CN114699220A - 可植入假体瓣膜的裙部组装件 - Google Patents
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Abstract
本申请涉及一种可植入假体瓣膜的裙部组装件。公开了可植入假体瓣膜的实施例。该瓣膜可以具有环形框架,该环形框架具有多个框架构件和裙部组装件。裙部组装件可以包括层压件,该层压件具有夹在第一覆盖构件和第二覆盖构件之间的织物层。织物层的至少一个表面可以在第二覆盖构件中的一个或多个窗口处暴露。裙部组装件可以通过缝合线耦连到环形框架,该缝合线在一个或多个窗口处并且围绕多个框架构件中的至少一个延伸穿过织物层。还公开了用于制造这种可植入假体瓣膜的方法。
Description
本申请是于2018年8月13日提交的名称为“可植入假体瓣膜的裙部组装件”的中国专利申请2018800648241(PCT/US2018/046487)的分案申请。
技术领域
本公开涉及用于植入到身体管道中的假体瓣膜的实施例,诸如原生心脏瓣膜环。
背景技术
人的心脏可能患有各种瓣膜疾病。这些瓣膜疾病可能导致严重的心脏功能失常,并且最终需要用人造瓣膜替换原生瓣膜。存在许多已知的人造瓣膜以及将这些人造瓣膜植入人体内的许多已知方法。
各种外科手术技术可以用于替换或修复患病或受损的瓣膜。由于狭窄和其他心脏瓣膜疾病,每年数千患者进行外科手术,其中有缺陷的原生心脏瓣膜被假体瓣膜替换。治疗有缺陷的瓣膜的另一种不太严重的方法是通过修复或重建,这通常用于最小钙化的瓣膜上。外科手术治疗的问题在于由于与外科手术修复相关联的高发病率和死亡率,它给这些慢性病患者带来了巨大的风险。
当替换原生瓣膜时,假体瓣膜的外科手术植入通常需要开胸外科手术,在该外科手术期间,心脏停止并且患者被置于心肺旁路上(所谓的“心肺机”)。在一种常见的外科手术程序中,切除患病的原生瓣膜小叶,并在瓣膜环处将假体瓣膜缝合到周围组织。由于与该程序相关联的创伤以及随之而来的体外血循环持续时间,一些患者无法在外科手术程序中幸存下来或不久后死亡。众所周知,患者的风险随着体外循环所需时间量的增加而增加。由于这些风险,大量的原生瓣膜有缺陷的患者被认为无法手术,因为他们的情况太虚弱以至于无法承受该程序。据一些估计,超过50%的年龄超过80岁的患有瓣膜狭窄的受试者无法进行瓣膜替换手术。
由于与常规的心脏直视手术有关的缺点,经皮和微创外科手术方法受到了广泛的关注。在一种技术中,假体瓣膜被配置为在通过导管***方式的更少侵入性程序中被植入。例如,美国专利No.5,411,522和No.6,730,118描述了可塌缩的经导管心脏瓣膜,该心脏瓣膜可以以压缩状态经皮引入导管上,并通过球囊膨胀或通过使用自扩张框架或支架而在期望位置扩张。
已知的假体瓣膜包括具有安装在其中的瓣膜结构(例如,小叶)的框架、固定到框架的内部的内裙部以及可选地包括固定到框架外部的外裙部。内裙部可以起到多种作用。例如,内裙部可以起到密封构件的作用,以防止(或减少)瓣周渗漏,将小叶锚固到框架,并且保护小叶免受在卷曲期间和在瓣膜的工作周期期间由于与框架接触而引起的损坏。外裙部可以与内裙部协作以进一步减少或避免瓣膜植入后的瓣周渗漏。内裙部理想地包括坚韧抗撕裂的材料,诸如聚对苯二甲酸乙二醇酯(PET),然而可以使用各种其他合成或天然材料。
内裙部和外裙部通常通过将相应裙部的织物缝合或缝制到框架而固定到框架。将内裙部缝合到框架可以使小叶暴露于缝合线。在瓣膜的工作周期期间,小叶和暴露的缝合线之间的反复接触以及小叶和裙部的织物材料之间的接触可能导致小叶的磨损。因此,期望对用于假体瓣膜的裙部进行改进。
发明内容
本公开涉及与诸如假体心脏瓣膜的假体瓣膜有关的方法和设备。
本公开的某些实施例涉及一种用于制造可植入假体瓣膜的方法。该方法的一个示例性实施例包括形成层压件,该层压件包括设置在第一覆盖构件和第二覆盖构件之间的织物层。第二覆盖构件可以包括一个或多个窗口,织物层在该一个或多个窗口处暴露。该方法进一步包括抵靠环形框架放置层压件,以及通过在第二覆盖构件的一个或多个窗口处并且围绕框架的一部分将缝合线穿过织物层而将层压件缝合到环形框架。
在某些实施例中,层压件可以包括环形裙部,该环形裙部的尺寸和形状被设计为覆盖框架中的开口以防止血液流过框架开口。
在某些实施例中,裙部可以被定位于环形框架的内部。
在前述实施例中,第一覆盖构件和第二覆盖构件可以通过织物层中的开口彼此熔合。
在前述实施方式中,形成层压件可以包括:通过电纺形成第一覆盖构件,在电纺的第一覆盖构件上放置织物层,以及通过电纺在织物层上形成第二覆盖构件。
在某些实施例中,形成层压件可以进一步包括:在形成第二覆盖构件之前,在织物层上掩蔽一个或多个区域,以便当在织物层上形成第二覆盖构件时,在第二覆盖构件中形成一个或多个窗口。
在某些实施例中,形成层压件可以包括:用遮蔽材料掩蔽织物层的至少一侧上的一个或多个区域,将织物层浸入液化聚合物材料中,允许液化聚合物材料固化,并且去除掩蔽材料以在层压件中形成一个或多个窗口。
在某些实施例中,第二覆盖构件中的一个或多个窗口可以在周向方向上围绕层压件连续延伸。
在某些实施例中,第一覆盖构件和第二覆盖构件包括弹性材料。
在某些实施例中,弹性材料可以包括膨胀的聚四氟乙烯(ePTFE)或超高分子量聚乙烯(UHMWPE)或聚氨酯。
本公开的某些实施例还涉及一种可植入假体瓣膜。一个代表性可植入假体瓣膜可以包括裙部组装件和具有多个框架构件的环形框架。裙部组装件可以包括层压件,该层压件具有夹在第一覆盖构件和第二覆盖构件之间的织物层。织物层可以在第二覆盖构件中的一个或多个窗口处暴露。裙部组装件可以通过缝合线耦连到环形框架,该缝合线在一个或多个窗口处并且围绕多个框架构件中的至少一个延伸穿过织物层。
在某些实施例中,裙部组装件可以被定位于环形框架的内部。
在某些实施例中,可植入假体瓣膜可以进一步包括缝合到裙部组装件的多个小叶。小叶可以被配置为允许血液在第一方向上流过假体瓣膜,并且阻止血液在与第一方向相反的第二方向上流过假体瓣膜。
在可植入假体瓣膜的前述实施例中,第一覆盖构件和第二覆盖构件可以通过织物层中的开口彼此熔合。
在可植入假体瓣膜的前述实施例中,第一覆盖构件或第二覆盖构件可以包括非织造纤维的膜。
在可植入假体瓣膜的前述实施例中,第一覆盖构件或第二覆盖构件可以是不可吸收的并且具有多孔微结构,该多孔微结构促进周围组织向内生长以帮助将假体瓣膜固定在体腔中。
在可植入假体瓣膜的前述实施例中,环形框架可以具有入口端和出口端,并且被配置为径向可塌缩和可膨胀。多个框架构件可以限定框架构件之间的多个间隙,并且裙部组装件可以被配置为防止血液流过裙部组装件覆盖的框架中的那些间隙。
在某些实施例中,裙部组装件可以仅在第二覆盖构件中的一个或多个窗口处缝合到框架。
在某些实施例中,第一覆盖构件和第二覆盖构件可以包括弹性材料。
在某些实施例中,弹性材料可以包括ePTFE或UHMWPE或聚氨酯。
本发明的前述和其他目的、特征和优点将从下面参照附图进行的详细描述中变得更加明显。
附图说明
图1示出可植入假体瓣膜的示例性实施例的侧视图。
图2示出图1的假体瓣膜的俯视透视图。
图3示出图1的假体瓣膜的示例性框架。
图4示出图3所示的框架的展平图。
图5示出沿图1的线5-5截取的图1的假体瓣膜的横截面图。
图6示出根据制造图1的假体瓣膜的内裙部的示例性工艺在芯轴上形成第一覆盖构件。
图7示出根据制造内裙部的示例性工艺在图6所示的第一覆盖构件上放置织物层。
图8示出根据制造内裙部的示例性工艺在图7所示的织物层上放置多个掩模。
图9示出根据制造内裙部的示例性工艺在具有图8所示的掩模的织物层上形成第二覆盖构件。
图10示出根据制造内裙部的示例性工艺在形成图9所示的第二覆盖构件之后去除掩模。
图11示出内裙部的一部分的横截面图,该内裙部在内裙部的一侧上具有窗口,该窗口暴露出下面的织造织物。
图12示出在图11所示的窗口处将缝合线穿过织造织物。
图13示出将图11所示的内裙部缝合到假体瓣膜框架的相邻支柱。
具体实施方式
图1至图2示出根据一个实施例的假体瓣膜10的两个不同视图。所示瓣膜适于植入原生主动脉瓣环中,然而在其他实施例中,它可以适于植入心脏的其他原生瓣环中。瓣膜10可以具有若干主要部件:支架或框架12、瓣膜结构14和裙部组装件15。裙部组装件15可以包括内裙部16,并且可选地包括外裙部18。
瓣膜结构14(或小叶结构)可以包括三个小叶40(然而可以使用更多或更少数量的小叶),从而共同形成小叶结构,可以将小叶结构布置成以三尖瓣布置塌缩。瓣膜结构14被配置为允许血液在从假体瓣膜的入口端48到假体瓣膜的出口端50的方向上流过假体瓣膜10,并且阻止血液在从出口端50到入口端48的方向上流过假体瓣膜。
每个小叶40理想地具有弯曲的大致U形的入口或尖头边缘52。以这种方式,瓣膜结构14的入口边缘具有起伏的弯曲的扇形形状。通过以这种扇形几何形状形成小叶,可以减小小叶上的应力,这进而改进瓣膜的耐用性。此外,通过扇形形状,可以消除或至少最小化在每个小叶的腹部(每个小叶的中央区域)处的褶皱和波纹,这些褶皱和波纹可能在那些区域引起早期钙化。扇形几何形状还减少了用于形成小叶结构的组织材料的量,从而允许瓣膜的流入端处的更小更均匀的卷曲轮廓。小叶40可以由心包组织(例如牛心包组织)、生物相容性合成材料或本领域已知并且在美国专利No.6,730,118中描述的各种其他合适的天然或合成材料形成。
图3示出裸露的框架12。在所描绘的实施例中,框架12具有限定入口端54和出口端56的环形形状,并且包括多个支柱(或框架构件)。框架12可以形成有多个周向间隔开的狭缝或连合窗口20(在所示实施例中为三个),其适于将瓣膜结构14的连合58安装到框架,如美国专利公开US2012/0123529中更充分描述的。
框架12可以由本领域中已知的各种合适的可塑性扩张材料(例如,不锈钢等)或自扩张材料(例如,镍钛诺)中的任何一种制成。当由可塑性扩张材料构造时,框架12(以及因此瓣膜10)可以在递送导管上被卷曲成径向压缩状态,并且然后通过可膨胀球囊或其他合适的扩张机构在患者体内扩张。当由自扩张材料构造时,框架12(以及因此瓣膜10)可以被卷曲到径向压缩状态,并且通过***递送导管的护套或等效机构中而被限制在压缩状态。一旦进入体内,就可以将瓣膜从递送护套推进,从而允许瓣膜扩张到其功能尺寸。
可以用于形成框架12的合适的可塑性扩张材料包括但不限于不锈钢、镍基合金(例如,钴铬合金或镍钴铬合金)、聚合物或其组合。在特定实施例中,框架12由镍钴铬钼合金制成,诸如MP35NTM(SPS Technologies的商品名),其等效于UNS R30035(由ASTM F562-02覆盖)。MP35NTM/UNS R30035按重量计包含35%的镍、35%的钴、20%的铬和10%的钼。已经发现,使用MP35N形成框架12提供优于不锈钢的结构效果。特别地,当MP35N用作框架材料时,需要较少的材料来实现相同或更好的抗径向和挤压力性能、抗疲劳性能和抗腐蚀性能。此外,由于需要的材料较少,因此可以减小框架的卷曲轮廓,从而提供了较低轮廓的瓣膜组装件,用于经皮递送到体内的治疗位置。
参照图3和图4,在所示实施例中的框架12包括:下部第一排I的成角度支柱22,其端对端布置并且在框架的流入端处周向延伸;第二排II周向延伸的成角度支柱24;第三排III周向延伸的成角度支柱26;第四排IV周向延伸的成角度支柱28;以及在框架的流出端56处的第五排V周向延伸的成角度支柱32。可以使用多个基本笔直的轴向延伸的支柱34将第一排I的支柱22与第二排II的支柱24互连。第五排成角度支柱32通过多个轴向延伸的窗口框架部分30(其限定连合窗口20)和多个轴向延伸的支柱31连接到第四排IV成角度支柱28。每个轴向支柱31和每个框架部分30从由两个成角度支柱32的下端的会合点所限定的位置延伸到由两个成角度支柱28的上端的会合点所限定的另一位置。
每个连合窗口框架部分30安装小叶结构14的相应连合58。可以看出,每个框架部分30在其上端和下端固定到相邻排的支柱以提供稳健配置,这与用于支撑小叶结构的连合的已知悬臂支柱相比,增强了在瓣膜的周期性加载下的抗疲劳性。这种配置使得能够减小框架壁的厚度以实现瓣膜的较小的卷曲直径。在特定实施例中,在内直径和外直径之间测量的框架12(图3)的厚度T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孔。在框架12的流入端处,支柱22、支柱24和支柱34限定下排单元,这些下排单元限定开口36。第二排支柱24、第三排支柱26和第四排支柱28限定两排中间单元,这些中间单元限定开口38。第四排支柱28和第五排支柱32连同框架部分30和支柱31一起限定上排单元,这些上排单元限定开口60。开口60相对大,并且其尺寸被设计成当框架12被卷曲时,允许小叶结构14的一部分突出或凸起到开口60中和/或穿过开口60,以便最小化卷曲轮廓。
如图4所示,支柱31的下端在节点或接头44处连接到两个支柱28,并且支柱31的上端在节点或接头46处连接到两个支柱32。支柱31的厚度可以小于接头44、46的厚度。接头44、46连同接头64(每个接头联结两个相邻的支柱32)防止当框架12处于卷曲状态时开口60完全封闭。因此,支柱31以及接头44、46和64的几何形状有助于在卷曲状态下在开口60中创建足够的空间,以允许小叶的一部分向外突出(即,凸起)穿过开口。与将所有小叶材料限制在卷曲框架内相比,这允许瓣膜卷曲到相对较小的直径。
框架12被配置为在预定球囊压力下,特别是在支撑小叶结构14的框架的流出端部处,防止或至少最小化瓣膜的可能过度扩张。在一方面,框架被配置为在支柱之间具有相对较大的角度42a、42b、42c、42d、42e。角度越大,打开(扩张)框架所需的力越大。这样,可以选择框架的支柱之间的角度以在给定的打开压力(例如,球囊的膨胀压力)下限制框架的径向扩张。在特定实施例中,当框架扩张至其功能尺寸时,这些角度至少为110度或更大,并且更特别地,当框架扩张至其功能尺寸时,这些角度为至少120度或更大。美国专利公开No.2012/0123529进一步描述了框架12以及可结合在假体心脏瓣膜中的框架的其他配置。
如图1至图2所示,裙部组装件15可以包括位于框架12内部的内裙部16和位于框架12外部的外裙部18。外裙部18可以包括多个周向间隔开的延伸部分或突起66和沿外裙部的流出边缘(在所示实施例中为上边缘)形成的相邻突起之间的凹陷68。在其他实施例中,外裙部18可以具有笔直的流出边缘,而没有任何突起或凹陷。
外裙部18的流入(下)边缘和流出(上)边缘可以通过例如热结合、粘合剂和/或缝合而固定到框架12和/或内裙部16。如所示实施例中所示,沿着外裙部18的流出边缘的突起66可以用缝合线70固定到框架的支柱,而相邻突起之间的凹陷68可以不附连到框架12和内裙部16。外裙部18通过抵靠原生瓣膜环的组织密封而用作假体瓣膜10的密封构件,从而有助于减少通过假体瓣膜10的瓣周渗漏。
在一些实施例中,如图1至图2所示,当假体瓣膜10处于径向扩张配置时,外裙部18可以被配置为从框架12径向向外延伸。可替代地,外裙部18可以被配置为与框架12形成紧密配合,使得当假体瓣膜10处于径向扩张配置时,外裙部抵靠框架12的外表面。外裙部18可以由各种合成材料或天然组织(例如,心包组织)中的任何一种形成。合适的合成材料包括各种生物相容性织物(例如,PET织物)或非织物膜中的任何一种,包括下面公开的用于内裙部16的增强层88的任何材料。外裙部18的进一步细节也公开在美国专利公开US2012/0123529中。
如图1至图2进一步所示,所示实施例中的内裙部16从框架的入口端54延伸到第四排IV成角度支柱28。在其他实施例中,内裙部16可以从框架的入口端54延伸到短于第四排IV支柱的位置(例如,延伸到第二排II支柱或第三排III支柱),或者内裙部可以延伸框架12的整个高度(例如,(从入口端54到出口端56)。在可替代实施例中,内裙部16可以被定位成和/或大小被设计成在框架12的不同于图1至图2所示的配置的部分上延伸。例如,在一些实施例中,内裙部16的流入端可以与框架12的入口端54轴向间隔开。
尽管内裙部16通常是管状或柱状的形状(在垂直于瓣膜的纵向轴线的平面中的横截面轮廓中形成完整的圆形),但是内裙部16不需要沿着框架12的内表面在周向方向上延伸360度。换句话说,内裙部16可以具有不是完整圆形的横截面轮廓(在垂直于瓣膜的内腔的轴线的平面中)。内裙部16可以首先形成为扁平条,并且然后通过(例如通过缝补、热结合和/或粘合剂)将相对的边缘部分耦连在一起而形成为环形形状。可替代地,内裙部16可以直接形成为环形形状,例如,通过如下所述将内层16构造在柱形芯轴上。
参照图5,内裙部16具有限定内裙部的内表面的第一侧72和限定内裙部16的外表面的第二侧74。如下文更充分描述的,内裙部16的面向框架侧74可以具有一个或多个窗口或开口,通过该窗口或开口暴露出以其他方式被包封的织物层。可以在那些窗口处将缝合线穿过内裙部16的织物层,以将内裙部16固定到框架12。为了说明的目的,在图5中省略了外裙部18。
当内裙部16安装到框架12时,内裙部16的第一侧72向内面向位于假体瓣膜10内部的小叶结构14,并且内裙部16的第二侧74向外面向框架12的内表面。在特定实施例中,内裙部16可以包括夹在第一覆盖构件84和第二覆盖构件86之间的增强层88。在代表性实施例中,增强层88可以是织物层。第一覆盖构件84和第二覆盖构件86也可以被称为包封层,并且分别形成所示内裙部16的内层和外层。在特定实施例中,增强层88的内表面可以被第一侧72上的第一覆盖构件84完全覆盖,并且增强层88的外表面被第二侧74上的第二覆盖构件86部分覆盖,其中第二覆盖构件86限定一个或多个窗口或开口90(参见图10),这些窗口或开口90暴露第二侧74上的增强层88。
增强层88可以增强内裙部16以抵抗撕裂。它也可以用作锚固层,用于将内裙部16缝合到框架12并且用于支撑小叶40的尖头边缘部分,如下文更全面地描述。另外,当处于扩张配置时,增强层88与包封层84、86的协作可以帮助减少(或防止)通过假体瓣膜10的瓣周渗漏。
在一些实施例中,增强层88可以包括由各种类型的天然或合成纤维(或长丝、或纱线或股线)织造(woven)而成的织造织物,这些天然或合成纤维包括但不限于:纱布、PET纤维(例如Dacron)、聚酯纤维、聚酰胺纤维等。在某些实施例中,增强层88可以具有针织或编织结构而不是织造结构。在某些实施例中,增强层88可以包括各种非织造织物中的任何一种,诸如毡。增强层88的厚度可以变化,但是可以小于6密耳(mil),并且理想地小于4密耳,甚至更理想地为约2密耳。
可替代地,增强层88可以包括由具有对准的或部分对准的(例如,平行的)分子链的各种半结晶聚合物材料或热塑性塑料中的任何一种形成的一个或多个层或膜。这样的材料可以表现出各向异性的机械性能,诸如沿着分子链的纵向方向增加的机械强度。合适的半结晶聚合物材料可以包括例如PTFE、PET、聚丙烯、聚酰胺、聚醚醚酮(PEEK)等,其层或膜可以位于包封层84、86之间并由其包封,以增强内裙部16。除非另有说明,否则在下面的描述中将织物层描述为示例性增强层,以用于说明的目的,但是应当理解,具有足够高拉伸强度的非织物层也可以用作增强层。
包封层84、86可以由任何合适的生物相容性材料制成。理想地,包封层84、86包括比织物层磨损性相对更小的材料,以减少小叶40的磨损。包封层84、86可以包括例如由非织造纤维或非纤维材料形成的薄膜或膜。用于形成层84、86的生物相容性材料可以是不可吸收的聚合物材料(即,一旦植入体内就不会溶解的材料),并且该材料可以是弹性的。另外,任何包封层84、86可以具有促进周围组织向内生长的多孔微结构,以帮助将假体瓣膜10固定在体腔中。
包封层材料的示例包括但不限于ePTFE、未扩张的多孔PTFE、聚酯或扩张的PTFE纱线、PTFE、超高分子量聚乙烯(UHMWPE)、其他聚烯烃、复合材料(诸如带有PTFE纤维的ePTFE,或带有嵌入的UHMWPE纤维的UHMWPE膜)、聚酰亚胺、硅树脂、聚氨酯、水凝胶、氟乙基聚丙烯(FEP)、聚丙基氟化胺(PFA)、其他相关的氟化聚合物或这些材料中任何一种的各种组合。在特定实施例中,包封层84、86可以通过由合适的聚合材料(例如,ePTFE管或UHMWPE管)制成的相应的管形成,当经受热处理时,这些相应的管可以彼此结合。在一些实施例中,包封层84、86可以由相同类型的材料形成,然而根据特定应用,可以使用不同的材料来形成包封层。
微多孔ePTFE管可以通过许多众所周知的方法来制造。扩张的PTFE通常是通过将颗粒状的干燥聚四氟乙烯树脂与液体润滑剂混合以形成粘稠的浆料来生产的。混合物可以被倒入通常为柱形模具的模具中,并且被压缩以形成柱形坯料。然后坯料可以通过挤出模冲压挤压成管状或片状结构,在本领域中称为挤出物。挤出物包含被称为“湿PTFE”的挤出PTFE-润滑剂混合物。湿PTFE具有高结晶状态的聚结的粘合的PTFE树脂颗粒的微观结构。挤出后,可以将湿PTFE加热到低于润滑剂的闪点的温度,以使主要部分润滑剂从PTFE挤出物中挥发。所得的不含主要部分润滑剂的PTFE挤出物在本领域中称为干燥PTFE。然后可以使用本领域已知的合适的机械设备将干燥PTFE单轴扩张、双轴扩张或径向扩张。扩张通常在升高的温度下进行,例如,高于室温但低于327℃,这是PTFE的结晶熔点。干燥PTFE的单轴扩张、双轴扩张或径向扩张导致聚结的粘合的PTFE树脂形成从节点(聚结的PTFE区域)发出的原纤维,其中原纤维被取向成平行于扩张的轴线。一旦扩张,干燥PTFE称为扩张的PTFE(“ePTFE”)或微多孔PTFE。
UHMWPE由非常长的聚乙烯链制成,其分子量数以百万计,通常在2至600万之间。其为高度耐腐蚀性化学物质,具有极低的吸湿性和极低的摩擦系数。它具有自润滑性,并且高度耐磨。UHMWPE使用压缩模制、冲压挤压、凝胶纺丝和烧结进行加工。UHMWPE以粉末、片状或棒状以及纤维形式商购。
包封层84、86可以通过多种方式形成。例如,在一个示例中,可以使用电纺工艺来形成包封层84、86,该电纺工艺使用电力将聚合物溶液或聚合物熔体的带电的线牵引直至纤维直径为几百纳米的量级。在另一个示例中,可以使用离心纺丝技术来形成包封层84、86。在离心纺丝中,纺丝液被置于旋转的纺丝头中。当转速达到临界值时,离心力克服了纺丝液的表面张力,从而从纺丝头的喷嘴尖端喷射出液体射流。然后,射流经历拉伸工艺,并且最终沉积在收集器上,形成固化的纳米纤维。在又一示例中,可以使用大气等离子体喷涂(APS)技术形成包封层84、86,该技术是热喷涂工艺的特殊变型。APS使用电弧将流动的工艺气体离子化,可以控制热气流以融化非常宽范围的粉末原材料,从而将高质量涂料施加到目标对象。在其他实施例中,包封层84、86可以使用任何其他合适的方法来形成,包括诸如浸涂、喷涂或熔融纺丝。例如,可以通过将织物层88浸入液化聚合物材料中,并且然后允许液化聚合物材料固化来形成包封层84、86中的任一个。
图6至图10示出形成内裙部16的一种示例性工艺。尽管下面描述了电纺的使用,但是其本质上是示例性的,并不旨在作为限制。应当理解,也可以使用用于沉积聚合物层的其他工艺,例如离心纺丝、APS、浸涂以及如上所述的其他工艺。
首先,如图6所描绘的,可以通过电纺(或使用其他技术)将包括第一涂层材料的第一覆盖构件84围绕柱形芯轴100的外表面周向沉积。如本领域中已知的,电纺***可以包括喷丝头,该喷丝头用于挤出聚合物溶液或聚合物熔体以形成纤维。为了将第一覆盖构件84沉积在芯轴100上,电纺***可以被配置为使纤维挤出喷丝头绕芯轴100以圆周运动旋转。可替代地,纤维挤出喷丝头可以被配置为静止,而芯轴100被放置在喷丝头的前面,并围绕其纵向轴线旋转。
第二,如图7所描绘的,织物层88可以被放置在第一覆盖构件84上。织物层88可以是一片织物材料的形式,该织物材料紧密地围绕第一覆盖构件84缠绕。例如,如上所描绘的,织物层88可以具有织造结构,该织造结构包括彼此垂直延伸的经向纤维和纬向纤维的线。在可替代实施例中,织物层88也可以被沉积在第一覆盖构件84上。例如,如上所述,织物层88可以包括非织造织物,其本身可以通过电纺形成并且理想地是具有比层84、86相对更高的拉伸强度。在另一个示例中,层88可以是围绕第一覆盖构件84缠绕的预成型的编织材料。在另一个示例中,可以通过围绕第一覆盖构件84编织一个或多个纱线或细丝以形成围绕第一覆盖构件的编织层来形成层88。
第三,如图8所描绘的,可以在织物的选择区域94处在织物层88上放置一个或多个掩模92。第四,如图9所描绘的,包含第二涂层材料的第二覆盖构件86可以通过电纺(或使用其他技术)被沉积在被掩蔽的织物层88上。接下来,如图10所描绘的,在沉积第二覆盖构件86之后去除掩模92。因此,创建了对应于选择区域94的一个或多个窗口90,以使窗口90暴露下面的织物层88。
在图8至图9所示的实施例中,掩模92可以临时覆盖织物层88的选择区域94,并且防止这些选择区域94被第二覆盖构件86的第二涂层材料沉积。可替代地,选择区域94可以在功能上被掩蔽而不需要应用物理掩模94。例如,可以对纤维挤出喷丝头相对于芯轴100的相关移动和操作(例如,激活和/或去激活)进行编程,使得第二覆盖构件86的第二涂层材料只能沉积在织物层88的选择区域94之外的部分上。
在图8至图9中描绘的实施例中,示出掩模92的三个环形带,分别对应于沿着织物层88的外周边的三个选择区域94。作为结果,在去除掩模92之后,创建三个环形窗口90,如图10所描绘的。在其他实施例中,掩模92中的任何一个可以具有非环形的形状,使得对应的选择区域94和所得的窗口90不完全包围织物层88。例如,掩模92中的任何一个可以在定制位置处具有定制形状以便创建定制窗口90。此外,尽管在所示实施例中示出三个窗口90,但是内裙部可以形成有数量更少或更多的窗口,并且这些窗口可以被安置在沿着裙部的任何位置。例如,在一些实施例中,内裙部可以形成有一排或多排周向延伸的窗口,其中每排包括多个周向间隔开的窗口。在其他实施例中,一个或多个窗口可以沿着内裙部的入口边缘和/或出口边缘形成。
虽然未示出,但是应当理解,在上述每个步骤中,可以提供锚固机构以临时固定每个层的位置。作为非限制性示例,PTFE带的层可以围绕第二覆盖构件86的一端或两端进行缠绕,以帮助在随后的处理期间将第二覆盖构件86的方位固定到组装件的下层和芯轴100。
在代表性实施例中,织物层88具有多个开口,这些开口允许第一覆盖构件84和第二覆盖构件86通过那些开口熔合在一起。在一个示例中,织物层88中的开口可以通过机织(weave)、编织(braid)或针织(knit)纤维或纱线以形成织物层而产生。在另一个示例中,织物层88可以具有带开口的非织造多孔结构。在另一个示例中,诸如当使用非织造织物(例如,毡)形成织物层时,可以通过在织物层中切割(例如,激光切割)开口来形成织物层88中的开口。
在一个示例性实施例中,第一覆盖构件84和第二覆盖构件86之间通过织物层88中的开口进行熔合可以与将第二覆盖构件86沉积在被掩蔽的织物层88上的工艺同时发生。当从喷丝头挤出的第二涂层材料沉积在织物层88上以形成第二覆盖构件86时,一些第二涂层材料可以穿透织物层88中的那些开口,并且与第一覆盖构件84中的纤维熔合。
在其他实施例中,第一覆盖构件84和第二覆盖构件86之间的熔合可以在第二覆盖构件86沉积在被掩蔽的织物层88上之后发生。例如,图10所示的组装件可以经历包封工艺从而使组装件经受热和/或压力,以使第一覆盖构件84和第二覆盖构件86通过织物层88中的开口彼此结合。此外,织物层88的轴向长度可以短于第一覆盖构件84和第二覆盖构件86,以促进第一覆盖构件84和第二覆盖构件86在其相应端部处的结合,以将织物层88包封在它们之间。在美国专利公开US2014/0209238和US2016/0317305中描述了类似的包封工艺。
在示例性实施例中,ePTFE可以用作用于沉积第一覆盖构件84的第一涂层材料和/或用于沉积第二覆盖构件86的第二涂层材料。可替代地,可以使用其他材料,诸如UHMWPE、聚氨酯复合材料或者上述任何其他不可吸收的聚合物材料。内裙部16理想地可以具有层压结构,其中织物层88被夹在两个熔合层(第一覆盖构件84和第二覆盖构件86)之间。在一些实施例中,相同的材料可以用于沉积第一覆盖构件84和第二覆盖构件86。由于层间熔合或结合,第一覆盖构件84和第二覆盖构件86可以合并在一起,从而有效地创建单一结构(即,没有物理层间边界),织物层88被包封在该单一结构中。第一覆盖构件84的密度可以与第二覆盖构件86的密度相同或不同。在其他实施例中,用于沉积第一覆盖构件84的第一涂层材料可以与用于沉积第二覆盖构件86的第二涂层材料不同。
在第一覆盖构件84和第二覆盖构件86牢固地熔合在一起以包封织物层88之后,可以将内裙部16从芯轴100上移除。内裙部16的一个或两个端部可以被修剪以实现内裙部的期望高度。然后内裙部16可以被安装到框架12。
尽管图6至图10和上面的描述示出形成环形内裙部16的工艺,但是应当理解,可以使用相同的工艺来形成外裙部18。此外,如上所述,内裙部16可以首先形成为扁平条,并且然后通过将其两个相对边缘耦连在一起而形成为环形。为了形成扁平条,可以将第一覆盖构件84和第二覆盖构件86以及织物层88构造在扁平基板上,而不是如上所述的柱形芯轴100。
尽管上述工艺使用掩膜在内裙部16的第二覆盖构件86上创建窗口90,但是应当理解,可以使用其他方法来创建那些窗口90。例如,第二覆盖物构件86可以首先沉积在织物层88的整个表面上。然后,可以例如通过激光切割、化学侵蚀或其他方式来定位和去除第二覆盖构件86上的选择区域94。作为结果,窗口90可以被创建在第二覆盖构件86上的选择区域94处,从而在其中暴露下面的织物层88。在另一个示例中,第二覆盖构件86可以被预制造,使得在选择区域94中没有第二涂层材料。然后,可以将预制造的第二覆盖构件86围绕织物层88进行缠绕。作为结果,织物层88可以通过在选择区域94处创建的窗口90暴露。然后,组装件(第一覆盖构件84、织物层88和第二覆盖构件86)可以经受如上所述的基于热和/或压力的包封工艺,导致第一覆盖构件84和第二覆盖构件86彼此结合。
内裙部16可以在窗口90的位置处缝合到框架12。例如,内裙部16可以放置在框架12的内部。窗口90的方位可以布置成使得通常分别对应于第一排支柱22、第二排支柱26和第三排支柱28,然而可以使用其他配置。内裙部16还可以通过缝合线固定到第一排支柱、第三排支柱和第四排支柱中的支柱,该缝合线围绕支柱并且在窗口90的位置处穿过织物层88延伸,如下面结合图11至图13进一步描述的。由于在所示实施例中的窗口围绕内裙部的整个周边连续延伸,所以可以沿着每排支柱和在每个窗口90处的织物层88形成连续周向延伸的锁缝针迹(whip stitch)。
如上所述,窗口90可以在选择位置处被创建并且可以具有各种形状中的任何一种,从而允许将内裙部在不同位置处缝合到框架。例如,如上所述,内裙部可以形成有成排的周向间隔开的窗口,这可以允许诸如在内裙部的更容易产生拉力或压力的选择部分处放置单独的缝合线或缝线,该缝合线或缝线不沿着整排支柱连续延伸。
图11至图13示出将内裙部16缝合到框架12的示例性方法。图11示出具有第一侧72和第二侧74的内裙部16的一部分的横截面图。如上所述,内裙部16具有包封的织物层88,该织物层夹在第一侧72上的第一覆盖构件84和第二侧74上的第二覆盖构件86之间。图11还描绘了内裙部16的第二覆盖构件86上的窗口90,其暴露下面的织物层88。当使用相同的材料形成可以熔合或结合在一起以形成包封织物的单个整体结构的包封层84、86时,可能不存在层间边界(如虚线所示)。在所描绘的实施例中,织物层88被示出为具有包括织造细丝、纤维或纱线96的织造结构。织造细丝96理想地具有足够的强度以用作锚固件以保持缝合线98,如下所述。
图12示意性地示出如何通过窗口90将缝合线98穿过织物层88和第一覆盖构件84之间。在所描绘的实施例中,缝合线98被附连到针102。针102的尖端108理想地是钝的。通过使针102从第二侧74滑动并且穿过窗口90,同时在针尖端108处施加轻力,第一覆盖构件84可以被稍微推离织物层88,从而为针102创建用于***在第一覆盖构件84和织物层88之间的空间。如图所示,针102和附连的缝合线98可以从窗口90的第一端104滑入织物层88,在窗口90(例如96a和96b)暴露的一根或多根细丝96的后面穿过,并且然后从窗口80的第二端106处滑出织物层88。以这种方式,缝合线98没有延伸穿过内裙部16的整个厚度。在一些实施例中,第一覆盖构件84可以不通过***针102与织物层88分离(如图12所描绘的),在这种情况下,针102和附连的缝合线98可以部分地穿过第一覆盖构件84的厚度,但不延伸穿过内裙部的整个厚度。
图13示意性地示出将内裙部16的织物层88缝合到框架12的相邻支柱22。理想地,内裙部16的第一侧72向内面向位于假体瓣膜10内部的小叶结构14,并且内裙部16的第二侧74向外面向框架12。通过将针102和附连的缝合线98通过窗口90穿过织物层88和第一覆盖构件84之间,窗口80的第一端104和第二端106之间的织造细丝96(例如96a和96b)可以共同用作固定缝合线98的锚固件。然后可以将缝合线98围绕相邻的支柱22进行缠绕,从而将那些织造细丝(例如96a和96b)固定到相邻的支柱22。因此,内裙部16可以牢固地附连到框架12。图13出于说明的目的描绘了支柱22。应当理解,内裙部16可以以类似的方式缝合到框架的其他支柱(例如26、28、32)。
如上所述,织物层88也可以具有不具有明显的织造线96的非织造结构。在这种情况下,缝合线98可以被附连到具有尖头的针。针可以用于刺穿织物层88并且使缝合线98穿过织物层。以这种方式,织物层88的在窗口90的第一端104和第二端106之间的部分可以用作固定缝合线98的锚固件,这进而将织物的该部分固定到相邻的支柱22。因此,内裙部16可以牢固地附连到框架12。
因为缝合线98在第一覆盖构件84和织物层88之间布设,所以它没有在内裙部16的第一侧72上暴露。换句话说,缝合线98被第一覆盖构件84覆盖。织物层的内表面也被第一覆盖构件覆盖。因此,可以避免在假体瓣膜10的工作周期期间由于小叶40与内裙部16之间以及小叶40与缝合线98之间的反复接触而引起的小叶40的磨损。理想地,仅在第二覆盖构件86上的一个或多个窗口90处将内裙部16缝合到框架12,从而可以避免小叶40的可移动部分与缝合线98之间的接触。另外,第一覆盖构件84理想地覆盖织物层的内表面的整个范围,或者至少覆盖织物层的在假体瓣膜的工作周期期间将另外与小叶的可移动部分接触的部分。在一些实施例中,缝合线98可以诸如在内裙部上的不会与小叶的可移动部分接触的位置处穿过内裙部的整个厚度。
如上所述,小叶40可以在它们的相邻侧彼此固定以形成连合58。每个连合58可以被固定到框架12的对应连合窗口20,如美国专利公开No.2012/0123529所述。小叶40的流入或尖头边缘52可以沿着缝合标线缝合到内裙部16,该缝合标线跟踪小叶结构的扇形流入边缘的曲率。织物层88可以提供保持缝合线所需的强度。任何合适的缝合线(诸如Ethibond缝合线)都可以用于将小叶40固定到内裙部的织物层88。
在一些实施例中,在将内裙部16安装到框架之前,小叶40的流入边缘52被固定到内裙部16。在将小叶40固定到内裙部16之后,内裙部被如上所述地固定到框架上,并且小叶的连合58被安装到框架。在其他实施例中,内裙部16可以在没有小叶的情况下安装到框架,之后,小叶的流入边缘52然后被固定到内裙部。
在某些实施例中,小叶40的流入边缘52可以经由薄的PET增强条(未示出)固定到内裙部,如美国专利US7,993,394中公开的。如美国专利US7,993,394所述,增强条可以被缝合到小叶的流入边缘。然后增强条和小叶的下边缘可以被缝合到内裙部16。理想地,增强条被固定到小叶40的内表面,使得当小叶和增强条被固定到内裙部时,小叶的流入边缘52被夹在增强条和内裙部之间。增强条实现了牢固的缝合并且保护了小叶结构的心包组织免于撕裂。
如上所述,外裙部18可以以与内裙部16类似的方式构造。也就是说,外裙部18也可以具有夹在包封层84、86之间的增强层(例如,织物层88)。类似地,窗口90可以被创建在包封层84、86中的一个上。由于外裙部18被附连到框架12的外部,因此理想地外层18被布置成使得框架12面向外裙部18的具有窗口90的一侧。在这种布置中,外裙部18可以通过将包封的织物层88通过面向框架的窗口90缝合到框架12而被附连到框架12。
在另一个实施例中,外裙部18可以具有仅涂覆有包封层84、86中的一个的织物层88。在外裙部18被附连到框架12时,外裙部18可以被布置成使得织物层88的未涂覆侧向内面向框架12,从而外裙部18可以通过将暴露的织物层88缝合到框架12上而被附连到框架12。
可替代地,外裙部18可以仅包括织物层88,而没有任何包封层84、86。这样,外裙部18可以被直接缝合到框架12。因为外裙部18上的缝合线不经历由于移动的小叶40而引起的反复接触,所以由于外裙部18上的缝合线引起的小叶的磨损比内裙部16上的缝合线的磨损少。通过消除一个或两个包封层84、86,外层18可以构造得更薄,从而在将瓣膜10卷曲到径向压缩状态时减小瓣膜10的整体轮廓。
一般注意事项
应该理解,所公开的实施例可以适于在心脏的任何原生瓣环(例如,肺动脉瓣环、二尖瓣环和三尖瓣环)中递送和植入假体装置,并且可以与各种递送方法(例如,逆行、顺行、经隔、经室、经心房等)一起使用。
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。所公开的方法、设备和***不应以任何方式解释为限制性的。相反,本公开涉及各种公开的实施例的所有新颖的和非显而易见的特征和方面,无论是单独地还是彼此的各种组合和子组合。方法、设备和***不限于任何特定方面或特征或其组合,所公开的实施例也不要求存在任何一个或多个特定优点或解决问题。任何示例中的技术都可以与其他示例中任何一个或多个中描述的技术结合使用。考虑到可以应用所公开技术的原理的许多可能的实施例,应当认识到,所示出的实施例仅是优选示例,并且不应被视为限制所公开技术的范围。
尽管为了方便呈现以特定的序列顺序描述了一些公开的实施例的操作,但是应当理解,这种描述方式包括重新布置,除非后面阐述的特定语言要求特定的顺序。例如,在某些情况下,顺序描述的操作可以重新布置或同时执行。此外,为了简单起见,附图可能未示出可以将所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”或“实现”之类的术语来描述所公开的方法。这些术语是所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使用的,单数形式“一个”、“一种”和“该/所述”包括复数形式,除非上下文另外明确指出。另外,术语“包括”是指“包含”。此外,术语“耦连”和“连接”通常是指电、电磁和/或物理(例如,机械地或化学地)耦连或联结,并且在没有特定相反语言时,不排除在耦连或相关联的项目之间存在中间元件。
方向和其他相对参考(例如,内、外、上、下等)可以用于促进本文中的附图和原理的讨论,但并不旨在进行限制。例如,可以使用某些术语,诸如“内侧”、“外侧”、“顶部”、“向下”、“内部”、“外部”和诸如此类。当处理相对关系时,尤其是相对于所示出的实施例,这种术语在适用时用于提供描述的一些清晰度。但是,此类术语并非旨在暗示绝对的关系、方位和/或取向。例如,对于对象,只需将对象翻转过来,“上部”就可以变成“下部”。但是,它仍然是相同的部分,并且对象仍然相同。如本文所用,“和/或”是指“和”或“或”,以及“和”和“或”。
鉴于可以将所公开的发明的原理应用于其中的许多可能的实施例,应当认识到,所示出的实施例仅是本发明的优选示例,并且不应被认为是对本发明范围的限制。相反,本发明的范围由所附权利要求书限定。因此,我们要求保护落入这些权利要求范围内的所有内容作为我们的发明。
Claims (10)
1.一种用于制造可植入假体瓣膜的方法,包括:
形成层压件,所述层压件包括设置在第一覆盖构件和第二覆盖构件之间的织物层,其中所述第二覆盖构件包括一个或多个窗口,其中所述织物层在所述一个或多个窗口处暴露;
抵靠环形框架放置所述层压件;并且
通过在所述第二覆盖构件的所述一个或多个窗口处并且围绕所述框架的一部分将缝合线穿过所述织物层来将所述层压件缝合到所述环形框架。
2.根据权利要求1所述的方法,其中所述层压件包括环形裙部,所述环形裙部的尺寸和形状被设计为覆盖所述框架中的开口,以防止血液流过所述框架的开口。
3.根据权利要求2所述的方法,其中所述裙部被定位于所述环形框架的内部。
4.根据前述权利要求中任一项所述的方法,其中所述第一覆盖构件和所述第二覆盖构件通过所述织物层中的开口彼此熔合。
5.根据前述权利要求中任一项所述的方法,其中形成所述层压件的动作包括:通过电纺形成所述第一覆盖构件,在电纺的所述第一覆盖构件上放置所述织物层,并且通过电纺在所述织物层上形成所述第二覆盖构件。
6.根据权利要求5所述的方法,其中形成所述层压件的动作进一步包括:在形成所述第二覆盖构件之前,在所述织物层上掩蔽一个或多个区域,以便当在所述织物层上形成所述第二覆盖构件时,在所述第二覆盖构件中形成所述一个或多个窗口。
7.根据权利要求1-4中任一项所述的方法,其中形成所述层压件的动作包括:用掩蔽材料掩蔽所述织物层的至少一侧上的一个或多个区域,将所述织物层浸入液化聚合物材料中,允许所述液化聚合物材料固化,并且去除所述掩蔽材料以在所述层压件中形成所述一个或多个窗口。
8.根据权利要求2所述的方法,其中所述第二覆盖构件中的所述一个或多个窗口在周向方向上围绕所述层压件连续延伸。
9.根据权利要求1所述的方法,其中所述第一覆盖构件和所述第二覆盖构件包括弹性材料。
10.根据权利要求9所述的方法,其中所述弹性材料包括ePTFE或UHMWPE或聚氨酯。
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AU2018317347B2 (en) | 2021-02-04 |
CN111182858B (zh) | 2022-04-19 |
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CA3072100A1 (en) | 2019-02-21 |
KR102619513B1 (ko) | 2023-12-28 |
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EP3668453A4 (en) | 2020-10-14 |
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