CN101534737A - 具有一个或多个电极的消融导管装置 - Google Patents

具有一个或多个电极的消融导管装置 Download PDF

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CN101534737A
CN101534737A CNA2007800389107A CN200780038910A CN101534737A CN 101534737 A CN101534737 A CN 101534737A CN A2007800389107 A CNA2007800389107 A CN A2007800389107A CN 200780038910 A CN200780038910 A CN 200780038910A CN 101534737 A CN101534737 A CN 101534737A
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CN101534737B (zh
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西奥多·C·奥士比
乔治·L·梁
沈国镇
朱彼得
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MedWaves Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/0091Handpieces of the surgical instrument or device
    • A61B2018/00916Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/0091Handpieces of the surgical instrument or device
    • A61B2018/00916Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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    • A61B2018/183Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves characterised by the type of antenna

Abstract

射频(RF)消融导管具有柔性的远端部分,使得它能够被偏转,以将设置在远端部分内的天线定位到与将被治疗的组织位置邻近。至少一个电导体被连接至天线,穿过导管,延伸到导管的近端,到达连接器,连接器位于导管的近端处并用于连接至RF天线的电源。至少一个电极被设置在导管的远端部分,并被电连接至用于连接至监控器的近端连接器。电极由柔性的导电材料(例如,导电聚合物材料)形成。电极可以是心电图(ECG)电极。

Description

具有一个或多个电极的消融导管装置
背景技术
1.技术领域
本发明通常涉及用于消融生物组织的医疗设备,更具体地涉及合并了一个或多个电极(例如,心电图(ECG)电极)的消融导管装置。
2.背景技术
消融导管将能量应用到需要消融的生物组织位置。这些导管可使用各种能量形式,例如,射频、超声波、激光、低温(cryogenic)等。射频(“RF”)消融导管通常工作在微波频率范围内并用于治疗目的消除和消融生物组织。在一个应用中,微波消融导管用于对造成不规则心跳或心律不齐的心脏组织进行消融,避免进行更危险和更侵入性的开心手术。在微波消融过程中,导管天线通过通向心房的血管。在心房内,天线被定位在需要消融的期望位置处。心内电图用于识别需要被消融的心脏组织位置处的传导通路(conductive pathway)。
现有技术的消融导管已经装配有由导电材料制成的两个或两个以上的心电图(“ECG”)电极环或电极钮,为期望的消融位置的识别提供必要的输出信号。传统上,用于此目的的所有导管安装有金属电极而不考虑能量形式(RF、超声波、激光、低温等)。将金属电极安装在微波天线上具有特殊的挑战性。错误地安装裸露的金属电极可能吸收消融能量并且变热。热的电极可能对心脏或其它生物组织或器官有不利的影响,例如,形成血块、粘附到组织上以及组织碳化。裸露的金属电极还可能阻止能量的有效传递以及阻碍消融效率。另外,当金属电极弯曲的时候,金属电极可从导管分离,从而产生不准确或丢失信号。
因此,需要一种有效的系统和方法,提供来自消融导管装置的ECG输出信号。
发明内容
本发明的消融导管系统包括:细长导管,适用于插入患者的身体血管内,所述导管具有近端部分和远端部分,所述近端部分适用于定位为与需要治疗的生物组织位置邻近,所述远端部分具有与控制消融过程的控制单元连接的连接器;天线,被设置在所述导管的所述远端部分,用于为组织消融提供输出能量;一对导体,从所述近端部分延伸通过所述导管并连接至所述天线,用于从所述控制单元的电源给所述天线供电;以及至少一个电极,由设置在所述天线的所述远端部分的柔性导电材料形成,并连接至位于所述导管的所述近端部分处且给所述控制单元提供输出信号的所述连接器。柔性导电材料是至少基本非金属的。
一个或多个电极可设置在所述导管的所述远端部分处。在一个实施方式中,电极是由亲水性的导电聚合物材料形成,用于改进可湿润性。两个隔开的电极环安装在阴极的外表面上,或者嵌入阴极的外表面中。可选地,可设置一个电极环,其它电极可以是位于所述导管的所述远端处的导电聚合物材料的顶端。在可选的实施方式中,导电聚合物材料层和非导电聚合物材料层可设置在所述导管的所述远端部分的特定位置处,以产生多个工作电极。在每种情况中,电极输出信号能够被连接至位于控制单元中、用于记录系统输入的适当电极,或者连接至单独的心电图单元以提供心内信号映射。
所述配置避免了金属电极的问题,还提供由柔性聚合物材料形成的电极,当导管被塑性或弯曲以通过身体血管的通道时,所述柔性聚合物材料形成的电极能够容易地与所述导管的所述远端部分一起弯曲。
在阅读如下的详细描述和附图之后,本发明的其它特征和优点对本领域的普通技术人员来说将变得更加显而易见。
附图说明
通过对附图的研究,可部分地获取本发明的详细内容,例如,它的结构和操作,附图中相同的标号表示相同的部件,其中:
图1A和1B分别是在直线构造和弯曲构造中的、根据一个实施方式的可塑形RF消融导管的侧面正视图;
图2A和2B是具有不同于图1的操纵机构的、根据另一实施方式的可塑形RF消融导管的侧面正视图;
图3A和3B分别是在直线构造和弯曲构造中的、图1或2的导管的末端的远端部分的横截面视图;
图4是合并了电极的可塑形或可弯曲RF消融导管的一个实施方式的末端或远端部分的横截面视图;
图5是根据另一实施方式的、具有修改电极配置的可塑形或可弯曲RF消融导管的末端或远端部分的横截面视图;
图6是具有另一电极配置的可塑形或可弯曲RF消融导管的末端或远端部分的横截面视图;
图7是根据另一实施方式的、具有修改电极配置的可塑形或可弯曲RF消融导管的末端或远端部分的横截面视图;以及
图8是根据另一实施方式的、具有修改电极的可塑形或可弯曲RF消融电极的末端或远端部分的横截面视图。
具体实施方式
本文公开的几个实施方式提供了通过可弯曲射频(RF)导管对身体区域(例如,心脏、肝脏等)内的生物组织进行消融的系统和方法。该导管在其远端处配置有柔性导电材料(例如,导电聚合物)的电极,将例如心内心电图(“ECG”)信号的输出信号提供给控制单元,以允许医生在组织消融之前和之后获得组织接近性和导电信息,还在消融过程中提供其它反馈。
在阅读本说明书之后,如何在各种可选实施方式和可选应用中实现本发明,对本领域技术人员来说是显而易见的。然而,尽管本发明的各种实施方式仅通过实施例的方式给出,但是不限于此。因此,各种可选实施方式的详细描述不应该构成对权利要求中阐明的本发明的范围或广度的限制。
图1A和1B图示了一个实施方式的射频(“RF”)消融导管系统100,包括可塑形导管装置100,其适用于插入患者的身体血管内,且合并了用于将电磁能量传递给治疗位置的RF天线,更详细的内容如下文所述。
导管装置100具有柔性、细长的管状主体120,管状主体120具有近端部分130和远端或末端部分140。位于主体的近端部分的是由执行器200启动的手柄盘160,手柄盘160包含用于主体的操纵和定位控制装置(未示出)。在图1A和1B的实施方式中,通过在轴向方向向前和向后滑动执行器,启动导管主体的末端部分使其在图1A的直线构造与图1B的弯曲构造之间弯曲。在图2A和2B的修改的实施方式中,通过旋转执行器或环220使末端部分在直线构造与弯曲构造之间弯曲。用于控制导管主体120的末端部分弯曲的适当机构在Ormsby等人的第7,004,938号美国专利中有详细描述,该专利的内容通过引用并入本文。然而,可理解,任何适当的机构可合并到导管装置中,以在末端部分在身体血管、器官或腔内移动时控制末端部分的弯曲或操纵。
在导管装置的近端处设置了耦合或电连接器170,用于将导管连接至控制单元等,这些控制单元包含用于在消融过程中将功率提供给天线的一个或多个电子器件(例如,RF发生器和控制器(未示出))。适当的信号控制单元在消融导管领域是众所周知的,因此在此不做详细描述。
按需调整导管主体的尺寸以适合于特定的医疗过程在医疗领域中是众所周知的。在一个实施方式中,导管用于消融心脏组织。然而,导管可用于消融位于体内和体外的不同器官内的其它类型的身体组织。导管装置的管状主体120可通常由与身体血管环境生物相容的聚合物材料构建。这些材料的实施例包括具有不同程度的辐射不透性、硬度和弹性的热塑性弹性体材料,例如来自Autochem Germany的Pebax
Figure A200780038910D0010140919QIETU
以及聚乙烯、聚亚胺酯、聚酯、聚酰亚胺和聚酰胺等。
导管的管状主体可以由一个或多个前述材料或等同材料形成的多个段组成,以使得导管主体120接近其远端时逐渐变得柔性。这些段可通过热结合、对接或粘结连接在一起。可以在管状主体的表面设置编织加强层以达到导管期望的硬度和抗扭强度级别,以在患者的身体血管内前进并通过患者的身体血管,同时仍然使远端部分在需要的时候能够弯曲。远端部分140可以由比身体的其余部分更软的聚合物复合材料构成,具有很少或没有编织层或加强层,从而为装置的远端弯曲和塑形提供期望的柔性。
参考图3A和3B更详细地描述一个实施方式中的导管的结构。如上所述,导管具有带中心孔150和封闭的远端或末端的管状主体。在可选的实施方式中,末端可以是开放的。在图示的实施方式中,导管的远端部分的偏转通过使用预塑形的偏转构件180完成,弯曲构件180包含在图3A的构造中在直线方向上受约束,以及在伸入图3B的弯曲构造中时采用弯曲形状。然而,可理解,在可选的实施方式中可使用在上文引用的第7,004,938号美国专利中描述的其它弯曲或塑形机构。如图3A和3B最佳所示,管状主体的远端部分140包括RF天线250,RF天线250包括柔性的、螺旋形盘绕的辐射天线设备255,辐射天线设备255嵌入在管状主体的柔性壁内。天线设备可因远端部分被塑形而弯曲,以与身体血管等相适应。天线设备相对的端部被连接至用于与近端连接器170相连的电导体或导线,从而连接至导管控制单元(未示出)中的RF能量源,将结合图4进行更详细地描述。在可选的实施方式中可提供其它天线设备,盘绕设备255的直径、螺距和长度以及用于设备255的导电材料可根据具体过程和柔性要求而变化。
将RF天线连接至连接器170的电导体可以是柔性网格或编线结构260或者是薄膜导电材料。在图3A和3B所示的实施方式中,导体示意性地显示为嵌入在导管的管状主体120的壁内的网格结构。在可选的实施方式中,可使用单独的导体给天线250供电。图4图示了具有集成电极312、314的修改的导管的第一实施方式的远端部分310。在一个实施方式中,这些电极是ECG电极,尽管在其它实施方式中它们可以是其它类型的电极。尽管在图4中图示了两个电极,但是在其它实施方式中可以提供一个电极或两个以上的这些电极。图4的导管的某些部件与图1至3中相同,相同的参考标号适当地用于相同的部件。在图4的实施方式中,一对同轴的内部管状导体315和外部管状导体316沿着管状主体318的长度延伸,外部导体316被连接至RF天线250的近端,内部导体315被连接至与导管的末端邻近的RF天线的远端。图4中未示出的管状主体318的其余部分的结构可以与上文描述的管状主体120相同,可以在导管的近端处设置类似的连接器170(未示出)用于将导体连接至适当的RF源。图4中所示的远端部分可通过类似的方式、并且使用与上文中结合图1至3描述相同或类似的控制装置塑形或弯曲。
在图4的实施方式中,管状主体318是介电材料(例如,非导电聚合物)并在其前端具有外径缩小的部分320。第一电极312包括柔性导电材料形成的套管,套管安装在管状主体的直径缩小的端部320上并具有在部分320的开放端上延伸的端部或末端322。RF或微波天线250嵌入在套管或电极312内。内部导体315和外部导体316如图所示延伸通过管状主体318,以连接至天线线圈250相对的端部。第二电极314包括安装在管状主体318上、位于从导电套管或电极312的后端向后隔开的位置处的一圈柔性导电材料。两个电极可通过粘合、胶合、机械力、热密封等固定在内部的管状主体318上。形成电极的柔性导电材料是至少基本非金属材料并且可以是可充分弯曲的导电聚合物材料,以允许远端部分310在如图1A与1B的位置之间弯曲。
在可选的实施方式中,电极环314可齐平地安装在管状主体的外表面中的环形槽或间隙内,或者可与管状主体模制成一体,使得它不会从主体318的外表面向外凸出。导体或连接器324从电极环314延伸到位于导管的近端处的连接器170,用于适当地连接至导管的控制单元(未示出)中的ECG监控器等。为了清楚起见,在图4中导体324显示为与主体318的外表面隔开,但是导体324可以是管状主体的外表面上的一行导电油墨或者粘合剂,或者可选地,导体324可嵌入在导体316外侧的主体318内。导体315或316中的一个还将连接至适用于对在两个电极312、314之间检测的信号进行监控的ECG或其它监控器。在一个实施方式中,两个电极都由柔性、导电聚合物材料(即,装有导电材料的聚合物材料)制成。
图5图示了具有修改的电极配置的导管的远端部分325,其中图4的电极环314由电极端帽330代替。电极312、330是柔性导电材料(例如,图4所示的导电聚合物材料)。在该实施方式中,其内安装有天线的导电套管312具有非导电聚合物材料形成的外覆盖层332,外覆盖层332沿着导电套管312的长度的至少部分延伸并在导电套管312的远端上延伸,以在第一电极312与第二电极330之间提供非导电屏蔽层。导体或连接器导线324从位于导管的近端处的连接器开始延伸,通过管状主体318的中心腔150,伸入电极端帽330,以提供电极与ECG监控器之间的信号路径。图5的导管的其它部分与先前实施方式中的导管相同,适当地使用相同的参考标号。导电套管312、非导电层332和端帽330可通过任意适当的方法(例如,胶合、热密封、粘合等)在管状主体318上层叠在一起。
图6图示了具有另一修改的电极配置的导管的远端部分340。该实施方式的阴极的部件与图4和5相同,相同的参考标号适当地用于相同的部件。与先前的实施方式不同的是,其内嵌入了天线线圈250的套管335不包括两个电极中的一个。与先前实施方式相同的是,套管335安装在管状主体318的直径缩小的端部320上,端部320由介电材料或非导电材料形成,天线线圈250在其相对的端部处被连接至内部导体315和外部导体316的远端。
在图6的实施方式中,非导电材料(例如,非导电聚合物材料)形成的外层336在导电套管335上延伸并具有在管状主体318的末端上延伸的端帽部分338。该实施方式中的电极包括安装在非导电层336外侧上隔开一段距离处的一对导电环339、341。环电极可以由导电聚合物材料形成。第一环339设置为与非导电的端帽部分338邻近,第二环341设置为与导电层336的后端邻近。中央导体或连接器导线342延伸通过管状主体318的空心中心孔或腔,通过非导电的端帽部分338,弯曲回到第一导电环电极339中并终止。在一个实施方式中,所示延伸通过腔150的连接器导线342的部分可以是在管状主体318的内表面上的一行导电油墨或者粘合剂。第二导体或连接器导线343沿着管状主体318的外侧延伸并被连接至第二导电环电极341。可理解,连接器导线343可包括管状主体318上的一行导电油墨或粘合剂,或者可选地,连接器导线343可在与外部管状导体316的外侧隔开的位置处嵌入管状主体318内。包括电极环的远端部分340的各种导电和非导电聚合物层适当地通过热密封、粘结等层叠在一起。
如图6所示,拉线355穿过腔150延伸到末端338并附接于位于导管近端处的适当的操纵和定位控制装置(未示出),用于控制远端部分的弯曲。该拉线机构在上文引用的第7,004,938号美国专利中描述,该专利的内容通过引用并入本文。可理解,在图4至6的实施方式中提供了类似的定位控制机构,或者可在这些实施方式中的任一实施方式中提供图3的机构180。
图7图示了根据另一实施方式的导管的远端部分400。同样,图7中所示的导管的某些部件与图4至6相同,适当地使用相同的参考标号。与先前的实施方式相同的是,柔性介电材料的管状主体318延伸导管的长度并具有中心通孔或腔150和外径缩小的端部320,在端部320上安装有套管312,套管312包含嵌入的RF天线250。与先前实施方式相同的是,套管312由导电聚合物材料形成,天线的末端通过延伸穿过管状主体318的外部柱状导体315和内部柱状导体316,以上文结合图1描述的方式连接至导管的远端连接器170(图1)。与先前的实施方式不同的是,非导电聚合物材料形成的外覆盖层345沿着导管的整个长度延伸,在管状主体318和套管312上延伸,并且具有对套管和管状主体的前端进行覆盖的前端或末端344。一对接触环346、348安装在导管的远端部分的外覆盖层345内,前接触环346位于套管312上并与该套管电接触,后接触环348位于相对套管312稍微往后的位置。每个环由柔性导电材料(例如,导电聚合物材料)形成。环346、348和外覆盖层345适当地粘合在一起,层叠在管状主体318和导电聚合物套管312上。
前接触环346通过导电套管312和外部导体316连接至近端连接器170,外部导体316还给天线250供电。后接触环348被连接至导电导线350,而且导电导线350穿过管状主体318延伸至导管的近端连接器170。因此,导体316、350为该实施方式中的控制单元的ECG监控器提供输出。
图7的实施方式还包括位于腔150中并与导管的末端邻近的温度传感器352。在图示的实施方式中,温度传感器352可以是热敏电阻、热电偶等,并具有热电偶连接或传感器端352和一对编织的导线或导体354,一对编织的导线或导体354从传感器352开始延伸,穿过管状主体,延伸到位于导管的近端处的连接器170,在那里它们被连接至用于监控导管的远端处的温度和用于控制天线工作的控制电路。与先前的实施方式一样的是,拉线355被附接至导管的末端344并延伸导管的长度通过中央腔150,以附接至适当的操纵和控制机构(未示出)。
用于监控和控制RF消融导管的工作且合并了温度传感器的系统在2006年6月30号提交的第11/479,259号共同未决的申请中描述,该申请的内容通过引用并入本文。可理解,在该实施方式或上文所述的其它实施方式中可提供适当地包含温度传感器的类似控制系统用于控制微波天线的工作。
图8图示了图5的实施方式的修改,相同的参考标号适当地用于相同的部件。在该实施方式中,与先前实施方式一样的是,具有中央腔150的、由介电材料形成的管状主体318延伸导管的整个长度,并在导管的远端部分500处具有外径缩小的部分320。导电套管312安装在部分320上,RF天线250嵌入在套管312内。与图5的实施方式一样的是,电极包括导电套管312和安装在导管的端部上的导电末端330,电极312与电极330之间具有非导电材料(例如,非导电聚合物)层332。图8的实施方式中的导电和非导电材料形成的各层还通过任意适当的方法(例如,加热、粘合和机械力)层叠在一起。
在图8中,去除了连接至图5的导电末端电极330的导电导线334,而由两个热电偶导线510代替,热电偶导线510从导管的近端连接器170开始延伸,穿过腔150,延伸到导电末端电极330内,位于两个导线的末端处的热电偶连接512提供了温度传感器。因此,热电偶导线具有两种功能,即,提供温度传感器输出,以及结合外部天线导体316提供ECG监控器输出。ECG输出可在导体316与热电偶导线510的任一根之间测得。如上文结合图7所述,温度输出可用于监控和控制RF天线的工作。
在图4至8的每个实施方式中,电极被安装在可塑形或可弯曲导管的远端部分,以使医生定位引起问题的组织区域并在消融之前和之后得到最佳的组织接近性和导电行为,还得到它们动作的反馈。尽管在这些实施方式中提供了两个电极,但是在其它实施方式中可提供仅一个电极或多于两个电极。这些实施方式中的电极可以是ECG或其它类型的电极。就像本领域公知的,位于导管的远端部分处的不透辐射(radio-opaque)标志物(未示出)也可用于协助定位导管的末端。当电极是ECG电极时,可理解,连接至电极和导管的近端连接器170的导体导线可通过适当的连接电缆与外部的ECG系统和监控器(未示出)通信,该连接电缆在电极与ECG系统之间传输ECG信号。天线导体和热电偶导线(如果温度传感器存在)将同样地连接于适当的天线输出控制系统。
在上文的每个实施方式中,RF天线250适用于接收和辐射电磁能量,以治疗选择的生物组织位置。在消融导管中使用的射频能量的适当频谱的实施例是高于300MHz的微波频率范围的频谱。RF天线能够在基本与天线250的纵轴线垂直的方向上,沿着RF天线应用基本均匀分布的电磁场能量。
图4至8的实施方式中的电极由适当的柔性导电材料制成,因而它们能够在操纵的时候与远端部分的其余部分一起弯曲。这些电极避免或减少了金属电极所遇到的问题,这是由于他们不吸收任何程度的微波能量,不会变得过热。这些电极可以由至少基本非金属材料制成,在一个实施方式中,它们由装有选择性导电材料的导电聚合物材料(例如,尼龙、聚乙烯、聚烯烃、聚丙烯、聚碳酸酯、Pebax
Figure A200780038910D0010140919QIETU
、热塑性弹性体(TPE)及混合物)制成。导管的其它非导电部件可由相同的聚合物材料或不同的聚合物材料制成。导电材料可以是微碳球、碳粒、纳米碳、镍尘等。这些电极可以完全由导电聚合物材料制成,或者可以是导电和非导电材料的混合物,或者可以是导电和非导电材料与金属基底的混合物。复合聚合物材料被选择为具有相对较低的阻抗用于减少与微波辐射图的干扰,并具有亲水性用于改进导管的外表面上的可湿润性(wetability)。
在某些实施方式中,可通过在聚合物表面应用导电油墨或粘合剂来提供电极与导管的近端处的连接器170之间的连通。例如,图4的导体324或图6的导体342可以是从电极环314延伸至导管的近端的、管状主体318外表面上的一行导电油墨或粘合剂。图7的导体350可以是非导电管状主体318的外表面上的一行导电油墨或粘合剂,非导电聚合物形成的外层345层叠在管状主体和导体导线350上。
在图4至8的实施方式中,可用热能、粘合和/或机械力来层叠导电和非导电聚合物层。金属基底也可以层叠在聚合物层之间(例如,在为操作RF天线250而供电的内部管状导体与外部管状导体之间)。
提供了公开的实施方式的上述描述使本领域的技术人员能够制造或使用本发明。这些实施方式的各种修改对本领域的技术人员是显而易见的,本文中描述的一般原理在不背离本发明的精神或范围的前提下能够应用到其它实施方式中。因而可理解,本文给出的说明书和附图表示本发明目前优选的实施方式,因此可宽泛地预见本发明的代表性主题。进一步理解,本发明的范围完全包含可对本领域的技术人员显而易见的其它实施方式,因此本发明的范围仅由权利要求限定。

Claims (34)

1.一种RF消融导管装置,包括:
细长导管,适用于插入患者的身体血管内,所述导管具有近端和远端部分,所述导管的至少所述远端部分是柔性的,使得所述导管的所述远端部分能够偏转;
射频(“RF”)天线,设置在所述导管的所述远端部分处,适用于接收用于消融生物组织的输入RF能量;
电连接器,位于所述导管的所述近端处,用于连接至所述RF天线的电源;以及
至少一个电极,设置在所述导管的所述远端部分处,与位于所述导管的所述近端且用于连接至监控器的所述连接器电连接,
所述电极由柔性的导电材料形成。
2.如权利要求1所述的装置,其中,所述电极是心电图(“ECG”)电极。
3.如权利要求1所述的装置,其中,所述电极的材料是至少基本非金属材料。
4.如权利要求3所述的装置,其中,所述电极的材料是柔性导电聚合物材料。
5.如权利要求1所述的装置,其中,所述导电材料包括装有导电材料的柔性聚合物材料。
6.如权利要求5所述的装置,其中,所述聚合物选自聚乙烯、聚烯烃、聚丙烯、聚碳酸酯、尼龙和热塑性弹性体材料。
7.如权利要求5所述的装置,其中,所述导电材料选自微碳球、碳粒、纳米碳和镍尘。
8.如权利要求1所述的装置,进一步包括至少一个电导体,所述电导体延伸通过所述导管,所述电导体的第一端连接至所述天线,所述电导体的第二端连接至所述近端的连接器。
9.如权利要求1所述的装置,其中,所述导管包括管状主体,所述电极包括安装在所述管状主体上的环。
10.如权利要求1所述的装置,其中,至少两个隔开的电极设置在所述导管的所述远端部分处。
11.如权利要求10所述的装置,其中,所述管状主体位于所述导管的所述远端部分处的至少一部分由非导电材料形成,所述电极包括在所述管状主体的非导电部分上的隔开的环。
12.如权利要求1所述的装置,其中,所述电极包括位于所述导管的所述远端部分处的细长套管。
13.如权利要求11所述的装置,其中,所述天线包括:嵌入所述电极的套管内的螺旋线圈;以及至少一个电导体,将所述天线连接至RF电源,以提供所述电极的套管与所述近端的连接器的电连接。
14.如权利要求13所述的装置,其中,所述电导体连接至所述螺旋线圈的第一端,所述螺旋线圈的第二端连接有第二电导体,所述第二电导体通过所述导管延伸至所述近端的连接器。
15.如权利要求11所述的装置,进一步由柔性的导电材料形成的第二电极,所述第二电极与所述电极的导电套管隔开。
16.如权利要求11所述的装置,进一步包括:非导电材料形成的外层,在所述电极的套管的至少一部分上延伸;以及柔性的导电材料形成的第二电极,安装在所述外层上。
17.如权利要求16所述的装置,其中,所述第二电极包括端帽,所述端帽在所述导管的所述远端部分上和所述外层的至少一部分上延伸。
18.如权利要求17所述的装置,进一步包括电导体,所述电导体延伸通过所述导管并连接至所述端帽,用于将所述端帽电连接至所述导管的所述近端的连接器。
19.如权利要求1所述的装置,进一步包括:温度传感器,安装在所述导管的所述远端部分中;以及一对热电偶导线,连接至所述温度传感器,并且通过所述导管延伸至所述近端的连接器。
20.如权利要求19所述的装置,其中,所述温度传感器连接至所述电极,所述热电偶导线的其中之一进一步包括所述第二电极与所述近端的连接器的电连接。
21.如权利要求20所述的装置,其中,所述电极包括位于所述导管的所述远端部分处的端帽,所述温度传感器嵌入在所述端帽内。
22.如权利要求1所述的装置,其中,所述导管包括:非导电材料形成的管状主体,从所述导管的所述近端延伸至所述远端部分;以及导电材料形成的外套管,安装在所述管状主体的所述远端部分上,所述外套管包含所述RF天线,所述电极包括与所述外套管电隔离的环。
23.如权利要求22所述的装置,其中,所述电极环被安装在所述管状主体的、与所述外套管隔开的位置处。
24.如权利要求23所述的装置,其中,所述外套管包括第二电极,所述第二电极电连接至所述近端的连接器。
25.如权利要求23所述的装置,进一步包括:非导电材料层,沿着所述外套管的长度的至少一部分延伸;以及第二电极,安装在所述非导电材料层上。
26.如权利要求1所述的装置,进一步包括偏转构件,适用于控制所述导管的所述远端部分的偏转。
27.一种RF消融导管装置,包括:
细长导管,适用于插入患者的身体血管内,所述导管具有近端和远端部分,所述导管的至少所述远端部分是柔性的,使得所述导管的所述远端部分能够偏转;
射频天线,设置在所述导管的所述远端部分处,适用于接收用于消融生物组织的输入RF能量;
电连接器,位于所述导管的所述近端处,用于连接至所述RF天线的电源;
一对同轴电导体,包括内部同轴电导体和外部同轴电导体,所述同轴电导体通过所述阴极,从所述天线延伸至所述电连接器;以及
至少一个电极,设置在所述导管的所述远端部分处,与位于所述导管的所述近端处且用于连接至监控器的所述连接器电连接,所述电极由柔性的导电材料形成。
28.如权利要求27所述的装置,其中,所述天线包括嵌入所述导管的所述远端部分内的螺旋线圈,所述线圈具有第一端和第二端,所述同轴电导体分别连接至所述线圈的所述第一端和所述第二端。
29.如权利要求27所述的装置,其中,所述电极包括位于所述导管的所述远端部分处的细长套管。
30.如权利要求29所述的装置,进一步包括柔性的导电材料形成的第二电极,所述第二电极与所述电极的导电套管隔开。
31.如权利要求29所述的装置,其中,所述天线嵌入在所述电极的套管内。
32.如权利要求27所述的装置,其中,由柔性的导电材料形成的至少两个隔开的电极被设置在所述导管的所述远端部分处,并且与用于连接至监控器的所述电连接器连接。
33.如权利要求32所述的装置,其中,所述电极的材料由柔性的导电聚合物材料形成。
34.如权利要求32所述的装置,其中,所述电极包括隔开的电极环。
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US8308722B2 (en) 2012-11-13
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EP2073738A2 (en) 2009-07-01
ES2546754T3 (es) 2015-09-28
WO2008051708A3 (en) 2008-06-19
US20080015570A1 (en) 2008-01-17
US20070066972A1 (en) 2007-03-22
CN101534737B (zh) 2011-07-06

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