CN108601656A - 具有多层次密封构件的假体心脏瓣膜 - Google Patents

具有多层次密封构件的假体心脏瓣膜 Download PDF

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CN108601656A
CN108601656A CN201780011106.3A CN201780011106A CN108601656A CN 108601656 A CN108601656 A CN 108601656A CN 201780011106 A CN201780011106 A CN 201780011106A CN 108601656 A CN108601656 A CN 108601656A
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frame
skirt
valve
edge
outer skirt
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H·柯赫恩-泽马奇
T·S·利维
N·尼尔
B·费尔森
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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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • 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
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0026—Angular shapes trapezoidal
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

公开了假体心脏瓣膜的实施方式。可植入假体瓣膜可径向皱缩至皱缩构型并可径向扩张至扩张构型。假体瓣膜可包括环形框架、定位在框架内的小叶结构以及定位在框架外表面周围的多个外裙部，每一个外裙部都包括固定至框架的流入边缘和以间隔固定至框架的流出边缘。多个外裙部可包括第一外裙部和第二外裙部，其中在扩张构型中第一和第二外裙部包括间隔之间、不固定至框架的开口。第一环形外裙部的流入边缘可用包含不透射线的材料的缝线固定至框架。第一环形外裙部可包含不透射线的染料。

Description

具有多层次密封构件的假体心脏瓣膜
技术领域
本公开涉及假体心脏瓣膜的实施方式。
背景技术
人心脏可遭受各种瓣膜疾病。这些瓣膜疾病可导致心脏的重大机能失常并最终需要用人工瓣膜置换天然瓣膜。存在多种已知的人工瓣膜和在人体中植入这些人工瓣膜的多种已知的方法。
各种手术技术可用于置换或修复患病的或损伤的瓣膜。由于狭窄和其它心脏瓣膜疾病，成千上万的患者每年经受手术，其中有缺陷的天然心脏瓣膜被假体瓣膜置换。另一种用于治疗有缺陷的瓣膜的不太激烈的方法是通过修复或重建，其一般用于最低限度钙化的瓣膜上。手术疗法的问题是其以与手术修复相关的高发病率和死亡率施加在这些长期患病患者上的显著风险。
在将天然瓣膜置换时，假体瓣膜的手术植入一般需要开胸手术，在手术期间心脏停止并且患者置于心肺分流术(所谓的“心-肺机”)。在一种常见手术程序中，将患病的天然瓣膜小叶切除并将假体瓣膜缝合至瓣膜环处的周围组织。由于与程序相关的创伤和伴随的体外血液循环的持续时间，一些患者无法在手术程序中存活或在其后短时间死亡。众所周知，对患者的风险随着体外循环所需的时间量增加。由于这些风险，具有有缺陷的天然瓣膜的大量患者被认为是不能动手术的，因为他们的情况太脆弱而不能经受该程序。通过某些估计，年过80岁、患有瓣膜狭窄的受试者中超过50％是不能进行瓣膜置换手术的。
由于与传统心脏直视手术有关的缺点，经皮的和微创手术方法正获得广泛关注。在一项技术中，假体瓣膜被配置以通过导管插入(catherterization)以较少创伤程序植入。例如，美国专利号5,411,522和6,730,118描述了可以以在导管上的压缩状态经皮导入并通过球囊膨胀或通过利用自扩张框架或支架在期望的定位中扩张的可皱缩经导管心脏瓣膜。
经导管心脏瓣膜的重要设计参数是心脏瓣膜的适当定位，例如在膨胀前定位在球囊上以及定位在植入位置，以便防止反向瓣膜的最终定位。进一步重要的设计参数是瓣周漏(PVL)的最小化。PVL可包括并发症诸如血液流动通过被植入的瓣膜结构和心脏组织之间的通道，例如由于缺乏适当的密封。
发明概述
假体心脏瓣膜的示例性实施方式可包括环形框架、定位在框架内的小叶结构、和定位在框架外表面周围的两个或更多个环形外裙部。两个或更多个外裙部每一个都可包括固定至框架的流入边缘以及流出边缘，其中两个或更多个外裙部中的流出边缘可限定一个或多个上开口，所述上开口允许框架外表面和两个或更多个裙部之间的逆行血流沿假体瓣膜产生多个湍流血流区域。
可植入假体瓣膜的一些实施方式可以可径向皱缩至皱缩构型并可径向扩张至扩张构型。假体瓣膜的一些实施方式可包括环形框架、定位在框架内的小叶结构、和定位在框架外表面周围的多个外裙部。每一个外裙部可包括固定至框架的流入边缘和以间隔固定至框架的流出边缘。多个外裙部可包括第一外裙部和第二外裙部，其中在扩张构型中，第一和第二外裙部可包括间隔之间、不固定至框架的开口。
在一些实施方式中，第一外裙部的流入边缘可用包括不透射线的材料的缝线固定至框架。在一些实施方式中，第一外裙部可包括由不透射线的染料形成的标记。
在一些实施方式中，第一外裙部和第二外裙部的开口可周向对齐。另外地和/或可选地，在一些实施方式中，开口可不平放抵靠框架的外表面并与处于扩张构型的框架径向向外间隔。另外地和/或可选地，第二外裙部的流入边缘可接触第一外裙部的流出边缘而在之间无任何轴向间距。多个外裙部中的至少一个的流出边缘可不固定至框架。多个外裙部可沿框架的流入边缘和框架的流出边缘之间的框架长度被串联定位。多个裙部中的至少两个的轴向高度可以是相同的。
假体心脏瓣膜的一些实施方式可包括具有流入端和流出端的环形框架、定位在框架内的小叶结构和安装在框架上的环形裙部。裙部可包括不透射线的标记——其可包括不透射线的缝线和不透射线的染料中的一者或两者——以促进假体瓣膜在X射线检查(fluoroscopy)下的定位。
本公开的前述和其它对象、特征、和优势将通过以下详细描述而变得更显而易见，其通过参照附图进行。
附图简述
图1显示了假体心脏瓣膜的示例性实施方式的透视图。
图2显示了图1假体心脏瓣膜的俯视图。
图3显示了图1假体心脏瓣膜的示例性框架的透视图。
图4显示了其中外裙部被移除以显示安装在框架上的内裙部和瓣膜结构的组件的图1假体心脏瓣膜的侧视图。
图5显示了平放的示例性外裙部。
图6是显示了在植入天然心脏瓣膜环中时血液在假体心脏瓣膜外流动的图1假体心脏瓣膜的示意图。
图7A是根据另一实施方式处于扩张构型的具有多个外裙部的假体瓣膜的侧视图。
图7B是处于皱缩构型的图7A假体瓣膜的侧视图。
图8是图7A假体瓣膜的流入端部分的放大视图。
图9显示了平放的裙部的另一实施方式。
图10显示了固定至图3框架的图9裙部。
发明内容
出于此描述的各目的，在此描述本公开的实施方式的某些方面、优势、和新颖特征。结合本公开的具体方面、实施方式或实例描述的特征、整数、特性、化合物、化学部分或基团将被理解为适用于本文描述的任何其它方面、实施方式或实例，除非与之不相容。本说明书(包括任何所附权利要求、摘要、和附图)中公开的所有特征、和/或因此公开的任何方法或过程的所有步骤，可以以任何组合进行组合，除了这种特征和/或步骤中至少一些相互排斥的组合之外。本公开不受限于任何前述实施方式的细节。本公开扩展到本说明书(包括任何所附权利要求、摘要、和附图)中公开的特征中的任何新颖的一个特征、或任何新颖的组合，或扩展到因此公开的任何方法或过程的步骤中的任何新颖的一个步骤、或任何新颖的组合。
尽管为了方便展示以具体的相继顺序描述了本公开方法中的一些的操作，但应当理解这种描述方式包括重排，除非以特定用语规定了具体顺序。例如，相继描述的操作可在一些情况下重排或同时进行。而且，为简要起见，附图可能未显示本公开的方法可与其它方法结合使用的各种方式。
本文中使用的术语“一种”、“一个”、和“至少一个(种)”包括一个或多个(一种或多种)所述要素。也就是说，如果存在两个特定要素，则这些要素中的其中一个也是存在的，因此“一个”要素是存在的。术语“多个”和“多种”意为两个或更多个(两种或更多种)所述要素。
如本文中所用，用在要素列举中的最后两个之间的术语“和/或”意为所列要素中的任意一个或多个。例如，短语“A、B、和/或C”意为“A”、“B”、“C”、“A和B”、“A和C”、“B和C”、或“A、B、和C。”
本文中使用的术语“耦接”总体上意为物理耦接或连接，并且在没有特别的相反语言时不排除耦接项之间存在中间元素。
图1和2分别显示了根据一个实施方式的假体心脏瓣膜10的透视图和俯视图。示例的假体瓣膜适于植入天然主动脉环中，虽然在其它实施方式中其可适于植入心脏的其它天然环(二尖瓣、肺动脉瓣和三尖瓣)中。假体瓣膜10可具有一个或多个以下的部件：支架或框架12、瓣膜结构14和/或内裙部、或密封构件16。瓣膜10还可包括两个或更多个外裙部、或密封构件。例如，瓣膜可包括第一外裙部或密封构件18、第二外裙部或密封构件20以及第三外裙部或密封构件22。
瓣膜结构14可包括三个小叶24，共同形成小叶结构，小叶结构可被布置成以三尖瓣布置皱缩，如图2中最佳所示。小叶结构14的下边缘期望地具有起伏的、弯曲的扇形形状。通过以这个扇形几何形成小叶，小叶上的压力减少，进而提高了瓣膜的耐久性。而且，凭借扇形形状，可消除或至少最小化每个小叶的腹部(每个小叶的中心区域)处的折叠和波纹，该折叠和波纹可引起那些区域早期钙化。扇形几何形状还减少形成小叶结构的组织材料用量，从而允许瓣膜的流入端处较小的、较平坦的折绉(crimped)轮廓。小叶24可由心包组织(例如，牛心包组织)、生物相容性合成材料、或本领域已知和美国专利号6,730,118(通过引用并入本文)中描述的各种其它合适的天然或合成材料形成。美国公开号2012/0123529中公开了有关小叶的结构和用于将小叶24安装至框架和内裙部的进一步细节。
裸框架12显示在图3中。框架12具有流入端40和流出端42。在示例的实施方式中框架12包括多个成角支柱44，其以沿框架长度的多个周向的成排支柱被布置。一对或多对相邻排的成角支柱44可通过垂直支柱46连接。接近框架12的流出端的成排支柱44还可以以多个(例如，三个)周向隔开的连合支撑物48和垂直支柱46相互连接。连合支撑物48可形成具有各自的槽或连合窗口50，其适于将瓣膜结构14的连合安装至框架，如下文更详细地描述。
框架12可由本领域已知的各种适合的可塑性扩张材料(例如，不锈钢等)或自扩张材料(例如，镍钛诺)中的任意一种制成。可选地，框架可被机械扩张。当由可塑性扩张材料构成时，框架12(以及因此，假体瓣膜10)可在递送导管上折绉到径向压缩状态，然后通过可膨胀球囊或等同的扩张机构在患者内扩张。当由可自扩张材料构成时，框架12(以及因此，假体瓣膜10)可折绉到径向压缩状态，并通过插入递送导管的鞘或等同机构中被限制在压缩状态中。在处于身体内后，瓣膜可从递送鞘被推出，这允许瓣膜扩张到其功能尺寸。
可用于形成框架12的适当可塑性扩张材料非限制地包括，不锈钢、镍基合金(例如，钴-铬或镍-钴-铬合金)、聚合物或其组合。在具体的实施方式中，框架12由镍-钴-铬-钼合金制成，如MP35NTM(SPS Technologies的商标名)，其等同于UNS R30035(被ASTM F562-02覆盖)。MP35NTM/UNS R30035包含按重量计35％镍、35％钴、20％铬、和10％钼。已发现利用MP35N形成框架12提供了优于不锈钢的结构效果。具体地，当MP35N用作框架材料时，在径向和挤压力耐性、疲劳耐性、和腐蚀耐性方面需要较少的材料达到相同或更好的性能。而且，由于需要较少的材料，可以减少框架的折绉轮廓，从而提供较低轮廓的瓣膜组件以经皮递送到身体中的治疗位置。
在其它实施方式中，框架12可具有其它构型或形状。例如，框架12可包括多个周向成排的成角支柱44，该成角支柱直接相互连接而无相邻排的支柱44之间的垂直支柱46或连合支撑物48，或成排支柱44可均等地以垂直支柱46和/或连合支撑物48间隔。在其它实施方式中，框架可包含编织金属。
内裙部16可具有多个功能，其可包括协助瓣膜结构14和/或外裙部固定至框架12并通过阻止血流通过小叶的下边缘下方的框架12的开放室来协助在瓣膜与天然环之间形成良好密封。内裙部16可包括坚韧、抗撕裂材料如聚对苯二甲酸乙二酯(PET)，虽然可以使用各种其它合成或天然材料。裙部厚度期望地小于6密尔，并期望地小于4密尔，以及甚至更期望地为约2密尔。在具体实施方式中，裙部16可具有可变厚度，例如，裙部在其边缘比在其中心更厚。在一个实施方案中，裙部16可包括在其边缘约0.07mm和在其中心约0.06mm的厚度的PET裙部。较薄的裙部可提供更好的折绉性能同时还提供良好的瓣周密封性。
图4显示了在将小叶结构固定至内裙部至框架然后将这些部件固定至框架之后的框架12、小叶结构14和内裙部16。内裙部16可通过缝线26被固定至框架12的内部。瓣膜结构14可通过沿小叶的下(流入)边缘的一个或多个薄PET增强条带(未显示)附接至内裙部。增强条带可共同形成套筒，其能够使缝合牢固并防止小叶结构的心包组织撕裂。瓣膜结构14可被夹在内裙部16与薄PET条带之间。将PET条带和小叶结构14固定至内裙部16的缝线28可为任意适合的缝线，如Ethibond缝线。缝线28所期望地追随小叶结构14的下边缘的曲度。瓣膜结构14的流出端部分可被固定至连合支撑物48。具体地，每一个小叶24都可具有相对的接头(tab)部分，每一个相对的接头部分都与另一小叶的相邻接头部分配对以形成连合54。如图4中最佳所示，连合54可延伸通过各自的连合支撑物48的窗口50并被缝合在适当位置。
在图4中，内裙部16矮于连合支撑物48终止并且不延伸框架12的整个长度。在可选实施方式中，内裙部16可从流入端40至流出端42延伸框架12的整个长度或基本上整个长度。使内裙部16延伸框架12的整个长度对用于在沿框架长度的任意位置将外裙部固定至框架可以是有利的。
已知的织物裙部包括彼此垂直延伸的经线纤维和纬线纤维与垂直于裙部的上边缘和下边缘延伸的一组纤维的编织物。固定有织物裙部的金属框架被径向压缩时，框架的整体轴向长度增加。不幸地，固有地具有有限弹性的织物裙部不能与框架一起伸长，因此趋于使框架的支柱变形并阻止均匀折绉。
内裙部可由第一组纤维或纱线或线股(strands)和第二组纤维或纱线或线股编织，二者均不与裙部的上边缘和下边缘垂直。在具体实施方式中，第一组纤维和第二组纤维相对于上边缘和下边缘以约45度的角度延伸。内裙部16可通过相对于织物的上边缘和下边缘以45度角编织纤维而形成。可选地，裙部可由竖直编织的织物(其中纤维垂直于材料边缘延伸)沿对角线切割，使得纤维相对于裙部的切割上边缘和下边缘以45度角延伸。内裙部的相对的短边缘所期望地与上边缘和下边缘是不垂直的。例如，短边缘所期望地相对于上边缘和下边缘以约45度的角度延伸，并因此与第一组纤维对齐。因此内裙部的整体形状可以是偏菱形(rhomboid)的整体形状。
如图1中所示，瓣膜10可包括安装在框架12外的两个或更多个外裙部。两个或更多个外裙部可被组装在瓣膜10的外径上并可定位在沿框架长度的不同层次(level)或位置。例如，如图1中所示，瓣膜10可包括第一外裙部18、第二外裙部20和第三外裙部22。一个或多个第一、第二和第三外裙部18、20、22可被缝合至内裙部。另外地和/或可选地，一个或多个第一、第二和第三外裙部18、20、22可被缝合至框架。在被安装在框架12上时每一个外裙部所期望地包括管形或圆柱形形状以便在框架的外表面周围完全延伸。
图5显示了在其附接至框架12和/或内裙部16之前外裙部18、20、22中的一个的展平视图。外裙部18、20、22可由强力、耐用的材料件(piece)如编织的PET激光切割或以其它方式形成，虽然可以使用其它合成或天然材料。外裙部18、20、22可具有基本上笔直的下边缘30和上边缘32——限定了多个交替突起34和凹口36。尽管示例的实施方式包括三个这样的外裙部，但是在可选实施方式中假体瓣膜可具有两个外裙部或大于三个外裙部(例如，四个、五个、或六个外裙部)。每一个外裙部18、20、22可具有相同的(从下边缘30至上边缘测量的)高度。在可选实施方式中，外裙部的高度可从一个外裙部变化至下一个。
如图1中最佳所示，第一外裙部18的下边缘30可在假体瓣膜的流入端被缝合至内裙部16的下边缘和/或框架的支柱44的第一横档(rung)。第二外裙部20的下边缘30可在第一外裙部18的上边缘32下游且相邻第一外裙部18的上边缘32被缝合至内裙部16和/或框架12的支柱44。第三外裙部22的下边缘30可在第二外裙部20的上边缘32下游且相邻第二外裙部20的上边缘32被缝合至内裙部16和/或框架12的支柱44。在具体实施方式中，外裙部18、20、22的下边缘30被紧密缝合或以其它方式(例如，通过焊接或粘合剂)被固定至内裙部16以捕获框架与外裙部之间流动的逆行血液，如下文进一步描述。
外裙部18、20、22可沿框架12的长度在轴向上彼此略微间隔使得一个外裙部的下边缘与相邻外裙部的上边缘之间存在一些间距。在可选实施方式中，外裙部18、20、22可相对于彼此被定位，其中每一个外裙部的下边缘30接触相邻外裙部的上边缘32(除了在框架的流入端)，而在相邻外裙部之间无任何轴向间距。在其它实施方式中，相邻外裙部之间的轴向间距可沿框架长度变化。另外，(从下边缘30至上边缘32测量的)外裙部的高度可从一个裙部变化至下一个。
外裙部的上边缘32所期望地在框架的周长周围间隔开的位置被固定至框架12和/或内裙部16以形成可接收逆行血流的多个开口38。在示例的实施方式中，例如，可将外裙部的突起34缝合至框架12的支柱44和/或内裙部16。如所示，第一外裙部18和第二外裙部20的突起34的转角可折叠在各自的支柱44上方并用缝线52固定。第三外裙部22的突起34可如所示被固定至内裙部16或在框架的流出端42被固定至支柱44。
凹口36在假体瓣膜径向扩张期间可保持不附接至内裙部16和框架12以形成开口38，如下文中进一步详细解释。外裙部18、20、22可附接至内裙部和/或框架，使得外裙部18、20、22的凹口36和开口38沿瓣膜的长度对齐(如图1中所示)。可选地，一个外裙部的凹口36和开口38可从另一外裙部的凹口和开口有角度地或周向偏移。例如，第一外裙部18的开口38可从第二和第三外裙部18、20、22中的一者或两者的开口38周向偏移，并且第二外裙部20的开口38可从第一外裙部18和第三外裙部22中的一者或两者的开口38周向偏移。
外裙部18、20、22中的每一个都可被固定至框架12使得在框架处于扩张状态时，在裙部的下边缘30和上边缘32之间存在不平放抵靠框架12的外表面的多余材料或松弛(slack)。换言之，外裙部18、20、22可包括多余材料，其导致在径向扩张期间随着框架缩短(即，长度变短)裙部向外鼓起(billow)。
在将瓣膜10部署在身体内(例如，在天然主动脉瓣内)时，外裙部18、20、22可与内裙部16协作以防止或至少最小化瓣周漏。在另一有利特征中，两个或更多个外裙部的下边缘和上边缘之间的松弛允许框架12在折绉期间轴向伸长而无来自外裙部的任何抵抗。
外裙部18、20、22可显著降低瓣周漏(PVL)的风险——由于多种机制。PVL包括由于假体瓣膜和周围组织之间缺乏适当密封而血液流动通过植入瓣膜的结构和心脏组织之间的通道。公开的瓣膜可通过本质上具有动力性的装置(例如裙部的鼓起)减少PVL，以及其它的可基于凭借湍流有意阻碍流动的元件。公开的假体瓣膜10如何能减少PVL的实例包括对流动的物理阻碍。换言之，外裙部可延伸至框架12和周围的天然环之间的间隙中并填充该间隙以协助在瓣膜和天然环之间形成良好的流体紧密密封。另外地和/或可选地，由于沿裙部的上边缘的开口，逆行血液可流动至开口中并以上升的回压(例如，当在主动脉位置植入时的舒张压)进一步使外裙部打开或径向扩张——类似于扬帆的动作——以增强裙部抵靠周围组织的密封。
另外地和/或可选地，长期来看，还可能有发生的生物级联反应——减少PVL。具体地，纤维蛋白沉积可最初密封用于外裙部的织物材料的孔，其可导致血液凝固和长远来看，由纤维变性组织对外裙部的置换。
另外地和/或可选地，外裙部可通过其减少PVL的另一机制为裙部开口38产生的湍流。进一步解释，图6显示了部署在身体内的假体瓣膜10(例如，天然主动脉瓣膜)。箭头70表示(例如，对于主动脉定位收缩期)流动通过假体瓣膜10的顺行血流以及箭头72表示(例如，对于主动脉定位舒张期)以相对方向在假体瓣膜外侧流动的逆行血流。逆行血液可流动至开口38中，其在外裙部18、20、22中的每一个处产生湍流血流区域，如箭头74表示。湍流74干扰总体上分层的逆流72，从而减少通过大于外裙部外径的腔的渗漏或回流。换言之，多个外裙部可引起沿渗漏路径的串联的湍流阻碍，其中沿假体瓣膜长度的每一个开口至少部分地中断并减少逆流。因此，在置于串联时，开口可产生沿假体瓣膜长度的充足的湍流以阻止或至少最小化PVL。以此方式，密封元件可以以类似于忒斯拉瓣膜导管(Tesla’s ValvularConduit)的方式在功能上起作用。而且，裙部提供的沿假体瓣膜长度的多个阻碍可用天然组织促进凝固和生物密封。
具有置于串联的多个外裙部的假体瓣膜可利用限定在假体瓣膜外侧与周围相邻解剖结构之间的潜在渗漏通道的潜在高的长度与直径的比率。在较高比率下，可实施较多这种阻碍，从而产生更好的密封。以从入口至出口的方向移动假体瓣膜，假体瓣膜的植入区域可在左心室流出道(LVOT)起始并在天然小叶的自由边缘终止。如果假体瓣膜沿这个整个界面延伸，那么潜在渗漏通道的长度可被最大化。例如，假体瓣膜可相邻LVOT延伸约2-4mm并且相邻主动脉环和天然小叶延伸约10-16mm。因此，在此实例中，解剖密封区域大致可为12-20mm。
两个或更多个裙部中的裙部数目是可变的并且可取决于瓣膜设计和取决于渗漏阻碍优化。另外地和/或可选地，两个或更多个裙部沿瓣膜高度的位置以及每一个裙部的高度可根据具体应用而变化。
图7A、7B和8显示了假体瓣膜的另一实施方式，总体上以100表示。假体瓣膜100可包括支架或框架102、沿框架长度串联定位的多个外裙部104、106、108、和瓣膜结构(未显示在图7和8中但可为瓣膜结构14)。假体瓣膜100还可包括内裙部，如内裙部16。每一个外裙部都可包括固定至框架102外侧的下边缘110以及上边缘112。
外裙部104、106、108与外裙部18、20、22的区别在于不需要将外裙部104、106、108沿其上边缘112连接至框架102。因此，在将假体瓣膜部署以形成围绕框架延伸360度的连续上开口时，每一个外裙部的整个上边缘112可与框架102的外表面径向向外间隔。
图7B显示了递送导管上处于用于递送至患者身体中的径向压缩状态的假体瓣膜100。在递送构型中，外裙部104、106、108可折叠抵靠框架102的外表面。当部署在身体内时(例如，在从递送导管的鞘被释放后)，支架102可径向扩张并且外裙部可枢轴转动远离框架的外表面，如图7A中所描绘。在从鞘部署时，可由PET织物或另一适合材料形成的外裙部可被设置形状以枢轴转动远离框架。
代替将裙部材料设置形状或除了将裙部材料设置形状外，外裙部可包括在裙部的下边缘110以枢轴转动方式连接至框架的多个支柱114(如图8中所示)。支柱114可由形状记忆金属(例如，镍钛诺)形成，该支柱被配置以在从鞘部署假体瓣膜时从框架向外枢轴转动以偏置裙部至其部署状态。可选地，外裙部可包括编织织物，该编织织物包含以轴向方向(从下边缘110至上边缘112)延伸、使裙部偏置至其部署状态的相对更刚性的纤维或长丝或金属丝(例如，镍钛诺丝)。
在一些实施方式中，假体瓣膜的外裙部中的一个或多个可包括从假体瓣膜的框架突起的多个开口。每一个开口的高度和角度都可被优化以最大化流动阻碍。另外地和/或可选地，外裙部中的一个或多个可包括裙部材料的上边缘处的边(fringes)以进一步干扰渗漏流。另外地和/或可选地，可增加外裙部的表面(内表面和/或外表面)的粗糙度以促进逆行血液的流动干扰，从而增强裙部的密封效果。可通过由包含绒头(割绒(cut pile)或毛圈绒(loop pile))的织物或纺织物——类似于毛巾或地毯的编织物——形成裙部来增加表面粗糙度。
用于形成假体瓣膜的柔软部件如瓣膜结构的裙部和小叶的材料一般在X射线检查下是不可见的。因此，在部署前医师可能很难确定假体瓣膜以正确方向——其中假体瓣膜的流入端定位在假体瓣膜的流出端上游——被定向。如果假体瓣膜的框架具有轴对称形状(框架相对于垂直于框架长度的平面是对称的)使得可能难以在X射线检查下辨别框架的定向，那么这可能是尤其有问题的。
在具体实施方式中，假体瓣膜可具有裙部(其可为外裙部或内裙部)，该裙部具有不透射线的标记以协助相对于所期望的植入位点进行适当定位。图9显示了裙部200，该裙部具有以分别，例如，竖直和/或水平线202、204形式的不透射线的标记。裙部上不透射线的标记还可包括各种其它形状，如对角线、箭头、圆等。
可使用不透射线的染料将线202、204印刷在裙部织物上。另外地和/或可选地，可使用不透射线的缝线或线(threads)将线202、204形成在裙部织物上。染料和/或缝线两者都可包含一种或多种不透射线的材料，如铂、铂-铱、金和/或其它金属。不透射线的缝线可包括，例如，沿缝线长度涂有不透射线的材料或具有不透射线的标记的常规缝线(例如，6/0缝线)。由于标记在X射线检查下是可见的，因此医师能够利用标记确定假体瓣膜以正确定向被安装在递送设备上，从而防止反向部署瓣膜并使假体瓣膜相对于所期望的植入位点定位。
图10显示了类似于图1中所示的假体瓣膜的假体瓣膜，但具有安装至框架外侧的裙部200。代替裙部200上不透射线的标记或除裙部200上不透射线的标记外，不透射线的缝线206可用于将裙部的下边缘和/或上边缘固定至框架12。不透射线的缝线206可在瓣膜部署期间用于确定假体瓣膜的正确定向并用于促进裙部适当轴向定位在钙化环内。另外地和/或可选地，可将不透射线的缝线直接缠绕在所选框架支柱周围或以其它方式将不透射线的缝线固定至所选框架支柱，例如，框架的流入端和/或流出端处的支柱或裙部的下边缘和/或上边缘处的支柱。
鉴于本公开技术的原理可适用的多种可能的实施方式，应认识到示例的实施方式仅仅是本公开的优选实例，不应被用作限制本公开的范围。因而本公开的范围由所附权利要求来限定。因此，我们要求所有属于这些权利要求的范围和精神的都是我们的发明。

Claims (20)

1.可植入假体瓣膜，其包括：
环形框架；
小叶结构，所述小叶结构定位在所述框架内；和
两个或更多个环形外裙部，所述环形外裙部定位在所述框架的外表面周围，所述两个或更多个外裙部每一个都包括固定至所述框架的流入边缘以及流出边缘，其中所述两个或更多个外裙部的流出边缘限定一个或多个上开口，所述上开口允许逆行血液在所述框架的外表面和所述两个或更多个裙部之间流动从而沿所述假体瓣膜产生多个湍流血流区域。
2.权利要求1所述的瓣膜，其中所述两个或更多个外裙部中的至少一个的流入边缘用包含不透射线的材料的缝线固定至所述框架。
3.权利要求1-2中任一项所述的瓣膜，其中所述两个或更多个外裙部中的至少一个包含由不透射线的染料形成的标记。
4.权利要求1-3中任一项所述的瓣膜，其中所述两个或更多个外裙部中的至少两个的流出边缘以间隔被固定至所述框架并包括不固定至所述框架的所述间隔之间的开口。
5.权利要求1-4中任一项所述的瓣膜，其中所述一个或多个开口不平放抵靠处于扩张构型的所述框架的外表面。
6.权利要求1-5中任一项所述的瓣膜，其中所述两个或更多个外裙部中的至少一个的流出边缘不固定至所述框架。
7.权利要求1-6中任一项所述的瓣膜，其中所述两个或更多个外裙部之间的轴向间距小于所述两个或更多个外裙部中的至少一个的轴向高度。
8.权利要求1-7中任一项所述的瓣膜，其中所述两个或更多个外裙部在所述框架的流入边缘和所述框架的流出边缘之间沿所述框架的长度被串联定位。
9.权利要求1-8中任一项所述的瓣膜，其中所述两个或更多个外裙部中的至少一个的流入边缘接触所述两个或更多个外裙部中的另一个的流出边缘而在之间无任何轴向间距。
10.可植入假体瓣膜，所述可植入假体瓣膜可径向皱缩至皱缩构型并可径向扩张至扩张构型，所述假体瓣膜包括：
环形框架；
小叶结构，所述小叶结构定位在所述框架内；和
多个外裙部，所述多个外裙部定位在所述框架的外表面周围，每一个外裙部都包括固定至所述框架的流入边缘和以间隔固定至所述框架的流出边缘，所述多个外裙部包括第一外裙部和第二外裙部，其中在所述扩张构型中，所述第一和第二外裙部包括所述间隔之间、不固定至所述框架的开口。
11.权利要求10所述的瓣膜，其中所述第一外裙部包含由不透射线的染料形成的标记。
12.权利要求10-11中任一项所述的瓣膜，其中所述多个外裙部进一步包括第三外裙部，其中在所述扩张构型中，所述第三外裙部包括在所述间隔之间、不固定至所述框架的开口。
13.权利要求10-12中任一项所述的瓣膜，其中所述第一外裙部和所述第二外裙部的开口周向对齐。
14.权利要求10-13中任一项所述的瓣膜，其中所述开口不平放抵靠处于所述扩张构型的所述框架的外表面。
15.权利要求10-14中任一项所述的瓣膜，其中所述第二外裙部的流入边缘接触所述第一外裙部的流出边缘而在之间无任何轴向间距。
16.权利要求10-15中任一项所述的瓣膜，其中所述多个外裙部中的至少一个的流出边缘不固定至所述框架。
17.权利要求10-16中任一项所述的瓣膜，其中所述多个外裙部在所述框架的流入边缘和所述框架的流出边缘之间沿所述框架的长度被串联定位。
18.权利要求10-17中任一项所述的瓣膜，其中所述多个裙部中的至少两个的轴向高度是相同的。
19.可植入假体瓣膜，其包括：
环形框架，所述环形框架具有流入端和流出端；
小叶结构，所述小叶结构定位在所述框架内；和
环形裙部，所述环形裙部安装在所述框架上，所述裙部包含不透射线的标记。
20.权利要求19所述的瓣膜，其中不透射线的标记包括不透射线的缝线和不透射线的染料中的一者或两者。
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