CN101045015B - 超声外科系统及方法 - Google Patents

超声外科系统及方法 Download PDF

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CN101045015B
CN101045015B CN2007101016312A CN200710101631A CN101045015B CN 101045015 B CN101045015 B CN 101045015B CN 2007101016312 A CN2007101016312 A CN 2007101016312A CN 200710101631 A CN200710101631 A CN 200710101631A CN 101045015 B CN101045015 B CN 101045015B
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K·L·豪泽
W·T·多诺弗里奥
F·B·斯图伦
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Abstract

一种具有超声单元的超声外科系统，该超声单元包括与超声发生器可操作地连接的器械，其中所述器械具有位于轴的远端的超声端部执行器。所述系统还包括定位单元，定位单元包括适于可释放地保持所述器械的可动臂，从而操作者可以引导定位单元将端部执行器定位在患者体腔内的手术部位，从而进行多个外科任务。所述系统还包括可操作地与超声单元和定位单元连接的控制单元，其中所述控制单元被编入用于进行外科任务的外科子程序。所述系统还包括与控制单元可操作地相连的用户界面，用于启动外科子程序的操作周期，从而在操作周期内自动进行所述外科任务。

Description

超声外科系统及方法
技术领域
本申请涉及超声外科器械，更具体而言，涉及具有切割和凝结组织的端部执行器的超声外科器械。本申请还涉及机器人外科系统，更具体而言，涉及与超声外科器械一起使用的机器人外科系统。
背景技术
外科医生在外科手术中使用超声器械来切割和凝结组织。在超声器械的谐振频率下压电元件被电激励产生振动，所述振动通过谐振器传输并被放大产生具有相同频率的机械、驻波振动。所述器械的超声传输组件具有细长的传输波导管，其将所述振动传输至器械远端的端部执行器(例如，切割刀片)。超声外科器械的一个例子是可从EthiconEndo-Surgery，Inc.，Cincinnati，Ohio获得的Harmonic
Figure G200710101631220070510D000011
Figure G200710101631220070510D000012
凝结剪。
近年来，已经开发微创机器人系统，其用于某些外科过程包括管状动脉旁路移植和胆囊切除术。机器人系统提供很多有价值的益处，其例如通过增加灵敏度和消除手颤抖基本上降低了完成某些外科手术的技术需求。机器人系统也允许外科医生在遥控位置进行手术，其中遥控可被理解为离患者“超过臂的长度”的任何地方。机器人外科系统的一个例子是为DAVINCI，其可从Intuitive Surgical Inc.，Mountain View，California获得。
授予Anderson等人、名称为“Robotic Surgical Tool with UltrasoundCauterizing and Cutting Instrument”的美国专利No.6,783,524公开了一种安装在机器人外科系统例如DA VINCI的可动臂上的超声外科器械。公开的增强机器人外科手术的方法通常包括将器械连接机器人外科系统，将器械的端部执行器与手术部位的组织接触，将超声能量传送至组织。通常，公开的机器人系统允许外科医生从遥控位置直接控制器械的运动和启动。
即使外科技术具有这种进步，但是外科医生进行一些外科手术的特别步骤仍然需要相当强的技术。例如，为了超声凝结脉管例如胆囊的胆囊管，外科医生可以将超声刀片相当大的表面压在管道上，对管道施加轻的夹持力，在提供中等水平的超声功率时对管道上的处理区域中的超声端部执行器扫描。接着，为了切割管道，外科医生可以将刀片刃置于管道上，在保持刀片固定时对管道施加高的夹持力，并提供高水平的超声功率。在外科手术中外科医生可以对患者重复这些步骤几次。
为了减少进行某些外科手术的时间以及改进外科手术结果，外科医生会采用使用目前的外科系统通常不可行的各种方法。例如，为了搅拌和/或循环组织内的液体以加快液体干燥，当提供超声能量时，很多外科医生对组织施加快速脉冲的夹持力，从而缩短凝结组织的时间。外科医生也习惯在合适的持续时间内一致地施加合适功率水平的超声能量，主要为了避免伤害，例如对组织的横向热损伤，并且加快手术过程，同时确保组织密封件是止血剂。外科医生主要依赖他们的自然感觉来估计对组织的夹持力以及应提供给组织的超声能量的功率水平/持续时间。显然，如果外科医生使用机器人外科系统并与患者隔开时，某些感觉反馈会大大减少。
显然，即使可能，外科医生也难以以非常协调的方式进行多个外科任务，其中所述任务可以例如包括，扫描组织上的超声刀片，旋转刀片，使夹持力脉动，以及以不同功率水平提供超声能量。
因此，需要一种超声外科系统以及在外科手术中超声处理患者组织的方法，其中某些外科任务可以自动并且一致地进行，从而降低外科医生进行所述任务所需的技术水平，改进外科手术结果，减少外科手术时间，并进一步增强远程进行外科手术的能力。
发明内容
在一方面，超声外科系统具有超声单元，所述超声单元包括与超声发生器可操作地连接的器械，其中所述器械在轴的远端具有超声端部执行器。所述系统还包括定位单元，所述定位单元包括适于可释放地保持所述器械的可动臂，从而操作者可以引导定位单元将端部执行器定位在患者体腔内的手术部位上，用于进行多个外科任务。所述系统还包括与超声单元和定位单元可操作地连接的控制单元，其中控制单元编入用于进行多个外科任务的外科子程序。所述系统还包括与控制单元可操作地连接的用户界面，用于启动外科子程序的操作周期，从而在操作周期内自动进行外科任务。
在另一方面，用于超声处理外科患者的组织的方法包括提供在前段限定的超声外科系统、给控制器械编入用于进行多个外科任务的外科子程序，将器械的端部执行器定位在患者体腔内的手术部位内，并启动控制单元的外科子程序，从而系统根据外科子程序自动进行外科任务。
在另一方面，用于超声处理外科患者的组织的方法包括提供在前述方面限定的超声外科系统，该系统还包括具有至少一个传感器并具有相关的传感器电路的反馈系统，所述传感器位于超声单元和定位单元中的至少一个内，其中反馈系统可操作地连接控制单元，在操作周期内与器械的操作性能参数相关的反馈信号可以从传感器传递至控制单元，从而控制系统可以处理反馈信号并根据外科子程序进行响应。所述方法还包括给控制单元编入用于进行多个外科任务外科子程序、将器械的端部执行器定位在患者体腔内的手术部位、启动控制单元的外科子程序，从而所述系统自动进行外科任务、处理反馈信号并根据外科子程序对反馈信号进行响应。
本发明的第三种实施方式为基于能量的医疗处理系统，包括具有两个夹紧元件的基于能量的夹持凝结器，所述夹紧元件适于凝结夹在两个夹紧元件之间的患者组织，其中两个夹紧元件中的至少一个包括适于用作温度传感器，用于测量被夹住的患者组织的温度。
本发明具体涉及：
(1)一种超声外科系统，包括：
超声单元，所述超声单元包括与超声发生器可操作地连接的器械，其中所述器械包括端部执行器；
包括可动臂的定位单元，其中所述可动臂适于保持所述超声单元的所述器械；
控制单元，其与所述超声单元和所述定位单元通讯，所述控制单元可编有用于进行外科任务的外科子程序；以及
与所述控制单元通讯的用户界面，所述用户界面适于启动所述外科子程序的操作周期，从而在所述操作周期内自动进行所述外科任务。
(2)如第(1)项所述的超声外科系统，其中，所述可动臂可释放地保持所述器械。
(3)如第(1)项所述的超声外科系统，其中，所述外科任务包括根据所述外科子程序的超声功率水平曲线向所述端部执行器提供能量。
(4)如第(3)项所述的超声外科系统，其中，所述外科任务包括使所述端部执行器扫描身体组织。
(5)如第(3)项所述的超声外科系统，其中，所述外科任务包括根据所述外科子程序的纵向扫描曲线使所述端部执行器在处理区域内沿纵向扫描。
(6)如第(1)项所述的超声外科系统，其中，所述端部执行器包括夹紧元件和超声刀片中的至少一个。
(7)如第(6)项所述的超声外科系统，还包括具有力传输组件的启动单元，所述力传输组件可操作地连接到所述夹紧元件上并与所述控制单元通讯，其中所述力传输组件适于启动所述夹紧元件并向身体组织施加可变的夹持力。
(8)如第(1)项所述的超声外科系统，其中，所述端部执行器包括超声刀片。
(9)如第(8)项所述的超声外科系统，还包括具有刀片旋转组件的启动单元，所述刀片旋转组件可操作地与所述超声刀片连接，从而可以启动刀片旋转组件，使刀片绕中心轴线旋转，其中所述外科任务包括根据所述外科子程序的刀片旋转曲线使所述超声刀片绕所述中心轴线旋转。
(10)如第(9)项所述的超声外科器械，其中，所述超声刀片包括绕所述中心轴线布置并限定刀片横截面轮廓的多个刀片表面部分，其中所述超声刀片旋转，以使任何一个所述表面部分可以朝向组织定位。
(11)如第(10)项所述的超声外科系统，其中，所述刀片表面部分包括相对平的表面部分、相对圆的表面部分、相对窄的表面部分和边缘表面部分中的至少一个。
(12)如第(1)项所述的超声外科系统，其中，所述定位单元为外科机器人设备，其具有与所述可动臂通讯的工作台。
(13)如第(1)项所述的超声外科系统，还包括反馈系统，所述反馈系统包括定位在所述超声单元、所述定位单元和所述启动单元中的至少一个内的至少一个传感器并具有相关联的传感器电路，其中所述反馈系统可操作地与所述控制单元连接，在所述操作周期内与所述器械的操作性能参数相关的反馈信号可以从所述传感器传递至所述控制单元，从而所述控制系统可以处理所述反馈信号并根据所述外科子程序进行响应。
(14)如第(13)项所述的超声外科系统，其中，所述反馈系统包括电阻抗测量电路，用于测量被处理的组织的电阻抗。
(15)如第(13)项所述的超声外科系统，其中，所述反馈系统包括声阻抗测量电路，用于测量被处理的组织的声阻抗。
(16)如第(13)项的超声外科系统，其中，所述反馈系统包括温度传感器和温度电路，用于测量被处理的组织的温度、所述端部执行器的温度、靠近所述被处理的组织的物体的温度、以及围绕所述被处理的组织的流体温度中的至少一个。
(17)一种超声外科系统，包括：
超声单元，其包括与超声发生器可操作地连接的器械，其中所述器械具有位于轴远端的超声端部执行器；
包括可动臂的定位单元，所述可动臂适于可释放地保持所述器械，从而操作者可以引导所述定位单元将所述端部执行器定位在患者体腔内的手术部位，从而进行多个外科任务；
可操作地与所述超声单元和定位单元连接的控制单元，其中所述控制单元编有用于进行所述外科任务的外科子程序；
与所述控制单元可操作地相连的用户界面，用于启动所述外科子程序的操作周期，从而在所述操作周期内自动进行所述外科任务；以及
反馈系统，其包括至少一个传感器并具有相关的传感器电路，所述至少一个传感器位于超声单元和定位单元中的至少一个内，其中所述反馈系统可操作地连接所述控制单元，在所述操作周期内与所述器械的操作性能参数相关的反馈信号可以从所述传感器传递至所述控制单元，从而所述控制系统可以处理反馈信号并根据所述外科子程序进行响应。
(18)一种用于超声处理患者组织的方法，所述方法包括：
提供包括超声单元的超声外科系统，所述超声单元包括与超声发生器可操作地连接的器械，所述器械包括端部执行器、定位单元、控制单元、以及用户界面，所述定位单元包括可动臂，所述可动臂适于保持所述超声单元的所述器械，所述控制单元与所述超声单元和所述定位单元通讯，所述用户界面与所述控制单元通讯；
为所述控制单元编制用于进行外科任务的外科子程序；
将所述器械的所述端部执行器定位在所述患者体腔内的手术部位；以及
启动所述外科子程序，从而所述超声外科系统根据所述外科子程序自动进行所述外科任务。
(19)如第(18)项所述的方法，其中，所述外科任务包括根据所述外科子程序的超声功率水平曲线向所述端部执行器提供能量。
(20)如第(19)项所述的方法，其中，所述外科任务包括根据所述外科子程序的扫描曲线使所述端部执行器扫描所述组织。
从下面的说明书、附图和后附权利要求将更清楚了解超声外科系统以及在外科过程中超声切割和凝结患者组织的方法的这些方面以及其它方面。
附图说明
图1是现有技术的机器人外科器械的透视图；
图2是用于图1所示的机器人外科器械的现有技术的超声外科器械的透视图；
图3是根据一个方面的超声外科器械的局部切开的俯视图，其中所述器械包括用于操作端部执行器的机动启动单元；
图4是图3所示超声外科器械的远端部分的透视图；
图5是显示超声外科系统的方框图，根据第一方面的用实线方框表示，根据第二方面的用所有的方框表示；
图6是图4所示器械的远端部分的侧视图；
图7是图4所示器械远端部分的俯视图；
图8是沿图4所示器械沿图7的线8-8截取的横截面图；
图9是描述根据超声外科系统的一个方面在示例性操作周期内提供给超声端部执行器的超声功率与时间的关系的曲线图；
图10是描述根据超声外科系统的一个方面在操作周期内端部执行器的夹紧元件角度与时间的关系的曲线图；
图11是描述根据超声外科系统的一个方面在操作周期内端部执行器的横向位置与时间的关系的曲线图；
图12是描述根据超声外科系统的一个方面在操作周期内端部执行器的纵向位置与时间的关系的曲线图；
图13是描述根据超声外科系统的一个方面在操作周期内端部执行器的刀片的旋转位置与时间的图；
图14是描述根据超声外科系统的一个方面在操作周期内提供给端部执行器的超声功率与时间的关系的曲线图，与图9所示的图相同；
图15是描述根据超声外科系统的一个方面在操作周期内测量的组织上的端部执行器的夹持力反馈与时间的关系的曲线图；
图16是描述根据超声外科系统的一个方面在操作周期内测量的电阻抗反馈与时间的关系的曲线图；以及
图17是描述根据超声外科系统的一个方面在操作周期内测量的声阻抗反馈与时间的关系的曲线图。
具体实施方式
下面的说明书涉及超声外科系统以及根据自动外科子程序进行外科过程的方法。所述系统和方法可以特别用于超声切割和凝结患者软组织，但是所述系统和方法也可适用于其它类型的外科过程。外科医生可以在外科过程中启动外科子程序从而同时和/或以协同的方式完成多个外科任务，其中外科任务可以包括扫描组织上的器械的超声刀片，旋转刀片，启动夹紧元件，以及施加各种功率水平的超声能量并获得与器械的性能相关的反馈信号。
这里描述的超声外科系统可以包括外科机器人器械例如图1所示的现有技术的DAVINCI系统(Intuitive Surgical，Inc)或者与其协同使用。机器人器械，总体用10表示，在先前引用的美国专利No.6,783,524中公开，在这里其全部内容通过引用并入本文。机器人设备10包括控制台12和外科工作台20。控制台12包括用于显示手术部位图像的图像显示模块14、操作者可以将他/她的前臂靠在其上面的支撑物16、以及放置两个主控制装置(未显示)的空间18。当使用控制台12时，外科医生可以坐在控制台12前面的椅子上，通过显示模块14观察手术部位，并且每只手握住一个主控制器，同时将前臂靠在支撑16上。
控制台12通常连接到工作台20上，使得来自主控制器械的指令可以传递至工作台20。工作台20是可移动的，可以靠近手术患者设置。控制台12可以设置成远离工作台20，但是通常控制台12与工作台20位于同一操作空间。
根据各个方面，工作台20可以包括至少三个机器人臂组件22、26、27(也称作可动臂)，其中的一个可以构造成支撑图像捕获装置24，其他的可以构造成支撑外科器械28。工作台20与控制台12的连接通常能使显示模块14显示由图像捕获装置24捕获的图像，并能控制可动臂22、26、27。
外科器械28通常包括细长轴，用于在内窥镜下接近患者体内的手术部位，其中所述轴具有端部执行器，适用于特定的外科任务。器械28可释放地安装在可动臂22、26、27上的腕状机构上，以便外科医生可以使用控制台12在不同的方向上移动每个器械28(即，臂22、26、27具有多个自由度)。
图2是图1所示的外科器械28的可替代方面的透视图，其在美国专利No.6,783,524中详细描述。所述方面，总体用30表示，包括具有盖34的器械底部32。器械30也包括从器械底部32沿器械轴线38向远端延伸的轴36。轴36包括护套40。端部执行器42连接至轴36的远端并包括与夹具46协同配合的超声刀片44。超声换能器48安装在底部32的近端，能量/控制缆线50可操作地连接到传统超声外科发生器，例如United States Surgical Corporation of Norwalk，Connecticut制造的Auto SonixTM发生器(未显示)上。
当坐在控制台旁时，外科医生可以将器械30的远端部分导入并定位在患者的体腔内，操纵并超声处理其中的组织。当坐在机器人设备10的控制台12旁时，外科医生可以操纵端部执行器42到患者内部的手术部位，启动端部执行器42以夹住组织并向刀片44提供能量以切割和凝结组织。
图3是超声外科器械52的剖面俯视图，其由外科医生握持或可释放地安装到机器人设备的可动臂上。器械52可以包括底部54和从底部54向远端延伸的细长轴56。轴56的远端上的端部执行器58可以包括夹紧元件62(也被称作夹钳)和超声刀片60。图4是端部执行器58的详细透视图。刀片60通过波导管66(图3)可操作地连接到从底部54的远端延伸的超声换能器64上。换能器64、波导管66和刀片60的结构和超声操作与先前引用的组件中公开的外科超声传输组件类似。换能器64可适于相对于底部54绕中心轴线68旋转，以便刀片60相对于夹紧元件62绕轴线68旋转，从而由于这里描述的原因允许夹紧元件62夹在刀片60的各个表面部分上。
器械52可以包括具有力传输组件80的启动器械81和刀片旋转组件70。力传输组件80允许夹紧元件62在箭头“C”表示的方向上电控运动。刀片旋转组件70允许刀片60在箭头“R”表示的两个方向上绕轴线68电控旋转。这些运动可以直接被外科医生控制或如这里将描述的自动进行。
在一个方面，力传输组件80可以包括可操作地连接到远程控制器(未显示)的第一电动机82。组件80可以包括第一驱动机构87，其可操作地使电动机82与轴56的护套57接合，从而电动机82的电启动根据电动机82的旋转方向在远端或近端方向上移动护套57。护套57的远端可以操作地与夹紧元件62连接，从而护套57向远端的平移使夹紧元件62朝刀片60移动，护套57向近端的平移使夹紧元件62移离刀片60。驱动机构87可以包括很多常规机构中的任何一种，用于将电动机82的旋转转化成护套57的平移。如图3所示，驱动机构87可以包括与电动机82连接并与从动件86可操作地接合的导螺杆84，所述从动件86与护套57的近端连接并在形成于底部54上的导轨89之间被引导。
仍参考图3所示的方面，刀片旋转组件70可以包括与远程控制器(未显示)操作连接的第二电动机72。组件70可以包括使电动机72与超声换能器64可操作地接合的第二驱动机构77，从而电动机72的电启动导致换能器64绕轴线68在任一方向旋转，从而使波导管66和刀片60绕轴线68旋转。能量/控制缆线90从换能器64向近端延伸，可以操作地与用户界面(未显示)连接，如将描述的一样。第二驱动机构77可以包括很多常规机构中的任何一种，用于将电动机72的旋转转化成换能器64的旋转。如图3所示，驱动机构77可以包括与电动机72连接并与正齿轮76啮合的小齿轮74，所述正齿轮76与换能器64连接。电动机72可以被电启动，以致当缆线90在任一方向弹性扭转时，换能器64绕轴线68旋转+/-180度。
第一和第二电动机72，82可以选自大量可商购的DC伺服电动机或满足多种系统需要的其它类型的电动机，这些需要包括双向轴转动、足够的扭距和转速调制、微处理器控制、尺寸和成本。
如图4所示，器械58的远端部分和相应的超声传输器械可以与授予Bishop等人、名称为“Coagulator Apparatus Having IndexedRotational Positioning”的美国专利No.5,954,736中公开的类似，在这里其全部内容通过引用并入本文。器械58可以通过例如购自EthiconEndo-Surgery，Inc.，Cincinnati，OH，型号为GEN04的超声发生器(未显示)超声驱动。
在器械52的另一方面，如美国专利No.6,783,524从第15栏第29行开始所公开的，用于远程启动夹紧元件62的力传输组件80可以由外科器械80的夹钳82所提供。
外科器械52及其各个方面可以包括在图5所示的超声外科系统100中。系统100可以根据一种或多种自动外科子程序使用，以在患者的外科手术中协同操作进行多个外科任务。
在图5中，系统100的第一方面用实线方框表示，第二方面用所有的方框表示。外科医生或操作者可以使用系统100，以例如根据预定外科子程序自动凝结和切割组织。在外科手术前，所有或部分外科子程序可以由操作者编入系统100中。可选择地，所有或部分外科子程序可以已经被编入系统100中。
系统100通常可以包括用户界面102、可编程控制单元104、超声单元106，定位单元108和启动单元110。超声单元106可以包括超声发生器112和超声外科器械114。(在下列对系统100的描述中，对于端部执行器刀片和夹紧元件，适用图4所示的端部执行器58、刀片60和夹紧元件62，但是很多其它类型的超声端部执行器也可以适于与器械114一起使用)。定位单元108可以包括用于将器械114定位和定向在患者手术部位的可动臂116。启动单元110可以包括用于操作器械114上的夹紧元件60的力传输组件118和使器械114上的超声刀片绕中心轴旋转的刀片旋转组件120。系统100可以包括一机器人设备例如图1所示的机器人设备10，或者与其结合使用。可选择地，可以使用不具有这种机器人设备的系统100，而是需要外科医生以常规方式握持和定位超声外科器械，接着启动自动手术子程序以进行某些外科任务。
用户界面102可以包括具有一个或多个用于远程操作器械114的控制器的控制箱(未显示)、可操作地与内窥镜或其它类型的用于显示手术部位的图像捕获器械相连的监测器(未显示)、用于启动和终止编入控制单元104的机器人外科子程序的一个或多个控制器。用户界面102可以远离或靠近患者设置。可选择地，所有或一些用户界面102可以位于器械114上或系统100的其它部件上。
可编程控制单元104可以包括可编程有同时和/或协同进行一个或多个外科任务的至少一个外科子程序的微处理器。子程序可以自动控制一个或多个外科任务，包括移动刀片，给予刀片超声能量，启动夹紧元件和响应反馈信号。子程序的持续时间在这里被限定为一个操作周期，其可以例如在零点几秒至几秒之间变化。
控制单元104可以设有一个或多个预先编入微处理器中的外科子程序，以致外科医生可以例如在外科手术之前或期间，通过启动用户界面102上的控制器选择和初始化子程序。例如，外科医生可以确定直径大约3mm的血管将被凝结和切割。接着子程序自动指示器械在特定的时期内提供特定的超声能量功率水平，使超声刀片扫描组织，并根据已知有效的处理过程启动夹紧元件。可选择地，控制单元104可以包括多种常规数据输入装置中的任意一种，其允许医生在进行外科手术之前给微处理器编程。当来自编程软件并在监测器上显示的指令指示时，这种装置允许使用例如软盘、闪速存储器装置或通过键入数据来输入数据。
超声单元106的超声发生器112可以是传统的超声发生器，例如GEN04(Ethicon Endo-Surgery，Inc.)发生器。器械114可以可操作地与发生器112连接，并且可释放地安装在定位单元108的可动臂116上。器械114可以是图2所示的超声外科器械30以及图3和4所示的超声外科器械52方面中的任何一种或其等价物。为了将器械114的端部执行器定位在手术部位，外科医生可以操作用户界面102以控制臂116的移动。
如前面所述，机器人设备10(图1)可以适于定位器械114和启动器械114的端部执行器。控制单元104可以操作地与设备10连接，以致控制单元104根据外科子程序控制机器人设备10以移动器械114。例如，当向组织提供超声能量以提供较大的止血范围时，子程序可以指引设备10的可动臂使器械114的超声刀片横向(横向)和/或纵向扫描。或者当为了增强组织接缝的质量，向刀片提供超声能量时，子程序可以指引设备10每秒多次可逆地启动器械114上的夹紧元件。
定位单元108可以包括其它类型的动力机构，用于使超声刀片产生精确的横向和/或纵向移动以及当向刀片提供超声能量时，启动器械114的夹紧元件。例如，各种类型的电动机、电磁螺线管、气动致动器、液压致动器、电动镍/钛记忆合金机构和其它装置可以结合到器械114中并可操作地与控制单元104连接，用于根据外科程序定位和启动器械114。此外，器械114可以被手持，定位单元108可以是外科医生或其它人操作者而不是机器人设备。
根据外科子程序，启动单元110的力传输组件118启动器械114的夹紧元件，从而对被夹在超声刀片上的组织施加调节力。力传输组件118可以包括定位单元108的可动臂116的力传输元件，其中力传输元件机械连接到器械114上，用于启动例如先前引用的美国专利号6,783,524和6,352,532中描述的夹紧元件。在此美国专利No.6,352,532的全部内容通过引用并入本文。可选择地，力传动组件118可以包括一个或多个安装在例如器械114的内部的部件，与对图3中的器械52描述的一样。
刀片旋转组件120可与图3所示的刀片旋转组件80类似。刀片旋转组件120使超声刀片绕中心轴旋转，以致组织可以被夹在刀片的各种表面部分上。例如，第一表面部分可以比较平，用于凝结大面积组织，而第二表面部分可以具有相对尖锐的边缘，用于将超声能量施加到组织的狭窄区域并切割组织。例如，外科子程序开始可以引导刀片使第一表面部分朝向组织，从而在血管上形成宽区域的凝结组织，外科子程序的末期可以引导刀片使第二表面部分朝向组织，从而切割宽凝结区域的中心。
除了电动致动器，可以适用于力传输组件118和刀片旋转组件120的其它类型的致动器，例如包括电磁线圈致动器、液压致动器和气动致动器。
在图5中方框表示的超声外科系统100的第二方面包括第一方面的元件，另外还有反馈系统122。反馈系统122可以包括至少一个传感器122，用于在操作周期中测量与超声外科系统的操作性能相关的操作参数。
在一个方面，反馈系统122可以包括测量夹紧元件的机械夹持力的力传感器126。力传感器126可以是本领域众知的很多力传感器中的任何一种，包括设置在力传输组件118的力传动部件(未显示)上的夹紧元件上的应变仪或压电传感器。力传感器126可以与控制单元104电连接，控制单元104可以在操作周期中处理来自力传感器126的反馈信号。接着控制单元104可以根据外科子程序并基于力反馈增大超声功率水平、夹持力和/或刀片移动。如果超过预定的力，为了防止伤害患者或造成器械114损伤，控制单元104也可以停止外科子程序。
力传感器126可使控制单元104能够控制启动单元110提供夹在夹紧元件和刀片之间的组织的多种夹持力与时间关系曲线中的任何一种。例如，外科子程序可以控制夹紧元件的启动以提供操作周期的一个或多个部分期间的特定离散力。例如，在一方面离散力可以是脉动或以大约1-10赫兹的频率重复施加。可选择地，例如，外科子程序可以引导夹紧元件的启动，以在操作周期期间提供上升和/或下降倾斜的力曲线或抛物线力曲线。可选择地，当在凝结组织期间刀片扫描组织的处理区域和/或绕中心轴旋转时，可以施加比较轻的力。接着，为了切割处理区域中央的组织，可以施加比较重的力。
在另一方面，反馈系统122可以包括电阻抗测量电路128，用于测量在操作周期中被端部执行器处理的组织的电阻抗。由于当组织凝结时，活组织的电阻抗通常增加，当其被超声处理时测量通过组织的电流提供凝结水平的指示。夹紧元件和刀片，两者都是电导体，可以电连接到电阻抗测量电路上，以通过夹在夹紧元件和刀片之间的组织的电流可以被控制单元104所监测。在一个方面，例如外科子程序可以被编程，从而当电阻抗达到预定大小时，关掉超声能量并且停止子程序。
在另一方面，反馈系统122可以包括声阻抗测量电路130，例如本领域公知的电路，用于测量被超声处理的组织的声阻抗。声阻抗可以表征为材料传输声波的能力。通常，当声阻抗增加，声音通过材料的速度降低。由于材料凝结，组织弹性降低，组织密度增加，从而降低声阻抗。声阻抗测量电路130可以自然位于超声单元106的发生器112的内部。控制电路104可以处理来自电路130的反馈信号并基于声反馈修改或停止外科子程序。
而在另一方面，反馈系统122可以包括温度传感器132和温度测量电路(未显示)。为了测量刀片或夹紧元件、处理组织、靠近处理组织的物体或围绕处理组织的流体的温度，温度传感器132可以安装在器械114的端部执行器上或其附近。温度传感器132可以是热电偶、热敏电阻、红外温度传感器或本领域公知的很多其它温度传感器中的任何一种。温度反馈信号可以被传递至控制单元104，其可以处理信号以修改或停止外科子程序。
前述反馈系统122的方面的任何结合可以包括在超声外科系统100中，以将反馈信号传递到控制单元104，从而控制单元104可以在操作周期内处理信号并根据外科子程序进行响应。
图6-8描述当器械114的刀片根据外科子程序由超声提供能量时，可以自动操作的端部执行器运动的实施例。所述运动可以包括夹紧元件角度调节，端部执行器在x-轴方向的横向定位，端部执行器在z-轴方向的纵向定位，以及刀片绕z-轴的旋转。端部执行器的横向和纵向定位也被称作“扫描”。这里这些运动被限定为适合于图4所示的端部执行器58，但是它们也适合具有刀片和夹紧元件的其它超声端部执行器。对于只有刀片而没有夹紧元件的端部执行器，不包括刀片旋转和夹紧元件角度调节的运动。
图6是图4的器械52的远端部分的侧视图，显示位于原点142的纵坐标系统的y-轴和z-轴。中心轴线68延伸穿过轴56并沿着z-轴延伸。夹紧元件62枢转连接到轴56的枢轴点140，并可以被设置成相对于刀片60呈夹紧元件角度“A”。夹紧元件角度A可以远程调节，以例如通过部分启动夹紧元件62大约在0到60度范围内变化。当启动夹紧元件62朝靠近刀片60的方向移动时，夹紧元件62夹住位于锯齿状部分144和刀片60之间的组织，平均夹持力“F”垂直于夹紧元件62并靠近锯齿状部分144的中心。当夹紧元件角度A大约为0时，例如当夹住薄组织时，平均夹持力F大致穿过原点142指向。
图7是图2所示的器械52的远端部分的俯视图，显示纵坐标系统的原点142，z-轴和x-轴。在某些情况下，外科医生可以优选依次处理组织的大区域，以例如提供凝结组织的安全范围，用于适当的止血。外科医生可以超声处理在x-轴横向由“+DX”和“-DX”限定以及在z-轴纵向由“+DZ”和“+DZ”绕原点142限定的处理区域146(也被称作中央处理区域)的组织。
当以低功率水平向刀片60提供超声能量并且保持夹紧元件角度A呈所需的开口时，端部执行器58可以在处理区域146内横向和/或纵向扫描。可选择地，当夹紧元件角度A接近0并向组织施加大夹紧力时，可以以高功率水平向刀片60提供超声能量。当向刀片60提供能量时，为了搅动并循环能量供应附近的组织液，可以重复地例如以快速脉冲方式施加夹持力。本领域普通技术人员可以理解，夹紧、提供能量和扫描具有多种不同组合用于处理多种不同类型的外科条件下的不同类型的组织。
图8是当夹紧元件角度A为0时，沿图7的端部执行器58的线8-8得到的横截面图。刀片60可以包括共同限定刀片轮廓15的第一表面148、第二表面150、第三表面152、第四表面154和第五表面156。图5显示了刀片轮廓160的一个方面，其例如对在胆囊切除术中横切胆囊的囊管特别有用。根据外科用途和器械的其它需要刀片轮廓160可以具有很多其它的几何形状。
参考图6和8，刀片14可绕z-轴旋转，以便当组织保持在其之间时，任何一个表面148，150，152，154，156或表面之间的一个边缘可以与夹紧元件62连接。刀片60可以绕z-轴在正方向“+RZ”和负方向“-RZ”上旋转。例如，当希望对组织施加高度集中力以例如切割时，刀片60可以旋转以致刃158接合组织。可选择地，当例如凝结期间希望在大面积上分散夹紧力时，刀片60可以旋转，以使表面148接合组织。或者当表面150接合组织时，刀片60可以在一定角度范围内来回旋转，以当向刀片60提供超声能量时产生“滚动(rolling)”效应。对本领域普通技术人员来说显而易见的是，可以设计旋转刀片60和向刀片60提供能量的很多不同的组合，用于在很多不同外科条件下迅速以止血的方式切割和/或凝结不同类型的组织。
为了加速和/或增强组织处理区域146(图7)内的组织处理，根据外科子程序，当向刀片60提供能量并施加夹持力时，控制单元104可以被编程以沿着预定路径引导器械114精确移动。预定路径可以包括x-方向的横向扫描、y-方向的纵向扫描和刀片绕z-轴的旋转的任何组合。图9-17是描述在操作周期中，根据示例性外科子程序操作控制系统100的图，其中对组织进行外科手术。显示的曲线没有准确值，意欲显示相对的参数大小和同时进行的外科任务的定时。图中显示的总时间可以例如大约在2至10秒的范围。很多其它外科子程序是可能的，其可以根据预想的外科条件设计并编入控制单元104。
在图9以及在图14显示了超声功率与时间的曲线图，显示操作周期内的超声“U/S”功率(瓦)与时间“T”(秒)的关系。超声功率是超声频率和振幅的函数。传递至组织的超声功率因此可以通过改变超声频率和振幅，以及通过选择施加到组织的夹持力(压力)被有效控制。如图所示可以间歇施加超声功率以在端部执行器的每次重新定位之间凝结组织，并可以切割组织，在此期间超声功率可以达到最大值，例如近似20瓦。
图10显示了和图9所示的操作周期相同的夹紧元件角度与时间的关系。当施加超声功率时，如所示夹紧元件角度A随时间变化，显示当向组织施加夹持力时如何只施加超声功率，如图6所示。
图11和12显示的图描述外科子程序如何可以同时引导端部执行器在x-轴方向(横向位置，DX)和z-轴方向(纵向位置DZ)准确运动，如对图7的描述。图11描述横向位置与时间的关系，图12描述和图9所示相同的操作周期内纵向位置与时间的关系。
图13显示的图描述与图9所示相同的操作周期内刀片旋转与时间的关系。外科子程序表示的命令引导刀片60绕z-轴(刀片旋转，RZ)旋转，如对图8的描述。
图15，16和17是显示控制系统60(图5)的反馈系统122提供的示例性反馈信号的图，其在图14所示的操作周期内同时被测量。如前面所述，控制单元104可以处理反馈信号并根据外科子程序进行响应。
根据一个方面，用于超声处理外科患者的组织的方法可以包括提供根据图5描述的第一方面的超声外科系统，将外科子程序编入控制器械用于完成多个外科任务，将器械的端部执行器定位在患者的体腔内的手术部位，初始化控制器械的外科子程序，由此系统根据外科子程序自动完成外科任务。
该方法的外科任务可以限定为包括在操作周期内根据外科子程序的超声功率水平曲线向端部执行器提供能量，以及下述步骤的一者或两者：在操作周期内根据外科子程序的纵向扫描曲线使超声端部执行器在横向扫描组织的处理区域；在操作周期内根据外科子程序的纵向扫描曲线使超声端部执行器在纵向扫描组织的处理区域。
在该方法中提供的超声外科系统可以还包括夹紧元件、超声刀片、具有力传输组件的启动单元，所述力传输组件可操作地与夹紧元件和控制单元连接，由此可以启动力传输组件，以操作夹紧元件，从而向保持在夹紧元件和刀片之间的组织施加可变夹持力。外科任务因此可以限定为包括在操作周期内根据外科子程序的夹持力曲线，操作夹持元件从而向保持在夹持元件和刀片之间的组织施加可变夹持力。
在该方法中提供的超声外科系统可以还包括具有超声刀片的端部执行器和具有刀片旋转组件的启动单元，所述刀片旋转组件可操作地与刀片和控制单元连接，由此可以启动刀片旋转组件，从而使刀片绕中心轴旋转。外科任务因此可以限定为包括在操作周期内根据外科子程序的刀片旋转曲线使刀片绕中心轴旋转。
在另一方面，用于超声处理外科患者的组织的方法可以包括提供根据图5描述的第二方面的超声外科系统，其中系统还包括具有至少一个传感器并具有相关的传感器电路的反馈系统，所述传感器位于至少一个超声和定位器械内，其中反馈系统可操作地与控制器械连接，在操作周期内与器械的操作性能参数相关的反馈信号可以从传感器传递至控制器械，以致控制系统可以处理反馈信号并根据外科子程序进行响应。所述方法可以还包括将外科子程序编入控制器械，用于完成多个外科任务，将器械的端部执行器定位在患者体腔内的手术部位内，初始化控制器械的外科子程序，从而系统自动进行外科任务，处理反馈信号并根据外科子程序对反馈信号进行响应。
尽管已经显示并描述了超声外科系统和方法的不同方面，应当理解本领域技术人员可以进行改进。本申请考虑并包括这种改进，并仅由后附权利要求的范围所限定。

Claims (17)

1.一种超声外科系统，包括：
超声单元，所述超声单元包括与超声发生器可操作地连接的器械，其中所述器械包括端部执行器；
包括可动臂的定位单元，其中所述可动臂适于保持所述超声单元的所述器械，用于将所述器械定位和定向在患者的手术部位；
控制单元，其与所述超声单元和所述定位单元通讯，所述控制单元可编有用于进行外科任务的外科子程序；以及
与所述控制单元通讯的用户界面，所述用户界面适于启动所述外科子程序的操作周期，从而在所述操作周期内自动进行所述外科任务，
其中，所述外科任务是通过在所述手术部位处操作所述端部执行器来进行的。
2.如权利要求1所述的超声外科系统，其中，所述可动臂可释放地保持所述器械。
3.如权利要求1所述的超声外科系统，其中，所述外科任务包括根据所述外科子程序的超声功率水平曲线向所述端部执行器提供能量。
4.如权利要求3所述的超声外科系统，其中，所述外科任务包括使所述端部执行器扫描身体组织。
5.如权利要求3所述的超声外科系统，其中，所述外科任务包括根据所述外科子程序的纵向扫描曲线使所述端部执行器在处理区域内沿纵向扫描。
6.如权利要求1所述的超声外科系统，其中，所述端部执行器包括夹紧元件和超声刀片中的至少一个。
7.如权利要求6所述的超声外科系统，还包括具有力传输组件的启动单元，所述力传输组件可操作地连接到所述夹紧元件上并与所述控制单元通讯，其中所述力传输组件适于启动所述夹紧元件并向身体组织施加可变的夹持力。
8.如权利要求1所述的超声外科系统，其中，所述端部执行器包括超声刀片。
9.如权利要求8所述的超声外科系统，还包括具有刀片旋转组件的启动单元，所述刀片旋转组件可操作地与所述超声刀片连接，从而可以启动刀片旋转组件，使刀片绕中心轴线旋转，其中所述外科任务包括根据所述外科子程序的刀片旋转曲线使所述超声刀片绕所述中心轴线旋转。
10.如权利要求9所述的超声外科系统，其中，所述超声刀片包括绕所述中心轴线布置并限定刀片横截面轮廓的多个刀片表面部分，其中所述超声刀片旋转，以使任何一个所述表面部分可以朝向组织定位。
11.如权利要求10所述的超声外科系统，其中，所述刀片表面部分包括平的表面部分、圆的表面部分、窄的表面部分和边缘表面部分中的至少一个。
12.如权利要求1所述的超声外科系统，其中，所述定位单元为外科机器人设备，其具有与所述可动臂通讯的工作台。
13.如权利要求7所述的超声外科系统，还包括反馈系统，所述反馈系统包括定位在所述超声单元、所述定位单元和所述启动单元中的至少一个内的至少一个传感器并具有相关联的传感器电路，其中所述反馈系统可操作地与所述控制单元连接，在所述操作周期内与所述器械的操作性能参数相关的反馈信号可以从所述传感器传递至所述控制单元，从而所述控制单元可以处理所述反馈信号并根据所述外科子程序进行响应。
14.如权利要求13所述的超声外科系统，其中，所述反馈系统包括电阻抗测量电路，用于测量被处理的组织的电阻抗。
15.如权利要求13所述的超声外科系统，其中，所述反馈系统包括声阻抗测量电路，用于测量被处理的组织的声阻抗。
16.如权利要求13所述的超声外科系统，其中，所述反馈系统包括温度传感器和温度电路，用于测量被处理的组织的温度、所述端部执行器的温度、靠近所述被处理的组织的物体的温度、以及围绕所述被处理的组织的流体温度中的至少一个。
17.一种超声外科系统，包括：
超声单元，其包括与超声发生器可操作地连接的器械，其中所述器械具有位于轴远端的超声端部执行器；
包括可动臂的定位单元，所述可动臂适于可释放地保持所述器械，从而操作者可以引导所述定位单元将所述端部执行器定位在患者体腔内的手术部位，从而进行多个外科任务；
可操作地与所述超声单元和定位单元连接的控制单元，其中所述控制单元编有用于进行所述外科任务的外科子程序；
与所述控制单元可操作地相连的用户界面，用于启动所述外科子程序的操作周期，从而在所述操作周期内自动进行所述外科任务；以及
反馈系统，其包括至少一个传感器并具有相关的传感器电路，所述至少一个传感器位于超声单元和定位单元中的至少一个内，其中所述反馈系统可操作地连接所述控制单元，在所述操作周期内与所述器械的操作性能参数相关的反馈信号可以从所述传感器传递至所述控制单元，从而所述控制单元可以处理反馈信号并根据所述外科子程序进行响应，
其中，所述外科任务是通过在所述手术部位处操作所述端部执行器来进行的。
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