CN1296398A - 可膨胀基本单元和腔内的斯坦特固定膜 - Google Patents

可膨胀基本单元和腔内的斯坦特固定膜 Download PDF

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CN1296398A
CN1296398A CN99804828A CN99804828A CN1296398A CN 1296398 A CN1296398 A CN 1296398A CN 99804828 A CN99804828 A CN 99804828A CN 99804828 A CN99804828 A CN 99804828A CN 1296398 A CN1296398 A CN 1296398A
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tante
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side arm
elementary cell
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L·A·丁赫
L·X·法恩
R·尤里
I·波梅兰特塞瓦
M·弗罗艾克斯
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Boston Scientific Scimed Inc
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Quanam Medical Corp
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Abstract

本发明公开了一种用于如斯坦特固定膜的医疗装置中的基本单元,以及由多个单元组合体构成的并用于治疗重新狭窄或其它血管狭窄的斯坦特固定膜。该基本单元设计和制造成可均匀径向膨胀并伴有最小轴向缩短和回弹,以及可选择性改变柔性和可膨胀性。

Description

可膨胀基本单元和腔内的斯坦特固定膜
发明的技术领域
本发明总体上涉及医疗设备，并且特别是涉及一种用于植入到一个可膨胀的内用假体装置中的，一般多被称做斯坦特固定膜(stent)的基本单元和由这种基本单元构成的移植片固定膜。
发明的背景技术
斯坦特固定膜一般是可径向膨胀的圆筒形装置，用于植入到体腔内以便使一段血管或其他解剖学腔体保持张开。已发现斯坦特固定膜对保持血管成形术后的血管开放有着特殊的用途，例如避免血管的阻塞。
一般，通过将斯坦特固定膜固定在气囊导管上，并将此导管推进病人体内所需要的部位，把斯坦特固定膜插入损伤的血管中，气囊充气使斯坦特固定膜膨胀开，然后气囊排气，取出导管，血管内处于膨胀状态的斯坦特固定膜在损伤部位向血管壁施加一个径向压力，以对抗任何使血管闭合的趋向。
虽然到目前为止已经提出了多种斯坦特固定膜，但证明还没有完全满意的。例如，斯坦特固定膜径向膨胀时沿纵向长度上的缩短一直是斯坦特固定膜现有技术存在的一个问题。这会造成如何正确地在血管内放置斯坦特固定膜存在问题。
现有斯坦特固定膜的另一个问题是有限的膨胀范围。某些斯坦特固定膜只能膨胀到某种有限程度，在一定直径范围内的斯坦特固定膜必须润滑，这样增加了制造成本，使得待治疗血管病人选择合适的斯坦特固定膜尺寸成为难点。
另一个问题是对斯坦特固定膜最终膨胀直径进行控制存在着缺陷。斯坦特固定膜的膨胀率是由特殊设计或结构以及弹性常数和用于制造斯坦特固定膜的材料的弹性模量的函数决定。许多斯坦特固定膜由于其设计和结构的原因而在膨胀后表现出回弹，使得在治疗部位难以将斯坦特固定膜牢固固定。斯坦特固定膜和血管壁之间的接触不好不仅使得血管的某些部位闭合，而且会导致更严重的并发症，包括斯坦特固定膜从所要求部位的移位。试图通过选择特大尺寸的斯坦特固定膜以补偿回弹来解决这个问题并不容易，因为不适当的选择可能会导致斯坦特固定膜向血管施加过大的压力，增加导致血管损伤的可能性，例如血管壁间或血管内膜的过度增生。
另一个问题是如何满足实际需要，即在保持斯坦特固定膜易于传送的纵向柔度的同时，斯坦特固定膜应具备使血管张开所必需的径向刚度和强度。放置斯坦特固定膜经常涉及将斯坦特固定膜-导管组合穿过弯曲的血管通道，推进其到达治疗部位。
还有一个重要的问题就是斯坦特固定膜具有用于内腔传输的一个小的轮廓，它适合于用可靠和容易操作的传送系统来放置。
发明概述
本发明的一个目的是提供一种能基本上克服现有技术缺陷的斯坦特固定膜。
本发明的另一个目的是提供一种具有可选择性改变径向刚度和纵向柔度的斯坦特固定膜。
本发明的另一个目的是提供一种在植入后不出现重大回弹的斯坦特固定膜。
本发明的进一步目的是提供一种具有上述特征而且还能在其上运载聚合体部件的斯坦特固定膜。
一方面，本发明包括一个用于适合被膨胀成与血管尺寸一致的斯坦特固定膜的基本单元。该基本单元包括：(1)一个在垂直于斯坦特固定膜膨胀方向延伸的细长连接杆；(2)与所述连接杆每个末端相连的第一侧臂和第二侧臂。为了随着斯坦特固定膜膨胀侧臂进行彼此相互离开的枢轴运动，将每个侧臂在内侧臂端与连接杆相应的末端相连接，所述第一和第二侧臂具有随着这样的枢轴运动相对于连接杆向外移动的外侧臂端，以及(3)一个可膨胀的环状部件将每对第一和第二侧臂的外侧臂端相连。该环状部件具有一随着斯坦特固定膜膨胀，相对于相应连接杆末端轴向地向内移动的轴向末端；
侧臂和环状部件被制成所需的尺寸，以便当斯坦特固定膜膨胀时，使每对第一和第二侧臂中的外侧臂端径向向外移动的距离近似地等于相应环状部件末端轴向向内移动的距离，
在该基本单元的一个实施例中，每对第一和第二侧臂通过一个肩状部件被连接到各自的环状部件上。此肩状部件可以是U形、N形或W形肩状部件。
在优选的实施例中，该基本单元的环状部件具有一个波浪状外形。
另一方面，本发明包括一种适于膨胀成与血管尺寸一致的斯坦特固定膜，包括多个如上所述的基本单元的组合件。
在一个实施例中，斯坦特固定膜包括一个第一多个基本单元组合件，它通过两个轴向相邻轴末端之间的至少一个连接部件，将其连接到一个或更多个轴向相邻的多基本单元的组合件上。每个多基本单元的组合件可包括3-500个基本单元。
该斯坦特固定膜具有一个膨胀比，作为斯坦特固定膜膨胀后的直径与膨胀前的直径之比，为1-10之间。在各种实施例中，通过改变轴向长度，作为每个多基本单元的组合件的这些基本单元中一个基本单元的轴向末端间的距离，或者通过改变每个组合件中基本单元的数目而改变膨胀比。
在本发明的另一个实施例中，斯坦特固定膜还包括运载一个聚合体斯坦特固定膜外表面，斯坦特固定膜和聚合体被设计成随着施加的力而一起膨胀。
在阅读完本发明以下的详述和附图后，对本发明目的和其它目的与特征将得到更充分的理解。
附图的简要描述图1A-1B本发明斯坦特固定膜一个实施例的正面透视图，它示出了斯坦特固定膜小直径、非膨胀时的形态(图1A)(为清楚起见，斯坦特固定膜的后部未示出)和大直径、膨胀时的形态(图1B)。图2A-2B是按照本发明不同实施例的一个基本单元结构细节的平面图。图3A-3B是图1中斯坦特固定膜的基本单元的平面图，示出了基本单元的非膨胀形态(图3A)和膨胀形态(图3B)；图4A-4B是按照本发明其它实施例的一个基本单元的平面图，连接杆被改进以增大柔性。图5A-5B是一个基本单元(图5A)和多个单元组合件(图5B)的平面图，它示出了基本单元和多个单元组合件的尺寸。图6A-6C是本发明斯坦特固定膜的平面图，说明用于轴向连接多个单元组合件的一个连接部件的各种实施例。图6D-6E示出了本发明斯坦特固定膜中用于连接基本单元和多个单元组合件的连接部件的其它实施例。以及图7A-7D示意本发明的斯坦特固定膜在血管中的引入、膨胀和就位
发明的详细描述
参照图1A，示出本发明的斯坦特固定膜或者管内支撑装置的一个实施例。同时也示出了斯坦特固定膜10在非膨胀、小直径形态下被插入一个血管中的状态。为清楚起见圆柱形斯坦特固定膜的后部未示出。斯坦特固定膜10包括由例如基本单元14等多个基本单元构成的多个单元组合件12，下面还将进一步描述之。基本单元14在图中箭头15所示的径向与基本单元16相连，连接到基本单元18，以此类推构成多个单元组合件12。在与斯坦特固定膜膨胀的径向垂直的轴向，如箭头19所示，多个单元组合件12与第二个多个单元组合件20相连接。斯坦特固定膜10用两个多个单元组合件来举例说明，每个多个单元组合件包括9个基本单元，可以理解为根据所设计的斯坦特固定膜的膨胀比和要治疗的伤口的尺寸或长度，选择包含任意数量基本单元的任意数量的多个单元组合件，下面还将进一步描述之。
斯坦特固定膜10适合于膨胀成与血管一致的尺寸。一般，斯坦特固定膜被安装在一传送导管的可膨胀部件上，例如一个气囊。导管-斯坦特固定膜组件被引入到体腔内，通过气囊充气和斯坦特固定膜的膨胀将斯坦特固定膜固定在植入部位。
图1B中示出了图1A中斯坦特固定膜的膨胀、大直径形态。斯坦特固定膜，特别是斯坦特固定膜的基本单元被制成和形成所需的尺寸，下面还将进一步描述之。所以，斯坦特固定膜径向膨胀伴有轴向方向的有限度的缩短，如沿图1B箭头19所示的斯坦特固定膜的长度方向。由图1B可见，斯坦特固定膜具有一开放的网状结构，该结构允许血液在血管壁的主要部分灌注，借此斯坦特固定膜被偏移，以促进损伤血管的复原和修复。
斯坦特固定膜基本单元的特征将通过如图2-4所示的各种基本单元的实施例来说明。首先参见图2A，它示出一个未膨胀、小直径形态的基本单元24。该基本单元包括一个细长杆26，在此也称为一个连接杆或细长连接杆，该细长杆在与斯坦特固定膜膨胀方向垂直的方向延伸。斯坦特固定膜膨胀的方向如图中箭头27所示。与连接杆的每个末端28、32相连的是一对侧臂，如图中所示的杆末端28上的侧臂对32和杆末端30上的侧臂对34，侧臂对34包括在侧臂内端36a、38a与相应的连接杆末端相连的第一侧臂36和第二侧臂38。侧臂36、38被连接到连接杆以避免互相枢轴运动，这将在下面参照图3中描述。
继续参照图2A，与连接杆对侧末端的侧臂对32的侧臂一样，侧臂36、38在外侧臂端，如36B、38B，与可膨胀环部件，如部件40相连接。侧臂对通过U形肩状部件42，44，被连接到它们的各自的环状部件上，在斯坦特固定膜基本单元膨胀期间这可保持减小变形，以抵消随着轴向末端的向轴内的移动而产生的径向膨胀，以限制斯坦特固定膜的缩短。
如上所述，斯坦特固定膜侧臂对被连接到连接杆的每个末端以便在膨胀时远离每个侧臂对中的相对的侧臂和连接杆进行枢轴运动。每个侧臂对的外侧臂端以离开连接杆向外的方向运动，并沿着具有径向和轴向分量的轨道移动。外侧臂端在轴向向外方向，即在离开连接杆的轴向方向，移动的距离近似等于环状部件末端向轴内移动的距离。本发明的特征将在下面由图3A-3B得到更充分地说明。
应当理解的是，图2A中的U形肩状部件可有各种外形结构，例如图2B所示的N形或W形。在图2B中，斯坦特固定膜70包括与伸长杆76相连的侧臂对72、74。侧臂对72的第一侧臂78和第二侧臂80通过W形肩状部件84、86，在外侧臂端78b、80b被连接到一可膨胀环状部件82上。
现在转到图3A-3B，显示了本发明基本单元的一个优选实施例。所述基本单元相应于图1A-1B所示的斯坦特固定膜基本单元。基本单元90以其小直径、不膨胀的形态显示在图3A中，它包括一个连接杆92，与连接杆每个末端相连的是一对侧臂98、100。每对侧臂包括第一侧臂和第二侧臂，如侧臂对98中的侧臂102、104，侧臂102、104在内侧臂端102a、104a处被连接到连接杆末端94以避免随斯坦特固定膜膨胀引起的彼此之间的枢轴运动。在每个侧臂对98、100的第一和第二侧臂在外侧臂端，如侧臂102、104各自的末端102b、104b上，被分别连接到一个可膨胀环状部件，如部件106上，该环状部件包括一个轴向末端，例如末端108，作为在波折线110上面(见附图)的前端部。第一和第二侧臂通过肩状部件112、114连接到环状部件上，在此实施例中的该肩状部件是U形部件。
在图3A所示实施例中，每个可膨胀环状部件的轴向末端有一个波浪形或波状结构。该波浪形结构具有几个特征，这将在下面作更充分地的描述，例如基本单元膨胀比和由这些长度改变最小的基本单元组成的斯坦特固定膜膨胀比的增加；由于环状末端未象基本单元的侧臂对那样充分地径向扩张而使基本单元径向不均衡膨胀时所导致的突发事件的减少；在放置和膨胀过程中通过更均匀的力分布使得可膨胀的环状部件上应力的减小。
现在将参照图3B对基本单元的膨胀和其结构部件的移动加以描述。图3B示出了图3A中基本单元在其膨胀、大直径时的形态，并且相同的结构元件按照前面图3A中的符号来确定。基本单元随一个所施加的外力而膨胀，例如基本单元是斯坦特固定膜的一部分，斯坦特固定膜安装在一可膨胀装置，如一个气导管的气囊上，通过气囊的充气而膨胀。响应所施加力，通过连接在细长杆每个末端的侧臂的枢轴运动实现基本单元的膨胀。在侧臂内端与连接杆末端连接点上侧臂转动，而且沿向外方向相互移开。这里的“向外”是相对于连接杆，外方向指的是离开连接杆。
当侧臂向外移动时，引起可膨胀的环状部件向内移动，此处所指的是朝向连接杆的移动，在这种情况下是指朝向连接杆的相应末端。连接杆使基本单元稳定并提供受力的稳定性。更重要的是，该中心连接杆的末端作为枢轴支点，允许基本单元的膨胀，同时中心杆避免了膨胀过程中基本单元的缩短。
用于固定膜中的基本单元必须赋予固定膜足够的柔性，使斯坦特固定膜能穿过通常弯曲的血管通道而放置在治疗部位。同时斯坦特固定膜必须有足够的径向强度以保持张开体内腔体。
本发明的基本单元提供一种既具有纵向柔性，又具有径向强度的斯坦特固定膜。本发明的基本单元提供的重要优越性是，纵向柔性易于通过基本单元部件的简单改进而变化。比如，比图3的实施例具有更大柔性的实施例见图4A-4B所示。在图4A的实施例中，基本单元120包括一个连接杆122，一对侧臂124、126与该连接杆的每个末端相连接。每对侧臂中的侧臂通过可膨胀部件130、132相连接。在这个实施例中，连接杆包括一个U形环134，此环为基本单元提供纵向柔性，该基本单元将柔性传递到由这种多个单元体构成的斯坦特固定膜。图4B的基本单元136包括具有一个S形部件138的，用于增加柔性的连接杆137。
基本单元的柔性还可以通过改变基本单元的尺寸，例如，基本单元的长度和宽度、基本单元元件的长度和宽度以及相关的尺寸而发生变化。例如参见图5A，基本单元的长度Ic按照连接杆的长度a、侧臂和环状部件的长度b而变化。一般情况下，基本单元的长度Ic是1～10mm，更优选是2～8mm，最优选是2～6mm。长度b主要由可膨胀环部件的长度决定，此处，轴向前端长度b1和长度b之比的相关尺寸是可变的，以改变基本单元的柔性。基本单元的柔性也可随连接杆的长度而变化，较短的连接杆产生具有较好柔性和易处理的基本单元。连接杆长度a的一般尺寸约在1.5～2.5mm之间，长度一般b是1.5～4mm，b1是0.50～1.25mm。
继续参见图5A，基本单元的宽度Wc随基本单元的组成材料和尺寸而变化，尤其是，基本单元由合适的生物相容性材料，如不锈钢、钛、钽、金、铂和合金以及这些材料的结合，还有记忆合金和高强度热塑聚合体。图5中c和d的大小容易随材料和材料尺寸而改变。尺寸e与侧臂对的尺寸一致，是可变化的。基本单元的总宽度W的特别尺寸是在0.40～4.0mm，一般c是在0.025～0.13mm之间，d在0.03～0.10mm之间，e在0.04～0.1mm之间。
应当理解的是在一个基本单元中，尺寸c、d、e可以是相同的，也可以是不同的。特别地，改变尺寸e以便改变基本单元的强度和刚度，尤其是当基本单元处于膨胀状态时。还要注意的是，基本单元的尺寸，特别是尺寸c和e可在一个多个单元组合体内和在单元组合体之间变化，这将在下面进行讨论。
图5B示出了连在一起的六个基本单元形成多个单元组合体，以便用于构成根据本发明的斯坦特固定膜。基本单元沿着直接相邻的环状部件末端部分被连接起来，见图中尺寸f处。需注意，f是随环状部件的尺寸和相邻单元合并和重叠的程度而变化的。斯坦特固定膜的直径ds由基本单元的宽度和所连接的基本单元的数目n决定的。斯坦特固定膜的长度由基本单元的长度1c和轴向连接的多个单元组合体的数目m决定的。这样斯坦特固定膜的直径和长度是容易改变的，以治疗任何直径的血管和任何长度的伤口。
图6A-6C是上述基本单元组成的本发明的斯坦特固定膜的平面图。在图6A中，斯坦特固定膜140由m个多个单元组合体构成，在此实施例中多个单元组合体m是4，如多个单元组合体142、144、146、148。每个多个单元组合体由n个基本单元构成，此处n是9，如基本单元142(1)-142(9)。根据以上的讨论，斯坦特固定膜未膨胀直径由每个多个单元组合体中基本单元的数目n和基本单元的尺寸决定。斯坦特固定膜的长度由基本单元的尺寸和多个单元组合体的数目m决定。
继续参见图6A。多个单元组合体142、144、146、148通过一个连接部件，如150、152、154与相邻的多个单元组合体相连接，最广泛应用的连接部件是将一个基本单元连接到另一个，将一个多个单元组合体连接到另一个多个单元组合体，以形成由本发明的基本单元构成的斯坦特固定膜的任何装置。这个连接部件可以是将要描述的各种结构，它包括一个位于两个基本单元之间(图6E)的单个熔接点或一个独特的部件(图6A-6D)。连接部件可以是与基本单元接合的一个构成部分，或它可以由相同或不同材料独立形成，固定在基本单元环状末端的前端部。与连接部件本身的结构一样，连接多个单元组合体的连接部件的数目和位置可以变化以改变斯坦特固定膜的柔性，正如下面图6B-6E的实施例将看到的一样。图6B-6E显示连接部件的另一个实施例。在图6B中，斯坦特固定膜160由三个多个单元组合体162、164、166构成，多个单元组合体用轴向相邻基本单元之间的连接部件连接起来，例如带168。连接部件是U形环，相对于图6A的实施例，增加了易处理性和柔性。
图6C示出一种斯坦特固定膜170，在此多个单元组合体172、174、176通过具有大环状结构的如连接部件178的连接部件被连接在一起。要注意的是，在图6B-6C实施例中，多个单元组合体之间连接部件的数目和位置是可变化的。
图6D-6E说明按照本发明连接部件的另外两个实施例。在这些图中，连接部件连接所示的环状部件的轴向末端，而不是整个固定膜。在图6D实施例中，连接部件180是一个连接环状部件182、184的S形部件。在图6E中，连接部件186是环状末端188、190之间一个的粗焊点。
需要注意的是，不同连接部件可用于单个斯坦特固定膜中，以改变其易处理性和刚度。例如，较好刚度的连接部件如图6E的焊点，可常常被用于在斯坦特固定膜的末端连接多个单元组合体。为了较好的易处理性和较好柔性，连接部件可用于连接斯坦特固定膜内部的多个单元组合体以保持柔性。
本发明斯坦特固定膜的一个重要性能是在保持结构完整性同时，从一小轮廓直径扩张到例如径向强度的实际尺寸的能力。还有一个重要性能是斯坦特固定膜的膨胀比，即斯坦特固定膜的膨胀直径与未膨胀直径的比率，容易随着多个单元组合体中基本单元的数目和基本单元的尺寸而改变的。正如上面的讨论所证明的一样。特别是，用于形成按照本发明斯坦特固定膜的多个单元组合体中的基本单元的数目是3～500，更优选是：3～150，最优选是3～100。斯坦特固定膜的膨胀比也可通过改变基本单元的轴向长度而改变。轴向长度作为基本单元中轴向末端之间的纵向或轴向距离，在图5A中表示为Ic。轴向长度越长，斯坦特固定膜的膨胀比越大；每个多个单元组合体中基本单元的数目越多，膨胀率就越大。
用于支持本发明制成的斯坦特固定膜典型膨胀比在1～10之间。根据上述对斯坦特固定膜的描述，要明白的是，对任意可选择性地应用-从体内最小导管到最大血管-通过基本单元数目和尺寸制作本发明的斯坦特固定膜。例如，一个用于冠状动脉系统血管中的典型的斯坦特固定膜，这里血管尺寸约2～5mm，该膜包括一具有9个基本单元的多个单元组合体，每个基本单元轴向长度是3.2mm。这种斯坦特固定膜的膨胀比约为5。除了在冠状动脉系统血管以外，还可以在下列血管中使用本发明的斯坦特固定膜：颅脑系统(1～3mm)，大动脉系统(2～5mm)，脾动脉(3～6mm)，腔静脉(3～5mm)，肾动脉(3～5mm)，颈动脉系统血管，如颈动脉(大于1.5mm)，内部和外部颈动脉(5mm)，锁骨动脉，脊椎动脉，肱动脉，髂骨静脉(1～2mm)，股静脉或动脉，动脉或静脉(3～5mm)。
本发明的另一个重要特性是在膨胀到其大直径状态后的最小弹性回弹。支持本发明所制造的斯坦特固定膜被固定在一个气导管的气囊上，通过4～12atm压力的气囊充气而膨胀到。斯坦特固定膜具有初始直径1.35mm，被膨胀到3.3～3.86mm，这取决于充气压力。当气囊排气后，测出斯坦特固定膜的最后膨胀直径并与气囊充气时所测的膨胀直径相比较。本发明的斯坦特固定膜具有大约1～1.5％的回弹率(作为斯坦特固定膜气囊充气时的直径与气囊排气时的直径之比)，市场上使用的斯坦特固定膜的回弹率由同样的方法来决定，发现具有3～7％的回弹率。
本发明的斯坦特固定膜还具有径向膨胀后轴向缩短最小的优点。在上面所述的回弹性的测试过程中，测量出斯坦特固定膜膨胀后的长度并与膨胀前的长度比较。本发明的斯坦特固定膜长度减小少于0.5％，典型是膨胀后减小约0.2～0.5％。比较中，市售的斯坦特固定膜径向膨胀后长度减小3～8％。
上述斯坦特固定膜最好由具有良好机械强度的生物相容材料制成，正如上面所列。要注意的是，斯坦特固定膜径向强度…即防止重新狭窄或保持血管开放，进而防止血管回弹和痉挛的能力--是斯坦特固定膜的构成材料、设计和结构所决定的。构成斯坦特固定膜的优选的材料包括不锈钢、铂、钽和合金。斯坦特固定膜由一扁平薄片或管状结构材料通过化学蚀刻、激光切割或电子放电加工而制成。制造本发明斯坦特固定膜的一个优选方法是通过激光切割和本技术领域公知的适当的方法和装置完成。经激光切割或加工后，斯坦特固定膜被电解抛光、退火和/或按所设计钝化。斯坦特固定膜或其一部分也可以被压平或涂上试剂以提供润滑和/或可见度。例如，斯坦特固定膜可整体或部分用防辐射材料涂覆，或者用铂或金压平以改进在荧光透视中的可见度。
在本发明的另一个实施例中，所述的斯坦特固定膜通常用作支架或构件来运送包含治疗剂的聚合体或鞘。为了随着外加力与固定膜结构一块膨胀，该聚合体最好被携带在斯坦特固定膜结构的外表面。此处参考美国专利5674242，它说明了一个可同时膨胀的金属/聚合体固定膜的实例。
由于本发明斯坦特固定膜的开放、扩张时网状结构的均匀特性，而特别适合于用作结构固定膜。携带在膨胀结构斯坦特固定膜外表面上的聚合体部件充分地被支撑，从而防止聚合体掉下来和阻塞内腔。对此实施例，通过在与聚合体相接合的结构上形成凹槽或压凹制成本发明的斯坦特固定膜。按这种方式，聚合体/金属固定膜的外轮廓没有增大。
图7A-7D说明本发明的斯坦特固定膜在体腔内的引入、膨胀和就位。可以理解本发明斯坦特固定膜适合各种应用，包括，但不限于，防止重新狭窄、控制再开放、以前被阻塞的胆囊管和支撑狭窄的管腔，例如食道、肠道、尿道。
继续参见图7A-7D，首先特别参见图7A，斯坦特固定膜180被安装在导管184的气囊部分182上，通过装配在气囊上的凸起的适当位置压迫它，斯坦特固定膜被固定在导管上。把斯坦特固定膜固定到气囊上的其它方法包括临时粘合剂或可撤回的套管，或通过在气囊上的隆起或凸缘去限制斯坦特固定膜的侧向运动。
然后，将图7A的导管-斯坦特固定膜组合通过病人的体腔推进到治疗部位，如图7B所示。一旦气囊182被安放在要植入的位置，特别是穿过像血管188内动脉粥样斑那样的损伤，用已知的方法给导管的气囊部分充气，如图7C所描述。气囊的充气造成斯坦特固定膜从图7A的小直径、非膨胀状态膨胀到大直径、膨胀状态。斯坦特固定膜径向膨胀并压住损伤部位，与血管壁接合，向血管壁施加径向压力。
然后气囊放气，从血管中取出导管，斯坦特固定膜在血管内保持其膨胀状态，如图7D所示，防止血管的重新闭合或阻塞。
以上可以理解本发明是如何满足其各种发明特点和目的的。本发明的基本单元提供一个具有伴随最小轴向短缩的可径向膨胀的结构。基本单元的膨胀比容易通过基本单元部件的尺寸的选择而被改变。任意数目的基本单元可在径向和轴向连接起来，形成一个可膨胀的结构，例如用于插入一个体腔的斯坦特固定膜。当然令人满意的是，这种基本单元将应用于其它类型医疗设备或使用径向膨胀部件的其他领域。
虽然一直按照特殊实施例描述本发明，但很显然该技术的各种变化和改进都不脱离本发明的范围。

Claims (15)

1、一种用于适合膨胀成与血管尺寸一致的斯坦特固定膜中的基本单元，包括
(1)一个在垂直于斯坦特固定膜膨胀方向延伸的细长连接杆；
(2)与所述连接杆每个末端相连的第一侧臂和第二侧臂，为了随着斯坦特固定膜膨胀彼此相互离开的枢轴运动，将每个侧臂在侧臂内端与连接杆相应的末端相连接，所述第一和第二侧臂具有随着这样的枢轴运动，相对于连接杆向外移动的外侧臂端，以及
(3)一个可膨胀的环状部件将每对第一和第二侧臂的外侧臂端相连。所述环状部件具有一随着斯坦特固定膜膨胀，相对于相应连接杆末端轴向向内移动的轴向末端；
所述侧臂和可膨胀的环状部件被制造和形成所需的尺寸，以便当斯坦特固定膜膨胀时，使每对第一和第二侧臂中的外侧臂端沿径向向外移动的距离近似地等于相应的环状部件末端轴向向内移动的距离。
2、如权利要求1所述的基本单元，其中所述每对侧臂中第一和第二侧臂通过一个肩状部件被连接到环状部件上。
3、如权利要求2所述的基本单元，其中所述肩状部件是U形、N形或W形肩状部件。
4、如权利要求1所述的基本单元，其中所述环状部件具有波浪形结构。
5、一种适于膨胀成与血管大小一致的斯坦特固定膜，包括一个多个单元组合体，每个基本单元包括：
(1)一个在垂直于斯坦特固定膜膨胀方向延伸的细长连接杆；
(2)与所述连接杆每个末端相连的第一侧臂和第二侧臂。为了随着斯坦特固定膜膨胀彼此相互离开的枢轴运动，将每个侧臂在内侧臂端与连接杆相应的末端相连接，所述第一和第二侧臂具有随着这样的枢轴运动，相对于连接杆向外移动的外侧臂端，以及
(3)一个可膨胀的环状部件将每对第一和第二侧臂的外侧臂端相连。所述环状部件具有一随着斯坦特固定膜膨胀，相对于相应连接杆末端轴向向内移动的轴向末端；
所述侧臂和环状部件被制造和形成所需的尺寸，以便当斯坦特固定膜膨胀时，使每对第一和第二侧臂中的外侧臂端径向向外移动的距离近似地等于相应环状部件末端轴向向内移动的距离。
6、如权利要求5所述的斯坦特固定膜，其中所述每对第一和第二侧臂通过一个肩状部件被连接到环状部件上。
7、如权利要求6所述的斯坦特固定膜，其中所述肩状部件是U形、N形或W形肩状部件。
8、如权利要求5所述的斯坦特固定膜，其中所述环状部件具有波浪形结构。
9、如权利要求5所述的斯坦特固定膜，其中所述多个单元组合体，通过延伸在两个轴向相邻轴末端之间的至少一个连接部件，与一个或多个轴向相邻的多个单元组合体相连。
10、如权利要求9所述的斯坦特固定膜，其中每个多个单元组合体包括3～500个基本单元。
11、如权利要求9所述的斯坦特固定膜，其中斯坦特固定膜具有一个在1～10之间的膨胀比，该系数为斯坦特固定膜膨胀后的直径与膨胀前的直径的比。
12、如权利要求11所述的斯坦特固定膜，其中膨胀比是通过每个多个基本单元的组合件的一个基本单元的轴向末端间距离的轴向长度变化而改变的。
13、如权利要求11所述的斯坦特固定膜，其中膨胀比是通过改变每个组合件中基本单元的数目而改变的。
14、如权利要求9所述的斯坦特固定膜，其中所述连接部件是一个U型环带。
15、如权利要求5所述的斯坦特固定膜，其中还包括其上运载聚合体的斯坦特固定膜外表面，所述斯坦特固定膜和聚合体斯坦特固定膜被设计成随着施加力而一起膨胀。
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