CN1209047A - 一种电外科设备及一种电外科电极组件 - Google Patents

一种电外科设备及一种电外科电极组件 Download PDF

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CN1209047A
CN1209047A CN 96180073 CN96180073A CN1209047A CN 1209047 A CN1209047 A CN 1209047A CN 96180073 CN96180073 CN 96180073 CN 96180073 A CN96180073 A CN 96180073A CN 1209047 A CN1209047 A CN 1209047A
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N·M·戈布尔
C·C·O·戈布尔
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Abstract

一种主要是用于所谓的“水下”电外科的电极组件,具有一个射频发生器、一个手柄和一个能可拆卸地安装在所述手柄上的电极组件。可以根据将要进行的外科手术的不同来选择不同的电极组件。为了适应所述发生器的特性以改善电外科手术,每个电极组件都包括一个如具有能被所述发生器检测的特定的电容值的电容器之类的识别元件。在所述发生器中,所检测到的电容值导致对操作参数的选择,优选地是对一个额定的发生器输出功率和一个峰值电压极限的选择,以与所选择的电极组件相适应。

Description

一种电外科设备及一种电外科电极组件
本发明涉及一种具有一产生射频能量的发生器、一手柄及一个可拆卸的电极组件的电外科设备。本发明也包括一个能可拆卸地安装在电外科设备的一个手柄上的电极组件,一个组装及操作所述设备的方法,及一个电外科发生器。
用一个或多个连接到射频发生器上的电极,通过对活体组织施加射频电流以对组织进行脱水、切除或汽化的外科手术在获取从所述发生器到组织的高效率的能量传输方面及以可控制的方式产生所需要的外科手术效果方面存在一些具体的问题。电极组件在使用过程中的电特性很大程度地依赖于使用模式、组织及周围物质的电导率、及电极组件本身的特性。
在通过将一个或多个电极浸入到手术部位的液体中而进行电外科手术的情况下(通常称之为水下电外科手术),这些问题特别明显。
水下外科手术通常利用内窥镜技术来进行,其中(1)所述内窥镜本身可以构成一个能通过一个电极的导管,一般称之为一个工作通道,或(2)所述内窥镜可能特别适于包括用于安装一电极的装置,如在一种前列腺切除器上所提供的,或(3)可通过独立的进出装置相应于所述内窥镜以一个角度将所述电极导入体腔内;这一个技术通常被称为三角法。通过外科特点可以细分这些技术上的不同,其中一种或另一种技术对于为特定的体腔提供进入通道具有特别的优势。当可以通过天然的身体孔进入体腔时,通常使用具有一体工作通道的内窥镜或那些被称作前列腺切除器的装置,如通过宫颈通道可以进入子宫的子宫内膜腔或通过尿道可进入前列腺和膀胱。专门设计用于子宫内膜腔的内窥镜称为子宫镜。用于泌尿道的包括膀胱镜、尿道镜和在经尿道进行前列腺切除或汽化(分别为TURP和EVAP)时所用的前列腺切除器。当没有可供内窥镜通过的天然身体孔时,通常使用所述的三角法技术。三角法通常应用的部位是在水下内窥镜外科手术中用于如膝关节和肩关节之类的关节腔。用于这些手术的内窥镜通常称为关节镜。
在我们递交的两个未决的英国第9512888.0和第9512889.8号专利申请(其公开文件被本文引为参考)中,我们公开了一种电外科发生器和一种为使用浸入一种如盐溶液之类的导电液体中的电极的手术而设计的电极组件。所述电极组件有两个电极,第一个电极是在所述组件的最远端的用于接触被处理的组织的有源电极,而第二个是置于所述有源电极附近的但又通过一种绝缘层与所述有源电极隔离开的返回电极。当将这两个电极浸入盐溶液中时,所述盐溶液在接触所述有源电极的组织与所述邻近的且与所述组织保持隔离的返回电极之间提供一个导电通路。所述电极组件由一个发生器供电,该发生器包括一个快速作用的功率降低电路,该电路工作以防止在进行电外科脱水时在所述有源电极上形成严重的汽化。当峰值输出电压达到一个预设的阈值时,由所述发生器提供给电极组件的输出功率快速降低,其目的是避免在汽化开始时的能量释放以失控的方式迅速增加和产生电弧,它们会在需要脱水的部位导致不可控制的组织分解。当所述发生器有一较大的输出阻抗时这一作用将更成问题。
不同的电极组件可用于实现不同的电外科功能。本发明的一个目的是提供一个电外科设备,它能产生一个可控制的外科效果并且在使用上是灵活的。
根据本发明的第一个方面,提供了一种具有包括一个产生射频能的发生器的第一单元和包括一电极组件的第二单元的电外科设备,所述第二单元被可拆卸地连接到所述第一单元上以使射频能能够传输到所述电极组件上,其中所述第二单元具有一个无源电子识别元件,该元件具有一个代表所述电极组件特征的有限的非零值的参数,而所述第一单元具有一个读出装置,用以在所述第二单元连接到所述第一单元时检测所述参数值,所述发生器具有一个响应于所述读出装置的调节装置,用于调节所述发生器的输出以使其适应于所识别出的电极组件的特性。以这种方式,可将所述发生器配置成自动适合各种不同的电极组件,以使同一发生器能用于不同的电外科手术,使操作者从设置发生器以使其适合所选定的电极组件的繁杂工作中解脱出来。
这在上述的所谓水下电外科手术情况下和在前面提到的两个未决的申请中是特别有用的。申请人已经发现,当进行脱水时所施加的功率水平随电极组件的结构的不同有很大的变化。通过在每个电极组件中具有的一个可识别例如所述组件的汽化功率阈值的识别元件,可将所述组件的特性传送给所述发生器以便据此设定射频输出。因而,当保证用相同的发生器能使用不同的电极组件时,特别是在脱水手术中,是可以实现改进了的控制的。
对于切除和组织汽化,需要使所浸入的液体汽化,但所施加的功率水平不应超过对电极组件造成损坏的水平。可以利用本发明来设置一射频电压极限值,以便通过限制组织汽化的程度来防止超过电极组件的额定功率。
所述第一单元可具有所述的发生器、一个连接器(它可集成在一个设备手柄内)和一个连接所述发生器与所述连接器的导线。在这种情况下,所述第二单元可由电极组件构成,其中组件本身具有一个与所述第一单元的连接器相匹配的连接器,因而提供了一个可卸下的机械接口。
可选地,所述第一单元可包括一个具有一个第一连接器的发生器,而第二单元具有所述电极组件、一个第二连接器和一个将所述第二连接器与所述电极组件相连接的导线的组合,以便将所述机械接口提供于所述发生器上。在这种情况下,可以将所述电极组件可拆卸地或不可拆卸地安装在一个手柄中或安装在一个构成所述第二单元一部分的外壳中。
在两种配置中,所述机械接口可提供进一步的装置根据连接于发生器上的所述元件对所述发生器进行控制或调节。特别地,所述接口可具有一种特定的插头和插座组合,其中插头和插座都做成分别不能被其它不同插座或插头所使用的形状。因而不同的插头和插座组合可提供给不同的外科应用场合。例如,第一个组合可用于子宫镜系统,另一个组合则用于关节镜应用,等等。
据此,如果发生器具有一个例如标明为用于子宫镜手术的插座,则所述发生器电路被设计为向该插座提供适合于这一手术的输出信号。另外,如果一个发生器具有一个标明为用于关节镜手术的插座,则所述发生器电路向该插座提供的输出信号更适合于关节镜手术。可以为每一类手术规定一个电极组件的范围,并且可这样设置所述发生器,使得用于一类手术中的电极组件中的电子识别元件使所述发生器的输出不同于用于不同类的手术的电极组件中的相同识别元件组使所述发生器产生的输出。实际上,将所述发生器设置成能提供根据与输出信号所输向的插座的形式有关的所述识别元件进行调节的信号。以这种方式,将不同信号输出的应用范围扩展,不仅限于根据所述识别元件的值来简单调节所述的输出。
就此而论,根据本发明的优选设备能在第一和第二单元之间提供一个机械接口,所述接口是由一个插头和插座构成的,该插头和插座分别具有从许多不同形状中选出的相互匹配的构形,以使所述第一单元和第二单元只有在他们具有这种相互匹配的插头和插座形状时才能可操作地安装在一起。
更确切地说,在根据本发明的一种优选的电外科设备中,所述第一单元具有一个向所述第二单元输送输出信号的输出连接器,所述输出连接器的构形对输出信号所适合的外科领域是特制的。所述第二单元具有一个接收来自于所述发生器的输出信号的输入连接器并将这些信号提供给电极组件,所述输入连接器的构形对所述电极组件所适合的外科领域是特制的。所述输入连接器的构形和所述输出连接器的构形形成一个相互匹配的组合,以使只有在用于所述的连接器上的所述电极组件和所述输出信号都适合于同一外科领域时所述电极组件和所述发生器才是可通用的。
所述读出装置和所述调节装置响应于所述识别元件的方式与所述输出连接器的构形有关。
因此,可以根据所用的内窥镜的形式及所用的外科手术的形式来优化电极的构形和对应的电外科输出。可以将包括特制的电极组件、发生器和在电外科发生器与所选的电极组件之间的连接器装置的系统划分为关节镜系统、子宫镜系统或泌尿科内窥镜系统,针对每个特定的部分都采用一种独有的导线/插头组件。
关节镜电极的特点是较短(100至140毫米)、较硬,其工作直径可达4毫米。采用所述三角形技术借助于套管或不借助于套管通过一个穿刺切口将它们插入关节腔中。被治疗的组织通常是质密的且具有较高的电阻抗,如半月板软骨之类。除电极的直径小于手术刀因而改善了入口性能以外,输出功率和电压的设置都考虑到了组织的形式、电极的尺寸以及关节镜医师们都在追求与他们现在所用的机械切除器仪器相比作用速度要快这一事实。因而关节镜电极组件设计需要支持相对高输出的要求,形成高阻抗组织的快速去膨胀(debulking)并且必须结合人机控制手柄来帮助进行组织处理。然后,在所述关节镜系统中,可将所述电极组件识别的范围细分为关节镜电极组件识别以及根据这些规格和外科技术设定的发生器系统设置。
子宫镜电极的特性为较长(350-400毫米)、可弯曲或半刚性的,其工作直径一般在1.27-2.86毫米范围内(4-9号)。它们可通过一个工作通道插入。子宫镜工作的组织通常比关节镜外科所涉及的组织具有更多的血管,并且由于疏忽造成的子宫穿孔是一种严重的并发症。因而需要用比在关节镜手术中所用的常规方式更为精确的电极或子宫镜运动来支持一个更为可控制的有良好的脱水能力的电极应用。电极组件至发生器的接口不需要一个真正的“手柄”可以仅仅构成一个连接器装置。因而在所述子宫镜系统中,可将电极识别的范围不同地细分为子宫镜电极识别和根据这些规格和外科技术设定的发生器系统设置。
主要有两种用于内窥镜泌尿手术的电极构形:(1)膀胱镜/尿道镜电极,和(2)前列腺切除器电极。前者的特性与子宫镜电极十分相似,是通过泌尿系统的内窥镜工作通道插入的。前列腺切除器电极的插入方式很不相同,在将组装好的设备通过一个经尿道引入的工作鞘套插入之前,就将它们安装在一内窥镜上。所述电极的近端与一个触发器组件相连并且整体上与前列腺切除镜接触。用这种方式,通过操作所述触发器机构可将所述电极在一定运动范围内向前或向后移动。由于电极是在插入之前组装成的,所以其头部的大小不受工作通道尺寸的限制,而是受所述工作鞘套的限制。所述工作鞘套的直径范围可达10毫米。这一直径的一部分是由电极的支撑铁丝占据,根据内窥镜的图象,所述支撑铁丝通常以一个向下的角度弯向工作头,以使它们既不妨碍观察又不妨碍操作。但是,一个典型的滚轴电极的宽度可以在3-4毫米范围内,且直径可以在2-3毫米范围内。当必须消除平均重量在20-30克的前列腺组织时,电极需要有这样的尺寸。作为纤维和腺体的混合物,所述组织可能有不定的密度,它的一些区域可能有较多的血管。因而需要同时进行脱水和汽化的综合作用。泌尿科电极的滚轴形状需要一个高功率高电压的发生器输出。因而在泌尿系统中,可将电极识别的范围细分到由泌尿内窥镜电极组件识别和根据这些规格及外科技术的系统设置组成的另一个组中。
除了对上述水下外科领域的电极组件识别的划分之外,还可针对专门工作在含盐工作环境中(限于电极头部)的电极组件对发生器的设置作进一步的细分。这样,这个电极组件设计显著提高了系统在外科手术中的通用性,所述外科手术既可在暴露于空气进行也可在汽体膨胀之下进行。前者可在直接可见的情况下进行,以去膨胀、切下或凝结一组织群或如消除椎间盘突出或从身体窦中消除发病组织等所进行的手术那样通过一个三角法的内窥镜实现,即所谓功能性内窥镜身体窦外科术。汽体膨胀技术的例子包括腹腔镜和胃肠镜外科术。因而,其电极识别的范围可细分到由盐促进的电极识别和根据这些规格及外科技术设定的系统设置组成的另一个组中。
上面已经从完整的装置方面描述了本发明的几种变化形式。现在介绍本发明的其它方面。可以理解,上述的几种变化形式可类似地应用。
根据本发明的第二个方面--一种电外科设备用的电极组件,该组件具有至少一个电极、将所述组件可拆卸地安装在所述设备的另一部分上的安装装置和一个配置成与读出装置相互作用的无源电子识别元件,所述读出装置与所述设备的其它部分有关,所述识别元件具有能代表所述组件的非零确定值参数。
所述识别元件最好是一个如分立电容器之类的预定阻抗的无源元件,所述阻抗可以代表上述的电极组件特性。优选地,在所述元件为一电容器情况下,根据组件的功率水平阈值,电容值随电极组件的不同通常在15pF至1μF的范围内变化。在电极组件将用于浸入性液体的情况下,所述阈值将是使汽化能正常产生的值,最好是随着功率阈值的增加而增加电容值。
电极组件安装装置可包括至少一对电触点,用于与设备手柄中的电触点接合,所述电容器被连接在所述电极组件的电触点之间,以便当所述电极组件被安装在所述手柄上时,其触点与手柄上的相应位置上的电触点相接合,手柄上的电触点与发生器中的读出电路是相连的。
在优选实施例中,所述识别元件连接在一个识别触点与一个用于在所述发生器与所述电极组件之间传导射频电流的触点之间。在一双极设备中,一般有三个触点,两个用于传导射频电流,一个用于电极组件的识别。根据用于系统中的不同识别参数值的数量和发生器读出装置所能够分辨的内容,一种单个识别触点设计可用于识别三个或更多个不同的电极组件。
关于所述发生器,根据本发明的第三个方面,一个可与多个不同的电极组件一同使用的电外科发生器包括具有代表着这些电极组件的特性的不同的有限非零参数值的相应的电识别元件,其中所述发生器包括响应于所述参数值的读出装置和根据所示出的连接于所述发生器的电极组件的特性自动设置发生器的输出的装置。
在一个优选实施例中,所述识别元件为一电容器,而所述读出装置包括一个电感形式的电抗性元件,当所述电极组件与所述发生器相连时,所述电抗性元件与所述识别电容器形成一个谐振回路,所述谐振回路的谐振频率与所述电容的值有关。所述读出装置也可包括一个振荡器,例如一个适当连接的晶体管,与所述谐振回路形成一个自激振荡电路部分,以使将振荡频率确定为所述谐振回路的谐振频率。在这种情况下,所述振荡器频率将代表所述电极组件的特性。
可选地,所述读出装置可包括一个可调的内部电容或电感,具有切换不同电感或电容值的装置,或具有调整所述的电感或电容值直至找到在预定的固定频率上产生谐振的一种电感、电容组合为止的装置。
在所述读出装置中的所述电感可具有一个隔离变压器的第一绕组,这一绕组与在一连接器中的或在一设备手柄中的一对触点连接,这些触点通过所述识别电容搭桥而与所述电极组件上的触点相接合,以便在所述电极组件被连接到所述发生器上时形成谐振回路。所述变压器的第二绕组一般以一个为所述振荡器提供反馈的检测绕组的方式优选地形成所述振荡器的一部分。所述变压器可具有与所述振荡器的输出端相连接的一个第三、激励绕组。可选地,可提供一个第二变压器,它具有一个与所述振荡器的输出端相连接的第一绕组以起到激励绕组的作用,还具有一个当所述电极组件被连接到所述发生器上时以串联的方式连接在所述谐振回路中的第二绕组。在这种情况下,分别来自于一个变压器的两个变压器绕组构成了与所述电极组件中的识别电容相谐振的所述电感。
在如上所描述的具有一有源电极和一个返回电极的电极组件中,可用三个电触点通过将所述有源电极与一个触点连接、将所述返回电极与另一触点连接、将所述电容器与第三个触点连接、而将电容器的另一端连接到属于所述几个电极的这些触点中的一个上,来实现电极组件的识别功能。所述电容器可是很小的并可快速地安装在触点盒中的所述触点的末端,该触点盒的形状利于被接收进连接器或手柄中或被接收在连接器或手柄上,所述连接器或手柄则与所述发生器相连。
在所述发生器中,所述读出装置可与以一个控制器形式的调节装置相连接,所述控制器用于根据由所述读出装置提供的输出信号和所述识别特性的表示式来设置所述发生器的输出功率。所述控制器最好是能响应于所述读出装置的输出信号可操作地调节供给射频输出电路(本例中为功率振荡器)的平均电源电压。在发生器具有一个开关式电源的情况下,所述控制器被连接到电源上并用于相应于所述读出装置的输出信号调节所述电源的开关输出的占空系数。
本发明可用于发生器与设备手柄分离或发生器安装在设备手柄中的设备中。不管所述发生器是否在手柄中,所述读出装置都可安装在所述手柄中。
根据本发明的第四个方面,提供了一个组装和操作一个电外科设备的方法,包括:提供一个具有一个用于产生射频功率的电外科发生器的第一单元;提供多个具有不同电极组件的第二单元,每个第二单元都具有用于可拆卸地安装在所述第一单元上的装置及具有一个有代表相应的电极组件特性的有限非零值参数的电识别元件;选择所述第二单元中的一个并将其安装到所述第一单元上;并且在第一单元中,检测所述识别元件参数值并相应于所述的检测自动调节所述发生器输出以与所选定的第二单元的电极组件的特性相适应。
根据本发明的第五个方面,本发明包括一套用于组装一电外科设备的零件,具有一个包括一用于产生射频电外科电压的电外科发生器的第一单元,和多个具有不同电极组件的不同的第二单元,每个第二单元都具有用于安装到所述第一单元上的装置,其中每个第二单元都具有一个有从一确定非零值范围中选出的并代表相应的电极组件特性的相应值的参数的电识别元件,并且所述第一单元具有用于当所述第二单元被安装在所述第一单元上时检测所识别出的参数的装置,所述发生器具有响应于所述读出装置以调节所述发生器的输出的调节装置,借此当第二单元被根据所检测到的参数值选择性地安装在所述第一单元中时使所述发生器的输出被自动调节到与所述第二单元的电极组件的不同特性相适应。
现在参照附图以实施例的方式对本发明进行描述,其中,
图1为表示用于泌尿科手术的,特别用于膀胱镜手术的电外科设备的示意图,其中部分地以剖面图方式示出了电极组件和手柄,而以方块图形式示出了一个发生器;
图1A部分地以纵向剖面图的方式更详细地示出了图1中的电极组件的末端;
图2是一个电极组件和一个识别电路的电路图,后者形成图1中所述发生器的一部分;
图3是一个电极组件和一个可选的识别电路的电路图;
图4是一个用于子宫镜手术的电外科设备的一个电极组件和连接器单元的侧面图,所示出的电极组件和连接器单元尚未被安装在一起;
图5是一个用于关节镜手术的电外科设备的一个电极组件和手柄的局部剖视的侧视图;及
图6A、6B和6C分别是图1、图4和图5中的泌尿、子宫镜和关节镜设备的电极组件的局部侧视图,示出了这些组件的插头部分之间的差别。
参照图1和图1A,根据本发明的一个电外科设备包括一个用于产生射频功率的发生器10、一个铅笔柄状的手柄12,在图1中部分地以剖面形式示出,以及一个可拆卸的电极组件14,在图1中与所述手柄12拆开地但与手柄上的孔16排成一线地示出,这个孔用于接收所述电极组件14的插头部分18。在本发明的这个实施例中,所述发生器10是与所述手柄12分离的,它们两个通过电缆线20和一个输出连接器21相连接,如图所示。
在我们递交的未决的英国第9512889.8号专利申请中对所述电极组件的结构进行了一般的描述。在图1中没有示出所述电极组件的末端,但在图1A中放大地示出了这一部分。所述电极组件具有一个以一个被一绝缘鞘22S包围着的导电管22T的形式形成的长杆22。在长杆22的远端有一个暴露的中央组织触点或有源电极24。这是一个与一个延伸成中心导线26的金属导线相连接的半球形的金属头,所述中心导线贯穿整个长杆22连接到位于组件14近端的插头部分18上的一个第一触点28A上。围绕在中心电极24周围的是一层绝缘套管30,其末端靠近所述有源电极24的暴露部分,并且也是暴露的。围绕在所述套管16周围的是以金属管的形式形成的同轴的返回电极32,它与所述长杆22的金属管状主体22T在电和机械两个方面都连成一体。所述返回电极32与所述电极组件14的插头部分18上的第二触点28B相连接。为了使其与所述有源电极24在径向和轴向上都隔离开,所述返回电极32将终止在比套管30短的点上。在正常情况下,只有有源电极24接触被治疗组织;所述返回电极32被浸入一种如盐溶液之类的导电溶液中以在所述有源电极24周围的组织与所述返回电极32之间形成电传导通路。
电极组件插头部分18被固定在一塑料外壳33中,该外壳也支撑着所述长杆22。这个外壳33具有一个同轴地围绕在所述插头部分18周围的凸台33B,和一个朝侧向伸出的凸键部分33K。一个可旋转的卡销环31将所述外壳33固定在所述手柄12上。
所述外壳33包含有分立无源电子元件,在这种情况下,其形式为将一个小电容器34的一端连接到所述导电管22T,另一端形成一个暴露在所述外壳的凸键部分33K的近端表面上的第三触点。
当电极组件14被固定在手柄12上时,插头部分18通过孔16进入内壳腔35中,内壳腔35中有弹簧电触点36A、36B分别与电极组件插头部分18的触点28A、28B相接合。孔16上连有一个凹孔,其形状与电极组件外壳33的凸台33B和凸键部分33K的外形轮廓相匹配,并具有一个第三触点33C,它装有弹簧,并位于凹孔37中以与电容器34的暴露端相接合。
36A至36C这三个触点中的每一个都在手柄12中被分别连接到电缆20的导线38A、38B和38C上。在这种情况下,电缆线20具有两个另外的导线(未示出),用于连接位于手柄体内的按键式开关39。
可提供几个不同的电极组件,每一个都具有与手柄12相适应的一个插头部分18和一个外壳33,并且每个都具有一个识别元件(电容器34),其值对每一个相应的电极组件是特有的,以使在触点28A和电容器34的暴露端之间的电容能够标识出相应的电极组件。不同电极组件的优选例子见我们递交的未决的英国第9600352.0、9600354.6、9600355.3、9600356.1和第9600377.7号专利申请,其内容被本文引为参考。
通过一个发生器输出连接器组件21将所述电缆线20连接到发生器10上,对于要接收所述发生器的输出的各种外科手术,在本例中为泌尿科手术,都有其独有的连接器组件。
现在参照如图1中所示的发生器10的各组成部分,射频(RF)功率振荡器40具有一对通过连接器21与电缆线20中的导线38A和38B相连接的、并从这里分别连接到所述电极组件14的有源电极24和返回电极32上的输出端40C。通过一个连接到所述振荡器40上的开关式电源42为振荡器供电。在这个优选实施例中,所述振荡器以大约400KHz的频率工作,从300KHz至HF频段范围内的任何频率都是可行的。所述开关式电源通常以25至50KHz范围内的频率工作。与输出端40C并联的是一个电压阈值检测器44,该阈值检测器44具有一个连接到所述开关式电源42的第一输出44A和一个连接到一个控制电路的一个接通持续时间控制部分46的第二输出44B。另外,所述控制电路的控制器部分48被连接到电源42的一个控制输入端42A上及被连接到所述电压阈值检测器44的一个阈值设定输入端44C上,所述控制部分48最好是以一个连接到操作者控制器和一个显示器(未示出)上的微处理器控制器形式构成。
所述“接通”时间控制电路46被连接到所述射频振荡器40上以在每一个射频振荡周期中控制所述振荡器40的振荡输出装置的导通时间,从而控制施加到所述电极组件14上的功率。
所述发生器10还包括一个具有输入端50A和50B的电极识别电路50,所述输入端50A和50B分别连接到手柄12上的触点36B和36C上,以便当电极组件被安装在手柄12上时,电极组件中的电容器34被并联在所述电极识别电路50的输入端上。这个电路50具有一个连接到所述控制器48的一个输入端上的输出50C。
在操作中,当需要电外科功率时,由外科医生操作手柄12上的起动开关39中的一个开关,则所述控制器48通过所述开关式电源42将电能提供给所述振荡器50。根据在所述发生器10的前面板(未示出)上的控制设置通过输入44C来设定一个输出电压阈值。一般地,在用于脱水时,将所述阈值设在150至200伏之间的一个脱水阈值上。当需要一个切除或汽化输出时,将所述阈值设在250至600伏范围内的一个值上,所述值与电极组件14中的电容器34的电容值有关,由所述电极识别电路50的在输出端50C所产生的输出信号来表示。上面给出的电压值是峰值电压。这意味着,至少在脱水时,最好具有一个低峰值因子的输出射频波形,以使得在电压被钳制在给定值上之前提供出一个最大的功率。通常1.5或更小的峰值因子是可实现的。
当所述发生器被首次起动时,连接到所述控制电路的“接通”时间控制部分46上的振荡器40的控制输入40I的状态是“接通”,这样使得构成振荡器40的振荡零件的功率开关装置在每个振荡周期中被接通达最大传导时间之久。施加到电极组件14上的功率部分地与通过开关式电源42作用到所述射频振荡器40上的电源电压有关,部分地与负载阻抗有关。所述开关式电源42产生电源电压,该电源电压与由控制器48加在其输入42A上的“功率”信号有关,控制器48进而与前面板的设置及所选用的电极组件14中的电容器34的电容值有关。
如果由开关式电源42提供给振荡器40的电源电压足够高,则电极24和32周围的液体媒质的温度将升高到一定程度,使其得以汽化,导致负载阻抗快速升高及由此造成的所施加的并联在所述振荡器40的40C端的输出电压的快速升高。如果需要的是一个脱水输出,则上述状态是一个不良的工作状态。因此,脱水输出的阈值电压被设置成能在达到所述阈值时产生发送给所述“接通”时间控制电路46及所述开关式电源的触发信号。所述“接通”时间控制电路46实际上具有即时地降低所述射频振荡器控制装置的所述“接通”时间的作用,并且同时通过所述检测器44的输出44A使所述开关式电源停止工作以使供给所述振荡器40的电源开始下降。
接下来,所述振荡器10的每个周期的“接通”时间将被进一步增加直至所述输出电压阈值被又一次突破,导致另一个“接通”时间的即时降低。当电源电压降低时,振荡器的“接通”时间下降的时期可以针对一个给定的所施放的输出功率而缩短,因此,如果需要的话,可以与前面所描述的相同的方法获得进一步的即时功率减少。在上面提到的第9512888.0号英国申请中对实现这一过程的方式进行了描述。
能以足够快的速度动态地控制所述输出电压并使其达到一个足以使施放功率保持在一个适于脱水的水平的程度的所述控制电路46、48的操作,也可以被用于组织切除或汽化模式,但要用一个不同的阈值电压来动态地限制输出电压以防止电极过热和/或过度地组织汽化。在后一种情况下,电压限制应根据电容器34的电容值(图1)设在250伏至600伏之间的一个水平上。
可以根据所述电极组件14中的电容器34的值用所述电极识别电路50和所述控制器48中的调节装置来调节所述射频振荡器40的初始功率水平和汽化模式下的所述阈值电压。因而,电压超调和因此造成的在所述脱水模式中不愿有的汽化可以被很容易地避免。这对于在切割或汽化之前通过脱水来封闭血管是至关重要的。相似地,在汽化模式中,可根据所述电极组件自动设定一个额定的功率水平,以施放一个实现汽化所需要的最小的功率水平。同样是在汽化模式中,可以设定其最大功率水平,因而确定由连接到手柄上的特定的电极组件所产生的汽化凹穴的尺寸。所述汽化凹穴的尺寸则决定了被消除的临近电极的组织的数量。然而,操作电压越高,所引起的有源电极的温度则会越高。因而,如果所述有源电极是由一种贵重金属制成的,则它能比由不坚固的金属制成的电极耐受更高的电压。在这种条件下,电极将可能过度腐蚀或熔化,而所述电容器34可用于在汽化模式中设定所述电压阈值检测器来防止这种情况的发生。
就调节所述振荡器的功率水平而言,所述电容器34用于传递所述电极组件14的标识,并由此将相应电极组件14的适当的功率水平传递给所述发生器。所述发生器可具有一个200瓦的最大功率水平及一个使所述组件可以进行汽化所需要的最小功率水平,这一水平可能低至30瓦。为实现适合不同电极组件的功率水平的近似对数刻度,可用不同电容器值来代表如30、45、70、100及150瓦的功率水平。一个可选的对数刻度为30、42、58、80、110和150瓦。可用15pF至1μF之间的电容器值来代表这些功率水平。如果这些值相应于功率阈值,则对于脱水模式,所述控制器被用于将功率设置在稍稍低于相应值的水平上,而对于汽化,所述设定值要稍稍高一些。
如果需要的话,也可利用另一个电容值或者通过在电极组件中所安插的一个第二识别元件、一个第四组触点和所述电缆线20中的另一条导线来传递汽化用的电压最大值。
优选地,电极组件的额定功率越大则电容器34的值越大。这样做是考虑到所述设备的电极识别部分有可能失效,且所述发生器可能不能达到为安全目的而设定的最小功率和电压。
根据安装在手柄上的电极组件设定额定功率水平的一个优点是功率能以一个额定的水平快速地提供给所述组件,而不是在电极被首次用于被治疗的组织上时逐渐地升高到那个水平。以不同方式来看,外科医生可从起点开始施加所需要的功率水平,可很好地降低电极损坏的危险和不希望的组织破坏。
现在参照图2和图3来详细描述所述电极识别电路。
所述电极识别电路50的中心是一个具有驱动一个隔离变压器54的一个初级激励绕组54A的一个低阻抗输出52A的运算放大器52。所述变压器54的一个次级绕组54S被并连到所述电路50的输入端50A和50B上以使绕组54S和所述电极组件的电容器34形成一个并行的谐振电路。所述谐振电路的谐振频率通常在2kHz至150kHz的范围内,与电容34的值有关。
所述变压器54还具有一个连接在位于一边的交流地与所述运算放大器53的反相输入端52I之间的检测绕组54B,因而形成一个来自于所述变压器的反馈回路。由于绕组54B通过所述次级谐振绕组54S与所述激励绕组54A有效地耦合,所以谐振电路的存在大大地滤除了所述运算放大器52输出的方波中的谐波。
极性相反地并联连在检测绕组54B上的钳位二极管D1和D2与电容器C3及电阻R4一起构成了一个相对于所述激励绕组的输出产生90度相位滞后的移相网络。所述二极管还针对从所述发生器的射频输出接收到的通过导线38A和38B施加的过高的射频电压提供了一个保护。
所述变压器54的三个绕组54A、54B和54S被绕在一个具有一个中心螺纹的铁粉心54C的三面绕线管上,选定铁粉材料是因为它具有高居里点和因此而来的小的温度漂移。可选地,铁心54也可由亚铁盐材料制成,它具有一个比较大的Al值,与校准参量结合,通过例如将一个已知的电容并联接在所述谐振绕组54S的方式来对温度漂移进行补偿。
所述次级谐振绕组54S与变压器54的其它绕组54A、54B之间的耦合是比较低的,以限制射频反馈。一般地,漏感值在3mH左右。
从上文中可以认识到,运算放大器52起着一个振荡器的作用,以由次级绕组54S和电容器34所产生的所述谐振电路的谐振频率振荡。由所述运算放大器52产生的输出信号在一个缓冲放大器56中被放大并施加到输出端50C,从那里它被反馈给所述控制器48(见图1)。控制器48包括一个用于确定振荡频率的计数器或一个相当的设备,用其来得到电极组件的标识。
作为一种安全特性,所述控制器48包括根据来自于所述识别电路50的输出来确定是否没有电极被接到所述手柄12之上的装置。在这类偶发事件中,所述电路50的振荡频率将超出预定范围(在这个实施例中为高于150kHz)并且所述调节装置将产生一个表示没有电极组件被连接上的信号,并将禁止向所述手柄12施加射频输出功率。
在一个可选实施例中,如图3所示,电极识别电路50具有二个隔离变压器60和62,以防止在一方面与所述运算放大器的输出端52A相耦合的一个激励绕组60A与在另一方面与所述运算放大器的非反相输入端52I相耦合的一个检测绕组62A之间产生磁耦合。两个变压器的次级绕组60S和62S被串连起来,它们的综合电感与电极组件电容器34形成一个并联的谐振电路。与图2中的电路相比较,作为双变压器组合的结果,没有了磁耦合,这样便减少了谐波向所述振荡器的反馈回路中的传播。因而,施加到激励绕组60A中的所有能量都被以这种方式滤波,以使只有经过滤波的能量才能到达所述检测绕组62A。
在这个实施例中,另外的两个二极管D3和D4被用于对运算放大器52进行钳位和保护,以防止对所述第三导线50B产生意外的射频输入(例如,由于用错了电极组件和手柄或由于隔离失效)。
在另一方面,图3的识别电路与图2的识别电路相同。
在上述的详细描述中我们已经运用了对泌尿外科手术特别是适用于膀胱镜手术的电外科设备的例子。本发明可同样应用于如子宫镜手术和关节镜手术之类的其它领域的电外科设备。
图4示出了用于子宫镜的设备的一部分。在这种情况下,一个电极组件14(它可具有一个与图1A所示的相似的电极构形)具有与图1的泌尿科设备十分相似的一个插头部分18和一个外壳33。如在所述泌尿科设备中一样,电容器34(这里以虚线表示)置于所述外壳33的一个侧向凸出的凸键部分33K内,以与一个在连接器单元70中的与电缆线20相连的类似于图1中的触点36C的装有弹簧的触点相接触。
连接器单元70通常连接到一内窥镜的外面(未示出)。参照图5,一个关节镜用的设备具有一个进行过人机工程学设计以帮助进行组织处理的手柄12。注意到手柄12和电极组件14之间的配合,这些部分具有与参照图1所描述的泌尿外科设备的特征相似的特征。
通过比较图1、图4和图5中所示的设备的电极组件14和手柄12及连接器单元70,可以见到它们各自的插头部分18长度不同。在每个例子中,接收器35具有用于与插头部分18的触点28A和28B相接合的触点36A和36B,它们的位置根据相应电极组件插头部分18的长度而定。在分别示出泌尿科用的、子宫镜用的和关节镜用的电极组件的图6A、6B和图6C中更清楚地示出了这些不同。在这三个图中都示出了用于与电容器34的所述端接合的装有弹簧的触点36C。另外,在图6B和6C中示意出了档板74。它用于限制插头部分18的插入,并在这些设备中实际上通常由在接收器35中的横向定位板来提供。
应注意到,尽管在所述插头单元18尾部的触点28A的长度c和绝缘隔离部分29的长度b在全部三个实施例中都保持一致,但外壳33与绝缘隔离部分29之间的距离a在每一例中都不同。每个特性组中的所有电极组件的尺寸都保持一致。因而,适用于泌尿科手术的所有电极组件都具有相对长的插头部分18,适用于子宫镜手术的所有电极组件都具有较短的插头部分18,而适用于关节镜手术的所有电极组件都具有中等长的插头部分18,如图6A、6B和6C所示。所以,每个电极组件只能与专门用于同一特性组的手柄12和连接器单元70一同使用。如果在一电极组件和一个手柄或连接器单元之间出现机械接口不匹配,则由于触点28A、28B中的一个或两个不能与手柄中或连接器单元中的相应触点接触,或由于所述装有弹簧的触点36C不能与外壳33中的所述识别电容器34接合,所以电外科能量就不能从所述发生器施加到电极上。
通过在所述连接器21上提供相似的接口限制(见图1),可以保证每个电极组件只能用于一个为该电极组件的特性组所形成的发生器输出连接。结果,根据特性组可不同地设置发生器,并使其不同地响应于该特性组中的电极组件范围内的不同的识别电容器的电容值。这意味着可通过完全依赖于电容器34的一个有限的取值范围来获得比原本可能的范围更宽范围的发生器设定。

Claims (29)

1.一种电外科设备,具有一个包括一个用于产生射频功率的发生器的第一单元,及一个包括一电极组件的第二单元,所述第二单元能可拆卸地连接到所述第一单元上以使射频功率能被传送到所述电极组件,其中所述第二单元包括一个具有一个能代表所述电极组件特性的有限非零值参数的无源电识别元件,所述第一单元包括一个读出装置,用于在所述第二单元被连接到所述第一单元上时读出所述参数值,所述发生器包括一个调节装置,用于响应于所述读出装置调节所述发生器的输出以使其适应于所识别出的电极组件特性。
2.根据权利要求1的一种设备,其特征在于所述参数是电阻抗,并且当所述第二单元被连接到所述第一单元时所述读出装置与所述识别元件电耦合并可用于产生一电输出信号,该电信号的特性与所述识别元件的阻抗有关。
3.根据权利要求2的一种设备,其特征在于所述读出装置包括一个电抗性元件,当所述第二单元被连接到所述第一单元时,所述的电抗性元件与所述识别元件构成一谐振电路,所述谐振电路的谐振频率与所述识别元件的电抗有关。
4.根据权利要求3的一种设备,其特征在于所述读出装置和所述识别元件一起形成一个振荡器,所述振荡器的工作频率与所述识别元件的电抗有关。
5.根据权利要求2至4中任意一个的一种设备,其特征在于所述识别元件是一个电容器,所述电容器的电容值代表着所述电极组件的特性。
6.根据权利要求3或4的一种设备,其特征在于所述识别元件是一个电容器,所述电抗元件包括一个变压器的第一绕组,所述电容被连接到所述第二单元上的第一对触点之间,所述变压器的第一绕组被连接到所述第一单元的第二对触点之间,所述第一和第二对触点的定位使得当所述第一单元被连接到所述第二单元时,其中一对触点能够与另一对相应的触点相接合以形成所述的谐振电路。
7.根据权利要求4或6的一种设备,其特征在于所述变压器是一个隔离变压器并具有一个形成所述振荡器的一部分的第二绕组。
8.根据权利要求7的一种设备,其特征在于所述变压器具有一个与所述振荡器的一个振荡装置相耦合的第三绕组,所述的第三绕组还构成所述谐振电路的激励绕组。
9.根据权利要求7的一种设备,包括一个第二变压器,所述的第二变压器具有与所述振荡器的一个振荡装置相耦合并做为所述谐振电路的激励绕组的第一绕组,以及一个串联于所述谐振电路中的第二绕组。
10.根据权利要求6至9中任意一个的一种设备,其特征在于所述第一和第二对触点中的每一对触点中的每一个还作为在所述发生器与所述电极组件之间传导射频电外科电流的触点来使用。
11.根据上述任一个权利要求的一种设备,其特征在于所述读出装置响应于所述参数的多个不同值,所述调节装置具有一个用于根据由所述读出装置提供的一个输出信号和所述识别元件参数的表示值来设置所述发生器的输出功率的控制器。
12.根据权利要求11的一种设备,其特征在于所述控制器能根据所述读出装置的输出信号来调节提供给所述发生器的射频输出电路的平均电源电压。
13.根据权利要求12的一种设备,其特征在于所述发生器包括一个开关式电源,所述控制器被连接到所述电源上并能根据所述读出装置的输出信号来调节所述开关输出的占空系数。
14.根据权利要求2至10中任意一个的一种设备,其特征在于第一单元具有所述的发生器、一个连接器和一个用于将所述发生器连接到所述连接器的电缆线,所述电缆线包括用于将所述识别元件连接到所述读出装置的导线,第二单元的形式为一个包括一个与所述第一单元的连接器相匹配的连接器的电极组件。
15.根据权利要求14的一种设备,其特征在于所述的第一单元的所述连接器被装设在所述设备的手柄中。
16.根据上述任一个权利要求的一种设备,其特征在于所述调节装置包括一个用于设置一个用于组织汽化的发生器输出电压极限的电路,所述极限是根据所述识别元件特性来确定的。
17.一种用于电外科设备的电极组件,所述组件包括至少一个电极、一个用于可拆卸地将所述组件安装到所述设备的另外一个部分的安装装置,和一个用于同与所述设备的其它部分有关的读出装置相互作用的无源电识别元件,所述识别元件具有一个代表所述组件的一个有限的非零值参数。
18.根据权利要求17的一种电极组件,其特征在于所述的参数为电阻抗。
19.根据权利要求18的一种电极组件,其特征在于所述的元件为一个电容器,所述电容器的电容值代表所述的组件,所述安装装置包括一对用于与所述的设备手柄的所述其它部分中的电触点相接合的电触点,所述电容器被连接在所述电极的这些触点之间。
20.根据权利要求17至19中的任意一个的一种电极组件,其特征在于所述的电极组件可用于一种导电液体中并具有一个处在所述组件的远端的第一、有源电极和一个与所述有源电极距离很近的第二、返回电极。
21.一种用于多个不同的电极组件的电外科发生器,所述不同的电极组件各自包括具有能代表所述电极组件特性的不同的有限非零值参数的电识别元件,其中所述发生器包括响应于所述参数值的读出装置,和根据所识别出的连接在所述发生器上的电极组件的特性来自动设置所述发生器的输出的装置。
22.一种根据权利要求21的发生器,其特征在于所述读出装置可用于产生一个电输出信号,该输出信号的特性与一个无源电子元件形式的识别元件的阻抗有关。
23.一种根据权利要求22的发生器,其特征在于所述自动设置装置具有一个用于设定发生器的至少一个输出功率和一个最大峰值输出电压的控制器。
24.一种组装和操作一个电外科设备的方法,包括:
提供一个包括一个用于产生射频功率的电外科发生器的第一单元;
提供多个包括不同电极组件的第二单元,所述每个第二单元都具有用于可拆卸地连接到所述第一单元上的装置,并且每个所述第二单元都包括一个具有一个能代表相应电极组件特性的有限非零值参数的电识别元件;
选择所述第二单元中的一个并将其安装到所述第一单元上;及
在所述第一单元中,检测所述识别元件的参数值并根据所述的检测来自动调节所述发生器的输出以适应所选择的第二单元的电极组件的特性。
25.一种根据权利要求24的方法,其特征在于所述发生器的额定输出功率是根据所检测的识别参数值自动调节的。
26.一种根据权利要求24或25的方法,其特征在于一种组织汽化极限电压是根据所检测的识别参数值自动调节的。
27.一种根据权利要求24的方法,其特征在于根据与外科手术的种类相应的所述识别元件参数值来调节所述发生器输出的一个特性,所述外科手术的种类是用所述电极组件所连接的发生器输出连接器的机械构形来区分的。
28.一套用于组装一电外科设备的零件,具有一个包括一用于产生射频电外科电压的电外科发生器的第一单元,和多个具有不同电极组件的第二单元,每个第二单元都具有能安装到所述第一单元上的装置,其特征在于每个第二单元都具有一个电识别元件,所述的电识别元件具有从一有限非零值范围中选出的并代表相应的电极组件特性的相应值的参数,并且所述第一单元具有用于在所述第二单元被安装在所述第一单元上时检测所识别出的参数的装置,所述发生器具有响应于所述读出装置以调节所述发生器的输出的调节装置,借此当第二单元被根据所检测到的参数值选择性地安装在设备的机体中时使所述发生器的输出被自动调节到与所述第二单元的电极组件的不同特性相适应。
29.根据权利要求28的一套零件,其特征在于所述第一单元包括所述发生器、一个连接器和一个用于将所述发生器连接到所述连接器的电缆线,所述每个第二单元都具有一个电极组件,所述的电极组件本身包括一个与所述第一单元的连接器相匹配的连接器。
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