CN1095641C - 电手术器械 - Google Patents
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Abstract
在一种用于在存在导电液体媒质的情况下治疗组织(例如:“水下外科”)的电手术器械中,双极电极组件具有一个有源电极,该电极具有一个暴露的组织治疗部分(34A),一个回路电极(38),该电极具有一个暴露的液体接触表面,和一个位于有源电极和回路电极之间的并使它们电绝缘的绝缘件(36)。绝缘件用于隔开暴露的有源电极治疗部分和回路电极的暴露的液体接触表面。电极的暴露部分和绝缘件的大小和形状是这样的,当电极装置浸在导电液媒质中时,有源电极和回路电极间的最长和最短的导电路径之比为2∶1。本发明还包括电手术器械与射频发生器的结合。
Description
技术领域
本发明涉及用于在存在导电液媒质的情况下治疗组织的电手术器械,和含这种器械的电外科装置。
背景技术
内窥镜电外科术用于治疗体腔内的组织,且通常是在存在膨胀媒质的情况下进行的。当膨胀媒质是液体时,通常称之为水下电外科术,该术语意指在电外科手术时活组织是用浸在术位的液体中的具有一个或多个电极的电手术器械治疗的。当内窥镜手术是在较大潜在容积的可膨胀的体腔内进行时,通常使用气体媒质,因为在这种情况下,液体媒质是不适合的,如在腹腔或胃肠手术的情况下。
水下外科通常使用内窥镜技术实现,按这种技术,内窥镜本身有一个用于电极通过的通道(通常称之为工作通道)。一种方案是内窥镜有专门适合于安装电极的装置(如前列腺切除镜),或者是电极通过一个相对于内窥镜成一个角度的单独的附加装置引入体腔,这种技术通常称之为三角形技术(triangulation)。在技术上的这些变化可以以外科专业细分,这些技术之一或另一种对特定的体腔的进入方法特别有利。具有一体的工作通道或这些特征的内窥镜,如前列腺镜,是通过天然的人体开口进入体腔时使用如进入子宫的子宫内膜腔的子宫颈,或者进入前列腺和膀胱的尿道。专门设计来供子宫内膜腔用的那些内窥镜称之为子宫镜,而设计来供尿道用的这些内窥镜包括膀胱镜,尿道镜和前列腺镜。尿道切除方法或前列腺汽化的程序是众所周知的,分别称为TURP和EVAP。当不存在内窥镜进入的天然的人体开口时,通常使用三角形技术(Triangulation)。三角形技术通常对关节腔,如膝和肩,在水下内窥镜手术时使用。用于这种手术的内窥镜通常称之为关节内窥镜。
电外科一般使用单极器械或双极器械进行。用单极的电外科,有源电极用于术区,而导电的回路板固定到病人的皮肤上。按这种结构,电流由有源电极经病人的组织流到外回路板。由于病人意味着是电路的一个值得注意的部分,输入功率必须较高(典型的是150瓦到250瓦)以补偿人体组织的阻流限制,且在水下电外科的情况下,功率受到由于液体媒质所致的损耗,所述的液体媒质是由于血液或其它体液的存在而提供部分导电性。使用高功率的单极结构也是危险的,这是由于在回路板处发生的组织变热,这可能导致严重的皮肤烧伤。还存在着器械和病人组织之间在进入体腔位置上的电容耦合的危险。
而双极电外科,一对电极(一个有源电极和一个回路电极)一起用在组织术位上。这种结构从安全观点来看是有利的,这是由于两个电极相对地比较接近,因此,射频电流限于两个电极间的区域内,然而,作用的深度是直接与电极间的距离有关,且在实用上要求很小的电极,这样,电极间的间隔变得很小,由此,限制了组织效应和输出功率。电极间的间隔进一步扩大通常将使术区的观察变得模糊不清,且应该需要在外科技术上进行改进,以保证两个电极能与人体组织直接接触。
双极探头的结构有很多改进,例如,美国专利说明书US-4,706,667公开了一种基本结构,即用于切割的,回路电极的接触面积与有源电极的接触面积之比应大于7∶1,但小于20∶1,这个范围只涉及切割电极结构。当双极器械用于干燥或凝固时,两个电极的接触面积的比降低到接近于1∶1,以防止在组织和电极间的接触处发生不同的电应力。
回路电极和组织间的电连接可以用导电液,如通常的盐水,通过弄湿的组织支承。这样就保证了外科作用限于针头或有源电极及由组织接通的两个电极间的电路。对结构明显的限制之一是针头必需在组织中整个地掩埋,以便使回路电极能接通电路。另一个问题是定向问题,从理想的与各组织表面的垂直接触来看,甚至在施放角度上的相对小的变化都将导致接触面积上的变化,由此,外科作用可以在与回路电极接触的组织上发生。
腔体的膨胀为有利于进入术位,改进可视性和对器械的操作控制提供了空间。在小体积的体腔中,特别需要在高压力下使腔体膨胀,液体比气体更常用,因为它们具有良好的光学特性,还因为它们可以清洗术位的血液。
已有技术的水下电外科是使用非导电的液体(如1.5%甘氨酸)作为冲洗剂,或作为膨胀媒质,或减少导电损失。甘氨酸用在等渗压浓度用于防止当发生血管内吸收时在血液中的渗透变化。在手术过程中,随着灌注的液体进入循环系统,可能对静脉带来危险,它可能引起血清钠(serum sodium)的稀释等,从而导致众所周知的水中毒状态。
发明内容
申请人已经发现能够在水下内窥镜电手术中用一种导电的液体介质,如普通的盐,来替代非导电的无电解质的溶液。普通的盐在水下内窥镜外窥镜外科中是优选的膨胀介质,当不考虑电外科时,或使用非电的组织效应时,例如,使用激光治疗时。尽管通常的盐(0.9%W/V,150mmol/l具有比大多数人体组织稍高的电导率,它具有通过吸收或渗出从术位位移产生微小的生理作用的优点,并避免了称之非导电体的,无电解质溶液的水中毒作用。
申请人已研制了一种使用导电液媒质的,适用于水下电外科的双极器械。本发明的第一个方面,提供了一种用于在存在导电液体媒质的情况下治疗组织的电手术器械,包括一个限定了纵轴的器械轴和一个在器械轴远端的电极组件,其中电极组件包括:一个具有暴露的组织治疗部分的固定位于电极组件上的单个的有源电极,一个具有暴露的液体接触表面的回路电极,所述回路电极和所述有源电极在纵轴的方向上相互分开,和一个位于有源电极和回路电极之间、使它们电绝缘的一个绝缘件,用回路电极将绝缘件的末端短接,使得绝缘件将有源电极的暴露的组织治疗部分与回路电极的暴露的液体接触表面在纵轴上隔开,由此,当所述暴露的组织治疗部分与浸入液体媒质的组织表面邻接时,所述暴露的液体接触表面从所述组织表面向后配置,且液体媒质形成有源电极和回路电极之间的导电通路;且其中暴露治疗部分、暴露的液体接触表面和绝缘件的尺寸和结构是这样的,当电极组件浸入导电液体媒质时,(i)在暴露的液体接触表面和离暴露的液体接触表面最远的那部分暴露治疗部分之间的经液体媒质的最短导电路径的长度P1和(ii)在暴露的液体接触表面和暴露组织治疗部分之间的经液体媒质的最短导电路径的长度P2之比,是在1.25∶1到2∶1之间的范围内。
优选地在按照本发明的器械中,有源电极的暴露组织治疗部分从绝缘件按一个第一方向凸出,回路电极的液体接触表面是从有源电极的暴露组织治疗部分向后配置,绝缘件围绕有源电极近端且在有源电极的暴露组织治疗部分和回路电极的液体接触表面之间,在垂直于上述第一方向的第二方向上向外凸出,以限定一个绝缘屏障,改变经液体媒质的电流的流动方向,由此,增加了在暴露的液体接触表面和暴露的治疗部分之间的最短导电路径长度P2。
优选地在根据本发明的器械中,在暴露的液体接触表面和暴露的治疗部分之间的经液体媒质的最短导电路径长度P2至少为1mm。
优选地在根据本发明的器械中,暴露的液体接触表面通常是圆柱形的,且有一个长度和一个直径,液体接触表面的长度至少与其直径一样大,和其中,(i)在暴露的液体接触表面和离液体接触表面最远的那部分暴露的组织治疗部分之间的经液体媒质的最短导电路径长度P1与(ii)暴露的液体接触表面直径之比最大为4.5∶1。
优选地在根据本发明的器械中,回路电极包括一个在有源电极的暴露的治疗部分之后的包围绝缘件的导电套。
优选地在根据本发明的器械中,器械轴包括一个作为其主结构元件的金属管,和所述回路电极在管的远端部分上一体形成。
优选地在根据本发明的器械中,所述暴露的组织治疗部分是一个导电的轴向凸出物,所述暴露的液体接触表面是围绕所述绝缘件的导电的外套,且与所述暴露的组织治疗部分至少在轴向上隔开1mm。
优选地在根据本发明的器械中,有源电极的暴露的组织治疗部分从所述轴的远端纵向延伸。
优选地在根据本发明的器械中,所述绝缘件包括一个通常为圆柱形的套,所述回路电极位于套的外面,并与所述有源电极的暴露的组织治疗部分以至少1mm的距离纵向隔开。
优选地在根据本发明的器械中,所述绝缘件具有一个定义了一个台肩的环形远端面,所述有源电极的暴露的组织治疗部分相对于绝缘件端面的中心定位并从该面凸出,所述台肩在横向远离有源电极的深度在0.05L到0.5L之间,L是所述有源电极的暴露的组织治疗部分的长度。
根据本发明的第二方面,提供了一种包含前述的器械的电外科系统,它进一步包括一个用于向上述器械供给射频功率的电手术发生器,所述的发生器包括一个输出级,该级至少具有一对可分别连接到所述器械的有源电极和回路电极上的电手术输出连接装置,一个用于获得在两个输出连接之间发生的表示峰值射频输出电压的传感信号的传感电路,和一个用于当传感信号指示预定的峰值射频输出电压已达到时自动地减少所输送的输出电压的功率调节电路。
优选地在根据本发明的系统中,所述功率调节电路当传感信号指示所说的阈值已达到时可操作使所传输的输出功率至少减少50%,所说的减少在100μs或更短的期间内完成。
优选地在根据本发明的系统中,所述功率调节电路可操作来使所说的减少在20μs或更短的期间内完成。
优选地在根据本发明的系统中,所述输出级至少包括一个射频功率装置,其中所述控制电路是配置成使在输出电压上至少减少50%是通过减少在对装置供给电压的各个射频振荡周期中的装置导电持续期实现的。
优选地在根据本发明的系统中,所述传感电路和功率调节电路是可重复地操作的,以实现功率装置从峰值电平到低谷电平的导电持续期按一周到一周的快速减少,接着是在导电持续期不那么快速地渐进增加,直到导电持续期再达到它的峰值值,快速减少和渐进增加序列是重复的,而且同时减少对所说的输出级供给的电压,直到所说的峰值导电周期值被达到,而输出的电压不会超过所说的阈值。
本发明的器械的电极结构以及与之相联系的导电液媒质极大地避免了单极或双极电手术所存在的问题。事实上,输入功率电平远低于单极结构通常所需的电平(典型地是100瓦)。而且,由于电极间相对大的间隔,可获得较已有技术的双极结构改进了的作用深度。
现在,本发明将结合附图中所示的实例进行说明。
附图说明
图1是说明按照本发明的电外科系统的示意图;
图2是构成图1的系统的一部分电手术器械部分的侧视图;
图3是按照本发明的另一种电手术器械按纵向轴剖视的剖面图;
图4是说明使用按照本发明的器械在干燥和汽化两种模式间发生的电负载阻抗滞后和消耗的射频功率曲线;
图5是图1所示电外科系统的发生器的方框图;
图6是图3所示器械的示意侧视图,说明使用本发明的器械通过汽化去掉组织;
图7是类似于图6所示的器械的示意侧视图,说明使用本发明的器械对组织干燥和凝结;和
图8,9和10是按照本发明的其它电手术器械的侧视图,说明不同的电极和绝缘结构。
具体实施方式
参照附图,图1所示的电外科装置包括一个电手术发生器10,它具有一个向以手柄12和可拆的电极单元28的形式的双极器械通过电缆14提供射频(RF)输出的输出插座10S。发生器10的启动可由手柄12经在电缆14中的控制连接,或者如图所示的脚踏开关16通过脚踏开关连接电缆18单独地连接到发生器10的后面实现。在所示的实施例中,脚踏开关单元16具有两个脚踏开关16A和16B,分别用于选择发生器10的干燥模式和汽化模式。发生器的前面板上具有按钮20和22,分别用于置定干燥和汽化的功率电平,该电平示于显示器24。按钮26作为用于干燥和汽化模式之间的选择而提供的另一个装置。
器械无需包括手柄,但可以简单地包括一个用于装到另一个装置,如前列腺镜上的连接器。图1中所示的是器械具有装到手柄12上的电极单元28。
电极单元28可以有各种不同的形式,下面说明其中的几种。
在图2所示的基本结构中,用于可拆地固定到器械手柄上的电极单元包括一个可以是用绝缘外壳30S覆盖的,在远端处具有电极组件32的导电管的轴30。在轴的另一端(未示出)是一个用于把电极单元机械地和电地连接到手柄上的装置。
电极组件32包括一个暴露在单元的最远端的以形成电极的治疗部分的中心有源电极34。优选的有源电极是金属丝,它作为中心导体通过整个轴30延伸到近端的连接处(附图中未示出)。围绕电极34和内导体的是一个绝缘套36,其远端在靠近暴露的电极34的治疗部分处暴露。这种套典型地是用陶瓷材料制成,以阻止来自电弧的伤害。围绕绝缘套36是金属管形式的回路电极38,它与轴30的金属管体电学地成一体(且也可以选择为机械地成一体)。该回路电极在未达到套36位置就终止,因此,它缩进在有源电极34暴露的治疗部分的后面,且两者径向地和轴向地从套36隔开。应该明白,原则上由于回路电极比有源电极的直径要大得多,回路电极提供的暴露的液体接触表面的表面积要比暴露的有源电极处理部分要大很多。绝缘外壳30S在与回路电极38的远端较近的隔开位置上端接,以便为回路电极液体接触表面提供所需要的表面积。在电极单元的远端,回路导电体的直径典型地在1到5毫米的范围内。回路电极38所暴露的部分液体接触表面的纵向程度典型地在1~5毫米之间,且回路电极38与暴露的有源电极治疗部分纵向隔开的距离在1~5毫米之间。下面将进一步详细说明电极装置的其它方面的结构和尺寸。
事实上,图2中所示的电极结构是一个双极的结构,且只有一个电极34实际上延伸到电极单元的远端。这意指在正常使用的情况下,当电极装置插在导电液媒质中时,回路电极38保持与所治疗的组织隔开,电流的路径存在于经组织与回路电极接触的导电液媒质的两个电极之间。
电极间的轴向间隔就直径而论可以容许非常精细的电极结构,因为绝缘路径明显地比只具有在暴露的电极表面间的径向间隔的双极电极要大得多。这就能使用比传统电极结构更高的功率,而且不会引起不希望的电弧;或者在电外科切割或汽化治疗的情况下,不会引起由于在高温下过份的电弧所致的使电极单元损坏。
所示的特殊的交错配置使外科大夫能看到组织接触电极的顶部,且相对于组织表面具有较大的施放角范围,这在典型的内窥镜外科的窄小空间内特别重要。
参照图3,用于可拆的固定到图1所示的电手术器械手柄12上的另一种电极包括一个轴30,该轴由不锈钢或在铜或金上电镀了苯氧树脂(phynox)做的半柔性管构成,且在其远端具有一个电极组件32,在轴30的另一端(未示出),有一个用于机械地和电地把电极单元连接到手柄上的装置。
电极组件32包括一个中心的有源或组织接触电极34,该电极由铂,铂/铱,或铂/钨材料制成,并由通常为半球形暴露的头部34A和一体的中心导电体34B组成,导电体34B通过一个固定到导电体34B和34C靠近端部上面的薄的不锈钢弹簧34D电连接到中心铜导电体34C上,由此,在器械的手柄和暴露的头部34A之间形成电连接。陶瓷的绝缘套36围住导电体34B,弹簧34D和铜导电体34C的靠近端部的部分。袖套36具有围绕导体34B的远端的暴露部分36A。形成轴30的远端部分并提供圆柱形流体接触表面的回路电极38紧围住套36,并延伸到由绝缘套40将后者隔开的铜导电体34C上。外绝热套或聚酰亚胺涂层30S包住轴30和回路电极38的近端。
当用在与如图1所示的电手术器械结合时,图3的电极单元用于导电流体媒质中,以便通过汽化去掉组织,在关节镜外科中雕刻和使半月板成形,或用于干燥,这一切决定于控制发生器的方式。图4示出了如何控制发生器,以便取得在电极单元的干燥和汽化两模式之间存在的滞后的好处。由此,假定单元的电极组件32是浸在导电媒质中,例如盐中,在点“O”处存在着初始的负载阻抗“r”,其大小由电极组件的几何关系和液体媒质的电导性确定。当有源电极34接触组织时,r值变得越高,电极组件32越倾向于进入汽化状态。当RF功率施加到电极组件32上时,流体媒质变热。假定流体媒质是普通的盐溶液(0.9%w/v)时,流体媒质导电性的温度系数是正的,因此,相应的阻抗系数是负的。由此,当施加功率时,阻抗开始时降落,且继续随功率的增加而降落到“B”点,在该点上,与电极组件32紧密接触的盐溶液达到了其沸点。小的蒸汽泡出现在有源电极的端部34A的表面上,阻抗开始上升。在“B”点之后,当功率消耗进一步增加时,阻抗的正功率系数是主要的,因此,功率的增加引起阻抗的增加。
由于蒸汽包是由蒸汽汽泡形成。在驻留电极/盐溶液界面处功率密度将增加。然而,存在着没有由蒸汽汽泡覆盖的有源电极端部34A的暴露区域,这将进一步使界面受压,产生更多的蒸汽汽泡,由此甚至有更高的功率密度。这是一个失控条件,且均衡点只有在电极完全被围在蒸汽内时才发生。对于给定的变量组,存在着一个在新的均衡达到之前(“C”点)的功率阈值。
因此,在“B”点和“C”点之间的区域表示干燥模式的上限。一旦在汽化均衡状态,阻抗很快地增加到1000欧姆左右,而绝对值决定于系统的变量。因此蒸汽包是通过在有源电极头部34A和蒸汽/盐溶液界面间的蒸汽包排放来维持。主要的功率损耗发生在该包内,结果是使头部34A发热。能量损耗量和包的大小决定于输出电压。如果太低,包就不能维持,而太高,将使电极组件32损坏。因此,为防止电极组件32破坏,一旦阻抗已到达“D”点,必需减少发生器的功率输出。应该注意:如果功率在这点上没有减少,功率/阻抗曲线将继续向上升,将发生电极破坏。虚线E表示功率电平,在该电平之上电极破坏是不可避免的。当功率降低时,阻抗将回落直到在A点蒸汽包破坏,而电极装置又回到干燥模式。在这点上,蒸汽包内的功率损耗不足以保持它,由此,再次重建有源电极头部34A和盐溶液间的直接接触,且阻抗也显著地下降。在头部34A上的功率密度也下降,由此,盐溶液的温度将下降到沸点之下。之后,电极组件32是处于稳定的干燥状态。
控制发生器功率以获得所要求的干燥、组织切割和汽化功能是通过传感出现在发生器输出连接处的峰值RF电压和通过快速地降低所输送的输出功率来实现的,一旦预选的峰值电压已达到。至少在干燥模式,这种功率降低明显地比只将峰值输出电压降到阈值以下要多。优选的功率降低至少是50%,以便取得参照图4所作的上述说明的滞后特征的优点。
参考图5,发生器包括一个具有一对输出连接器60c的射频(RF)功率振荡器60,该连接器用于使用时通过输出端62耦合到由电极组件表示的负载阻抗64上。能量由开关模式电源66供给振荡器60。
在优选的实施例中,RF振荡器工作在大约400KHz,且在300KHz以上直至HF的任何频率都是可行的。开关模式电源典型地在25到50KHz范围的频率上工作。经输出连接器60c耦合的是一个电压阈值检测器68,它具有耦合到开关模式电源16的第一输出68A,和耦合到“接通(on)”时间控制电路70的第二输出68B。耦合到操作器和显示器的微处理器控制器72(见图1)连接到电源66的控制输入66A上,以便通过供给的电源电压的变化调节发生器的输出功率,并连接到电压阈值检测器68的阈值置定输入端68C,以置定峰值RF输出电压限制。
在使用时,微处理器控制器72把功率施加到开关模式电源66上,当电手术功率由外科医生操作可以在手柄或脚踏开关上提供的启动开关装置而要求时。恒定的输出电压阈值是按照在发生器前面板的控制置定通过输入端68C独立置定的电源电压(图1)。典型地,对于干燥或凝固,阈值置定在150伏到200伏之间的干燥阈值上。当要求切割或汽化输出时,阈值置定在250或300伏到600伏范围内的电压值上。这些电压值是峰值。这意味着对于干燥优选地至少在电压箝位到给定值之前对于给定的最大功率具有低的峰值因子的RF波形。峰值因子典型地应达到1.5或更低。
当首先起动发生器时,RF振荡器60(它连接到“接通”时间控制电路70)的控制输入端60I的状态是“接通(on)”,因此,构成振荡器60的振荡元件的功率开关装置,在每个振荡功率循环中具有最大导通持续期。传送到负载64的功率部分地决定于由开关模式电源66施加给RF振荡器60的电源电压,部分地决定于负载阻抗64。如果电源电压足够高,围绕电手术器械电极的液体媒质的温度(或者是气体媒质内,容纳在组织内的液体温度)将上升到这样一种程度,即液体媒质汽化,导致负载阻抗快速地增加,接着通过接点62施加的输出电压也将快速增加。这是一种不希望的意外状态,如果需要干燥输出时。为此,当达到阈值时,用于干燥输出的电压阈值置定为对“接通”时间控制电路70和开关模式电源66发送一个触发信号。“接通”时间控制电路70具有有效地瞬时降低RF振荡器开关装置的“导通”时间的作用。同时开关模式电源截止,由此,供给振荡器60的电压回落。
发生器的输出电压对操作模式是重要的。事实上,输出模式纯粹地是由输出电压,特别是峰值输出电压决定。输出电压的绝对值只是对多项控制是需要的。然而,在这种发生器也可以使用简单的单项控制(亦即使用一个控制变量),以便约束输出电压到预定限制电压的。由此,在图5中所示的电压阈值检测器68将RF峰值输出电压与预置的DC阈值电平比较,并具有足够快的响应时间以在一个RF的半周期内对“接通”控制电路70产生一个复位脉冲。
最大的吸收功率与在蒸汽泡形成之前瞬间存在的电极状态是一致的,因为这与最大功率分布和最大的被弄湿的电极面积是一致的。因此,对于最大的干燥功率希望电极保持在被弄湿的状态。使用电压限制检测将引起功率降低,该降低使蒸汽泡弄破。这样又增加有源电极吸收功率的能力。由于这个原因,发生器具有一个大过调量的控制回路,在该回路中,峰值电压达到预定阈值的反馈触发导致在功率上的瞬时的下降,这是由于峰值输出电压明显地降到由阈值检测器68所置定的峰值输出电平之下引起的。这种控制过调量保证了回到所要求的弄湿状态。
对发生器和它的操作的更详细说明见欧洲专利申请NO.0754437A。
按上述说明,应该明白,图3的电极单元可以通过使该单元在“D”点和在“B”点与“C”点间的范围中的一个点之间的图形范围内操作而用于干燥。在这种情况下,电极组件32进入有源电极的头部34A接近欲治疗的组织的所选术位,且组织、有源电极的头部和回路电极已浸入在盐溶液中。然后启动发生器(并如上所述循环控制)对电极组件32供给足够的功率,以便使在有源头部34A附近的盐溶液保持在沸点或刚好在其沸点之下,且在有源头部周围不产生蒸汽腔。控制电极组件以使组织在有源头部34A的附近在要求的范围内加热和干燥。电极单元可以用于在“D”点和构成在一种电平的虚线E之间的图形区域内汽化,在这种电平下的汽化将不再是稳定的。该曲线的上面部分是用于通过汽化的方式去掉组织。按这种模式,把器械放在欲治疗的组织上的应用可以实现雕刻和整形(contouring)。
电极装置32优选的具有其回路电极:有源电极的表面积在5∶1到40∶1范围内的一体式电极(亦就是说,两个电极的暴露部分的表面积比在这个范围内)。
图6说明图3的电极单元通过汽化去掉组织的用法,所述的电极单元浸在导电液78内。由此,电极单元在有源端部34A处产生一个足够高的能量密度,以汽化组织80,并产生一个围绕有源头部的蒸汽包82。蒸汽包82的形成在接触阻抗上产生约10倍的增量,接着增加输出电压。电弧84在蒸汽包82内产生,把电路与回路电极38接通。接触蒸汽包82的组织表示接通电路的最小电阻路径。组织80越接近达到有源头部34A,越多的能量集中到组织上,其程度为细胞由于受到电弧84的轰击而破裂,因为通过连接液体(在这种情况下是盐溶液)的回路是由蒸汽包82的高阻抗屏障阻断。盐溶液也起到溶解或扩散汽化的固体产品的作用。
使用时,电极装置32引入所选择的术位,且有源头部34A靠近被汽化的组织,有源头部和回路电极38浸在盐溶液78内。启动RF发生器,把足够的功率(如前参照图4所说明的)供给电极装置32以蒸发盐溶液,并保持围绕接触电极的组织的蒸汽包。当电极单元用于在关节镜外科中雕刻或成形半月板时,电极装置32在所述术位上施以轻的压力(light-pressure)并加以控制,以便有源头部34A的部分球表面通过欲治疗的表面移动,将组织弄成光滑,且对特殊的半月板具有雕刻和成形的作用。
图7说明与图3相同的电极单元用于组织干燥的用法。在干燥模式中,输出功率按第一输出范围输送到电极,由此电流由有源电极34流到回路电极38。如上所述,输出功率使靠近有源电极34的盐溶液加热,优选的是加热到盐溶液的沸点或接近沸点。这样就在有源电极34的表面上产生小的蒸汽泡,该汽泡增加了围绕有源电极34的阻抗。
人体组织80典型地具有比靠近有源电极34的蒸汽泡和盐溶液相结合的阻抗要低的阻抗。当由蒸汽泡和盐溶液围绕的有源电极34在与组织80接触时,组织80成为部分优选的电流路径,因此,优选的电流路径从组织接触位置处的有源电极34,经组织80,然后经盐溶液返回到回路电极38,见图7所示。
本发明在干燥组织方面具有特殊的用途。为了干燥组织,人们优选的途径只是部分的有源电极与组织接触,而有源电极的剩余部分保持远离组织且由盐溶液围绕,由此电流是从有源电极经盐溶液到回路电极,而不通过组织。例如,在图7所示的实施例中,只有有源电极的远端部分接触组织,而近端部分与组织隔开。
本发明可以实现没有或很少烧焦组织的干燥。当有源电极34接触组织80时,电流通过组织,使在和围绕接触点的组织干燥。被干燥的组织区域和体积通常从接触点径向向外延伸。
在图7所示的实施例,有源电极34的暴露的治疗部分长度上比其宽度大,这就使电极的头部能接触组织表面,而仍保留大部分暴露治疗部分不与组织接触,甚至在器械与组织表面成一个角度的情况下。由于大部分暴露的电极部分是不与组织接触,电流的路径在足够的组织容积上将很容易地从经过组织的路径到直接地由有源电极进入盐溶液偏移。
在图3所示的电极单元,有源电极34的暴露部分相对地要比有源电极34和回路电极38之间的绝缘件36的长度要短,就这种电极结构,采用了上述参照图4所述的固有的滞后特征的器械的双稳态操作,就这种操作方式,器械可以用在干燥模式或低功率的汽化模式。在某些情况下,特别是如果有源电极的暴露治疗部分是长的,要实现双稳态操作是困难的。
克服这种困难的办法现将结合附图8说明,该图示出了一个电极单元,该电极单元包括一个由不锈钢或者在铜或金上电镀了苯氧树脂(phynox)制的半柔性管组成的轴30,且电极组件32是装在其远端上。电极组件32包括一个具有细长的暴露的治疗部分34A(也可以称之为“针状”电极)和一个一体的中心的导电体34B的中心有源电极34。圆柱形的陶瓷绝缘套36包住导电体34B,和一个由轴30的远端部分构成的毗邻套36的近端的回路电极38。一个外绝缘聚酰亚胺包覆层40在接近回路电极38处围住轴的近端,由此提供了一个具有由包覆层40延伸到套36的环状液体接触表面的回路电极。绝缘套36具有一个径向的远端面36A,其直径使得台阶半径(即端面36A的周边和有源电极34的直径间的距离)至少是暴露的有源电极治疗部分34A的长度的二十分之一。由此,绝缘套36具有与有源电极34同轴的台肩(或台阶)。使用时,这个台阶避免了暴露的有源电极治疗部分34A在相反情况下发生的局部电弧,以便使治疗部分的远端不起作用。
为了更详细的讨论电极的操作,当电极单元在组织切割或汽化模式下工作时,蒸汽泡围绕着有源电极治疗部分34A形成。这种汽泡由其内的电弧维持。施加的电压越大,汽泡的尺寸也越大。由每个电弧所消耗的能量是由留在导电路径内的剩余液体的阻抗和受发生器的源阻抗限定的。然而,电弧是起到负阻抗的作用,其中如果电弧中的能量足够的高,形成一个阻抗非常低的电离路径。这可能导致一个不断降低电离路径阻抗的不稳定状态,除非汽泡和回路电极间的液体的阻抗足以对消耗的功率起到限制作用。对于围绕有源电极治疗部分的蒸汽包还可能侵犯回路电极。在这些环境下,电弧的能量只受到发生器源阻抗的限制,但这种功率限制是很低的,且不可能按照电极大小调节。由于这些原因,绝缘套36的大小和结构应该达到有源电极治疗部分34A和回路电极38的液体接触表面间的1mm的最小导电路径长度的程度。这种最小路径长度在图8所示的实施例的情况下,如图8所示,是套36的长度a加上台阶半径c。
进一步考虑的是只在部分有源电极34的暴露治疗部分34A上形成蒸汽包的可能性。当施加的电压和功率足够大时,蒸汽包将围绕有源电极暴露的治疗部分形成。优选的是包在整个治疗部分长度上均匀形成。在这种情况下,存在于发生器的负载阻抗可以大到20倍的变化。然而,当回路电极液体接触表面和暴露的有源电极治疗部份34A的不同部分之间在导电路径长度上存在明显差异时,电压梯度是建立在每个电极的长度上。优选地,液体接触表面应足够的大,且应具有一个长宽比,亦即它的长度至少应与其直径一样大,以便使其表面上的电压梯度最小。尽管如此,对于某些绝缘套和有源电极的结构,电压梯度可以大到足以使蒸汽包只在最接近于液体接触面上的部分的暴露的治疗部分上形成,舍去了仍与导电液接触的暴露的治疗部分的最远端。因此,电压梯度是在导电液内的蒸汽包的边缘与有源电极治疗部分34A的表面交叉的部位建立。这种部分地包围有源电极治疗部分的电学行为与整个地包围治疗部分的情况非常不同。由弄湿状态到蒸汽包围状态的阻抗变化远不如上面参照图4所说明的显著。按照由传感峰值电压控制发生器的输出,电极组件的行为不再是双稳态的,然而,功率的需要是由于通过有源电极治疗部分的低阻抗被弄湿的区域内存在蒸汽电压的缘故被认为是较高的。临床效果不仅仅需要汽化,而且不需要由于增加功率消耗所带来的热伤害效果。
部分地包围有源电极治疗部分可以通过保证电极治疗部分的最远点和有源电极治疗部分与液体接触表面间的最短导电路径长度之间的导电路径长度比小于或等于2∶1,即b/(a+c)≤2来防止。
在某些环境下,可以发现有源电极和回路电极之间的导电路径长度太长,以至于由于跟着发生的由液体表示的大的串联阻抗所致的导电液汽化。太大的电压降可能导致在达到汽化之前已达到预置的电压阈值。因此,最大的路径长度与回路电极的液体接触表面的环形周边长度之比优选地是不超过1.43∶1。在圆柱形液体接触表面的情况下,接触表面与有源电极同轴,最大的导电路径长度与液体接触表面直径之比应小于或等于4.5∶1。由此,参照图8,b/d≤4.5。
图8所示的电极单元的主要用途是用于切割组织,且至少部分的有源电极治疗部分34A掩埋在欲治疗的组织内和发生器在图4中所示的阻抗/功率特征的汽化部分工作。
另一种有源电极的结构包括一个如图9所示的形成的暴露治疗部分34A如同一只钩。在这种情况下,绝缘套36是锥形的,从回路电极38的液体接触表面到远端面36A逐渐尖细。
又一个实施例示于图10,其有源电极治疗部分34A是成圈形钩的形状。
在图8,9和10的实施例中,应该看到,尺寸a,b,c,d都是在前述的比值限定范围内。因此,在每一种情况,电极组件可以被看作为具有一个治疗轴42,沿着它器械可以向组织引入,而回路电极38是一个按治疗轴方向从有源电极的暴露的治疗部分34A反置的轴。为了比较回路电极和有源电极治疗部分的不同部分之间的不同导电路径长度,应该考虑在公共平面内的长度,所说的平面包括治疗轴42。在图8,9和10所示的情况下,当然,所示的路径长度是在低平面内的方向观察。
Claims (15)
1.一种用于在存在导电液体媒质的情况下治疗组织的电手术器械,包括一个限定了纵轴(42)的器械轴(30)和一个在器械轴远端的电极组件(29),其中电极组件包括:
一个具有暴露的组织治疗部分(34A)的固定位于电极组件上的单个的有源电极(34),
一个具有暴露的液体接触表面的回路电极(38),所述回路电极(38)和所述有源电极(34)在纵轴(42)的方向上相互分开,和
一个位于有源电极(34)和回路电极(38)之间、使它们电绝缘的一个绝缘件(36),用回路电极将绝缘件(36)的末端短接,使得绝缘件将有源电极的暴露的组织治疗部分(34A)与回路电极(38)的暴露的液体接触表面在纵轴上隔开,由此,当所述暴露的组织治疗部分与浸入液体媒质的组织表面邻接时,所述暴露的液体接触表面从所述组织表面向后配置,且液体媒质形成有源电极和回路电极之间的导电通路;
特征在于所述暴露的组织治疗部分(34A)、暴露的液体接触表面和绝缘件(36)的尺寸和结构是这样的,当电极组件(32)浸入导电液体媒质时,(i)在暴露的液体接触表面和离暴露的液体接触表面最远的那部分暴露治疗部分(34A)之间的经液体媒质的最短导电路径的长度(P1)和(ii)在暴露的液体接触表面和暴露组织治疗部分(34A)之间的经液体媒质的最短导电路径的长度(P2)之比,是在1.25∶1到2∶1之间的范围内。
2.按照权利要求1所述的器械,特征在于有源电极(34)的暴露组织治疗部分(34A)从绝缘件(36)按一个第一方向凸出,回路电极(38)的液体接触表面是从有源电极的暴露组织治疗部分(34A)向后配置,绝缘件(36)围绕有源电极近端且在有源电极的暴露组织治疗部分(34A)和回路电极的液体接触表面之间,在垂直于上述第一方向的第二方向上向外凸出,以限定一个绝缘屏障,改变经液体媒质的电流的流动方向,由此,增加了在暴露的液体接触表面和暴露的治疗部分之间的最短导电路径长度(P2)。
3.按照权利要求1或2所述的器械,特征在于在暴露的液体接触表面和暴露的治疗部分(34A)之间的经液体媒质的最短导电路径长度(P2)至少为1mm。
4.按照前述权利要求1或2的器械,特征在于暴露的液体接触表面通常是圆柱形的,且有一个长度和一个直径,液体接触表面的长度至少与其直径一样大,和其中,(i)在暴露的液体接触表面和离液体接触表面最远的那部分暴露的组织治疗部分(34A)之间的经液体媒质的最短导电路径长度(P1)与(ii)暴露的液体接触表面直径之比最大为4.5∶1。
5.按照权利要求1或2所述的器械,特征在于回路电极(38)包括一个在有源电极(34)的暴露的治疗部分(34A)之后的包围绝缘件(36)的导电套。
6.按照权利要求1或2所述的器械,特征在于器械轴包括一个作为其主结构元件的金属管,和所述回路电极(38)在管的远端部分上一体形成。
7.按照权利要求1所述的器械,特征在于所述暴露的组织治疗部分(34A)是一个导电的轴向凸出物,所述暴露的液体接触表面是围绕所述绝缘件(36)的导电的外套(38),且与所述暴露的组织治疗部分(34A)至少在轴向上隔开1mm。
8.按照权利要求1或2所述的器械,特征在于有源电极的暴露的组织治疗部分(34A)从所述轴(30)的远端纵向延伸。
9.按照权利要求8所述的器械,特征在于所述绝缘件包括一个通常为圆柱形的套,所述回路电极(38)位于套的外面,并与所述有源电极的暴露的组织治疗部分(34A)以至少1mm的距离纵向隔开。
10.按照权利要求9所述的器械,特征在于所述绝缘件(36)具有一个定义了一个台肩的环形远端面(36A),所述有源电极的暴露的组织治疗部分(34A)相对于绝缘件端面(36A)的中心定位并从该面凸出,所述台肩在横向远离有源电极(34)的深度在0.05L到0.5L之间,L是所述有源电极的暴露的组织治疗部分(34A)的长度。
11.一种包含按照前述任何一个权利要求的器械的电外科系统,其特征在于进一步包括一个用于向上述器械供给射频功率的电手术发生器(10),所述的发生器包括一个输出级,该级至少具有一对可分别连接到所述器械的有源电极(34)和回路电极(38)上的电手术输出连接装置(65),一个用于获得在两个输出连接(62)之间发生的表示峰值射频输出电压的传感信号的传感电路(68),和一个用于当传感信号指示预定的峰值射频输出电压已达到时自动地减少所输送的输出电压的功率调节电路(70)。
12.按照权利要求11所述的系统,特征在于所述功率调节电路(70)当传感信号指示所说的阈值已达到时可操作使所传输的输出功率至少减少50%,所说的减少在100μs或更短的期间内完成。
13.按照权利要求12所述的系统,特征在于功率调节电路(70)可操作来使所说的减少在20μs或更短的期间内完成。
14.按照权利要求11-13中任一个所述的系统,特征在于所述输出级至少包括一个射频功率装置,其中所述控制电路是配置成使在输出电压上至少减少50%是通过减少在对装置供给电压的各个射频振荡周期中的装置导电持续期实现的。
15.按照权利要求14所述的系统,特征在于所述传感电路(68)和功率调节电路(70)是可重复地操作的,以实现功率装置从峰值电平到低谷电平的导电持续期按一周到一周的快速减少,接着是在导电持续期不那么快速地渐进增加,直到导电持续期再达到它的峰值值,快速减少和渐进增加序列是重复的,而且同时减少对所说的输出级供给的电压,直到所说的峰值导电周期值被达到,而输出的电压不会超过所说的阈值。
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GBGB9512889.8A GB9512889D0 (en) | 1995-06-23 | 1995-06-23 | An electrosurgical instrument |
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GBGB9600355.3A GB9600355D0 (en) | 1995-06-23 | 1996-01-09 | Electrosurgical instrument |
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Also Published As
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BR9609421A (pt) | 1999-05-18 |
IL122713A (en) | 2001-04-30 |
CA2224858C (en) | 2006-11-14 |
ES2150676T3 (es) | 2000-12-01 |
EP1025807A2 (en) | 2000-08-09 |
CN1193268A (zh) | 1998-09-16 |
EP0771176A1 (en) | 1997-05-07 |
EP1025807B1 (en) | 2004-12-08 |
US6004319A (en) | 1999-12-21 |
MX9800249A (es) | 1998-07-31 |
DE69609473T2 (de) | 2001-04-26 |
WO1997000647A1 (en) | 1997-01-09 |
DE69609473T3 (de) | 2006-09-28 |
KR100463935B1 (ko) | 2005-05-16 |
JP3798022B2 (ja) | 2006-07-19 |
JPH11507857A (ja) | 1999-07-13 |
DE69634014D1 (de) | 2005-01-13 |
EP0771176B2 (en) | 2006-01-04 |
AR002570A1 (es) | 1998-03-25 |
EP0771176B1 (en) | 2000-07-26 |
AU710619B2 (en) | 1999-09-23 |
DE69634014T2 (de) | 2006-03-02 |
CA2224858A1 (en) | 1997-01-09 |
ES2233239T3 (es) | 2005-06-16 |
KR19990028364A (ko) | 1999-04-15 |
US6056746A (en) | 2000-05-02 |
DE69609473D1 (de) | 2000-08-31 |
EP1025807A3 (en) | 2000-10-04 |
AU6132196A (en) | 1997-01-22 |
IL122713A0 (en) | 1998-08-16 |
ES2150676T5 (es) | 2006-04-16 |
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