CN114762635A - Valve clamping device and valve clamping system with full fitting - Google Patents

Abstract

Translated fromChinese

本发明公开了一种贴合充分的瓣膜夹合装置和瓣膜夹合系统。该贴合充分的瓣膜夹合装置包括支撑部、调节部及夹合部。支撑部具有一定轴向长度，且包括相对设置的第一端和第二端；调节部包括相对设置的第一端和第二端、以及位于第一端和第二端之间的自扩展主体；调节部的第一端活动套设在支撑部的外侧，调节部的第二端套设在支撑部的外侧并与支撑部固定连接，调节部的第一端位于支撑部的第一端与调节部的第二端之间；夹合部设于支撑部的外侧并可相对于调节部展开或闭合。该贴合充分的瓣膜夹合装置能够增加瓣叶与调节部的贴合面积，使得瓣叶与调节部充分贴合，进而提高夹持力以牢靠地夹持住瓣叶。

The invention discloses a valve clamping device and valve clamping system with sufficient fit. The fully fitted valve clamping device includes a supporting part, an adjusting part and a clamping part. The support part has a certain axial length, and includes a first end and a second end arranged oppositely; the adjustment part includes a first end and a second end arranged oppositely, and a self-expanding body located between the first end and the second end The first end of the adjustment part is movably sleeved on the outside of the support part, the second end of the adjustment part is sleeved on the outside of the support part and is fixedly connected with the support part, and the first end of the adjustment part is located at the first end of the support part and the support part. between the second ends of the adjusting part; the clamping part is arranged on the outer side of the supporting part and can be unfolded or closed relative to the adjusting part. The fully fitted valve clamping device can increase the fitting area of the valve leaflet and the adjustment part, so that the valve leaflet and the adjustment part are fully fitted, thereby increasing the clamping force to firmly clamp the valve leaflet.

Description

Translated fromChinese

贴合充分的瓣膜夹合装置及瓣膜夹合系统Adequate fit valve clamping device and valve clamping system

技术领域technical field

本申请涉及介入式医疗器械技术领域，尤其涉及一种贴合充分的瓣膜夹合装置和瓣膜夹合系统。The present application relates to the technical field of interventional medical devices, and in particular, to a valve clamping device and a valve clamping system that fit well.

背景技术Background technique

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1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的乳头肌上。正常情况下，心脏左心室3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1的瓣叶或其相关结构发生器质性改变或功能性改变时，如腱索4部分断裂，二尖瓣1的前叶1a和后叶1b对合不良，由此，当心脏左心室3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 Figure 1, themitral valve 1 is a one-way valve located between theleft atrium 2 and theleft ventricle 3 of the heart. A normalhealthy mitral valve 1 can control the flow of blood from theleft atrium 2 to theleft ventricle 3, while preventing blood from flowing from theleft atrium 2 to theleft ventricle 3.Left ventricle 3 flows intoleft atrium 2. Themitral valve 1 includes a pair of leaflets, referred to as ananterior leaflet 1a and aposterior leaflet 1b. Theanterior lobe 1a and theposterior lobe 1b are fixed to the papillary muscle of theleft ventricle 3 through thechordae tendineae 4 . Under normal circumstances, when theleft ventricle 3 of the heart contracts, the edges of theanterior lobe 1a and theposterior lobe 1b are completely aligned, preventing blood from flowing from theleft ventricle 3 to theleft atrium 2. Please refer to Fig. 2, when the leaflets ofmitral valve 1 or their related structures change qualitatively or functionally, such as partial rupture ofchordae tendineae 4, theanterior leaflet 1a andposterior leaflet 1b ofmitral valve 1 are misaligned Therefore, when theleft ventricle 3 of the heart contracts, themitral valve 1 cannot be completely closed, resulting in the regurgitation of blood from theleft ventricle 3 to theleft atrium 2, thereby causing a series of pathophysiological changes, called "mitral valve regurgitation" ".

介入式二尖瓣夹合术是指通过向二尖瓣植入瓣膜夹合装置，使用一对可闭合的钳臂将前叶和后叶拉向彼此，减小或消除瓣叶间隙从而治疗二尖瓣反流。图3及图4示出了一种现有的瓣膜夹合装置，该瓣膜夹合装置90在两个钳臂91中增加了弹性网93，每侧的瓣叶L被分别夹持在一侧钳臂91和弹性网93的一侧之间，通过弹性网93的变形来适应瓣叶的间距，从而调节钳臂91对瓣叶L的牵拉程度。该弹性网93的一端931通过钢套等封头固定连接支撑部95的第一端951(第一端951指支撑部95靠近两钳臂91转动连接部位的一端)，弹性网93的另一端933为活动围绕支撑部95的自由端。在两钳臂91闭合的时候，弹性网93受到挤压而变形，由于封头97限制了弹性网93的一端931的轴向活动，弹性网93在轴向上会朝向其自由端933伸长，同时弹性网93被两钳臂91挤压的两侧会在径向上回缩，弹性网93的自由端933及其附近的部位受回缩部位的影响而逐渐朝向弹性网93的中轴线收拢，这就使得弹性网93的自由端933及其附近的部位与瓣叶L之间存在径向间隙X，即瓣叶L无法贴合弹性网93的自由端933及其附近的部位，瓣叶L与弹性网93的弹性贴合面积有限，相应地，弹性网93的自由端933及其附近的部位不能够为瓣叶L提供径向支撑力，有可能导致钳臂91和弹性网93对瓣叶L的夹持力不足以牢靠地夹持住瓣叶L，存在瓣叶L从钳臂91和弹性网93之间脱落的风险，影响瓣膜夹合装置的植入稳定性；同时，弹性网93的自由端933及其附近的部位与瓣叶L之间的径向间隙X允许自夹合间隙反流的血液透过，影响反流治疗效果。Interventional mitral valve clipping refers to the treatment of the mitral valve by implanting a valve clipping device into the mitral valve, using a pair of closable clamp arms to draw the anterior and posterior leaflets toward each other, reducing or eliminating the leaflet gap. cusp regurgitation. Figures 3 and 4 show an existing valve clamping device. Thevalve clamping device 90 addselastic nets 93 to the twoclamp arms 91, and the valve leaflets L on each side are respectively clamped on one side. Between theforceps arm 91 and one side of theelastic net 93 , the distance between the valve leaflets is adapted by the deformation of theelastic net 93 , so as to adjust the pulling degree of the valve leaflet L by theforceps arm 91 . Oneend 931 of theelastic net 93 is fixedly connected to thefirst end 951 of thesupport portion 95 through a head such as a steel sleeve (thefirst end 951 refers to the end of thesupport portion 95 that is close to the rotational connection portion of the two clamp arms 91 ), and the other end of theelastic net 93 933 is the free end of the movable surroundingsupport portion 95 . When the twoclamp arms 91 are closed, theelastic net 93 is squeezed and deformed. Since the head 97 restricts the axial movement of oneend 931 of theelastic net 93, theelastic net 93 will elongate toward itsfree end 933 in the axial direction. At the same time, the two sides of theelastic net 93 squeezed by the twoclamp arms 91 will retract in the radial direction, and thefree end 933 of theelastic net 93 and its adjacent parts are gradually retracted toward the central axis of theelastic net 93 under the influence of the retracted part. , which makes a radial gap X exist between thefree end 933 of theelastic mesh 93 and its vicinity and the leaflet L, that is, the leaflet L cannot fit thefree end 933 of theelastic mesh 93 and its vicinity, and the leaflet L cannot fit thefree end 933 of theelastic mesh 93 and its vicinity. The elastic bonding area between L and theelastic net 93 is limited. Accordingly, thefree end 933 of theelastic net 93 and its vicinity cannot provide radial support for the leaflet L, which may cause theforceps arm 91 and theelastic net 93 to align with each other. The clamping force of the valve leaflet L is not enough to firmly hold the valve leaflet L, and there is a risk of the valve leaflet L falling off between theforceps arm 91 and theelastic mesh 93, which affects the implantation stability of the valve clamping device; The radial gap X between thefree end 933 of themesh 93 and its vicinity and the valve leaflet L allows the blood backflowing from the clipping gap to pass through, which affects the effect of the backflow treatment.

发明内容SUMMARY OF THE INVENTION

为了解决上述技术问题或者至少部分地解决上述技术问题，本申请提供一种贴合充分的瓣膜夹合装置和瓣膜夹合系统。In order to solve the above technical problems or at least partially solve the above technical problems, the present application provides a valve clamping device and valve clamping system that fit well.

第一方面，本申请提供了一种贴合充分的瓣膜夹合装置，包括：In a first aspect, the present application provides a fully fitted valve clamping device, comprising:

支撑部，所述支撑部具有一定轴向长度，且包括相对设置的第一端和第二端；a support part, the support part has a certain axial length and includes a first end and a second end arranged oppositely;

调节部，所述调节部包括相对设置的第一端和第二端、以及位于所述第一端和所述第二端之间的自扩展主体；所述调节部的第一端活动套设在所述支撑部的外侧，所述调节部的第二端套设在所述支撑部的外侧并与所述支撑部固定连接，所述调节部的第一端位于所述支撑部的第一端与所述调节部的第二端之间；an adjustment part, the adjustment part includes a first end and a second end arranged oppositely, and a self-expanding body located between the first end and the second end; the first end of the adjustment part is movably sleeved On the outside of the support part, the second end of the adjustment part is sleeved on the outside of the support part and is fixedly connected with the support part, and the first end of the adjustment part is located at the first end of the support part between the end and the second end of the adjusting portion;

夹合部，所述夹合部设于所述支撑部的外侧并可相对于所述调节部展开或闭合。The clamping part is arranged on the outer side of the supporting part and can be unfolded or closed relative to the adjusting part.

第二方面，本申请提供了一种瓣膜夹合系统，包括上述贴合充分的瓣膜夹合装置、以及输送装置，其中，所述输送装置包括：具有一定轴向长度的推送鞘管及活动地穿装在所述推送鞘管中的芯轴，所述推送鞘管与所述支撑部之间可拆卸连接，所述芯轴用于驱动所述夹合部的展开和闭合。In a second aspect, the present application provides a valve clamping system, including the above-mentioned fully fitted valve clamping device, and a delivery device, wherein the delivery device includes: a pusher sheath having a certain axial length and a movable A mandrel inserted in the push sheath tube is detachably connected between the push sheath tube and the support part, and the mandrel is used to drive the expansion and closing of the clamping part.

本申请提供的瓣膜夹合装置和瓣膜夹合系统，将所述调节部的第二端套设在所述支撑部的外侧并与所述支撑部固定连接，将所述调节部的第一端活动套设在所述支撑部的外侧，以及将所述调节部的第一端设于所述支撑部的第一端与所述调节部的第二端之间，当所述夹合部相对所述调节部闭合以将瓣叶夹持在所述调节部的自扩展主体与所述夹合部之间时，所述调节部的第二端及其附近的部分自扩展主体的轴向活动受限，自扩展主体在轴向上会朝向调节部的第一端伸长，同时所述自扩展主体受所述夹合部的挤压会在径向上回缩，伴随着所述调节部的第一端朝向瓣叶的瓣缘延伸，自扩展主体朝着调节部的第一端逐渐朝向调节部的中轴线收拢，调节部第二端附近的部分自扩展主体与瓣叶之间能够紧密贴合而不存在径向间隙，相比于现有技术能够增加瓣叶与调节部的贴合面积，使得瓣叶与调节部充分贴合，相应地，所述调节部的第二端及其附近的部分自扩展主体能够为瓣叶提供径向支撑力，进而提高夹持力以牢靠地夹持住瓣叶，降低瓣叶从夹合部与调节部之间脱落的风险，提升瓣膜夹合装置的植入稳定性；同时，调节部第二端附近的部分自扩展主体与瓣叶之间的紧密贴合能够封堵自夹合间隙反流的血液，优化反流治疗效果。In the valve clamping device and valve clamping system provided by the present application, the second end of the adjusting portion is sleeved on the outside of the supporting portion and is fixedly connected with the supporting portion, and the first end of the adjusting portion is The movable sleeve is arranged on the outer side of the support part, and the first end of the adjustment part is arranged between the first end of the support part and the second end of the adjustment part, when the clamping parts are opposite to each other Axial movement of the second end of the adjustment portion and a portion of the self-expanding body near the adjustment portion when the adjustment portion is closed to clamp the leaflet between the self-expanding body of the adjustment portion and the clamping portion Limited, the self-expanding body will elongate toward the first end of the adjustment part in the axial direction, and at the same time the self-expanding body will be retracted in the radial direction by the compression of the clamping part, along with the adjustment part of the adjustment part. The first end extends toward the edge of the valve leaflet, the first end of the self-expanding main body is gradually retracted toward the central axis of the adjusting portion, and the self-expanding main body near the second end of the adjusting portion can be closely attached to the valve leaflet. There is no radial gap. Compared with the prior art, the contact area between the valve leaflet and the adjustment part can be increased, so that the valve leaflet and the adjustment part can fully fit. Correspondingly, the second end of the adjustment part and its vicinity Part of the self-expanding body can provide radial support force for the valve leaflet, thereby increasing the clamping force to firmly hold the valve leaflet, reducing the risk of the valve leaflet falling off between the clamping part and the adjusting part, and improving the valve clamping device At the same time, the close fit between the part of the self-expanding main body near the second end of the regulating part and the valve leaflets can block the blood refluxed from the self-clipping gap, and optimize the reflux treatment effect.

附图说明Description of drawings

此处的附图被并入说明书中并构成本说明书的一部分，附图示出了本发明的一些实施例，并与说明书一起用于解释本发明的原理。The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of the invention and together with the description serve to explain the principles of the invention.

为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，对于本领域普通技术人员而言，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. In other words, on the premise of no creative labor, other drawings can also be obtained from these drawings.

图1是二尖瓣正常状态时的示意图；Figure 1 is a schematic diagram of the normal state of the mitral valve;

图2是二尖瓣出现病变时的示意图；Figure 2 is a schematic diagram of the mitral valve when lesions occur;

图3是现有的一种瓣膜夹合装置的结构示意图；3 is a schematic structural diagram of an existing valve clamping device;

图4是图3所示的瓣膜夹合装置夹持瓣叶时的状态示意图；Fig. 4 is a state schematic diagram of the valve clamping device shown in Fig. 3 when the valve leaflet is clamped;

图5是本发明第一实施例的瓣膜夹合装置的结构示意图；5 is a schematic structural diagram of the valve clamping device according to the first embodiment of the present invention;

图6是图5中的调节部和支撑部组合后的结构示意图；FIG. 6 is a schematic structural diagram of the combination of the adjusting part and the supporting part in FIG. 5;

图7是图5中的调节部和固定件组合后的结构示意图；Fig. 7 is the structural schematic diagram after the adjustment part and the fixing member in Fig. 5 are combined;

图8a是图5中的调节部在一视角下的立体结构示意图；Fig. 8a is a schematic three-dimensional structure diagram of the adjusting portion in Fig. 5 from a viewing angle;

图8b是图5中的调节部在另一视角下的立体结构示意图；Fig. 8b is a schematic three-dimensional structure diagram of the adjusting portion in Fig. 5 from another viewing angle;

图9是图5中的瓣膜夹合装置夹持瓣叶时的状态示意图；Fig. 9 is the state schematic diagram when the valve clamping device in Fig. 5 clamps valve leaflet;

图10是图5中的夹合部和驱动部组合后的结构示意图；Figure 10 is a schematic structural diagram of the combination of the clamping part and the driving part in Figure 5;

图11是图5中的支撑部的结构示意图；Fig. 11 is the structural representation of the support part in Fig. 5;

图12是图5中的支撑部与基座配合的结构示意图；Figure 12 is a schematic structural diagram of the support part in Figure 5 in cooperation with the base;

图13是图5中瓣膜夹合装置的支撑部与输送装置配合的结构示意图；Figure 13 is a schematic structural diagram of the cooperation between the support part of the valve clamping device and the delivery device in Figure 5;

图14-图18是采用图5中的瓣膜夹合装置经左心房顺行接近并对二尖瓣实施缘对缘修复的过程示意图；14-18 are schematic diagrams of the process of using the valve clamping device in FIG. 5 to approach the left atrium antegradely and perform edge-to-edge repair of the mitral valve;

图19是本申请第二实施例的瓣膜夹合装置的结构示意图；19 is a schematic structural diagram of the valve clamping device according to the second embodiment of the present application;

图20是图19中的调节部和支撑部组合后的结构示意图；Figure 20 is a schematic structural diagram of the combination of the adjusting part and the supporting part in Figure 19;

图21是图19中的调节部和固定件组合后的结构示意图；Figure 21 is a schematic structural diagram of the combination of the adjusting part and the fixing part in Figure 19;

图22是本申请第三实施例的瓣膜夹合装置夹持瓣叶时的状态示意图；22 is a schematic diagram of the state when the valve clamping device according to the third embodiment of the present application clamps the valve leaflets;

图23是本申请第四实施例的瓣膜夹合装置的结构示意图；23 is a schematic structural diagram of the valve clamping device according to the fourth embodiment of the present application;

图24是图23中的支撑部、驱动部与夹合部组合后的结构示意图；Figure 24 is a schematic structural diagram of the combination of the support part, the drive part and the clamping part in Figure 23;

图25是图23中的瓣膜夹合装置夹持瓣叶时的状态示意图；Figure 25 is a schematic view of the state of the valve clamping device in Figure 23 when the valve leaflet is clamped;

图26是本申请第五实施例的瓣膜夹合装置的结构示意图；26 is a schematic structural diagram of the valve clamping device according to the fifth embodiment of the present application;

图27是本申请第六实施例的瓣膜夹合装置的结构示意图；27 is a schematic structural diagram of the valve clamping device according to the sixth embodiment of the present application;

图28是图27中的支撑部、驱动部与夹合部组合后的结构示意图；Figure 28 is a schematic structural diagram of the combination of the support part, the drive part and the clamping part in Figure 27;

图29是本申请第七实施例的瓣膜夹合装置的结构示意图；29 is a schematic structural diagram of the valve clamping device according to the seventh embodiment of the present application;

图30是本申请第八实施例的瓣膜夹合装置与输送装置配合的结构示意图；30 is a schematic structural diagram of the cooperation of the valve clamping device and the delivery device according to the eighth embodiment of the present application;

图31是图30所示的瓣膜夹合装置经心尖途径接近二尖瓣的示意图。Figure 31 is a schematic illustration of the valve clamping device shown in Figure 30 approaching the mitral valve via a transapical approach.

具体实施方式Detailed ways

下面将结合附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

在本发明的描述中，需要说明的是：In the description of the present invention, it should be noted that:

术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性；The orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or It is implied that the device or element referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting the invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and should not be construed to indicate or imply relative importance;

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。When an element is referred to as being "fixed to" or "disposed to" another element, it can be directly connected to the another element or indirectly connected to the another element through one or more connecting elements. 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.

还需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；将柱体、管体等一类物体的旋转中心轴的方向定义为轴向；周向为围绕柱体、管体等一类物体的轴线的方向(垂直于轴线，同时垂直于截面半径)；径向指沿直径或半径的方向。值得注意的是，无论“近端”、“远端”、“一端”、“另一端”、“第一端”、“第二端”、“初始端”、“末端”“两端”“自由端”、“上端”、“下端”等词语中所出现的“端”，并不仅限于端头、端点或端面，也包括自端头、端点、或端面在端头、端点、或端面所属元件上延伸一段轴向距离和/或径向距离的部位。上述定义只是为了表述方便，并不能理解为对本发明的限制。It should also be noted that in the field of interventional medical devices, the proximal end refers to the end that is closer to the operator, and the distal end refers to the end that is farther away from the operator. The direction of the shaft is defined as the axial direction; the circumferential direction is the direction around the axis of a cylinder, tube and other objects (perpendicular to the axis and perpendicular to the radius of the section); the radial direction refers to the direction along the diameter or radius. It is worth noting that regardless of "proximal end", "distal end", "one end", "other end", "first end", "second end", "initial end", "end", "both ends"" The "end" appearing in words such as "free end", "upper end", "lower end" is not limited to the end, end or end face, but also includes from the end, end point, or end face where the end, end point, or end face belongs A location on an element that extends an axial and/or radial distance. The above definitions are only for the convenience of expression, and should not be construed as limiting the present invention.

实施例一Example 1

请参阅图5至图9，本发明第一实施例提供的一种贴合充分的瓣膜夹合装置100包括：Please refer to FIG. 5 to FIG. 9 , avalve clamping device 100 provided by the first embodiment of the present invention with sufficient fit includes:

支撑部110，支撑部110具有一定轴向长度，且包括相对设置的第一端111和第二端115；asupport portion 110, thesupport portion 110 has a certain axial length and includes afirst end 111 and asecond end 115 arranged oppositely;

调节部120，调节部120包括相对设置的第一端121和第二端123、以及位于第一端121和第二端123之间的自扩展主体125；the adjustingpart 120, the adjustingpart 120 comprises afirst end 121 and asecond end 123 arranged oppositely, and a self-expandingbody 125 located between thefirst end 121 and thesecond end 123;

以及夹合部130，夹合部130设于调节部120的外侧并可相对于调节部120展开或闭合。And the clampingpart 130 , the clampingpart 130 is provided on the outer side of the adjustingpart 120 and can be unfolded or closed relative to the adjustingpart 120 .

该瓣膜夹合装置100的调节部120的第一端121活动套设在支撑部110的外侧，调节部120的第二端123套设在支撑部110的外侧并与支撑部110固定连接。调节部120的第一端121位于支撑部110的第一端111与调节部120的第二端123之间，或者说，调节部120的第一端121相较调节部120的第二端123更靠近支撑部110的第一端111。Thefirst end 121 of the adjustingportion 120 of thevalve clamping device 100 is movably sleeved outside thesupport portion 110 , and thesecond end 123 of the adjustingportion 120 is sleeved outside thesupport portion 110 and is fixedly connected to thesupport portion 110 . Thefirst end 121 of the adjustingpart 120 is located between thefirst end 111 of the supportingpart 110 and thesecond end 123 of the adjustingpart 120 , or in other words, thefirst end 121 of the adjustingpart 120 is compared with thesecond end 123 of the adjustingpart 120 closer to thefirst end 111 of thesupport portion 110 .

结合图5及图14-图18，该第一实施例的瓣膜夹合装置100在支撑部110的第二端115上设置与输送装置200可拆卸连接(如螺纹连接、卡扣连接等)的连接部(未标示)，输送装置200经导管将瓣膜夹合装置100推送至心脏内，则支撑部110的第二端115为其近端，支撑部110的第一端111为其远端，调节部120的第二端123为其近端，调节部120的第一端121为其远端。可以理解的是，在其他实施例中，瓣膜夹合装置可经心尖介入心脏，那么支撑部的第二端为其远端，支撑部的第一端为其近端，调节部的第二端为其远端，调节部的第一端为其近端。5 and FIGS. 14-18 , thevalve clamping device 100 of the first embodiment is provided with a detachable connection (such as screw connection, snap connection, etc.) to thedelivery device 200 on thesecond end 115 of thesupport portion 110 The connecting part (not marked), thedelivery device 200 pushes thevalve clamping device 100 into the heart through the catheter, thesecond end 115 of thesupport part 110 is the proximal end, thefirst end 111 of thesupport part 110 is the distal end, Thesecond end 123 of the adjustingportion 120 is its proximal end, and thefirst end 121 of the adjustingportion 120 is its distal end. It can be understood that, in other embodiments, the valve clamping device can be inserted into the heart through the apex, then the second end of the supporting portion is the distal end, the first end of the supporting portion is the proximal end, and the second end of the adjusting portion is the proximal end. being its distal end, and the first end of the adjustment portion being its proximal end.

请同时参阅图5-图9，瓣膜夹合装置100主要包括两种状态，一是展开状态，二是闭合状态。展开状态下，调节部120处于不受外力的自然状态，调节部120的自扩展主体125在自然状态下的直径自调节部120的第一端121向调节部120的第二端123逐渐增大，即，调节部120的整体外形近似呈倒锥体形，调节部120的第一端121大致构成倒锥体形的顶点，调节部120的第二端123附近的部位构成倒锥体形的锥底。该第一实施例中，夹合部130的一端转动连接于支撑部110的第一端111，从而夹合部130能够围绕调节部120并以其与支撑部110的第一端111的转动连接部位为中心展开或闭合，调节部120的第一端121与支撑部110的第一端111之间具有轴向间距，从而调节部120受到径向挤压时，调节部120的第一端121能够朝向支撑部110的第一端111做轴向移动，那么在夹合部130以其与支撑部110的第一端111的转动连接部位为中心并围绕调节部120闭合以夹持瓣叶1的过程中，调节部120受到夹合部130的挤压而发生径向回缩、轴向伸长的现象。可以理解的是，在其它实施例中，所述夹合部130的一端也可以转动连接于其它部件上，只要该部件靠近所述支撑部110的第一端111，使得夹合部130设于支撑部110的外侧并可相对于调节部120展开或闭合以夹持住瓣叶即可。Please refer to FIGS. 5-9 at the same time, thevalve clamping device 100 mainly includes two states, one is an unfolded state, and the other is a closed state. In the unfolded state, the adjustingportion 120 is in a natural state free from external force, and the diameter of the self-expandingbody 125 of the adjustingportion 120 in the natural state gradually increases from thefirst end 121 of the adjustingportion 120 to thesecond end 123 of the adjustingportion 120 That is, the overall shape of the regulatingportion 120 is approximately an inverted cone shape, thefirst end 121 of the regulatingportion 120 approximately constitutes the apex of the inverted cone shape, and the portion near thesecond end 123 of the regulatingportion 120 constitutes the bottom of the inverted cone shape. In the first embodiment, one end of the clampingportion 130 is rotatably connected to thefirst end 111 of the supportingportion 110 , so that the clampingportion 130 can surround the adjustingportion 120 and be rotatably connected with thefirst end 111 of the supportingportion 110 . The part is centrally expanded or closed, and there is an axial distance between thefirst end 121 of the adjustingpart 120 and thefirst end 111 of the supportingpart 110 , so that when the adjustingpart 120 is radially squeezed, thefirst end 121 of the adjustingpart 120 It can move axially toward thefirst end 111 of thesupport part 110, then the clampingpart 130 is centered on its rotational connection with thefirst end 111 of thesupport part 110 and closed around theadjustment part 120 to clamp theleaflet 1 During the process, the regulatingportion 120 is compressed by the clampingportion 130 to cause radial retraction and axial extension. It can be understood that, in other embodiments, one end of the clampingportion 130 can also be rotatably connected to other components, as long as the component is close to thefirst end 111 of the supportingportion 110, so that the clampingportion 130 is set at the The outer side of thesupport part 110 can be expanded or closed relative to theadjustment part 120 to hold the valve leaflet.

值得注意的是，在闭合状态下，由于调节部120的第二端123固定连接支撑部110，调节部120的第一端121活动套设在支撑部110上，调节部120的第二端123及其附近的部分自扩展主体125的轴向活动受限，自扩展主体125在轴向上会朝向调节部120的第一端121伸长，同时自扩展主体125受夹合部130的挤压会在径向上回缩，伴随着调节部120的第一端121朝向瓣叶1的瓣缘延伸，调节部120的整体外形可与夹合部130张开处的形状互补，并仍呈现出倒锥体形。调节部120的第二端123的附近的部分自扩展主体125位于倒锥体形的锥底，即自扩展主体125向调节部120的第一端121逐渐朝向调节部120的中轴线收拢，调节部120的第二端123附近的部分自扩展主体125与瓣叶1之间能够紧密贴合而不存在径向间隙，相比于现有技术能够增加瓣叶1与调节部120的贴合面积，提升瓣叶1与调节部120的弹性贴合性，使得瓣叶1与调节部120充分贴合。相应地，调节部120的第二端123及其附近的部分自扩展主体125能够为瓣叶1提供较大的径向支撑力，进而提高夹持力以牢靠地夹持住瓣叶1，降低瓣叶1从夹合部130与调节部120之间脱落的风险，提升瓣膜夹合装置100的植入稳定性；同时，调节部120的第二端123附近的部分自扩展主体125与瓣叶1之间的紧密贴合能够封堵自夹合间隙反流的血液，优化反流治疗效果。另外，调节部120可以根据夹合部130夹紧程度的不同而自适应调节自身形状，能够保证在任一夹紧程度下均可以充分贴合瓣叶。It is worth noting that in the closed state, since thesecond end 123 of the adjustingportion 120 is fixedly connected to the supportingportion 110 , thefirst end 121 of the adjustingportion 120 is movably sleeved on the supportingportion 110 , and thesecond end 123 of the adjustingportion 120 is movably sleeved on the supportingportion 110 . The axial movement of the self-expandingmain body 125 and its vicinity is limited, the self-expandingmain body 125 will elongate toward thefirst end 121 of the adjustingpart 120 in the axial direction, and at the same time, the self-expandingmain body 125 is squeezed by the clampingpart 130 Will retract in the radial direction, with thefirst end 121 of the adjustingportion 120 extending toward the valve edge of theleaflet 1, the overall shape of the adjustingportion 120 may complement the shape of the opening of the clampingportion 130, and still present an inverted shape. Conical shape. The part near thesecond end 123 of the adjustingpart 120 is located at the bottom of the inverted cone from the expandingbody 125 , that is, from the expandingbody 125 to thefirst end 121 of the adjustingpart 120 , it gradually shrinks toward the central axis of the adjustingpart 120 . Part of the self-expandingbody 125 near thesecond end 123 of the 120 can be closely fitted with thevalve leaflet 1 without a radial gap, which can increase the fitting area of thevalve leaflet 1 and theadjustment portion 120 compared to the prior art, The elastic fit between thevalve leaflet 1 and theadjustment part 120 is improved, so that thevalve leaflet 1 and theadjustment part 120 fully fit. Correspondingly, thesecond end 123 of the adjustingportion 120 and the self-expandingmain body 125 in the vicinity thereof can provide a greater radial support force for thevalve leaflet 1, thereby increasing the clamping force to firmly hold thevalve leaflet 1, reducing the The risk of thevalve leaflet 1 falling off between the clampingpart 130 and theadjustment part 120 improves the implantation stability of thevalve clamping device 100; at the same time, the part of the self-expandingbody 125 near thesecond end 123 of theadjustment part 120 and the valve leaflet The tight fit between 1 can block the blood refluxed from the self-clamping gap and optimize the effect of reflux treatment. In addition, the adjustingportion 120 can adjust its own shape adaptively according to the different clamping degrees of the clampingportion 130, which can ensure that the valve leaflet can be fully fitted under any clamping degree.

可以理解的是，在闭合状态下，调节部120的第一端121相较现有技术能够朝瓣缘延伸而更加接近瓣缘位置，进一步增加了瓣叶1与调节部120的贴合面积，进一步提升了瓣叶1与调节部120的弹性贴合性。It can be understood that, in the closed state, thefirst end 121 of theadjustment portion 120 can extend toward the valve edge and be closer to the valve edge than the prior art, which further increases the abutment area between thevalve leaflet 1 and theadjustment portion 120 . The elastic fit between thevalve leaflet 1 and theadjustment portion 120 is further improved.

此外，由于调节部120的第一端121活动套设在支撑部110上，调节部120具有较强的轴向变形能力，当该瓣膜夹合装置100被径向压缩到输送鞘中进行体内输送时，较易于被压缩入鞘。In addition, since thefirst end 121 of the adjustingportion 120 is movably sleeved on the supportingportion 110, the adjustingportion 120 has strong axial deformation ability, and when thevalve clamping device 100 is radially compressed into the delivery sheath for in vivo delivery , it is easier to be compressed into the sheath.

具体的，请参阅图5及图10-图13，支撑部110可以是两端面轴向贯通的圆管体、方柱管体或扁圆管体等。本实施例采用圆管体，如前所述，该圆管体的远端为第一端111，近端为第二端115。支撑部110的第二端115在闭合状态下和展开状态下均可被调节部120的第二端123的附近的部分自扩展主体125包围并遮蔽，从而不会外露出调节部120，防止该第二端115与瓣叶直接接触，避免该第二端115伴随着瓣叶的长期搏动而磨损瓣叶，提高了植入安全性。Specifically, please refer to FIG. 5 and FIGS. 10-13 , thesupport portion 110 may be a circular tube body, a square column tube body, or an oblate tube body, etc., whose both end faces are axially penetrated. This embodiment adopts a round tube body. As mentioned above, the distal end of the round tube body is thefirst end 111 and the proximal end is thesecond end 115 . Thesecond end 115 of thesupport part 110 can be surrounded and shielded by the self-expandingbody 125 near thesecond end 123 of the adjustingpart 120 in both the closed state and the unfolded state, so that the adjustingpart 120 is not exposed, preventing the Thesecond end 115 is in direct contact with the valve leaflet, which prevents thesecond end 115 from wearing the valve leaflet along with the long-term pulsation of the valve leaflet, thereby improving the safety of implantation.

支撑部110还设有轴向通孔状的穿设通道113，以与驱动部140和输送装置200联动配合。支撑部110的圆管体的管壁上设有至少两个卡位114，用于与输送装置200进行可拆卸连接。例如，输送装置200上设置卡台221，卡台221卡入卡位114后，输送装置200与支撑部110卡合连接，可进行瓣膜夹合装置100的输送，当卡台221脱离卡位114后，输送装置200与瓣膜夹合装置100分离。应当知晓，此处的支撑部110结构仅用作举例，并不是对本申请的限制，本领域的普通技术人员基于本申请的教导，采用的其他支撑部110的结构，均在本申请的保护范围内。Thesupport portion 110 is further provided with an axial through-hole-shaped through-passage 113 to cooperate with the drivingportion 140 and the conveyingdevice 200 . At least two clampingpositions 114 are provided on the pipe wall of the circular pipe body of thesupport portion 110 for detachable connection with the conveyingdevice 200 . For example, thedelivery device 200 is provided with a chucking table 221 , after the chucking table 221 is locked into thechucking position 114 , thedelivery device 200 is engaged with thesupport portion 110 , and thevalve clamping device 100 can be transported. When the chucking table 221 is released from thechucking position 114 Thereafter, thedelivery device 200 is separated from thevalve clamping device 100 . It should be known that the structure of thesupport portion 110 here is only used as an example, not a limitation of the present application. Those of ordinary skill in the art, based on the teachings of the present application, adopt other structures of thesupport portion 110, which are all within the protection scope of the present application. Inside.

请参阅图5-图9，调节部120的自扩展主体125为网状结构，优选为由具有形状记忆功能的丝材编织或者管材切割而成的网状结构，例如镍铁合金丝等超弹性材料。在同样的夹合部130闭合程度下，调节部120可适应不同瓣叶之间的间距而发生自适应变形，从而调节瓣膜夹合装置100对瓣叶的牵拉程度。调节部120具有中空容纳腔体(未标示)，支撑部110位于第二端115与第一端111之间的部分设于该中空容纳腔体内。Referring to FIGS. 5-9 , the self-expandingbody 125 of the adjustingportion 120 is a mesh structure, preferably a mesh structure made of a wire braided or cut from a pipe with a shape memory function, such as a superelastic material such as nickel-iron alloy wire . Under the same closing degree of the clampingpart 130 , the adjustingpart 120 can adapt to the spacing between different valve leaflets and undergo self-adaptive deformation, so as to adjust the pulling degree of the valve leaflet by thevalve clamping device 100 . The adjustingportion 120 has a hollow accommodating cavity (not shown), and the portion of the supportingportion 110 between thesecond end 115 and thefirst end 111 is disposed in the hollow accommodating cavity.

自扩展主体125包括依次连接的第一区段124、第二区段126及第三区段128。第一区段124自调节部120的第二端123朝向支撑部110的第二端115延伸，且该第一区段124相对第二区段126形成一类似于碗状的凹陷区122(如图7及图8a所示)，第一区段124围绕在支撑部110的第二端115的外侧，或者说支撑部110的第二端115位于所述凹陷区122内，支撑部110的第二端115在瓣膜夹合装置100的闭合状态下和展开状态下均可被自扩展主体125的第一区段124包围并遮蔽，从而不会外露出调节部120。第二区段126自第一区段124继续径向向外延伸。第三区段128自第二区段126朝向支撑部110的第一端111同时径向向内延伸至调节部12的第一端121截止。该第一实施例中，凹陷区122的末端(将第一区段124靠近调节部120的第二端123的一端定义为凹陷区122的末端)朝向支撑部110的第一端111延伸至调节部120的第二端123。The self-expandingbody 125 includes afirst segment 124 , asecond segment 126 and athird segment 128 which are connected in sequence. Thefirst section 124 extends from thesecond end 123 of the adjustingportion 120 toward thesecond end 115 of the supportingportion 110 , and thefirst section 124 forms a bowl-shapedconcave area 122 relative to the second section 126 (eg, 7 and 8a), thefirst section 124 surrounds the outer side of thesecond end 115 of thesupport portion 110, or thesecond end 115 of thesupport portion 110 is located in the recessedarea 122. Both ends 115 can be surrounded and shielded by thefirst section 124 of the self-expandingbody 125 in both the closed state and the expanded state of thevalve clamping device 100 , so that the adjustingportion 120 is not exposed. Thesecond section 126 continues to extend radially outward from thefirst section 124 . Thethird section 128 extends radially inwardly from thesecond section 126 toward thefirst end 111 of thesupport portion 110 and ends at thefirst end 121 of the adjusting portion 12 . In the first embodiment, the end of the concave area 122 (the end of thefirst segment 124 close to thesecond end 123 of the adjustingpart 120 is defined as the end of the concave area 122 ) extends toward thefirst end 111 of thesupport part 110 to adjust thesecond end 123 of theportion 120 .

制作该调节部120时，首先准备一两端开放的编织网管，将编织网管的一端套设在一衬棒上，然后将一成型套套设在该编织网管的一端外，形成调节件120的第二端123；接着向外同时向下拉动编织网管的另一端，使得该编织网管外翻至成型模具上；然后进行热定型处理，形成如图8a至图8b所示的整体外形近似呈倒锥体形的调节部120，且该编织网管的另一端于该编织网管的一端的下方形成调节件120的具有开口的第一端121，取下成型套及成型模具，即得到调节部120。When making theadjustment part 120, first prepare a braided mesh tube with both ends open, and sleeve one end of the braided mesh tube on a lining rod, and then sleeve a molding sleeve on one end of the braided mesh tube to form the first part of theadjustment member 120. Two ends 123; then pull the other end of the braided mesh tube outwards and downwards at the same time, so that the braided mesh tube is everted onto the forming die; then heat-setting treatment is performed to form the overall shape as shown in Figures 8a to 8b, which is approximately an inverted cone The body-shaped adjustingpart 120 is formed, and the other end of the braided mesh tube forms thefirst end 121 with an opening of the adjustingmember 120 below one end of the braided mesh tube.

调节部120与支撑部110组装时，将支撑部110的第二端115与第一端111之间的部分穿设于调节部120的中空容纳腔体内，调节部120的第二端123通过固定件80与支撑部110固定连接，固定件80可以是钢套，调节部120的第二端123穿装于钢套与支撑部110的外表面之间，再通过激光焊接钢套与支撑部110实现调节部120的第二端123与支撑部110的固定连接。可以理解的是，在其他实施例中，也可以不设置固定件80，而直接通过焊接方式将调节部120的第二端123固定连接至支撑部110上。本实施例中，调节部120的第二端123朝向支撑部110的第一端111穿装入固定件80，若以图6中调节部120的第二端123所在的方位为上、调节部120的第一端121所在的方位为下，即调节部120的第二端123从上向下穿装入固定件80。调节部120的第一端121所具有的开口的直径可等于或略大于支撑部110的直径，以活动套设在支撑部110上，从而调节部120的第一端121能够沿支撑部110的轴向顺畅滑动。另，由于调节部120的第二端123与支撑部110固定相连，而调节部120的第一端121活动套设在支撑部110上，整个瓣膜夹合装置100的重心始终位于支撑部110的轴向，因此自中心性较好，不易倾斜。When the adjustingpart 120 is assembled with the supportingpart 110 , the part between thesecond end 115 and thefirst end 111 of the supportingpart 110 is passed through the hollow receiving cavity of the adjustingpart 120 , and thesecond end 123 of the adjustingpart 120 is fixed by The fixingmember 80 is fixedly connected with the supportingportion 110. The fixingmember 80 can be a steel sleeve. Thesecond end 123 of the adjustingportion 120 is inserted between the steel sleeve and the outer surface of the supportingportion 110, and then the steel sleeve and the supportingportion 110 are welded by laser. The fixed connection between thesecond end 123 of the adjustingpart 120 and the supportingpart 110 is realized. It can be understood that, in other embodiments, the fixingmember 80 may not be provided, and thesecond end 123 of the adjustingportion 120 may be fixedly connected to the supportingportion 110 directly by welding. In this embodiment, thesecond end 123 of the adjustingportion 120 is inserted into the fixingmember 80 toward thefirst end 111 of the supportingportion 110 . If the orientation of thesecond end 123 of the adjustingportion 120 in FIG. 6 is taken as the upper, adjusting portion The orientation of thefirst end 121 of the 120 is downward, that is, thesecond end 123 of the adjustingportion 120 is inserted into the fixingmember 80 from top to bottom. The diameter of the opening of thefirst end 121 of the adjustingportion 120 may be equal to or slightly larger than the diameter of the supportingportion 110 , so as to be movably sleeved on the supportingportion 110 , so that thefirst end 121 of the adjustingportion 120 can follow the direction of the supportingportion 110 . Axial slides smoothly. In addition, since thesecond end 123 of the adjustingportion 120 is fixedly connected to the supportingportion 110 , and thefirst end 121 of the adjustingportion 120 is movably sleeved on the supportingportion 110 , the center of gravity of the entirevalve clamping device 100 is always located at the center of the supportingportion 110 . Axial, so the self-centering is good, and it is not easy to tilt.

更为具体的，在瓣膜夹合装置100自展开状态至闭合状态的变化过程中，自扩展主体125的第二区段126的径向尺寸(图6中以D标示)的范围优选为4mm-15mm，更优选5mm-10mm，调节部120的第一端121的径向尺寸的范围为1mm-5mm，更优选1.2mm-3mm，以使得调节部120整体呈现出的倒锥体形被压缩后既能够适应不同瓣叶之间的间距，又能够与瓣叶有尽可能大的贴合面积。More specifically, in the process of changing thevalve clamping device 100 from the deployed state to the closed state, the radial dimension of thesecond section 126 of the self-expanding body 125 (marked with D in FIG. 6 ) is preferably in the range of 4 mm- 15mm, more preferably 5mm-10mm, the radial dimension of thefirst end 121 of the adjustingpart 120 is in the range of 1mm-5mm, more preferably 1.2mm-3mm, so that the inverse cone shape presented by the adjustingpart 120 as a whole is compressed. It can adapt to the spacing between different leaflets, and can have as large a fitting area as possible with the leaflets.

结合图5、图6与图9，在瓣膜夹合装置100的闭合状态下，即瓣叶1被夹持在调节部120与夹合部130之间时，由于调节部120的第二端123固定连接支撑部110，调节部120的第一端121活动套设在支撑部110上，调节部120的第二端123、自扩展主体125的第一区段124及第二区段126的轴向活动受限，调节部120在轴向上会朝向其第一端121伸长，同时自扩展主体125受夹合部130的挤压会在径向上回缩，但第一区段124会抵抗第二区段126的向内变形，第二区段126又会将这种抵抗作用传递至与其相连的第三区段128的相应部分上，伴随着调节部120的第一端121朝向瓣叶1的瓣缘延伸，调节部120的整体外形呈现出与夹合部130张开处的形状互补的倒锥体形，第二区段126位于倒锥体形的锥底，第三区段128自第二区段126向第一端121逐渐朝向调节部120的中轴线收拢，自扩展主体125的第三区段128的整段均能与瓣叶1之间紧密贴合而不存在径向间隙，瓣叶1与调节部120的弹性贴合性得以提升，使得瓣叶1与调节部120能够充分贴合。相应地，调节部120能够为瓣叶1提供较大的径向支撑力，进而提高夹持力以牢靠地夹持住瓣叶1。如图9所示，自扩展主体125的第二区段126不低于夹合部130闭合时的自由端的端面，以使得夹合部130与调节部120之间所夹持的瓣叶1的长度基本与夹合部130等长。5, 6 and 9, in the closed state of the valve clamping device 100, that is, when the valve leaflet 1 is clamped between the adjustment part 120 and the clamping part 130, the second end 123 of the adjustment part 120 The supporting portion 110 is fixedly connected, the first end 121 of the adjusting portion 120 is movably sleeved on the supporting portion 110 , the second end 123 of the adjusting portion 120 , the shafts of the first section 124 and the second section 126 of the self-expanding body 125 When the movement is limited, the adjusting portion 120 will be elongated toward its first end 121 in the axial direction, while the self-expanding body 125 will be radially retracted by the clamping portion 130, but the first section 124 will resist Inward deformation of the second section 126, which in turn transmits this resistance to the corresponding portion of the third section 128 to which it is connected, with the first end 121 of the adjustment portion 120 facing the leaflet The valve edge of 1 extends, the overall shape of the adjustment part 120 presents an inverted cone shape complementary to the shape of the opening of the clamping part 130, the second section 126 is located at the cone bottom of the inverted cone shape, and the third section 128 starts from the third section 128. Thesecond section 126 gradually converges toward the central axis of the adjustingportion 120 toward thefirst end 121 , and the entire section of thethird section 128 of the self-expandingbody 125 can fit closely with thevalve leaflet 1 without radial gaps. The elastic fit between thevalve leaflet 1 and theadjustment part 120 is improved, so that thevalve leaflet 1 and theadjustment part 120 can fully fit. Correspondingly, the adjustingportion 120 can provide a larger radial support force for thevalve leaflet 1 , thereby increasing the clamping force to firmly hold thevalve leaflet 1 . As shown in FIG. 9 , thesecond section 126 of the self-expandingmain body 125 is not lower than the end surface of the free end of the clampingpart 130 when the clampingpart 130 is closed, so that thevalve leaflet 1 clamped between the clampingpart 130 and the adjustingpart 120 is not lower than the end surface of the free end. The length is substantially equal to that of the clampingportion 130 .

可以理解的是，在其他实施例中，网状结构的调节部120外部和/或内部可覆盖具有生物相容性的薄膜，一方面该薄膜可以作为阻流膜来封堵自夹合间隙反流的血液，提高反流治疗效果，并防止血液进入调节部120中形成血栓，另一方面该薄膜可以使得瓣膜夹合装置100具有更强的生物相容性。该薄膜的材质可以但不限于为PTFE、EPTFE、聚酯、硅树脂等具有生物相容性的聚合物。It can be understood that, in other embodiments, the outside and/or inside of the adjustingportion 120 of the mesh structure can be covered with a biocompatible film. The flow of blood can improve the effect of regurgitation treatment, and prevent blood from entering the regulatingpart 120 to form thrombus. On the other hand, the membrane can make thevalve clamping device 100 have stronger biocompatibility. The material of the film can be, but not limited to, PTFE, EPTFE, polyester, silicone resin and other biocompatible polymers.

当然，调节部120并不仅限于为网状结构，还可以是其它具有弹性可自扩展的中空结构，例如，可以是致密结构的硅胶体或多孔结构的海绵体，致密结构或多孔结构的调节部的第二端固定套设于支撑部110上，第一端轴向活动套设在支撑部110上，同样可以在第二端与第一端之间设置相似的第一区段、第二区段及第三区段，也可以基于同样的作用原理来使得瓣叶与调节部充分贴合。Of course, theadjustment part 120 is not limited to a mesh structure, but can also be other elastic and self-expandable hollow structures, for example, it can be a dense structure of silica gel or a porous structure of sponge, and the dense structure or porous structure of the adjustment part The second end is fixedly sleeved on thesupport part 110, and the first end is axially movably sleeved on thesupport part 110. Similarly, a similar first section and second area can be set between the second end and the first end. The segment and the third segment can also be based on the same working principle to make the valve leaflet and the adjustment part fully fit.

请参阅图5、及图9-图13，夹合部130包括至少两个钳臂131，一般可以包括至少一组钳臂131，每一组钳臂131包括相对于调节部120对称设置的两个钳臂131。本实施例中的夹合部130包括一组钳臂131，应当知晓，此处仅用作举例，本领域的普通技术人员可以根据需要选择合适的钳臂131数量，例如两组或更多组钳臂。可以理解的是，还可以根据需要在每组中设置三个或更多个钳臂131，例如，可以通过三个可相对开合的钳臂131来同时夹合三尖瓣的三片瓣叶，从而治疗三尖瓣反流；或者通过一对钳臂131来夹合三尖瓣的其中两片瓣叶，也可达到减轻或治疗三尖瓣反流的目的。Please refer to FIG. 5 , and FIGS. 9 to 13 , the clampingportion 130 includes at least two clamparms 131 , and generally may include at least one set ofclamp arms 131 , and each set ofclamp arms 131 includes twoclamp arms 131 symmetrically arranged relative to the adjustingportion 120 . Aclamp arm 131. The clampingportion 130 in this embodiment includes a set ofclamp arms 131. It should be understood that this is only used as an example, and those skilled in the art can select an appropriate number ofclamp arms 131 as required, such as two or more sets. Clamp Arm. It can be understood that three ormore forceps arms 131 can also be arranged in each group as required, for example, three leaflets of the tricuspid valve can be simultaneously clamped by three relatively openable andclosable forceps arms 131 , thereby treating tricuspid regurgitation; or clamping two of the leaflets of the tricuspid valve through a pair ofclamp arms 131, the purpose of reducing or treating tricuspid regurgitation can also be achieved.

本实施例中，瓣膜夹合装置100还包括驱动部140，驱动部140与夹合部130连接，以驱动夹合部130相对于调节部120展开或闭合。具体地，驱动部140分别与每个钳臂131连接，例如驱动部140分别与一组钳臂131中的两个钳臂131连接，以驱动每个钳臂131围绕调节部120转动，从而使得钳臂131靠近或远离调节部120。输送状态下，驱动部140驱动钳臂131围绕调节部120闭合，从而减少瓣膜夹合装置100的外径，利于输送；瓣膜夹合装置100在心脏内展开后，驱动部140驱动钳臂131将瓣叶夹持在钳臂131与调节部120之间，实现瓣叶夹持。In this embodiment, thevalve clamping device 100 further includes a drivingpart 140 , and the drivingpart 140 is connected with the clampingpart 130 to drive the clampingpart 130 to unfold or close relative to the regulatingpart 120 . Specifically, the drivingpart 140 is respectively connected with eachclamp arm 131, for example, the drivingpart 140 is respectively connected with twoclamp arms 131 in a group ofclamp arms 131, so as to drive eachclamp arm 131 to rotate around the adjustingpart 120, so that the Theclamp arm 131 is close to or away from the adjustingpart 120 . In the delivery state, the drivingpart 140 drives theclamp arm 131 to close around the adjustingpart 120, thereby reducing the outer diameter of thevalve clamping device 100, which is convenient for delivery; after thevalve clamping device 100 is deployed in the heart, the drivingpart 140 drives theclamping arm 131 to close thevalve clamping device 100. The valve leaflet is clamped between theforceps arm 131 and the adjustingportion 120 to realize the valve leaflet clamping.

在本实施例的一优选实施方式中，瓣膜夹合装置100还包括抓持部，一般可以包括至少一组抓持臂151，每一组抓持臂151包括相对于调节部120对称设置的两个抓持臂151。抓持部(例如抓持臂151)设于夹合部130(例如钳臂131)与调节部120之间并可相对调节部120展开或闭合，抓持部至少部分容置于夹合部130的内表面。当然，还可以根据需要在每组中设置三个或更多个抓持臂151，从而与钳臂131配合实现瓣叶捕捉功能。In a preferred implementation of this embodiment, thevalve clamping device 100 further includes a gripping portion, generally, at least one set of grippingarms 151 , and each set of grippingarms 151 includes two sets of grippingarms 151 symmetrically arranged relative to the adjustingportion 120 . Agripping arm 151. The gripping portion (eg, gripping arm 151 ) is disposed between the clamping portion 130 (eg, the pliers arm 131 ) and the adjustingportion 120 and can be unfolded or closed relative to the adjustingportion 120 , and the gripping portion is at least partially accommodated in thegripping portion 130 of the inner surface. Of course, three or moregrasping arms 151 may also be provided in each group as required, so as to cooperate with theforceps arms 131 to achieve the function of capturing the valve leaflets.

输送状态下，抓持部至少部分容纳在夹合部130的内表面中，即抓持臂151至少部分容纳在钳臂131的内表面中，从而减少了瓣膜夹合装置100的外径，利于输送。在钳臂131与抓持臂151配合捕捉瓣叶后，抓持臂151将瓣叶压入钳臂131的内表面中，可以增加钳臂131与瓣叶的接触面积、增加对瓣叶的夹持力。In the delivery state, the grasping portion is at least partially accommodated in the inner surface of the clampingportion 130, that is, thegrasping arm 151 is at least partially accommodated in the inner surface of theforceps arm 131, thereby reducing the outer diameter of thevalve clamping device 100 and facilitating the delivery. After theforceps arm 131 cooperates with thegrasping arm 151 to capture the valve leaflet, thegrasping arm 151 presses the valve leaflet into the inner surface of theforceps arm 131, which can increase the contact area between theforceps arm 131 and the valve leaflet and increase the clamping force on the valve leaflet. hold.

瓣膜夹合装置100还包括与支撑部110固定连接的基座160，每一钳臂131均转动连接于基座160上。具体地，基座160的近端与支撑部110的第一端111固定连接，应当说明，此处为了阐述方便将此部分定义为术语“基座”，实现该基座160功能的结构也可以是支撑部110的第一端111自身，因此定义术语“基座”不应形成对本申请范围的限制。每一组中的每个钳臂131在基座160上通过枢轴132转动连接在一起，调节部120的第一端121与基座160在轴向上间隔开，在驱动部140的驱动下，每个钳臂131彼此配合可以一起围绕调节部120展开和闭合。Thevalve clamping device 100 further includes a base 160 fixedly connected to thesupport portion 110 , and eachclamp arm 131 is rotatably connected to thebase 160 . Specifically, the proximal end of thebase 160 is fixedly connected to thefirst end 111 of thesupport portion 110. It should be noted that this part is defined as the term "base" for the convenience of explanation, and the structure for realizing the function of the base 160 may also be It is thefirst end 111 of thesupport portion 110 itself, so defining the term "base" should not form a limitation on the scope of the present application. Eachclamp arm 131 in each group is rotatably connected together on the base 160 through thepivot shaft 132 , thefirst end 121 of the adjustingpart 120 is spaced apart from the base 160 in the axial direction, and is driven by the drivingpart 140 , each of theclamp arms 131 can be deployed and closed together around the adjustingportion 120 in cooperation with each other.

本实施例中，驱动部140包括：驱动轴141、连接座142以及两个连杆143。其中，每个连杆143的一端与夹合部130转动连接，另一端与连接座142转动连接；驱动轴141的一端与连接座142固定连接，另一端活动地穿装在基座160中。具体地，每一连杆143的一端与一钳臂131转动连接，另一端通过枢轴144转动连接于连接座142，即，每一钳臂131通过相应一侧的连杆143转动连接于驱动轴141的连接座142。驱动轴141活动地穿过基座160，当驱动轴141相对于基座160沿轴向滑动时，带动连杆143转动并带动钳臂131以其与基座160的转动连接部位为中心展开或闭合。In this embodiment, the drivingpart 140 includes: a drivingshaft 141 , a connectingseat 142 and two connectingrods 143 . One end of each connectingrod 143 is rotatably connected with the clampingportion 130 , and the other end is rotatably connected with the connectingseat 142 ; Specifically, one end of eachlink 143 is rotatably connected to aclamp arm 131 , and the other end is rotatably connected to the connectingseat 142 through thepivot 144 , that is, eachclamp arm 131 is rotatably connected to the drive through thelink 143 on the corresponding side. Theconnection seat 142 of theshaft 141 . Thedrive shaft 141 movably passes through thebase 160. When thedrive shaft 141 slides relative to the base 160 in the axial direction, it drives the connectingrod 143 to rotate and drives theclamp arm 131 to expand or expand at the rotational connection portion with thebase 160. closure.

具体的，驱动部140包括至少一组连杆143，连杆143的设置与钳臂131的设置一一对应，例如图10中采用两个钳臂131，则相对应地设置两个配合工作的连杆143。连杆143的一端通过枢轴144如销钉等方式转动连接于连接座142上，另一端通过枢轴如销钉等方式转动连接于相应的钳臂131，每个钳臂131通过枢轴132如销钉等方式转动连接在基座160上。当驱动轴141沿轴向相对于基座160朝支撑部110的第一端111移动，带动连杆143运动，在连杆143的拉动下，钳臂131围绕枢轴132转动而相对于基座160张开。当驱动轴141沿轴向相对于基座160朝支撑部110的第二端115移动，连杆143推动钳臂131围绕枢轴132转动而相对于基座160闭合。连接座142的形状可为半球体、球冠或弹头形等任一结构，以使瓣膜夹合装置100更容易在体内进行推送。驱动轴141与连接座142可以是一体结构，也可以是非一体结构。为保证植入后的安全性，驱动轴141及连接座142由聚酯、硅树脂、不锈钢、钴合金、钴铬合金或钛合金等生物相容性材料制成，优选为硬度较高的不锈钢或钴铬合金。Specifically, the drivingpart 140 includes at least one set of connectingrods 143, and the settings of the connectingrods 143 correspond to the settings of theclamp arms 131 one-to-one. For example, if two clamparms 131 are used in FIG. connectingrod 143 . One end of the connectingrod 143 is rotatably connected to the connectingseat 142 through apivot 144 such as a pin, and the other end is rotatably connected to thecorresponding clamp arm 131 through a pivot such as a pin. Eachclamp arm 131 passes through thepivot 132 such as a pin It is rotatably connected to the base 160 in the same manner. When the drivingshaft 141 moves relative to the base 160 toward thefirst end 111 of thesupport portion 110 in the axial direction, the connectingrod 143 is driven to move. Under the pulling of the connectingrod 143 , theclamp arm 131 rotates around thepivot shaft 132 and is relative to the base 160 open. When thedrive shaft 141 moves toward thesecond end 115 of thesupport portion 110 relative to the base 160 in the axial direction, thelink 143 pushes theclamp arm 131 to rotate around thepivot 132 to be closed relative to thebase 160 . The shape of the connectingseat 142 can be any structure such as a hemisphere, a spherical cap or a bullet shape, so as to make thevalve clamping device 100 easier to push in the body. Thedrive shaft 141 and the connectingseat 142 may be of an integral structure or a non-integrated structure. In order to ensure the safety after implantation, thedrive shaft 141 and the connectingseat 142 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel with higher hardness or cobalt-chromium alloys.

优选地，参见图10所示，瓣膜夹合装置100还包括设于基座160中的锁定部170，锁定部170限制驱动轴141与基座160的相对运动。在输送状态时，锁定部170限制驱动轴141与基座160的相对运动，从而保证夹合部130相对于调节部120和支撑部110始终保持闭合状态，避免夹合部130的意外展开；在到达二尖瓣附近后，解锁锁定部170对驱动轴141的限制，即可通过驱动部140驱动夹合部130相对于调节部120和支撑部110展开并承托瓣叶；夹持瓣叶后，锁定部170再次限制驱动轴141与基座160的相对运动，从而保持对瓣叶1的夹紧状态。可采用现有的任意适合结构的锁定部，此处不再赘述。Preferably, as shown in FIG. 10 , thevalve clamping device 100 further includes a lockingportion 170 provided in thebase 160 , and the lockingportion 170 restricts the relative movement of thedrive shaft 141 and thebase 160 . In the delivery state, the lockingportion 170 restricts the relative movement of thedrive shaft 141 and thebase 160, so as to ensure that the clampingportion 130 is always in a closed state relative to the adjustingportion 120 and the supportingportion 110 to avoid accidental expansion of the clampingportion 130; After reaching the vicinity of the mitral valve, the restriction of the drivingshaft 141 by the lockingpart 170 is unlocked, and the clampingpart 130 can be driven by the drivingpart 140 to unfold relative to the adjustingpart 120 and the supportingpart 110 and support the valve leaflet; after clamping the valve leaflet , the lockingportion 170 limits the relative movement of thedrive shaft 141 and the base 160 again, so as to maintain the clamping state of thevalve leaflet 1 . The locking portion of any existing suitable structure can be used, and details are not described here.

结合图5与图9，进一步地，每一钳臂131的末端(将钳臂131远离其转动连接部位的一端或者说自由端定义为钳臂131的末端)还设有翻边段137，从图9的主视视角看，翻边段137呈朝向钳臂131的末端的外侧翻转的弧面，该弧面的半径优选1mm-2mm。当钳臂131相对调节部120闭合以在二者之间夹持瓣叶1时，瓣叶1与弧面的翻边段137形成贴合，增大钳臂131末端对瓣叶1的承托面积，能够避免瓣叶1在钳臂131末端局部受力集中，有效减轻钳臂131末端边缘随着心脏跳动与瓣叶1之间反复摩擦对瓣叶的损伤。钳臂131贴靠至调节部120后，调节部120的自扩展主体125在轴向上突出于翻边段137，或者说自扩展主体125的第二区段126高于翻边段137，以保证钳臂131与自扩展主体125的第三区段128之间所夹持的瓣叶1的长度不小于钳臂131的长度。5 and 9, further, the end of each clamp arm 131 (the end of theclamp arm 131 away from its rotational connection part or the free end is defined as the end of the clamp arm 131) is further provided with aflange section 137, from From the front view of FIG. 9 , theflanging section 137 is an arc surface turned toward the outer side of the distal end of theclamp arm 131 , and the radius of the arc surface is preferably 1 mm-2 mm. When theforceps arm 131 is closed relative to the adjustingportion 120 to clamp thevalve leaflet 1 therebetween, thevalve leaflet 1 and thecambered flanging section 137 form a fit, increasing the support of the end of theforceps arm 131 to thevalve leaflet 1 The area can avoid the local force concentration of thevalve leaflet 1 at the end of theforceps arm 131, and effectively reduce the damage to the valve leaflet caused by repeated friction between the end edge of theforceps arm 131 and thevalve leaflet 1 with the beating of the heart. After theclamp arm 131 is pressed against the adjustingportion 120 , the self-expandingbody 125 of the adjustingportion 120 protrudes from theflange section 137 in the axial direction, or thesecond section 126 of the self-expandingmain body 125 is higher than theflange section 137 , so as to It is ensured that the length of theleaflet 1 clamped between theforceps arm 131 and thethird section 128 of the self-expandingbody 125 is not less than the length of theforceps arm 131 .

参阅图13-图17，本发明还提供一种瓣膜夹合系统，包括上述瓣膜夹合装置100、以及输送装置200，其中，输送装置200包括：具有一定轴向长度的推送鞘管210及活动地穿装在推送鞘管210中的芯轴(图中未示出)，推送鞘管210与支撑部110之间可拆卸连接，芯轴与驱动部140可拆卸连接，用于驱动夹合部130的展开和闭合。本实施例中，驱动轴141的近端设置外螺纹，芯轴与驱动轴141之间通过螺纹连接，从而可在患者体外通过芯轴来控制驱动轴141的轴向运动。应当知晓，此处列出的仅是输送装置的部分结构，其他部分可采用现有的任一适合的结构，此处不再赘述。13-17, the present invention also provides a valve clamping system, including the above-mentionedvalve clamping device 100 and adelivery device 200, wherein thedelivery device 200 includes: a pushingsheath 210 having a certain axial length and a movable The mandrel (not shown in the figure) is inserted into thepush sheath tube 210, thepush sheath tube 210 and thesupport part 110 are detachably connected, and the mandrel and the drivingpart 140 are detachably connected for driving the clamping part. 130 expansion and closure. In this embodiment, the proximal end of thedrive shaft 141 is provided with external threads, and the mandrel and thedrive shaft 141 are connected by threads, so that the axial movement of thedrive shaft 141 can be controlled by the mandrel outside the patient's body. It should be known that what is listed here is only a part of the structure of the delivery device, and other parts can adopt any existing suitable structure, which will not be repeated here.

具体地，支撑部110的近端外壁对称开设有连通于支撑部110的管腔的至少一卡位114，推送鞘管210远端设有一连接件220，连接件220包括两个分支，每个分支的末端为凸起的卡台221。在自然状态，两个分支均指向连接件220的中心轴处。组装时，将连接件220插入支撑部110中，再将输送装置200的芯轴插入推送鞘管210中，直至芯轴插入连接件220中，将连接件220的两个分支向外顶起，分支末端的卡台221卡入支撑部110的两个卡位114中，从而将支撑部110与连接件220连接，即，将瓣膜夹合装置100和输送装置200相连。当将芯轴自连接件220及推送鞘管210中撤出，两个分支恢复向内的自然状态，卡台221从支撑部110的卡位114中脱离，使得瓣膜夹合装置100与输送装置200之间解除连接。连接件220可由镍钛等具有一定硬度及弹性的材料制成。推送鞘管210可采用多层复合管体。芯轴可为不锈钢材料或镍钛合金材料制成。Specifically, the outer wall of the proximal end of thesupport portion 110 is symmetrically provided with at least oneclamping position 114 communicating with the lumen of thesupport portion 110, and the distal end of thepush sheath 210 is provided with a connectingpiece 220. The connectingpiece 220 includes two branches, each of which is The end of the branch is a raised card table 221 . In the natural state, both branches point to the central axis of theconnector 220 . During assembly, theconnector 220 is inserted into thesupport portion 110, and then the mandrel of thedelivery device 200 is inserted into thepush sheath 210 until the mandrel is inserted into theconnector 220, and the two branches of theconnector 220 are pushed outwards. The clamping table 221 at the branch end is clamped into the two clampingpositions 114 of thesupport part 110 , so as to connect thesupport part 110 with the connectingpiece 220 , that is, connect thevalve clamping device 100 and thedelivery device 200 . When the mandrel is withdrawn from theconnector 220 and thepush sheath 210, the two branches return to their natural inward state, and the clamping table 221 is disengaged from theclamping position 114 of thesupport portion 110, so that thevalve clamping device 100 and the delivery device are separated. Disconnect between 200. The connectingmember 220 can be made of a material with certain hardness and elasticity, such as nickel titanium. Thepush sheath 210 can use a multi-layer composite tube body. The mandrel can be made of stainless steel or Nitinol.

结合图11与图13，支撑部110的内部设有通孔作为驱动轴141的穿设通道113，驱动轴141沿轴向滑动地穿设于支撑部110的穿设通道113内并与连接座142固定连接。在夹合部130和抓持部150配合并捕捉到瓣叶后，通过芯轴带动驱动轴141沿轴向移动，以带动钳臂131相对于支撑部110完全闭合，使瓣膜夹合装置100处于闭合状态，坠于瓣膜下方。之后可以解脱芯轴与驱动轴141之间的连接，芯轴自连接件220之间后撤，卡台221自支撑部110的卡位114中分离，从而实现瓣膜夹合装置100和输送装置200的解脱。11 and FIG. 13 , a through hole is provided inside thesupport portion 110 as apassage 113 for thedrive shaft 141 , and thedrive shaft 141 is axially slidably passed through thepassage 113 of thesupport portion 110 and is connected to the connecting seat. 142 fixed connections. After the clampingportion 130 and the grasping portion 150 are matched and captured the valve leaflet, thedrive shaft 141 is driven to move in the axial direction by the mandrel, so as to drive theforceps arm 131 to be completely closed relative to the supportingportion 110, so that thevalve clamping device 100 is in the position In the closed state, it falls below the valve. Afterwards, the connection between the mandrel and thedrive shaft 141 can be disengaged, the mandrel withdraws from theconnector 220 , and the clamping table 221 is separated from theclamping position 114 of thesupport portion 110 , thereby realizing thevalve clamping device 100 and thedelivery device 200 of liberation.

参阅图14-图18，以下以经导管途径经房间隔-左心房顺行接近并修复二尖瓣为例，阐述本申请的瓣膜夹合装置100的使用过程：Referring to FIGS. 14-18 , the following uses the transcatheter approach to approach and repair the mitral valve through the transatrial septum-left atrium antegrade as an example to illustrate the use process of thevalve clamping device 100 of the present application:

第一步：如图14所示，通过可调弯鞘管等导引装置(图未示出)将驱动轴141及与其相连的瓣膜夹合装置100从左心房2推进，经过二尖瓣1到达左心室3；Step 1: As shown in FIG. 14, thedrive shaft 141 and thevalve clamping device 100 connected to it are advanced from theleft atrium 2 through themitral valve 1 through a guide device such as an adjustable sheath (not shown). reachleft ventricle 3;

第二步：调整瓣膜夹合装置100接近二尖瓣1的前叶1a和后叶1b；The second step: adjusting thevalve clamping device 100 to be close to theanterior leaflet 1a and theposterior leaflet 1b of themitral valve 1;

第三步：如图15所示，解锁基座160中的锁定部170，向远端推动芯轴及驱动轴141，驱动钳臂131相对于支撑部110张开，调整钳臂131方向，此时可通过X射线设备观察钳臂131与二尖瓣1的前叶1a和后叶1b的相对位置，使得钳臂131垂直于二尖瓣1的对合线；Step 3: As shown in FIG. 15 , unlock the lockingportion 170 in thebase 160, push the mandrel and thedrive shaft 141 to the distal end, drive theclamp arm 131 to open relative to thesupport portion 110, and adjust the direction of theclamp arm 131. The relative positions of theforceps arm 131 and theanterior leaflet 1a and theposterior leaflet 1b of themitral valve 1 can be observed through the X-ray equipment, so that theforceps arm 131 is perpendicular to the coaptation line of themitral valve 1;

第四步：如图16所示，向近端回撤整个瓣膜夹合装置100，使钳臂131在左心室3侧托住瓣叶1，释放两侧的抓持臂151，每侧的抓持臂151在心房侧压住瓣叶1并与该侧的钳臂131配合捕捉住瓣叶1；Step 4: As shown in FIG. 16 , withdraw the entirevalve clamping device 100 proximally, so that theclamp arms 131 hold thevalve leaflet 1 on theleft ventricle 3 side, release the graspingarms 151 on both sides, and the graspingarms 151 on each side. The holdingarm 151 presses thevalve leaflet 1 on the atrial side and cooperates with theclamp arm 131 on the side to capture thevalve leaflet 1;

第五步：如图17所示，当二尖瓣1的前叶1a和后叶1b分别被捕捉在一对钳臂131和抓持臂151之间，向近端拉动芯轴及驱动轴141，从而驱动钳臂131闭合；Step 5: As shown in FIG. 17, when theanterior leaflet 1a and theposterior leaflet 1b of themitral valve 1 are captured between the pair ofclamp arms 131 and thegrasping arm 151, respectively, pull the mandrel and thedrive shaft 141 toward the proximal end , thereby driving theclamp arm 131 to close;

第六步：解脱芯轴与驱动轴141之间的螺纹连接，并后撤芯轴，连接件220的两个分支恢复向中心轴靠拢的状态，卡台221自支撑部110的卡位114中分离，瓣膜夹合装置100与输送装置200之间的连接解除，之后将输送装置200撤出体外，得到如图18所示的植入状态，此时瓣膜夹合装置100将二尖瓣1的前叶1a和后叶1b拉向彼此，得到双孔化的二尖瓣，完成二尖瓣的缘对缘修复。Step 6: Release the threaded connection between the mandrel and thedrive shaft 141 , and withdraw the mandrel, the two branches of the connectingpiece 220 are restored to the state of being close to the central axis, and the clamping table 221 is locked in theposition 114 of the supportingportion 110 . Separation, the connection between thevalve clamping device 100 and thedelivery device 200 is released, and then thedelivery device 200 is withdrawn from the body to obtain the implantation state shown in FIG. 18 . Theanterior leaflet 1a and theposterior leaflet 1b are drawn toward each other, resulting in a biported mitral valve, completing edge-to-edge repair of the mitral valve.

瓣膜夹合装置100植入后，具有弹性的调节部120填充于被夹持的二尖瓣1的前叶1a和后叶1b之间，且为瓣叶1提供径向支撑力，调节部120对于搏动的瓣叶1具有缓冲作用，从而实现瓣膜夹合装置100对瓣叶1的牵拉程度可调节，以避免损伤瓣叶1。After thevalve clamping device 100 is implanted, theelastic adjusting portion 120 is filled between theanterior leaflet 1a and theposterior leaflet 1b of the clampedmitral valve 1, and provides radial support for thevalve leaflet 1, the adjustingportion 120 It has a buffering effect on the pulsatingvalve leaflet 1 , so that the degree of pulling of thevalve leaflet 1 by thevalve clamping device 100 can be adjusted to avoid damage to thevalve leaflet 1 .

实施例二Embodiment 2

请参阅图19至图21，本发明第二实施例提供的瓣膜夹合装置100’与上述第一实施例的瓣膜夹合装置100相比较，支撑部110、夹合部130、驱动部140、抓持部151等的结构保持不变，此处不再赘述，但调节部120’的结构发生了变化。Referring to FIGS. 19 to 21 , thevalve clamping device 100 ′ provided by the second embodiment of the present invention is compared with thevalve clamping device 100 of the above-mentioned first embodiment. The structures of thegripping portion 151 and the like remain unchanged, and will not be repeated here, but the structure of the adjustingportion 120 ′ has been changed.

具体的，在该第二实施例中，调节部120’相比第一实施例中的调节部120对自扩展主体增设了弯折区段129，弯折区段129连接于调节部120’的第二端123与自扩展主体的第一区段124之间，优选的，弯折区段129的截面形状呈朝向调节部120’的第一端121凹陷的弧形。第一区段124与弯折区段129相对第二区段126仍形成一凹陷区122’，凹陷区122’的末端(将弯折区段129靠近调节部120’的第二端123的一端定义为凹陷区122’的末端)朝向支撑部110的第二端115延伸至调节部120’的第二端123。Specifically, in the second embodiment, compared with the adjustingportion 120 in the first embodiment, the adjustingportion 120 ′ adds abending section 129 to the self-expanding body, and thebending section 129 is connected to the adjustingportion 120 ′. Between thesecond end 123 and thefirst section 124 of the self-expanding body, preferably, the cross-sectional shape of thebending section 129 is an arc shape concave toward thefirst end 121 of the adjusting portion 120'. Thefirst section 124 and thebending section 129 still form a concave area 122' relative to thesecond section 126. Defined as the end of the recessed area 122') extends toward thesecond end 115 of thesupport portion 110 to thesecond end 123 of the adjustment portion 120'.

制作该调节部120’时，首先准备一两端开放的编织网管，将编织网管套设在一衬棒上，然后将一成型套套设在该编织网管的上端外，形成调节件120’的第二端123；接着向上(以图20中调节部120’的第二端123所在的方位为上、第一端121所在的方位为下，)推动编织网管的下端，并借助成型模具对该编织网管进行热定型处理，形成如图20与图21所示的整体外形仍近似呈倒锥体形的调节部120’，且该编织网管的下端于该编织网管的上端的下方形成调节件120’的具有开口的第一端121，取下成型套及成型模具，即得到调节部120’。When making the adjustment part 120', first prepare a braided mesh tube with open ends, sleeve the braided mesh tube on a lining rod, and then sleeve a forming sleeve over the upper end of the braided mesh tube to form the first part of the adjustment part 120'. Two ends 123; then upward (with the orientation of thesecond end 123 of the adjusting portion 120' in FIG. 20 being up and the orientation of thefirst end 121 being down), push the lower end of the braided mesh tube, and use the forming die to weave the The mesh tube is subjected to heat-setting treatment to form an adjustment portion 120' with an overall shape as shown in Figure 20 and Figure 21 that is still approximately an inverted cone shape, and the lower end of the braided mesh tube forms the adjustment member 120' below the upper end of the braided mesh tube. With thefirst end 121 having an opening, the forming sleeve and the forming die are removed to obtain the adjusting portion 120'.

调节部120’与支撑部110组装时，将支撑部110的第二端115与第一端111之间的部分穿设于调节部120的中空容纳腔体内，调节部120’的第二端123通过固定件80与支撑部110固定连接，固定件80可以是钢套，调节部120的第二端123穿装于钢套与支撑部110的外表面之间，再通过激光焊接钢套与支撑部110实现调节部120’的第二端123与支撑部110的固定连接。本实施例中，调节部120’的第二端123朝向支撑部110的第二端115穿装入固定件80，即调节部120’的第二端123从下向上穿装入固定件80。When the adjusting part 120' is assembled with the supportingpart 110, the part between thesecond end 115 and thefirst end 111 of the supportingpart 110 is inserted into the hollow receiving cavity of the adjustingpart 120, and thesecond end 123 of the adjusting part 120' The fixingmember 80 is fixedly connected to thesupport portion 110, and the fixingmember 80 may be a steel sleeve. Thesecond end 123 of the adjustingportion 120 is inserted between the steel sleeve and the outer surface of thesupport portion 110, and then the steel sleeve and the support are welded by laser. Thepart 110 realizes the fixed connection between thesecond end 123 of the adjustingpart 120 ′ and the supportingpart 110 . In this embodiment, thesecond end 123 of the adjusting portion 120' is inserted into the fixingmember 80 toward thesecond end 115 of the supportingportion 110, that is, thesecond end 123 of the adjusting portion 120' is inserted into the fixingmember 80 from bottom to top.

在瓣膜夹合装置100’的闭合状态下，弯折区段129抵抗第一区段124的向内变形，这种抵抗作用叠加传递至与第二区段126相连的第三区段128的相应部分上，进一步提升瓣叶与调节部120的弹性贴合性，使得瓣叶与调节部120能够充分贴合。相应地，调节部120能够为瓣叶提供更大的径向支撑力，进而进一步提高夹持力以牢靠地夹持住瓣叶。In the closed state of thevalve clamping device 100 ′, theflexure section 129 resists the inward deformation of thefirst section 124 , and this resistance is superimposed on the correspondingthird section 128 connected to thesecond section 126 . In part, the elastic fit between the valve leaflet and theadjustment part 120 is further improved, so that the valve leaflet and theadjustment part 120 can fully fit. Correspondingly, the adjustingportion 120 can provide a larger radial support force for the valve leaflet, thereby further increasing the clamping force to firmly hold the valve leaflet.

实施例三Embodiment 3

如图22所示，本发明第三实施例提供的瓣膜夹合装置与上述第一实施例的瓣膜夹合装置相比较，支撑部、夹合部、驱动部、抓持部等的结构保持不变，此处不再赘述，但调节部的自扩展主体125’的结构发生了变化。As shown in FIG. 22 , the valve clamping device provided by the third embodiment of the present invention, compared with the valve clamping device of the first embodiment, the structures of the supporting part, the clamping part, the driving part, the grasping part, etc. remain unchanged. The structure of the self-expandingmain body 125 ′ of the adjusting part has been changed.

该实施例三中的自扩展主体125’除了包括第一区段124、第二区段126与第三区段128之外，还包括适配段127。适配段127连接于第二区段126与第三区段128之间，且相较于第三区段128径向向外延伸(以朝向支撑部110的中轴线为径向向内，以背离支撑部110的中轴线为径向向外)。该适配段127对应钳臂末端的翻边段137设置，其朝向翻边段137的一侧的形状与翻边段137所呈现的弧面互补。In addition to thefirst section 124, thesecond section 126 and thethird section 128, the self-expanding body 125' in the third embodiment also includes anadapting section 127. The adaptingsegment 127 is connected between thesecond segment 126 and thethird segment 128 and extends radially outward compared to the third segment 128 (radially inward toward the central axis of thesupport portion 110 , to The central axis away from thesupport portion 110 is radially outward). Thefitting section 127 is disposed corresponding to theflanging section 137 at the end of the clamp arm, and the shape of the side facing theflanging section 137 is complementary to the arc surface presented by theflanging section 137 .

当钳臂相对调节部120闭合以在二者之间夹持瓣叶时，适配段127在轴向上突出于翻边段137，或者说适配段127高于翻边段137，适配段127与翻边段137之间也夹持部分瓣叶，一方面瓣叶与翻边段137的弧面形成贴合，增大钳臂末端对瓣叶的承托面积，能够避免瓣叶在钳臂末端局部受力集中，有效减轻钳臂末端边缘随着心脏跳动与瓣叶之间反复摩擦对瓣叶的损伤；另一方面，瓣叶亦与弧形的适配段127形成贴合，进一步增加瓣叶与调节部的贴合面积，提升瓣叶与调节部的弹性贴合性，使得瓣叶与调节部贴合地更为充分，相应地，调节部能够为瓣叶提供更充足的径向支撑力，进而进一步提高夹持力以牢靠地夹持住瓣叶。When the forceps arm is closed relative to the adjustingportion 120 to clamp the valve leaflet therebetween, thefitting segment 127 protrudes from theflange segment 137 in the axial direction, or thefitting segment 127 is higher than theflange segment 137, and thefitting segment 127 is higher than theflange segment 137. Part of the valve leaflet is also clamped between thesegment 127 and theflanged segment 137. On the one hand, the valve leaflet and the arc surface of theflanged segment 137 form a fit, which increases the bearing area of the valve leaflet at the end of the clamp arm, which can prevent the valve leaflet from being damaged. The force at the end of the forceps arm is concentrated locally, which effectively reduces the damage to the valve leaflet caused by repeated friction between the end edge of the forceps arm and the valve leaflet along with the beating of the heart; Further increase the fitting area between the valve leaflet and the adjustment part, and improve the elastic fit between the valve leaflet and the adjustment part, so that the valve leaflet and the adjustment part fit more fully, and accordingly, the adjustment part can provide more sufficient space for the valve leaflet. Radial support force, which in turn further increases the clamping force to hold the leaflets securely.

实施例四Embodiment 4

请参阅图23至图25，本发明第四实施例提供的瓣膜夹合装置400与上述第一实施例的瓣膜夹合装置100相比较，调节部120的结构保持不变，此处不再赘述，但支撑部410、夹合部430、驱动部440的结构有所变化。Referring to FIGS. 23 to 25 , thevalve clamping device 400 provided by the fourth embodiment of the present invention is compared with thevalve clamping device 100 of the first embodiment, and the structure of the adjustingportion 120 remains unchanged, and details are not repeated here. , but the structures of the supportingpart 410 , the clampingpart 430 and the drivingpart 440 are changed.

具体的，在该第四实施例中，夹合部430包括至少两个钳臂，一般可以包括至少一组钳臂，每一组钳臂包括相对于调节部120对称设置的两个钳臂，本实施例中的夹合部40包括一组钳臂。每一钳臂上设有至少一个锚定件431，当钳臂相对于调节部120闭合时，锚定件431能够抵顶瓣叶使其嵌置于网状结构的调节部120的网格中，以在调节部120与钳臂夹持瓣叶的基础上，通过锚定件431保持瓣叶组织。Specifically, in the fourth embodiment, the clampingportion 430 includes at least two clamp arms, generally at least one group of clamp arms, each group of clamp arms includes two clamp arms symmetrically arranged relative to the adjustingportion 120 , The clamping portion 40 in this embodiment includes a set of clamp arms. Each forceps arm is provided with at least oneanchoring piece 431 , when the forceps arm is closed relative to the adjustingportion 120 , theanchoring piece 431 can abut against the top leaflet so that it is embedded in the grid of the adjustingportion 120 of the mesh structure , so as to hold the valve leaflet tissue through the anchoringmember 431 on the basis that the adjustingportion 120 and the forceps arm clamp the valve leaflet.

驱动部440包括驱动轴410、自动闭合单元445以及至少两个连杆443。其中，每个所述连杆443的一端与相应的一钳臂转动连接，另一端通过销轴直接与驱动轴441转动连接；驱动轴441活动穿装于支撑部410中；自动闭合单元445连接两钳臂，用于使得夹合部430在自然状态下贴靠调节部120。The drivingpart 440 includes a drivingshaft 410 , anautomatic closing unit 445 and at least two connectingrods 443 . Wherein, one end of each of the connectingrods 443 is rotatably connected with a corresponding clamp arm, and the other end is directly rotatably connected with thedrive shaft 441 through a pin shaft; thedrive shaft 441 is movably fitted in thesupport portion 410; theautomatic closing unit 445 is connected The two clamp arms are used to make the clampingpart 430 abut against the adjustingpart 120 in a natural state.

基座416与支撑部410的第一端411为一体结构，两钳臂转动连接于基座416。支撑部410上开设有供销轴穿过的轴向槽419。当驱动轴441带动销轴在轴向槽419内向支撑部410的第一端411移动时，带动连杆443克服自动闭合单元445的阻挠而使得两钳臂相对打开。Thebase 416 is integral with thefirst end 411 of thesupport portion 410 , and the two clamp arms are rotatably connected to thebase 416 . Thesupport portion 410 is provided with anaxial groove 419 for the pin shaft to pass through. When thedrive shaft 441 drives the pin to move toward thefirst end 411 of thesupport portion 410 in theaxial groove 419 , thedrive link 443 overcomes the resistance of theautomatic closing unit 445 to make the two clamp arms relatively open.

本实施例中，所述自动闭合单元445为U形弹片，U形弹片的两端分别连接一钳臂，当驱动轴441不对销轴施加推力时，U形弹片利用自身复位带动两钳臂趋向闭合而贴靠调节部120。可以理解的是，在其他实施例中，自动闭合单元445还可以为V形弹片或扭簧等弹性件。In this embodiment, theautomatic closing unit 445 is a U-shaped shrapnel, and two ends of the U-shaped shrapnel are respectively connected with a clamp arm. When the drivingshaft 441 does not exert a thrust on the pin shaft, the U-shaped shrapnel uses its own reset to drive the two clamp arms to tend to Close and abut against theadjustment part 120 . It can be understood that, in other embodiments, theautomatic closing unit 445 may also be an elastic member such as a V-shaped elastic sheet or a torsion spring.

实施例五Embodiment 5

请参阅图26，本发明第五实施例提供的瓣膜夹合装置400’与上述第四实施例的瓣膜夹合装置400相比较，将第四实施例中的调节部120替换为第二实施例中的调节部120’，其他结构保持不变，此处不再赘述。Referring to FIG. 26 , thevalve clamping device 400 ′ provided in the fifth embodiment of the present invention is compared with thevalve clamping device 400 in the above-mentioned fourth embodiment, and the adjustingpart 120 in the fourth embodiment is replaced by the second embodiment Theadjustment part 120 ′ in the above, and other structures remain unchanged, and will not be repeated here.

实施例六Embodiment 6

请参阅图27与图28，本发明第六实施例提供的瓣膜夹合装置500与上述第一实施例的瓣膜夹合装置100相比较，调节部120的结构保持不变，此处不再赘述，但夹合部530、驱动部540等的结构有所变化。Please refer to FIG. 27 and FIG. 28 . Compared with thevalve clamping device 100 according to the first embodiment, thevalve clamping device 500 provided by the sixth embodiment of the present invention has the same structure of the adjustingportion 120 , and details are not repeated here. , but the structures of the clampingpart 530 and the drivingpart 540 are changed.

该实施例中，基座516与支撑部510的第一端511为一体结构，夹合部530的钳臂的一端连接于基座516。驱动部540包括驱动轴541以及至少两个弹性驱动臂545，弹性驱动臂545的一端固定连接驱动轴541的一端，弹性驱动臂545的另一端连接钳臂的另一端，驱动轴545的另一端活动穿装于支撑部510中；弹性驱动臂545用于使得夹合部530在自然状态下贴靠调节部120；抓持臂551的一端连接于夹合部530的钳臂上，且在瓣膜夹合装置500的展开状态下，抓持臂551受输送装置内拉线(图未示)的控制而相对钳臂张开，以允许瓣叶进入抓持臂551与钳臂之间。In this embodiment, thebase 516 is integrally formed with thefirst end 511 of thesupport portion 510 , and one end of the clamp arm of the clampingportion 530 is connected to thebase 516 . The drivingpart 540 includes a drivingshaft 541 and at least two elastic drivingarms 545 , one end of theelastic driving arm 545 is fixedly connected to one end of the drivingshaft 541 , the other end of theelastic driving arm 545 is connected to the other end of the clamp arm, and the other end of the drivingshaft 545 Theelastic driving arm 545 is used to make the clampingpart 530 abut against the adjustingpart 120 in a natural state; one end of thegrasping arm 551 is connected to the clamp arm of the clampingpart 530, and is in the valve In the unfolded state of theclamping device 500, thegrasping arm 551 is controlled by the inner pull wire (not shown) of the delivery device to expand relative to the forceps arm, so as to allow the valve leaflet to enter between thegrasping arm 551 and the forceps arm.

本实施例中，两钳臂及两弹性驱动臂545为一体结构，即两钳臂自身也是具有弹性的。当驱动轴541朝向支撑部510的第一端511移动时，克服两弹性驱动臂545的阻挠而使得两钳臂相对打开；当驱动轴541不对弹性驱动臂545施加推力时，两弹性驱动臂545利用自身复位而带动两钳臂趋向闭合而贴靠调节部120。值得注意的是，当驱动轴541朝向支撑部510的第一端511持续推动时，可使得钳臂与驱动臂545的连接处逐渐朝向驱动轴541靠近，直至钳臂与驱动臂545基本处于一条直线上，再利用拉线控制抓持臂551贴合调节部120，此种状态下，更易于将扁平化的整个瓣膜夹合装置500收入鞘管内。In this embodiment, the two clamp arms and the two elastic drivingarms 545 are integral structures, that is, the two clamp arms are also elastic. When thedrive shaft 541 moves toward thefirst end 511 of thesupport portion 510 , the two clamp arms are relatively opened against the resistance of the twoelastic drive arms 545 ; when thedrive shaft 541 does not push theelastic drive arms 545 , the twoelastic drive arms 545 By self-resetting, the two clamp arms are driven to close and abut against the adjustingportion 120 . It is worth noting that when thedrive shaft 541 is continuously pushed toward thefirst end 511 of thesupport portion 510, the connection between the clamp arm and thedrive arm 545 can be gradually approached toward thedrive shaft 541 until the clamp arm and thedrive arm 545 are substantially aligned In a straight line, thegripping arm 551 is controlled to fit the adjustingportion 120 by the pulling wire. In this state, it is easier to put the entire flattenedvalve clamping device 500 into the sheath.

此外，该实施例的瓣膜夹合装置500能够实现对瓣叶夹合状态的动态平衡：当瓣叶对该瓣膜夹合装置500施加较大的牵拉力时，具有弹性的驱动臂545及钳臂能够在一定范围内调节夹合角度又不会与瓣叶脱离，防止瓣叶受到过大的牵拉力而损伤。In addition, thevalve clamping device 500 of this embodiment can realize the dynamic balance of the clamping state of the valve leaflets: when the valve leaflets exert a large pulling force on thevalve clamping device 500, theelastic driving arm 545 and the forceps The arm can adjust the clamping angle within a certain range without being separated from the valve leaflet, so as to prevent the valve leaflet from being damaged by excessive pulling force.

实施例七Embodiment 7

请参阅图29，本发明第七实施例提供的瓣膜夹合装置500’与上述第六实施例的瓣膜夹合装置500相比较，将第六实施例中的调节部120替换为第二实施例中的调节部120’，其他结构保持不变，此处不再赘述。Referring to FIG. 29 , thevalve clamping device 500 ′ provided in the seventh embodiment of the present invention is compared with thevalve clamping device 500 in the sixth embodiment, and the adjustingpart 120 in the sixth embodiment is replaced by the second embodiment Theadjustment part 120 ′ in the above, and other structures remain unchanged, and will not be repeated here.

实施例八Embodiment 8

请参阅图30与图31，本发明第八实施例提供的瓣膜夹合装置600与上述第一实施例的瓣膜夹合装置100相比较，仅支撑部610的结构发生变化，其它结构保持不变，此处不再赘述。Please refer to FIG. 30 and FIG. 31 . Compared with thevalve clamping device 100 according to the first embodiment, only the structure of thesupport portion 610 is changed, and the other structures remain unchanged. , and will not be repeated here.

该实施例中，支撑部610与输送装置200’的连接部位不再像第一实施例那样设置于第二端，而是在支撑部610第一端的基座660上设置连接部670，该连接部670与输送装置200’的推送鞘管可拆卸连接。具体的，该连接部670与输送装置200’的推送鞘管上分别设置形状互补的拼接结构，推送鞘管外活动套设一外鞘管70，当外鞘管70包绕所述形状互补的拼接结构时，支撑部610与输送装置200’保持连接，当外鞘管70后撤并暴露出所述形状互补的拼接结构时，支撑部610与输送装置200’可解除连接。In this embodiment, the connecting portion between thesupport portion 610 and the conveyingdevice 200 ′ is no longer provided at the second end as in the first embodiment, but a connectingportion 670 is provided on the base 660 at the first end of thesupport portion 610 . The connectingportion 670 is detachably connected to the push sheath of the delivery device 200'. Specifically, the connectingportion 670 and the push sheath tube of the delivery device 200' are respectively provided with splicing structures with complementary shapes, and anouter sheath tube 70 is movably sleeved outside the push sheath tube. When theouter sheath tube 70 surrounds the complementary shape During the splicing structure, thesupport portion 610 is kept connected with thedelivery device 200 ′, and when theouter sheath 70 is withdrawn to expose the spliced structure of complementary shape, thesupport portion 610 and thedelivery device 200 ′ can be disconnected.

如图31所示，该实施例的输送装置200’可通过经心尖的方式将该瓣膜夹合装置600推送至心脏内对二尖瓣实施缘对缘修复。需要注意的是，在两钳臂完成闭合之前，外鞘管70应保持包绕所述形状互补的拼接结构；在两钳臂完成闭合之后，先解脱芯轴与驱动轴之间的螺纹连接，并后撤芯轴，然后后撤外鞘管70使得所述拼接结构暴露，便可解除瓣膜夹合装置600与输送装置200’之间的连接。As shown in FIG. 31 , the delivery device 200' of this embodiment can push thevalve clamping device 600 into the heart through a transapical manner to perform edge-to-edge repair of the mitral valve. It should be noted that, before the two clamp arms are closed, theouter sheath tube 70 should keep surrounding the splicing structure with complementary shapes; after the two clamp arms are closed, the threaded connection between the mandrel and the drive shaft is first released, The mandrel is withdrawn, and then theouter sheath 70 is withdrawn to expose the splicing structure, and the connection between thevalve clamping device 600 and the delivery device 200' can be released.

可以理解的是，本发明提供的瓣膜夹合系统包括上述的任一瓣膜夹合装置以及能够将该瓣膜夹合装置从体外输送至二尖瓣附近并夹合瓣叶的输送装置。It can be understood that the valve clamping system provided by the present invention includes any of the above-mentioned valve clamping devices and a delivery device capable of delivering the valve clamping device to the vicinity of the mitral valve from outside the body and clamping the valve leaflets.

可以理解的是，本发明提供的瓣膜夹合装置及瓣膜夹合系统也可以对三尖瓣实施缘对缘修复，只要选择相应的介入路径(如股静脉-下腔静脉-右心房-右心室)以及根据需要修复的瓣叶数量植入适合数量的瓣膜夹合装置即可(如植入三个瓣膜夹合装置分别夹持三尖瓣的前叶与后叶、后叶与隔叶、隔叶与前叶)。It can be understood that the valve clamping device and valve clamping system provided by the present invention can also perform edge-to-edge repair on the tricuspid valve, as long as the corresponding interventional route (such as femoral vein-inferior vena cava-right atrium-right ventricle) is selected. ) and the appropriate number of valve clamping devices can be implanted according to the number of valve leaflets to be repaired (for example, three valve clamping devices are implanted to clamp the anterior leaflet and posterior leaflet, posterior leaflet and septal leaflet, and septal leaflet of tricuspid valve respectively. leaves and anterior leaves).

以上所述仅是本发明的具体实施例，使本领域技术人员能够理解或实现本发明。对这些实施例的多种修改对本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所申请的原理和新颖特点相一致的最宽的范围。The above descriptions are only specific embodiments of the present invention, so that those skilled in the art can understand or implement the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims (19)

Translated fromChinese

1.一种贴合充分的瓣膜夹合装置，其特征在于，包括：1. a fully fitted valve clamping device is characterized in that, comprising:支撑部，所述支撑部具有一定轴向长度，且包括相对设置的第一端和第二端；a support part, the support part has a certain axial length and includes a first end and a second end arranged oppositely;调节部，所述调节部包括相对设置的第一端和第二端、以及位于所述第一端和所述第二端之间的自扩展主体；所述调节部的第一端活动套设在所述支撑部的外侧，所述调节部的第二端套设在所述支撑部的外侧并与所述支撑部固定连接，所述调节部的第一端位于所述支撑部的第一端与所述调节部的第二端之间；an adjustment part, the adjustment part includes a first end and a second end arranged oppositely, and a self-expanding body located between the first end and the second end; the first end of the adjustment part is movably sleeved On the outside of the support part, the second end of the adjustment part is sleeved on the outside of the support part and is fixedly connected with the support part, and the first end of the adjustment part is located at the first end of the support part between the end and the second end of the adjusting portion;夹合部，所述夹合部设于所述支撑部的外侧并可相对于所述调节部展开或闭合。The clamping part is arranged on the outer side of the supporting part and can be unfolded or closed relative to the adjusting part.2.根据权利要求1所述的贴合充分的瓣膜夹合装置，其特征在于，所述自扩展主体在自然状态下的直径自所述调节部的第一端向所述调节部的第二端逐渐增大。2 . The adequately fitted valve clamping device according to claim 1 , wherein the diameter of the self-expanding body in a natural state is from the first end of the adjustment part to the second end of the adjustment part. 3 . ends gradually increase.3.根据权利要求2所述的贴合充分的瓣膜夹合装置，其特征在于，所述自扩展主体为形状记忆材料制成的网状结构。3 . The fully fitted valve clamping device according to claim 2 , wherein the self-expanding body is a mesh structure made of shape memory material. 4 .4.根据权利要求3所述的贴合充分的瓣膜夹合装置，其特征在于，所述网状结构的外部和/或内部覆盖有生物相容性薄膜。4. The fully fitted valve clamping device according to claim 3, wherein the outside and/or inside of the mesh structure is covered with a biocompatible film.5.根据权利要求1所述的贴合充分的瓣膜夹合装置，其特征在于，所述自扩展主体具有与所述调节部的第二端相连的凹陷区，所述凹陷区的末端朝向所述支撑部的第一端延伸至所述调节部的第二端，或者所述凹陷区的末端朝向所述支撑部的第二端延伸至所述调节部的第二端。5. The fully fitted valve clamping device of claim 1, wherein the self-expanding body has a recessed area connected to the second end of the adjustment portion, the end of the recessed area facing the The first end of the support portion extends to the second end of the adjustment portion, or the end of the recessed area extends toward the second end of the support portion to the second end of the adjustment portion.6.根据权利要求5所述的贴合充分的瓣膜夹合装置，其特征在于，还包括固定件，所述调节部的第二端穿装并固定在所述固定件中，以通过所述固定件与所述支撑部固定连接。6. The fully fitted valve clamping device according to claim 5, further comprising a fixing member, and the second end of the adjusting portion is inserted through and fixed in the fixing member, so as to pass through the fixing member. The fixing member is fixedly connected with the supporting portion.7.根据权利要求1所述的贴合充分的瓣膜夹合装置，其特征在于，所述自扩展主体包括依次连接的第一区段、第二区段及第三区段；7. The fully fitted valve clamping device of claim 1, wherein the self-expanding body comprises a first segment, a second segment, and a third segment connected in sequence;所述第一区段自所述调节部的第二端朝向所述支撑部的第二端延伸，且所述第一区段围绕在所述支撑部的第二端的外侧；所述第二区段自所述第一区段继续径向向外延伸；所述第三区段自所述第二区段朝向所述支撑部的第一端同时径向向内延伸至所述调节部的第一端截止。The first section extends from the second end of the adjusting part toward the second end of the supporting part, and the first section surrounds the outside of the second end of the supporting part; the second area The segment continues to extend radially outward from the first segment; the third segment extends radially inward from the second segment toward the first end of the support portion while extending radially inward to the first end of the adjustment portion. One end is cut off.8.根据权利要求7所述的贴合充分的瓣膜夹合装置，其特征在于，所述自扩展主体还包括弯折区段，所述弯折区段连接于所述调节部的第二端与所述第一区段之间。8. The fully fitted valve clamping device of claim 7, wherein the self-expanding body further comprises a curved section connected to the second end of the adjustment portion and the first section.9.根据权利要求7所述的贴合充分的瓣膜夹合装置，其特征在于，所述自扩展主体的第二区段的径向尺寸的范围为4mm-15mm，所述调节部的第一端的径向尺寸的范围为1mm-5mm。9. The adequately fitted valve clamping device according to claim 7, wherein the radial dimension of the second section of the self-expanding body is in the range of 4mm-15mm, the first The radial dimensions of the ends range from 1 mm to 5 mm.10.根据权利要求1至9任一项所述的贴合充分的瓣膜夹合装置，其特征在于，所述瓣膜夹合装置还包括驱动部，所述夹合部包括至少两个钳臂，所述至少两个钳臂相对于所述调节部对称设置，所述驱动部分别与每个所述钳臂连接，以驱动每个所述钳臂靠近或远离所述调节部。10. The fully fitted valve clamping device according to any one of claims 1 to 9, wherein the valve clamping device further comprises a driving part, and the clamping part comprises at least two clamp arms, The at least two clamp arms are symmetrically arranged relative to the adjusting portion, and the driving portion is respectively connected with each of the clamp arms to drive each of the clamp arms to approach or move away from the adjusting portion.11.根据权利要求10所述的贴合充分的瓣膜夹合装置，其特征在于，所述支撑部的第一端设有基座，每一所述钳臂均转动连接于所述基座上，所述支撑部的第一端与所述调节部的第一端之间具有轴向间距。11 . The fully fitted valve clamping device according to claim 10 , wherein the first end of the support portion is provided with a base, and each of the clamp arms is rotatably connected to the base. 12 . , there is an axial distance between the first end of the supporting portion and the first end of the adjusting portion.12.根据权利要求11所述的贴合充分的瓣膜夹合装置，其特征在于，所述驱动部包括：驱动轴、连接座以及至少两个连杆；其中，每个所述连杆的一端与一个所述钳臂转动连接，每个所述连杆的另一端与所述连接座转动连接；所述驱动轴的一端与所述连接座连接，所述驱动轴的另一端活动地穿装在所述基座中。12. The fully fitted valve clamping device according to claim 11, wherein the driving part comprises: a driving shaft, a connecting seat and at least two connecting rods; wherein, one end of each of the connecting rods It is rotatably connected with one of the clamp arms, and the other end of each connecting rod is rotatably connected with the connection seat; one end of the drive shaft is connected with the connection seat, and the other end of the drive shaft is movably fitted in the base.13.根据权利要求12所述的贴合充分的瓣膜夹合装置，其特征在于，所述瓣膜夹合装置还包括设于所述基座中的锁定部，所述锁定部限制所述驱动轴与所述基座的相对运动。13. The fully fitted valve clamping device of claim 12, further comprising a locking portion provided in the base, the locking portion restraining the drive shaft relative movement to the base.14.根据权利要求11所述的贴合充分的瓣膜夹合装置，其特征在于，所述驱动部包括：驱动轴、自动闭合单元以及至少两个连杆；所述驱动轴活动穿装于所述支撑部中，每个所述连杆的一端与一个所述钳臂转动连接，每个所述连杆的另一端与所述驱动轴转动连接；所述自动闭合单元连接所述钳臂，用于使得所述钳臂在自然状态下贴靠所述调节部。14 . The valve clamping device with sufficient fit according to claim 11 , wherein the driving part comprises: a driving shaft, an automatic closing unit and at least two connecting rods; the driving shaft is movably passed through the In the support part, one end of each of the connecting rods is rotatably connected with one of the pliers arms, and the other end of each of the connecting rods is rotatably connected with the drive shaft; the automatic closing unit is connected with the pliers arms, It is used to make the pliers arm abut against the adjusting part in a natural state.15.根据权利要求11所述的贴合充分的瓣膜夹合装置，其特征在于，所述驱动部包括驱动轴以及至少两个弹性驱动臂，所述驱动轴的一端活动穿装于所述支撑部中，每一所述弹性驱动臂的一端均固定连接所述驱动轴的另一端，每一所述弹性驱动臂的另一端分别连接一个所述钳臂；所述弹性驱动臂用于使得所述钳臂在自然状态下贴靠所述调节部。15 . The fully fitted valve clamping device according to claim 11 , wherein the driving part comprises a driving shaft and at least two elastic driving arms, and one end of the driving shaft is movably fitted to the support. 16 . In the part, one end of each elastic drive arm is fixedly connected to the other end of the drive shaft, and the other end of each elastic drive arm is connected to one of the clamp arms; the elastic drive arm is used to make all the The plier arm is pressed against the adjusting portion in a natural state.16.根据权利要求10所述的贴合充分的瓣膜夹合装置，其特征在于，所述钳臂的末端设有翻边段，所述翻边段呈朝向所述钳臂的末端的外侧翻转的弧面，所述钳臂贴靠至所述调节部后，所述自扩展主体在轴向上突出于所述翻边段。16 . The fully fitted valve clamping device according to claim 10 , wherein the distal end of the forceps arm is provided with a flanging segment, and the flanged segment is turned toward the outside of the distal end of the forceps arm. 17 . After the clamp arm is pressed against the adjusting portion, the self-expanding body protrudes from the flange section in the axial direction.17.根据权利要求16所述的贴合充分的瓣膜夹合装置，其特征在于，所述自扩展主体对应所述翻边段处设置适配段，所述适配段朝向所述翻边段的一侧的形状与所述弧面互补。17 . The fully fitted valve clamping device according to claim 16 , wherein the self-expanding body is provided with an adapting segment corresponding to the flanging segment, and the adapting segment faces the flanging segment. 18 . The shape of one side is complementary to the arc surface.18.根据权利要求1至9任一项所述的贴合充分的瓣膜夹合装置，其特征在于，所述瓣膜夹合装置还包括抓持部，所述抓持部设于所述夹合部及所述调节部之间并可相对所述支撑部展开或闭合。18. The adequately fitted valve clamping device according to any one of claims 1 to 9, wherein the valve clamping device further comprises a gripping portion, the gripping portion being provided on the gripping portion The space between the adjusting portion and the adjusting portion can be unfolded or closed relative to the support portion.19.一种瓣膜夹合系统，其特征在于，包括权利要求1至18任一项所述的贴合充分的瓣膜夹合装置、以及输送装置，所述输送装置包括：具有一定轴向长度的推送鞘管及活动地穿装在所述推送鞘管中的芯轴，所述推送鞘管与所述支撑部之间可拆卸连接，所述芯轴用于驱动所述夹合部的展开和闭合。19. A valve clamping system, characterized by comprising the fully fitted valve clamping device according to any one of claims 1 to 18, and a delivery device, the delivery device comprising: a valve having a certain axial length A push sheath tube and a mandrel movably inserted in the push sheath tube, the push sheath tube and the support portion are detachably connected, and the mandrel is used to drive the expansion and expansion of the clamping portion. closure.

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