CN105263445B - 具有增加的有效孔口面积的心脏瓣膜 - Google Patents
具有增加的有效孔口面积的心脏瓣膜 Download PDFInfo
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- 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
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
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Abstract
一种用于植入人体内的人工心脏瓣膜。该瓣膜包括具有波状流入尖瓣和流出合缝柱的线形结构,其中在流动区域内柔性小叶附接和接合到所述合缝柱。每一小叶可垂挂在尖瓣区域内线形结构顶部的上面,但具有凸起,每个凸起都在合缝柱处延伸到线形结构下面,从而连同相邻小叶的凸起一起固定。人工心脏瓣膜也可以是双线材线形结构,其中小叶夹在其间。一个线形结构可比另一个大,其中小叶在较小线形结构上面延伸。较小线形结构可具有合缝,其从较大线形结构径向向外弯曲以提供小叶凸起附接至其上的结构。
Description
相关申请
本申请根据35U.S.C.§119要求2013年9月20日提交的美国临时申请序列号61/880,688的优先权。
技术领域
本发明涉及一种具有用于增强流动而增加流动面积的人工心脏瓣膜,并且更具体地涉及一种具有改良支架和小叶结构的柔性小叶瓣膜,其增加了给定瓣膜尺寸的有效孔口面积。
背景技术
心脏瓣膜疾病一直是发病率和死亡率的显著原因,其由包括风湿热及出生缺陷的众多小病导致。目前,主动脉瓣瓣膜疾病的主要治疗手段是瓣膜置换。在世界范围内,每年进行大约30万次心脏瓣膜置换手术,许多涉及由刚性、合成材料组成的机械心脏瓣膜而其余接收对于柔性流体闭塞小叶利用生物衍生组织的生物假体心脏瓣膜。一般而言,生物假体瓣膜置换具有良好的血液动力学性能,并且不需要机械心脏瓣膜必需的抗凝治疗。
在心脏瓣膜中使用的柔性小叶典型地由生物假体同种移植物或异种移植物材料制成。例如,最成功的生物假体材料是由牛心包制成的将其缝在一起以形成三叶瓣膜的全部猪瓣膜和分离的小叶。此外,已提出由聚合物、纤维增强以及其它合成材料形成的柔性小叶。最常见的生物假体瓣膜构造包括安装在外周支撑结构周围的具有自由边缘的三个小叶,所述自由边缘朝向流出方向突出且会合或接合于流动流的中部。
主动脉瓣狭窄是由明显高于主动脉瓣瓣膜两端的正常压力梯度表征的主动脉瓣瓣膜的异常变窄。它遵循如下:置换主动脉瓣瓣膜的重要特征是最小的主动脉瓣压力梯度,典型地通过增加穿过瓣膜的有效孔口面积实现。为了植入具有最大可能的有效孔口面积的假体,解决方案包括放置假体(子环形的、内环形的和超环形的)。经常优选超环形放置(其中缝合缓冲垫(cushion)位于主动脉瓣口之上),因为通常能够植入具有较大内部孔口直径的瓣膜。然而,在具有小主动脉根部的患者中,无论是由于解剖结构、身材,还是严重钙化,仅可使用最小尺寸的瓣膜(如19毫米)。有时甚至更小的瓣膜将是可取的,但小于19毫米的瓣膜不可商购到。而且,即使有超环形植入物,所述瓣膜通常也不最大化流动孔口面积。
鉴于与当前生物假体心脏瓣膜有关的实际和认知到的缺点,针对给定的瓣膜尺寸具有增加的有效孔口面积的瓣膜是可取的。
发明内容
本申请提供了用于植入人体内的低压力梯度人工心脏瓣膜。所述瓣膜包括具有波状流入尖瓣(cusps)和流出合缝柱的线形结构 (wireform),其中在流动区域将柔性小叶附接和接合到该流出合缝柱。
本申请的一方面是人工心脏瓣膜,其包括具有交替的尖瓣和围绕外围的合缝(commissure)的第一织物覆盖的波状线形结构。第二织物覆盖的波状线形结构具有交替的尖瓣和围绕外围的合缝,并且两个线形结构的尖瓣和合缝被彼此对齐。多个柔性小叶具有夹在第一和第二织物覆盖的波状线形结构的尖瓣之间的外边缘。在一个实施例中,柔性小叶具有夹在第一和第二织物覆盖的波状线形结构的合缝之间的合缝边缘。线形结构中的一个上的织物凸起(tab)可包围至少在线形结构的尖瓣处的一小片硅胶带以提供缝合环。
第一和第二线形结构可具有相似的尺寸和形状,其中尖瓣在流入方向上弯曲且合缝限定具有在流出方向上突出的倒U形的直立合缝柱。第一线形结构半径比第二线形结构稍小且轴向尺寸比第二线形结构短,所述第二线形结构除在对齐合缝处以外从第一线形结构向外设置,其中在对齐合缝处,所述第一线形结构向外弯曲使得其合缝径向在所述第二线形结构之外,并提供用于柔性小叶的合缝凸起的缝合锚。柔性小叶优选具有夹在第一和第二线形结构之间的对齐合缝处的凸起。在一个版本中,柔性小叶的凸起环绕第一线形结构并在对齐合缝处附接至第一线形结构。
在另一个实施例中,两个线形结构的尖瓣在流入方向上弯曲并且第二线形结构的合缝限定具有在流出方向上突出的倒U形的直立合缝柱,其中第一线形结构已经将合缝截短了第二线形结构的合缝的高度的大约一半。柔性小叶可具有合缝凸起,其穿过第二织物覆盖的线形结构的倒U形合缝向外延伸并且固定到从覆盖第二线形结构的织物延伸的织物凸起。
在另一个实施例中,人工心脏瓣膜包括具有交替的尖瓣和合缝的织物覆盖的波状线形结构,所述合缝沿流出方向通常轴向延伸并限定倒U形的合缝柱。多个柔性小叶具有在线形结构的尖瓣的顶部的上面延伸的外尖瓣边缘,并且每个小叶都具有自由边缘,当被植入时该自由边缘前后移动进和出流动孔并且与其它小叶的自由边缘接合。每个小叶还在所述自由边缘的任一端处具有凸起,所述凸起在倒U形的合缝柱下面径向向外突出并且连同来自相邻小叶的凸起一起固定至倒U 形的合缝柱。
每个小叶的外尖瓣边缘是由两个向内导向的狭缝有利地中断,所述两个向内导向的狭缝中每个在小叶的任一侧上接收靠近U形的合缝的线形结构的一部分,以允许小叶凸起在U形的合缝下面通过。所述向内导向的狭缝可终止于圆形孔从而紧密符合在线形结构周围。加固材料条可被附接在圆形孔周围,或更通常地附接在狭缝终点周围。
在进一步的实施例中,人工心脏瓣膜包括具有交替的尖瓣和合缝的织物覆盖的波状线形结构,所述合缝沿流出方向通常轴向延伸并且限定倒U形的合缝柱,其中所述合缝向外弯曲并且然后通常再次轴向延伸。多个柔性小叶具有在线形结构的尖瓣的顶部的上面延伸的外尖瓣边缘,并且每个小叶都具有自由边缘,当被植入时自由边缘前后移动进和出流动孔并且与其它小叶的自由边缘接合。每个小叶在所述自由边缘的任一端处具有凸起,所述凸起围绕倒U形的合缝柱的外侧径向向外突出。合缝夹片(commissural clip)在所述合缝处的每个线形结构的顶部和小叶凸起的上面延伸并且缝合至织物覆盖的线形结构和小叶凸起以将小叶凸起固定在线形结构周围。所述合缝夹片具有封闭的椭圆形状。在线形结构上的织物凸起优选包围至少在线形结构的尖瓣处的一小片硅胶带以提供缝合环。
对本发明的本质和优点的进一步的理解在以下具体实施方式和权利要求中阐述,特别是当结合附图考虑时,附图中的相同部分具有相同的参考标记。
附图说明
本发明的特征和优点参照说明书、权利要求书以及附图将变得更明白同样变得更好理解,其中:
图1是从现有技术的柔性小叶生物假体心脏瓣膜的流出端观察的平面图;
图2是图1的心脏瓣膜的某些内部部件的透视图;
图3是图1的所组装的心脏瓣膜的局部剖视图;
图4是用于图1的现有技术的心脏瓣膜的内支架组件的透视图;
图5是图1的心脏瓣膜的合缝区域的放大透视图,其中为了清楚起见移除了织物覆盖;
图6是从现有技术的替代的柔性小叶生物假体心脏瓣膜的流出端观察的平面图;
图7是图6的心脏瓣膜的部分分解透视图,其示出某些内部部件;
图8是图6的所组装的心脏瓣膜的透视图;
图9A至图9B是分别示出闭合和张开的本申请的生物假体心脏瓣膜的部分的透视图,以及图9C是小叶一角的放大图;
图10A至图10B是穿过图9A和图9B的心脏瓣膜的尖瓣区域的径向剖视图,其示出柔性小叶和线形结构之间示例性附接;
图10C是类似于图10B的径向剖视图,并且该径向剖视图示出了在线形结构下面和上面附接柔性小叶之间流动孔口面积的差异;
图11A至图11B是分别示出闭合和张开的本申请的替选的双线形结构生物假体心脏瓣膜的部分的透视图;
图12A至图12B是穿过图11A和图11B的心脏瓣膜的尖瓣区域的径向剖视图,其示出柔性小叶和双线形结构之间的示例性附接;
图12C是类似于图12B的径向剖视图,并且该径向剖视图示出了在内部线形结构下面和上面附接柔性小叶之间流动孔口面积的差异;
图13是如在图11A和图11B中所组装的具有双线形结构的心脏瓣膜的透视图,其中该双线形结构在合缝区域处彼此交叉;
图14是本申请又一个人工心脏瓣膜的透视图,该人工心脏瓣膜在合缝区域处具有单个线形结构和夹片;
图15是双线形结构人工心脏瓣膜的透视图;
图16示出用于组装图15的双线形结构人工心脏瓣膜的过程中的一个步骤;
图17A至图17C是穿过本申请的双线形结构人工心脏瓣膜的尖瓣的径向剖视图;
图18A和图18B示出了用于本文公开的双线形结构人工心脏瓣膜的两种不同的植入配置;
图19A和图19B是在具有截短的较低线形结构的可替代双线形结构人工心脏瓣膜中的两个线形结构的分解图和组装图;以及
图20A和图20B是图19A和图19B中所组装的心脏瓣膜的合缝柱区域的详细视图,其示出了将柔性小叶附接到上部线形结构的一种方式。
具体实施方式
本申请描述了用于制造柔性小叶人工心脏瓣膜可结合或单独使用以减少通过瓣膜孔口的血液的压力梯度的某些原则。对从这样的瓣膜所获得的益处做一般陈述:所述瓣膜应适当地打开紧接着以最小的梯度向前流动;所述瓣膜应适当地且完全地关闭紧接着少反流反向流动;所述瓣膜的支撑结构(例如,线形结构)应该能够在大量的瓣膜打开/ 关闭周期期间承受疲劳应力并且保持结构完整性;以及柔性小叶应该承受结构应力并且保持打开和关闭的结构功能而没有钙化或结构退化。
在人工心脏瓣膜设计领域内对这些属性的期望不一定是新的,但是基于这里所描述的原则所构造的瓣膜对每一个属性都在改善,具体是通过增加通过给定尺寸的瓣膜的有效流动孔口面积。应当理解,这里所表达的心脏瓣膜特性可在各种不同的柔性小叶瓣膜中实施。例如,虽然三叶瓣是最常见和研究最多的,但也可使用只有两个或更多个数量的小叶。此外,除了这里所说明和所描述的那些,用于柔性小叶的支撑框架或结构骨架可采取各种形式。瓣膜支撑框架可以在尺寸上相对稳定,或为了微创递送经配置为可折叠的。最后,材料和制造技术可变化,但任何瓣膜仍符合所描述的期望原则。总之,本申请包含多个瓣膜,所述瓣膜包括这些可变方面中的一个或多个,且仅通过所附权利要求进行限制。
如这里所使用的,“中立位置”或“中立配置”是指当相应瓣膜和/或框架处于静止状态(例如,不动的)且不受外部所施加的负荷(例如,穿过瓣膜的压力梯度、通过保持和/或递送装置以将瓣膜保留在折叠配置中所施加的力)并且不朝向任何其它形状偏置时的瓣膜和/或框架配置。
此外,术语“线形结构”指由形成于连续形状限定流动孔口周围的圆周的细长杆状结构,在本文的各种人工瓣膜中用于支撑柔性小叶。典型的线形结构具有波浪起伏的形状且具有交替的流入尖瓣和流出合缝;通常每一个线形结构具有三个。这里所描述的线形结构可以是由管或线材机械加工成的,或如果由聚合物制成可模塑。连续结构可以是同质的而无接头,或可以是可被用于连接预制线材的两端的卷曲褶皱(crimp)。横截面可以是圆形、椭圆形、正方形或其它合适的配置。
如图1至图5所示的现有技术的人工心脏瓣膜20包括入口端22 和沿通过大约瓣膜中间的大致竖直的流动轴线26间隔开的出口端24 (图3)。(应当注意,通过心脏瓣膜的血液流动并不是精确地好像流过管状管道,并且因此术语“流动轴线”应该被理解为近似值并且一般指通过瓣膜孔口中心的轴线。)织物覆盖的支撑框架包括环形支架组件28和环形线形结构30。支撑框架限定了瓣膜的外围和流动孔口。支架组件28和线形结构30二者都包括合缝柱,当瓣膜用织物覆盖时,合缝柱通常沿流出方向轴向突出并结合以形成瓣膜的合缝32。支架组件28和线形结构30二者还包括弧形尖瓣,其在每两个合缝之间沿流入方向弯曲,所述每两个合缝结合形成瓣膜尖瓣34。在所示实施例中,支架组件28包括两个环状带、外部金属带和延伸到合缝处的内部聚酯带。三个柔性小叶36耦合到支撑框架并从支撑框架向内延伸。小叶36 沿着跟随合缝32和尖瓣34的波浪线附接。缝合可渗透缝合环38环绕着瓣膜20的流入端并且,如图所示,以非平面外围形状为特征,该非平面外围形状在三个合缝32附近起伏向上短距离。也可使用平面缝合环38。
小叶36可由整个猪瓣膜提供,但优选由生物假体材料如牛心包独立形成。应该注意,如将被解释的,本申请的若干优点是具有独立类型的柔性小叶,尽管用牛心包片修剪成具体的尺寸和形状将会得到最大的好处。尽管当前还没有应用于商业瓣膜,合成材料也可用于小叶,而且术语“柔性小叶”意味着包括了这样的其他材料。
如图1至图5所示的人工心脏瓣膜代表了Carpentier-Edwards二尖瓣心包瓣膜的构造,其是领先的商用生物假体瓣膜之一,可从加利福尼亚州尔湾的EdwardsLifesciences(爱德华兹生命科学公司)得到。 Carpentier-Edwards瓣膜的组装过程包括把心包小叶36缝合到织物覆盖的线形结构30上,并且然后将此子组件安装到织物覆盖的支架组件 28,该织物覆盖的支架组件28具有利用缝线连接至其上的硅胶缝合环 38。每个部件及其随后组件的织物覆盖是精细和劳动密集型的。
然而,这种具体的瓣膜构造具有已被证明的跟踪记录,部分是因为具有高度耐用的配置,其中瓣膜小叶36连接至瓣膜合缝32。参照图 5中的放大视图,小叶36延伸到线形结构30下面,并且在合缝32处向外通过相邻的线材,并且小叶36被夹在线形结构和提供支架组件28 上的织物凸起(未显示)之间。相邻小叶36的合缝凸起40通过线形结构30的合缝区域突出并缠绕在支架组件28的合缝柱周围。以这种方式缠绕小叶凸起40,并将它们固定在支架组件28的外面,当小叶紧密分布于支架组件28和线形结构30时,相对较高的内在力传递给小叶36的自由边缘,而不只是传给将小叶连接至周围结构的缝线。
图1示出小叶36闭合的生物假体心脏瓣膜20。在使用时,小叶 36打开或分离从流入端22到流出端24或是在流出方向上的血液流动。现有技术的典型瓣膜有相对松软的小叶36,它通常有效地在流动循环的后流部分期间接合或会合在流动孔口中,如图1-3中所示。合缝32 通常相对于中心流动轴线26从他们的流入端到流出端稍微向内倾斜,以便限定包围会聚锥体积的旋转表面。这样的布置提供了流动缩窄 (constriction),其中由瓣膜张开状态下的合缝柱32和小叶36提供孔口的尺寸小于一般定义在流入端22处的圆形孔口的尺寸。一般的锥形流柱和典型的瓣膜组件的组合引入流动限制,该流动限制相对于光滑的圆柱体或理想化的管道流动来说,增加了通过瓣膜的流体压力梯度。
图6至图8示出另一个商业上可用的生物假体心脏瓣膜50的构造,即从St.Paul MN(明尼苏达州圣保罗市)的St.Jude医疗公司得到的 TrifectaTM主动脉瓣瓣膜。瓣膜50包括具有三个一般轴向对齐合缝柱54 的内部聚合物支架52和包围支架的流入端的缝合环56。单片生物假体组织58环绕在支架52的外面并沿其合缝柱54用缝线60缝合至支架 52,并且也沿着与缝合环56相邻的外围线缝合。生物假体组织58略高于支架合缝柱54以有助于在表面上提供足够自由的小叶材料用于在流动孔口中的良好接合。然而,在合缝柱54之上的额外小叶材料有时会导致小叶脱垂,或不好的接合和耐久性。现有技术中其他所谓的心脏瓣膜的环绕设计包括来自意大利米兰的索林集团的Mitroflow瓣膜和来自加利福利亚州尔湾的希利实验室的Ionescu-Shiley瓣膜。
本申请提供被构造成已经证明具有耐久性并最大化有效孔口面积的人工心脏瓣膜。更具体地,这里所述的心脏瓣膜具有连接到线形结构/支架结构的柔性小叶,很像如上关于图1至图5描述的爱德华兹生命科学公司的Carpentier-Edwards瓣膜。同时,柔性小叶被附接在线形结构的至少一部分的顶部上方以增加孔口面积。线形结构可提供在一个部分或两个部分中。
现在参考图9A,本申请的人工心脏瓣膜70是由单个小叶72(三个中的一个)及其与线形结构74的三分之一的位置关系表示。线形结构74围绕整个心脏瓣膜以起伏的模式(交替的尖瓣和合缝)延伸,正如现有技术的线形结构。读者将会理解,为清楚起见,未示出诸如支架组件或缝合环的另外的构造细节。小叶72包括自由边缘76,该自由边缘76由在瓣膜限定的孔口内与其他小叶(未显示)接合。小叶的自由边缘76终止于凸起78的任一端处。正如上面描述的 Carpentier-Edwards心脏瓣膜,小叶凸起78在线形结构74的倒U形的合缝下面向外延伸,并且优选地更好地环绕支架结构(未显示)的合缝柱并且被缝到支架结构(未显示)的合缝柱。此外,小叶72具有弧形的尖瓣边缘80,其被固定在线形结构74的尖瓣周围,而不是在线形结构下面延伸并且不抵靠潜在的支架结构被夹在中间,小叶72在线形结构尖瓣74的顶部的上面延伸,如图10A所示。尽管没有显示,例如,线形结构74将再次被织物覆盖,并且外面的弧形尖瓣边缘80利用缝线将外部凸起固定在织物覆盖上。在一个实施例中,外部尖瓣边缘80 在组装期间包裹在线形结构74上面和下面。
为了确保小叶72的这种上面-下面附接,每个小叶凸起78和外尖瓣边缘80的相邻部分之间提供有间隙或狭槽86。狭槽86的宽度约等于线形结构74的直径,并且通常从小叶的弯曲的外尖瓣边缘80径向向内延伸。为了有助于防止狭槽86附近区域发生血液泄漏,能够将其他织物缝在该区域周围以固定小叶72并关闭可能泄漏的任何孔。狭槽 86的替代是在小叶72中、具有直径约等于线形结构74的直径的小孔。在这个实施例中,在凸起78和尖瓣边缘80之间的“间隙”能够是在小叶中从其尖瓣边缘到该小孔的狭缝切口(即间隙宽度为零)。替选地,狭槽86可以位于凸起78内,这有助于帮助附接并且隐藏可能发生泄漏的任何开口。
在一个实施例中,狭槽86被加固以帮助防止撕裂。例如,图9C 显示小叶一角的放大图,其中在放大图中,狭槽周围的区域有加固条 87。条87可以是生物假体组织的附加层,或如涤纶的织物的区段。替选地,狭槽86可以终止于圆形孔以紧密符合在线形结构74周围并减少高应力点,以及具有加固条87。另一种可能性是留下小叶72的在狭槽86周围比剩下的小叶更厚的一部分,例如通过从心包囊的具体区域切割小叶,或将剩下的小叶变薄。
还应当注意,凸起78之间的小叶自由边缘76的长度被设计用来促进小叶的全开放。如果R是在线形结构的合缝位置处的线形结构半径,那么小叶自由边缘76的长度等于至少约2πR/3。
图9A示出在其关闭位置的小叶72,其中自由边缘76向内弯使得其中点基本沿着通过瓣膜的中心流动轴线,并与其他两个小叶接合。图10A示出小叶72在线形结构74上面向内延伸。相反,图9B示出在张开配置中的小叶72,其中通过流动孔口的血液流动82由向上箭头表示。正如图10B能够看出,通过消除由从线形结构74向内突出的小叶72导致的对流动的任何障碍,把小叶72的外边缘设置在线形结构 74的顶部上面最大化有效孔口面积。图10C示出现有技术中附接在线形结构74下面的小叶84,并且也示出把小叶72附接在线形结构上面的新布置。在两个小叶72、84之间的区域指示在其中流动可能被“线形结构下的”小叶限制的区域。
除了如上在74处所示的单线材线形结构外,本申请还涉及一种双线材线形结构的“夹层”配置,如图11-12所示。更具体地,在人工心脏瓣膜90相对于外部线形结构94和内部线形结构96的线形结构组件的取向上再次由单个小叶92表示。再次,线形结构94、96两者都以具有尖瓣和合缝的波状形态围绕心脏瓣膜外围延伸。
内部线形结构96的整体外形比外部线形结构94在半径上更小,并且在轴向尺寸上更短。然而,在合缝区域处,内部线形结构96向外弯曲使得其径向处于外部线形结构94的外侧来充当小叶凸起98的缝合锚。换句话说,内部线形结构96的合缝代替如在现有技术中的支架结构的合缝柱。相邻的小叶凸起98缠绕在内部线形结构96周围并被缝在一起。内部线形结构96在尖瓣区域处的OD应该等于瓣膜的尺寸。换句话说,每个瓣膜有确定的尺寸,通常从19毫米到29毫米在奇数上具有2毫米的增量。内部线形结构96因此在其尖瓣处针对尺寸19 毫米的瓣膜来说具有大约19毫米的直径等等。因此,内部线形结构96 有助于维持与内部线形结构的圆形开口区域一样大的小叶开口区域。
外部线形结构94遵循类似于现有技术中现有线形结构的轮廓外形,尽管它具有较大直径。小叶92在腹部区域内被夹在两个线形结构 94、96之间。小叶92包裹在内部线形结构96上方并且然后在使得小叶腹部保持就位的外部线形结构94之下。因此,在腹部区域(尖瓣的中心)中内部和外部线形结构94、96之间的间隙近似等于小叶92的厚度。在合缝区域中,小叶凸起98在外部线形结构94的倒U形的合缝底部穿过,其因此将小叶凸起保持在一起以便当关闭时三个小叶保持这种接合。小叶腹部边缘能够插在外部线形结构下面并且然后通常利用缝合环(未示出)缝合在一起。虽然缝合环被用在常规心脏瓣膜中,但是由于各种原因一些较新的配置忽略了缝合环。例如,某些心脏瓣膜通过诸如夹具、支架或倒钩等自包含结构附接到环,或者以其他方式附接而(根本)不利用缝线,这是缝合环的主要目的。另外,软环可被提供在瓣膜周围以相对于周边环密封并防止瓣膜周围的泄漏,但是该软环不是常规的缝合环在于,它不与缝线一起用作基本锚定结构。
两个线形结构组件具有多种用途。内部线形结构96的尖瓣区域保持与来自现有技术瓣膜的现有线形结构相同轮廓外形和相同圆形开口直径。由于小叶在腹部区域中靠在内部线形结构的顶部,因此内部线形结构96有助于维持最大开口轮廓。同时,外部线形结构94保持小叶腹部就位并将小叶凸起98维持在一起,以增强接合。此外,内部线形结构96在合缝处向外弯曲,以提供用于小叶凸起98的附接结构,从而消除针对在现有技术瓣膜中的支架结构的一个目标。确实,整个瓣膜可包括两个覆盖有织物并缝合至小叶92的线形结构94,96和固定在线形结构组件外周周围的缝合可渗透缝合环100(参见图12A)。再次,所述缝合环在此仅作为示例示出,并且可代表密封环或可被完全消除。
图12A示出示例性构造,在该构造中小叶92的外边缘卷绕在外部线形结构94周围并且缝合环100被固定在其周围。线形结构94、96 每个将被覆盖有织物,尽管为了清楚已被省略。线形结构94、96周围的织物可被缝合到缝合环100,其典型地包括由织物104包围的内部硅胶芯102。图12A示出瓣膜和其闭合位置,其中流体回流引起小叶92 移动到流动孔口的中间且与其他小叶接合。
在另一方面,图11B和图12B示出在张开配置中的小叶,其中示出血液流动106。因为小叶92在内部线形结构96的顶部上面延伸,它不存在对血液流动的阻碍并且因此最大化有效孔口面积。图12C再次示出在瓣膜的开口配置中附接在内部线形结构96下面的小叶108的位置。在线形结构96上面延伸的处于小叶108和小叶92之间的区域110 是孔口流动面积的差,其通过使用本瓣膜构造获得。
图13是如图11A和图11B中利用在合缝区域处相互交叉的双线形结构94、96所组装的心脏瓣膜的透视图。外部线形结构94总是可观察到的,并且内部线形结构96除了在合缝末端处由小叶覆盖,所述合缝末端弯曲到外部线形结构外侧。小叶92的凸起在合缝柱处被夹在外部线形结构94和内部线形结构96之间。在优选的实施例中,小叶92的凸起包裹在内部线形结构96周围,因为整个组件覆盖有织物,未示出该凸起。
另一种可替代的人工心脏瓣膜120被示于图14。如同第一环境中,存在每个小叶124的尖瓣边缘附接在其上方的单线材线形结构122。小叶凸起126包裹在支架合缝柱128周围,该凸起向外弯曲并且然后通常再次轴向弯曲以为合缝夹片130制造空间。夹片130有助于保持良好的小叶接合,并且为了更好的耐用性降低了在小叶中的应力。再次,由于每个小叶124在线形结构122的顶部上面延伸,最大化有效孔口面积。尽管未示出,线形结构122周围的织物覆盖和夹片130被缝合在一起以固定组件。夹片130被示出为闭合椭圆形,虽然其它配置是可能的。
图15是具有固定在其中的小叶142的双线形结构人工心脏瓣膜 140的子组件。外部织物覆盖的线形结构144附接在内部织物覆盖的线形结构146下面。虽然未示出,缝合环可附接在线形结构144、146尖瓣部分周围,其中在线形结构的合缝部分处的间隙填充防止泄漏的织物或其它此类材料。
图15的双线形结构瓣膜140可被组装,如图16看出。更具体地,外部或更大织物覆盖的线形结构144附接在内部织物覆盖的线形结构 146的下面或周围。优选地,如图所示,柔性小叶142预先附接到内部线形结构146。外部线形结构144可直接对齐内部线形结构146的下方,或者可以在径向上稍微更大。
如图17A至图17C中所示,线形结构144、146的横截面可以是圆形或正方形,或具有另一种多边形形状。具有正方形或矩形横截面的线形结构可锁在一起或相比具有圆形横截面的线形结构更好地保持轴向对齐。应当注意,内部和外部线形结构144、146两者的线材直径能够是相同的或不同的,以便改变弹簧劲度系数、合缝偏转率和瓣膜功能。
在优选的实施例中,用于这里所公开的任何瓣膜的线形结构都是钴-铬-镍合金,例如埃尔基洛伊耐蚀游丝合金(Elgiloy)。然而,线形结构能够由任何半刚性的(意味着不软)金属或具有足够弹性以保持其用于递送的形状的聚合物材料形成并且移植物还能够具有挠性以在植入后由于天然收缩-舒张力而低度弯曲。埃尔基洛伊耐蚀游丝合金、不锈钢、钛以及镍钛诺都是可能的金属材料,并且各种聚酯或尼龙合成材料是备选。
如图17A至图17C所示,附接到外部线形结构144的织物凸起150 延伸超出附接到内部线形结构146的织物凸起152。一小片硅胶管或带 154至少在线形结构144的尖瓣处可被添加到较大织物凸起150,以为针穿透提供缝合环或种类(sorts)以及较大的目标。小叶142夹在两个线形结构144、146之间,并且通过相邻的织物凸起150、152被缝合至该线形结构。应当注意,线形结构144、146的横截面形状以各种方式示出从而强调可能的组合:两者皆圆形;一个正方形和一个圆形等。
在示例性的实施过程中,瓣膜140将利用外部线形结构144的较大织物凸起150直接附接到主动脉壁。所述凸起150能够如图18A所示向下弯曲,或如图18B所示向上弯曲。织物凸起150向上和向下延伸线形结构144、146,并且因此遵照主动脉壁的自然扇形形状。尽管未示出,但在合缝处的小叶142附接可被配置为与本文所公开的任何其他双线形结构瓣膜相同,例如通过径向向外弯曲内部线形结构146 并围绕它包裹小叶凸起。
由图15至图18的双线形结构组件所提供的高度柔性瓣膜相对于当前市场上具有相对刚性的环形框架的主动脉瓣瓣膜大大改善了血液动力学。在主动脉处上下合缝的附接最大化能够植入的瓣膜的尺寸。还预计因为由线形结构从上方和下方支撑小叶,所以此瓣膜相比当前所生产的那些瓣膜具有相似的耐久性。此外,瓣膜140还实现比当前制造的瓣膜显著的成本节省。如图16中所示的相对简单的双线形结构的组件替换典型地需要有许多织物覆盖部件的劳动密集型的拼接。
此外,图15的双线形结构瓣膜140消除心脏瓣膜的任何刚性环形部件,这是在商业瓣膜中相当标准的构造。因此,线形结构144、146 的三个尖瓣部分是相对自由的以利用周围的环和升主动脉膨胀和收缩,从而改善血液动力学。此外,双线形结构瓣膜140的高度柔性性质有利于后续瓣膜间的过程。随着时间的推移,人工心脏瓣膜可经受例如来自钙化的降低的性能,因此需要更换。可用的一种技术是将可膨胀瓣膜直接植入在现有人工瓣膜内。然而,现有手术上的瓣膜通常具有刚性环形内部框架或支架,以使第二瓣膜不能膨胀至相同的孔口直径。然而,在高度柔性双线形结构瓣膜140中,随后所植入的瓣膜能够像气球一样膨胀并迫使第一瓣膜打开。尖瓣区域由向外的力分开,并且新瓣膜将随后膨胀到合适的直径,而不牺牲来自瓣膜间过程的任何流动体积。
图19A和图19B示出用于可替代双线形结构人工心脏瓣膜的上部和下部线形结构160、162。上部线形结构160具有如上所述的那些大致相同的配置且具有交替的弧形尖瓣164和倒U形的合缝166。在另一方面,下部线形结构162使用三个弧形的谷170和三个直立的峰172 被截断,其中三个弧形的谷170匹配上部线形结构尖瓣164的形状,三个直立的峰172仅部分地延伸到上部线形结构合缝166。在一个实施例中,在峰172处下部线形结构162的高度是在合缝166处上部线形结构160的高度约一半。图19B中所示的所组装的线形结构示出了通常不由下部线形结构162支撑的上部线形结构合缝166。柔性小叶180 由上部和下部线形结构160、162组合支撑,并示意性地示出,而无需连接结构仅仅是为了指示其放置。如将解释的,上部和下部线形结构 160、162两者通常都覆盖有织物,以方便其利用缝线等附接至彼此且附接至小叶180。
以如图15的版本中类似的方式,缝合环(未示出)可附接在线形结构160、162的尖瓣部分周围,其中在合缝区域处间隙填充防止泄漏的织物或其它此类材料。例如,可使用如图18A和图18B中所示的诸如织物凸起150的缝合环。柔性小叶180的外周边缘至少在尖瓣区域内期望地被夹在两个线形结构160、162之间,很像上述关于图17A至图17C所描述的那样。
图20A和图20B示出了所组装心脏瓣膜的合缝柱区域,其中示出把柔性小叶180附接到上部线形结构合缝166的方式。具体地,沿上部线形结构160的长度延伸的织物(聚酯织物)覆盖182包括在合缝 166的上部区域处的凸起扩展部184,小叶凸起186被缝合到凸起扩展部。小叶凸起186在合缝166的间隔线材之间和织物凸起扩展部184 之间径向向外突出。图20A示出部分组件从而使连接清楚,并且织物凸起扩展部184和小叶凸起186的组合凸起优选被卷起或折叠并且利用缝线188缝合成如图20B中所示的合缝166外侧的束190。所述束190比合缝166的间隔线材之间的间隙大,并且因此小叶凸起186被固定至合缝166并且由于束状的配置具有施加到连接缝线188的小应力。可选地,较硬的织物或聚合物的小插入物(未示出)可被卷起到束190 内用于保持所述束在合缝166外侧上的附加体积。
尽管本发明已在其优选实施例中进行描述,但应当理解,已被使用的词语是描述性的词语而不是限制性的词语。因此,在所附权利要求内且不脱离本发明的真正范围的情况下可作出改变。
Claims (5)
1.一种人工心脏瓣膜,其包括:
第一织物覆盖的波状线形结构,其具有交替的尖瓣和围绕外围的合缝;
第二织物覆盖的波状线形结构,其具有交替的尖瓣和围绕外围的合缝,两个线形结构的所述尖瓣和合缝彼此对准;以及
具有外边缘的多个柔性小叶,所述外边缘夹在所述第一织物覆盖的波状线形结构的所述尖瓣和所述第二织物覆盖的波状线形结构的所述尖瓣之间,
其中所述第一织物覆盖的波状线形结构和所述第二织物覆盖的波状线形结构中的每个独立地包括半刚性金属材料,
其中所述第一线形结构的合缝仅向上部分地延伸到所述第二线形结构的合缝,并且
其中所述第一线形结构的半径比所述第二线形结构的半径稍小,所述第二线形结构除在所对齐的合缝处以外从所述第一线形结构向外布置,其中所述第一线形结构在所述对齐的合缝处向外弯曲使得其合缝径向地在所述第二线形结构之外并提供用于所述柔性小叶的合缝凸起的缝合锚。
2.根据权利要求1所述的心脏瓣膜,其中所述线形结构中的一个上的织物凸起至少在所述线形结构中的所述一个的所述尖瓣处包围一小片硅胶带以提供缝合环。
3.根据权利要求1所述的心脏瓣膜,其中所述柔性小叶具有夹在所述第一织物覆盖的波状线形结构的所述合缝和所述第二织物覆盖的波状线形结构的所述合缝之间的合缝边缘。
4.根据权利要求1所述的心脏瓣膜,其中所述柔性小叶中的每个都具有被夹在所述第一线形结构和第二线形结构之间在所述对齐的合缝处的凸起。
5.根据权利要求4所述的心脏瓣膜,其中所述柔性小叶的所述凸起环绕所述第一线形结构并在所述对齐的合缝处附接至所述第一线形结构。
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- 2014-09-17 WO PCT/US2014/056070 patent/WO2015042135A1/en active Application Filing
- 2014-09-17 US US14/488,728 patent/US10441415B2/en active Active
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EP3046512A1 (en) | 2016-07-27 |
CA2910602A1 (en) | 2015-03-26 |
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WO2015042135A1 (en) | 2015-03-26 |
US10441415B2 (en) | 2019-10-15 |
US20150088250A1 (en) | 2015-03-26 |
SG11201508895RA (en) | 2015-11-27 |
CA2910602C (en) | 2020-03-10 |
CN105263445A (zh) | 2016-01-20 |
EP3046512A4 (en) | 2017-09-06 |
US11266499B2 (en) | 2022-03-08 |
EP3046512B1 (en) | 2024-03-06 |
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