CN102905648B - 低梯度人工心脏瓣膜 - Google Patents
低梯度人工心脏瓣膜 Download PDFInfo
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Abstract
用于移植入人体的低压力梯度人工心脏瓣膜。该瓣膜包括支撑架,该支撑架具有波状流入尖突和流出连合柱,柔性小叶在流动区中附着和接合至该支撑架上。连合柱角以中间状态向外,以使流出孔区变宽。同样,设计小叶以安装入支撑架内并以瓣膜开放状态向外扩大而不产生将限制流动的突出物或凸起部分。
Description
相关申请
本申请要求于2010年5月12日提交的在35U.S.C.119(e)下的美国临时申请序号62/334,069的优先权。
技术领域
本发明涉及具有减小的压力梯度以增强流动的人工心脏瓣膜,更具体地,涉及具有改良的支架的柔性小叶瓣膜和减少通过其中的压力降的小叶结构。
背景技术
心脏瓣膜病继续成为发病率和死亡率的主要因素,其由很多疾病引起,包括风湿热和出生缺陷。目前,主动脉瓣膜疾病的主要治疗方法为瓣膜替换。最近的统计显示,瓣膜心脏病是造成美国每年接近20,000例死亡的原因,并且是大约42,000例死亡的起作用的因素。世界范围内,每年进行大约300,000例心脏瓣膜替换手术,并且这些患者中的大约一半接受所谓的机械心脏瓣膜,其由刚性的合成材料组成。剩余的患者接受生物人工(bioprothetic)心脏瓣膜替换,其利用生物来源的组织,用于柔性阻流小叶。通常,生物人工瓣膜替换具有良好的血流动力学性能并且不要求机械心脏瓣膜需要的抗凝治疗。然而,这些生物假体有时由于钙化和机械损害而失败。
用于心脏瓣膜的柔性小叶通常由生物人工同种移植或异种移植材料制成。例如,最成功的生物人工材料是整体猪瓣膜和由缝合在一起以形成三小叶瓣膜的牛心包膜制成的单独的小叶。此外,已经提出了由聚合的、纤维增强的和其他合成材料形成的柔性小叶。最常见的生物人工瓣膜构造包括在外围支撑结构周围安装的三个小叶,其自由边缘朝向流出方向伸出并在流动流的中部中会合或接合。
主动脉狭窄是主动脉瓣膜的异常变窄。很多病症引起导致主动脉瓣膜变窄的疾病。当变窄的程度变得足够明显以阻碍血液从左心室流至动脉时,产生心脏问题。
主动脉狭窄的特征是比穿过主动脉瓣膜的正常的压力梯度显著更高的压力梯度。研究表明,在症状开始后,85%的具有未手术治疗的主动脉狭窄的患者在5年内死亡。因而替换主动脉瓣膜的一个重要特征是最小主动脉压力梯度,特别是在有症状的患者中。很多主动脉人工瓣膜制造商将重点放在假体的放置(环下、环内和环上)上,以便将注意力吸引到移植具有最大可能有效的孔区的假体的重要性上。通常优选环上放置(其中缝合衬垫位于主动脉环上),因为通常可移植具有较大内孔直径的瓣膜。在具有小主动脉根的患者中,由于解剖学、身体的身高、或严重的钙化,仅可使用最小尺寸的瓣膜(例如,19mm)。有时甚至更小的瓣膜将是期望的,但小于19mm的瓣膜是商业不可得的。此外,即使利用环上移植,最小假体也可能产生20和60mm Hg之间的压力梯度和临床上显著的主动脉狭窄。在所有尺寸中,特别是小瓣膜,接近人类天然心脏瓣膜的减小的梯度是优选的并被认为提高长期患者存活率。
典型的生物人工心脏瓣膜具有支撑柔性小叶的刚性结构。不变的瓣膜座形状帮助确保可靠的小叶闭合。很多这样的人工瓣膜具有用金属插入物制成刚性的圆形缝合环,使得它们在移植后不能调整以自然改变围绕它们的主动脉的尺寸。常见的设计为在支架结构周围的缝合环,其具有三个在环的轴向方向上基本上相互平行延伸的等角距突出分支部分(leg)或连合处。该支架支撑三个单独的小叶尖突,并且缝合环相互连接突出分支部分的底部部分,由此防止其自由径向移动。为了克服这些缺点,诸如在Reul的美国专利4,291,420号和Carpentier等的美国专利6,558,418号中已经提出了柔性人工心脏瓣膜。尽管这些设计是有前景的,但常规刚性的圆形基底仍然是大部分外科医生优选的。
由Edwards Lifesciences of Irvine,CA制造的生物人工心脏瓣膜对于大部分患者已经显示了优秀的耐久性和血流动力学性能,不需要通常要求用于机械心脏瓣膜的抗凝治疗。特别地,与具有猪小叶的那些相比,Edwards的生物假体,诸如具有心包小叶的瓣膜的PERIMOUNT线,提供了优良的血流动力学性能。
对于具有低心脏输出或预期的回缩困难的一些患者而言另一个问题是少量的与一些生物人工瓣膜相关的回流(regurgitation)。典型的生物人工瓣膜中的三个柔性小叶在流动孔内会合或接合但趋向于在非常中间处的它们的会聚处分离,这允许少量回流。尽管多数患者忍受了这样的少量回流,但对心脏的任何增加的要求对于病得很严重的患者都是成问题的并可导致更缓慢的回缩。
鉴于与目前生物人工心脏瓣膜相关的实际的和所谓的缺点,经过瓣膜具有最小的压力梯度和减少的回流是期望的。
发明内容
本申请提供了用于移植入人体的低压力梯度人工心脏瓣膜。该瓣膜包括具有波状流入尖突和流出连合柱的支撑架,柔性小叶在流动区中附着和接合至所述流出连合柱。连合柱角以中间状态向外,以使流出孔区变宽。同样,设计小叶以安装在支撑架内并以瓣膜开放状态沿附着边界向外屈曲,而不产生将限制流动的突出物(shelf)或鼓出部分(belly)。
低压力梯度人工心脏瓣膜的一个实施方式包括支撑架,该支撑架包括具有交替的在尖端中端接的弓形流入尖突和弓形流出连合处的波状小叶附着边缘。支撑架的处于松弛状态的小叶附着边缘限定具有中心轴的流动容积,该流动容积具有垂直于由支撑架流入端限制的中心轴的最大流动孔区。多个柔性小叶附着至支撑架并向内延伸朝向该轴。每个小叶具有弓形尖突边缘和自由边缘,弓形尖突边缘贴合相应的支撑架尖突并沿其附着在邻近的连合处之间,自由边缘与其他小叶的自由边缘接合以提供通过瓣膜的单向流动。当瓣膜打开时,小叶的自由边缘以流出方向和在相应的流体压力下从流体流动朝向由支撑架描述的大体管状的形状向外移动。最后,松弛的支撑架角的每个连合处都径向向外以便提供大于最大流动孔区的流出孔区并引起通过瓣膜的层流。由每个连合处形成的径向向外角优选为α=4±3°。
低压力梯度人工心脏瓣膜的另一个实施方式包括支撑架,该支撑架包括具有交替的弓形流入尖突和弓形流出连合处的波状小叶附着边缘,小叶附着边缘限定具有中心轴的流动容积,并且流动容积具有垂直于由支撑架流入端限制的中心轴的最大流动孔区。多个柔性小叶附着至支撑架并向内延伸朝向该轴。每个小叶具有弓形尖突边缘和自由边缘,弓形尖突边缘贴合相应的支撑架尖突并沿其附着在邻近的连合处之间,自由边缘与其他小叶的自由边缘接合以提供通过瓣膜的单向流动。当瓣膜打开时,小叶的自由边缘以流出方向和在相应的流体压力下从流体流动朝向由支撑架描述的流动容积向外移动。此外,每个小叶具有一定尺寸并被附着至相应的支撑架尖突以便当瓣膜打开时,小叶向外展开以提供不小于最大流动孔区的流出孔区。支撑架期望地具有松弛状态并且松弛支撑架的每个连合处都径向向外成一定角度以便提供大于最大流动孔区的流出孔区并引起通过瓣膜的层流。
在前述低压力梯度人工心脏瓣膜的任一方式中,支撑架的流入尖端位于流入平面中,在流入平面内定义由尖突最低点限定的流入直径Φi,并且支撑架的连合处具有满足以下关系的从流入平面至它们尖端的轴向高度H:
同样,心脏瓣膜小叶可具有沿中心轴的接合点和从流入平面至接合点的接合高度h,在中心轴处所有三个小叶在瓣膜闭合后会合,接合高度h满足以下关系:
在本文定义的任何瓣膜中,支撑架可包括由弹性材料制成的狭长的杆状构件。例如,支撑架可被形成为没有破裂或卷曲的镍钛金属互化物连续片。在一个实施方式中,其中支撑架的连合处每个包括直立杆和其中的一系列通孔,所述一系列通孔为心脏瓣膜其他元件提供锚定点。同样,每个小叶优选具有位于它的弓形尖突边缘和它的自由边缘之间的相对的附着凸起部(tab)。当被固定在周围心脏瓣膜支撑架内时,每个小叶都具有中心区受到应力,其中小叶关于中心平面对称,并且弓形尖突边缘可由多半径的复曲线限定。该复曲线具有较小的半径,该半径在远离中心平面的两侧上逐渐减小,在与中心轴呈大约45°角时到达最大值,并逐渐增加至两个角部,在此弓形尖突边缘的两端与附着凸起部会合。
根据本申请的另一个方面,用于低压力梯度人工心脏瓣膜的小叶包括具有与自由边缘相对的弓形尖突边缘和其间相对的附着凸起部的柔性小叶。当被固定在周围心脏瓣膜支撑架内时,该小叶具有中心区受到应力,并且关于中心中间平面对称。弓形尖突边缘由多半径的复曲线限定,该复曲线具有在中心中间平面上的它的最小半径,该半径在远离中心平面的两侧上逐渐增加,在与中心轴呈大约45°角时到达最大值,并且随后逐渐减小至两个角部,在此弓形尖突边缘的两端与附着凸起部会合。自由边缘可在侧凸起部之间画出的直线上方偏离(diverge),以便当它从凸起部向内前进时形成逐渐变宽的补充的小叶材料条,直到它形成针对它的大部分长度的稳定水平,并随后在引向所述垂直的中间平面上的顶点的会聚曲线中迅速变宽。可选地,该自由边缘在侧凸起部之间画出的直线上方偏离,以形成大体成形为三角形的、顶点在垂直的中间平面上的补充的小叶材料条。该小叶期望地从牛心包膜上切下。
本发明的性质和优点的进一步理解在以下说明书和权利要求中阐明,特别是当与附图结合考虑时,其中相同的部分具有相同的参考数字。
附图说明
参考说明书、权利要求和附图,本发明的特征和优点将变得显而易见,同时变得更好理解,其中:
图1A为由流出端视图显示的现有技术的生物人工心脏瓣膜的透视图,小叶是闭合的,和图1B是从流出端显示的并旋转大约30°,小叶是打开的;
图2为通过图1A的心脏瓣膜的一个连合柱的径向截面图;
图3A-3C为图1A的生物人工心脏瓣膜的顶视平面视图、侧前视图和旋转透视图;
图4A为由流出端视图显示的本申请示例性生物人工心脏瓣膜的透视图,小叶是闭合的,和图4B是从流出端显示的并旋转大约30°,小叶是打开的;
图5为通过图4A的示例性心脏瓣膜的一个连合柱的径向截面图;
图6A为可被并入图4A的生物人工心脏瓣膜的本申请的柔性小叶的平面图;
图6B为现有技术柔性小叶的平面图;
图7为在闭合位置中的图6B示出的具有三个柔性小叶的现有技术的生物人工心脏瓣膜的顶视平面图,说明了由此形成的有时导致回流的中心孔;
图8为具有朝向中心顶点向外逐渐减小的自由边缘的本发明的可选柔性小叶的平面图;
图9为在闭合位置中的图8示出的具有三个柔性小叶的生物人工心脏瓣膜的顶视平面图,说明了由此形成的减小的中心孔;
图10为记录用于描述优选小叶的具有多维度的柔性小叶的平面图;
图11为在闭合位置中的图6A示出的具有三个柔性小叶的生物人工心脏瓣膜的顶视平面图,说明了由此形成的减小的中心孔;
图12为现有技术的柔性小叶的平面图,在其上以虚线叠加本申请的柔性小叶,指示从中心点至尖突边缘的相关“径向”维度;
图13A为在开放位置中的现有技术的生物人工心脏瓣膜单独的柔性小叶的透视图,而图13B显示了从流出端示出的平面图中的小叶,说明了由此形成的流动孔;
图14为从图13A的柔性小叶的流入端示出的平面图,说明了由此形成的流动孔;
图15为从本申请柔性小叶的流入端示出的平面图,显示了由此形成的增加的流动孔;
图16A为现有技术的生物人工心脏瓣膜的丝形式(wireform)或支撑架的透视图,和图16B为通过显示其向内角的支撑架的一个连合处的径向截面图;
图17A为用于本申请的生物人工心脏瓣膜的丝形式或支撑架的透视图,和图17B为通过显示其可能角度的支撑架的一个连合处的径向截面图;
图18A和18B为与本申请的心脏瓣膜一起使用的示例性镍钛金属互化物支撑架的缩小和放大的视图;
图19A和19B为与本申请心脏瓣膜一起使用的可选镍钛金属互化物支撑架的缩小和放大的视图;
图20示意性显示了通过现有技术的人工心脏瓣膜的血液流动,其压缩并产生湍流;
图21示意性显示了通过本申请人工心脏瓣膜的血液流动,其扩大并产生层状、低梯度流动;
图22为具有标记的重要维度和点的三小叶人工心脏瓣膜的几何构架的透视图;
图23为通过具有标记的重要维度和角度的本文描述的三小叶人工心脏瓣膜的透视截面图;和
图24A/24B、25A/25B、26A/26B和27A/27B分别为用于可根据本文描述的原理定制其形状以产生低梯度流动的三小叶人工心脏瓣膜的可选支撑架几何形状的透视图和前视图。
优选实施方式详述
本申请描述了可结合或单独使用的用于制造柔性小叶人工心脏瓣膜以减小血液通过瓣膜孔的压力梯度的一些原理。如从这样的瓣膜获得的益处的一般说明:瓣膜应该在以最小梯度向前流动时适当打开;瓣膜应该在以少量回流反向流动时适当闭合且完全闭合;瓣膜的支撑结构(例如,丝形式)在大量瓣膜打开/闭合周期期间应该能够承受疲劳应力并保持结构完整;以及柔性小叶应该承受结构应力并保持打开和闭合的结构功能,而不钙化或结构退化。
对这些属性的期望在人工心脏瓣膜设计领域中不必是新的,但基于本文描述的原理构造的瓣膜每一个都改进了,特别是通过最小化穿过瓣膜的压力梯度。应当理解,本文表达的心脏瓣膜的特性可在各种不同的柔性小叶瓣膜中实现。例如,尽管三个小叶瓣膜或三小叶瓣膜是最常见并被最多地研究的,但也可使用仅两个或更多数量的小叶。同样,除了本文说明和描述的那些,针对柔性小叶的支撑架或结构框架可采用多种形式。瓣膜支撑架可以是相对维度稳定的,或被配置为对于最小侵入性递送是可收缩的。最后,材料和制造技术可改变但仍然符合所描述的期望原理的任何瓣膜。总的来说,本申请囊括包括一种或多种这些可变方面的很多瓣膜,仅由所附权利要求所限制。
如本文所用的,“中间位置”或“中间构造”表示当各自的瓣膜和/或构架静止(例如,不动)并摆脱外部施加的负荷(例如,通过瓣膜的压力梯度,被保持设备和/或输送设备施加的用以保持瓣膜处于收缩构造的力)时瓣膜和/或构架的构造。
图1A-1B、2和3A-3C示出的现有技术的人工心脏瓣膜20包括沿垂直的流动轴通过瓣膜中部的分开的入口端22和出口端24。包织物的构架组件或支撑架26限定了瓣膜的外围和流动孔并包括连合柱28,其在流出方向上大体轴向突出,流出方向被在流入方向上弯曲的弓形尖突30分离。三个柔性小叶32连接至构架26并从其向内延伸。小叶32沿跟随连合柱28和尖突30的波状线附着。缝合可透过的缝合环34围绕瓣膜20的流入端,并且如所示出的,以非平面外围形状为特征,其在三个连合柱28附近向上波动一段短距离。也可使用平面缝合环34。
可通过整体的猪瓣膜提供小叶32,但优选单独由生物人工材料诸如牛心包膜制成。应当注意到本申请的很多优点是不依赖于柔性小叶的类型的,尽管最大的益处将通过使用多片修剪为特定尺寸和形状的牛心包膜获得,如将被说明的。尽管目前没有用于商业瓣膜,但合成材料也可用于小叶,并且术语“柔性小叶”表示包括这样的其他材料。
图1A显示了小叶32闭合的生物人工心脏瓣膜20,和图1B显示了小叶是打开的。如以下将更详细地说明的,现有技术的典型的瓣膜具有相对松软的小叶32,其在流动周期的回流部分期间通常有效地在流动孔中接合或会合,如在图1A中,并在流动周期的向前流动部分中展开,如在图1B中。由于小叶32的过多的材料,当瓣膜打开时,每个小叶下凹部分都有些向内,以形成接近它的中点的皱折或突出物36。这些突出物36向内延伸超过在流入端22限定的大体圆形的孔。此外,如图2所见,相对于中心流动轴,连合柱28从它们的流入端至它们的流出端有些向内倾斜角γ,以便限定围绕会聚的圆锥容积的旋转表面。角γ通常等于大约10°。该布置提供了流动压缩,其中如在图1B中,由柱28和处于瓣膜开放状态的中间小叶32提供的孔的尺寸小于在流入端22处限定的大体圆形的孔。大体圆锥流动柱和由松软小叶产生的向内突出物或袋的组合引入流动限制,该流动限制增加通过与光滑圆筒或理想化的管道流动相对的瓣膜的流体压力梯度。
图4A/4B和5显示了本申请的示例性生物人工心脏瓣膜40,其以与以上现有技术的瓣膜差不多相同的方法构造。即,瓣膜40包括沿通过瓣膜中部的垂直流动轴分离的入口端42和出口端44。包织物的构架组件或支撑架46限定了瓣膜的外围和流动孔并包括连合柱48,其在流出方向上大体轴向突出,该流出方向由在流入方向上弯曲的弓形尖突50分离。三个柔性小叶52连接至构架46并从其中向内延伸。小叶52沿跟随连合柱48和尖突50的波状线附着。缝合可透过的缝合环54围绕瓣膜40的流入端,并且如所示出的,以非平面外围形状为特征,其在三个连合柱48附近向上波动一段短距离。也可使用平面缝合环54。
图5显示了一个代表性的连合柱48,连合柱48相对于中心流动轴朝向它们的流出端有些向外倾斜角α,以便限定围绕偏离的(diverging)圆锥容积的旋转表面。角α期望为大约4°±3°,并且更优选至少4°。该布置提供了流动松弛,其中由柱48和处于瓣膜开放状态的中间小叶52(如在图4B中)提供的孔的尺寸大于在流入端42限定的大体圆形的孔。
应当注意,尽管当瓣膜处于中间构造中时,瓣膜的连合柱48轻微向外倾斜,但当缝合环54为周围解剖结构提供结构锚时,柱48从瓣膜的流入端向上伸展。因此,流体力趋向于从该中间位置使柱48弯曲或屈曲。例如,主动脉瓣膜在心舒期期间闭合,并且出口端44可缩小以便连合柱48从中间位置向内倾斜以定义直径D心舒期。相反,在收缩期期间,瓣膜打开并且柱48恢复到它们的中间位置或甚至有些向外弯曲以定义直径D收缩期,其中D心舒期略微小于D收缩期。通常,在收缩期期间穿过瓣膜的压力梯度足够小(例如,在一些实施方式中小于10mm Hg)使得连合柱48保持中间构造,因此其为收缩期直径D收缩期。
因为支撑架46的伸展结构优选在无形变的中间位置径向向外倾斜,所以为瓣膜提供较大的输出孔和通过瓣膜的流体内较低的压力梯度。然而,当瓣膜处于中间位置时,该向外倾斜的支撑架46可阻塞缝合环54的入口。因此,在移植期间,向外倾斜的伸展支撑结构可被瓣膜缝合环径向向内屈曲,为缝合环54提供方便的入口。
当这种向内和/或向外倾斜的中间放置的连合柱48被并入组装的人工瓣膜时,其可提供改善的通过瓣膜的血流动力学。换言之,在中间位置(和/或移植的中间构造)中,可与小叶设计(以下描述)一起调节连合柱48向内或向外倾斜的程度,以便当瓣膜被移植时,在心动周期期间获得期望的通过瓣膜的压力梯度。
图6A为并入图4A的瓣膜40的三个单独的柔性小叶52之一的平面图。如所提及的,小叶52可由一片牛心包膜形成,尽管考虑其他生物材料和甚至合成材料。每个小叶52期望地关于垂直的中间平面P对称,垂直的中间平面P将弓形尖突边缘60和相对的自由边缘62分开。尖突边缘60沿支撑架46的尖突50固定并终止于一对相反朝向的凸起部64中的任一端上。凸起部64锚定于邻近的连合柱48的上端,并优选通过支架柱66的邻近的杆并随后在支架柱外部周围包裹和相互连接,诸如在图5中所见。该技术帮助减小在支撑架46上端的小叶的附着点上的局部应力,在此张力是最大的。
自由边缘62包括帮助减少回流的依轮廓构造(contoured)的外形。特别地,自由边缘62大体径向向内延伸至对称平面的大约一半,并随后轻轻向上弯曲,或远离尖突边缘60,以形成指出的(pointed)顶点68。当小叶开放时,三个顶点68同样在图4B的瓣膜透视图中可见。这些向上指出的顶点68帮助闭合沿流动轴天然形成在三个小叶之间的小孔,如图11所见。
相反,图6B为现有技术柔性小叶70的平面图并显示了缺少沿自由边缘72的任何轮廓,其在侧凸起部73之间相对较直。图7为在闭合的位置中的具有图6B示出的三个柔性小叶70的现有技术的心脏瓣膜74的顶视平面图,说明了可引起回流的中心孔76。
图8为具有朝向中心顶点84逐渐减小的自由边缘82的本发明可选柔性小叶80的平面图。该锥形物也帮助闭合沿流动轴的前述孔和减少回流。图9为具有逐渐减小的自由边缘82的三个柔性小叶80和由此形成的减小的中心孔88的心脏瓣膜86的顶视平面图。
图10为具有记录用于描述优选小叶的具有多维度的图8的柔性小叶80的平面图。特别地,小叶具有通过自由边缘82的顶点84的对称的中心平面P。应当注意,在常规小叶的自由边缘72和改进的小叶的自由边缘82之间上方的三角形条状物以虚线示出以说明差异。从尖突边缘85上的下部中心点至延伸穿过侧凸起部之间小叶的水平线(与常规小叶的自由边缘72一致)显示小叶的有效高度H。小叶的有效宽度W在侧凸起部之间延伸。由H和W限定的有效区为经受来自通过瓣膜的流体流动的拉伸应力的小叶区(减去加固缝线外部的小边缘条)。侧凸起部具有长度TL、高度TH,并且凸起部以角β偏离水平线。
在优选实施方式中,角β在10-20°之间,侧凸起部长度TL为大约0.20英寸,侧凸起部高度TH大约0.20英寸。有效高度H在大约0.50英寸和0.90英寸(1.27-2.29cm)之间,有效宽度W在大约0.73英寸和1.20英寸(1.85-3.05cm)之间。有效高度H和有效宽度W对于小瓣膜/小叶开始小,和变得更大。瓣膜尺寸在19mm至33mm孔的范围内。因此,例如,对于19mm瓣膜而言,有效高度H为0.050英寸的低端与有效宽度W为0.073英寸的低端相配。所用组织的厚度期望在0.008-0.025英寸(0.2-0.64mm)之间。
图11为在闭合的位置中具有图6A示出的三个柔性小叶52的心脏瓣膜90的顶视平面图,说明了减小的中心孔92。每个小叶自由边缘62都包括帮助减少回流的前述依轮廓构造的外形。即,自由边缘62每个都具有接合孔92和帮助减小孔92尺寸的指出的顶点68。
图12为常规人工瓣膜(诸如图6B中)的柔性小叶70的平面图,在其上以虚线叠加图6A的柔性小叶52,以便直接比较改进的形状。具有顶点68的自由边缘62在现有技术小叶的相对直的自由边缘72的上方示出。自由边缘62的剖面从侧凸起部73在直的自由边缘72上方正好向内偏离,以使改进的小叶52更高。小叶材料100的附加条连续至顶点68并增强三个小叶自由边缘之间的接合。该条材料100大约在两个侧凸起部73之间和连接凸起部的上部角102的线的上方延伸。当条100从凸起部向内前进时,其逐渐变宽,直到它形成针对它的大部分长度的稳定水平,随后该条在引向顶点68的偏离曲线中迅速变宽。
改进的小叶52进一步包括扩大的尖突区域,如通过一系列半径所指示的。在左边的象限中,三个半径r1、r2、r3指示常规小叶尖突边缘104的曲率,如在连接侧凸起部73的下部角112的对称平面108和线110的交叉处由点106所测量的。尖突边缘104定义了半径改变的复曲线。通常,r1和r2大于r3。右边的象限显示了三个半径R1、R2、R3,其指示改进的小叶尖突边缘60的曲率。两个小叶的总体高度保持大体相同,如下部中间平面108处的会聚半径r3和R3所示,并且从凸起部至凸起部的宽度也相同。然而,改进的尖突边缘60的侧面,特别是在R2处的象限的中部中,从常规小叶扩大。改进的尖突边缘60的复曲线具有在中心中间平面108上的它的最小半径并远离中心平面逐渐增加直到它与中心中间平面呈大约45°角时到达最大值,并随后逐渐减小至两个角,在此弓形尖突边缘的两端与附着凸起部73会合。在优选实施方式中,R2≥1.1r2且R1≥1.05r1。换言之,沿改进的弓形尖突边缘的点的半径大于沿常规小叶的等同的点;至多大10%。同时,在中心中间平面处的半径保持与小叶凸起部73的下部角112处的半径相同。改进的尖突边缘60因此与常规尖突边缘逐渐偏离更大,从凸起部角112至朝向中间平面108的大约45°的点,并随后逐渐会聚直到中间平面的最低点,其中半径是相等的。还应当注意,不同尺寸的心脏瓣膜的单独的小叶具有不同的绝对值,并且可贯穿小叶区域(spectrum)实施改进的小叶半径的相对增加。
当瓣膜打开时,如参照图12所述的扩大的尖突边缘60允许小叶移动更远,离开流动路径,因此减小了通过瓣膜的压力梯度。上述的尖突边缘扩大是相对于安装在具有主要是椭圆形尖端形状的特定形状的丝形式上的常规小叶。应当理解并将在以下进一步说明的,丝形式的尖突形状可为非椭圆形,并且因此改进的小叶52的精确轮廓将相对于任何常规形状是扩大的。
为了更好地说明改变小叶尖突边缘形状的益处,图13A/13B和14显示了在开放位置中的现有技术生物人工心脏瓣膜的单独的柔性三小叶。如以上同样在图1A和1B中示出的,当瓣膜开放时,现有技术的典型的瓣膜具有下凹部分有些向内的过量的材料,以形成接近它中点的皱折或突出物36。这些突出物36向内延伸超过在流入端限定的大体圆形的孔。由向内突出物36产生的圆形孔通过在图13B和14中具有半径r的圆可见。尽管一些流动发生在该圆外部,它代表有效孔区以便与本申请的小叶进行比较。
图15为本申请的开放柔性小叶52的从流入端显示的平面图,显示了由此形成的增加的流动孔,如具有半径R的圆所指示的,与示出的现有技术的更小的孔圆r相比较。该孔半径的少量增加对应于相对大的孔区增加和减小的流动梯度。例如,从10mm增加至10.5mm的流动孔半径,增加了5%(并且孔直径仅增加1mm),其导致有效流动孔区从314mm2增加至346mm2,增加多于10%。因此小叶的向内突出物或袋的减少的益处非常明显。
图16A说明了用于现有技术的生物人工心脏瓣膜的丝形式或支撑架120。支撑架120期望包括单一杆状元件,其通常限定具有由交替的流入尖突区域122和流出连合处区域124定义的轴向波状形状的微小圆椎体。弓形尖突区域122相对于直立连合处区域124具有大的曲率半径,后者终止于尖端126。支撑架120优选包括由弹性生物相容性金属和/或塑性合金诸如镍钛金属互化物、聚丙烯等制成的狭长的杆状或丝状构件。支撑架120可利用常规丝形成技术弯曲成说明的形状,两个自由端通过沿向上延伸连合处区域124之一的相对直部分的管状卷曲(crimp)连接。为支撑架120选择的材料应该是弹性的,以允许沿它的长度屈曲,但应该具备最小的刚度,以避免用其构建的瓣膜的不对称变形。连合处区域124在流出方向上伸展并对附着其上的柔性小叶提供支撑,以便小叶不因为流体回流压力而倒置。
图16B为通过显示其向内角γ的支撑架120的一个连合处区域124的径向截面图。在构造的瓣膜中,该角对应于与图2示出的相同的角,并产生旋转朝向支撑架120流出端的向内的圆锥体。此外,该结构已经用了很多年,确保接合柔性小叶。
图17A为用于本申请的生物人工心脏瓣膜的改进的丝形式或支撑架130的透视图,其包括单个元件,该单个元件通常限定具有由交替的流入尖突区域132和流出连合处区域134定义的波状形状的微小圆锥体。弓形尖突区域132相对于直立连合处区域134具有大的曲率半径,其每一个都终止于尖端136。支撑架130优选包括由弹性生物相容性金属和/或塑性合金诸如镍钛金属互化物、聚丙烯等制成的狭长的杆状或丝状构件。此外,支撑架130可利用常规丝形成技术弯曲成说明的形状,两个自由端通过沿向上延伸连合处区域134之一的相对直部分的管状卷曲138连接。图17B为通过支撑架的一个连合处区域134的径向截面图,显示类似于图5的向外倾斜角α。丝形式结构定义了构造的心脏瓣膜流出端的外围轮廓,并因此限定了流出端的流动孔。
图18A和18B为与本申请心脏瓣膜一起使用的示例性镍钛金属互化物支撑架140的缩小和放大的视图。在该方式中,不需要如在图17A/17B的实施方式中的卷曲,而是,镍钛金属互化物构架从扁平片上切下并且随后形状设定成示出的三维剖面。支撑架140的更多细节可见于2010年5月10日提交的题目为“人工心脏瓣膜(PROSTHETICHEART VALVE (ECV-6212))”的美国临时序号61/332,885,其内容在此通过引用并入。
图19A和19B为与本申请心脏瓣膜一起使用的可选镍钛金属互化物支撑架150的缩小和放大的视图。如前,支撑架150限定了交替的连合处区域152和尖突154的波状外围。然而,尽管尖突154相对未改变,但连合处区域152每个包括直立杆156,直立杆156在经打开的三角会合点160连接尖突的连合处尖端158处终止。杆156每个都包括一系列通孔162,通孔162对可缝合的小叶凸起部或中间织物提供锚定点。该支撑架150可与其他内支架结构一起组装,诸如以上图5中的66示出的,或可被覆盖以织物并组装至仅小叶和缝合环。
图20示意性显示了通过现有技术的人工心脏瓣膜的血液流动,其压缩并产生湍流。为了说明的目的,瓣膜坐落于左心室LV和升主动脉AA之间的主动脉环上。瓣膜170示意性显示为在流入端限定的孔172以及表示连合柱和开放状态中的小叶的会聚的圆锥流出端174。因为流出孔小于流入孔,所以流动通过瓣膜170被压缩,导致湍流、旋涡和第一压力梯度。
相较之下,图21示意性显示了通过本申请的人工心脏瓣膜180的血液流动,其扩大并产生层状、低梯度流动。此外,瓣膜180安装在左心室LV和升主动脉AA之间的主动脉环中。流入端182限定了类似于图20示出的常规瓣膜的孔,但流出端184偏离中心流动轴,因此确保血液相对无障碍地从其中流动。所产生的流动线指示了层流,并且压力梯度从以上记录的第一压力梯度减小。
图22为具有标记的重要维度和点的三小叶人工心脏瓣膜的几何构架的透视图。术语如下:
A,B,C=小叶-连合处会合点,其中小叶被附着至支撑结构的连合处支柱,定义了松弛的连合处尖端的流出平面ABC和流出圆
D,E,F=尖突点,其中小叶在最接近假体流入的位置上(尖突的最低点)与支撑结构会合,限定了流入平面和环圆DEF
L,M,N=连合处点在流入环圆DEF上的投影
O=接合点或三点会合点,其中所有三个小叶在瓣膜闭合后会合
O'=接合点在流入平面DEF上的投影
Φo=圆ABC上的流出直径
Φi=圆DEF上的流入直径
H=从平面DEF至平面ABC的瓣膜连合处高度
h=从平面DEF至升高的接合点O的接合高度
AOBD=小叶#1
BOCE=小叶#2
AOCF=小叶#3
通常,心包小叶从扁平的心包组织片被预切并缝在一起,以形成用图22示出的维度构架设计的三小叶。任何三小叶设计的特征性维度应该包括流入直径和瓣膜高度h。此外,对于最常规的瓣膜设计,流出直径小于流入直径。为了描述低梯度瓣膜设计,我们应该引入新的变量,松弛角α。
对于低梯度瓣膜设计,优化的角为α=4±3°。作为比较,对于常规瓣膜,α=-10°。对于低剖面心包瓣膜设计,发现瓣膜高度的最好范围是:
接合高度为:
图23为通过具有标记的重要维度和角度的本文描述的三小叶人工心脏瓣膜的透视截面图。优化的小叶形状与孔支撑结构上的小叶附着线密切相关。已知的孔支撑结构或丝形式由具有椭圆形曲线和接近连合处尖端的线性部分的尖突限定。对于本申请,该小叶也期望具有相应的椭圆形尖突部分和相应的线性部分。
尽管典型的椭圆形-线性尖突形状是期望的,但可使用其他形状。例如,图24A/24B、25A/25B、26A/26B和27A/27B分别为用于可根据本文描述的原理定制其形状以产生低梯度流动的三小叶人工心脏瓣膜的可选支撑架几何形状的透视图和前视图。例如,在图24A/24B中,该小叶为长方形,并且丝形式为相应的来自圆柱或圆锥表面的剪切块。这样的形状可能不是优化的,但可改进小叶形状,以便最小化梯度。
尽管已经以其优选实施方式描述了本发明,但应当理解,已经使用的词语是描述性词语而不是限制性词语。因此,可在所附权利要求内进行改变,而不脱离本发明的真实范围。
Claims (16)
1.低压力梯度人工心脏瓣膜,包括:
支撑架,其包括具有交替的在尖端中端接的弓形流入尖突和弓形流出连合处的波状小叶附着边缘,所述支撑架的处于松弛状态的所述小叶附着边缘限定具有中心轴的流动容积,所述流动容积具有垂直于由所述支撑架流入端限制的所述中心轴的最大流动孔区;和
多个柔性小叶,其附着至所述支撑架并向内延伸朝向所述轴,每个小叶都具有弓形尖突边缘和自由边缘,所述弓形尖突边缘贴合相应的支撑架尖突并沿其在邻近的连合处之间附着,所述自由边缘与其他小叶的自由边缘接合以提供通过所述瓣膜的单向流动,
其中当所述瓣膜打开时,所述小叶的自由边缘在流出方向和在相应的流体压力下从流体流动朝向由所述支撑架描述的大体管状的形状向外移动,并且其中所述松弛支撑架的每个连合处都呈径向向外的角度,以便提供大于所述最大流动孔区的流出孔区和引起通过所述瓣膜的层流。
2.权利要求1所述的心脏瓣膜,其中由每个连合处形成的所述径向向外角为α=4±3°。
3.权利要求1所述的心脏瓣膜,其中所述支撑架的流入尖突限定了具有由所述尖突的最低点限定的流入直径Φi的流入平面,并且所述支撑架的连合处具有满足以下关系的从所述流入平面至它们尖端的轴向高度H:
4.权利要求3所述的心脏瓣膜,其中所述心脏瓣膜小叶具有沿所述中心轴的接合点和从所述流入平面至所述接合点的接合高度h,在所述中心轴处所有三个小叶在瓣膜闭合时会合,所述接合高度h满足以下关系:
5.权利要求1所述的心脏瓣膜,其中所述支撑架包括由弹性材料制成的狭长的杆状构件。
6.权利要求5所述的心脏瓣膜,其中所述支撑架被形成为没有破裂或卷曲的镍钛金属互化物连续片。
7.权利要求6所述的心脏瓣膜,其中所述支撑架的连合处每个包括直立杆和其中的一系列通孔,所述一系列通孔为所述心脏瓣膜的其他元件提供锚定点。
8.权利要求1所述的心脏瓣膜,其中每个小叶具有一定尺寸并被附着至相应的支撑架尖突,以便当所述瓣膜打开时,所述小叶向外展开以提供不小于所述最大流动孔区的流出孔区。
9.权利要求1所述的心脏瓣膜,其中每个小叶都具有位于它的弓形尖突边缘和它的自由边缘之间的相对的附着凸起部,当被固定在周围心脏瓣膜支撑架内时,所述小叶具有中心区受到应力,所述小叶关于中心平面对称,并且所述弓形尖突边缘由多半径的复曲线限定,所述复曲线具有在远离所述中心平面的两侧上逐渐减小的更小的半径,与所述中心轴呈大约45°角时到达最大值,并逐渐增加至两个角,在所述两个角处所述弓形尖突边缘的两端与所述附着凸起部会合。
10.低压力梯度人工心脏瓣膜,包括:
支撑架,其包括具有交替的弓形流入尖突和弓形流出连合处的波状小叶附着边缘,所述小叶附着边缘限定具有中心轴的流动容积,所述流动容积具有垂直于由所述支撑架的流入端限制的所述中心轴的最大流动孔区;
多个柔性小叶,其附着至所述支撑架并向内延伸朝向所述轴,每个小叶都具有弓形尖突边缘和自由边缘,所述弓形尖突边缘贴合相应的支撑架尖突并沿其在邻近的连合处之间附着,所述自由边缘与其他小叶的自由边缘接合以提供通过所述瓣膜的单向流动,
其中当所述瓣膜打开时,所述小叶的自由边缘在流出方向和在相应的流体压力下从流体流动朝向由所述支撑架描述的所述流动容积向外移动,和其中每个小叶都具有一定尺寸并被附着至所述相应的支撑架尖突,以便当所述瓣膜打开时,所述小叶向外展开以提供不小于所述最大流动孔区的流出孔区。
11.权利要求10所述的心脏瓣膜,其中所述支撑架具有松弛状态并且所述松弛支撑架的每个连合处都呈径向向外的角度,以便提供大于所述最大流动孔区的流出孔区和引起通过所述瓣膜的层流。
12.权利要求10所述的心脏瓣膜,其中所述支撑架的流入尖突位于流入平面内,在所述流入平面内定义由所述尖突最低点限定的流入直径Φi,并且所述支撑架的连合处具有满足以下关系的从所述流入平面至它们的尖端的轴向高度H:
13.权利要求12所述的心脏瓣膜,其中所述心脏瓣膜小叶具有沿所述中心轴的接合点和从所述流入平面至所述接合点的接合高度h,在所述中心轴处所有三个小叶在瓣膜闭合时会合,所述接合高度h满足以下关系:
14.权利要求10所述的心脏瓣膜,其中所述支撑架包括由弹性材料制成的狭长的杆状构件。
15.权利要求14所述的心脏瓣膜,其中所述支撑架被形成为没有破裂或卷曲的镍钛金属互化物连续片。
16.权利要求15所述的心脏瓣膜,其中所述支撑架的连合处每个包括直立杆和其中的一系列通孔,所述一系列通孔为所述心脏瓣膜的其他元件提供锚定点。
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US20110282440A1 (en) | 2011-11-17 |
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US11266497B2 (en) | 2022-03-08 |
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