CN202568532U - 可植入的人工瓣膜 - Google Patents

可植入的人工瓣膜 Download PDF

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CN202568532U
CN202568532U CN2011204674170U CN201120467417U CN202568532U CN 202568532 U CN202568532 U CN 202568532U CN 2011204674170 U CN2011204674170 U CN 2011204674170U CN 201120467417 U CN201120467417 U CN 201120467417U CN 202568532 U CN202568532 U CN 202568532U
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framework
pole
valve
artificial valve
valve according
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I·哈里顿
N·本尼楚
Y·尼赞
B·费尔森
D·源-天-纳
R·康纳
S·源
T·莱威
I·派利德
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Edwards Lifesciences Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—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
    • 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
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
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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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    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
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    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B1/00—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means
    • B05B1/14—Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means with multiple outlet openings; with strainers in or outside the outlet opening
    • B05B1/18—Roses; Shower heads
    • B05B1/185—Roses; Shower heads characterised by their outlet element; Mounting arrangements therefor
    • E—FIXED CONSTRUCTIONS
    • E03—WATER SUPPLY; SEWERAGE
    • E03C—DOMESTIC PLUMBING INSTALLATIONS FOR FRESH WATER OR WASTE WATER; SINKS
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    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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    • Y10T29/49826—Assembling or joining
    • Y10T29/49863—Assembling or joining with prestressing of part

Abstract

根据一个实施例，一种可植入的人工瓣膜(10)包括框架(12)、小叶结构(14)和裙部部件(16)。该框架可以具有由多个圆周支杆(22，24)相互连接的多个轴向支杆(20)。该小叶结构包括多个小叶(例如，布置三个小叶以形成三尖瓣)。该小叶结构具有固定于该框架的扇贝形下边缘部分。该裙部部件可以设置在小叶结构和框架之间。

Description

可植入的人工瓣膜
本申请是2009年6月8日提交的名称为“小外形经导管的心瓣膜”的中国专利申请200990100369.2(PCT/US2009/046646)的分案申请。 
技术领域
本实用新型涉及可植入的装置，更具体地说，涉及用于植入诸如自体心瓣膜环的身体导管中的瓣膜假体。 
背景技术
人的心脏遭受各种瓣膜疾病。这些瓣膜疾病可以导致心脏重大功能障碍并且最终需要用人工瓣膜替换自体瓣膜。有许多种已知的人工瓣膜和将这些人工瓣膜植入人体中的许多种已知的方法。 
各种外科技术可以用于修复患病的或损坏的瓣膜。在瓣膜置换手术中，损坏的小叶被切去并且环被修整成接纳替换瓣膜。由于主动脉狭窄和其他心瓣膜疾病，每年有成千上万的病人进行外科手术，其中有缺陷的自体心脏瓣膜用人工瓣膜(生物假体瓣膜或机械瓣膜)替换。另一种用于治疗有缺陷的瓣膜的不太剧烈的方法是通过修复或重新构造，这种方法通常用于极小的钙化的瓣膜。外科治疗的问题是由于与外科修复相关的高发病率和死亡率对这些慢性病人产生重大的损害。 
当置换瓣膜时，人造瓣膜的外科植入通常需要开胸外科手术，在此期间心脏停止并且病人被放置在心肺旁路(所谓的“心肺机”)上。在一种通常的外科手术过程中，患病的自体瓣膜小叶被切去并且人造瓣膜被缝合在瓣膜环的周围组织上。由于与手术过程以及体外血液循环的护理期间相关的创伤，一些病人不能在外科手术过程中活下来或者在手术后短时间死亡。众所周知，病人的风险随着体外循环所需要的时间量而增加。由于这些风险，相当数目的瓣膜有缺陷的病人由于其身体状况太虚弱不能经受外科手术过程而被认为是不宜手术的。一些估计认为，50％以上的80岁以上患有主动脉狭窄的受治疗者不能进 行主动脉瓣膜置换手术。 
由于与常规的开放心脏外科手术相关的缺点，经皮的和微创式外科方法受到高度关注。在一种技术中，人工瓣膜被配置为在很小的侵入手术过程中通过导管插入的方式被植入。例如，美国专利第5,411,522和6,730,118号公开了一种可收缩的经导管的心瓣膜，该心瓣膜能够以在导管上的压缩状态而被经皮地引入并且通过气囊膨胀或者通过利用自扩展框架或支架在希望的位置扩张，这些专利作为参考合并到本文。 
经导管的心瓣膜的一个重要设计参数是折叠的或卷曲外形的直径。卷曲外形的直径是很重要的，因为它直接影响外科医生将瓣膜推进通过股动脉或静脉的能力。更具体地说，较小的外形能够用于治疗更多的病人，且具有增加的安全性。 
发明内容
本公开涉及与诸如心瓣膜的人造瓣膜相关的新的、非显而易见的方法和设备。 
在一个代表性的实施例中，可植入的人工瓣膜包括径向可收缩的并且可扩张的框架或支架，以及包括多个小叶的小叶结构。该小叶结构具有位于该框架的里面并且固定于该框架的扇贝形下边缘部分。该瓣膜还可以包括环状的裙部部件，该裙部部件能够设置在框架和小叶结构之间，使得扇贝形下边缘部分能够连接于裙部部件的内表面。每个小叶可以具有上边缘、弯曲的下边缘和在上边缘和下边缘的相应端之间延伸的两个侧面片状物，其中每个侧面片状物固定于另一个小叶的相邻的侧面片状物，以形成小叶结构的接缝。每个接缝可以连接于其中一个接缝连接柱，并且加强杆可以设置为紧靠(against)每个侧面片状物，用于加强接缝和接缝连接柱之间的连接。 
框架可以包括多个成角度地间隔开的轴向支杆，该轴向支杆由多行圆周支杆相互连接。希望每行圆周支杆包括被布置为围绕框架的圆周以Z字形(zig-zag)或锯齿形图形延伸的支杆。 
在一些实施例中，至少一行(优选所有行)圆周支杆包括在两个轴向支杆之间延伸的圆周支杆对。该对支杆的每个支杆的一端连接于相应的轴向支杆，而另一端通过隆起部分相互连接于同一对的另一个 支杆的相邻端，使得在支杆的相邻端之间存在间隙。希望每对支杆之间的角度在90度和110度之间，其中大约100度是特殊的例子。希望框架用镍钴基的合金制造，例如镍钴铬钼合金(例如，MP35NTM)。 
在另一个代表性的实施例中，可植入的人工瓣膜包括径向可收缩并且可扩张的环形框架和由该框架支撑的小叶结构。该框架可以包括在框架中限定多个开口网眼(cell)的多个相互连接的支杆。该瓣膜还包括设置在框架的至少一部分上并覆盖框架的至少一部分网眼的环形外罩部件。希望该外罩部件包括诸如硅的弹性体，当瓣膜从卷曲状态扩张到扩张的状态时该外罩部件能够扩张并拉伸。 
外罩部件可以是围绕框架的至少一部分的由硅制成的薄套筒。可替换地，外罩部件可以通过将框架的至少一部分浸渍在液态形式的硅或其他合适的弹性体中形成。 
在另一个代表性的实施例中，公开一种用于卷曲具有框架和由框架支撑的小叶的可植入人工瓣膜的方法。该方法包括将瓣膜放置在卷曲装置的卷曲小孔中，使得可压缩的材料设置在该卷曲装置的卷曲爪和瓣膜的框架之间。用卷曲爪将压力施加在可压缩的材料和瓣膜上，以径向卷曲该瓣膜成较小的外形，并且将可压缩材料向瓣膜压紧以使得可压缩材料延伸到框架的开口网眼中，并且将小叶推离框架的内侧。 
根据本实用新型，提供一种可植入的人工瓣膜，其包括：径向可收缩并且可扩张的环形框架，该框架具有三个接缝连接柱和在所述接缝连接柱之间延伸的三行圆周支杆，第一行圆周支杆限定所述框架的流入端，而与所述第一行间隔开的第二圆周支杆和第三行圆周支杆邻近所述框架的流出端，所述第一行通过多个轴向支杆连接于所述第二行和所述第三行，每行圆周支杆包括成角度的支杆，该成角度的支杆布置成Z字形图形并且通过大致U形的隆起结构相互连接以便改进可收缩性；包括由心包组织形成的三个小叶的小叶结构，每个小叶具有上边缘、弯曲的下边缘和两个侧面片状物，其中每个侧面片状物固定于另一个小叶的相邻的侧面片状物，以形成所述小叶结构的接缝，每个接缝连接于所述接缝连接柱中的一个；设置在所述环形框架和所述小叶结构之间的环形的裙部部件，每个小叶的所述弯曲的下边缘沿着扇贝形路线缝合于所述裙部部件的内表面；以及邻近每个接缝连接柱 设置的成对加强杆，每个加强杆包括多个孔，其中每个侧面片状物围绕一个加强杆延伸，并且每个加强杆缝合于一个接缝连接柱，用于加强所述小叶结构和所述接缝连接柱之间的连接。 
根据本实用新型的另一个实施例，所述第一行和所述第二行圆周支杆具有平行的Z字形图形。 
本实用新型的前述和其他特征和优点从下面参考附图进行的详细描述中将变得更加明白。 
附图说明
图1是人工心瓣膜的代表性实施例的透视图。 
图2是图1的人工瓣膜的另一个透视图。 
图3是图1的人工瓣膜的另一个透视图。 
图4是图3所示的瓣膜的一部分的放大图。 
图5是图1的人工瓣膜的底视透视图，示出该瓣膜的里面。 
图6是图1的人工瓣膜的顶视平面图。 
图6A是图1的瓣膜的放大的局部顶视图，示出相对于框架的接缝连接柱的加强杆的设置。 
图7是图1的人工瓣膜的框架的透视图。 
图8是能够用在图1的人工瓣膜中的框架的可替换实施例的透视图。 
图9是图7所示的框架的120度分割部分的展开图。 
图10是图8所示的框架的120度分割部分的展开图。 
图11是加强杆的正视图，该加强杆能够用来加强将瓣膜小叶连接于诸如图1所示的人工瓣膜中的框架的连接。 
图12是图11的加强杆和能够用于覆盖该杆的PET套筒的透视图。 
图13是图1所示瓣膜的小叶的展开图。 
图14是小叶的相对侧的展开图，示出靠近小叶的底边缘而固定的加强带。 
图15是图1的瓣膜小叶结构在连接于框架之前的顶视平面图。 
图16是在图1的瓣膜中所用的裙部的展开图。 
图17是图16所示的裙部在相对端部互相连接以形成环形形状之 后的侧视图。 
图18是连接于裙部以便形成小叶组件的小叶结构的底视透视图。 
图19是气囊导管和卷曲在该气囊导管的气囊上的人工瓣膜的侧视图。 
图20是卷曲装置的正视图，示出设置在卷曲装置的卷曲小孔中的人工瓣膜，其中保护套筒设置在瓣膜和卷曲爪之间。 
图21是示出卷曲爪被向内施力以压紧瓣膜和保护套筒之后的卷曲装置的正视图。 
图22是从卷曲装置取出之后的瓣膜和保护套筒的侧视图。 
图23是卷曲在气囊导管的气囊上没有保护套筒的人工瓣膜的侧视图。 
图24是以图20-21的所示方式利用保护套筒卷曲在气囊导管的气囊上的人工瓣膜的侧视图。 
图25是用于人工瓣膜的框架侧视图，该框架具有设置在该框架外面的硅裙部或套筒。 
图26是用于人工瓣膜的框架的侧视图，该框架具有覆盖该框架里面和外面的硅密封层。 
图27是包括具有硅密封层的框架的人工瓣膜的透视图。 
图28是图27的瓣膜被卷曲成较小直径之后的透视图。 
图29是图27的瓣膜被气囊导管扩张之后的侧视图。 
图30A-30C是示出在相应的硅测试带上进行的相应的单轴测试的结果的曲线图。 
图31A-31F是示出在相应的硅测试带上进行的相应的单轴测试的结果的曲线图，该硅测试带具有故意引进的裂纹。 
具体实施方式
图1和图2示出根据一个实施例的可植入人工心瓣膜10。所示的实施例中的瓣膜10通常包括框架或支架12、由该框架支撑的小叶结构14以及固定于小叶结构的外表面的裙部16。瓣膜10通常被植入自体主动脉瓣膜的环中，但是也能够适于植入心脏的其他自体瓣膜或身体的各种其他管道或小孔中。瓣膜10具有“下”端80和“上”端82。 在本申请的上下文中，术语“下”和“上”与术语“流入”和“流出”可分别互换使用。因此，例如，瓣膜的下端80是其流入端，瓣膜的上端82是其流出端。 
瓣膜10和框架12被配置为快速地收缩成收缩的或卷曲的状态，用以在输送导管上引进身体中，并且被配置为可快速地扩张成扩张的状态用以将瓣膜植入身体中希望的部位(例如自体主动脉瓣膜)。框架12可以用使瓣膜能够卷曲成较小的外形的可塑性扩张的材料制造，以便通过使用诸如气囊导管的气囊的扩张装置输送并扩张瓣膜。能够用来形成框架的示范性的可塑性扩张的材料在下面描述。可替换地，瓣膜10可以是所谓的自扩张瓣膜，其中框架用诸如镍钛诺(Nitinol)的自扩张材料制造。自扩张瓣膜能够卷曲成较小的外形并且用诸如覆盖瓣膜的护套的约束装置保持在卷曲的状态。当瓣膜位于或接近目标部位处时，约束装置被去掉以使瓣膜能够自扩张到其扩张的功能尺寸。 
也参考图7(为了示意的目的，图7只示出框架)，框架12是环形的支架状结构，具有多个成角度地间隔开的、竖直延伸的接缝连接柱或支杆18。柱18经由圆周延伸的支杆20的下行36a和分别圆周延伸的支杆22和24的分别的第一和第二上行36b、36c相互连接。希望每行中的支杆设置成如图所示的沿着框架的圆周方向延伸的Z字形，或大体的锯齿状图形。同一行中相邻的支杆可以彼此相互连接，如图1和图5所示，以形成角度A，希望该角度A在大约90和110度之间，其中大约100度是特殊的例子。对90和110度之间的角度A的选择使框架12在扩张时的径向强度最优化，且仍然允许框架12以下面描述的方式均匀地卷曲。 
在所示的实施例中，在同一行中相邻的圆周支杆对通过相应的大体U形形状的隆起结构或隆起部分26彼此连接。每个隆起结构26包括在支杆的相邻端之间延伸并连接支杆的相邻端的水平部分，因此在相邻端之间形成间隙28，并且该隆起结构在偏离该支杆的正常交点的位置连接该相邻端。在框架12以下面所述的方式卷曲和扩张期间，隆起结构26明显减少框架12上在支杆20、22、24的位置处的残余应力。连接在共用隆起结构26处的每对支杆22与上面一行中的相邻的一对支杆24形成网眼。每个网眼在节点32能够连接于相邻的网眼。每个 节点32通过相应的竖直(轴向)支杆30能够与下一行的支杆相互连接，该竖直(轴向)支杆30连接于相应的节点32和下面一行支杆20上的位置并在其之间延伸，在该位置两个支杆在其与隆起结构26相对的端部被连接。 
在一些实施例中，下支杆20具有大于上支杆22、24的厚度或直径。在一个实施例中，例如，下支杆20具有大约0.42mm的厚度T(图9)，而上支杆22、24具有大约0.38mm的厚度T。由于在所示的结构中仅有一行下支杆20和两行上支杆22、24，所以下支杆20相对于上支杆22、24的增大在框架的下部区域增加框架的径向强度并且允许框架更加均匀的扩张。 
图9示出图7所示的框架12的120度分割部分的展开图，该分割部分包括在两个连接柱18之间延伸的框架的部分。如图所示，每个框架分割部分具有支杆的三个列34和三个行36a、36b、36c。每个列34由在两个轴向延伸的支杆18、30之间延伸的邻接的支杆对20、22、24形成。希望框架12包括三个120度分割部分，其中每个分割部分由两个连接柱18定边界。因此，在所示实施例中每个框架12包括总共包括9个列。 
希望列和行的数目最小化，以减小瓣膜的总的卷曲外形，如下面进一步讨论的。图7和图9的设置通常用于直径小于大约29mm的瓣膜，并且最适合于直径为约20-26mm的瓣膜。在包括框架12的瓣膜的工作例子中，20mm的瓣膜能够卷曲成约17Fr的直径，23mm的瓣膜能够卷曲成约18Fr的直径，而26mm的瓣膜能够卷曲成约19Fr的直径。对于约29mm或更大直径的瓣膜，可以希望增加支杆另外的行和列。 
例如，图8和图10示出可替换框架40，该框架40类似于框架12，除了框架40具有四个支杆行(最下的、支杆42的第一行52a，支杆44的第二行52b、支杆46的第三行52c和支杆48的最上行52d)而不是三个支杆行，以及用于每个120度的框架分割部分有四个支杆列50而不是三个支杆列之外。图10示出图8所示的框架40的120度分割部分的展开图。在所示实施例中框架40包括三个这种120度的分割部分，提供用于框架的总共12个支杆列50。 
希望第三行的支杆46与第四行的支杆48面向相反的方向(即顶点或隆起部分面向相反的方向)，以在瓣膜的卷曲和扩张期间帮助避免框架的竖直柱的弯曲。可以设置第二行支杆44以便如图所示与第一行的支杆42面向相同的方向(即，顶点或隆起部分面向相同的方向)。可替换地，第二行支杆44可以与第一行的支杆42面向相反的方向，以便分别像由第三和第四行的支杆46、48形成的网眼一样，形成方形网眼。框架40也可以包括轴向延伸的支杆54，支杆54连接于每个支杆42、44、46、48的端部并在其间延伸，支杆42、44、46、48在不连接于连接柱18的列50中对齐。正如上面所指出的，框架40最适合于直径为29mm或更大的瓣膜(当扩张到其功能尺寸时)。在包括框架40的瓣膜的工作例子中，29mm的瓣膜能够卷曲成约21Fr的直径。 
能够用于形成框架的合适的可塑性扩张的材料包括但不限于，不锈钢、镍基合金(例如，镍钴铬合金)、聚合物或其组合。在具体的实施例中，框架20用诸如MP35NTM(SPS Technologies的商标名称)的镍钴铬钼合金制造，MP35NTM相当于UNS R30035(被ASTM F562-02涵盖)。MP35NTM/UNS R30035按照重量包括35％的镍、35％的钴、20％的铬和10％的钼。已经发现，利用MP35N形成框架20提供优于不锈钢的高级结构效果。具体说，当MP35N用作框架材料时，实现相同的或更好的径向性能和抗压扁力性、抗疲劳性和耐腐蚀性需要较少的材料。而且，由于需要较少的材料，框架的卷曲外形可以减小，因而，提供用于经皮输送到身体中的治疗部位的较小外形瓣膜组件。 
再参考图1，例如，裙部16可以用聚对苯二甲酸乙二醇酯(PET)带状物(ribbon)形成。裙部的厚度可以变化，但是希望小于6密耳(mil)，而且希望小于4密耳，甚至更希望小于约2密耳。裙部16可以通过Lenzing缝合线56固定于框架12的里面，如图1所示。小叶结构14可以通过下面讨论的薄PET加强带68(或套筒)连接于裙部，薄PET加强带68能够固定缝合并且保护小叶结构的周围组织不受撕裂。如图所示，小叶结构14可以夹在裙部16和薄PET带68之间。将PET带和小叶结构14固定于裙部16的缝合线58可以是任何合适的缝合线，例如Ethibone缝合线。正如在下面更加详细地描述的，希望缝合线58沿着小叶结构14的底边缘的曲线就位。小叶结构14可以用本领域已 知的公开在美国专利6,730,118中的牛心包组织、可生物相容的合成材料或各种其他合适的天然或合成材料，该美国专利结合于此供参考。 
小叶结构14可以包括三个小叶60，小叶60能够设置成以三尖瓣结构收缩，如最佳示出在图2和图6。希望小叶结构14的下边缘具有波浪形的、弯曲的扇贝形形状(图1所示的缝合线路58沿着小叶结构的扇贝形形状就位)。通过用这种扇贝形的几何形状形成小叶，小叶上的应力减小，这进而又改善瓣膜的耐久性。而且，借助于扇贝形的形状，能够消除或至少最小化在每个小叶的凸部(belly)(每个小叶的中间区域)处的折叠和皱褶(ripple)，这些折叠和皱褶能够引起这些区域中的早期钙化。该扇贝形几何形状还减少用于形成小叶结构的组织材料的量，因而允许在瓣膜的流入端较小的更加均匀的卷曲外形。 
小叶60能够在其相邻的边被相互固定以形成小叶结构的接缝84(小叶合在一起的边缘)。可以用合适技术和机构将小叶结构14固定于框架12。例如，如图6最好地所示，希望小叶结构的接缝84与支撑柱18对齐并且利用缝合线将小叶结构的接缝84固定至支撑柱18。小叶连接于柱18的连接点可以用杆62(图11)加强，希望该杆用相对刚性的(与小叶相比)材料制造，例如不锈钢。 
图13示出单个的小叶60，小叶60具有弯曲的下边缘64和在小叶上边缘和下边缘之间延伸的两个片状物66。弯曲的下边缘64形成单个的扇贝形。当固定于两个其他的小叶以形成小叶结构14时，小叶的弯曲下边缘形成小叶结构的扇贝形下边缘部分(如图18最好地所示)。正如图13进一步示出的，两个加强杆62可以邻近片状物66固定于小叶(例如用缝合线)。然后片状物能够折叠在杆62上，并且用缝合线固定在折叠位置。如果希望，如图12所示，每个杆62可以在连接于小叶之前放置在保护套筒68(例如PET套筒)中。 
如图14所示，小叶的弯曲下边缘64为了后来固定于裙部16可以被加强，例如可以通过将加强带68沿着小叶的弯曲下边缘固定于在小叶相对杆62旁边的片状物66之间。三个这样的小叶60可以用相同的方式制造，并且然后以三尖瓣结构在片状物66处相互连接，以形成小叶结构14，如图15所示。小叶上的加强带68共同形成沿着小叶结构的内表面的下边缘部分延伸的带状物或套筒。 
正如上面所指出的，小叶结构14可以用裙部16固定于框架12。希望裙部16包括诸如PET的韧性的、抗裂纹的材料，尽管可以用各种其他天然或合成材料。裙部16可以比传统的裙部薄很多。例如，在一个实施例中，裙部16是PET裙部，在其边缘处具有约0.07mm的厚度，并且在其中间处具有约0.06mm的厚度。比较薄的裙部能够提供更好的卷曲性能同时仍然具有良好的瓣膜周边的密封。 
图16示出在相对两端相互连接形成图17所示的环形形状之前裙部的展开图。如图所示，希望裙部16的上边缘具有波浪形的形状，该波浪形的形状大致遵循框架的第二行支杆22的形状。以这种方式，裙部16的上边缘能够用缝线56紧固地固定于支杆22(如图1所示)。裙部16也可以形成有狭槽70，以便于将裙部连接于框架。当裙部固定于框架时狭槽70与支杆22的隆起结构26对齐。狭槽70的尺寸做成以便使裙部的上边缘部分能够围绕支杆22部分地被包裹，并且在连接过程中减少裙部中的应力。例如，在所示的实施例中，裙部16放置在框架12的里面并且裙部的上边缘部分围绕支杆22的上表面被包裹，并且用缝合线56固定在位。以这种方式围绕支杆22包裹裙部的上边缘部分提供裙部与框架的更强的和更耐久的连接。尽管没有示出，但是裙部的下边缘也能够做成与最下一行支杆22的外形大致相符的形状，以改善通过瓣膜的流入端的血液的流动。 
如图17进一步所示，各种缝合线路能够添加于裙部，以方便将裙部连接于小叶结构和框架。例如，扇贝形缝合线路72可以用作导向装置，以在适当的位置用缝合线59将小叶结构的下边缘缝合在裙部的内表面上(如图5最好地所示)。另一个扇贝形缝合线路74(图17)可以用作导向装置，以用缝合线58将小叶结构缝合于裙部(图1)。固定于小叶的下边缘的加强带68沿着缝合线路58加强小叶并且保护小叶不受撕裂。图18示出由裙部16和固定于裙部16的小叶结构14构成的小叶组件。然后该小叶组件能够以下面所述的方式固定于框架12。在可替换实施例中，没有小叶结构的裙部可以首先连接于框架，并且然后小叶结构可以连接于该裙部。 
图6示出连接于框架12的瓣膜组件的顶视图。小叶60在大致闭合的位置被示出。如图所示，小叶的接缝与框架的柱18对齐。利用延 伸通过小叶的片状物66、加强杆62的开口76以及柱18的开口78的缝合线，有效地将片状物66固定于柱18，小叶能够固定于框架。正如上面所指出的，杆62在与柱的连接区域加强片状物，并且防止小叶撕裂。 
如图6A所示，希望加强杆62垂直对齐，并且相对于框架的柱18尽可能直，使得杆62和在每个接缝处的柱18形成T形形状。杆62的宽度和通过杆的接缝的连接在小叶60的可偏转的部分(没有用缝合线缝合于框架的部分)和框架之间提供间隙，同时杆62的边缘半径(厚度)在瓣膜打开和关闭过程中用作小叶60的柔性铰链，因而增加小叶和框架之间的空间。通过增加小叶的运动部分和框架之间的空间，并且通过使小叶弯曲向杆62的边缘半径，在工作循环期间能够避免小叶的运动部分(具体说小叶的流出边缘)和框架之间的接触，这进而又改善瓣膜组件的耐久性。这种结构还增强通过冠状窦的灌注。 
图19示出卷曲在气囊输送导管100上的瓣膜10的侧视图。该瓣膜卷曲在气囊导管100的气囊110上。希望在卷曲期间保护瓣膜的小叶结构14不受损坏，以确保小叶结构的耐久性，同时希望尽可能减少瓣膜的卷曲的外形尺寸。在卷曲过程期间，小叶结构的组织(例如，牛心包组织或其他合适的组织)压向金属框架的内表面，并且该组织的(多个)部分能够挤进支杆之间的框架的开口网眼中，并且由于框架支杆的剪刀状的运动而能被夹紧。如果瓣膜被严密卷曲以实现小卷曲尺寸，那么这种剪刀状的运动能够导致该组织小叶的切割和破裂。 
上面所述的裙部16在卷曲成某种程度期间能够防止损坏小叶结构。但是，裙部的主要目的是结构性的，并且在一些实施例中不覆盖整个框架。因此，在这样的实施例中，在卷曲期间裙部可能不完全保护小叶结构，并且因此，框架仍然能够引起对小叶结构的损坏。 
图20和图21示出用于以进一步保护小叶不受损坏的方式将瓣膜无损伤卷曲在气囊上的卷曲装置的实施例。该卷曲装置(也叫做卷曲器)总的用附图标记200表示，具有尺寸做成接纳扩张状态的瓣膜的小孔202。图20示出完全打开或扩张状态的小孔202，其中瓣膜10设置在小孔202的里面。卷曲装置200具有多个卷曲爪206(在所示的实施例中为12个)，卷曲爪206被配置成径向向里运动，以围绕气囊导 管的气囊将瓣膜径向压缩(卷曲)成较小的外形。 
可变形的材料设置在框架外侧和卷曲爪206之间。在所示的实施例中，可变形的材料包括围绕瓣膜设置的保护套筒或覆盖物204，以便覆盖瓣膜的框架的外表面并且防止卷曲爪的硬表面直接接触瓣膜的框架。希望套筒204尺寸做成完全覆盖框架的外表面。希望套筒204用柔软的可弯曲并可压缩的材料制造。套筒可以用通常可得到的材料形成，包括但不限于天然的或合成的海绵(例如聚氨酯海绵)、由诸如聚氨酯或聚乙烯的合适的聚合物制成的泡沫材料，或任何各种合适的弹性体材料，例如聚氨酯、硅、聚烯烃或各种水凝胶等，仅作为几种示例。 
使用前希望将套筒存放在潮湿的环境中(例如浸没在盐水中)。在围绕瓣膜放置套筒204之后，瓣膜和套筒被放进卷曲装置200中，如图20所示。然后气囊导管的气囊110可以设置在瓣膜的小叶60内(图21)。图21示出围绕套筒204的卷曲爪206，套筒204又进而围绕瓣膜10的框架12和小叶结构14。气囊110通常放置在瓣膜的中心以便在瓣膜被植入体内期间瓣膜能够均匀地扩张。 
正如从图21所见，在卷曲期间，保护套筒204的海绵状材料伸进框架12的开口网眼中并占据这个空间，因而防止小叶结构14进入这个空间并且被夹紧或损坏。在卷曲完成之后，具有保护套筒的瓣膜从卷曲装置取出。然后套筒204能够轻轻地从框架剥离。由于在卷曲期间保护套筒向里压紧小叶结构并离开框架，瓣膜能够卷曲成小外形而不损坏小叶结构。 
图23和24示出通过利用保护套筒204得到的优点。图23示出不用保护套筒卷曲的人工瓣膜。虚线300表示小叶结构302已经被压紧在如上所述能够损坏小叶结构的框架304的支杆之间。 
相反，图24示出用保护套筒204而卷曲的人工瓣膜。在这个例子中，小叶结构302被向里压紧并离开框架304的内侧，因此，小叶结构不被夹紧或挤压在框架的支杆之间。 
因此，当使用保护套筒时由于小叶结构被推离框架，因此在卷曲过程中小叶结构不太可能被夹紧或切割。而且，当利用保护套筒时，能够实现非常有序的气囊-小叶-框架结构(从里向外)。当没有这种套 筒时，气囊、小叶和框架的一些部分在卷曲过程之后很可能重叠并且结果得到的结构是较不可预知和较不均匀的。 
除了上面所述的泡沫和海绵型保护套筒之外，也可以用由其他类型的可变形材料制成的套筒或保护层，以在瓣膜卷曲期间保护小叶不受损坏。在一个实施例中，例如，可变形材料(例如海绵、橡胶、硅、聚氨酯等)的层(例如矩形片)可以设置在每个卷曲爪206上，以便在卷曲时形成围绕瓣膜的套筒。可替换地，用诸如凝胶或气体的可流动、可变形材料填充的可变形包可以设置在每个卷曲爪上，用于卷曲时与瓣膜接触。此外，在许多其他织物材料或其他合适的材料中，可变形材料(例如套筒204)可以用薄PET布覆盖，以防止在卷曲期间可变形材料的颗粒物进入瓣膜中。 
人造瓣膜的裙部用于多种功能。在具体实施例中，例如，裙部起密封作用以密封并防止(减少)瓣膜周边泄漏，以将小叶结构固定到框架，并且保护小叶在卷曲期间和在瓣膜工作循环期间不受由接触框架所引起的损坏。上面所述的与人工瓣膜一起使用的裙部被描述为诸如PET布的织物。PET或其他织物基本上是无弹性的(即，基本上是不可拉伸的或不可压缩的)。这样，在某些实施例中的裙部限制瓣膜的最小可实现的卷曲直径并且在从卷曲直径扩张之后能够起皱。 
在例如下面讨论的可替换实施例中，人工瓣膜可以具有用可拉伸和/或可压缩材料(例如硅)制造的裙部。由于这种裙部的可压缩性，与具有不可压缩的裙部的瓣膜相比，该瓣膜能够卷曲成相对小的直径。而且，从卷曲状态扩张之后这种裙部可以恢复到其原来很少有或没有皱褶的平滑表面。 
图25示出框架12的实施例，框架12具有围绕框架外面完全延伸并覆盖框架外面的至少一部分的弹性的“外管”(over-tube)裙部或套筒340。在具体的实施例中，裙部340用硅制造，该裙部能够经受大变形同时保持其弹性。这种硅裙部可以是从外面覆盖框架12一部分的薄套筒。在所示实施例中，裙部的高度小于框架12的总高度，但是，裙部的高度可以变化并且不必是图25所示的高度。例如，裙部的高度与框架的高度相同或大于框架的高度，以便完全覆盖框架的外面。在可替换实施例中，裙部340可以用例如缝合线或粘结剂安装在框架的里 面。当安装在框架的里面时，裙部可以保护小叶不受框架里面擦伤。可以用来形成裙部或套筒的其他材料包括但不限于，PTFE(聚四氟乙烯)、ePTFE(膨体聚四氟乙烯)、聚氨酯、聚烯烃、水凝胶、生物材料(例如心包，或诸如胶原、明胶或透明质酸衍生物的生物聚合物)或其组合。 
在另一个实施例中，整个框架或其一部分可以浸渍在液化材料(例如、液态硅或上面描述的用于形成套筒340的任何材料，这些材料可以液化用于浸渍涂覆框架)中，以便将整个框架(或至少被浸没的部分)密封在硅中。图26是框架12的侧视图，该框架浸渍在硅中以形成密封框架的支杆并且填充支杆之间的空间的连续的圆柱形硅覆盖层342。图26示出在覆盖层被修整以除去延伸超过框架端部的多余的材料之前的覆盖层342。尽管不太希望，但是可以浸渍框架使得硅密封框架的支杆，但是不填充框架支杆之间的开口空间。 
图27示出包括框架402和安装在该框架里面(例如，如图所示用缝合线)的小叶结构404的人工瓣膜400的实施例。框架402具有呈硅覆盖层406形式的裙部，该裙部例如通过将框架浸渍在液体硅中形成。图27示出在其扩张状态的人工瓣膜400。在图28中，瓣膜400已经被卷曲成较小的外形。在卷曲期间，延伸过并且填充框架支杆之间的开口网眼的涂层406有效地向里推小叶结构404并且推离该框架，因而，保护小叶结构不被夹紧或撕裂。图29示出被气囊导管的气囊扩张之后的瓣膜400。 
为了测试所用硅的耐久性和抗拉性，进行若干个单轴测试。具体说，大约5×50mm的硅带(其厚度约为0.85mm)在单轴测试机中测试。图30A-30C示出硅带的单轴测试的结果的曲线图。此外，在带的中间位置和带的边缘有意地将裂纹引进硅带中，同时在单轴测试机上拉伸该带。裂纹通过在硅带中用针形成孔而被引进。图31A-31F示出具有故意引进的裂纹的硅带的单轴测试结果的曲线图。 
已发现，硅薄层的最终张力拉伸在500％以上并且具有有意引进的裂纹的试验样品同样表现出很好的强度。因此，硅的弹性允许硅浸渍过的框架被卷曲成很小的外形并且扩张回较大的外形而不明显损坏硅层。此外，硅材料能够增加框架和人工瓣膜被植入其中的自体环之间 的摩擦，结果得到较好的固定并且防止/减少瓣膜周边泄漏。 
硅裙部可以通过各种手段安装在框架上，包括利用心轴。而且，可以希望以与布裙部或织物裙部组合的方式利用硅裙部。例如，可以希望将硅裙部放置在至少围绕框架一部分的布裙部或织物裙部的外面。 
可替换地或附加地，硅裙部也可以放置在框架里面并且连接于框架，以便在工作循环期间它为小叶提供改进的保护。可替换地，作为硅的替代，裙部可以用增大的和/或膨胀的材料，例如合成的或天然的水凝胶。增大的材料是一种横向扩张同时纵向拉伸的材料，这意味着这种材料具有负泊松比。如果框架用增大的材料覆盖，当瓣膜从其卷曲状态扩张时，它能够径向地扩张同时被圆周地拉伸。这种扩张能够改善瓣膜在自体瓣膜环处的配合，因而防止或减少瓣膜周边的泄漏。 
鉴于本实用新型的原理能够应用于其中的许多可能的实施例，应当认识到，举例说明的实施例仅仅是本实用新型优选的例子，并且不应当限制本实用新型的范围。而是本实用新型的范围由所附权利要求限定。因此请求保护的实用新型在这些权利要求的范围和精神内。 

Claims (17)

1.一种可植入的人工瓣膜，其特征在于包括：
径向可收缩的并且可扩张的环形框架，该框架具有三个接缝连接柱和在所述接缝连接柱之间延伸的至少三行圆周支杆，第一行圆周支杆限定所述框架的流入端，而与所述第一行间隔开的第二圆周支杆和第三行圆周支杆邻近所述框架的流出端，所述第一行通过多个轴向支杆连接于所述第二行和所述第三行；
包括由心包组织形成的三个小叶的小叶结构，每个小叶具有上边缘、弯曲的下边缘和两个侧面片状物，其中每个侧面片状物固定于另一个小叶的相邻的侧面片状物，以形成所述小叶结构的接缝，每个接缝连接于所述接缝连接柱中的一个；
设置在所述环形框架和所述小叶结构之间的环形的裙部部件，每个小叶的所述弯曲的下边缘沿着扇贝形路线缝合于所述裙部部件的内表面；以及
靠近所述小叶结构的弯曲下边缘固定于所述小叶结构的内表面的加强带，使得所述小叶被夹在所述环形裙部部件和所述加强带之间。
2.根据权利要求1所述的人工瓣膜，其特征在于每行圆周支杆包括成角度的支杆，该成角度的支杆布置成Z字形图形并且通过大致U形的隆起结构相互连接以便改进可收缩性。
3.根据权利要求2所述的人工瓣膜，其特征在于当所述环形框架处于扩张状态时所述成角度的支杆以大约90度和110度之间的角度A连接。
4.根据权利要求1所述的人工瓣膜，其特征在于所述第一行和所述第二行圆周支杆具有平行的Z字形图形。
5.根据权利要求4所述的人工瓣膜，其特征在于所述第三行圆周支杆的所述Z字形图形与所述第一行和所述第二行圆周支杆的Z字形图形相反。
6.根据权利要求1所述的人工瓣膜，其特征在于所述框架包括镍钴铬合金。
7.根据权利要求6所述的人工瓣膜，其特征在于所述镍钴铬合金包括MP35N。
8.根据权利要求1所述的人工瓣膜，其特征在于所述第一行的支杆比所述第二行和所述第三行的支杆厚。
9.根据权利要求1所述的人工瓣膜，其特征在于所述环形框架是可塑性扩张的。
10.根据权利要求1所述的人工瓣膜，其特征在于还包括密封所述框架的至少一部分的环形弹性层。
11.根据权利要求1所述的人工瓣膜，其特征在于所述加强带包括多个加强带，所述多个加强带中的每一个都靠近各小叶的下边缘固定于所述各小叶的内表面。
12.根据权利要求1所述的人工瓣膜，其特征在于所述加强带和所述裙部部件是由材料构成的分开的件。
13.根据权利要求12所述的人工瓣膜，其特征在于所述加强带和所述裙部部件其中每一个都由合成材料制成。
14.根据权利要求1所述的人工瓣膜，其特征在于还包括邻近每个接缝连接柱设置的成对加强杆，每个加强杆包括多个孔，其中每个侧面片状物围绕一个加强杆延伸，并且每个加强杆缝合于一个接缝连接柱，用于加强所述小叶结构和所述接缝连接柱之间的连接。
15.根据权利要求14所述的人工瓣膜，其特征在于所述小叶结构的所述接缝用延伸通过所述侧面片状物、所述加强杆和所述接缝连接柱的缝合线连接于所述接缝连接柱。
16.根据权利要求14所述的人工瓣膜，其特征在于每个加强杆被保护套筒覆盖。
17.根据权利要求14所述的人工瓣膜，其特征在于每个加强杆具有四个孔，这四个孔对应于形成在每个接缝连接柱中的四个孔。
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