CN105769383B - 一种主动脉裸支架及主动脉夹层支架 - Google Patents

一种主动脉裸支架及主动脉夹层支架 Download PDF

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Publication number
CN105769383B
CN105769383B CN201610158220.6A CN201610158220A CN105769383B CN 105769383 B CN105769383 B CN 105769383B CN 201610158220 A CN201610158220 A CN 201610158220A CN 105769383 B CN105769383 B CN 105769383B
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China
Prior art keywords
stent
connector
bare
support
aortic
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CN201610158220.6A
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CN105769383A (zh
Inventor
王永胜
符伟国
张庭超
林曼卿
张明瑜
其他发明人请求不公开姓名
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Hangzhou Wei Qiang Medical Technology Co ltd
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Hangzhou Strong Medical Technology Co Ltd
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Priority to CN201910900601.0A priority Critical patent/CN110742709B/zh
Priority to CN201610158220.6A priority patent/CN105769383B/zh
Publication of CN105769383A publication Critical patent/CN105769383A/zh
Priority to US16/084,264 priority patent/US10799375B2/en
Priority to PCT/CN2017/076942 priority patent/WO2017157320A1/zh
Priority to EP17765862.2A priority patent/EP3421009A4/en
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Publication of CN105769383B publication Critical patent/CN105769383B/zh
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明公开了一种主动脉裸支架及主动脉夹层支架，其中，主动脉裸支架为管状的网络结构，沿轴向排布有多圈支撑体支架，相邻的两圈支撑体支架之间通过连接体支架相连接，所述连接体支架采用超弹性材料，连接体支架的抗弯刚度小于支撑体支架的抗弯刚度。所述支撑体支架采用单股的超弹性镍钛丝制成或采用镍钛管材切割而成。所述连接体支架采用多股复合丝制成，多股复合丝由多股丝捻绕或者编织构成，其中每股丝各自独立地采用镍钛材质。本发明提供的主动脉裸支架，具有适宜的径向支撑强度、轴向支撑强度、以及良好的弯曲柔顺性，在释放时，易于弯曲顺应血管的形态，减小对血管壁的压迫。

Description

一种主动脉裸支架及主动脉夹层支架
技术领域
本发明涉及医疗器械领域，具体涉及一种主动脉裸支架及主动脉夹层支架。
背景技术
人体主动脉血管由3层膜结构组成，分别为内膜、中膜和外膜，3层膜结构紧密贴合，共同承载血流的通过。
主动脉夹层是指：由于内膜局部撕裂，受到强有力的血液冲击，内膜逐步剥离、扩展，在动脉内形成真、假两腔。主动脉夹层是严重威胁人类生命健康的心血管疾病，总体发病率为5/10万左右，病死率约为1.5/10万。
Stanford分型方法是主动脉夹层分型中较为常用的一种，分为A型和B型两种，其中Standford A型是指夹层累及到升主动脉和(或)主动脉弓的夹层；Standford B型是指夹层仅限于胸降主动脉的夹层。
Standford A型夹层因为病变位置的特殊解剖结构，目前主要还是采用传统外科手术治疗；Standford B型夹层目前主要采用腔内介入治疗，并且近几年得到了非常快速的发展。
发明内容
本发明提供了一种主动脉裸支架，具有适宜的径向支撑强度、轴向支撑强度、以及良好的弯曲柔顺性，在释放时，易于弯曲顺应血管的形态，减小对血管壁的压迫。
一种主动脉裸支架，为管状的网络结构，沿轴向排布有多圈支撑体支架，相邻的两圈支撑体支架之间通过连接体支架相连接，所述连接体支架采用超弹性材料，连接体支架的抗弯刚度小于支撑体支架的抗弯刚度。
所述支撑体支架的抗弯刚度大于连接体支架的抗弯刚度，支撑体支架保证主动脉裸支架在径向具有足够的支撑强度，连接体支架保证主动脉裸支架具有良好的弯曲柔顺性，同时也能够起到轴向支撑的作用。
所述支撑体支架和连接体支架均为自膨式支架，在自然伸展状态下，由于支撑体支架和连接体支架都具有一定的抗弯刚度，能够维持主动脉裸支架的直管状形态。
本发明提供的主动脉裸支架受到外部应力，发生弯曲时，连接体支架自身发生形变，以适应主动脉裸支架的整体弯曲，外部应力消失后，连接体支架能够恢复初始形状，即主动脉裸支架变回自然伸展状态下的直管状。
本发明中支撑体支架和连接体支架的作用不同，支撑体支架主要用于提供径向的支撑作用，能够与血管很好地抵靠贴合，连接体支架则一方面需要维持主动脉裸支架的直管状形态，另一方面还需要在外力作用下易于发生形变，使主动脉裸支架具有良好的柔顺性。
由于支撑体支架和连接体支架的作用不同，抗弯刚度也不同，优选地，连接体支架与支撑体支架的抗弯刚度之比为0.5～20：100。
连接体支架和支撑体支架的抗弯刚度难以分别测量，由于连接体支架和支撑体支架在形状上具有相似性，因此，连接体支架和支撑体支架的抗弯刚度可利用各自的材料性能进行衡量。
本发明中连接体支架的抗弯刚度定义为：全部采用连接体支架的材质制作得到的主动脉裸支架的抗弯刚度；支撑体支架的抗弯刚度为：全部采用支撑体支架的材质制作得到的主动脉裸支架的抗弯刚度。
进行支撑体支架和连接体支架抗弯刚度比较时，主动脉裸支架的结构参数相同，例如，径向尺寸，轴向长度等，但不包括材质自身的横截面积等属于材质自身性质的内容。
作为优选，所述支撑体支架采用单股的超弹性镍钛丝制成或采用镍钛管材切割而成。
支撑体支架采用现有技术中的超弹性镍钛丝制作而成，为了保证支撑体支架具有合适的抗弯刚度。
抗弯刚度反应了结构抵抗弯曲变形的能力，材料力学中结构的抗弯刚度计算公式为：EI，其中E为材料弹性模量，为常数；I为材料的截面惯性矩，圆形截面惯性矩I为πd4/64，d为丝径(本发明中如无特殊说明，丝径均指镍钛丝横截面的直径)。因此，采用相同的镍钛丝材料，抗弯刚度跟丝径的四次方成正比，镍钛丝的丝径越小，抗弯刚度就越小，所允许的弯曲变形越大。例如，丝径为0.3mm的镍钛丝弯曲刚度是丝径为0.07mm镍钛丝弯曲刚度的337倍。
优选地，制作支撑体支架的超弹性镍钛丝的直径为0.2～0.45mm。进一步优选，制作支撑体支架的超弹性镍钛丝的直径为0.3～0.4mm。最优选，制作支撑体支架的超弹性镍钛丝的直径为0.3mm。
作为优选，所述连接体支架采用多股复合丝制成，多股复合丝由多股丝捻绕或者编织构成，其中每股丝各自独立地采用镍钛材质或高分子材料。
作为优选，多股复合丝中的每股丝均采用超弹性镍钛丝。相对于相同直径的单一镍钛丝而言，多股镍钛丝既允许有较大的弯曲变形量来增加主动脉裸支架的弯曲柔顺性，也具有一定的强度，保证主动脉裸支架的径向和轴向支撑性能。
多股复合丝中至少具有一根超弹性镍钛丝，其余股丝可以采用超弹性高分子纤维、高分子缝线或混合编织的高分子缝线，例如PET缝线、PP缝线等。
作为优选，多股复合丝由2～7股丝捻绕或者编织构成。例如，多股复合丝采用3股丝捻绕或者编织构成。或，多股复合丝采用4股丝捻绕或者编织构成。或，多股复合丝采用5股丝捻绕或者编织构成。或，多股复合丝采用6股丝捻绕或者编织构成。
连接体支架的抗弯刚度依赖于连接体支架的结构，以及制作连接体支架的材质，连接体支架的材质采用多股复合丝，多股复合丝中每股丝的丝径均会影响连接体支架的抗弯刚度，为了获得合适的抗弯刚度，优选地，多股复合丝中每股丝的直径为0.05～0.2mm。进一步优选，多股复合丝中每股丝的直径为0.07～0.10mm。再优选，多股复合丝中每股丝的直径为0.07～0.08mm。最优选，多股复合丝中每股丝的直径为0.07mm。
作为优选，多股复合丝采用3股超弹性镍钛丝捻绕而成，且每股超弹性镍钛丝的丝径为0.07mm。
作为优选，多股复合丝采用3股超弹性镍钛丝编织而成，且每股超弹性镍钛丝的丝径为0.07mm。
若多股复合丝采用超弹性镍钛丝捻绕而成，捻绕后的多股超弹性镍钛丝(横截面的外接圆的直径)的小于等于支撑体支架的丝径。作为优选，捻绕后的多股超弹性镍钛丝的丝径为0.15mm。
本发明提供的主动脉裸支架在自然伸展状态下为直管状，在体内释放后，会发生弯曲，沿直管状的长度方向等径或者变径延伸，以顺应血管的形态。
作为优选，每圈支撑体支架独立成环，且每圈支撑体支架在周向延伸的同时，沿轴向起伏成波浪状。各圈支撑体支架的结构均相同，且相邻两圈支撑体支架之间波峰对齐。
作为优选，以相邻支撑体支架邻近波峰、波谷为连接点，所述连接体支架与相邻两圈支撑体支架上的相应连接点相连。
利用一圈连接体支架连接相邻两圈支撑体支架，作为优选，每圈连接体支架独立成环，且每圈连接体支架在周向延伸的同时，沿轴向起伏成波浪状，并与延伸路径两侧的每个连接点相连构成封闭网格结构。
将主动脉裸支架竖直放置，连接体支架的波峰与相邻的上一圈支撑体支架的波谷相连，连接体的波谷与相邻的下一圈支撑体支架的波峰相连。
封闭网格结构以菱形作为单元网格，连接体支架的波峰和波谷、支撑体支架的波峰和波谷均作为连接点。
作为优选，每圈连接体支架独立成环，且每圈连接体支架在周向延伸的同时，沿轴向起伏成波浪状，连接体支架延伸路径两侧的部分波峰波谷作为连接点与连接体支架相连构成开环的网格结构。
连接体支架延伸路径两侧的支撑体支架的波峰波谷并非都作为连接点，也即支撑体支架的部分波峰和波谷孤立存在，不与连接体支架相连。
进一步优选，每圈连接体支架独立成环，且每圈连接体支架在周向延伸的同时，沿轴向起伏成波浪状，连接体支架延伸路径两侧的波峰波谷间隔作为连接点与连接体支架相连构成开环的网格结构。
每个连接体支架延伸路径两侧的波峰和波谷，划分为作为连接点的波峰、不作为连接点的波峰、作为连接点的波谷、和不作为连接点的波谷，作为连接点的波峰和不作为连接点的波峰间隔分布，作为连接点的波谷和不作为连接点的波谷间隔分布。
本发明提供的主动脉裸支架中，支撑体支架和连接体支架间隔排列，且裸支架的两端均为支撑体支架。每圈支撑体支架的波峰波谷数量相同，连接体支架的波峰波谷数量相同，且支撑体支架和连接体支架的波峰波谷数量相同。
为了保证主动脉裸支架整体的径向支撑强度，支撑体支架的轴向长度不小于连接体支架的轴向长度，优选地，连接体支架与支撑体支架的轴向长度之比为1：1～2.5。进一步优选，连接体支架与支撑体支架的轴向长度之比为1：1.5～2。
除了支撑体支架和连接体支架独立成环的形式，主动脉裸支架还可以为其他结构形式，例如，除首尾位置外，其余位置的支撑体支架为开环结构，且相邻支撑体支架之间首尾衔接呈螺旋状。
以支撑体支架环绕周向360度为一圈，相邻两圈支撑体支架之间由连接体支架相连接，连接体支架整体亦呈现螺旋状。
作为优选，所述连接体支架与对应的连接点采用缠绕或打结的方式相连。
所述连接体支架与对应的连接点之间相对固定连接，即在主动脉裸支架整体发生弯曲时，连接体支架自身会发生变形，但是连接体支架与支撑体支架在连接点处不会发生相对滑动。
为了避免主动脉裸支架轴向压缩长度过长，优选地，还包括至少一条轴向连接体，每条轴向连接体通过打结或缠绕的方式与支撑体支架上对应的连接点相连。
每条轴向连接体沿主动脉裸支架的母线延伸，每条轴向连接体与相接触的所有或者部分支撑体支架相连。
由于各圈支撑体支架的波峰(或波谷)对齐，每条轴向连接体依次与位于裸支架同一母线上的波峰(或波谷)连接。
作为优选，多条轴向连接体沿主动脉裸支架的周向均匀分布。
为了适应不同血管的特殊需求，本发明提供的主动脉裸支架可以为非等径延伸的管状，例如，主动脉裸支架为锥管状，或主动脉裸支架为锥管状与直管状组成的变径结构。
为了实现主动脉裸支架的非等径延伸管状结构，本发明中各圈支撑体支架具有不同的结构，例如，部分支撑体支架采用封闭的环形结构，部分支撑体支架采用网状结构，各圈支撑体支架的轴向长度并非完全一致。各圈连接体支架适应于支撑体支架也可以具有不同的结构。
本发明还提供了一种主动脉夹层支架，包括相互对接的覆膜支架和裸支架，所述裸支架为所述的主动脉裸支架。
所述覆膜支架用于封堵血管B型夹层近端破口，降低假腔内压力，并促使假腔内血栓化，裸支架放置于覆膜支架的远端，用于重塑血管真腔，并保证各内脏动脉血流通畅。
所述覆膜支架和裸支架的对接部分相互嵌套，即至少有一部分为重叠区域。所述重叠区域的轴向长度依据需要进行设置。
本发明提供的主动脉裸支架，具有适宜的径向支撑强度、轴向支撑强度、以及良好的弯曲柔顺性，在释放时，易于弯曲顺应血管的形态，减小对血管壁的压迫。
附图说明
图1为实施例1主动脉裸支架示意图；
图2a为实施例1主动脉裸支架的支撑体支架的示意图；
图2b为实施例1主动脉裸支架的连接体支架的示意图；
图3a为实施例1夹层裸支架的多股镍钛丝结构示意图；
图3b为图3a中的A部放大图；
图4为实施例1支撑体支架与连接体支架连接的结构示意图；
图5a、图5b、图5c、图5d为实施例1支撑体支架与连接体支架缠绕固定的连接方式示意图；
图6为实施例2夹层裸支架示意图；
图7a、图7b、图7c、图7d、图7e为实施例2支撑体支架与连接体支架打结固定连接方式示意图；
图8a、图8b、图8c、图8d、图8e为实施例3环状支撑体支架与环状连接体支架另一打结固定连接方式示意图；
图9为实施例4夹层裸支架示意图；
图10为实施例5夹层裸支架示意图；
图11a为实施例6夹层裸支架的主视图；
图11b为实施例6夹层裸支架的后视图；
图12为实施例7夹层裸支架的示意图；
图13为实施例8夹层裸支架的示意图；
图14为实施例9夹层裸支架的示意图；
图15为实施例2主动脉裸支架用于主动脉夹层治疗示意图；
图16为实施例10夹层裸支架的示意图。
具体实施方式
下面结合附图和实施例对本发明进行详细说明。文中所述近端是指靠近心脏位置的一端，所述远端为远离心脏位置的一端。各实施例的示意图中，上方为近端，下方为远端。
实施例1
如图1所示，主动脉裸支架100由多圈环状的支撑体支架110和多圈环状的连接体支架120组成，主动脉裸支架100整体为管状的网络结构，各圈支撑体支架110的结构相同，各圈连接体支架120的结构也相同。
多圈环状的支撑体支架110从主动脉裸支架100的近端到远端依次平行间隔排布，每两圈相邻的支撑体支架110之间具有一圈连接体支架120，即支撑体支架110和连接体支架120沿主动脉裸支架100的轴向间隔分布。本实施例中支撑体支架110和连接体支架120的直径相同，直径均为30mm，即主动脉裸支架100的管状直径为30mm。
如图2a所示，每圈支撑体支架110沿主动脉裸支架100的周向延伸，形成封闭的环状，并且在周向延伸的同时，沿主动脉裸支架100的轴向起伏，形成波浪状。
波浪状为正弦波状(或余弦波状)，波浪状具有多个间隔分布的波峰111和波谷112，相邻的波峰111和波谷112之间由连接杆113连接，波峰111的数量为12个，波谷112的数量也为12个，每圈支撑体支架110的轴向长度为8mm。
每圈支撑体支架110采用一根超弹性镍钛丝编织而成，镍钛丝的丝径较细，在0.2～0.4mm之间。本实施例中的支撑体支架110采用0.3mm直径的超弹性镍钛丝编织而成。
如图2a所示，每圈支撑体支架110上设有1个连接钢套114，超弹性镍钛丝的两个端点处在连接钢套114内部，并通过机械压紧或者焊接方式将超弹性镍钛丝的两个端点固定在钢套内部。
相对于传统的主动脉覆膜支架的编织方式，本实施例采用了更细丝径的超弹性镍钛丝来编织支撑体支架，并且每圈支撑体支架的正弦波的波峰和波谷数量更多，使整体的主动脉裸支架100在圆周方向的支撑力分布更均匀，柔顺性更好，更能满足夹层病例的需求。
如图2b所示，每圈连接体支架120沿主动脉裸支架100的周向延伸，形成封闭的环状，并且在周向延伸的同时，沿主动脉裸支架100的轴向起伏，形成波浪状。
波浪状为正弦波状(或余弦波状)，波浪状具有多个间隔分布的波峰121和波谷122，相邻的波峰121和波谷122之间由连接杆123连接，波峰121的数量为12个，波谷122的数量也为12个，每圈连接体支架120的轴向长度为4.5mm。
每圈连接体支架120采用1条多股镍钛丝编织而成，多股镍钛丝由不少于3根超弹性镍钛细丝通过机械捻绕或者编织在一起形成，多股镍钛丝的丝径在0.1～0.4mm之间。
如图3a、图3b所示，本实施例中，多股镍钛丝为3股超弹性镍钛单丝捻绕而成，3股超弹性镍钛单丝分别为超弹性镍钛丝1201、超弹性镍钛丝1202、和超弹性镍钛丝1203，3股超弹性镍钛单丝的丝径相同，每股超弹性镍钛单丝的丝径为0.07mm，捻绕形成的多股镍钛丝的丝径(横截面的外接圆的直径)为0.15mm，编织而成的连接体支架120如图2b所示。
制作每圈连接体支架120的多股镍钛丝的两个端部通过打结、焊接或者加钢套的方式连接在一起，本实施例中采用打结方式固定在一起。
如图4所示，两圈相邻的支撑体支架110之间由一圈连接体支架120相连接，两圈相邻的支撑体支架110的波峰对齐排布(波谷也对齐排布)，每圈连接体支架120的波峰121和相邻上一圈支撑体支架110的波谷112连接在一起，每圈连接体支架120的波谷122和相邻下一圈支撑体支架110的波峰111连接在一起，所有支撑体支架110和连接体支架120整体组合成一管状的主动脉裸支架100，管状的周面为具有菱形网格的网络结构。
本实施例的主动脉裸支架100由11圈支撑体支架110及10圈连接体支架120连接闭合而成，轴向总长度为133mm。
本实施例提供的主动脉裸支架100在周向外表面具有均匀合理且较小的支撑力，既能够避免因径向力过大产生新的夹层破口的问题，又能够保证主动脉裸支架100具有良好的弯曲柔顺性，能够适应各种形态的主动脉解剖结构。
本实施例提供的主动脉裸支架100在轴向上具有较好的轴向支撑性能，避免支架发生堆积短缩。
另外，本实施例提供的主动脉裸支架100采用闭环设计，能够避免出现开环连接产生的单圈支架翻转或开环波峰刺伤血管壁的问题。
如图1、图4所示，每圈连接体支架120的单个波峰121或者波谷122和对应的支撑体支架110的单个波谷112或者波峰111固定连接在一起，连接体支架120和支撑体支架110之间没有相对移动。
本实施例中，每圈连接体支架120在波峰或者波谷的位置通过缠绕方式固定在对应的支撑体支架110的波谷或者波峰上，缠绕连接的过程如图5a～图5b所示，连接体支架120连接相邻的两圈支撑体支架110，连接体支架120与上一圈支撑体支架110的波谷112连接时，多股镍钛丝的头端124由波谷112外侧穿入(外侧是指主动脉裸支架的外侧，下文中外侧和内侧如无特殊说明，均做相同解释)，绕过波谷112后，头端124朝向下一圈支撑体支架110穿出，如图5a所示。
按照图5a方式将多股镍钛丝缠绕支撑体支架110波谷3～5圈，如图5b所示，本实施例缠绕3圈，完成一个连接体支架120的波峰与支撑体支架110的波谷112的缠绕固定连接。
然后，镍钛丝的头端124从相邻的下一圈支撑体支架110相邻波峰111的外侧穿入，绕过波峰111后，头端124朝向上一圈支撑体支架110穿出，如图5c所示。
按照图5c方式将多股镍钛丝缠绕支撑体支架110波峰3～5圈，如图5d所示，本实施例缠绕3圈，完成一个连接体支架120的波谷与支撑体支架110的波峰111的缠绕固定连接。
实施例2
如图6所示，本实施例中主动脉裸支架200由多圈支撑体支架210和多圈连接体支架220组成，本实施例与实施例1之间的区别仅在于，支撑体支架210的波峰或波谷与连接体支架220的波谷或波峰之间的固定方式采用打结方式。
如图7a～图7e所示，本实施例中，每圈连接体支架220在波峰或者波谷的位置通过一打结方式固定在对应的支撑体支架210的波谷或者波峰上。
如图7a所示，多股镍钛丝头端224从上一圈支撑体支架的波谷212内侧穿出，绕过波谷，从镍钛丝自身底部穿过；
如图7b所示，镍钛丝头端224从波谷外侧穿入波谷内侧，多股镍钛丝与支撑体支架210的波谷212之间形成一圆圈225；
如图7c所示，镍钛丝头端224绕过波谷从自身形成的圆圈225穿出，完成一个连接体支架220的波峰221与支撑体支架210的波谷212的打结固定连接。
如图7d、7e所示，镍钛丝头端224从下一圈支撑体支架210相邻波峰211内侧穿出，按照连接体支架220的波峰221与支撑体支架210的波谷212的打结固定方式完成连接体支架220的波谷222与相邻下一圈支撑体支架210的波峰211的打结固定连接。
本实施例提供的主动脉裸支架200联合近端覆膜支架10治疗主动脉B型夹层的示意图如图15所示，图2中，a为血管近端破口，b为假腔，c为覆膜支架10和主动脉裸支架200的重叠区域。
近端覆膜支架10将B型夹层近端破口封堵，降低假腔内的压力，并促使假腔内血栓化；主动脉裸支架200放置于覆膜支架远端，与覆膜支架10部分重叠，用于重塑血管真腔，并且保证各内脏动脉血流通畅。
实施例3
本实施例与实施例2之间的区别仅在于，连接体支架220和支撑体支架210之间的打结固定方式不同。
如图8a～8e所示，本实施例每圈连接体支架220在波峰或者波谷的位置通过另一打结方式固定在对应支撑体支架210的波谷或者波峰上。
如图8a所示，多股镍钛丝头端224从上一圈支撑体支架210的波谷212外侧穿入，绕过波谷，从镍钛丝自身顶部穿过；
如图8b所示，镍钛丝头端224从波谷内侧穿出至波谷外侧，多股镍钛丝与支撑体支架210之间形成一圆圈226；
如图8c所示，镍钛丝头端224穿过波谷从自身形成的圆圈226穿出，完成一个连接体支架220的波峰221与支撑体支架210的波谷212的打结固定连接；
如图8d、8e所示，镍钛丝头端224从相邻下一圈支撑体支架210相邻波峰211外侧穿入，按照连接体支架220的波峰221与支撑体支架210的波谷212的打结固定方式完成连接体支架220波谷222与相邻下一圈支撑体支架210的波峰211的打结固定。
实施例4
本实施例中主动脉裸支架300与实施例1的区别仅在于，夹层裸支架300除包含多圈支撑体支架310和多圈连接体支架320外，还包含一条或多条轴向连接体330。
轴向连接体330的数量为每圈支撑体支架310波峰数的约数，轴向连接体330在主动脉裸支架300圆周方向均匀分布。每条轴向连接体330通过打结或缠绕的方式连接同一圆柱母线上所有或部分环状的支撑体支架310。
各圈支撑体支架310的波谷312对齐，波峰311也对齐，同一轴向连接体330连接波谷312，或连接波峰311。
轴向连接体330可采用一条多股镍钛丝，也可采用高强度单丝及混合编织高分子缝线，例如PET缝线、PP缝线等。
如图9所示，本实施例设置一条轴向连接体330，采用与环状的连接体支架310相同结构的多股镍钛丝，轴向连接体330依次与近端10圈支撑体支架同一母线上的10个波谷312固定连接，连接方式采用实施例3所示的打结方式。
最远端的一圈支撑体支架310不与轴向连接体330固定连接，不受轴向连接体330的束缚。通过调节相邻两圈支撑体支架310之间轴向连接体330的长度，可避免主动脉裸支架300在装鞘过程中出现轴向过度伸长问题，同时也方便手术释放过程中主动脉裸支架300的精确定位。
实施例5
如图10所示，本实施例中主动脉裸支架400与实施例4的区别仅在于，轴向连接体430与近端10圈支撑体支架410的波谷的连接数量不同。
本实施例中，轴向连接体430仅与第1圈和第10圈支撑体支架410同一母线上的2个波谷312之间通过打结的方式固定，第2圈～第9圈各圈支撑体支架410与轴向连接体430之间没有固定连接。
实施例6
如图11a、图11b所示，本实施例中主动脉裸支架500与实施例4的区别仅在于，本实施例中包含3条轴向连接体530，3条轴向连接体530在主动脉裸支架500的圆周方向均匀分布，每条轴向连接体530与支撑体支架510波谷之间的连接方式与实施例4相同。
实施例7
如图12所示，本实施例中主动脉裸支架600由多圈支撑体支架610和多圈连接体支架620组成。
与实施例1的不同之处仅在于，本实施例中主动脉裸支架600为锥管状结构，近端直径为30mm，远端直径为26mm，主动脉主动脉裸支架的轴向长度为180mm。
实施例8
如图13所示，本实施例中主动脉裸支架700由多圈支撑体支架710和多圈连接体支架720组成。
与实施例2的不同之处仅在于，本实施例中主动脉裸支架700为锥管状结构，近端直径为30mm，远端直径为26mm，主动脉主动脉裸支架的轴向长度为180mm。
实施例9
如图14所示，本实施例中主动脉裸支架800由多圈支撑体支架810和多圈连接体支架820以及一条轴向连接体830组成。
与实施例4的不同之处仅在于，本实施例中主动脉裸支架800为锥管状结构，近端直径为30mm，远端直径为26mm，主动脉主动脉裸支架的轴向长度为180mm。
实施例10
如图16所示，本实施例中主动脉裸支架900由多圈支撑体支架910和多圈连接体支架920组成。
与实施例2的不同之处仅在于，本实施例中支撑体支架910和连接体支架920的连接点不同。
如图16所示，与连接体支架920相邻的上一圈支撑体支架910的波谷中，每两个连接点中间隔一个不作连接点的波谷，同样，与连接体支架920相邻的下一圈支撑体支架910的波峰中，每两个连接点中间隔一个不作连接点的波峰。

Claims (14)

1.一种主动脉裸支架，为管状的网络结构，沿轴向排布有多圈支撑体支架，其特征在于，相邻的两圈支撑体支架之间通过连接体支架相连接，所述连接体支架与支撑体支架之间相对固定连接，所述连接体支架采用多股复合丝制成的超弹性材料，多股复合丝由多股丝捻绕或者编织构成，连接体支架与支撑体支架的抗弯刚度之比为0.5～20：100；连接体支架与支撑体支架的轴向长度之比为1：1～2.5；
所述支撑体支架采用单股的超弹性镍钛丝制成或采用镍钛管材切割而成。
2.如权利要求1所述的主动脉裸支架，其特征在于，多股复合丝中每股丝各自独立地采用镍钛材质。
3.如权利要求1所述的主动脉裸支架，其特征在于，每圈支撑体支架独立成环，且每圈支撑体支架在周向延伸的同时，沿轴向起伏成波浪状；相邻两圈支撑体支架之间波峰对齐。
4.如权利要求3所述的主动脉裸支架，其特征在于，以相邻支撑体支架邻近波峰、波谷为连接点，所述连接体支架与相邻两圈支撑体支架上的相应连接点相连。
5.如权利要求4所述的主动脉裸支架，其特征在于，每圈连接体支架独立成环，且每圈连接体支架在周向延伸的同时，沿轴向起伏成波浪状，并与延伸路径两侧的每个连接点相连构成封闭网格结构。
6.如权利要求4所述的主动脉裸支架，其特征在于，每圈连接体支架独立成环，且每圈连接体支架在周向延伸的同时，沿轴向起伏成波浪状，连接体支架延伸路径两侧的部分波峰波谷作为连接点与连接体支架相连构成开环的网格结构。
7.如权利要求4所述的主动脉裸支架，其特征在于，所述连接体支架与对应的连接点采用缠绕或打结的方式相连。
8.如权利要求1所述的主动脉裸支架，其特征在于，多股复合丝由2-8股丝捻绕或者编织构成。
9.如权利要求1所述的主动脉裸支架，其特征在于，制作支撑体支架的超弹性镍钛丝的直径为0.2～0.45mm。
10.如权利要求1所述的主动脉裸支架，其特征在于，多股复合丝中每股丝的直径为0.05～0.2mm。
11.如权利要求1所述的主动脉裸支架，其特征在于，还包括至少一条轴向连接体，每条轴向连接体通过打结或缠绕的方式与支撑体支架上对应的连接点相连。
12.如权利要求11所述的主动脉裸支架，其特征在于，每条轴向连接体与相接触的所有或者部分支撑体支架相连。
13.如权利要求11或12所述的主动脉裸支架，其特征在于，多条轴向连接体沿主动脉裸支架的周向均匀分布。
14.一种主动脉夹层支架，包括相互对接的覆膜支架和裸支架，其特征在于，所述裸支架为权利要求1～13任一所述的主动脉裸支架。
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