CN110785146A - 血管内支架 - Google Patents

血管内支架 Download PDF

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Publication number
CN110785146A
CN110785146A CN201780092205.9A CN201780092205A CN110785146A CN 110785146 A CN110785146 A CN 110785146A CN 201780092205 A CN201780092205 A CN 201780092205A CN 110785146 A CN110785146 A CN 110785146A
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stent
cylindrical ring
peaks
lever arms
cylindrical
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D·U·塔
E·D·伊莱
N·J·贝
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Abbott Cardiovascular Systems Inc
Abbott Vascular Inc
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Abbott Vascular Inc
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Abstract

本发明涉及一种用于植入体腔(诸如冠状动脉、外周动脉或其它体腔)的可扩展支架。本发明提供了血管内支架,该血管内支架具有通过波状连接件连接的多个筒状环。该支架在纵向上具有高度的柔性,但也具有充分的血管壁覆盖和足够的径向强度以保持动脉或其它体腔的开放。该支架能够以非常低的轮廓被压缩或压接于导管,这是因为一些峰和谷的曲率内半径使支架以非常低的轮廓压接于导管并相对于现有技术的支架增大了径向强度。

Description

血管内支架
背景技术
本发明涉及血管修复装置,特别是血管内支架,其适于植入患者的体腔(诸如血管或冠状动脉)以维持其开放。支架在治疗动脉和血管中的粥样硬化狭窄中特别有用。
支架通常是管状装置,其功能是保持一段血管或其它体腔(诸如冠状动脉)的开放。它们还适用于支撑和阻止能够阻塞流体通道的解剖动脉膜(dissected arteriallining)。目前,在世界范围内有许多商业支架销售。例如,图1A至图1C中绘示的现有技术支架具有由一个或多个波状连接件连接的多个筒状环。尽管这些支架中的一些是柔性的且具有保持血管或动脉开放所需的适当径向刚性,但是在柔性和径向强度与将支架紧密压缩或压接(crimp)于导管使得它在被受控植入血管之前不会相对于导管过早地移动或取出的能力之间通常存在权衡。
需要并且迄今为止无法获得的是这样的支架:该支架具有高度的柔性,以使其能够通过曲折的通道前进并且能够在治疗部位容易地扩展,并且还具有保持其所植入的体腔或动脉开放的机械强度并提供充分的血管壁覆盖。本发明满足该需求。也就是,本发明的支架具有用于将自身固定于导管的高度压缩性,并提供了使支架能够容易地通过曲折的动脉前进的低轮廓(profile)和高度柔性,并且该支架具有足够的径向刚性,使其能够保持动脉或其它血管开放或者巩固解剖膜并提供充分的血管壁覆盖。
发明内容
本发明涉及一种血管内支架,该血管内支架具有允许支架被紧密地压缩或压接于导管的图案或构造,以提供极低的轮廓并防止支架与导管之间的相对运动。支架沿其纵向轴线也是高柔性的,从而有助于输送通过曲折的体腔,但是支架在其扩展状态下在径向上足够的僵硬和稳定,从而在支架被植入时维持体腔(诸如动脉)的开放。换言之,本发明的支架能够以非常低的轮廓紧密地压接于球囊导管,并且沿其纵向轴线提供柔性,同时该支架在血管中扩展到植入直径时维持非常高的径向强度。
本发明的支架通常包括互连以形成支架的多个筒状环。如果支架为球囊可扩展型,则支架通常安装于球囊导管,或者如果支架是自扩展的,则安装到没有球囊的导管上或导管中。
构成支架的各筒状环具有近端和远端以及由筒状外壁面限定的筒状平面,该筒状外壁面在筒状环的近端与远端之间沿周向延伸。通常,筒状环具有蜿蜒或波状的形状,其包括至少一个U形元件,并且各环通常具有多于一个的U形元件。筒状环通过至少一个波状连接件互连,该波状连接件使一个筒状环附接于相邻的筒状环。波状连接件是高柔性的,并且允许支架沿其纵向轴线具有高柔性。至少一些波状连接件具有弯曲部分,该弯曲部分横向于支架的纵向轴线延伸与一个U形元件一致的预定距离。更具体地,弯曲部分以横向方式延伸,使得其将与对应的U形元件相交,然而,该对应的U形元件的长度比同一环中的其它U形元件的长度短。因此,当支架被压缩或压接于导管时,连接件的弯曲部分不会与相邻的U形元件重叠或相交,这是因为该元件的长度比特定环中类似的U形元件的长度短。以这种方式,支架能够以更紧密或更小的直径压缩或压接于导管,这允许低轮廓输送以及导管上的紧密夹持力,从而减小了在输送期间以及在血管中植入支架之前支架与导管之间的移动的可能性。
波状连接件可以采用各种构造,但通常具有波状的或蜿蜒的形状。波状连接件能够包括由直线部分连接的弯曲部,其中直线部分大致垂直于支架的纵向轴线。
不仅使筒状环互连的波状连接件对支架提供柔性,而且在支架在沿其纵向轴线的任意方向上弯曲时连接件的定位也通过允许一致的柔性来增强柔性。沿着支架的一致柔性部分地源自一个环的连接件在周向上与相邻环中的连接件错开。此外,筒状环被构造成对支架提供柔性,这是因为在支架被输送通过曲折的血管时,环的部分能够折曲或弯曲。
筒状环通常由多个峰和谷形成,其中一个筒状环的谷与相邻筒状环的谷在周向上排列。在这种构造中,至少一个波状连接件以如下方式使各筒状环附接于相邻的筒状环:波状连接件的至少一部分定位在一个谷内,并且波状连接件使谷附接于相邻的谷。
尽管筒状环和波状连接件通常不是分离结构,但是为了便于识别,它们通常被便利地称为环和连接件。此外,能够认为筒状环的远端侧以重复的图案包括一系列U形、W形和Y形结构,同时近端筒状环所包括的全是U形元件。同样,尽管筒状环未被划分或分段成U形、W形和Y形,但是筒状环的图案类似于这种构造。U形、W形和Y形主要通过在支架被输送通过曲折的血管时进行折曲来提升柔性。
波状连接件被定位成使连接件的弯曲部分在W形部分的弯曲部的外侧。由于在支架扩展时弯曲部分基本上不会扩展(如果有的话),所以即使在支架扩展时W形部分的弯曲部展开,该弯曲部分也将继续提供良好的血管壁覆盖。连接件的弯曲部分在横向于支架的纵向轴线的方向上延伸一定距离,该距离使弯曲部分定位成邻近和靠近U形元件的峰。这些U形元件的支柱(strut)比同一筒状环中的其它U形元件的支柱短,使得在支架被压缩时,即使连接件的弯曲部分和U形元件沿支架的纵向轴线排列,连接件的弯曲部分也不会与相邻的U形元件重叠。
在一个实施方式中,U形部分、Y形部分和W形部分中的一些或全部的内半径比现有技术的支架小,并且优选地在远端环不大于0.002677英寸(68微米)且在主体环和近端环不大于0.001969英寸(50微米)。减小的半径提供了一种支架,该支架能够以非常低的轮廓压接于球囊导管,并且在支架扩展到植入直径时提供增大的径向强度。
在另一实施方式中,波状连接件具有用于使波状连接件与相邻的筒状环连接的第一臂和第二臂。第一臂中的一些或全部沿着长度具有多个略弯曲部,以减小在压缩和扩展期间相邻的杆臂朝向连接件摇摆的可能性。结果是较直的压接的支架和较直的扩展的支架。使相邻的筒状环互连的波状连接件的数量和位置能够根据应用的需要而变化。由于在支架的筒状环径向向外扩展时波状连接件通常不扩展,所以连接件自由地继续提供柔性并且还提供支撑(scaffolding)功能以帮助血管或动脉保持开放。重要的是,波状连接件的添加或移除对于支架的整体纵向柔性的影响非常小。各波状连接件被构造为使波状连接件提升柔性,而一些现有技术的连接件实际上减小支架的柔性。
当超过屈服应力地扩展时,金属球囊可扩展支架的筒状环会塑性变形。通常,金属球囊可扩展支架由不锈钢合金、钴-铬合金、钛或类似材料制成。
类似地,当支架由超弹性合金(诸如镍-钛(NiTi)合金)形成时,支架的筒状环径向向外扩展。在超弹性合金的情况下,如同在伪弹性相变的情况下,支架在应用于温度变化或者当应力缓解时扩展。
由于连接件的波状构造,支架沿其轴线具有高度柔性,这减小了支架起鳞(fishscaling)(即,扩口(flaring))趋势。当将支架部署在弯曲的动脉或血管中时可能发生支架起鳞,并且支架的部分向外突出。本发明的波状连接件减小了起鳞的可能性。
此外,由于连接件的定位以及连接件在支架径向扩展时不会显著扩展或伸展的事实,在处于非扩展构造和扩展构造时,支架的总长度基本相同。换言之,支架在扩展时将基本上不会缩短。
通过在管中激光切割筒状环和波状连接件的图案可以由管形成支架。还可以通过以筒状环和连接件的图案激光切割平坦的金属片、然后将图案卷成管状支架的形状并提供纵向焊接来形成支架。
附图说明
图1A是本发明的一个实施方式的现有技术的平坦支架的平面图,其示出了环和连接件的图案。
图1B是被扩展到植入直径的图1A中的现有技术支架的局部平面图。
图1C是图1A中的现有技术支架的一部分的平面图,该现有技术支架被卷成筒状构造并紧密地压接,使得各种支架的支柱紧密接触或彼此接触。
图2A是扩展的管状支架的一个实施方式的平面图,其示出了筒状环和波状连接件的图案。
图2B是图2A中的管状支架的平面图,其示出了处于压接构造的筒状环和波状连接件的图案。
图2C是图2B中的管状支架的端视图,其绘示了支架的筒状平面。
图3是图2A中的扩展的管状支架的平坦构造的一部分的平面图。
图4是图3中的支架的一部分的平面图,其绘示了一些谷中的减小的内半径和一些杆臂中的增大的支柱宽度。
图5是图3中的支架的一部分的放大平面图。
图6是图2A中的支架的一部分的平面图,其绘示了杆臂的支柱宽度和远端环的峰。
图7是图2A中的支架的一部分的平面图,其绘示了杆臂的支柱宽度和主体环的峰。
图8是图2A中的支架的一部分的平面图,其绘示了杆臂的支柱宽度以及近端环和相邻的环或第二近端环的峰。
图9A是扩展的管状支架的一个实施方式的平面图,其示出了筒状环和波状连接件的图案。
图9B是图9A中的管状支架的平面图,其示出了在压接构造中筒状环和波状连接件的图案。
图10是图9A中的支架的一部分的平面图,其绘示了一些峰和谷中的减小的内半径和一些杆臂中的增大的支柱宽度。
图11是图9A中的支架的一部分的平面图,其绘示了杆臂的支柱宽度和远端环的峰。
图12是图9A中的支架的一部分的平面图,其绘示了杆臂的支柱宽度和主体环的峰。
图13是图9A中的支架的一部分的平面图,其绘示了杆臂的支柱宽度以及近端环和相邻的环或第二近端环的峰。
具体实施方式
本发明的支架通过提供具有独特设计图案和新颖互连构件的纵向柔性支架而改善了现有支架。除了提供纵向柔性之外,本发明的支架还提供了径向刚性和对血管壁(诸如冠状动脉)的高度支撑。高柔性的互连构件的设计以及它们相对于相邻的U形构件的布置提供了紧密压缩到导管上的支架,同时保持了在输送期间的高度柔性。
与现有技术支架相关联的问题之一是更紧密地压接(crimped)或压缩到导管的球囊部分的能力。优选地,连接件的波状部分与相邻的支柱不应重叠,因此连接件的波状部分限制了各筒状环在导管的球囊部分上的压接量或压缩量。本发明解决了该问题并允许支架紧密压缩或压接到导管上。
图1A至图1C绘示了各种构造的现有技术支架。参照图1A,以平坦状态示出支架,使得能够清楚地观察到图案,即使支架在使用时处于诸如图1C所示的筒状形式。支架典型地由管状构件形成,然而支架能够由诸如图1A所示的平坦片材形成并且能够被卷成如图1C所示的筒状构造。
根据本发明,并如图2A至图8所示,支架38由多个筒状环40构成,筒状环40在处于管状形式时绕着支架周向地延伸。支架具有如图2A所示的植入直径(implanted diameter)42和如图2B所示的输送直径(delivery diameter)44。输送直径44表示支架能够被压接到输送导管的球囊上的紧密程度,对于小直径支架,最小压接轮廓或直径能够小至0.0297英寸(0.754mm)。图2B中所示的支架通常将被更紧密地压接或压缩以进行血管中的输送,然而,在该视图中更容易观察和描述组成部件。各筒状环40具有近端46和远端48。筒状环40通过波状连接件50彼此连接。典型地,由于支架是从管上激光切割的,因此不存在诸如所说明的筒状环和连接件的分立部件,然而,如下地识别和参照各种部件以指代筒状环和连接件以及支架的其它部件是有益的。
如图2C中最清楚地示出的,各筒状环40限定筒状平面52,该筒状平面52是由该环的近端46和远端48以及筒状环绕着柱体行进的周向范围限定的平面。各筒状环包括限定支架的最外表面的筒状外壁面54和限定支架的最内表面的筒状内壁面56。筒状平面52接着筒状外壁面。
根据本发明,波状连接件50位于筒状平面52内。波状连接件使一个筒状环40与相邻的筒状环40连接,并且由于它们独特的构造而有助于支架的总体纵向柔性。波状连接件的柔性部分源自于连接至直线部分59A和59B的弯曲部分58,其中直线部分大致垂直于支架的纵向轴线。因此,当支架被输送通过诸如冠状动脉的曲折的血管时,波状连接件的弯曲部分58以及直线部分59A和59B将允许支架在纵向上折曲(像铰链一样),这显著地增强了支架向目标治疗部位的输送。连接件中的弯曲部分和直线部分的数量能够与所示数量相比增加或减少,以实现不同的柔性构造。在直线部分大致垂直于支架的纵向轴线的情况下,波状连接件在弯曲部分58处的作用类似于铰链以提供柔性。平行于支架轴线的直线连接件典型地不是柔性的,并且不会增加支架的柔性。
参照图2A至图8,支架38能够被更具体地描述为具有多个第一峰60、第二峰61和谷62。尽管未将支架划分为分离元件,但是为了便于讨论,对峰和谷的指代是适当的。对于各环,能够根据应用来改变峰和谷的数量。因此,例如,如果支架将被植入冠状动脉,则与将支架植入直径大于冠状动脉的直径的外周动脉相比,需要更少数量的峰和谷。例如,在图3中能够观察到,峰60、61是同相的,意味着峰60、61指向相同的方向,并且沿着支架的纵向轴线大致排成一列(aligned)。在某些情况下,可以期望对峰进行定位使得它们异相(未示出),也就是,一个环的峰将与相邻环的峰在周向上错开,使得相邻的峰的顶点指向彼此。如图2A至图8所示,峰与谷64和波状连接件50在周向上错开。以该方式对峰、谷和波状连接件进行定位提供了这样的支架:该支架具有均匀的扩展能力、高径向强度、高度的柔性和足够的壁覆盖以支撑血管。
根据本发明,并且如图2A至图8所示,小直径支架具有0.1575英寸(4.0mm)的最大标称植入直径44。对于小直径支架,各筒状环具有多个第一峰60,第一峰60具有附接到第一顶点67的第一杆臂66。根据具体应用,第一支柱可以是弯曲的或直的。筒状环还具有第二峰61,第二峰61具有附接到第二顶点69的第二杆臂68。同样,根据具体应用,第二杆臂可以是弯曲的或直的。重要的是,第一杆臂66的长度比第二杆臂68的长度长。如图2B所示,当支架处于压接状态或部分压接状态时,第一杆臂和第二杆臂在支架被压缩或压接到导管的球囊或可扩展构件上时将分别靠近彼此。然而,压接或压缩过程还使波状连接件50沿其弯曲部分58靠近第二峰61移动。为了使支架更紧密地压接于导管的球囊部分并避免波状连接件50与第二峰61之间的重叠,第二杆臂68比第一杆臂66短,从而避免了波状连接件50的弯曲部分58与第二峰61之间的任何重叠接触。当支架被压接或压缩时,各种支架杆臂、弯曲部分、连接件以及峰和谷可以彼此接触,而重叠是不期望的特征。
更具体地,为了更紧密地压接或压缩支架38的筒状环40,将波状连接件50紧密地压接或压缩成与第二峰61近接触。例如如图2A至图8所示,弯曲部分58以及直线部分59A和59B与第二峰61紧密相关并且与第二顶点69近接触。连接件的弯曲部分58靠近第二峰61,各环中的第一杆臂66和第二杆臂69被紧密压缩为彼此近接触。例如,第一杆臂66和第二杆臂68以及波状连接件的臂78彼此紧密接触,以便为导管的球囊部分提供压接轮廓非常低的紧密压接的支架。同样,如果支架由诸如镍-钛的自扩展材料形成,则支架将类似地被紧密压接并定位在护套内或导管内以在血管系统中输送。重要的是,波状连接件的弯曲部分和直线部分相对于第二峰定位,以允许支架如所述地被紧密压接。
参照图2A至图8,本发明的支架38也能够被描述为具有由U形部分70、Y形部分72和W形部分74形成的筒状环。同样,虽然通常从管激光切割支架并且支架典型地不具有分立部件,但为了方便识别,本发明的支架还能够被称为具有U形、Y形和W形部分。U形部分70未附接有支撑结构。Y形部分72在其基部或顶点处具有从其延伸的臂76,该臂76附接于波状连接件50。W形部分74在其基部或弯曲部分处具有臂78,该臂78附接在波状连接件的另一端处。将连接件附接于环的臂的长度能够变化。
归因于图3至图5中公开的复杂图案,支架的各种部分(包括U形部分70、Y形部分72和W形部分74)的扩展率能够变化。图3至图5所示的实线是现有技术的支架设计,而虚线示出用于使支架均匀扩展且维持高径向强度的结构构件的内半径的关键改变。因此,本发明的一个方面提供了在各种点处的不同曲率半径,使得支架将均匀且一致地扩展。因此,与第一峰60对应的第一半径80的曲率半径小于与第二峰61对应的第二半径82的曲率半径。通常,与峰相关联的支柱越长,支架的该部分越容易扩展,因此较小的半径与具有较长支柱的峰相关联。同样,诸如第二峰61的峰(其具有比第一峰60的第一杆臂66短的第二杆臂68)具有更容易扩展的较大曲率半径,以便补偿由较短的第二杆臂68产生的较硬的弯曲力矩。
还参照图3至图5,W形部分的各个部分的曲率半径也变化,以提供一致的支架扩展。由于第二峰61及其相关联的第二杆臂68具有随着支架的扩展而更缓慢地扩展的趋势,所以在W形部分74的相邻部件中设置较大的曲率半径。因此,W形部分74的第三半径84大于W形部分中的第四半径86。第三半径84与具有更缓慢扩展的趋势的第二峰61相邻,而第四半径86与具有更容易扩展的趋势的第一峰60相邻。通过改变W形部分中的曲率半径,支架将更均匀地扩展并且补偿筒状环中相邻部分的变化的扩展率。第五半径88对应于Y形部分72的内半径。
在如图2A、图2B以及图6至图8所示的一个实施方式中,用于体腔的柔性血管内支架38包括多个筒状环40,多个筒状环40具有远端筒状环90、近端筒状环92和多个主体筒状环94,所有的筒状环沿着共同的纵向轴线排列并且互连以形成支架。各筒状环具有输送直径44和植入直径42。各筒状环具有多个通过第一杆臂66连接的第一峰60和多个通过第二杆臂68连接的第二峰61,各杆臂具有长度,第二杆臂68比第一杆臂66短。至少一个波状连接件50使各筒状环40附接到相邻的筒状环,波状连接件具有朝向第二峰61的横向于支架的纵向轴线延伸的弯曲部分58,第二峰61的高度被尺寸化为当支架被压缩到输送直径44时,波状连接件50的弯曲部分58在纵向上与第二峰61排成一列并邻近第二峰61。远端筒状环90具有用于第一杆臂66的第一宽度96和用于第二杆臂68的第二宽度98。各波状连接件50具有长臂78和短臂76,长臂78沿其长度具有多个略弯曲部100。沿着长臂78的长度的多个略弯曲部100有助于波状连接件50保持轴向排成一列,并防止在压接和扩展期间的摇摆。主体筒状环94具有用于第三组杆臂106的第三宽度104和用于第四组杆臂110的第四宽度108。近端筒状环92具有用于第五组杆臂116的第五杆臂宽度114。远端筒状环90上的多个第一峰120和多个第二峰122具有不超过68微米(0.0268英寸)的内半径124。主体筒状环94上的多个第一峰126和多个第二峰128具有不超过50微米(0.00197英寸)的内半径130。归因于对内半径124和130的设计的改进,输送直径44减小到0.754mm(0.0297英寸)。
在另一实施方式中,如图2A、图2B以及图6至图8所示,用于体腔的柔性血管内支架38包括多个筒状环40,多个筒状环40具有远端筒状环90、近端筒状环92和多个主体筒状环94,所有的筒状环沿着共同的纵向轴线排列并且互连以形成支架。各筒状环具有第一输送直径44和第二植入直径42。各筒状环具有多个通过第一杆臂66连接的第一峰60和多个通过第二杆臂68连接的第二峰61,各杆臂具有长度,第二杆臂68比第一杆臂66短。至少一个波状连接件50使各筒状环40附接到相邻的筒状环,波状连接件具有朝向第二峰61的横向于支架的纵向轴线延伸的弯曲部分58,第二峰61的高度被尺寸化为当支架被压缩到输送直径44时,波状连接件50的弯曲部分58在纵向上与第二峰61排成一列并邻近第二峰61。远端筒状环90和多个主体筒状环94具有相同宽度的杆臂。各波状连接件50具有长臂78和短臂76,长臂78沿其长度具有多个略弯曲部100。沿着长臂78的长度的多个略弯曲部100有助于波状连接件50保持轴向排成一列,并防止在压接和扩展期间的摇摆。近端筒状环92具有比远端筒状环90和多个主体筒状环94的杆臂宽度大的杆臂宽度。第二近端筒状环140(图8)具有第六组杆臂142和第七组杆臂146,第六组杆臂142具有第六宽度144,第七组杆臂146具有第七宽度148。远端筒状环90上的多个第一峰120和多个第二峰122具有不超过68微米(0.0268英寸)的内半径124。主体筒状环94上的多个第一峰126和多个第二峰128具有不超过50微米(0.00197英寸)的内半径130。归因于对内半径124和130的设计的改进,输送直径44减小到0.754mm(0.0297英寸)。
在图9A至图13所示的实施方式中,用于体腔的中间直径柔性血管内支架150包括多个筒状环152,多个筒状环152具有远端筒状环154、近端筒状环156和多个主体筒状环158,所有的筒状环都沿着共同的纵向轴线排列并互连以形成支架。各柱环具有第一输送直径160和第二植入直径162。至少一些主体筒状环152具有多个通过第一杆臂166连接的第一峰164和通过第二杆臂170连接的第二峰168。各杆臂具有长度,第二峰168的第二杆臂170比第一峰164的第一杆臂166短。至少一个波状连接件172使各筒状环152附接于相邻的筒状环152,波状连接件具有朝向第二峰168的横向于支架的纵向轴线延伸的铰链174,第二峰的高度被尺寸化为当支架被压缩至第一输送直径时,波状连接件172的铰链174在纵向上与第二峰168排成一列并邻近第二峰168。远端筒状环154、近端筒状环156和主体筒状环158的杆臂176具有相同的宽度178。各波状连接件172具有长臂180和短臂182,长臂180沿其长度具有多个略弯曲部184。第二近端筒状环186具有第一组杆臂188和第二组杆臂192,第一组杆臂188具有第一宽度190,第二组杆臂192具有第二宽度194。远端筒状环154上的多个第一峰164和多个第二峰168具有不超过68微米(0.0268英寸)的内半径196。主体筒状环158上的多个第一峰164和多个第二峰168具有不超过50微米(0.00197英寸)的内半径198。
本发明的支架能够安装于现有技术中众所周知的球囊导管。支架被紧密压缩或压接于导管的球囊部分并且在输送通过患者的血管内系统期间保持紧密压接于球囊。当球囊扩展时,支架径向向外扩展以与体腔(例如,冠状动脉)接触。当导管的球囊部分放气(deflated)时,导管系统从患者撤回,并且支架保持植入在动脉中。类似地,如果本发明的支架由诸如镍-钛等的自扩展金属合金制成,则支架可以压缩或压接于导管,并且将护套(未示出)放置于支架以将支架保持就位直到准备好将支架植入患者。这种护套在现有技术中是众所周知的。此外,这种自扩展支架可以压缩或压接到输送直径并放置在导管内。一旦支架被定位在动脉内,支架就被推出导管或向近端撤回导管护套,并且支架被保持就位直到支架离开导管并自扩展到与动脉壁接触。球囊导管和用于输送自扩展支架的导管在现有技术中众所周知。
本发明的支架能够以多种方式制成。一种制造支架的方法是切割薄壁的管状构件(诸如钴-铬合金管),以用于支架的期望图案移除管中的一些部分,而留下金属管的待形成支架的部分相对不触碰。支架还能够由诸如钽、镍-钛合金、不锈钢、钛、形状记忆和超弹性合金的其它金属合金以及诸如金或铂的贵金属制成。根据本发明,优选的是,借助于现有技术中众所周知的机器控制的激光来以期望的图案切割管。
本发明的支架还能够由除了不锈钢之外的金属合金(诸如形状记忆合金)制成。形状记忆合金众所周知并且包括但不限于镍-钛和镍-钛-钒。任何形状记忆合金都可以形成为管并被激光切割以便形成本发明的支架的图案。众所周知,本发明的支架的形状记忆合金能够包括具有超弹性或热弹性马氏体相变或表现出应力诱导的马氏体的类型。这些类型的合金在现有技术中是众所周知的而且在这里不需要进一步描述。
重要的是,由形状记忆合金形成的支架(无论是热弹性的还是应力诱导的马氏体型)能够使用本文所述类型的球囊导管或不具有球囊的导管或护套导管来输送。
尽管已经在本文中图示并描述了本发明,但是就其作为血管内支架的用途而言,对于本领域技术人员而言显而易见的是,该支架能够用于其它体腔。此外,本文已经仅作为示例描述并提供了具体尺寸和大小、每个环中的波状或U形部分的数量、所使用的材料等。在不脱离本发明的范围的情况下,可以进行其它变型和改进。

Claims (21)

1.一种用于体腔的柔性血管内支架,其包括:
多个筒状环,其包括远端筒状环、近端筒状环和多个主体筒状环,所有的筒状环沿着共同的纵向轴线排列并互连以形成所述支架,各筒状环具有第一输送直径和第二植入直径;
各筒状环具有多个通过杆臂连接的第一峰和多个通过杆臂连接的第二峰,各所述杆臂具有长度,所述第二峰的杆臂比所述第一峰的杆臂短;
至少一个波状连接件,其使各筒状环附接于相邻的筒状环,所述波状连接件具有朝向所述第二峰的横向于所述支架的纵向轴线延伸的弯曲部分,所述第二峰的高度被尺寸化为当所述支架被压缩到所述第一输送直径时,所述波状连接件的弯曲部分在纵向上与所述第二峰排成一列并邻近所述第二峰;
所述远端筒状环具有用于第一组杆臂的第一宽度和用于第二组杆臂的第二宽度;并且
各波状连接件具有第一臂和第二臂,所述第一臂沿其长度具有多个略弯曲部,并且所述第一杆臂比所述第二杆臂长。
2.根据权利要求1所述的支架,其特征在于,波状连接件的第一臂和第二臂与所述支架的纵向轴线大致平行。
3.根据权利要求2所述的支架,其特征在于,所述主体筒状环具有用于第三组杆臂的第三宽度和用于第四组杆臂的第四宽度。
4.根据权利要求2所述的支架,其特征在于,所述近端筒状环具有用于第五组杆臂的第五杆臂宽度。
5.根据权利要求1所述的支架,其特征在于,所述远端筒状环上的多个所述第一峰和多个所述第二峰具有不超过68微米(0.0268英寸)的内半径。
6.根据权利要求1所述的支架,其特征在于,所述主体筒状环上的多个所述第一峰和多个所述第二峰具有不超过50微米(0.00197英寸)的内半径。
7.根据权利要求1所述的支架,其特征在于,各筒状环的所述第一峰与相邻的筒状环的所述第一峰同相。
8.根据权利要求1所述的支架,其特征在于,所述波状连接件被构造为向所述支架提供柔性。
9.根据权利要求1所述的支架,其特征在于,所述支架由管形成。
10.根据权利要求1所述的支架,其特征在于,所述支架由金属合金形成。
11.根据权利要求10所述的支架,其特征在于,所述支架由不锈钢、钽、镍-钛、钴-铬和钛构成的金属合金组中的任一者形成。
12.根据权利要求1所述的支架,其特征在于,所述支架涂覆有治疗药物。
13.一种用于体腔的柔性血管内支架,其包括:
多个筒状环,其包括远端筒状环、近端筒状环和多个主体筒状环,所有的筒状环沿着共同的纵向轴线排列并互连以形成所述支架,各筒状环具有第一输送直径和第二植入直径;
各筒状环具有多个通过杆臂连接的第一峰和多个通过杆臂连接的第二峰,各所述杆臂具有长度,所述第二峰的杆臂比所述第一峰的杆臂短;
至少一个波状连接件,其使各筒状环附接于相邻的筒状环,所述波状连接件具有朝向所述第二峰的横向于所述支架的纵向轴线延伸的弯曲部分,所述第二峰的高度被尺寸化为当所述支架被压缩到所述第一输送直径时,所述波状连接件的弯曲部分在纵向上与所述第二峰排成一列并邻近所述第二峰;
所述远端筒状环和多个所述主体筒状环具有宽度相同的杆臂;并且
各波状连接件具有第一臂和第二臂,所述第一臂沿其长度具有多个略弯曲部,并且所述第一臂比所述第二杆臂长。
14.根据权利要求13所述的支架,其特征在于,所述近端筒状环的杆臂宽度大于所述远端筒状环的杆臂宽度和多个所述主体筒状环的杆臂宽度。
15.根据权利要求13所述的支架,其特征在于,第二近端筒状环具有第一组杆臂和第二组杆臂,所述第一组杆臂具有第一宽度,所述第二组杆臂具有第二宽度。
16.根据权利要求13所述的支架,其特征在于,所述远端筒状环上的多个所述第一峰和多个所述第二峰具有不超过68微米(0.0268英寸)的内半径。
17.根据权利要求13所述的支架,其特征在于,所述主体筒状环上的多个所述第一峰和多个所述第二峰具有不超过50微米(0.00197英寸)的内半径。
18.一种用于体腔的柔性血管内支架,其包括:
多个筒状环,其包括远端筒状环、近端筒状环和多个主体筒状环,所有的筒状环沿着共同的纵向轴线排列并互连以形成所述支架,各筒状环具有第一输送直径和第二植入直径;
各筒状环具有多个通过杆臂连接的第一峰和多个通过杆臂连接的第二峰,各所述杆臂具有长度,所述第二峰的杆臂比所述第一峰的杆臂短;
至少一个波状连接件,其使各筒状环附接于相邻的筒状环,所述波状连接件具有朝向所述第二峰的横向于所述支架的纵向轴线延伸的弯曲部分,所述第二峰的高度被尺寸化为当所述支架被压缩到所述第一输送直径时,所述波状连接件的弯曲部分在纵向上与所述第二峰排成一列并邻近所述第二峰;
所述远端筒状环、所述近端筒状环和所述主体筒状环具有宽度相同的杆臂;并且
各波状连接件具有第一臂和第二臂,所述第一臂沿其长度具有多个略弯曲部,并且所述第一臂比所述第二臂长。
19.根据权利要求18所述的支架,其特征在于,第二近端筒状环具有第一组杆臂和第二组杆臂,所述第一组杆臂具有第一宽度,所述第二组杆臂具有第二宽度。
20.根据权利要求18所述的支架,其特征在于,所述远端筒状环上的多个所述第一峰和多个所述第二峰具有不超过68微米(0.0268英寸)的内半径。
21.根据权利要求18所述的支架,其特征在于,所述主体筒状环上的多个所述第一峰和多个所述第二峰具有不超过50微米(0.00197英寸)的内半径。
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