CN102525582B - 具有触觉反馈的手术缝合器 - Google Patents

具有触觉反馈的手术缝合器 Download PDF

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CN102525582B
CN102525582B CN201110404104.5A CN201110404104A CN102525582B CN 102525582 B CN102525582 B CN 102525582B CN 201110404104 A CN201110404104 A CN 201110404104A CN 102525582 B CN102525582 B CN 102525582B
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C·乌尔里希
A·莫达里斯
P·格雷戈里奥
C·西梅克
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    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
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Abstract

公开了一种具有触觉反馈的手术缝合器。一种外科工具***，包括：用于用于切割和缝合组织的外科工具，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***。该触知反馈***向用户警告组织性质，即，位于工具钳口内部的组织或其他结构的类型，位于缝合器钳口内部的组织的量或厚度是否适合所选择的缝合钉钉盒，是否已基于位于钳口内的组织长度击发了合适的缝合器长度，血管是否位于缝合器的钳口内部，缝合过程是否已成功封闭位于缝合器钳口内部的组织，和/或何时完成缝合过程或击发循环。

Description

具有触觉反馈的手术缝合器
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***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，这种损伤有可能是因为不恰当地用力造成的。例如，手术缝合器包括一个同时在组织中产生纵向切口并且在切口相对两侧上施加缝合线的远端，该手术缝合器的远端包括用于夹紧或抓住组织的钳口，并且用户依照设备而使用单次击发冲程(firing stroke)或多次击发冲程来击发手术缝合器。在开放手术和微创手术中，被缝合的组织是夹在手术缝合器的钳口内部的，并且是不能被用户看到的，由此，直接目视对外科手术过程相关的特定组织性质是没有帮助的。击发手术缝合器使得被夹住的组织割断并缝合。在马达驱动的手术缝合器中，切割/缝合操作仅仅是通过按下按钮或是击发触发器来致动的。但是，用户更愿意保持控制缝合器的部署，并且愿意具有在设备柄部感受到的力过大的情况下或是因为其他某些临床原因而在任何时间停止部署的能力。相应地，需要改进的手术缝合器，尤其需要具有与外科手术过程相关联的改进反馈的马达驱动的手术缝合器。
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***的外科工具***的侧视图的图示。
图2是图1远端的放大透视图。
图3和图4示出了图1的外科工具的操作的图示，其中图3示出的是如何将组织夹在外科工具远端内部，以及图4示出的是如何将缝合器击发到夹住的组织中。
图5是图1的外科工具***的框图。
图6是根据本文的一个实施例而将与组织各向异性相关的触觉效果传递给用户的外科工具***的框图。
图7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以及对缝合钉钉盒(staple cartridge)选择的确认相关的触觉效果传递给用户的外科工具***的框图。
图8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***的框图。
图9是根据本文的一个实施例而将与切割部件状态相关的触觉效果传递给用户的外科工具***的框图。
图10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***的侧视图的图示。
图11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***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***101，该***包括：用于切割和缝合组织的腹腔镜缝合器100，用于处理来自工具100的传感器信息的控制***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***120。正如在本文将更详细解释的，反馈***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缝合器钳口内部的组织或其他结构的类型(即，组织的各向异性)，位于缝合器钳口内部的组织的厚度是否适合所选择的缝合钉钉盒，位于缝合器钳口内部的组织的长度是否适合所选择的缝合钉钉盒，血管是否位于缝合器的钳口内部，切割部件的位置，和/或何时完成缝合过程或击发循环。
图1-5示出的是包含了外科工具或缝合器100以及控制***112的例示外科工具***101的实施例。参考图1和2，在一个实施例中，缝合器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***。在另一个实施例(未显示)中，缝合器100是一个适于开放的医疗组织封闭过程的外科工具。缝合器100包括手柄部分102、杆部104以及具有(将被更详细解释的)用于夹持和缝合其间的组织的钳口构件108、109的远侧部分106。如图2最佳的显示，钳口构件108形成了一个具有可释放地接收缝合钉钉盒110的大小的细长通道，其中在所述缝合钉钉盒中具有至少两行横向间隔的缝合钉(未显示)，并且钳口构件109定义了一个可枢轴转移的夹钳构件或是具有与钉盒中的缝合钉行相对齐的缝合钉形成袋(未显示)的砧部。工具100还包括可以在钳口构件108、109内部纵向推进，以便切割或横切被夹住的组织的切割部件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闭合在一起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被设计成将手柄部分102连接到远侧部分106，以及将手柄部分102的机械行为传递到远侧部分106。例如，手柄部分102的操作会通过从手柄部分102延伸到远侧部分106的内部机械连接器(未显示)，以便打开和封闭钳口构件108、109。根据其中缝合器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6cm到8cm之间。此外，杆部104的直径通常是10或12mm，但是有时也会使用直径为3mm和5mm的工具。
手柄部分102包括把手105，闭合触发器123以及击发触发器121。在一个实施例中，手柄部分102可以还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选择旋钮103。在操作中，闭合触发器121首先会被致动。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。通过如图3所示将闭合触发器121向后拉到与把手105直接相邻的位置，钳口构件或砧部109将会接近于钳口构件108，以便夹住位于钳口构件108内部的砧部与缝合钉钉盒110之间的组织。在缝合钉钉盒110上可以安置一个锁销(未显示)，以便在砧部闭合进入组织夹持位置时由砧部啮合。在组织夹持发生之后，通过如图4显示的那样朝着把手105移动击发触发器121，可以致动所述击发触发器121，以便切割和缝合被夹持的组织。在一个使用了机械缝合器(即，非马达驱动的缝合器)的实施例中，击发触发器121的致动将会导致手动释放击发按钮111弹出，而这可由用户在该过程中的任何时间使用，以便出于任何临床原因而手动停止缝合钉部署。更具体地，工具100同时借助切割部件119而在组织中产生纵向切口，并且在切口的相对两侧应用缝合线。这种同时的切割和缝合处理避免了在使用仅分别执行切断和缝合的不同手术工具来按顺序执行这些动作时可能出现的复杂状况。缝合钉的击发可以受马达114(如图5所示)的影响。马达114在远侧驱动切割部件119，并且切割部件119的移动将会驱动缝合钉钉盒中的缝合钉通过被切断的组织并且背对着闭合的砧部109，其中所述砧部形成或闭合所述缝合钉，以便固定被切断的组织。在一个实施例中，缝合器100可以是被适配成在这里使用的任何适当的马达驱动型手术缝合器，例如在美国申请公开2007/0175962A1中显示和描述的马达驱动型手术缝合器，其中所述公开的内容在这里全部引入作为参考。在另一个实施例中，缝合器100可以是被适配成在这里使用的机械的非马达驱动型缝合器，例如Ethicon Endo-Surgery，Inc.开发的EchelonTM60Stapler。在被用户释放时，击发触发器121返回到图1所示的打开位置。手柄部分102可以包括用于释放锁住的闭合触发器123的释放按钮107。
图5是进一步示出了外科工具***101的主要组件之间的关系的外科工具***101的框图。控制***112与耦合至工具100的一个或多个传感器140以及工具100的手柄部分102进行通信以向用户提供触觉效果。更具体地，控制***112包括用于驱动切割部件119的马达114，用于接收来自工具100的一个或多个传感器140的测量值信号或数据的处理器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，马达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，该组件与缝合器100分离并且经由内部或外部导线电连接到传感器140以及触觉反馈***120。换句话说，控制***112的所有组件全都可以处于同一外部设备单元内。仅仅出于例证目的，图1示出了用于将控制***112电连接到工具100的引线113，以及将控制***112电连接到触知反馈***120的引线117。在另一个实施例中，马达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，马达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缝合器100的手柄部分102之内或其上，并且仅仅经由内部导线电连接到传感器140以及触觉反馈***120。举例来说，在手柄部分102中提供的马达113可以如美国专利申请公开2007/0175962A1所述，其中该公开在这里全部引入作为参考。
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电流传感器、RPM传感器、位移或位置传感器和/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，***评估，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***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的手柄部分102的触觉反馈***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***120的引线或系绳117(参见图1)来传递的。此外，在控制***112与手柄部分102之间还有可能提供另一引线(未显示)，以便为处于手柄部分102内部的低电压执行器电路提供隔离接地线。
触觉反馈***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***120电连接到控制***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***112沿着引线或系绳117向工具100的手柄部分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***112与手柄部分102之间提供第四引线(未显示)，以便为手柄部分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***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手柄部分102的刚度/阻尼的螺线管，改变手柄部分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是在手柄部分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手柄部分102内与外科医生手部的手掌、手指和/或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，但是本领域普通技术人员将会了解，能力小得多的触觉显示器同样是有价值的。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，以便在手柄部分102上移动、锁定和制动显示。例如，在一个实施例中，用于切割和缝合组织的击发触发器121和/或用于夹住组织的闭合触发器123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手柄部分102内与外科医生手部的手掌、手指和/或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。动觉执行器至少能够明显阻碍运动，还能显示制动。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。在图6所描绘的一个实施例中，触知反馈***120涉及的是组织各向异性，以便警告用户在工具100的钳口内部存在不寻常的结构。在使用手术缝合器的外科手术过程中，视觉阻塞将会阻止用户清楚看到处于缝合器钳口内部的所有结构。此外，自动击发***和/或高度机械化的优点消除了缝合器击发的触知组件，由此用户不知道缝合在一起的是什么类型的结构。在工具100的钳口内部有可能无意中夹住了某些不应该缝合的组织，例如瘢痕组织、探针或是鼻胃管。因此，在一个实施例中，工具600包括与工具600耦合的传感器640以及处于控制***中的组织各向异性处理器或算法616。在一个实施例中，传感器640可以是与马达114耦合的电流传感器，例如但不局限于由得克萨斯州Austin的Silicon Labs制造的电流传感器。在另一个实施例中，传感器640是被用于计算马达114的RPM且与马达114耦合的光学编码器磁盘。在再一个实施例中，传感器640是与缝合器600的钳口耦合的压力传感器，用于直接测量沿钳口构件的压力分布。在2007年12月13日提交的美国专利申请11/55,563(律师案卷号IMM273)中描述了用于测量压力分布的适当的压力传感器，其中该申请在这里全部引入作为参考。组织各向异性处理器616持续接收来自一个或多个传感器640的测量值信号，并且通过利用在切割过程中从马达114感测的信息和/或通过利用从缝合器钳口感测到的压力分布来计算/估计在工具600的钳口内部被切割的组织或其他结构的类型。触知映射逻辑118使用算法来将传感器数据映射成用于触觉反馈***120的触觉命令。举例来说，该算法可以包括：将感测/计算得到的传感器信息直接映射成幅度，使用频谱过滤处理来局部映射成扩频触觉信号，将感测/计算得到的传感信息数字滤波成触觉信号，或是对感测/计算得到的信息施加阈值来提供警报。
基于来自传感器640的测量信号，可以将组织各向异性反馈提供给用户。触觉反馈警报可以作为与若干个阈值交叉的传感器测量值来提供，或者可以在这些测量值表明设备钳口中具有不寻常的结构的情况下被提供给用户。例如，该反馈可以包括在传感器测量值通过预设阈值时关于所感测/计算得到的传感器信息的连续实时振动触知显示，或是在切割部件前进时采用由用户感觉的放大的触知手感的形式。在另一个实施例中，如果设备内部的组织/结构不适合被缝合或切割，那么可以给出一个负价振动触知警报，如果设备内部的组织/结构适合缝合或切割，那么可以给出一个正价的振动触知警报。此外，触觉效果可以包括击发触发器121和/或闭合触发器123上的动觉封锁或可变幅度的障碍，以便分别阻止用户切割和缝合和/或钳制组织。此外，触觉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。如果工具100是在训练模式中***作的，那么可以提供封锁，然而如果是在经验模式中操作工具100的，那么可以提供可变幅度的障碍。
在图7所示的另一个实施例中，触知反馈***120向工具用户警告位于工具100的钳口内部的组织的量/厚度，以便警告用户是否在为所选择的钉盒缝合不恰当量的组织。缝合钉钉盒通常是为某个范围的组织和/或血管厚度设定的，并且当夹在钳口构件108、109内部的组织的量没有落入该范围时，应该向用户发出警报。在组织量范围的一端，在缝合器的钳口之间应该捕获足够量的组织，以便确保缝合器能够缝合该组织。如果在用于特定缝合器钉盒的钳口内部没有足够的组织，那么钳口有可能会过于接近，特别是在挤压其远端的时候，并且由此缝合器可能无法有效地在被切断的组织中形成闭合缝合。在所述范围的另一端，被夹住的过量组织可能导致粘合以及不完全的缝合击发。工具700包括与工具700的远端耦合的位移传感器740以及处于控制***中的钉盒确认处理器716。钳口位移可以用处于钳口构件铰链上的电位计或其他适当的位置编码器来测量。在一个实施例中，控制***112使用适当的感测装置来检测***缝合器的缝合器钉盒的类型/大小，以使处理器716执行的计算与选择使用的钉盒相符。在另一个实施例中，用户在图形用户界面(GUI)中输入或选择缝合器钉盒的类型/大小，以使处理器716执行的计算与选择使用的钉盒相符。钉盒确认处理器716持续监视接收自位移/位置测量值，并且根据所述位移/位置测量值来计算/估计位于工具700的钳口内部的组织的量，以便确定当前夹持配置中的缝合处理是否会导致产生不完全的缝合形成。
如果处理器716表明处于缝合器钳口内部的组织的量不适合缝合器钉盒，那么可以向用户提供组织量反馈。例如，如果处于设备内部的组织量不适合被缝合或切割，那么可以给出负价振动感知警报，如果处于设备内部的组织量适合缝合或切割，那么可以给出正价振动触知警报。此外，触觉效果可以包括击发触发器121上的动觉障碍，以便防止用户切割和缝合组织。触觉反馈可以采用不同的模式提供，例如训练模式和经验模式，以便适应对工具具有不同经验程度的用户的需要。在一个实施例中，动觉障碍具有可被用户克服的初始大小，这会触发负价振动触知警报，然后则会触发更大的动觉障碍。如果在经验模式中操作工具，那么可以克服第二动觉障碍，由此将会发生缝合击发，如果在训练模式中操作工具，则可提供封锁动觉障碍。
在图8所示的再一个实施例中，触知反馈***120向工具用户告知外科工具钳口内部的血管组织的呈现。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800包括与工具远端耦合的一个或多个压力传感器840A和一个或多个位移传感器840B，以及处于控制***内部的血管感测处理器816。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***产生的电容性压力传感器阵列而被最有效地实现的。血管感测处理器816持续监测分别从传感器840A、840B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有部分处于工具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或高幅阻碍触发器121。在另一个实施例中，如果组织未被完全封闭，那么可以给出负价振动感知警报。
在另一个实施例中，压力传感器840A、位移传感器840B和血管感测处理器816还可以用于警告工具用户缝合处理是否成功封闭了位于缝合器钳口内部的组织。由于用户在充分封闭之前不应该将夹住的组织从缝合器的钳口中释放，因此，用户必须知道组织是否已被缝合器封闭。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816可以使用来自一个或多个压力传感器840A以及一个或多个位移传感器840B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)。如果在缝合处理完成之后组织被封闭，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，触觉效果可以包括释放按钮107上防止放开夹持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，那么可以给出负价振动触知警报。
在另一个实施例中，压力传感器840A、位移传感器840B和血管感测处理器816还可以用于向工具用户警告处于工具100的钳口内部的组织的长度，以便警告用户是否正在为所选择的钉盒缝合不适当长度的组织。缝合钉盒可以是依照特定的长度提供的，并且当夹在钳口构件108、109内部的组织的长度并未落入该范围时，应该向用户发出警报。更具体地，由于缝合钉只应该在组织所处的位置击发，因此较为期望的是知道有多少钳口构件被组织覆盖。因此，如果组织只覆盖了钳口长度中的最邻近的部分，那么由于缝合钉会被击发到体腔而不是组织内部，因此，用户不会希望在钳口长度的远侧部分内部击发缝合钉。用户应该选择具有恰当长度或缝合钉数量的缝合钉盒，以便确保只在组织所处的位置击发缝合钉。在一个实施例中，控制***112使用适当的感测装置来检测***缝合器的缝合钉盒的长度，以使处理器816执行的计算与选择使用的钉盒相符。在另一个实施例中，用户在图形用户接口(GUI)中输入或选择缝合器钉盒的长度，以使处理器816执行的计算与选择使用的钉盒相符。处理器816持续监测分别从压力传感器840A和位移传感器840B接收的位移和/或压力测量值信号，并且计算/估计位于工具800的钳口内部的组织的长度，从而确定缝合钉盒长度是否适合被夹住的组织。如果处理器816表明处于缝合器钳口内部的组织的长度不适合缝合器钉盒，那么可以向用户提供组织量反馈。例如，如果设备内部的组织长度不适合被缝合或切割，那么所给出的可以是负价振动触知警报，如果设备内部的组织长度适于缝合或切割，那么所给出的可以是正价振动触知警报。此外，触觉效果还可以包括处于击发触发器121上且用于防止用户切割和缝合组织的动觉障碍。触觉反馈可以采用不同的模式提供，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。在一个实施例中，动觉障碍具有一个可以被用户克服的初始幅度，其中该幅度将会触发负价振动触知警报，然后则会触发较高幅度的动觉障碍。如果是在经验模式中操作工具的，那么第二动觉障碍是可以克服的，由此将会击发缝合钉，如果工具在训练模式中***作的，那么可以提供封锁动觉障碍。
在图9所示的另一个实施例中，工具900包括能够测量切割部件119的位移的位移传感器940A，以及用于向用户警告缝合过程中的切割部件119的状态的切割部件状态处理器916。在一个实施例中，为了确定和/或验证切割工具119的位置，工具900还可以包括马达传感器940B。在一个实施例中，马达传感器940B可以是与马达114耦合的电流传感器，例如由得克萨斯州Austin的Silicon Labs制造的电流传感器。在另一个实施例中，马达传感器640是一个用于计算马达114的RPM的光学编码器磁盘或其他适当的速度测量传感器。位移传感器940与切割部件119耦合，以便提供与切割部件119的位置相关的信息。所述位移传感器940可以是安装在驱动马达杆部的位置编码器，线性电位计或者LVDT，或是适合获取切割部件119的位置数据的其他传感器。位移传感器940A和/或马达传感器940B持续向处理器916提供信息，以使处理器916确定切割部件119的位置。
在一个实施例中，切割部件119的位置可以用于提供组织缝循环或治疗何时结束的指示。组织缝合循环的完成需要被指示给用户，以使用户能够继续执行手术，这其中可以包括启动另一个击发循环，复位缝合器和/或移除缝合器的步骤。当切割部件119到达其最远位置时(这表明击发循环已经完成)，触知反馈***120会向用户提供触觉效果。在一个实施例中，触觉效果可以是表明组织缝合循环完成的单个触觉警报，例如振动触觉警告。在另一个实施例中，当切割部件119沿着远侧方向纵向推进时，触觉效果可以包括基于现场位置值的连续反馈。例如具有一系列的递增振幅的振动触知反馈。本领域普通技术人员应该理解，触觉效果可以包括警报和连续反馈。
在另一个实施例中，触觉映射逻辑118可以将命令信号输出到马达114。例如，当切割部件119的位置表明组织缝合处理结束时，触觉映射逻辑118可以输出命令信号来关闭马达114，由此阻止附加的组织切割以及控制缝合器的行为。
除了与切割部件119的位置相关的触觉效果之外，还可以在切割过程中提供与被切割的组织性质相关的触觉反馈。例如可以在触发器121和/或把手105上提供被动动觉阻力。在切割部件119的运动过程中，该动觉阻力可以是所感测到的组织性质的函数。例如，动觉阻力可以根据正被切割的组织的硬度改变，其中所述硬度可以借助处于工具远侧末端的应变仪或是其他适当传感器来感测。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，其中该申请先前已被全部引入作为参考。
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。虽然用于组织各向异性、钉盒确认、血管感测和切割部件位置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，外科缝合工具可以引入上述实施例的任何组合。此外，包括一个或多个上述实施例的外科缝合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，在不同的状况中可以使用正价或负价警报分别指示缝合器的恰当或不恰当使用。脉冲发生的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10，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***1020同时经由触觉执行器124和音频设备或扬声器1026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1026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。
参考图11，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***1120分别借助触觉执行器124、音频设备或者扬声器1026、以及视觉显示器1128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1026、视觉显示器1128中的一个或多个。在这个实施例中，视觉显示器1128是处于手柄部分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1128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。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1128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1128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1128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11的实施例，外科工具的手柄部分还可以包括一个或多个按钮1132。按钮1132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1132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1132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1132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1132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1132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***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***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***中，例如Intuitive Surgical，Inc的da外科***，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***，包括：
可操作用于缝合组织的外科工具，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缝合机构；
在所述外科工具的远侧部分上的与两个相对的钳口构件耦合的位移传感器，其中该位移传感器被配置成监测组织性质；
与传感器电连接的控制***，其中该控制***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；
在所述工具的远侧部分上的切割部件；
与切割部件和缝合机构耦合的击发触发器；以及
包括一个或多个触觉执行器的与柄部耦合且与控制***电连接的反馈***，其中所述控制***将信号命令传递到反馈***，并且反馈***使用信号命令来向柄部生成与位移传感器信息相关的触觉反馈；
其中反馈***被配置为生成触觉反馈，根据来自位移传感器的信息，向用户告知位于两个相对的钳口构件内的组织的厚度，
其中所述一个或多个触觉执行器包括与击发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，
其中控制***包括钉盒确认处理器，所述钉盒确认处理器适于连续监测从位移传感器接收的位移测量，并从位移测量计算位于两个相对的钳口构件内的组织的量，以确定在当前夹持配置中的缝合是否会导致不完整缝合的形成，以及
其中所述钉盒确认处理器适于控制动觉执行器，以在击发触发器上提供动觉障碍，以便如果位于两个相对的钳口构件内的组织的量被检测为不适用于选择的缝合钉盒，则防止用户切割和缝合组织。
2.根据权利要求1所述的外科工具***，还包括第二传感器，其中第二传感器是从下列各项中选出的：与马达耦合且用于驱动组织缝合机构的电流传感器，与马达耦合且用于驱动组织缝合机构的RPM传感器，以及与耦合至工具的远侧部分的两个相对钳口构件相耦合的压力分布传感器，并且其中所述反馈***还适于取决于组织的各向异性产生触觉反馈。
3.根据权利要求1所述的外科工具***，还包括耦合至工具的远侧部分的压力传感器，其中所述反馈***还适于产生触觉反馈，向用户告知血管仅部分位于与工具的远侧部分耦合的两个相对的钳口构件内。
4.根据权利要求1所述的外科工具***，还包括耦合至工具的远侧部分的压力传感器，其中所述反馈***还适于产生触觉反馈，向用户告知血管已经被组织缝合机构完全封闭。
5.根据权利要求1所述的外科工具***，还包括耦合至工具的远侧部分的压力传感器，其中所述反馈***还适于产生触觉反馈，向用户告知位于与工具的远侧部分耦合的两个相对的钳口构件内的组织的长度。
6.根据权利要求1所述的外科工具***，其中所述反馈***还适于取决于切割部件的位置产生触觉反馈。
7.根据权利要求6所述的外科工具***，其中所述反馈***适于在缝合过程结束时产生触觉反馈。
8.根据权利要求1所述的外科工具***，其中所述反馈***还适于产生振动作为触觉反馈。
9.根据权利要求1所述的外科工具***，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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