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CN108670510B - 一种柔顺性优异的颅内血管支架 - Google Patents

一种柔顺性优异的颅内血管支架 Download PDF

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CN108670510B
CN108670510B CN201810492665.7A CN201810492665A CN108670510B CN 108670510 B CN108670510 B CN 108670510B CN 201810492665 A CN201810492665 A CN 201810492665A CN 108670510 B CN108670510 B CN 108670510B
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support ring
vascular stent
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CN108670510A (zh
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刘磊
丁红燕
姜海林
蒋欣
刘爱辉
张�成
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Huaiyin Institute of Technology
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    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

本发明公开了一种柔顺性优异的颅内血管支架，属于医疗器械技术领域，包括纵向设置的若干组支撑环单元，相邻的支撑环单元之间通过连接筋相连；每个支撑环单元包括若干个支撑环，每个支撑环均为Ω形，该Ω形支撑环首尾顺次相接。本发明的一种柔顺性优异的颅内血管支架，采用铰链连接的方式，支撑环与连接筋可以灵活的自由转动，保留了扩张式血管支架的优点的同时，极大的提高了支架的柔顺性能，解决了目前扩张式颅内血管支架产品柔顺性不足的问题。

Description

一种柔顺性优异的颅内血管支架
技术领域
本发明属于医疗器械技术领域，具体涉及一种柔顺性优异的颅内血管支架。
背景技术
颅内血管常位于蛛网膜下腔内为脑脊液所环绕，血管脆性大，支架输送和放置时易于发生破裂；同时，颅内血管存在多个生理弯曲，在弯曲段置放支架，血管拉直效应、支架贴壁不良发生的可能性更大，易诱发血栓栓塞事件和支架内再狭窄。颅内血管的生理特点，要求支架具有极高的柔顺性。
曾有学者用冠状动脉药物洗脱支架治疗颅内动脉狭窄，但颅内椎基底动脉血管迂曲，管壁薄、弹性差，其柔顺性比裸支架要差。支架系统通过性差，会损伤血管内膜，并导致并发症。为了满足病患的需求，颅内支架应运而生，主要用于治疗颅内动脉粥样硬化或者颅内动脉瘤。如同冠脉支架，根据展开形式的不同，颅内支架也有球囊扩张式和自膨式两种。
从临床角度考虑，球扩式支架较硬，通过性略差，对于迂曲严重的脑血管并不适用；但如果能顺利到达病变部位，效果立竿见影。自膨胀支架柔软、通过性好，但支架植入前需要使用球囊对病变部位预扩张，球囊和支架需要同轴交换使得操作更为复杂，同时自膨支架存在残余狭窄更高的缺点。
球囊扩张式颅内血管支架，采用的是“支撑环+连接筋”结构。支架是通过激光镂空切割薄壁圆管而成，支撑环和连接筋是一体的；在植入弯曲血管后，通过连接筋的塑形变形，适应血管的弯曲形态。其柔顺性的提高，始终是产品开发与应用中的瓶颈。
因此，设计新型的颅内血管支架结构，保留球囊扩张式支架优点的同时提高其柔顺性，是一项迫切且意义重大的工作。
发明内容
发明目的：本发明的目的在于提供一种柔顺性优异的颅内血管支架，支架具有优异的柔顺性，以及良好的压握性、支撑性、疲劳寿命、生物相容性等生物力学性能。
技术方案：为实现上述目的，本发明采用如下技术方案：
一种柔顺性优异的颅内血管支架，包括纵向设置的若干组支撑环单元，相邻的支撑环单元之间通过连接筋相连；每个支撑环单元包括若干个支撑环，每个支撑环均为Ω形，该Ω形支撑环首尾顺次相接；每个所述的支撑环的顶部和相邻支撑环的连接处均为支撑环单元圆角处，在支撑环单元圆角处上均设有通孔；所述的连接筋的两侧插入通孔后，经变形与通孔锁合，形成转动副连接。
装配之前，所述的连接筋包括一个连接主体和两个连接端部，连接主体为S形；装配时，连接筋和支撑环置于-10～10℃环境，连接端部发生马氏体相变，两个连接端部插入通孔中；装配后，在常温环境，连接端部由马氏体相变为奥氏体相，激励两个连接端部变形成锁扣形成锁合。
所述的通孔直径为0.04mm～0.06mm；连接筋直径与支撑环单元体上通孔直径的基准尺寸相等，配合方式为间隙配合。
所述的支撑环单元，经由薄壁圆管激光镂空切割而成，所述的连接筋由形状记忆合金定型处理制成。
所述的支撑环单元的轴向长度为0.5-2mm；连接筋的长度为0.5-1mm；连接筋的筋宽为60-200μm，支撑环的筋宽为60-160μm。
该柔顺性优异的颅内血管支架横向长度为8mm～40mm，其外径为1.60～2.00mm、壁厚为0.06mm～0.12mm。
每个支撑环单元包括的支撑环个数为6～16个。
发明原理：采用“支撑环+连接筋”结构作为支架主体结构，但其结构与已有的“支撑环+连接筋”结构的支架有着显著的不同：传统的“支撑环+连接筋”结构支架，通过激光镂空加工薄壁圆管而成，支撑环和连接筋是一体的，在植入弯曲血管后，通过连接筋的塑形变形，适应血管的弯曲形态。本发明的颅内血管支架由n组支撑环1和n-1组连接筋组成，其中支撑环与连接筋并非一体成型，而是相互独立的。支撑环端部带有通孔，连接筋通过自身的几何结构与两侧支撑环上的通孔形成转动副连接。
有益效果：与现有技术相比，本发明的一种柔顺性优异的颅内血管支架，采用铰链连接的方式，支撑环与连接筋可以灵活的自由转动，保留了扩张式血管支架的优点的同时，极大的提高了支架的柔顺性能，解决了目前扩张式颅内血管支架产品柔顺性不足的问题。
附图说明
图1为颅内血管支架剖切展开示意图；
图2为支撑环单元与连接筋单元的配合示意图；
图3为连接筋锁合之前的结构图；
图4为连接筋的俯视图；
图5为连接筋的正视图；
图6为连接筋的轴测图。
具体实施方式
为了进一步说明本发明，以下结合实施例对本发明进行详细描述。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。
如图1-6所示，附图标记如下：支撑环单元1、连接筋2、通孔11、支撑环单元圆角处12、连接端部21、连接主体22和锁扣23。其中，支撑环单元1的轴向长度为A，其范围为0.5-2mm；连接筋2的长度为B，其范围为0.5-1mm；连接筋2的筋宽为C，其范围为60-200μm，支撑环的筋宽为D，其范围为60-160μm。
根据具体临床应用的不同规格，颅内血管支架横向长度为8mm～40mm，其外径(横向为轴线方向将图1卷曲成圆柱体后的外圈直径)为1.60～2.00mm、壁厚(支撑环的厚度)为0.06mm～0.12mm。
一种柔顺性优异的颅内血管支架，包括纵向设置的若干组支撑环单元1，相邻的支撑环单元1之间通过连接筋2相连。纵向上，连接筋2间隔设置。
每个支撑环单元1包括若干支撑环，每个支撑环均为Ω形，该Ω形支撑环首尾顺次相接，相邻的支撑环以波峰和波谷相对的形式组合；每个支撑环的顶部和相邻支撑环的连接处均为支撑环单元圆角处12，在支撑环单元圆角处12上均设有通孔11。其中，每个支撑环单元1包括的支撑环个数为6～16个。
支撑环单元1，经由薄壁圆管激光镂空切割而成，连接筋2由形状记忆合金定型处理制成。连接筋2的两侧插入通孔11后，经变形与通孔11锁合，形成转动副连接。通孔11直径为0.04mm～0.06mm；连接筋2直径与支撑环单元体上通孔11直径的基准尺寸相等，配合方式为间隙配合。
连接筋2在装配之前，其结构如图3所示，其包括一个连接主体22和两个连接端部21，连接主体22为S形；装配时，将两个连接端部21插入通孔11中；装配后，通过温度改变，激励两个连接端部21变形，两个连接端部21变形成锁扣23的结构，形成锁合，锁合后的结构，如图4-6所示。相邻的两组连接筋2采用交错布置的形式。
连接端部21利用形状记忆合金在温度的激励下，通过奥氏体和马氏体相变完成形状的变化。通过热定型处理，连接端部21在马氏体相时为图3的结构，在奥氏体相下连接端部21为图4-6的锁扣23。因此，在装配时，将连接筋2和支撑环置于低温环境(-10℃-10℃)，连接端部21发生马氏体相变，为图3状态；在常温环境中(20℃-40℃)，连接端部21由马氏体相变为奥氏体相，连接端部21变成图4-6的锁扣23，完成锁合。

Claims (6)

1.一种柔顺性优异的颅内血管支架，其特征在于：包括纵向设置的若干组支撑环单元(1)，相邻的支撑环单元(1)之间通过连接筋(2)相连；每个支撑环单元(1)包括若干个支撑环，每个支撑环均为Ω形，该Ω形支撑环首尾顺次相接；每个所述的支撑环的顶部和相邻支撑环的连接处均为支撑环单元圆角处(12)，在支撑环单元圆角处(12)上均设有通孔(11)；所述的连接筋(2)的两侧插入通孔(11)后，经变形与通孔(11)锁合，形成转动副连接；装配之前，所述的连接筋(2)包括一个连接主体(22)和两个连接端部(21)，连接主体(22)为S形；装配时，连接筋(2)和支撑环置于-10～10℃环境，连接端部(21)发生马氏体相变，两个连接端部(21)插入通孔(11)中；装配后，在常温环境，连接端部(21)由马氏体相变为奥氏体相，激励两个连接端部(21)变形成锁扣(23)形成锁合。
2.根据权利要求1所述的一种柔顺性优异的颅内血管支架，其特征在于：所述的支撑环单元(1)，经由薄壁圆管激光镂空切割而成，所述的连接筋(2)由形状记忆合金定型处理制成。
3.根据权利要求1所述的一种柔顺性优异的颅内血管支架，其特征在于：所述的通孔(11)直径为0.04mm～0.06mm；连接筋(2)直径与支撑环单元体上通孔(11)直径的基准尺寸相等，配合方式为间隙配合。
4.根据权利要求1所述的一种柔顺性优异的颅内血管支架，其特征在于：所述的支撑环单元(1)的轴向长度为0.5-2mm；连接筋(2)的长度为0.5-1mm；连接筋(2)的筋宽为60-200μm，支撑环的筋宽为60-160μm。
5.根据权利要求1所述的一种柔顺性优异的颅内血管支架，其特征在于：该柔顺性优异的颅内血管支架横向长度为8mm～40mm，其外径为1.60～2.00mm、壁厚为0.06mm～0.12mm。
6.根据权利要求1所述的一种柔顺性优异的颅内血管支架，其特征在于：每个支撑环单元(1)包括的支撑环个数为6～16个。
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