CN106073945B - 一种用于治疗三尖瓣反流的异位植入瓣膜支架系统 - Google Patents
一种用于治疗三尖瓣反流的异位植入瓣膜支架系统 Download PDFInfo
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Abstract
本发明公开了一种用于治疗三尖瓣反流的异位植入瓣膜支架系统，包括支架、人工瓣膜和覆膜，所述支架为圆柱形管状，且具有网格结构，所述人工瓣膜被垂直于支架轴向地缝制在所述支架的内部，所述覆膜覆盖所述支架的至少一部分外周表面。该系统是一种经股静脉途径植入的瓣膜系统，系统植入到上腔静脉和/或下腔静脉中后，可防止从三尖瓣反流至心房血流进一步倒流回腔静脉内，从而达到治疗三尖瓣反流的目的，且该支架系统具有操作简单，制作工艺简单、成熟，安全性高的优点。
Description
技术领域
本发明涉及一种治疗三尖瓣反流的瓣膜支架系统，尤其涉及一种经皮异位植入的用于治疗三尖瓣反流的瓣膜支架系统。
背景技术
三尖瓣反流(TR)是常见的心脏疾病。严重的TR可以导致心排量的下降以及体循环淤血，是很多心脏疾病预后不良的信号，与患者预后密切相关。外科手术是目前TR最主要的治疗手段，但具有创伤大、并发症多、死亡率高等缺陷。因此，基于目前外科手术的局限性，寻找一种创伤小、操作简便、并发症少TR治疗方法十分必要。
随着生物医用材料的进步和医学影像学的发展，近10年来，经导管瓣膜置换和修复治疗取得突破性进展，成为介入心脏病学的热点。相对其他三个心脏瓣膜，三尖瓣疾病的经导管治疗发展相对滞后，绝大多数处于动物实验阶段。虽然有动物实验成功地完成了经导管原位三尖瓣置入治疗TR，但该方法带瓣膜支架脱落风险较高而未能应用于临床。
发明内容
有鉴于现有技术的上述缺陷，本发明所要解决的技术问题是如何实现使用经导管方法，植入瓣膜系统，治疗三尖瓣反流。
为实现上述目的，本发明提供了一种经股静脉途径植入的瓣膜系统，系统植入到上腔静脉和/或下腔静脉中后，可防止从三尖瓣反流至心房血流进一步倒流回腔静脉内，从而达到治疗三尖瓣反流的目的。
所述用于治疗三尖瓣反流的异位植入瓣膜支架系统包括支架、人工瓣膜和覆膜，所述支架为圆柱形管状，且具有网格结构，所述人工瓣膜被垂直于支架轴向地缝制在所述支架的内部，所述覆膜覆盖所述支架的至少一部分外周表面，用于防止瓣周漏的发生。
所述支架可由金属材料制成，也可由其它具有高支撑强度的材料制成，优选为由具有强回复力的弹性合金材料制成。
优选地，所述支架为圆柱形管状。
优选地，所述支架的网格结构由合金材料编织而成，且网孔粗大(孔眼的最大径向长度在4mm以上)，可以避免支架对腔静脉分支的堵塞；网孔的形状优选为菱形，有利于瓣膜的压缩。
所述支架的内径参考上下腔静脉内径的大小，优选为20-40mm，为了满足不同患者的不同需求，本发明的支架内径可设计多种尺寸供选择，如以3mm的内径增幅制造不同的支架型号。
优选地，所述支架的长度为40-60mm。
进一步，所述人工瓣膜含有3个瓣叶，被设置于距所述支架近心端1/2-1/4高度处，优选为1/3高度处。所述瓣叶的瓣叶间连接部分固定在支架网格上，其它边缘部分不缝合，可呈角度的开合，形成三个半月窦状并且其边缘能完全闭合在一起。
优选地，所述人工瓣膜由猪或牛心包制成,也可以为生物组织材料、高分子材料或组织工程瓣膜。
进一步，所述覆膜覆盖所述支架从近心端至距近心端1/2-1/4高度处的外周表面；优选为1/3高度处。所述覆膜可以完全覆盖这一近心段的外周表面，也可以部分覆盖这一段支架的的外周表面。该覆膜起到防止瓣周漏的作用。
优选地，所述覆膜由高分子材料制成，如聚乙烯等。
进一步，该瓣膜支架系统可在径向扩张的第一形态和径向收缩的第二形态之间变换；其中，所述第一形态为所述瓣膜支架系统被植入人体上腔静脉或下腔静脉后的工作形态，所述第二形态为所述瓣膜支架系统被经导管输送时的输送形态。
在本发明的一种优选实施例中，该瓣膜支架系统的所述支架由自膨胀材料制成，在体外可以压缩成条状的第二形态，但在体内释放后可以自动恢复到第一形态。
在本发明的另一种优选实施例中，该支架系统也采用球囊扩张原理释放，该系统在体外压缩成条状的第二形态，负载在球囊外面，到达体内后扩张球囊释放该系统，使得其恢复到第一形态。
本发明所述的瓣膜支架系统包括置于上腔静脉中的上腔瓣膜支架系统以及置于下腔静脉中的下腔静脉支架系统，通常情况下为一对用于上腔静脉和下腔静脉的瓣膜支架系统一起使用，但在某些情况下也可以单独使用。
进一步，本发明所使用的一对上下腔静脉的瓣膜支架系统可通过连接部件一体化连接。
本发明是根据心脏解剖特征(如图1所示)和病理生理而发明的：三尖瓣反流时，心脏收缩期的血液会反流到右心房继而涌回腔静脉，导致体循环血液瘀滞及心排量下降；而在腔静脉置入带瓣膜支架后，血液只反流到右心房，由于右心房体积有限，右心房压力会迅速上升，阻止血液进一步反流从而减少反流量，同时血液不返回腔静脉，体循环淤血会减少。虽然该方法存在着右心前负荷增加的缺陷，但右心前负荷增加可使得右心代偿性肥厚并通过Staring机制增加收缩力而增加心排量。在完美的“原位经导管三尖瓣置换”研发存在很大困难情况下，该方法对于右心肌功能未完全衰竭的TR者可能为一种有效治疗手段。
本发明提供的瓣膜支架系统及其植入方法有相对既往的“原位三尖瓣置换”有一些明显的优势，具有以下有益技术效果：
①操作简单：本发明的体内植入过程与现有的瓣膜支架植入过程类似，对定位要求低，只需把带瓣膜支架放置在腔静脉即可，故手术操作相对简单。
②制作工艺简单、成熟：本发明的基本材料和制作方法与现在常用的瓣膜支架系统相近，故制备相对简单、成熟。
③安全性高：由于腔静脉在心脏外围，上下腔静脉附近没有重要的解剖结构，带瓣膜支架压迫、影响心脏组织结构的风险性较低；而瓣膜支架粗大的网孔可以防止侧枝血管被堵塞，故安全性很高；由于腔静脉较长且顺应性低，带瓣膜支架固定性较好，不容易出现瓣膜移位。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果。
附图说明
图1是心脏解剖结构示意图；图中1为上腔静脉，2为下腔静脉，3为右心房，4为三尖瓣，5为右心室，6为肺动脉瓣，7为肺动脉，8为肺静脉，9为左心房，10为二尖瓣，11为左心室，12为主动脉瓣，13为主动脉，14为降主动脉，15为含氧血流向，16为缺氧血流向。
图2是本发明的一个优选实施例的第一形态立体结构示意图；
图3是图1所示实施例的俯视结构示意图。
具体实施方式
如图2和图3所示为本发明的一个优选实施例的第一形态的结构示意图。
该用于治疗三尖瓣反流的异位植入瓣膜支架系统包括支架1、人工瓣膜2和覆膜3。其中，支架1为圆柱形管状，且具有网格结构，如图1所示所述网格的网孔形状为菱形。该网孔形状不唯一，任意能满足血流流通和收缩扩张要求的形状都是可行的。
从图2中可见，人工瓣膜2被垂直于支架轴向地缝制在支架1的内部，形成一个横截面，该人工瓣膜具有三个半月窦状的瓣膜，其边缘可完全闭合。从图1中可见覆膜3覆盖了支架1自上端向下的1/3高度的外表面，用于防止瓣周漏的发生，而人工瓣膜2则被设置在距上端1/3高度处，图中所示的上端在该支架系统被植入人体时是作为近心端使用的。
本实施例中的支架系统根据患者的实际情况，内径可设计为20-40mm，长度可设计为40-60mm，人工瓣膜2可由猪或牛心包制成，覆膜3可由聚乙烯材料制成，支架1可由具有强回复力的弹性合金材料制成，如镍钛合金等。
该系统可在扩张的第一形态和收缩的第二形态之间变换，第一形态为该系统被植入人体上腔静脉或下腔静脉后的工作形态，第二形态为该系统被经导管输送时的输送形态。本实施例采用自膨胀或者球囊扩张膨胀的原理，在体外，该装置可以被压迫成条状的第二形态，放置于输送装置中，到达上腔静脉或下腔静脉预定位置后，通过自膨胀或者球囊扩张，可以恢复到原始设计的形态且具有较高的硬度，并牢牢固定于上、下腔静脉内。
本实施例的用于治疗三尖瓣反流的异位植入瓣膜支架系统的制作方法优选为激光雕刻技术。但该制备方法不唯一，在其它的优选实施方式中也可以采用一体成型的3D打印技术制作。
本发明的异位植入瓣膜支架系统在实际植入时可采用以下步骤：
(1)在体外，使用压迫器械，将所述支架系统迫成细条状后，再将其置入输送装置的鞘管中；
(2)将导丝放入腔静脉，沿着导丝将装有支架系统的输送鞘管分别送至上、下腔静脉内；
(3)后撤输送鞘管，打开该支架系统；
(4)完全释放该支架系统，退出输送装置。
上述植入步骤以及植入后不会影响影响心脏组织结构，不影响上、下腔静脉分支的血流。
以上详细描述了本发明的较佳具体实施例。应当理解，本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。
Claims (2)
1.一种用于治疗三尖瓣反流的异位植入瓣膜支架系统，其特征在于包括支架、人工瓣膜和覆膜，所述支架为管状，且具有网格结构，内径为20-40mm，长度为40-60mm，所述人工瓣膜被垂直于支架轴向地缝制在所述支架的内部距所述支架近心端1/2-1/4高度处，所述覆膜覆盖所述支架从近心端至距近心端1/2-1/4高度处的外周表面；所述支架由具有强回复力的弹性合金材料制成，所述支架的网格结构的网孔形状为菱形，孔眼的最大径向长度在4mm以上；所述人工瓣膜由猪或牛心包制成，所述覆膜由高分子材料制成；所述瓣膜支架系统可在径向扩张的第一形态和径向收缩的第二形态之间变换；其中，所述第一形态为所述瓣膜支架系统被植入人体上腔静脉或下腔静脉后的工作形态，所述第二形态为所述瓣膜支架系统被经导管输送时的输送形态；所述瓣膜支架系统由激光雕刻技术或一体成型的3D打印技术制成。
2.如权利要求1所述的用于治疗三尖瓣反流的异位植入瓣膜支架系统，其特征在于所述瓣膜支架系统包括上腔静脉瓣膜支架系统和下腔静脉瓣膜支架系统，且前述的一对上下腔静脉瓣膜支架系统分别独立或通过连接部件一体化连接。
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