CN109310429A - 具有检测传感器的外科器械 - Google Patents
具有检测传感器的外科器械 Download PDFInfo
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- CN109310429A CN109310429A CN201780037433.6A CN201780037433A CN109310429A CN 109310429 A CN109310429 A CN 109310429A CN 201780037433 A CN201780037433 A CN 201780037433A CN 109310429 A CN109310429 A CN 109310429A
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Abstract
本公开的各方面提出了在端部执行器处或端部执行器附近具有一个或多个传感器的外科器械,并且所述外科器械被配置成能够帮助检测手术部位处的组织以及其它材料和结构。然后可使用所述检测来辅助布置所述端部执行器,并且确认操作哪些物体,或者替代地,避免哪些物体。传感器的示例包括用于采用多普勒频移原理来检测所述手术部位处的物体移动(诸如血细胞)的激光传感器;检测所述金属的存在的电阻传感器;允许所述手术部位处存在不同类型物质的不同吸收水平的单色光源以及具有小形状因子的近红外光谱仪。
Description
技术领域
本公开涉及外科器械,并且在各种情况下,涉及被设计成用于缝合和切割组织的外科缝合和切割器械及其钉仓。更具体地,本公开总体上涉及具有构造成能够辅助外科手术的各种传感器的医疗装置。具体地,本公开涉及具有一个或多个传感器的医疗装置,以用于检测手术部位处或附近的结构、组织和变化的材料或物质。
背景技术
在手术期间,外科医生将具有足够的训练和经验,以在视觉上识别手术部位处存在的各种生理器官和其它材料。准确识别各种器官或其它材料对于确保进行适当的手术显然至关重要。可以基于先前的经验和对特定器官和组织可能看起来或感觉的训练,以及具有对患者的解剖结构的知识和意识来确定该识别。然而,外科医生几乎没有其它指标能够区分存在的组织类型。另外,人工植入物、组织下面看不见的物质、以及通过先前的手术或摄入物质对患者身体进行的其它修改可能会妨碍外科医生正确识别所有材料或存在于手术部位的结构的能力。而且,在某些情况下,可能难以目视检查健康组织与患病组织之间的差异。因此,在进行手术时具有附加帮助以辅助识别或检测各种生理结构或材料将是有用的。
尽管已研制和使用了若干装置,但据信在本发明人之前还无人研制出或使用所附权利要求中描述的装置。
发明内容
在一些方面,提供了一种外科器械。在一个方面,提出了一种外科器械,所述外科器械包括:柄部组件;轴,该轴联接到该柄部组件;端部执行器,该端部执行器通过该轴通信地联接到该柄部组件并包括第一钳口和第二钳口,该柄部组件被构造成能够操纵该第一钳口和该第二钳口,以限定打开位置和闭合位置;以及传感器设备,该传感器设备在该轴的远侧端部处,该传感器设备包括至少一个传感器以及至少一个接收器,该传感器被配置成能够将传感器信号传输到手术部位处的患者组织上,该接收器被配置成能够基于该传感器信号的传输来接收患者组织的传感器数据。
在一些方面,外科器械还包括处理器,该处理器被配置成能够访问传感器数据,并且促使基于传感器数据显示患者组织的文本分析或图形分析。
在外科器械的一些方面,至少一个传感器包括激光传感器,并且传感器信号包括激光。
在外科器械的一些方面,传感器数据包括基于激光在患者组织上的折射入射的激光的强度的量度。
在外科器械的一些方面,传感器信号包括传输到患者组织的第一激光脉冲和第二激光脉冲,第一脉冲和第二脉冲分别在第一次和第二次传输;并且传感器数据包括基于第一脉冲的折射的第一定时测量和基于第二脉冲的折射的第二定时测量。
在一些方面,外科器械还包括处理器,该处理器被配置成能够访问第一定时测量和第二定时测量,并且计算这两个测量之间的定时差值。
在外科器械的一些方面,传感器设备还被配置成能够基于所计算的第一定时测量和第二定时测量之间的定时差值的量值来传输具有重复响应模式的激光信号。
在外科器械的一些方面,第二定时测量还基于第一钳口和第二钳口对患者组织的压缩,该压缩促使患者组织在第二脉冲的测量位置处扩张。
在外科器械的一些方面,其中至少一个传感器包括近红外光谱仪传感器,并且传感器信号包括可见光谱中的光的多光谱阵列。
在外科器械的一些方面,传感器数据包括照射到患者组织上的多光谱阵列的光谱仪读数。
在一些方面,外科器械还包括处理器,该处理器被配置成能够访问传感器数据并基于光谱仪读数提供患者组织的物理组成和/或化学组成的分析。
在外科器械的一些方面,处理器还被配置成能够基于光谱仪读数确定患者组织中的化学浓度的异常比例。
在外科器械的一些方面,至少一个传感器包括发光二极管(LED),并且传感器信号包括从LED发射的准直单色光束。
在外科器械的一些方面,至少一个传感器包括热成像传感器,并且传感器信号包括以二维数组表达的患者组织的红外数据。
在外科器械的一些方面,端部执行器还包括电阻传感器,该电阻传感器被配置成能够测量第一钳口和第二钳口之间的电阻水平。
在另一方面,提供了一种外科系统。该外科系统包括外科器械,该外科器械包括:柄部组件;轴,该轴联接到该柄部组件;端部执行器,该端部执行器通过该轴通信地联接到该柄部组件并包括第一钳口和第二钳口,该柄部组件被构造成能够操纵该第一钳口和该第二钳口,以限定打开位置和闭合位置;以及传感器设备,该传感器设备在该轴的远侧端部处,该传感器设备包括至少一个传感器以及至少一个接收器,该传感器被配置成能够将传感器信号传输到手术部位处的患者组织上,该接收器被配置成能够基于该传感器信号的传输来接收患者组织的传感器数据;以及图形显示器,该图形显示器通信地联接到该外科器械,并且被配置成能够显示患者组织的传感器数据的图形表示。
在另一方面,提供了一种计算机可读介质。不具有暂时信号的计算机可读介质包括当由处理器执行时促使所述处理器执行包括以下操作的指令:访问源自传感器信号传输到所述患者组织上的患者组织的传感器数据;传感器信号由外科器械的传感器设备传输;基于传感器数据确定患者组织的物理组成或化学组成;以及促使显示患者组织的传感器数据的图形表示。
上述发明内容仅为例示性的,并非旨在以任何方式进行限制。除了上述例示性方面和特征,参考附图和下述详细说明,其它方面和特征将变得显而易见。
附图说明
本文所述方面的新颖特征在所附权利要求书中进行了详细描述。然而,关于组织和操作方法的方面可结合如下附图参考下述说明更好地理解。
图1为根据本公开的一个或多个方面的具有能够操作地联接到其的可互换轴组件的外科器械的透视图。
图2为根据本公开的一个或多个方面的图1的可互换轴组件和外科器械的分解组件视图。
图3为示出根据本公开的一个或多个方面的图1和图2的可互换轴组件和外科器械的部分的另一分解组件视图。
图4为根据本公开的一个或多个方面的图1至图3的外科器械的一部分的分解组件视图。
图5为根据本公开的一个或多个方面的图4的外科器械的一部分的横截面侧视图,其中击发触发器处于完全致动位置。
图6为根据本公开的一个或多个方面的图5的外科器械的一部分的另一剖视图,其中击发触发器处于致动位置。
图7为根据本公开的一个或多个方面的图7的可互换轴组件的部分的另一分解组件视图。
图8为根据本公开的一个或多个方面的图7至图9的可互换轴组件的一部分的剖视图。
图9为根据本公开的一个或多个方面的可互换轴组件的一部分的另一透视图,其中切换筒安装在其上。
图10为根据本公开的一个或多个方面的可操作地联接到图1的外科器械的一部分的图11所示可互换轴组件的一部分的透视图,图中示出外科器械的击发触发器处于未致动位置。
图11为根据本公开的一个或多个方面的图10的可互换轴组件和外科器械的右侧正视图。
图12为根据本公开的一个或多个方面的可操作地联接到图1的外科器械的一部分的图11所示可互换轴组件的一部分的透视图,图中示出外科器械的闭合触发器处于致动位置,并且其击发触发器处于未致动位置。
图13为根据本公开的一个或多个方面的可操作地联接到图1的外科器械的一部分的可互换轴组件的右侧正视图,图中示出外科器械的闭合触发器处于致动位置,并且其击发触发器也处于致动位置。
图14为根据本公开的一个或多个方面的图1的外科器械的端部执行器的一个方面的分解图。
图15为根据本公开的一个或多个方面当轴组件未联接到外科器械柄部的电连接器时用于使该电连接器掉电的系统的示意图。
图16A至图16B是根据本公开的一个或多个方面的跨越两个图纸的图1的外科器械的电路图。
图17A至图17B为根据本公开的一个或多个方面的图1的外科器械的电路图。
图18为根据本公开的一个或多个方面的图1的外科器械的框图,其中示出柄部组件与功率组件之间、以及柄部组件与可互换轴组件之间的接口。
图19示出了根据本公开的一个或多个方面的用于评估外科器械的切割边缘的锐度的系统的逻辑图。
图20示出了根据本公开的一个或多个方面的用于确定锐度测试构件在各种锐度水平下施加在外科器械的切割边缘上的力的系统的逻辑图。
图21示出了根据本公开的一个或多个方面的用于调整外科器械的操作的过程的一个方面。
图22A描绘了根据本公开的一个或多个方面的围绕组织的医疗装置的示例性端部执行器。
图22B描绘了根据本公开的一个或多个方面的压缩组织的医疗装置的示例性端部执行器。
图23A描绘了根据本公开的一个或多个方面的由压缩组织的医疗装置的端部执行器施加的示例性力。
图23B也描绘了根据本公开的一个或多个方面的由压缩组织的医疗装置的端部执行器施加的示例性力。
图24描绘了根据本公开的一个或多个方面的示例性组织压缩传感器系统。
图25也描绘了根据本公开的一个或多个方面的示例性组织压缩传感器系统。
图26也描绘了根据本公开的一个或多个方面的示例性组织压缩传感器系统。
图27描绘了根据本公开的一个或多个方面的示例性端部执行器通道框架。
图28描绘了根据本公开的一个或多个方面的示例性端部执行器。
图29也描绘了根据本公开的一个或多个方面的示例性端部执行器通道框架。
图30也描绘了根据本公开的一个或多个方面的示例性端部执行器通道框架。
图31也描绘了根据本公开的一个或多个方面的示例性端部执行器通道框架。
图32描绘了根据本公开的一个或多个方面的示例性电极。
图33描绘了根据本公开的一个或多个方面的示例性电极布线系统。
图34也描绘了根据本公开的一个或多个方面的示例性端部执行器通道框架。
图35为根据本公开的一个或多个方面的示例性电路图。
图36也为根据本公开的一个或多个方面的示例性电路图。
图37也为根据本公开的一个或多个方面的示例性电路图。
图38为根据本公开的一个或多个方面的具有可铰接、可互换轴的外科器械的透视图。
图39为根据本公开的一个或多个方面的图38中所示的外科器械的尖端的侧视图。
图40示出了根据本公开的一个或多个方面的外科器械的端部执行器的剖视图。
图41示出了根据本公开的一个或多个方面的反馈系统的逻辑图。
图42示出了根据本公开的一个或多个方面的反馈系统的逻辑图。
图43为根据本公开的一个方面的智能传感器部件的图。
图44示出了根据本公开的一个或多个方面的电路的一个方面,该电路被配置成能够将来自第一传感器和多个第二传感器的信号转换成能够由处理器接收的数字信号。
图45示出了根据本公开的一个或多个方面的钉仓的分解视图的一个方面,该钉仓包括连接到磁场传感器和处理器的挠性缆线。
图46示出了根据本公开的一个或多个方面的图46中所示的具有挠性缆线并且不具有轴组件的端部执行器。
图47和图48示出了根据本公开的一个或多个方面的不具有砧座或钉仓的端部执行器的细长通道部分,以示出图46中所示的挠性缆线如何能够坐置在细长通道内。
图49示出了根据本公开的一个或多个方面的图46至图48中所示的挠性缆线。
图50示出了根据本公开的一个或多个方面的图114和图115中所示的细长通道的近视图,其中钉仓与其联接。
图51和图52示出了根据本公开的一个或多个方面的远侧传感器插头的一个方面,其中图51示出了远侧传感器插头的剖面图并且图52进一步示出了磁场传感器和处理器,该磁场传感器和处理器能够操作地联接到挠性板以使得它们能够通信。
图53示出了根据本公开的一个或多个方面的具有挠性缆线的端部执行器的方面,该挠性缆线能够操作以将电力提供给砧座部分的远侧末端中的传感器和电子器件。
图54为根据本公开的一个或多个方面的外科缝合器械的端部执行器的透视图,该外科缝合器械包括盒通道、定位在盒通道中的钉仓和砧座。
图55是根据本公开的一个或多个方面的图134的外科缝合器械的剖视正视图,其示出了处于未击发位置的滑动件和击发构件。
图56为根据本公开的一个或多个方面描绘处于部分前进位置的图55的滑动件和处于其未击发位置的击发构件的细节图。
图57示出了根据本公开的一个或多个方面的包括第一传感器和第二传感器的端部执行器的一个方面。
图58为示出根据本公开的一个或多个方面的用于确定夹在端部执行器的砧座和钉仓之间的组织节段的厚度的过程的一个方面的逻辑图。
图59为示出根据本公开的一个或多个方面的用于确定夹在端部执行器的砧座和钉仓之间的组织节段的厚度的过程的一个方面的逻辑图。
图60示出了根据本公开的一个或多个方面的包括第一传感器和第二传感器的端部执行器的一个方面。
图61示出了根据本公开的一个或多个方面的包括第一传感器和多个第二传感器的端部执行器的一个方面。
图62示出了根据本公开的一个或多个方面的包括多个传感器的端部执行器的一个方面。
图63示出了根据本公开的一个或多个方面的用于基于多个传感器确定一个或多个组织特性的过程的一个方面的逻辑图。
图64示出了根据本公开的一个或多个方面的端部执行器的一个方面,该端部执行器包括联接到钳口构件的多个传感器。
图65示出了根据本公开的一个或多个方面的钉仓的一个方面,该钉仓包括在其中一体形成的多个传感器。
图66示出了根据本公开的一个或多个方面的用于确定夹在端部执行器内的组织节段的一个或多个参数的过程的一个方面的逻辑图。
图67为示出根据本公开的一个或多个方面包括传感器的端部执行器的一个方面,该传感器具有特定采样率以限制或消除假信号。
图68为示出根据本公开的一个或多个方面用于产生定位在端部执行器的砧座和钉仓之间的组织节段的厚度测量结果的方法的一个方面的逻辑图。
图69A至图69B示出了根据本公开的一个或多个方面的包括压力传感器的端部执行器的一个方面。
图70示出了根据本公开的一个或多个方面的端部执行器的一个方面,该端部执行器包括位于钉仓和钳口构件之间的第二传感器。
图71为示出根据本公开的一个或多个方面的根据图69A至图69B或图70的用于确定夹在端部执行器中的组织节段的厚度的过程的一个方面的逻辑图。
图72示出了根据本公开的一个或多个方面的端部执行器的一个方面,该端部执行器包括位于钉仓和细长通道之间的多个第二传感器。
图73A和图73B进一步示出了根据本公开的一个或多个方面的组织的完全与部分咬合的效果。
图74为示出根据本公开的一个或多个方面的端部执行器的方面,该端部执行器被配置成能够确定切割构件或刀的位置。
图75示出了根据本公开的一个或多个方面的利用红色LED和红外LED操作的编码条的示例。
图76示出了根据本公开的一个或多个方面的包括钉仓的外科器械的端部执行器的局部透视图。
图77示出了根据本公开的一个或多个方面的图76的端部执行器的一部分的正视图。
图78示出了根据本公开的一个或多个方面的图76的外科器械的模块的逻辑图。
图79示出了根据本公开的一个或多个方面的图76的外科器械的切割边缘、光学传感器和光源的局部视图。
图80示出了根据本公开的一个或多个方面的图76的外科器械的切割边缘、光学传感器和光源的局部视图。
图81示出了根据本公开的一个或多个方面的图76的外科器械的切割边缘、光学传感器和光源的局部视图。
图82示出了根据本公开的一个或多个方面的图76的外科器械的切割边缘、光学传感器和光源的局部视图。
图83示出了根据本公开的一个或多个方面的图76的外科器械的切割边缘、光学传感器和光源的局部视图。
图84示出了根据本公开的一个或多个方面的包括锐度测试构件的钉仓的透视图。
图85示出了根据本公开的一个或多个方面的外科器械的模块的逻辑图。
图86示出了根据本公开的一个或多个方面的外科器械的模块的逻辑图。
图87示出了列出根据本公开的一个或多个方面的用于评估外科器械的切割边缘的锐度的方法的逻辑图。
图88示出了列出根据本公开的一个或多个方面的用于确定外科器械的切割边缘是否足够锐利以横切由外科器械捕集的组织的方法的流程图。
图89示出了根据本公开的一个或多个方面的示出预定义组织厚度和对应的预定义阈值力的表格。
图90示出了根据本公开的一个或多个方面的与外科器械的多个马达一起使用的公共控制器的逻辑图。
图91示出了根据本公开的一个或多个方面的具有移除的外部壳体的外科器械的柄部的局部正视图。
图92示出了根据本公开的一个或多个方面的具有移除的外部壳体的外科器械的局部正视图。
图93A示出了根据本公开的一个或多个方面的其中砧座处于闭合位置的端部执行器的侧面角视图,该图示出了位于仓平台的任一侧面上的一个LED。
图93B示出了根据本公开的一个或多个方面的其中砧座处于打开位置的端部执行器的四分之三角视图,以及位于仓平台的任一侧面上的一个LED。
图94A示出了根据本公开的一个或多个方面的其中砧座处于闭合位置的端部执行器的侧面角视图,以及位于仓平台的任一侧面上的多个LED。
图94B示出了根据本公开的一个或多个方面的其中砧座处于打开位置的端部执行器的四分之三角视图,以及位于仓平台的任一侧面上的多个LED。
图95A示出了根据本公开的一个或多个方面的其中砧座处于闭合位置的端部执行器的侧面角视图,以及位于仓平台的任一侧面上的从钉仓的近侧端部到远侧端部的多个LED。
图95B示出了根据本公开的一个或多个方面的其中砧座处于打开位置的端部执行器的四分之三角视图,该图示出了位于仓平台的任一侧面上并且从钉仓的近侧端部到远侧端部的多个LED。
图96为根据本公开的一个或多个方面的外科器械的示例性功率组件的电路图。
图97为根据本公开的一个或多个方面的外科器械的示例性功率组件的电路图。
图98为根据本公开的一个或多个方面的外科器械的控制系统的示意性框图。
图99为根据本公开的一个或多个方面的外科器械的控制系统的示意性框图。
图100为根据本公开的一个或多个方面的包括受控马达驱动电路构造的绝对定位系统的示意图,该受控马达驱动电路构造包括传感器构造。
图101为根据本公开的一个或多个方面的用于绝对定位系统的传感器构造的详细透视图。
图102为根据本公开的一个或多个方面的绝对定位系统的传感器构造的分解透视图,其示出了控制电路板组件和传感器构造元件的相对对齐。
图103为根据本公开的一个或多个方面的包括磁旋转绝对定位系统的绝对定位系统的位置传感器的一个方面的示意图。
图104为根据本公开的一个或多个方面的示出用于控制本文所公开的外科器械的马达的速度和/或可驱动构件的速度的系统的示意图。
图105为根据本公开的一个或多个方面的示出用于控制本文所公开的外科器械的马达的速度和/或可驱动构件的速度的另一个系统的示意图。
图106示出了根据本公开的一个或多个方面的包括传感器的医疗装置,该传感器帮助在手术部位处识别各种组织和其它材料。
图107示出了根据本公开的一个或多个方面的本公开的各种医疗装置的端部执行器还可以或替代地包括缝合器机构的方式。
图108示出了根据本公开的一个或多个方面的使用端部执行器的切割和扣紧元件并且由一个或多个激光传感器辅助的根据外科手术中涉及的本公开的医疗装置的示例性场景。
图109为根据本公开的一个或多个方面的包括图1的医疗器械的外科系统的框图,该医疗器械具有马达驱动的部件和一个或多个传感器,以更好地帮助理解手术部位中存在的组织和其它材料的类型。
图110提供了根据本公开的一个或多个方面的如何使用本文所述的多普勒原理确定血流测量的图形解释的一些方面。
图111提供了根据本公开的一个或多个方面的可以用于执行本文描述的一些激光技术的一些光学物理的示例。
图112A提供了根据本公开的一个或多个方面的使用本文描述的热成像技术的红外读取的灰度图形示例。
图112B提供了根据本公开的一个或多个方面的使用本文描述的热成像技术的红外读取的线条图形示例。
具体实施方式
本申请的申请人拥有以下专利申请,所述专利申请与本申请于同一日期提交且各自全文以引用方式并入本文:
美国专利申请序号____________,名称为“STAPLE FORMATION DETECTIONMECHANISMS”(END7774USNP/150513);
美国专利申请序号____________,名称为“SURGICAL INSTRUMENT WITH IMPROVEDSTOP/START CONTROL DURING A FIRING MOTION”(END7776USNP/150515);
美国专利申请序号____________,名称为“SURGICAL INSTRUMENT WITHADJUSTABLE STOP/START CONTROL DURING A FIRING MOTION”(END7777USNP/150516);
美国专利申请序号____________,名称为“SURGICAL INSTRUMENT WITH MULTIPLEPROGRAM RESPONSES DURING A FIRING MOTION”(END7782USNP/150517);
美国专利申请序号____________,名称为“SURGICAL INSTRUMENT WITH MULTIPLEPROGRAM RESPONSES DURING A FIRING MOTION”(END7783USNP/150518);
美国专利申请序号____________,名称为“MODULAR SURGICAL INSTRUMENT WITHCONFIGURABLE OPERATING MODE”(END7784USNP/150519);
美国专利申请序号____________,名称为“SYSTEMS AND METHODS FORCONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT”(END7785USNP/150520);并且
美国专利申请序号____________,名称为“SYSTEMS AND METHODS FORCONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT”(END7786USNP/150521)。
本公开提供对本发明所公开的结构、功能、制造的原理、设备的用途和方法的全面理解。这些方面的一个或多个示例在附图中示出。本领域的普通技术人员应当理解,本文具体描述并且示于附图中的装置和方法均为非限制性示例。结合一个示例进行图解说明或描述的特征可与其它示例的特征进行组合。此类修改和变型旨在被包括在本公开的范围内。
提供各种示例装置和方法以用于执行腹腔镜式和微创外科手术操作。然而,本领域的普通技术人员将容易理解,本文所公开的各种方法和装置可用于许多外科手术和应用中,包括例如与开放式外科手术相结合。继续参阅本具体实施方式,本领域中的普通技术人员将进一步理解,本文所公开的各种器械可以任何方式插入体内,诸如通过自然腔道、通过形成于组织中的切口或穿刺孔等。器械的工作部分或端部执行器部分可被直接插入患者体内或可通过具有工作通道的进入装置插入,外科器械的端部执行器及细长轴可通过所述工作通道而推进。
本公开的各方面提出了在端部执行器处或附近具有一个或多个传感器的外科器械,并且该外科器械被配置成能够辅助在手术部位处的组织和其它材料和结构的检测。然后可使用该检测来帮助布置端部执行器,并且确认操作哪些物体,或者替代地避免。
在一些方面,一个或多个传感器可包括构造成在可见光谱的一个或多个频率处的一个或多个激光器。接收器也可以存在于端部执行器处或附近。激光和接收器设备可以采用使用多普勒原理的各种技术来基于物体的运动识别物体,诸如在手术部位的暴露的毛细管中行进的血细胞。在一些情况下,所识别的运动速率可以帮助确定手术部位处的血流水平。在其它情况下,基于材料的已知吸收或折射特性,识别的激光吸收或折射水平可帮助识别存在何种类型的材料。在一些方面,其它类似技术,诸如采用近红外光谱,可用于识别或代表手术部位处存在的组织或其它材料。
在一些方面,可以采用其它类型的传感器来检测其它物理标记,诸如CO2水平、Ph水平、电容水平、钙化水平或异常水平的化学物质的存在。基于具有这些类型的物理标记的组织的已知特性,这些传感器的检测可以帮助确定组织类型和组成,以及辅助检测患病或不健康组织的水平。另外,可以基于与这些物理标记相关的这些材料的已知特性来检测非生物材料,诸如人造植入物。在一些情况下,传感器可以包括单色发光二极管(LED),其可以增强在这些不同光下看到差异特征的能力,诸如钙化、纤维组织、瘢痕组织或指示疾病或受损组织的其它状态。
在一些方面,这些各种传感器可以附接到电动外科缝合和切割器械的端部执行器,其中端部执行器构造成在手术部位处抓握、密封和切割组织。外科器械的端部执行器也可包括能够相对于组织运动的切割构件以及用以横切组织的电极。由于这些原因,对于处理医疗装置的外科医生而言,重要的是正确地识别应尽可能准确地操作的组织类型。这就产生了本文公开的传感器。
在描述如结合图106至图112所述的电动缝合和切割器械(外科器械)的各个方面之前,本公开首先转向图1至图105,以获得机械和电平台的一般描述,本发明的电动外科器械可以在其上实施,并提供理解电动外科器械的基本操作和功能所必需的背景。因此,图1至图14提供了基本机械平台的一般描述的示例,在该机械平台上可以实现本发明的电动缝合和切割器械。图15至图21描述了可以在其上实现本发明的电动外科器械的一般基本微控制器、马达驱动器和电互连平台的示例。图22至图34描述了示例性端部执行器通道框架和施加到位于砧座和端部执行器的钉仓之间的组织的测量力。图35至图37描述了用于控制本电动外科器械的功能的示例性电路。图38至图95描述了利用传感器输出来实现本电动外科器械的示例性传感器和反馈系统。图97至图97描述了用于为本电动外科器械提供功率的示例性功率组件。图98至图105描述了用于控制本外科器械的马达速度和可驱动构件的示例性控制系统,包括传感器和用于其的反馈元件。在熟悉可以在其上实施本电动外科器械的基本机械和电平台之后,为了描述具有检测传感器的外科器械装置,读者可以参考结合图106至图112的描述。
因此,现在转到附图,图1至图6描绘了用于切割和紧固的马达驱动的外科器械10,其可以重复使用或不重复使用。在所示示例中,外科器械10包括外壳12,该外壳包括被构造成能够由临床医生抓握、操纵并致动的柄部组件14。外壳12被构造成能够可操作地附接到可互换轴组件200,该可互换轴组件具有可操作地联接到其上的端部执行器300,该端部执行器被构造成能够执行一种或多种手术任务或外科手术。继续参阅本具体实施方式,将会理解,本文所公开的各种形式的可互换轴组件的各种独特和新颖的布置也可有效地与机器人控制的外科系统结合使用。因此,术语“外壳”也可涵盖机器人系统的容纳或以其它方式可操作地支撑至少一个驱动系统的外壳或类似部分,所述至少一个驱动系统被配置成能够生成并施加可用于致动本文所公开的可互换轴组件及其相应的等同物的至少一种控制动作。术语“框架”可指手持式外科器械的一部分。术语“框架”还可表示机器人控制的外科器械的一部分和/或机器人系统的可用于以可操作的方式控制外科器械的一部分。例如,本文所公开的可互换轴组件可用于公开在以下专利申请公布的各种机器人系统、器械、部件和方法:名称为“SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS”的美国专利号9,072,535,该专利申请公布全文以引用方式并入本文。
图1至图2中所示的外壳12结合包括端部执行器300的可互换轴组件200示出,所述端部执行器包括被构造成能够可操作地支撑其中的外科钉仓304的外科切割和紧固装置。外壳12可被构造用于与可互换轴组件结合使用,该可互换轴组件包括端部执行器,该端部执行器适于支撑不同尺寸和类型的钉仓,具有不同的轴长度、尺寸和类型等。另外,外壳12还可有效地用于多种其它可互换轴组件,其包括被配置成能够将其它运动和形式的能量(诸如例如射频(RF)能量、超声能量和/或运动)施加到适合与各种外科应用和手术结合使用的端部执行器布置的那些组件。此外,该端部执行器、轴组件、柄部、外科器械和/或外科器械系统可利用任何一种或多种合适的紧固件来紧固组织。例如,包括可移除地被存储在其中的多个紧固件的紧固件仓能够可移除地插入轴组件的端部执行器中和/或附接到轴组件的端部执行器。
图1示出了具有可操作地联接至其的可互换轴组件200的外科器械10。图2示出了可互换轴组件200至外壳12或柄部组件14的附接。如图4所示,柄部组件14可以包括一对可互连柄部外壳段16和18,该对柄部外壳段可通过螺钉、按扣特征结构、粘合剂等互连。在所示构造中,柄部外壳段16、18配合以形成可被临床医生抓握和操纵的手枪式握把部19。如将在下文更详细所述的,柄部组件14在其中操作地支撑多个驱动系统,该多个驱动系统被配置成能够生成并将各种控制运动施加到操作地附接到其的可互换轴组件的对应部分。
现在参见图4,柄部组件14还可包括可操作地支撑多个驱动系统的框架20。例如,框架20可操作地支撑通常被标记为30的“第一”或闭合驱动系统,该“第一”或闭合驱动系统可用于将闭合和打开运动施加到操作地附接或联接到其的可互换轴组件200。在至少一种形式中,闭合驱动系统30可包括被框架20枢转地支撑的闭合触发器32形式的致动器。更具体地,如图4所示,闭合触发器32通过枢转销33以能够枢转的方式联接到柄部组件14。此类构造使得闭合触发器32将能够由临床医生操纵,使得当临床医生握持柄部组件14的手枪式握持部部19时,闭合触发器32可容易从启动或“未致动”位置枢转到“致动”位置并且更具体地枢转到完全压缩或完全致动位置。闭合触发器32可由弹簧或其它偏压布置(未示出)偏压到未致动位置中。在各种形式中,闭合驱动系统30还包括可枢转地联接到闭合触发器32的闭合连杆组件34。如图4所示,闭合连杆组件34可包括由销35枢转地联接到闭合触发器32的第一闭合连杆36和第二闭合连杆38。第二闭合连接件38在本文中也可称为“附接构件”,并且包括横向附接销37。
仍参见图4,可观察到,第一闭合连接件36可在其上具有端部或锁定壁39,该端部或锁定壁被构造成能够与枢转地联接到框架20的闭合释放组件60配合。在至少一种形式中,闭合释放组件60可包括具有在其上形成的朝远侧突起的锁定棘爪64的闭合释放按钮组件62。闭合释放按钮组件62可被释放弹簧(未示出)沿逆时针方向枢转。临床医生将闭合触发器32从其未致动位置朝向柄部组件14的手枪式握把部19按压时,第一闭合连接件36向上枢转至某个点,其中锁定爪64落入该点中以与第一闭合连接件36上的锁定壁39保持接合,从而阻止闭合触发器32返回未致动位置。因此,闭合释放组件60用来将闭合触发器32锁定在完全致动位置。当临床医生期望将闭合触发器32解锁以允许其被偏压到未致动位置时,临床医生只需枢转闭合释放按钮组件62,使得锁定爪64运动成与第一闭合连接件36上的锁定壁39脱离接合。当锁定棘爪64已运动成与第一闭合连接件36脱离接合时,闭合触发器32可枢转回到未致动位置。也可采用其它闭合触发器锁定构造和释放构造。
除上述之外,图10至图11示出了处于未致动位置的闭合触发器32,该未致动位置与可互换轴组件200的打开或未夹紧构型相关联,在该构型中,组织可定位在可互换轴组件200的钳口之间。图12示出了处于致动位置的闭合触发器32,该致动位置与可互换轴组件200的闭合或夹持构型相关联,在该构型中,组织被夹持在可互换轴组件200的钳口之间。读者在将图11与图13比较之后将会知道,当闭合触发器32从其未致动位置(图11)向其致动位置(图13)运动时,闭合释放按钮组件62在第一位置(图11)与第二位置(图13)之间枢转。闭合释放按钮组件62的旋转可被称为向上旋转;然而,闭合释放按钮组件62的至少一部分朝电路板100旋转。参见图4,闭合释放按钮组件62可包括从其延伸的臂61和安装到臂61的磁性元件63(诸如永磁体)。当闭合释放按钮组件62被从其第一位置旋转到其第二位置时,磁性元件63可朝电路板100运动。电路板100可包括被配置成能够检测磁性元件63的移动的至少一个传感器。在至少一个方面,例如,磁场传感器65可安装到电路板100的底部表面。磁场传感器65可被配置成能够检测由磁性元件63的运动引起、环绕磁场传感器65的磁场变化。磁场传感器65可例如与控制器1500进行信号通信,该微控制器可确定闭合释放按钮组件62是处于其第一位置、其第二位置,还是/或者第一位置与第二位置之间的任何位置,该第一位置与闭合触发器32的未致动位置和端部执行器的打开构型相关联,该第二位置与闭合触发器32的致动位置和端部执行器的闭合构型相关联。
如在整个本公开中所使用的,磁场传感器可以是霍尔效应传感器、探测线圈、磁通门、光泵、核旋、超导量子干涉仪(SQUID)、霍尔效应、各向异性磁电阻、巨磁电阻、磁性隧道结、巨磁阻抗、磁致伸缩/压电复合材料、磁敏二极管、磁敏晶体管、光纤、磁光,以及基于微机电系统的磁性传感器等。
在至少一种形式中,柄部组件14和框架20可以可操作地支撑在本文中被称为击发驱动系统80的另一个驱动系统,该驱动系统被配置成能够将击发动作施加到附接到其上的可互换轴组件的对应部分。击发驱动系统80也可在本文中被称为“第二驱动系统”。击发驱动系统80可采用位于柄部组件14的手枪式握持部部19中的电动马达82。在各种形式中,电动马达82例如可以是具有约25,000RPM的最大旋转的直流有刷驱动马达。在其它构造中,马达可包括无刷马达、无绳马达、同步马达、步进马达、或任何其它合适的电动马达。电动马达82可由功率源90供电,在一种形式中,该功率源可包括可移除电源组92。如图4所示,例如,可移除电源组92可包括近侧外壳部分94,该近侧外壳部分被构造用于附接到远侧外壳部分96。近侧外壳部分94和远侧外壳部分96被构造成能够可操作地支撑其中的多个电池98。电池98可各自包括例如锂离子(“LI”)或其它合适的电池。远侧外壳部分96被构造用于以可移除方式可操作地附接到同样可操作地联接到电动马达82的控制电路板100。可使用可串联连接的多个电池98作为外科器械10的功率源。除此之外,功率源90可以是可替换的和/或可再充电的。
如上面相对于其它各种形式所概述,电动马达82可包括与齿轮减速器组件84可操作地交接的可旋转轴(未示出),该齿轮减速器组件被安装成与纵向可动驱动构件120上的一组或一齿条的驱动齿122啮合接合。在使用中,功率源90所提供的电压极性可沿顺时针方向操作电动马达82,其中由电池施加给电动马达的电压极性可被反转,以便沿逆时针方向操作电动马达82。当电动马达82在一个方向上旋转时,纵向可动驱动构件120将在远侧方向“DD”上轴向地驱动。当电动马达82在相反的旋转方向上被驱动时,纵向可动驱动构件120将在近侧方向“PD”上轴向地驱动。柄部组件14可包括开关,该开关被配置成能够使由功率源90施加到电动马达82的极性反转。如同本文所述的其它形式一样,柄部组件14还可包括传感器,所述传感器被配置成能够检测纵向可动驱动构件120的位置和/或纵向可动驱动构件120移动的方向。
电动马达82的致动由被枢转地支撑在柄部组件14上的击发触发器130控制。击发触发器130可在未致动位置和致动位置之间枢转。击发触发器130可由弹簧132或其它偏压构造偏压到未致动位置中,使得当临床医生释放击发触发器130时,击发触发器可由弹簧132或偏压构造枢转或以其它方式返回到未致动位置。在至少一种形式中,击发触发器130可如上所述被定位在闭合触发器32的“外侧”。在至少一种形式中,击发触发器安全按钮134可由销35枢转地安装到闭合触发器32。击发触发器安全按钮134可定位在击发触发器130和闭合触发器32之间,并具有从其突起的枢转臂136。参见图4。当闭合触发器32处于未致动位置时,击发触发器安全按钮134被容纳在柄部组件14中,此时临床医生可能无法轻易触及该按钮,也无法将该按钮在防止对击发触发器130致动的安全位置与击发触发器130可被击发的击发位置之间运动。临床医生按压闭合触发器32时,击发触发器安全按钮134和击发触发器130向下枢转,随后可被临床医生操纵。
如上文所讨论,柄部组件14可包括闭合触发器32和击发触发器130。参见图11至图13,击发触发器130能够可枢转地安装到闭合触发器32。闭合触发器32可包括从其延伸的臂31,击发触发器130可围绕枢轴销33可枢转地安装到臂31。如上文所概述,当闭合触发器32从其未致动位置(图11)向其致动位置(图13)运动时,击发触发器130可向下下降。在击发触发器安全按钮134已运动到其击发位置之后,主要参见图18A,可按压击发触发器130,以操作外科器械击发系统的马达。在各种情况下,柄部组件14可包括跟踪系统(诸如系统800),该跟踪系统被配置成能够确定闭合触发器32的位置和/或击发触发器130的位置。主要参照图11和图13,跟踪系统800可包括磁性元件(诸如磁体802),该磁性元件安装到从击发触发器130延伸的臂801。跟踪系统800可包括一个或多个传感器,诸如第一磁场传感器803和第二磁场传感器804,这些传感器可被配置成能够跟踪磁体802的位置。
读者在将图11与图13比较之后将会知道,当闭合触发器32从其未致动位置向其致动位置运动时,磁体802可在邻近第一磁场传感器803的第一位置与邻近第二磁场传感器804的第二位置之间运动。
读者在将图11与图13比较之后将进一步知道,当击发触发器130从未击发位置(图11)向击发位置(图13)运动时,磁体802可相对于第二磁场传感器804运动。第一磁场传感器和第二磁场传感器803、804可跟踪磁体802的运动,并且可与电路板100上的控制器进行信号通信。控制器可利用来自第一磁场传感器803和/或第二磁场传感器804的数据,确定磁体802沿预定义的路径的位置,并且控制器可基于该位置,确定闭合触发器32是处于其未致动位置、其致动位置、还是其未致动位置和其致动位置之间的位置。相似地,控制器可利用来自第一磁场传感器803和/或第二磁场传感器804的数据,确定磁体802沿预定义的路径的位置,并且控制器可基于该位置,确定击发触发器130是处于其未击发位置、其完全击发位置、还是其未击发位置和其完全击发位置之间的位置。
如上所述,在至少一种形式中,可纵向运动的驱动构件120具有在其上形成的一齿条的驱动齿122,以用于与齿轮减速器组件84的相应驱动齿轮86啮合。至少一种形式还包括可手动致动的被配置成能够使得临床医生能够在电动马达82变得失效情况下手动地回缩可纵向运动的驱动构件120的救助组件140。救助组件140可包括杠杆或柄部组件14,该杠杆或救助柄部组件被构造成能够被手动地枢转为与同样设置在纵向可动驱动构件120中的齿124棘轮接合。因此,临床医生可通过使用柄部组件14来手动地回缩纵向可动驱动构件120,以在近侧方向PD上啮合纵向可动驱动构件120。名称为“POWERED SURGICAL CUTTING ANDSTAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM”的美国专利号8,608,045公开了也可与本文所公开的各种器械一起使用的救助构造和其它部件、构造和系统。美国专利号8,608,045中有所描述,据此全文以引用方式并入本文。
现在转到图1,可互换轴组件200包括端部执行器300,该端部执行器包括被构造成能够可操作地支撑其中的外科钉仓304的细长通道302。端部执行器300还可包括砧座306,该砧座相对于细长通道302可枢转地支撑。可互换轴组件200还可包括关节运动接口270和关节运动锁350(图7),该关节运动锁可被构造成能够可释放地将端部执行器300相对于轴轴线SA-SA保持在期望的位置。有关端部执行器300、关节运动接口270和关节运动锁350的构造和操作的细节在美国专利申请公布2014/0263541中提出,名称为“ARTICULATABLESURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK”,该文献全文以引用方式并入本文。如图7所示,可互换轴组件200还可包括由喷嘴部分202、203构成的近侧外壳或喷嘴201。可互换轴组件200还可包括闭合管260,该闭合管可用于闭合和/或打开端部执行器300的砧座306。现在主要参见图7,可互换轴组件200可包括可被构造成能够可固定地支撑关节运动锁350的轴框架212的脊210。参见图7。脊210可被构造成能够:第一,可滑动地支撑其中的击发构件220;第二,可滑动地支撑围绕脊210延伸的闭合管260。脊210还可被构造成能够可滑动地支撑关节运动驱动器230。关节运动驱动器230具有远侧端部231,该远侧端部被构造成能够可操作地接合关节运动锁350。关节运动锁350与关节运动框架352交接,该关节运动框架能够可操作地接合端部执行器框架(未示出)上的驱动销(未示出)。如上所述,有关关节运动锁350和关节运动框架的操作的更多细节可见于美国专利申请公开2014/0263541。在各种情况下,脊210可包括可旋转地支撑在底座240中的近侧端部211。在一种构造中,例如,脊210的近侧端部211具有在其上形成的螺纹214,以便通过螺纹附接到被构造成能够被支撑在底座240内的脊轴承216。此类构造有利于脊210到底盘240的可旋转附接,使得脊210可相对于底盘240围绕轴轴线SA-SA选择性地旋转。
可互换轴组件200包括闭合梭动件250,该闭合梭动件以可相对于底座240轴向运动的方式可滑动地支撑在该底座内。如图3所示,闭合梭动件250包括被构造成能够附接到横向附接销37的一对朝近侧突起的钩252,该横向附接销附接到第二闭合连杆38,如将在下文进一步详细地讨论。闭合管260的近侧端部261联接到闭合梭动件250,以相对于闭合梭动件旋转。例如,将U形连接器263插入闭合管260的近侧端部261中的环形狭槽262中,使其保留在闭合梭动件250中的竖直狭槽253内。此类构造用于将闭合管260附接到闭合梭动件250,以与闭合梭动件一起轴向行进,同时使得闭合管260能够围绕轴轴线SA-SA相对于闭合梭动件250旋转。闭合弹簧268轴颈连接在闭合管260上并且用于将闭合管260朝近侧方向“PD”偏压,这可在轴组件操作地联接到柄部组件14时用于将闭合触发器枢转到未致动位置中。
在至少一种形式中,可互换轴组件200还可包括关节运动接口270。然而,其它可互换轴组件可能无法进行关节运动。根据各种形式,双枢轴闭合套管组件271包括具有朝远侧突出的上柄脚273和下柄脚274的端部执行器闭合套管组件272。端部执行器闭合套管组件272包括马蹄形孔275和插片276,用于以美国专利申请公开2014/0263541中描述的各种方式接合砧座306上的开口插片。如本文进一步详细地描述,当砧座306打开时,马蹄形孔275和插片276与砧座上的插片接合。上部双枢轴连接件277包括向上突出的远侧枢轴销和近侧枢轴销,这些枢轴销分别接合闭合管260上的朝近侧突出的上柄脚273中的上部远侧销孔以及朝远侧突出的上柄脚264中的上部近侧销孔。下部双枢轴连接件278包括向上突出的远侧枢轴销和近侧枢轴销,这些枢轴销分别接合朝近侧突出的下柄脚274中的下部远侧销孔以及朝远侧突出的下柄脚265中的下部近侧销孔。还参见图7。
在使用中,闭合管260朝远侧(方向“DD”)平移,以(例如)响应于闭合触发器32的致动而闭合砧座306。砧座306通过朝远侧平移闭合管260并且因此端部执行器闭合套筒组件272,从而使其以描述于上述参考文献美国专利申请公布号2014/0263541中的方式撞击砧座306上的近侧表面而闭合。还如该参考文献中所详述,通过朝近侧平移闭合管260和端部执行器闭合套管组件272,致使插片276和马蹄形孔275接触并推压砧座插片以将砧座306抬起,由此打开砧座306。在砧座打开位置,闭合管260运动至其近侧位置。
如上所述,外科器械10还可包括其类型和构造在美国专利申请公开2014/0263541中进一步详细描述的关节运动锁350,该关节运动锁可被构造成能够操作以选择性地将端部执行器300锁定在适当的位置。当关节运动锁350处于其解锁状态时,此类构造使端部执行器300能够相对于闭合管260旋转或做关节运动。在这种解锁状态下,端部执行器300可抵靠例如围绕患者体内手术部位的软组织和/或骨定位和推压,以使端部执行器300相对于闭合管260做关节运动。端部执行器300也可在关节运动驱动器230作用下,相对于闭合管260做关节运动。
同样如上所述,可互换轴组件200还包括击发构件220,该击发构件被支撑以便在脊210内轴向行进。击发构件220包括被构造成能够附接到远侧切割部分或刀杆280的中间击发轴222。击发构件220在本文中也可被称为“第二轴”和/或“第二轴组件”。如图7所示,中间击发轴222可在其远侧端部中包括纵向狭槽223,该纵向狭槽可被构造成能够接收刀杆280的近侧端部282上的插片284。纵向狭槽223和近侧端部282可被设定尺寸并被构造成能够允许它们之间的相对运动并且可包括滑动接头286。滑动接口286可允许击发驱动构件220的中间击发轴222运动,以在不运动或至少基本上不运动刀杆280的情况下,使端部执行器300做关节运动。一旦端部执行器300已合适地取向,中间击发轴222便可朝远侧推进,直到纵向狭槽223的近侧侧壁与插片284发生接触,以便推进刀杆280并击发定位在通道302内的钉仓。如图7中可进一步看到的那样,脊210在其中具有细长的开口或窗口213,以利于将中间击发轴222装配和插入到脊210中。一旦中间击发轴222已被插入轴框架中,顶部框架段215就可与轴框架212接合,以封闭其中的中间击发轴222与刀杆280。有关击发构件220的操作的进一步描述可见于美国专利申请公开2014/0263541。
除上述之外,可互换轴组件200可包括离合器组件400,该离合器组件可被构造成能够选择性地和可释放地将关节运动驱动器230联接到击发构件220。在一种形式中,离合器组件400包括围绕击发构件220定位的锁定衬圈或锁定套筒402,其中锁定套筒402可在接合位置与脱离位置之间旋转,在接合位置处,锁定套筒402将关节运动驱动器360联接到击发构件220,在脱离位置处,关节运动驱动器360没有可操作地联接到击发构件220。当锁定套筒402处于其接合位置时,击发构件220的远侧移动可朝远侧移动关节运动驱动器360;并且相应地,击发构件220的近侧移动可朝近侧移动关节运动驱动器230。当锁定套筒402处于其脱离位置时,击发构件220的移动未被传输至关节运动驱动器230;并且因此,击发构件220可独立于关节运动驱动器230移动。在各种情况下,当关节运动驱动器230未由击发构件220朝近侧方向或远侧方向移动时,关节运动驱动器230可由关节运动锁350保持在适当的位置。
如图7至图9所示,可互换轴组件200还包括可旋转地接纳在闭合管260上的切换筒500。切换筒500包括中空轴段502,该中空轴段具有在其上形成的轴凸台504,以用于将向外突出的致动销410接纳在其中。在各种情况下,致动销410延伸穿过狭槽267进入被提供在锁定套筒402中的纵向狭槽408,以有利于锁定套筒402在其与关节运动驱动器230接合时的轴向移动。旋转扭转弹簧420被构造成能够如图8所示接合切换筒500上的轴凸台504以及喷嘴部分203的一部分,以将偏置力施加到切换筒500。参见图5和图6,切换筒500还可包括其中限定的至少部分周边的开口506,这些开口可被构造成能够接收从喷嘴部分202、203延伸的周边安装架204、205,并允许切换筒500与喷嘴201之间相对旋转而不是相对平移。如这些图所示,周边安装架204、205还延伸穿过闭合管260中的开口266以安置在位于脊210中的凹陷部中。然而,喷嘴201旋转到某个点(在该点处,周边安装架204、205到达它们各自的部分周边的开口506在切换筒500中的末端)将导致切换筒500围绕轴轴线SA-SA旋转。切换筒500的旋转最终将导致致动销410和锁定套筒402在其接合位置和脱离位置之间的旋转。因此,实质上,喷嘴201可用于以在美国专利申请公布号2014/0263541中更详细描述的各种方式来使关节运动驱动系统与击发驱动系统操作地接合和脱离接合。
也如图7至图9所示,可互换轴组件200可包括滑环组件600,例如,该滑环组件可被配置成能够将电力传导至端部执行器300和/或从该端部执行器传导电力,并且/或者将信号传送至端部执行器300和/或从该端部执行器接收信号。滑环组件600可包括近侧连接器凸缘604和远侧连接器凸缘601,该近侧连接器凸缘安装到从底座240延伸的底座安装凸缘242,该远侧连接器凸缘定位在喷嘴部分202、203中限定的狭槽内。近侧连接器法兰604可包括第一面,并且远侧连接器法兰601可包括第二面,其中第二面与第一面相邻定位,并能够相对于第一面运动。远侧连接器法兰601可围绕轴轴线SA-SA相对于近侧连接器法兰604旋转。近侧连接器法兰604可包括限定在其第一面中的多个同心或至少基本上同心的导体602。连接器607可安装在远侧连接器法兰601的近侧面上,并可具有多个触点(未示出),其中每个触点与导体602中的一者对应并与其电接触。这种构造在保持近侧连接器凸缘604与远侧连接器凸缘601之间电接触的同时,允许这两个凸缘之间相对旋转。例如,近侧连接器凸缘604可包括电连接器606,该电连接器可使导体602与安装到底座240的轴电路板610进行信号通信。在至少一种情况下,包括多个导体的线束可在电连接器606与轴电路板610之间延伸。电连接器606可朝近侧延伸穿过底座安装法兰242中限定的连接器开口243。名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM”的美国专利申请公开2014/0263551的全文以引用方式并入本文。名称为“STAPLE CARTRIDGE TISSUE THICKNESSSENSOR SYSTEM”的美国专利申请公开2014/0263552的全文以引用方式并入本文。有关滑环组件600的更多细节可见于美国专利申请公开2014/0263541。
如上文所讨论,可互换轴组件200可包括可固定地安装到柄部组件14的近侧部分,以及可围绕纵向轴线旋转的远侧部分。可旋转远侧轴部分可如上所述围绕滑动环组件600相对于近侧部分旋转。滑环组件600的远侧连接器法兰601可定位在可旋转的远侧轴部分内。而且,除上述之外,切换筒500也可定位在可旋转的远侧轴部分内。当可旋转的远侧轴部分旋转时,远侧连接器法兰601和切换筒500可彼此同步地旋转。另外,切换筒500可相对于远侧连接器法兰601在第一位置与第二位置之间旋转。当切换筒500处于其第一位置时,关节运动驱动系统可与击发驱动系统可操作地脱离接合,因此,击发驱动系统的操作可不使可互换轴组件200的端部执行器300进行关节运动。当切换筒500处于其第二位置时,关节运动驱动系统能够可操作地与击发驱动系统接合,因此,击发驱动系统的操作可以使可互换轴组件200的端部执行器300做关节运动。当切换筒500在其第一位置和其第二位置之间运动时,切换筒5500相对于远侧连接器法兰601运动。在各种示例中,可互换轴组件200可包括被配置成能够检测开关鼓500的位置的至少一个传感器。现在转到图9,远侧连接器凸缘601可包括例如磁场传感器605,切换筒500可包括例如磁性元件,诸如永磁体505。磁场传感器605可被配置成能够检测永磁体505的位置。当切换筒500在其第一位置和其第二位置之间旋转时,永磁体505可相对磁场传感器605运动。在各种情况下,磁场传感器605可检测当永磁体505运动时产生的磁场变化。磁场传感器605可例如与轴电路板610和/或位于柄部中的电路板100进行信号通信。基于来自磁场传感器605的信号,轴电路板610和/或位于柄部中的电路板100上的控制器可确定关节运动驱动系统是否与击发驱动系统接合或脱离接合。
再次参见图3,底盘240包括在其上形成的至少一个且优选两个锥形附接部分244,该锥形附接部分适于容纳于在框架20的远侧附接凸缘700内形成的相应燕尾槽702内。每个燕尾形狭槽702可以是锥形,或换句话讲,可以略成V形,从而以坐置方式将锥形附接部分244接收在其中。如可在图3中进一步所见,轴附接耳状物226在中间击发轴222的近侧端部上形成。如将在下文进一步详细地讨论,当可互换轴组件200联接到柄部组件14时,轴附接耳状物226被接收在纵向可动驱动构件120的远侧端部125中形成的击发轴附接支架126中,例如,如图3和图6所示。
各种轴组件采用闩锁系统710以可移除地将可互换轴组件200联接到外壳12,更具体地,联接到框架20。朝近侧突起的锁定耳状物714各自具有在其上形成的枢轴锁定耳状物716,这些枢轴锁定耳状物适于被接收在底座240中形成的对应孔245中。此类构造有利于将锁定轭712枢转附接到底座240。锁定轭712可包括两个朝近侧突起的锁定耳状物714,这两个锁定耳状物被构造成能够与框架20的远侧附接凸缘700中对应的锁定棘爪或凹槽704可释放地接合。参见图3。在各种形式中,锁定轭712被弹簧或偏置构件(未示出)沿近侧方向偏置。锁定轭712的致动可通过可滑动地安装在闩锁致动器组件720上的闩锁按钮722来实现,该闩锁致动器组件安装到底盘240。闩锁按钮722可相对于锁轭712沿近侧方向偏置。如将在下文进一步详细地讨论,锁定轭712可通过沿远侧方向偏置闩锁按钮而运动到解锁位置,这也使锁定轭712枢转成不再与框架20的远侧附接凸缘700保持接合。当锁定轭712与框架20的远侧附接凸缘700“保持接合”时,锁定耳状物716保持坐置在远侧附接凸缘700中对应的锁定棘爪或凹槽704内。
当采用包括适于切割和紧固组织的本文所述类型的端部执行器以及其它类型的端部执行器的可互换轴组件时,可能有利的是防止可互换轴组件在端部执行器致动期间不经意地从外壳脱离。例如,在使用中,临床医生可致动闭合触发器32以抓持目标组织并将其操纵成期望的位置。一旦目标组织以期望取向定位在端部执行器300内,临床医生就可完全致动闭合触发器32,以闭合砧座306并将目标组织夹持在合适位置供切割与缝合。在这种情况下,第一驱动系统30已被完全致动。在目标组织已被夹持在端部执行器300中之后,可能有利的是防止可互换轴组件200不经意地从外壳12脱离。闩锁系统710的一种形式被构造成能够防止这种不经意的脱离。
锁定轭712包括至少一个且优选两个锁定钩718,这些锁定钩适于接触在闭合梭动件250上形成的锁定耳状物256。参见图10和图11,当闭合梭动件250处于未致动位置(即,第一闭合驱动系统30未致动并且砧座306打开)时,锁定轭712可沿远侧方向枢转,以将可互换轴组件200从外壳12解锁。当处于该位置时,锁定钩718不接触闭合梭动件250上的锁定耳状物256。然而,当闭合梭动件250运动到致动位置(即,第一闭合驱动系统30被致动并且砧座306处于闭合位置)时,锁定轭712被阻止枢转到解锁位置。参见图12和图13。换句话讲,如果临床医生试图将锁定轭712枢转到解锁位置,或者例如,锁定轭712不经意地以原本可能引起其朝远侧枢转的方式受到碰撞或发生接触,则锁定轭712上的锁定钩718将接触闭合梭动件250上的锁定耳状物256,并且防止锁定轭712运动到解锁位置。
现在将参照图3描述可互换轴组件200与柄部组件14附接的操作。要开始联接过程,临床医生可将可互换轴组件200的底座240定位在框架20的远侧附接凸缘700上方或附近,使得底座240上形成的锥形附接部分244与框架20中的燕尾形狭槽702对齐。然后临床医生可沿垂直于轴轴线SA-SA的安装轴线IA运动可互换轴组件200,以使锥形附接部分244坐置成与对应的燕尾形接收狭槽702“可操作地接合”。这样做时,中间击发轴222上的轴附接耳状物226也将坐置在可纵向运动的驱动构件120中的击发轴附接支架126中,并且第二闭合连杆38上的横向附接销37的部分将坐置在闭合梭动件250中的对应朝近侧突起的钩252中。如本文所用,术语“可操作地接合”在两个部件的背景下是指这两个部件彼此充分地接合,使得一旦向其施加致动运动,这些部件便可以执行其预期行动、功能和/或程序。
如上文所讨论,可互换轴组件200的至少五个系统能够可操作地与柄部组件14的至少五个对应系统联接。第一系统可包括框架系统,该框架系统将可互换轴组件200的框架或脊与柄部组件14的框架20联接和/或对齐。第二系统可包括闭合驱动系统30,该闭合驱动系统可将柄部组件14的闭合触发器32与可互换轴组件200的闭合管260和砧座306可操作地连接。如上文所概述,可互换轴组件200的闭合梭动件250可与第二闭合连杆38上的横向附接销37接合。第三系统可包括击发驱动系统80,该击发驱动系统可将柄部组件14的击发触发器130与可互换轴组件200的中间击发轴222可操作地连接。
如上文所概述,轴附接耳状物226可与纵向可动驱动构件120的击发轴附接支架126可操作地连接。第四系统可包括电气系统,该电气系统能够:发送轴组件(诸如可互换轴组件200)已与柄部组件14可操作地接合的信号到柄部组件14中的控制器(诸如控制器),并且/或者在可互换轴组件200与柄部组件14之间传导功率和/或通信信号。例如,可互换轴组件200可包括可操作地安装到轴电路板610的电连接器1410。位于轴上的电连接器1410被构造成能够与位于柄部中的电路板100上的电连接器1400配合接合。重新获得电路和控制系统的更多细节可见于美国专利申请公开2014/0263541。第五系统可由用于可释放地将可互换轴组件200锁定到柄部组件14的闩锁系统组成。
参见图14,示出了端部执行器300的非限制性形式。如上所述,端部执行器300可包括砧座306和外科钉仓304。在该非限制性示例中,砧座306联接到细长通道198。例如,孔199可限定在细长通道198中,该孔可接收从砧座306延伸的销152并允许砧座306相对于细长通道198和外科钉仓304从打开位置枢转到闭合位置。此外,图14示出了被构造成能够纵向平移到端部执行器300内的击发杆172。击发杆172可由一个实心部分构成,或在各种示例中,可包括层合材料,该层合材料包括例如一叠钢板。击发杆172的远侧突出端可附接到E型横梁178,该E型横梁可(除了其它以外)在砧座306处于闭合位置时有助于将砧座306与定位在细长通道198中的外科钉仓304间隔开。E型横梁178还可包括锋利切割边缘182,当通过击发杆172向远侧推进E型横梁178时,该切割边缘可用于切断组织。在操作中,E型横梁178还可致动或击发外科钉仓304。外科钉仓304可包括模塑的仓体194,该仓体保持多个钉191,这些多个钉安置在钉驱动器192上,这些钉驱动器位于分别向上打开的钉腔195中。楔形滑动件190通过E形横梁178朝远侧驱动,从而在仓托盘196上滑动,该仓托盘将外科钉仓304的各种部件保持在一起。楔形滑动件190使钉驱动器192向上进行凸轮运动,以将钉191挤出成与砧座306变形接触,同时E形横梁178的切割边缘182切断夹紧的组织。
除上述之外,E形横梁178可包括在击发期间接合砧座306的上部销180。E形横梁178还可包括中间销184和底脚186,其可接合仓体194、仓托盘196和细长通道198的各个部分。当外科钉仓304定位在细长通道198内时,限定在仓体194中的狭槽193可与限定在仓托盘196中的纵向狭槽197以及限定在细长通道198中的狭槽189对齐。在使用中,E型横梁178可滑动穿过对齐的纵向狭槽193、197和189,如图14所示,其中E型横梁178的底脚186可沿狭槽189的长度接合沿细长通道198的底面延伸的沟槽,中间销184可沿纵向狭槽197的长度接合仓托盘196的顶部表面,并且上部销180可接合砧座306。在这种情况下,当击发杆172向远侧运动以从外科钉仓304击发钉和/或切入砧座306和外科钉仓304之间捕集的组织时,E型横梁178可分开或限制砧座306和外科钉仓304之间的相对运动。然后,击发杆172和E形横梁178可朝近侧回缩,从而允许砧座306被打开,以释放两个缝合和切割的组织部分(未示出)。
现已概括地描述了外科器械10(图1至图14),下面将详细描述外科器械10的各种电力/电子部件。再次参见图2和图3,柄部组件14可包括电连接器1400,该电连接器包括多个电触点。现在转到图15,电连接器1400可包括例如第一电触点1401a、第二电触点1401b、第三电触点1401c、第四电触点1401d、第五电触点1401e和第六电触点1401f。尽管所示的示例利用了六个触点,但是设想了可利用多于六个触点或少于六个触点的其它示例。
如图15所示,第一电触点1401a可与晶体管1408电连通,电触点1401b-1401e可与控制器1500电连通,并且第六电触点1401f可与地电连通。在某些情况下,电触点1401b-1401e中的一个或多个可与控制器1500的一个或多个输出通道电连通,并且在柄部1042处于加电状态时可通电,或具有施加到其的电压电位。在一些情况下,电触点1401b-1401e中的一个或多个可与控制器1500的一个或多个输入通道电连通,并且当柄部组件14处于加电状态时,控制器1500可被配置成能够检测电压电位何时被施加到此类电触点。当轴组件(诸如可互换轴组件200)装配到柄部组件14时,电触点1401a-1401f可不彼此连通。然而,当轴组件未装配到柄部组件14时,电连接器1400的电触点1401a-1401f可暴露,并且在一些情况下,电触点1401a-1401f中的一个或多个可意外地布置成彼此电连通。例如,当电触点1401a-1401f中的一个或多个接触导电材料时,可出现此类情况。当发生这种情况时,例如,控制器1500可接收到错误的输入并且/或者可互换轴组件200可接收到错误的输出。为解决这个问题,在各种情况下,当轴组件(诸如可互换轴组件200)未附接到柄部组件14时,柄部组件14可以不加电。
在其它情况下,柄部1042可在轴组件诸如可互换轴组件200未附接到该柄部时加电。在这种情况下,例如,控制器1500可被配置成能够忽视施加到与控制器1500电连通的触点(即,电触点1401b-1401e)的输入或电压电位,直到轴组件附接到柄部组件14。即使在此类情况下控制器1500可提供有用于操作柄部组件14的其它功能的功率,柄部组件14也可处于掉电状态。在某种程度上,电连接器1400可处于掉电状态,因为施加到电触点1401b-1401e的电压电位可能不影响柄部组件14的操作。读者将会知道,即使电触点1401b-1401e可处于掉电状态,但未与控制器1500电连通的电触点1401a和1401f可处于或可不处于掉电状态。例如,无论柄部组件14是处于加电还是掉电状态,第六电触点1401f均可保持与地电连通。
此外,无论柄部组件14是处于加电还是掉电状态,晶体管1408和/或晶体管的任何其它合适结构(诸如晶体管1412)和/或开关可被配置成能够控制从柄部组件14内的电源1404(诸如电池)例如到第一电触点1401a的功率供应。在各种情况下,例如,当可互换轴组件200与柄部组件14接合时,可互换轴组件200可被配置成能够改变晶体管1408的状态。在某些情况下,除下述之外,磁场传感器1402可被配置成能够转换晶体管1412的状态,因此可转换晶体管1408的状态,最终将来自功率源1404的功率供应给第一电触点1401a。这样,联接到电连接器1400的功率电路和信号电路两者当轴组件未安装到柄部组件14时可被掉电,并且当轴组件安装到柄部组件14时可被加电。
在各种情况下,再次参见图15,柄部组件14可包括例如磁场传感器1402,当轴组件联接到柄部组件14时,该磁场传感器可被配置成能够检测位于该轴组件(诸如可互换轴组件200)上的可检测元件,诸如磁性元件1407(图3)。磁场传感器1402可由诸如电池之类的功率源1406供电,该功率源实际上可放大磁场传感器1402的检测信号,并经由图15所示的电路与控制器1500的输入通道通信。一旦控制器1500接收到指示轴组件已至少部分地联接到柄部组件14、因而电触点1401a-1401f不再暴露的输入,控制器1500就可进入其正常的或加电的操作状态。在此类工作状态中,控制器1500将对从轴组件传输到一个或多个电触点1401b-1401e的信号进行评估,和/或通过处于其正常使用状态的一个或多个电触点1401b-1401e将信号传输到轴组件。在各种情况下,在磁场传感器1402可检测到磁性元件1407之前,可能必须使可互换轴组件200完全坐置。例如,虽然可利用磁场传感器1402来检测轴组件200是否存在,但也可利用传感器和/或开关的任何合适的系统来检测可互换轴组件是否已装配到柄部组件14。这样,除上述之外,联接到电连接器1400的功率电路和信号电路两者当轴组件未安装到柄部组件14时可被掉电,并且当轴组件安装到柄部组件14时可被加电。
在各种示例中,如贯穿本公开可能使用的,例如,可采用任何合适的磁场传感器来检测轴组件是否已装配到柄部组件14。例如,用于磁场感测的技术包括霍尔效应传感器、探测线圈、磁通门、光泵、核旋、SQUID(超导量子干涉仪—一种非常灵敏的磁力计,用于测量非常微小的磁场,基于含有约瑟夫逊结的超导环)、霍尔效应、各向异性磁电阻、巨磁电阻、磁性隧道结、巨磁阻抗、磁致伸缩/压电复合材料、磁敏二极管、磁敏晶体管、光纤、磁光,以及基于微机电系统的磁性传感器等。
参见图15,控制器1500通常可包括处理器(“微处理器”)和可操作地联接到该处理器的一个或多个存储器单元。处理器通过执行存储器中存储的指令码可控制外科器械的各种部件,诸如马达、各种驱动系统和/或用户显示器。控制器1500可使用集成的和/或离散的硬件元件、软件元件和/或它们的组合来实现。集成硬件元件的示例可包括处理器、微处理器、微控制器、控制器、集成电路、专用集成电路(ASIC)、可编程逻辑器件(PLD)、数字信号处理器(DSP)、现场可编程门阵列(FPGA)、逻辑门、寄存器、半导体器件、芯片、微芯片、芯片组、控制器、片上系统(SoC)和/或封装系统(SIP)。分立硬件元件的示例可包括电路和/或电路元件,诸如逻辑门、场效应晶体管、双极型晶体管、电阻器、电容器、电感器和/或继电器。在某些情况下,例如,控制器1500可包括混合电路,该混合电路在一个或多个基板上包括分立的和集成的电路元件或部件。
参见图15,控制器1500可为例如购自Texas Instruments的LM4F230H5QR。在某些情况下,Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核包括高达40MHz的256KB单周期闪速存储器或其它非易失性存储器的芯片上存储器、40MHz以上的用于提高性能的预取缓冲区、32KB单周期串行随机存取存储器(SRAM)、加载有软件的内置只读存储器(ROM)、2KB电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、一个或多个具有12个模拟输入通道的12位模/数转换器(ADC)、以及从产品数据表易得的其它特征结构。可以很方便地换用其它控制器,来与本公开联合使用。因此,本公开不应限于这一上下文。
如上文所讨论,当可互换轴组件200未装配到或未完全装配到柄部组件14时,柄部组件14和/或轴组件200可包括下述系统和构型,以被配置成能够防止或至少降低位于柄部的电连接器1400的触点和/或位于轴的电连接器1410的触点发生短路的可能性。参见图3,位于柄部的电连接器1400可至少部分地陷入框架20中限定的腔体1409内。电连接器1400的六个电触点1401a-1401f可完全陷入腔体1409内。此类构造可降低物体意外地接触电触点1401a-1401f中的一个或多个的可能性。相似地,位于轴上的电连接器1410可以定位在底座240中限定的凹陷部内,这可以降低物体意外接触位于轴上的电连接器1410的一个或多个电触点1411a-1411f的可能性。参照图3中描绘的具体示例,位于轴上的电触点1411a-1411f可包括凸形触点。在至少一个示例中,位于轴中的每个电触点1411a-1411f可包括从其延伸的柔性突出部,该柔性突出部可被构造成能够接合例如位于柄部上的电触点1401a-1401f。位于柄部上的电触点1401a-1401f可包括凹形触点。在至少一个示例中,每个位于柄部的电触点1401a-1401f可包括平坦表面,例如,位于轴中的凸形电触点1401a-1401f可抵靠该平坦表面擦过或滑过,从而维持其间的导电接合。在各种情况下,将可互换轴组件200装配到柄部组件14的方向可平行于、或至少基本上平行于位于柄部的电触点1401a-1401f,使得在将可互换轴组件200装配到柄部组件14时,位于轴中的电触点1411a-1411f抵靠电触点1401a-1401f滑动。在各种替代示例中,位于柄部的电触点1401a至1401f可包括凸形触点,位于轴中的电触点1411a至1411f可包括凹形触点。在某些替代示例中,位于柄部的电触点1401a至1401f和位于轴中的电触点1411a至1411f可具有任何合适的触点构造方式。
在各种情况下,柄部组件14可包括被构造成能够至少部分地覆盖位于柄部上的电连接器1400连接器防护件,以及/或者被构造成至少部分地覆盖位于轴上的电连接器1410的连接器防护件。当轴组件未装配到、或只部分地装配到柄部时,连接器防护件可防止、或至少降低物体意外地接触电连接器的触点的可能性。连接器防护件可以是可动的。例如,连接器防护件可在防护位置与非防护位置之间运动,在防护位置,该连接器防护件至少部分地保护连接器,在非防护位置,该连接器防护件不保护连接器,或至少为连接器提供较少保护。在至少一个示例中,将轴组件装配到柄部时,连接器防护件的位置可被移置。例如,如果柄部包括柄部连接器防护件,则在将轴组件装配到柄部时,轴组件可接触并移置柄部连接器防护件。相似地,如果轴组件包括轴连接器防护件,则在将轴组件装配到柄部时,柄部可接触并移置轴连接器防护件。在各种情况下,例如,连接器防护件可包括门。在至少一种情况下,该门可包括倾斜表面,在门与柄部或轴接触时,该倾斜表面可有利于门沿确定方向的位移。在各种情况下,例如,连接器防护件可被平移和/或旋转。在某些情况下,连接器防护件可包括覆盖电连接器触点的至少一层膜。当将轴组件装配到柄部时,这层膜可能破裂。在至少一种情况下,连接器的凸形触点可先刺透这层膜,再与定位在这层膜下方的对应触点接合。
如上所述,外科器械可包括能够选择性地对电连接器(诸如电连接器1400)的触点进行加电或启动的系统。在各种情况下,触点可在未激活状况与激活状况之间转换。在某些情况下,触点可在监控状况、去激活状况与激活状况之间转换。例如,当轴组件尚未装配到柄部组件14时,控制器1500例如可监测电触点1401a-1401f,以确定电触点1401a-1401f中的一个或多个是否可能已经短路。控制器1500可被配置成能够将低电压电位施加到电触点1401a-1401f中的每个,并评估在该电触点中的每个处是否仅存在最小电阻。此操作状态可包括监控状况。如果在某个触点处检测到的电阻很高,或超过了阈值电阻,则控制器1500可去激活该触点、多于一个触点,或者全部触点。此操作状态可包括去停用状况。如上文所讨论,如果轴组件装配到柄部组件14,并被控制器1500检测到,则控制器1500可提高施加到电触点1401a-1401f的电压电位。此操作状态可包括启动状况。
本文所公开的各种轴组件可采用传感器和各种其它部件,所述传感器和各种其它部件需要与外壳中的控制器电连通。这些轴组件通常被配置成能够相对于外壳旋转,因此必须在两个或更多个可相对彼此旋转的部件之间设置有利于这种电连通的连接件。当采用本文所公开类型的端部执行器时,连接器布置在本质上必须相对稳固,同时还必须略微紧凑,以装配到轴组件的连接器部分中。
现在转到图16A和图16B,其中示出了包括多个电路段2002a-2002g的分段电路2000的一个示例。分段电路2000包括多个电路段2002a至2002g,该分段电路被配置成能够控制加电外科器械,诸如但不限于图1至图13中所示的外科器械10。多个电路段2002a-2002g被配置成能够控制加电外科器械10的一种或多种操作。安全处理器段2002a(第1段)包括安全处理器2004。主处理器段2002b(第2段)包括主处理器2006。安全处理器2004和/或主处理器2006被配置成能够与一个或多个附加的电路段2002c-2002g进行交互,以控制加电外科器械10的操作。主处理器2006包括联接到例如一个或多个电路段2002c-2002g、电池2008和/或多个开关2058a-2070的多个输入装置。分段电路2000可通过任何合适的电路(诸如加电外科器械10内的印刷电路板组件(PCBA))来实施。应当理解,本文使用的术语“处理器”包括任一种微处理器、处理器、微控制器、控制器,或者将计算机的中央处理单元(CPU)的功能结合到一个集成电路或最多几个集成电路上的其它基础计算装置。处理器是多用途的可编程装置,该装置接收数字数据作为输入,依据其存储器中存储的指令来处理输入,然后提供结果作为输出。因为处理器具有内部存储器,所以是顺序数字逻辑的示例。处理器的操作对象是以二进制数字系统表示的数字和符号。
在一个方面,主处理器2006可以是任一种单核或多核处理器,诸如已知的由TexasInstruments生产的商品名为ARM Cortex的那些。在一个示例中,安全处理器2004可以是包括两个基于控制器的系列(诸如TMS570和RM4x)的安全控制器平台,已知同样由TexasInstruments生产的商品名为Hercules ARM Cortex R4。然而,可不受限制地采用控制器和安全处理器的其它合适的替代物。在一个示例中,安全处理器2004可具体地针对IEC 61508和ISO 26262安全关键应用程序等等进行构造,以在输送可量化的性能、连通性和存储选项时提供高级集成安全特征。在某些情况下,主处理器2006可以是如结合图14至图17B所述的单核或多核控制器LM4F230H5QR。
在一个方面,分段电路2000包括加速度段2002c(第3段)。该加速度段2002c包括加速度计2022。加速度计2022被配置成能够检测加电外科器械10的运动或加速度。在一些示例中,来自加速度计2022的输入用于例如转变到休眠模式和从休眠模式转变到其它模式、识别加电外科器械的取向,并且/或者识别外科器械何时已被放下。在一些示例中,加速度段2002c联接到安全处理器2004和/或主处理器2006。
在一个方面,分段电路2000包括显示器段2002d(第4段)。显示器段2002d包括联接到主处理器2006的显示器连接器2024。显示器连接器2024通过显示器2026的一个或多个集成电路驱动器将主处理器2006联接到显示器2028。显示器的集成电路驱动器2026可与显示器2028集成,和/或可与显示器2028分开定位。显示器2028可包括任一种合适的显示器,诸如有机发光二极管(OLED)显示器、液晶显示器(LCD)和/或其它任何合适的显示器。在一些示例中,显示器段2002d联接到安全处理器2004。
在一些方面中,分段电路2000包括轴段2002e(第5段)。轴段2002e包括用于联接到外科器械10的可互换轴组件200(图1)的一个或多个控件,以及/或者用于联接到可互换轴组件200(图1)的端部执行器300的一个或多个控件。轴段2002e包括轴连接器2030,该轴连接器被配置成能够将主处理器2006联接到轴PCBA 2031。轴PCBA 2031包括第一关节运动开关2036、第二关节运动开关2032、和轴PCBA EEPROM 2034。在一些示例中,轴PCBA EEPROM2034包括特定于可互换轴组件200和/或轴PCBA 2031的一个或多个参数、例程和/或程序。轴PCBA 2031可联接到可互换轴组件200和/或与外科器械10一体成型。在一些示例中,轴段2002e包括第二轴EEPROM 2038。第二轴EEPROM 2038包括对应于可与加电外科器械10交接的一个或多个轴组件200和/或端部执行器300的多个算法、例程、参数、和/或其它数据。
在一些方面中,分段电路2000包括位置编码器段2002f(第6段)。位置编码器段2002f包括一个或多个磁性角旋转位置编码器2040a-2040b。一个或多个磁性角旋转位置编码器2040a-2040b被配置成能够识别外科器械10的马达2048、可互换轴组件200(图1)和/或端部执行器300的旋转位置。在一些示例中,磁性角旋转位置编码器2040a-2040b可联接到安全处理器2004和/或主处理器2006。
在一些方面中,分段电路2000包括马达电路段2002g(第7段)。马达电路段2002g包括马达2048,该马达被配置成能够控制加电外科器械10的一种或多种运动。马达2048通过H-桥驱动器2042和一个或多个H-桥场效应晶体管2044(FET)联接到主处理器2006。H-桥FET2044联接到安全处理器2004。马达电流传感器2046与马达2048串联联接,用于测量马达2048的电流消耗。马达电流传感器2046与主处理器2006和/或安全处理器2004进行信号通信。在一些示例中,马达2048联接到马达电磁干扰(EMI)滤波器2050。
在一些实施方案中,分段电路2000包括功率段2002h(第8段)。电池2008联接到安全处理器2004、主处理器2006,以及附加的电路段2002c-2002g中的一个或多个。电池2008通过电池连接器2010和电流传感器2012联接到分段电路2000。电流传感器2012被配置成能够测量分段电路2000的总电流消耗。在一些示例中,一个或多个电压转换器2014a、2014b、2016被配置成能够向一个或多个电路段2002a-2002g提供预先确定的电压值。例如,在一些示例中,分段电路2000可包括3.3V的电压转换器2014a-2014b和/或5V的电压转换器2016。升压转换器2018被配置成能够提供最高为预先确定的量(诸如,最高至13V)的升压电压。升压转换器2018被配置成能够在功率密集操作期间提供附加的电压和/或电流,并且能够防止电压降低状况或低功率状况。
在一些方面中,安全处理器段2002a包括马达功率开关2020。马达功率开关2020联接在功率段2002h与马达电路段2002g之间。安全处理器段2002a被配置成能够在安全处理器2004和/或主处理器2006检测到错误或故障状况时中断到马达电路段2002g的功率,如本文更详细地讨论。尽管电路段2002a-2002g被示为具有电路段2002a-2002h中物理位置接近的所有部件,但本领域的技术人员将认识到,电路段2002a-2002h可包括在物理上和/或在电学上与相同电路段2002a-2002g的部件分开的其它部件。在一些示例中,一个或多个部件可由两个或多个电路段2002a-2002g共享。
在一些示例中,多个开关2056-2070联接到安全处理器2004和/或主处理器2006。多个开关2056-2070可被配置成能够控制外科器械10的一种或多种操作、能够控制分段电路2000的一种或多种操作,和/或能够指示外科器械10的状态。例如,应急门开关2056被配置成能够指示应急门的状态。多个关节运动开关(诸如左侧向左关节运动开关2058a、左侧向右关节运动开关2060a、左侧向中心关节运动开关2062a、右侧向左关节运动开关2058b、右侧向右关节运动开关2060b和右侧向中心关节运动开关2062b)被配置成能够控制轴组件200和/或端部执行器300的关节运动。左侧换向开关2064a和右侧换向开关2064b联接到主处理器2006。在一些示例中,左侧开关(包括左侧向左关节运动开关2058a、左侧向右关节运动开关2060a、左侧向中心关节运动开关2062a和左侧换向开关2064a)通过左挠性连接器2072a联接到主处理器2006。右侧开关(包括右侧向左关节运动开关2058b、右侧向右关节运动开关2060b、右侧向中心关节运动开关2062b和右侧换向开关2064b)通过右挠性连接器2072b联接到主处理器2006。在一些示例中,击发开关2066、夹持释放开关2068和轴接合开关2070联接到主处理器2006。
在一些方面,多个开关2056-2070可包括例如安装到外科器械10的柄部的多个柄部控件、多个指示器开关、和/或它们的任何组合。在各种示例中,多个开关2056-2070允许外科医生操纵外科器械,向分段电路2000提供有关外科器械的位置和/或操作的反馈,并且/或者指示外科器械10的不安全操作。在一些示例中,附加的或更少的开关可联接到分段电路2000,开关2056-2070中的一个或多个可组合成单个开关,并/或扩展成多个开关。例如,在一个示例中,左侧关节运动开关和/或右侧关节运动开关2058a-2064b中的一个或多个可组合成单个多位置开关。
在一个方面,安全处理器2004被配置成能够除了其它的安全操作以外实现看门狗功能。分段电路2000的安全处理器2004和主处理器2006进行信号通信。处理器活心跳信号在输出端2097处提供。加速度段2002c包括加速度计2022,该加速度计被配置成能够监控外科器械10的运动。在各种示例中,加速度计2022可以是单轴、双轴或三轴加速度计。加速度计2022可用于测量适当的加速度,该加速度不一定是坐标加速度(速度改变的速率)。作为替代,加速度计观察到在加速度计2022的参照系静止时,与测试质量经受的重量现象相关联的加速度。例如,在地球的表面上静止的加速度计2022由于其重量将测量竖直向上的(重力)加速度g=9.8m/s2。加速度计2022可测量的另一类加速度是重力加速度。在各种其它示例中,加速度计2022可包括单轴、双轴或三轴加速度计。此外,加速度段2002c可包括一个或多个惯性传感器,以检测和测量加速度、倾斜、冲击、振动、旋转和多自由度(DoF)。合适的惯性传感器可包括加速度计(单轴、双轴或三轴)、用于测量空间磁场(诸如地球磁场)的磁力计和/或用于测量角速度的陀螺仪。
在一个方面,安全处理器2004被配置成能够针对一个或多个电路段2002c-2002h(诸如马达电路段2002g)实现看门狗功能。就这一点来说,安全处理器2004采用看门狗功能来检测主处理器2006的故障并从主处理器2006的故障中恢复。在正常操作期间,安全处理器2004监视主处理器2006的硬件故障或程序错误,并发起一种或多种纠正行动。纠正行动可包括将主处理器2006置于安全状态,并恢复正常的系统操作。在一个示例中,安全处理器2004至少联接到第一传感器。第一传感器测量外科器械10(图1至图4)的第一性质。在一些示例中,安全处理器2004被配置成能够将外科器械10的所测量性质与预先确定的值进行比较。例如,在一个示例中,磁性角旋转位置编码器2040a联接到安全处理器2004。磁性角旋转位置编码器2040a向安全处理器2004提供马达的速度和位置信息。安全处理器2004监视磁性角旋转位置编码器2040a并将值与最大速度和/或位置值进行比较,并且如果值高于预先确定的值,则阻止马达2048的操作。在一些示例中,预定值基于马达2048的实时速度和/或位置计算、由与主处理器2006通信的第二磁性角旋转位置编码器2040b提供的值计算,并且/或者从例如联接到安全处理器2004的存储器模块提供给安全处理器2004。
在一些方面,第二传感器联接到主处理器2006。第二传感器被配置成能够测量第一物理性质。安全处理器2004和主处理器2006被配置成能够提供分别表征第一传感器的值和第二传感器的值的信号。当安全处理器2004或主处理器2006指示值超出可接受范围时,分段电路2000便阻止电路段2002c-2002h中至少一个(诸如马达电路段2002g)的操作。例如,在图16A和图16B所示的示例中,安全处理器2004联接到第一磁性角旋转位置编码器2040a,并且主处理器2006联接到第二磁性角旋转位置编码器2040b。磁性角旋转位置编码器2040a、2040b可包括任何合适的马达位置传感器,诸如,具有正弦和余弦输出的磁性角度旋转输入装置。磁性角旋转位置编码器2040a、2040b向安全处理器2004和主处理器2006提供指示马达2048的位置的相应的信号。
当第一磁性角旋转位置编码器2040a的值和第二磁性角旋转位置编码器2040b的值处于预定范围内时,安全处理器2004和主处理器2006便生成启动信号。当主处理器2006或安全处理器2004检测到值超出预定范围时,则终止启动信号,随即中断并/或阻止至少电路段2002c-2002h(诸如马达电路段2002g)中的一个的操作。例如,在一些示例中,来自主处理器2006的激活信号和来自安全处理器2004的激活信号联接到AND栅极。AND栅极联接到马达功率开关2020。当来自安全处理器2004和主处理器2006这两者的激活信号都较高(指示磁性角旋转位置编码器2040a、2040b的值在预先确定的范围内)时,AND栅极便将马达功率开关2020保持在闭合或打开位置。当磁性角旋转位置编码器2040a、2040b中任一者检测到值超出预先确定的范围时,则来自磁性角旋转位置编码器2040a、2040b的激活信号被设定为低,并且AND栅极的输出也被设定为低,从而断开马达功率开关2020。在一些示例中,比较了第一磁性角旋转位置编码器2040a的值与第二磁性角旋转位置编码器2040b的值,例如通过安全处理器2004和/或主处理器2006进行比较。当第一传感器的值与第二传感器的值不同时,安全处理器2004和/或主处理器2006便可阻止马达电路段2002g的操作。
在一些方面,安全处理器2004接收指示第二磁性角旋转位置编码器2040b的值的信号,并且将第二传感器的值与第一传感器的值进行比较。例如,在一个方面,安全处理器2004直接联接到第一磁性角旋转位置编码器2040a。第二磁性角旋转位置编码器2040b联接到主处理器2006(该主处理器将第二磁性角旋转位置编码器2040b的值提供给安全处理器2004)并且/或者直接联接到安全处理器2004。安全处理器2004将第一磁性角旋转位置编码器2040的值与第二磁性角旋转位置编码器2040b的值进行比较。当安全处理器2004检测到第一磁性角旋转位置编码器2040a与第二磁性角旋转位置编码器2040b之间存在失配时,安全处理器2004可例如通过切断到马达电路段2002g的功率来中断马达回路段2002g的操作。
在一些方面,安全处理器2004和/或主处理器2006联接到被配置成能够测量外科器械的第一性质的第一磁性角旋转位置编码器2040a和被配置成能够测量外科器械的第二性质的第二磁性角旋转位置编码器2040b。第一性质和第二性质包括外科器械正常操作时的预先确定的关系。安全处理器2004监视第一性质和第二性质。当检测到第一性质的值和/或第二性质的值与预先确定的关系不一致时,则发生故障。发生故障时,安全处理器2004至少采取一种行动,诸如,阻止电路段中的至少一个的操作、执行预先确定的操作,和/或重置主处理器2006。例如,安全处理器2004在检测到故障时可断开马达功率开关2020,以切断到马达电路段2002g的功率。
在一个方面,安全处理器2004被配置成能够执行独立的控制算法。在操作中,安全处理器2004监控分段电路2000并且被配置成能够独立地控制和/或覆写来自其它电路部件诸如主处理器2006的信号。安全处理器2004可执行预先编程的算法并且/或者在操作期间可基于外科器械10的一种或多种行动和/或位置进行联机更新或联机编程。例如,在一个示例中,每当新的轴和/或端部执行器联接到外科器械10时,便使用新的参数和/或安全算法对安全处理器2004进行重新编程。在一些示例中,安全处理器2004存储的一个或多个安全值由主处理器2006复制。执行双向错误检测,以确保安全处理器2004或主处理器2006存储的值和/或参数是正确的。
在一些方面,安全处理器2004和主处理器2006实施冗余的安全检查。安全处理器2004和主处理器2006提供周期性信号,用于指示操作正常。例如,在操作期间,安全处理器2004可向主处理器2006指示安全处理器2004正在执行代码并且操作正常。主处理器2006同样可向安全处理器2004指示主处理器2006正在执行代码并且操作正常。在一些示例中,安全处理器2004和主处理器2006以预先确定的间隔通信。预先确定的间隔可以是常数,也可能可依据电路状态和/或外科器械10的操作而改变。
图17A和图17B示出了被配置成能够控制图1至图14所示的电动外科器械10的分段电路3000的另一方面。如图14、图17B所示,柄部组件14可包括电动马达3014,该电动马达可由马达驱动器3015控制,并可由外科器械10的击发系统使用。在各种形式中,电动马达3014例如可以是具有约25,000RPM的最大旋转的直流有刷驱动马达。在其它构造中,电动马达3014可包括无刷马达、无绳马达、同步马达、步进马达或任何其它合适的电动马达。在某些情况下,马达驱动器3015可包括例如H-Bridge FETs 3019,如图17A和图17B所示。电动马达3014可由功率组件3006供电,该功率组件可以可释放地安装到柄部组件14。功率组件3006被配置成能够向外科器械10供应控制功率。功率组件3006可包括电池,该电池可包括串联连接的、可用作功率源为外科器械10供电的多个电池单元。在这种构型中,功率组件3006可被称为电池组。在某些情况下,功率组件3006的电池单元可以是可替换的和/或可再充电的。在至少一个示例中,电池单元可以是能够可分离地联接到功率组件3006的锂离子电池。
适合与外科器械10一起使用的驱动系统和闭合系统的示例公开于名称为“CONTROL SYSTEM OF A SURGICAL INSTRUMENT”的美国专利申请公开2014/0263539,该专利申请的公开内容全文以引用方式并入本文。例如,电动马达3014可包括与齿轮减速器组件可操作地连接的可旋转轴(未示出),该齿轮减速器组件可与一组或一齿条的驱动齿啮合接合地安装在可纵向移动的驱动构件上。在使用中,电池所提供的电压极性可操作电动马达3014驱动可纵向移动的驱动构件,以使端部执行器300生效。例如,电动马达3014可被配置成能够驱动能够纵向移动的驱动构件以推进击发机构,从而将钉从与端部执行器300装配在一起的钉仓击发到由端部执行器300捕集的组织中,和/或推进切割构件来例如切割由端部执行器300捕集的组织。
如图17A和图17B所示,并如下文更详细地描述,例如,功率组件3006可包括功率管理控制器,该功率管理控制器可被配置成能够调节功率组件3006的功率输出,以便当可互换轴组件200联接到柄部组件14(图1)时,输送第一功率输出为电动马达3014供电,从而将切割构件推进,并且以便当可互换轴组件200联接到柄部组件14时,输送第二功率输出为电动马达3014供电,从而将切割构件推进。这种调节在避免将超出联接到柄部组件14的可互换轴组件需求的过高功率传输到电动马达3014这方面可以是有利的。
在某些情况下,例如,通过将一个或多个通信信号路由通过位于柄部组件14(图1)中的主控制器3017,接口3024可有利于在功率管理控制器3016与轴组件控制器3022之间传输这类通信信号。在其它情况下,当可互换轴组件200(图1)和功率组件3006联接到柄部组件14时,接口3024可有利于通过柄部组件14的功率管理控制器3016和轴组件控制器3022之间的直接通信线路。
在一种情况下,主控制器3017可以是任何单核或多核处理器,诸如由TexasInstruments提供的以商品名ARM Cortex知名的那些处理器。在一种情况下,外科器械10(图1至图4)可包括功率管理控制器3016,例如包括两个基于控制器的系列(诸如TMS570和RM4x)的安全控制器平台(已知同样由Texas Instruments生产的商品名为Hercules ARMCortex R4)。然而,可不受限制地采用控制器和安全处理器的其它合适的替代物。在一种情况下,安全处理器2004(图16a)可具体地针对IEC 61508和ISO 26262安全关键应用程序等等进行构造,以在输送可量化的性能、连通性和存储选项时提供高级集成安全特征。
在某些情况下,主控制器3017可以是如结合图15至图17B所述的单核或多核控制器LM4F230H5QR。
图18为图1的外科器械的框图,其中示出柄部组件14(图1)与功率组件之间、以及柄部组件14与可互换轴组件之间的接口。如图18所示,功率组件3006可包括功率管理电路3034,该功率管理电路可包括功率管理控制器3016、功率调制器3038和电流感测电路3036。功率管理电路3034可被配置成能够在可互换轴组件200与功率组件3006联接到柄部组件14时,基于可互换轴组件200(图1)的功率要求调节电池3007的功率输出。例如,功率管理控制器3016可被编程以控制功率调制器3038调节功率组件3006的功率输出,电流感测电路3036可用于监视功率组件3006的功率输出,以便为功率管理控制器3016提供与电池3007的功率输出有关的反馈,使得功率管理控制器3016可调节功率组件3006的功率输出以维持理想的输出。
值得注意的是,功率管理控制器3016和/或轴组件控制器3022各自可包括一个或多个可存储多个软件模块的处理器和/或存储器单元。尽管可以举例的方式描述外科器械10(图1)的某些模块和/或区块,但可以理解,可使用更多或更少数目的模块和/或区块。此外,虽然各种情况可根据模块和/或块的形式描述以便于说明,但这些模块和/或块可通过一个或多个硬件部件(例如处理器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、专用集成电路(ASIC)、电路、寄存器)和/或软件部件(例如程序、子例程、逻辑)、和/或硬件部件与软件部件的组合加以实施。
在某些情况下,外科器械10(图1至图4)可包括输出装置3042,该输出装置可包括一个或多个用于向用户提供感官反馈的装置。此类装置可包括例如视觉反馈装置(例如,LCD显示屏、LED指示器)、听觉反馈装置(例如,扬声器、蜂鸣器)或触觉反馈装置(例如,触觉致动器)。在某些情况下,输出装置3042可包括显示器3043,该显示器可包含在柄部组件14(图1)中。轴组件控制器3022和/或功率管理控制器3016可通过输出装置3042向外科器械10的用户提供反馈。接口3024可被配置成能够将轴组件控制器3022和/或功率管理控制器3016连接到输出装置3042。读者将会知道,作为替代,输出装置3042可与功率组件3006集成。在这类情况下,当可互换轴组件200联接到柄部组件14时,输出装置3042与轴组件控制器3022之间的通信可通过接口3024实现。
已经描述了用于控制其操作的外科器械10(图1至图4)以及一个或多个分段电路2000、3000,本公开现在转向外科器械10和分段电路2000(或3000)的各种特定构型。
在各个方面,本公开提供了用于数据存储和使用的技术。在一个方面,数据存储和使用基于多级行动阈值。此类阈值包括上限和下限极限阈值限制,闭合马达或启动返回的极限阈值是电流、压力、击发负载、超过扭矩,另选地,当在限制内运行时,装置自动补偿马达的负载。
在一个方面,外科器械10(结合图1至图18描述)可以被配置成能够监测上限和下限极限阈值,以将最小和最大闭合夹持负载保持在可接受的限度内。如果未达到最小值,则外科器械10不能启动或者如果其下降到最小值以下,则需要用户行动。如果夹持负载处于合适的水平但在击发期间下降到最小,则外科器械10可以调整马达的速度或警告使用者。如果在操作期间违反了最低限制,则该单元可以发出警告,该警告可能不完全根据预期进行。外科器械10还可以被配置成能够监测电池电压何时下降到低于下限极限,剩余电池电力仅直接能够使装置返回到I型梁停放状态。可采用砧座上的打开力感测端部执行器中的阻塞。另选地,外科器械10可以被配置成能够监测马达电流何时上升或相关速度下降,然后马达控制增加脉宽或频率调制以保持速度恒定。
在另一方面,外科器械10可以(图1)被配置成能够检测电流消耗、压力、击发负载、扭矩的极限阈值,使得当超过这些阈值中的任何一个时,外科器械10闭合马达或使马达将刀返回到预先击发位置。可以采用小于极限阈值的第二阈值来改变马达控制程序以通过改变马达控制参数来适应条件的变化。边际阈值可以基于对另一个计数器或输入的成比例响应构造成阶跃函数或斜坡函数。例如,在消毒的情况下,在0-200个消毒周期之间没有变化,从201-400个消毒周期中每次使用1%的慢马达,并且防止使用超过400个消毒周期。马达的速度也可以基于组织间隙和电流消耗而变化。
存在许多参数可以影响电动可重复使用的缝合装置的理想功能。这些参数中的大多数具有极限最大和/或最小阈值,超过该阈值时不应操作该装置。然而,也存在可能影响装置功能操作的边际限制。多个参数的这些多个限制可以对装置的操作程序提供上覆和累积效应。
因此,本发明涉及外科器械,并且在各种情况下,涉及被设计成用于缝合和切割组织的外科缝合和切割器械及其钉仓。
机电装置的高效性能取决于各种因素。一个是操作包层,即装置执行其预期功能的参数、条件和事件的范围。例如,对于由电流驱动的马达供电装置,可能存在高于某个电流阈值的操作区域,其中该装置比期望的运行效率更低。换言之,可能存在一个上限“速度限制”,其上的效率会降低。此上阈值可以具有防止实质上低效或甚至装置退化的值。
然而,在操作包层内可能存在阈值,其可以形成可利用的区域以提高操作状态内的效率。换句话讲,可能存在装置可以在限定的操作包层(或子包层)内调整和执行的区域。此区域可以是边际阈值与极限阈值之间的区域。另外,这些区域可以包括“最有效点”或预先确定的任选范围或点。这些区域也可以包括大范围,在该范围内,性能被认为是足够的。
可以定义极限阈值,在该阈值之上或之下可以采取(或避免采取)一个或多个动作,诸如停止该装置。另外,可以定义边际阈值或阈值,在该边际阈值或阈值之上或之下可以采取(或避免采取)一个或多个动作。作为非限制性示例,可以设置边际阈值以定义马达的电流消耗超过极限阈值的75%的位置。例如,超过边际阈值可能导致装置开始以增加的速度减慢马达速度,因为它继续向极限阈值爬升。
可以采用各种机制来执行由于超过阈值而进行的调整。例如,调整可以反映阶跃函数。它还可以反映斜坡函数。可以利用其它功能。
在各个方面,为了通过附加机制来增强性能,可定义重叠阈值。重叠阈值可以包括由多个参数定义的一个或多个阈值。重叠阈值可导致一个或多个阈值是另一阈值或阈值的生成的输入。可以预先确定或动态地生成重叠阈值,例如在运行时。当阈值由多个输入定义时,重叠阈值可能会生效。例如,当消毒周期的数目超过300(边际阈值)但不超过500(极限阈值)时,装置使马达运行得更慢。然后当电流消耗超过其75%的边际阈值时,它会使减速倍数变得更慢。
图19示出了根据各种示例的用于评估外科器械10(图1至图4)的切割边缘182(图14)的锐度的系统4311的逻辑图。在某些情况下,系统4311可通过测试切割边缘182推进穿过锐度测试构件4302的能力来评估切割边缘182的锐度。例如,系统4311可被配置成能够观测切割边缘182完全横切和/或完全穿过锐度测试构件4302的至少预先确定的部分所需要的时间段。如果所观测的时间段超过预定义阈值,则电路4310可断定例如切割边缘182的锐度已下降到低于可接受水平。
在一个方面,锐度测试构件4302可用于测试切割边缘182的锐度(图14)。在某些情况下,锐度测试构件4302可例如附接到外科钉仓304(图1、图2和图15)的仓体194(图14)和/或与其形成一体。在某些情况下,锐度测试构件4302可设置在例如外科钉仓304的近侧部分中。在某些情况下,锐度测试构件4302可例如设置在外科钉仓304的仓平台或仓体194上。
在某些情况下,负荷单元4335可被配置成能够例如监控当切割边缘182(图14)接合和/或接触锐度测试构件4302时施加到切割边缘182的力(Fx)。读者将会知道,当切割刃182接合和/或接触锐度测试构件4302时由锐度测试构件4302施加到切割刃182的力(Fx)至少部分地取决于切割刃182的锐度。在某些情况下,切割边缘182的锐度的降低可导致切割边缘182切割或穿过锐度测试构件4302所需的力(Fx)增加。可以采用锐度测试构件4302的负荷单元4335测量施加到切割边缘182的力(Fx),同时切割边缘182通过锐度测试构件4302行进预定距离(D)可以用于确定切割边缘182的锐度。
在某些情况下,系统4311可包括控制器4313(“微控制器”),该控制器可包括处理器4315(“微处理器”)和一个或多个计算机可读介质或存储单元4317(“存储器”)。在某些情况下,存储器4317可存储各种程序指令,所述各种程序指令在执行时可使得处理器4315执行本文所述的多个功能和/或计算。在某些情况下,存储器4317可例如联接到处理器4315。电源4319可被配置成能够例如将功率供应给控制器4313。在某些情况下,电源4319可包括电池(或者“电池组”或“电源组”),例如,锂离子电池。在某些情况下,电池组可被构造成能够可释放地安装到柄部组件14。可将多个串联的电池单元用作电源4319。在某些情况下,电源4319可为例如可更换的和/或可再充电的。
在某些情况下,控制器4313可操作地联接到例如反馈系统和/或闭锁机构4123。
系统4311可包括一个或多个位置传感器。适合与本公开一起使用的示例位置传感器和定位系统在名称为“SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FORSURGICAL INSTRUMENTS”的美国专利申请序列公开2014/0263538中有所描述,该专利申请的公开内容全文以引用方式并入本文。在某些情况下,系统4311可包括第一位置传感器4321和第二位置传感器4323。在某些情况下,第一位置传感器4321可用于检测例如锐度测试构件4302的近侧端部处的切割边缘182(图14)的第一位置;并且第二位置传感器4323可用于检测例如锐度测试构件4302的远侧端部处的切割边缘182的第二位置。
在某些情况下,第一和第二位置传感器4321、4323可用于分别将第一位置信号和第二位置信号提供给控制器4313。应当理解,位置信号可为模拟信号或数字值,这取决于控制器4313与第一和第二位置传感器4321和4323之间的接口。在一个示例中,控制器4313与第一和第二位置传感器4321和4323之间的接口可为标准串行外围设备接口(SPI),并且位置信号可为表示切割边缘182的第一位置和第二位置的数字值,如上所述。
除上述之外,处理器4315可确定接收第一位置信号与接收第二位置信号之间的时间段。所确定的时间段可对应于切割边缘182(图14)从例如锐度测试构件4302的近侧端部处的第一位置到例如锐度测试构件4302的远侧端部处的第二位置推进穿过锐度测试构件4302所需要的时间。在至少一个示例中,控制器4313可包括时间元件,该时间元件可在接收到第一位置信号时由处理器4315启动并且可在接收到第二位置信号时停用。时间元件的启动和停用之间的时间段可对应于例如切割刃182从第一位置推进到第二位置所需要的时间。时间元件可包括实时时钟、被配置成能够实现计时功能的处理器、或任何其它合适的计时电路。
在各种情况下,控制器4313可例如将切割边缘182(图14)从第一位置推进到第二位置所需要的时间段与预定义阈值进行比较以评价切割边缘182的锐度是否已下降到低于可接受水平。在某些情况下,如果所测量的时间段超过预定义阈值例如1%、5%、10%、25%、50%、100%和/或多于100%,则控制器4313可断定切割边缘182的锐度已下降到低于可接受水平。
图20示出了根据各个方面的用于通过锐度测试构件4302在各种锐度水平下确定施加在外科器械10(图1至图4)的切割边缘上的力的系统4340的逻辑图。参见图20,在各种情况下,电动马达4331可驱动击发杆172(图20)以例如在击发行程期间推进切割边缘182(图14)并且/或者在返回行程期间回缩切割边缘182。马达驱动器4333可以控制电动马达4331;并且控制器(诸如,控制器4313)可以与马达驱动器4333进行信号通信。当电动马达4331推进切割边缘182时,控制器4313可例如确定由电动马达4331消耗的电流。在此类情况下,推进切割边缘182所需的力可对应于例如由电动马达4331消耗的电流。仍参见图20,外科器械10的控制器4313可确定切割边缘182的推进期间由电动马达4331消耗的电流是否增大,并且如果增大,则可计算电流的增量百分比。
在某些情况下,当切割边缘182(图14)与锐度测试构件4302接触时,由电动马达4331消耗的电流可因锐度测试构件4302对切割边缘182的阻力而显著增大。例如,当切割边缘182接合、穿过、和/或切穿锐度测试构件4302时,由电动马达4331消耗的电流可显著增大。读者将理解,锐度测试构件4302对切割边缘182的阻力部分地取决于切割边缘182的锐度;并且随着切割边缘182的锐度因重复使用而减小,锐度测试构件4302对切割边缘182的阻力将增加。因此,当切割边缘与锐度测试构件4302接触时由电动马达4331消耗的电流的增量百分比的值可例如随着切割边缘182的锐度因重复使用造成的降低而增大。
在某些情况下,所确定的由电动马达4331消耗的电流的增量百分比的值可为由电动马达4331消耗的电流的最大检测增量百分比。在各种情况下,控制器4313可将所确定的由电动马达4331消耗的电流的增量百分比的值与由电动马达4331消耗的电流的增量百分比的预定义阈值进行比较。如果所确定的值超过预定义阈值,则控制器4313可断定例如切割边缘182的锐度已下降到低于可接受水平。
在某些情况下,如图20所示,处理器4315可例如与反馈系统和/或闭锁机构通信。在某些情况下,如果所确定的由电动马达4331消耗的电流的增量百分比的值超过预定义阈值,则处理器4315可例如采用反馈系统警示用户。在某些情况下,如果所确定的由电动马达4331消耗的电流的增量百分比的值超过预定义阈值,则处理器4315可例如采用闭锁机构来阻止切割边缘182(图14)的推进。在某些情况下,系统4311可包括第一和第二位置传感器4321、4323。外科器械10(图1至图4)可包括负荷单元4335。
在各种情况下,控制器4313可利用算法确定由电动马达4331消耗的电流的变化。例如,电流传感器可检测击发行程期间由电动马达4331消耗的电流。电流传感器可连续检测由电动马达消耗的电流,并且/或者可间歇性地检测由电动马达消耗的电流。在各种情况下,算法可比较最新的电流读数与例如紧接进展的电流读数。除此之外或另选地,算法可比较时间段X内的样品读数X与此前的电流读数。例如,算法可比较样品读数与例如此前的时间段X(诸如紧接进展的时间段X)内的样品读数。在其它情况下,算法可计算由马达消耗的电流趋势平均值。算法可计算时间段X期间消耗的平均电流(包括例如最新电流读数),并且可比较消耗的平均电流与例如在紧接进展的时间段X期间消耗的平均电流。
在某些情况下,负荷单元4335(图19、图20)可被配置成能够例如当切割边缘182(图14)接合和/或接触锐度测试构件4302(图19、图20)时监控施加到切割边缘182的力(Fx)。读者将会知道,当切割刃182接合和/或接触锐度测试构件4302时由锐度测试构件4302施加到切割刃182的力(Fx)至少部分地取决于切割刃182的锐度。在某些情况下,切割边缘182的锐度的降低可导致切割边缘182切割或穿过锐度测试构件4302所需的力(Fx)增加。在某些情况下,控制器4313(图19、图20)可将施加到切割边缘182(图14)的监测力(Fx)的最大值与一个或多个预定义阈值进行比较。
在某些情况下,例如,切割边缘182(图14)可足够锐利以横切具有第一厚度的所捕集组织,但可不足够锐利以横切具有大于第一厚度的第二厚度的所捕集组织。在某些情况下,例如,如果所捕集组织具有位于特定组织厚度范围内的组织厚度,则由切割刃182横切所捕集组织所需的力限定的切割刃182的锐度水平可足以横切所捕集组织。在某些情况下,存储器4317(图19、图20)可以存储由端部执行器300捕集的组织的一个或多个预定范围的组织厚度;并且预定义的阈值力与预定范围的组织厚度相关联。在某些情况下,每个预定义阈值力可表示适于横切具有组织厚度(Tx)的所捕集组织的切割刃182的最小锐度水平,该组织厚度(Tx)由与预定义阈值力相关联的组织厚度范围涵盖。在某些情况下,当切割边缘182横切具有组织厚度(Tx)的所捕集组织所需的力(Fx)超过例如与涵盖组织厚度(Tx)的预定义组织厚度范围相关联的预定义阈值力,则切割边缘182可不足够锐利以横切所捕集组织。
在各个方面,本公开提供了用于确定组织压缩的技术以及用于响应于组织压缩来控制外科器械10(结合图1至图18描述)的操作的附加技术。在一个示例中,仓可以被配置成能够限定可变压缩算法,其基于预期的组织类型和厚度驱动外科器械10不同地闭合。在另一个示例中,外科器械10从外科医生使用和原始组织压缩轮廓中学习,以基于在击发期间经历的负载来适应闭合。当外科器械10经历与该仓类型所经历的组织压缩负载明显不同的组织压缩负载时,该器械向用户强调这一点。
当器械适应医院的使用时,随时间变化主动调整马达控制算法可以改善可再充电电池的预期寿命,并且可以调整组织/程序要求以最小化组织流动,从而改善组织密封中的钉形成。
因此,本发明涉及外科器械,并且在各种情况下,涉及被设计成用于缝合和切割组织的外科缝合和切割器械及其钉仓。例如,在各个方面,本公开提供了一种内窥镜器械,其被配置成能够感测仓类型或组织间隙,以使柄部能够调整闭合和击发算法来调整预期的组织特性。这种自适应算法调整可以从用户的操作中“学习”,从而允许装置对两个不同的系统做出反应并使其受益。由所公开的自适应算法提供的第一个益处包括组织流动和钉形成。当装置了解用户的基本习惯和步骤时间时,装置可以调整闭合速度和击发速度,以提供更一致和可靠的输出。由所公开的自适应算法提供的第二个益处与电池组相关。当装置学习了该器械使用的击发次数和条件时,该装置可以预定义的方式调整马达电流需求/速度,以延长电池寿命。在医院中使用的主要进行减肥规程的装置的可能性很小,其操作方式类似于主要执行结肠直肠或胸腔规程的医院中使用的装置。因此,当该装置用于执行基本上类似的规程时,随时间变化,该装置被配置成能够学习并调整其操作算法以维持在“理想的”排出和组织流动包层内。
安全有效的手术需要对所涉及的组织有适当的了解和尊重。临床医生注意到在手术期间进行的调整可能是有益的。这些调整包括检测和促进所需钉形成的机制。
内窥镜器械在其与外科手术相关的使用期间可以生成、监测和处理大量数据。此种数据可以从外科器械本身获得,包括电池使用。除此之外,可以从外科器械与之相互作用的组织的特性获得数据,包括诸如组织压缩的特性。此外,可以从临床医生与外科器械本身的相互作用中获得数据。可以处理如此获得的数据储存库,并且在需要时,外科器械可以设计成适应环境,以促进当前外科手术的安全有效的结果,并为多个临床医生更广泛的生产用途奠定基础。此种适应性调整—在外科手术期间,以及其中器械基于从多个外科手术过程中获得的使用模式“学习”—可以提供多种机制来增强整个患者护理环境。
图21示出了用于适应外科器械的操作的过程的一个方面。如图21所描绘的,模块可以附接或以其它方式加载到外科器械10(步骤5160)(图1至图4)。该模块可以包含被选择或上载的程序(步骤5162)。可以启动控件(步骤5164),使得它们可以准备好操作外科器械10。在使用外科器械10期间或之后,可以包括控制措施以适应程序(步骤5166)。例如,这可以包括调整外科器械10内的数据速率或者相对于外科器械10的远程操作。这可以包括调节速度,诸如砧座306(图1)和外科钉仓304(图1)在闭合运动中接合的速度。这还可以包括来自发射器和传感器的脉冲,或者向组织施加电流脉冲,以及此种脉冲的定时。这可以包括调整程序以适应加速度,诸如如果掉落则加速外科器械10,或者从睡眠模式转换。程序可以适于基于夹持力处理实际和/或预期的负载。
外科器械10(图1至图4)可用于完成动作(步骤5168),例如以执行缝合规程。可以将数据记录(步骤5170)在外科器械10的适当存储位置中。可以评估传感器行为(步骤5172),诸如传感器精确测量和/或测量参数的程度。可以评估预期数据(步骤5174),包括但不限于组织特性、等待时间和击发速度。本文公开的前述机制可以提供输入以进一步适应程序(步骤5166)。另外,可以基于历史、实际或预期的组织特性来执行组织识别(步骤5178),并且这可以提供输入以进一步调整程序(步骤5166)。另外,可以更新组织识别特性(步骤5178)。而且,在规程期间测量的传感器输入(步骤5176)可以用作附加输入以进一步适应程序(步骤5166);此种传感器测量值可以包括砧座306与外科钉仓304之间的间隙的那些,从而获得包括函数、电流或扭矩的导数的导数测量值。
端部执行器6006可用于压缩、切割或缝合组织。现在参见图23A,在进行压缩、切割或缝合之前,医师可将端部执行器6030定位成围绕组织6032。如图23A所示,在准备使用端部执行器时,不可对组织施加压缩。现在参见图23B,通过接合内镜切割器的柄部(例如,柄部6002),医生可使用端部执行器6030来压缩组织6032。在一个方面,组织6032可被压缩到其最大阈值,如图23B所示。
参见图23A,可通过端部执行器6030将各种力施加到组织6032。例如,当组织6032被压缩在端部执行器6030的砧座6034和通道框架6036之间时,可通过砧座和通道框架施加垂直力F1和F2。现在参见图23B,当组织被端部执行器6030压缩时,还可向组织6032施加各种对角线力和/或横向力。例如,可施加力F3。为了操作医疗装置诸如内镜切割器6000,期望感测或计算由端部执行器施加到组织的各种形式的压缩。例如,已知垂直或侧向压缩可允许端部执行器更精确或准确地实施钉操作或者可通知内镜切割器的操作者,从而能够更正确或安全地使用内镜切割器。
可以从组织6032的阻抗确定穿过组织6032的压缩。在各种压缩水平下,组织6032的阻抗Z可以增大或减小。通过将电压V和电流I施加到组织6032,可以在各种压缩水平下确定组织6032的阻抗Z。例如,可以通过将施加的电压V除以电流I来计算阻抗Z。
现在参见图24,在一个方面,RF电极6038可定位在端部执行器6030上(例如,在端部执行器6030的钉仓、刀或通道框架上)。此外,电触点6040可以定位在端部执行器6030的砧座6034上。在一个方面,电触点可以定位在端部执行器的通道框架上。当组织6032在砧座6034与例如端部执行器6030的通道框架6036之间被压缩时,组织6032的阻抗Z改变。由端部执行器6030引起的垂直组织压缩6042可以作为组织6032的阻抗Z的函数来测量。
现在参见图25,在一个方面,当定位RF电极6038时,电触点6044可以定位在端部执行器6030的砧座6034的相对端上。当组织6032在砧座6034与例如端部执行器6030的通道框架6036之间被压缩时,组织6032的阻抗Z改变。由端部执行器6030引起的侧向组织压缩6046可以作为组织6032的阻抗Z的函数来测量。
现在参见图26,在一个方面,电触点6050可以定位在砧座6034上,并且电触点6052可以定位在通道框架6036处的端部执行器6030的相对端上。RF电极6048可以侧向于端部执行器6030的中心定位。当组织6032在砧座6034与例如端部执行器6030的通道框架6036之间被压缩时,组织6032的阻抗Z改变。RF电极6048两侧的侧向压缩或角度压缩6054和6056可以由端部执行器6030引起,并且可以基于RF电极6048和电触点6050和6052的相对定位、作为组织6032的不同阻抗Z的函数来测量。
根据本公开中描述的一个或多个技术和特征,并且如上所述,RF电极可以用作RF传感器。现在参见图27,在一个方面,RF传感器6062可以定位在插入到端部执行器的通道框架6066中的钉仓6060上。RF电极可以从电源线6064延伸,该电源线可以由内镜切割器的柄部(例如,柄部6002)中的电源供电。
现在参见图28,在一个方面,RF电极6074和6076可以定位在插入到端部执行器6070的通道框架6078中的钉仓6072上。如图所示,RF电极6074可以相对于内镜切割器柄部放置在端部执行器的近侧端部位置。此外,RF电极6076可以相对于内镜切割器柄部放置在端部执行器的远侧位置。RF电极6074和6076可用于基于端部执行器上的一个或多个电触点的位置来测量组织中不同点处的垂直、侧向、近侧或远侧压缩。
现在参见图29,在一个方面,RF电极6084-6116可以基于期望的压缩信息的各个点定位在插入到通道框架6080(或端部执行器的其它部件)中的钉仓6082上。现在参见图30,在一个方面,RF电极6122-6140可以在期望的压缩信息的离散点处定位在钉仓6120上。现在参见图31,RF电极6152-6172可以基于压缩测量的准确度或精确度定位在钉仓的多个区域中的不同点处。例如,RF电极6152-6156可以定位在钉仓6150的区域6158中,这取决于区域6158中的压缩测量的准确度或精确度。此外,RF电极6160-6164可以定位在钉仓6150的区域6166中,这取决于区域6166中的压缩测量的准确度或精确度。除此之外,RF电极6168-6172可以定位在钉仓6150的区域6174中,这取决于区域6174中的压缩测量的准确度或精确度。
本文讨论的RF电极可以通过插入通道框架中的钉仓进行布线。现在参见图32,在一个方面,RF电极可以具有直径约1.0mm的冲压“蘑菇头”6180。当RF电极可以具有直径约1.0mm的冲压“蘑菇头”时,该旨在是非限制性示例,并且RF电极可以根据每个特定应用或设计而具有不同的形状和尺寸。RF电极可以连接到、紧固到传导线6182或者可以形成该传导线。传导线6182的直径可以是约0.5mm,或者可以具有基于特定应用或设计的更大或更小的直径。此外,传导线可以具有绝缘涂层6184。在一个示例中,RF电极可以突出穿过钉仓、通道框架、刀或端部执行器的其它部件。
现在参见图33,RF电极可以穿过单个壁或穿过端部执行器的钉仓或通道框架的多个壁。例如,RF电极6190-6194可以穿过钉仓的壁6196或端部执行器的通道框架。线6198中的一个或多个可以连接到、紧固到RF电极6190-6194,或者是其的一部分,并且可以从例如内镜切割器的柄部中的电源穿过壁6196。
现在参见图34,电源可以与RF电极通信,或者可以通过线或缆线向RF电极提供电力。线或缆线可以接合每根单独的线并通向电源。例如,RF电极6204-6212可以通过线或缆线6202从电源接收电力,该线或缆线可以穿过钉仓6200或端部执行器的通道框架延伸。在一个示例中,RF电极6204-6212中的每一个可以具有其自身的线,该线延伸到或穿过线或缆线6202。钉仓6200或通道框架还可包括控制器6214,诸如结合图16A和图16B所示的主处理器2006,或者例如结合图17A、图17B和图18所示的主控制器3017。应当理解,控制器6214应定尺寸成适配于钉仓6200或通道框架形状因子中。还有,控制器
在各个方面,本文描述的用于医疗装置的组织压缩传感器系统可包括频率发生器。频率发生器可以位于医疗装置的电路板上,诸如内镜切割器。例如,频率发生器可以位于内镜切割器的轴或柄部中的电路板上。现在参见图35,其示出了根据本公开的一个示例的示例电路图6220。如图所示,频率发生器6222可以从电源6221接收电力或电流,并且可以将一个或多个RF信号供应给一个或多个RF电极6224。如上所述,一个或多个RF电极可以定位在端部执行器或内镜切割器上的各种位置或部件上,诸如钉仓或通道框架。一个或多个电触点,诸如电触点6226或6228可以定位在端部执行器的通道框架或砧座上。此外,一个或多个滤波器,诸如滤波器6230或6232可以通信地联接到电触点6226或6228,如图35所示。滤波器6230和6232可以在接合单个返回路径6234之前对由频率发生器6222提供的一个或多个RF信号进行滤波。与一个或多个RF信号相关联的电压V和电流I可用于计算与组织相关联的阻抗Z,该组织可被压缩和/或通信地联接在一个或多个RF电极6224与电触点6226或6228之间。
现在参见图36,本文描述的组织压缩传感器系统的各种部件可位于内镜切割器的柄部6236中。例如,如电路图6220a所示,频率发生器6222可以位于柄部6236中并从电源6221接收电力。还有,可以在对应于电触点6228和6226的返回路径上测量电流I1和电流I2。使用在供应路径和返回路径之间施加的电压V可以计算阻抗Z1和Z2。Z1可以对应于在RF电极6224和电触点6228中的一个或多个之间压缩和/或通信联接的组织的阻抗。此外,Z2可以对应于在RF电极6224和电触点6226中的一个或多个之间压缩和/或通信联接的组织的阻抗。应用公式Z1=V/I1和Z2=V/I2可以计算对应于由端部执行器压缩的组织的不同压缩水平的阻抗Z1和Z2。
现在参见图37,在电路图6250中描述了本公开的一个或多个方面。在一种实施方式中,内镜切割器的柄部6252处的电源可以向频率发生器6254提供电力。频率发生器6254可以生成一个或多个RF信号。一个或多个RF信号可以在多路复用器6256处被多路复用或覆盖,该多路复用器可以在内镜切割器的轴6258中。这样,两个或多个RF信号可以被覆盖(或者,例如,嵌套或一起调制)并且被传输到端部执行器。一个或多个RF信号可以为内镜切割器的端部执行器6262(例如,定位在钉仓中)的一个或多个RF电极6260供电。组织(未示出)可以被压缩和/或通信地联接在RF电极6260中的一个或多个与一个或多个电触点之间。例如,组织可以被压缩和/或通信地联接在一个或多个RF电极6260和定位在端部执行器6262的通道框架中的电触点6264或位于端部执行器6262的砧座中的电触点6266之间。滤波器6268可以通信地联接到电触点6264,并且滤波器6270可以通信地联接到电触点6266。
与一个或多个RF信号相关联的电压V和电流I可以用于计算与可以在钉仓(并且通信地联接到一个或多个RF电极6260)和通道框架或砧座(并且通信地联接到电触点6264或6266中的一个或多个)之间被压缩的组织相关联的阻抗Z。
在一个方面,本文描述的组织压缩传感器系统的各种部件可位于内镜切割器的轴6258中。例如,如电路图6250所示(并且除了频率发生器6254之外),阻抗计算器6272、控制器6274、非易失性存储器6276和通信信道6278可以位于轴6258中。在一个示例中,频率发生器6254、阻抗计算器6272、控制器6274、非易失性存储器6276和通信信道6278可以定位在轴6258中的电路板上。
两个或多个RF信号可以经由电触点在公共路径上返回。此外,可以在公共路径上接合RF信号之前对两个或多个RF信号进行滤波,以区分由两个或多个RF信号表示的单独的组织阻抗。可以在对应于电触点6264和6266的返回路径上测量电流I1和电流I2。使用在供应路径和返回路径之间施加的电压V可以计算阻抗Z1和Z2。Z1可以对应于在RF电极6260和电触点6264中的一个或多个之间压缩和/或通信联接的组织的阻抗。此外,Z2可以对应于在RF电极6260和电触点6266中的一个或多个之间压缩和/或通信联接的组织的阻抗。应用公式Z1=V/I1和Z2=V/I2可以计算对应于由端部执行器6262压缩的组织的不同压缩的阻抗Z1和Z2。在示例中,阻抗Z1和Z2可以由阻抗计算器6272计算。阻抗Z1和Z2可用于计算组织的各种压缩水平。
在一个方面,滤波器6268和6270可以是高Q滤波器,使得滤波器范围可以是窄的(例如,Q=10)。Q可以由中心频率(Wo)/带宽(BW)定义,其中Q=Wo/BW。在一个示例中,频率1可以是150kHz,频率2可以是300kHz。可行的阻抗测量范围可以是100kHz-20MHz。在各种示例中,可使用诸如相关、正交检测等的其它复杂技术来分离RF信号。
使用本文描述的一种或多种技术和特征,钉仓上的单个通电电极或端部执行器的隔离刀可用于同时进行多个组织压缩测量。如果两个或多个RF信号被重叠或多路复用(或嵌套或调制),则它们可以在端部执行器的单个功率侧向下传输,并且可以在通道框架或端部执行器的砧座上返回。如果在砧座和通道触点接合到公共返回路径之前将过滤器构建到砧座和通道触点中,则可以区分由两个路径表示的组织阻抗。这可以提供垂直组织与侧向组织压缩的量度。该方法还可以根据过滤器的布置和金属返回路径的位置提供近侧和远侧组织压缩。频率发生器和信号处理器可以位于电路板或子板(可能已经存在于内部切割器中)上的一个或多个芯片上。
在各个方面,本公开提供了用于监测外科器械10中的驱动马达的速度和精度递增的技术(结合图1至图18描述)。在一个示例中,磁体可以放置在齿轮减速级中的一个的行星框架上,其中齿轮外壳上具有感应传感器。在另一个示例中,将磁体和磁场传感器放置在最后一级上将提供最精确的增量运动监测。
传统的马达控制系统采用编码器来检测手持式电池供电的内窥镜外科器械(诸如电动内镜切割器/缝合器装置)中的马达的位置和速度。内镜切割器/缝合器装置的精确操作部分地依赖于在负载下验证马达操作的能力。可以采用简单的传感器实施方式来实现在负载下验证马达操作。
因此,本公开包括在齿轮减速系统的行星齿轮架中的一个上的磁性体或采用无刷马达技术。两种方法都涉及将感应传感器布置在马达或行星齿轮系统的外部外壳上。在无刷马达的情况下,存在围绕马达的中心磁轴径向排列的电磁场线圈(绕组、电感器等)。这些线圈被顺序地启动和停用以驱动中心马达轴。一个或多个感应传感器可以放置在马达外部并且与至少一些线圈相邻,以感测马达绕组的激活/停用循环,确定轴已经旋转的次数。另选地,永磁体可以放置在行星齿轮架中的一个上,并且感应传感器可以放置在行星架的径向路径附近,以测量齿轮系的一级旋转的次数。该实施方式可以应用于系统中的任何旋转部件,在功能期间具有相对大的旋转数的区域中可以具有越来越多的分辨率,或者随着旋转部件根据设计变得更接近(就连接数而言)端部执行器。齿轮系感测方法可能是优选的,因为它实际上测量其中一个级的旋转,而马达感测方法感测马达被命令供电的次数,而不是实际的轴旋转。例如,如果马达在高负载下失速,则马达感测方法将无法检测到旋转不足,因为它仅感测到通电循环而不是轴旋转。然而,两种技术都可以以成本有效的方式用于感测马达旋转。
在缝合期间,例如,在将钉驱动到被夹持的组织中之前,将组织牢固地夹持在相对的钳口之间。夹持期间的组织压缩可导致流体从压缩组织移位,并且位移的速率或量根据组织类型、组织厚度、外科手术(例如,夹持压力和夹持时间)而变化。在各种情况下,端部执行器的相对钳口之间的流体位移可促使相对钳口之间的钉发生变形(例如,弯曲)。因此,在各种情况下,可能有利的是,基于检测到外科端部执行器的相对钳口中间有流体流动或没有流体流动而控制击发行程,例如控制击发速度。
因此,本文还提供了用于监测外科器械驱动系的速度和增量运动的方法,其继而又提供了关于该装置的操作速度的信息(例如,钳口闭合、缝合)。根据本示例,外科器械10(图1至图4)不包括马达编码器。相反,根据例示性示例,外科器械10可配备有马达,该马达包括用于马达的动力传动系的速度传感器组件。速度传感器组件可包括具有输出轴的马达,该输出轴直接或间接地联接到驱动轴。在一些示例中,输出轴连接到齿轮减速组件,诸如行星齿轮系,该行星齿轮系包括检测系统的任何合适部件的旋转速度的传感器。例如,传感器可以是接近传感器,诸如感应传感器,其检测附接到齿轮减速组件的任何旋转部分的一个或多个可检测元件的运动。可检测元件附接到末级环形齿轮,并且传感器定位在可检测元件的径向路径附近,以便检测可检测元件的运动。旋转部件可以根据设计而变化,并且传感器可以附接到齿轮减速组件的任何旋转部件上。例如,在另一个示例中,可检测元件与末级的承载齿轮或甚至驱动齿轮相关联。在一些示例中,可检测元件位于齿轮减速组件的外部,诸如位于齿轮减速组件与端部执行器之间的驱动轴上。在一些示例中,可检测元件位于端部执行器处的最终齿轮减速中的旋转部件上。
可以利用先前描述的电路实现各种功能。例如,马达可以用类似于结合图16A、图16B、图17A、图17B和图18描述的马达控制器来控制,其中编码器被替换为本文描述的用于电动外科器械的马达系统的监测速度控制和精确递增。
在一个方面,本公开提供了一种构造有各种感测系统的外科器械10(结合图1至图18描述)。因此,为方便和清楚起见,此处将不重复对操作和构造的细节。在一个方面,感测系统包括粘弹性/变化率感测系统,以监测刀加速度、阻抗变化率和组织接触变化率。在一个示例中,刀加速度的变化率可以用作组织类型的量度。在另一个示例中,阻抗的变化率可以用脉冲传感器测量,并且可以用作可压缩性的量度。最后,可使用基于刀击发速率的传感器测量组织接触的变化率以测量组织流动。
感测参数的变化率或另外说明的是,组织参数达到渐近稳态值需要多长时间,其本身是单独的测量,并且可能比其衍生的感测参数更有价值。为了增强组织参数的测量,诸如在进行测量之前等待预先确定量的时间,本公开提供了一种用于采用该测量衍生的新颖技术,诸如组织参数的变化率。
衍生技术或变化率测量变得最有用,应理解,不存在单独的测量可以单独采用以显著改善钉形成。多种测量的组合使测量有效。在组织间隙的情况下,了解有多少钳口被组织覆盖以使间隙测量相关是有帮助的。阻抗的变化率测量可以与砧座中的应变测量结合,以将施加到抓握于端部执行器的钳口构件(诸如砧座和钉仓)之间的组织的力和压力相关联。内窥镜外科装置可以采用变化率测量来确定组织类型而不仅仅是组织压缩。虽然胃和肺组织有时具有相似的厚度,甚至在肺组织钙化时具有相似的压缩特性,但是器械可以通过采用诸如间隙、压缩、施加的力、组织接触区域、压缩变化率或间隙变化率的测量的组合来区分这些组织类型。如果单独使用这些测量中的任何一个,则内窥镜外科装置可能难以将一种组织类型与另一种组织类型区分开来。压缩变化率也可能有助于使装置确定组织是否“正常”或是否存在某些异常。不仅要测量已经过了多少时间,而且要测量传感器信号的变化并确定信号的衍生将提供另一种测量以使得内窥镜外科装置能够测量信号。还可以采用变化率信息来确定何时达到稳态以发信号通知过程中的下一步骤。例如,在将组织抓握在端部执行器(诸如砧座和钉仓)的钳口构件之间之后,当组织压缩达到稳态(例如,大约15秒)时,开始击发装置的指示器或触发器可以被启用。
本文还提供了用于对传感器数据进行时间依赖性评估以确定外科器械操作期间组织的稳定性、蠕变和粘弹性特征的方法、装置和系统。外科器械10,诸如图1中所示的缝合器,可以包括用于测量操作参数的各种传感器,诸如钳口间隙尺寸或距离、击发电流、组织压缩、被组织覆盖的钳口的量、砧座应变和触发力等等。这些感测的测量对于外科器械的自动控制和向临床医生提供反馈是重要的。
可以采用结合图22A至图37示出的示例来测量各种衍生的参数,诸如间隙距离与时间、组织压缩与时间、以及砧座应变与时间。可以采用与如本文描述的电池2308串联的电流传感器2312来监测马达电流,电流传感器2412与图18中的电池2408或电流传感器3027串联。
图38示出了用于切割和紧固的马达驱动的外科器械8010,其可以重复使用或不重复使用。外科器械8010类似地构造和配备为结合图1至图18描述的用于切割和紧固的外科器械10。在图38所示示例中,外科器械8010包括外壳8012,该外壳包括被构造成能够由临床医生抓握、操纵并致动的柄部组件8014。外壳8012被构造成能够可操作地附接到可互换轴组件8200,该可互换轴组件具有可操作地联接到其上的端部执行器8300,该端部执行器被配置成能够执行一种或多种手术任务或外科手术。由于外科器械8010类似地构造和配备为结合图1至图18描述的用于切割和紧固的外科器械10,为方便和清楚起见,此处将不重复对操作和构造的细节。
图38所示的外壳8012结合可互换轴组件8200示出,该可互换轴组件包括端部执行器8300,该端部执行器包括被构造成能够在其中可操作地支撑外科钉仓8304的外科切割和紧固装置。外壳8012可被构造用于与可互换轴组件结合使用,该可互换轴组件包括端部执行器,该端部执行器适于支撑不同尺寸和类型的钉仓,具有不同的轴长度、尺寸和类型等。另外,外壳8012还可有效地用于多种其它可互换轴组件,其包括被配置成能够将其它运动和形式的能量(诸如例如射频(RF)能量、超声能量和/或运动)施加到适合与各种外科应用和手术结合使用的端部执行器布置的那些组件。此外,该端部执行器、轴组件、柄部、外科器械和/或外科器械系统可利用任何一种或多种合适的紧固件来紧固组织。例如,包括可移除地被存储在其中的多个紧固件的紧固件仓能够可移除地插入轴组件的端部执行器中和/或附接到轴组件的端部执行器。
现在转到图38,其描绘了可以重复使用或不重复使用的外科器械8010。外科器械8010类似地构造和配备为本文描述的用于切割和紧固的外科器械10。在图38所示示例中,外科器械8010包括外壳8012,该外壳包括被构造成能够由临床医生抓握、操纵并致动的柄部组件8014。外壳8012被构造成能够可操作地附接到可互换轴组件8200,该可互换轴组件具有可操作地联接到其上的端部执行器8300,该端部执行器被配置成能够执行一种或多种手术任务或外科手术。由于外科器械8010类似地构造和配备为结合本文图1至图18描述的用于切割和紧固的外科器械10,为方便和清楚起见,此处将不重复对操作和构造的细节。
图38所示的外壳8012结合可互换轴组件8200示出,该可互换轴组件包括端部执行器8300,该端部执行器包括被构造成能够在其中可操作地支撑外科钉仓8304的外科切割和紧固装置。外壳8012可被构造用于与可互换轴组件结合使用,该可互换轴组件包括端部执行器,该端部执行器适于支撑不同尺寸和类型的钉仓,具有不同的轴长度、尺寸和类型等。另外,外壳8012还可有效地用于多种其它可互换轴组件,其包括被配置成能够将其它运动和形式的能量(诸如例如射频(RF)能量、超声能量和/或运动)施加到适合与各种外科应用和手术结合使用的端部执行器布置的那些组件。此外,该端部执行器、轴组件、柄部、外科器械和/或外科器械系统可利用任何一种或多种合适的紧固件来紧固组织。例如,包括可移除地被存储在其中的多个紧固件的紧固件仓能够可移除地插入轴组件的端部执行器中和/或附接到轴组件的端部执行器。
图38示出了具有可操作地联接至其的可互换轴组件8200的外科器械8010。在示出的构造中,柄部外壳形成可被临床医生抓握和操纵的手枪式握把部8019。柄部组件8014在其中操作地支撑多个驱动系统,该多个驱动系统被配置成能够生成并将各种控制运动施加到操作地附接到其的可互换轴组件的对应部分。触发器8032可操作地与手枪式握持部相关联,用于控制各种这些控制运动。
继续参见图38,可互换轴组件8200包括外科端部执行器8300,该外科端部执行器包括被构造成能够可操作地支撑其中的钉仓8304的细长通道8302。端部执行器8300还可包括砧座8306,该砧座相对于细长通道8302可枢转地支撑。
本发明人已经发现,对于控制外科器械(诸如图38中所示的器械),衍生参数甚至比衍生参数所基于的感测参数更有用。衍生参数的非限制性示例包括感测参数的变化率(例如,钳口间隙距离)以及在组织参数达到渐近稳态值(例如,15秒)之前经过的时间长度。衍生参数(诸如变化率)特别有用,因为它们显著提高了测量精度,并且还提供了直接来自感测参数的信息。例如,阻抗(即,组织压缩)变化率可以与砧座中的应变组合,以将压缩和力相关联,这使得控制器能够确定组织类型而不仅仅是组织压缩量。该示例仅是示例性的,并且任何衍生参数可以与一个或多个感测参数组合,以提供关于组织类型(例如,胃与肺)、组织健康(钙化与正常)和外科装置操作状态的更准确信息(例如,夹持完成)。不同的组织具有独特的粘弹特性和独特的变化率,使得本文讨论的这些和其它参数成为监测和自动调整外科手术的有用标记。
具体地,参见图38和图39,间隙8040是砧座8306与端部执行器8300的细长通道8302之间的距离。在打开钳口位置,在时间零点,砧座8306与细长构件之间的间隙8040处于其最大距离。间隙8040的宽度随砧座8306的闭合而减小,诸如在组织夹持期间。间隙距离变化率可以变化,因为组织具有不均匀的弹性。例如,某些组织类型最初可能显示出快速压缩,从而导致更快的变化速率。然而,随着组织被连续压缩,组织的粘弹性可导致变化率降低,直到组织不能被进一步压缩,此时间隙距离将保持基本恒定。随着组织在端部执行器8300的砧座8306和外科钉仓8304之间被挤压,间隙随时间变化而减小。结合图22A至图37和图40描述的一个或多个传感器可以适于并被配置成能够测量砧座8306与外科钉仓8304之间随时间t变化的间隙距离“d”,并且间隙距离“d”随时间t的变化率是曲线的斜率,其中斜率=Δd/Δt。另外,击发电流的变化率可以用作组织从一种状态转变到另一种状态的指示。因此,击发电流,特别是击发电流的变化率可用于监测装置操作。当刀切穿组织时,击发电流随时间变化而降低。如果被切割的组织由于刀8305(图39)的组织特性或锐度而提供或多或少的阻力,则击发电流的变化率可以变化。例如,可以采用与如本文描述的电池2308串联的电流传感器2312、与本文所示的电池2408串联的电流传感器2412、或图18中所示的电流传感器3027来监测马达电流。电流传感器2312、2314、3027可以适于并被配置成能够在时间t上测量马达击发电流“i”,并且击发电流“i”随时间t的变化率是曲线的斜率,其中斜率=Δi/Δt。结合图22A至图37和图40描述的传感器可以适于并被配置成能够测量组织的压缩/阻抗。这些传感器可以适于并被配置成能够在时间t上测量组织阻抗“Z”,并且组织阻抗“Z”随时间t的变化率是斜率,其中斜率=ΔZ/Δt。砧座8306应变的变化率可以通过定位于砧座8306与外科钉仓8304(图38、图39)中的任一个或两个上的压力传感器或应变仪来测量,以测量施加到被抓握在砧座8306和外科钉仓8304之间的组织上的压力或应变。因此,在时间零点,触发器8020(图38)压力可以处于其最低值并且触发压力可以增加直到操作完成(例如,夹持、切割或缝合)为止。可以通过定位于外科器械8010(图38)的柄部的手枪式握把部分8019的触发器8032上的压力传感器或应变仪测量变化率触发力,以测量驱动刀8305(图39)穿过砧座8306与外科钉仓8304之间夹持的组织所需的力。
暂时转向图40,端部执行器9012是端部执行器8300(图38)的一个方面,其可以适于与外科器械8010(图38)一起操作,以测量各个衍生参数,诸如间隙距离与时间、组织压缩与时间和砧座应变与时间。因此,图40中所示的端部执行器9012可以包括一个或多个传感器,这些传感器被配置成能够测量与端部执行器9012相关联的一个或多个参数或特性,并且/或者由端部执行器9012捕集的组织节段。在图40所示的示例中,端部执行器9012包括第一传感器9020和第二传感器9026。在各种示例中,第一传感器9020和/或第二传感器9026可包括例如磁性传感器(诸如磁场传感器)、应变仪、压力传感器、力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或用于测量端部执行器9012的一个或多个参数的任何其它合适的传感器。
在某些情况下,第一传感器9020和/或第二传感器9026可以包括例如嵌入砧座9014中的磁场传感器,并且被配置成能够检测由嵌入在钳口构件9016和/或钉仓9018中的磁体9024产生的磁场。砧座9014可在打开和闭合位置之间枢转地旋转。检测到的磁场的强度可对应于例如定位在砧座9014和钳口构件9016之间的组织的厚度和/或咬合完全性。在某些情况下,第一传感器9020和/或第二传感器9026可包括应变仪,诸如微应变仪,其被配置成能够在夹持状态期间测量砧座9014中的应变量值。应变仪提供电信号,该电信号的幅值随着应变量值而变化。
在一些方面,端部执行器9012的一个或多个传感器(诸如,第一传感器9020和/或第二传感器9026)可包括压力传感器,该压力传感器被配置成能够检测由砧座9014与钳口构件9016之间的压缩组织的存在而产生的压力。在一些示例中,端部执行器9012的一个或多个传感器(诸如,第一传感器9020和/或第二传感器9026)被配置成能够检测位于砧座9014与钳口构件9016之间的组织节段的阻抗。检测到的阻抗可表征定位在砧座9014与钳口构件9016之间的组织的厚度和/或完全性。
在一个方面,端部执行器9012的一个或多个传感器(诸如,第一传感器9020)被配置成能够测量砧座9014与钳口构件9016之间的间隙9022。在某些情况下,间隙9022可以表示夹持在砧座9014和钳口构件9016之间的组织节段的厚度和/或可压缩性。在至少一个示例中,间隙9022可以等于或基本上等于夹持在砧座9014与钳口构件9016之间的组织节段的厚度。在一个示例中,端部执行器9012的一个或多个传感器(诸如,第一传感器9020)被配置成能够测量由钳口构件9016和/或夹在砧座9014和钳口构件9016之间的组织施加在砧座9014上的一个或多个力。施加在砧座9014上的力可以代表在砧座9014与钳口构件9016之间捕集的组织节段所经历的组织压缩。在一个方面,砧座9014与钳口构件9016之间的间隙9022可以通过将磁场传感器定位在砧座9014上并将磁体定位在钳口构件9016上以使得间隙9022与磁场传感器检测到的信号成比例、并且信号与磁铁与磁场传感器之间的距离成比例来测量。应当理解,可以交换磁场传感器和磁体的位置,使得磁场传感器定位在钳口构件9016上,并且磁体放置在砧座9014上。
可以在夹持操作期间实时测量一个或多个传感器,诸如第一传感器9020和/或第二传感器9026。实时测量允许例如通过处理器分析基于时间的信息,并且用于选择一个或多个算法和/或查找表,以便实时评估手动输入外科器械9010的操作者。此外,可以向操作者提供实时反馈,以帮助操作者校准手动输入以产生期望的输出。
图41是示出实时反馈系统9060的一个方面的逻辑图,该实时反馈系统用于实时评估外科器械9010的操作者的手动输入9064并向操作者提供关于手动输入9064充分性的实时反馈。参照图40和图41,在图41所示的示例中,实时反馈系统9060包括电路。该电路包括控制器9061,该控制器包括处理器9062。处理器9062采用诸如第一传感器9020的传感器来测量端部执行器9012的参数。另外,处理器9062可以被配置成能够确定或接收表示外科器械9010的操作者的手动输入9064的值。只要手动输入9064由操作者提供,则手动输入9064就可以由处理器9062连续评估。处理器9062可以被配置成能够监测代表手动输入9064的值。此外,处理器9062被配置成能够相对于期望的区域或范围分配、选择或确定所确定值的位置、等级和/或状态。处理器9062可以采用端部执行器9012的参数的测量值和确定的值来选择或确定与所确定值相关联的位置、等级和/或状态,如下面更详细地描述的。手动输入9064的变化产生所确定值的变化,该变化继而又产生相对于期望区域或范围分配给所确定值的位置、等级和/或状态的变化。
如图41所示,实时反馈系统9060还可以包括反馈指示器9066,其可以在期望区域或范围内外的多个位置、等级和/或状态之间进行调整。在一个示例中,处理器9062可以基于端部执行器9012的参数的测量值(M1)和表示第一手动输入(I1)的第一确定值(V1)来选择表征手动输入9064的第一位置(P1)等级和/或状态。在某些情况下,第一位置(P1)、等级和/或状态可能落在期望区域或范围之外。在此种情况下,操作者可以通过例如增加或减少手动输入9064以将手动输入9064从第一手动输入(I1)改变为第二手动输入(I2)。作为响应,处理器9062可以将反馈指示器9066从第一位置(P1)、等级和/或状态调整到第二位置(P2)、等级和/或状态,其表征对手动输入9064的改变。处理器9062可以基于端部执行器9012的参数的测量值(M1)和表示第二手动输入(I2)的第二确定值(V2)来选择第二位置(I2)、等级和/或状态。在某些情况下,第二位置(P2)、等级和/或状态可能落在期望区域或范围之内。在此种情况下,例如,操作者可以在治疗周期或手术的剩余时间内维持第二手动输入(I2)。
在图41所示的方面中,控制器9061包括存储介质,诸如存储器9068。存储器9068可以被配置成能够存储端部执行器9012的一个或多个参数、表示手动输入的值、以及表征手动输入9064相对于期望区域或范围的对应位置、等级和/或状态之间的测量值的相关性。在一个示例中,存储器9068可以存储测量值(M1)、第一确定值(V1)与第一手动输入(I1)之间的相关性,以及测量值(M1)、第二确定值(V2)与第二手动输入(I2)之间的相关性。在一个示例中,存储器9068可以存储用于确定端部执行器9012的一个或多个参数的测量值之间相关性的算法、等式或查找表、表示手动输入的值、以及相对于期望区域或范围的对应的位置、等级或状态。处理器9062可以采用此种算法、等式和/或查找表,以表征由外科器械9010的操作者提供的手动输入9064,并且向操作者提供关于手动输入9064的充分性的反馈。
图42是实时反馈系统9070的一个方面的逻辑图。实时反馈系统9070在许多方面类似于实时反馈系统9060。例如,与实时反馈系统9060一样,实时反馈系统9070被配置成能够实时评估外科器械9010的操作者的手动输入,并且向操作者提供手动输入的充分性的实时反馈。此外,与实时反馈系统9060类似,实时反馈系统9070包括可包括控制器9061的电路。
在图42所示的方面中,传感器9072(诸如,应变仪或微应变仪)被配置成能够测量端部执行器9012的一个或多个参数,诸如,在夹持操作期间施加在砧座9014上的应变的幅值,该幅值可以指示组织压缩。将测得的应变转换成数字信号并将其提供给处理器9062。传感器9074(诸如负载传感器)可以测量力,以推进切割构件9040以切割在砧座9014与钉仓9018之间捕集的组织。另选地,可以采用电流传感器(未示出)来测量由马达9082消耗的电流。推进击发杆9036所需的力可对应于例如由马达9082消耗的电流。将测得的力转换成数字信号并将其提供给处理器9062。如上所述,可以采用传感器9076(诸如,磁场传感器)来测量所捕集组织的厚度。磁场传感器9076的测量也可被转换成数字信号并提供给处理器9062。
在图42所示的方面中,实时反馈系统9070还包括跟踪系统9080,其可以被配置成能够确定击发触发器的位置。如上所述,可以通过在多个位置之间移动击发触发器9094来按下或致动击发触发器9094,每个位置对应于击发冲程期间击发杆9036和/或切割构件9040的运动特征的多个值中的一个。如上所述,运动特征可以是击发冲程期间击发杆9036和/或切割构件9040的推进速度。在某些情况下,马达驱动器9092可以与控制器9061通信,并且可以被配置成能够根据跟踪系统9080检测到的操作者的手动输入来驱动马达9082。
除上述之外,实时反馈系统9070可以包括反馈指示器9066。在一个方面,反馈指示器9066可设置在柄部9030中。另选地,例如,反馈指示器可设置在轴组件9032中。在任何情况下,控制器9061可采用反馈指示器9066向外科器械9010的操作者提供关于手动输入的适当性的反馈,诸如例如,击发触发器9094的所选择的位置。为此,控制器9061可以评估击发触发器9094的选定位置、并且/或者击发杆9036和/或切割构件9040的速度的对应值。由传感器9072、9074和9076分别测量的组织压缩、组织厚度和/或推进击发杆9036所需的力的测量值可由控制器9061用于表征击发触发器9094选定位置和/或击发杆9036和/或切割构件9040的速度的对应值。在一种情况下,存储器9068可存储可由控制器9061在评估中所采用的算法、公式和/或查找表。在一个示例中,传感器9072、9074和/或9076的测量值可用于选择或确定表征击发触发器9094的选定位置和/或击发杆9036和/或切割构件9040的速度对应值的位置、等级和/或状态。可以经由反馈指示器9066将确定的位置、等级和/或状态传达给操作者。
读者将理解,击发冲程期间击发杆9036和/或切割构件9040的最佳速度可取决于端部执行器9012的若干参数,诸如,端部执行器9012捕集的组织的厚度、组织压缩、和/或推进击发杆9036以及继而推进切割构件9040所需的力。这样,控制器9061可以利用这些参数的测量值来评估切割构件9040通过捕集的组织的当前推进速度是否在最佳区域或范围内。
在一个方面,多个智能传感器可以定位在端部执行器的电源线上,并且可以通信地联接到内镜切割器的柄部。智能传感器可以相对于电源线串联或并联定位。现在参见图43,智能传感器12060和12062可以与信号处理组件或处理器12064通信,该处理器可以是智能传感器的本地处理器。智能传感器12060和12062以及处理器12064都可以位于端部执行器(由虚线框12066表示)。例如,智能传感器12060可以将信号或数据输出到运算放大器12068和ADC转换器12070,其可以调节信号或数据以输入到处理器12064。相似地,智能传感器12062可以将信号或数据输出到运算放大器12072和ADC转换器12074,其可以调节信号或数据以输入到处理器12064。
智能传感器12060和/或12062可以是不同类型的传感器或相同类型的传感器,其可以是例如磁场传感器、磁性传感器、感应传感器、电容传感器或医疗装置中使用的其它类型的传感器或内镜切割器。先前称为处理器的组件12064也可以是计算核、FPGA(现场可编程门阵列)、逻辑单元(例如,逻辑处理器或逻辑控制器)、信号处理单元或其它类型的处理器。处理器12064可以与诸如非易失性存储器12076的存储器通信,该存储器可以存储计算数据,设备信息诸如插入端部执行器12066中的仓的类型、表格数据或其它参考数据,这些数据使处理器12064能够处理从智能传感器12060或12062中一个或多个接收的信号或数据,以用于操作端部执行器12066或内镜切割器。
此外,轴12078可以包括返回路径,多个智能传感器(例如,智能传感器12060或12062)和柄部12080中的至少一个通过该返回路径通信地联接。轴可以包括一根或多根线,其可以将信息从处理器12064传输到柄部12080,以便操作端部执行器12066或内镜切割器。在一个示例中,来自处理器12064的信息可以通过以下中的一个或多个传递到柄部12080(通过轴12078或直接不使用轴12078):有线线路、单线线路、多线线路、无线通信协议(诸如蓝牙)、光学线路或声学线路。
在一个方面,定位于端部执行器处的多个智能传感器中的至少一个可包括信号处理组件。例如,信号处理组件可以内置在智能传感器中,或者可以作为单个模块本地地联接到智能传感器。信号处理组件可以被配置成能够处理从多个智能传感器中的至少一个的传感器组件(例如,传感器组件12020)接收的数据。柄部处的控制器12024(例如,控制器)可通信地联接到多个智能传感器中的至少一个。
在一个方面,智能传感器可以被配置成能够用于医疗装置中的本地信号处理。智能传感器可包括至少一个传感器组件(例如,传感器组件12020)和至少一个处理组件(例如,处理组件12022)。处理组件可以被配置成能够从至少一个传感器组件接收数据,并将数据处理成信息以供医疗装置使用。医疗装置可以是例如内镜切割器,但是这并不旨在对本公开进行限制。应当理解,本文讨论的用于具有本地信号处理的智能传感器的技术和特征可以用于任何医疗装置,其中传感器信号或数据的处理用于医疗装置的操作。
此外,医疗装置中的控制器(例如,控制器12024、控制器)可以被配置成能够从至少一个处理组件(例如,处理组件12022)接收信息(即,处理的信号或数据)。如上所述,医疗装置可以是外科器械诸如内镜切割器,并且智能传感器可以被配置成能够用于外科器械中的本地信号处理。本地信号处理可以指例如处理联接到传感器的处理组件处的传感器组件的信号或数据,其中所得到的处理信息可以由单独的组件使用。例如,控制器12024可以定位在外科器械(即,内镜切割器12010)的柄部12012中,并且智能传感器可以被配置成能够定位在外科器械(即,内镜切割器12010)的单独部件(即,端部执行器12016)中,与柄部12012分开。因此,控制器12024可以定位在外科器械的柄部12012处,并且信号处理组件12022和传感器12020可以位于与柄部12012分开的组件中(例如,端部执行器12016)。
这样,柄部或控制器12024不需要具有关于智能传感器的信息、智能传感器对正在做什么的了解、或者解释从智能传感器反馈数据的能力。这是因为处理组件12022可以转换或调节来自智能传感器的数据,并且从柄部或控制器12024可直接使用的数据中生成信息。由处理组件生成的信息可以直接使用,而不需要在医疗装置的另一部分(例如,在柄部12012或控制器12024附近)中处理来自智能传感器的数据。因此,可以基于来自传感器本地的信号处理组件的(处理的)信息来控制外科器械。
在一个方面,可以监视通信地联接到信号处理组件12022(即,传感器12020本地)的电源线上的电流消耗。电流消耗可以由轴12014或柄部12012处的处理器、控制器或其它监测设备监测,或者在与信号处理组件12022分开的另一处理器、控制器或其它监测设备监测。例如,监测可以是标准莫尔斯电码类型监测电源线上的电流消耗。基于电流消耗和特定传感器的外科器械的问题可以由例如柄部12012处的单独处理器确定。这样,监测可以允许柄部(或其中的处理器或控制器)被告知与由一个或多个传感器接收的信号或数据有关的各种问题,以及哪个特定传感器识别出该问题,而没有进一步的通信要求(例如,配对或其它联接通信)。
图44示出了电路13190的一个方面,该电路被配置成能够将来自第一传感器13158和多个第二传感器13160a、13160b的信号转换成能够由处理器(例如,主处理器2006)接收的数字信号(图16A至图16B)。电路13190包括模数转换器13194。在一些示例中,模数转换器13194包括4通道、18位模数转换器。本领域中的技术人员将会认识到,模数转换器13194可包括任何合适的通道数和/或位数以将一个或多个输入从模拟信号转换成数字信号。电路13190包括一个或多个电平转换电阻器13196,该电平转换电阻器被配置成能够接收来自第一传感器13158(例如,磁场传感器)的输入。电平转换电阻器13196调整来自第一传感器的输入,由此将该值转换成较高或较低电压,这取决于输入。电平转换电阻器13196将来自第一传感器13158的电平转换输入提供给模数转换器。
在一些方面,多个第二传感器13160a、13160b联接到多个电路13190内的桥13192a、13192b。多个桥13192a、13192b可对来自多个第二传感器13160a、13160b的输入提供滤波。在输入信号滤波之后,多个桥13192a、13192b将来自多个第二传感器13160a、13160b的输入提供给模数转换器13194。在一些示例中,联接到一个或多个电平转换电阻器的开关13198可联接到模数转换器13194。开关13198被配置成能够校正输入信号中的一个或多个,例如,来自磁场传感器的输入。开关13198可用于提供一个或多个电平转换信号,以调整传感器中的一个或多个的输入,例如由此来将校正磁场传感器的输入。在一些示例中,调整并非必需的,并且开关13198保持在打开位置以断开电平转换电阻器。开关13198联接到模数转换器13194。模数转换器13194将输出提供给一个或多个处理器,例如,主处理器2006(图16A至图16B)。主处理器2006基于来自模数转换器13194的输入来计算端部执行器13150的一个或多个参数。例如,在一个示例中,主处理器2006基于来自第一传感器13158和多个第二传感器13160a、13160b的输入来计算位于砧座13152与钉仓13156之间的组织的厚度。
图45示出了包括连接到磁场传感器13610和处理器13612的挠性缆线13630的钉仓13606的一个方面。钉仓13606类似于上文结合外科器械10(图1至图6)描述的外科钉仓304(图1)。图112为钉仓13606的分解图。钉仓13606包括仓体13620、楔形滑动件13618、仓托盘13622、和挠性缆线13630。挠性缆线13630还包括位于钉仓13606的近侧端部处的电触点13632,该电触点被布置成在钉仓13606与端部执行器(例如,下述端部执行器13800)可操作地联接时形成电连接。电触点13632与缆线迹线13634形成一体,该缆线迹线沿钉仓13606的长度的一部分延伸。缆线迹线13634在钉仓13606的远侧端部附近连接13636,并且此连接13636与传导联接件13614接合。磁场传感器13610和处理器13612可操作地联接到传导联接件13614,使得磁场传感器13610和处理器13612能够连通。
图46示出了具有挠性缆线13830的端部执行器13800的一个方面,该挠性缆线可操作以将电力提供给包括远侧传感器插头13816的钉仓13806。端部执行器13800类似于上文结合外科器械10(图1至图6)描述的端部执行器300(图1)。端部执行器13800包括砧座13802、钳口构件或细长通道13804、以及可操作地联接到细长通道13804的钉仓13806。端部执行器13800可操作地联接到轴组件。轴组件类似于上文结合外科器械10(图1至图6)描述的可互换轴组件200(图1)。轴组件还包括包封轴组件的外部的闭合管。在一些示例中,轴组件还包括关节运动接口13904,该关节运动接口包括双枢轴闭合套管组件。双枢轴闭合套管组件包括能够操作以与端部执行器13800联接的端部执行器闭合套管组件。
图47和图48示出了不含砧座13802或钉仓的端部执行器13800的细长通道13804部分,以便图示说明挠性缆线13830可如何置于细长通道13804内。在一些示例中,细长通道13804还包括用于接收挠性缆线13830的第三孔13824。在细长通道13804的主体内,挠性缆线分裂13834以形成位于细长通道13804的任一侧的延伸部13836。图48还示出连接器13838可操作地联接到挠性缆线延伸部13836。
图49示出了仅挠性缆线13830。如图所示,挠性缆线13830包括可操作以缠绕关节运动接口13904(图46)的单个线圈13832和附接到延伸部13836的分裂部13834。延伸部可联接到连接器13838,该连接器具有位于其远侧面向表面上的插针13840以用于联接到钉仓13806,如下所述。
图50示出了图47和48中所示的细长通道13804的近距离视图,该细长通道具有联接到其的钉仓13804。钉仓13804包括仓体13822和仓托盘13820。在一些示例中,钉仓13806还包括电迹线13828,该电迹线在钉仓13806的近侧端部处联接到近侧触点13856。近侧触点13856可被定位成与连接器13838的插针13840形成导电连接,该连接器联接到挠性缆线延伸部13836。因此,当钉仓13806与细长通道13804可操作地联接时,挠性缆线13830可通过连接器13838和连接器插针13840将电力提供给钉仓13806。
图51和图52示出了远侧传感器插头13816的一个方面。图51示出了远侧传感器插头13816的剖面图。如图所示,远侧传感器插头13816包括磁场传感器13810和处理器13812。远侧传感器插头13816还包括挠性板13814。如图52进一步所示,磁场传感器13810和处理器13812可操作地联接到挠性板13814,使得它们能够连通。
图53示出了具有挠性缆线13980的端部执行器13950的一个方面,该挠性缆线可操作以将电力提供给砧座13961部分的远侧末端13952中的传感器和电子器件。端部执行器13950包括砧座13961、钳口构件或细长通道13954、以及可操作地联接到细长通道的钉仓13956。端部执行器13950可操作地联接到轴组件13960。轴组件13960还包括包封轴组件13960的闭合管13962。在一些示例中,轴组件13960还包括关节运动接口13964,该关节运动接口包括双枢轴闭合套管组件13966。
在各个方面中,端部执行器13950还包括挠性缆线13980,该挠性缆线被配置成能够不干扰关节运动接口13964的功能。在一些示例中,闭合管13962包括挠性缆线13980可延伸穿过的第一孔13968。在一些示例中,挠性缆线13980还包括套环或线圈13982,该套环或线圈缠绕关节运动接口13964以使得挠性缆线13980不干扰关节运动接口13964的操作,如下文进一步所述。在一些示例中,挠性缆线13980沿砧座13961的长度延伸到砧座13961的远侧末端中的第二孔13970。
外科缝合器械16000的一部分示于图54至图56中。例如,缝合器械16000可与手动操作系统和/或机器人控制系统一起使用。缝合器械16000包括轴16010和从轴16010延伸的端部执行器16020。端部执行器16020包括仓通道16030和定位在仓通道16030中的钉仓16050。钉仓16050包括仓体16051和附接到仓体16051的保持器16057。仓体16051例如由塑料材料构成,保持器16057例如由金属构成。然而,仓体16051和保持器16057可由任何合适的材料构成。仓体16051包括被构造成能够支撑组织的平台16052、纵向狭槽16056、以及限定在平台16052中的多个钉腔16053。
主要参见图55和图56,钉16055可移除地定位在钉腔16053中,并由钉驱动器16054支撑,该钉驱动器也可动地定位在钉腔16053中。保持器16057围绕仓体16051的底部延伸,以保持钉驱动器16054和/或钉16055不会从钉腔16053的底部掉出。钉驱动器16054和钉16055可通过滑动件16060在未击发位置(图55)和击发位置之间运动。滑动件16060可在近侧未击发位置(图55)之间朝向远侧击发位置运动,以从钉仓16050射出钉16055,如图56所示。滑动件16060包括一个或多个倾斜表面16064,这些表面被构造成能够在钉驱动器16054下方滑动。端部执行器16020还包括被构造成能够在钉16055从钉仓16050射出时使钉16055变形的砧座16040。在各种情况下,砧座16040可包括限定在其中的成形凹坑16045,其构造成使钉16055变形。
轴16010包括框架16012和可相对于框架16012可动的外部套管16014。仓通道16030安装到轴框架16012并从其延伸。外部套管16014可操作地与砧座16040接合,并且被构造成能够使砧座16040在打开位置(图54)与闭合位置(图55)之间运动。在使用中,砧座16040可朝向定位在仓通道16030中的钉仓16050运动,以将组织夹持在钉仓16050的平台16052上。在各种替代方面,仓通道16030和钉仓16050可相对于砧座16040可动,以将组织夹持在其间。在任一种情况下,轴16010还包括击发构件16070,该击发构件被构造成能够向远侧推动滑动件16060。击发构件16070包括刀锋16076,该刀锋可在纵向狭槽16056内可动,并且被构造成当击发构件16070向远侧推进以将钉16055从钉仓16050射出时,切割位于砧座16040与钉仓16050中间的组织。击发构件16070还包括被构造成能够接合钉仓通道16030的第一凸轮16071以及被构造成能够接合砧座16040并将砧座16040相对于钉仓16050保持就位的第二凸轮16079。第一凸轮16071被构造成能够在仓通道16030下方滑动,第二凸轮16079被构造成能够在限定在砧座16040中的细长槽16049内滑动。
图57示出了包括第一传感器3008a和第二传感器3008b的端部执行器3011的一个方面。端部执行器3011类似于上述端部执行器300。端部执行器3011包括能够枢转地联接到钳口构件3004的砧座3013。钳口构件3004被构造成能够在其中接收钉仓3021。钉仓3021包括多个钉(未示出)。多个钉能够在外科操作期间从钉仓3021部署。端部执行器3011包括第一传感器3008a,其被配置成能够测量端部执行器3011的一个或多个参数。例如,在一个方面,第一传感器3008a被配置成能够测量砧座3013与钳口构件3004之间的间隙3023。第一传感器3008a可包括例如霍尔效应传感器,该霍尔效应传感器被配置成能够检测由嵌入第二钳口构件3004和/或钉仓3021中的磁体3012产生的磁场。又如,在一个方面,第一传感器3008a被配置成能够测量由第二钳口构件3004和/或夹持在砧座3013和第二钳口构件3004之间的组织施加到砧座3013上的一个或多个力。
端部执行器3011包括第二传感器3008b。第二传感器3008b被配置成能够测量端部执行器3011的一个或多个参数。例如,在各个方面,第二传感器3008b可包括应变仪,该应变仪被配置成能够测量夹持状态期间的砧座3013中的应变量值。应变仪提供电信号,该电信号的幅值随着应变量值而变化。在各个方面,第一传感器3008a和/或第二传感器3008b可包括例如磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或用于测量端部执行器3011的一个或多个参数的任何其它合适的传感器。第一传感器3008a和第二传感器3008b可被布置成串联构型和/或并联构型。在串联构型中,第二传感器3008b可被配置成能够直接影响第一传感器3008a的输出。在并联构型中,第二传感器3008b可被配置成能够间接影响第一传感器3008a的输出。
在一个方面,第一传感器3008a测得的一个或多个参数与第二传感器3008b测得的一个或多个参数相关。例如,在一个方面,第一传感器3008a被配置成能够测量砧座3013与钳口构件3004之间的间隙3023。间隙3023表示夹持在位于钳口构件3004的砧座3013与钉仓3021之间的组织节段的厚度和/或可压缩性。第一传感器3008a可包括例如霍尔效应传感器,该霍尔效应传感器被配置成能够检测由联接到第二钳口构件3004和/或钉仓3021的磁体3012产生的磁场。单个位置处的精确测量可描述经校正的组织的完全咬合的压缩组织厚度,但在组织的部分咬合设置在砧座3013与第二钳口构件3004之间时可提供不精确的结果。组织的部分咬合(近侧部分咬合或远侧部分咬合)改变砧座3013的夹持几何形状。
在一些方面,第二传感器3008b被配置成能够检测指示组织咬合类型(例如,完全咬合、部分近侧咬合、和/或部分远侧咬合)的一个或多个参数。第二传感器3008b的测量结果可用于调整第一传感器3008a的测量结果以精确地表示近侧或远侧定位的部分咬合的真实压缩组织厚度。例如,在一个方面,第二传感器3008b包括应变仪诸如微应变仪,该应变仪被配置成能够监控夹持状态期间的砧座中的应变幅值。砧座3013的应变幅值用于修改第一传感器3008a例如霍尔效应传感器的输出,以精确地表示近侧或远侧定位的部分咬合的真实压缩组织厚度。可在夹持操作期间实时地测量第一传感器3008a和第二传感器3008b。实时测量结果允许基于时间的信息例如由主处理器2006进行分析并且用于选择一个或多个算法和/或查找表,由此识别组织特性和夹持定位,以动态地调整组织厚度测量结果。
在一些方面,可将第一传感器3008a的组织测量结果提供给联接到端部执行器3011的外科器械10的输出装置。例如,在一个方面,端部执行器3011联接到包括显示器2028的外科器械10。将第一传感器3008a的测量结果提供给处理器,例如,主处理器2006。主处理器2006基于第二传感器3008b的测量结果调整第一传感器3008a的测量结果,以反映夹持在砧座3013与钉仓3021之间的组织节段的真实组织厚度。主处理器2006将调整的组织厚度测量结果和完全或部分咬合的指示输出到显示器2028。操作者可基于显示的值来确定是否部署钉仓3021中的钉。
在一些方面,第一传感器3008a和第二传感器3008b可定位在不同的环境中,例如,第一传感器3008a钉为在患者体内的治疗部位处并且第二传感器3008b定位在患者的外部。第二传感器3008b可被配置成能够校正和/或修改第一传感器3008a的输出。第一传感器3008a和/或第二传感器3008b可包括例如环境传感器。环境传感器可包括例如温度传感器、湿度传感器、压力传感器、和/或任何其它合适的环境传感器。
图58为逻辑图,其示出了用于确定并且显示夹持在端部执行器3011的砧座3013和钉仓3021之间的组织节段的厚度的方法3050的一个方面。方法3050包括通过例如定位在砧座3013的远侧末端处的霍尔效应传感器获得霍尔效应电压3052。将霍尔效应电压3052提供给模数转换器3054并且转换成数字信号。将数字信号提供给处理器,例如,主处理器2006。主处理器2006校正霍尔效应电压3052信号的曲线输入(步骤3056)。应变仪3058(例如,微应变仪)被配置成能够测量端部执行器3011的一个或多个参数,例如,夹持操作期间施加到砧座3013上的应变的幅值。将测得的应变转换3060成数字信号并且提供给处理器,例如,主处理器2006。主处理器2006响应于由应变仪3058测得的应变来利用一个或多个算法和/或查找表调整霍尔效应电压3052,以反映由砧座3013和钉仓3021夹持的组织的真实厚度和咬合完全性。将调整的厚度通过例如嵌入在外科器械10中的显示器2026显示给操作者(步骤3026)。
在一些方面,外科器械还可包括负荷传感器3082或负荷单元。负荷传感器3082可定位在例如可互换轴组件200中(如上所述)或者外壳12中(也如上所述)。
图59为逻辑图,其示出了用于确定并且显示夹持在端部执行器3011的砧座3013和钉仓3021之间的组织节段的厚度的方法3070的一个方面。该方法包括通过例如定位在砧座3013的远侧末端处的霍尔效应传感器获得霍尔效应电压3072。将霍尔效应电压3072提供给模数转换器3074并且转换成数字信号。将数字信号提供给处理器,例如,主处理器2006。主处理器2006对霍尔效应电压3072信号的曲线输入施加校正(步骤3076)。应变仪3078(例如,微应变仪)被配置成能够测量端部执行器3011的一个或多个参数,例如,夹持操作期间施加到砧座3013上的应变的幅值。将测得的应变转换成数字信号(步骤3080)并且提供给处理器,例如,主处理器2006。负荷传感器3082测量砧座3013相对于钉仓3021的夹持力。将测得的夹持力转换成数字信号(步骤3084)并且提供给处理器,例如,主处理器2006。主处理器2006响应于由应变仪3078测得的应变和由负荷传感器3082测得的夹持力来利用一个或多个算法和/或查找表调整霍尔效应电压3072,以反映由砧座3013和钉仓3021夹持的组织的真实厚度和咬合完全性。将调整的厚度通过例如嵌入在外科器械10中的显示器2026显示给操作者(步骤3026)。
图60示出了包括第一传感器3108a和第二传感器3108b的端部执行器3100的一个方面。端部执行器3100类似于端部执行器3011。端部执行器3100包括能够枢转地联接到钳口构件3104的砧座、砧座3102。钳口构件3104被构造成能够在其中接收钉仓3106。端部执行器3100包括联接到砧座3102的第一传感器3108a。第一传感器3108a被配置成能够测量端部执行器3100的一个或多个参数,例如,砧座3102与钉仓3106之间的间隙3110。间隙3110可对应于例如夹持在砧座3102和钉仓3106之间的组织的厚度。第一传感器3108a可包括任何合适的传感器,以用于测量端部执行器的一个或多个参数。例如,在各个方面中,第一传感器3108a可包括磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器。
在一些方面,端部执行器3100包括第二传感器3108b。第二传感器3108b联接到钳口构件3104和/或钉仓3106。第二传感器3108b被配置成能够检测端部执行器3100的一个或多个参数。例如,在一些方面,第二传感器3108b被配置成能够检测一个或多个器械状态,例如,联接到钳口构件3104的钉仓3106的颜色、钉仓3106的长度、端部执行器3100的夹持状态、端部执行器3100和/或钉仓3106的使用次数/剩余使用次数、和/或任何其它合适的器械状态。第二传感器3108b可包括用于检测一个或多个器械状态的任何合适的传感器,例如,磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器。
在一个方面,来自第二传感器3108b的输入可用于校正第一传感器3108a的输入。第二传感器3108b可被配置成能够检测钉仓3106的一个或多个参数,例如,钉仓3106的颜色和/或长度。检测的参数(例如,钉仓3106的颜色和/或长度)可对应于仓的一个或多个特性,例如,仓平台的高度、用于钉仓的可用/最佳组织厚度、和/或钉仓3106中的钉图案。钉仓3106的已知参数可用于调整由第一传感器3108a提供的厚度测量结果。例如,如果钉仓3106具有较高的平台高度,则可减小由第一传感器3108a提供的厚度测量结果以补偿增加的平台高度。可将调整的厚度通过例如联接到外科器械10的显示器2026显示给操作者。
图61示出了包括第一传感器3158和多个第二传感器3160a、3160b的端部执行器3150的一个方面。端部执行器3150包括砧座、或砧座3152和钳口构件3154。钳口构件3154被构造成能够接收钉仓3156。砧座3152能够相对于钳口构件3154枢转地运动以将组织夹持在砧座3152与钉仓3156之间。砧座包括第一传感器3158。第一传感器3158被配置成能够检测端部执行器3150的一个或多个参数,例如,砧座3152与钉仓3156之间的间隙3110。间隙3110可对应于例如夹持在砧座3152和钉仓3156之间的组织的厚度。第一传感器3158可包括任何合适的传感器,以用于检测端部执行器的一个或多个参数。例如,在各个方面,第一传感器3158可包括磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器。
在一些方面,端部执行器3150包括多个第二传感器3160a、3160b。第二传感器3160a,3160b被配置成能够检测端部执行器3150的一个或多个参数。例如,在一些方面,第二传感器3160a、3160b被配置成能够测量夹持期间施加到砧座3152上的应变的幅值。在各个方面,第二传感器3160a、3160b可包括磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器。第二传感器3160a,3160b可被配置成能够测量砧座3152的不同位置处的一个或多个相同参数、砧座3152上的相同位置处的不同参数、和/或砧座3152上的不同位置处的不同参数。
图62示出了包括多个传感器3208a-3208d的端部执行器3200的一个方面。端部执行器3200包括能够枢转地联接到钳口构件3204的砧座3202。钳口构件3204被构造成能够在其中接收钉仓3206。砧座3202包括其上的多个传感器3208a-3208d。多个传感器3208a-3208d被配置成能够检测端部执行器3200(诸如砧座3202)的一个或多个参数。多个传感器3208a-3208d可包括一个或多个相同传感器和/或不同传感器。多个传感器3208a-3208d可包括例如磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器或者它们的组合。例如,在一个方面,多个传感器3208a-3208d可包括多个应变仪。
在一个方面,多个传感器3208a-3208d允许实现鲁棒性组织厚度感测方法。通过检测沿砧座3202的长度的各个参数,多个传感器3208a-3208d允许外科器械(例如,外科器械10)计算钳口中的组织厚度,而无论咬合如何,例如,部分咬合或完全咬合。在一些方面,多个传感器3208a-3208d包括多个应变仪。多个应变仪被配置成能够测量砧座3202上的各个点处的应变。砧座3202上的各个点中的每个处的应变的幅值和/或斜率可用于确定砧座3202与钉仓3206之间的组织的厚度。多个应变仪可被配置成能够基于夹持动力学来优化最大幅值和/或斜率差,以确定厚度、组织布置、和/或组织的材料特性。夹持期间的多个传感器3208a-3208d的基于时间的检测允许处理器(例如,主处理器2006)利用算法和查找表来识别组织特性和夹持位置并且动态地调整端部执行器3200和/或夹持在砧座3202与钉仓3206之间的组织。
图63为逻辑图,其示出了用于基于多个传感器3208a-3208d来确定一个或多个组织特性的方法3220的一个方面。在一个方面,多个传感器3208a-3208d产生表征端部执行器3200的一个或多个参数的多个信号(步骤3222a-3222d)。将多个产生的信号转换成数字信号(步骤3224a-3224d)并且提供给处理器。例如,在包括多个应变仪的一个方面,多个电子μStrain(微应变)转换电路将应变仪信号转换成数字信号(步骤3224a-3224d)。将数字信号提供给处理器,例如,主处理器2006。主处理器2006基于所述多个信号来确定一个或多个组织特性(步骤3226)。主处理器2006可通过应用算法和/或查找表来确定一个或多个组织特性。将一个或多个组织特性通过例如嵌入在外科器械10中的显示器2026显示给操作者(步骤3026)。
图64示出了包括联接到钳口构件3254的多个第二传感器3260a-3260d的端部执行器3250的一个方面。端部执行器3250包括能够枢转地联接到钳口构件3254的砧座3252。砧座3252能够相对于钳口构件3254运动以在两者间夹持一种或多种材料,诸如,组织节段3264。钳口构件3254被构造成能够接收钉仓3256。第一传感器3258联接到砧座3252。第一传感器被配置成能够检测端部执行器3150的一个或多个参数,例如,砧座3252与钉仓3256之间的间隙3110。间隙3110可对应于例如夹持在砧座3252和钉仓3256之间的组织的厚度。第一传感器3258可包括任何合适的传感器,以用于检测端部执行器的一个或多个参数。例如,在各个方面,第一传感器3258可包括磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器。
多个第二传感器3260a-3260d联接到钳口构件3254。多个第二传感器3260a-3260d可与钳口构件3254和/或钉仓3256一体地形成。例如,在一个方面,多个第二传感器3260a-3260d设置在钉仓3256的外侧排上(参见图63)。多个第二传感器3260a-3260d被配置成能够检测端部执行器3250和/或夹持在砧座3252与钉仓3256之间的组织节段3264的一个或多个参数。多个第二传感器3260a-3260d可包括用于检测端部执行器3250和/或组织节段3264的一个或多个参数的任何合适的传感器,例如,磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器或者它们的组合。多个第二传感器3260a-3260d可包括相同的传感器和/或不同的传感器。
在一些方面,多个第二传感器3260a-3260d包括两用传感器和组织稳定元件。多个第二传感器3260a-3260d包括电极和/或感测几何结构,该电极和/或感测几何结构被配置成能够当多个第二传感器3260a-3260d例如在夹持操作期间与组织节段3264时产生稳定组织状态。在一些方面,多个第二传感器3260a-3260d中的一个或多个可由非感测组织稳定元件替换。第二传感器3260a-3260d通过控制夹持、缝合、和/或其它处理过程期间的组织流动、钉变形、和/或其它组织状态来产生稳定组织状态。
图65示出了钉仓3270的一个方面,该钉仓包括一体地形成于其中的多个传感器3272a-3272h。钉仓3270包括多个排,所述多个排容纳多个孔以用于在其中存储钉。外侧排3278中的一个或多个孔由多个传感器3272a-3272h中的一个替换。剖面部分3274被示出以图解说明联接到传感器线3276b的传感器3272f。传感器线3276a、3276b可包括多个线以用于将多个传感器3272a-3272h联接到外科器械(例如,外科器械10)的一个或多个电路。在一些方面,多个传感器3272a-3272h中的一个或多个包括两用传感器和组织稳定元件,该两用传感器和组织稳定元件具有被配置成能够提供组织稳定的电极和/或感测几何结构。在一些方面,多个传感器3272a-3272h可由多个组织稳定元件替换和/或占据。可通过例如夹持和/或缝合期间的组织流动和/或钉成形来提供组织稳定。多个传感器3272a-3272h将信号提供给外科器械10的一个或多个电路,以增强缝合性能和/或组织厚度感测的反馈。
图66为逻辑图,其示出了用于确定夹持在端部执行器(例如,图64中所示的端部执行器3250)内的组织节段3264的一个或多个参数的方法3280的一个方面。在一个方面,第一传感器3258被配置成能够检测端部执行器3250和/或定位在砧座3252与钉仓3256之间的组织节段3264的一个或多个参数。通过第一传感器3258产生第一信号(步骤3282)。第一信号表征由第一传感器3258检测的一个或多个参数。一个或多个第二传感器3260被配置成能够检测端部执行器3250和/或组织节段3264的一个或多个参数。如同第一传感器3258,第二传感器3260可被配置成能够检测相同的参数、附加的参数、或不同的参数。通过第二传感器3260产生第二信号3284。第二信号3284表征由第二传感器3260检测的一个或多个参数。将第一信号和第二信号提供给处理器,例如,主处理器2006。主处理器2006基于由第二传感器3260产生的输入来调整由第一传感器3258产生的第一信号(步骤3286)。调整的信号可表征例如组织节段3264的真实厚度和咬合完全性。将调整的信号通过例如嵌入在外科器械10中的显示器2026显示给操作者(步骤3026)。
图67示出了包括磁性传感器3358的端部执行器3350的一个方面,该磁性传感器具有特定采样率以限制或消除假信号。端部执行器3350包括能够枢转地联接到钳口构件3354的砧座、砧座3352。钳口构件3354被构造成能够在其中接收钉仓3356。钉仓3356包括多个钉,所述多个钉可被递送到定位在砧座3352与钉仓3356之间的组织节段。磁性传感器3358联接到砧座3352。磁性传感器3358被配置成能够检测端部执行器3350的一个或多个参数,诸如,砧座3352与钉仓3356之间的间隙3364。间隙3364可对应于材料(例如,组织节段)的厚度和/或定位在砧座3352与钉仓3356之间的材料的咬合完全性。磁性传感器3358可包括用于检测端部执行器3350的一个或多个参数的任何合适的传感器,诸如,磁性传感器(诸如霍尔效应传感器)、应变仪、压力传感器、电感传感器(诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其它合适的传感器。
在一个方面,磁性传感器3358包括磁性传感器,该磁性传感器被配置成能够检测由联接到钳口构件3354和/或钉仓3356的电磁源3360产生的磁场。电磁源3360产生被磁性传感器3358检测的磁场。检测到的磁场的强度可对应于例如定位在砧座3352和钉仓3356之间的组织的厚度和/或咬合完全性。在一些方面,电磁源3360产生已知频率(例如,1MHz)的信号。在其它方面,由电磁源3360产生的磁场可基于例如安装在钳口构件3354中的钉仓3356的类型、一个或多个附加传感器、算法、和/或一个或多个参数来进行调整。
在一个方面,信号处理器3362联接到端部执行器3350,诸如,砧座3352。信号处理器3362被配置成能够处理由磁性传感器3358产生的信号,以消除假信号并且增强来自磁性传感器3358的输入。在一些方面,信号处理器3362可被定位成独立于端部执行器3350,诸如,定位在外科器械10的柄部组件14中。在一些方面,信号处理器3362与由通用处理器(诸如,主处理器2006)执行的算法一体地形成并且/或者包括该算法。信号处理器3362被配置成能够处理来自磁性传感器3358的特定频率的信号,该频率基本上等于由电磁源3360产生的信号的频率。例如,在一个方面,电磁源3360产生1MHz频率的信号。通过磁性传感器3358检测信号。磁性传感器3358产生信号,该信号表征提供给信号处理器3362的检测到的磁场。该信号由信号处理器3362在1MHz的频率下进行处理以消除假信号。将处理的信号提供给处理器,例如,主处理器2006。主处理器2006使接收到的信号与端部执行器3350的一个或多个参数(诸如,砧座3352与钉仓3356的间隙3364)相关联。
图68为逻辑图,其示出了用于产生定位在端部执行器(诸如,图45中所示的端部执行器3350)的砧座和钉仓之间的组织节段的厚度测量结果的方法3370的一个方面案。在方法3370的一个方面中,通过调制的电磁源3360产生信号(步骤3372)。产生的信号可包括例如1MHz信号。磁性传感器3358被配置成能够检测3374由电磁源3360产生的信号。磁性传感器3358产生指示检测到的磁场的信号并且将信号提供给信号处理器3362。信号处理器3362处理所述信号(步骤3376)以去除噪音、假信号并且/或者增强所述信号。将处理的信号提供给模数转换器以用于转换成数字信号(步骤3378)。例如,可以通过应用校准曲线输入算法和/或查找表来执行数字信号的校准3380。处理(步骤3376)、转换(步骤3378)、和校正(步骤3380)可由一个或多个电路来执行。将校正的信号通过例如与外科器械10一体地形成的显示器2026显示给用户(步骤3026)。
图69A至图69B示出了包括压力传感器的端部执行器3800的一个方面。端部执行器3800包括能够枢转地联接到钳口构件3804的砧座、砧座3802。钳口构件3804被构造成能够在其中接收钉仓3806。钉仓3806包括多个钉。第一传感器3808在远侧末端处联接到砧座3802。第一传感器3808被配置成能够检测端部执行器的一个或多个参数,例如,砧座3802与钉仓3806之间的距离或间隙3814。第一传感器3808可包括任何合适的传感器,例如,磁性传感器。磁体3810可联接到钳口构件3804和/或钉仓3806以将磁信号提供给磁性传感器。
在一些方面,端部执行器3800包括第二传感器3812。第二传感器3812被配置成能够检测端部执行器3800和/或定位在其间的组织节段的一个或多个参数。第二传感器3812可包括任何合适的传感器,例如,一个或多个压力传感器。第二传感器3812可联接到砧座3802、钳口构件3804、和/或钉仓3806。来自第二传感器3812的信号可用于调整第一传感器3808的测量结果,以调整第一传感器的读数,由此精确地表示近侧和/或远侧定位的部分咬合的真实压缩组织厚度。在一些方面,第二传感器3812可相对于第一传感器3808为替代品。
在一些方面,第二传感器3812可包括例如单个连续压力感测膜和/或一系列压力感测膜。第二传感器3812沿中心轴线联接到钉仓3806的平台,从而覆盖如被构造成能够接收切割和/或钉部署构件的狭槽3816。第二传感器3812提供信号,该信号指示夹持操作期间由组织施加的压力的幅值。在切割和/或部署构件的击发期间,可例如通过切割第二传感器3812与一个或多个电路之间的电连接来切断来自第二传感器3812的信号。在一些方面,第二传感器3812的切断电流可表征用尽的钉仓3806。在其它方面,第二传感器3812可被定位成使得切割和/或部署构件的部署不切断第二传感器3812的连接。
图70示出了端部执行器3850的一个方面,该端部执行器包括定位在钉仓3806和钳口构件3804之间的第二传感器3862。端部执行器3850包括能够枢转地联接到钳口构件3854的砧座、砧座3852。钳口构件3854被构造成能够在其中接收钉仓3856。第一传感器3858联接到砧座3852的远侧末端处。第一传感器3858被配置成能够检测端部执行器3850的一个或多个参数,例如,砧座3852与钉仓3856之间的距离或间隙3864。第一传感器3858可包括任何合适的传感器,诸如,磁性传感器。磁体3860可联接到钳口构件3854和/或钉仓3856以将磁信号提供给磁性传感器。在一些方面,端部执行器3850包括第二传感器3862,该第二传感器除了定位在钉仓3856与钳口构件3854之外在所有方面均类似于图69A至图69B的第二传感器3812。
图71为逻辑图,其示出了用于确定和显示被夹持在根据图69A至图69B或图70的端部执行器3800或3850中的组织节段的厚度的方法3870的一个方面。该方法包括通过例如定位在砧座3802的远侧末端处的霍尔效应传感器获得霍尔效应电压3872。将霍尔效应电压3872提供给模数转换器3876并且转换成数字信号。将数字信号提供给处理器,诸如,主处理器2006。主处理器2006校正霍尔效应电压3872信号的曲线输入(步骤3874)。压力传感器(例如,第二传感器3812)被配置成能够测量例如端部执行器3800的一个或多个参数(步骤3880),诸如,由砧座3802施加到夹持在端部执行器3800中的组织上的压力的量。在一些方面,压力传感器可包括单个连续压力感测膜和/或一系列压力感测膜。压力传感器可因而能够操作以确定端部执行器3800的近侧端部和远侧端部之间的不同位置处的测量压力的变化。将所测量的压力提供给处理器,例如,主处理器2006。主处理器2006响应于由压力传感器3880测量的压力来利用一个或多个算法和/或查找表调整霍尔效应电压3872(步骤3882),以较精确地反映夹持在例如砧座3802与钉仓3806之间的组织的厚度。将调整的厚度通过例如嵌入在外科器械10中的显示器2026显示给操作者(步骤3878)。
图72示出了端部执行器3900的一个方面,该端部执行器包括定位在钉仓3906和细长通道3904之间的多个第二传感器3192a-3192b。端部执行器3900包括能够枢转地联接到钳口构件或细长通道3904的砧座3902。细长通道3904被构造成能够在其中接收钉仓3906。砧座3902还包括位于远侧末端中的第一传感器3908。第一传感器3908被配置成能够检测端部执行器3900的一个或多个参数,例如,砧座3902与钉仓3906之间的距离或间隙。第一传感器3908可包括任何合适的传感器,诸如,磁性传感器。磁体3910可联接到细长通道3904和/或钉仓3906以将磁信号提供给第一传感器3908。在一些方面,端部执行器3900包括位于钉仓3906与细长通道3904之间的多个第二传感器3912a-3912c。第二传感器3912a-3912c可包括任何合适的传感器,例如,压阻型压力膜条。在一些方面,第二传感器3912a-3912c可均匀地分布在端部执行器3900的远侧端部和近侧端部之间。
在一些方面,可利用来自第二传感器3912a-3912c的信号调整第一传感器3908的测量结果。例如,可利用来自第二传感器3912a-3912c的信号调整第一传感器3908的读数以精确地表示砧座3902与钉仓3906之间的间隙,该间隙可在端部执行器3900的远侧端部和近侧端部之间有所变化,这取决于砧座3902与钉仓3906之间的组织3920的位置和/或密度。图11示出了组织3920的部分咬合的示例。如针对此示例的目的所示,组织仅定位在端部执行器3900的近侧区域中,由此产生位于端部执行器3900的近侧区域附近的高压力区域3918和位于端部执行器的远侧端部附近的相应低压力区域3916。
图73A和图73B进一步示出了组织3920的完全咬合相对于部分咬合的效果。图73A示出了具有组织3920的完全咬合的端部执行器3900,其中组织3920具有均匀密度。在具有均匀密度的组织3920的完全咬合的情况下,端部执行器3900处的远侧末端处的测得第一间隙3914a可大体等于端部执行器3900的中部或近侧端部中的测得第二间隙3922a。例如,第一间隙3914a可测得为2.4mm,并且第二间隙可测得为2.3mm。图73B示出了具有组织3920的部分咬合或另选地具有不均匀密度的组织3920的完全咬合的端部执行器3900。在这种情况下,第一间隙3914b将测得为小于在组织3920的最厚或最致密部分处测得的第二间隙3922b。例如,第一间隙可测得为1.0mm,而第二间隙可测得为1.9mm。在图73A至图73B所示的情况下,来自第二传感器3912a-3912c的信号(诸如,沿端部执行器3900的长度的不同点处的测得压力)可被器械用于确定组织3920的布置和/或组织3920的材料特性。器械还可操作以利用随时间变化的测得压力识别组织特性和组织位置并且动态地调整组织厚度测量结果。
图74示出了端部执行器4050的方面,该端部执行器被配置成能够确定切割构件或刀4062的位置。端部执行器4050包括能够枢转地联接到钳口构件或细长通道4054的砧座4052。细长通道4054被构造成能够在其中接收钉仓4056。钉仓4056还包括狭槽(未示出)和定位在其中的切割构件或刀4062。刀4062能够操作地联接到刀杆4064。刀杆4064能够操作以将刀4062从狭槽的近侧端部移动到远侧端部。端部执行器4050还可包括定位在狭槽的近侧端部附近的光学传感器4060。光学传感器可联接到处理器,例如,主处理器2006。光学传感器4060可操作以朝刀杆4064发射光信号。刀杆4064还可包括沿其长度的编码条4066。编码条4066可包括切口、凹口、反射件、或光学可读的任何其它构型。编码条4066被布置成使得来自光学传感器4060的光信号从编码条4066反射或者穿过编码条4066。当刀4062运动并且刀杆4064沿狭槽4058运动4068时,光学传感器4060将检测联接到编码条4066的所发射的光信号的反射。光学传感器4060可操作以将所检测的信号发送给主处理器2006。主处理器2006可被配置成能够利用所检测的信号确定刀4062的位置。可通过设计编码条4066以使得所检测的光信号具有渐变增加和降低来更精确地感测刀4062的位置。
图75示出了与红色LED 4070和红外LED 4072一起操作的编码条4066的示例。仅为了此示例的目的,编码条4066包括切口。当编码条4066运动4068时,由红色LED 4070发射的光将随着切口在其前面通过而被中断。红外LED 4072将因此检测到编码条4066的运动,并且因此通过引申可检测到刀4062的运动。
图76示出了外科器械10的端部执行器300的局部视图。在图76所示的示例形式中,端部执行器300包括钉仓1100,该钉仓在许多方面类似于外科钉仓304(图15)。端部执行器300的若干部分被省略以允许更清楚地理解本公开。在某些情况下,端部执行器300可包括第一钳口(例如,砧座306(图20))和第二钳口(诸如,细长通道198(图14))。在某些情况下,如上所述,细长通道198可容纳钉仓,例如,外科钉仓304或钉仓1100。细长通道198和砧座306中的至少一者可相对于细长通道198和砧座306中的另一者运动以将组织捕集在钉仓1100与砧座306之间。本文描述了各种致动组件以有利于细长通道198和/或砧座306例如在打开构型(图1)和闭合构型(图77)之间的运动。
在某些情况下,如上所述,可朝远侧推进E形横梁178,以将钉191部署到所捕集的组织内,并且/或者在多个位置之间推进切割边缘182以接合和切割所捕集的组织。如图76所示,可例如沿由狭槽193限定的路径朝远侧推进切割边缘182。在某些情况下,可将切割边缘182从钉仓1100的近侧部分1103推进到钉仓1100的远侧部分1105以切割所捕集的组织。在某些情况下,可例如通过朝近侧回缩E形横梁178来使切割边缘182从远侧部分1105朝近侧回缩到近侧部分1103。
在某些情况下,可采用切割刃182以在多个手术中切割由端部执行器300捕集的组织。读者将会知道,切割刃182的重复使用可影响切割刃182的锐度。读者还将会知道,当切割刃182的锐度降低时,利用切割刃182切割捕集的组织所需的力可增加。参见图78至图83,在某些情况下,外科器械10可包括电路1106(图78)以用于例如在外科手术中在外科器械10的操作期间、之前、和/或之后监测切割边缘182的锐度。在某些情况下,可在利用切割边缘182切割所捕集的组织之前采用电路1106来测试切割边缘182的锐度。在某些情况下,可在切割边缘182已用于切割所捕集的组织之后采用电路1106来测试切割边缘182的锐度。在某些情况下,可在切割边缘182用于切割所捕集的组织之前和之后采用电路1106来测试切割边缘182的锐度。在某些情况下,可在近侧部分1103处和/或远侧部分1105处采用电路1106来测试切割边缘182的锐度。
参见图78至图83,电路1106可以包括一个或多个传感器,例如,光学传感器1108;例如,电路1106的光学传感器1108可用于测试切割边缘182的反射能力。在某些情况下,切割刃182反射光的能力可与切割刃182的锐度相关联。换句换讲,切割刃182的锐度降低可导致切割刃182反射光的能力降低。因此,在某些情况下,可例如通过检测从切割刃182反射的光的强度来评估切割刃182的钝度。在某些情况下,光学传感器1108可限定光感测区域。光学传感器1108可例如被取向成使得光感测区设置在切割刃182的路径中。当切割刃182例如位于光感测区中时,可采用光学传感器1108来感测从切割刃182反射的光。反射光的强度降低到阈值之下可指示切割刃182的锐度已降低到可接受水平之下。
再次参见图78-83,电路1106可包括一个或多个光源,诸如,光源1110。在某些情况下,电路1106可包括控制器1112(“微控制器”),该控制器可操作地联接到光学传感器1108,如图78至图83所示。在某些情况下,控制器1112可包括处理器1114(“微处理器”)和一个或多个计算机可读介质或存储器1116(“存储单元”)。在某些情况下,存储器1116可存储各种程序指令,所述各种程序指令在执行时可使得处理器1114执行本文所述的多个功能和/或计算。在某些情况下,存储器1116可例如联接到处理器1114。电源1118可被配置成能够例如将功率提供给控制器1112、光学传感器1108、和/或光源1110。在某些情况下,电源1118可包括电池(或者“电池组”或“电源组”),例如,锂离子电池。在某些情况下,电池组可被构造成能够可释放地安装到柄部组件14以用于将功率供应给外科器械10。可将多个串联的电池单元用作电源4428。在某些情况下,电源1118可为例如可更换的和/或可充电的。
控制器1112和/或本公开的其它控制器可使用集成的和/或分立的硬件元件、软件元件和/或该硬件元件和软件元件两者的组合来实现。集成硬件元件的示例可包括处理器、微处理器、控制器、集成电路、ASIC、PLD、DSP、FPGA、逻辑门、寄存器、半导体器件、芯片、微芯片、芯片组、控制器、SoC、和/或SIP。分立硬件元件的示例可包括电路和/或电路元件,诸如逻辑门、场效应晶体管、双极型晶体管、电阻器、电容器、电感器和/或继电器。在某些情况下,例如,控制器1112可包括混合电路,该混合电路在一个或多个基板上包括分立的和集成的电路元件或部件。在某些情况下,如结合图14至图17B描述的,本公开的控制器1112和/或其它控制器可以是单核或多核控制器LM4F230H5QR。
在某些情况下,光源1110可用于发射光,所述光可例如被引导到光感测区中的切割刃182处。光学传感器1108可用于响应暴露于由光源1110发射的光来测量从处于光感测区中的切割刃182反射的光的强度。在某些情况下,处理器1114可接收反射光的测量强度的一个或多个值并且可将反射光的测量强度的一个或多个值存储在例如存储器1116上。存储值可在例如由外科器械10执行的外科手术之前、之后、和/或期间来检测和/或记录。
在某些情况下,处理器1114可将反射光的测量强度与例如可存储在存储器1116上的预定义阈值进行比较。在某些情况下,如果所测量的光强度超过预定义阈值例如1%、5%、10%、25%、50%、100%和/或多于100%,则控制器1112可断定切割刃182的锐度已下降到低于可接受水平。在某些情况下,处理器1114可用于检测从处于光感测区的切割刃182反射的光的测量强度的存储值的下降趋势。
在某些情况下,外科器械10可包括一个或多个反馈系统,例如,反馈系统1120。在某些情况下,如果从处于光感测区的切割刃182反射的光的测量光强度超过例如存储阈值,则处理器1114可采用反馈系统1120来警示用户。在某些情况下,反馈系统1120可包括例如一个或多个视觉反馈系统,例如,显示屏、背光源、和/或LED。在某些情况下,反馈系统1120可包括例如一个或多个听觉反馈装置,诸如,扬声器和/或蜂鸣器。在某些情况下,反馈系统1120可包括例如一个或多个触觉反馈系统。在某些情况下,反馈系统1120可包括例如视觉反馈系统、听觉反馈系统、和/或触觉反馈系统的组合。
在某些情况下,外科器械10可包括击发闭锁机构1122,该击发闭锁机构可用于阻止切割刃182的推进。各种合适的击发闭锁机构更详细地描述于名称为“FIRING SYSTEMLOCKOUT ARRANGEMENTS FOR SURGICAL INSTRUMENTS”的美国专利公开2014/0001231中,该专利申请的公开内容全文以引用方式并入本文。在某些情况下,如图78所示,处理器1114可以可操作地联接到击发闭锁机构1122;如果确定从切割边缘182反射的光的测量强度超过例如存储阈值,则处理器1114可采用击发闭锁机构1122来阻止切割边缘182的推进。换句话讲,如果切割边缘不足够锐利以切割由端部执行器300捕集的组织,则处理器1114可启动击发闭锁机构1122。
在某些情况下,光学传感器1108和光源1110可容纳在可互换轴组件200的远侧部分处。在某些情况下,如上所述,可在切割边缘182过渡到端部执行器300内之前,通过光学传感器1108评估切割边缘182的锐度。当例如切割边缘182处于可互换轴组件182中时并且在进入端部执行器300之前,击发杆172(图14)可推进切割边缘200穿过由光学传感器1108限定的光感测区。在某些情况下,可在切割刃182从端部执行器300朝近侧回缩之后通过光学传感器1108评估切割刃182的锐度。当例如切割边缘182从端部执行器300回缩到可互换轴组件200内之后,击发杆172(图14)可回缩切割边缘182穿过由光学传感器1108限定的光感测区。
在某些情况下,光学传感器1108和光源1110可容纳在例如端部执行器300的近侧部分处,该近侧部分可位于钉仓1100的近侧。可例如在切割边缘182过渡到端部执行器300内之后但在接合钉仓1100之前,通过光学传感器1108评估切割边缘182的锐度。在某些情况下,当例如切割边缘182处于端部执行器300时但在接合钉仓1100之前,击发杆172(图14)可推进切割边缘182穿过由光学传感器1108限定的光感测区。
在各种情况下,可在切割刃182由击发杆172推进穿过狭槽193时通过光学传感器1108评估切割刃182的锐度。如图78至图83所示,光学传感器1108和光源1110可以容纳在例如钉仓1100的近侧部分1103中;可通过例如近侧部分1103处的光学传感器1108评估切割边缘182的锐度。击发杆172(图14)可例如在切割边缘182接合捕集在钉仓1100与砧座306之间的组织之前推进切割边缘182穿过由近侧部分1103处的光学传感器1108限定的光感测区。在某些情况下,如图78至图83所示,光学传感器1108和光源1110可容纳在例如钉仓1100的远侧部分1105处。可通过远侧部分1105处的光学传感器1108评估切割边缘182的锐度。在某些情况下,击发杆172(图14)可例如在切割边缘182已穿过捕集在钉仓1100与砧座306之间的组织之后推进切割边缘182穿过由远侧部分1105处的光学传感器1108限定的光感测区。
再次参见图76,钉仓1100可包括例如多个光学传感器1108和多个对应光源1110。在某些情况下,一对光学传感器1108和光源1110可容纳在例如钉仓1100的远侧部分1103处;并且一对光学传感器1108和光源1110可容纳在例如钉仓1100的近侧部分1105处。在此类情况下,切割边缘182的锐度可例如在接合组织之前在近侧部分1103处进行第一次评估,并且例如在穿过所捕集的组织之后在远侧部分1105处进行第二次评估。
读者将会知道,光学传感器1108可在外科手术期间多次地评估切割刃182的锐度。例如,切割刃的锐度可例如在击发行程中在切割刃182推进穿过狭槽193期间进行第一次评估,并且例如在返回行程中在切割刃182回缩穿过狭槽193期间进行第二次评估。换句话讲,从切割边缘182反射的光可例如在切割边缘推进穿过光感测区时由光学传感器1108测量一次并且在切割边缘182回缩穿过光感测区时测量一次。
读者将会知道,处理器1114可从光学传感器1108中的一个或多个接收从切割刃182反射的光的强度的多个读数。在某些情况下,处理器1114可被配置成能够例如忽略异常值并且计算来自多个读数的平均读数。在某些情况下,可将平均读数与例如存储器1116中的阈值进行比较。在某些情况下,处理器1114可被配置成能够例如在确定所计算的平均读数超过存储在存储器1116中的阈值的情况下通过反馈系统1120警示用户和/或启动闭锁机构1122。
在某些情况下,如图77、图79、和图80所示,一对光学传感器1108和光源1110可定位在钉仓1100的相对侧。换句换讲,光学传感器1108可定位在例如狭槽193的第一侧1124,并且光源1110可定位在例如狭槽193的第二侧1126(与第一侧1124相对)。在某些情况下,所述对光学传感器1108和光源1110可基本上设置在横断钉仓1100的平面上,如图77所示。所述对光学传感器1108和光源1110可被取向成限定光感测区,该光感测区例如定位在或至少基本上定位在横断钉仓1100的平面上。另选地,所述对光学传感器1108和光源1110可被取向成限定光感测区,该光感测区例如定位在横断钉仓1100的平面的近侧,如图80所示。
在某些情况下,一对光学传感器1108和光源1110可定位在钉仓1100的同一侧。换句换讲,如图81所示,当切割边缘182推进穿过狭槽193时,所述对光学传感器1108和光源1110可定位在切割边缘182的第一侧,例如,侧面1128。在此种情况下,光源1110可以被取向成在切割边缘182的侧面1128处引导光;并且由光学传感器1108测量的从侧面1128反射的光的强度可以表示侧面1128的锐度。
在某些情况下,如图82所示,第二对光学传感器1108和光源1110可定位在例如切割边缘182的第二侧,例如,侧面1130。所述第二对可用于评估侧面1130的锐度。例如,第二对光源1110可以被取向成在切割边缘182的侧面1130处引导光;并且由第二对光学传感器1108测量的从侧面1130反射的光的强度可以表示侧面1130的锐度。在某些情况下,处理器可被配置成能够例如基于从切割刃182的侧面1128和1130反射的光的测得强度来评价切割刃182的锐度。
在某些情况下,如图77所示,一对光学传感器1108和光源1110可容纳在钉仓1100的远侧部分1105处。如图81所示,光学传感器1108可例如定位在或至少基本上定位在轴线LL上,该轴线LL沿切割边缘182穿过狭槽193的路径纵向地延伸。此外,光源1110可例如定位在切割刃182的远侧并且被取向成在切割刃朝光源1110推进时将光引导到切割刃182处。此外,光学传感器1108可定位在或至少基本上定位在与轴线LL相交的轴线AA上,如图81所示。在某些情况下,轴线AA可例如垂直于轴线LL。在任何情况下,光学传感器1108可被取向成将光感测区限定在例如轴线LL与轴线AA的交点处。
读者将会知道,本文所述的与外科器械10结合的光学传感器和对应光源的位置、取向、和/或数目为旨在用于举例说明目的的示例性方面。本公开可采用光学传感器和光源的各种其它布置方式来评估切割刃182的锐度。
读者将会知道,在外科器械10的每次击发期间,切割刃182推进穿过由端部执行器300捕集的组织可导致切割刃聚集组织碎屑和/或体液。此类碎屑可干扰回路1106精确地评估切割边缘182的锐度的能力。在某些情况下,外科器械10可配备有一个或多个清洁机构,该清洁机构可用于例如在评估切割刃182的锐度之前清洁切割刃182。
参见图76,在某些情况下,钉仓1100可包括例如可容纳在钉仓1100的近侧部分1103中的第一对光学传感器1108和光源1110。此外,如图76所示,钉仓1100可包括可在近侧部分1103中容纳在狭槽193的相对侧面上的第一对清洁构件1132。第一对清洁构件1132可例如定位在第一对光学传感器1108和光源1110的远侧。如图76所示,钉仓1100可包括例如可容纳在钉仓1100的远侧部分1105中的第二对光学传感器1108和光源1110。如图76所示,钉仓1100可包括可在远侧部分1105中容纳在狭槽193的相对侧面上的第二对清洁构件1132。第二对清洁构件1132可定位在第二对光学传感器1108和光源1110的近侧。
除上述之外,如图76所示,切割边缘182可在击发行程中朝远侧推进以切割由端部执行器300捕集的组织。当切割边缘推进时,可例如在切割边缘182与组织接合之前,通过第一对光学传感器1108和光源1110进行切割边缘182的锐度的第一评估。可例如在切割刃182已横切所捕集的组织之后,通过第二对光学传感器1108和光源1110进行切割刃182的锐度的第二评估。切割刃182可在切割刃182的锐度的第二评估之前推进穿过第二对清洁构件1132,以移除由切割刃182在所捕集的组织的横切期间聚集的任何碎屑。
除上述之外,如图76所示,切割边缘182可在返回行程中朝近侧回缩。当切割边缘回缩时,可在返回行程期间通过第一对光学传感器1108和光源1110进行切割边缘182的锐度的第三评估。切割刃182可例如在切割刃182的锐度的第三评估之前推进穿过第一对清洁构件1132,以移除由切割刃182在所捕集的组织的横切期间聚集的任何碎屑。
在某些情况下,光源1110中的一个或多个可包括一个或多个光纤缆线。在某些情况下,一个或多个挠性电路1134可用于将来自电源1118的能量传输到光学传感器1108和/或光源1110。在某些情况下,挠性电路1134可被配置成能够例如将光学传感器1108的读数中的一个或多个传输到控制器1112。
现在参见图84,示出了钉仓4300。钉仓4300在许多方面类似于外科钉仓304(图14)。例如,钉仓4300可与端部执行器300一起使用。在某些情况下,如图84所示,钉仓4300可包括锐度测试构件4302,该锐度测试构件可用于测试切割刃182的锐度。在某些情况下,锐度测试构件4302可例如附接到钉仓4300的仓体194和/或与其形成一体。在某些情况下,锐度测试构件4302可设置在例如钉仓4300的近侧部分1103中。在某些情况下,如图84所示,锐度测试构件4302可设置在例如钉仓4300的仓平台4304上。
在某些情况下,如图84所示,锐度测试构件4302可例如延伸横跨钉仓4300的狭槽193,以桥接或至少部分地桥接由狭槽193限定的间隙。在某些情况下,锐度测试构件4302可中断或至少部分地中断切割刃182的路径。当切割刃182例如在击发行程期间推进时,切割刃182可接合、切割、和/或穿过锐度测试构件4302。在某些情况下,切割刃182可被构造成能够例如在击发行程中在接合由端部执行器300捕集的组织之前接合、切割、和/或穿过锐度测试构件4302。在某些情况下,切割刃182可被构造成能够例如在锐度测试构件4302的近侧端部4306处接合锐度测试构件4302,并且在锐度测试构件4302的远侧端部4308处离开和/或脱离锐度测试构件4302。在某些情况下,当切割刃182在击发行程期间推进时,切割刃182可例如穿过锐度测试构件4302在近侧端部4306与远侧端部4308之间行进和/切割距离(D)。
主要参见图84和图85,外科器械10可包括例如用于测试切割边缘182的锐度的回路4310。在某些情况下,回路4310可通过测试切割边缘182推进穿过锐度测试构件4302的能力来评估切割边缘182的锐度。例如,回路4310可被配置成能够观测切割边缘182完全横切和/或完全穿过锐度测试构件4302的至少预先确定的部分所需要的时间段。如果所观测的时间段超过预定义阈值,则电路4310可断定例如切割边缘182的锐度已下降到低于可接受水平。
在某些情况下,回路4310可包括控制器4312(“微控制器”),该控制器可包括处理器4314(“微处理器”)和一个或多个计算机可读介质或存储单元4316(“存储器”)。在某些情况下,存储器4316可存储各种程序指令,这些各种程序指令在执行时可使得处理器4314执行本文描述的多个功能和/或计算。在某些情况下,存储器4316可例如联接到处理器4314。电源4318可被配置成能够例如将功率供应给控制器4312。在某些情况下,电源4138可包括电池(或者“电池组”或“电源组”),例如,锂离子电池。在某些情况下,电池组可被构造成能够可释放地安装到柄部组件14。可将多个串联的电池单元用作电源4318。在某些情况下,电源4318可为例如可更换的和/或可充电的。
在某些情况下,控制器4313可操作地联接到例如反馈系统1120和/或击发闭锁机构1122。
参见图84和图85,回路4310可包括一个或多个位置传感器。适合与本公开一起使用的示例位置传感器和定位系统在名称为“SENSOR ARRANGEMENTS FOR ABSOLUTEPOSITIONING SYSTEM FOR SURGICAL INSTRUMENTS”的美国专利申请序列公开2014/0263538中有所描述,该专利申请的公开内容全文以引用方式并入本文。在某些情况下,回路4310可包括第一位置传感器4320和第二位置传感器4322。在某些情况下,第一位置传感器4320可用于检测例如锐度测试构件4302的近侧端部4306处的切割边缘182的第一位置;并且第二位置传感器4322可用于检测例如锐度测试构件4302的远侧端部4308处的切割边缘182的第二位置。
在某些情况下,第一和第二位置传感器4320、4322可用于分别将第一位置信号和第二位置信号提供给控制器4312。应当理解,位置信号可为模拟信号或数字值,这取决于控制器4312与第一和第二位置传感器4320和4322之间的接口。在一个方面,控制器4312与第一和第二位置传感器4320和4322之间的接口可为标准串行外围设备接口(SPI),并且位置信号可为表示切割边缘182的第一位置和第二位置的数字值,如上所述。
除上述之外,处理器4314可确定接收第一位置信号与接收第二位置信号之间的时间段。所确定的时间段可对应于切割刃182从例如锐度测试构件4302的近侧端部4306处的第一位置到例如锐度测试构件4302的远侧端部4308处的第二位置推进穿过锐度测试构件4302所需要的时间。在至少一个示例中,控制器4312可包括时间元件,该时间元件可在接收到第一位置信号时由处理器4314启动并且可在接收到第二位置信号时停用。时间元件的启动和停用之间的时间段可对应于例如切割刃182从第一位置推进到第二位置所需要的时间。时间元件可包括实时时钟、被配置成能够实现计时功能的处理器、或任何其它合适的计时电路。
在各种情况下,控制器4312可例如将切割刃182从第一位置推进到第二位置所需要的时间段与预定义阈值进行比较以评价切割刃182的锐度是否已下降到低于可接受水平。在某些情况下,如果所测量的时间段超过预定义阈值例如1%、5%、10%、25%、50%、100%和/或多于100%,则控制器4312可断定切割刃182的锐度已下降到低于可接受水平。
参见图86,在各种情况下,电动马达4330可驱动击发杆172(图14)以例如在击发行程期间推进切割边缘182并且/或者在返回行程期间回缩切割边缘182。马达驱动器4332可以控制电动马达4330;并且控制器(诸如,控制器4312)可以与马达驱动器4332进行信号通信。当电动马达4330推进切割边缘182时,控制器4312可例如确定由电动马达4330消耗的电流。在此类情况下,推进切割刃182所需的力可对应于例如由电动马达4330消耗的电流。仍参见图86,外科器械10的微控制器4312可确定切割边缘182的推进期间由电动马达4330消耗的电流是否增大,并且如果增大,则可计算电流的增量百分比。
在某些情况下,当切割刃182与锐度测试构件4302接触时,由电动马达4330消耗的电流可因锐度测试构件4302对切割刃182的阻力而显著增大。例如,当切割刃182接合、穿过、和/或切穿锐度测试构件4302时,由电动马达4330消耗的电流可显著增大。读者将理解,锐度测试构件4302对切割边缘182的阻力部分地取决于切割边缘182的锐度;并且随着切割边缘182的锐度因重复使用而减小,锐度测试构件4302对切割边缘182的阻力将增加。因此,当切割边缘与锐度测试构件4302接触时由电动马达4330消耗的电流的增量百分比的值可例如随着切割边缘182的锐度因重复使用造成的降低而增大。
在某些情况下,所确定的由电动马达4330消耗的电流的增量百分比的值可为由电动马达4330消耗的电流的最大检测增量百分比。在各种情况下,控制器4312可将所确定的由电动马达4330消耗的电流的增量百分比的值与由电动马达4330消耗的电流的增量百分比的预定义阈值进行比较。如果所确定的值超过预定义阈值,则控制器4312可断定例如切割边缘182的锐度已下降到低于可接受水平。
在某些情况下,如图86所示,处理器4314可例如与反馈系统1120和/或击发闭锁机构1122通信。在某些情况下,如果所确定的由电动马达4330消耗的电流的增量百分比的值超过预定义阈值,则处理器4314可例如采用反馈系统1120警示用户。在某些情况下,如果所确定的由电动马达4330消耗的电流的增量百分比的值超过预定义阈值,则处理器4314可例如采用击发闭锁机构1122来阻止切割边缘182的推进。
在各种情况下,控制器4312可利用算法确定由电动马达4330消耗的电流的变化。例如,电流传感器可检测击发行程期间由电动马达4330消耗的电流。电流传感器可连续检测由电动马达消耗的电流,并且/或者可间歇性地检测由电动马达消耗的电流。在各种情况下,算法可比较最新的电流读数与例如紧接进展的电流读数。除此之外或另选地,算法可比较时间段X内的样品读数X与此前的电流读数。例如,算法可比较样品读数与例如此前的时间段X(诸如紧接进展的时间段X)内的样品读数。在其它情况下,算法可计算由马达消耗的电流趋势平均值。算法可计算时间段X期间消耗的平均电流(包括例如最新电流读数),并且可比较消耗的平均电流与例如在紧接进展的时间段X期间消耗的平均电流。
参见图87,其描绘了用于评估外科器械10的切割边缘182的锐度的方法4500;例如,在切割边缘182的锐度下降到和/或低于警示阈值和/或高风险阈值的情况下,概述了各种响应。在各种情况下,控制器(诸如,控制器4312)可被配置成能够实施图85所示的方法。在某些情况下,外科器械10可包括负荷单元4334(图86);如图84所示,控制器4312可以与负荷单元4334通信。在某些情况下,负荷单元4334可包括例如可操作地联接到击发杆172的力传感器,例如,应变仪。在某些情况下,控制器4312可采用负荷单元4334来监测当切割边缘182在击发行程期间推进时施加到切割边缘182的力(Fx)。
因此,当开始刀击发(步骤4502)时,系统通过感测力Fx检查(步骤4504)刀的切割边缘182的钝化。将感测到的力Fx与阈值力F1进行比较,并确定(步骤4506)感测到的力Fx是否大于阈值力F1。当感测到的力Fx小于或等于阈值力F1时,该过程沿“否”分支前进,并且不显示(步骤4508)任何内容并继续(步骤4510)刀击发过程。当感测到的力Fx大于阈值力F1时,该过程沿“是”分支前进,并且确定(步骤4512)感测到的力Fx是否超过高风险阈值力F2。当感测到的力Fx小于或等于阈值F2时,该过程沿“否”分支前进,并且通知(步骤4514)处理器刀的切割边缘182变钝并继续(步骤4510)刀击发过程。当感测到的力Fx大于阈值F2时,该过程沿“是”分支前进,并且通知处理器4516刀的切割边缘182变钝并接合刀击发闭锁。随后,任选地,如果闭锁被覆盖,则处理器可以覆盖(步骤4518)刀击发闭锁并继续(步骤4510)刀击发过程。
参见图88,示出了一种方法4600,该方法用于例如确定切割边缘(例如,切割边缘182)是否足够锐利以用于横切由端部执行器300捕集的具有特定组织厚度的组织。如上所述,切割刃182的重复使用可钝化或降低切割刃182的锐度,由此可增加切割刃182横切所捕集组织所需的力。换句换讲,可例如通过切割刃182横切所捕集组织所需的力来限定切割刃182的锐度水平。读者将会知道,切割刃182横切所捕集组织所需的力还可依赖于所捕集组织的厚度。在某些情况下,例如,在相同的锐度水平下,所捕集组织的厚度越大,则切割刃182横切所捕集组织所需的力也越大。
因此,最初,缝合器将砧座与钳口构件之间的组织夹持(步骤4602)。系统感测(步骤4604)组织厚度Tx并发起(步骤4606)刀击发过程。在发起刀击发过程时,系统感测(步骤4608)来自夹持组织的负载阻力,并将感测的力Fx和感测的厚度Tx与各种阈值进行比较,并基于评估确定(步骤4610)若干结果。在一个方面,当该过程确定(步骤4610)感测的组织厚度Tx是否在第一组织厚度阈值T1与第二组织厚度阈值T2之间限定的第一组织厚度范围内,并且感测的力Fx大于第一力阈值F1,并且该过程确定(步骤4610)感测的组织厚度Tx是否在第二组织厚度阈值T2与第三组织厚度阈值T3之间限定的第二组织厚度范围内,并且感测的力Fx大于第二力阈值F2时,该过程沿“是”分支前进,并且通知(步骤4612)或警告处理器该刀正在钝化,然后继续(步骤4614)刀击发过程。否则,该过程沿“否”分支前进,并且不通知(步骤4616)处理器并继续刀击发过程。一般来讲,该过程确定感测的组织厚度Tx是否在组织厚度阈值Tn与Tn+1之间限定的组织厚度范围内,并且感测的力Fx大于力阈值Tn,其中n表示组织厚度范围。当该过程确定(步骤4610)感测的组织厚度Tx在第一组织厚度阈值T1与第二组织厚度阈值T2之间限定的第一组织厚度范围内,并且感测的力Fx大于第一力阈值F1,并且该过程确定(步骤4610)感测的组织厚度Tx在第二组织厚度阈值T2与第三组织厚度阈值T3之间限定的第二组织厚度范围内,并且感测的力Fx大于第二力阈值F2时,该过程继续。
在某些情况下,例如,切割刃182可足够锐利以横切具有第一厚度的所捕集组织,但可不足够锐利以横切具有大于第一厚度的第二厚度的所捕集组织。在某些情况下,例如,如果所捕集组织具有位于特定组织厚度范围内的组织厚度,则由切割刃182横切所捕集组织所需的力限定的切割刃182的锐度水平可足以横切所捕集组织。
在某些情况下,如图89所示,存储器4316可以存储由端部执行器300捕集的组织的一个或多个预定范围的组织厚度;并且预定义的阈值力与预定范围的组织厚度相关联。在某些情况下,每个预定义阈值力可表示适于横切具有组织厚度(Tx)的所捕集组织的切割刃182的最小锐度水平,该组织厚度(Tx)由与预定义阈值力相关联的组织厚度范围涵盖。在某些情况下,如果切割刃182横切具有组织厚度(Tx)的所捕集组织所需的力(Fx)超过例如与涵盖组织厚度(Tx)的预定义组织厚度范围相关联的预定义阈值力,则切割刃182可不足够锐利以横切所捕集组织。
在某些情况下,可将预定义阈值力及其对应的预定义组织厚度范围存储在存储器4316上的数据库和/或表(诸如,表4342)中,如图89所示。在某些情况下,处理器4314可被配置成能够接收切割刃182横切所捕集组织所需的力(Fx)的测量值以及所捕集组织的组织厚度(Tx)的测量值。处理器4314可访问表4342以确定涵盖所测量的组织厚度(Tx)的预定义组织厚度范围。此外,处理器4314可将所测量的力(Fx)与预定义阈值力进行比较,该预定义阈值力与涵盖组织厚度(Tx)的预定义组织厚度范围相关联。在某些情况下,如果所测量的力(Fx)超过例如预定义阈值力,则处理器4314可断定切割刃182可不足够锐利以横切所捕集组织。
除上述之外,处理器4314(图85、图86)可采用一个或多个组织厚度感测模块(诸如,组织厚度感测模块4336)以确定所捕集组织的厚度。各种合适的组织厚度感测模块在本公开中有所描述。另外,适合与本公开一起使用的各种组织厚度感测装置和方法在名称为“SURGICAL CUTTING INSTRUMENT THAT ANALYZES TISSUE THICKNESS”的美国专利专利申请公开2011/0155781中有所公开,该专利申请的公开内容全文以引用方式并入本文。
在某些情况下,处理器4314可采用负荷单元4334测量切割边缘182横切具有组织厚度(Tx)的所捕集组织所需的力(Fx)。读者将会知道,当切割刃182接合和/或接触所捕集组织时由所捕集组织施加到切割刃182的力可随着切割刃182抵靠所捕集组织推进而增加,直至达到切割刃182可横切所捕集组织的力(Fx)。在某些情况下,当切割边缘182抵靠所捕集组织推进时,处理器4314可采用负荷单元4334连续地监测由所捕集组织抵靠切割边缘182施加的力。处理器4314可连续地比较所监测的力与预定义阈值力,该预定义阈值力与涵盖所捕集组织的组织厚度(Tx)的预定义组织厚度范围相关联。在某些情况下,如果所监测的力超过例如预定义阈值力,则处理器4314可断定切割刃不足够锐利以安全地横切所捕集组织。
图88所述的方法4600列出了例如在确定切割边缘182不足够锐利以安全地横切所捕集组织的情况下可由控制器4313采取的各种示例动作。在某些情况下,控制器4312可例如通过反馈系统1120向用户警示例如切割边缘182太钝而不能安全使用。在某些情况下,控制器4312可例如在断定切割边缘182不足够锐利以安全地横切所捕集组织时采用击发闭锁机构1122来阻止切割边缘182的推进。在某些情况下,控制器4312例如可采用反馈系统1120来向用户提供指令以用于重设击发闭锁机构1122。
图90、图91示出了采用公共控制模块的设备、系统、和方法的各个方面,该公共控制器与结合外科器械(诸如,马达驱动外科器械4400)的多个马达一起使用。外科器械4400在许多方面类似于本公开描述的其它外科器械,例如,上文更详细描述的图1的外科器械10。外科器械4400包括外壳12、柄部组件14、闭合触发器32、可互换轴组件200、以及端部执行器300。因此,为本公开的简洁和清楚起见,与外科器械10相同的外科器械4400的某些特征结构的详细描述将不在此处进行重复。
仍参见图90、图91,外科器械4400可包括多个马达,这些多个马达可被启动以结合外科器械4400的操作来执行各种功能。在某些情况下,可以启动第一马达以执行第一功能;可以启动第二马达以执行第二功能;并且可以启动第三马达以执行第三功能。在某些情况下,外科器械4400的多个马达可被单独地启动以导致端部执行器300(图1、图15)中的关节运动动作、闭合动作、和/或击发动作。关节运动动作、闭合动作、和/或击发动作可例如通过可互换轴组件200(图1)传输到端部执行器300。
在某些情况下,如图91所示,外科器械4400可包括击发马达4402。击发马达4402可操作地联接到击发驱动组件4404,该击发驱动组件可被配置成能够将由击发马达4402产生的击发动作传输到端部执行器300(图1、图14)。在某些情况下,由击发马达4402产生的击发动作可导致例如钉191从外科钉仓304部署到由端部执行器300捕集的组织内并且/或者导致切割边缘182被推进以切割所捕集组织。
在某些情况下,如图91所示,外科器械4400可包括例如关节运动马达4406。关节运动马达4406可操作地联接到关节运动驱动组件4408,该关节运动驱动组件可被配置成能够将由关节运动马达4406产生的关节运动动作传输到端部执行器300(图1、图14)。在某些情况下,关节运动动作可导致例如端部执行器300相对于可互换轴组件200(图1)进行关节运动。在某些情况下,外科器械4400可包括例如闭合马达。闭合马达可操作地联接到闭合驱动组件,该闭合驱动组件可被配置成能够将闭合动作传输到端部执行器300。在某些情况下,闭合动作可导致例如端部执行器300从打开构型转变成逼近构型以捕集组织。读者将会知道,本文所述的马达及其对应驱动组件旨在作为可结合本公开使用的马达和/或驱动组件的类型的示例。外科器械4400可包括可用于结合外科器械4400的操作来执行各种其它功能的各种其它马达。
如上所述,外科器械4400可包括多个马达,所述多个马达可被配置成能够执行各种独立功能。在某些情况下,外科器械4400的多个马达可被单独地或独立地激活以执行一个或多个功能,而其它马达保持非活动的。例如,关节运动马达4406可被启动以导致端部执行器300(图1、图14)进行关节运动,而击发马达4402保持未激活。另选地,击发马达4402可被启动以击发多个钉191(图14)和/或推进切割边缘182,而关节运动马达4406保持未激活。
参照图90、图91,在某些情况下,外科器械4400可包括公共控制器4410,该公共控制器可与外科器械4400的多个马达4402、4406一起使用。在某些情况下,公共控制器4410每次可调节多个马达中的一个。例如,公共控制器4410可分别单独地联接到外科器械4400的多个马达。在某些情况下,外科器械4400的多个马达可共用一个或多个公共控制器,诸如公共控制器4410。在某些情况下,外科器械4400的多个马达可独立地或选择性地接合公共控制器4410。在某些情况下,公共控制器4410可从接合外科器械4400的多个马达中的一个切换到接合外科器械4400的多个马达中的另一个。
在至少一个示例中,公共控制器4410可在可操作地接合关节运动马达4406与可操作地接合击发马达4402之间选择性地切换。在至少一个示例中,如图90所示,开关4414可在多个位置和/或状态(例如,第一位置4416和第二位置4418)之间运动或转变。在第一位置4416中,开关4414可以将公共控制器4410电联接到关节运动马达4406;并且在第二位置4418中,开关4414可以将公共控制器4410电联接到例如击发马达4402。在某些情况下,当开关4414处于第一位置4416时,公共控制器4410可电联接到关节运动马达4406,以控制关节运动马达4406的操作,由此使端部执行器300(图1、图15)关节运动到所需位置。在某些情况下,当开关4414处于第二位置4418时,公共控制器4410可例如电联接到击发马达4402,以控制击发马达4402的操作,由此击发多个钉191(图14)和/或推进切割边缘182(图14)。在某些情况下,开关4414可为机械开关、机电开关、固态开关、或任何合适的开关机构。
现在参见图91,为本公开的清楚起见,外科器械4400的柄部组件14的外部壳体被移除并且外科器械4400的若干特征结构和元件也被移除。在某些情况下,如图91所示,外科器械4400可包括可在多个位置和/或状态之间选择性地转变的接口4412。在第一位置和/或状态中,接口4412可以将公共控制器4410(图90)联接到第一马达,诸如,关节运动马达4406;并且在第二位置和/或状态中,接口4412可以将公共控制器4410联接到第二马达,诸如,击发马达4402。本公开可设想到接头4412的附加的位置和/或状态。
在某些情况下,接口4412能够在第一位置和第二位置之间运动,其中公共控制器4410(图90)在第一位置中联接到第一马达并且在第二位置中联接到第二马达。在某些情况下,当接口4412从第一位置运动时,公共控制器4410与第一马达分离;并且当接口4412从第二位置运动时,公共控制器4410与第二马达分离。在某些情况下,开关或触发器可被配置成能够使接头4412在多个位置和/或状态之间转变。在某些情况下,触发器能够运动以同时地致动端部执行器并且使公共控制器4410从可操作地接合外科器械4400的马达中的一个转变成可操作地接合外科器械4400的马达中的另一个。
在至少一个示例中,如图91所示,闭合触发器32可操作地联接到接口4412并且可被配置成能够使接口4412在多个位置和/或状态之间转变。如图91所示,闭合触发器32能够例如在击发行程期间运动,以例如使接口4412从第一位置和/或状态转变到第二位置和/或状态同时使端部执行器300转变到逼近构型以通过端部执行器捕集组织。
在某些情况下,在第一位置和/或状态中,公共控制器4410可电联接到第一马达,诸如,关节运动马达4406,并且在第二位置和/或状态中,公共控制器4410可电联接到第二马达,诸如,击发马达4402。在第一位置和/或状态中,公共控制器4410可以与关节运动马达4406接合,以允许使用者将端部执行器300(图1、图15)铰接到期望位置;并且公共控制器4410可以保持与关节运动马达4406接合,直到致动闭合触发器32。当用户致动闭合触发器32以通过所需位置下的端部执行器300捕集组织时,接口4412可进行转变或移位,以使公共控制器4410从例如可操作地接合关节运动马达4406转变成例如可操作地接合击发马达4402。一旦建立了与击发马达4402的可操作接合,则公共控制器4410就可以控制击发马达4402;例如,响应于用户输入,公共控制器4410可以启动击发马达4402以击发多个钉191(图14)和/或推进切割边缘182(图14)。
在某些情况下,如图91所示,公共控制器4410可包括适于与接口4412联接的多个电触点和/或机械触点4411。共用公共控制器4410的外科器械4400的多个马达可各自包括例如适于与接口4412联接的一个或多个对应的电触点和/或机械触点4413。
在各种情况下,外科器械4400的马达可为电动马达。在某些情况下,外科器械4400的马达中的一个或多个可为例如具有大约25,000RPM的最大转速的直流有刷驱动马达。在其它构造中,外科器械4400的马达可包括一个或多个下述马达,所述马达选自无刷马达、无绳马达、同步马达、步进马达、或任何其它合适的电动马达。
在各种情况下,如图90所示,公共控制器4410可包括马达驱动器4426,该马达驱动器可包括一个或多个H-桥场效应晶体管(FET)。马达驱动器4426可例如基于来自控制器4420(“微控制器”)的输入来调节从电源4428传输到联接至公共控制器4410的马达的电力。在某些情况下,当马达联接到公共控制器4410时,可例如采用控制器4420来确定由马达消耗的电流,如上所述。
在某些情况下,控制器4420可包括处理器4422(“微处理器”)和一个或多个计算机可读介质或存储器4424(“存储单元”)。在某些情况下,存储器4424可存储各种程序指令,这些各种程序指令在执行时可使得处理器4422执行本文描述的多个功能和/或计算。在某些情况下,存储器4424中的一个或多个可例如联接到处理器4422。
在某些情况下,电源4428可例如用于将电力提供给控制器4420。在某些情况下,电源4428可包括电池(或者“电池组”或“电源组”),例如,锂离子电池。在某些情况下,电池组可被构造成能够可释放地安装到柄部组件14以用于将功率供应给外科器械4400。可将多个串联的电池单元用作电源4428。在某些情况下,电源4428可为例如可更换的和/或可再充电的。
在各种情况下,处理器4422可控制马达驱动器4426以控制联接到公共控制器4410的马达的位置、旋转方向、和/或速度。在某些情况下,处理器4422可发信号通知马达驱动器4426,以停止和/或停用联接到公共控制器4410的马达。应当理解,本文使用的术语“处理器”包括任何合适的处理器、控制器,或者将计算机的中央处理单元(CPU)的功能结合到一个集成电路或最多几个集成电路上的其它基础计算装置。处理器是多用途的可编程装置,该装置接收数字数据作为输入,依据其存储器中存储的指令来处理输入,然后提供结果作为输出。因为处理器具有内部存储器,所以是顺序数字逻辑的示例。处理器的操作对象是以二进制数字系统表示的数字和符号。在一种情况下,处理器4422可以是如结合图15至图17B所述的单核或多核控制器LM4F230H5QR。
在某些情况下,存储器4424可包括用于控制可联接到公共控制器4410的外科器械4400的马达中的每个的程序指令。例如,存储器4424可包括用于控制关节运动马达4406的程序指令。当关节运动马达4406联接到公共控制器4410时,此类程序指令可导致处理器4422根据用户输入来控制关节运动马达4406以使端部执行器300进行关节运动。又如,存储器4424可包括用于控制击发马达4402的程序指令。当击发马达4402联接到公共控制器4410时,此类程序指令可导致处理器4422根据用户输入来控制击发马达4402以击发多个钉191并且/或者推进切割边缘182。
在某些情况下,一个或多个机构和/或传感器(例如,传感器4430)可用于提示处理器4422使用应当用于特定设置中的程序指令。例如,传感器4430可以警示处理器4422使用与端部执行器300(图1、图14)的关节运动相关联的程序指令,同时公共控制器4410联接到关节运动马达4406;并且传感器4430可以警示处理器4422使用与击发外科器械4400相关联的程序指令,同时公共控制器4410联接到击发马达4402。在某些情况下,传感器4430可包括例如可用于感测开关4414的位置的位置传感器。因此,处理器4422可以在例如通过传感器4430检测到开关4414处于第一位置4416时使用与端部执行器300的关节运动相关联的程序指令;并且处理器4422可以在例如通过传感器4430检测到开关4414处于第二位置4418时使用与击发外科器械4400相关联的程序指令。
现在参见图92,为本公开的清楚起见,外科器械4400的外部壳体被移除并且外科器械4400的若干特征结构和元件也被移除。如图92所示,外科器械4400可包括多个传感器,所述多个传感器可用于结合外科器械4400的操作来执行各种功能。例如,如图92所示,外科器械4400可包括传感器A、B和/或C。在某些情况下,传感器A可用于执行第一功能,例如;例如,传感器B可用于执行第二功能;例如,传感器C可用于执行第三功能。在某些情况下,传感器A可用于在闭合行程的第一区段期间感测由端部执行器300(图1、图14)捕集的组织厚度;传感器B可用于在第一区段之后的闭合行程的第二区段期间感测组织厚度;例如,传感器C可用于在第二区段之后的闭合行程的第三区段期间感测组织厚度。在某些情况下,传感器A、B、和C可例如沿端部执行器300进行设置。
在某些情况下,如图94所示,传感器A、B、和C可被布置成使得例如传感器A设置在传感器B的近侧并且传感器C设置在传感器B的近侧。在某些情况下,如图92所示,传感器A可以感测由端部执行器300在第一位置捕集的组织的组织厚度;传感器B可以在远离第一位置的第二位置处感测由端部执行器300捕集的组织的组织厚度;例如,传感器C可以在远离第二位置的第三位置处感测由端部执行器300捕集的组织的组织厚度。读者将会知道,本文所述的传感器旨在作为可结合本公开使用的传感器的类型的示例。本公开可采用其它合适的传感器和感测构造。
在某些情况下,外科器械4400可包括控制器4450,该控制器可在许多方面类似于公共控制器4410。例如,类似于公共控制器4410的控制器4450可包括控制器4420、处理器4422、和/或存储器4424。在某些情况下,电源4428可例如将电力提供给控制器4450。在某些情况下,外科器械4400可包括多个传感器,例如,传感器A、B、和C,所述多个传感器可被启动以结合外科器械4400的操作来执行各种功能。在某些情况下,传感器A、B、和C中的一个例如可被单独地或独立地启动以执行一个或多个功能,而其它传感器保持未激活。在某些情况下,外科器械4400的多个传感器(例如,传感器A、B、和C)可共用控制器4450。在某些情况下,每次传感器A、B、和C中的仅一个可联接到控制器4450。在某些情况下,外科器械4400的多个传感器例如可单独地或独立地联接到控制器4450。在至少一个示例中,控制器4450可在与传感器A、传感器B、和/或传感器C的可操作接合之间选择性地切换。
在某些情况下,如图92所示,控制器4450可例如设置在柄部组件14中,并且共用控制器4450的传感器可例如设置在端部执行器300(图1、图14)中。读者将会知道,控制器4450和/或共用控制器4450的传感器并不限于上文指明的位置。在某些情况下,控制器4450和共用控制器4450的传感器可例如设置在端部执行器300中。本公开可设想到用于控制器4450和共用控制器4450的传感器的位置的其它布置方式。
在某些情况下,如图92所示,接口4452可用于控制外科器械4400的传感器与控制器4450的联接和/或分离。在某些情况下,接头4452可在多个位置和/或状态之间选择性地转变。在第一位置和/或状态中,接口4452可以将控制器4450联接到传感器A,例如;在第二位置和/或状态中,接口4452可以将控制器4450联接到传感器B,例如;并且在第三位置和/或状态中,接口4452可以将控制器4450联接到传感器C,例如。本公开可设想接口4452的附加的位置和/或状态。
在某些情况下,接口4452能够例如在第一位置、第二位置、和/或第三位置之间运动,其中控制器4450在第一位置中联接到第一传感器,在第二位置中联接到第二传感器,并且在第三位置中联接到第三传感器。在某些情况下,当接口4452从第一位置运动时,控制器4450与第一传感器分离;当接口4452从第二位置运动时,控制器4450与第二传感器分离;当接口4452从第三位置运动时,控制器4450与第三传感器分离。在某些情况下,开关或触发器可被配置成能够使接口4452在多个位置和/或状态之间转变。在某些情况下,触发器能够运动以例如同时地致动端部执行器并且使控制器4450从可操作地接合共用控制器4450的传感器中的一个转变成可操作地接合共用控制器4450的传感器中的另一个。
在至少一个示例中,如图92所示,闭合触发器32可操作地联接到接口4452并且可被配置成能够使接口4452在多个位置和/或状态之间转变。如图92所示,闭合触发器32能够例如在击发行程期间在多个位置之间运动,以使接口4452在例如其中控制器4450电联接到传感器A的第一位置和/或状态、例如其中控制器4450电联接到传感器B的第二位置和/或状态、和/或例如其中控制器4450电联接到传感器C的第三位置和/或状态之间转变。
在某些情况下,用户可致动闭合触发器32以通过端部执行器300捕集组织。闭合触发器的致动可导致接口4452进行转变或移位,以使控制器4450从例如可操作地接合传感器A转变成例如可操作地接合传感器B、和/或从例如可操作地接合传感器B转变成例如可操作地接合传感器C。
在某些情况下,当闭合触发器32处于第一致动位置时,控制器4450可联接到传感器A。当闭合触发器32穿过第一致动位置朝第二致动位置致动时,控制器4450可与传感器A分离。另选地,当闭合触发器32处于未致动位置时,控制器4450可联接到传感器A。当闭合触发器32穿过未致动位置朝第二致动位置致动时,控制器4450可与传感器A分离。在某些情况下,当闭合触发器32处于第二致动位置时,控制器4450可联接到传感器B。当闭合触发器32穿过第二致动位置朝第三致动位置致动时,控制器4450可与传感器B分离。在某些情况下,当闭合触发器32处于第三致动位置时,控制器4450可联接到传感器C。
在某些情况下,如图92所示,控制器4450可包括适于与接口4452联接的多个电触点和/或机械触点4451。共用控制器4450的外科器械4400的多个传感器可各自包括例如适于与接口4452联接的一个或多个对应的电触点和/或机械触点4453。
在某些情况下,当传感器联接到接口4452时,处理器4422可接收来自共用控制器4450的多个传感器的输入。例如,当传感器A联接到控制器4450时,处理器4422可以从传感器A接收输入;当传感器B联接到控制器4450时,处理器4422可以从传感器B接收输入;并且当传感器C联接到控制器4450时,处理器4422可以从传感器C接收输入。在某些情况下,输入可为测量值,例如,由端部执行器300(图1、图15)捕集的组织的组织厚度的测量值。在某些情况下,处理器4422可将来自传感器A、B、和C中的一个或多个的输入存储在存储器4424上。在某些情况下,处理器4422可基于例如由传感器A、B、和C提供的输入来执行各种计算。
图93A和图93B示出了包括钉仓5306的端部执行器5300的一个方面,该钉仓还包括两个发光二极管5310(LED)。图93A示出了端部执行器5300,其包括位于仓平台5308的任一侧上的一个LED 5310。图91B示出了其中砧座5302处于打开位置的端部执行器5300的四分之三角视图,以及位于仓平台5308的任一侧面上的一个LED 5310。端部执行器5300类似于上述端部执行器300(图1、图15)。端部执行器包括能够枢转地联接到钳口构件或细长通道5304的砧座5302。细长通道5304被构造成能够在其中接收钉仓5306。钉仓5306包括多个钉(未示出)。多个钉能够在外科操作期间从钉仓5306部署。钉仓5306还包括安装在钉仓5306的上表面或仓平台5308上的两个LED 5310。LED 5310被安装成使得它们将在砧座5302处于闭合位置时可见。此外,LED 5310可足够明亮以穿过任何组织可见,该组织可遮蔽LED 5310的直视。除此之外,一个LED 5310可安装在钉仓5306的任一侧面上,使得至少一个LED 5310从端部执行器5300的任一侧可见。LED 5310可安装在钉仓530的近侧端部附近,如图所示,或者可安装在钉仓5306的远侧端部处。
LED 5310可与处理器或控制器通信,诸如,控制器1500(图19)。控制器1500可被配置成能够检测由砧座5302抵靠仓平台5308压缩的组织的特性。由端部执行器5300包封的组织可因组织内的流体从组织的各层渗出而改变高度。在组织已足够稳定之前缝合组织可影响缝合的有效性。组织稳定性通过以变化率表示,其中变化率指示由端部执行器包封的组织正如何快速地改变高度。
位于器械操作者的视野中的安装到钉仓5306的LED 5310可用于指示所包封组织正变稳定的速率和/或组织是否已达到稳态。LED 5310可例如被配置成能够以与组织稳定速率直接相关联的速率闪烁,即,初始可快速地闪烁、随着组织的稳定而较慢地闪烁、并且在组织稳定时保持稳态。另选地,LED 5310可初始缓慢地闪烁、随着组织的温度而较快速地闪烁、并且在组织稳定时熄灭。
安装在钉仓5306上的LED 5310可附加地或任选地用于指示其它信息。其它信息的示例包括但不限于:端部执行器5300是否正包封足够量的组织、钉仓5306是否适用于所包封的组织、所包封的组织是多于适用于钉仓5306的组织、钉仓5306是否与外科器械不相容、将对器械的操作者有用的任何其它指示信息。LED 5310可通过以特定速率闪烁、在特定情况下点亮或熄灭、针对不同信息以不同颜色发光来指示信息。另选地或除此之外,LED 5310可用于照亮操作区域。在一些方面,可选择LED 5310以发射紫外光或红外光来照亮在正常光下不可见的信息,其中该信息被打印在位于端部执行器5300处的钉仓上或组织补偿件(未示出)上。另选地或除此之外,钉可涂覆有发荧光染料并且LED 5310的波长可被选定以使得LED 5310导致发荧光染料发光。利用LED 5310照亮钉允许器械的操作者观察已被驱动之后的钉。
图94A和图94B示出了包括钉仓5356的端部执行器5300的一个方面,该钉仓还包括多个LED 5360。图92A示出了其中砧座5302处于闭合位置的端部执行器5300的侧面角视图。以举例的方式,例示的方面包括位于仓平台5358的任一侧面上的多个LED 5360。图92B示出了其中砧座5302处于打开位置的端部执行器5300的四分之三角视图,其示出了位于仓平台5358的任一侧面上的多个LED 5360。钉仓5356包括安装到钉仓5356的仓平台5358上的多个LED 5360。LED 5360被安装成使得它们将在砧座5302处于闭合位置时可见。此外,LED 5360可足够明亮以穿过任何组织可见,该组织可遮蔽LED 5360的直视。除此之外,相同数目的LED 5360可安装在钉仓5356的任一侧面上,使得相同数目的LED 5360从端部执行器5300的任一侧面可见。LED 5360可安装在钉仓5356的近侧端部附近,如图所示,或者可安装在钉仓5356的远侧端部处。
LED 5360可与处理器或控制器通信,诸如,图15的控制器1500。控制器1500可被配置成能够检测由砧座5302抵靠仓平台5358压缩的组织的特性,诸如,组织的稳定的速率,如上所述。LED 5360可用于指示所包封组织正变稳定的速率和/或组织是否已达到稳态。LED5360可被配置成能够例如根据开始于钉仓5356的近侧端部处的顺序点亮,其中每个后续LED 5360以所包封组织正变稳定的速率点亮;当组织稳定时,全部LED 5360可被点亮。另选地,LED 5360可根据开始于钉仓5356的远侧端部处的顺序点亮。然而,LED 5360的另一种另选形式根据连续的、重复的顺序点亮,其中,所述顺序开始于LED 5360的近侧端部或远侧端部处。LED 5360点亮的速率和/或重复速度可指示所包封组织正变稳定的速率。应当理解,这些仅为LED 5360可如何指示有关组织的信息的示例,并且也可使用LED 5360点亮的顺序的其它组合、它们点亮的速率、和/或它们的点亮或熄灭状态。还应当理解,LED 5360可用于将一些其它信息传送给外科器械的操作者或者照亮工作区域,如上所述。
图95A和图95B示出了包括钉仓5406的端部执行器5300的一个方面,该钉仓还包括多个LED 5410。图93A示出了其中砧座5302处于闭合位置的端部执行器5300的侧面角视图。以举例的方式,例示的方面包括从钉仓5406的近侧端部到远侧端部的位于仓平台5408的任一侧面上的多个LED 5410。图93B示出了其中砧座5302处于打开位置的端部执行器5300的四分之三角视图,其示出了从钉仓5406的近侧端部到远侧端部的并且位于仓平台5408的任一侧面上的多个LED 5410。钉仓5406包括安装在钉仓5406的仓平台5408上的多个LED5410,其中LED 5410从钉仓5406的近侧端部连续地布置到远侧端部。LED 5410被安装成使得它们将在砧座5302处于闭合位置时可见。相同数目的LED 5410可安装在钉仓5406的任一侧面上,使得相同数目的LED 5410从端部执行器5300的任一侧面可见。
LED 5410可与处理器或控制器通信,诸如,图15的控制器1500。控制器1500可被配置成能够检测由砧座5302抵靠仓平台5408压缩的组织的特性,诸如,组织的稳定的速率,如上所述。LED 5410可被配置成能够根据所需的顺序或分组点亮或熄灭,以指示组织的稳定的速率和/或组织已稳定。LED 5410还可被配置成能够将一些其它信息传送给外科器械的操作者或者照亮工作区域,如上所述。除此之外或另选地,LED 5410可被配置成能够指示端部执行器5300的哪些区域包括稳定组织、和/或端部执行器5300的哪些区域正包封组织、和/或这些区域是否正包封足够的组织。LED 5410还可被配置成能够指示所包封组织的任何部分是否不适用于钉仓5406。
现在主要参见图96和图97,功率组件2096可包括功率调制器控制装置2106,该功率调制器控制装置可包括例如一个或多个场效应晶体管(FET)、达林顿阵列、可调式放大器和/或任何其它功率调制器。当可互换工作组件2094联接到功率组件2096时,响应于由工作组件控制器2102产生的信号,功率组件控制器2100可致动功率调制器控制装置2106,从而根据可互换工作组件2094的功率需求来设定电池2098的功率输出。
仍主要参见图96和图97,当可互换工作组件2094联接到功率组件2096时,功率组件控制器2100可被配置成能够监测从功率组件2096到可互换工作组件2094的功率传输,以便检测由可互换工作组件2094的工作组件控制器2102产生的一个或多个信号。如图96所示,例如,功率组件控制器2100可利用用于监测电池2098两端的电压的电压监测机构,来检测由工作组件控制器2102产生的一个或多个信号。在某些情况下,电压调节器可用于按比例调节电池2098的电压,以使得该电压可由功率组件控制器2100的模/数转换器(ADC)读出。如图96所示,例如,电压调节器可包括分压器2108,该分压器可生成基准电压或与电池2098的电压成比例的低电压信号,该信号可通过ADC测量并记录到功率组件控制器2100。
在其它情况下,如图97所示,例如,功率组件2096可包括电流监测机构,用于监测传输到可互换工作组件2094的电流,从而检测由工作组件控制器2102产生的一个或多个信号。在某些情况下,功率组件2096可包括电流传感器2110,该电流传感器可用于监测传输到可互换工作组件2094的电流。所监测的电流可通过例如ADC记录到功率组件控制器2100。在其它情况下,功率组件控制器2100可被配置成能够同时监测传输至可互换工作组件2094的电流和电池2098两端间的对应电压两者,以检测由工作组件控制器2102生成的一个或多个信号。读者应当理解,用于监测电流和/或电压的各种其它机构可由功率组件控制器2100使用,以检测由工作组件控制器2102生成的一个或多个信号。本公开设想出所有这些机构。
参见图98,控制器13002通常可包括处理器13008(“微处理器”)和可操作地联接到处理器13008的一个或多个存储器单元13010。例如,处理器13008通过执行存储器13010中存储的指令码,可控制外科器械12200的各种部件,诸如马达12216、各种驱动系统和/或用户显示器。控制器13002可使用集成的和/或分立的硬件元件、软件元件和/或该硬件元件和软件元件两者的组合来实现。集成硬件元件的示例可包括处理器、微处理器、控制器、集成电路、专用集成电路(ASIC)、可编程逻辑器件(PLD)、数字信号处理器(DSP)、现场可编程门阵列(FPGA)、逻辑门、寄存器、半导体器件、芯片、微芯片、芯片组、控制器、片上系统(SoC)和/或封装系统(SIP)。分立硬件元件的示例可包括电路和/或电路元件,诸如逻辑门、场效应晶体管、双极型晶体管、电阻器、电容器、电感器和/或继电器。在某些情况下,例如,控制器13002可包括混合电路,该混合电路在一个或多个基板上包括分立的和集成的电路元件或部件。在某些情况下,控制器13002可以是如结合图15至图17B所述的单核或多核控制器LM4F230H5QR。
在各种形式中,马达12216例如可以是具有约25,000RPM的最大旋转的直流有刷驱动马达。在其它构造中,马达12216可包括无刷马达、无绳马达、同步马达、步进马达或任何其它合适的电动马达。例如,电池12218(或称“功率源”或“功率组”),诸如锂离子电池,可联接到外壳12212,以向马达12216提供电力。
再次参见图98,外科器械12200可包括与控制器13002可操作地通信的马达控制器13005。马达控制器13005可被配置成能够控制马达12216的旋转方向。在某些情况下,马达控制器13005可被配置成能够根据来自控制器13002的输入确定由电池12218向马达12216施加的电压极性,继而确定马达12216的旋转方向。例如,当电池12218施加到马达12216的电压极性被马达控制器13005根据来自控制器13002的输入反转时,马达12216可将其旋转方向从顺时针方向反转成逆时针方向。另外,例如,马达12216能够可操作地联接到关节运动驱动器,该驱动器可取决于马达12216旋转的方向而被马达12216朝远侧或朝近侧驱动。此外,关节运动驱动器能够可操作地联接到端部执行器12208,使得例如关节运动驱动器朝近侧进行轴向平移可导致端部执行器12208沿例如逆时针方向进行关节运动,并且/或者关节运动驱动器朝远侧进行轴向平移可导致端部执行器12208沿例如顺时针方向进行关节运动。
在图99所示的方面中,接口3001包括多个开关3004A-C、3084B,其中每个开关3004A-C分别经由三个电路3006A-C中的一个联接到控制器3002,并且开关3084B经由电路3084A联接到控制器3002。读者将理解,通过接口3001可以利用开关和电路的其它组合。
除上述之外,控制器3002可包括处理器3008和/或一个或多个存储器单元3010。通过执行存储器3010中存储的指令码,处理器3008可控制外科器械的各种部件,诸如电动马达1102和/或用户显示器。控制器3002可使用集成和/或离散硬件元件、软件元件、和/或它们的组合来实现。集成硬件元件的示例可包括处理器、微处理器、控制器、集成电路、专用集成电路(ASIC)、可编程逻辑器件(PLD)、数字信号处理器(DSP)、现场可编程门阵列(FPGA)、逻辑门、寄存器、半导体器件、芯片、微芯片、芯片组、控制器、片上系统(SoC)和/或封装系统(SIP)。离散硬件元件的示例可包括电路和/或电路元件(例如逻辑门、场效应晶体管、双极型晶体管、电阻器、电容器、电感器、继电器等)。在其它方面,控制器3002可包括混合电路,例如在一个或多个基底上包括离散和集成电路元件或部件。
再次参见图99,外科器械1010可包括与控制器3002可操作地通信的马达控制器3005。马达控制器3005被配置成能够控制电动马达1102的旋转方向。例如,电动马达1102可由电池,例如电池1104,并且控制器3002可被配置成能够根据来自控制器3002的输入确定电池1104向电动马达1102施加的电压极性,继而确定电动马达1102的旋转方向。例如,当电池1104施加到电动马达1102的电压极性被马达控制器3005根据来自控制器3002的输入反向时,电动马达1102可将其旋转方向从顺时针方向反向成逆时针方向。合适的马达控制器的示例在本文的其它地方有所描述,包括但不限于驱动器7010(图100)。
另外,如本文其它地方更详细描述的,电动马达1102可以被可操作地联接到关节运动驱动器。在使用中,电动马达1102可以根椐电动马达1102旋转的方向将近侧关节运动驱动器朝远侧或朝近侧驱动。此外,近侧关节运动驱动器可以被操作地联接到端部执行器1300,使得例如近侧关节运动驱动器10030朝近侧的轴向平移可导致端部执行器1300在例如逆时针方向进行关节运动,和/或近侧关节运动驱动器10030朝远侧的轴向平移可导致端部执行器1300在例如顺时针方向进行关节运动。
除上述之外,再次参见图99,接口3001可以能够使得开关3004A可专用于端部执行器1300的顺时针关节运动,并且开关3004B可专用于端部执行器1300的逆时针关节运动。例如,操作者可通过以下方式使端部执行器1300沿顺时针方向进行关节运动:闭合可向控制器3002发送信号的开关3004A来使电动马达1102沿顺时针方向旋转,从而因此导致近侧关节运动驱动装置10030朝远侧推进并导致端部执行器1300沿顺时针方向进行关节运动。又如,操作者可通过以下方式使端部执行器1300沿逆时针方向进行关节运动:闭合可向控制器3002发送信号的开关3004B以使电动马达1102沿例如逆时针方向旋转,并使近侧关节运动驱动装置10030朝近侧回缩,以使端部执行器1300沿逆时针方向进行关节运动。
如图100所示,传感器构造7002提供对应于纵向可动驱动构件1111的位置的独特位置信号。电动马达1102可包括可操作地与齿轮组件7014交接的可旋转轴7016,该齿轮组件与一组或一齿条的驱动齿啮合安装在纵向可移动驱动构件1111上。还参照图101,传感器元件7026能够可操作地联接到齿轮组件7106,使得传感器元件7026的单次旋转对应于纵向可动驱动构件1111的某个线性纵向平移,如下文更详细所述。在一个方面,齿轮传动装置和传感器的结构可经由齿条和小齿轮布置连接至线性致动器,或者经由直齿齿轮或其它连接连接至旋转致动器。对于包括旋转螺杆驱动构型的方面而言,其中将需要更大数目的转动,可在驱动构件和传感器之间采用高减速齿轮传动装置布置,如蜗杆与蜗轮。
根据本公开的一个方面,绝对定位系统7000的传感器构造7002提供更稳固的位置传感器7012以与外科装置一起使用。通过为每个可能的致动器位置提供独特位置信号或值,此类结构无需进行归零或校正步骤并且减少以下情况下消极设计影响的可能性,其中噪音或电源掉电状况可如常规旋转编码器构型中一样产生位置感测错误。
在一个方面,绝对定位系统7000的传感器布置7002替换通常附接到马达转子的常规旋转编码器并且将其替换为位置传感器7012,该位置传感器在与位置传感器7012相关联的传感器元件的单次旋转中针对每个可旋转位置生成独特位置信号。从而,与位置传感器7012相关联的传感器元件的单一旋转等同于能够纵向运动的驱动构件1111的纵向线性位移d1。换句话讲,d1为联接到纵向可移动驱动构件1111的传感器元件的单一旋转之后纵向可移动驱动构件1111从点“a”向点“b”移动的纵向线性距离。可经由齿轮减速连接传感器布置7002,这使得位置传感器7012针对能够纵向运动的驱动构件1111的全行程仅完成单次转动。利用合适的齿轮齿数比,能够纵向运动的驱动构件1111的全行程可用位置传感器7012的一次转动表示。
可单独或结合齿轮减速采用一系列开关7022a至7022n(其中n为大于一的整数)以针对位置传感器7012的不止一次旋转提供独特位置信号。开关7022a-7022n的状态被馈送回控制器7004,该微控制器应用逻辑以确定对应于纵向可移动驱动构件1111的纵向线性位移d1+d2+…dn的独特位置信号。
因此,绝对定位系统7000在器械加电时提供能够纵向运动的驱动构件1111的绝对位置,并且不使能够纵向运动的驱动构件1111回缩或推进至如常规旋转编码器可需要的复位(清零或本位)位置,这些编码器仅对马达采取的向前或向后的步骤数进行计数以推断装置致动器、驱动棒、刀等等的位置。
在各个方面,传感器布置7002的位置传感器7012可包括例如一个或多个磁性传感器、模拟旋转传感器(如电位差计)、模拟霍尔效应元件阵列等,该霍尔效应元件输出位置信号或值的独特组合。
在各个方面,可对控制器7004进行编程以执行各种功能,诸如对刀和关节运动系统的速度和位置的精确控制。使用已知的物理特性,控制器7004可被设计成模拟实际系统在控制器7004的软件中的响应。将所模拟响应与实际系统的(嘈杂离散)所测量响应进行比较,以获得“观察到的”响应,其用于实际反馈决定。观察到的响应为有利的调谐值,该值使所模拟响应的平滑连续性质与所测量响应均衡,其可感测对系统的外部影响。
在各个方面,绝对定位系统7000还可包括和/或被编程为执行下列功能。反馈控制器,其可为任何反馈控制器中的一者,包括但不限于:PID、状态反馈和自适应。电源将来自反馈控制器的信号转换为对系统的物理输入,在这种情况下为电压。其它示例包括但不限于脉宽调制(PWMed)电压、电流和力。电动马达1102可为有刷直流马达,其具有齿轮箱以及至关节运动或刀系统的机械链接。除了位置传感器7012所测量的位置之外,可提供其它传感器7018以测量物理系统的物理参数。由于其为数字信号(或连接至数字数据采集系统),其输出将具有有限的分辨率和取样频率。可提供比较和组合电路以使用算法(诸如,在无限制的情况下,加权平均数和理论控制回路)将所模拟响应与所测量响应组合,其使得朝所测量响应驱动所模拟响应。物理系统的模拟将比如质量、惯性、粘性摩擦、电感电阻等性能考虑在内,以通过得知输入预测物理系统的状态和输出。在一个方面,控制器7004可以是如结合图15至图17B所述的单核或多核控制器LM4F230H5QR。
在一个方面,驱动器7010可为购自Allegro Microsystems,Inc的A3941。A3941驱动器7010为全桥控制器,其用于与针对电感负载特别设计的外部N通道功率金属氧化物半导体场效应晶体管(MOSFET)一起使用,例如有刷直流马达。驱动器7010包括独特的电荷泵调节器,其为低至7V的电池电压提供完整的(>10V)栅极驱动并且允许A3941在低至5.5V的减速栅极驱动下工作。可采用自举电容器提供N通道MOSFET所需的上述电池供电电压。高边驱动装置的内部电荷泵允许直流(100%占空比)操作。可使用二极管或同步整流在快衰减模式或慢衰减模式下驱动全桥。在慢衰减模式下,电流再循环可穿过高边或低边FET。通过电阻器可调式空载时间保护功率FET不被击穿。整体诊断指示欠压、过热和功率桥故障,并且可被配置成能够在大多数短路情况下保护功率MOSFET。其它马达驱动器可容易地取代以用于绝对定位系统7000中。因此,本公开不应限于这一上下文。
描述总体架构以用于针对传感器构造7002执行绝对定位系统7000的各种方面之后,本公开现在转向图101至图103以获取绝对定位系统7000的传感器构造的一个方面的描述。在图101中示出的方面中,传感器构造7002包括位置传感器7100、磁体7102传感器元件、能够纵向运动的驱动构件1111(图100)的每次全行程转动一次的磁体保持器7104、和提供齿轮减速的齿轮组件7106。提供了结构元件(诸如托架7116)以支撑齿轮组件7106、磁体保持器7104和磁体7102。位置传感器7100包括一个或多个磁性感测元件(诸如,霍尔元件)并且被设置成邻近磁体7102。因此,当磁体7102旋转时,位置传感器7100的磁性感测元件确定经过一次转动的磁体7102的绝对角位置。
在各个方面,可在绝对定位系统7000上采用任何数目的磁性感测元件,诸如根据其测量整个磁场还是磁场的矢量分量归类的磁性传感器。用于产生上述两种类型磁性传感器的技术涵盖物理学和电子学的多个方面。用于磁场感测的技术包括探测线圈、磁通门、光泵、核旋、超导量子干涉仪(SQUID)、霍尔效应、各向异性磁电阻、巨磁电阻、磁性隧道结、巨磁阻抗、磁致伸缩/压电复合材料、磁敏二极管、磁敏晶体管、光纤、磁光,以及基于微机电系统的磁性传感器等。
在示出的方面中,齿轮组件7106包括第一齿轮7108和第二齿轮7110,其啮合接合以提供3:1齿轮齿数比连接。第三齿轮7112围绕轴7114旋转。第三齿轮与能够纵向运动的驱动构件1111啮合接合,并且当能够纵向运动的驱动构件1111沿远侧方向D前进时沿第一方向旋转,并且当能够纵向运动的驱动构件1111沿近侧方向P缩回时沿第二方向旋转。第二齿轮7110也围绕轴7114旋转,因此,第二齿轮7110围绕轴7114的旋转对应于能够纵向运动的驱动构件1111的纵向平移。从而,能够纵向运动的驱动构件1111沿远侧方向D或近侧方向P的一个全行程对应于第二齿轮7110的三次旋转和第一齿轮7108的单次旋转。由于磁体保持器7104联接到第一齿轮7108,磁体保持器7104随着能够纵向运动的驱动构件1111的每个全行程进行一次完整旋转。
图102为根据一个方面的绝对定位系统7000的传感器结构7002的分解透视图,其示出了电路1106和传感器结构7002的元件的相对对齐方式。位置传感器7100(本视图中未示出)由位置传感器保持器7118支撑,该位置传感器保持器限定孔7120,该孔适于包含位置传感器7100,该位置传感器与在下方旋转的磁体7102精确对齐。夹具联接到托架7116以及电路1106,并且在磁体7102随磁体保持器7104旋转时保持静止。提供了一种轮毂7122以与第一齿轮7108和磁体保持器7104配合。
图103为根据一个方面的绝对定位系统7000的位置传感器7100的一个方面的示意图,这些绝对定位系统包括磁性旋转绝对定位系统。在一个方面,位置传感器7100可作为AS5055EQFT单片磁性旋转位置传感器实现,其购自Austria Microsystems,AG。位置传感器7100与控制器7004交接,以提供绝对定位系统7000。位置传感器7100为低电压和低功率部件,并且包括位于磁体7102(图99、图100)上的位置传感器7100的区域7130中的四个霍尔效应元件7128A、7128B、7128C、7128D。在芯片上也提供了高分辨率ADC 7132和智能型电源管理控制器7138。提供了CORDIC处理器7136(针对坐标旋转数字计算机(COordinateRotation DIgital Computer)),也称为逐位法和Volder算法,以执行简单有效的算法来计算双曲线函数和三角函数,其仅需要加法、减法、位位移和表格查找操作。角位置、报警位和磁场信息通过诸如SPI接口7134的标准串行通信接口传输到控制器7004。位置传感器7100提供12或14位分辨率。位置传感器7100可以是以小QFN 16引脚4×4×0.85mm封装提供的AS5055芯片。
霍尔效应元件7128A、7128B、7128C、7128D位于旋转磁体正上方。霍尔效应为熟知效应,为了本公开简洁和清楚起见,在本文中将不进行详述。一般来讲,霍尔效应为电导体范围内的电压差值(霍尔电压)的产生,所述电导体横向于导体中的电流和垂直于电流的磁场。霍尔效应由埃德温霍尔(Edwin Hall)发现于1879年。霍尔系数被限定为感应电场与电流密度和所施加磁场的乘积的比率。其为从中制备导体的材料的特性,因为其值取决于构成电流的电荷载体的类型、数目和性能。在AS5055位置传感器7100中,霍尔效应元件7128A、7128B、7128C、7128D能够产生电压信号,其指示根据磁体7102经过单次旋转之后的角度的磁体7102(图186、图187)的绝对位置。由CORDIC处理器7136计算角度的这个值(其为独特位置信号),并且将其以机载方式存储在寄存器或存储器中的AS5055位置传感器7100上。在多种技术中,如在加电时或在控制器7004发出请求时,向控制器7004提供角度的值,其指示经过一次转动的磁体7102的位置。
AS5055位置传感器7100在连接至控制器7004时仅需要几个外部部件就可操作。使用单一电源的简单应用需要六根电线:两根电线用于电力,四根电线7140用于与控制器7004的SPI接口7134。可加入第七连接,以便向控制器7004发送中断以通知可读取新的有效角度。
在通电时,AS5055位置传感器7100执行完全通电序列,包括一个角度测量。该循环的完成表示为INT输出7142,并且角度值存储在内部寄存器中。一旦设定了这一输出,AS5055位置传感器7100就暂停为休眠模式。控制器7004可通过SPI接口7134从AS5055位置传感器7100读取角度值来响应INT输出7142处的INT请求。一旦控制器7004读取了角度值,就再次清除INT输出7142。由控制器7004通过SPI接口7134向位置传感器7100发送“读取角度”指令也自动使芯片加电并且启动另一个角度测量。控制器7004一完成角度值的读取,就清除INT输出7142并且将新的结果存储在角度寄存器中。通过设定INT输出7142和状态寄存器中的对应标志再次指示角度测量的完成。
由于AS5055位置传感器7100的测量原理,每个加电序列之后,在非常短的时间(~600μs)内仅执行单次角度测量。一个角度的测量一完成,AS5055位置传感器7100就暂停为掉电状态。未执行根据数字平均化的角度值的片上过滤,因为这将需要不止一个角度测量并且因此需要更长加电时间,这在低功率应用中是不期望的。可通过在控制器7004中对数个角度样品进行平均来减少角度抖动。例如,平均4个采样可使抖动减少6dB(50%)。
如上所述,可利用定位在外科器械系统1000的柄部1042内的电动马达1102使例如轴组件1200(包括击发构件1272和1280)的击发系统相对于轴组件1200的端部执行器1300推进和/或回缩,以便缝合和/或切割捕集在端部执行器1300内的组织。在各种情况下,可能期望使击发构件1272和1280以所需速度或在所需速度范围内推进。同样,可能期望使击发构件1272和1280以所需速度或在所需速度范围内回缩。在各种情况下,例如柄部1042的控制器7004和/或任何其它合适的控制器可被配置成能够控制击发构件1272和1280的速度。在一些情况下,控制器可被配置成能够基于例如向电动马达1102提供的电力的各种参数(诸如电压和/或电流)和/或电动马达1102的其它操作参数来预测击发构件1272和1280的速度。控制器也可被配置成能够基于向电动马达1102提供的电流和/或电压的先前值和/或系统的先前状态(如速度、加速度和/或位置)来预测击发构件1272和1280的当前速度。此外,控制器也可被配置成能够利用例如上述的绝对定位传感器系统来感测击发构件1272和1280的速度。在各种情况下,控制器可被配置成能够对击发构件1272和1280的预测速度与击发构件1272和1280的感测速度进行比较,以确定是否应当增加电动马达1102的功率以便增加击发构件1272和1280的速度和/或减小功率以便减小击发构件1272和1280的速度。名称为“MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT”的美国专利号8,210,411,该专利申请的公开内容全文以引用方式并入本文。名称为“SURGICAL INSTRUMENT HAVINGRECORDING CAPABILITIES”的美国专利号7,845,537,该专利申请的公开内容全文以引用方式并入本文。
使用本文所公开的器械的物理特性,现在转向图104和图105,例如控制器(诸如微控制器7004)可被设计成模拟器械的实际系统在控制器的软件中的响应。将所模拟响应与实际系统的(嘈杂离散)所测量响应进行比较,以获得“观察到的”响应,其用于实际反馈决定。观察到的响应为有利的调谐值,该值使所模拟响应的平滑连续性质与所测量响应均衡,其可感测对系统的外部影响。参见图104和图105,可根据或接近目标速率(或速度)移动轴组件1200的端部执行器1300中的击发元件,或切割元件。可利用图102和图103中所公开的系统以目标速率移动切割元件。系统可包括反馈控制器4200,其可为任何反馈控制器中的一者,包括但不限于例如PID、状态反馈、LQR和/或自适应控制器。系统还可包括电源。电源可将来自反馈控制器4200的信号转换为例如系统的物理输入,在这种情况下为电压。其它示例包括但不限于例如脉宽调制(PWM)电压、频率调制电压、电流、扭矩和/或力。
继续参见图104和图105,其中提到的物理系统为器械的被配置成能够驱动击发构件或切割构件的实际驱动系统。一个实例为有刷直流马达,其具有齿轮箱以及至关节运动和/或刀系统的机械链接。另一个示例为本文所公开的电动马达1102,其操作例如可互换轴组件的击发构件10060和关节运动驱动器10030。图104和图105中提到的外部影响4201(例如)为事物(比如组织、周围物体和摩擦)对物理系统的未测量的、不可预测的影响。此类外部影响可称为阻力并且可例如由马达4202表示,该马达与电动马达1102行为相反。在各种情况下,外部影响(诸如阻力)为物理系统的模拟偏离实际物理系统的主要原因。图104和图105中示出的以及下文进一步描绘的系统可解决击发构件或切割构件的预测行为与击发构件或切割构件的实际行为之间的差异。
继续参见图104和图105,其中提到的离散传感器对实际物理系统的物理参数进行测量。此类离散传感器的一个方面可包括本文描述的绝对定位传感器7102和系统。由于此类离散传感器的输出可为数字信号(或连接至数字数据采集系统),其输出可具有有限的分辨率和取样频率。可向例如控制器提供离散传感器的输出,诸如控制器7004。在各种情况下,控制器可将所模拟或所估计响应与所测量响应组合。在某些情况下,可能有用的是使用足够所测量响应以确保将外部影响考虑在内,而不使观察到的响应无用地嘈杂。执行该操作的算法的实例包括加权平均数和/或理论控制回路,其例如朝所测量响应驱动所模拟响应。最终,除上述之外,物理系统的模拟将例如质量、惰性、粘性摩擦和/或电感电阻之类的特性考虑在内,以通过得知输入预测物理系统的状态和输出。图103示出了另外的对操作实际系统所提供的电流进行评估和测量,其为又一个参数,可对该参数进行评估以用于控制例如轴组件1200的切割构件或击发构件的速度。在某些情况下,除了测量电压之外或代替测量电压,通过测量电流,可使物理系统更精确。尽管如此,本文所公开的想法可延伸为其它物理系统的其它状态参数的测量。
图106示出了根据本文描述的各个方面的外科器械6900的透视图。根据各个方面,外科器械6900包括传感器设备6950,以帮助识别手术部位处的各种组织和其它材料。外科器械6900类似于上文描述的那些,其中外科器械6900包括被构造成能够支撑钉仓的细长通道、可枢转地连接到细长通道的砧座、机械地联接到砧座的闭合构件、机械地联接到钉仓的刀、机械地联接到闭合构件和/或刀的电动马达、电联接到马达的马达控制器、以及电联接到马达控制器的控制电路。外科器械5500也类似于上文描述的那些,其中外科器械6900也包括传感器,这些传感器共同被配置成能够感测或测量闭合力、击发力、由马达消耗的电流、定位于细长通道与砧座之间的组织的阻抗、相对于细长通道的砧座的位置、刀的位置或其任何组合。外科器械6900也类似于上文描述的那些,其中外科器械6900也包括算法诸如闭合算法、击发算法、马达控制算法或其任何组合,其操作以动态地调节外科器械6900的操作。然而,外科器械6900与上文描述的不同之处在于外科器械6900还包括一个或多个附加算法(除了上文描述的那些之外),其为外科器械6900提供附加的控制功能,如下文所述。
通常,外科器械6900可以利用一个或多个闭合算法来控制闭合运动,该闭合运动将钳口夹持到定位于其间的组织,并且/或者利用一个或多个击发算法来控制击发运动,该击发运动击发和切断夹持在钳口之间的组织。在操作中,给定传感器感测或测量给定参数(例如,闭合力、击发力和/或其任何组合)并输出指示所感测/测量参数的信号。输出信号可以是模拟信号或数字信号。对于传感器输出的信号是模拟信号的情况,模拟信号输入到模拟变数字(A/D)的转换器,该转换器输出表示模拟信号的数字信号。然后将数字信号输入到驻留在外科器械5500中的控制器。对于传感器输出的信号是数字信号的情况,不需要A/D转换,并且传感器输出的数字信号可以输入到控制器。在发生触发、阈值和/或事件时,控制器可以修改或调节闭合算法,或发起不同的闭合算法,从而在闭合运动期间自动改变外科器械6900的操作。相似地,在发生触发、阈值和/或事件时,控制器可以修改或调节击发算法,或发起不同的击发算法,从而在击发运动期间自动改变外科器械5500的操作。
根据各个方面,触发、阈值或事件由感测/测量的闭合力限定。根据其它方面,触发、阈值或事件由与感测/测量的闭合力相关的参数限定。相似地,根据各个方面,触发、阈值或事件由感测/测量的击发力限定。根据其它方面,触发、阈值或事件由与感测/测量的击发力相关的参数限定。
仍然见图106,在端部执行器300处或附近的机动外科器械6900包括传感器设备6950,在一些情况下,该传感器设备联接到轴组件200或闭合管260。传感器设备6950可包括一个或多个传感器,其被配置成能够提供关于手术部位处存在的不同组织和/或材料的信息。
如在本公开中通篇使用的,按钮表示用于控制机器或工艺的某些方面的开关机构。按钮可由硬质材料(比如通常为塑料或金属)制成。其表面可以形成或成型为能容纳人的手指或手,从而能够容易地压下或推压。按钮可以是最常见的偏置开关,即使很多非偏置按钮(由于它们的物理属性)需要弹簧以恢复到它们的未被推压状态。术语“推压”按钮可包括按压、压下、点压和冲压。
参见图107,图示7200示出了根据一些方面,本公开的各种外科器械的端部执行器还可以或任选地包括缝合器机构。端部执行器的钳口可以形成缝合器和砧座机构。例如,底部钳口7204可包括用于钉仓的狭槽,该钉仓包括多排钉7206,而顶部钳口7202用作砧座,以便一旦击发就使钉就位。另外,在一些方面,切割元件7208(诸如刀片)可包括在底部钳口7204的中间。
参见图108,图示7300示出了使用端部执行器的切割和扣紧元件并且由一个或多个激光传感器辅助的根据外科手术中涉及的本公开的医疗装置的示例性场景。这里,端部执行器用于切割组织7305。钳口7202、7204可以钩在组织上,并且切割元件7208可以被击发以在组织7305中形成接缝,如图所示。还示出了传感器设备6950,在这种情况下,联接到轴6912并且被配置成能够将激光发射到组织7305上,如箭头所示。在这种情况下,传感器设备6950可以被配置成能够测量组织7305中的精确位置处的血流量。如图所示,组织7305可包括不同厚度的血管7310、7315,以及其它类型的非血管7320,诸如肌肉组织等。基于检测来自传感器设备6950的血流速率,各种类型的组织可以表现出不同的血流速率,从而使外科医生能够更好地确定正在操作什么类型的组织。
作为示例,从传感器设备6950发射的激光可以在到达更加坚固的物质时折射,如组织7305的部分。传感器设备6950中的接收器可以被配置成能够接收一些折射光。如果激光指向血液流动的血管,则可以跟踪血红细胞的运动。这可以基于测量激光何时返回到接收器的定时的变化。例如,传感器设备6950可以在第一时刻击发光束,并记录接收器检测到光反弹的时间。然后,可以在相同位置处的第二时刻处击发第二光束。如果该位置包括可辨别的血液流动区域,诸如在明显的血管中,那么到达血细胞的距离可能由于血细胞的流动而微小地改变。然后,第二光束可以具有到达接收器的不同时间。如果是这样,可以得出结论,端部执行器位于明显的血管附近。换句话讲,传感器设备6950可以采用类似多普勒的原理来测量手术部位处的各个点处的血流量。
此外,在一些方面,可以在施加手术部位处的组织压缩变化之后进行组织类型的确定。例如,如图示7300中所示的端部执行器的钳口7202、7204可以首先打开,如图所示,并且可使用传感器设备6950的激光进行第一血流测量。然后,钳口7202、7204可以压缩组织7305,从而在手术部位处引起更高的血压。这可能导致血管增加血流速度。因此,当采用传感器设备6950进行第二次激光测量时,由于血液流动得更快或者由于血细胞密度变化引起的不同折射率的光,第二定时测量可能与第一次测量不同。相反,在压缩组织7305之后,如果存在其它组织并且传感器设备6950指向非血管组织,则由于其它类型组织的不同物理特性,定时测量的变化可能不同。换句话讲,在一些方面,可以针对手术部位处的不同类型的组织确定一种定时特征。这样,可以测量血管中的血流,并且在一些情况下可以确定不同类型的组织。
基于定时测量的这些原理也可以应用于可能存在于手术部位处的不同材料。例如,患者中的金属结构可以表现出不同的光折射图案,以及不同的定时测量。塑料、硅树脂、金属油墨,或甚至受损或患病的组织可能表现出不同的折射特性。传感器设备6950可以被配置成能够检测这些测量值并最终允许医疗装置或其它卸载的处理器确定来自传感器设备6950的激光指向何种材料。
在确定手术部位处存在何种类型的组织或其它材料之后,外科医生可以更好地知道将端部执行器放置在何处以执行期望的外科手术。例如,外科医生可能希望避免夹紧金属结构、血管或其它人造植入物。相反,外科医生可能想要肯定地识别某些组织,诸如肌肉组织、或患病或癌组织。
在一些方面,传感器设备6950可以另选地或附加地包括其它类型的传感器。例如,传感器设备6950可以包括近红外光谱仪(NIRS),而不仅仅是具有单一频率的光的激光器,以更全面地确定手术部位处的各种类型的材料。通常,光谱仪被设计成在几乎任何类型的材料的可见光谱中产生独特的光吸收特征,其中每种材料固有地以不同的组合吸收不同波长的光。NIRS设备现在可使用小外形尺寸,现在可以小到足以连接到医疗装置的远侧端部。可以校准或训练该装置以学习各种组织和不同材料的不同光特征图,使得当在外科手术期间使用NIRS时,可以比较手术中拾取的实际特征图以识别存在于手术部位处的组织或材料的类型。
另外,近红外光谱可用于化学传感和检测异常组织特征。例如,使用具有类似NIRS的装置的传感器设备6950可以在患者的细胞中检测到成比例的钙或钠量。甚至可以检测到成比例的水量。通信地联接到传感器设备6950的信号处理器可以被配置成能够“解开”由存在的不同生理材料表现出的差异特征图及其比例。这样,表现出不同于可接受的特征图范围的特征的分析组织可以帮助医生检测异常组织,或甚至确定特定缺陷。例如,这些方法可以使医生能够在手术部位的各种组织中发现异常高水平的钠或钙。这些类型的指示器也可以用于确定患病组织,因为与正常组织相比,患病组织可以表现出特定的特征。信号处理器可以是如本文结合图15至图17B描述的控制器。
此外,这些类型的适应症还可以帮助调节用于凝结和密封组织的能量的量,因为当在组织上操作时,钙和其它矿物质的水平可以影响电导率和阻抗测量。因此,在一些方面,由传感器设备6950获得的读数可以被馈送到反馈系统,用于改变通过端部执行器施加到手术部位的密封能量的水平。也就是说,基于对至少一些组织的化学组成的分析,可以将成比例的能量的量施加到端部执行器以基于主体组织中确定的阻力量引起凝结。
在一些方面,使用NIRS和至少一种波长一致的激光的组合可用于感测手术部位处组织的血管分布程度。虽然NIRS可能能够确定组织类型,但是血管厚度或一般血流量可以通过上述多普勒原理和/或折射和吸收水平来确定。因此,多个传感器的组合可以向外科医生提供甚至更多信息。
在一些方面,传感器设备150可以另选地或附加地包括单色光投影仪,诸如LED光源,其可以用于识别各种类型的组织,以及照亮轮廓并去除手术部位处的阴影。例如,发射蓝光的LED光源可具有形状因子,以将光聚焦在平行于轴6912的圆柱形柱中。已知不同类型的组织(包括患病组织)吸收和反射不同的单色光。因此,当该圆柱形光柱照射到手术部位处的圆形区域上时,外科医生可能能够区分组织外观的差异,以将各种组织彼此区分开。另外,由于其它类型材料的各种吸收和折射特性,该技术还可用于潜在地识别钙化、纤维组织、重塑或瘢痕组织以及其它疾病状态。组织的折射和吸收特征可以基于表面观察和组织的下层结构。例如,更密集的组织体积(诸如肌肉纤维,例如与癌细胞形成对比)可以表现出不同的折射特征。此外,使用单色光源可以允许外科医生在组织中看到更厚或者更难以在外科腔中辨别的阴影。
在一些方面,可使用其它单色光谱,诸如近UV或近IR,并且可以与其它单色光源组合使用以照亮关于组织和其它材料的不同特性。在一些方面,传感器设备6950可以被配置成能够切换到不同的发光模式,这与可以容易地改变颜色的已知LED灯不同。
在一些方面,传感器设备6950可以另选地或附加地包括热成像传感器,用于测定手术部位处的红外热图案的水平。异常高水平的红外读数可能是炎症的迹象,这可能是生病或疾病的主要指标。这些迹象可以指出许多潜在的问题,诸如心血管疾病、肺病、关节炎、糖尿病甚至癌症。
此外,可使用多种数据组合来创建更复杂的评估。例如,除了使用所描述的任何或所有示例传感器的组合之外,端部执行器本身可配备有足以确定在手术部位处对特定组织进行操作所需的物理阻力或力的水平的传感器。例如,电阻传感器可以安装在钳口7202、7204中的一个或两个中,以帮助检测金属物体。当钳口闭合时,意外的阻力下降可能表示短路,这表明在钳口内夹持有大的金属物体。可以组合这些各种传感器以产生关于所讨论的组织的甚至更全面的特征图。
在一些方面,传感器设备6950也可以包括用于提供其发现的可见指示符的能力,以便容易地使外科医生能够区分手术部位处存在何种类型的材料。例如,如果传感器设备6950用于测量血流量并且确定被检查的特定区域填充有大血管,则传感器设备6950可以被配置成能够发射响应以指示其发现的激光。例如,传感器设备6950的激光器部分可以被配置成能够发射虚线的光脉冲,从而向外科医生提供警告以避免损坏该区域。相反,激光器部分可以被配置成能够响应于确定检查区域不包含大血管而发射稳定的激光流。作为另一个示例,激光点状图案的频率可以根据某些特定的生理特征而改变,诸如血流速率或血管数量等。因此,作为一个示例,逐渐更稳定或更粗的线可以指示更安全的操作区域。当然,其它类型的发光模式可以用作视觉指示器,包括反向使用的指示器,并且方面不限于此。在其它情况下,显示屏可以通信地联接到传感器设备6950和信号处理器,使得显示器可以提供其发现的文本信息。
图109为包括医疗器械6900(图106)的外科系统7400的框图,该医疗器械具有马达驱动的部件和一个或多个传感器,以更好地帮助理解手术部位中存在的组织和其它材料的类型。根据一些方面,外科器械联接到发生器有线电源7412(或者任选地具有内部发生器7414)。外科系统7400示出了医疗器械的内部电路的部件。图109描述了如何将能量传递到端部执行器7418和通信地联接到电路的传感器7420以及在一些情况下端部执行器7418的部分的示例。在某些情况下,马达驱动的外科器械6900可包括联接到外部有线发生器7412或内部发生器7414的微控制器7404。外部发生器7412或内部发生器7414可以联接到A/C电源,或者可以是电池驱动的或其组合。例如,与马达驱动的外科器械100和/或发生器元件7412、7414相关联的电和电子电路元件可以由控制电路板组件支撑。微控制器7404通常可包括存储器7406和可操作地联接到存储器7406的微处理器7422(“处理器”)。处理器7422可控制马达驱动器408电路,该电路通常用于控制马达7410的位置和速率。马达7410可以被配置成能够控制能量传输到外科器械的端部执行器7418处的钳口。在某些情况下,处理器7422可以向马达驱动器7408发信号以停止和/或禁用马达7410。在某些情况下,处理器7422可控制单独的马达超控电路,该电路可包括马达超控开关,该马达超控开关可在操作外科器械的过程中,响应于来自处理器7422的超控信号而停止和/或停用马达7410。另外,处理器7422可以被配置成能够控制传感器7420的操作,以根据上述任何传感器操作动作,前提是存在用于执行此类操作的合适传感器。处理器7422可以控制从外部电源7412和/或内部电源7414施加到传感器7420的电量。处理器7422还可以通信地联接到一个或多个显示器7416,这些显示器被配置成能够使得信息的显示足以通知外科医生从传感器7420获得的相关数据。应当理解,本文使用的术语“处理器”包括任何合适的微处理器、微控制器,或者将计算机的中央处理单元(CPU)的功能结合到一个集成电路或最多几个集成电路上的其它基础计算装置。处理器是多用途的可编程装置,该装置接收数字数据作为输入,依据其存储器中存储的指令来处理输入,然后提供结果作为输出。因为处理器具有内部存储器,所以是顺序数字逻辑的示例。处理器的操作对象是以二进制数字系统表示的数字和符号。
在一些情况下,处理器7422可以是任一种单核或多核处理器,诸如已知的由TexasInstruments生产的商品名为ARM Cortex的那些。在一些情况下,本公开的外科器械的任一种可包括安全处理器,诸如包括两个基于微控制器的系列(诸如TMS570和RM4x)的安全微控制器平台(已知同样由Texas Instruments生产的商品名为Hercules ARM Cortex R4)。然而,可不受限制地采用微控制器和安全处理器的其它合适的替代物。在一个示例中,安全处理器可被构造能够专门用于IEC 61508和ISO 26262安全性至关重要的应用、以及其它应用,以提供先进的集成安全特征结构,同时提供可缩放的性能、连接性和存储器选项。
作为一些示例,微控制器7404可为例如购自Texas Instruments的LM 4F230H5QR。在至少一个示例中,Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核包括高达40MHz的256KB单周期闪速存储器7406或其它非易失性存储器的芯片上存储器、40MHz以上的用于提高性能的预取缓冲区、32KB单周期串行随机存取存储器(SRAM)、加载有软件的内置只读存储器(ROM)、2KB电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、一个或多个具有12个模拟输入通道的12位模/数转换器(ADC)、以及随时可用于产品数据表的其它特征结构。其它微控制器可以容易地替代用于马达驱动的外科器械6900。因此,本公开不应限于这一上下文。
在某些情况下,马达驱动的外科器械7400可以包括固件、软件硬件或其任何组合实现的一个或多个嵌入式应用程序。在某些情况下,马达驱动的外科器械7400可包括各种可执行模块,诸如软件、程序、数据、驱动器和/或应用程序接口(API)。
参见图110,图示7500提供了如何使用本文描述的多普勒原理确定血流测量值的一些方面的图形解释。出于举例说明的目的,根据一些方面,仅示出了激光发射器和检测器7505,尽管如前所述,传感器设备的这个和其它部分可以附接到医疗装置。这里,激光和检测器设备7505被配置成能够将激光发射到一定体积的皮肤组织7510中。如图所示,皮肤组织7510包括许多不同类型的细胞和血管。通过采用上述多普勒原理,激光和检测器设备7505可以被配置成能够确定顶层皮肤下面的血管的存在。在这种情况下,血管对应于皮肤组织7510中癌性黑素瘤细胞的存在。基底皮肤细胞层上方的血管的存在可以指示身体正在向通常不应该供应血液的皮肤区域供应血液。因此,虽然在大多数情况下,激光和检测器设备7505可以向皮肤发射激光并且不检测皮肤细胞的运动,检测发射的任何细胞中的多普勒频移可以指示血管的存在,并且因此指示异常情况。
参见图111,图示7600提供了可用于执行本文描述的一些激光技术的一些光学物理的示例。如图所示,激光器605可以被配置成能够发射激光,该激光可以在到达患者的目标组织7610之前通过透镜A聚焦或准直。可靠量的光可以以特定角度折射并通过透镜B聚焦并进入接收器7615。接收器7615然后可以被配置成能够通过光的像素化阵列形式的模数转换器将信息传递到计算机。该阵列可以提供每个像素的强度测量。如图所示,图示7600提供了用于发射光并在接收器7615中捕集光的示例维度集。在其它情况下,可使用相同的比例,同时可以改变尺寸以进行修改来安装在医疗装置中。在其它情况下,可以修改接收器捕集激光的入射角,并且可以相应地调整距离,以便适应安装到医疗装置上。
根据本公开的一个或多个方面,图112A是灰度图形描绘,图112B是使用本文描述的热成像技术的红外读数的线图形描绘。参见图112A、图112B,图示7700提供了根据一些方面的使用本文描述的热成像技术的红外读取的图形示例。这里,中间区域7705示出了与周围区域7710相比更高的强度读数。当以颜色示出时,中间区域7705示出橙色和红色强度区域,而周围区域7710示出冷蓝色。较低强度区域可以表示正常量值的IR特征,而具有较高强度颜色的中间区域7705可以表示升高的温度和/或血流量。因此,使用这些成像技术仅作为一些示例并且是传感器设备的一部分,本公开的方面可以允许更好的视觉和/或文本辅助,以帮助外科医生识别手术部位处的不同类型的材料和潜在的问题区域。
虽然上文说明已列举了各种细节,但应当理解,可以在没有这些具体细节的情况下实施电动外科器械的各个方面。例如,为简洁和清楚起见,以框图的形式示出了选择的方面,而不是详细地示出。本文提供的详细描述的某些部分可以呈现为对存储在计算机存储器中的数据进行操作的指令。本领域的技术人员用此类描述和表达向本领域的其它技术人员描述和传达它们的工作要旨。通常,算法是指导致所需结果的步骤的自相容序列,其中“步骤”是指物理量的操纵,物理量可以(但不一定)采用能被存储、转移、组合、比较和以其它方式操纵的电或磁信号的形式。常用于指这些信号,如位、值、元素、符号、字符、术语、数字等。这些和类似的术语可与适当的物理量相关联并且仅仅是应用于这些量的方便的标签。
尽管本文已描述了各个方面,但可以实施并且本领域的技术人员将会想到这些方面的许多修改形式、变型形式、替换形式、改变形式和等效形式。另外,在公开了用于某些部件的材料的情况下,也可使用其它材料。因此,应当理解,上述具体实施方式和所附的权利要求旨在涵盖属于本发明所公开的方面的范围内的所有此类修改形式和变型形式。以下权利要求旨在涵盖所有此类修改形式和变型形式。
在一般意义上,本领域的技术人员将会认识到,可以用多种硬件、软件、固件或它们的任何组合单独和/或共同实施的本文所述的多个方面可以被看作是由多种类型的“电子电路”组成。因此,如本文所用,“电子电路”包括但不限于具有至少一个离散电路的电子电路、具有至少一个集成电路的电子电路、具有至少一个专用集成电路的电子电路、形成由计算机程序配置的通用计算设备的电子电路(例如,至少部分地实施本文描述的方法和/或设备的由计算机程序配置的通用计算机,或至少部分地实施本文描述的方法和/或设备的由计算机程序配置的处理器)、形成存储器设备(例如,形成随机存取存储器)的电子电路,和/或形成通信设备(例如,调制解调器、通信开关或光电设备)的电子电路。本领域的技术人员将会认识到,可以模拟或数字方式或它们的一些组合实施本文所述的主题。
上述具体实施方式已通过使用框图、流程图和/或示例阐述了装置和/或方法的各个方面。只要此类框图、流程图和/或示例包含一个或多个功能和/或操作,本领域的技术人员就要将其理解为此类框图、流程图或示例中的每个功能和/或操作都可以单独和/或共同地通过多种硬件、软件、固件或实际上它们的任何组合来实施。在一个方面,本文描述的主题的若干部分可以通过专用集成电路(ASIC)、现场可编程门阵列(FPGA)、数字信号处理器(DSP)或其它集成格式来实施。然而,本领域的技术人员将会认识到,本文所公开的方面的一些方面可以作为在一台或多台计算机上运行的一个或多个计算机程序(如,作为在一个或多个计算机系统上运行的一个或多个程序),作为在一个或多个处理器上运行的一个或多个程序(如,作为在一个或多个微处理器上运行的一个或多个程序),作为固件,或作为实际上它们的任何组合全部或部分地在集成电路中等效地实现,并且根据本发明,设计电子电路和/或编写软件和/或硬件的代码将在本领域技术人员的技术范围内。
另外,本领域的技术人员将会认识到,本文所述主题的机制能够作为多种形式的程序产品进行分布,并且本文所述主题的示例性方面适用,而不管用于实际进行分布的信号承载介质的具体类型是什么。信号承载介质的示例包括但不限于如下:可录式媒体,诸如软盘、硬盘驱动器、光盘(CD)、数字视频光盘(DVD)、数字磁带、计算机存储器等;和传输式介质,诸如数字和/或模拟通信介质(例如,光纤缆线、波导、有线通信链路、无线通信链路(例如,发射器、接收器、传输逻辑、接收逻辑)等)。
概括地说,已经描述了由采用本文所述的概念产生的许多有益效果。为了举例说明和描述的目的,已经提供了一个或多个方面的上述说明。这些具体实施方式并非意图为详尽的或限定到本发明所公开的精确形式。可以根据上述教导内容对本发明进行修改或变型。所选择和描述的一个或多个方面是为了示出本发明的原理和实际应用,从而使得本领域的普通技术人员能够利用多个方面,在适合设想的具体应用的情况下进行各种修改。与此一同提交的权利要求书旨在限定完整范围。
Claims (20)
1.一种外科器械,所述外科器械包括:
柄部组件;
轴,所述轴联接到所述柄部组件;
端部执行器,所述端部执行器通过所述轴通信地联接到所述柄部组件并包括第一钳口和第二钳口,所述柄部组件被构造成能够操纵所述第一钳口和所述第二钳口,以限定打开位置和闭合位置;以及
传感器设备,所述传感器设备在所述轴的远侧端部处,所述传感器设备包括至少一个传感器以及至少一个接收器,所述传感器被配置成能够将传感器信号传输到手术部位处的患者组织上,所述接收器被配置成能够基于所述传感器信号的传输来接收所述患者组织的传感器数据。
2.根据权利要求1所述的外科器械,所述外科器械还包括处理器,所述处理器被配置成能够访问所述传感器数据,并且促使基于所述传感器数据显示患者组织的文本分析或图形分析。
3.根据权利要求1所述的外科器械,其中,所述至少一个传感器包括激光传感器,并且所述传感器信号包括激光。
4.根据权利要求3所述的外科器械,其中,所述传感器数据包括基于所述激光在所述患者组织上的折射入射的所述激光的强度的量度。
5.根据权利要求3所述的外科器械,其中,所述传感器信号包括传输到所述患者组织的第一激光脉冲和第二激光脉冲,所述第一脉冲和所述第二脉冲分别在第一次和第二次传输;并且所述传感器数据包括基于所述第一脉冲的折射的第一定时测量和基于所述第二脉冲的折射的第二定时测量。
6.根据权利要求5所述的外科器械,所述外科器械还包括处理器,所述处理器被配置成能够访问所述第一定时测量和所述第二定时测量,并且计算所述两个测量之间的定时差值。
7.根据权利要求6所述的外科器械,其中,所述传感器设备还被配置成能够基于所计算的所述第一定时测量和所述第二定时测量之间的所述定时差值的量值来传输具有重复响应模式的激光信号。
8.根据权利要求5所述的外科器械,其中,所述第二定时测量还基于所述第一钳口和所述第二钳口对所述患者组织的压缩,所述压缩促使所述患者组织在所述第二脉冲的测量位置处扩张。
9.根据权利要求1所述的外科器械,其中,所述至少一个传感器包括近红外光谱仪传感器,并且所述传感器信号包括可见光谱中的光的多光谱阵列。
10.根据权利要求9所述的外科器械,其中,所述传感器数据包括照射到所述患者组织上的多光谱阵列的光谱仪读数。
11.根据权利要求10所述的外科器械,所述外科器械还包括处理器,所述处理器被配置成能够访问所述传感器数据并基于所述光谱仪读数提供所述患者组织的物理组成和/或化学组成的分析。
12.根据权利要求11所述的外科器械,其中,所述处理器还被配置成能够基于所述光谱仪读数确定所述患者组织中的化学浓度的异常比例。
13.根据权利要求1所述的外科器械,其中,所述至少一个传感器包括发光二极管(LED),并且所述传感器信号包括从所述发光二极管(LED)发射的准直单色光束。
14.根据权利要求1所述的外科器械,其中,所述至少一个传感器包括热成像传感器,并且所述传感器信号包括以二维数组表达的所述患者组织的红外数据。
15.根据权利要求1所述的外科器械,其中,所述端部执行器还包括电阻传感器,所述电阻传感器被配置成能够测量所述第一钳口和所述第二钳口之间的电阻水平。
16.一种外科系统,所述外科系统包括:
外科器械,所述外科器械包括:
柄部组件;
轴,所述轴联接到所述柄部组件;
端部执行器,所述端部执行器通过所述轴通信地联接到所述柄部组件并包括第一钳口和第二钳口,所述柄部组件被构造成能够操纵所述第一钳口和所述第二钳口,以限定打开位置和闭合位置;以及
传感器设备,所述传感器设备在所述轴的远侧端部处,所述传感器设备包括至少一个传感器以及至少一个接收器,所述传感器被配置成能够将传感器信号传输到手术部位处的患者组织上,所述接收器被配置成能够基于所述传感器信号的传输来接收所述患者组织的传感器数据;以及
图形显示器,所述图形显示器通信地联接到所述外科器械,并且被配置成能够显示所述患者组织的所述传感器数据的图形表示。
17.根据权利要求16所述的外科系统,所述外科系统还包括处理器,所述处理器被配置成能够访问所述传感器数据,并且促使基于所述传感器数据显示患者组织的文本分析或图形分析。
18.根据权利要求16所述的外科系统,其中,所述至少一个传感器包括激光传感器,并且所述传感器信号包括激光。
19.根据权利要求18所述的外科系统,其中,所述传感器数据包括基于所述激光在所述患者组织上的折射入射的所述激光的强度的量度。
20.一种不具有暂时信号的计算机可读介质,包括当由处理器执行时促使所述处理器执行包括以下操作的指令:
访问源自传感器信号传输到所述患者组织上的患者组织的传感器数据;所述传感器信号由外科器械的传感器设备传输;
基于所述传感器数据确定所述患者组织的物理组成或化学组成;以及
促使显示所述患者组织的所述传感器数据的图形表示。
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PCT/US2017/026334 WO2017180435A2 (en) | 2016-04-15 | 2017-04-06 | Surgical instrument with detection sensors |
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EP3231377A2 (en) | 2017-10-18 |
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US20210085317A1 (en) | 2021-03-25 |
JP2019522499A (ja) | 2019-08-15 |
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JP7086857B2 (ja) | 2022-06-20 |
US10426467B2 (en) | 2019-10-01 |
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