CN1736349A - 组合式可任意方向弯曲的覆膜支架 - Google Patents

组合式可任意方向弯曲的覆膜支架 Download PDF

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CN1736349A
CN1736349A CNA2004100538167A CN200410053816A CN1736349A CN 1736349 A CN1736349 A CN 1736349A CN A2004100538167 A CNA2004100538167 A CN A2004100538167A CN 200410053816 A CN200410053816 A CN 200410053816A CN 1736349 A CN1736349 A CN 1736349A
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罗七一
许尚栋
聂红林
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Shanghai Microport Endovascular Medtech Co Ltd
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Microport Medical Shanghai Co Ltd
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    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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Abstract

本发明设计了一种用于对人体病变血管进行腔内隔绝治疗的组合式可任意方向弯曲的覆膜支架，包括多个中间覆膜支架单元和一个尾端覆膜支架单元，每个覆膜支架单元包括支架单元和管状的覆膜单元，支架单元通过缝合线缝合固定在覆膜单元上；支架单元为采用合金丝加工的包括多个波形单元的封闭的圆柱状结构；覆膜支架单元之间通过缝合线缝合，相邻的覆膜支架单元均有部分重叠。本发明具有结构稳定、可向任意方向弯曲、弯曲时内壁光滑等优点，克服了现有同类产品存在方向性的缺陷。可以用于人体动脉、静脉或者其它管腔内病变的治疗，特别是用于大动脉血管病变的治疗。

Description

组合式可任意方向弯曲的覆膜支架
技术领域
本发明涉及一种治疗动脉瘤的微创伤介入医疗器械产品，具体地说，涉及一种可以向任意方向弯曲的覆膜支架。
背景技术
动脉瘤是临床上十分凶险的一种血管疾病，多发生在55岁左右的老年人，近年来开始逐渐向中、青年人群发展。据相关统计资料表明：动脉瘤患者如果不及时采取的治疗措施，在24小时内的死亡率达15％左右，一周以内的死亡率达30％左右，一个月内的死亡率达75％左右，而5年的生存率仅为17％。因此，一经发现动脉瘤患者，应尽快对其进行相应治疗。
目前，利用腔内隔绝原理的微创伤介入治疗技术得到广泛的利用，它是用一套管径较细的输送系统，将被压缩状态的覆膜支架送达病变血管的位置后准确释放，覆盖在病变血管段，隔绝瘤腔并形成新的血流通道；动脉瘤在丧失血液供应后，瘤腔内残留血液逐渐形成血栓并肌化成血管组织，扩张状态的瘤壁因受负压而收缩，逐渐恢复到接近原始形态，从而达到治疗动脉瘤的目的。
目前市场上已经出现多种结构的覆膜支架及输送系统。但多数覆膜支架的设计均存在一根连接杆，它从覆膜支架一端到另一端，贯穿整个覆膜支架，起保持覆膜支架的长度与连接各段支架的作用。这样的设计使覆膜支架的弯曲具有一定的方向性，即在连接杆所在的方向，覆膜支架不能弯曲；如果强制性弯曲，将导致覆膜支架整体打折，变形，使覆膜支架的贴壁性能变差，在血管内的受力状态也相应恶化，因此，会导致覆膜支架容易移位，对手术治疗效果及患者的健康与生命安全构成极大威胁。因此，具有方向性的覆膜支架在使用时，必须采取足够的措施(包括设计、加工过程以及使用过程)，保证在将其通过输送系统送入人体内时，其方向是正确的。这一方面增加了产品的设计与加工难度，增加了产品使用风险，同时也增加了产品操作的难度。
发明内容
本发明所要解决的技术问题是提供一种结构稳定、可向任意方向弯曲的、弯曲时内壁光滑的、适合于治疗血管动脉瘤病变的覆膜支架，以克服现有产品存在的方向性缺陷。
本发明解决技术问题的技术方案如下：
本发明组合式可任意方向弯曲的覆膜支架，形状为管状结构，包括多个中间覆膜支架单元和一个尾端覆膜支架单元，每个覆膜支架单元包括支架单元和管状的覆膜单元，所述支架单元通过缝合线缝合固定在覆膜单元上；所述支架单元为采用合金丝加工的包括多个波形单元的封闭的圆柱状结构；所述覆膜支架单元之间通过缝合线缝合，相邻的覆膜支架单元均有部分重叠。
其中近端指的是覆膜支架靠近心脏的一端，远端即是覆膜支架远离心脏的一端。
其中每个覆膜支架单元的支架单元可以缝合在管状覆膜单元的内表面，也可以缝合在管状覆膜单元的外表面。
中间覆膜支架单元的覆膜单元的轴向长度比尾端覆膜支架单元的覆膜单元长；中间覆膜支架单元的覆膜单元的轴向长度为14～60mm，尾端覆膜支架单元的覆膜单元的轴向长度为10～40mm；所述支架单元的波形的个数为4～10个，波峰与波谷的高度差的范围为10～40mm。
合金丝的材料选自镍钛形状记忆合金、镍钛超弹性合金、316L医用不锈钢合金、可植入的钴铬镍钼铁合金中的一种，合金丝的直径范围为0.254～0.635mm；所述管状覆膜单元的材料选自聚四氟乙烯、聚酯纤维纺织物、聚酰胺纺织物、聚丙烯纺织物中的一种；所述缝合线的材料选自聚丙烯、聚酯、聚酰胺、真丝、聚四氟乙烯、氟乙烯中的一种。
所述支架单元由合金丝经过冷变形加工，或者热处理加工，或者冷变形加工结合热处理加工定型为多个等高波形结构，然后通过自身焊接方式将两端连接，或者通过合金管套接后焊接方式连接，或者通过合金管套接后机械方式连接而成一个封闭的柱状单元；合金管的材料可以是316L医用不锈钢合金、或可植入的钴铬镍钼铁合金。
本发明与现有血管支架相比的有益效果是：
由于覆膜支架采用覆膜单元作为支架单元的中间连接体，没有连接杆结构，覆膜支架也就没有方向性，因此在设计、加工及使用中，均不需要关注覆膜支架的方向性，减少了生产与质量控制成本，简化了使用中的操作难度，消除了覆膜支架的方向性导致的各种产品风险；同时，本发明所述的覆膜支架在弯曲状态下，覆膜支架的内壁更加光滑，从而改善覆膜支架在血管内的流体动力学状态，减少血液对覆膜支架的冲击阻力，进而减少覆膜支架移位的可能性，并减少覆膜支架内形成的血栓。
附图说明
图1为本发明的覆膜支架的结构示意图；
图2为本发明的覆膜支架另一种实施例示意图；
图3为中间覆膜支架单元结构示意图；
图4为相邻覆膜支架单元连接结构示意图；
图5为支架单元的展开结构示意图；
图6为本发明弯曲时的实际效果示意图。
具体实施方式
下面结合附图进一步说明本发明。
参见图1，图2、图5和图6，本发明所述的组合式可任意方向弯曲的覆膜支架形状为管状结构，包括多个中间覆膜支架单元2和一个尾端覆膜支架单元3，每个覆膜支架单元包括支架单元4和管状的覆膜单元5，所述支架单元4通过缝合线6缝合固定在覆膜单元5上；所述支架单元3为采用合金丝加工的包括多个波形单元的封闭的圆柱状结构；所述覆膜支架单元之间通过缝合线6缝合，相邻的覆膜支架单元均有部分重叠。参见图2本发明覆膜支架还可以有选择的包括一个近端裸段1和一个远端裸段7，近端裸段1通过缝合线6与覆膜支架上最近端的中间覆膜支架单元2缝合固定，远端裸段7通过缝合线6与尾端覆膜支架单元3缝合固定。
参见图3，中间覆膜支架单元2和尾端覆膜支架单元3分别由支架单元4与管状覆膜单元5经缝合线6缝合而成；中间覆膜支架单元2和尾端覆膜支架单元3的区别在于，中间覆膜支架单元2所用的管状覆膜单元的轴向长度比尾端覆膜支架单元3所用的管状覆膜单元长；
在将支架单元4与管状覆膜单元5缝合成为覆膜支架单元2，3时，可以将支架单元4缝合在管状覆膜单元5的内表面，也可以缝合在外表面；
尾端覆膜支架单元3所用的管状覆膜单元的长度为10～40mm，中间覆膜支架单元2所用的管状覆膜单元的长度为14～60mm；中间覆膜支架单元的覆膜单元轴向长度的优选长度为25～40mm，尾端覆膜支架单元的覆膜单元轴向长度的优选长度为20～35mm；
参见图4，在将中间覆膜支架单元与中间覆膜支架单元缝合，或者将中间覆膜支架单元2和尾端覆膜支架单元3缝合时，将位于近端的中间覆膜支架单元套在位于远端的中间覆膜支架单元或者尾端覆膜支架单元2内，并使二个覆膜支架单元部分重叠，然后用缝合线将近端的中间覆膜支架单元2的下沿与远端的覆膜支架单元2，3缝合在一起；缝合时，所有近端的覆膜支架单元2的支架单元4的波谷，均位于远端的覆膜支架单元2、3的支架单元4的二个相邻波峰的近似中间位置；
在缝合近端裸段1时，使近端裸段1的远端与最近端的覆膜支架单元2的近端部分重叠，并且近端裸段1的波谷均位于最近端的覆膜支架单元2的支架单元4的二个相邻波峰的近似中间位置；
在缝合远端裸段7时，使远端裸段7的近端与尾端覆膜支架单元3的远端部分重叠，并且远端裸段7的波峰位于尾端覆膜支架单元3的支架单元4的二个相邻波谷的近似中间位置；
参见图1，支架单元4由合金丝经过冷变形加工，或者热处理加工，或者冷变形加工结合热处理加工定型，然后通过自身焊接方式连接，或者通过合金管8套接后焊接方式连接，或者通过合金管8套接后机械方式连接而成一个柱状单元；
经过加工的合金丝的波形的个数可以为4～10个，优选的波形个数为5～6个，每个波形单元的波峰与波谷的高度差的范围为10～40mm，优选的波峰与波谷的高度差范围为20～35mm；
按照本发明，覆膜支架的长度(不包含近端裸段1和远端裸段7)可以根据需要变化，这主要通过改变缝合的中间覆膜支架单元2的数量来实现；
参见图1、图2，本发明覆膜支架的最近端管状覆膜的直径与最远端的管状覆膜的直径可以相同，也可以不同；
材料应用
所述的合金丝应采用具有良好的生物相容性、化学稳定性和机械物理性能的材料，以满足植入人体的要求，包括：镍钛形状记忆合金、镍钛超弹性合金、316L医用不锈钢合金、可植入的钴铬镍钼铁合金。合金丝1的直径范围为0.010”～0.025”(0.254～0.635mm)。
所述的管状覆膜单元2、3的材料包括：聚四氟乙烯(Polytetrafluoroethylene，expanded Polytetrafluoroethylene)、聚酯纤维纺织物(Polyester)、聚酰胺纺织物(Polyamide)、聚丙烯纺织物(Polypropylene)。
所述的缝线6采用的材料包括：聚丙烯、聚酯、聚酰胺、真丝、聚四氟乙烯、氟乙烯中的一种。
所述的合金管8可采用的材料包括：316L医用不锈钢合金、可植入的钴铬镍钼铁合金的一种。

Claims (10)

1.一种组合式可任意方向弯曲的覆膜支架，形状为管状结构，其特征在于，包括多个中间覆膜支架单元(2)和一个尾端覆膜支架单元(3)，每个覆膜支架单元包括支架单元(4)和管状的覆膜单元(5)，所述支架单元(4)通过缝合线(6)缝合固定在覆膜单元(5)上；所述支架单元(4)为采用合金丝加工的包括多个波形单元的封闭的圆柱状结构；所述覆膜支架单元之间通过缝合线(6)缝合，相邻的覆膜支架单元均有部分重叠。
2.根据权利要求1所述的组合式可任意方向弯曲的覆膜支架，其特征在于，中间覆膜支架单元的覆膜单元的轴向长度比尾端覆膜支架单元的覆膜单元长；中间覆膜支架单元的覆膜单元的轴向长度为14～60mm，尾端覆膜支架单元的覆膜单元的轴向长度为10～40mm；
3.根据权利要求1所述的组合式可任意方向弯曲的覆膜支架，其特征在于，所述支架单元的波形的个数为4～10个，波峰与波谷的高度差的范围为10～40mm。
4.根据权利要求1所述的组合式可任意方向弯曲的覆膜支架，其特征在于，支架单元(4)缝合在管状覆膜单元(5)的内表面上。
5.根据权利要求1所述的组合式可任意方向弯曲的覆膜支架，其特征在于，两相邻覆膜支架单元，近端覆膜支架单元位于远端覆膜支架单元之内，近端覆膜支架单元的支架单元的波谷位于远端覆膜支架单元的支架单元的两个相邻波峰的近似中间位置。
6.根据权利要求1至5任一项所述的组合式可任意方向弯曲的覆膜支架，其特征在于，所述覆膜支架近端通过缝合线连接有近端裸段(1)，所述近端裸段(1)与支架单元(4)结构相同，所述近端裸段的远端与相邻覆膜支架单元的近端部分重叠，近端裸段的波峰均位于相邻覆膜支架单元的支架单元的二个相邻波谷的近似中间位置。
7.根据权利要求1至5任一项所述的组合式可任意方向弯曲的覆膜支架，其特征在于，所述覆膜支架远端通过缝合线连接有远端裸段(7)，所述远端裸段(7)与支架单元(4)结构相同，所述远端裸段的近端与相邻覆膜支架单元的远端部分重叠，远端裸段的波峰均位于相邻覆膜支架单元的支架单元的二个相邻波谷的近似中间位置。
8.根据权利要求6所述的组合式可任意方向弯曲的覆膜支架，其特征在于，所述覆膜支架远端通过缝合线连接有远端裸段(7)，所述远端裸段(7)与支架单元(4)结构相同，所述远端裸段的近端与相邻覆膜支架单元的远端部分重叠，远端裸段的波峰均位于相邻覆膜支架单元的支架单元的二个相邻波谷的近似中间位置。
9.根据权利要求6所述的组合式可任意方向弯曲的覆膜支架，其特征在于，所述支架单元的合金丝在结合处采用一根合金管(8)将两端连接成为一个封闭的圆柱状，所述合金管的材料选自316L医用不锈钢合金、或可植入的钴铬镍钼铁合金。
10.根据权利要求1至5任一项所述的组合式可任意方向弯曲的覆膜支架，其特征在于，所述合金丝的材料选自镍钛形状记忆合金、镍钛超弹性合金、316L医用不锈钢合金、可植入的钴铬镍钼铁合金中的一种，合金丝的直径范围为0.254～0.635mm；所述管状覆膜单元的材料选自聚四氟乙烯、聚酯纤维纺织物、聚酰胺纺织物、聚丙烯纺织物中的一种；所述缝合线的材料选自聚丙烯、聚酯、聚酰胺、真丝、聚四氟乙烯、氟乙烯中的一种。
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AT05757084T ATE476942T1 (de) 2004-08-17 2005-06-08 Kombinierter filmbeschichteter stent, der in jeder richtung biegbar ist
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