CN102481189A - 带有具有凹入着陆区域的锚固结构的心瓣膜 - Google Patents
带有具有凹入着陆区域的锚固结构的心瓣膜 Download PDFInfo
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Abstract
提供一种用于在更换心瓣膜的植入时减少瓣膜侧泄漏的装置。瓣膜组件包括附连到锚固结构的组织或生物假体心瓣膜。锚固结构包括流入边缘，其横截面大致C形以形成凹入着陆区域。当植入在患者窦内时，锚固结构自行坐落，使得C形流入边缘的近端和远端被推压抵靠在大动脉环面的近端部分和远端部分上，从而有效地防止瓣膜侧泄漏。
Description
技术领域
本发明涉及用于生物假体心瓣膜更换系统的锚固结构。具体来说，本发明涉及由管状锚固结构支承的顺从易弯的(pliant)生物假体心瓣膜，该锚固结构具有流入端，流入端包括可减小瓣膜旁泄漏的凹入着陆区域。
背景技术
人体内生命流体的传送主要由瓣膜进行调节。生理瓣膜被设计为防止诸如血液、淋巴、尿液、胆汁等体液内回流，从而保持体液的动态单向性以维持合适的动态平衡。例如，静脉瓣膜保持血液的向上流动，特别是从最下端返回到心脏，而淋巴腺瓣膜阻止淋巴管、特别是四肢内的淋巴管内的淋巴回流。
因为瓣膜的共同功能，所以尽管相对尺寸上有变化，但各种瓣膜分享某些解剖学上的特征。心瓣膜是人体内最大的瓣膜，其直径可能超过30mm，而较小的静脉瓣膜可能具有不大于几分之一毫米的直径。然而，不管尺寸如何，许多生理瓣膜位于被称之为窦(sinuse)的特殊的解剖学结构内。瓣膜窦可被描述为容纳瓣膜的管壁内的膨胀或凸出部分。窦的几何形状具有瓣膜操作和瓣膜流体动力学方面的功能。其中一个功能是引导流体流以形成涡流，该涡流可防止瓣膜小叶在流速达到峰值时、例如在心脏收缩过程中粘附到管壁上。窦的几何形状的另一个功能是产生流体流，该流体流使小叶在回流压力开始时精确地关闭。窦的几何形状的重要之处还在于：当瓣膜小叶或尖头打开和关闭时，可减小由流体流动压差作用在瓣膜小叶或尖头上的应力。
因此，例如，发生在天生大动脉根部内的咽鼓管(瓦耳萨耳瓦氏管)窦内的涡流，业已表明在心脏收缩结束时对形成大动脉瓣膜的顺畅、逐渐和缓和的关闭是重要的。血液被允许沿着窦的弧形轮廓流动，并流到瓣膜小叶上以实现小叶的关闭，由此减小作用在瓣膜小叶上的压力，该压力不然由直接流体流动作用到小叶上。瓦耳萨耳瓦氏管窦还包含冠状心门，它们是馈送给心肌的动脉的流出开口。当瓣膜窦包含如此的流出开口时，瓣膜窦在全部的心脏循环中起作对如此血管提供血流的附加用途。
当瓣膜由于疾患或受伤而呈现出异常的解剖学结构和功能时，瓣膜天生进行调节的生理流体的单向流动受到干扰，从而导致流体静压增高。例如，静脉瓣膜功能紊乱导致血液回流和郁积在下腿内，造成疼痛、肿胀和水肿、肤色改变以及极难治愈的皮肤溃烂。淋巴腺瓣膜功能不全会导致淋巴水肿，造成组织纤维化和受影响身体部分的膨胀。心瓣膜疾病可导致肺动脉高压和水肿、心房纤维性颤动以及在二尖瓣和三尖瓣狭窄的病案中右心的失效；或肺动脉的拥塞、左心室收缩损伤，以及在二尖瓣回流和大动脉狭窄的病案中心脏拥塞的失效。不管何种病因，所有瓣膜疾病不是造成狭窄就是造成功能不全/回流，在前一种情况中，瓣膜不能适当地打开，从而阻碍流体流过并造成流体压力增高，在后一种情况中，瓣膜不能适当地关闭，从而流体通过瓣膜回漏而形成逆流。某些瓣膜遭受狭窄症和功能不全双重疾患，在此病案中，瓣膜既不能充分打开又不能完全关闭。
因为瓣膜疾病的临床诊断结果存在着潜在的严重性，所以可使用许多外科技术来修复疾患的或损伤的心瓣膜。例如，这些外科技术可包括瓣环成形术(收缩瓣膜的环面)、四边形切除术(使瓣膜小叶变窄)、连合部切开术(切开瓣膜连合部以分离瓣膜小叶)或瓣膜和环面组织的去钙化。或者，患者的心瓣膜可用假体瓣膜替换。在心瓣膜显示要做更换的情形中，通常要去除功能障碍的瓣膜并用机械的或组织的瓣膜替换。
在过去，一种常用的手术是开心手术。然而，开心的瓣膜修复或更换手术是时间长且令人厌烦的手术，其包括大的胸廓切开术，该手术通常呈中等胸骨切开的形式。在该手术中，使用锯或其它切割工具纵向地切开胸骨，肋骨架子的前部或腹部的两个相对半部被分开。因此形成通向胸腔的大开口，外科医生可通过该开口直接看到心脏和其它胸腔内器官并在其上可进行手术。心瓣膜更换通常包括缝合的环，且更换的瓣膜缝线到环面上，导致时间很长的外科手术。在外科手术期间，患者通常被放置在心肺机旁路中。
最小创伤瓣膜更换手术已经问世，作为对开胸手术的一种替代。最小创伤瓣膜更换手术是这样的一种手术：其通过皮肤或体腔或解剖学上的开口进入身体来实施手术，但对这些结构只有最小可能的损伤。已经问世的两种类型的最小创伤瓣膜更换手术是：经由皮肤的瓣膜手术和经心脏顶的瓣膜手术。经由皮肤的瓣膜手术是在皮肤上切开小的切口，允许直接进入外围脉管或身体通道以便插入导管。经心脏顶的瓣膜手术是在心脏顶部或靠近顶部切开小的切口以使瓣膜可进入。经由皮肤的瓣膜手术和最小创伤手术之间的区别还突出地出现在最近的进展陈述表中：Vassiliades Jr.TA，Block PC，Cohn LH，Adams DH，Borer JS，Feldman T，Holmes DR，Laskey WK，Lytle BW，Mack MF，WilliamsDO。经由皮肤的瓣膜手术的临床研发：胸外科学会(STS)，美国胸外科协会(AATS)，心脏血管造影术和干涉学会(SCAI)近期进展表。J Thorac CardiovascSurg 2005；129：970-6)。
随着瓣膜的植入越来越少地采取入侵方式，就减少了围绕环面缝合瓣膜的机会。然而，较少数量的缝线会增加瓣膜侧泄漏(paravalvular leakage)(PVL)的几率，即，围绕瓣膜周围的泄漏。较少数量的缝线还可增加瓣膜迁移机会和瓣膜在放置入体内时的稳定性。
Tehrani在美国专利申请号No.2006/0271172中公开了用于瓣膜植入的上和下O形环。该O形环覆盖瓣膜全部长度，并因此会不容易放置入大动脉窦区域内。Tehrani提出的O形环还阻塞冠状动脉流出并不利地影响瓣膜的动力学特性。O形环的非圆特性还减小了充分地符合于植入部位内不规则性所需的径向力，因此对于防止PVL和迁移都不是最佳的。由Tehrani提出的O形环的大尺寸还不是实用的，因为O形环不能容易地坍癟，对最小创伤瓣膜植入手术来说，这一点是必要的。
外科心瓣膜包括用于直接附连到天生环面上的缝合翻边，那里，外科医生依赖于可见的标识可正确地将流入环放置在环面内。然而，最小创伤的心瓣膜缺乏直接与环面接口的任何限定的特征，相反，要依赖于径向力来使瓣膜固定就位以防止瓣膜侧的泄漏。其它传统的设计依赖于“触头”来定位天生的小叶，并在定位时将瓣膜部署在触头下方，试图合适地将瓣膜坐落在环面内，由此，防止瓣膜侧的泄漏。还有其它传统的心瓣膜依赖于突缘的结构，其中，突缘使用双织物环将装置夹在天生环面内以防止瓣膜侧的泄漏。然而，双织物环需要有附加的外科手术时间，以使外科医生可确证两个环已放置在环面的相对侧上。
此外，尽管新的较小创伤的瓣膜对许多患者带来有益的结果，但这些瓣膜对于其它具有钙化或不规则环面的患者还不能发挥作用，因为紧密的密封不能形成在更换的瓣膜和植入部位之间。因此，医学上需要的是各种方法、系统和装置，用来减小心瓣膜周围的瓣膜侧泄漏，同时防止瓣膜迁移并允许瓣膜可坍癟。
本发明旨在解决或至少减少上述的某些问题或全部的问题。
发明内容
本发明提供用来减小瓣膜周围的瓣膜侧泄漏的方法和系统。由于瓣膜更换的入侵越来越小，减少了在环面周围缝合瓣膜的机会。然而，最大程度地减少用于固定更换瓣膜的缝线数量，却可能增加瓣膜侧泄漏(PVL)的几率，以及瓣膜迁移机会和瓣膜在放置入体内时的稳定性。
与心瓣膜相关的泄漏可以是瓣膜侧泄漏(瓣膜周围)或中心泄漏(通过瓣膜)。各种心瓣膜的实例包括大动脉瓣膜、二尖瓣、肺动脉瓣膜及三尖瓣。中心泄漏可通过心瓣膜设计来减小。另一方面，通过形成更换心瓣膜和植入部位之间的密封来阻止血液在更换心瓣膜周围的流动，可减小瓣膜侧的泄漏。重要的是，更换心瓣膜和植入部位之间的密封不能不利地影响周围的组织。此外，重要的还在于，该密封不影响更换的心瓣膜周围的流动动力学特性。在大动脉瓣膜的情形中，还为重要的是，该密封不阻碍冠状流动。
因此，本发明的一个目的是提供一种方法和装置，其能阻止诸如心瓣膜的更换瓣膜周围的瓣膜侧泄漏，同时还能阻止迁移。应该指出的是，尽管这里参照的是大动脉瓣膜，但本发明不局限于大动脉瓣膜。尽管更换的瓣膜通常植入在天生心瓣膜的位置，但这里所讨论的更换的瓣膜系统和密封装置可用于密封任何类型体内的瓣膜，而不会脱离本发明的范围。此外，尽管带有管状锚固结构的本发明心瓣膜可用于最小创伤瓣膜更换手术，诸如经由皮肤的瓣膜手术、经由股动脉的和经由心脏顶部的手术，但它不局限于如此的手术，还可用于外科的或所谓的“开胸”手术。
在本发明的一个实施例中，提供带有凹入着陆区域的管状锚固结构。该锚固结构包括具有近端或入口端和远端或出口端的本体。入口框架具有正弦波形的单轨或双轨结构，且通常被称之为入口边缘。出口框架具有正弦波形的单轨或双轨结构。锚固结构的本体可形成为各种形状，诸如菱形或六角形的型式。入口边缘的正弦波形的单轨或双轨结构的横截面呈C形，并形成本发明的凹入着陆区域。
在本发明另一个实施例中，提供了一种可减小瓣膜侧的泄漏的瓣膜组件。该瓣膜组件包括附连到锚固结构的生物假体组织的心瓣膜。锚固结构包括具有近端或入口端和远端或出口端的本体。入口框架具有正弦波形的单轨或双轨结构，且通常被称之为入口边缘。出口框架具有正弦波形的单轨或双轨结构，且通常被称之为出口边缘。入口边缘的正弦波形的结构的横截面呈C形，并形成本发明的凹入着陆区域。横截面内的C形结构提供生物假体的瓣膜，其是自坐落的和只需最小的调整。
在本发明另一个实施例中，提供适于植入在身体导管内的瓣膜假体，该装置包括主导管体，主导管体具有入口和出口以及附连在出口处的顺从易弯的小叶，这样，当流动通过导管从入口流道出口时，小叶处于打开位置中，允许流动流出出口，而当流动反过来时，小叶折叠而阻塞出口，其中，折叠的小叶可包括聚亚安酯或组织。
在本发明还有另一个实施例中，小叶在支撑梁处附连到主本体。
在本发明还有另一个实施例中，心瓣膜可在闭合位置和打开位置之间移动，在闭合位置中，相邻小叶的流出边缘彼此接合，而在打开位置中，相邻小叶的流出边缘彼此分离，但沿侧边缘除外，小叶的侧边缘的缝合部分使小叶朝向局部闭合位置偏置。
在本发明另一个实施例中，横截面中C形结构形成了着陆区域，其允许天生环面搁置在流入区域的低谷内，使张开的轨道位于环面的近端和远端。
在本发明还有另一个实施例中，生物假体的心瓣膜组件的凹入着陆区域，在生物假体的更换心瓣膜和植入部位之间提供有效的密封，以防止瓣膜侧的泄漏。
在本发明还有另一个实施例中，形成凹入着陆区域的流入边缘包括单轨结构。
在本发明还有另一个实施例中，形成凹入着陆区域的流入边缘包括双轨结构。
在本发明另一个实施例中，形成凹入着陆区域的流入边缘包括三轨结构。
在本发明另一个实施例中，单轨、双轨和/或三轨的结构可包括比远端部分长的近端部分，以与大动脉瓣膜窦的张口相匹配。
在本发明另一个实施例中，流入边缘的横截面区域包括框架的凹入部分与天生环面的直接对应。流入边缘的框架接合天生的环面，使张开的流入轨道位于环面上方和下方。自膨胀框架作用的径向力使瓣膜固定就位。
在本发明还有另一个实施例中，提供适于植入身体导管内的瓣膜假体装置，该装置包括大致圆柱形的锚固结构，其具有可展开的结构，适于先压边成适于外科的、经由心脏顶部、经由胸腔放置的狭窄结构，或可通过身体导管的其它导管插入术，以便到达目标部位，并通过径向压缩力的自膨胀作用，适于坐落在目标部位内，该圆柱形锚固结构设置有多个长度固定的纵向刚性或半刚性的支撑梁；瓣膜组件包括具有入口和出口且由顺从易弯性材料制成的柔性导管，其具有联接到支撑梁的连合片部分。
本发明提供防止瓣膜侧泄漏的方法。使用这里所述的单轨、双轨和/或三轨张开的设计，保证流入边缘基本上推压抵靠在大动脉上，因此形成紧密的密封，就可减小瓣膜侧的泄漏。在一种植入方法中，自膨胀的更换瓣膜可展开到带有递送构件的位置中，由此推压流入边缘抵靠在大动脉上而在瓣膜周围形成密封。换句话说，包括更换的心瓣膜的自膨胀的流入边缘提供了径向力，该力是将生物假体心瓣膜定位在环面内所必须的。
应当指出的是，用于本发明的术语“大致正弦形”用来包括由正弦和余弦函数表征的波形以及严谨地由这些函数表征但与该波形十分类似的波形。更一般地说，该波形包括那些表征为具有一个或多个峰和谷的波形。举例来说，峰和谷呈U形或球形隆起的波形要被包括在内。还要被纳入但不限制定义的是：形状更像三角形的波形，诸如锯齿波形或峰和谷呈矩形的波形。
尽管上述许多实施例是参照心脏大动脉瓣膜进行描述的，但本发明还可用于涉及其它瓣膜的手术，包括但不限于：二尖瓣、三尖瓣和肺动脉瓣膜。
本技术领域内的技术人员从以下结合附图的描述中，将会明了本发明上述诸方面、特征和优点。
附图说明
图1示出了正常操作过程中的示范瓣膜。图1A示出了峰值流动过程中处于打开位置中的瓣膜。图1B示出了处于关闭位置中的瓣膜，以便阻止流体横过瓣膜回流。
图2A是示出典型大动脉瓣膜的解剖学结构的俯视图。
图2B是图2A所示的大动脉瓣膜的剖视图。
图2C是图2A所示的大动脉瓣膜的立体图，用虚线示出流入端、流出端以及连合柱。
图3是瓣膜窦区域的几何形状和相对尺寸的示意图。
图4是用于本发明的示范的生物假体瓣膜。
图5A是根据本发明的管状锚固结构的示范实施例的立体图，其沿线A-A剖切并显示凹入着陆区域。
图5B是图5A所示的凹入着陆区域的剖视图。
图6A是根据本发明的锚固结构的示范实施例的立体图，其沿线A-A剖切并显示凹入着陆区域。
图6B是图6A所示的凹入着陆区域的剖视图。
图7A是显示His束的心脏示意图。
图7B示出包括图4所示生物假体心瓣膜的图5A所示管状锚固结构的示范实施例，示出定位在大动脉内的凹入着陆区域。
图8示出包括单轨张开或凹入流入边缘的管状锚固结构的示范实施例，其尺寸确定为可容纳在窦腔内。
图9示出图8所示单轨张开或凹入流入边缘的另一替代的立体图。
图10示出带有联接到管状锚固结构的顺从易弯性小叶的示范的心瓣膜假体，该管状锚固结构包括被选项的覆盖物覆盖的凹入着陆区域。
具体实施方式
尽管本发明可实施为许多不同的形式，但这里要详细地本发明的各种实施例。该描述是对本发明原理的示范，并不意图将本发明限制到所示特殊的实施例。
为了一致性起见，术语“峰”和“谷”是相对于根据本发明的锚固结构的近端和远端定义的。如图中所见，各个管状锚固结构具有流入端(这里称之为流入边缘)和流出端(这里称之为流出边缘)。就流入端和流出端而言，诸“峰”相对于锚固结构近端是凹入的，而相对于锚固结构远端是凸出的。另一方面，诸谷相对于锚固结构近端是凸出的，而相对于锚固结构远端是凹入的。
现转到附图中，本发明涉及减小心瓣膜中瓣膜侧泄漏的方法、系统和装置。图1A和1B总地示出了心瓣膜1的一个示范实施例。如图1所示，瓣膜1包括远端的流出端2、多个小叶3以及近端的流入端4。与折叠管相类似的典型的瓣膜功能在于，它在心脏收缩期间敞开地打开，或响应于心肌的收缩，能使向前流动无阻碍地流过瓣膜孔，如图1A所示。相比之下，当向前的流动在心脏收缩或紧缩结束时减速时，管子壁被强制中心地位于与血管壁附连的各侧之间，瓣膜完全地关闭，如图1B所示。
图2A、2B和2C示出了典型大动脉瓣膜的解剖学结构。尤其是，图2A示出了带有三个瓣膜窦的关闭瓣膜的俯视图，图2B示出了关闭瓣膜的剖开的立体图，图2C示出了从血管壁外面观看的视图。
瓣膜更换系统和装置设计中一个重要的考虑之处是瓣膜窦的结构。瓣膜窦12是包围天生瓣膜小叶的血管壁的膨胀部分。通常在大动脉瓣膜中，各个天生瓣膜小叶具有单独的窦突起12或内腔，其允许小叶在峰值流动时最大地打开，而不允许小叶和血管壁之间接触。如图2A、2B和2C所示，窦12的范围通常由连合部11、血管壁13、流入端14和流出端15定义。窦腔之间的近端相交定义了连合部11。
图2B和2C还示出流入端14和流出端15处窦的变窄的直径，因此，分别形成窦区域的环面和窦管状的连接。因此，瓣膜窦形成天生的隔间，通过防止小叶和血管壁之间的接触，来支持瓣膜的操作，这又可导致小叶的粘连和/或导致小叶变劣的磨损和撕裂。瓣膜窦还设计成在闭合过程中当作用在闭合小叶上的流体压力为最大时，享有作用在瓣膜小叶上的应力状态。瓣膜窦还形成有利的流体动力学的流过的流体流，在高的回流压力条件下，流体流缓和小叶的其它形式的陡然的闭合。最后，窦确保流向位于窦腔内的任何血管的恒定流动。
图3是瓣膜窦区域的几何形状和相对尺寸。如图3所示，瓣膜窦区域的特征在于，不管窦的实际大小如何，某些相对尺寸保持基本上恒定不变。一般地说，窦的直径在窦腔16中心处为最大，而在靠近流入端14的流入环面17和靠近流出端15的流出窦管状连接18处，窦区域存在有明显的变窄。此外，窦19的高度(即，流入环面17和流出环面18之间的距离)保持基本上正比于其总尺寸。因此，显然，窦区域形成解剖学上的隔间，隔间具有某些恒定的特征，它们独特地适于容纳瓣膜。本发明的系统和装置设计成利用天生窦区域的这些解剖学上的特征，以达到最佳的更换瓣膜的功能和定位。
图4是更换瓣膜22的立体图，其表示用于根据本发明瓣膜更换系统的典型的三小叶的更换瓣膜的一个示范实施例。本技术领域内的技术人员应当意识到的是，更换瓣膜还可以是二小叶的结构。更换瓣膜22包括具有近端流入端31和远端流出端32的瓣膜体30。瓣膜体30包括多个瓣膜组织小叶33，它们通过缝合、缝针或其它方式连接起来的接缝34而连接，其中，各个接缝34由两个小叶33的接头形成。连合片35由从瓣膜体30远端处的各个接缝34延伸的瓣膜材料同延地形成。瓣膜体30的流入端31包括可以是扇形或直线的外围边缘。此外，瓣膜体30的流入端31可供选择地包括加强结构36，其可联接、缝合、粘结或化学方法连接或其它方式附连。根据本发明的瓣膜更换系统还可包括加强结构，加强结构联接到生物假体的组织瓣膜并围绕管状锚固结构的流入端定位，这将在下文中描述。加强结构可包括布料或促进组织向内生长的任何多孔材料。该加强结构可帮助瓣膜假体定位和固定在正确的位置。例如，它可在瓣膜放置在大动脉位置内时帮助瓣膜假体固定在流入的环面处。
然而，本发明的瓣膜更换系统和装置不局限于图4所示的特殊瓣膜。例如，尽管瓣膜体30的近端流入端31在图4中显示有扇形的外围边缘，但也可考虑其他形状和构造，并纳入在本发明的范围之内。瓣膜小叶33可用任何合适材料构造，包括但不限于：膨胀的聚四氟乙烯(ePTFE)、马心包膜、牛心包膜，或类似于目前可供的生物假体大动脉瓣膜的天生猪瓣膜小叶。正如本技术领域内技术人员应当意识到的是，可证明其它材料是合适的。
图5A是根据本发明的管状锚固结构24的示范实施例的立体图，其沿线A-A剖切并放平而显示凹入着陆区域60。图5A代表可用于根据本发明的瓣膜更换系统20的典型锚固或支承结构24的一个示范实施例。一般地说，管状锚固结构24被设计为可折叠和膨胀的锚固结构，该结构适于沿着连合片区域35朝向远端地和沿着近端流入端31朝向近端地支承瓣膜22。如图5A所示，瓣膜22与管状锚固结构24脱离开，以便集中在管状锚固结构的结构和特征上。
锚固结构24具有大致的管状或圆柱形构造，更换瓣膜22可固定在该构造内，并可包括流入边缘41、支承柱42和流出边缘43。更换瓣膜22可通过与管状锚固结构24的流入边缘41的附连而固定在近端流入端31处，通过前进通过沿轴向延伸的狭槽44的连合片固定在远端流出端32处，轴向延伸的狭槽44形成在支承柱42内，支承柱42沿纵向从管状锚固结构24的流入边缘41延伸到流出边缘43。因此，支承柱42的远端45接触到管状锚固结构24的流出边缘43，而支承柱42的近端46接触到管状锚固结构24的流入边缘41。支承柱42可以是刚性的、基本刚性的，或也可包括向内的挠曲度。
如图5A所示，支承结构24的流出边缘43显示为包括延伸在支承柱42之间的单金属丝环或轨，支承柱42大致在驻留其中轴向延伸的狭槽44之处或在其上方。流出边缘43
构造成波浪形或正弦波型，其形成峰47和谷48。然而，包括流出边缘43的轨道数量可包括由本发明构思出的许多其他的构造，并可被用作为变化型式的单轨、双轨和三轨的构造。流入边缘41显示为包括双金属丝环或轨，该金属丝或轨包括远端流入金属丝环49和近端流入金属丝环51。远端流入金属丝环49和近端流入金属丝环51构造成波浪形或正弦波型，其形成峰47和谷48。如图中所见，双金属丝柜构造成近端流入金属丝环51的峰47联接到远端流入金属丝环49的谷48，由此形成菱形图形，但也可实现任何数量的理想形状，例如，五边形、六边形、矩形等，所有这些都在本发明范围之内。
流入边缘41选项地包括定位在远端流入金属丝环49和近端流入金属丝环51之间的指形元件53，该元件53沿着轴向方向从其中延伸出来。指形元件53设计成对覆盖流入边缘41的织物给予附加的支撑，以锚固织物并允许组织向内生长。
在图5A所示的管状锚固结构24的示范实施例中，流出边缘43形成有单环，而流入边缘41形成有延伸在支承柱42之间的双环。然而，环的数量可变化，可构思许多其它的构造。例如，图6A示出用于流入边缘的三环构造，而图8示出用于流入边缘的单环构造。
管状锚固结构24的流入边缘41和流出边缘43可形成有波浪形或正弦波形的构造。在管状锚固结构的各种实施例中，流入边缘41可具有比流出边缘43较短或较长的波长(即，从峰至峰的圆周尺寸)和/或较小或较大的波高(即，峰至峰的轴向尺寸)。可选择流入边缘41和流出边缘43的波长和波高，来确保管状锚固结构24均匀的压缩和膨胀而基本上无扭曲。流入边缘41的波长还可选择来支持与其附连的瓣膜的流入端的几何形状，诸如图4中所示更换的瓣膜22的扇形流入端31。值得注意的是，如图5A所示，形成管状锚固结构24的流入边缘41的波浪形或正弦波型可构造成：使垂直支承柱42的近端46连接到远端流入环49的谷48。在瓣膜递送之前处于其径向受压缩状态因此防止对生物假体的心瓣膜造成可能损坏时，该结构允许远端流入金属丝环和近端流入金属丝环一起移动。类似地，形成管状锚固结构24的流出边缘43的波浪形或正弦波型可构造成：使支承柱42的远端45连接到流出边缘43的峰47。
如图6A所示，图中示出流入边缘41的替代的实施例。流入边缘41包括三轨结构，该结构包括远端流入环49、近端流入环51以及中心流入环62。在该用于流入边缘41的替代的三轨结构中，近端流入环51的峰47可连接到中心流入环62的谷64。中心流入环62的峰47可连接到远端流入环49的谷48。在瓣膜递送之前处于其径向受压缩状态因此防止对生物假体的心瓣膜造成可能损坏时，该结构允许远端流入金属丝环和近端流入金属丝环一起移动。
图5A和6A还示出支承柱42的远端45大致构造成桨叶的形状，该桨叶带有内部延伸在桨叶叶片50内的轴向狭槽44。桨叶的叶片50朝向管状锚固结构24的流出边缘43定向，并在流出边缘43的波浪形或正弦波型的谷处连接到流出边缘43。支承柱42的重要功能是使假体瓣膜22稳定，尤其是防止瓣膜附连点处出现的任何纵向延伸，排除一旦更换的瓣膜系统20受压缩后出现的瓣膜伸展或扭曲。桨叶形支承柱42的叶片50还设计成容纳瓣膜22的连合片35。
支承柱42的数量一般地在两至四的范围内，根据瓣膜窦内存在的连合柱的数量而定。因此，在本发明的一个实施例中，管状锚固结构24包括用于三小叶的更换瓣膜22的三个支承柱，瓣膜22带有特征为三个天生连合柱的窦。管状锚固结构24的支承柱32可构造成大致与瓣膜窦的天生连合柱相一致。
管状锚固结构24可由任何合适材料形成，合适材料包括但不限于不锈钢或镍钛诺。选用于管状锚固结构24的特别材料，可根据支承结构是自膨胀还是非自膨胀的来确定。例如，自膨胀支承结构的较佳材料可包括诸如镍钛诺那样的形状记忆材料。
现转到图5B和6B，图中示出流入边缘41的剖视图，其示出了根据本发明的凹入着陆区域60。如图中可见，远端流入环49的峰47和近端流入环51的谷48向外张开，以使流入边缘41在展开之后形成横截面中的C形。流入边缘41的该横截面区域60，或换句话说，框架的凹入部分，直接对应于天生的环面。流入边缘的框架接合天生环面，使张开的轨道49、51位于环面上方和下方。一旦部署后，自膨胀框架作用的径向力将瓣膜固定就位。
本发明的凹入着陆区域60基本上可防止瓣膜侧泄漏。使用如图5A、5B、6A、6B、8和9所示的双轨、三轨和单轨的张开设计，由于确保了流入边缘41、841基本上固定在环面的近端和远端，因此形成了紧密的密封，由此可减小瓣膜侧泄漏。凹入着陆区域60还使得外科医生易于将生物假体的心瓣膜放置在环面内，因此使患者花费在外科手术中的时间减到最少。
图7A是心脏700的示意图，心脏700具有右和左心房710、712，右和左心室714、716，大动脉716和大动脉心瓣膜718。His束(心肌束)720也被称之为AV束或房室束，其包括专用于导电的心肌细胞的集合，将电脉冲从AV节点722(位于心房和心室之间)发送到簇生的分支顶点。然后簇生的分支引向浦肯雅(Purkinje)纤维，该浦肯雅纤维神经支配心室，致使心室的心肌按照节律收缩。如果His束被阻塞，则就会发生被称之为“第三度心传导阻滞”的严重病情，即，心房活动和心室活动之间的联系断开。第三度心传导阻滞最有可能需要人工起搏器。因此，因为心瓣膜的支架部分影响到His束，所以，大量的心瓣膜更换手术会导致要植入起搏器的第二次手术。
因此，本技术领域内的技术人员应当意识到的是，有许多不同的构造可用于远端和近端流入环49、51。例如，各个远端和近端流入环49、51可基本上是相同的垂直高度。如果各个远端和近端流入环49、51是基本上相同的垂直高度，则近端环可稍许少向外张开来避免对His束的损害或影响，而缘端环49可稍许更向外张开来确保与大动脉环面远端侧牢固的接合。或者，近端流入环51可构造成比远端流入环短，或可稍许更向外张开，这样，一旦放置好，近端流入环不会接触和影响His束。或者，无论远端还是近端流入环49、51都可构造成短于其它的环，根据特殊患者的解剖学结构和所包括的瓣膜更换而定。然而，本技术领域内的技术人员应当意识到的是，远端和近端流入环49、51可包括任何数量的可变垂直高度和张开度，而不会脱离本发明的精神。
如图7B所示，包括图5A和/或6A的示范管状锚固结构24的心瓣膜更换系统20已在大动脉A的窦腔内膨胀开，由此迫使流入边缘41抵靠在大动脉A的流入环面64上，以在更换瓣膜20和大动脉A之间形成紧密的密封。具体来说，一旦部署好，流入边缘41呈现横截面大致为C形的凹入着陆区域60，如图5B、6B和7中所见。远端流入环49邻接环面的远端侧，而近端流入环51邻接天生环面的进端侧。
凹入着陆区域60防止瓣膜侧的泄漏和更换瓣膜22离植入部位的迁移，和/或使上述现象减到最小。因此，由于流入边缘41与流入环面64接触，所以，凹入着陆区域60起作垫圈来密封更换瓣膜系统20和大动脉A之间的接头。可供选择地，流入环41用织物覆盖来刺激组织随着时间推移而向内生长，并将更换的心瓣膜固定就位。该织物可包括任何合适的材料，包括但不限于纺织的聚酯、聚酯丝绒、聚乙烯对苯二酸酯、聚四氟乙烯(PTFE)，或其它生物兼容的材料。瓣膜组件可被压缩在冰内，加载到递送系统内，并部署到大动脉瓣膜位置中。锚固结构的自膨胀特征提供了植入之后将瓣膜固定就位所需的径向强度。
现转到图8和9，图中示出了带有根据本发明远离的凹入着陆区域的锚固结构的还有另一替代实施例。示出由大致圆柱形或管状锚固结构824支承的瓣膜822，该锚固结构824具有凹入着陆区域860。瓣膜822包括可供选择的加强结构837。在该实施例中，锚固结构824利用菱形结构和六角形的结构，这样的结构便于折叠和动态的屈服顺从易弯。然而，本技术领域内的技术人员应当意识到的是，对于可采用锚固结构，存在有许多种设计。如图8和9中所见，流入边缘841包括单金属丝环，其构造成从垂直支承柱向外张开，以将它牢固地锚固抵靠在大动脉流入的瓣膜窦上，就如以上所公开的。图示为具有两个轨结构的流出环866还可供选择地向外张开，以将它锚固抵靠在瓣膜窦的大动脉流出的环面上。锚固结构824的流出环866适于支承瓣膜822的连合片区域821，而图示为具有单轨结构的流入环841允许锚固结构824可靠地定位在脉管通道的窦腔内。连合片35可直接缝合到流出边缘，或可选择地，可缝合到支承柱850。锚固结构824的张开的流入环841的单环可包括波浪形或锯齿形型式，瓣膜可供选择的织物环或缝合翻边837可缝合到上述型式上。锚固结构的流入环841可通过垂直支承柱850连接到流出环866，该垂直支承柱850定位成与天生窦区域的连合柱相一致。然而，应该理解到，垂直支承柱的数量可适合于存在于特殊窦区域内的天生连合柱的数量。
本技术领域内的技术人员应当意识到的是，存在有许多可用于流入环841或流出环866构造的不同的构造。例如，各个峰和谷可基本上是相同的垂直高度。或者，无论是峰还是谷都可构造成短于其它的，根据特殊患者的解剖学结构和所包括的瓣膜更换而定。然而，本技术领域内的技术人员应当意识到的是，单环结构可包括任何数量的垂直高度，而不会脱离本发明的精神。
参照图10，图中示出了安装在带有凹入着陆区域(未示出)的管状锚固结构内的假体心瓣膜22的立体图。瓣膜22是可用于根据本发明的带有凹入着陆区域60的管状锚固结构24的典型的三小叶更换心瓣膜的示范实施例。本技术领域内的技术人员应当意识到的是，更换瓣膜还可以是二小叶的结构。更换瓣膜22包括具有近端流入端31和远端流出端32的瓣膜体30。瓣膜体30包括多个瓣膜组织小叶33。由瓣膜材料同延地形成的连合片35从瓣膜体30远端处的各个接缝34延伸出来。如图10所示，瓣膜体30的流入端31可供选择地包括加强结构36，其可联接、缝合、粘结或化学方法连接或其它方式附连。根据本发明的瓣膜更换系统20还可包括加强结构，加强结构联接到生物假体的组织瓣膜并围绕管状锚固结构的流入端定位。加强结构可包括布料或促进组织向内生长的任何多孔材料。该加强结构可帮助瓣膜假体定位和固定在正确的位置。例如，它可在瓣膜放置在大动脉位置内时帮助瓣膜假体固定在流入的环面处。其可联接、缝合、粘结或化学方法连接或其它方式附连。根据本发明的瓣膜更换系统还可包括加强结构，加强结构联接到生物假体的组织瓣膜并围绕管状锚固结构的流入端定位，这将在下文中描述。加强结构可包括布料或促进组织向内生长的任何多孔材料。该加强结构可帮助瓣膜假体定位和固定在正确的位置。例如，它可在瓣膜放置在大动脉位置内时帮助瓣膜假体固定在流入的环面处。管状锚固结构24的单一流出轨道43可操作地联接到桨叶形的叶片50上。在使用中，瓣膜22的连合片35与形成在支承柱42内的轴向地延伸的狭槽44对齐。狭槽44的总体尺寸对应于连合片35的尺寸。此外，连合片35可操作地用布料覆盖物37覆盖。
如上所指出的，瓣膜小叶33可用任何合适材料构造，包括但不限于：膨胀的聚四氟乙烯(ePTFE)、马心包膜、牛心包膜，或类似于目前可供的生物假体大动脉瓣膜的天生猪瓣膜小叶。正如本技术领域内技术人员应当意识到的是，可证明其它材料也是合适的。
应该指出的是，根据本发明的新颖锚固结构装置和生物假体瓣膜系统，设计成可配用于无需任何类型缝合的环面内。然而，本技术领域内的技术人员还应当意识到的是，将生物假体瓣膜系统固定在环面内可以使用缝合线，也可不使用缝合线。
在制造过程中，锚固结构从较小的管子中切割下，并膨胀和加热到最后要求的尺寸。根据设计，双环和三环结构中的单流入环的末端和远端流入环和近端流入环的末端可向外张开，以形成从锚固结构框架的圆柱形体延伸出的横截面为C形的凹入区域。诸如图5A中所示的附加的指形物可用于任何的结构中，并可向外张开以帮助接合环面和支撑织物覆盖物。
尽管本发明参照优选实施例进行了描述，但本技术领域内的技术人员应当意识到的是，在形式和细节上还可作出各种变化，而不会脱离本发明的精神和范围。
Claims (41)
1.一种构造成定位在大动脉环面内的假体心瓣膜，该假体心瓣膜包括：
大致圆柱形锚固结构，其具有流入端、流出端和介于两者之间的多个支承柱；
由管状体在流入端处形成的流入边缘，所述流入边缘包括至少一个轨道，所述轨道具有向外张开的远端部分和近端部分，它们构成横截面大致C形的凹入着陆区域；
顺从易弯的假体心瓣膜，其包括多个小叶，所述小叶沿着其侧边缘的至少一部分联接在一起，以便构成具有流入端和流出端的大致管状瓣膜结构，所述流出端包括多个与所述小叶一体形成的连合片，所述连合片联接到所述支承柱，
其中，心瓣膜可在闭合位置和打开位置之间移动，在闭合位置中，相邻小叶的流出边缘彼此接合，而在打开位置中，相邻小叶的流出边缘彼此分离，但沿侧边缘除外，小叶的侧边缘的缝合部分使小叶朝向局部闭合位置偏置。
2.如权利要求1所述的假体心瓣膜，其特征在于，所述流入边缘包括单轨。
3.如权利要求1所述的假体心瓣膜，其特征在于，所述流入边缘包括双轨，所述双轨包括远端流入环和近端流入环。
4.如权利要求3所述的假体心瓣膜，其特征在于，所述远端流入环和所述近端流入环构造成正弦波型，该波型构成多个峰和多个谷。
5.如权利要求4所述的假体心瓣膜，其特征在于，所述近端流入环的所述多个峰中的至少其中一个峰可操作地连接到所述远端流入环的所述多个谷中的至少其中一个谷。
6.如权利要求1所述的假体心瓣膜，其特征在于，还包括多个指形元件，它们从所述流入边缘轴向延伸。
7.如权利要求3所述的假体心瓣膜，其特征在于，还包括多个指形元件，它们从所述近端流入环和所述远端流入环轴向延伸。
8.如权利要求1所述的假体心瓣膜，其特征在于，还包括具有至少一个轨道的流出边缘，所述流出边缘可操作地与所述管状体连接。
9.如权利要求8所述的假体心瓣膜，其特征在于，所述流出边缘包括张开的远端和近端部分，它们构成横截面大致C形的凹入着陆区域。
10.如权利要求1所述的假体心瓣膜，其特征在于，所述流入边缘包括三轨，所述三轨包括可操作地连接到中心流入环的远端流入环和可操作地连接到所述中心流入环的近端流入环。
11.如权利要求10所述的假体心瓣膜，其特征在于，所述远端流入环、所述中心流入环和所述近端流入环构造成正弦波型，该波型形成多个峰和多个谷。
12.如权利要求11所述的假体心瓣膜，其特征在于，所述远端流入环的所述峰可操作地连接到所述中心流入环的谷，所述中心流入环的峰可操作地连接到所述近端流入环的谷。
13.如权利要求1所述的假体心瓣膜，其特征在于，还包括多个纵向支承柱，它们连接所述流入边缘和流出边缘。
14.如权利要求13所述的假体心瓣膜，其特征在于，所述支承柱包括大致桨状叶片，所述桨状叶片具有通过其中的轴向狭槽和细长的垂直构件。
15.如权利要求14所述的假体心瓣膜，其特征在于，所述细长的垂直构件联接到所述流入边缘，而所述叶片联接到所述流出边缘。
16.如权利要求15所述的假体心瓣膜，其特征在于，还包括生物假体心瓣膜，所述生物假体心瓣膜包括至少两个可操作地与所述叶片联接的连合片。
17.如权利要求13所述的假体心瓣膜，其特征在于，所述多个纵向支承柱包括两个支承柱。
18.如权利要求13所述的假体心瓣膜，其特征在于，所述多个纵向支承柱包括三个支承柱。
19.如权利要求1所述的假体心瓣膜，其特征在于，横截面为所述C形的凹入着陆区域的所述远端部分构造成位于大动脉环面的远端侧附近，而横截面为所述C形的凹入着陆区域的所述近端部分构造成位于大动脉环面的近端侧附近。
20.如权利要求19所述的假体心瓣膜，其特征在于，横截面为所述C形的凹入着陆区域的所述近端部分构造成避免与His束接触。
21.如权利要求1所述的假体心瓣膜，其特征在于，横截面为所述C形的凹入着陆区域构造成在假体心瓣膜和大动脉环面之间形成密封。
22.如权利要求21所述的假体心瓣膜，其特征在于，所述密封基本上减小或阻止瓣膜侧泄漏。
23.如权利要求21所述的假体心瓣膜，其特征在于，所述密封基本上防止所述心瓣膜移离植入部位。
24.一种适于锚固在身体血管内的锚固结构，所述锚固结构包括具有流入端和流出端的大致圆柱形管状体；以及与所述管状体在流入端同延形成的流入边缘，所述流入边缘包括至少一个轨道，所述轨道具有向外张开的远端部分和近端部分。
25.如权利要求24所述的假体心瓣膜，其特征在于，所述流入边缘包括单轨。
26.如权利要求24所述的假体心瓣膜，其特征在于，所述流入边缘包括双轨，双轨包括远端流入环和近端流入环。
27.如权利要求26所述的锚固结构，其特征在于，所述远端流入环和所述近端流入环构造成正弦波型，该波型形成多个峰和多个谷。
28.如权利要求27所述的锚固结构，其特征在于，所述近端流入环的所述多个峰中的至少其中一个峰，可操作地连接到所述远端流入环的所述多个谷中的至少其中一个谷。
29.如权利要求24所述的锚固结构，其特征在于，还包括多个指形元件，它们从所述流入边缘轴向延伸。
30.如权利要求26所述的锚固结构，其特征在于，还包括多个指形元件，它们从所述近端流入环和所述远端流入环轴向延伸。
31.如权利要求24所述的锚固结构，其特征在于，还包括具有至少一个轨道的流出边缘，所述流出边缘可操作地与所述管状体连接。
32.如权利要求31所述的锚固结构，其特征在于，所述流出边缘包括张开的远端和近端部分，它们形成横截面大致C形的凹入着陆区域。
33.如权利要求24所述的锚固结构，其特征在于，所述流入边缘包括三轨，三轨包括可操作地连接到中心流入环的远端流入环和可操作地连接到所述中心流入环的近端流入环。
34.如权利要求33所述的锚固结构，其特征在于，所述远端流入环、所述中心流入环和所述近端流入环构造成正弦波型，该波型形成多个峰和多个谷。
35.如权利要求34所述的锚固结构，其特征在于，所述远端流入环的所述峰可操作地连接到所述中心流入环的谷，所述中心流入环的峰可操作地连接到所述近端流入环的谷。
36.如权利要求24所述的锚固结构，其特征在于，还包括多个纵向支承柱，它们连接所述流入边缘和流出边缘。
37.如权利要求36所述的锚固结构，其特征在于，所述支承柱包括大致桨状叶片，所述桨状叶片具有通过其中的轴向狭槽和细长的垂直构件。
38.如权利要求37所述的锚固结构，其特征在于，所述细长的垂直构件联接到所述流入边缘，而所述叶片联接到所述流出边缘。
39.如权利要求38所述的锚固结构，其特征在于，还包括生物假体心瓣膜，该生物假体心瓣膜包括至少两个可操作地与所述叶片联接的连合片。
40.如权利要求36所述的锚固结构，其特征在于，所述多个纵向支承柱包括两个支承柱。
41.如权利要求36所述的锚固结构，其特征在于，所述多个纵向支承柱包括三个支承柱。
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- 2010-04-07 WO PCT/US2010/001043 patent/WO2010141047A1/en active Application Filing
- 2010-04-07 PT PT201727005T patent/PT3760164T/pt unknown
- 2010-04-07 ES ES20172700T patent/ES2902446T3/es active Active
- 2010-04-07 CN CN201080025834.8A patent/CN102481189B/zh active Active
- 2010-04-07 EP EP20172700.5A patent/EP3760164B1/en active Active
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| CN104000672A (zh) * | 2013-02-25 | 2014-08-27 | 上海微创医疗器械（集团）有限公司 | 心脏瓣膜假体 |
| WO2014127750A1 (zh) * | 2013-02-25 | 2014-08-28 | 上海微创医疗器械（集团）有限公司 | 心脏瓣膜假体 |
| CN104000672B (zh) * | 2013-02-25 | 2016-06-15 | 上海微创心通医疗科技有限公司 | 心脏瓣膜假体 |
| US10918479B2 (en) | 2013-02-25 | 2021-02-16 | Shanghai Microport Cardioflow Medtech Co., Ltd. | Heart valve prosthesis |
Also Published As
| Publication number | Publication date |
|---|---|
| EP4487817A2 (en) | 2025-01-08 |
| US20100100176A1 (en) | 2010-04-22 |
| CN102481189B (zh) | 2014-12-10 |
| EP2437688A1 (en) | 2012-04-11 |
| EP2437688B1 (en) | 2020-05-06 |
| EP3760164A1 (en) | 2021-01-06 |
| WO2010141047A1 (en) | 2010-12-09 |
| US9579194B2 (en) | 2017-02-28 |
| EP4014927A1 (en) | 2022-06-22 |
| ES2902446T3 (es) | 2022-03-28 |
| PT3760164T (pt) | 2021-12-31 |
| JP2012528670A (ja) | 2012-11-15 |
| EP2437688A4 (en) | 2018-01-10 |
| EP3760164B1 (en) | 2021-11-17 |
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