CN1158078A - 柔性可伸展的植入件固定模 - Google Patents

柔性可伸展的植入件固定模 Download PDF

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CN1158078A
CN1158078A CN95195119A CN95195119A CN1158078A CN 1158078 A CN1158078 A CN 1158078A CN 95195119 A CN95195119 A CN 95195119A CN 95195119 A CN95195119 A CN 95195119A CN 1158078 A CN1158078 A CN 1158078A
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H·M·伊斯拉
G·平奇斯克
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Abstract

本发明公开了一种用于植入活体的植入件固定模(30)。植入件固定模(30)是由具有图案形状的管构成，所述的图案形状具有沿第一与第二方向延伸的轴线的第一与第二弯曲图案(11，12)。第一弯曲图案可以形成奇数和偶数第一弯曲图案。奇数和偶数第一弯曲图案的相位相互错开180°，奇数图形出现在每两个偶数图案之间。第二弯曲图案与第一弯曲图案交绕。所述第一与第二方向可以相互正交。第二种弯曲图案也可以形成奇数与偶数图案。

Description

柔性可伸展的植入件固定模
发明领域
本发明总的涉及用于植入活体的植入件固定模。
发明背景
在本技术领域中，各种植入件固定模是公知的。用于本申请的“植入件固定模”指一种用与人体相容的材料制造的装置，其用来扩张体内的血管或腔体的其它孔口，并保持内腔的总尺寸。典型地，植入件固定模是用可充气气囊输送到体内所要求的位置处，当气囊充气时，植入件固定模伸展，由此扩张上述孔口。其它使植入件固定模扩张的机械装置也可以使用。
用线材构成的植入件固定模的领域中有代表性的专利有：授予Pinchuk的美国专利5019090；授予Tower的美国专利5161547；授予Savin等的美国专利4950227；授予Fontaine的美国专利5314472；授予Wiktor的美国专利4886062和4969458；以及授予Hillstead的美国专利4856516。由切割金属构成的植入件固定模在下列专利中公开：授予Palmaz的美国专利4733665，授予Rosenbluth的美国专利4762128，授予Palmaz与Schatz的美国专利5102417，授予Schatz的美国专利5195984以及授予Meadox的WO 91 FR 013820中。
Palmaz与Schatz的美国专利5102417中所描述的植入件固定模具有由柔性连接器连接到一起的可伸展的管形植入件。这种植入件是由多个平行于管的纵轴配置的槽形成。上述柔性连接器是螺旋状连接器。由于这种管形植入件是刚性的，因而就需要柔性连接器以便使植入件固定模通过弯曲的血管时能够弯曲。当美国专利5102417的植入件固定模在伸展时，上述管形植入件径向地伸展而最后则沿纵向收缩。但在同时，螺旋连接器会扭曲。这样的扭转运动就极有可能损害血管。
Schatz的美国专利5195984描述了一种类似的，但具有一个在管状植入件之间平行于管形植入件纵轴的，具有直连接器的植入件固定模，这种直的连接件能消除扭转运动，但它不是很强的连接件。
发明概述
因此，本发明的目的在于提供一种柔性的植入件固定模，它在伸展时沿纵向有最小的收缩。
本发明的植入件固定模是由具带图案形状的管形成，这种图案形状具有第一和第二弯曲图案形状，该图案形状具有沿第一方向和沿第二方向延伸的轴线，其中的第二弯曲图案形状与第一弯曲图案形状交绕在一起。上述第一与第二方向可以是相互正交的。
根据本发明的一种实施例，第一弯曲图案形状形成为偶数和奇数的第一弯曲图案形状。此偶数和奇数的第一弯曲图案结构相互错开180°相位，而奇数图案出现在每两个偶数图案形状之间。上述第二种弯曲图案形状也可以形成为偶数与奇数的图案形状。
此外，依据本发明的一种优选实施例，第二弯曲图案形状在每个周期有两个环，而偶数和奇数的第一弯曲图案形状则分别连接到第二弯曲图案形状的每个环的第一侧与第二侧。
再有，第二弯曲图案是由偶数与奇数的第二弯曲图案形成。在该实施例中，上述偶数与奇数的第一弯曲图案都具有环，而偶数与奇数的第二弯曲图案与所述偶数与奇数的第一弯曲图案连接，使得在每对偶数与奇数的第二弯曲图案之间留有一个完整的环。
还有，根据本发明的一个优选实施例，第一与第二弯曲图案是由扁平的金属件形成。或者，它们可以由线材切割而成。另外，它们还可以由任何与人体相容的材料嵌装或覆盖。
附图简介
下面将结合附图作出详细的说明，以便更全面的认识与理解本发明，在附图中：
图1所示是按照本发明的第一优选实施例所构制和使用的带图案的植入件固定模；
图2示出图1的植入件固定模的图案；
图3示出处于弯曲状态的图1的植入件固定模；
图4示出处于伸展形式的图1的植入件固定模；
图5A与图5B示出图1的植入件固定模的图案因伸展而发生的变化；
图6是用于植入件固定模的图案的第二个实施例的示意图；
图7是用于植入件固定模的图案的第三个实施例的示意图；以及
图8是处于伸展状态的图7的图案的示意图。
优选实施例的详述
现在参有图1至图4，它们示明了依据本发明的原理构制和工作的植入件固定模的第一个实施例。图1所示是非伸展形式下的植入件固定模，图2表明植入件固定模的图案，图3示出植入件固定模处于部分弯曲位置，图4说明植入件固定模处于伸展形式。
本发明的植入件固定模为管件，其侧面形成为多个有两种正交的弯曲图案，这两种图案相互交绕。术语“弯曲图案”在此是用来描述围绕中心线的周期性图案；“正交的弯曲图案”是一种图案其中心线相互正交。
在图1至图4的植入件固定模中，上述两种弯曲图案由11与12标明，它们在图2中极易看清。弯曲图案11是具有垂直的中心线9的垂直的正弦曲线。弯曲图案11的每个周期有两个环14和16，其中的环14向右敞开而环16则向左敞开。环14与16均分共用部件15与17，部件15从一个环14连接到下一个环16，而部件17从一个环16连接到相继的环14。
弯曲图案12为具有水平中心线13的水平图案，弯曲图案12也有环，以18与20标明，但在每个周期中的两个环之间则是由22标明的平直延伸部分22。环18开口向下，环20开口向上。垂直的弯曲图案11是以相位相互错开180°的奇数与偶数(o与e)的型式出现。这样，弯曲图案11o的每个左开口的环16面对弯曲图案11e的右开口的环14，而弯曲图案11o的右开口的环14则面对弯曲图案11e的左开口的环16。
水平弯曲图案12也是以奇数与偶数形式形成。水平弯曲图案12e的平直部分22与垂直弯曲图案11e的每第三个共用部件17相交。水平弯曲图案12o的平直部分22则与垂直弯曲图案11e的、在相交的公用部件17之后的两个共用部件15开始的每第三个共用部件15相交。最终在弯曲图案12e和12o之间是一个整环14，在弯曲图案12o与12e之间是一个整环16。
返回图1，图2中的图案形成在易变形的材料(例如金属)形成的管件30上。由于这两种弯曲的图案，因此当图1中的植入件固定模接附到导管气囊上就成为柔性的，由此，可以易于牵引通过弯曲血管。依这样方式图1中植入件固定模弯曲的例子示明于图3中。
图3中，植入件固定模在点A处依箭头40的所示方向开始弯曲。当植入件固定模开始变弯，标志为I的部分成为弯曲的内侧，而标志为O的部分成为弯曲的外侧。弯曲部分I的内侧比弯曲部分O的外侧短。
弯曲时，点A右边的环14-20改变形状，以便补偿内、外侧弯曲部分间的在长度上的差异。例如，靠近弯曲的内侧的环18i与20i就比弯曲的外侧上伸展开的环18o与20o靠得较近。靠近弯曲的内侧I的环14i与16i受压缩，而靠近此弯曲的外侧O的环14o与16o则伸展。
正如图中所示，在上述变弯过程中涉及两种弯曲图案11与12。尽管图中未予示明，但应认识到图1至图4中的植入件固定模是可以在任何时刻沿任何方向而且是多于一个方向弯曲。
图4示明图1的处于展开形式的植入件固定模。当植入件固定模展开时，两种弯曲图案11与12都展开(亦即所有的环14-20开口朝上)。从图中可以看到，展开的植入件固定模有两类封装空隙，亦即在弯曲图案12o与12e间的大空隙42和弯曲图案12e与12o间的小空隙44。如图所示，每个大空隙42在其左侧有两个环14而在其右侧有两个环14。垂直弯曲图案11e与11o之间标以42a的大空隙在其顶端与底端有环18，而在垂直弯曲图案11o与11e之间标以42b的大空隙在其顶端与底端有环20。对于小空隙44a与44b也与此类似。
应该注意到，由于有正交的弯曲图案11和12，图1的植入件固定模在伸展过程不会出现显著地收缩。为此可参看图5A与5B所示的细节。图5A表示一个垂直弯曲图案11在伸展过程中的运动，而图5B则表示一个水平弯曲图案12在伸展过程中的运动。原有的图案以实线表示，展开的图案以虚线表示。
图5A的垂直弯曲图案11通过拓宽它的环14与16而伸展。其结果是垂直弯曲图案11的每个环以2h1的量垂直地增长。但是，它也以2d1的量水平地收缩。类似地，图5B的水平弯曲图案通过拓宽它的环18与20而伸展。其结果是水平弯曲图案12的每个环以2d2的量水平地增长。但是，这也会以h2的量垂直地收缩。由此，垂直弯曲图案11的垂直增长至少是部分地补偿水平弯曲图案12的垂直收缩，反之亦然。应该注意，任何植入件固定模的两端R是部分地补偿，因而会稍有收缩。
应该认识到，两个正交的弯曲图案11与12以及它们给彼此提供的补偿能使图1中未伸展开的植入件固定模成为柔性的。但是，当植入件固定模展开时，每个环14与16的变化都会使最终的植入件固定模具有刚性，因而使它能使血管保持所需的内径。
本发明的植入件固定模可以由扁平的金属腐蚀成图2的图案制成。腐蚀后的金属然后弯成管30。或者，图2的图案可由焊结或加捻线材形成。
应该明白，本发明的植入件固定模能够由金属和/或线材制成。此外，它还可以镀上保护材料，嵌装上药物以及/或者由能填充在空隙42和44的材料包覆。
应该明白本发明概括了所有由两种正交或不正交的弯曲图案所构成的图形制造的植入件固定模。本发明还提供了另一种典型的图形，它也是由正交弯曲图案形成，其中，图6是示意图，图7是更具圆形头的示意图。图8所示的是图7中图案处于展开状态的示意图。图6与图7的图案与图2所示的类似，只是它具有更多的水平弯曲图案12，而且它们是同一类型的，而不是图2中的奇偶形式。
正如在图6与7中所示，存在着两种类型的相位上相互错开180°的垂直弯曲图案11e与11o。水平弯曲图案12与垂直弯曲图案11e的每条线15连接。
图8说明图7中图案处于展开状态，由于不存在奇、偶水平弯曲图案，所以，在图8的展开状态就设有大、小空隙。所有空隙的大小都相同。
对于本专业的技术人员应该明白，本发明并不限于上面具体的图示和说明。相反，本发明的保护范围是由后附权利要求书所界定。

Claims (14)

1.一种由具有图案形状的管形成的植入件固定模，所述的图案形状包括：
a.偶数的第一弯曲图案，其具有在第一方向延伸的轴，
b.奇数的第一弯曲图案，其具有也在第一方向延伸的轴，其中，所说的奇数的第一弯曲图案与所说的偶数的第一弯曲图案错开180°，且出现在每两个偶数的第一弯曲图案之间；
c.第二弯曲图案，其具有在不同于所述第一方向的第二方向延伸的轴线，其中，所说的第二弯曲图形与所述偶数和奇数的第一弯曲图案交绕，以便形成大致均匀分布的结构。
2.如权利要求1所述的植入件固定模，其中所述的偶数的第一弯曲图案与奇数第一弯曲图案围绕所述沿第一方向延伸的轴线作周期性分布，和其中所述的第二弯曲图案围绕所述沿第二方向延伸的轴线作周期性分布。
3.如权利要求1或2所述的植入件固定模，其中所述第二弯曲图案在每个周期具有两个环，其中奇数与偶数第一弯曲图案分别连接在每个环的第一侧与第二侧上。
4.如上述权利要求的任何一项权利要求所述的植入件固定模，其中所述第二弯曲图案由奇数与偶数第二弯曲图案形成。
5.如权利要求4所述的植入件固定模，其中所述偶数和奇数第一弯曲图案具有环，和其中所述偶数和奇数第二弯曲图案连接到所述偶数和奇数第一种弯曲图案上，以便在每对奇数和偶数第二种弯曲图案之间留下一个整环。
6.一种由具有图案形状的管形形成的植入件固定模，所述的图案形状包括：
a.具有在第一方向延伸的轴线的第一弯曲图案；
b.具有在不同于上述第一方向的第二方向延伸的轴线的第二弯曲图案，其中所述的第二弯曲图案与偶数和奇数第一种弯曲图案交绕，以便形成大致均匀分布的结构。
7.如权利要求6所述的植入件固定模，其中所述第一弯曲图案围绕在所述第一方向延伸的轴线是作周期性分布的，和其中所述第二弯曲图案围绕所述第二方向延伸的轴线作周期性的分布。
8.如权利要求1至7中任一项所述的植入件固定模，其中所述第一方向与第二方向正交。
9.如权利要求1至7中任一项所述的植入件固定模，其中所述第一方向与第二方向不正交。
10.如权利要求1至9中任一项所述的植入件固定模，其中所述第一与第二弯曲图案是由线材形成。
11.如权利要求1至9中任一项所述的植入件固定模，其中所述第一与第二弯曲图案结构是用扁平金属件切割而成。
12.如上述任一项权利要求所述的植入件固定模，其中，所述植入件固定模是依下述方式之一完成的：用保护材料镀覆、用药物嵌埋、以一种材料覆盖。
13.一种植入件固定模，它包括：
a.至少是奇数与偶数交替的盘旋段，每段具有第一弯曲区，其中所说的奇数盘旋段与偶数盘旋段在相位上错开，使得奇数盘旋段上的第一弯曲区与偶数盘旋段上第一弯曲区邻接；以及
b.至少一个柔性连接件，它包括多个柔性的连接环，其连接相邻的偶数与奇数盘旋段中相邻的第一弯曲区，
其中每个柔性连接环至少具有两个通过至少一个第二盘旋区所连接的部分，其中所述的第一与第二盘旋区界定出第一与第二角度，它们的扁平分线相互构成一定角度。
14.由多个相邻的连接单元组成的植入件固定模，每个单元包括：
偶数个定长的交替的第一与第二环连成的封装单元，每个环至少具有两个在其间有一弯曲区的部分，所述的第一与第二环界定第一与第二角度，它们的角平分线相互构成一定角度。
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PT846450E (pt) 2002-05-31
JP2005205238A (ja) 2005-08-04
CA2365589C (en) 2004-03-16
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DK0762856T3 (da) 1999-06-07
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CA2365589A1 (en) 1996-02-08
EP1602343A2 (en) 2005-12-07
DE69525182D1 (de) 2002-03-14
SE9700206L (sv) 1997-02-28
EP0846452B1 (en) 2002-01-16
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ATE286689T1 (de) 2005-01-15
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DE69525072D1 (de) 2002-02-21
PT846449E (pt) 2002-07-31
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JPH11319112A (ja) 1999-11-24
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DE29521205U1 (de) 1996-09-19
EP0846452A3 (en) 1999-11-03
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DE19549477C5 (de) 2015-02-19
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WO1996003092A1 (en) 1996-02-08
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CA2424525C (en) 2006-01-31
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FI970316A (fi) 1997-03-07
ATE211898T1 (de) 2002-02-15
EP0846448A3 (en) 1999-11-03
EP1181901B1 (en) 2005-11-09
BR9508353A (pt) 1997-11-04
ATE170733T1 (de) 1998-09-15
ATE308945T1 (de) 2005-11-15
SI9520079A (en) 1997-12-31
AU702468B2 (en) 1999-02-25
NO312122B1 (no) 2002-03-25
EP1602343A3 (en) 2008-06-18

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