CN108024862A - 可扩张脉管支架 - Google Patents

可扩张脉管支架 Download PDF

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CN108024862A
CN108024862A CN201680052848.6A CN201680052848A CN108024862A CN 108024862 A CN108024862 A CN 108024862A CN 201680052848 A CN201680052848 A CN 201680052848A CN 108024862 A CN108024862 A CN 108024862A
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vascular stent
recess
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CN108024862B (zh
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M·奥布拉多维奇
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Bentley Innomed GmbH
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Abstract

一种脉管支架，特别是由在活体内可降解的塑料材料制成的脉管支架，具有单独的环节段(2)，其腹板(4)是蜿蜒构造，并且包括布置在相邻的环节段(2)之间的连接腹板(3)，所述腹板与环节段(2)的腹板(4)在连接点(7)处会聚，凹部(9a，9b)布置在当脉管支架(1)扩张时被压缩的连接点(7)的角处，所述凹部向边缘敞开，并且延伸通过环节段腹板(4)和连接腹板(3)，目的在于减小在脉管支架(1)扩张期间产生的应力。

Description

可扩张脉管支架
本发明涉及脉管支架或者血管支承件，其具有单独的环节段，环节段的腹板是蜿蜒构造，并且包括布置在相邻的环节段之间的连接腹板，所述腹板与环节段的腹板会聚在连接点。特别地，脉管支架或者血管支承件包括可在活体内分解的材料，且尤其优选的，由具有这些属性的塑料材料制成。
脉管支架通常用于冠状动脉，大脑和末梢区域中，以便膨胀和重新疏导变窄的血管以及封闭血管中的动脉瘤，分路和不希望的分支。在此背景下，越来越多地使用能够在活体内分解的材料，其经过一段预定的时间段在体内溶解。通常仅仅在有限的时间段需要血管支承件，特别是涂覆有药物的/洗脱的支架，并且在它们已经实现它们的目的时不再使用。
为了获得这样的活体内可降解的脉管支架，测试了大量的材料，既有金属性质的也有基于塑料的。在金属的情况下，证明了镁合金特别地有用。在塑料材料中，除了别的之外，已经开发了基于聚乳酸和聚半乳酸(polygalactide)的脉管支架。
用于扩宽血管的目的的脉管支架通常压接到球囊上，并且借助于导管而放置就位，且之后在所述球囊的帮助下扩张，此后，球囊在无效状态下被收回，将脉管支架留在放置部位处。在脉管支架的扩张期间，单独的环节段扩宽到更大或者更小的程度，使得它们处于张力下。然而，这样的扩宽还会导致支架的处于张力下的部分从圆柱面内移出，结果是出现了可能会导致血管损伤的边缘和翅片。
这种危险可至少部分地通过使用塑料材料而抵消。塑料比金属更软，并且形成锋利边缘的倾向较小。然而，塑料支架的缺点是它们倾向于在扩张期间在由于张力而受应力的区域中形成开裂，或者在经受压缩时严重地屈曲。尤其是在包括具有蜿蜒腹板的多个环节段的脉管支架的情况下，频繁地遇到该行为。另一方面，由于它们的径向性状，且由于它们在扩张期间的长度减小的可控性，这种类型的支架结构已经被成功地应用。
鉴于此，本发明的目的在于提供这样的结构，借助于该结构，上文所描述的张力—当它们在脉管支架的扩张期间出现时—得以降低。这不仅仅适用于特别受影响的塑料材料支架，而且也适用于金属材料的支架，不论它们是不是在活体内可降解。
该目的通过上面首先提出的类型的脉管支架而实现，其中凹部布置在当脉管支架扩张时被压缩的连接点的角处，所述凹部朝向边缘敞开，并且延伸穿过环和连接腹板，目的在于减小在脉管支架(1)扩张期间出现的应力。
在本发明意义内，术语“支架”，“脉管支架”和“血管支承件”在本文中同义地使用。这些术语并不仅仅指代脉管和冠状动脉支架，而是指代可被插入以及置于体腔内的所有血管支承件。
术语“环节段”指血管支承件的支承元件，其在周向方向上延伸。这样的环节段具有蜿蜒构造，从而脉管支架的直径可通过在扩张期间拉伸环而被扩大。该语境中的“蜿蜒”指的是具有呈弯弯曲曲的线或者曲折形状的弯曲部的构造。
取决于视角，血管支承件的单独的环节段包括弯曲延展的单个腹板或者多个腹板，该多个腹板彼此连接，从而形成蜿蜒的构型。
血管支承件的邻接环节段通过连接腹板而彼此附连。连接腹板可具有直的，弯曲的，S形的或者螺旋形的形状；根据本发明优选的是具有直的构造的连接腹板。
通常来说合乎需要的是限制支架在扩张期间的纵向收缩。在提供了弯曲的连接腹板的情况下，这通过伸展腹板来实现，且当使用直的连接腹板时—通过将它们布置在环节段外部拱与相邻的环节段的内部拱之间(来实现)。因此连接腹板布置在相邻的蜿蜒部的相应的拱之间，一方面在外部，而另一方面在内部。
一方面是环节段的腹板以及另一方面是连接腹板在连接腹板的两端上相遇，从而形成连接点。在上述构造中，三个腹板臂在各个连接点处起源。
如本发明所提议的，在一些连接点处存在凹部，它们从外部延伸到腹板中，优选地在环节段在连接腹板的结合点的区域中被压缩或者弄乱(upset)的连接点处。外部拱处的连接点通常是这种情况。凹部为环节段的被压缩的材料提供空间，以便移动到侧面，从而不会出现如上所述的突起。
凹部可以缺口或者切口的形式来提供，缺口或者切口从外部通入并且穿过腹板，但是也可为规则的切除部或者“冲孔”。优选地，凹部具有圆润的轮廓，其提供的优点在于消除了当压接在球囊上以及扩张球囊时可能会遇到的早期的开裂。特别优选的是具有圆形的或者椭圆形轮廓的凹部。凹部延伸通过腹板，并且朝向边缘或者缘边而敞开。
在连接点的角的区域中，凹部从边缘延伸到环节段腹板中，并且还覆盖连接腹板。在圆形的或者椭圆形凹部的情况下，半径优选地在腹板宽度的1/20与1/10之间的范围中。同样的情况类似地适用于切口和缺口。
备选地或者另外，环节段的腹板可在蜿蜒环节段的拱的区域中设有切口。切口以遵从环节段的路线的槽的形式提供，所述切口或者槽完全布置在腹板的内部中。优选地，它们的宽度达到腹板宽度的1/40与1/4之间，特别是腹板宽度的1/20与1/10之间。切口为环节段提供柔性，并且适用于容纳在压缩期间被移位的材料。
切口或者槽优选地布置在环节段的连接点的区域中，在连接腹板与内部拱邻接的地方。在该位置，在与连接腹板相反的一侧上的环节段设有凹口或者凹陷，其轮廓之后是切口。
通常，切口在对应于单个到三个腹板宽度的长度上延伸。
特别地，切口或者槽也可布置在环节段的拱的区域中，此处，它们遵从腹板的路线。
血管支承件的创造性设计特别地适用于从塑料材料，例如可降解塑料，切割的支架。这样，聚乳酸，聚半乳酸，它们的共聚物和混合物特别地适用。然而，要理解，本发明涉及由任何材料制成的血管支承件；哪种材料用于支架并没有关系。
本发明所提出的支架是这种类型的常规的球囊-可扩张支架：其以通常的方式压接到球囊上，借助于球囊导管被带到放置部位，并且液压地扩张，此后在球囊处于瘪缩状态时缩回导管。不言自明的是，支架可以本身已知的方式被涂覆或者浸渍有活性剂，例如，以便在变窄的血管的情况下防止再窄化。
本发明通过附图更详细地阐述，在附图中
图1显示了呈扩展形式的常规支架设计；
图2是图1中所示的支架设计的部分截面，其已根据本发明而修改；
图3显示了图2中所示的设计的关于凹部和切口的修改；
图4示出了图2中所示的设计的另外的修改；
图5描绘了图2中所示的设计的包括切口的另外的修改；
图6是在支架膨胀之前的根据图2的样品的摄影表示；且
图7显示了在支架已经膨胀之后的图6的截面。
在图1中，显示了常规支架1，其具有蜿蜒环节段2和以切割和扩展的形式布置在相邻的环节段2之间的连接腹板3。单独的环节段包括连续的腹板4，其遵从蜿蜒或者弯弯曲曲的路线，在连接腹板3处具有外部拱5，内部拱6和连接点7。连接腹板3的连接点7处的内部拱6具有槽沟形的凹陷8。连接腹板3的宽度比环节段2的腹板宽度略小大约5％到20％。
图2显示了图1中描绘的支架设计的细节，示出了创造性的凹部9a和9b。凹部9a和9b是两个独立的变体，它们各自可单独地实现，所述凹部布置在环节段2与连接腹板3之间的连接点7的角中。两个凹部9a和9b具有圆润的轮廓，并且成形为形成了并入环节段2与连接腹板3的边缘中的圆润的过渡。两个凹部9a和9b以这样的方式布置，使得它们覆盖连接腹板3和环节段2两者，其中凹部9b具有大于凹部9a的直径。
图3显示了关于连接点7的设计的另一种变体，其中凹部9a布置在形成于连接腹板3和环节段2之间的角中。在凹部9a其中之一周围，布置切口10，切口10几乎是半圆形形状的，并且围绕凹部9a。
图1和2中所示的凹部9a和9b以及切口10位于支架1的在扩张期间经受压应力的区域中。通过凹部，产生了自由空间，材料可在扩张过程期间移位到该自由空间中，见图6/7，且此外，凹部的圆润的轮廓有助于防止开裂的形成。
图4显示了创造性支架的另一实施例，其中凹部9a布置在连接点7中。连接腹板3从外部拱5(其也代表连接点7)延伸到相邻的环节段2的内部拱6。在与腹板3和内部拱6相对的位置处，环节段2设有凹陷或者槽沟8。由于这样的槽沟状构成，内部拱6被伸长，并且容许从连接腹板3到环节段2的过渡的更平滑的倒圆。
在图5中，支架1的另一实施例变体如本发明所建议显示为处于位于两个环节段2之间的连接腹板3的区域中。连接点的区域中的凹部9a可由半圆形的槽10围绕。此外，遵从环节段2的路线的狭缝形的切口11和12位于布置在设有凹部9a的环节段2附近的环节段2a上。所述槽适用于平衡在支架扩张期间产生的应力。
图6显示了在环节段2与腹板3之间的连接点7的区域中包括凹部9a的支架截面的摄影表示。
图7是在支架扩张之后图6中所示的支架的同一区域的表示；凹部已经由于材料从环节段2移位而被闭合。
不言自明的是，图中所示的以及借助于说明书而解释的特性在所有情况下都应当被单独地考虑，但是它们也可适用于其它环境中。因此，可在支架中提供切口和/或凹部的可选的结合。仅在连接点的区域中设有凹部的血管支承件，以及仅仅在腹板构造的区域中具有切口或者槽的支架，因此也落入本发明的范围中。

Claims (15)

1.一种脉管支架，特别是由在活体内可降解的塑料材料制成的脉管支架，其具有单独的环节段(2)，单独的环节段(2)的腹板(4)具有蜿蜒构造，并且包括布置在相邻的环节段(2)之间的连接腹板(3)，所述腹板与所述环节段(2)的所述腹板(4)会聚于连接点(7)，
其特征在于，凹部(9a，9b)布置在所述连接点(7)的角处，其在所述脉管支架(1)被扩张时被压缩，所述凹部朝向边缘敞开，并且延伸通过所述环节段腹板(4)和连接腹板(3)，以便减小在所述脉管支架(1)的扩张期间产生的应力。
2.根据权利要求1所述的脉管支架，其特征在于，延伸通过所述腹板(4，3)的切口(10)布置在所述凹部(9a，9b)周围，所述凹部(9a，9b)位于其中提供了凹部(9a，9b)的连接点(7)的角处。
3.根据权利要求1或者2所述的脉管支架，其特征在于，所述凹部(9a，9b)具有圆润的轮廓。
4.根据权利要求3所述的脉管支架，其特征在于，所述凹部(9a，9b)具有基本圆形的或者椭圆形的形式。
5.根据权利要求4所述的脉管支架，其特征在于，所述凹部(9a，9b)具有介于所述环节段的所述腹板的宽度的1/20与1/10之间的范围中的半径。
6.根据前述权利要求中的一项或者若干项所述的脉管支架，其特征在于，所述环节段(2)的所述腹板(4)设有遵从所述腹板的路线的切口(10，11，12)。
7.根据权利要求6所述的脉管支架，其特征在于，所述切口(10，11，12)布置在所述腹板的、在所述脉管支架的扩张期间被压缩的区域中。
8.根据权利要求6或7所述的脉管支架，其特征在于，所述切口(10，12)布置在所述连接点(7)的区域中。
9.根据权利要求6或7所述的脉管支架，其特征在于，所述切口(11)布置在所述环节段的拱的区域中。
10.根据权利要求6-9中的一项或者若干项所述的脉管支架，其特征在于，所述切口(10，11，12)是槽，其具有所述腹板宽度的1/40到1/4，特别地1/20到1/10，的宽度。
11.根据前述权利要求中的一项或者若干项所述的脉管支架，其特征在于，所述连接腹板(3)连接环节段(2)的外部拱与相邻的环节段(2)的内部拱。
12.根据权利要求11所述的脉管支架，其特征在于，所述连接腹板(3)邻接于所述环节段(2)的内部拱中，所述环节段(2)的拱在与接合点相对的位置处设有槽沟状凹陷(8)。
13.根据权利要求12所述的脉管支架，其特征在于，所述切口(12)遵从所述槽沟状凹陷(8)的路线。
14.根据前述权利要求中的一项或者若干项所述的脉管支架，其特征在于，所述支架包括可在活体内降解并且可借助于球囊而扩张的塑料材料。
15.根据权利要求14所述的脉管支架，其特征在于，所述脉管支架包括聚交酯，聚丙交酯或者它们的混合物或者共聚物。
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