CN1280475A - 主动脉内腔斯滕特固定模 - Google Patents

主动脉内腔斯滕特固定模 Download PDF

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CN1280475A
CN1280475A CN98811852A CN98811852A CN1280475A CN 1280475 A CN1280475 A CN 1280475A CN 98811852 A CN98811852 A CN 98811852A CN 98811852 A CN98811852 A CN 98811852A CN 1280475 A CN1280475 A CN 1280475A
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prosthese
biocompatible material
perforation
material pipe
shaped stent
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CN1158051C (zh
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D·E·哈特利
T·F·布朗尼
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William A Cook Australia Pty Ltd
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Abstract

一种假体包括缝合于一移植物(5)上的Z形斯滕特固定模(7,8),所述移植物包括一诸如涤纶织物的生物相容材料管。所述Z形斯滕特固定模附着于所述生物相容材料管的内表面,并且在与一相交主动脉开口相对应的所述涤纶管上有至少一个穿孔(10)。另一Z形斯滕特固定模(1)在邻端延伸并可从具有一些面朝着尾部的倒刺(2)。每一穿孔包括一个或多个在所述穿孔的周缘的不透射线标记。一用于所述假体的释放机构包括一些缝入一涤纶织物一折边内的触发金属线,以在展开过程中将所述假体保持在部分压缩状态。一传送装置具有一可在插入过程中将受压的假体保持住的护套以及一可将顶部斯滕特固定模保持住的顶帽。

Description

主动脉内腔斯滕特固定模
引言
本发明总的涉及主动脉疾病的治疗领域，特别涉及主动脉内腔斯滕特固定模和展开斯滕特固定模的使用方法，它可以将一被覆盖的斯滕特固定模精确地放置在主动脉内。更具体地说，它可以在肾下主动脉动脉瘤疾病的治疗中，将所述斯滕特固定模精确地展开和定位在肾脏动脉的上方。
本发明的背景
根据已有技术，主动脉疾病通常是藉助包括使用斯滕特固定模和移植物在内的手术技术来加以治疗的。例如，在本技术领域中众所周知的是，在一动脉的异常狭窄部分内部，采用一由不锈钢或其它材料制成的斯滕特固定模，该斯滕特固定模能像气球那样膨胀，从而可以增强一异常狭窄或闭塞的动脉的各壁面的强度。此外，在已有技术中还众所周知的是，采用一移植物来修复高度受损的部分，例如，主动脉或其它动脉，从而可以确保血液流动并降低动脉瘤或血管破裂的危险。所述移植物、由诸如涤纶之类的材料制成的中空管通常是插设在一受损动脉的各壁面内，并且可以缝制就位或借助使用一斯滕特固定模式的带气囊导管加以膨胀。
当必需在一主要动脉(例如，主动脉)和相连(相交)动脉(例如，肾动脉、颈动脉或短头畸形动脉)的相交处或该相交处周围使用移植物时，会发生更为严重的问题。虽然很明确要用所述移植物来加强和确保血液流过例如主动脉，但是，移植物的使用恰恰密封或堵塞了血液至肾脏或脑的循环。因此，在主动脉和其它动脉的相交处或该相交处周围使用一移植物来治疗主动脉疾病通常就变成不太可能或不切实际的。为此，医生必须试图利用其它的手术技术对这种动脉的脆弱壁面加以修复，但这样做具有很高的失败率和有限的成功率。例如，虽然全世界的几个中心已常规地采用了用于肾下主动脉瘤治疗的内腔移植物，但是，由于无动脉瘤的肾下主动脉的长度不足以将所述移植物或斯滕特固定模牢固地固定，因此，高达30％的腹部主动脉瘤不适用于这种治疗方法。
本发明藉助采用上肾主动脉将一主动脉移植物适当固定，与此同时将一穿孔的、覆盖的斯滕特固定模非常精确地定位在与相交动脉起始处的精确位置相对应的位置，来解决已有技术的上述问题，
本发明的简要描述
本发明总的涉及一种穿有孔的主动脉内腔斯滕特固定模，它是一包括两个或多个不锈钢或镍钛金属互化物Z形斯滕特固定模的单构件式装置，所述Z形斯滕特固定模具有一些面朝着尾部的倒刺，并缝合于一长度可变的生物相容材料管上，在所述生物相容材料管内，Z形斯滕特固定模附着于所述生物相容材料管的内表面，并可根据需要覆盖的相交动脉的几何形状，将定制的各穿孔精确地设置在与相交动脉开口相对应的所述生物相容材料管上。
因此，可以说本发明一方面旨在提供一种假体，它包括缝合于一移植物上的两个或多个Z形斯滕特固定模，所述移植物包括一生物相容材料管，其特点是，所述的两个或多个Z形斯滕特固定模附着于所述生物相容材料管的内表面以及所述生物相容材料管上有至少一个与一相交主动脉的开口相对应的穿孔。
较佳的是，有两个以上的Z形斯滕特固定模附着于所述生物相容材料管。
还可以有另一个Z形斯滕特固定模，该Z形斯滕特固定模固定于所述生物相容材料管并自所述生物相容材料管邻近地延伸出来。
所述Z形斯滕特固定模的至少其中之一上可以具有一些面朝着尾部的倒刺，以在该固定模完全插入时有助于精确地固定假体。
所述邻近地延伸的Z形斯滕特固定模上可以是具有一些面朝着尾部的倒刺的斯滕特固定模。
在一实施例中，所述生物相容材料管可以是一涤纶材料管。
可以根据相交动脉的个数设置两个或多个穿孔。
所述穿孔或每一穿孔可以包括一个或多个能在所述穿孔的周缘形成不透射线的标记。
所述Z形斯滕特固定模的最末端可以包括一在所述移植物末端延伸的环。
所述假体还包括一用于所述假体的释放机构，它包括一根或多根触发金属线，其中所述生物相容材料管的一部分可纵向地折叠起来，并且所述的一根或多根触发金属线分别在折边处纵向地穿过所述生物相容材料管，以将所述假体保持在部分压缩状态。
所述Z形斯滕特固定模的至少其中之一可以包括一根或多根可根据需要对各穿孔进行定位的短环。
主动脉分支的精确定位可以藉助计算机轴向X线断层摄影术(CT)和血管造影术来实现，本发明可为每一病人根据与CT相对应的各位置定制。这些穿孔标记有一些不透射线的小珠，从而便于在展开之前、在X射线控制之下对它们进行定位。
本发明的另一方面可以说是提供了一种用来在两动脉相交处对动脉疾病进行治疗的方法，它包括以下步骤：
用X射线照射待治疗的各动脉，从而可以精确地确定各动脉的相交位置；在一包括一具有选定长度的生物相容材料管的假体上定制一个或多个穿孔；将一些不透射线的标记设置在所述各穿孔或每一穿孔周围；将两个或多个Z形斯滕特固定模放入所述生物相容材料管内，并且如果需要，以一种不会将各穿孔覆盖住的方式、将Z形斯滕特固定模内的弯曲处弄短；用手将一顶部Z形斯滕特固定模收拢起来，用一顶帽将所述顶部Z形斯滕特固定模覆盖住，并用一触发金属线将所述Z形斯滕特固定模保持在所述顶帽内的适当位置；将一穿过一纵向折边的所述触发金属线或另一触发金属线缝制在所述生物相容材料管内，以使所述假体的直径变窄；由此可将一定制的、穿孔的、被覆盖的移植物插入待治疗的动脉内。
所述方法还可以包括以下步骤：将另一Z形斯滕特固定模缝合于所述生物相容材料管的顶圈，使所述的另一Z形斯滕特固定模可以在邻近处、从所述生物相容材料管上延伸出来。
根据相交动脉的个数，可以有两个以上的所述Z形斯滕特固定模附着于所述生物相容材料管内并且可以有两个或两个以上的穿孔。
插入所述移植物的过程可以包括以下步骤：对所述移植物进行压缩，并将它放入一护套内，所述护套紧紧地安装在所述顶帽、所述假体、所述Z形斯滕特固定模和一填塞体周围；利用一包括所述顶帽、所述护套、所述填塞体和导向金属线的传送装置，通过一腹股沟内的股动脉将假体插入；将所述护套取出，以使所述移植体露出并处于半展开位置；对所述假体进行定位；将所述护套和填塞体部分地取出，以便能插入血管造影导管和导向金属线；通过一对侧腹股沟将所述血管造影导管和导向金属线插入待治疗的动脉内，从而可藉助对穿过各穿孔而插入所述相交动脉内的左、右血管造影导管和导向金属线对假体加以精确定位；释放所述触发金属线，从而可以将所述移植物完全展开；取出所述血管造影导管；将所述护套和填塞体通过所述斯滕特固定模向上推，并与所述顶帽对接(接合)，从而可将所述传送装置完全取出；这样，所述完全展开的斯滕特固定模可确保血液在待治疗动脉的相交处的流动。
将本发明假体在完全展开之前就位的方法是可藉助左、右血管造影导管和导向金属线来进行的。
所述不透射线标记可以由金或能其它能使所述标记藉助X射线或其它方法而显形的生物相容材料制成。
以上对本发明作了总的描述，但是为了更好地理解本发明，下面将结合附图，对本发明的几个较佳实施例加以描述。
附图简要说明
下面将结合附图，对本发明的一实施例进行具体描述。在各附图中：
图1是本发明一实施例的外形图，它示出了顶部Z形斯滕特固定模、具有一些穿孔和不透射线小珠的生物相容材料管，以及位于所述生物相容材料管底部的金属环；
图2是本发明所述实施例的内部结构图，它示出了一些内部Z形斯滕特固定模，以及它们与那些用于相交动脉的各穿孔之间的相互关系；
图3是本发明所述实施例的外部立体图，它示出了生物相容材料管的材料是如何藉助一穿过的触发金属线向后收折并保持在位的。与生物相容材料管的材料内表面相连的所述Z形斯滕特固定模其后部是不完整的，从而可以利用一通过所述材料的触发金属线而将所述生物相容材料管材料的一部分折合起来并加以保持；
图4是本发明所述实施例在释放所述触发金属线之前的剖视图；
图5是本发明所述实施例在释放所述触发金属线之后的剖视图。所述触发金属线已被拔出，并且被折合起来的生物相容材料管已展开，从而可以使所述斯滕特固定模最大程度地扩张，由此可借助一径向力将它保持在动脉壁上；
图6是所述主动脉和肾动脉的视图，其中，本发明所述实施例的假体位于所述传送装置内。本发明的顶部Z形斯滕特固定模已藉助用手而聚拢在一起，并被一顶帽所覆盖，而本发明的下部则紧贴地位于所述填塞体上方和护套内部，所述填塞体和护套都套一导向金属线上，所述导向金属线可将本发明安装在正确位置；
图7是本发明该实施例的假体在它脱离所述护套而处于与两肾动脉相对的半展开位置、也就是在释放触发金属线之前的视图；
图8是本发明该实施例的假体处于一半展开位置时的视图，其中，本发明的各穿孔已被一来自于对侧腹股沟的导向金属线穿过，两个血管造影导管则套在所述导向金属线上，以在完全展开之前，也就是在所述触发金属线释放之前将所述斯滕特固定模牢固地固定在正确位置；
图9是本发明该实施例的假体处于完全展开状态，也就是在释放了所述触发金属线之后但血管造影导管和顶帽仍保持在适当位置时的视图；
图10是本发明该实施例假体处于完全展开状态、且血管造影导管和它们的导向金属线已取出、所述传送装置的护套和填塞体被向上推而与所述顶帽相接合以准备取出所述传送装置时的视图；以及
图11是本发明该实施例的假体处于完全展开状态的视图，血液已可流至肾动脉，此时已取出了所述护套、填塞体和顶帽。
本发明一较佳实施例的描述
本发明总的涉及主动脉疾病的治疗领域，特别涉及可将一穿孔的、被覆盖的斯滕特固定模精确地放置在主动脉内的主动脉内腔斯滕特固定模。更具体地说，它可以在肾下主动脉动脉瘤疾病的治疗中，将所述斯滕特固定模精确地展开和定位在肾脏动脉的上方。
各附图示出了包括所述方法在内的几个基本步骤，并示出了本发明一实施例的特征。
图1和图2是本发明一实施例的外形视图。一由不锈钢或镍钛金属互化物制成的、近端Z形斯滕特固定模1缝制于一生物相容材料管5的顶圈4上，所述斯滕特固定模具有一些面朝着尾侧的倒刺2。该近端Z形斯滕特固定模1在邻近端处、从生物相容材料管5延伸出来。另有两个不锈钢或镍钛金属互化物Z形斯滕特固定模7和8安装在生物相容材料管5的内部。这些Z形斯滕特固定模以一定的间隔缝制于所述生物相容材料管上，但部分的所述生物相容材料管没有缝制，以便能在所述生物相容材料管内进行纵向折合，这将在下文中予以描述。穿孔10设置在生物相容材料管5上，穿孔为所述材料管上提供开口从而可以在使用时与肾动脉或其它动脉对准。各穿孔10的尺寸和相对于肾动脉的位置是根据计算机X线体层摄影术和血管造影术来定制的，而且它们的周缘标记有一些金制的不透射线的小珠11，这些小珠有助于利用X射线来对各穿孔进行辨认。在Z形斯滕特固定模8的其中一个有一较长的环12，它在所述生物相容材料管5的末端延伸，并可将所述斯滕特固定模的前部保持在所述传送装置内部，这将在下文中予以描述。
图2是所述假体的内部结构视图，从图2中可以看到，有一作为顶部内Z形斯滕特固定模7的一缩短的环13，它可以使那些用于肾动脉的各穿孔设置在所需位置。
图3是所述假体的立体图，其中，Z形斯滕特固定模的那些邻端环状物14已被用手聚拢在一起，以便于将它们插入到一近端的囊(capsule)(未示)内。一触发金属线17用来将各环状物保持在所述囊的内部。该触发金属线或另一触发金属线15可以用来将一纵向褶缝保持在生物相容材料管5内，从而可以使所述直径变窄，并可将多余材料折边16留在所述假体的侧面。触发金属线17还穿过长环12，从而有助于在拔出护套之后对所述假体的末端的保持，这将在下文中予以描述。这样就能使所述假体在动脉内部作旋转，以便在最终释放之前将它精确定位。触发金属线15间隔地插入并穿过涤纶或其它材料的表面，从而产生了一系列缝线脚，由此形成了缝状的材料折边16，这在图4中可以清楚地看到。
图4是在将触发金属线15从材料折边16中释放之前的所述假体的剖视图。藉助缝制上去的触发金属线15而保持在位的缝状折边16，提供了一小于主动脉直径的直径，从而在将本发明从护套上取下来并在插入导管之后可使所述假体上、下运动并作360度旋转，这将结合图8在下文中予以描述，以确保各穿孔相对于肾动脉精确定位。
图5示出了在释放触发金属线之后、所述假体处于完全展开状态的剖视图。
图6示出了主动脉30、延伸伸入肾脏35的肾动脉32和34、股动脉36、38和借助一腹股沟切口而将本发明的假体18导入主动脉30的所述传送装置。
以编号20总的标示的所述传送装置插套在一覆盖塑料层的金属导向线22上，并包括一安装在柔性钢管23上的、不锈钢制成的近端帽24。近端帽24将近端的Z形斯滕特固定模的顶部和一护套26覆盖住，所述护套可将包括生物相容材料管5和Z形斯滕特固定模的其余部分在内的假体覆盖住，并且在插入过程中在一部分近端帽24上延伸。护套26套在一塑料填塞体28上，所述填塞体足够长，从而可从股动脉和腹股沟切口中突伸出来，由此用手可使其移动。塑料填塞体28滑动配合在柔性钢管23上。填塞体28紧贴地设置在所述护套之下，当插入并随后在所述填塞体上将所述护套拉回时，可将所述假体保持在位，如图7所示，从而可以使穿孔的斯滕特固定模暴露呈图3所示的半展开状态。
在图7中，护套26已藉助不让柔性钢管23和填塞体28之间作相对运动而退回到填塞体28上，同时将填塞体28和近端帽24留在原来的位置上。假体18然后就可以藉助柔性管23的移动而自由旋转和纵向移动，一直到穿孔10和11相对于肾动脉32和34正确定位为止。
图8示出了主动脉30、延伸伸入肾脏35的肾动脉32和34、股动脉36和38以及传送装置20，其中，填塞体28和护套26已后退至其中一根股动脉36。这是藉助将柔性钢管23保持固定并使护套26和填塞体28相对于柔性钢管移动来实现的。触发金属线15保持在适当位置。这样就给导向金属线40和42以及血管造影导管44和46留出了进入的地方，所述血管造影导管已借助对侧的腹股沟切口(未示)插入并向上通过对侧股动脉38，所示置于所述肾动脉内，这些都是由左、右血管造影导管44和46导向的。这些血管造影导管44和46设计成分别具有左、右弯曲颈部，从而可以将所述金属线从主动脉30导引至适当的肾动脉32和34。将导向金属线40、42和血管造影导管44、46插入肾动脉32和34内，从而可以对本发明该实施例的假体的穿孔10和11进行安全和精确地定位。
图9是在将触发金属线15和17或能实现所述两个触发金属线功能的单根触发金属线释放之后、而导向金属线40和42、血管造影导管44和46以及传送装置20仍保持在适当位置时、本发明处于完全展开状态的视图。在这种状态时，近端Z形斯滕特固定模1向外扩张至主动脉30的壁，并且各倒刺2与所述主动脉壁啮合，从而可将假体18保持在所述正确位置。
在图10中，血管造影导管44、46和导向金属线40、42已通过对侧的股动脉38而取出，而且填塞体28和护套26已被向上推从而可与近端的帽24进行接合，以准备取出整个传送装置20。这是藉助将柔性钢管23保持不动并使填塞体28和护套26相对于柔性钢管并朝着所述近端帽移动来实现的。
图11是本发明假体18处于完全展开状态并且传送装置20已取出从而可使血液自由地流过主动脉30并借助穿孔10和11而流入肾动脉32和34的视图。
应该在展开后进行血管造影术以确定假体是否正确展开。各穿孔是否正确定位。
下面是可以对本发明作出的种种可能是有利的改进。
例如可以将2个以上的Z形斯滕特固定模与所述生物相容材料管相连并安装在其内。如果要求本发明的移植物更长些，就要采用两个以上的Z形斯滕特固定模。
可以分别用一根或两根触发金属线、(a)事后或(b)事先和事后、在内部将所述释放机构收折起来。
在所述生物相容材料管内、在有两个以上相交动脉之处可以有两个以上的穿孔。
在本说明书和下面的权利要求书中，除非文中有特殊要求，术语“包含”和“包括”以及诸如“含有”和“包括有”之类的有所变化的术语的应理解成是指包含一确定的整体或整体组，但不将其它的整体或整体组排除在外。

Claims (16)

1．一种假体，它包括缝合于一移植物上的两个或多个Z形斯滕特固定模，所述移植物包括一生物相容材料管，其特征在于，所述的两个或多个Z形斯滕特固定模附着于所述生物相容材料管的内表面，并且在与一相交主动脉开口相对应的所述生物相容材料管上有至少一个穿孔。
2．如权利要求1所述的假体，其特征在于，有两个以上的Z形斯滕特固定模附着于所述生物相容材料管。
3．如权利要求1所述的假体，其特征在于，它还包括另一个Z形斯滕特固定模，该Z形斯滕特固定模固定于所述生物相容材料管并自所述生物相容材料管近端延伸出来。
4．如前述任一权利要求所述的假体，其特征在于，所述Z形斯滕特固定模的至少其中之一上具有一些面朝着尾部的倒刺。
5．如权利要求3所述的假体，其特征在于，所述近端地延伸的Z形斯滕特固定模上具有一些面朝着尾部的倒刺。
6．如前述任一权利要求所述的假体，其特征在于，根据相交动脉的个数，有两个或多个穿孔。
7．如前述任一权利要求所述的假体，其特征在于，所述穿孔或每一穿孔包括一个或多个在所述穿孔的周缘的不透射线的标记。
8．如前述任一所述权利要求所述的假体，其特征在于，所述Z形斯滕特固定模的最末端包括一在所述移植物末端延伸的环。
9．如前述任一权利要求所述的假体，其特征在于，它还包括一用于所述假体的释放机构，该释放机构包括一根或多根触发金属线，其中所述生物相容材料管的一部分可纵向地折叠起来，此时，所述的一根或多根触发金属线分别在折边处纵向地穿过所述生物相容材料管，以将所述假体保持在部分压缩状态。
10．如前述任一权利要求所述的假体，其特征在于，所述Z形斯滕特固定模的至少其中之一包括一根或多根可根据需要对各穿孔进行定位的短环。
11．一种用来在两动脉相交处对动脉疾病进行治疗的方法，其特征在于，它包括以下步骤：
用X射线照射待治疗的各动脉，从而可以精确地确定各动脉的相交位置；
在一包括一具有选定长度的生物相容材料管的假体上定制一个或多个穿孔；
将一些不透射线的标记附着于所述各穿孔或每一穿孔周围；
将两个或多个Z形斯滕特固定模放入所述生物相容材料管内，并且如果需要，以一种不会将各穿孔覆盖住的方式、将Z形斯滕特固定模内的弯曲处弄短；
用手将一顶部Z形斯滕特固定模收拢起来，用一顶帽将所述顶部Z形斯滕特固定模覆盖住，并用一触发金属线将顶帽保持在位；
将一穿过一纵向折边的触发金属线缝制在所述生物相容材料管内，以使所述移植物的直径变窄；
由此可将一定制的、穿孔的、被覆盖的移植物插入待治疗的动脉内。
12．如权利要求11所述的方法，其特征在于，它还包括以下步骤：将另一Z形斯滕特固定模缝合于所述生物相容材料管的顶圈，这样所述的另一Z形斯滕特固定模可以在近端从所述生物相容材料管上延伸出来。
13．如权利要求11所述的方法，其特征在于，插入所述移植物的过程包括以下步骤：
对所述移植物进行压缩，并将它放入一护套内，所述护套紧紧地安装在所述顶帽、所述假体、所述Z形斯滕特固定模和一填塞体周围；
利用一包括所述顶帽、所述护套、所述填塞体和导向金属线的传送装置，将一假体通过一腹股沟内的股动脉插入；
将所述护套取出，以使所述移植体处于半展开位置；
对所述假体进行定位；
将所述护套和填塞体部分地取出，以便能插入血管造影导管和导向金属线；
通过一对侧腹股沟将所述血管造影导管和导向金属线插入待治疗的动脉内，从而可藉助对穿过各穿孔而插入所述相交动脉内的左、右血管造影导管和导向金属线加以定位，进而对所述移植物进行调节和精确定位；
释放所述触发金属线，从而可以将所述移植物完全展开；
取出所述血管造影导管；
将所述护套和填塞体通过所述斯滕特固定模向上推，并和所述顶帽相接合，从而可将所述传送装置完全取出；
由此，所述完全展开的斯滕特固定模可确保血液在待治疗动脉的相交处的流动。
13．如权利要求11所述的方法，其特征在于，有两个以上的所述Z形斯滕特固定模附着于所述生物相容材料管。
14．如权利要求11所述的方法，其特征在于，根据相交动脉的个数，可以有两个或两个以上穿孔。
15．如权利要求11所述的方法，其特征在于，所述不透射线标记由金或能其它能使所述标记藉助X射线或其它方法而显形的生物相容材料制成。
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JP4152072B2 (ja) 2008-09-17
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CN1158051C (zh) 2004-07-21

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