CN102227194B - 可再约束的支架递送系统 - Google Patents

可再约束的支架递送系统 Download PDF

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CN102227194B
CN102227194B CN200980147615.4A CN200980147615A CN102227194B CN 102227194 B CN102227194 B CN 102227194B CN 200980147615 A CN200980147615 A CN 200980147615A CN 102227194 B CN102227194 B CN 102227194B
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CN102227194A (zh
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B·比奇
珍妮特·伯皮
安德鲁·费莱奇克
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Flexible Stenting Solutions 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
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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
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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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    • 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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Abstract

本发明的支架结合了通过线圈元件互连的螺旋支撑带。这种结构提供了期望的支架属性的组合，例如，大体上的柔性，支撑血管腔的稳定性，格栅尺寸和径向强度。本发明的支架的这种结构提供了螺旋支撑带和互连的线圈之间的预定几何关系。

Description

可再约束的支架递送系统
技术领域
本发明涉及自展式支架和自展式支架的递送系统。该递送系统允许将支架再次约束到递送导管，同时，如果需要，允许支架改变长度并在递送导管内旋转。本发明还涉及缩短可观的量(例如大于大约10％)的自展式支架的递送系统。
背景技术
大多数商用自展式支架被设计成，一旦支架开始扩张进入目标血管、动脉、输送管或身体管腔，就不可再取回(再约束)到递送系统。倘若支架被置于不正确或非最优位置，在支架开始展开后能够将其重新取回是有利地，支架能够被取回和再次展开或被取回和撤去。相比于不可再取回的支架和递送系统，可再取回的支架和递送系统具有较大的安全性优势。
许多传统的自展式支架被设计成将支架缩短限制到一个不可观的量。支架缩短是支架长度方面从卷曲或径向压缩状态(当在递送导管中或递送导管上承载支架时)到扩张状态的变化。百分比缩短通常被定义为递送导管负载状态(卷曲)和大至最大标示直径的展开直径之间的支架长度变化除以支架在递送导管负载状态(卷曲)下的长度。当在身体管腔或体腔(例如血管、动脉、静脉或输送管)内展开时，缩短可观的量的支架遇到了更多困难。随着支架在身体管腔或体腔内展开，支架的远端具有向近端方向移动的趋势。缩短可导致支架被置于不正确或非最优位置。相比于比不补偿支架缩短的递送系统，可补偿支架缩短的递送系统具有很多优点。
支架是管状结构，其在径向压缩或卷曲状态下可被插入到活体中的有限的空间内，例如输送管、动脉或其他血管。插入后，支架可在目标位置径向扩张。支架通常被描述为球囊扩张(BX)或自扩张(SX)。球囊扩张支架需要球囊以从内部扩张支架并扩大血管，球囊通常是递送系统的一部分。通过材料、尺寸或制造工艺的选择，自展式支架被设计成一旦释放到期望血管就从卷曲状态扩张到扩张状态。在某些情况下，需要比自展式支架扩张力大的力以扩张病变血管。在这种情况下，可使用球囊或类似设备以辅助自展式支架的扩张。
支架通常用于治疗血管或非血管疾病。例如，卷曲的支架可被插入到阻塞的动脉中并随后被扩张，从而恢复动脉中的血管流。在释放前，支架通常在导管等中保持卷曲状态。一旦步骤完成，支架就呈扩张状态留在患者动脉内。患者的健康，有时甚至是生命，取决于支架维持在其扩张状态的能力。
许多传统支架在卷曲状态下是柔性地以有助于支架例如在动脉中的递送。在展开和扩张后几乎没有支架是柔性的。另外，在一些应用中，在展开后，支架可以经历大体上柔性或弯曲的、轴向压缩和在沿其长度方向的点上的重复位移(例如对股浅动脉进行支架植入术时)的过程。这可产生过度收紧或疲劳，导致支架的失效。
对于类支架结构，也存在类似的问题。一个实例是与基于导管的阀递送系统中的其他元件一起使用的类支架结构。这样的类支架结构保持置于血管中的阀。
发明内容
本发明包括自展式支架的导管递送系统。本发明的可再约束的支架递送系统包括近端和远端，其包括内部元件和外部元件，通常是轴或导管或导管的外部鞘，其卷曲到支架近端的滑块上。滑块可绕内部轴或管(如导线管)中的一个旋转或沿其纵向移动，使得当支架展开时，支架的近端可向远端移动。推动器可用在导线管上，从而导线管、推动器和支架相对于外部鞘向近端移动并将支架再约束在外部鞘内。此外，当外部鞘向近端收缩以展开支架时，推动器和导线管可向远端移动以有帮助缩短。
递送系统也可包括导管递送系统中的弹性元件，该弹性元件在支架展开期间将作用于支架近端的轴向负载。所述的弹性元件可使递送导管内的支架的轴向移动偏移，从而在支架展开时，向远端移动。由于偏移的移动降低了支架展开期间支架远端的移动量，这种偏移的移动对于缩短可观的量的支架来说是有利的。
导管递送系统可用于展开在髂、股、腘、颈动脉、神经血管或冠状动脉血管内的治疗各种血管疾病状态的支架。
本发明的支架结合了通过线圈元件互连的螺旋支撑元件或带。这种结构提供了期望的支架属性的组合，例如，大体上的柔性，支撑血管腔的稳定性，格栅尺寸和径向强度。但是使螺旋支撑带互连的线圈元件的增加使支架的直径状态的变化更加复杂。通常，支架结构必须能够改变支架的直径大小。例如，支架通常以小直径尺寸状态递送到动脉中的目标病变位置，然后在动脉中的目标病变位置处扩张到较大直径尺寸状态。本发明的支架的这种结构提供了螺旋支撑带和互连的线圈元件之间的预定几何关系，从而维持了支架的任意直径尺寸状态的互通性。
本发明的支架是由极具弹性的镍钛诺制成的自展式支架。这种类型的支架在完全扩张或未约束状态下具有特定结构。此外，这种类型的支架必须能够径向压缩到较小的直径，该直径有时被称为卷曲直径。径向将支架压缩到较小直径有时也被称为卷曲支架。自展式支架的直径在完全扩张或未约束直径和卷曲直径之间的差值可以比较大。完全扩张直径比卷曲直径大3-4倍是正常的。通过选择材料、形状和制造工艺将自展式支架设计成：一旦支架释放到目标血管，其就从卷曲直径扩张到扩张直径。
本发明的支架包括螺旋地绕着所述支撑的轴卷绕的螺旋支撑带。螺旋支撑带包括支撑元件的波浪形状，波浪形状在所述波浪形状的每一侧均具有多个波峰。多个线圈元件螺旋地绕着所述支架的轴卷绕，线圈元件沿与所述螺旋支撑带相同的方向前进。线圈元件通常是细长的，其长度远大于宽度。线圈元件将第一卷绕的至少一些支撑元件在波浪形状的波峰或靠近波峰处互连到螺旋支撑带的第二卷绕的至少一些支撑元件。在本发明的支架中，构建有几何关系三角，该几何关系三角具有：第一边，其边长LC是所述螺旋支撑带的第一卷绕和第二卷绕的互连波峰之间的所述线圈元件的有效长度；第二边，其边长是通过所述线圈元件互连的第一卷绕的波峰和第二卷绕的波峰之间的周向距离除以所述支架的纵轴和所述螺旋支撑带所成的角As的正弦值；第三边，其边长是所述螺旋支撑带在一周卷绕中前进的纵向距离(Pl)减去有效支撑长度Ls；第一边的第一角，其是180度减去所述角As；第二边的第二角，其是从纵轴测量的线圈元件绕支架的轴前进的角Ac；以及第三边的第三角，其是所述角As减去所述角Ac，其中，第一边长LC与长度LS的比率再乘以形成螺旋支撑带的支撑元件的波浪形状的数量NS，NS大约大于或等于1。该值定义为线圈-支撑比率，并且数值上表示为：线圈-支撑比率＝Lc/Ls*Ns。
附图说明
从下文的对根据本明的优选但说明性实施方式的详细说明，并结合附图，将更加完整地理解本发明的前述说明和其他目的、特征及优点，附图中：
图1是根据本发明的支架递送系统的示意图。
图2是在支架展开前图1中示出的X-X段的详细放大示图。
图3是在取回前图1中示出的X-X段的详细放大示图。
图4是具有替代实施方式配置的图1中示出的X-X段的详细放大示图。
图5是具有替代实施方式配置的图1中示出的X-X段的详细放大示图。
图6是具有替代实施方式配置的图5中示出的Z-Z截面的示图。
图7是在支架开始展开前图1中示出的X-X段的详细放大示图。
图8是在支架展开期间图1中示出的X-X段的详细放大示图。
图9是根据本发明的支架递送系统的示意图。
图10是根据本发明的支架的第一实施方式的平面图，支架被示出处于部分扩张状态。
图11是图1中的部分A的详细放大示图。
图12是支架的一种替代实施方式的平面图。
图13是图3中所示的部分B的详细放大示图。
图14是支架的一种替代实施方式的平面图。
图15是支架的一种替代实施方式的平面图。
图16是支架的一种替代实施方式的平面图。
图17是图7中的部分C的详细放大示图。
图18是支架的一种替代实施方式的平面图。
图19是支架的线圈元件的替代实施方式的示意图。
图20是图14的部分D的详细放大示图。
图21是具有替代实施方式配置的图1中示出的X-X段的详细放大示图。
具体实施方式
图1示出了本发明的自展式支架递送系统10，其由内部和外部轴元件组成，例如轴或管。外管也被称为外部鞘11，其约束卷曲或径向压缩状态下的支架12。内部元件可由多个元件组成，多个元件包括：远尖端8、导线管14和推动器16，随着外部鞘为展开支架而收缩，推动器16对施加在支架上的轴向力起作用。推动器16也可作为近端止挡部。支架递送系统的其他元件可包括：附加到推动器16近端的鲁尔(Luer)锁紧毂6、附加到外部鞘11的把手3，外部鞘11合并鲁尔(Luer)口4，从而内部元件和外部鞘11之间的空间可被盐水溶液冲洗以移除任何夹带空气。推动器16往往是多个元件的组合结构，例如近端为不锈钢管，外部鞘11内部是聚合物管。
图2示出的X-X段的详细示图，本发明的支架递送系统10由外部鞘11、递送导管组成，处于卷曲或径向压缩状态的支架12被约束在递送导管中。支架递送系统10可以被认为是作为递送导管的导管递送系统。滑块13设置在与卷曲的支架12的内径连接的位置处。滑块13与导线管14同轴，并且滑块13相对于导线管14自由旋转和滑动。远端止挡部15固定到导线管14远离滑块13的位置处。推动器16置于靠近支架12和滑块13的位置，由于外部鞘11收缩以展开支架，推动器16对传送到支架的轴向力起作用并提供近端止挡部。由于外部鞘11收缩和支架12展开，支架12和滑块13可在外部鞘11内相对于导线管14自由移动、平移或旋转。当支架设计是支架12随着其从卷曲状态扩张为较大直径扩张状态而长度缩短和/或旋转时，这是有利的。本发明的递送系统允许支架在外部鞘11内移动，而不是在身体管腔内移动。在外部鞘11完全收缩并由此释放支架12前，可通过下述方法将支架重新取回：相对于支架12和滑块13向近端移动导线管14和附加的远端止挡部15，直到远端止挡部15接触滑块13，如图3的X-X段的详细示图所示。由于支架12和滑块13彼此紧密接触，外部鞘11可相对于支架12、滑块13、导线管14和远端止挡部15向远端移动，由此重新取回外部鞘11内的支架12。在这种实施方式中，由于外部鞘11收缩以展开支架12，推动器16与支架12接触。
在替代实施方式中，滑块13设计成与支架12的内径连接并由于外部鞘11收缩而与推动器16接触，如图4所示。这种实施方式降低了在支架展开期间直接置于支架12上的轴向负载。
在上述实施方式中，滑块13与导线管14同轴，并且滑块13可相对于导线管14自由旋转和滑动。导线管14可以是中空的，形成长度相当于支架递送系统的长度的腔室以适应引导线，引导线通常用于帮助支架递送系统定位在目标血管、动脉、输送管或身体管腔内。可选地，导线管14可以是非中空的固体轴18，如图5所示。
在一种替代实施方式中，近端止挡部19对支架近端的轴向力起作用，近端止挡部19附着到非中空轴18，从而近端止挡部19和非中空轴是如图21所示的单一元件。近端止挡部19和非中空轴18可由添加在一起的不同材料制成，或者可由相同材料制成。
在图6的Z-Z截面图中示出的替代实施方式中，滑块13由下述结构形成：滑块13的一部分是塑模或形成在支架12的内径21和/或支架12的侧壁22上的聚合物。滑块13可以是包括聚合物部分23的复合或层状结构，聚合物部分23在靠近滑块13的内径处与支架12和硬质部分24连接。
在图7和图8的X-X段的详细示图中所示出另一种实施方式中，弹性元件25结合到推动器16中，从而随着支架12的近端的轴向力的增加，弹性元件25被压缩，直到外部鞘11开始相对于支架12沿近端方向移动。随着支架12展开，弹性元件25继续对支架12近端的轴向负载起作用，并同时由于支架12从外部鞘11中缩短出来，将支架12的近端推向远端。图7示出了在支架12开始展开之前处于未压缩状态的弹性元件25，其中支架12未承受轴向负载。图8示出了在开始展开之后处于压缩状态的弹性元件25，其中支架12承受轴向负载，X2＜X1。随着支架12扩张出外部鞘11，支架12上的轴向负载通常将从开始展开附近的峰值负载下降。随着轴向负载下降，由于缩短发生在支架12的近端，弹力将向前推动支架12的近端以偏移支架12的任何移动，从而支架12的近端向远端移动，而不是支架12的远端向近端移动。
在一种替代实施方式中，弹性元件26可结合在支架递送系统10的近端，其中弹性元件26的远端27有效地与推动器16连接，弹性元件26的近端28固定，从而随着支架12近端的轴向力增加，推动器16压缩弹性元件26，直到外部鞘11开始相对于支架12沿近端方向移动。随着支架12的展开，由于支架12从外部鞘11中缩短出来，弹性元件26向近端移动推动器16。
图10以及图11中的细节示出了可用于支架递送系统10的支架500。图10是根据本发明教导的处于部分扩张状态的支架500的第一实施方式的平面图。如本文所使用的，术语“平面图”将被理解为描述展开的平面图。这可以认为是沿平行于轴线的直线切开并平铺的管状支架。因此，应该注意，在实际支架中，图10的上边缘将与下边缘接合。支架500由螺旋支撑带502组成，螺旋支撑带502通过线圈元件507相互连接。并行的线圈元件507形成线圈带510。线圈带510形成为具有螺旋支撑带502的双螺旋线，并且从支架的一端绕到另一端。螺旋支撑带502包括波浪形状的支撑元件503，支撑元件503在波浪形状的每一侧上具有波峰508并在波峰508之间具有边509。线圈元件507与螺旋支撑带502的支撑元件503通过波峰508相互连接或在波峰508附近相互连接。由于螺旋支撑带502绕支架500前进，螺旋支撑带502的NSC部分505由螺旋支撑带502的在线圈元件507之间的支撑元件503的数量(NSC)定义。在螺旋支撑带502的NSC部分505中的支撑元件503的数量(NSC)大于在螺旋支撑带502的一周卷绕中支撑元件503的数量(N)。在NSC部分505中的支撑元件503的数量(NSC)是恒定的。
在这种实施方式中，支架500在卷绕螺旋支撑带502的一周上具有N＝12.728个螺旋支撑元件503，并且在NSC部分505上具有NSC＝16.5个螺旋支撑元件503。螺旋支撑带502的NSC部分505的CCDn部分512由支撑元件503的数量(CCDn)确定，该数量等于NSC减去N。CCDn部分512中的支撑元件503的数量(CCDn)和卷绕螺旋支撑带502的一周的支撑元件503的数量(N)在支架500不同的直径尺寸下可以不相同。支架500在CCDn部分512中具有CCDn＝3.772个螺旋支撑元件503。由于需要在任意直径尺寸状态下维持这种连通性，螺旋支撑带502和线圈元件507之间的几何关系可通过几何关系三角511来描述。几何关系三角511具有：第一边516，其边长等于线圈元件507的有效长度(Lc)530；第二边513，其边长等于螺旋支撑带502的CCDn部分512的周向线圈距离(CCD)531除以支架500的纵轴和螺旋支撑带502之间的角As535的正弦值；第三边514，其边长(SS)532等于螺旋支撑带502在一周卷绕中前进的纵向距离(Pl)534减去去有效支撑长度LS 533；第一边516的第一角537，其等于180度减去角As535；第二边513的第二角536，其等于线圈元件507与支架500的纵轴所成的角Ac536；以及第三边514的第三角538，其等于角As 535减去角Ac536。如果螺旋支撑元件503的周向支撑距离(Ps)539对于CCDn部分512中的所有螺旋支撑元件503都是相同的，周向线圈距离CCD 531等于CCDn部分512中的螺旋支撑元件503的数量乘以周向支撑距离Ps539。在示出了支架平面示图的任一图中的距离表示支架表面上的距离，例如垂直距离是周向距离，成角度的距离是螺旋距离。几何关系三角511的第一边516示出为与线圈元件507的线性部分平行，从而线圈角Ac 536等于线圈元件507的线性部分的角度。如果线圈元件507不具有大体上呈线性的部分，而以螺旋的方式绕支架前进，等效线圈角536可用于构建几何关系三角511。例如，如图19所示，如果线圈元件507是波浪线圈元件907，线901可被示出为通过波浪线圈元件907的曲线，并且线901可被用于定义线圈角536。
图12和13示出的支架400与支架500类似，其由通过线圈元件507互连的螺旋支撑带402组成。支架400的不同点在于：螺旋支撑带402由两个相邻的波浪形状的支撑元件403a和403b组成，支撑元件403a和403b在波浪形状的每一侧均具有波峰508。支撑元件403a连接到支撑元件403b。类似于螺旋支撑带502，螺旋支撑带402也具有NSC部分405和CCDn部分412。螺旋支撑带402可被定义为具有Ns(等于2)个支撑元件的波浪形状。螺旋支撑带502可被定义为具有Ns(等于1)个支撑元件的波浪形状。在替代实施方式中，本发明的支架可具有带有Ns(等于3)个支撑元件的波浪形状的螺旋支撑带，这可以是三重支撑带。在替代实施方式中，本发明的支架可具有带有Ns(等于任意整数)个支撑元件的波浪形状的螺旋支撑带。具有带有Ns(大于等于2)个支撑元件的波浪形状的螺旋支撑带的支架是有利的，这是因为螺旋支撑带会形成具有较小栅格尺寸的闭合栅格结构，当存在额外栓塞风险时，这是所期望的。相比于具有较大栅格尺寸的支架而言，具有较小栅格尺寸的支架更趋向于捕获血小板或其他栓塞碎屑。
当线圈-支撑比率，即Lc与Ls的比率再乘以螺旋支撑带中支撑元件的波浪形状的数量Ns(Lc乘以Ns再除以Ls)，大于或等于1时，所述的支架结构提供了期望的支架属性的组合。例如，支架500的线圈-支撑比率为2.06，支架400的线圈-支撑比率为2.02。图18中示出的支架200具有类似于支架500的结构。支架200的线圈-支撑比率大约为1.11。
为了使本发明的支架卷曲到较小直径，结构的尺寸产生了一些变化。由于螺旋支撑带的螺旋性质，随着支架直径减小，支撑角As必须变小。由于线圈元件产生的螺旋支撑带的第一卷绕和螺旋支撑带的第二卷绕之间的互通性，元件的角度Ac也必须变小或者变窄，以适应较小的支撑角As。如果线圈元件的角度Ac不能或难以随着支架卷曲和支撑角As变小而变窄，线圈元件将趋向于彼此连接并防止卷曲，或者趋向于需要更大的力才卷曲。如果线圈-支撑比率大于1，则有助于线圈元件的角度在卷曲期间变化。线圈-支撑比率小于1趋向于使线圈元件变硬，从而需要更大的力才能在卷曲过程中将线圈元件弯曲到较窄的角度，但这并不是所期望的。
如图14所示，支架600的螺旋支撑带602过渡到支撑部622并继续作为端支撑部622，其中支撑元件624a的形成端支撑部622的波浪形状的卷绕角度AT1大于螺旋支撑带的角度As。端支撑部622包括支撑元件624b的波浪形状的第二卷绕，其中第二卷绕的角度AT2大于第一卷绕的角度AT1。螺旋支撑带602的支撑元件603通过一系列定义过渡线圈部分621的过渡线圈元件623互连到端支撑部622的第一卷绕的支撑元件624a上。端部622的第一卷绕的所有支撑元件624a通过线圈元件623连接到螺旋支撑带602。螺旋支撑带602的波峰602未连接到端支撑部622。过渡线圈部分621允许端支撑部622具有大体上平的端部625。支架400的螺旋支撑带402过渡到端部并继续作为端部，其中形成端部的支撑元件的波浪形状的第一卷绕角度大于螺旋支撑带的角度As。第二卷绕角度AT2大于AT1，端部的后续卷绕的角度也增大(即AT1＜AT2＜AT3＜AT4)。如图20所示，支架600包括端支撑部622的一个波峰626，该波峰通过过渡线圈元件623连接到螺旋支撑带602的两个波峰。
所附标记描述如下：
·(N)-螺旋支撑元件在螺旋支撑元件的一周卷绕中的数量。
·(As)-从支架的纵轴测量的螺旋支撑带卷绕的角度。
·(Ac)-从支架的纵轴测量的线圈元件的有效角度。
·(Pl)-支撑元件在一周卷绕中前进的纵向距离(间距)。等于支架的周长除以As的反正切值。
·(Ps)-螺旋支撑带的螺旋支撑元件的支撑边之间的周向距离(间距)。假设周向支撑间距对于螺旋支撑带的所有支撑元件都是相同的，则周向支撑间距等于支架的周长除以N。
·(NSC)-随着支撑元件前进，螺旋元件之间的支撑带的支撑元件的数量。
·(CCDn)-互连的支撑元件之间的支撑带的支撑元件的数量，等于NSC减去N。
·(CCD)-周向线圈距离是互连的支撑元件之间的周向距离，如果Ps对于CCDn部分中的所有支撑元件都是相同的，则CCD等于CCDn乘以Ps。
·(Lc)-由表1中的几何关系三角定义的螺旋元件的有效长度。
·(SS)-由表1中的几何关系三角定义的支撑间隔。
·(Ls)-有效支撑长度，等于Pl减去SS。
·(Ns)-形成螺旋支撑带的支撑元件的相邻波浪形状的数量。
·线圈-支撑比率-LC与长度LS的比率乘以形成螺旋支撑带的支撑元件的相邻波浪形状的数量NS。在数值上等于Lc/Ls*Ns。
·支撑长度-支撑间隔比率-有效支撑长度(Ls)和支撑间隔(SS)的比率，在数值上等于Ls/SS。
在一种实施方式中，支撑角As和线圈角Ac之间的差大于大约20度。由于线圈角必然要由于支架卷曲而变窄，如果扩张状态下的线圈角和支撑角彼此太接近，则卷曲支架的难度增加。
对于本发明的支架而言，支撑长度-支撑间隔比率是支撑角度和线圈角度的相对角度的量度。支撑长度-支撑间隔比率小于大约2.5的支架具有改进的卷曲性能。如果在扩张状态下支撑元件的角度在55度到80度之间且线圈角度在45度到60度之间，则能够进一步改进支架属性。此外，扩张状态下较陡的线圈角Ac使得卷曲本发明的支架更加困难。在扩张状态下小于60度的线圈角有助于卷曲本发明的支架。
对于本发明的支架而言，除了卷曲期间线圈角的变化之外，螺旋支撑带绕支架的纵轴旋转以适应螺旋支撑带在卷曲期间的后续卷绕之间的连通性，后续卷绕使得在卷曲支架时，更多的螺旋支撑带沿着支架的长度卷绕。在一种实施方式中，螺旋支撑带的纵向间距(Pl)在扩张状态和卷曲状态下大致相同。考虑到当卷曲支架时，螺旋支撑带沿支架长度卷绕的增加有助于缩短支架，因此对于本发明的支架来说，在卷曲时螺旋支撑带卷绕的量大约增加小于30％是有利的，优选地小于大约26％。螺旋支撑带的卷绕增加26％对应于大约20％的缩短，这被认为是最大临床有益缩短量(Serruys，Patrick，W.和Kutryk，Michae1，J.B.，Eds.Handbook of CoronaryStents，第二版Martin Dunitz Ltd.，伦敦，1998)，通过引用将此文全文并入本申请中。
图15是根据本发明教导的支架700的另一实施方式的平面图。螺旋支撑带702从支架700的一端螺旋前进到另一端。每个支撑元件703通过线圈元件707连接到螺旋支撑带702的后续卷绕的支撑上。支撑元件703包括边部分709。每一边部分709具有相等的长度。
图16是支架800的另一实施方式的平面图，其在图17中详细示出。在这种实施方式中，绕圈元件807在端部853和854包括弯曲的过渡部852。弯曲的过渡部852连接到支撑元件803。
支架800包括过渡螺旋部859和在支架800的第一端861的端支撑部858。端支撑部858由一对连接的支撑卷绕860形成。线圈元件807由两个线圈部分807a和807b组成，线圈部分807a和807b由间隙808隔开，如图17所示。间隙808的大小可等于0，其中线圈部分807a和807b接触。间隙808在端部853和854处终止。间隙808可在沿线圈807长度方向上的任意位置终止，或者终止于沿线圈807的多个点，从而间隙沿线圈807具有中断。
支架400、500、600、700和800由自展式支架的常见材料制成，例如本领域已知的镍钛诺(钛镍合金(Ni/Ti))。
在替代实施方式中，支架12可以是如美国专利7,556,644中描述的支架，通过引用将该专利并入本申请中。
可利用本领域已知的程序将本发明的支架置于血管内。支架可装载于导管的近端并通过导管前进，并在期望位置释放。可选地，导管的远端可携带处于压缩状态的支架并将其释放在期望位置。支架可以是自展式的或通过诸如导管的可膨胀球囊段扩张。在支架被置于期望的管内位置之后，导管被撤去。
本发明的支架可置于身体管腔内(例如任意哺乳动物包括人的脉管壁血管或输送管)，而不损伤管腔壁。例如，支架可置于病变处或动脉瘤处以治疗动脉瘤。在一种实施方式中，柔性支架在插入血管后被置于大的股动脉中。在治疗病变血管或输送管的方法中，导管被引入病变血管或输送管的目标位置。支架通过导管前进到目标位置。例如，血管可以是脉管壁血管、股髂动脉、胫动脉、颈内动脉、髂动脉、肾动脉、冠状动脉、血管神经动脉或静脉。
本发明的支架可良好地适于治疗人体内经历显著生物机械力的血管。植入人体内经历显著生物机械力的血管中的支架必须通过严格的疲劳测试以合法地在市场上出售。这些测试通常模拟多次循环地装载在人体内(等于使用10年)。根据模拟的装载条件，测试循环的次数可以是100万到4亿次之间。例如，拟用于股髂动脉的支架可能需要通过弯曲测试，其中，支架被弯曲到半径大约为20mm一百万到一千万次，或者轴向压缩大约10％一百万到一千万次。
应该理解的是，上述实施方式是示例性的，仅示出了众多能够表示本发明原理的应用的可能的具体实施方式中的一部分。本领域技术人员可根据这些原理轻易地设计很多不同的其他布置，而不脱离本发明的精神和范围。例如，支架可仅由右旋或左旋螺旋部分制成，或者螺旋支撑带可在卷绕方向具有多次变化，而不是一次变化。同样地，螺旋支撑带每单位长度可具有任意数量的圈或可变间距，螺旋支撑带和/或线圈带沿支架的长度可以不一样。
本发明的支架递送系统可与任意在部分展开后允许取回的支架一起使用。

Claims (20)

1.一种自展式支架的递送系统，其特征在于，该系统包括：
内部元件，所述内部元件包括远端、近端、远端尖端和推动器，所述远端尖端位于所述内部元件的远端处，所述推动器位于所述内部元件的近端处，以及所述远端尖端具有远端和近端；
与内部元件同轴布置的外部元件，所述外部元件包括远端和近端；
滑块，位于与所述内部元件同轴的位置处，该滑块位于所述支架的内径内并与内径接触；和
远端止挡块，其附加到所述内部元件，包括近端和远端，所述远端位于所述滑块的远端和所述远端尖端的近端之间；
其中，在支架展开前，所述远端止挡块的远端邻近所述支架的远端，并且所述支架被约束在所述外部元件的内径内，所述滑块由所述推动器和在所述滑块和所述远端止挡块之间的具有一长度的第一空间支承，并且在支架展开期间，所述滑块可绕所述内部元件旋转并沿所述第一空间的长度纵向移动，使得当所述外部元件收缩以展开所述支架时，所述支架向远端移动或在所述外部元件内旋转。
2.如权利要求1所述的系统，其中，所述推动器提供近端止挡块。
3.如权利要求1所述的系统，其中，所述外部元件是外部鞘。
4.如权利要求1所述的系统，其中，所述内部元件是导线管。
5.如权利要求4所述的系统，其中，所述导线管是中空的。
6.如权利要求1所述的系统，其中，所述内部元件是固体轴。
7.如权利要求1所述的系统，其中，所述滑块通过所述支架的内壁形成到所述支架的内径。
8.如权利要求1所述的系统，还包括：
偏移元件，连接到所述推动器的远端，
其中，所述偏移元件使递送系统内的所述支架的轴向移动偏移，并在所述支架的展开期间，向远端推动所述支架的近端。
9.如权利要求1所述的系统，其中所述自展式支架包括：
螺旋支撑带，其螺旋地绕着所述支架的轴卷绕，所述螺旋支撑带包括支撑元件的波浪形状，所述波浪形状在所述波浪形状的每一侧均具有多个波峰；及
多个线圈元件，其螺旋地绕着所述支架的轴卷绕，所述线圈元件沿与所述螺旋支撑带相同的方向前进，所述螺旋支撑带使第一卷绕的至少一些所述波峰通过或在所述螺旋支撑带的第二卷绕的至少一些所述波峰附近互连，
其中，构建有几何关系三角，该几何关系三角具有：第一边，其边长LC是所述螺旋支撑带的第一卷绕和第二卷绕的互连波峰之间的所述线圈元件的有效长度；第二边，其边长是通过所述线圈元件互连的第一卷绕的波峰和第二卷绕的波峰之间的周向距离除以所述支架的纵轴和所述螺旋支撑带所成的角As的正弦值；第三边，其边长是所述螺旋支撑带在一周卷绕中前进的纵向距离（Pl）减去有效支撑长度LS；第一边的第一角，其是180度减去所述角As；第二边的第二角，其是所述纵轴与所述线圈所成的角Ac；以及第三边的第三角，其是所述角As减去所述角Ac，
其中，线圈-支撑比率是第一边长LC与长度LS的比率再乘以形成螺旋支撑带的支撑元件的波浪形状的数量NS，NS大于或等于1。
10.如权利要求9所述的系统，其中，所述线圈-支撑比率大于2.0。
11.如权利要求9所述的系统，其中，所述螺旋支撑带包括：
支撑元件的多个所述波浪形状，其中，每个波浪形状的支撑元件彼此相连。
12.如权利要求11所述的系统，包括两个所述波浪形状。
13.如权利要求11所述的系统，包括三个所述波浪形状。
14.如权利要求10所述的系统，还包括：
连接到所述螺旋支撑带一端的支撑部，该支撑部绕所述支架的所述轴卷绕，并包括多个支撑元件，所述支撑部以锐角绕所述支架的所述轴卷绕，该锐角形成在垂直于所述支架的所述轴的平面和卷绕的所述支撑部之间，该锐角小于形成在垂直于所述支架的所述轴的平面和所述螺旋支撑带的卷绕之间的锐角；及
过渡螺旋部，其互连在所述支撑部和所述螺旋支撑带的邻近所述支撑部的卷绕之间，所述过渡螺旋带包括过渡螺旋元件，所述过渡螺旋元件连接所述螺旋支撑带的邻近所述支撑部的卷绕的至少一些所述线圈元件和所述支撑部的至少一些所述支撑元件。
15.如权利要求14所述的系统，其中，随着所述支撑部的卷绕远离所述螺旋支撑带前进，相邻的所述过渡螺旋元件逐渐地绕所述支架的周长延伸较短的长度。
16.如权利要求14所述的系统，其中，所述螺旋支撑带的一些所述线圈元件不连接到所述支撑部。
17.如权利要求10所述的系统，其中，边部对中的每个边部具有相等的长度。
18.如权利要求14所述的系统，其中，所述线圈元件在其每一端包括弯曲的过渡部，所述弯曲的过渡部连接到所述螺旋支撑元件所述波峰。
19.如权利要求10所述的系统，其中，所述线圈元件包括一对由间隙分隔的线圈部分。
20.如权利要求1所述的系统，其中，自展式支架包括：
螺旋支撑带，其螺旋地绕着所述支架的轴卷绕，所述螺旋支撑带包括支撑元件的波浪形状，所述波浪形状在所述波浪形状的每一侧均具有多个波峰；及
多个线圈元件，其螺旋地绕着所述支架的轴卷绕，所述线圈元件沿与所述螺旋支撑带相同的方向前进，所述螺旋支撑带使第一卷绕的至少一些所述波峰通过或在所述螺旋支撑带的第二卷绕的至少一些所述波峰附近互连，
其中，构建有几何关系三角，该几何关系三角具有：第一边，其边长LC是所述螺旋支撑带的第一卷绕和第二卷绕的互连波峰之间的所述线圈元件的有效长度；第二边，其边长是通过所述线圈元件互连的第一卷绕的波峰和第二卷绕的波峰之间的周向距离除以所述支架的纵轴和所述螺旋支撑元件所成的角As的正弦值；第三边，其边长是所述螺旋支撑带在一周卷绕中前进的纵向距离（Pl）减去有效支撑长度LS；第一边的第一角，其是180度减去所述角As；第二边的第二角，其是所述纵轴与所述线圈所成的角Ac；以及第三边的第三角，其是所述角As减去所述角Ac。
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