CN1217216A - 多层金属扩张器 - Google Patents

多层金属扩张器 Download PDF

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CN1217216A
CN1217216A CN98119664A CN98119664A CN1217216A CN 1217216 A CN1217216 A CN 1217216A CN 98119664 A CN98119664 A CN 98119664A CN 98119664 A CN98119664 A CN 98119664A CN 1217216 A CN1217216 A CN 1217216A
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dilator
coating
tubular member
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stay
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J·里希特
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MEINOL Ltd
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Abstract

一种带涂层的扩张器,用以增加辐射不透明性。在一个实施例中,管形件形式的扩张器包括由第一材料制成的撑条和在管形件上的第一涂层。第一涂层覆盖整个管形件并有均匀的厚度。构成第一涂层的第二材料比第一材料更不透射线。在另一实施例中,扩张器还包括一个位于管形件和第一涂层之间的第二涂层,其中第二涂层仅覆盖管形件的一部分。在还一实施例中,扩张器是一个带涂层的分叉的扩张器,用以在分叉的人体腔体中定位。

Description

多层金属扩张器
本发明涉及设置在人体腔体内的扩张器，更具体说涉及使这种扩张器的辐射不透明性最佳化。
扩张器为管形结构，它被植入人体导管，血管或其它体内腔体中，以加宽和/或保持该腔体张开。一般来说，扩张器在压缩状态下被送入人体内，随后，一旦定位在腔体内的目标位置上就扩张到最终直径。扩张器常在气囊血管成形术之后使用或代替气囊血管成形术，以修复导管狭窄并防止进一步的导管再狭窄，更广泛地说，扩张器可用于修复多个管形人体导管中的任何一个，例如在血管，胆管，生殖泌尿系统，呼吸系统及其它系统中的导管。在由金属丝制成的扩张器领域中，示范性的专利例如包括授予Pichuk的美国专利5,019,090；授予Tower的5,161,547；授予Savin等的4,950,227；授予Fontaine的5,314,472；授予Wiktor的4,886,062和4,969,458；和授予Hillstead的4,856,516；它们均结合于此作为参考。由切割块状金属制成的扩张器例如描述于授予Palmaz的美国专利4,733,665；授予Rosenblnth的4,762,128；授予Palmaz和Schatz的5,102,417；授予Schatz的5,195,984；授予Meadox的WO91FR013820；和授予Medinol的WO9603092，它们均结合于此作为参考。分叉的扩张器描述于授予MacGregor的美国专利4,994,071，和1996年5月3日递交的共同转让的美国专利申请系列号08/642,297，它们均结合于此作为参考。
为使扩张器起作用，重要的是使它们在人体腔体内的目标位置准确地定位。当例如需要多处扩张(有搭接的多个扩张器以覆盖过长区域或分叉的血管)时尤为如此。在这些和其它情况中，在置于人体内期间和扩张器扩张后常需要能目视观察扩张器。为获得这种目视效果，已作了许多努力。例如，扩张器由射线透不过的(即不允许X射线，伽玛射线或其它形式的辐射能量通过)金属制成，例如钽和铂，以便于X线透视检查。但这种扩张器的其中一个潜在问题是：即便不是不可能，但也难以在辐射不透明性和扩张器强度之间达到有利的平衡。例如，为了制造这样一种具有足够强度的扩张器，常需增加扩张器的尺寸，这样使扩张器变得过分地不透射线。结果，在植入后这种扩张管的X线透视就可能遮蔽所植入血管的血管照相的细节，例如组织脱垂和增生。
用以获得扩张器目视效果的另一项技术是在预定位置对扩张器使用射线透不过的标记。但扩张器和标记材料(例如分别是不锈钢和金)的连接可能在血液中产生连接点势能或紊流，并因此促使血栓形成，例如血凝块。因此，就尽可能减小标记的尺寸以避免这一问题，其不利效果是大为减小了的X线透视检查的可视性，并使这种可视性对透视方向很敏感。
用以获得扩张器可见效果的另一技术是简单地增加这种扩张器的厚度，以增加其辐射不透明性。但是过厚的扩张器撑条对血液的流动会有效地产生一种阻碍。此外，对具有较厚撑条的扩张器的设计极限值常导致这些撑条之间的较大缝隙，这样就降低了对周围腔体的支承力。而且，过厚的扩张器撑条会有害地影响扩张器的柔性。
这样，就需要辐射不透明性增加的扩张器，但这种扩张器的机械性质或性能不会受到损害。带有不透射线的材料的扩张器涂层描述于授予Fishell等的美国专利5,607,442中。根据该专利，与径向的扩张器部件相比，在纵向的扩张器部件上所公开的不透射线的涂层要厚的多，这样在X线透视期间只能见到纵向的扩张器部件。
本发明的目的是提供一种具有最佳的辐射不透明性和机械性能的扩张器。
在一个实施例中，本发明包括一个由管形件构成的扩张器，该管形件由撑条和在管形件上的第一涂层构成，撑条由第一材料制成。第一涂层大致覆盖管形件并在厚度上是大致均匀的。第一涂层由第二材料构成，第二材料比构成撑条的第一材料更加不透射线。
在本发明的另一实施例中，扩张器还包括一个位于管形件和第一涂层之间的第二涂层，其中第二涂层仅覆盖管形件的一部分。当用X线透视观察扩张器时，存在第二涂层的部分比仅存在第一涂层的部分要暗。
在本发明的另一实施例中，扩张器是一带涂层的分叉的扩张器，用以定位在分叉为一个主腔体和一个分支腔体的人体腔体中。扩张器具有一干路和分路，用以分别定位在主腔体和分支腔体中。在该实施例中，扩张器上涂敷有多层射线透不过的材料，这样当用X线透视观察扩张器时，分路比干路要暗。
图1A示出了根据本发明的一个实施例的带涂层并制有花纹的扩张器。
图1B是一横截面图，示出了图1A所示扩张器的一典型撑条。
图2A示出了根据本发明一个实施例的优选的扩张器构形。
图2B示出了根据本发明一个实施例的扩张器单独一个部分的最优选构形。
图3A示出了根据本发明一个实施例的制有花纹的扩张器，其上具有多层涂层。
图3B是一横截面图，示出了图3A所示扩张器的一个典型撑条，在此位置对扩张器涂敷有两个涂层。
图3C是一横截面图，示出了图3A所示扩张器的一个典型撑条，在此位置对扩张器涂敷有一个涂层。
图4A示出了根据本发明的一个实施例的带涂层的分叉的第一个扩张器。
图4B-4C示出了根据本发明一个实施例的带涂层的分叉的第二个扩张器。
本发明提供了一种具有最佳辐射不透明性的扩张器，而不会牺牲其机械特性或性能。根据本发明的扩张器是由一种具有所需机械特性(如强度)的基体材料制成，并涂覆一种材料以使扩张器具有最佳的辐射不透明性。在这种意义上而言使本发明的扩张器的辐射不透明性达到最佳，即在X线透视程序期间，整个扩张器是可见的，但不是如此的辐射不透明以致遮蔽血管照相的细节。这样，本发明提供了这样一种扩张器，它具有基体材料的理想机械特性同时也具有涂覆材料的理想辐射不透明性。本发明的扩张器所具有的附加优点是可以根据简单以及可重复生产的技术进行制造。
在本发明的一个实施例中，扩张器100是一个由撑条110构成的管形件101，如图1A-1B所示。这里所用的“撑条”一词，用以指一个扩张器的任何结构性的构件，例如由线材，切割块或其它材料制成的任何径向，纵向或其它构件。撑条110由一第一材料构成，对其的选择要考虑其机械特性，例如在处于压缩状态的同时被植入体内的能力，一旦定位在目标区扩张或被扩张的能力，抵抗反冲的能力，以及在扩张器的寿命期限内使体内腔体保持敞开的能力。用于撑条110的典型示范性材料包括不锈钢和镍钛诺。扩张器100还包括由第二材料构成的第一涂层102，第二材料的选择要考虑其辐射不透明性。涂层102覆盖整个管形件101，其结果是第一和第二材料的相交表面不会暴露于扩张器的外面。通过不使第一和第二材料的相交表面暴露在扩张器的外面，就可以排除在血液中产生连接点势能的危险以及使扩张器电解腐蚀的危险。图1B示出了在扩张器100的典型撑条110上的涂层102的横剖视图。层管在图1B中示出的撑条110和涂层102在横断面形状上大致呈方形，这些构件中的两者或其中之一的实际横断面形状可以是任何所需的或适当的形状，例如圆形，椭圆形，矩形或任何一组不规则形状。
可以用任何适当的技术将涂层102覆盖于管形件101上，例如电镀，无电敷镀，离子束辅助沉积，物理蒸镀，化学蒸镀，电子束蒸发，浸镀或任何适当的喷涂或蒸发工艺。涂层102包括任何适当的辐射不透明材料，例如金，铂，银和钽。
涂层102的厚度是本发明的一个重要方面。太厚的涂层会导致扩张器过度地不透射线，结果在后面的X线透视期间将遮蔽电子照相的细节。此外，扩张器的刚性常常会随涂层厚度增加，这样如果涂层太厚就会使放在体内腔体中的扩张器难以扩张。另一方面，太薄的不透射线的涂层在X线透视期间就不能是充分可见的。考虑到管形件101的材料和构形，以及涂层102的材料，使涂层102的厚度最佳化以在辐射不透明性和强度之间提供最佳的平衡。然而，一般来说，涂层102最好是下面的撑条厚度的约1-20％，更好是约5-15％。在本发明的所有实施例中，涂层102被覆盖在整个扩张器上，使之在X线透视期间整个是可见的。相应地，沿扩张器的任何位置处的次优的扩张亦可见到，并且从最佳的圆形扩张的任何偏离也可被注意。
本发明的扩张器具有任何适当的构形，尽管在1995年5月31日递交并结合在此作为参考的WO9603092和共同转让的已授权美国专利申请系列号08/457,354中所描述的带花纹构形对于本发明的所有实施例而言是优选的。作为这种构形的一个例子(图2A和2B示出了它的靠拢状态)，扩张器100是一个具有侧面的管，这些侧面被成形为相应盘绕的一组两个正交的曲折花纹。这里所用的“曲折花纹”一词是用以描述绕一中心线的周期性花纹，“正交的曲折花纹”是具有相互正交的中心线的花纹。
如图2A所示，扩张器100可选择地包括两个曲折花纹11和12。曲折花纹11是一个具有垂直中心线9的垂直正弦波。曲折花纹11每周期有两个环圈14和16，其中环圈14朝右侧开口而环圈16朝左侧开口。环圈14和16享用共同的构件15和17，其中构件15从一个环圈14连接到它的下一个环圈16，构件17从一个环圈16连接到它的下一个环圈14。曲折花纹12是一个具有水平中心线13的水平花纹。曲折花纹12也具有标为18和20的环圈，它们可以相同的或相反的方向定向。图2A所示的带有正交曲折花纹11和12的扩张器构形可以提供高度的扩张器柔性以便于扩张，同时一旦扩张器扩张又可保持高度的刚性。图2B示出了根据本发明的最优选扩张器构形的一个局部的详细视图。
在图3A-3C所示的本发明的另一实施例中，扩张器200包括一个第二涂层202，位于扩张器200的撑条110和第一涂层102之间。但与第一涂层102不同，第二涂层202仅覆盖扩张器200的一个部分或多个部分，使得在X线透视期间扩张器200的隔离的区域是最为可见的。例如，第二涂层202用于扩张器200的近端111和远端112中的一端或两者，如图3A所示。然而如同在图1A-1B中所示的实施例，第一涂层102覆盖图3A-3C所示的整个扩张器200。图3B和3C示出了扩张器100的撑条110的横截面图，其中分别施用了和未施用第二涂层202。这种隔离的标志在准确定位扩张器端部时十分有用，例如对于使用多个扩张器的情况，其中搭接的长度很重要，或者例如对于使用心门扩张器的情况，其中扩张器的端部相对于心门的位置很重要。
第二涂层202包括适当的射线透不过的材料，例如金，铂，银和钽，并可相同于或不同于第一涂层102的材料。第二涂层202可通过任何适当的技术涂覆在扩张器200上，例如针对涂覆第一涂层202所描述的这些技术。例如在涂覆第二涂层202期间通过屏蔽或在第二涂层202涂覆后通过隔离浸蚀。将第二涂层202仅涂覆在管形件101的一个部分或多个部分上。应当理解尽管涂层202在这里被描述为“第二”涂层，它也可以在涂覆第一涂层102之前涂覆到扩张器200上。
当使用时，与不存在第二涂层202的部分相比，第二涂层202的厚度会导致存在第二涂层202的部分处的辐射不透明性增加。由于第二涂层202仅被涂覆到扩张器200的一个部分或多个部分上，它可被涂敷的较厚，而不致显著影响扩张器200对扩张的抗力或在X线透视期间影响动脉细节的可视性。与第一涂层102相同，应使第二涂层202的厚度达到最佳化，以在扩张器的辐射不透明性和其它特性之间到达一理想的平衡。但一般而言，第二涂层202的厚度与第一涂层102相同或比第一涂层102厚。当涂敷第一和第二涂层102,202两者时，第一和第二涂层102,202的厚度最好分别是下面的扩张器撑条厚度的约1-5％和5-15％。而且，第一和第二涂层102,202的组合厚度一般不超过下面的扩张器撑条厚度的25％。作为一示范性例子，在一个撑条直径为100微米的扩张器上第二涂层202被涂敷到约10微米的厚度。第一涂层102然后被涂敷到约1微米的厚度。
在本发明的另一实施例中，扩张器300是一个分叉的扩张器，如图4A所示。扩张器300由一管形件301构成，管形件301分叉为管形干路和分路310,311，分别用以在一分叉腔体的主腔体和分支腔体中定位。在该实施例中，整个扩张器涂敷有针对图1和3所示实施例所描述的第一涂层102。然而，分路311包括位于管形件301和第一涂层102之间的第二涂层202，这样当用X线透视观察到扩张器300时，分路311看上去比干路310暗。这样扩张器300的干线和分路311,310的撑条的横截面形状就分别如图3C和3B所示。这种构形对于将分路311对准和插入一个分支腔体而言很有用。
作为另一种选择，分路311可被有选择地插入管形件301的分路孔312中，使得管形件301和干路310被分别送入分支腔体中。在这种情况下，管形件301带有一个分路孔312，如图4B所示。当管形件301被送到一分支腔体内时，可将分路孔312对准相应的分支腔体。然后使扩张器300的管形件301扩张以固定它在待处理的腔体中的位置，并将分路311送入分路孔312，这样部分分路311就被定位在分支腔体内。随后，如图4C所示使分路311扩张，其扩张程度足以使其外表面与管形件301限定分路孔312的部分相啮合并将分路311固定在分支腔体和管形件部分301内。在本发明的该实施例中，环绕分路孔312的区域313包括第一和第二涂层102,202，这样在X线透视期间区域312是最为可见的。换句话说，扩张器300的区域313的撑条的横截面图如图3B所示，其它部分则如图3C所示。对于将分路孔312对准一分支腔体以使分路311随后的方便地插入分支腔体而言，这样一种构形很有用。
本发明提供了具有最佳辐射不透明性的扩张器，而不会牺牲扩张器的特性或性能。本领域技术人员可对本发明的上述实施例作许多改动。这种改动由所附权利要求书的精神和范围所覆盖。

Claims (18)

1．一种用以设置在人体腔体内的扩张器，包括：
一个由撑条构成的管形件，撑条由第一材料制成，所述管形件具有一近端和一远端，以及一个纵向通孔；和
在所述管形件上的第一涂层，所述第一涂层大致覆盖所述管形件并在厚度上是大致均匀的，所述第一涂层由第二材料构成；
其中所述第二材料比所述第一材料更加不透射线。
2．如权利要求1所述的扩张器，其中所述第一涂层的厚度大约是下面的撑条的厚度的1-20％。
3．如权利要求2所述的扩张器，其中第一涂层的厚度大约是下面的撑条的厚度的5-15％。
4．如权利要求1所述的扩张器，其中所述第一涂层的厚度约为0.5-20微米。
5．如权利要求1所述的扩张器，其中所述第一材料从包括不锈钢和镍钛诺的组中选择。
6．如权利要求1所述的扩张器，其中所述第二材料从包括金，铂，银，钽的组中选择。
7．如权利要求1所述的扩张器，还包括一个位于所述管形件和所述第一涂层之间的第二涂层，所述第二涂层仅覆盖所述管形件的一部分。
8．如权利要求7所述的扩张器，其中所述第二涂层位于所述管形件的所述近端或所述远端。
9．如权利要求7所述的扩张器，其中当用X线透视观察扩张器时，所述扩张器上存在所述第二涂层的部分比不存在所述第二涂层的部分要暗。
10．如权利要求7所述的扩张器，其中所述第二涂层的厚度大约是下面的撑条的厚度的1-20％。
11．如权利要求10所述的扩张器，其中第二涂层的厚度大约是下面的撑条的厚度的5-15％。
12．如权利要求7所述的扩张器，其中所述第二涂层的厚度大约是0.5-20微米。
13．如权利要求12所述的扩张器，其中所述第二涂层的厚度大约是5-15微米。
14．如权利要求12所述的扩张器，其中所述第一涂层的厚度大约是1微米。
15．如权利要求7所述的扩张器，其中所述第二涂层由这样一种材料构成，该材料选自包括金，铂，银和钽的组。
16．如权利要求1所述的扩张器，其中所述管形件分叉为一个干路和一个分路，用以在分叉腔体的相应主腔体和分支腔体中定位。
17．如权利要求16所述的扩张器，还包括在所述管形件和所述第一涂层之间的第二涂层，所述第二涂层仅覆盖所述分路。
18．如权利要求16所述的扩张器，其中：
所述管形件包括一个分路孔；
所述分路可被有选择地设置在所述管形件内；和
所述管形件邻近所述分路孔的区域包括一个位于所述管形件和所述第一涂层之间的第二涂层。
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WO1999025272A1 (en) 1999-05-27
AU8882998A (en) 1999-06-07
CA2245805A1 (en) 1999-05-13
CA2245805C (en) 2008-01-08
JPH11226132A (ja) 1999-08-24
EE9800313A (et) 1999-06-15
ATE386476T1 (de) 2008-03-15
AU757255B2 (en) 2003-02-13
NO983878L (no) 1999-05-14
US6315794B1 (en) 2001-11-13
DE69839141D1 (de) 2008-04-03
IL125897A (en) 2001-08-08
GB9824854D0 (en) 1999-01-06
DE69839141T2 (de) 2009-02-26
EP0916317A1 (en) 1999-05-19
KR19990044811A (ko) 1999-06-25
AU8192998A (en) 1999-06-10
EP0916317B1 (en) 2008-02-20
KR100309485B1 (ko) 2002-02-19
GB2331246B (en) 2002-07-10
NO983878D0 (no) 1998-08-21
DE19846013A1 (de) 1999-05-20
JP3640007B2 (ja) 2005-04-20
IL125897A0 (en) 1999-04-11
GB2331246A (en) 1999-05-19
SG67545A1 (en) 1999-09-21
NO311781B1 (no) 2002-01-28
US20020010505A1 (en) 2002-01-24
UA53646C2 (uk) 2003-02-17
RU2211684C2 (ru) 2003-09-10
CZ335598A3 (cs) 1999-06-16
EE03801B1 (xx) 2002-08-15
NZ331532A (en) 2000-01-28
PL328338A1 (en) 1999-05-24
AR015161A1 (es) 2001-04-18
SK145898A3 (en) 1999-06-11

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