CN108882981B - 用于防止流出阻塞的假体瓣膜 - Google Patents

用于防止流出阻塞的假体瓣膜 Download PDF

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CN108882981B
CN108882981B CN201780021798.XA CN201780021798A CN108882981B CN 108882981 B CN108882981 B CN 108882981B CN 201780021798 A CN201780021798 A CN 201780021798A CN 108882981 B CN108882981 B CN 108882981B
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valve
commissure
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兰迪·马修·莱恩
凯伦·太祖吉·王
伊恩·弗雷泽·克尔
马克·西格尔
什姆埃尔·巴奈
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Neovasc Tiara Inc
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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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • 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
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0034—D-shaped
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/006—Y-shaped
    • 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

Abstract

假体二尖瓣可以被锚固在天然二尖瓣中。所述假体二尖瓣优选具有跨越天然前小叶的整个宽度的大的前假体小叶，并且所述前假体小叶在收缩期期间远离左心室流出道移动以产生畅通的无阻塞流出路径。

Description

用于防止流出阻塞的假体瓣膜
交叉引用
本申请要求于2016年1月29日提交的美国临时专利申请号62/288,987的优先权。
本申请涉及：于2011年4月28日提交的美国专利号8,579,964；于2015年4月13日提交的美国专利公开号2015/0216655；于2015年4月21日提交的美国专利公开号2015/0257878；于2013年10月4日提交的美国专利公开号2014/0039611；于2012年11月16日提交的美国专利公开号2013/0211508；于2013年2月8日提交的美国专利公开号2014/0052237；于2013年5月5日提交的美国专利公开号2014/0155990；于2014年3月3日提交的美国专利公开号2014/0257467；以及于2014年4月1日提交的美国专利公开号2014/0343669；所述专利的全部内容为了所有目的通过引用以其整体并入本文。
发明背景
二尖瓣反流，也称为二尖瓣闭锁不全或二尖瓣关闭不全，是一种二尖瓣未正常关闭的心脏病。这导致血液从左心室通过二尖瓣向上游逆行回到心房的异常渗漏。持续性二尖瓣反流可能导致充血性心力衰竭。传统的瓣膜手术修复通常产生良好的临床结果，但需要进行心脏直视手术以及具有延长的恢复期的漫长且昂贵的住院。近来，微创手术已被开发用于将假体心脏瓣膜经由穿过患者脉管系统的导管经皮的递送到心脏。可替代地，经心尖手术(transapical procedure)被用于通过胸壁并通过心尖来引入假体。示例性的假体包括在美国专利号8,579,964中所述的假体，所述专利的全部内容为了所有目的通过引用以其整体并入本文。这些假体和递送手术似乎是有前途的，但在某些情况下，它们可能阻碍血流，导致通过假体的血流紊乱或破坏天然流动路径，从而可能导致血液动力学问题。因此，期望提供避免阻塞血液流出并维持天然流动路径和天然血液动力学的改进的装置、系统和方法。本文描述的示例性实施方式可以满足这些目标中的至少一些。
发明内容
本发明大体上涉及医疗系统、装置和方法，且更具体地涉及可用于修复瓣膜，诸如二尖瓣、心脏瓣膜或任何其他瓣膜的假体心脏瓣膜。
在第一方面，用于植入患者的天然二尖瓣中的假体心脏瓣膜包括具有扩张配置和收缩配置的径向可扩张锚固框架。所述心脏瓣膜还包括耦合至所述锚固框架的假体瓣膜。所述假体瓣膜包括各自具有自由端和固定端的多个假体瓣膜小叶(prosthetic valveleaflets)，其中所述固定端耦合至所述锚固框架，并且所述多个假体瓣膜小叶的所述自由端具有打开配置和闭合配置。在所述打开配置中，所述自由端被安置成彼此远离以允许顺行血流在其中穿过，而在所述闭合配置中所述自由端被安置成彼此相邻以基本上防止逆行血流在其中穿过。所述假体二尖瓣被配置用于以非湍流方式和圆形方向引导血流穿过所述假体瓣膜沿着患者的左心室后壁朝向心尖并沿着隔膜壁向上，直到其在收缩期期间从左心室流出道(left ventricular outflow tract)射出。
当血流流过所述假体二尖瓣和左心室并流出所述左心室流出道时，血流基本上维持动量并保存能量。血流被间接引导至心尖或隔膜壁。
所述多个假体瓣膜小叶可以包括前假体小叶，所述前假体小叶的尺寸被设定成跨越天然前小叶的整个宽度。在收缩期，所述前假体小叶可以远离所述左心室流出道偏斜以为血流提供畅通的无阻塞流出路径。
在另一方面，用于植入患者的天然二尖瓣中的假体心脏瓣膜包括具有扩张配置和收缩配置的径向可扩张锚固框架。所述假体心脏瓣膜还包括耦合至所述锚固框架的假体瓣膜，所述假体瓣膜包括各自具有自由端和固定端的多个假体瓣膜小叶。所述固定端耦合至所述锚固框架，并且所述多个假体瓣膜小叶的所述自由端具有打开配置和闭合配置。在所述打开配置中所述自由端被安置成彼此远离以允许顺行血流在其中穿过，而在所述闭合配置中所述自由端被安置成彼此相邻以基本上防止逆行血流在其中穿过。所述多个假体瓣膜小叶包括尺寸被设定成跨越天然前小叶的整个宽度的前假体小叶。在收缩期，所述前假体小叶远离所述左心室流出道偏斜以提供畅通的无阻塞流出路径。
所述假体心脏瓣膜可以被配置用于以非湍流方式引导血流穿过所述假体瓣膜并且优选地以圆形方向引导血流沿着患者的左心室后壁朝向心尖并沿着隔膜壁向上，直到血流从所述左心室流出道射出。当血流流过所述假体心脏瓣膜和左心室并流出所述左心室流出道时，血流优选地基本上维持动量并保存能量。
在任何方面，所述锚固框架可以包括被配置用于锚固在所述天然二尖瓣的纤维三角区(fibrous trigone)上或者锚固在所述前天然小叶前侧并与之相邻的任何组织上。所述锚固框架还可以包括第二前锚固耳片，所述第二前锚固耳片被配置用于锚固在所述天然二尖瓣的第二纤维三角区上或者锚固在所述前天然小叶前侧且与之相邻的任何组织上。所述锚固框架可以包括具有基本上平坦的前部和圆柱形后部的D形横截面。所述平坦的前部防止所述假体心脏瓣膜冲击所述左心室流出道，并且所述圆柱形部分接合所述天然二尖瓣的后部。所述锚固框架还可以包括一个或多个连合杆(commissure posts)以及前锚固耳片。所述一个或多个连合杆可以具有自由端和耦合至所述锚固框架的相对端。所述多个连合杆可以被耦合至所述多个假体瓣膜小叶，并且所述前锚固耳片可以被配置用于锚固在所述天然二尖瓣的纤维三角区上或者锚固在所述前天然瓣膜小叶前侧且与之相邻的任何组织上。当所述锚固框架处于所述收缩配置时，所述前锚固耳片和所述一个或多个连合杆可以彼此嵌套。所述前锚固耳片可以起源于所述锚固框架上的周向位置，并且所述一个或多个连合杆也可以起源于所述锚固框架上与所述前锚固耳片相同的周向位置。所述前锚固耳片可以起源于所述一个或多个连合杆，或者所述一个或多个连合杆可以起源于所述锚固耳片。
在另一方面，治疗患者心脏中的天然二尖瓣的方法包括提供假体二尖瓣、将所述假体二尖瓣锚固在所述天然二尖瓣中以及以非湍流方式引导血流。血流被引导以圆形方向穿过所述假体二尖瓣沿着患者的左心室后壁朝向心尖并沿着隔膜壁向上，直到血流从所述左心室流出道射出。
所述方法还可以包括当血液流过所述假体二尖瓣和左心室并流出所述左心室流出道时，基本上维持血流的动量并保存能量。引导血流可以包括将血流间接引导至心尖或隔膜壁。所述假体二尖瓣可以包括跨越所述天然前瓣膜小叶的宽度的前假体小叶，并且所述方法还可以包括在收缩期期间使所述前假体小叶远离所述左心室流出道偏斜以提供畅通的无阻塞流出路径。锚固所述假体可以包括将安置在所述假体瓣膜的前部上的前锚固耳片锚固到所述天然二尖瓣的纤维三角区或锚固到所述天然前瓣膜小叶前侧且与之相邻的组织。
在又一方面，治疗患者心脏中的天然二尖瓣的方法包括提供具有跨越天然前瓣膜小叶的宽度的前假体小叶的假体二尖瓣、将所述假体二尖瓣锚固在所述天然二尖瓣中以及在收缩期期间使处于收缩期的所述假体前小叶远离所述左心室流出道偏斜从而产生无阻塞流出路径。
所述方法还可以包括以非湍流方式引导血流穿过所述假体二尖瓣，以及以圆形方向引导血流沿着患者的左心室后壁朝向心尖并沿着隔膜壁向上，直到血流从所述左心室流出道射出。锚固所述假体可以包括将安置在所述假体瓣膜的前部上的前锚固耳片锚固到所述天然二尖瓣的纤维三角区或锚固到所述天然前小叶前侧且与之相邻的组织。
在另一方面，用于植入患者的天然二尖瓣中的假体心脏瓣膜包括具有扩张配置和收缩配置的径向可扩张锚固框架；以及耦合至所述锚固框架的假体瓣膜。所述假体瓣膜包括各自具有自由端和固定端的多个假体瓣膜小叶。所述固定端被耦合至所述锚固框架并且所述多个假体瓣膜小叶的所述自由端具有打开配置和闭合配置。在所述打开配置中所述自由端被安置成彼此远离以允许顺行血流在其中穿过，而在所述闭合配置中所述自由端被安置成彼此相邻以基本上防止逆行血流在其中穿过。所述多个假体瓣膜小叶包括尺寸被设定成跨越天然前小叶的整个宽度的前假体小叶。在收缩期，所述前假体小叶远离所述左心室流出道偏斜以提供畅通的无阻塞流出路径。
所述锚固框架可以包括被配置用于锚固在所述天然二尖瓣的前部上的前锚固耳片，并且所述天然二尖瓣的所述前部可以包括纤维三角区。所述锚固框架可以包括被配置用于锚固在所述天然二尖瓣的第二前部上的第二前锚固耳片。在一些实施方式中，所述锚固框架可以包括具有基本上平坦的前部和圆柱形后部的D形横截面，其中所述平坦的前部防止所述假体心脏瓣膜冲击所述左心室流出道，并且所述圆柱形后部接合所述天然二尖瓣的后部。在一些示例中，所述锚固框架可以包括一个或多个连合杆以及前锚固耳片，所述一个或多个连合杆具有自由端和耦合至所述锚固框架的相对端，所述一个或多个连合杆耦合至所述多个假体瓣膜小叶。
所述前锚固耳片可以被配置用于锚固在所述天然二尖瓣的前部上。在一些实施方式中，当所述锚固框架处于所述收缩配置时，所述前锚固耳片和所述一个或多个连合杆可以彼此嵌套。所述前锚固耳片起源于所述锚固框架的圆周上的周向位置，并且其中所述一个或多个连合杆也起源于所述锚固框架的所述圆周上与所述前锚固耳片相同的周向位置。所述前锚固耳片可以起源于所述一个或多个连合杆，或所述一个或多个连合杆可以起源于所述前锚固耳片。
在一些示例中，所述锚固框架还可以包括起源于所述一个或多个连合杆的多个弦式缓冲支柱(chordal bumper struts)。所述多个弦式缓冲支柱可以被配置用于使天然瓣膜下解剖结构(native sub-valvular anatomy)远离所述LVOT安置。在一些实施方式中，所述连合杆可以包括与所述连合杆的自由端相邻的锚固元件，所述锚固元件被配置用于接合递送系统。所述锚固框架还可以包括起源于所述一个或多个连合杆的多个叉骨形支柱(wishbone shaped struts)。所述多个叉骨形支柱可以被配置用于弓形地跨越相邻连合杆之间的距离。每个叉骨形支柱可以包括安置在所述叉骨形支柱的端点处或与所述叉骨形支柱的自由端相邻的锚固元件。所述锚固元件可以被配置用于接合递送导管。所述多个叉骨形支柱可以是可变形构件并且可以允许所述锚固框架在缩回到所述递送导管中时的径向压缩。所述锚固元件可以包括单螺纹连接器、多个螺纹连接器、卡扣连接器或叉状连接器。
在另一方面，用于植入患者的天然二尖瓣中的假体心脏瓣膜包括径向可扩张锚固框架、耦合至所述锚固框架的前锚固耳片以及耦合至所述锚固框架的假体瓣膜。所述径向可扩张锚固框架具有扩张配置和收缩配置以及上游端和下游端。所述径向可扩张锚固框架包括一个或多个连合杆以及邻近所述下游端耦合至所述锚固框架的前锚固耳片，所述一个或多个连合杆具有自由端和邻近所述下游端耦合至所述锚固框架的相对端。所述前锚固耳片被配置用于锚固在所述天然二尖瓣的前部上。当所述锚固框架处于所述收缩配置时，所述前锚固耳片和所述一个或多个连合杆彼此嵌套。所述假体瓣膜包括各自具有自由端和固定端的一个或多个假体瓣膜小叶，其中所述固定端耦合至所述锚固框架。所述一个或多个连合杆耦合至所述一个或多个假体瓣膜小叶。
在一些实施方式中，所述一个或多个假体瓣膜小叶的自由端可以具有打开配置和闭合配置。在所述打开配置中所述自由端可以被安置成彼此远离以允许顺行血流在其中穿过，而在所述闭合配置中所述自由端可以被安置成彼此相邻以基本上防止逆行血流在其中穿过。所述一个或多个假体瓣膜小叶可以包括尺寸被设定成跨越两个天然纤维三角区之间的天然前瓣膜小叶的宽度的前假体小叶。在收缩期，所述前假体小叶可以远离所述左心室流出道偏斜，以提供畅通的无阻塞流出路径。所述天然二尖瓣的前部可以包括纤维三角区。
在一些示例中，所述锚固框架可以包括被配置用于锚固在所述天然二尖瓣的第二前部上的第二前锚固耳片。附加地或作为替代，所述锚固框架可以包括具有基本上平坦的前部和圆柱形后部的D形横截面。所述平坦的前部可以防止所述假体心脏瓣膜冲击所述左心室流出道，并且所述圆柱形部分可以接合所述天然二尖瓣的后部。
所述前锚固耳片可以起源于所述锚固框架的圆周上的周向位置，并且所述一个或多个连合杆也可以起源于所述锚固框架的所述圆周上与所述前锚固耳片相同的周向位置。在一些示例中，所述前锚固耳片可以起源于所述一个或多个连合杆，或者所述一个或多个连合杆可以起源于所述前锚固耳片。
在另一方面，治疗患者心脏中的天然二尖瓣的方法包括：提供假体二尖瓣，所述假体二尖瓣具有跨越天然前瓣膜小叶宽度的前假体小叶；将所述假体二尖瓣锚固在所述天然二尖瓣中；以及在收缩期期间，使处于收缩期的所述假体前小叶远离左心室流出道偏斜，从而产生无阻塞流出路径。将所述假体二尖瓣锚固在所述天然二尖瓣中可以包括将安置在所述假体瓣膜的前部上的前锚固耳片锚固到所述天然二尖瓣的前部。在一些示例中，所述天然二尖瓣的所述前部可以包括纤维三角区。
所述方法可以包括使所述假体二尖瓣从收缩配置径向扩张至扩张配置，其中径向扩张所述假体二尖瓣可以包括使一个或多个前锚固耳片远离一个或多个连合杆内的嵌套位置扩张。所述方法可以包括使所述假体二尖瓣从收缩配置径向扩张至扩张配置，其中径向扩张可以包括使一个或多个后锚固耳片远离一个或多个连合杆内的嵌套位置扩张。在一些示例中，锚固所述假体二尖瓣可以包括使递送系统上的致动器机构在第一方向上致动，这可以包括使鞘套导管远离所述假体二尖瓣移动以移除约束，从而允许所述假体二尖瓣扩张。所述方法还可以包括使所述致动器机构在与所述第一方向相反的第二方向上致动，这可以包括使鞘套导管朝向所述假体二尖瓣移动以提供约束，从而迫使所述假体二尖瓣被压缩。在一些示例中，使所述致动器机构在所述第一方向上致动可以包括使钟形导管远离锚固导管移动以移除约束，从而允许释放连合锚固件。所述连合锚固件可以包括将所述假体二尖瓣的框架接合到所述递送系统的锚固元件。使所述致动器机构在所述第二方向上致动可以包括使钟形导管朝向所述锚固导管移动以提供捕获或限制所述连合锚固件的约束。提供捕获或限制所述连合锚固件的约束可以包括在所述连合锚固件上方可释放地滑动制动元件(retaining element)。此外，使所述致动器机构致动可以包括在所述锚固导管上方移动鞘套导管，从而施加约束，这可以包括允许连合锚固件被压缩。所述连合锚固件可以包括挠性锚固元件，所述挠性锚固元件可以将所述假体二尖瓣的框架接合到所述递送系统。
在另一方面，治疗患者心脏中的天然二尖瓣的方法包括：提供假体二尖瓣，所述假体二尖瓣耦合至具有上游端和下游端的径向可扩张锚固框架；将所述径向可扩张锚固框架从收缩配置扩张到扩张配置；将所述假体二尖瓣锚固在所述天然二尖瓣中，其中所述前锚固耳片锚固在所述天然二尖瓣的前部上；以及使所述前锚固耳片远离所述一个或多个连合杆内的嵌套位置径向扩张。所述径向可扩张锚固框架包括一个或多个连合杆以及邻近所述下游端耦合至所述锚固框架的前锚固耳片，所述一个或多个连合杆具有自由端和邻近所述下游端耦合至所述锚固框架的相对端。所述天然二尖瓣的所述前部可以包括纤维三角区。在一些示例中，径向扩张所述锚固框架可以包括使所述一个或多个连合杆远离所述前锚固耳片内的嵌套位置扩张。
所述假体二尖瓣可以包括前假体小叶，并且所述方法可以包括跨越两个天然纤维三角区之间的天然前瓣膜小叶的宽度、使所述前假体小叶远离左心室流出道偏斜，以及通过所述前假体小叶的所述偏斜产生无阻塞流出路径。
在另一方面，用于将假体递送至目标治疗区域的递送系统包括：内导丝导管，其具有近端、远端以及在所述近端与所述远端之间延伸的管腔，所述管腔的尺寸被设定成可滑动地接纳导丝；耦合至所述导丝导管的挠性膨胀端头(flexible dilating tip)，所述膨胀端头具有锥形且挠性的自膨胀边缘；可滑动地安置在所述内导丝导管上方的鞘套导管，所述鞘套导管具有近端和远端；可操作地耦合至所述鞘套导管的所述近端的致动器机构。所述致动器机构在第一方向上的致动使所述鞘套导管远离所述膨胀器端头移动，从而从所述假体移除约束并允许所述假体扩张。此外，所述致动器机构在与所述第一方向相反的第二方向上的致动使所述鞘套导管移动成与所述膨胀器端头接合，从而将所述假体封闭在其中。
所述系统可以包括固定地安置在所述导丝导管上的静止锚固导管，所述锚固导管具有与所述锚固件导管的远端相邻且被配置用于接合所述假体的锚固件元件。在一些示例中，钟形导管可以可滑动地安置在所述锚固导管上方。所述钟形导管可以具有被安置成与所述钟形导管的远端相邻的钟形元件，并且所述钟形元件可以将假体约束成与所述锚固件导管接合。所述锚固导管可以具有与所述锚固件导管的所述远端相邻的挠性叉型锚固件元件(flexible prong type anchor element)，所述挠性叉型锚固件元件被配置用于接合所述假体。所述鞘套导管可以可滑动地安置在所述锚固导管上方。具体地，所述鞘套导管的远端的推进可以使所述挠性叉型锚固件元件收缩成与所述假体接合。
在一些实施方式中，静止钟形导管可以固定地安置在所述锚固导管上方。所述钟形导管可以具有被安置成与所述钟形导管的远端相邻的钟形元件，并且所述钟形元件可以使所述假体从所述锚固件导管脱离。在一些实施方式中，所述系统可以包括可旋转地安置在所述导丝导管上方的钟形导管。所述钟形导管可以具有被安置成与所述钟形导管的远端相邻的内螺纹钟形元件，并且所述螺纹钟形元件可以将假体约束成接合状态。第二致动器机构可以可操作地耦合至所述钟形导管的近端。所述第二致动器机构在第一方向上的致动可以将所述假体耦合至所述钟形导管，从而向所述假体提供约束，并且所述第二致动器机构在与所述第一方向相反的第二方向上的致动可以将所述假体与所述钟形导管解耦，从而从所述假体移除约束。所述系统可以包括可旋转地安置在所述导丝导管上方的旋转扭矩导管。所述扭矩导管可以具有与所述扭矩导管的远端相邻且被配置用于传递扭矩的主动齿轮元件。多个旋转螺纹连接器导管可以被可旋转地安置成与所述扭矩导管相邻。所述螺纹连接器导管可以各自具有与每个螺纹连接器导管的远端相邻的从动齿轮元件，以及与每个螺纹连接器导管的所述远端相邻的螺纹插口(threaded socket)。所述从动齿轮元件的尺寸可以被设定成与所述主动齿轮元件啮合并接收扭矩，并且所述螺纹插口可以被配置用于将所述假体约束成接合状态。第二致动器机构可以被可操作地耦合至所述扭矩导管的近端。所述第二致动器机构在第一方向上的致动可以将所述假体耦合至所述螺纹连接器导管并且所述第二致动器机构在与所述第一方向相反的第二方向上的致动可以将所述假体与所述螺纹连接器导管解耦。
在任何方面，所述方法还可以包括将所述假体二尖瓣从收缩配置径向扩张到扩张配置。径向扩张所述假体可以包括使前锚固耳片远离具有连合杆的嵌套配置扩张。
在与所附附图相关的以下描述中更详细地描述了这些实施方式和其他实施方式。
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本发明的新颖特征在随附权利要求书中具体阐述。通过参考以下对其中利用到本发明原理的说明性实施方式加以阐述的详细描述和附图，将会获得本发明的特征和优点的更好的理解；在这些附图中：
图1描绘了前视图中的解剖心脏。
图2示出了图1的横截面以及心脏的内部解剖结构，包括左心室流出道(LVOT)和假体二尖瓣。
图3描绘了后视图中的解剖心脏。
图4示出了图3的横截面以及心脏的内部解剖结构，特别是二尖瓣和主动脉瓣下侧的空间。
图5图示了被配置用于避免LVOT阻塞的假体二尖瓣的实施方式。
图6描绘了被配置用于避免LVOT阻塞的三小叶假体二尖瓣的流入视图。
图7描绘了被配置用于避免LVOT阻塞的三小叶假体二尖瓣的流出视图。
图8A示出了鸭嘴瓣膜(duck-bill valve)形式的单小叶假体二尖瓣的流出视图。
图8B示出了双小叶假体二尖瓣的流出视图。
图8C描绘了处于打开位置的前单小叶假体二尖瓣的流出视图。
图8D示出了处于闭合位置的前单小叶假体二尖瓣的流出视图。
图8E示出了具有大的前小叶的三小叶假体二尖瓣的流出视图。
图8F示出了四小叶假体二尖瓣的流出视图。
图9示出了假体二尖瓣框架的框架平铺图案。
图10示出了具有弦式缓冲支柱的假体二尖瓣框架的框架平铺图案。
图11示出了具有弦式缓冲支柱和叉骨形支柱的假体二尖瓣框架的框架平铺图案。
图12示出了具有叉骨形支柱的假体二尖瓣框架的框架平铺图案。
图13图示了具有叉骨形支柱并且被塑造成避免LVOT阻塞的假体二尖瓣的实施方式。
图14图示了锚固到递送系统的具有叉骨形支柱的假体二尖瓣的实施方式。
图15A示出了递送系统和叉骨形支柱锚固变体的实施方式，其中多个螺纹连接器处于连接状态。
图15B示出了递送系统和叉骨形支柱锚固变体的实施方式，其中多个螺纹连接器处于分离状态。
图16A示出了递送系统和叉骨形支柱锚固变体的实施方式，其中分裂螺纹连接器处于连接状态。
图16B示出了递送系统和叉骨形支柱锚固变体的实施方式，其中分裂螺纹连接器处于分离状态。
图17A示出了递送系统和叉骨形支柱锚固方法的实施方式，其中挠曲销连接器处于连接状态。
图17B示出了递送系统和叉骨形支柱锚固方法的实施方式，其中挠曲销连接器处于分离状态。
图18A示出了递送系统和叉骨形支柱锚固方法的实施方式，其中挠性卡扣连接器处于连接状态。
图18B示出了递送系统和叉骨形支柱锚固方法的实施方式，其中挠性卡扣连接器的内部视图处于连接状态。
图18C示出了递送系统和叉骨形支柱锚固方法的实施方式，其中挠性卡扣连接器的内部视图处于分离状态。
图19A示出了递送系统和叉骨形支柱锚固方法的实施方式，其中锚形连接器的内部视图处于连接状态。
图19B示出了递送系统和叉骨形支柱锚固方法的实施方式，其中锚形连接器未被约束以允许分离。
图20A描绘了处于闭合配置中的递送系统的实施方式，其中假体二尖瓣装载在内部。
图20B描绘了处于部分打开配置中的递送系统的实施方式，其中假体二尖瓣装载在内部并且正在展开。
图20C描绘了处于基本打开配置中的递送系统的实施方式，其中假体二尖瓣装载在内部并且处于中等展开状态。
图20D描绘了处于基本打开配置中的递送系统的实施方式，其中假体二尖瓣被装载并且接近被释放。
图20E描绘了处于完全打开配置中的递送系统的实施方式，其中假体二尖瓣装载在内部，即将最终展开。
图20F描绘了释放后的假体二尖瓣的实施方式。
图21A-图21C示出了具有开槽锚固机构的递送系统的实施方式，所述开槽锚固机构可以容纳锚固的叉骨形支柱。
图22示出了具有开槽锚固机构的递送系统的实施方式的放大视图，所述开槽锚固机构可以容纳锚固的叉骨形支柱。
图23示出了具有开槽锚固机构的递送系统的分解视图，所述开槽锚固机构可以容纳锚固的叉骨形支柱。
图24A-图24C示出了具有挠性连接器锚固机构的递送系统的实施方式，所述挠性连接器锚固机构可以容纳销钉叉骨形支柱。
图25描绘了具有挠性连接器锚固机构的递送系统的实施方式的分解视图，所述挠性连接器锚固机构可以容纳销钉叉骨形支柱。
图26A描绘了具有滑动连接器锚固机构的递送系统的实施方式的分解视图，所述滑动连接器锚固机构可以容纳挠性卡扣的叉骨形支柱。
图26B描绘了具有滑动连接器锚固机构的递送系统的实施方式的放大视图，所述滑动连接器锚固机构可以容纳挠性卡扣的叉骨形支柱。
图27描绘了具有单个螺钉连接器锚固机构的递送系统的实施方式的分解视图，所述单个螺钉连接器锚固机构可以容纳分裂螺纹叉骨形支柱。
图28示出了具有单个螺钉连接器锚固机构的递送系统的实施方式的放大视图，所述单个螺钉连接器锚固机构可以容纳分裂螺纹叉骨形支柱。
图29示出了具有多个螺钉连接器锚固机构的递送系统的实施方式的分解视图，所述多个螺钉连接器锚固机构可以容纳螺纹叉骨形支柱。
图30示出了具有多个螺钉连接器锚固机构的递送系统的实施方式的同心导管的分解视图，所述多个螺钉连接器锚固机构可以容纳螺纹叉骨形支柱。
图31示出了在可以容纳螺纹叉骨形支柱的递送系统的实施方式的末端处的太阳齿轮和多个螺钉连接器锚固机构的放大视图。
图32示出了心脏中的湍流血流。
图33示出了心脏中的非湍流血流。
图34图示了以非湍流方式引导心脏中的血液的假体二尖瓣。
图35图示了假体瓣膜的透视图。
图36A图示了假体瓣膜的心房裙部(atrial skirt)。
图36B图示了假体瓣膜的俯视图。
图37图示了假体瓣膜的平铺图案。
图38图示了假体瓣膜的透视图。
图39A图示了假体瓣膜的前视图。
图39B图示了假体瓣膜的俯视图。
图40图示了假体瓣膜的展开。
图41图示了假体瓣膜的侧视图。
图42图示了结合的连合杆和锚固耳片。
图43A-图43B图示了未扩张的和扩张的锚固耳片。
图43C图示了扩张的锚固耳片的平铺图案。
图44示出了D形假体。
图45示出了假体瓣膜的侧视图。
图46示出了具有四个小叶和四个锚固件的假体瓣膜的俯视图。
图47示出了具有三个小叶和三个锚固件的假体瓣膜的俯视图。
图48示出了假体瓣膜的平铺图案。
图49示出了重叠在锚固耳片上方的天然瓣膜小叶。
图50示出了其中具有嵌套的连合杆的锚固耳片的倒置。
图51示出了具有位于天然前小叶附近的两个锚固件和在后部中缺乏相似锚固件的扩张区的实施方式。
图52示出了假体瓣膜的平铺图案。
图53示出了假体瓣膜的另一平铺图案。
图54示出了假体瓣膜的透视图。
图55示出了与主动脉瓣相邻的二尖瓣。
图56示出了在扩张配置中嵌套在连合杆中的又一锚固耳片。
图57示出了在扩张配置中嵌套在连合杆中的锚固耳片。
图58示出了在收缩配置中嵌套在连合杆中的锚固耳片。
图59示出了可变的支柱厚度。
具体实施方式
现在将参考附图来描述所公开的装置、递送系统和方法的具体实施方式。本详细描述中的内容并不旨在暗示任何特定组件、特征或步骤对于本发明而言是不可或缺的。
如本文所用的，相同的数字指代相同的元件。
图1提供了解剖心脏的图示，本文由心脏的前面10来表示。还呈现了解剖心脏的各种结构的前视图。示出了在所述前面10的左侧(观察者的左侧)的上腔静脉50、右心房40和右心室20，其中上侧结构和下侧结构被右冠状动脉120分开。横截面线A-A将心脏解剖结构分为侧面部分，并在图2中进一步讨论。移至心脏右侧(观察者的右侧)，在肺动脉干90的上侧位置可以看到主动脉60的前视图。肺动脉干90下方为左心房70和左心耳80。左心耳80下方且在左心耳的左侧和右侧(观察者的左侧和右侧)分别是左前降支冠状动脉100和中间冠状动脉110。最后，所有先前提及的元件下侧为左心室30。
图2示出了沿着横截面A-A切割心脏的前面10(如图1所示)之后的心脏的内部结构。横截面A-A由表示切割平面的阴影区130限定。从最上侧的元件开始，描绘了主动脉140在后面。在主动脉140下后方的是右心房180。示出了左心房150的内部视图，显露了假体二尖瓣210在植入后可以位于何处。还可以看到假体二尖瓣210的流入区域220和假体二尖瓣的流出区域230。假体二尖瓣210的前面170可以与左心室流出道200(LVOT)的区190相邻。前锚固耳片240可以位于避免LVOT200堵塞的位置。当心缩发生且血液从假体二尖瓣210下方朝向LVOT200分流时，由于区190的大面积，可能存在直接通向主动脉140的宽敞通道。这种配置可以使LVOT 200免于被外来的假体大体积或突出物阻塞。
假体二尖瓣可以包括一个或多个耳片。假体二尖瓣可以包括1、2、3、4、5、6、7、8、9、10个或多于10个耳片。后锚固耳片250可以位于假体二尖瓣210的前锚固耳片240的对面。后锚固耳片250可以邻接天然解剖结构并且抵靠后心室架区域(posterior ventricularshelf region)160，该后心室架区域形成于心室和后二尖瓣环的接合处的心室内(更清楚的描绘参见图4)。第三锚固耳片在图2的描绘中被遮蔽。通常由从各个物种(如牛、猪或羊物种)收获的化学保存的心包组织构建的瓣膜小叶260可以位于前锚固耳片240与后锚固耳片250之间。从图5开始提供了与假体二尖瓣210相关的进一步细节。
图3提供了解剖心脏的图示，本文由心脏的后面265来表示。还呈现了解剖心脏的各种结构的后视图。从最上侧的元件开始，上腔静脉380的后面与主动脉370的后面相邻并在肺动脉干390后面的上方。其次还描绘了右心房270、左心耳280(出现在观察者的左侧)、左心房340、右肺静脉350和左肺静脉360(出现在观察者的右侧)。横截面线B-B将呈现的心脏解剖结构分为上侧部分和下侧部分，并在图4中进一步讨论。冠状动脉和相关分支包括左冠状动脉的左缘支290、旋支300、后左心室分支310，以及右冠状动脉的后室间分支320。最后，元件的最下侧位置为心尖330。
图4示出了沿着横截面B-B切割心脏的后面256(如图3所示)之后的心脏的内部结构。横截面B-B由表示切割平面的阴影区400限定。从图的顶部开始，后心室架470与后二尖瓣小叶450的固定端相邻并通过组织与其连接。如本文所述，这种架可以为假体二尖瓣的后锚固耳片提供位置。后腱索455的连拱位于与后二尖瓣小叶450相邻并通过组织与其连接，从而沿着小叶的自由边缘找到该腱索的插入点。后腱索455的固定端在前外侧乳头肌430和后内侧乳头肌440两者中找到插入点。乳头肌430和440充当由所述腱索提供的栓系效应的肌肉支撑基底，从而在处于动态张力下时跨越小叶自由边缘插入部与乳头肌插入部之间的距离。与前二尖瓣小叶460直接相对的是后二尖瓣小叶450。在收缩期期间，后二尖瓣小叶450和前二尖瓣小叶460在它们的自由边缘彼此抵靠关闭时连通，以便防止逆行血流进入左心房。前二尖瓣小叶460的自由边缘也与前腱索465的连拱相邻并通过组织与其连接，前腱索465也在前外侧乳头肌430和后内侧乳头肌440两者中找到固定端插入点，从而反映后小叶的索结构。
前二尖瓣小叶460的固定端与主动脉瓣膜500的流入物直接相邻并通过组织与其连接。这种相邻性通常被称为主动脉-二尖瓣连续性(aorto-mitral continuity)。正是在这个区域中出现了流出道阻塞的风险，因此需要旨在使LVOT阻塞最小化的本发明。前二尖瓣小叶460的固定端侧面是称为纤维三角区的致密软骨组织区域，其充当整个心脏的骨骼状结构。隔前纤维三角区480和前外侧纤维三角区490由三角形表示，该三角形划分了瓣膜展开期间假体二尖瓣的前锚固耳片(未示出)可以邻接在其上的着陆区。作为参考，在图的底部示出了三尖瓣410和主动脉420。
图5透视地图示了本发明，示出了具有大的前小叶的假体二尖瓣510(210，如图2所示)。假体可以包括心房区域、环形区域、瓣膜区域和锚固区域。框架525可以提供结构装置并且由图5中的虚线示出，整个假体瓣膜可以建立在该结构装置上。该框架可以是镍钛诺框架。框架525可以层叠在提供优异密封性能的各种生物相容性织物内。生物相容性织物可以包括聚酯、尼龙或如本领域技术人员已知的任何其他生物相容性织物。可以使用医用级缝线将各种织物缝合到框架525上以构建假体。假体的心房区域可以包括心房裙部520，该心房裙部520充当凸缘并允许瓣膜的流入区域(220，如图2所示)在左心房底部上方与天然二尖瓣环对齐并抵靠天然二尖瓣环进行密封。心房裙部520可以横贯假体瓣膜的流入区域(220，如图2所示)的整个圆周，并且可以与同样横贯假体瓣膜圆周的环形区域530连通并连接至该环形区域530。在本表示中，以背对观察者且向右朝向的方式示出了假体瓣膜的前表面。如此，前小叶580以背对且向右朝向的方式示出。一个或多个瓣膜小叶可以形成假体的瓣膜区域。小叶可以包括前小叶580、隔后小叶570和后外侧小叶590。如本文所述，前小叶580可以包括前小叶流入表面。如本文所述，隔后小叶570可以包括隔后小叶流入表面。如本文所述，后外侧小叶590可以包括后外侧小叶流入表面。
多个小叶中的一个或多个可以包括化学保存的心包组织。可以用促进聚合物交联、使组织对人呈惰性和生物相容性和/或使组织准备进行进一步灭菌处理的化学防腐剂来处理化学保存的心包组织。小叶组织可以来源于牛、猪或羊来源，但不应限于前述物种。在闭合配置中，前小叶580、隔后小叶570和后外侧小叶590中的每一个的自由端可以在小叶接合的三接点600处汇合。相反地，如本文所述，每个小叶的固定端可以被缝合到瓣膜的环形区域，同时缝合到在提供增加的结构弹性的特定位置处的下一相邻小叶。虽然图5示出了三个小叶，但是假体二尖瓣可以包括任何数目的小叶。例如，假体二尖瓣可以包括1、2、3、4、5、6、7、8、9、10个或多于10个小叶。
每个小叶可以通过连合缝合衬垫在连合附接点处连续地连接到下一相邻小叶。因此，假体二尖瓣可以包括一个或多个连合附接点和一个或多个连合缝合衬垫。具体地，隔后小叶570和前小叶580可以被连接在一起并且通过隔前连合缝合衬垫560附接到隔前连合附接点550，前小叶580和后外侧小叶590可以被连接在一起并且通过前外侧连合缝合衬垫615附接到前外侧连合附接点625，并且后外侧小叶590和隔后小叶570可以被连接在一起并通过后连合缝合衬垫640附接到后连合附接点645。虽然图5示出了三个连合附接点和三个连合缝合衬垫，但是假体二尖瓣可以包括任何数目的连合附接点。例如，假体二尖瓣可以包括1、2、3、4、5、6、7、8、9、10个或多于10个连合附接点和1、2、3、4、5、6、7、8、9、10个或多于10个连合缝合衬垫。
一个或多个连合锚固件可以远离瓣膜延伸并进入来自每个连合附接点的自由空间。例如，隔前连合锚固件555可以从隔前连合附接点550延伸，前外侧连合锚固件620可以从前外侧连合附接点625延伸，并且后连合锚固件650可以从后连合附接点645延伸。如本文所述，连合锚固件中的每个可以包括装置，假体可以通过所述装置锚固并连接到合适的递送系统。多个连合锚固件中的每一个的形状通常可以类似于锚或半月的形状，但是本领域技术人员将认识到，这种元件可以暗示允许多个连合锚固件被有效锚固到可能的递送系统的任何形状。虽然图5示出了三个连合锚固件，但是假体二尖瓣可以包括任何数目的连合锚固件。例如，假体二尖瓣可以包括1、2、3、4、5、6、7、8、9、10个或多于10个连合锚固件。
锚固耳片中的一个或多个远离连合附接点中的每个延伸(在该示例中是朝向瓣膜延伸)。每个锚固耳片可以包括与连合附接点连通的固定端和朝向心房裙部延伸并且提供锚固装置的自由端，假体可以通过该锚固装置将自身附接到天然解剖结构。前锚固耳片通常可以抵靠二尖瓣的天然纤维三角区，而后锚固耳片通常可以抵靠二尖瓣的后心室架。隔前三角形锚固耳片540(240，如图2所示)可以在固定端处连接至隔前连合附接点550，并且可以具有抵靠隔前纤维三角区(480，如图4所示)的自由端545。前外侧三角形锚固耳片610(260，如图2所示)可以在固定端处连接至前外侧连合附接点625，并且可以具有被带入为抵靠前外侧纤维三角区(490，如图4所示)的自由端(在该视图中未示出)。最后，后锚固耳片630(250，如图2所示)可以在固定端处连接至后连合附接点645，并且可以具有抵靠后架(470，如图4所示)的自由端635。虽然图5示出了三个锚固耳片，但是假体二尖瓣可以包括任何数目的锚固耳片。例如，假体二尖瓣可以包括1、2、3、4、5、6、7、8、9、10个或多于10个锚固耳片。
图6图示了假体二尖瓣(510，如图5所示)的流入视图660。通过从瓣膜流入的前面690(D形的平坦侧)沿顺时针方向追踪路径直到抵达瓣膜流入的后面700(D形的弯曲部分)，然后再次返回到瓣膜流入的前面690，可以充分地理解假体二尖瓣的近似“D”形。心房裙部(520，如图5所示)的前部670与瓣膜流入的前面690相邻。心房裙部的后部680与瓣膜流入的后面700相邻。多个框架支柱740可以周向环绕瓣膜流入。框架支柱740可以为心房裙部的前部670和后部680两者提供结构支撑以及与假体二尖瓣的环形区域(530，如图5所示)的附接装置。还描绘了后外侧小叶流入表面710(对应于后外侧小叶590，如图5所示)、前小叶流入表面720(对应于前小叶580，如图5所示)以及隔后小叶流入表面730(对应于隔后小叶570，如图5所示)。还示出了后锚固耳片自由端635、前外侧三角形锚固耳片自由端610和隔前三角形锚固耳片自由端545。
图7图示了假体二尖瓣(510，如图5所示)的流出视图750。当隔后小叶770(570，如图5所示)的接合面(coaptation surface)775、后外侧小叶760(590，如图5所示)的接合面765以及前小叶780(580，如图5所示)的接合面785通过瓣膜闭合而彼此接触时，在收缩期期间可以形成如前所述的小叶接合的三接点(600，如图5所示)。前述的连合部和锚固耳片也在本流出视图750中描绘，并由后锚固耳片800(630，如图5所示)和相关联的后连合锚固件805(650，如图5所示)、隔前三角形锚固耳片810(540，如图5所示)和相关联的隔前连合锚固件815(555，如图5所示)以及前外侧三角形锚固耳片790(610，如图5所示)和相关联的前外侧连合锚固件795(620，如图5所示)识别。
图8A图示了具有单个单小叶830的假体二尖瓣(510，如图5所示)的实施方式，该单个单小叶830呈鸭嘴瓣膜形式并呈现在流出视图820中。鸭嘴式瓣膜可以通过在单个单小叶830的近似中心处制造切口840而产生，这可以产生小叶接合边缘，由此所得的瓣膜可以在该小叶接合边缘上起作用。假体二尖瓣还可以包括瓣膜流入的前面690、瓣膜流入的后面700、前外侧三角形锚固耳片790和相关联的前外侧连合锚固件795、后锚固耳片800和相关联的后连合锚固件805或隔前三角形锚固耳片810和相关联的隔前连合锚固件815中的一种或多种。
图8B图示了包括二小叶或双小叶配置的假体二尖瓣(510，如图5所示)的实施方式，其同样在流出视图850中示出。双小叶配置可以通过包括前小叶870和后小叶860的一对小叶来实现，这一对小叶可以在收缩期期间在小叶接合边缘880处汇合在一起。假体二尖瓣还可以包括瓣膜流入的前面690、瓣膜流入的后面700、前外侧三角形锚固耳片790和相关联的前外侧连合锚固件795、后锚固耳片800和相关联的后连合锚固件805和/或隔前三角形锚固耳片810和相关联的隔前连合锚固件815中的一种或多种。
图8C和图8D示出了从流出视图890观察的单小叶假体二尖瓣(510，如图5所示)的实施方式，该假体二尖瓣包括在收缩期期间可能能够跨越整个瓣膜口并抵靠瓣膜流入的后面700进行密封的一个大的前小叶900。在打开配置中，后流出区域910可以允许顺行血液从左心房通过瓣膜并流入左心室。假体二尖瓣还可以包括瓣膜流入的前面690、瓣膜流入的后面700、前外侧三角形锚固耳片790和相关联的前外侧连合锚固件795、后锚固耳片800和相关联的后连合锚固件805或隔前三角形锚固耳片810和相关联的隔前连合锚固件815中的一种或多种。
图8D示出了在闭合配置920中，大的前小叶900已经闭合并且所述前小叶900的后覆盖区域925已经抵靠出现在瓣膜流入的后面700上的小叶接合边缘930而密封。假体二尖瓣还可以包括瓣膜流入的前面690、瓣膜流入的后面700、前外侧三角形锚固耳片790和相关联的前外侧连合锚固件795、后锚固耳片800和相关联的后连合锚固件805或隔前三角形锚固耳片810和相关联的隔前连合锚固件815中的一种或多种。
图8E图示了假体二尖瓣(510，如图5所示)的实施方式，该假体二尖瓣包括三小叶配置940，并且由在本文描述为大前小叶960、小后外侧小叶970和小隔后小叶950的多个小叶形成。在收缩期期间，所述小叶被迫闭合并沿着小叶接合边缘980彼此接触。假体二尖瓣还可以包括瓣膜流入的前面690、瓣膜流入的后面700、前外侧三角形锚固耳片790和相关联的前外侧连合锚固件795、后锚固耳片800和相关联的后连合锚固件805或隔前三角形锚固耳片810和相关联的隔前连合锚固件815中的一种或多种。
图8F描绘了从流出视图观察并包括四小叶配置990的假体二尖瓣(510，如图5所示)的实施方式。瓣膜可以由在本文描述为后小叶1000、隔小叶1010、前小叶1020和外侧小叶1030的多个小叶形成。在收缩期期间，小叶可以被迫闭合并沿着小叶接合边缘1040彼此接触。假体二尖瓣可以包括一个或多个锚固耳片和连合锚固件。与隔前三角形锚固耳片810和前外侧三角形锚固耳片以及相应的连合锚固件(815隔前连合锚固件和795前外侧连合锚固件)一起，可以存在隔后锚固耳片1060和后外侧锚固耳片1050，以及相应的隔后连合锚固件1065和后外侧连合锚固件1055。假体二尖瓣还可以包括瓣膜流入的前面690、瓣膜流入的后面700、前外侧三角形锚固耳片790和相关联的前外侧连合锚固件795、后锚固耳片800和相关联的后连合锚固件805或隔前三角形锚固耳片810和相关联的隔前连合锚固件815中的一种或多种。
图9描绘了框架平铺图案1070，其为机械工具(诸如聚焦激光器、刨槽机、立铣刀或如本领域技术人员已知的任何其他机械工具)可以在假体瓣膜成型过程中遵循的工具路径的表示。框架可以由材料的管状备料切割而来。例如，框架可以由镍钛诺的管状备料切割而来。装置可以包括先前讨论的几个特征(在图5中介绍)，诸如前外侧连合锚固件795(图5的元件620)、隔前连合锚固件815(图5的元件555)和后连合锚固件805(图5的元件650)。词组“支柱形式”是指框架平铺图案中图示的元件，因此框架的元件可以是未变形的(即，通过本领域技术人员已知的冶金热处理来定形)并且通常类似于矩形构件或“支柱”。图9中描绘了关于连合结构及其与锚固耳片的空间关系的附加细节。这种平铺图案表示图5中描绘的假体二尖瓣的实施方式。
假体二尖瓣可以包括一个或多个附接轨道、一个或多个连合部、一个或多个连合附接孔、一个或多个连合槽以及一个或多个连合接合处。假体二尖瓣可以包括1、2、3、4、5、6、7、8、9、10个或多于10个附接轨道；1、2、3、4、5、6、7、8、9、10个或多于10个连合部；1、2、3、4、5、6、7、8、9、10个或多于10个连合附接孔；1、2、3、4、5、6、7、8、9、10个或多于10个连合槽；以及1、2、3、4、5、6、7、8、9、10个或多于10个连合接合处。
前外侧连合锚固件795可以直接从前外侧连合部1085突出。前外侧连合部可以是经由前外侧连合接合处1100的前外侧锚固耳片1110(610，如图5所示)的起点和插入部。一排或多排前外侧连合附接孔1090可以位于前外侧连合部1085的结构内的前外侧连合附接槽1095附近。附接孔1090可以提供用于缝合线的位置，该缝合线可用于将前外侧连合缝合衬垫(615，如图5所示)缝合到位。前外侧连合缝合衬垫可以与前外侧连合附接孔共同作用以帮助将假体二尖瓣的瓣膜小叶固定到框架。还示出了前外侧锚固耳片1110的自由端1111、隔前锚固耳片1115的自由端1116和后锚固耳片1120的自由端1121。可以使用多个支柱或附接轨道来将小叶定位并固定到框架。每个支柱可以在连续的相邻连合部之间隔出一定空间。每个支柱可以具有“u”或弧形形式。具体地，前小叶附接轨道1080可以跨越前外侧连合部1085与隔前连合部1086之间的空间。前小叶附接轨道1080可以用于将前小叶(未示出)附接到框架。隔后小叶附接轨道1130可以跨越隔前连合部1086与后连合部1087之间的空间。隔后小叶附接轨道1130可以用于将隔后小叶(未示出)附接到框架。后外侧小叶附接轨道1125可以跨越后连合部1087与前外侧连合部1085之间的空间。后外侧小叶附接轨道1125可以用于附接后外侧小叶(未示出)。在图9的两侧上均示出了后连合锚固件805、后连合部1087、后锚固耳片1120和后锚固耳片1120的自由端1121以强调假体二尖瓣在框架平铺配置中可以如何布置。
附加结构可以支撑针对天然二尖瓣环的径向压缩和/或有助于抵靠左心房底部密封瓣膜流入。多排环状菱形1150可以位于框架的环形区域1140处，贯穿框架的圆周。多个心房裙部支撑支柱1170可以从环形区域1140发出并且可以充当针对多个心房裙部周向支柱1165的支撑梁。心房裙部支撑支柱可以基本上彼此平行并且可以纵向延伸。心房裙部周向支柱可以基本上彼此平行并且可以基本上是“v形”的。每个心房裙部支撑支柱都可以在顶部和底部连接到心房裙部周向支柱。心房裙部支撑支柱1170和心房裙部周向支柱1165的组合可以形成瓣膜框架的心房区域1160并且可以向将要缝合到瓣膜框架上的心房裙部提供位置。
图10图示了框架平铺图案1180的实施方式。框架平铺配置1180可以包括图9的任何或全部元件，具有进一步修改。框架平铺配置1180可以额外包括一个或多个支柱特征。该配置可以包括1、2、3、4、5、6、7、8、9、10个或多于10个支柱特征。例如，可以添加一个或多个支柱特征，每个支柱特征都与两个小叶附接轨道相邻。后外侧弦式缓冲支柱1190可以大致平行于后外侧小叶附接轨道1125延伸。后外侧弦式缓冲支柱1190可以通过将天然腱索推离假体瓣膜来帮助瓣膜运转。这可以进一步防止瓣膜下空间和LVOT中的阻塞。该配置可以包括一个或多个缓冲支柱附接点。该配置可以包括1、2、3、4、5、6、7、8、9、10个或多于10个缓冲支柱附接点。一个或多个后外侧弦式缓冲支柱附接点1195可以位于后外侧弦式缓冲支柱1190的每个末端处。每个后外侧弦式缓冲支柱附接点1195可以有效地将后外侧弦式缓冲支柱1190的末端连接到相邻的连合部。隔后弦式缓冲支柱1210可以大致平行于隔后小叶附接轨道1130延伸。一个或多个隔后弦式缓冲支柱附接点1200可以位于隔后弦式缓冲支柱1210的每个末端处。每个隔后弦式缓冲支柱附接点1200可以有效地将隔后弦式缓冲支柱1210的末端连接到相邻的连合部。隔后弦式缓冲支柱1210可以在功能上等同于后外侧弦式缓冲支柱1190。隔后弦式缓冲支柱附接点1200可以在功能上等同于后外侧弦式缓冲支柱附接点1195。
图11示出了框架平铺图案1220的实施方式。框架平铺配置1220可以包括图10的任何或全部元件，具有进一步修改。框架平铺配置1220还可以包括一个或多个叉骨形构件并且不存在先前所述的连合锚固件。如本文所述，这些改变可以提供将瓣膜框架锚固到递送系统的替代方法。该配置可以包括一个或多个叉骨支柱、一个或多个叉骨锚固件以及一个或多个叉骨附接点。该配置可以包括1、2、3、4、5、6、7、8、9、10个或多于10个叉骨支柱；1、2、3、4、5、6、7、8、9、10个或多于10个叉骨锚固件；以及1、2、3、4、5、6、7、8、9、10个或多于10个叉骨附接点。后外侧叉骨形支柱1230可以从前外侧连合部1085上的第一支柱附接点1240发出。后外侧叉骨形支柱1230可以弧形向上并且跨过后外侧小叶空间，直到其遇到位于后连合部1087上的第二支柱附接点1240。后外侧叉骨形支柱1230的顶点处可以是可替代先前描绘的前外侧连合锚固件和后连合锚固件(分别为图10的795和805)的后外侧叉骨锚固件1235。后外侧叉骨锚固件1235可以在功能上和结构上等同于前外侧连合锚固件和后连合锚固件。此外，隔后叉骨形支柱1250可以从隔前连合部1086上的第一支柱附接点1260发出。隔后叉骨形支柱可以弧形向上并且跨过隔后小叶空间，直到其遇到位于后连合部1087上的第二支柱附接点1260。隔后叉骨形支柱1250的顶点处可以是可以替代先前描绘的隔前连合锚固件和后连合锚固件(分别为图10的815和805)的隔后叉骨锚固件1255。隔后叉骨锚固件可以在功能上和结构上等同于隔前连合锚固件和后连合锚固件。如本文所述，叉骨形支柱可以允许迫使假体二尖瓣成为易压缩配置以供通过导管递送。这可以得到更易缩回和/或可重新定位的假体。
图12示出了框架平铺图案1270的又一实施方式。框架平铺配置1220可以包括图11的任何或全部元件，具有进一步修改。框架平铺配置1270可以缺少图11的某些元件。例如，可以从框架平铺配置1270排除后外侧弦式缓冲支柱(1190，如图11所示)和/或隔后弦式缓冲支柱(1210，如图11所示)。除了不存在所述缓冲支柱外，框架平铺配置1270可以在功能上等同于图11的框架平铺配置1220。图12的假体二尖瓣的透视图可以参见图13。
图13示出了如图12中的框架平铺配置1270所示的假体二尖瓣的透视图。图5中先前所述的任何或全部特征和元件都可以存在于图13的实施方式中。除了添加一个或多个叉骨形支柱和一个或多个叉骨附接区域外，图13的实施方式可以在功能上和结构上等同于图5的实施方式。图13的实施方式可以包括1、2、3、4、5、6、7、8、9、10个或多于10个叉骨形支柱和1、2、3、4、5、6、7、8、9、10个或多于10个叉骨附接区域1330。隔后叉骨形支柱1320可以在隔前耳片叉骨附接区域1300处找到与框架的第一插入物，其可以位于隔前连合部附近。隔后叉骨形支柱1320可以在后耳片叉骨附接区域1290处找到与框架的第二插入物，其可以位于后连合部附近。如本文所述，隔后叉骨锚固件1255可以位于叉骨的顶点处，从而允许附接到递送系统。后外侧叉骨形支柱1330可以在前外侧耳片叉骨附接区域1310处找到与框架的第一插入物，其可以位于前外侧连合部附近。后外侧叉骨形支柱1330可以在后耳片叉骨附接区域1290处找到与框架的第二插入物，其可以位于后连合部附近。如本文所述，后外侧叉骨锚固件1235可以位于叉骨的顶点处，从而允许附接到递送系统。
现有的微创手术已被开发以将假体心脏瓣膜经由穿过患者脉管系统的递送导管经皮递送到心脏，或者通过使用经心尖手术以穿过胸壁和心尖(330，如图3所示)引入假体。示例性假体包括在美国专利号8,579,964中所述的假体，所述专利的全部内容为了所有目的通过引用以其整体并入本文。以下附图描述并图示了示例性递送导管和递送系统的进一步实施方式。
图14示出了具有图13的叉骨附件的假体二尖瓣。假体二尖瓣1280可以包括图13的任何或全部元件。假体二尖瓣1280可以连接到递送系统1340。递送系统1340可以包括完全收回的递送导管1350。应当显而易见的是，前述隔后连合锚固件(1255，如图13所示)和后外侧连合锚固件(1235，如图13所示)目前被图14中的锚固套管构件1360遮蔽。递送系统1340在图14中被示为连接到非特定的锚固机构。如由放大的细节元件1345传达的，锚固机构的实施方式在图15-图19中描述。
图15A-图15B示出了用于采用多个螺纹连接器将连合锚固件锚固到递送系统的锚固方法的实施方式。图15A示出了处于连接配置中的多个螺纹连接器1370。在该连接配置中，第一阳螺纹连接器1390和第二阳螺纹连接器1395可以分别与第一阴螺纹连接器1375和第二阴螺纹连接器1380螺纹连接。第一和第二阳螺纹连接器(分别为1390和1395)可以各自包括出现在叉骨形支柱1410的自由端的一段阳螺纹1400。叉骨形支柱可以替代多个连合锚固件(1255和1235，如图13所示)。阳螺纹的尺寸可以被设定成紧固且配合阴螺纹1405的具有类似螺纹的第一段和第二段。箭头1385指示第一和第二阴螺纹连接器(分别为1375和1380)中的每一个的旋转。在沿箭头1385的方向旋转时，连接器可以处于图15B所描绘的状态。
图15B示出了处于分离配置1420中的多个螺纹连接器(1390和1395)。应当显而易见的是，在图15B所描绘的状态下，阳螺纹连接器可以从阴螺纹连接器完全分离。在分离时，最初通过叉骨连接器附接到导管递送系统的假体瓣膜可以从其递送系统完全释放。从图29的描述开始对负责操作递送系统的该实施方式的内部机构进行进一步讨论。
图16A-图16B示出了用于使用单个分裂螺纹连接器将连合锚固件锚固到递送系统的锚固方法的实施方式。图16A示出了处于连接配置中的分裂螺纹连接器1430。一个或多个阳分裂螺纹连接器1450可以与一个或多个阴分裂螺纹连接器1440螺纹连接。每个阳分裂螺纹连接器1450可以包括出现在叉骨形支柱1460的自由端处的一段阳螺纹1455。叉骨形支柱可以替代多个连合锚固件(1255和1235，如图13所示)。阳螺纹的尺寸可以被设定成紧固且配合阴螺纹连接器1440内的阴螺纹1445的类似螺纹段。箭头1435指示单个阴螺纹连接器1440的旋转。在旋转时，连接器可以处于图16B所描绘的状态。
图16B示出了处于分离配置1470中的分裂螺纹连接器1455。应当显而易见的是，在图16B所描绘的状态下，阳分裂螺纹连接器可以从阴螺纹连接器完全分离。在分离时，最初通过叉骨连接器附接到导管递送系统的假体瓣膜可以从其递送系统完全释放。从图27的描述开始对负责操作递送系统的该实施方式的内部机构进行进一步讨论。
图17A-图17B示出了用于使用挠曲销连接器型锚固机构将连合锚固件锚固到递送系统的锚固方法的实施方式。图17A示出了处于连接配置中的挠曲销连接器型锚固机构1480。一个或多个挠性套管1490可以围绕多个针孔连接器1530关闭。挠性套管1490可以包括多个挠性套管部分1495，当平移套管1500被拉过或拉出挠性套管部分1495时，挠性套管部分1495可能能够突然打开和闭合。平移套管的这种移动可以有效地封装挠性套管部分1495。如本领域技术人员已知的，挠性套管1490可以包括可定形和/或超弹性的镍钛诺材料。每个挠性套管部分1495可以包括出现在挠性套管1490的自由端处的终点1510。该终点可以允许挠曲销连接器型锚固机构1480连接到叉骨形支柱1520。
图17B示出了处于分离配置1540中的挠曲销连接器型锚固机构1480。终点1510中的每一个的内表面可以包括能够配合到用于销连接的互补孔1560中的连接器销1555。假体二尖瓣的叉骨形支柱1520中的每个可以在针孔连接器1530中终止。针孔连接器可以替代多个连合锚固件(1255和1235，如图13所示)。箭头1550指示单独的挠性套管部分1495中的每一个的旋转。在旋转时，连接器可以处于图17B所描绘的状态。箭头1545指示平移套管1500在挠性套管部分1495上方的平移。应当显而易见的是，在图17B所描绘的状态下，连接器销1555可以从用于销连接的孔1560完全分离。在分离时，最初通过叉骨连接器附接到导管递送系统的假体瓣膜可以从其递送系统完全释放。从图24A的描述开始对负责操作递送系统的该实施方式的内部机构进行进一步讨论。
图18A-图18C示出了用于采用多个挠性卡扣型锚固机构将连合锚固件锚固到递送系统的锚固方法的实施方式。图18A示出了处于连接配置中的多个挠性卡扣型连接器1570。多个挠性卡扣1580可以与孔1575捕获连接、被孔1575限制或安置在孔1575内，该孔1575的尺寸被设定成接受挠性卡扣1580并使用相反的张力来保持挠性卡扣1580。可以将孔塑造在平移套管1500的侧面。每个挠性卡扣可以位于叉骨形支柱1520的末端附近并从该末端突出，叉骨形支柱1520可以替代多个连合锚固件(1255和1235，如图13所示)。鞘套导管1350可以同心地定位在平移套管1500的顶部上方。当相对于鞘套导管1350拉动平移套管1500时，可以实现作用机制。
图18B描绘了挠性卡扣1580的被遮蔽的结构，由于在图18A的视图中，平移套管1500遮挡了所述结构。
图18C示出了处于分离配置中的挠性卡扣型锚固机构。当相对于鞘套导管1350拉动平移套管1500时，挠性卡扣1585可以被鞘套导管1350的内表面压迫闭合并解除约束。应当显而易见的是，在图18C所描绘的状态下，挠性卡扣型连接器可以从其孔1575和相关联的平移套管1500完全分离。在分离时，最初通过叉骨连接附接到导管递送系统的假体瓣膜可以从其递送系统完全释放。从图26A的描述开始对负责操作递送系统的该实施方式的内部机构进行进一步讨论。
图19A-图19B示出了用于使用多个锚形连合锚固件将连合锚固件锚固到递送系统的锚固方法的实施方式。图19A示出了处于连接配置中的多个锚形连合锚固件1630，其与多个叉骨形支柱1410的末端相邻并连接。多个连合锚固件1630可以停留在互补的多个槽1615内。槽可以用于保持锚固件并抵抗在递送系统的操作期间可能形成的张力。可以将槽1615塑造在锚固导管1600的锚固端1610上。图19A-图19B中所示的多个连合锚固件1630可以在设计、构造和功能上与多个连合锚固件(1255和1235，如图13所示)相同。
图19B示出了处于未约束配置中的可以允许分离的连合锚固件1640。箭头1620指示锚固套管构件1360的平移。在平移时可以实现图19B中所描绘的状态。应当显而易见的是，在图19B所描绘的状态下，连合锚固件1640可以是未约束的并且能够从锚固导管1600的槽1615分离。在分离时，最初附接到导管递送系统的假体瓣膜可以从其递送系统释放。从图21A的描述开始对负责操作递送系统的该实施方式的内部机构进行进一步讨论。
图20A-20F示出了使递送系统的实施方式出鞘和植入二尖瓣假体的连续阶段。虽然参考为了说明所必需的相关元件讨论了所述递送系统的操作(诸如约束的假体二尖瓣的释放)的所得效果，但递送系统实施方式的物理实现所需的各种内部组件的机械关系直到更下面的图21-图31中才被图示或讨论。如图20A-图20F中描绘的展开过程如下进行。当在植入区内到位时，可以约束由组织、织物、缝合线和镍钛诺框架组成的压缩假体瓣膜的鞘套导管可以从瓣膜缩回。患者心脏中的血液的生理温度可以导致镍钛诺材料扩张并且符合其所植入的空间。当假体扩张时，负责锚固到天然解剖结构的本发明的元件也可以扩张，从而允许假体保持到位以便作为单向瓣膜起作用并且支持血液的正确循环。应当认识到，相关的解剖结构先前已在图1-图4中说明，而不在后续附图中重复，以便留出空间专注于假体和递送系统。
图20A描绘了完全装载的(入鞘且闭合的)递送系统1700的实施方式。递送系统可以包括在植入之前已被压缩并插入鞘套导管1350中的假体二尖瓣(在图20B-图20F中示出)。长的、锥形且挠性的自膨胀膨胀器端头1710可以有助于将递送系统插入在预期患者(未示出)中准备的小切口内。切口可以在胸部形成，并且可以直接进入并通过心尖。膨胀器端头1710的最宽末端可以由边缘1720终止，该边缘1720可以相对于可以出现在鞘套导管1350的远端上的前缘1725对齐并同心地配合在该前缘1725内。管腔1715可以在膨胀器端头1710的最远侧部分处形成，并且可以延伸贯穿膨胀器端头1710所附接的整个导管。
图20B描绘了显露出心房裙部的装载的递送系统的实施方式1730，示出了先前在图20A中描述的鞘套导管1350远离膨胀器端头1710平移了一小段距离。具体地，鞘套导管1350的前缘1725可以远离膨胀器端头1710的边缘1720移动，并且可以由此显露部分受约束的心房裙部1750。
图20C描绘了显露出前三角形锚固耳片的装载的递送系统的实施方式1760，示出了先前在图20B中描述的鞘套导管1350远离膨胀器端头1710平移了更大的程度。具体地，鞘套导管1350的前缘1725可以进一步远离膨胀器端头1710的边缘1720移动，并且可以由此显露所封装的假体二尖瓣的大部分结构。现在心房裙部1770可以大致被释放，但部分仍受约束的环形区域1775可以被鞘套导管1350约束。图20C的配置可以移除一定的约束，这可以允许假体二尖瓣的一部分的自扩张。邻近受约束的环形区域1775且直接位于其下方的可以是受约束的前小叶1780，前小叶1780可以基本上保持被压缩。从鞘套导管1350的前缘1725下方突出的可以是多个三角形锚固耳片，诸如前外侧三角形锚固耳片790(具有相关联的自由端1790)以及隔前三角形锚固耳片540(具有相关联的自由端545)。
图20D描绘了前三角形锚固耳片完全打开的装载的递送系统的实施方式1800，示出了先前在图20C中描述的鞘套导管1350远离膨胀器端头1710平移了更大的程度。具体地，鞘套导管1350的前缘1725可以进一步远离膨胀器端头1710的边缘1720移动，并且可以由此显露出除了连合附接处(未示出)之外的封装假体二尖瓣的全部结构。现在心房裙部1770可以完全不受约束，环形区域1810同样也可以完全不受约束。邻近环形区域1810且直接位于其下方的可以是可以几乎完全释放的部分受约束的前小叶1825。前小叶1825可以是可操作的且能够接合该实施方式中存在的任何其他小叶(未示出)。由于鞘套导管1350的前缘1725与三角形锚固耳片可以直接连接到的仍受约束的叉骨形支柱1820之间的相互作用，多个三角形锚固耳片(前外侧三角形锚固耳片790和相关联的自由端1790以及隔前三角形锚固耳片540和相关联的自由端545)可以张开。这种打开效果可以允许三角形锚固耳片抵达天然前二尖瓣小叶(460，如图4所示)周围并且通过前腱索(465，如图4所示)以便在释放后邻接三角区。从鞘套导管1350发出并同心嵌套在鞘套导管1350内的可以是导丝导管1830，该导丝导管1830可以直接连接到膨胀器端头1710并为其提供支撑。
图20E示出了即将最终释放之前的装载的递送系统的实施方式1840，示出了先前在图20D中描述的鞘套导管1350远离膨胀器端头1710平移了更大的程度。具体地，鞘套导管1350的前缘1725可以进一步远离膨胀器端头1710的边缘1720移动，并且可以由此显露出所封装的假体二尖瓣的全部结构，诸如可能即将从递送系统释放的完全展开的叉骨形支柱1880。隔前三角形锚固耳片1860和前外侧三角形锚固耳片1870可以从它们的约束释放，并且现在可以处于它们的最终位置。前小叶1850可以是完全自由的且可以处于横跨天然前小叶的可操作状态。
图20F描绘了移除递送系统的最终展开1890。叉骨形支柱1900和相关联的连合锚固件1910可以被全部释放且不受递送系统的约束。在本描绘中，本发明的假体可以是功能完全的且可以在天然解剖结构内自由操作。
现将参考图21-图31中出现的元件呈现对几个相关递送系统实施方式的全面讨论。
图21A-图23描绘了对应于与图19A-图19B相关的描述并且可以与图13中描述的假体二尖瓣实施方式相容的递送系统的实施方式。
图21A示出了完全打开的长度延伸的递送系统1920的实施方式。递送系统可以包括递送系统手柄1940。递送系统手柄可以包括细长的可抓握构件1960，该抓握构件1960可以允许容纳各种机械组件，并且可以向一系列同心嵌套导管提供位置。递送系统手柄1940还可以提供致动机构，诸如呈可旋转(参见指示旋转的箭头1950)指轮1955形式的致动机构。指轮可以基本上是圆柱形的且可以具有将使用者施加的旋转扭矩转换成线性力的内螺纹(未示出)。该线性力可以用于使某些导管从该系列同心嵌套导管平移。先前讨论的鞘套导管1350再次被呈现，并且可以是具有内管腔的、从递送系统手柄1940内延伸到前缘1725的基本上圆柱形的管，该管可以经过定位在整个装置最远端的膨胀器端头1710的边缘1720与远离边缘1720朝向近侧的设定距离之间的距离，该设定距离可以基本上等于假体瓣膜(未示出)的约束长度。锚固套管构件1360可以同心嵌套在其自身也可以具有内管腔的鞘套导管1350内，该内管腔从递送系统手柄1940内延伸直至并略微超出锚固导管1930的端头。锚固导管1930自身可以是圆柱形的，并且可以同心嵌套在锚固套管构件1360内。图22中提供了关于锚固导管1930的进一步细节。最内部的同心嵌套的导管是导丝导管1830，其可以连接到膨胀器端头1710。可以存在延伸穿过递送系统整个长度的内管腔，该内管腔的尺寸可以被适当地设定成接纳并传递可以放置在其中的导丝(未示出)。描绘平移的箭头1925示出了当指轮1955旋转时，鞘套导管1350可以如何被带成朝向膨胀器端头1710。
图21B示出了在配置示1970中在图21A中介绍的装置，区别仅在于鞘套导管1350的位置和锚固套管构件1360的位置。鞘套导管可以更进一步朝向膨胀器端头1710平移(如指示平移的箭头1975所示)。锚固套管构件1360也可以平移。通过朝向膨胀器端头1710平移，锚固套管构件1360可以有效地覆盖锚固导管1930(图21A)。这与图19A和图19B所描绘的机械关系相同，但顺序相反。
图21C示出了闭合的递送系统1980，其中指轮1955可以旋转至其完全程度，并且鞘套导管1350可以被使得紧靠膨胀器端头1710。
图22示出了如图21A所示的装置的实施方式和配置，其中附加细节呈放大视图1985的形式。具体地，稳定器构件1990可以位于鞘套导管1350的内表面与锚固套管构件1360的外表面之间。稳定器构件可以采用星形圆柱形棱柱的形式。稳定器构件可以迫使所述导管之间具有同心性，同时仍允许血液和/或盐水流过。还描画了锚固导管1930的开槽端。可以看出，锚固套管构件1360可以同心地围绕锚固导管1930定位并且定位成与锚固导管1930可滑动连通。再次示出了离开锚固导管1930的导丝导管1830。
图23图示了图21A-图22B的示例性装置的分解视图。该装置可以包括可以与递送系统手柄B侧2145配合连接的递送系统手柄A侧2140。该装置可以有效地向在手柄元件左侧看到的系列同心嵌套导管(并在图22中描述)和在手柄元件的右侧看到的各种元件提供壳体和位置。该装置可以包括针座2130，该针座2130可以与导丝导管1830的近端2000配合连接。可以使用粘合剂形成配合连接。针座2130可以充当连接端口，注射器(未示出)可以通过该连接端口附接到装置并且用于在插入患者之前使无菌盐水冲洗通过最内部的管腔以去除空气。圆柱形锚固螺母2120可以与锚固导管2010的近端2035上的螺纹处于螺纹连接。圆柱形锚固螺母可以位于多个手柄半部2140和2145内，以便将锚固导管2010紧固到递送系统。内管腔可以在锚固导管2010的整个长度上延伸并且可以允许导丝导管1830同心嵌套在其内。弹簧2110可以配合并压靠钟形滑动器帽2100，该钟形滑动器帽自身可以配合到钟形滑动器2090。弹簧2110可以提供偏置力，当导螺杆2080脱离与钟形滑动器2090的接触时，钟形滑动器2090可以通过该偏置力移动。换句话说，通过旋转指轮1955，导螺杆2080可以线性平移并且可以被使得与钟形滑动器2090的远侧部分接触，所述远侧部分进而可以抵靠弹簧2110偏置。钟形滑动器2090可以充当钟形导管2040的近端2060(先前称为锚固套管构件1360)的滑座并且可以允许所述钟形导管2040的远端2050被带离锚固导管2010的远端2020，该锚固导管2010可以是负责最终瓣膜连合部释放的机构。导螺杆2080还可以通过转动指轮1955在相反的方向上平移，以便闭合递送系统并将瓣膜密封在内。这可以通过导螺杆2080与导螺杆帽2070的连接来实现，该导螺杆帽2070自身可以配合到鞘套导管1350的近端2065。因此，在第一方向上旋转指轮1955可以使导螺杆2080朝向膨胀器端头1710移动，并且通过延伸还可以使鞘套导管1350朝向所述膨胀器端头1710移动，以便闭合装置。在相反的第二方向上旋转指轮1955可以使导螺杆2080朝向钟形滑动器2090移动，并且通过延伸可以使鞘套导管1350和钟形导管2040两者远离膨胀器端头1710移动，以打开装置并释放其中包含的假体瓣膜。应当理解，虽然鞘套导管1350和钟形导管2040两者可以通过指轮1955旋转而同步移动，但在由相关导管和导螺杆2080的尺寸提供的接触中可能存在延迟。当展开进行时，延迟可以允许假体的一些部分先于其他部分被揭开。还应当理解，通过简单地闭合鞘套导管1350直到所述鞘套导管1350的前缘1725再次接触膨胀器端头1710的边缘1720，可以最终重新捕获或获得假体瓣膜以供重新定位或移除。最后，导丝导管1830的远端1995可以与膨胀器端头1710配合连接并且锚固到膨胀器端头1710。
图24A-图25描绘了对应于与图17A-图17B相关的描述的递送系统的实施方式。以与图24A-图24C中所示的图示相同的方式，指轮1955旋转与鞘套导管1350平移之间的关系也在此示出。在图24A中，完全打开的递送系统2150可以被设计用于与假体瓣膜(未示出)的挠性连接类型的附接。指示旋转的箭头2190显示，当指轮1955旋转时，鞘套导管1350可以再次朝向膨胀器端头1710平移(参见指示平移的箭头2180)。在本实施方式中，由于挠性连接器叉状物2160固有的弓形轮廓和所述挠性连接器叉状物2160与鞘套导管1350的前缘1725之间逐渐增加的接触水平，多个挠性连接器叉状物2160可以经受凸轮作用。这可以使挠性连接器叉状物2160彼此紧密接触。在每个挠性连接器叉状物2160的远侧端头处可以是连接元件2170，该连接元件可以是基本上圆柱形的凸台，该凸台可以与相关联的假体瓣膜的连合元件(图17B中示出的元件1530、1555和1560)内的基本上圆柱形的孔或腔配合。图24B和图24C示出了入鞘过程的逻辑延续(图24B中2200部分打开，图24C中2210完全闭合)，由此鞘套导管1350的前缘1725可以最终被使得与膨胀器端头1710的边缘1720接触。
图25示出了图24A-图24C中介绍的递送系统的分解视图。在本描述中阐述的组件可以仅与图23中阐述的组件稍有不同。由于可以通过鞘套导管1350的前缘1725与多个挠性连接器叉状物2160之间的关系来提供捕获机构，因此如图25所示的递送系统的实施方式可以不需要钟形导管。因此，图25的实施方式也可以不需要钟形滑动器。为了操作该装置，使用者可以仅需要用指轮1955来回拉动鞘套导管1350，从而直接压缩多个挠性连接器叉状物2160。应当容易理解，挠性连接器叉状物2160可以被塑造成挠性叉状锚固导管2220的远端。
图26A-图26B描绘了对应于与图18A-图18C相关的描述的递送系统的实施方式。图26A示出了可以适用于与具有挠性卡扣型锚固件的假体瓣膜框架连接的递送系统的实施方式的分解视图。在本描述中阐述的组件可以仅与图23中阐述的组件稍有不同。在图26A-图26B的实施方式中，锚固导管2010的近端2035可以与钟形滑动器2090(而不是锚固螺母)配合连接，并且在与导螺杆2080接触时可能能够随着钟形滑动器2090自由平移。钟形滑动器2090还可以包括多个销2226，销2226可以将力从导螺杆2080传递到钟形滑动器2090，同时还为可以将静止钟形导管2040锚固并保持到递送系统的静止钟形导管螺母2224提供间隙。因此，通过旋转指轮1955，导螺杆2080可以被使得与多个销2226接触，从而迫使钟形滑动器2090和锚固导管2010向近侧远离膨胀器端头1710。这可以有效地将锚固导管2010缩回到静止钟形导管2040中。这种关系在图26B中更详细地图示。
在图26B中提供了放大视图2228，其详细示出了可以存在于平移锚固导管2010和静止钟形导管2040最远端处的元件。当锚固导管2010的远端2227被带入钟形导管2040的远端2050时，可能在锚固导管2010的远端2227内形成的孔2229也可以被带入所述钟形导管远端2050。该动作可以有效地提供图18A-图18C图示的实施方式背后的机制。
图27和图28描绘了对应于与图16A-图16B相关的描述的递送系统的实施方式。图27示出了可以适用于与具有单螺纹连接器锚固件的假体瓣膜框架连接的递送系统的实施方式的分解视图2230。在本描述中阐述的组件可以仅与图23中阐述的组件稍有不同。该实施方式可以包括多个稳定器1990。该稳定器可以改善同心嵌套导管的同心性。此外，多个手柄半部(A侧2250和B侧2260)可以向各个内部组件提供位置。递送系统还可以包括多个指轮，诸如用于致动鞘套导管1350的第一指轮1955和用于旋转螺纹钟形导管2040的第二指轮2270。第一指轮和第二指轮可以允许导管与相关假体瓣膜连接和分离。此外，第二指轮2270可以包含孔2275，旋转钟形导管2040的近端2060可以通过孔2275被紧固到所述第二指轮2270。提供了系列同心嵌套导管的分解视图2240，并且图28中提供了关于系列导管的远端处的螺纹机构的进一步细节。
图28示出了聚焦于系列嵌套导管的远端的分解视图2280。箭头2300指示旋转，其对应于钟形导管2310的螺纹远端的旋转，以便与可能存在于瓣膜假体中的螺纹紧固件连接或分离。
图29A-图31描绘了对应于与图15A-图15B相关的描述的递送系统的实施方式。图29示出了可以适用于与具有多个螺纹型连接器锚固件(1400，如图15A所示)的假体瓣膜框架连接的递送系统的实施方式的分解视图。在本描述中阐述的组件可以基本上类似于图23中阐述的组件。图29示出了递送系统2320的递送手柄部分的分解视图和同心嵌套导管2330的分解视图。可以在递送系统手柄A侧2370和B侧2380二者的近端处形成槽2390。该槽可以允许杠杆2420的旋转位移，杠杆2420可以与圆柱形扭矩传递构件2410正交并且起源于圆柱形扭矩传递构件2410。扭矩传递构件2410可以与扭矩导管2350的近端或主动端2355配合连接，并且可以在终止于远端或从动端2352之前同心地行进穿过导管固定件2400、导螺杆2080、多个稳定器2360和鞘套导管1350，该远端或从动端2352可以通过齿轮关系进一步传递扭矩并在图31中进一步描述。导管固定件2400可以为多个扭转螺纹连接器导管2340的固定端2345提供横向位置和固定。螺纹连接器导管2340可以是长而薄的挠性构件，其在受压时可以在结构上是刚性的。当施加适当的扭矩时，螺纹连接器导管可以能够绕其轴扭转。为了维持扭矩导管2350与多个螺纹连接器导管2340之间的邻接，多个稳定器2360可以充当轴颈轴承以从内部保持扭矩导管2350的放置并且从外部保持多个螺纹连接器导管2340的放置。多个螺纹连接器导管可以同心嵌套在鞘套导管1350内。如前所述，通过旋转指轮1955，可以使导螺杆2080平移，并且通过延伸可以使鞘套导管1350平移，这进而可以使鞘套导管1350的前缘1725朝向膨胀器端头1710前进或从膨胀器端头1710退回。
图30更详细地示出了图29的分解视图2330，并示出了系列导管的嵌套配置。
图31示出了放大视图2430，其详细图示了图29的递送系统远端处的机械相互作用。如前所述，对可以可操作地耦合到扭矩导管(2350，如图29所示)的从动端2352的杠杆(2420，如图29所示)进行致动可以导致扭矩导管旋转，并且还可以导致主动齿轮2490旋转并将扭矩传递到多个从动齿轮2470，多个从动齿轮2470与多个螺纹连接器导管2340的远端2342相邻并且通过延伸还与每个螺纹连接器导管2340的螺纹插口2480相邻。应当显而易见的是，主动齿轮2490在第一方向上的旋转(如指示旋转的箭头2460所示)可以导致每个从动齿轮2470在与第一方向相反的第二方向上的旋转(如指示旋转的箭头2450所示)。主动齿轮2490与从动齿轮2470之间可以存在机械效益。机械效益可以导致从动齿轮相对于主动齿轮的旋转位移增加。机械效益可以提供从动齿轮相对于主动齿轮的旋转位移的4：1的增加。每个螺纹连接器导管2340的远端2342处可以是可以用于连接配合到螺纹紧固件(1390和1395，如图15A所示)的螺纹插口(2480，如图31所示)，该螺纹紧固件可以锚固到假体瓣膜的实施方式。
图32图示了植入患者心脏的二尖瓣中的假体瓣膜。采用传统植入方法和传统装置，可能破坏天然血流路径并且血流可能变得紊乱。血液可以朝向心尖并朝向隔膜壁流动，从而产生湍流。
图33图示了穿过二尖瓣并离开心室的期望的血流路径。天然二尖瓣引导血液沿着心室的后壁朝向心尖流动，其中血液继续以非湍流方式沿隔膜壁向上流动，然后在心脏收缩期期间血液被排出左心室流出道(LVOT)并通过主动脉流到身体的其余部分。在这种配置下，血流维持其动量并节约其能量，从而实现最有效的流动。
图34图示了植入天然二尖瓣中的假体瓣膜。假体二尖瓣具有这样的特征，其优选地避免阻塞左心室流出道并且还可以帮助维持天然血流路径以便保持血流的动量并避免湍流。例如，假体瓣膜优选地具有跨越天然前瓣膜小叶宽度的大的前假体瓣膜小叶3410。这会有助于模拟天然瓣膜小叶的大小和运动，从而避免LVOT阻塞。此外，假体具有小轮廓，因此它不会延伸太远而进入心室，并且心房凸缘或裙部有助于将假体锚固在心房底部。心房裙部3420也优选地具有小轮廓。假体还可以包括一个或优选两个前锚固耳片3430，前锚固耳片3430在天然瓣膜小叶的背后(天然小叶的前侧)延伸并将假体锚固在瓣膜的前部上的纤维三角区，或者锚固在与前小叶相邻且在前小叶的前侧的组织上。瓣膜的主体3440可以将血流引导至后侧。锚固耳片的附加细节可在美国专利号8,579,964中找到，所述专利的全部内容先前已经通过引用并入本文。假体的主体可以被设计成避免LVOT阻塞，并且这可以帮助引导血流以循环的方式沿着心脏的后壁朝向心尖向下，然后沿着隔膜朝向LVOT向上，从而维持避免湍流并维持血流动量的基本上正常的血流路径。在本说明书中更详细地讨论了关于假体的这些特征和其他特征的附加细节。
图35图示了优选具有大的前假体小叶和两个后小叶的假体的心室视图。优选地，使用三个连合杆来支撑假体瓣膜小叶并形成三尖瓣假体瓣膜。假体可以包括心房裙部3520。此外，假体优选地包括两个前锚固耳片3510和可选的一个或多个后锚固耳片3530。前锚固耳片可以锚固到瓣膜的纤维三角区，或者它们可以锚固到前小叶前侧的组织并与其相邻，并且为了避免干扰前假体小叶的移动，前锚固耳片还优选地位于与连合杆相同的周向位置处。在本示例性实施方式中，前锚固耳片大致位于沿着连合杆中的两个的10点钟和2点钟位置。假体优选地是D形的，以便符合天然瓣膜解剖结构。因此，瓣膜的前部优选地是平坦且线型的，使得它不会冲击LVOT，并且假体的后侧优选地是圆柱形的，使得它符合天然瓣膜。在一些实施方式中，除了平坦且线型的前部之外，前部还可以是凹入的或略微凸出的。
图36A更清楚地图示了朝向心房向上并远离朝向心室延伸的连合杆延伸的两个前锚固耳片，并且类似地，后锚固件也朝向心房向上延伸，而相邻的连合杆朝向心室向下延伸。注意在该视图中，只有一个前锚固耳片可见。假体可以包括心房裙部3610。
图36B图示了图36A的假体的流出视图，由此呈现了两个前三角形锚固耳片以及后锚固耳片，以及与所述耳片中的每一个相关联的连合部。应当显而易见的是，连合杆和锚固耳片彼此相邻。假体可以包括前锚固件3620、前小叶3630、前连合部3640、后锚固件3650和后连合部3660。
图37图示了用于将假体耦合至递送导管的假体上的结构的两个实施方式。该图示出了锚固框架在被平铺和铺开后的图案。该锚固框架由许多相互连接的支柱形成，该支柱形成可以自扩张或可以进行球囊扩张的开放或闭合的单元。在图37的左侧，第一示例性实施方式示出了在装置的心房部分上形成闭合的单个单元的单个弓形支柱。该支柱可以径向向外折叠，以形成可以锚固到心房底部的凸缘区域或心房裙部。如本说明书中先前所述和先前通过引用并入的美国专利号8,579,964中所述，在假体的相对端上具有D形或蘑菇头形或锚形部分的连合杆可以用于使装置与递送导管耦合和解耦，并且通常在装置的心室部分上。三角形锚固耳片嵌套在连合杆与心房凸缘之间的单个单元中。因此，锚固耳片优于连合杆。锚固耳片可以形成为在展开期间径向向外张开，使得锚固耳片可以被安置在天然小叶背后(前天然小叶的前侧或天然后小叶的后侧)并且如本说明书中所述，接合前侧或后侧天然解剖结构。连合部可以具有安置在其中的缝合孔，以便允许缝合线将组织或其他材料附接到连合杆。将锚固耳片嵌套在连合杆附近有助于减小整体装置轮廓。
图37的右手侧图示了允许将假体耦合至递送导管的锚固件结构的另一示例性实施方式。在右手侧，多个闭合的单元形成装置的心房区域，该区域可以形成为径向向外张开并且产生可以紧固到心房的心房底部的凸缘区域。两个连合杆包括用于接纳缝合线的开槽区域，使得组织或其他材料可以耦合至该装置。连合杆与具有可以耦合至递送导管的中心耳片的叉骨形支柱连接在一起。叉骨可以在两个连合部或三个连合部或更多个连合部之间延伸。因此，在该实施方式中，仅使用单个连接器将假体耦合至递送导管。可以通过对平板进行制管(例如海波管)、激光切割或光刻蚀以及将末端焊接在一起或者通过本领域已知的其他技术来EDM机械加工或激光切割框架的支柱。
图38图示了假体二尖瓣的透视图。上部包括心房裙部或心房凸缘，该心房裙部或心房凸缘通常采取与先前通过引用并入本文的美国专利号8,579,964中所述的心房裙部或心房凸缘相同的形式。还示出了假体瓣膜小叶，并且其优选地包括跨越天然前二尖瓣小叶的宽度的一个大的前小叶，并且可以包括两个或三个或更多个后假体小叶。因此，假体瓣膜可以仅具有两个假体小叶，或总共具有三个或更多个假体小叶。两个前锚固耳片还优选地共享与连合杆相同的位置。这使前连合杆和前锚固耳片保持在流动路径之外，从而有助于避免LVOT阻塞，并且还有助于在收缩配置中将装置的整体轮廓保持在最小，这在递送期间是所期望的。
图39A示出了处于扩张配置中的假体瓣膜的前视图，其中锚固耳片向外张开并且处于扩张配置中。
图39B示出了具有四个假体小叶的假体瓣膜的俯视图，所述四个假体小叶包括跨越天然前小叶的宽度的一个大的前小叶和三个后小叶，其全部与可以任选地与四个锚固耳片组合的四个连合杆耦合在一起。这些锚固耳片中的两个优选地是用于将假体瓣膜锚固到纤维三角区或本文所述的任何其他解剖学位置(包括前小叶前侧的区域和与其相邻的区域)的前锚固耳片，并且两个后锚固耳片可以将假体瓣膜锚固到后环的后架和天然后小叶的后侧。
图40示出了假体通过经隔膜或经心尖递送系统进行的展开。在任一个所述递送系统中，优选地，外部鞘套导管约束装置使其无法自扩张，并且当外部鞘套导管被缩回时装置自扩张。这里，鞘套导管被部分缩回，并且前锚固耳片4010和后锚固耳片4020被部分展开。
图41示出了具有用于心房锚固的上鞍形心房裙部以及组合的大的前小叶和两个或三个后小叶以及组合的锚固耳片/连合杆的假体瓣膜的局部透视图。
图42示出了嵌套在连合杆中的组合的前锚固耳片或后锚固耳片的平铺图案。在替代实施方式中，锚固件可以在连合杆上方切割并且在热处理和定型期间向后弯曲，如此它们可以如本说明书中所述锚固到天然心脏瓣膜解剖结构。这可能需要在展开假体的其他部分之前，首先展开锚固件，如图40所示。这还可以涉及在假体的流入端和流出端同时将假体锚固到递送导管以供成功递送。
图43A示出了未扩张的锚固耳片，其在收缩配置中可以呈三角形，而在扩张配置中具有水平桨形以便增加接触面积，并由此最小化锚固期间的组织创伤、组织刺穿，如图43B所示。可替代地，锚固件可以具有刺穿或嵌入组织中以帮助锚固装置的尖端头。
图43C示出了假体的示例性切割图案，其提供了图43A-图43B中所示的结果。
图44图示了假体瓣膜的俯视图，其具有跨越天然前小叶宽度的大的前小叶和两个后假体小叶。假体小叶与三个连合杆耦合在一起。
图45示出了假体的各部分，包括上心房裙部、环形区域和可以与连合杆结合的锚固耳片。锚固耳片优选为10mm-50mm长，更优选为20mm-30mm长，以允许足够的长度进入天然瓣膜小叶的下方和背后，从而抵达纤维三角区和/或后环或者锚固在本文所述的其他解剖学位置(包括在天然小叶前侧的区域和与其相邻的区域)上。可选地，假体瓣膜可以不包括后锚固耳片。优选为D形的环形部分可以径向扩张成与天然瓣膜环接合，因此径向力可以足以防止假体的后部倾斜或以其他方式向上枢转进入心房。或者可以使用齿状件来接合和/或穿透后环。
在任何实施方式中，如果需要的话，可以重新捕获假体并使假体重新入鞘，以便中止递送手术或重新定位装置。
优选的实施方式由镍钛诺或任何其他自扩张的生物相容性材料形成。优选的目标尺寸和轮廓可以取决于患者的解剖结构，但据估计是可以在尺寸小于45French的递送系统中递送的约30mm-50mm×40mm-50mm的D形假体。更优选地，假体为35mm-45mm x 40mm-50mm的D形，并且通过尺寸小于40French的递送系统递送。优选较小的尺寸，并且名义上，假体是40mm x 45mm的D形并且通过小于40French的递送系统递送。
在一些实施方式中，系绳可以用于帮助将假体耦合至递送系统以控制递送。
图46示出了具有四个假体小叶和四个连合杆的假体瓣膜的俯视图。可选地，四个锚固耳片也可以与四个连合杆共同定位。
图47示出了具有三个假体小叶和三个连合杆的假体瓣膜的俯视图。可选地，三个锚固耳片也可以与三个连合杆共同定位。
图48示出了被展开和平铺且具有三个连合杆与三个假体小叶和三个锚固耳片的假体。在连合杆和锚固耳片下方还图示了心房裙部。
图49示出了在三个锚固耳片上方展开、平铺和叠加的天然前小叶和后小叶。
图50示出了锚固耳片(三角形单元)连接到如图40所示的被配置用于展开的连合杆的实施方式，其中当递送系统被缩回时，锚固耳片首先作为外鞘套展开。描绘了该实施方式的替代导管附接方法。蘑菇形锚固耳片在装置的心房方面的使用或中心叉骨型附接的使用均可以用来将装置紧固到导管。
图51示出了叠加在两个前锚固耳片上的大的前小叶和钻石形单元的后部分，该后部分在不使用后锚固耳片的示例性实施方式中可以接合或刺穿后环。
图52图示了另一示例性实施方式，其示出了在前连合杆内形成并嵌套的两个前锚固耳片以及一系列可扩张的钻石形单元，该钻石形单元可以抵靠后环锚固或可以刺入后环，从而避免对后锚固耳片的需要。该实施方式包括四个连合杆。
图53图示了具有嵌套在两个前连合杆中的两个前锚固耳片和两个后连合杆的假体瓣膜的另一示例性平铺图案。心房凸缘在连合杆下方示出。
图54示出了具有四个连合杆和耦合至两个前连合杆的大的前假体小叶的假体瓣膜的透视图。
图55示出了与主动脉瓣相邻的天然二尖瓣，并且优选地，前小叶在收缩期期间远离LVOT适当移动。优选地，假体前小叶将会具有类似的运动以维持天然流动力学，诸如维持血流动量并减少或消除湍流。
图56示出了具有嵌套在连合杆内的锚固耳片的假体瓣膜的一部分的另一示例性实施方式，并且还示出了框架的相邻闭合单元。
图57图示了具有连合杆和与连合杆嵌套的锚固耳片的假体瓣膜的又一示例性实施方式。
图58示出了具有嵌套在连合杆内的锚固耳片的假体瓣膜的又一示例性变体。
图59示出了可变的支柱厚度(例如，较厚区域5910和较薄区域5920)可以如何用于控制假体的材料特性以产生较硬区域和较不硬的区域。
虽然本文已经示出和描述了本发明的优选实施方式，但是对于本领域技术人员而言将会显而易见的是，这些实施方式仅以示例的方式提供。本领域技术人员现在将会想到众多变化、改变和替换，而不会脱离本发明。应当理解，在本发明的实践中可以采用针对本文所述的本发明实施方式的各种替代方案。目的是，以下权利要求限定本发明的范围，并因此涵盖这些权利要求范围内的方法和结构及其等同物。

Claims (9)

1.一种用于植入患者的天然二尖瓣中的假体心脏瓣膜，所述假体心脏瓣膜包括：
具有扩张配置和收缩配置的径向可扩张锚固框架，
其中所述锚固框架还包括前锚固耳片以及多个连合杆，所述多个连合杆具有自由端和耦合至所述锚固框架的相对端，
其中所述前锚固耳片被配置用于锚固在所述天然二尖瓣的前部上，
其中所述前锚固耳片起源于所述多个连合杆，或者其中所述多个连合杆起源于所述前锚固耳片，
其中所述锚固框架还包括起源于所述多个连合杆的多个叉骨形支柱，并且所述多个叉骨形支柱被配置用于弓形地跨越所述多个连合杆中的相邻连合杆之间的距离，并且
其中每个叉骨形支柱包括与所述叉骨形支柱的自由端相邻的锚固元件，所述锚固元件被配置用于接合递送导管；以及
耦合至所述锚固框架的假体瓣膜，所述假体瓣膜包括各自具有自由端和固定端的多个假体瓣膜小叶，其中所述固定端耦合至所述锚固框架，并且其中所述多个假体瓣膜小叶的所述自由端具有打开配置和闭合配置，在所述打开配置中所述多个假体瓣膜小叶的所述自由端被安置成彼此远离以允许顺行血流在其中穿过，而在所述闭合配置中所述多个假体瓣膜小叶的所述自由端被安置成彼此相邻以基本上防止逆行血流在其中穿过，
其中所述多个连合杆耦合至所述多个假体瓣膜小叶，并且
其中所述多个假体瓣膜小叶包括尺寸被设定成跨越天然前小叶的整个宽度的前假体小叶，并且
其中在收缩期，所述前假体小叶远离左心室流出道偏斜以提供畅通的无阻塞流出路径。
2.根据权利要求1所述的假体心脏瓣膜，其中所述天然二尖瓣的所述前部包括纤维三角区。
3.根据权利要求1所述的假体心脏瓣膜，其中所述锚固框架包括被配置用于锚固在所述天然二尖瓣的第二前部上的第二前锚固耳片。
4.根据权利要求1所述的假体心脏瓣膜，其中所述锚固框架包括具有基本上平坦的前部和圆柱形后部的D形横截面，其中所述平坦的前部防止所述假体心脏瓣膜冲击左心室流出道，并且所述圆柱形后部接合所述天然二尖瓣的后部。
5.根据权利要求1所述的假体心脏瓣膜，其中当所述锚固框架处于所述收缩配置时，所述前锚固耳片和所述多个连合杆彼此嵌套。
6.根据权利要求1所述的假体心脏瓣膜，其中所述前锚固耳片起源于所述锚固框架的圆周上的周向位置，并且其中所述多个连合杆也起源于所述锚固框架的所述圆周上与所述前锚固耳片相同的周向位置。
7.根据权利要求1所述的假体心脏瓣膜，其中所述锚固框架还包括起源于所述多个连合杆的多个弦式缓冲支柱，其中所述多个弦式缓冲支柱被配置用于使天然瓣膜下解剖结构远离所述左心室流出道安置。
8.根据权利要求1所述的假体心脏瓣膜，其中所述多个叉骨形支柱为可变形构件并且允许所述锚固框架在缩回到所述递送导管中时的径向压缩。
9.根据权利要求1所述的假体心脏瓣膜，其中所述锚固元件包括单螺纹连接器、卡扣连接器或叉状连接器。
CN201780021798.XA 2016-01-29 2017-01-27 用于防止流出阻塞的假体瓣膜 Active CN108882981B (zh)

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