CN108135699A - 受限扩张心脏瓣膜 - Google Patents
受限扩张心脏瓣膜 Download PDFInfo
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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
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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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
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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Abstract
公开了人工心脏瓣膜连同使用其的方法,所述人工心脏瓣膜配置为置换天然心脏瓣膜并且具有支撑框架,所述支撑框架配置为被再成形为扩张的形式,以便在其中接收和/或支撑可扩张的人工心脏瓣膜。包括互锁构件或挠性环路以将瓣膜的扩张限制于一种或两种瓣膜大小,例如,在每种瓣膜大小之间存在2‑mm差距。瓣膜可以包括具有重叠的自由端的内部结构带,其具有用于限制扩张的结构,或缝线外部环路可以被添加至限制扩张的织物覆盖物。
Description
本公开内容涉及用于心脏瓣膜置换的心脏瓣膜,并且更具体地涉及对外科心脏瓣膜的构造进行改造以使得能够在其中接收可扩张的人工心脏瓣膜和使其以受限程度扩张。
心脏是中空的肌肉器官,其具有四个泵送室(pumping chamber),所述四个泵送室被四个心脏瓣膜隔开:主动脉瓣、二尖瓣(或僧帽瓣)、三尖瓣和肺动脉瓣。每个心脏瓣膜由被称为环(annulus)的致密纤维圈(ring)和附接至环的小叶或尖突组成。
心脏瓣膜疾病是广泛的病症,其中心脏瓣膜中的一个或多个不能正常地起作用。在传统的瓣膜置换手术中,通常切除受损的小叶,并且将环塑形(sculpt)以接收置换人工瓣膜。
在组织型瓣膜中,完整的异种移植瓣膜(例如,猪的)或多个异种移植小叶(例如,牛心包)可以提供流体闭塞表面。已经提出了合成小叶,并且因而术语“挠性小叶瓣膜”指的是天然和人工“组织型”瓣膜二者。在典型的外科心脏瓣膜中,两个或更多个挠性小叶被安装在外围支撑结构内,该外围支撑结构通常包括在流出方向中延伸的支柱或连合以模拟天然环中的天然纤维连合。金属或聚合物“支撑框架”,有时被称为“线型件(wireform)”或“支架”,具有多个(通常三个)大半径尖突,其支撑挠性小叶(例如,完整的异种移植瓣膜或三个单独的小叶)的尖突区域。每对相邻的尖突的端部略微渐近地汇合以形成以尖端终止的直立的连合,其每个在与弓形尖突相反的方向中延伸并且具有相对较小的半径。经常将瓣膜的部件与一种或多种生物相容性织物(例如,聚对苯二甲酸乙二酯)覆盖物组装,并且在外围支撑结构的流入端上提供织物覆盖的缝合圈。
有时,在患者已经进行较早的瓣膜置换后,可能出现对完整的瓣膜置换的需要。例如,被成功地植入以置换天然瓣膜的人工外科心脏瓣膜在最初被植入后许多年自身可能遭受损害和/或磨损和撕裂。直接在先前植入的人工心脏瓣膜内植入新的人工心脏瓣膜(所谓的瓣中瓣(valve-in-valve)手术)可能是不切实际的,这是由于传统的人工外科心脏瓣膜可能没有被配置为以如下方式容易地接收这样的瓣内瓣(valve-within-valve)植入:其为新瓣膜提供稳固的基座(seating),同时还在新瓣膜内具有足够大的环以支撑通过其的适当血液流动。即,当起单向(one-way)瓣膜作用时,常规的外科瓣膜具有相对稳定的直径,所述直径不意欲在递送期间和在植入后被压缩或扩张。
已经对在旧瓣膜内植入新瓣膜的问题予以一些关注。具体而言,下列公开了用于瓣中瓣系统的多种方案:2011年7月7日提交的美国专利号8,613,765;2008年9月19日提交的美国专利号9,314,335;2013年12月20日提交的美国专利号9,364,322;2013年12月20日提交的美国专利号9,375,310;和2011年8月2日提交的国际专利公布号WO 2012/018779。这些出版物的整个公开内容通过引用明确地并入本文。
尽管在瓣中瓣领域中取得了某些进步,但是对促进瓣中瓣手术并且简化制造技术的人工心脏瓣膜仍然存在需要。
一些实施方式提供了人工外科心脏瓣膜,其配置为在其中接收第二人工心脏瓣膜,比如导管部署(经导管)的人工心脏瓣膜。外科心脏瓣膜适合于植入后扩张和防止过度扩张的扩张限制器。
本申请提供了适合植入后扩张的人工外科心脏瓣膜的大量实施方式,其每个限定了流入端和流出端并且包括瓣膜构件,所述瓣膜构件包括不可塌缩的内部结构支撑支架,其具有在流出方向中延伸和围绕支撑支架的外围均匀地间隔的三个直立的连合支柱,它们与相邻的连合支柱之间中途的三个弓形的流入尖突交替。三个挠性小叶沿着支撑支架的连合支柱和流入尖突附接并且被配置为确保通过瓣膜构件的单向血液流动。支撑支架外围限定了不可塌缩的递送和具有第一直径的植入物圆周,其中在从支撑支架内施加向外的膨胀力——其大幅大于与正常的生理学用途相关联的力——之后,支撑支架允许外围从第一直径扩张至大于第一直径的第二直径。支撑支架包括围绕外围延伸的结构带,其允许支撑支架的扩张。
在第一实施方式中,结构带具有重叠的自由端,以便重叠的自由端的相对滑动允许支撑支架的扩张,并且瓣膜构件包括介于重叠的自由端之间的扩张限制隔离物,其接合两个自由端并且防止支架过度扩张超过第二直径。期望地,重叠的自由端在支撑支架的流入尖突中的单独一个处定位。扩张限制隔离物可以具有两个指状物(finger),其在相反的方向中径向地偏移并且延伸通过在各自的结构带自由端中提供的通道。指状物优选地终止于比通道更宽的增大的头部。扩张限制隔离物优选地由选自聚酯、聚四氟乙烯(PTFE)、超高分子量聚乙烯(UHMWPE)和聚醚醚酮(PEEK)的润滑材料制成。
在第二可选实施方式中,结构带也具有重叠的自由端,以便重叠的自由端的相对滑动允许支撑支架的扩张,并且一个或多个长丝的环路(loop)通过结构带中的孔——与每个自由端相邻——被宽松地穿过,以便环路中的松弛(slack)允许结构带扩张但是防止支架过度扩张超过第二直径。环路优选地包括通过孔穿过至少三次并且在带的外侧上打结的单个缝线。环路中的松弛可以位于带外侧,并且当支撑支架以布料覆盖时环路和松弛被隐藏。期望地,重叠的自由端在支撑支架的流入尖突中的单独一个处定位。
在第三可选实施方式中,瓣膜构件具有外部织物覆盖物和缝合至织物覆盖物的具有高拉伸强度的扩张限制挠性环路,其允许支撑支架从第一直径扩张至第二直径并且防止支架过度扩张超过第二直径。挠性环路期望地由高拉伸强度纤维制成。挠性环路可以被缝合至环绕支撑支架的流入尖突的瓣膜的缝线可透过的缝合圈的外边缘,缝合圈是可压缩的,以便于允许支撑支架从第一直径扩张至第二直径直到挠性环路变得紧绷并且限制进一步的扩张。挠性环路可以使用间断的针脚围绕缝合圈被附接或在两个自由端打结在一起的情况下在缝合圈内外缝合。可选地,挠性环路直接围绕支撑支架被缝合至织物覆盖物的一部分,并且并入松弛段,其允许支撑支架从第一直径扩张至第二直径直到挠性环路变得紧绷并且限制进一步的扩张。结构带可以具有重叠的自由端,以便重叠的自由端的相对滑动允许支撑支架的扩张。重叠的自由端期望地在支撑支架的流入尖突中的单独一个处定位。
在具有结构带——其具有重叠的自由端——的任何外科心脏瓣膜中,挠性套筒可以进一步环绕自由端并且将它们径向地保持在一起。在一个实施方式中,套筒由选自聚酯收缩包装管材和硅橡胶的材料制成。而且,套筒可以是可生物降解的,以在植入后维持两个自由端的对齐持续一段时间,并且然后降解以允许带甚至更容易的扩张。
任何外科心脏瓣膜可以进一步包括在植入后从主体外侧可见的支撑支架上独特的标识物,其将支撑支架标识为是可扩张的。任何心脏瓣膜的支撑支架可以包括针对连合带——其限定支撑支架的三个直立的连合支柱——同心布置的结构带,结构带在连合带的连合支柱处是截短的。结构带期望地由金属制成并且连合带期望地由聚合物制成。
根据下列详细描述,连同图解——举例而言——某些原理和实例的附图,其它特征和优势将变得明显。
图1A-1D是具有内部结构带的现有技术的示例性人工心脏瓣膜的透视图和分解视图;
图2A和2B是可以被用于多种人工心脏瓣膜以使得其能够植入后扩张的结构带的示例性组合的第一带的透视图和正视图;
图3A和3B是第二带的透视图和正视图,该第二带可以与图2A和2B的第一带结合以形成用于多种人工心脏瓣膜以使得其能够植入后扩张的结构带的组合;
图4是使得人工心脏瓣膜能够植入后扩张的图2和3中的结构带的组合的透视图;
图5A-5C是具有受限扩张能力的示例性心脏瓣膜带构型的未扩张视图、扩张视图和俯视图;
图6A-6C是用于图5A-5C的带构型的示例性锁紧片(locking tab)的透视图和正交视图;
图7A是用于心脏瓣膜的具有受限扩张能力的进一步带的透视图,并且图7B和7C是处于未扩张和扩张状态的带的重叠自由端的放大视图;
图8-10是具有用于限制瓣膜的总体扩张的外围缝线的人工心脏瓣膜的透视图;和
图11是通过比如图8-10中的人工心脏瓣膜的尖突边缘的径向剖视图,其显示了用于放置扩张限制缝线的多种位置。
本文公开的人工心脏瓣膜包括与常规的外科瓣膜的实施方式类似构造的人工瓣膜构件,当起单向瓣膜作用时,其具有相对稳定的直径,所述直径不意欲在递送期间和在植入后被压缩或扩张。本文描述的人工心脏瓣膜每个包括内部(意思是并入瓣膜构件自身,与成为补充元件相反)结构支架或框架,其通常是管的形状并且限定血液通过其从流入端流动至流出端的流动孔口区域。可选地,内部支架的形状可以是卵形、椭圆形、D形、不规则或任何其它期望的形状。瓣膜包括选择性地开启和闭合以允许通过其的单向流体流动的挠性小叶。
本文公开的多种内部支架具有“可扩张的区段”,其使得支架能够扩张。扩张的实施方式可以从破裂、塑性拉伸或弹性伸长的可扩张的区段发生。因而,“可扩张的区段”意思是使得它能够在直径上扩大的支架上的位置,比如当球囊在支架内膨胀时。实例包括可能破裂的薄弱点、破裂或拉伸的变薄区域,弹性或塑性伸长的手风琴样结构,与可破碎构件比如缝线或点焊缝保持在一起的支架中的断裂处(break),和多种其它手段。术语“可扩张的区段”因而涵盖——单独地或组合地——这些替代方案中的每一种。
本申请公开了对现有的外科瓣膜的具体改造,其使得制造商能够快速地生产适应瓣中瓣(ViV)手术的瓣膜。具体地,本申请考虑改型或改造现有的外科瓣膜内的部件以使得能够植入后扩张,其不仅转变任何经验证的外科瓣膜用于ViV手术,而且还减少设计和制造工作。因此,下面描述了一种普及的外科瓣膜的部件以说明对其的某些改造。
近来的出版物报道了当在天然环中扩张人工心脏瓣膜时,当扩张天然环超过按面积计20%时,环破裂的可能性显著更高。鉴于此信息,在一些实施方式中,期望确保可扩张的外科瓣膜扩张小于大约按面积计20%。对于19-mm瓣膜,20%的面积增加相当于大约2mm的直径增加。
图1A-1D是围绕流动轴线22取向的示例性外科人工心脏瓣膜20的透视图和分解视图。心脏瓣膜20包括多个(通常三个)挠性小叶24,其部分地由波状线型件26以及由不可塌缩的内部结构支撑支架28支撑。线型件26和支撑支架28在附图中是可见的,但是正常地覆盖有聚酯织物以促进组装和在植入后减少直接的血液暴露。线型件26可以由合适的弹性金属形成,比如Co-Cr-Ni合金如合金,而支撑支架28可以是金属的、塑料的或两者的组合。如图1B中可见,相邻的小叶24的外部片(tab)30围绕支撑支架28的部分在瓣膜的所谓的连合支柱——其沿着流动轴线22在流出方向中伸出——处缠绕。软密封或缝合圈32局限人工心脏瓣膜20的流入端并且通常被用于将瓣膜固定至天然环,比如使用缝线。
图1C和1D以组装和分解视图二者显示了内部支撑支架28。虽然如图1A和1B中可见的人工心脏瓣膜20的一般特性可能对大量不同的人工心脏瓣膜是共有的,但是图解的支撑支架28是用于特定的心脏瓣膜的那种;即,由Irvine,CA的Edwards Lifesciences制造的心包心脏瓣膜。例如,利用心包小叶24的Carpentier-Edwards 心脏瓣膜以非常像图1C和1D中显示的内部支架28为特征。具体而言,支架28包括两个同心带的组件或复合零件:外部带34环绕内部带35。带34、35的径向尺寸与轴向尺寸相比是相对薄的,并且两者具有围绕圆周轴向地上下起伏的一致的下边缘。外部带34展示了在三个向下弯曲的谷之间的三个截短的峰,而内部带35具有大体上相同的形状而且在连合支柱36处向上延伸。向下弯曲的谷通常被称为尖突38,如图1C中可见的。此波状带形状对于主动脉心脏瓣膜是典型的,其通常具有在直立连合处、在它们相邻的边缘处连接的三个小叶。可选地,结构支架可以具有具备连合支柱的仅一个带。
在示例性瓣膜中,外部带34是金属的并且由闭合为大体上圆形形状和端部如在40处连接在一起——例如通过焊接——的细长的金属条带形成。相比之下,内部带35由生物相容性聚合物比如聚酯(例如,聚对苯二甲酸乙二酯(PET))或聚缩醛(例如,聚缩醛)形成,其可以被模塑,并且也可以形成为条带,闭合为圆形形状和端部连接在一起,例如,通过焊接(未显示)。外部和内部带34、35二者以一系列通孔为特征,所述通孔彼此对准(register),使得组件可以被缝合在一起,如图1C中在连合区域处示意性图解的。线型件26和内部带35的连合支柱36给瓣膜的连合提供挠性,其帮助降低小叶24的生物假体材料上的应力。然而,由缝合圈32环绕的瓣膜20的流入端或基底包括支撑支架28的相对刚性的圆形部分。金属外部带34和塑料内部带35的组合给瓣膜赋予相对尺寸稳定的圆周基底,其有利于典型的外科用途。然而,给外科瓣膜提供良好稳定性的支撑支架28的相同特性抵抗瓣膜的植入后扩张。因此,本申请考虑对支撑支架28的各种改造以促进其扩张。
以上描述的示例性外科瓣膜20可以因而被改造用于植入后扩张。此外,类似的外科瓣膜结构被用于商业化Edwards 瓣膜系统,并且可以在该系统的瓣膜部件中进行相同的改造,使得它可以在植入后容易地扩张。
图2A和2B是第一带50的透视图和正视图,所述第一带50用于结构带的示例性组合以置换现有的支撑带和使得其能够植入后扩张。第一带50再次具有相对于其轴向高度相对小的径向厚度,并且包括波状环形状,其在向上伸出的连合支柱54中间具有向下弯曲的尖突52。在优选的实施方式中,第一带50包括开始为平的条带的聚合物材料,其然后被弯曲为圆形形状并且两个自由端如在56处连接在一起,例如,焊接。
第一带50包括位于连合支柱54中的每个下方的弱化区域,其使得带能够破裂并且容易连同人工心脏瓣膜的其余部分扩张。第一带50包括在连合支柱54中的每个处的一系列垂直间隔的通孔60、62。具体而言,第一对通孔60紧密相邻带的下边缘64定位。通过带50的厚度的垂直划线66从第一对通孔60的正上方垂直向上延伸至上部通孔62,其在连合支柱54中途附近定位。优选地,划线66与上部通孔62连通。通孔60、62可以是如显示的圆形的,或可以是略微细长的比如以泪珠形状,以便于将由带50的扩张生成的任何张力集中至某点,比如垂直向上的,或通孔60、62可以具有任何其它合适的形状,例如,菱形的、三角形的、椭圆形的。由于相对薄弱的聚合物材料以及由通孔60、62和划线66提供的弱化区域,第一带50倾向于在连合支柱54下方的三个位置处分裂开。如上面说明的,挠性小叶经常被固定至连合支柱54的上端,其在上部通孔62上方保持基本上不变。虽然其中组装第一带50的人工心脏瓣膜被第二瓣膜所替换,但是期望维持瓣膜的总体完整性以避免任何松散的部件。
图3A和3B是第二带70的透视图和正视图,所述第二带70可以与图2A和2B的第一带50结合以形成复合结构带,用于多种人工心脏瓣膜以使得其能够植入后扩张。具体而言,当在心脏瓣膜中组装时,第二带70与第一带50密切接触围绕其同心地定位,如图4中可见的。第二带70也具有波状环形状,其中下部-弓形尖突区域72与向上延伸的连合区域74交替。两个带的主要不同在于第二带70的连合区域74是截短的,其仅向上延伸第一带50的连合支柱54的部分。
第二带70期望是金属的,比如钴-铬合金,例如,Co-Cr-Ni合金例如,合金(Elgiloy Specialty Metals,Elgin,IL),并且优选地最初形成为平的带,其被环化为环形状。在图解的实施方式中,带70的两个自由端76a、76b彼此重叠和接合,以便受限扩张。这样的接合的优选实例显示在图3B和5A-5C中。因为第一带50包括聚合物材料和第二带70是金属的,所以第二带可以被称为“结构带”,这是由于它给由二者的组件形成的支撑支架和其中使用支撑支架的人工瓣膜的任何尺寸改变提供更大的抗性。第一带50可以被称为“连合支柱带”,这是因为它提供了瓣膜小叶附接至其的连合支柱54。还应当理解这两个同心带可以被组合为具有连合支柱和在尖突区域处期望地提供的两个自由端的一个结构带。
如图5A-5C中可见,此实例中的两个自由端76a、76b被滑动插入物或“隔离物”78径向地隔开,在图6A-6C中更详细地显示。例如,隔离物78由润滑材料比如聚酯、聚四氟乙烯(PTFE)、超高分子量聚乙烯(UHMWPE)形成。隔离物78主要形成为径向薄的矩形主体80,其具有与两个自由端76a、76b的曲率相同或类似的曲率。具有增大片82的一对偏移互锁指状物81由主体80切割并且在主体80的任何一个径向侧上伸出,如图6A和6C中可见的。指状物81在主体80的中间附近开始,远离彼此伸出并且远离主体的相对侧径向地成角度。每个指状物81是大体上矩形的并且以增大片82——其也被图解为矩形的——终止。隔离物78期望地由大约0.1mm(大约0.004")厚的聚酯(例如,PET)制成并且进行模切,或可以根据需要由其它更坚固的材料比如聚醚醚酮(PEEK)切割或模塑。隔离物还可以是复合零件,例如,包括更坚固的中心层和润滑的外层。
两个自由端76a、76b每个在一对凸肩(shoulder)84——其减小具有中心圆周开槽87的中间部分86的轴向高度——处区别于带的其余部分。每个自由端76a、76b终止于轴向增大的头部88(或相反定向的轴向隆起物(bump)),其具有与带70的大部分近似相同或与带的两个不可扩张的尖突区域相同的轴向高度。滑动隔离物78上的指状物81延伸通过各自自由端76a、76b上的圆周开槽87,如图5B和5C中最佳可见的。
图5A中可见的两个自由端76a、76b和隔离物78的组件被挠性套筒89——其环绕自由端76a、76b并且将它们径向地保持在一起——保持在一起。套筒89期望地包括聚酯(例如,PET)收缩包装管材,或可以是弹性材料,比如硅橡胶,并且显示是透明的以图解配对的自由端76a、76b。两个自由端76a、76b可以在保持重叠的同时滑动分开预定的距离。挠性套筒89针对轴向增大的头部88提供了少量或最小量的摩擦,并且通常用于维持自由端76a、76b的对齐。
第一带50与第二带70密切接触的组件,如图4中可见的,当使用时给人工瓣膜小叶提供了良好的稳定性,以及提供有利的可扩张的结构,如果或当必需瓣中瓣手术时。挠性套筒89标称地维持带的直径,使得它在制造期间是稳定的,但是当进行瓣中瓣手术时允许它容易地打开或扩张。而且,当期望时,套筒89可以是可生物降解的,以在植入后维持两个自由端76a、76b的对齐持续一段时间,并且然后降解以允许带70的甚至更容易的扩张。
当在心脏瓣膜内施加膨胀力比如扩张球囊时,自由端76a、76b滑动分开并且位于连合支柱54中的每个下方的第一带50上的弱化区域中的一个或多个破裂,使得瓣膜的主要圆形支撑物扩张。瓣膜的线型件26或其它结构容易地折曲分开。优选金属外部带70仅在一个位置处扩张,而优选聚合物带50可以在所有三个连合处扩张。外部带70能够在周围布料覆盖物内并且相对于其它部件滑动,以便瓣膜围绕其周长大体上均匀地扩张。即,小叶附接至的线型件的连合区域和金属带70的连合区域最初被对齐或对准。随着金属带70扩张,对准的连合区域变得非对齐,这是由于线型件26在所有三个连合处扩张并且金属带仅在一个尖突处扩张。然而,该瓣膜变得陈旧,已经被置换为经导管瓣膜,并且由此这个非对齐无足轻重。线型件与在当它们有功能时大致相同的位置中维持扩张瓣膜的直立的连合支柱,其在周围的冠状动脉口中间,并且因而瓣膜扩张将不结束于阻塞到冠状动脉的关键血液流动。
滑动隔离物78上的互锁指状物81和自由端76a、76b上的圆周开槽87之间的干涉限制带70的整体扩张。图5A显示了处于其未扩张构型的带,其中自由端76a、76b几乎完全地重叠。图5B显示了分离的自由端76a、76b,比如如果膨胀装置例如球囊在ViV手术中在人工心脏瓣膜内扩张的话。指状物81上增大片82中的每个保留在相关联的圆周开槽87的各自侧上,其最终防止自由端76a、76b完全地分离。因此,滑动隔离物限制带70的整体扩张,比如限制于预定量,例如,大约2mm。互锁指状物81和开槽87的几何结构可以被设定尺寸以将带70和瓣膜的扩张限制于一种或两种瓣膜大小,例如,在每个瓣膜大小之间具有2mm。
具有与自由端76a、76b二者互锁的指状物81的滑动隔离物78的具体构型仅仅是示例性的并且可以采用其它形式。例如,增大片82可以被不同地成形比如是正方形的或圆形的而非矩形的。进一步,有利于各自自由端76a、76b上的互锁元件,可以排除滑动隔离物78。在带是金属的一些实例中,聚合物隔离物78降低滑动摩擦和/或可能由金属对金属接触造成的可能有害的材料脱落(sloughing)。还进一步,下面显示和描述了用于限制内部瓣膜结构扩张的可选的构造。
还应当注意虽然优选地在带70的尖突区域中的一个处的自由端76a、76b处存在单个扩张点,如显示的,但是带的两个不可扩张的尖突区域也可以具有类似的扩张点。在该情况下,每个尖突区域处的总体扩张幅度将小于单个扩张点需要的,比如期望的2mm的直径增加的三分之一。进一步,提供三个扩张点将帮助减少现有的瓣膜连合的任何非对齐,该非对齐可能由在仅一个尖突处扩张而发生。
带70优选地包括使用外部成像可见和表示它可扩张的标识性状。在图4中图解的实施方式中,在每个连合区域74处提供了三个孔90的模式。另外,这允许考虑置换手术的外科医生快速地确认瓣中瓣手术是可行的。带70还可以包括使用外部成像可见的瓣膜大小指示物,比如具有瓣膜大小数目,例如,以毫米为单位的瓣膜大小,通过带的激光切割。
在图7A中显示了用于限制人工心脏瓣膜扩张的另一个想法。具体地,显示了包括结构带100的支架,所述结构带100非常像图3A的带70并且其被成形以与具有连合支柱的第二带比如图2A的带50配对。可选地,结构带100可以以连合为特征并且被成形以自身起支架作用。如之前,结构带100包括在三个连合104之间的波状模式的三个尖突102,这对主动脉心脏瓣膜是常规的。
带100是连续的,除在两个重叠的自由端106a、106b——其在尖突102中的一个的大约中间处定位——处以外。如之前的,自由端106a、106b适合关于彼此滑动并且因而允许支架在施加向外的膨胀力——比如在ViV手术中——之后扩张。在图解的实施方式中,两个自由端106a、106b被成形,略微类似上面描述的自由端76。滑动插入物或“隔离物”112被介入两个自由端106a、106b之间以降低其间的滑动摩擦。例如,隔离物112由润滑材料比如聚酯、PTFE或UHMWPE形成。两个自由端106a、106b和隔离物112的组件可以被挠性套筒(未图解)——其环绕自由端106a、106b并且将它们径向地保持在一起——保持在一起,比如上面关于套筒89所描述的。挠性套筒还针对自由端106a、106b提供了少量或最小量的摩擦。
带100的扩张被宽松地穿过带100中的孔122——与每个自由端106a、106b相邻——的一个或多个长丝的环路120限制。环路120可以包括缝线或任何其它挠性生物相容性构件。在图解的实施方式中,环路120由通过孔122穿过三次并且在带的外侧上打结的单个缝线形成。环路120中一定量的松弛允许带100在ViV手术中扩张,例如,但是扩张由此被限制。当组件以布料覆盖时环路120被隐藏,并且其松弛将优选地位于带100外侧。在心脏瓣膜扩张之后,环路120在带100的预定直径下变得紧绷以防止进一步的扩张,如图7C中显示的。例如,环路120可以被设定尺寸以将带100和瓣膜的扩张限制于大约2mm,或大约一个瓣膜大小。
虽然已经成功地测试了用于将人工心脏瓣膜的扩张限制为一种或两种大小的先前构型,但是每个需要对已有的可扩张瓣膜的设计进行改造。图8-11图解了用于限制瓣膜扩张的还进一步的变化,其通过引入可以容易地缝合入覆盖瓣膜织物的长丝的外部环路而不需要对现有瓣膜显著改造。
图8显示了非常像上面描述的典型的心脏瓣膜130,其具有由以生物相容性织物134覆盖的内部支架结构(未显示)支撑的三个挠性小叶132。在图解的实施方式中,瓣膜130具有围绕其流入端周向布置的缝合圈136。围绕缝合圈136添加挠性材料比如缝线的环路140以限制瓣膜扩张的能力。更具体地,环路140使用间断的针脚142围绕缝合圈136被附接。环路140可以由高拉伸强度纤维(例如, UHMWPE、 UHMWPE、或芳族聚酰胺)制成,并且是挠性的,使得它遵循扇贝形状轮廓并且以远离缝合圈136的内表面的距离放置或与缝合圈136的内表面间隔。距缝合圈136的内表面的距离允许来自瓣膜扩张的缝合圈的一些压缩,但是最终限制扩张的量和限定最终扩张直径。
应当理解可以跨越多种可扩张的外科瓣膜设计实施扩张限制方案,其利用附接(例如,缝合)至心脏瓣膜的外部的材料的环路,这是由于其独立于瓣膜的内部结构。即,可以在没有第二扩张限制方案的情况下在瓣膜结构内利用本文公开的心脏瓣膜,或任何其它可扩张的瓣膜比如在美国专利号8,613,765、美国专利号9,314,335、美国专利号9,364,322、美国专利号9,375,310和国际专利公布号WO 2012/018779中公开的,其公开内容通过引用明确地并入本文。
环路140可以被构造为单独的件并且附接/缝合至缝合圈136。可选地,可以通过在缝合圈136内和缝合圈136外缝合高拉伸强度纤维和将末端打结在一起来构造环路140,比如图9中显示的。当高拉伸强度纤维的自由端以绳结打结或卷曲时完成环路140。在一些实例中,环路140是单独制造的闭合环路,其在人工瓣膜的组装期间不需要打结或卷曲,这促进均匀的设定大小(sizing)和/或简化的制造。
图10显示了用于限制心脏瓣膜130扩张的环路150的另一个变体。在此变体中,环路150围绕上面描述的覆盖织物的内部支架的上部部分附接,并且包括允许瓣膜扩张的内置(built-in)缓和(relief)或松弛152。在支架的某一直径下,松弛152绷紧并且限制进一步的扩张(限制于一种或多种瓣膜大小)。
图11显示了瓣膜130的径向横截面,其具有上面描述的扩张限制环路的潜在放置位置。瓣膜130包括具有内部带160和外部带162的内部支架以及线型件164。小叶132的外边缘166被固定在织物覆盖的复合带160、162的上端和线型件164之间。缝合圈136被显示在其内表面处被附接至外部带162并且包括缝线可透过的插入物168,比如硅橡胶。在170a-170e处给出了扩张限制环路的可能放置位置。取决于放置,一定长度的松弛可以被包括在环路中,比如图10中的152处显示的。
显示的具体位置是:在170a处的缝合圈136的外边缘上、在170b处的支架(复合带160、162)的外边缘上、在170c处的支架的内侧、在170d处的支架的流入端处(支架内部)、和在170e处的缝合圈136的下侧处。这些位置中的每个具有织物覆盖物,比如在134处,并且因此缝线材料的环路可以在织物内和织物外被缝纫,或添加补充的针脚以保持其处于适当位置。
另外,可以跨越多种可扩张的外科瓣膜设计实施该具体的扩张限制方案,这是由于它独立于瓣膜的内部结构并且因此避免了对瓣膜内部结构的改造。此方法还可以允许定制量的扩张,其可以独立于瓣膜的内部结构的设计。
虽然已经关于具体的实施方式描述了某些原理,但是将理解可以做出多种改变和额外的变化并且可以将其元件替换为等价物,而不背离本公开内容的范围。此外,根据教导可以做出许多修改以适应特定的方案或装置而不背离其本质范围。因此,本公开内容不意欲限制于本文公开的具体的实施方式,而是将包括落入所附权利要求的范围内的所有实施方式。
Claims (12)
1.人工外科心脏瓣膜,其适合植入后扩张并且具有流入端和流出端,其包括:
瓣膜构件,其包括不可塌缩的内部结构支撑支架,其具有在流出方向中延伸和围绕所述支撑支架的外围均匀地间隔的三个直立的连合支柱,它们与相邻的连合支柱之间中途的三个弓形的流入尖突交替;和三个挠性小叶,其沿着所述支撑支架的所述连合支柱和流入尖突附接,其配置为确保通过所述瓣膜构件的单向血液流动,支撑支架外围限定了不可塌缩的递送和具有第一直径的植入物圆周,其中在从所述支撑支架内施加向外的膨胀力之后,所述支撑支架允许所述外围从所述第一直径扩张至大于所述第一直径的第二直径,所述向外的膨胀力大幅大于与正常的生理学用途相关联的力,所述支撑支架包括围绕所述外围延伸的结构带,其允许所述支撑支架扩张,并且所述瓣膜构件具有外部织物覆盖物和缝合至所述织物覆盖物的具有高拉伸强度的扩张限制挠性环路,其允许所述支撑支架从所述第一直径扩张至所述第二直径并且防止所述支架过度扩张超过所述第二直径。
2.权利要求1所述的人工心脏瓣膜,其中所述挠性环路由高拉伸强度纤维制成。
3.任何前述权利要求所述的人工心脏瓣膜,其中所述挠性环路被缝合至环绕所述支撑支架的所述流入尖突的所述瓣膜的缝线可透过的缝合圈的外边缘,所述缝合圈是可压缩的,以便于允许所述支撑支架从所述第一直径扩张至所述第二直径,直到所述挠性环路变得紧绷并且限制进一步的扩张。
4.权利要求3所述的人工心脏瓣膜,其中所述挠性环路使用间断的针脚围绕所述缝合圈被附接。
5.权利要求3所述的人工心脏瓣膜,其中所述挠性环路在所述缝合圈内和所述缝合圈外被缝合并且具有打结在一起的两个自由端。
6.权利要求1所述的人工心脏瓣膜,其中所述挠性环路直接围绕所述支撑支架被缝合至所述织物覆盖物的一部分,并且并入松弛段,其允许所述支撑支架从所述第一直径扩张至所述第二直径,直到所述挠性环路变得紧绷并且限制进一步的扩张。
7.任何前述权利要求所述的人工心脏瓣膜,其中所述结构带具有重叠的自由端,以便所述重叠的自由端的相对滑动允许所述支撑支架扩张。
8.权利要求7所述的人工心脏瓣膜,其中所述重叠的自由端在所述支撑支架的所述流入尖突中的单独一个处定位。
9.权利要求7所述的人工心脏瓣膜,进一步包括介于所述重叠的自由端之间的润滑的隔离物,其接合两个自由端。
10.权利要求7所述的人工心脏瓣膜,其中所述支撑支架包括针对连合带同心地布置的所述结构带,所述连合带限定所述支撑支架的三个直立的连合支柱,所述结构带在所述连合带的所述连合支柱处是截短的。
11.权利要求7所述的人工心脏瓣膜,其中所述支撑支架包括针对连合带同心地布置的所述结构带,所述连合带限定所述支撑支架的三个直立的连合支柱,所述结构带由金属制成并且所述连合带由聚合物制成。
12.任何前述权利要求所述的人工心脏瓣膜,进一步包括在植入后从主体外侧可见的所述支撑支架上独特的标识物,其将所述支撑支架标识为是可扩张的。
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EP3346952A4 (en) | 2019-05-29 |
CA2996687A1 (en) | 2017-03-16 |
CA2996687C (en) | 2023-12-19 |
CN108135699B (zh) | 2019-09-10 |
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WO2017044883A1 (en) | 2017-03-16 |
US20200383779A1 (en) | 2020-12-10 |
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US20230320849A1 (en) | 2023-10-12 |
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