CN1207657A - 可扩张的扩展装置 - Google Patents

可扩张的扩展装置 Download PDF

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CN1207657A
CN1207657A CN96196990A CN96196990A CN1207657A CN 1207657 A CN1207657 A CN 1207657A CN 96196990 A CN96196990 A CN 96196990A CN 96196990 A CN96196990 A CN 96196990A CN 1207657 A CN1207657 A CN 1207657A
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CN1208101C (zh
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M·J·李
K·H·克雷维
C·马斯特兰格罗
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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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    • 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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    • A61F2/915—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
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Abstract

一扩展装置,有一管状主体,有由多杆链系相互连接的纵长撑杆。撑杆阻止主体的缩短而且链系中的连接之间的相对转动允许径向扩张。链节在扩张时呈塑性变形以保持扩张后的直径。

Description

可扩张的扩展装置
可扩张的扩展装置被广泛地使用于为人体内的载液脉管提供局部的加固作用。扩展装置本质上是一圆筒形元件，它可沿着径向被扩张从而使脉管扩大而且支持着脉管壁以使其保持在被扩大的状态。
为了把扩展装置插入，已有人提议把扩展装置放置于一可扩张或气球状的导管上再插入。一旦扩展装置已定位于妥当的位置上，导管张大，使得扩展装置顶着脉管壁呈径向扩张。一旦扩展装置扩张到预期的直径，导管缩小并被拆除，而扩展装置则保持在位。
扩展装置理所当然应该保持顶着脉管壁呈扩张状态，而且应能够承受脉管壁所施加的力。而且，扩展装置在置入时应能通过紧贴的转弯处同时把对动脉壁的损伤减到最小程度。
已经有人提议许多不同的用于扩张扩展装置的机构，这些机构包括这样的一些装置，它们使组成扩展装置的元件重新取向以使其具有一更大的整体直径。
在另一种类别的扩展装置，典型地如Palmaz的USP4,733,665中所示的扩展装置，之中，扩展装置被构造成可以塑性变形，这样它在扩张之后即可保持其增加了的直径。在Palmaz的扩展装置中，塑性变形是由一打开-啮合的钻石形结构所提供的。当导管张大时，网状物的交叉件变形从而使扩展装置具有一增大了的直径。
在Palmaz的扩展装置中所示的设计和类似的构造中，扩展装置的径向扩张将伴随着扩展装置轴向的缩短。缩短的程度是可预测的，但扩展装置在脉管中的确切定位则无法预测。因此，扩展装置的一端可以相对于血管保持静止从而使另一端经受最大的轴向位移，或者可以使其中间部位保持静止而使两端逐渐缩短。扩展装置的缩短使得扩张的扩展装置的定位无法预测并导致脉管壁和扩展装置沿轴向相对运动，这种运动通常是我们所不期望的。
因此，本发明的一个目标就是提供一种扩展装置，其中上述的缺点被消除或减轻。
总体上说，本发明提供了一种扩展装置，其中许多沿着圆周分隔开的纵长撑杆是由多杆链系所连接的。链系的链节之间呈一定角度设置以使一径向力能引起相临链节之间的相对运动以允许扩展装置的径向扩大。纵长撑杆阻止了扩展装置的缩短从而使扩展装置的最终定位可被预测。
以下参照附图示例描述本发明的实施例，其中：
图1是一组装后的扩展装置的侧视图；
图2是沿图1中线2-2的一个视图；
图3是图1中所示扩展装置的一个展开的视图；
图4是图1-3中所示扩展装置的一部分的尺寸放大的视图；
图5是图4中所示的扩展装置的那一部分在径向扩张之后的视图；
图6是一与图4类似的视图，示明扩展装置的替代实施例；
图7是图6中实施例在径向扩张之后的视图；
图8是图4所示扩展装置的一个进一步的替代实施例；
图9是图8中实施例在径向扩张之后的视图；
图10是图4,6,8中所示的扩展装置实施例之间的比较曲线；
图11是扩展装置一进一步的实施例的透视图；
图12是图11中所示的扩展装置实施例的一个展开的视图。
图13是图11所示的扩展装置实施例的一部分的放大视图；
图14与图9类似，示明扩展装置在径向扩张之后的情形；
图15是一扩展装置支架和导管的截面网；以及
图16与图12类似，是一进一步实施例的展开的视图。
因此参照图1，一扩展装置10有一大致呈管状的主体12，它的尺寸在开始时即被设定成可以插入脉管如动脉管之中。主体12包括许多纵长撑杆14，撑杆14之间由多杆链系16相连接。链系16沿着撑杆14的轴向长度有规律地分隔开来并使撑杆14在圆周上保持着一定的间隔。
如图4所最佳示明，每一链系16包括一对导向相反的圆周链节18并有轴向链节20连接到圆周链节18上，轴向链节20平行撑杆14延伸但与其分隔开来。轴向链节20被连接到一L-型拐角链节22上，后者有一轴向脚部24及圆周脚部26。相对的拐角链节22的脚部26之间由圆周连接链节28相连接以便把相临的撑杆14连接在一起。链系16的链节18,20,22以及28是通过把一无缝管件的材料除去而形成的，上述无缝管件由生物可兼容的材料制成。这样链节之间就呈一体相互连接了。典型地这种材料可以是一种如下的金属，如：纯钛及钛合金，铂，镍记忆金属，金或不锈钢，而链系应采用微加工技术用机器进行合适的加工。也可使用认为适合于植入的其他材料包括具有所需特性的塑性材料。
每一链系16都是类似的，每一链系的链节之间的相对尺寸决定了在既定负载下其直径的改变量。在一典型的例子中，如图4中所示，假设连接链节28的长度是单位长度，那么如图4中字母所示的其他链节的相对尺寸如下：
    a     b     c     d     e     f     g     h     i     J     k
    1     2     1   0.625   1.125   0.125   2.125   2.0   1.375   1.125   0.125
扩展装置10典型地是通过一气球状导管60插入到脉管中的。扩展装置10如图15所示被安装到导管60之上。为了协助扩展装置10定位于导管60之上，扩展装置开始时被定位于一支架62之上，支架62有一杆状头部64及一逐渐变小的主体66。扩展装置10被紧密地接纳于主体66之中，主体66在一端有一凹槽68以定位导管60的尖端。如果导管是一种带有金属线的类型时，一孔70延伸穿过主体66以容纳该金属线。
一保护性套筒72套着主体66并被保持在头部64的一凸起部74之上。这样套筒72就保护着扩展装置10不受外力作用，而主体66则在扩展装置运送时起支持作用。
为了把扩展装置转移到导管60之上，应把套筒72除去并把主体66对准导管60。然后使扩展装置沿着轴向从主体66滑到导管60之上并弃掉支架和套筒。这样，扩展装置在转移时就得到引导而且也便利了扩展装置安置到导管之上的操作。
凹槽68在转移时协助导管60的定位和对准，当然如果有金属线的话，可把金属线导入镗孔70之中。
扩展装置10定位于主体66上时应使链节28比与其相连系的链节18更靠近凸起部74。这样当扩展装置10被转移到导管上时就保证了扩展装置10在导管60之上的定向使得链系16的连接链节28在扩展装置10插入脉管时比圆周链节18更靠前。
导管被以传统的方式插入脉管直到把它定位于狭窄处。
导管在安置于脉管之中后胀大以对扩展装置施加一径向的扩张力。
如图5所示，径向力的施加使得撑杆14之间的圆周间隔增大。撑杆14带动圆周链节18，通过塑性变形，同时在轴向链节20与圆周链节18和拐角链节22的连接处产生铰链作用。类似地，连接链节28在它与拐角链节22的连接处产生铰链作用力从而在链节之间产生铰链作用。这样当撑杆14伸展时链节22就自身转动。
因为链节20,22相对较窄，所以在它们接合到较大的链节18,22的地方产生的铰链力超过了材料的承受力，从而导致永久性变形及直径的增大。这样就建立了一对分隔开的铰链点而且轴向链节20和圆周链节28之间所属的全部转动都分布于这两个位点之间。
导管接着被缩小并移去而扩展装置10则保持在位。然而应该提及的是，在胀大时撑杆14保持着圆周链节18之间的轴向间隔从而使扩展装置的全长保持不变并且使脉管和扩展装置之间不发生轴向运动。
在对具有图4和5中构型的样品进行的测试中，在与用于扩张此类扩展装置相一致的负荷的作用下，撑杆14之间的间隔从最初的6个单位增加到8.48个单位。
图6和7示明链系16的一个替代实施例，其中类似的元件由类似的参照号表示，为清楚起见在参考号码之后再加后缀‘a’。
在图6的实施例中，圆周链节18a被做成是一对其间由一窄杆34连接的长方形结节30,32。轴向链节20a的长度减至0.5个单位值而且连接链节28也相应地减短到0.5个单位值。如图7中可见，径向负荷的施加导致位于杆34处的连接部位发生塑性变形从而允许长方形杆32的转动。连接链节28a也受到弯曲负荷的作用并且在与链节22a相连接的部位发生塑性变形。
在对具有如图6和7中所示的设计的样品进行的测试中，在受到一个与气球状导管所施加的径向力一致的径向力的作用下撑杆14的最初间隔增加到8.5个单位。
图8示明一进一步的实施例，其中类似的参照号同样被用以标示类似的元件，只是为清楚起见在号码之后加了一个后缀‘b’。在图8的实施例中，介于连接链节20b和圆周链节18b之间的连接部位尺寸逐渐缩小到尺寸F。类似地，介于连接链节28b和链节22b之间的接合部位的尺寸逐渐减小而且在两种情形中链节20b,28b的全长都是从一个单位值减少到0.5个单位值。而且发现其逐渐减小的斜度以45°为合适。
对图4,6和8中所示实施例进行测试的结果由图10中的曲线来表示。这一曲线表示了所施加的径向负荷及所获得的挠度。由图中可见，在每一实施例中最初负荷和挠度的增加都是呈比例的，随后更平的曲线部分则标示着塑性变形。因此，负荷的逐渐增加标示着链节的取向逐渐接近一线性取向。由图可见图8中的实施例只需较小负荷即可达到所需挠度。通过设置相对较窄的链节就可能控制用于扩张扩展装置所需的径向力以及弯曲位置。实现径向扩张所需的力必须是气球状导管所能提供的，而链节宽度的缩小使这得以实现。而且，较窄链节的塑性变形在扩张时保持着对较宽链节定位的控制。
图11-14中所示的进一步的实施例增强了扩展装置在插入时的柔韧性，这在把扩展装置置入一动脉系统并要通过难穿过的拐弯处时是必要的，以便把对动脉管壁的损伤减到最小。
在图11-14所示的实施例中，每一撑杆14c都是分隔开的，它可以由一系列的单元撑杆40组成，也可由一系列的连接撑杆42组成。
单元撑杆40和连接撑杆42沿着扩展装置10C的圆周方向交替设置而且在优选实施例中每一种都设置有偶数个以使连接撑杆42可呈径向相对。优选地可设置四个连接撑杆而且沿圆周相互间隔90°设置。
每一个单元撑杆40在两个链系16C之间延伸以便把它们相互连接。单元撑杆彼此被一个标示于44处的间隙分隔开来从每一链系16C仅仅连接到与其相邻的链系中的一个链系16C之上。相对地，链接撑杆42则于四个链系16C之间延伸并且接着通过一标示于46处的间隙与下一个链系撑杆16C分隔开来。
单元撑杆之间的间隙44沿着圆周方向相互对齐以形成一环状带48而间隔46则交错分布于交替的连接撑杆42之间。每一个连接撑杆42都有一个腰部50以便在一与扩展装置10C的表面相切的平面上提供一柔韧性增强的区域。腰部50与环状带48的其中之一对齐从而提供了一个位于链系16C之间并跨越环纹带48的连接。
如图11中可见，腰部50位于各自的边上并呈径向相对从而界定了一对枢轴Ⅹ-Ⅹ。由于相邻的链系撑杆42之间是交错的，在相邻的环状带48中腰部50偏离90°，所以枢轴Ⅹ-Ⅹ被设置于90°处。
这一安排赋予沿轴向分隔开来而且彼此垂直的轴的柔韧性从而允许扩展装置的区段之间进行相对的枢轴运动以便使其构型与其所要插入的脉管的构型相一致。
图13详细地示明了链系16C，它包括圆周链节18C和轴向链节20C，两者之间由结节32C连接。
圆周链节28C是通过拐角链节22C连接到轴向链节20C上的，拐角链节被做成长方形脚部24C。
应该提及的是，链节18C,20C,28C都是由具有一定半径的内圆角分别连接到撑杆134，结节32C以及拐角链节22C之上的，这样就减小了局部应力的集中。
在一优选实施例中，相对尺寸如下：
    a     b     c     d     e     f     g     h     i
  1.20   0.75   1.40   1.40   2.00   0.90   0.25   6.9   5.30
内圆角52每一个尺寸为0.125而材料的厚度介于0.0625至0.125之间。
设置成这种构型之后，沿径向施加负荷即导致如图14所示的圆周的扩张。在图14中可见，链节18C的弯曲是均一的，而且轴向链节20也已采取一圆周取向。
圆周扩张完成后，连接撑杆42防止扩展装置的缩短，因为每一环状带48有两个轴向撑杆阻止相邻链节16C之间的相对轴向运动。同时，相互之间设置成90°的相对比较柔韧的腰部50为扩展装置10C的插入提供了所需的柔韧性。
虽然图11中的实施例示明的转动轴相互呈90°，也可以通过改变带腰部的链节的相对取向来采用替代的安排形式。例如，通过把链节分隔60°角就可在沿轴向分隔开来的位置获得三个转动轴。
已经发现如下所示的链系16的相对尺寸效果良好：
例1：
    a     b     c     d     e     f     g     h     i
    10     7.5     11   17.8   38.6   12.3     3     46   74.2
例2：
    a     b     c     d     e     f     g     h     i
  10.3   7.3   12.2   17.8   38.6   12.3     3   48.2   74.2
例3：
    a     b     c     d     e     f     g     h     i
  10.0   7.5   11   14.3   20.4   9.2     3     46     49
在上述的每一例子中，单位是0.001英吋，而所用材料的厚度为0.003英吋。
在例1和3中，撑杆14的宽度，即其圆周尺寸是5个单位，而相邻链系16之间的轴向间隔是12个单位。
在例2中，撑杆14的宽度是2.85个单位，而相邻链系之间的轴向间隔为3个单位。
在每一种情形中，链系都沿着圆周重复4次。扩展装置的直径在扩张之前是65个单位，通过链节20C转动45°而扩张之后，例2中的外径变为197个单位，例3则为152.3个单位。链系16之间的轴向间隔应大得足以允许拐角链节在扩展装置沿径向扩张时能进行自体转动。撑杆14的设置防止了扩展装置的缩短，从而确保链系能按要求进行转动。
图16示明一进一步的实施例，其中类似的元件由类似的参照号标示，为清楚起见在号码之后再加后缀‘d’。图16的实施例与图12和13中所示的是类似的，不同之处在于每一撑杆14d都被分割成系列的单之撑杆40d，单之撑杆40d于两个相邻链系16d之间延伸。撑杆40d沿圆周交错开来以使相邻链系间的连接方向相互交替。因此，单元链系40d在径向相对的位置相互对齐，从而在沿轴向分隔开来的位置上界定了一对相互垂直的轴以在插入时提供柔韧性。
扩展装置的尺寸当然应设置得可以适配于脉管之内并且在扩张时可与脉管壁相配合。用于插入动脉管的典型的扩展装置的直径在插入时介于1.5mm到3.5mm之间，而扩张时则可有2mm至12mm。

Claims (15)

1．一种扩展装置，有一大致呈管状的主体，有许多沿圆周方向分隔开来的纵长撑杆，这些撑杆与上述主体的一个纵长轴平行地延伸，沿着圆周方向相邻的每一对上述撑杆是由许多链系所连接的，上述链系沿轴向彼此分隔开来而且每一链系包括许多相互连接的链节，上述链系的相邻链节相互之间呈一定角度设置，这样一径向力将导致相邻链节之间相对转动并进行塑性变形以使得上述扩展装置进行轴向扩张，上述撑杆防止上述链系之间的相对轴向运动以及上述主体的缩短。
2．根据权利要求1的扩展装置，其中每一上述链系包括一对沿圆周延伸的链节和一对轴向链节，轴向链节的一端连接到各自对应的上述沿圆周延伸的链节之上，上述轴向链节的两端由一圆周链节相互连接起来，上述圆周链节沿轴向与上述沿圆周延伸的链节是分隔开的。
3．根据权利要求2的扩展装置，其中上述轴向链节及上述圆周链节在其相互连接处被扩大以在每一连接处提供一对分隔开的铰链。
4．根据权利要求2的扩展装置，其中上述轴向链节在其与上述沿圆周方向延伸的链节相互连接处被扩大。
5．根据权利要求4的扩展装置，其中每一上述沿着圆周方向延伸的链节和上述轴向链节在其相互连接处都是扩大的以在每一连接处提供一对分隔开的铰链。
6．根据权利要求5的扩展装置，其中上述轴向链节和上述圆周链节在其相互连接处都是扩大的以在每一连接处提供一对分隔开的铰链。
7．根据权利要求1的扩展装置，其中每一上述撑杆在至少两个轴向相邻的链系之间延伸。
8．根据权利要求7的扩展装置，其中上述撑杆的一些被有选择地沿着上述主体周期性地中断以便在轴向相邻的链系对之间提供一间隙，上述间隙的轴向位置沿着上述主体的圆周交错开来，这样上述链系之间的相对轴向运动由一撑杆所阻止，上述撑杆沿着圆周与上述间隙分隔开来并且与上述间隙沿轴向对齐。
10．根据权利要求9的扩展装置，其中具有缩小部分的撑杆沿径向对齐以便为上述相邻链系之间的相对枢轴运动提供一条轴线。
11．根据权利要求10的扩展装置，其中在沿轴向分隔开来的位置上设置许多间隙且在每一位置上具有缩小部分的撑杆沿径向对齐以界定
12．根据权利要求11的扩展装置，其中上述枢轴轴线相互之间呈一定角度设置。
13．根据权利要求12的扩展装置，其中上述轴线相互之间呈90°。
14．根据权利要求1的扩展装置，其中上述链系是相互垂直的。
15．根据权利要求10的扩展装置，其中上述链系在其相互交叉的部位是扩大的。
16．根据权利要求15的扩展装置，其中上述链系的扩大部分通常是长方形的。
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