CN111050701B - 用于人工心脏瓣膜的密封构件 - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- 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
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- 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
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- 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
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- 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
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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
- 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
- A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- 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
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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- 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
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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Abstract
一种人工心脏瓣膜,可以包括框架、瓣膜部件以及密封构件。框架可以具有流入端部、流出端部、设置在流入端部与流出端部之间的中间部分以及多个支柱。框架可以在径向压缩构造与径向扩张构造之间可径向压缩和扩张。瓣膜部件可以设置在框架内并联接到框架,并且具有多个小叶。密封构件可以具有多个肋和多个垂帘。当框架处于径向扩张构造时,肋可以联接到框架并从其径向向外延伸。垂帘可以联接到框架和肋并在其之间径向延伸。密封构件可以经配置成减少或防止人工心脏瓣膜周围的瓣周漏。
Description
技术领域
本公开涉及可植入的、可扩张的假体装置以及用于这种假体装置的方法和设备。
背景技术
人类心脏可能患有各种瓣膜疾病。这些瓣膜疾病会导致心脏的严重功能障碍,并且最终需要用人工瓣膜替代天然瓣膜。存在许多已知的人工瓣膜和将这些人工瓣膜植入人体内的许多已知方法。由于常规的心内直视手术的缺点,经皮和微创手术方法正受到广泛关注。在一种技术中,人工心脏瓣膜经配置成通过导管插入术以侵入性小得多的方式植入。例如,可收缩的经导管人工心脏瓣膜可以被压缩,并且在压缩状态下在输送设备中经皮引入并在所需位置扩张至功能尺寸。经导管人工心脏瓣膜的挑战是控制瓣膜周围的瓣周漏,该瓣周漏可能在初始植入后一段时间内发生。
发明内容
本文公开了具有密封构件的人工心脏瓣膜的示例性实施例。密封构件可以例如减少和/或消除瓣周漏。
在一个代表性实施例中,人工心脏瓣膜可以包括框架、瓣膜部件和密封构件。
在一些实施例中,框架可以具有流入端部、流出端部、设置在流入端部与流出端部之间的中间部分以及多个支柱。框架可以在径向压缩构造与径向扩张构造之间径向压缩和扩张。
在一些实施例中,瓣膜部件可以设置在框架内并联接到框架,并且具有多个小叶。
在一些实施例中,密封构件可以具有多个肋和多个垂帘。当框架处于径向扩张构造时,肋可以联接到框架并从其径向向外延伸。垂帘可以联接到框架和肋并在其之间径向延伸。密封构件可以经配置成减少或防止人工心脏瓣膜周围的瓣周漏。
在另一个代表性实施例中,人工心脏瓣膜可以包括框架、瓣膜部件和密封构件。密封构件可以包括多个肋、多个第一垂帘以及多个第二垂帘。当框架处于径向扩张构造时,肋可以联接到框架并从其径向向外延伸。第一垂帘可以联接到框架和肋,与肋周向对齐,并在框架与肋之间径向延伸。第二垂帘可以联接到框架、肋和第一垂帘。
在又一个代表性实施例中,人工心脏瓣膜可以包括框架、瓣膜部件以及密封构件。密封构件可以包括多个肋、多个垂帘以及一个或多个绳。当框架处于径向扩张构造时,肋可以联接到框架并从其径向向外延伸。垂帘可以联接到框架和肋并在其之间径向延伸。绳可以联接到框架和肋,以便限制肋相对于框架的径向扩张。密封构件可以经配置成减少或防止人工心脏瓣膜周围的瓣周漏。
本公开的各种创新可以组合或单独使用。提供本概述以简化形式介绍概念的选择,这些概念在下面的详细描述中进一步描述。本概述不旨在标识要求保护的主题的关键特征或必要特征,也不旨在用于限制要求保护的主题的范围。从本公开的其他部分(包括具体实施方式、附图、权利要求书和摘要),本公开的前述和其他目的、特征和优点将变得更加明显。
附图说明
图1描绘了根据一个实施例的具有密封构件的人工心脏瓣膜。
图2描绘了处于径向扩张构造的图1的人工心脏瓣膜的框架和密封构件(仅部分地示出)。
图3描绘了处于径向压缩构造的图1的人工心脏瓣膜的框架和密封构件(仅部分地示出)。
图4描绘了图1的人工心脏瓣膜的密封构件的细节。
图5描绘了植入心脏的天然主动脉瓣中的图1的人工心脏瓣膜(以部分剖视图示出)。
图6描绘了根据另一实施例的具有密封构件的图1的人工心脏瓣膜。
图7描绘了根据又一实施例的具有密封构件的人工心脏瓣膜。
具体实施方式
总论
出于描述的目的,本文描述了本公开的实施例的某些方面、优点和新颖特征。公开的方法、设备和系统不应被解释为以任何方式进行限制。相反,本公开单独地以及以彼此的各种组合和子组合针对各种公开的实施例的所有新颖和非显而易见的特征和方面。方法、设备和系统不限于任何特定的方面或特征或其组合,公开的实施例也不要求存在任何一个或多个特定的优点或解决问题
虽然为了方便呈现,以特定的顺序描述了一些公开的实施例的操作,但是应理解,这种描述方式包括重新排列,除非下面阐述的特定语言要求特定的顺序。例如,顺序描述的操作在某些情况下可以被重新安排或同时执行。此外,为了简单起见,附图可能未示出可以将公开的方法与其他方法结合使用的各种方式。另外,该描述有时使用诸如“提供(provide)”或“实现(achieve)”之类的术语来描述公开的方法。这些术语是对执行的实际操作的高级抽象。对应于这些术语的实际操作可以根据特定的实施方式而变化,并且可以由本领域的普通技术人员容易地辨别。
如在本申请和权利要求书中所使用的,单数形式“一(a)”、“一个(an)”和“该(the)”包括复数形式,除非上下文另有明确规定。另外,术语“包括(includes)”是指“包含(comprises)”。此外,术语“联接(coupled)”通常是指物理地、机械地、化学地、磁性地和/或电耦合或链接,并且不排除在缺少特定相反语言的联接或关联项目之间存在中间元件。
如本文所使用的,术语“近端(proximal)”是指更靠近使用者且更远离植入部位的装置的位置、方向或一部分。如本文所使用的,术语“远端(distal)”是指远离使用者且更靠近植入部位的装置的位置、方向或一部分。因此,例如,装置的近端运动是装置远离植入部位且朝向使用者(例如,离开患者的身体)的运动,而装置的远端运动是装置远离使用者且朝向植入部位(例如,进入患者的身体)的运动。术语“纵向(longitudinal)”和“轴向(axial)”是指沿近端和远端方向延伸的轴线,除非另有明确定义。
如本文所使用的,术语“整体形成(integrally formed)”和“一体式结构(unitaryconstruction)”是指不包括任何焊接、紧固件或用于将单独形成的材料件彼此固定的其他装置的结构。
如本文所使用的,术语“大约(approximately)”是指所列值和所列值的10%以内的任何值。例如,“大约100度”是指90-110度之间的任何角度,包括90-110度。
示例性实施例
本文公开了具有密封构件的人工心脏瓣膜的示例性实施例。密封构件可以例如减少和/或消除瓣周漏(“PVL”)。
在一些实施例中,密封构件可以包括从人工心脏瓣膜的框架径向向外延伸的一个或多个肋。在某些实施例中,密封构件还包括在肋与框架之间径向延伸的一个或多个垂帘。
在特定实施例中,肋和/或垂帘是柔性的,使得密封构件可以适应天然心脏瓣膜环的解剖结构。以这种方式,密封构件可以减少和/或消除人工心脏瓣膜与天然瓣膜环之间的PVL。
在一些实施例中,密封构件可以包括联接到人工心脏瓣膜的肋和框架的多个绳。绳可以例如保持肋相对于框架的位置。
在一些实施例中,密封构件可以包括第一垂帘和第二垂帘。第一垂帘可以在人工心脏瓣膜的肋与框架之间径向延伸。第二垂帘可以联接到框架并从其径向向外延伸,并且可以在第一垂帘之间周向延伸。
图1-图6示出人工心脏瓣膜100及其部件的示例性实施例。参照图1,人工心脏瓣膜100可以具有四个主要部件:支架或框架102、瓣膜结构104、裙部106和瓣膜周围密封装置或密封构件108。框架102可以是环形的,并且可以经配置成支撑人工心脏瓣膜100的其他部件。瓣膜结构104可以联接到框架102并至少部分地设置在框架102内,并且可以经配置成调节通过人工心脏瓣膜100的一个方向上的血流。裙部106可以联接到框架102,并且可以设置在框架102的径向向内的表面(如图所示)和/或径向向外的表面上。裙部106可以经配置成减少和/或防止血液围绕瓣膜结构104和穿过框架102的流动。密封构件108可以联接到框架和/或裙部106并从框架和/或裙部106径向向外延伸。密封构件108可以经配置成减少和/或消除瓣膜周围的PVL。下面提供这些部件的其他详细信息。
参照图2,框架102可以具有流入端部110、流出端部112和设置在流入端部110与流出端部112之间的中间部分114。人工心脏瓣膜100可以限定延伸穿过流入端部110和流出端部112的纵轴线。
框架102可以包括以格子型图案布置的多个互连的支柱116。支柱116可以在支柱116相交的地方形成多个接合部118。设置在框架102的流入端部110和流出端部112处的支柱116的接合部118也可以被称为顶点119。支柱116被示出为相对于人工心脏瓣膜100的纵轴线对角地定位或者以一定角度偏移,并且径向地偏移。在其他实施例和/或构造中,支柱116可以比图2中所描绘的更大和/或更小程度地偏移,或者支柱116中的一些或全部可以平行于人工心脏瓣膜100的纵轴线定位(参见例如图3)。
在一些实施例中,支柱116可以可枢转地彼此联接。在所示实施例中,例如,支柱116在接合部118处形成相应的铰链。在某些实施例中,紧固件(例如,铆钉或销)120可以用于将支柱116可枢转地联接在一起。随着框架102扩张或收缩时,诸如在人工心脏瓣膜100的组装、制备和/或植入期间,铰链可以允许支柱116相对于彼此枢转。例如,框架102(并且因此人工心脏瓣膜100)可以被操纵成径向压缩或收缩的构造(例如,图3),并被插入患者体内用于植入。一旦进入患者体内,则可以将人工心脏瓣膜100操纵成扩张状态(例如,图1-图2),如下文进一步描述的。
可以使用任何合适的技术来形成框架102。合适的技术可以包括单独形成框架102的各个部件(例如,支柱116和紧固件120),并且然后机械地组装和连接各个部件以形成框架102。支柱116和紧固件120可以例如通过从金属片或金属管激光切割那些部件或者通过电铸(电镀或电沉积)或物理气相沉积来形成。在一些实施例中,电铸或物理气相沉积可以用于形成框架102的子部件或整个框架102,其中在支柱116之间具有可枢转的连接。在一个实施例中,例如,电铸或物理气相沉积可以用于形成具有整体紧固件120的支柱116。通过将每个支柱的整体紧固件120插入通过相邻支柱的对应孔,可以将各个支柱116组装在一起成框架。在一些实施例中,电铸或物理气相沉积可以用于形成处于其最终圆柱形的整个框架102。在其他实施例中,电铸或物理气相沉积可以用于形成扁平构造的整个框架,之后将扁平框架的端部彼此连接以形成框架的最终圆柱形状。
在其他实施例中,支柱116不通过各自的铰链(例如,紧固件)彼此联接,而是相对于彼此可枢转或可弯曲以允许框架的径向扩张和收缩。例如,框架102可以由单件材料(例如,金属管)形成(例如,通过激光切割、电铸或物理气相沉积)。
框架102可以由各种合适的材料中的任一种制成,诸如不锈钢或镍钛合金(“NiTi”),例如镍钛诺。
关于框架102的其他细节可以在例如2016年12月6日提交的美国申请No.62/430,810和美国专利申请公开No.2018/0153689中找到。
返回到图1,瓣膜结构104可以调节通过人工心脏瓣膜100的血流。瓣膜结构104可以包括例如小叶组件122,该小叶组件122包括由柔性材料制成的一个或多个小叶。小叶组件122的小叶可以全部或部分地由生物材料(例如,心包组织,诸如牛、猪或马的心包)、生物相容的合成材料和/或其他此类材料(包括在美国专利No.6,730,118中描述的那些材料)制成。关于经导管人工心脏瓣膜的进一步细节(包括可以将瓣膜结构104联接到人工心脏瓣膜100的框架102的方式)可以在例如美国专利No.7,393,360、No.7,510,575、No.7,993,394和No.8,652,202中找到。
如上所述,裙部106可以安装在框架102的内部和/或外部。裙部可以由天然组织(例如,心包组织)或各种生物相容的合成材料(包括生物相容的织物(例如,聚对苯二甲酸乙二醇酯(“PET”)织物))中的任一种形成。关于裙部106以及瓣膜结构104的其他细节可以在例如美国专利No.9,974,650中找到。
密封构件108可以形成当人工心脏瓣膜处于径向扩张构造时从人工心脏瓣膜100的框架102径向向外延伸的柔性结构。这样,密封构件108可以例如适应天然瓣环的解剖结构,并限制或阻止人工心脏瓣膜100周围的血液流动,从而消除或减少PVL。
密封构件108可以包括多个肋124和多个垂帘126,它们也可以被称为“连接器”。如图2所示,肋124联接到框架102并从框架102径向向外延伸。如图4所示,垂帘126联接到框架102和肋124并在框架102与肋124之间径向延伸。以这种方式,肋124充当垂帘126的支撑结构,并且垂帘126阻塞了框架102与肋124之间的间隙。在一些实施例中,每个垂帘126可以具有连接到裙部106的内部纵向延伸边缘140和连接到肋124的外部纵向延伸边缘142。
肋124可以以各种方式联接到框架102。例如,肋124和框架102可以通过焊接、紧固件(例如,铆钉、销、螺钉)、缝合线、粘合剂和/或其他合适的联接手段进行联接。
再次参考图2,肋124可以具有第一端部128(如图2所示的下端部)和第二端部130(如图2所示的上端部)。在一些实施例中,第一端部128可以联接到框架102的流入端部110,并且第二端部130可以联接到框架102的中间部分114。在其他实施例中,第一端部128和/或第二端部130可以联接到框架102的各种其他部分(例如,流出端部112)。
在某些实施例中,肋124的第一端部128和第二端部130可以联接到框架102的相应接合部118。例如,在所示实施例中,第一端部128联接到周向第一排接合部(即,从流入端部110开始计数),并且第二端部130联接到周向第四排接合部。在其他实施例中,第一端部128和/或第二端部130可以联接到各种其他排的接合部。
在特定实施例中,每个肋124的第一端部128可以相对于相应的第二端部130周向偏移,使得当人工心脏瓣膜100处于径向扩张构造时,肋124相对于人工心脏瓣膜100的纵轴线成角度。在一些实施例中,相邻的肋124的第一端部128可以在框架上的相同位置处或附近联接到框架102,并且相邻的肋124的第二端部130可以在框架上的相同位置处或附近联接到框架102。这样,当人工心脏瓣膜100处于径向扩张构造时(例如,图1),肋124可以例如形成之字形或波浪形图案。
肋124的第一端部128和第二端部130可以在如下位置处联接到框架102,即随着人工心脏瓣膜在径向扩张/轴向缩短构造和径向压缩/轴向伸长构造之间移动,位置之间的相对距离发生变化。
肋124被设定尺寸和配置成使得,当人工心脏瓣膜100处于径向扩张构造时(例如,图1),肋124在其相反端之间的长度长于第一端部128和第二端部130附接到框架102的位置之间的直线距离。因此,肋124可以在径向扩张构造中从框架102径向向外张开。
肋124还被设定尺寸和配置成使得,当人工心脏瓣膜100处于径向压缩构造时(例如,图3),肋124的长度等于或近似等于第一端部128和第二端部130附接到框架102的位置之间的距离。因此,肋124可以在径向压缩构造中抵靠框架102径向设置。如图所示,在特定实施例中,肋124可以经配置成使得肋124在径向压缩构造中具有“S”形。
肋124的长度和/或肋124附接到框架102的位置被设定尺寸和/或配置成调节肋124相对于框架102径向扩张的程度。例如,具有相对较长长度的肋可以比具有相对较短长度的肋径向向外扩张得更远(假设它们相对于人工心脏瓣膜100的纵轴线在相同位置处附接到框架)。
在一些实施例中,肋124可以相对于框架102设定尺寸和/或定位,使得每个肋可以从框架102径向等距地扩张。这可以例如通过形成具有相同长度的每个肋124并相对于框架的纵轴线在相同位置处将肋联接到框架102来实现。这也可以例如通过形成长度不同于至少一个其他肋的一个或多个肋124并以第一端部128和第二端部130之间的间隔不同于至少一个其他肋的方式将一个或多个肋联接到框架来实现。
在其他实施例中,一个或多个肋124可以相对于框架102设定尺寸和/或定位成使得一个或多个肋可以比至少一个其他肋相对更多或更少地径向扩张。这可以例如通过形成长度不同于至少一个其他肋的一个或多个肋124并以第一端部128和第二端部130之间的间隔不同于至少一个其他肋的方式将一个或多个肋联接到框架来实现。
肋124可以由弹性材料形成,使得当肋随着人工心脏瓣膜100在径向扩张构造和径向压缩构造之间移动而压缩和扩张时,肋124趋向于不塑性变形。这可以例如通过由相对柔性的材料诸如镍钛诺、不锈钢或合适的生物相容聚合物形成肋来实现。
虽然为了说明的目的,垂帘126以网状图案示出,但是垂帘可以包括紧密编织的或片状的材料。在一些实施例中,垂帘126可以包括经配置成阻塞或限制血液流动的柔性织物或材料,包括PET、聚四氟乙烯(“PTFE”)、膨体聚四氟乙烯(“ePTFE”)、聚氨酯和/或聚酯。在某些实施例中,垂帘126可以由与裙部106相同的材料(例如,PET)形成。在其他实施例中,垂帘126和裙部106可以由不同的材料形成。例如,垂帘126可以由PTFE形成且裙部106可以由聚酯形成,或者反之亦然。
垂帘126可以以各种方式联接到肋124和/或裙部106。例如,在一些实施例中,每个垂帘126可以缠绕在相应的肋124上并与其自身联接(例如,通过紧固件、缝合线、粘合剂、超声波焊接和/或其他合适的联接手段)。在其他实施例中,垂帘126可以联接到肋124,而无需将垂帘缠绕在肋上。垂帘126可以例如通过紧固件、缝合线、粘合剂、超声波焊接和/或其他合适的联接手段联接到裙部106。在一个示例中,每个垂帘126的边缘140可以沿着边缘140的整个长度(例如使用平伏针迹)缝合到裙部106。
垂帘126被设定尺寸和/或配置成使得当人工心脏瓣膜100从径向扩张构造压缩至径向压缩构造时,垂帘松弛和/或折叠。这允许肋124抵靠框架102径向向内压缩,从而减小了处于径向压缩构造的人工心脏瓣膜的径向轮廓。垂帘126被设定尺寸和/或配置成使得当人工心脏瓣膜100从径向压缩构造扩张至径向扩张构造时,垂帘收紧和/或展开。
可选地,密封构件108还可以包括多个保持构件或绳132。绳132可以联接到框架102并从框架102延伸到肋124。绳132可以例如经配置成相对于框架102以期望的间隔和/或构造保持肋124。
绳132可以例如在肋的第一端部128和第二端部130之间的位置处联接到框架102和肋124。例如,在一些实施例中,绳132可以联接到框架102的被设置在肋124的第一端部128和第二端部130附接到的接合部之间的接合部118并由此延伸。
在一些实施例中,每个肋124具有与其联接的两个绳132。在其他实施例中,每个肋124可以具有与其联接的多于或少于两个的绳132。在一些实施例中,可以存在联接到(例如,缠绕)所有肋124和框架102的单个绳。
绳132可以由相对柔性的非弹性材料诸如尼龙线或不锈钢线形成。以这种方式,当人工心脏瓣膜100从径向扩张构造压褶到径向压缩构造时,绳132可以松弛和/或折叠,并且当人工心脏瓣膜从径向压缩构造扩张至径向扩张构造时,绳可以收紧和/或展开。
绳132的长度被设定尺寸和/或配置成控制肋124可相对于框架102径向扩张的程度。例如,与具有相对较长长度的绳相比,具有相对较短长度的绳132可以保持肋124径向更靠近框架102。在一些实施例中,绳132可以相对于肋124设定尺寸和/或定位成使得每个肋可以从框架102径向等距地扩张。在其他实施例中,绳132中的一个或多个可以相对于肋124设定尺寸和/或定位成使得肋中的一个或多个可以比至少一个其他肋相对或多或少地扩张。
绳132的长度还被设定尺寸和/或配置成控制肋124的径向扩张构造(例如,形状)。例如,在一个特定实施例中,在相对的圆周方向上延伸的两个轴向间隔的绳132可以在肋124的第一端部128和第二端部130之间联接到每个肋124。当肋处于径向扩张构造时,绳132可以均具有比框架102上绳132所附接的点与肋124之间的直线距离小的长度。这样,当肋处于径向扩张构造时,绳132可以使肋124具有“S”形。
每个绳132附接到肋124的位置可以经配置成调节肋124的形状(例如,弧形)。在一些实施例中,每个绳132附接到肋124的位置可以经配置成使得当人工心脏瓣膜100处于径向扩张构造时每个肋的形状是相同的。在其他实施例中,一个或多个绳132附接到肋124的位置可以经配置成使得当人工心脏瓣膜100处于径向扩张构造时所述一个或多个肋的形状不同于至少一个其他肋。
代替绳132或除了绳132之外,肋124可以被形状设定为期望的构造。在此类实施例中,肋124可以由形状记忆材料例如镍钛诺形成。
人工心脏瓣膜100可以可释放地联接到输送设备,并压褶成径向压缩构造。虽然未示出,但是人工心脏瓣膜100可以包括致动机构,该致动机构联接到人工心脏瓣膜100的框架102,并且与输送设备协作地配置成使人工心脏瓣膜在径向压缩构造和径向扩张构造之间递增地移动。关于致动机构和输送设备的其他细节可以例如在美国申请No.62/430,810和美国专利申请公开No.2018/0153689中找到。
在径向压缩构造中,人工心脏瓣膜100可以经皮前进到患者的心脏并定位在天然瓣膜环中。人工心脏瓣膜100可以从径向压缩构造扩张至径向扩张构造。
在径向扩张构造中,密封构件108可以接合邻近人工心脏瓣膜100的天然瓣环的组织,并填充可能存在于人工心脏瓣膜100的框架102与天然瓣环之间的任何间隙。以这种方式,密封构件108可以例如减少和/或防止血液在框架102与天然瓣环之间围绕人工心脏瓣膜100流动。
例如,图5示出处于径向扩张构造并设置在心脏202的天然主动脉瓣膜200内的人工心脏瓣膜100(以部分剖视图示出)。如图所示,密封构件108可以接合邻近人工心脏瓣膜100的天然瓣环和/或小叶的组织,并阻塞其间可能存在的任何间隙。因此,密封构件减少和/或防止血液在左心室204与主动脉206之间围绕人工心脏瓣膜100流动。
人工心脏瓣膜100可以固定在天然瓣环内并从输送设备释放。在人工心脏瓣膜100被释放之后,密封构件108可以继续减少和/或防止PVL。
图6示出代替密封构件108联接到人工心脏瓣膜100的密封构件300的示例性实施例。密封构件300可以包括多个肋302和多个第一垂帘304。密封构件300还可以可选地包括多个绳306和/或多个第二垂帘308。
肋302、第一垂帘304和绳306可以例如分别经配置成类似于人工心脏瓣膜100的肋124、垂帘126和绳132。
第二垂帘308可以联接到相邻成对的肋302并在其之间周向延伸。第二垂帘308也可以联接成从裙部106径向向外延伸。以这种方式,第二垂帘308可以例如提供除第一垂帘304之外的用于减少和/或消除PVL的附加和/或替代手段。
在密封构件300包括绳306的实施例中,第二垂帘308可以在由绳306限定的平面中延伸。在其他此类实施例或密封构件300不包括绳306的实施例中,第二垂帘308可以在各种其他平面中延伸。
在特定实施例中,第二垂帘308可以在至少与垂直于人工心脏瓣膜100的纵轴线的平面近似平行的平面中从裙部106延伸。在其他实施例中,第二垂帘308可以在相对于与人工心脏瓣膜100的纵轴线垂直的平面成角度的平面中从裙部106延伸。例如,在一些实施例中,第二垂帘308可以限定相对于与人工心脏瓣膜100的纵轴线垂直的平面成大约10-80度角的平面。在特定实施例中,第二垂帘308可以限定相对于与人工心脏瓣膜100的纵轴线垂直的平面成大约25-65度或大约45度角的平面。
第二垂帘308可以以各种方式联接到肋302和/或裙部106。例如,垂帘126可以通过紧固件、缝合线、粘合剂、超声波焊接和/或其他合适的联接手段联接到肋302和裙部106。
第二垂帘308可以包括经配置成阻塞或限制血液流动的柔性织物或材料,包括PET、PTFE、ePTFE、聚氨酯和/或聚酯。在一些实施例中,第二垂帘308可以由与第一垂帘304和/或裙部106相同的材料(例如,PET)形成。在其他实施例中,第一垂帘304、第二垂帘308和裙部106中的至少一个可以由不同的材料形成。例如,第二垂帘308可以由PTFE形成且裙部106可以由聚酯形成,或者反之亦然。
图7示出示例性人工心脏瓣膜400。人工心脏瓣膜400可以包括框架402、瓣膜结构404、裙部406和密封构件408。人工心脏瓣膜400可以被设计成类似于人工心脏瓣膜100,除了人工心脏瓣膜400的框架402是可自扩张和/或球囊扩张的,而不像人工心脏瓣膜100的框架102那样是机械扩张的。关于框架402、瓣膜结构404和裙部406的其他细节可以在例如美国专利No.9,974,650中找到。
在一些实施例中,密封构件408可以经配置成类似于人工心脏瓣膜100的密封构件108。密封构件408可以包括联接到框架402的肋410和在裙部406与肋410之间径向向外延伸的垂帘412。
在某些实施例中,密封构件408可以包括联接到肋410和框架402并在其之间延伸的绳。例如,绳可以经配置成类似于密封构件300的绳306。
在特定实施例中,密封构件408的垂帘412可以是第一垂帘,并且密封构件还可以包括第二垂帘。例如,密封构件408的第一垂帘和第二垂帘可以分别经配置成类似于密封构件300的第一垂帘304和第二垂帘308。
下面列举了所公开技术的其他示例。
1.一种人工心脏瓣膜,包括:
框架,具有流入端部、流出端部、设置在流入端部与流出端部之间的中间部分以及多个支柱,其中框架在径向压缩构造与径向扩张构造之间可径向压缩和扩张;
瓣膜部件,设置在框架内并联接到框架,并且具有多个小叶;以及
密封构件,具有多个肋和多个垂帘,其中当框架处于径向扩张构造时肋联接到框架并从其径向向外延伸,其中垂帘联接到框架和肋并在其之间径向延伸,并且其中密封构件经配置成减少或防止人工心脏瓣膜周围的瓣周漏。
2.根据示例1所述的人工心脏瓣膜,其中肋中的每个包括连接到框架的流入端部的第一端部和连接到框架的中间部分的第二端部。
3.根据示例2所述的人工心脏瓣膜,其中框架的支柱形成成排的接合部,在此支柱彼此连接,并且其中肋的第一端部连接到一排接合部,肋的第二端部连接到与所述一排接合部间隔开的另一排接合部。
4.根据示例2或3所述的人工心脏瓣膜,其中当人工心脏瓣膜处于径向扩张构造时,每个肋的第一端部相对于肋的第二端部周向偏移。
5.根据示例2至4中任一项所述的人工心脏瓣膜,其中相邻肋的第一端部联接到框架的第一顶点,并且相邻肋的第二端部联接到框架的第二顶点。
6.根据示例1至5中任一项所述的人工心脏瓣膜,其中密封构件的肋以围绕框架周向延伸的之字形或波浪形图案联接在一起。
7.根据示例1至6中任一项所述的人工心脏瓣膜,还包括连接到框架和密封构件的肋并在其之间延伸的多个柔性绳。
8.根据示例7所述的人工心脏瓣膜,其中绳在被设置在肋的第一端部与第二端部之间的肋的中间部分处连接到肋。
9.根据示例1至8中任一项所述的人工心脏瓣膜,还包括安装在框架上的裙部,并且其中垂帘具有缝合到裙部的内部纵向延伸边缘和固定到肋的外部纵向延伸边缘。
10.根据示例1至9中任一项所述的人工心脏瓣膜,其中密封构件的垂帘是第一垂帘,其中密封构件还包括多个第二垂帘,多个第二垂帘联接到框架和肋,并且周向设置在相邻的肋与第一垂帘之间。
11.根据示例1至9中任一项所述的人工心脏瓣膜,其中肋和垂帘沿框架纵向延伸。
12.根据示例1至11中任一项所述的人工心脏瓣膜,其中垂帘包括PET、PTFE、ePTFE、聚氨酯或聚酯。
13.根据示例1至12中任一项所述的人工心脏瓣膜,其中框架从径向压缩构造可至少部分地自扩张至径向扩张构造。
14.根据示例1至12中任一项所述的人工心脏瓣膜,其中框架从径向压缩构造可至少部分机械地扩张至径向扩张构造。
15.一种人工心脏瓣膜,包括:
框架,具有流入端部、流出端部、设置在流入端部与流出端部之间的中间部分以及多个支柱,其中框架在径向压缩构造与径向扩张构造之间可径向收缩和扩张;
瓣膜部件,设置在框架内并联接到框架,并且具有多个小叶;以及
密封构件,具有多个肋、多个第一垂帘以及多个第二垂帘,其中当框架处于径向扩张构造时肋联接到框架并从其径向向外延伸,其中第一垂帘联接到框架和肋、与肋周向对齐并在框架与肋之间径向延伸,并且其中第二垂帘联接到框架、肋和第一垂帘。
16.根据示例15所述的人工心脏瓣膜,其中第一垂帘中的每个连接到相应的肋,并且其中第二垂帘中的每个在相邻的肋之间周向延伸。
17.根据示例15或16所述的人工心脏瓣膜,其中肋和第一垂帘沿框架纵向延伸。
18.根据示例15至17中任一项所述的人工心脏瓣膜,其中第一垂帘在第一平面中从框架延伸,并且其中第二垂帘在至少基本上垂直于第一平面的第二平面中从框架延伸。
19.根据示例15至18中任一项所述的人工心脏瓣膜,还包括联接到框架和肋并在其之间延伸的多个柔性绳,并且其中第二垂帘安装到绳。
20.一种人工心脏瓣膜,包括:
框架,具有流入端部、流出端部、设置在流入端部与流出端部之间的中间部分以及多个支柱,其中框架在径向压缩构造与径向扩张构造之间可径向压缩和扩张;
瓣膜部件,设置在框架内并联接到框架,并且具有多个小叶;以及
密封构件,具有多个肋、多个垂帘以及一个或多个绳,其中当框架处于径向扩张构造时肋联接到框架并从其径向向外延伸,其中垂帘联接到框架和肋并在其之间径向延伸,其中绳联接到框架和肋,以便限制肋相对于框架的径向扩张,并且其中密封构件经配置成减少或防止人工心脏瓣膜周围的瓣周漏。
除非另有说明,否则本文关于任何示例描述的特征可以与在任何一个或多个其他示例中描述的其他特征相结合。例如,密封构件108的特征可以与密封构件300和/或密封构件408结合,或者反之亦然。另外,除非另有说明,否则实施例的任何特征都独立于实施例的其他部件。
鉴于可以应用本公开的原理的许多可能的实施例,应当认识到,所示实施例仅是示例,不应被视为限制所要求保护的主题的范围。相反,所要求保护的主题的范围由以下权利要求书及其等同物来限定。
Claims (21)
1.一种人工心脏瓣膜,包括:
框架,具有流入端部、流出端部、设置在所述流入端部与流出端部之间的中间部分以及多个支柱,其中所述框架在径向压缩构造与径向扩张构造之间可径向压缩和扩张;
瓣膜部件,设置在所述框架内并联接到所述框架,并且具有多个小叶;以及
密封构件,具有多个肋和多个垂帘,其中当所述框架处于所述径向扩张构造时所述肋联接到所述框架并从所述框架径向向外延伸,其中所述垂帘联接到所述框架和所述肋并在所述框架与所述肋之间径向延伸,并且其中所述密封构件经配置成减少或防止所述人工心脏瓣膜周围的瓣周漏。
2.根据权利要求1所述的人工心脏瓣膜,其中每个所述肋包括连接到所述框架的所述流入端部的第一端部和连接到所述框架的所述中间部分的第二端部。
3.根据权利要求2所述的人工心脏瓣膜,其中所述框架的所述支柱形成成排接合部,在此所述支柱彼此连接,并且其中所述肋的所述第一端部连接到一排接合部,所述肋的所述第二端部连接到与所述一排接合部间隔开的另一排接合部。
4.根据权利要求2或3所述的人工心脏瓣膜,其中当所述人工心脏瓣膜处于所述径向扩张构造时,每个肋的所述第一端部相对于该肋的所述第二端部周向偏移。
5.根据权利要求2或3所述的人工心脏瓣膜,其中相邻肋的所述第一端部联接到所述框架的第一顶点,并且所述相邻肋的所述第二端部联接到所述框架的第二顶点。
6.根据权利要求1至3中任一项所述的人工心脏瓣膜,其中所述密封构件的所述肋以围绕所述框架周向延伸的之字形或波浪形图案联接在一起。
7.根据权利要求2所述的人工心脏瓣膜,还包括多个柔性绳,所述多个柔性绳连接到所述框架和所述密封构件的所述肋并在所述框架与所述密封构件的所述肋之间延伸。
8.根据权利要求1或3所述的人工心脏瓣膜,还包括多个柔性绳,所述多个柔性绳连接到所述框架和所述密封构件的所述肋并在所述框架与所述密封构件的所述肋之间延伸。
9.根据权利要求7所述的人工心脏瓣膜,其中所述绳在所述肋的中间部分处连接到所述肋。
10.根据权利要求1至3中任一项所述的人工心脏瓣膜,还包括安装在所述框架上的裙部,并且其中所述垂帘具有缝合到所述裙部的内部纵向延伸边缘和固定到所述肋的外部纵向延伸边缘。
11.根据权利要求1至3中任一项所述的人工心脏瓣膜,其中所述密封构件的所述垂帘是第一垂帘,其中所述密封构件还包括多个第二垂帘,所述多个第二垂帘联接到所述框架和所述肋并且周向设置在相邻肋与所述第一垂帘之间。
12.根据权利要求1至3中任一项所述的人工心脏瓣膜,其中所述肋和所述垂帘沿所述框架纵向延伸。
13.根据权利要求1至3中任一项所述的人工心脏瓣膜,其中所述垂帘包括PET、PTFE、ePTFE、聚氨酯或聚酯。
14.根据权利要求1至3中任一项所述的人工心脏瓣膜,其中所述框架从所述径向压缩构造可至少部分地自扩张至所述径向扩张构造。
15.根据权利要求1至3中任一项所述的人工心脏瓣膜,其中所述框架从所述径向压缩构造可至少部分机械地扩张至所述径向扩张构造。
16.一种人工心脏瓣膜,包括:
框架,具有流入端部、流出端部、设置在所述流入端部与流出端部之间的中间部分以及多个支柱,其中所述框架在径向压缩构造与径向扩张构造之间可径向收缩和扩张;
瓣膜部件,设置在所述框架内并联接到所述框架并且具有多个小叶;以及
密封构件,具有多个肋、多个第一垂帘以及多个第二垂帘,其中当所述框架处于所述径向扩张构造时所述肋联接到所述框架并从所述框架径向向外延伸,其中所述第一垂帘联接到所述框架和所述肋、与所述肋周向对齐并在所述框架与所述肋之间径向延伸,并且其中所述第二垂帘联接到所述框架、所述肋和所述第一垂帘。
17.根据权利要求16所述的人工心脏瓣膜,其中每个所述第一垂帘连接到相应的肋,并且其中每个所述第二垂帘在相邻肋之间周向延伸。
18.根据权利要求16或17所述的人工心脏瓣膜,其中所述肋和所述第一垂帘沿所述框架纵向延伸。
19.根据权利要求16或17所述的人工心脏瓣膜,其中所述第一垂帘在第一平面中从所述框架延伸,并且其中所述第二垂帘在至少基本上垂直于所述第一平面的第二平面中从所述框架延伸。
20.根据权利要求16或17所述的人工心脏瓣膜,还包括联接到所述框架和所述肋并在所述框架与所述肋之间延伸的多个柔性绳,并且其中所述第二垂帘安装到所述绳。
21.一种人工心脏瓣膜,包括:
框架,具有流入端部、流出端部、设置在所述流入端部与流出端部之间的中间部分以及多个支柱,其中所述框架在径向压缩构造与径向扩张构造之间可径向压缩和扩张;
瓣膜部件,设置在所述框架内并联接到所述框架,并且具有多个小叶;以及
密封构件,具有多个肋、多个垂帘以及一个或多个绳,其中当所述框架处于所述径向扩张构造时,所述肋联接到所述框架并从所述框架径向向外延伸,其中所述垂帘联接到所述框架和所述肋并在所述框架与所述肋之间径向延伸,其中所述绳联接到所述框架和所述肋,以便限制肋相对于所述框架的径向扩张,并且其中所述密封构件经配置成减少或防止所述人工心脏瓣膜周围的瓣周漏。
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-
2018
- 2018-08-28 US US16/114,518 patent/US10973629B2/en active Active
- 2018-08-30 CN CN201880056995.XA patent/CN111050701B/zh active Active
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EP3678599A1 (en) | 2020-07-15 |
US20210228342A1 (en) | 2021-07-29 |
US10973629B2 (en) | 2021-04-13 |
KR102628810B1 (ko) | 2024-01-23 |
CN115444622A (zh) | 2022-12-09 |
WO2019050776A1 (en) | 2019-03-14 |
EP3678599A4 (en) | 2020-08-05 |
KR20200039802A (ko) | 2020-04-16 |
CA3074002A1 (en) | 2019-03-14 |
CN111050701A (zh) | 2020-04-21 |
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