CN1310599A - 可膨胀的固定模及其使用方法 - Google Patents

可膨胀的固定模及其使用方法 Download PDF

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CN1310599A
CN1310599A CN99808897A CN99808897A CN1310599A CN 1310599 A CN1310599 A CN 1310599A CN 99808897 A CN99808897 A CN 99808897A CN 99808897 A CN99808897 A CN 99808897A CN 1310599 A CN1310599 A CN 1310599A
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丹尼尔·L·考克斯
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Cardiovascular Systems Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/90—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
    • A61F2/91—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/90—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
    • A61F2/91—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/90—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
    • A61F2/91—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91516—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other the meander having a change in frequency along the band
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/90—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
    • A61F2/91—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/90—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
    • A61F2/91—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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Abstract

一种可膨胀的斯滕特固定模(stent),其结构为一系列环形排列的蛇形元件排布成相邻蛇形元件所确定的顶点相互嵌套,并且只有沿着每个蛇形元件的同一边延伸的顶点是相连的。这种结构增大了该固定模对被固定物的覆盖率、膨胀比和径向强度。

Description

可膨胀的固定模及其使用方法
发明背景
本发明一般涉及血管内固定模，更具体地涉及具有更大的覆盖率和膨胀比而且强度不会降低的改进型的血管内固定模。
把固定模或可膨胀的移植物植入各种体内遗腔中以力图维持它们的功能。这些器件典型的是通过使用一个导管插在易达到的部位并能向前深入到展开位点而植入腔内。该固定模最初处于径向压缩或收缩的状态使得操作时它能够通过腔内。固定模一旦就位就把它展开，根据其构造的不同，可以自动展开，或者通过带在导管上的气球的充气而手动展开。
由于固定模通常使用来把一个本来堵塞的、收缩的或者阻塞的腔撑开，处于膨胀状态的固定模必须具有足够的径向或环向强度才能有效地抵消预应力。把这样的应力尽可能多地分布在固定模上以及把这样的应力尽可能多地分在腔壁上均有助于把对腔壁的损伤减到最小。通过把固定模撑条间的距离缩减到最小，还可以预防进入腔中的撑条间的板脱垂。因此，希望通过在固定模撑条间产生均匀的小间隔来最大可能地增大对腔壁的覆盖率，而同时有必要使得固定模在收缩状态时尽可能小而紧凑，以利于其在腔内前进。因此，最希望的是其膨胀比尽可能地大。
为了达到这些众多的要求，迄今为止已经设计了许多不同的方法。一种流行的方法要求固定模整个由线构成。该线是弯曲的、编织的和/或绕成线圈状的，形成一个能承受径向扩张的一般为圆筒形的结构。使用线有许多缺点，例如截面积基本上恒定，这使得在固定模上某些部位集中的材料数量比理想数量多或者少。另外，线的形状也有局限，从而限制了使用它最终能够达到的膨胀比、覆盖率和强度。虽然以前还使用把线的相邻部分焊接在一起来增大强度的办法，但随之生产费用也大为提高。
另一种线基结构是用管材做成。通过选择性地从这种管材中移去材料，可以使这种结构的柔韧性和扩张度达到所需的程度。化学刻蚀技术和激光刻蚀方法均被用来从管材中除去材料。激光刻蚀的精度和准确性高，用它可以从管材中按确定的图案除去材料，留下高度精致和准确的图案。这种固定模的性能参数是与移去材料后形成的图案非常相关的函数。特定图案的选择对所得的固定模的覆盖率、膨胀比和强度具有很大的影响。
与线基固定模相比管基固定模虽具有很多优点，但还需要努力改进管基固定模的设计以便在保持强度的同时进一步提高覆盖率和膨胀比。
发明概述
本发明提供一种改进的具有高覆盖率、膨胀比和强度的管基固定模。其改进在于选择管材中要切割或刻蚀的精致图案。留下的构成固定模的材料结构包括一系列嵌套的蛇形元件，其中选定的顶点相互之间通过连接元件连接。更具体地，每个蛇形元件沿着固定模以圆周形方式延伸，使得每个元件的逐个顶点沿着固定模表面交替地向远端和邻位延伸。相邻的蛇形元件沿着固定模间隔排列，其中每个元件的顶点嵌套在相邻的元件中，使得一个元件的顶点延伸到介于相邻元件顶点之间的空间中。蛇形元件沿着它们所有的远端或近端顶点相互连接。沿着交接边延伸的特定元件的每个顶点通过桥接元件交替地与相应的近端或远端邻接的蛇形元件连接。通过把介于每个桥接元件和顶点之间的连接面制成合适的形状，减小或消除了应力增长源，相应地降低了膨胀过程中发生断裂的可能性。通过使每个给定元件的顶点之间延伸的横向部分弯曲，相邻元件变得更加紧凑了，从而能达到20％以上的覆盖率和3.0的膨胀比，也能达到6.0以上的膨胀比。更为重要的是，这种覆盖密度在整个固定模中都是均匀分布的。
以下结合附图对优选实施方式的详细描述以及根据实例对本发明的原理所作的说明，使本发明的这些及其它特征和优点将变得很明显。
附图的简单描述
图1是处于收缩状态的本发明的固定模截面压平的平面图。
图2是处于收缩状态的另一种实施方式的固定模截面压平的平面图。
图3是处于收缩状态的另外一种实施方式的固定模截面压平的平面图。
图4是处于收缩状态的另一种实施方式的固定模截面压平的平面图。
图5是图4中所示的固定模处于部分膨胀状态时的视图。
图6是图5中所示的固定模处于进一步膨胀状态时的视图。
图7是处于收缩状态的本发明的另一种实施方式的固定模截面压平的平面图。
优选实施方式的详细描述
本发明的目的是一种用具有一定构型的由管材生产的固定模，这种构型能使其具有比现有固定模更大的覆盖率和膨胀比，而且不会使强度降低。为了更清楚，每个附图示出了这种固定模部分的压平的平面图。本发明的固定模一般是利用化学刻蚀方法或者激光刻蚀方法从管状元件制成的。US5,421,955(Lau等人)中公开了一种典型的化学刻蚀方法，该专利由Advanced Cardiovascular Systems,Inc.转让和持有，在此作为本发明参考文献。本发明的固定模优选的是按照Advanced Cardiovascular Systems,Inc.的美国专利申请号08/783,698(在此通过参考文献引入)中公开的激光刻蚀方法制成的。
图1表示了本发明的一般概念。示出的是由蛇形元件14组成的组件12，其中相邻元件的顶点之间相互嵌套。在其三维结构中，每个蛇形元件在固定模方向上沿圆周方向延伸，使得例如端点20与端点22接触。以这种方式组合的元件的总数决定了固定模的总的长度。每个平行的蛇形元件通过从位于蛇形元件一边的顶点伸出的桥接元件18与相邻的元件相连。这样的顶点依次与邻接和远接的蛇形元件的相应顶点连接。
图2表示另一种方式的嵌套设计24，其中通过改变桥接元件26而进一步改善了覆盖面积。把每个桥接元件加宽而使表面积达到同等程度的增大。在桥接元件和蛇形元件的连接部分之间保留了足够的空隙以防备在膨胀过程中发生接触和干扰。
图3表示了另一种实施方式32，其中在固定模膨胀过程中在桥接元件36和顶点40的凹边38的连接点34附近产生的应力比图1和2中所示的实施方式减小了。图1和2中示意的构型随着在这样的连接点处物质浓度的增大而形成锐角。因此，在膨胀过程中材料的弯曲将把材料集中于锐角附近，而在顶点中心处的材料减少很多，从而促进了断裂和发生断裂的可能性。通过消除锐角和顶点处物质的集中而形成一种“w”形状，更加均匀地把膨胀过程中产生的应力沿着顶点分散了。
图4表示了另一种实施方式42，其中包含了图3的实施方式的优点和用于增大固定模覆盖面和膨胀比的其它特征。从图中可以看出，每个连接相邻顶点46,48的蛇形元件的横向部分44在50处弯曲以适应相邻的蛇形元件的顶点，从而使包装更紧凑。将横向部分弯曲成足以使其在绕邻近顶点处弯曲之前尽可能地在52处与桥接元件52接近。将交替部分弯曲成足以使其在54处基本上隔开了。该构型大大提高了覆盖面和膨胀比，同时使固定模能承受无限制的膨胀。图5举例说明了部分膨胀的这种固定模构型，它表明了将所有元件相互之间移开时不存在干扰。图6示意了实质上处于更大膨胀状态的固定模。图6的构造达到了高达6.7的理论膨胀比。
图7示意了本发明的最优选的实施方式，该实施方式包含了其它图中所示实施方式的许多特征，包括平行的蛇形元件的嵌套构造、连接相邻的蛇形元件顶点的桥接单元、降低应力的“W”型顶点和弯曲的连接片段。加宽的蛇形元件和桥接单元以及更紧凑的半径产生了具有异常高覆盖面和膨胀比以及相当强度的固定模。
本发明的固定模优选利用本领域熟知的激光刻蚀技术生产。这种固定模的生产中所用的材料可以是含延展性低的材料(例如可膨胀型气球所用的钛)的经过充分加工的不锈钢。另外，NiTi可用于自膨胀的实施方式中。
虽然已举例说明了本发明固定模的具体形式，然而很显然，本领域技术人员可以在不偏离本发明构思和范围的情况下进行各种修饰。本发明也不限于针对任何特定体腔的固定模。固定模内径、外径、壁厚和长度的大小均可以变化。因此，本发明并不是仅限于所附的权利要求书。

Claims (9)

1．一种固定模，包括：
一系列环形放置的蛇形元件，每个这样的元件包括一系列向邻近边延伸的顶点和一系列向远端边延伸的顶点，其中相邻的蛇形元件的顶点之间相互嵌套，而且其中相邻的蛇形元件通过在位于每个元件同一边的顶点之间进行延伸的桥接单元连接。
2．权利要求1的固定模，其中从蛇形元件伸出的桥接单元交替地在远端和近端邻接的蛇形元件的顶点之间延伸。
3．权利要求2的固定模，其中桥接单元在向远端边延伸的顶点之间延伸。
4．权利要求3的固定模，其中与近端邻接的蛇形元件的向远端延伸的顶点相连的每个向远端延伸的顶点是“W”形。
5．权利要求2的固定模，其中桥接单元在向近端边延伸的顶点之间延伸。
6．权利要求5的固定模，其中与远端邻接的蛇形元件的向近端延伸的顶点相连的每个向近端延伸的顶点是“W”形。
7．权利要求2的固定模，还包括在蛇形元件的顶点之间延伸的横向部分，该横向部分是足够弯曲的使得从同一个顶点延伸的横向部分基本上相互接触。
8．权利要求2的固定模，还包括在蛇形元件的顶点之间延伸的横向部分，该横向部分是足够弯曲的使得它实质上与在其间延伸的桥接单元接触。
9．权利要求1的固定模，其中固定模用取自由不锈钢、钛、钽和镍-钛组成的这组金属合金制成。
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WO1999065421A3 (en) 2000-01-27
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