CN101208058A - 治疗后叶脱垂的设备、系统和方法 - Google Patents
治疗后叶脱垂的设备、系统和方法 Download PDFInfo
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Abstract
本发明是一种修复心脏瓣膜的设备,系统和方法。缝合线固定到乳头肌,然后穿过部分心脏瓣叶。参考元件(106)提供在距离由心脏瓣环(100)定义的平面所需的距离处。该缝合线在邻近参考元件的位置处固定到心脏瓣叶。参考元件可以是经配置放置在心脏瓣环上或心脏瓣环内的装置的一部分。参考元件可滑动地固定到该装置以便参考元件与装置主体的距离可由外科医生或其他用户改变。参考元件可以是缝合线,该参考元件可在装置制造过程中预安装或由外科医生或其他用户安装。
Description
相关申请的交叉参考
【0001】本申请要求共同授予2005年6月27日申请的美国临时专利申请60/694479的优先权,该申请全部内容包括在此以供参考。
技术领域
【0002】本申请一般涉及医疗装置,具体涉及修复二尖瓣后叶脱垂。
背景技术
【0003】在脊椎动物中,心脏是中空肌肉器官,其具有四个泵室:左心房和右心房,及左心室和右心室,每个都提供有其自身的单向阀门。自然心脏瓣膜被标识为动脉瓣,二尖瓣(或双尖瓣),三尖瓣和肺动脉瓣,且每个都固定在包括厚密瓣环的环状部(annulus)。二尖和三尖瓣膜具有螺纹状纤维组织带,该纤维组织在一端固定到瓣膜并在另一端固定到乳头肌。
【0004】心脏瓣膜疾病是常见疾病,心脏瓣膜中的一个或多个心脏瓣膜不能正常工作。患病的心脏瓣膜可分类为瓣膜窄,其中瓣膜不能充分打开从而允许血液适当正向流过瓣膜,和/或分类为功能不全,其中瓣膜不能完全闭合,引起在瓣膜闭合时血液过度回流通过瓣膜。如果不治疗,则瓣膜疾病可能严重使病人衰弱甚至致命。
【0005】多种外科手术技术可用来修复患病或损伤的瓣膜。一种治疗有缺陷瓣膜的方法是通过修复或重构。一种被证明治疗功能不全有效的修复技术是瓣膜成形术(annuloplasty),其中瓣环的有效尺寸和/或形状是通过在心脏瓣膜环附近固定修复段(repair segment),如瓣膜成形术瓣环而改进的。例如,瓣膜环可通过连接修复瓣膜成形术的修复段或环至心脏内壁瓣膜环附近而收缩。瓣膜成形术环被设计来支持在心动周期中发生的功能变化:保持结合和瓣膜整体性从而防止逆流,同时在正向流动过程中允许良好的血液动力学。
【0006】瓣膜成形术环通常包括常由金属(如不锈钢或钛)或柔性材料(如硅橡胶或涤纶绳或索(Dacron cordage))形成的内衬底,该衬底通常被覆盖以生物适应的织物或布料从而允许环与心脏组织缝合。根据具体应用,瓣膜成形术环可以是刚性的或柔性的,可以是分开的或连续的,并可以具有多种形状,包括圆形,D形,C形,鞍形,和/或肾脏形状的。这些例子可在美国专利No.5041130,5104407,5201880,5258021,5607471,6187040和6805710中可见,它们的内容完全包括在此以供参考。许多瓣膜成形术环都是在平面内形成的,但某些环通常是非平面的。这类非平面环可以是鞍形的,和/或沿多个部分弯曲,如沿它们的前面或直边弯曲从而符合该位置处瓣环的所需形状。
【0007】在许多患病瓣膜中,腱索(chordae tendineae)要么被撕裂或损坏,要么长度不当。当腱索太长,太短,或被损坏时,腱索连接到其上的相应的三尖或二尖瓣膜通常可能不能适当闭合。例如,撕裂或太长的腱索会使瓣膜脱垂,其中一个或多个瓣膜叶向后摆动超出它们适当闭合的位置。这可导致回流,这是由于瓣膜功能不全导致的从心室到心房的血液逆流。当瓣膜允许这样的逆向流动进入心房时,相应的心室必须抽吸得更用力以在整个身体内循环血液,这进而产生充血性心力衰竭。
【0008】过去已经实践了修复和/或更换功能障碍的腱索。这样的修复技术通常复杂,原因是在接近手术位置,在识别功能障碍的腱索,和在判断被修复和/或更换腱索的适当长度中存在困难。
【0009】另一种瓣膜修复方法涉及手术切除所有或部分特定心脏瓣膜的一个或多个瓣膜叶。在这样的手术过程中,损伤部分的瓣膜叶被切除,剩余部分的瓣膜叶被缝合到一起从而修复除去损伤部分导致的开口。该过程绷紧瓣膜叶,这可防止瓣膜脱垂并因此改善瓣膜功能。这样过程的例子是二尖瓣膜的段切除,其中后叶脱垂部分被切除,且剩余部分被缝合到一起从而绷紧瓣叶。
【0010】脱垂区域的四边形切除是相对普通的瓣膜修复技术,该技术已经展示出良好的效果。然而,该手术相对复杂并可能要求外科医生在手术过程中做大量实时决定,包括判断切除多少,是否执行瓣环褶皱从而闭合间隙,等等。
【0011】二尖瓣修复的目标是恢复良好的结合表面从而确保满意的瓣膜功能。因为瓣叶组织是定义瓣膜结合表曲的主要组成部分,优选尽可能多地保留瓣叶组织,这与切除其中相当多的部分对立。保留尽可能多的组织保持解剖和动力关系,允许力和应力更好地分布在瓣膜组件上。然而,为了保存瓣叶组织,有功能障碍的瓣膜的其他方面可能必须修改和/或治疗,如瓣环的形状和任何损伤的索带。
【0012】因此,需要改进的设备、系统和方法修复有功能障碍的心脏瓣膜,包括二尖瓣。本发明满足这些需求中的一个或多个。
发明内容
【0013】本申请通常是对其在二尖瓣修复中应用说明的,二尖瓣调节血液从左心房(LA)流到左心室(LV)。然而,本发明也可用来修复其他瓣膜,如三尖瓣或动脉瓣修复。
【0014】本发明包括使用更换索带(chordae)校正二尖瓣脱垂,如扩展的新索带(neochordae)缝合(如聚四氟乙烯(e-PTFE))而不切除瓣叶,或切除的瓣叶最小,从而悬挂后叶的自由边缘。一个或多个更换索带缝合可穿过乳头肌并穿过瓣叶,并可调整到适当长度,且固定在适当位置。所需的更换索带的数量和长度取决于特定病人的需要,包括瓣环的特征,瓣膜叶和现有的索带。
【0015】本发明可包括心脏瓣膜成形术环的应用。瓣膜成形术环可再成形心脏瓣环至所需形状,和/或防止心脏瓣环进一步不需要的变形。瓣膜成形术环也可固定瓣环在心肌收缩的位置。
【0016】本发明也可包括对瓣膜叶自身的改进。例如,外科医生可缝合瓣膜叶上的缺口,特别在缺口相对深的位置和瓣膜成形术环被用来固定瓣环在心肌收缩位置。
【0017】本发明的多个方面可独立或结合使用来修复瓣膜。本发明可应用至多种方式的瓣膜修复,包括开放手术方法,如胸骨切开术,或微创方法,如经皮或肋间手术。标准的心房切开术方法通常用于二尖修复过程。
【0018】本发明的其他特征和优点可从下面详细说明,结合附图显然看出,附图通过例子图解说明本发明的原理。
附图说明
【0019】图1描绘二尖瓣膜的顶视图,其中二尖瓣膜被暴露供外科医生查看和分析;
【0020】图2描绘外科医生分析的二尖瓣膜的顶视图;
【0021】图3描绘二尖瓣膜的顶视图,其中二尖瓣膜后叶的脱垂区域被分析;
【0022】图4描绘通过二尖瓣膜的顶视图,其中放置有穿过乳头肌的人工索带缝合;
【0023】图5A描绘通过二尖瓣膜的顶视图,其中放置有穿过后叶自由边缘的人工索带缝合;
【0024】图5B描绘二尖瓣膜的侧视图,其中放置有穿过后叶自由边缘的人工索带缝合;
【0025】图6A是二尖瓣膜和乳头肌的侧视图,其中在没有显著过多组织处放置和系有人工索带缝合;
【0026】图6B是二尖瓣膜和乳头肌的侧视图,其中在有显著过多组织处放置和系有人工索带缝合;
【0027】图7是二尖瓣膜和乳头肌的侧视图,其中系有人工索带缝合;
【0028】图8是二尖瓣膜顶视图,其中缝合应用到后叶缺口;
【0029】图9是二尖瓣膜顶视图,其中植入瓣膜成形术环并具有盐水注射器;
【0030】图10是按照本发明实施例的导引装置的顶部透视图;
【0031】图11是图10中导引装置的侧面透视图;
【0032】图12是按照本发明实施例的图10-11中导引装置的顶视图,其设置在二尖瓣膜环上或二尖瓣膜环内;
【0033】图13是按照本发明实施例的图10-11中导引装置的侧面透视图,部分截面视图,其中导引装置设置在二尖瓣膜环上或二尖瓣膜环内;
【0034】图14A-14C是按照本发明实施例的导引装置的部分截面的侧视图;
【0035】图15是按照本发明实施例的导引装置的部分截面的侧视图;
【0036】图16A和16B是按照本发明实施例的导引装置的部分截面的侧视图;和
【0037】图17A和17B是按照本发明实施例的导引装置的部分截面的侧视图。
具体实施方式
【0038】图1描绘心脏10,其中左心房壁14中有切口12,通过该切口12暴露二尖瓣16供手术过程中查看。心房壁切口12用一个或更多个牵开器18保持打开,使外科医生能够完整查看从而分析二尖瓣16。注意,查看可直接实现,如打开胸腔和/或开放心脏手术方法的通常情形那样,或间接通过内窥镜或其他可视化装置,如微创手术过程中那样。在图1中所示的暴露处,缝合20(如3-0缝合)在下腔静脉22周围和其下通过,然后在约二尖瓣环28后面1.5cm处的位置26形成通过左心房内皮24的浅通道(即采用表面咬合口)。注意,在所描述的特定实施例中,缝合在瓣环28上约5点钟的位置通过左心房内皮18,而瓣环上正午时间的位置是前叶A中部22,而6点钟的位置是后叶P的中部24),然后在下腔静脉16的后面和下面绕回。通过对缝合20应用轻柔拉力,即可实现所需的暴露。
【0039】一旦所需的二尖瓣膜16暴露和/或参看实现,则可执行对二尖瓣膜结构的透彻的外科分析。字母数字编码常用于指示二尖瓣膜区域16,该编码用在本申请及其附图中。字母P和A分别指后叶P和前叶A。每叶也都被分成3个部分,叶的前横(antero-lateral)部分以数字1表示,中间部分以数字2表示,后中部(postero-medial)以数字3表示。后叶部分通常因为它们的形状而被称为贝状体(scallop),前横贝状体被指示为P1,中贝状体被指示为P2,而后中贝状体被指示为P3。前叶的相应(即相对)部分被分别指示为A1,A2和A3。
【0040】通常,后叶P的前横贝状体P1不会脱垂并可用作其他段比较的参考点。借助一个或多个神经钩34或类似装置,如图2所示,P1的自由边缘与A1的自由边缘或其他部分比较,然后与A2,P2,A3,和P3比较。注意该比较顺序仅是例子,且本发明不局限于该特定顺序。对整个二尖瓣使用这类逐步探查,可以实现对二尖瓣良好的三维理解。该分析可判断和/或识别脱垂或其他瓣膜功能障碍。在图2所示的特定的二尖瓣16中,分析揭示后叶P的脱垂36,其位于P2中,其中由于一个或更多个撕裂的索带38(图3所不),后叶中贝状体P2的自由边缘重叠(override)前叶中部A2的自由边缘。注意外科手术瓣膜分析的结果可与术中超声的发现物相比较。
【0041】一旦识别到后叶P的脱垂区域(或多个区域),一个或更多个支座缝合(stay suture)40(如2-0支座缝合)是绕正常索带通过的,和/或通过后叶P自身(如图3描述),在后叶P的脱垂区域36的每一侧从而描绘病理区。轻微按压这些支座缝合40可提供脱垂区36和撕裂索带38的暴露,如图3所示。
【0042】脱垂区域36的分析针对组织的两个主要方面:组织的质量,和组织的量/数量(这相应于脱垂区域中后叶P的高度)。在考虑组织的质量时,应该评估粘液性变的存在和程度。操作的目标是构建垂直支持体(buttress),其中表面区域通常是平滑和平整的,从而确保均匀的结合表面。粘液性变可能太不规则,产生膨胀袋(bulging pocket),这使得结合表面不均匀且不规则。在这样的情形中,可能需要切除从而消除这类不均匀区域。粘液性变也可能在后叶P的底部过多,减小二尖瓣环28和后叶P之间结合的柔韧性。这可将结合表面向前移位,这样增加了二尖瓣前叶收缩期前向运动(SAM)的危险性。在二尖瓣前叶收缩期中,二尖瓣前叶被“拉”到左心室流出口时发生SAM,这可引起通过二尖瓣到左心房的渗漏。
【0043】在评估组织的量时,外科医生将评价后叶P的高度。当后叶P的高度超过2厘米时认为有过多的组织。注意这样的情形很重要,因为其将影响要植入的人工索带的长度。
【0044】为了更好地查看和/或接触索带42和乳头肌44a,44p的区域,一个或更多个前支座缝合46,如2-0支座缝合绕前叶A的索带42通过,如图4所示。根据具体应用和病人,两个这样的缝合46是足够的。当与轻柔地拉动后支座缝合40并因此拉动后叶P结合时,轻柔地拉动这些前支座缝合46可提供良好查看和/或接触左心室腔和乳头肌44a,44p。然后,可相对方便地使用镊子48抓住前乳头肌44a从而增加其暴露及稳定性。索带更换缝合50a,如4-0 e-PTFE的衬垫(mattress)缝合是通过前乳头肌44a顶部52a的纤维化部分设置的。在所示实施例中,索带更换缝合50a是用弯曲的针54和持针器56设置的。通常缝合50a的离开点需要向脱垂区域36取向。然后系住索带更换缝合50a,这可能涉及3到4个结,都在前乳头肌44a上。然后可对后乳头肌44p重复同样的操纵,由此索带更换缝合50p(图5A中所示)穿过后乳头肌44p顶部52p的纤维化部分。
【0045】为了不妨碍和保护瓣下结构(subvalvular apparatus)(如索带等),通常需要将索带更换结构50a,50p穿过乳头肌头(一个或多个)设置,该乳头肌头固定要更换和/或要修复的病变的索带。索带更换缝合50a,50p的实际更换取决于具体应用,包括特定的病人和外科医生。主要原理是人工索带被安全固定。
【0046】脱垂通常都是局部的,如所示后叶P的中贝状体P2的局部脱垂36。然而,包括瓣叶其他部分异常的广泛的损坏或其他因素可使修复变复杂。例如,如果后叶P的脱垂区域36仅大于中贝状体P2的中部,或如果存在其他损坏和/或方面,安装额外的人工索带可能需要再悬挂脱垂区域36。
【0047】随着索带更换缝合50a,50p通过并经结58a(58p未示出)系到所需的乳头肌或肌体44a,44p,然后索带更换缝合50a,50p通过瓣叶自由边缘(一个或多个)提起,在所示实施例中是后叶P。在提起索带更换缝合50a,50p中,要注意避免将索带更换缝合50a,50p缠绕到自身无病索带42或其他瓣下结构。在图5A和图5B的实施例中,一个缝合50a位于P2的中间和P1-P2之间的缺口之间。(另一个缝合50p位于P2的中间和P2-P3之间的缺口之间,虽然该过程在图5A和图5B中没有示出。)
【0048】在图5B中更清楚示出的实施例中,双臂缝合50a在自由边缘62处和/或邻近自由边缘62处通过后叶P的耳状侧60,在此处连接自然索带,然后回绕到耳状侧60约远离自由边缘62四到五毫米。缝合50a的两个臂64,66之间的距离在它们通过后叶P时可接近3毫米,从而避免褶皱和/或损伤叶组织,该损伤可能会损坏结合表面的平滑度和规则性。
【0049】注意图5A和5B中所示的过程仅示出索带更换缝合50a系结和连接到后叶P和前乳头肌44a。如果需要,并根据具体应用,可重复该过程从而连接索带更换缝合50p(如果有)至后叶P和后乳头肌44p,或连接到任何瓣叶和适当的乳头肌。
【0050】为了确保适当的瓣膜操作,由索带更换缝合50a,50p形成的人工索带可在适当的长度处打结。在图6A和6B所示的实施例中,后叶P的支座缝合已经除去,因此叶自由边缘62自由移动。
【0051】调整人工索带长度至适当长度应包括考虑任何过度的叶组织,这些过度的叶组织被当作术后SAM的风险因素。结合表面朝向心室留出通道(ventricular outflow tract)的前移位被认为是SAM的风险因素。为了减小SAM的风险,后叶P的脱垂的校正度应该是结合表面保持垂直和靠后,平行于左心室的后壁并远离左心室流出道。换句话说,如果多余组织大,则人工索带应更短。
【0052】根据具体应用,目标可不仅包括脱垂的校正,而且还包括后叶转换为垂直支持体,前叶与它并置(apposition)贴着从而产生适当的密封并防止瓣膜渗漏。为了实现该目标,需要防止后叶的自由边缘朝前移动到左心室留出通道。
【0053】选择人工索带的长度以补偿后叶P的任何多余组织。如果没有多余组织,那么人工索带长度被选择以使后叶P的自由边缘62达到瓣环28的平面70的水平,如图6A所示。如果有多余组织,那么选择人工索带长度从而使后叶P的自由边缘62达到较低的水平72,如图6B所示。根据具体应用和各因素,如后叶P的高度,较低的水平72通常在瓣环28的平面70下面的5毫米和8毫米之间的深度73处。一旦后叶自由边缘62达到所需水平,则用一个或多个结74将索带更换缝合50a,50p系到后叶P的耳状侧60。在一个实施例中,可能需要三到四个结,虽然根据具体应用,也可使用其他数目个结。
【0054】注意,特定的方式可以有变化,其中根据具体应用,索带更换缝合位于和/或固定在瓣叶。例如,在图5B到图6B所示的实施例中,索带更换缝合50a从处于或邻近自由边缘的后叶P的耳状侧60通过,然后以距自由边缘约3毫米的距离通过后叶P绕回。然后,所示的索带更换缝合50a用标准正方形打结方法系住。然而,根据具体应用和特征,如特定叶组织的强度,这些缝合位置和距离可以改变。解决缝合更换和固定的关键问题是索带更换缝合(一个或多个)应保持。
【0055】图7示出索带更换缝合50a再次通过后叶P,然后系在后叶P的心室侧68。根据具体应用和涉及的缝合(如,如果索带更换缝合(多个)是相对滑的材料,如e-PTFE),总的需要10到12个结来系住索带更换缝合,这可留有相对显著的余量。在心室侧68结最后一个结或多个结可防止由于最后结的显著余量导致的结合表面上过度的不规则性,而且避免瓣叶P沿索带更换缝合的任何移动,该移动可在瓣叶P和/或更换索带缝合上产生不必要的重复张力或其他应力。
【0056】大多数二尖瓣具有在P1和P2之间自然发生的折痕或缺口,以及在P2和P3之间具有另一个缺口。如果P1和P2之间以及P2和P3之间缺口中的一个或两个相对深,则可能影响将后叶转换为相对平滑和规则垂直支持体的目标。在自然和未治疗的二尖瓣中,这些缺口用于生理目的,使得后叶能够稍微扩展从而顺应瓣环的心脏舒张膨胀而无张力。然而,如果瓣环通过植入瓣膜成形术环固定到心脏收缩位置,则缺口将不再充当它们有用的角色,并可能影响适当的瓣环功能。例如,缺口可引起由于不规则结合表面导致的残余渗漏。因此,当缺口相对深和/或要植入瓣膜成形术环时,需要缝合缺口。图8示出二尖瓣16,其中安装索带更换缝合50a,50p来产生更换索带。二尖瓣16在P1和P2之间具有缺口74,和在P2和P3之间具有另一个缺口76。缺口74,76已经以缝合78,80,如5-0单纤维丝穿行的缝合闭合。
【0057】通过将人工索带放置在适当位置(如果需要,缝合缺口),可安装瓣膜成形术环。在图9所示的二尖瓣16中安装的实施例中,环固定缝合82(如2-0 breaded缝合)穿过二尖瓣环28后进入瓣膜成形术环84。环固定缝合82以不妨碍自身瓣膜16所需几何形状的方式设置。在所示实施例中,四个缝合82设置在两个接合处86之间的前叶A的水平,且剩余缝合82邻近后叶P设置。前叶A的中部30相应于瓣膜成形术环84的中部88,从而避免二尖瓣16从所需的几何形状变形。
【0058】瓣膜成形术环16的作用不仅是减小二尖瓣环28的尺寸,而且再塑二尖瓣16的形状,二尖瓣通常由于二尖瓣机能不全的后果和/或缘故而变形。在心脏收缩位置固定二尖瓣16,瓣膜成形术环84将防止任何进一步的膨胀。瓣膜成形术环84的尺寸是按照多种因素选择的,如前叶表面区域,三角形之间距离(intertrigonal distance)等。
【0059】在植入环后,在手术位置闭合前,可测试修复的结果。在图9中,二尖瓣16是通过注射器92将盐水90注入到左心室测试的。两个重要目标是确认无回流并判断闭合线外观。闭合线通常优选是对称的,靠近环,并平行于环的后面。后闭合线表明结合表面是远离心室流出道的。
【0060】在左心房闭合并恢复正常血液动力功能后,超声波心动图(echocardiographic)分析或其他心功能评估可判断最终的质量。无回流和自由(无障碍)流出道表明成功修复。此外,可测量结合表面的高度,成功修复后,它通常在12毫米和18毫米之间。对于成功的治疗,超声波心动图分析通常表明后叶很少移动或不移动,垂直挂在环上并形成支持体,前叶并置于该支持体。
【0061】再次参考图6A和6B,获得索带更换缝合50a(50p未示出)所需长度对实现二尖瓣16的适当修复是重要的。指示打结缝合的环平面或其他水平的导引对外科医生或安装索带更换缝合的其他人员可能是有帮助的。这样的导引装置100的实施例在图10和图11中示出。所示的导引装置100包括通用环状主体102,在所示实施例中,该主体102的形状类似被治疗的瓣环。导引装置100经配置设置在被治疗的二尖瓣上或其中。导引装置100包括一个或多个缝合锚(suture anchor)104,其经配置接受缝合从而允许导引装置100临时缝合在二尖瓣环上或其中。导引装置100也包括形式为横杆106的大致水平的导引元件。在所示的特定实施例中,横杆106在大致为环状的主体102下面约5毫米的深度107处被固定到导引装置100,但其他横杆深度也在本发明的范畴内。横杆深度的选择取决于具体应用,包括诸如更换索带要固定到其上的瓣叶高度的因素,等等。0和8毫米之间的深度对本发明有特别意义。
【0062】横杆106经横杆释放机构固定到导引装置100,该释放机构包括第一垂直条110和第二垂直条112。垂直条110,112每个都包括在导引装置100的大致为环状的主体102上面延伸的近端部分114,116。每个垂直条110,112也包括固定到横杆106的远端部分118,120。
【0063】一个垂直条110在其远端部分118经插销122形式的铰链固定到横杆106。其他的垂直条112包括孔124,该孔经配置滑动地接收横杆106的末端。两个垂直条110,112都通过至少部分柔韧的连接件126,128固定到导引装置100的大致为环状的主体102。通过在垂直条110,112的近端部分114,116向内按压(即,通过向相对的垂直条的近端部分按压一个垂直条的近端部分),通过绕连接件126,128旋转垂直条110,112,垂直条110,112的远端部分118,120被迫分开。随着远端部分118,120移动分开,横杆106被推出孔124,且然后被释放从而绕插销122旋转,如图11所示。
【0064】在图10和11所示的实施例中,由横杆106形成的“瓣膜下”组件及其支架(即垂直杆下部118,120)具有长度129,该长度129小于导引装置100的大致为环状的主体102的最大宽度130。横杆106也由垂直杆110,112保持在从环状主体102的周边稍微向内的位置。环状主体102通常经配置匹配要治疗的瓣环的形状。如图12-13所示,横杆106和垂直元件下部118,120“向内”定位允许横杆106通过瓣环28并在瓣叶A,P之间的位置,该位置促进导引打结更换索带缝合的适当长度。
【0065】在图12和13所示的实施例中,在打结索带更换缝合50a,50p至瓣膜后叶P之前,导引装置100设置在瓣环28上或其中。根据具体应用,在索带更换缝合50a,50p已经固定到各乳头肌44a(44p未示出)之后,但在索带更换缝合50a,50p被牢固地系到瓣膜后叶P之前,导引装置100可设置在瓣环28上或其中。导引装置100设置在瓣环28上,垂直杆110,112的远端部分118,120延伸穿过瓣环28并进入瓣膜下区域。这将向下延伸到瓣环28中的横杆106定位到心室区所需的深度107处,根据具体应用和诸如后叶组织的多余程度的问题等,该深度可在瓣环28的平面70的0毫米到10毫米之间。在所描述的具体实施例中,导引装置100设置在瓣环28上或其中,因此环状主体102通常平行于瓣环28的平面70。对于所示具体导引装置100,其具有大致平行于环状主体102的横杆106,横杆106将因此大致平行于瓣环28的平面70设置。
【0066】由于导引装置100处在所需位置,外科医生或其他用户可用一个或更多个通过缝合锚104的支座缝合132临时固定导引装置主体102至瓣环28。
【0067】随着索带更换缝合(多个)系到乳头肌(多块),外科医生或其他用户将继续将索带更换缝合系到瓣叶,如前面图5A到图7所示。如图12和13所示,导引装置100的横杆106用作索带更换缝合50a,50p系到瓣叶的适当高度的指示器。如图13所示,外科医生可传递横杆106任一侧的每个更换缝合50a(50p未示出)的第一臂64a(64p未示出)和第二臂66a(66p未示出),然后在缝合中打一个或多个结58a(58p未示出),以便将横杆106保持在缝合结58a(58p未示出)和后瓣叶P之间。随着索带更换缝合50a(50p未示出)以所需的长度固定的后瓣叶P,可除去导引装置100和横杆106。在图10-13所示的装置中,用户可将垂直杆110,112的近端部分114,116挤压到一起,从而从一个垂直杆116释放横杆106并允许横杆106从结58a(58p未示出)和后瓣叶P之间滑出。然后,用户可将另外的结尾结(finishingknot)打在索带更换缝合50a,50p处,如前面图7和图8所示那样,从而使得到瓣叶P的连接更安全和/或永久,并吸收由于除去横杆106导致的索带更换缝合50a,50p中的任何松弛。
【0068】根据具体应用,该装置可包括具有可调整深度107的横杆106。例如,在图14A-14C所示的实施例中,垂直杆110,112通过连接件134固定到主体102,该连接件允许垂直杆110,112相对主体102提升和/或降低。一个或多个连接件134可包括锁定设备(未示出),一旦垂直杆110,112已经滑到所需位置(多个),该锁定设备在该位置固定垂直杆110,112。锁定机构可以是本领域公知的用于将滑动元件相对固定元件锁定在适当位置的许多这类设备和/或方法中的任意一种。因此用户可选择设置横杆106的所需深度,上下滑动垂直杆110,112中一者或两者直到横杆106处于所需位置,锁定连接件134从而固定垂直杆110,112和横杆106在所需位置,且进而用导引装置100判断索带更换缝合(多个)的适当长度。在图14A中,横杆深度108相对小,而在图14B中,横杆深度108增加。在图14A和14B中,所示横杆106大致平行于环状主体102。然而,通过滑动垂直杆110,112至不同深度108a,108b,如图14C所示,横杆106可实现一定角度的构型。可选择这样带角度的横杆构型用于不同更换索带要求不同长度的情形。如图14C所示的装置100,具有通常与环状主体102不平行的横杆106。将具有环状主体102的图14C中装置100设置在瓣环上或其中,并平行于瓣环平面(以类似的方式将图10和11中“平行杆”装置设置到图12和13所示的位置)将导致横杆106相对瓣环平面大致不平行。
【0069】更换索带参考元件,在图10-11和图14A-14C中是横杆106,可包括非柔性元件或基本柔性元件。在图10-11和14A-14C中,横杆106是基本非柔性杆。也可使用柔性元件,如柔性杆或柔性缝合。例如,在图15中,缝合线136用作横杆参考元件。横杆缝合136在垂直杆110,112之间被相对紧密地牵引,该垂直杆延伸从而形成平行设置在导引装置环状主体102下面的参考线。在所示具体实施例中,横杆缝合136经延伸通过缝合孔138然后以结140系住而被固定到垂直杆110,112。使用中,一旦更换索带缝合(多个)打结,且需要除去导引装置和横杆缝合,横杆缝合可简单地由外科医生或其他用户以手术刀切去,然后,除去的导引装置且横杆缝合的剩余端从索带更换缝合结与后叶之间拉出。
【0070】在本发明的另一实施例中,可使用多个横杆,外科医生在使用设备之前除去不想要的横杆。例如,在图16A和16B所示的实施例中,多个缝合线136a,136b,136c设置在垂直元件110,112上的不同深度处。导引装置100包括深度标记142a,142b,142c,这些标记指示各缝合杆136a,136b,136c的深度。图16A和16B中所示的深度标记142a,142b,142c是简单的线或凹口(notch),但根据具体应用,也可使用或补充使用其他深度标记,如数字,字母或其他标记。在放置导引装置100在瓣环上或其中之前,外科医生或其他用户可选择所需的深度并除去这些不在所需深度处的缝合杆,同时保留在所需深度处的缝合杆。在图16B中,用户已经通过切割或其他方法除去最高的缝合杆136a和最低缝合杆136c,从而将中间缝合杆136b保留在适当位置用作更换索带参考元件。注意,使用可除去杆元件不限于缝合杆,也可使用通用的刚性杆,等等,其经配置选择性地由外科医生或其他用户除去。
【0071】图17A-17B描绘本发明的又一个实施例,其中用户选择所需深度并在所需深度安装横杆或其他更换索带参考元件。图17A-17B的装置100包括两个垂直杆110,112,每个都具有沿垂直杆110,112的至少一部分长度的几个孔138或其他缝合保持元件。深度标记142也可沿垂直杆110,112的长度放入从而指示任何横杆缝合的“深度”,该横杆缝合可通过特定孔(即,每个孔与通过导引装置大致环状周体并表示瓣环平面的平面的距离)打结。外科医生或其他用户可这样选择所需深度,判断哪个孔相应于所需深度,然后缝合通过一个垂直杆中所需孔至第二垂直杆中所需孔。外科医生或其他用户可在结140这样打结缝合线,或通过其他本领域公知的保持方法在每个垂直杆110,112中所需孔打结,从而产生如图17B所示的具有横杆缝合136的装置,该横杆在所需深度处的垂直杆110,112之间延伸。每个垂直元件110,112中所选孔可在相同水平,如图17B所示,从而提供大致平行于环状主体102的横杆缝合136。可替换地,从每个垂直元件中所选的孔可在不同水平,从而提供与环状主体102成一定角度(即,不平行)的横杆缝合。这样的实施例将与图14C中描述并参考其讨论的实施例具有类似的特征,用途和应用。
【0072】在上述讨论的实施例中,讨论和附图大部分针对更换二尖瓣后叶的索带。然而,本发明也可用来更换其他索带,如二尖瓣前叶索带或其他瓣膜索带。
【0073】虽然所示和讨论的特定实施例涉及开放式手术方法,但本发明也可应用于微创方法,包括经皮方法(包括通过循环系统进入治疗位置)和肋间方法(包括通过心脏壁,包括心尖进入治疗位置)。
【0074】虽然本发明可无需切除任何瓣叶执行,根据心脏瓣叶的状况,某些切除可能是必须的。本发明可减少任何切除需要和/或任何切除程度,但可能需要与某些切除结合,特别是瓣叶具有大量的多余量的组织时。
【0075】虽然已经参考具体实施例描述了本发明,但可以理解,在不偏离本发明的范畴或本发明的概念内,能够做出多种改变和额外的变化,并用等效物替代其中元素。例如,虽然本发明是结合索带修复和/或更换具体讨论的,这在需要修复类似结构的其他领域也具有可用性。此外,可做出许多修改来使特定的情形或材料适应本发明的教导,而不偏离本发明的基本范畴。因此,本发明不限于这里描述的具体实施例,但本发明将包括落在所附权利要求范畴内的所有实施例。
Claims (30)
1.一种修复心脏瓣膜的设备,其包括:
支撑体,所述支撑体定义通过它的参考平面,并经配置放置在心脏瓣环上或心脏瓣环内;
第一参考元件,所述第一参考元件固定在所述支撑体上并设置在与所述支撑体参考平面距离3毫米到15毫米处。
2.如权利要求1所述的设备,其中所述第一个参考元件包括细长的装置,该装置具有第一端和第二端,其中所述第一端在与所述支撑体参考平面第一距离处固定到所述支撑体上,而第二端在与所述支撑体参考平面的第二距离处固定到所述支撑体上。
3.如权利要求2所述的设备,其中所述第一距离基本等于所述第二距离。
4.如权利要求3所述的设备,其中所述第一距离大于所述第二距离。
5.如权利要求2所述的设备,其中所述第一参考元件被配置为当所述支撑体放置在所述心脏瓣膜的瓣环上或瓣环内时安装在心脏瓣膜的邻近瓣叶之间。
6.如权利要求2所述的设备,其中所述第一参考元件包括细长杆。
7.如权利要求2所述的设备,其中所述第一端可释放地固定在所述支撑体上。
8.如权利要求2所述的设备,其中所述第一端经滑动连接件而连接到所述支持体上。
9.如权利要求8所述的设备,其中所述滑动连接进一步包括锁定机构。
10.如权利要求2所述的设备,其中所述第一参考元件包括缝合线。
11.如权利要求2所述的设备,其中所述设备经配置提供所述第一距离和所述第二距离之间的变化。
12.如权利要求2所述的设备,进一步包括:
第二参考元件,所述第二参考元件固定到所述支撑体上并以与所述支撑体参考平面相距3毫米到15毫米的第二参考距离设置,其中所述第二参考距离不同于所述第一参考距离。
13.如权利要求12所述的设备,进一步包括:
第三参考元件,所述第三参考元件固定到所述支撑体上并以与所述支撑体参考平面相距3毫米到15毫米的第三参考距离设置,其中所述第三参考距离不同于所述第二参考距离和所述第一参考距离。
14.一种用于修复心脏瓣膜的设备,其包括:
支撑体,所述支撑体定义通过它的参考平面,并经配置放置在心脏瓣环上或心脏瓣环内;
第一细长元件,其从所述支撑体在远离支撑元件参考平面的方向延伸到至少3毫米的第一元件长度;和
第二细长元件,其从所述支撑体在远离支撑元件参考平面的方向延伸到至少3毫米的第二元件长度。
15.如权利要求14所述的设备,其中所述第一细长元件包括多个第一缝合连接点,所述第一缝合连接点沿所述第一细长元件的长度设置在不同位置。
16.如权利要求15所述的设备,进一步包括:
指示从一个或多个所述第一缝合连接点到所述支撑元件参考平面距离的标记。
17.如权利要求15所述的设备,其中所述第二细长元件包括多个第二缝合连接点,所述第二缝合连接点沿所述第二细长元件的长度设置在不同位置。
18.如权利要求17所述的设备,进一步包括:
指示从一个或多个所述第二缝合连接点到所述支撑元件参考平面距离的标记。
19.如权利要求15所述的设备,其中每个所述第一缝合连接点包括通过所述第一细长元件的孔。
20.如权利要求17所述的设备,进一步包括:
第一缝合线,其从所述第一缝合连接点中第一点延伸到所述第二缝合连接点中第一点。
21.如权利要求20所述的设备,进一步包括:
第二缝合线,其从所述第一缝合连接点中第二点延伸到所述第二缝合连接点中第二点。
22.如权利要求21所述的设备,进一步包括:
第三缝合线,其从所述第一缝合连接点中第三点延伸到所述第二缝合连接点中第三点。
23.一种修复心脏瓣膜的方法,心脏瓣膜具有带相应的环平面的心脏瓣环,该方法包括:
在第一连接点固定第一缝合线到第一乳头肌,其中所述第一乳头肌位于邻近所述心脏瓣膜的心脏腔室中;
将第一缝合线的一部分通过心脏瓣膜的第一心脏瓣叶;
提供索参考元件;
在与心脏瓣环的环平面相距至少3毫米的位置处,在心脏腔室内定位所述索参考元件;
固定所述第一缝合线至第一心脏瓣叶,其中所述第一缝合线固定在邻近所述索参考元件位置处的第一心脏瓣膜。
24.如权利要求23所述的方法,其中固定所述第一缝合线至所述第一心脏瓣叶包括将所述缝合线绕过所述索参考元件,并在所述第一缝合线打结以便所述索参考元件位于所述结和所述第一心脏瓣叶之间。
25.如权利要求23所述的方法,其中所述心脏瓣膜包括二尖瓣,所述心脏瓣叶包括第一部分、第二部分和位于第一部分及第二部分之间的中间部分,且所述方法进一步包括:
缝合所述第一部分和所述瓣叶中间部分之间的第一表面缺口;以及
缝合所述第二部分和所述瓣叶中间部分之间的第二表面缺口。
26.如权利要求23所述的方法,其中提供所述索参考元件包括:
提供主支撑体,该主支撑体经配置设置在心脏瓣环上或心脏瓣环内,所述主支撑体定义支撑体平面;
提供参考元件,该参考元件可滑动地固定到所述设备上,以便从所述参考元件到所述支撑体平面的距离可通过向和/或远离所述支撑体平面滑动所述参考元件而改变。
27.如权利要求26所述的方法,其中提供所述索参考元件包括:
相对所述支撑体平面滑动所述参考元件至所需位置。
28.如权利要求23所述的方法,其中提供所述索参考元件包括:
提供主支撑体,该主支撑体经配置放置在所述心脏瓣环上或所述心脏瓣环内,所述主支撑体定义支撑体平面;
提供多个参考元件,所述多个参考元件被固定到所述设备,所述多个参考元件中的每个参考元件被设置在离所述支撑体平面不同距离处。
29.如权利要求28所述的方法,其中提供所述索参考元件包括:从
所述多个参考元件中选择所述索参考元件;以及
除了所述索参考元件外,除去所有参考元件。
30.如权利要求23所述的方法,其中提供所述索参考元件包括:
提供主支撑体,该主支撑体经配置放置在所述心脏瓣环上或所述心脏瓣环内,所述主支撑体定义支持体平面;
提供第一元件,其延伸远离所述主支撑体平面,所述第一元件包括多个第一缝合连接点;
提供第二元件,其延伸远离所述主支撑体平面,所述第二元件包括多个第二缝合连接点;
固定缝合线的第一端至所述第一缝合连接点中的一个;以及
固定所述缝合线的第二端至所述第二缝合连接点中的一个。
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- 2006-06-27 JP JP2008518506A patent/JP5279124B2/ja not_active Expired - Fee Related
- 2006-06-27 EP EP06785615.3A patent/EP1903990B1/en not_active Not-in-force
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Also Published As
Publication number | Publication date |
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EP1903990B1 (en) | 2015-02-25 |
JP5279124B2 (ja) | 2013-09-04 |
CA2609991C (en) | 2013-09-17 |
EP1903990A1 (en) | 2008-04-02 |
CA2609991A1 (en) | 2007-01-04 |
US8685083B2 (en) | 2014-04-01 |
WO2007002627A1 (en) | 2007-01-04 |
CN101208058B (zh) | 2010-08-25 |
US20070123979A1 (en) | 2007-05-31 |
JP2009511088A (ja) | 2009-03-19 |
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