CN104434248B - 区分手术器械内的组织夹紧和机械阻碍的设备和方法 - Google Patents

区分手术器械内的组织夹紧和机械阻碍的设备和方法 Download PDF

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CN104434248B
CN104434248B CN201410479971.9A CN201410479971A CN104434248B CN 104434248 B CN104434248 B CN 104434248B CN 201410479971 A CN201410479971 A CN 201410479971A CN 104434248 B CN104434248 B CN 104434248B
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保劳格·萨普雷
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    • A61B2017/00017—Electrical control of surgical instruments
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
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Abstract

提供了一种手术器械。所述手术器械包括：手柄组件；钳夹组件，其包括包含多个吻合钉的吻合钉钉仓和在发射时使所述多个吻合钉成形的砧座；驱动组件，其至少部分地位于所述手柄内并且连接至钳夹组件和锁定机构；电动机，其布置在手柄组件内并且被操作性地联接至驱动组件；以及控制器，其被操作性地联接至电动机，所述控制器被配置为控制至所述电动机的电流的供给并且监视所述电动机的电流消耗，其中所述控制器被进一步配置为响应于所述电流消耗的变化率而终止至所述电动机的电流的供给，所述电流消耗的变化率指示所述钳夹组件、所述驱动组件或所述电动机中的至少一个的机械极限。本发明提供了区分手术器械内的组织夹紧和机械阻碍的设备和方法。

Description

区分手术器械内的组织夹紧和机械阻碍的设备和方法
相关申请的交叉引用
本申请要求享有提交于2013年9月18日的序号为61/879,445的美国临时专利申请的利益和优先权，其全部内容通过引用合并于此。
技术领域
本公开涉及用于执行内窥镜检查的手术操作的手术设备、装置和/或系统及其使用方法。更具体地，本公开涉及机电的、手持式手术设备、装置和/或系统，其被配置为与用于夹紧、切割和/或吻合组织的可拆卸的一次性末端执行器和/或单次使用的末端执行器一起使用。
背景技术
许多手术装置的生产商已经开发出具有适用于操作和/或操纵机电手术装置的专用驱动系统的产品线。在许多实例中，所述机电手术装置包括可重复使用的手柄组件，以及一次性末端执行器或单次使用的末端执行器。所述末端执行器可以在使用前选择性地连接到所述手柄组件上，并且然后，在使用后再从所述手柄组件断开连接以便于被处置或在一些实例中被消毒以重复使用。
许多这种机电手术装置包括复杂的驱动部件，其利用多种可接收用户输入的用户接口(例如，控制器)来控制装置并给用户提供反馈。为防止驱动机构的致动超过机械极限，多种开关和传感器被用来检测手术装置的运转状态。在装置和末端执行器内包括多重开关和/或传感器呈现了多种问题。另外，成本或其他考虑阻止了这种装置的使用。因此，需要具有无需依赖遍及手术装置布置的多重机械极限传感器和/或开关就能够检测机械极限的安全机构的系统和设备。
发明内容
根据本公开的一个实施例提供了一种手术器械。所述手术器械包括：手柄组件；钳夹组件，其包括包含多个吻合钉的吻合钉钉仓和在发射时使所述多个吻合钉成形的砧座；驱动组件，其至少部分地位于所述手柄内并且被连接至所述钳夹组件和锁定机构；电动机，其被布置在所述手柄组件内并且被操作性地联接至所述驱动组件；以及控制器，其被操作性地联接至所述电动机，所述控制器被配置为控制至所述电动机的电流的供给并且监视所述电动机的电流消耗，其中所述控制器被进一步配置为响应于所述电流消耗的变化率而终止至所述电动机的电流的供给，所述电流消耗的变化率指示所述钳夹组件、所述驱动组件、或所述电动机中的至少一个的机械极限。
根据上述实施例的一个方案，所述控制器被进一步配置为通过判定电流消耗的变化率是否在第一范围外来判定电动机电流是否不稳定。
根据上述实施例的一个方案，所述控制器被进一步配置为通过判定电流消耗的变化率是否在第二范围内来判定电动机电流是否稳定，其中所述第二范围在所述第一范围内。
根据上述实施例的一个方案，所述控制器被进一步配置为存储在第二范围内的电流消耗样本的稳定计数(stability counter)。
根据上述实施例的一个方案，所述控制器判定如果稳定计数高于预先确定的稳定临界值时，电动机电流是否稳定。
根据上述实施例的一个方案，所述控制器被进一步配置为：通过判定所述电动机电流是否稳定以及判定电流消耗的变化率是否在第三范围内来判定所述电动机是否达到机械极限。
根据上述实施例的一个方案，所述第三范围在所述第一范围内并且高于所述第二范围。
根据上述实施例的一个方案，所述控制器被进一步配置为存储在所述第三范围内的电流消耗样本的故障计数(event counter)。
根据上述实施例的一个方案，所述控制器判定如果故障计数高于预先确定的故障临界值，所述电动机是否达到机械极限。
根据本公开的另一个实施例，提供了一种手术器械。手术器械包括：手柄组件；钳夹组件，其包括包含多个吻合钉的吻合钉钉仓和在发射时使所述多个吻合钉成形的砧座；驱动组件，其至少部分地位于所述手柄内并且被连接至所述钳夹组件和锁定机构；电动机，其被布置在所述手柄组件内并且被操作性地联接至所述驱动组件；以及控制器，其被操作性地联接至所述电动机，所述控制器被配置为基于通过所述电动机的电流消耗的变化率来判定所述电动机是否已经达到机械极限，所述电流消耗的变化率指示机械极限。
根据上述实施例的一个方案，所述控制器被进一步配置为通过判定电流消耗的变化率是否在第一范围外来判定电动机电流是否不稳定。
根据上述实施例的一个方案，所述控制器被进一步配置为通过判定电流消耗的变化率的多个样本是否在第二范围内来判定电动机电流是否稳定。
根据上述实施例的一个方案，所述控制器被进一步配置为存储在第二范围内的电流消耗样本的稳定计数。
根据上述实施例的一个方案，所述控制器判定如果稳定计数高于预先确定的稳定临界值，电动机电流是否稳定。
根据上述实施例的一个方案，所述控制器被进一步配置为通过判定电动机电流是否稳定以及判定电流消耗的变化率的多个样本是否在第三范围内来判定电动机是否达到机械极限。
根据上述实施例的一个方案，所述第二和第三范围在所述第一范围内，并且所述第三范围高于所述第二范围。
根据上述实施例的一个方案，所述控制器被进一步配置为存储在第三范围内的电流消耗样本的故障计数。
根据上述实施例的一个方案，所述控制器判定如果故障计数高于预先确定的故障临界值，电动机是否达到机械极限。
根据本公开的另一个实施例，提供了用于控制手术器械的方法。所述方法包括：监视电动机的电流消耗，其中，所述电动机被联接至用于致动钳夹组件的驱动组件；计算电流消耗的变化率；以及基于电动机的电流消耗的变化率来判定电动机是否已经达到机械极限。
根据上述实施例的一个方案，所述方法进一步包括判定电流消耗的变化率是否在第一范围外从而判定电动机电流是否不稳定。
根据上述实施例的一个方案，所述方法进一步包括判定电流消耗的变化率的多个样本是否在第二范围内从而判定电动机电流是否稳定。
根据上述实施例的一个方案，所述方法进一步包括：存储在第二范围内的电流消耗样本的稳定计数；并且判定如果稳定计数高于预先确定的稳定临界值，电动机电流是否稳定。
根据上述实施例的一个方案，所述方法进一步包括：通过判定电动机电流是否稳定以及电流消耗的变化率的多个样本是否在第三范围内从而判定电动机是否达到机械极限。
根据上述实施例的一个方案，所述第二和第三范围在所述第一范围内，并且所述第三范围高于所述第二范围。
根据上述实施例的一个方案，所述方法进一步包括：存储在所述第三范围内的电流消耗样本的故障计数；并且判定如果故障计数高于预先确定的故障临界值，电动机是否达到机械极限。
附图说明
本文将通过参照附图描述本公开的实施例，其中：
图1是根据本公开的包括手术器械、接合器以及末端执行器的机电手术系统的分解的立体图；
图2是根据本公开的图1的手术器械的立体图；
图3是根据本公开的图1的手术器械的部件分开的立体图；
图4是根据本公开的图1的手术器械的电池的立体图；
图5是根据本公开的图1的手术器械的部分分解的俯视图；
图6是根据本公开的图1的手术器械的正视立体图，其中，所述接合器从所述手术器械分离；
图7是根据本公开的图1的手术器械沿着图2的7-7取得的侧剖视图；
图8是根据本公开的图1的手术器械沿着图2的8-8取得的俯视剖视图；
图9是根据本公开的图1的末端执行器的部件分开的立体图；
图10是根据本公开的图1的手术器械的示意图；
图11是被存储在根据本公开的图1的手术器械的内存内的电动机电流值的示意图；
图12是用于控制根据本公开的图1的手术器械的方法的流程图；
图13至图15是当被本公开的方法控制时，手术器械的电动机电流的绘图；以及
图16是用于控制根据本公开的另一个实施例的图1的手术器械的方法的流程图。
具体实施方式
根据本公开的实施例，手术系统总体被指定为10，并且所述手术系统呈动力手持式机电器械的形式，且所述动力手持式机电器械被配置为选择性地将多个不同的末端执行器附接至其上，所述末端执行器中的每一个均被配置为用于通过所述动力手持式机电手术器械来致动和操纵。
如图1所示，手术器械100被配置为选择性连接接合器200，并且，依次地，接合器200被配置为选择性连接末端执行器或单次使用的装载单元300。
如图1至图3所示，手术器械100包括手柄壳体102，手柄壳体102具有下壳体部104、中间壳体部106以及上壳体部108，其中，中间壳体部106从下壳体部104延伸出和/或被支撑在下壳体部104上，上壳体部108从中间壳体部106延伸出和/或被支撑在中间壳体部106上。中间壳体部106和上壳体部108被分离成远侧半体110a和近侧半体110b，其中，远侧半体110a与下壳体部104一体式形成并且从下壳体部104延伸出，而近侧半体110b能够通过多个紧固件与远侧半体110a连接。当结合时，远侧半体110a和近侧半体110b限定手柄壳体102，在手柄壳体102内具有安置了电路板150和驱动机构160的空腔102a。
可从图2和图3看出，远侧半体110a和近侧半体110b沿着横切上壳体部108的纵向轴线“X”的平面被分割。手柄壳体102包括垫圈112，垫圈112完全地环绕远侧半体110a和/或近侧半体110b的边缘延伸并且被插入远侧半体110a和近侧半体110b之间。垫圈112密封远侧半体110a和近侧半体110b的周边。垫圈112的作用是在远侧半体110a和近侧半体110b之间建立气密的密封，使电路板150和驱动机构160免于杀菌和/或清洁操作。
如此，手柄壳体102的空腔102a沿着远侧半体110a的周边被密封，而近侧半体110b被配置为使电路板150和驱动机构160在手柄壳体102内的组装变得更加容易且更加高效。
手柄壳体102的中间壳体部106提供了安置电路板150的壳体。电路板150被配置为控制手术器械100的多种操作，这将在下文中更详细地介绍。
手术器械100的下壳体部104限定了孔隙(未显示)，此孔隙形成在下壳体部104的上表面并位于中间壳体部106之下或之内。下壳体部104的孔隙提供了通道，电线152穿过所述通道以将安置在下壳体部104内的电气部件(例如，如图4所示的电池156，如图3所示的电路板154，等)与安置在中间壳体部106和/或上壳体部108内的电气部件(电路板150、驱动机构160等)电连通。
手柄壳体102包括布置在下壳体部104的孔隙内的垫圈103(未显示)，从而塞紧或密封下壳体部104的孔隙但是允许电线152从其中穿过。垫圈103的作用是在下壳体部104和中间壳体部106之间建立气密的密封，从而使电路板150和驱动机构160免于杀菌和/或清洁操作。
如图所示，手柄壳体102的下壳体部104提供了壳体，可再充电的电池156被可拆卸地布置在所述壳体内。电池156被配置为向手术器械100的任何电气部件供给电力。下壳体部104限定了空腔(未显示)，电池156被插入所述空腔。下壳体部104包括门105，门105枢轴地连接到下壳体部104用于闭合下壳体部104的空腔并且将电池156保持在所述空腔内。
参考图3和图5，上壳体部108的远侧半体110a限定了鼻形部或连接部108a。鼻椎体114被支撑在上壳体部108的鼻形部108a上。鼻椎体114由透明材料制成。照明构件116被布置在鼻椎体114内，从而穿过其可以看见照明构件116。照明构件116可以是发光二级管印刷电路板(LED PCB)。照明构件116被配置为以具有与独特的离散事件相关联的特定颜色图案的多种颜色照明。
手柄壳体102的上壳体部108提供了安置驱动机构160的壳体。如图5所示，驱动机构160被配置为驱动轴和/或齿轮部件来执行手术器械100的多种操作。特别地，驱动机构160被配置为驱动轴和/或齿轮部件从而选择性地使末端执行器300的工具组件304相对末端执行器300的近侧主体部302移动(参见图1和图9)，使末端执行器300相对手柄壳体102绕纵向轴线“X”(参见图2)旋转，使砧座组件306相对末端执行器300的钉仓组件308移动，和/或从末端执行器300的钉仓组件308内发射吻合和切割钉仓。
驱动机构160包括选择式齿轮箱组件162，其紧靠接合器200的近侧。选择式齿轮箱组件162的近侧具有功能选择模块163，功能选择模块163具有第一电动机164，第一电动机164的作用是选择性地移动选择式齿轮箱组件162内的齿轮元件使所述齿轮元件与具有第二电动机166的输入驱动部件165接合。
如图1至图4所示，并且如上所提到的，上壳体部108的远侧半体110a限定了连接部108a，其被配置为接收接合器200的对应的驱动联接组件210。
如图6至图8所示，手术器械100的连接部108a具有圆柱形的凹槽108b，当接合器200与手术器械100匹配时，凹槽108b接纳接合器200的驱动联接组件210。连接部108a容纳三个可旋转驱动连接器118、120、122。
如图6所示，当接合器200与手术器械100匹配时，手术器械100的可旋转驱动连接器118、120、122中的每一个驱动连接器与接合器200的对应的可旋转连接器套管218、220、222相联接。在这点上，对应的第一驱动连接器118和第一连接器套管218之间的交接，对应的第二驱动连接器120和第二连接器套管220之间的交接，以及对应的第三驱动连接器122和第三连接器套管222之间的交接都是键联接，以便于手术器械100的驱动连接器118、120、122中的每一个驱动连接器的旋转都会引起接合器200的对应的连接器套管218、220、222的对应的旋转。
手术器械100的驱动连接器118、120、122与接合器200的连接器套管218、220、222的匹配允许旋转力经由三个对应的连接器交接中的每一个连接器交接独立地传递。手术器械100的驱动连接器118、120、122被配置为被驱动机构160独立地旋转。在这点上，驱动机构160的功能选择模块163会选择由驱动机构160的输入驱动部件165来驱动手术器械100的驱动连接器118、120、122中的哪一个或哪几个。
因为手术器械100的驱动连接器118、120、122中的每一个驱动连接器与接合器200的对应的连接器套管218、220、222的交接都是键式的和/或基本上不可旋转的，当接合器200联接到手术器械100时，旋转力被选择性地从手术器械100的驱动机构160传递到接合器200。
手术器械100的驱动连接器118、120和/或122的选择性旋转允许手术器械100选择性地致动末端执行器300的不同功能。如下面更详细地讨论，手术器械100的第一驱动连接器118的选择性的且独立的旋转对应末端执行器300的工具组件304的选择性的且独立的打开和闭合，以及对应末端执行器300的工具组件304的吻合/切割部件的驱动。同样，手术器械100的第二驱动连接器120的选择性的且独立的旋转对应末端执行器300的工具组件304的横切纵向轴线“X”(参见图2)的选择性且独立的关节式运动。另外，手术器械100的第三驱动连接器122的选择性的且独立的旋转对应末端执行器300相对于手术器械100的手柄壳体102绕纵向轴线“X”(参见图2)的选择性的且独立的旋转。
如上所提到的并且如图5和图8所示，驱动机构160包括选择式齿轮箱组件162，以及安置在选择式齿轮箱组件162的近侧的功能选择模块163，功能选择模块163的作用是选择性地移动选择式齿轮箱组件162内的齿轮元件使所述齿轮元件与第二电动机166接合。这样，在特定时间，驱动机构160选择性地驱动手术器械100的驱动连接器118、120、122中的一个。
如图1至图3所示，手柄壳体102将控制组件107支撑在中间壳体部106的远侧表面或侧面上。控制组件107是功能完善的机械子组件，其在联接至器械100之前能够与器械100的其余部分分离地组装和测试。
控制组件107，与中间壳体部106协作，将一对手指致动的控制按钮124、126和一对摇杆装置128、130支撑在壳体107a内。控制按钮124、126分别被联接至延伸轴125、127。特别地，控制组件107限定了用于可滑动地接纳延伸轴125的上孔隙124a和用于可滑动地接纳延伸轴127的下孔隙126a。
关于手术器械100的构造和操作的详细讨论，可以参照申请号为13/331，047的共有美国专利申请，其全部内容通过引用合并于此。
参照图9，末端执行器300的驱动组件360包括挠性驱动轴364，挠性驱动轴364具有紧固到动力驱动梁365的远侧端以及近侧接合体368。接合体368包括限定肩370的梯状部。接合体368的近侧端包括正相对的向内延伸的指状件372。指状件372与中空的驱动构件374接合从而将驱动构件374牢固地紧固到轴364的近侧端上。驱动构件374限定近侧孔口，近侧孔口在末端执行器300被附接到接合器200的远侧联接器230时接纳接合器200的驱动管246(图1)的连接构件。
当驱动组件360在工具组件304内被向远侧推进时，驱动梁365的上梁在砧座板312和砧座盖310之间限定的通道内移动，而下梁在吻合钉钉仓305的通道内移动并且移动到承载器316的外表面的上方来闭合工具组件304并从其中发射吻合钉。
末端执行器300的近侧主体部302包括封装上壳体部301a和下壳体部301b的鞘或外管301。上壳体部301a和下壳体部301b封装关节式运动连接件366，关节式运动连接件366具有从末端执行器300的近侧端延伸的钩状近侧端366a。当末端执行器300被紧固到接合器200的远侧壳体232时，关节式运动连接件366的钩状近侧端366a与接合器200的联接钩(未显示)相接合。如上所述，当接合器200的驱动杆(未显示)被推进或缩回时，末端执行器300的关节式运动连接件366会在末端执行器300内被推进或缩回以使工具组件304相对于近侧主体部302的远侧端枢转。
如图9所示，工具组件304的钉仓组件308包括能够支撑在承载器316内的吻合钉钉仓305。吻合钉钉仓305限定了中央纵向狭槽305a，以及定位在纵向狭槽305a的每一侧上的三个线性排吻合钉保持狭槽305b。每一个吻合钉保持狭槽305b接纳单个吻合钉307和吻合钉推动器309的一部分。在操作器械100期间，驱动组件360与致动滑板350邻接并推动致动滑板350通过钉仓305。随着致动滑板移动通过钉仓305，致动滑板350的凸轮楔顺序地与吻合钉推动器309相接合，从而在吻合钉保持狭槽305b内竖直地移动吻合钉推动器309并从其中顺序地射出单个吻合钉307以靠着砧座板312成型。
末端执行器300还可以包括一个或多个机械锁定机构，例如在序号为5,071,052、5,397,046、5,413,267、5,415,335、5,715,988、5,718,359以及6,109,500的共有美国专利中所描述的机械锁定机构，上述专利的全部内容通过引用结合在此。
图10显示了器械100的另一个实施例。器械100包括电动机164。电动机164可以是任何配置为致动一个或多个驱动器(例如，图6的可旋转驱动连接器118、120、122)的电力的电动机。电动机164被联接至电池156，所述电池156可以是直流电池(例如，可再充电的铅基的、镍基的、锂离子基的电池等)、交直流变压器、或任何其他的适合提供电能至电动机164的电源。
电池156和电动机164被联接至布置在电路板154上的电动机驱动电路404，电路板154控制电动机164的操作，包括电能从电池156流向电动机164。驱动电路404包括配置为测量电动机164和电池156的运转状态的多个传感器408a、408b、…408n。传感器408a-n可包括电压传感器、电流传感器、温度传感器、遥感传感器、光学传感器、及其组合。传感器408a-408n可测量由电池156提供的电能的电压、电流以及其他电学特性。传感器408a-408n还可测量电动机164的按照每分钟的转数(RPM)的旋转速度、转矩、温度、电流消耗、以及其他运转特性。可通过测量电动机164的旋转来确定RPM。多种驱动轴(例如，图6的可旋转驱动连接器118、120、122)的位置可通过使用布置在轴内或邻近轴处的多种线性传感器来确定或从RPM测量来推定。在实施例中，在恒定的RPM下，可以基于电动机164的额定电流消耗来计算转矩。在另外的实施例中，驱动电路404和/或控制器406可测量时间并作为其函数处理上述数值(例如，包括积分和/或微分)以确定测量值的变化等。
驱动电路404还被联接至控制器406，控制器406可以是任何适合的逻辑控制电路，其适合于执行计算和/或根据一组指令运转，这将在下文中更详细地描述。控制器406可包括被可操作地连接至内存的中央处理单元，内存可包括临时类型内存(例如，RAM)和/或非临时类型内存(例如，可读取多种记忆卡、磁盘碟片、等)。控制器406包括多个用于交接驱动电路404的输入端和输出端。特别地，控制器406接收被测量的来自驱动电路404的关于电动机164和电池156的运转状态的传感器信号，并且依次地，基于传感器读数和特定的规则系统指示，输出控制信号至驱动电路404以控制电动机164的运转，这将在下文中更详细地描述。控制器406还配置为接收来自用户界面(例如，被联接至控制器406的控制组件107的开关、按钮、触摸屏等)的多个用户输入。
本公开提供了用于控制器械100或任何其他动力手术器械的设备和方法，所述动力手术器械包括但是不局限于线性动力吻合器、圆形或弓形动力吻合器、抓紧器、电手术密封镊子、旋转组织混合装置(rotary tissue blending device)等。特别地，器械100的驱动轴的转矩、RPM、位置、以及加速度可以与电动机特性(例如，电流消耗)相关联。由电动机164消耗的电流可以被用于探测机械极限，这是因为由电动机164消耗的电流随着电动机164的负载和速度而变化。因而，对电流消耗的变化量(例如，变化率)的分析允许区别不同类型的负载情形，例如，由组织施加的负载相比由机械阻挡(mechanical stop)施加的负载。
在电动机164正常操作的过程中，电流消耗通常不会超出预先确定的范围(例如，第一范围)。在夹紧和吻合过程中，通过组织施加到电动机164的负载在第二范围内变化，第二范围被第一范围包括。特别地，当电动机164遇到由于组织被砧座和钉仓组件306、308夹紧而引起的负载增加时，电流消耗增加并且在第二范围内持续第二时段(例如，电流消耗的增加的发生持续预先确定的时段)。如果电动机164遇到机械极限，电流消耗在相对短的时间内也会有对应的增加，这个电流消耗大于与组织夹紧相联系的电流消耗。特别地，由于机械阻挡导致的电流消耗在第三范围内持续第三时段，其中所述第三范围高于第二范围。相比之下，电动机164的启动比夹紧/紧固或机械阻挡中的任一个都消耗更多电流，并且增加的电流消耗的持续时间是如上所述的两个电流消耗中最短的。
在实施例中，可以通过比较电动机电流与预先确定的临界值来探测机械阻挡，这是因为当遇到机械阻挡时由电动机164消耗的电流通常远远高于正常操作电流。控制器406可以使用这个条件的满足来关闭电动机164。
当电动机164在正常操作过程中遇到高瞬时负载(例如，夹紧组织)时，这个方法呈现了一些挑战。与组织夹紧相联系的电流消耗可能达到临界值，因而导致控制器406过早地关闭电动机164。在实施例中，可以通过分析电动机164的正常电流消耗并构建正常电动机负载曲线来防止过早的关闭。然后，控制器406可以被设置程序从而依照那个曲线调整关闭临界值。对于有微小变动的负载曲线的电动机164，这个配置是适合的。然而，如果负载曲线偏离与正常使用相联系的电流消耗，大的变动可能产生误报。
电动机164和驱动机构的效率也会对计算电动机电流极限有影响。因为不同器械的机械效率可能不同，所以在组装过程中，每个器械需要单独校准。此外，机械效率随着器械的磨损而变化并且也可以影响软件的性能。
根据本公开的运算法则克服了使用单一-临界值或基于曲线的运算法则的问题。根据本公开的运算法则的优点是：所述运算法则利用电流随着时间的变化率而不是将电动机电流的幅度与预先确定的临界值相比较。与不同负载(例如，正常负载、重负载、机械阻挡、负载尖峰、等)相联系的电动机电流的变化率可以被分为不同范围，其中，每个范围与特定负载相联系。然后，所分的范围可以被用于识别电动机164的不同负载并滤除由电动机164的启动和停止引起的尖峰。因为机械负载的识别是基于电动机电流的变化率而非其幅度，所以与负载曲线的偏离不影响负载识别。此外，机械效率不影响基于电动机电流的变化率的负载识别。较低效率的器械消耗更多电流以获得相同的速度，然而，用于达到那些速度的斜率(例如，电流消耗的变化率)仍然与较高效率的系统的斜率相似。这消除了组装器械100的过程中对负载曲线(load profiling)和校准操作的需求。
根据本公开的运算法则的另一个优点是低计算费用。所述运算法则依赖计算电动机电流的变化率并且可以通过取得两个值之间的差来确定电动机电流的变化率，从而允许在8位微控制器内执行运算法则。
可以通过定时地对电流取样来测量电动机电流的变化。在实施例中，取样率可以是从大约每秒100到大约每秒10，000，在实施例中，从大约每秒500到大约每秒1，000。然后，控制器406可以使用样本计算电动机电流(例如，电流消耗)的变化。然后，控制器406可以使用电动机电流的变化确定器械100的操作情形并采取恰当行动。
本公开还提供了用于控制器械100的反馈系统和方法，所述反馈系统和方法基于外部操作情形，例如由于组织厚度和/或机械阻挡(例如，驱动梁365到达被限定在砧座板312和吻合钉钉仓305内的通道的远侧端)而使器械100遇到的发射困难。此外，本公开响应于外部操作情形(例如，特定故障)为器械100的不同用途提供模型，以得到内部系统反馈。控制器406使用来自传感器408a-n的传感器信息改变器械100的操作特性和/或向用户提示特定操作情形。在实施例中，控制器406控制(例如，限制)供给至电动机164的电流。
控制器406包括用于存储软件指令(例如，运算法则)的计算机可读内存406a和/或非临时媒介，所述软件指令用于基于所测量的电流消耗来探测器械100的机械极限。本文中所使用的，术语“机械极限”表示任何机电部件到达行进终点位置，这包括但不局限于，例如，驱动梁365到达被限定在砧座板312和吻合钉钉仓305内的通道的远侧端、机械安全锁定机构的致动防止轴364的行进、关节式运动连接件366到达末端执行器300的关节式运动极限、等等。
与一些负载情形(例如，组织夹紧或机械极限)的开始相联系的电动机电流的变化落入预先限定的范围内并持续某个时间。所述运算法则使用这些情形识别电动机164的操作特性并且对此作出响应。
参照图11，内存406a存储多个电流消耗值。内存406a包括具有值“I-V”的查询表格500或任何其他适合的数据结构。第一值“I”和第五值“V”限定第一范围，第一范围包含指示电动机164的正常(例如，承载)操作的稳定电流消耗信号。第二值“II”和第三值“III”限定第二范围，所述第二范围对应在组织夹紧的过程中与电动机164的电流消耗相联系的电流消耗；第四和第五值“IV”和“V”限定第三范围，所述第三范围对应与机械阻挡相联系的电流消耗。在实施例中，第一值“I”可以与第二值“II”相同。
控制器406还包括所关注的情形(condition-of-interest)的计数，其计数样本的数量，其中，在计数过程中，电动机电流的斜率(例如，变化率)在所期望的范围(例如，第一、第二或第三范围中的任一范围)内。控制器406还包括信号稳定计数，其计数斜率在第二范围内的样本的数量。控制器406使用表格500的值来判定所测量的电流消耗信号的变化率是否稳定。如果电流消耗样本的预先确定的数量在第一范围外，则信号被认为是不稳定；如果样本的预先确定的数量在第二范围内，则信号被认为是稳定的。
图12显示了根据本公开的用于判定电动机164是否遇到机械阻挡的方法。所述方法可以按照如上所述的被存储在控制器406中的软件指令(例如，运算法则)执行。首先，控制器406计算所测量的电动机电流(例如，电流消耗)的移动平均数。本文所使用的，术语“移动平均数”表示预先确定的子集样本的平均数，当每次获得新的样本时，更新所述平均数。根据如上所述的取样率，移动平均数可以包括从大约多个样本2到大约多个样本256，并且在实施例中，从大约多个样本16到大约多个样本64。控制器406存储第一移动平均数并计算随后的样本集的第二移动平均数。然后，控制器406确定移动平均数之间的差以计算样本间的变化。
如图12至图13所示，样本的移动平均数可以绘成图700、800、900，其中样本间的变化被描绘成图700、800、900的斜率。图700、800、900可以产生并输出在显示器上，从而允许用户观看电动机164的电流消耗。在实施例中，图700、800、900可以在内存406a中被存储为一系列的值，而无需将样本值再生成图。
所监视的电动机电流的变化还被限定为斜率，并且被用于区分由电动机164遇到的不同类型的负载。控制器406首先通过判定所计算的斜率/变化是否在第一范围外(例如，斜率大于第五值“V”或小于第一值“I”)来判定信号是否稳定。对于预先限定的数量的样本，如果斜率在第一范围外，控制器406通过将所关注的情形的计数和信号稳定计数设置为零、0来初始化或重新设置所关注的情形的计数和信号稳定计数。此外，控制器406还将信号状态设置为“不稳定”。
参照图14和图15，如图14所示的低于第一值“I”的样本以及如图15所示的高于第五值“V”的样本被滤除，这是因为上述样本代表电流消耗中的异常负尖峰和正尖峰。这些尖峰可以由电动机164的启动和停止引起并且可以导致在基于临界值的判定运算法则中的误报。
在判定斜率是否在第一范围外之后，控制器406判定斜率是否在第二范围(值II≤斜率≤值III)内。如果是，则稳定计数递增。在将信号状态变成“稳定”之前，控制器406核查稳定计数是否已经到达预先确定的临界值。这确保样本已经在第二范围内持续足够时段。任何偏离(例如，斜率在第一范围外)都重新设置所关注的情形的计数和信号稳定计数并将信号状态设置为“不稳定”，这在上文已描述。
参照图13至图15，与电动机电流样本的实际幅度无关，如果斜率在第二范围内，则信号被认为是稳定的。因而，通过本公开的运算法则以同样地方式处理落入图15的第二范围的样本的较高幅度和落入图13和图14的第二范围的样本的较低幅度，这是因为所关注的属性是电动机电流样本的斜率的变化率。
控制器406还判定样本是否在第三范围内。对于第三范围内的每个样本，当信号被认为是稳定的，所关注的情形的计数递增。每当样本降到低于第二值“II”时，所关注的情形的计数递减。所关注的情形的计数被用于识别机械阻挡，这将在下文更详细描述。如果所关注的情形的计数高于预先确定的临界值，则控制器406确定已经到达机械阻挡。参照图13，多个样本具有落入第三范围的斜率，这增加了所关注的情形的计数并且，当到达预先确定的计数时，触发如下标志：已经到达机械阻挡。一旦控制器406确定已经到达机械极限，可以终止至电动机164的电流供给从而防止器械100的进一步操作，和/或器械100可以发出警报。
图16显示了根据本公开的另一个实施例的用于确定电动机164是否遇到机械阻挡的方法。
如上所述，控制器406包括稳定计数和所关注的情形的计数。控制器406进一步包括正尖峰计数和负尖峰计数。这些计数保持电流(例如，斜率)超出第一范围的次数。更具体地，当电动机电流高于值“V”时，正尖峰计数递增；当电动机电流低于值“I”时，负尖峰计数递增。控制器406使用表格500的值判定所测量的电流消耗信号的变化率是否稳定。如果预先确定的数量的电流消耗样本在第一范围外(例如，正尖峰和负尖峰的数量高于预先确定的正尖峰和负尖峰临界值)，则信号被认为是不稳定的；如果预先确定的数量的样本在第二范围内，则信号被认为是稳定的。
如上所述，还可以按照被存储在控制器406内的软件指令(例如，运算法则)来执行图16的方法。首先，控制器406计算所测量的电动机电流(例如，电流消耗)的移动平均数。本文中所使用的，术语“移动平均数”表示预先确定的子集样本的平均数，当每次获得新的样本时，更新所述平均数。根据如上所述的取样率，移动平均数可以包括从大约2个样本到大约256个样本，而在实施例中，从大约16个样本到大约64个样本。控制器406存储第一移动平均数并计算随后的样本集的第二移动平均数。然后，控制器406确定移动平均数之间的差从而计算样本间的变化(例如，斜率)。
被监视的电动机电流的变化还被限定为斜率，并且用于区分电动机164遇到的不同类型的负载。首先，控制器406判定斜率是否大于第五值“V”并将之前的移动平均数更新成目前计算的移动平均数。如果斜率高于第五值“V”，则正尖峰计数递增而负尖峰计数递减。此外，控制器406查证正尖峰计数是否高于预先确定的正尖峰计数临界值。如果是，控制器406通过将所关注的情形计数和信号稳定计数设置为零、0来初始化或重新设置所关注的情形计数和信号稳定计数。此外，控制器406还将信号状态设置为“不稳定”。如果正尖峰计数低于预先确定的正尖峰计数临界值，则稳定计数递减。
在判定斜率是否高于第五值“V”之后，控制器406判定如果样本降到低于第二值“II”，则所关注的情形的计数递减。
控制器406还判定斜率是否小于第一值“I”并将之前的移动平均数更新成目前计算的移动平均数。如果斜率高于第一值“I”，则负尖峰计数递增而正尖峰计数递减。此外，控制器406查证负尖峰计数是否高于预先确定的负尖峰计数临界值。如果是，控制器406通过将所关注的情形计数和信号稳定计数设置为零、0来初始化或重新设置所关注的情形计数和信号稳定计数。此外，控制器406还将信号状态设置为“不稳定”。如果负尖峰计数低于预先确定的负尖峰计数临界值，则稳定计数递减。
参照图14和图15，如图14所示的低于第一值“I”的样本以及如图15所示的高于第五值“V”的样本被滤除，这是因为上述样本代表电流消耗中的异常负尖峰和正尖峰。这些尖峰可以由电动机164的启动和停止引起并且可以导致在基于临界值的判定运算法则中的误报。
控制器406还判定斜率是否在第二范围(例如，值“II”≤斜率≤值“III”)内。如果是，则稳定计数递增。在将信号状态变化成“稳定”之前，控制器406还核查稳定计数是否已经达到预先确定的临界值。这确保样本已经在第二范围持续足够时段。此外，控制器406通过将正尖峰计数和负尖峰计数设置为零、0来初始化或重新设置正尖峰和负尖峰计数。无论稳定计数低于还是高于预先确定的临界值，之前的移动平均数被更新成目前计算的移动平均数。任何偏离(例如，斜率在第一范围外)也重新设置所关注的情形的计数和信号稳定计数和并且将信号状态设置为“不稳定”，这已在上文描述。
控制器406还判定样本是否在第三范围内。对于第三范围内的每个样本，当信号被认为是稳定的，所关注的情形的计数增加。所关注的情形的计数被用于识别机械阻挡，这将在下文更详细描述。如果所关注的情形的计数高于预先确定的临界值，控制器406确定已经到达机械阻挡。参照图13，多个样本具有落入第三范围的斜率，这使得所关注的情形的计数递增，并且，当到达预先确定的计数时，触发如下标志：已经到达机械阻挡。一旦控制器406确定已经到达机械极限，可以终止至电动机164的电流供给从而防止器械100的进一步操作，和/或器械100可以发出警报。
除了关于装置性能的基本反馈，本公开还提供了用于动力装置的探测并了解其他外部因素(例如，早先很难探测的较厚组织)的方法。结果，可以实现极限的改进的中止(cutoff)和值，极大地改进了动力装置在使用时的安全性。使用如上所讨论的反馈机构，用户可以对当操作器械100时应该使用什么设置和技术做出明智的决定。这种明智可以涵盖选择不同的再装载器被线性吻合器发射、决定以不同的关节式运动角度发射、选择使用完全不同的手术技术。
应该理解的是，前述描述仅是本公开的例证性描述。本领域技术人员可以在不脱离本公开的情况下设计多种可选方案和改进。因此，本公开意图包括所有这种可选方案、改进和变动。介绍参照附图描述的实施例仅仅为了展示本公开的一些实施例。与上文和/或所附权利要求所描述的那些没有实质性不同的其他元件、步骤、方法和技术也意图被包括在本公开的范围内。

Claims (18)

1.一种手术器械，其包括：
手柄组件；
钳夹组件，其包括包含多个吻合钉的吻合钉钉仓和在发射时使所述多个吻合钉成形的砧座；
驱动组件，其至少部分地位于所述手柄内并且被连接至所述钳夹组件和锁定机构；
电动机，其被布置在所述手柄组件内并且被操作性地联接至所述驱动组件；以及
控制器，其被操作性地联接至所述电动机，所述控制器被配置为控制至所述电动机的电流的供给并且监视所述电动机的电流消耗，其中所述控制器被进一步配置为基于监视的电流消耗来探测所述手术器械的机械极限，所述机械极限表示所述手术器械中的任何机电部件到达行进终点位置；
所述控制器包括所关注的情形的计数，其在电动机电流的斜率在第三范围内期间计数样本的数量，所述第三范围对应与机械阻挡相联系的电流消耗，如果所关注的情形的计数高于预先确定的临界值，则所述控制器确定已经到达机械阻挡。
2.根据权利要求1所述的手术器械，其中所述控制器被进一步配置为通过判定所述电流消耗的变化率是否在电流消耗值的第一范围外来判定电动机电流何时不稳定。
3.根据权利要求2所述的手术器械，其中所述控制器被进一步配置为通过判定所述电流消耗的变化率是否在电流消耗值的第二范围内来判定电动机电流是否稳定，其中所述第二范围在所述第一范围内。
4.根据权利要求3所述的手术器械，其中所述控制器被进一步配置为存储在所述第二范围内的电流消耗样本的稳定计数。
5.根据权利要求4所述的手术器械，其中所述控制器判定当所述稳定计数高于预先确定的稳定临界值时电动机电流是否稳定。
6.根据权利要求5所述的手术器械，其中所述控制器被进一步配置为通过判定所述电动机电流是否稳定以及判定所述电流消耗的变化率是否在所述第三范围内来判定所述电动机何时已经达到所述机械极限。
7.根据权利要求6所述的手术器械，其中所述第三范围在所述第一范围内并且高于所述第二范围。
8.根据权利要求6所述的手术器械，其中所述控制器被进一步配置为存储在所述第三范围内的电流消耗样本的故障计数。
9.根据权利要求8所述的手术器械，其中所述控制器判定当所述故障计数高于预先确定的故障临界值时所述电动机是否已经达到所述机械极限。
10.一种手术器械，其包括：
手柄组件；
钳夹组件，其包括包含多个吻合钉的吻合钉钉仓和在发射时使所述多个吻合钉成形的砧座；
驱动组件，其至少部分位于所述手柄内并且被连接至所述钳夹组件和锁定机构；
电动机，其被布置在所述手柄组件内并且被操作性地联接至所述驱动组件；以及
控制器，其被操作性地联接至所述电动机，所述控制器被配置为基于监视的电流消耗来探测所述手术器械的机械极限，所述机械极限表示所述手术器械中的任何机电部件到达行进终点位置；
所述控制器包括所关注的情形的计数，其在电动机电流的斜率在第三范围内期间计数样本的数量，所述第三范围对应与机械阻挡相联系的电流消耗，如果所关注的情形的计数高于预先确定的临界值，则所述控制器确定已经到达机械阻挡。
11.根据权利要求10所述的手术器械，其中所述控制器被进一步配置为通过判定所述电流消耗的变化率是否在第一范围外来判定电动机电流是否不稳定。
12.根据权利要求11所述的手术器械，其中所述控制器被进一步配置为通过判定所述电流消耗的变化率的多个样本是否在第二范围内来判定电动机电流是否稳定。
13.根据权利要求12所述的手术器械，其中所述控制器被进一步配置为存储在所述第二范围内的电流消耗样本的稳定计数。
14.根据权利要求13所述的手术器械，其中所述控制器判定当所述稳定计数高于预先确定的稳定临界值时电动机电流是否稳定。
15.根据权利要求12所述的手术器械，其中所述控制器被进一步配置为通过判定所述电动机电流是否稳定以及判定所述电流消耗的变化率的多个样本是否在所述第三范围内来判定所述电动机是否达到机械极限。
16.根据权利要求15所述的手术器械，其中所述第二范围和第三范围在所述第一范围内并且所述第三范围高于所述第二范围。
17.根据权利要求15所述的手术器械，其中所述控制器被进一步配置为存储在所述第三范围内的电流消耗样本的故障计数。
18.根据权利要求17所述的手术器械，其中所述控制器判定当所述故障计数高于预先确定的故障临界值时所述电动机是否已经到达机械极限。
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