CN103717178B - 用于将医疗装置递送到心脏瓣膜的装置和方法 - Google Patents

用于将医疗装置递送到心脏瓣膜的装置和方法 Download PDF

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CN103717178B
CN103717178B CN201280022255.7A CN201280022255A CN103717178B CN 103717178 B CN103717178 B CN 103717178B CN 201280022255 A CN201280022255 A CN 201280022255A CN 103717178 B CN103717178 B CN 103717178B
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E.克拉比奇勒
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Abstract

本发明公开了一种用于将医疗装置经血管递送到患者的心脏瓣膜区域的导管装置(1)。所述导管装置包括：细长套管(2)，其具有管腔和用于定位在心脏瓣膜(6)处的远端(3)；以及第二通道(7)，其平行于所述细长套管或在所述细长套管中延伸；可膨胀的栓子保护单元(8)，例如，过滤器，其中可膨胀的栓子保护单元的至少一部分布置成从第二通道的孔口延伸，其中栓子保护单元为非管状的，在膨胀状态下大致平坦地延伸以便覆盖主动脉弓中的侧支血管的开口。

Description

用于将医疗装置递送到心脏瓣膜的装置和方法
技术领域
本发明大体上涉及医疗装置的领域。特别地，本发明涉及用于递送医疗装置的导管的定位和程序，并且更具体而言，涉及医疗装置向心脏瓣膜的经血管递送。 
背景技术
人体心脏是一个中空的肌肉器官，负责每日将大量血液泵送到人体各处。泵送血液的能力通过若干心脏瓣膜来促进，这些瓣膜适当地打开和关闭以允许血液通过心脏。由于先天性缺陷或增加的心脏病发病率导致的心脏瓣膜功能不全常常需要治疗功能不全的瓣膜，其中主要治疗方式是机械调整瓣膜或完全置换瓣膜。现有医学技术意图从对患者创伤严重的开放式心外科大手术转向更微创的基于导管的手术，后者是创伤更轻、但更复杂的手术。 
基于导管的手术需要将用来递送例如置换瓣膜的导管相对于待治疗的心脏瓣膜精确定位在最佳位置。当不对准有可能损害相邻的心脏结构，导致严重的冠状动脉并发症时，这一点尤其重要。心脏在整个手术过程中继续泵送，产生导管必须克服以保持其位置的显著的湍流水平，这一事实妨碍了导管邻近心脏瓣膜的置入。此外，导致栓子的血液的凝固是一个持续的威胁，因为它潜在地会导致诸如中风的严重并发症。 
在美国专利申请2009/0030510A1中，公开了置换主动脉瓣的重大障碍是用于置换主动脉瓣的医疗装置的准确置入。所教导的对该问题的解决方案是临时主动脉瓣(TAV)装置。这是一种在远端具有多个球囊的导管，球囊可被充气以通过将压力直接施加到患者的主动脉壁而稳定TAV的位置。此外，瓣膜调节工具可穿过TAV的管腔。血液被允许穿过球囊之间，以模拟主动脉瓣功能。该装置设计用于主动脉瓣的消融和置换，其中TAV的球囊在整个手术过程中被充气以有利于抵靠动脉壁存放。 
球囊在整个医疗手术过程中被充气。由于球囊通过限制用于主动脉腔的血流的可用横截面而妨碍血流，潜在地导致引起许多不期望的问题。例如，在手术期间的可递送血量可减少，对患者具有潜在的可怕后果。在由充气的球囊形成的限制的上游处，血压可能增加。球囊在主动脉腔中长时间充气时，例如由于其上游增加的血压而可能脱位。 
WO 2006/029370和US 2009/0287182公开了可膨胀的经腔套管。套管的远端在穿过房间隔推进到左心房期间保持在第一低横截面构型。套管的远端使用径向扩张器(dialator)(球囊)膨胀以扩张房间隔的组织中的洞。问题在于，该装置对于牢固定位来说不足够稳定。径向膨胀仅仅是为了允许洞更彻底地愈合，而不是从一开始就切割一个大洞。 
US2005/0085842公开了一种可膨胀的导向套管。该套管在收缩状态下被推进到血管中，膨胀至扩大状态以限定管腔。膨胀的管腔用于递送流体或器械。同样，在该现有技术中，问题在于，装置对于牢固定位来说不足够稳定。过滤器公开为箍的形式。箍的框架设置成与血管周向并置(apposition)，以便收集在血管中输送的栓子。 
US2003/0171803公开了一种类似的箍形过滤篮，其中箍的框架设置成与血管壁周向接触。 
US 2006/074484 A1公开了用于经血管内、心内或腔内路径到达患者心脏的方法和系统。该专利公开了用于置入冠状窦中的栓子保护装置。导线终止于冠状窦处并在胸廓切开术进入部位离开患者，并且可在顺行方向上沿导线插入新瓣膜。
WO 2011/132080 A2公开了一种瓣膜成形术导管，其通过导向导管引入，直到球囊元件横跨主动脉瓣定位为止。导向导管的远端采用管状栓子过滤元件，其通过外套管提供的约束而约束在收缩构型。该专利还公开了施加到主动脉支路附近的上主动脉壁的另一种栓子偏转网。
US 2008/147160 A1公开了一种用于将心脏瓣膜假体定位在血管中的器械，其包括朝植入部位可滑动地引导瓣膜假体的线元件和联接到线元件的可膨胀元件。可膨胀元件可在血管中膨胀以相对于植入部位定位线元件。
WO 2005/023358 A1公开了用于在进入患者脉管系统内的血管过程中提供远端保护的设备和方法。柔性的套管和远端保护元件例如球囊或过滤器由导管承载。鞘管可位于远端区域或者可沿导管的整个长度延伸。
US 2010/211095 A1公开了一种通过肱动脉或挠动脉路径部署到主动脉中以覆盖头肱动脉和左侧颈总动脉的口的栓子偏转器。
因此，用于在心脏瓣膜置换期间稳定导引器套管的改进的或备选的医疗装置和程序将是有利的，特别地赋予增加的性价比和/或患者安全。 
发明内容
因此，本发明的实施例优选地试图通过提供根据本发明的所附专利权利要求的医疗装置和方法而单独地或以任何组合减轻、缓解或消除诸如以上提及的本领域中的一个或多个缺陷、缺点或问题。 
本发明是带有栓子保护单元的导引器套管，该保护单元保护主动脉弓的侧支血管以减小栓塞风险，防止受例如来自狭窄瓣膜的处理的碎屑的影响，同时允许将套管定位在心脏瓣膜处并穿过其中递送医疗装置。此外，导引器套管通过使用锁定导管以将其保持在期望的解剖位置的锁定系统来克服现有导管面临的定位问题。除了保持位置之外，本发明设计成使得对血流的妨碍最小。 
根据第一方面，提供了用于将医疗装置经血管递送至患者的心脏瓣膜区域的导管装置。该导管装置包括：细长套管，其具有管腔和用于定位在心脏瓣膜处的远端；以及第二通道，其平行于所述细长套管或在所述细长套管中延伸；可膨胀的栓子保护单元，例如过滤器，其中可膨胀的栓子保护单元的至少一部分布置成从第二通道的孔口延伸，其中栓子保护单元为非管状的，在膨胀状态下大致平坦地延伸以便覆盖主动脉弓中的侧支血管的开口。 
在第二方面，提供了一种将医疗装置经血管递送至患者的心脏瓣膜的方法。该方法包括：提供包括处于松弛状态的具有管腔的细长套管的导管并将该导管微创地导引至所述脉管系统中；将所述细长套管的远端通过所述脉管系统导航至所述心脏瓣膜；使来自所述套管中的第二通道的栓子保护单元膨胀以覆盖主动脉弓中的侧支血管的开口并使所述套管的远端稳定在心脏瓣膜处； 
在所述栓子保护单元覆盖所述开口的同时将医疗装置通过所述锁定的细长套管的管腔递送至所述心脏瓣膜。
本发明的另外的实施例在从属权利要求中限定，其中用于本发明的第二方面和后续方面的特征已对第一方面做出必要的修正。 
应当强调的是，术语“包括/包含”当在本说明书中使用时用来规定所述特征、整数、步骤或部件的存在，但不排除一个或多个其它特征、整数、步骤、部件或它们的组的存在或添加。 
附图说明
参照附图，根据对本发明的实施例的以下描述，本发明的实施例能够实现的这些和其它方面、特征和优点将显而易见并能得到阐明，在附图中： 
图1A是连接到止血阀的细长套管的示意图；
图1B是具有处于收缩构型的径向可膨胀单元的细长构件的示意图；
图2A是具有处于收缩构型的径向可膨胀单元的细长构件的远端部分的示意图；
图2B是具有处于膨胀构型的径向可膨胀单元的细长构件的远端部分的示意图；
图2C是具有处于收缩构型的径向可膨胀单元的细长构件的远端部分的示意性前视图；
图2D是具有处于膨胀构型的径向可膨胀单元的细长构件的远端部分的示意性前视图；
图3A、图3B、图3C、图3D是处于柔性解锁构型的细长套管的实施例的示意图；
图3E是处于解锁状态的细长套管的剖视图的示意图；
图3F是处于锁定状态的细长套管的剖视图的一个实施例的示意图；
图3G是处于锁定状态的细长套管的剖视图的另一个实施例的示意图；
图4A是经腋路(transaxillary)递送至心脏瓣膜的细长套管的示意图，其中栓子保护过滤器被部署，并且套管处于松弛状态；
图4B是示意图，其中松弛的套管由在套管的远端外部延伸的细长构件的可膨胀单元相对于心脏瓣膜定位；
图4C是采用用于递送栓子保护过滤器的第二通道的细长套管的剖视图的示意图；
图4D是经腋路递送至心脏瓣膜的细长套管的示意图，并且套管处于相对于主动脉心脏瓣膜布置的锁定构型，并且可膨胀单元在定位套管之后被撤出；
图4E是经股动脉(transfemorally)递送至心脏瓣膜的细长套管的示意图，其中栓子保护过滤器被部署并且套管处于锁定构型；
图4F是经腋路递送至心脏瓣膜的细长套管的示意图，并且其中松弛的套管通过套管的可膨胀单元相对于心脏瓣膜定位；
图4G是经腋路递送至心脏瓣膜的细长套管的示意图，并且其中栓子保护过滤器经由套管的第二通道部署在主动脉弓中的血管上；
图4H是经股动脉递送至心脏瓣膜的细长套管的示意图，并且其中栓子保护过滤器经由套管的第二通道部署在主动脉弓中的血管上；以及
图5是植入医疗装置的方法的流程图。
具体实施方式
现在将参照附图描述本发明的具体实施例。然而，本发明可以以许多不同的形式具体化并且不应理解为局限于本文中所阐述的实施例；相反，提供这些实施例是为了使本公开变得全面而完整，并且将本发明的范围完整地传达给本领域的技术人员。附图中所示实施例的详细描述中所使用的术语并非意图限制本发明。在附图中，类似的数字表示类似的元件。 
在根据图1A的本发明的实施例中，示出了用于将医疗装置经血管递送至患者的心脏瓣膜区域6(参见例如图4D)的导管装置1。导管装置包括具有管腔和远端3的细长套管2。此外，在图1B中，细长构件4设有包括多个径向可膨胀单元5的远端部分9。端部9可包括闭塞物。可膨胀单元5布置用于将细长套管2相对于心脏瓣膜6临时定位，参见图4B和图4F。细长构件4能够可回缩地插入细长套管2的管腔中，并且细长套管2包括可释放的锁定构件，以用于在由可膨胀单元5相对于心脏瓣膜6定位时将细长套管2至少部分地沿其长度从松弛状态(参见图3B和图4A-B、图4F)到锁定状态(参见图3C-D和图4D-E、图4G-H)可控制地锁定形状。 
图1A中描绘的细长套管2设计成能够在松弛状态下经血管递送，这有利于在输送经过脉管系统时最佳的柔韧性。当处于期望的解剖位置时，细长套管2在由所述可膨胀单元5相对于心脏瓣膜6定位时(如图4D-E中可见)能够通过锁定构件的促动从松弛状态转变到锁定状态，这有利于导管1的最佳稳定，以便随后将医疗装置固定到心脏瓣膜6。 
图4A示出以其松弛形状插入的细长套管。图4B示出处于其膨胀构型(即，在细长套管2外部)的径向可膨胀单元5，其将细长套管2居中地定位在瓣膜6上方。可膨胀单元5在细长构件4外部膨胀，细长构件4延伸超出套管2的远端。然后，细长套管2通过锁定构件而处于其锁定状态，并且细长构件4可与收缩的多个径向可膨胀单元5一起从细长套管2的管腔回缩，如在图4D-E中可见。套管2此时定位和稳定在瓣膜6上方。这克服了现有技术中不够稳定和精确定位缺乏的问题。仅仅提供可膨胀的导管不能提供像套管2的锁定构件那样的稳定性。可膨胀导管具有另一个用途，即，提供可进入的管腔或使隔膜穿孔扩张。此外，先前导管的可膨胀构件仅用于提供上述膨胀，而不用于像导管1所提供的那样将导管居中定位在瓣膜的上方。当细长套管2被锁定并且当细长构件4回缩时，细长套管2的管腔是可进入的，以用于将医疗装置递送至心脏瓣膜6区域。 
备选地或此外，诸如球囊的可膨胀单元可布置在套管2的外部上。可膨胀单元可与套管一体地形成，如在图4F中可见。因此，可膨胀单元不影响套管2的管腔的横截面。在返回到未膨胀状态时，例如通过将可膨胀单元5的球囊放气，可实现医疗装置穿过导管管腔的递送，而不需要回缩可膨胀单元5。 
可膨胀单元允许将导管套管2的远端相对于心脏瓣膜限定地定位在诸如血管、心房或心腔的解剖结构中。这使得可通过导管装置精确递送医疗装置。某些解剖结构的移动在心脏循环期间是非常有限的。例如，主动脉弓是相对稳定的，并且锁定的导管将大致保持在相同的空间取向、方向和到心脏瓣膜的距离，就像在由膨胀的可膨胀单元5提供的最终定位期间那样。 
导管可因此相对于心脏瓣膜定位在解剖结构中。 
导管可沿其整个长度锁定在锁定构型。备选地，导管可仅沿其远端部分锁定。远端部分可例如是布置在升主动脉、主动脉弓和降主动脉中的部分，如在图4E中所示。导管可包括栓子保护单元8，例如栓子保护过滤器8。在突出到第二管腔7之外并且抵靠周围血管壁并置时，栓子保护单元8还可有助于将锁定的导管的远端相对于心脏瓣膜稳定到位。因此，当栓子保护单元8膨胀时，它将用作对套管的锚具，因为它因第二通道7固定到套管而防止套管2在主动脉弓中移动，其中栓子保护单元从第二通道7膨胀。用于栓子保护单元8的递送单元13具有足够的刚度，以赋予套管2的锚固功能。栓子保护单元8提供套管2的稳定化和锚固，而不论套管2是否处于松弛状态或锁定状态。此外，栓子保护单元8提供套管2的稳定化和锚固，而不论是否使用可膨胀单元5。因此，套管2不一定具有锁定构件、细长构件4或可膨胀单元5，以便提供所述的有利效果，进一步参见下文。 
图4D是经腋路递送至心脏瓣膜(这里为主动脉瓣6)的细长套管的示意图。栓子保护过滤器8被部署，并且套管2处于相对于主动脉心脏瓣膜6布置的锁定构型。 
图4E是经股动脉递送至心脏瓣膜的细长套管的示意图，其中栓子保护过滤器被部署并且套管处于锁定构型。 
在图4D和图4E中，未示出可膨胀单元5，因为它们或者从套管回缩，或者返回至其在套管中的不引人注意的未膨胀/收缩构型。 
在图4G-H中，栓子保护过滤器8分别定位在主动脉弓中的两个或三个血管上。 
在图4A-B、图4D-H所示的所有构型中，侧血管22被有效地保护以免栓子颗粒从主动脉弓进入。栓子颗粒随血流越过栓子保护装置沿主动脉弓携带至比侧血管22中的一些将血流导向至的部位(例如脑部)更不敏感的解剖结构。栓子保护单元可以是在其中捕集栓子颗粒的过滤器单元。备选地或此外，栓子保护单元可使颗粒沿保护单元滑动，但不穿过保护单元或紧固在其中。 
在诸如图4A-H中所示的实施例中，描绘了具有第二通道7的导管1，第二通道7在细长套管2的外部或内部上平行延伸。当细长套管2的管腔用于细长构件4或医疗装置时，该通道7允许递送另外的单元例如栓子保护装置8或液体以辅助用于置入医疗装置的手术。 
第二通道7可以是在细长套管2的内部或外部上的一体部分。这具有通过挤出方法相对廉价地制造的优点。 
在图4A-H中，描绘了可膨胀的栓子过滤器8实施例。栓子保护或过滤装置8可在延伸上述可膨胀单元5之前延伸。这潜在地通过捕获诸如由狭窄的瓣膜的处理产生的血小板碎屑的任何栓子而增强患者安全，且从而减小诸如中风的严重并发症的可能。在这些图中，可膨胀栓子过滤器8的至少一部分从栓子过滤器8所经过的侧通道7的孔口延伸。栓子过滤器可以是WO 2010/026240中所公开的类型，该专利全文以引用方式并入本文以用于各种目的。栓子过滤器单元可以是非管状的，且在膨胀状态下大致平坦地延伸。这提供了紧凑的装置并有效地阻止栓子进入主动脉弓中的侧支血管。与主动脉弓中的侧壁的相互作用因此也保持最少，从而避免刮擦掉将在血流中输送的更多碎屑。同时，主动脉弓保持开放以用于套管2的无阻碍导航。在先前的装置中的箍形篮刮擦血管壁并阻塞主动脉弓中的相当大一部分导航空间。 
在此上下文中，“平坦地”延伸意味着装置的厚度显著小于其纵向延伸。此外，“平坦”是指垂直于保护材料纵向延伸的如下的尺寸，即使得通过主动脉弓的血流不受保护装置阻碍。 
通过在套管2中具有第二通道，套管的远端可通过从第二通道延伸的保护单元8的稳定和锚固效应而适当地定位在瓣膜处，同时医疗装置可递送通过套管的管腔而不受保护单元8或例如诸如球囊的可膨胀单元的任何阻碍，同时保护主动脉弓的侧支血管不受由在瓣膜处进行的手术产生的可能在血流中输送的栓子的影响。 
导管装置1可包括能够在连接点14处连接到栓子过滤器单元8的递送单元13，如在图4G-H中所示。连接点14在栓子过滤器单元处偏心布置，使得递送单元13可偏心连接到栓子过滤器单元8。栓子过滤器单元的偏心定位对于利用套管2通过递送单元13部署它来说是有利的，同时在进行介入时有效地保护颈动脉不受栓子的影响。血流通过这样紧凑的装置而有效地保持畅通。在本申请的上下文中使用的术语“偏心”意味着不在正中间或者不布置或定位在中心处。中心是例如圆形单元的中心、椭圆形单元的焦点、诸如细长单元的纵向中心线的中心线上的点等。单元的周边“偏心”定位，因为它布置在相对于单元中心的一定距离处。 
细长构件4可由等间距地围绕纵向轴线径向定位的三个球囊构成(参见图2C和图2D)。可以是更少或更多的球囊，以及诸如可膨胀机械杠杆的备选膨胀单元，或诸如可回缩海绵的溶胀单元。膨胀单元5允许细长套管2相对于上述心脏瓣膜6的最佳定位。多球囊膨胀单元可使用各种装置膨胀(参见图2D)，例如使用流体装置或在适当时气体装置。球囊也可单独地或同时膨胀以及充气至不同压力，而与其它膨胀单元无关。 
备选地，细长构件4可回缩地插入细长套管2管腔内一定长度，该长度等于在远端9和第二近端标记物10之间的距离。在该实施例中，近端标记物10和11用来引导远端部分9的定位取向并因此提供可膨胀单元5与待膨胀的细长套管2的部分的最佳对齐。这有利于安全定位在期望的瓣膜区域处。 
在另一个实施例中，细长套管2由射线不可透材料构成，有利于细长套管2的可视化，这提供了细长套管2的最佳定位以便递送医疗装置。备选地，在细长套管2上的射线不可透的基准标记物可用于套管2在患者体内的最佳定位。 
图2A和图2B中所示实施例包括导线12，导线12首先定位在患者体内，这有利于细长套管2和细长构件4向期望的解剖部位的最佳输送。 
在图3-4的实施例中，锁定单元可包括可释放的闩锁，但可想到任何一种形式的拉线、挤压机构等，其用来将细长套管2锁定在锁定状态，即，套管的刚性或半刚性状态，该状态允许套管2保持特定曲率，即，减小柔韧性，且从而固定其相对于解剖结构的位置，参见例如图4D-E。此外，锁定单元或细长套管2自身的材料的热学、电学、磁性或化学性质可提供变化的柔韧性，以便在锁定状态和松弛状态之间改变。 
在具体实施例中，细长套管在处于锁定构型时可膨胀。当细长套管2处于膨胀状态时，锁定单元的释放将细长套管2锁定在膨胀状态，并因此保持通过手术定位的医疗装置的最佳位置。 
锁定的细长套管2可在医疗过程中用来将医疗装置递送至心脏瓣膜6，医疗装置可包括人造心脏瓣膜假体、瓣环成形装置或二尖瓣夹。 
细长套管2可以是设计用于将医疗装置经血管递送至患者的心脏瓣膜6的医疗系统的组成部分。图5中所描绘的方法首先包括100将包括处于松弛状态的具有管腔的细长套管2的导管1经股动脉(参见图4E)或经腋路(参见图4D)微创地导引至患者的脉管系统中。步骤110涉及将所述细长套管2的远端3通过脉管系统导航至期望的心脏瓣膜，参见图4A。在系统中的下一步骤120涉及将具有包括多个径向可膨胀单元5的远端部分9的细长构件4插入细长套管2的管腔中，此后，细长构件4穿过细长套管2推进至细长套管2的远端，参见图4B。 
备选地，套管的可膨胀单元5可在该阶段膨胀(而不将细长构件4引入套管中，参见图4F)。此后，开始步骤130，该步骤涉及多个径向可膨胀单元5，其径向膨胀以相对于心脏瓣膜6临时定位细长套管2(参见图4B和图4F)。 
在定位之后，导管的锁定构件被释放以将细长套管2保持在锁定状态(步骤140)。然后可进行该系统的步骤150，其中可膨胀单元5接着回缩，并且将细长构件4从细长套管2的管腔撤出，参见图4D-E。备选地，套管2的可膨胀单元5返回到未膨胀状态。 
如图4A-H所示，栓子保护单元可接着被推出第二通道7。这样，侧血管受到针对诸如碎屑的栓塞材料的保护。 
现在可将医疗装置通过锁定的细长套管2的管腔递送至心脏瓣膜6。这种递送以高的空间精度进行。在锁定的套管2周围的管腔中的血流受到的影响比用膨胀的可膨胀单元5时少。 
医疗装置可例如是心脏瓣膜修复或置换装置。 
当医疗装置已递送，现在可进行锁定构件的释放以使细长套管2返回到松弛状态(步骤160)，随后将处于松弛状态的细长套管2从患者的脉管系统中撤出。 
如图4A-H中所示的栓子保护单元可在锁定构件释放之前或之后回缩。 
将细长套管2锁定在锁定状态(图3B-D)包括当由可膨胀单元5相对于心脏瓣膜6定位时释放锁定构件以便可控制地锁定细长套管2。这用来在手术期间为医疗装置的递送保持最佳位置。 
为了确保细长构件4在被插入细长套管2时的最佳定位，细长构件4被插入到等于在细长构件4的远端和近端标记物10之间的距离的长度。首要地，细长套管2将相对于心脏瓣膜6居中地定位，这有利于医疗装置的最佳递送，但其它偏心位置也是可取的。 
医疗系统主要用于递送将固定到特定心脏瓣膜6的医疗装置，这包括患者的主动脉瓣和二尖瓣。在将医疗装置递送到心脏瓣膜6之后，医疗装置递送系统被通过锁定的细长套管2的管腔撤出，这在细长套管2处于膨胀状态时可在辅助下进行。在移除医疗装置递送系统之后，处于所述锁定状态的细长套管2转移到所述松弛状态，这有利于促进细长套管2的回缩。 
上面已参照具体实施例描述了本发明。然而，除了上述之外的其它实施例同样可能地在本发明的范围内。在本发明的范围内可提供与以上所述不同的方法步骤。本发明的不同特征和步骤可除以上所述之外的其它组合结合。导管可定位和锁定在除图示之外的其它心脏解剖结构中。通过导管套管递送的医疗装置可以是将递送到心脏瓣膜组织的任何医疗装置。本发明的范围仅受所附权利要求的限制。 

Claims (17)

1.一种用于将医疗装置经血管递送到患者的心脏瓣膜区域的导管装置，所述导管装置包括：
细长套管，其具有管腔和用于定位在心脏瓣膜处的远端，以及
通道，其平行于所述细长套管或在所述细长套管中延伸；
可膨胀的栓子保护单元，其中，所述可膨胀的栓子保护单元的至少一部分布置成从所述通道的孔口延伸，其中，所述栓子保护单元为非管状的，在所述膨胀状态下大致平坦地延伸以便覆盖主动脉弓中的侧支血管的开口，其中，所述栓子保护单元布置成当所述栓子保护单元膨胀出所述通道时稳定所述套管的所述远端。
2.根据权利要求1所述的导管装置，其特征在于，包括可在连接点处连接到所述栓子保护单元的递送单元，其中，所述连接点偏心布置在所述栓子保护单元处，使得所述递送单元可偏心连接到所述栓子保护单元。
3.根据权利要求1所述的导管装置，其特征在于，所述栓子保护单元在处于膨胀状态时用作对所述套管的锚具。
4.根据权利要求1所述的导管装置，其特征在于，包括多个径向可膨胀单元，所述多个径向可膨胀单元布置用于在处于膨胀状态时将所述细长套管相对于所述心脏瓣膜临时定位；以及
其中，所述细长套管包括可释放的锁定构件，以用于在由所述径向可膨胀单元相对于所述心脏瓣膜定位时将所述细长套管至少部分地沿其长度从松弛状态到锁定状态可控制地锁定形状，以便稳定所述细长套管。
5.根据权利要求4所述的导管装置，其特征在于，包括具有包括所述多个径向可膨胀单元的远端部分的细长构件，其中，所述细长构件能够可回缩地插入所述管腔内。
6.根据权利要求5所述的导管装置，其特征在于，所述细长套管能在所述松弛状态下经血管递送以便在由所述径向可膨胀单元相对于所述心脏瓣膜定位时从所述松弛状态转变到所述锁定状态，并且其中，所述细长构件在收缩时可与所述多个径向可膨胀单元一起从所述管腔回缩以便锁定所述细长套管，并且当所述细长构件回缩时，所述管腔可进入以用于所述医疗装置向所述心脏瓣膜区域的所述递送。
7.根据权利要求1所述的导管装置，其特征在于，所述通道固定或一体化在所述细长套管的外部上；或者其中，所述通道固定或一体化在所述细长套管的内部上。
8.根据权利要求5所述的导管装置，其特征在于，所述多个径向可膨胀单元包括可膨胀球囊。
9.根据权利要求5所述的导管装置，其特征在于，所述多个径向可膨胀单元包括可回缩到所述套管中的可膨胀的机械杠杆或可溶胀单元。
10.根据权利要求5所述的导管装置，其特征在于，所述细长构件可回缩地插入所述细长套管的管腔中一定长度处，所述长度等于在所述远端和近端标记物之间的距离。
11.根据权利要求1所述的导管装置，其特征在于，所述细长套管包括射线不可透的基准标记物。
12.根据权利要求4所述的导管装置，其特征在于，所述锁定构件由拉线、可释放闩锁或挤压机构构成。
13.根据权利要求1所述的导管装置，其特征在于，所述医疗装置为人造置换瓣膜或瓣膜修复装置。
14.根据权利要求1-13中的任一项所述的导管装置，其特征在于，所述心脏瓣膜为所述患者的主动脉瓣或所述患者的二尖瓣。
15.根据权利要求8所述的导管装置，其特征在于，所述多个径向可膨胀单元包括围绕所述细长套管的纵向轴线等间距地径向定位的三个球囊。
16.根据权利要求13所述的导管装置，其特征在于，所述医疗装置为瓣环成形术植入物。
17.一种用于心脏瓣膜的根据权利要求1-16中的任一项所述的导管装置和医疗装置的套件。
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