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CN111249037A - 人工心脏瓣膜 - Google Patents

人工心脏瓣膜 Download PDF

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CN111249037A
CN111249037A CN202010138482.2A CN202010138482A CN111249037A CN 111249037 A CN111249037 A CN 111249037A CN 202010138482 A CN202010138482 A CN 202010138482A CN 111249037 A CN111249037 A CN 111249037A
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valve
skirt
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struts
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CN111249037B (zh
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T·莱威
S·V·阮
N·贝尼舒
D·迈蒙
Z·哈南
N·古罗维奇
B·费尔森
L·达唐金
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Edwards Lifesciences Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-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
    • 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
    • A61F2250/0036—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 thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

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

Abstract

本申请涉及人工心脏瓣膜。公开了可径向收缩和膨胀的人工心脏瓣膜实施方式。当安装在输送轴上时，瓣膜框架可具有渐缩外形，流入端部分的直径比流出端部分小。瓣膜可包括大致V形小叶，减少了框架流入端中的材料。外裙部可固定至框架的流入端部分的外侧，当瓣膜膨胀时外裙部具有纵向松弛部并且当瓣膜收缩时平实靠着框架。对角线编织的内裙部可与框架一起轴向伸长。邻近小叶的侧突出部可延伸穿过并且固定至框架的窗口框架部分以形成连合部。当瓣膜被压褶在输送轴上时，窗口框架部分相对于周围的框架部分可径向向内凹陷。

Description

人工心脏瓣膜
本申请是分案申请，基于申请号为201810800907.4的分案申请(其又基于申请号为201510850059.4的分案申请)。原申请的申请日为2011年10月5日，中国申请号为201180058439.4，国际申请号为PCT/US2011/054973，发明名称为“人工心脏瓣膜”。
技术领域
本公开涉及人工心脏瓣膜和用于植入心脏瓣膜的输送系统的实施方式。
背景技术
人心脏可遭受各种瓣膜疾病。这些瓣膜疾病可导致心脏的严重机能失常并且最终需要用人造瓣膜替换天然瓣膜。有许多已知的人造瓣膜和许多已知的在人类中植入这些人造瓣膜的方法。
各种外科技术可用于替换或修复患病的或受损的瓣膜。由于狭窄和其他心脏瓣膜疾病，每年数以千计的患者经历外科手术，其中有缺陷的天然心脏瓣膜被人工瓣膜替换。另一不太剧烈的用于治疗有缺陷的瓣膜的方法是通过修复或重建，其通常用在最低限度钙化的瓣膜上。外科手术疗法的问题是对这些慢性病患者施加的与外科手术修复相关的高发病率和死亡率的显著风险。
当替换天然瓣膜时，人工瓣膜的手术植入通常要求开胸手术，在此期间，心脏停止并且患者被安置在体外循环机所谓的“人工心肺机”)上。在一个普通手术过程中，患病的天然瓣膜小叶被切除并且人工瓣膜被缝合至瓣膜环处的周围组织上。因为与该过程和伴随的体外血液循环持续时间有关的损伤，一些患者在外科手术期间不能存活或此后很快死亡。众所周知，患者的风险随着体外循环所需的时间量增加。由于这些风险，大量具有缺陷瓣膜的患者被认为是不宜手术的，因为他们的情况太虚弱而不能承受该过程。通过一些估计，大于50％80岁以上的遭受瓣膜狭窄的受治疗者不能进行瓣膜替换手术。
因为与常规心脏直视手术相关的缺点，经皮和微创外科手术方法引起高度关注。在一种技术中，人工瓣膜配置为通过导管插入在侵害性低得多的程序中植入。例如，通过引用在此并入的美国专利号5,411,522和6,730,118描述可收缩经导管心脏瓣膜，其可经皮以压缩状态在导管上引入并且通过气囊充气或通过使用自膨胀框架或支架在期望的位置膨胀。
经导管心脏瓣膜的重要设计参数是折叠或压褶外形的直径。压褶外形的直径是重要的，因为其直接影响医师引导经导管心脏瓣膜通过股动脉或静脉的能力。更具体地，较小的轮廓允许以增强的安全性治疗更多人数的患者。
发明内容
本公开涉及与人工瓣膜比如心脏瓣膜相关的方法和装置、输送装置和安装在输送装置上的心脏瓣膜的套件。
用于在患者体内植入人工心脏瓣膜的套件的示例性实施方式包括输送装置，其包括细长轴和在轴上以径向收缩构造安装以便输送入身体的可径向膨胀的人工心脏瓣膜。人工心脏瓣膜包括具有流入端部分和流出端部分的环形框架，和位于框架内的小叶结构。框架的流入端部分的外径小于框架的流出端部分的外径。流入端减小的直径可能是由于位于框架流入端部分内的减小的材料量。流入端部分处减小的直径可为位于流入端部分周围的外裙部腾出空间。
在一些实施方式中，心脏瓣膜可进一步包括布置在框架的流入端部分的外表面周围的外裙部，使得人工瓣膜流入端部分的外径——包括外裙部在内——仍小于或等于人工瓣膜流出端部分的外径。
在一些实施方式中，小叶结构可包括多个小叶，其每个包括小叶相对侧上的相对的侧突出部。侧突出部可固定至框架的流出端部分。每个小叶可进一步包括自由的流出边缘部分，其在邻近框架流出端的侧突出部之间延伸；和流入边缘部分，其在邻近框架流入端的侧突出部之间延伸。流入边缘部分可包括相对的轴向边缘部分，其从侧突出部朝着流入端沿大致轴向方向延伸；和中间边缘部分，其在轴向边缘部分之间延伸。中间边缘部分可包括邻近框架的流入端的弯曲顶端部分，和一对倾斜部分，其在轴向边缘部分和顶端部分之间延伸。倾斜部分比顶端部分可具有更大的曲率半径，形成大致V形小叶。
在一些实施方式中，框架包括多个成角度间隔开的连合部窗口，每个包括在第一和第二轴向定向的侧支柱之间的闭合开孔。在这些实施方式中，小叶结构包括多个小叶，每个包括两个相对的侧突出部，每个侧突出部与邻近小叶的邻近侧突出部配对以形成小叶结构的连合部。每个连合部径向向外延伸穿过框架的对应连合部窗口至框架外的位置并且缝合至连合部窗口的侧支柱。在这些实施方式的一些中，当人工瓣膜在轴上为收缩构造时，框架的连合部窗口相对于在邻近连合部窗口之间延伸的框架部分径向向内凹陷。
在一些实施方式中，框架包括在框架流入端部分的流入行开孔、在框架的流出端部分的流出行开孔、和在流入行开孔和流出行开孔之间的至少一个中间行开孔。流入行开孔的开孔大于所述至少一个中间行开孔的开孔。
在一些实施方式中，当在轴上为收缩构造时，小叶结构的部分突出穿过框架中的开孔。
在一些实施方式中，框架的流入端部分包括框架厚度，其小于在流入端部分和流出端部分之间的框架中间部分的框架厚度。
本文公开的实施方式可包括可植入的人工瓣膜，其可径向收缩至收缩构造并且可径向膨胀至膨胀构造。这种人工瓣膜可包括环形框架、位于框架内的小叶结构和位于框架的外表面周围的环形外裙部。外裙部可包括在第一位置固定至框架的流入边缘、在第二位置固定至框架的流出边缘和在流入边缘和流出边缘之间的中间部分。当瓣膜为膨胀构造时，外裙部的中间部分包括沿轴向方向在外裙部的流入边缘和外裙部的流出边缘之间的松弛部，并且当瓣膜收缩至收缩构造时，在外裙部的流入边缘和外裙部的流出边缘之间的轴向距离增加，减小了外裙部中沿轴向方向的松弛部。
在这些实施方式的一些中，当瓣膜径向收缩至收缩构造并且从外裙部的中间部分消除松弛部时，外裙部不沿轴向方向伸展。
可植入的人工瓣膜的一些实施方式包括环形框架，其包括多个小叶附接部分；和位于框架内并且固定至框架的小叶附接部分的小叶结构。小叶结构包括多个小叶，每个小叶包括主体部分、从主体部分的相对侧延伸的两个相对的主侧突出部和邻近主侧突出部的从主体延伸的两个相对的次突出部。次突出部围绕径向延伸的折痕折叠以使次突出部的第一部分平实靠着各自小叶的主体部分，并且次突出部围绕轴向延伸的折痕折叠以使次突出部的第二部分在与第一部分不同的平面上延伸。每个次突出部的第二部分缝合至各自的主突出部并且次突出部位于框架的内部。
在这些实施方式的一些中，当瓣膜收缩至径向收缩构造时，每个次突出部的第一部分围绕轴向延伸的折痕枢转并且平实靠着次突出部的第二部分。每个次突出部的第一部分包括与框架的内表面径向间隔的内边缘，并且当瓣膜在患者体内操作时，响应于流过瓣膜的血液，小叶的主体部分围绕小叶的两个次突出部的内边缘枢接。
本文公开的一些实施方式包括可植入的人工瓣膜，其可径向收缩至收缩构造并且可径向膨胀至膨胀构造。人工瓣膜包括具有流入端部分和流出端部分的环形框架、位于框架内的小叶结构和位于框架内的环形内裙部。内裙部固定至框架的内侧并且内裙部包括第一组线与第二组线的织物，第一组线和第二组线都不与瓣膜的轴向方向平行。当瓣膜从膨胀构造收缩至收缩构造时，框架的轴向长度增加并且第一组线和第二组线都朝着瓣膜的轴向方向旋转，使得内裙部沿轴向方向与框架一起伸长。
在这些实施方式的一些中，当瓣膜为膨胀构造时，第一组线基本上垂直于第二组线。在一些实施方式中，第一组线与瓣膜的轴向方向形成第一角度，并且第二组线与瓣膜的轴向方向形成第二角度，第一和第二角度基本上相等。在这些实施方式的一些中，第一组线和第二组线包括20旦纱。
可植入的人工瓣膜的一些实施方式包括可径向收缩和膨胀的环形框架，其包括多个成角度间隔开的连合部窗口，每个包括在第一和第二轴向定向的侧支柱之间的闭合开孔。瓣膜也包括小叶结构，其位于框架内并且包括多个小叶，每个小叶包括两个相对的侧突出部。每个侧突出部与邻近小叶的邻近侧突出部配对，以形成小叶结构的连合部。每对侧突出部径向向外延伸通过相应的连合部窗口至框架外的位置，位于框架外的突出部的部分沿圆周彼此远离地并且沿着侧支柱的外部表面延伸。瓣膜进一步包括多个楔形部，每个楔形部位于连合部窗口的侧支柱之间并且将延伸通过连合部窗口的侧突出部对分开，楔形部被迫使径向向内靠着侧突出部。
楔形部可在轴向方向上伸长并且轴向长度与连合部窗口侧支柱的轴向长度一致。楔形部可进一步限制侧突出部对相对于连合部窗口的旋转运动。每个楔形部可缝合至柔性加固片，柔性加固片也缝合至每对侧突出部，并且每个可缝合至侧突出部对。楔形部可包括非金属材料，比如缝合材料。
从下面的详细描述中，本发明的上述和其他目的、特征和优势将变得更清楚，参考附图进行详细描述。
附图说明
图1-3显示人工心脏瓣膜的示例性实施方式。
图4-10显示图1的心脏瓣膜的示例性框架。
图11-15B显示用于人工心脏瓣膜的另一示例性框架。
图16A和16B显示图1的心脏瓣膜的示例性内裙部。
图17显示压缩(压褶)条件下的框架变形的人工心脏瓣膜的另一实施方式。
图18显示处于压缩状态并且安装在示例性气囊导管上的图1的心脏瓣膜。
图19-20显示图16A的内裙部与图4的框架的套件。
图21-28显示示例性小叶结构的套件。
图29-35显示小叶结构的连合部部分与框架的窗口框架部分的套件。
图36-40显示沿着小叶的下边缘，小叶结构与内裙部的套件。
图41显示向外展平的示例性外裙部。
图42和43显示图1的示例性人工心脏瓣膜。
图44-48显示人工心脏瓣膜的可选实施方式。
图49-52显示框架的可选实施方式的部分。
图53显示处于径向压缩状态的图4的框架的部分。
图54显示图4的框架的横截面轮廓，其显示从流出端至流入端大致渐缩。
图55显示处于展开、平坦构造的图4的框架。
图56显示处于压缩状态并且安装在示例性气囊导管上的图1的心脏瓣膜。
图57和58显示具有大致V形构造的小叶的实施方式。
图59显示具有可变厚度框架的人工瓣膜的可选实施方式的横截面视图。
图60是在将小叶结构安装至框架之前具有连合部窗口的瓣膜框架的实施方式的侧视图。
图60A是图60的一个连合部窗口的放大侧视图。
图61是包括图60的框架和安装至瓣膜的小叶结构的人工瓣膜的实施方式的透视图。
图62是图61的瓣膜的一个连合部的放大侧视图。
图63-71是图61的瓣膜的连合部的横截面视图，其显示用于将一对小叶侧突出部使用加固片缝合至连合部窗口的各种技术。
图72-74显示框架的可选实施方式的气囊膨胀，其用于具有减小厚度的流入和流出端部分的人工瓣膜。
具体实施方式
根据一种实施方式，图1-3显示人工心脏瓣膜10的各种视图。图解的瓣膜适合植入在天然主动脉环中，尽管在其他实施方式中其可适合植入在心脏的其他天然环中。瓣膜10可具有4个主要部件：支架或框架12、瓣膜结构14、内裙部16和外裙部18。
瓣膜结构14可包括共同形成小叶结构的3个小叶40，其可布置为以三尖瓣布置的塌缩，如图2中最佳显示。小叶结构14的下边缘期望地具有波浪形、弯曲扇形形状(图1中显示的缝合线154顺着小叶结构的扇形形状)。通过形成具有该扇形几何形状的小叶，小叶上的应力减小，其又提高瓣膜的耐久性。而且，由于扇形形状，在每个小叶中部(每个小叶的中间区域)的折痕和波纹可被消除或至少最小化，折痕和波纹可在那些区域造成早期钙化。扇形几何形状也减少用于形成小叶结构的组织材料的量，从而在瓣膜流入端允许更小、更平的压褶外形。小叶40可由心包组织(例如，牛心包组织)、生物相容性合成材料或各种其他合适的天然或合成材料形成，如本领域已知和在美国专利号6,730,118中描述的，其通过引用并入本文。
裸露框架12显示在图4中。框架12可由多个圆周上间隔开的狭孔或连合部窗口20(在图解的实施方式中是3个)组成，其适于将瓣膜结构14的连合部安装至框架，如下面更详细描述的。框架12可由本领域已知的各种合适的塑性膨胀材料(例如，不锈钢等)或自膨胀材料(例如，镍钛诺)的任一种制造。当由塑性膨胀的材料构建时，框架12(以及因此瓣膜10)可在输送导管上压褶为径向压缩状态，然后在患者内通过可充气的气囊或等效膨胀机构膨胀。当由自膨胀材料构建时，框架12(以及因此瓣膜10)可压褶为径向压缩状态并且通过插入输送导管的鞘或等效机构保持在压缩状态。一旦在体内，瓣膜可从输送鞘前进，使得瓣膜膨胀至其功能尺寸。
可用于形成框架12的合适的塑性膨胀材料包括但不限于不锈钢、基于镍的合金(例如，钴-铬合金或镍-钴-铬合金)、聚合物或其组合。在具体的实施方式中，框架12由镍-钴-铬-钼合金如MP35NTM(SPS Technologies的商标)组成，其等同于UNS R30035(由ASTMF562-02涵盖)。MP35NTM/UNS R30035包括按重量计35％镍、35％钴、20％铬和10％钼。已经发现，使用MP35N形成框架12提供优于不锈钢的结构效果。具体而言，当MP35N用作框架材料时，在抗径向力和挤压力、耐疲劳和耐腐蚀方面实现相同或更好的性能需要较少的材料。而且，因为需要较少的材料，可减少框架压褶外形，从而提供更小轮廓瓣膜套件，以便经皮输送至体内的治疗位置。
参考图4和5，图解的实施方式中的框架12包括第一下排I的成角度的支柱22，其端到端布置并且在框架的流入端沿圆周延伸；第二排II的沿圆周延伸的成角度的支柱24；第三排III的沿圆周延伸的成角度的支柱26；第四排IV的沿圆周延伸的成角度的支柱28；和第五排V的在框架流出端沿圆周延伸的成角度的支柱32。多个基本上直的轴向延伸的支柱34可用于相互连接第一排I的支柱22与第二排II的支柱24。通过多个轴向延伸的窗口框架部分30(其限定连合部窗口20)和多个轴向延伸的支柱31，将第五排V的成角度的支柱32连接至第四排IV的成角度的支柱28。每个轴向支柱31和每个框架部分30从由两个成角度的支柱32的下端交会处限定的位置延伸至由两个成角度的支柱28的上端交会处限定的另一位置。图6、7、8、9和10分别是图5中由字母A、B、C、D和E表示的框架12的部分的放大视图。
每个连合部窗口框架部分30安放小叶结构14的各自连合部。可见，每个框架部分30在其上端和下端固定至邻近排的支柱以提供强健构造，与已知的用于支撑小叶结构的连合部的悬臂支柱相比，其增强了在瓣膜的周期载荷下的耐疲劳性。该构造能够减小框架壁厚度以实现瓣膜更小的压褶直径。在具体的实施方式中，在内径和外径之间测量的框架12的厚度T(图4)为约0.48mm或更小。
框架的支柱和框架部分共同限定框架的多个开放网眼。在框架12的流入端，支柱22、支柱24和支柱34限定下排的网眼，其限定开孔36。第二、第三和第四排的支柱24、26和28限定两个中间排的网眼，其限定开孔38。第四和第五排的支柱28和32，与框架部分30和支柱31一起，限定上排的网眼，其限定开孔40。开孔40相对大并且尺寸设定为当框架12压褶时小叶结构14的部分突出或凸出进入和/或通过开孔40以使压褶轮廓最小化。
如图7中最佳显示，支柱31的下端在结点或结合点44连接至两个支柱28，和支柱31的上端在结点或结合点46连接至两个支柱32。支柱31的厚度S1可小于结合点44、46的厚度S2。图53显示处于压褶状态的框架12的部分。结合点44、46与结合点64一起防止开孔40完全闭合。图18显示压褶在气囊导管上的瓣膜10。可见，支柱31的几何形状和结合点44、46和64有助于在处于压褶状态的开孔40中产生足够的空间，以使小叶的部分突出(即，凸出)向外通过开孔。这使得瓣膜比假设在所有小叶材料限制在压褶框架内的情形中压褶为相对更小的直径。
框架12配置为防止或至少最小化瓣膜在预定的气囊压力下的可能的过度膨胀，尤其在支撑小叶结构14的框架流出端部分。在一个方面，框架配置为在支柱间具有相对较大的角度42a、42b、42c、42d、42e。角度越大，打开(膨胀)框架所需的力越大。该现象示意性图解在图15A和15B中。图15A显示当框架12为其压缩状态(例如，安装在在气囊上)时的支柱32。当框架被压缩时，支柱末端之间的垂直距离d1最大，当从气囊的充气(或另一膨胀设备的膨胀)施加开孔力时在相反方向上提供作用在支柱末端的力F1和F2之间相对大的力矩。当框架径向膨胀时，支柱末端之间的垂直距离降低至距离d2，如图15B中所描绘的。随着垂直距离降低，力F1和F2之间的力矩也降低。所以，可见随着支柱末端之间的垂直距离和力矩降低，需要相对更大的膨胀力。而且，随着框架膨胀，在支柱末端的应变硬化(变硬)增加，这增加了促使在支柱末端进一步塑性变形所需要的膨胀力。这样，可选择框架的支柱之间的角度以限制在给定打开压力(例如，气囊的充气压力)下框架的径向膨胀。在具体的实施方式中，当框架膨胀至其功能尺寸时，这些角度至少为110度或更大，甚至更具体地，当框架膨胀至其功能尺寸时，这些角度至少为120度或更大。
另外，由于用于使瓣膜膨胀的气囊的“哑铃”作用，框架的流入端和流出端通常倾向于比在框架的中间部分过度膨胀。为了避免小叶结构14的过度膨胀，期望地将小叶结构在上排的支柱32下方固定至框架12，如图1中最佳显示的。图55显示与图5类似的框架12的平视图，但是显示叠加在框架上的线176，以指示小叶40上边缘的位置。因此，在框架的流出端过度膨胀的情况下，小叶结构位于低于可能发生过度膨胀的水平，从而避免小叶结构过度膨胀。
在已知的瓣膜构造中，如果安装小叶太靠近框架远端，当瓣膜被压褶时小叶可向外突出超过框架的流出端。如果安装压褶瓣膜的输送导管包括推向或紧靠瓣膜的流出端的推动机构或止动元件(例如，以便维持压褶瓣膜在输送导管上的位置)，推动元件或止动元件可能损坏延伸超过框架流出端的暴露的小叶。将小叶安装在与框架的流出端178间隔开的位置的另一好处是，当瓣膜被压褶在输送导管上时，如图56中所显示，小叶40不沿着轴向方向突出超过框架的流出端178。这样，如果输送导管包括推向或紧靠瓣膜的流出端的推动机构或止动元件，推动机构或止动元件可接触框架的末端178，而不是小叶40，从而避免损坏小叶。
而且，在图5中可见，框架最下排开孔的开孔36比两个中间排开孔的开孔38相对更大。如图54中所显示，当压褶时，这允许框架呈现总体渐缩的形状，其从在瓣膜流出端的最大直径D1渐缩至在瓣膜流入端的最小直径D2。当压褶时，框架12具有减小直径的区域，其沿着邻近由参考数字174指示的框架流入端的框架部分延伸，其大致对应于由外裙部18覆盖的框架区域。与框架上部(未被外裙部覆盖)的直径相比较，区域174的直径减小，从而外裙部18不增加瓣膜的总体压褶外形。当展开瓣膜时，框架可膨胀至图4中显示的圆筒形状。在一个实例中，当压褶时，26mm瓣膜的框架在瓣膜流出端的直径D1为14French和在瓣膜流入端的直径D2为12French。
图11和12显示可并入瓣膜10的可选框架50。框架50包括多排沿圆周延伸、成角度的支柱52，其在结点或连接部分54和56处彼此连接。最上排的支柱52通过多个轴向延伸的支柱58和连合部窗口框架部分60连接至邻近排的支柱。每个连合部框架部分60限定狭孔或连合部窗口62，以便安装瓣膜结构的各自连合部，如下面更详细描述的。在具体的实施方式中，框架50的厚度T为约0.45mm或更小。图13和14是图12中分别由字母A和B表示的框架部分50的放大视图。
内裙部16的主要功能是帮助将瓣膜结构14固定至框架12，并且通过阻挡血流通过小叶的下边缘下方框架12的开放网眼帮助在瓣膜和天然环之间形成良好密封。内裙部16期望地包括坚韧的、抗撕裂性材料，比如聚对苯二甲酸乙二酯(PET)，尽管可使用各种其他的合成或天然材料。裙部的厚度期望地小于6密耳，和期望地小于4密耳，甚至更期望地为约2密耳。在具体的实施方式中，裙部16可具有可变的厚度，例如，裙部可在其边缘比在其中央更厚。在一种实施中，裙部16可包括PET裙部，其厚度在其边缘为约0.07mm，并且在其中央为约0.06mm。较薄的裙部可提供较好的压褶性能，同时仍提供良好的瓣膜周围的密封。
裙部16可通过缝合线70固定至框架12的内部，如图39中所显示。瓣膜结构14可经下面讨论的一个或多个薄的PET加强带72附接至裙部(其可共同形成衬套)，其确保可靠的缝合并且避免小叶结构的心包组织撕裂。瓣膜结构14可夹在裙部16和薄的PET带72之间，如图38中所显示。将PET带和小叶结构14固定至裙部16的缝合线154，可为任意合适的缝合线，比如Ethibond缝合线。缝合线154期望地沿着小叶结构14的底部边缘的曲率，如下面更详细地描述。
已知的织物裙部包括经纬纤维的织物，其彼此垂直延伸并且一组纤维垂直于裙部的上边缘和下边缘延伸。当织物裙部所固定至的金属框架径向压缩时，框架的总体轴向长度增加。遗憾的是，固有地具有有限弹性的织物裙部不能与框架一起伸长并因此往往使框架的支柱变形并且阻碍了均匀压褶。
图17显示压褶瓣膜的例子，其中由于具有垂直于裙部的上边缘和下边缘延伸的纤维的裙部，支柱已经在数个地方变形，如参考数字100所指示。而且，在某些位置织物往往成束或形成过多材料的凸起，这限制了最小压褶外形并且阻碍了均匀压褶。
参考图16B，与已知的织物裙部相对照，裙部16期望地由第一组的纤维、或纱或线78和第二组的纤维、或纱或线80编织，其二者都不垂直于裙部的上边缘82和下边缘84。在具体的实施方式中，第一组的纤维78和第二组的纤维80以相对于上边缘和下边缘82、84约45度的角延伸。裙部16可通过以相对于织物的上边缘和下边缘45度角编织纤维形成。可选地，裙部可从垂直编织的织物(其中纤维垂直于材料边缘延伸)对角线切割，从而纤维以相对于裙部上切割边缘和下切割边缘45度角延伸。如图16B中进一步显示，裙部的相对短边缘86、88期望地不垂直于上边缘和下边缘82、84。例如，短边缘86、88期望地以相对于上边缘和下边缘约45度角延伸并且因此与第一组的纤维78对齐。所以裙部的总体形状是长斜方形形状。
图19A和19B显示在相对的边缘部分90、92已经缝合在一起以形成裙部的环形形状之后的裙部16。如所显示，边缘部分90可相对于相对的边缘部分92以重叠的关系布置，并且两个边缘部分可用平行于边缘86、88对角线延伸的缝合线94缝合在一起。裙部16的上边缘部分可由多个突出96形成，所述突出96限定大致跟随紧邻轴向支柱31下端的第四排支柱28形状的波形形状。以该方式，如图20中最佳显示，裙部16的上边缘可用缝合线70紧密固定至支柱28。裙部16也可形成有缝隙98，以便于裙部附接至框架。缝隙98的尺寸为使得裙部的上边缘部分部分地包裹支柱28并且降低附接过程期间裙部中的应力。例如，在图解的实施方式中，裙部16放置在框架12的内部并且裙部的上边缘部分包裹支柱28的上表面，并且用缝合线70固定至合适的位置。以该方式将裙部的上边缘部分包裹支柱28提供裙部更强和更耐久地附接至框架。裙部16也可用缝合线70分别固定至第一、第二和第三排的支柱22、24和26。
再次参考图16B，由于纤维相对于上边缘和下边缘的取向，裙部可沿轴向方向(即，从上边缘82至下边缘84的方向)经历更大伸长。
因此，当金属框架12压褶(如图18中所显示)时，裙部16可沿轴向方向与框架一起伸长并因此提供更均匀的和可预测的压褶外形。在图解的实施方式中金属框架的每个网眼包括至少4个成角度的支柱，其朝着轴向方向旋转(即，成角度的支柱与框架的长度更加对齐)。每个网眼的成角度支柱用作在支柱相同的方向使裙部的纤维旋转的机构，使得裙部沿着支柱的长度伸长。这使得裙部更加伸长并且避免瓣膜被压褶时支柱不期望的变形。
另外，编织的纤维或纱之间的间隔可增加以便于裙部沿轴向方向伸长。例如，对于由20旦纱形成的PET裙部16，纱密度可小于常规PET裙部约15％至约30％。在一些实例中，裙部16的纱间隔可从每英尺约155纱至每英尺约180纱，比如每英尺约160纱，而在常规PET裙部中，纱间隔可从每英尺约217纱至每英尺约247纱。倾斜的边缘86、88促进织物材料在压褶期间沿着框架的内圆周均匀的和一致的分布，从而使织物的成束最小化，以促进均匀压褶为最小可能直径。另外，以垂直方式切割对角缝合线可能沿着切割边缘留下松弛须边。倾斜的边缘86、88帮助最小化这种情况的发生。如上面所述，图17显示具有常规裙部的压褶瓣膜，其纤维垂直于裙部的上边缘和下边缘。比较图17和18，显见裙部16的构造避免了框架支柱不期望的变形并且提供更均匀的框架压褶。
在可选的实施方式中，裙部可由编织的弹性纤维形成，所述弹性纤维可沿轴向方向在瓣膜的压褶期间伸展。经纬纤维可垂直和平行于裙部的上边缘和下边缘，或可选地，它们可相对于裙部的上边缘和下边缘以0和90度之间的角度延伸，如上述。
内裙部16可在远离缝合线154的位置缝合至框架12，从而裙部在该区域可能更柔软(见图28)。这可避免应力集中于将小叶的下边缘附接至裙部16的缝合线154。
如上所述，图解的实施方式中小叶结构14包括3个柔软的小叶40(尽管可使用更多或更少数量的小叶)。如图21中最佳显示，图解的构造中每个小叶40具有上(流出)自由边缘110，其在小叶相对侧的相对上突出部112之间延伸。每个上突出部112下方有缺口114，其将上突出部与相应的下突出部116分开。在下突出部116各自末端之间延伸的小叶下(流入)边缘部分108包括在小叶对侧的垂直或轴向边缘部分118，其从相应的下突出部116向下延伸；和基本上V形的中间边缘部分120，其在小叶的下端具有平滑的、弯曲顶端部分119和一对倾斜部分121，倾斜部分121在轴向边缘部分和顶端部分之间延伸。倾斜部分可具有比顶端部分更大的曲率半径。每个小叶40可具有加强带72，其固定(例如，缝合)至下边缘部分108的内表面，如图22中所显示。
小叶40可在它们的邻近侧彼此固定以形成小叶结构的连合部122。多个柔性连接器124(其之一显示在图23中)可用于将成对小叶邻近侧相互连接并且将小叶安装至连合部窗口框架部分30。柔性连接器124可由编织的PET织物片形成，尽管可使用其他合成和/或天然材料。每个柔性连接器124可包括楔形部126，其在连接器中央从下边缘延伸至上边缘。楔形部126可包括非金属材料，比如绳索或Ethibond 2-0缝合材料片，用临时缝合线128固定至连接器。楔形部126帮助防止在将它们固定至连合部窗口框架部分30时小叶突出部的旋转运动。连接器124可具有沿着其上边缘和下边缘形成的一系列内缺口130和外缺口132。
图24显示通过柔性连接器124相互连接的两个小叶40的邻近侧。柔性连接器124的相对端部分可与下突出部116以重叠关系放置，内缺口130与突出部116的垂直边缘对齐。每个突出部116可通过沿着从下边缘上的外缺口132延伸至连接器上边缘上的外缺口132的线进行缝合而固定至柔性连接器124的相应末端部分。3个小叶40可使用3个柔软的连接器124端到端地彼此固定，如图25中所显示。
现参考图26和27，两个小叶的相邻子连合部部分118可直接彼此缝合。在显示的实例中，PTFE-6-0缝合材料用于形成贯穿(in-and-out)缝线133和梳状缝线134，其延伸穿过两个小叶上的子连合部部分118和加强带72。其余两个邻近的子连合部部分118对以相同方式缝合在一起以形成组合的小叶结构14，其然后可以下列方式固定至框架12。
如上所述，内裙部16可用于帮助将小叶结构14缝合至框架。如图28中所显示，裙部16可具有波浪式临时标记缝合线136，以引导每个小叶40下边缘的附接。裙部16本身可使用缝合线70缝合至框架12的支柱，如上所述，然后将小叶结构14固定至裙部16。与标记缝合线136交叉的支柱期望地不附接至裙部16。这使得裙部16在未固定至框架的区域更柔软并且使沿着将小叶的下边缘固定至裙部的缝合线的应力集中最小化。由矩形140初始划界的裙部16的部分未固定至框架12，并且稍后在小叶结构14固定至裙部之后固定至框架，如下面进一步描述。如上所述，当裙部固定至框架时，裙部的纤维78、80(见图16B)大致与框架成角度的支柱对齐，以促进框架均匀压褶和膨胀。
图29是框架一部分和小叶结构的横截面视图，其显示固定至对应的窗口框架部分30的两个小叶的相邻突出部部分。图30-36显示用于将小叶结构14的连合部部分122固定至框架的连合部窗口框架部分30的一种具体方法。首先，如图30中所显示，固定两个小叶两个邻近侧的柔性连接器124被横向折叠并且上突出部部分112向下靠着柔性连接器折叠。如图30和31中最佳显示，每个上突出部部分112纵向(垂直地)折叠，以呈现L形状，使内部分142靠着小叶的内表面折叠并且外部分144靠着连接器124折叠。外部分144接着可沿着缝合线146缝合至连接器124。接下来，如图31中所显示，连合部突出部套件(由通过连接器124连接的一对下突出部部分116组成)被插入通过相应窗口框架部分30的连合部窗口20。图32是框架12的侧视图，其显示向外延伸穿过窗口框架部分30的连合部突出部套件。
如图29和33中最佳显示，在楔形部126处径向向内挤压连合部突出部套件，从而一个下突出部部分116和连接器124的一部分被靠着框架12折叠在窗口框架部分30的一侧上并且另一个下突出部部分116和连接器124的一部分被靠着框架12折叠在窗口框架部分30的另一侧上。形成了一对缝合线148，以保持下突出部部分116以与图29中显示的相同方式靠着框架12。每个缝合线148延伸穿过连接器124、下突出部部分116、楔形部126和连接器124的另一部分。接着，如图29和34中所显示，每个下突出部部分116用主缝合线150固定至对应的上突出部部分112，所述主缝合线150延伸穿过一层连接器124、下突出部部分116、另一层连接器124、另一层连接器124和上突出部部分112。最后，如图29和35中所显示，用于形成主缝合线150的缝合材料可用于进一步在突出部部分112、116的边缘形成锁边缝线152，其延伸穿过夹在突出部部分112、116之间的两层连接器124。
如图29和30中所显示，向下折叠的上突出部部分112在连合部形成双层小叶材料。上突出部部分112的内部分142被布置为平坦紧邻形成连合部的两个小叶40的层，从而每个连合部仅在窗口框架30内部包括四层小叶材料。连合部的该四层部分可比仅仅从相对更刚性的四层部分径向向内的小叶40部分更抗弯曲或枢接。这使得小叶40响应于在体内操作期间流过瓣膜的血液，主要枢接在向下折叠内部分142的内边缘143，而不是绕窗口框架30的轴向支柱枢接。因为小叶枢接在从窗口框架30径向向内隔开的位置，小叶可避免与框架接触和损坏框架。但是，在强力下，连合部的四层部分可绕邻近窗口框架30的纵轴145(图29)展开，每个内部分142向外折叠靠着各自的外部分144。例如，当瓣膜10被压缩并且安装在输送轴上时，这可能发生，允许更小的压褶直径。当气囊导管在瓣膜的膨胀期间充气时，连合部的四层部分也可绕轴145展开，这可释放由气囊造成的对连合部的一些压力并且因此在膨胀期间连合部未受损。
在所有3个连合部突出部套件分别固定至窗口框架部分30之后，连合部突出部套件之间小叶40的下边缘可缝合至内裙部16。例如，如图36-38中所显示，每个小叶40可使用例如Ethibond线沿着缝合线154缝合至裙部16。缝合线可为贯穿缝合线，其延伸穿过每个小叶40、裙部16和每个加强带72。每个小叶40和各自的加强带72可分别缝合至裙部16。以该方式，小叶的下边缘经裙部16固定至框架12。如图38中所显示，小叶可用锁缝缝合线156进一步固定至裙部，所述锁缝缝合线156延伸穿过每个加强带72、小叶40和裙部16，同时围绕加强带72和小叶40的边缘成环。缝合线156可由PTFE缝合材料形成。图39和40显示在将小叶结构和裙部固定至框架和将小叶结构固定至裙部之后的框架12、小叶结构14和裙部16。
图41显示在外裙部18附接至框架12之前的其平视图。外裙部18可由坚固的、耐久性材料片比如编织的PET激光切割或以其他方式形成，尽管可使用其他合成或天然材料。外裙部18可具有基本上直的下边缘160和上边缘162，其限定多个交替的突起164和缺口166。如图42中最佳显示，裙部18的下边缘160可在瓣膜的流入端缝合至内裙部16的下边缘。如图43中所显示，每个突起164可缝合至框架12的第二横档II支柱24。突起164的角162可折叠在横档II的各自支柱上并且用缝合线168固定。
如在图1、3和43中可见，外裙部18固定至框架12，使得当框架为其膨胀状态时，在外裙部的下边缘和上边缘160、162之间有过多的材料或松弛部，其不平坦靠着框架12的外表面。换句话说，外裙部用过多的材料配置，其在径向膨胀期间随着框架缩短(即，长度变短)造成外裙部向外凸出。所以，当瓣膜10布置在体内时，外裙部18的过多的材料可填充框架12和周围天然环之间的间隙，有助于在瓣膜和天然环之间形成良好的流体密封。所以外裙部18与内裙部16协作，以避免在瓣膜10植入之后瓣膜周围的渗漏。在另一有优势的特征中，外裙部18的下边缘和上边缘之间的松弛部使得框架12在压褶期间轴向伸长，而没有来自外裙部的任何阻力，并且外裙部基本上不影响人工瓣膜在压褶情况下的外径。
图56显示安装在输送装置的细长轴180上的图1-3和42-43的瓣膜10，形成用于在患者体内植入瓣膜10的输送套件。瓣膜10以径向收缩构造安装，以输送进入身体。轴180包括可充气的气囊182，用于使在体内的气囊膨胀，压褶瓣膜10位于放气的气囊上方。当为径向压缩安装构造时，瓣膜10的框架12包括流入端部分174(见图54)，其外径D2小于框架的流出端部分的外径D1。框架的渐缩可至少部分由于V形小叶40，因为与较圆的U形小叶相比，V形小叶在框架12的流入端部分内具有较少的小叶材料。由于框架12处于安装状态的渐缩形状，甚至加上位于框架12的流入端部分174周围的外裙部18的厚度，瓣膜10流入端部分的总外径可大约等于或小于瓣膜流出端部分的总外径。
而且，如图56中所显示，瓣膜10包括小叶的连合部部分，其径向向外延伸通过对应的窗口框架部分30至框架外的位置并且被缝合至连合部窗口框架的侧支柱。为了使瓣膜的压褶外形最小化，当瓣膜在轴上被径向压缩至收缩构造时，窗口框架部分30可相对于框架的周围部分，比如在邻近的连合部窗口之间延伸的框架部分，径向向内凹陷。例如，当瓣膜径向收缩时，相对于在邻近连合部窗口之间延伸的框架部分，框架的连合部窗口30可向内凹陷0.2mm和1.0mm之间的径向距离。以该方式，包括连合部部分的瓣膜流出端部分的外径可大致一致，与从瓣膜的周围部分向外突出的连合部部分——这可妨碍瓣膜输送至身体——相反。甚至由于径向凹陷的连合部窗口框架30，当瓣膜在轴上径向收缩时，框架流入端部分的外径可仍小于或约等于框架流出端部分的外径，允许最低限度的瓣膜的最大总体直径。通过当安装在输送轴上时使瓣膜的直径最小化，套件可容纳在更小直径的导管中并且因此可通过体内更小的脉管并且可通常是微创的。
图44图解根据另一实施方式的人工心脏瓣膜200。心脏瓣膜200包括框架或支架202和安装在支架上的小叶结构204。小叶结构204可包括多个小叶218(例如，如描述的3个)，其可使用合适的技术和/或机构彼此缝合并且缝合至框架202。框架202可适合包括连合部框架部分30(如图4中所显示)，以帮助将小叶缝合至框架。
框架202具备上述框架12的一些设计特征。具体而言，像框架12一样，框架202沿着框架的支撑小叶结构的区域具有相对大的框架开孔206，如图45中所显示。开孔206由在框架流出端的一排成角度的支柱208、多个轴向延伸、沿圆周间隔的支柱210和中间排的成角度的支柱212限定。如所显示，轴向的支柱210期望地比结合点214更薄，所述结合点214将轴向的支柱210的相对端连接至两个支柱212的交会处和两个支柱208的交会处。由于该构造，当瓣膜径向压缩至输送构造时，开孔206的宽度保持足够大以使小叶结构204的部分向外突出穿过开孔，如图46和47中在216指示的。与假设所有的小叶材料限制在压褶框架内相比，这使得瓣膜压褶为相对更小的直径。
为了比较的目的，图48是已知人工瓣膜250的横截面，其显示压褶状态的瓣膜。当瓣膜径向压缩时，邻近的支柱之间的间隔相对小并且不允许小叶结构的部分向外突出穿过框架。结果，限制在框架内部中的所有小叶材料的存在限制了瓣膜的压褶直径。
图49和50显示可选框架构造的平截面，其可允许小叶的部分向外突出穿过压褶状态的框架。该框架构造可在上述瓣膜10中实施。图49显示径向压缩状态的框架截面，而图50显示径向膨胀状态的框架截面。框架(仅仅显示其一部分)包括第一排沿圆周延伸的成角度的支柱442和至少第二排沿圆周延伸的成角度的支柱444。框架中的一些开孔为菱形开孔446，其由在它们的上端彼此连接的邻近支柱442和在它们的下端彼此连接的邻近支柱444形成。框架也包括较大的开孔448，其由在它们的上端与水平支柱450的各自末端连接的邻近的支柱442和在它们的下端与水平支柱452的各自末端连接的邻近的支柱444形成。当框架径向压缩时，水平支柱450、452保持开孔448的宽度W足够大，以允许瓣膜小叶的部分向外突出穿过框架。因此，当框架被压褶时，开孔448的宽度大于开孔446的宽度。框架可形成为开孔446、448围绕框架的圆周交替。可选地，开孔448可位于沿着框架的长度和圆周选择的位置，以对应于小叶材料容易在框架内比如在连合部之间聚集的区域。
图51和52显示另一框架构造的平截面，其可允许小叶的部分向外突出穿过压褶状态的框架。该框架构造可在上述瓣膜10中实施。图51显示径向压缩状态的框架截面，而图52显示径向膨胀状态的框架截面。框架(仅仅显示其一部分)包括第一排沿圆周延伸的成角度的支柱402和至少第二排沿圆周延伸的成角度的支柱404。框架中的一些开孔为菱形开孔406，其由在它们的上端彼此连接的邻近的支柱402和在它们的下端彼此连接的邻近的支柱404形成。框架也包括开孔408，其由在它们的上端连接至扩大的结点或结合点410的邻近的支柱402和在它们的下端连接至扩大的结点或结合点412的邻近的支柱404形成。结合点410、412在那些位置为框架增加了刚性，从而当框架被径向压缩时，开孔408的宽度W保持足够大，以允许瓣膜的小叶部分向外突出穿过框架。因此，当框架被压褶时，开孔408的宽度大于开孔406的宽度。框架可形成为开孔406、408围绕框架的圆周交替。可选地，开孔408可位于沿着框架的长度和圆周的选择位置，以对应于小叶材料容易在框架内比如在连合部之间聚集的区域。
图57显示根据另一实施方式的人工瓣膜(例如，瓣膜10或200)的小叶500。小叶500具有与上述小叶40类似的总体V形。小叶500在小叶的相对侧具有两个突出部部分502，其固定至另一小叶的邻近的突出部部分，以形成小叶结构的连合部。小叶500的子连合部部分(突出部502下方的部分)包括两个基本上直的边缘504，其从正好在突出部502下方的各自位置延伸至弯曲下边缘506。图58显示当瓣膜被压褶时小叶500的大体形状。当被压褶时，框架(未显示在图57-58中)稍微伸长，使得小叶500变得稍微伸长。
小叶的子连合部部分的渐缩外形减少了压褶瓣膜下半部分的小叶材料量，使瓣膜该部分的压褶直径最小化。因此，如果另外的部件安装至瓣膜的该部分，比如外裙部18，瓣膜该部分减小的外形可帮助抵消或最小化由该另外组件引起的直径增加。另外，连合部突出部502相对短并且比已知的小叶设计(比如T形和圆齿形小叶)需要较少的缝合线用于形成小叶结构的连合部，其当瓣膜被压褶时，其更好地分布并且减小了小叶材料的体积。
图59显示根据另一实施方式的瓣膜500的横截面视图。瓣膜500包括框架502、小叶504和安装(例如，通过缝合)至框架502外表面的外裙部18。框架502具有沿着其长度变化的厚度，以在需要时在框架的选择区域优化强度，但使材料最小化(并因此使压褶外形最小化)。在所显示的实施方式中，框架的流出端部分506的最大厚度为T1(从框架该部分的内径至外径测量)并且框架的流入端部分508的最小厚度为T2(从框架该部分的内径至外径测量)。应当注意，形成流出端部分506的框架502的支柱(其未显示在图59中)的厚度为T1和形成流入端部分508的支柱的厚度为T2。框架502可具有与上述框架12相同的构造，除了框架的可变化厚度。厚度减小的区域可使用各种制造技术形成，比如电抛光框架的选择部分(可遮蔽非抛光部分)、打磨框架的选择部分、电火花切割(wire cutting)或其他合适的技术。
流出端部分502大致对应支撑小叶504的连合部并且通常遭受瓣膜最大负荷的框架区域。所以框架的流出端部分502具有选择来提供在预期载荷下的所需强度的更大厚度T1。由于外裙部18，流入端部分508支撑另外的材料层。流入端部分508减少的厚度使得流入端部分压褶为比流出端部分更小的直径。这抵消或最小化了由添加外裙部18造成的压褶直径的增加。
图60-62显示可植入的人工瓣膜310的另一实施方式，其包括小叶结构314和可径向收缩和膨胀的框架312(与图11中所显示的框架50类似)，其具有多个径向间隔的连合部窗口318，用于将小叶结构固定在框架内。瓣膜310也包括裙部316，其固定在小叶结构314框架的内表面312和弯曲下边缘364之间。瓣膜310具有下流入端340和上流出端342。
如图60A中所显示，每个窗口318分别包括两个轴向延伸的侧支柱320之间的闭合开孔334。每个侧支柱包括大致矩形的例如正方形的横截面轮廓，如图63中所显示。每个矩形的侧支柱320包括4个表面：在径向向外面向侧的外部表面324，和在径向向内面向侧的内部表面326，在面向另一侧支柱的一侧的中间表面328，和在远离另一侧支柱的一侧的横向表面330。在其他实施方式中，侧支柱可包括其他横截面形状，比如圆形或六角形。
小叶结构包括多个小叶360，每个包括固定至框架312的一对侧突出部366、固定至裙部316的弯曲下边缘364，和侧突出部和下边缘之间的枢接部分372。每个侧突出部366与另一小叶360的邻近侧突出部配对，以形成小叶结构314的连合部376。每对侧突出部366径向向外延伸通过相应的连合部窗口318至框架外的位置312，并且比如用缝合线固定至窗口的侧支柱320，如图62中所显示。在一些实施方式中，每个侧突出部366包括末端部分368(见图64)和每个连合部376的两个侧突出部末端部分368彼此远离并且沿着窗口318的各自侧支柱320的外部表面324沿圆周延伸。
在一些实施方式中，每个连合部376进一步包括至少一个非刚性加固片378，其缝合至侧突出部366并且缝合至侧支柱320。片378可包括柔性的抗撕裂性材料，包括各种天然和/或合成的生物相容性材料。示例性合成材料可包括聚合物比如尼龙、硅氧烷和聚酯，包括PET。在一个实施例中，片378包括编织的PET织物。
每个加固片378可大体上是矩形的(当放平时)并且可包括中间部分380和相对的末端部分386。在一些实施方式中，该片的第一末端部分386固定至第一侧支柱320和该片的第二末端部分386固定至第二侧支柱320，如图64中所显示。片378将侧突出部366与侧支柱320分开，从而侧突出部不接触侧支柱。例如，片的每个末端部分386可完全包裹各自侧支柱320，如图64中所显示。
侧突出部366和加固片378可在多个阶段固定至侧支柱320。例如，图63显示示例性第一缝合阶段，其中放置片以使片的中间部分380沿圆周延伸横跨侧突出部366末端部分368的外表面并且片的每个末端部分386在各自侧突出部366和各自侧支柱320的各自外部表面、中间表面和内部表面324、328、326之间延伸。片378围绕侧突出部366并且保护侧突出部以免受侧支柱320的边缘影响。一对贯穿缝合线390可将每个侧突出部366和片378的一端固定至各自支柱320。如图63中所显示，每个缝合线390可沿着侧支柱320的侧表面330大致垂直于框架312的圆周定向，并且可在多个不同纵向位置径向来回穿过连合部376。每个缝合线390可与第一层的片378、侧突出部末端部分368、第二层的片和第三层的片交叉，以该顺序径向向内移动。缝合线390将片378固定至侧突出部末端部分368并且将片末端部分386绕侧支柱320紧固，从而将侧突出部366固定至侧支柱320并且将小叶结构314固定至框架312。
图64显示示例性第二缝合阶段，其中第二对缝合线392用于系住加固片378的松弛部分。例如，第二缝合线392可与横向延伸超过第一缝合线390的中间部分380的部分和片的末端部分386交叉。第二缝合线392可为螺旋形锁边缝线，其在多个不同的纵向位置与连合部376交叉，如图62中所显示，并且将片378的松弛部分紧紧靠着侧支柱的侧表面330固定。
第一缝合线390和第二缝合线392二者可邻近支柱320的侧表面330布置，并且间隔远离窗口开孔334。缝合线的这种布置可减少由小叶的枢接部分372的移动引起的缝合上的应力。而是，许多这种应力从小叶的弹性铰链370转移至支柱的内部-中间边缘332附近的侧支柱320。
当小叶在打开和关闭姿态之间枢接时，加固片378避免弹性铰链370受到由支柱320的内部-中间边缘332造成的损坏，如图64中所显示。另外，一些实施方式可也包括位于弹性铰链370和支柱320之间，比如邻近内部-中间边缘332的纵向延伸衬垫带374，如图64中所显示，以进一步避免弹性铰链受到由支柱造成的损坏。衬垫带374可包括柔性的可压缩材料，比如PET织物、心包组织或各种其他生物相容性材料。在一些实施方式中，衬垫带可包括填充了弹性材料的管。例如，衬垫带可包括填充了心包组织的PET管。在其他实施方式中，衬垫带的外部管状覆盖物可由片378形成并且可填充弹性材料。片可围绕弹性材料用缝合线固定，以保持衬垫带适当定位，如图64中所显示。在其他实施方式中，单独的衬垫带374可缝合至加固片378。衬垫带374可具有类似于窗框格62的厚度，以提供侧支柱320和小叶的枢接部分372之间的径向间隙，以防止或最小化在心动周期期间小叶和框架的内表面之间的接触。
图65显示类似于图63和64的实施方式，但具有不同的缝合模式。图65中，缝合线390被缝合线398代替，其围绕侧突出部的末端部分368固定片378。每个缝合线398与片的中间部分380、一个侧突出部366和邻近每个侧支柱的中间-外部边缘324的第二层片交叉。缝合线398可包括贯穿缝线，其在多个不同的纵向位置与连合部交叉。片378的每个末端部分可包括折叠的部分388，其折叠在下面以沿着各自侧支柱320的表面形成双层的片378。缝合线392将紧紧围绕侧支柱的侧表面330的片末端部分386和侧突出部的末端部分368固定。
图66和67显示用于将侧突出部366和片378缝合至侧支柱320的可选方法。图66显示沿着侧支柱的外部表面324布置并且大致垂直于框架的半径的缝合线394。缝合线394与两个侧突出部366和片378的两个末端部分386交叉。缝合线394将片的每个末端部分386分别围绕各自侧支柱320的中间表面、内部表面和侧表面328、326、330紧紧固定，并且也将疏松地围绕侧突出部366的末端部分368的片中间部分380固定。在图66所显示的实施方式中，缝合线394与第一片层A、第二片层B、两个侧突出部366、第三片层C和第四片层D以该顺序交叉。
在第一缝合线394在适当的位置之后，将侧突出部的末端部分368伸展开并且邻近侧支柱320的外部表面324布置，如图67中所显示。这拉紧了围绕侧突出部末端部分368的片的松弛中间部分380。然后一对缝合线396可将片的中间部分380紧紧固定至片的末端部分386，以将侧突出部的末端部分368保持在适当的位置，如图67中所显示。缝合线396可以是环形锁边缝线，其在多个不同的纵向位置与连合部376交叉，与图64中的缝合线392类似。
图68和69显示用于将侧突出部366和片378缝合至侧支柱320的另一可选方法。图68显示缝合线395，其沿着窗口开孔的外侧布置并且大致垂直于框架的半径定向。缝合线395与两个侧突出部366和片378的两个部分交叉。缝合线395固定片的中间部分380，该中间部分围绕侧突出部366的末端部分368松弛延伸。在图68中显示的实施方式中，缝合线395与第一片层A、第一侧突出部B、第二侧突出部C和第二片层D以该顺序交叉。
在第一缝合线395在适当的位置之后，将侧突出部的末端部分368伸展开并且邻近侧支柱320的外部表面324布置，如图69中所显示。这使得围绕侧突出部末端部分368的片的松弛中间部分380拉紧。然后一对缝合线397可将片的中间部分380紧紧固定至片的末端部分386，以将侧突出部的末端部分368保持在适当的位置，如图69中所显示。片的末端部分386可包括折叠在下面的部分388，形成双层片材料，以加固缝合线397。缝合线397可以是环形锁边缝线，其与连合部376在多个不同的纵向位置交叉，与图62中的缝合线392类似。
图70和71显示用于将侧突出部366和片378缝合至侧支柱320的又一可选方法。图70显示缝合线395，其沿着窗口开孔的外侧布置并且大致垂直于框架的半径定向。缝合线395与两个侧突出部366和片378的4个部分或层交叉。片的每个末端部分386包括折叠的部分388，其在侧突出部366和侧支柱的中间表面328之间形成双层片材料。缝合线395将松弛地围绕侧突出部366的末端部分368的片的中间部分380固定。如图70中所显示，缝合线395的每个缝线与包括层A和B的第一对片层、第一侧突出部C、第二侧突出部D和包括层E和F的第二对片层以该顺序交叉。
在第一缝合线395在适当的位置之后，将侧突出部的末端部分368伸展开并且邻近侧支柱320的外部表面324布置，如图71中所显示。这使得围绕侧突出部的末端部分368的片的中间部分380拉紧。然后一对缝合线397可将片的中间部分380紧紧固定至片的末端部分386，以将侧突出部的末端部分368保持在适当的位置，如图71中所显示。片的折叠部分388形成双层片材料，以加固缝合线397。缝合线397可为环形锁边缝线，其与连合部376在多个不同的纵向位置交叉，与图62中的缝合线392类似。
用于将小叶结构314附接至图61-71中显示的窗口框架318的连合部各种构造也可用作将图1-3瓣膜10的小叶结构14附接至框架12的窗口框架部分30的可选方式。
图72-74显示人工心脏瓣膜套件600，其包括人工瓣膜的框架602的实施方式，安装在输送轴604的气囊606上。框架602的形状可与框架12类似并且可包括流入端部分610、流出端部分612和中间部分614。为了清楚，未显示瓣膜的其他组件，比如小叶和裙部。相对于中间部分614的厚度，框架602在流入端部分610和流出端部分612可具有减小的厚度。由于较薄的末端部分，当气囊606充气时，末端部分610、612对膨胀提供较小的阻力并且比中间部分614更快膨胀，如图73中所显示。因为末端部分比中间部分膨胀更快，框架602被限制在气囊606上，抑制框架朝着气囊的任一端滑动并且减少框架过早滑动脱离气囊的风险。如图74中所显示，气囊的进一步充气可引起框架的中间部分614膨胀至与末端部分610、612相同的最终直径，以便植入，其后气囊可被放气和移除。在输送期间控制瓣膜在气囊上的位置可能是重要的，尤其是在膨胀期间缩短并且相对于气囊移动的框架。在图72-74中显示的实施方式中，框架的中间部分614可相对于气囊保持恒定，同时由于气囊的“哑铃”作用，两个末端部分朝着中间部分缩短。任何常规方式可用于生产在末端部分610、612具有减小厚度的框架602，比如用砂纸打磨末端部分或类似方式。在一种实施方式中，框架的末端部分610、614的厚度为约0.37mm，而中间部分614的厚度为约0.45mm。
鉴于应用所公开的发明原理的许多可能实施方式，应当认识到图解的实施方式仅仅是本发明的优选实施例并且不应看作限制本发明。而是，本发明的范围由所附权利要求限定。因此我们要求保护在这些权利要求范围内的我们的所有发明。

Claims (12)

1.用于在患者体内植入可气囊膨胀的人工主动脉心脏瓣膜的套件，其包括：
包括细长轴(180)的输送装置，所述细长轴具有可充气的气囊(182)，和
人工主动脉心脏瓣膜(10)，所述人工主动脉心脏瓣膜(10)包括可气囊膨胀的框架(12)，所述框架(12)具有径向收缩状态和径向膨胀状态，所述框架(12)包括：
在所述框架(12)的流入端部分处的流入行开孔(36)，
在所述框架(12)的流出端部分处的流出行开孔(40)；和
在所述流入行开孔(36)和所述流出行开孔(40)之间的至少一个中间行开孔(38)；
其中所述流出行开孔(40)由端到端布置的沿圆周延伸的上排成角度支柱(32)和端到端布置的沿圆周延伸的中间排成角度支柱(28)形成，所述上排成角度支柱和中间排成角度支柱(28、32)通过多个轴向延伸的支柱(31)和多个成角度间隔开的轴向延伸的连合部窗口框架部分(30)相互连接，其中每个轴向延伸的支柱(31)的上端和每个连合部窗口框架部分(30)的上端连接至结合点(46)，所述结合点(46)由所述上排成角度支柱(32)的两个成角度支柱(32)的下端的交会处限定，并且每个轴向延伸的支柱(31)的下端和每个连合部窗口框架部分(30)的下端连接至结合点(44)，所述结合点(44)由所述中间排成角度支柱(28)的两个成角度支柱(28)的上端的交会处限定；和
其中所述多个连合部窗口框架部分(30)各自包括在第一和第二轴向定向的侧支柱之间的封闭开孔(20)，
所述人工主动脉心脏瓣膜(10)还包括：
位于框架(12)内的环形内裙部(16)，所述内裙部(16)固定至所述框架(12)的内部，和
位于所述框架(12)内的小叶结构(14)，所述小叶结构(14)包括多个小叶(40)和多个连合部部分，所述连合部部分向外延伸穿过对应的连合部窗口框架部分(30)，其中所述多个小叶(40)中的每一个包括具有扇形形状的下边缘，所述下边缘在所述小叶结构(14)的对应连合部之间被缝合到所述内裙部(16)。
2.根据权利要求1中所述的套件，其中流出行开孔(40)的开孔(40)大于所述流入行开孔(36)和所述至少一个中间行开孔(38)的开孔(36、38)。
3.根据前述权利要求中的一项所述的套件，其中当所述框架处于径向膨胀状态时，所述框架(12)的相邻成角度支柱形成至少120°的角度。
4.根据前述权利要求中的一项所述的套件，其中在所述框架的内径和外径之间测量的所述框架(50)的厚度(T)为约0.48mm或更小，优选约0.45mm或更小。
5.根据前述权利要求中的一项所述的套件，其中成角度支柱排的两个相邻成角度支柱(24)的下端通过具有U形的接合部连接，并且成角度支柱排的两个相邻成角度支柱(22)的上端通过具有倒U形的接合部连接。
6.根据前述权利要求中的一项所述的套件，其中所述流出行开孔(40)的每个轴向延伸的支柱(31)具有厚度(S1)，所述厚度(S1)小于由所述中间排成角度支柱(28)的两个成角度支柱(28)的上端的交会处限定的结合点(44)和由所述上排成角度支柱(32)的两个成角度支柱(32)的下端的交会处限定的结合点(46)的厚度(S2)。
7.根据前述权利要求中的一项所述的套件，其中所述内裙部(16)的上边缘缝合到所述第二中间排成角度支柱(28)，其中所述内裙部(16)的上边缘形成有多个突出(96)，所述突出(96)限定大致跟随所述中间排成角度支柱(28)的形状的波形形状。
8.根据前述权利要求中的一项所述的套件，所述人工主动脉心脏瓣膜(10)还包括环形外裙部(18)，所述环形外裙部(18)包括在第一位置处固定到所述框架(12)的流入边缘和在第二个位置处固定到所述框架(12)的流出边缘。
9.根据权利要求8所述的套件，其中所述外裙部(18)具有上边缘(162)，所述上边缘(162)限定多个交替的突起(164)和缺口(166)，所述突起(164)固定到所述第二位置，所述外裙部(18)在所述缺口处不固定到所述框架(12)。
10.根据权利要求8或9所述的套件，其中所述外裙部(18)具有在所述瓣膜的流入端处缝合到所述内裙部(16)的下边缘的基本直的下边缘(160)。
11.根据前述权利要求中的一项所述的套件，其中所述小叶结构(14)在上排成角度支柱(32)下方固定至所述框架(12)。
12.根据前述权利要求中的一项所述的套件，其中所述框架(12)包括选自不锈钢和钴铬合金的材料。
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DE202011111130U1 (de) 2020-05-27
ES2880607T3 (es) 2021-11-25
CA2813419C (en) 2019-12-17
HRP20210684T1 (hr) 2021-06-11
ES2879553T3 (es) 2021-11-22
HRP20210771T4 (hr) 2024-10-11
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