CN1093933A - 导管变位控制 - Google Patents
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Abstract
一种用于脉管的手术导管,带有远侧工作端头,
配装着精确的形状控制装置。端头部分包括许多削
弱区段。一些可往复操作的控制拉线从正好越过各
个变位区段的地方向导管远侧段施加纵向张力,促进
各个变位区段在各个削弱或切口区域的方向上发生
弯曲或屈曲。另外,一种可往复调节的变位形状控制
元件在导管工作段的主内管腔里面往复滑动,并且可
以相对于导管工作段沿轴向加以调节,以便精确地变
换由名条控制拉线在导管段上面所造成的变位特
性。
Description
本发明是1992年11月16日提出的申请号为07/976,784的部分继续申请。进一步参照1992年7月7日提出的申请号为07/909,867的专利申请,它是1992年2月14日提出的申请号为07/835,553的正在处理的申请的部分继续申请。进一步参照1992年7月7日提出的申请号为07/909,869的申请,它是1992年2月24日提出的申请号为07/840,162的正在处理的申请的部分继续申请;并参照1992年2月24日提出的申请号为07/840,026的申请。这些相互参照的申请与本发明享有共同的发明权,全都涉及经过改进的、具有受到控制的挠性远侧端头的一类血脉导管。
本发明的目的一般地在于对具有广泛用途的血脉导管从机械角度从事改进。本发明可用于心病学家用来作末梢或冠状导管插入手术或气胀血管成形手术的一类导管,包括电生理学家用于施行心脏的电扫描显示或电组织烧除的导管,还包括放射学家用在大脑或者任何动脉造影/静脉造影手术操作中的、或者空腔造影或手术中的各种器械。特别是,本发明赋予这种导管以多方向锐角变位功能,使之能够进出并处理诸如分支脉管或者类似的难以抵达的部位。在这某些情况下,本发明可以免除导引线的需要,而且为实施诸如电扫描显示以鉴别心脏心律不齐病源的手术操作所需要的时间可以大大缩短,并且由于本导管的操作灵活性得到提高,手术的实施也会更为成功。
发现心脏心律不齐病源的电扫描显示以及随后的排除这种来源的电组织烧除代表着本发明的改进型导管的一项重要应用。此外,心室、心瓣和相关脉管对于为从事扫描显示和烧除而需要的穿行操纵并抵达远处部位的复杂性代表着一种实实在在的挑战。
在健康的心脏中,通常的心脏博动是由称作窦房结(SA结)的专门结构控制的。这是心脏的天然起博器,是位于右心房肌壁中的特定组织。SA结提供博动以支配心房和心室的固有或天然的节奏性收缩。这种支配或控制包括传送离子脉冲通过心房和心室的心脏传导通道,这些脉冲使心脏以受SA结支配的速率有规律地按顺序收缩和放松。这种顺序确保在每次心室收缩时供给系统循环或肺脏系统的血流为最大。SA结具有自己固有的、能够由出自神经系统的讯号予以改变的速率。在对激动。体力活动等作出反应时,交感和副交感神经就起作用以改变这一速率。
SA结一开始发出非极化脉冲,象电波一样传播,从其右心房中的位置跨向左心房,再向下到心房和心室中间的过渡区,在该处有另一个结,称作房室结(A-V结)或接点。这种脉冲以较慢的方式传过A-V结并继续前行到右和左心室之间的称作希斯束的一条共同通道,然后进入叫做右和左希斯束支的多条通路之中,每一希斯束支供应一间心室。这些希斯束支往后分解成一个具有传导组织的细小通路所构成的巨大网络,从心脏的内表面向外表面扩展,称作浦肯野纤维。这些纤维把非极化脉冲送入心室心肌的所有部分。
只要这一系统未受损伤,脉冲就会正常传递,心脏节律得以维持。不过,心脏传导系统中的天然脉冲或电流会因导致形成结痂组织的先天缺陷、疾患或损伤而受到阻断或变更。当心脏传导通道或心室心肌中存在十分严重的创伤或先天缺陷时,电脉冲就不会正常传递,就会出现称作心律不齐的节律失调。关于这类失调,心博徐缓一词用来描述心脏收缩的不正常放慢,而心博过速一词用来描述异常迅速的心脏跳动。虽然这些情况中的任一种就会危及患者的生命,但心博过速则更为严重,特别是在患者具有潜在的心脏疾病时是如此。
心到性心博过速和其他的心室性心律不齐一直是用许多诸如利多卡因、奎尼丁和普鲁卡因酰胺等药物加以治疗的。在交感视经活动过度或肾上腺分泌过度的情况下,一直使用β抑制药物。在防止过速性心律不变方面药物疗法无效的情况下,一直使用某些外科手术从或者心房或者心室切除致心律不齐的组织。这种手术包括大型外科术,其中要穿心前区和心脏肌肉以查找导致心律不齐的组织,随后加以冻结或用外科办法摘除,以便代之以结痂组织。
由于开心外科术是一种具有高度风险的手术,需要长期住院和恢复,因而需要一种较少外伤的解决办法。随之而来的是,各种各样类型的手术导管被发明出来,并用来诊断和治疗许多心脏异常疾患以避免开心外科术造成外伤。例如,作为解决动脉粥样硬化性斑块集结的一种方法,使用气胀血管成形术目前要例行地打开狭窄损伤部位。在这种手术中,一只携带着导管的气囊被导引通过病人的脉管系统,达到狭窄位置。气囊电通过导管管腔注入流体鼓胀后向被阻塞的脉管加压,从而把它撑开。血管成形导管插入术可能需要精巧而又复杂的脉管巡航,其中锐角导管肯定会是很有利的。
导管器械也一直用来查寻并切除心脏传导通道。美国专利4785815中说明了一种这样的器械,其中导管管筒在其远侧端部插带至少一个电极用于检测心脏内部的表膜电势,还连同一个加热装置用以靠热力办法切除由检测装置查寻到的至少一部分通道、另一种用于微观横断或宏观横断心脏内部传导通道的热切除导管在其远侧端部采用电阻加热元件用来从事极为局部化的治疗,在美国专利4869248中有图例说明。这些器械在切除元件一旦正确地被定位在所关注的局部部位时一般都是很有效的。上述这类导管器械的端头也一直有所发展,此端头采用了一种单一手柄操作式变位拉线控制装置。美国专利4960134中披露了这样一种器械。专利4911148披露了一种器械,其中一组对齐排列的、间隔开的切口配置在一部光学内诊镜的多管腔塑料管的远侧段,并连同一根张紧拉线以便使内诊镜的远侧端部便于产生单向变位。不过,这种器械也只是限于单向变位。
电生理导管切除手术操作,比如说,往往因手术人无法操纵导管端头抵达致心律不齐组织的精确位置而受到阻碍。这主要是导管管筒本身有限的可操纵性所造成的结果。导管管筒必须具有充分的强度和刚度,被导引通过脉管系统抵达所关注的组织近旁。上述结构无法使导管端头的挠曲达到所需程度以便在有关的极为局部化的部位实现多向操作。现有的各种导管,即使是带有单一变位拉线控制器的那些导管,其特点在于不能适当控制微细运动,并具有只能在平行于主导管管筒的那些平面内产生变位的端头。它们缺乏使在心房或心室内部其他方向上的侧向运动得到控制的能力。
大多数已有的心脏组织切除手术操作都包括使用经电导管传向该组织的无线电频率(RF)电流,导管尽可能地置放在靠近心房或心室内部致心律不齐地点。为了病人的心律不齐症得以治好,不得不在心律不齐症源生的部位造成损伤。提高这类器械的操纵灵活性可能使切除前导管的精确定位达到最佳地步。
操纵极为灵活的、可多向变位的器械的其他应用场合是很多的。它们包括末梢或冠状导管插入术或者气胀血管成形术以及血管造影术等应用场合。
本发明提供一种新型设计,赋予导管端头以大为增强了的多向锐角可挠性。这样,通过提供经过加强的在复杂情况下从事精细操纵的可能性就给予导管一定量的“微调”功能,使导管能用于难以达到的分支脉管,从事远处器官表面的扫描显示;或者使得便于进入心脏中某些腔室表面或阀瓣表面部位。这一点可以借助于配备几种独特的导管/鞘套结构中的任何一种来实现,这种结构在相关的控制拉线发出命令式运作时能使配置在同一或不同方向上的一个或多个沿纵向间隔开的或毗邻的管筒变位区段产生独立的主要变位。
按照本发明的一项实施例,各自具有许多对齐排列的、沿纵向间隔开的、基本上平行的横向削弱部位的两个或多个沿径向并沿纵向间隔开的变位区段加以设置,以便一当来自远离这组削弱部位或有待变位的某处的纵向收缩力施加时在削弱部位的方向上易于变位或屈曲。形式为正好在每一复位区段以上(或至少)在最远的变位区段以上固定于导管管壁中的几条张紧式往复控制拉线的一些独立张紧装置控制着变位。导管或鞘套的纵向轴线事先安排好对在往复式控制拉线中施加张力作出反应而在每一变位区段的凹槽方向上向侧面弯曲或屈曲。
变位区段中的削弱部位可以采取任何方便的形状,不过在详细叙述中一般是以导管管壁上凹槽或切口的形式作图说明的,这些切口沿鞘套或导管外壳的一侧间隔开来并沿侧向或沿横向延伸大约四分之一到二分之一的鞘套或导管周长,对齐排列,一定变位区段的各削弱部位最好具有同样的径向配置。拉线可以在导管内部作沿纵向的双向或往复移动,并使远端固定在导管管壁上同每组凹槽对中并正好在凹槽上方的地方。
可以按照所需要的多向变位形状中想要作的变动,以同样的或不同的径向包角和轴向距离配置一些各自包含一组对齐排列的凹槽或削弱部位的其他变位区段。变位是由最好是固定在正好在每一变位区段上方的往复拉线来控制的,在该拉线的张力控制下促使管筒在凹槽的方向上弯曲。当然,在较远处固定的拉线将造成拉线固定点近侧的所有变位区段的变位。各部分的相对刚度最好是使得拉线的重新伸展将减小变位或使导管伸直。按照所需要的导管端头的适当变位或形状调节许多拉线或一根远处拉线中的张力可以取得极为良好的挠性和精细的方向控制。这就有可能在此前未能提供的多向挠性的高度上使复杂操作中的扭曲得到控制。
导管管壁或鞘套也可以带有一个或多个沿远侧部分的长度间隔开的、具有某一薄弱方向的非对称的管壁区段。拉线固定在正好是薄弱区段的上方。薄弱区段几乎象凹槽那样起着变位区段的作用。
在一项实施方案中,主导管中的一个或多个变位区段同可沿纵向移动的、可调节的内或外导管或鞘套装置相结合,这种装置可以越出或在可变位的导管或鞘套的主管腔之内滑动。以便通过限制削弱部位的变位而增大刚性,因而在相对于变位区段作往复调节之后进一步配合了并进一步改进了该器械远侧段的变位效果。
在另一项实施方案中,装有能够在主导管管腔中从事得到控制的往复运动的定位导引内导管,其本身具有沿纵向间隔开的削弱部位。可能是许多加长的切口部分。这些切口部分使得变位导引内管筒在那些限定的部位上同外导管一起挠曲。变位控制拉线连接在变位区段的上方的外导管上面。于是,外导管的变位就由内导管切口沿纵向的相对放置而受到控制。
在又一项实施方案中,代替变位导引内导管,装有其挠性经过调配的一根沿轴向可调节的挠曲控制细轴,以控制主导管变位的各挠曲点。这种细轴可以具有弹性构件的形式,比如一根线状构件,弯曲抗力或直径可以是沿长度一定的或变化的,在某一或某些部位易于变位,并在弯折力解除之后能弹回来。直径或弯曲抗力的变化可以是无定向的,或者使得在变位方面具有特定方向。变位细轴或线状构件可以置放在导管内腔之中。
为提供增强的挠性而在鞘套或导管上做出的切口可用比如聚氨脂。屏蔽材料制成的聚合物薄网层复盖住,以便在作为鞘套使用的情况下维护导管管腔的完善状况,并在作为烧除器械使用的情况下保护导管本身的外表面。对于具有削弱部位或者带加强筋的增强部位的、用挤压成形法制造的导管,这种复盖是不需要的。上述镶衬材料是很薄的、不渗透液体的、很柔软的和相当结实的,允许管筒无阻碍地随意挠曲。按照所设想的特定实施方案和应用场合以及各种需求,这种装置的变位能力方面的详细特性可以具体地加以确定。
在一项成功的实施例中,在工作导管管筒中正好靠近其远侧端头的距离处配置两组或多组在径向错开的、对齐排列的、沿纵向间隔开的横向凹槽。所配备的往复拉线的远侧端头固接在正好处于每组凹槽上方的导管侧壁上面。拉线穿过导管或鞘套壁上的沟渠,在连向控制手柄的一侧从管筒中出来。每条拉线都固定在滑动式控制拨钮的小轴上面。拨钮也配有由弹簧加偏压的闩锁机构,其中压下拨钮就会使它沿着一条带有一组分间隔做出的强制性止动孔位的槽道中移动,拨钮的下部小轴带有相匹配的形状,在拨钮上的压力解除之后,就可由返位弹簧操纵把拨钮的下部小轴纳入上述孔位。
还设想了其他几种变位和张力控制机构,包括采用带有滑动式旋钮的控制手柄,可以比如靠固定螺丝就地紧住。也设想了一些可以转动并按照卷筒方式缠绕或松开拉线的轴件。
附图中始终如一地用同样的标号标示同样的部分:
图1A是符合本发明的一种可多向变位的导管装置的放大断开透视图,有些部分截掉了;
图1B是表明图1A中导管双向变位的片断视图;
图2A是未变位状态下图1A中导管远侧段的大为放大的剖面视图;
图2B是图2A中实施例的备用方案的横断剖面图;
图3A和3B是同图1A中导管一起使用的控制手柄的放大视图;
图4A和4B描绘了在锁定和非锁定位置上可调节的拉线控制拨钮或手柄的放大了的片断细部;
图5A和5B描绘了用于鞘套式导管的备用手柄;
图6A-6D是描绘一种备用的拉线控制实施方案的放大了的片断细部;
图7A是示于图3A和3B的那些手柄的备用者的断开透视图;
图7B是用于变位导管的另一备用手柄的断开平面视图;
图8描绘了具有变位导引内导管管筒的变位导管的、断开的远侧片断侧视图,部分是剖视图;
图9A-9C是图8中导管的变位模式的简略示意图;
图10描绘了同图8中导管一起使用的一种手柄;
图11A-11C是显示可同任何导管一起使用的备用切口或凹槽形状的片断视图;
图12是采用变直径变位导引构件的类似于图8的视图;
图13是用于本发明的导管管筒的片断示意图,表明非对称的一段筒壁。
本发明的一个最重要方面是给予一类导管装置的远侧段以加强了的单或多向挠曲性,这类装置用于需要不断前行的远侧端头的复杂操纵得到控制、需要由远侧端头描述曲曲弯弯的路径的那些手术操作。应用场合包括使用导管电扫描显示或电切除器官组织中的难以达到的部位和查找难以进入的脉管狭窄处所。本发明的导管可以采取几种形式或实施方案中的任何一种,无论那一种对于某种特定的应用场合或手术操作都是最佳的。各幅附图表明了本发明的种种原理,但决不是用来限制或杜绝所设想的各种实施方案。
图1A描绘出一类手术导管中的具代表性的一具,此类导管特别适合于扫描显示细胞组织的放电强度和对细胞组织作精确的热切除。此导管具有整体地示于10处的柄部、相对刚硬的中间管段12和可灵活操纵的挠性远侧端部14。中段12在图上是断开的,表示导管的细长主体,它导引整个器械通过从插入点到接近于端部14予定抵达部位的那一点的血管系统。
烧除器械的柄部还包括示于16处的塞孔式插接电器,可外接多条输入/输出导线,并可连接任何其他类型的与导管操作有关的输入/输出装置。在本技术领域中这些都是为人所熟知的;在本申请中未加充分提供的那些细节,可以参考比如说前面提到的任何一次有审查中的申请中的资料,可以认为各个细节都在其中得到了具体体现。
变位控制装置位于柄部10的中央,包括一对沿纵向可调节的张力控制拨钮或滚卷旋钮,示于10和12,它们分别连接一对张紧的拉线24和26。拉线本身自控制总成向外延伸,穿过中间管段12的主管腔28和远侧管段14的主管腔30,随后固接在导管的内壁上56和58处(图2A和2B)。张力控制装置的握柄10的顶面外壳18进一步包括一对槽沟,各自代表一系列沿纵向间隔开的成形开孔,可能是如36和38处所示的矩形,由一些短小的一段段如40和42处所示的小沟分隔开来。
导管远侧挠性段14本身可以按照已知的导管技术实践加以制作,因而一般可能包括一段长度为3至30cm的、化学性能良好的挠性增强聚合管;取决于应用场合,外径为4F或更大、在电扫描/切除器械的情况下,配有带顶端电极44的、装设电极的白金制导管顶端装置,还配有一只或多只平行间隔开的辅助环状电极,如46处所示。顶端电极44和环状电极46借助于48处所示的一束电导线同导管外面的输入/输出装置在电气方面连接起来。
图中在紧靠榻极46处画出一对端部或远侧变位区段,每一区段包括平行间隔开的一组5个侧面切口,呈对齐排列的分散凹槽50和52形态,凹槽的长度或形状可以是任意的,比如形状为三角形或梯形,不过一般是在导管管筒14的360°周边上占据相对于经角为大约90至180度的一段长度(图1B),形状为梯形,表现为导管管筒14上的一些切口或凹槽。设在远侧一组切口50附近的第二组切口52,可以从切口50转过一定角度而处在不同的径向方向,并在导管部分14的挠性端头上构成一个近侧变位区段。
图示的组合(图1B)可提供双向变位。切口50或52可以是凹槽形式,具有所希望的任何宽度或形状以及深度(或包角)。在变位区段内的这些开口的数量或以按照导管结构的材料、装置的用途和挠性需求而加以改变。其他的一些形状示于图11A-11C,其中画出远侧导管片断114以表明在116和118处带有三角形切口而在120处带有梯形切口的变位区段,蒙皮或外层护膜122复盖着这些开口。当然,在器械中可以采用具有更加不同或者甚至全同的角度配置的其他一些变位区段,数量和配置方式与所需要的应用场合有关。
导管挠性端部14的一部分示于放大的剖面视图2A之中。控制拉线24和26分别靠T形构件56和58永久性地固接在导管区段14的内壁54上面。每一条控制拉线都固接在稍稍远离各自变位区段的地方,最好是在凹槽的中部。还要装设一层不渗透液体、有弹性和相当结实的外围薄膜或镶衬材料60,它允许导管管筒14随同变位区段利用图示凹槽发生挠曲,却能够相对于外界环境保持内腔30的完全液密性。此薄膜复盖着导管远侧部分14的所有变位区段。
按照本发明,所达到的变位或扭曲程度可以变化很大。这一点部分地取决于构成一定变位区段的一组切口的数量、尺寸、方向、形状和间距。考虑的问题包括:对齐排列的各切口做成多么宽,即开槽量多大,以及不同区段或切口组群的数量和角度关系。变位区段之间的距离,由对齐排列的切口组群之间的距离确定,也影响变位特性。这一现象还可能以如下方式加以控制:采用辅助的或变位控制封套,或者随着管筒历经多组变位区段,使近侧筒段比起远侧管筒来挠性稍微小一些。
本发明的一个重要方面涉及导管远侧挠性端部的多向变位的控制问题。因此,图2B描述绘了进一步配置了挠曲调整附加装置的图2A实施例,此装置的形态是一根可往复滑动地安装在导管14里面的导管内筒62。随着导管内筒62前行达到和越过一个或多个开口或切口52和50,它就协同导管14改变了挠性端部的局部变位或挠曲特性。构件62最好是刚硬的,至少要比开槽的外导管14难于弯曲。不过,同导管14的情况一样,构件62可以被赋予某种所需的刚硬程度或肖氏硬度,而与拉线24和26的张紧共同协调(下面要详细说明)以便形成更为精确的挠曲控制。虽然最好是把构件62置放在工作导管端部14的主腔之内,外层滑套也是可以应用的。
图3A表明柄部张力调节机构,显示出连接于控制拉线的每一拨钮或手柄的许多位置,拉线的纵向张力是有待调节的。手柄装置之一22在一处是画得叠置在其他物体上的,而在另一处是虚拟的,其独自的柄茎或柄轴64处在邻近两个止动孔口36的中间位置。一种可供代换的实施例示于图3B,其中旋钮66和68沿纵向对中在单一的槽道或者柄部10的进一步包含止动孔口72和中间位置74的同轴式变体70之中。当然,图示的手柄只不过是多种类似的而且在机械方面等同的形式中的某一种,可以用来调节拉线中的张力并在随后维持已调节好的张力。
图5A和5B是把图1A的柄部作为带有密封入口的鞘套连接装置而不是切除装置而加以说明的。柄部80包括同样的挠曲控制,并具有密封入口接头82,还带有连接多位阀门或塞栓86的侧管84。另一密封通道示于85,而可供代换的一种通道示于图5B的87处。此装置包括一条或多条空腔,以88处(图1B)所示的熟知方式伸向挠性端部14。从机械角度看,如20、22、66或68等处所示的拨钮或滚卷旋钮可以采取本技术领域中的熟练人员或许会想到的几种形式中的任何一种。这些形式包括图示于图4A-4C的片断放大细部中的处于锁定和非锁定位置上的弹簧加载型和图示于图6A-6D中的可供代换的螺纹或实施例。图示于图4、5A和5B中的实施例表示图1和3A中10处和图3B中70处的两种操作柄部中的任何一种。顶部的断续通路40和42分别图示在图4和5A的锁定和非锁定位置上。图4中,显示出了柄部顶盖18,此顶盖的一段实际上就表明了止动孔口和通路40和42。操作旋钮22用一段较细的茎杆64连接起来,茎杆本身又连接在较大直径的空心套杆65上面。往下是中等粗细的杆段67,上面绕着一根压缩弹簧90,弹簧两侧是间隔开的弹簧挡板92和94。杆段67设计得可以响应拨钮20上面的压力或者弹簧90的伸展而在空心套杆65里面上下移动。旋钮轴杆的最后一段84可滑动地装入底盖98中的下部连续凹槽之中。
图6A-6D表明另一种用于张紧拉线的旋钮控制器的备用实施方案,包括拨钮或手动滚卷旋钮100,固接在茎杆102上,而茎杆又固接在带螺纹构件104上,此构件穿过柄部的顶盖或壳板106、以螺纹旋入压紧配件或螺母108并且固定在圆形构件或垫板110上面。可以看出,一条拉线24固接在构件108上面。由图6B和6D可见,转动旋钮或拨钮100会放松或上紧连续槽道112(图6D)中的压紧配件108,使得有可能在需要时前后调节拨钮100。这样就可以往复地调节拉线24。
此控制装置可以单独操作,或者在往复滑动方面协同内调整式导管一起使用。如前所述,导管端部14当然可以做成具有任何所需要的挠曲抗力或肖氏硬度,并使之具有记忆效应以返回予先设定的位置;但一般希望导管管筒在拉线上的张力解除后能返回伸直位置。
柄部的另一些适于同图1A、1B、2A和2B中所示的导管实施例一起使用的实施例描绘在图7A和7B之中。这些实施例的特征是,用于拉线的姆指操作式滑动拨钮是靠摩擦止动的,既可用于切除式导管器械,也可用于鞘套式导管器械。图7A中,柄部整体由120标示,包括一对沿纵向可调的姆指操作式拨钮构件122和124,可滑动地安装在各自的槽道126和128之中,固接在各自的拉线130和132上面,并且同内导管134一起伸出近侧主导管管筒136。密封的鞘套通路示于138。
图7B表明纵向对中型的切除式柄部140,其中姆指操作式拨钮142和144沿纵向对中在控制拉线148和150的槽道146里面,拉线穿出主导管154里面的内导管152。电力连接是靠156所表示的导线束实现的,塞孔式插接连接器示于158。
本发明的一个重要方面是,提供一种导管,其中很容易取得当不同用途提供特定形状的特定变位或弯曲变形。图8、9A-9C和10描绘了本发明的一项具有高度操纵灵活性的可复位导管的备用实施例,它采用了更为独特的内管式变位导向构件。
图8表明一种极易变位的切除式导管的远侧挠性端部,有的部分截掉了,一部分取剖面以显示内部细节。此导管具有主或外导管管筒162,在它上面做出一组沿纵向间隔开的切口或凹槽,如164处所示。导管管段162可以采用同图1A和1B中导管14所采用的几乎一样的已知导管技术和材料加以制造。当然,任何其他适合的材料或制造技术也是可以采用的。这组切口或凹槽164形成了长长的变位段,从接近于如环状电极166和端头电极168所表示的各远侧电极的某一部位出发向近侧延伸过来。导管162的挠曲由一条或多条锚固在如170处所示的导管内壁上的如172处所示的拉线来控制,并且贯穿导管的整个长度,通过内管筒174的管腔。拉线的另一条可供代换的线路示于173。
与图8中实施例的一个重要方面相符合,导管管筒162的变位由一部沿纵向可灵活操纵的,或者说可往复操作的,空心管状导管变位导向构件或者形状控制装置176进一步加以限定和控制,此控制装置具有如178处所示的一个或多个狭长的切口段,或者换一种方式,它可以配有几段削弱部位或者作为具有不变的挠曲抗力的一段管筒而加以利用。管状构件176在外导管162的管腔里面可灵活地滑动,其方式能使切口178或者远侧端头相对于切口或凹槽164组群按需要加以配置,以便控制导管162的挠曲。此装置设计得使导管162在受到张力或拉线172、172指引或控制时由于设置切口178而进一步受到限定将优先在凹槽164的方向上弯曲。另外,设置蒙皮或外膜180以复盖凹槽164并保持导管内腔完全无体液进入。
图12是类似于图8的一幅视图,其中采用沿轴向可调节的(往复式)挠曲细轴或变位形状线式控制元件220来代替(或者可能伴同)内管件176。构件220可以包括一个或多个具有低挠曲抗力(亦即小截面)的、或者说是可伸张的、由多段刚硬或大直径区段224顺序隔开的区段222。可供选择的是,此构件可以是如虚线225所示的一根等直径的连续杆件。构件220可以连同其他象张力控制拉线172、173那样的控制构件一起穿过内管腔或管筒,如226处所示。当然,电导线是比较脆弱的,必须具有与控制拉线和变位形状控制器分开的线路。构件220的近侧延伸段228伸向一只近侧的外部控制手柄,可以使之象一条拉线或图8中管筒176那样往复,以便实现相对于柄部主体162的轴向精细调节。
如图12所示,构件220的依次柔软和刚硬的形态,就挠曲方向的优选性而论,可能是无定向性的。在这种结构情况下,象图8中的实施例一样,挠曲方向的控制可以靠相对于诸如切口164那样的削弱部位安置一个或多个区段222、224并采用可产生变位张力的元件276而予以实现。如图13所示,非对称侧壁的管筒262-其一部分侧壁264沿半径方向比较薄,相比之下其侧壁266,含有加强筋268,则虽是挠性的但较为刚硬-可以提供用于优先产生导管挠曲的削弱部位。
当然,沿导管一处或几处弯曲的精确位置可以通过在一定的导管端部某一削弱这段或者可能某几个这样的区段里面沿轴向配置一个或多个挠曲点222的办法加以控制。在具有等直径的管件176或杆件220等的情况下,得到控制的导管挠曲将发生在邻近构件220远侧端头的地方。各区段222和224的相对长度同样与设计抉择有关,将主要取决于所需要的特定形状,这方面的实例示于图9A-9C。
当然,构件220可以是一种细丝或线,其中222和224所表示的区段都是基于冶金或成分方面的考虑而具有或大东小挠性的区段,而不是由于单一成分下尺寸的不同。同样,比如说,可以使用具有或大或小挠性的聚合物或塑料,或者类似的材料。如果需要的话相对强度或挠性可以做成是沿径向非对称性的或单向的或双向的,以便其本身有助于控制导管的形状。
还应当认识到,形状控制系统中所有的协作构件或元件都是挠性的,而且是靠调配元件之间刚性或挠性的相对差别使得可能产生所希望有的形状而获得控制的。这涉及到:比如,导管管筒64、162,管筒176处,构件220,或者,从安置如56、172等处所示的张紧控制构件的角度来看,其他的挠性调整构件。
按照本发明,甚至用以下方法可以达到控制目的:采用一根一般的柔软甚至松弛的等刚度的导管远侧管段,此管段带有一个或多个锚固支管壁上的张紧控制构件,用来调整包括一个或多个挠曲点在内的挠曲特性,调整的办法是,沿轴向调节(前后移动)变位形状控制或调整装置的远侧端头,或者需要时调配一个或多个具有附加挠性的部位;并采用拉线或张紧线以造成所需要的形状而产生任何一个或多个挠曲点以及任意需要的挠曲度。
如上所述,构件220的轴向定位(往复移动)可以用连接在近侧管段228上面的几种往复装置中的任何一种予以实现,其本身可以穿过导管的整个长度达到操作手柄控制器,如图3A-7B中的例证所示。端头控制根据的是在相对于导管162、262的合适位置上沿轴向协调匹配合适的一个或多个挠性区段222。如176处所示不带削弱部位的比较刚硬的细长内筒也可以用来结合构件220遮蔽一个或多个近侧挠性区段222,致使只有比较处于远侧的(伸出内筒的)那些区段才会挠曲。在任何情况下,一旦达到恰当的匹配,操作拉线就可很容易地实现挠曲。
图9A-9C示意性地描绘了配合使用内管式复位导引构件176或者轴式或线式构件220时导管162的不同挠曲形状的一些实例。图9A描绘了由于管件176向凹槽164的近侧撤回以致拉线172中的张力在导管162的远侧端头中造成一条连续的弧形曲线时,装置是如何变位的。图9B描绘了一种情况,其中导管端头处的一些凹槽164越出内管件176或者线式或轴式构件220的端部,因而在该处导管的挠曲是不受限制的。这样在192处就产生了弯折或弯曲以及按照切口178或挠曲区段222的位置确定的在194处的另一弯曲。图9C显示了一种配置,其中唯一的弯曲是由切口178或挠曲段222在196处造成的。
很容易看出,由图8和12作为例证显示的各个实施方案适合于导管远侧端头需要实时形状调节以提供某些专门功能的各种应用场合。导管控制或变位导引内管176,或者构件220,可以在数量、尺寸和切口的角度配置方面以任何方式加以设计,以便在导管162中产生所希望有的挠曲形状。
还应当指出,导管壁上优先挠曲的一段或几段削弱或关节部分可以采取任何特殊的具体方式做成任何长度。当然,目的是使使用者能够把一只或多只切除和/或记录电极置放在某一位置以达到心室或阀瓣表面的某一特定部位。要达到如果使用早先的形状控制技术就难以连续接触的那些部位,特别需要一些不同寻常的形状。一定要记住,导管必须具有把电极装置置放到同细胞组织保持持久接触的能力,细胞组织基本上是不断运动的,跳动的心脏就是如此。在说明了远侧各电极166和168之后,就会进一步理解,具有任何合适尺寸、间距和数量的记录和/或切除电极都是可以采用的。
图10是结合图8和12中所描绘的导管实施例一起使用的一种柄部的实例。它包括其整体以标号200标示出的柄部,其中主导管202的近侧端可以在柄部里面往复地移动,移动的长度等于槽道或键槽204的长度,此槽道协同固定螺丝206可调整导管202的纵向位置。变位拉线或张紧线173穿过变位导引构件176(或者筒226,图12),其近侧端固定在构件208上面,此构件可以是一只靠螺纹接合的张力调节螺丝,其中张力可在柄部装配期间事先调定。210处所示是另一种手动式纵向导管的手指操作式移动手柄,可以用来往复地调节导管的位置,从而调整导管装置远侧端部上拉线173的张力以控制端头的挠曲。
另一种手指操作的往复式或变位导引内管式定位装置212,如图所示,固接在内导管176上面(但是也可以固接在构件220的近侧导引头228上面),用来可滑动地调节内导管176(或构件220)的位置,以便随需要恰当地设置一个或多个切口178(图8)(或挠性区段222)以产生导管162中恰当的变位模式(图8和12)。如图所示,电导线的连接不与导管管筒202的往复移动毫不相干,以致在装置使用期间没有张力加在如图所示连接在塞孔式插接器件214上面的电导线上面。
本发明至此已作了相当详细的说明,为的是履行专利法规,并向本技术领域中的熟练人员提供在必要的情况下应用各项新颖原理和设计并采用各种实施例时所必需的信息。不过,应当理解:只要不偏离本发明本身的范畴,本发明可以用许多不同的具体装置加以体现,可以实施各种各样的改型。
Claims (65)
1、一种变位装置,用于精确控制管式脉管导管的、包括挠性的工作导管远侧区在内的导管远侧段的形状,此装置包括:
(a)导管远侧段,具有外壁、远侧端头和近侧端头,并包括这侧工作尖端区;此远侧段的形状是要寻求控制的;
(b)一个或多个顺序间隔开的、相对薄弱的或比较柔软的管壁部位,用于在距离导管远侧段的远侧端头处的导管远侧段的外壁上、在优选的方向上产生较大的挠曲,每一薄弱部位为导管造成一种在薄弱壁段的方向上并在此薄弱壁段的附近优选发生弯曲的趋势;
(c)挠曲控制装置,包括用于从薄弱壁段的远侧向导管远侧段施加可调节的张力的、可往复操作的装置,施力方式是,使导管在一处或多处薄弱壁段上在薄弱壁段恰当的方向上并在此薄弱壁段的附近产生弯曲。
2、按权利要求1中所述的装置,其特征在于还包括许多薄弱壁段,而且其中所述挠曲控制装置包括许多可往复操作的装置,此中每一所述可往复操作的装置在不同于所述薄弱壁段位置的远侧位置上固接在导管管壁上。
3、按权利要求1所述的装置,其特征在于,进一步包括许多对齐排列在不同径向方向的顺序罗列的相对薄弱的壁段。
4、按权利要求2中所述的装置,其特征在于,进一步包括许多对齐排列在不同径向方向的顺序罗列的薄弱壁段。
5、按权利要求1中所述的装置,其特征在于,其中薄弱壁段包括切口。
6、按权利要求3中所述的装置,其特征在于,其中薄弱壁段包括切口。
7、按权利要求1中所述的装置,其特征在于,其中一个或多个相对薄弱壁段的特征是,顺着半径方向上减小管壁厚度。
8、按权利要求3中所述的装置,其特征在于,其中一个或多个相对薄弱壁段的特征是,顺着半径方向上减小管壁厚度。
9、按权利要求5中所述的装置,其特征在于,进一步包括盖过切口的挠性外覆蒙皮装置,以便保持导管远侧段的完全液密性。
10、按权利要求1中所述的装置,其特征在于,其中挠曲控制装置包括一条或多条张紧拉线。
11、一种可控变位装置,用于精确控制管式脉管导管的、包括挠性的工作导管远侧区在内的导管远侧段的形状,此装置包括:
(a)导管远侧段,具有外壁、远侧端头和近侧端头,并包括远侧工作区;此远侧段的形状是要寻求控制的;
(b)一个或多个顺序间隔开的、相对薄弱的或比较柔软的管壁部位,用于距离其远侧端头较近处的导管远侧段的那部分外壁上、在优选的方向上引发较大的挠曲,每一薄弱壁段为导管造成一种在薄壁段的方向上和位置上优选发生弯曲的趋势;
(c)挠曲控制装置,包括用于从薄弱壁段的远侧向导管远侧段施加可调节的张力的、可往复操作的装置,施力方式是,使导管害一处或多处薄弱壁段的地方、在希望有的方向上发生弯曲;以及
(d)可调节的变位形状控制装置,配置在所述导管远侧段之中,并可在其中往复滑动以协同所述一个或多个薄弱壁段和所述挠曲控制装置来调整导管远侧段所采取的形状。
12、按权利要求11中所述的装置,其特征在于,进一步包括许多薄弱壁段,而且其中所述挠曲控制装置包括许多可往复操作的装置,此中每一所述可往复操作的装置在不同于所述薄弱壁段位置的远侧位置上固接在导管管壁上。
13、按权利要求11中所述的装置,其特征在于,进一步包括许多对齐排列在不同径向方向的顺序罗列的相对薄弱的壁段。
14、按权利要求12中所述的装置,其特征在于,进一步包括许多对齐排列在不同径向方向的顺序罗列的薄弱壁段。
15、按权利要求11中所述的装置,其特征在于,其相对薄弱壁段包括切口。
16、按权利要求4中所述的装置,其特征在于,其中相对薄弱壁段包括切口。
17、按权利要求11中所述的装置,其特征在于,其中一个或多个相对薄弱壁段的特性是,顺着半径方向上减小管壁厚度。
18、按权利要求13中所述的装置,其特征在于,其中一个或多个相对薄弱壁段的特征是,顺着半径方向上减小管壁厚度。
19、按权利要求15中所述的装置,其特征在于,进一步包括盖过切口的保护性的挠性外覆蒙皮装置,以便保持导管远侧段的完全液密性。
20、按权利要求11中所述的装置,其特征在于,其中可调节的变位形状控制装置包括细长的挠性实心构件。
21、按权利要求11中所述的装置,其特征在于,其中可调节的变位形状控制装置包括具有一个或多个间隔开的低刚度区段的细长挠性实心构件。
22、按权利要求21中所述的装置,其特征在于,其中可调节的变位形状控制装置是具有一个或多个小直径区段的线或杆。
23、按权利要求11中所述的装置,其特征在于,其中可调节的变位形状控制装置包括细长的挠性空心构件。
24、按权利要求11中所述的装置,其特征在于,其中可调节的变位形状控制装置包括具有一个或多个间隔开的高挠性区段的细长空心构件。
25、按权利要求11中所述的装置,其特征在于,其中可调节的变位形状控制装置包括有些部分从其侧壁上切除掉的空心管件,以构成所述在一定方向上优先具有较大挠性的各个区段。
26、按权利要求11中所述的装置,其特征在于,其中可调节的变位形状控制装置包括结合细长的空心构件一起工作的细长的实心构件。
27、按权利要求11中所述的装置,其特征在于,进一步包括在所述导管工作段上面的一部或多部记录/切除电极装置。
28、按权利要求1中所述的装置,其特征在于,进一步包括在所述导管工作段上面的一部或多部记录/切除电极装置。
29、一种变位装置,用于控制管式导管的、包括导管远侧工作区在内的导管远侧段的形状,此装置包括:
(a)导管远侧段,挠性理想,具有外壁、远侧端头和近侧端头,并包括远侧工作区;此远侧段的形状是要寻求控制的;
(b)挠曲控制装置,包括用于在外壁区段上的一个或多个固接位置上向导管远侧段施加可调节的张力或拉力的、可往复操作的装置,施力方式是,使作用力方向上的相应固接位置附近的导管远侧段产生弯曲;以及
(c)可调节的变位形状控制装置,配置在所述导管远侧段之中,并可在其中往复滑动以协同所述导管远侧段和所述挠曲控制装置来调整导客远侧段所采取的形状。
30、按权利要求29中所述的装置,其特征在于,其中可调节的变位形状控制装置包括具有一个或多个间隔开的较大挠性区段的细长挠性实心构件。
31、按权利要求29中所述的装置,其特征在于,其中可调节的变位形状控制装置包括具有不变刚度的细长挠性实心构件。
32、按权利要求29中所述的装置,其特征在于,其中可调节的变位形状控制装置是具有一个或多个小直径区段的线或杆。
33、按权利要求29中所述的装置,其特征在于,其中可调节的变位形状控制装置包括细长的挠性空心构件。
34、按权利要求29中所述的装置,其特征在于,其中可调节的变位形状控制装置包括具有一个或多个间隔开的较大挠性区段的细长空心构件。
35、按权利要求32中所述的装置,其特征在于,其中较大挠性的区段是按方向定向的。
36、按权利要求29中所述的装置,其特征在于,其中可调节的变位形状控制装置包括有些部分从其侧壁上切除掉的空心管件,以构成所述在一定方向上优先具有较大挠性的各个区段。
37、按权利要求29中所述的装置,其特征在于,其中可调节的变位形状控制装置包括结合细长空心构件装置一起工作的细长实心构件装置。
38、按权利要求29中所述的装置,其特征在于,进一步包括在所述导管工作区上面的一部或多部记录/切除电极装置。
39、按权利要求1中所述的装置,其特征在于,其中挠曲控制装置进一步包括一个手柄装置,此装置带有连接起来的至少一个用手操作的可往复调节的拨钮装置,以挪动每一个可往复操作的装置,从而调整导管端头的变位。
40、按权利要求39中所述的装置,其特征在于,其中所述至少一个用手操作的可往复调节的拨钮装置沿着一组间隔开的、事先定好的固定位置运作,并进一步包括特定弹簧装置以保持拨钮装置处在所需要的固定位置上。
41、按权利要求39中所述的装置,其特征在于,其中所述至少一个用手操作的可往复调节的拨钮装置是可滑动地安装在槽道中的。
42、按权利要求1中所述的装置,其特征在于,其中挠曲控制装置包括:
(a)许多可往复操作的控制拉线,一一锚固在每一挠性较大的区段的稍远处;以及
(b)用于控制每一条这种控制拉线的往复运动的装置。
43、按权利要求42中所述的装置,其特征在于,其中用于控制每一条控制拉线的往复运动的装置进一步包括手柄装置,此装置带有许多用手操作的可往复调节的旋钮装置,每一个都连接好以往复地移动各自的控制拉线,用来施力并调整导管端头的复位。
44、按权利要求42中所述的装置,其特征在于,其中至少一个用手操作的可往复调节的旋钮装置沿着一组间隔开的、事先定好的固定位置运作,并进一步包括特定弹簧装置以保持旋钮装置处在所需要的固定位置上。
45、按权利要求42中所述的装置,其特征在于,其中至少一个用手操作的可往复调节的旋钮装置可滑动地安装在槽道里面。
46、按权利要求29中所述的装置,其特征在于,其中挠曲控制装置进一步包括手柄装置,此装置具有连接起来的至少一个用手操作的可往复调节的旋钮装置以移动每一个可往复操作的装置,从而调整导管端头的复位。
47、按权利要求46中所述的装置,其特征在于,其中至少一个用手操作的可往复调节的旋钮装置沿着一组间隔开的、事先定好的固定位置运作,并进一步包括特定弹簧装置以保持旋钮装置处在所需要的固定位置上。
48、按权利要求46中所述的装置,其特征在于,其中至少一个用手操作的可往复调节的旋钮装置可滑动地安装在槽道之中。
49、按权利要求29中所述的装置,其特征在于,其中挠曲控制装置包括:
(a)许多可往复操作的控制拉线;以及
(b)用于控制每一条这种控制拉线的往复运动的装置。
50、按权利要求49中所述的装置,其特征在于,其中用于控制每一条控制拉线的往复运动的装置进一步包括手柄装置,此装置带有许多分别地用手操作的可往复调节的旋钮装置,每一个都连接好以便往复地移动各自的控制拉线,用来施力并调整导管端头的复位。
51、按权利要求49中所述的装置,其特征在于,其中至少一个用手操作的可往复调节的旋钮装置沿着一组间隔开的、事先定好的固定位置运作,并进一步包括持定弹簧装置以保持旋钮装置处在所需要的固定位置上。
52、按权利要求49中所述的装置,其特征在于,其中至少一个用手操作的可往复调节的旋钮装置可滑动地安装在槽道之中。
53、用于脉管导管的可精确控制的导管远侧段包括:
(a)空心的细长管式导管远侧工作段,具有远侧端头、近侧端头和外壁,并描画出至少一个主内管腔;
(b)张力控制装置,用于从一个或多个削弱区段的远侧向导管远侧段施加纵向力,施力方式是,促进其在削弱区段的方向上产生弯曲;
(c)变位形状控制装置,配置在所述导管远侧段之中,并在其中可往复滑动以调整所述一个或多个削弱壁段与所述张力控制装置之间的配合关系,供以调整导管远侧段所采取的形状;以及
(d)手柄装置,具有连接起来的至少一个用手操作的可往复调节的旋钮装置以便往复地调节每一个张力控制装置,还有连接起来的可调节的旋钮装置以便往复地调节导管的形状控制装置,借以调整导管变位的部位和大小。
54、按权利要求53中所述的装置,其特征在于,其中每一旋钮装置沿着一组间隔开的、事先定好的固定位置运作,并进一步包括把旋钮装置保持在所需要的固定位置上的装置。
55、按权利要求53中所述的装置,其特征在于,其中可调节的变位形状控制装置进一步包括具有一个或多个间隔开的较大挠性区段的细长空心构件。
56、按权利要求53中所述的装置,其特征在于,其中可调节的变位形状控制装置是具有不同直径区段的线或杆。
57、按权利要求53中所述的装置,其特征在于,其中变位形状控制装置是带有一个或多个间隔开的削弱区段的管件,可滑动地往复于工作导管的外面。
58、用于脉管导管的可精确控制的导管远侧段包括:
(a)空心的细长管式导管远侧工作段,具有远侧端头、近侧端头和外壁壁并描画出至少一个主内管腔,其形状是要寻求控制的;
(b)一条或多条控制拉线,固接在每一个有待分别变位的区段的远侧处、导管远侧段的外壁上面,并穿过导管的整个长度;
(c)手柄装置,具有固接在每一条控制拉线和每一个变位形状控制装置上面的可往复调节的装置;手柄装置的操作方式是:施加在控制拉线上的张力使有关的导管部位沿着控制拉线固接点的移动方向产生相应的变位,固接点是按照一个和多个形状控制构件区段而予以变换的;而解除张力会使变位反向;以及
(d)一个或多个变位形状控制构件,配置城所述导管远侧段之中,并可在其中往复地滑动以配合所述挠曲控制装置来调整变位的大小和部位,从而确定导管远侧段所采取的形状。
59、一种可控制导管远侧段成形的方法,包括:采用张力控制装置,此装置包括用于从希望发生挠曲的部位的远侧处、导管远侧段的侧壁出发向导管远侧段施加可调节的纵向力的可往复操作的装置;还采用沿轴向可滑动地调节的变位形状控制装置,配置在所述导管远侧段之中,并可在其中往复地滑动以配合所述张力控制装置来调整导管远侧段所采取的形状。
60、一种控制导管远侧段形状的方法,包括:采用一个或多个在导管远侧段外壁上的、具有可选择的不同径向的削弱壁段;这些壁段距离导管远侧段的远侧端头较近,与一个或多个往复式拉力控制装置相结合;这种装置包括用于从削弱壁段的远侧各点向导管远侧段施加可调节的纵向力的往复操作式装置,还采用可滑动地调节的变位形状控制装置,配置在所述导管远侧段之中,并在其中可往复地滑动以协同所述一个或多个削弱壁段和所述挠曲控制装置来调整导管远侧段所采取的形状。
61、一种形状控制装置,用于控制挠性管式脉管导管的远侧段挠曲形状,包括:
(a)挠性管式主导管,具有远侧端头和近侧端头以及远侧工作段;此主导管的展散形状是要寻求控制的,它并且描画出连续的主内管腔;
(b)一个或多个弯曲区域,具有在变位方向上带优先性的较大挠性,离主导管远侧段的远侧端头较近;
(c)挠曲控制装置,包括用于从变位区段的一个或多个弯曲区域的远侧向导管远侧段施加纵向力的一个或多个张紧构件,施力的方式使得变位区段在每一弯曲区域的优先方向上产生弯曲;
(d)挠性变位形状控制构件,可以选定为空心管筒或实心杆件,此控制构件包括内管式变位导引构件,配置在导管的主管腔内并使之具有可在其中往复滑动的外形;变位形状控制构件本身可任随选择地带有一个或多个挠性较大的区段,这种区段所具有的形式能促进导管在形状控制构件中挠性较大的区段与导管弯曲区域协调一致的那些部位上发生弯曲;
(e)变位导引控制装置,用于往复地调节变位形状控制构件;以及
(f)其中借助于可滑动地调节变位形状控制构件来相对地调整变位形状控制构件的一个或多个削弱区段的这种办法可以用于改变主导管的弯曲状况。
62、按权利要求61中所述的装置,其特征在于,其中挠曲控制装置包括:
(a)一条或多条可往复操作的控制拉线,锚固在外导管上正好离变位区段稍远的地方;
(b)控制拉线的往复运动控制装置;以及
(c)其中变位形状控制装置包括固接在变位形状控制构件上的手指操作式控制装置,用于往复地调节变位形状控制装置。
63、按权利要求62中所述的装置,其特征在于,其中控制拉线的往复运动控制装置进一步包括手柄装置,此装置具有连接在控制拉线上的手动式可往复调节的旋钮装置,用于控制控制拉线的往复运动,可操作此旋钮装置以调整施加在导管远侧段上面的纵向力。
64、按权利要求62中所述的装置,其特征在于,其中至少一个手动式可往复调节的旋钮装置沿着一组间隔开的、事先定好的固定位置运作,并进一步包括持定弹簧装置以保持旋钮处在所需要的固定位置上。
65、按权利要求62中所述的装置,其特征在于,其中至少一个手动式可往复调节的旋钮装置可滑动地安装在槽道之中。
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US08/148,598 US5441483A (en) | 1992-11-16 | 1993-11-08 | Catheter deflection control |
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ES2165379T3 (es) | 2002-03-16 |
CA2149417C (en) | 2007-04-03 |
CA2149417A1 (en) | 1994-05-26 |
WO1994011057A1 (en) | 1994-05-26 |
US5441483A (en) | 1995-08-15 |
JP3752564B2 (ja) | 2006-03-08 |
DE69330914D1 (de) | 2001-11-15 |
EP0713408B1 (en) | 2001-10-10 |
JP2002512534A (ja) | 2002-04-23 |
DE69330914T2 (de) | 2002-06-13 |
EP0713408A4 (en) | 1996-02-27 |
AU5608394A (en) | 1994-06-08 |
EP0713408A1 (en) | 1996-05-29 |
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