CN100531678C - 电外科发生器和*** - Google Patents
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Abstract
一种用于产生射频功率的电外科发生器,包括:具有三个或更多个输出连接的射频输出级、与输出级相连的一个或更多个输出功率源以及控制器,控制器可使发生器向输出连接提供第一切割RF波形或第二凝固RF波形。在组合模式下,控制器使发生器传递第一和第二RF波形,控制器包括用于向输出连接馈送波形的装置,以便在第一对输出连接之间传递第一RF波形,而在第二对输出连接之间传递第二RF波形,组合模式可以在各种设置之间调整,每种设置具有不同的第一和第二RF波形比例。控制器响应操作者激活的输入波形而使发生器提供输出波形,输出波形以预定的起始设置开始、以预定的结束设置结束,并根据预定的进展在起始和结束设置之间改变。
Description
技术领域
本发明涉及一种电外科发生器以及一种电外科***,该***包括发生器和具有两个或更多个治疗电极的电外科仪器。该***通常用于外科干预时的组织切割和/或凝固,其中,最常见的是用于“主切口”或微创手术,也用在腹腔镜外科或“开放性”的手术中。
背景技术
众所周知的是需要提供一种电外科发生器,其为切割和凝固提供不同的射频信号,并且还提供混合信号,其中,发生器在用于切割和凝固的信号之间迅速交替。我们的美国专利No.6416509以及授予Judson的美国专利No.3885569描述了这种混合信号。
发明内容
根据本发明,提供了一种用于产生射频功率的电外科发生器***,该发生器包括:
(i)射频输出级,具有三个或更多个输出连接,
(ii)一个或更多个与所述输出级相连的射频源,
(iii)控制器,能够使所述***向所述输出连接提供第一切割RF波形或者向所述输出连接提供第二凝固RF波形,而且在组合模式下传递第一和第二RF波形,所述控制器包括向输出连接馈送波形的装置,从而在第一对输出连接之间传递第一RF波形,并在第二对输出连接之间传递第二RF波形,所述***被设置为:组合模式可以在各种设置之间作调整,每种设置具有不同的第一和第二RF波形比例,而且所述控制器响应操作者激活的输入信号而使所述***提供输出波形序列,所述输出波形序列以预定的起始设置开始,以预定的结束设置结束,并根据预定的进展在起始和结束设置之间改变。
在我们的待审欧洲专利申请EP1287788中描述了一种电外科***,其中,操作者可以在切割信号和凝固信号之间进行选择。当选择切割信号时,该信号被提供到一对电外科电极,而当选择凝固信号时,该信号被提供到另一对电外科电极。我们的待审美国专利申请US2003—0163124为该***的改进,其中,它还提供了组合操作模式,但提供给不同组电外科电极的组合信号的成分是不同的。本发明作了进一步的改进,其中,输出波形序列从预定的起始设置进展到预定的结束设置。
波形序列的进展为使用者提供了若干好处。当电外科仪器用于切割组织尤其是厚组织时,在切割开始之前难以完全凝固组织。如果在切割开始之前进行的凝固时间延长,就存在组织的某些部分干化的风险。干化的组织无法接收RF能量,因而随后施加的切割波形不会生效。相反,如果凝固不完全,则存在切割期间出血的风险。因此外科医生在遭遇出血时(有必要反复操作脚踏开关等)希望在电外科发生器的凝固和切割模式之间进行反复切换。当进行组织处理时,本申请所述的优选发生器在切割过程中始终都维持有凝固成分,而且切割和凝固波形的比例不同。
优选地,第一RF切割波形为这样的波形:其中,横跨输出连接的射频输出电压至少被限制为用于组织切割或汽化的第一预定阈值;而且第二RF凝固波形为这样的波形:其中,横跨输出连接的射频输出电压被限制为用于凝固的第二阈值。
所述发生器的“组合模式”能够以不同的方式进行设置。在一种设置中,所述发生器***包括单一的射频功率源,并且在组合模式中,所述控制器能够使所述发生器***在传递第一切割RF波形和第二凝固RF波形之间不断地交替变化。这是专利号为No.6416509和3885569的美国专利中提到的更传统的“混合”信号。可选地,所述发生器***至少包括以不同频率工作的第一和第二射频功率源,第一射频功率源适于传递第一切割RF波形,而第二射频功率源适于传递第二凝固RF波形,并且在组合模式下,所述控制器能够使所述发生器***同时传递第一和第二RF波形。这是一种不同的设置,其中,两个RF源的输出同时提供给仪器。然而,当仪器处于使用中时,两种设置具有将切割和凝固RF信号提供给电外科仪器的效果。
在优选的设置中,各种设置中每一个设置都具有第一RF波形的第一预定占空比和第二RF波形的第二预定占空比。优选地,预定的起始设置具有这样的波形组合:即第二RF波形所占比例大于第一RF波形所占比例。此外,预定的结束设置具有这样的波形组合:即第一RF波形所占比例大于第二RF波形所占比例。便利地,所述起始设置为这样一种波形:其第二占空比介于所有波形的70%和100%之间,典型地在总传递输出的90%和100%之间。可选择地或附加地,所述结束设置为这样一种波形:其第一占空比介于所有波形的70%和100%之间,典型地在总传递输出的90%和100%之间。在一种典型设置中,起始设置为这样一种组合波形:其第二占空比为总传递输出的100%,而结束设置为这样一种混合波形:其第一占空比为总传递输出的90%。
在上述设置中,不仅发生器在整个切割过程中维持有凝固成分,而且凝固波形所占比例比切割过程开始时更大。因而,如果外科医生在电外科切割期间遇到出血的情况,外科医生可松开并随即重新激活脚踏开关或者其它启动机制。这将把所述进展复位至具有高比例凝固的起始设置,其中在起始设置中具有高比例的凝固。
优选地,从起始设置到结束设置的预定进展为贯穿预定时间的连贯进展。这确保一旦可行就能对组织作电外科切割。可选地,该进展可以是不连贯的进展,而是例如具有恒定设置的初始期(例如,支配性的凝固波形),之后的进展从该初始期至结束设置(例如,支配性的切割波形)。无论进展是否是连贯的,发生器从其起始设置至其结束设置所花费的时间是可变的,这取决于连接到发生器的仪器的类型、或所要治疗的组织的类型。
优选地,所述控制器适于以脉冲序列的形式提供所有的输出波形序列,为了方便,频率可以在0.5到50Hz之间,而且典型地,频率在15到25Hz之间。
本发明还包括一种电外科***,它具有用于产生射频功率的电外科发生器装置,还具有包括至少3个电极的电外科仪器,所述发生器装置包括:
(i)射频输出级,具有至少三个与所述仪器的电极电连接的输出连接,
(ii)连接到所述输出级、用于向所述输出级供电的电源,
(iii)控制器,可使所述发生器装置提供一种混合输出波形序列,所述混合输出波形序列在横跨所述输出连接的第一输出波形与第二输出波形之间不断地交替变化,其中,对于第一输出波形,横跨输出连接的射频输出电压至少被限制为用于组织切割或汽化的第一预定阈值,而对于第二输出波形,横跨输出连接的射频输出电压被限制为用于凝固的第二阈值,所述控制器包括向输出连接馈送波形的装置,以便在第一对输出连接之间传递第一输出波形,并在第二对输出连接之间传递第二输出波形,所述控制器能够使所述发生器装置以各种设置传递波形,每种设置都具有被限制为用于切割或汽化的第一阈值的第一预定波形占空比以及被限制为用于凝固的第二阈值的第二预定波形占空比,该发生器装置被设置为:所述控制器响应操作者所激活的输入信号而使所述发生器装置提供输出波形序列,所述输出波形序列以预定的起始设置开始、以预定的结束设置结束,并根据预定的进展在起始和结束设置之间改变。优选地,至少两个电极具有夹片对的形式。
本发明还延伸到一种电外科***,包括:
(i)双极电外科仪器,包括手柄、夹片构件,被设置成操作手柄可允许夹片构件的对置夹片关于彼此打开或闭合;所述对置夹片的第一夹片至少具有第一凝固电极;所述对置夹片的另一个夹片至少具有第二凝固电极;以及切割电极,通过绝缘构件与第二凝固电极隔离,以及
(ii)发生器装置,包括:一个或更多个RF输出功率源;控制器,可以控制所述发生器装置,使其能够向所述电外科仪器提供第一切割RF波形,或者向所述电外科仪器提供第二凝固RF波形,并且在组合模式下传递第一和第二RF波形,所述波形被馈送至所述电外科仪器,从而在组合模式下,在切割电极与第一和第二凝固电极中的至少一个之间传递切割RF波形,并且在第一和第二凝固电极之间传递凝固RF波形,所述组合模式可以在各种设置之间调整,每种设置具有不同的第一和第二RF波形比例,所述发生器装置被设置为:所述控制器响应操作者激活的输入信号而使所述发生器装置提供输出波形序列,所述输出波形序列以预定起始设置开始,以预定的结束设置结束,并且根据预定的进展在起始和结束设置之间改变。
本发明还在于一种电外科发生器,包括:射频源、用于连接到电外科仪器的多个输出端子、将所述射频源连接到所述输出端子的连接级、以及被配置为根据混合治疗序列而调整所述连接级的控制级,在所述混合治疗序列中,射频能量作为分别用于组织切割或汽化和组织凝固的第一和第二波形的组合被提供到所述输出端子,其中,所述控制级被配置为:当所述序列激活时,第二波形占据支配地位,而在预定的建立期结束后,第一波形占据支配地位,在建立期中,两个波形的相对比例逐步改变经过中间比例。
附图说明
下面参考附图仅通过示例对本发明作进一步描述。在附图中:
图1为根据本发明的电外科***的示意图,
图2为图1所示发生器的框图,
图3为用作图1所示***的一部分的电外科仪器的示意性透视图,
图4为用于图1所示***中的开关电路的示意图,
图5A和5B为用作图4所示开关电路的两个电子开关设备的电路图,
图6为用于图1所示***中的开关电路的备选实施方式的示意图,
图7为图2所示发生器的框图,其合并有图4所示的开关电路,
图8A—8C为描述用于调整混合开关比例的技术的示意图,图8A和8C为备选的比例调整设备的电路图,图8B为描述8A所示设备的操作的波形图,
图9为根据本发明的发生器***的备选实施方式的框图,
图10为根据本发明的另一备选***的框图,
图11A和11B为用于将切割和凝固输出自动馈送到各个不同电极对的其它备选***,
图12和13为根据本发明的其它备选***的框图,
图14A和14B为显示出能由根据本发明的发生器所产生的不同混合波形的波形图,
图15为用作根据本发明的电外科***一部分的脚踏开关的示意图,
图16和17为描述了根据本发明的发生器的调整过程的示意图,
图18为用作图1所示***一部分的备选电外科仪器的示意性截面图,
图19为图18所示仪器上的夹片部件的透视图,
图20为图18所示仪器主体的横截面图,
图21为图19所示的夹片部件的端视图,以及
图22为图19所示的夹片部件的侧视图。
具体实施方式
参考图1,发生器10具有输出插座10S,插座10S通过连接电缆14为仪器12提供射频(RF)输出。发生器的激活可以通过连接电缆14或利用脚踏开关单元16从仪器12中执行,如图所示,脚踏开关单元通过脚踏开关连接电缆18连接到发生器的背面。在所述实施方式中,脚踏开关单元16具有两个分别用于选择发生器的凝固模式和切割模式的踏板16A和16B。该发生器的前部面板具有分别用于设置凝固和切割功率电平的按钮20和22,所设置的凝固和切割功率电平在显示屏24中显示。按钮26被设置为用于在凝固和切割模式之间进行选择的备选装置。
参考图2,该发生器包括射频(RF)功率振荡器60,其具有用于连接到仪器12的一对输出线60C。该仪器12以电负载64的形式示于图2中。通过开关模式电源66向振荡器60提供功率。在优选实施例中,该射频振荡器60以约400kHz的频率工作,从300kHz上至高频范围的频率都是可行的。开关模式电源一般在25至50kHz范围内的频率上工作。与输出线60C交叉连接的是电压阈值检测器68,其第一输出68A连接到开关模式电源16,而第二输出68B连接到“on”时间控制电路70。与操作者控制和显示器(示于图1中)相连的微处理器控制器72连接到电源66的控制输入66A,用于通过电源电压变化而调整发生器的输出功率,微处理器控制器72还与电压阈值检测器68的阈值设置输入68C相连,用于设置峰值RF输出电压的界限。
在工作中,当外科医生需要电外科能量而操作设置在机头或脚踏开关(见图1)上的激活开关装置时,微处理器控制器72将功率施加到开关模式电源66。根据发生器前部面板上的控制设定(见图1),通过输入68C与电源电压无关地设置恒定的输出电压阈值。一般而言,为了干化或凝固,阈值被设定为150V至200V之间的干化阈值。当需要切割或汽化输出时,阈值被设定在250V或300V到600V范围内的值。这些电压值为峰值。它们为峰值意味着:至少为了干化,优选在将电压钳位至给定值之前使具有低振幅因数的输出RF波形给出最大功率。一般可以实现1.5或更小的振幅因数。当需要组合模式的输出时,通过输入68C而设定的电压输出在用于干化或凝固的数值与用于切割或汽化的数值之间不断地交替以形成混合波形。
当发生器首次激活时,射频振荡器60(其和“on”时间控制电路70相连)的控制输入60I处于“on”状态,从而在每一个振荡周期中,把形成振荡器60中的振荡元件的功率开关设备在最大导通周期中接通。传递至负载64的功率部分取决于开关模式电源66施加到RF振荡器60的电源电压,部分取决于负载阻抗64。干化输出的电压阈值被设置为使触发信号被发送到“on”时间控制电路70,并且当到达电压阈值时发送到开关模式电源66。“on”时间控制电路70具有实际上在瞬间减小RF振荡器开关设备的“on”时间的效果。同时,开关模式电源失效,从而提供至振荡器60的电压开始下落。我们的欧洲专利申请No.0754437中对这种方式的发生器操作做了详细描述,其所公开的内容在此引入作为参考。
图3显示了电外科仪器12的一种可能的设计。该仪器12包括仪器轴5,位于其远端的是大体上由附图标记8所示的电极部件。该电极机构8包括设置在两个更大的凝固电极3和40之间的中心切割电极2。绝缘层4将切割电极2和第一凝固电极3隔离,同时绝缘层41将切割电极2与第二凝固电极40隔离。该切割电极2稍稍突出超过两个凝固电极。
当使用者试图用该仪器来切割组织时,发生器在切割电极2与凝固电极3和40中的一个或两个之间施加切割RF波形。相反地,当使用者试图用该仪器凝固组织时,发生器在两个凝固电极3和40之间施加凝固RF波形。将通过参考图4所示的开关电路来描述混合RF波形的施加。
图4显示了大体上由附图标记45表示的开关电路,该电路包括分别连接到发生器10的两个输出线60C的输入连接46和47。开关电路45具有3个输出连接48、49和50。输出连接48与图3所示设备的切割电极2相连。输出连接49和50分别连接至图3所示设备的凝固电极3和40。电子开关装置51连接在输出连接48和49之间。开关51能够对输出线48和49之间的连接进行快速连接和断开。电容器53连接在输出连接49和50之间,该电容器一般在1和10nF之间。
当使用者激活踏板16A或16B从而以混合模式操作仪器12时,发生器向输入连接46和47提供RF切割和凝固波形的交替脉冲。开关设备51和交替的RF波形同步操作,从而当接收到含有切割波形的那部分波形时,该开关装置被打开,从而输出连接48和49之间为开路。这样,分别通过输出连接48和50在切割电极2和凝固电极40之间施加切割RF波形。相反地,当在输入连接46和47上接收到包含凝固电压的那部分波形时,关闭开关设备51,从而输出连接48和49相互处于电连通状态。这样,在混合波形的凝固部分中,通过输出接口49和50在两个凝固电极3和40之间施加该波形,电容器53在它们之间提供电势差。
开关装置51可以包括诸如图5A所示的光耦合双FET部件的AC光中继(opto-relay)。如图5B所示,另一个在控制电路和输出线之间提供隔离的开关设备是AC电桥和通过隔离驱动器控制的单个MOSFET开关的组合。
上文描述基于控制混合模式波形的发生器10及其同步接通和断开的开关设备51。然而,并不一定是这种情况,而且开关设备可以控制发生器以确定切割和凝固RF波形之间的转变。
考虑图4所示的开关电路45。当开关设备51处于打开状态时,切割波形被施加到输出连接48和50上。当开关设备51闭合时,切割波形最初被施加在由电容器53所隔离的输出连接49和50之间。这导致由发生器所传递的电流立即增大,以致发生器中的限流电路工作以减小所传递的功率,从而波形迅速转变成用于凝固的典型RF波形。发生器中的限流电路的作用是:开关设备51的闭合几乎在瞬间把正在传递的波形从切割波形转换为凝固波形。相反地,当开关设备51再次打开时,发生器不再限制电流,并且波形再一次迅速恢复至切割RF波形。以这种方式,开关设备51的打开和闭合使发生器在其切割和凝固模式之间来回切换,从而产生了提供给仪器12的电极的混合波形。
图6显示了开关电路的备选实施例,当发生器10不作为限流发生器的时候,或者在不准备使用发生器的限流特征的时候,可以采用图6中的备选实施例。图6所示的开关电路几乎和图4所示的开关电路相同,主要区别是增加了与输入连接46串联的附加电容器52。该电容器52的电容值一般为电容器53的一半,从而输出连接49和50上传递的电压被分成典型地用于凝固的电平,而不必减小发生器10的功率输出。以这种方式,当开关设备51打开时,在输出连接48和50之间传递切割RF波形,而且当开关设备闭合时在输出连接49和50之间传递凝固RF波形。
开关电路45可设置在电外科仪器12内或图7所示的发生器10的输出级内。无论开关电路45位于何处,都可以在开关设备上设有调整设备55(如图6所示),***的使用者可以操作调整设备55以便调整开关设备的定时。通过操作调整设备55,使用者能够改变作为切割波形的那部分混合RF波形与作为凝固波形的那部分混合RF波形之间的比率。无论调整设备55位于仪器12上还是发生器10上,***的使用者都可以改变波形以相对于切割成分而言增加或减少混合波形中的凝固成分,反之亦然。这赋予了电外科***在其同时用作切割和凝固设备方面很大的灵活性,使用者可操作地控制提供多少凝固波形。
按照图4中的上述装置,图6所示的备选开关电路的开关设备51可以如图5A或图5B中所示,可以从与开关设备自身相关的源或者发生器内控制其它发生器功能的控制电路中获得驱动信号。
用于实现调整设备55的各种电路对本领域技术人员而言是显而易见的。图8A显示了电路的一个例子,其中,混合模式波形由与开关设备相关的元件产生,并且具有可变的标号-空白比(mark-to-spaceratio)。在这种情况下,三角波发生器56的输出在比较器57中与使用者可调整的参考电压进行比较,以产生开关设备51(图6)的方波。图8C显示了另一产生可调整混合模式开关设备的控制信号的电路。这里,使用者可操作的电位计58与使用555ic的定时器电路59相连。
图9显示了采用两个RF源电路74和74’的备选发生器***。源电路74包括RF振荡器60及其相关的电源和控制元件。参考图2对源电路进行描述,并且为相似的元件赋予和图2所示相似的附图标记。第二发射74’包括第二RF振荡器60’,以及第二控制器72’,电源66’,电压阈值检测器68’以及准时控制电路70’。图9显示了源电路74’,其各个单元具有自身专用的形式,虽然它们中的特定部分(如电源66’和控制器72’)可以与源电路74共用。电压阈值检测器68被设置为使来自源电路74的输出连接60C提供具有切割RF波形的输出功率波形,同时电压阈值检测器68’被设置为使来自源电路74’的输出连接60C’提供具有凝固RF波形的输出功率波形。第二振荡器60’以与振荡器60不相同的频率而工作。
为两个源电路74和74’提供公共输出级73。来自源电路74的输出连接60C连接到输出级73的输入连接46和47,而来自源电路74’的输出连接60C’分别与输出级的输入连接46’和47’相连。在输出级73中,输入连接47和47’都连接到输出连接49,而输入连接46连接到输出连接48,并且输入连接46’连接到输出连接50。这种设置的结果是:来自源电路74的切割RF波形在输出连接48和49之间传递,因而传递到电外科仪器12的一对电极。同时,来自源电路74’的凝固RF波形在输出连接49和50之间传递,因而传递到仪器12的另一对电极。这样,电外科仪器12能够通过两种不同频率的波形同时切割并凝固组织。按照前述内容,其优点在于切割波形和凝固波形,无论它们是同时施加的还是处于交替变化的混合波形中,都可以传递到电外科仪器的不同电极对。因此,可以取决于这些电极是用于切割组织还是凝固组织而对这些电极的设计进行最优化。
参考图10,在另一备选的发生器和仪器的组合中,两个RF功率振荡器60-1和60-2从公共电源62中获取能量,并受到公共控制器72的控制以在各个输出线60C上产生适用于切割的RF功率波形和适用于凝固的RF功率波形。这些波形可以被馈给到开关电路63,以根据来自例如脚踏开关的输入选择来自一个振荡器60-1或其它振荡器60-2的功率信号,所选择的功率波形在输出连接80、81上传输。在混合模式中,以预定的速率重复操作开关,以产生连接80、81上的混合输出功率波形。功率发生器60-1、60-2以不同的频率工作,并且通过将输出连接80、81上的功率波形馈送至被调谐为不同频率的调谐电路82-1和82-2分别把切割和凝固波形馈送给需要的电极。调谐电路的输出通过电极线48、49和50连接到电外科仪器的各个电极上。以这种方式,把来自振荡器60-1的切割波形馈送至切割电极48和公共电极49,而把来自振荡器60-2的凝固波形馈送至凝固电极50和公共电极49。
在如图10所示的实施例中,电外科发生器和电外科仪器之间的连接一般通过输出连接80和81而提供,但是发生器和仪器之间的电路块的分配可以改变。
图11A和11B显示了其它实施例。与如9所示的实施例相似,这些实施例无需信号路由开关或开关电路。
参考图11,它提供了被调谐至不同频率的两个调谐电路82-1和82-2(如图10所示)。每个电路具有串联谐振电感器-电容器对84以及并联谐振电感器-电容器对86,后者为一方面与输出连接46和47相连、另一方面与46`和47`相连的变压器。在图10所示的实施例中,每个调谐电路具有两个输入,其一与发生器的输出连接80相连,而另一个则与发生器的输出连接81相连。在这个实施例中,发生器具有包含RF开关的输出级,所述RF开关被设置成两个起相反作用的推拉对90A、90B和91A、91B。一般而言,这些开关包括功率MOSFET。如图所示,每个开关90A、90B、91A、91B都连接到驱动器输入92、93,驱动器输入92、93接收RF驱动信号,用于在输出连接80、81上产生具有切割波形的输出的RF驱动信号具有某一个频率,而用于在输出连接80、81上产生凝固输出的RF驱动信号具有不同的RF频率,这些频率分别为第一调谐电路82-1的谐振组合体84、86的谐振频率,以及另一调谐电路82-2的相应谐振组合体的谐振频率。如上所述,发生器输出级的RF开关90A、90B、91A和91B可以根据例如脚踏开关的控制而驱动以产生切割输出或凝固输出。此外,额外地,可以生成混合输出,其中,RF频率在调谐输出电路的两个谐振频率之间不断地交替变化。
图11B的实施例是图11A所示实施例的一种修改,其中,发生器的输出级具有单一的推拉式RF开关对90A、90B,并且其中每个调谐电路的一个输入连接到开关90A和90B之间的连接点,另一个输入连接到地。
图12显示了发生器电路的另一个实施例,其中,切割和凝固输出与切换电路串联连接。输入连接131和132都连接到发射器的输出,而且输出连接133和134与电外科仪器12的凝固电极相连。输出连接135与电外科仪器12的切割电极相连。
在输入连接131和132之间具有包含第一变压器136和第二变压器137的电桥电路。第一变压器136包括主线圈138和副线圈139。第一开关元件140被设置为与主线圈138并联。第二变压器137包括主线圈141和副线圈142。第二开关元件143被设置为与主线圈141并联。开关元件140和143由控制单元144来操作。副线圈139和142与输入连接131和132串联,两个线圈139、142之间的连接点构成了电桥输出。
第二变压器137为降压变压器,其中副线圈142本身是与输出连接133和134连接的另一个中间抽头的副线圈145的主线圈。隔离电容器146设置在电桥电路和切割输出连接135之间,并且另外的隔离电容器147和148设置在电桥电路与凝固输出连接133和134之间。
电路按照下述进行工作:对于预定周期,控制单元144操作开关元件143使其闭合并使第二变压器137的主线圈141短路。在这种情况下,随着第二变压器141被有效地短路,发生器的输出在输出连接135和输出连接133、134之间传递。它具有这样的效果:为电外科仪器12的切割电极施加关于其凝固电极的RF输出电压,其可有效地作为电外科切割操作的返回电极。
在预定周期的末期,控制单元144工作以打开开关143,并随后闭合开关140以短路第一变压器136的主线圈138。在开关143打开和开关140闭合之间有一个短暂的预定延迟,以确保两个开关不会同时闭合(因为这会使发生器的输出连接短路)。随着开关140的闭合,第一变压器136被有效地短路,并且发生器的输出整个被导入第二变压器137。第二变压器是降压变压器,并在输出连接133和134之间提供较低电压信号。它具有这样的效果,即对电外科仪器12的第一和第二凝固电极施加电压,以便在它们之间产生RF凝固电压。
在预定时间之后,控制单元144打开开关140,继而闭合开关143,恢复到最初描述的切割电压被传递至电外科仪器12的切割电极的情况。通过本文所述的在两种情况之间不断地交替变化,所述电路为与其连接的电外科仪器提供快速交替变化的切割和凝固(“coag”)波形信号。以这种方式,所述仪器能够像先前描述的那样切割组织,同时凝固组织以减少出血。
图13显示了备选实施例,其中相似的元件用相似的附图标记表示。其中,图12所示的装置特别适合用作与发生器相分离的单元中的开关电路,图13所示的装置更适合用于与发生器一体化的开关电路。在图13所示的装置中,横跨主线圈138和141的开关元件140和143本身直接与发生器150串联,而不是象图12所示的那样副线圈139和142越过发生器相连。在图13中,第二变压器137被示为简单的主线圈141以及副线圈142,不带有由图12所示的两级变压器所提供的额外隔离。图13所示的电路操作基本上与参考图12进行的描述相同,其控制单元144引起开关140和143以彼此相反的方式打开和闭合。当开关140闭合时,短路主线圈138,凝固信号被提供至输出连接133和134之间。可选择地,当开关143闭合时,短路主线圈141,切割信号被提供至输出连接135与连接133和134之间。
图14A显示了第一混合输出波形序列,其包括不断交替变化的切割波形30和凝固波形31的组合。切割波形30被限制为第一电压阈值32,而凝固波形31被限制为第二(更低)电压阈值33。在50%的占空比中施加切割波形30,并且在余下的50%的占空比中施加凝固波形31。该输出波形序列产生了对组织同时进行切割和凝固的效果。
图14B显示了备选混合输出波形序列,同样在切割波形30和凝固波形31之间不断地交替变化,它们中的每一个都被限制为电压阈值32和33。然而,在图14B的输出波形序列中,在90%的占空比中施加切割波形30,而仅在10%的占空比中施加凝固波形31。该输出波形序列可以比图14A的波形更有效地切割组织,但对所治疗组织的凝固作用更小。
图14A和14B的混合波形是根据本发明的发生器***的混合输出波形序列的两个预先设定的设置,并可以通过使用图15所示的脚踏开关来选择或调整,该脚踏开关完全是常规的。脚踏开关16具有两个踏板16A和16B,踏板16A是众所周知的切割踏板(并且一般而言是黄色的),踏板16B是众所周知的凝固踏板(并且一般而言是蓝色的)。第三踏板16C被设置成模式选择踏板(该踏板一般来说相对于其它两个踏板具有不同的形状和尺寸,并且一般是黑色的)。现在参照这些踏板和图16的示意图来描述发生器***的操作。
如果外科医生使用与发生器相连的电外科仪器仅仅来凝固组织,那么凝固踏板16B的激活将导致向仪器提供100%的凝固波形。然而,当外科医生希望使用该仪器来切割组织时,切割踏板16A被激活。当切割踏板被激活时,发生器根据预定起始设置向仪器提供波形,在这种情况下是由“A”所示的100%的凝固波形。当后续能量脉冲提供给该仪器时,波形根据预定的发展而改变,直至波形为50%的切割波形和50%的凝固波形的“B”处。在时间t1之后,波形已经发展为由“C”所示的结束设置,在这个实例中为由90%的切割波形和10%的凝固波形所构成的波形。该结束设置将被施加至该仪器,直到切割踏板16B被释放。
从起始设置到结束设置的波形进展(progression)对外科医生而言具有几个优点。首先,当采用仪器切割厚组织时,经常会发生出血。这一般不能通过在切割之前对厚组织进行凝固的方法来弥补因为存在如下风险:为了确保完整的组织被凝固,某些组织将会变得“过凝固”和干化。干化的组织不能接收RF能量,因而会使随后的组织切割变得无效。这样,出血常常伴随着厚组织的切割。在本装置中,仪器维持有凝固成分,特别是在过程开始时。这样,如果外科医生在电外科切割期间遇到出血的情况,外科医生可以释放并随即再次激活切割踏板16B。这就将进程复位至图16中的“A”点,在起始设置中具有高度的凝固。
其次,切割波形比例的提升确保了组织的切割在一旦能够执行时就是有效的。在优选实现中,维持凝固波形至少为10%比例可以确保在仪器移过组织的过程中连续进行凝固。
发生器从起始设置进展到结束设置所耗费的时间取决于和发生器相连的仪器的类型而变化而,和/或取决于该仪器所治疗的组织的类型而变化。该进展时间可以是厂家设置,或者可以由使用者使用模式调整踏板16C来调整。该进展时间一般是7.5秒,虽然在适当的环境下也可以使用短至0.5秒或长至10秒的进展时间。
从起始设置到结束设置的进展不必是如图16所显示的连贯进展。例如,波形可以在进展到由90%的切割波形和10%的凝固波形组成的结束设置之前在预定时间(比如说1.5秒)内维持100%的凝固量。这就是图17所示的情况。本领域技术人员可以理解,从起始设置到结束设置的不同进展是可能的,其取决于所要进行的手术类型。
图18-22显示了备选类型的仪器,它可以与前述的电外科发生器一起使用。参考图18,双极钳设备包括一个伸长的管状轴101,其具有近端102和远端103以及在管状构件的整个长度上延伸的管腔104。具有第一手柄106和第二手柄107的剪刀形手柄构件105位于管状构件101的近端102。第二手柄107相对于第一手柄可绕枢轴销108而转动。在已知的激活机制的设计中,第二手柄107的销109附加到第二手柄107的顶部,从而手柄的移动引起U形支架111内支撑的球110发生相应的移动。
钳夹片构件112安装入管状构件101的远端103中,具体如图19所示。夹片构件112包括第一夹片构件113和第二夹片构件114,它们之间通过绝缘铆钉115而枢轴连接。夹片构件113被设置有切割电极116,其通过陶瓷绝缘体117与夹片构件113隔离。如图20所示,3个刚性导电杆118、119和120在管状构件101的管腔104中延伸,每个导电杆都覆盖有电绝缘层。杆118、119通过刚性铰链121枢轴连接至各自的夹片构件113、114,同时杆120通过导线124(在图22中最佳示出)与电极116相连。杆118、119和120的近端从管状构件开始延伸,经过球110到达接头122,该设备通过接头122可以附加到电外科发生器10。
如图19所示,切割电极116呈伸长的轨道形,其沿着夹片构件113的长度延伸。轨道116被安装在陶瓷绝缘体117上,从而它与夹片构件113绝缘。轨道116一般宽100微米,并从陶瓷绝缘体117突出约50微米。当夹片构件112处于其闭合位置时,轨道116被纳入夹片构件114中相应的纵向凹槽123中,这在图21中最佳示出。绝缘材料制成的可压缩片127设置在凹槽123中。
现在进一步描述设备的操作。当要切割组织时,将夹片构件112靠近待切组织,此时夹片构件处于其打开位置并且组织位于夹片构件的夹子125中。来自电外科发生器10的切割波形通过杆120供给切割电极116,并且钳设备沿着图22所示的箭头方向纵向移动。当该设备沿纵向移动时,搭桥在切割电极116和一个或两个夹片构件113和114之间的组织被电外科波形切断,从而在组织中形成纵向切割线。在这个过程中,夹片构件维持在其打开位置,限定了将组织限制在其中的夹子125。
通过使用处于其闭合位置的夹片构件,该设备也可以以更为常规的方式用于凝固组织。该夹片构件是闭合的,捕获夹片构件133和夹片构件114之间的组织。切割轨道116纳入凹槽123之中,并且在不使用前述的电外科切割波形的情况下,不会对其中的组织产生切割作用。来自电外科发生器10的凝固波形通过杆118和119被提供到夹片构件113和114之间。这导致固定在夹片之间的组织被凝固。
通过使用前述的混合波形,该设备也可用于同时切割和凝固组织。如前所述,夹片构件是闭合的,捕获夹片构件113和夹片构件114之间的组织。外科医生压下脚踏开关16上的切割踏板16B,并且由起始设置(100%凝固)所构成的电外科波形被提供给夹片构件113和114。该波形按前述那样进展,从而包括比例增大的切割波形,该切割波形被提供到切割轨道116与夹片113和114之间。在预定时期后,波形达到其结束设置(90%的切割波形和10%的凝固波形),上述过程持续进行,直到切割踏板16B被释放。
Claims (19)
1.一种用于产生射频功率的电外科发生器***,包括:
(i)射频输出级,具有三个或更多个输出连接,
(ii)与所述射频输出级相连的一个或更多个射频输出功率源,
(iii)控制器,能够使所述***向所述输出连接提供第一切割RF波形或向所述输出连接提供第二凝固RF波形,而且在组合模式下传递第一切割RF波形和第二凝固RF波形,所述控制器包括向输出连接馈送波形的装置,从而在第一对输出连接之间传递第一切割RF波形,并且在第二对输出连接之间传递第二凝固RF波形,
所述***被设置为:组合模式可以在各种设置之间作调整,每一种设置都具有不同的第一和第二RF波形比例,而且所述控制器响应操作者激活的输入信号而使所述***提供输出波形序列,所述输出波形序列以预定的起始设置开始、以预定的结束设置结束,并根据预定的进展在所述起始设置和结束设置之间改变。
2.根据权利要求1所述的***,其中,所述第一切割RF波形是这样一种波形:所述输出连接上的射频输出电压至少被限制为用于组织切割或汽化的第一预定阈值;而且第二凝固RF波形是这样一种波形:所述输出连接上的射频输出电压至少被限制为用于凝固的第二阈值。
3.根据权利要求1所述的***,其中,通过控制器操作以提供在第一切割RF波形和第二凝固RF波形之间不断地交替变化的混合输出波形序列而提供所述组合模式。
4.根据权利要求3所述的***,其中,所述***的配置使得其能够在多个设置之间进行调整,每一种设置都具有第一切割RF波形的第一预定占空比以及第二凝固RF波形的第二预定占空比。
5.根据权利要求4所述的***,其中,所述起始设置具有占全部传递输出的70%和100%之间的第二预定占空比。
6.根据权利要求5所述的***,其中,所述起始设置具有占全部传递输出的90%和100%之间的第二预定占空比。
7.根据权利要求4至6中任一权利要求所述的***,其中,所述结束设置具有占全部传递输出的70%和100%之间的第一预定占空比。
8.根据权利要求7所述的***,其中,所述结束设置具有占全部传递输出的90%和100%之间的第一预定占空比。
9.根据权利要求5至6中任一权利要求所述的***,其中,所述起始设置是具有占全部传递输出的100%的第二预定占空比的波形,而所述结束设置是具有占全部传递输出的90%的第一预定占空比的混合波形。
10.根据权利要求1至6中任意一项所述的***,其中,所述预定的起始设置具有这样的波形组合:第二凝固RF波形的比例大于第一切割RF波形的比例。
11.根据权利要求1至6中任意一项所述的***,其中,所述预定的结束设置具有这样的波形组合:第一切割RF波形的比例大于第二凝固RF波形的比例。
12.根据权利要求1至6中任意一项所述的***,其中,从所述起始设置到所述结束设置的所述预定进展是贯穿预定时间的连贯进展。
13.根据权利要求1所述的***,其中,所述控制器适用于提供具有脉冲序列形式的全部传递输出波形序列。
14.根据权利要求13所述的***,其中,所述脉冲的频率被设置为0.5和50Hz之间的频率。
15.根据权利要求14所述的***,其中,所述脉冲的频率被设置为15和25Hz之间的频率。
16.一种电外科***,包括用于产生射频功率的发生器装置以及至少具有3个电极的电外科仪器,所述发生器装置包括:
(i)射频输出级,具有与所述仪器的电极电连通的至少三个输出连接,
(ii)与所述输出级相连、用于向所述射频输出级供电的电源,
(iii)控制器,能够使所述发生器装置提供一种在所述输出连接上的第一输出波形与第二输出波形之间不断交替变化的混合输出波形序列,其中对于第一输出波形,输出连接上的射频输出电压至少被限制为用于组织切割或汽化的第一预定阈值,而对于第二输出波形,输出连接上的射频输出电压被限制为用于凝固的第二预定阈值,所述控制器包括用于向输出连接馈送波形、以便在第一对输出连接之间传递第一输出波形、并在第二对输出连接之间传递第二输出波形的装置,所述控制器能够使所述发生器装置以各种设置传递波形,所述各种设置中的每一种设置具有被限制为用于切割或汽化的第一阈值的第一预定波形占空比,并且具有被限制为用于凝固的第二阈值的第二预定波形占空比,
所述发生器装置被设置为:所述控制器响应操作者所激活的输入信号而使所述发生器装置提供输出波形序列,所述输出波形序列以预定的起始设置开始、以预定的结束设置结束,并根据预定的进展在所述起始和结束设置之间改变。
17.根据权利要求16所述的***,其中,所述电极中至少两个电极具有夹片对的形式。
18.一种电外科***,包括:
(i)双极电外科仪器,包括:手柄、夹片构件,被设置为使手柄的操作允许夹片构件的对置夹片关于彼此打开或闭合;所述对置夹片的第一夹片至少具有第一凝固电极;所述对置夹片的另一个夹片至少具有第二凝固电极;以及切割电极,通过绝缘构件与第二凝固电极分离,以及
(ii)发生器装置,包括:一个或更多个RF输出功率源;控制器,控制所述发生器,使其能够向所述双极电外科仪器提供第一切割RF波形或者向所述双极电外科仪器提供第二凝固RF波形,并且在组合模式下传递第一切割RF波形和第二凝固RF波形,所述波形被馈送至所述电外科仪器,从而在组合模式下,在切割电极与第一和第二凝固电极中至少一个之间传递第一切割RF波形,并且在第一和第二凝固电极之间传递第二凝固RF波形,所述组合模式可以在各种设置之间调整,每一种设置具有不同的第一切割RF波形和第二凝固RF波形比例,
所述发生器装置***被设置为:所述控制器响应操作者激活的输入波形而使所述发生器装置提供输出波形序列,所述输出波形序列以预定的起始设置开始、以预定的结束设置结束,并且根据预定的进展在所述起始和结束设置之间改变。
19.一种电外科发生器,包括射频源、用于连接到电外科仪器的多个输出端子、将所述射频源连接到所述输出端子的连接级、以及被配置为根据混合治疗序列而调整所述连接级的控制级,在所述混合治疗序列中,射频能量作为分别用于组织切割或汽化和组织凝固的第一和第二波形的组合被提供到所述输出端子,其中,所述控制级被配置为:当所述序列激活时,第二波形占据支配地位,而在预定的建立期结束后,第一波形占据支配地位,在建立期中,两个波形的相对比例逐步改变经过中间比例。
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US6875210B2 (en) * | 2002-11-19 | 2005-04-05 | Conmed Corporation | Electrosurgical generator and method for cross-checking mode functionality |
-
2004
- 2004-11-12 GB GB0425051A patent/GB0425051D0/en not_active Ceased
-
2005
- 2005-09-27 AT AT05786860T patent/ATE442093T1/de not_active IP Right Cessation
- 2005-09-27 ES ES05786860T patent/ES2333240T3/es active Active
- 2005-09-27 WO PCT/GB2005/003721 patent/WO2006051252A1/en active Application Filing
- 2005-09-27 CN CNB2005800384053A patent/CN100531678C/zh active Active
- 2005-09-27 DE DE602005016592T patent/DE602005016592D1/de active Active
- 2005-09-27 AU AU2005303650A patent/AU2005303650B2/en active Active
- 2005-09-27 EP EP05786860A patent/EP1814481B1/en active Active
Also Published As
Publication number | Publication date |
---|---|
EP1814481A1 (en) | 2007-08-08 |
EP1814481B1 (en) | 2009-09-09 |
ES2333240T3 (es) | 2010-02-18 |
DE602005016592D1 (de) | 2009-10-22 |
WO2006051252A1 (en) | 2006-05-18 |
CN101072543A (zh) | 2007-11-14 |
GB0425051D0 (en) | 2004-12-15 |
AU2005303650A1 (en) | 2006-05-18 |
AU2005303650B2 (en) | 2011-05-12 |
ATE442093T1 (de) | 2009-09-15 |
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