CN112437649A - 心脏瓣膜假体 - Google Patents

心脏瓣膜假体 Download PDF

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Publication number
CN112437649A
CN112437649A CN201880095776.2A CN201880095776A CN112437649A CN 112437649 A CN112437649 A CN 112437649A CN 201880095776 A CN201880095776 A CN 201880095776A CN 112437649 A CN112437649 A CN 112437649A
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annular portion
heart valve
valve prosthesis
prosthesis
strut
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菲利斯·朱塞佩·卡利诺
马尔科·布索内
弗朗西斯科·瓦莱
莫妮卡·弗朗西斯卡·阿基卢齐
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Kexin Co.,Ltd.
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Sorin Group Italia SRL
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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
    • A61F2/2409—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
    • 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
    • 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
    • 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

Abstract

心脏瓣膜假体包括用于将瓣膜假体锚定在植入部位的防护件。该防护件限定了用于使血流通过的内腔并且具有纵轴线，以及一组人工瓣膜小叶，该一组人工瓣膜小叶由所述防护件支撑并构造成在径向展开的状态下在血液流动的作用下移动以使血液能够沿第一方向流动通过所述内腔，以及在径向收缩的状态下移动，其中所述瓣膜小叶相互配合并沿与所述第一方向相反的方向阻止血液流动通过假体。所述防护件包括环形部分以及由所述环形部分承载的拱形支柱的图案，所述拱形支柱的图案具有连接到所述环形部分的近端以及与所述近端轴向间隔开并且与所述环形部分相对的远端，多组锚固结构，其构造成从所述环形部分径向向外突出，每组由所述环形部分和相应的拱形支柱中的至少一个支撑，以及多个支撑柱，每个支撑柱由相邻的拱形支柱支撑，其中多组锚固结构与支撑柱围绕所述纵轴线交替。

Description

心脏瓣膜假体
技术领域
本公开涉及心脏瓣膜假体。更具体地，已经参考所谓的“支架式”心脏瓣膜假体开发了本公开，即特征为支撑结构和由该支撑结构承载的人工心脏瓣膜，其中该支撑结构通常被称为“防护件(armature)”，并且提供作为支架构件。
背景技术
一些心脏瓣膜假体包括缝合、缝连或以其他方式永久地连接到防护件的多小叶人工心脏瓣膜，其限定了用于使血液通过假体的内腔。防护件被提供为支架构件，并且因此其展现出广泛的变形能力。通常，支架式心脏瓣膜假体的防护件具有径向塌缩的构造，该构造旨在用于将其输送到植入部位并在植入部位定位(例如，经由诸如导管的输送器械)，以及径向扩张构造，该构造旨在确保假体在植入后被保留在植入部位。
有时，人工瓣膜包括一组人工瓣膜小叶，该一组人工瓣膜小叶由防护件支撑并构造成在径向展开的状态下在血液流动的作用下移动以使血液能够沿第一方向流动通过内腔，以及在径向收缩的状态下移动，其中瓣膜小叶相互配合(所谓的小叶接合)并沿与所述第一方向相反的方向阻止血液流动通过假体。
由于人工瓣膜连接到防护件上，两者之间存在一定程度的结构相互作用，这导致人工瓣膜的操作可能受到防护件在植入过程结束(瓣膜位于植入部位)时所经历的结构条件的影响。植入部位(瓣膜环)的形状可能影响瓣膜的体内功能。例如，D形环可能促进小叶伸直，进而可能最终对小叶接合产生负面影响。通常发生这种情况是因为环的不规则形状，即其偏离了理想的圆形。由于D形环在概念上可以被视为“扁平”的圆形环，因此假体的防护件将在环的整个周边，尤其是在“扁平”的部分上，经历不规则的变形模式。这可导致明显的变化，例如，在其上附接了人工瓣膜的防护件的支柱的相对位置的变化，尤其是可能位于“扁平”侧的两个支撑支柱之间的相互距离的增加。距离的这种增加导致上面提到的小叶伸直，继而易于促进通过假体的血液反流。这显然是不希望的情况，因为不能恢复由假体代替的天然心脏瓣膜的功能，更不用说这可能对已经受苦的患者造成的损害。
另外，可能在假体的防护件上提供的径向突出的锚固结构可能影响在将假体植入二尖瓣环或平坦的Valsalva窦等部位时弯曲的阻力。因此，假体将遭受称为“折叠”的弯曲现象，这是对患者的风险和伤害的另一主要来源。
发明内容
在第一实例中，心脏瓣膜假体包括用于将瓣膜假体锚定在植入部位的防护件。该防护件限定了用于使血流通过的内腔并且具有纵轴线，以及一组人工瓣膜小叶，该一组人工瓣膜小叶由所述防护件支撑并构造成在径向展开的状态下在血液流动的作用下移动以使血液能够沿第一方向流动通过所述内腔，以及在径向收缩的状态下移动，其中所述瓣膜小叶相互配合并沿与所述第一方向相反的方向阻止血液流动通过假体。所述防护件包括环形部分和由所述环形部分承载的拱形支柱的图案，所述拱形支柱的图案具有连接到所述环形部分的近端以及与所述近端轴向相隔且与所述环形部分相对的远端。其中，多组锚固结构构造成从所述环形部分径向向外突出，每组由所述环形部分和相应的拱形支柱中的至少一个支撑，以及多个支撑柱，每个支撑柱由相邻的拱形支柱支撑。其中，多组锚固结构与支撑柱围绕所述纵轴线交替。
在根据第一实例的第二实例中，其中每组锚固结构在对应的拱形支柱和所述环形部分之间以桥状延伸。
在根据第一实例或第二实例的第三实例中，其中每个支撑柱均悬臂至相邻的拱形支柱。
在根据前述实例中的任一个的第四实例中，其中每个拱形支柱从第一近端延伸到远端，然后延伸到第二近端。
在根据第四实例的第五实例中，其中每组锚固结构从拱形支柱以桥状延伸到包括在两个近端之间的所述环形部分的一部分。
在根据第五实例的第六实例中，其中每组锚固结构包括两个锚固结构。
在根据第五实例或第六实例的第七实例中，其中每个锚固结构包括蛇形、编织或带孔图案。
在根据第四实例的第八实例中，其中每个支撑柱在支柱间位置处成角度地布置在两个相邻的拱形支柱之间，所述支柱间位置对应于在所述两个相邻的拱形支柱之间共享的近端的位置。
在根据第三实例或第八实例的第九实例中，其中所述支撑柱通过在支撑柱处合并的第一和第二悬臂支柱而悬臂至所述一对拱形支柱。
在根据前述实例中的任何一个的第十实例中，其中所述环形部分由套带覆盖以在植入部位提供密封，该套带布置在防护件的内腔的外部。
在根据第十实例的第十一个实例中，其中套带与所述一组人工瓣膜小叶分开。
在根据前述实例中的任何一个的第十二实例中，其中所述环形部分包括构造为被瓣膜加载或卷曲设施或器械接合的一个或多个联接元件。
在根据前述实例中的任一个的第十三实例中，其中所述一组人工瓣膜小叶限定了人工主动脉瓣，所述心脏瓣膜假体是主动脉瓣假体。
在根据第一实例的第十四实例中，其中每个拱形支柱在其远端处包括远侧部分，该远侧部分是大致C形的，并且构造成与输送器械的瓣膜保持器或载体部分配合。
在根据第一实例或第十四实例的第十五实例中，其中拱形支柱的图案包括布置在所述近端处的支柱间部分，并且所述环形部分具有包括单元(cell)和节点的网格结构，所述支柱间部分具有延伸穿过所述环形部分的网格的节点的Y形或U形。
在第十六个实例中，心脏瓣膜假体包括：
用于植入部位的瓣膜假体的防护件，
一组由所述防护件支撑的人工瓣膜小叶，
所述防护件包括：
环形部分
连接到所述环形部分的多个拱形支柱，
由相邻的拱形支柱支撑的多个支撑柱，每个具有自由近端和远侧部分。
在根据第十六实例的第十七实例中，还包括多组锚固结构，所述多组锚固结构构造成从所述环形部分径向向外突出，每组由所述环形部分和相应的拱形支柱中的至少一个支撑。
在根据第十六实例的第十八实例中，所述支撑柱悬臂至相邻的拱形支柱。
在根据第十七实例的第十九实例中，每组锚固结构在对应的拱形支柱和所述环形部分之间以桥状延伸。
在根据第十七实例的第二十实例中，所述多组锚固结构与支撑柱围绕假体的纵轴线交替。
尽管公开了多个实施例，但根据以下具体实施方式，本公开的其它实施例对于本领域技术人员将变得显而易见，所述具体实施方式示出并描述了本公开的说明性实施例。因此，附图和具体实施方式本质上应被视为说明性的，而非限制性的。
附图说明
从以下参照附图的描述中，本公开的其他特征和优点将变得显而易见，所述附图仅以非限制性实例的方式给出，其中：
图1A是根据本公开的实施例的心脏瓣膜假体的透视图；
图1B和1C示出了根据本公开的实施例的瓣叶形成构件的修剪部分的实例；
图2是根据本公开的实施例的图1的假体的防护件的透视图；
图3是根据本公开的实施例的根据图2中III的图2的防护件的正交图；
图4是根据本公开的实施例的根据图2中IV的图2的防护件的另一正交图；
图5是根据本公开的实施例的根据图2中V的图2的防护件的另一正交图；
图6是根据本公开的实施例的根据图2中VI的图2的防护件的又另一正交图；和
图7是根据本公开的实施例的心脏瓣膜假体的植入的实例。
尽管本公开可进行各种修改和替代形式，但在附图中已通过实例的方式示出了具体实施例并在下面对其进行了详细描述。然而，其目的并非将本公开限制为所描述的特定实施例。相反，本公开旨在覆盖落入由所附权利要求限定的本公开范围内的所有修改、等同形式和替代形式。
具体实施方式
参考图1A，附图标记1整体上表示根据本公开的各种实施例的心脏瓣膜假体。心脏瓣膜假体1包括用于将瓣膜假体锚定在植入部位的防护件2。防护件2限定用于血流通过的内腔并且具有纵向轴线X1。
假体1还包括一组人工瓣膜小叶4，该一组人工瓣膜小叶由防护件2支撑并构造成在径向展开的状态下在血液流动(其具有大致对应于轴线X1的方向的主流动方向)的作用下移动以使血液能够沿第一方向流动通过内腔，以及在径向收缩的状态下移动，其中瓣膜小叶4相互配合并沿与第一方向相反的方向阻止血液流动通过假体1。这通常称为小叶接合。
参考图2-5，在实施例中，防护件2包括环形部分6，以及由环形部分6承载的拱形支柱8的图案。环形部分具有可以从与将假体输送到植入部位相关的径向收缩状态扩张到其中将假体保持在植入部位的径向扩张状态的结构。在这些实施例中，环形部分可以具有网格结构，该网格结构包括具有多边形形状(六角形、菱形等)的多个支柱簇(单元)的环形图案。
关于一组小叶4(也称为瓣膜套)的构造，在各种实施例中，人工瓣膜由三个独立的小叶组成。从根据图1B(即，根据大体上为叶形图)修剪的一片心包中获得每个小叶。每个修剪的小叶具有缝纫孔SH和两个侧翼SW的两种模式。
模式SH被缝合在一起，形成缝合的较硬的折叠，该折叠在其根部顺着小叶轮廓，从而形成尖端。
两侧翼SW可以将瓣膜连接到瓣膜防护件中的支撑柱。缝合折叠的目的是向内偏压尖端，从而促进小叶接合，并避免防护件2和瓣膜小叶4之间的接触，避免了由于反复冲击防护件2而造成的磨损风险，在一些实施例中防护件是金属材料。
可以使用涂覆有生物相容性材料或PET线或PTFE丝的膜的缝合线将孔SH的两个图案模式缝合在一起。
可以改变缝合图案，以适应在针迹的每个点上施加的力的方向差异，防止针迹触发疲劳断裂线。
优选地，缝合顺着图1C中由字母“C”标识的图案(内外表面缝合交替)。然后，将三个小叶4在侧翼SW处连接并沿着小叶柱线，即在相邻的侧翼SW的界面处缝合在一起，从而形成圆锥形管道。
然后将允许从管道向外突出的材料松弛的侧翼SW固定到防护件柱，该防护件柱由侧翼SW完全包裹。
缝合孔SH下方的多余的组织裙状部允许借助于缝合线将小叶固定至支架的流入环6。另外，在一些实施例中，可以在环形部分6处将图案SH中的一个(优选地，下部的一个或两个)缝合到防护件。
最后，将一条心包带缝到流入环6的外面，从而限定密封套带SC。所述带可以在其流出端上折叠以沿着瓣膜周边提供密封环，或者第二带可以通过周向缝合线连接到第一带，以实现密封周向环。
人工瓣叶4可以具有与作为替换心脏瓣膜的操作兼容的任何数量。在一些实施例中，该组包括一对小叶。在诸如附图所示的一些实施例中，该组包括三个人工瓣膜小叶4(例如用于主动脉瓣膜假体)。在一些实施例中，该组可以包括四个小叶4。
在实施例中，小叶4可以由生物材料制成，例如牛或猪的心包。在其他实施例中，小叶4可以由非生物材料制成，例如具有血液相容性的非生物织造或非织造织物。例如在EP申请EP 16745505.4中公开了其实例。
每个瓣膜小叶4包括具有拱形图案的流体力学近侧边缘4P，其从上部图案SH处的基部并沿着两个相邻的褶皱结构PF延伸，以及流体力学远侧边缘4D，其朝着假体1的中心孔口延伸，以便能够与其他瓣膜小叶4的同源边缘配合。
如本文所用，术语“流体动力学近侧”和“流体动力学远侧”是指血液通过假体的自由流动方向，该方向是自下而上的，如在所附附图板的图中所看到的。
在操作(心动周期)期间，瓣膜小叶4经历变形、展开并朝着防护件2向上移动，以使得血液能够自由流过假体。
当通过假体的血液的压力梯度以及因此流动方向趋于颠倒时，瓣膜小叶4然后移至图1A中表示的位置，在该位置中，它们阻止了血液通过假体的回流。
包括瓣膜小叶4的人工瓣膜可以是例如戊二醛固定的心包瓣膜，其具有向远侧打开以允许单向血液流动的三个尖瓣。
拱形支柱8的图案包括连接到环形部分6的近端10和与近端10轴向间隔开并布置在防护件2的与环形部分6相对的一端的远端12。在实施例中，远端12与防护件2的远端重合，并且在其中防护件2的远端与整个假体1的远端重合的实施例中，远端12也与假体1的远端重合(在附图中所示的至少一些实施例中就是这种情况)。
由于这种布局，在实施例中，假体1包括基本上对应于环形部分6的流入部分IF(无论是否被密封套带SC覆盖)，以及基本上对应于防护件的远侧区域(即远端12的布置之处)的流出部分OF。
防护件2还包括构造成从环形部分6径向向外突出的多组14锚固结构16，每组14由环形部分6和相应的拱形支柱8中的至少一个支撑，以及多个支撑柱18，每个由相邻的拱形支柱8支撑，其中锚固结构16的组14围绕纵轴X1与支撑柱18交替。在实施例中，支撑柱18有利地悬臂至相邻的拱形支柱8，并且被配置为用于人工瓣膜，特别是用于瓣膜的连合点处的褶皱结构PF的固定位置。在这方面，柱18由在人工瓣膜的组装期间预先缝合在一起的相邻侧翼SW包裹。
再次参考图2-5，在实施例中，每个拱形支柱8以谷-峰-谷顺序从第一近端10延伸到远端12，然后延伸到第二近端10，其中谷位于近端10，并且峰位于远端12。在实施例中，拱形支柱的图案包括三个相邻的并且优选地相同的拱形支柱8(例如在附图中)。参考图5和图6，在实施例中，拱形支柱8在防护件2的内表面和外表面的边界内延伸，从而相对于那些表面基本上没有任何突起。在其他实施例中，拱形支柱可从防护件2的内表面和外表面具有偏移，这意味着拱形支柱可从与防护件2的内表面和外表面相切的两个圆柱表面径向向内或径向向外突出(在图6的视图中，这将对应于从防护件2限定的内腔的圆形周边径向向内或径向向外的偏移。
在实施例中，拱形支柱的大小和尺寸设置成在近端10和远端12之间具有可变的曲率，例如，拱形的形状以在近端10处的45度切线开始并以在远端处的80度切线结束，所述角度是相对于平行于轴线X1的方向测量的。
在一些实施例中，拱形支柱8的大小和尺寸设置成在近端10和远端12之间呈现出明显的曲率变化。拱形支柱8的图案包括位于远端12的远侧部分20和位于近端10的支柱间部分22。远侧部分20可以被成形为例如通过呈现如图所示的C形而在支柱的形状中提供明显的局部变化。远侧部分20可为其他装置，例如瓣膜保持器或输送导管的载体部分的毂，提供联接位置。在其他实施例中，可以将远侧部分20设置为闭环结构，例如眼睛或孔眼。还应注意，可以在环形部分6处设置闭环结构(作为防护件2的一部分或在密封套带SC上，例如作为由纱线制成并编织通过套带SC的环)，作为旨在例如通过表面加载或卷曲设施或器械接合的联接元件。
在实施例中，支柱间部分22基本上是V形的，并且由离开同一近端10的相邻拱形支柱的根部限定。在一些实施例中，支柱间部分22可以呈现Y形或U形。在附图(特别是图2-5)中示出了Y形的实例，其中每个支柱间部分22延伸穿过环形部分6的网格。在这些实施例中，环形部分6的网格被设置为在对角线(例如最短的对角线)的端点处顺序地彼此连接的一系列菱形支柱簇(单元)，并且因此在延伸通过连接点序列的圆周的相对侧上呈现出自由端的相同的圆形图案。因此，Y形支柱间部分22一体地形成在两个相邻的菱形支柱簇之间的选定的连接点处，并且延伸得不超过防护件2的近端。
在实施例中，支柱簇可以根据箭头形状布置，即，由由纵向支柱桥接的两个周向同相的轴向交错正弦曲线图案限定。
在实施例中，支撑柱18成角度地布置在支柱间位置，即，圆周位置，其布置在提供了支柱间部分22(以及相应地，提供了由两个相邻的拱形支柱8共享的近端10)的区域处。支撑柱可以设置成悬臂到经由第一悬臂支柱24和第二悬臂支柱26插入支柱间部分22的两个相邻的拱形支柱8，每个支撑柱分别连接到所述相邻的拱形支柱8中的相应一个，如图中所示。在一些实施例中，每个悬臂支柱24、26可以是双支柱。
悬臂支柱24、26从相应的拱形支柱8上的位置开始大约在拱形支柱8的从近端10延伸到远端12的部分的一半处并入每个相应的柱18中。注意，在其他实施例中，支撑柱18可以例如通过与支柱间部分22(在这种情况下将呈现三叉戟形状)一体形成而悬臂至环形部分6。
可以选择形成Y形支柱间部分22的连接点，使得相同部分绕轴线X1均匀地(角度上)间隔。这同样适用于支撑柱18，其可以被布置为围绕轴线X1均匀地(角度上)间隔。
在附图所示的一些实施例中，防护件2包括三个拱形支柱8、围绕轴线X1间隔120°的三个柱18、以及三组14，因此围绕轴线X1的顺序为柱18-组14-柱18-组14-柱18-组14(在这个意义上，即使支柱8和组14的确遵循120度分布)。在实施例中，三组14分别包括一对锚固结构16，其中每组14(以及相应地，每个锚固结构16)在环形部分6和对应的拱形支柱8之间桥式延伸。在实施例中，每对锚固结构16在支柱内位置(即，在拱形支柱8内的位置)桥式延伸，并且因此包括在相同的拱形支柱8的两个近端10之间并且在远端12/远侧部分20下方。换句话说，每组14的锚固结构16从拱形支柱8以桥状延伸到包括在两个近端10之间的环形部分6的一部分。
因此，支撑柱18布置在支柱间位置处(例如，如图所示，在支柱间部分22上方)，使得提供了顺序柱18-组14-柱18-组14-柱18-组14，在位置方面为支柱间–支柱内–支柱间–支柱内–支柱间–支柱内。
在实施例中，支撑柱18设置有孔28，孔28构造成用于接收将连合部分(瓣膜的褶状结构)固定到柱18的缝合线或缝线，从而将人工瓣膜固定到防护件2。在一些实施例中，人工瓣膜被固定到支撑柱18，而其完全在瓣膜的外部。缝合线或缝线从内腔的内部穿过孔28并穿过与相应的柱18接触的瓣膜层。在其他实施例中，柱18可以被瓣膜层包裹，特别是被瓣膜的连合点包裹，使得瓣膜至少部分地在柱18的“外部”。
在实施例中，锚固结构可包括在其相对端之间的蛇形或其他编织部分。这种蛇形或其他编织部分旨在在与Valsalva窦的界面处为锚固结构提供更大的占地面积，并且此外，其使锚固结构鼓胀到大于流入直径的直径，通常为流入直径的1.4倍或1.5倍。
图1A中所示的假体1特别适合作为主动脉瓣假体，即，用于替换主动脉瓣。为此目的，人工瓣膜包括三个相同的小叶4，并且防护件2按照120°间距(或在适当情况下为1/3的覆盖范围)的标准进行整体设计，如上所述：三个柱18相距120°，三组14围绕轴线X1均匀分布，三个拱形支柱8覆盖环形部分6的圆周延伸的大约三分之一。
假体1可以如图7所示植入，使得在环形部分6处的流入部分IF占据相对于Valsalva窦VS的近端位置，包括天然瓣膜环，而锚定结构16延伸到Valsalva窦VS的叶中(每个窦一各组14)以牢固地将假体1固定在适当的位置。拱形支柱8的图案构造成在窦本身的远端处在与升主动脉的界面处遵循Valsalva窦的轮廓。在各种实施例中，远端12的远侧部分20旨在仅位于窦的远侧。
在实施例中，实现假体1的这种放置可以包括根据以下规范(在范围内包括所有端点)确定假体的大小和尺寸：
环状部分6的轴向长度(流入部分IF)：7-10mm；
假体的总轴向长度(例如，从流入部分If的近端到远侧部分20测量)：25-37mm；
流入部分IF的扩张直径(包括密封环SC的环形部分6的外径：23-33mm；以及
在锚固结构的最径向外侧部分处测得的锚固结构16的扩张的外径：31-44mm。
另外，可以根据以下规格确定由防护件2承载的人工瓣膜的大小和尺寸：
心室突出：5-8mm；和
植入直径：19-29mm。
成对的锚固结构16——特别是当如图所示设置有蛇形或其他编织图案时——有利地与窦接触，以通过径向向外凸出防护件2将假体1保持在适当位置。每对的锚定结构16可以有利地位于Valsalva的各个窦中的冠状动脉口的相对侧上，其蛇形或其他通常的编织(或开孔)结构基本上避免了对冠状动脉口的干扰。
根据实施例，假体1的防护件2通过首先从生物相容性金属(例如，镍钛诺或钴铬合金)的管中切割出空部分来制造，其外径处于在完全径向收缩和完全扩张的设备尺寸之间的中间大小。例如，管的外径可以在约10mm至约14mm之间。在一些实施例中，管的直径为约12mm。在一些实施例中，管壁可以在约0.4mm至约0.6mm之间变化，这取决于所需的所需刚度和假体1的尺寸。
在实施方式中，框架的最终尺寸和形状通过一系列的扩张循环来实现。在每个扩张周期之后进行特定的热处理，以使材料均匀化并消除应力，这可以使防护件2的结构的形状和特性固定。尽管形成步骤的数量可以在装置之间变化，但是对于以上关于本公开描述的几何形状，和使用镍钛诺作为管坯，形成步骤的示例性数量大约为三个。在这些步骤中，前两个提供了环形部分6的最终直径。例如，如果用于植入的完全扩张的直径是20.5mm，则防护件2的最终圆柱形状可以使用内径为约12mm的管坯来实现，第一扩张从约12mm至约15mm，第二扩张从约15mm到约19.5mm，第三扩张从约19.5到21.5mm。可选地，可以使最终直径稍大一些(例如，在前面的实例中约为21.5mm)，以使防护件2相对于生理环的尺寸过大，从而在标称植入物直径处向环的壁施加径向力。
所有形成步骤还旨在赋予锚固结构16径向延伸的形状，使得它们将装配并锚固在Valsalva窦内。
在完成形成过程之后，防护件2可以进行一种或多种表面处理，例如喷砂和电抛光，以提供足够光滑的表面并去除浅缺陷。此后，防护件2可以最终暴露于碳涂层过程，以改善其血液相容性。
防护件2的最终几何形状因此将大体上近似于主动脉根的生理形状和尺寸，使得锚固结构16大体上与相应的Valsalva窦VS的壁相符。
假体1以径向收缩的状态被输送到植入部位，例如被卷曲并被装载到诸如导管的输送工具中。可以使用微创技术或通过常规外科手术技术(例如胸骨切开术或开胸术)植入假体。一旦就位，就将假体1从导管中释放出来，以使环形部分6扩张到径向扩张构造，并使锚固结构16沉降到Valsalva窦中。
在实施例中，提供悬臂至拱形支柱8的支撑柱18使假体1的近侧部分(即，环形部分6)的变形模式与同一假体的远侧部分(即，拱形支柱8的会聚到远端12的部分)的变形模式脱离。如果植入部位具有不规则形状(例如D形)，以致导致现有技术的假体的瓣叶功能发生实质性改变，则假体1相反地允许环形部分适应植入部位的形状而无需将由此产生的任何变形传递到支撑柱18，这通过保持间隔120度而基本上将其保持在防护件2上的预期位置。在主动脉植入部位的情况下，由于部位本身的形状和/或在植入部位可能存在的钙沉积物的大小，环形部分6的变形模式可以在很大程度上变化，而由于相关位置(Valsalva窦和升主动脉)的状况变化较小，相反，拱形支柱8的变形模式可以是合理地可预测且规则的。因此，支撑柱18可受益于其所附接的防护件的各部分的高度可预测且合理地规则变形，从而保持其相对位置并允许具有瓣膜小叶4的人工瓣膜尽可能有效地操作，并且最终独立于植入部位的形状和条件。
另外，由于防护件设计，避免了假体的折叠现象。通常由于锚固结构16向内旋转而发生折叠，其中一个顺时针旋转，而另一个逆时针旋转以共同导致环形部分6向内移位。桥接两个结构部分的锚固结构16具有相当大的轴向延伸和/或抗弯曲性(相对于锚固结构而言)，这可能不希望地促进这些现象，因为锚固结构最终会容纳防护件2内的大部分变形，上面的结构部分(例如，防护件相对端的两个环形部分)固有地无法容纳这种变形。
因为防护件2具有拱形支柱8的图案，所以锚固结构16基本上桥接一个结构部分，例如环形部分6，该结构部分具有相对于结构16的相当大的轴向延伸和/或抗弯曲性，而另一结构部分诸如拱形支柱8主要在其近侧部分(即，近端10和支柱间部分22)受到结合结构约束，而远端12处的远侧部分20则相对自由以容纳从防护件的近侧(较硬的)部分)穿过防护件的变形(例如流入)。拱形支柱8所经受的结构约束的强度或压合量的这种差异允许将结构动作从锚固结构转移开，否则该结构作用将倾向于使锚固结构16旋转。转移可例如在拱形支柱的整个长度上和/或其朝向其远端12发生。
换句话说，拱形支柱趋于补偿(实质上是因为它们对防护件的其余部分具有较小程度的约束)在锚固结构16上的扭转力，从而保持它们彼此分离和作为整体的防护件2尽可能接近预期形状。
自然地，尽管本公开的思想和原理保持相同，但是在不脱离本公开的范围的情况下，构造和实施例的细节可以相对于通过实例描述和示出的内容而广泛地变化。
在不脱离本公开的范围的情况下，可对所论述的实例性实施例进行各种修改和添加。举例来说，尽管上述实施例涉及特定特征，但本公开的范围还包括具有特征的不同组合的实施例以及不包括所述特征中的所有的实施例。因此，本公开的范围旨在涵盖落入权利要求的范围内的所有这类替代、修改和变化及其所有等同形式。

Claims (20)

1.一种心脏瓣膜假体(1)，包括：
用于将瓣膜假体(1)锚固在植入部位的防护件(2)，所述防护件(2)限定了供血流通过的内腔，并具有纵轴线(X1)；和
一组人工瓣膜小叶(4)，其由所述防护件(2)支撑并构造成在径向展开的状态下在血液流动的作用下移动以使血液能够沿第一方向流动通过所述内腔，以及在径向收缩的状态下移动，其中所述瓣膜小叶(4)相互配合并沿与所述第一方向相反的方向阻止血液流动通过假体(1)，
防护件(2)包括：
环形部分(6)
由所述环形部分(6)承载的拱形支柱(8)的图案，所述拱形支柱(8)的图案具有连接到所述环形部分的近端(10)以及与所述近端(10)轴向相隔且与所述环形部分(6)相对的远端(12)，
多个组(14)的锚固结构(16)，其构造成从所述环形部分(6)径向向外突出，每组(14)由所述环形部分(6)和相应的拱形支柱(8)中的至少一个支撑，和
多个支撑柱(18)，每个支撑柱(18)由相邻的拱形支柱(8)支撑，
其中锚定结构(16)的所述组(14)与支撑柱(8)围绕所述纵轴线(8)交替。
2.根据权利要求1所述的心脏瓣膜假体(1)，其中每组(14)的锚固结构(16)在对应的拱形支柱(8)和所述环形部分(6)之间以桥状延伸。
3.根据权利要求1或权利要求2所述的心脏瓣膜假体(1)，其中每个支撑柱(18)悬臂(24、26)到相邻的拱形支柱(8)。
4.根据前述权利要求中任一项所述的心脏瓣膜假体(1)，其中每个拱形支柱(8)从第一近端(10)延伸到远端(12)，然后延伸到第二近端(10)。
5.根据权利要求4所述的心脏瓣膜假体(1)，其中每组(14)的锚固结构(16)从拱形支柱(8)以桥状延伸至包括在两个近端(10)之间的所述环形部分(6)的一部分。
6.根据权利要求5所述的心脏瓣膜假体(1)，其中每组(14)的锚固结构(16)包括两个锚固结构(16)。
7.根据权利要求5或权利要求6所述的心脏瓣膜假体(1)，其中每个锚固结构(16)包括蛇形、编织或带孔的图案。
8.根据权利要求4所述的心脏瓣膜假体(1)，其中每个支撑柱在支柱间位置处成角度地布置在两个相邻的拱形支柱之间，所述支柱间位置(22)对应于在所述两个相邻的拱形支柱(8)之间共享的近端(10)的位置。
9.根据权利要求3或权利要求8所述的心脏瓣膜假体(1)，其中所述支撑柱(18)通过在支撑柱(18)处合并的第一和第二悬臂支柱(24、26)而悬臂至所述一对拱形支柱(8)。
10.根据前述权利要求中任一项所述的心脏瓣膜假体(1)，其中所述环形部分(6)由套带(SC)覆盖以在植入部位提供密封，所述套带(SC)布置在防护件(2)的内腔的外部。
11.根据权利要求10所述的心脏瓣膜假体(1)，其中所述套带(SC)与所述一组人工瓣膜小叶(4)分开。
12.根据前述权利要求中任一项所述的心脏瓣膜假体(1)，其中所述环形部分(6)包括构造为被瓣膜加载或卷曲设施或器械接合的一个或多个联接元件。
13.根据前述权利要求中任一项所述的心脏瓣膜假体(1)，其中所述一组人工瓣膜小叶(4)限定了人工主动脉瓣，所述心脏瓣膜假体是主动脉瓣假体。
14.根据权利要求1所述的心脏瓣膜假体(1)，其中每个拱形支柱(8)在其远端(12)处包括远侧部分(20)，该远侧部分是大致C形的，并且构造成与输送器械的瓣膜保持器或载体部分配合。
15.根据权利要求1或权利要求14所述的心脏瓣膜假体(1)，其中拱形支柱(8)的图案包括布置在所述近端处的支柱间部分22，并且所述环形部分具有包括单元和节点的网格结构，所述支柱间部分(22)具有延伸穿过所述环形部分(6)的网格的节点的Y形或U形。
16.一种心脏瓣膜假体(1)，包括：
用于植入部位的瓣膜假体(1)的防护件(2)，
由所述防护件(2)支撑的一组人工瓣膜小叶(4)，
所述防护件(2)包括：
环形部分(6)
连接到所述环形部分(6)的多个拱形支柱(8)，
由相邻的拱形支柱(8)支撑的多个支撑柱(18)，每个具有自由近端和远侧部分。
17.根据权利要求16所述的心脏瓣膜假体(1)，其还包括多个组(14)的锚定结构(16)，其构造成从所述环形部分(6)径向向外突出，每组(14)由所述环形部分(6)和相应的拱形支柱(8)中的至少一个支撑。
18.根据权利要求16所述的心脏瓣膜假体，其中所述支撑柱(18)悬臂至相邻的拱形支柱(8)。
19.根据权利要求17所述的心瓣膜假体，其中每组(14)的锚固结构(16)在对应的拱形支柱(8)和所述环形部分(6)之间以桥状延伸。
20.根据权利要求17所述的心脏瓣膜假体(1)，其中锚固结构(16)的所述组(14)围绕所述假体(1)的纵轴线(8)与所述支撑柱(8)交替。
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