技术领域Technical Field
本发明涉及医疗器械领域，尤其涉及一种易夹持的瓣膜夹合器及瓣膜夹合系统。The present invention relates to the field of medical devices, and in particular to an easy-to-clamp valve clamp and a valve clamp system.
背景技术Background Art
请参阅图1，二尖瓣1是位于心脏左心房2与左心室3之间的单向阀，正常健康的二尖瓣1可以控制血液从左心房2流到左心室3，同时避免血液从左心室3流到左心房2。二尖瓣包括一对瓣叶，称为前叶1a及后叶1b。前叶1a及后叶1b通过腱索4固定于左心室3的内壁上。正常情况下，心脏左心室收缩时，前叶1a和后叶1b的边缘完全对合，避免血液从左心室3流到左心房2。请参阅图2，当二尖瓣的瓣叶或其相关结构发生器质性改变或功能性改变(如腱索4)部分断裂时，二尖瓣的前叶1a和后叶1b对合不良，当心脏左心室收缩时，二尖瓣1不能完全关闭，导致血液从左心室3反流至左心房2，从而引起一系列的病理生理改变，称为“二尖瓣反流”。Please refer to FIG1 . The mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart. A normal and healthy mitral valve 1 can control the blood flow from the left atrium 2 to the left ventricle 3 and prevent the blood from flowing from the left ventricle 3 to the left atrium 2. The mitral valve includes a pair of leaflets, namely the anterior leaflet 1a and the posterior leaflet 1b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to the inner wall of the left ventricle 3 by the tendinea 4. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to FIG2 . When the leaflets of the mitral valve or its related structures undergo organic or functional changes (such as partial rupture of the tendinea 4), the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are not aligned properly. When the left ventricle of the heart contracts, the mitral valve 1 cannot be completely closed, resulting in blood flowing back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathological and physiological changes, which are called "mitral valve regurgitation".
现有一种微创治疗手术，将瓣叶夹钳通过输送装置输送至二尖瓣处，再通过夹钳的相对开合同时夹住二尖瓣的前叶和后叶，使得二尖瓣的前叶与后叶固定从而达到减少二尖瓣反流的目的。但是，由于二尖瓣的两个瓣叶始终处于大幅度、大力度的开合活动状态，夹钳快速、成功地捕获活动的瓣叶组织的难度较大，手术时间较长。There is a minimally invasive treatment surgery that delivers a leaflet clamp to the mitral valve through a delivery device, and then clamps the anterior and posterior leaflets of the mitral valve at the same time through the relative opening of the clamp, so that the anterior and posterior leaflets of the mitral valve are fixed to achieve the purpose of reducing mitral regurgitation. However, since the two leaflets of the mitral valve are always in a state of large-scale and strong opening and closing activities, it is difficult for the clamp to quickly and successfully capture the active leaflet tissue, and the operation time is long.
发明内容Summary of the invention
本发明的目的在于，针对上述现有技术的缺陷，提供一种易夹持的瓣膜夹合器及瓣膜夹合系统，所述易夹持的瓣膜夹合器能够容易快速地捕获活动的瓣叶组织，从而降低手术难度、提高手术效率。The object of the present invention is to provide an easy-to-clamp valve clamp and a valve clamp system to address the defects of the above-mentioned prior art. The easy-to-clamp valve clamp can easily and quickly capture active leaflet tissue, thereby reducing the difficulty of surgery and improving surgical efficiency.
所述易夹持的瓣膜夹合器，包括推杆、至少两个钳臂、至少一根延伸臂。所述钳臂包括固定端及自由端，所述固定端与所述推杆连接，所述推杆轴向移动以带动所述钳臂以所述固定端为旋转中心相对所述推杆开合；所述延伸臂沿所述钳臂的轴向伸长或缩回，当所述延伸臂沿钳臂的固定端向自由端方向伸长时，所述延伸臂的末端超出所述钳臂的自由端。The easy-to-hold valve clamp comprises a push rod, at least two clamp arms, and at least one extension arm. The clamp arm comprises a fixed end and a free end, the fixed end is connected to the push rod, the push rod moves axially to drive the clamp arm to open and close relative to the push rod with the fixed end as the rotation center; the extension arm extends or retracts along the axial direction of the clamp arm, and when the extension arm extends along the fixed end of the clamp arm toward the free end, the end of the extension arm exceeds the free end of the clamp arm.
所述瓣膜夹合系统包括推送装置及上述易夹持的瓣膜夹合器，所述推送装置包括操作手柄及具有一定轴向长度的推送轴，所述推送轴近端与所述操作手柄连接，所述推送轴的远端与所述瓣膜夹合器之间可拆卸连接。The valve clamping system includes a pushing device and the above-mentioned easy-to-clamp valve clamp, the pushing device includes an operating handle and a pushing shaft with a certain axial length, the proximal end of the pushing shaft is connected to the operating handle, and the distal end of the pushing shaft is detachably connected to the valve clamp.
本发明提供的易夹持的瓣膜夹合器及瓣膜夹合系统，通过设置可以沿钳臂的轴向伸长或缩回的延伸臂，使得钳臂相对推杆打开时，延伸臂的末端超出钳臂的自由端，相当于增加了钳臂在捕捉瓣叶时的长度，较长的钳臂能够在捕捉瓣叶时对瓣叶起到较好的承托效果，避免瓣叶从钳臂表面滑脱，从而快速地捕获活动的瓣叶组织，降低手术难度、提高手术效率。The easy-to-clamp valve clamp and valve clamp system provided by the present invention are equipped with an extension arm that can be extended or retracted along the axial direction of the clamp arm, so that when the clamp arm is opened relative to the push rod, the end of the extension arm exceeds the free end of the clamp arm, which is equivalent to increasing the length of the clamp arm when capturing the leaflet. The longer clamp arm can provide better support for the leaflet when capturing the leaflet, preventing the leaflet from slipping off the surface of the clamp arm, thereby quickly capturing the active leaflet tissue, reducing the difficulty of surgery and improving surgical efficiency.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为更清楚地阐述本发明的构造特征和功效，下面结合附图与具体实施例来对其进行详细说明。In order to more clearly illustrate the structural features and effects of the present invention, it is described in detail below in conjunction with the accompanying drawings and specific embodiments.
图1是二尖瓣正常状态时的示意图；FIG1 is a schematic diagram of the mitral valve in a normal state;
图2是二尖瓣出现病变时的示意图；FIG2 is a schematic diagram of a mitral valve with pathological changes;
图3是本发明一实施例的易夹持的瓣膜夹合器收拢时的结构示意图；FIG3 is a schematic structural diagram of an easy-to-hold valve clipper according to an embodiment of the present invention when it is folded;
图4是图3所示的瓣膜夹合器的钳臂张开时的一个视角下的结构示意图；FIG4 is a schematic structural diagram of the valve clip shown in FIG3 when the clamp arms are opened from one viewing angle;
图5是图3所示的瓣膜夹合器的钳臂张开时的另一个视角下的结构示意图；FIG5 is a schematic structural diagram of the valve clip shown in FIG3 when the clamp arms are opened from another perspective;
图6是本发明所述瓣膜夹合器在二尖瓣处的位置示意图；FIG6 is a schematic diagram of the position of the valve clip of the present invention at the mitral valve;
图7a是本发明所述瓣膜夹合器夹持瓣叶后，心脏收缩时二尖瓣示意图；FIG7a is a schematic diagram of the mitral valve during heart contraction after the valve clip of the present invention clamps the valve leaflets;
图7b是本发明所述瓣膜夹合器夹持瓣叶后，心脏舒张时二尖瓣示意图；FIG7 b is a schematic diagram of the mitral valve during diastole after the valve clip of the present invention clamps the valve leaflets;
图8是图3所示的瓣膜夹合器的推杆的结构示意图；FIG8 is a schematic structural diagram of a push rod of the valve clipper shown in FIG3 ;
图9是图3所示的瓣膜夹合器的固定基座的结构示意图；FIG9 is a schematic structural diagram of a fixed base of the valve clip shown in FIG3 ;
图10是图3所示的瓣膜夹合器的基座连接管的结构示意图；FIG10 is a schematic structural diagram of the base connecting tube of the valve clip shown in FIG3 ;
图11是图3所示的瓣膜夹合器的钳臂的结构示意图；FIG11 is a schematic structural diagram of the clamp arm of the valve clip shown in FIG3 ;
图12a是图3所示的瓣膜夹合器的夹持臂收拢时的结构示意图；FIG12a is a schematic structural diagram of the valve clipper shown in FIG3 when the clamping arms are folded;
图12b是图3所示的瓣膜夹合器的夹持臂张开时的结构示意图；FIG12b is a schematic structural diagram of the valve clip shown in FIG3 when the clamping arm is opened;
图13是图3所示的瓣膜夹合器的延伸臂的结构示意图；FIG13 is a schematic structural diagram of the extension arm of the valve clip shown in FIG3 ;
图14a至图14e是本发明不同实施例的瓣膜夹合器的延伸臂的承载部的结构示意图；14a to 14e are schematic structural diagrams of the bearing portion of the extension arm of the valve clip according to different embodiments of the present invention;
图15是图14c所示实施例的瓣膜夹合器的结构示意图；FIG15 is a schematic structural diagram of the valve clip of the embodiment shown in FIG14c;
图16是本申请另一实施例的瓣膜夹合器的结构示意图；FIG16 is a schematic structural diagram of a valve clipper according to another embodiment of the present application;
图17是图16所示实施例的瓣膜夹合器的钳臂的结构示意图；FIG17 is a schematic structural diagram of the clamp arm of the valve clip of the embodiment shown in FIG16;
图18是本申请另一实施例的瓣膜夹合器的钳臂的结构示意图；FIG18 is a schematic structural diagram of a clamp arm of a valve clipper according to another embodiment of the present application;
图19是本申请一实施例的瓣膜夹合器的钳臂处于张开状态时，所述瓣膜夹合器与所述推送轴连接时的结构示意图；19 is a schematic structural diagram of the valve clipper connected to the push shaft when the clamp arm of the valve clipper according to an embodiment of the present application is in an open state;
图20是图19所示的所述瓣膜夹合器与所述推送轴连接时的截面示意图；FIG20 is a cross-sectional schematic diagram of the valve clip shown in FIG19 when connected to the push shaft;
图21是本申请一实施例的瓣膜夹合器的钳臂处于收拢状态时，所述瓣膜夹合器与所述推送轴连接时的结构示意图；FIG21 is a schematic structural diagram of the valve clipper connected to the push shaft when the clamp arms of the valve clipper according to an embodiment of the present application are in a retracted state;
图22是图21所示的所述瓣膜夹合器与所述推送轴连接时的截面示意图。FIG. 22 is a cross-sectional schematic diagram of the valve clip shown in FIG. 21 when connected to the pushing shaft.
具体实施方式DETAILED DESCRIPTION
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述。其中，附图仅用于示例性说明，表示的仅是示意图，不能理解为对本专利的限制。需要强调的是，本申请中所说的“近端”是指靠近操作者的方向；“远端”是指远离操作者的方向。The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. The accompanying drawings are only used for illustrative purposes and represent only schematic diagrams, and cannot be understood as limitations on this patent. It should be emphasized that the "proximal end" mentioned in this application refers to the direction close to the operator; the "distal end" refers to the direction away from the operator.
请参阅图3至图5，本发明提供一种易夹持的瓣膜夹合器100。瓣膜夹合器100包括推杆40、两个钳臂11，至少一个延伸臂20。本实施例中，钳臂11的数量为两个，两个钳臂11以推杆40为轴对称设置并能够相对推杆40开合。本发明的瓣膜夹合器100可用于二尖瓣反流的缘对缘修复，具体的，请参阅图6，将瓣膜夹合器100置于二尖瓣的前叶及后叶的不能正常对合的位置，使得一个钳臂11承托二尖瓣的前叶1a边缘，另一个钳臂11承托二尖瓣的后叶1b边缘，通过两个钳臂11将二尖瓣的前叶1a及后叶1b的不能正常对合的位置固定在一起。图7a所示为心脏收缩时二尖瓣的状态示意图，其中，箭头方向为血流方向。当心脏收缩时，前叶1a与后叶1b靠拢，且前叶1a边缘与后叶1b边缘通过瓣膜夹合器100夹合，使得二尖瓣能够完全关闭或者开口的面积变小，从而减轻或治疗“二尖瓣反流”。请参阅图7b，图7b所示为心脏舒张时二尖瓣的状态示意图，其中，箭头方向为血流方向。当心脏舒张时，前叶1a及后叶1b仅在瓣膜夹合器100夹合的位置固定在一起，前叶1a及后叶1b其它的位置仍然正常舒张，使得大量血液能够从左心房进入左心室，从而保证血液的正常流动。本发明的其它实施例的瓣膜夹合器100也能够用于减轻或者治疗“三尖瓣反流”，即瓣膜夹合器100的钳臂11为三个，通过三个钳臂11将三个瓣叶固定在一起，从而减轻或者避免“三尖瓣反流”。其原理及结构与本发明实施例中用于解决二尖瓣反流的瓣膜夹合器100的原理及结构相同，在此不进行赘述。可以理解的是，本发明的其它实施例的瓣膜夹合器100还可以应用于其它需要将几个片状的组织夹合在一起的其它微创外科手术中，且钳臂11的数量根据实际使用需求进行变化。Please refer to Figures 3 to 5. The present invention provides a valve clip 100 that is easy to clamp. The valve clip 100 includes a push rod 40, two clamp arms 11, and at least one extension arm 20. In this embodiment, there are two clamp arms 11, which are symmetrically arranged with the push rod 40 as an axis and can be opened and closed relative to the push rod 40. The valve clip 100 of the present invention can be used for edge-to-edge repair of mitral valve regurgitation. Specifically, please refer to Figure 6. The valve clip 100 is placed at a position where the anterior leaflet and the posterior leaflet of the mitral valve cannot be normally aligned, so that one clamp arm 11 supports the edge of the anterior leaflet 1a of the mitral valve, and the other clamp arm 11 supports the edge of the posterior leaflet 1b of the mitral valve. The positions where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot be normally aligned are fixed together by the two clamp arms 11. Figure 7a shows a schematic diagram of the state of the mitral valve during heart contraction, wherein the arrow direction is the blood flow direction. When the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b are brought together, and the edge of the anterior leaflet 1a and the edge of the posterior leaflet 1b are clamped by the valve clamp 100, so that the mitral valve can be completely closed or the opening area becomes smaller, thereby alleviating or treating "mitral valve regurgitation". Please refer to Figure 7b, which is a schematic diagram of the state of the mitral valve during diastole, wherein the arrow direction is the blood flow direction. When the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are only fixed together at the position where the valve clamp 100 clamps, and the other positions of the anterior leaflet 1a and the posterior leaflet 1b are still normally diastolic, so that a large amount of blood can enter the left ventricle from the left atrium, thereby ensuring the normal flow of blood. The valve clamp 100 of other embodiments of the present invention can also be used to alleviate or treat "tricuspid valve regurgitation", that is, the valve clamp 100 has three clamp arms 11, and the three valve leaflets are fixed together by the three clamp arms 11, thereby alleviating or avoiding "tricuspid valve regurgitation". Its principle and structure are the same as those of the valve clip 100 for solving mitral valve regurgitation in the embodiment of the present invention, and will not be described in detail here. It is understandable that the valve clip 100 of other embodiments of the present invention can also be applied to other minimally invasive surgical operations that require clamping several sheets of tissue together, and the number of forceps arms 11 varies according to actual use requirements.
请一并参阅图3及图8，推杆40为杆状结构，通过推杆40沿轴向移动以推动钳臂11相对推杆40进行开合，以及带动延伸臂20运动，以实现延伸臂20的远端伸出或者缩回钳臂11。图8所示为本申请一实施例的推杆40的结构。推杆40包括圆杆段41以及连接于圆杆段41远端的方杆段42。其中，圆杆段41的轴向方向上的任意位置的截面为圆形，方杆段42轴向方向上的任意位置的截面为方形。推杆40的方杆段42的相对的两个表面上设有齿条421。其中，齿条421即是指方杆段42的表面上形成的凹凸的齿状结构。推杆40的近端环设有卡槽411。圆杆段41的近端环设有环槽411，且圆杆段41的近端的端面上向推杆40的内部方向设有螺纹孔412。可以理解的是，一些实施例中，所述推杆40也可以为圆杆或者方杆，即推杆40的轴向方向上的任意位置的截面均为圆形或者方形。Please refer to FIG. 3 and FIG. 8 together. The push rod 40 is a rod-shaped structure. The push rod 40 moves axially to push the clamp arm 11 to open and close relative to the push rod 40, and drives the extension arm 20 to move, so that the distal end of the extension arm 20 extends or retracts the clamp arm 11. FIG. 8 shows the structure of the push rod 40 of an embodiment of the present application. The push rod 40 includes a round rod segment 41 and a square rod segment 42 connected to the distal end of the round rod segment 41. The cross section of the round rod segment 41 at any position in the axial direction is circular, and the cross section of the square rod segment 42 at any position in the axial direction is square. Racks 421 are provided on two opposite surfaces of the square rod segment 42 of the push rod 40. The rack 421 refers to the concave and convex toothed structure formed on the surface of the square rod segment 42. A slot 411 is provided at the proximal ring of the push rod 40. The proximal end of the round rod segment 41 is provided with an annular groove 411, and the proximal end surface of the round rod segment 41 is provided with a threaded hole 412 in the inner direction of the push rod 40. It can be understood that in some embodiments, the push rod 40 can also be a round rod or a square rod, that is, the cross section of any position in the axial direction of the push rod 40 is round or square.
本申请的一些实施例中，所述推杆40的远端上设有基座43。其中，基座43包括相对的两个第一表面431及连接两个第一表面431的第二表面432。所述推杆40的远端固定于所述第二表面432上，两个第一表面上431上均设有一个缺口433。缺口433相对的两侧内壁上设有销钉孔434。In some embodiments of the present application, a base 43 is provided on the distal end of the push rod 40. The base 43 includes two opposite first surfaces 431 and a second surface 432 connecting the two first surfaces 431. The distal end of the push rod 40 is fixed on the second surface 432, and a notch 433 is provided on each of the two first surfaces 431. Pin holes 434 are provided on the inner walls on both sides opposite to the notch 433.
基座43外表面光滑，从而便于基座43在瓣膜夹合器100能够顺利的推进，并避免基座43损伤人体组织或钩挂腱索。基座43可以为任意形状的结构，例如长方体、半球体、球冠、弹头形等结构。本实施例中，基座43为长方体形状。优选地，基座43的平行于第二平面412方向的截面尺寸由近端至远端逐渐减小，使得瓣膜夹合器100更容易在体内进行推进。The outer surface of the base 43 is smooth, so that the base 43 can be smoothly pushed forward in the valve clip 100, and the base 43 is prevented from damaging human tissue or hooking the tendon. The base 43 can be a structure of any shape, such as a rectangular parallelepiped, a hemispherical body, a spherical cap, a bullet-shaped structure, etc. In this embodiment, the base 43 is a rectangular parallelepiped. Preferably, the cross-sectional dimension of the base 43 parallel to the second plane 412 gradually decreases from the proximal end to the distal end, so that the valve clip 100 is easier to push in the body.
推杆40及基座43由生物相容性材料制成。生物相容性材料选自不锈钢、钴合金或钛合金，优选为钛合金。The push rod 40 and the base 43 are made of a biocompatible material, which is selected from stainless steel, cobalt alloy or titanium alloy, preferably titanium alloy.
请参阅图3及图9，本申请的一些实施例中，瓣膜夹合器100还包括固定基座50。图9所示为本申请一实施例的固定基座50的结构示意图。固定基座50包括两块相对的夹板51，两块夹板51通过两根间隔设置的连接杆52连接。两根连接杆52与两块夹板51围成穿设通道53，推杆40插入穿设通道53中，并能够在穿设通道53内进行轴向移动。Referring to FIG. 3 and FIG. 9 , in some embodiments of the present application, the valve clipper 100 further includes a fixed base 50. FIG. 9 is a schematic structural diagram of a fixed base 50 according to an embodiment of the present application. The fixed base 50 includes two opposing clamps 51, and the two clamps 51 are connected by two spaced connecting rods 52. The two connecting rods 52 and the two clamps 51 form a through-channel 53, and the push rod 40 is inserted into the through-channel 53 and can move axially in the through-channel 53.
请参阅图3及图10，本申请一些实施例中，瓣膜夹合器100还包括基座连接管60，基座连接管60套设于推杆40的外部并与固定基座50固定。基座连接管60上设有一开孔61，开孔61内设有一弹片62。弹片62包括连接端以及与连接端相对的自由端，连接端连接于开孔61边缘。自然状态下，自由端相对连接段朝向基座连接管60的内部倾斜。钳臂11收拢于推杆40上时，弹片62的自由端卡入于推杆40的近端的卡槽411内，阻止推杆40沿轴向的移动，以避免钳臂11相对推杆40打开。Please refer to FIG. 3 and FIG. 10 . In some embodiments of the present application, the valve clipper 100 further includes a base connecting tube 60, which is sleeved on the outside of the push rod 40 and fixed to the fixed base 50. The base connecting tube 60 is provided with an opening 61, and a spring piece 62 is provided in the opening 61. The spring piece 62 includes a connecting end and a free end opposite to the connecting end, and the connecting end is connected to the edge of the opening 61. In a natural state, the free end is inclined toward the inside of the base connecting tube 60 relative to the connecting section. When the clamp arm 11 is retracted on the push rod 40, the free end of the spring piece 62 is inserted into the clamping groove 411 at the proximal end of the push rod 40 to prevent the push rod 40 from moving in the axial direction, so as to prevent the clamp arm 11 from opening relative to the push rod 40.
进一步的，基座连接管60的近端设有连接部63，用于与推动瓣膜夹合器100至心脏瓣膜处的推送装置进行连接。本申请一些实施例中，连接部63为T型槽，T型槽包括第一槽段631以及与第一槽段631交叉的第二槽段632。其中，第一槽段631的延伸方向与基座连接管60的轴向相同，并从基座连接管60的近端的端面上向基座连接管60的近端的远端方向延伸形成。Furthermore, a connecting portion 63 is provided at the proximal end of the base connecting tube 60 for connecting with a pushing device for pushing the valve clip 100 to the heart valve. In some embodiments of the present application, the connecting portion 63 is a T-slot, and the T-slot includes a first slot section 631 and a second slot section 632 intersecting the first slot section 631. The extending direction of the first slot section 631 is the same as the axial direction of the base connecting tube 60, and is extended from the end surface of the proximal end of the base connecting tube 60 to the distal end of the proximal end of the base connecting tube 60.
请重新参阅图3至图5，钳臂11用于与夹持臂12或推杆40相对开合以夹紧或松开瓣叶。请一并参阅图8及图11，图11所示为本申请一些实施例中的钳臂11的结构示意图。每个钳臂11均包括位于远端的固定端11a及位于近端的自由端11b，钳臂11以固定端11a为旋转中心相对推杆40进行开合。具体的，钳臂11的固定端11a具有齿轮111，齿轮111与推杆40上的齿条421啮合。钳臂11的固定端11a位于固定基座50的两块夹板51之间，且齿轮111轴向旋转连接于两块夹板51上。具体的，齿轮111沿轴向设有贯通的销钉孔114，两块夹板51上对应设有固定孔54。销钉122穿过销钉孔114且销钉122的两端分别固定于夹板51的固定孔54内。由于齿轮111与齿条421的啮合，推杆40沿轴向进行移动时，齿轮111以销钉122为轴进行旋转，使得钳臂11以齿轮111为旋转中心相对推杆40进行旋转开合。具体的，当推杆40向远端进行轴向移动时，齿条421带动齿轮111转动，以使得钳臂11相对推杆40收拢；当推杆40向近端进行轴向移动时，齿条421带动齿轮111转动，以使得钳臂11相对推杆40打开。Please refer to Figures 3 to 5 again. The clamp arm 11 is used to open and close relative to the clamp arm 12 or the push rod 40 to clamp or loosen the leaflet. Please refer to Figures 8 and 11 together. Figure 11 shows a schematic diagram of the structure of the clamp arm 11 in some embodiments of the present application. Each clamp arm 11 includes a fixed end 11a located at the distal end and a free end 11b located at the proximal end. The clamp arm 11 opens and closes relative to the push rod 40 with the fixed end 11a as the rotation center. Specifically, the fixed end 11a of the clamp arm 11 has a gear 111, and the gear 111 is engaged with the rack 421 on the push rod 40. The fixed end 11a of the clamp arm 11 is located between the two clamp plates 51 of the fixed base 50, and the gear 111 is axially rotatably connected to the two clamp plates 51. Specifically, the gear 111 is provided with a through pin hole 114 along the axial direction, and the two clamp plates 51 are correspondingly provided with a fixing hole 54. The pin 122 passes through the pin hole 114 and both ends of the pin 122 are respectively fixed in the fixing holes 54 of the clamp plate 51. Due to the meshing of the gear 111 and the rack 421, when the push rod 40 moves axially, the gear 111 rotates with the pin 122 as the axis, so that the clamp arm 11 rotates and opens and closes relative to the push rod 40 with the gear 111 as the rotation center. Specifically, when the push rod 40 moves axially toward the distal end, the rack 421 drives the gear 111 to rotate, so that the clamp arm 11 is retracted relative to the push rod 40; when the push rod 40 moves axially toward the proximal end, the rack 421 drives the gear 111 to rotate, so that the clamp arm 11 is opened relative to the push rod 40.
本申请一些实施例中，两个钳臂11之间的夹角范围为0°至200°，即，初始状态(闭合)的两个钳臂之间平行，夹角为0°，而通过推杆40的齿条421与钳臂11的齿轮111的啮合，能够实现两个钳臂11之间较大范围的夹角张开幅度，张开的两个钳臂11之间的夹角最大可达到200°，通过设置齿轮111和齿条421的啮合的具体规格，优选两个张开的钳臂11之间的最大夹角为150°。钳口开口尺寸范围可达20-36mm，有利于夹持瓣叶。并且，两个钳臂11的张开及收拢均是匀速进行，利于操作者在夹持过程中根据瓣膜夹合器100与瓣叶之间的相对位置实时调整钳臂11的位置，避免夹持过快或者过慢导致瓣叶滑脱造成夹持失败。并且，通过推杆40的进给行程，能够得知与之对应的两个钳臂11之间夹角的大小，有利操作者的夹持判断。In some embodiments of the present application, the angle between the two clamp arms 11 ranges from 0° to 200°, that is, the two clamp arms in the initial state (closed) are parallel and the angle is 0°, and through the meshing of the rack 421 of the push rod 40 and the gear 111 of the clamp arm 11, a larger range of angle opening between the two clamp arms 11 can be achieved, and the angle between the two opened clamp arms 11 can reach a maximum of 200°. By setting the specific specifications of the meshing of the gear 111 and the rack 421, it is preferred that the maximum angle between the two opened clamp arms 11 is 150°. The jaw opening size range can reach 20-36mm, which is conducive to clamping the valve leaflets. In addition, the opening and closing of the two clamp arms 11 are both carried out at a uniform speed, which is conducive to the operator to adjust the position of the clamp arm 11 in real time according to the relative position between the valve clamp 100 and the valve leaflets during the clamping process, so as to avoid the valve leaflets slipping due to clamping too fast or too slow, resulting in clamping failure. Furthermore, the size of the angle between the two corresponding clamp arms 11 can be known through the feeding stroke of the push rod 40, which is helpful for the operator's clamping judgment.
可以理解的是，本申请的其他实施例中，两个钳臂11的固定端11a也可以通过销钉或螺栓等方式旋转连接于推杆40上，使得两个钳臂11能够相对推杆40进行旋转开合。It is understandable that in other embodiments of the present application, the fixed ends 11 a of the two clamp arms 11 may also be rotatably connected to the push rod 40 by means of pins or bolts, so that the two clamp arms 11 can be rotated to open and close relative to the push rod 40 .
一些实施例中，钳臂11上设有多个间隔设置的通孔。通过在钳臂11上设置所述通孔，能够减轻所述钳臂11的重量，并且能够有利于内皮细胞的爬覆及生长。In some embodiments, a plurality of through holes arranged at intervals are provided on the forceps arm 11. By providing the through holes on the forceps arm 11, the weight of the forceps arm 11 can be reduced, and the climbing and growth of endothelial cells can be facilitated.
钳臂11包括朝向推杆40的第一表面112a。一些实施例中，第一表面112a上设有夹持增强件113，使得钳臂11与推杆40配合夹紧瓣叶时，增强钳臂11与瓣叶之间的摩擦力，从而提供稳定的夹持力。其中，夹持增强件113可以为设于第一表面112a的凸起、凹槽或者贴合于第一表面112a的由摩擦系数较高的生物相容性材料制成的垫片。The clamp arm 11 includes a first surface 112a facing the push rod 40. In some embodiments, a clamping reinforcement 113 is provided on the first surface 112a, so that when the clamp arm 11 and the push rod 40 cooperate to clamp the leaflet, the friction between the clamp arm 11 and the leaflet is enhanced, thereby providing a stable clamping force. The clamping reinforcement 113 can be a protrusion or a groove provided on the first surface 112a, or a gasket made of a biocompatible material with a high friction coefficient and attached to the first surface 112a.
为了保证稳定的夹持力并适应瓣叶的大小，钳臂11具有一定的尺寸规定。具体的，当钳臂11过长时，钳臂11易将过多的前叶1a和后叶1b夹在一起，两个瓣叶被强行拉向彼此并固定在一起，不仅容易导致二尖瓣功能异常，并且在心脏跳动和瓣叶运动的时候，由于过多的瓣叶被限制运动，还可能导致瓣叶撕裂等严重后果；当钳臂11过短时，只能夹住小部分的瓣叶，使得瓣叶容易滑出，夹合固定效果较差。并且，由于瓣叶较为柔软，在夹持过程中，钳臂11不易承托瓣叶或与夹持臂12配合夹持瓣叶，延长手术时间。本申请一些实施例中，钳臂11的轴向长度(即固定端11a至自由端11b的距离)应大于或等于4mm，优选为6-10mm。并且，钳臂11的宽度也有一定的限制，以避免钳臂11的宽度过窄而对瓣叶产生伤害，同时也避免钳臂11的宽度过宽时对瓣叶运动的影响。钳臂11的宽度(即与钳臂11的轴向方向垂直的方向的长度)应大于或等于2mm，优选为4-6mm。并且，为了保证植入后的安全性，钳臂11应由生物相容性材料制成，并具有一定的柔性及刚性，从而避免钳臂11对瓣叶造成伤害，同时又能够夹紧固定瓣叶。具体地，生物相容性材料选自不锈钢、钴合金或钛合金。In order to ensure a stable clamping force and adapt to the size of the leaflets, the forceps arm 11 has certain size regulations. Specifically, when the forceps arm 11 is too long, the forceps arm 11 is easy to clamp too many anterior leaflets 1a and posterior leaflets 1b together, and the two leaflets are forcibly pulled toward each other and fixed together, which is not only easy to cause mitral valve dysfunction, but also when the heart beats and the leaflets move, too many leaflets are restricted from moving, which may also cause leaflet tearing and other serious consequences; when the forceps arm 11 is too short, only a small part of the leaflets can be clamped, making the leaflets easy to slip out, and the clamping and fixing effect is poor. In addition, since the leaflets are relatively soft, during the clamping process, the forceps arm 11 is not easy to support the leaflets or cooperate with the clamping arm 12 to clamp the leaflets, which prolongs the operation time. In some embodiments of the present application, the axial length of the forceps arm 11 (i.e., the distance from the fixed end 11a to the free end 11b) should be greater than or equal to 4mm, preferably 6-10mm. In addition, the width of the forceps arm 11 is also subject to certain restrictions, in order to avoid the forceps arm 11 being too narrow and causing damage to the valve leaflets, and also to avoid the influence on the movement of the valve leaflets when the forceps arm 11 is too wide. The width of the forceps arm 11 (i.e., the length in the direction perpendicular to the axial direction of the forceps arm 11) should be greater than or equal to 2 mm, preferably 4-6 mm. In addition, in order to ensure safety after implantation, the forceps arm 11 should be made of a biocompatible material and have a certain degree of flexibility and rigidity, so as to avoid the forceps arm 11 causing damage to the valve leaflets, while being able to clamp and fix the valve leaflets. Specifically, the biocompatible material is selected from stainless steel, cobalt alloy or titanium alloy.
进一步的，钳臂11的第一表面112a上还可以施加活性药物，或者设置多个开口，以促进瓣膜组织在钳臂11的内表面上的内皮细胞爬覆及生长。进一步的，第一表面112a也可以设置为具有凹凸结构的凹凸表面，从而增加钳臂11与瓣叶之间的摩擦力，提高瓣膜夹合器100对瓣叶的固定能力。Furthermore, active drugs may be applied to the first surface 112a of the forceps arm 11, or a plurality of openings may be provided to promote the endothelial cells of the valve tissue to crawl and grow on the inner surface of the forceps arm 11. Furthermore, the first surface 112a may also be provided as a concave-convex surface with a concave-convex structure, thereby increasing the friction between the forceps arm 11 and the valve leaflet, and improving the fixing ability of the valve clip 100 to the valve leaflet.
请重新参阅图3至图5，本申请一实施例中，瓣膜夹合器100包括具有弹性的夹持件，夹持件包括两个夹持臂12。夹持件的两个夹持臂12与两个钳臂11分别对应，且每个夹持臂12分别位于同其对应的一个钳臂11与推杆40之间，通过每个钳臂11与一个夹持臂12对合从而夹紧瓣叶。Please refer to Figures 3 to 5 again. In one embodiment of the present application, the valve clipper 100 includes an elastic clamping member, which includes two clamping arms 12. The two clamping arms 12 of the clamping member correspond to the two clamp arms 11, respectively, and each clamping arm 12 is located between a corresponding clamp arm 11 and the push rod 40, and each clamp arm 11 is matched with a clamp arm 12 to clamp the valve leaflet.
请一并参阅图3、图12a及图12b，图12a所示为本申请一些实施例的夹持件处于收紧(输送)状态下的结构示意图；图12b所示为本申请一些实施例的夹持件处于自然(释放)状态下的结构示意图。夹持件由镍钛合金或者钴铬合金的钣金等材料切割，然后放入到定型模具中，通过热定型处理得到图12b所示的形状。由于夹持件具有弹性，可通过图12a所示的状态在导管中输送，并在解除束缚后恢复至图12b所示的状态，从而与钳臂11配合夹紧瓣叶。夹持件的每个夹持臂12均包括相对设置的自由端12a及固定端12b。固定端12b固定于固定基座50上。一些实施例中，固定端12b固定于固定基座50与基座连接管60之间。一些实施例中，两个夹持臂12的固定端12b通过连接片12c连接为一体结构(即，夹持件呈U形)，并将连接片12c与固定基座50进行可拆卸或者不可拆卸固定连接，以实现两个夹持臂12的固定端12b与固定基座50的固定。本申请一些实施例中，夹持臂12至少部分由镍钛合金等弹性材料制成。本申请一实施例中，夹持臂12的固定端12b由弹性材料制成。夹持臂12的自由端12a可以由铝合金等非弹性材料制成，只要保证夹持臂12通过热定型，具有自然状态及收紧状态即可。自然状态下，夹持臂12与推杆40之间呈角度设置。两个夹持臂12之间的夹角范围为0°-160°。一些实施例中，两个夹持臂12之间的夹角应略大于两个钳臂11之间的夹角，以提供更稳定的夹持力，即，每个夹持臂12与推杆40之间的夹角大于或等于与该夹持臂12对应的钳臂11张开至最大状态时的钳臂11与推杆40之间的夹角，从而保证钳臂11与夹持臂12之间具有一定的夹紧力，以夹紧位于钳臂11与夹持臂12之间的瓣叶。可以理解的是，一些实施例中，夹持臂12与推杆40之间的夹角也可以小于钳臂11张开至最大状态时的钳臂11与推杆40之间的夹角。Please refer to Figure 3, Figure 12a and Figure 12b. Figure 12a shows a schematic diagram of the structure of the clamping member in some embodiments of the present application in a tightened (transporting) state; Figure 12b shows a schematic diagram of the structure of the clamping member in some embodiments of the present application in a natural (released) state. The clamping member is cut from sheet metal materials such as nickel-titanium alloy or cobalt-chromium alloy, and then placed in a shaping mold, and the shape shown in Figure 12b is obtained through heat setting treatment. Since the clamping member is elastic, it can be transported in the catheter in the state shown in Figure 12a, and after being released from the restraint, it returns to the state shown in Figure 12b, thereby cooperating with the clamp arm 11 to clamp the leaflet. Each clamping arm 12 of the clamping member includes a free end 12a and a fixed end 12b arranged opposite to each other. The fixed end 12b is fixed to the fixed base 50. In some embodiments, the fixed end 12b is fixed between the fixed base 50 and the base connecting tube 60. In some embodiments, the fixed ends 12b of the two clamping arms 12 are connected to form an integral structure (i.e., the clamping member is U-shaped) through a connecting piece 12c, and the connecting piece 12c is detachably or non-detachably fixedly connected to the fixed base 50 to achieve the fixation of the fixed ends 12b of the two clamping arms 12 to the fixed base 50. In some embodiments of the present application, the clamping arm 12 is at least partially made of an elastic material such as nickel-titanium alloy. In one embodiment of the present application, the fixed end 12b of the clamping arm 12 is made of an elastic material. The free end 12a of the clamping arm 12 can be made of a non-elastic material such as an aluminum alloy, as long as the clamping arm 12 is heat-set and has a natural state and a tightened state. In the natural state, the clamping arm 12 is set at an angle to the push rod 40. The angle between the two clamping arms 12 ranges from 0° to 160°. In some embodiments, the angle between the two clamping arms 12 should be slightly larger than the angle between the two clamping arms 11 to provide a more stable clamping force, that is, the angle between each clamping arm 12 and the push rod 40 is larger than or equal to the angle between the clamping arm 11 and the push rod 40 when the clamping arm 11 corresponding to the clamping arm 12 is opened to the maximum state, thereby ensuring that there is a certain clamping force between the clamping arm 11 and the clamping arm 12 to clamp the leaflet between the clamping arm 11 and the clamping arm 12. It is understandable that in some embodiments, the angle between the clamping arm 12 and the push rod 40 may also be smaller than the angle between the clamping arm 11 and the push rod 40 when the clamping arm 11 is opened to the maximum state.
夹持臂12的自由端12a与推送装置中的控制件13进行连接，通过控制件13控制夹持臂12的自由端12a，以调整夹持臂12与推杆40之间的角度以及夹持臂12与钳臂11之间的开合。本实施例中，控制件13为金属或者PTFE等高分子材料制成的调节线，调节线穿过夹持臂12的自由端12a，将夹持臂12束缚于推杆40的表面，使得两个夹持臂12处于收紧状态，利于通过导管经由弯曲的血管进行输送；当钳臂11与瓣叶的位置调整好后，放开调节线对夹持臂12的自由端12a的控制，夹持臂12的自由端12a由于自身的弹性记忆性能，向两侧回弹并远离推杆40，此时所述夹持臂12处于自然状态，并使得夹持臂12与钳臂11夹紧位于二者之间的瓣叶。The free end 12a of the clamp arm 12 is connected to the control member 13 in the pushing device, and the free end 12a of the clamp arm 12 is controlled by the control member 13 to adjust the angle between the clamp arm 12 and the push rod 40 and the opening and closing between the clamp arm 12 and the clamp arm 11. In this embodiment, the control member 13 is an adjustment wire made of a polymer material such as metal or PTFE, and the adjustment wire passes through the free end 12a of the clamp arm 12, and the clamp arm 12 is bound to the surface of the push rod 40, so that the two clamp arms 12 are in a tightened state, which is conducive to the delivery through the catheter through the curved blood vessel; when the position of the clamp arm 11 and the valve leaflet is adjusted, the control of the free end 12a of the clamp arm 12 by the adjustment wire is released, and the free end 12a of the clamp arm 12 rebounds to both sides and moves away from the push rod 40 due to its own elastic memory performance. At this time, the clamp arm 12 is in a natural state, and the clamp arm 12 and the clamp arm 11 clamp the valve leaflet located between them.
进一步的，夹持臂12包括与钳臂11相对的第三表面12d。第三表面12d上设有夹持增强件121，以增加夹持臂12与夹持于钳臂11与夹持臂12之间的瓣叶之间的摩擦力，提高钳臂11与夹持臂12对瓣叶的夹持力。夹持增强件121可以是凸设于第三表面12d的凸棱、倒钩、凸台或者其它不规则分布的凸起等结构，还可以是至少部分覆盖第三表面12d的粗糙表面，以提高瓣膜夹合器100对瓣叶的夹持力。例如，在推杆40外表面覆盖由摩擦系数较高的生物相容性材料制成的垫片，增加第三表面12d的表面粗糙系数，从而提高瓣膜夹合器100对瓣叶的夹持力。夹持增强件121还可以是设置在夹持臂12上的磁性体，此时，在钳臂11上也设置对应的磁性体，通过钳臂11与夹持臂12之间的相互磁性吸力，达到增强夹持力的目的。Further, the clamping arm 12 includes a third surface 12d opposite to the clamp arm 11. A clamping reinforcement 121 is provided on the third surface 12d to increase the friction between the clamping arm 12 and the leaflet clamped between the clamp arm 11 and the clamp arm 12, thereby improving the clamping force of the clamp arm 11 and the clamp arm 12 on the leaflet. The clamping reinforcement 121 can be a convex ridge, a barb, a boss, or other irregularly distributed protrusions convexly provided on the third surface 12d, or a rough surface at least partially covering the third surface 12d, thereby improving the clamping force of the valve clip 100 on the leaflet. For example, a gasket made of a biocompatible material with a high friction coefficient is covered on the outer surface of the push rod 40 to increase the surface roughness coefficient of the third surface 12d, thereby improving the clamping force of the valve clip 100 on the leaflet. The clamping reinforcement member 121 may also be a magnetic body arranged on the clamping arm 12 . In this case, a corresponding magnetic body is also arranged on the clamp arm 11 , and the purpose of enhancing the clamping force is achieved through the mutual magnetic attraction between the clamp arm 11 and the clamping arm 12 .
本申请一实施例中，夹持增强件121为两列间隔设置的凸齿。两列凸齿相对设置于夹持臂12的两侧边缘。并且，每个凸齿的轴向与第三表面12d之间的夹角小于或等于90°，以进一步增强夹持力。进一步的，凸齿远离第三表面12d的一端为光滑的弧形面，从而避免损伤瓣叶。本实施例中，由于夹持臂12上设有凸齿，因此，为了避免凸齿对钳臂11与夹持臂12对合的影响，钳臂11的宽度小于夹持臂12的宽度，使得钳臂11与夹持臂12对合时，夹持臂12上的凸齿均位于钳臂11的两侧，钳臂11的第一表面112a与夹持臂12的第三表面12d接触，使得钳臂11与夹持臂12能够更加稳定的夹紧位于钳臂11与夹持臂12之间的瓣叶。进一步的，一些实施例中，夹持臂12上设有通孔122，以减轻夹持臂12的重量，增强夹持臂12的弹性，并且利于内皮细胞的爬覆及生长。In one embodiment of the present application, the clamping reinforcement member 121 is two rows of convex teeth arranged at intervals. The two rows of convex teeth are arranged on the two side edges of the clamping arm 12 relatively. In addition, the angle between the axial direction of each convex tooth and the third surface 12d is less than or equal to 90°, so as to further enhance the clamping force. Furthermore, the end of the convex tooth away from the third surface 12d is a smooth arc surface, so as to avoid damaging the leaflet. In this embodiment, since the clamping arm 12 is provided with convex teeth, in order to avoid the influence of the convex teeth on the engagement of the clamp arm 11 and the clamp arm 12, the width of the clamp arm 11 is smaller than the width of the clamp arm 12, so that when the clamp arm 11 and the clamp arm 12 are engaged, the convex teeth on the clamp arm 12 are all located on both sides of the clamp arm 11, and the first surface 112a of the clamp arm 11 is in contact with the third surface 12d of the clamp arm 12, so that the clamp arm 11 and the clamp arm 12 can more stably clamp the leaflet located between the clamp arm 11 and the clamp arm 12. Furthermore, in some embodiments, a through hole 122 is provided on the clamping arm 12 to reduce the weight of the clamping arm 12 , enhance the elasticity of the clamping arm 12 , and facilitate the climbing and growth of endothelial cells.
请重新参阅图3至图5，延伸臂20为至少一根。延伸臂20设于钳臂11的表面或者内部。本申请一实施例中，延伸臂20为两根，分别设于两个钳臂11的表面。具体的，延伸臂20可以设于钳臂11的第一表面112a(即钳臂11的内表面)或者设于与第一表面112a相背的第二表面(即钳臂11的外表面)。一些实施例中，延伸臂20设于钳臂11的内部。具体的，钳臂11内设有从固定端11a向自由端11b方向延伸的穿孔，延伸臂20穿设于穿孔内，以使得延伸臂20设于钳臂11的内部。本实施例中，延伸臂20设于钳臂11的第二表面。具体的，钳臂11的第二表面上设有限位件14，限位件14用于限定延伸臂20的伸缩方向为沿钳臂11的固定端11a向自由端11b的方向，限制延伸臂20的径向偏移。限位件14可以为限位环、限位槽或者限位管等各种限位结构。优先的，限位件14为限位环或者限位管等，通过限位件14还能够将延伸臂20固定于钳臂11的第二表面，防止延伸臂20在运动过程中于第二表面脱离。具体的，本实施例中，限位件14为具有一定长度的管状件，延伸臂20可活动地穿设于管状件中。Please refer to Figures 3 to 5 again. There is at least one extension arm 20. The extension arm 20 is disposed on the surface or inside of the clamp arm 11. In one embodiment of the present application, there are two extension arms 20, which are respectively disposed on the surfaces of the two clamp arms 11. Specifically, the extension arm 20 can be disposed on the first surface 112a of the clamp arm 11 (i.e., the inner surface of the clamp arm 11) or on the second surface opposite to the first surface 112a (i.e., the outer surface of the clamp arm 11). In some embodiments, the extension arm 20 is disposed inside the clamp arm 11. Specifically, a through hole extending from the fixed end 11a to the free end 11b is provided inside the clamp arm 11, and the extension arm 20 is penetrated in the through hole so that the extension arm 20 is disposed inside the clamp arm 11. In this embodiment, the extension arm 20 is disposed on the second surface of the clamp arm 11. Specifically, a limiter 14 is provided on the second surface of the clamp arm 11, and the limiter 14 is used to limit the telescopic direction of the extension arm 20 to the direction from the fixed end 11a of the clamp arm 11 to the free end 11b, so as to limit the radial displacement of the extension arm 20. The limiter 14 can be various limiter structures such as a limiter ring, a limiter groove or a limiter tube. Preferably, the limiter 14 is a limiter ring or a limiter tube, etc., and the extension arm 20 can also be fixed to the second surface of the clamp arm 11 through the limiter 14 to prevent the extension arm 20 from detaching from the second surface during movement. Specifically, in this embodiment, the limiter 14 is a tubular member with a certain length, and the extension arm 20 can be movably inserted into the tubular member.
请参阅图13，本申请一些实施例中，延伸臂20包括相对的固定端20a以及自由端20b，固定端20a旋转固定于推杆40的远端。本申请一实施例中，固定端20a旋转固定于推杆40的远端的基座43上。延伸臂20的固定端20a位于基座43上的缺口411内。并且固定端20a上具有销钉孔114，销钉穿过销钉孔114且销钉的两端固定于缺口411的内壁，从而实现固定端20a与基座43的旋转固定。当沿轴向推动推杆40时，推杆40带动延伸臂20的末端超出钳臂11的自由端11a。具体的，当推杆40向远端进行轴向移动时，能够带动延伸臂20的末端沿钳臂11的轴向缩回；当推杆40向近端进行轴向移动时，能够带动延伸臂20的末端沿钳臂11的轴向伸长。同时，本申请一些实施例中，由于推杆40的轴向移动能够带动钳臂11相对推杆40进行开合，从而能够实现通过轴向移动推杆40，同时控制钳臂11相对推杆40的开合以及延伸臂20沿钳臂11的轴向伸长及缩回，从而在不增加额外的手术操作步骤的前提下同时实现钳臂11相对推杆40的开合控制以及延伸臂20相对钳臂11的轴向伸长及收缩控制，降低手术难度。可以理解的是，本申请的其他实施例中，延伸臂20的伸长或者缩回以及钳臂11相对推杆40的打开或者合拢也可以不同步。例如，将钳臂11与延伸臂20连接于不同的驱动结构上，从而使得钳臂11能够与延伸臂20分开运动，以使得延伸臂20的伸长或者缩回以及钳臂11相对推杆40的打开或者合拢能够实现不同步。具体的，可以使得钳臂11的齿轮111与推杆40的齿条421进行啮合，从而通过推杆40的轴向移动实现钳臂11相对推杆40的开合。并且，设置另一推杆，并将延伸臂20与另一推杆进行连接，从而通过另一推杆驱动延伸臂20进行伸长或者缩回，即钳臂11与延伸臂20分别通过独立的推杆进行控制，从而实现延伸臂20的伸长或者缩回与钳臂11相对推杆40的打开或者合拢不同步。Please refer to FIG. 13 . In some embodiments of the present application, the extension arm 20 includes a fixed end 20a and a free end 20b opposite to each other. The fixed end 20a is rotatably fixed to the distal end of the push rod 40. In one embodiment of the present application, the fixed end 20a is rotatably fixed to the base 43 at the distal end of the push rod 40. The fixed end 20a of the extension arm 20 is located in the notch 411 on the base 43. In addition, there is a pin hole 114 on the fixed end 20a. The pin passes through the pin hole 114 and the two ends of the pin are fixed to the inner wall of the notch 411, thereby realizing the rotational fixation of the fixed end 20a and the base 43. When the push rod 40 is pushed axially, the push rod 40 drives the end of the extension arm 20 to exceed the free end 11a of the clamp arm 11. Specifically, when the push rod 40 moves axially toward the distal end, it can drive the end of the extension arm 20 to retract axially along the clamp arm 11; when the push rod 40 moves axially toward the proximal end, it can drive the end of the extension arm 20 to extend axially along the clamp arm 11. At the same time, in some embodiments of the present application, since the axial movement of the push rod 40 can drive the clamp arm 11 to open and close relative to the push rod 40, it is possible to achieve the opening and closing of the clamp arm 11 relative to the push rod 40 and the axial extension and retraction of the extension arm 20 along the clamp arm 11 by axially moving the push rod 40, thereby achieving the opening and closing control of the clamp arm 11 relative to the push rod 40 and the axial extension and retraction control of the extension arm 20 relative to the clamp arm 11 without adding additional surgical operation steps, thereby reducing the difficulty of the operation. It is understandable that in other embodiments of the present application, the extension or retraction of the extension arm 20 and the opening or closing of the clamp arm 11 relative to the push rod 40 can also be asynchronous. For example, the clamp arm 11 and the extension arm 20 are connected to different driving structures, so that the clamp arm 11 can move separately from the extension arm 20, so that the extension or retraction of the extension arm 20 and the opening or closing of the clamp arm 11 relative to the push rod 40 can be achieved asynchronously. Specifically, the gear 111 of the clamp arm 11 can be meshed with the rack 421 of the push rod 40, so that the opening and closing of the clamp arm 11 relative to the push rod 40 is achieved through the axial movement of the push rod 40. In addition, another push rod is provided, and the extension arm 20 is connected to the other push rod, so that the extension arm 20 is driven to extend or retract by the other push rod, that is, the clamp arm 11 and the extension arm 20 are controlled by independent push rods respectively, so that the extension or retraction of the extension arm 20 and the opening or closing of the clamp arm 11 relative to the push rod 40 are achieved asynchronously.
一些实施例中，瓣膜夹合器100还包括延伸臂钢套21，延伸臂20的固定端20a通过焊接或压接等方式固定于延伸臂钢套21上。延伸臂钢套21远离延伸臂20的一端位于基座43上的缺口433内。并且延伸臂钢套21远离延伸臂20的一端上具有销钉孔，缺口433的相对的两个侧壁上均具有固定孔434，销钉穿过销钉孔且销钉的两端固定于固定孔434中，从而实现延伸臂钢套21与基座43的旋转固定，进而实现延伸臂20的固定端20a与基座43旋转固定。In some embodiments, the valve clipper 100 further includes an extension arm steel sleeve 21, and the fixed end 20a of the extension arm 20 is fixed to the extension arm steel sleeve 21 by welding or crimping. The end of the extension arm steel sleeve 21 away from the extension arm 20 is located in the notch 433 on the base 43. In addition, a pin hole is provided on the end of the extension arm steel sleeve 21 away from the extension arm 20, and the two opposite side walls of the notch 433 are provided with fixing holes 434, and the pin passes through the pin hole and the two ends of the pin are fixed in the fixing holes 434, thereby realizing the rotational fixation of the extension arm steel sleeve 21 and the base 43, and then realizing the rotational fixation of the fixed end 20a of the extension arm 20 and the base 43.
本申请中，延伸臂20伸出钳臂11是指延伸臂20的末端伸出钳臂11的自由端11b，即延伸臂20的端部位于钳臂11的自由端11b远离固定端11a的一侧；延伸臂20的末端收入钳臂11是指延伸臂20的端部收缩至钳臂11的自由端11b与固定端11a之间。推杆40向近端方向进行轴向移动时，钳臂11相对推杆40打开，同时延伸臂20伸出钳臂11。当延伸臂20伸出钳臂11时，延伸臂20相当于延长了钳臂11的长度，当钳臂11相对推杆40张开以捕获瓣叶时，延长的钳臂11能够增加承托的瓣叶长度，使得瓣叶不容易从钳臂11处滑脱，从而使得瓣膜夹合器100对瓣叶的捕获更容易，方便夹持。并且，由于钳臂11的实际长度不变，因此，瓣膜夹合器100夹持瓣叶的长度实际上并不会发生改变，避免了瓣膜夹合器100的长度过长而可能产生的问题。优选的，每个钳臂11的内表面和/或外表面均设有至少一根延伸臂20。以使得每个钳臂11的长度均可以加长，从而使得每个钳臂11均能够容易的捕获瓣叶。本实施例中，延伸臂20的整体光滑，伸出钳臂11的一端通过激光点焊形成光滑的圆头，没有毛刺、棱边、棱角等缺陷，避免对瓣叶的损伤。In the present application, the extension arm 20 extending the clamp arm 11 means that the end of the extension arm 20 extends out of the free end 11b of the clamp arm 11, that is, the end of the extension arm 20 is located on the side of the free end 11b of the clamp arm 11 away from the fixed end 11a; the end of the extension arm 20 retracting into the clamp arm 11 means that the end of the extension arm 20 is retracted to between the free end 11b and the fixed end 11a of the clamp arm 11. When the push rod 40 moves axially in the proximal direction, the clamp arm 11 opens relative to the push rod 40, and the extension arm 20 extends out of the clamp arm 11. When the extension arm 20 extends out of the clamp arm 11, the extension arm 20 is equivalent to extending the length of the clamp arm 11. When the clamp arm 11 opens relative to the push rod 40 to capture the leaflet, the extended clamp arm 11 can increase the length of the supported leaflet, so that the leaflet is not easy to slip off the clamp arm 11, so that the valve clip 100 is easier to capture the leaflet and convenient to clamp. Furthermore, since the actual length of the clamp arm 11 remains unchanged, the length of the valve leaflet clamped by the valve clamp 100 does not actually change, thereby avoiding the problem that may arise from the excessive length of the valve clamp 100. Preferably, at least one extension arm 20 is provided on the inner surface and/or outer surface of each clamp arm 11. This allows the length of each clamp arm 11 to be lengthened, so that each clamp arm 11 can easily capture the valve leaflet. In this embodiment, the entire extension arm 20 is smooth, and one end extending out of the clamp arm 11 is formed into a smooth round head by laser spot welding, without defects such as burrs, edges, and corners, thereby avoiding damage to the valve leaflet.
本发明一些实施例中，延伸臂20包括延伸臂主体。延伸臂主体包括一根或者多根并排设置的支撑杆，以通过支撑杆直接承托瓣叶。支撑杆可以为实心或空心结构，也可以为单层或者多层复合结构。例如，支撑杆可以为一种材料形成的实心或者空心杆，也可以为多种不同材料的形成的内径大小不同的空心管套合得到。或者，支撑杆还可以由单根丝或者多根丝绕制而成。支撑杆的截面可以为规则的圆形或者椭圆形、月牙形、半圆形、多边形等形状，优选为圆形，易于加工同时又能避免支撑杆对瓣叶的伤害。进一步的，本实施例中，支撑杆为柔性和/或弹性的生物相容性材料制成，以适应瓣叶的解剖结构及瓣叶的活动幅度，且避免损伤瓣叶。例如可以选择金属材料、聚合物材料或者金属-聚合物复合材料制成。具体地，支撑杆由金属-高分子复合材料制成，本实施例中采用镍钛合金和PTFE制成。In some embodiments of the present invention, the extension arm 20 includes an extension arm body. The extension arm body includes one or more support rods arranged side by side to directly support the leaflets through the support rods. The support rod can be a solid or hollow structure, or a single-layer or multi-layer composite structure. For example, the support rod can be a solid or hollow rod formed of one material, or a hollow tube with different inner diameters formed of multiple different materials. Alternatively, the support rod can also be wound by a single wire or multiple wires. The cross-section of the support rod can be a regular circular or elliptical, crescent-shaped, semicircular, polygonal, etc., preferably a circular shape, which is easy to process and can avoid damage to the leaflets by the support rod. Further, in this embodiment, the support rod is made of a flexible and/or elastic biocompatible material to adapt to the anatomical structure of the leaflets and the range of motion of the leaflets, and to avoid damage to the leaflets. For example, a metal material, a polymer material or a metal-polymer composite material can be selected. Specifically, the support rod is made of a metal-polymer composite material, and in this embodiment, nickel-titanium alloy and PTFE are used.
进一步的，本发明的其它实施例中，延伸臂20包括由柔性材料制成的延伸臂主体，还包括支撑体，支撑体由刚性材料制成，例如不锈钢或钛合金等。支撑体设于延伸臂主体内部和/或外部，以增强延伸臂20的强度，使得延伸臂20具有一定的柔性以适应瓣叶的解剖结构及瓣叶的活动幅度的同时，具有一定刚性以对瓣叶进行有效的支撑。例如，一实施例中，延伸臂主体为由较柔软的材料制成柔性管，支撑体为硬度更高的材料制成的刚性杆，柔性管套设于刚性杆外以形成延伸臂20，此时，支撑体设于延伸臂主体外部。或者，本发明另一实施例中，延伸臂主体为柔性杆，支撑体为硬度更高的材料制成的刚性管，刚性管套设于柔性杆外以形成延伸臂20，此时，支撑体设于延伸臂主体的内部。或者，本发明另一实施例中，采用热缩管作为支撑体包裹在较柔软的延伸臂主体外表面，然后加热使热缩管收缩后包裹在延伸臂主体的外表面以提高支撑性，即延伸臂主体为柔性杆，刚性支撑体为热缩管，热缩管套于柔性杆外并加热收缩以同柔性杆固定，此时的支撑体设于延伸臂主体外部。或者，本发明另一实施例中，延伸臂主体由至少一根柔性丝(如，不锈钢丝)绕制而成，再将热塑性弹性体(例如，Pebax)包裹在延伸臂主体外部，然后加热使Pebax熔化后覆盖在延伸臂主体的外部，同时，部分的Pebax会通过柔性丝之间的缝隙渗入延伸臂主体内部，因此，此时的支撑体设于延伸臂主体内部和外部。Furthermore, in other embodiments of the present invention, the extension arm 20 includes an extension arm body made of a flexible material, and also includes a support body, which is made of a rigid material, such as stainless steel or titanium alloy. The support body is arranged inside and/or outside the extension arm body to enhance the strength of the extension arm 20, so that the extension arm 20 has a certain flexibility to adapt to the anatomical structure of the leaflet and the range of motion of the leaflet, while having a certain rigidity to effectively support the leaflet. For example, in one embodiment, the extension arm body is a flexible tube made of a softer material, the support body is a rigid rod made of a material with a higher hardness, and the flexible tube is sleeved outside the rigid rod to form the extension arm 20. In this case, the support body is arranged outside the extension arm body. Alternatively, in another embodiment of the present invention, the extension arm body is a flexible rod, the support body is a rigid tube made of a material with a higher hardness, and the rigid tube is sleeved outside the flexible rod to form the extension arm 20. In this case, the support body is arranged inside the extension arm body. Alternatively, in another embodiment of the present invention, a heat shrink tube is used as a support body to wrap around the outer surface of the relatively soft extension arm body, and then the heat shrink tube is heated to shrink and then wrapped around the outer surface of the extension arm body to improve the support, that is, the extension arm body is a flexible rod, and the rigid support body is a heat shrink tube, and the heat shrink tube is sleeved outside the flexible rod and heated to shrink to be fixed with the flexible rod, and the support body is arranged outside the extension arm body. Alternatively, in another embodiment of the present invention, the extension arm body is wound by at least one flexible wire (such as stainless steel wire), and then a thermoplastic elastomer (such as Pebax) is wrapped around the outside of the extension arm body, and then the Pebax is heated to melt and cover the outside of the extension arm body. At the same time, part of the Pebax will penetrate into the interior of the extension arm body through the gaps between the flexible wires. Therefore, the support body is arranged inside and outside the extension arm body.
进一步的，延伸臂20至少部分由不透射X射线材料制成。例如，延伸臂主体和/或支撑体由不透射X射线材料制成，从而使得延伸臂20自瓣膜夹合器100伸出后，与瓣叶接触，延伸臂20可以伴随瓣叶的活动幅度产生相应的摆动，此时操作者可以通过X射线快速准确地判断瓣叶的位置，如果位置合理，操作者即可驱动瓣膜夹合器100夹持瓣叶，从而缩短手术时间，提高手术成功率。不透射X射线材料选自不锈钢或镍钛合金。Further, the extension arm 20 is at least partially made of a non-X-ray-transmitting material. For example, the extension arm body and/or the support body are made of a non-X-ray-transmitting material, so that after the extension arm 20 extends from the valve clip 100 and contacts the valve leaflet, the extension arm 20 can swing accordingly with the movement amplitude of the valve leaflet. At this time, the operator can quickly and accurately determine the position of the valve leaflet through X-rays. If the position is reasonable, the operator can drive the valve clip 100 to clamp the valve leaflet, thereby shortening the operation time and improving the success rate of the operation. The non-X-ray-transmitting material is selected from stainless steel or nickel-titanium alloy.
请参阅图14a至图14e，图14a至图14e为本申请另一些实施例的延伸臂的结构示意图。这些实施例中，延伸臂20的自由端20b还设有承载部22。延伸臂20的末端超出钳臂11的自由端11b时，承载部22的宽度大于延伸臂20的直径，从而使得承载部22具有更大的承托面积，从而更好的承托瓣叶。其中，承载部22的宽度方向与钳臂11的宽度方向相同。承载部22可以为板状结构或者弹性件。如图14a所示，承载部22为板状结构，具体为平板状。如图14b至图14e所示，承载部22为弹性件，弹性件随延伸臂20收入于钳臂11时被压缩并处于压缩状态，弹性件随延伸臂20伸出钳臂11时，即延伸臂20的末端超出钳臂11的自由端时，弹性件不再受外部压迫从而舒展并处于舒展状态，舒展状态时的弹性件的面积大于压缩状态时的弹性件的面积，从而使得弹性件与瓣叶之间具有更大的接触面积，以更好地贴合瓣叶，提高延伸臂20对瓣叶的支撑性。优选的，本发明中，弹性件伸展后所在的面与钳臂11的第一表面112a之间平行，以使得弹性件伸展后与瓣叶之间有更大的接触面积，从而实现对瓣叶更好的支撑效果。具体的，第一平面112a与弹性件伸展后所在的面可以均为平面，也可以均为曲面。Please refer to Figures 14a to 14e, which are schematic diagrams of the structures of the extension arms of other embodiments of the present application. In these embodiments, the free end 20b of the extension arm 20 is also provided with a bearing portion 22. When the end of the extension arm 20 exceeds the free end 11b of the clamp arm 11, the width of the bearing portion 22 is greater than the diameter of the extension arm 20, so that the bearing portion 22 has a larger supporting area, thereby better supporting the leaflet. Among them, the width direction of the bearing portion 22 is the same as the width direction of the clamp arm 11. The bearing portion 22 can be a plate-like structure or an elastic member. As shown in Figure 14a, the bearing portion 22 is a plate-like structure, specifically a flat plate. As shown in Figures 14b to 14e, the bearing portion 22 is an elastic member. When the elastic member is retracted into the clamp arm 11 with the extension arm 20, it is compressed and in a compressed state. When the elastic member extends out of the clamp arm 11 with the extension arm 20, that is, when the end of the extension arm 20 exceeds the free end of the clamp arm 11, the elastic member is no longer compressed by the outside and is stretched and in a stretched state. The area of the elastic member in the stretched state is greater than the area of the elastic member in the compressed state, so that the elastic member has a larger contact area with the leaflet, so as to better fit the leaflet and improve the support of the extension arm 20 to the leaflet. Preferably, in the present invention, the surface where the elastic member is stretched is parallel to the first surface 112a of the clamp arm 11, so that the elastic member has a larger contact area with the leaflet after stretching, so as to achieve a better support effect on the leaflet. Specifically, the first plane 112a and the surface where the elastic member is stretched can be both planes or curved surfaces.
请参阅图14c，本发明的另一实施例中，弹性件为可变形的网笼。具体的，所述弹性件为具有一定的弹性以及张力的丝线编织形成的笼状结构。网笼收入于钳臂11内时，网笼挤压变形而处于压缩状态，并能够收入于钳臂11内。当网笼伸出钳臂11时，网笼舒展而处于舒展状态，舒展后的所述网笼的体积大于挤压时的网笼的体积，从而为延伸臂20上承托的瓣叶提供更稳定的支撑。本申请中，形成网笼的丝线可以为具有较好的生物相容性的金属丝或者具有一定弹性的高分子材料制成的丝线。本实施例中采用镍钛丝。进一步的，相较于如图14b所示实施例中的弹性件来说，本实施例的弹性件为立体的结构，能够有更加立体的显影效果，并能为延伸臂20上承托的瓣叶提供更稳定的支撑(如图16所示)。Please refer to FIG. 14c. In another embodiment of the present invention, the elastic member is a deformable mesh cage. Specifically, the elastic member is a cage-like structure formed by weaving silk threads with certain elasticity and tension. When the mesh cage is received in the clamp arm 11, the mesh cage is squeezed and deformed and is in a compressed state, and can be received in the clamp arm 11. When the mesh cage extends out of the clamp arm 11, the mesh cage is stretched and is in a stretched state. The volume of the stretched mesh cage is greater than the volume of the mesh cage when squeezed, thereby providing more stable support for the leaflets supported on the extension arm 20. In the present application, the silk thread forming the mesh cage can be a metal wire with good biocompatibility or a silk thread made of a polymer material with certain elasticity. Nickel-titanium wire is used in this embodiment. Further, compared with the elastic member in the embodiment shown in FIG. 14b, the elastic member in this embodiment is a three-dimensional structure, which can have a more three-dimensional imaging effect and can provide more stable support for the leaflets supported on the extension arm 20 (as shown in FIG. 16).
请一并参阅图14c及图15，本实施例中，网笼包括编织网221以及分别固定于编织网221的两端的封头222以及固定管223。具体的，镍钛丝形成一个筒状的编织网221，编织网221的一端固定于封头222内。即封头222将编织网221的一个开口端收拢并固定。编织网221的另一端收拢并固定于固定管223内。固定管223背离编织网221的一端连接至延伸臂20。封头222及固定管223均可以为金属材质或者高分子塑料材质制成。本实施例中，封头222为不锈钢材质制成。Please refer to Figure 14c and Figure 15 together. In this embodiment, the mesh cage includes a woven mesh 221 and a head 222 and a fixed tube 223 respectively fixed at both ends of the woven mesh 221. Specifically, the nickel-titanium wire forms a cylindrical woven mesh 221, and one end of the woven mesh 221 is fixed in the head 222. That is, the head 222 gathers and fixes an open end of the woven mesh 221. The other end of the woven mesh 221 is gathered and fixed in the fixed tube 223. The end of the fixed tube 223 facing away from the woven mesh 221 is connected to the extension arm 20. The head 222 and the fixed tube 223 can be made of metal or polymer plastic. In this embodiment, the head 222 is made of stainless steel.
本实施例中，网笼为中间为柱状，两头为锥形，且两头的锥形的锥角相同的结构。可以理解的是，本申请中，网笼也可以为其它的任何形状。例如，请参阅图14d及图14e，网笼可以为图14d所示的两头为锥角相同的锥形的纺锤形结构，也可以图14e所示的两头的锥角不同的结构。In this embodiment, the mesh cage is a structure with a columnar middle and two conical ends, and the cone angles of the two cones are the same. It is understood that in the present application, the mesh cage can also be any other shape. For example, referring to Figures 14d and 14e, the mesh cage can be a spindle-shaped structure with the same cone angle at both ends as shown in Figure 14d, or a structure with different cone angles at both ends as shown in Figure 14e.
请参阅图16及图17，图16所示为本申请的另一实施例的瓣膜夹合器100，图17为图16所示实施例的钳臂12的结构示意图。该实施例与图3所示实施例的差别在于：钳臂11的宽度大于夹持臂12的宽度。并且，钳臂11上设有容纳槽15，钳臂11与夹持臂12对合时，夹持臂12的凸齿121恰好位于钳臂11的容纳槽15内，使得钳臂11与夹持臂12对瓣膜的夹合效果更稳定。通过增大钳臂11的宽度，使得钳臂11的宽度大于夹持臂12的宽度，从而使得钳臂11与夹持臂12夹合瓣叶的夹合面积增加，夹合力更分散地施加在瓣叶上，减小对瓣膜的拉伤；并且，使得钳臂11的第一表面112a能够与夹持臂12的第三表面12d贴合，从而使得钳臂11贴合于推杆40时，瓣膜夹合器100的外径更小，便于瓣膜夹合器100的输送过程。本实施例中，增加钳臂11的宽度至6mm。Please refer to Figures 16 and 17. Figure 16 shows a valve clipper 100 according to another embodiment of the present application, and Figure 17 is a schematic diagram of the structure of the clamp arm 12 of the embodiment shown in Figure 16. The difference between this embodiment and the embodiment shown in Figure 3 is that the width of the clamp arm 11 is greater than the width of the clamp arm 12. In addition, the clamp arm 11 is provided with a receiving groove 15. When the clamp arm 11 and the clamp arm 12 are matched, the protruding teeth 121 of the clamp arm 12 are just located in the receiving groove 15 of the clamp arm 11, so that the clamp arm 11 and the clamp arm 12 have a more stable clamping effect on the valve. By increasing the width of the clamp arm 11, the width of the clamp arm 11 is larger than the width of the clamp arm 12, so that the clamping area of the valve leaflets clamped by the clamp arm 11 and the clamp arm 12 is increased, and the clamping force is applied to the valve leaflets more dispersedly, reducing the strain on the valve; and the first surface 112a of the clamp arm 11 can be attached to the third surface 12d of the clamp arm 12, so that when the clamp arm 11 is attached to the push rod 40, the outer diameter of the valve clip 100 is smaller, which facilitates the delivery process of the valve clip 100. In this embodiment, the width of the clamp arm 11 is increased to 6mm.
进一步的，一些实施例中，钳臂11上设有通孔115，且通孔115设于容纳槽15内，通过设置通孔115有助于内皮细胞的爬覆。可以理解的是，如图18所示，一些实施例中，钳臂11上也可以没有通孔115。Furthermore, in some embodiments, the forceps arm 11 is provided with a through hole 115, and the through hole 115 is provided in the receiving groove 15, and the through hole 115 is provided to facilitate the climbing of endothelial cells. It is understandable that, as shown in FIG. 18 , in some embodiments, the forceps arm 11 may also be provided with no through hole 115.
请参阅图19及图20，本发明还提供一种瓣膜夹合系统，瓣膜夹合系统包括推送装置及前述的瓣膜夹合器100，通过推送装置可将瓣膜夹合器100输送至二尖瓣处，并调整瓣膜夹合器100于二尖瓣的适宜位置。推送装置包括用于操作者握持的操作手柄及与操作手柄远端相连、且具有一定轴向长度的推送轴，推送轴近端与操作手柄连接，推送轴的远端与瓣膜夹合器100之间可拆卸连接。具体的，推送轴包括芯轴210、套设于芯轴210外的衬管220以及套设于衬管220外的外管230。操作手柄能够分别驱动芯轴210、衬管220以及外管230进行相对移动。Please refer to Figures 19 and 20. The present invention also provides a valve clamping system, which includes a pushing device and the aforementioned valve clamp 100. The valve clamp 100 can be delivered to the mitral valve by the pushing device, and the valve clamp 100 can be adjusted to a suitable position of the mitral valve. The pushing device includes an operating handle for the operator to hold and a pushing shaft connected to the distal end of the operating handle and having a certain axial length. The proximal end of the pushing shaft is connected to the operating handle, and the distal end of the pushing shaft is detachably connected to the valve clamp 100. Specifically, the pushing shaft includes a core shaft 210, a liner 220 sleeved outside the core shaft 210, and an outer tube 230 sleeved outside the liner 220. The operating handle can drive the core shaft 210, the liner 220, and the outer tube 230 to move relative to each other.
芯轴210的远端具有与推杆40的近端的螺纹孔412内的内螺纹相对应的外螺纹211。推送轴与瓣膜夹合器100连接时，芯轴210的远端与推杆40的近端进行螺纹连接，通过操作手柄驱动芯轴210移动，从而实现推杆40沿轴向的移动。The distal end of the mandrel 210 has an external thread 211 corresponding to the internal thread in the threaded hole 412 at the proximal end of the push rod 40. When the push shaft is connected to the valve clipper 100, the distal end of the mandrel 210 is threadedly connected to the proximal end of the push rod 40, and the mandrel 210 is driven to move by the operating handle, thereby realizing the axial movement of the push rod 40.
外管230的远端上设有T形弹片231，用于与基座连接管60上的T型槽63进行配合，以实现外管230与基座连接管60的连接与解锁。自然状态时，T型弹片的一端与外管230的远端连接，另一端向外管230的轴线所在位置倾斜。具体的，推送轴与瓣膜夹合器100连接时，芯轴210与推杆40螺纹连接，操作手柄驱动衬管220移动，以使得衬管220伸入基座连接管60内时，衬管220顶起外管230的T形弹片231，使得T形弹片231嵌入到基座连接管60的T形槽63内，此时基座连接管60与外管230处于连接状态；当操作所述操作手柄使得衬管220离开基座连接管60内，外管230的T型弹片231处于自然状态，即向内侧变形并从T形槽63脱离，使得基座连接管60与外套管230解开锁定。A T-shaped spring piece 231 is provided on the distal end of the outer tube 230, which is used to cooperate with the T-shaped slot 63 on the base connecting tube 60 to achieve the connection and unlocking of the outer tube 230 and the base connecting tube 60. In the natural state, one end of the T-shaped spring piece is connected to the distal end of the outer tube 230, and the other end is inclined toward the position where the axis of the outer tube 230 is located. Specifically, when the push shaft is connected to the valve clamp 100, the core shaft 210 is threadedly connected to the push rod 40, and the operating handle drives the liner 220 to move, so that when the liner 220 extends into the base connecting tube 60, the liner 220 pushes up the T-shaped spring piece 231 of the outer tube 230, so that the T-shaped spring piece 231 is embedded in the T-shaped slot 63 of the base connecting tube 60, and the base connecting tube 60 and the outer tube 230 are in a connected state; when the operating handle is operated to make the liner 220 leave the base connecting tube 60, the T-shaped spring piece 231 of the outer tube 230 is in a natural state, that is, it is deformed inward and disengaged from the T-shaped slot 63, so that the base connecting tube 60 and the outer tube 230 are unlocked.
以下以二尖瓣的瓣膜修复过程为例，说明本发明的瓣膜夹合系统的操作方法，主要包括以下步骤：The following takes the mitral valve repair process as an example to illustrate the operation method of the valve clipping system of the present invention, which mainly includes the following steps:
第一步：将推送轴与瓣膜夹合器100进行连接。旋转推送轴的芯轴210，使得芯轴210与推杆40固定。并向远端轴向移动衬管220，以将外管230的T形弹片231顶起以使得T形弹片231嵌入到基座连接管60的T形槽63内，使得基座连接管60与外管230处于连接状态。此时，基座连接管60上的弹片62的自由端位于推杆40的环槽411内，以使得钳臂11及夹持臂12均收拢于推杆40的表面。此时，推送轴与瓣膜夹合器100的连接状态如图21及图22所示。Step 1: Connect the push shaft to the valve clipper 100. Rotate the mandrel 210 of the push shaft to fix the mandrel 210 to the push rod 40. Move the liner 220 axially to the distal end to lift the T-shaped spring piece 231 of the outer tube 230 so that the T-shaped spring piece 231 is embedded in the T-shaped groove 63 of the base connecting tube 60, so that the base connecting tube 60 and the outer tube 230 are in a connected state. At this time, the free end of the spring piece 62 on the base connecting tube 60 is located in the annular groove 411 of the push rod 40, so that the clamp arm 11 and the clamp arm 12 are both retracted on the surface of the push rod 40. At this time, the connection state of the push shaft and the valve clipper 100 is shown in Figures 21 and 22.
第二步：通过推送轴将与其相连的瓣膜夹合器100从左心房推进，经过二尖瓣到达左心室。Step 2: Push the valve clipper 100 connected to the valve clipper 100 from the left atrium through the mitral valve to the left ventricle via the pushing shaft.
第三步：向远端轴向移动衬管220，使得衬管220顶起基座连接管60上的弹片62的自由端，使得弹片62的自由端脱离环槽411。此时，推杆40能够在基座连接管60内进行轴向移动，从而推动钳臂11相对推杆40的开合以及带动延伸臂20的伸长及收缩。Step 3: Move the liner 220 axially to the distal end, so that the liner 220 lifts the free end of the spring sheet 62 on the base connecting tube 60, so that the free end of the spring sheet 62 is separated from the annular groove 411. At this time, the push rod 40 can move axially in the base connecting tube 60, thereby pushing the clamp arm 11 to open and close relative to the push rod 40 and driving the extension arm 20 to extend and retract.
第四步：通过操作手柄向近端移动芯轴210，从而带动与芯轴210连接的推杆40向近端方向移动，以驱动钳臂11相对推杆40张开，同时使得延伸臂20自钳臂11中伸出。Step 4: Move the core shaft 210 proximally by operating the handle, thereby driving the push rod 40 connected to the core shaft 210 to move proximally to drive the clamp arm 11 to open relative to the push rod 40 and at the same time make the extension arm 20 extend from the clamp arm 11.
第五步：调整瓣膜夹合器100的方向，并通过X射线等设备观察每个钳臂11与前叶1a和后叶1b的相对位置，使得钳臂11垂直于二尖瓣的对合线。Step 5: Adjust the direction of the valve clip 100 and observe the relative position of each clamp arm 11 and the anterior leaflet 1a and the posterior leaflet 1b through X-ray equipment, so that the clamp arm 11 is perpendicular to the apposition line of the mitral valve.
第六步：向近端回撤整个调整瓣膜夹合器100，使钳臂11和延伸臂20在心室侧托住瓣叶。Step 6: withdraw the entire valve clamp 100 toward the proximal end so that the clamp arm 11 and the extension arm 20 hold the valve leaflet on the ventricular side.
第七步：释放夹持臂12，使得二尖瓣的前叶1a和后叶1b分别被夹持在一对钳臂11和夹持臂12之间，由此抓持瓣叶。Step 7: Release the clamping arm 12 so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are clamped between the pair of forceps arms 11 and the clamping arm 12, respectively, thereby grasping the valve leaflets.
第八步：向远端移动芯轴210，芯轴210带动推杆40向远端移动，从而驱动钳臂11收拢，并使得延伸臂20收入到限位件14内，即延伸臂20的末端回缩；Step 8: Move the mandrel 210 to the distal end, and the mandrel 210 drives the push rod 40 to move to the distal end, thereby driving the clamp arm 11 to close, and making the extension arm 20 retract into the limiter 14, that is, the end of the extension arm 20 retracts;
第九步：外管230固定不动，衬管220向近端回撤一定的行程，此时基座连接管60的弹片62的自由端卡入到推杆40的环槽411内，以保证钳臂11始终收拢。通过操作手柄控制芯轴210旋转，使得芯轴210与推杆40之间螺纹解锁。向近端回撤衬管220和芯轴210，直至外管230的T形弹片231与基座连接管60的T形卡槽63解锁分离。此时，瓣膜夹合器100与推送轴完全分离。将推送轴撤出患者体外，瓣膜夹合器100留置于患者体内，完成二尖瓣的瓣叶缘对缘修复。Step 9: The outer tube 230 is fixed, and the liner 220 is withdrawn to the proximal end for a certain stroke. At this time, the free end of the spring piece 62 of the base connecting tube 60 is inserted into the annular groove 411 of the push rod 40 to ensure that the clamp arm 11 is always closed. The core shaft 210 is controlled to rotate by the operating handle so that the threads between the core shaft 210 and the push rod 40 are unlocked. The liner 220 and the core shaft 210 are withdrawn to the proximal end until the T-shaped spring piece 231 of the outer tube 230 is unlocked and separated from the T-shaped slot 63 of the base connecting tube 60. At this time, the valve clip 100 is completely separated from the push shaft. The push shaft is withdrawn from the patient's body, and the valve clip 100 is left in the patient's body to complete the edge-to-edge repair of the mitral valve leaflet.
本发明的瓣膜夹合系统，能够实现在体外进行操作，以将瓣膜夹合器夹合瓣叶，减轻或避免“二尖瓣反流”的问题。并且，由于瓣膜夹合器能够容易的捕捉瓣叶，从而使得通过瓣膜夹合系统进行“二尖瓣反流”手术的难度大大降低，并降低手术时间。The valve clipping system of the present invention can be operated in vitro to clip the valve leaflets with the valve clipper, thereby alleviating or avoiding the problem of "mitral regurgitation". In addition, since the valve clipper can easily capture the valve leaflets, the difficulty of performing "mitral regurgitation" surgery with the valve clipping system is greatly reduced, and the operation time is reduced.
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以所述权利要求的保护范围为准。The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910632959.XACN112206017B (en) | 2019-07-12 | 2019-07-12 | Easy-to-clamp valve clamp and valve clamping system |
| PCT/CN2020/101374WO2021008461A1 (en) | 2019-07-12 | 2020-07-10 | Easily operable valve clamping device and valve clamping system |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910632959.XACN112206017B (en) | 2019-07-12 | 2019-07-12 | Easy-to-clamp valve clamp and valve clamping system |
| Publication Number | Publication Date |
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| CN112206017A CN112206017A (en) | 2021-01-12 |
| CN112206017Btrue CN112206017B (en) | 2024-11-01 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910632959.XAActiveCN112206017B (en) | 2019-07-12 | 2019-07-12 | Easy-to-clamp valve clamp and valve clamping system |
| Country | Link |
|---|---|
| CN (1) | CN112206017B (en) |
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