CN1287478A - 具有非均匀结构的扩张装置 - Google Patents

具有非均匀结构的扩张装置 Download PDF

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CN1287478A
CN1287478A CN99802014A CN99802014A CN1287478A CN 1287478 A CN1287478 A CN 1287478A CN 99802014 A CN99802014 A CN 99802014A CN 99802014 A CN99802014 A CN 99802014A CN 1287478 A CN1287478 A CN 1287478A
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extension fixture
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along
described structure
vicissitudinous
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拉奥·K·T·文卡特斯瓦拉
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Cardiovascular Systems Inc
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Cardiovascular Systems Inc
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Abstract

一种用于非均匀展开地方(例如,圆锥形或分叉动脉,或口部区域)的扩张装置。该扩张装置具有非均匀一致的结构,可以适应需要支承的具体的有病区域所固有的非均匀性特点。该结构的非均匀性包括其扩张比,径向强度、有效区域和纵向挠性上有差别。

Description

具有非均匀结构的扩张装置
背景技术
一般来说，本发明涉及一种脉管内用的扩张装置；更具体地说，涉及一种在非均匀的脉管(例如，有锥度的动脉)内，或在动脉的口或分叉处，治疗脉管疾病的专门的扩张装置。
通常，将扩张装置或可膨胀的移植物插入各种体腔中，以保持这些体腔的开放。一般，这些装置是利用导管插入体腔内，导管插在容易触及的位置上，然后再前进至展开位置。开始，该扩张装置是保持在径向压缩或折叠状态下，以便能通过体腔。一旦该扩张装置到达规定位置，则该扩张装置展开。根据扩张装置结构的不同，其展开动作可以是通过例如除去约束装置而自动实现；或是通过使该扩张装置安装在上述导管上的一个气球的膨胀而实现。
目前使用的用于脉管内的扩张装置，都设计成可在有病的脉管内膨胀，或被膨胀至一个给定的名义直径。该名义直径沿着该扩张装置的全长是固定不变的。一般，这种扩张装置在其径向强度，纵向挠性和有效区域(即：相对于被扩张装置覆盖的脉管面积而言形成展开的扩张装置表面的扩张装置材料的实际面积)方面，沿着其全长是均匀一致的。然而，大多数血管的直径不是固定不变的，有一定的自然锥度或变窄，特别是在分叉处附近更是这样。血管可以在很短的长度(小于20mm)上形成变化较大的锥度(例如颈动脉)；或者在较长的长度上(大于20mm)逐渐形成锥度(例如，肠动脉)。人体循环系统的分叉处的例子包括内、外侧颈动脉从总颈动脉分支出来的脉管轮廓。总颈动脉的直径为7～9mm，而内侧颈动脉的直径为4～6mm。在连接处有病的情况下，在该处展开的扩张装置必需在大约20～30mm的长度上，能有3～5mm的直径变化，另一个例子是扩张肾动脉。为了覆盖整个口部区域，该扩张装置必需与肾动脉的内部一致，并进入大得多的主动脉。另外，在肾动脉口上出现的损伤一般较硬和被钙化，因此要求该扩张装置在这个特殊区域具有较高的强度。在治疗天生的冠状动脉分叉处，或旁通移植物处的口部疾病，和周围(例如，颈、肾和肠)动脉的主动脉口部病时，也有同样的要求。由于在患病处血管的弯曲或扭曲形状，也可能出现血管直径非均匀。
将通常形状的扩张装置(即形状和直径均匀一致的扩张装置)放入这种地方，会产生许多问题。当将这种扩张装置放入动脉的锥度部分中时，该动脉会变成不自然的形状，或者该扩张装置在展开过程中被扭曲。当动脉变成不自然的形状时，动脉组织的某些部分会过分伸长，而其他部分则可能失去支承。使结构均匀的扩展装置作非均匀一致的扩展，会赋予该扩张装置不希望的非均匀特性(例如，径向强度，挠性和有效区域不一致)。使用结构均匀的扩张装置的另一个潜在的副作用是，该扩张装置在脉管的扭曲部分展开会使这些部分拉直，这是不希望的。
因此，需要有一种能均匀地支承非均匀的脉管，并且其有效区域、径向强度和纵向挠性沿着其全长都是一致的扩张装置。另外，还需要一种在沿着其长度的一定位置处，其有效区域、径向强度和纵向挠性可提供特定的变化，以适应沿着特定脉管的长度的脉管直径变化需要的扩张装置。
本发明概述
本发明的扩张装置的结构，可在非均匀形状的展开点(例如，有锥度或分叉的脉管)得到均匀的有效区域，一致的径向强度和/或一致的纵向挠性。另外，这种扩张装置的结构还可适应沿着该扩张装置在特定位置上，要求挠性、径向强度或有效区域有一定变化的特定点的非均匀一致的要求。
扩张装置的功能的变化可通过以预先选择的方式变化的结构来实现。依靠尺寸或几何形状的变化，或尺寸与几何形状二者的变化，赋予特定的扩张装置所需的功能特性变化。这种结构的变化可以是逐渐的或突然发生的，并且沿着该扩张装置的长度，可以包括几种不同形式的变化。
用于在有锥度的脉管中展开的本发明的扩张装置，其扩张比沿着其长度是逐渐增大的。这种变化是利用轴向对准的圆环组件达到的，该组件中的每一个圆环都为蛇形结构，并且其中，每一个重复的蛇形图案形成一个单元。通过将各个顺序排列的圆环中的单元尺寸依次地逐渐加宽，可得到用于扩张的数量增加的材料。在扩张时，这种扩张装置成为截锥的圆锥形状，可与锥形的动脉形状匹配。尽管是锥形，但该扩张装置仍可以均匀地覆盖圆锥形脉管的壁面，并且沿着该扩张装置的全长，其径向强度和纵向挠性也是均匀一致的。另外，该扩张装置的结构可使它扩张成各种不同形状或轮廓中的任何一种形状或轮廓，以适应具体的应用场合。可以利用构成上述单元的几何形状或尺寸的变化，以及几何形状和尺寸二者的变化，来改变该扩张装置的功能。
作为另一种选择方案，本发明的扩张装置结构可以是非均匀一致的，以便沿着其全长，得到一致的直径，同时使其有效区域、径向强度或纵向挠性可沿着该扩张装置的长度作预先选择的变化。这点可通过(例如)改变上述蛇形元件的厚度，而保持每一个蛇形元件的宽度固定不变；或通过改变在某些蛇形元件中的组成单元的数目来达到。通过同时改变上述单个单元的尺寸(即单元的支杆宽度和/或厚度)或几何形状；或同时改变单个单元的尺寸和几何形状二者，也可以得到同样的结果。
本发明的这些和另外一些特点与优点，通过下面结合附图，利用说明本发明原理的例子对一个优选实施例进行的详细说明，将会清楚。
附图的简要说明
图1为表示在展开前状态下的、在纵向切断和压平的本发明的扩张装置的大大放大了的平面图；
图2为在展开前状态下的图1所示的扩张装置的透视图；
图3为表示在展开状态下的，图1所示的在纵向切断和压平的扩张装置的大大放大了的平面图；
图4为在展开状态下的，图3所示的扩张装置的透视图。
优选实施例的详细描述
本发明的扩张装置的结构是为特定的展开位置专门设计的，从而克服了将一个均匀一致的扩张装置放入一个非均匀一致的地方所固有的缺点。某个位置的非均匀性可以包括：锥度、分叉、口子或任何其他在尺寸或支承要求方面的变化。该扩张装置可利用传统的方法(例如，利用在折叠状态时其周围所带的导管)放置到位。当放置到位后，可以利用一个或多个气球的膨胀，使该扩张装置扩张；或者，在该扩张装置为自行扩张式的情况下，可除去限制外套，使该扩张装置自动扩张。接着，将该导管和相应的展开装置拔出，使该扩张装置留在原处，以保持脉管开放。
通过在锥形的动脉内设置用于展开的有锥度的扩张装置，可以沿着该扩张装置的全长，得到均匀一致的有效区域，一致的径向强度和一致的刚度。另外，本发明的扩张装置的通用性，可使得该非均匀一致的扩张装置，在预先选择的位置上的有效区域、强度或刚度提高，从而可使有病的脉管口得到必要的支承。
图1表示具有本发明特点的扩张装置12，更具体地说，表示了可在锥形动脉中展开的一种扩张装置。一般，该扩张装置总的形状为管子形，但为了清楚地表示其结构，图中表示了该扩张装置在纵向切断和压平的状态。该扩张装置的结构一般包括一系列在圆周方向延伸的蛇形元件14，16，…30，这些蛇形元件由在相邻的蛇形元件之间延伸的连接件32互相连接起来。每一个这种蛇形元件的特点是，它由许多单个的单元34构成，每一个单元又包括与二个相邻的U形或V形肋条36、38连接的连接件32。在图示的实施例中，每一个蛇形元件由总共4个上述的单元组成。相邻的蛇形元件布置成使相应的一系列顶点都是相位相同的，并且在纵向方向互相对准。所有上述的连接件都从该蛇形元件的同一侧开始延伸。在所示的实施例中，所有的上述连接件都在单个蛇形元件的左边缘之间延伸。
在图1所示的实施例中，每一个蛇形元件相对于相邻的蛇形元件在蛇形图案的宽度上是变化的，即：每一个肋条的长度以及每一个连接件的长度不相同。在所示的具体的实施例中，每一个后续的蛇形元件的宽度，都依次地比其前一个蛇形元件的宽度宽；因此，相应单元的肋条和连接件也较长。然而，每一个蛇形元件中的上述单元数目保持不变，所有肋条和连接件的厚度和宽度也不变。
图2为实际使用时，在展开前的扩张装置12的透视图。总的管状结构直径是一致的，每一个蛇形元件都在该装置的整个圆周周围延伸。每个单独的蛇形元件为一个圆环，而各个连接件32只在相邻的圆环之间延伸。扩张装置的直径应选择得足够小，使它能通过病人的脉管到达展开位置。
图3表示在展开状态下的图1和图2所示的扩张装置。为了更清楚地表示结构，图中所示的装置是纵向切断和压平的。图中可清楚地看出，该装置扩张成锥形，其中，该装置右端的较宽的蛇形元件的扩张程度比该装置左端较窄的蛇形元件的扩张程度大。该扩张装置扩张成截锥形，如图4的透视图所示。每一个U形或V形肋条36、38的角度较大，张得较开，而连接件32基本上保持静止不动并对齐。肋条的变形和扩张使该装置的直径增大，但在该扩张装置展开过程中，扩张装置的总长度基本上保持不变，因为上述连接件只是将相邻的圆环互相连接起来。这是一个扩张装置非常理想的特性，因为扩张装置长度缩短不但减小了被该装置支承的总面积，而且在展开过程中，会损伤周围组织。另外，因为有同样数目的较长的肋条，使得在直径较大的圆环处的扩张装置材料较多，因此，该扩张装置的径向强度、有效区域和刚度沿着该装置的全长完全固定不变。
虽然附图表示了本发明一个实施例的结构和展开过程中的变形情况，应当理解，可以作许多改变，以使该扩张装置适合具体应用场合的特殊要求。通过改变该扩张装置的结构或其单个组成单元的几何形状，或使该几何形状有差别，可以使扩张装置的功能相应地改变或产生差别。改变上述单个肋条的厚度或宽度，也可以使扩张装置的功能产生差别。通过沿着扩张装置的长度逐渐地，或在其长度的几个孤立位置上，改变该装置的组成单元的数目，也可以使其功能产生差别。为了达到某种特定的功能，该装置的组成单元数目，这些单元的几何形状和该单元的尺寸，都可以任何组合方式改变。
可以选择上述变量，使最终得出的扩张装置能适合具体的解剖学要求，不论该脉管是锥形的，有分叉扭转或是脉管口都能适合。除了满足具体的解剖学方面的尺寸的不一致性要求以外，还可以选择同样的变量，使所得出的扩张装置能具体地适应径向强度、纵向挠性或有效区域的差别。
本发明的扩张装置可以利用任何已知的方法制造。如技术上所周知，最好用激光切割不锈钢管，作成所希望的扩张装置形状。数字式血管造影术和先进的计算算法，是可用来制造在展开时能符合脉管的自然轮廓的结构上不同的扩张装置的有价值的工具。众所周知的化学腐蚀或电抛光方法可以用来有选择地改变这种扩张装置的壁厚。
对于利用气球膨胀来扩张的扩张装置，可以利用成形的气球来展开该扩张装置；这时可利用圆锥形的气球在圆锥形的脉管内，扩张圆锥形的扩张装置。另外，还可以用尺寸变化的多个气球来达到如大尺寸的气球的锥形截面能达到的同样效果。作为另一种选择方案，也可以利用任何技术上已公知的不同方法，将该扩张装置作成自行扩张式。自行扩张式的扩张装置的展开，可通过将形状记忆合金制成的折叠的扩张装置放在一定的温度下，使该扩张装置扩张。由弹性材料制成的扩张装置可以用力使其折叠起来，并装在一个外套内。除去外套，该扩张装置就可以自动扩张。
气球扩张式扩张装置可以用任何韧性金属和合金制造，包括：不锈钢，钽，和铂-铱合金。这些金属和合金可以是涂层或不涂层的。自行扩张的扩张装置可用诸如镍钛合金(包括镍钛诺)和铜锌合金之类的形状记忆或超弹性材料或合金制造。
虽然已经说明和表示了本发明的一种具体形式，但本领域普通技术人员知道，在不偏离本发明的精神和范围的条件下，可以作许多改进。因此，除了受所附权利要求书限制外，本发明不受其他的限制。

Claims (18)

1．一种用于支承具有非均匀一致的支承要求的脉管区域的扩张装置，该装置包括：
可提供非均匀一致的支承以适应所述非均匀一致的支承要求的有变化的结构。
2．如权利要求1所述的扩张装置，其特征在于，所述结构是有变化的，可沿着其长度扩张至不同直径，而沿着其长度使径向强度基本上保持固定不变。
3．如权利要求1所述的扩张装置，其特征在于，所述结构是有变化的，可沿其长度提供保持固定不变的有效面积。
4．如权利要求3所述的扩张装置，其特征在于，所述结构是有变化的，可以扩张成截锥形，以适应同样为圆锥形的动脉。
5．如权利要求1所述的扩张装置，其特征在于，所述结构是有变化的，可以沿着其长度扩张成固定不变的直径，而沿着其长度使径向强度呈现预先选择的变化。
6．如权利要求1所述的扩张装置，其特征在于，所述结构是有变化的，可以沿着其长度扩张成固定不变的直径，而沿着其长度使有效区域呈现预先选择的变化。
7．如权利要求1所述的扩张装置，其特征在于，所述结构由单元的组件构成，并且所述单个单元的尺寸和所述单元的数目沿着所述扩张装置的长度变化。
8．如权利要求1所述的扩张装置，其特征在于，所述结构由单元的组件构成，并且，单个单元的几何形状沿着所述扩张装置的长度变化。
9．如权利要求8所述的扩张装置，其特征在于，所述单元的尺寸也是变化的。
10．如权利要求1所述的扩张装置，其特征在于，所述结构是在管子中用激光切割空隙而形成的。
11．如权利要求1所述的扩张装置，其特征在于，所述结构由金属丝构成。
12．一种用于支承锥形的脉管区域的扩张装置，该装置包括：
可以扩张成所述锥形同时沿着其长度提供恒定支承的有变化的结构。
13．如权利要求12所述的扩张装置，其特征在于，包括可扩张圆环的组件，各圆环的宽度是依次增大的。
14．如权利要求13所述的扩张装置，其特征在于，每一个圆环包括蛇形结构。
15．如权利要求14所述的扩张装置，其特征在于，每一个所述的蛇形结构包括多个重复的单元，每一个单元包括纵向的连接件，两个可变形的、基本上为U形或V形的肋条从该连接件延伸出来。
16．如权利要求15所述的扩张装置，其特征在于，每一个单元的所述连接件和所述肋条的长度，选择成可使所述扩张装置扩张时其直径达到预先选择的尺寸。
17．如权利要求12所述的扩张装置，其特征在于，所述结构是在管子中用激光切割空隙而形成的。
18．如权利要求12所述的扩张装置，其特征在于，所述结构由金属丝构成。
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CA2312566A1 (en) 2000-05-25
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