CN101128168A - 用于穿过血管而植入心脏瓣膜假体的导管 - Google Patents

用于穿过血管而植入心脏瓣膜假体的导管 Download PDF

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CN101128168A
CN101128168A CNA200680002672XA CN200680002672A CN101128168A CN 101128168 A CN101128168 A CN 101128168A CN A200680002672X A CNA200680002672X A CN A200680002672XA CN 200680002672 A CN200680002672 A CN 200680002672A CN 101128168 A CN101128168 A CN 101128168A
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H·-R·菲古拉
M·弗拉里
R·奥特马
R·莫茨纳
C·达姆
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Abstract

本发明涉及一种用于穿过血管而植入尤其是带有自扩展式锚固支架(10)的心脏瓣膜假体的导管，这种导管允许以最小侵袭性的方式而植入心脏瓣膜假体。本发明的目的是降低植入过程中对病人的风险。为了实现这一目的，根据本发明，将包括锚固支架的心脏瓣膜假体在所述植入的过程中以折叠的形式而暂时地容纳在储筒单元(4)内。这种储筒单元可固定在引导系统(1)的近端上，所述引导系统具有能够穿过主动脉的可弯曲区域(9)。操作元件(2，3)延伸穿过中空的引导系统的内部，这些操作元件允许储筒单元的部件围绕其纵轴线而沿径向地移动和/或在近侧方向上移动，从而允许锚固支架的单个部件和所述心脏瓣膜假体一起顺序地释放开。

Description

用于穿过血管而植入心脏瓣膜假体的导管
技术领域
本发明涉及带有自扩展式锚固系统的用于穿过血管而植入心脏瓣膜假体的导管，心脏瓣膜假体可通过这种导管而以最小侵袭性的方式植入体内。
背景技术
已经变得越来越常见的是，越来越多的病人需要植入心脏瓣膜假体，为此，使用人造的和生物的植入体来用于心脏瓣膜假体。
在过去，这类手术必须对麻醉的病人使用心肺机。因此，这就使得它成为一项成本高昂的外科手术，这就使得病人承受高度的心理紧张和身体紧张。目标是保持致死率在3％以下。随着相应病人年龄的增长和各自心脏瓣膜的受损越来越提前，就会达到其中需要实际治疗的病人不能做手术的情形。由于手术瓣膜更换对于这些病人是不可能的，因此他们的生活质量会下降，并且期望寿命会大大缩短。手术将要冒极大的风险。
这些同样的问题也适用于通过所谓的气囊导管来植入带锚固系统的心脏瓣膜假体的手术。
在这种类型的手术程序中，可能出现不正确的定位，这就可能对病人有很大的影响，从而可能导致相应病人的死亡。
因此，最近以来，已经尝试通过涉及最小侵袭性的手术干预方法来来植入心脏瓣膜假体，其中，这种假体就连同锚固支架一起经由病人的主动脉植入病人体内，并且穿过主动脉而到达心脏。在到达心脏的植入部位后，就起动这种锚固支架的自扩展，其中心脏瓣膜假体连在锚固支架上，预期的结果是实现心脏瓣膜假体的可靠锚固和精确定位。这种锚固支架倾向于由形状记忆合金如“镍钛合金”制成，并且这种合金被选择成使得其转变温度为大约37℃，并且自扩展可在达到转变温度时起动。
作为这种扩展的结果，锚固支架展开，使得它能够贴靠在主动脉壁上，其中，锚固支架可在必要时通过另外的倒钩元件而牢固地固定。心脏瓣膜假体同时展开，使得它能够承担其功能。
这种类型的结合有心脏瓣膜假体的锚固支架例如在专利说明书WO 2004/019825 A1中进行了介绍。
支架环设置在这种锚固支架的近端，并且可被引入病人的心脏瓣膜的腔穴中，从而使得锚固支架在手术干预过程中通过这些支架环而得以非常精确地定位。另外，所称的连合环设置在该锚固支架上，一旦锚固支架展开，该连合环就连同支架环一起夹紧病人的老的心脏瓣膜，以便锚固支架可由于这种夹紧效应而可靠地定位和固定。
因此，这种已知锚固支架的支架环和连合环应布置成并且在尺寸上设置成使得这类支架环和连合环允许按顺序的自扩展。这意味着，锚固支架能够容纳在用于植入手术的储筒中。然后，锚固支架通过导管经由主动脉而输送至患病的心脏。一旦到达植入部位，就操纵储筒来释放支架环，以允许支架环自扩展。然后就连同锚固支架一起移动并定位储筒，使得支架环壁被引入相应病人的心脏瓣膜的腔穴中。这就使得可实现精确的定位。
然后，进一步操纵相应的储筒，使得连合环也被释放并且能够自扩展。当发生这一情形时，老的心脏瓣膜就被夹紧在支架环和连合环之间，并且心脏瓣膜假体展开而进入其展开的操作状态。
在植入结合有心脏瓣膜假体的锚固支架之后，可从病人体内经由主动脉取出导管连同储筒。
尽管设在锚固支架上的支架环可导致将以上述方式植入的心脏瓣膜假体的容易得多且更好的定位，但是，也可能出现不正确的植入，并且心脏瓣膜假体可能不能起作用或者不能令人满意地起作用。在某些情形下，可能不再能取出不起作用或者不能令人满意地起作用的心脏瓣膜假体，这就会导致在某些情形下相应的病人出现死亡率增加的风险。
在这种手术干预过程中，在穿过主动脉引入心脏瓣膜假体的过程中出现人体内主动脉的弯曲，也提出了另一问题。随着储筒和相应的导管在该手术过程中移动，必须能够适应以较小的大约50毫米的半径来进行大约180°的方向变化，同时不会造成对脉管壁的损伤。
发明内容
因此，本发明的目的是降低植入心脏瓣膜假体过程中对病人的风险。
该目的基于包含权利要求1中的限定特征的导管，通过本发明来实现。本发明的有利的实施例和设计可基于从属权利要求的限定特征来实现。
在一个优选实施例中，本发明所提出的导管可连同带有专利说明书WO 2004/019825中已知的自扩展式锚固支架的心脏瓣膜假体一起来使用，该专利申请WO 2004/019825的公开内容通过引用而结合于本文中。
带有连接于其上的心脏瓣膜假体的锚固支架在植入过程中可以折叠的状态而暂时地容纳在储筒单元内。
以这种方式准备的储筒单元能够可释放地连接在引导系统的近端。储筒单元和引导系统在外径上设置成尽可能小，以便它们可穿过病人的主动脉而毫无困难地引入，为此，主动脉内可用的总的自由截面积不应被完全填满。
所使用的引导系统在其长度上足够长，以便于将连同引导系统一起引入的储筒单元通过将储筒单元引入病人的腹股沟中，穿过主动脉而到达病人的心脏。
在引导系统上提供了柔性的可弯曲区域，通过该区域，就实现了将顺应于且允许病人主动脉弯曲的弯曲半径和弯曲角度。
用于操作储筒单元的元件通过具有中空内部的引导系统引入。这些操作元件能够操纵并以特定的方式移动储筒单元的部件。例如，储筒单元的部件的径向或侧向运动可通过操作元件来执行。以这种特定方式来移动储筒单元的部件将使得锚固支架的部件以顺序的方式而释放开，以便可以WO 2004/019825中所述的方式来进行植入和锚固。
例如，锚固支架的支架环可通过储筒单元的部件的旋转或通过其在近侧或远侧方向上的侧向运动而释放开，但是，其它部件，例如连合环，则继续以折叠的状态保持在储筒单元内，并且之后可通过相应地移动储筒单元的另一部件或通过继续储筒单元的同一部件的运动而扩展释放开，储筒单元的该同一部件之前仍使支架环能以折叠的状态保持在储筒单元内。
随着心脏瓣膜假体附接于其上的锚固支架的相应环扩展，通过例如缝合而连在锚固支架上的心脏瓣膜假体同时地展开。
在一个优选实施例中，除了用于储筒单元部件的操作元件以外，其它操作元件也穿过内部中空引导系统而引入，这些其它操作元件作用于可弯曲区域上，以便以特定的方式来影响其弯曲曲度。
尤其是因为经由操作元件所触发的牵引力，可弯曲区域的特定曲度可在植入过程中在穿透主动脉弯曲部时实现。拉伸绳线或拉伸丝可用作操作元件，其穿过内部中空的引导系统而延伸至可弯曲区域的近端边缘，并且在这里固定在引导系统上，在这种情形下，两个这种操作元件的着力点应设置成在直径方向上而彼此相对，另外，应设置成相对于要求可弯曲区域围绕其弯曲的弯曲轴线而成90°的角度。
例如，可以特定的方式来影响可弯曲区域的曲度，这是通过一旦完成植入之后，在借助于可弯曲区域使引导系统穿过主动脉中的弯曲部并拉出时，经由其中一个操作元件施加牵引力来实现的。
引导系统的可弯曲区域可以链节链的形式来提供，其中，单个的链节通过单个的链接头而彼此相连。则这种情形下，单个的链接头确实地接合在相应的相邻链节中。这些单个的链接头设计成使得在弯曲区域可保持超过180°的弯曲曲度，其中弯曲半径确保至少可实现主动脉的弯曲半径。
链节链的单个链节上的单个链接头也应以在单个链节上成对的方式设置成在直径方向上而彼此相对，并且平行于可弯曲区域的旋转轴线。
本发明提出的与导管一起使用的引导系统还应有利地设计成使得液体冷冻剂或药物制剂可通过内部中空的引导系统而循环到储筒单元。借助于这种液体冷冻剂，例如盐溶液，锚固支架可保持在形状记忆合金的转变温度以下。这就防止了体液能够渗透引导系统内部，并且应因此而保持液体压力足够高，以便阻止体液或体液内的其它元素渗透。
以适当的方式引入液体冷冻剂还可防止气体如空气进入主动脉和血液中。
为此，整个引导系统应尽可能是不透液体的。因此，在这种情况下以链节链形式提供的柔性的可弯曲区域可通过塑料软管从外部对其进行密封，以使得它是不透液体的。
可以特定方式移动以便释放开锚固支架环的储筒单元的这些部件优选以套筒形元件的形式来提供，它们的内径和外径彼此相匹配，使得这些部件可彼此套叠式地接合，并且其中至少两个套筒形元件具有相互匹配的内径和外径，使得带有心脏瓣膜假体的处于折叠状态的锚固支架可容纳在它们之间并以折叠的状态而保持。
当引入导管时，储筒单元应尽可能完全闭合，并且，为了便于从中穿过主动脉而引入，储筒单元应在其近端设有尖端，这种尖端优选是由柔性的材料、例如硅酮制成的。
当储筒单元到达相应的病人的心脏时，随后可执行适当的操纵，换句话说，移动储筒单元的部件/套筒形元件，以便顺序地释放开锚固支架的不同环，并且同时地展开固定于其上的心脏瓣膜假体。
然而，在执行这些动作时，锚固支架仍然牢固地保持在储筒单元上。为此，在设在远端、例如设在锚固支架上有孔环之处的储筒单元的一个套筒形元件上，提供锚固元件。在该位置，这些锚固元件连同锚固支架的远端部分一起也被储筒单元的套筒形元件覆盖，从而锚固元件的远端部分仍然保持在折叠的状态下。
在该位置，可以检查已经展开的心脏瓣膜假体的功能。一旦显示心脏瓣膜假体在起作用，则可通过移动之前覆盖锚固元件同锚固支架远端部分的套筒元件，来执行进一步的操纵，这就导致锚固支架的远端部分完全释放开，并且使得它随后可完全展开。
如果在检查时发现植入的心脏瓣膜假体未起作用或者未令人满意地起作用，则比较有利的是可移动锚固支架及心脏瓣膜假体而使之返回储筒单元，这是通过在相反方向上移动部件/套筒形元件并再次从病人体内取出所有部件即整个导管来实现的，从而大大降低了手术的风险，之后，可以在同一病人身上进行另一植入。
在本发明提出的导管的一个有利的实施例中，导丝(Fuehrungsdraht)也可延伸穿过整个导管。这种导丝已经用于这类手术，并且可穿过病人的主动脉而在引入导管之前延伸至心脏后面的部位。然后可将导管放置在储筒单元和引导系统之上并插入导丝中，然后沿着导丝而推入主动脉中到达病人的心脏。
为了监视引入导管以及操纵可弯曲区域、尤其是主动脉弯曲部的过程，优选在引导系统和/或储筒单元上提供标志元件，其由可吸收X射线的材料制成，因此可在手术过程中在X射线图像上精确定位相应的位置。
网式过滤器也可与本发明提出的导管一起使用，通过网式过滤器，可防止微粒穿过相应的病人的血液循环系统。这种网式过滤器可连接在引导系统上，使得它沿着径向方向而完全环绕于其上。就此而言，它应当是弹性地偏置的，使得它贴靠在主动脉的脉管壁上，从而确保形成微粒不可渗透的封闭。
另外，本发明提出的导管还可另外设有常规的气囊，该气囊设置并被载带在引导系统或储筒单元内部，或者它可穿过引导系统引入，直到锚固支架将要扩展。利用这种气囊(其体积可通过处于较高压力下的流体而增加)，将进一步有助于锚固支架的扩展。
如上所述可穿过引导系统内部引入并以牵引装置或压紧装置形式而提供的操作元件，可有利地由操纵部件来操纵。操纵部件可设计成手柄，通过这种手柄，可随后通过相应的手术医生来执行用于引入导管的运动。
其它控制元件也设置在这种操纵部件上，通过这些控制元件可启动操作元件的相应运动。应当以尽可能可测量的方式来执行相应的运动，例如具有适当的变换比率，应可能通过末端止挡件或至少掣子止动位置来限制相应的运动。这就使得可以保留特定的最大距离或角度，从而在实现锚固支架的顺序扩展或影响可弯曲区域曲度的特定方式时，可允许这样的最大距离或角度。就此而言，应当可以非常精细地调节末端止挡件或单个的掣子。
本发明提出的导管的所有部件，至少包括那些与相应病人直接接触并且还被引入主动脉中的部件，应当由与各自生物体相容的对应生物相容性材料制成。还应当可以对它们进行杀菌，在这种情况下，应当可使用其中一种标准的杀菌工艺。
下面将基于实例更详细地描述本发明。
附图说明
图1至4是示意图，显示了处于植入手术程序的不同的可能阶段中的本发明提出的导管的实例；
图5显示了带有操纵部件的导管的实例；以及
图6是分解图，显示了图5所示的操纵部件。
具体实施方式
图1至4旨在图解说明并提供对本发明提出的导管实例的更清楚理解。这些单个的图显示了在结合有心脏瓣膜假体的锚固支架10的植入过程中所进行的不同阶段。
图1所示本发明提出的导管实例连同完全封闭的储筒单元4一起显示出，储筒单元4包含锚固支架10，锚固支架10结合有处于非扩展状态并因此而处于折叠状态的心脏瓣膜假体，因此它可通过内部中空的引导系统1穿过适当的入口进入主动脉，并且穿过主动脉而到达病人心脏上的相应植入部位。
硅酮制成的柔性尖端在近端设置在储筒单元4上，该柔性尖端有助于引入手术程序，并且降低了损伤的风险。
储筒单元的部件5例如通过螺纹连接而可释放地连接在引导系统1的其它部件上。
可弯曲区域9与储筒单元4邻接，可弯曲区域9设计成并且在尺寸上设置成使得它可确保能够穿过毫无问题地穿过病人主动脉的弯曲部。
这种可弯曲区域9的可能的设计将在下文中说明。
还显示了内部中空的引导系统1的其它部件，并且图1至4显示了两个操作元件2和3穿过引导系统1而延伸至储筒单元4，在这种情况下，操作元件2同样地穿过内部中空操作元件3而到达储筒单元4。
操作元件2和3在这种情况下以一定长度的压力弹簧的形式来提供，其优选通过拉伸丝来加强。这种拉伸丝使得导管更安全，这是因为它在手术一旦完成后就从病人体内取出。
引导系统1的其它部件11显示位于左手侧，其可以大致套筒形部件的形式来提供，但是，这些部件必须被固定，使得它们足以抵抗压力和拉力，以便能够承受被引入主动脉中和再次从主动脉中取出。适当刚硬的塑料软管可用于这一用途，例如PTFE软管或带有PTFE基体的软管，这是因为它们足以与生物体相容，并且还能够经受杀菌处理。
图2显示了在到达相应病人心脏上的植入部位时的第一手术阶段的手术程序。储筒单元4的部件/套筒形元件7可通过操作元件2和/或3之一的远侧运动而在远侧方向上被拉回，使得锚固支架10的一些环，例如并优选为设在WO 2004/019825 A1中所公开的心脏瓣膜假体上的支架环，发生扩展并且沿着径向而向外偏置。
因此，可朝近侧方向来推动带有引导系统1和储筒单元4的整个导管，并将这些环(支架环)引入病人的老的心脏瓣膜的腔穴中。当手术医生感受到可觉察的阻力时，将锚固支架10的支架环引入老的心脏瓣膜的腔穴中的程序就完成了。
储筒单元4的部件/套筒形元件5然后可被向前朝向远侧而移动，使得锚固支架的其它环随后也可释放开，因此它们就可自扩展，并展开心脏瓣膜假体。
这种预先的阶段如图3所示，其中心脏瓣膜假体并未完全展开，并且锚固支架10也可能尚未完全锚固。
同样如图3所示，锚固支架10的远端部分仍然容纳在储筒单元4中，并且处于储筒单元4内的部件/套筒形元件7下面。一直保持这样的情形，直到展开和定位心脏瓣膜假体的过程已经到达可检查其功能的阶段。
如果检查显示不能正确地执行功能或者错误的定位，那么部件/套筒形元件7就可通过这两个操作元件2或3中的一个而被再次向近侧推动，使得带有心脏瓣膜假体的锚固支架10再次至少部分地容纳在储筒单元4内，并且整个导管随后可通过将其从主动脉中拉出而从病人体内取出，同时不会损害脉管壁。
如果功能检测显示心脏瓣膜假体至少足以能够履行其功能，那么就可朝向远端向回移动部件/套筒形元件7，如图4所示，或者，可在近侧方向上推动储筒单元4的另一部件/套筒形元件6，使得锚固支架10的远端部分也能够释放开并完全展开。
同样如图4所示，孔环或其它适当的元件设置在锚固支架10的远端区域，并且最初接合在部件/套筒形元件6上的锚固元件8中。如果确定结合有心脏瓣膜假体的锚固支架10是不正确地或不良地植入的，那么依靠带孔环的锚固元件8，就可确保可靠的收回和取出，从而使得锚固支架10和心脏瓣膜假体可从病人体内取出。
通过锚固元件8以及可选择性地设置在储筒单元4的部件/套筒形元件6上的其它引导元件16，还可以执行径向旋转运动，以使得锚固支架10的环能够被引入老的心脏瓣膜假体的腔穴中而处于精确地正确的位置，例如，在这种情形下，在植入过程中，可通过手术医生使整个导管围绕其纵轴线稍微旋转。
图4的细节A还特别显示了插管12，其穿过储筒单元4沿着其纵轴线而被引入。通过插管4，则在本说明书发明内容部分所述的导丝就可穿过储筒单元4而引入。
图5显示了带有另外的操纵部件13的导管实例，在该导管上设置了其它控制元件，以便允许进行操纵。
引导系统1连同以上参见图1至4所述的储筒单元4也用于该实例中。
然而，细节A显示了链节链形式的可弯曲区域9的一种可能的设计。
单个的链节9.1一般具有相同的形状和尺寸。
在这方面，单个的链节9.1的相对面向的端面的形状设置可形成单个的链接头9.2，各个链接头9.2确切地接合在相邻的单个的链节9.1中，由于在单个的链节9.1之间分别具有足够的间隙宽度，因此就保证了可弯曲区域如上所述能够弯曲至少大约180°，并且弯曲半径为大约50毫米。
通过单个的链节9.1的相应的相对面向的端面中的切口，而形成单个的链接头9.2，因此一个端面上的相配切口与在单个链节9.1的径向面对的端面上的相配浑圆突起部位一起，就形成了相应的相邻单个的链节9.1上的单个的链接头9.2。
尽管未示出，但是，可弯曲区域9可通过塑料软管封闭，以便使得它是流体不能渗透的。
图5还显示了可如何提供操纵部件13，以便能够引入和操纵本发明提出的导管。
提供了手柄13.1，用于引入和收回带引导系统1和储筒单元4的导管。
板17形式的流体不能渗透的封闭件设置在操纵部件13的近端部分上，从而使得引导系统1能够通过锁紧螺母23而在凸缘上安装固定，并且提供了密封元件，但这些元件在这里并未显示出。
还提供了标准的Luer接头30，冷冻剂液体可通过该接头30而流通。
可弯曲区域9的相应弯曲可利用手柄19来得到，手柄19可通过拉伸绳线(未示出)而围绕其轴线转动，这将在图6的描述中作进一步的说明。
整个操纵部件13应相对于周围环境并相对于引导系统1密封起来，使得它尽可能是流体不能渗透的，并且在必要时还是气体不能渗透的。
管28可通过作用在手柄13.1上的杆20而在近侧方向上侧向移动，并且对应的运动和所产生的牵引力或压力传递给两个操作元件2和/或3的其中一个操作元件，从而使得可以如上所述的方式来执行对储筒单元4的单个部件/套筒形元件5，6和/或7的操纵，例如如前所述的借助于杆20的泵送运动而达到精确测量的状态。
推手柄25使得可相对于储筒单元4的套筒形的部件6来操纵储筒单元4的部件5的位置，通过用作锚固元件8的固定挂钩而延伸至超出弹簧的长度。推手柄25通过压力弹簧而锁定在管28的螺纹形的带齿部28.1上。结果，推手柄25就顺应于管28沿近侧方向的运动，管28经由用作操作元件3的一定长度的弹簧而连接在储筒的部件6上。
在到达标示第一排出阶段的末端止挡件时，推手柄25可转动，以便执行储筒单元4的部件5相对于储筒单元4的部件6在螺纹部28.1的节距的方向上的精确测量的轴向移动。
就操作推手柄25而言，推手柄25能够使这里所示的储筒单元4的部件5移动，而无需另外的精细调节。
这种操纵使得能够释放开锚固支架10(见图3)，并且在该位置仍可收回锚固支架10。
当止挡件29通过例如调节螺丝形式的促动器部件31而释放开时，就可通过以如上所述的方式操作杆系统20，来进一步收回储筒单元4，直到锚固支架10的支撑孔环已经移动离开储筒单元4并且锚固支架10能够因其扩展力而弹离开锚固元件8。
储筒单元4的元件可逐步地被向回拉。可通过向回拉动推手柄25(推动元件锁定)而超出储筒单元4的部件，来收回储筒单元4的部件6。
通过操作松开螺栓32，连接在管28上的储筒单元4的部件6也可回到其初始位置，这是通过进一步向回拉动推手柄25而使得储筒单元4随后再次完全封闭来实现的。在这种情形下，可再次从病人体内取出导管。
图6是分解图，更详细地显示了用于该实例的操纵部件13。
如该图所示，当手轮19经由轴14转动时，就可以移动两个定向成彼此平行的齿条24。因此，随着定向成与之平行的一个齿条24在远侧方向上移动，则另一个齿条24在近侧方向上移动。
虽然在这里没有显示出，但是，拉伸缆线可固定在作用于相配齿条24上的夹钳21上，拉伸缆线穿过内部中空的引导系统1而引入并延伸至可弯曲区域9，并且优选在其近侧区域是固定的。
因此，通过转动手轮19，就可将牵引力施加在两条拉伸缆线中的至少一条上，从而导致可弯曲区域9以可测量的状态而呈现适当的曲度，使得引导系统1连同储筒单元4一起可以限定的方式穿过主动脉的弯曲部而引入。
在图6还显示，连接在手柄13.1上的杆20借助于管28上的细齿部28.1而起作用，使得它能够借助于操作元件2和/或3而被操纵，从而允许锚固支架10的顺序的释放。

Claims (16)

1.一种用于穿过血管而植入带自扩展式锚固支架的心脏瓣膜假体的导管，以便使所述心脏瓣膜假体连同所述锚固支架一起在所述植入的过程中以折叠的状态而暂时地容纳在储筒单元内；
所述储筒单元可连在引导系统的近端上，并且所述引导系统具有可弯曲区域，从而使得它能够穿过主动脉，其特征在于，
操作元件(2，3)穿过所述内部中空的引导系统(1)引入而到达所述储筒单元(4)，以便使所述储筒单元(4)的部件(5，6，7)围绕其纵轴线而沿径向地移动和/或在所述近侧和远侧方向上侧向地移动，以允许所述锚固支架(10)的单个的部件连同所述心脏瓣膜假体一起可顺序地释放开。
2.根据权利要求1所述的导管，其特征在于，在所述引导系统(1)的所述可弯曲区域(9)上提供操作元件，其以特定方式起作用，以便影响所述可弯曲区域(9)的曲度。
3.根据权利要求1或2所述的导管，其特征在于，所述可弯曲区域(9)以带有单个的链接头(9.2)的链节链的形式来提供。
4.根据前述权利要求中任一项所述的导管，其特征在于，所述单个的链接头(9.2)分别确切地接合在相邻链节(9.1)中。
5.根据前述权利要求中任一项所述的导管，其特征在于，所述操作元件以作用于所述可弯曲区域(9)上的张紧机构的形式来提供。
6.根据前述权利要求中任一项所述的导管，其特征在于，液体冷冻剂穿过所述引导系统(1)的内部而流通至所述储筒单元(4)。
7.根据权利要求6所述的导管，其特征在于，所述引导系统(1)被设计成是不透液体的。
8.根据前述权利要求中任一项所述的导管，其特征在于，所述储筒单元(4)设有若干个彼此套叠地接合的套筒形元件(5，6，7)，在这些套筒形元件(5，6，7)之间以折叠的状态而封闭且夹持了所述锚固支架(10)和心脏瓣膜假体，直到所述植入。
9.根据前述权利要求中任一项所述的导管，其特征在于，当由于所述储筒单元(4)的其它元件(5，6或7)的径向和/或侧向运动而使结合有所述心脏瓣膜假体的所述锚固支架(10)的部件展开时，还利用安装在所述储筒单元(4)的套筒形元件(6)上的锚固元件(8)并通过结合有所述引导系统(1)的所述储筒单元(4)上的远端而将所述锚固支架(10)保持固定，因此就能够检查所述心脏瓣膜假体，以保证它在起作用。
10.根据前述权利要求中任一项所述的导管，其特征在于，导丝穿过所述导管的内部而引入。
11.根据前述权利要求中任一项所述的导管，其特征在于，其吸收X射线的标志元件设置在所述引导系统(1)和/或所述储筒单元(4)上。
12.根据前述权利要求中任一项所述的导管，其特征在于，网式过滤器连接在所述引导系统(1)上并径向地环绕所述引导系统(1)。
13.根据前述权利要求中任一项所述的导管，其特征在于，气囊设置在所述储筒单元(4)的所述引导系统(1)的内部，或者可穿过所述引导系统(1)的内部而引入，直到所述锚固支架(10)扩展。
14.根据前述权利要求中任一项所述的导管，其特征在于，穿过所述引导系统(1)的内部而引入的所述操作元件、张紧机构和压力机构可通过操纵部件(13)来操纵。
15.根据权利要求14所述的导管，其特征在于，所述操纵部件以带有控制元件的手柄的形式来提供。
16.根据前述权利要求中任一项所述的导管，其特征在于，延伸至所述储筒单元(4)的套筒形元件(6，7)的所述操作元件(2，3)以一定长度的压力弹簧的形式来提供。
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CN114931696A (zh) * 2022-05-19 2022-08-23 南京脉创医疗科技有限公司 一种桡动脉通路神经介入导管

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DE102005003632A1 (de) 2006-08-17
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CA2595233C (en) 2011-05-17
CA2595233A1 (en) 2006-07-27
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US20200129290A1 (en) 2020-04-30
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US11517431B2 (en) 2022-12-06
EP1848375A1 (de) 2007-10-31
CN102836019A (zh) 2012-12-26
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CN102836019B (zh) 2015-10-28
CN101128168B (zh) 2012-08-08
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US9788945B2 (en) 2017-10-17
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US20140214153A1 (en) 2014-07-31
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US20180021132A1 (en) 2018-01-25
US10492906B2 (en) 2019-12-03
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IL184608A0 (en) 2007-12-03
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