CN101495049A - 胸镜心瓣膜修复方法与装置 - Google Patents

胸镜心瓣膜修复方法与装置 Download PDF

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CN101495049A
CN101495049A CNA2006800026452A CN200680002645A CN101495049A CN 101495049 A CN101495049 A CN 101495049A CN A2006800026452 A CNA2006800026452 A CN A2006800026452A CN 200680002645 A CN200680002645 A CN 200680002645A CN 101495049 A CN101495049 A CN 101495049A
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G·斯佩茨雅利
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Abstract

一种进行心瓣膜胸镜修复的器械，该器械包括：轴，用于延伸穿过胸腔并进入心脏腔室，从而到达需要修复的瓣膜。可操纵轴上的可移动尖端以俘获瓣膜小叶，并且可操纵针以刺穿被俘获的瓣膜小叶并将缝线牵拉穿过该小叶。这样，缝线被紧固于瓣膜小叶，从心脏腔室取出器械而将缝线传送至心脏腔室外部。采用超声成像系统观察瓣膜操作可以确定，缝线以适当张力被锚定于心壁。

Description

胸镜心瓣膜修复方法与装置
相关申请的交叉引用
本申请建立在2005年1月21日提交的题为“胸镜(thorascopic)心瓣膜修复方法与装置”的美国临时专利申请第60/645,677号的基础上。
发明背景
目前，进行各种类型的外科手术来研究、诊断和治疗心脏和胸部大血管疾病。这些手术包括：二尖瓣、主动脉和其它心瓣膜的修复与置换，房间隔缺损和室间隔缺损的修复，肺部血栓切除术，动脉瘤的治疗、电生理映射和心肌膜消融，以及需要将介入设备引入心脏或大血管内部的其它手术。
采用目前的技术，这些手术多数需要大体开胸术，通常是正中胸骨切开术的形式，从而获取通往患者胸腔的通路。使用锯件或其它切割器械纵向切开胸骨，使相对的两半肋架的前部或腹部分离开来。从而形成通往胸腔的大开口，外科手术人员通过该开口直接肉眼观察并操作心脏及其它内含物。
外科介入心脏通常需要将心脏和冠状血管从动脉系统的其它部分分离开，并停止心脏功能。通常，通过胸骨切开术引入外部主动脉十字钳闭并将其应用于头肱动脉和冠状动脉口(coronary ostia)之间的主动脉，从而将心脏从动脉系统分离。然后通过直接注入冠状动脉口或通过主动脉根部穿刺以将心脏麻痹液注入冠状动脉，从而停止心脏功能。在一些情况下，将心脏麻痹液注入冠状窦从而逆行灌注心肌膜。患者置于心肺转流设备上以维持氧合血的外周循环。
本发明尤其感兴趣的是外科治疗心瓣膜的心内手术，尤其是二尖瓣和主动脉瓣。根据近期评估，美国医院里每年有79,000以上的患者被诊断患有主动脉和二尖瓣疾病。美国每年要进行49,000次以上的二尖瓣或主动脉瓣置换术以及大量心瓣膜修复手术。
可使用多种外科技术来修复患病或受损瓣膜，包括：瓣膜成形术(收缩瓣膜环)、四角切除术(使瓣膜小叶狭窄)、口角开大术(切开瓣膜连合以分离瓣膜小叶)、缩短二尖瓣或三尖瓣腱索、复置已分离的二尖瓣或三尖瓣腱索或乳头肌组织、以及瓣膜和环组织的脱钙作用。或者，可通过切除天然瓣膜的瓣膜小叶来置换瓣膜，并且通常通过使置换瓣缝合于天然瓣膜环而使置换瓣膜固定在瓣膜位置中。目前可使用多种类型的置换瓣膜，包括机械和生物假体、自体移植物和同种异体移植物，如Bodnar和Frater在Replacement Cardiac Valves 1-357(1991)中所述，其内容通过引用包括在此。心瓣膜疾病及其外科治疗的综述参见Kirklin和Barratt-Boyes，Cardiac Surgery 323-459(1986)，其全部内容通过引用包括在此。
通过左心房壁最容易到达位于左心房和左心室之间的二尖瓣，该左心房壁一般位于心脏后侧，即通过正中胸骨切开术暴露的心脏相对侧。因此，为了通过胸骨切开术到达二尖瓣，需翻转心脏使得左心房进入经胸骨切开术可到达的位置。然后在右侧肺静脉的前面、在左心房中制备开口或心房切口。通过缝合或回缩器械回缩心房切口，暴露出直接位于心房切口后侧的二尖瓣。然后，采用上文提到的技术之一来修复或置换瓣膜。
如果不希望正中胸骨切开术和/或心脏翻转操作，则可采用另一种到达二尖瓣的技术。在该技术中，在胸腔右后侧、通常是第五个肋间隙的区域中制备大切口。切除患者一个或多个肋，向外回缩切口附近的其它肋以形成通往胸腔的大开口。然后，左心房暴露在心脏后侧，在左心房壁中形成心房切口，通过心房切口可到达二尖瓣以进行修复或置换。
采用上述开胸技术，由正中胸骨切开术或右侧开胸术所提供的大开口使外科医生能够直接通过左心房切口看到二尖瓣，并且可将手置于胸腔中的心脏外部附近以操纵外科器械、去除离体组织、和/或通过心房切口引入用于附连在心脏内的置换瓣膜。然而，这些侵入性开胸术造成高程度创伤、并发症的风险大、住院时间延长，以及患者痛苦的恢复过程。而且，虽然心瓣膜外科手术对许多患者产生有益结果，但是可能受益于该手术的许多其它患者不能或不愿承受该技术的创伤或风险。
人体心脏内的二尖瓣和三尖瓣包括：孔口(环孔)、两个(对于二尖瓣而言)或三个(对于三尖瓣而言)小叶以及瓣膜下器官。瓣膜下器官包括多个腱索，它们将运动瓣膜小叶连接于心室内的肌肉组织(乳头肌)。腱索断裂或拉长将导致部分或全部小叶下垂，引起二尖瓣(或三尖瓣)反流。外科手术校正二尖瓣反流的常用技术是在瓣膜下垂区段和乳头肌之间植入人工腱索(通常4-0或5-0Gore-Tex缝线)。该操作通常通过正中胸骨切开术进行，并且需要用主动脉十字钳闭以实现心肺转流和麻痹停止心脏。
发明概述
本发明是在心脏搏动的同时进行侵入性最小的心脏瓣膜胸镜修复的方法和装置。更具体地说，该方法包括将器械插入穿过患者胸腔壁和心壁。器械远端带有可移动元件，操纵该元件来抓持并保持瓣膜小叶，同时针机构刺穿瓣膜小叶并使缝线环绕瓣膜小叶的一部分。将缝线与器械一起取出心脏，根据超声成像系统的观察，调节张力以实现最佳瓣膜功能之后，缝线在心尖打结。
除抓持和针机构之外，器械还包括光纤，提供瓣膜小叶是否适当抓持的直观指示。一组照明光纤在一组感应光纤附近围绕针机构终止于器械远端。感应光纤从器械传递来自远端的光，形成操作者观察到的图像。如果瓣膜小叶被适当抓持，来自照明光纤的光通过感应光纤从小叶瓣膜反射回去。另一方面，如果瓣膜小叶未被适当抓持，则感应光纤将见到血。
本发明的总的目的是提供能够修复心脏瓣膜而无需开心手术的器械和方法。在心脏搏动的同时将器械穿过胸腔壁开口进入心脏腔室。该器械能够修复心瓣膜，然后从心脏和胸腔退出。
优选实施方式的详细描述
在全身麻醉和双腔通气的情况下，安排并用布帘遮挡患者，从而实现进入右外侧、前侧和左外侧胸腔壁的足够大的外科手术通路(从一侧的腋后线到另一侧的腋后线)。如图1所示，将一个或多个胸腔镜检口经肋间隙插入左胸，并经上述口将器械10插入胸腔。或者，在腋前线的第五个或第六个肋间隙中进行左胸开胸小手术(3-5cm)。患者完全肝素化。左肺下陷之后，打开覆盖左心室14的叶尖12的心包膜并使其边缘悬吊于皮肤切割线。这提供了心尖的闭合通路。通过经食道或血管内超声心动图显象(图中未示出)的组合，并且使用构建在器械10内的光纤系统直接观察，提供对心内手术的指导，如下详细所述。将双侧纱布荷包缝线置于左心室的叶尖12上并在该位置制备穿刺切口。经该切口将外科手术器械10插入搏动心脏的左心室14中。
具体参考图2，可用器械10抓住二尖瓣16的脱垂区段，并将人工腱索18固定于其游离边缘。通过超声(echo)和直接光纤观察确保被植入的人工腱索18的准确定位，如下详细所述。然后，将器械10从左心室14中收回，将未附连端与它一起拉出。器械10和腱索18退出后，通过将荷包缝线系在左心室叶尖12中的切口周围以实现止血。如图3所示，新植入腱索18在直接超声多普勒观察下适当张紧并固定于心尖12的外部。就是说，在新植入的腱索18上施加张力，并在超声图像上观察修复瓣膜16的操作。调节张力直到反流最小。
虽然在上文的描述中植入了单个腱索18，还可植入其它腱索或缝线并使其以最佳张力附连于心尖12。在这种情况下，调节所有新植入的腱索18的张力直到实现最佳瓣膜功能。
如图4和5所示，用于实现上述操作的器械10包括刚性金属轴100，在该金属轴的胸腔外末端(近端)具有手柄120，使得可以操纵器械并将其导入适当位置。用于控制位于器械远端140的抓持机构和针机构的驱动机构也被安装在手柄120附近。如下所述，通过夹紧剪刀样抓持手柄120操纵抓持机构，通过移动上翻控制轴122操纵针机构。
位于器械10远端即胸腔内末端140的是抓持机构，可操纵该机构来握持脱垂的瓣膜小叶。如图6和7所示，在优选的实施方式中，该机构是在轴100的远端由一组杆162支持的尖端160。杆162在轴100内滑动，以在操纵剪刀样抓持手柄120时，尖端160在图6B和7所示的开放位置与图6A所示的闭合位置间运动。如下所述，二尖瓣膜小叶位于开放尖端160和轴100远端之间的间隙中，通过闭合尖端160以将瓣膜小叶夹紧于其间而俘获该二尖瓣膜小叶。
在形成于轴100中的针腔164内设置针180，针180连接于轴100近端的控制轴122。针机构180在内缩位置与延伸位置间滑动，在内缩位置时，它被容纳在轴100远端附近的管腔164中，在延伸位置时，在尖端处于闭合位置的情况下它可延伸进入滑动尖端160。结果，当瓣膜小叶被俘获在尖端160和轴100的远端之间时，通过移动控制轴122可使针从管腔164延伸以刺穿俘获的小叶并完全穿过其中。
轴100的远端还包括将要配置在患者心脏中的人工腱索或缝线18。缝线18通常是由例如Gore-Tex等公司制造的4-0或5-0缝线。通过操纵抓持机构和针机构180来设置缝线18，如下更详细所述。
轴100的尺寸和形状适合插入患者胸腔，穿过左心室壁，与心肌形成不透水密封。它具有圆形或椭圆形截面，可容纳器械的手柄端与心脏内末端之间的控制链接以及光纤观察系统，如下更详细所述。
如图8A-8F所示，将器械10远端优选实施方式的缝线配置系统设置在待修复的瓣膜小叶16周围，如图8A所示。缝线18中间折叠以形成位于尖端160中的环19。缝线18的两端被设置在杆162下方的轴100中形成的缝线管腔165内。如图8B所示，通过闭合尖端160抓持瓣膜小叶16，延伸针180以刺穿小叶16并延伸进入尖端160。针180一侧上形成的凹口166钩住缝线环19。然后，针180回缩穿过小叶16以将缝线环19牵拉通过穿刺开口，如图8C所示。然后，释放小叶16，器械10从心脏退出，如图8D所示，用器械10牵拉缝线18的两端和中点。如图8E所示，器械10释放缝线18，外科医生将缝线两端21穿过其中点处的环19。然后，牵拉两端21，环19沿缝线18滑入心脏腔室14，在心脏腔室中形成围绕瓣膜小叶边缘的Larks(拉克司)头结，如图8F所示。
可以上述方式植入多条缝线18直到获得令人满意的结果。配置好缝线18之后，通过预先定位的荷包缝线或通过任何类型的适当止血装置或技术来修复心壁切口。检查止血，设置并固定合适的胸腔引流管，并闭合所有切口。
如图9A-9D所示，器械10远端处的缝线配置系统的第二个实施方式是设置在待修复瓣膜小叶16的周围，如图9A所示。在该实施方式中，缝线18是一闭合环，环的一端位于尖端160内，另一端位于管腔164中且包裹围绕针180。针180延伸穿过被抓持的瓣膜小叶16进入器械尖端160，在尖端160中环状缝线18的一端钩住在针的一侧上形成的凹口166，如图9B所示。然后，针180回缩以使环状缝线18通过小叶16中的穿刺开口。然后，通过使尖端160滑入其开放位置而释放小叶，如图9C所示。然后，器械10退出，如图9D所示，使得环状缝线18的未钩住端沿针的长度向小叶16滑动，在小叶16中形成围绕小叶边缘的Larks头结。
然后，器械10从心脏腔室14退出，将缝线18的钩住端牵拉穿过心壁。缝线18固定于心尖的外部。
如图10A-10D所示，器械10远端处的缝线配置系统的第三个实施方式是被设置在待修复瓣膜小叶16的周围，如图10A所示。缝线18的中点17环绕管腔164，其松弛的两端20卷绕在尖端160中。闭合尖端160以俘获瓣膜小叶16之后，针180延伸穿过被抓持的瓣膜小叶160进入器械尖端160。缝线18的游离两端20位于尖端160内以形成环19，在针的一侧上形成的凹口166延伸穿过环19并“钩住”缝线18的游离两端，如图10B所示。然后，针180回缩入管腔164，将缝线18的钩住端牵拉穿过小叶16中的穿刺开口。然后，通过使尖端160滑入其开放位置而释放小叶，如图10C所示。然后，器械10从心脏退出，如图10D所示，将游离两端20牵拉穿过小叶16，缝线18的中点17形成围绕小叶边缘的Larks头结。
然后，器械10从心脏腔室14退出，将缝线18的游离端20牵拉穿过心壁。缝线18的游离端20固定于心尖的外部。
其它缝线配置系统也是可能的，例如，针可穿过小叶，与附连于器械尖端160中环状缝线18一端的褡扣配合装置连接。然后，针退出，将装置和环状缝线向后牵拉穿过小叶中的穿刺开口，如上所述。
如图7所示，为促进手术期间的观察，四个光纤信道170沿器械轴100的长度延伸并在其远端终止。每个信道170包含至少一根照明光纤，其胸腔外末端连接于白光源(图中未示出)。每个信道170还包含至少一根感应光纤，将来自远端的反射光传递回连接于胸腔外末端的可视监视器(图中未示出)。在优选的实施方式中，每个信道170包含两根照明光纤和两根感应光纤。
四个光纤信道170围绕针腔164设置，使得在适当抓持瓣膜小叶16时，瓣膜小叶组织16靠着所有光纤170的远端。结果，光从组织反射回到感应光纤，在可视监视器上显示四个白色圆环。当小叶16不恰当地按压在信道170的远端时，光不会从小叶16反射，可视监视器显示从血液反射的红色。如果没有俘获瓣膜组织，监视器显示四个红点，而在俘获瓣膜组织时，对应于与组织接触的光纤信道170的点变为白色。如果监视器显示所有四个点都是白色的，则表示瓣膜组织俘获是最佳的。如果只有上面两个点变为白色，下面的点仍然是红色，则表示瓣膜小叶16“咬合”太浅而不能适当附连缝线18。
除了确保瓣膜小叶被适当俘获的光纤可视化系统之外，也可采用其它实时可视化系统以便将器械10引导至瓣膜小叶16。优选地，可使用经食道或血管内彩色多普勒超声心动图显象系统来实现上述目的。如上所述，也可采用该成像系统，根据经食道或血管内彩色多普勒超声心动图显象观察反流减少或消失来实时确定新植入的人工腱索的长度。

Claims (17)

1.一种修复心瓣膜的方法，所述方法包括以下步骤：
a)将器械穿过患者胸腔壁进入胸腔；
b)将器械远端穿过心壁进入心脏腔室；
c)用器械远端上的可移动装置抓持心脏瓣膜小叶；
d)用位于器械远端的针刺穿小叶并将缝线牵拉通过穿刺孔以将缝线连接于该小叶；
e)将所述缝线锚定于心脏另一结构；
f)将器械从心脏腔室中退出；和
g)将器械从胸腔中取出。
2.如权利要求1所述的方法，其特征在于，步骤e)包括用器械从步骤F)中所述的心脏腔室拉出缝线并将缝线锚定于心壁外表面。
3.如权利要求2所述的方法，其特征在于，通过采用医疗成像系统观察心瓣膜手术，在锚定之前调节缝线的张力。
4.如权利要求1所述的方法，其特征在于，所述方法包括将荷包缝线设置在围绕器械插入位置周围的心壁中。
5.如权利要求1所述的方法，其特征在于，在步骤b)中所述器械的远端穿过心尖插入。
6.如权利要求5所述的方法，其特征在于，步骤e)包括用器械从步骤f)所述的心脏腔室中拉出缝线和将所述缝线锚定于心尖附近的心壁外表面。
7.一种修复心瓣膜的器械，所述器械包括：
轴，用于插入穿过胸腔壁并进入心脏腔室；
安装在所述轴的远端的可移动元件，可从所述轴的胸腔外末端操纵该元件以抵靠所述轴的末端俘获和保持瓣膜小叶；
设置在器械远端的缝线；和
安装在所述轴远端的针机构，可从所述轴的胸腔外末端操纵该针机构以刺穿被俘获的瓣膜小叶并通过穿刺孔将缝线拉回。
8.如权利要求7所述的器械，其特征在于，所述器械包括：
照明光纤，该照明光纤延伸穿过轴并终止于所述轴的远端；
感应光纤，该感应光纤延伸穿过轴并终止于所述轴的远端；
其中，所述光纤远端被定位成使得在俘获瓣膜小叶时光能够传递至瓣膜小叶并可通过感应光纤反射回去。
9.如权利要求8所述的器械，其特征在于，存在多根照明和感应光纤，这些光纤的远端围绕针机构设置。
10.如权利要求7所述的器械，其特征在于，所述可移动元件是可滑动地安装在所述轴的远端的尖端，所述尖端可从开放位置滑动至闭合位置，在开放位置处，在尖端和所述轴的远端之间形成空隙，在闭合位置处，所述空隙显著降低以将瓣膜小叶抓持于该尖端和轴的远端之间。
11.如权利要求10所述的器械，其特征在于，可操纵所述针机构以使其从所述轴的远端向外延伸穿过被俘获的瓣膜小叶并进入尖端。
12.如权利要求11所述的器械，其特征在于，所述缝线被设置在尖端中，所述针机构包括在延伸入所述尖端时附连于所述缝线的装置。
13.如权利要求12所述的器械，其特征在于，所述用于附连的装置是沿刺穿瓣膜小叶的针的一侧形成的凹口，所述凹口被定位成当所述针机构延伸入尖端时可钩住缝线。
14.如权利要求11所述的器械，其特征在于，所述缝线被设置在轴中，在其延伸入尖端的中点处形成环。
15.如权利要求14所述的器械，其特征在于，所述用于附连的装置是沿刺穿瓣膜小叶的针的一侧形成的凹口，所述凹口被定位成当所述针机构延伸入尖端时可钩住缝线中形成的环。
16.如权利要求11所述的方法，其特征在于，所述缝线是环，所述针机构包括沿刺穿瓣膜小叶的针的一侧形成的凹口，所述凹口被定位成当所述针机构延伸入尖端时可钩住被设置在其中的缝线环的一端。
17.如权利要求16所述的器械，其特征在于，所述缝线环的另一端在接近瓣膜小叶的点处包裹围绕所述针机构。
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US20200121314A1 (en) 2020-04-23
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US11534156B2 (en) 2022-12-27
US20140039324A1 (en) 2014-02-06
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EP1845861A2 (en) 2007-10-24
HK1137130A1 (en) 2010-07-23
ATE513516T1 (de) 2011-07-15
AU2006206591A1 (en) 2006-07-27
CA2595459A1 (en) 2006-07-27
CA2595459C (en) 2013-11-26
US8968338B2 (en) 2015-03-03
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US20100174297A1 (en) 2010-07-08
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US8465500B2 (en) 2013-06-18
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US20170290582A1 (en) 2017-10-12

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