CN103767750B - 带有快速事后检测的手术器械 - Google Patents
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Abstract
本发明公开了一种带有快速事后检测的手术器械,所述器械包括:手柄组件;钳夹组件,其包括含有多个吻合钉的吻合钉钉仓以及砧座以在发射时使所述多个吻合钉成形;闭锁机构,其被配置为防止所述钳夹组件的再次使用;驱动组件,其至少部分地位于手柄内并且连接至所述钳夹组件;电机,其可操作地联接至所述驱动组件;以及控制器,其可操作地联接至所述电机,所述控制器被配置为控制电流至所述电机的供应并且监控所述电机的电流消耗,其中所述控制器被进一步配置为响应于电流消耗的下降而终止向所述电机的电流供应。
Description
技术领域
本公开涉及用于执行内窥镜外科手术操作的手术装置、设备和/或系统以及其使用方法。更具体地,本公开涉及这样的机电手持式手术装置、设备和/或系统:其被配置为与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,用来夹紧、切割和/或吻合组织。
背景技术
许多手术设备的生产商已经开发出具有用于操作和/或操纵机电手术设备的专用驱动系统的生产线。在许多情况下,机电手术设备包括能重复使用的手柄组件以及一次性的或单次使用的末端执行器。在使用之前末端执行器选择性地连接至手柄组件,然后在使用之后与手柄组件分离以便被处理掉或者在一些情况下被消毒以再次使用。
这些机电手术设备中的许多机电手术设备包括复杂的驱动部件,该驱动部件利用接受用户输入(例如,控制)以控制这些设备以及提供反馈给用户的各种各样的用户界面。为了防止无意的致动,存在各种闭锁机构。然而,现有的机构仅仅提供单一的安全检查。
不像纯粹的机械系统,动力系统具有即使在已经发生一些故障后仍检测这些故障并且对这些故障做出反应的能力。如果以快速方式完成这种检测,则能够实施正确的行动和紧急措施来减少和/或防止患者和/或用户受到伤害。相应地,存在对于具有能够检测此类故障的冗余安全机构的系统和装置的需求。
发明内容
本公开提供一种手术器械,包括:手柄组件;钳夹组件,其包括含有多个吻合钉的吻合钉钉仓以及砧座以在发射时使所述多个吻合钉成形;闭锁机构,其被配置为防止所述钳夹组件的再次使用;驱动组件,其至少部分地位于手柄内并且连接至所述钳夹组件和所述闭锁机构;一个电机或多个电机,其可操作地联接至所述驱动组件;以及控制器,其可操作地联接至所述电机,所述控制器被配置为控制电流至所述电机的供应并且监控所述电机的电流消耗,其中所述控制器被进一步配置为响应于所述电流消耗的下降或者其他触发度量(metrics)(RPM、加速度等等)的检测而终止向所述电机的电流供应。
根据本公开的一个方案,所述钳夹组件包括联接至所述闭锁机构的驱动梁,所述闭锁机构被配置为在所述驱动梁向远侧移动时在非锁定状态与锁定状态之间转换。
根据本公开的一个方案,所述电流消耗的下降对应于所述闭锁机构的故障从而在应当已经触发所述闭锁机构后适当地阻止设备使用。根据本公开的一个方案,所述闭锁机构包括能在非锁定位置与锁定位置之间枢转的锁定构件。
根据本公开的一个方案,所述钳夹组件进一步包括壳体,所述壳体限定了安装在其中的凸起,所述凸起被配置为在所述驱动梁退回时与所述锁定构件接合。
本公开还提供一种手术器械,包括:手柄组件;一次性的末端执行器,其能拆卸地联接到所述手柄组件,所述一次性的末端执行器包括钳夹组件,所述钳夹组件包括含有多个吻合钉的吻合钉钉仓和砧座以在发射时使所述多个吻合钉成形;以及驱动组件,其至少部分地位于手柄内并且连接至所述钳夹组件,所述驱动组件包括闭锁机构。所述手术器械还包括:电机(或多个电机),其可操作地联接至所述驱动组件;驱动电路,其联接至所述电机(或多个电机)并且被配置为测量所述电机的电流消耗(以及其他度量);以及控制器,其可操作地联接至所述电机,所述控制器被配置为响应于表示所述闭锁机构故障的电流消耗的下降而终止向所述电机的电流供应。
根据本公开的一个方案,所述控制器进一步被配置为响应于所述电流消耗的下降而在存储器中存储故障状态。
根据本公开的一个方案,在从所述手柄组件移除所述一次性的末端执行器之后,所述故障状态被清除。
根据本公开的一个方案,所述控制器被配置为基于电流消耗的变化率而检测所述电流消耗的下降。
根据本公开的一个方案,所述钳夹组件包括联接至所述闭锁机构的驱动梁。
根据本公开的一个方案,所述闭锁机构被配置为在所述驱动梁向远侧移动时在非锁定状态与锁定状态之间转换。
根据本公开的一个方案,所述电流消耗的下降对应于所述闭锁机构的故障从而在所述驱动梁退回时转换至所述锁定状态。
根据本公开的一个方案,所述闭锁机构包括能在非锁定位置与锁定位置之间枢转的锁定构件。
根据本公开的一个方案,所述钳夹组件进一步包括壳体,所述壳体限定了安装在其中的凸起,所述凸起被配置为在所述驱动梁退回时与所述锁定构件接合。
根据本公开的一个方案,所述手术器械进一步包括联接至所述控制器的控制组件,其中所述控制器响应于所述电流消耗的下降而忽视用户输入。
本公开还提供一种用于控制手术器械的方法。该方法包括以下步骤:致动可操作地联接至一次性的末端执行器的电机。所述末端执行器包括:驱动梁,其联接至钳夹组件,所述钳夹组件包括含有多个吻合钉的吻合钉钉仓以及砧座以在发射时使所述多个吻合钉成形;以及闭锁机构,其联接至所述驱动梁并且被配置为在所述驱动梁退回时从非锁定状态转换至锁定状态。所述方法进一步包括:测量所述电机的电流消耗;并且响应于表示所述闭锁机构故障的电流消耗的下降而终止向所述电机的电流供应。
根据本公开的一个方案,所述方法进一步包括响应于所述电流消耗的下降而在存储器中存储故障状态的步骤。
根据本公开的一个方案,所述方法进一步包括如下步骤:在从手柄组件移除所述一次性的末端执行器之后,清除所述故障状态。
附图说明
这里参照附图描述了本公开的各种实施例,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立体拆装图;
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的手术器械的立体分解图;
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的手术器械的部分拆装的俯视图;
图6是根据本公开的图1的手术器械的主视立体图,其中接合器与手术器械分开;
图7是根据本公开的沿图2的7-7截取的图1的手术器械的侧剖视图;
图8是根据本公开的沿图2的8-8截取的图1的手术器械的顶部剖视图;
图9是根据本公开的图1的末端执行器的立体分解图;
图10A根据本公开的锁定构件的俯视图;
图10B是根据本公开的图10A的锁定构件的立体图;
图11是根据本公开的图1的手术器械的示意图;
图12是根据本公开用于控制图1的手术吻合器的方法的流程图;
图13至图15是根据本公开的方法所控制的应用至手术吻合器的电机的机械阻力、旋转速度以及电流的曲线图;以及
图16是由本公开的方法所控制的手术吻合器的电机的电流消耗的曲线图。
具体实施方式
依照本公开的实施例,手术系统一般表示为10,并且是电动的手持式机电器械的形式,其被配置用于将多个不同的末端执行器选择性地附接于此,所述末端执行器均被配置为通过电动的手持式机电手术器械来进行致动和操纵。
如图1所示,手术器械100被配置为选择性地连接接合器200,并且依次地,接合器200被配置为选择性地连接末端执行器或单次使用的装载单元或重复装载器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包括下壳体部104、中壳体部106以及上壳体部108,中壳体部106从下壳体部104延伸出和/或被支承在下壳体部104上,上壳体部108从中壳体部106延伸出和/或被支承在中壳体部106上。中壳体部106和上壳体部108被分成远侧半部110a和近侧半部110b,其中,远侧半部110a与下壳体部104整体形成且从其延伸出,近侧半部110b能够通过多个紧固件与远侧半部110a相连接。当联结时,远侧半部110a与近侧半部110b限定了手柄壳体102,在手柄壳体102内有空腔102a,电路板150和驱动机构160位于空腔102a中。
如图2和图3中所示,远侧半部110a和近侧半部110b沿着横穿上壳体部108的纵向轴线“X”的平面被划分。手柄壳体102包括垫圈112,垫圈112完全绕远侧半部110a和/或近侧半部110b的边缘延伸并且被置于远侧半部110a和近侧半部110b之间。垫圈112对远侧半部110a和近侧半部110b的周边进行密封。垫圈112起到在远侧半部110a与近侧半部110b之间建立气密密封的作用,使得电路板150和驱动机构160被保护免受消毒和/或清洁程序的损坏。
以此方式,手柄壳体102的空腔102a沿着远侧半部110a与近侧半部110b的周边被密封,但是被配置为使得手柄壳体102中的电路板150和驱动机构160能够更容易、更有效率的组装。
手柄壳体102的中壳体部106提供了电路板150位于其中的壳体。如以下将另外更详细地阐述的,电路板150被配置为控制手术器械100的各种操作。
手术器械100的下壳体部104限定了形成在其上表面中的孔(未显示),该孔位于中壳体部106的下方或位于中壳体部106内。下壳体部104的孔提供了供导线152穿过的通路,以将位于下壳体部104中的电力部件(如图4所示的电池156,如图3所示的电路板154等等)与位于中壳体部106和/或上壳体部108中的电力部件(电路板150、驱动机构160等等)互相电连接。
手柄壳体102包括布置在下壳体部104的孔(未显示)内的垫圈103,从而在允许导线152通过孔的同时填塞或密封下壳体部104的孔。垫圈103起到在下壳体部104与中壳体部106之间建立气密密封的作用,使得电路板150和驱动机构160被保护免受消毒和/或清洁程序的损坏。
如所示,手柄壳体102的下壳体部104提供了可再充电电池156可拆卸地位于其中的壳体。电池156被配置为向手术器械100的任何电力部件供应电力。下壳体部104限定了空腔(未显示),电池156被插入该空腔中。下壳体部104包括能枢转地连接至下壳体部104的盖105,用于闭合下壳体部104的空腔并且将电池156保持在其中。
参照图3和图5,上壳体部108的远侧半部110a限定了鼻部或连接部108a。鼻锥114支承在上壳体部108的鼻部108a上。鼻锥114由透明材料制备。照明构件116布置在鼻锥114内使得透过鼻锥114可以看得见照明构件116。照明构件116可以是发光二极管印刷电路板(LED PCB)。照明构件116被配置为照射多个颜色,其中特定的颜色图案与独特的个别事件相关。
手柄壳体102的上壳体部108提供了驱动机构160位于其中的壳体。如图5所示,驱动机构160被配置为驱动轴和/或齿轮部件以便于执行手术器械100的各种操作。特别地,驱动机构160被配置为驱动轴和/或齿轮部件,以便于相对于末端执行器300的近侧主体部302选择性地移动末端执行器300的工具组件(参见图1和图9)、使末端执行器300相对于手柄壳体102绕纵向轴线“X“(参见图2)旋转、使砧座组件306相对于末端执行器300的钉仓组件308移动和/或发射末端执行器300的钉仓组件308内的吻合和切割钉仓。
驱动机构160包括选择式齿轮箱组件162,选择式齿轮箱组件162相对于接合器200紧接地靠近。与选择式齿轮箱组件162邻近的是具有第一电机164的功能选择模块163,功能选择模块163起到的作用是选择性地移动选择式齿轮箱组件162内的齿轮元件以与具有第二电机166的输入驱动部件165相接合。
如图1至图4所示,并且如上所述,上壳体部108的远侧半部110a限定了连接部108a,连接部108a被配置为接受接合器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具有圆柱形凹部108b,当接合器200与手术器械100配接时,圆柱形凹部108b接纳接合器200的驱动联接组件210。连接部108a容纳三个能旋转的驱动连接器118、120、122。
当接合器200与手术器械100配接时,如图6所示,手术器械100的能旋转的驱动连接器118、120、122中的每一个驱动连接器与接合器200的对应的能旋转的连接器套管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之间的交接都被锁定,以使得手术器械100的驱动连接器118、120、122中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的相应旋转。
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的配接允许旋转力经由三个相应的连接器交接中的每一个而独立地传送。手术器械100的驱动连接器118、120、122被配置为通过驱动机构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中哪一个或者哪几个。
由于手术器械100的驱动连接器118、120、122中的每一个驱动连接器均与接合器200的相应的连接器套管218、220、222具有锁定交接和/或基本上非旋转的交接,所以当接合器200联接到手术器械100上时,旋转力会选择性地从手术器械100的驱动机构160转移至接合器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。如下面将更详细地讨论的,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于末端执行器300的工具组件304的选择性的且独立的打开和闭合,以及对应于末端执行器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于末端执行器300的工具组件304横向于纵向轴线“X”(参照图2)的选择性的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于末端执行器300相对于手术器械100的手柄壳体102绕纵向轴线“X”(参照图2)的选择性的且独立的旋转。
如上所述并且如图5和图8中所示,驱动机构160包括选择式齿轮箱组件162和功能选择模块163,其中功能选择模块163靠近选择式齿轮箱组件162而定位,其起到的作用是选择性地移动选择式变速器组件162内的齿轮元件以与第二电机166相接合。这样,驱动机构160就可以在给定的时间选择性地驱动手术器械100的驱动连接器118、120、122中的一个驱动连接器。
如图1至图3所示,手柄壳体102在中壳体部106的远侧表面或侧部上支承控制组件107。控制组件107是全功能的机械子组件,其能够在联接到器械100之前与器械100的其余部分分开组装和测试。
控制组件107以与中壳体部106协作的方式支承壳体107a内的一对手指致动的控制按钮124、126和一对摇杆装置128、130。控制按钮124、控制按钮126分别联接至延伸轴125、延伸轴127。特别地,控制组件107限定了用于滑动地接纳延伸轴125的上孔124a和用于滑动地接纳延伸轴127的下孔126a。
控制组件107和其部件(例如,控制按钮124、控制按钮126以及摇杆装置128和摇杆装置130)可以由低摩擦、自润滑的、润滑塑料或材料或覆盖运动部件的涂层形成,以减小致动力、主要部件损耗、消除摩损、平滑一致的致动、改进部件和组件可靠性以及用于更紧密装配的减小的间隙以及感觉一致性。如下面进一步详细描述的,这包括塑料材料在衬套、摇杆轴颈、柱塞套、弹簧套、保持环以及滑动器部件中的使用。将部件模制在塑料中还提供了具有全部这些性能特征的网形状或丝网形状的部件。塑料部件消除了在电解条件(诸如高压消毒、蒸汽消毒以及清洁)下的腐蚀和双金属阳极反应。具有润滑塑料和材料的压配合当与类似的金属部件相比较时,还以部件上的最小变形或功能损失(functional penalties)消除了间隙。
用于形成控制组件107的部件的合适材料包括但不限于聚胺类、聚苯硫醚类、聚邻苯二甲酰胺类、聚苯砜类、聚醚酮类、聚四氟乙烯类以及其组合。这些部件可以在存在或不存在润滑剂的情况下使用并且还可以包括用于减少损耗和摩擦力的添加剂。
为了对手术器械100的构造和操作进行详细讨论,可以参照共同拥有的申请号为13/331,047的美国专利申请,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包括挠性驱动梁364,挠性驱动梁364具有近侧接合部368和被固接至动态(dynamic)夹紧构件365的远侧端。接合部368包括限定了肩部370的梯状部。接合部368的近侧端包括直径上对置的向内延伸的指状件372。指状件372接合中空的驱动构件374以将驱动构件374牢固地固接至梁364的近侧端。驱动构件374限定了近侧孔口376a,当末端执行器300附接至接合器200的远侧联接器230时,近侧孔口376a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,夹紧构件365的上梁365a在砧座板312与砧座盖310之间限定的通道内移动,并且下梁365b移动到托架316的外部表面上以闭合工具组件304并且从其中发射吻合钉。
末端执行器300的近侧主体部302包括护套或外管301,其围住上壳体部301a和下壳体部301b。壳体部301a和壳体部301b围住关节式运动连杆366,关节式运动连杆366具有从末端执行器300的近侧端延伸出的钩状近侧端366a。当末端执行器300被固接至接合器200的远侧壳体232时,关节式运动连杆366的钩状近侧端366a与接合器200的联接钩(未显示)接合。如上所述,当接合器200的驱动杆258被推进或退回时,末端执行器300的关节式运动连杆366在末端执行器300内被推进或退回,以使得工具组件304相对于近侧主体部302的远侧端枢转。
如上面图9中所示的,工具组件304的钉仓组件308包括能够支承在托架316中的吻合钉钉仓305。该钉仓能够永久地安装在末端执行器300中或者被布置成便于能拆卸以及更换。吻合钉钉仓305限定了中央纵向狭槽305a以及被定位在纵向狭槽305a的每一侧上的三个线性排的吻合钉保持狭槽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。在器械100的操作期间,驱动组件360与致动滑板邻接并且推动致动滑板通过钉仓305。随着致动滑板移动通过钉仓305,致动滑板的凸轮楔顺序地与吻合钉推动器309接合以在吻合钉保持狭槽305b内竖直地移动吻合钉推动器309并且顺序地从其中排出吻合钉307用于抵靠砧座板312成形。
中空的驱动构件374包括闭锁机构373,闭锁机构373防止先前发射的末端执行器300的发射。闭锁机构373包括锁定构件371,锁定构件371经由销377枢转地联接在远侧孔口376b内,使得锁定构件371相对于驱动构件374绕销377能枢转。
参照图10A和图10B,锁定构件371限定了形成在细长滑道381与细长滑道383之间的通道379。连结板385联结滑道381和滑道383的上表面的一部分。连结板385被配置且定尺寸为装配在驱动构件374的孔口376b内。水平凸缘389和水平凸缘391分别从滑道381和滑道383延伸出。如图9最清楚显示的,弹簧393布置在驱动构件374内并且与水平凸缘389和/或水平凸缘391接合以使锁定构件371向下偏置。
在操作中,锁定构件371一开始布置在壳体部301a和壳体部301b的近侧端处的其预先发射位置,其中水平凸缘389和水平凸缘391静置在形成于壳体部301b的侧壁中的凸起303a和凸起303b的顶部上。在此位置,锁定构件371被支撑并且在凸起303a和凸起303b的远侧,不与形成在壳体部310b的底面中的凸起303c对齐,并且连结板385与限定在驱动梁364中的肩部370纵向并置。这种构造允许砧座306被打开并且重新定位在待吻合的组织上直到外科医生满意此位置,无需致动锁定构件371来禁用一次性的末端执行器300。
在驱动梁364通过驱动管246向远侧移动时,锁定构件371滑离(rides off)凸起303a和凸起303b并且通过弹簧393在凸起303c的远侧被偏置成与壳体部301b接合。在装置发射的整个过程中,锁定构件371保持这种构造。
在驱动梁364退回时,在至少一部分发射之后,锁定构件371在凸起303a、凸起303b下方穿过并且滑过壳体部301b的凸起303c上方直到锁定构件371的最远侧部分靠近凸起303c。弹簧393将锁定构件371偏置成与凸起303c并列对齐,从而有效地禁用一次性的末端执行器。如果尝试再次致动装载有现有末端执行器300的装置,则锁定构件371将与壳体部301b的凸起303c邻接并且将抑制驱动梁364向远侧移动。
末端执行器300还可以包括一个以上机械的闭锁机构,诸如在共同拥有的第5,071,052号、第5,397,046号、第5413,267号、第5,415,335号、第5,715,988号、第5,718,359号、第6,109,500号美国专利中描述的那些,所有这些专利的全部内容通过引用合并于此。
在图11中示出了器械100的另一个实施例。器械100包括电机164。电机164可以是被配置为致动一个以上驱动件(例如图6的能旋转驱动连接器118、120、122)的任何电动机。电机164被联接至电池156,电池156可以是直流(DC)电池(例如,可再充电的基于铅、基于镍、基于锂离子的电池等等)、AC/DC变压器或者适合为电机164提供电能的任何其他电源。
电池156和电机164联接至布置在电路板154上的电机驱动电路404,电机驱动电路404控制电机164的操作,包括电能从电池156流至电机164。驱动电路404包括多个传感器408a,408b,…408n,多个传感器408a,408b,…408n被配置为测量电机164和电池156的工作状态。传感器408a-n可以包括电压传感器、电流传感器、温度传感器、压力传感器、遥测传感器、光传感器以及其组合。传感器408a-408n可以测量由电池156供应的电能的电压、电流以及其他电特性。传感器408a-408n还可以测量电机164的作为每分钟转数(RPM)的旋转速度、转矩、温度、电流消耗以及其他工作特性。可以通过测量电机164的旋转来确定RPM。可以通过使用布置在轴中或靠近轴布置的各种线性传感器来确定各个驱动轴(例如图6中的能旋转驱动连接器118、120、122)的位置或者从RPM测量结果中推导各个驱动轴(例如图6中的能旋转驱动连接器118、120、122)的位置。在实施例中,可以在恒定RPM下基于电机164的调整后的电流消耗来计算转矩。在另一实施例中,驱动电路404和/或控制器406可以测量时间并且处理上述值以作为其功能,包括积分和/或微分,例如以确定测量值的变化率等等。
驱动电路404还被联接至控制器406,控制器406可以是适于根据下文进一步详细描述的一套指令而执行计算和/或运算的任何适当的逻辑控制电路。控制器406可以包括中央处理单元,其可操作地连接至存储器,所述存储器可以包括暂时类型的存储器(例如,RAM)和/或非暂时类型的存储器(例如,闪存介质、磁盘介质等等)。控制器406包括用于与驱动电路404接口的多个输入和输出。特别地,控制器406从驱动电路404接收关于电机164和电池156的工作状态的所测量的传感器信号,并且反过来基于传感器读数和具体的算法指令而输出控制信号至驱动电路404以控制电机164的操作,这将在下文更详细地讨论。控制器406还被配置为从用户界面(例如,联接至控制器406的控制组件107的开关、按钮、触摸屏等等)接受多个用户输入。可以提供可移除的存储器卡或芯片,或者能够无线地下载数据。
本公开提供用于控制器械100或任何其他动力的手术器械的装置和方法,包括但不限于线性动力吻合器、环形或弓形的动力吻合器、抓取器、电外科手术密封钳子、旋转的组织混合设备等等。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机性质(例如,电流消耗)相关联。本公开还提供了用于基于外部操作条件(诸如由于组织厚度而使器械100遇到的发射困难)来控制器械100的反馈系统和方法。此外,本公开提供了响应于外部操作条件(例如,具体的故障)而对器械100的不同用法进行建模以便得到内部系统反馈。
控制器406使用来自传感器408a-n的传感器信息以改变器械100的操作性质和/或通知用户具体的操作条件。在实施例中,控制器406控制(例如,限制)供应至电机164的电流以便控制器械100的操作。
图12示出了根据本公开的用于控制器械100尤其是电机164的方法。所述方法可以实施为存储在控制器406中的软件指令(例如,算法)。在步骤452中,控制器406将待供应至电机164的电流设置成第一电流限制值“A”。这可以手动地或自动地完成,例如,从存储在存储器中的查询表预加载。控制器406还分别存储与第一电流限制值“A”相关联的第一上RPM限制值“X”和第一下RPM限制值“Y”。在步骤454中,控制器406通过向电机164发信号来开始器械100的操作从而旋转驱动螺钉74以夹持组织和/或驱动吻合钉通过组织。控制器406向驱动电路404发信号以便以上RPM限制值“X”驱动电机164。
在步骤456中,驱动电路404继续监控电机164的RPM并且提供测量信号至控制器406。控制器406将测量的RPM信号与下RPM限制值“Y”进行比较。如果值在下RPM限制值“Y”之上,则驱动电路404继续以上RPM限制值“X”驱动电机164。如果值在下RPM限制值“Y”之下,这表示电机164在发射期间已经遇到阻力,例如,更厚的组织、梗阻等等,则在步骤458中,控制器406将供应至电机164的电流设置成第二电流限制值“B”。
控制器406还为第二电流限制值“B”分别存储第二上RPM限制值“Z”和第二下RPM限制值“W”。因为更大的电流增加了电机164的转矩和RPM以便克服在吻合期间遇到的阻力,所以第二电流限制值“B”大于第一电流限制值“A”。在步骤460中,控制器406以上RPM限制值“Z”驱动电机164。
在步骤462中,驱动电路404继续监控电机164的RPM并且提供测量信号至控制器406。控制器406将测量的RPM信号与下RPM限制值“W”进行比较。如果值在下RPM限制值“W”之上,则驱动电路404继续以上RPM限制值“Z”驱动电机164。如果值在下RPM限制值“W”之下,这表示电机164在发射期间已经遇到进一步的阻力,则在步骤464中,控制器406终止供应至电机164的电流。第二电流限制值“B”充当可以操作电机164的最后电流值。
在实施例中,可以设置用于电机164和驱动电路404的多个电流限制值以允许控制器406基于遇到的阻力在多个电流限制值之间切换。电流限制值中的每个电流限制值还可以与控制器406切换至相邻的电流限制值所在的相应上RPM限制值和下RPM限制值相关联。在进一步的实施例中,如果所遇到的阻力已经降低,所述方法则可以切换回较小的电流限制值,这可以基于较小的电流消耗和/或较大的RPM限制值来检测。
图13至图15图示出电机164在各种操作情况期间的性能曲线图。图13至图15示出了作为时间的函数的旋转速度、转矩以及电流的曲线图。在图13至图15中,水平轴501代表被表示为无单位刻度的参考时间,左纵轴503代表电机164上的机械阻力(例如转矩)和电机164的RPM,其是不成比例的,并且右纵轴505代表供应至电机164的电流。左纵轴503分别包括第一上RPM限制值“X”和第一下RPM限制值“Y”以及第二上RPM限制值“Z”和第二下RPM限制值“W”。右纵轴505包括第一电流限制值“A”和第二电流限制值“B”。
图13至图15图示出图12的方法的各种实施例。图13示出了RPM曲线500、转矩曲线502以及电流曲线504。随着发射过程开始,电机164上的机械负载保持较低并且电机164的RPM在第一上RPM限制值“X”处保持不变,如曲线500所示。因为RPM没有降到下RPM限制值“Y”之下,所以该方法不会进展到步骤456之后。因此,如由曲线504所表示的,在发射过程期间未达到第一电流限制值“A”,并且如曲线502所示,转矩也保持不变。
图14示出了RPM曲线600、转矩曲线602以及电流曲线604。随着发射过程开始,如图13中所图示的机械负载最初是不变的,但是在图14的位置606处图示出电机164上增加的应力(strain)。随着负载增加,电机164需要更多的电流来将RPM维持在上RPM限制值“X”处。控制器406向驱动电路404发出信号以将电流限制在电流限制值“A”之下。
如曲线600所表示的,机械负载的增加导致电机164的RPM下降到下RPM限制值“Y”之下并且在位置608处电流超过第一电流限制值“A”。参照图12的流程图,在方法的步骤456处,如上所述,检测到电机164的RPM的下降并且在步骤458和步骤460中设置更高的电流限制值“B”以及上RPM限制值“Z”和下RPM限制值“W”。在位置610处,一旦设置更高的电流限制值“B”,电机164在上RPM限制值“Z”处继续其操作直到完成发射过程。
图15示出了RPM曲线700、转矩曲线702以及电流曲线704。随着发射过程开始,如图13和图14中所图示,机械负载最初是不变的,但是在位置706处图示出电机164上增加的应力。随着负载增加,电机164需要更多的电流来将RPM维持在上RPM限制值“X”处。控制器406向驱动电路404发出信号以将电流限制在电流限制值“A”之下。
如曲线700所表示的,机械负载的增加导致电机164的RPM在位置708处下降到下RPM限制值“Y”之下。参照图12的流程图,在方法的步骤456处,如上所述,检测到电机164的RPM的下降并且在步骤458和步骤460中设置更高的电流限制值“B”与上RPM限制值“Z”和下RPM限制值“W”。
在位置710处,一旦设置更高的电流限制值“B”,电机164响应于更高的机械负载而在上RPM限制值“Z”处继续其操作直到位置712,在位置712处电机164遇到额外的阻力或应力。随着负载增加,电机164需要更多的电流来将RPM维持在上RPM限制值“Z”处。控制器406向驱动电路404发出信号以将电流限制在电流限制值“B”之下。
如曲线700所表示的,机械负载的进一步增加导致电机164的RPM下降到下RPM限制值“W”之下并且在位置712处电流超过第二电流限制值“B”。参照图12的流程图,在方法的步骤462处,检测到电机164的RPM的二次下降并且控制器406向驱动电路404发出信号以在位置714处关闭电机164,如图15所示。
本公开提供了若干优势给设备性能、安全以及终端用户体验。器械100在操作期间为用户提供了直观的反馈方法,包括视觉的和听觉的反馈。特别地,当器械100遇到增加的机械负载时,本公开降低电机164的RPM或关闭电机164。该基本的性能反馈实现了常规动力设备不能解决的更大的用户需要。其实施允许用户更有效地使用动力器械。
在这里公开的任何实施例中,重复装载器300和接合器200能够与通过空气压力、交流电(诸如墙壁插座)、发电机或其他装置提供动力的器械100一起使用。在任何实施例中,器械100和接合器200可以利用两个驱动轴而不是三个驱动轴,或者多于三个驱动轴。
在这里公开的任何实施例中,控制器可以存储关于电流、RPM、力、时间、压力或关于系统使用的其他数据的信息。在任何实施例中,可以在系统中的重复装载器300或其他地方设置传感器。在这里公开的任何实施例中,存储器可以在指令下或自动地无线转移数据至另一个存储设备,或者能够设置可移除的芯片或卡来存储此类数据。
选择性地且智能地改变操作速度的这种算法的使用可以提供进一步的益处。在实施例中,器械100可以在极端条件下减小发射速度。这种减慢造成花费更长的时间完成发射。其结果是,提供了组织能够压缩并且流体能够扩散的额外时间。与用固定的发射速度吻合器所能发射到的组织相比,这允许重复装载器被成功地发射到更大的组织块上。在具体情况下RPM和电流限制值的具体变化可以减少设备老化,改善吻合钉成形,使内部温度降低,消除工作周期的需要,增加设备功能寿命以及可靠性。
在任何手术器械的使用期间,一个以上的安全机构诸如闭锁机构373可能出故障。控制器404基于由图6的能旋转的驱动连接器118、120、122行进的距离来确定末端执行器300的发射进展。发射状态的完成和/或故障被存储在存储器中并且可以使用各种状态指示(例如,LED)来告知用户。尽管这里描述了闭锁机构373的具体故障,但是可以设想的是,可以使用电机164的度量(metrics)相关性来提供机械安全闭锁的另外的安全检查。
图16图示出在闭锁机构373的机械故障期间电机164的性能曲线。在图16中,水平轴801代表以秒表示的参考时间,左纵轴803代表电机164的电流消耗。图16还示出了电流消耗曲线800和处理后的电流消耗曲线802。随着发射过程开始,如曲线800所示,在位置804之前,随着驱动梁364被推进,电机164上的机械负载略微地增加。电流消耗然后急剧地下降直到位置806,这表示闭锁机构373的故障(例如,锁定构件371未接合凸起303c)。如图所示出,在位置808处,电流的供应被完全切断,电流几乎瞬时下降到零安培(A)。
曲线802示出了表示电流消耗的处理后曲线。特别地,可以由驱动电路404和/或控制器406来处理曲线800的电流消耗以输出曲线802。曲线802可以通过电机164(例如,曲线800)和电机164的一个以上度量(包括但不限于时间、旋转速度、转矩、温度、各个驱动轴的位置以及其组合)而生成作为电流消耗的函数。
曲线802跟踪最初的电流消耗直到位置804。位置804与位置806之间的第一次下降也反应在处理后的曲线802中,其表示闭锁机构373的故障。然后电流消耗急剧地下降直到位置808。如图所示,在位置808处电流的供应也完全被切断,在位置810处,在曲线802中几乎是瞬时下降。
驱动电路404和/或控制器406可以通过监控电流消耗的变化率而检测电流消耗的下降。响应于闭锁机构373故障的检测,驱动电路404和/或控制器406停止将电流施加至电机164,从而终止发射过程。此外,驱动电路404和/或控制器406可以闭锁器械100的操作直到末端执行器300被移除。在闭锁期间,器械100可以变得完全或部分地不响应用户输入(例如,控制组件107的致动)并且可以经由各种状态指示(例如,LED)向用户通知故障状态。在实施例中,驱动电路404和/或控制器406可以在存储器中存储故障指示。故障指示可以驻留在存储器中直到故障被清除(例如,通过更换末端执行器300),从而防止末端执行器300的再次使用。
检测闭锁机构373的故障的所公开的闭锁机构373和驱动电路404和/或控制器406的组合允许防止末端执行器300的再次使用。闭锁机构373的故障(例如,由于擅自拆卸)可以允许先前使用的末端执行器300的未授权的再次装载。即使当不存在闭锁机构373或者闭锁机构373有其他功能障碍时,由驱动电路404和/或控制器406监控的电流下降仍允许防止先前使用的末端执行器300的再次使用。驱动电路404和/或控制器406被配置为当电机164的操作指示故障的闭锁机构373时仅触发故障条件。换言之,如果闭锁机构373适当地起作用,则电机164的电流消耗在位置804处不下降,从而不触发上述的电子闭锁。在这里公开的任何实施例中,手术系统可以包括在各个位置的多于一个的闭锁,并且一个以上的闭锁可以采取各种形式。
除了关于设备性能的基本反馈之外,本公开还提供了一种用于动力设备的方法以检测并且识别先前难以检测的其他外部因素,例如,更厚的组织。其结果是,可以实施改进的切断和限制值,这极大地改善使用中的动力设备的安全性。使用上述的反馈机构,用户可以作出关于当操作器械100时应当使用什么设置和技术的智能决定。这种智能可以包括的范围从选择不同的重复装载器来用线性吻合器发射、确定以不同的关节式运动角度发射到选择使用完全不同的手术技术。
应当理解的是,上述说明仅仅是本公开的示意。本领域的技术人员可以设想各种替代和修改而不背离本公开。因此,本公开旨在包括全部此类替代、修改和变型。参照附图描述的实施例被提供仅用于阐释本公开的特定示例。与上面描述的和/或随附权利要求书描述的那些非实质上不同的其他元件、步骤、方法和技术也旨在在本公开的范围内。
Claims (15)
1.一种手术器械,包括:
手柄组件;
钳夹组件,其包括含有多个吻合钉的吻合钉钉仓以及砧座以在发射时使所述多个吻合钉成形;
闭锁机构,其被配置为防止所述钳夹组件的再次使用;
驱动组件,其至少部分地位于手柄内并且连接至所述钳夹组件和所述闭锁机构;
电机,其可操作地联接至所述驱动组件;以及
控制器,其可操作地联接至所述电机,所述控制器被配置为控制电流至所述电机的供应并且监控所述电机的电流消耗,其中所述控制器进一步被配置为响应于表示所述闭锁机构故障的电流消耗的下降而终止向所述电机的电流供应。
2.根据权利要求1所述的手术器械,其中所述钳夹组件包括联接至所述闭锁机构的驱动梁,所述闭锁机构被配置为在所述驱动梁向远侧移动时在非锁定状态与锁定状态之间转换。
3.根据权利要求2所述的手术器械,其中所述电流消耗的下降对应于所述闭锁机构的故障从而在所述闭锁机构被触发后适当地阻止设备使用。
4.根据权利要求3所述的手术器械,其中所述闭锁机构包括能在非锁定位置与锁定位置之间枢转的锁定构件。
5.根据权利要求4所述的手术器械,其中钳夹组件进一步包括壳体,该壳体限定了安装在其中的凸起,所述凸起被配置为在所述驱动梁退回时与所述锁定构件接合。
6.一种手术器械,包括:
手柄组件;
一次性的末端执行器,其能拆卸地联接到所述手柄组件,所述一次性的末端执行器包括钳夹组件,所述钳夹组件包括含有多个吻合钉的吻合钉钉仓和砧座以在发射时使所述多个吻合钉成形;
驱动组件,其至少部分地位于手柄内并且连接至所述钳夹组件,所述驱动组件包括闭锁机构;
电机,其可操作地联接至所述驱动组件;
驱动电路,其联接至所述电机并且被配置为测量所述电机的电流消耗;以及
控制器,其可操作地联接至所述电机,所述控制器被配置为响应于表示所述闭锁机构故障的电流消耗的下降而终止向所述电机的电流供应。
7.根据权利要求6所述的手术器械,其中所述控制器进一步被配置为响应于所述电流消耗的下降而在存储器中存储故障状态。
8.根据权利要求7所述的手术器械,其中在从所述手柄组件移除所述一次性的末端执行器之后,所述故障状态被清除。
9.根据权利要求6所述的手术器械,其中所述控制器被配置为基于电流消耗的变化率而检测所述电流消耗的下降。
10.根据权利要求6所述的手术器械,其中所述钳夹组件包括联接至所述闭锁机构的驱动梁。
11.根据权利要求10所述的手术器械,所述闭锁机构被配置为在所述驱动梁向远侧移动时在非锁定状态与锁定状态之间转换。
12.根据权利要求11所述的手术器械,其中所述电流消耗的下降对应于所述闭锁机构的故障从而在所述驱动梁退回时转换至所述锁定状态。
13.根据权利要求12所述的手术器械,其中所述闭锁机构包括能在非锁定位置与锁定位置之间枢转的锁定构件。
14.根据权利要求13所述的手术器械,其中所述钳夹组件进一步包括壳体,所述壳体限定了安装在其中的凸起,所述凸起被配置为在所述驱动梁退回时与所述锁定构件接合。
15.根据权利要求6所述的手术器械,进一步包括联接至所述控制器的控制组件,其中所述控制器响应于所述电流消耗的下降而忽视用户输入。
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JP2014083440A (ja) | 2014-05-12 |
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US20160132026A1 (en) | 2016-05-12 |
US10838372B2 (en) | 2020-11-17 |
EP2724674B1 (en) | 2017-11-29 |
AU2013221973B2 (en) | 2018-05-24 |
JP2018140209A (ja) | 2018-09-13 |
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