CN1436056A - 用于定位卵圆窝的方法和设备 - Google Patents

用于定位卵圆窝的方法和设备 Download PDF

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CN1436056A
CN1436056A CN01808118A CN01808118A CN1436056A CN 1436056 A CN1436056 A CN 1436056A CN 01808118 A CN01808118 A CN 01808118A CN 01808118 A CN01808118 A CN 01808118A CN 1436056 A CN1436056 A CN 1436056A
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M·D·莱什
A·K·海尔卡安
E·J·范德布
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Ev3 Peripheral Inc
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Abstract

一种用来辨认和通过一诸如卵圆窝(72)之类的组织结构来进入的导管。该导管(20)包括一根细长的管状体(26)，该管状体(26)具有一个近端(22)、一个末端(24)以及一个设在末端上的可缩回的刺穿结构(42)。一个检测装置(37)与导管一起使用，以能检测到导管的末端放置在卵圆窝上。

Description

用于定位卵圆窝的方法和设备
技术领域
本发明涉及用来从右心房横穿卵圆窝进入左心房的横穿隔膜进入系统。更具体地说，本发明涉及用于定位卵圆窝的方法和设备。
背景技术
典型的人类心脏包括一个右心室、一个右心房、一个左心室以及一个左心房。右心房与上腔静脉和下腔静脉流体相通。三尖瓣膜将右心房从右心室分隔开。在右心房与左心房分隔的内壁上有一个薄壁的凹进部分，亦即卵圆窝。在胎儿的心脏中，卵圆窝是打开的(卵圆孔未闭)，以允许胎儿的血液在左右心房之间流动，这样的流道绕过胎儿的肺，利于胎盘血液的流动。大多数人的这个开口在出生后就关闭了。在约5％的成人中，在左右心房之间的卵圆窝的原来位置上仍保持有一个开口(卵圆孔未闭)。
人们研究出了许多导管穿越腔室进入到各种腔室并穿过心脏瓣膜的诊断和治疗方法。心脏中导管最难进入的腔室是左心房。通过肺动脉进入左心房是不可能的。从左心室进入的途径也很困难，可能会导致心律失常，并可能会难于稳定地定位导管。因此，目前较佳的进入左心房的方法是通过一条横穿隔膜的路径，这是通过将导管插入右心房并接着刺穿心房间隔膜来实现的。卵圆窝处的变薄的壁厚和卵圆窝的位置都使它成为一个有用的用于横穿隔膜进入刺穿的进入点。
除了通常的心脏插管的危险以外，伴随横穿隔膜的插入导管还会产生许多危险。附加的主要危险与没有准确地辨认和定位心房隔膜、尤其是卵圆窝有关。横穿隔膜刺穿之前未正确放置导管的尖端会引起刺穿诸如大动脉和左或右心房的后壁之类的非心房间隔膜组织的危险。由于这个原因，伴随插管还一起使用荧光检查或其它可视技术，以协助相对于隔膜正确定位导管的尖端。
左心房进入的目的可以是诊断或者治疗。一种诊断用途是用于测量左心房内压力。在阻塞二尖瓣(二尖瓣狭窄)的位置，进入左心房能确定左心房和左心室之间的压力差。左心房进入还能允许通过二尖瓣进入到左心室中。这在设置一人造大动脉瓣时是需要的。用人造机械瓣膜替代大动脉瓣膜的出现，以及大动脉瓣膜替换后的老龄人口的增长和老龄人口的日益长寿，就更需要评价这样的人造瓣膜的后期功能性。
因此就要求对左心室压力作诊断性测量，以能对替换后的机械人造大动脉瓣膜进行评价。从大动脉倒退穿过这些机械的人造瓣膜可能是不安全的。因此，用横穿隔膜的刺穿经过顺行的路线进入到左心室是较佳进入方式。一旦导管已经使用横穿隔膜的进入方式进入到在左心房内，就能通过将导管前伸穿过二尖瓣来进入左心室中。
除了评价人造二尖瓣的功能性以外，还存在许多用于左心房压力测量的诊断指征。其它通过顺行的横穿隔膜路径进入左心室的诊断指征包括大动脉狭窄，这时心脏病专家不能将导管倒退入左心室，以及包括一些顺行路径被认为是较适宜的疾病症状，如主动脉瓣下阻塞。
目前，左心房进入的治疗目的主要有两个。第一个是二尖瓣瓣膜成形术，它是减轻二尖瓣阻塞的外科手术方法的一种替代方法。第二个治疗目的是用于在左心房中进行电生理学干涉。导管切除包括通过导管施加能量(一般地为无线电频率)到心脏的各种位置上，以根除影响心脏功能的不恰当电气途径。当这些位置在左心房中时，其中放置无线电频率发生器的导管本身通常地是通过横穿隔膜插管来放置。最近，人们还提出了左心房附属物的治疗方法以减小栓塞中风的危险性。
尽管临床上已接受了许多要进入左心房的方法，但在实际的进入技术中还留有可改进的很大空间。例如，在隔膜诸如卵圆窝上定位治疗的一个适当位置的步骤是十分依靠技术的，并可能会不准确。这增加了手术的时间，并可能会发生针头在不需要和可能未想要的位置上剌穿心脏壁的危险性。因此，人们需要一种快速准确定位并刺穿卵圆窝的设备和方法以实现快速准确的横穿隔膜进入。
发明内容
根据本发明的第一个方面，提供一种定位卵圆窝的方法。该方法包括将一根导管的末端头置于心脏中的步骤和从该导管传送一个信号的步骤。导管接收返回信号，并且导管的尖端移动到一个返回信号指示为卵圆窝的位置上。
在一个实施例中，传送一个信号的步骤包括传送一个超声波信号。或者，信号传送步骤包括传送一个诸如在紫外线—可见光或红外范围内信号的电磁信号。较适宜的是，电磁信号包括多种波长，至少包括红光、绿光及蓝光中的一种。
根据本发明的另一个方面，提供一种横穿隔膜进入系统。该系统包括一个护套、一个扩张器、一个针头以及至少在护套、扩张器及针头中的一个上的一个信号发送面和一个信号接收面，以用来传输信号和接收信号。
在一个实施例中，信号发送面和信号接收面包括同一表面。信号发送面和/或信号接收面可以为一根波导线的末端。或者，信号发送面和信号接收面可以为一个转换器。较适宜的是，该系统还包括一个诸如红光、绿光及蓝光之类的光源，并与信号发送面相通信。一个能检测返回信号的频率和亮度的检测装置与信号接收面相通信。
根据本发明的再一个方面，提供一种用于定位卵圆窝的方法。该方法包括使一导管与左和右心房之间的隔膜表面接触的步骤和沿着隔膜移动该导管的步骤。对表示卵圆窝位置的在隔膜内或超过隔膜时的颜色吸收的变化进行监控。较适宜的是，监控步骤包括检测反射光线。因此，该方法较适宜的是包括通过导管将光线向末端发送至隔膜并通过导管将向近侧反射的光线接收到一个检测装置的步骤。
在参照下面对较佳实施例的详细描述，并与所附图和权利要求一起考虑后，本发明的其它特征和目的对那些熟悉该技术领域的人们来说会变得更为清晰。
附图说明
图1为根据本发明的一个横穿隔膜进入系统的示意侧视图；
图2为沿图1中线2-2所见的剖面图；
图3为图1所示横穿隔膜进入系统的末端的放大的立体图；
图4为心脏一部分的示意性剖面图，所示为本发明的一个横穿隔膜进入导管在右心房中的情况；
图5为与图4一样的剖面图，所示为导向线位于上腔静脉中时的情况；
图6为与图4一样的剖面图，所示为横穿隔膜进入导管位于靠在上腔静脉壁上的位置时的情况；
图7为与图4一样的剖面图，所示为进入导管位于靠在卵圆窝上时的情况；
图8为与图4一样的剖面图，所示为当针刺穿卵圆窝时组织塞胀或“隆起”的情况；
图9为与图8一样的剖面图，所示为当扩张器前伸穿过卵圆窝时的组织塞胀的情况；
图10为与图9一样的剖面图，所示为伸出扩张器并穿过隔膜的护套；以及
图11为与图10一样的剖面图，其中已取出了扩张器，仅有护套留在穿过卵圆窝的位置上。
具体实施方式
参见图1，公开了一个依据本发明的扩张器20。扩张器20有一个近端22、一个末端24以及一根细长的柔性管状体26。扩张器20的总长根据经由皮肤的进入点和所要进行的应用而定。例如，在股静脉处经皮穿越腔室进入以定位并刺穿心脏内心房隔膜上某处时，通常使用长度在约80至约100厘米之间。
管状体26可以根据用来制造适于到达冠状动脉或心腔的导管的已知技术中的任何一种来制造。例如，管状体26可以是适合的生物相容的聚合材料挤压制造而成，这些聚合材料如高密度聚乙烯、聚四氟乙烯、尼龙以及多种其它该技术领域中的已知材料。也可以使用诸如带有约5％至25％的高密度聚乙烯(例如高密度聚乙烯/低密度聚乙烯的比例为50％∶50％、60％∶40％及其它)的混合材料，在一个实施例中，混合了20％的硫酸钡(BaSO4)以润滑和不让辐射透过。或者，至少管状体26长度的一部分或全长可以包括一个圈弹簧、实心壁的皮下注射针头管(例如不锈钢、镍钛合金)或者交织加强壁，如在导管和导向线技术领域中为人们所理解的那样。
对于大多数应用来说，管状体26的横截面形状大致为圆形，其外径在约0.020英寸至约0.200英寸的范围内。依照本发明的一个实施例，管状体26的外径沿着其全长均为0.160英寸左右。也可容易地采用其它的长度和直径，这取决于所要求的剖面形状和性能方面的特征。
近端22装有一个带一个或多个入口的多支管28，如该技术领域中已知的那样。在所述的实施例中，多支管28设有一个核芯线口32，它也可以或者替代地在一有额外导线的实施例中的用作一个导向线口。也可以再设置一个注射口30，以用来注射如用于确认末端24已穿过心房间隔膜的对比介质。如果需要，还可以设置其它的入口，这取决于导管所具有的功能。多支管28可用多种医用级别的塑料中的任何一种注模而成，或者根据其它的该技术领域中的已知技术来形成。
根据本发明的第一方面，近端22在多支管28处或多支管28末端处还设有一根诸如一光纤束35之类的通信线34。在本发明的一个实施例中，光纤束或信号发送线35与一个信号(例如声音、光、超声波或其它的振动等)发生装置和检测装置37进行通信。在本发明的这个实施例中，检测装置37使导管可以区分是实心组织还是厚隔膜或诸如卵圆窝之类的薄隔膜，以及在扩张器20末端之外的血液是右心房还是左心房腔的血液，这将在下文进行讨论。
柔性管状体26有一个预设的弯折25，以如人们在该技术领域中所理解地那样帮助末端24偏倚在心房间隔膜上。弯折25的半径最好在约0.5厘米至5厘米的范围内，在一个实施例中，其半径约为2.5厘米。弯折25的圆心位于一个从末端24向近侧约1厘米至约10厘米范围的一个点处。在一个实施例中，弯折25的中心位于从末端24向近侧约6厘米的位置处。弯折25由它与基本呈直线的扩张器20近侧部分相接的一个近侧过渡部分和它与基本呈直线的扩张器20的末端侧部分相接的一个末端侧过渡部分界定。弯折25的角度偏转一般在约30°至约80°的范围内，在一个实施例中，为约50°。
弯折25可以根据任何一种技术来设置。例如，在一个管状体26包括一支管或其它金属管的实施例中，管状体26可以绕诸如一根超过支管弹性极限的成形心轴来弯曲成形。或者，注模成形的导管状体也可以加热成形为一个预定的弯折，例如带有延伸过任何内腔的可移去的柔性心轴，以保持内腔在弯折周围的开放性。其它的技术对于那些熟悉本技术领域的人们来说都是已知的。或者，弯折25可以在将导管放置到心脏内的过程之中或之后形成。这可以通过为导管配备任何一种转向机构来完成，该转向机构能使导管的末端部分偏离导管的正常偏斜轴线。例如，一个或多个轴向可移动的拉伸线可以延伸过导管的整个长度。对在导管末端处固定的拉伸线的向近侧牵引就会致使导管的横向偏离。
请参见放大的示意图3，末端24至少设有一个信号发送面47和至少一个信号接收面49。发送面47适于从扩张器20的末端24发送信号，且一般沿着相对于扩张器向着末端方向发送。接收面49适于用来接收一个一般为沿着相对于扩张器20的末端24向近侧的方向传送的反射的返回信号。在一个实施例中，发送面47包括一根光纤或一个光纤束的末端，或者一个在单根光纤或光纤束末端处的透明窗口。类似地，接收面49也包括一根接收光纤的末端或一个位于接收光纤末端的透明窗口。在所述的实施例中，设置了两个发送面47和两个接收面49，它们中的每一个都通过一根唯一的通信线34与分光计37通信。
例如，可见光的发送和接收也可替代地通过单个透明窗口来完成，并且也设计了发送和接收信号是通过同一光纤或通过紧相邻的光纤来传送的实施例。通过同一光纤的发送和接收信号传送例如可通过在近端处准备一个接头以用来为在检测装置37中进行处理而分离发送和接收信号，尤其，血氧合检测技术领域的人们将会理解这些。或者，可以设置一个或多个分离的发送面47和接收面49，可以根据所要求的设置约1至约12的范围中的任意个数的各发送面47和接收面49。
这样，信号发送束35就为发送面47和接收面49之间提供通信，以及与一个诸如分光计之类的保持在病人体外的检测装置37通信。尤其，在脉冲氧合技术领域的人们能较好地理解分光计的构造和诸如测量红绿蓝色值(RGB)、其它紫外线(UV)、可见和红外(IR)波长之类的用途，它们将不在这里详细公开了。一般来说，发送/检测装置37能够发送多种波长的光线，这些光线传送到发送面47之外，并进入到扩张器20的末端24之外的一个目标体内。一些发送的光线被目标体吸收，而其它的光线则反射回来并在接收面49处被接收。之后，反射的光线就传送到光线检测装置37中以进行处理。本发明的发明者们已确定光检测装置17与本发明的扩张器相结合就能够根据在卵圆窝处所观察到的独特的光线特征确定何时扩张器20的末端24位于靠在心房间隔膜的卵圆窝的位置上，而不是位于其它隔膜或肌肉壁的位置上。
根据所发送光线的特征，在卵圆窝处的反射光线就显示出以下反射光线所赋予的独特的特征：(1)在卵圆窝表面或内部反射的光线；(2)通过卵圆窝由左心房中的血液所反射的光线；或者(3)前述反射光线的结合。光线检测装置根据通过卵圆窝所传送光线来定位卵圆窝的能力是基于若干种情况的。在右心房中的血液相对氧合较差，因此更蓝一点，而不太红。左心房中则容纳了氧合好的血液，这种血液相对较红。卵圆窝很薄，使在卵圆窝定位器尚位于右心房侧时，光线就能透过卵圆窝并射入左心房或从左心房射出。隔膜的其它区域一般很厚，不允许明显的光在右心房和左心房之间传送。这样，在本发明的一个利用透过卵圆窝的光线传送的实施例中，血液相对较红的位置表示传送入左心房中，且这样的情况一般仅会在卵圆窝处发生。
或者，隔膜包含氧合血，并因此发送一定程度的红光。但卵圆窝则是一片薄的半透明隔膜，且几乎呈黄色。在右心房中的非氧合血相对较蓝，而左心房中的氧合血则是红色的。因此卵圆窝的定位也可以通过确定一个半透明且近黄色的隔膜的出现来完成。使用多种波长、发送以及检测装置将能对卵圆窝的近黄色以及透过卵圆窝辨认出的红色进行评价，对于那些熟悉该技术领域的人们来说，考虑到这里所公布内容，这些是显而易见的。
本发明的方法还可以通过在左心房中设置一个光源来完成。左心房中的光源可设置在各种进入左心房的导管中的任何一个上，如对那些熟悉该技术领域的人们来说显而易见地那样。在左心房中所产生的光线将可在右心房中探测到，或是唯独在卵圆窝处有光或在卵圆窝处呈最大的亮度。这样，左心房扩张器20就仅需要设有光检测光学仪器和电子仪器，以基于从右心房的光源接收的光的特征来确定卵圆窝。
扩张器20还设有一个诸如针头44之类组织刺穿结构42。针头44最好包括一个诸如带有削尖末端50的不锈钢支管之类的管状结构。针头44的削尖末端50可轴向移动，并进入到管状体26末端24中的一个开孔45中。
在本发明的一个实施例中，针头44的轴向长度为约1厘米至约5厘米，其内径约0.022英寸，外径约0.032英寸。针头44也可以使用各种其它任一种尺寸，这取决于所要求的性能和整个导管的尺寸。针头44连接到一个诸如核芯线36之类的控制元件的末端40上，该核芯线36轴向可动地延伸过管状体26的整个长度。在所述实施例中，核芯线36的近端38从核芯线口32向近侧延伸。针头44最好在一个针尖50包含在管状体26的末端24内的第一位置和一个针头44的针尖50露出在管状体26的末端外(如为了刺穿卵圆窝)的第二位置之间轴向可动。核芯线36近端38的向末端前伸会将针头44从第一位置前推向第二位置，人们考虑到这里所公布的内容后会赞同这一点。或者，也可以除了在需要刺穿隔膜的时候，将针头44和核芯线36从扩张器20整个地移去。
如所述实施例那样，核芯线的近端38可以露出在核芯线口32近端的外面，使医生能够抓住核芯线36并向末端前推它至最佳的触觉反馈的位置上。或者，核芯线36的近端38也可以与各种各样诸如滑动开关、旋钮之类或其它的附着在多支管28上或与多支管28相邻的控制装置中的任何一种相连。操纵控制装置可使针头44在第一和第二位置之间可控制地往复移动。
在一个图6-10所公布的替代实施例中，针头44可移去地延伸过扩张器20的整个长度。对于这个实施例，针头44的轴向长度可在约100厘米至约120厘米之间或更长，在一个实施例中，约为110厘米。
在一个所述的实施例中，可以在中心内腔39及中空的针头44(如果存在的话)中注射不透辐射的染料，以确定扩张器20末端24的位置。或者，可以抽血并通过人们熟知的方法来分析氧含量。左心房的血的氧饱和度大于90％，而右心房的血的氧饱和度则小于80％。如果对于一个特殊的应用来说需要，还可以容易地设置一个独立的注射腔(未图示)。此外，针头44可以从扩张器20中移去。在这样的构造中，扩张器20就为前伸至心房间的进入处保持了它最大的柔性。一旦扩张器20的末端24位于左心房内时，诸如针头44之类的剌穿结构42可以加装到扩张器20的近端22中，并且向末端前伸过扩张器20的整个长度并从末端开孔45中伸出。一旦刺穿结构42刺穿了卵圆窝或其它的结构，并且扩张器20的末端穿过了由刺穿结构形成的开口，则刺穿结构42就可以向近侧撤回，并从扩张器中移去，从而使中心空腔可全部地为接下来的治疗或诊断装置或材料使用。
扩张器20的末端24最好设有一个渐收的截头圆锥面27。这使管状体26可用作一个扩张器，从而使渐收面27能扩大针头44形成的开口，并同时使横穿隔膜的进入过程中卵圆窝的“塞胀”最小。
根据本发明的方法，可以初始时就有一个横穿隔膜进入系统通过下腔静脉或上腔静脉进入到右心房中，这在初始时就要求带引导物护套的中空管，例如可通过人们熟知的“塞丁格氏”技术。本发明的横穿隔膜进入系统包括一个横穿隔膜的护套、一个如上所述的刺穿扩张器20以及一根合适尺寸的导向线。
在目前的实践中，尽管从左股静脉进入也是可能的，但较佳的进入点为沿着右股静脉。也可以通过刺穿其它任一条各种具有合适内直径的静脉来实现进入，本发明在这个方面并不受局限。
之后，一个传统的弹性倾斜导向线就穿过针头进入到静脉中，并且针头被移去。本发明的扩张器20置于一个诸如一14法国引导物护套之类的护套中。接着，护套和内部的扩张器20以及导向线就穿过股静脉进入到右心房。
请参见图4，图中所示为心脏60的一部分的示意剖面图。右心房62与下腔静脉64和上腔静脉66相通。心房间隔膜70将右心房62与左心房68分开。卵圆窝72位于心房间隔膜70上。如图4所示，其中带有扩张器20的护套74和一根导向线76已经位于右心房62内。
之后，导向线76就向末端伸出以进入上腔静脉66，参见图5。然后扩张器20和护套74伸入上腔静脉，如图6示意地所示。导向线76向近侧缩回。
当护套74和扩张器20在上腔静脉中且导向线已经移去时，一个横穿隔膜针头44就前伸穿过扩张器20和护套74的中心内腔39。横穿隔膜针头44前伸(可能在适当的位置上带有一根探针)到一个探针尖恰好位于护套74和扩张器20末端内部的点上，这个位置先前已被操作者注意到了，并且探针从横穿隔膜针头缩回。
然后，余下的护套74与其中带有横穿隔膜针头的扩张器20组件就被从上腔静脉向近端抽拉，同时在扩张器20末端区域处的预设弯折25使护套—扩张器—横穿隔膜针头组件的末端头沿着右心房的壁和隔膜70“拖动”。依据该横穿隔膜进入系统的特殊实施例，进入方法中在此时会有一些不同。
例如，在图1-3所公布的反射光线实施例中，一旦扩张器20已置于右心房62的内部但末端头还未靠在隔膜70上时，就有可能需要对光源和检测装置37进行校准。通过穿过护套74向末端前伸扩张器20的末端头，扩张器20的末端头就靠在了隔膜70。然后通过向近侧牵引扩张器20，末端头沿着隔膜拖动，直至它弹到卵圆窝72上。一旦末端头位于卵圆窝72上，检测装置37就能探测到卵圆窝处的特有色彩。响应的音频或视觉信号产生，确认导管20现在已正确地位于卵圆窝72处。
在整个过程中，一般用荧光检查或其它的可视技术在放置时协助医生。为了协助这样的观察，护套74的末端头和扩张器20的末端头可设有一个不透辐射的标记。此外，一些医生发现有必要在该过程的各个阶段的横穿隔膜针头中注入一种不透辐射的染料，以协助观察，特别是在横穿隔膜的刺穿之后。
当护套—扩张器—横穿隔膜针头组件的末端头已位于靠在卵圆窝72上的所要位置上时，横穿隔膜针头44就突然前伸以完成快速的剌穿，参见图8。一刺穿，就有一种医学技术来确定横穿隔膜针头44的尖端50已出现在左心房68内。确定对这样的横穿隔膜针头44的尖端50的位置可以通过监控通过横穿隔膜针头内腔所感知的压力以确认所测得的压力在所预计的范围内且具有左心房压力的典型波形特征来完成。或者，左心房68中的正确定位也可以通过分析从横穿隔膜针头44所抽出的血液中的氧饱和水平来确认；亦即，吸入完全氧合的血液。最后，仅通过荧光检查器观察或与染料的使用相结合，也可用来确认横穿隔膜针头44的针头50出现在左心房68中。
在将横穿隔膜针头50放置在左心房68内之后，扩张器20的端部27就前伸穿过隔膜70并进入到左心房68中。一般地，人们应注意保证在将扩张器和护套尖端前伸入左心房的同时，横穿隔膜针头44的尖端所前伸的距离应不足以使针头44伤及左心房68的相对侧壁。当扩张器20的渐收端部27显现已进入左心房68时，横穿隔膜针头44就缩回。然后，通过单单将护套74前伸过扩张器20或者通过将护套74和扩张器20一起前伸，护套74就前伸入左心房68内，参见图10。然后当护套74伸入左心房时，扩张器20就从护套74中缩回，从而使护套74的主要内腔可完全用作伸入左心房的其它治疗或诊断装置的通路。
尽管本发明是按照某些较佳实施例进行描述的，但对于那些考虑到本文公布内容熟知本技术领域的人们来说，其它的实施例就是显而易见的。因此，本发明的范围不局限于这里所公布的特殊实施例，而确切地应由后面所述的权利要求的全部范围来确定。

Claims (25)

1.一种定位卵圆窝的方法，它包括以下步骤：
将一根导管的末端头置于心脏中；
从该导管传送一个信号；
接收返回信号；以及
将尖端移动到一个返回信号指示为卵圆窝的位置上。
2.如权利要求1所述的定位卵圆窝的方法，其特征在于：传送一个信号的步骤包括传送一个超声波信号。
3.如权利要求1所述的定位卵圆窝的方法，其特征在于：信号传送步骤包括传送一个电磁信号。
4.如权利要求3所述的定位卵圆窝的方法，其特征在于：该电磁信号在紫外线一可见光的范围内。
5.如权利要求4所述的定位卵圆窝的方法，其特征在于：该电磁信号包括多种波长。
6.如权利要求1所述的定位卵圆窝的方法，其特征在于：该位置与卵圆窝接触。
7.一种横穿隔膜进入系统，它包括：
一个护套；
一个扩张器；
一个针头；以及
至少在护套、扩张器及针头中的一个上的一个信号发送面和一个信号接收面，以用来传输信号和接收返回信号。
8.如权利要求7所述的横穿隔膜进入系统，其特征在于：信号发送面和信号接收面包括同一表面。
9.如权利要求7所述的横穿隔膜进入系统，其特征在于：信号发送面包括一根波导线的末端。
10.如权利要求7所述的横穿隔膜进入系统，其特征在于：信号发送面包括一个转换器。
11.如权利要求10所述的横穿隔膜进入系统，其特征在于：信号发送面包括一个超声波转换器。
12.如权利要求7所述的横穿隔膜进入系统，其特征在于：它还包括一个与信号发送面相通信的多波长光源。
13.如权利要求12所述的横穿隔膜进入系统，其特征在于：它还包括一个与信号接收面相通信的光线检测装置。
14.一种用于定位卵圆窝的方法，它包括以下步骤：
使一导管与左和右心房之间的隔膜表面接触；
沿着隔膜移动该导管；以及
对表示该导管已位于卵圆窝处颜色进行监控。
15.如权利要求14所述的定位卵圆窝的方法，其特征在于：监控步骤包括检测光线。
16.如权利要求15所述的定位卵圆窝的方法，其特征在于：监控步骤包括检测紫外线。
17.如权利要求15所述的定位卵圆窝的方法，其特征在于：监控步骤包括检测可见光线。
18.如权利要求15所述的定位卵圆窝的方法，其特征在于：监控步骤包括检测红外线。
19.如权利要求15所述的定位卵圆窝的方法，其特征在于：监控步骤包括检测反射光线。
20.如权利要求17所述的定位卵圆窝的方法，其特征在于：该光线至少包括红光、绿光及蓝光中的一种。
21.如权利要求15所述的定位卵圆窝的方法，其特征在于：监控步骤包括检测从左心房中的光源传送来的光线。
22.如权利要求14所述的定位卵圆窝的方法，其特征在于：它还包括校准导管的步骤。
23.如权利要求14所述的定位卵圆窝的方法，其特征在于：它还包括导管将光线向末端发送至隔膜的步骤，以及通过导管将向近侧反射的光线发送到一个检测装置的步骤。
24.如权利要求23所述的定位卵圆窝的方法，其特征在于：它还包括产生响应于卵圆窝处反射光线的变化的标记的步骤。
25.如权利要求24所述的定位卵圆窝的方法，其特征在于：该标记包括一个声频或视觉信号。
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