CN111067667B - Force measuring device and pushing assembly thereof - Google Patents

Abstract

The present invention relates to a push assembly for releasable connection with an apex shim for securing a tether of a heart valve implanted in a heart outside the heart, the push assembly comprising a push housing and an engagement member. The fastener sets up on promoting the shell, and the distal end stretches out the propelling movement shell, and the fastener is used for being connected with the apex of the heart gasket, and the apex of the heart gasket is provided with the fixed orifices that is used for being connected with the fastener, and the distal end of fastener is inserted and is located the fixed orifices, and after the apex of the heart gasket loaded to the fastener, the size of the distal end of fastener was greater than the fixed orifices, and when the fastener released the apex of the heart gasket, the size of the distal end of fastener reduced to breaking away from in following the fixed orifices. Above-mentioned push assembly, apex of the heart gasket can more firmly fix on push assembly to can release from push assembly more conveniently.

Description

Translated fromChinese

测力装置及其推送组件Force measuring device and its push assembly

技术领域technical field

本发明涉及医疗器械领域，特别是涉及一种测力装置及其推送组件。The invention relates to the field of medical instruments, in particular to a force measuring device and a push assembly thereof.

背景技术Background technique

一些已知的假体心脏瓣膜(例如假体二尖瓣)包括一个或多个系绳，系绳从瓣膜延伸到心脏的外部，并且用心尖垫片固定到心脏的外心室壁。通过系绳的约束力，瓣膜在心脏收缩的过程中不会被挤入到心房内，从而降低血液从二尖瓣处反流至心房内的风险。Some known prosthetic heart valves (eg, prosthetic mitral valves) include one or more tethers that extend from the valve to the exterior of the heart and are secured to the outer ventricular wall of the heart with apical spacers. The restraint of the tether prevents the valve from being squeezed into the atrium during systole, thereby reducing the risk of regurgitation of blood from the mitral valve into the atrium.

系绳的张紧程度决定了心脏瓣膜的固定效果。当系绳松弛，心脏瓣膜无法被系绳拉向心尖，当心脏收缩期，心室的血流冲击瓣膜，此时心脏瓣膜会向心房侧移动，从而在原生瓣膜和植入心脏瓣膜之间产生缝隙，从而产生了瓣周漏的现象，使得手术失败。当系绳过度张紧，使得心肌过度被压缩，影响到心脏泵血，严重的话也会使得心肌受损而产生心衰。The degree of tension in the tether determines how well the heart valve is held in place. When the tether is slack, the heart valve cannot be pulled toward the apex by the tether. During systole, blood flow from the ventricle hits the valve, and the heart valve moves toward the atrium, creating a gap between the native valve and the implanted heart valve. , resulting in paravalvular leakage and failure of the operation. When the tether is too tight, the myocardium is over-compressed, affecting the pumping of the heart, and in severe cases, the myocardium is damaged and heart failure occurs.

目前，现有的装置还存在一些问题，例如心尖垫片不能较好地从装置上释放等。At present, the existing devices still have some problems, such as the apical spacer cannot be released from the device well.

发明内容SUMMARY OF THE INVENTION

基于此，针对上述问题，有必要提供一种测力装置及其推送组件。Based on this, in view of the above problems, it is necessary to provide a force measuring device and a push assembly thereof.

一种推送组件，所述推送组件用于与心尖垫片可释放地连接，所述心尖垫片用于将植入到心脏内的心脏瓣膜的系绳固定在心脏外，包括：A push assembly for releasably connecting with an apical spacer for securing a tether of a heart valve implanted in the heart outside the heart, comprising:

推送外壳；push the shell;

接合件，所述接合件设置于所述推动外壳上，且远端伸出所述推送外壳，所述接合件用于与所述心尖垫片连接，所述心尖垫片设置有用于与所述接合件连接的固定孔，所述接合件的远端插设于所述固定孔，当所述心尖垫片装载至所述接合件后，所述接合件的远端的尺寸大于所述固定孔，当所述接合件释放所述心尖垫片时，所述接合件的远端的尺寸减小至从所述固定孔中脱离。an engaging piece, the engaging piece is arranged on the pushing shell, and the distal end extends out of the pushing shell, the engaging piece is used for connecting with the apex spacer, and the apex spacer is provided for connecting with the apex spacer a fixing hole connected by an engaging piece, the distal end of the engaging piece is inserted into the fixing hole, and after the cardiac apex spacer is loaded into the engaging piece, the size of the distal end of the engaging piece is larger than that of the fixing hole , when the engagement member releases the apical spacer, the distal end of the engagement member is reduced in size to disengage from the securing hole.

在其中一个实施例中，所述接合件包括：In one embodiment, the joint includes:

弹性管，所述弹性管固定设置于所述推送外壳，所述弹性管的远端伸出所述推送外壳，且所述弹性管的延伸方向与所述推送外壳的中心轴平行，所述弹性管的远端用于与所述心尖垫片连接；an elastic tube, the elastic tube is fixedly arranged on the push housing, the distal end of the elastic tube extends out of the push housing, and the extension direction of the elastic tube is parallel to the central axis of the push housing, the elastic tube extends the distal end of the tube is used to connect with the apical spacer;

填充芯，所述填充芯可滑动设置于所述弹性管内，当所述填充芯滑动至与所述弹性管的远端齐平时，所述弹性管的远端的尺寸大于所述固定孔，当所述填充芯向近端回撤时，所述弹性管的远端的尺寸减小至从所述固定孔中脱离。A filling core, the filling core can be slidably arranged in the elastic tube, when the filling core slides to be flush with the distal end of the elastic tube, the size of the distal end of the elastic tube is larger than the fixing hole, when As the core is retracted proximally, the distal end of the elastic tube is reduced in size to disengage from the fixation hole.

在其中一个实施例中，所述弹性管的远端周壁上设置有多个缺口。In one embodiment, a plurality of notches are provided on the peripheral wall of the distal end of the elastic tube.

在其中一个实施例中，所述接合件还包括：In one of the embodiments, the joint further includes:

推送块，所述推送块滑动设置于所述推送外壳，所述填充芯固定设置于所述推送块，且所述填充芯的远端伸出所述推送块。A push block, the push block is slidably arranged on the push shell, the filling core is fixedly arranged on the push block, and the distal end of the filling core extends out of the push block.

在其中一个实施例中，所述推动外壳内设置有弹簧，所述推送块与所述弹簧连接。In one of the embodiments, a spring is provided in the push housing, and the push block is connected with the spring.

在其中一个实施例中，所述推送块的远端与所述弹簧的近端抵接。In one embodiment, the distal end of the push block abuts the proximal end of the spring.

在其中一个实施例中，所述推送外壳的侧壁设置有滑轨，所述推送块滑动设置于所述滑轨内。In one embodiment, a sliding rail is provided on the side wall of the pushing housing, and the pushing block is slidably arranged in the sliding rail.

在其中一个实施例中，所述弹性管及所述填充芯的数量均为2个。In one embodiment, the number of the elastic tubes and the filling cores are both two.

在其中一个实施例中，所述固定孔为盲孔。In one of the embodiments, the fixing holes are blind holes.

一种测力装置，包括上述任一所述的推送组件。A force measuring device, comprising any of the above-mentioned pushing components.

上述测力装置及其推送组件，当心尖垫片装载至接合件后，接合件的远端的尺寸大于固定孔，当接合件释放心尖垫片时，接合件的远端的尺寸减小至从固定孔中脱离，心尖垫片能够较牢固地固定在测力装置上，并且可以较方便地从测力装置上释放。The above-mentioned force measuring device and its pushing assembly, when the apical gasket is loaded into the joint, the size of the distal end of the joint is larger than the fixing hole, and when the joint releases the apex gasket, the size of the distal end of the joint is reduced to from If it is disengaged from the fixing hole, the cardiac apex gasket can be firmly fixed on the force measuring device, and can be released from the force measuring device more conveniently.

附图说明Description of drawings

图1为本申请一实施例的心脏瓣膜植入心脏后的结构示意图；1 is a schematic structural diagram of a heart valve after implantation into a heart according to an embodiment of the application;

图2为本申请第一实施例的测力装置的结构示意图；2 is a schematic structural diagram of the force measuring device according to the first embodiment of the application;

图3为图2所示的测力装置的推送组件的局部剖切图；Figure 3 is a partial cutaway view of the push assembly of the force measuring device shown in Figure 2;

图4为图2所示的测力装置的推送组件的剖视图；Fig. 4 is a sectional view of the push assembly of the force measuring device shown in Fig. 2;

图5为图1所示的心尖垫片的结构示意图；FIG. 5 is a schematic structural diagram of the apical spacer shown in FIG. 1;

图6为图2所示的测力装置与心尖垫片组装后的局部剖切图；FIG. 6 is a partial cutaway view of the force measuring device shown in FIG. 2 and the apical gasket after being assembled;

图7为图2所示的测力装置的局部剖切图；Figure 7 is a partial cutaway view of the force measuring device shown in Figure 2;

图8为图2所示的测力装置在一状态下的局部剖切图；Fig. 8 is a partial cutaway view of the force measuring device shown in Fig. 2 in a state;

图9为图2所示的测力装置在另一状态下的局部剖切图；Fig. 9 is a partial cutaway view of the force measuring device shown in Fig. 2 in another state;

图10为图2所示的测力装置的系绳锁定件与系绳连接后的结构示意图；FIG. 10 is a schematic structural diagram of the tether locking member of the force measuring device shown in FIG. 2 after being connected to the tether;

图11为图2所示的测力装置的系绳锁定件的爆炸图；Figure 11 is an exploded view of the tether lock of the force measuring device shown in Figure 2;

图12为本申请第二实施例的测力装置的结构示意图；12 is a schematic structural diagram of a force measuring device according to the second embodiment of the application;

图13为图12所示的测力装置与系绳连接后在一种状态下的局部剖切图；Fig. 13 is a partial cutaway view of the force measuring device shown in Fig. 12 in one state after being connected to the tether;

图14为图12所示的测力装置与系绳连接后在另一状态下的局部剖切图；Figure 14 is a partial cutaway view of the force measuring device shown in Figure 12 in another state after being connected to the tether;

图15为本申请第三实施例的测力装置的结构示意图；15 is a schematic structural diagram of a force measuring device according to a third embodiment of the application;

图16为图15所示的测力装置的局部剖切图；Figure 16 is a partial cutaway view of the force measuring device shown in Figure 15;

图17为图15所示的测力装置的局部剖切后的爆炸图；Figure 17 is an exploded view of the force measuring device shown in Figure 15 after a partial cut;

图18为图15所示的测力装置与系绳连接后的局部剖切图。FIG. 18 is a partial cutaway view of the force measuring device shown in FIG. 15 after being connected to the tether.

具体实施方式Detailed ways

为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。In order to make the above objects, features and advantages of the present invention more clearly understood, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific implementation disclosed below.

需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or an intervening element may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for the purpose of illustration only and do not represent the only embodiment.

除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

在本申请中，“远端”和"近端"分别指的是更远离和更靠近例如医疗装置的操作者的方向。因此，例如，最靠近患者身体(例如，接触患者的身体或者布置在患者的身体内)的医疗装置的一端为该医疗装置的远端，与远端相对并且例如最靠近医疗装置的使用者(或使用者的手)的一端为医疗装置的近端。In this application, "distal" and "proximal" refer to directions further away and closer to the operator of eg a medical device, respectively. Thus, for example, the end of a medical device that is closest to (eg, contacts or is disposed within) a patient's body is the distal end of the medical device, opposite the distal end and, for example, closest to a user of the medical device ( or the user's hand) is the proximal end of the medical device.

图1是本申请一实施例的心脏瓣膜植入心脏后的结构示意图。心脏瓣膜包括瓣膜支架11、系绳12及心尖垫片13，系绳12的一端与瓣膜支架11固定，另一端与心尖垫片13连接。当心脏瓣膜植入后，瓣膜支架11卡在二尖瓣环处，系绳12伸出心脏外与心尖垫片13固定。心尖垫片13位于心脏外侧的心尖处，可以起到拉紧系绳12，确保心脏瓣膜固定在合适的位置上，还可以起到封堵输送过程中在心尖位置的路入通道的作用。FIG. 1 is a schematic structural diagram of a heart valve after implantation into a heart according to an embodiment of the present application. The heart valve includes avalve support 11 , atether 12 and anapex spacer 13 . One end of thetether 12 is fixed to thevalve support 11 , and the other end is connected to theapex spacer 13 . After the heart valve is implanted, thevalve support 11 is stuck at the mitral valve annulus, and thetether 12 is extended out of the heart and fixed to theapical spacer 13 . Theapex spacer 13 is located at the apex outside the heart, which can tighten thetether 12 to ensure that the heart valve is fixed in a proper position, and can also block the access channel at the apex during the delivery process.

在植入心脏瓣膜时，当心脏瓣膜从输送鞘管中释放后，撤出输送鞘管，系绳12伸出心脏外，此时将测力装置10与心尖垫片13固定，同时将系绳穿过心尖垫片13，并与测力装置10锚定，调节测力装置10，以使系绳12被牵引/牵拉到合适张力如通过超声或者DSA(数字减影血管造影)等检测无瓣周漏的存在时，锁定系绳12的长度，在该张力时将系绳12固定在心尖垫片13上。When the heart valve is implanted, after the heart valve is released from the delivery sheath, the delivery sheath is withdrawn, and thetether 12 extends out of the heart. At this time, theforce measuring device 10 and theapex spacer 13 are fixed, and the tether is fixed at the same time. Through theapical spacer 13 and anchored with theforce measuring device 10, theforce measuring device 10 is adjusted so that thetether 12 is pulled/pulled to the proper tension as detected by ultrasound or DSA (Digital Subtraction Angiography) etc. In the presence of a paravalvular leak, the length of thetether 12 is locked, securing thetether 12 to theapical spacer 13 at this tension.

请参阅图2，本申请第一实施例的测力装置10包括壳体100、推送组件200及测力组件300，推送组件200位于壳体100的远端，测力组件100设置于壳体100。Referring to FIG. 2 , theforce measuring device 10 according to the first embodiment of the present application includes acasing 100 , apush assembly 200 and aforce measuring assembly 300 . Thepush assembly 200 is located at the distal end of thecasing 100 , and theforce measuring assembly 100 is disposed on thecasing 100 .

在一实施例中，壳体100与推送组件200固定连接。具体的，壳体100与推送组件200通过铆接固定连接，可以避免使用螺钉，拆装更加方便。In one embodiment, thehousing 100 is fixedly connected with thepush assembly 200 . Specifically, thehousing 100 and thepush assembly 200 are fixedly connected by riveting, which can avoid the use of screws and make disassembly and assembly more convenient.

请一并参阅图3、图4及图6，推送组件200用于与心尖垫片13可释放地连接。推送组件200包括推送外壳210及接合件220，接合件220设置于推送外壳210上，且接合件220的外端伸出推送外壳210。推送外壳210与壳体固定连接。在本实施例中，推动外壳210与壳体100通过铆接固定连接。接合件220用于与心尖垫片13连接，心尖垫片13上设置有用于与接合件210连接的固定孔13a，接合件220的远端插设于固定孔13a，当心尖垫片13装载至接合件220后，接合件220的远端的尺寸大于固定孔13a，当接合件220释放心尖垫片13时，接合件220的远端的尺寸减小至从固定孔13a中脱离。Please refer to FIG. 3 , FIG. 4 and FIG. 6 together, the pushingassembly 200 is used for releasably connecting with theapical spacer 13 . The pushingassembly 200 includes a pushinghousing 210 and anengaging piece 220 , the engagingpiece 220 is disposed on the pushinghousing 210 , and the outer end of theengaging piece 220 protrudes out of the pushinghousing 210 . Thepush housing 210 is fixedly connected to the housing. In this embodiment, thepush housing 210 and thehousing 100 are fixedly connected by riveting. Thejoint piece 220 is used for connecting with theapex spacer 13. Theapex gasket 13 is provided with a fixinghole 13a for connecting with thejoint piece 210. The distal end of thejoint piece 220 is inserted into the fixinghole 13a. After engaging themember 220, the size of the distal end of the engagingmember 220 is larger than that of the fixinghole 13a. When the engagingmember 220 releases theapical spacer 13, the size of the distal end of the engagingmember 220 is reduced to disengage from the fixinghole 13a.

接合件220包括弹性管221及填充芯222，填充芯222的远端穿设于弹性管221，填充芯222滑动设置于弹性管221内。弹性管221固定设置于推送外壳210，且远端伸出推送外壳210，弹性管221的延伸方向与推送外壳210的中心轴平行，弹性管221的远端用于与心尖垫片13连接。当弹性管221的远端插设于心尖垫片13的固定孔13a时，弹性管221与心尖垫片13垂直连接，心尖垫片13与系绳12的延伸方向垂直，可以避免在手术过程中调整系绳12与心尖垫片13之间的夹角，降低手术难度，而且可以有助于提高后续对系绳12的张力值测定的准确性。The joint 220 includes anelastic tube 221 and a fillingcore 222 . The distal end of the fillingcore 222 is inserted through theelastic tube 221 , and the fillingcore 222 is slidably disposed in theelastic tube 221 . Theelastic tube 221 is fixed on thepush housing 210 , and the distal end extends out of thepush housing 210 . The extension direction of theelastic tube 221 is parallel to the central axis of thepush housing 210 . When the distal end of theelastic tube 221 is inserted into the fixinghole 13a of theapex spacer 13, theelastic tube 221 is vertically connected to theapex spacer 13, and theapex spacer 13 is perpendicular to the extension direction of thetether 12, which can avoid the need for operation during the operation. Adjusting the angle between thetether 12 and theapex spacer 13 reduces the difficulty of the operation, and can help to improve the accuracy of the subsequent measurement of the tension value of thetether 12 .

在一实施例中，弹性管221为中空管，弹性管221的内径略大于填充芯222的外径，且在自然状态下，弹性管221的远端的最大外径大于固定孔13a的直径。填充芯222与弹性管221同轴设置。当填充芯222滑动至与弹性管221的远端齐平时，弹性管221的远端被撑开，弹性管221的远端直径大于固定孔13a，产生过盈配合，以将心尖垫片13固定在弹性管221的远端。当填充芯222向近端回撤时，弹性管221的远端直径变小至从固定孔13a中脱离，以将心尖垫片13从测力装置10上释放。在图示的实施例中，弹性管221的远端的直径略大于近端的直径。In one embodiment, theelastic tube 221 is a hollow tube, the inner diameter of theelastic tube 221 is slightly larger than the outer diameter of the fillingcore 222, and in a natural state, the maximum outer diameter of the distal end of theelastic tube 221 is larger than the diameter of the fixinghole 13a . The fillingcore 222 is arranged coaxially with theelastic tube 221 . When the fillingcore 222 slides to be flush with the distal end of theelastic tube 221, the distal end of theelastic tube 221 is stretched, and the diameter of the distal end of theelastic tube 221 is larger than that of the fixinghole 13a, resulting in an interference fit to fix theapex gasket 13 at the distal end of theelastic tube 221 . When the fillingcore 222 is retracted proximally, the distal end of theelastic tube 221 is reduced in diameter to disengage from thefixation hole 13a to release theapical spacer 13 from theforce measuring device 10 . In the illustrated embodiment, the diameter of the distal end of theelastic tube 221 is slightly larger than the diameter of the proximal end.

在一实施例中，弹性管221的远端周壁上设置有多个缺口2211，缺口2211从弹性管221远离推送外壳210的一端开始并沿弹性管221的轴向方向延伸。通过设置缺口2211，弹性管221的远端插入到固定孔13a时，固定孔13a的孔壁会挤压弹性管221的远端，使得弹性管221的远端的最大外径减小。在一实施例中，缺口2211的数量为2-4个，多个缺口2211沿弹性管221的周向均匀分布。In one embodiment, a plurality ofnotches 2211 are provided on the peripheral wall of the distal end of theelastic tube 221 . By providing thenotch 2211, when the distal end of theelastic tube 221 is inserted into the fixinghole 13a, the hole wall of the fixinghole 13a will press the distal end of theelastic tube 221, so that the maximum outer diameter of the distal end of theelastic tube 221 is reduced. In one embodiment, the number of thenotches 2211 is 2-4, and the plurality ofnotches 2211 are evenly distributed along the circumferential direction of theelastic tube 221 .

请参阅图4，接合件220还包括推送块223，推送块223滑动设置于推送外壳210，填充芯222固定设置于推送块223，且填充芯222的远端伸出推送块223。在一实施例中，推送外壳210的侧壁上设置有滑轨211，推送块223滑动设置于滑轨223内。当推送块223沿着滑轨211轴向时，带动填充芯222在弹性管221内腔内轴向移动。Referring to FIG. 4 , the engagingmember 220 further includes apush block 223 , thepush block 223 is slidably disposed on thepush shell 210 , the fillingcore 222 is fixedly disposed on thepush block 223 , and the distal end of the fillingcore 222 protrudes from thepush block 223 . In one embodiment, aslide rail 211 is disposed on the side wall of thepush housing 210 , and thepush block 223 is slidably disposed in theslide rail 223 . When the pushingblock 223 moves along the axial direction of theslide rail 211 , the fillingcore 222 is driven to move axially in the inner cavity of theelastic tube 221 .

请一并参阅图4，推送外壳210内还设置有弹簧213，推送块223与弹簧连接。弹簧213设置于推送外壳210近端的位置，推送块223的远端与弹簧213的近端抵接。在自然状态下，推送块223位于滑轨211的远端，填充芯222的远端处于弹性管221的远端，如填充芯222的远端与弹性管221的远端齐平或稍超出弹性管221的远端。请一并参阅图6，当需要与心尖垫片13连接时，将推送块223沿滑轨211向近端移动，弹簧213被压缩，填充芯222的远端离开弹性管221的远端，弹性管221的远端插入到心尖垫片13的固定孔13a，此时松开推送块223，在弹簧213的作用下，推送块回复到滑轨211的近端，填充芯222的远端回复到弹性管221的远端将弹性管221的远端撑开，弹性管221的远端与固定孔13a产生过盈配合以将心尖垫片固定在弹性管221的远端。释放时，向近端拉动推送块223，填充芯222的远端再次离开弹性管221的远端，弹性管221的远端直径变小，心尖垫片13的固定孔13a从弹性管221的远端脱离。上述推送组件200，可以防止输送过程中心尖垫片13从测力装置10上脱落，而且还可以避免在释放过程中心尖垫片13无法从测力装置10上脱离。在本实施例中，弹簧213位于推送外壳210的中轴线上。Please also refer to FIG. 4 , aspring 213 is also disposed in thepush housing 210 , and thepush block 223 is connected with the spring. Thespring 213 is disposed at a position where the proximal end of thehousing 210 is pushed, and the distal end of the pushingblock 223 abuts against the proximal end of thespring 213 . In the natural state, the pushingblock 223 is located at the distal end of the slidingrail 211, and the distal end of the fillingcore 222 is located at the distal end of theelastic tube 221, for example, the distal end of the fillingcore 222 is flush with the distal end of theelastic tube 221 or slightly exceeds the elasticity the distal end of thetube 221 . Please also refer to FIG. 6 , when theapex spacer 13 needs to be connected, thepush block 223 is moved proximally along theslide rail 211 , thespring 213 is compressed, the distal end of the fillingcore 222 is separated from the distal end of theelastic tube 221 , and the elastic The distal end of thetube 221 is inserted into the fixinghole 13a of theapex spacer 13. At this time, thepush block 223 is released. Under the action of thespring 213, the push block returns to the proximal end of theslide rail 211, and the distal end of the fillingcore 222 returns to The distal end of theelastic tube 221 stretches the distal end of theelastic tube 221 , and the distal end of theelastic tube 221 produces an interference fit with the fixinghole 13 a to fix the apical gasket on the distal end of theelastic tube 221 . When releasing, pull thepush block 223 toward the proximal end, the distal end of the fillingcore 222 leaves the distal end of theelastic tube 221 again, the diameter of the distal end of theelastic tube 221 becomes smaller, and the fixinghole 13a of theapex gasket 13 is removed from the distal end of theelastic tube 221 . end disengaged. Theabove push assembly 200 can prevent thecenter tip washer 13 from falling off theforce measuring device 10 during the conveying process, and can also prevent thecenter tip washer 13 from being detached from theforce measuring device 10 during the releasing process. In this embodiment, thespring 213 is located on the central axis of thepush housing 210 .

请一并参阅图5及图6，在一实施例中，心尖垫片13设置有两个固定孔13a及用于供系绳12穿过的中心孔13b，两个固定孔13a对称设置于中心孔13b的两侧。固定孔13a为盲孔，中心孔13b为通孔。弹性管221及填充芯222的数量也均为2个，每一弹性管221对应连接一个固定孔13a。Please refer to FIG. 5 and FIG. 6 together. In one embodiment, theapex spacer 13 is provided with two fixingholes 13a and acentral hole 13b for thetether 12 to pass through. The two fixingholes 13a are symmetrically arranged in the center Both sides of thehole 13b. The fixinghole 13a is a blind hole, and thecentral hole 13b is a through hole. There are also twoelastic tubes 221 and two fillingcores 222 , and eachelastic tube 221 is connected to one fixinghole 13 a correspondingly.

请一并参阅图7至图9，测力组件300包括调节螺杆310及滑动设置于调节螺杆310内的系绳调节件320，所述系绳12依次穿过心尖垫片13、推送组件200、壳体100及调节螺杆310，并从系绳调节件320穿出，调节螺杆310的远端可活动设置于壳体100内，调节螺杆310相对于壳体100向近端移动以带动系绳调节件320向近端移动，此时穿过系绳调节件320的系绳12拉动系绳调节件320向远端移动以调节和测定穿过系绳调节件320的系绳12的张力。Please refer to FIG. 7 to FIG. 9 together. Theforce measuring assembly 300 includes an adjustingscrew 310 and atether adjusting member 320 slidably disposed in the adjustingscrew 310. Thetether 12 passes through theapex spacer 13, the pushingassembly 200, Thehousing 100 and the adjustingscrew 310 pass through thetether adjusting member 320. The distal end of the adjustingscrew 310 is movably disposed in thehousing 100, and the adjustingscrew 310 moves proximally relative to thehousing 100 to drive the tether to adjust Thetether 320 is moved proximally, as thetether 12 passing through thetether adjustment member 320 pulls thetether adjustment member 320 distally to adjust and measure the tension of thetether 12 passing through thetether adjustment member 320.

请参阅图2，壳体100的外侧设置有防滑条纹，便于操作者握住。在一实施例中，壳体100内壁设置有内螺纹101，调节螺杆310的远端设置有与内螺纹101匹配的外螺纹311，调节螺杆310与壳体100通过外螺纹311与内螺纹301连接。当旋转调节螺杆310，调节螺杆310会相对于壳体100向近端或远端移动。Please refer to FIG. 2 , the outer side of thehousing 100 is provided with anti-slip strips, which is convenient for the operator to hold. In one embodiment, the inner wall of thehousing 100 is provided with aninternal thread 101 , the distal end of the adjustingscrew 310 is provided with anexternal thread 311 matching theinternal thread 101 , and the adjustingscrew 310 and thehousing 100 are connected with the internal thread 301 through theexternal thread 311 . . When theadjustment screw 310 is rotated, theadjustment screw 310 moves proximally or distally relative to thehousing 100 .

调节螺杆310为中空结构，系绳调节件320滑动设置于调节螺杆310的空腔中。调节螺杆310还设置有弹性件313，系绳调节件320与弹性件313连接。The adjustingscrew 310 is a hollow structure, and thetether adjusting member 320 is slidably disposed in the cavity of the adjustingscrew 310 . The adjustingscrew 310 is also provided with anelastic member 313 , and thetether adjusting member 320 is connected with theelastic member 313 .

在一实施例中，系绳调节件320包括滑动轴321、穿设于滑动轴321内的系绳收容管322及设置于滑动轴321远端的系绳锁定件323。滑动轴321套设在系绳收容件322上，且滑动轴321与系绳收容件322之间可以轴向滑动。系绳12依次穿过系绳收容管322、滑动轴321，最后从系绳锁定件323穿出。In one embodiment, thetether adjusting member 320 includes a slidingshaft 321 , a tetheraccommodating tube 322 passing through the slidingshaft 321 , and atether locking member 323 disposed at the distal end of the slidingshaft 321 . The slidingshaft 321 is sleeved on thetether accommodating member 322 , and the slidingshaft 321 and thetether accommodating member 322 can slide axially. Thetether 12 passes through thetether accommodating tube 322 and the slidingshaft 321 in sequence, and finally passes through thetether locking member 323 .

需要说明的是，系绳收容管322的近端可以与滑动轴321齐平，此时，系绳12只需要穿过系绳收容管322并从系绳锁定件323穿出。It should be noted that the proximal end of thetether accommodating tube 322 may be flush with the slidingshaft 321 , and at this time, thetether 12 only needs to pass through thetether accommodating tube 322 and out from thetether locking member 323 .

滑动轴321的近端滑动设置于调节螺杆310内，且滑动轴321的远端与弹性件313的近端固定连接，弹性件321套设于系绳收容管322。当滑动轴321向近端移动时，弹性件313被压缩。滑动轴321上设置有刻度(图未标)，滑动轴321与调节螺杆310之间的相对位置会通过刻度显示出拉力值。The proximal end of the slidingshaft 321 is slidably disposed in the adjustingscrew 310 , and the distal end of the slidingshaft 321 is fixedly connected to the proximal end of theelastic member 313 , and theelastic member 321 is sleeved on thetether receiving tube 322 . When the slidingshaft 321 moves toward the proximal end, theelastic member 313 is compressed. The slidingshaft 321 is provided with a scale (not marked in the figure), and the relative position between the slidingshaft 321 and the adjustingscrew 310 will display the tension value through the scale.

在一实施例中，调节螺杆310的近端设置有限位结构314以将滑动轴321的远端限定在调节螺杆310内。具体的，调节螺杆310的近端的内径小于滑动轴321的远端的外径，滑动轴321的远端不能从调节螺杆310的近端脱离，防止操作过程中滑动轴321从调节螺杆310内脱离。In one embodiment, the proximal end of the adjustingscrew 310 is provided with a limiting structure 314 to limit the distal end of the slidingshaft 321 within the adjustingscrew 310 . Specifically, the inner diameter of the proximal end of theadjustment screw 310 is smaller than the outer diameter of the distal end of the slidingshaft 321, and the distal end of the slidingshaft 321 cannot be detached from the proximal end of theadjustment screw 310 to prevent the slidingshaft 321 from slipping out of theadjustment screw 310 during operation. break away.

在一实施例中，系绳收容管322为中空管，用于收容系绳12。系绳收容管322贯通滑动轴313、调节螺杆310、壳体100，并延伸至推送组件200，系绳12通过系绳收容管322穿设推送组件200、壳体100及调节螺杆310。在本实施例中，系绳收容管322可以为镍钛管、钢管或其他金属管等，也可以为塑料等非金属管。In one embodiment, thetether accommodating tube 322 is a hollow tube for accommodating thetether 12 . The tetheraccommodating tube 322 passes through the slidingshaft 313 , the adjustingscrew 310 , and thehousing 100 , and extends to thepush assembly 200 . In this embodiment, thetether accommodating tube 322 may be a nickel-titanium tube, a steel tube or other metal tube, etc., or a non-metallic tube such as plastic.

系绳锁定件323用于将系绳12夹紧。请一并参阅10及图11，系绳锁定件323包括底座3231、夹头3232及压盖3233，底座3231与滑动轴321的远端连接，底座3231与压盖3233螺纹连接，夹头3232设置于底座3231与压盖3233之间，底座3231、夹头3232及压盖3233均设置供系绳12穿过的通孔3234，系绳12从底座3231、夹头3232及压盖3233的通孔3234穿出，当压盖3233与底座3231旋紧时，夹头3232的通孔3234的内径减小以将系绳12夹紧。具体的，底座3231上设置有外螺纹，压盖3233为中空结构，内侧具有斜面，且内表面具有与底座3231的外螺纹匹配的内螺纹。夹头3232为管状结构，周壁上设置有开槽，当压盖3233与底座3231旋紧时会挤压位于压盖3233与底座3231之间的夹头3232，使夹头3232的内径减小，此时系绳12被夹头3232夹紧。Tether lock 323 is used to clamptether 12. Please refer to 10 and FIG. 11 together, thetether locking member 323 includes abase 3231, acollet 3232 and agland 3233, thebase 3231 is connected to the distal end of the slidingshaft 321, thebase 3231 is screwed to thegland 3233, and thecollet 3232 is provided Between thebase 3231 and thegland 3233, thebase 3231, theclip 3232 and thegland 3233 are all provided with a throughhole 3234 for thetether 12 to pass through. When thecap 3233 is screwed with thebase 3231, the inner diameter of the throughhole 3234 of thecollet 3232 is reduced to clamp thetether 12. Specifically, thebase 3231 is provided with an external thread, thegland 3233 is a hollow structure, the inner side has a slope, and the inner surface has an internal thread matching the external thread of thebase 3231 . Thecollet 3232 is a tubular structure, and the peripheral wall is provided with a slot. When thegland 3233 and thebase 3231 are tightened, thecollet 3232 located between thegland 3233 and thebase 3231 will be squeezed, so that the inner diameter of thecollet 3232 is reduced. Thetether 12 is now clamped by thecollet 3232.

请参阅图8，在自然状态下，将系绳12穿过系绳收容管322、滑动轴313，并通过系绳锁定件323穿出，将系绳12保持拉直的状态，并通过系绳锁定件323固定系绳12的长度，此时调节螺杆310的远端位于壳体100靠远端的位置，滑动轴321的远端位于调节螺杆310靠近近端的位置，弹性件313处于自然伸展状态。请一并参阅图9，旋转调节螺杆310使调节螺杆310向壳体100的近端移动，调节螺杆310的移动会整体带动与调节螺杆310连接的滑动轴321及系绳锁定件323向近端移动，由于系绳12的长度被固定，此时系绳12会拉动滑动轴321向远端移动，使弹性件313被压缩，滑动轴移动321移动的距离即弹簧被压缩的长度，根据胡克定律，由此可以得出系绳12的张力值。Referring to FIG. 8 , in the natural state, thetether 12 is passed through thetether accommodating tube 322 and the slidingshaft 313, and is passed through thetether locking member 323, so that thetether 12 is kept in a straight state, and thetether 12 is in a straight state. The lockingmember 323 fixes the length of thetether 12. At this time, the distal end of theadjustment screw 310 is located at the distal end of thehousing 100, the distal end of the slidingshaft 321 is located at the proximal end of theadjustment screw 310, and theelastic member 313 is in a natural stretch. state. Please also refer to FIG. 9 , the adjustingscrew 310 is rotated to move the adjustingscrew 310 toward the proximal end of thehousing 100 , and the movement of the adjustingscrew 310 will integrally drive the slidingshaft 321 and thetether locking member 323 connected with the adjustingscrew 310 to the proximal end. Since the length of thetether 12 is fixed, thetether 12 will pull the slidingshaft 321 to move to the distal end, so that theelastic member 313 is compressed, and the distance that the sliding shaft moves 321 is the length of the compressed spring. law, from which the value of the tension of thetether 12 can be derived.

使用时，将系绳12从心尖垫片13的中心孔13b穿出后，依次通过系绳收容管322、滑动轴313，并通过系绳锁定件323穿出；后撤推送块223，将弹簧管221的远端插设到心尖垫片13的固定孔13a，松开推送块223，以使心尖垫片13固定在弹性管221上，并将心尖垫片13输送至贴近心尖的位置；拉动系绳12，以使系绳12向近端拉直，即系绳12无打折弯曲等情况，通过系绳锁定件323锁定系绳12的长度；旋转调节螺杆310，以使调节螺杆310相对于壳体100向近端移动带动滑动轴321向近端移动，此时系绳12会拉动滑动轴321向远端移动，以压缩弹性件313，系绳12的力值显示在调节螺杆310的近端端面指向在滑动轴321外侧的数值。当调节螺杆310旋转至使系绳12达到合适的张力值，例如在超声检查下无瓣周漏的发生，将系绳12固定在心尖垫片13上，并撤去测力装置10。当然，在一实施例中，当调节好系绳12的张力值后，也可以先撤去测力装置10，再将系绳12固定在心尖垫片13上。In use, after passing thetether 12 from thecentral hole 13b of theapex spacer 13, it passes through thetether accommodating tube 322, the slidingshaft 313, and thetether locking piece 323 in sequence; The distal end of thetube 221 is inserted into the fixinghole 13a of theapex spacer 13, and thepush block 223 is released to fix theapex spacer 13 on theelastic tube 221, and theapex spacer 13 is transported to a position close to the apex;Tether 12, so that thetether 12 is straightened proximally, that is, thetether 12 is not bent or bent, and the length of thetether 12 is locked by thetether locking member 323; The proximal movement of thehousing 100 drives the slidingshaft 321 to move proximally, and thetether 12 will pull the slidingshaft 321 to move distally to compress theelastic member 313 . The end face points to the value outside the slidingshaft 321 . When the adjustingscrew 310 is rotated to make thetether 12 reach a suitable tension value, for example, no paravalvular leakage occurs under ultrasound examination, thetether 12 is fixed on theapical spacer 13, and theforce measuring device 10 is removed. Of course, in an embodiment, after the tension value of thetether 12 is adjusted, theforce measuring device 10 can also be removed first, and then thetether 12 can be fixed on theapex spacer 13 .

请参阅图12至图14，本申请第二实施例的测力装置40包括手柄组件400、推送组件500、测力组件600，推送组件500位于手柄组件400的远端，测力组件500设置于手柄组件400。12 to 14 , theforce measuring device 40 according to the second embodiment of the present application includes ahandle assembly 400 , apush assembly 500 , and aforce measuring assembly 600 . Thepush assembly 500 is located at the distal end of thehandle assembly 400 , and theforce measuring assembly 500 is disposed at theHandle assembly 400.

在一实施例中，手柄组件400包括壳体410及设置于壳体410远离推送组件一端的系绳锁定件420。壳体410包括上壳体(图未标，与上壳体411对称设置)及下壳体411，上壳体与下壳体411通过铆合固定连接。系绳锁定件420卡合在壳体410的远端。In one embodiment, thehandle assembly 400 includes ahousing 410 and atether locking member 420 disposed at one end of thehousing 410 away from the push assembly. Thecasing 410 includes an upper casing (not shown, which is symmetrically arranged with the upper casing 411 ) and a lower casing 411 , and the upper casing and the lower casing 411 are fixedly connected by riveting. Thetether lock 420 snaps onto the distal end of thehousing 410 .

在一实施例中，壳体410的外表面设置有凸纹，便于操作者抓握，防止使用时打滑。In one embodiment, the outer surface of thecasing 410 is provided with raised lines, which are convenient for the operator to grasp and prevent slipping during use.

系绳锁定件420用于将系绳12夹紧。系绳锁定件420具体结构可以参照实施例一中的系绳锁定件323，在此不再赘述。在本实施例中，系绳锁定件420的底座卡合在壳体410内。Tether lock 420 is used to clamptether 12. For the specific structure of thetether locking member 420, reference may be made to the tethered lockingmember 323 in the first embodiment, which will not be repeated here. In this embodiment, the base of thetether locking member 420 is engaged in thehousing 410 .

推送组件500用于与心尖垫片13可释放地连接。推送组件500的具体结构可参照实施例一中的推送组件200，在此不再赘述。Thepusher assembly 500 is used for releasable connection with theapical spacer 13 . For the specific structure of thepush component 500, reference may be made to thepush component 200 in the first embodiment, which will not be repeated here.

测力组件600分别穿设推送组件500及手柄组件400，测力组件600设置有供系绳12穿过的系绳通道601，系绳12依次穿过心尖垫片13、推送组件500、系绳通道601，并从手柄组件400穿出，手柄组件400可相对于测力组件600轴向运动以调节和测定延伸穿过系绳通道601及手柄组件400的系绳12的张力。Theforce measuring assembly 600 passes through thepush assembly 500 and thehandle assembly 400 respectively. Theforce measuring assembly 600 is provided with atether channel 601 for thetether 12 to pass through.Passageway 601 and extending fromhandle assembly 400, handleassembly 400 is axially movable relative to loadcell assembly 600 to adjust and measure the tension oftether 12 extending throughtether passageway 601 and handleassembly 400.

需要说明的是，测力组件600的系绳通道601可延伸至推送组件500的远端，系绳601通过系绳通道601穿设推送组件500。It should be noted that thetether channel 601 of theforce measuring assembly 600 may extend to the distal end of thepush assembly 500 , and thetether 601 passes through thepush assembly 500 through thetether channel 601 .

在一实施例中，测力组件600包括固定杆610及套设于固定杆610上的弹性件620。固定杆610上设置有系绳通道601，弹性件620收容于壳体410内，壳体410可相对于固定杆610轴向运动。在一实施例中，固定杆610位于壳体410的中轴线上，固定杆610的近端收容于壳体410内，弹性件620位于壳体410的远端与固定杆610的近端之间。In one embodiment, theforce measuring assembly 600 includes a fixingrod 610 and anelastic member 620 sleeved on the fixingrod 610 . The fixingrod 610 is provided with atether channel 601 , theelastic member 620 is accommodated in thehousing 410 , and thehousing 410 can move axially relative to the fixingrod 610 . In one embodiment, the fixingrod 610 is located on the central axis of thehousing 410 , the proximal end of the fixingrod 610 is accommodated in thehousing 410 , and theelastic member 620 is located between the distal end of thehousing 410 and the proximal end of the fixingrod 610 . .

固定杆610与推送组件500固定连接。固定杆610可延伸至推送组件500的远端。固定杆610为中空管状结构，腔体为供系绳12穿过的系绳通道601。固定杆610可以包括金属管及包裹在金属管外的塑料管，金属管延伸至推送组件500的端部，塑料管结构可仅延伸至与推送组件500的近端固定连接。The fixingrod 610 is fixedly connected with the pushingassembly 500 . Thefixation rod 610 may extend to the distal end of thepush assembly 500 . The fixingrod 610 is a hollow tubular structure, and the cavity is atether channel 601 for thetether 12 to pass through. The fixingrod 610 may include a metal tube and a plastic tube wrapped around the metal tube. The metal tube extends to the end of thepush assembly 500 , and the plastic tube structure may only extend to the proximal end of thepush assembly 500 to be fixedly connected.

请一并参阅图13及图14，壳体410的内壁设置有多个平行设置的凹槽413，固定杆610上设置有止挡件613，弹性件620位于止挡件613的远端与壳体410的远端之间，止挡件613可相对于壳体410转动，当止挡件613转动至卡合在凹槽413内，壳体410相对于固定杆610的位置固定，即壳体410不能相对于固定杆610轴向移动。具体的，止挡件613为凸设于固定杆610表面的凸块，凸块与凹槽413相匹配。请参阅图13，当凸块在水平状态时，即凸块与凹槽413深度方向呈90°时，壳体410可相对于固定杆610轴向运动。请参阅图14，将固定杆610转动90°，凸块与凹槽413卡合，壳体410与固定杆610之间不再发生轴向运动。Please refer to FIG. 13 and FIG. 14 together, the inner wall of thehousing 410 is provided with a plurality ofgrooves 413 arranged in parallel, the fixingrod 610 is provided with astopper 613 , and theelastic piece 620 is located at the distal end of thestopper 613 and the shell Between the distal ends of thebody 410, thestopper 613 can be rotated relative to thehousing 410. When thestopper 613 is rotated to engage in thegroove 413, the position of thehousing 410 relative to the fixingrod 610 is fixed, that is, thehousing 410 cannot move axially relative to the fixedrod 610 . Specifically, thestopper 613 is a protruding block protruding from the surface of the fixingrod 610 , and the protruding block is matched with thegroove 413 . Referring to FIG. 13 , when the protrusion is in a horizontal state, that is, when the protrusion and thegroove 413 are at 90° in the depth direction, thehousing 410 can move axially relative to the fixingrod 610 . Referring to FIG. 14 , when the fixingrod 610 is rotated 90°, the protrusion is engaged with thegroove 413 , and no axial movement occurs between thehousing 410 and the fixingrod 610 .

在一实施例中，固定杆610的外表面设置有刻度(图未示)，用于显示出系绳12的张力值。In one embodiment, the outer surface of the fixingrod 610 is provided with a scale (not shown) for displaying the tension value of thetether 12 .

在使用时，将系绳12从心尖垫片13的中心孔13b穿出后，依次通过系绳通道601、壳体410，并通过系绳锁定件420穿出；将心尖垫片13固定在推送组件500上(具体过程可参照实施例一将心尖垫片固定至弹性管的过程)，并将心尖垫片13输送至贴近心尖的位置；拉动系绳12，以使系绳12向近端拉直，即系绳12无打折弯曲等情况，通过系绳锁定件420锁定系绳12的长度；将壳体410向近端移动，此时弹性件620被压缩，当壳体410移动至使系绳12达到合适的张力值，例如在超声检查下无瓣周漏的发生，将壳体410相对于固定杆610旋转90°至止挡件613卡合在凹槽413内，此时系绳12的力值显示在壳体410的远端端面指向在固定杆610外侧的数值。将系绳12固定在心尖垫片13上，并撤去测力装置40。当然，在一实施例中，当调节好系绳12的张力值后，也可以先撤去测力装置40，再将系绳12固定在心尖垫片13上。In use, after passing thetether 12 from thecentral hole 13b of theapex spacer 13, it passes through thetether channel 601, thehousing 410, and thetether locking piece 420 in sequence; fix theapex spacer 13 on the pusher (For the specific process, please refer to the process of fixing the apical spacer to the elastic tube in Embodiment 1), and deliver theapical spacer 13 to a position close to the apex of the heart; pull thetether 12 to pull thetether 12 toward the proximal end If thetether 12 is straight, that is, thetether 12 is not bent or bent, the length of thetether 12 is locked by thetether locking member 420; thehousing 410 is moved to the proximal end, and theelastic member 620 is compressed at this time. When therope 12 reaches a suitable tension value, for example, no paravalvular leakage occurs under the ultrasonic examination, thecasing 410 is rotated 90° relative to the fixingrod 610 until thestopper 613 is engaged in thegroove 413, and thetether 12 is at this time. The force value is displayed on the distal end face of thehousing 410 pointing to the outside of the fixingrod 610 . Thetether 12 is fastened to theapical spacer 13 and theforce measuring device 40 is removed. Of course, in an embodiment, after adjusting the tension value of thetether 12 , theforce measuring device 40 can also be removed first, and then thetether 12 can be fixed on theapex spacer 13 .

请参阅图15至图18，本申请第三实施例的测力装置70包括手柄组件700、推送组件800、系绳固定件900及测力装置1000，推送组件800位于手柄组件700的远端，系绳固定组件900及测力装置1000设置在手柄组件700的近端。15 to 18 , theforce measuring device 70 according to the third embodiment of the present application includes ahandle assembly 700 , apush assembly 800 , atether fixing member 900 and aforce measuring device 1000 , and thepush assembly 800 is located at the distal end of thehandle assembly 700 , Thetether securing assembly 900 and theforce measuring device 1000 are disposed at the proximal end of thehandle assembly 700 .

在一实施例中，手柄组件700包括壳体710及转动设置于壳体710上的旋钮720。具体的，壳体710上设置有收容槽711，旋钮720收容于收容槽711内，旋钮720能在收容槽711内转动。旋钮720的外侧设置有防滑纹路。In one embodiment, thehandle assembly 700 includes ahousing 710 and aknob 720 rotatably disposed on thehousing 710 . Specifically, thehousing 710 is provided with anaccommodating groove 711 , theknob 720 is accommodated in theaccommodating groove 711 , and theknob 720 can be rotated in theaccommodating groove 711 . The outer side of theknob 720 is provided with anti-skid lines.

推送组件800用于与心尖垫片13可释放地连接。推送组件800的具体结构可参照实施例一中的推送组件200，在此不再赘述。Thepusher assembly 800 is used for releasable connection with theapical spacer 13 . For the specific structure of thepush component 800, reference may be made to thepush component 200 in the first embodiment, which will not be repeated here.

系绳固定组件900用于将系绳12夹紧。请参阅图16至图18，系绳固定组件900包括固定座910、压块920及压杆930，固定座910设置于手柄组件700内，系绳12穿过所述固定座910，压块920与压杆930固定连接，压杆930与固定座910活动连接，压杆930带动压块920朝向固定座910移动以将穿过固定座910的系绳12夹紧。Tether securingassembly 900 is used to clamptether 12. 16 to 18 , thetether fixing assembly 900 includes a fixingseat 910 , apressing block 920 and apressing rod 930 , the fixingseat 910 is disposed in thehandle assembly 700 , thetether 12 passes through the fixingseat 910 , and thepressing block 920 It is fixedly connected with thepressing rod 930 , thepressing rod 930 is movably connected with the fixingseat 910 , and thepressing rod 930 drives thepressing block 920 to move toward the fixingseat 910 to clamp thetether 12 passing through the fixingseat 910 .

在一实施例中，固定座910上设置有供系绳12通过的通槽911，通槽911位于固定座910的中轴线上，通槽911的上部为方形，通槽911的底部为半圆弧形。压块920滑动设置于通槽911的侧壁，且与通槽911的侧壁接触，压块920的底部与通槽911的底部的形状匹配。当压块920在固定座910的通槽911中移动到底部时，两者完全吻合，通过这样的结构，可以将系绳12锁定在固定座910上。通槽911的底部为半圆弧形的设计，可以使得压块920在向下移动的过程中，系绳12最终推向通槽911的底部，减小系绳12与通槽911的底部的缝隙，避免系绳12在固定后被移动。In one embodiment, the fixingbase 910 is provided with a through slot 911 for thetether 12 to pass through. The through slot 911 is located on the central axis of the fixingbase 910 , the upper part of the through slot 911 is square, and the bottom of the through slot 911 is a semi-circular arc. shape. Thepressing block 920 is slidably disposed on the side wall of the through slot 911 and is in contact with the side wall of the through slot 911 , and the bottom of thepressing block 920 matches the shape of the bottom of the through slot 911 . When thepressing block 920 moves to the bottom in the through groove 911 of the fixingseat 910 , the two are completely matched, and thetether 12 can be locked on the fixingseat 910 through such a structure. The bottom of the through slot 911 is designed in a semi-circular arc shape, so that thetether 12 is finally pushed to the bottom of the through slot 911 during the downward movement of thepressing block 920 , reducing the gap between thetether 12 and the bottom of the through slot 911 , to prevent thetether 12 from being moved after being secured.

固定座910的顶部设置有螺纹孔，压杆930上设置有与螺纹孔匹配的螺纹结构，压杆930穿设于螺纹孔，并与固定座910的螺纹孔螺纹连接。压杆930的底部与压块920固定连接，当旋转压杆930，压块920会朝向或远离固定座910移动，从而将系绳12锁定或松开。The top of the fixingseat 910 is provided with a threaded hole, and thepressing rod 930 is provided with a threaded structure matching the threaded hole. The bottom of thepressing rod 930 is fixedly connected with thepressing block 920 . When thepressing rod 930 is rotated, thepressing block 920 will move toward or away from the fixingseat 910 , thereby locking or releasing thetether 12 .

在一实施例中，系绳固定组件900还包括设置于固定座910近端的延伸管940，延伸管940用于将系绳12引出到手柄组件100的外侧。延伸管940的一端与通槽911连通，另一端伸出手柄组件700外。在图示的实施例中，延伸管940为圆弧形的管。In one embodiment, thetether fixing assembly 900 further includes anextension tube 940 disposed at the proximal end of the fixingbase 910 , and theextension tube 940 is used to lead thetether 12 to the outside of thehandle assembly 100 . One end of theextension tube 940 communicates with the through groove 911 , and the other end extends out of thehandle assembly 700 . In the illustrated embodiment, theextension tube 940 is an arc-shaped tube.

测力组件1000包括螺旋轴1010及设置于螺旋轴1010近端的测力传感器1020。螺旋轴1010的远端与推送组件800连接，螺旋轴1010的近端滑动设置于手柄组件700，螺旋轴1010内设置有用于系绳12穿过的系绳通道1011。测力传感器1020设置于手柄组件700内，测力传感器1020与系绳固定组件900连接。手柄组件700能够相对于螺旋轴1010轴向移动以调节穿过螺旋轴1010的系绳通道1011的系绳12的张力，测力传感器1020用于测定系绳的张力。Theforce measuring assembly 1000 includes ascrew shaft 1010 and aload cell 1020 disposed at the proximal end of thescrew shaft 1010 . The distal end of thehelical shaft 1010 is connected to thepush assembly 800 , the proximal end of thehelical shaft 1010 is slidably disposed on thehandle assembly 700 , and atether channel 1011 for thetether 12 to pass through is provided in thehelical shaft 1010 . Theload cell 1020 is disposed in thehandle assembly 700 , and theload cell 1020 is connected to thetether fixing assembly 900 . Thehandle assembly 700 is axially movable relative to thescrew shaft 1010 to adjust the tension of thetether 12 passing through thetether channel 1011 of thescrew shaft 1010, and theload cell 1020 is used to measure the tension of the tether.

在一实施例中，螺旋轴1010滑动设置于壳体710内。具体的，壳体710内设置有滑槽712，螺旋轴1010的近端设置有凸起1012，凸起1012滑动设置于滑槽712内。在图示的实施例中，壳体710内设置有两条平行的滑槽712，螺旋轴1010的近端设置有两个凸起1012，两个凸起1012分别在两个平行的滑槽712中轴向滑动。滑槽712的长度可以为10cm，凸起1012可以在滑槽712内滑动的距离为0-10cm。In one embodiment, thescrew shaft 1010 is slidably disposed in thehousing 710 . Specifically, thehousing 710 is provided with achute 712 , the proximal end of thescrew shaft 1010 is provided with aprotrusion 1012 , and theprotrusion 1012 is slidably disposed in thechute 712 . In the illustrated embodiment, two parallel slidinggrooves 712 are provided in thehousing 710 , twoprotrusions 1012 are provided at the proximal end of thescrew shaft 1010 , and the twoprotrusions 1012 are respectively in the two parallel slidinggrooves 712 The central axis slides. The length of thechute 712 can be 10 cm, and the distance that theprotrusion 1012 can slide in thechute 712 is 0-10 cm.

在一实施例中，螺旋轴1010位于手柄组件700的中轴线上。螺旋轴1010的远端与推送组件800固定连接。具体的，螺旋轴1010与推送组件800通过锚定连接。螺旋轴1010具有中空的腔体，该腔体为用于系绳12穿过的系绳通道1011。螺旋轴1010的外侧具有外螺纹1014，旋钮720的内侧具有相匹配的内螺纹(图未示)，螺旋轴1010与旋钮720通过外螺纹1014与内螺纹连接。当转动旋钮720时，螺旋轴1010可以轴向移动。In one embodiment, thescrew shaft 1010 is located on the central axis of thehandle assembly 700 . The distal end of thescrew shaft 1010 is fixedly connected with thepush assembly 800 . Specifically, thescrew shaft 1010 and thepush assembly 800 are connected by anchoring. Thehelical shaft 1010 has a hollow cavity, which is atether channel 1011 for thetether 12 to pass through. The outer side of thescrew shaft 1010 has anexternal thread 1014 , the inner side of theknob 720 has a matching internal thread (not shown), and thescrew shaft 1010 and theknob 720 are connected with the internal thread through theexternal thread 1014 . When theknob 720 is turned, thescrew shaft 1010 can move axially.

测力传感器1020固定设置于壳体710内。测力传感器1020与系绳固定组件900固定连接。在一实施例中，测力传感器1020与固定座910固定连接。测力传感器1020上还连接有连接线1021，连接线1021远离测力传感器1020的一端伸出壳体710，连接线1021用于连接外部显示器。测力传感器70的结构可以参照现有技术，在此不再赘述。Theload cell 1020 is fixedly arranged in thecasing 710 . Theload cell 1020 is fixedly connected to thetether securing assembly 900 . In one embodiment, theload cell 1020 is fixedly connected with the fixingbase 910 . Theload cell 1020 is also connected with a connectingwire 1021 , one end of the connectingwire 1021 away from theload cell 1020 extends out of thehousing 710 , and the connectingwire 1021 is used for connecting to an external display. The structure of theload cell 70 can be referred to in the prior art, which is not repeated here.

在使用时，将系绳12从心尖垫片13的中心孔13b穿出后，依次通过系绳通道1011、壳体710，并通过系绳固定组件900穿出；将心尖垫片13固定在推送组件800上(具体过程可参照实施例一将心尖垫片固定至弹性管的过程)，并将心尖垫片13输送至贴近心尖的位置；拉动系绳12，以使系绳12向近端拉直，即系绳12无打折弯曲等情况，通过系绳固定组件900锁定系绳12的长度；转动旋钮720使壳体710相对于螺旋轴1010移动，系绳12的张力值被调节，系绳12的力值可以被测力传感器测出；当壳体710移动至使使系绳12达到合适的张力值，例如在超声检查下无瓣周漏的发生，将系绳12固定在心尖垫片13上，并撤去测力装置70。当然，在一实施例中，当调节好系绳12的张力值后，也可以先撤去测力装置70，再将系绳12固定在心尖垫片13上。In use, after passing thetether 12 from thecentral hole 13b of theapex spacer 13, it passes through thetether channel 1011, thehousing 710 in turn, and passes through thetether fixing assembly 900; theapex spacer 13 is fixed in the pusher (For the specific process, please refer to the process of fixing the apical spacer to the elastic tube in Embodiment 1), and deliver theapical spacer 13 to the position close to the apex of the heart; pull thetether 12 to pull thetether 12 toward the proximal end Straight, that is, thetether 12 is not bent or bent, the length of thetether 12 is locked by thetether fixing assembly 900; theknob 720 is rotated to move thehousing 710 relative to thescrew shaft 1010, the tension value of thetether 12 is adjusted, and thetether 12 is adjusted. The force value of 12 can be measured by the force transducer; when thehousing 710 is moved to bring thetether 12 to a suitable tension value, such as no paravalvular leakage under ultrasound examination, thetether 12 is fixed to theapical spacer 13, and remove theforce measuring device 70. Of course, in one embodiment, after adjusting the tension value of thetether 12 , theforce measuring device 70 can also be removed first, and then thetether 12 can be fixed on theapex spacer 13 .

以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.

以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those skilled in the art, without departing from the concept of the present invention, several modifications and improvements can be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims (10)

Translated fromChinese

1.一种推送组件，所述推送组件用于与心尖垫片可释放地连接，所述心尖垫片用于将植入到心脏内的心脏瓣膜的系绳固定在心脏外，其特征在于，包括：1. A push assembly for releasably connecting with an apical spacer for securing a tether of a heart valve implanted in the heart outside the heart, characterized in that, include:推送外壳；push the shell;接合件，所述接合件设置于所述推送外壳上，且远端伸出所述推送外壳，所述接合件用于与所述心尖垫片连接，所述心尖垫片设置有用于与所述接合件连接的固定孔，所述接合件的远端插设于所述固定孔，当所述心尖垫片装载至所述接合件后，所述接合件的远端的尺寸大于所述固定孔，当所述接合件释放所述心尖垫片时，所述接合件的远端的尺寸减小至从所述固定孔中脱离。an engaging piece, the engaging piece is arranged on the pushing shell, and the distal end extends out of the pushing shell, the engaging piece is used for connecting with the apex spacer, and the apex spacer is provided with a fixing hole to which the engaging piece is connected, the distal end of the engaging piece is inserted into the fixing hole, and after the cardiac apex spacer is loaded into the engaging piece, the size of the distal end of the engaging piece is larger than that of the fixing hole , when the engagement member releases the apical spacer, the distal end of the engagement member is reduced in size to disengage from the securing hole.2.根据权利要求1所述的推送组件，其特征在于，所述接合件包括：2. The push assembly of claim 1, wherein the engaging member comprises:弹性管，所述弹性管固定设置于所述推送外壳，所述弹性管的远端伸出所述推送外壳，且所述弹性管的延伸方向与所述推送外壳的中心轴平行，所述弹性管的远端用于与所述心尖垫片连接；an elastic tube, the elastic tube is fixedly arranged on the push housing, the distal end of the elastic tube extends out of the push housing, and the extension direction of the elastic tube is parallel to the central axis of the push housing, the elastic tube extends the distal end of the tube is used to connect with the apical spacer;填充芯，所述填充芯可滑动设置于所述弹性管内，当所述填充芯滑动至与所述弹性管的远端齐平时，所述弹性管的远端的尺寸大于所述固定孔，当所述填充芯向近端回撤时，所述弹性管的远端的尺寸减小至从所述固定孔中脱离。A filling core, the filling core can be slidably arranged in the elastic tube, when the filling core slides to be flush with the distal end of the elastic tube, the size of the distal end of the elastic tube is larger than the fixing hole, when As the core is retracted proximally, the distal end of the elastic tube is reduced in size to disengage from the fixation hole.3.根据权利要求2所述的推送组件，其特征在于，所述弹性管的远端周壁上设置有多个缺口。3 . The push assembly according to claim 2 , wherein a plurality of notches are provided on the peripheral wall of the distal end of the elastic tube. 4 .4.根据权利要求2所述的推送组件，其特征在于，所述接合件还包括：4. The push assembly according to claim 2, wherein the joint further comprises:推送块，所述推送块滑动设置于所述推送外壳，所述填充芯固定设置于所述推送块，且所述填充芯的远端伸出所述推送块。A push block, the push block is slidably arranged on the push shell, the filling core is fixedly arranged on the push block, and the distal end of the filling core extends out of the push block.5.根据权利要求4所述的推送组件，其特征在于，所述推送外壳内设置有弹簧，所述推送块与所述弹簧连接。5 . The push assembly according to claim 4 , wherein a spring is provided in the push housing, and the push block is connected with the spring. 6 .6.根据权利要求5所述的推送组件，其特征在于，所述推送块的远端与所述弹簧的近端抵接。6. The push assembly of claim 5, wherein the distal end of the push block abuts against the proximal end of the spring.7.根据权利要求4所述的推送组件，其特征在于，所述推送外壳的侧壁设置有滑轨，所述推送块滑动设置于所述滑轨内。7 . The push assembly according to claim 4 , wherein a side wall of the push housing is provided with a slide rail, and the push block is slidably arranged in the slide rail. 8 .8.根据权利要求2所述的推送组件，其特征在于，所述弹性管及所述填充芯的数量均为2个。8 . The push assembly according to claim 2 , wherein the number of the elastic tubes and the filling cores are both two. 9 .9.根据权利要求2所述的推送组件，其特征在于，所述固定孔为盲孔。9 . The push assembly according to claim 2 , wherein the fixing hole is a blind hole. 10 .10.一种测力装置，其特征在于，包括权利要求1～9中任一所述的推送组件。10 . A force measuring device, characterized in that it comprises the push assembly according to any one of claims 1 to 9 . 11 .

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