CN100484493C - 控制组织缝合的系统和方法 - Google Patents
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Abstract
本发明涉及一种在第一阶段中向组织缝合器械(300)的电极(310)输送RF电压,以实现生物组织缝合的系统和方法;其中包括:监控组织的阻抗,并确定在第一阶段的最小组织阻抗值;确定相对阻抗;检测所述相对组织阻抗达到预先确定的相对组织阻抗值的时间,并开始第二阶段;将第二阶段的持续时间作为第一阶段持续时间的函数,进行计算;在第二阶段中向组织缝合器械(300)的电极(310)输送RF电压。
Description
相关申请的相互参照
本申请涉及1999年2月12日提出的美国专利申请号为09/022,869号,发明名称为“利用输送流经软组织的高频电流实现生物软组织缝合的方法”的专利申请。本发明结合了该专利的相关内容。
发明背景
本发明涉及软组织连接或缝合,尤其是涉及一种控制组织缝合的系统和方法。
RF电外科器械广泛用于切割、软组织手术、止血以及各种烧灼过程等一系列医疗过程中。目前常用的电外科双极设备通常使用两个极性相反的电极,每个电极分别安装在诸如抓紧器等设备相对的叉钳上。在实际使用时,将机体组织夹紧在上述电极之间,然后通过变换流经两个电极之间的RF电流对该组织进行加热。当该机体组织的温度达到约50-55℃时,组织中的清蛋白就会发生变性。清蛋白的变性经常导致清蛋白中的红细胞发生“解链”,进而发生解链红细胞的纠缠,而这种纠察又常常导致组织产生协同凝集反应。一旦某种组织按照上述步骤进行了处理,就可以在不流血的情况下对该组织融合区域进行切割操作。上述过程通常被称为双极电凝集作用。
组织缝合一般包括以下步骤:将欲缝合切口的边缘放置在一起;利用双极缝合器械将组织压紧,并通过流经上述组织的RF电流对该组织进行加热。组织缝合过程与以止血为目的的组织协同凝集过程的一个主要区别在于,组织缝合需要具备在清蛋白发生凝集反应开始之前,能够使在需要缝合的组织之间形成公共的清蛋白空间的条件。如果上述条件不具备,就会发生凝集反应,而不会形成牢固的连接。
在组织缝合过程中可能发生的问题包括以下几点:对邻近组织结构的损害;缝合组织过热,以及不完全凝集。组织过热会延缓伤口痊愈的时间、产生额外的伤疤、组织炭化/破坏,甚至会使该组织粘连到电外科器械上。一旦组织粘连到电外科器械上,当移动该器械时,就会将该组织从缝合区域拉出来,这样反而对止血产生了不利影响,进一步产生了伤害。当输送给组织上的能量不足时,就会发生不完全凝集。不完全凝集的后果是组织缝合不牢固,止血不完全。
对缝合过程进行精确控制,避免产生额外损伤、过热或者不完全凝集等现象是比较困难的,特别是当对不同结构、不同厚度、阻抗各异的组织进行缝合时,更是如此。如果缝合的目的是恢复被处理组织器官的生理机能,建立一个可行的控制机制就非常重要了。在止血过程后,经过加热处理的血管或管状组织一般都无法恢复生理机能。
以前,对组织缝合进行自动控制的尝试,其成功的可能性极为有限。避免组织过热的尝试包括利用内置温度测量设备对组织的温度进行测量。该内置温度测量设备可以用于测量组织温度、提供反馈信号,进而防止组织过热。但是,配备内置温度测量探针的电外科器械通常会比较笨重,同时,所提供的信息只是关于位于电极间、有可能形成连接的组织内层状态的有限或错误信息。
一些在先专利提出了几种利用测量的组织阻抗以及最小组织阻抗,以确定凝集完全、需中断对组织进行加热操作的时间的方法。另外,还有一些文献提出了利用组织阻抗与电流频率之间的关系检测凝集点的方法。
但是,上述在先文献中的方法都无法提供有效的、用于外科手术过程的组织缝合解决方案,特别是缺乏在缝合过程中根据不同的组织类型、厚度灵活进行调整的能力。
因此,需要提供一种既适用于组织缝合,同时又适合于止血的系统和方法,使之能够在提供牢固的组织连接的同时,在不产生过热现象的情况下,适应于不同种类、结构、厚度以及阻抗的组织。该系统和方法通过减少在缝合过程中设备调整过程,将显著地缩短进行与组织缝合相关的外科手术所需的时间。
附图说明
结合附图,可以更好地理解上述简要说明以及下述有关本发明优选实施例的详细描述。为了便于对本发明进行说明,在附图中所示的实施例是在目前优选的实施例。因此,应当可以理解的是,本发明并不仅限于图中所示的严格意义上的方法及手段。其中:
图1是对本发明的一个实施例进行说明的结构框图。
图2是本发明的一个实施例中,在第一阶段输送的电压作为时间的函数,随时间变化的曲线;
图3是本发明的另一个实施例中,作为时间的函数,在第一与第二阶段中电压、组织阻抗以及相对组织阻抗随时间变化的曲线。
图4是本发明的另一个实施例中,作为时间的函数,在第一与第二阶段中电压以及组织阻抗随时间变化的曲线。
图5是本发明的另外一个实施例中,作为时间的函数,在第一与第二阶段中电压、组织阻抗以及相对组织阻抗随时间变化的曲线。
图6是本发明的另外一个实施例中,作为时间的函数,在第一与第二阶段中电压、组织阻抗以及相对组织阻抗随时间变化的曲线。
具体实施方式
本发明可以应用到各种涉及组织融合或连接的医疗过程中,以便在对组织进行牢固缝合的同时,减小对周围组织所产生的、能够延缓组织愈合的热损害。本发明还提供了在无需对组织缝合及凝集过程中所用的设备进行调节的情况下,对不同结构、厚度和/或阻抗的组织所进行的缝合及凝集过程进行自动调节和控制的系统及方法。
图1说明的是本发明中装置10的实施例,其中,所述装置中配备有与外科设备300的电极310相匹配的电源100。该电源应可以优选地向电极310输送RF电压,同时该电源100优选地包括一个或多个用于探测电极310之间的RF电压及电流的传感器。如图1所示,上述传感器优选地包括一个电流传感器130及一个电压传感器150。而装置10进一步包括一个控制设备200。该控制设备200优选地包括一个微处理器210,以对电源100向外科医疗设备300的电极310输送RF电压的过程进行控制。虽然所述控制设备200配备有微处理器,但该控制设备200仍可以包括其他种类的可编程设备,以作为微控制器、数字信号处理器或一系列离散逻辑设备。所述装置10还可以包括一个与控制设备200相匹配的启动设备(图中未显示),以便启动控制设备200以及电源100。所述装置10还可以进一步包括一个作为用户界面的控制面板或显示设备(图中未显示)。
所述控制设备200可以优选地用于如下过程:在第一阶段中,对电源100进行控制,以向电极310输送RF电压;监控处于电极310之间机体组织的组织阻抗;确定最小组织阻抗值;通过所述机体组织阻抗值与最小组织阻抗值的比值,确定相对组织阻抗;检测在第一阶段中该相对组织阻抗达到某一预定相对组织阻抗值的时间(所述预定相对组织阻抗值是作为第一阶段中RF电压变化的函数预先设定或计算得到的);以及对电源进行控制,以在第二阶段输送RF电压。
该控制设备200优选地在第一阶段对电源100进行控制,以输送RF电压,并使该RF电压按照升幅逐渐降低的速度递增(例如,随着时间推移逐渐减小的RF电压升高速率)。在一个优选实施例中,所述RF电压按照如下方程式递增:
U=us×tk
其中,U是电压,us是一个常数,t是时间,k也是一个常数,且k<1。
图2所示为在第一阶段输送的RF电压(U)逐渐升高的变化曲线;按照如上所述方式改变RF电压可以确保在组织缝合过程中当遇到不同厚度,以及/或不同物理特性的组织时,能够自动进行调整。
所述控制设备200还可以对电源100进行控制,以对在第一阶段中输送的、递增的RF电压的进行逼近。如图2所示,以虚线绘出的近似值曲线中包含了一系列线段。
所述控制设备200优选地按照RF电压值除以电流值计算出以时间为变量的组织阻抗函数Z,确定并储存最小组织阻抗值Zmin,然后按照用组织阻抗Z除以最小组织阻抗值Zmin计算出以时间为变量的相对组织阻抗函数z。在第一阶段终止点(如图3中的A值),该控制设备200优选地利用某一预定相对组织阻抗值,或计算相对组织阻抗值。在此,第一阶段终止点的相对组织阻抗值是指“预定的”相对组织阻抗值,当计算该相对组织阻抗值时,将优选地作为在第一阶段RF电压值的函数进行计算(例如,RF电压越高,计算得到的预定相对组织阻抗值就越低)。所述预定相对组织阻抗值的范围优选地处于1~1.5之间。当所述控制设备200对电源100进行控制,以提供在第一阶段中RF电压的近似值时,应优选地为每一个线段计算或设置预定相对组织阻抗值。
当所述相对组织阻抗值达到该预定相对组织阻抗值时,所述控制设备200还优选地将第二阶段输送的RF电压值作为第一阶段输送的RF电压值的函数进行计算。在第二阶段所输送的RF电压振幅优选地约为第一阶段结束时输送的RF电压值的50~100%(也就是说,当所述相对组织阻抗值达到该预定相对组织阻抗值时)。
在一个优选实施例中,如图3所示,所述控制设备200优选地对电源100进行控制,以充分地稳定在第二阶段输送的RF电压。第二阶段的持续时间作为第一阶段持续时间的函数,优选地由该控制设备200进行计算。
所述控制设备200还优选地对电源100进行控制,以利用脉冲对第一、第二阶段输送的RF电压进行调制。所述脉冲优选地采用矩形脉冲,其频率约为100Hz~60Hz之间,其负载周期约为10~90%。为了防止细胞膜在脉冲之间的间歇时间中恢复原状,应优选地选用高频脉冲。所述脉冲的频率在第一、第二阶段也可以发生变化。
在另外一个优选实施例中,如图4所示,所述控制设备200对电源100进行控制,以便通过如上所述的方法、利用频率处于100Hz~60Hz之间的脉冲对第一、第二阶段输送的RF电压进行调制,并利用频率小于100Hz的低频脉冲进一步对第二阶段输送的RF电压进行调制。所述低频脉冲优选地采用矩形脉冲。更为优选地,所述控制设备200对电源100进行控制,以充分地稳定在第二阶段所输送RF电压的振幅。第二阶段的持续时间作为第一阶段持续时间的函数优选地由该控制设备200进行计算。
第二阶段输送的RF电压的振幅,如图4中的B点所示,作为第一阶段结束时输送的RF电压值(如图4中C点所示)的函数优选地进行计算。
对第二阶段输送的RF电压进行进一步调制的低频脉冲,其频率优选地被定义为第一阶段持续时间的函数。所述低频脉冲的频率更为优选的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。
在另外一个优选实施例中,如图5所示,所述控制设备200对电源进行控制,以按照所述相对组织阻抗函数z的方式,对第二阶段输送的RF电压进行调整。优选地,所述控制设备200对电源100进行控制,以便在第二阶段输送RF电压,并充分地将所述相对组织阻抗z稳定在第一阶段结束时达到的某个相对组织阻抗水平上(如图5中的D所示)。更明确地,所述控制设备200优选地对电源进行控制,以按照所述相对组织阻抗函数z的方式,对第二阶段输送的RF电压进行调整,其中,当所述相对组织阻抗函数值z大于所述预定相对组织阻抗值时,降低RF电压,而当所述相对组织阻抗函数值z小于所述预定相对组织阻抗值时,提高RF电压。在上述某一种情况中,该控制设备200可以优选地对电源100进行控制,以便在第二阶段中输送RF电压,并根据某预先设置的程序对相对组织阻抗进行调整。该控制设备200仍然将第二阶段的持续时间作为第一阶段持续时间的函数优选地进行计算。
在另外一个如图6所示的实施例中,所述控制设备200对电源100进行控制,以利用频率约为100Hz~60Hz的脉冲对第一、第二阶段输送的RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制。
所述控制设备200对电源100进行控制,以便在第二阶段输送RF电压,并充分地将所述相对组织阻抗z稳定在第一阶段结束时达到的相对组织阻抗水平上(如图6中的D所示)。在上述某一种情况中,该控制设备200可以优选地对电源100进行控制,以便在第二阶段中输送RF电压,并根据某预先设置的程序对相对组织阻抗进行调整。该控制设备200仍优选地将第二阶段的持续时间作为第一阶段持续时间的函数进行计算。
在如上所述的每个实施例中,该控制设备200都可以优选地进行设置,以便将调制脉冲频率调节到100Hz~60Hz范围之内,以提供最小组织阻抗以便将调制脉冲频率调节到100Hz~60Hz范围之内,进而提供最小组织阻抗。优选地,可以采用极值系统中常用的调制方法进行调制。该控制设备200还优选地在组织缝合过程中对调制脉冲的负载周期进行调整,以便降低或最小化在对组织进行破坏和加热过程中的能耗。优选地,可以采用极值自调节系统中常用的调制方法进行调制。
所述控制设备200还可以优选地对电源100进行控制,以便在缝合操作的间隙,向电极输送经过调制的RF电压脉冲串。所述脉冲串的脉冲宽度优选地处于2~15毫秒之间。所述脉冲串的频率优选地采用3~15Hz。当电极之间的机体组织的平均组织阻抗低于某预先设置的值时,就会优选地激活组织缝合过程。
所述控制设备200还可以优选地,例如,利用数学模型并根据已知的电流和RF电压,在缝合过程中计算电极的温度、电极之间的组织的温度,以及组织凝集的程度等。该计算所得的值优选地用于调整第一阶段RF电压递增速率以及组织缝合的持续时间。所述第一阶段RF电压递增速率以及组织缝合持续时间的调整过程优选地通过控制系统文献中的方法完成。优选地,已知的组织凝集模型将作为一个模型加以应用。所述调整的幅度优选地为电源递增速率以及缝合持续时间的+/—15%左右。
当在第二阶段对RF电压进行调制时,所述低频脉冲的频率优选地定义为第一阶段持续时间的函数。低频脉冲的频率更为优选的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。
优选地,所述控制设备200进一步包括一个用以根据预先设定的程序稳定或调整相对组织阻抗z(未显示)的调节系统。具体来说,所述调节系统通过按预先确定的数量改变RF电压的方式,稳定或调整相对组织阻抗z,对RF电压的调整是根据相对组织阻抗z的变化方向进行的。
所述控制设备200优选地进一步包括如下装置:监控组织缝合的装置、终止组织缝合的装置,以及如果在第一阶段输送的RF电压达到了某个预先设定的RF电压水平,以及/或者所述相对组织阻抗未能达到预先设定的相对组织阻抗值时,向用户发出信号的装置。
所述控制设备200优选地进一步包括如下装置:监控组织缝合的装置、终止组织缝合的装置,以及当所述组织阻抗达到该组织缝合器械电极之间发生短路时的阻抗时,向用户发出信号的装置。
所述控制设备200优选地进一步包括如下装置:监控组织缝合的装置、终止组织缝合的装置,以及在第一阶段结束后,当完成组织缝合操作时向用户发出信号的装置。所述信号是优选地在一段滞后的时间后提供的。其中,所述滞后的时间是使缝合的组织冷却所必需的。
当所述组织阻抗或者缝合操作的持续时间超过了阀值参数,该控制设备200也会优选地关闭RF电压,并向用户发送一个相应的信号。
所述控制设备200优选地进一步包括一个用于滤除组织阻抗值的滤波器。所述控制设备200也可设计用于将第一阶段的持续时间作为相对组织阻抗的函数进行控制。
在本发明所述生物组织缝合方法的一个优选实施例中,所述方法包括以下步骤:在第一阶段向组织缝合器械的电极输送RF电压;监控组织阻抗,并确定第一阶段中的最小组织阻抗值;确定相对组织阻抗;检测该相对组织阻抗达到某一预定相对组织阻抗值的时间;当所述相对组织阻抗达到某一预定相对组织阻抗值时,开始第二阶段;将第二阶段的持续时间作为第一阶段持续时间的函数进行计算;在第二阶段向组织缝合器械的电极输送RF电压。
所述相对组织阻抗优选地按照组织阻抗与最小组织阻抗值的比值进行计算。在第一阶段输送的RF电压优选地按照升幅逐渐降低的速度递增,优选地按照如下方程式递增:
U=us×tk
其中,U是电压,us是一个常数,t是时间,k也是一个常数,且k<1。
监控组织阻抗优选地包括如下步骤:测量组织缝合器械的电极之间的RF电压和电流;利用所述电压除以电流计算组织阻抗。
所述预定相对组织阻抗值优选地采用一个预先确定或设置的值,或作为第一阶段中输送的RF电压的函数计算得到的。所述预定相对组织阻抗值的范围优选地处于1~1.5之间。
第二阶段输送的RF电压优选地作为第一阶段结束时输送的RF电压值的函数进行计算(也就是说,当所述相对组织阻抗值达到该预定相对组织阻抗值时)。在第二阶段所输送的RF电压优选地约为第一阶段结束时所输送RF电压值的50~100%。
在本发明所述方法的一个优选实施例中,在第二阶段输送所述RF电压的过程包括充分地稳定所输送的RF电压。通过绘制在第一、第二阶段输送的RF电压、组织阻抗函数Z,以及相对组织阻抗z的曲线,图3对所述方法进行了说明。如图3所示,在第一阶段输送的RF电压逐渐递增,直至所述相对组织阻抗z达到某一预定的相对组织阻抗值,如图3中A点所示。如上文所讨论的一样,所述预定相对组织阻抗值可以是作为第一阶段所输送RF电压的函数,预先设置或确定的。在第二阶段,当所述相对组织阻抗达到该预定相对组织阻抗值时,系统就会输送充分稳定的RF电压。在第一、第二阶段输送的该RF电压优选地采用脉冲进行调制。所述脉冲优选地采用矩形脉冲,其频率约为100Hz~60Hz之间,其负载周期约为10~90%。所述脉冲的频率在第一、第二阶段也可以发生变化。
在本发明所述方法的另外一个实施例中,利用频率在100Hz~60Hz之间的脉冲对第一、第二阶段输送的所述RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制。在图4中对该方法进行了说明,图中绘制了在第二阶段输送的、经过低频脉冲调制后的RF电压曲线。优选地,第二阶段输送的RF电压的振幅在如图4中的B点所示的水平上是充分稳定的。所述RF电压振幅优选地作为第一阶段结束时输送的RF电压值的函数进行计算(如图4中的C点所示)。
所述低频脉冲优选地采用充分稳定的矩形脉冲。对第二阶段输送的RF电压进行调制的低频脉冲,其频率优选地定义为第一阶段持续时间的函数。所述低频脉冲的频率更为优选的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。
在本发明所述方法的另外一个不同的实施例中,所述第二阶段输送的RF电压是以所述相对组织阻抗的函数的方式进行变化的。图5对所述方法进行了说明。图中绘出了第二阶段输送的RF电压以及相对组织阻抗的曲线。
优选地,第二阶段所输送的RF电压是作为相对组织阻抗的函数的方式进行变化,其中,当所述相对组织阻抗值大于所述预定相对组织阻抗值时,降低RF电压,而当所述相对组织阻抗值z小于所述预定相对组织阻抗值时,提高RF电压。更为优选地,所述相对组织阻抗在第一阶段结束时达到的相对组织阻抗值水平上是充分稳定的。在上述某一种情况中,可以对第二阶段输送的RF电压进行调整,以便根据某预先设置的程序改变相对组织阻抗。
在本发明所述方法的另外一个不同的实施例中,如图6所示,利用频率在100Hz~60Hz之间的脉冲对第一、第二阶段输送的所述RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制,同时,所述相对组织阻抗在第一阶段结束时达到的相对组织阻抗值水平上是充分稳定的。在上述某一种情况中,可以对第二阶段输送的RF电压进行调整,以便根据某预先设置的程序改变相对组织阻抗。
所述低频脉冲优选地采用充分稳定的矩形脉冲。所述低频脉冲的频率优选地定义为第一阶段持续时间的函数。所述低频脉冲的频率更为优选的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。稳定所述相对组织阻抗的操作是由一个调节系统通过按照某个预定量或一个步骤改变RF电压的方法完成的,RF电压变化的符号与相对组织阻抗变化的符号是相反的。
以上各实施例中所述的方法优选地进一步包括如下步骤:监控组织缝合、终止组织缝合,以及如果在第一阶段输送的RF电压达到了某个预先设定的RF电压水平,以及/或者所述相对组织阻抗未能达到预先设定的相对组织阻抗值时,向用户发出一个信号。
优选地,以上各实施例中所述的方法进一步包括如下步骤:监控组织缝合、终止组织缝合,以及当所述组织阻抗达到该组织缝合器械电极之间发生短路时的阻抗时,向用户发出信号。
优选地,以上各实施例中所述的方法进一步包括如下步骤:监控组织缝合,以及在第二阶段结束后,在完成组织缝合操作时向用户发出信号。所述信号是优选地在一段滞后的时间后提供的。其中,所述滞后的时间是使缝合的组织冷却所必需的。
优选地,以上各实施例中所述的方法进一步包括如下步骤:监控组织缝合、终止组织缝合,以及当所述组织阻抗或者缝合操作的持续时间超过了阀值参数时,向用户发送一个信号。
在本发明的另外一个实施例中,对生物组织缝合进行控制的方法包括如下步骤:在第一阶段向组织缝合器械的电极输出递增的RF电压,其中,RF电压值优选地以升幅逐渐降低的速度递增;测量流经所述组织的RF电压、电流,以及第一阶段的持续时间;利用所述RF电压值除以所述电流值,计算组织阻抗值;确定最小组织阻抗值;储存该最小组织阻抗值;用所述组织阻抗值除以该最小组织阻抗值计算相对组织阻抗值;当所述相对组织阻抗值达到某个按照该相对组织阻抗值的函数计算的终点相对组织阻抗值时,终止第一阶段;储存第一阶段持续时间以及在第一阶段结束时的RF电压值(也就是说,当所述相对组织阻抗值达到该终点相对组织阻抗值时);以第二阶段的RF电压水平作为第一阶段结束时的RF电压值的函数进行计算;将第二阶段的持续时间作为第一阶段持续时间的函数,进行计算;按照上述计算得到的RF电压水平,在第二阶段输送RF电压。
在本发明的另外一个实施例中,对生物组织缝合进行控制的方法包括如下步骤:在第一阶段向组织缝合器械的电极输出递增的RF电压,其中,RF电压值优选地以升幅逐渐降低的速度递增;测量流经所述组织的RF电压、电流,以及第一阶段的持续时间;利用所述RF电压值除以所述电流值,计算组织阻抗值;确定最小组织阻抗值;储存该最小组织阻抗值;用所述组织阻抗值除以该最小组织阻抗值计算相对组织阻抗值;当所述相对组织阻抗值达到某个按照该相对组织阻抗值的函数计算的终点相对组织阻抗值时,终止第一阶段;储存第一阶段持续时间以及在第一阶段结束时的RF电压值;以第二阶段的RF电压水平作为第一阶段结束时的RF电压值的函数进行计算;将第二阶段的持续时间作为第一阶段持续时间的函数,进行计算;将调制频率作为第一阶段持续时间的函数,进行计算;按照上述计算得到的RF电压水平输送RF电压,并利用具有上述计算的调制频率的脉冲对RF电压进行调制。
在本发明的另外一个实施例中,对生物组织缝合进行控制的方法包括如下步骤:在第一阶段向组织缝合器械的电极输出递增的RF电压,其中,RF电压值优选地以升幅逐渐降低的速度递增;测量流经所述组织的RF电压、电流,以及第一阶段的持续时间;利用所述RF电压值除以所述电流值,计算组织阻抗值;确定最小组织阻抗值;储存该最小组织阻抗值;用所述组织阻抗值除以该最小组织阻抗值计算相对组织阻抗值;当所述相对组织阻抗值达到某个按照该相对组织阻抗值的函数计算的终点相对组织阻抗值时,终止第一阶段;储存第一阶段持续时间以及在第一阶段结束时的RF电压值;将第二阶段的持续时间作为第一阶段持续时间的函数,进行计算;在第二阶段输送RF电压,其中,RF电压按照第二阶段中的相对组织阻抗的函数进行变化。
在本发明的另外一个实施例中,对生物组织缝合进行控制的方法包括如下步骤:在第一阶段向组织缝合器械的电极输出递增的RF电压,其中,RF电压值优选地以升幅逐渐降低的速度递增;测量流经所述组织的RF电压、电流;利用所述RF电压值除以所述电流值,计算组织阻抗值;确定最小组织阻抗值;储存该最小组织阻抗值;用所述组织阻抗值除以该最小组织阻抗值计算相对组织阻抗值;当所述相对组织阻抗值达到某个按照该相对组织阻抗值的函数计算的终点相对组织阻抗值时,终止第一阶段;储存第一阶段持续时间以及RF电压值;以第二阶段的初始RF电压水平作为第一阶段结束时的RF电压值的函数进行计算;将第二阶段的持续时间作为第一阶段持续时间的函数,进行计算;将调制频率作为第一阶段持续时间的函数,进行计算;按照如上方法计算的第二阶段持续时间输送RF电压,为在按上述方法计算的第二阶段持续时间输送RF电压,并将RF电压的振幅初始化设置为按上述方法计算的初始RF电压水平,并利用具有按上述方法计算的调制频率的脉冲对RF电压进行调制,同时,RF电压的振幅按照相对组织阻抗的函数进行变化。
优选地,所述方法进一步包括将第二阶段中的相对组织阻抗稳定在终点相对组织阻抗值。所述稳定相对组织阻抗操作优选地由一个调节系统完成,其中,所述调节系统通过按照预定的数量改变RF电压脉冲的方式稳定相对组织阻抗,所述RF电压是根据相对组织阻抗变化的方向而变化的。
优选地,所述调节系统从计算过的初始水平,通过按照预定的数量改变RF电压脉冲的方式稳定相对组织阻抗。
优选地,所述方法进一步包括根据预先设定的方法改变所述相对组织阻抗,该变化优选地由所述调节系统完成,并对RF电压脉冲的振幅有影响。
本发明可以通过任何硬件以及软件的组合来实现。如果是通过计算机化的装置实现的,则本发明就可以利用实现如上所述的步骤以及功能的方法加以实现。本发明还可以包括在诸如配备了有效计算机媒体的产品(例如,一个或多个计算机程序产品)中。在此,该媒体已经被具体化了,比如具体化为计算机可读取的、为本发明提供相应机制、并为实现该机制提供方便的程序代码,所述产品可以作为计算机系统的一部分,也可以独立销售。
熟悉本领域的技术人员将能意识到,可以在不悖离本发明所包含的广义发明概念的情况下,对本发明如上所述的实施例进行相应的修改,因此,本发明的保护范围不仅仅局限于上述已经公开的具体实施例,而是将按照如下权利要求书所述的、涵盖本发明精神和范围中的各种变化形式。
Claims (67)
1、一种生物组织缝合的装置,其特征在于,包括:
(a)一种配备有用于啮合欲缝合组织的电极的外科医用设备;
(b)一种与所述电极匹配并用于输送RF电压的电源,其中,所述电源包括一个或多个用于探测所述电极之间的RF电压及电流的传感器,利用所述电压除以电流计算组织阻抗;
(c)一种与所述电源匹配的控制设备;
其中,所述控制设备具有如下功能:对电源进行控制,以便在第一阶段向所述电极输送RF电压;监控组织的阻抗;确定最小组织阻抗值;利用测量的组织阻抗值与该最小组织阻抗值的比值,确定相对组织阻抗;检测所述相对组织阻抗达到某一预定相对组织阻抗值的时间;以及,对电源进行控制,以在第二阶段输送RF电压,第二阶段的持续时间是作为第一阶段的持续时间的函数由控制设备进行计算。
2、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以便在第一阶段向所述电极输送RF电压,并使该RF电压按照如下方程式递增:
U=us×tk
其中,U是电压,us是一个常数,t是时间,k也是一个常数,且k<1。
3、如权利要求1所述的装置,其特征在于,所述控制设备利用所述RF电压除以所述电流,将组织阻抗作为时间的函数进行计算。
4、如权利要求1所述的装置,其特征在于,所述预定相对组织阻抗值是作为在第一阶段所述RF电压变化的函数进行计算的。
5、如权利要求1所述的装置,其特征在于,所述预定相对组织阻抗值的范围处于1~1.5之间。
6、如权利要求1所述的装置,其特征在于,当所述相对组织阻抗值达到所述预定相对组织阻抗值时,控制设备将第二阶段输送的RF电压值作为第一阶段输送的RF电压值的函数进行计算。
7、如权利要求1所述的装置,其特征在于,当所述相对组织阻抗值达到该预定相对组织阻抗值时,在第二阶段输送的RF电压的值约为第一阶所输送RF电压值的50~100%。
8、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以充分地稳定在第二阶段输送的RF电压。
9、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以便利用脉冲对第一、第二阶段输送的RF电压进行调制。
10、如权利要求9所述的装置,其特征在于,所述脉冲采用频率约为100Hz~60kHz之间,负载周期约为10~90%的脉冲。
11、如权利要求9所述的装置,其特征在于,所述脉冲的频率在第一、第二阶段也可以发生变化。
12、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以便利用频率在100Hz~60kHz之间的脉冲对第一、第二阶段输送的所述RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制。
13、如权利要求12所述的装置,其特征在于,所述控制设备对电源进行控制,以充分稳定在第二阶段输送的该RF电压,其中,所述RF电压的振幅是当所述相对组织阻抗值达到所述预定相对组织阻抗值时,作为第一阶段输送的RF电压值的函数进行计算的。
14、如权利要求12所述的装置,其特征在于,所述低频脉冲的频率被定义为第一阶段持续时间的函数。
15、如权利要求12所述的装置,其特征在于,所述低频脉冲的频率的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。
16、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以按照所述相对组织阻抗函数的方式,对第二阶段输送的RF电压进行调整。
17、如权利要求16所述的装置,其特征在于,所述控制设备对电源进行控制,以便在第二阶段改变RF电压,并充分地将所述相对组织阻抗稳定在第一阶段结束时达到的某个相对组织阻抗水平。
18、如权利要求16所述的装置,其特征在于,所述控制设备依据当所述相对组织阻抗值大于所述预定相对组织阻抗值时,降低RF电压,而当所述相对组织阻抗值小于所述预定相对组织阻抗值时,提高RF电压对电源进行控制,以按照所述相对组织阻抗函数的方式,对第二阶段输送的RF电压进行调整。
19、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以在第二阶段输送RF电压,并对相对组织阻抗值进行调节。
20、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以便利用频率处于100Hz~60kHz之间的脉冲对第一、第二阶段输送的RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制,同时,所述控制设备对电源进行控制,以便在第二阶段提供能够充分地将所述相对组织阻抗稳定在第一阶段结束时达到的某个相对组织阻抗水平上的RF电压。
21、如权利要求20所述的装置,其特征在于,所述低频脉冲的频率被定义为第一阶段持续时间的函数。
22、如权利要求20所述的装置,其特征在于,所述低频脉冲的频率的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。
23、如权利要求20所述的装置,其特征在于,所述控制设备进一步包括用于稳定所述相对组织阻抗的调节系统。
24、如权利要求23所述的装置,其特征在于,所述调节系统通过按照预定的数量改变RF电压的方式稳定相对组织阻抗,所述RF电压变化符号与相对组织阻抗变化的符号是相反的。
25、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以便利用频率处于100Hz~60kHz之间的脉冲对第一、第二阶段输送的RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制,同时,所述控制设备对电源进行控制,以便在第二阶段输送RF电压,并对相对组织阻抗进行调整。
26、如权利要求1所述的装置,其特征在于,进一步包括一个通过按预先确定的数量改变RF电压的方式调整相对组织阻抗的调节系统,所述RF电压变化符号与相对组织阻抗的变化符号是相反的。
27、如权利要求1所述的装置,其特征在于,所述控制设备进一步包括如下装置:监控组织缝合的装置、终止组织缝合的装置,以及如果在第一阶段输送的RF电压达到了某个预先设定的RF电压水平,以及/或者所述相对组织阻抗未能达到预先设定的相对组织阻抗值时,向用户发出信号的装置。
28、如权利要求1所述的装置,其特征在于,所述控制设备进一步包括如下装置:监控组织缝合的装置、终止组织缝合的装置,以及当所述组织阻抗达到该组织缝合器械电极之间发生短路时的阻抗时,向用户发出信号的装置。
29、如权利要求1所述的装置,其特征在于,所述控制设备进一步包括如下装置:监控组织缝合的装置,以及当第二阶段结束后完成组织缝合操作,同时所述被缝合组织充分冷却之后,向用户发出信号的装置。
30、如权利要求1所述的装置,其特征在于,所述控制设备进一步包括监控组织缝合的装置,以及当所述组织阻抗超过了预先设置的值,以及/或者如果第一阶段的持续时间超过了预先设置的值时,所述控制设备将RF电压在某稳定的水平保持预先设定的时间,终止组织缝合操作,并且,当所述相对组织阻抗未能达到预先设定的相对组织阻抗时,所述控制设备向用户发送信号。
31、如权利要求1所述的装置,其特征在于,所述控制设备对电源进行控制,以利用一系列线段,对在第一阶段中输送的、递增的RF电压的进行逼近。
32、如权利要求1所述的装置,其特征在于,所述控制设备进一步包括一个用于滤除组织阻抗值的滤波器。
33、如权利要求1所述的装置,其特征在于,所述控制设备将第一阶段的持续时间作为相对组织阻抗的函数进行控制。
34、如权利要求9所述的装置,其特征在于,所述控制设备对调制脉冲在100Hz~60kHz之间进行调节,以提供最小组织阻抗。
35、如权利要求9所述的装置,其特征在于,所述控制设备在组织缝合过程中对调制脉冲的负载周期进行调整,以便使在对组织进行破坏和加热过程中的能耗最小化。
36、如权利要求1所述的装置,其特征在于,所述控制设备进一步对电源进行控制,以便在缝合操作的间隙,向电极输送经过调制的RF电压脉冲串,所述脉冲串的脉冲宽度处于2~15毫秒之间,所述脉冲串的频率采用3~15Hz,当电极之间的机体组织的平均组织阻抗低于某预先设置的值时,就会激活组织缝合过程。
37、如权利要求1所述的装置,其特征在于,所述控制设备利用数学模型并根据已知的电流和RF电压,在缝合过程中计算电极的温度、电极之间的组织的温度,以及组织凝集的程度。
38、如权利要求37所述的装置,其特征在于,该计算所得的值是用于调整第一阶段RF电压递增速率以及组织缝合的持续时间。
39、一种生物组织缝合的装置,其特征在于,包括:
(a)在第一阶段向组织缝合器械的电极输送RF电压的装置;
(b)监控组织阻抗,并确定第一阶段中最小组织阻抗的装置;
(c)确定相对组织阻抗的装置,其中,所述相对阻抗等于组织阻抗与该最小组织阻抗值的比值;
(d)监控所述相对组织阻抗值达到某个预先设定的相对组织阻抗值的时间的装置;
(e)当所述相对组织阻抗值达到所述预先设定的相对组织阻抗值时,开始第二阶段的装置;
(f)将第二阶段的持续时间作为第一阶段持续时间的函数进行计算的装置;
(g)在第二阶段向组织缝合器械的电极输送RF电压的装置。
40、如权利要求39所述的装置,其特征在于,在第一阶段向组织缝合器械电极输送的RF电压的振幅按照如下方程式递增:
U=us×tk
其中,U是电压,us是一个常数,t是时间,k也是一个常数,且k<1。
41、如权利要求39所述的装置,其特征在于,所述监控组织阻抗的装置包括测量组织缝合器械的电极之间的RF电压和电流,并利用所述电压除以电流计算组织阻抗的装置。
42、如权利要求39所述的装置,其特征在于,所述预先设定的相对组织阻抗值是作为第一阶段的RF电压值的函数进行计算的。
43、如权利要求39所述的装置,其特征在于,所述预定相对组织阻抗值的范围处于1~1.5之间。
44、如权利要求39所述的装置,其特征在于,当所述相对组织阻抗值达到该预定相对组织阻抗值时,第二阶段输送的RF电压值作为第一阶段输送的RF电压值的函数进行计算。
45、如权利要求39所述的装置,其特征在于,在第二阶段输送的RF电压约为第一阶段结束时所输送RF电压值的50~100%。
46、如权利要求39所述的装置,其特征在于,在第二阶段输送RF电压的装置包括充分地稳定第二阶段输送的RF电压值的装置。
47、如权利要求39所述的装置,其特征在于,进一步包括利用脉冲对第一、第二阶段输送的RF电压进行调制的装置。
48、如权利要求47所述的装置,其特征在于,所述脉冲的频率约为100Hz~60kHz之间,其负载周期约为10~90%。
49、如权利要求47所述的装置,其特征在于,所述脉冲的频率在第一、第二阶段变化。
50、如权利要求39所述的装置,其特征在于,进一步包括利用频率约为100Hz~60kHz的脉冲对第一、第二阶段输送的RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制的装置。
51、如权利要求50所述的装置,其特征在于,进一步包括充分稳定第二阶段输送的RF电压振幅的装置,其中,所述RF电压振幅是作为第一阶段结束时输送的RF电压值的函数进行计算的。
52、如权利要求50所述的装置,其特征在于,所述低频脉冲的频率被定义为第一阶段持续时间的函数。
53、如权利要求50所述的装置,其特征在于,所述低频脉冲的频率的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。
54、如权利要求39所述的装置,其特征在于,在第二阶段输送RF电压的装置包括以所述相对组织阻抗的函数的方式改变RF电压的装置。
55、如权利要求54所述的装置,其特征在于,进一步包括将所述相对组织阻抗充分地稳定在第一阶段结束时达到的相对组织阻抗水平上的装置。
56、如权利要求54所述的装置,其特征在于,第二阶段所输送的RF电压是作为相对组织阻抗的函数的方式进行变化的,其中,当所述相对组织阻抗值大于所述预定相对组织阻抗值时,降低RF电压,而当所述相对组织阻抗值小于所述预定相对组织阻抗值时,提高RF电压。
57、如权利要求39所述的装置,其特征在于,所述在第二阶段向组织缝合器械的电极输送RF电压的装置,包括,根据某预先设置的程序改变RF电压以改变相对组织阻抗的装置。
58、如权利要求39所述的装置,其特征在于,进一步包括利用频率在100Hz~60kHz之间的脉冲对第一、第二阶段输送的所述RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制的装置,同时,还进一步包括充分稳定所述相对组织阻抗在第一阶段结束时达到的相对组织阻抗值水平的装置。
59、如权利要求58所述的装置,其特征在于,所述低频脉冲的频率被定义为第一阶段持续时间的函数。
60、权利要求58所述的装置,其特征在于,所述低频脉冲的频率的定义方式是,使在第二阶段中的脉冲数目约在5~10个之间。
61、如权利要求58所述的装置,其特征在于,稳定所述相对组织阻抗的操作是由一个调节系统装置完成的。
62、如权利要求61所述的装置,其特征在于,所述调节系统装置通过按预先确定的数量改变RF电压的方式,稳定相对组织阻抗,对RF电压的调整是根据相对组织阻抗的变化符号进行的。
63、如权利要求39所述的装置,其特征在于,进一步包括利用频率在100Hz~60kHz之间的脉冲对第一、第二阶段输送的所述RF电压进行调制,并利用低频脉冲进一步对第二阶段输送的RF电压进行调制的装置,同时,还进一步包括对RF电压进行调整,以便根据某预先设置的程序改变相对组织阻抗的装置。
64、如权利要求63所述的装置,其特征在于,改变所述相对组织阻抗的操作是由一个调节系统装置完成的。
65、如权利要求39所述的装置,其特征在于,进一步包括:监控组织缝合、终止组织缝合,以及如果在第一阶段输送的RF电压达到了某个预先设定的RF电压水平,以及/或者所述相对组织阻抗未能达到预先设定的相对组织阻抗值时,向用户发出一个信号的装置。
66、如权利要求39所述的装置,其特征在于,进一步包括:监控组织缝合、终止组织缝合,以及当所述组织阻抗达到该组织缝合器械电极之间发生短路时的阻抗时,向用户发出信号的装置。
67、如权利要求39所述的装置,其特征在于,进一步包括:监控组织缝合,以及当第二阶段结束后完成组织缝合操作,并且被缝合的组织充分冷却之后,向用户发出信号的装置。
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- 2003-02-13 CN CNB038049384A patent/CN100484493C/zh not_active Expired - Fee Related
- 2003-02-13 JP JP2003569239A patent/JP4376631B2/ja not_active Expired - Lifetime
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- 2003-02-13 UA UA20040907571A patent/UA77064C2/uk unknown
- 2003-02-13 WO PCT/US2003/004679 patent/WO2003070284A2/en active Application Filing
- 2003-02-13 RU RU2004127930/14A patent/RU2325132C2/ru not_active IP Right Cessation
- 2003-02-13 AU AU2003216294A patent/AU2003216294B2/en not_active Expired - Fee Related
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2010
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Cited By (5)
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CN102846366A (zh) * | 2011-06-30 | 2013-01-02 | 厄比电子医学有限责任公司 | 用于生物组织的优化凝固的方法和设备 |
CN102846366B (zh) * | 2011-06-30 | 2016-08-17 | 厄比电子医学有限责任公司 | 用于生物组织的优化凝固的方法和设备 |
CN105395247A (zh) * | 2014-09-05 | 2016-03-16 | 爱尔博电子医疗仪器股份有限公司 | 一种用于生物组织的接触凝固的装置 |
CN105395247B (zh) * | 2014-09-05 | 2019-02-22 | 爱尔博电子医疗仪器股份有限公司 | 一种用于生物组织的接触凝固的装置 |
US10413348B2 (en) | 2014-09-05 | 2019-09-17 | Erbe Elektromedizin Gmbh | Arrangement for contact coagulation of biological tissue |
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AU2010201919A1 (en) | 2010-06-03 |
CA2476615A1 (en) | 2003-08-28 |
UA77064C2 (en) | 2006-10-16 |
RU2004127930A (ru) | 2005-04-10 |
RU2325132C2 (ru) | 2008-05-27 |
EP1482850A4 (en) | 2011-01-05 |
WO2003070284A3 (en) | 2004-04-08 |
AU2003216294A1 (en) | 2003-09-09 |
EP1482850A2 (en) | 2004-12-08 |
AU2003216294B2 (en) | 2010-03-04 |
WO2003070284A2 (en) | 2003-08-28 |
US6733498B2 (en) | 2004-05-11 |
US20030158551A1 (en) | 2003-08-21 |
JP4376631B2 (ja) | 2009-12-02 |
CN1638700A (zh) | 2005-07-13 |
JP2005517498A (ja) | 2005-06-16 |
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