CN105012015A - 用于手术器械的寿命终止传送系统 - Google Patents
用于手术器械的寿命终止传送系统 Download PDFInfo
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Abstract
本发明公开了一种用于手术器械的寿命终止传送系统。用于手术器械的动力手柄包括处理器和部件。该部件具有使用极限且被配置为当该部件接近其使用极限时，传送特征信号给处理器。特征信号被配置为：在使用手柄之前，直接给使用者提供该部件接近其使用极限的指示。
Description
相关申请的交叉引用
本申请要求于2104年4月7日提交的申请号为61/980,824的美国临时专利申请的权益和优先权，该专利的全部内容通过引用合并于此。
技术领域
本公开涉及手术器械，且更具体地，涉及将寿命终止的特征信号传送给使用者的手术器械。
背景技术
手术器械的动力部，典型地动力手柄，是可以在单次手术过程中重复使用多次的复杂的和昂贵的部件。另外，手术器械的动力部可以在使用后消毒以便在后来的手术过程中重复使用。
典型地，动力手术器械在出售前就预定了其的使用寿命。例如，在手术器械开发的工程阶段或销售阶段就可以确定动力手术器械的使用寿命。使用寿命通常由动力手术器械的圈数或使用次数来表示。
根据动力手术器械的使用类型或消毒次数，动力手术器械的一些部件可能在同一动力手术器械的其它部件失效之前出故障。然而，预定的使用寿命可能无法说明特定手术器械的使用类型或消毒次数。因此，预定的使用寿命可能会使动力手术器械过早地被卸除或停用(在其接近失效前)或动力手术器械可能在其达到预定使用寿命之前出故障。
发明内容
因此，本公开涉及监控手术器械的每一部件的实际使用情况的手术器械。手术器械基于其部件的实际使用情况来提供寿命终止的指示。该监控可以用来延长手术器械的可用寿命，因而降低手术过程的成本。另外，手术器械可以检测出手术器械内的部件的过早失效并提供指示给使用者以在预设使用寿命之前更换该手术器械。此外，手术器械可以将过早失效传送给制造商从而允许分析过早失效且有必要在其他现有的手术器械或目前正处于开发中的手术器械中解决该过早失效问题。
在本公开的方案中，一种用于手术器械的动力手柄包括处理器和部件。所述部件具有使用极限且被配置为当所述部件接近其使用极限时，传送特征信号给所述处理器。所述特征信号被配置为：在使用所述手柄之前，直接给使用者提供所述部件接近其使用极限的指示。所述部件可以为电动机、齿轮或电子部件中的其中一个。所述指示可以为视觉指示、听觉指示或触觉指示中的其中一种。
在方案中，所述特征信号为听觉特征信号且被配置为对于使用者可听得见的。
在一些方案中，所述特征信号被配置为提供所述部件的剩余寿命的指示。所述手柄可以包括显示器，其被配置为提供所述部件的剩余寿命的指示。
在某些方案中，所述手柄包括显示器，其被配置为在所述部件接近其使用极限时来提供指示给使用者。
在特定一些方案中，所述手柄包括传感器。所述传感器与第二部件相关且被配置为检测第二部件何时接近其使用极限。所述传感器可以被配置为当所述第二部件接近其使用极限时，传送第二特征信号给所述处理器。所述第二特征信号可以被配置为：在使用所述手柄之前，直接给使用者提供所述第二部件接近其使用极限的指示。
在本公开的其它方案中，动力手术器械包括末端执行器、手柄、以及具有使用极限的部件。所述手柄操作上与末端执行器相关且包括处理器。所述部件被配置为当所述部件接近其使用极限时，传送特征信号给所述处理器。所述特征信号被配置为：在使用所述手柄之前，直接给使用者提供所述部件接近其使用极限的指示。
在方案中，所述部件被布置在所述末端执行器内。
在本公开的又一方案中，对于使用手术器械的方法包括：致动手术器械；收集手术器械的部件的使用情况；将所述部件的使用情况与所述部件的使用极限进行比较；以及当所述部件接近其使用极限时，传送直接给使用者提供所述部件接近使用极限的特征信号给所述处理器。所述手术器械可以为在此公开的任何一种手术器械，且可以包括在此公开的任何一种手柄。比较部件的使用情况可以包括确定所述部件何时接近其使用极限。所述部件可以传送所述特征信号。
在方案中，收集所述部件的使用情况包括检测所述部件的使用情况的传感器。所述传感器可以传送所述特征信号。
在一些方案中，所述方法包括：当所述部件接近其使用极限时，停用所述手术器械。所述方法可以包括在使用所述手术器械之前，显示所述部件的剩余寿命。
在某些方案中，所述方法包括：利用被布置在所述手术器械内的传送器传送包括所述部件的使用情况的数据给距离所述手术器械遥远的处理器。所述处理器可以将所述部件的使用情况与所述部件的使用极限进行比较来确定所述部件何时接近其使用极限，且当所述部件接近其使用极限时，可以给使用者提供指示。
在特定的一些方案中，所述方法包括：利用被布置在所述手术器械内的传送器传送包括所述部件的使用情况的数据给云并在距离所述手术器械遥远的位置处分析所述数据。所述方法可以包括从云读取数据并从所述数据中确定是否需要提供所述手术器械。
此外，为了达到一致的程度，在此描述的任何一种方案可以与在此描述的其他任何一种方案或其他所有方案相结合使用。
附图说明
在下文中参照附图描述本公开的各种方案，其中：
图1是根据本公开的手术系统的部件的示意图，示出了合乎比例的手术器械和处理器；
图2是示出了图1的手术器械的手柄的内部部件的剖视图；
图3是图1的手术器械的手柄的后视立体图；
图4是图1的手术器械的手柄的另一立体图，示出了显示警告状态的显示器；以及
图5是示出了根据本公开的使用手术器械方法的流程图。
具体实施方式
现在参照附图详细描述本公开的实施例，其中在几幅附图的每幅附图中相同附图标记指代相同的或对应的元件。在本文中使用时，术语“临床医师”是指医生、护士或任何其他一种保健提供者并可以包括支援人员。在整篇说明书中，术语“近侧”是指设备或其部件离临床医师最近的部分，而术语“远侧”是指设备或其部件离临床医师最远的部分。
现在，参照图1，手术系统1包括动力手术器械10和处理器60。手术器械10可以经由下文详述的网络50或云55来与处理器60通信。手术器械10包括动力手柄30、联接至手柄30并从手柄30延伸出的接合器18、以及联接至接合器18且从接合器18延伸出的末端执行器19。末端执行器19被配置为作用在组织上(例如，驱动吻合钉进入组织、施加能量至组织、切割组织、施加夹具至组织、操纵组织等)。
参照图2，手柄30包括被布置在其中的部件110至部件180。部件110至部件180被配置为协作地操纵末端执行器19来作用在组织上和/或来改变末端执行器19相对于手柄30的位置。例如，当驱动电动机110被致动时，驱动电动机110使主动齿轮120转动以致于从动齿轮130使操作上与末端执行器19的一个或多个功能有关的传动轴135旋转。在以下三个共同拥有且共同未决的美国专利申请中公开了具有动力手柄的这种手术器械：第一个于2007年8月21日提交，序列号为11/894,959，且于2008年10月16日公开，公开号为2008/0255413；第二个于2011年12月20日提交，序列号为13/331,047，且于2012年4月12日公开，公开号为2012/0089131；第三个于2012年5月31日提交，序列号为13/484,975，且于2012年10月4日公开，公开号为2012/0253329，每一个专利的全部内容通过引用合并于此。
在实施例中，手术器械10的部件110至部件180与处理器22进行有线的或无线的通信。处理器22被布置在手柄30内。然而，也在本公开范围内的是，处理器22可以被布置在手术器械10内的任何位置(例如，接合器18或末端执行器19)。
手柄30的部件110至部件180中的一个或多个部件通过各自的特征信号传送部件110至部件180的实际使用情况给处理器22。部件110至部件180的实际使用情况可以包括但不限于：部件的使用数量、部件的温度、由部件所施加的力、施加给部件的力或对部件的损坏情况。每一个特征信号可以为电子信号或声信号。例如，根据本公开的特征信号的非限制性的示例包括部件的共振、部件的电容量、部件的电感、部件的声振动等。
处理器22分析特征信号来确定手术器械10的实时状况，包括但不限于，手术器械10剩余的使用次数、手术器械10是否接近其寿命终止、手术器械10是否超过其使用寿命等。处理器22提供手术器械10的状况指示给使用者。处理器22可以提供视觉反馈、听觉反馈或触觉反馈作为手术器械10的状况指示。也在本公开范围内的是，当特征信号为声信号时，由部件110至部件180所传送的特征信号对于使用者来说可以为可听到的，以提供关于部件的实际使用情况或手术器械10的状况的指示。
手柄30可以包括被布置在其内且与处理器22通信的传感器20。另外地或替代地，传感器20可以被布置在接合器18或末端执行器19内。传感器20均可为电触点、近程传感器、应变仪、光学传感器、光电二极管、机械的或金属的传感器，或其组合。传感器20均监控一个或多个相关的部件110至部件180的使用情况或磨损情况。
传感器20均可与处理器22进行有线的或无线的通信从而提供特征信号给处理器22。传感器20的特征信号大体上类似于如上所详述的部件110至部件180的特征信号则出于简洁的原因，将在此不再详述。
参照图1和图2，处理器22利用传送器24传送可以包括特征信号、部件的实际使用情况、或手术器械10的状况的数据给距离手术器械10遥远的处理器60。传送器24可以与处理器22为一体的。数据从传送器24向处理器60的传送可以通过有线的或无线的连接。传送器24可以直接发送数据至处理器60或可以通过网络50发送数据至处理器60。另外地或替代地，传送器24可以发送数据至云55，然后处理器60可以从云55检索数据。也在本公开范围内的是，传感器20或部件110至部件180中的一个或多个可以通过无线连接发送数据至云55或处理器60。另外地或替代地，处理器60可以传送数据至处理器22。在本公开范围内的是，处理器60接收来自部件110至部件180中一个或多个部件的特征信号。
在此描述的无线连接的示例包括但不限于：射频、光感(optical)、WIFI、蓝牙(用于从固定的和移动的设备进行短距离数据交换(使用短的无线电波)、创建个人区域网(PANs)的开放式无线协议)、(用于无线个人区域网(WPANs)的基于IEEE802.15.4-2003标准的采用小型的、低功率的数字无线电通信的一套高层通信协议的规范)等。在本公开范围内的是，系统可以包括不同类型的无线连接的组合。
另外参照图3，动力手柄30包括握把31、使用者接口32以及显示器36。握把31可以被布置与如图1所示的接合器18或末端执行器19大体在同一直线上，或可以与接合器18或末端执行器19(例如，手枪式握把)大体正交。使用者接口32包括控制接口或按钮33，来执行手术器械10的各种功能(例如，打开和闭合末端执行器19的钳夹构件、相对于接合器18致动末端执行器19、使末端执行器19围绕其纵轴旋转、从末端执行器19发射吻合钉、利用末端执行器19传递电外科能量等)。使用者接口32可以包括控制接口33，其被布置在握把31和/或显示器36上或邻近握把31和/或显示器36。控制接口33可以为操作杆、开关、按钮、触屏、键盘、数字转换器等。
继续参照图3，显示器36定位于手柄30上，以致于在使用手柄30的过程中显示器对于使用者来说是可看得见的。显示器36显示手术器械10的状况的指示，包括但不限于，剩余的使用次数(图3)、警告消息(图4)、部件110至部件180的实际使用情况(例如，留在钉仓(未示出)内的吻合钉的百分比、末端执行器19的关节式运动的角度、末端执行器19绕接合器18的纵轴的径向位置、部件110至部件180的温度等)、关于手术器械10的环境条件(例如，邻近末端执行器19的温度、邻近手柄30的温度等)。
显示器36允许手术器械的使用者在完成操作前提前更换接近或将超过其使用寿命的手术器械10。另外，通过监控手柄30内的部件(例如部件110至部件180)的使用情况，可以基于手柄30的实际使用情况来确定所计算出的手柄30的使用寿命。实际使用情况可以包括手柄30的每一个部件(例如，部件110至部件180)的圈数或使用次数，和/或每一个部件的使用类型(例如，由齿轮施加的转矩或施加在齿轮上的转矩或由电动机施加的转矩、部件的使用持续时间)和/或部件110至部件180的工作温度。计算出的使用寿命可能会大于手术器械10的预定使用寿命，总体上，使得能够延长手术器械10的寿命，因而，降低了手术的总成本。
例如，诸如关节式运动齿轮180的单个部件可能具有使用次数为50的预定使用寿命。当利用使用极限来计算手术器械10的使用寿命时，原来采用每次使用时关节式运动平均次数来计算手术器械的预定使用寿命。在这种情况下，如果确定每6次使用中做1次关节式运动，那么手术器械10的预定使用寿命将为使用300次。然而，如果在实际使用过程中，每10次使用中仅1次做关节式运动，那么基于关节式运动齿轮180的实际使用次数而计算出的手术器械10的使用寿命将为使用500次。因此，计算出的手术器械的使用寿命将比预定使用寿命多出使用200次。而且，如果关节式运动齿轮180的实际使用次数大于每6次使用中做1次关节式运动(例如，每5次或更少次使用中做1次关节式运动)，那么基于关节式运动齿轮180的实际使用次数，手术器械10可能在过早失效之前就卸除不用了。另外，可以由制造商通过从关节式运动齿轮180相对于手术器械10的其它部件的实际使用次数的云55接收全局数据来更新关节式运动齿轮180相对于手术器械的其它使用情况的实际使用次数。应该理解地是，响应于手术器械10的任何一个部件的使用次数，可以采用类似于以上详述示例的方式来调整计算出的使用寿命。
在一些实施例中，传感器20可以检测出单个部件110至部件180的故障或即将发生的故障，并发送特征信号以警告使用者来更换手柄30或手术器械10。传感器20可以发送诸如声音的听觉特征信号，或传感器20可以发送电子特征信号给向处理器22，来提供如图4中所示的显示器36上的视觉指示。在一些实施例中，当处理器22接收到对应于手柄30或手术器械10的部件(例如，部件110至部件180)的故障的特征信号时，处理器22可以禁止后面使用手柄30。另外地或替代地，处理器22可以提供故障或即将发生的故障的听觉指示。另外，故障或即将发生的故障可以作为数据被传送指云55(图1)或处理器60。
参照图5，阐述了允许使用或停用手术器械10的过程200。可以预期到，处理器22可以利用过程200来允许使用或停用手术器械10。另外，处理器22可以计算且提供手术器械10的剩余寿命的视觉指示。开始，使用者给手术器械10加电或通电(步骤210)。可以使用能源或电池170(图2)来给手术器械10的部件供电。处理器22收集手术器械10的每一个部件(例如，部件110至部件180)的使用情况。使用情况可以包括实际使用次数或在特定条件下的实际使用次数(例如，具有超限转矩的驱动电动机110的旋转)。处理器22然后将每一个部件的实际使用情况与每一单独部件的使用极限作比较(步骤230)。
如果每一个部件的实际使用情况未达到每一个部件的使用极限，则处理器向使用者发送准备使用手术器械的指示(步骤240)。在手术器械达到显示器36上计算出的使用寿命之前，处理器22可以向使用者提供计算出的手术器械10剩余的使用次数的视觉指示。计算出的手术器械10的使用次数可以是在部件达到其使用极限之前具有最少剩余使用次数的部件的使用次数。使用者然后可以使用手术器械10(步骤250)。在使用手术器械10之后，处理器22重复收集手术器械10的每一个部件的使用情况(步骤220)。
如果任何一个部件的实际使用情况超过或超出对于相应部件的使用极限，那么处理器22经由视觉反馈、听觉反馈、或触觉反馈来给使用者提供故障指示(步骤260)。例如，如图4所示，处理器22可以向显示器36发送更换手柄30的视觉指示。另外，处理器22可以停用手柄30或器械10(步骤270)。另外地或替代地，处理器22可以提供手术器械10的可更换的部件(未示出)(如吻合钉钉仓、可卸除的电池、末端执行器)需要更换的指示。如果可更换的部件被更换，则处理器可以返回来收集每一个部件的使用情况(步骤220)。此外，传感器(例如，其中一个传感器20)、处理器22或部件(例如，部件110至部件180)可以提供听觉特征信号，指示手术器械10超出其使用极限且必须更换。听觉特征信号可以为默认声音或对于超出其使用极限的部件来说所特有的声音。
另外地或替代地，处理器60可以从处理器22接收在步骤220过程中所收集的数据，且将手术器械10的每一个部件的实际使用情况与每一个部件的使用极限进行比较，并向处理器22传送特征信号来允许使用手术器械10。也在本公开范围内的是，处理器60直接从手术器械10一个或多个部件(例如部件110至部件180)接收特征信号。
在本公开的方案中，传送器24发送数据至云55。手术器械10的制造商或许能够读取云55中的数据。手术器械10的制造商可以使用数据来确定是否任何一个部件(例如，部件110至部件180)正过早失效(即，部件在预期之前达到相应的使用极限)。如果一个或多个部件正过早失效，则制造商可以利用数据来改进在未来修订版的手术器械10中正过早失效的部件，来警告其它客户当心过早失效，或在其它手术器械10用于患者之前不再使用其它手术器械10。
在本公开的其它方案中，手术器械10的部件的实际使用情况可被处理器60利用来确定对于设施机构(例如，医院、诊所、医院网络)的供应需求(例如，吻合钉钉仓、夹具仓、末端执行器等)。处理器60可以经由屏幕显示器、自动供应命令、邮件和/或文本来传送供应需求。
虽然已经在附图中示出了本公开的若干实施例，但是本公开并不旨在限于此，因为本公开的范围应该是与本领域将允许的以及同样理解说明书的范围一样广。还设想了上述实施例的任何组合且均在所附权利要求的范围内。因此，上述说明书不应该视为限制，仅仅是一些特定实施例的范例。本领域的技术人员将设想到在所附权利要求的范围和精神内的其他的修改。
Claims (20)
1.一种用于手术器械的动力手柄，所述手柄包括：
处理器；以及
部件，其具有使用极限，所述部件被配置为当所述部件接近其使用极限时，传送特征信号给所述处理器，所述特征信号被配置为：在使用所述手柄之前，直接给使用者提供所述部件接近其使用极限的指示。
2.根据权利要求1所述的手柄，其中所述部件为电动机、齿轮或电子部件中的至少其中一个。
3.根据权利要求1所述的手柄，其中所述指示为视觉指示、听觉指示或触觉指示中的至少其中一种。
4.根据权利要求1所述的手柄，其中所述特征信号为听觉特征信号且被配置为对于使用者可听得见的。
5.根据权利要求1所述的手柄，其中所述特征信号被配置为提供所述部件的剩余寿命的指示。
6.根据权利要求5所述的手柄，进一步包括显示器，所述显示器被配置为提供所述部件的所述剩余寿命的指示。
7.根据全要求1所述的手柄，进一步包括显示器，所述显示器被配置为在所述部件超过其使用极限时来提供指示。
8.根据权利要求1所述的手柄，进一步包括传感器，所述传感器与第二部件相关且被配置为检测所述第二部件何时接近其使用极限。
9.根据权利要求8所述的手柄，其中所述传感器被配置为当所述第二部件接近其使用极限时，传送第二特征信号给所述处理器，所述第二特征信号被配置为：在使用所述手柄之前，直接给使用者提供所述第二部件接近其使用极限的指示。
10.一种动力手术器械，包括：
末端执行器；
手柄，其操作上与末端执行器相关，所述手柄包括处理器；以及
部件，其具有使用极限，所述部件被配置为当所述部件接近其使用极限时，传送特征信号给所述处理器，所述特征信号被配置为：在使用所述手柄之前，直接给使用者提供所述部件接近其使用极限的指示。
11.根据权利要求10所述的手术器械，其中所述部件被布置在所述末端执行器内。
12.根据权利要求10所述的手术器械，进一步包括与第二部件相关的传感器，所述传感器被配置为检测出所述第二部件何时接近其使用极限，所述传感器被配置为当所述第二部件接近其使用极限时，传送第二特征信号给所述处理器，所述第二特征信号被配置为：在使用所述手柄之前，直接给使用者提供所述第二部件接近其使用极限的指示。
13.一种对于使用手术器械的方法，所述方法包括：
收集手术器械的部件的使用情况，所述手术器械包括：
处理器；
具有使用极限的所述部件；以及
手柄，其操作上与末端执行器相关；
将所述部件的所述使用情况与所述部件的所述使用极限进行比较从而确定所述部件何时接近其使用极限；以及
当所述部件接近其使用极限时，传送特征信号给所述处理器，所述特征信号直接给使用者提供所述部件接近其使用极限的指示。
14.根据权利要求13所述的方法，其中所述部件传送所述特征信号。
15.根据权利要求13所述的方法，其中收集所述部件的使用情况包括传感器检测所述部件的所述使用情况，并且其中所述传感器传送所述特征信号。
16.根据权利要求13所述的方法，进一步包括：当所述部件超过其使用极限时，停用所述手术器械。
17.根据权利要求13所述的方法，进一步包括：利用被布置在所述手术器械内的传送器传送包括所述部件的所述使用情况的数据给距离所述手术器械遥远的处理器，所述处理器将所述部件的所述使用情况与所述部件的使用极限进行比较来确定所述部件何时接近其使用极限，且当所述部件接近其使用极限时，经由所述手柄给使用者提供指示。
18.根据权利要求13所述的方法，进一步包括：利用被布置在所述手术器械内的传送器传送包括所述部件的所述使用情况的数据给云并在距离所述手术器械遥远的位置处分析所述数据。
19.根据权利要求18所述的方法，进一步包括：从所述云读取所述数据并从所述数据中确定是否需要提供所述手术器械。
20.根据权利要求13所述的方法，进一步包括：在使用所述手术器械之前，显示所述部件的剩余寿命。
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Also Published As
| Publication number | Publication date |
|---|---|
| EP2932913A1 (en) | 2015-10-21 |
| CA2872986A1 (en) | 2015-10-17 |
| CN110772342A (zh) | 2020-02-11 |
| US20150297200A1 (en) | 2015-10-22 |
| US20190223850A1 (en) | 2019-07-25 |
| AU2014262283A1 (en) | 2015-11-05 |
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Application publication date: 20151104 |