CN103209659B - 具有面对的侧分支口的支架移植物 - Google Patents

具有面对的侧分支口的支架移植物 Download PDF

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CN103209659B
CN103209659B CN201180054555.9A CN201180054555A CN103209659B CN 103209659 B CN103209659 B CN 103209659B CN 201180054555 A CN201180054555 A CN 201180054555A CN 103209659 B CN103209659 B CN 103209659B
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bifurcations
stent graft
side bifurcations
branch
longitudinal axis
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CN103209659A (zh
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E·E·肖
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WL Gore and Associates Inc
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    • A61F2/00Filters 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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Abstract

在各个实施例中,用于治疗血管疾病的装置包括支架移植物(100),该支架移植物具有外表面;至少两个侧分支口(110),每个侧分支口具有近端和远端。各远端与支架移植物的外表面基本邻接。在各个其它实施例中,远端在大体轴向上比近端隔得更开。

Description

具有面对的侧分支口的支架移植物
相关申请的交叉引用
本非临时专利申请要求2010年11月15日提交的、名称为“STENT-GRAFThavingfacingsidebranchportals(具有面对的侧分支口的支架移植物)”的临时专利申请第61/413,855号的优先权和权益,在此以参见的方式整体引入该专利申请的内容。
技术背景
技术领域
本发明涉及用于治疗血管疾病的支架移植物。
相关技术的讨论
血管疾病越来越普遍,且由于血管的曲折性和复杂性而对于医师来说难以治疗。例如,主动脉解剖通常开始于主动脉瓣根部之处或附近,并继续至升主动脉和主动脉弓,还会影响降主动脉的上部。三条分支血管离开主动脉弓,即,头臂动脉、左颈总动脉和左锁骨下动脉,它们在解剖学上难以被医师触及而难以最终有效治疗。
血管疾病目前采用外科手术治疗(即,开放式修复、血管内修复或两者的混合)。本领域已知的主动脉弓修复外科手段包括象鼻管修复和三叉移植物技术。然而,现有的手段常常是非常侵入性的和/或需要特殊设计的移植物。
因此,本领域需要用于治疗血管疾病的、改进的、较小侵入性的且简化的装置、系统和方法。
发明内容
在各个实施例中,公开了用于治疗血管疾病的装置、系统和方法,该血管诸如升主动脉、主动脉弓和降主动脉。在各个实施例中,支架移植物设有至少两个侧分支口,每个侧分支口具有近端和远端。侧分支口的远端与支架移植物的外表面邻接。在各个实施例中,侧分支口具有肘状构造,从而其近端可定向成在支架移植物内顺行/逆行。在还有其它各个实施例中,侧分支口具有T形构造,从而其近端裂开且可定向成顺行/逆行。在各个实施例中,具有T形构造的一个或多个侧分支口位于具有肘状构造的侧分支口之间。在各个实施例中,支架移植物包括具有肘状构造的侧分支口,侧分支口的近端面向彼此(例如,顺行/逆行)。
在各个实施例中,侧分支口的远端在大体轴向上比近端隔得更开。
一示例性系统包括如上所述具有至少两个侧分支口的支架移植物,该支架移植物被挤压加载,被套管保持或以其它方式容纳在套管内,管状元件通过侧分支口,从而保持用于分支线的通路。在一实施例中,管状元件的近端和远端通过套管中的不同狭缝延伸离开支架移植物。根据一实施例的一方面,管状元件的远端是封闭的。
另一示例性系统包括如上所述具有至少两个侧分支口的支架移植物、以及安装在该支架移植物近端处的一个或多个侧分支支架移植物和/或一个或多个延伸件。
根据一示例性方法,具有至少两个侧分支口的支架移植物被挤压加载,被套管保持或以其它方式容纳在套管内,且沿引导线输送至治疗位置。一旦在位,支架移植物就可展开,且侧分支支架移植物可安装在侧分支口处。
在使用包括具有肘状构造的侧分支口且侧分支口的近端面向彼此的支架移植物的示例性实施例中,支架移植物可被挤压加载,管状元件通过侧分支口,从而保持用于分支线的通路。此后,支架(被挤压加载在套管中)沿引导线输送至治疗位置,支架展开,侧分支支架移植物可沿分支线通过且安装在侧分支口处。一个或多个延伸件可根据需要安装在支架移植物的近端处。
附图说明
本发明的特征和优点将结合附图从下文所述的详细描述中变得更加明显。
图1a示出了包括具有肘状构造的侧分支口的一示例性支架移植物,侧分支口的近端面向彼此且对准在单个或平行的平面上。
图1b示出了图1a的前视剖面图。
图1c示出了一示例性支架移植物的俯视图,该支架移植物包括位于具有肘状构造的外部侧分支口之间的、具有T形构造的侧分支口。
图1d示出了图1c的前视剖面图。
图2a示出了穿过具有肘状构造的示例性侧分支口的分支线,侧分支口的近端面向彼此。
图2b示出了一示例性输送构造,其中,支架移植物被挤压加载,管状元件通过侧分支口。
图3示出了示例性的主动脉弓旁路构造。
图4示出了根据一示例性实施例的、包括引导线和分支线的方法。
图5a示出了根据一示例性实施例的、位于治疗位置的挤压加载支架移植物。
图5b示出了根据一示例性实施例的、带有位于治疗位置的侧分支支架移植物的已展开支架移植物。
图6a示出了一示例性的单分支。
图6b示出了一示例性的动脉瘤延伸件。
图6c示出了一示例性的冠状动脉延伸件。
具体实施方式
本领域的技术人员应容易理解到可以通过任意数量的构造成实现所需功能的方法和设备来实现本发明的各个方面。换言之,其它方法和设备可包含到文中以实现所需的功能。还应注意,本文中的附图并不是全部按比例绘制的,而是可以放大以显示本发明的各个方面,在此方面,附图不应解释为具有限制性。最后,尽管本发明可结合各种原理和理念来描述,但本发明不应受理论的限制。
根据各示例性实施例,本发明提供用于治疗血管疾病的、改进的、较小侵入性的且简化的装置、系统和方法。各示例性实施例使分支线能分支到分支定位,这大大简化了侧分支支架移植物的定位,用于将较大的支架移植物安装在侧分支口处。
将主要参照治疗升主动脉、主动脉弓和降主动脉疾病来描述本发明,然而,本发明也可应用于其它血管疾病,例如要治疗大血管和一个或多个分支血管的任何疾病。
参见图1a-1b,根据各个实施例的支架移植物100具有至少两个侧分支口110。在其扩张构造中,示例性的支架移植物直径可与待修复血管的直径大致相等。在另一实施例中,扩张的支架移植物直径可比待治疗血管略大,从而在血管内提供摩擦配合。类似地,示例性的扩张侧分支口直径可与待修复血管的直径大致相等。较佳地,横截面是圆形的,但其它横截面也可适用,包括但不局限于以下型面:“D”形、卵形、三角形、方形、多边形或任意形状。
支架移植物和侧分支口可包括本领域现在已知或以后发现的材料,例如,镍钛诺螺旋或环结构和一个或多个ePTFE覆盖物(例如,在腔和/或近腔表面上的一个或多个涂层)。图1a例如示出了支架移植物,该支架移植物包括沿支架移植物100长度的多个锯齿形环103,并具有在腔和近腔表面上的ePTFE涂层105。其它有用的材料可包括尼龙、聚碳酸酯、聚乙烯、聚丙烯、聚四氟乙烯、聚氯乙烯、聚氨酯、聚硅氧烷、不锈钢或其它生物相容材料。
支架移植物和侧分支口可包括相同或不同的材料,并可通过现在已知或尚未知晓的方法一起联接成模块化元件,该方法例如是过盈配合、粘合、缝合、夹住等。在另一实施例中,支架移植物和侧分支口是一体形成的。
在各示例性实施例中,侧分支口包括近端112和远端114。在各示例性实施例中,侧分支口的远端114与支架移植物100的外表面基本邻接,而在其它实施例中,远端114从支架移植物100的外表面侧向向外延伸。各示例性实施例中的远端可以是隔开的,例如根据待治疗分支血管的间隔。支架移植物可包括两个或更多个侧分支口,其一些或全部远端114的中心点可沿单个轴线对准,该轴线与支架移植物的纵向轴线大体平行。在其它实施例中,参见图1a,侧分支口110的多个远端114例如偏离一距离,该距离等于或大于侧分支口在其远端处的直径(假如尺寸不同的话,大于最大侧分支口远端的直径)。
在各示例性实施例中,如图1b最佳所示,侧分支口具有肘状构造116,从而其近端112定向成在支架移植物100内完全或局部顺行或逆行。实际上,发明人惊讶地发现,逆行灌注可与顺行灌注至少同样有效。
尽管“肘状构造”可对应于约90度的角度,但较大和较小的角度也可设想用于本发明。在一些实施例中,侧分支口110不是倾斜的;换言之,其近端和远端的中心点沿一共同轴线对准,该共同轴线例如是大体垂直于支架移植物的纵向轴线的轴线。
转到图1c-1d,在其它示例性实施例中,侧分支口110具有分叉构造(例如T形构造118),从而其近端112裂开且可定向成完全或局部顺行和逆行。换言之,近端112可具有多个不同开口,例如定向成完全或局部顺行的第一开口和定向成完全或局部逆行的第二开口。再者,可设想大于和小于约180度的角度,但在一示例性实施例中,近端之间的角度约为180度(即,两个近端面向相对方向)。在一个实施例中,一个或多个不倾斜的侧分支口110和/或具有T形构造118的侧分支口110位于具有肘状构造116的外部侧分支口110之间。
在一较佳实施例中,支架移植物包括具有肘状构造的侧分支口,侧分支口的两个近端对准在一平行的、共同或基本相似的平面上且面向彼此(例如,一个顺行而另一个逆行,一个相对于顺流成角度而另一个相对于逆流成对应角度)。重要的是,各示例性实施例中的近端可以是隔开的,例如根据待治疗分支血管的间隔。
而且,尽管近端的中心点可沿与支架移植物的纵向轴线大体平行的单个轴线对准,但各示例性实施例中的近端可例如偏离一距离,该距离等于或大于侧分支口自身在其近端处的直径(或者假如尺寸不同的话,大于最大侧分支口近端的直径)。例如,侧分支口包括延伸通过其近端中心点的纵向轴线。在各个实施例中,侧分支口的纵向轴线不是同轴的。在其它实施例中,侧分支口的纵向轴线是基本平行的。在还有其它实施例中,侧分支口的纵向轴线与支架移植物的纵向轴线大体平行。在还有其它实施例中,侧分支口的纵向轴线沿一共同平面大体对准。根据各示例性实施例,远端比近端在大致轴向上隔得更开。在还有其它实施例中,侧分支口的纵向轴线相对于彼此和/或支架移植物的纵向轴线歪斜。
在各个实施例中,近端可在一共同平面上或在多个平行的或倾斜的平面上对准,从而通过各侧分支口的近端存在大体畅通的通路。应能理解,该通路不一定需要与支架移植物的纵向轴线平行。在一实施例中,具有T形构造的一个或多个侧分支口插设在具有肘状构造的侧分支口之间。在这个实施例中,通过侧分支口近端的通路不一定需要是线性的。
一示例性系统包括如上所述具有至少两个侧分支口的支架移植物,该支架移植物挤压加载或以其它方式塌缩在管状元件上,且被套管保持或以其它方式容纳在套管中。
术语“管状元件”包括具有或不具有贯通腔的任何纵向延伸结构。因此,管状元件包括但不局限于有腔的管子、实心杆、空心或实心线(例如引导线)、空心或实心管针、金属管(例如海波管)、聚合物管、拉索或系绳、纤维、纤丝、电导线、辐射透不过元件、放射性元件和X射线照相的元件。管状元件可由任何材料制成,且可具有任何横截面形状,包括但不局限于以下型面:圆形、卵形、三角形、方形、多边形或任意形状。
套管可包括尼龙、聚碳酸酯、聚乙烯、聚丙烯、聚四氟乙烯、聚氯乙烯、聚氨酯、聚硅氧烷、不锈钢或其它生物相容材料中的一种或多种。在还有其它实施例中,套管是管状元件。
参见图2a-2b,在各示例性实施例中,支架移植物200被约束套管240挤压加载和约束,一个或多个管状元件220通过一些或全部侧分支口210,从而将管道保持通过其中(例如,用于分支线230的通路)。换言之,可保持一通过一些或全部侧分支口210的腔,该腔在支架移植物200保持被约束套管240约束时引导一引导线。在该实施例中,管状元件220可以穿过(通过)进入一个侧分支口210的远端214并退出其近端212,且进入另一侧分支口210的近端212并退出其远端214。在一些实施例中,管状元件额外地穿过具有T形构造的一个或多个侧分支口的近端。
在一实施例中,管状元件220的近端222和远端224延伸出侧分支口的两相对远端,且通过套管240离开支架移植物。通过套管的通路可通过各种构造来实现,包括但不局限于在套管中的适于管状元件通过的一个或多个狭缝242、孔、窗、空隙等。在一实施例中,狭缝242的对准被选定为防止套管240的撕裂。通路也可通过多个套管来实现,例如一中心套管和两个侧向套管。这里,管状元件220的近端222和远端224大体在中心套管和两个侧向套管之间的结合处延伸出侧分支口的两相对远端。
根据一实施例的一方面,管状元件220的远端224是封闭的以阻挡内部管状元件(例如引导线)的通过。以此方式限制内部管状元件通过侧分支口前进可有利于管状元件220移出受约束的支架移植物。远端可在各个实施例中通过热密封、或通过使用如附图标记226所示的端盖、塞子等来封闭。
其它示例性系统包括如上所述具有至少两个侧分支口的支架移植物、以及安装在该支架移植物近端处的一个或多个侧分支支架移植物和/或一个或多个延伸件。示例性的侧分支支架移植物可彼此独立或连接,如下文所述。示例性的延伸件包括动脉瘤和冠状动脉延伸件,这也将在下文进行描述。
现在将描述与该装置和系统使用有关的示例性方法,然而,它们不应被解释成限制本发明的范围,而仅是示例性的。
根据一个示例性方法,引导线使用现在已知或尚未知晓的技术从解剖入口(例如动脉或静脉中的窗口或开口)通过血管行进至位于治疗位置远侧的锚固位置。引导线的远端则再次使用现在已知或尚未知晓的方法、诸如气囊型导管锚固在锚固位置。
接着,如同本文所述的那样,具有至少两个侧分支口的支架移植物被挤压加载或以其它方式塌缩在管状元件上,且被套管保持或以其它方式容纳在套管内,沿引导线输送至治疗位置。
支架移植物的最佳定位可通过各种现在已知或尚未知晓的技术来确定。例如,辐射透不过的标记或标识可结合在支架移植物、侧分支口或管状元件中,从而有利于在血管内的定位和可视化。荧光镜可视化、造影注射和/或本领域已知的其它技术也可用于帮助定位支架移植物。
一旦在位,支架移植物就可通过套管而展开,此后一个或多个侧分支支架移植物可典型地通过待治疗的侧分支安装在侧分支口处。
现在将描述用于治疗升主动脉、主动脉弓和降主动脉疾病的示例性方法。参见图3,示出了升主动脉370、主动脉弓375和降主动脉380。继续参见图3,医师可诊断头臂动脉350、左颈总动脉355或左锁骨下动脉360的疾病。医师可实施单旁路365或双旁路365,且可希望用侧分支口将支架移植物展开在主动脉弓375中并治疗离开主动脉弓的每个祛病分支血管。
转到图4,根据一个示例性方法,使用现在已知或尚未知晓的技术将引导线435从股动脉中的切口通过主动脉行进至左心室。引导线435的远端则再次使用现在已知或尚未知晓的方法、诸如气囊型导管锚固在左心室内。
然后,使用现在已知或尚未知晓的技术将分支线430从待治疗分支血管(图4中的头臂动脉450)中的切口通过主动脉行进至股动脉中的切口。例如与包括位于具有肘状构造的外部侧分支口之间的、具有T形构造的一个或多个侧分支口的支架移植物有关,可使用一个以上的分支线430。这样,可治疗两个以上的分支血管。
接着,如同本文所述的那样,具有至少两个侧分支口(对应于离开主动脉弓的两个无疾病分支血管)的支架移植物被挤压加载或以其它方式塌缩在管状元件上,且被套管440保持或以其它方式容纳在套管440内。在各个实施例中且如上所述,侧分支口具有在一平行的、共同的或基本相似的平面上对准的且面向彼此的近端。侧分支口的近端和/或远端可如上所述偏离或不偏离。
支架移植物被挤压加载,管状元件通过侧分支口,从而保持供分支线通过侧分支口的通路。在包括位于具有肘状构造的外部侧分支口之间的、具有T形构造的一个或多个侧分支口的实施例中,一个以上的管状元件可通过支架移植物和侧分支口,从而保持供多条分支线通过侧分支口的多条通路。管状元件的近端和远端延伸出侧分支口的远端,且通过套管中的狭缝离开支架移植物。
当挤压加载的支架移植物沿引导线输送至主动脉弓时,分支线430经由管状元件穿过侧分支口。在一些实施例中,管状元件的远端可被盖帽,从而一旦分支线穿过,管状元件就被完全推出侧分支口和支架移植物。
参见图5a-5b,支架移植物500因此在其压缩构造中输送至主动脉弓575。如上所述,支架移植物的最佳定位可通过各种现在已知或尚未知晓的技术来确定。
一旦最佳定位,分支线530的延伸入股动脉的端部可被圈套出另一待治疗的分支血管(图5a中的左锁骨下动脉560)。为此可使用环形圈套或本领域现在已知或以后发现的任何其它圈套方法。在具有一个以上管状元件和一个以上分支线以用于治疗两个以上分支血管的实施例中,类似的圈套技术可用于对延伸出待治疗特定分支血管而延伸入股动脉的每个分支线530的端部进行圈套。
摩擦力可选地施加至分支线的端部以定位支架移植物,从而它“贴合”主动脉弓575的外曲率。
转到图5b,在示例性实施例中,然后通过移除套管来展开支架移植物。套管移除可通过各种现在已知或尚未知晓的方法来实现,诸如延伸通过股动脉入口的拉索。在一实施例中,支架移植物可通过简单地拆掉套管的缝线来展开。换言之,在一实施例中,可能不一定需要移除套管。
最后,一个或多个侧分支支架移植物590可安装在支架移植物500的侧分支口510处。暂时参见图6a,在一个实施例中,多个侧分支支架移植物590例如通过桥接件695彼此互连。
回到图5a-5b,在示例性实施例中,侧分支支架移植物590沿分支线530通过待治疗的侧分支血管550和560。参见图5b,必须小心以使侧分支支架移植物590不延伸超过旁路移植物591。侧分支支架移植物590可被挤压加载或以其它方式塌缩在管状元件上,且被套管保持或以其它方式容纳在套管内。侧分支支架移植物590可通过现在已知或尚未知晓的方法联接在侧分支口处,例如通过过盈配合、粘合、缝合、夹住等。
一个或多个延伸件可根据需要安装在支架移植物的近端和/或远端处。一般而言,延伸件可将支架移植物延伸成更靠近主动脉瓣根部且例如超过冠状动脉。类似于在本发明范围和精神内的支架移植物,延伸件可包括本领域现在已知或以后发现的材料,例如镍钛诺螺旋或环结构和一个或多个ePTFE覆盖物。其它有用的材料可包括尼龙、聚碳酸酯、聚乙烯、聚丙烯、聚四氟乙烯、聚氯乙烯、聚氨酯、聚硅氧烷、不锈钢或其它生物相容材料。
延伸件可在支架移植物腔径向扩张之后、在沿引导线插入或前进通过支架移植物腔之前连接至支架移植物。示例性的延伸件包括动脉瘤和冠状动脉延伸件,分别如图6b和6c所示。
一示例性的动脉瘤延伸件可包括径向刚硬部分692和径向顺应部分693,该径向顺应部分693具有渐增的截头锥型直径,且构造成以最小的力密封。
一示例性的冠状动脉延伸件可包括在另一冠状动脉延伸件内的一个冠状动脉延伸件。一示例性的冠状动脉延伸件可包括安装在一个或多个冠状动脉中的一个或多个侧分支支架移植物694。在包括冠状动脉延伸件的实施例中,引导线可插入冠状动脉以引导延伸件的定位。
对于本领域技术人员来说明显的是,可在本发明内作出各种修改和变型而不脱离本发明的精神和范围。因此,本发明旨在覆盖本发明的修改和变型,只要它们落入所附权利要求书及其等同物的范围内。

Claims (21)

1.一种用于治疗血管疾病的系统,所述系统包括:
导管;
支架移植物,所述支架移植物具有至少两个侧分支口,每个侧分支口具有近端和远端,各所述远端与所述支架移植物的外表面基本邻接,所述远端在大体轴向上比所述近端隔得更开;
约束套管,用于将所述支架移植物约束到所述导管的端部上以在腔内输送所述支架移植物;以及
引导线管,所述引导线管延伸通过所述至少两个侧分支口且保持一腔,当所述支架移植物保持被所述约束套管约束时,所述引导线管的所述腔将引导线引导通过所述至少两个侧分支口,其中,所述引导线管的一端封闭以限制所述引导线通过所述侧分支口,同时所述引导线管延伸通过受约束的支架移植物的所述至少两个侧分支口。
2.如权利要求1所述的系统,其特征在于,每个侧分支口包括延伸通过其相应近端的中心点的纵向轴线。
3.如权利要求2所述的系统,其特征在于,所述侧分支口的纵向轴线不是同轴的。
4.如权利要求3所述的系统,其特征在于,所述侧分支口的纵向轴线基本平行。
5.如权利要求2所述的系统,其特征在于,所述侧分支口的纵向轴线沿一共同平面大体对准。
6.如权利要求1所述的系统,其特征在于,至少一个近端面向顺行。
7.如权利要求1所述的系统,其特征在于,至少一个近端面向逆行。
8.如权利要求1所述的系统,其特征在于,所述近端中的一个近端面向顺行,所述近端中的另一近端面向逆行。
9.如权利要求1所述的系统,其特征在于,至少一个侧分支口包括分叉构造。
10.如权利要求9所述的系统,其特征在于,具有分叉构造的所述侧分支口是大体T形的。
11.如权利要求1所述的系统,其特征在于,包括第三侧分支口,所述第三侧分支口具有T形构造且设置在所述至少两个侧分支口的近端之间。
12.如权利要求11所述的系统,其特征在于,至少两个侧分支口是大体肘状的。
13.如权利要求1所述的系统,其特征在于,至少一个侧分支口是大体肘状的。
14.如权利要求3所述的系统,其特征在于,所述侧分支口的纵向轴线与支架移植物的纵向轴线大体平行。
15.如权利要求1所述的系统,其特征在于,所述引导线管可在所述引导线被接纳通过其中之后移除。
16.如权利要求1所述的系统,其特征在于,所述引导线管的相对两端通过所述约束套管中的不同狭缝而延伸离开所述支架移植物。
17.如权利要求1所述的系统,其特征在于,还包括安装在所述至少两个侧分支口处的一个或多个侧分支支架移植物。
18.如权利要求1所述的系统,其特征在于,还包括至少一个侧分支支架移植物,所述侧分支支架移植物延伸通过所述侧分支口中的至少一个侧分支口以治疗分支血管。
19.如权利要求1所述的系统,其特征在于,还包括至少两个侧分支支架移植物,所述至少两个侧分支支架移植物分别延伸通过所述至少两个侧分支口。
20.如权利要求19所述的系统,其特征在于,所述至少两个侧分支支架移植物中的两个是互连的。
21.如权利要求1所述的系统,其特征在于,还包括安装在所述支架移植物的近端处的延伸件。
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