CN103517689B - 用于压缩/装载支架瓣膜的方法和设备 - Google Patents
用于压缩/装载支架瓣膜的方法和设备 Download PDFInfo
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- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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Abstract
一种用于压缩经导管心脏支架瓣膜(10)的设备(40),包括:中空通道(42),其具有成形为响应于支架瓣膜在通道内的纵向前进而逐步压缩支架瓣膜的内表面(50);驱动器(46),其螺纹接合在通道的外部以响应于旋转来产生纵向驱动力;推进器(44),其具有在通道壁内穿过狭槽(58)伸出的分支(56)以将驱动力传递至通道内的支架瓣膜;以及通道延长段(48),其可移除地附接在出口(54)以提供大体上圆柱形的内含孔(66)。
Description
技术领域
本发明涉及用于经导管传送的支架领域,并且尤其涉及用于将支架压缩至压缩状态和/或用于针对传送导管装载支架的方法和设备。在一些非限制性方面,支架是支架瓣膜,例如心脏内支架瓣膜。在解决支架瓣膜所遇到的问题的同时设计了本发明,但是本发明还可应用于压缩用于经导管传送的其他类型的支架。
背景技术
WO2009/053497A描述了心脏内支架瓣膜和用于经由微创手术传送支架瓣膜的相关方法和系统。支架瓣膜可压缩至压缩状态,其适于安置在传送导管的传送尖端。在压缩状态下,小尺寸使得承载支架瓣膜的导管能够通过微创手术被引导。在期望植入位点被释放时,支架瓣膜扩展至有效尺寸。
支架瓣膜、传送导管、和/或用于压缩支架瓣膜以进行传送的技术的其它实例在US2009/0171432、WO2008/035337和WO2009/116041中描述。
将支架瓣膜压缩至(或准备用于)传送导管的任务很复杂,这是因为支架瓣膜易碎并且容易损坏。损坏可能是由于过度压缩,或者不均匀的应力分布,或者压缩期间的弯曲、或不圆度,或来自瓣膜成分组织的撕裂或磨损。变形或损坏的支架瓣膜功能会有缺陷,或使用期限缩短,或者可能很难或者甚至不能正确植入。在自膨胀类型支架瓣膜的情况下会更加困难,这是因为当压缩时自膨胀支架瓣膜具有强大的复原力,并且需要用很大的压缩力以将支架瓣膜向下压缩至其压缩状态。较大的力难以施加至易碎的支架瓣膜。自膨胀支架瓣膜还会更倾向于不期望地变形为非圆形形状,除非在压缩过程中仔细控制其形状。进一步的考虑涉及辅助装置的数量和体积,这必须考虑到仅用于将支架瓣膜准备或装载入传送导管的手术室中。
存在的挑战是提供一种用于压缩支架瓣膜的技术,其相对简单且直观易用,实施起来便宜,利用不过于庞大且便于消毒的设备,并且还避免了上面讨论的问题。
发明内容
本发明设计为将这些问题考虑在内。非限制性目标在于解决和/或减轻上述问题中的至少一个。
本发明的某些方面在权利要求书中限定。
一般来说,本发明的另一方面提供了一种用于将支架(优选为支架瓣膜)压缩至期望尺寸以安装在传送导管上的设备。该设备可包括以下部件中的一个或多个:
中空通道(其可选地另外或作为选择地被称为中空通道构件或中空通道主体),具有成形为响应于支架在中空通道内纵向前进而逐渐压缩支架的内表面;以及
推进器,用于向支架施加纵向驱动力以在中空通道内推动支架。
可选择地,该设备可被配置为具有两个或多个下述特征的一种或任意组合,其全部都是可选择的:
(a)该设备还包括驱动器,用于产生驱动力,推进器被配置为将来自驱动器的驱动力传递至支架以在通道内推进支架。驱动器可安装在通道外部或通道上,例如,径向安装在外部或径向安装在外面。驱动器可包括可在外部绕通道的纵轴旋转的构件,以及螺纹和/或螺旋引导件,用于产生响应于旋转的纵向运动。例如,驱动器可螺纹耦接至通道的外部。在一些实施方式中,通道具有(ⅰ)带有针对驱动器的螺纹的通常为圆柱形的外部,和/或(ⅱ)通常为非圆柱形的内部,用于使支架瓣膜折叠。通常为非圆柱形的内部可选地包括大体上圆形的横截面形状,其直径沿纵轴的一个或多个区域逐渐减小。
(b)中空通道可包括至少一个穿过其壁的狭槽,并且推进器可包括可在狭槽内滑动且穿过狭槽伸出以接合通道内的支架的部分。狭槽可为大体上线型的和/或纵向延伸。可选择地,通道包括两个狭槽,或者可选择地,通道包括三个狭槽,或者可选择地,通道包括四个狭槽,或者可选择地,通道包括五个狭槽,或者可选择地,通道包括六个狭槽,或者可选择地更多。推进器可包括相应数量的所述部分,一个部分对应一个狭槽。此外或者作为选择,中空通道可包括具有至少一个在其内延伸的狭槽的构件。例如,狭槽可延伸超过构件轴向长度的至少50%,可选择地至少55%,可选择地至少60%,可选择地至少65%,可选择地至少70%,可选择地至少75%,可选择地至少80%,可选择地至少85%,可选择地至少90%,可选择地至少95%。作为选择,中空通道可包括组装(或能够组装)在一起以共同限定中空通道形状的多个构件。不论哪种情况,狭槽可选择地在通道的至少一端开放,以允许推进器通过滑出狭槽的开放端而与通道分离。
可选择地,中空通道包括多个狭槽,并且推进器包括(ⅰ)多个可在狭槽内滑动的所述部分,以及(ⅱ)装配在通道外面、例如径向装配在外面的部分(例如,径向地位于通道的圆周外面)。装配在外面的该部分可以径向在通道外面互连可在狭槽内滑动的部分。例如,装配在外面的部分可以连接可在狭槽内滑动的部分的径向外端。
(c)推进器可被配置为向围绕支架圆周的至少一个(可选择地两个、或可选择地三个、或可选择地四个、或可选择地更多)圆周位置施加纵向驱动力。这可使得驱动力能够施加至一个或多个特定的圆周位置,在这些位置,支架(例如支架瓣膜)相对粗壮和/或更不易于损坏或变形。例如,力所施加的一个或多个圆周位置可与支架瓣膜的连合支撑结构或支柱大体上对齐。作为选择,力所施加的一个或多个圆周位置可与支架瓣膜的连合支撑结构或支柱大体上不对齐。
(d)推进器可被配置为沿支架的轴向长度向至少一个(可选择地两个、或可选择地三个、或可选择地四个、或可选择地更多)纵向位置施加纵向驱动力。这使得驱动力能够施加至一个或多个特定的纵向位置,在这些位置,支架相对粗壮和/或更不易于损坏或变形。例如,力所施加的一个或多个纵向位置可以对应于支架瓣膜的连合支撑结构或支柱。此外或作为选择,一个或多个纵向位置中的每一个可以对应于支架轮廓或结构中的谷(例如在两个支柱之间顶点接合点处定义的谷)。
(e)推进器可被配置为向位于支架两个末端中间的至少一个(可选择地两个、或可选择地三个、或可选择地四个、或可选择地更多)特定位置施加纵向驱动力。这使得能够施加“推动”力而减小支架轴向弯曲的风险。此外或作为选择,这使得能够施加“牵引”力而不依赖或干扰支架的末端。支架可包括一个或多个位于支架末端的附接元件。这样的布置并不妨碍通过附接元件的接合或使通过附接元件的接合复杂化。此外或作为选择,每个位置可对应于支架轮廓或结构中的谷或凹面(例如在两个支柱之间顶点接合点处定义的谷)。可选择地,该至少一个位置可以是:与支架的两个相对端部间隔至少5mm,优选为至少10mm;和/或与支架的两个相对端部间隔为支架瓣膜最大长度的至少10%,优选地至少15%。
(f)推进器可包括围绕通道外部延伸的环,以及从环向内延伸或伸出的一个或多个分支。分支可为叶片状和/或指状和/或销钉状和/或轮辐状。环可绕通道外部纵向滑动。每个分支可延伸通过通道壁内的相应狭槽,以朝着通道内部延伸。每个分支可在相应狭槽内滑动。分支的内端大体上是自由的,或者内端可彼此耦接,例如,在同一点(例如,中心)汇合或通过内环耦接。
(g)配置为与支架接合的推进器的部分或表面(例如,上述的每个分支,如果使用的话)可关于通道轴和/或环所在的平面(如果使用的话)以基本上径向的方向延伸。作为选择,配置为与支架接合的推进器的部分或表面可关于径向方向和/或环平面倾斜。在一种形式中,该部分以朝向通道出口和/或窄端(例如,内部较窄)的方向倾斜。倾斜角度(例如,朝向出口/窄端)可为约5度(或更大)、约10度(或更大)、约15度(或更大)、或约20度(或更大)。倾斜角度可大约处于上述数值的任意两个之间,例如,处于约5度和约15度之间。倾斜可减小支架在轴向压缩载荷下弯曲的风险。倾斜可趋于适当地以径向向外的方向推动支架,而不是径向向内。通过与通道的内表面接触来抗衡适当的径向向外推动,从而使得能够控制支架的形状以避免弯曲。
(h)中空通道的内表面至少在径向方向上大体上固定和/或不可移动。支架瓣膜的压缩至少主要(并且优选地全部)是由于支架瓣膜在通道内的纵向位移而实现,而不存在通道内表面大体上径向的移动。
(i)中空通道的内表面可包括至少一个非圆柱形部分,例如,具有以朝向出口的方向沿通道纵轴逐渐减小的直径。此外或作为选择,通道可包括至少一个基本上圆柱形的部分。在所示出的实施方式中,内表面包括至少两个非圆柱形部分。邻近通道入口的内表面部分基本上为圆柱形。邻近通道出口的内表面部分基本上为非圆柱形。
(j)设备可进一步包括装载管(其可选地另外或作为选择地被称为通道延长段或出口延长段)用于或者可用在通道出口端和/或窄端(例如,内部较窄)。装载管可移除地附接至通道,或者它可通过用手保持就位而与通道相关联,或者它可插入通道出口内。当延长段从通道分离(例如,移除)时,这允许支架末端可在通道的出口端/窄端被观察到,以装载在传送导管上或与传送导管接合。在将支架末端装载/接合至传送导管后,延长段可关于通道被放置、插入或重新放置(例如,附接或重新附接)。在一些实施方式中,装载管内部具有孔。在一些实施方式中,孔可以具有与通道的出口端大体上相同的直径。在其它实施方式中,装载管的孔和/或外径可略小于通道出口处的直径。
在一些实施方式中,装载管可通过承担通道和延长段之间纵向载荷的固定件被附接。例如,固定件可为螺纹固定件。在其它实施方式中,装载管可在出口处或通过出口至少部分地插入通道中。
(k)中空通道的纵向长度可大于支架瓣膜,以使得在使用时,支架瓣膜在被推进时完全包含在通道内。
(l)在使用时,支架瓣膜可从位于一端的入口完全穿过中空通道到达位于相对端的出口。
(m)支架瓣膜可首先被推进中空通道内的流入端。流入端可以是从中空通道的出口出现的第一端。作为选择,支架瓣膜可首先被推进中空通道内的流出端。流出端可以是从中空通道的出口出现的第一端。
在另一方面,本发明提供了一种用于压缩经导管心脏内支架瓣膜的设备,包括以下部件中的一个或多个:中空通道,其具有成形为响应于支架瓣膜在通道内纵向前进而逐步压缩支架瓣膜的内表面;驱动器,其螺纹接合或者可接合在通道的外部以响应于旋转产生纵向驱动力;推进器,其具有在通道壁内穿过狭槽伸出的分支以将驱动力传递至通道内的支架瓣膜;以及通道延长段,其可移除地附接在出口以提供大体上圆柱形的内含孔。
在另一方面,本发明提供了一种用于压缩经导管心脏内支架瓣膜的设备,该设备包括:中空通道,其具有成形为响应于支架在中空通道内的纵向前进而逐步压缩支架瓣膜的内表面,中空通道包括至少一个穿过其壁的狭槽;以及推进器,其包括装配在中空通道圆周外围的部分和可在狭槽内滑动并且穿过狭槽伸出以与中空通道内的支架瓣膜接合的部分,用于将来自中空通道外部的纵向驱动力施加至支架瓣膜。
在另一方面,本发明提供了一种设备,包括:
经导管心脏内支架瓣膜,其具有第一和第二相对端;
中空通道,其具有成形为响应于支架在中空通道内的纵向前进而逐步压缩支架瓣膜的内表面;以及
推进器,用于与中空通道内的支架瓣膜接合,以将来自中空通道外部的纵向驱动力施加至支架瓣膜,推进器被配置为在支架瓣膜的第一和第二相对端中间的至少一个位置与支架瓣膜接合。
在另一方面,本发明提供了一种用于压缩经导管心脏内支架瓣膜的设备,包括:
中空通道,其具有成形为响应于支架瓣膜在中空通道内的纵向前进而逐步压缩支架瓣膜的内表面;以及
驱动器,其通过螺纹耦接至中空通道,并且被配置为响应于驱动器的旋转来产生纵向驱动力以推进支架瓣膜。
在另一方面,本发明提供了一种用于压缩经导管心脏内支架瓣膜的设备,包括:
中空通道,其具有入口和出口,入口具有比出口更大的孔,中空通道还具有成形为响应于支架瓣膜在中空通道内的纵向前进而逐步压缩支架瓣膜的内表面,内表面包括选自以下的至少一个:
(i)至少一个基本上圆柱形的表面和至少一个基本上非圆柱形的表面;
(ii)多个基本上圆柱形的不同表面。
在另一方面,本发明提供了一种用于压缩经导管心脏内支架瓣膜的设备,包括:
中空通道,其具有成形为响应于支架瓣膜在中空通道内的纵向前进而逐步压缩支架瓣膜的内表面;以及推进器,用于向通道内的支架瓣膜施加纵向驱动力,推进器包括环,多个分支从环开始延伸,分支从环开始基本上向内延伸,并且关于环所在的平面倾斜。
在另一方面,本发明提供了一种压缩经导管心脏内支架瓣膜的方法,包括以任何顺序的下述步骤:
(a)提供具有入口和出口的中空通道,中空通道还具有成形为响应于支架瓣膜在通道内的纵向前进而逐步压缩支架瓣膜的内表面;
(b)在通道入口处插入支架瓣膜;以及
(c)从通道的径向外部施加纵向驱动力以在通道内将支架瓣膜推向出口。
在另一方面,本发明提供了一种压缩经导管心脏内支架瓣膜的方法,包括以任何顺序的下述步骤:
(a)提供具有入口和出口的中空通道,中空通道还具有成形为响应于支架瓣膜在通道内的纵向前进而逐步压缩支架瓣膜的内表面;
(b)在通道的入口处插入支架瓣膜;以及
(c)相对于中空通道旋转驱动器,以通过螺纹产生径向驱动力,以在通道内将支架瓣膜推向出口。
在另一方面,本发明提供了一种压缩经导管心脏内支架瓣膜的方法,包括以任何顺序的下述步骤:
(a)提供具有入口和出口的中空通道,入口具有比出口更大的孔,中空通道还具有成形为响应于支架瓣膜在中空通道内的纵向前进而逐步压缩支架瓣膜的内表面;
(b)针对中空通道提供装载管;
(c)将装载管放置在传送导管的至少一部分上;
(d)在通道的入口处插入支架瓣膜;
(e)向支架瓣膜施加推动力以在通道内将支架瓣膜推向出口,直到支架瓣膜的一部分出现在出口处;
(f)将出口处支架瓣膜的部分耦接至传送导管的支架固定器;
(g)平移传送导管的内含护套,以在耦接至支架固定器的支架瓣膜的部分中捕获;
(h)在传送导管上移动装载管以将装载管耦接至中空通道和/或将装载管插入通道的出口内;以及
(i)向支架瓣膜再次施加推动以进一步朝向中空通道的出口推进支架瓣膜。
在另一方面,本发明提供了一种压缩经导管心脏内支架瓣膜的方法,该方法包括以任何顺序的下述步骤:
(a)提供具有入口和出口的中空通道,入口具有比出口更大的孔,中空通道还具有成形为响应于支架瓣膜在中空通道内的纵向前进而逐步压缩支架瓣膜的内表面;
(b)将支架瓣膜插入通道的入口;以及
(c)在支架瓣膜相对端中间的至少一个位置向支架瓣膜施加纵向驱动力,以在通道内将支架瓣膜推向出口。
在另一方面,本发明提供了一种设备,包括:
传送导管,用于将支架瓣膜传送至体内的植入位点,传送导管在内含区域具有至少一个可平移的护套,用于接收压缩形式的支架瓣膜,其压缩形式源于用于针对传送导管来压缩和装载支架瓣膜的装载操作;用于在使用前容纳传送导管的包装,该包装包括具有液密水槽的底座,水槽具有适用于容纳液体的深度,在装载操作期间导管的内含区域可被浸入在该深度内。
在另一方面,本发明提供了一种准备支架瓣膜和传送导管以供使用的方法,该方法包括:
(a)提供容纳传送导管的封闭包装,该包装包括将传送导管支撑在存储位置的底座,底座具有液密水槽;
(b)打开封闭包装;
(b)将液体导引入底座的水槽中;
(c)将支架瓣膜装载至传送导管的内含区域,同时至少内含区域浸入水槽的液体中。
本发明不同方面的特征和优势包括以下中的一个或多个:(ⅰ)相对简单且直观易用,(ⅱ)实施便宜,(ⅲ)使用能够便于消毒的设备,(ⅳ)避免了对支架一端处附接区域的干扰,(ⅴ)避免支架的弯曲,(ⅵ)提供了对压缩期间支架形状的精确控制,(ⅴ)便于将支架装载在传送导管上,(ⅵ)使得至少支架的主要部分能够实现压缩,而不与传送导管的支架固定器加压接合,(ⅶ)通过单个操作者就能够容易地实现,和/或(ⅷ)通过在装置包装时装载/压缩就位而减少了用于手术室的辅助装置的数量。
虽然本发明的不同特征和观点在上面描述并且在所附的权利要求书中限定,但其它特征和优势将通过下面对于具体实施方式的非限制性描述而变得显而易见。不论是否进行了强调,所要求的保护针对本文所描述和/或附图中所示的任何新颖性特征或观点。
附图说明
现将仅通过实例、并参考附图来描述本发明的非限制性实施方式,其中:
图1是支架瓣膜和传送导管实例的示意图。
图2是图1的支架瓣膜的支架组件的示意侧视图。
图3是用于压缩装载到传送导管上的支架瓣膜的设备的示意分解截面图。
图4是图3的设备的中空通道的示意透视图;
图5是图3的设备的推进器的示意透视图;
图6是利用该设备的一个实例的图解指南;以及
图7是与支架瓣膜接合以对其施加驱动力的推进器的示意侧视图(在图7中忽略其它组件以避免模糊视图);
图8是用于传送导管的包装的示意侧视图,该包装示为具有与底座分离的盖;
图9是类似于图8的示意截面;
图10是沿图8的线A-A的示意截面;
图11是沿图8的线B-B的示意截面;
图12是沿图8的线D-D的示意截面;
图13是图8的包装的底座的平面图;以及
图14是类似于图13的底座的平面图,但指示了传送导管定位在合适位置。
具体实施方式
在详细描述压缩设备之前,首先描述支架(支架瓣膜)实例,从而压缩设备的特征和功能将会被充分理解。
图1和2示出了支架瓣膜10形式的支架实例。支架瓣膜10可为心脏内支架瓣膜,例如主动脉支架瓣膜。支架瓣膜10可被配置用于经导管植入在体内,例如使得能够利用微创技术。支架瓣膜10可被配置用于经导管主动脉瓣植入(“TAVI”)。虽然以实例的方式示出了支架瓣膜10的特定几何形状,但应当理解的是,本发明并不限于任何特定的支架瓣膜几何形状。本文所用的几何形状实例是由于它能够使本发明的优势得以凸显。
支架瓣膜10可在展开状态(如图1中所示)和由虚线10’所示的压缩状态之间转换。展开状态大致对应于植入后支架瓣膜的有效状态。支架瓣膜10在植入处可以不完全到达展开状态,允许存在偏差以适应尺寸不匹配和/或用于略微压缩以保持向外的弹性偏压以摩擦适配在本体解剖结构中。压缩状态10’对应于适于传送导管12和/或用于引导进入期望植入位点的解剖结构的传送状态。
支架瓣膜10可为自膨胀类型,其弹性地偏向展开状态,并且可通过施加合适的径向压缩力而压缩至压缩状态10’。当被压迫时支架瓣膜10保持在其压缩状态。当解除压迫时,支架瓣膜10自膨胀至展开状态。作为选择,支架瓣膜10可为非自膨胀类型,其需要施加膨胀力以使支架瓣膜10从压缩状态10’转换至展开状态。
支架瓣膜10可包括支架组件14和瓣膜组件16。支架组件14可提供锚定作用以将支架瓣膜锚定在本体解剖结构中和/或提供支撑作用以支撑瓣膜组件16。支架组件14可以是任意合适的材料或多种材料。支架组件14可为金属。示例性材料包括形状记忆和/或超弹性合金(例如,镍钛合金)、不锈钢、或钴-铬合金。在所示形式中,支架组件14是自膨胀的并且为形状记忆/超弹性合金(例如镍钛合金)。然而,支架组件14也可以是基本上非自膨胀的。
支架组件14可具有在期望的植入位点关于本体解剖结构锚定和/或对准支架瓣膜10所需要的任意轮廓。在一些实施方式中,支架组件14可以是基本上圆柱形的形状,或者包括一个或多个基本上圆柱形的部分或位于基本上圆柱形表面上的部分(例如,20c和22a)。此外或作为选择,支架组件14可以是基本上非圆柱形的形状或包括一个或多个基本上非圆柱形部分或位于非圆柱形表面上的部分(例如,20a、20b和24)。此外或作为选择,支架组件14可包括一个或多个锚定突起和/或一个或多个稳定部。
在所示出的形式中,支架组件14可选择地包括锚定部20,其例如由下冠20a和上冠20b限定,在它们之间限定凹槽和/或腰部20c。锚定部20可具有第一抗压力,并且可包括多孔栅格。
支架组件14可选择地(还)包括瓣膜支撑部22,其例如包括多个(例如,三个)连合支柱22a。连合支柱22a可布置在小于冠20a和20b中的至少一个的末端的节圆直径上。连合支柱22a可布置在对应于腰部20c的节圆直径上。连合支柱22a可在轴向方向上与冠20和22中的至少一个部分重叠,并轴向延伸超过该相应的冠。连合支柱22a可为框架形。连合支柱22a至少在邻近连合支柱的瓣膜周围区域中具有至少近似符合瓣膜外周轮廓的形状。
支架组件14可选择地(还)包括稳定或对准部24,其例如由多个(例如,三个)侧翼或弓形24a限定。弓形24a可以从连合支柱22a的尖端开始延伸,以限定在其上的拱形结构。对准部24可以具有比锚定部20和/或瓣膜支撑部22更大的弹性。对准部24可以具有小于压缩锚定部20的第一抗压力的第二抗压力。对准部24可以具有比锚定部20和/或瓣膜支撑部22更小的硬度(例如,径向)。
支架组件14可选择地(还)包括附接部26,用于将支架组件14附接至传送导管12的支架接收器28。在所示的实施方式中,支架接收器28可以是支架固定器并在下文中称之为此,虽然用于接收和/或容纳至少一部分支架瓣膜10的其他类型的接收器也可根据需要来使用。附接部26可包括一个或多个几何开口,或者一个或多个凸耳或其它突起,用于形成与支架固定器28的互补部分过盈(例如联锁)配合。附接部26可布置在支架组件14的至少一个末端处或邻近支架组件14的至少一个末端。在本实施方式中,附接部26由下冠20a的单元的多个(例如三个)延长段来限定。
瓣膜组件16可以是任意合适的天然和/或合成材料。例如,瓣膜组件16可包括猪和/或牛的心包和/或获得的天然瓣膜材料。瓣膜组件16可包括多个小叶,其布置为接合或折叠到闭合位置以阻碍一个方向上的流动,同时弯曲分离至打开位置以允许向相反方向上的流动。瓣膜组件16可安置在瓣膜支撑部22上和/或至少部分地位于锚定部20内。支架瓣膜10(例如瓣膜组件16)还可包括内裙缘和/或外裙缘,其至少部分地覆盖支架组件14的相应内表面或外表面部分。例如,裙缘可覆盖至少部分锚定部20和/或至少部分瓣膜支撑部22。
仍然参照图1,仅以实例的形式,传送导管12在传送导管12的内含区域包括至少一个护套30,用于安置支架瓣膜10。该至少一个护套30可配置为覆盖处于压缩状态10’的支架瓣膜10的至少一部分,用于约束支架瓣膜10避免膨胀。响应于通过在传送导管12的手柄端32处的控制的激励,该至少一个护套30可沿导管的轴平移以选择性地覆盖或暴露支架瓣膜10的相应区域。支架固定器28可以阻止或至少减小护套30平移时支架瓣膜10轴向位移的任何趋势,和/或阻止或至少减小当仅有支架瓣膜10的小部分被护套30覆盖时支架瓣膜10跃出护套30的任何趋势。支架固定器28可承载在中心管36(或者多个管的组件)上,例如,用于接收导线。装载尖端34可移除地安装在管36的最远端。可以使用传送导管12的其它设计,例如,没有护套30和/或没有支架固定器28。本文中使用示例性传送导管12的原因在于它能够使本发明的优势得以凸显。
支架瓣膜10在其展开状态时的最大外径可为从约25mm至约35mm。相比之下,支架瓣膜在其针对传送导管的压缩状态10’时的最大外径会显著小于例如约10mm或更小。压缩支架瓣膜所需要施加的径向力是相当大的,例如,至少50N,或至少75N,或至少100N。在一些实施方式中,径向力在约100N和120N之间。
参照图3-7,所示的设备40用于压缩支架瓣膜10至其压缩状态10’。设备40还被配置为便于将支架瓣膜10装载至传送导管12上作为压缩过程的一部分。
设备40可包括两个或多个以下组件的一个或任意组合:中空通道(或中空通道构件或中空通道主体)42;推进器44;驱动器46;装载管(或通道延长段)48。组件42-48中的一些或全部可彼此拆开,并且在使用设备40时进行组装。
中空通道42可具有内表面50,其成形为响应于支架瓣膜10在通道42内从位于一端的入口52向位于相对端的出口54的纵向前进来逐步压缩支架瓣膜10。内表面50的横截面通常为圆形,从而保持压缩期间支架瓣膜10的圆形形状。内表面50可包括一个或多个非圆柱形部分50b和50d,例如,具有沿通道42的纵轴以朝向出口54的方向逐渐减小(例如,收敛)的直径。这样的形状被称为漏斗形。漏斗可具有直的侧面或从侧面看为凹面或凸面。内表面50还可包括一个或多个基本上圆柱形的部分50a和50c。内表面50可进行涂覆以减小表面50和支架瓣膜10之间的摩擦,例如,利用疏水性硅树脂涂层。
在所示的实施方式中,基本上圆柱形的部分50a邻近通道42的入口52。圆柱形部分50a便于支架瓣膜10初始插入通道42中而不进行很大程度的压缩(并且在自膨胀支架瓣膜的情况下,支架瓣膜不存在从入口52回弹的趋势)。此外或作为选择,基本上非圆柱形的部分50d(例如漏斗形)邻近通道42的出口54。非圆柱形部分50d可促进当出现在出口54处时支架瓣膜10末端的收敛(例如,锥形)形状,以便于装载期间支架瓣膜10与传送导管12的支架固定器28的接合。
通道42的出口54可选择地由环形台阶状插槽54a形成,其用于接收传送导管12的护套30的尖端,以便于装载至护套30中。插槽54a可以具有与护套30末端(例如,远端)的外径大体上匹配的内径以将其接纳在内。
通道42的壁至少在径向方向上通常是静止的或固定的。支架瓣膜10的压缩通过在通道42内推进支架瓣膜10来实现,从而支架瓣膜10抵靠内表面50并被迫压缩以沿其前进和/或通过其前进。
推进器44可被配置为将通道42外部产生的纵向驱动力施加至通道42内的支架瓣膜10,从而在通道42内推进支架瓣膜10。推进器44可被配置为将来自通道42径向外部的纵向驱动力施加至支架瓣膜10以在通道42内推进支架瓣膜10。推进器44可包括一个或多个部分(例如,分支)56,其在通道42壁内的相应狭槽58内滑动,并从通道42外部伸出而穿过狭槽58进入通道42内部。(分支)部分56被配置为与支架瓣膜10的部分接合以当推进器44被驱动而纵向平移时推进支架瓣膜10。
利用这样的推进器44施加驱动力会使得驱动力在支架相对端中间的一个或多个位置施加至支架瓣膜。这使得能够施加“推动”力而减小了支架的部分在轴向压缩载荷下弯曲的风险。此外或作为选择,这允许施加力(“牵引”或“推动”)而不干扰支架的末端,也不依赖或利用附接部26。
作为选择,推进器44能够使驱动力施加在支架瓣膜10的末端,而解决了如何推进支架瓣膜(ⅰ)穿过长于支架瓣膜的中空通道和/或(ⅱ)向自身开始压缩的支架瓣膜的部分施加推动力的问题。
此外或作为选择,利用这样的推进器44施加驱动力会使驱动力施加在一个或多个位置(径向和/或纵向),在这些位置,支架相对粗壮和/或更不易于损坏或变形。
在本实例中,驱动力意欲施加至连合支柱22a(参见图2和7)。驱动力“F”可施加在连合支柱22a和连接至各相应支柱22a的对准弓形24a之间的接合处。驱动力可施加在两个相邻弓形24a之间的凹陷38(也被称为谷或凹面)中。利用这样一种技术,推进器44能够在以下位置处接触支架瓣膜10,即(ⅰ)不接触瓣膜组件和裙缘,从而避免对其损坏,和/或(ⅱ)不接触在压缩时被密封的锚定部20的栅格结构。连合支柱22a可提供稳定支撑以接收驱动力,其例如比稳定部24更为坚固。
(分支)部分56可具有与支架瓣膜10接合所需的任意合适的形状和配置。在所示的形式中,每个分支部分56的横截面形状基本上为矩形和/或基本上为平面。分支部分56可具有叶片形式。横截面形状可以提供与支架瓣膜10接触的相对薄和/或平的表面。横截面形状可以限定与支架瓣膜10接触的第一尺寸,其小于通常垂直于第一尺寸的形状的尺寸。
这样的一种或多种形状可以减小分支部分56在支架瓣膜10中挤开一个空间的趋势,同时仍然使分支部分56具有足够的抗弯强度以通过狭槽58向支架瓣膜10传递悬臂形式的驱动力。
在附图所示的形式中,分支56在大体上径向的方向(例如,垂直于通道42的纵轴)向内延伸。作为选择,每个分支部分56可相对于径向方向倾斜。倾斜角度为约5度或更大,可选择地约10度或更大,可选择地约15度或更大,或者可选择地约20度或更大。此外或作为选择,倾斜角度可以不超过约30度,可选择地不超过约25度,可选择地不超过约20度,可选择地不超过约15度,可选择地不超过约10度。当推进器44安装在通道42上时,分支部分56以朝向通道42的出口54的方向倾斜(从而使得分支部分56的内部尖端朝向出口54倾斜,如图3中箭头56a所示)。这样的布置可以阻止或者至少减小在压缩期间支架瓣膜向内弯曲的趋势。反而,倾斜使支架瓣膜朝着表面50适当向外偏斜,表面50的存在阻止了向外弯曲。在其它实施方式中,可利用不同的倾斜角度和/或不同的倾斜方向。而在其它实施方式中,分支56可以在大体径向的方向上向内延伸。
在所示的形式中,分支部分56的径向内部尖端或端部是自由的并且限定了位于其间的空隙。空隙使得当支架瓣膜10装载到传送导管12上作为压缩过程的一部分时能够安置传送导管12的远端部。在其它形式中,分支部分56的内端可耦接在一起。
推进器44可选择地还包括环60,其承载分支部分56,和/或分支部分56从环60开始延伸。环60可围绕通道42的外部适配,并且可沿通道长度的至少一部分纵向滑动(例如,可沿对应于狭槽58范围的至少一部分滑动)。狭槽58可在通道42的至少一端(例如,入口52)打开,以使推进器从通道42分离以在入口引导支架瓣膜10。
通道42可大体上制造为单个构件,其具有在其内形成的狭槽58(如优选实施方式中所示)。作为选择,通道42可包括多个配件,它们可组装在一起以共同限定通道形式。
在一些实施方式中,推进器44可直接用手驱动,但是在优选实施方式中,驱动器46可提供其它便利和控制,用于为推进器44产生并施加(例如,均匀地)驱动力。
驱动器46可关于通道42移动并耦接(或可耦合)至通道42,以响应于施加至驱动器46的相对运动而产生驱动力。驱动器46可位于通道42外部。例如,驱动器46可包括用手或通过利用合适的工具来旋转的旋转构件62。旋转构件62可绕通道42的纵轴旋转。旋转构件62可通过螺纹64和/或螺旋引导件耦接(可耦合)至通道42,以响应于旋转构件62的旋转而产生径向位移。驱动器46(例如,旋转构件)直接或间接地抵靠推进器44(例如,抵靠环),以随着旋转构件62被旋转而向其施加驱动力。(分支)部分56向支架瓣膜10传递驱动力以在通道42内推进支架瓣膜10。
在所示的形式中,通道42具有基本上圆柱形的外部,其带有针对旋转构件62的螺纹64。旋转构件62可例如在通道42的入口52处从螺纹64拧出并拆卸。这样的拧出/拆卸允许移除推进器44以将支架瓣膜插入通道42的入口52,并随后重新安置推进器44和旋转构件62。
如果提供的话,装载管(或通道延长段)48可以包括孔66。孔66的直径对应于传送导管护套30的外径和/或对应于插槽54a的直径。在所示的形式中,装载管48还包括带有固定件70的边缘68,用于可移除地将延长段48附接至通道42,并且使孔66大体上与通道出口54对齐。固定件70可以是内螺纹,用于例如在通道42的出口端与通道42的螺纹64进行螺纹接合。在其它实施方式中,不同的固定件70可用于可移除地将装载管48附接至通道42。在其它实施方式中,不使用固定件,并且代替的是当需要时用手或用某个其它外部固定器将装载管48保持就位。在其它实施方式中,装载管的尺寸大小设定为至少部分地插入通道42的出口内。
如果提供的话,装载管48可以简化传送导管12和通道42之间的协调。在用护套将支架瓣膜的那部分捕获之前,装载管48可以使护套30加固和/或允许支架瓣膜10的至少一部分压缩进入装载管48。可选择地,装载管48可在护套30上滑动。装载管48可向后滑动(远离通道42)以促进附接部26和支架固定器28之间的载荷接合。此后,装载管可向前滑动(朝着通道42)以加固护套30和/或允许支架瓣膜10压缩进入延长段48而不必连续调整护套30以积聚支架瓣膜10的逐渐压缩。
上述组件可由任意合适的一种或多种材料制成,包括金属和/或塑料和/或陶瓷。仅通过实例的方式,通道42、驱动器46、和装载管48可由塑料制成;和/或推进器44的环60可由金属制成;和/或推进器44的分支56可由塑料制成(例如,以避免与支架组件14的金属-金属接触)。在其它形式中,分支56可由金属或陶瓷制成,或者可选择地涂覆或带有塑料覆皮。作为选择,推进器44的环60和分支56可由塑料制成,例如一起整体模制而成。
装载管48和/或通道42可选择地是透明或半透明的,以使操作者能够看到支架瓣膜10在压缩时的状态,并帮助装载和操作传送导管12。
现仅以实例的方式参照图6描述示例性压缩和/或装载过程,其中组件的相对运动方向由箭头序列来指示。
在步骤100,如果提供的话,装载管48当从通道42分离时可在护套30上滑动。装载管48朝着手柄端(32)向后滑动,从而使装载管48不覆盖支架固定器28。护套30也可向后平移以暴露支架固定器28。
仍然在步骤100,在将支架瓣膜10插入通道42之前,驱动器46从通道42拧出并分离。推进器44可以在入口52滑出狭槽58的开放端。此后,可用手将支架瓣膜10插入入口52中。首先插入支架瓣膜10,其端部包括附接部26。在本实例中,首先插入的端部包括锚定部20和/或其下冠20a。支架瓣膜10被旋转定向以使得由推进器对其施加驱动力的支架瓣膜10部分大体上(或至少大致)与狭槽58对齐。在本实例中,这些部分对应于连合支柱22a。入口52处基本上圆柱形的内表面部分50a使支架瓣膜10相对易于插入,而最初不进行很大程度的压缩。
在步骤102,推进器44可在入口52处重新放置,以使得环60适配在通道42外部,并且分支56容纳在狭槽58内并与连合支柱22a的尖端接合(如图7中所示)。
在步骤104,驱动器46可放置在入口52处推进器44的环60上,并且旋转以与螺纹64螺纹接合,并相对于通道42保持支架瓣膜10和推进器44。
此后(仍然在步骤104),驱动器46相对于通道42的连续旋转产生了纵向驱动力,其通过推进器44施加至支架瓣膜10,以将支架瓣膜10推向出口54。随着支架瓣膜10的前进,与内表面50的非圆柱形部分50b和50d的接触将支架瓣膜10逐步压缩至压缩状态。随着支架瓣膜10接近出口54,附接部26首先出现在出口端54。
在步骤106,传送导管的远端可导引进入出口端54(如果还未就位,如下面所解释的那样),直到支架固定器28与暴露的附接部26接合和/或紧密配合为止。能够看到暴露的附接部26从通道的出口端54伸出以便于附接部26与支架固定器28进行接合。出口54处设置内表面50的非圆柱形部分50d促进附接部26从出口54伸出以采用收敛形状,同样促进与支架固定器28的接合。在一些情形中,传送导管的远端可在早期阶段导引进入出口端54,从而使它处于准备接收附接部26的合适位置,或者在从那里出现之前,一旦附接部26开始到达出口端54则导引其进入。
在步骤108,护套30可向远端平移从而覆盖附接至支架固定器28的附接部26,并从而捕获支架瓣膜10的末端。
此后,压缩和/或装载过程的其它步骤取决于是否使用装载管48。如果不使用装载管48,该过程可通过以下步骤逐步进行:驱动器46的步进式旋转(步骤112)以短距离推进支架瓣膜10,每次之后紧接着是护套30朝出口54的相应(向远端)平移(步骤114)以在出口逐步捕获支架瓣膜新暴露的部分。每次,护套30都平移至在插槽54a内接触。
作为选择,如果使用装载管48,则在步骤110,装载管48可沿护套滑动而与通道42的出口端54接触。装载管48可附接至通道42(例如,利用固定件70),或用手保持就位。装载管48可提供增强或控制以避免或减少对随着支架瓣膜10进一步出现在通道42的出口端54而进一步步进式平移护套30的需求。代替地,在步骤112,驱动器46可旋转以推进支架瓣膜10至完全压缩,而不进一步平移护套30。护套30可保持为仅覆盖附接至支架固定器28的附接部26。护套30可远离出口54位移,而始终保持容纳在装载管48内。装载管48可将压缩的支架瓣膜10暂时保持在圆柱形或接近圆柱形的压缩状态。一旦推进器44到达接近出口54的狭槽58端部的最终位置,在步骤114,护套30可再次朝着通道42的出口端54平移,从而将容纳在装载管48内的支架瓣膜10的部分捕获在护套内。应该理解的是,支架瓣膜从装载管48的孔66穿过并进入护套30所需要的额外压缩量是相对较小的,并且容易通过护套30在装载管48内的平移来实现。围绕护套30的装载管48可以加固护套30,而加固是必要的。
利用任一技术,支架瓣膜10大体上实现压缩状态,其中至少大部分锚定部20(以及可选择地至少部分瓣膜支撑部22)被压缩并且装载在护套30内。支架瓣膜10的稳定部24可保持在通道42内。在步骤116,通过向远端滑动设备40而远离传送导管12,设备40从传送导管12和支架瓣膜10脱离。之前还未离开中空通道42的支架瓣膜10的稳定部24的至少一部分倾向于再次展开,这是由于该部分24并未被护套30所限制。然而,稳定部24在径向方向上相对柔韧,并且之后容易被压缩而不需要中空通道42,如下面所解释的那样。
装载过程的最后阶段(未在图6中示出,因为这些并不直接与设备40相关)可包括下面的一个或多个:
(ⅰ)移除传送导管12的装载尖端34并更换为植入尖端;以及
(ⅱ)进一步向远端平移护套30以压缩稳定部24。护套30可平移至与传送尖端接触,以封闭传送导管12准备用于植入的远端区域。
图8至14示出了示例性包装120,其中对传送导管12进行存储、运输、并提供至传送导管12待用的位点。传送导管12的位置在图14中示出。包装120可选择地还包含设备40(在图9、10、13和14中),用于压缩和/或装载支架瓣膜10。设备40可具有、或包括上述实施方式的任意特征。
包装120通常包括底座122和盖(例如,盖子)124,其用于覆盖底座122以使包装120封闭。底座122包括水槽126,用于至少部分地容纳传送导管12。在所示出的实施方式中,水槽126的尺寸大小设定为能够大体上容纳整个传送导管12。
该实施方式的一个特征在于,水槽126基本上为液密的,并可用于保持液体,在进行操作以关于传送导管12压缩和/或装载支架瓣膜10时支架瓣膜10和/或传送导管12的内含区域12a浸入其中。可选择地,另一特征在于,相同的水槽126用于将传送导管12保持在(ⅰ)最初提供传送导管12的包装120中的存储位置,以及(ⅱ)用于将支架瓣膜10装载在传送导管12上的装载位置。可选择地,存储位置和装载位置可大体上彼此相同。在至少一个位置(或者两个位置,视情况而定),传送导管12当用于装载支架瓣膜时大体上平行于底座的平面,和/或大体上水平。将传送导管12布置为大体上平行于底座平面能够使包装的高度期望地保持为很小。将传送导管12布置为在装载支架瓣膜期间使用时大体上平行于底座平面和/或大体上水平,能够(ⅰ)使填满水槽所需的液体量期望地保持为很小,和/或(ⅱ)减少了装载操作期间传送导管内不可避免滞留的空气量。滞留空气应当在导管插入患者身体前去除,并且在装载期间减少可能滞留的空气量能够减轻随后“排气”步骤的负担。
水槽126可具有均匀的深度,或者它可具有沿其长度变化的深度。至少在压缩和/或装载支架瓣膜10,或者安置传送导管12的内含区域12a的区域126a中,水槽126具有大于支架瓣膜10和/或装载设备40的横向尺寸的深度。例如,区域126a中的深度可以是:至少1cm;至少2cm;至少3cm;至少4cm;至少5cm;至少6cm;至少7cm;至少8cm;至少9cm;至少10cm;至少11cm;至少12cm;至少13cm;至少14cm;至少15cm。
水槽126可以具有均匀的深度,或者它可具有沿其长度变化的宽度。
在一些实施方式中,水槽126包括一个或多个第一表面部128,其共同限定了符合部分传送导管12的形状以支撑导管防止很大程度的运动的插槽。此外或作为选择,水槽126包括一个或多个第二表面部130,其共同限定了邻近传送导管的部分12b的间隙130a,传送导管的部分12b用于用手握持或使用以操纵导管和/或平移护套。此外或作为选择,水槽126包括一个或多个表面部130,其限定了针对区域126a的间隙。在一些实施方式中,水槽126包括一个或多个第一表面部128和一个或多个第二表面部130,从而第二表面部130允许用手使用以操纵护套,而传送导管12处于由第一表面部128所限定的位置。
水槽126的底座通常是平的(可选择地具有圆角)和/或水槽126的至少部分底座可以被成形为从下部支撑或容纳传送导管和/或装载设备。
水槽126的液体容量可通过设计来选择。在一些实施方式中,液体容量使得(可选择地,传送导管12和/或装载设备40在水槽126内就位)水槽126的液体量选自以下中的一个或多个:不超过4升;不超过3.5升;不超过3.25升;不超过3升;至少1升;至少2升。例如,当传送导管12和装载设备40放置在水槽126中时可以测量液体量。
盖124可选择地包括一个或多个突起132,例如一个或多个脊,其从盖124下垂并与水槽126紧密配合和/或接合(ⅰ)传送导管12和/或(ⅱ)装载设备40,以保持传送导管/装载设备束缚在水槽内。突起132可具有轮廓134,例如凹形,被配置为容纳传送导管/装载设备的表面。
装载设备40可选择地包含在不同于水槽126的隔间内,或者它可保持在水槽126为此而保留的区域136中。如上面所述,装载设备40可以由盖124(或者盖的突起132)限制就位。
底座122还可以包括一个或多个不同于水槽126的隔间,用于容纳配件。
底座122和/或盖124可由任意合适的一种或多种材料制成,例如,塑料。底座122和/或盖124可由任意合适的技术形成,例如,吹塑或注射成型。
利用包装120的示例性步骤包括以任何顺序的下列步骤的一个或多个:
(a)提供封闭形式的包装120,包含传送导管12和/或装载设备;
(b)打开包装120(例如,移除盖124);
(c)将液体引入水槽126;以及
(d)将支架瓣膜装载至传送导管12的内含区域12a,同时至少支架瓣膜和/或内含区域12a浸入水槽的液体中。例如,设备40可置于传送导管12的尖端上,并且在水槽126的区域126a内操作。
液体例如可以是生理盐水。液体可以比体温更冷。例如,液体可处于大约室温。
步骤(d)可利用大体上水平的传送导管12来执行。
该方法还可以包括在装载操作之后从传送导管12中移除滞留空气的步骤(例如,“排气”步骤)。如上面所述,利用大体上水平的传送导管执行步骤(d)会减少装载操作期间滞留的空气量。
步骤(d)可包括以上关于附图中的图6所述的步骤。
前面的说明仅仅是本发明优选实施方式的示例并且不限制保护范围。可以在本发明的范围内利用许多等同物、修改和改进。
Claims (14)
1.一种用于压缩经导管心脏内支架瓣膜(10)的设备(40),该设备包括:
中空通道(42),具有成形为响应于支架在所述中空通道内的纵向前进而逐步压缩所述支架瓣膜的内表面(50),所述中空通道包括至少一个穿过其壁的狭槽(58);以及
推进器(44),包括装配在所述中空通道的圆周外围的部分(60)和能在所述狭槽内滑动并穿过所述狭槽伸出以接合所述中空通道内的支架瓣膜的部分(56),所述推进器用于将来自所述中空通道径向外部的纵向驱动力施加至所述支架瓣膜。
2.根据权利要求1所述的设备,其中所述中空通道(42)包括多个所述狭槽(58),以及其中所述推进器包括相应数量的能在所述狭槽内滑动并穿过所述狭槽伸出以接合所述中空通道内的支架瓣膜的部分(56)。
3.根据权利要求2所述的设备,其中装配在所述中空通道圆周外围的所述推进器的部分(60)在所述中空通道外部径向互连。
4.根据权利要求2或3所述的设备,其中装配在所述中空通道的圆周外围的部分包括环(60),以及其中能在所述狭槽内滑动的部分包括从环向内延伸的相应分支(56)。
5.根据权利要求1或2所述的设备,还包括驱动器(46),其能够安装在所述中空通道(42)的径向外部,并且可操作地产生相对于所述中空通道(42)的径向驱动力并通过所述推进器(44)将来自通道径向外部的纵向驱动力施加至所述中空通道(42)内的支架瓣膜。
6.根据权利要求1或2所述的设备,还包括驱动器(46),其通过螺纹(64)耦接至所述中空通道(42)的外部,用于响应于所述驱动器的旋转来产生纵向驱动力。
7.根据权利要求1或2所述的设备,其中所述中空通道具有入口(52)和出口(54),所述入口具有大于所述出口的孔直径,并且所述设备还包括装载管(48),所述装载管(48)用在所述出口处或者至少部分地插入所述出口,所述装载管具有用于接收以下的孔:(ⅰ)要装载所述支架瓣膜的传送导管的护套的至少一部分;和/或(ⅱ)所述支架瓣膜的至少一部分。
8.根据权利要求1或2所述的设备,其中所述中空通道具有入口(52)和出口(54),所述入口具有大于所述出口的孔直径,以及所述设备还包括装载管(48),所述装载管(48)可移除地附接至所述中空通道,所述装载管的内部具有直径约等于所述中空通道的出口处的孔直径的孔,以限定所述中空通道的延长段。
9.根据权利要求1或2所述的设备,其中装配在中空通道圆周外围的推进器(44)的部分(60)被定尺寸为至少沿所述狭槽(58)的整个长度保持在圆周外围。
10.根据权利要求9所述的设备,其中装配在中空通道圆周外围的推进器(44)的部分(60)具有大于所述狭槽(58)的圆周宽度的周向尺寸。
11.根据权利要求1或2所述的设备,还包括:
传送导管,用于将支架瓣膜传送至体内的植入位点,所述传送导管在内含区域具有至少一个可平移的护套,用于接收压缩形式的支架瓣膜,其压缩形式源于用于针对所述传送导管来压缩和装载所述支架瓣膜的装载操作;
包装,用于在使用前容纳所述传送导管,所述包装包括具有液密水槽的底座,所述水槽具有适用于容纳液体的深度,在所述装载操作期间导管的内含区域可被浸入在该深度内。
12.一种压缩经导管心脏内支架瓣膜(10)的方法,包括下述步骤:
(a)提供具有入口(52)和出口(54)的中空通道(42),所述中空通道还具有成形为响应于所述支架瓣膜在通道内的纵向前进而逐步压缩所述支架瓣膜的内表面(50);
(b)在所述通道的入口处插入所述支架瓣膜(10);以及
(c)施加来自通道径向外部的纵向驱动力以在所述通道内将所述支架瓣膜推向所述出口。
13.根据权利要求12所述的方法,还包括以下步骤:
(d)将出现在所述出口处的支架瓣膜(10)的一部分耦接至传送导管的支架固定器;
(e)再次向所述支架瓣膜施加驱动力以在所述中空通道内进一步推进所述支架瓣膜;
(f)平移所述传送导管的内含护套以在其内捕获由于步骤(e)而出现在所述出口处的所述支架瓣膜的一部分。
14.根据权利要求13所述的方法,还包括顺序地重复步骤(e)和(f)。
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