CN103908336A - 用于双向致动的具有单根牵拉线的双环套索 - Google Patents

用于双向致动的具有单根牵拉线的双环套索 Download PDF

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Publication number
CN103908336A
CN103908336A CN201310751846.4A CN201310751846A CN103908336A CN 103908336 A CN103908336 A CN 103908336A CN 201310751846 A CN201310751846 A CN 201310751846A CN 103908336 A CN103908336 A CN 103908336A
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China
Prior art keywords
deflection
distally
conduit
far
supporting member
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CN201310751846.4A
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CN103908336B (zh
Inventor
J.布伊
O.加范
J.吉梅内兹
T.阮
R.帕迪拉
T.V.塞基
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Biosense Webster Israel Ltd
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Biosense Webster Israel Ltd
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Abstract

本发明提供了一种具有远侧组件的导管，所述远侧组件具有带有环形电极的至少一个(如果不是两个)套环。所述远侧组件具有由挤出成型件覆盖的细长支撑构件，所述挤出成型件具有两个内腔，一个内腔的尺寸设定成用于与所述支撑构件防滑地紧密配合。将用于双向挠曲的单根连续牵拉线预弯成两个长的部分并在所述两个长的部分之间预弯成U型弯头。所述U型弯头在可挠曲节段的远端处锚定，所述可挠曲节段的远端由具有至少两个孔的至少一个垫圈增强，每个孔与所述可挠曲节段中的相应内腔轴向对齐。每个孔与内腔呈中心对齐，使得穿过其中的每个牵拉线部分为直的，且仅经受张力。使所述支撑构件的近端变平，并且呈锯齿状，以为所述可挠曲节段的远端提供更好的粘结。

Description

用于双向致动的具有单根牵拉线的双环套索
技术领域
本发明涉及一种改进的消融导管，其尤其可用于在心脏的管状区域中或接近心脏进行标测或消融。
背景技术
电极导管已普遍用于医疗实践多年。它们被用于刺激和标测心脏中的电活动，以及用于消融异常电活动的部位。心房纤颤是一种常见的持续性心律失常并且是中风的主要原因。这种病症由于在异常心房组织基质中所传播的折返性子波而长期存在。已开发出各种方法来中断子波，包括外科手术或导管介导的心房切开术。在治疗该病症前，必须首先确定子波的位置。已提出各种技术用于此类确定，包括使用具有远侧组件的导管，所述远侧组件适于测量肺静脉、冠状窦或其他管状结构内有关该结构的内周边的活动和／或进行消融。一种此类远侧组件具有管状结构，该管状结构包括大致横向于导管轴、且位于导管轴的远侧并具有约360度的外圆周的大致圆形的主要区域，以及位于所述主要区域远侧的大致直的远侧区域。管状结构包括该远侧组件的至少主要区域之上的非导电覆盖件。在该标测组件至少主要区域内设置具有形状记忆的支撑构件。多个电极对由该远侧组件的大致圆形的主要区域承载，每个电极对包括两个环形电极。
在使用时，将该电极导管插入已经定位在主静脉或主动脉(如股动脉)内的导引护套内，并引导进入心室。在心室内，使该导管延伸经过导引护套的远端以暴露远侧组件。通过移动(包括该导管的远侧部分的挠曲)来操纵该导管，使得远侧组件被定位在心室中的管状区域处。控制导管的精确位置和取向的能力以及远侧组件的构型是至关重要的，并且很大程度上决定导管的有用性。
导管的挠曲和转向通常由控制柄部实现，该控制柄部容纳挠曲机构，所述挠曲机构响应设置在控制柄部上的致动器。牵拉线沿着一侧在内腔中延伸穿过导管，并且挠曲机构向近侧拉动牵拉线，以使导管朝向该侧挠曲。双向挠曲由各自沿着导管一侧的两个相对的牵拉线实现。通过在一个所选方向或另一所选方向上操纵致动器，挠曲机构作用于所选的牵拉线上，以沿着导管的该侧使导管挠曲。每根牵拉线的远端通常通过锡焊至末端圆顶或T形棒的卷曲套图而锚定，所述末端圆顶或T形棒粘结至管的侧壁中的金刚石切削沟槽。然而，这些锚定装置可从内腔错开，因此使牵拉线经受弯曲和剪切的组合应力以及拉伸应力。此外，末端挠曲也可倾斜和离面，从而降低所需挠曲的可预测性。
导管的另一问题来自远侧组件的支撑构件与非导电覆盖件之间的空转和滑移，这降低了标测和消融过程的准确性。此外，当远侧组件经受反复和／或过度的接触力时，支撑构件也可能与导管分离或分开。另外，反复和／或过度的接触力也可损坏接近支撑构件锚定至导管之处的部件，如位置传感器。
因此，需要以避免牵拉线上的弯曲应力和剪切应力的方式来提供双向挠曲的一种导管，以及避免偏移或离面挠曲的一种导管。也需要一种在标测和消融过程中使支撑构件与覆盖件之间的微移动最小化的导管、以及一种具有可靠安装至所述导管的远侧组件的导管。
发明内容
本发明涉及一种导管，其具有安装于其远端的远侧组件。该远侧组件具有大致圆形的主要部分，该大致圆形的主要部分具有至少一个套环，否则具有两个套环，即外套环和内套环，所述两个套环中的每一个带有适于标测和／或消融的多个环形电极。该大致圆形的主要部分通常横向于所述导管的纵向轴线。该大致圆形的主要部分的套环可位于一个平面内，或者一个套环可比另一个套环位于更远侧，以形成盘旋或螺旋状图案。
在一个实施例中，该导管具有细长管状导管主体、可挠曲中间节段以及远侧组件，所述细长管状导管主体具有至少一个内腔，所述可挠曲中间节段具有至少两个偏轴内腔，且所述远侧组件具有管状结构，所述管状结构具有附接至所述可挠曲中间节段的大致直的近侧区域和大致横向于所述近侧区域并位于所述近侧区域远侧的大致圆形的主要区域。该远侧组件具有细长棒状支撑构件，所述细长棒状支撑构件具有延伸穿过所述远侧组件的长度的形状记忆。挤出的非导电覆盖件覆盖延伸穿过所述覆盖件的第一内腔的支撑构件。第一内腔的尺寸设定成提供与支撑构件的紧密或过盈配合，以最小化覆盖件与支撑构件之间的空转和微移动。用于承载在远侧组件上的电极的导线延伸穿过形成于所述覆盖件中的第二内腔。覆盖件由如下材料构造：所述材料易于适形于支撑构件的形状和构型而无需热处理。
在一个实施例中，单根连续牵拉线延伸穿过导管，以实现可挠曲节段的双向挠曲。所述可挠曲节段具有用于牵拉线的至少两个偏轴内腔，所述牵拉线预弯成具有中间部分和两个近端部分的U形。在可挠曲中间节段的远端处，中间部分跨越两个偏轴内腔，所述两个偏轴内腔中的每一个容纳朝向控制柄部延伸的近端部分。在所述中间部分与所述远端之间设置至少一个垫圈，以当牵拉线的近端部分被用以挠曲时克服压缩力来增强可挠曲节段的远端。所述垫圈具有至少两个孔，所述至少两个孔均与所述可挠曲节段的相应偏轴内腔对齐。每个孔相对于相应内腔居中，使得延伸穿过垫圈孔和偏轴内腔的牵拉线的每个近端部分与导管的纵向轴线大致平行，并因此经受仅具有最小剪切力的张力。有利的是，以此方式实现的双向挠曲为更可预见的在面内，且具有较小偏移。
在一个实施例中，远侧组件的支撑构件在其近端处锚定于连接器节段中，所述连接器节段在可挠曲中间节段与远侧组件之间延伸。所述连接器节段具有填充有粘合剂的中心内腔以形成粘合剂体积，所述支撑构件的近端锚定于所述粘合剂体积中。为此，使所述支撑构件的近端变平，以提供具有更粘结表面的更平面的形式。所述近端也呈锯齿状以提供不规则的粘结表面。因此，装入粘合剂中的近端抵抗旋转和轴向运动，否则所述旋转和轴向运动可使支撑构件和远侧组件从导管松开或分离。
在一个实施例中，牵拉线的每个近端部分由压缩线圈围绕，所述压缩线圈为柔性的但抵抗压缩。因此，压缩线圈的远端限定了当牵拉线受到控制柄部中的挠曲机构的作用时用于引发挠曲弯曲的位置。通过提供具有更长长度的第一压缩线圈和具有更短长度的第二压缩线圈，牵拉线的每个近端部分具有不同的挠曲引发位置，并因此具有不同的挠曲弯曲，以提供不对称的双向挠曲。
在一个实施例中，将位置传感器装入连接器节段的粘合剂体积中。传感器具有包封至少一个感应线圈的外壳。所述外壳通常被包封在保护管中，所述保护管将至少一个感应线圈与粘合剂体积隔离，并保护所述至少一个感应线圈使其免受可能损坏传感器的作用于粘合剂体积上的扭转力和／或轴向张力/压缩力。
附图说明
通过参考以下与附图结合考虑的详细说明，将更好地理解本发明的这些和其他特征以及优点，其中：
图1为根据一个实施例的本发明的导管的透视图。
图2为图1的导管的导管主体的透视图，其中去掉了外壁和加强件的部分。
图2A为沿着线A--A截取的图2的导管主体的端部横截面图。
图3为图1的导管的可挠曲中间节段、连接器节段和远侧组件的透视图。
图3A为沿着线A--A截取的图3的可挠曲中间节段的端部横截面图。
图3B为沿着线B--B截取的图3的连接器节段的端部横截面图。
图4为图3的可挠曲中间节段的多内腔管的透视图。
图5为图4的管的远端以及两个垫圈和牵拉线的分解透视图。
图6为图1的远侧组件、连接器节段和可挠曲中间节段的远端的透视图。
图6A为沿着线A--A截取的图6的远侧组件的端部横截面图。
图7为图1的远侧组件的端视图。
图8为根据另一实施例的远侧组件的端视图。
具体实施方式
如图1所示，本发明的导管10包括具有近端和远端的细长导管主体12、在所述导管主体的远端处的可挠曲远侧节段14、以及在导管主体的近端处的控制柄部16。导管也包括远侧组件17，所述远侧组件17在远侧节段14的远端处安装至连接器节段15。远侧组件承载适于标测和／或消融的多个电极27。
参照图2和2A，导管主体12包括具有单个轴向或中心内腔18的细长管状构造。导管主体12为柔性的，即可弯曲的，但沿其长度基本上不可压缩。导管主体12可具有任何合适的构造，并且可由任何合适的材料制成。在所公开的实施例中，所述导管主体包括至少外壁20(例如PEBAX或Pellethane的)。外壁20可包括不锈钢等的嵌入式编织网孔，以增加导管主体12的扭转刚度，当控制柄部16旋转时，导管主体12以相应的方式旋转。
导管主体12的外径并非关键，但可为约7或8弗伦奇(french)。同样，外壁20的厚度并非关键，但足够薄使得中心内腔18可容纳部件，所述部件包括牵拉线、多根导线、缆线和／或管材。如果需要，外壁20的内表面可衬有(例如聚酰亚胺的)加强管(未示出)，以当牵拉线张力使导管主体压缩时在导管挠曲的过程中提供改善的扭转稳定性，并提供轴波状的减少。
参照图3和3A，可挠曲远侧节段14包括管22的较短节段，其具有多个内腔，包括各自用于牵拉线的至少第一偏轴的直径相对的内腔30和第二偏轴的直径相对的内腔31。在所示实施例中，也存在至少第三偏轴内腔32和第四偏轴内腔33，所述内腔33用于缆线36，所述缆线连接至位置传感器34，且内腔32用于导线35，所述导线连接至远侧组件17上承载的或接近远侧组件17的电极27。在适当的时候可提供附加的内腔，例如用于冲洗管以将冲洗流体传输至远侧组件。管22由合适的无毒材料制成，所述材料优选地比导管主体12更具柔性。用于管22的一种合适的材料为编织聚氨酯，即具有嵌入的编织不锈钢等的网孔的聚氨酯。每个内腔的尺寸并非关键，但足以容纳相应部件，所述部件如导线、牵拉线、缆线和管材。
导管主体12的可用长度(即除了远侧组件17以外可插入体内的部分)可根据需要变化。在一个实施例中，可用长度在约110cm至约120cm的范围内。远侧节段14的长度为可用长度的相对较小部分，并且优选地在约3.5cm至约10cm的范围内，更优选地在约5cm至约6.5cm的范围内。
为了附接导管主体12和远侧节段14，远侧节段14的管22的近端包括更小的外圆周凹口26，如图4所示，所述更小的外圆周凹口26容纳导管主体12的外壁22的远端的内圆周表面。远侧节段14和导管主体12的重叠部分通过胶等附接。如果需要，可在导管主体内在加强管(如果提供)的远端与远侧节段的近端之间设置间隔件(未示出)。所述间隔件在导管主体和远侧节段的接合处提供柔性的过渡，这允许所述接合平滑地弯曲而不折叠或扭结。具有此类间隔件的导管在美国专利5,964,757中有所描述，该专利的公开内容以引用方式并入本文。
如图3所示，连接器节段15具有短的圆柱形构件或管23，所述短的圆柱形构件或管具有中心内腔19，所述中心内腔容纳位置传感器34并锚定远侧组件17的近端。管23可由任何合适的材料(例如PEEK)构造。为了附接远侧节段14和连接器节段15，可挠曲节段14的管22的远端包括更小的外圆周凹口28，如图4所示，所述更小的外圆周凹口28接收圆柱形构件23的近端的内圆周表面。管22和23的重叠端通过胶等附接。
为了实现沿着导管主体12的挠曲以操纵导管主体12和远侧组件17，牵拉线24从控制柄部16延伸，并延伸穿过整个导管主体12(图2)。根据本发明的特征，牵拉线为提供双向挠曲的单个连续拉伸构件，即，在远侧节段14的管22的第一内腔30和第二内腔31所限定的平面内在相对的方向上沿着导管的两侧挠曲，如图1所示。还如图5所示，牵拉线24具有延伸穿过内腔30的第一纵向近侧部分24A、延伸穿过内腔31的第二纵向近侧部分24B、和在具有约90度的角度的两个相对的弯曲或拐角之间形成的中间短的部分24M。纵向部分24A和24B与导管的纵向轴线平行，由于短的部分24M在管22的远端处跨越内腔30和31，因此其通常与导管的纵向轴线垂直。牵拉线24的两个近端均锚定在控制柄部16中，如本领域普通技术人员所理解。沿着导管的一侧在一个方向上的挠曲能够通过使用者操纵控制柄部16上的致动器54(图1)而实现，所述操纵向近侧拉动一个或另一个长的部分24A或24B。就此而言，每个长的部分由相应压缩线圈25A、25B(图2)围绕，所述压缩线圈25A、25B从导管主体12的近端延伸穿过中心内腔18进入远侧节段14的相应内腔30或31(图3A)，并沿着远侧节段14的管22的长度分别终止于预定的远侧位置A和B(图1)。牵拉线24由任何合适的金属如不锈钢或镍钛诺制成。牵拉线64的直径优选地在约0.006至约0.010英寸的范围内。
每个压缩线圈25A、25B由任何合适的金属制成，优选地为不锈钢。压缩线圈自身紧密缠绕以提供柔性(即弯曲)，但可抗压缩。压缩线圈的内径优选地稍大于牵拉线的直径。牵拉线24上的Teflon.RTM.涂层允许牵拉线在压缩线圈内自由滑动。每个压缩线圈25A和25B的外表面由柔性非导电护套29A和29B(图2)覆盖，所述柔性非导电护套29A和29B例如由聚酰亚胺管制成。
由于每个压缩线圈为柔性的但抗压缩，因此其远端充当用于引发相应牵拉线的挠曲的所需位置。用于引发每根牵拉线的位置可沿着导管的纵向轴线彼此相同，或者对于每根牵拉线或牵拉线部分(在本文可交换使用)而言所述位置可不同。在图1和2所示的实施例中，两个位置A和B通常位于可挠曲节段14的远端与近端之间，并且位置A比位置B位于更远侧，这产生了如下导管：所述导管相对于具有更短压缩线圈24A的纵向部分24B的一侧(其具有更大或更松挠曲DB)，所述导管在具有更长压缩线圈25A的纵向部分24A的一侧上具有更小或更紧的挠曲DA。如图1所示，挠曲DA具有限定半径的较小弯曲，挠曲DB具有限定半径的较大弯曲。
压缩线圈通过近侧胶接而在其近端处锚定至导管主体12的加强件21，并通过远侧胶接而在其相应的远端处锚定在内腔30和31中。两个胶接优选地包括聚氨酯胶等。可利用注射器等通过导管主体和可挠曲远侧部分14的管中所产生的孔来使用所述胶。此类孔可例如通过刺穿管壁的针头等形成，所述针头被充分加热以形成永久性孔。然后将胶通过所述孔引入到压缩线圈的外表面，并围绕外圆周芯吸，以围绕每个压缩线圈的整个圆周形成胶接。
作为本发明的另一特征，至少一根牵拉线应变消除压缩垫圈38设置于管22的近端，以锚定中间部分24M。如图5最佳所示，垫圈38形成为具有至少两个通孔40和41，所述至少两个通孔各自分别与远侧节段14的第一内腔30和第二内腔31的中心轴向地对齐。每个孔40和41的直径可比牵拉线的横径(cross-diameter)大至多约14％。在挠曲过程中，一个长牵拉线部分24A或24B处于张力下，并且由于容纳于控制柄部16中的挠曲机构所施加的牵拉线张力，因此垫圈38抵靠远侧部分14的管22的柔软弹性远端压缩。由于垫圈孔40和41与内腔30和31对齐，因此在每个纵向部分24A和24B上的力向量与内腔30和31直接对齐，且纵向部分24A和24B在挠曲过程中仅经受拉伸应力负载。该结构提供了更好的末端挠曲特性，并降低了与在前双向挠曲构型相关的倾斜和离面挠曲。垫圈38可由任何合适的材料包括不锈钢、镍钛诺或钛制成。
垫圈38可在其外圆周边缘具有突出部56。垫圈可由单个酸蚀片材大量制成，因此突出部56为用于在制造过程中固定垫圈的结构。
在图3和5所示的实施例中，第二牵拉线应变消除压缩垫圈39紧邻垫圈38并在垫圈38的远侧设置。垫圈38和39在结构和构型上通常彼此相同。可使用单个或任何多个垫圈来提供所需的最佳厚度，以在通过牵拉线挠曲的过程中最小化或防止管22的远侧末端的变形。
再次参照图5，单根连续牵拉线预弯成具有两个90度弯头，以形成部分24A、24B和24M。纵向部分24A和24B各自瞄准垫圈38和39的孔40和41以及管22的内腔30和31。两个90度弯头结合垫圈孔40和41相对于牵拉线的横截面或厚度之间的紧密度容限，将牵拉线相对于远侧节段14的管22锁定就位，并且当经由致动器和挠曲机构施加张力时，防止牵拉线在垫圈处的90度弯头处变形和滑动。
参照图3，在管22的远端上滑动的连接器节段15的管23的近端覆盖垫圈38和39，并通过柔性粘合剂(如两部分聚氨酯)粘结至管22的远侧凹口端28。连接器节段15的管23的中心内腔19由通过合适的粘合剂体积47(例如环氧树脂)装入其中的各种部件占据。在所示实施例中，装入的部件包括远侧组件17的支撑构件50的近端部分58、用于远侧组件17上的电极27的导线35的非导电过渡管44、和从传感器缆线36的远端延伸的位置传感器34。位置传感器34包括至少一个感应线圈和用于线圈的外壳(均未示出)。所述外壳继而有利地包封在热收缩覆盖件或管45(在3B中最佳看出)中，以分离线圈和粘合剂47。这样，由于传感器不直接粘结至粘合剂体积47，从作用于支撑构件50上的扭转力和／或轴向张力／压缩力传递至粘合剂体积47中的任何应力与传感器34分离。基于粘合剂的传感器外壳和粘合剂的膨胀系数无需匹配以防止传感器外壳的应力断裂。
连接至承载在导管10上的电极27的导线35穿过非导电管37，所述非导电管从控制柄部16经过导管主体12的中心内腔18，如图2和2A所示。然后导线35穿过可挠曲节段14的第三内腔32，并穿过在垫圈38和39中的每一个中形成的第三通孔43。然后导线37穿过例如由聚酰亚胺构造的非导电管44，所述非导电管延伸穿过连接器节段15。管44具有近端和远端，所述近端向连接器节段15的近端的近侧延伸短距离，并且所述远端通常与连接器节段15的远端相连。垫圈孔43与可挠曲远侧部分14的内腔33轴向对齐。
传感器缆线36从传感器34的近端延伸，并穿过在垫圈38和39中形成的第四偏轴通孔44、穿过可挠曲远侧部分15的第四内腔34、穿过导管主体12的中心内腔18并进入控制柄部16中。非导电管46围绕延伸穿过连接器节段15的传感器缆线的一部分。例如由聚酰亚胺构造的管46具有近端和远端，所述近端向连接器节段15的近端的近侧延伸短距离，所述远端邻接传感器34的近端。
如图3和6所示，远侧组件17包括管状结构，所述管状结构包括支撑构件50、非导电覆盖件52和多个环形电极27。在所公开的实施例中，远侧组件17包括从连接器节段15轴向延伸的大致直的近侧部分58、在部分58的远侧并从部分58延伸约90度的大致直的部分59、以及大致圆形的主要区域60。两个部分59和60均大致横向于部分58和连接器节段15。如图7更好看出，近侧区域58(由X表示)通常偏离大致圆形的主要区域60的中心。近侧区域58优选地具有在约3mm至约12mm的范围内、更优选地约3mm至约8mm、还更优选地约5mm的暴露长度(即不包含在连接器节段15内)，但可根据需要变化。
也如图7所示，大致圆形的主要区域60形成至少360度的完整圆，并且更优选地形成约720度的不止一个套环或圆，例如具有内套环61和外套环62的两个套环或圆，使得其具有例如盘旋或圆锥形状。大致圆形的主要区域60大致横向于导管主体12和可挠曲远侧部分14，并优选地与导管主体形成约80度至约100度的范围内、更优选约90度的角度。在所示实施例中，两个套环61和62通常位于公共平面内。然而，应当理解可设置套环61和62，使得一个套环比另一套环位于更远侧，使得远侧组件具有大致盘旋形式。大致圆形的主要区域59具有优选地在约10mm至约40mm、更优选地约10mm至约35mm、还更优选地约12mm至约25mm的范围内、甚至更优选地约20mm的外径。所暴露的远侧组件17(当平直展开时)从其近端到远侧末端的长度(包括区域58、59和60)为在约2.2-6.2″、更优选地约3.6-5.4″、还更优选地约4.2-4.9″的范围内。在一个可供选择的实施例中，远侧组件17还包括从大致圆形的主要区域60基本上切线延伸的大致直的远侧区域64，如图8所示。区域64可具有在约2.0mm至约18.0mm、更优选地约4.0mm至约10.0mm的范围内的长度。
如图3所示，支撑杆或构件50为细长的，并延伸穿过远侧组件17的至少整个长度以提供其形状和构型。支撑构件由具有形状记忆的材料制成，即，在施加力时可从其初始形状变直或变弯，并能够在移除所述力时基本返回至其初始形状)。用于支撑构件的合适的材料为镍／钛合金。此类合金通常包括约55％的镍和45％的钛，但也可包括约54％至约57％的镍，剩余为钛。合适的镍／钛合金为具有优异的形状记忆性以及延展性、强度、耐腐蚀性、电阻率和温度稳定性的镍钛诺。
支撑构件50具有位于远侧组件17近侧的近端70。所述近端容纳并锚定于连接器节段15的粘合剂体积中。根据本发明的另一特征，使支撑构件50的近端70的近侧部分变平并且呈具有不平表面的锯齿状，例如具有凸起和凹陷区域72的格纹或齿状表面(参见图9A和9B)，以提供用于粘结接合的不规则的更粘结表面，所述粘结接合与具有圆形横截面的牵拉线的扭转屈服强度相等或者比所述扭转屈服强度更强。在近端70处对横截面构型的改变(例如从圆形形式改变为更椭圆或矩形形式)以及对表面纹理的改变(例如从大致平滑的表面改变为粗糙或不平的表面)提供了对装入连接器节段15中的粘合剂体积47中的支撑构件50的近端70的张力拉出或旋转/自旋的优异抗性。
覆盖支撑构件50和远侧组件17的其他部件(包括用于环形电极27的导线35)的挤出的非导电覆盖件52可由任何合适的材料制成，并优选地由生物相容性挤出塑料(例如聚氨酯或PEBAX25-35D肖氏硬度)制成。根据本发明的另一特征，覆盖件52形成为具有至少两个内腔53和54，支撑构件50延伸穿过内腔53，且导线35延伸穿过内腔54。用于支撑构件50的内腔53可偏轴，并在大致圆形的区域60的内圆周的侧面上，使得所述支撑构件可更好地支撑区域60的弯曲。内腔53及其直径的尺寸也特别设定成用于围绕支撑构件50进行紧密或摩擦配合，以在标测或消融过程中最小化或防止支撑构件50与覆盖件52之间的空转和微移动。覆盖件52的塑性材料有利地适形于支撑构件50的形状而无需热处理。其在导线35与支撑构件50之间提供机械阻隔和电隔离。覆盖件52从远侧组件17的远侧末端延伸至接近连接器节段15的远端，所述连接器节段的远端由圆顶74密封，所述圆顶74由合适的生物相容性材料如聚氨酯构造。远侧组件17的远侧末端由第二圆顶80密封，以形成用于远侧组件的无创伤末端，所述第二圆顶由合适的生物相容性材料如聚氨酯构造。支撑构件的远端由例如由聚酰亚胺构造的短管82围绕，以接合并锚定圆顶80。形成圆顶80的材料可向下注入至管82的内腔中并至管82的后方，以防止圆顶80分离。
远侧组件17在覆盖件52上承载有一系列电极27，包括环形电极。环形电极可彼此等距设置，或以紧密间隔的对设置。如本文所用，术语“环形电极对”指一对环形电极，相较于它们与其他相邻的环形电极的距离，它们彼此更紧密设置。优选地，一个电极对的两个电极27之间的距离小于约3mm，更优选地小于约2mm，还更优选地在约0.5mm至约1.5mm的范围内。电极的数量可根据需要而变化，并优选地在约12至28个环形电极的范围内，更优选地为约20个环形电极。
在一个实施例中，除了具有更大宽度的最远侧环形电极之外，每个电极的宽度通常相同。当在荧光镜透视检查下观察导管时，更宽的环形电极为使用者提供远侧末端的位置的视觉信号。具体地，由于标测组件通常为圆形，因此使用者可能难以确定哪些电极位于心脏中的特定位置处。通过将一个环形电极如最远侧环形电极的尺寸设定成不同于其他环形电极，当使用者在荧光镜透视检查下观察导管时具有参考点。
无论环形电极的尺寸和数量如何，电极对优选地围绕大致圆形的主要区域60大概均匀地间隔。紧密间隔的电极对允许更准确地检测相对于远场心房信号的近场肺静脉电势，这在试图治疗心房纤颤时是非常重要的。具体地，近场肺静脉电势为极小的信号，而位置极接近肺静脉的心房提供大得多的信号。因此，即使当远侧组件设置于肺静脉中以用于标测时，医师可能难以确定信号是小的近电势(来自肺静脉)还是较大的较远电势(来自心房)。紧密间隔的双极允许医师更准确地确定他正看着近信号还是正看着远信号。因此，通过具有紧密间隔的电极，能够精确瞄准具有肺静脉电势的心肌组织的位置，因此允许临床医生将治疗递送至特定组织。此外，紧密间隔的电极允许医师通过电信号确定心门的精确解剖位置。然而，应当理解环形电极可构造为以单极性或双极性能力(capacity)起作用。
将多个环形电极例如约2至26个，更优选地约20个安装于消融组件17的大致圆形的主要区域60的非导电覆盖件52上。此类环形电极例如对于标测和／或消融可为理想的。包括此类环形电极的导管的描述在名称为“Catheter Having Mapping Assembly”的美国专利申请序列号09／551,467中有所描述，所述专利申请的全部公开内容以引用方式并入本文。如果需要，另外的环形电极(未示出)可沿着远侧组件17和／或近侧部分14安装于别处。在图6所示的实施例中，环形电极27A在连接器节段15的远端处或接近连接器节段15的远端安装，环形电极27B在连接器节段的近端处或接近连接器节段的近端安装。
导线与环形电极的连接优选地通过如下方式实现：首先通过其上安装有环形电极的管的壁而形成孔。然后将导线拉引穿过所述孔。然后剥去导线端部的任何涂层，并将导线端部锡焊或焊接至环形电极的下侧，然后将环形电极滑动到孔上方的位置，并用聚氨酯胶等将环形电极固定就位。因此，对于远侧组件17上承载的每个环形电极27，使相应的孔85(参见图6A)穿过覆盖件52的壁，所述孔85与内腔54连通，相应的导线35延伸穿过所述内腔。对于在远侧组件17的近侧承载的环形电极27A和27B，其导线40在传感器缆线36的旁边延伸穿过内腔33。对于环形电极27B，使孔87(未示出)穿过管23的壁，所述孔87与连接器节段15的中心内腔19连通，相应的导线延伸穿过所述中心内腔。对于环形电极27A，使孔84(图3A)穿过可挠曲节段14的管22的壁，所述孔84与内腔32连通，相应的导线延伸穿过所述内腔。每个电极导线35的近端在控制柄部16的近端处连接至合适的连接器(未示出)。连接器连接至合适的消融能量(例如射频(RF)能量)源(未示出)。
在使用中，将合适的导引护套插入患者中，将所述导引护套的远端设置于用于标测和／或消融的所需位置处。可与本发明一起使用的合适的导引护套的例子为Preface.TM编织导引护套(PREFACE.TM.Braided GuidingSheath)，其可从Biosense Webster，Inc.(Diamond Bar，Calif.)商购获得。将护套的远端引导至所关注的区域中，例如患者心脏的心房中的一个。将根据本发明的导管经导引护套送入，直至其远端从导引护套的远端延伸出来。当导管馈送穿过导引护套时，远端组件17被伸直以适于穿过该护套。一旦导管的远端定位在所需位置处时，将导引护套向近侧拉动，使得可挠曲远侧部分14和远侧组件17延伸到所述护套的外部，并且远侧组件17返回至其初始形状。然后将远侧组件17插入肺静脉或其他管状区域(如冠状窦、上腔静脉或下腔静脉)，使得组件17的大致圆形的主要区域60的每个套环的外圆周与管状区域内部的相应圆周接触。
远侧组件17的圆形构造提供了用于将环形电极27保持在管状区域的所需位置中的稳定机构。使用者可通过旋转控制柄部16而旋转远侧组件17，以将电极移动至沿着各自的圆周与相邻的点接触。远侧组件的设计允许使用者能够更容易地沿着管状区域的不同圆周使环形电极与组织同时接触，特别是当管状区域的直径或尺寸随距离而减小时。本发明的导管具有双重用途设计。可使用与心脏壁接触的远侧组件的套环中的大多数而快速标测(高密度标测)心脏壁的大的区域。如果将外径的尺寸准确地设定成用于患者的解剖，则导管也可用于标测每个套环的外圆周与动脉壁接触之处的肺动脉。
如本领域技术人员将了解，更易于在一定方向上转动远侧组件，从而牵拉而非推动末端。例如，在本文所示的实施例中，当组件17在逆时针方向上形成时(当从控制柄部16的远侧观察时)，优选在顺时针方向上转动组件。因此，如果需要，箭头或其他指示器(未示出)可包括在柄部或导管主体的近端上，以指示使用者在患者体内旋转组件17的优选方向。
具有双向挠曲的导管的合适的设计(包括用于这些实施例的合适的控制柄部)描述于例如美国专利6，123，699、6，171，277、6，183，435、6，183，463、6，198，974、6，210，407和6，267，746中，所述专利的全部公开内容以引用方式并入本文。
或者，可包括第二牵拉线(未示出)以改变或紧缩远侧组件17的大致圆形的区域60的直径或尺寸。这种设置通常描述于美国专利5，626，136中，所述专利的公开内容以引用方式并入本文。上述控制柄部可用于操纵第二牵拉线。
已结合本发明的当前优选实施例进行了以上描述。本发明所属技术领域内的技术人员将会知道，在不有意背离本发明的原则、精神和范围的前提下，可对所述结构作出更改和修改。应当理解，附图未必按比例绘制，并且除了任何其他实施例的任何其他特征之外或者取代任何其他实施例的任何其他特征，可引入任何实施例的任何特征。
因此，以上描述不应视为仅与附图所述和所示的精确结构有关，而应视为符合包括其最完全且最合理范围的下列权利要求书，并作为下列权利要求书的支持。

Claims (19)

1.一种导管，其包括：
细长管状导管主体，所述细长管状导管主体具有延伸穿过其的至少一个内腔；
可挠曲中间节段，所述可挠曲中间节段具有近端和远端以及延伸穿过其的至少两个偏轴内腔，所述可挠曲中间节段的近端附接至所述导管主体的远端；以及
位于所述可挠曲中间节段远侧的远侧组件，所述远侧组件包括：
管状结构，所述管状结构具有附接至所述中间节段的大致直的近侧区域、通常横向于所述近侧区域并位于所述近侧区域远侧的大致圆形的主要区域；
延伸穿过所述远侧组件的细长支撑构件，所述细长支撑构件具有形状记忆；
非导电覆盖件，所述非导电覆盖件在所述远侧组件的至少主要区域之上；以及
至少一个电极，所述至少一个电极承载在所述远侧组件的大致圆形的主要区域上；
在所述可挠曲中间节段的远端处的至少一个垫圈，所述垫圈具有至少两个偏轴内腔，所述至少两个偏轴内腔均与所述可挠曲中间节段的相应偏轴内腔轴向对齐；
牵拉线，所述牵拉线具有两个近侧部分和横向于所述两个近侧部分的中间部分，每个远侧部分延伸穿过所述可挠曲中间节段的相应偏轴内腔和所述垫圈的相应偏轴内腔，所述中间部分位于所述垫圈的远侧，并且在所述垫圈的两个偏轴内腔之间延伸；以及
控制柄部，所述控制柄部包括挠曲机构，所述挠曲机构适于作用于锚定在所述控制柄部中的所述牵拉线的至少一个近侧部分上，以使所述可挠曲中间节段挠曲。
2.根据权利要求1所述的导管，其特征在于，还包括所述远侧组件与所述可挠曲中间节段之间的连接器节段。
3.根据权利要求2所述的导管，其特征在于，所述支撑构件的近端容纳于所述连接器节段中。
4.根据权利要求1所述的导管，其特征在于，所述支撑构件的近端变平。
5.根据权利要求1所述的导管，其特征在于，所述支撑构件的近端具有不平表面。
6.根据权利要求1所述的导管，其特征在于，还包括围绕所述两个近侧牵拉线部分中的一个的第一压缩线圈和围绕所述两个近侧牵拉线部分中的另一个的第二压缩线圈。
7.根据权利要求6所述的导管，其特征在于，所述第一压缩线圈具有第一远端，并且所述第二压缩线圈具有第二远端，并且所述第一远端位于所述第二远端的远侧。
8.根据权利要求2所述的导管，其特征在于，所述连接器节段的内部填充有粘结材料。
9.根据权利要求8所述的导管，其特征在于，所述支撑构件的近端装入所述粘结材料中。
10.根据权利要求8所述的导管，其特征在于，还包括装入所述粘结材料中的位置传感器。
11.根据权利要求10所述的导管，其特征在于，所述位置传感器被围绕于热收缩管中。
12.根据权利要求1所述的导管，其特征在于，所述支撑构件和覆盖所述支撑构件的所述非导电覆盖件具有摩擦配合。
13.根据权利要求1所述的导管，其特征在于，所述非导电覆盖件具有至少两个内腔，所述支撑构件延伸穿过所述两个内腔中的一个。
14.根据权利要求1所述的导管，其特征在于，所述垫圈的两个偏轴内腔中的每一个与所述可挠曲节段的相应偏轴内腔的中心轴向地对齐。
15.根据权利要求1所述的导管，其特征在于，所述大致圆形的主要区域具有至少两个套环。
16.根据权利要求1所述的导管，其特征在于，所述多个电极在约2至24之间的范围内。
17.根据权利要求1所述的导管，其特征在于，所述多个电极为约20。
18.根据权利要求1所述的导管，其特征在于，还包括承载在所述可挠曲节段上的至少一个电极。
19.根据权利要求1所述的导管，其特征在于，还包括位于所述远侧组件近侧的至少一个电极。
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