CN102895027B - 具有流量平衡阀的导管 - Google Patents
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Abstract
本发明提供一种导管,其具有至少两个冲洗消融电极和用于将流体通过单独并且专用的流动通道输送到所述电极的同轴冲洗配管。阀门用来借助于柱塞组件控制进入所述同轴冲洗配管的流体的流动,所述柱塞组件允许流体流过所述同轴冲洗配管的一个管腔,同时响应于所述流体流量和施加到所述柱塞组件的压力调节进入所述同轴冲洗配管的另一管腔的所述流。
Description
技术领域
本发明整体涉及用于侵入式医学治疗的方法和装置,并且更具体涉及导管,特别是冲洗消融导管。
背景技术
心肌组织消融是熟知的心律失常治疗手段。例如,在射频(RF)消融中,将导管插入心脏并在目标位置处与组织接触。然后通过导管上的电极施加RF能量,以便形成损伤灶,其目的是破坏组织中的致心律失常电流通路。
消融主要借助于局灶性消融,即由导管远端处的尖端电极进行的消融,来实现。因此,对于沿直线或曲线的线性消融来说,在延长的消融期间,尖端电极被反复再定位或沿直线或曲线拖过组织。
在消融期间有效降低电极温度以最小化烧焦和凝结物的形成的冲洗消融尖端电极和环电极也是已知的。然而,对患者的流体负荷是一个问题,特别是在多个电极被冲洗的情况下。
现有EP导管利用单个冲洗管腔将冲洗液输送到一个或多个冲洗电极。因此使用由一个泵头组成的泵装置。随着导管变得更加复杂,对于多个冲洗管腔的需求变得更加迫切。目前,需要使用多个泵装置将冲洗液输送到具有多个冲洗管腔的导管。
因此,需要一种适于进行局灶性消融和线性消融两者的导管,以便在不用再定位导管的情况下实现线性损伤。具体地讲,需要一种具有尖端电极和环电极的导管,其能以不同流量向不同电极提供冲洗流体,而不需要多个泵。
发明内容
本发明涉及一种冲洗导管,其具有从中输送冲洗液的至少两个管腔和平衡进入两个管腔的流量的阀门。在尖端电极由一个流体管腔冲洗且多个环电极由另一个流体管腔冲洗的线性消融导管(即,适于形成大致连续的细长损伤灶的导管)的情况中,流体被泵送至导管并且通过导管流至尖端电极和该组环电极的流量在不使用外部输入或调节的情况下被控制。通过使用同轴冲洗配管和具有柱塞组件的阀门来实现所需流量控制,当供应至导管的总流量变化时,柱塞组件调节在两个冲洗管腔之间的流量比率。
在一个实施例中,阀门具有容纳阀门的部件的主体。阀门包括入口开口和出口开口,其中入口开口可以是用于对连接至流体源的配管进行连接的内螺纹鲁尔锁连接器,并且出口开口可以是内螺纹端部,同轴冲洗配管可从控制手柄延伸通过该内螺纹端部进入阀门。
在一个实施例中,柱塞组件包括柱塞头、弹簧构件和基部,其中,柱塞头和基部具有通孔,该通孔用于接纳同轴冲洗配管的第一管腔以提供沿纵向轴线通过阀门的第一流动通道。柱塞可沿纵向轴线发生位移,以提供绕过柱塞的第二流动通道。同时,根据位移程度,柱塞可改变流过第二流动通道的流体的流量或量。例如,柱塞可仅允许泄漏以提供通过第二流动通道的最小流量,或者柱塞可允许通过第二流动通道的更大流量。柱塞可采取圆锥、球体、平坦密封或用于调节流量的任何其他合适构型的形式。通过选择具有已知常数k的弹簧构件,可以计算和预测作为柱塞上的流体压力的函数的柱塞的位移。然而,虽然虎克定律指出弹簧的回复力F与小位移量x成正比 (即F=kx,其中k为所用特定弹簧构件的比例常数),但由于柱塞的构型,柱塞的位移不一定是压力的线性函数。
在一个详细的实施例中,本发明的导管包括:细长主体;远侧段,该远侧段至少具有第一电极和第二电极,每个电极适于冲洗;和控制手柄,该控制手柄邻近细长主体。有利地,导管还包括至少具有内管腔和外管腔的同轴冲洗配管,内管腔专用于输送流体到第一电极,并且外管腔专用于输送流体到第二电极。
在一个详细的实施例中,本发明的阀门包括主体,该主体限定入口开口、出口开口和连接入口开口与出口开口的内部腔体,其中入口开口适于以可变的预定流量接纳流体流。阀门包括柱塞组件,该柱塞组件具有柱塞头、基部和在相对于入口开口的预定位置处从基部支撑柱塞头的弹簧构件。形成为延伸穿过柱塞头和基部的第一管腔接纳流入入口开口的流体流的无阻碍部分,以限定通过阀门的第一流动通道。然而,柱塞头自身将流体流的剩余部分朝第二流动通道转向,第二流动通道的横截面根据柱塞头在冲击到柱塞头的流体流的压力下的位移程度而变化。因此,主体限定第一和第二流体流动通道,其中第一流体通道包括第一管腔而非内部腔体,并且第二流体流动通道包括内部腔体而非第一管腔,使得第一流动通道接纳经由入口开口进入阀门的流体流的第一或主要部分,并且第二流动通道接纳经由入口开口进入阀门的流体流的第二或剩余部分。为此,弹簧构件适于在入口开口流量超过阈值时允许柱塞头位移以改变进入第一和第二流体通道的流体流的至少一部分。
本发明还涉及一种用于消融的系统,在一个实施例中,该系统包括适于消融的导管,该导管至少具有第一电极和第二电极以及同轴冲洗配管,同轴冲洗配管被构造成具有在导管内的至少两个单独的流体通道以用于将流体输送到每个电极。该系统还包括:消融能发生器,该消融能发生器被构造成选择性地激励第一和第二电极;冲洗泵,该冲洗泵响应于来自消融能发生器的、指示至少一个电极的激励状态的信号。有利地,该系统还包括阀门,该阀门被构造成接纳来自流体源的流体以输送到同轴冲洗配管,其中,冲洗泵适于根据来自消融能发生器的信号将流体以所选流量泵送到导管,并且其中阀门具有适于以两种不同的流量输出两个单独的流体流的柱塞组件。
附图说明
结合附图阅读以下具体实施方式,将更好地理解本发明的这些和其他特征以及优点。应该理解,选定的结构和特征在某些附图中没有示出,以便更好地观察其余的结构和特征。
图1是根据本发明的导管的实施例的透视图。
图2是根据本发明的一体化消融系统的实施例的透视图。
图3是图2的系统的框图。
图4A是根据本发明的导管的中间段的实施例的端剖视图。
图4B是图1的导管的侧剖视图,其包括导管主体与沿一直径截取的可偏转中间段的接合部。
图4C是图1的导管的中间段的实施例的端剖视图。
图5是图1的导管的远侧段的实施例的侧正视图,其接触组织以通过消融形成损伤灶。
图6A是沿一直径截取的图5的远侧段的局部侧面剖视图。
图6B是沿另一直径截取的图5的远侧段的局部侧面剖视图。
图6C是沿C--C线截取的图5的远侧段的端剖视图。
图7是冲洗环电极的实施例。
图8是根据本发明的导管的中间段和远侧段之间的接合部的实施例的侧剖视图。
图9是根据本发明的阀门的实施例的侧剖视图,示出了一种构型的柱塞组件。
图9A-9D分别是图9的阀门沿A--A、B--B、C--C和D--D线截取的端剖视图。
图10是图9的阀门的侧剖视图,示出了另一种构型的柱塞组件。
图11是柱塞头的近侧面的实施例的端视图。
图12是根据本发明实施例的用于心脏组织消融的系统的示意性说明图。
图13是示出用于系统的各种操作条件的样本流体流量的表。
具体实施方式
如图1所示,本发明包括可操纵导管10,其具有包括尖端电极T和多个环电极R的多个电极,并具有用于单独地输送流体到尖端电极和环电极的同轴冲洗配管。导管布置在身体的靶区域例如心脏的心房中,并且设计成有利于借助于射频(RF)电流沿靶组织的线性消融。导管有利地设计为形成大致连续的RF损伤灶,而不需要再定位导管。一旦就位,导管就可保持位置,从而通过电极选择性地输送RF能量,以形成大致连续的RF损伤灶。在一个实施例中,RF能通过作为单极电极的环电极中的每一个输送到接触靶组织再到返回电极(例如,固定到患者背部的外部电极贴片),以实现单极局灶性损伤。然后,为了“连接”单极损伤灶以便形成大致连续的线性损伤灶,通过激励作为双极电极的环电极而消融在每个局灶性损伤之间的组织,以在环电极之间形成双极损伤灶。因此,导管允许更快形成损伤灶,同时减少导管操纵。
如图2和3所示,导管10可与一体化的消融系统S一起使用,在一个实施例中,一体化的消融系统S包括外部控制系统,例如,多通道RF发生器11,其具有RF消融控制器13、泵头控制器15和可视显示器25。系统S 还包括冲洗泵27,冲洗泵27具有与运动控制器MC通信的自动控制接收器 19,运动控制器MC控制作用于流体配管上的泵头PH,流体配管在流体源FC和导管控制手柄附近的鲁尔插头之间延伸。
RF发生器11具有允许基于消融设置自动操作泵头的内置逻辑。RF发生器上的用户界面23允许用户修改或限定用于操作泵的定制参数,以增加对过程的控制。
在多通道RF发生器11上以设置的瓦特数提供消融。冲洗泵27可以是利用正排量泵送流体的蠕动泵或滚子泵。如本领域的普通技术人员所理解的,蠕动泵具有装配在泵壳体内部的柔性管,蠕动泵通常为环形的,但也可以使用线性蠕动泵。此外,冲洗泵还可包括气泡传感器、闭塞传感器或用于泵的安全操作的任何其他传感器。
多通道RF发生器11根据由操作者经由用户界面23设置和控制的消融参数引导RF电流通过所选电极。例如,(i)可同时激励所有电极,(ii)可激励尖端电极,而非所有环电极,并且(iii)反之亦然,(iv)可激励尖端电极和选择的环电极的组合,或者(v)可激励所有或仅选择的环电极。此外,任何组合或顺序的任何这一系列的激励模式都是可能的,全部消除了在线性损伤灶消融期间再定位导管的需要。
在消融期间,多通道RF发生器也监测所涉及的(多个)电极的温度并且在温度超过用户设置的值时降低瓦特数。导管温度信息从导管上的热电偶发送到RF发生器。
根据本发明,RF发生器11也经由泵头控制器15与冲洗泵27通信以根据电极的选择性激励控制冲洗流输送,以便优化进入导管的流体流。通信可使用电缆连接、诸如的无线通信技术、或通过无线电信号 (例如,以2.4GHz或用于医学实验室环境的其他合适频率发送)来实现。
响应于由RF消融控制器13产生的指示每个电极的激励状态或“条件”的消融/激励信号,与RF消融控制器13通信的泵头控制器15发送合适的信号至冲洗泵27的自动控制器接收器19,以控制用于泵头PH的运动控制器MC。响应于该信号,运动控制器MC可启动泵头PH以开始或停止流动和/或增加或减小流量。也就是说,在RF能量被输送通过一个电极或一组电极的同时,RF发生器触发对应的泵头以根据被激励的(多个)电极以所需流量输送流体。例如,如果RF能量被施加到所有电极或者如果增加用于任何电极的RF能量,则RF发生器触发泵头以在更高的流量下输送流体,以便在周围区域中扩散血液和最小化由于增加的电极发热导致的烧焦和凝结物的形成。如果RF能量被施加到更少电极,则RF发生器触发泵头以在足以冲洗消融电极的更低流量下输送流体,同时最小化对患者的流体负荷。如本领域的普通技术人员所理解的,通过不活动激励电极的最小流量被大体上维持,以便冲刷电极中的冲洗孔并最小化阻塞的风险。操作者也可根据需要经由用户界面29人工控制泵头。
参见图1,根据所公开的实施例的导管10包括:细长主体,该细长主体可包括具有纵向轴线的插入轴或导管主体12;和在导管主体远侧的中间段14,中间段14可从导管主体单向或双向可偏转偏轴。中间段14的远侧为远侧段17,远侧段17承载适于消融和冲洗的远侧尖端电极T和多个环电极R。
在图4A、4B和4C描绘的实施例中,导管主体12包括具有单个轴向或中央管腔18的细长管状构造。导管主体12是柔性的,即可弯曲的,但沿其长度基本上是不可压缩的。导管主体12可为任何合适的构造,并且可由任何合适的材料制成。目前优选的构造包括由聚氨酯或PEBAX制成的外壁 30。外壁30包括由不锈钢等(如本领域通常所知的)制成的嵌入式编织网,以增大导管主体12的扭转刚度,以使得在旋转控制手柄16时中间段 14和远侧段17将以相应的方式旋转。
导管主体12的外径并非决定性因素,但优选地为不大于约8F(french 弗伦奇),更优选地不大于约7F。同样,外壁30的厚度也不是决定性因素,但要足够薄,以使得中央管腔18可容纳任何所需的线、电缆和/或管。外壁30的内表面可衬有加强管31,以得到改善的扭转稳定性。加强管31 的外径与外壁30的内径相比大致相同或稍小。加强管31可由诸如聚酰亚胺的任何合适材料制成,该材料提供非常好的刚度且在体温下不软化。
可偏转中间段14包括具有多个管腔的一短截配管15,每个管腔被延伸通过中间段的各个部件占据。在图示实施例中,存在五个管腔33、34、 35、36和37,如图4C中最清楚看出的。用于每个电极的引线/热电偶对 40、41穿过在图示实施例中同轴的第一管腔33。提供了不导电保护鞘管 42。同轴冲洗配管38穿过在图示实施例中偏轴的第二管腔34。为了至少单向偏转,第一拉线44a穿过第三偏轴管腔35。用于定位传感器组件(包括位于远侧段17上的多个单轴传感器(SAS))的电缆46穿过在图示实施例中偏轴的第四管腔36。为了双向偏转,第二拉线44穿过第五偏轴管腔37。
同轴冲洗配管38限定多个同轴管腔。在所公开的实施例中,至少存在彼此互斥的内管腔39a和外管腔39b,用于将流体输送到电极(或第一组电极)和另一电极(或第二组电极)。也就是说,配管38在导管内提供至少两个平行、专用、单独且隔离的流动通道。流体可被两个流动通道同时输送,或者流体可在一个流动通道而不是另一个流动通道中输送,反之亦然。
中间段14的多管腔配管15由比导管主体12优选地更柔韧的合适的无毒材料制成。合适的材料是编织聚氨酯或PEBAX,即具有嵌入的编织不锈钢或类似材料的网的聚氨酯或PEBAX。每个管腔的数量和尺寸不是决定性因素,前提是有足够空间来容纳延伸通过其中的部件。除了用于拉线44a、 44b的管腔35、37的位置之外,每个管腔的位置也不是决定性因素。管腔 35、37应为偏轴的,并且在直径上彼此相对以用于沿平面的双向偏转。
导管的可用长度,即可插入体内的部分,可根据需要变化。优选地,可用长度在约110cm至约120cm的范围内。中间段14的长度是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。
图4A和图4B中示出了将导管主体12附接到中间段14上的优选方式。中间段14的近端包括内周凹口,该内周凹口接纳导管主体12的加强管 31的远端的外表面。中间段14和导管主体12通过例如聚氨酯的胶等附接。如果需要,可以在导管主体12内的加强管31远端和中间段14近端之间设置垫片(未示出),以在导管主体12和中间段的接合部处提供柔韧性的过渡,这允许接合部平滑地弯曲而不折叠或扭结。这样的垫片的例子在美国专利No.5,964,757中有更详细的描述,该专利的公开内容以引用的方式并入本文。
参照图5,中间段14远侧为包括多管腔配管50的远侧段17,在多管腔配管50上安装有远侧尖端电极T和多个环电极R1-RN,例如范围在约3个至9个之间的环电极。在所公开的实施例中,存在五个环电极。配管50可由诸如聚氨酯或PEBAX的任何生物相容性塑料制成。在图6A、6B和6C 的图示实施例中,配管50具有三个管腔51、52和53。用于尖端电极的引线/热电偶对40、41穿过第一同轴管腔51,第一同轴管腔51与中间段14的第一管腔33大体上轴向对齐。与中间段的第二管腔34大体上轴向对齐的第二偏轴管腔52接纳同轴冲洗配管43的远端。管腔52的尺寸适于与配管43 远端形成不透流体的密封,以便流体向远侧直接流入管腔52。如图6C所示,在每个环电极R下面的配管50的侧壁中形成径向开口55,以使得流体从同轴冲洗配管43的外管腔39b流入配管50的管腔52并进入环电极R1- RN,如箭头57所示。内管腔39a未破裂,以使得流体继续朝导管远端流动。图7详细示出了合适的冲洗环电极。
参照图6A、6B,环电极R适于消融和冲洗。环电极为大致圆柱形的,并且长度大于其直径。环电极具有类似圆筒的侧剖面,并具有在相对的端部 66之间径向凸出的侧壁60。弯曲的过渡区域67设置在侧壁60和端部66之间以提供没有拐角或锋利边缘的无创伤轮廓。
参照图6C,在远侧段17的配管50的外部周围存在贮存器或环形间隙 G。间隙G提供了经由小孔62从第二管腔52到环电极外部的改善的流体分布。配管50中的开口55的尺寸随着沿远侧段17的长度的位置而变化。为了实现最佳流动,开口55沿远侧段17越向远侧,在每个环电极下面的开口和/或多个开口55的尺寸或横截面越大。
小孔62以包括轴向偏移行的预定图案布置在侧壁60中。这些小孔面向外,从而促使径向流动(参见箭头63)。在弯曲的过渡区域67内部或附近也设有小孔,以促使在轴向上更大的流量(参见箭头64)。此外,这些小孔尤其是能有效最小化弯曲的过渡区域67处或附近的烧焦和凝结,由于电极轮廓中的过渡部,这些区域可能是由更高电流密度导致的“热点”。就这一点而言,小孔62的数量和/或截面在弯曲的过渡区域67处或附近比在电极的侧壁60中更大,以便在弯曲的过渡区域中提供更多冷却。其他合适的环电极在美国专利申请公布No.US2010/0168548A1和提交于2011年6 月30日的美国专利申请No,13/174,742中有所描述,这两份专利的全部内容据此以引用方式并入本文中。
在远侧段17的配管50的远端上的尖端电极T具有外壳70,外壳70具有限定具有开放的近端73的内部腔体72的U形截面,近端73由塞74密封以在尖端电极中形成充气室75。在外壳的径向壁中形成多个冲洗小孔77,以允许在充气室中收集的流体流出到尖端电极的外部(参见箭头79)。
形成于塞73中的轴向通道80接纳同轴冲洗配管43的内管腔39a。如图8所示,外管腔39b的远端终止于中间段14的配管15与远侧段17的配管50的接合部的远侧较短距离处,以使得在外管腔39b中输送的流体直接流入配管50的第二管腔52。可使用密封剂在外管腔39b的远端周围形成不透流体的密封。
在图示实施例中,内管腔39a延伸通过通道80并终止于塞74的远侧面处或附近,以使得穿过内管腔39a的流体进给到充气室75中。在通道80中的内管腔39a的远端周围可使用密封剂。塞74的尺寸适于在开口端73处形成不透流体的密封。塞74也具有形成于近侧面上的盲孔78,用于接纳引线/ 热电偶对40、41,以便与尖端电极电导通。为此,塞74和外壳70均由导电材料制成,以使得电能可在引线和外壳之间流过。与环电极类似的,尖端电极可由任何合适的贵金属制成,例如铂或金,优选铂和铱或金和铂的组合。
根据本发明的特征,导管10适于为不同电极或不同组电极提供单独且专用的冲洗流动通道。电极间的选择和划分可基于电极的位置(例如,远侧或近侧)和/或其类型或功能(例如,尖端/环、单极/双极、或局灶性/连接)进行。在公开的实施例中,电极间的划分在远侧尖端电极和所有近侧环电极之间进行,使得第一流动通道专用于为尖端电极而不是环电极供应,并且第二流动通道专用于为所有环电极而不是尖端电极供应。本领域的普通技术人员应理解,划分也可以仅基于携带具有相同类型或功能的多个电极的导管的远侧段之间的位置进行。例如,在仅具有环电极的远侧段上,第一流动通道可专用于为环电极的近侧部分供应,并且第二流动通道可专用于为环电极的远侧部分供应。
参照图2、4A和4B,在所公开的实施例中,同轴冲洗配管38从远侧段17的配管50的第二管腔52、中间段14的配管15的第二管腔34、导管主体12的中央管腔18、以及控制手柄16延伸。根据本发明的特征,同轴冲洗配管38的近端向近侧延伸经过控制手柄16并终止于控制进入导管的流体流的流量平衡阀90中。
流量平衡阀90的实施例在图9、9A-9D和10中详细示出。该阀门具有两件式大致圆柱形主体92和柱塞组件94。主体包括近侧主体部分92a和远侧主体部分92b。近侧部分92a具有开放的外周端93,外周端93接纳远侧部分的开放的内周端95。当接合时,部分92a、92b被构造成限定扩大的内部流动腔体96,流动腔体96连接形成于近侧部分92a中的入口开口97和形成于远侧部分92b中的出口开口92b。入口开口和出口开口沿主体92的纵向轴线100轴向对齐。在入口开口和腔体之间以及在腔体和出口开口之间为漏斗形过渡区域101、102,在这里,穿过其中的流动通道的截面迅速变化。从入口开口到腔体,截面迅速增加。从腔体到出口开口,截面迅速减小。
柱塞组件94与纵向轴线100轴向对齐。柱塞组件包括位于近侧部分 92a中的柱塞头105和固定地安装在远侧部分92b中的基部106。在柱塞头和基部之间延伸着具有预定刚度或弹簧常数的弹性或弹簧构件107(例如卷簧)。弹簧构件的相对端锚固在轴向对齐的杆凸起108周围,杆凸起108形成于柱塞头105的远侧面和基部106的近侧面上。与轴线100对齐的是分别形成于柱塞头和基部中的轴向通孔104和109,用于接纳延伸通过连接柱塞头和基部的弹簧构件107的内管腔39a。
入口开口和出口开口限定通过阀门的流动方向(例如,如图9所示从左向右)。因此,出口开口在入口开口的下游,并且入口开口在出口开口的上游。应当理解,阀门的其他部件可以用该流动方向类似地描述。
柱塞组件94被构造成在柱塞头(图9)上接受大致轴向力(箭头 109),该力压缩弹簧构件107并使柱塞头105朝向基部106且远离入口过渡区域101的方向位移(图10)。基部106固定地定位在远侧部分92b中且贴着凸缘110楔入以防止相对于主体的远侧位移。柱塞头具有大致凸形的轮廓,用于在其近侧表面上径向且轴向地分散流体到腔体96中,以在柱塞头105的周边115周围限定大致环形的流动区域112。在所公开的实施例中,柱塞头为圆锥形,但其可以是多种形状,包括球形或甚至平面的。
入口过渡区域101的尺寸和形状大致对应于柱塞头105的形状和尺寸,以促进流动并最小化流动区域112中的湍流。因此,入口过渡区域具有大致凹形的轮廓。然而,优选的是尺寸和形状不严格对应,以使得通过入口过渡区域的流动区域112绝不会被抵靠区域101的柱塞头105完全闭塞。也就是说,即使所有电极都不活动,通常也希望在消融术期间通过电极维持至少最小的流量,以冲洗电极并使其没有碎屑。为此,可以在柱塞头105的近侧表面119上形成通道或凹槽117(图11)以改变或增加从入口开口97到腔体96的流量分布。
入口开口96被构造成接纳鲁尔插头128,鲁尔插头128连接到从流体源FS延伸的流体配管130,如图2所示。因此,流体由冲洗泵27从流体源 FS泵送进入流体配管130、鲁尔插头128和入口开口97,并在入口开口97 处流到柱塞头105上。有利地,进入阀门90的一部分流体进入内管腔39a (箭头132),并且一部分由柱塞头105转向进入腔体96(箭头112)。如图9C所示,基部形成有一个或多个通孔140,以使得分散的流体能穿过基部106并经由出口开口98离开腔体96。
当由泵27产生的进入阀门90的流量等于或小于预定流量时,流体仅仅进入内管腔39a或绕过柱塞头105而不移动柱塞头。然而,当流量大于预定流量时,不但进入内管腔39a的流量增加,而且流体施加足以克服弹簧构件107和朝基部106压下柱塞头105的力,从而将柱塞头和入口过渡区域之间的空间间距从S1增加至S2(如图9A中更好示出的)。柱塞头105周围的环形流动区域112越大,通过腔体96且因而通过出口开口98进入外管腔 39b的流量越大。就这一点而言,柱塞头可以在内管腔39a的外表面上自由滑动,而不影响柱塞头朝基部的压缩。因此,还应理解,内管腔39a可能需要具有一定刚度的结构,以使柱塞头和基部之间保持轴向对齐。例如,相比延伸通过控制手柄的内管腔39a的部分或导管的任何其他部分,包括导管主体12、中间段14和远侧段17,延伸通过阀门的内管腔39a的部分可由更硬的材料制成。
阀门90因此在入口开口101和出口开口102之间提供两个单独的流动通道。无阻碍部分进入限定第一流动通道的管腔39a。剩余部分由柱塞头 105朝流动区域112转向并进入内部腔体,在这里,其经由通孔140朝出口开口经过基部106。当柱塞头在从流体冲击到其近侧表面上的更大压力下发生位移时,第二流动通道的流量/流量随着流动区域112扩大和更多流体进入腔体而相应地变化。
在所公开的实施例中,冲洗流体通过伸入尖端电极的内管腔39a输送到尖端电极,并且冲洗流体通过外管腔39b输送到环电极,而外管腔39b终止于远侧段的配管50的第二管腔52中。至少具有管腔39a和39b的同轴冲洗配管38延伸通过中间段的配管15的第二管腔32、导管主体12的中央管腔18、以及控制手柄16。
每条电极引线的近端在控制手柄16的远端处电连接到合适的连接器以连接到RF发生器11。为每个电极提供一对线40、41。在所公开的实施例中,线对的线40为铜线,例如“40”号铜线,而线41为康铜线。除了在其远端处扭在一起之外,每个线对的线彼此电绝缘。通过将线对穿过形成于侧壁中的孔140进给到远侧段17的配管50的第一管腔51中,并且焊接到相应的环电极(参见图6B),实现与相应环电极R的附接。用于每个电极 (环电极和尖端电极)的线对从控制手柄16向远侧延伸通过导管主体12的中央管腔18、中间段14的第一管腔33、以及远侧段17的第一管腔51。RF 能量经由线对的线40输送到电极。然而,如本领域的普通技术人员所理解,包括其相应康铜线的线对也可充当感测每个电极的温度的温度传感器或热电偶。
所有线对穿过与其呈包围关系的公共的不导电保护鞘管42(图4C),该鞘管可由诸如聚酰亚胺的任何合适的材料制成。鞘管42从控制手柄16、导管主体12、中间段14延伸,并且终止于恰好远离远侧段17的近端处。远端通过诸如聚氨酯胶的胶等锚固在第一管腔51中。
提供一对偏转拉线44a、44b用于中间轴14的偏转。拉线44a、44b延伸通过导管主体12的中央管腔18并且分别通过中间段14的第三管腔35和第六管腔38中的相应一个。拉线在其近端锚固在控制手柄16中,并且在其远端借助于T形条142锚固到中间段14远端或附近的位置处(图4C),T 形条142通过诸如聚氨酯的合适的材料103固定到配管15的侧壁,如美国专利No.6,371,955中大致描述的,该专利的全部公开内容以引用方式并入本文中。拉线由任何合适的金属制成,诸如不锈钢或镍钛诺,并优选地用等材料涂覆。涂层使拉线具有润滑性。例如,每根拉线的直径优选在约0.006至约0.010英寸的范围内。
如图4A和4B中所见,每根拉线具有与其呈包围关系的相应的压缩弹簧144。每个压缩弹簧144从导管主体12的近端延伸至中间段14的近端处或附近以允许偏转。压缩弹簧由任何合适的金属制成,优选地为不锈钢,并且均自身紧密地缠绕,以提供柔韧性,即弯曲性,但可抗压缩。压缩弹簧的内径优选稍大于拉线的直径。拉线上的涂层使得它能在压缩弹簧内自由滑动。在导管主体12内部,压缩弹簧的外表面覆盖有柔韧的不导电鞘管152,例如由聚酰亚胺配管制成的鞘管。压缩弹簧在其近端处通过近侧胶接头锚固到导管主体12的外壁30并通过远侧胶接头锚固到中间段14。
在中间段14的第三管腔35和第五管腔37内,拉线44a、44b延伸通过塑料优选拉线鞘管146(图4B),鞘管防止在中间段14被偏转时拉线切入中间段14的配管15的壁中。
通过适当操纵控制手柄16实现拉线44a、44b相对于导管主体12的纵向移动,以便双向偏转。偏转旋钮150(图1)设置在手柄上,其可以在顺时针或逆时针方向上枢转以在相同方向上偏转。用于操纵不止一根线的合适的控制手柄例如在美国专利No.6,468,260、6,500,167和6,522,933以及提交于2010年12月3日的美国专利申请No.12/960,286中有所描述,这些专利的全部公开内容以引用方式并入本文中。
在一个实施例中,定位传感器48包括多个单轴传感器(“SAS”),这些传感器承载于延伸通过远侧段17的第三管腔46的电缆46上(图4C),其中每个SAS占据沿着远侧段长度的已知或预定位置。电缆46从远侧段17 向近侧延伸通过中间段14的第四管腔36(图6)、导管主体12的中央管腔 18并进入控制手柄16中。每个SAS可定位成具有分离相邻SAS的已知并相等的间距。在所公开的实施例中,电缆承载位于最远侧环电极(图 6A)、最近侧环电极和中间环电极下面的三个SAS,用于感测远侧段的位置和/或定位。SAS使得远侧段能够在由Biosense Webster,Inc.制造和销售的标测系统下进行观察,该系统包括CARTO、CARTO XP和NOGA标测系统。合适的SAS在提交于2010年12月30日的美国专利申请No. 12/982,765中有所描述,该专利的全部公开内容以引用方式并入本文中。
图12是根据本发明实施例的用于消融患者228心脏226中的组织的系统S的示意性说明图。操作者222(如心脏病医生)通过患者的血管系统插入导管10,使得导管的远端进入患者心室内。操作者推进导管,使得导管远侧段17在所需的一个或多个位置处接合心内膜组织,如图5所示。用合适的连接器将导管10在其近端处连接到控制台230。控制台包括RF发生器 236,其通过导管远侧段的尖端电极和环电极施加RF能量,以便消融由远侧段接触的组织。
响应于来自RF发生器236的表示导管上每个电极的激励状态的信号,具有泵头的冲洗泵240适于以不同流量向导管提供冲洗流体,以便向电极提供合适的冲洗流体。由于同轴冲洗配管38用主动平衡两个流的阀门90限定至少两个单独的流体流动通道,因此以不同的流量并优选地根据电极的激励状态为所选的(多个)电极或多组电极供应流体。
图12是对于系统S的一个实施例的不同操作条件下的样品流速表,说明如下:
条件1:在维持流量期间,冲洗泵被设为8mL/min的流量。当流体流进入阀门时,其被导入供应尖端电极和环电极的内管腔39a中。
条件2:在局灶性消融期间,冲洗泵被设为21mL/min的流量。柱塞头两端的压差不足以使柱塞头发生位移。流的大部分被导向至供应尖端电极的内管腔39a 以允许大约15mL/min的流量,同时环电极被供以维持流量。
条件3:在线性消融期间,冲洗泵被设为33mL/min的流量。柱塞头两端的压差足够高,可使柱塞头发生位移,从而允许到环电极的流量增加。
在图示的实施例中,系统S使用磁性位置感测来确定导管的远侧组件在心脏内的位置坐标。为了确定位置坐标,控制台230中的驱动电路234驱动磁场发生器232,以在患者体内产生磁场。磁场发生器通常包括线圈,其放置在患者躯干下面的已知体外位置处。这些线圈在包含心脏的预定工作空间内产生磁场。在导管的远侧段内的诸如SAS的一个或多个磁场传感器响应这些磁场而产生电信号。控制台230处理这些信号,以便确定导管的远侧段17的坐标的位置(定位和/或取向)坐标。控制台可以在驱动显示器238 时使用坐标,使其显示导管的位置和状态。这种位置感测和处理方法在例如 PCT国际公布WO96/05768(该专利的全部公开内容以引用方式并入本文) 中有详细描述,并且在加利福尼亚州钻石吧(Diamond Bar,California)的 Biosense Webster Inc.制造的CARTO系统中实现。
操作者可以首先将鞘管经皮穿过脉管系统并通过上腔静脉进入心脏。然后,将导管插入鞘管,直到导管的远侧段17延伸经过鞘管的远端并被暴露出来以与心脏中的靶组织接触。操作者可以旋转控制手柄和/或使用控制手柄16的偏转旋钮150,以便在朝靶组织引导远侧段17的过程中操纵导管。操作者可以利用上述位置感测方法以及如在显示器238上显示的预采集的心脏标测图或图像来进行这种对齐。作为另外一种选择或除此之外,可以在荧光镜或其他可视化装置的帮助下进行该对齐操作。
参照图5,导管10很适于形成线性或连续损伤,诸如在左心房中的“顶线”。例如,当远侧段17的尖端电极T和环电极R1-RN被定位成与靶组织接触时,尖端电极T和环电极R被激励(后者作为单极电极被激励) 以消融和形成多个局灶性损伤110(实线)。与RF发生器连通并响应于RF 发生器,冲洗泵启动泵头的马达控制以便在所选流量下向尖端电极和环电极供应到达阀门90的流体,该阀门有效分隔成具有离开阀门的不同流量的至少两个单独的流动通道。例如,当只有尖端电极被激励(例如用于局灶性单极消融)并且环电极不活动时,RF发生器236向泵240发送信号,以便在避免柱塞头发生位移的适当的所选流量下向阀门90泵送流体,以使得最少的流围绕柱塞头朝外管腔39b流过以仅仅冲刷环电极,同时更大的流进入内管腔39a以冷却尖端电极。最少的流有利地使作用于患者的流体负荷最小化。
相比之下,当尖端电极和环电极被激励(例如,用于借助单极和双极消融进行线性消融)时,RF发生器向泵发送信号,以便在将向远侧位移柱塞头105的更大的所选流量下向阀门泵送流体,以使得更大的流围绕柱塞头朝外管腔39b流过,以提供用于冷却环电极的更多流体。更大的流可以进入内管腔39a以提供用于冷却尖端电极的流体。阀门由此作用于以预定流量进入的流体以分裂和平衡流体,以使得流体在两个不同的分开并独立的通道中以两种不同的流量离开。
有利地,当通过激励为单极电极的电极由局灶性损伤110(实线)然后通过激励为双极电极的电极由连接损伤灶112(虚线)形成连续损伤时,导管10保持相同定位并且不需要被拖动或再定位。由于导管不需要再定位,减少了消融手术时间并提高了临床疗效。
如果需要修饰断开的或不完整的损伤线,则可以再定位导管,使得尖端电极T形成额外的局灶性损伤以完成线性或连续损伤。在仅激励尖端电极的情况下,冲洗泵向泵头的马达控制发送信号以减小流量,以使得柱塞头不被压下,并且环电极仅经由外管腔39b接纳用于冲刷目的的最少的流,同时尖端电极经由内管腔39a接纳用于冷却的足够的流。
尽管图12示出了具体的系统构型,但也可在本发明的可供选择的实施例中使用其他系统构型。例如,可以用其他类型的位置传感器实施下文描述的方法,诸如阻抗型或超声位置传感器。如本文所用,术语“位置传感器”是指安装在导管之上或之内的元件,该元件使控制台接收指示元件坐标的信号。因而该位置传感器可包括导管中的接收器,其根据传感器接收到的能量产生位置信号至控制器;或传感器可以包括发射器,其发射探针外部的接收器可感测的能量。此外,类似地,实施下文描述的方法时,不仅可以使用导管,而且可以使用其他类型的探针,既可以在心脏中、又可以在其他身体器官及区域中进行标测和测量应用。
已结合本发明的当前的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。在一个实施例中公开的特征或结构可根据需要或合适地代替任何其他实施例的其他特征或除任何其他实施例的其他特征之外被并入。本领域内的普通技术人员将了解,附图未必按比例绘制。因此,以上描述不应视为仅与所描述的和附图所示的精确结构有关,而应视为符合所附的具有最全面和合理范围的权利要求书,并作为权利要求书的支持。
Claims (19)
1.一种导管,包括:
细长主体;
远侧段,其至少具有第一电极和第二电极,每个电极适于冲洗;
控制手柄,其位于所述细长主体的近侧;
同轴冲洗配管,其至少具有内管腔和外管腔,所述内管腔专用于输送流体到所述第一电极,并且所述外管腔专用于输送流体到所述第二电极;以及
共用阀门,其包括可动构件,入口开口和出口开口,所述出口开口流体连接到所述同轴冲洗配管的所述内管腔和所述外管腔两者,所述共用阀门具有在所述入口开口和所述出口开口之间独立的第一流体流动通道和第二流体流动通道,所述第二流体流动通道绕所述可动构件的外表面延伸并进入所述外管腔,所述第一流体流动通道穿过所述可动构件延伸并进入所述内管腔,以及所述可动构件构造为响应于阈值流体力自动移动由此扩大或扩张所述第二流体流动通道。
2.根据权利要求1所述的导管,其中所述第一电极为尖端电极,并且所述第二电极为环电极。
3.根据权利要求1所述的导管,其中所述内管腔限定第一流体流动通道,并且所述外管腔限定第二流体流动通道,而所述第一和第二流体流动通道在所述导管内彼此隔离。
4.根据权利要求3所述的导管,包括至少两个环电极,并且所述第二流体流动通道被构造成输送流体到所述至少两个环电极。
5.一种与导管冲洗管一起使用的阀门,包括:
主体,其限定入口开口、出口开口和连接所述入口开口与所述出口开口的内部腔体,所述入口开口适于以预定的流量接纳流体流;
柱塞组件,其位于所述内部腔体中,所述柱塞组件具有:
柱塞头;
基部;
弹簧构件,其在相对于所述入口开口的预定位置处从所述基部支撑所述柱塞头;和
第一管腔,其穿过所述柱塞头和所述基部,
其中,所述主体限定第一和第二流体流动通道,所述第一流体流动通道包括所述第一管腔并且没有所述内部腔体,并且所述第二流体流动通道包括所述内部腔体并且没有所述第一管腔,所述第一流体流动通道接纳经由所述入口开口进入所述阀门的流的第一部分,所述第二流体流动通道接纳经由所述入口开口进入所述阀门的所述流的第二部分,
其中,所述弹簧构件适于在所述流量超过阈值流量时允许所述柱塞头相对于所述入口开口发生位移,以改变由所述第一和第二流体流动通道接纳的所述流的所述部分中的至少一者。
6.根据权利要求5所述的阀门,其中所述柱塞头更远离所述入口开口的位移增加由所述第二流体流动通道接纳的所述流。
7.根据权利要求5所述的阀门,其中所述柱塞头更靠近所述入口开口的移动减少由所述第二流体流动通道接纳的所述流。
8.根据权利要求5所述的阀门,其中所述柱塞头具有大致凸形的轮廓。
9.根据权利要求5所述的阀门,还包括外管腔,所述外管腔围绕延伸通过所述出口开口的所述第一管腔的一部分。
10.根据权利要求5所述的阀门,其中所述第一流体流动通道包括所述入口开口和所述第一管腔。
11.根据权利要求5所述的阀门,其中所述第二流体流动通道包括所述入口开口、经过所述柱塞头和所述基部的所述内部腔体、以及所述出口开口。
12.根据权利要求5所述的阀门,其中所述主体具有纵向轴线,并且所述入口开口和所述出口开口与所述纵向轴线大致对齐。
13.根据权利要求5所述的阀门,其中所述主体具有纵向轴线,并且所述第一管腔与所述纵向轴线大致对齐。
14.根据权利要求5所述的阀门,其中所述柱塞头具有大致凸形的构型,并且所述入口开口具有大致凹形的构型。
15.根据权利要求5所述的阀门,其中所述弹簧构件为卷簧。
16.根据权利要求5所述的阀门,其中所述弹簧构件在所述柱塞头和所述基部之间延伸。
17.根据权利要求5所述的阀门,其中所述入口开口和所述出口开口限定通过所述阀门的流动方向,并且所述柱塞头相对于所述流动方向在所述基部的上游。
18.一种用于消融的系统,包括:
导管,其适于消融,至少具有第一电极和第二电极以及同轴冲洗配管,所述同轴冲洗配管被构造成具有在所述导管内的单独的内管腔和外管腔以用于将流体输送到每个电极;
消融能发生器,其被构造成选择性地激励所述第一和第二电极;
冲洗泵,其响应于来自所述消融能发生器的指示至少一个电极的激励状态的信号;
流体源,和
共用阀门,其被构造成接纳来自所述流体源的流体以输送到所述同轴冲洗配管,所述共用阀门包括可动构件,入口开口和出口开口,所述出口开口流体连接到所述同轴冲洗配管的所述内管腔和所述外管腔两者,所述共用阀具有在所述入口开口和所述出口开口之间独立的第一流体流动通道和第二流体流动通道,所述第二流体流动通道绕所述可动构件的外表面延伸并进入所述外管腔,所述第一流体流动通道穿过所述可动构件延伸并进入所述内管腔,以及所述可动构件构造为响应于阈值流体力自动移动由此扩大或扩张所述第二流体流动通道;
其中所述冲洗泵适于根据来自消融能发生器的所述信号将流体以所选流量泵送到所述导管,并且
其中所述共用阀门具有适于以两种不同的流量输出两个单独的流体流的柱塞组件。
19.根据权利要求18所述的系统,其中所述导管具有至少一个尖端电极和一个环电极,其中来自所述共用阀门的一个流体流将流体供应至所述尖端电极,并且来自所述共用阀门的另一流体流将流体供应至所述环电极。
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JP6185128B2 (ja) | 2017-08-23 |
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CN102895027A (zh) | 2013-01-30 |
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IL221151A (en) | 2017-04-30 |
US20200383727A1 (en) | 2020-12-10 |
US20170215956A1 (en) | 2017-08-03 |
AU2012206981A1 (en) | 2013-02-14 |
CA2783922A1 (en) | 2013-01-30 |
AU2012206981B2 (en) | 2016-01-14 |
IL251542B (en) | 2018-06-28 |
EP2656808A1 (en) | 2013-10-30 |
IL251542A0 (en) | 2017-05-29 |
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