CN111887924A - 一种血栓阻断器 - Google Patents

一种血栓阻断器 Download PDF

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CN111887924A
CN111887924A CN202010884337.9A CN202010884337A CN111887924A CN 111887924 A CN111887924 A CN 111887924A CN 202010884337 A CN202010884337 A CN 202010884337A CN 111887924 A CN111887924 A CN 111887924A
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thrombus
traction
expansion body
elastic expansion
rod
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谢欣
王学成
石丽雅
吴奕章
周建
余金波
李小荣
周晓茜
李金海
杨兵
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Shanghai East Hospital Tongji University Affiliated East Hospital
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Abstract

本发明为一种血栓阻断器。它包括由金属丝构成的中空的弹性膨隆体,所述弹性膨隆体的顶部设有若干个可聚拢瓣叶,所述弹性膨隆体的底部连有柔性牵拉套管,所述牵拉套管内设有柔性牵拉杆,所述柔性牵拉杆的顶部设有若干根分别与所述可聚拢瓣叶的顶部相连的牵引丝;所述柔性牵拉杆的底部伸出所述牵拉套管。

Description

一种血栓阻断器
技术领域
本发明涉及一种医疗过程中置于血管内的防阻塞装置,特别是公开一种血栓阻断器。
背景技术
心房颤动,简称房颤,是临床上最常见的可持续性心律失常,在人群中的发病率可达1%~2%,随着老龄化社会的到来其发病率亦将逐渐增高。房颤主要的危害包括生活质量降低、心功能恶化及血栓栓塞等。目前的主要治疗措施包括药物治疗,射频消融治疗,左心耳封堵预防血栓等。
房颤所导致的血栓栓塞相对于一般卒中,其致死率要高一倍,复发率高近50%。其中神经科就诊的急性脑卒中患者,有20-30%为房颤所导致的心源性卒中。
对于急性发作的房颤引起的心源性卒中,指南推荐根据脑卒中的严重程度,须停用抗凝药物一段时间。期间患者往往面临极高的再栓塞风险。而因左心耳内血栓,左心耳封堵、切除等操作均难以实施。
所以临床迫切需要一种可以从根源上防止左心耳血栓脱落、再次栓塞的预防措施。
发明内容
本发明的目的在于解决现有技术中存在的问题,提供一种可以阻止由心脏产生的血栓向全身播散、避免血管再次梗塞的血栓阻断器。
本发明是这样实现的:一种血栓阻断器,包括由金属丝构成的中空的弹性膨隆体,所述弹性膨隆体的顶部设有若干个可聚拢瓣叶,所述弹性膨隆体的底部连有柔性牵拉套管,所述牵拉套管内设有柔性牵拉杆,所述柔性牵拉杆的顶部设有若干根分别与所述可聚拢瓣叶的顶部相连的牵引丝;所述柔性牵拉杆的底部伸出所述牵拉套管。
所述弹性膨隆体上设有半透膜或网片层。
所述弹性膨隆体包括相互连接的纵向支撑杆和横向弹性伸缩杆,所述横向弹性伸缩杆的轴线呈横向的“S”形曲线,所述纵向支撑杆的轴线呈外凸的弧线,所述纵向支撑杆的顶部与所述可聚拢瓣叶的底部相连。
所述可聚拢瓣叶呈椭圆形或叶形,所述可聚拢瓣叶的顶部为钝部。
所述弹性膨隆体的底部设有固定座,所述固定座与所述牵拉套管的顶部相连,所述柔性牵拉杆的顶部或牵引丝穿过所述固定座。
所述柔性牵拉杆的尾部设有牵拉手柄。
还包括套设在所述弹性膨隆体和可聚拢瓣叶外部的约束套。
所述可聚拢瓣叶的数量为6~12个。
所述金属丝为记忆金属丝。
本发明的有益效果是:所述弹性膨隆体用于支撑在血管内,中间呈中空状,用于拦截和收集血栓,所述可聚拢瓣叶在自然状态性呈顶部开放状态,通过所述柔性牵拉杆拉动所述牵引丝并带动所述可聚拢瓣叶收拢、重叠,防止弹性膨隆体内的血栓逃逸;所述弹性膨隆体在外部作用力下可向内发生弹性形变,通过约束套可以将收缩后的弹性膨隆体约束在约束套内,方便存放和运输。本发明使用方便,可以有效阻断和收集血栓,避免血管发生阻塞。
附图说明
图1是本发明结构示意图。
图2是本发明弹性膨隆体和可聚拢瓣叶的俯视结构示意图。
图3是本发明约束套套在所述弹性膨隆体和可聚拢瓣叶上时的结构示意图。
其中:1、弹性膨隆体;2、可聚拢瓣叶;3、牵拉套管;4、柔性牵拉杆;5、牵引丝;6、牵拉手柄;7、固定座;8、半透膜;9、纵向支撑杆;10、横向弹性伸缩杆;11、约束套。
具体实施方式
根据图1~3,本发明包括由金属丝构成的中空的弹性膨隆体1,所述金属丝优选为记忆金属丝,优选镍钛合金金属丝。所述弹性膨隆体1的顶部设有若干个可聚拢瓣叶2,所述可聚拢瓣叶2的数量为6~12个,优选8个。所述可聚拢瓣叶2呈椭圆形或叶形,所述可聚拢瓣叶2的顶部为钝部。所述弹性膨隆体1的底部连有柔性牵拉套管3,所述牵拉套管3内设有柔性牵拉杆4,所述柔性牵拉杆4的顶部设有若干根分别与所述可聚拢瓣叶2的顶部相连的牵引丝5;所述柔性牵拉杆4的底部伸出所述牵拉套管3。所述柔性牵拉杆4的尾部设有牵拉手柄6。所述弹性膨隆体1的底部固定在固定座7上,所述固定座7与所述牵拉套管3的顶部相连,所述柔性牵拉杆4的顶部或牵引丝5穿过所述固定座7。所述弹性膨隆体1上设有半透膜8或网片层。
所述弹性膨隆体1包括相互连接的纵向支撑杆9和横向弹性伸缩杆10。所述横向弹性伸缩杆10的轴线呈横向的“S”形曲线,使得横向弹性伸缩杆10在压缩时不容易发生破坏,兼具支承和压缩性能;所述纵向支撑杆9的轴线呈外凸的弧线,所述纵向支撑杆9的顶部与所述可聚拢瓣叶2的底部相连。所述弹性膨隆体1和可聚拢瓣叶2的外部套设有约束套11。所述弹性膨隆体1在外部作用力下可向内发生弹性形变、形成压缩状,通过所述约束套11可以将收缩后的弹性膨隆体1约束在约束套内,方便存放和运输。
所述可聚拢瓣叶2与所述弹性膨隆体1连为一体,在没有外力牵拉所述柔性牵拉杆4时,所述可聚拢瓣叶2呈张开状态,当血栓收集后,通过所述柔性牵拉杆4拉动所述牵引丝5并带动所述可聚拢瓣叶2收拢、重叠,在牵引丝5的牵引下,所述可聚拢瓣叶2头端可顺牵引丝牵引,可聚拢瓣叶2头端向内汇聚,呈荷包样收拢。收拢过程中,可聚拢瓣叶2之间贴合、重叠,防止已经收集的血栓逃逸。
本发明使用时,建立动脉途径,置入导丝至主动脉根部。沿导丝送入递送鞘管至主动脉根部,撤出导丝,经递送鞘管造影确认位置,并核实其开口位于目标血栓阻断区域。递送鞘管的头端位置须早于头臂干开口。经递送鞘管送入猪尾导管导丝,经猪尾导管导丝送入猪尾导管至升主动脉根部,撤出导丝,经猪尾导管造影确认冠状动脉开口,确保递送鞘管和冠状动脉开口之间的距离大于本发明阻断器的长度,防止本发明阻断器损伤、阻塞冠状动脉。
本发明阻断器的弹性膨隆体1在体外呈收缩状态,其由外部包绕的约束套11约束,防止体外张开。经约束套11与递送鞘管对接后,将弹性膨隆体1脱离约束套11、经递送鞘管送至目标血栓阻断区域。所述弹性膨隆体1采用记忆金属丝,在出递送鞘管后逐步张开,所述弹性膨隆体1和可聚拢瓣叶2贴靠于主动脉壁。记忆金属丝可以随温度的变化而产生形状的变化,在记忆温度上恢复原本形态,例如,本发明弹性膨隆体1在进入血管后,在温度达到人体温度时,性膨隆体1呈原始形态而具有较难以形变的能力。通过冷盐水灌注降低弹性膨隆体1温度时,由于温度的下降,弹性膨隆体1易变柔软,增加可塑形性能。所述记忆金属本身为成熟的现有技术,对其本身的原理不做赘述,本发明将记忆金属丝作为优选例是对记忆金属的一种应用。
所述半透膜8优选PET编织而成的目数为140-200微米的PET编织半透膜,所述半透膜8不阻断血流,但会阻断血流中的血栓。在本发明阻断器的弹性膨隆体1位于主动脉根部的时间内须持续抗凝,防止血栓形成。须密切监测血压及其他生命体征。
在本发明阻断器在位时,因由心脏脱落的血栓均会被所述弹性膨隆体1收集。故可进行心脏内其他手术操作,例如左心耳封堵术、射频消融术等。
在心脏内其他操作完成后,可将本发明阻断器回收。经递送鞘管注入冷盐水,使阻断器金属可塑性增加。适当回拉柔性牵拉杆,牵拉可聚拢瓣叶头端向内聚拢、包裹,可聚拢瓣叶之间彼此覆盖、重叠,充分将收集到的血栓包裹于阻断器内。确认包裹后,须术者手握牵拉杆并保持一定压力,确保瓣叶不会回弹、张开。
确认头端结构包裹完成后,将柔性牵拉杆和牵拉套管一同回拉,将弹性膨隆体和可聚拢瓣叶整体拉入递送敲管中。
最后,撤出本发明阻断器和递送鞘管。

Claims (9)

1.一种血栓阻断器,其特征在于:包括由金属丝构成的中空的弹性膨隆体,所述弹性膨隆体的顶部设有若干个可聚拢瓣叶,所述弹性膨隆体的底部连有柔性牵拉套管,所述牵拉套管内设有柔性牵拉杆,所述柔性牵拉杆的顶部设有若干根分别与所述可聚拢瓣叶的顶部相连的牵引丝;所述柔性牵拉杆的底部伸出所述牵拉套管。
2.根据权利要求 1 所述的一种血栓阻断器,其特征在于:所述弹性膨隆体上设有半透膜或网片层。
3.根据权利要求 1 所述的一种血栓阻断器,其特征在于:所述弹性膨隆体包括相互连接的纵向支撑杆和横向弹性伸缩杆,所述横向弹性伸缩杆的轴线呈横向的“S”形曲线,所述纵向支撑杆的轴线呈外凸的弧线,所述纵向支撑杆的顶部与所述可聚拢瓣叶的底部相连。
4.根据权利要求 1 所述的一种血栓阻断器,其特征在于:所述可聚拢瓣叶呈椭圆形或叶形,所述可聚拢瓣叶的顶部为钝部。
5.根据权利要求 1 所述的一种血栓阻断器,其特征在于:所述弹性膨隆体的底部设有固定座,所述固定座与所述牵拉套管的顶部相连,所述柔性牵拉杆的顶部或牵引丝穿过所述固定座。
6.根据权利要求 1 所述的一种血栓阻断器,其特征在于:所述柔性牵拉杆的尾部设有牵拉手柄。
7.根据权利要求 1 所述的一种血栓阻断器,其特征在于:还包括套设在所述弹性膨隆体和可聚拢瓣叶外部的约束套。
8.根据权利要求 1 所述的一种血栓阻断器,其特征在于:所述可聚拢瓣叶的数量为6~12个。
9.根据权利要求 1 所述的一种血栓阻断器,其特征在于:所述金属丝为记忆金属丝。
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