valve clamping device according to the second embodiment of the present invention;
图20为第二实施例中闭合单元的结构示意图；Fig. 20 is a schematic structural diagram of the closing unit in the second embodiment;
图21为本发明第三实施例的瓣膜夹持装置的结构示意图；Fig. 21 is a schematic structural view of a valve clamping device according to a third embodiment of the present invention;
图22为第三实施例中闭合单元的结构示意图；Fig. 22 is a schematic structural view of the closed unit in the third embodiment;
图23为本发明第四实施例的瓣膜夹持装置的整体结构示意图；Fig. 23 is a schematic diagram of the overall structure of the valve clamping device according to the fourth embodiment of the present invention;
图24为本发明第四实施例的闭合单元的示意图；Fig. 24 is a schematic diagram of a closed unit of a fourth embodiment of the present invention;
图25为本发明第五实施例的瓣膜夹持装置的整体结构示意图；Fig. 25 is a schematic diagram of the overall structure of the valve clamping device according to the fifth embodiment of the present invention;
图26为本发明第六实施例的瓣膜夹持装置的整体结构示意图；Fig. 26 is a schematic diagram of the overall structure of the valve clamping device according to the sixth embodiment of the present invention;
图27为图25的瓣膜夹持装置与输送系统连接的结构示意图；Fig. 27 is a schematic structural view of the connection between the valve clamping device of Fig. 25 and the delivery system;
图28为用输送系统将第五实施例的瓣膜夹持装置输送至人体内的示意图。Fig. 28 is a schematic diagram of delivering the valve holding device of the fifth embodiment into the human body by using the delivery system.
具体实施方式Detailed ways
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。In order to have a clearer understanding of the technical features, purposes and effects of the present invention, the specific implementation manners of the present invention will now be described in detail with reference to the accompanying drawings.
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件时，该元件可以直接地连接在另一个元件上,也可以通过一个或者多个连接元件间接地连接在另一个元件上。当一个元件被称为是“连接于”另一个元件，它可以是直接地连接到另一个元件上,或者通过一个或者多个连接元件连接到另一元件上。It should be noted that when an element is referred to as being "fixed" or "disposed on" another element, the element may be directly connected to the other element, or may be indirectly connected to the other element through one or more connecting elements. on one component. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or connected to the other element through one or more connecting elements.
本发明所提供的瓣膜夹持装置可用于修复二尖瓣，也可用于修复三尖瓣。下文以修复二尖瓣为例对本发明的瓣膜夹持装置进行说明。应当知晓，以下描述仅用作举例，并不是对本发明的限制。The valve clamping device provided by the present invention can be used for repairing mitral valve, and can also be used for repairing tricuspid valve. Hereinafter, the valve clamping device of the present invention will be described by taking mitral valve repair as an example. It should be understood that the following description is only used as an example rather than limiting the present invention.
图3、图4提供了本发明第一实施例的瓣膜夹持装置100。瓣膜夹持装置100包括支撑部10，主体部20，夹持部30，以及驱动部40。3 and 4 provide a valve clamping device 100 according to a first embodiment of the present invention. The valve clamping device 100 includes a supporting part 10 , a main body part 20 , a clamping part 30 , and a driving part 40 .
所述支撑部10呈管状且具有相对的第一端11以及第二端12。所述主体部20周向环设于所述支撑部10外侧。所述主体部20的一端与所述支撑部10第一端11固定连接，所述主体部20的围绕支撑部10。所述夹持部30围设于所述主体部20的外侧，其一端与支撑部10的第一端11转动连接，另一端可相对所述主体部20以所述第一端11为中心呈辐射状展开或闭合。所述夹持部30朝向主体部20的一侧上还设有锚定件33；主体部20上设有定位孔或者定位槽23。夹持部30闭合时，锚定件33穿过瓣膜嵌置于与之相应的定位孔或者定位槽23中，使瓣膜被夹持于夹持部30和主体部20之间。所述驱动部40包括一个闭合单元41和一个打开单元42；所述闭合单元41部分位于所述夹持部30内部且与所述夹持部30相连,用于使所述夹持部30在自由状态下相对所述主体部20保持闭合；所述打开单元42位于所述夹持部内部,且与所述夹持部30相连，用于将所述夹持部30从闭合状态相对所述主体部20打开。The supporting portion 10 is tubular and has a first end 11 and a second end 12 opposite to each other. The main body portion 20 is circumferentially disposed outside the support portion 10 . One end of the main body part 20 is fixedly connected to the first end 11 of the support part 10 , and the main part 20 surrounds the support part 10 . The clamping part 30 is arranged on the outside of the main body 20, one end of which is rotatably connected to the first end 11 of the support part 10, and the other end can be formed relative to the main body 20 with the first end 11 as the center. Expand or close radially. The clamping portion 30 is further provided with an anchor 33 on a side facing the main body 20 ; the main body 20 is provided with a positioning hole or a positioning groove 23 . When the clamping part 30 is closed, the anchor 33 passes through the valve and is embedded in the corresponding positioning hole or positioning groove 23 , so that the valve is clamped between the clamping part 30 and the main body 20 . The driving part 40 includes a closing unit 41 and an opening unit 42; the closing unit 41 is partly located inside the clamping part 30 and connected with the clamping part 30, for making the clamping part 30 Keep closed relative to the main body part 20 in a free state; the opening unit 42 is located inside the clamping part and is connected with the clamping part 30, and is used for closing the clamping part 30 from the closed state to the The main body part 20 is opened.
请参阅图5，支撑部10还包括一个连接头13、一个条形引导件14以及一个第一连接孔15；所述连接头13设置于第二端12，用于与输送系统500的内鞘管50(参见图13)可拆卸连接；所述条形引导件为14径向贯穿所述支撑部且沿所述支撑部轴向延伸的条形通孔，用于引导所述打开单元42相对所述支撑部10移动；所述第一连接孔15靠近所述第一端11,其径向贯穿所述支撑部10的第一端11，用于收容第一枢轴32。Please refer to FIG. 5 , the support part 10 also includes a connection head 13, a strip guide 14 and a first connection hole 15; The pipe 50 (see FIG. 13 ) is detachably connected; the strip-shaped guide is a strip-shaped through-hole that 14 radially penetrates the support portion and extends axially along the support portion, for guiding the opening unit 42 to The support portion 10 moves; the first connection hole 15 is close to the first end 11 , and radially penetrates the first end 11 of the support portion 10 for receiving the first pivot 32 .
需要说明的是，连接头13优选为设置于第二端12周面的外螺纹，当然连接头13也可为卡扣或卡勾等其他结构，只要可以实现与输送系统500配对连接即可。条形引导件14也可以为设于所述支撑部10外表面的，且沿所述支撑部10的轴向延伸的凹槽。It should be noted that the connecting head 13 is preferably an external thread provided on the peripheral surface of the second end 12 , of course, the connecting head 13 can also be a buckle or a hook and other structures, as long as it can be matched with the delivery system 500 . The strip guide 14 can also be a groove provided on the outer surface of the support part 10 and extending along the axial direction of the support part 10 .
还需要说明的是，支撑部10优选采用外径1.4mm-1.6mm，内径1.0mm-1.2mm的316L不锈钢管或者镍钛金属管制成。It should also be noted that the support part 10 is preferably made of 316L stainless steel tube or nickel-titanium metal tube with an outer diameter of 1.4mm-1.6mm and an inner diameter of 1.0mm-1.2mm.
请一并参阅图6、图7，主体部20为弹性件且呈网状结构,其包括一个网管状本体21，以及两个固定件24；网管状本体21套设于支撑部10上，其每一端均通过一个固定件24连设于支撑部10表面。Please refer to Fig. 6 and Fig. 7 together, the main body 20 is an elastic part and has a net structure, which includes a net tube body 21 and two fixing parts 24; the net tube body 21 is sleeved on the support part 10, and its Each end is connected to the surface of the supporting part 10 through a fixing piece 24 .
固定件24优选选用螺纹钢套。在形成主体部20时，首先将两端开放的网管状本体21套设于支撑部10外侧，之后将固定件24套设于支撑部10表面，并使网管状本体21的每一端分别夹持于一个固定件24内表面和支撑部10外表面之间，进一步通过激光焊接固定件24实现网管状本体21的两端与支撑部10的固定连接。网管状本体21套设于支撑部10上的长度以在夹持部30闭合状态时不低于夹持部30自由端端面的高度为限。The fixing member 24 is preferably a threaded steel sleeve. When forming the main body part 20, firstly, the net tubular body 21 with both ends open is sleeved on the outside of the support part 10, and then the fixing part 24 is sleeved on the surface of the support part 10, and each end of the net tubular body 21 is respectively clamped. Between the inner surface of a fixing part 24 and the outer surface of the supporting part 10 , the fixing part 24 is further laser-welded to realize the fixed connection between the two ends of the net tubular body 21 and the supporting part 10 . The length of the mesh-shaped body 21 sleeved on the supporting part 10 is limited to not lower than the height of the free end surface of the clamping part 30 when the clamping part 30 is closed.
可以理解的是,网管状本体21与支撑部10连接的方式不限于通过螺纹钢套连接，还可以直接通过焊接方式将网管状本体21的两端分别与支撑部10的两端相连。优选地,为制造方便,连接头13可以为设置于一个固定件24外表面的螺纹结构。It can be understood that, the connection method between the tubular body 21 and the support part 10 is not limited to the connection through the threaded steel sleeve, and the two ends of the tubular body 21 and the two ends of the support part 10 can also be directly connected by welding. Preferably, for the convenience of manufacture, the connecting head 13 can be a threaded structure provided on the outer surface of a fixing part 24 .
如图7所示，网管状本体21两端开放。该网管状本体21包括多条相互交错、且沿中心轴螺旋绕制的编织丝22。多个编织丝22之间相互交叉形成多个网格，此时,该多个网格形成与夹持部30的锚定件33配对设置的定位孔或定位槽23。网管状本体21优选为由具有超弹性形状记忆功能的材料编织而成的网状结构，例如镍钛合金。As shown in FIG. 7 , both ends of the tubular body 21 are open. The net tubular body 21 includes a plurality of interlaced braided wires 22 that are helically wound along a central axis. A plurality of braided filaments 22 cross each other to form a plurality of grids. At this time, the plurality of grids form positioning holes or positioning grooves 23 that are paired with the anchors 33 of the clamping portion 30 . The net tubular body 21 is preferably a mesh structure woven from a material with superelastic shape memory function, such as nickel-titanium alloy.
网管状本体21连设于支撑部10上后，网管状本体21的网状表面形成与自然瓣膜接触的面，网管状本体21的中间部分相对支撑部10表面自然膨开，与支撑部10表面形成一运动空间，使网管状本体21可径向受力回缩,同时也提供一反向作用力。After the net tubular body 21 is connected to the support part 10, the mesh surface of the net tubular body 21 forms a surface in contact with the natural valve. A movement space is formed, so that the net tubular body 21 can be retracted under radial force, and a reverse force is also provided at the same time.
请一并参阅图8、图9，为了进一步提高网管状本体21的径向支撑力，优选地,网管状本体21上设有加强网管25。加强网管25为波形环状物。该波形环状物包括第一组波形环状物251和第二组波形环状物252。相邻组波形环状物之间相互交错绕制，配合形成网状物，每组波形环状物均是由金属丝环绕形成的。加强网管25的金属丝沿网管状本体21的圆周依次穿过网管状本体21的网孔，使加强网管25和网管状本体21编织在一起。当然也可以使用缝线将加强网管25直接缝合于网管状本体21上。需要说明的是，该加强网管25与部分或者全部网管状本体21套设或者交叉穿织。Please refer to FIG. 8 and FIG. 9 together. In order to further improve the radial support force of the tubular body 21 , preferably, the tubular body 21 is provided with a reinforced mesh tube 25 . The reinforced network pipe 25 is a corrugated ring. The wave-shaped rings include a first set of wave-shaped rings 251 and a second set of wave-shaped rings 252 . Adjacent groups of wave-shaped rings are interlaced and wound together to form a mesh, and each group of wave-shaped rings is formed by surrounding metal wires. The metal wires of the reinforcing net pipe 25 pass through the meshes of the net tubular body 21 sequentially along the circumference of the net tubular body 21, so that the reinforcing net pipe 25 and the net tubular body 21 are braided together. Of course, sutures can also be used to directly sew the reinforcing net tube 25 on the net tubular body 21 . It should be noted that, the reinforced net pipe 25 is sheathed or cross-woven with part or all of the net tubular body 21 .
为了更进一步提高网管状本体21的径向支撑力，网管状本体21也可以为双层结构，该加强网管25至少部分与内层和/或外层网管状本体21套设或者交叉穿织。In order to further improve the radial support force of the tubular body 21 , the tubular body 21 can also be a double-layer structure, and the reinforcing net tube 25 is at least partially sheathed or cross-woven with the inner and/or outer tubular body 21 .
还可以理解的是，主体部20还可以由其它软性材质制成，例如主体部20可以为采用硅胶制成的硅胶体或者是采用海绵制成的海绵体(未图示)。硅胶体或者海绵体的两端通过粘接或者热熔等的方式与支撑部10的表面相连。该硅胶体和海绵体可以为实心或者是空心结构。实心的硅胶体或海绵体上设有用于与锚定件33配对的定位槽；空心的硅胶体或海绵体上设有用于与锚定件33配对的定位孔。It can also be understood that the main body 20 can also be made of other soft materials, for example, the main body 20 can be a silicone body made of silica gel or a sponge body made of sponge (not shown). The two ends of the silica gel or the sponge are connected to the surface of the support part 10 by means of bonding or hot melting. The silica colloid and sponge body can be solid or hollow. The solid silicone body or sponge body is provided with a positioning groove for matching with the anchoring piece 33 ; the hollow silicone body or sponge body is provided with a positioning hole for matching with the anchoring piece 33 .
还可以理解的是,主体部20也可以为非弹性件,该非弹性件的材质例如为不锈钢或者铁等。该非弹性的主体部20可以为实/空心结构或者呈网状设置。当非弹性的主体部20呈网状设置时，其可以是通过激光切割形成，两端优选采用焊接的方式与支撑部10表面相连；当非弹性的主体部20呈实心或者是空心结构时，支撑部10穿过主体部20，主体部20的两端仍优选采用焊接的方式与支撑部10表面相连。It can also be understood that the main body portion 20 may also be a non-elastic member, and the material of the non-elastic member is, for example, stainless steel or iron. The non-elastic body part 20 can be a solid/hollow structure or a net shape. When the non-elastic body part 20 is arranged in a net shape, it can be formed by laser cutting, and the two ends are preferably connected to the surface of the support part 10 by welding; when the non-elastic body part 20 is in a solid or hollow structure, The support part 10 passes through the main body part 20 , and the two ends of the main part 20 are preferably connected to the surface of the support part 10 by welding.
同时，需要说明的是，本实施例中,网管状本体21套设于支撑部10上的位置使条形引导件14容设于网管状本体21内侧,而支撑部10是通过打开单元42与夹持件31相连的，故,主体部20上设有用于使打开单元42伸出并且运动的开口26。可以理解的是，当网管状本体21套设于支撑部10上的位置使条形引导件14位于网管状本体21外侧时,由于主体部20不会阻碍打开单元42的运动,故此种情况下,开口26可以省略不要。At the same time, it should be noted that, in this embodiment, the position of the network tubular body 21 sleeved on the support part 10 is such that the strip guide 14 is accommodated inside the network tubular body 21, and the support part 10 is formed by opening the unit 42 and The clamping pieces 31 are connected, so the main body 20 is provided with an opening 26 for extending and moving the opening unit 42 . It can be understood that when the tubular body 21 is sleeved on the support portion 10 so that the strip guide 14 is located outside the tubular body 21, since the main body 20 will not hinder the movement of the opening unit 42, in this case , The opening 26 can be omitted.
请再次参见图2，夹持部30以可以配对的将瓣膜夹持于主体部20和夹持部30之间为限。夹持部30包括两个可相对开合的、且与支撑部10可转动连接的夹持件31。两个夹持件31通过第一枢轴32连接于支撑部10的第一连接孔15位置。可以理解的是这里的第一枢轴32可以包括一根轴体，也可以包括设置于同一轴线的多个轴体。Please refer to FIG. 2 again, the clamping part 30 is limited to clamp the valve between the main body part 20 and the clamping part 30 in a paired manner. The clamping part 30 includes two clamping parts 31 that can be opened and closed relative to each other and are rotatably connected with the supporting part 10 . The two clips 31 are connected to the position of the first connecting hole 15 of the supporting part 10 through the first pivot 32 . It can be understood that the first pivot 32 here may include one shaft, or may include multiple shafts arranged on the same axis.
请一并参见图10，每个夹持件31均呈U形结构,其包括两个相对设置的侧板311，以及一个位于两个侧板311之间的中间板312。两个侧板311分别连接于中间板312相对的两个侧缘，且两个侧板311相对中间板312同向弯折形成U形结构。每个侧板311远离中间板312的一侧边缘设有至少一个锚定件314。本实施例中,该至少一个锚定件314的个数为多个，且该多个锚定件314形成锯齿状结构。可以理解的是，该U形结构的开口朝向主体部20。还可以理解的是，该多个锚定件314还可以形成方形波结构或者正弦波结构。同样还可以理解，所述至少一个锚定件314的个数也可以为一个，此时，该锚定件314的截面可以呈梯形、三角形、半圆形等形状。Please also refer to FIG. 10 , each clamping member 31 has a U-shaped structure, which includes two opposite side panels 311 and a middle panel 312 located between the two side panels 311 . The two side panels 311 are respectively connected to two opposite side edges of the middle panel 312 , and the two side panels 311 are bent in the same direction relative to the middle panel 312 to form a U-shaped structure. At least one anchoring piece 314 is provided on an edge of each side plate 311 away from the middle plate 312 . In this embodiment, the number of the at least one anchoring piece 314 is multiple, and the multiple anchoring pieces 314 form a zigzag structure. It can be understood that the opening of the U-shaped structure faces the main body 20 . It can also be understood that the plurality of anchors 314 can also form a square wave structure or a sine wave structure. It can also be understood that the number of the at least one anchoring piece 314 can also be one, and in this case, the cross-section of the anchoring piece 314 can be in the shape of trapezoid, triangle, semicircle or the like.
中间板312的长度小于侧板311的长度，以使每个侧板311一端均相对中间板312伸出，形成一个连接段313。两个连接段313之间形成中空区域。如上所述，第一枢轴32穿过连接段313及第一连接孔15将所述支撑部10与所述夹持件31转动连接。The length of the middle board 312 is shorter than that of the side boards 311 , so that one end of each side board 311 protrudes relative to the middle board 312 to form a connecting section 313 . A hollow area is formed between the two connection sections 313 . As mentioned above, the first pivot 32 passes through the connecting section 313 and the first connecting hole 15 to rotatably connect the supporting part 10 to the clamping member 31 .
每个夹持件31还包括两个分别穿设于两个侧板311上的第二连接孔315。该两个第二连接孔315相对设置。Each clamping member 31 also includes two second connecting holes 315 respectively penetrating through the two side plates 311 . The two second connection holes 315 are opposite to each other.
每个夹持件31还包括用于与闭合单元41相连的连接杆316，所述连接杆316设置于两个侧板311之间，且连接杆316的相对两端分别与两个侧板311相连。优选连接杆316依次穿过两个侧板311实现与两个侧板311的连接。此时需要说明的时，当可以用其他方式实现两个侧板311之间间距的固定时，中间板312也可以省略。例如，当设有连接杆316且连接杆316的相对两端分别与两个侧板311相互固定时，中间板312即可省略。Each clip 31 also includes a connecting rod 316 for connecting with the closing unit 41, the connecting rod 316 is arranged between the two side plates 311, and the opposite ends of the connecting rod 316 are connected to the two side plates 311 respectively. connected. Preferably, the connecting rod 316 passes through the two side plates 311 in turn to realize the connection with the two side plates 311 . When it needs to be explained at this time, when the distance between the two side plates 311 can be fixed in other ways, the middle plate 312 can also be omitted. For example, when the connecting rod 316 is provided and the opposite ends of the connecting rod 316 are fixed to the two side plates 311 respectively, the middle plate 312 can be omitted.
夹持件31的侧板311以及中间板312优选选择采用0.3mm-0.5mm的316L不锈钢制成。The side plate 311 and the middle plate 312 of the clamping member 31 are preferably made of 316L stainless steel with a thickness of 0.3mm-0.5mm.
如图11所示，第一实施例的闭合单元41优选为由316L不锈钢丝绕制而成的扭簧。该闭合单元41包括簧体411、以及两个第一簧臂412；簧体411为由钢丝螺旋环绕形成的中空环状结构；两个第一簧臂412分别从簧体411两相对末端延伸出，且每个第一簧臂412均包括一个由簧体411末端切向延伸出的直臂段413以及一个由该第一直臂段413远离簧体411的一端螺旋绕制形成的第一圈体414。安装时，每个第一圈体414均套设于一个夹持件31的连接杆316上，每个直臂段413均穿过一个夹持件31的两个连接段313之间形成中空区域，且闭合单元41的簧体411位于夹持部30的外侧(如图4所示)，从而实现闭合单元41与夹持部30的连接。As shown in FIG. 11 , the closing unit 41 of the first embodiment is preferably a torsion spring wound by 316L stainless steel wire. The closing unit 41 includes a spring body 411 and two first spring arms 412; the spring body 411 is a hollow ring structure formed by a steel wire spiral; the two first spring arms 412 extend from two opposite ends of the spring body 411 respectively , and each first spring arm 412 includes a straight arm segment 413 extending tangentially from the end of the spring body 411 and a first coil formed by helically winding the end of the first straight arm segment 413 away from the spring body 411 Body 414. During installation, each first ring body 414 is sleeved on the connecting rod 316 of a clamping member 31, and each straight arm section 413 passes through a hollow area between the two connecting segments 313 of a clamping member 31 , and the spring body 411 of the closing unit 41 is located outside the clamping portion 30 (as shown in FIG. 4 ), so as to realize the connection between the closing unit 41 and the clamping portion 30 .
两个第一簧臂412之间的夹角以能够在自由状态使两个夹持件31相对主体部20夹紧为限。第一簧臂412之间的夹角在扭簧处于自然状态下为0°-30°，优选选取10°。由于第一簧臂412之间的夹角较小，则两个夹持件31在自由状态下可相对主体部20闭合。The included angle between the two first spring arms 412 is limited to allow the two clamping members 31 to clamp relative to the main body 20 in a free state. The included angle between the first spring arms 412 is 0°-30° when the torsion spring is in a natural state, preferably 10°. Since the included angle between the first spring arms 412 is small, the two clamping parts 31 can be closed relative to the main body 20 in a free state.
可以理解的，簧体411由于没有约束，可以容设于两个夹持件31内侧，也可以从夹持件31的两个连接段313之间的空间伸出到夹持件31的外侧。本实施例中，簧体411由钢丝连续螺旋绕制形成，未预留使支撑部10第一端11通过的空间，从而簧体411伸出到夹持件31的外侧。It can be understood that the spring body 411 can be accommodated inside the two clamping pieces 31 due to no constraints, and can also protrude from the space between the two connecting sections 313 of the clamping piece 31 to the outside of the clamping piece 31 . In this embodiment, the spring body 411 is formed by continuous helical winding of steel wire, and no space is reserved for the first end 11 of the supporting part 10 to pass through, so the spring body 411 protrudes to the outside of the clamping member 31 .
请一并参见图1、图2以及图12，所述打开单元42包括两个连杆体420。每个所述连杆体420均包括相对设置的第一连接端426以及第二连接端427，其中,一个连杆体420的第一连接端426与一个夹持件31转动连接，另一个连杆体420的第一连接端426与另一个夹持件420转动连接；两个第二连接端427相互转动相连，且可相对支撑部10轴向移动。Please refer to FIG. 1 , FIG. 2 and FIG. 12 , the opening unit 42 includes two connecting rod bodies 420 . Each of the connecting rod bodies 420 includes a first connecting end 426 and a second connecting end 427 oppositely arranged, wherein, the first connecting end 426 of one connecting rod body 420 is rotatably connected to one clamping member 31, and the other is connected to The first connecting end 426 of the rod body 420 is rotatably connected to the other clamping member 420 ; the two second connecting ends 427 are rotatably connected to each other and can move axially relative to the supporting part 10 .
本实施例中，每个连杆体420的第一连接端426通过第二枢轴423与夹持件31的第二连接孔315处转动相连，也就是说，第二枢轴423穿过第一连接端426及第二连接孔315将所述打开单元42与夹持部30相连；每个连杆420的第二连接端427通过第三枢轴425与支撑部10的条形引导件14处相连，也就是说，第三枢轴425穿过两个第二连接端427及条形引导件14将所述打开单元42与支撑部10相连，从而实现所述打开单元42与夹持部30相连,且所述打开单元42可相对支撑部10的轴向移动。In this embodiment, the first connecting end 426 of each connecting rod body 420 is rotationally connected with the second connecting hole 315 of the clamping member 31 through the second pivot 423, that is, the second pivot 423 passes through the first A connection end 426 and the second connection hole 315 connect the opening unit 42 with the clamping portion 30; the second connection end 427 of each link 420 is connected to the strip guide 14 of the support portion 10 through the third pivot 425 That is to say, the third pivot 425 passes through the two second connecting ends 427 and the strip guide 14 to connect the opening unit 42 with the support part 10, thereby realizing the connection between the opening unit 42 and the clamping part. 30, and the opening unit 42 can move relative to the axial direction of the support part 10.
具体的，每个连杆体420均包括两个第一杆体421以及一个第二杆体422。所述两个第一杆体421相互平行设置；所述第二杆体422设置于两个第一杆体421之间，用于保持两个杆体之间间距。Specifically, each connecting rod body 420 includes two first rod bodies 421 and one second rod body 422 . The two first rods 421 are arranged parallel to each other; the second rod 422 is arranged between the two first rods 421 for maintaining the distance between the two rods.
在安装状态，两个第一杆体421套设于第二枢轴423设置于第一侧板311以及第二侧板311之间的部分；第三枢轴425穿过第一杆体421与条形引导件14且使支撑部10设置于两个杆体之间，第三枢轴425的直径小于条形轨道的宽度，使第三枢轴425能够沿着条形引导件14轴向移动。In the installed state, the two first rods 421 are sleeved on the part where the second pivot 423 is arranged between the first side plate 311 and the second side plate 311; the third pivot 425 passes through the first rod 421 and the bar-shaped The guide 14 and the support portion 10 are disposed between the two rods, the diameter of the third pivot 425 is smaller than the width of the strip track, so that the third pivot 425 can move axially along the strip guide 14 .
可以理解的是：也可以不设置第二杆体422，只要可以保持两个第一杆体421之间的相对距离即可。需要说明的是,当条形引导件14为径向穿通于支撑部10的相对侧面的通孔时，第三枢轴425为一根轴体，穿过条形引导件14且两端从支撑部10表面伸出。可以理解的是,当条形引导件14的个数为两个,且该两个条形引导件14为分别设于所述支撑部10外表面相对两侧且沿所述支撑部10的轴向延伸的两个凹槽时,采用共轴的两根枢轴来替代第三枢轴425也可实现本发明的目的,此时,每根枢轴的一端均收容于一个凹槽中,且均可沿所述支撑部10的轴向移动。It can be understood that the second rod body 422 may not be provided, as long as the relative distance between the two first rod bodies 421 can be maintained. It should be noted that, when the strip-shaped guide 14 is a through hole passing radially through the opposite side of the support part 10, the third pivot 425 is a shaft that passes through the strip-shaped guide 14 and the two ends are connected from the support Part 10 protrudes from the surface. It can be understood that when the number of strip guides 14 is two, and the two strip guides 14 are respectively arranged on opposite sides of the outer surface of the support portion 10 and along the axis of the support portion 10 When there are two grooves extending in the same direction, the purpose of the present invention can also be achieved by using two coaxial pivots instead of the third pivot 425. At this time, one end of each pivot is accommodated in one groove, and All can move along the axial direction of the support part 10 .
连杆体420优选选择使用0.3mm-0.5mm的316L不锈钢制成。The connecting rod body 420 is preferably made of 0.3mm-0.5mm 316L stainless steel.
参见图13所示，为了实现对第三枢轴425的推拉。第三枢轴425上还设有推拉杆424，该推拉杆424收容于管状支撑部10内部，用于与输送系统500的推拉机构52相连。推拉杆424一端使使第三枢轴425径向穿过，实现与第三枢轴425的固定连接；推拉杆424的另一端朝向支撑部10第二端12所在的方向轴向延伸，用于通过螺纹连接的方式与输送系统500相连。推拉杆424的外径小于管状支撑部10的内径，推拉杆424可相对支撑部10轴向运动。Referring to FIG. 13 , in order to realize the push and pull of the third pivot 425 . A push-pull rod 424 is also provided on the third pivot 425 , and the push-pull rod 424 is housed inside the tubular support portion 10 and used for connecting with the push-pull mechanism 52 of the delivery system 500 . One end of the push-pull rod 424 allows the third pivot shaft 425 to pass through radially to achieve a fixed connection with the third pivot shaft 425; It is connected with the delivery system 500 by means of threaded connection. The outer diameter of the push-pull rod 424 is smaller than the inner diameter of the tubular support part 10 , and the push-pull rod 424 can move axially relative to the support part 10 .
需要说明的是，为了使器械具有良好生物相容性，通过离子气相沉积的方式在所有金属零件的表面镀一层生物相容性材料，例如是氮化钛涂层，此技术已为公知技术，此处便不再赘述。It should be noted that, in order to make the device have good biocompatibility, a layer of biocompatible material, such as titanium nitride coating, is coated on the surface of all metal parts by means of ion vapor deposition, which is a well-known technology , which will not be repeated here.
参见图13至图17所示，在对二尖瓣进行修复时，首先经由股静脉进入至心脏内部、进一步通过穿刺房间隔进入左心房，随后穿过二尖瓣的两个瓣叶之间的空隙进入左心室并且使瓣膜夹持装置100靠近二尖瓣所在的位置，此时瓣膜夹持装置100容置于输送系统500的外鞘管50内部，输送系统500的收容于外鞘管50中的内鞘管51与瓣膜夹持装置100的连接头13相连，输送系统500的推拉机构52收容于内鞘管51内，且与瓣膜夹持装置100的推拉杆424相连；回撤外鞘管50使瓣膜夹持装置100从外鞘管50中伸出，进一步，在三维超声的引导下，通过输送系统500的推拉机构52推动第三枢轴425使两个夹持件31相对打开；之后，向左心房回撤瓣膜夹持装置100使一个夹持件31的锚定件33所在的一侧表面与一个瓣叶的下表面接触，且使二尖瓣位于主体部20和夹持部30之间；接着，解除推拉机构52对第三枢轴425的推动作用，两个夹持件31在闭合单元41的作用下相对闭合，锚定件33穿过瓣膜组织，且锚定件33穿过瓣膜组织的部分插入到主体部20中。由于主体部20为弹性件，主体部20在夹持件31的作用下受力发生弹性形变的同时也对夹持件31提供一个径向支撑力，使瓣膜被紧紧夹持于夹持件31和主体部20之间，二尖瓣的两个瓣叶之间的空隙由此由一个较大的空隙分隔成较小的两个空隙，从而减少了二尖瓣反流的可能；最后分别解除推拉机构52以及内鞘管51与瓣膜夹持装置100的连接，并将输送系统500撤出体外，使瓣膜夹持装置100单独夹持于瓣膜上对瓣膜进行修复。Referring to Figures 13 to 17, when repairing the mitral valve, it first enters into the heart through the femoral vein, further enters the left atrium through the interatrial septum, and then passes through the space between the two leaflets of the mitral valve. The space enters the left ventricle and makes the valve clamping device 100 close to the position of the mitral valve. At this time, the valve clamping device 100 is accommodated inside the outer sheath tube 50 of the delivery system 500, and the delivery system 500 is accommodated in the outer sheath tube 50 The inner sheath 51 of the valve clamping device 100 is connected to the connecting head 13, the push-pull mechanism 52 of the delivery system 500 is accommodated in the inner sheath 51, and is connected with the push-pull rod 424 of the valve clamping device 100; the outer sheath is withdrawn 50 make the valve clamping device 100 protrude from the outer sheath tube 50, and further, under the guidance of three-dimensional ultrasound, push the third pivot 425 through the push-pull mechanism 52 of the delivery system 500 so that the two clamping parts 31 are relatively opened; after that , the valve clamping device 100 is withdrawn to the left atrium so that the side surface where the anchoring part 33 of a clamping part 31 is located is in contact with the lower surface of a valve leaflet, and the mitral valve is positioned between the main body part 20 and the clamping part 30 between; then, the pushing action of the push-pull mechanism 52 on the third pivot 425 is released, the two clamping parts 31 are relatively closed under the action of the closing unit 41, the anchoring part 33 passes through the valve tissue, and the anchoring part 33 passes through A portion through the valve tissue is inserted into the body portion 20 . Since the main body 20 is an elastic member, the main body 20 is elastically deformed under the force of the clamping part 31, and at the same time provides a radial support force for the clamping part 31, so that the valve is tightly clamped on the clamping part. 31 and the main body 20, the space between the two leaflets of the mitral valve is thus divided into two smaller spaces by a larger space, thereby reducing the possibility of mitral valve regurgitation; Release the connection between the push-pull mechanism 52 and the inner sheath tube 51 and the valve clamping device 100, withdraw the delivery system 500 from the body, and make the valve clamping device 100 clamp on the valve alone to repair the valve.
实施例二：Embodiment two:
图18及图19所示为本发明第二实施例的瓣膜夹持装置100a。瓣膜夹持装置100a与第一实施例中的瓣膜夹持装置100大体上相同，其包括一个支撑部10a，一个主体部20a，一个夹持部30a，以及一个驱动部40a。夹持部30a包括两个相对设置于主体部20a两侧的夹持件31a，夹持件31a上设有连接杆316a。驱动部40a包括一个闭合单元41a和打开单元42a。18 and 19 show a valve clamping device 100a according to a second embodiment of the present invention. The valve clamping device 100a is substantially the same as the valve clamping device 100 in the first embodiment, which includes a support part 10a, a main body part 20a, a clamping part 30a, and a driving part 40a. The clamping portion 30a includes two clamping pieces 31a oppositely disposed on two sides of the main body portion 20a, and the clamping pieces 31a are provided with connecting rods 316a. The driving part 40a includes a closing unit 41a and an opening unit 42a.
不同之处在于，本实施例中的闭合单元41a(如图20所示)采用“V”形弹片，该弹片是由超弹性形状记忆功能的合金制成，例如镍钛合金。该弹片包括两个同向延伸出的第二簧臂412a。每个第二簧臂412a均包括第二直臂段413a，以及从第二直臂段413a一端螺旋绕制形成的第二圈体414a。两个第二直臂段413a远离第二圈体414a的一端相互连接形成V形结构，优选两个第二直臂段413a一体成型。The difference is that the closing unit 41a in this embodiment (as shown in FIG. 20 ) adopts a "V"-shaped shrapnel, which is made of an alloy with a superelastic shape memory function, such as nickel-titanium alloy. The elastic piece includes two second spring arms 412a extending in the same direction. Each second spring arm 412a includes a second straight arm segment 413a, and a second ring body 414a formed by helically winding from one end of the second straight arm segment 413a. The ends of the two second straight arm sections 413a away from the second ring body 414a are connected to each other to form a V-shaped structure, preferably the two second straight arm sections 413a are integrally formed.
第二圈体414a套设于连接杆316a上，弹片的V形结构靠近两个夹持件31a的连接位置。两个第二簧臂412a之间的夹角以能够在自由状态使两个夹持件31a相对主体部20a夹紧为限，例如第二簧臂412a之间的夹角范围为0°-30°，优选选择10°。The second ring body 414a is sheathed on the connecting rod 316a, and the V-shaped structure of the elastic piece is close to the connecting position of the two clamping parts 31a. The angle between the two second spring arms 412a is limited to allow the two clamping parts 31a to be clamped relative to the main body 20a in a free state, for example, the angle range between the second spring arms 412a is 0°-30° °, preferably select 10 °.
实施例三：Embodiment three:
参见图21，本发明第三实施例的瓣膜夹持装置100b与第一实施例中的瓣膜夹持装置100a大体上相同，其包括一个支撑部10b，一个主体部20b，一个夹持部30b，以及一个驱动部40b。支撑部10b包括两个相对的第一端11b以及第二端12b。夹持部30b包括两个相对设置于主体部20b两侧的夹持件31b。驱动部40b包括一个闭合单元41b和打开单元42b。Referring to FIG. 21 , the valve clamping device 100b of the third embodiment of the present invention is substantially the same as the valve clamping device 100a of the first embodiment, which includes a support portion 10b, a main body portion 20b, and a clamping portion 30b, and a driving part 40b. The support portion 10b includes two opposite first ends 11b and second ends 12b. The clamping portion 30b includes two clamping pieces 31b oppositely disposed on two sides of the main body portion 20b. The driving part 40b includes a closing unit 41b and an opening unit 42b.
参见图22，闭合单元41b为扭簧，其包括簧体411b、分别从簧体411b两相对末端延伸出的第一簧臂412b；簧体411b呈由钢丝螺旋环绕形成的环状结构，每个第一簧臂412b包括由簧体411b末端切向延伸出的第一直臂段413b以及由该第一直臂段413b远离簧体411的一端螺旋绕制形成的第一圈体414b。Referring to Fig. 22, the closing unit 41b is a torsion spring, which includes a spring body 411b and first spring arms 412b extending from two opposite ends of the spring body 411b; The first spring arm 412b includes a first straight arm section 413b extending tangentially from the end of the spring body 411b and a first ring body 414b formed by helically winding the end of the first straight arm section 413b away from the spring body 411 .
不同之处在于，第一实施例中的簧体411b仅仅包括由钢丝连续螺旋绕制形成的一个环形件，而本实施例中簧体411b包括两个间隔设置的，分别由钢丝连续螺旋绕制形成的第一环形件4111以及第二环形件4112，且第一环形件4111和第二环形件4112之间通过钢丝相连。两个环形件之间的间隔尺寸满足：可使支撑部10b第一端11b从第一环形件4111和第二环形件4112之间中通过。The difference is that the spring body 411b in the first embodiment only includes one annular member formed by continuous helical winding of steel wires, while the spring body 411b in this embodiment includes two rings arranged at intervals, each of which is continuously helically wound by steel wires. A first ring 4111 and a second ring 4112 are formed, and the first ring 4111 and the second ring 4112 are connected by a steel wire. The distance between the two rings satisfies that the first end 11 b of the support part 10 b can pass between the first ring 4111 and the second ring 4112 .
由于簧体411b具有可使支撑部10b通过的空间，则簧体411b收容于两个夹持件31b内侧，此时第一簧臂412b的长度较短，缩小了扭簧的规格。Since the spring body 411b has a space through which the supporting portion 10b can pass, the spring body 411b is accommodated inside the two clamping parts 31b. At this time, the length of the first spring arm 412b is relatively short, which reduces the size of the torsion spring.
实施例四Embodiment four
参见图23，本发明第四实施例的瓣膜夹持装置100c与第二实施例中的瓣膜夹持装置100b大体上相同，其包括一个支撑部10c，一个主体部20c，一个夹持部30c，以及一个驱动部40c。支撑部10c包括两个相对的第一端11c以及第二端12c，夹持部30c包括两个相对设置于主体部20c两侧的夹持件31c。驱动部40c包括一个闭合单元41c和打开单元42c。Referring to FIG. 23 , the valve clamping device 100c of the fourth embodiment of the present invention is substantially the same as the valve clamping device 100b of the second embodiment, which includes a support portion 10c, a main body portion 20c, and a clamping portion 30c, and a drive portion 40c. The supporting portion 10c includes two opposite first ends 11c and second ends 12c, and the clamping portion 30c includes two clamping pieces 31c disposed on opposite sides of the main body 20c. The driving part 40c includes a closing unit 41c and an opening unit 42c.
闭合单元41c采用“V”形弹片，该弹片是由超弹性形状记忆功能的合金制成，例如镍钛合金。该弹片包括两个同向延伸出的第二簧臂412c。每个第二簧臂412c包括第二直臂段413c，以及从第二直臂段413c一端螺旋绕制形成的第二圈体414c。两个第二直臂段413c远离第二圈体414c的一端相互连接形成V形结构，优选两个第二直臂段413c一体成型。The closing unit 41c adopts a "V"-shaped shrapnel, which is made of an alloy with a superelastic shape memory function, such as nickel-titanium alloy. The elastic piece includes two second spring arms 412c extending in the same direction. Each second spring arm 412c includes a second straight arm segment 413c, and a second ring body 414c formed by helically winding from one end of the second straight arm segment 413c. The ends of the two second straight arm sections 413c away from the second ring body 414c are connected to each other to form a V-shaped structure, preferably the two second straight arm sections 413c are integrally formed.
不同之处在于，本实施例中弹片V型结构中部设有用于使支撑部10c第一端11c穿过的通孔411c。通孔411c的大小以可使支撑部10c第一端11c从通孔411c中通过为限。由于V形结构上具有可使支撑部10c通过的空间，整个弹片均收容于两个夹持件31c内侧，第一簧臂412c的长度较短，缩小了弹片整体的规格。The difference is that in this embodiment, a through hole 411c is provided in the middle of the V-shaped structure of the elastic piece for passing the first end 11c of the supporting part 10c. The size of the through hole 411c is limited to allow the first end 11c of the support part 10c to pass through the through hole 411c. Since the V-shaped structure has a space for the support part 10c to pass through, the entire elastic piece is accommodated inside the two clamping parts 31c, and the length of the first spring arm 412c is relatively short, which reduces the overall specification of the elastic piece.
实施例五Embodiment five
如图25所示，本发明第五实施例的瓣膜夹持装置100d与第四实施例中的瓣膜夹持装置100d大体上相同，其包括一个管状的支撑部10d，一个主体部20d，一个夹持部30d，以及一个驱动部40d。支撑部10d包括两个相对的第一端11d以及第二端12d，夹持部30d包括两个相对设置于主体部20d两侧的夹持件31d。驱动部40包括一个闭合单元41d和打开单元42d。As shown in FIG. 25, the valve clamping device 100d of the fifth embodiment of the present invention is substantially the same as the valve clamping device 100d of the fourth embodiment, which includes a tubular support part 10d, a main body part 20d, and a clip holding part 30d, and a driving part 40d. The supporting portion 10d includes two opposite first ends 11d and second ends 12d, and the clamping portion 30d includes two clamping pieces 31d oppositely disposed on two sides of the main body 20d. The drive section 40 includes a closing unit 41d and an opening unit 42d.
打开单元42d包括第三枢轴425d，第三枢轴425d上连接有推拉杆424d，该推拉杆424d容设于支撑部10d内部，用于与输送系统500的推拉机构52(参见图27)相连。闭合单元41d为V型弹片，V型结构中部设有用于使支撑部10d第一端11d穿过的通孔(参见图27)。The opening unit 42d includes a third pivot 425d, and a push-pull rod 424d is connected to the third pivot 425d, and the push-pull rod 424d is accommodated inside the support portion 10d, and is used to be connected with the push-pull mechanism 52 of the delivery system 500 (see FIG. 27 ). . The closing unit 41d is a V-shaped elastic piece, and a through hole is provided in the middle of the V-shaped structure for passing the first end 11d of the supporting part 10d (see FIG. 27 ).
不同之处在于，第一端11d穿过V形弹片上的通孔(未图示)形成连接头13d。该连接头13d优选采用设置于第一端11d周面的外螺纹，用于实现与输送系统500的内鞘管51(参见图27)的可拆卸连接。同时，不同之处还包括，推拉杆424d远离第三枢轴425d的一端是朝向第一端11d所在的方向延伸的，其通过螺纹连接的方式与输送系统500推拉机构52(参见图27)相连。The difference is that the first end 11d passes through a through hole (not shown) on the V-shaped elastic piece to form a connecting head 13d. The connection head 13d preferably adopts an external thread provided on the peripheral surface of the first end 11d for detachable connection with the inner sheath tube 51 of the delivery system 500 (see FIG. 27 ). At the same time, the difference also includes that the end of the push-pull rod 424d away from the third pivot 425d extends toward the direction where the first end 11d is located, and it is connected with the push-pull mechanism 52 of the delivery system 500 through a threaded connection (see FIG. 27 ). .
实施例六Embodiment six
如图26所示，本发明第六实施例提供的瓣膜夹持装置100e与第三实施例中的瓣膜夹持装置100c大体上相同，其包括一个支撑部10e，一个主体部20e，一个夹持部30e，以及一个驱动部40e。支撑部10e包括两个相对的第一端11e以及第二端12e。夹持部30e包括两个相对设置于主体部20e两侧的夹持件31e。驱动部40e包括一个闭合单元41e和打开单元42e。打开单元42e包括第三枢轴425e，第三枢轴425e上连接有推拉杆424e，该推拉杆424e容设于支撑部10e内部，用于与输送系统500的推拉机构52(参见图27)相连。闭合单元41e为设置于两个夹持件31e之间的扭簧，该扭簧的簧体包括间隔设置的第一环形件以及第二环形件(未标号)。As shown in Figure 26, the valve clamping device 100e provided by the sixth embodiment of the present invention is substantially the same as the valve clamping device 100c in the third embodiment, which includes a support part 10e, a main body part 20e, a clamping Part 30e, and a drive part 40e. The supporting portion 10e includes two opposite first ends 11e and second ends 12e. The clamping portion 30e includes two clamping pieces 31e oppositely disposed on two sides of the main body portion 20e. The driving part 40e includes a closing unit 41e and an opening unit 42e. The opening unit 42e includes a third pivot 425e, the third pivot 425e is connected with a push-pull rod 424e, and the push-pull rod 424e is accommodated inside the support part 10e, and is used to be connected with the push-pull mechanism 52 (see FIG. 27 ) of the delivery system 500 . The closing unit 41e is a torsion spring disposed between the two clamping parts 31e, and the spring body of the torsion spring includes a first ring part and a second ring part (not labeled) arranged at intervals.
不同之处在于，第一端11e穿过第一环形件以及第二环形件(未标号)之间的间隔形成连接头13e。该连接头13e优选采用设置于第一端11e周面的外螺纹，用于实现与输送系统500的内鞘管51(参见图27)可拆卸连接。同时，不同之处还包括，推拉杆424e远离第三枢轴425e的一端是朝向第一端11e所在的方向延伸的，其通过螺纹连接的方式与输送系统500推拉机构52(参见图27)相连。The difference is that the first end 11e passes through the space between the first ring part and the second ring part (not numbered) to form a connection head 13e. The connection head 13e preferably adopts an external thread provided on the peripheral surface of the first end 11e, for detachable connection with the inner sheath tube 51 of the delivery system 500 (see FIG. 27 ). At the same time, the difference also includes that the end of the push-pull rod 424e away from the third pivot 425e extends toward the direction where the first end 11e is located, which is connected to the push-pull mechanism 52 of the delivery system 500 (see FIG. 27 ) through a threaded connection. .
请一并参见图27以及图28，在第五、第六两个实施例中，是通过心尖穿刺的方式将瓣膜夹持装置输送至人体中的。以第五实施例的瓣膜夹持装置100d为例，具体操作过程如下：通过心尖穿刺的方式通过输送系统500将瓣膜夹持装置输送至左心室中使瓣膜夹持装置置于靠近二尖瓣位置，此时输送系统500的内鞘管51与连接头13d相连，输送系统500的推拉机构52与推拉杆424d相连，瓣膜夹持装置100d容置于外鞘管50内部；回撤外鞘管50使瓣膜夹持装置100d从外鞘管50中伸出；进一步，在三维超声的引导下，通过输送系统500的推拉机构52拉动第三枢轴425d使两个夹持件31d相对打开；之后向左心房推动瓣膜夹持装置100d使两个夹持件31d锚定件33d所在的一侧表面分别与两个瓣叶的下表面接触，且使两个瓣叶位于主体部20d和夹持部30d之间；解除推拉机构52对第三枢轴425d的拉动作用，两个夹持件31d在闭合单元41d的作用下相对闭合，锚定件33d穿过瓣膜组织，且锚定件33d穿过瓣膜的部分插入到主体部20d的定位槽或定位孔(未标号)中。由于主体部20d为弹性件，主体部20d在夹持件31d的作用下受力发生弹性形变，对夹持件31d提供一个径向支撑力，使瓣膜被紧紧夹持于夹持件31d和主体部20d之间，此时，二尖瓣的两个瓣叶之间的空隙由一个较大的空隙分隔成较小的两个空隙，从而减少了二尖瓣反流。Please refer to FIG. 27 and FIG. 28 together. In the fifth and sixth embodiments, the valve clamping device is delivered to the human body through apical puncture. Taking the valve clamping device 100d of the fifth embodiment as an example, the specific operation process is as follows: the valve clamping device is delivered to the left ventricle through the delivery system 500 by means of apical puncture so that the valve clamping device is placed close to the mitral valve , at this time, the inner sheath tube 51 of the delivery system 500 is connected to the connector 13d, the push-pull mechanism 52 of the delivery system 500 is connected to the push-pull rod 424d, and the valve clamping device 100d is accommodated inside the outer sheath tube 50; the outer sheath tube 50 is withdrawn Make the valve clamping device 100d protrude from the outer sheath tube 50; further, under the guidance of three-dimensional ultrasound, pull the third pivot 425d through the push-pull mechanism 52 of the delivery system 500 to make the two clamping parts 31d relatively open; The left atrium pushes the valve clamping device 100d so that the side surfaces where the two clamping parts 31d and the anchoring parts 33d are located are respectively in contact with the lower surfaces of the two valve leaflets, and the two valve leaflets are positioned between the main body part 20d and the clamping part 30d Between; release the pulling effect of the push-pull mechanism 52 on the third pivot 425d, the two clamping parts 31d are relatively closed under the action of the closing unit 41d, the anchoring part 33d passes through the valve tissue, and the anchoring part 33d passes through the valve Parts of the body are inserted into positioning grooves or positioning holes (not numbered) of the main body 20d. Since the main body part 20d is an elastic member, the main body part 20d is elastically deformed under the force of the clamping part 31d, and provides a radial support force for the clamping part 31d, so that the valve is tightly clamped between the clamping part 31d and the clamping part 31d. Between the main body 20d, at this time, the space between the two leaflets of the mitral valve is divided into two smaller spaces by a larger space, thereby reducing mitral valve regurgitation.
请再次参见图13至图14，以及图27至图28，本发明还提供一种用于输送瓣膜夹持装置的输送系统500，其包括一个外鞘管50，一个内鞘管51、以及一个推拉机构52；所述外鞘管50套设于所述内鞘管51外侧且可相对所述内鞘管51轴向移动；所述内鞘管51套设于推拉机构52的外侧可相对所述推拉机构52轴向移动。Please refer to Fig. 13 to Fig. 14 again, and Fig. 27 to Fig. 28, the present invention also provides a delivery system 500 for delivering a valve holding device, which includes an outer sheath 50, an inner sheath 51, and a Push-pull mechanism 52; the outer sheath 50 is sleeved on the outside of the inner sheath 51 and can move axially relative to the inner sheath 51; the inner sheath 51 is sleeved on the outside of the push-pull mechanism 52 and can move relatively The push-pull mechanism 52 moves axially.
以第一实施例为例进行说明，外鞘管50用于使瓣膜夹持装置100在输送至人体的过程中容置于其中，所述内鞘管51与所述瓣膜夹持装置100的支撑部10相连，用于将容置于外鞘管50中的瓣膜夹持装置10从外鞘管50中释放；所述推拉机构52与夹持部30相连，用于驱动所述夹持部30相对所述主体部20开合。Taking the first embodiment as an example, the outer sheath 50 is used to accommodate the valve holding device 100 in the process of delivery to the human body, and the inner sheath 51 and the support of the valve holding device 100 part 10, for releasing the valve clamping device 10 accommodated in the outer sheath 50 from the outer sheath 50; the push-pull mechanism 52 is connected with the clamping part 30, for driving the clamping part 30 Open and close relative to the main body part 20 .
内鞘管51设有上第一连接部(未标号),该第一连接部为设置于内鞘管51端部的内螺纹，该第一连接部与瓣膜夹持装置的连接头13上的外螺纹可拆卸相连；推拉机构52包括第二连接部(未标号),第二连接部与推拉杆424相连。通过内鞘管51固定支撑部10，推动或者拉动推拉机52，打开单元42在推拉杆424的作用下带动夹持件31相对主体部20开合。The inner sheath 51 is provided with an upper first connecting portion (not labeled), which is an internal thread arranged at the end of the inner sheath 51, and the first connecting portion is connected to the connecting head 13 of the valve clamping device. The external threads are detachably connected; the push-pull mechanism 52 includes a second connecting portion (not labeled), and the second connecting portion is connected with the push-pull rod 424 . The support part 10 is fixed by the inner sheath tube 51 , the push-pull machine 52 is pushed or pulled, and the opening unit 42 drives the clamping part 31 to open and close relative to the main body part 20 under the action of the push-pull rod 424 .
需要说明的是，该推拉机构52具有一定的刚性，优选选择钢缆作为推拉机构52。It should be noted that, the push-pull mechanism 52 has a certain rigidity, and a steel cable is preferably selected as the push-pull mechanism 52 .
综上所述，采用本发明的瓣膜夹持装置，可通过将瓣膜夹持于夹持部主体部之间的方式修复瓣膜，结构简单，同时不需要对主体部进行操作就能达到夹紧瓣膜的目的，使用方便。In summary, with the valve clamping device of the present invention, the valve can be repaired by clamping the valve between the main parts of the clamping part, the structure is simple, and the valve can be clamped without operating the main part. purpose, easy to use.
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，这些均属于本发明的保护之内。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 implementations, and the above-mentioned specific implementations are only illustrative, rather than restrictive. Those of ordinary skill in the art will Under the enlightenment of the present invention, many forms can also be made without departing from the gist of the present invention and the protection scope of the claims, and these all belong to the protection of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510561057.3ACN106491245B (en) | 2015-09-06 | 2015-09-06 | Valve clamping device |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510561057.3ACN106491245B (en) | 2015-09-06 | 2015-09-06 | Valve clamping device |
| Publication Number | Publication Date |
|---|---|
| CN106491245A CN106491245A (en) | 2017-03-15 |
| CN106491245Btrue CN106491245B (en) | 2018-08-07 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510561057.3AActiveCN106491245B (en) | 2015-09-06 | 2015-09-06 | Valve clamping device |
| Country | Link |
|---|---|
| CN (1) | CN106491245B (en) |
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| EP4454608A4 (en)* | 2021-12-23 | 2025-04-30 | Hangzhou Valgen Medtech Co., Ltd. | VALVE CLAMPING DEVICE |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP4454608A4 (en)* | 2021-12-23 | 2025-04-30 | Hangzhou Valgen Medtech Co., Ltd. | VALVE CLAMPING DEVICE |
| Publication number | Publication date |
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| CN106491245A (en) | 2017-03-15 |
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| TR01 | Transfer of patent right | Effective date of registration:20240103 Address after:518051 1604, Xianjian technology building, No. 22, Keji South 12th Road, gaoxinyuan community, Yuehai street, Nanshan District, Shenzhen, Guangdong Province Patentee after:Shenzhen Jianxin Medical Technology Co.,Ltd. Address before:518000 1st-5th Floor of Saiba Research Building, Langshan Second Road, North District of Nanshan High-tech Industrial Park, Shenzhen City, Guangdong Province Patentee before:LIFETECH SCIENTIFIC (SHENZHEN) Co.,Ltd. | |
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