CN103945793A - 用于主动脉腔内修复的装置及其使用方法 - Google Patents
用于主动脉腔内修复的装置及其使用方法 Download PDFInfo
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- CN103945793A CN103945793A CN201280057751.6A CN201280057751A CN103945793A CN 103945793 A CN103945793 A CN 103945793A CN 201280057751 A CN201280057751 A CN 201280057751A CN 103945793 A CN103945793 A CN 103945793A
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Abstract
本发明公开了一种用于患者的主动脉腔内修复的装置和方法,所述装置包括一支架组件,所述支架组件包括一球囊扩张支架,以及固定到球囊扩张支架上的自膨胀支架。所述装置还包括一安置在支架组件近端的瓣膜元件。所述装置还包括可固定到支架组件上的另一个假体部件。所述假体部件可包括至少一个导管配置用来接收覆膜支架。
Description
相关申请的交叉引用
本申请要求根据美国法典35 §119的序列号为61 /567,458,名称为“用于主动脉腔内修复的主动脉瓣反式导管”的美国临时专利申请的优先权,其由阿里·沙里亚在2011年12月6日提交,其内容被明确地纳入本文参考。本申请同样要求根据美国法典§119的序列号为61/723,446,名称为“用于主动脉腔内修复的主动脉瓣反式导管”的美国临时专利申请的优先权,其由阿里·沙里亚在2012年11月7日提交,其内容被明确地纳入本文参考。
技术领域
本发明涉及一种用于主动脉腔内修复的装置和使用该装置的方法,包括修复主动脉瓣病变,主动脉瓣狭窄,升主动脉瘤,主动脉瓣关闭不全,主动脉瓣返流,升动脉瘤,二尖瓣病变,和/或A型夹层(夹层动脉瘤)。
背景技术
正常的主动脉根部和升主动脉是由主动脉瓣环、主动脉窦、窦管连接处以及管状部分构成的,对于升主动脉瘤腔内修复的从业者所面临的挑战是在窦管连接处的平面上有一个很短的近端锚定区,且病人之间有可变的冠状动脉解剖,而且在许多情况下,存在着主动脉瓣或狭窄或不全的情况。一般来说,如手术见解的文章中提到的,由詹姆斯E·戴维斯和思罗尔M·斯坦特在自然临床实践心血管内科(2007)上发表的名称为扩张的升主动脉-手术干预的迹象的文章,其中的全部内容纳入本文参考,其中涉及三种基本类型的升主动脉,称为A,B或C型。上述将在下面更详细的讨论,并示于已从引用的文章转载的图1A~1C中。
A型动脉瘤最常见于年轻患者,和具有结缔组织疾病例如马凡综合征的患者。A型动脉瘤结构上的特点是主动脉窦扩张伴有或者没有主动脉环面的扩张。窦管连接处有最常见的扩张。该瓣膜可能是正常、狭窄或不足的。如图1A所示的是一种A类型的动脉瘤的例子。
B型动脉瘤结构上的特点是管状部分的扩张。最初时窦管连接处可能正常或轻度扩张,然而由于动脉瘤生长,它延伸至窦管连接处,最终可能导致主动脉瓣关闭不全。该瓣膜可能是正常、狭窄或不足的。动脉瘤的主体在管状主动脉平面上。如图1B所示的是一种B型动脉瘤的一个例子。
C型动脉瘤结构上的特点是主动脉窦、窦管连接处以及主动脉的管状部分扩张。该瓣膜可能是正常、狭窄或不足的。B和C型动脉瘤是在老年组患者最常见的。如图1C所示的是一种C型动脉瘤的一个例子。
现已有一些临床用于升主动脉瘤腔内修复的设备。虽然反式导管瓣膜是一个临床事实,没有在临床使用中已经设计了用于多种类型的升主动脉瘤的腔内修复。实际上,可以治疗不同变化结构的升主动脉瘤的装置是必要的,建立有效的近端和远端主动脉内密封区域,具有一个耐用的瓣膜组件,但也允许未来的瓣膜再次干预,同样需要一种装置来治疗患者群体中不同的冠状动脉结构上的变化,允许未来的冠状动脉再介入,但是需要避免损害冠状动脉,并且能够处理可能的瓣周漏。
发明内容
根据本发明的一个方面,本发明公开了一种用于升主动脉瘤腔内修复的移植物装置。所述移植物装置包括具有近端框架和远端框架的第一假体部件,所述远端框架固定在近端框架上并延伸至第一假体部件的远端。所述移植物装置也至少包括一固定在第一假体部件上并靠近近端框架的导管,还包括固定在第一假体部件近端的第二假体部件。所述第二假体部件包括从第二假体部件的近端向远端延伸的球囊扩张支架,还包括连接到球囊扩张支架并延伸到第二假体部件远端处的自膨胀支架。所述移植物装置还包括固定在第二假体部件近端的球囊扩张支架上的瓣膜元件。
在一些实施例中,所述自膨胀支架可具有沙漏状。在一些实施例中,所述自膨胀支架可包括在近端和远端之间向内渐缩的第一部件,所述移植物装置可包括第二部件,其近端固定于第一部件的远端。第二部件可以在第二部件的近端和远端之间向外逐渐变细。此外,在一些实施例中,第一部件的近端可连接到球囊扩张支架的远端。
在一些实施例中,所述自膨胀支架可包括从第一部件的近端向近侧延伸的第三部件。第三部件可以具有设定在其中的通道,并且球囊扩张支架可定位在自膨胀支架第三部件中的通道中。在一些实施例中,球囊扩张支架可在其外表面与自膨胀支架的内表面分开时的未展开状态和球囊扩张支架的外表面与自膨胀支架的内表面配合时的展开状态之间扩展变化。
在一些实施例中,多根纤维可以附着到自膨胀支架的第三部件。当球囊扩张支架在展开膨胀的位置时,球囊扩张支架的外表面与多根纤维接合。
在一些实施例中,第一个假体部件的近端框架可以具有设定在其中的通道,第二假体部件的远端可以定位于第一假体部件的通道中。
在一些实施例中,所述导管可包括定位在第一假体部件相对侧的一对导管。此外,在一些实施例中,所述导管可以有一个被定位于靠近第一假体部件近端的近端开口。
在一些实施例中,近端框架可以包括固定到第二假体部件远端的第一部件,以及与第一部件连接的第二部件。所述第二部件可以在连接到第一部件的近端和远端之间向外逐渐变细。所述导管可具有在近端框架的第二部件中设置的一个远端开口。
此外,在一些实施例中,所述移植物装置可包括一个远端定位在至少一个导管的近端开口,以及近端被设置在冠状动脉中的支架。
在一些实施例中,所述第二假体部件的外表面和第一假体部件近端框架的外表面可被覆盖,以防止流体流过。此外,第一假体部件远端框架的外表面可未被覆盖,使得流体被允许通过。
根据另一方面,本文公开了一反式导管瓣膜。所述反式导管瓣膜包括一框架组件,其具有从所述框架部件的近端向远侧延伸的球囊扩张支架,以及固定到所述球囊扩张支架上的自膨胀支架。所述自膨胀支架包括在近端和远端之间向内逐渐变细的第一部件,以及在远端和连接到第一部件的近端之间向外逐渐变细的第二部件。一瓣膜元件被定位在框架组件近端的球囊扩张支架上。
在一些实施例中,所述框架组件可包括一双框架组件。所述自膨胀支架可作为双框架组件的外层框架,并且可以具有限定在其中的通道。所述球囊扩张支架可作为双框架组件的内层框架,且被定位在自膨胀支架设置的通道中。此外,所述球囊扩张支架可在其外表面与自膨胀支架的内表面分开时的未展开状态和球囊扩张支架的外表面与自膨胀支架的内表面配合时的展开状态之间扩展变化。
在一些实施例中,多根纤维可以附着到自膨胀支架上。当球囊扩张支架在展开的位置时,球囊扩张支架的外表面与多根纤维接合。此外,在一些实施例中,自膨胀支架的第一部件的外表面不被覆盖,以使得流体可从其中通过;自膨胀支架的第二部件的外表面被覆盖,以防止流体流过。
在一些实施例中,所述自膨胀支架可包括从第二部件向远侧延伸的延长部分。所述延长部分的长度可大于所述第一部件和第二部件的组合长度。此外,在一些实施例中,自膨胀支架可被覆盖有胶原或水凝胶中的至少一种。在一些实施例中,所述瓣膜元件可以是二尖瓣和三尖瓣中的一种。
根据另一方面,本文公开了一种修复患者主动脉的方法。所述方法包括引入第一假体部件进入患者的主动脉,以使第一假体部件的近端框架被定位在升主动脉,其远端框架被定位在患者主动脉的主动脉弓,本文提供了一个通过第一假体部件中设置的导管到患者主动脉的冠状动脉的覆膜支架,确保了第二假体部件固定到患者主动脉的第一假体部件的近端,扩张了第二假体部件的近端部分进入患者主动脉的主动脉瓣环与之配合,这样固定到近端部件的一瓣膜定位在冠状动脉附近的主动脉瓣环上。
在一些实施例中,扩张第二假体部件近端部分可包括操作球囊扩张支架。此外,在一些实施例中,第二假体部件近端部分的扩张可包括允许自膨胀支架扩张到与主动脉环接触,操作球囊扩张框架可包括在自膨胀支架与主动脉环接触之后,促进球囊扩张支架的外表面与自膨胀支架的内表面接触。
在一些实施例中,操作所述球囊扩张支架可包括促进球囊扩张支架的外表面与主动脉环配合。
在一些实施例中,第二假体部件的外表面和第一假体部件的近端框架的外表面可被覆盖以防止流体流过。此外,第一假体部件的远端框架的外表面可不被覆盖使得流体可通过。
在一些实施例中,可以在第一外科手术过程期间引入第一假体部件到患者的主动脉和提供覆膜支架穿过第一假体部件中设置的导管到患者主动脉的冠状动脉。在一些实施例中,可以在与第一外科手术过程不同的第二外科手术过程中实施固定第二假体部件到第一假体部件的近端和扩张第二假体部件的近端部分与患者主动脉的主动脉环配合。
在一些实施例中,所述方法包括在引入第一假体部件之前,引入第二假体部件到升主动脉。
附图简要说明
本发明的实施例现在将通过示例的方式参照附图更详细的描述,其中:
图1是一个用作说明的主动脉。
图1A是A型动脉瘤的示例。
图1B是B型动脉瘤的示例。
图1C是C型动脉瘤的示例。
图2是一种血管内假体装置置入其中的主动脉的局部剖视图。
图3是图2中的血管内假体装置的近端假体部件的正视图。
图4是图2中的血管内假体装置的远端假体部件的正视图。
图5是图4中的远端假体部件的横截面图(沿图4中的线5-5剖取)。
图6是一个内部置入如图3所示的远端假体部件的主动脉的局部剖视图。
图7是一个类似于图6所示的从远端假体部件延伸的支架。
图8是图2所示的血管内假体装置的一近端假体部件的另一个实施例的正视图。
图9是图8所示的近端假体部件的自膨胀支架外层框架的正视图。
图10是图8所示的近端假体部件的球囊扩张支架内层框架的正视图。
图11为图8所示的近端假体部件近端的透视图。
图12是图8中的近端假体组件的剖视图(沿图11中的线12-12剖取)。
图13是图8所示的近端假体部件的平面图,其中显示了其内层框架在未展开(扩张)的位置。
图14是于图13类似的平面图,显示了其内层框架在展开的位置。
图15是将图4所示的远端假体部件固定到图8所示的近端假体部件的主动脉的局部剖视图。
图16与图15类似,示意出了在展开位置的内层框架。
图17是一个类似于图3所示的近端假体部件的反式导管瓣膜装置的一个实施例。
图18-19是如图17所示的反式导管瓣膜置入主动脉的局部剖视图。
图20是类似于图8所示的近端假体部件的反式导管瓣膜的另一个实施例。
图20-21是如图20所示的反式导管瓣膜置入主动脉的局部剖视图。
具体实施方式
本发明的概念有不同的修改和替代形式,具体的示例性实施例以附图示例的方式被示出,并且将在本文中详细地描述。然而,应当理解的是,没有意图将本发明的原理限制到所公开的特定形式,而是相反,其意图在于涵盖在本发明的精神和范围内由所附权利要求书所限定的所有修改、等同物和替代物。
代表结构上的参考术语,例如前、后、中间、侧面、上、下、远端、近端,等等,关于本文描述的整形外科置入物和手术器械以及参考患者的自然解剖结构,这些术语也可使用在整个说明书中。这些术语在解剖学和整形外科领域有很好的理解的意义。除非另有说明,在说明书和权利要求这样的结构参考术语的使用是与它们的理解的含义一致。例如,术语“近端”指的是通常是最靠近心脏的方向,而术语“远侧”指的是一般与心脏最远的方向。
参考图2-16示意的血管内假体装置或移植物装置10(以下为装置10)的示例性设计。所述装置10是用于大多数升主动脉瘤的治疗,并且无论主动脉瓣和主动脉窦是否参与,装置10被配置用于治疗任何类型的升动脉瘤。以下更详细的讨论,所述装置10允许未来的冠状动脉和主动脉瓣的干预以及延伸开窗/分支接枝到主动脉弓。如图17-22所示将会更详细的描述,所述装置10的一部分可以被改动并用作反式导管瓣膜,这样一个瓣膜的引入可以是变化的或通过锁骨下动脉或心脏的心尖。
现在参照图2-7,所述装置10包括连接到远侧部件14的近侧部件12。如图2中所示,当被置入患者的主动脉16时,所述远端部件14可以固定到近端部件12。当被置入时,所述近端部件12被定位在患者的升主动脉18,而远端部件14向远端延伸到病人的主动脉16的弓20 。所述远端部件14包括一对内切卡布罗尔管道或者导管22,每个导管22的大小用于冠状动脉的血流量以容纳支架或导管24,如下将更详细的描述。所述装置10被配置为处理所有的带有或不带有扩张窦管结和主动脉瓣疾病的升主动脉瘤。
如图3所示,所述近端部件12包括一从近端28延伸到远端30的框架26。所述框架26连接到瓣膜32(虚线所示),其被定位在近端部件12的近端28。在说明性实施例中,该瓣膜32被配置为二尖瓣。应当理解在其他实施例中,瓣膜32可以是三尖瓣或正方形尖瓣。所述瓣膜32可以由处理过的牛心包膜或其他适当的试验生物的或合成的材料制造。当近端部件12被置入患者的主动脉16时,所述瓣膜32替换主动脉瓣和允许流体(即,血)选择性地从心脏流到通过近端部件12延伸的通道36。
所述瓣膜32被容纳在框架26的球囊扩张型框架34上。如图3所示,球囊扩张型框架34体现为球囊扩张支架38,其从近端部件12的近端28向远侧延伸,并具有大约15mm的长度40。在其它的实施例中,所述支架38可根据例如患者的解剖结构可长可短。所述支架38是管状的,并且由如镍钛合金,不锈钢,或其它置入级金属材料制造成一个开孔的单元结构。应当理解在其他实施例中,支架38可以由聚合物材料形成,并且可以形成,例如,一个Z型支架的配置。在说明性的实施例中,支架38的外表面42覆盖有低剖面的聚酯,聚四氟乙烯,或其他无孔的覆盖材料44,以防止流体通过外表面42。然而,应当理解的是,支架38可以覆盖有标准聚酯或其它无孔材料。
如图3所示,所述球囊扩张型框架34的支架38有一个直径46。如下面更详细描述的,球囊扩张型框架34在从未扩张直径(未示出)到扩张的直径46的置入过程中是可膨胀的。在说明性实施例中,当框架34膨胀时扩张直径46大约等于26mm。在其它的实施例中,所述扩张的直径可以大于或小于26mm取决于,例如,患者的解剖结构。球囊扩张支架的例子在由胡里奥·C.·帕尔马的美国专利号5,102,417题为“扩张腔内移植物,用于置入扩张腔内移植物的方法和装置”及亨宁·如德·安德森等人的美国专利号6,582,462题为“人工瓣膜置入体和置入例如瓣膜假体的导管”。上述内容是明确纳入本文参考的。在说明性的实施例中,直径46相对于主动脉瓣环210(见图1)大很多,因此当部件12被置入和支架38被扩张时,使得支架38和主动脉瓣环210过盈配合,这将在下文更详细的描述。
所述球囊扩张型框架34连接到自膨胀支架50上。在用作说明的实施例中,球囊扩张型框架34的远端52通过缝合或缝框架34,50在一起而固定到支架50的近端54,因此形成部件12的框架26。应当可以理解的是在其它的实施例中,框架34,50可通过焊接或其它的紧固件被一起固定。所述框架34,50也可以形成为一个单一的,整体式框架。
如图3所示,自膨胀支架50为常见的沙漏状,并且由例如镍钛合金,不锈钢,或其它置入级金属材料制成。应当可以理解的是,在其它的实施例中,支架50可有聚合物材料制成。所述支架50包括一个向内的锥形近端部分60,一个向外锥形中间部分62,以及延长的远端部分64。所述部分60包括支架50的近端54和连接到向外锥形中间部分62近端68的远端66 。所述部分60在端部54,66之间向内逐渐变细,从约26mm的端部54到约22mm的端部66。在示例性实施例中,近端部分60具有大约10mm的长度70。应当可以理解的是,在其它的实施例中,所述近端部分60的尺寸可以根据,例如,患者的解剖结构变化。
所述自膨胀支架50的向外锥形中间部分62具有近端68和连接到延长的远端部分64近端74的远端72。所述部分62从大约22mm直径的末端68到大约直径28的末端72向外逐渐变细。在示例性的实施例中,所述中间部分62具有大约10mm的长度76。在其它的实施例中,所述部分62的尺寸可根据例如,患者的解剖结构变化。在其它的实施例中,所述近端部件12的锥形部分60,62允许安放从远端部件14延伸到冠状动脉的支架24,这将在下文更详细的描述。
所述自膨胀支架50延长的远端部分64从近端74向远侧延伸到部件12的远端30。在示例性的实施例中,所述部分64的长度78大于锥形部分60,62的组合长度。在一个特定的非限制性例子中,所述延长的远端部分64的长度78大约为25mm,其直径80大约为28mm。在其它的实施例中,所述部分64的尺寸可根据例如,患者的解剖结构变化。在一个示范性的实施例中,所述远端部分64在近端74和远端30之间可能逐渐变细。
如图3所示,所述自膨胀支架50的近端部分60在一个开孔的结构形成,所述部分62,64形成在Z支架结构中。应当可以理解的是在其它的实施例中,所述部分60,62,64可以形成为一个单一的结构,包括一开孔的支架结构或Z支架结构。所述部分60,62,64可以形成为一个单一的整体结构。所述自膨胀支架50的外表面82覆盖有低剖面的聚酯,聚四氟乙烯,或其他无孔的覆盖材料84,以防止流体通过表面82。这样,部件12的整个外表面被覆盖以防止流体从中通过。所述球囊扩张型框架34远端的覆盖材料84配备有“陷阱门”86,其可打开以允许用于潜在瓣周漏栓塞的一个或多个外科手术器械的通过。部件12的整个外表面被覆盖有低剖面的涤纶或其他合成材料。可以理解的是部件12的所有或者部分可被覆盖有水凝胶或者其它密封材料。
如上面描述的,所述装置10可包括一远端部件14,当装置10被置入患者的主动脉16时,所述远端部件14被固定在近端部件12的远端30上。现参考图4,远端部件14包括一从近端102延伸出的框架100,其被配置为固定在近端部件12上到远端104。所述框架100有一个设在其中的通道106,其延伸通过部件14的端部102,104。所述通道106有一直径108,当装置10被组装时,其大小以接收近端部件12的远端30。
在用作说明的实施例中,所述部件12,14通过框架100和近端部件12的远端30之间的过盈配合而被固定在一起。具体来说,通道106的直径108小于近端部件12的直径80。
在用作说明的实施例中,所述直径108大约为26mm。应当可以理解的是在其它的实施例中,部件12,14可通过缝合或其它紧固方式来被固定在一起。
如图4所示,所述部件14包括一连接到延长的远端框架112的近端框架110。所述近端框架110和远端框架112由金属材料制成,例如,镍钛合金,不锈钢,或其它置入级金属材料。应当可以理解的是在其它的实施例中,所述框架110,112可由聚合物材料制成。所述近端框架110形成为Z-支架的配置,以及远端框架112形成为一个开孔的支架结构。每一个框架110,112都是自膨胀的。在示例性的实施例中,所述远端框架112通过缝合或者缝合框架110,112被固定在近端框架110的远端114。应当可以理解的是在其它实施例中所述框架110,112可通过焊接或其它的紧固件而被固定在一起。所述框架110,112可形成为一个单一的,整体式框架。
所述近端框架110具有覆盖着低剖面聚酯,聚四氟乙烯,或在其它无孔覆盖材料122的外表面120。因此,流体被阻止不能通过所述外表面120。所述远端框架112未被覆盖因此流体可被允许通过在其中形成的开口124。
如图4所示,所述近端框架110包括一近端部分126,一个从近端部分126向远侧延伸的向外的锥形部分128,以及延长的远端部分130。所述近端部分126包括部件14的近端102和连接到向外锥形部分128近端134的远端132。在用作说明的实施例中,所述近端部分126具有大约为25mm的长度136。应当可以理解的是在其它实施例中部分126的尺寸可根据,例如患者的解剖结构而变化。
所述框架110锥形部分128具有近端134和连接到延长远端部分130的近端142的远端140。所述部分128从直径约26mm的端部132到约44mm-48mm直径的端部140向外逐渐变细。在用作说明的实施例中,锥形部分128具有约10mm的长度146。应当可以理解的是在其它实施例中部分128的尺寸可根据,例如患者的解剖结构而变化。
所述框架110的延长的远端部分130从近端142到所述框架110的远端114向远侧延伸。在示例性的实施例中,所述部分130具有长度150。在一个特定的非限制性的例子中,所述延长的远端部分130的长度150约为20mm。所述部分130同样具有约为44-48mm之间的直径152。在其它的实施例中,所述部分130的尺寸可根据,例如患者的解剖结构而变化。
如上描述的,所述远端部件14同样具有一对导管22,其连向近端框架110。每个导管22具有固定到所述框架110的锥形部分128的远端160,以及一定位在靠近部件12近端102的近端162。如图4所示,所述导管22不会延伸超出该部件12的近端102。每个导管22具有一通道164延伸穿过端部160,162,其尺寸为用于接收支架24。
所述通道164具有设置在端部162的近端开口166。所述开口166有一个直径168,在示例性实施例中等于约5mm。如图5所示,所述通道164具有设置在端部160以及所述框架110的锥形部分128的远端开口170。所述远端开口170具有大于直径168的直径172。在示例性实施例中,所述直径172约为8mm。所述通道164的尺寸约为直径8mm超过174约5mm的距离,并且渐缩平滑地进入在结176处大约5mm的直径168。所述通道164保持结176和近侧开口166之间的直径168。在示例性的实施例中,所述通道164具有在结176和近端开口166之间的约为2cm的长度180。
每个导管22是金属丝增强的,无论部署方向如何,允许导管或支架24进入和使得冠状动脉开口的插管更容易,这种结构允许冠状动脉182在部件12配置之前置入支架(见图1),如在下面更详细地描述。在示例性的实施例中,锥形部分128允许支架24具有无损害通道进入冠状动脉182,这样在窦管结和装置10之间的所述支架不被压缩。
如图4所示,所述部件14延长的远端框架112从框架110的远端114 向远侧延伸到部件14的远端104。在示例性实施例中,所述框架112具有长度190。在一个特定的非限制性实施例中,所述延长的框架112长度190约为10cm,被置入其中时足以覆盖主动脉18的弓20。在其它的实施例中,所述框架112的尺寸可根据,例如患者的解剖结构而变化。所述远端框架112允许部件14的准确部署而不影响到主动脉弓分支的循环。如果一个开窗/支拱的装置是必要的,它同样允许主动脉弓分支的插管。
置入装置10在病人的主动脉16,一外科医生可得到暴露的或者经皮进入的普通股动脉。髂动脉或髂导管也可以使用。在获得入口并把坚硬的钢丝放置在升主动脉18后,准备所述装置10和输送系统。在示例性的实施例中,所述输送系统是由一个100 - 105厘米的亲水性护套组成。如图6所示,所述远端部件14首先被输送。在进行侧倾斜胸主动脉造影后,所述部件14被部署,使得近端框架110的远端114定位在靠近无名动脉200,因此确保了导管22的远端开口170在12-6点钟位置与无名动脉200联系。
使用对侧常用的股动脉线,标准的冠状动脉引导导管通过部件14的远端框架112引入到每个导管22。所述导管22在支架24插入之前可与导管插管。或者,可以预先插管所述导管22,利用这些导管,可以接近左右冠状动脉182。如图7所示,所述支架24通过远端开口170进入通道164,并从导管22出来桥接动脉182和导管22。那样,每个动脉182连接到各自的导管22。每个支架24被覆盖,并且表现为一个球囊扩张支架或自膨胀支架。应当可以理解的是,在放置所述部件14之前冠状动脉支路可被分为左和右冠状动脉系统。
所述近端部件12在远端部件14置入后可被利用。所述部件12,14可被安排为一个实施在同一天的外科手术程序,或者所述部件14可被安排为一个程序,并且所述部件12可在以后被安排为另一个分开的程序。如图1所示,所述近端部件12被安排定位在穿过主动脉瓣202的位置。
这样做,坚硬的钢丝穿过主动脉瓣202传递到左心室204中。所述近端部件12的输送系统穿过瓣膜202。输送系统的一个例子描述在胡里奥C.帕尔马的美国专利号5,102,417题为“扩张腔内移植物,用于置入扩张腔内移植物的方法和装置”文中,上述是纳入本文参考的。当输送系统在适当的位置时,所述近端部件12通过拔出系统释放,从而允许自膨胀支架50扩张。如上所述,自膨胀支架50确保远端部件14的近端102将部件12,14固定在一起,以及密封远端部件14内的部件12的远端30。如图2所示,近端部件12的近端28被定位在主动脉环面,并且所述部件12的沙漏形状为主动脉瓣叶提供了一个空间,使得叶片不被压住或者越过冠状动脉的开口182。
通过将在所述输送系统里的球囊膨胀来展开所述球囊扩张框架34。展开所述框架34到预定的膨胀直径46,以及促进框架34进入与主动脉瓣环210配合,因此密封主动脉瓣环210使得流体被允许仅通过瓣膜32流过左心室204,如图1所示,所述瓣膜32被定位在靠近冠状动脉182的主动脉瓣环210。应该可以理解的是,所述部件12的展开可以在快速心室起搏(RVP)期间进行。在主动脉瓣狭窄的情况下,所述瓣膜32可在引进近端部件12之前随着球囊血管成形术膨胀。
参考图8-16示意出了所述装置10的近端部件212的另一个实施例。图8 - 16中所示的实施例中的某些特征类似于如上所述的参考图1-7中的实施例描述的。这些特征被指定在图8 – 16中使用与图1-7中相同的参考号。类似于图1-7中的近端部件12,当置入患者的主动脉16中时,所述近端部件212可被固定到远端部件14。当被置入时,所述近端部件212被定位在患者的升主动脉18,而远端部件14向远端延伸到患者主动脉16的弓20 。
如图8所示,所述近端部件212包括一从近端28延伸到远端30的双框架214。所述框架214连接到瓣膜32(虚线所示),瓣膜32定位在所述部件212的近端28。在示例性的实施例中,所述瓣膜32被配置为二尖瓣。应当可以理解的是,在其它的实施例中,瓣膜32可以是三尖瓣或者正方形尖瓣。所述瓣膜32可以由处理过的牛心包膜或其它合适的行之有效的生物或合成材料制成。当所述近端部件212被置入患者的主动脉16时,所述瓣膜32取代了主动脉瓣,并且允许流体(例如血液)选择性的从心脏通过,并进入到延伸通过近端部件212的通道36。
所述近端部件212的双框架214包括一自膨胀外层框架216和一固定到自膨胀外层框架216的带有瓣膜32的球囊扩张型内层框架218。参照图9,自膨胀外层框架216具有普通的沙漏形状并由金属材料如镍钛合金,不锈钢,或其它置入级的金属材料制成。应该可以理解的是在其它的实施例中所述外层框架216可由聚合物材料制成。所述外层框架216包括一延长的近端部分220,和一向内的锥形部分222,一个向外倾斜的中间部分62,和一个延长的远端部分64。
所述外层框架216延长的近端部分220包括组件212的近端28,和连接到向内锥形部分222近端226的远端224。所述近端部分220是一个管状支架。应该可以理解的是在其它的实施例中所述部分220可以成形为一个棱镜,圆锥,或者取决于患者的解剖结构的其它几何形状。
在示例性的实施例中,所述近端部分220具有约为15mm的长度228。所述近端部分220也具有约为32mm的直径230。应该可以理解的是在其它的实施例中,所述框架216的尺寸可根据患者的解剖结构而变化。在示例性的实施例中,所述直径230相对于主动脉瓣环210的直径大很多,因此当组件212被置入时,所述近端部分220和主动脉瓣环210可产生过盈配合,将在以下更详细的描述。如图9所示,所述近端部分220设有在外层框架216的通道232。
在示例性的实施例中,胶原纤维234被连接到近端部分220以助于防止瓣周漏和在主动脉壁的近端部件212的迁移。所述胶原纤维234从近端部分220向外延伸,并且向内进入通道232。应该可以理解的是在其它的实施例中,所述外层框架216可被水凝胶或者其它密封材料覆盖。在其它的实施例中,多个倒钩或钩可连接到近端部分220。所述钩可进一步吸引主动脉组织以及抑制或防止装置10的迁移。
所述外层框架216的向内锥形部分222包括近端226,以及具有连接到向外锥形中间部分62的近端68的远端236。所述部分222在端部226,236之间向内逐渐变细,从约32mm的端部226至约22mm的端部236。在示例性的实施例中,所述向内锥形部分222具有一个10mm左右的长度238。
所述自膨胀框架216的向外锥形中间部分62具有近端68和连接到所述延长的远端部分64近端74的远端72。所述部分62从一个直径约22mm的端部68到直径约28mm的端部72逐渐向外呈锥形。在示例性的实施例中,所述中间部分62具有10mm的长度76。在其它的实施例中,所述部分62的尺寸可根据,例如患者的解剖结构而变化。
所述自膨胀框架216延长的远端部分64从近端74向远端延伸到部件212的远端30。在示例性的实施例中,所述部分64具有一个大于锥形部分60,62的组合长度的长度78。在一个特定的非限制性的实施例中,所述延长的远端部分64的长度78约为30mm,其直径80约为34mm。在其它的实施例中,所述部分64的尺寸可根据例如患者的解剖结构而变化。在一个示例性的实施例中,所述远端部分64在近端74和远端30之间可逐渐变细。
如图9所示,所述自膨胀框架216的近端部分220和向内锥形的部分222可形成为一个开孔的支架结构,所述部分62,64形成为一个Z型支架结构。应当可以理解的是在其它的实施例中,所述部分62,64,220,222可形成为一个单一的整体结构,包括开孔的支架结构或者Z型支架结构。所述部分62,64,220,222的外层表面240覆盖有低剖面的聚酯,聚四氟乙烯或者其它无孔的覆盖材料242,使得流体被阻止不能流过表面240。所述覆盖的材料242在近端部分220的远侧配置有“陷门”86,其可打开以允许一个或多个用于可能的瓣周漏栓塞的外科手术器械进入。所述部分62,64,222的外表面240可被覆盖有低剖面的涤纶或其它的合成材料。应当可以理解的是所述框架216的所有或部分可覆盖有水凝胶或其它的密封材料。
如上所述,所述双框架214的外层框架216被固定到球囊扩张内层框架218,其被定位在通道232中。如图10所示,所述框架218中带有瓣膜32。所述球囊扩张内层框架218表现为一具有15mm长度246的球囊扩张型管状支架244。在其它的实施例中,所述支架244根据例如患者的解剖结构可长可短。所述支架244是管状的,并由例如镍钛合金,不锈钢,或者其它置入级金属材料制成一个开孔的结构。应当可以理解的是在其它的实施例中,所述支架244可由聚合物材料制成,并且可形成为例如一个Z型支架结构。在示例性的实施例中,所述支架244的外层表面248被覆盖有低剖面的聚酯,聚四氟乙烯或其它无孔的覆盖材料250,以防止流体通过外层表面248。然而,应当可以理解的是所述支架244可覆盖有标准的聚酯,聚四氟乙烯或其它无孔的材料。
如图10所示,所述内层框架218的支架244具有直径252。将在下面更详细的描述,所述球囊扩张内层框架218在置入过程中从未膨胀的直径(未示出)扩张到膨胀的直径252。在示例性的实施例中,当内层框架218膨胀的时候所述膨胀的直径250约为26mm。在其它的实施例中,所述膨胀的直径约等于或者大于外层框架216近端部分220的直径230。在示例性的实施例中,所述膨胀的直径252相对于主动脉瓣环210大很多因此使得当部件212被置入时近端部分220和主动脉瓣环210之间能过盈配合,并且内层框架218膨胀,这将在下面更详细的描述。
参考图11,所述双框架组件214的内层框架218通过多个针脚260被固定到外框架216上。应当可以理解的是在其它的实施例中,锡焊,焊接或其他紧固件可被用于内层框架218固定到外层框架216。如图11-14所示,所述内层框架218和瓣膜组件32被定位在自膨胀框架216设置的通道232中。当内层框架218未膨胀时,支架244的外表面248与连接到外层框架216的纤维234隔开。在示例性实施例中,一间隙264被限定在它们之间,间隙264具有约2mm至约3mm的数量级。
如图14所示,所述球囊扩张内层框架218可以在由箭头266所示的方向上扩展。如上所述,外层框架216近端部分220的直径230相对于主动脉瓣环210的直径大很多。因此,当部件212被置入时,近侧部分220降低到主动脉瓣环210的直径。所述支架244膨胀的直径252大于主动脉瓣环的直径,所述支架244的外表面248通过覆盖材料250接合纤维234(和由此的外框架216的近端部分220的内表面)。那样所述间隙264关闭,以及纤维234和覆盖材料250在内层框架218和外层框架216之间产生了密封。
植入的移植物装置10包括在患者主动脉16的近端部件212,外科医生可得到公开曝光或者经皮进入的普通股动脉。然后参考上图1-7描述的方式外科医生可以植入远侧部件14,以及推进支架24定位在动脉182。所述近端部件212可在远端部件14植入之后被展开。要做到这一点,坚硬的钢丝穿过主动脉瓣202传递到左心室204。所述近端部件212的输送系统接着穿过瓣膜202。
当输送系统到适当的位置时,所述近端部件212通过拔出系统被释放,从而允许自膨胀支架216展开。所述自膨胀支架216展开所述远端部件14的近端102使部件214,12固定在一起,并且密封了远端部件14中部件212的远端30。
当所述支架216被拔出时,所述近端部分220膨胀到与主动脉瓣环210配合,由此在支架216和主动脉瓣环210之间产生了过盈配合以及稳定装置10使其到位。如图15所示,内层框架218在外层框架216中最初未膨胀。所述内框架218可以通过扩大球囊组件来被展开。扩张的球囊扩张内层框架218使内框架218与外框架216接合,以及压缩与主动脉瓣环210相对的外框架216近侧部分220上涂覆的胶原纤维/水凝胶。如图16所示,框架216,218联合起来密封环面210以及瓣膜周围地区,因此防止了瓣周漏。因此,可以仅通过部件212的瓣膜32来允许流体从左心室204通过。如图15-16所示,所示瓣膜32被定位在靠近冠状动脉182的主动脉瓣环210上。应当可以理解的是,所述部件212的部署可以在快速心室起搏(RVP)期间进行。在主动脉瓣狭窄的情况下,在引入近端部件212之前所述瓣膜32可在球囊血管成形术中扩张。
在上述各实施例中的,近侧部件12,212的自膨胀框架部分显著提高了装置10部署的精度和控制。所述瓣膜32的双尖牙配置有三个不同的目的,包括(1)减少瓣膜接合处的数量为2个,所述剖面会减小,(2)所述瓣膜32可以更好地配合主动脉瓣环,以及(3)当环形带是不对称时,主动脉瓣关闭不全的发生率可能会降低。
现参照图17-22,所述近端部件12或者近端部件212可被用作一具有微小改动的反式导管瓣膜。这样的瓣膜可通过反式股动脉或者反式-腋窝路径来展开,这将在下面更详细的描述。
现参照图17-19,示意出了一反式导管瓣膜组件312的一个实施例。示于图17 - 19中的本实施例某些特征基本上类似于如上所述的图1-7中的近侧部件12。在图17 – 19中示意出的实施例的这些特征被指定使用与图1-7中的相同参考号。类似于图1-7中的近端部件12,所述反式导管瓣膜组件312包括了一从近端28延伸到远端30的框架26。所述框架326连接到瓣膜32(虚线所示),其定位在瓣膜组件312的近端28。当瓣膜组件312被置入患者主动脉16时,所述瓣膜32替换了主动脉瓣并且允许流体(例如:血液)选择性的从心脏流向从瓣膜组件312延伸的通道36。
所述瓣膜32被容纳在框架26的球囊扩张型框架34中。如图17所示,球囊扩张型框架34表现为一从反式导管瓣膜组件312的近端28向远侧延伸的球囊扩张支架38,且具有约为15mm的长度40。在其它的实施例中,所述支架38可根据,例如,患者的解剖结构可长可短。所述支架38为管状的,并且由金属材料例如镍钛合金,不锈钢,或者其它置入级金属材料制成一开孔的单元结构。应当可以理解的是在其它的实施例中所述支架38由聚合物材料制成,且形成例如一Z-支架结构。在示例性的实施例中,所述支架38的外表面42覆盖有低剖面聚酯,聚四氟乙烯或者其它无孔的覆盖材料44,以防止流体通过外表面42。然而,应当可以理解的是所述支架38可被覆盖有标准聚酯,聚四氟乙烯或者其它无孔的覆盖材料。
如图17所示,所述球囊扩张型框架34的支架38具有直径46。如在下面更详细地描述,所述球囊扩张型框架34在从未膨胀直径(未示意出)到膨胀的直径46的置入过程中膨胀。在示例性的实施例中,当所述框架34膨胀时,所述膨胀的直径46约为26mm。在其它的实施例中,所述膨胀的直径可大于或小于26mm,取决于例如患者的解剖结构。在示例性实施例中,所述直径46可相对于主动脉瓣环210的直径大很多,因此当反式导管瓣膜组件312被置入时,支架38和主动脉瓣环210之间可产生过盈配合。
所述球囊扩张型框架34被连接到一自膨胀框架350。在示例性实施例中,所述球囊扩张型框架34的远端52通过缝合或者缝合框架34,350在一起而被固定到框架350的近端54,由此形成反式导管瓣膜组件312的框架26。应当可以理解的是在其它的实施例中,所述框架34,350可以通过焊接或其它紧固件固定在一起。所述框架34,350可形成为一个单一的整体框架。
如图17所示,自膨胀框架350具有常规的沙漏形状,且其由金属材料制成,例如,镍钛合金,不锈钢,或者其它的置入级金属材料。应当可以理解的是在其它的实施例中所述框架350可由聚合物材料制成。所述框架350包括一个向内变细的锥型近端部分360,一个向外的锥形中间部分62,以及一延长的远端部分64。所述部分360包括一框架350的近端54和一连接到向外的锥形中间部分62的近端68的远端66。所述部分360从约26mm的端部54至约22mm的端部66之间向内逐渐变细。在示例性的实施例中,所述近端部分360具有约为15mm的长度70。
所述自膨胀框架350中向外的锥形中间部分62具有近端68和连接到延长的远端部分64近端74的远端72。所述部分62从端部68约为22mm的直径到端部72约为28mm的直径向外逐渐变细。在示例性的实施例中,所述中间部分62具有约为10mm的长度76。在其它实施例中,部分62的尺寸可根据例如,患者的解剖结构而变化。
所述自膨胀框架350延长的远端部分64从近端74到瓣膜组件312的远端312向远侧延伸。在示例性的实施例中,所述部分64包括一大于锥形部分60,62组合长度的长度78。在一个特定的非限制性的实施例中,所述延长的远端部分64的长度78约为30mm,和约为34mm的直径80。在其它的实施例中,所述部分64的尺寸可根据,例如患者的解剖结构而变化。在一个示例性的实施例中,所述远端部分64可在近端74和远端30之间逐渐变细。
如图3所示,所述自膨胀框架350的近端部分360可形成为一个开孔的支架结构,并且62,64每个部分形成为Z型支架的配置。应当可以理解的是在其它的实施例中所述部分360,62,64可形成为一个单一的结构,包括开孔的支架结构,网状支架结构,或者Z型支架的配置。所述部分60,62,64可形成为一个单一的整体部件。
如图17所示,框架350近端部分360的外表面314未被覆盖,因此流体可被允许通过开口318。所述部分62,64的外表面316覆盖有低剖面的聚酯,聚四氟乙烯,或其它无孔的覆盖材料84,因此使得流体被阻止不能通过表面320。所述瓣膜组件312的外表面320也可被低剖面的涤纶或其它合成材料覆盖。所述未覆盖的,开孔的支架部分360被配置为允许冠状动脉灌注。所述覆盖的部分62,64用于相对主动脉18来稳定瓣膜组件312,以及提供一个对接站,用于升主动脉延伸或开窗/支拱移植。所述覆盖部分62,64也允许未经窦管交界处扩张的B型动脉瘤适用的瓣膜组件312的移植物延伸。
反式导管瓣膜组件312的传输可以从获得自然主动脉瓣进入左心室开始。一个升主动脉造影可经执行以定位左,右冠状动脉。一个以上的钢丝导引系统,包括用于引入该瓣膜组件312进入主动脉18的导丝。导丝经由股动脉,锁骨下动脉或颈动脉血管被放置到左心室204后,所述瓣膜组件312可以通过普通的股动脉被传递并通过自然主动脉瓣202。进行血管造影显示冠状动脉182的位置后,所述瓣膜组件312通过拔出输送系统被释放,因此允许自膨胀框架350的膨胀,如图18-19所示。
所述球囊扩张型框架34可通过在传输系统内膨胀球囊来展开球囊扩张型框架34。由此展开框架34到预定的膨胀直径46以及促进框架34与主动脉瓣环210配合,由此密封了主动脉瓣环210使得流体被允许仅流过瓣膜32来通过左心室204,并且瓣膜32被定位在靠近冠状动脉182的主动脉瓣环210,如图18-19所示。所述瓣膜组件312的未覆盖部分360的开口318允许血液流入冠状动脉182促进循环。应该可以理解的是所述瓣膜组件312的部署可在快速心室起搏(RVP)期间进行。
现参照图20-22,示意出了一反式导管瓣膜组件(以下为瓣膜组件412)的另一个实施例。图20-22中示意出的实施例的一些特征实质上与如上所述的图8-16中参考的近端部件212相似。在图20-22中这样的特征被指定使用与图8-16中相同的参考号。类似于图8-16中的近端部件212,所述瓣膜组件412包括一从近端28向远端30延伸的双框架414。所述框架414连接到瓣膜32(虚线所示),其被定位在部件412的近端28。在示例性的实施例中,所述瓣膜32被设计为二尖瓣。当瓣膜组件412被置入患者的主动脉16时,所述瓣膜32代替了主动脉瓣并且允许流体(例如血液)选择性的通过心脏,并进入延伸通过瓣膜组件412的通道36。
所述双框架414包括一自膨胀外层框架416和一固定到自膨胀外层框架416并容纳有瓣膜32的球囊扩张型内层框架218。参照图9,所述自膨胀外部框架416具有常规的沙漏形状,并由金属材料例如镍钛合金,不锈钢或其它不锈钢置入级金属材料制成。应当可以理解的是在其它的实施例中,所述外层框架416可由聚合物材料制成。所述外部框架416包括一延长的近端部分220,一向内锥形部分422,一向外锥形中间部分62,以及一延长的远端部分64。
所述外层框架416的延长的近端部分220包括所述部件412的近端28和连接到向内锥形部分222近端226的远端224。所述近端部分220表现为一管状支架。应该可以理解的是在其它的实施例中,所述部分220可根据患者的解剖结构被做成棱镜,锥,或其它几何形状。
在示例性的实施例中,所述近端部分220具有约为15mm的长度228。所述近端部分220也具有约为32mm的直径230。应当可以理解的是在其它的实施例中,所述框架416的尺寸可根据患者的解剖结构而变化。在示例性的实施例中,所述直径230相对于主动脉瓣环210的直径大很多,因此当瓣膜组件412被置入时,所述近端部分220和主动脉瓣环210产生了过盈配合。将在下文更详细的描述。如图9所示,所述近端部分220设置了外层框架416中的通道232。
在示例性的实施例中,胶原纤维234被连接到近端部分220以有助于防止瓣周漏和主动脉壁内的瓣膜组件412迁移。所述纤维234从近端部分220向外延伸并且向内进入通道232。应当可以理解的是在其它的实施例中外层框架216可覆盖有水凝胶或其它的密封材料。在其它的实施例中,多个倒钩或钩可连接到所述近端部分220。所述钩可以被配置为进一步接合主动脉的组织,并且抑制或防止所述装置10的迁移。
所述外层框架416的向内锥形部分422包括近端226和连接到向外锥形中间部分62近端68的远端236。所述部分422在约为32mm的端部226到约为22mm的端部236之间向内逐渐变细。在示例性的实施例中,所述向内锥型部分422具有约为10mm的长度238。
所述自膨胀框架416向外的锥形中间部分62具有近端68和连接到延长的远端部分64近端74的远端72。所述部分62在约为22mm直径的端部68到约为28mm直径的端部72之间向外逐渐变细。在示例性的实施例中,所述中间部分62具有约为10mm的长度76。在其它的实施例中,所述部分62的尺寸可根据,例如患者的解剖结构而变化。
所述自膨胀框架416的延长的远端部分64从近端74到组件412的远端30之间向远侧延伸。在示例性实施例中,所述部分64具有大于锥形部分60,62组合长度的长度78。在一个特定的非限制性的实施例中,所述延长的远端部分64的长度78约为30mm,且具有约为34mm的直径80。在其它的实施例中,所述部分64的尺寸可根据,例如患者的解剖结构而变化。在一个示例性的实施例中,所述远端部分64可在近端74和远端30之间逐渐变细。
如图20所示,自膨胀框架416的每个近端部分220和向内的锥形部分422形成为一个开孔支架结构,并且每个部分62,64形成为Z型支架的结构。应当可以理解的是在其它的实施例中所述部分62,64,220,422可形成为单一的结构,包括开孔支架结构,网状支架结构,或者Z-支架结构。所述部分62,64,220,422可形成为一个单一的整体部件。所述部分62,64的外表面440覆盖有低剖面的聚酯,聚四氟乙烯,或者其它无孔的覆盖材料442使得流体被阻止不能通过表面440。所述部分422的外表面444未被覆盖以便允许流体通过设置在表面444中的开口446。所述未覆盖的,开孔的部分422被配置为允许冠状动脉灌注。所述覆盖的部分62,64相对主动脉18稳定瓣膜组件412,并提供一个对接站,用于升主动脉延伸或开窗/支拱移植。
如上所描述的,所述被定位在通道232中,且容纳有瓣膜32的双框架414的外层框架416被固定到球囊扩张型内层框架218。如上所述,球囊扩张框架218在未膨胀的直径450到膨胀的直径(未示意出)的置入过程中膨胀。
为了部署所述瓣膜组件412,将硬钢丝穿过主动脉瓣202传递到左心室204。所述瓣膜组件412的输送系统接下来穿过瓣膜202。当输送系统定位时,瓣膜组件412被释放出外壳系统,由此允许自膨胀框架416的膨胀。所述框架416的近端部分220膨胀到与主动脉瓣环210配合,因而在框架416和主动脉瓣环210可产生过盈配合,且稳定瓣膜组件412到位。如图21所示,内框架218最初在外框架416中未膨胀。所述内框架218通过膨胀所述球囊组件来被展开。球囊扩张内层框架218与外层框架416的内层框架218配合,并压缩与主动脉瓣环210相对的外框架416的近端部分220覆盖的胶原纤维/水凝胶。
如图22所示,所述框架218,416配合起来密封环面210和瓣周区域,并且因此防止了瓣周漏。因此,流体可以只通过部件412的的瓣膜32来从左心室204通过。所述瓣膜组件412的未覆盖部分422的开口446允许血液流过冠状动脉182促进循环。
应当可以理解的是部件12,14,212的设计以及反式导管瓣膜312,412有意考虑到潜在故障模式,并允许改正任何相关的失效模式。例如,关于部件12,14,212,瓣周漏可被修正。更具体地,相对于一个瓣周漏(1a型内漏),围绕瓣膜32的泄漏将当做1a型内漏。在部件12,312的陷阱门86将允许泄漏区域的螺圈栓塞。在180度位置的两个陷门会允许接近主动脉瓣环上方的整个区域。由于冠状动脉182受远端部件14的导管22的保护,这一区域的螺圈栓塞不会损害的冠状动脉血流量。如果瓣膜周围有额外泄漏的话,瓣周漏的螺圈栓塞已经在心脏瓣膜手术后在临床上被实施。
主动脉瓣关闭不全(Al)在植入后也可校正。在反式导管瓣膜置入后显著的(Al)已被记录在患者中高达17%。除了严重的环形钙化,当前瓣膜的三尖瓣的形态和主动脉环的卵形可导致引起Al的瓣膜叶 不充分的接合。在此讨论的设计的二尖瓣类型潜在的消除了
不充分接合和次要的Al问题。
结构上的瓣膜退化也可以被修正。更具体的说,二尖瓣设计允许另一个反式导管瓣膜的放置来穿过第一装置而不损害瓣膜流区。
冠状动脉功能不全可被修正。与部件14的锥形部分128一起使用的卡布罗尔内切导管22确保了不间断的冠状动脉血流量。通过首先部署部件14,外科医生将能够工作,通过卡布罗尔导管22,并使用标准的导管和导丝将导管插入到右和左冠状动脉。支架24从冠状动脉展开到卡布罗尔导管22。部署所述部件12或部件212可能会被延迟,直到冠状动脉的血流量能保证。锥形设计可减低装置10与主动脉壁之间的冠状动脉支架被压缩的风险。
对于反式导管瓣膜312,412,瓣周漏也可以在瓣膜开孔的中间部360,422被修正
,如果必要的话在冠状动脉的保护后允许带有潜在螺圈栓塞漏洞的冠状动脉的插管和支架置入术。
在反式导管瓣膜312,412中的结构性瓣膜退化可以被修正,所述二尖瓣设计允许另一个反式导管瓣膜的放置穿过第一装置而不损害瓣膜流区。
双框架组件也可以采取其他反式导管瓣膜置换装置的形式,例如,人工二尖瓣和三尖瓣。双框架组件也可用于增强血管内装置的密封区域来治疗腹部和胸部的动脉瘤,并在应用中以治疗外周血管疾病。
应当可以理解的是在此描述的所述装置和方法具有广阔的应用前景。被选择和描述的上述实施例是为了说明的方法和装置原理以及一些实际应用。前面的描述使本领域技术人员去利用具有多种实施例和多种修改的方法和装置,以适合于所预期的特定用途。根据专利法的规定,本发明的原则和操作模式已进行了说明,并在示例性实施例示出。
虽然意图是本发明方法和装置的范围由所附权利要求来限定。然而,但必须理解,本发明可以用不同于具体说明和图示的方式实施而不背离其精神或范围。应该可以理解的是它应当由本领域技术人员替代这里所描述的实施例并可以在本领域中如在下面权利要求中定义的不脱离其精神和范围内实施权利要求。
本发明的保护范围应该被确定,不是参考上面的描述,而应该参照所附的权利要求,以及其等同于这些权利要求所享有的全部范围来确定。据预测,并预期,未来的发展将发生在此讨论的领域,并且所公开的系统和方法将被纳入未来这样的例子。此外,在权利要求书中使用的所有术语旨在被给予本领域技术人员理解的最宽泛的合理结构和它们的普通含义,除非明确指示本文中是相反的。尤其是,使用的单数冠词如“一”,“该”,“所述”等应被理解为叙述所指示的一个或多个元素,除非权利要求明确的限制与此相反。本文意图是下面的权利要求限定本发明的范围,并且涵盖在这些权利要求范围内的方法和设备及其等同物。总之,应当理解,本发明能够修改和变化,并且仅由所附权利要求限定。
Claims (27)
1.一种用于升主动脉瘤腔内修复术的移植物装置,包括:
第一假体部件包括(i)一近端框架,和(ⅱ)一固定到近端框架并延伸到第一假体部件远端的远端框架,
至少一个固定在第一假体部件和定位于邻近近端框架的导管,
固定到第一假体部件近端的第二假体部件,所述第二假体部件包括(i)从第二假体部件的近端向远端延伸的球囊扩张支架,以及(ii)连接到所述球囊扩张支架和延伸到第二假体部件的远端处的自膨胀支架,和
一个固定到所述第二假体部件近端的球囊扩张支架的瓣膜元件。
2.根据权利要求1所述的移植物装置,其特征在于:所述自膨胀支架具有沙漏形状。
3.根据权利要求2所述的移植物装置,其特征在于:所述自膨胀支架包括:
在近端和远端之间向内渐缩的第一部件,和
具有一近端连接到第一部件远端的第二部件,在第二部件的近端和第二部件的远端之间向外逐渐变细。
4.根据权利要求3所述的移植物装置,其特征在于:所述第一部件的近端被固定到所述球囊扩张支架的远端。
5.根据权利要求3所述的移植物装置,其特征在于:
所述自膨胀支架包括从第一部件的近端向近侧延伸的第三部件,第三部件具有一个设置在其中的通道,以及
球囊扩张支架定位在所述自膨胀支架的第三部件中的通道。
6.根据权利要求5所述的移植物装置,其特征在于:所述球囊扩张支架在(ⅰ)球囊扩张支架的外表面与自膨胀支架内表面隔开的未展开的位置,和((ii)球囊扩张支架的外表面与自膨胀支架内表面接合的展开的位置之间是可扩展的。
7.根据权利要求6所述的移植物装置,其特征在于:多个纤维附着在自膨胀支架的第三部件,当所述球囊扩张支架处于展开位置时,球囊扩张支架的外表面与多根纤维接合。
8.根据权利要求1所述的移植物装置,其特征在于:第一假体部件的近端框架中设置有通道,第二假体部件的远端定位在第一假体部件的通道中。
9.根据权利要求1所述的移植物装置,其特征在于:至少一导管包括一对定位在第一假体部件相对侧的导管。
10.根据权利要求1所述的移植物装置,其特征在于:具有一个近端开口位于靠近第一假体部件近端的至少一导管。
11.根据权利要求10所述的移植物装置,其特征在于:所述近端框架包括(i)固定到第二假体部件远端的第一部件,和(ii)连接到第一部件的第二部件,第二部件在连接到第一部件的近端和远端之间向外逐渐变细,以及具有近端框架的第二部件中设置的远端开口的至少一导管。
12.根据权利要求11所述的移植物装置,其特征在于:进一步包括了具有一个远端定位在至少一导管的近端开口中,以及近端被设置在冠状动脉中的支架。
13. 根据权利要求1所述的移植物装置,其特征在于:
第二假体部件的外表面和第一假体部件的近端框架的外表面被覆盖,由此流体被阻止通过,以及
第一假体部件的远端框架的外表面未被覆盖,由此流体被允许通过。
14.一反式导管瓣膜,包括:
一框架组件包括:
从框架组件的近端向远端延伸的球囊扩张支架,和
一固定到球囊扩张支架的自膨胀支架,自膨胀支架包括(i)在近端到远端之间向内逐渐变细的第一部件,和(ii)在远端和固定到第一部件远端的近端之间向外逐渐变细的第二部件,以及
定位在框架组件近端的球囊扩张支架的瓣膜元件。
15.根据权利要求14所述的反式导管瓣膜,其特征在于:
所述框架组件为双框架组件,
所述自膨胀支架为双框架组件的外层框架,并且其中设置有通道,
所述球囊扩张支架是双框架组件的一个内层框架并定位在自膨胀支架所设置的通道,并且
所述球囊扩张支架在(ⅰ)球囊扩张支架的外表面与自膨胀支架内表面隔开的未展开的位置,和((ii) 球囊扩张支架的外表面与自膨胀支架内表面接合的展开的位置之间是可扩展的。
16.根据权利要求15所述的反式导管瓣膜,其特征在于:多个纤维附着在自膨胀支架,当所述球囊扩张支架处于膨胀展开位置时,球囊扩张支架的外表面与多根纤维接合。
17.根据权利要求14所述的反式导管瓣膜,其特征在于:所述自膨胀支架的第一部件外表面未被覆盖,由此流体被允许通过,以及所述自膨胀支架的第二部件的外表面被覆盖,由此流体被阻止通过。
18.根据权利要求14所述的反式导管瓣膜,其特征在于:所述自膨胀支架包括一从第二部件向远侧延伸的延长的部分,所述延长的部分具有大于所述第一部件和第二部件的组合长度的长度。
19.根据权利要求14所述的反式导管瓣膜,其特征在于:所述自膨胀支架覆盖有胶原纤维或水凝胶中的至少一种。
20.根据权利要求14所述的反式导管瓣膜,其特征在于:所述瓣膜元件为二尖瓣和三尖瓣之中的一种。
21.一种修复患者主动脉的方法,包括:
将第一假体部件引入病人的主动脉使得第一假体部件的近端框架被定位在升主动脉,以及第一假体部件的远端框架被定位在患者主动脉的主动脉弓,
推进覆膜支架穿过设置在第一假体部件中的导管进入患者主动脉的冠状动脉内,
确保第二假体部件到患者主动脉中第一假体部件的近端,和
展开第二假体部件的近端部分与患者主动脉的主动脉瓣环配合,由此固定到近端部件的瓣膜组件被定位在靠近冠状动脉的主动脉瓣环上。
22.根据权利要求21所述的方法,其特征在于:膨胀的第二假体部件的近端部分包括操作一球囊扩张支架。
23.根据权利要求22所述的方法,其特征在于:膨胀的第二假体部件的近端部分包括:
允许自膨胀支架扩展到与主动脉瓣环接合,和
操作所述球囊扩张支架包括在自膨胀支架与主动脉瓣环接合之后,促进所述球囊扩张支架的外表面与自膨胀支架的内表面接合。
24.根据权利要求22所述的方法,其特征在于:操作所述球囊扩张支架包括促进球囊扩张支架的外表面与主动脉瓣环接合。
25.根据权利要求21所述的方法,其特征在于:
第二假体部件的外表面和第一假体部件的近端框架的外表面被覆盖,由此使得流体被阻止不能通过,以及
第一假体部件的远端框架的外表面未被覆盖使得流体被允许通过。
26. 根据权利要求21所述的方法,其特征在于:
引入第一假体部件进入到患者的主动脉,并在第一外科手术过程中实施促进覆膜支架穿过设置在第一假体部件中的导管进入到患者主动脉的冠状动脉,以及
确保第二假体部件到第一假体部件的近端,并在不同于第一外科手术过程的第二外科手术过程中实施扩展第二假体部件的近端部分到与患者主动脉的主动脉瓣环配合。
27.根据权利要求21所述的方法,其特征在于:进一步包括了在引入第一假体部件之前,引入第二假体部件到升主动脉。
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