CN1283212C - 用于切除身体组织的基于射频的导管系统和中空同轴电缆 - Google Patents
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Abstract
一种用于切除患者身体器官的生物组织的改进的射频导管系统,包括一个导管(3),一个设置在导管的末端的可伸出天线导向件(36),和一个安装在天线导向件上的射频(“RF”)天线(54)。RF天线包括一个容纳天线导向件的轴向通道,适用于接收和发射用于组织切除的RF能。在伸展时,天线导向件获得一种环形构造,该环形构造建立了与身体器官内部轮廓相符的身体器官的线接触,以便不管身体器官如何运动,都可限定精确的和固定的组织切除路径。天线导向件携带RF天线沿建立的组织切除路径伸出。利用辐射不透明标记和沿天线导向件安装的心内电极方便了环形与希望的组织切除路径对准。可以给导管以及天线提供用于引导通过身体器官通道的导向或偏转机构。本发明还提供了一种传送RF能的中空同轴电缆。
Description
本发明是美国专利和商标局当前未决的、1998年12月14日申请的、序列号为09/211,188的美国专利申请的部分后续申请。
发明背景/领域
本发明一般涉及射频(“RF”)供电的医疗装置和生物组织的切除。更具体地讲,本发明涉及用于切除患者身体器官内生物组织和治疗心律失常的基于导管的RF天线。
近年来医疗界广泛地接受了将医疗装置作为治疗心脏病和其它严重疾病的一种重要方式,这些疾病传统上是用药物或手术治疗的。心脏病治疗中出现了两种基本趋势。第一种趋势是从开心手术治疗向较小侵犯性的和较少花费的导管治疗转变,导管治疗是比较安全的,对身体损害也较小。
第二种趋势是从使用抗心律失常药物向最小侵犯性的导管或其它基于器械的诊疗转变,以缓和不可治愈的心律失常。例如,通常是将自动电复律器-电震发射器植入患有致命室性心律失常患者的体内,以减少猝死的可能性。因此,现在大量的心律失常患者使用射频(“RF”)导管切除。
尽管有这些技术上的进步,心房纤颤(“AF”)仍然是一种严重的问题。AF,一种由非均匀电脉冲诱发的心脏的心房或上腔的快速不规则心律,是中风和心脏病突发的首要原因和主要的健康问题。迄今为止,治疗AF的最有效外科传统方法一直是进行“开心”手术的Maze方法。在Maze手术中,沿心房外部预定线切开,然后再缝合切口。在愈合时,沿切开线形成疤痕,因而形成电脉冲的传导阻碍。通过建立这种阻碍,使AF不能持续,并恢复了正常心律。但是,由于Maze方法涉及包括打开胸腔和切断胸骨的危险和致命的开心手术,因此它不能广泛地适用。
导管射频切除技术代表着一种模仿Maze手术的新方法,其中不是进行手术切开,而是使用导管电极破坏或切除心房腔室内的心脏组织。如医疗领域中通常所做的那样,使导管电极穿过动脉以进入心房。在心房内,通常是借助于x-射线或荧光检查装置使导管电极的尖端定位,并使之与需要切除的恰当位置或点的心脏组织接触。从导管电极产生的电阻热在该点破坏心脏组织。此后,把导管电极重新定位在下一个切除点。因此,一系列的切除点类似于在Maze手术下完成的阻碍电脉冲传导的直线伤痕。
可以认为现有的导管切除手术比“开心”手术的侵入性小。此外,在切除过程中,减小了对心血管功能的破坏。但是,成功的导管射频切除手术通常需要使组织切除点的间隔或者说相邻点之间的最小公差小于2毫米,以防止电脉冲通过。出于这种考虑,精确地定位导管电极的任务是成功手术的关键因素。
这种现有方法的主要缺点在于,在心腔肌肉搏动的同时,在心房内恰当的切除点定位导管电极是一项耗时的任务。心房壁或心肌的运动通常使导管电极难于定位,并可能发生导管电极滑动,因而可能损伤不希望切除的心房部分。结果,不能有效地完成基于导管的RF切除的定位,并且可能需要超过12小时的长的手术时间。此外,在手术过程中,通常使用x-射线或其它放射装置引导和定位导管电极,电生理学规定这要使用沉重的铅防护设备。结果,长的手术时间通常又使这种不便更为突出,这妨碍了导管电极作为一种有效的组织切除装置来使用。
为了减小滑动的危险,例如,第5,741,249号美国专利披露了一种基于导管的微波天线,其中末梢顶端结合在一个天线中,以将其锚固在心房壁上。但是,尽管这种设计减小了每个切除步骤期间的天线或导管电极滑动的可能性,但是它没有消除每个切除步骤中沿希望的切除路径精确定位天线的耗时任务。因此,在每个切除步骤之后,必须把天线重新定位和精确锚固到下一个点,如上所述,该点必须定位在切除路径上的一个空间或最近的公差内。
因此,利用导管切除有效治疗心房纤颤需要在心房的内表面建立长的或重叠的直线或曲线的切除伤痕。这些伤痕可以起到阻碍电脉冲传导的作用,因而防止了心房纤颤。
还认识到对于心房纤颤进行有效的基于导管的切除的关键要求是要把导管和微波天线稳定和锚固在心房腔室内。为了开发最小侵入性的基于导管的心房纤颤治疗方法,需要新的、最好是能够产生长的或重叠的直线或曲线切除伤痕的导管切除系统。
本发明提供了这种导管系统的设计,它不仅可以用于心房纤颤,而且可以用于在其它身体器官中的生物组织的切除。该导管系统包含利用单轨和环形天线导向件的稳定和锚固机构,用于在切除过程中监测不同参数的传感器,和带有控制滑动件以容易地引导和操纵导管的手柄。
发明概述
根据本发明,提供了一种用于切除包括患者的心房在内的身体器官的生物组织的改进的射频导管系统。导管系统包括一个适用于插入身体器官中的导管,和一个设置在导管内腔中的可伸展的天线导向件。在导管的末端提供了一个可伸展的射频天线,以及一个中空同轴电缆,以接收和发射用于组织切除的射频能。在本发明的一个代表性的实施例中,天线包括螺旋线圈,并且具有容纳天线导向件的轴向通道,在它伸展时规定了组织切除的天线的切除路径。天线导向件包括固定于用于定位和伸展控制的控制滑动件的细长部分。天线导向件可以在身体器官内伸展,以形成一个符合身体器官轮廓的环形构造。可以利用辐射不透明标记和沿天线导向件安装的心内电极帮助环形与希望的组织切除路径对准。在身体器官内形成环形之后,使射频天线沿天线导向件伸展,进行组织切除。
在本发明的一个替代实施例中,把天线导向件的细长部分的一端固定于定位控制滑动件,并把另一端固定于导管的末端部分。作为本发明的另一个替代实施例,将天线导向件形成为一个细长挠性元件,其具有终止于一个末梢顶端的附接的末端部分。
本发明的射频导管系统也可以结合各种不同的替代射频天线设计。在本发明的一个这样的替代实施例中,射频天线包括一个设置在导管末端部分的单极珠,用于传送优化辐射图形,同时使反射和电压驻波比最小。在本发明的另一个替代实施例中,提供了一种微带挠性电路。
在应用中,使天线导向件从导管内腔伸展出来,以建立与身体器官内表面的接触。天线导向件的挠性使它能够弯曲成符合身体器官的轮廓,以限定射频天线的切除路径。
即使没有完全避免对现有技术的切除导管电极的反复微小精确定位的需要,本发明也有效地减轻了这一需要。本发明可以方便地沿限定了组织切除路径的天线导向件的轨迹放置射频天线。同时,本发明还确保了连续的切除路径,并且实际上减小了现有技术中切除点之间电脉冲泄漏的危险。因此,本发明实际上在取得曲线形伤痕方面完成Maze方法的目的,而无需开心手术。从以下的详细说明和附图中可以更清楚地了解本发明的这些和其它方面和优点,附图以示例的方式说明了本发明的特征。
附图的简要说明
图1是本发明的射频导管切除系统,连同射频功率模块、计算机控制和数据记录装置的概念图;
图2是本发明的射频导管切除系统的透视图;
图3A是在射频导管切除系统的末端部分伸出状态的天线导向件和射频天线的剖面图;
图3B是在射频导管切除系统的末端部分缩回状态的天线导向件和射频天线的剖面图;
图4A是射频导管切除系统的末端部分的局部剖视图;
图4B是射频导管切除系统的另一个实施例的末端部分的局部剖视图;
图5是射频天线的剖面图和天线导向件的局部视图;
图6是沿图5的6-6线的剖视图;
图7是本发明的另一个实施例的透视图;
图8是导管系统的末端部分的典型横截面图;
图9是用于射频天线和射频能量源之间的电连接的微带的平面图;
图10是图9的微带的正视图;
图11是射频导管切除系统的局部剖视图;
图12是射频导管切除系统中使用的手柄架的局部剖视图;
图13是设置在图12的手柄架中的微带的横截面图;
图14是结合一个单极射频天线设计的本发明的另一个实施例的局部剖视图;
图15是结合一个微带挠性电路射频天线设计的本发明的另一个
实施例的局部剖视图;
图16是沿图15的16-16线的微带挠性电路的横截面图;
图17是在射频导管切除系统中使用的本发明的中空电缆的末端部分的局部剖视图;
图18是结合一个或更多的导向线的本发明的导管的末端部分的局部剖视图;
图19是被一个或更多导向线偏转的本发明的导管的末端部分的另一个局部剖视图。
本发明的详细说明
本发明提供了一种在患者身体器官内切除生物组织的改进的射频导管系统。系统包括一个适于插入患者身体器官中的导管。它结合一个用于向治疗部位传送电磁能的可伸展射频天线。提供了一种用于使天线沿希望的切除路径精确定位的单轨导向件。本发明还提供了一种用于传导电磁能的中空同轴电缆。
如图1,2和3中所示,本发明包括一个适用于插入患者的身体器官内的导管3。导管具有一个带有一个近端部分12和一个末端部分14的挠性细长管体10。内腔16从导管的近端部分延伸到带有末端开口18的末端部分(图3和4)。位于导管3近端部分12的是一个用于容纳如下面将更详细说明的必要的导向和定位控制件的手柄架20。结合在导管3近端的是一个用于连接支持切除过程的的各种电极(未示出)的耦合件22。
导管3的尺寸根据适合特定医疗过程的需要适配,这在医疗技术中是已知的。导管的管体10一般是由与身体器官环境生物相容的聚合物材料构成的。这些材料的例子包括,具有不同程度的辐射不透明性、硬度和弹性的,来自德国Autochem公司的Pebax,聚乙烯,聚氨基甲酸乙酯,聚酯,聚酰亚胺和聚酰胺。
在本发明的一个实施例中,导管3是利用一种或多种上述材料的多个段形成的,因而使导管体向其末端逐渐地更具有挠性。通过热粘结、对头连接或粘结剂粘结把各段结合在一起。可以给管体10的外圆周表面加上编织加强层,以使导管获得希望程度的硬度和抗扭强度。这使导管能够前进和穿过患者的身体器官,并使导管能够沿导管的长度从近端部分到末端部分扭转输送。
导管3的末端部分14是由带有很少或没有编织加强物的较软的聚合化合物构成的,以便在操纵导管通过动脉或静脉之类的身体器官的狭窄通道时,提供希望的挠性以容许导管的末端偏转或导向。在本发明中,导管的导向是用一个拉线30实现的,如图11中所示,拉线30从控制手柄架20延伸到导管3的末端部分14。在导管3的末端,用焊接或其它适当的方法把拉线30固定在导管内腔16的内壁上。
拉线30在近端固定在偏转控制操纵杆或按压滑动件32上,按压滑动件32可滑动地啮合于手柄架20的纵向缝隙34。按压滑动件32沿缝隙34的纵向运动结合导管3的扭转运动使医生能够根据需要弯曲或伸直导管3,以便引导导管3通过身体器官的通道。结合于按压滑动件32的是一个用于将操纵杆在缝隙34中的位置的摩擦固定装置。在市场上可以买到许多种类的这种装置。这种装置的例子包括,set-release,压力开关或自锁机构等。
本发明的导管系统1提供了一种用于沿预定切除路径引导组织切除RF天线的有效装置。图1,3A,4A和4B示出了在邻近导管3的末端部分14的延长位置上伸出的天线导向件或单轨36。如图3B中所示,天线导向件或单轨36也可以缩回到导管内腔16中。
在本发明的一个实施例中,单轨36包括一个挠性细长元件,它可以由带状材料构成。作为选择,单轨36也可以如附图中所示的那样由小直径管材制造。单轨36有向近端延伸到导管内腔16中的延长部分42和44(图4A,8-10)。在手柄架20,单轨延长部分固定到各自的控制滑动件46和48。与导管偏转拉线30类似,控制滑动件46和48可滑动地啮合在手柄架20上的纵向缝隙中,如图2中所示,并且可以沿导管3的纵轴向末端或近端运动。因此,通过移动一个或两个控制滑动件,单轨导向件可以建立一个如图2和图3A中所示的伸出位置,或如图3B所示的缩回位置。为了伸出单轨36,将一个或两个控制滑动件46和48相对于手柄架20向末端移动。为了缩回,将控制滑动件向近端方向移动。可以用适当的装置固定控制滑动件的位置,例如,加载弹簧摩擦固定装置等,如同偏转控制或按压滑动件32所用的那些装置。
图3B示出了在完全缩回位置上的单轨36,在这个位置上它在导管3的末端部分14的导管内腔16中被安排为一种压紧的U形状态。单轨36带有一个平的或弯曲的顶端40,从而在缩回位置上,顶端40实际上封闭了导管3的末端开口18,使导管内腔16与生物外界环境隔离。顶端40也使导管成为“无创伤的”,并且给导管提供了一个平滑的末端轮廓,以使它在通过身体器官的通道时减小刺穿身体器官的危险。
顶端40可以用通常用于构成导管的可与生物机体相容的材料制造。此外,它可以加入一种辐射不透明材料,以帮助用x-射线或其它荧光检查装置识别它在身体器官中的位置,如现有技术中通常使用的那样。
单轨36是由具有适当程度的记忆能力、生物相容性和类弹簧结构特性的金属或聚合物组中的材料构成的。这些材料的例子包括:镍钛金属化合物(镍-钛),不锈钢,聚酰胺和聚四氟乙烯(“PTFE”)。根据需要可以对使用的金属材料进行热处理或冷加工,以提供希望的结构特性,例如硬度和挠性。这些结构特性使得可以在导管内腔16中移动单轨36而不皱缩。但是,在导管内腔16外部的它的伸出位置,单轨36是可以挠曲的。
单轨36在身体器官内可以伸出到导管3的末端开口18以外,形成一个实际上连续的环50,如图3A,4A和4B中所示。控制滑动件46和48向导管3的末端的纵向前进,可以使单轨伸出,从而使单轨伸展到导管末端开口18之外,建立与身体器官内壁的接触。在接触时,单轨36的伸出部分将弯曲,获得一种环形构造。根据需要治疗的身体器官的内部轮廓,通过调节控制滑动件的末端位移量可以适配环形50的大小,从而使单轨符合身体器官的轮廓。单轨36的类弹簧特性使环形50的至少一部分能够支撑在身体器官壁上,从而获得与身体器官内壁的线接触,尽管它可能在运动。顶端40进一步帮助单轨36锚固在身体器官内壁上的裂隙或小凹陷处,而没有在身体器官上造成刺穿的危险。
为了当单轨36在身体器官内前进时确定它的位置,可以将一个或多个辐射不透明标记安装在单轨36上。如图1-4中所示,一个辐射不透明标记结合在单轨36的顶端40中。利用辐射不透明材料,顶端40在x-射线或荧光检查下成为不透明的,从而在导管插入或组织切除过程中帮助识别它的位置。这种辐射不透明标记的结构和使用在现有技术中是已知的,这里不再进行详细的说明。
作为一种设计上的变型,可以用末端结合在一起形成一个单轨的两个独立的细长元件构造天线导向件。两个细长元件之间的结合角度可以根据特定应用所需的单轨外形预先确定。因此,例如,在身体器官的窄小内腔内手术使用的小外形(具有超小横截面)导管,细长元件可能需要相对小的结合角度,以便利导轨的缩回和伸出。图4B示出了本发明的另一个实施例,其中单轨导向件36a的一端固定在导管3的靠近末端开口18处。结合一个延伸部分44a的单轨36a的另一端在手柄架连接于一个控制滑动件(未示出)。这个实施例可以在手柄架用一个单一控制滑动件使单轨伸出和缩回。
如图2-7中所示,本发明包括设置在导管3的末端部分14附近的用于组织切除的射频(RF)天线54。在本发明的一个代表性实施例中,RF天线54包括一个以螺旋形式缠绕形成一个螺旋线圈56的导电材料或导线带。如本技术领域中众所周知的,适当的线圈缠绕直径,间距和长度,以及导电材料或导线带的挑选是设计的选择事项,它们根据特定处理过程的要求可以改变。
如图2,3和4A及4B中所示,RF天线54包括螺旋线圈56,它定义了容纳单轨36的轴向通道58。RF天线54可滑动地安装在单轨36上。因此,单轨规定了它的运动。
为了提高形状的整体性,为RF天线54提供了一个管衬或套管60,其具有一个从螺旋线圈56向近端延伸到导管3的近端部分12的可弯曲延长体。套管60是由介电材料构成的,其减小了螺旋线圈56的金属表面与通道58中体液之间的电短路的可能性,并且帮助限制电磁场泄漏到通道之外。
如图5和6中所示,螺旋线圈56在接触点65连接到第一或内导电元件或导体64,导体64又电连接到RF功率控制源5提供的RF能源。在图5,6,11和17所示的实施例中,内导体64由可弯曲网或编织导线结构构成,或是由一个薄膜导电材料构成,内导体64围绕在套管60的外表面62上,并且从螺旋线圈56向近端延伸到手柄架20。在这个实施例中,内导体64呈现为一个细长管形构造。
内导体64沿其外圆周表面和向近端延伸到手柄架涂覆有一个聚合物介电保护涂层68。保护涂层68用作螺旋线圈56和一个第二导电元件或外导体66的基层。保护涂层68也使内导体64与外导体66电绝缘。
如图5和6中所示,螺旋线圈56绕在保护涂层68的外圆周表面上,并且在接触点67连接到外导体66。外导体66又电连接到RF功率控制源5提供的RF能量源。
在图5和6所示的实施例中,外导体66是由围绕介电保护涂层68的导电材料构成的,并从螺旋线圈56向近端延伸到手柄架20。外导体可以由编织导线结构或薄膜导电材料构成。
如图5中所示,螺旋线圈56沿其外圆周表面涂覆了一个聚合物介电密封层70,以保证螺旋线圈的结构整体性,和防止螺旋线圈与生物环境接触。密封层70是由硅或基于聚合物的材料或橡胶化合物之类的适当材料构成的。同样,提供了用类似材料构成的一个外套管72,以封装外导体66,和提供对生物环境的电磁和热隔绝。
如图11中所示,外套管72连接到一个微带80,微带80可滑动地固定于手柄架20,用于在近端部分使RF天线轴向位移,在下面将进行更详细地说明。单轨36的延长部分44在通道58内向近端延伸到导管3的近端部分12。因此,本发明提供了一组电导体,它们的每个都形成在一个细长的管状结构中,并且基本上以同轴对准的相互关系排列,形成了一个从螺旋线圈56向近端延伸到手柄架20的用于传送RF能量的中空电缆。
RF天线54适用于接收和辐射来自一个射频能源(未示出)的电磁能。适当的射频频谱的例子为大约300mHz以上的微波频率范围的频谱。RF天线能够施加由螺旋线圈发射的实际上均匀分布的电磁场能。发射的电磁场的功率实际上垂直于RF天线的纵轴,并且因此产生了环绕天线并以天线定界的均匀能量场。为切除而传送的能量沿天线均匀分布,与天线与被切除组织之间的接触无关。结果,与现有技术的点传导或电阻切除导管相比,本发明减小了切除过程中在器官中和邻近或接触的血液中产生热点的可能性。
在手柄架20,内导体64和外导体66以连接到一个阻抗匹配微带80的各自的连接板74和76为终端(图11-13)。连接板又连接到一个导电体82,例如一个从手柄架20经过接线器22延伸到一个电磁能源(未示出)的实心同轴电缆。在微带,单轨36穿出RF天线的套管60,这使它能够连接到一个控制滑动件。
微带80沿容纳在手柄架20中的装配块92a和92b的相对侧壁88和90上的侧槽84和86可滑动地啮合。为了提供RF天线的轴向运动,可以使电缆82相对于手柄架向末端或近端运动,以伸出或缩回RF天线。作为选择,可以将微带80固定于一个可以沿手柄架20上纵向缝隙移动的定位滑动件(未示出)。
如上所述,通过辐射不透明标记可以帮助恰当地放置导向元件。此外,可以给单轨36提供一个或多个心内心电计(“ECG”)电极96,使医生能够在组织切除之前和之后获得最佳组织贴近度和导电性,以及获得它们活动的反馈信息。这些电极沿单轨36的长度方向固定。图3A示出了一种心内电极96的典型安排,心内电极96电连接于设置在单轨36内的导体,以使其终端连接到导线连接器22中的信号插脚(未示出)。
导管可以通过一个开口插入到患者的身体器官中,在患者的身体器官中使导管贴近要切除的目标组织。在插入导管之前,将导向元件36和RF天线54缩回到导管内腔16中,利用辐射不透明标记40获得一个无创伤的顶端结构,以利于导管平滑地通过。然后,将导管3的末端部分14插入到身体的开口中,并且进行操作以到达需要切除的部位附近。方向控制是通过手柄架上的旋转动作和使用偏转控制件32完成的。
辐射不透明标记40便利于RF天线导向元件或单轨36的放置,如本技术领域中通常使用的,可以用适合的x-射线或荧光装置检测辐射不透明标记40的位置。在把导管3的末端部分14放置在组织切除点附近后,用控制滑动件使单轨向末端方向移动,从而使其伸出导管内腔开口16,获得上述的延长或伸出位置环形构造。
根据身体器官的内部形状和尺寸,可以操纵一个或两个单轨控制滑动件,以获得恰当的单轨环形尺寸或轮廓。用心内ECG电极96进一步帮助取得环形尺寸或轮廓,使医生将RF天线导向件或单轨36对准希望切除的路径。
例如,在心脏的心房情况下,可以调节环形50的尺寸,符合心房内壁的轮廓,以使环形50的至少一部分能够靠在心房壁上,这建立了心房与单轨之间的线接触。单轨36的挠性使环形的至少一部分能够符合身体器官的内部轮廓,并靠在其内壁上。随心房壁的搏动,与心房壁接触的单轨也将一致地运动,因而取得了与希望进行处理的身体器官的固定和稳定的定位关系。
一旦获得了单轨的环形轮廓,并且与希望切除路径平行对准时,将控制滑动件46和48固定在手柄控制器的原位。然后使RF天线54向末端移动,伸出导管的末端开口,并用单轨滑动引导,达到需要切除的精确位置。此后,通过施加射频能可以完成组织切除。根据特定的处理要求,通过使RF天线沿环形的不同位置的定位,然后施加RF能量,可以调节切除的长度。因此,可以建立长而连续的切除线,实际上消除了切除组织路径之间的电脉冲泄漏。根据特定处理要求,可以对心房内其它位置按需要重复上述步骤。
图7示出了本发明的另一个实施例,它结合了天线导向件设计的一种变型。在本实施例中,天线导向件102包括一个具有可分离的末端部分104的细长挠性元件,末端部分104以一个末梢顶端106为终端。末梢顶端106结合有一种辐射不透明材料,以便如上面所述的那样帮助导管的放置。导向件102的另一端向近端延伸到手柄架(未示出),并如前面所述实施例一样的方式固定于一个定位控制滑动件(未示出)。类似地,在其伸展之前,可以将天线导向件102与RF天线110一同缩回到导管100的内腔中。
在使用中,把导管100放置在要切除的组织附近之后,使天线导向件102伸出导管内腔108,使末梢顶端106能够锚固在身体器官表面上的裂隙中。天线导向件102的挠性使它能够弯曲,以附合身体器官的轮廓,和建立导向件102与身体器官之间的线接触。结果,就可以使导向件102与身体器官之间的任何相对运动减至最小。此后,天线导向件102可以携带RF天线110伸展到导管内腔108之外,沿基本上与天线导向件102和身体器官之间的线接触平行对准的路径进行切除。
作为替代实施例,本发明的射频天线可以结合射频天线的各种不同设计。图14示出了一个这样的替代实施例。如图14中所示,作为上述螺旋线圈构造及其替代的替代,给导管系统提供了一个包括一个单极珠122的天线120。单极珠在天线120末端环绕套管60外圆周设置。套管60具有一个内腔58,以容纳导向元件,例如,如上所述的导向元件或单轨36或天线导向件102。
单极珠连接于内导体64,内导体与外导体66电绝缘。如上所述,当给内导体64和外导体66加电时,在单极珠122与天线外部的外导体66之间产生一个电磁场,该电磁场可以用于组织切除。因此,尽管单极珠122与外导体66之间没有物理接触,但可以认为它们被电耦合连接,以产生电磁场。
适当地设计单极珠122的形状和尺寸,以优化辐射图形,同时使反射和电压驻波比(“VSWR”)最小,如在本技术领域中所公知的那样,实现提供了供给RF能量的传输线路与RF能量辐射的介质之间的平稳阻抗过渡的阻抗匹配功能。优选地是适当地设计单极珠122的形状和尺寸,以使天线系统的反射系数最小,因而使得VSWR减小到大约1∶1。例如,单极珠122的直径向其末端方向逐渐增大,并且以减小的直径终止在套管60的末端开口,从而大致形成一个泪滴形,如图14所示。
如上所述,内导体和外导体都适用于连接到一个RF能源。当加电时,产生的电磁场从外导体延伸到正交和全向于单极珠表面的单极珠顶端。发射的电磁场功率实际上垂直于RF天线的纵向轴,因而产生了一个环绕天线并以天线为界的均匀能量场。
作为本发明的再一个替代实施例,射频天线可以结合一个微带挠性电路设计,作为上述螺旋线圈或单极珠的替代。如图15和16中所示,微带挠性电路天线132包括一对设置在介电背衬69上的天线末端的相互间隔的导电微带134和136,背衬69是用作内导体64涂层的介电材料68的部分,或套管60的延长部分。微带134和136分别连接于内导体64和外导体66,因而在加电时能够在两个微带间产生电磁场,该电磁场可以用于组织切除。
适当地确定微带134和136之间的间隔和尺寸,从而可以在技术上取得从导体64和外导体66和被切除的身体器官的实际上平稳的阻抗过渡。因此,最好如技术上所知那样,将微带挠性电路天线设计为使反射VSWR最小。微带导体的尺寸应当足够小,以容许根据组织切除的需要以上述方式弯曲和偏转。
构造单极或微带导体中使用的材料包括生物相容的导电材料,这些材料的例子有铂、金或银,或它们的任意组合,这些材料是生物相容的。作为选择,在形成单极珠或微带导体时,也可以使用涂覆生物相容材料的其它导电材料。
作为选择,如图18和19中所示,可以安装一个或多个导线140与本发明的RF天线138末端部分的一个或多个电极142连接,以提供一种能够在组织切除之前和之后获得最佳组织相邻程度和导电性测量值的装置。
此外,本发明的天线可以包括一个或多个固定在天线末端部分的天线偏转或导向线,以获得更明显的天线形状或曲率。图18和19示出了一个示例实施例,其中一个偏转线144固定于天线138的末端部分146,并在中空同轴电缆内腔中向近端延伸,以便连接到手柄处偏转控制机构(未示出),并且由这个控制机构控制。在天线末端部分146连接偏转线144使得能够在该部位增大天线的偏转,如图19中所示。在使用中,如上所述,可以借助于导向元件或单轨36把带有这种偏转装置的天线138伸入到体腔中。在需要时,可以把导向元件36缩回,然后拉动偏转线144,实现射频天线的增大的偏转。结果,可以用这样的方式使天线变形,以便能够进入用其它方式不能进入的心房或其它身体器官的区域。
从上面的说明中可以了解到,本发明虽然没有消除现有技术的切除导管电极所需要的反复微小精确定位,但也减轻了这一需要。本发明可以方便地沿限定了组织切除路径的天线导向件的轨迹放置RF天线。同时,本发明也保证了连续的切除路径,并实际上减小了现有技术的切除点之间电脉冲泄漏的危险。因此,本发明实际上达到了获得直线伤痕的Maze方法的目的,而又无需开心手术。
尽管本发明是根据本发明的实施例和应用实例说明的,但可以进行各种修改和改进,而不脱离本发明的精神和范围。
Claims (25)
1.一种用于切除患者身体器官内生物组织的基于射频的导管系统,包括:
a)适用于插入患者身体器官中的导管,该导管具有一个近端部分,一个带有末端开口的末端部分,和一个从近端部分延伸到末端部分的内腔;
b)一个设置在导管内腔中并且可以伸出到导管末端开口以外,形成基本上符合身体器官的内部轮廓的环形的细长天线导向件;和
c)一个设置在导管末端并且具有容许天线导向件从中滑动通过的通道的射频天线,射频天线适用于接收和辐射射频能,用以沿生物切除路径切除生物组织。
2.根据权利要求1所述的导管系统,进一步包括电连接于射频天线并且在导管内腔中向近端延伸到导管近端部分的电导体。
3.根据权利要求2所述的导管系统,其中电导体适用于传导射频能。
4.根据权利要求1所述的导管系统,其中射频天线进一步包括限定了轴向通道的管状套管。
5.根据权利要求2所述的导管系统,其中电导体中的至少一个是由一个细长管状材料形成的。
6.根据权利要求2所述的导管系统,其中每个电导体都是由细长管状材料形成的,并且基本上按同轴对准的相互关系排列,形成一个中空电缆。
7.根据权利要求2所述的导管系统,其中电导体中的至少一个是由导电导线网材料形成的。
8.根据权利要求2所述的导管系统,其中电导体中的至少一个是由一种导电编织材料形成的。
9.根据权利要求2所述的导管系统,其中电导体中的至少一个是由一种导电薄膜材料形成的。
10.根据权利要求1所述的导管系统,其中天线导向件具有在导管内腔中向近端延伸的延长部分。
11.根据权利要求1所述的导管系统,其中天线导向件是由管状材料构成的。
12.根据权利要求1所述的导管系统,进一步包括至少一个安装在天线导向件内的心内心电计电极。
13.根据权利要求1所述的导管系统,其中天线导向件是由多个结合在一起形成单个单轨的细长元件构成的。
14.根据权利要求1所述的导管系统,其中天线导向件进一步包括至少一个由辐射不透明材料形成的末端顶端。
15.根据权利要求1所述的导管系统,其中所述细长天线导向件可滑动地设置在导管内腔中并且具有一个固定于导管末端部分的第一端部分和一个在导管内腔中向近端部分延伸的第二端部分,所述天线导向件可以伸出到导管的末端开口之外,形成一个具有符合身体器官内部轮廓的部分的环形。
16.根据权利要求1所述的导管系统,其中所述细长天线导向件可滑动地设置在导管内腔中和可伸出到导管的末端开口以外形成与身体器官线接触、并且基本符合身体器官轮廓以定义一个生物切除路径。
17.根据权利要求16所述的导管系统,其中天线导向件进一步包括由辐射不透明材料构成的至少一个末梢顶端。
18.根据权利要求16所述的导管系统,其中天线导向件是由管状材料构成的。
19.根据权利要求15所述的导管系统,其中射频天线包括一个定义了容许天线导向件可滑动地从中通过的通道的螺旋线圈。
20.根据权利要求16所述的导管系统,其中射频天线包括一个定义了容许天线导向件可滑动地从中通过的通道的螺旋线圈。
21.根据权利要求15所述的导管系统,其中天线包括一个具有容许天线导向件可滑动地从中通过的通道的微带挠性电路。
22.根据权利要求16所述的导管系统,其中天线包括一个具有容许天线导向件可滑动地从中通过的通道的微带挠性电路。
23.根据权利要求15所述的导管系统,其中天线包括一个环绕管状套管的单极。
24.根据权利要求16所述的导管系统,其中天线包括一个环绕管状套管的单极。
25.根据权利要求1所述的导管系统,进一步包括固定在天线的末端部分并且向天线近端延伸的至少一个细长偏转线,偏转线可用于使天线的末端获得偏转。
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US09/211,188 US6190382B1 (en) | 1998-12-14 | 1998-12-14 | Radio-frequency based catheter system for ablation of body tissues |
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CNB998028908A Expired - Lifetime CN1283212C (zh) | 1998-12-14 | 1999-12-08 | 用于切除身体组织的基于射频的导管系统和中空同轴电缆 |
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EP (2) | EP1054639B8 (zh) |
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KR (1) | KR100550164B1 (zh) |
CN (2) | CN100558308C (zh) |
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AU (1) | AU3115200A (zh) |
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EP1054639A4 (en) | 2001-11-21 |
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CN1290148A (zh) | 2001-04-04 |
CN1943523A (zh) | 2007-04-11 |
CA2321413A1 (en) | 2000-06-22 |
JP4340320B2 (ja) | 2009-10-07 |
EP1054639B1 (en) | 2005-06-08 |
EP1568331A1 (en) | 2005-08-31 |
KR20010040944A (ko) | 2001-05-15 |
JP2008206994A (ja) | 2008-09-11 |
DE69941308D1 (de) | 2009-10-01 |
AU3115200A (en) | 2000-07-03 |
EP1054639B8 (en) | 2005-08-03 |
ATE297167T1 (de) | 2005-06-15 |
EP1054639A1 (en) | 2000-11-29 |
KR100550164B1 (ko) | 2006-02-08 |
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