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CN105852916B - 一种经心尖植入的二尖瓣柔性闭合板阻塞体及植入方法 - Google Patents

一种经心尖植入的二尖瓣柔性闭合板阻塞体及植入方法 Download PDF

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CN105852916B
CN105852916B CN201610229742.0A CN201610229742A CN105852916B CN 105852916 B CN105852916 B CN 105852916B CN 201610229742 A CN201610229742 A CN 201610229742A CN 105852916 B CN105852916 B CN 105852916B
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closure plate
heart
apex
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bicuspid valve
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CN105852916A (zh
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贺照明
荆腾
张凯亮
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Shanghai Medical Instrument Co., Ltd.
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Priority to PCT/CN2016/108785 priority patent/WO2017177701A1/zh
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    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2/2487—Devices within the heart chamber, e.g. splints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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Abstract

本发明公开一种人体心脏修复技术领域中经心尖植入的二尖瓣柔性闭合板阻塞体及植入方法，将柔性闭合板通过人体左侧胸部小切口植入，经心尖进入左心室，放置并固定到二尖瓣前后瓣叶闭合处的反流孔位置，当心脏舒张时，二尖瓣打开，血液通过前、后瓣叶和闭合板之间的两条通道从左心房流入左心室；当心脏收缩时，前、后瓣叶关闭，瓣叶边缘挤压闭合板，使其轻微变形，瓣叶边缘和轻微变形的闭合板紧密结合在一起，阻塞了二尖瓣的反流通道，有效地防止了二尖瓣的反流；柔性闭合板阻塞体的结构简单，可靠性强，其植入方法对人体的创伤小，残余反流发生率很低，能够进行功能性二尖瓣关闭不全等疾病的治疗，修复功能型二尖瓣反流成功率达90%以上。

Description

一种经心尖植入的二尖瓣柔性闭合板阻塞体及植入方法
技术领域
本发明涉及人体心脏修复技术和医疗器械领域，尤其是一种能修复心脏二尖瓣反流的器械。
背景技术
人体心脏和瓣膜如图1所示，左心室3位于心尖4左上方，二尖瓣2位于左心房1和左心室3之间，二尖瓣2控制血液从左心房1单向流入左心室3。功能失调的二尖瓣2会导致二尖瓣2的两瓣叶关闭不全，使血液在心脏收缩期从左心室3反流回左心房1。二尖瓣反流将引起肺充血和左心室3肥大，最终导致病人的心衰和死亡。
二尖瓣2的结构如图2所示，二尖瓣2是一个复杂的承受血压的单向阀结构，由二尖瓣环2.1、前瓣叶2.2、后瓣叶2.3、腱索2.4、乳头肌2.5和左心室壁上的心肌组成。乳头肌2.5附着于左心室壁上，前瓣叶2.2、后瓣叶2.3附着在二尖瓣环2.1上。二尖瓣环2.1是一个连接前瓣叶2.2、后瓣叶2.3和左心室壁的内部组织结构。根据二尖瓣环2.1的组织结构，它被分成前内侧段的纤维层和后外侧段的肌肉层。腱索2.4起始于乳头肌2.5，附着于瓣叶上，能够防止心脏收缩时前瓣叶2.2、后瓣叶2.3塌陷进入左心房1。
功能正常的二尖瓣闭合时的状态如图3、图4所示，二尖瓣关闭后前瓣叶2.2、后瓣叶2.3之间没有间隙，前后瓣叶结合处5之间完全闭合，不会产生反流现象。当二尖瓣2闭合时的状态如图5、图6所示时，二尖瓣2的前后瓣叶结合处5之间有间隙出现，前后瓣叶结合处5间的间隙使血液在心脏收缩时从左心室3回流到左心房1（如图5中的箭头所示的反流方向），这种回流称为二尖瓣反流，二尖瓣反流会降低心脏效率并导致心衰。
目前，对于二尖瓣反流的治疗方法，主要有瓣环整形术、机械二尖瓣或生物二尖瓣的移植等等，这些大多需要开胸、开心，对人体创伤大，可靠性不高，导致治疗后5年内50%的二尖瓣反流重新复发。现有的比较先进的微创治疗方法是通过二尖瓣钳夹，将前后瓣叶边缘的中点夹在一起，形成两个独立的血流通道，减少血液的反流，但是这种方法有残余反流发生。
发明内容
本发明的目的是解决现有二尖瓣反流治疗方法存在的问题，提供一种修复二尖瓣反流的经心尖植入的二尖瓣柔性闭合板阻塞体，阻塞二尖瓣的反流通道，有效防止二尖瓣的反流；本发明同时还提供该二尖瓣柔性闭合板阻塞体的植入方法，经微创手术植入到二尖瓣前后瓣叶闭合处的反流孔位置，不需要开胸、开心，对人体创伤小，无残余反流发生，可靠性高。
为了达到以上目的，本发明一种经心尖植入的二尖瓣柔性闭合板阻塞体采用的技术方案是：所述二尖瓣柔性闭合板阻塞体包括柔性闭合板、导引线、导向环和固定塞，所述固定塞固定植入在心脏的心尖处，所述柔性闭合板位于心脏的前后瓣叶结合处，在前后瓣叶结合处的左、右侧的二尖瓣环中各固定植入有一个钩卡，左、右两根导引线分别穿过同侧的钩卡且固定连接柔性闭合板的同侧上部，柔性闭合板的左下部和右下部各固定连接一个导向环，左、右两根导引线分别穿过同侧的导向环并固定连接所述固定塞。
进一步地，所述柔性闭合板的纵截面为倒等腰梯形结构，柔性闭合板能够沿上底边或下底边卷曲成细长的圆柱体。
进一步地，柔性闭合板下底边的边缘内沿下底边的长度方向嵌入有一条支撑杆，柔性闭合板的下底边固定连接牵引线一端，牵引线另一端固定连接固定塞。
更进一步地，所述牵引线有多根，多根牵引线一端沿柔性闭合板下底边的长度方向均匀连接柔性闭合板，多根牵引线的另一端均固定连接于固定塞。
所述经心尖植入的二尖瓣柔性闭合板阻塞体的植入方法采用的技术方案是：在胸部左侧心尖位置做一个小切口直通心尖，在心尖位置做一个荷包手术，将心尖套管从荷包中插入左心室，收紧荷包固定心尖套管，还包含以下步骤：
A、将导引线穿在钩卡上，钩卡放置在钩卡植入导管中，钩卡植入导管经心尖套管进入左心室到达前后瓣叶结合处，通过推杆将钩卡从钩卡植入导管中推出，使钩卡插入在二尖瓣环中；先后两次分别将两个钩卡分别植入在前后瓣叶结合处的左、右侧的二尖瓣环中；在两个钩卡植入后退出钩卡植入导管，穿过钩卡的两根导引线的两端都通过心尖导管引到体外；
B、在体外先将柔性闭合板和导向环组成一个整件，将体外的两根导引线一端各自分别和柔性闭合板同侧上部固定连接、另一端各自分别穿过同侧的导向环；再将柔性闭合板卷曲成圆柱体，将圆柱体的整件放入闭合板植入导管中，闭合板植入导管经心尖套管进入到左心室内部，推出柔性闭合板使其展开，穿过导向环的导引线经闭合板植入导管引向体外，最后拉紧导引线使柔性闭合板的左上部和右上部分别位于同侧的钩卡位置；
C、退出闭合板植入导管，取出心尖套管，用固定塞锁紧导引线。
进一步地，步骤B中，在体外将柔性闭合板下底边固定连接牵引线一端，同时将支撑杆固定嵌入在柔性闭合板的下底边缘内，柔性闭合板连同导向环、支撑杆和牵引线一端一起放入闭合板植入导管中。
本发明采用上述技术方案后具有的优点是：本发明所述二尖瓣柔性闭合板阻塞体中的柔性闭合板由延展性极好的柔性材料制成，通过人体左侧胸部小切口植入，经心尖进入左心室，放置并固定到二尖瓣前后瓣叶闭合处的反流孔位置，当心脏舒张时，二尖瓣打开，血液通过前、后瓣叶和闭合板之间的两条通道从左心房流入左心室；当心脏收缩时，前、后瓣叶关闭，瓣叶边缘挤压闭合板，使其轻微变形，瓣叶边缘和轻微变形的闭合板紧密结合在一起，阻塞了二尖瓣的反流通道，有效地防止了二尖瓣的反流。柔性闭合板阻塞体的结构简单，可靠性强，其植入方法对人体的创伤小，残余反流发生率很低，能够进行功能性二尖瓣关闭不全等疾病的治疗，修复功能型二尖瓣反流成功率达90%以上。
附图说明
下面结合附图以及具体实施方式对本发明作进一步的说明，但本发明的保护范围并不限于此。
图1为心脏的结构和二尖瓣位置图；
图2为图1中二尖瓣的组织结构放大图；
图3为图2中二尖瓣关闭时的右侧视图；
图4为图2中二尖瓣关闭时的心房局部放大图；
图5为图2中心脏收缩二尖瓣关闭不全时二尖瓣反流的右侧视图；
图6为图2中心脏收缩二尖瓣关闭不全时的二尖瓣反流的心房局部放大图；
图7为本发明所述一种经心尖植入的二尖瓣柔性闭合板阻塞体植入后的示意图；
图8为图7中钩卡结构放大图；
图9为图8中的钩卡放置在钩卡植入导管中的示意图；
图10为本发明一种经心尖植入的二尖瓣柔性闭合板阻塞体的植入状态示意图。
图中：1-左心房，2-二尖瓣，2.1-二尖瓣环，2.2-前瓣叶，2.3-后瓣叶，2.4-腱索，2.5-乳头肌，3-左心室，4-心尖，5-前后瓣叶结合处，6-钩卡，6.1-倒钩，6.2-连接环，7-柔性闭合板，8-导引线，9-钩卡植入导管，10-牵引线，11-闭合板植入导管，12-固定塞，13-导向环，14-支撑杆。
具体实施方式
参见图7，本发明一种经心尖植入的二尖瓣柔性闭合板阻塞体的结构包括钩卡6、柔性闭合板7、导引线8、牵引线10、导向环13、支撑杆14和固定塞12。固定塞12植入在心尖4处。有2个钩卡6，分别植入在前后瓣叶结合处5的二尖瓣环2.1上的左侧和右侧位置。柔性闭合板7选用延展性极好的柔性材料制成，纵截面的形状为倒立的等腰梯形结构，前后厚度为5-6mm，等腰梯形的上底边长的长度大于下底边长，柔性闭合板7能够沿自身的相互平行的上底边或下底边紧密卷曲成细长的圆柱体。柔性闭合板7植入后放置在心脏的二尖瓣的前后瓣叶之间，在前瓣叶2.2和后瓣叶2.3游离边缘的前后瓣叶结合处5，柔性闭合板7用于阻塞两瓣叶关闭不全形成的反流通道。柔性闭合板7的左下部和右下部各固定连接一个导向环13。有左、右两根导引线8，左、右两根导引线8分别穿过同侧的钩卡6，导引线8固定连接柔性闭合板7的同侧上部，即柔性闭合板7的左上部经第一根导引线8固定连接左侧的钩卡6，柔性闭合板7的右上部经第二根导引线8固定连接右侧的钩卡6。左、右两根导引线8同时穿过同侧的导向环13后向下延伸到心尖4或者乳头肌2.5处的固定塞12处，即第一根导引线8穿过左侧的导向环13后向下延伸固定连接于固定塞12，第二根导引线8穿过右侧的导向环13后向下延伸固定连接于固定塞12。导向环13用于限定导引线8的走向。
柔性闭合板7的下底边固定连接牵引线10一端，牵引线10另一端固定连接固定塞12。本发明中的牵引线10有多根，多根牵引线10一端沿柔性闭合板7下底边的长度方向均匀连接柔性闭合板7，多根牵引线10的另一端均固定连接于固定塞12，通过牵引线10固定柔性闭合板7的位置。这样，使柔性闭合板7经钩卡6、牵引线10和固定塞12放置在最佳位置。
在柔性闭合板7下底边的边缘内、沿下底边的长度方向嵌入一条支撑杆14，使支撑杆14与柔性闭合板7的下底边保持平行。支撑杆14用于支撑柔性闭合板7，防止牵引线10牵拉柔性闭合板7时柔性闭合板7发生弯曲变形。
钩卡6由镍钛记忆合金材料制成，导引线8和牵引线10均为ePTFE（膨体聚四氟乙烯）材料制成，支撑杆14为刚性材料制成，柔性闭合板7选用延展性极好的血液相容性的柔性材料制成，固定塞12为血液相容性材料制成，固定塞12能够锁定导引线8和牵引线10并固定在心尖4或乳头肌2.5位置。血液相容性的材料为聚氨酯或心包膜材料，柔性闭合板7可选用聚氨酯制作。
参见图8，钩卡6由倒钩6.1和连接环6.2两部分组成，一端是两个倒钩6.1，另一端是一个连接环6.2，钩卡6植入时以倒钩6.1部分固定卡在瓣环2.1上，导引线8穿在连接环6.2上并固定连接柔性闭合板7，通过导引线8使柔性闭合板7与钩卡6固定。
参见图9，钩卡6植入心脏前，要先将钩卡6置入钩卡植入导管9中，钩卡植入导管9的内径与钩卡6的连接环6.2的外径相适应。钩卡6置入时，将倒钩6.1部分略作弯曲变形后置入钩卡植入导管9的前端。
参见图1-10，将所述二尖瓣柔性闭合板阻塞体植入心脏内的方法是：
步骤1：首先，在胸部左侧心尖位置做一个小的切口，直通心尖4，并在心尖4位置做一个荷包手术，将心尖套管从荷包中插入左心室3，收紧荷包，固定心尖套管。心尖套管通过止血钳夹住，防止心脏血液从植入位置流出；然后将两根导引线8各穿在钩卡6的连接环6.2上，先后两次分别将连接环6.2上穿有导引线8的两个钩卡6分别植入在前后瓣叶结合处5的左、右侧的二尖瓣环2.1中。其具体方法为：先将第一根导引线8穿在第一个钩卡6的连接环6.2上，再将该第一个钩卡6放置在钩卡植入导管9中，松开心尖套管的止血钳，将钩卡植入导管9由左侧胸部小切口经心尖套管进入左心室3，到达二尖瓣的前瓣叶2.2和后瓣叶2.3间隙两端的二尖瓣环2.1位置，通过推杆将该第一个钩卡6从钩卡植入导管9的前端推出，倒钩6.1被推出展开后通过其弹性使倒钩6.1插入在二尖瓣环2.1的左端位置中。再退出钩卡植入导管9，心尖套管通过止血钳夹住。用同样的方法，将第二根导引线8穿在第二个钩卡6的连接环6.2上，再将该第二个钩卡6放置在钩卡植入导管9中，松开心尖套管的止血钳，将钩卡植入导管9经心尖套管进入左心室3，将第二个钩卡6的倒钩6.1插入在二尖瓣环2.1的右端位置中。这样，两个钩卡6植入后，退出钩卡植入导管9。此时，穿过钩卡6的每根导引线8的两端都通过心尖导管引到体外，用止血钳夹紧心尖导管，防止心脏出血。
步骤2：在体外，将柔性闭合板7的左下部固定一个左侧导向环13、右下部固定连接一个右侧导向环13。或者在制造柔性闭合板7时，就将导向环13与柔性闭合板7一起做成一个整件。引到体外的两根导引线8体外端的一端各自分别和柔性闭合板7同侧上部固定连接、另一端各自分别穿过同侧的导向环13。 即：将第一根导引线8一端和柔性闭合板7的左上部固定连接，第一根导引线8另一端穿过固定在柔性闭合板7上的左侧的导向环13，第二根导引线8一端和柔性闭合板7的右上部固定连接，第二根导引线8另一端穿过固定在柔性闭合板7上的右侧的导向环13。
将柔性闭合板7的下底边固定连接牵引线10一端，同时将支撑杆14固定嵌入在柔性闭合板7的下底边缘内。或者在制造柔性闭合板7时，就将导向环13、支撑杆14、牵引线10一端与柔性闭合板7一起做成一个整件。
将柔性闭合板7沿自身的相互平行的上底边或下底边紧密卷曲成细长的圆柱体，柔性闭合板7连同导向环13、支撑杆14以及牵引线10一端均一起放入闭合板植入导管11中，松开心尖套管的止血钳，将闭合板植入导管11由胸部左侧的小切口植入，经心尖套管进入到左心室3内部。此时，穿过导向环13的导引线8从心尖4经闭合板植入导管11引向体外，牵引线10的另一端也经闭合板植入导管11伸出在体外。
步骤3：将柔性闭合板7从闭合板植入导管11中推出，在左心室3内部展开，调节两根穿过导向环13的导引线8的体外端，拉紧导引线8，使柔性闭合板7的左上部和右上部分别位于同侧的钩卡6位置，将柔性闭合板7在前后瓣叶结合处5固定好。调节牵引线10，使柔性闭合板7下底边通过牵引线10另一端拉紧。
步骤4：退出闭合板植入导管11，钳紧心尖套管，松开荷包，将心尖套管取出，再收紧荷包，防止心脏出血。将导引线8和牵引线10的体外端穿过固定塞12，将固定塞12推向心尖4位置，松开荷包，将固定塞12放置到心尖4后，收紧荷包固定。调整牵引线10和导引线8的拉力达到最佳后，通过固定塞12锁紧牵引线10和导引线8，将固定塞12外面多余的牵引线10和导引线8剪除。固定塞12一端细小，伸入心尖4，另一端部面积较大，贴近心尖4表面，固定塞12中间有孔，牵引线10从孔中引出，用固定塞12锁紧固定，这样可以将牵引线10的受力均匀分布在心尖4表面。
步骤5：将胸部左侧小切口缝合，二尖瓣柔性闭合板阻塞体的植入过程结束。
当心脏舒张时，二尖瓣2打开，血液通过前瓣叶2.2、后瓣叶2.3和柔性闭合板7之间的两条通道从左心房1流入左心室3；当心脏收缩时，前瓣叶2.2和后瓣叶2.3关闭，瓣叶边缘挤压柔性闭合板7，使柔性闭合板7轻微变形，瓣叶边缘和轻微变形的柔性闭合板7紧密结合在一起，阻塞了二尖瓣2的反流通道，有效地防止了二尖瓣2的反流。

Claims (7)

1.一种经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：包括柔性闭合板(7)、导引线(8)、导向环(13)和固定塞(12)，所述固定塞(12)固定植入在心脏的心尖(4)处，所述柔性闭合板(7)位于心脏的前后瓣叶结合处，在前后瓣叶结合处的左、右侧的二尖瓣环(2.1)中各固定植入有一个钩卡(6)，左、右两根导引线(8)分别穿过同侧的钩卡(6)且固定连接柔性闭合板(7)的同侧上部，柔性闭合板(7)的左下部和右下部各固定连接一个导向环(13)，左、右两根导引线(8)分别穿过同侧的导向环(13)并固定连接所述固定塞(12)。
2.根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：柔性闭合板(7)下底边的边缘内沿下底边的长度方向嵌入有一条支撑杆(14)，柔性闭合板(7)的下底边固定连接牵引线(10)一端，牵引线(10)另一端固定连接固定塞(12)。
3.根据权利要求2所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：所述牵引线(10)有多根，多根牵引线(10)一端沿柔性闭合板(7)下底边的长度方向均匀连接柔性闭合板(7)，多根牵引线(10)的另一端均固定连接于固定塞(12)。
4.根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：所述柔性闭合板(7)的纵截面为倒等腰梯形结构，柔性闭合板(7)能够沿上底边或下底边卷曲成细长的圆柱体。
5.根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：钩卡(6)由镍钛记忆合金材料制成，固定塞(12)由血液相容性材料制成，柔性闭合板(7)由血液相容性的柔性材料制成，导引线(8)由膨体聚四氟乙烯材料制成。
6.根据权利要求2所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：牵引线(10)由膨体聚四氟乙烯材料制成，支撑杆(14)由刚性材料制成。
7.根据权利要求1所述经心尖植入的二尖瓣柔性闭合板阻塞体，其特征是：钩卡(6)由倒钩(6.1)和连接环(6.2)两部分组成，导引线穿在连接环(6.2)上。
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