CN114072106A - 用于在自体瓣环中部署侧面递送的假体心脏瓣膜的束紧装置和方法 - Google Patents

用于在自体瓣环中部署侧面递送的假体心脏瓣膜的束紧装置和方法 Download PDF

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CN114072106A
CN114072106A CN202080036597.9A CN202080036597A CN114072106A CN 114072106 A CN114072106 A CN 114072106A CN 202080036597 A CN202080036597 A CN 202080036597A CN 114072106 A CN114072106 A CN 114072106A
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valve
support frame
annulus
distal
tether
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R·维德伦德
M·克里斯蒂安松
D·霍尔特
L·哈尔德
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Vidine Co ltd
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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
    • 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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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

Abstract

本发明涉及锚固通道和瓣环下方锚固件，其用于经导管心脏瓣膜置换(A61F2/2412)，并且特别地用于具有瓣环支撑框架的正交递送的经导管假体心脏瓣膜，所述瓣环支撑框架具有可压缩线材单元，所述可压缩线材单元便于沿纵向或正交于流动控制部件的中心轴线卷起和折叠所述瓣膜，从而允许将非常大直径的瓣膜从下腔静脉或上腔静脉递送和部署到三尖瓣，或者经心房递送和部署到二尖瓣，所述瓣膜具有约5mm‑60mm的高度和约25mm‑80mm的直径，而不需要过大直径的导管并且不需要以锐角接近角度从导管递送和部署。

Description

用于在自体瓣环中部署侧面递送的假体心脏瓣膜的束紧装置 和方法
相关申请的交叉引用
本申请要求于2019年5月4日提交的名称为“Cinch Device and Method forDeployment of an Orthogonal Prosthetic Heart Valve in a Native Annulus”的美国临时申请序列号62/843,424的优先权和权益，其公开内容整体以引用方式并入本文。
背景技术
本文描述的实施方案涉及假体心脏瓣膜，并且具体地涉及用于在自体瓣环中部署正交假体心脏瓣膜的束紧装置和方法。
假体心脏瓣膜可能对心脏内的递送和部署，特别是对于通过导管穿过患者的脉管系统而不是通过外科途径进行的递送带来挑战。传统的经导管假体瓣膜的递送通常包括在径向方向上压缩瓣膜并将瓣膜装载到递送导管中，使得瓣膜的中心瓣环轴线平行于递送导管的纵向轴线。瓣膜从递送导管的端部部署，并且从中心瓣环轴线沿径向方向向外扩张。然而，传统瓣膜的扩张尺寸(例如，直径)可能受到递送导管的内径的限制。使递送导管尺寸最小化的冲突利益对增加传统瓣膜的扩张直径(例如，试图将过多的材料和结构压缩到过小的空间中)提出了挑战。
因此，存在对具有一个或多个部署辅助特征同时保持允许瓣膜的经导管递送的相对小的压缩尺寸的假体瓣膜的需要。
发明内容
本发明涉及一种束紧设备，该束紧设备用以在部署期间减小瓣膜的跨瓣环侧壁的周长，随后释放束紧设备以将周长扩张到全尺寸并获得用于经导管心脏瓣膜置换的自体瓣环的可靠密封，该瓣膜具有近端瓣环下方锚固接片和远端瓣环下方锚固接片，并且具体地是具有瓣环支撑框架的侧面递送(纵向)经导管假体心脏瓣膜，该瓣环支撑框架具有可压缩线材单元，该可压缩线材单元便于沿纵向或正交于流动控制部件的中心轴线在高度和/或宽度上卷起、折叠、压缩瓣膜，从而允许非常大直径的瓣膜从下腔静脉直接递送和部署到三尖瓣中，例如，具有约5mm-60mm的高度和约25mm-80mm的直径，而不需要过大直径的导管并且不需要以锐角接近角度从导管递送和部署。
附图说明
图1是根据实施方案的示意性剖面侧视图。
图2是根据实施方案的示意性底视图。
图3是根据近端系绳组件实施方案的示意性剖面侧视图。
图4是根据远端系绳组件实施方案的示意性剖面侧视图。
图5是本发明的一个实施方案的图像，其中束紧组件附接到可正交递送的瓣膜。
图6是在束紧之前的瓣膜的一个实施方案的图示，其中近侧在瓣环上方(心房)位置被阻挡，并且远侧部分地安置到瓣环环上，其中远端瓣环下方(心室)接片和远端心房套囊在瓣膜周壁中形成远端凹形周向通道。
图7是在束紧期间瓣膜的一个实施方案的图示，其中近侧被束紧或暂时向内回缩以允许瓣膜的近侧向下插入瓣膜瓣环中，使得通过将近侧硬塞(或适配)到瓣环中，近侧可被释放以将其从瓣环上方位置移动到瓣环位置，并提供抵靠瓣环环的张力配合。远侧被示出为部分地安置到瓣环环上，其中远端瓣环下方(心室)接片和远端心房套囊在瓣膜周壁中形成远端凹形周向通道。
图8是示出了在3个步骤中的步骤1时处于释放位置的束紧系统的一个非限制性实施方案的图示，由此牵拉系绳和所附接的牵拉环已经勒住束紧系绳的心房部分(在瓣膜套环上方)，同时束紧系绳穿过套环中的孔眼串在下安装元件和上安装元件之间，该下安装元件在套环下方附接到周壁，该上安装元件被示出为束紧环，该束紧环紧固到锚固的可操纵导管，其中可操纵导管穿过束紧环。
图9是示出了在3个步骤中的步骤2时处于束紧位置的束紧系统的一个非限制性实施方案的图示，由此牵拉系绳和所附接的牵拉环已经勒住并牵拉束紧系绳的心房部分(在瓣膜套环上方)，其中束紧系绳的下部部分(在套环下方)向前缩短并且将瓣膜框架周壁拉动至(主体)压缩位置，其中束紧系绳穿过套环中的孔眼串在下安装元件和上安装元件之间，该下安装元件在套环下方附接到周壁，该上安装元件被示出为束紧环，该束紧环紧固到锚固的可操纵导管，其中可操纵导管穿过束紧环。
图10是示出了在3个步骤中的步骤3时回到释放位置的束紧系统的一个非限制性实施方案的图示，由此通过将束紧/压缩的近侧周壁降低到瓣环环中并释放束紧系统以使周壁抵靠自体瓣环的近侧扩张而将瓣膜安置到自体瓣环中。
图11是示出束紧系统的一个非限制性实施方案的图示，其示出了可操纵导管被致动(旋转，旋开)以从(螺纹)接收器脱离。
图12是示出束紧系统的一个非限制性实施方案的图示，并且示出了可操纵导管被拉出束紧系绳的束紧环/孔眼，其中可操纵导管被完全抽回到递送导管中并且从患者体内抽出。
图13是示出束紧系统的一个非限制性实施方案的图示，并且示出了牵拉系绳及其环被拉出束紧系绳的束紧环/孔眼，其中牵拉系绳被完全抽回到递送导管中并且从患者体内抽出。
图14是示出束紧系统的一个非限制性实施方案的另一个图示，并且示出了可操纵导管和牵拉系绳及其环被拉出束紧系绳的束紧环/孔眼，其中可操纵导管和牵拉系绳被完全抽回到递送导管中并且从患者体内抽出。
图15是其中束紧系绳可用于被修剪掉，或留在适当位置以被纳入向内生长的组织中的部署/安置的瓣膜的图示。
图16是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤1的一个非限制性实施方案的图示，该假体心脏瓣膜具有远端锚固接片/张力臂，该远端锚固接片/张力臂被放置到远端瓣环下方位置中，其中远端周壁楔入到自体瓣环环上，折叠/收起的近端接片附接到近端接片导管，并且束紧系统安装到瓣膜上。
图17是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤2的一个非限制性实施方案的图示，并且示出了瓣膜主体的近侧(周壁)向内束紧/回缩以减小瓣膜主体的尺寸(直径、周长)，因此瓣膜可安置到自体瓣环中。
图18是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤3的一个非限制性实施方案的图示，并且示出了束紧件的释放和近端接片的部署，其中束紧系统在瓣膜主体上释放压缩力并允许瓣膜径向地扩张到自体瓣环中，并且其中近端接片导管将折叠/收起的近端接片展开远离瓣膜主体，以提供用于瓣膜的近侧锚固元件。
图19是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤4的一个非限制性实施方案的图示，其中瓣膜已经部署，并且束紧系统和近端接片导管正被抽回到递送导管中并且从患者体内抽出。
图20是示出束紧系统的一个非限制性优选扭转实施方案的2个步骤中的步骤1的图示，其中瓣膜处于扩张构型，并且可操纵导管连接到多个牵拉和束紧(组合)系绳，其中每根系绳穿过套环中的单独孔眼串起并且在瓣膜的套环下方安装到瓣膜主体壁上，其中可操纵导管的旋转使系绳向前缩短并且将瓣膜主体扭转或扭绞成较窄的径向尺寸以便于插入和定位到自体瓣环中。
图21是示出束紧系统的一个非限制性优选扭转实施方案的2个步骤中的步骤2的图示，其中瓣膜处于径向压缩构型，其中可操纵导管的旋转使系绳向前缩短，从而将瓣膜主体扭转或扭绞成较窄的径向尺寸以便于将瓣膜插入和定位到自体瓣环中。
图22是示出束紧系统的一个非限制性优选束带实施方案的2个步骤中的步骤1的图示，其中瓣膜处于扩张构型，并且可操纵导管连接到辊圆柱体，其中可束紧带环绕瓣膜主体并且在瓣膜的套环下方安装到瓣膜主体壁上，其中可操纵导管的旋转使辊圆柱体旋转并且使可束紧带向前缩短以将瓣膜主体减小到较窄的径向尺寸以便于插入和定位到自体瓣环中。
图23是示出束紧系统的一个非限制性优选可束紧带实施方案的2个步骤中的步骤2的图示，其中瓣膜处于径向压缩构型，其中可操纵导管的旋转将带的一部分卷起到辊圆柱体上，并且使带向前缩短，从而将瓣膜主体减小到较窄的径向尺寸以便于将瓣膜插入和定位到自体瓣环中。
图24是根据本发明的具有远端右心室流出道(RVOT)接片、近端接片的可正交递送的经导管心脏瓣膜的侧透视图的图示。
图25是根据本发明的单系绳束紧件的侧视图的图示，该单系绳束紧件具有套在环绕周壁的可释放系绳锁上的递送导管以及用于连接到系绳锁的锚固件可安装元件。
图26是根据本发明的双系绳束紧件的侧视图的图示，该双系绳束紧件具有套在环绕周壁的可释放系绳锁上的递送导管以及用于连接到系绳锁的锚固件可安装元件。
图27是根据本发明的双系绳束紧件的侧视图的图示，该双系绳束紧件具有套在环绕周壁的可释放系绳锁上的递送导管以及用于连接到系绳锁并且连接到折叠起来的近端接片的锚固件可安装元件。
图28是根据本发明的单系绳束紧件的侧视图的图示，该单系绳束紧件具有套在环绕周壁的可释放系绳锁上的递送导管以及用于连接到系绳锁并且连接到折叠起来的近端接片的锚固件可安装元件。
图29是处于束紧构型的瓣膜的顶视图图示。
图30是处于扩张构型的瓣膜的顶视图图示。
图31是处于双侧束紧构型(中隔和前部，均束紧)的瓣膜的顶视图图示。
图32是安装有系绳的处于双侧扩张构型(中隔和前部，均扩张)的瓣膜的顶视图图示。
图33是安装有系绳的处于双侧束紧构型(中隔和前部，均束紧)的瓣膜的顶视图图示。
图34是示出瓣膜的椭圆的长轴R1的百分比减小和计算的周长收缩的图表。
图35是示出瓣膜的椭圆的短轴r1的百分比减小和计算的周长收缩的图表。
图36是示出瓣膜的椭圆的长轴R1的百分比减小和计算的周长收缩的图表。
图37是心脏截面的顶(最低点)视图，并且示出了各种解剖特征之间的关系。
图38是瓣膜递送导管的图示，该瓣膜递送导管与束紧设备导管一起工作以将瓣膜递送到自体瓣环，然后释放/松开瓣膜以实现良好密封，同时瓣膜更可预测地安置在瓣环中。
图39是一种类型的线材框架面板的图示，其示出了在水平压缩和侧向压缩之间平衡的线材框架构型。
图40是一种类型的线材框架面板的图示，其示出了相比侧向压缩更倾向于水平压缩的线材框架构型。
图41是经由股静脉经皮递送的假体三尖瓣的图示。
图42是一种类型的线材框架面板的图示，其示出了相比侧向压缩更倾向于水平压缩的线材框架构型。
图43是一种类型的线材框架面板的图示，其示出了在水平压缩和侧向压缩之间平衡的线材框架构型。
图44是束紧并安置在三尖瓣瓣环中的瓣膜的图示。
图45是在束紧并安置在三尖瓣瓣环中之后释放的瓣膜的图示。
图46是束紧并安置在二尖瓣瓣环中的瓣膜的图示。
图47是在束紧并安置在二尖瓣瓣环中之后释放的瓣膜的图示。
图48是根据本发明的具有不透射线标记的内部回流控制部件的侧透视图的图示，该内部回流控制部件作为可正交递送的经导管心脏瓣膜的一部分，该心脏瓣膜具有安装在瓣环外部支撑框架内的可塌缩流动控制部件，该可塌缩(内部)流动控制部件具有其上安装有2-4个柔性小叶的小叶框架，小叶框架可沿着z轴从圆柱形构型折叠成扁平圆柱体构型并且可沿着竖直轴线(y轴)压缩成缩短构型，并且瓣膜具有超弹性线材环远端接片和超弹性线材环近端接片。
图49是根据本发明的具有带有不透射线标记的内部回流控制部件的实施方案的侧透视分解图的图示，三个小叶尖或袋安装在可折叠且可压缩的内部线材框架内，内部安装在外部线材框架内，该外部线材框架具有周向附接在外部线材框架的顶部边缘处的套环部件，双接片部件和网状部件。
图50是根据本发明的具有带有不透射线标记的内部回流控制部件的实施方案的侧透视分解图的图示，三个小叶尖或袋安装在可折叠且可压缩的内部线材框架内，内部安装在外部线材框架内，该外部线材框架具有周向附接在外部线材框架的顶部边缘处的套环部件，一对集成的独立接片部件和网状部件。
图51是根据本发明的沿着z轴(当从较宽侧观察时从前到后)处于折叠构型的可正交递送的经导管心脏瓣膜的侧透视图的图示。
图52是根据本发明的处于竖直压缩构型的可正交递送的经导管心脏瓣膜的侧透视图的图示。
图53是根据本发明的部分地装载到递送导管中的可正交递送的经导管心脏瓣膜的侧透视图的图示。
具体实施方式
本发明涉及束紧设备，该束紧设备用于从远端到近端减小瓣膜的尺寸，以便于将大的正交瓣膜部署到自体瓣环中，然后释放束紧构型并允许瓣膜一旦定位在瓣环内就扩张，以实现用于双接片经导管心脏瓣膜置换的可靠密封，该双接片经导管心脏瓣膜置换是低轮廓、正交递送的可植入假体心脏瓣膜，该假体心脏瓣膜具有环形或瓣环支撑框架，内部2面板或3面板套筒，延伸到右心室流出道中的细长瓣环下方远端锚固接片，优选地在前小叶和后小叶之间延伸到近端瓣环下方空间中的细长瓣环下方近端锚固接片。
在一些实施方式中，本文描述的实施方案涉及具有集成束紧设备的侧面递送的经导管假体心脏瓣膜，该侧面递送的经导管假体心脏瓣膜包括：(a)自扩张瓣环支撑框架，所述瓣环支撑框架具有中心通道和外周壁，该外周壁以扩张构型包围中心竖直轴线，心房密封套环围绕外周壁的顶部边缘的至少一部分设置，所述瓣环支撑框架具有远侧和近侧；(b)集成束紧设备，其包括附接到瓣环支撑框架的细长系绳或条带，该系绳或条带由可操纵导管的控制柄部致动以束紧或减小瓣环支撑框架的近侧的径向尺寸；(c)流动控制部件，其被安装在瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过瓣膜的流入端并且阻止血液沿与第一方向相反的第二方向流动通过瓣膜的流出端；(d)瓣环下方远端锚固接片或张力臂，其附接到周壁的远端部分，并且远离周壁延伸10mm-40mm；(e)瓣环下方近端锚固接片或张力臂，其附接到周壁的近端部分，并且远离周壁延伸5mm-20mm；其中瓣膜可被压缩至压缩构型以便使用递送导管引入身体内以在身体内的期望位置处进行植入，所述压缩构型以与中心竖直轴线成45度-135度之间的交角沿着水平轴线取向，并且可扩张至具有与中心竖直轴线成45度-135度之间的交角的水平轴线的扩张构型；其中瓣膜的压缩构型的水平轴线基本上平行于递送导管的纵向圆柱轴线；其中瓣膜具有约5mm-60mm的高度和约25mm-80mm的直径。
本文描述的假体心脏瓣膜中的任一者可包括具有两(2)根或更多根系绳的集成束紧设备。
本文描述的假体心脏瓣膜中的任一者可包括其中集成束紧设备包括单拉系绳机构、双系绳牵拉系统、多系绳扭转机构或带束紧机构。
本文描述的假体心脏瓣膜中的任一者可包括其中系绳为编织聚乙烯、经处理的心包组织、ePTFE或镍钛诺(Nitinol)。
本文描述的假体心脏瓣膜中的任一者可包括其中系绳或条带具有齿状物部分并且释放元件具有接合齿状物的可释放棘爪元件。
本文描述的假体心脏瓣膜中的任一者可包括其中第一系绳或条带附接到周壁的中隔侧的顶部部分，并且第二系绳或条带附接到周壁的中隔侧的底部部分。
本文描述的假体心脏瓣膜中的任一者可包括其中系绳或条带可释放地附接到瓣环下方近端锚固接片，并且近端锚固接片被配置成从抵靠周壁的折叠起来的位置移动到远离周壁折叠的扩张位置，其中近端锚固接片具有接片锚固元件，并且系绳或条带具有接片释放元件，该接片释放元件与接片锚固元件协作以将近端锚固接片从折叠起来的位置移动到扩张位置。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环支撑框架覆盖有生物相容性材料。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环支撑框架包括多个可压缩线材单元，该可压缩线材单元具有基本上正交于中心竖直轴线的取向和单元几何形状，以在瓣环支撑框架被配置成处于竖直压缩构型、卷起压缩构型或折叠压缩构型时使线材单元应变最小化。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环支撑框架具有下部主体部分和上部套环部分，其中处于扩张构型的下部主体部分形成选自漏斗、圆柱体、平锥体或圆形双曲面的形状。
本文描述的假体心脏瓣膜中的任一者可包括其中所述瓣环支撑框架包括编织线材或激光切割线材框架，并且所述瓣环支撑框架覆盖有生物相容性材料。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环支撑框架具有直径R为40mm-80mm、直径r为20mm-60mm并且高度为5mm-60mm的平锥体形状的侧面轮廓。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环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，其选自以下情形：内表面覆盖有心包组织，外表面覆盖有织造合成聚酯材料，以及内表面覆盖有心包组织并且外表面覆盖有织造合成聚酯材料。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环支撑框架具有顶径R1为40mm-80mm、底径R2为50mm-70mm、内径r为20mm-60mm并且高度为5mm-60mm的沙漏形状的侧面轮廓。
本文描述的假体心脏瓣膜中的任一者可包括其中处于扩张构型的瓣膜具有基本上平行于第一方向的中心竖直轴线。
本文描述的假体心脏瓣膜中的任一者可包括其中流动控制部件具有20mm-40mm的内径，并且心包材料的多个小叶在流入端处连接以形成圆形圆柱体并且在流出端处具有平坦的可闭合孔。
本文描述的假体心脏瓣膜中的任一者可包括其中流动控制部件用集成到流动控制部件中或安装到流动控制部件上的一个或多个纵向支撑件支撑，该一个或多个纵向支撑件选自刚性或半刚性柱、刚性或半刚性肋、刚性或半刚性板条、刚性或半刚性面板，以及它们的组合。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环下方远端锚固接片包括线材环、线材框架、激光切割框架、集成框架区段、或支架，并且远端锚固接片远离瓣环支撑框架的远侧延伸约20mm-40mm。
本文描述的假体心脏瓣膜中的任一者可包括其中近端锚固接片包括线材环、线材框架、激光切割框架、集成框架区段、或支架，并且近端锚固接片远离瓣环支撑框架的近侧延伸约10mm-20mm。
本文描述的假体心脏瓣膜中的任一者可包括附接到该瓣环支撑框架的远端上边缘的上部远端锚固接片，该上部远端锚固接片包括线材环、线材框架、激光切割框架、集成框架区段、或支架，并且远离瓣环支撑框架延伸约10mm-20mm。
本文描述的假体心脏瓣膜中的任一者可包括其中至少一个组织锚固件连接到瓣环支撑框架以用于接合自体组织。
本文描述的假体心脏瓣膜中的任一者可包括其中外周壁包括作为第一平坦面板的前壁部分和作为第二平坦面板的后壁部分，并且其中近端折叠区域和远端折叠区域各自包括缝合接缝、织物面板、刚性铰链或没有任何线材单元的柔性织物跨距。
本文描述的假体心脏瓣膜中的任一者可包括其中瓣环支撑框架包括可压缩线材单元，该可压缩线材单元选自由以下项组成的组：编织线材单元，激光切割线材单元，光刻产生的线材单元，3D打印线材单元，由波浪形、之字形或螺旋形的间断连接的单股线材形成的线材单元，以及它们的组合。
本文描述的假体心脏瓣膜中的任一者可包括其中本发明提供了用于制造正交递送的经导管假体心脏瓣膜框架的方法，该方法包括：使用增材或减材金属或金属合金制造来生产自扩张瓣环支撑框架，所述瓣环支撑框架具有中心通道以及以扩张构型包围中心竖直轴线的外周壁，心房密封套环围绕外周壁的顶部边缘的至少一部分设置，所述瓣环支撑框架具有远侧和近侧，集成束紧设备，流动控制部件，该流动控制部件安装在瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过瓣膜的流入端并且阻止血液沿与第一方向相反的第二方向流动通过瓣膜的流出端，附接到瓣环支撑框架的集成瓣环下方锚固件系统，该锚固件系统包括在远端处附接到刚性环的细长系绳或条带，以及可滑动地附接到细长系绳或条带的可滑动锁定元件，安装在瓣环支撑框架的远侧上的远端锚固接片，安装在瓣环支撑框架的近侧上的近端锚固接片，其中瓣膜可压缩至压缩构型以便使用递送导管引入身体内以在身体内的期望位置处进行植入，所述压缩构型以与中心竖直轴线成45度-135度之间的交角沿着水平轴线取向，并且可扩张至具有与中心竖直轴线成45度-135度之间的交角的水平轴线的扩张构型，其中瓣膜的压缩构型的水平轴线基本上平行于递送导管的纵向圆柱轴线，其中瓣膜具有约5mm-60mm的高度和约25mm-80mm的直径，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(粉末熔融)，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。
本文描述的假体心脏瓣膜中的任一者可包括以下另外的步骤：(ii)将流动控制部件安装在瓣膜框架内，所述流动控制部件被配置成允许血液沿着中心竖直轴线流动通过流动控制部件的流入端并且阻止血液流动通过瓣膜的流出端，(iii)用心包材料或类似的生物相容性材料覆盖瓣膜框架的外表面。
用于压缩可植入假体心脏瓣膜以从递送导管纵向正交释放瓣膜的方法中的任一者可包括以下步骤：将可植入假体心脏瓣膜压扁、卷起或折叠成压缩构型，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，其中可植入假体心脏瓣膜包括瓣环支撑框架，该瓣环支撑框架具有流动控制部件，该流动控制部件安装在瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过瓣膜的流入端并且阻止血液沿与第一方向相反的第二方向流动通过瓣膜的流出端，附接到瓣环支撑框架的集成束紧系统，安装在瓣环支撑框架的远侧上的远端锚固接片，安装在瓣环支撑框架的近侧上的近端锚固接片，其中瓣膜具有约5mm-60mm的高度和约25mm-80mm的直径。
在另一个优选的实施方案中，其中使用选自由以下项组成的组的步骤将可植入假体心脏瓣膜卷起或折叠成压缩构型：从瓣环支撑框架的一侧单侧地卷成压缩构型，从瓣环支撑框架的两个相对侧双侧地卷成压缩构型；将瓣环支撑框架压扁成基本上平行于长轴的两个平行面板，然后将扁平瓣环支撑框架卷成压缩构型；以及沿着竖直轴线压扁瓣环支撑框架，以从顶部到底部减小瓣膜的竖直尺寸。
在另一个优选的实施方案中，用于将可植入假体心脏瓣膜正交递送到身体内的期望位置的方法，该方法可包括以下步骤：将递送导管推进到身体内的期望位置，以及通过从递送导管释放可扩张的假体心脏瓣膜来将该瓣膜递送到身体内的期望位置，其中瓣膜包括自扩张瓣环支撑框架，所述瓣环支撑框架具有中心通道以及以扩张构型包围中心竖直轴线的外周壁，心房密封套环围绕外周壁的顶部边缘的至少一部分设置，所述瓣环支撑框架具有远侧和近侧，集成束紧设备；流动控制部件，该流动控制部件安装在瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过瓣膜的流入端并且阻止血液沿与第一方向相反的第二方向流动通过瓣膜的流出端，安装在瓣环支撑框架的远侧上的远端锚固接片，以及安装在瓣环支撑框架的近侧上的近端锚固接片，其中所述瓣膜可束紧成具有从扩张构型减小5％-30％的椭圆形周长的束紧构型，或者具有其中顶部边缘的长轴在直径上减小5％-30％的束紧构型，其中瓣膜可压缩至高度为5mm-10mm并且宽度为5mm-10mm的压缩构型以便使用递送导管引入身体内以在身体内的期望位置处进行植入，所述压缩构型具有以与第一方向成45度-135度之间的交角取向的长轴，并且可扩张至具有以与第一方向成45度-135度之间的交角取向的长轴的扩张构型，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，其中瓣膜具有约5mm-60mm的高度和约25mm-80mm的直径。
参考在附图中示出并在以下说明中详细描述的非限制性实施方案，对本文中的实施方案及其各种特征和有利细节进行更全面的解释。省略了对公知的部件和处理技术的描述，以免不必要地模糊本文的实施方案。本文使用的实施例仅仅是为了便于理解可以实践本文的实施方案的方式，并且进一步使得本领域技术人员能够实践本文的实施方案。因此，实例不应被解释为限制本文的实施方案的范围。
相反，提供这些实施方案是为了使本公开全面和完整，并且将向本领域技术人员充分传达本发明的范围。相似的数字通篇是指相似的元件。如本文所用，术语“和/或”包括相关所列项目中的一者或多者的任何和所有组合。
本文使用的术语仅用于描述特定实施方案的目的，并不旨在限制本发明的全部范围。如本文所用，单数形式“一”，“一个”和“该”也旨在包括复数形式，除非上下文另外明确指出。还应当理解，当在本说明书中使用时，术语“包括”和/或“包含”指定所述特征、整体、步骤、操作、元件和/或部件的存在，但不排除一个或多个其他特征、整体、步骤、操作、元件、部件和/或其组的存在或添加。
除非另有定义，否则本文所用的所有技术和科学术语具有与本领域普通技术人员通常理解相同的含义。本公开中的任何内容都不应被解释为承认本公开中描述的实施方案无权借助现有发明而先于这种公开。如本文件中所用，术语“包含”是指“包括但不限于”。
在不脱离其精神和范围的情况下，可以进行许多修改和变化，如对于本领域技术人员来说显而易见的。除了本文列举的那些方法和设备之外，本公开范围内的功能等同的方法和设备对于本领域技术人员来说根据前面的描述将是显而易见的。此类修改和变化旨在落入所附权利要求书的范围内。本公开仅由所附权利要求书的条款以及此类权利要求有权获得的等同物的全部范围来限制。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，这些方法、试剂、化合物、组合物或生物系统当然可以变化。还应当理解，本文中使用的术语仅仅是为了描述特定的实施方案，而不是旨在进行限制。
关于本文中的基本上任何复数和/或单数术语的使用，本领域技术人员可以根据上下文和/或应用将复数转化成单数并且/或者将单数转化成复数。为了清楚起见，可能在本文中明确地阐述了各种单数/复数排列。
本领域技术人员将理解，一般而言，本文中，尤其是在所附权利要求书(例如，所附权利要求的正文)中使用的术语通常被认为是“开放的”术语(例如，术语“包括”应被解释为“包括但不限于”，术语“具有”应被解释为“至少具有”，术语“包含”应被解释为“包含但不限于”等)。本领域的技术人员将进一步理解，无论在说明书、权利要求书还是附图中，呈现两个或更多个替代项的几乎任何反意连接词和/或短语都应该被理解为考虑了包括其中一项、任一项，或两项的可能性。例如，短语“A或B”将被理解为包括“A”或“B”或“A和B”的可能性。
另外，在以马库什群组(Markush group)描述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也由此以马库什群组的任何独立成员或成员的子组来描述。
如本领域技术人员将理解的，出于任何和所有目的，诸如就提供书面描述而言，本文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。任何列出的范围可以容易地被认为是充分地描述相同的范围并且使得相同的范围能够被分解为至少相等的子部分。如本领域技术人员将理解的，范围包括每个单独的成员。
定义
集成束紧设备
在本文的说明书和权利要求书中，术语“集成束紧设备”、“束紧”用于描述细长系绳，该系绳以这样的方式附接到瓣膜的框架上，即，拉动系绳将折叠/收紧/弯曲瓣环支撑框架的周壁，从而减小整个瓣膜的周长，使得更容易将瓣膜部署到自体瓣环中。系绳(在外部)附接到或(在内部)延伸穿过假体瓣膜的主体/周壁和/或套环部分。在优选的实施方案中，束紧设备可具有不透射线的标记或不透射线的材料或结构，使得递送系统导管可通过患者的身体被引导到安装或将要安装瓣膜的部位。在一个优选的实施方案中，正交瓣膜的递送是(纵向递送，高度压缩和宽度压缩)通过股静脉到下腔静脉(IVC)到心脏的右心房，用于锚固假体三尖瓣心脏瓣膜置换物，随后IVC递送锚固系统以安装瓣环下方锚固件。
侧面递送的、侧面递送或正交
在本文的说明书和权利要求书中，术语“侧面递送的”、“侧面递送”或“正交”用于描述与传统的经导管心脏瓣膜相比，本发明的瓣膜以大致90度角压缩和递送。传统的瓣膜具有与递送导管的纵向轴线平行的中心圆柱体轴线，并且以类似于将闭合的伞状物推出套筒的方式从递送导管的端部部署。本发明的瓣膜以侧向方式压缩和递送。传统的瓣膜只能扩张到与递送导管的内径将允许的一样大。增加传统瓣膜的扩张直径的努力遇到了试图将太多的材料和结构压缩到太小的空间中的问题。在数学上，术语正交是指两个线或平面之间90度的交角。如本文所用，术语“基本上正交”是指75度至105度范围内的交角。交角或正交角是指(i)递送导管的纵向圆柱轴线与本发明的压缩瓣膜的长轴线之间的关系，其中长轴垂直于传统瓣膜的中心圆柱体轴线，以及(ii)本发明的压缩或扩张的瓣膜的长轴与由流动通过假体瓣膜的血液所限定的轴线之间的关系，其中血液是流动的，例如从身体或心脏腔室的一部分流动到身体或心脏腔室的另一下游部分，诸如，通过自体瓣环从心房流动到心室。
经导管
在本文的说明书和权利要求书中，术语“经导管”用于定义进入、控制和递送被部署到心脏腔室中的导管内腔内的医疗装置或器械的过程，以及已经由这样的过程递送或控制的项目。已知经导管通路包括经股动脉和股静脉、经肱动脉和肱静脉、经颈动脉和颈静脉、经肋间(肋骨)空间、以及经剑突下方。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。
在本发明的优选的实施方案中，经导管途径包括(i)经股静脉通过下腔静脉推进到心脏的三尖瓣或肺动脉，(ii)经颈静脉通过上腔静脉推进到心脏的三尖瓣或肺动脉，(iii)经IVC股静脉或SVC颈静脉途径通过经心房途径(例如，卵圆窝更低处)推进到心脏的二尖瓣。
瓣环支撑框架
在本文的说明书和权利要求书中，术语“瓣环支撑框架”以及“线材框架”或“凸缘”或“套环”是指三维结构部件，该三维结构部件安置在自体瓣膜瓣环内并用作小叶结构、流动控制部件或柔性往复套筒或套筒瓣膜的安装元件。
在优选的实施方案中，瓣环支撑框架是自扩张瓣环支撑框架，其具有中心通道以及以扩张构型包围中心竖直轴线的外周壁。周壁涵盖套环和下部主体部分两者。
周壁可进一步限定为具有前壁部分和后壁部分，它们沿着(IVC的)近侧或近侧连接到近端折叠区域，并且沿着远侧或远侧连接到远端折叠区域。
该前壁部分可进一步限定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。
瓣环支撑框架具有流动控制部件，该流动控制部件被安装在瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过瓣膜的流入端并且阻止血液沿与第一方向相反的第二方向流动通过瓣膜的流出端。
由于框架优选地由超弹性金属或合金如镍钛诺制成，因此框架是可压缩的。优选地，框架由多个可压缩线材单元构成，该可压缩线材单元具有基本上正交于中心竖直轴线的取向和单元几何形状，以在瓣环支撑框架被配置成处于竖直压缩构型、卷起压缩构型或折叠压缩构型时使线材单元应变最小化。
瓣环支撑框架结构
瓣环支撑框架可以是由耐久的、生物相容的结构材料诸如镍钛诺或类似合金制成的环、或者圆柱形或圆锥形管，其中瓣环支撑框架通过将结构材料制造成编织线材框架、激光切割线材框架或线材环来形成。考虑到线材材料本身的厚度，瓣环支撑框架的高度为约5mm-60mm、外径尺寸R为30mm-80mm、内径尺寸为31mm-79mm。如上所述，瓣环支撑框架可具有环形状、圆柱体形状、圆锥形管形状的侧面轮廓，但也可具有以下的侧面轮廓：平锥体形状，倒平锥体形状(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)，角形沙漏，弯曲的有刻度的沙漏，具有向外展开的顶部、向外展开的底部或者两者的环或圆柱体。在一个优选的实施方案中，部署在三尖瓣瓣环中的假体心脏瓣膜中使用的瓣环支撑框架可具有由瓣膜安装在其中的解剖结构确定的复杂形状。例如，在三尖瓣瓣环中，三尖瓣的周长可以是圆形椭圆，已知中隔壁基本上是竖直的，并且已知三尖瓣在疾病状态下沿着前后线扩大。因此，假体心脏瓣膜可以以大致管状构型开始，并且被热成形以提供用于心房密封的上心房套囊或凸缘以及具有沙漏截面的下经瓣环管状或圆柱形区段，该沙漏截面占周长的约60％-80％以沿着后瓣环区段和前瓣环区段适形于自体瓣环，同时沿着瓣环周长的20％-40％保持基本上竖直平坦以适形于中隔瓣环区段。
瓣环支撑框架覆盖物
瓣环支撑框架任选地在内部或外部部分地或完全地覆盖有生物相容性材料，诸如心包。瓣环支撑框架还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)。
瓣环支撑框架用途
瓣环支撑框架具有中心轴向内腔，其中假体心脏瓣膜或流动控制结构(诸如往复可压缩套筒)跨过内腔的直径安装。瓣环支撑框架也抵靠自体瓣环的内面张紧，并且为弱化的瓣环环提供结构通畅性。
瓣环支撑框架任选套环
瓣环支撑框架可任选地具有附接到框架的上(心房)边缘的单独心房套环，用于部署在心房底上，该心房套环用于将血液从心房引导到套筒中并且用于对瓣环支撑框架周围的血液渗漏进行密封。瓣环支撑框架还可任选地具有附接到框架的下(心室)边缘的单独心室套环，用于在心室中部署在自体瓣环正下方，该心室套环用于防止心脏收缩期间的回流渗漏，防止心脏收缩期间的装置移位，将自体瓣环或相邻组织夹在或压缩在心房套环上，并且任选地附接到套筒/导管并支撑该套筒/导管。
瓣环支撑框架递送
瓣环支撑框架可被压缩用于经导管递送，并且可以作为可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、或者不具有附加套环结构的假体心脏瓣膜。
框架材料
优选地，框架由超弹性金属部件制成，诸如激光切割镍钛诺管、或者平板或其他类似功能的材料，例如编织线材。该材料可用于框架/支架，用于套环和/或用于锚固件。可以设想到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。可以设想到，框架可被构造为编织物、线材或激光切割框架。激光切割框架优选地由镍钛诺制成，但也非限制性地由不锈钢、钴铬、钛和其他功能等同的金属和合金制成。
框架设计的一个关键方面在于它是可压缩的，并且当释放时具有所述的特性，即它返回到其原始(未压缩)形状。该要求将潜在的材料选择限于具有形状记忆特性的金属和塑料。关于金属，已经发现镍钛诺是特别有用的，因为它可被加工成奥氏体的、马氏体的或超弹性的。马氏体和超弹性合金可被加工以显示所需的机械行为。
瓣环框架锚固件元件
束紧系绳可释放地附接到瓣膜，并且包括用于如何致动系绳的各种机构。在一个实施方案中，系绳的端部具有释放装置，并且系绳的其余部分穿过安装在框架上的引导孔或管。在另一个实施方案中，系绳附接到多个位置，以便以一个大的弯曲或以多个较小的弯曲折叠瓣膜的一侧或两侧(周壁)。在另一个实施方案中，可存在不止一根系绳。例如，在一个实施方案中，在瓣膜的一侧上可存在两根系绳，从而仅减小一侧。在另一个实施方案中，在瓣膜的相对侧(例如，中隔侧和前侧)上可存在系绳，以使瓣膜的周长收缩或塌缩。
激光切割
线材框架的一种可能的构造设想到激光切割薄的等直径镍钛诺管。激光切割在薄的镍钛诺管中形成规则切口。在一个优选的实施方案中，镍钛诺管扩张以形成由菱形单元形成的三维结构。该结构还可以具有附加功能元件，例如环、锚固件等，用于附接诸如生物相容性覆盖物、组织锚固件、可释放的部署和收回控制引导件、旋钮、附接件、索具等的附件部件。
其次，使用工业标准镍钛诺成形方法对管进行热机械加工。以这种方式处理线材框架将形成具有形状记忆特性的装置，并且一旦部署将容易恢复到记忆形状。
编织线材
线材框架的另一种可能的构造设想到利用使用镍钛诺线材和简单编织固定装置的简单编织技术。线材以一定图案缠绕在编织固定装置上，直到形成等直径管。其次，将编织线材框架放置在成形固定装置上并使用工业标准镍钛诺成形方法进行加工。
流动控制部件
在本文的说明书和权利要求书中，术语“流动控制部件”在非限制性意义上是指起到假体心脏瓣膜的作用的具有2小叶、3小叶、4小叶的柔性生物相容性材料(诸如缝合或连接到环形支撑框架的经处理或未经处理的心包)的小叶结构。这样的瓣膜可以是心脏瓣膜，诸如三尖瓣、二尖瓣、主动脉瓣膜或肺动脉瓣膜，其在心脏舒张期间对从心房到心室的血流开放，并且从向外表面施加心室收缩压开始关闭。按顺序重复的打开和关闭可被描述为“往复”。在瓣膜中瓣膜实施方案中，流动控制部件被设想为还包括多种(生物)假体人工心脏瓣膜，包括球瓣膜(例如，Starr-Edwards)、双叶瓣膜(St.Jude)、侧倾碟瓣膜(例如，Bjork-Shiley)、带支架心包心脏瓣膜假体(牛、猪、羊)(Edwards生物假体系列，St.Jude假体瓣膜)，以及同种移植瓣膜和自体移植瓣膜。生物假体心包瓣膜可包括生物假体主动脉瓣膜、生物假体二尖瓣、生物假体三尖瓣和生物假体肺动脉瓣膜。
经导管
术语“经导管”用于定义进入、控制和/或递送被部署到心脏腔室(或身体内的其他期望位置)中的导管内腔内的医疗装置或器械的过程，以及已经由这样的过程递送或控制的项目。已知经导管通路包括经股动脉和/或股静脉的内腔、经肱动脉和/或肱静脉的内腔、经颈动脉的内腔、经颈静脉的内腔、经肋间(肋骨)间隙和/或剑突下方空间等的心脏通路。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。如本文所用，术语“内腔”可以指圆柱体或管的内部。术语“口径(bore)”可以指内腔的内径。
组织锚固件
在本文的说明书和权利要求书中，术语“组织锚固件”或“褶皱组织锚固件”或“次级组织锚固件”或“镖”或“销”是指通常在套环的周边处或附近将上心房框架连接到自体瓣环组织的紧固装置。锚固件可以被定位成避免刺穿组织，并且仅依赖于两个板状套环对所捕获的组织的压缩力，或者锚固件本身或与集成固定线材一起可以刺穿自体组织以提供锚固，或者两者的组合。锚固件可具有专用的固定机构，诸如具有凹槽和带凸缘的肩部的尖头尖端，该尖头尖端插入或弹入配合孔或配合孔阵列中，该配合孔允许锚固件附连，但当孔周边锁定到带凸缘的肩部附近的凹槽中时防止脱离。固定线材可通过任何附接或锚固机构附接或锚固到与销相对的套环，该附接或锚固机构包括结、缝线、线材卷曲件、具有凸轮机构的线材锁或其组合。
支撑柱
术语“支撑柱”是指一段刚性或半刚性材料，诸如镍钛诺或PEEK，其可安装在辐条式框架上，并且轴向延伸，或者沿柔性套筒的中心向下延伸，或者在柔性套筒的缝合接缝内延伸。套筒可以不附接到支撑柱，或者套筒可以直接或间接地附接到支撑柱。
在下面的描述中，术语“身体通道”用于限定身体内的血液管道或血管。当然，假体心脏瓣膜的特定应用决定了所讨论的身体通道。例如，主动脉瓣膜置换物将被植入主动脉瓣环中或邻近主动脉瓣环植入。同样，将在三尖瓣瓣环或二尖瓣瓣环处植入三尖瓣或二尖瓣置换物。本发明的某些特征对于一个植入部位或另一个植入部位是特别有利的。然而，除非该组合在结构上是不可能的，或者被权利要求语言排除，否则本文描述的任何心脏瓣膜实施方案都可被植入任何身体通道中。
术语“内腔”是指圆柱体管的内部。术语“口径”是指内径。
排量-由一个完整冲程或旋转排出的流体体积。
射血分数是每次收缩时离开心脏的血液百分比的测量结果。在每个心跳泵送循环期间，心脏收缩和舒张。当心脏收缩时，它从两个泵室(心室)射出血液。
作为进一步定义的要点，术语“可扩张的”在本文中用于指心脏瓣膜的能够从第一递送直径扩张到第二植入直径的部件。因此，可扩张的结构并不意指可能因温度升高或其他这样的偶然原因而发生轻微扩张的结构。相反，“不可扩张的”不应被解释为意指完全刚性或尺寸稳定的，因为例如可以观察到常规“不可扩张的”心脏瓣膜的一定程度的轻微扩张。
假体心脏瓣膜
术语“假体”或“假体的”涵盖解剖部分的完全置换物(例如，新的机械瓣膜置换自体瓣膜)，以及代替并且/或者辅助、修复或改善现有解剖部分(例如，自体瓣膜留在原位)的医疗装置。为了安装在被动式辅助笼内，本发明设想了多种(生物)假体人工心脏瓣膜。设想为在本发明范围内的是球瓣膜(例如，Starr-Edwards)、双叶瓣膜(St.Jude)、侧倾碟瓣膜(例如，Bjork-Shiley)、带支架心包心脏瓣膜假体(牛、猪、羊)(Edwards生物假体系列，St.Jude假体心脏瓣膜)，以及同种移植瓣膜和自体移植瓣膜。对于生物假体心包瓣膜，可以设想到使用生物假体主动脉瓣膜、生物假体二尖瓣、生物假体三尖瓣和生物假体肺动脉瓣膜。
系绳-
系绳由手术级材料制成，例如生物相容性聚合物缝线材料。这样的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，系绳是无弹性的。还可以设想到，系绳中的一根或多根系绳可任选地为弹性的，以在心动周期期间提供瓣膜的更大程度的顺应性。
尖齿-锚固件-尖齿/倒钩
可以通过使用尖齿或倒钩将装置安置在瓣膜瓣环内。这些可与一根或多根系绳结合使用或代替一根或多根系绳。尖齿或倒钩被定位成提供与相邻组织的附接。通过机械装置诸如使用球囊导管迫使尖齿进入瓣环组织。在一个非限制性实施方案中，尖齿可以任选地是半圆形钩，其在线材框架主体扩张时刺穿，旋转进入并牢固地保持瓣环组织。通过递送导管经线材递送一个或多个锚固件来部署锚固件。导管可具有多个轴向内腔，用于递送各种锚固工具，包括锚固件设定工具、施力工具、钩、圈套工具、切割工具、射频和放射可视化工具和标记、以及缝线/线操纵工具。一旦锚固件附接到节制带，便可使用张紧工具来调节连接到植入瓣膜的系绳的长度，以根据需要调节和固定植入物，以便正常起作用。还可以设想到，锚固件可以是弹簧加载的，并且可具有构建到锚固件的拴系面中的系绳附接件或系绳捕获机构。锚固件还可具有向内生长材料，诸如聚酯纤维，以促进锚固件向内生长到心肌中。
在一个实施方案中，在假体心脏瓣膜可以包括或可以不包括心室套环的情况下，锚固件或镖不附接到下心室套环，而是直接附接到瓣环组织或用于锚固的其他组织中。
聚合物
在一些实施方案中，部件可由诸如聚氨酯或聚四氟乙烯(PTFE)之类的合成材料制成。在设想到薄的耐久合成材料(例如，用于覆盖物)的情况下，可以任选地使用合成聚合物材料，诸如膨胀PTFE或聚酯。其他合适的材料可任选地包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、多嵌段聚醚聚氨酯、有机硅聚醚聚氨酯、聚醚醚酮(PEEK)、有机硅聚碳酸酯聚氨酯、聚丙烯、聚乙烯、低密度聚乙烯、高密度聚乙烯和超高分子量聚乙烯。附加生物相容性聚合物可任选地包括弹性体、聚烯烃、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、聚酯、聚对苯二甲酸乙二醇酯(PET)(例如，Dacron)、聚-L-乳酸(PLLA)、聚乙醇酸(PGA)、聚(D,L-丙交酯/乙交酯)共聚物(PDLA)、有机硅聚酯、聚酰胺(尼龙)、PTFE、细长PTFE、膨胀PTFE、聚氨酯、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。
部件
在一些实施方案中，瓣膜框架和/或其部件可由生物相容性金属、金属合金、聚合物涂覆的金属等制成。合适的生物相容性金属和/或金属合金可包括不锈钢(例如，316L不锈钢)、钴铬(Co-Cr)合金、镍钛合金(例如，
Figure BDA0003358389900000261
)等。合适的聚合物涂层可包括聚乙烯乙酸乙烯酯(PEVA)、聚甲基丙烯酸丁酯(PBMA)、translute苯乙烯-异戊二烯-丁二烯(SIBS)共聚物、聚乳酸、聚酯、聚交酯、D-乳酸聚乳酸(DLPLA)等。
覆盖物
任何瓣膜框架和/或其部分或部件可在内部或外部部分或完全地覆盖有生物相容性材料(诸如心包)。瓣膜框架还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
Figure BDA0003358389900000262
所公开的实施方案可使用组织，诸如作为动物诸如牛(牛心包)、绵羊(羊心包)、猪(猪心包)或马(马心包)的化学稳定的心包组织的生物组织。优选地，组织是牛心包组织。合适的组织的实例包括在产品
Figure BDA0003358389900000263
Figure BDA0003358389900000264
和
Figure BDA0003358389900000265
以及目前用于外科手术并被营销为一般从小于30个月的牛中获取的所有产品中使用的组织。
覆盖线材框架材料
药物洗脱线材框架被设想为在本文中使用。DES基本上由三个部分组成：线材框架平台、涂层和药物。无聚合物DES的一些实例是使用Amazonia CroCo(L605)钴铬(Co-Cr)线材框架的Amazon Pax(MINVASYS)，其中紫杉醇作为抗增殖剂，并且来自内腔的涂层已经用作药物的载体。BioFreedom(Biosensors Inc.)使用不锈钢作为基底，其中改良的来自内腔的涂层作为抗增殖药物优美莫司(Biolimus)A9的载体表面。Optima(CID S.r.l.)使用316L不锈钢线材框架作为药物他克莫司(Tacrolimus)的基底，并且使用集成混层碳膜作为药物载体。VESTA sync(MIV Therapeutics)使用GenX不锈钢(316L)作为基底，使用微孔羟基磷灰石涂层作为药物西罗莫司(Sirolimus)的载体。YUKON choice(Translumina)使用316L不锈钢作为药物西罗莫司与普罗布考(Probucol)组合的基底。
可生物吸收的聚合物在本文中也可用作药物的载体基质。Cypher、Taxus和Endeavour是三种基本类型的可生物吸收的DES。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不锈钢来携带药物西罗莫司。Taxus(Boston Scientific)使用涂覆有translute苯乙烯-异戊二烯-丁二烯(SIBS)共聚物的316L不锈钢线材框架来携带紫杉醇，紫杉醇在约90天的周期内洗脱。Endeavour(Medtronic)使用钴铬驱动线材框架来携带唑他莫司(zotarolimus)与磷酰胆碱作为药物载体。BioMatrix采用S-线材框架(316L)不锈钢作为基底，其中聚乳酸表面用于携带抗增殖药物优美莫司。ELIXIR-DES程序(Elixir Medical Corp)包括聚酯和聚交酯涂覆的线材框架来携带药物诺维莫司(novolimus)与钴-铬(Co-Cr)作为基底。JACTAX(BostonScientific Corp.)利用D-乳酸聚乳酸(DLPLA)涂覆的(316L)不锈钢线材框架来携带紫杉醇。NEVO(Cordis Corporation,Johnson&Johnson)使用涂覆有聚乳酸-羟基乙酸共聚物(PLGA)的钴铬(Co-Cr)线材框架来携带药物西罗莫司。
实施例
经导管假体心脏瓣膜可以使用经导管过程经股骨，通过IVC、颈动脉、剑突下方、肋间通路，跨过胸壁，以及经中隔通过卵圆窝递送到二尖瓣瓣环。
该装置经由导管递送到右心房或左心房，并且从与导管内腔的内径配合的压缩形状扩张。压缩瓣膜在患者体外装载到递送导管中，然后在囊状物到达心房时被推出导管。心脏治疗技师使用诸如荧光透视或超声之类的可用成像技术来使该递送可视化。
在优选的实施方案中，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，诸如
Figure BDA0003358389900000281
镍钛合金、或钴铬合金、用于生物医学植入物的合金。
在另一个实施方案中，瓣膜可由在囊状物已经从导管射出到心房中之后需要球囊扩张的材料构成。
当心房套环/框架和流动控制部件部署到自体瓣环中时，心房套环/框架和流动控制部件扩张到它们的功能直径，从而提供径向张力以固定瓣膜。一旦围绕三尖瓣瓣环部署框架，紧固件将装置固定在自体瓣环周围。可执行装置到自体结构的附加紧固，并且完成部署。使用血液动力学成像技术的另外的调节被设想为在本发明的范围内，以确保该装置是稳固的，按计划定位和取向，并且用作自体三尖瓣的替代物或接替物。
实施例-递送过程
正交递送步骤：提供可折叠的、可压缩的假体三尖瓣，将瓣膜侧向装载到递送导管中，在预先放置的引导线材上将瓣膜经由IVC或SVC推进到心脏，该预先放置的引导线材被拧到瓣环下方远端接片的引导线材环上，部分地排出瓣膜以定位远端瓣环下方接片以将瓣膜主体的通道楔靠在远端瓣环环上，其中心房套环设置在瓣环组织区域的顶表面上，并且允许瓣膜小叶开始起作用，使用束紧系统径向地减小瓣膜主体的近侧，通过安置到自体瓣环中来完成瓣膜的部署，以及延伸/展开瓣环下方近端锚固接片。
实例-制造方法
在优选的实施方案中，本发明包括用于制造正交递送的经导管假体心脏瓣膜框架的方法，该方法包括：使用增材或减材金属或金属合金制造来生产自扩张瓣环支撑框架，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(粉末熔融)，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。
在另一个优选的实施方案中，提供了一种用于制造正交递送的经导管假体心脏瓣膜框架的方法，该方法还包括以下步骤：(ii)将流动控制部件安装在瓣膜框架内，所述流动控制部件被配置成允许血液沿着中心竖直轴线流动通过流动控制部件的流入端并且阻止血液流动通过瓣膜的流出端，(iii)用心包材料或类似的生物相容性材料覆盖瓣膜框架的外表面。
实施例-压缩方法
在另一个优选的实施方案中，提供了一种压缩方法，其中使用选自由以下项组成的组的步骤将可植入假体心脏瓣膜卷起或折叠成压缩构型：从瓣环支撑框架的一侧单侧地卷成压缩构型，从瓣环支撑框架的两个相对侧双侧地卷成压缩构型；将瓣环支撑框架压扁成基本上平行于长轴的两个平行面板，然后将扁平瓣环支撑框架卷成压缩构型；以及沿着竖直轴线压扁瓣环支撑框架，以从顶部到底部减小瓣膜的竖直尺寸。
附图
现在参见附图，图1是根据实施方案的示意性剖面侧视图。图1示出了瓣膜100的下跨瓣环部分106的周边(周长)可如何向内束紧。这允许瓣膜被设计成具有过大的跨瓣环周长，例如5％-20％，通常10％-15％，以促进瓣膜在自体瓣环内的紧密配合并提供良好的密封以防止瓣周漏(PVL)。束紧过程向内拉动近侧壁并且减小跨瓣环区段106的周长。这允许过大的瓣膜在瓣膜部署期间落入自体瓣环中。然后，一旦瓣膜如所期望地安置，跨瓣环区段就被推出回到其完全或几乎完全的周长，并且由此形成假体瓣膜在自体瓣环中的紧密密封配合。
图2是根据实施方案的示意性底视图。图2示出了从下方观察的视图，并且示出了瓣膜的下跨瓣环部分的周边(周长)如何向内束紧，此处是瓣膜的跨瓣环区段的近端。这种过大的跨瓣环周长，例如5％-20％，通常10％-15％，促进瓣膜在自体瓣环内的紧密配合并提供良好的密封以防止瓣周漏(PVL)。
图3是根据近端系绳实施方案的示意性剖面侧视图。图3示出了瓣膜100的下跨瓣环部分106的周边(周长)可如何向内束紧。这允许瓣膜被设计成具有过大的跨瓣环周长，例如5％-20％，通常10％-15％，以促进瓣膜在自体瓣环内的紧密配合并提供良好的密封以防止瓣周漏(PVL)。近端束紧系绳105示出了用于执行束紧过程的非限制性机构。束紧系绳105从递送导管(未示出)行进穿过导向部件诸如孔眼111。在该实施方案中，束紧系绳105通过孔眼行进穿过套环103到达瓣膜100的下部的跨瓣环区段106的近端测114上的束紧系绳安装件。朝向操作者朝近端拉动束紧系绳向内拉动近侧壁并且减小跨瓣环区段106的周长。这允许过大的瓣膜在瓣膜部署期间落入自体瓣环中。然后，一旦瓣膜如所期望地安置，就可以推进(或者如果跨瓣环区段被弹簧偏压成折叠构型则释放)束紧系绳105，以将近侧114推出回到其完全或几乎完全的周长，并且由此形成假体瓣膜在自体瓣环中的紧密密封配合。
图4是根据远端系绳实施方案的示意性剖面侧视图。图4示出了瓣膜100的下跨瓣环部分106的周边(周长)可如何向内束紧。这允许瓣膜被设计成具有过大的跨瓣环周长，例如5％-20％，通常10％-15％，以促进瓣膜在自体瓣环内的紧密配合并提供良好的密封以防止瓣周漏(PVL)。远端束紧系绳105示出了用于执行束紧过程的非限制性机构。束紧系绳105从递送导管(未示出)行进穿过导向部件诸如孔眼111。在该实施方案中，束紧系绳105通过孔眼行进穿过套环103到达瓣膜100的下部的跨瓣环区段106的近端测114上的束紧系绳安装件。朝向操作者朝近端拉动束紧系绳向内拉动近侧壁并且减小跨瓣环区段106的周长。这允许过大的瓣膜在瓣膜部署期间落入自体瓣环中。然后，一旦瓣膜如所期望地安置，就可以推进(或者如果跨瓣环区段被弹簧偏压成折叠构型则释放)束紧系绳105，以将近侧114推出回到其完全或几乎完全的周长，并且由此形成假体瓣膜在自体瓣环中的紧密密封配合。
图5是本发明的一个实施方案的图像，其中束紧组件附接到可正交递送的瓣膜。
图5示出了具有包围圆柱形瓣膜主体的顶部边缘的瓣膜套囊/套环103的瓣膜，其中小叶258设置在安装在瓣膜主体的轴向内腔内的流动控制部件130中，并且可刺穿密封件邻近流动控制部件安装。
图5还示出了在非限制性方面中例示的束紧系统105-107-111，其中可操纵导管/控制线缆107从经导管递送导管延伸并暂时安装到套环103的远端部分中的接收器元件中。可操纵导管穿过束紧系绳105上的束紧环，并且束紧系绳穿过套环103中的孔眼111串在可操纵导管和瓣膜主体上的系绳安装件112之间，其中束紧系绳环设置在套环上方的心房侧位置处，并且束紧系绳安装件112设置在套环下方。
图5示出了通过拉动牵拉系绳105，其将在瓣膜主体上施加径向压缩或束紧力，使得当远侧保持抵靠瓣环环时，近侧可被定位并下降到瓣环环中，并且当释放时，导致瓣膜张力配合到瓣环中。
图5还示出了附接到近端接片控制导管的近端锚固接片270。近端锚固接片以折叠或收起构型开始，并且在瓣膜主体被硬塞到瓣环中之后，近端锚固接片可被展开或释放以远离瓣膜主体延伸并在近侧上提供瓣环下方锚固力(向上)。下部近端锚固件的向上力与近侧套环平衡，从而提供瓣环上方向下力。类似地，在远侧上，远端套环(向下力，心室方向)和远端锚固接片(向上力，心房方向)为瓣膜提供上部和下部夹层锚固机构。
图6是在束紧之前的瓣膜的一个实施方案的图示，其中近侧在瓣环上方(心房)位置被阻挡，并且远侧部分地安置到瓣环环上，其中远端瓣环下方(心室)接片和远端心房套囊在瓣膜周壁中形成远端凹形周向通道。
图7是在束紧期间瓣膜的一个实施方案的图示，其中近侧被束紧或暂时向内回缩以允许瓣膜的近侧向下插入瓣膜瓣环中，使得通过将近侧硬塞(或适配)到瓣环中，近侧可被释放以将其从瓣环上方位置移动到瓣环位置，并提供抵靠瓣环环的张力配合。远侧被示出为部分地安置到瓣环环上，其中远端瓣环下方(心室)接片和远端心房套囊在瓣膜周壁中形成远端凹形周向通道。
图8是示出了在3个步骤中的步骤1时处于释放位置的束紧系统的一个非限制性实施方案的图示，由此牵拉系绳和所附接的牵拉环已经勒住束紧系绳的心房部分(在瓣膜套环上方)，同时束紧系绳穿过套环中的孔眼串在下安装元件和上安装元件之间，该下安装元件在套环下方附接到周壁，该上安装元件被示出为束紧环，该束紧环紧固到锚固的可操纵导管，其中可操纵导管穿过束紧环。
图9是示出了在3个步骤中的步骤2时处于束紧位置的束紧系统的一个非限制性实施方案的图示，由此牵拉系绳和所附接的牵拉环已经勒住并牵拉束紧系绳的心房部分(在瓣膜套环上方)，其中束紧系绳的下部部分(在套环下方)向前缩短并且将瓣膜框架周壁拉动至(主体)压缩位置，其中束紧系绳穿过套环中的孔眼串在下安装元件和上安装元件之间，该下安装元件在套环下方附接到周壁，该上安装元件被示出为束紧环，该束紧环紧固到锚固的可操纵导管，其中可操纵导管穿过束紧环。
图10是示出了在3个步骤中的步骤3时回到释放位置的束紧系统的一个非限制性实施方案的图示，由此通过将束紧/压缩的近侧周壁降低到瓣环环中并释放束紧系统以使周壁抵靠自体瓣环的近侧扩张而将瓣膜安置到自体瓣环中。
图11是示出束紧系统的一个非限制性实施方案的图示，其示出了可操纵导管被致动(旋转，旋开)以从(螺纹)接收器脱离。
图12是示出束紧系统的一个非限制性实施方案的图示，并且示出了可操纵导管被拉出束紧系绳的束紧环/孔眼，其中可操纵导管被完全抽回到递送导管中并且从患者体内抽出。
图13是示出束紧系统的一个非限制性实施方案的图示，并且示出了牵拉系绳及其环被拉出束紧系绳的束紧环/孔眼，其中牵拉系绳被完全抽回到递送导管中并且从患者体内抽出。
图14是示出束紧系统的一个非限制性实施方案的另一个图示，并且示出了可操纵导管和牵拉系绳及其环被拉出束紧系绳的束紧环/孔眼，其中可操纵导管和牵拉系绳被完全抽回到递送导管中并且从患者体内抽出。
图15是其中束紧系绳可用于被修剪掉，或留在适当位置以被纳入向内生长的组织中的部署/安置的瓣膜的图示。
图16是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤1的一个非限制性实施方案的图示，该假体心脏瓣膜具有远端锚固接片/张力臂258，该远端锚固接片/张力臂被放置到远端瓣环下方位置中，其中远端周壁楔入到自体瓣环环上，折叠/收起的近端接片270附接到近端接片导管，并且束紧系统105-107-111-112安装到瓣膜上。
图17是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤2的一个非限制性实施方案的图示，并且示出了瓣膜主体的近侧(周壁)向内束紧/回缩以减小瓣膜主体的尺寸(直径、周长)，因此瓣膜可安置到自体瓣环中。
图18是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤3的一个非限制性实施方案的图示，并且示出了束紧件的释放和近端接片的部署，其中束紧系统在瓣膜主体上释放压缩力并允许瓣膜径向地扩张到自体瓣环中，并且其中近端接片导管将折叠/收起的近端接片展开远离瓣膜主体，以提供用于瓣膜的近侧锚固元件。
图19是示出用于正交递送的假体心脏瓣膜的递送过程的4个步骤中的步骤4的一个非限制性实施方案的图示，其中瓣膜已经部署，并且束紧系统和近端接片导管正被抽回到递送导管中并且从患者体内抽出。
图20是示出束紧系统的一个非限制性优选扭转实施方案的2个步骤中的步骤1的图示，其中瓣膜处于扩张构型，并且可操纵导管连接到多个牵拉和束紧(组合)系绳，其中每根系绳穿过套环中的单独孔眼串起并且在瓣膜的套环下方安装到瓣膜主体壁上，其中可操纵导管的旋转使系绳向前缩短并且将瓣膜主体扭转或扭绞成较窄的径向尺寸以便于插入和定位到自体瓣环中。
图21是示出束紧系统的一个非限制性优选扭转实施方案的2个步骤中的步骤2的图示，其中瓣膜处于径向压缩构型，其中可操纵导管的旋转使系绳向前缩短，从而将瓣膜主体扭转或扭绞成较窄的径向尺寸以便于将瓣膜插入和定位到自体瓣环中。
图22是示出束紧系统的一个非限制性优选束带实施方案的2个步骤中的步骤1的图示，其中瓣膜处于扩张构型，并且可操纵导管连接到辊圆柱体，其中可束紧带环绕瓣膜主体并且在瓣膜的套环下方安装到瓣膜主体壁上，其中可操纵导管的旋转使辊圆柱体旋转并且使可束紧带向前缩短以将瓣膜主体减小到较窄的径向尺寸以便于插入和定位到自体瓣环中。
图23是示出束紧系统的一个非限制性优选可束紧带实施方案的2个步骤中的步骤2的图示，其中瓣膜处于径向压缩构型，其中可操纵导管的旋转将带的一部分卷起到辊圆柱体上，并且使带向前缩短，从而将瓣膜主体减小到较窄的径向尺寸以便于将瓣膜插入和定位到自体瓣环中。
图24是根据本发明的具有远端右心室流出道(RVOT)接片、近端接片的可正交递送的经导管心脏瓣膜的侧透视图的图示。
图25是根据本发明的单系绳束紧件的侧视图的图示，该单系绳束紧件具有套在环绕周壁的可释放系绳锁上的递送导管以及用于连接到系绳锁的锚固件可安装元件。
图26是根据本发明的双系绳束紧件的侧视图的图示，该双系绳束紧件具有套在环绕周壁的可释放系绳锁上的递送导管以及用于连接到系绳锁的锚固件可安装元件。
图27是根据本发明的双系绳束紧件的侧视图的图示，该双系绳束紧件具有套在环绕周壁的可释放系绳锁上的递送导管以及用于连接到系绳锁并且连接到折叠起来的近端接片的锚固件可安装元件。
图28是处于束紧构型的瓣膜的侧视图图示。
图29是处于束紧构型的瓣膜的顶视图图示。
图30是处于扩张构型的瓣膜的顶视图图示。
图31是处于双侧束紧构型(中隔和前部，均束紧)的瓣膜的顶视图图示。
图32是安装有系绳的处于双侧扩张构型(中隔和前部，均扩张)的瓣膜的顶视图图示。
图33是安装有系绳的处于双侧束紧构型(中隔和前部，均束紧)的瓣膜的顶视图图示。
图34是示出瓣膜的椭圆的长轴R1的百分比减小和计算的周长收缩的图表。
图35是示出瓣膜的椭圆的短轴r1的百分比减小和计算的周长收缩的图表。
图36是示出瓣膜的椭圆的长轴R1的百分比减小和计算的周长收缩的图表。
图37是心脏截面的顶(最低点)视图，并且示出了各种解剖特征之间的关系。
图38(a)-(e)是以下五步骤过程的图示：(a)瓣膜递送导管与束紧设备导管一起工作以(b)将瓣膜递送到自体瓣环，(c)定位远端瓣环下方锚固接片，以及然后(d)安置并释放/松开瓣膜以实现良好密封，同时瓣膜更可预测地安置在瓣环中，以及然后(e)延伸近端瓣环下方锚固接片。
图39是一种类型的线材框架面板的图示，其示出了在水平压缩和侧向压缩之间平衡的线材框架构型。
图40是一种类型的线材框架面板的图示，其示出了相比侧向压缩更倾向于水平压缩的线材框架构型。
图41是经由股静脉经皮递送的假体三尖瓣的图示。
图42是一种类型的线材框架面板的图示，其示出了相比侧向压缩更倾向于水平压缩的线材框架构型。
图43是一种类型的线材框架面板的图示，其示出了在水平压缩和侧向压缩之间平衡的线材框架构型。
图44是束紧并安置在三尖瓣瓣环中的瓣膜100的图示，其中递送导管138通过IVC进入。
图45是在束紧并安置在三尖瓣瓣环中之后释放的瓣膜100的图示。
图46是束紧并安置在二尖瓣瓣环中的瓣膜100的图示。
图47是在束紧并安置在二尖瓣瓣环中后释放的瓣膜100的图示，其中递送导管138经由经中隔穿刺通过IVC进入。
再次参见附图，图48是根据本发明的可正交递送的经导管心脏瓣膜100的侧透视图的图示，该可正交递送的经导管心脏瓣膜具有瓣环外部支撑框架102、安装在瓣环外部支撑框架102内的可塌缩流动控制部件130、远端接片268和近端接片270。图48示出系绳105、控制线缆107和系绳孔眼111。近端壁114在此处被示出为处于扩张构型。
内部回流控制部件135包括组织覆盖物141、加强环143、不透射线标记144和鼓/回流通道135。
可塌缩(内部)流动控制部件130具有其上安装有2-4个柔性小叶258的小叶框架231，小叶框架231可沿着z轴109从圆柱形构型折叠成扁平圆柱体构型，并且可沿着竖直轴线108(y轴)压缩成缩短构型。
瓣环外部支撑框架102由形状记忆材料制成，诸如镍钛合金，例如镍钛诺，并且因此是从压缩构型开始的自扩张结构。瓣环(外部)支撑框架102具有中心(内部)通道以及在处于扩张构型时包围中心竖直轴线108的外周壁106(跨瓣环区段)，并且所述瓣环外部支撑框架102具有远侧118和近侧114。
流动控制部件130安装在瓣环外部支撑框架102内，并且被构造成允许血液沿第一方向(例如，心房到心室)流动通过瓣膜100的流入端132并且阻止血液沿与第一方向相反的第二方向流动通过瓣膜100的流出端134。
与内部流动控制部件130和外部瓣环框架102类似，内部回流控制部件135是可折叠和可压缩的。内部流动控制部件130包括小叶框架231，小叶框架231上安装有2-4个柔性小叶258。
流动控制部件130，以及因此小叶框架231，像外部框架102一样，可沿着z轴(从前到后)从圆柱形构型折叠到扁平的圆柱体构型，其中折叠线位于远侧上和近侧上，以环形状或圆柱体形状获取小叶框架231，并且将其从环压扁成双层带，即折叠在其自身上，或者像压扁成沿着两个相对侧连接的矩形或正方形的圆柱体一样。这允许外部框架102和流动控制部件130沿着z轴减小半径，直到侧壁接触或几乎接触。这还允许外部框架102和流动控制部件130保持沿着水平轴线(y轴)的半径，以使构成外部和内部的线材单元的数量最小化，这些线材单元被在装载到递送导管中所必需的折叠和/或压缩期间施加的力破坏。
内部回流控制部件135、流动控制部件130、小叶框架231和外部框架102也是竖直(y轴)可压缩的，从而减小整个瓣膜结构的高度以配合在递送导管138(在该图中未示出)的内径内。通过沿z轴折叠并且沿y轴竖直压缩，允许瓣膜结构沿着水平或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。瓣膜的长轴的长度(例如，60mm)由于其平行于递送导管的中心轴线延伸而不受这样的大瓣膜所需的大量线材框架和覆盖材料的限制。这对于现有的中心轴递送(轴向)经导管瓣膜是不可能的。与传统的轴向递送瓣膜正交的折叠压缩瓣膜的使用允许先前不可用的治疗选择。图54还示出了安装在瓣环外部支撑框架102的远侧118上的远端锚固接片268，以及安装在瓣环外部支撑框架102的近侧114上的近端锚固接片270。
在优选的实施方案中，当处于扩张构型时，瓣膜的水平x轴与中心竖直y轴成45度-135度之间的交角。
在优选的实施方案中，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。
在另一个优选的实施方案中，瓣膜具有约5mm-60mm的高度和约25mm-80mm的直径。图54还示出了引导线材护套310和引导线材311。内腔或引导球266被示出为安装在远端接片268的远端上，并具有穿过内腔266的引导线材311。尽管内腔266的内径足够大以允许引导线材311延伸穿过，但是内腔266的内径并不足够大以允许护套310延伸穿过。这允许护套310沿着引导线材311被推进，直到其抵靠内腔266的近侧向上延伸，其中在护套310上继续施加推力抵靠内腔推动，并且允许通过远端接片将瓣膜拉出递送导管，并且拉动到用于部署瓣膜的目标位置。
图49是具有带有标记144、通道135和环143的内部回流鼓137的实施方案的分解图的侧透视图的图示。图49还示出了根据本发明的安装在具有远端折叠区域120和近端折叠区域116的可折叠且可压缩的内部线材框架231内的三个小叶258尖或袋，内部231安装在外部线材框架102内，该外部线材框架具有周向附接在外部线材框架102的顶部边缘107处的套环部件103，具有远端(RVOT)接片268和近端接片270的双接片部件，以及可用于覆盖间隔元件137、覆盖套环103、覆盖外部框架102的内部和外部面和/或覆盖锚固接片268和270的生物相容性材料的任选网状部件。
心房套环103被成形为适形于自体部署位置。在三尖瓣置换术中，心房套环将具有高后壁部分以适形于自体瓣膜的中隔区域，并且将具有远端上部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，以解决(心房)右心室流出道(RVOT)瓣环下方区域上方的较大平坦空间。
图50是具有带有不透射线标记144的开放回流框架139的实施方案的分解图的侧透视图的图示。图50还示出了根据本发明的安装在可折叠且可压缩的内部线材框架231内的三个小叶尖或袋258，内部231安装在外部线材框架102内，该外部线材框架具有周向附接在外部线材框架102的顶部边缘107处的套环部件103，未覆盖的间隔件139，一对集成的独立接片部件269、270，以及网状部件226。
未覆盖的回流框架139提供瓣膜的受控回流。一旦患者不再需要回流，未覆盖的回流框架139随后就可以用后来插入的支架或覆盖物或塞子塞住。
心房套环103被成形为适形于自体部署位置。在三尖瓣置换术中，心房套环将具有高后壁部分以适形于自体瓣膜的中隔区域，并且将具有远端上部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，以解决(心房)右心室流出道(RVOT)瓣环下方区域上方的较大平坦空间。
集成接片269和271与外部框架的主体是整体构造。接片的尺寸和形状可以变化。在优选的实施方案中，RVOT接片例如269可以更长以到达肺动脉的入口(在三尖瓣置换的情况下)。
图51是根据本发明的沿着z轴(当从较宽侧观察时从前到后)处于折叠构型的可正交递送的经导管心脏瓣膜100的侧透视图的图示。图51示出了具有折叠/扁平套环103，铰链点116、120的折叠(扁平)外部框架102。图51还示出了具有标记144的折叠/扁平内部回流控制部件137，以及安装在折叠/扁平内部框架231内的小叶258。
图52是根据本发明的处于竖直压缩构型的可正交递送的经导管心脏瓣膜100的侧透视图的图示。图52示出了沿着铰链点116、120之间的折叠线，折叠(z轴)和竖直压缩(y轴)的外部框架102与折叠(z轴)和压缩(y轴)的套环103。图52还示出了内部回流控制部件137，以及安装在内部框架231内的小叶258。
图53是根据本发明的部分地装载到递送导管138中的可正交递送的经导管心脏瓣膜100的侧透视图的图示。图53示出了外部框架102、折叠套环103、内部回流控制部件137以及具有小叶258和内部框架231的流动控制部件130。
各种上文公开的和其他的特征和功能，或其替代形式，可被组合到许多其他不同的系统或应用中。本领域的技术人员随后可以做出各种目前未预见或未预料到的替代、修改、变化或改进，这些替代、修改、变化或改进中的每一者也旨在被所公开的实施方案所涵盖。
已经在本文描述了本发明的实施方案，应当注意，本领域技术人员可根据上述教导内容进行修改和变化。因此，应当理解，在所公开的本发明的特定实施方案中可以进行改变，这些改变在由所附权利要求书限定的本发明的范围和精神内。在以专利法所要求的细节和特殊性描述了本发明后，所要求的以及期望受专利证书保护的内容在所附权利要求书中阐述。

Claims (37)

1.一种具有集成束紧设备的正交递送的经导管假体心脏瓣膜，其包括：
自扩张瓣环支撑框架，所述瓣环支撑框架具有中心通道以及以扩张构型包围中心竖直轴线的外周壁，心房密封套环围绕所述外周壁的顶部边缘的至少一部分设置，所述瓣环支撑框架具有远侧和近侧，
集成束紧设备，所述集成束紧设备具有在远端处可释放地附接到所述瓣环支撑框架的细长系绳或条带，所述系绳或条带可由可操纵导管的控制柄部致动以束紧或减小所述瓣环支撑框架的所述近侧的径向尺寸；
流动控制部件，所述流动控制部件安装在所述瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过所述瓣膜的流入端并且阻止血液沿与所述第一方向相反的第二方向流动通过所述瓣膜的流出端，
瓣环下方远端锚固接片或张力臂，所述瓣环下方远端锚固接片或张力臂附接到所述周壁的远端部分并且远离所述周壁延伸，
瓣环下方近端锚固接片或张力臂，所述瓣环下方近端锚固接片或张力臂附接到所述周壁的近端部分并且远离所述周壁延伸，
其中所述瓣膜可压缩至压缩构型以便使用递送导管引入身体内以在所述身体内的期望位置处进行植入，所述压缩构型以与所述中心竖直轴线成45度-135度之间的交角沿着水平轴线取向，并且可扩张至具有与所述中心竖直轴线成45度-135度之间的交角的水平轴线的扩张构型，
其中所述瓣膜的所述压缩构型的所述水平轴线基本上平行于所述递送导管的纵向圆柱轴线。
2.如权利要求1所述的瓣膜，其中所述集成束紧设备具有两根或更多根系绳。
3.如权利要求1所述的瓣膜，其中所述集成束紧设备包括单拉系绳机构、双系绳牵拉系统、多系绳扭转机构或带束紧机构。
4.如权利要求2所述的瓣膜，其中所述系绳为编织聚乙烯、经处理的心包组织、ePTFE或镍钛诺。
5.如权利要求1所述的瓣膜，其中所述系绳或条带具有齿状物部分并且释放元件具有接合齿状物的可释放棘爪元件。
6.如权利要求1所述的瓣膜，其中第一系绳或条带附接到所述周壁的中隔侧的顶部部分，并且第二系绳或条带附接到所述周壁的所述中隔侧的底部部分。
7.如权利要求1所述的瓣膜，其中所述系绳或条带可释放地附接到所述瓣环下方近端锚固接片，并且所述近端锚固接片被配置成从抵靠所述周壁的折叠起来的位置移动到远离所述周壁折叠的扩张位置，其中所述近端锚固接片具有接片锚固元件，并且所述系绳或条带具有接片释放元件，所述接片释放元件与所述接片锚固元件协作以将所述近端锚固接片从所述折叠起来的位置移动到所述扩张位置。
8.如权利要求1所述的瓣膜，其中所述瓣环支撑框架覆盖有生物相容性材料。
9.如权利要求1所述的瓣膜，其中所述瓣环支撑框架包括多个可压缩线材单元，所述可压缩线材单元具有基本上正交于所述中心竖直轴线的取向和单元几何形状，以在所述瓣环支撑框架被配置成处于竖直压缩构型、卷起压缩构型或折叠压缩构型时使线材单元应变最小化。
10.如权利要求1所述的瓣膜，其中所述瓣环支撑框架具有下部主体部分和上部套环部分，其中处于扩张构型的所述下部主体部分形成选自漏斗、圆柱体、平锥体或圆形双曲面的形状。
11.如权利要求1所述的瓣膜，其中所述瓣环支撑框架包括编织线材或激光切割线材框架，并且所述瓣环支撑框架覆盖有生物相容性材料。
12.如权利要求1所述的瓣膜，其中所述瓣环支撑框架具有直径R为40mm-80mm、直径r为20mm-60mm并且高度为5mm-60mm的平锥体形状的侧面轮廓。
13.如权利要求1所述的瓣膜，其中所述瓣环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生物相容性材料，其选自以下情形：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并且所述外表面覆盖有织造合成聚酯材料。
14.如权利要求1所述的瓣膜，其中所述瓣环支撑框架具有顶径R1为40mm-80mm、底径R2为50mm-70mm、内径r为20mm-60mm并且高度为5mm-60mm的沙漏形状的侧面轮廓。
15.如权利要求1所述的瓣膜，其中处于扩张构型的所述瓣膜具有基本上平行于所述第一方向的中心竖直轴线。
16.如权利要求1所述的瓣膜，其中所述流动控制部件具有20mm-40mm的内径，并且心包材料的多个小叶在流入端处连接以形成圆形圆柱体并且在流出端处具有平坦的可闭合孔。
17.如权利要求1所述的瓣膜，其中所述流动控制部件用集成到所述流动控制部件中或安装到所述流动控制部件上的一个或多个纵向支撑件支撑，所述一个或多个纵向支撑件选自刚性或半刚性柱、刚性或半刚性肋、刚性或半刚性板条、刚性或半刚性面板，以及它们的组合。
18.如权利要求1所述的瓣膜，其中所述瓣环下方远端锚固接片包括线材环、线材框架、激光切割框架、集成框架区段、或支架，并且所述远端锚固接片远离所述瓣环支撑框架的所述远侧延伸约20mm-40mm。
19.如权利要求1所述的瓣膜，其中所述近端锚固接片包括线材环、线材框架、激光切割框架、集成框架区段、或支架，并且所述近端锚固接片远离所述瓣环支撑框架的所述近侧延伸约10mm-20mm。
20.如权利要求1所述的瓣膜，其还包括附接到所述瓣环支撑框架的远端上边缘的上部远端锚固接片，所述上部远端锚固接片包括线材环、线材框架、激光切割框架、集成框架区段、或支架，并且远离所述瓣环支撑框架延伸约10mm-20mm。
21.如权利要求1所述的瓣膜，其包括至少一个组织锚固件，所述至少一个组织锚固件连接到所述瓣环支撑框架以用于接合自体组织。
22.如权利要求1所述的瓣膜，其中所述外周壁包括作为第一平坦面板的前壁部分和作为第二平坦面板的后壁部分，并且其中近端折叠区域和远端折叠区域各自包括缝合接缝、织物面板、刚性铰链或没有任何线材单元的柔性织物跨距。
23.如权利要求1所述的瓣膜，其中所述瓣环支撑框架包括可压缩线材单元，所述可压缩线材单元选自由以下项组成的组：编织线材单元，激光切割线材单元，光刻产生的线材单元，3D打印线材单元，由波浪形、之字形或螺旋形的间断连接的单股线材形成的线材单元，以及它们的组合。
24.一种用于制造正交递送的经导管假体心脏瓣膜框架的方法，其包括：
使用增材或减材金属或金属合金制造来生产
自扩张瓣环支撑框架，所述瓣环支撑框架具有中心通道以及以扩张构型包围中心竖直轴线的外周壁，心房密封套环围绕所述外周壁的顶部边缘的至少一部分设置，所述瓣环支撑框架具有远侧和近侧，
集成束紧设备，所述集成束紧设备具有在远端处可释放地附接到所述瓣环支撑框架的细长系绳或条带，所述系绳或条带在所述远端处具有释放元件，所述释放元件由所述系绳或条带的近端处的控制柄部致动，所述释放元件被配置成与所述瓣环支撑框架上的锚固框架元件协作，所述系绳或条带可滑动地容纳在至少一个可滑动引导元件的内腔内，所述可滑动引导元件在靠近所述远端的位置处安装在所述周壁上，
流动控制部件，所述流动控制部件安装在所述瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过所述瓣膜的流入端并且阻止血液沿与所述第一方向相反的第二方向流动通过所述瓣膜的流出端，
附接到所述瓣环支撑框架的集成瓣环下方锚固件系统，所述锚固件系统包括在远端处附接到刚性环的细长系绳或条带，以及可滑动地附接到所述细长系绳或条带的可滑动锁定元件，
安装在所述瓣环支撑框架的所述远侧上的远端锚固接片，
安装在所述瓣环支撑框架的所述近侧上的近端锚固接片，
其中所述瓣膜可压缩至压缩构型以便使用递送导管引入身体内以在所述身体内的期望位置处进行植入，所述压缩构型以与所述中心竖直轴线成45度-135度之间的交角沿着水平轴线取向，并且可扩张至具有与所述中心竖直轴线成45度-135度之间的交角的水平轴线的扩张构型，
其中所述瓣膜的所述压缩构型的所述水平轴线基本上平行于所述递送导管的纵向圆柱轴线，
其中所述瓣膜具有约5mm-60mm的高度和约25mm-80mm的直径，
其中所述增材金属或金属合金制造是3D打印或直接金属激光烧结(粉末熔融)，并且
其中所述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。
25.如权利要求24的方法，其还包括以下步骤：
(ii)将流动控制部件安装在所述瓣膜框架内，所述流动控制部件被配置成允许血液沿着所述中心竖直轴线流动通过所述流动控制部件的流入端并且阻止血液流动通过所述瓣膜的流出端，
用心包材料或类似的生物相容性材料覆盖所述瓣膜框架的外表面。
26.一种用于压缩可植入假体心脏瓣膜以从递送导管纵向正交释放所述瓣膜的方法，其包括：
将所述可植入假体心脏瓣膜压扁、卷起或折叠成压缩构型，其中所述瓣膜的所述压缩构型的长轴基本上平行于所述递送导管的纵向圆柱轴线，
其中所述可植入假体心脏瓣膜包括瓣环支撑框架，所述瓣环支撑框架具有流动控制部件，所述流动控制部件安装在所述瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过所述瓣膜的流入端并且阻止血液沿与所述第一方向相反的第二方向流动通过所述瓣膜的流出端，
附接到所述瓣环支撑框架的集成瓣环下方锚固件系统，
安装在所述瓣环支撑框架的远侧上的远端锚固接片，
安装在所述瓣环支撑框架的近侧上的近端锚固接片。
27.如权利要求20的方法，其中使用选自由以下项组成的组的步骤将所述可植入假体心脏瓣膜卷起或折叠成压缩构型：
从所述瓣环支撑框架的一侧单侧地卷成压缩构型；
从所述瓣环支撑框架的两个相对侧双侧地卷成压缩构型；
将所述瓣环支撑框架压扁成基本上平行于所述长轴的两个平行面板，然后将扁平瓣环支撑框架卷成压缩构型；以及
沿着竖直轴线压扁所述瓣环支撑框架，以从顶部到底部减小所述瓣膜的竖直尺寸。
28.一种用于将可植入假体心脏瓣膜正交递送到身体内的期望位置的方法，所述方法包括以下步骤：
将递送导管推进到所述身体内的所述期望位置，以及通过从所述递送导管释放可扩张的假体心脏瓣膜来将所述瓣膜递送到所述身体内的所述期望位置，
其中所述瓣膜包括自扩张瓣环支撑框架，所述瓣环支撑框架具有中心通道以及以扩张构型包围中心竖直轴线的外周壁，心房密封套环围绕所述外周壁的顶部边缘的至少一部分设置，所述瓣环支撑框架具有远侧和近侧，
集成束紧设备；
流动控制部件，所述流动控制部件安装在所述瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过所述瓣膜的流入端并且阻止血液沿与所述第一方向相反的第二方向流动通过所述瓣膜的流出端，
安装在所述瓣环支撑框架的远侧上的远端锚固接片，以及
安装在所述瓣环支撑框架的近侧上的近端锚固接片，
其中所述瓣膜可束紧成具有从扩张构型减小5％-30％的椭圆形周长的束紧构型，或者具有其中所述顶部边缘的长轴在直径上减小5％-30％的束紧构型，
其中所述瓣膜可压缩至高度为5mm-10mm并且宽度为5mm-10mm的压缩构型以便使用递送导管引入所述身体内以在所述身体内的期望位置处进行植入，所述压缩构型具有以与所述第一方向成45度-135度之间的交角取向的长轴，并且可扩张至具有以与所述第一方向成45度-135度之间的交角取向的长轴的扩张构型，
其中所述瓣膜的所述压缩构型的所述长轴基本上平行于所述递送导管的纵向圆柱轴线。
29.如权利要求28所述的方法，其中从所述递送导管释放所述瓣膜选自由以下项组成的步骤：(i)使用可释放地连接到所述瓣膜的所述远侧的刚性细长推杆/拉线将所述瓣膜拉出所述递送导管，其中远离所述递送导管推进所述推杆将压缩的瓣膜拉出所述递送导管，或者(ii)使用可释放地连接到所述瓣膜的所述近侧的刚性细长推杆将所述瓣膜推出所述递送导管，其中离开所述递送导管推进所述推杆会将压缩的瓣膜推出所述递送导管。
30.如权利要求28所述的方法，其包括将附接到所述瓣膜的一个或多个组织锚固件锚固到自体组织中的附加步骤。
31.如权利要求28所述的方法，其包括将心脏瓣膜假体的所述远端锚固接片定位到右心室的右心室流出道中的附加步骤。
32.如权利要求28所述的方法，其包括将心脏瓣膜假体的所述远端锚固接片定位到右心室的右心室流出道中，以及将上部远端锚固接片定位到瓣环上方位置中的附加步骤，并且所述上部远端锚固接片在心室的方向上提供在瓣环上方的向下力，而远端锚固接片在心房的方向上提供在瓣环下方的向上力。
33.如权利要求28所述的方法，其包括使用可操纵导管沿着平行于瓣膜瓣环的平面的轴线旋转心脏瓣膜假体的附加步骤。
34.一种用于在身体内正交递送可植入假体心脏瓣膜的方法，所述方法包括以下步骤：
将引导线材的远端推进到远端位置，其中所述远端位置是肺动脉或心脏的左心室，其中所述引导线材使用股静脉通路或头臂静脉通路在患者体外开始，并通过下腔静脉或上腔静脉延伸到右心房，并且从所述右心房通过三尖瓣延伸到所述肺动脉，或者从所述右心房在经中膈通路中跨过心房间隔延伸穿过二尖瓣并进入左心室；
将递送导管在所述引导线材上方推进到目标位置，其中所述目标位置是所述三尖瓣的右心房或所述二尖瓣的左心房；
将正交压缩的可自扩张假体心脏瓣膜推进并递送到所述身体内的所述目标位置，
其中所述瓣膜的压缩构型具有基本上平行于所述递送导管的纵向圆柱轴线的长轴，
其中所述瓣膜的所述扩张构型的高度为约5mm-60mm，并且直径为约25mm-80mm，
其中所述瓣膜包括具有流动控制部件的瓣环支撑框架，所述流动控制部件安装在所述瓣环支撑框架内并且被配置成允许血液沿第一方向流动通过所述瓣膜的流入端，并且阻止血液沿与所述第一方向相反的第二方向流动通过所述瓣膜的流出端，
附接到所述瓣环支撑框架的集成瓣环下方锚固件系统，
安装在所述瓣环支撑框架的远侧上的远端锚固接片，其中所述引导线材穿过所述远端锚固接片上或所述远端锚固接片内的螺纹孔，
安装在所述瓣环支撑框架的近侧上的至少一个近端锚固接片，以及
包括细长护套的瓣膜推进工具，其中所述引导线材位于所述护套的内腔中，其中所述护套的外径大于所述远端锚固接片上的所述螺纹孔的内径，其中当沿远端方向在所述引导线材上方推进所述护套，并且所述护套的远端接触所述螺纹孔的近端表面时，所述护套赋予所述远端锚固接片的朝向远端的拉力将所述瓣膜朝远端推进穿过所述递送导管；
(iv)通过在所述引导线材上方推进所述护套来使所述瓣膜从所述递送导管部分地释放，并且将所述远端锚固接片定位在所述目标位置的期望锚固区域处，
其中所述期望锚固区域选自右心室的右心室流出道(RVOT)和二尖瓣的A1-P1前外侧连合部下方的瓣环下方区域，
其中定位所述远端锚固接片将所述瓣膜保持为与相对于所述瓣膜和所述递送导管的所述水平轴线的局部瓣环平面成至少30度的凸角，
其中使所述瓣膜部分地释放允许血液部分地围绕所述假体瓣膜流动并且通过自体小叶，并且部分地通过所述假体瓣膜的所述流动控制部件，以提供从流动通过自体小叶到完全流动通过所述假体瓣膜的逐渐血流转变；
(v)通过在所述引导线材上方推进所述护套来完成整个瓣膜从所述递送导管的释放，通过在所述心室的方向上施加向下力来将所述瓣膜安置在自体瓣环中；以及
(vi)将所述至少一个近端锚固接片安置在第二期望锚固区域处。
35.如权利要求21所述的方法，其包括将附接到所述瓣膜的一个或多个组织锚固件锚固到自体组织中的附加步骤。
36.一种用于在经导管假体心脏瓣膜的植入期间改善血液动力学流动的方法，其包括：
将递送导管推进到身体内的期望位置并且将如权利要求1所述的瓣膜递送到所述身体内的所述期望位置；
将所述瓣膜从所述递送导管部分地释放以在部分释放的瓣膜周围建立血流并且建立穿过流动控制部件的血流；
将所述瓣膜从所述递送导管完全释放，同时用定位导管或线材保持与所述瓣膜的附接，以转变为通过所述流动控制部件的增加的血流和所述瓣膜周围的减少的血流；以及
将所述瓣膜部署到最终安装位置，以转变为通过所述流动控制部件的完全血流和围绕所述瓣膜的最小血流或无血流，并且从所述瓣膜断开和抽出所述定位导管或线材。
37.如权利要求36所述的方法，其中所述远端锚固接片是在从所述瓣膜的部分释放到所述瓣膜的完全释放的转变期间定位在RVOT中的RVOT接片。
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US20220096226A1 (en) 2022-03-31
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US20210236280A1 (en) 2021-08-05
CA3138875A1 (en) 2020-11-12

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