CN100342829C - 改善二尖瓣功能的方法和装置 - Google Patents
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Abstract
一种减小二尖瓣回流的方法和装置。该装置插入病人的二尖瓣后尖附近的冠状窦中,该装置适合于拉直二尖瓣后尖附近的冠状窦的至少一部分的天然弯曲形状,从而向前移动后环,并由此改善瓣尖接合和减小二尖瓣回流。
Description
未决在先专利申请的引用
本专利申请要求享有对下列文献的优先权:
(1)由William E.Cohn等人于02/05/01提出申请的顺序号为60/266,766的未决在先美国临时专利申请《二尖瓣手术的经血管途径》(专利律师文件号No.VIA-16临时);
(2)由William E.Cohn等人于03/05/01提出申请的顺序号为60/273,893的未决在先美国临时专利申请书《用于二尖瓣手术的经血管方法和器件》(专利律师文件号No.VIA-17临时);
(3)由William E.Cohn等人于03/23/01提出申请的顺序号No.60/278,153的未决在先美国临时专利申请《改善二尖瓣功能的方法和装置》(专利律师文件号No.VIA-18临时);
(4)由Daniel C.Taylor等人于03/29/01提出申请的顺序号为60/279,974的未决在先美国临时专利申请《改善二尖瓣功能的方法和装置)》(专利律师文件号No.VIA-19临时);
(5)由William E.Cohn等人于03/30/01提出申请的顺序号No.60/280,038的未决在先美国临时专利申请《用于暂时改善二尖瓣功能的方法和装置》(专利律师文件号VIA-20临时);
(6)由Daniel C.Taylor等人于03/29/01提出申请的顺序号No.60/279,973的未决在先美国临时专利申请《改善二尖瓣功能的方法和器件》(专利律师文件号No.VIA-21临时);
(7)由William E.Cohn等人于04/13/01提出申请的顺序号No.60/283,820的未决在先美国临时专利申请《暂时改善二尖瓣功能的方法和装置》(专利律师文件号No.VIA-22临时);
(8)由Daniel C.Taylor等人于08/14/01提出申请的顺序号No.60/312,217的未决在先美国临时专利申请《用于暂时改善二尖瓣功能的方法和装置》(专利律师文件号No.VIA-23临时);
(9)由William E.Cohn等人于10/26/01提出申请的顺序号No.60/339,481的未决在先美国临时专利申请《二尖瓣手术的经血管途径》(专利律师文件号No.VIA-30临时);以及
(10)由Daniel C.Taylor等人于01/14/02提出申请的顺序号No.60/348,424的未决在先美国临时专利申请《(改善二尖瓣功能的方法和装置》(专利律师文件号No.VIA-31临时)。
上述10个专利申请书均参考合并于此。
发明领域
本发明总的涉及外科手术的方法和装置,尤其涉及改善二尖瓣功能用的外科手术方法和装置。
发明背景
二尖瓣修复是矫正所有病因的二尖瓣回流的选择性的手术。采用当前的外科技术,能够修复70%~95%的回流的二尖瓣。二尖瓣修复相对于二尖瓣置换的优点在文献中有充分报道。这些优点包括更好地保存心脏功能和减少与抗凝血有关的出血、血栓栓塞、心内膜炎的风险。
在当前的实践中,二尖瓣外科手术需要一条侵害极大的通道,该通道包括胸壁切口、心肺分流、心搏和肺的停止以及心脏本身上的切口,以获得通往二尖瓣的入口。这样一种手术伴随着高的发病率和死亡率。由于这种手术伴随的风险,许多严重病人不能享受到二尖瓣回流手术矫正带来的潜在好处。此外,二尖瓣回流中等症状的病人不能进行早期手术而只在心脏机能障碍发展后才进行手术矫正。
二尖瓣回流在心力衰竭病人中常常发生,是这些病人的严重发病率和死亡率的一个重要来源。心力衰竭病人的二尖瓣回流是由于左心室、乳头肌和二尖瓣环的几何构型的变化而引起的。这些几何变化造成二尖瓣瓣尖在收缩期的不完全接合。在这些情况下,二尖瓣回流通过二尖瓣环的打褶来矫正,或者是单独采用缝线,或者是缝线与支撑环相结合,以便减小扩张环的周长并恢复二尖瓣环的初始几何形状。
尤其是,当前二尖瓣修复的外术手术实践通常要求通过外科手术打开左心房而后在环的内表面上固定缝线或更普遍地用缝线与支撑环结合来减小二尖瓣环的半径;这种构造用于以荷包袋方式将环捆紧到更小的半径,由此通过改善瓣尖接合来减小二尖瓣回流。
这种二尖瓣修复方法通常称为“环整复术(annuloplasty)”,该手术能有效地减小心力衰竭病人的二尖瓣回流。这转过来又能减小心力衰竭的症状、提高生活质量和延长寿命。但不幸的是,二尖瓣外科手术的侵害性质及伴随的风险使大多数心力衰竭病人很少进行手术。因此,一种增大心力衰竭病人的瓣尖接合而由此减小二尖瓣回流的侵害较小的方法将使这一疗法可对更加多得多的病人有用。
二尖瓣回流也出现在约20%的患急性心肌梗塞形成的病人中。此外,二尖瓣回流是约10%的在急性心肌梗塞形成的背景中出现严重的血液动力不稳定性的病人的心原性休克的主要原因。具有二尖瓣回流和心原性休克的病人存在约50%的医院死亡率。对这些病人消除二尖瓣回流有显著的好处。但不幸的是,具有并发急性心肌梗塞形成的急性二尖瓣回流的病人是特高风险的外科手术候选人,因此不是常规的环整复术手术的良好后选人。因而,一种在这些危重病人中实现暂时减小或消除二尖瓣回流的侵害极小的方法将给病人提供从心肌梗塞形成或其它急性威胁生命的事件中恢复的时间,并使他们成为药物、干预或外科手术疗法的更好的候选人。
发明概要
因此,本发明的一个目的是提供一种用于减小二尖瓣回流的改进的方法和装置。
本发明的另一目的是提供一种用于减小二尖瓣回流的侵害极小的方法和装置。
本发明的另一目的是提供一种用于减小二尖瓣回流的能够永久地部署(例如对患心力衰竭的病人)或暂时地部署(例如对患具有急性心肌梗塞形成的二尖瓣回流的病人)的装置和方法。
本发明满足这些目的和其它目的,本发明包括一种用于减小二尖瓣回流的改进的方法和装置。
在本发明的一种形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一种装置插入病人的二尖瓣后尖附近的冠状窦中,该装置适合于拉直二尖瓣附近的冠状窦的至少一部分的天然弯曲形状,从而向前移动后环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一种装置插入病人的二尖瓣后尖附近的冠状窦中,该装置适合于向前移动二尖瓣后尖附近的冠状窦的至少一部分,从而向前移动后环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一种装置插入病人的二尖瓣后尖附近的冠状窦中,该装置适合于减小二尖瓣后尖附近的冠状窦的至少一部分的天然弯曲程度,从而向前移动后环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一种装置插入病人的二尖瓣后尖附近的冠状窦中,该装置适合于增大二尖瓣后尖附近的冠状窦的至少一部分的天然弯曲半径,从而向前移动后环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一种装置插入病人的二尖瓣后尖附近的冠状窦中,该装置有一远端、一近端和一中间部分,该装置做成这样的形状,使得当该装置安置在二尖瓣后尖附近的冠状窦中时,该远端和近端将对冠状窦的壁施加一向后的力,而该中间部分将对冠状窦的壁施加一向前的力,从而向前移动后环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一个基本上直的细长主体插入病人的二尖瓣后尖附近的冠状窦中,该基本上直的细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状做成使得当该基本上直的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分采取一种邻近于二尖瓣后尖的基本上直的构型,从而增大二尖瓣环的曲率半径,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一个基本上刚性的细长主体插入病人的二尖瓣后尖附近的冠状窦中,该基本上刚性的细长主体的形状相对于二尖瓣后尖附近的冠状窦的天然弯曲形状做成使得当该基本上刚性的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分采取一种邻近于二尖瓣后尖的不同构型,从而向前移动后环,并由此改善瓣尖接合。
在本发明的另一种形式中,提供一种用于减小二尖瓣回流的方法,包括:
将一个直的基本上刚性的细长主体插入病人的二尖瓣后尖附近的冠状窦中,该直的基本上刚性的细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状做成使得当该直的基本上刚性的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分采取一种邻近于二尖瓣后尖的基本上直的构型,从而增大二尖瓣环的曲率半径,并由此改善瓣尖结合。
在本发明的另一形式中,提供一种减小二尖瓣回流用的装置,包括:
一个有一远端、一近端和一中间部分的主体,该主体的形状做成使得当该主体安置在二尖瓣后尖附近的冠状窦中时,该远端和近端将对冠状窦的壁施加一向后的力,而该中间部分将对冠状窦的壁施加一向前的力,从而向前移动二尖瓣的后环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种减小二尖瓣回流用的装置,包括:
一个适合于插入病人的二尖瓣后尖附近的冠状窦中的基本上直的细长主体,该基本上直的细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状做成使得当该基本上直的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分采取一种邻近于二尖瓣后尖的基本上直的构型,从而增大二尖瓣环的曲率半径,向前移动二尖瓣环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种减小二尖瓣回流用的装置,包括:
一个适合于插入病人的二尖瓣后尖附近的冠状窦中的基本上刚性的细长主体,该直的基本上刚性的细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状做成使得当该基本上刚性的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分采取一种邻近于二尖瓣后尖的不同构型,从而向前移动后环,并由此改善瓣尖接合。
在本发明的另一形式中,提供一种减小二尖瓣回流用的装置,包括:
一个适合于插入病人的二尖瓣后尖附近的冠状窦中的直的基本上刚性的细长主体,该直的基本上刚性的细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状做成使得当该直的基本上刚性的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分采取一种邻近于二尖瓣后尖的基本上直的构型,从而增大二尖瓣环的曲率半径,向前移动二尖瓣环,并由此改善瓣尖接合。
重要的是,本发明可以以侵害极小的方式实施,或者是永久地,或者是暂时地,从而减小二尖瓣回流。
附图简述
本发明的上述和其它目的和特点可以通过下述与附图结合的本发明优选实施例的描述而更充分地公开或阐明,附图中相同的标号标示相同的部件,其中:
图1是人体血管系统各部分的示意图;
图2是人体心脏各部分的示意图;
图3是按照本发明制成的优选系统的示意图;
图4~图7是一系列例示利用图3的系统来减小二尖瓣回流的视图,
图8表示输送导管的一种替代形式;
图9表示可弯曲的推杆的一种替代形式,
图9A表示本发明的另一替代形式;
图10和图11表示该直的基本上刚性的细长主体的替代构造;
图12表示按照本发明制成的一种替代系统;以及
图13表示图12所示系统的使用。
优选实施例详述
冠状窦是人体心脏中最大的静脉。在其经过房室沟中的一大部分中,冠状窦通常延伸在邻近心脏左心房的约5~10cm处。重要的是,对于其部分长度(如通常约7~9cm),冠状窦的延伸基本上邻近于二尖瓣环的后周边。本发明利用这一事实。更具体地说,通过在冠状窦中邻近二尖瓣的后尖部署新颖装置,可在二尖瓣后尖附近改变冠状窦的天然曲率,由此向前移动该后环,从而改进瓣尖接合,因此减少了二尖瓣回流。
在本发明的一个优选实施例中,该新颖装置包括一个直的基本上刚性的细长主体,其长度做成使得当其在二尖瓣后尖附近安置在冠状窦中时,该直的基本上刚性的细长主体将使得冠状窦的至少一部分采取一个邻近二尖瓣后尖的基本上直的构型,从而向前移动该后环,并由此改善瓣尖接合。
在本发明的一个优选实施例中,进入冠状窦是用经皮方式达到的,例如,该直的基本上刚性的细长主体通过颈静脉通过左锁骨下静脉、向下通过上腔静脉、通过右心房,然后通入冠状窦中,部署在那里,从而引入病人的血管系统。或者是,该直的基本上刚性的细长主体可以通过心脏中的一个小切口或通过进入病人血管系统的一些其它切口而引入冠状窦。
在本发明的一个优选实施例中,该直的、基本上刚性的细长主体通过下列方法引导到位置中:(i)通过一根预先安置的导管使其通过;(ii)在一根预先安置的导线上使其通过;(iii)无导线地(如在一个可以操纵的输送工具的端部上)使其通到外科手术部位。
一旦部署好,该新颖装置可以永久地留在位置中(例如在病人患有伴随心力衰竭的二尖瓣回流的情况下),或者该新颖装置可以暂时地留在位置中(例如在病人患有伴随急性心肌梗塞形成二尖瓣回流的情况下)。
手术的造影可以通过荧光镜透视法、超声波心动图法、血管内超声法、毛细血管显微镜法、实时磁共振成象法等来获得。手术的功效可以通过超声波心动图法来确定,虽然其它成象方式也可能是适用的。
现在参照图1,图中示出病人的心血管系统3的一些部分。更具体地说,心血管系统3通常包括心脏6、上腔静脉9、右锁骨下静脉12、左锁骨下静脉15、颈静脉18和下腔静脉21。上腔静脉9和下腔静脉21与右心房24连通。冠状口27引导到冠状窦30。在冠状窦30的远端31(图2)处,血管构造转变为垂直下降的前心室间静脉(“AIV”)32(见图1)。对于本发明的目的,通常可以方便地认为术语“冠状窦”指延伸在冠状口27和AIV 32之间的血管构造。
如图2中所见,在冠状口27和AIV 32之间,冠状窦30的延伸通常基本上邻近于二尖瓣36的环33的后周边。二尖瓣36包括后尖39和前尖42。在回流的二尖瓣的情况下,后尖39和前尖42在收缩时通常不能合适地接合,由此留下一个将允许回流的居中间隙45。
下面参看图3,图中示出一个包括本发明一优选实施例的系统100。更具体地说,系统100总的包括一根导线103、一根输送导管106和一根推杆109。
导线103包括一个具有远端115和近端118的可弯曲的主体112。导线103的远端115最好包括一个弹性尖端121,以便使导线103的远端能够无外伤地通过血管构造,也即导线通过病人的血管系统。
输送导管106包括一个具有远端127和近端130的可弯曲的主体124,近端130上最好有一附接的可调整的瓣133。中心腔136从远端127延伸到近端130。在某些情况下,最好提供一个固定机构,以便将输送导管的远端固定在血管构造内。作为例子但并无限制,可以在刚巧接近远端127的可弯曲的主体124的外面周围安置一个气囊139,在气囊139和充气装置145之间延伸一个充气腔142。
推杆109包括一个具有远端151和近端154的可弯曲的主体148。在可弯曲的主体148的接近远端151处形成一个可以有各种不同长度的直的基本上刚性的细长的主体157。在该细长的主体157和近端154之间可以安置一个可以移动的近侧的加劲杆或把手160。
系统100可以使用如下以减小二尖瓣回流。
首先,将导线103的远端115向下通过病人的颈静脉18(或左锁骨下静脉15)、上腔静脉9,通过右心房24,然后进入冠状窦30。参见图4,可以理解,由于导线的可弯曲的特性,当导线103向下通过冠状窦30时,该导线倾向于采取冠状窦的天然弯曲形状。导线的无外伤的弹性尖端121将有助于保证当导线103被操纵进入位置时对血管构造损伤极小。
其次,将输送导管106的远端127安置在导线103的近端118上并向下通过导线,直到输送导管的远端安置在冠状窦30内。参见图5。再一次可以理解,由于输送导管的可弯曲的特性,当可弯曲的输送导管106向下通过冠状窦时,该输送导管将倾向于采取冠状窦的天然弯曲形状。
一旦输送导管106已安置在冠状窦内,就移去导线103。参见图6。在导线103移去之前或之后,气囊139可以充气,从而使输送导管106的远端127固定在冠状窦30内的位置上。
其次,使推杆109向下通过输送导管106的中心腔136。当推杆的直的基本上刚性的细长主体157向下通过输送导管106的中心腔136时,该主体157将迫使输送导管在主体157当前停留的点采取一个直的构型。当推杆109向下推动输送导管106时,气囊139将使输送导管的远端保持在冠状窦30内的位置上。
使推杆109向下推动输送导管106,需要时利用可以移动的近侧的加劲杆160,直到直的基本上刚性的细长主体157安置在二尖瓣36的后环的附近。参见图7。当这种情况发生时,输送导管106内的直的基本上刚性的细长主体157的存在将使至少一部分冠状窦30在该点上采取一个基本上直的构型,使得二尖瓣36的后环受力向前。这将使二尖瓣的后尖39也向前移动,从而改善二尖瓣瓣尖的接合,并因此减小(或完全消除)二尖瓣回流。在这方面应当理解,后环可能向前移动,从而达到或企图达到解剖学上可能的程度的瓣尖对瓣尖的啮合或瓣尖对环的啮合(例如在该处由于左心室畸变而束缚住一个瓣尖)。这两种类型的啮合或目标啮合都预定用术语“改善的瓣尖接合”和/或“增大的瓣尖接合”之类来包括。利用标准的显示方法(如超声波心动图法或荧光镜透视法)来调整该直的基本上刚性的细长主体157的精确位置,从而减小(或完全消除)二尖瓣36中的回流。
在这方面应当理解,该直的基本上刚性的细长主体157的尺寸最好稍许小于冠状口27和AIV 32之间的长度。但是,在某些情况下,该直的基本上刚性的细长主体157的尺寸最好做成将伸出冠状窦而进入右心房。
此外,也应当理解,该系统在布署期间对使用人提供一定程度的触觉反馈。更具体地说,当直的基本上刚性的细长主体157被推出右心房24而进入冠状窦30时,通常会遇到显著的阻力;然后当主体157移动通过冠状窦时阻力通常将减小;然后当主体157的远端尖端到达冠状窦的远端31时阻力通常将再一次显著增大。因此,当直的基本上刚性的细长主体157位于冠状口27和AIV 32之间的冠状窦内时有一种触觉的“有利点”,这个触觉的“有利点”能够有助于使用人将直的基本上刚性的细长主体157安置在冠状窦30中。
在这个点处该直的基本上刚性的细长主体157被锁定在位置中,例如通过关闭可调整的瓣133,而气囊139可以放气。
系统100留在该位置中,直到其不再需要。在某些情况下这可能意味着系统100留在该位置中达几小时、几天或几星期;在另一些情况下系统100可能基本上是永久的。如果和当系统100被移去时,推杆109从输送导管106中被移去,然后从病人身上移去输送导管106。
因此可以看出,使用本发明,该直的基本上刚性的细长主体157基本上被压配合到冠状窦的邻近二尖瓣后尖的通常弯曲的部分中。通过合适地选定该直的基本上刚性的细长主体157相对于病人解剖生理的天然弯曲程度的长度,并通过将该直的基本上刚性的细长主体157合适地安置在病人的冠状窦中,该直的基本上刚性的细长主体将使至少一部分冠状窦采取邻近于二尖瓣后尖的基本上直的构型。这一作用将转而向前驱动二尖瓣的后环,从而改善瓣尖接合并由此减小二尖瓣回流。因此,通过将该直的基本上刚性的细长主体157插入邻近于二尖瓣后尖的冠状窦中,能够有效地操纵二尖瓣的环,从而使该环有一个增大的曲率半径。
也已经发现,通过将该直的基本上刚性的细长主体插入邻近于二尖瓣后尖的冠状窦中,也可使左心室重新造型,从而有助于减轻充血性心力衰竭。
值得注意的是,使用本发明,该直的基本上刚性的细长主体157的远端和近端在冠状窦30壁上施加一向后方向的力(如图7中箭头P所示),而该细长主体157的中间部分在冠状窦30的壁上施加一向前方向的力(如图7中箭头A所示)。
在一些情况下,输送导管106的近端130可以用标准的治疗方法如胶粘带、缝合线、皮肤钉等固定在病人外皮肤上。在另一些情况下,输送导管106的近端130可以包括一个缝合套,通过缝合将输送导管固定在病人的组织上。例如参见图8,图中示出一个附接在输送导管106的近端130上的缝合套166。如果需要,可以在可调整的瓣133的近侧设置一个元件169,由此可以使可弯曲的推杆109固定在输送导管106上。作为例子,元件169可以包括一个可翻边的元件而将可弯曲的推杆109固定在输送导管106上,后者又转而固定在病人身上。如果需要,可以将该装置的近端埋置在病人的皮肤下面,例如在永久性植入物的情况下。
如上所述,在将推杆109推入输送导管之前将输送导管106的远端固定在冠状窦内的位置中可能是有帮助的。当推杆在右心房内旋转并进入冠状窦时,这样一种安排将使输送导管保持在位置中。在没有这样一种固定的情况下,推杆可能驱动输送导管下到下腔静脉21中。通过将输送导管106的远端固定在冠状窦30的壁上,当该直的基本上刚性的细长主体157遭遇初始阻力而转入冠状窦时,输送导管能够稳定地对抗下到下腔静脉21中的转向。
气囊139是完成此种固定的一种方法。但是,也可以利用其它种类的固定机构来将输送导管106的远端127固定在冠状窦30内的位置中,如弹簧夹、肋板等。
另一种方法,参见图9,推杆109的远端151本身可以设置一个远端固定器,如图9中所示的远端固定器172。
也可以不将输送导管106的远端或可弯曲的推杆109固定在冠状窦的壁上而防止输送导管106转向下到下腔静脉21中。更具体地说,参见图9A,图中示出一根用比输送导管106更刚性的材料制成的支撑导管173。支撑导管173这样构造,使得其远端174能够安置在冠状口27中,然后当推杆109向下通过输送导管106时远端174的侧壁174A能够支撑邻近于下腔静脉21的输送导管106,由此防止输送导管106转向下到下腔静脉106中。图9A也表示了在颈静脉18入口处的引入导管174B。
如上所述,当推杆109前进到邻近于二尖瓣后环的区域时,该直的基本上刚性的细长主体157将使冠状窦的天然构型发生畸变,使其采取一个基本上直的构型。虽然这个作用产生所要的瓣的改型,但它也能在冠状窦的壁上产生一个显著的应力,特别是在该直的基本上刚性的细长主体157的远端和近端上,这些部位应力将会集中。为此,该直的基本上刚性的细长主体157的构造可以稍许改变,以便更好地分布该应力。更具体地说,参见图10,该直的基本上刚性的细长主体157的远端和近端可以包括相当地可以弯曲的部分175,以帮助施加在冠状窦壁上的应力更好地分布。此外和/或或者是,可以伸长外加在该直的基本上刚性的细长主体157的远端和近端上的任何锥形(如图11中在178处所示),从而更好地分布加在冠状窦壁上的应力。
参见图12,图中示出一个组成本发明另一优选实施例的系统181。更具体地说,系统181总的包括导线103、一个直的基本上刚性的细长主体184和一根推动套管187。
导线103如前所述。
可以具有各种不同长度的直的基本上刚性的主体184包括一个远端188和一个近端190。在远端188和近端190之间延伸一个中心腔193。中心腔193容放导线103。
推动套管187包括一个远端194和一个近端196。在远端194和近端196之间延伸一个中心腔199。中心腔199容放导线103。
系统181可以使用如下以减小二尖瓣回流。
首先,将导线103的远端115向下通过病人的颈静脉18(或左锁骨下静脉15)、上腔静脉9,通过右心房24,进入冠状窦30。可以理解,当可弯曲的导线向下通过冠状窦30时,由于导线的可弯曲的特性,该导线将倾向于采取冠状窦的天然弯曲形状。当导线进入位置时,导线的无外伤的弹性尖端121将有助于尽可能减小对血管构造的损伤。
其次,将直的基本上刚性的细长主体184的远端188安置在导线103的近端118上并沿导线向下通过一个短距离。然后将推动套管的远端194安置在导线103的近端118上,而后沿导线向下推进推动套管187。当推动套管187沿导线向下推进时,其远端194推动在其前面的该直的基本上刚性的细长主体184。参见图13。
当直的基本上刚性的细长主体184向下通过冠状窦时,该细长主体184将迫使冠状窦在细长主体184当前停留的点处采取一种直的构型。如果需要,沿导线向下推动该导管187,直到该直的基本上刚性的细长主体184安置在二尖瓣后环的附近。当这一点实现时,该直的基本上刚性的细长主体184在冠状窦中的存在将使冠状窦在该点处采取一个基本上直的构型,从而迫使二尖瓣后环向前。这将使二尖瓣后尖也向前移动,从而改善瓣尖接合并由此减小(或完全消除)二尖瓣回流。利用标准的显示方法(如超声波心动图法或荧光镜透视法),可以调整该直的基本上刚性的细长主体的精确位置,从而减小(或完全消除)二尖瓣中的回流。
如果需要,该推动套管187可以设置一个可脱开地附接的界面(如抓紧器),使其可以可脱开地抓紧该直的基本上刚性的细长主体184的近端190。这样一个特点将使该直的基本上刚性的细长主体可以在冠状窦中被拉回,不管是用于安置还是退回的目的。
另一种方法是,细长主体184或157可以沿其长度有各种非直线的形状。例如,该细长主体沿其长度的一部分或全部可以是波形的、螺旋形的或曲线形的。作为例子,细长主体157和/或184可以有一个与冠状窦的天然弯曲形状相反的弯曲构型,也即使其向前环弯曲。或者该细长主体可以沿其长度有一复合的形状,例如可以有一“W”形状,“W”形的中心指向前环。这些或其它替换形状的任何一种都可以影响后环的向前移动而导致减小二尖瓣回流。
在其它替换的实施例中,该细长主体可以沿其长度的至少一部分是可弯曲的。局部可弯曲性和局部刚性可以允许拉直冠状窦的选定位置和二尖瓣后环的相应位置。这能够使二尖瓣环的一些部位向前移动,从而导致局部改善瓣尖接合。此外,该细长主体可以做成用一根丝将两个端部连接在一起;通过相对于解剖生理形状固定两个端部和拉动所述丝,能够拉直冠状窦的天然弯曲的壁,从而向前移动二尖瓣后环,并由此减小二尖瓣回流。
可以理解,本发明绝不限于本文公开和/或附图中显示的特定构造,而还包括权利要求书范围内的任何变化或等同内容。
Claims (13)
1.减小二尖瓣回流用的装置,包括:
一个有一远端、一近端和一中间部分的主体,该主体的形状这样确定,使得当该主体安置在二尖瓣后尖附近的冠状窦中时,该远端和近端将对冠状窦的壁施加一向后的力,而该中间部分将对冠状窦的壁施加一向前的力,从而向前移动二尖瓣的后环,并由此改善瓣尖接合。
2.减小二尖瓣回流用的装置,包括:
一个适合于插入病人的二尖瓣后尖附近的冠状窦中的基本上直的细长主体,该基本上直的细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状这样确定,使得当该基本上直的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分呈现一种邻近于二尖瓣后尖的基本上直的构型,从而增大二尖瓣环的曲率半径,向前移动二尖瓣环,并由此改善瓣尖接合。
3.减少二尖瓣回流用的装置,包括:
一个适合于插入病人的二尖瓣后尖附近的冠状窦中的基本上直的和刚性的细长主体,该细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状这样确定使得当该细长主体安置在冠状窦中时,该细长主体保持基本上直的并使冠状窦的至少一部分呈现一种邻近于二尖瓣后尖的较直的构型,从而向前移动后环,并由此改善瓣尖接合。
4.减小二尖瓣回流用的装置,包括:
一个适合于插入病人的二尖瓣后尖附近的冠状窦中的直的基本上刚性的细长主体,该直的基本上刚性的细长主体的长度相对于二尖瓣后尖附近的冠状窦的天然弯曲形状这样确定使得当该直的基本上刚性的细长主体安置在冠状窦中时,该细长主体将使冠状窦的至少一部分呈现一种邻近于二尖瓣后尖的基本上直的构型,从而增大二尖瓣环的曲率半径,向前移动二尖瓣环,并由此改善瓣尖接合。
5.按照权利要求4所述的装置,其特征在于还包括一根适合于安置在病人的冠状窦中的输送导管,所述可弯曲的输送导管是用可弯曲的材料制成的,使得该输送导管将基本上呈现冠状窦的构型,所述输送导管适合于在其中容纳所述直的基本上刚性的细长主体。
6.按照权利要求5所述的装置,其特征在于,所述直的基本上刚性的细长主体安装在一根杆上,其中所述杆是用一种可弯曲的材料制成的,使得所述杆将呈现该冠状窦的构型,其中所述杆的尺寸被定得能安装在所述输送导管中。
7.按照权利要求4所述的装置,其特征在于还包括一根用于将所述输送导管安置在冠状窦中的可以移去的导线。
8.按照权利要求4所述的装置,其特征在于还包括一根适合于安置在冠状窦中的导线,所述导线用一种可弯曲的材料制成,使得该导线基本上呈现该冠状窦的构型,并且其中该直的基本上刚性的细长主体插有管套,以便沿所述导线行进。
9.按照权利要求4所述的装置,其特征在于,所述直的基本上刚性的细长主体的远端和近端中的至少一端包括一可弯曲的部分,用于当所述直的基本上刚性的细长主体安置在冠状窦中时释放施加在冠状窦上的应力。
10.按照权利要求4所述的装置,其特征在于,所述直的基本上刚性的细长主体的远端和近端中的至少一端是锥形的,用于当所述直的基本上刚性的细长主体安置在冠状窦中时释放施加在冠状窦上的应力。
11.按照权利要求4所述的装置,其特征在于,所述直的基本上刚性的细长主体的长度不大于位于冠状口和前心室间静脉之间的冠状窦区段的长度。
12.按照权利要求5所述的装置,其特征在于,所述装置还包括一个支撑导管,用于当所述直的基本上刚性的细长主体通过所述输送导管时防止所述输送导管转入下腔静脉。
13.减小二尖瓣回流用的装置,包括:
一个适合于插入病人的二尖瓣后尖附近的冠状窦中的直的和刚性的细长主体,该主体在冠状窦中保持基本上直的,并因此适合于使二尖瓣后尖附近的冠状窦的至少一部分的天然弯曲形状转化,从而向前移动后环,并由此改善瓣尖接合。
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WO2002062408A3 (en) | 2003-03-27 |
WO2002062408A2 (en) | 2002-08-15 |
EP1367962A4 (en) | 2008-10-01 |
JP4184794B2 (ja) | 2008-11-19 |
CN1582136A (zh) | 2005-02-16 |
US20050049679A1 (en) | 2005-03-03 |
AU2002240288B2 (en) | 2006-05-18 |
CA2437387A1 (en) | 2002-08-15 |
EP1367962A2 (en) | 2003-12-10 |
US20020183835A1 (en) | 2002-12-05 |
JP2004533862A (ja) | 2004-11-11 |
US6656221B2 (en) | 2003-12-02 |
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