CN102525644B - 具有触觉反馈的电外科封闭工具 - Google Patents
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
- A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
- A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter
Abstract
公开了一种具有触觉反馈的电外科封闭工具。一种外科工具系统,包括:用于封闭和横切组织的电外科工具,以及集成在所述工具的柄部上并至少以触觉效果的形式来向用户生成相关反馈的触知反馈系统。该触知反馈系统向用户警告组织性质,即位于工具钳口内部的组织何时被完全封闭,何时就绪切割组织,切割速率或速度,位于工具钳口内部的组织量,以及血管是否完全位于工具钳口以内。此外,触知反馈会向用户警告该过程中的能量施加的工作状态。
Description
技术领域
本文的实施例涉及用于治疗组织的外科工具,其中与组织治疗相关联的信息被处理,并以一种或多种集成在工具柄部上的反馈模式显示给用户。
背景技术
与外科医生在病人皮肤上切割相对较大的切口以触及内部器官的开放手术相反,微创手术过程是通过产生相对较小的切口以及随后通过该切口插入工具来触及这些器官的。通常,微创手术会使住院治疗时间变短,降低治疗需求,减小疼痛,减少伤痕,以及降低复杂度。
虽然涉及较小切口的微创手术过程包含了很多优于开放手术的益处,但是微创手术仍旧可能对外科医生提出挑战。例如,外科医生通常需要依靠经由切口引入的微型相机来查看病人内部器官,以及查看工具的移动及操作如何作用于器官。相机将图像传送到视觉显示器,以便允许外科医生查看内部器官和组织,以及查看其他微创工具对器官和组织的作用。由此,外科医生能够执行腹腔镜手术、剥离、烧灼、内窥镜检查、远程手术等等。
然而,与开放手术相比,微创手术在视觉和触觉感知方面呈现诸多限制,并且产生了只有这种手术才有的挑战。同时涉及开放手术和微创手术的一个关注焦点是组织有可能受到损伤,这种损伤有可能归因于不恰当的用力或是能量/热量的过度施加。例如,电外科工具是通过用高频电流刺激组织来工作的。电流的频率控制工具的行为,这些行为可以包括封闭/凝结和/或剥离。在开放手术和微创手术中,正待封闭的组织被夹在组织封闭工具的钳口内部,并且无法被用户看到,因此直接目视在确定何时达到电外科结束点,即,何时被夹组织完全封闭的过程中是没有帮助的。外科医生往往需要依靠经验和间接目视来确定组织何时被封闭、剥离,以及何时在组织中发生其他变化。基于上述内容,需要一种改进的微创外科工具,并且尤其需要一种具有与手术过程相关的改进的反馈的微创外科工具。
附图说明
通过以下在附图中示出的关于本发明实施例的描述,将会显见本发明的前述及其他特征和优点。在这里引入并构成说明书一部分的附图进一步用于解释本发明的原理,以及允许相关领域的技术人员制造和使用本发明。此外,这些附图并非按比例绘制的。
图1是示出了根据本文的一个实施例并且包括腹腔镜外科工具和外部控制系统的外科工具系统的侧视图的图示。
图1A是图1的腹腔镜外科工具的远端的放大视图。
图2是图1的外科工具系统的框图。
图3是根据本文的一个实施例而将与组织封闭循环相关的触觉效果传递给用户的外科工具系统的框图。
图4是根据本文的一个实施例而将与切割就绪相关的触觉效果传递给用户的外科工具系统的框图。
图5是根据本文的一个实施例而将与外科工具钳口内部的组织量或厚度相关的触觉效果传递给用户的外科工具系统的框图。
图6是根据本文的一个实施例而将与外科工具钳口内部的血管感测相关的触觉效果传递给用户的外科工具系统的框图。
图7是根据本文的一个实施例而将与能量应用状态相关的触觉效果传递给用户的外科工具系统的框图。
图8是示出了根据本文的一个实施例的具有触觉和音频反馈机制的外科工具系统的侧视图的图示。
图9是示出了根据本文的另一个实施例的具有触觉、音频和视觉反馈机制的外科工具系统的侧视图的图示。
具体实施方式
现在将参考附图来描述本发明的具体实施例,其中相似的参考数字指示相同或功能相似的部件。在以下描述中,术语“远侧”和“近侧”是相对于与执行治疗的临床医生的位置或方向来使用的。“远侧的”或“远侧地”指的是远离临床医生的位置或是处于离开临床医生的方向。“近侧的”和“近侧地”则指的是靠近临床医生的位置或是朝向临床医生的方向。
以下详细描述本质上只是说明性的,其目的并不是为了限制本发明或是本发明的应用和用途。此外,在先前的技术领域、背景技术、发明内容或是后续的详细描述中给出的任何明示或默示的理论都没有限制意义。
本发明的实施例涉及一种外科工具系统101,该系统包括:用于封闭和横切组织的腹腔镜外科工具100,用于向工具100提供电外科能量的控制系统112,以及整合在工具100中并且至少以触觉效果的形式来向用户产生相关反馈的触知反馈系统120。正如在本文将更详细解释的,反馈系统120提供的触知反馈会向工具用户告知组织性质,例如但不局限于位于工具100的钳口内部的组织何时已被完全封闭,何时就绪切割组织,切割速率或速度,位于工具100的钳口内部的组织的量,以及血管是否位于工具100的钳口内部。此外,如这里更详细说明的,反馈系统120提供的触知反馈可以向用户供应与工具100的工作状态相关的信息,例如但不局限于是否存在能量施加。
图1、1A和2示出的是包含了外科工具或设备100以及控制系统112的例示外科工具系统101的实施例。在一个实施例中,外科工具100是腹腔镜工具,它被配置成通过套针或其他微创进入口而插入。在另一个实施例(未显示)中,外科工具100是一个适于开放的医疗组织封闭过程的外科设备。外科工具100包括柄部102、杆部104以及具有钳口构件108、109的远侧部分106。钳口构件108、109分别包括相对表面108A、109A,这些相对表面被布置成彼此接近,并且夹紧或抓紧其间的组织。钳口构件108、109分别包括在其内形成的通道(在图1中并未显示),以便接收通过钳口构件108、109前进的可部署切割部件119。单纯出于例证目的,在图1中将切割部件119显示成了部分部署在开放的钳口构件108、109的内部。本领域普通技术人员将会了解,在操作过程中,只有在钳口构件108、109彼此接近并且夹住其内的组织时,切割部件119才会被推进/部署。杆部104被设计成将柄部102连接到远侧部分106,以及将柄部102的机械和电行为传递到远侧部分106。更具体地,柄部102的操作会通过从柄部102延伸到远侧部分106的内部机械连接器(未显示),以便打开和闭合钳口构件108、109。根据其中工具100是腹腔镜工具的图1实施例的一些示例,杆部104的长度可以是大约20cm到30cm,并且远侧部分106的长度可以是大约10mm到15mm。此外,杆部104的直径通常是5mm,但是通常也会使用直径为3mm、10mm和12mm的工具。通过操纵杆部102,操作者可以将远侧部分106插入病人腹部,并且控制钳口构件108、109。在一个实施例中,柄部102可以包括用于将钳口构件108、109旋入抓紧和夹住组织的位置的可旋转旋钮103。在将组织定位在钳口构件之间之后,钳口构件108、109将会彼此接近,以便将组织夹在其间,并且电外科能量将会借助控制系统112而被应用于封闭所述被夹住的组织。在被夹住的组织发生凝结之后,可以推进切割部件119来切割夹住的组织。在一个实施例中,柄部102可以包括用于推进切割构件119的可部署触发器121,以及借以应用电外科能量的可选通断开关123。例如,外科工具100可以是由Endo-Surgery,Inc开发的ENSEAL TRIO设备或是其他适合封闭和横切组织的腹腔镜工具。
更具体地,为了封闭夹住的组织,钳口构件108、109分别在表面108A、109A的一部分上包含了双极性电极110、111。在一个实施例中,电极110、111彼此偏离,以使得既便在组织很薄的情况下也不会接触。控制系统112向电极110、111提供电外科能量,以便封闭或凝结位于钳口构件108、109之间的组织。在一个实施例中,电极110、111是射频(RF)电极,控制系统112包括射频(RF)发生器,并且电极110、111将RF能量从控制系统112应用到组织。然而,本领域普通技术人员应该理解,控制系统112可以产生用于加热或切除组织的其他类型的能量,其中包括电能、超声波能量、冷冻消融能量等等,并且在每一种情况中,电极110、111都是应用该类型的能量的适当的相应组件。更进一步,在与替换类型的能量一起使用时,控制系统112可以监测适当的组织、系统和/或操作属性,以便指示治疗过程何时结束。
如所示,外科工具100是双极性工具,并且在控制系统112、电极110和111以及在电极110与111之间延伸的组织之间形成了完整的电路。然而,对本领域普通技术人员来说显见的是,外科工具100可以是包含了处于该工具的远侧部分的一个或多个电极以及位于病人体外的位置可调的参考电极(即皮肤贴片电极或接地板)的单极性工具。在单极性实施例中,电流和/或电压从控制系统112通过该工具远侧部分的电极流到病人外部的接地板或参考电极。如果多个电极位于该工具的远侧部分,那么相同的电流和/或电压将会流经每一个电极并进入病人体外的接地板或参考电极。
电极110、111分别经由两条导电引线113、115连接到控制系统112,其中所述引线是通过杆部的至少一个内腔(未显示)延伸的。电极110、111可以通过任何适当的手段固定附着于两个导电引线的远端。例如,这些电极可以借助焊接、焊锡、通过使用导电粘合剂、通过在其间添加连接部件或是通过别的机械方法来附着。虽然被显示成具有通过杆部104延伸的两条引线113、115,但是本领域普通技术人员应该理解,这两条引线仅仅是在工具100的远侧部分106整合双极性电极的工具所必需的。与此相反,在单极性工具中只需要一条引线通过杆部104延伸,以便将控制系统112连接到一个或多个电极,而外部引线或接地线则连接到病人外部的接地板或参考电极。
图2是进一步示出了外科工具系统101的主要组件之间的关系的外科工具系统101的框图。控制系统112提供电力以允许工具100执行组织封闭过程,并且与工具100的远端106以及工具100的柄部102进行通信以向用户提供触觉效果。更具体地,控制系统112包括电源114,用于接收来自工具100的一个或多个传感器140的测量值的处理器116(将在本文中更详细描述),以及被配置成将来自处理器116的传感器信息处理成触知反馈信号或命令的控制器或触知映射逻辑118。在一个实施例中,电源114、处理器116以及触知映射逻辑118合并成一个整体外部组件,该组件与外科工具100分离并且经由内部或外部导线电连接到电极110、111以及触觉反馈系统120。换句话说,控制系统112的所有组件全都可以处于同一外部设备单元内。然而在另一个实施例中,电源114、处理器116和/或触知映射逻辑118可以是电连接在一起的分离的外部组件。在再一个实施例中,电源114、处理器116以及触知映射逻辑118中的一个或多个可以安装在外科工具100的柄部102之内或其上,并且仅仅经由内部导线电连接到电极110、111以及触觉反馈系统120。
电源114产生具有足以封闭/凝结组织的适当功率水平和频率的交流电。在一个实施例中,电源116可以是由俄亥俄州Cincinnati,的Ethicon或是由马萨诸塞州Mansfield的Covidien制造的RF电源发生器,这两者都能提供最大输出介于50W-200W之间的高输出功率。例如,电源116可以产生用于凝结的大约处于450kHz的100W,虽然在该过程中,频率及其功率是可变的,从而虑及组织特异性等等。如上所述,引线113、115电连接电源114和RF电极110、111,以便为后者供应RF电力。
如将在本文更详细解释的,一个或多个传感器140可以根据期望的触觉效果而包括阻抗传感器、力传感器、位移传感器和/或压力传感器中的一种或多种。处理器116经由一条或多条引线或其他传输介质(未显示)电连接到传感器140。在工具的操作过程中,处理器116接收来自一个或多个传感器140的数据或测量值,并且根据需要来相应处理或分析传感器数据/测量值,以便向触知映射逻辑118提供正确类型的输入。处理器116可以包括逻辑资源,例如微处理器,并且还可以包括其他那些为分析和存储来自一个或多个传感器140的数据/测量值所必需的依赖于传感器的特定组件。
处理器116将源于工具100的一个或多个传感器的信息输出到触知映射逻辑118,所述逻辑则根据特定算法和操作者选择来进一步处理该信息。更具体地说,触知映射逻辑118被配置成将源于一个或多个工具传感器的感测到/计算得出的值映射到触知反馈信号或命令上。映射可以包括函数或查找表,或者可以包括更复杂的算法,如有需要也可以包括有限状态机。触知映射逻辑118确定响应于感测到/计算得到的值来产生什么样的触觉效果以及以何种顺序来产生这些效果。该触知映射逻辑118可以是通用或专用处理设备或微控制器。在一个实施例中,触知映射逻辑118可以与用于存储数据和/或指令的存储器设备(未显示)相关联。存储器设备可以是任何类型的存储设备或计算机可读介质,例如随机存取存储器(“RAM”)或只读存储器(“ROM”)。存储器设备存储的是由触知映射逻辑118执行的逻辑指令、命令和/或代码。该存储器设备还可以位于控制系统112内部或是内部与外部存储器的任何组合。在另一个实施例中,逻辑指令、命令和/或代码可以在硬件中实现,并且可以通过使用离散逻辑电路、专用集成电路(“ASIC”)、可编程门阵列(“PGA”)、现场可编程门阵列(“FPGA”)等等或是其任何组合而被并入触知映射逻辑118。在再一个实施例中,逻辑指令、命令和/或代码可以同时以触知映射逻辑118中的硬件以及存储器保存的软件/固件实现。虽然与处理器116是分开描述的,但是本领域普通技术人员应该理解,这种功能描述只是说明性的,并且同一个设备是可以作为处理器116和触知映射逻辑118使用的。
触知映射逻辑118向耦合到工具100的柄部102的触觉反馈系统120输出控制信号,以便在执行过程时向操作者提供反馈信息。所述控制信号则是经由将触知映射逻辑118电连接到触觉反馈系统120的第三引线或系绳117(参见图1)来传递的。此外,在控制系统112与柄部102之间还有可能提供第四引线(未显示),以便为在本文将更详细描述的处于柄部102内部的低电压执行器电路提供隔离接地线。
触觉反馈系统120包括至少一个执行器驱动电路122(如图2所示),该电路耦合到触觉执行器124(如图2所示),以便向操作者提供触觉反馈。为了向操作者提供触觉反馈,触觉反馈系统120电连接到控制系统112。在一个实施例中,为了将命令从触知映射逻辑118传递到触觉执行器124,控制系统112沿着引线或系绳117向工具100的柄部102提供马达电压。如在本文将更详细解释的,触觉执行器124可以包括但不局限于一个或多个振动触知或者动觉执行器,这些执行器使用任何适当仪器化来提供期望的触觉效果,所使用的仪器例如但不局限于与工具100耦合的摩擦制动器或是动态马达。由此,触知映射逻辑118将控制信号输出到包含了用于为触觉执行器124供应所需电流和电压的电子组件和电路的驱动电路122,以便产生期望的触觉效果。如上所述,还可在控制系统112与手柄102之间提供第四引线(未显示),以便为柄部102中的驱动电路122提供隔离接地线,由此触知映射逻辑118经由具有两条导线的隔离DC电压线路来与触觉反馈系统120进行通信。
触觉反馈可被产生并提供给用户,这其中包括振动触知,动觉,手柄变形和/或其他类型的触知反馈,例如纹理和热度。触觉执行器124可以包括电磁马达、通过马达来移动偏心质量的偏心旋转质量(“ERM”)执行器、附着于弹簧的质量被来回驱动的线性共振执行器(“LRA”)、记形合金、响应于信号而变形的电活性聚合物、用于改变刚性的机构、振动触知执行器、惯量执行器、压电致动器或其他适当类型的执行设备。在一个实施例中,触觉执行器124可以作为惯量执行器来实现,以便向操作者提供振动触知反馈。在另一个实施例中,举例来说,动觉触觉反馈可以使用改变柄部102的刚度/阻尼的螺线管,改变柄部102大小的小型空气袋,或是形变材料。关于适合在这里使用的驱动电路和触觉执行器的详细描述可以在2007年9月28日提交的美国专利申请11/862,639(律师案卷号IMM274)中找到,其中该申请在这里全部引入作为参考。
在一个实施例中,触觉执行器124是在柄部102产生用于触觉反馈的振动的振动触知设备。例如,在一个实施例中,可以将一个或多个振动触知执行器并入柄部102内与外科医生手部的手指和大拇指相对应的若干个位置,以便在整个柄部提供高带宽振动触知反馈。如果在谐振时具有介于4-5G的目标加速度,以及具有100-250Hz且大于2.5G的响应,那么将会是非常理想的。在一个实施例中,所有与触觉执行器124的执行相关的移动质量成分全都处于工具100内部。
在另一个实施例中,触觉执行器124是诸如摩擦制动器或启用可变电阻的马达之类的用于触觉反馈的动觉设备,以便在柄部102上移动、锁定和制动显示。例如,在一个实施例中,用于切割部件118的触发器121可以配备有动觉执行装置,以便能够实现动觉触觉效果。此外,可以将一个或多个动觉执行器并入柄部102内与外科医生手部的手指和大拇指相对应的若干个位置处,以便在柄部的整个握紧部分提供运动阻力。动觉执行器至少必须能够明显阻碍运动。例如,在一个实施例中,动觉执行器可以具有介于最大作用力20%与30%之间的阻力,以便显示有效的障碍力度。在另一个实施例中,动觉执行器能够阻止所有的用户运动,以便传递“封锁”模式。
如先前所述,一个或多个工具传感器的类型以及处理器116的操作取决于期望的触觉效果。在一个实施例中,传感器是阻抗传感器并且处理器持续测量夹在工具100的钳口108、109之间的组织的阻抗,以便提供组织封闭循环或治疗何时结束的指示。特别地,电外科能量目的是封闭处于治疗位置的细胞,同时保持组织的基本结构完好无损。由于用户不应该在充分封闭之前切割组织,因此,用户有必要知道封闭循环何时结束。虽然某些封闭工具包括在被假设成是封闭循环结尾的预定时间量结束时的预定音频警报(即,十五秒),但是该音频警报很容易与其他音频警报相混淆,并且在嘈杂的手术室环境中未必会被听到。此外,单独使用时间并不能很好地指示封闭质量。实时阻抗测量则可允许用户估计凝结治疗的完成状态,即组织封闭程度。已封闭的组织将会阻碍电信号,这一点可以通过同时监测组织的阻抗而被精确指示。相应的,通过监测阻抗,可以指示封闭处理何时完成,以及何时可以向工具的柄部提供触觉效果,以便警告用户封闭循环已经完成。
更具体地,如图3所示,外科工具300包括一对能够测量组织阻抗的辅助电极340A和340B,并且控制系统包括封闭循环处理器316。电极340A、340B可以分别位于钳口构件108、109上的相邻电极110、111的相对表面108A、109A。电极340A经由引线(未显示)电连接到电源114,并且电极340B经由引线(未显示)电连接到封闭循环处理器316。电源114和封闭循环处理器316通过一起工作来连续实时地测量目标组织阻抗。电源114能够产生范围在1kHz到500kHz或是为生物阻抗测定领域中的技术人员所知的其他适当频率的无害交流电,以便允许测量阻抗。例如,所使用的可以是处于50KHz且大小为2微安的电流。在电流流动时,封闭循环处理器316将会测量电极340A、340B之间的相应电阻。然后,封闭循环处理器316用算术方法将电阻转换成阻抗测量值。为了测量阻抗,封闭循环处理器316可以包括逻辑资源,例如微处理器、电压电流转换电路、放大电路、A/D转换电路以及阻抗算术运算部分。为了确定适当的组织封闭,封闭循环处理器316可以记录和/或计算不同的参数,这其中包括电流、电压、功率、阻抗以及这些参数的变化率。虽然在这里是作为经由一对辅助电极340A、340B来测量阻抗而描述的,但是本领域普通技术人员将会理解,工具100的配置可被调整成交替地在电极110、111之间监测阻抗,由此消除对于辅助电极对的需要。
当阻抗或是其他被测量/计算的一个或多个系统参数表明组织封闭完成时,触知反馈系统120会向用户提供触觉效果。组织封闭循环的完成必须指示给用户,以便允许用户继续进行手术。在一个实施例中,触觉效果可以是表明组织封闭循环完成的单个触觉警报,例如振动触知警告。在另一个实施例中,在组织阻抗接近于组织封闭循环结束时,触觉效果可以包括基于现场阻抗值的连续反馈,例如在柄部102的触发器121上具有一系列递增振幅的振动触知反馈和/或动觉障碍或抗力。本领域普通技术人员应该理解,触觉效果可以包括警报以及连续反馈两者,并且可以包括振动触知和动觉效果两者。
对处于治疗部位或其附近的阻抗进行监测以及确定治疗完成度的处理可以依照任何判据来确定。例如,适当的组织封闭可以借助于检测电阻抗的具体值(即,假设组织在阻抗达到450欧的时候封闭)或是借助于检测在期望时段或是规定数量的连续阻抗测量值上相对恒定的一系列阻抗测量值来确定。在一个实施例中,完成的组织封闭可以与10欧的阻抗变化相关联。通过使用查找或功能表,可以将感测到/计算得到的阻抗值映射到触知反馈信号或命令上,以便在组织封闭时向外科医生提供逐渐增大的反馈。其他查找功能同样是可行的,并且是可供用户选择的。在另一个实施例中,完成的组织封闭可以是不同观察参量的函数,例如阻抗、阻抗变化、电流、电压、功率等等,或者可以是从组织模型的输出映射而来的。
在一个实施例中,为了封闭组织而施加的能量将会持续预定时段,其中该预定时段被假设成是封闭循环的结束。例如,能量可以在大小为15秒的封闭循环中施加。如果阻抗信息并未指示完成封闭,那么可以在该预定时段结束时提供一个负价的振动触知警报,而如果阻抗信息表明完成封闭,则可以在该预定时段结束时提供一个正价的振动触知警报。相应地,用户可以在决定是否需要将附加封闭循环应用于目标部位来完全封闭组织时使用触觉警报。
在再一个实施例中,触觉映射逻辑118可以向电源114输出命令信号。例如,当组织的阻抗表明完成组织封闭时,触觉映射逻辑118可以输出一个命令信号来关闭电源114,由此防止向组织传递附加能量以及控制工具100的行为。
在图4所示的另一个实施例中,阻抗测量值可被用于提供与切割就绪状态和/或速率相关的反馈。腹腔镜封闭工具可以依靠操作者来控制切割部件在封闭处理过程中的推进。除了执行剥离之外,由于刀刃的推进将会控制施加于夹在工具钳口之间的组织上的压力,因此,切割部件119还在该过程的封闭处理部分起着重要的作用。在实现完全封闭的过程中,特别是对较厚的组织和/或血管而言,足够的压力是至关重要的。因此,用户经常希望推进切割部件至紧邻组织的位置,以便达到用于封闭组织的最大压力,而且还希望暂缓推进切割部件至组织中,直至其被充分封闭。切割就绪状态处理器416执行阻抗或其他电参数计算,这些计算可以用于向用户提供与进行切割的组织就绪以及切割的恰当速率或速度有关的指导。为了确保充分组织封闭,限制或控制切割部件的推进是非常重要的,由此,关于恰当的切割速度的反馈是有用的。如图4所示,在该实施例中,工具400包括:一对用于监测阻抗的辅助电极340A和340B,能够测量切割部件119的位移的位移传感器440,以及切割就绪状态处理器416。位移传感器440与切割部件119耦合,以便提供关于切割部件119的位置的信息,并且电极340A、340B以及位移传感器440全都经由一条或多条引线(未显示)电连接到切割-就绪状态处理器416。钳口位移可由位于钳口构件铰链上的电位器或其他适当的位置编码器来测量的。位移传感器440持续监测切割部件119的位置,以便向处理器416提供与切割部件119何时紧邻该组织而使其进一步推进会导致组织切割相关的信息,即,切割部件119何时处于切割位置的信息。切割就绪状态处理器416还持续接收来自电极340A、340B的阻抗测量值,并且如上文中对照处理器316描述的来计算阻抗。
基于来自传感器440的位移测量值以及来自电极340A、340B的阻抗测量值,可以将切割就绪状态和/或切割速度反馈提供给用户。切割反馈可以用不同的模式提供,例如训练模式和经验模式,由此适应对工具具有不同经验程度的用户的需要。在训练模式中,触觉效果可以包括基于现场阻抗值在柄部102的触发器121上的连续主动阻力反馈,以便防止过早和/或过快的切割。例如,在来自位移传感器440的测量值表明切割部件119处于切割位置时,在阻抗值小于100欧姆的过程中将会提供最大阻力,并且在会为大于450欧姆的阻抗值提供零阻力。在阻抗值介于100与450欧姆的过程中,触发器121上的阻力会以一种连续或步进的方式从最大值逐渐降低至零。在经验模式中,如果来自位移传感器440的测量值表明切割部件119处于切割位置,并且阻抗小于450欧姆,那么在该行程(stroke)的切割部分开始时,触觉效果可以包括在柄部102的触发器121上进行的相对较小的制动。此外,经验模式可以包括具有用于100与450欧姆之间的阻抗值的一系列振幅递增且连续的振动触知反馈。在另一个实施例中,制动振幅是组织阻抗的函数,由此,当组织处于低阻抗状态时,呈现出粗糙纹理或阻碍序列,并且它们其会随着组织阻抗的增大而逐渐减小。该反馈可以采用时间连续的方式显现,或者只在切割部件运动期间显现。
除了与切割就绪状态和/或切割速率相关的触觉效果之外,在切割过程中还可以提供与被切割的组织类型相关的触觉反馈。例如,在触发器121和/或柄部102上与外科医生手部的手指或大拇指相对应的若干个位置可以提供被动的动觉阻力。在切割部件119的运动过程中,动觉阻力可以是感测到的组织性质的函数。例如,动觉阻力可以依照被切割组织的硬度改变,其中所述硬度可以借助处于工具远侧尖端的应变仪或是其他适当传感器感测。关于监测硬度之类的组织性质的处理以及提供与之相关的触觉效果的处理的更详细描述可以在2007年12月13日提交的美国专利申请11/955,563(律师案卷号IMM273)中找到,其中该申请在这里全部引入作为参考。
在图5中示出的另一个实施例中,触知反馈系统120向工具用户告知位于工具100钳口内部的组织的量,以便告知用户是否封闭了过多组织。封闭工具通常是为最大组织和/或血管厚度设定的,并且应当在夹在钳口构件108、109内部的组织量超出该限度的情况下向用户发出警报。此外,钳口中的组织量还会影响封闭质量。工具500至少包括耦合至工具500的柄部102的力传感器540A,以及处于控制系统中的组织量处理器516。所述力传感器可以是能够测量用户为了封闭工具500的抓紧器柄部所施加的力的任何类型的力传感器,例如箔式应变计、压力应变仪、力感测电阻器、压力传感器或其他适当的传感器。可以用于力传感器540A的例示产品包括Tekscan力传感电阻器以及Omega箔式应变计。工具500还可以包括耦合至工具远端以监测钳口构件之间间隔的位移传感器540B。钳口位移可以借助位于钳口构件铰链或工具杆部的电位器或其他适当的位置编码器来测量。由于钳口部件接近闭合时的高位力信号没有钳口构件刚开始关闭时的高位力信号那么显著,因此可以使用位移传感器540B来补充来自力传感器540A的信号。由此,在一个实施例中,力传感器540A和位移传感器540B将会结合使用,以便确定何时会有超量的组织位于钳口构件以内。组织量处理器516持续监测从力传感器540A和位移传感器540B接收的力的测量值(如果有的话),并且从所述力的测量值中计算/估计位于工具500的钳口内部的组织的量。在一个实施例中,关于组织厚度的最佳指示符乃至由组织量处理器516监测的参数是与钳口间隙位移相对的力的变化率。此外,在一个实施例中,用户可以将力的状态(即高、中、低)输入图形用户界面,以使得处理器516执行的计算与被所述工具抓紧的组织的等级/类型是相符的。
基于来自传感器540的力的测量值,可以向用户提供组织量/厚度反馈。触觉反馈将会通过若干阈值作为力测量值而被提供给用户。例如,为了警告用户在钳口中有可能存在过多的组织,该反馈可以包括通过阈值作为力测量值且振幅递增的振动触知警报,和/或柄部102的抓紧器上的通过阈值作为力测量值且幅度递增的动觉反馈。在另一个实施例中,如果设备内部的组织量超出设备规定范围,那么可以给出负价的振动触知警报,如果处于设备内部的组织量处于设备规定范围以内,则可以给出正价振动触知警报。此外、触觉反馈可以采用不同模式提供,例如训练模式和经验模式,以便适应那些对工具具有不同经验程度的用户的需要。在训练或初学者模式中,当所述力超出当前最大值(即4500mNm)时,触觉效果可以包括用于防止切割组织的动觉锁定触发器121,和/或用于防止用户夹紧组织的柄部102的抓紧器。此外,脉冲发生的振动触知警报或错误可被传递给用户。在经验模式中,当所述力超出当前最大力(即4500mNm)时,如果用户开始切割,那么触觉效果可以包括负价振动触知警报和/或触发器121上的高幅动觉障碍。
在再一个实施例中,触知反馈系统120向工具用户告知外科工具钳口内部的血管组织的定向。如果血管结构超出钳口内部的阈值直径,那么将会向用户发出通知,并且更重要的是,如果血管组织尚未完全处于钳口内部或者没有在钳口中被良好定向时,那么将会向用户发出通知。工具600包括与工具远端106耦合的一个或多个压力传感器640A和一个或多个位移传感器640B,以及处于控制系统内部的血管感测处理器616。钳口位移可以借助位于钳口构件铰链上的电位器或是其他适当的位置编码器来被测量。压力感测是用诸如通过压力分布系统产生的电容性压力传感器阵列而被最有效地实现的。在一个实施例中,微传感器阵列耦合至工具远端106,以便感测钳口构件的压力和位移。血管感测处理器616持续监测分别从传感器640A、640B接收的压力和位移测量值,并且通过解释压力/脉动数据来确定血管是否延伸并超出设备的远侧尖端。对于使用适合在这里使用的微创工具来检测血管的可能适合的传感器和方法来说,与之相关的详细描述可以在以下专利申请中找到:2009年1月15日提交的美国专利公开2010/0179423;2008年12月3日提交的美国专利公开2010/0137845;2008年12月12日提交的美国专利公开2010/0152586;2009年1月15日提交的美国专利公开2010/0179587,其中每一份专利公开都在这里引入作为参考。用于血管感测的触觉反馈可以同时包括振动触知和动觉效果。例如,为了警告用户血管仅仅部分处于工具600的内部,触觉效果可以包括用于防止切割组织的动觉锁定触发器121,和/或用于防止用户夹紧组织或是啮合切割构件的柄部102的抓紧器。此外,脉冲发生的振动触知警报或错误也可被传递给用户。
在另一个实施例中,压力传感器640A、位移传感器640B和血管感测处理器616还可以用于警告工具用户封闭处理是否成功封闭了位于外科工具钳口内部的组织。由于用户在充分封闭之前不应该将夹住的组织从外科工具的钳口中释放,因此,用户必须知道组织是否已通过电外科处理封闭。通过检测充分封闭,可以防止灾难性出血,这种情况有可能会在没有夹住足够多的需封闭血管的情况下发生。更具体地,在释放夹住的组织之前,血管感测处理器616可以使用来自一个或多个压力传感器640A以及一个或多个位移传感器640B的测量值信号来确定所述封闭两侧是否仍旧存在血管脉动,即,显著内腔(patent lumen)。如果在完成电外科处理之后组织被封闭,那么不会有血流/脉动通过血管。用于封闭完成度的触觉反馈可以同时包括振动触知和动觉效果。例如,为了警告用户组织尚未完全封闭,触觉效果可以包括触发器121上防止切割组织的动觉封锁或高幅障碍。在另一个实施例中,如果组织尚未完全封闭,那么可以给出负价的振动触知警报。
触觉反馈可以为用户提供帮助的另一领域包括控制系统112和/或工具100的不同工作状况。在图7所示的外科工具700的另一个实施例中,触知反馈系统120向用户提供与电源114的工作状态相关的信息,即,指示何时通过该工具来施加电外科能量。当在封闭工具上激活电外科能量时,需要与这里描述的封闭工具一起使用的发生器来提供至少一个音频警报。然而在嘈杂的手术室环境中,音频指示未必会被清楚传达给用户。在这个实施例中,用于施加电外科能量的开关123将被仪器化,以便允许能量状态处理器716监测其工作状态。当启用能量并且开关123处于“接通”位置时,用户将会感受到触觉效果,例如细微的变压器类型的震动杂声或感觉,以便指示在工具700中存在能量流。此外,在启用能量时,用户可以感觉到动觉机械制动.如果在切割过程中能量停止,那么可以向用户传递脉冲发生的振动触知警报或错误。此外,振动触知警报可以与发生器提供的音频警报一起使用,并且在趋近和/或达到诸如15秒的预定时间量时,可以使用具有更高振幅和频率的不同的振动触知警报。该预定时间量可以对应于完成组织封闭处理所需要的平均或估计时间。
上述实施例涉及的是可被监测并以触觉效果形式传达给用户的不同状况。虽然用于阻抗监测、切割就绪状态、组织量、血管感测和能量状态的触觉效果在这里是各自分开描述的,但是本领域普通技术人员应该理解,外科封闭工具可以引入上述实施例的任何组合。特别地,触觉反馈可以包括采用了空间触觉纹理或组合的动觉振动触知刺激的形式的信号组合。此外,包括一个或多个上述实施例的外科封闭工具的单个处理器可以被配置成接收来自不同传感器设备的输入/测量值,以及对其执行所需要的任务或计算。
如这里所述,脉冲发生的振动触知警报或错误可以在不同的状况中使用,以指示工具100的不恰当使用。该振动触知错误警报可以用于确保符合关于使用工具100的所有恰当指令,这其中包括这里描述的感测到的不恰当使用,或是其他可编程的不恰当使用,例如时段或步骤顺序。在一个实施例中,振动触知误差触觉效果可以对于所有的错误状态是相同的,但是也可以包括改进的触觉、听觉或视觉效果,这些效果会向用户提供关于特定错误状态的信息。这些改进的效果可以包括具有用户可辨认包络的附加触觉脉冲,以便指示不同的状况。作为替换,差错效果可以取决于状况的严重性采用不同的时间间隔显现。在另一个实施例中,正价或负价警报可以是在发生了警报状况之后的固定持续时间中执行的,在一些情况中,当手术刀返回其静止位置时,它有可能会继续该时间。
举个例子,参考图8,该图显示的是为操作者引入了两种反馈类型或模式的实施例。特别地,触觉反馈系统820同时经由触觉执行器124和音频设备或扬声器826提供触觉和音频反馈。根据启用这些反馈机制中的哪一个以及如何对其进行控制来提供其各自的输出,触知映射逻辑118将经过处理的信息传递到触觉执行器124和音频设备826中的一个或多个。在一个实施例中,反馈可以是在操作者执行手术时被连续提供给操作者的。在另一个实施例中,反馈可以是在满足特定状况而向操作者发出警报以进行通知或警告时提供给操作者的。更进一步,一种反馈(即,触觉或音频)可以是连续提供的,而另一种反馈则是作为警报提供的。此外,触觉反馈警报可以是递增的连续触觉反馈。在一个实施例中,无害的听觉反馈可以用于指示正常操作,触知/触觉反馈则可被用作警报或警告,以向用户指示何时存在特定状况或状态,并且听觉和/或视觉反馈(例如蜂鸣声和闪光)可以用作警报来向用户指示何时存在严重的状况或状态。
参考图9,该图显示的是为操作者引入了三种反馈类型或模式的实施例。特别地,触觉反馈系统920分别借助触觉执行器124、音频设备或者扬声器826、以及视觉显示器928提供触觉、音频和视觉反馈。根据启用了这些反馈机制中的哪一个以及如何对其进行控制来提供其各自的输出,触知映射逻辑118将经过处理的信息传递到触觉执行器124,音频设备826、视觉显示器928中的一个或多个。在这个实施例中,视觉显示器928是处于柄部102背部区域上的液晶显示器(LCD)屏幕。在另一个实施例中,视觉显示器928可以并入腹腔镜的摄像监测器显示器,以使视觉反馈始终处于用户的视线以内。视觉显示器928可被用于显示RF电源114的阻抗信息和/或工作状态。在一个实施例中,超声换能器(未显示)可以耦合到工具100的远侧部分106,并且视觉显示器928可以被配置成显示超声图像信息,以便帮助外科医生根据需要来定位工具。视觉显示器928可以包括触摸屏,它可以被配置成向操作者呈现信息,并且还可以被配置成感测操作者何时按下触摸屏的特定部分。这样一来,触摸屏可以充当具有图形表示能力的可触摸用户界面。视觉显示器928可以包括图形用户设备,该设备允许外科医生选择不同的反馈简档,调节传感器行为,修改补充信息等等。
根据图9的实施例,外科工具900的柄部902还可以包括一个或多个按钮932。按钮932可以被配置成使用任何适当的机制来允许操作者控制提供给所述操作者的反馈的特性。按钮932可以包括允许调节某些等级、强度或幅度或是允许对向操作者呈现的输出进行某些选择的设备。在一些实施例中,按钮932可以被配置成开关,例如瞬时拨动开关,由此允许操作者选择将传感器信息映射或提供至各输出设备的不同方式。按钮932可以作为摇臂开关或是作为一维控制表面而实现。根据按钮932的一种功能,通过控制是否基于感测信号来将输出信号提供给各输出设备,操作者可以启用或禁用一个或多个输出机构。按钮932的另一种功能包括启用一个或多个输出机构的能力。关于这一点,操作者可以控制是否以及如何以视觉、听觉和/或触觉方式来呈现反馈。如果反馈适合的是外科医生的偏好,那么该工具可以提供反馈来补充操作者的经验,以便实现更好的操作和性能。
本领域普通技术人员将会显见的是,本文的实施例涉及的是可以由操作者操作的任何类型的工具。更具体地,在本公开中描述的工具包括以机械方式控制工具远侧部分的柄部。根据本文的一个实施例,位于外科工具上的一个或多个传感器以及触觉反馈系统可以一起发挥作用,以便提取与工具的工作状态相关的相关信息,所述信息随后将会作为触觉、音频和/或视觉反馈传递给操作者。虽然所公开的实施例是用于腹腔镜手术的,但是其他实施例可以用于非腹腔镜手术,例如用在脉管或其他的导管插入术中,其中从工具尖端的传感器检测到的信息可以被回传到导管柄部。更进一步,对于内窥镜检查过程来说,从柔性内窥镜上的传感器检测到的信息可以被回传到内窥镜柄部。举例来说,其他实施例也可用于远距手术或远程呈现,以便执行例行的外部检查和/或由远程医生使用开放外科工具。另一个实施例是将这类反馈包括在机器人外科系统中,例如Intuitive Surgical,Inc的da外科系统,以使操作者能够具有直接的触知反馈。
虽然在上文中根据本发明已经描述了不同实施例,但是应该理解,这些实施例仅仅是作为例证和示例而不是作为限制给出的。相关领域的技术人员将会显见的是,可在其中进行各种形式和细节方面的变化而不脱离本发明的精神和范围。由此,本发明的广度和范围不应该受上述任一例示实施例的限制,而应该仅根据所附权利要求及其等效方案限定。此外还应该理解,在这里论述以及在这里引用的每一个实施例的每一个特征都可以与其他任何实施例的特征结合使用。这里论述的所有专利和公开都被全文引入以作为参考。
Claims (9)
1.一种外科工具系统,包括:
被配置成封闭组织的电外科工具,该工具包括远侧部分,该远侧部分包括经由杆部与柄部相连的组织封闭机构;
与所述电外科工具耦合的传感器,其中该传感器被配置成监测组织性质;
与传感器电连接的控制系统,其中该控制系统从接收自传感器的信号计算传感器信息,并且将传感器信息处理成信号命令;
包括一个或多个触觉执行器的与柄部耦合且与控制系统电连接的反馈系统,其中所述控制系统将信号命令传递到反馈系统,并且反馈系统使用信号命令来向柄部产生与传感器信息相关的触觉反馈;
处于工具的远侧部分的可部署切割部件以及与切割部件耦合的位移传感器,其中反馈系统产生的触觉反馈还向用户告知通过切割部件来切割组织是否就绪或是切割部件的切割速度;以及
与可部署的切割部件耦合的触发器,其中一个或多个触觉执行器包括与触发器耦合的动觉执行器,以使得能够向运动施加可变阻力作为触觉反馈。
2.根据权利要求1所述的外科工具系统,其中传感器被配置成监测电组织性质,并且反馈系统产生的触觉反馈向用户告知组织已被完全封闭。
3.根据权利要求2所述的外科工具系统,其中传感器是与电外科工具的远侧部分耦合的阻抗传感器。
4.根据权利要求1所述的外科工具系统,其中传感器包括:与柄部耦合的第一力传感器,以及与耦合至工具的远侧部分的两个相对的钳口构件相耦合的第二位移传感器,并且反馈系统产生的触觉反馈向用户告知位于与工具的远侧部分相耦合的两个相对钳口构件内的组织的厚度。
5.根据权利要求1所述的外科工具系统,其中组织是血管,并且其中传感器耦合到工具的远侧部分,并且从压力传感器和位移传感器中选出,以及反馈系统产生的触觉反馈向用户告知血管仅仅部分位于与工具的远侧部分耦合的两个相对钳口构件内。
6.根据权利要求1所述的外科工具系统,其中反馈系统被配置成产生还向用户告知与电外科工具电耦合的电源的工作状态的触觉反馈。
7.根据权利要求1所述的外科工具系统,其中反馈系统被配置成产生至少包括振动或动觉反馈的触觉反馈。
8.根据权利要求1所述的外科工具系统,其中传感器耦合至工具的远侧部分,并且是从压力传感器和位移传感器中选出的,以及其中反馈系统被配置成产生通过检测到不存在通过血管的脉搏来向用户告知组织已被完全封闭的触觉反馈。
9.根据权利要求1所述的外科工具系统,其中用于产生触觉反馈的信号命令取决于用户的经验等级。
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US12/962,462 US8801710B2 (en) | 2010-12-07 | 2010-12-07 | Electrosurgical sealing tool having haptic feedback |
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JP2012120841A (ja) | 2012-06-28 |
US8801710B2 (en) | 2014-08-12 |
JP6133535B2 (ja) | 2017-05-24 |
EP2489317A1 (en) | 2012-08-22 |
US20120143182A1 (en) | 2012-06-07 |
EP2489317B1 (en) | 2016-03-30 |
EP2489317B2 (en) | 2019-07-31 |
CN102525644A (zh) | 2012-07-04 |
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