CN102292053A - 心脏瓣膜 - Google Patents

心脏瓣膜 Download PDF

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CN102292053A
CN102292053A CN2009801476224A CN200980147622A CN102292053A CN 102292053 A CN102292053 A CN 102292053A CN 2009801476224 A CN2009801476224 A CN 2009801476224A CN 200980147622 A CN200980147622 A CN 200980147622A CN 102292053 A CN102292053 A CN 102292053A
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布伦特·J·拉茨
阿沙德·夸德里
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卡迪尔克阀门技术公司
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Priority to PCT/US2009/058893 priority patent/WO2010037141A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
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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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
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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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    • A61F2/2403Heart 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 with pivoting rigid closure members
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    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
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    • AHUMAN NECESSITIES
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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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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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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    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

一种心脏瓣膜(600),包括由柔性材料例如心包膜制成的瓣膜体(330)。所述瓣膜体由两层材料,外层和限定多个小叶的内层制成。内层的小叶附着于外层。在一些实施方式中,通过切割单片的平面源组织、折叠切割的组织并使其形成为具有内层和外层的管状图案来制造所述瓣膜体。可将多层瓣膜体安装在支架(500)上用于在患者心脏内的递送。

Description

心脏瓣膜

[0001] 相关申请的参考

[0002] 本申请要求于2008年9月四日提交的美国临时申请系列第61/136,716号的优先权。至少所述优先权申请中描述由平展(平坦)的源材料形成的基于组织的瓣膜体、所述瓣膜体的生产以及放置在支架上和与支架结合使用的实施方式的部分,如优先权申请的第[00020]-[00027]段和图1至图8D中所论述的,通过引用结合于本文中。

技术领域

[0003] 本发明涉及置换心脏瓣膜。更具体地,本发明涉及基于组织或基于模拟组织的置换心脏瓣膜。

背景技术

[0004] 包括主动脉瓣、肺瓣、二尖瓣和三尖瓣的人类心脏瓣膜主要起与泵血心脏的同步化中运行的单向阀的作用。所述瓣膜使得血液流入下游方向,但是阻止血液流入上游方向。 患病的心脏瓣膜呈现出诸如瓣膜狭窄或反流(回流)的损伤。这样的损伤降低心脏的泵血效率并且可以是使人虚弱且威胁生命的病症。例如,瓣膜闭锁不全(瓣膜机能不全)可以导致诸如心脏肥大和心室扩张的病症。因此,已经进行了巨大的努力以开发修复或置换受损的心脏瓣膜的方法和装置。

[0005] 存在假体以矫正与受损的心脏瓣膜相关的问题。例如,机械的和基于组织的心脏瓣膜假体可以用于置换受损的天然心脏瓣膜。最近,已经付出了大量努力以开发置换心脏瓣膜,特别是基于组织的置换心脏瓣膜,其可以以与通过开心脏术相比对患者更小的创伤被递送。将置换瓣膜设计成通过最小的侵入性程序(手术)并且甚至是经皮程序(手术) 递送。这样的置换瓣膜经常包括连接至可扩张的支架(expandable stent)的基于组织的瓣膜体,所述支架于是被递送至天然瓣膜环。

[0006] 可以压缩以用于递送然后可控扩张以用于受控的布置的置换心脏瓣膜的开发已被证明是特别有挑战性的。另外,特别是基于组织的置换瓣膜的耐用性问题首当其冲。例如,基于组织的瓣膜通常包括缝合在一起的组件,并且这样的接缝(缝合)可以是应力集中的来源,特别是当使用相对薄的组织时。

发明内容

[0007] 因此,本领域需要一种具有增强的耐用性并且本身适于在最小侵入和/或经皮递送中压缩和可控扩张的基于组织的心脏瓣膜。

[0008] 根据一个实施方式,本发明提供了一种包括具有外层和内层的瓣膜体的置换心脏瓣膜。所述外层是管状的并且具有纵轴线(纵轴)、上游末端(上游端)和下游末端(下游端),并且是由薄的柔性材料形成。所述内层通常是管状的,具有通常与外层共线的纵轴线 (纵轴),并且位于管状外层内。所述内层由薄的柔性材料形成并且限定多个适于在打开状态与接合状态(收缩状态)之间移动的小叶。每一小叶具有侧边和下游部分。内层的相邻小叶通过连合部分(联接部分,缝口部分)连接。所述小叶沿着小叶侧边(小叶侧边缘) 连接至外层,并且所述连合部分附着至小叶侧边的至少一部分下游的外层。

[0009] 在一种这样的实施方式中,所述内层和外层由柔性材料的单一连续切片(部分) 构成。在另一种实施方式中,所述内层和外层在上游末端相对于彼此折叠使得内层在上游末端与外层邻接。

[0010] 在另一实施方式中,所述外层包括连合缝(联接缝,commissural slit),并且内层的连合部分之一的边缘至少部分地延伸通过该缝。在一种这样的实施方式中,所述外层包括被成形为补充相应的小叶侧边的小叶缝,并且所述小叶侧边至少部分地延伸通过该缝。

[0011] 在又一实施方式中,所述外层具有多个通过其中形成的窗口,并且所述窗口被构造成使得当小叶处于接合状态时血液可以容易地通过这些窗口流动。

[0012] 在另外的实施方式中,置换心脏瓣膜包括瓣膜体和可以径向收缩成收缩状态并且径向扩张成扩张状态的细长支架。所述支架具有纵轴线,并且所述瓣膜体附着(连接)于该支架。

[0013] 在一种这样的实施方式中,所述瓣膜体的外层在所述支架的外侧上并且所述瓣膜体的内层在所述支架的内侧上,使得所述支架被夹在所述内层与外层之间。

[0014] 在另一种这样的实施方式中,定位所述瓣膜体,使得所述支架与该瓣膜体的外表面相邻。在一些这样的实施方式中,所述瓣膜体的外层连接至所述支架,并且所述瓣膜体的内层直接连接至外层,但是不直接连接至支架。在另外的这样的实施方式中,当所述小叶处于打开位置(open position)时,瓣膜体的外层置于打开的小叶与支架之间。

[0015] 在又一这样的实施方式中,所述支架具有前缩部分(透视缩短部分,投影缩短部分,缩短部分,foreshortening portion),该前缩部分被构造成使得当所述支架径向收缩时,该前缩部分纵向扩张,并且当该支架径向扩张时,该前缩部分纵向收缩。

[0016] 在一种具有这样的前缩支架的实施方式中,将至少一部分瓣膜体至少部分地设置在前缩部分内,并且所述瓣膜体与该支架在一个或多个连接点处连接,所述连接点通常沿着支架纵轴线与轴点对齐,使得在前缩期间,所述支架相对于瓣膜体纵向移动而没有纵向拉伸或挤压(压碎)瓣膜体。一种这样的实施方式另外包括与所述支架和瓣膜体直接连接的可纵向扩张的材料。所述柔性材料在一个或多个与轴点纵向间隔开的连接点处与支架直接连接。

[0017] 在另一具有前缩支架的实施方式中,所述支架还包括非前缩部分,并且瓣膜体保持在该非前缩部分内。

[0018] 根据另一实施方式,本发明提供了一种制造置换心脏瓣膜的方法。所述方法包括提供平展(平坦,扁平)的柔性源材料并且根据期望的图案(模式,pattern)剪切该平展材料。所述图案限定第一和第二图案末端、裙端部分(裙缘部分,skirt portion)和小叶部分。所述小叶部分限定多个小叶、在相邻小叶之间延伸的连合部(连合,接着面, commissures),并且各小叶具有侧边。该方法还包括使第一和第二图案末端毗连,以便使所述平展材料形成为管,沿着折线相对于裙端部分折叠小叶部分使得该小叶部分通常在裙端部分内,使连合部(commissures)与裙端部分结合,并且使小叶侧边与裙端部分结合。

[0019] 另一实施方式还包括提供一种具有与闭合状态的瓣膜的期望形状基本相反的形状的模板(form),所述模板具有小叶成形部分,并且在所述平展材料被形成为管并且使连

5合部附着于裙端部分之后,将瓣膜置于该模板上使得小叶与小叶成形部分接合(衔接),并且当小叶与小叶成形部分接合时使小叶侧边附着(连接)于裙端部分。

[0020] 另一这样的实施方式还包括在裙端部分中形成小叶缝(leaflet slits),所述小叶缝基本上对应于该小叶的期望曲率,并且将所述瓣膜置于模板上使得小叶与小叶成形部分接合,其包括使小叶侧边延伸通过裙端部分中的小叶缝。

[0021] 另一实施方式还包括提供一种细长支架,并且使裙端部分附着于所述支架。

[0022] 在另一实施方式中,瓣膜体被连接至支架,使得小叶基本上在左心房内。在其他实施方式中,瓣膜体被连接至支架,使得小叶的下游末端通常设置在二尖瓣环内。

[0023] 根据又一实施方式,本发明提供了一种限定连接至可纵向伸展部分的多个小叶的柔性管状瓣膜体。与该纵向伸展部分相比,所述瓣膜体是更少纵向伸展的。在一种这样的实施方式中,将该瓣膜体和连接的可纵向伸展部分安装在具有前缩部分的支架上, 并且瓣膜体的一部分与该前缩部分重叠,使得当支架前缩(缩短,透视缩短,投影缩短, foreshortens)时,可纵向伸展的部分优先伸展或收缩,使得所述瓣膜体相对于支架纵向移动。

[0024] 在另一实施方式中,通过分别形成内层和外层,使内层的上游末端结合至外层,并且使小叶的侧边和连合片(commissural tabs)结合至外层来构造具有内层和外层的瓣膜体,所述内层限定多个小叶。在一种这样的实施方式中,通过外层形成缝,并且将一个或多个连合片和小叶至少部分地通过相应的缝抽出,然后固定至外层。

[0025] 下面公开了本发明的其它实施方式和特征。

附图说明

[0026] 图1示出了用于切割平展源材料以产生心脏瓣膜体的实施方式的平展图案(平坦图案,平坦模式)。

[0027] 图2A是按照图1的平展图案切割并且形成为管的组织的侧视图。

[0028] 图2B是图2A的组件(装配)的透视图。

[0029] 图3A是形成为心脏瓣膜体并以打开状态(打开位置)示出的图1的组件的透视图。

[0030] 图;3B示出了处于闭合状态并且从下游位置观察的图3A的心脏瓣膜体。

[0031] 图3C示出了处于闭合状态并且从上游位置观察的图3A的心脏瓣膜体。

[0032] 图4A是以收缩状态示出的支架框架(支架框)的实施方式的示意图。

[0033] 图4B示出了处于扩张状态(展开状态)的图4A的支架框架。

[0034] 图5是其上安装有图1-3的瓣膜体的图4A和图4B的支架框架的侧视图。

[0035] 图6A是包括安装在支架框架上的组织瓣膜体的心脏瓣膜的另一实施方式的侧面透视图。

[0036] 图6B示出了处于闭合状态并且从下游位置观察的图6A的心脏瓣膜。

[0037] 图6C示出了处于闭合状态并且从上游位置观察的图6A的心脏瓣膜。

[0038] 图7示出了用于切割平展源组织以形成瓣膜体的另一实施方式的平展图案。

[0039] 图8示出了由根据图7的图案切割的组织构造的瓣膜体的透视图。

[0040] 图9A是图8的瓣膜体一侧的特写图(局部放大图)。[0041] 图9B是如图9A的特写图但是示出了另一实施方式的特征。

[0042] 图10示出了用于切割平展源组织以形成心脏瓣膜体的又一实施方式的平展图案。

[0043] 图11是用于支撑心脏瓣膜体的支架框架的另一实施方式的示意性侧视图。

[0044] 图12是其上安装了由根据图10的图案切割的源组织构造的心脏瓣膜体的图11 的支架框架的透视图。

[0045] 图13示出了处于闭合状态并且从下游位置观察的图12的心脏瓣膜。

[0046] 图14示出了根据一种实施方式的置于人心脏的二尖瓣环内的图12的心脏瓣膜。

[0047] 图15是示出了与图11类似的心脏瓣膜支架框架的相对壁并且示意性地示出了根据另一实施方式的可扩张的纤维(织物)部分在支架上的放置的示意性侧剖视图。

[0048] 图16A是心脏瓣膜的另一实施方式的侧视图,示出了安装在根据另一实施方式的支架上的图8的瓣膜体。

[0049] 图16B是以收缩状态示出的图16A的组件的侧视图。

[0050] 图17示出了根据另一实施方式的置于人心脏的二尖瓣环内的图16的心脏瓣膜。

[0051] 图18示出了用于切割平展源组织以形成瓣膜体的又一实施方式的平展图案。

[0052] 图19描绘了由图18的图案构造的心脏瓣膜体的透视图。

[0053] 图20是用于构造组织瓣膜体的工具的实施方式的透视图。

[0054] 图21示出了正被用于构造如图18-19的组织瓣膜体的图20的工具。

[0055] 图22示出了用于切割平展源组织以形成瓣膜体的另一实施方式的平展图案。

[0056] 图23是安装在支架上的具有由图22的图案构造的瓣膜体的心脏瓣膜的实施方式的透视图。

[0057] 图M是用于根据图23的组件的支架的局部侧视图。

[0058] 图25是图M的心脏瓣膜的垂直剖面的示意性局部侧视图。

具体实施方式

[0059] 本发明的说明书和附图公开了在被构造成用于置换患者的天然心脏瓣膜的置换心脏瓣膜及其部分的许多实施方式的背景下的本发明的方面和特征。可以将这些实施方式连同替换具体瓣膜,诸如患者的主动脉瓣膜或二尖瓣一起论述。然而,应当理解,特定瓣膜或瓣膜的特定特征的上下文不应视为是限制性的,并且如果需要以及在适当时,本文所论述的任何一种实施方式的特征可以与其它实施方式的特征组合。

[0060] 首先参考图1-3,描述了用于心脏瓣膜体30的结构以及制造瓣膜体30的方法。在该实施方式中,该心脏瓣膜体是由基于组织的介质例如牛心包膜(心包)构造的。当然,可以采用其它材料例如马心包膜和猪心包膜,血管组织,以及其它薄的、柔性的并且耐久的天然和人造材料。优选地,以平展源材料提供所述组织。

[0061] 图1示出了用于切割平展源组织以形成心脏瓣膜体30的实施方式的平展图案32。 更具体地,优选以平展形式(flat format)展开(布置)源组织,然后根据所示出的平展图案32切割。优选地,通过激光来切割所述组织,但是可以采用其它切割方式和方法。

[0062] 如图1所示,根据所述图案切割的平展源组织具有第一和第二图案末端34、36。裙端部分40和小叶部分50被折线52间隔开。所示出的小叶部分50包括在连合片部分60相互连接的三个小叶M。每一小叶M具有优选为弯曲的下游边缘62,并且还具有弯曲的、 通常相对的第一和第二小叶侧边64、66。根据示出的实施方式中的图案32,相邻的小叶M 由在它们之间切割的空隙68限定。

[0063] 示出的裙端部分40包括由切入平展源组织的孔(孔隙)限定的三个窗口 70。窗口 70各自具有第一和第二侧边72、74,所述第一和第二窗口侧边72、74通常分别与相应的小叶讨的第一和第二侧边64、66的曲率互补。裙端部分40的下游环76优选从第一图案末端34连续延伸至第二图案末端36。类似地,平展图案32的上游环部分78在折线52处从第一图案末端34连续延伸至第二图案末端36并且与折线52相邻。小叶支撑物(小叶支架)80被限定在相邻的窗口 70之间,并且共用第一和第二窗口侧边72、74。小叶支撑物 80从上游环78延伸至下游环76。在示出的实施方式中,第一和第二图案末端34、36被布置成平均分割裙端部分40的小叶支撑物80之一和小叶部分50的连合片部分60之一。

[0064] 参考图2A和图2B,一旦从平展源组织切割下图案32,将所切割的组织卷起并且使第一和第二图案末端34、36连在一起以形成如所示出的管状结构。在所示出的实施方式中,通过优选采用常规缝合材料的接缝(缝合线,seam)将所述第一和第二图案末端34、36 连在一起。因此,裙端部分40中的接缝82与第一和第二图案末端34、36连接,以便完善 (完成)小叶支撑物80,并且小叶部分50中的接缝84完善连合片6。

[0065] 尽管在示出的实施方式中使用了缝合,但是应当理解,当形成瓣膜体时可以使用其它方法和装置以接合第一和第二末端并产生其它连接。例如,在其它实施方式中,可以采用粘合剂、夹子等。

[0066] 在另外参考图3A-C的情况下,一旦使第一和第二图案末端34、36接合以便形成管状结构,可在折线52附近将小叶部分50折叠并倒置在裙端部分40的内部。因此,瓣膜体 30的小叶部分50位于裙端部分40内并且通常与其毗邻。

[0067] 在继续参考图3A-C的情况下,一旦折叠,使得小叶部分50位于裙端部分40内,则小叶部分50和裙端部分40便彼此连接。更具体地,第一和第二小叶边缘64、66与相应的小叶支撑物80的各自的第一和第二窗口侧边72、74连接。如所示出的,边缘64、66、72、74 通常优选对齐,使得有助于通过接缝(seam)连接。优选地,通过使用常规材料例如缝合材料以常规方式缝合来完成这样的连接(结合,attachments) 0然而,还可以使用其它材料, 例如粘合剂。另外,在一些实施方式中,代替缝合或除了缝合外,可以通过夹子将连合片固定至裙端(skirt)。此外,在又一实施方式中,可以单独形成小叶部分和裙端部分,然后在例如上游环处将它们连接。这样的备选方案将应用于本文论述的其它实施方式和特征。

[0068] 一旦小叶部分50被适当地连接至裙端部分40,瓣膜体30可以在图3A所示的开放状态与图3B和图3C所示的闭合状态之间移动。如图;3B和图3C所示,当闭合时,瓣膜小叶M彼此接合从而阻止血液流向小叶M之间的上游。而且,由于在支撑物80处将小叶M 牢固地缝合在裙端40上,瓣膜体30的上游末端78处的裙端部分40与小叶部分50之间没有血液流动,因此阻止了环瓣膜周围渗漏(paravalvular leaks) 0在示出的实施方式中, 裙端部分40的窗口 70通常与小叶M对齐。因此,当小叶M处于闭合状态时,血流被小叶讨转向并容易地流过窗口 70。

[0069] 图3A-C的瓣膜体30适用于替换患者的天然瓣膜,并且采用结合示出的瓣膜体30 描述的特征的实施方式可以单独使用或与支架框架结合使用。例如,在一种实施方式中,可以将如图3A的瓣膜体30安装到患者的天然动脉瓣膜的环内。在这样的实施方式中,将上游环78缝合至或以其他方式连接至天然瓣膜环,并且将下游环76连接至环下游的主动脉。 因此,瓣膜体30位于主动脉窦内。在该实施方式中,裙端部分40的窗口 70是特别有用的, 因为当小叶讨接合时,血液容易地流过窗口 70并进入从主动脉窦分支的心脏动脉。

[0070] 接着参考图4和图5,可以将如图3的心脏瓣膜体30安装在支架90上。这样的支架可以具有各种设计和特征。例如,这样的支架可以是自扩张的、气囊扩张的、混合的等。

[0071] 特别是参考图4A和图4B,示出的支架框架90实施方式支撑瓣膜体30并且可以从如图4A所示的收缩状态扩张至如图4B所示的扩张状态。示出的支架90优选是由柔性材料,优选形状记忆材料如镍钛诺构造的自扩张支架。由于其是自扩张的,所以当松弛时支架 90处于如图4B所示的完全打开状态。示出的支架90优选从第一末端92延伸至第二末端 94并且是具有纵轴线96和基本上环状截面的管状。应当理解,在其它实施方式中,支架可以具有非环状截面,例如D形、椭圆形或另外的卵形横截面形状。在示出的实施方式中,在支架框架90的第一末端92和第二末端94处均设置有多个间隔开的小孔(眼孔)98。可以在没有这样的小孔98的情况下构造其它实施方式。

[0072] 示出的支架框架90具有非前缩部分100和前缩部分110。这些部分在第一和第二末端92、94之间的过渡区(过渡段)112处接合。前缩(透视缩短,投影缩短,缩短, foreshortening)是指随着支架的半径从收缩状态增加至扩张展开状态,前缩部分110中支架90的长度减小的行为。因此,在示出收缩状态的支架框架90的图4A中,该支架框架 90的前缩部分110比在图4B中示出的当该支架处于扩张状态时更长。

[0073] 继续参考图4B,示出的支架框架90的非前缩部分100包括以锯齿形图案布置的多排或多个环lHa-c的圆周(环形)可扩张的组件(元件)或支柱115。将支柱115构造成随着支架90半径的变化而扩张和收缩。在示出的实施方式中,所述支架具有三个这样的环lHa-c。应当理解,如果需要可以使用更多的或更少的环以达到该支架框架的目的。在示出的实施方式中,各圆周(环形)波状支柱115的各自的末端在顶点116、118处与相邻的支柱115连接(接合),所述顶点在至少一些实施方式中是优先弯曲的区域。在示出的实施方式中,第一环114a和第三环IHc的锯齿形图案通常彼此同相,而第一和第三环114a、 114c之间的第二环114b的支柱115通常与第一和第三环不同相。应当理解,在其它实施方式中,当需要时,所有或大部分环可以彼此同相或不同相。

[0074] 继续参考图4B,纵向支柱120跨过非前缩部分100的环IHa-C从框架90的第一末端92横向延伸至过渡区112。更具体地,每个环114共用相同的纵向支柱120。纵向支柱120延伸通过邻近环114的顶点116,并优选延伸非前缩部分100的整个长度。优选地, 纵向支柱120包括非扩张的杆或条。连接至纵向支柱120的顶点116称作“连接的”顶点 116。未连接至纵向支柱120的顶点118称作“空置的(自由)”顶点118。

[0075] 如上文所述,纵向支柱120在纵向方向上基本上不扩张。因此,尽管波状支柱115 提供在径向扩张或收缩时的柔性,但是由于支架90在收缩和扩张状态之间改变径向尺寸, 因此非前缩部分100中支架的纵向长度基本上保持不变。在其它实施方式中,纵向支柱可以包括可以使所述支架稍微纵向扩张的可扩张元件。然而,这样的纵向扩张将不直接依赖于支柱半径的任何变化。

[0076] 继续参考图4A和图4B,示出的支架框架的前缩部分110包括第一和第二圆周环(环形环)12^、lMb,其均由互连的网格(cells) 130构成。各网格130包括多个支柱构件 (支柱件)132,所述支柱构件以这样的方式互连使得当支架径向扩张时,网格130变得纵向更短。在示出的实施方式中,各网格130是闭合的并且被构造成通常为菱形的图案。圆周(环形)和纵向网格连接体(connectors) 134、136使相邻的网格130彼此连接。第一环 124a中各网格130的上端140在过渡区112处连接至非前缩部分100的相应纵向支柱120 的第二末端142。

[0077] 尽管示出的前缩网格130被排列成菱形图案,但应当理解,可以采用其它构造。例如,在其它实施方式中,所述前缩网格通常可以为椭圆形,并且在另外的实施方式中,所述网格可能不是完全封闭的。如上文所讨论以及图4A和图4B中所示出的,当示出的支架90 从收缩状态扩张至扩张状态时,支架的非前缩部分100基本上保持相同的长度,而支架的前缩部分110的长度变得基本上更短。

[0078] 继续参考图4A和图4B,多个第一锚(锚形体,锚状物)150从过渡区112延伸到前缩部分110中。优选地,每一个锚150还通常从支架90径向向外延伸,使得每个第一锚 150的尖端152与网格130间隔开。类似地,多个第二锚巧4从支架框架90的第二末端94 处或邻近支架框架90的第二末端的前缩网格130延伸,并且延伸到前缩部分中并从该支架径向向外延伸,使得每个第二锚154的尖端156与网格130间隔开。在当支架90处于收缩状态时相对的第一和第二锚150、154的尖端152、156之间限定第一距离,并且在当支架90 处于扩张状态时相对的第一和第二锚150、154的尖端152、156之间限定第二距离。如图所示,第二距离显著小于第一距离。这种排列(布置)使得前缩部分110通过它的锚150、154 抓握在组织上从而使支架保持在适当的位置。

[0079] 在优选的实施方式中,可以将支架90在心脏瓣膜环内展开,并在收缩时定位,使得相对的第一和第二锚150、154的尖端152、156设置在天然瓣膜环的相对侧。当该支架扩张时,相对的第一和第二锚被拉得更靠近,从而抓住天然瓣膜环的相对侧并牢固地使支架保持在适当的位置。因此,在不需要对天然瓣膜环的较大的径向力的情况下,可以使支架牢固地保持在适当的位置。于2009年8月27以美国公开号2009/0216314公开的申请人的共同未决美国专利申请系列第12/084,586号讨论了具有锚的前缩支架的实施方式,并且可以参考用于示出的支架实施方式的某些方面的进一步讨论。共同未决申请中关于前缩支架,特别是具有锚的前缩支架的实施方式的结构和操作的讨论明确地通过引用结合于本文。

[0080] 在示出的实施方式中,所述支架由形状记忆合金,特别是镍钛诺制成。然而,应当理解,可以适当地采用包括金属、金属合金和非金属的其它材料。

[0081] 在优选的实施方式中,最初以环状截面的镍钛诺管提供所述支架框架。该管是根据对应于支柱、网格等的图案进行激光切割的。优选对切割的管进行电化学抛光以便除去粗糙的边缘。可以根据期望的方式对切割和抛光的镍钛诺管进行成形,例如对锚进行成形以径向向外延伸,并且可以对该镍钛诺支架框架进行热处理以建立形状记忆并获得期望的弹性属性。

[0082] 接着具体参考图5,其示出了置换心脏瓣膜160的实施方式,其中图1-3的瓣膜体 30设置在图4的支架框架90上。在该实施方式中,将瓣膜体30的裙端部分40设置在支架90的外部并且将小叶部分50设置在支架90内。下游环76和小叶支撑物80连接至支架90。适当地通过裙端40形成孔162以容纳锚150、154。将锚150、巧4和相应的孔162 构造成使得当支架90收缩时,所述锚仍然延伸通过该孔。更具体地,当支架90收缩并且前缩部分110延长时,锚150、巧4在相应的孔162内移动,但是锚尖端152、156不会退出(离开)孔162。

[0083] 在一个实施方式中,在制造过程中,在小叶部分50的任何部分连接至裙端部分40 之前,使裙端部分40连接至支架90。在一些实施方式中,在折叠小叶部分40之前,将裙端部分40安装在(套在)支架90上。在其它实施方式中,在将小叶部分和裙端部分折叠后, 使所述支架在它们之间滑动。将支架90夹在小叶部分50与裙端部分40之间后,小叶M 连接至小叶支撑物80并且连合片60连接至下游环76。在一些实施方式中,进行这些的连接(结合),使得在支架为前缩的同时,至少部分瓣膜体可以相对于支架移动。

[0084] 在另一实施方式中,瓣膜体30的裙端部分40连接在支架90外,并且所述支架和瓣膜体被压缩成收缩状态,而小叶部分50没有相对于裙端部分40被折叠。因此,小叶部分 50不与支架50接触或不直接连接至支架50。在将置换瓣膜在患者体内展开的程序(操作) 中,将部分完全的组件推进到适当的位置,并且扩张支架使得锚抓住患者的天然瓣膜环。然后折叠瓣膜的小叶部分50并折入支架90中,然后原位(在适当的位置)连接至裙端部分 40。

[0085] 接着参考图6A-C,示出了心脏瓣膜200的另一实施方式,其中支架框架290被夹在瓣膜体230的内层250与外层240之间。在优选的实施方式中,瓣膜体230由包绕在支架框架290周围的单片组织形成,使得裙端部分240是外层并且位于支架290之外并连接在290之外。小叶部分250是内层。其位于支架四0内部并连接至裙端部分M0。在示出的实施方式中,分别将小叶254的第一和第二侧边沈4、266牢固地缝合至小叶支撑物部分 280的第一和第二侧边272、274。小叶部分250的连合片260连接至裙端部分MO的下游环276。在这种排列(布置)中,小叶部分250与裙端部分240之间的连接牢固地束缚住支架四0,而且还防止渗漏。另外,与连合片260结合(连接)的下游环276有助于分配在瓣膜闭合期间施加在连合片上的力。

[0086] 在图6A-C中示出的实施方式中的支架锚250、2M延伸通过瓣膜体230的上游环 278中的孔沈2。在示出的实施方式中,所述支架锚250、2M具有朝向它们的尖端252、256 的加宽的部分。因此,在支架四0的前缩部分210的延伸的过程中,其中锚250、2M被彼此拉开,锚的扩展部分(enlarged portions) 285帮助防止组织瓣膜体230从锚中滑出或更具体地,防止锚尖端252、256滑动通过与它们结合的孔沈2。

[0087] 在另外的实施方式中,可以将如图6A-C或如图1-4所示的瓣膜体230、30安装到扩张后并不前缩的支架框架上。如在上面的实施方式中,可以将裙端40、240设置在支架框架之外,并且将小叶部分50、250倒置并折叠使其位于支架框架内,但是与裙端部分对齐。 然后将小叶部分和裙端部分适当地缝合在一起,使得至少部分支架框架夹在所述部分之间。优选地,所述瓣膜体材料在裙端部分与小叶部分之间的折线处是连续的,其位于心脏瓣膜的上游末端或与其相邻,因此进一步降低了瓣膜周围渗漏(paravalvular leaks)的可能性。

[0088] 接着参考图7-9A,描绘了瓣膜体330的另一实施方式。图7公开了用于切割平展源组织以组装成瓣膜体实施方式的平展图案332。所示出的瓣膜体图案332具有第一和第二末端334、336,并且限定了裙端部分340和小叶部分350。所述小叶部分350包括三个小叶354,各具有下游小叶边缘362以及相对的第一和第二小叶侧边364、366。在相邻的小叶 354之间切割孔368并除去切割掉的组织以便限定小叶354。

[0089] 每一个小叶邪4具有第一和第二相对的连合片部分360、361。在示出的平展图案 332中,最初作为相邻小叶之间的连接363共形成相邻小叶354的连合片部分360、361。在按照平展图案切割的过程中,切割相邻小叶邪4之间的该连合连接363以便限定相邻小叶的第一和第二连合片360、361,所述第一和第二连合片360、361分别具有第一和第二切割末端370、371。在示出的实施方式中,在各小叶侧边364、336与相邻的连合片360、361之间切割相对小的凹入部分(jog)或偏移(offset) 374。

[0090] 继续参考图7,优选地,瓣膜体330的裙端部分340基本上是连续的,没有显著的切口例如图1-4瓣膜体的窗口。裙端340具有下游边缘376,并且在折线352处与小叶部分 350连接。在裙端部分340中,将瓣膜图案的第一和第二末端334、336切割成相对于下游边缘376是斜的,所述下游边缘376优选与折线352平行。在示出的实施方式中,在裙端部分 340内切割连合缝380,使得其通常与相邻的第一和第二连合片360、361的切割边缘370和 371对齐。

[0091] 接着具体参考图8,通过以下来构造瓣膜体330 :沿折线352相对于小叶部分350 折叠裙端部分340,并将裙端部分340的斜线末端334、336固定在一起以建立瓣膜体330的管形。在这种排列中,裙端部分340的内表面382面向小叶354的外表面384,并且通过裙端部分340的内表面382来限定瓣膜体330的内部386。相邻小叶354的第一和第二连合片部分360、361的内表面彼此接合(衔接),并且接合的片360、361穿过裙端部分340的相应连合缝380。还具体参考图9A,其为从裙端部分外获得的特写图,布置接合的第一和第二连合片部分360、361使得它们的切割末端370、371通常径向朝外并且与裙端部分340的外表面390相邻。

[0092] 接合的连合片部分360、361彼此连接,优选通过缝合线(sutures) 392彼此连接。 在示出的实施方式中,使直接围绕缝380的缝边缘部分394与连合片360、361的外表面396 接合,使得缝380的切割边缘397与片360、361的切割末端370、371 —样径向朝外。然后如图9A所示将缝边缘部分394和接合的连合片360、361均缝合在一起。

[0093] 在示出的实施方式中,缝边缘部分394中的裙端340的内表面382与片360、361 的外表面接合。在另外的其它实施方式中,首先将接合的连合片360、361 —起缝合在裙端 340外,然后将已缝合在一起的连合片360、361缝合在缝380周围的组织上。在另一实施方式中,未将接合的连合片360、361相互缝合。相反,将各片折叠与其切割边缘370、371相邻从而与邻近缝380的裙端部分340的外表面390接合,然后缝合至裙端。在另一这样的实施方式中,还可以将连合片360、361的接合部分缝合在一起或通过夹子等固定在一起。

[0094] 继续参考图7-9A,还将第一和第二小叶侧边364、366缝合至裙端部分340。因此, 在小叶3M与裙端部分340之间缝合了良好的密封(封口)从而防止瓣膜的操作过程中其间的任何血液渗漏。图9A和图9B示出了沿着第一和第二小叶侧边364、366将小叶3M连接至裙端的第一和第二接缝(缝合线,seams) 398,399.

[0095] 小叶侧边364、366与片360、361之间的偏移(offset) 374促进延伸通过连合缝 380的片与缝合至裙端部分340的内表面382的小叶侧边之间的清晰的过渡区。优选地,偏

12移374中的小叶边缘也与裙端接合。

[0096] 可以通过多种方式将瓣膜体330缝合在一起。在另一实施方式中,可以使用连合缝380作为在将小叶部分350折叠到裙端部分340上期间的指引(导向装置,guide),并且操作者应小心地确保小叶391适当地对齐。在另一实施方式中,在使瓣膜体形成为管之前但是在折叠之后,将至少一个并且优选至少两个小叶3M缝合在裙端340上。将仍处于变平状态时的小叶缝合至裙端可以是更方便的。该方法还能够使得相对于裙端340将小叶 354可靠地放置在正确的位置,并且在缝合期间使它们保持在正确的位置。而且,由于在通过将第一和第二裙端末端334、336连接使瓣膜体330形成为管之前,已经将至少一个小叶牢固地缝合在适当的位置,因此先前连接的一个或多个小叶起辅助适当放置和缝合剩余小叶的指引和参照点的作用。

[0097] 当然,在其它实施方式中,可以在折叠前和/或在将小叶350连接至裙端部分340 之前将瓣膜体330卷成管。例如,在一个实施方式中,一旦将瓣膜体330卷成管就使连合片 360,361结合并放置在适当的位置。一旦固定在适当的位置,片360、361则用作在将小叶 354结合至裙端340的同时辅助使它们保持在正确位置的指引。

[0098] 在另一实施方式中,提供了瓣膜体330,其具有与图7和图8的瓣膜体基本相同的结构,不同之处在于,图7中切割以形成相对的连合片360、361的相邻小叶3M之间的连合连接363没有切口,但是继续作为连接相邻小叶3M的连合片363。可以基本上如上文所述来构造这样的实施方式;然而,仅第一和第二图案末端334、336的连合片360、361具有切割边缘370、371从而如图A所示进行构造。

[0099] 具体参考图9,在小叶3M之间具有连续的连合片363的实施方式中,优选将每一个片363折叠使得片363的内表面接合。被折叠的片363穿过相应的连合缝380。优选以类似于上面讨论的实施方式的方式,将每一个折叠的连合片363缝合至裙端部分340。

[0100] 接着参考图10,示出了用于从平展源组织切割瓣膜体430的平面图案432的另一实施方式。在该实施方式中,将瓣膜体430分成裙端部分440和小叶部分450。小叶部分 450包括三个小叶454,每一个具有弯曲的下游小叶边缘462以及弯曲的第一和第二侧边 464、466。在每个小叶妨4上还限定了相对的第一和第二连合片部分460、461。在示出的图案中,通过除去小叶4M之间(包括相邻小叶的相邻的第一和第二片部分之间)的组织来形成连合片部分460、461和侧边464、466。三个连合槽(commissuralslots) 480切入基本上对应于连合片460、461的位置(布置)的裙端部分440中。通过切割并除去一部分的组织来形成示出的实施方式的槽480,与一些其它实施方式中简单地切割缝相反。一旦从源组织被切割下来,则可以以与图7-9的瓣膜体330相似的方式来构造瓣膜体430。

[0101] 接着参考图11,示出了支架框架500的另一实施方式。在示出的实施方式中,支架框架500包括非前缩部分510和前缩部分520。该非前缩部分510包括在顶点5沈、5观处彼此连接的波状圆周扩张的支柱524的三个环52h-522c。纵向支柱530具有第一和第二末端532、534,并且从支架500的第一末端538朝向第二末端539延伸,但是终止于从非前缩部分510至前缩部分520的过渡区M0。与纵向支柱530交叉的顶点被称作“连接的”顶点526,而连接的顶点526之间的顶点被称作“自由(空置)”顶点528。

[0102] 在示出的实施方式中,将第一环52¾设置成与支架的第一末端538相邻,并且将第二环522b设置成与第一环52¾相邻。在第二环522b的连接的顶点5¾处形成一组第一小孔(eyelets) 544。还在每一纵向支柱530的第二末端534处形成一组第二小孔M6, 支柱530在示出的实施方式中还是过渡区M0。在第三环522c中,自由顶点5¾各包括从其伸出的突起阳0,该突起还可以被称作顶点锚550。优选地,预成形第三环522c中的支柱 524,使得当支架框架500处于如图11所示的扩张状态时其径向向外张开。

[0103] 继续参考图11,示出的支架框架500的前缩部分520包括在连接体556处相互连接的通常为菱形的网格555的环552。各网格555的第一末端560连接至第二小孔546处的非前缩部分510。如上文讨论的实施方式,前缩网格555被构造成使得当支架框架500径向收缩时,支架的前缩部分520径向变长并且,相应地,当该支架框架径向扩张时,前缩部分520缩短。

[0104] 将前缩部分520中的各网格555的第二末端562连接至通常径向向外并朝向该支架的第一末端538延伸的锚570。在每一个锚570中,优选在各锚570的底部(kise) 574与顶端576之间形成锚孔(anchor eyelet) 572.在操作过程中,并与本文所讨论的其他实施方式一致,当将收缩状态的支架500置于天然心脏瓣膜环时,首先布置收缩的支架使得瓣膜环被设置在顶点锚550与锚顶端576之间。然后使支架500扩张,促使前缩,这使得锚顶端576更靠近顶点锚500并且抓握其间的天然瓣膜环。在示出的实施方式中,顶点锚500 不与末端锚570共线对齐。

[0105] 另外参考图12和图13,置换心脏瓣膜600的实施方式包括与如图11的支架框架 500结合的如图7-9的瓣膜体330。然而,在该实施方式中,整个瓣膜体330设置在支架500 内。更具体地,并且如图12所示,将瓣膜体330的裙端部分340缝合至该支架的第一小孔 5440在示出的实施方式中,将瓣膜体330的折线352折边(缝边),并且折边的缝610的某些缝线606也与支架500的非前缩部分510中的第一小孔544接合。在该示出的实施方式中,被折边的折线352成为瓣膜体330的上游末端612。

[0106] 继续参考图12和图13,将柔性的可纵向扩张的织物(纤维,fabric)的细长管状部分620连接至示出的实施方式中的裙端部分340的下游末端376。更具体地,通过下游接缝6M在约裙端部分的圆周将织物622的第一末端缝合至裙端部分的下游末端376。而且,织物620优选地连接至裙端340的外表面,并且还缝合在支架框架500的第二小孔546 上。优选地,还通过连接体缝线6¾在数个点处将织物620缝合至前缩网格555。

[0107] 在示出的实施方式中,织物620绕着支架框架500的第二末端539弯曲,通常沿着下游锚570的曲率。将织物部分620的第二末端6¾缝合至锚孔572。优选地,当支架 500在收缩状态和展开、松弛的扩张状态之间移动时,柔性织物620是足够扩张的以与前缩部分520 —起移动。因此,在示出的实施方式中,组织瓣膜体330被限定在支架的非前缩部分510并且柔性织物620跨过该支架的前缩部分520。因此,组织瓣膜体330没有经受支架 500的纵向扩张和收缩。

[0108] 在示出的实施方式中,仅在上游末端612处将瓣膜体330的组织部分直接缝合至支架框架500。将裙端部分340的下游边缘376结合至织物620,通过下游接缝6¾在第二小孔546处将所述织物直接缝合至支架500。在另一实施方式中,将织物620连接至裙端 340的相同接缝6¾还将裙端340连接至第二小孔M6。

[0109] 继续参考图7-9和图11-13,组装的心脏瓣膜600的示出的实施方式包括两层组织,优选由单一的连续组织片形成。仅将包括小叶354的瓣膜的小叶部分350直接缝合至裙端部分340。因此,在打开和闭合状态之间的瓣膜操作过程中,小叶部分350,具体地小叶 354,仅与裙端部分340直接接合。裙端部分340又与支架500和其他材料例如下游织物部分620结合并与其相互作用。

[0110] 应当理解,在其它实施方式中,可以通过提供组织瓣膜部分的较长的裙端部分来替换部分或所有的如图12和图13所示的实施方式中的织物部分620。还应当理解,在另外的实施方式中,示出的瓣膜体330可以与非前缩支架一起使用。

[0111] 接着参考图14,其描绘了安装在人心脏750内的如上文结合图12和图13讨论的心脏瓣膜600的示意图。以横截面示出了心脏,并且表示包括左心房752和左心室760的典型的解剖结构(anatomy)。通过肌肉壁762来限定左心室760。左心房752和左心室760通过二尖瓣环770彼此连通。在图14中还示意性地示出了天然二尖瓣前叶774,其具有将二尖瓣前叶774的下游末端连接至左心室760的肌肉壁762的腱索(chordae tendinae) 776。 左心室流出道778朝向左心室760的顶部延伸。

[0112] 如图14所示,根据先前讨论的支架500的对齐和展开方法,设置图12-13的瓣膜 600使得二尖瓣环770被抓握在锚570与顶点锚550之间。因此,所有或大部分的支架500 延伸到左心房中。可以将设置在环770上游的支架500的部分称作位于环上。通常位于环 770内的部分被称作位于环内。环下游的部分被称作位于环下。在示出的实施方式中,仅一部分的前缩部分位于环内或环下,并且支架500的剩余部分位于环上。

[0113] 在示出的实施方式中,在展开置换瓣膜600前未移除二尖瓣前叶774。优选地,在展开置换瓣膜前也未移除二尖瓣后叶(未示出)。然而,在其它实施方式中,可以在展开置换瓣膜之前移除这些天然瓣膜小叶之一或二者。

[0114] 在支架500被大部分在环上置于左心房752内时,支架500并不干扰泵吸期间左心室的功能。更具体地,支架500并不干扰从左心室760流动通过流出道(outflow tract) 778的血液并且不干扰在泵吸期间随着肌肉壁762收缩左心室760的变形。在示出的实施方式中,瓣膜体330与支架500结合使得瓣膜的下游边缘362基本上在二尖瓣环770 内。这被称作瓣膜体330的环内布置(放置)。

[0115] 接着参考图15,其是图解示出了另一实施方式的一部分支架500a和织物部分 620a的示意性截面侧视图。除了织物部分620a伸出锚孔57¾并直到锚尖端576a之外,该实施方式类似于图12和图13的实施方式。优选地,织物620a包绕在锚尖端576a周围并用环绕织物620a圆周的接缝将其固定在适当的位置,以便在锚570a的尖端576a处形成通常连续的带。这样,每个锚570a将通过织物620a与天然瓣膜环接触。

[0116] 参考图16A,示出了心脏瓣膜600a的另一实施方式。示出的心脏瓣膜600a采用了安装在与图11-13的支架500 (用于说明目的)非常相似的支架500b上的如上文结合图 7-9讨论的瓣膜体330。如图16A所示,与支架500几乎相同的支架500b包括大多数相同的结构并且使用相同的参考标号。结合上文支架500的论述来描述这样的结构。

[0117] 在示出的支架500b中,在支架500b的下游末端539处设置多个远端小孔800,所述下游末端539还是支架500b的前缩部分520中的网格555的第二末端562。在该实施方式中,瓣膜体330与支架500b结合,使得裙端部分340的下游边缘376例如通过缝线连接至下游小孔800。这样,小叶354,特别是小叶354的下游边缘362被排列(布置)在支架 500b的第二末端539,其附近,或者在一些实施方式中在支架500b的第二末端539的下游。[0118] 继续参考图16A,具有相对的第一和第二末端的812、814的细长管状柔性部分810 连接至瓣膜体330。更具体地,优选用环形(圆周)缝合818使柔性部分810的第二末端 814连接至裙端340的上游末端352。柔性部分810的第一末端812与支架500b在第一小孔544处结合。优选地,瓣膜体330的上游末端352不与支架500b直接结合,但是仅结合至柔性部分810,该柔性部分810又与支架500b连接。

[0119] 优选地,所述柔性部分810由柔性材料构成,随着支架500b的长度由于在径向收缩和扩张过程中的前缩而增加和减小,所述柔性材料的长度可以增加和减小。而且,优选地,瓣膜体330由诸如心包膜的材料构成,所述心包膜是柔性的但是仍然基本上不纵向伸展的。当所述瓣膜体由伸展的材料制成时,优选地,柔性部分810比瓣膜体330更易于纵向伸展,使得当支架500b的长度增加时,柔性部分810而不是瓣膜体330将纵向伸展,并且反之亦然。

[0120] 另外参考图16B,应当注意,在示出的实施方式中,一部分瓣膜体330跨过支架的前缩部分520。然而,可纵向伸展的柔性部分810设置在支架500b的非前缩部分510中。 当组装的瓣膜600a从图16A所示的扩张部分收缩成图16B所示的收缩状态时,前缩部分 500变得更长。由于瓣膜体330并不显著伸展,并且相反,在这样的伸长的过程中柔性部分 810显著伸展,所以支架500b相对于瓣膜体330纵向移动。这样的“漂浮瓣膜体(floating valve body) ”构造使得能够在支架500b的至少一部分前缩部分520上布置瓣膜体而不需在收缩和扩张过程中在瓣膜的前缩部分伸长过程中拉伸瓣膜体。

[0121] 在图16A和图16B示出的实施方式中,至少部分裙端340,优选在上游末端处或邻近上游末端,以可容纳收缩和扩张后瓣膜体330相对于支架500b的漂浮、纵向移动的方式例如通过一个或多个松散的缝线(stitches) 820松散地结合至支架500b的一个或多个纵向支柱530。在其它实施方式中,这样的松散的缝线820可在与瓣膜体相邻的柔性部分内。 优选地,缝线820是相对松散的使得当支架500b在收缩和扩张状态之间移动时,各缝线820 在相应的纵向支柱530上纵向滑动。有技巧地放置这样的缝线820使得存在用于缝线滑动的未干扰(稳定)的路径。

[0122] 在示出的实施方式中,柔性部分810由具有足够疏松的编织的织物(纤维)和/ 或能够在收缩过程中适应纵向伸展的材料构成,并且还能在扩张过程中当支架变短时拉紧松弛部分(拉直松弛的绳索)。然而,应当理解,其他类型的材料和构造可以用于柔性部分。 例如,在另一实施方式中,心包膜的细长管状部分构成了柔性部分。在该实施方式中,优选地,使所述心包膜折皱,使得当扩张过程中支架变短时优先以手风琴形式折叠。在另一实施方式中,所述柔性部分包括具有多个开窗(fenestrations)的心包膜区段,所述开窗是技巧性放置的缝,当向心包膜施加纵向应力(纵向张力)时,它们会变形从而使心包膜区段纵向伸展。然而,随着支架扩张和前缩,心包膜恢复至其原始状态。在瓣膜被展开后,并随着时间推移,向内生长的组织将辅助闭合所述开窗。在另外的其它实施方式中,可以采用其他另外的结构。例如,除了管状柔性部分外,所述柔性部分还可以包括与瓣膜体330的上游末端结合的弹性绳阵列,其在瓣膜收缩后纵向伸展并且当瓣膜扩张时拉紧松弛部分(拉直松弛的绳索)。而且,尽管示出的实施方式应用了具有两层的瓣膜体330,但是应当理解,其他实施方式可以应用与柔性部分连接并安装在具有前缩部分的支架上的单层瓣膜。

[0123] 接着参考图17,由安装在人心脏中的图16A和图16B的瓣膜600a构成了示意图。在示出的实施方式中,以与图14中描绘的支架500基本上类似的方式安装支架500b。然而, 将瓣膜体330安装在相对于支架更远的下游,使得小叶3M基本上位于二尖瓣环770内,该位置可以被称作环内或部分环内,因为小叶邪4的下游边缘362可以是环的下游,并且因此可以是环下。应当理解,在其它实施方式中,相对于支架可以将瓣膜体完全安装在环上、环内、环下或它们的组合。

[0124] 接着参考图18和图19,示出了瓣膜体630的又一实施方式。图18示出了用于从平展源组织切割瓣膜体630的平展图案632。如图所示,图案632包括裙端部分640和小叶部分650。所述小叶部分640包括三个小叶654,各具有下游边缘662以及相对的第一和第二侧边664、666。各小叶肪4具有相对的第一和第二连合片660、661。在各小叶侧边664、 666与相邻的连合片660、661之间提供偏移(offset) 674。

[0125] 在裙端部分640中,切割三个连合缝680使得通常与连合片660、661对齐。还在裙端部分640中切割第一和第二小叶边缘缝694、696使得基本上与相应的第一和第二小叶侧边664、666的曲率对齐。在示出的实施方式中,各连合片660、661的一部分700在下游方向延伸超过至少一部分小叶下游边缘662。

[0126] 继续参考图18和图19,为了由按照该图案632切割的平展组织构造瓣膜体630, 将切割的组织折叠并分别使第一和第二小叶边缘664、666推动通过(穿过)相应的第一和第二小叶缝694、696。小叶缝694、696处和邻近小叶缝694、696的裙端部分640的边缘优选被变形,使得缝694、696处和邻近缝694、696的裙端640的内表面与小叶654的内表面和外表面接合(衔接),从而使小叶切割末端704和相对的缝切割末端706、708径向朝外。 然后将小叶切割末端704和缝切割末端706、708缝合在一起。因此,将小叶边缘664、666连接至裙端640的缝合线基本上保持在裙端部分640之外,并且在使用过程中瓣膜体630内的小叶654的部分基本上不与该缝合线接合。类似地,并且以如在其它实施方式中所论述的方式排列相邻小叶654的第一和第二连合片部分660、661以使它们面对面地彼此接合, 延伸通过缝680并且在该缝边缘处将它们彼此之间以及与裙端640缝合在一起。

[0127] 在另外的其它实施方式中,所述小叶侧边664、666可以延伸通过相应的缝694、 696,被折叠以与裙端部分640的外表面703接合,然后被缝合在适当的位置。

[0128] 在示出的实施方式中,连合片部分660、661的下游部分700有助于用于将该连合片部分缝合在适当的位置的表面区域并提供在制造过程中抓握的材料。在一些实施方式中,将整个连合片660、661缝合至裙端640。在其它实施方式中,将一部分片缝合在适当的位置并且移除并丢弃各片的未使用的剩余部分。

[0129] 接着参考图20,示出了用于辅助构造图18和图19的瓣膜体630的工具830。工具 830具有近端手柄部分832和在其远端末端的模板(form) 840或模具(mold)。优选地,所述模板840被成形为与当小叶6M在闭合位置接合时瓣膜体630的下游部分的期望形状相反。示出的模板840包括停止表面(stop surface) 844和多个小叶接合表面(engagement surfaces) 850,其每一个具有第一和第二侧边854、856。

[0130] 另外参考图21,示出了在构造瓣膜体630的过程中的工具830。在优选的实施方式中,根据上文讨论的图案632切割瓣膜体630,然后使其形成为管并在连合片660、661处连接。优选地,开始仅将所述连合片660、661钉在适当的位置,因此用作在模板840上布置部分组装的瓣膜体630的指引(guide)。然后将部分组装的瓣膜体630的下游末端置于模板840上,使得裙端640与该模板的圆周外表面(环形外表面)860接合,并且小叶6M与相应的小叶接合表面850接合,并且小叶654的第一和第二侧边664、666基本上与小叶接合表面850的第一和第二侧边邪4、856对齐。优选地,小叶654的下游边缘662位于模板 850的停止表面844或与其相邻。

[0131] 在优选的实施方式中,操作者将瓣膜体630正确地定位在模板840上,并牵拉小叶 654的侧边664、666通过裙端部分640的相应的小叶缝694、696,优选它们均与小叶接合表面侧边邪4、856对齐。以这种方式,部分组装的瓣膜体630变得与模板840接合,具有该模板的形状,使得在优选的接合位置构造小叶。因此,可以在最佳瓣膜性能所需的精确位置构造瓣膜体630。一旦将瓣膜体630适当地定位在模板840上,在使小叶边缘664、666牵拉通过(穿过)相应的小叶缝694、696的情况下,以包括如上文讨论的方法的任何可接受的方式沿着缝694、696将小叶边缘664、666缝合至瓣膜体630或以其它方式结合至瓣膜体 630。另外,在其中开始仅将连合片钉在适当的位置的实施方式中,它们于是被完全固定在适当的位置。

[0132] 如上面讨论的瓣膜组装工具830的使用使得能够以相对快的方式提供瓣膜体的一致且理想成形的构造。在一个实施方式中,提供一种形成同源组织瓣膜体的方法,其中临床医生收获患者自身的组织例如患者自身的心包膜,将同源的源组织弄平,根据期望的心脏瓣膜图案对其进行切割,然后使用瓣膜体组装工具830组装该瓣膜体。优选地,可以在手术室中在单个操作(程序)中由临床医生形成该瓣膜,然后将其植入。

[0133] 接着参考图23,瓣膜体930的另一实施方式可以通常使用如上面结合图7_9所讨论的非常相同的构造的图案和方式来形成,除了从各小叶354的下游边缘362延伸出多个腱索932、934。在示出的实施方式中,提供了一个中心腱索和两个侧腱索932、934。优选地,所述中心腱索932比侧腱索934要长。在其它实施方式中,可以提供更多的或更少的腱索。在示出的实施方式中,作为图案的一部分切割腱索932、934,因此与相关的小叶354毗邻。优选地,安装片936位于各腱索932、934的顶点。安装片936优选包括直径增加的区域,其将提供容纳安装介质938,诸如支柱、夹子等的空间。

[0134] 图23是应用了与支架902结合的瓣膜体930的置换瓣膜900的示意图。优选地, 腱索932、934结合至瓣膜体下游的支架902,其在图23中以闭合状态示出。与天然腱索一样,优选地,腱索932、934足够长以使小叶3M在很少或没有干扰的情况下完全接合,但是还提供心室泵血过程中血压(血液压力)的分布。更简单而言,该腱索将血压从小叶传递至框架902。

[0135] 另外参考图对,其提供了可用于支撑瓣膜体930和腱索932、934的支架902的一部分。该示出的支架与上文所述的支架500类似。优选地,在该支架的远端末端539处或其附近形成多个远端小孔940。在示出的实施方式中,每一个远端小孔940均具有横向延长的孔942,其具有基本上平坦的接触表面944。将结合(连接)小孔950设置在纵向支柱 530上,优选在包括顶点锚550的环522c上。

[0136] 具体参考图25,示出了描绘一部分瓣膜体930、支架902和腱索932的示意图。如图所示,优选地,瓣膜体的下游末端通过支柱连接至第二小孔M6,与上文所讨论的实施方式类似。用假想线并以接合状态示意性地示出了瓣膜体小叶354。在该示出的实施方式中, 腱索932从小叶伸出并通过下游小孔940。在一些实施方式中,可以将该腱索缝合至下游小孔940。然而,在该示出的实施方式中,腱索延伸通过该小孔,与接触表面940接合,逆转路线(进程)并延伸至结合小孔950。优选地,利用例如缝合线938使腱索932的安装片936 结合至结合小孔950。以这种方式,当来自血压的力推压(推靠)闭合瓣膜的接合小叶时, 该腱索将这样的压力分布至支架的前缩部分的下游末端,以及还分布至该支架的前缩部分的上游末端,其不仅分布来自小叶的力,而且还促使支架锚550、570甚至更牢固且可靠地抓握天然瓣膜环。当然,应当理解,可以应用腱索结合的其它具体区域。 [0137] 虽然已在某些优选的实施方式和实施例的范围内公开了本发明,但是本领域技术人言应当理解,本发明除了具体公开的实施方式外还包括本发明的其它可替换的实施方式和/或用途以及其明显的更改和等同物。另外,虽然已经详细地示出和描述了本发明的许多变型,但是基于该公开内容,属于本发明的范围内的其他更改对于本领域技术人员来说是显而易见的。事实上,本文具体公开的实施方式被用作描述可在多个实施方式中应用的某些发明特征的载体。因此,可以预期,可以进行具体实施方式的具体特征和方面的各种组合或子组合并且仍落在本发明的范围内。例如,图7-9的瓣膜体已经被描述在切割相邻连合片的实施方式中(参见图9A)和未切割小叶之间的连合连接的实施方式中(参见图9B)。 然而,与图10的瓣膜体实施方式相关的讨论并没有具体描述小叶之间的连合连接未被切割的实施方式。由于申请人设想组合和/或替换所讨论的实施方式的特征,所以应当理解, 申请人还设想采用未切割的连合连接的图10瓣膜体的变型。该实例适用于本文与具体实施方式结合描述的所有特征。因此,应当理解,所公开实施方式的各种特征和方面可以彼此组合或替换以便形成本公开发明的不同方式。因此,预期本文公开的本发明的范围应不限于上文所讨论的具体公开的实施方式,而是仅应通过合理阅读所附的权利要求来限定。

Claims (18)

1. 一种置换心脏瓣膜,包括:包括外层和内层的瓣膜体;所述外层是管状的并且具有纵轴线、上游末端和下游末端,所述外层由薄的柔性材料形成;所述内层通常为管状,具有通常与所述外层共线的纵轴线,并且定位在管状外层内,所述内层由薄的柔性材料形成并限定适于在打开状态与接合状态之间移动的多个小叶,每个小叶具有侧边和下游部分,所述内层的相邻小叶通过连合部分连接;其中,所述小叶沿着所述小叶侧边附着于所述外层,并且所述连合部分附着于所述小叶侧边的至少一部分下游的外层。
2.根据权利要求1所述的置换心脏瓣膜,其中,所述内层和外层由柔性材料的单一连续切片构成。
3.根据权利要求2所述的置换心脏瓣膜,其中,使所述内层和外层在所述上游末端处相对于彼此折叠,使得所述内层与所述外层在所述上游末端处邻接。
4.根据权利要求1所述的置换心脏瓣膜,其中,所述外层包括连合缝,并且所述内层的所述连合部分之一的边缘至少部分地延伸通过所述缝。
5.根据权利要求4所述的置换心脏瓣膜,其中,所述外层包括被成形为补充相应的小叶侧边的小叶缝,并且所述小叶侧边至少部分地延伸通过所述缝。
6.根据权利要求1所述的置换心脏瓣膜,其中,所述外层具有多个穿过其中形成的窗口,所述窗口被构造成使得当所述小叶处于接合状态时,血液可以容易地流过所述窗口。
7.根据权利要求1所述的置换心脏瓣膜,所述置换心脏瓣膜另外包括可以径向压缩至压缩状态并且径向扩张至扩张状态的细长支架,所述支架具有纵轴线,并且其中所述瓣膜体附着于所述支架。
8.根据权利要求7所述的置换心脏瓣膜,其中,所述外层在所述支架的外侧,并且所述内层在所述支架的内侧,使得所述支架被夹在所述内层与外层之间。
9.根据权利要求7所述的置换心脏瓣膜,其中,定位所述瓣膜体使得所述支架与所述外层的外表面相邻。
10.根据权利要求9所述的置换心脏瓣膜,其中,所述瓣膜体的所述外层连接至所述支架,并且所述瓣膜体的所述内层直接连接至所述内层,但不直接连接至所述支架。
11.根据权利要求9所述的置换心脏瓣膜,其中,当所述小叶处于打开位置时,所述外层插入在打开的小叶与所述支架之间。
12.根据权利要求7所述的置换心脏瓣膜,其中,所述支架具有前缩部分,所述前缩部分被构造成使得当所述支架径向压缩时,所述前缩部分纵向扩张,并且当所述支架径向扩张时,所述前缩部分纵向收缩。
13.根据权利要求12所述的置换心脏瓣膜,其中,将至少一部分所述瓣膜体至少部分地设置在所述前缩部分内,并且所述瓣膜体在一个或多个连接点处附着于所述支架,所述连接点通常沿着所述支架的纵轴线与轴点对齐,使得在前缩过程中,所述支架相对于所述瓣膜体纵向移动而没有纵向拉伸或挤压所述瓣膜体。
14.根据权利要求13所述的置换心脏瓣膜,所述置换心脏瓣膜另外包括与所述支架和所述瓣膜体直接连接的纵向扩张材料,所述柔性材料在一个或多个与所述轴点纵向隔开的连接点处与所述支架直接连接。
15.根据权利要求12所述的置换心脏瓣膜,其中,所述支架另外包括非前缩部分,并且所述瓣膜体保持在所述非前缩部分内。
16. 一种制造置换心脏瓣膜的方法,包括:提供平展、柔性的源材料;根据期望的图案切割所述平展材料,所述图案限定第一和第二图案末端、裙端部分、以及小叶部分,所述小叶部分限定多个小叶、在相邻小叶之间延伸的连合部,并且每个小叶具有侧边;使所述第一和第二图案末端毗连从而使所述平展材料形成为管;沿着折线相对于所述裙端部分折叠所述小叶部分使得所述小叶部分基本上位于所述裙端部分内;使所述连合部附着于所述裙端部分;以及使所述小叶侧边附着于所述裙端部分。
17.根据权利要求16所述的制造置换心脏瓣膜的方法,所述方法另外包括提供具有与闭合状态的瓣膜的期望形状基本相反的形状的模板,所述模板具有小叶成形部分,并且在使所述平展材料形成为管并且使所述连合部附着于所述裙端部分之后,将所述瓣膜放置在所述模板上使得所述小叶与所述小叶成形部分接合,并且当所述小叶与所述小叶成形部分接合时使所述小叶侧边附着于所述裙端部分。
18.根据权利要求17所述的制造置换心脏瓣膜的方法,所述方法另外包括在所述裙端部分中形成小叶缝,所述小叶缝通常对应于所述小叶的期望曲率,并且将所述瓣膜放置在所述模板上使得所述小叶与所述小叶成形部分接合,其包括使所述小叶侧边延伸通过所述裙端部分中的所述小叶缝。
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US9456896B2 (en) 2016-10-04
US20100082094A1 (en) 2010-04-01

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