CN101224116A - 能够防止钉仓再次使用的外科器械及钉仓 - Google Patents
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Abstract
本发明涉及能够防止钉仓再次使用的外科器械及钉仓,所述外科器械包括控制单元和具有转发器的钉仓。控制单元被构造成将第一无线信号发送到所述转发器并从所述转发器接收第二无线信号,以根据第二无线信号确定所述转发器的第一电子态和第二电子态中的一个。
Description
本申请涉及下列同时提交的美国专利申请,它们的全部内容通过引用而包含于本申请中:
(1)J.Giordano等人的题为“在控制单元和传感器转发器之间进行无线通信的外科器械”(SURGICAL INSTRUMENT WITHWIRELESS COMMUNICATION BETWEEN CONTROL UNIT ANDSENSOR TRANSPONDERS)的美国专利申请(律师档案号060338/END5923USNP);
(2)J.Giordano等人的题为“在控制单元和远程传感器之间进行无线通信的外科器械”(SURGICAL INSTRUMENT WITHWIRELESS COMMUNICATION BETWEEN CONTROL UNIT ANDREMOTE SENSOR)的美国专利申请(律师档案号060339/END5924USNP);
(3)J.Giordano等人的题为“在控制单元和端部执行器之间具有通信元件的外科器械”(SURGICAL INSTRUMENT WITHELEMENTS TO COMMUNICATE BETWEEN CONTROL UNIT ANDEND EFFECTOR)的美国专利申请(律师档案号060340/END5925USNP);
(4)J.Swayze等人的题为“外科器械的消毒后程序”(POST-STERILIZATION PROGRAMMING OF SURGICALINSTRUMENTS)的美国专利申请(律师档案号060342/END5924USNP);
(5)F.Shelton等人的题为“互锁机构和包含互锁机构的外科器械”(INTERLOCK AND SURGICAL INSTRUMENT INCLUDINGSAME)的美国专利申请(律师档案号060343/END5928USNP);和
(6)F.Shelton等人的题为“具有增强的电池性能的外科器械”(SURGICAL INSTRUMENT WITH ENHANCED BATTERYPERFORMANCE)的美国专利申请(律师档案号060347/END5931USNP)。
技术领域
在各种实施方式中,所公开的发明总的涉及外科缝合和切割器械,其被构造和配置成用于从钉仓将成排缝钉施加到组织并切割施加的缝钉排之间的组织。更具体地,所公开的发明涉及用于马达驱动的外科缝合和切割器械中的电子控制,当该器械中存在用尽的钉仓(或者没有钉仓)时其防止组织的切割并将器械的使用限制为预定数目的缝合和切割操作。
背景技术
内窥镜外科器械常常优于传统的开放式外科装置,因为较小的切口易于缩短术后康复时间并减少并发症。因此,适于通过套管针的套管将远端的端部执行器设置在所需的外科部位的内窥镜外科器械领域得到了极大发展。这些远端的端部执行器(例如内切割器,抓钳,切割器,缝合器、夹施放器、进入装置、药物/基因治疗输送装置,以及使用超声波、RF、激光等的能量装置)以一些方式接合组织以达到诊断或治疗效果。
已知的外科缝合器包括同时在组织中形成纵向切口并将成排缝钉施加到切口的相对侧上的端部执行器。端部执行器包括一对协同动作的钳口构件,如果器械用于内窥镜或者腹腔镜应用,该钳口构件能够穿过套管通道。其中一个钳口构件容纳具有至少两个横向间隔的缝钉排的钉仓。另一个钳口构件限定了具有与钉仓中的成排缝钉对准的钉成形槽的钉砧。所述器械包括多个往复运动的楔形件,当向远端驱动时,这些楔子穿过钉仓中的开口并接合支撑缝钉的驱动器以使缝钉向着钉砧击发。
有利的是,端部执行器可以被设计成能够与外科缝合器重复使用。例如,一个患者可能需要一系列切割和缝合操作。针对每次操作更换整个端部执行器可能不那么经济,特别是该端部执行器被制得为了重复操作而具有一定强度和可靠性时。为此,钉仓通常被构造成一次性的,并且在外科缝合器的每次操作之前被装入端部执行器。
在Knodel等人的名称为“SURGICAL STAPLER INSTRUMENT”的美国专利No.5,465,895中描述了适于内镜应用的外科缝合器的一个例子,其中公开了具有明显闭合和击发动作的内切割器。由此,操作者能够将钳口构件闭合在组织上,以在击发前定位组织。一旦医生确认钳口构件正确夹持组织,医生可以单击发冲程或者多击发冲程(取决于该装置)击发该外科缝合器。击发该外科缝合器导致切割和缝合组织。同时切割和缝合避免了采用分别只进行切割和缝合的不同外科工具顺序执行这种动作可能导致的并发症。
能够在击发之前闭合在组织上的一个具体的优点是,医生能够借助内窥镜确认已经获得了切割的所需位置,包括在对置的钳口之间已经捕获了足够的组织。否则,对置的钳口可能被向一起拉得过近,尤其是在他们的远端挤紧,并且由此无法有效地在被切割的组织上成形闭合缝钉。另一个极端是,过量夹钳组织可能导致束缚和不完全击发。
由于闭合钳口并且同时执行切割和缝合操作所需的致动力(即,击发力,或者FTF)可能很大,诸如如上所述的手动缝合和切割器械可能无法被不能产生所需FTF的操作者使用,这些操作者在其他情况中可能是合格的操作者。因此,已经开发了动力驱动的切割和缝合器械来减小击发力(FTF)。这种器械通常结合有马达或者其他致动机构,适合用来增强或者替换用于执行切割和缝合操作的操作者生成力。
尽管动力驱动的器械提供了多种优点,但是需要防止在一定条件下器械的无意中击发。例如,击发未安装钉仓的器械或者击发安装了钉仓但钉仓用尽(例如在先击发)的器械,这可能导致切割组织而未能同时缝合而使流血量最小。迄今,防止在所述条件下动力驱动内切割器的操作的电子控制或者联锁装置已经利用设置在端部执行器中的工作电路来确定未用尽的钉仓是否已经被安装在端部执行器中。例如,Boiarski等人的题为“IDENTIFICATION DEVICE FORSURGICAL STAPLING INSTRUMENT”的美国专利US5529235公开了集成到钉仓的联锁电路,其具有响应于与击发操作同时施加到其上的机械力或电流而断开的保险丝。保险丝的断电状态经过相对于端部执行器定位的硬件化控制电路检测,以防止随后使用用尽的钉仓进行击发操作。以这种方式,断开保险丝使钉仓失效并防止其再次使用。
Swayze等人的题为“ELECTRONIC INTERLOCKS AND SURGICALINSTRUMENT INCLUDING SAME”的美国专利申请No.11/343439公开了设置在端部执行器中用于测定未用尽的钉仓是否已经安装的电传感器的使用。传感器可包括与马达或者其它电动致动机构串联的开关,当钉仓没有安装时或者当钉仓安装但被用尽时,使产生致动力所需的电流被防止。
虽然上述电子控制通常有效地防止了因疏忽造成的器械操作,但迄今为止电子装置在端部执行器中的设置需要将端部执行器与定位在端部执行器之外的其它电子元件(例如电源、马达、控制电路等)连接的电缆。在其中所述电子元件设置在器械的手柄中的情况下(如上面描述的参考),电缆通常借助连接端部执行器与手柄的轴布设。但是,在该方式中布设电缆不方便,增加了器械的复杂性和成本。
除了在未用尽的钉仓不存在的情况下防止器械的击发之外,还需要限制可由器械执行的击发操作的数目。
因此,非常需要用于动力致动的切割和缝合器械中的电子控制,防止因疏忽而造成的击发(例如切割但不缝合)同时避免与硬件化端部执行器电子设备有关的复杂性,并将器械使用限制为预定数目的击发操作。
发明内容
本申请公开了一种外科器械。在一种实施方式中,所述外科器械包括控制单元和包括转发器的钉仓。控制单元被构造成将第一无线信号发送到转发器并从转发器接收第二无线信号,以基于第二无线信号确定转发器的第一电子态和第二电子态中的一个。
在另一种实施方式中,所述器械包括具有用于切割物体的可动切割器械的端部执行器,和与端部执行器连接以致动切割器械的马达。切割器械的每次致动对应于外科器械的击发操作。外科器械还包括控制单元,用于计算外科器械的击发操作的数目并且用于当击发操作的数目等于预定数目时以电子方式改变所述器械的至少一个元件。所述改变的至少一个元件防止外科器械的击发操作超过预定数目。
本申请还公开了用于外科器械的钉仓。所述钉仓包括可从第一电子态转变成第二电子态的转发器。第一电子态是未击发状态的钉仓的指示,第二电子态是击发状态的钉仓的指示。
更具体地说,本发明涉及如下方面:
(1)、一种外科器械,包括:
具有转发器的钉仓;和
控制单元,用于将第一无线信号发送到所述转发器并从所述转发器接收第二无线信号,以便根据所述第二无线信号确定所述转发器的第一电子态和第二电子态中的一个。
(2)、根据第(1)项所述的外科器械,其中,所述第一电子态是钉仓未击发状态的指示,并且所述第二电子态是钉仓击发状态的指示。
(3)、根据第(2)项所述的外科器械,还包括端部执行器,所述端部执行器包括:
钉仓,其中所述钉仓包括设置在其中的滑块;
用于切割物体的机电致动的切割器械,其中所述切割器械的致动由所述控制单元控制;
纵向延伸的通道,用于以可拆卸的方式安放钉仓;和
与所述通道以可枢转的方式连接的钉砧,其中所述物体被定位在所述钉砧和所述通道之间;
其中,当所述切割器械被致动时,所述滑块由所述切割器械接合并被从位于所述钉仓近端的未击发位置纵向驱动经过所述钉仓到达位于所述钉仓远端的击发位置,所述滑块的未击发位置与所述钉仓的未击发状态对应,所述滑块的击发位置与所述钉仓的击发状态对应。
(4)、根据第(3)项所述的外科器械,其中,当确定为第一电子态时,所述控制单元允许所述切割器械的致动,当确定为第二电子态时,所述控制单元防止所述切割器械的致动。
(5)、根据第(4)项所述的外科器械,其中,与所述切割器械的致动基本上同时,所述控制单元将第三无线信号发送到所述转发器。
(6)、根据第(5)项所述的外科器械,其中,所述转发器包括至少一个元件,其由所述转发器响应于所述第三无线信号而电子地改变,从而使所述转发器从第一电子态转变到第二电子态。
(7)、根据第(6)项所述的外科器械,其中,每个所述至少一个元件选自如下的组,所述组包括电启动保险丝、热启动保险丝、电容器和存储装置。
(8)、根据第(4)项所述的外科器械,其中,所述转发器包括至少一个元件,其响应于所述切割器械受致动时的运动而电子地改变,被改变的所述至少一个元件使所述转发器从第一电子态转变到第二电子态。
(9)、根据第(8)项所述的外科器械,其中,每个所述至少一个元件选自如下的组,所述组包括机械启动保险丝和开关。
(10)、一种用于外科器械的钉仓,所述钉仓包括能够从第一电子态转变到第二电子态的转发器,其中所述第一电子态是所述钉仓未击发状态的指示,所述第二电子态是所述钉仓击发状态的指示。
(11)、根据第(10)项所述的钉仓,还包括设置在所述钉仓中待由所述外科器械的切割器械接合的滑块,其中当所述滑块与所述切割器械接合时,所述滑块被从位于所述钉仓近端的未击发位置纵向驱动经过所述钉仓到达位于所述钉仓远端的击发位置,所述滑块的未击发位置与所述钉仓的未击发状态对应,所述滑块的击发位置与所述钉仓的击发状态对应。
(12)、根据第(10)项所述的钉仓,其中,当所述转发器处于第一电子态时,所述转发器响应于由所述外科器械发送的无线信号以发送第一无线信号。
(13)、根据第(12)项所述的钉仓,其中,当所述转发器处于第二电子态时,所述转发器响应于由所述外科器械发送的无线信号以发送第二无线信号。
(14)、根据第(12)项所述的钉仓,其中,当所述转发器处于第二电子态时,所述转发器不响应于由所述外科器械产生的无线信号。
(15)、根据第(10)项所述的钉仓,其中,所述转发器包括至少一个元件,其由所述转发器响应于由所述外科器械发送的无线信号而电子地改变,被改变的所述至少一个元件使所述转发器从第一电子态转变到第二电子态。
(16)、根据第(15)项所述的钉仓,其中,每个所述至少一个元件选自如下的组,所述组包括电启动保险丝、热启动保险丝、电容器和存储装置。
(17)、根据第(11)项所述的钉仓,其中,所述转发器包括至少一个元件,其响应于所述切割器械受到致动时的运动而电子地改变,被改变的所述至少一个元件使所述转发器从第一电子态转变到第二电子态。
(18)、根据第(17)项所述的钉仓,其中,每个所述至少一个元件选自如下的组,所述组包括机械启动保险丝和开关。
(19)、一种外科器械,包括:
容纳钉仓的端部执行器;和
控制单元,用于将第一无线信号发送到设置在所述钉仓中的转发器并从所述转发器接收第二无线信号,以便根据第二无线信号确定所述转发器的第一电子态和第二电子态中的一个。
(20)、根据第(19)项所述的外科器械,其中,所述第一电子态是所述钉仓未击发状态的指示,并且所述第二电子态是所述钉仓击发状态的指示。
(21)、根据第(20)项所述的外科器械,其中,所述端部执行器包括:
用于切割物体的机电致动切割器械,其中所述切割器械的致动由所述控制单元控制;
用于可拆卸地安放所述钉仓的纵向延伸的通道;和
与所述通道枢转连接的钉砧,其中所述物体被定位在所述钉砧和所述通道之间;
其中,所述切割器械在被致动时与所述钉仓的滑块接合,以便驱动所述滑块从位于所述钉仓近端的未击发位置纵向经过所述钉仓到达位于所述钉仓远端的击发位置,所述滑块的未击发位置与所述钉仓的未击发状态对应,所述滑块的击发位置与所述钉仓的击发状态对应。
(22)、根据第(21)项所述的外科器械,其中,当所述第一电子态被确定时,所述控制单元允许所述切割器械的致动,当第二电子态被确定时,所述控制单元防止所述切割器械的致动。
(23)、根据第(22)项所述的外科器械,其中,与所述切割器械的致动基本上同时,所述控制单元将第三无线信号发送到所述转发器,所述第三无线信号使所述转发器从第一电子态转变到第二电子态。
(24)、根据第(22)项所述的外科器械,其中,当所述切割器械被致动时,所述切割器械使所述转发器从第一电子态转变到第二电子态。
(25)、一种防止外科器械中的钉仓再次使用的方法,所述方法包括:
将第一无线信号发送到设置在钉仓中的转发器;
从所述转发器接收第二无线信号,以根据所述第二无线信号确定所述转发器的第一电子态和第二电子态中的一个;
当第一电子态被确定时允许外科器械的切割器械致动;和
与所述切割器械的致动基本上同时地将所述转发器从第一电子态转变成第二电子态。
(26)、根据第(25)项所述的方法,包括当第二电子态被确定时防止所述切割器械的致动。
(27)、根据第(25)项所述的方法,其中,所述转发器的转变包括将第三无线信号发送到所述转发器,以电子地改变所述转发器的至少一个元件。
(28)、根据第(25)项所述的方法,其中,所述转发器的转变包括响应于当切割器械被致动时的运动而电子地改变转发器的至少一个元件。
(29)、一种处理外科器械的方法,包括:
获取外科器械,其中所述外科器械包括:
容纳钉仓的端部执行器;和
控制单元,其将第一无线信号发送到设置在所述钉仓中的转发器并从所述转发器接收第二无线信号,以根据第二无线信号确定转发器的第一电子态和第二电子态中的一个;
将外科器械灭菌;和
将外科器械存储在无菌容器中。
(30)、一种外科器械,包括:
具有用于切割物体的可动切割器械的端部执行器,
与所述端部执行器连接、用于致动所述切割器械的马达,所述切割器械的每次致动对应于外科器械的击发操作;和
控制单元,用于计算外科器械的击发操作的数目并在击发操作的数目等于预定数目时电子地改变外科器械的至少一个元件,其中被改变的至少一个元件防止外科器械的击发操作超过预定数目。
(31)、根据第(30)项所述的外科器械,其中,每个所述至少一个元件选自包括电启动保险丝和开关的组。
附图说明
本发明的各种实施方式在本文中通过结合下列附图的例子来描述,其中:
图1和2是根据本发明的各种实施方式的外科器械的透视图;
图3A是根据本发明的各种实施方式的端部执行器的分解图;
图3B是图3A的切割器械的透视图;
图4和5是根据本发明的各种实施方式的器械的端部执行器和轴的分解图;
图6是根据本发明的各种实施方式的端部执行器的侧视图;
图7是根据本发明的各种实施方式的器械的手柄的分解图;
图8和9是根据本发明的各种实施方式的手柄的局部透视图;
图10是根据本发明的各种实施方式的手柄的侧视图;
图11和12示出了可根据本发明的各种实施方式被使用的比例传感器;
图13是根据本发明的各种实施方式的控制单元的框图;
图14至16是根据本发明的各种实施方式的外科器械的透视图;
图17是根据各种实施方式的钉仓的一部分的仰视图;
图18和20是根据各种实施方式的转发器的电路图;
图19是根据各种实施方式的钉仓的一部分的仰视图;
图21是根据各种实施方式的钉仓托架的透视图;
图22和23是根据各种实施方式的转发器的电路图;
图24是根据各种实施方式的防止外科器械中钉仓的再次使用的方法的流程图;和
图25是根据各种实施方式的防止马达操作的电路的框图;
图26是根据本发明的各种实施方式的外科器械的透视图。
具体实施方式
本发明的各种实施方式总体上涉及具有至少一个转发器和用于从控制单元将功率信号和/或数据信号传输到转发器(一个或多个)的部件的外科器械。本发明可被用于任何类型的包括至少一个转发器的外科器械,诸如内窥镜或者腹腔镜外科器械,但是对于其中器械的一些零件诸如自由旋转接头防止或者抑制导线连接到传感器(一个或多个)的外科器械特别有用。在描述系统的各个方面之前,首先描述其中本发明的实施方式可被使用的一种类型的外科器械-内窥镜缝合和切割器械(即内切割器)。
图1和2示出了根据本发明的各种实施方式的外科切割和紧固器械10。所示出的实施例是内镜器械,总体而言,此处示出的器械10的实施例是内镜外科切割和紧固器械10。但是,应当理解的是,根据本发明的其他实施方式,所述器械可以是非内镜外科切割和紧固器械,诸如腹腔镜器械。
在图1和2中示出的外科器械10包括手柄12、轴14和在关节运动枢轴18处枢转连接到轴14的进行关节运动的端部执行器16。端部执行器16的正确设置和定向可通过手柄12上的控制器来进行,包括(1)旋钮17,用于使位于轴14的自由转动关节19处的闭合管(将在下面结合图4至5详细描述)旋转从而旋转端部执行器16,和(2)关节运动控制器20,用于使端部执行器16围绕关节运动枢轴18进行旋转关节运动。在所示的实施方式中,端部执行器16被构造成作为用于夹钳、切割和缝合组织的内切割器,但是在其它实施方式中,也可使用不同类型的端部执行器,诸如用于其它类型的外科装置的端部执行器,例如抓钳、切割器、缝合器、夹施放器、进入装置、药物/基因治疗装置、超声、RF或者激光装置等。
器械10的手柄12可包括闭合扳机22和用于致动端部执行器16的击发扳机24。应当理解,具有用于不同外科任务的端部执行器的器械可具有不同数量或者类型的扳机或用于操作端部执行器16的其他适合的控制器。所示出的端部执行器16通过优选的细长轴14与手柄12隔开。在一种实施方式中,器械10的操作者/医生可通过使用关节控制器20使端部执行器16相对于轴14进行关节运动,所述关节控制器20如在Hueil等人的名称为“SURGICAL INSTRUMENTHAVING AN ARTICULATING END EFFECTOR”的未决的美国专利申请No.11/329,020中更详细描述的,该文献通过参考结合入本文。
在本实施例中,除了其他的,端部执行器16包括缝钉通道26和可枢转移动的夹钳构件诸如钉砧28,他们保持隔开,确保夹钳在端部执行器16中的组织的有效缝合和切割。手柄12包括手枪式握把30,由医生朝着该手枪式握把30枢转地拉动闭合扳机22使得端部执行器16的钉砧28朝着缝钉通道26夹钳或者闭合,由此夹钳定位在钉砧28和通道26之间的组织。击发扳机24位于闭合扳机22的更远侧。一旦闭合扳机22如下面将更详细描述的那样锁定在闭合位置,击发扳机24可朝着手枪式握把30略微转动,从而可由操作者用一只手够到。然后操作者可朝着手枪式握把30枢转地拉动击发扳机24,以便缝合和切割夹钳在端部执行器16中的组织。在其他实施方式中,除了钉砧28外可使用其它类型的夹钳构件,诸如例如对置的钳口等。
应当理解,此处使用的术语“近侧”和“远侧”是相对于抓持器械10的手柄12的操作者而言。因此,端部执行器16相对于更近侧的手柄12而言位于远侧。还应当理解,为了方便和清楚,此处使用的空间术语诸如“垂直”和“水平”是相对于附图而言的。但是,可在多种方位使用外科器械,并且这些术语并不是限制性的和绝对的。
可首先致动闭合扳机22。一旦医生对端部执行器16的定位满意,医生可将闭合扳机22向回拉动到其靠近手枪式握把30的完全闭合的锁定位置。然后可致动击发扳机24。如下面将更完整地描述地,当医生移开压力时,击发扳机24返回到张开位置(如图1和2所示)。位于手柄12上的释放按钮32在被压下时可松开锁定的闭合扳机22。使用释放按钮32锁定和解锁闭合扳机22的各种构造在Shelton,IV等人的名称为“MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH LOADING FORCE FEEDBACK”的未决美国专利申请No.11/343,573中有说明,该文献通过引用结合入本文。
图3A是根据各种实施方式的端部执行器16的分解图,图3B是图3A的切割器械的透视图。如所阐述的实施方式所示,除了前面提及的缝钉通道26和钉砧28,端部执行器16可包括切割器械34、可拆卸地置于(例如安装)通道26中的钉仓38、设置于钉仓38中的滑块36以及螺纹轴40。
钉砧28可在连接到通道26的近端上的枢轴点42处可枢转地张开和闭合。钉砧28还可包括位于其近端的凸片44,用于插入机械闭合系统(在下面说明)的组成元件中,以便张开和闭合钉砧28。当致动闭合扳机22时,也就是由器械10的操作者向内拉动闭合扳机22时,钉砧28可绕着枢轴点42枢转到夹钳或闭合位置。如果对端部执行器16的夹钳满意,操作者可致动击发扳机24,如在下面更详细说明的,击发扳机24使切割器械34沿着通道26纵向地运动。
如图所示,切割器械34包括上导销46,这些上导销46进入钉砧28中的钉砧槽48,以便在切割和缝钉成形过程中确认和辅助将钉砧28保持在接通状态。通过通道26中的纵向开口54的引导使切割器械34的中部销50沿着通道26的顶面滑动、同时使其底脚52沿着通道26的底面相对地滑动而由切割器械34进一步保持通道26和钉砧28之间的间隔。位于上导销46和中部销50之间的朝向远侧的切割表面56切割夹钳的组织,同时,朝向远侧的表面58通过接合滑块36并将滑块36逐渐地驱动经过钉仓38、从位于钉仓38近端的未击发位置驱动到位于钉仓38远端的击发位置而致动钉仓38。当滑块36处于未击发位置时,钉仓38处于未击发或未用尽状态。当滑块36处于击发位置时,钉仓38处于击发或用尽状态。钉仓38的致动使得缝钉驱动器60进行向上凸起运动,从而将缝钉62从形成于钉仓38中的向上开口的缝钉孔64驱动出来。随后缝钉62抵靠钉砧28的钉成形下表面66成形。钉仓托架68从底部包围钉仓38的其他组成元件,以便将他们保持就位。钉仓托架68包括向下开口槽70,其位于通道26中的纵向开口54上方。钉仓38的下表面和通道26的上表面形成击发驱动槽200(图6),在切割器械34的远侧运动和近侧运动过程中中部销50经过该击发驱动槽200。滑块36可以是钉仓38的一体组成元件,从而在切割操作之后缩回切割器械34时该滑块36不会缩回。在Shelton,IV等人的名称为“SURGICALSTAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM”的美国专利No.6,978,921中更详细地公开了这种两冲程切割和紧固器械,该文献通过引用结合入本文。
应当理解,尽管此处描述的器械10的实施方式采用钉合被切割的组织的端部执行器16,但是在其他实施方式中可以使用用于紧固或密封被切割组织的不同的技术。例如,也可以使用采用RF能量或者粘合剂的端部执行器。Yates等人的名称为“ELECTROSURGICALHEMOSTATIC DEVICE”的美国专利No.5,709,680以及Yates等人的名称为“ELECTOSURGICAL HEMOSTATIC DEVICE WITH RECESSED AND/OROFFSET ELECTRODES”的美国专利No.5,688,270公开了使用RF能量紧固被切割的组织的切割器械,这两篇文献通过引用被结合入本文。Morgan等人的名称为“SURGICAL STAPLING INSTRUMENTSSTRUCTURED FOR DELIVERY OF MEDICAL AGENTS”的美国专利申请No.11/267,811和Shelton IV等人的名称为“SURGICAL STAPLINGINSTRUMENTS STRUCTURED FOR PUMP-ASSISTED DELIVERY OF MEDICALAGENTS”的美国专利申请No.11/267,383公开了使用粘合剂紧固被切割的组织的切割器械,这两篇文献通过引用被结合入本文。因此,尽管此处的说明提及切割/缝合操作等,但是应当认识到,这是示例性实施方式,并不意味着限制。也可使用其他组织紧固技术。
图4和5是根据各种实施方式的端部执行器16和轴14的分解图,图6是侧视图。如所阐述的实施方式所示,轴14可包括通过枢转连接件76可枢转地连接的近侧闭合管72和远侧闭合管74。远侧闭合管74包括开口78,钉砧28上的凸片44插入开口78,以便张开和闭合钉砧28,如下面更详细说明的。近侧脊管79设置在闭合管72和74内。主旋转(或近侧)驱动轴80设置在近侧脊管79内,借助锥齿轮组件84与次(或远侧)驱动轴82连接。次驱动轴82连接到驱动齿轮86,该驱动齿轮86与螺纹轴40的近侧驱动齿轮88接合。竖直的锥齿轮84b位于近侧脊管79的远端的开口90中,并在其中枢转。远侧脊管92可用于包围次驱动轴82和驱动齿轮86、88。总体上,主驱动轴80、次驱动轴82和关节运动组件(例如锥齿轮组件84a-c)在此处有时被称作“主驱动轴组件”。
位于缝钉通道26的远端处的轴承94接收螺纹轴40,允许螺纹轴40相对于通道26自由旋转。螺纹轴40可与切割器械34的螺纹开口(未示出)接界,从而螺纹轴40的旋转使切割器械34向远侧或近侧(取决于旋转的方向)移动通过缝钉通道26。由此,当通过击发扳机24的致动而使主驱动轴80旋转时(如下面将更详细说明的),锥齿轮组件84a-c使次驱动轴82旋转,由于驱动齿轮86、88的接合,次驱动轴82又使得切割器械34沿着通道26纵向运动,从而切割夹钳在端部执行器16内的任何组织。滑块36可由例如塑料制成,并且可具有倾斜的远侧表面。随着滑块36经过通道26,倾斜的远侧表面向上顶起缝钉驱动器60,该缝钉驱动器60又推起或驱动钉仓38中的缝钉62穿过夹钳的组织并抵靠在钉砧28的钉成形下表面66上,由此缝合被切割的组织。当缩回切割器械34时,切割器械34和滑块36脱离接合,由此将滑块36留在通道26的远端。
图7至10示出了马达驱动的内切割器、尤其是其手柄12的一种示例性实施方式,手柄12提供了切割器械34在端部执行器16中展开和加载力的操作者反馈。另外,在缩回击发扳机24时该实施方式可使用操作者提供的能量,以为该装置赋能(所谓的“动力辅助”模式)。如所阐述的实施方式所示,手柄12包括外部下侧件96、98和外部上侧件100、102,它们装配在一起,在总体上形成手柄12的外部形状。电池104可被设置在手柄12的手枪式握把30部分中。电池104可根据任何合适的结构或化学物质构造,包括例如锂离子化学物质诸如LiCoO2或LiNiO2、镍金属氢化物化学物质等。电池104为设置在手柄12的手枪式握把30部分的上部的马达106供能。根据各种实施方式,马达106可以是DC整流驱动马达,具有大约5000至100,000RPM的最大转数。马达106可驱动90度锥齿轮组件108,该锥齿轮组件108包括第一锥齿轮110和第二锥齿轮112。锥齿轮组件108可驱动行星齿轮组件114。行星齿轮组件114可包括连接到驱动轴118的小齿轮116。小齿轮116可驱动配合环形齿轮120,该环形齿轮120通过驱动轴124驱动斜齿轮鼓122。环126可旋到斜齿轮鼓122上。由此,当马达106旋转时,通过介于其间的锥齿轮组件108、行星齿轮组件114和环形齿轮120使环126沿着斜齿轮鼓122行进。
手柄12还可包括与击发扳机24相关联的运转马达传感器128,以便检测操作者向着手柄12的手枪式握把30部分向内拉动(或“闭合”)击发扳机24的时刻,由此通过端部执行器16致动切割/缝合操作。传感器128可以是比例传感器诸如例如变阻器或者可变电阻器。当向内拉动击发扳机24时,传感器128检测到运动并发出表明被输送到马达106的电压(或能量)的电信号。当传感器128是可变电阻器等时,马达106的转数可与击发扳机24的运动量大致成比例。也就是,如果操作者仅仅拉动或略微闭合击发扳机24,马达106的转速相对较低。当将击发扳机24完全向内拉(或处于完全闭合位置)时,马达106的转数为最大。换句话说,操作者越是用力地拉动击发扳机24,施加到马达106的电压越大,从而导致转速更高。在另一种实施方式中,例如,控制单元(如下所述)可根据来自传感器128的输入而输出PWM控制信号到马达106,以便控制马达106。
手柄12可包括邻近击发扳机24的上部的手柄中部件130。手柄12还可包括连接到位于手柄中部件130上的柱和击发扳机24上的柱之间的偏压弹簧132。偏压弹簧132可将击发扳机24偏压到其完全张开位置。这样,当操作者松开击发扳机24时,偏压弹簧132将把击发扳机24拉到其张开位置,由此去除传感器128的致动,由此停止马达106的旋转。而且,借助于该偏压弹簧132,无论何时操作者闭合击发扳机24,操作者将会体验到对闭合操作的阻力,由此为操作者提供马达106施加的转数多少的反馈。另外,操作者可以停止缩回击发扳机24,由此去掉传感器128上的力,从而停止马达106。这样,操作者可停止端部执行器16的展开,由此为操作者提供切割/紧固操作的控制手段。
斜齿轮鼓122的远端包括驱动环形齿轮136的远侧驱动轴134,该环形齿轮136与小齿轮138啮合。小齿轮138连接到主驱动轴组件的主驱动轴80。这样,马达106的旋转导致主驱动轴组件旋转,这又导致端部执行器16的致动,如上所述。
旋到斜齿轮鼓122上的环126可包括柱140,该柱140置于带槽的臂144的槽142中。带槽的臂144在其相对端148处具有开口146,开口146容纳连接在手柄外部下侧件96、98之间的枢销150。枢销150还设置成穿过击发扳机24中的开口152和手柄中部件130中的开口154。
另外,手柄12还可包括反转马达(或冲程结束)传感器156和停止马达(或开始冲程)传感器158。在各种实施方式中,反转马达传感器156可以是位于斜齿轮鼓122的远端处的常断限制开关,使得旋在斜齿轮鼓122上的环126在其到达斜齿轮鼓122的远端时接触并接通反转马达传感器156。当反转马达传感器156接通时其向控制单元发送信号,控制单元又向马达106发出信号,使马达106反向,由此在切割操作后缩回端部执行器16的切割器械34。
停止马达传感器158可以例如是常通限制开关。在各种实施方式中,其可以位于斜齿轮鼓122的近端,使得环126在到达斜齿轮鼓122的近端时断开开关158。
在操作过程中,当器械10的操作者向回拉动击发扳机24时,传感器128检测击发扳机24的使用,并向控制单元发送信号,控制单元又向马达106发出信号,以使马达106以例如与操作者向回拉击发扳机24的用力程度成比例的速率向前旋转。马达106的向前旋转又导致位于行星齿轮组件114的远端处的环形齿轮120旋转,由此使得斜齿轮鼓122旋转,导致旋在斜齿轮鼓122上的环126沿着斜齿轮鼓122向远侧行进。斜齿轮鼓122的旋转还如上所述地驱动主驱动轴组件,主驱动轴组件又导致端部执行器16中的切割器械34的使用。也就是,使得切割器械34和滑块36纵向地经过通道26,由此切割夹钳在端部执行器16中组织。而且,端部执行器16的缝合操作发生在使用缝合型端部执行器的实施方式中。
在完成端部执行器16的切割/缝合操作时,位于斜齿轮鼓122上的环126将达到斜齿轮鼓122的远端,由此启动反转马达传感器156,该反转马达传感器156向控制单元发送信号,控制单元又向马达106发出信号,使马达106反转。这又导致切割器械34缩回,并导致位于斜齿轮鼓122上的环126向回运动到斜齿轮鼓122的近端。
手柄中部件130包括后侧肩部160,该后侧肩部160与带槽的臂144接合,如在图8和9中最清楚显示的。手柄中部件130还包括前向运动止动件162,其与击发扳机24接合。如上所述,带槽的臂144的运动通过马达106的旋转控制。当带槽的臂144随着环126从斜齿轮鼓122的近端行进到远端而逆时针方向旋转时,手柄中部件130将沿逆时针方向自由旋转。由此,当操作者向内拉动击发扳机24时,击发扳机24将与手柄中部件130的前向运动止动件162接合,从而使手柄中部件130逆时针方向旋转。但是,由于与带槽的臂144接合的后侧肩部160,手柄中部件130将仅能逆时针方向旋转到带槽的臂144允许的程度。这样,如果马达106由于某些原因停止旋转,带槽的臂144将停止旋转,并且操作者将不能进一步向内拉动击发扳机24,因为手柄中部件130由于带槽的臂144而无法自由地逆时针旋转。
图11和12示出了根据本发明的各种实施方式可用作运转马达传感器128的可变传感器的两种状态。传感器128可包括面部164、第一电极(A)166、第二电极(B)168、以及位于电极166和168之间的可压缩电介质材料170(例如EAP)。传感器128可定位成面部164在击发扳机24缩回时与之接触。由此,当击发扳机24缩回时,电介质材料170被压缩,如图12所示,使得电极166和168向一起靠近。因为电极166和168之间的距离“b”与电极166和168之间的阻抗直接相关,该距离越远,阻抗越大,该距离越近,阻抗越小。这样,由于击发扳机24的缩回导致的电介质材料170的压缩(在图12中以力“F”表示)量与电极166和168之间的阻抗成比例。由传感器128提供的阻抗可用于合适的信号调节电路,以便例如对马达106的速度进行比例控制。
在图7至10中还示出了通过缩回闭合扳机22闭合(或夹紧)端部执行器16的钉砧28的示例性闭合系统的组成元件。在示出的实施方式中,闭合系统包括通过销174连接到闭合扳机22的轭形件172,销174插入穿过闭合扳机22和轭形件172二者中的对准的开口。闭合扳机22绕枢销176旋转,该枢销176插入穿过闭合扳机22中的另一个开口,其与销174插入穿过闭合扳机22的位置是偏离开的。因此,闭合扳机22的旋转导致闭合扳机22的上部(轭形件172通过销178连接到闭合扳机22的上部)逆时针旋转。轭形件172的远端通过销178连接到第一闭合支架180。第一闭合支架180连接到第二闭合支架182。闭合支架180、182一起形成一个开口,近侧闭合管72的近端(见图4)置于并保持在该开口中,闭合支架180、182的纵向运动导致近侧闭合管72的纵向运动。器械10还包括设置在近侧闭合管72中的闭合杆184。闭合杆184可包括窗口186,位于手柄外部件之一(例如在所示出的实施方式中为外部下侧件96)上的柱188进入该窗口186,从而将闭合杆184固定地连接到手柄12上。这样,近侧闭合管72能够相对于闭合杆184纵向运动。闭合杆184还可包括远侧卡圈190,该卡圈190被装配入近侧脊管79的腔192中,并由帽194保持在其中(见图4)。
在操作过程中,当轭形件172由于闭合扳机22的缩回而旋转时,闭合支架180、182使近侧闭合管72向远侧运动(即,离开器械10的手柄12),这使得远侧闭合管74向远侧运动,钉砧28绕着枢销42旋转进入夹钳或闭合位置。当闭合扳机22从锁定位置解锁时,使近侧闭合管72向近侧滑动,这导致远侧闭合管74向近侧滑动,借助插入到远侧闭合管74的开口78中的凸片44,使得钉砧28绕着枢销42旋转进入张开或松开位置。这样,通过缩回和锁定闭合扳机22,操作者可夹钳位于钉砧28和通道26之间的组织,并且在切割/缝合操作之后通过使闭合扳机22从锁定位置解锁而松开组织。
控制单元(在下面进一步描述)可接收来自冲程结束和冲程开始传感器156、158以及运转马达传感器128的输出信号,并可基于输入信号控制马达106。例如,当操作人员在锁定闭合扳机22之后开始拉动击发扳机24时,运转马达传感器128被致动。如果控制单元确定未用尽的钉仓38在端部执行器16中存在时,如同下面进一步描述的那样,控制单元可将控制信号输出到马达106,引起马达106沿着向前的方向旋转。当端部执行器16到达其冲程末端时,反向马达传感器156将启动。控制单元可接收来自反向马达传感器156的该输出信号并引起马达106反向。当切割器械34完全回缩时,停止马达传感器开关158被致动,控制单元使马达106停止。
根据各种实施方式,器械10可包括端部执行器16中的转发器。转发器通常可以是任何适于发送指示端部执行器16的一个或多个状态的无线信号的装置。在一些实施方式中,例如,响应于从控制单元接收的无线信号转发器将无线信号传输到控制单元。在这些实施方式中,由控制单元和转发器传输的无线信号分别被称为“询问”和“回答”信号。转发器可与定位在端部执行器16中的一种或多种类型的传感器(例如位置传感器、位移传感器、压力/负载传感器、接近传感器等)通信,以便转换端部执行器的各种状态,例如钉仓38的状态(例如击发或未击发)、钉砧28的各个位置(例如打开或者闭合)和滑块36的位置(例如在近侧或远侧)。确定所述状态的传感器的设置在上述作为参考的未决美国专利申请No.11/343439中描述,其包含于本申请中。根据下面的各种实施方式和讨论,转发器可以是无源装置,其操作动力来自无线信号(例如询问信号)。在其它实施方式中,转发器可以是由设置在端部执行器16中的自备电源(例如电池)提供动力的有源装置。转发器和控制电路可被构造成使用任何合适类型的无线信号通信。根据下面的各种实施方式并且如下讨论的那样,例如,转发器和控制电路可使用由感应效应产生的磁场发送并接收无线信号。应当理解,代替的,转发器和控制电路可使用电磁场(例如RF信号、光信号)或者例如使用由电容效应产生的电场来发送和接收无线信号。还应当理解,端部执行器16可包括另外的转发器,并且每个转发器还具有一个或多个专用传感器,用于将数据输入其中。
图13示出了根据各种实施方式的控制单元196的框图。如图所示,控制单元196可包括处理器198和一个或多个存储器单元200。控制单元196可由包含在器械10中的电池104或者其它合适的电源供电。在一些实施方式中,控制单元196可进一步包括感应元件202(例如线圈或者天线)以从转发器经磁场发送和接收无线信号(例如询问和回答信号)。由感应元件202接收的信号可由解调器204解调并由解码器206解码。通过执行存储在存储器200中的指令代码,处理器198可基于端部执行器传感器的输入信号(如同被解码信号指示的那样)和从其它各种传感器(例如诸如运转马达传感器128、冲程结束和冲程开始传感器156、158)接收的输入信号控制器械10的各种元件,诸如马达106和用户显示器(未显示)。
由控制单元196输出的无线信号可以是由感应元件202发出的交替磁场的形式。控制单元196可包括编码器208和调制器210,编码器208用于对待发送到转发器的数据进行编码,调制器210用于使用任何合适的调制方案根据被编码数据调制磁场。控制单元196可使用任何合适的无线通信协议和任何合适的频率(例如I SM频带或者其它RF频带)与转发器通信。而且,控制单元196可以以与从转发器接收的回答信号的频率范围不同的频率范围发送信号。另外,虽然在图13中仅仅显示一个天线(感应元件202),在其它实施方式中控制单元196可具有单独的接收和发射天线。
根据各种实施方式,控制单元196可包括微控制器、微处理器、现场可编程门阵列(FPGA)、一个或多个其它类型的集成电路(例如RF接收器和PWM控制器)和/或分离的无源元件。控制单元196还可以例如为系统集成芯片(SoC)或者系统级封装(SIP)。
如图14中所示,控制单元196可被容纳在器械10的手柄12中并且转发器212可被定位在端部执行器16中。为了将信号发送到转发器212并从其接收信号,控制单元196的感应元件202与定位在轴14中远离旋转接头19的次级感应元件(例如线圈)214可感应地耦合。次级感应元件214优选与导电轴14电绝缘。
次级感应元件214可通过带绝缘皮的电导线216与定位在端部执行器16附近(优选在关节运动枢轴18远侧定位)的远侧感应元件(例如线圈)218连接。导线216可由导电聚合物和/或金属(例如铜)制成,并可具有足够的柔性,使其能够通过关节运动枢轴18并不被关节运动损坏。远侧感应元件218可感应地与位于例如端部执行器16的钉仓38中的转发器212耦合。转发器212(将在下面详细描述)可包括用于感应耦合到远侧线圈218的天线(或线圈),以及发射并接收无线信号的相关电路。
在一些实施方式中,转发器212可以由远侧感应元件218发出的磁场无源地提供动力。一旦充分地提供动力,转发器212可借助(i)转发器212和远侧感应元件218之间的感应耦合,(ii)导线216,和(iii)次级感应元件214和控制单元196之间的感应耦合来发送和/或接收数据(例如通过调制磁场)到手柄12中的控制单元196。控制单元196可由此与端部执行器16中的转发器212通信而不需要通过复杂的机械接头例如旋转接头19的硬连线的连接,和/或不需要设置在从轴14到端部执行器16的硬连线的连接,可放置在可能难以保持所述连接的地方。另外,由于感应元件之间的距离(例如在(i)转发器212和远侧感应元件218以及(ii)次级感应元件214和控制单元196之间的间隔)是固定且已知的,耦合可被优化以便感应能量传递。而且,该距离可以相对较短,使相对较小的功率信号可被使用,从而使与在器械10的使用环境中的其它系统的干扰最小化。
在图14的实施方式中,控制单元196的感应元件202定位在相对靠近控制单元196的位置。根据各种实施方式,如图15中所示,控制单元196的感应元件202可被定位得更靠近旋转接头19,该旋转接头19更靠近次级感应元件214,由此缩短在这种实施方式中感应耦合的距离。作为替代,控制单元196(因此感应元件202)可被定位得更靠近次级感应元件214以缩短间隔。
在其它实施方式中,可使用多于或者少于两个感应耦合。例如,在一些实施方式中,外科器械10可在手柄12中的控制单元196和端部执行器16中的转发器212之间使用单感应耦合,由此不需要感应元件214、218和导线216。当然,在这样的实施方式中,由于手柄12中的控制单元196和端部执行器16中的转发器212之间的距离更大,需要更强的信号。而且,可使用两个以上感应耦合。例如,如果外科器械10具有许多复杂的机械接头,难以保持硬连线的连接,感应耦合可被用于跨接每个这样的接头。例如,感应耦合可在旋转接头19的两侧上和关节运动枢轴18的两侧上使用,并且旋转接头19的远侧上的感应元件220由导线216与关节运动枢轴的近侧的感应元件218连接,导线222连接关节运动枢轴18的远侧上的感应元件224、226,如图16所示。在该实施方式中,感应元件226可与转发器212通信。
在上述实施方式中,每个感应元件202、214、218、224、226可包括或者不包括铁氧体芯。另外,感应元件214、218、224、226还优选与器械10的导电外轴(或者机架)(例如闭合管72、74)绝缘,并且导线216、222也优选与外轴1 4绝缘。
图17是根据各种实施方式的钉仓38的包括转发器212的部分的仰视图。如图所示,可以在钉仓38的远端使用合适的粘接材料诸如环氧树脂将转发器212保持在或者嵌入钉仓38中。
图18示出了根据各种实施方式的转发器212的电路图。如图所示,转发器212可包括具有感应元件250(例如线圈或者天线)和电容器252的谐振电路249。转发器212可进一步包括与谐振电路249连接的微芯片254。在一些实施方式中,微芯片254例如可以是RFID装置,其包括能够经谐振电路249的感应元件250与控制单元196通信的电路。微芯片254可包括至少一个数据输入,用于接收来自设置在端部执行器16中的传感器235的离散或者模拟信号形式的数据。如上所述,传感器235可包括例如用于感测端部执行器各种状态的位置传感器、位移传感器、压力/负载传感器、接近程度传感器。微芯片254还可包括一个或多个动态存储装置255(例如闪存装置)以便存储例如由控制单元196发送的数据。微芯片254还可包括一个或多个非动态存储装置257(例如即写存储装置)以便存储静态数据例如诸如钉仓识别数目,生产商信息和与钉仓38的物理特性相关的信息。
响应于由远侧感应元件218发出的交替磁场,使转发器212的谐振电路249谐振,由此引起交替输入电压被施加到微芯片254。谐振电路249可具有由 给出的谐振频率,其中L1是感应元件250的感应系数值,C1是电容器252的电容值。L1和C1的值可被选择为使电路249的谐振频率等于或者几乎等于由远侧感应元件218发射的磁场的频率。微芯片254的电路可包括整流和调节交流输入电压的整流电路(未显示)以提供足以为微芯片254供电的DC电压。一旦供能,微芯片254可基于从传感器235接收的数据和存储在存储装置255、257中的数据选择性加载感应元件250,从而调制耦合远侧感应元件218和感应元件250的磁场。磁场的调制能够调制通过远侧感应元件218的电压,进而调制通过控制单元196的感应元件202的电压。控制单元196可解调并解码通过感应元件202的电压信号,以提取由微芯片254通信的数据。其中,控制单元196可处理该数据以验证钉仓38与器械10兼容并且端部执行器的状态适于进行击发操作。在验证数据之后,控制单元196可进行击发操作。
根据各种实施方式,谐振电路249还可包括与感应元件250串联的保险丝256。当保险丝256接通(例如导电)时,感应元件250与谐振电路249电耦合,从而使转发器212响应于由远侧感应元件218发出的交替磁场起到上述作用。保险丝256的接通状态由此与转发器212的激活(enabled)状态对应。当保险丝256断开(例如不导电)时,感应元件250与谐振电路249电断开,由此防止谐振电路249产生操作微芯片254必需的电压。保险丝256的断开状态由此对应于转发器212的禁止状态。图18中的保险丝256的设置仅作为例子显示,应当理解,保险丝256可以任何方式连接,只要当保险丝256断开时使转发器212被禁止。
根据各种实施方式,保险丝256可大体上与器械10的击发操作同时启动(例如从接通到断开的转变)。例如,保险丝256可恰在击发操作之前、击发操作过程中或者恰在击发操作之后被启动。保险丝256的启动由此将转发器212从激活状态转变成禁止状态。因此,如果试图再次使用钉仓38,转发器212将不能响应于由远侧感应元件218传输的无线信号传输数据。由于数据不存在,控制单元196可确定转发器212处于指示钉仓38的击发状态的禁止状态并防止进行击发操作。因此,当钉仓38处于击发状态时,保险丝256的启动防止了钉仓38的再次使用。
在一些实施方式中,保险丝256可以是机械方式启动的保险丝,例如当被启动后其响应于切割器械34的运动而断开。如图19所示,例如,保险丝256可包括一段横向延伸穿过钉仓38的纵槽258的导线,在击发操作期间切割器械34穿过该纵槽258。当器械10被击发时,切割器械34的远侧运动切断保险丝256,由此将转发器212转变成禁止状态,使钉仓38不能再次被使用。
根据其它实施方式,保险丝256可以是电启动保险丝。例如,在从转发器212接收数据并验证端部执行器16处于待击发状态之后,控制单元196可将无线信号发送到转发器212,使经过保险丝256的最终电流足以引起保险丝256断开。应当理解,断开保险丝256所需的无线信号的强度在振幅、频率和持续时间方面可以不同于用于与转发器212通信的无线信号。另外,应当理解,其它电启动元件可代替电启动保险丝使用以禁止转发器212。例如,控制单元196可将无线信号发送到转发器212,使经过谐振电路256的最终电压足够超过电容器252和/或微芯片254的电路的额定电压,以使它们毁坏。
作为使用电启动保险丝的替代,保险丝256可以是热启动保险丝(例如热熔断保险丝),其响应于由经过其中的过量电流产生的热而断开。
在一些情况下,当钉仓38处于击发状态时需要与转发器212通信。在这些情况下,不可能如在上述实施方式中所述的那样完全禁止转发器212。图20示出了根据各种实施方式的转发器212的电路图,当钉仓38处于击发状态时其用于与控制单元196进行无线通信。如图所示,转发器212的谐振电路249可包括与电容器252并联的第二电容器260。保险丝256可与第二电容器260串联,使谐振电路249的谐振频率由保险丝256的断开/接通状态确定。特别是,当保险丝256接通时,谐振频率由 给出,其中C2是第二电容器260的电容量值。保险丝256的接通状态因此对应于转发器212的第一谐振状态。当保险丝256断开时,谐振频率由 给出。保险丝256的断开状态因此对应于转发器212的第二谐振状态。如上述实施方式描述的那样,保险丝256可与击发操作大致同时地机械、电或者热启动。控制单元196可被构造成通过区分两种谐振频率来确定转发器212的谐振状态(并由此确定钉仓38的击发和未击发状态)。有利地,由于谐振电路256(由此微芯片254)在保险丝256断开后继续操作,控制单元196可继续从转发器212接收数据。应当理解,用于改变谐振频率的保险丝256的设置和第二电容器260的使用仅仅作为例子提供。在其它实施方式中,例如,保险丝256可被连接成,当保险丝256断开时使感应元件250的感应系数值改变(例如当保险丝256接通时通过连接保险丝256使一部分感应元件250短路)。
根据各种实施方式,开关可被用于代替保险丝256来实现转发器状态之间的转变。例如,如图21中所示,钉仓38的钉仓托架68可包括定位在其近端的开关262(例如常断限制开关)。开关262可被安装成当滑块36处于未击发位置中时,滑块36保持开关262处于接通(例如导电)状态。在击发操作过程中当滑块36从未击发位置被驱动到击发位置时,开关262转变为断开(例如不导电状态),由此使转发器212的状态转变,如上所述。应当理解,在其它实施方式中开关262可以是安装在钉仓托架68的远端处的常通开关,当滑块36存在于击发位置中时使开关262断开。还应理解,开关262可被定位在钉仓38的近端或者远端,并被安装成当分别存在于未击发和击发位置中时其可由滑块36适当启动。
作为连接机械启动的保险丝256或者开关262用于禁止/改变谐振电路249的替代,这些元件可被连接到微芯片254的数据输入。这样,机械启动的保险丝256或者开关262的断开/接通状态可以与响应于端部执行器其它状态的数据相同的方式被发送到控制单元196。
作为保险丝256和开关262的替代,本发明的实施方式可代替地利用转发器212的动态存储装置255中的可改变数据值。例如,动态存储装置255可存储与转发器212的第一数据状态对应的第一数据值(例如具有值为1的数据位)。例如,在钉仓38的制造过程中第一数据值可被写入动态存储装置255。第一数据状态可因此作为钉仓38的未击发状态的指示。基于转发器212的第一数据状态的确定,如果端部执行器状态适于进行击发操作,控制单元196可使器械10能够操作。大体上与击发操作同时,控制单元196可将无线信号发送到含有第二数据值(例如具有值为0的数据位)的转发器212。第二数据值可被存储在动态存储装置255中,使第一数据值被覆盖,由此将转发器212从第一数据状态转变成第二数据状态。第二数据状态可由此作为钉仓38的击发状态的指示。如果试图再次使用钉仓38,控制单元196可确定转发器212处于第二数据状态并防止击发操作进行。
虽然上述实施方式中的转发器212包括微芯片254,用于存储在存储装置235、237中的数据和从传感器235输入的数据的无线通信,在其它实施方式中转发器可不包括微芯片254。例如,图22示出了谐振电路形式的“无芯片”转发器264,具有类似于谐振电路249的元件,诸如感应元件250、电容器252和保险丝256。另外,转发器264可包括一个或多个与元件250、252、256串联的传感器235。在一些实施方式中并如图所示,每个传感器235可以是安装在端部执行器16中的限制开关(例如常断或者常通的限制开关)以便感测对应的端部执行器状态(例如钉砧28的位置、滑块36的位置等)。在这些实施方式中,当被感测状态与击发操作兼容时,每个限制开关235可处于接通状态(例如导电),从而通过谐振电路建立电连续。
当每个开关235和保险丝256处于接通状态时,谐振电路可被引起响应于由远侧感应元件218发出的磁场的频率fr发生谐振。保险丝256和开关235的接通状态因此对应于转发器264的激活状态,除了别的以外,其作为钉仓38的未击发状态的指示。控制单元196可感测谐振(例如通过感测由谐振电路引起的磁场加载)以确定激活状态,此时控制电路196可使器械10进行操作。大体上与切割器械34的致动同时,保险丝256可如上所述地机械、电或者热启动,由此将转发器264转变成指示钉仓38的击发状态的禁止状态。如果随后试图进行击发操作而没有替换钉仓38,控制单元196可根据响应于所发出磁场感测的谐振的不存在来确定禁止状态,在这种情况下控制单元196防止击发操作被执行。
图23示出了谐振电路形式的无芯片转发器264,其包括感应元件250、第一电容器252、第二电容器260以及与第二电容器260串联的保险丝256。保险丝256可与击发操作大体上同时机械、电或者热启动,如上所述。转发器264可另外包括一个或多个与谐振电路的第三电容器266串联的传感器235(例如限制开关)。因此,当每个开关235和保险丝256处于接通状态时,可使谐振电路响应于由远侧感应元件218发出的磁场以频率 谐振。当其中一个开关235断开并且保险丝256接通时,谐振频率将为 当每个开关235接通并且保险丝256断开时,谐振频率将为 当开关235和保险丝256都断开时,谐振频率将为 保险丝256和开关235的接通状态对应于转发器264的第一谐振状态(例如谐振频率fr1),保险丝256的断开状态对应于第二谐振状态(例如谐振频率fr3或者fr4)。电容量值C1、C2和C3可被选择成使谐振频率fr1、fr2、fr3和fr4不同。控制单元196可被构造成识别谐振频率的不同以确定转发器266的第一或者第二状态(并由此确定钉仓38的未击发或者击发状态),并相应地允许或者防止器械10的操作。控制单元196可进一步被构造成确定转发器264的与保险丝256的接通状态和任何开关235的断开状态相应的第三状态。在这种情况下,控制单元196可操作以防止击发操作直到引起断开开关235的端部执行器状态消除。
图24是防止在外科器械中钉仓的再次使用的方法的流程图,其可与上面描述的器械10的实施方式结合进行。在步骤300,第一无线信号被发送到转发器212、264。在步骤305,从转发器212、264接收第二无线信号,从而可根据第二无线信号来确定转发器212、264的第一电子态和第二电子态中的一个。在一些实施方式中并如上所述,无线信号可以是由感应效应产生的磁信号,但是也可替代地采用电场和电磁场。转发器212、264的状态是钉仓38的状态的指示。在一些实施方式中,例如,第一和第二转发器状态可分别指示钉仓38的未击发和击发状态。
在步骤310,如果第一电子态(未击发钉仓状态的指示)被确定,切割器械34可在步骤315处被激活。在器械10被激发后,当准备好时操作人员开始击发操作。
在步骤320,转发器212、264可与切割器械34的致动大体上同时从第一电子态转变成第二电子态。因此,如果在步骤300试图再次使用钉仓38,转发器212、264的第二电子态(击发钉仓状态的指示)可在步骤310被确定并且因此防止击发操作,如步骤325所示。
当用尽的钉仓38(或者没有钉仓38)存在于端部执行器16中时,上述实施方式有利地防止了器械10的操作,由此防止切割组织而不同时缝合。除了在所述环境下防止器械10的操作之外,还需要在已经被使用预定数目的击发操作之后防止器械10的操作。限制击发操作的数目是必要的,例如,器械10的使用不引起超过其各种元件(例如切割器械34、电池104等)的使用寿命。
根据各种实施方式,击发操作的数目方面的限制可由控制单元196执行,例如使用包含在处理器198中的计数器(未显示)。对于由控制单元196接收的一个或多个传感器输入(例如从冲程结束和冲程开始传感器156、158和运转马达传感器128接收的输入)指示的每次击发操作计数器增加一次。在每次击发操作之后,处理器198可将计数器内容与预定数目比较。预定数目例如可在制造过程中被存储在处理器198的存储器200中,并代表可由器械10执行的击发操作的最大数目。其中,预定数目可根据器械的各个元件的使用寿命和/或器械10被使用的医疗手术的预期要求来确定。当计数的击发操作数目等于预定数目时,控制单元196可被设置成防止由器械10进行的另外击发操作。在其中控制单元196直接或者间接控制马达106的旋转(例如借助响应于来自运行马达传感器128的输入的PWM信号输出)的实施方式中,存储在存储器200中的指令代码可引起处理器198防止马达运行所需的动力和/或控制信号的进一步输出。
在其它实施方式中,控制单元196可通过禁止马达运转所需的电子元件来防止击发操作超过预定数目。例如,如图25中所示,控制单元196可经多根导线268与马达106连接,其中一根导线包括电启动保险丝270。在最终击发操作(例如当击发操作数目等于预定数目时)之后切割器械34缩回后,控制单元196可引起施加到马达106的电流增加,使保险丝270断开(例如致使不导电),由此防止进一步的马达运转。应当理解,保险丝270的设置仅仅作为例子显示,并且保险丝270可以其它方式连接以产生相同的结果。例如,保险丝270可连接在电池104和器械10的电子元件之间。在所述实施方式中,当击发操作的数目等于预定数目时,控制单元196可使保险丝270短路,使其被断开,从而从电子元件上除去电力。
作为保险丝270的替代,应当理解,可由控制单元196的离散输出控制的开关(例如继电器触点)可作为替代被使用。另外,应当理解,控制单元196可被构造成通过将过量电压和/或电流施加于马达运转(例如电容器、晶体三极管等)所需的一个或多个元件上(不同于保险丝)而电禁止所述元件。所述元件可置于控制单元196的内部或者外部。
虽然限制器械使用的上述实施方式采用位于处理器198中的计数器,但是应当理解,其它实施方式也可使用机电计数器,其具有适当耦合到器械10的元件(例如击发扳机24)的机械输入,使计数器对于每次击发操作都增加一次。计数器可包括当计数的击发操作数目超过存储在计数器中的预定数目时接通(或者断开)的一组电触头。触头可用作对控制单元196的输入,并且处理器198可被编程以基于触头的状态允许或者禁止器械操作。作为替代,触头可与器械的其它元件(例如电池104或者马达106)连接,当超过计数的预定数目时使到马达106的电力中断。
在上述实施方式中,电池104为器械10的击发操作供电(至少部分)。这样,器械可以是所谓的“动力辅助”装置。动力辅助装置的更多细节和其它实施方式在上面参考的未决美国专利申请No.11/343573中描述,其包含在本申请中。但是,应当认识到,器械10不必是动力辅助的装置,其仅仅是可利用本发明各方面的装置类型的例子。例如,器械10可包括由电池104供电并由控制单元196控制的用户显示器(诸如LCD或者LED显示器)。来自端部执行器16中的转发器212和264的数据可显示在这样的显示器上。
在另一种实施方式中,器械10的轴14,包括例如近侧闭合管72和远侧闭合管74,可通过发送信号到转发器212、264并从转发器212、264接收发射的信号而一起用作用于控制单元196的天线的一部分。这样,到达和来自端部执行器16中的转发器212、264的信号可借助器械10的轴14被发送。
近侧闭合管72可通过可由不导电材料诸如塑料制成的外部下侧件96和外部上侧件98在其近端接地。在近侧和远侧闭合管72、74内部的驱动轴组件的元件(包括主驱动轴80和次驱动轴82)也可由不导电材料诸如塑料制成。此外,端部执行器16的元件(诸如钉砧28和通道26)可电连接到(或者直接或间接电接触)远侧闭合管74,使它们也作为天线的一部分。此外,转发器212、264可被定位成使其与用作天线的轴14和端部执行器16的元件电绝缘。例如,如上所述,转发器212、264可被定位在可由不导电材料诸如塑料制成的钉仓38中。由于用作天线的轴14的远端(诸如远侧闭合管74的远端)和部分端部执行器16可与转发器212、264在距离上相对接近,用于发送信号的电力可被控制,使得与在器械10的使用环境中的其它系统的干扰被降低或者最小化。
在这样的实施方式中,如图22所示,控制单元196可通过导电连接件272(例如导线)与器械10的轴14电连接,诸如连接到近侧闭合管72。部分外轴14、诸如闭合管72、74可因此通过发送信号到转发器212、264并接收由转发器212、264发送的信号而作为用于控制单元196的天线的一部分。由控制单元196接收的信号可由解调器204解调并由解码器206解码,如上所述。
为了将数据信号传送到端部执行器16中的转发器212、264或者从其接收信号,连接件272可将控制单元196连接到器械10的轴14的元件诸如可电连接到远侧闭合管74的近侧闭合管72。远侧闭合管74优选与可被定位在塑料钉仓38中的转发器212、264电绝缘。如前所述,端部执行器16的元件诸如通道26和钉砧28可以是导电的并可与远侧闭合管74电接触,使它们也能作为天线的一部分。
在轴14作为用于控制单元196的天线的条件下,控制单元196可与端部执行器16中的转发器212、264通信而不需要硬件连接。另外,由于轴14和转发器212、264之间的距离是固定并已知的,动力水平可被优化从而使其与器械10的使用环境中的其它系统的干扰最小化。
在另一种实施方式中,轴14和/或端部执行器16的元件可用作用于转发器212、264的天线。在这样的实施方式中,转发器212、264与轴14(诸如远侧闭合管74,其可与近侧闭合管72电连接)电连接,并且控制单元196与轴14绝缘。例如,转发器212、264可与端部执行器16的导电元件(诸如通道26)连接,所述导电元件又可与轴的导电元件(诸如闭合管72、74)连接。作为替代,端部执行器16可包括连接转发器212、264和远侧闭合管74的导线(未显示)。
上面已经结合切割型外科器械描述了本发明的各种实施方式。但应当注意的是,在其它实施方式中,在本申请中公开的发明的外科器械不必是切割型外科器械,而是能够在包括传感器转发器的任何类型的外科器械中使用。例如,它可以是非切割型内镜器械、抓钳、缝合器、夹施放器、进入装置、药物/基因治疗输送装置,使用超声、RF、激光等的能量装置。另外,本发明可以是例如腹腔镜器械。本发明还具有在传统内窥镜和开放式外科器械以及机器人辅助的外科手术方面的应用。
在本文中公开的装置可被设计成单次使用后可抛弃的,或者它们可被设计成多次使用的。但在任一种情况下,装置可被重新调节以便在至少一个使用之后再次使用。重新调节可包括装置拆卸步骤的任何组合,接着清洗或者替换特殊部件,随后组装。特别是,装置可被拆卸,并且任何数目的特殊部件或者装置的部分可选择性地以任何组合被替换或者除去。当清洁和/或替换特殊部件时,装置可在重新调节车间或者在外科手术之前由外科团队随即重新组装用于随后的使用。本领域技术人员将会理解,装置的重新调节可利用用于拆卸、清洁/替换和重新组装的各种技术,所述技术的使用和产生的调节装置都在本发明的范围内。
在本文中已经结合一些公开的实施方式对本发明进行了描述,对这些实施方式的任何修改和变化可被执行。例如,不同类型的端部执行器可被采用。而且,材料被公开用于一些元件,其它材料也可被使用。前述描述和下面的权利要求书将覆盖所有这些修改和变化。
声称通过引用被包含在本申请的任何专利、出版物或者其它公开材料,全部或部分,仅仅包含到所包含的材料不与现有定义、表述或者在该公开文本中阐明的其它公开材料相冲突的程度。如此以来,并到必要的程度,在本文中明确阐明的公开内容取代任何通过引用包含在本文中的相冲突的材料。声称通过引用包含在本申请中但与现有定义、表述或者其它公开材料相冲突的任何材料或者其部分仅仅被包含到不引起包含的材料与现有公开材料之间的冲突的程度。
Claims (10)
1.一种外科器械,包括:
具有转发器的钉仓;和
控制单元,用于将第一无线信号发送到所述转发器并从所述转发器接收第二无线信号,以便根据所述第二无线信号确定所述转发器的第一电子态和第二电子态中的一个。
2.根据权利要求1所述的外科器械,其中,所述第一电子态是钉仓未击发状态的指示,并且所述第二电子态是钉仓击发状态的指示。
3.根据权利要求2所述的外科器械,还包括端部执行器,所述端部执行器包括:
钉仓,其中所述钉仓包括设置在其中的滑块;
用于切割物体的机电致动的切割器械,其中所述切割器械的致动由所述控制单元控制;
纵向延伸的通道,用于以可拆卸的方式安放钉仓;和
与所述通道以可枢转的方式连接的钉砧,其中所述物体被定位在所述钉砧和所述通道之间;
其中,当所述切割器械被致动时,所述滑块由所述切割器械接合并被从位于所述钉仓近端的未击发位置纵向驱动经过所述钉仓到达位于所述钉仓远端的击发位置,所述滑块的未击发位置与所述钉仓的未击发状态对应,所述滑块的击发位置与所述钉仓的击发状态对应。
4.根据权利要求3所述的外科器械,其中,当确定为第一电子态时,所述控制单元允许所述切割器械的致动,当确定为第二电子态时,所述控制单元防止所述切割器械的致动。
5.根据权利要求4所述的外科器械,其中,与所述切割器械的致动基本上同时,所述控制单元将第三无线信号发送到所述转发器。
6.根据权利要求5所述的外科器械,其中,所述转发器包括至少一个元件,其由所述转发器响应于所述第三无线信号而电子地改变,从而使所述转发器从第一电子态转变到第二电子态。
7.根据权利要求6所述的外科器械,其中,每个所述至少一个元件选自如下的组,所述组包括电启动保险丝、热启动保险丝、电容器和存储装置。
8.根据权利要求4所述的外科器械,其中,所述转发器包括至少一个元件,其响应于所述切割器械受致动时的运动而电子地改变,被改变的所述至少一个元件使所述转发器从第一电子态转变到第二电子态。
9.根据权利要求8所述的外科器械,其中,每个所述至少一个元件选自如下的组,所述组包括机械启动保险丝和开关。
10.一种用于外科器械的钉仓,所述钉仓包括能够从第一电子态转变到第二电子态的转发器,其中所述第一电子态是所述钉仓未击发状态的指示,所述第二电子态是所述钉仓击发状态的指示。
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CN114144138A (zh) * | 2019-06-28 | 2022-03-04 | 西拉格国际有限公司 | 包括对准的rfid传感器的外科器械 |
CN114126502B (zh) * | 2019-06-28 | 2024-03-08 | 西拉格国际有限公司 | 用于外科缝合系统的可替换部件的包装 |
CN114145796A (zh) * | 2021-09-27 | 2022-03-08 | 元创医学技术(江苏)有限公司 | 一种防二次击发的腔镜直线切割闭合器 |
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US20080164296A1 (en) | 2008-07-10 |
EP1943956A2 (en) | 2008-07-16 |
US7721931B2 (en) | 2010-05-25 |
JP5220425B2 (ja) | 2013-06-26 |
HK1118193A1 (en) | 2009-02-06 |
CN101224116B (zh) | 2012-09-05 |
ATE555729T1 (de) | 2012-05-15 |
EP1943956B1 (en) | 2012-05-02 |
JP2008212638A (ja) | 2008-09-18 |
EP1943956A3 (en) | 2008-09-24 |
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