CN113543750A - 用于正交经导管心脏瓣膜假体的三尖瓣反流控制装置 - Google Patents

用于正交经导管心脏瓣膜假体的三尖瓣反流控制装置 Download PDF

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CN113543750A
CN113543750A CN202080018634.3A CN202080018634A CN113543750A CN 113543750 A CN113543750 A CN 113543750A CN 202080018634 A CN202080018634 A CN 202080018634A CN 113543750 A CN113543750 A CN 113543750A
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valve
frame
control member
support frame
axis
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R·维德伦德
M·克里斯蒂安松
N·赛克里希南
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Vidine Co ltd
Vdyne LLC
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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
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    • A61F2/2421—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 non-pivoting rigid closure members
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Abstract

本发明涉及一种用于在经导管心脏瓣膜置换物，并且具体地正交递送的经导管人工心脏瓣膜内管理和提供有意反流水平的通路和封堵器装置，并且具体地心脏瓣膜反流鼓和任选的闭合碟和/或管状支架，所述正交递送的经导管人工心脏瓣膜具有第一内流量控制部件/瓣膜、第二内反流控制部件和具有可压缩线单元的外环形支撑框架，所述可压缩线单元有利于沿着z轴平折以及沿着y轴竖直地或与所述流量控制部件的中心轴线正交地压缩所述瓣膜，从而允许将非常大直径瓣膜从下腔静脉或上腔静脉递送和部署到三尖瓣膜，或者经心房递送和部署到二尖瓣膜，所述瓣膜具有约5‑60mm的高度和约25‑80mm的直径，而无需超大直径导管并且无需以锐角接近角从导管递送和部署。

Description

用于正交经导管心脏瓣膜假体的三尖瓣反流控制装置
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发明背景
技术领域
本发明涉及一种通路和封堵器装置，并且具体地涉及一种用于在经导管心脏瓣膜置换物(A61F2/2412)内管理和提供有意反流水平的心脏瓣膜反流鼓和任选的闭合碟和/或管状支架。
背景技术
1952年，外科医生植入第一个机械心脏瓣膜，其是仅可放置在降主动脉中而不是心脏自身中的球瓣膜。出于这个原因，它并未完全校正瓣膜问题，只是缓解了症状。然而，这是一项重大成就，因为它证明合成材料可用于产生心脏瓣膜。
1960年，发明了新型瓣膜并将其成功地植入。这种瓣膜就是Starr-Edwards球瓣膜，其以其创始人的名字命名。这种瓣膜是对Hufnagel的原始瓣膜的改良。瓣膜的球稍微更小并且从两侧笼罩，因此它可插入到心脏自身中。
下一次发展是20世纪60年代后期引入的倾斜式碟技术。这些瓣膜是对球设计的重大改进。倾斜式铸模技术允许血液以更加自然的方式流动，同时减少机械力对血细胞的损害。然而，随着时间的推移，这些瓣膜的支柱趋于因疲劳而断裂。截至2003年，已植入多于100,000个Omniscience和300,000个Hall-Kaster/Medtronic-Hall倾斜式碟瓣膜，基本上没有出现机械故障。
1977年，St.Jude引入了双小叶心脏瓣膜。类似于天然心脏瓣膜，血液直接流动通过安装在镍钛外壳内的热解碳瓣膜环的中心，这使得这些瓣膜优于其他设计。然而，这种设计的缺点在于它允许一定的反流。现今使用的绝大多数机械心脏瓣膜具有这种设计。截至2003年，部署了多于130万个St.Jude瓣膜和多于500,000个Carbomedics瓣膜，小叶或外壳均未出现故障。应注意，人类心脏每年跳动大约3100万次。
经由导管递送，而无需开放式心脏外科手术的创伤和并发症的可压缩瓣膜的发展继续进行。这意味着接受过内窥镜检查训练的心脏病专家理论上可在门诊规程期间部署心脏瓣膜置换物。然而，经导管瓣膜通常通过对心尖进行穿孔以进入心室来递送，并且穿孔通常用于锚定环形瓣膜置换物。
另外，支架式置换瓣膜的问题在于，它们通常继续存在前几代瓣膜的反流或泄漏问题，以及需要昂贵材料工程以便应对短短几年的正常心脏功能期间所遇到的数以百万计的循环。因此，仍然需要替代和更简单的解决方案来解决瓣膜相关的心脏疾病。
发明内容
本发明涉及一种通路和封堵器装置，并且具体地涉及一种用于在经导管心脏瓣膜置换物内、并且具体地在正交(纵向，沿着z轴)递送的经导管人工心脏瓣膜内管理和提供有意反流水平的心脏瓣膜反流鼓和任选的闭合部件和/或穿孔管状支架。
在优选实施方案中，一种用于正交递送的经导管人工心脏瓣膜的心脏瓣膜反流鼓以及任选的闭合部件和/或管状支架包括：第一内流量控制部件/瓣膜、第二内反流控制部件和具有可压缩线单元的外环形支撑框架，所述可压缩线单元有利于沿着z轴平折以及沿着y轴竖直地或与所述流量控制部件的中心轴线正交地压缩所述瓣膜，从而允许将非常大直径瓣膜从下腔静脉或上腔静脉递送和部署到三尖瓣膜，或者经中隔(经心房，横穿卵圆窝或邻近组织)递送和部署到二尖瓣膜，所述瓣膜具有约5-60mm的高度和约25-80mm的直径，而无需超大直径导管并且无需以锐角接近角从导管递送和部署。
在另一优选实施方案中，本发明提供用于在正交递送的经导管人工心脏瓣膜内管理和提供有意反流等级的装置，其包括：正交递送的经导管人工心脏瓣膜，所述正交递送的经导管人工心脏瓣膜具有(i)第一内流量控制部件(ii)第二内反流控制部件和(iii)外环形支撑框架，所述第二内反流控制部件具有可折叠且可压缩框架、附接到所述框架的组织覆盖件以及安装在加强环内的流量调节器，所述加强环安装在所述组织覆盖件上，所述流量调节器选自封堵器、管状支架以及在其管腔内具有封堵器的管状支架，所述组织覆盖件具有一个或多个不透射线标记物，并且所述第二内反流控制部件安装在所述人工心脏瓣膜的所述外支撑框架内，所述自扩张环形外支撑框架具有中心通道、在扩张构型中外接中心竖直轴线的外周边壁、沿着所述周边壁的顶部边缘安装的心房套环、安装在所述外环形支撑框架的远端侧上的远端锚定突片以及安装在所述外环形支撑框架的近端侧上的近端锚定突片，所述第一内流量控制部件在所述外环形支撑框架内邻近于所述第二内反流控制部件安装，所述第一内流量控制部件被构造来允许沿第一方向通过所述瓣膜的流入端部的血流并且阻止沿与所述第一方向相反的第二方向通过所述瓣膜的流出端部的血流，所述第一内流量控制部件具有小叶框架，所述小叶框架上安装有2-4个柔性小叶，其中所述第二内反流控制部件的所述可折叠且可压缩框架、所述第一内流量控制部件的所述小叶框架和所述外支撑框架中的每一者各自能够沿着水平z轴从圆柱形构型折叠为扁平圆柱体构型并且能够沿着竖直y轴压缩为缩短构型，其中所述人工心脏瓣膜能够压缩为压缩构型以用于使用递送导管引入到体内以便植入在所述体内的期望位置处，所述压缩构型沿着基本上平行于所述递送导管的纵向圆柱轴线的水平x轴取向，所述水平x轴取向成与所述中心竖直y轴成介于45-135度之间的相交角，并且所述压缩构型能够扩张为使所述水平x轴与所述中心竖直y轴成介于45-135度之间的相交角的扩张构型，其中所述瓣膜具有约5-60mm的高度和约25-80mm的直径。
在另一优选实施方案中，本发明提供一种瓣膜，其中所述环形外支撑框架具有内表面和外表面，所述内表面和所述外表面覆盖有生物相容性材料，选自由以下组成的项：所述内表面覆盖有心包组织，所述外表面覆盖有织造合成聚酯材料，以及所述内表面覆盖有心包组织和所述外表面覆盖有织造合成聚酯材料两者。
在另一优选实施方案中，本发明提供一种瓣膜，其中所述远端锚定突片、所述近端锚定突片或两者由线圈、线框架、激光切割框架、整合式框架部段或支架组成，并且背离所述环形外支撑框架的侧面延伸约10-40mm。
在另一优选实施方案中，本发明提供一种瓣膜，其还包括：上部远端锚定突片，所述上部远端锚定突片附接到所述环形支撑框架的远端上部边缘，所述上部远端锚定突片由线圈、线框架、激光切割框架、整合式框架部段或支架组成，并且背离所述环形外支撑框架延伸约2-20mm。
在另一优选实施方案中，本发明提供一种瓣膜，其包括：至少一个组织锚定件，所述至少一个组织锚定件连接到所述环形外支撑框架以用于接合天然组织。
在另一优选实施方案中，本发明提供一种瓣膜，其中所述环形外支撑框架由可压缩线单元组成，所述可压缩线单元选自由以下组成的组：编织线单元、激光切割线单元、光刻产生的线单元、3D打印线单元、由呈波浪形状、之字形状或螺旋形状的间歇地连接的单股线形成的线单元或它们的组合。
在另一优选实施方案中，本发明提供一种瓣膜，其中所述环形外支撑框架在外表面上覆盖有心包组织、聚酯材料或类似的生物相容性材料。
在另一优选实施方案中，本发明提供一种在植入式经导管人工心脏瓣膜中提供有意反流的方法，其包括以下步骤：通过将导管切割工具部署到如权利要求1所述的植入式瓣膜来对如权利要求1所述的第二内反流控制部件的所述加强环内的所述组织覆盖件的部段进行切割或穿孔以形成孔口，其中如权利要求1所述的瓣膜作为人工心脏瓣膜植入患者体内。
在另一优选实施方案中，本发明提供一种方法，其包括另外的步骤：将流量调节器部署到所述孔口中，所述流量调节器选自封堵器、管状支架以及在其管腔内具有封堵器的管状支架。
在另一优选实施方案中，本发明提供一种控制或调节具有正交递送的经导管人工心脏瓣膜的患者体内的反流的方法，其包括以下步骤：
步骤1.提供根据权利要求1所述的可折叠、可压缩人工三尖瓣膜；步骤2.将所述瓣膜侧向地装载到递送导管中；
步骤3.将所述瓣膜在螺纹连接到子环形远端突片上的预置引导线之上经由下腔静脉(IVC)或上腔静脉(SVC)推进到所述患者的心脏的三尖瓣膜；
步骤4.部分地排出所述瓣膜以定位所述远端子环形突片并且允许瓣膜小叶开始起作用；
步骤5.完成所述瓣膜到所述天然环中的部署；以及
步骤6.将切割工具或球囊工具通过所述递送导管推进到所部署瓣膜并且在所述内反流控制部件的所述组织覆盖物中产生1-5mm开口。
在另一优选实施方案中，本发明提供一种控制或调节反流的方法，其还包括：
步骤7.将起搏器线组推进通过所述内反流控制部件的所述组织覆盖物中的所述开口并且将一根或多根起搏器线附接在目标传导节点处或附近。
附图说明
图1是根据本发明的作为正交可递送经导管心脏瓣膜的一部分的具有不透射线标记物的内反流控制部件的侧透视图的图示，所述正交可递送经导管心脏瓣膜具有安装在环形外支撑框架内的可塌缩流量控制部件，可塌缩(内)流量控制部件具有小叶框架，小叶框架上安装有2-4个柔性小叶，小叶框架可沿着z轴从圆柱形构型折叠为扁平圆柱体构型并可沿着竖直轴线(y轴)压缩为缩短构型，并且瓣膜具有超弹性线圈远端突片和超弹性线圈近端突片。
图2是根据本发明的具有内反流控制部件的实施方案的侧透视分解图的图示，所述内反流控制部件具有不透射线标记物、三个小叶尖瓣或囊袋，所述三个小叶尖瓣或囊袋安装在可折叠且可压缩内线框架内，所述内线框架安装在外线框架内，所述外线框架具有周向地附接在外线框架的顶部边缘处的套环部件、双突片部件和网格部件。
图3是根据本发明的作为可正交可递送经导管心脏瓣膜的一部分的具有不透射线标记物的内反流控制部件的侧透视图的图示，所述正交可递送经导管心脏瓣膜具有安装在环形外支撑框架内的可塌缩流量控制部件，可塌缩(内)流量控制部件具有小叶框架，小叶框架上安装有2-4个柔性小叶，小叶框架可沿着z轴从圆柱形构型折叠为扁平圆柱体构型并且可沿着竖直轴线(y轴)压缩为缩短构型，并且瓣膜具有超弹性线圈远端突片和超弹性线圈近端突片。
图4是根据本发明的具有内反流控制部件的实施方案的侧透视分解图的图示，所述内反流控制部件具有不透射线标记物、三个小叶尖瓣或囊袋，所述三个小叶尖瓣或囊袋安装在可折叠且可压缩内线框架内，内线框架安装在外线框架内，外线框架具有周向地附接在外线框架的顶部边缘处的套环部件、一对整合式独立突片部件和网格部件。
图5是根据本发明的(当从较宽侧观察时从前向后)沿着z轴处于折叠构型的正交可递送经导管心脏瓣膜的侧透视图的图示。
图6是根据本发明的处于竖直地压缩构型的正交可递送经导管心脏瓣膜的侧透视图的图示。
图7是根据本发明的部分地装载到递送导管中的正交可递送经导管心脏瓣膜的侧透视图的图示。
图8是根据本发明的示出所装载瓣膜的递送导管的端视图的图示。
图9是在安置在天然环中之前从递送导管排出从而处于部分位置的折叠的压缩瓣膜的顶视图的图示，所述部分位置允许小叶和内框架扩张。
图10是根据本发明的瓣膜的顶部透视图的图示，所述瓣膜具有作为网格间隔框架的一部分的内反流控制部件，所述内反流控制部件被示出为被移除以供观察；以及具有网格侧壁覆盖件、内框架以及缝合到内框架中的小叶的外圆柱体框架。
图11是根据本发明的瓣膜的顶部透视图的图示，所述瓣膜具有作为网格间隔框架的一部分的具有不透射线标记物的内反流控制部件，所述内反流控制部件安装在外圆柱体框架的顶部边缘上，外框架还具有网格侧壁覆盖件、内框架和缝合到内框架中的小叶。
图12是根据本发明的瓣膜的底部透视图的图示，所述瓣膜具有作为网格间隔框架的一部分的安装在外圆柱体框架的顶部边缘上的内反流控制部件，外框架还具有网格侧壁覆盖件、内框架和缝合到内框架中的小叶。
图13是根据本发明的瓣膜的分解图的图示，所述瓣膜具有内反流控制部件、外圆柱体框架，外框架具有网格侧壁覆盖件、内框架和缝合到内框架中的小叶。
图14是根据本发明的处于圆柱体构型的内小叶框架的顶部透视图的图示，这作为允许折叠和压缩内框架的过程的开始示出。
图15是根据本发明的处于部分地折叠构型的内小叶框架的顶部透视图的图示，其中线框架侧壁在其侧向连接点处旋转或铰接，这作为允许折叠和压缩内框架的过程的部分第一步骤示出。
图16是根据本发明的处于完全折叠构型的内小叶框架的侧视图的图示，其中线框架侧壁在其侧向连接点处旋转或铰接，这作为允许折叠和压缩内框架的过程的完成第一步骤示出。
图17是根据本发明的处于折叠和竖直地压缩构型的内小叶框架的侧视图的图示，其中线框架侧壁以打褶或手风琴式折叠构型竖直地压缩，这作为允许折叠和压缩内框架的过程的第二步骤示出。
图18是根据本发明的在进一步组装成圆柱体结构之前作为线性线框架板材的内小叶框架的侧视图的图示。
图19是根据本发明的处于圆柱体或圆柱状(锥形等)构型的内小叶框架的侧透视图的图示。
图20是根据本发明的心包组织带的侧透视图的图示，所述带以圆柱体形状被构造成具有缝合到结构带中的小叶囊袋。
图21是根据本发明的在组装成圆柱形小叶部件并安装在内框架上以形成可塌缩(可折叠、可压缩)流量控制部件之前具有缝合到结构带中的小叶囊袋的心包组织带的侧视图的图示。
图22是根据本发明的在组装成圆柱形小叶部件并安装在内框架上以形成可塌缩(可折叠、可压缩)流量控制部件之前具有缝合到结构带中的小叶囊袋的心包组织带的底部视图的图示。
图23是根据本发明的具有缝合到结构带中的单个小叶囊袋的心包组织带的一部分的侧透视图的图示，其示出开放底部边缘和缝合的闭合顶部抛物线边缘。
图24是根据本发明的示出小叶的部分接合以形成闭合流体密封件的圆柱形小叶部件的底部视图的图示。
图25(a)至图25(e)是过程的图示，其中将具有预穿孔鼓内的瓣膜正交递送在导管内、从导管排出并部署到天然环中。
图26是根据本发明的处于圆柱体构型的外线框架的顶部透视图的图示，这作为允许折叠和压缩外框架的过程的开始示出。
图27是根据本发明的处于部分地折叠构型的外框架的顶部透视图的图示，其中线框架侧壁在其侧向连接点处旋转或铰接，这作为允许折叠和压缩内框架的过程的部分第一步骤示出。
图28是根据本发明的处于完全平折构型的外框架的侧视图的图示，其中线框架侧壁在其侧向连接点处旋转或铰接，这作为允许折叠和压缩内框架的过程的完成第一步骤示出。
图29是根据本发明的处于折叠和竖直地压缩构型的外框架的侧视图的图示，其中线框架侧壁以打褶或手风琴式折叠构型竖直地压缩，这作为允许折叠和压缩内框架的过程的第二步骤示出。
图30是根据本发明的组装后瓣膜的顶部透视图的图示，所述组装后瓣膜具有带有不透射线标记物的内反流控制部件、外框架、具有内小叶框架和三个缝合小叶囊袋/尖瓣的流量控制部件、内间隔框架以及位于间隔框架上方的网格覆盖件，折叠线在网格覆盖件上被示出为虚线。
图31是根据本发明的组装后瓣膜的顶部透视图的图示，所述组装后瓣膜具有带有不透射线标记物的内反流控制部件和外框架、邻近流量控制部件安装在外框架上的第一子环形锚定/定位突片、安装在外框架上不同位置的第二子环形锚定/定位突片、具有内小叶框架和三个缝合小叶囊袋/尖瓣的流量控制部件、内间隔框架以及位于间隔框架上方的网格覆盖件，折叠线在网格覆盖件上被示出为虚线。
图32是根据本发明的组装后瓣膜的顶部透视图的图示，所述组装后瓣膜具有外框架、邻近流量控制部件安装在外框架上的第一子环形锚定/定位突片、安装在外框架上不同位置的第二子环形锚定/定位突片、具有内小叶框架和三个缝合小叶囊袋/尖瓣的流量控制部件、内间隔框架以及位于间隔框架上方的网格覆盖件，折叠线在网格覆盖件上被示出为虚线，并且血液动力学洗涤腔被示出为在所覆盖内间隔框架下方。
图33是根据本发明的组装后瓣膜的顶视图的图示，所述组装后瓣膜具有内反流控制部件和外框架、具有内小叶框架和三个缝合小叶囊袋/尖瓣的流量控制部件、内间隔框架以及位于间隔框架上方的网格覆盖件。
图34是根据本发明的组装后瓣膜的顶视图的图示，所述组装后瓣膜具有内反流控制部件和外框架、邻近流量控制部件安装在外框架上的第一子环形锚定/定位突片、安装在外框架上不同位置的第二子环形锚定/定位突片、具有内小叶框架和三个缝合小叶囊袋/尖瓣的流量控制部件、内间隔框架以及位于间隔框架上方的网格覆盖件。
图35(a)至图35(e)是逐步过程的图示，其中在将瓣膜正交装载到递送导管中之前对组织鼓进行穿孔。
图36(a)至图36(c)是逐步过程的图示，其中在将瓣膜从递送导管正交地排出并部署到天然环中之后对组织鼓进行穿孔。
图37是用户可如何使孔口的大小与期望的反流量(例如，0.5-2.0范围内的反流等级)匹配的图示。
图38是用户可如何与管状支架的管腔的大小匹配的图示，所述管腔可部署到孔口中以与期望的反流量(例如，0.5-2.0范围内的反流等级)匹配。
图39是根据本发明的带标签瓣膜的侧中隔平面图的图示，所述带标签瓣膜具有朝向观察者延伸的子环形锚定和/或定位突片和远离观察者延伸的第二子环形突片，并且具有可见的可折叠且可压缩线框架构造。
图40(a)至图40(f)是用于闭合内反流控制部件中的穿孔的闭合装置的图示。
图41是根据本发明的部分地从递送导管排出的瓣膜的顶视图的图示，其中远端突片将瓣膜(沿着未示出的引导线)引向部署位置，远端流量控制部件开始打开，并且示出三个小叶中的两个从折叠平展构型打开并且第三小叶从折叠构型打开，在折叠构型中，第三小叶在处于递送导管中时往回折叠在自身上。
图42是根据本发明的压缩(正交地装载)于递送导管内的瓣膜的顶视图的图示，其中第一突片沿着x轴向前延伸并且第二后缘突片沿着x轴向后延伸。
图43是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架、偏心内流量控制部件(小叶在框架中)和不规则形状的间隔框架/支撑框架。
图44是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架、居中地定位的内流量控制部件(小叶在框架中)和位于内流量控制部件的相反侧上的一对不规则形状的间隔框架/支撑框架。
图45是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架和内流量控制部件(小叶在框架中)和多个缝合附接点，其中内流量控制部件被缝合到外框架。
图46是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有安装在第二内反流控制部件中穿孔内的起搏器引线组、外框架、偏心内流量控制部件和内间隔框架，所有三个结构都可沿着同一x轴折叠。
图47是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架、居中地定位的内流量控制部件以及安装在内流量控制部件的相反侧上以在外框架的内部尺寸内提供支撑的一对较小圆柱形内间隔框架，所有四个结构都可沿着同一x轴折叠。
图48是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架、近端地定位的偏置内流量控制部件和远端侧内间隔框架，所有三个结构都可沿着同一x轴折叠。
图49是根据本发明的具有经股骨/IVC或SVC递送导管的人类心脏的侧视图的图示，所述递送导管已排出正交人工瓣膜以用于低角度部署进入三尖瓣膜。
具体实施方式
本发明涉及一种双突片经导管心脏瓣膜置换物，所述置换物是一种低剖面、正交递送的可植入人工心脏瓣膜，所述可植入人工心脏瓣膜具有环状或环形支撑框架、内2或3面板套管、延伸到右心室流出道中的细长子环形远端锚定突片、延伸到近端子环形空间中、优选地前小叶与后小叶之间的细长子环形近端锚定突片。
参考在附图中示出并在以下描述中详述的非限制性实施方案，更全面地解释本文实施方案及其各种特征和有利细节。省略了对众所周知的组分和加工技术的描述，以免不必要地模糊本文中的实施方案。本文中所使用的实例仅仅是为了便于理解可用来实践本文中的实施方案的方式，并且进一步使得本领域的技术人员能够实践本文中的实施方案。因此，实例不应解释为限制本文中的实施方案的范围。
相反，提供这些实施方案是为了使本公开彻底和完整，并且将本发明的范围完全传达给本领域技术人员。通篇相同标号指代相同元件。如本文所使用术语“和/或”包括相关联的所列项中的一个或多个的任何和所有组合。
本文所用的术语仅为了描述特定实施方案，并且并不意图限制本发明的全部范围。除非上下文中另有明确指示，否则本文所用的单数形式“一”、“一个”和“所述”也意在包括复数形式。将进一步理解，术语“包括(comprises)”和/或“包括(comprising)”在用于本说明书中时，规定存在所陈述的特征、整数、步骤、操作、元件和/或部件，但是不排除存在或添加一个或多个其他特征、整数、步骤、操作、元件、部件和/或其群组。
除非另外定义，否则本文所用的所有技术性和科学性术语具有与本领域普通技术人员通常所理解的相同含义。本公开中的任何内容均不应解释为承认本公开中所描述的实施方案无权凭借在先发明而先于此类公开。如本文献中所用，术语“包括”意指“包括但不限于”。
可在不脱离本公开精神和范围的情况下作出许多修改和变化，这对于本领域技术人员来说是显而易见的。除本文所枚举的那些之外，在本公开的范围内的功能上等效的方法和设备根据前述描述对于本领域技术人员来说是显而易见的。这类修改和变化旨在落入所附权利要求的范围内。本公开仅受所附权利要求的项以及这类权利要求所授权的等效物的全部范围限制。应当理解，本公开不限于特定的方法、试剂、化合物、组合物或生物系统，它们当然可以变化。还应当理解，本文所使用的术语仅是用于描述特定实施方案的目的，并且不意图具有限制性。
关于本文中对基本上任何复数和/或单数术语的使用，本领域技术人员可根据环境和/或应用酌情从复数转化为单数和/或从单数转化为复数。为清楚起见，本文可能明确陈述各种单数/复数排列。
本领域技术人员应了解，一般来说，在本文并且尤其在随附权利要求(例如，随附权利要求的主体)中使用的术语通常意图为“开放”术语(例如，术语“包括(including)”应解释为“包括但不限于”，术语“具有”应解释为“至少具有”，术语“包括(includes)”应解释为“包括但不限于”等)。本领域技术人员还将理解，无论在说明书、权利要求还是附图中，呈现两个或更多个替代项的几乎任何转折词和/或短语应被理解为设想到包括项中的一个、项中的任一个或两个项的可能性。例如，短语“A或B”将理解为包括“A”或“B”或“A和B”的可能性。
此外，在根据Markush组描述了本公开的特征或方面的情况下，本领域技术人员将认识到本公开还因此根据Markush组的任何个别成员或成员子组进行了描述。
如本领域技术人员将理解，出于任何和所有目的，诸如在提供书面描述方面，本文所公开的所有范围还涵盖任何和所有可能的子范围及其子范围的组合。任何列出的范围可容易地被识别为充分地描述和使得同一范围能够被分成至少相等的子部分。如本领域技术人员将理解的，范围包括每一单独成员。
定义
正交
在本文的说明书和权利要求中，术语“正交”用于描述与传统经导管心脏瓣膜相比，本发明的瓣膜以大致90度角被压缩和递送。传统瓣膜具有平行于递送导管的纵向轴线的中心圆柱轴线，并且以类似于将闭合伞推出套管的方式从递送导管的端部部署。本发明的瓣膜以侧向方式进行压缩和递送。传统瓣膜只可扩张到递送导管内径将允许的范围内。努力增加传统瓣膜的扩张直径遇到了试图将太多材料和结构压缩到太小的空间中的问题。
在数学上，术语正交是指两条线或平面之间的相交角为90度。如本文所用，术语“基本上正交”是指范围从75度到105度的相交角。相交角或正交角是指如下两者：(i)递送导管的纵向圆柱轴线与本发明的压缩瓣膜的长轴之间的关系，其中长轴垂直于传统瓣膜的中心圆柱轴线，和(ii)本发明的压缩或扩张瓣膜的长轴与由通过人工心脏瓣膜的血流所定义的轴线之间的关系，其中血液例如从身体的一个部位或心脏的腔室流动到身体的另一下游部位或心脏的腔室，诸如通过天然环从心房流动到心室。
经导管
在本文的说明书和权利要求中，术语“经导管”用于定义在部署到心脏腔室中的导管的管腔内进入、控制和递送医疗装置或器械的过程，以及通过这种过程递送或控制的项目。已知经导管通路包括经由股动脉和股静脉、经由肱动脉和静脉、经由颈动脉和颈静脉、经由肋间(肋)空间以及经由剑突下。经导管可与经腔同义，并且在功能上与术语“经皮”相关，因为它涉及心脏瓣膜的递送。
在本发明的优选实施方案中，经导管入路包括(i)经由股静脉通过下腔静脉推进到心脏的三尖瓣膜或肺动脉，(ii)经由颈静脉通过上腔静脉推进到心脏的三尖瓣膜或肺动脉，(iii)经由IVC-股或SVC-颈静脉入路通过经心房途径(例如，卵圆窝或更低)推进到心脏的二尖瓣膜。
环形支撑框架
在本文的说明书和权利要求中，术语“环形支撑框架”以及“线框架”或“凸缘或套环”是指安置在天然瓣膜环内并且用作用于小叶结构、流量控制部件或柔性往复式套管或套管瓣膜的安装元件的三维结构部件。
在优选实施方案中，环形支撑框架是自扩张环形支撑框架，具有中心通道和在扩张构型中外接中心竖直轴线的外周边壁。周边壁包含套环和下体部分。
周边壁可进一步定义为具有前壁部分和后壁部分，所述前壁部分和后壁部分沿着近侧(到IVC)或近端侧连接到近端折叠区域，并且沿着远侧或远端侧连接到远端折叠区域。
此前壁部分可进一步定义为具有前上部套环部分和前下部主体部分，并且后壁部分可进一步限定为具有后上部套环部分和后下部主体部分。
环形支撑框架具有安装在环形支撑框架内并且被构造来允许沿第一方向通过瓣膜的流入端部的血流并且阻止沿与第一方向相反的第二方向通过瓣膜的流出端部的血流。
由于框架优选地由超弹性金属或合金(诸如镍钛诺)制成，因此框架是可压缩的。优选地，框架由多个可压缩线单元构成，所述多个可压缩线单元具有基本上正交于中心竖直轴线以在环形支撑框架被构造为竖直压缩构型、卷取压缩构型或折叠压缩构型时最小化线单元应变的取向和单元几何结构。
环形支撑框架结构
环形支撑框架可为由耐用的生物相容性结构材料(诸如镍钛诺或类似合金)制成的环形、或圆柱形或锥形管，其中环形支撑框架通过将结构材料制造为编织线框架、激光切割线框架或线圈形成。考虑到线材料自身的厚度，环形支撑框架的高度为约5-60mm，所具有的外径尺寸R为30-80mm，并且内径尺寸为31-79mm。
如上所陈述，环形支撑框架可具有环形状、圆柱体形状、锥形管形状的侧轮廓，但也可具有扁平圆锥形状、倒扁平圆锥形状(顶部较窄、底部较宽)、凹圆柱体(壁向内弯曲)、凸圆柱体(壁向外凸出)、成角度沙漏、弯曲带刻度沙漏、具有喇叭形顶部、喇叭形底部或两者的环或圆柱体。在一个优选实施方案中，在部署在三尖瓣环中的人工心脏瓣膜中所用的环形支撑框架可具有由安装瓣膜的解剖结构确定的复杂形状。例如，在三尖瓣环中，三尖瓣膜的圆周可为圆的椭圆，已知中隔壁是基本上垂直的，并且已知三尖瓣在疾病状态下沿着前后线扩大。因此，人工心脏瓣膜可以大致管状构型开始，并且可被热成型来提供用于心房密封的上部心房套囊或凸缘和下部经环管状或圆柱形部段，所述下部经环管状或圆柱形部段的圆周的约60-80％具有沙漏形横截面以沿着后环形段和前环形段与天然环相符，同时沿着环形圆周的20-40％保持基本上竖直地扁平以与中隔环形段相符。
环形支撑框架覆盖物
环形支撑框架任选地在内部或在外部部分地或完全地覆盖有生物相容性材料，诸如心包。环形支撑框架也可任选地在外部部分地或完全地覆盖有第二生物相容性材料，诸如聚酯或Dacron(R)。
环形支撑框架用途
环形支撑框架具有中心轴向管腔，其中人工心脏瓣膜或流量控制结构(诸如往复式可压缩套管)跨管腔的直径被安装。环形支撑框架还抵靠天然环的内面张紧，并且向弱化的环形环提供结构通畅性。
环形支撑框架任选套环
环形支撑框架可任选地具有附接到框架的上部(心房)边缘用于部署在心房底上的单独心房套环，所述单独心房套环用于将血液从心房导引到套管中并且进行密封以防环形支撑框架周围发生血液泄漏。环形支撑框架还可任选地具有附接到框架的下部(心室)边缘用于部署在紧靠天然环下面的心室中的单独心室套环，所述单独心室套环用于防止在心脏收缩期间发生反流泄漏，防止装置在心脏收缩期间移动，将天然环或邻近组织夹置或压缩在心房套环上，并且任选地附接到并支撑套管/管道。
环形支撑框架递送
环形支撑框架可被压缩以用于经导管递送并且可能够作为自扩张形状记忆元件或使用经导管扩张球囊而扩张。一些实施方案可具有心房套环和心室套环两者，而本发明范围内的其他实施方案包括具有单个心房套环、单个心室套环或不具有另外的套环结构的人工心脏瓣膜。
框架材料
优选地，框架由超弹性金属部件诸如激光切割镍钛诺管、或扁平板或其他类似功能的材料(诸如编织线)制成。材料可用于框架/支架、套环和/或锚定件。设想在本发明的范围内使用其他形状记忆合金以及聚合物复合材料，包括含有碳纳米管、碳纤维、金属纤维、玻璃纤维和聚合物纤维的复合材料。设想框架可构造为编织物、线或激光切割框架。激光切割框架优选地由镍钛诺制成，但也不限于由不锈钢、钴铬、钛和其他功能上等效的金属和合金制成。
框架设计的一个关键方面在于它是可压缩的，并且在释放时具有它恢复到其原始(未压缩)形状的所述性质。此要求将潜在的材料选择限制为具有形状记忆性质的金属和塑料。关于金属，已发现镍钛诺尤其有用，因为它可被加工成奥氏体、马氏体或超弹性体。可加工马氏体和超弹性合金以展示所需机械行为。
激光切割
线框架的一种可能构造设想激光切割等径的镍钛诺细管。激光切割在镍钛诺细管中形成规则切口。在一个优选实施方案中，镍钛诺管扩张以形成由菱形单元形成的三维结构。结构还可具有用于附接附属部件诸如生物相容性覆盖件、组织锚定件、可释放部署和取回控制引导件、旋钮、附接件、索具等的另外的功能元件，例如，圈、锚定件等。
其次，使用行业标准的镍钛诺成型方法来对管进行热机械加工。以此方式处理线框架将形成具有形状记忆性质并且一旦被部署就将容易地恢复到记忆形状的装置。
编织线
线框架的另一种可能构造设想利用简单编织技术，其使用镍钛诺线和简单编织夹具。线以一定图案缠绕在编织夹具上，直到形成等径管为止。其次，将编织线框架放置在成型夹具上，并且使用行业标准的镍钛诺成型方法进行加工。
流量控制部件
在本文的说明书和权利要求中，术语“流量控制部件”在非限制性意义上是指具有含柔性生物相容性材料(诸如处理后或未处理心包)的2个小叶、3个小叶、4个叶的小叶结构，所述小叶结构缝合或连结到内环形支撑框架(安装在外环形支撑框架内)，以用作人工心脏瓣膜。这种瓣膜可为心脏瓣膜，诸如三尖瓣、二尖瓣、主动脉瓣或肺动脉瓣，所述心脏瓣膜对在舒张期间从心房流向心室的血液开放，并且由于施加到外表面的收缩期心室压力而闭合。依次重复开合可描述为“往复式”。
反流鼓或第二内
在本文的说明书和权利要求中，术语“反流鼓”或“第二内反流控制部件”是指靠近于第一内环形支撑框架安装在外环形支撑框架内的第二内环形支撑框架。“反流鼓”或“第二内反流控制部件”具有可折叠且可压缩框架、附接到所述框架的组织覆盖件以及安装在加强环内的流量调节器，所述加强环安装在所述组织覆盖件上，所述流量调节器选自通道、封堵器、管状支架以及在其管腔内具有封堵器的管状支架，所述组织覆盖件具有一个或多个不透射线标记物。这种“反流鼓”或“第二内反流控制部件”可在将瓣膜装载到递送导管中之前被预穿孔，它可在已将瓣膜部署到天然环中之后使用导管工具进行穿孔，穿孔可使用支架管加强，并且穿孔或支架管可使用闭合装置密封，所述闭合装置诸如聚酯碟、镍钛诺碟、具有聚酯覆盖件的镍钛诺碟、双碟(每侧上有按钮)闭合装置或类似于用于治疗卵圆孔未闭，但被修改以用于进入并闭合反流鼓中例如1-2mm穿孔的装置的功能上类似装置。
加强环
术语加强环是指安装在“反流鼓”或“第二内反流控制部件”的组织覆盖件的顶部表面上的具有诸如如下的材料的环：心包、聚合物或生物相容性材料。在优选实施方案中，加强环外接用于穿孔的目标区域并且防止穿孔撕裂或失去通畅性。在另一优选实施方案中，用于引导导管切割/球囊工具的不透射线标记物可安装在加强环的顶部上或其内。
不透射线标记物
术语“不透射线标记物”是指在荧光透视检查或其他放射成像期间允许可视性的材料。不透射线标记物材料的实例包括镍钛诺、金、铂及它们的组合或混合物。不透射线材料还可包括包含在聚合物、玻璃或陶瓷基质内的粉末状或颗粒金属。本发明设想使用一个或多个标记物，例如，1-10个或3-5个标记物。本发明设想使用以特定图案或取向安装的标记物，以不仅提供靶向穿孔位置，而且提供针对瓣膜自身的定位信息。例如，使用三种标记物图案提供中心靶向区域，但也可提供关于瓣膜是否正确地取向，诸如使人工瓣膜的中隔套环部分与三尖瓣膜的中隔侧对齐的信息。
组织锚定件
在本文的说明书和权利要求中，术语“组织锚定件”或“折襞组织锚定件”或“辅助组织锚定件”或“镖件”或“销”是指通常在套环的周边处或其附近将上部心房框架连接到天然环形组织的紧固装置。锚定件可定位为避免刺穿组织并且仅依赖于两个板状套环对所捕获组织的压缩力，或者锚定件自身或与整合式固定线一起可刺穿天然组织以提供锚定，或者两者的组合。锚定件可具有插入或弹出到配对孔口或配对孔口阵列中的专门固定机构，诸如具有沟槽和带凸缘肩台的尖端，所述配对孔口或配对孔口阵列允许锚定件附接，但在孔口周边靠近带凸缘肩台锁定到沟槽中时防止脱离。固定线可通过任何附接或锚定机构附接或锚定到与销相对的套环，所述任何附接或锚定机构包括结节、缝合线、线压接件、具有凸轮机构的线锁或它们的组合。
支撑柱
术语“支撑柱”是指可安装在辐条式框架上并且轴向地、或沿柔性套管的中心向下、或在柔性套管的缝合接缝内延续的刚性或半刚性长度的材料，诸如镍钛诺或PEEK。套管可不附接到支撑柱，或者套管可直接或间接地附接到支撑柱。
在以下描述中，术语“身体通道”用于定义身体内的血液导管或血管。当然，人工心脏瓣膜的特定应用决定所讨论的身体通道。例如，主动脉瓣膜置换物将被植入主动脉环中或邻近于主动脉环植入。同样，三尖瓣膜或二尖瓣膜置换物将被植入在三尖瓣环或二尖瓣环处。本发明的某些特征对于一个或另一个植入部位特别有利。然而，除非组合在结构上是不可能的，或者被权利要求语言排除，否则本文所描述的心脏瓣膜实施方案中的任一个可被植入任何身体通道中。
术语“管腔”是指圆柱体管的内侧。术语“镗孔”是指内径。
排量–一个完整冲程或转动所排出的流体体积。
射血分数是每次心脏收缩时离开心脏的血液百分比的量度。在每个心跳泵送周期期间，心脏收缩和舒张。当心脏收缩时，它从两个泵送腔室(心室)射出血液。
如本文所用，术语“近端”和“远端”应理解为是相对于所公开递送装置的用户(例如，外科医生或介入心脏病专家)而言的。“近端”应理解为相对靠近用户，并且“远端”应理解为相对远离用户。
作为进一步定义点，术语“可扩张”在本文中用于是指能够从第一递送直径扩张到第二植入直径的心脏瓣膜的部件。因此，可扩张结构并不意指可能因温度升高或其他此类偶然原因而发生轻微扩张的结构。相反，“不可扩张”不应解释为意指完全刚性或尺寸上稳定的，因为可观察到例如常规“不可扩张”心脏瓣膜的一些轻微扩张。
人工心脏瓣膜
术语假体或人工的包含如下两者：完全置换解剖部分，例如新机械瓣膜置换天然瓣膜，以及替代和/或辅助、修复或改进现有解剖部分，例如天然瓣膜被留在原位的医疗装置。为了安装在被动辅助保持架内，本发明设想广泛多种(生物)人工人造心脏瓣膜。设想在本发明范围内的是球瓣膜(例如，Starr-Edwards)、双小叶瓣膜(St.Jude)、倾斜式碟瓣膜(例如，Bjork-Shiley)、(牛的、猪的、羊的)带支架心包心脏瓣膜假体(Edwards系列的生物假体、St.Jude人工心脏瓣膜)以及同种移植和自体移植瓣膜。对于生物人工心包瓣膜，设想使用生物人工主动脉瓣膜、生物人工二尖瓣膜、生物人工三尖瓣膜和生物人工肺动脉瓣膜。
拴系件
拴系件由外科级材料(诸如生物相容性聚合物缝合材料)制成。此类材料的非限制性实例包括超高分子量聚乙烯(UHMWPE)、2-0exPFTE(聚四氟乙烯)或2-0聚丙烯。在一个实施方案中，拴系件是非弹性的。还设想，拴系件中的一个或多个可任选地是弹性的，以在心动周期期间提供瓣膜的甚至进一步的顺应性程度。
钉齿-锚定件-钉齿/倒钩
装置可通过使用钉齿或倒钩安置在瓣膜环内。这些可结合或代替一个或多个拴系件使用。钉齿或倒钩定位成与邻近组织提供附接。通过机械手段诸如使用球囊导管将钉齿压入环形组织中。在一个非限制性实施方案中，钉齿任选地可为在线框架主体扩张时刺穿、旋转进入并牢固地保持环形组织的半圆形钩。锚定件通过一个或多个锚定件穿过递送导管在线之上进行递送来部署。导管可具有多个轴向管腔以用于递送各种锚定工具，包括锚定设置工具、力施加工具、钩、勒除工具、切割工具、射频和放射性可视化工具和标记物以及缝合线/丝线操纵工具。一旦一个或多个锚定件附接到调节带，就可使用张紧工具来调整连接到植入瓣膜的拴系件的长度，以针对适当功能根据需要调整和固定植入物。还设想，锚定件可为弹簧加载的并且可具有内置于一个或多个锚定件的拴系面中的拴系件附接机构或拴系件捕获机构。锚定件也可具有内生长材料(诸如聚酯纤维)，以促进锚定件内生长到心肌中。
在其中人工心脏瓣膜可以或可以不包括心室套环的一个实施方案中，锚定件或镖件并不附接到下部心室套环，而是直接附接到环形组织或用于锚定的其他组织中。
管和/或覆盖材料-生物组织
本文所用的组织是生物组织，所述生物组织是动物的化学稳定的心包组织，诸如牛(牛的心包)或羊(羊的心包)或猪(猪的心包)或马(马的心包)。优选地，组织是牛的心包组织。合适组织的实例包括用于产品
Figure BDA0003245252020000241
和
Figure BDA0003245252020000242
的组织，所有产品当前用于外科规程并且销售为通常从小于30个月大的家畜收获。其他专利和公布公开了所收获的生物相容性动物薄组织在本文中适合作为用于可植入支架的生物相容性“护套”或套管的外科用途，包括例如授予Block的美国专利5,554,185；授予Design&Performance-Cyprus Limited的美国专利7,108,717，其公开覆盖支架组件；授予ScimedLife Systems,Inc.的美国专利6,440,164，其公开用于植入的生物人工心脏瓣膜；以及授予LifeCell Corporation的美国专利5,336,616，其公开用于移植的非细胞胶原基组织基质。
聚合物
在一个优选实施方案中，导管任选地可由合成材料(诸如聚氨酯或聚四氟乙烯)制成。
在薄的耐用合成材料被设想例如用于覆盖物的情况下，可任选地使用合成聚合物材料，诸如膨体聚四氟乙烯或聚酯。其他合适材料可任选地包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、链段聚醚聚氨酯、硅酮聚醚聚氨酯、硅酮-聚碳酸酯聚氨酯和超高分子量聚乙烯。另外的生物相容性聚合物可任选地包括聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯吡咯烷酮、聚氯乙烯、其他含氟聚合物、硅酮聚酯、硅氧烷聚合物和/或低聚物、和/或聚内酯以及使用它们的嵌段共聚物。
聚酰胺(PA)
PA是一种早期发明的工程热塑性塑料，其由分子量大于10,000的“超级聚酯”纤维组成。它通常被称为尼龙。聚酰胺的应用包括用于心血管应用的透明管材、血液透析膜以及生产经皮腔内冠状动脉成形术(PTCA)导管。
聚烯烃
聚烯烃包括聚乙烯和聚丙烯，它们是聚烯烃的两种重要聚合物并且具有较好生物相容性和耐化学性。在心血管用途中，低密度聚乙烯和高密度聚乙烯两者用于制造管材和外壳。聚丙烯用于制造心脏瓣膜结构。
聚酯
聚酯包括使用名称为Dacron的聚对苯二甲酸乙二酯(PET)。它通常用作血管移植物的针织或者编织织物。与针织织物相比，编织PET具有更小孔隙，这减少了血液渗漏并且作为血管移植物具有更好效率。PET移植物也可用于蛋白质涂层(胶原或白蛋白)以用于减少失血并且具有更好生物相容性[39]。已搜索到具有内皮细胞的PET血管移植物作为用于提高通畅率的手段。此外，聚酯是用于制造生物可吸收支架的广泛优选材料。聚-L-乳酸(PLLA)、聚乙醇酸(PGA)和聚(D，L-丙交酯/乙交酯)共聚物(PDLA)是常用生物可吸收聚合物中的一些。
聚四氟乙烯
聚四氟乙烯(PTFE)是Dupont Co.的合成氟碳聚合物，通用商品名为特氟龙。PTFE在心血管工程中的常见应用包括血管移植物和心脏瓣膜。PTFE缝合线用于粘液瘤疾病的二尖瓣膜的修复，并且也用于二尖瓣膜的前小叶或后小叶脱垂的外科手术。PTFE特别地用于可植入人工心脏瓣膜环。它在装置被植入高流量、大直径动脉(诸如主动脉)中时已成功地用作血管移植物。当它被植入在主动脉杈下方时会出现问题，并且探索了称为细长PTFE(e-PTFE)的另一种形式的PTFE。膨体PTFE是通过在专业培养基存在下压缩PTFE并最终挤出混合物而形成的。然后将通过此过程形成的挤出物加热至接近其玻璃化转变温度并拉伸以获得称为e-PTFE的微观下多孔PTFE。这种形式的PTFE被指示用于更小动脉，其具有更低流速、促进低血栓形成性、更低再狭窄率和止血率、更少钙化和生化惰性。
聚氨酯
聚氨酯具有良好的物理化学性质和机械性质，并且具有高度生物相容性，这允许在血液接触装置中不受限制地使用。它具有高剪切强度、弹性和透明度。此外，聚氨酯的表面对微生物具有良好抗性，并且由PU产生的血栓形成几乎与多功能心血管生物材料(如PTFE)类似。常规地，嵌段聚氨酯(SPU)已用于各种心血管应用，诸如瓣膜结构、起搏器引线和心室辅助装置。
覆盖线框架材料
设想在本文使用药物洗脱线框架。DES基本上由三个部分组成：线框架平台、涂层和药物。不含聚合物的DES的实例中的一些是Amazon Pax(MINVASYS)，其使用AmazoniaCroCo(L605)钴铬(Co-Cr)线框架，并且紫杉醇作为抗增殖剂，并且腔内涂层已用作药物的载体。BioFreedom(Biosensors Inc.)，其使用不锈钢作为基底，并且改性的腔内涂层作为用于抗增殖药物Biolimus A9的载体表面。Optima(CID S.r.I.)，其使用316L不锈钢线框架作为用于药物他克莫司的基底，并且利用整合式涡轮层碳膜作为药物载体。VESTA sync(MIV Therapeutics)，其使用GenX不锈钢(316L)作为基底，利用微孔羟基磷灰石涂层作为用于药物西罗莫司的载体。YUKON choice(Translumina)，其使用316L不锈钢作为用于西罗莫司与普罗布考组合药物的基底。
生物可吸收聚合物也可在本文中用作用于药物的载体基质。Cypher、Taxus和Endeavor是生物可吸收DES的三种基本类型。Cypher(J&J,Cordis)使用涂覆有聚乙烯乙酸乙烯酯(PEVA)和聚甲基丙烯酸丁酯(PBMA)的316L不锈钢来携载药物西罗莫司。Taxus(Boston Scientific)利用涂覆有translute苯乙烯异戊二烯丁二烯(SIBS)共聚物的316L不锈钢线框架来携载紫杉醇，所述紫杉醇在约90天的时间段内洗脱。Endeavor(Medtronic)使用钴铬驱动线框架来携载佐他莫司，其中磷酰胆碱作为药物载体。BioMatrix采用具有聚乳酸表面的S-线框架(316L)不锈钢作为基底来携载抗增殖药物Biolimus。ELIXIR-DES项目(Elixir Medical Corp)包含聚酯和聚丙交酯两者涂覆的线框架来携载药物诺沃莫司并且钴铬(Co-Cr)作为基底。JACTAX(Boston Scientific Corp.)利用D-乳酸聚乳酸(DLPLA)涂覆的(316L)不锈钢线框架来携载紫杉醇。NEVO(Cordis Corporation,Johnson&Johnson)使用涂覆有聚乳酸-乙醇酸共聚物(PLGA)的钴铬(Co-Cr)线框架来携载药物西罗莫司。
优选实施方案的实例包括以下细节和特征。
示例性-递送方法
经导管人工心脏瓣膜可使用经导管过程经由股骨穿过IVC、颈动脉、剑突下、横穿胸壁的肋间通路以及穿过卵圆窝经中隔到达二尖瓣环而经皮地递送。
装置经由导管递送到右心房或左心房，并且从适合导管管腔的内径的压缩形状扩张。压缩瓣膜在患者体外被装载到递送导管中，并且然后在胶囊到达心房时被推出导管。心脏治疗技术人员使用可用成像技术(诸如荧光透视检查或超声波)来可视化这种递送。
在优选实施方案中，瓣膜在从导管释放时自扩张，因为它部分地由形状记忆材料构成，所述形状记忆材料诸如
Figure BDA0003245252020000281
镍钛合金或钴铬合金、生物医学植入物中所用的合金。
在另一实施方案中，瓣膜可由在胶囊已从导管射出到心房中之后需要球囊扩张的材料构成。
心房套环/框架和流量控制部件在它们部署到天然环中时扩张至其功能直径，从而提供径向张力以便固定瓣膜。一旦框架围绕三尖瓣环或二尖瓣环部署，紧固件就将装置围绕天然环固定。可执行装置到天然结构的另外的紧固，并且部署完成。使用血液动力学成像技术的进一步调整被设想为在本发明的范围内，以便确保装置是安全的，按计划定位和取向，并且用作天然三尖瓣膜的替代物或后继者。
示例性-递送方法
在本发明的另一优选实施方案中，提供一种用于在体内正交递送可植入人工心脏瓣膜的方法，所述方法包括以下步骤：(i)将引导线的远端端部推进到远端位置，其中远端位置是肺动脉或心脏的左心室，其中引导线使用股静脉通路或头臂静脉通路从患者体外开始，并且通过下腔静脉或上腔静脉延伸到右心房，并且从右心房通过三尖瓣膜延伸到肺动脉，或从右心房横穿经室中隔通路中的心房中隔延伸通过二尖瓣膜并且进入左心室中；(ii)将递送导管在引导线之上推进到目标位置，其中目标位置是三尖瓣膜的右心房或二尖瓣膜的左心房；(iii)推进正交地压缩的自扩张人工心脏瓣膜并将其递送到体内的目标位置，其中瓣膜的压缩构型具有基本上平行于递送导管的纵向圆柱轴线的长x轴，其中瓣膜的扩张构型具有约5-60mm的高度和约25-80mm的直径，其中瓣膜包括：环形支撑框架，所述环形支撑框架具有可塌缩流量控制部件，所述可塌缩流量控制部件安装在环形支撑框架内并且被构造来允许沿第一方向通过瓣膜的流入端部的血流并且阻止沿与第一方向相反的第二方向通过瓣膜的流出端部的血流，可塌缩(内)流量控制部件具有小叶框架，小叶框架上安装有2-4个柔性小叶，小叶框架可沿着z轴从圆柱形构型折叠为扁平圆柱体构型，并且可沿着竖直轴线(y轴)压缩为缩短构型，远端锚定突片安装在环形支撑框架的远端侧上，远端锚定突片具有10-40mm的长度和2-10mm的宽度，其中引导线螺纹穿过远端锚定突片上或内的螺纹孔口，至少一个近端锚定突片安装在环形支撑框架的近端侧上，近端锚定突片具有2-25mm的长度和2-10mm的宽度；以及瓣膜推进工具，所述瓣膜推进工具包括细长护套，其中引导线位于护套的管腔内，其中护套的外径大于远端锚定突片上的螺纹孔口的内径，其中当护套沿远端方向在引导线之上推进，并且护套的远端端部接触螺纹孔口的近端表面时，瓣膜通过护套施加到远端锚定突片的向远端导引的拉力向远端推进通过递送导管；(iv)通过在引导线之上推进护套并且将远端锚定突片定位在目标位置的期望锚定区域处来从递送导管部分地释放瓣膜，其中期望锚定区域选自右心室的右心室流出道(RVOT)和二尖瓣膜的Al-Pl前侧向连合下方的子环形区域，其中定位远端锚定突片将瓣膜保持在相对于瓣膜和递送导管的水平轴线与局部环形平面成至少30度的升高角度处，其中部分地释放瓣膜允许血液部分地围绕人工瓣膜流动并且流动通过天然小叶，并且部分地流动通过人工瓣膜的流量控制部件，以提供从通过天然小叶的流到通过人工瓣膜的完全流的逐渐血流转变；(v)通过在引导线之上推进护套来完成从递送导管释放整个瓣膜，从而通过沿心室方向施加向下力来将瓣膜安置在天然环中；以及(vi)将至少一个近端锚定突片安置在第二期望锚定区域处。
示例性-递送方法
在本发明的另一优选实施方案中，提供一种用于将可植入人工心脏瓣膜正交递送到体内的期望位置(包括三尖瓣膜位置)的方法，所述方法包括以下步骤：将递送导管推进到体内的期望位置并且通过从递送导管释放瓣膜来将可扩张人工心脏瓣膜递送到体内的期望位置，其中瓣膜包括环形支撑框架，所述环形支撑框架具有：可塌缩流量控制部件，所述可塌缩流量控制部件安装在环形支撑框架内并且被构造来允许沿第一方向通过瓣膜的流入端部的血流并且阻止沿与第一方向相反的第二方向通过瓣膜的流出端部的血流，可塌缩(内)流量控制部件具有小叶框架，小叶框架上安装有2-4个柔性叶，小叶框架可沿着z轴从圆柱形构型折叠为扁平圆柱体构型并且可沿着竖直轴线(y轴)压缩为缩短构型；远端锚定突片，所述远端锚定突片安装在环形支撑框架的远端侧上；以及近端锚定突片，所述近端锚定突片安装在环形支撑框架的近端侧上，其中瓣膜可压缩为压缩构型以用于使用递送导管引入到体内以便植入体内的期望位置处，所述压缩构型所具有的长轴取向成与第一方向成介于45-135度之间的相交角，并且所述压缩构型可扩张为所具有的长轴取向成与第一方向成介于45-135度之间的相交角的扩张构型，其中瓣膜的压缩构型的长轴基本上平行于递送导管的纵向圆柱轴线，其中压缩构型，其中瓣膜具有约5-60mm的高度和约25-80mm的直径。
从递送导管释放瓣膜选自由如下组成的步骤：(i)使用可释放地连接到瓣膜的远端侧的刚性细长推杆/牵拉线将瓣膜从递送导管拉出，其中推进推杆背离递送导管将压缩瓣膜从递送导管拉出，或者(ii)使用可释放地连接到瓣膜的近端侧的刚性细长推杆将瓣膜从递送导管推出，其中将推杆从递送导管推出会将压缩瓣膜从递送导管推出。
递送方法还可包括如下另外的步骤：将附接到瓣膜的一个或多个组织锚定件锚定到天然组织中。
递送方法还可包括如下另外的步骤：将心脏瓣膜假体的远端锚定突片定位到右心室的右心室流出道中。
递送方法还可包括如下另外的步骤：将心脏瓣膜假体的远端锚定突片定位到右心室的右心室流出道中，并且将上部远端锚定突片定位到超环形位置中，并且上部远端锚定突片沿心室方向提供超环形向下力并且远端锚定突片沿心房方向提供子环形向上力。
递送方法还可包括如下另外的步骤：使用可转向导管沿着平行于瓣膜环平面的轴线旋转心脏瓣膜假体。
示例性-装载方法
在本发明的另一优选实施方案中，提供一种用于将可植入人工心脏瓣膜正交地装载到递送导管中的方法，所述方法包括以下步骤：将可植入人工心脏瓣膜装载到附接到递送导管的锥形夹具或漏斗中，其中瓣膜包括环形支撑框架，所述环形支撑框架具有：流量控制部件，所述流量控制部件安装在环形支撑框架内并且被构造来允许沿第一方向通过瓣膜的流入端部的血流并且阻止沿与第一方向相反的第二方向通过瓣膜的流出端部的血流；远端锚定突片，所述远端锚定突片安装在环形支撑框架的远端侧上；以及近端锚定突片，所述近端锚定突片安装在环形支撑框架的近端侧上，其中所述装载垂直或基本上正交于第一方向，其中瓣膜可压缩为压缩构型以用于使用递送导管引入到体内以便植入体内的期望位置处，所述压缩构型所具有的长x轴取向成与第一方向成介于45-135度之间的相交角，并且所述压缩构型可扩张为所具有的长x轴取向成与第一方向成介于45-135度之间的相交角的扩张构型，其中瓣膜的压缩构型的长x轴基本上平行于递送导管的纵向圆柱轴线，其中瓣膜具有约5-60mm的高度和约25-80mm的直径。
示例性-装载方法
在本发明的另一优选实施方案中，提供一种装载方法，其中装载步骤包括将装载附件附接到瓣膜侧壁、瓣膜套囊、远端锚定突片、近端锚定突片或它们的组合，其中装载附件是推杆或拉线，并且其中锥形夹具或漏斗在锥形夹具或漏斗的内表面上具有压缩元件，以有利于未压缩瓣膜的压缩、回弹(iris-ing)或螺旋移动。
示例性-用于改进流动的方法
在本发明的另一优选实施方案中，提供一种用于在植入经导管人工心脏瓣膜期间改进血液动力学流动的方法，其包括：将递送导管推进到体内的期望位置并且将权利要求1所述的瓣膜递送到体内的期望位置；从递送导管部分地释放瓣膜以围绕部分地释放的瓣膜建立血流并且建立通过流量控制部件的血流；从递送导管完全地释放瓣膜，同时用定位导管或线保持附接到瓣膜，以转变成通过流量控制部件具有增加血流并且围绕瓣膜具有减少血流；以及将瓣膜部署到最终安装位置中以转变成通过流量控制部件具有完全血流并且围绕瓣膜具有最少血流或无血流并且从瓣膜断开和撤回定位导管或线。
在本发明的另一优选实施方案中，提供一种用于改进流动的方法，其中远端锚定突片是在从部分释放瓣膜转变到完全释放瓣膜期间定位在RVOT中的RVOT突片。
示例性-制造过程
在一个优选实施方案中，本发明包括一种用于制造正交递送的经导管人工心脏瓣膜框架的方法，其包括：
(i)使用增材或减材金属或金属合金制造来生产
自扩张环形支撑框架，
其中增材金属或金属合金制造是3D打印或直接金属激光烧结(粉末熔化)，并且其中减材金属或金属合金制造是光刻、激光烧结/切割、CNC机加工、放电机加工。
在另一优选实施方案中，提供一种用于制造正交递送的经导管人工心脏瓣膜框架的方法，其还包括以下步骤：(ii)在瓣膜框架内安装流量控制部件，所述流量控制部件被构造来允许沿着中心竖直轴线通过流量控制部件的流入端部的血流并且阻止通过瓣膜的流出端部的血流；(iii)用心包材料或类似生物相容性材料覆盖瓣膜框架的外表面。
实例-压缩方法
在另一优选实施方案中，提供一种压缩方法，其中可植入人工心脏瓣膜使用选自由以下组成的组的步骤卷成或折叠成压缩构型：
(i)从环形支撑框架的一侧单侧地卷成压缩构型；
(ii)从环形支撑框架的两个相对侧两侧地卷成压缩构型；
(iii)将环形支撑框架扁平化成基本上平行于长轴的两个平行面板，并且然后将扁平化的环形支撑框架卷成压缩构型；以及
(iv)沿着竖直轴线扁平化环形支撑框架以减小瓣膜的从顶部到底部的竖直尺寸。
实例-递送
附图
现在参考附图，图1是根据本发明的正交可递送经导管心脏瓣膜100的侧透视图的图示，所述瓣膜100具有安装在环形外支撑框架104内的内反流控制部件135、安装在环形外支撑框架104内的可塌缩流量控制部件130、远端突片268以及近端突片270。
内反流控制部件135由组织覆盖件141、加强环143、不透射线标记物144和鼓/反流通道135组成。
可塌缩(内)流量控制部件130具有小叶框架231，所述小叶框架231上安装有2-4个柔性小叶258，小叶框架231可沿着z轴109从圆柱形构型折叠为扁平圆柱体构型并且可沿着竖直轴线108(y轴)压缩为缩短构型。
环形外支撑框架104由诸如镍钛合金(例如，NiTiNOL)的形状记忆材料制成，并且因此是从压缩构型开始的自扩张结构。环形(外)支撑框架104具有在处于扩张构型时外接中心竖直轴108的中心(内部)通道104和外周边壁106，并且所述环形外支撑框架104具有远端侧118和近端侧114。
流量控制部件130安装在环形外支撑框架104内，并且被构造来允许沿第一方向(例如，心房到心室)通过瓣膜100的流入端部132的血流并且阻止血液沿与第一方向相反的第二方向通过瓣膜100的流出端部134的血流。
内反流控制部件135像内流量控制部件130和外环形框架104一样是可折叠且可压缩的。内流量控制部件130包括小叶框架231，在小叶框架231上安装有2-4个柔性小叶258。
像外框架104一样，流量控制部件130并且因此小叶框架231可沿着z轴(从前向后)从圆柱形构型折叠成扁平圆柱体构型，其中折叠线位于远端侧上和近端侧上，使小叶框架231脱离环或圆柱体形状，并且将其从环扁平化成双层带，即，折叠在自身之上，或者像圆柱体一样扁平化成沿着两个相反侧连结在一起的矩形或正方形。这允许外框架104和流量控制部件130减小沿着z轴的半径，直到侧壁接触或接近接触为止。这也允许外框架104和流量控制部件130保持沿着水平轴线、y轴的半径，以使构成外框架和内框架的线单元的数量最小化，这些线单元被在装载到递送导管中所需的折叠和/或压缩期间施加的力损坏。
内反流控制部件135、流量控制部件130、小叶框架231和外框架104也是竖直地(y轴)可压缩的，从而降低整个瓣膜结构的高度以配合在递送导管138(此图中未示出)的内径内。通过沿z轴折叠并且沿y轴竖直地压缩，允许瓣膜结构沿着水平轴线或x轴保持非常大的尺寸。例如，60mm或更大直径的瓣膜可经由经导管技术递送。瓣膜的长轴线的长度(例如，60mm)由于所述长轴线平行于递送导管的中心轴线延续而不受这种大瓣膜所需的大量线框架和覆盖材料的限制。这对于现有中心轴线递送(轴向)经导管瓣膜是不可能的。与传统轴向递送瓣膜正交的折叠压缩瓣膜的使用允许以前不可用的治疗选项。
图1还示出安装在环形外支撑框架102的远端侧118上的远端锚定突片268和安装在环形外支撑框架102的近端侧114上的近端锚定突片270。
在优选实施方案中，当处于扩张构型时，瓣膜的水平x轴与中心竖直y轴成介于45-135度之间的相交角。
在优选实施方案中，瓣膜的压缩构型的水平x轴基本上平行于递送导管的纵向圆柱轴线。
在另一优选实施方案中，瓣膜具有约5-60mm的高度和约25-80mm的直径。
图1还示出引导线护套310和引导线311。管腔或引导球266被示出为安装在远端突片268的远端端部上并且引导线311螺纹穿过管腔266。虽然管腔266的内径足够大以允许引导线311延伸通过，但管腔266的内径不够大以允许护套310延伸通过。这使得护套310沿着引导线311推进直到它向上抵靠住管腔266的近端侧为止，其中在护套310上持续施加推力推靠管腔，并且允许瓣膜由远端突片从递送导管拉出，并且到达用于部署瓣膜的目标位置。
图2是具有内反流鼓137的实施方案的分解图的侧透视图的图示，所述内反流鼓137具有标记物144、通道135和环143。图2还示出根据本发明的三个小叶258尖瓣或囊袋，所述三个小叶258尖瓣或囊袋安装在具有远端折叠区域120和近端折叠区域116的可折叠且可压缩内线框架231内，内线框架231安装在外线框架102内，所述外线框架102具有周向地附接在外线框架104的顶部边缘107处的套环部件103、具有远端(rvot)突片268和近端突片270的双突片部件以及具有生物相容性材料的任选的网格部件，所述任选的网格部件可用于覆盖内反流鼓137，覆盖套环103、覆盖外框架102的内面和外面和/或覆盖锚定突片268和270。
心房套环103被成型为与天然部署位置相符。在三尖瓣置换术中，心房套环将具有高后壁部分以与天然瓣膜的中隔区域相符，并且将具有远端套环部分和近端上部套环部分。远端套环部分可大于近端上部套环部分，以考虑(心房)右心室流出道(RVOT)子环形区域上方的较大扁平空间。
图3是正交可递送经导管心脏瓣膜100的侧透视图的图示，所述瓣膜100具有带有不透射线标记物144的开放反流框架139。在此实施方案中，通道可具有预定内径，这取决于医生期望的反流等级。
图3还示出安装在环形外支撑框架102内的可塌缩流量控制部件130，可塌缩(内)流量控制部件130具有小叶框架231，所述小叶框架231上安装有2-4个柔性小叶258。小叶框架231可沿着z轴从圆柱形构型折叠为扁平圆柱体构型，并且可沿着竖直轴线(y轴)压缩为缩短构型。根据本发明，瓣膜100还具有超弹性线圈远端突片268/269和超弹性线圈近端突片270/271。
图4是具有开放反流框架139的实施方案的分解图的侧透视图的图示，所述开放反流框架139具有不透射线标记物144。图4还示出根据本发明的安装在可折叠且可压缩内线框架231内的三个小叶尖瓣或囊袋258，内线框231安装在外线框102内，所述外线框102具有周向地附接在外线框102的顶部边缘107处的套环部件103、一对整合式独立突片部件269、270和网格部件226。
未经覆盖的反流框架139提供瓣膜的受控反流。一旦患者不再需要反流，未经覆盖的反流框架139稍后就可用稍后插入的支架或覆盖件或塞子塞住。
心房套环103被成型为与天然部署位置相符。在三尖瓣置换术中，心房套环将具有高后壁部分以与天然瓣膜的中隔区域相符，并且将具有远端套环部分和近端上部套环部分。远端套环部分可大于近端上部套环部分，以考虑(心房)右心室流出道(RVOT)子环形区域上方的较大扁平空间。
整体式突片269和271与外框架的主体是一体式构造。突片的大小和形状可不同。在优选实施方案中，RVOT突片(例如，269)可更长以到达肺动脉的入口中(在三尖瓣置换术的情况下)。
图5是根据本发明的(当从较宽侧观察时从前向后)沿着z轴处于折叠构型的正交可递送经导管心脏瓣膜100的侧透视图的图示。图5示出具有折叠/扁平套环103、铰链点116、120的折叠(扁平)外框架102。图5还示出具有标记物144的折叠/扁平内反流控制部件137和安装在折叠/扁平内框架231内的小叶258。
图6是根据本发明的处于竖直地压缩构型的正交可递送经导管心脏瓣膜100的侧透视图的图示。图6示出具有沿着铰接点116、12o之间的折叠线折叠(z轴)和竖直地压缩(y轴)的套环103的折叠(z轴)和竖直地压缩(y轴)的外框架102。图6还示出内反流控制部件137和安装在内框架231内的小叶258。
图7是根据本发明的部分地装载到递送导管138中的正交可递送经导管心脏瓣膜100的侧透视图的图示。图7示出外框架102、折叠套环103、内反流控制部件137和具有小叶258和内框架231的流量控制部件130。
图8是根据本发明的示出所装载瓣膜100的递送导管138的端视图的图示，其中外框架102和套环103可见。
图9是在安置在天然环中之前从递送导管138排出从而处于部分位置的折叠的压缩瓣膜的顶视图的图示，所述部分位置允许小叶258、套环103和内框架231扩张。
图10是不具有套环的瓣膜的顶部透视图的图示，其中移除内反流控制部件137以供观察，且示出组织141、加强环143和通道135。图10还示出根据本发明的具有网格侧壁覆盖件226、内框架231和缝合到内框架231中的小叶258的外圆柱体框架102。
图11是根据本发明的不具有套环的瓣膜的顶部透视图的图示，所述瓣膜具有标记物144和安装在外圆柱体框架102的顶部边缘107上的内反流控制部件137，外框架102还具有网格侧壁覆盖件226、内框架231和缝合到内框架231中的小叶258。
图12是根据本发明的不具有套环的瓣膜的底部透视图的图示，所述瓣膜具有安装在外圆柱体框架102的顶部边缘107上的内反流控制部件137，外框架102还具有网格侧壁覆盖件226、内框架231和缝合到内框架231中的小叶258。
图13是不具有套环的瓣膜的分解图的图示，所述瓣膜具有内反流控制部件137，所述内反流控制部件137包括组织覆盖件141和反流框架139。图13还示出根据本发明的外圆柱体框架102，外框架102具有网格侧壁覆盖件226、内框架231和安装在带257上并缝合到内框架231中的小叶258。
图14是根据本发明的处于圆柱体构型的内小叶框架231(或反流框架139)的顶部透视图的图示，这作为允许折叠和压缩内框架的过程的开始示出。
图15是根据本发明的处于部分地折叠构型的内小叶框架231(或反流框架139)的顶部透视图的图示，其中线框架侧壁在其侧向连接点116、120处旋转或铰接，这作为允许折叠和压缩内框架的过程的部分第一步骤示出。
图16是根据本发明的处于完全折叠构型208的内小叶框架231(或反流框架139)的侧视图的图示，其中线框架侧壁在其侧向连接点处旋转或铰接，这作为允许折叠和压缩内框架231的过程的完成第一步骤示出。
图17是根据本发明的处于折叠和竖直地压缩构型210的内小叶框架231(或反流框架139)的侧视图的图示，其中线框架侧壁以打褶或手风琴式折叠构型竖直地压缩，这作为允许折叠和压缩内框架的过程的第二步骤示出。
图18是根据本发明的在进一步组装成圆柱体结构之前作为线性线框架板材202的内小叶框架231(或反流框架139)的侧视图的图示。
图19是根据本发明的处于圆柱体或圆柱状(锥形等)构型的内小叶框架231的侧透视图的图示。
图20是根据本发明的心包组织带257的侧透视图的图示，所述带257以圆柱体形状被构造成具有缝合到结构带257中的小叶囊袋258。
图21是根据本发明的在组装成圆柱形小叶部件并安装在内框架上以形成可塌缩(可折叠、可压缩)流量控制部件之前具有缝合到结构带257中的小叶囊袋的心包组织带257的侧视图的图示。
图22是根据本发明的在组装成圆柱形小叶部件并安装在内框架上以形成可塌缩(可折叠、可压缩)流量控制部件之前具有缝合到结构带257中的小叶囊袋258的心包组织带257的底部视图的图示。
图23是根据本发明的具有缝合到结构带中的单个小叶囊袋的心包组织带的一部分的侧透视图的图示，示出小叶囊袋258与延伸出的开放边缘261和作为提供附接的闭合顶部抛物线边缘的缝合边缘259部分接合。
图24是根据本发明的示出完全接合以形成闭合流体密封件的圆柱形小叶部件258的底部视图的图示。
图25(a)至图25(e)是过程的图示，其中将具有预穿孔鼓内的瓣膜正交地递送在导管内、从导管排出并部署到天然环中。图25(a)示出位于递送导管内并且沿着引导线移动穿过天然环的压缩和折叠正交瓣膜。图25(b)示出正交被部分地排出到天然环中，其中递送导管能够根据需要扭转或定位瓣膜。图25(c)示出完全排出瓣膜，其中rvot突片以子环形方式延伸以帮助锚定瓣膜，并且瓣膜以一定角度向上保持以允许实施/开始洗涤和接合。图25(d)是示出位于不透射线标记物的周边内的预穿孔鼓和反流通道的顶视图。图25(e)是侧透视图并且示出位于不透射线标记物的周边内的预穿孔鼓和反流通道，内反流控制部件在外支撑框架内邻近内流量控制部件(小叶和框架)安装。
图26是外线框架102的图示。
图27是根据本发明的具有部分地折叠构型的外线框架102的顶部透视图的图示，其中侧壁在其侧向连接点116、120处旋转或铰接，这作为允许折叠和压缩外框架102的过程的部分第一步骤示出。
图28是根据本发明的处于完全平折构型208的外框架102的侧视图的图示，其中线框架侧壁在其侧向连接点116、120处旋转或铰接，这作为允许折叠和压缩外框架102的过程的完成第一步骤示出。
图29是根据本发明的处于折叠和竖直地压缩构型210的外框架102的侧视图的图示，其中线框架侧壁以打褶或手风琴式折叠构型竖直地压缩，这作为允许折叠和压缩外框架102的过程的第二步骤示出。
图30是根据本发明的组装后瓣膜的顶部透视图的图示，所述组装后瓣膜具有带有标记物和加强环的内反流控制部件137、外框架102、具有内小叶框架231和三个缝合小叶囊袋/尖瓣258的流量控制部件130、内间隔框架137以及位于间隔框架上方的网格覆盖件141，折叠线109被示出为虚线。
图31是根据本发明的组装后瓣膜的顶部透视图的图示，所述组装后瓣膜具有带有标记物的内反流控制部件137、外框架102、邻近流量控制部件130安装在外框架102上的第一子环形锚定/定位突片268、安装在外框架上不同位置的第二子环形锚定/定位突片270、具有内小叶框架231和三个缝合小叶囊袋/尖瓣258的流量控制部件130、内间隔框架137以及位于间隔框架上方的网格覆盖件141，折叠线109被示出为虚线并且横穿网格覆盖件。
图32是根据本发明的组装后瓣膜的底部透视图的图示，所述组装后瓣膜具有外框架102、邻近流量控制部件130安装在外框架102上的第一子环形锚定/定位突片268、安装在外框架102上不同位置的第二子环形锚定/定位突片270、具有内小叶框架231和三个缝合小叶囊袋/尖瓣258的流量控制部件130、内间隔框架137以及位于间隔框架上方的网格覆盖件141，折叠线109被示出为虚线，并且血液动力学洗涤腔被示出为在所覆盖内间隔框架下方。
图33是根据本发明的组装后瓣膜的顶视图的图示，所述组装后瓣膜具有内反流控制部件137、外框架102、具有内小叶框架231和三个缝合小叶囊袋/尖瓣258的流量控制部件130、内间隔框架137以及位于间隔框架上方的网格覆盖件141。
图34是根据本发明的组装后瓣膜的顶部透视图的图示，所述组装后瓣膜具有加强环的内反流控制部件137、外框架102、邻近流量控制部件130安装在外框架102上的第一子环形锚定/定位突片268、安装在外框架102上不同位置的第二子环形锚定/定位突片270、具有内小叶框架231和三个缝合小叶囊袋/尖瓣258的流量控制部件130、内间隔框架137以及位于间隔框架上方的网格覆盖件141。
图35(a)至图35(e)是逐步过程的图示，其中在将瓣膜正交地装载到递送导管中之前对组织鼓进行穿孔。步骤(a)示出提供如本文所述的正交人工瓣膜(可折叠、可压缩用于侧向递送，具有rvot突片、引导线管腔、心房套环和近端突片)的步骤。步骤(b)示出通过切割或使用球囊装置产生开口的步骤。步骤(c)示出将瓣膜平折以准备装载到递送导管中的步骤。步骤(d)示出竖直地压缩瓣膜以准备将瓣膜装载到递送导管中的步骤。步骤(e)示出将正交瓣膜侧向地装载到递送导管中的步骤。
图36(a)至图36(c)是逐步过程的图示，其中在将瓣膜从递送导管正交地排出并部署到天然环中之后对组织鼓进行穿孔。步骤(a)示出将瓣膜排出到天然环中，从而以略微升高的角度水平地接近以将rvot突片定位到通向右(肺)瓣膜流出道的子环形空间中的步骤。步骤(b)示出使用荧光透视检查定位不透射线标记物的步骤。步骤(c)示出通过切割或使用球囊装置产生开口的步骤。
图37是用户可如何使孔口的大小与期望的反流量(例如，0.5-2.0范围内的反流等级)匹配的图示。不透射线标记可用于辅助测量要作出的穿孔的大小。
图38是用户可如何与管状支架的管腔的大小匹配的图示，所述管腔可部署到孔口中以与期望的反流量(例如，0.5-2.0范围内的反流等级)匹配。
图39是根据本发明的带标签瓣膜100的侧中隔平面图的图示，所述带标签瓣膜具有朝向远端侧延伸的子环形锚定和/或定位突片268和向近端侧延伸的第二子环形突片270并且具有可见的可折叠且可压缩线框架构造，包括内框架231、小叶258和内反流控制部件137。
图40(a)至图40(f)是用于闭合内反流控制部件中的穿孔的闭合装置的图示。步骤(a)示出提供如本文所述的正交人工瓣膜(可折叠、可压缩用于侧向递送，具有rvot突片、引导线管腔、心房套环和近端突片)的步骤，所述正交人工瓣膜具有需要密封的内反流控制部件137。步骤(b)示出使用导管工具进入穿孔的步骤。步骤(c)示出在穿孔的远端下侧上扩张第一碟或按钮的步骤。步骤(d)示出在穿孔的近端顶侧上扩张第二碟或按钮的步骤。步骤(e)示出将两个碟/按钮收紧在一起，从而产生密封件以阻挡工程化在例如1-2mm穿孔中的反流的步骤。步骤(f)示出抽回导管工具的步骤。
图41是部分地从递送导管138排出的瓣膜的顶视图的图示，其中远端突片268将瓣膜(沿着未示出的引导线)引向部署位置，远端流量控制部件130开始打开，并且示出三个小叶258中的两个从折叠平展构型打开并且第三小叶从折叠构型打开，在折叠构型中，第三小叶在处于递送导管138中时往回折叠在自身上。
图42是压缩136(正交地装载)于递送导管138内的瓣膜的顶视图的图示，所述瓣膜具有外框架102，外框架102具有沿着x轴向前延伸的第一突片268和沿着x轴向后延伸的第二后缘突片270。
图43是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架102、偏心内流量控制部件130(小叶在框架中)和不规则形状的间隔框架/支撑框架137。
图44是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架102、居中地定位的内流量控制部件130(小叶在框架中)和位于内流量控制部件130的相反侧上的一对不规则形状的间隔框架/支撑框架135、137。
图45是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有外框架102和内流量控制部件130(小叶在框架中)和多个缝合附接点129，其中内流量控制部件130被缝合到外框架102。
图46是具有内反流控制部件137的瓣膜的顶视图，其中起搏器和引线组145延伸穿过穿孔。图46还示出根据本发明的外框架102、具有框架231和小叶258的偏心内流量控制部件130和内间隔框架137，所有三个结构都可沿着同一x轴109折叠。
图47是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有内反流控制部件137、外框架102、具有框架231和小叶258的居中地定位的内流量控制部件130以及安装在内流量控制部件231的相反侧上以在外框架102的内部尺寸内提供支撑的一对较小圆柱形内反流控制部件137、147，所有四个结构都可沿着同一x轴109折叠。在此，内反流控制部件137具有紧邻主流量控制部件安装的三小叶微型瓣膜，并且第二内反流控制部件/鼓147具有未穿孔组织覆盖件，其稍后可向医师提供根据需要增加另外的反流的机会。
图48是根据本发明的瓣膜的顶视图的图示，所述瓣膜具有远端侧内反流控制部件137、外框架102、具有框架231和小叶258的近端地定位的偏心内流量控制部件130，所有三个结构都可沿同一x轴109折叠。
图49是根据本发明的人类心脏的侧视图的图示，所述人类心脏具有从右心房横穿到左心房以进入二尖瓣膜的经股骨/IVC或SVC递送导管138。图49示出正交递送步骤：
1.提供可折叠、可压缩人工三尖瓣膜；
2.将瓣膜侧向地装载到递送导管中；
3.将瓣膜在螺纹连接到子环形远端突片上的预置引导线之上经由IVC或SVC推进到心脏；
4.部分地排出瓣膜以定位远端子环形突片并且允许瓣膜小叶开始起作用；
5.完成瓣膜到天然环中的部署。
6.任选地：如果反流鼓在装载到递送导管中之前并未打开，则可推进切割工具或球囊工具，并且在鼓框架的组织覆盖物中形成1-2mm开口。
7.任选地：可将起搏器导线组推进穿过反流鼓中的开口并且将一根或多根起搏器线附接在目标节点处或附近。
另外的定义和零件列表
下文提供了与要求保护的元件相关的零件列表。零件编号可是指功能部件并且可在不同的优选实施方案中重复使用以辅助统一理解结构-功能关系。为了避免图片中出现混乱，并非每个数字都可添加到图片。
100 双突片正交递送的经导管人工心脏瓣膜。
102 自扩张环形(外)支撑框架。
103 套环结构。
104 中心通道。
106 外周边壁。
107 外支撑框架的顶部边缘。
108 中心竖直轴线。
109 Z轴，从前向后，折叠线轴线。
110 周边壁的前壁部分。
112 周边壁的后壁部分。
114 近端侧。
116 近端折叠区域。
117 辅助近端折叠区域。
118 远端侧。
120 远端折叠区域。
121 辅助远端折叠区域。
122 前上部套环部分。
124 外框架的前下部主体部分。
126 后上部套环部分。
128 后下部主体部分。
129 用于由内向外的缝合附接点。
130 流量控制部件，由具有安装在其中的组织小叶的内框架制成，可塌缩的(可折叠且可压缩)，内框架安装在环形外支撑框架内并且被构造来允许沿第一方向通过流入端部的血流并且阻止沿相反的第二方向通过流出端部的血流。
132 流入端部。
134 流出端部。
135 鼓通道。
136 压缩构型
137 内反流控制部件。
138 递送导管。
139 未覆盖的反流框架，工程化(治疗)部分反流
140 X轴，水平轴线，平行于递送导管中心轴线
141 组织覆盖件(塑性变形)。
142 相交角45-135度，X轴与Y轴。
143 加强环。
144 不透射线标记物。
146 递送导管的纵向圆柱轴线。
148 约5-60mm的高度。
150 约25-80mm的直径。
202 多个可压缩线单元-外框架。
204 取向和单元几何结构，基本上正交于中心竖直轴线以在压缩环形支撑框架时最小化线单元应变。
206 竖直压缩构型。
208 折叠构型。
210 折叠和压缩构型。
212 内框架形状或外框架形状，选自漏斗、圆柱体、扁平锥体或圆形双曲面。
220 编织基质。
222 线框架基质。
224 激光切割线框架。
226 生物相容性材料。
227 内框架上的喇叭形套囊。
228 内框架的侧轮廓为扁平锥体形状。
229 非圆柱形内框架，例如，椭圆形截面。
230 40-80mm的直径R。
231 内框架，用于安装小叶。
232 20-60mm的直径r。
233 内框架的均匀线框架单元组。
234 5-60mm的高度。
235 内框架的非均匀可变高度单元。
236 环形外支撑框架的内部表面。
237 非均匀单元几何结构，线框架大小。
238 环形外支撑框架的外部表面。
239 压缩内框架。
240 心包组织，用于覆盖瓣膜表面。
241 菱形或眼睛状线单元。
242 编织合成聚酯材料。
243 内线框上的孔眼，一致的连合附接。
244 具有沙漏形状的外支撑框架。
245 内框架上的激光切割附接特征件。
246 40-80mm的顶部直径R1。
248 50-70mm的底部直径R2。
250 20-60mm的内径。
252 5-60mm的高度。
254 20-60mm的内径。
256 10-40mm的高度。
257 小叶带，用于小叶囊袋的安装带。
258 小叶、多个小叶、心包材料。
259 小叶的缝合边缘。
260 流入端部处的圆的圆柱。
261 小叶的开放边缘
262 流出端部处的扁平可闭合孔口。
264 流量控制部件中/上的纵向支撑件，选自刚性或半刚性柱、刚性或半刚性肋、刚性或半刚性棒、刚性或半刚性面板以及它们的组合。
266 远端突片上的(任何)管腔(球)。
268 远端突片/子环形锚定突片，可为rvot或其他，由线圈或线框、整合式框架部段或支架构成，背离环形支撑框架延伸约10-40mm。
269 独立RVOT突片。
270 近端突片/子环形锚定突片。
271 独立近端突片。
272 环形支撑框架的远端上部边缘。
273 上部心房张力臂，由线圈或线框架构成，背离环形支撑架延伸约2-20mm。
274 下部张力臂，由线圈或线框、整合式框架部段或支架构成，背离环形支撑框架延伸约10-40mm。
276 环形支撑框架的远端侧。
278 组织锚定件，连接到环形支撑框架以用于接合天然组织。
280 框架的前壁部分是第一扁平面板。
282 框架的后壁部分是第二扁平面板。
284 缝合接缝。
285 铰链。
286 柔性织物跨度，无任何金属线单元。
287 织物面板。
288 编织线单元。
289 连合附接-小叶到框架。
290 激光切割线单元。
302 卷成压缩构型。
304 两侧地卷成压缩构型。
306 使环形支撑框架面板扁平化。
308 压缩环形支撑架，从顶部到底部。
310 护套/刚性细长推杆/牵拉线。
311 引导线。
312 可转向导管，用于沿着平行于瓣膜环平面的轴线旋转心脏瓣膜假体，其中安装在瓣膜上的上部张力臂构象地压力锁定在环上组织上，并且其中安装在瓣膜上的下部张力臂构象地压力锁定在子环形组织上。
可将各种上文公开的和其他特征和功能或者它们的替代方案组合到许多其他不同的系统或应用中。本领域技术人员随后可做出本文中目前未可预见或未预料到的各种替代方案、修改、变型或改进，而这些中的每一种也旨在由所公开的实施方案所涵盖。
已经在本文中描述了本发明的实施方案，应注意，本领域技术人员可根据上述教导内容作出修改和变型。因此，应当理解，可在所公开的本发明的特定实施方案中做出改变，这些改变在如由所附权利要求限定的本发明的范围和精神内。因此，已经根据专利法要求的细节和特殊性描述了本发明，在所附权利要求中阐述了受专利特许证要求保护和期望保护的内容。

Claims (11)

1.一种用于在正交递送的经导管人工心脏瓣膜内管理和提供有意反流等级的装置，其包括：
正交递送的经导管人工心脏瓣膜，所述正交递送的经导管人工心脏瓣膜具有第一内流量控制部件、第二内反流控制部件和外环形支撑框架，
所述第二内反流控制部件具有可折叠且可压缩框架、附接到所述框架的组织覆盖件以及安装在加强环内的流量调节器，所述加强环安装在所述组织覆盖件上，所述流量调节器选自通道、封堵器、管状支架以及在其管腔内具有封堵器的管状支架，所述组织覆盖件具有一个或多个不透射线标记物，并且所述第二内反流控制部件安装在所述人工心脏瓣膜的所述外支撑框架内，
所述自扩张环形外支撑框架具有中心通道、在扩张构型中外接中心竖直轴线的外周边壁、沿着所述周边壁的顶部边缘安装的心房套环、安装在所述外环形支撑框架的远端侧上的远端锚定突片以及安装在所述外环形支撑框架的近端侧上的近端锚定突片，
所述第一内流量控制部件在所述外环形支撑框架内邻近于所述第二内反流控制部件安装，所述第一内流量控制部件被构造来允许沿第一方向通过所述瓣膜的流入端部的血流并且阻止沿与所述第一方向相反的第二方向通过所述瓣膜的流出端部的血流，所述第一内流量控制部件具有小叶框架，所述小叶框架上安装有2-4个柔性小叶，
其中所述第二内反流控制部件的所述可折叠且可压缩框架、所述第一内流量控制部件的所述小叶框架和所述外支撑框架中的每一者各自能够沿着水平z轴从圆柱形构型折叠为扁平圆柱体构型并且能够沿着竖直y轴压缩为缩短构型，
其中所述人工心脏瓣膜能够压缩为压缩构型以用于使用递送导管引入到体内以便植入在所述体内的期望位置处，所述压缩构型沿着基本上平行于所述递送导管的纵向圆柱轴线的水平x轴取向，所述水平x轴取向成与所述中心竖直y轴成介于45-135度之间的相交角，并且所述压缩构型能够扩张为使所述水平x轴与所述中心竖直y轴成介于45-135度之间的相交角的扩张构型，
其中所述瓣膜具有约5-60mm的高度和约25-80mm的直径。
2.如权利要求1所述的瓣膜，其中所述环形外支撑框架具有内表面和外表面，所述内表面和所述外表面覆盖有生物相容性材料，选自由以下组成的项：所述内表面覆盖有心包组织，所述外表面覆盖有织造合成聚酯材料，以及所述内表面覆盖有心包组织和所述外表面覆盖有织造合成聚酯材料两者。
3.如权利要求1所述的瓣膜，其中所述远端锚定突片、所述近端锚定突片或两者由线圈、线框架、激光切割框架、整合式框架部段或支架组成，并且背离所述环形外支撑框架的侧面延伸约10-40mm。
4.如权利要求1所述的瓣膜，其还包括：上部远端锚定突片，所述上部远端锚定突片附接到所述环形支撑框架的远端上部边缘，所述上部远端锚定突片由线圈、线框架、激光切割框架、整合式框架部段或支架组成，并且背离所述环形外支撑框架延伸约2-20mm。
5.如权利要求1所述的瓣膜，其包括：至少一个组织锚定件，所述至少一个组织锚定件连接到所述环形外支撑框架以用于接合天然组织。
6.如权利要求1所述的瓣膜，其中所述环形外支撑框架由可压缩线单元组成，所述可压缩线单元选自由以下组成的组：编织线单元、激光切割线单元、光刻产生的线单元、3D打印线单元、由呈波浪形状、之字形状或螺旋形状的间歇地连接的单股线形成的线单元或它们的组合。
7.如权利要求1所述的瓣膜，其中所述环形外支撑框架在外表面上覆盖有心包组织、聚酯材料或类似的生物相容性材料。
8.一种在植入式经导管人工心脏瓣膜中提供有意反流的方法，其包括以下步骤：
通过将导管切割工具部署到如权利要求1所述的植入式瓣膜来对如权利要求1所述的第二内反流控制部件的所述组织覆盖件进行切割或穿孔以形成孔口，其中如权利要求1所述的瓣膜作为人工心脏瓣膜植入患者体内。
9.如权利要求8所述的方法，其包括另外的步骤：将流量调节器部署到所述孔口中，所述流量调节器选自封堵器、管状支架以及其管腔内具有封堵器的管状支架。
10.一种控制或调节具有正交递送的经导管人工心脏瓣膜的患者体内的反流的方法，其包括以下步骤：
步骤1.提供根据权利要求1所述的可折叠、可压缩人工三尖瓣膜；
步骤2.将所述瓣膜侧向地装载到递送导管中；
步骤3.将所述瓣膜在螺纹连接到子环形远端突片上的预置引导线之上经由下腔静脉(IVC)或上腔静脉(SVC)推进到所述患者的心脏的三尖瓣膜；
步骤4.部分地排出所述瓣膜以定位所述远端子环形突片并且允许瓣膜小叶开始起作用；
步骤5.完成所述瓣膜到所述天然环中的部署；以及
步骤6.将切割工具或球囊工具通过所述递送导管推进到所部署瓣膜并且在所述内反流控制部件的所述组织覆盖物中产生1-5mm开口。
11.如权利要求10所述的方法，其还包括：
步骤7.将起搏器线组推进通过所述内反流控制部件的所述组织覆盖物中的所述开口并且将一根或多根起搏器线附接在目标传导节点处或附近。
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EP3934583A2 (en) 2022-01-12
EP3934583A4 (en) 2022-11-23
US20210315694A1 (en) 2021-10-14
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WO2020181154A3 (en) 2020-11-12
AU2020231221A1 (en) 2021-09-23

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