CN103384501A - 访问存储在外科器械存储器中的数据 - Google Patents

访问存储在外科器械存储器中的数据 Download PDF

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CN103384501A
CN103384501A CN2012800100418A CN201280010041A CN103384501A CN 103384501 A CN103384501 A CN 103384501A CN 2012800100418 A CN2012800100418 A CN 2012800100418A CN 201280010041 A CN201280010041 A CN 201280010041A CN 103384501 A CN103384501 A CN 103384501A
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trigger
sensor
motor
percussion
end effector
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F·E·谢尔顿四世
J·R·乔达诺
J·S·斯韦兹
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Ethicon Endo Surgery Inc
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Abstract

本发明公开了一种方法和系统,所述方法和系统用于将存储在外科切割和紧固器械(10)的存储装置中的传感器数据下载到外部的或远程计算机装置(2420)。所述方法可包括在涉及外科切割和紧固器械的外科手术期间,将来自外科切割和紧固器械的一个或多个传感器的数据存储到外科切割和紧固器械的控制单元(2400)的存储装置(2406)中。接着,在外科手术之后,数据链路(2422)在控制单元和远程计算机装置之间建立。随后,传感器数据可从控制单元被下载到远程计算机装置。

Description

访问存储在外科器械存储器中的数据
优先权声明
本专利申请是2008年9月23日由Shelton等人提交的名称为“Accessing Data Stored In A Memory of A Surgical Instrument”的美国专利申请12/236,277的部分继续申请,并且要求2006年1月31日由Shelton等人提交的名称为“Surgical Instrument Having Recording Capabilities”的序列号11/343,803的优先权,该专利申请全文以引用的方式并入本文。
相关专利申请的交叉引用
本专利申请涉及以下美国专利申请,其与前面段落引用的美国专利申请序列号11/343,803同时提交,并且全文以引用的方式并入本文。
(1)MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH USER FEEDBACK SYSTEM,由FrederickE.Shelton,IV、John Ouwerkerk和Jerome R.Morgan提交,序列号为11/343,498;
(2)MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH LOADING FORCE FEEDBACK,由Frederick E.Shelton,IV、John N.Ouwerkerk、Jerome R.Morgan和Jeffrey S.Swayze提交,序列号为11/343,573;
(3)MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH TACTILE POSITION FEEDBACK,由Frederick E.Shelton,IV、John N.Ouwerkerk、Jerome R.Morgan和Jeffrey S.Swayze提交,序列号为11/344,035;
(4)MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH ADAPTIVE USER FEEDBACK,由Frederick E.Shelton,IV、John N.Ouwerkerk和Jerome R.Morgan提交,序列号为11/343,447;
(5)MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH ARTICULATABLE END EFFECTOR,由Frederick E.Shelton,IV和Christoph L.Gillum提交,序列号为11/343,562;
(6)MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH MECHANICAL CLOSURE SYSTEM,由Frederick E.Shelton,IV和Christoph L.Gillum提交,序列号为11/344,024;
(7)SURGICAL CUTTING AND FASTENING INSTRUMENT WITHCLOSURE TRIGGER LOCKING MECHANISM,由Frederick E.Shelton,IV和Kevin R.Doll提交,序列号为11/343,321;
(8)GEARING SELECTOR FOR A POWERED SURGICAL CUTTINGAND FASTENING STAPLING INSTRUMENT,由Frederick E.Shelton,IV、Jeffrey S.Swayze、Eugene L.Timperman提交,序列号为11/343,563;
(9)SURGICAL INSTRUMENT HAVING A REMOVABLEBATTERY,由Frederick E.Shelton,IV、Kevin R.Doll、Jeffrey S.Swayze和Eugene Timperman提交,序列号为11/344,020;
(10)ELECTRONIC LOCKOUTS AND SURGICAL INSTRUMENTINCLUDING SAME,由Jeffrey S.Swayze、Frederick E.Shelton,IV和Kevin R.Doll提交,序列号为11/343,439;
(11)ENDOSCOPIC SURGICAL INSTRUMENT WITH A HANDLETHAT CAN ARTICULATE WITH RESPECT TO THE SHAFT,由Frederick E.Shelton,IV、Jeffrey S.Swayze、Mark S.Ortiz和Leslie M.Fugikawa提交,序列号为11/343,547;
(12)ELECTRO-MECHANICAL SURGICAL CUTTING ANDFASTENING INSTRUMENT HAVING A ROTARY FIRING ANDCLOSURE SYSTEM WITH PARALLEL CLOSURE AND ANVILALIGNMENT COMPONENTS,由Frederick E.Shelton,IV、Stephen J.Balek和Eugene L.Timperman提交,序列号为11/344,021;
(13)DISPOSABLE STAPLE CARTRIDGE HAVING AN ANVIL WITHTISSUE LOCATOR FOR USE WITH A SURGICAL CUTTINGAND FASTENING INSTRUMENT AND MODULAR ENDEFFECTOR SYSTEM THEREFOR,由Frederick E.Shelton,IV、Michael S.Cropper、Joshua M.Broehl、Ryan S.Crisp、Jamison J.Float和Eugene L.Timperman提交,序列号为11/343,546;和
(14)SURGICAL INSTRUMENT HAVING A FEEDBACK SYSTEM,由Frederick E.Shelton,IV、Jerome R.Morgan、Kevin R.Doll、Jeffrey S.Swayze和Eugene Timperman提交,序列号为11/343,545。
背景技术
本发明一般涉及外科器械,并且具体地涉及能够记录器械的各种状态的微创外科器械。
内窥镜式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减少术后恢复时间和并发症。因此,已对适于将远侧端部执行器穿过套管针的插管精确地放置在所需手术部位处的一系列内窥镜式外科器械进行了显著的开发。这些远侧端部执行器以多种方式接合组织以实现诊断或治疗效果(例如直线切割器、抓紧器、切割器、缝合器、施夹器、进入装置、药物/基因治疗递送装置以及利用超声波、射频、激光等的能量装置)。
已知的外科缝合器包括端部执行器,所述端部执行器在组织中形成纵向切口,同时在切口的相对侧上施加成排的缝钉。端部执行器包括一对协同工作的钳口构件,如果要将所述器械用于内窥镜式或腹腔镜式应用,则所述钳口构件能够穿过插管通道。钳口构件中的一个容纳钉仓,该钉仓具有横向间隔开的至少两行缝钉。另一钳口构件限定砧座,所述砧座具有与仓中的成行的缝钉对齐的缝钉成形凹坑。器械包括多个往复式楔形件。当朝远侧驱动时,所述多个往复式楔形件穿过钉仓中的开口并且与支撑缝钉的驱动器接合,以使得缝钉朝着砧座击发。
适于内窥镜式应用的外科缝合器的例子在授予Knodel等人的名称为“SURGICAL STAPLER INSTRUMENT”的美国专利5,465,895中有所描述,该专利公开了具有独特的闭合和击发动作的直线切割器。利用此装置的临床医生能够在组织上闭合钳口构件,以在击发之前定位组织。一旦临床医生已确定钳口构件正确地夹住了组织,临床医生然后可根据装置使用单击发冲程或多击发冲程来击发外科缝合器。击发外科缝合器使组织被切断及缝合。同时的切断和缝合避免了当使用分别仅进行切断和缝合的不同外科工具依次执行这些动作时可能产生的并发症。
在击发前能够在组织上闭合的一个具体优点是,临床医生能够经由内窥镜检查是否达到理想的切割位置,包括是否已在相对的钳口之间捕获足量的组织。否则,相对的钳口可能被牵拉得太近,特别是在它们的远端处夹拢,并且因此不能在切断的组织内有效形成闭合缝钉。另一个极端情况是,被夹持的过量组织可导致束缚和不完全击发。
当内窥镜式外科器械失效时,其常被返送回制造商或其它单位进行失效分析。如果失效导致了器械的严重级别的缺陷,则制造商必须确定失效的原因并且确定是否需要改变设计。在那种情况下,制造商可能花费上百个工时来分析失效器械,并且试图仅根据对器械造成的损坏来重新构建器械失效的条件。以此种方式分析器械失效可为昂贵且非常具有挑战性的。而且,这些分析中的许多仅仅推断出由于对器械的不当使用造成的失效。
发明内容
在一个总体方面,本发明涉及用于将存储在外科切割和紧固器械的存储装置中的传感器数据下载到外部或远程计算机装置的方法和系统。根据多个实施例,所述方法包括在涉及外科切割和紧固器械的外科手术期间,将来自外科切割和紧固器械的一个或多个传感器的数据存储在外科切割和紧固器械的控制单元的存储装置中。接着,在外科手术之后,在控制单元和远程计算机装置之间建立了数据链路。然后,传感器数据可从控制单元被下载到远程计算机装置。传感器可包括,例如:闭合触发器传感器,其感测闭合触发器的致动;砧座闭合负荷传感器,其感测当砧座闭合时由砧座产生的钉仓上的负荷;击发触发器传感器,其用于感测击发触发器的致动;刀位置传感器,其用于感测端部执行器中的刀的位置;仓存在传感器,其用于检测仓是否存在于端部执行器中;仓条件传感器,其用于检测仓的条件;以及铰接传感器,其用于检测端部执行器的铰接。
附图说明
本文以举例的方式结合以下附图来描述本发明的各种实施例,其中:
图1和2为根据本发明的各种实施例的外科切割和紧固器械的透视图;
图3-5为根据本发明的各种实施例的器械的端部执行器和轴的分解图;
图6为根据本发明的各种实施例的端部执行器的侧视图;
图7为根据本发明的各种实施例的器械的柄部的分解图;
图8和9为根据本发明的各种实施例的柄部的局部透视图;
图10为根据本发明的各种实施例的柄部的侧视图;
图10A和10B示出了根据本发明的各种实施例的可被使用的比例传感器;
图11为根据本发明的各种实施例的用于器械中的电路的示意图;
图12-13为根据本发明的其它实施例的柄部的侧视图;
图14-22示出了根据本发明的各种实施例的用于锁定闭合触发器的不同机构;
图23A-B示出了根据本发明的各种实施例的可用于器械的铰接点处的万向接头(“u-joint”);
图24A-B示出了根据本发明的各种实施例的可用于器械的铰接点处的扭力缆线;
图25-31示出了根据本发明的另一个实施例的具有动力辅助的外科切割和紧固器械;
图32-36示出了根据本发明的另一个实施例的具有动力辅助的外科切割和紧固器械;
图37-40示出了根据本发明实施例的具有触觉反馈的外科切割和紧固器械;
图41示出了根据本发明的各种实施例的器械的端部执行器和轴的分解图;
图42示出了根据本发明的各种实施例的机械器械的柄部的侧视图;
图43为图42的机械致动的器械的柄部的分解图;
图44示出了根据本发明的各种实施例的用于记录器械的各种状态的记录系统的方框图;
图45-46示出了根据本发明的各种实施例的器械的柄部的剖面侧视图,该器械示出了各种传感器;
图47示出了根据本发明的各种实施例的器械的端部执行器,该器械示出了各种传感器;
图48示出了根据本发明的各种实施例的器械的击发杆,该器械包括传感器;
图49示出了根据本发明的各种实施例的器械的柄部、端部执行器和击发杆的侧视图,该器械示出了传感器;
图50示出了根据本发明的各种实施例的器械的钉槽和钉仓各部分的分解图,该器械示出了各种传感器;
图51示出了根据本发明的各种实施例的器械的钉槽的自上而下视图,该器械示出了各种传感器;
图52A和52B示出了根据各种实施例的流程图,该流程图示出了操作器械的方法;
图53示出了根据本发明的各种实施例的内存图表,该内存图表示出了器械的示例性的记录的条件;
图54为根据本发明的实施例的记录系统的方框图,该记录系统用于记录器械的各种条件;
图55为示出了与远程计算机装置连通的外科器械的图表;并且
图56为根据本发明的各种实施例的绘出了流程的流程图。
具体实施方式
图1和图2示出了根据本发明各种实施例的外科切割和紧固器械10。图示实施例是内窥镜式外科器械10,通常本申请描述的器械10的实施例是内窥镜式外科切割和紧固器械。然而,应该指出的是,根据本发明的其它实施例,器械10可为非内窥镜式外科切割器械,例如腹腔镜式器械。
图1和图2示出的外科器械10包括柄部6、轴8和在铰接枢轴14处枢转地连接至轴8的铰接连接的端部执行器12。铰接控制器16可被设置成与柄部6相邻,以使端部执行器12绕铰接枢轴14旋转。应当理解,各种实施例可包括非枢转的端部执行器,因此可能不具有铰接枢轴14或铰接控制器16。此外,在图示的实施例中,端部执行器12能够充当用于夹持、切断和缝合组织的直线切割器,虽然在其它实施例中可采用不同类型的端部执行器,如用于其它类型的外科器械的端部执行器,例如抓紧器、切割器、缝合器、施夹器、进入装置、药物/基因治疗装置,超声波、射频或激光装置等。
器械10的柄部6可包括用于致动端部执行器12的闭合触发器18和击发触发器20。应当理解,具有涉及不同手术任务的端部执行器的器械可具有用于操纵端部执行器12的不同数量或类型的触发器或者其它合适的控制器。端部执行器12被显示为优选地通过细长轴8与柄部6分开。在一个实施例中,临床医生或器械10的操作者可通过利用铰接控制器16相对于轴8来铰接端部执行器12,如在由Geoffrey C.Hueil等人于2006年1月10日提交的名称为“Surgical Instrument Having An Articulating End Effector”的未决美国专利申请序列号11/329,020中所详细描述地那样,该专利申请全文以引用的方式并入本文。
在该实例中,除了别的以外,端部执行器12还包括钉槽22和枢转地平移的夹持构件,例如砧座24,其以确保有效地缝合和切断夹持在端部执行器12中的组织的间隔来保持。柄部6包括手枪式握把26,由临床医生将闭合触发器18枢转地拉向手枪式握把26,以使砧座24朝着端部执行器12的钉槽22夹持或闭合,从而夹持住定位在砧座24和槽22之间的组织。击发触发器20在闭合触发器18的更外侧。如以下进一步描述的,一旦闭合触发器18被锁定在闭合位置,击发触发器20即可朝向手枪式握把26略微旋转,以使得其可由操作者单手触及。然后,操作者可将击发触发器20枢转地拉向手枪式握把26以缝合和切断夹持在端部执行器12中的组织。在其它实施例中,可使用除砧座24之外的不同类型的夹持构件,例如相对的钳口等。
应当理解,本文使用的术语“近侧”和“远侧”是相对于抓持器械10的柄部6的临床医生而言的。因此,端部执行器12相对于更近侧的柄部6处于远侧。还应当理解,为便利和清楚起见,本申请结合附图使用例如“竖直”和“水平”之类的空间术语。然而,外科器械在多个取向和位置中使用,并且这些术语并非意图进行限制,也并非绝对。
闭合触发器18可首先被致动。一旦临床医生对于端部执行器12的定位感到满意,则临床医生可将闭合触发器18拉回至其紧邻手枪式握把26的完全闭合、锁定的位置。然后,可致动击发触发器20。当临床医生移除压力时,击发触发器20返回至打开位置(在图1和图2中示出),如下文将更全面描述。当压下柄部6上的释放按钮时,可释放被锁定的闭合触发器18。释放按钮可实现为各种形式,例如图42-43所示的释放按钮30、图14所示的滑动释放按钮160和/或图16所示的按钮172。
图3-6示出根据各种实施例的旋转驱动端部执行器12和轴8的实施例。图3是根据各种实施例的端部执行器12的分解图。如图示实施例所示,除了先前提到的槽22和砧座24之外,端部执行器12可包括切割器械32、滑动件33、可拆卸地坐置在槽22中的钉仓34、以及螺旋状螺杆轴36。例如,切割器械32可为刀。砧座24可在枢轴销25处枢转地打开和闭合,枢轴销25连接至槽22的近端。砧座24还可包括位于其近端处的突出部27,所述突出部27插入机械闭合系统(下文进一步描述)的组件中以打开和闭合砧座24。当闭合触发器18被致动即被器械10的使用者内扳时,砧座24可围绕枢轴销25枢转入夹持或闭合位置。如果端部执行器12的夹持令人满意,则操作者可致动击发触发器20,如下文更详细说明的,使刀32和滑动件33沿槽22纵向行进,从而切割夹持在端部执行器12内的组织。滑动件33沿槽22的运动导致钉仓34的缝钉(未示出)被驱动穿过切断的组织并贴靠闭合的砧座24,这使缝钉弯曲而将切断的组织紧固。在各种实施例中,滑动件33可为仓34的一体部件。授予Shelton,IV等人的名称为“SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM”的美国专利6,978,921提供了更多关于二冲程切割和紧固器械的详细信息,该专利申请全文以引用的方式并入本文。滑动件33可为仓34的一部分,使得当刀32在切割操作后回缩时,滑动件33不回缩。
应该指出的是,虽然本文描述的器械10的实施例使用缝合被切断的组织的端部执行器12,但是在其它实施例中,可使用用于紧固或密封被切断的组织的不同技术。例如,也可使用利用射频能量或粘接剂来紧固被切断的组织的端部执行器。授予Yates等人的名称为“ELECTROSURGICALHEMOSTATIC DEVICE”的美国专利5,709,680以及授予Yates等人的名称为“ELECTROSURGICAL HEMOSTATIC DEVICE WITH RECESSEDAND/OR OFFSET ELECTRODES”的美国专利5,688,270公开了使用射频能量来密封被切断的组织的内窥镜式切割器械,所述专利申请全文以引用的方式并入本文。授予Jerome R.Morgan等人的美国专利申请序列号11/267,811以及授予Frederick E.Shelton,IV等人的美国专利申请序列号11/267,383公开了使用粘接剂来紧固被切断的组织的切割器械,所述专利申请全文以引用的方式并入本文。因此,虽然本文的描述涉及切割/缝合操作等,但是应当认识到:这仅是示例性实施例,并非旨在进行限制。也可使用其它的组织紧固技术。
图4和图5为根据各种实施例的端部执行器12和轴8的分解图,而图6为其侧视图。正如图示实施例中所示,轴8可包括由枢轴连接件44枢转地连接的近侧闭合管40和远侧闭合管42。远侧闭合管42包括开口45,砧座24上的突出部27插入开口45中以便打开和闭合砧座24,如下文进一步描述。近侧脊管46可设置在闭合管40,42内。通过锥齿轮组件52与次(或远侧)驱动轴50连通的主旋转(或近侧)驱动轴48可设置在近侧脊管46内。次驱动轴50连接至与螺旋状螺杆轴36的近侧驱动齿轮56接合的驱动齿轮54。立式锥齿轮52b可位于近侧脊管46远端的开口57中且可在其中枢转。远侧脊管58可用来包封次驱动轴50和驱动齿轮54,56。总的来说,主驱动轴48、次驱动轴50和铰接组件(例如锥齿轮组件52a-c)在本文中有时称为“主驱动轴组件”。
定位在钉槽22远端处的轴承38容纳螺旋状驱动螺杆轴36,从而允许螺旋状驱动螺杆轴36相对于槽22自由旋转。螺旋状螺杆轴36可交接刀32的带螺纹开口(未示出),使得轴36的旋转使得刀32朝远侧或近侧(根据旋转方向)平移穿过钉槽22。因此,当击发触发器20的致动造成主驱动轴48旋转(在下面详细解释)时,锥齿轮组件52a-c使次驱动轴50旋转,这继而又由于驱动齿轮54,56的接合而导致螺旋状螺杆轴36旋转,这使刀驱动构件32沿槽22纵向行进而切割被夹持在端部执行器12内的任何组织。滑动件33可由例如塑料制成,并且可具有倾斜的远侧表面。由于滑动件33横贯槽22,因此其倾斜前表面可上推或驱动钉仓中的缝钉穿过被夹持的组织,并抵靠砧座24。砧座24使缝钉弯曲,从而缝合被切断的组织。当刀32回缩时,刀32与滑动件33可脱离,从而使滑动件33留在槽22的远端处。
如上所述,由于缺乏针对切割/缝合操作的使用者反馈,医生普遍不太接受仅通过按下按钮来致动切割/缝合操作的马达驱动直线切割器。相比之下,本发明的实施例提供了马达驱动直线切割器,其具有针对端部执行器12中的切割器械32的部署、力和/或位置的使用者反馈。
图7-10示出马达驱动端部执行器(特别是其柄部)的示例性实施例,该实施例提供关于端部执行器12中的切割装置32的部署和加载力的使用者反馈。此外,该实施例可利用使用者在回缩击发触发器20时提供的动力来对装置供能(所谓的“动力辅助”模式)。该实施例可与上述的旋转驱动端部执行器12和轴8的实施例一起使用。如图示实施例中所示,柄部6包括外部下侧件59,60和外部上侧件61,62,它们配合在一起以在整体上形成柄部6的外部。例如锂离子电池之类的电池64可设置在柄部6的手枪式握把部26中。电池64驱动设置在柄部6的手枪式握把部26的上部中的电动马达65。根据多个实施例,马达65可为DC有刷驱动马达,其具有大约25000RPM的最大转速。也可使用其它合适类型的电动马达。马达65可驱动包括第一锥齿轮68和第二锥齿轮70的90°锥齿轮组件66。锥齿轮组件66可驱动行星式齿轮组件72。行星式齿轮组件72可包括连接至驱动轴76的小齿轮74。小齿轮74可驱动配对的环形齿轮78,该环形齿轮通过驱动轴82来驱动螺旋齿轮鼓80。环84可螺纹接合在螺旋齿轮鼓80上。因此,当马达65旋转时,环84利用介于其间的锥齿轮组件66、行星式齿轮组件72和环形齿轮78而沿螺旋齿轮鼓80行进。
柄部6还可包括与击发触发器20连通的运行马达传感器110(见图10),以检测操作者何时已将击发触发器20拉近(或“闭合”)柄部6的手枪式握把部26,从而通过端部执行器12致动切割/缝合操作。传感器110可为比例传感器,例如变阻器或可变电阻器。当拉回击发触发器20时,传感器110检测该运动并发出指示要供给马达65的电压(或功率)的电信号。当传感器110为可变电阻器等时,马达65的转速可与击发触发器20的运动量大致成比例。也就是说,如果操作者仅轻微拉动或闭合击发触发器20,则马达65的转速较低。当完全拉回击发触发器20(或处于完全闭合位置)时,马达65的转速为其最大值。换句话讲,使用者越用力拉动击发触发器20,施加到马达65的电压就越大,从而转速就越大。
柄部6可包括邻近击发触发器20上部的中间柄部件104。柄部6还可包括连接在中间柄部件104上的柱和击发触发器20上的柱之间的偏置弹簧112。偏置弹簧112可将击发触发器20偏置到其完全打开位置。这样,当操作者释放击发触发器20时,偏置弹簧112将击发触发器20拉向其打开位置,由此移除传感器110的致动,从而停止马达65的旋转。此外,借助于偏置弹簧112,每当使用者闭合击发触发器20时,使用者将感受到对闭合操作的阻力,从而向使用者提供有关马达65所施加的旋转量的反馈。另外,操作者可停止回缩击发触发器20以由此将力从传感器100移除,从而使马达65停止。这样,使用者即可停止部署端部执行器12,从而为操作者提供了对切割/紧固操作进行控制的措施。
螺旋齿轮鼓80的远端包括驱动环形齿轮122的远侧驱动轴120,所述环形齿轮122与小齿轮124配合。小齿轮124连接至主驱动轴组件的主驱动轴48。这样,马达65的旋转使得主驱动轴组件旋转,从而致动端部执行器12,如上所述。
螺纹接合在螺旋齿轮鼓80上的环84可包括设置在开槽臂90的狭槽88内的柱86。开槽臂90在其相对端94上具有开口92,开口92容纳连接在柄部外侧件59,60之间的枢轴销96。枢轴销96还穿过击发触发器20中的开口100和中间柄部件104中的开口102而设置。
此外,柄部6可包括反向马达传感器(或冲程结束传感器)130和止动马达(或冲程开始)传感器142。在各种实施例中,反向马达传感器130可为位于螺旋齿轮鼓80远端处的限位开关,使得螺纹接合在螺旋齿轮鼓80上的环84在其到达螺旋齿轮鼓80的远端时接触并触动反向马达传感器130。反向马达传感器130在被启动时向马达65发送信号,以使其旋转反向,从而在切割操作后回缩端部执行器12的刀32。
止动马达传感器142可为例如常闭限位开关。在多个实施例中,其可位于螺旋齿轮鼓80的近端处,使得环84在其到达螺旋齿轮鼓80的近端时触动开关142。
在操作过程中,器械10的操作者回拉击发触发器20时,传感器110检测到击发触发器20的部署并向马达65发出信号以使马达65正向旋转,例如使马达以与操作者回拉击发触发器20的力度成比例的速率旋转。马达65的正向旋转继而使得行星式齿轮组件72的远端处的环形齿轮78旋转,从而使得螺旋齿轮鼓80旋转,使螺纹连接在螺旋齿轮鼓80上的环84沿螺旋齿轮鼓80朝远侧行进。螺旋齿轮鼓80的旋转还驱动如上所述的主驱动轴组件,这继而导致部署端部执行器12中的刀32。也就是说,使得刀32和滑动件33纵向横贯槽22,从而切割被夹持在端部执行器12中的组织。此外,在使用缝合型端部执行器12的实施例中使端部执行器12进行缝合操作。
当端部执行器12的切割/缝合操作完成时,螺旋齿轮鼓80上的环84将已到达螺旋齿轮鼓80的远端,从而使反向马达传感器130被触动,传感器130将信号发送至马达65以使马达65的旋转反向。这继而使得刀32回缩,并且还使螺旋齿轮鼓80上的环84运动回到螺旋齿轮鼓80的近端。
中间柄部件104包括与开槽臂90接合的后侧肩106,如图8和图9中清晰显示。中间柄部件104还具有接合击发触发器20的向前运动止挡件107。如以上所解释,开槽臂90的运动受马达65旋转的控制。当开槽臂90随着环84从螺旋齿轮鼓80的近端行进到远端而逆时针旋转时,中间柄部件104将不受约束而逆时针旋转。因此,当使用者拉近击发触发器20时,击发触发器20将与中间柄部件104的向前运动止挡件107接合,使中间柄部件104逆时针旋转。然而,由于后侧肩106与开槽臂90接合,中间柄部件104将只能够在开槽臂90许可的范围内逆时针旋转。这样一来,如果马达65出于某种原因停止旋转,则开槽臂90就会停止旋转,使用者会无法进一步拉近击发触发器20,由于中间柄部件104由于开槽臂90而不能自由逆时针旋转。
图10A和10B示出了根据本发明的各种实施例的可用作运行马达传感器110的可变传感器的两种状态。传感器110可包括表面部分280、第一电极(A)282、第二电极(B)284以及电极282,284之间的可压缩电介质材料286,例如电活性聚合物(EAP)。传感器110可被定位成使得在回缩时使表面部分280接触击发触发器20。因此,当击发触发器20回缩时,电介质材料286被压缩,如图10B所示,使得电极282,284一起靠得更近。电极282,284之间的距离“b”直接关系到电极282,284之间的阻抗,距离越大阻抗就越大,距离越小阻抗就越小。这样,由于击发触发器20的回缩而使电介质286被压缩的量(图42中以力“F”表示)与电极282,284之间的阻抗成比例,这可用于按比例控制马达65。
图7-10中还显示了用于通过回缩闭合触发器18来闭合(或夹持)端部执行器12的砧座24的示例性闭合系统的组件。在图示实施例中,该闭合系统包括通过枢轴销251连接至闭合触发器18的轭250,所述枢轴销251被插入穿过对准的位于闭合触发器18和轭250这二者上的开口。闭合触发器18围绕其枢转的枢轴销252插入穿过闭合触发器18中的另一开口,该开口偏离销251插入穿过闭合触发器18的位置。因此,闭合触发器18的回缩使得闭合触发器18的上部逆时针旋转,轭250经由销251附接到闭合触发器18。轭250的远端经由销254连接至第一闭合托架256。第一闭合托架256连接至第二闭合托架258。闭合托架256,258共同限定开口,近侧闭合管40(见图4)的近端被坐置和保持在该开口中,使得闭合托架256,258的纵向运动引起近侧闭合管40的纵向运动。器械10还包括设置在近侧闭合管40内部的闭合杆260。闭合杆260可包括窗261,位于柄部外部件中的一个(例如图示实施例中的外部下侧件59)上的柱263设置在窗261中,以将闭合杆260固定地连接至柄部6。这样,近侧闭合管40能够相对于闭合杆260纵向运动。闭合杆260还可包括远侧卡圈267,其装配在近侧脊管46中的腔269内并由帽271(见图4)保持在腔内。
在操作中,当轭250由于闭合触发器18的回缩而旋转时,闭合托架256,258使得近侧闭合管40朝远侧运动(即远离器械10的柄部端),这使得远侧闭合管42朝远侧运动,从而使得砧座24绕枢轴销25旋转到夹持或闭合位置。当闭合触发器18被从锁定位置释放时,导致近侧闭合管40朝近侧滑动,从而使得远侧闭合管42朝近侧滑动,通过插入远侧闭合管42的窗45中的突出部27,导致砧座24绕枢轴销25枢转至打开或松开位置。这样,通过回缩并锁定闭合触发器18,操作者可将组织夹持在砧座24和槽22之间,并能够在切割/缝合操作后通过将闭合触发器20从锁定位置释放来松开该组织。
图11是根据本发明各种实施例的器械10的电路的示意图。当操作者在锁定闭合触发器18后开始牵拉击发触发器20时,传感器110被启动,从而使电流从中流过。如果常开反向马达传感器开关130打开(表明还未到达端部执行器冲程的端部),则电流将流向单刀双掷继电器132。由于反向马达传感器开关130未闭合,则继电器132的电感器134将不通电,因此继电器132将处于其未通电状态。该电路还包括仓闭锁传感器136。如果端部执行器12包括钉仓34,则传感器136将处于闭合状态,从而使电流流动。相反,如果端部执行器12不包括钉仓34,则传感器136断开,从而防止电池64向马达65供电。
当钉仓34存在时,传感器136闭合,为单刀单掷继电器138供电。当为继电器138供电时,电流流经继电器136,流过可变电阻器传感器110,并经由双刀双掷继电器140到达马达65,从而为马达65供电并使其正向旋转。
当端部执行器12达到其冲程结束时,反向马达传感器130将被启动,从而闭合开关130并为继电器134供电。这使继电器134处于其通电状态(图13中未示出),这导致电流绕过仓闭锁传感器136和可变电阻器110而流向常闭双刀双掷继电器142并流回马达65,但是以导致马达65反向旋转的方式经过继电器140。
因为止动马达传感器开关142是常闭的,因此电流将流回到继电器134以保持其闭合,直到开关142断开。当刀32完全回缩时,止动马达传感器开关142被启动,使得开关142断开,从而使马达65断电。
在其它实施例中,可使用通断型传感器而不是比例型传感器110。在此类施例中,马达65的转速将不与由操作者施加的力成比例。确切地讲,马达65一般以恒速旋转。但是由于击发触发器20与齿轮驱动系接合,因此操作者仍将感受到力反馈。
图12为根据另一个实施例的动力辅助机动化直线切割器的柄部6的侧视图。图12的实施例与图7-10的实施例类似,不同的是:图12的实施例中不存在与螺纹接合在螺旋齿轮鼓80上的环84连接的开槽臂。相反,在图12的实施例中,环84包括当环84在螺旋齿轮鼓80上向下(和向后)行进时随环84一起运动的传感器部分114。传感器部分114包括凹口116。反向马达传感器130可位于凹口116的远端处,并且止动马达传感器142可位于凹口116的近端处。当环84在螺旋齿轮鼓80上向下(和向后)运动时,传感器部分114与其一起运动。此外,如图12所示,中间件104可具有延伸到凹口12中的臂118。
在操作中,当器械10的操作者朝手枪式握把26回缩击发触发器20时,运转马达传感器110检测该运动并发送信号以向马达65供电,此外,这还使螺旋齿轮鼓80旋转。当螺旋齿轮鼓80旋转时,螺纹接合在螺旋齿轮鼓80上的环84前进(或者回缩,取决于旋转方向)。此外,由于击发触发器20的向内扣动,因此,中间件104由于与击发触发器20接合的向前运动止挡件107而随击发触发器20逆时针旋转。中间件104的逆时针旋转导致臂118随着环84的传感器部分114逆时针旋转,致使臂118保持设置在凹口116内。当环84到达螺旋齿轮鼓80的远端时,臂118将接触并因此触动反向马达传感器130。相似地,当环84到达螺旋齿轮鼓80的近端时,臂将接触并因此触动止动马达传感器142。这类动作会分别使马达65反转和停止,分别如上所述。
图13为根据另一个实施例的动力辅助机动化直线切割器的柄部6的侧视图。图13的实施例类似于图7-10的实施例,不同的是在图13的实施例中,臂90中没有狭槽。相反,螺纹接合在螺旋齿轮鼓80上的环84包括竖直槽126。臂90包括设置在槽126中的柱128来代替狭槽。当螺旋齿轮鼓80旋转时,螺纹接合在螺旋齿轮鼓80上的环84前进(或者回缩,取决于旋转方向)。由于柱128设置在槽126中,因此臂90随着环84的推进而逆时针旋转,如图13所示。
如上所述,在使用双冲程机动化器械时,操作者首先向后拉动并锁定闭合触发器18。图14和图15示出了将闭合触发器18锁定到柄部6的手枪式握把部26的方式的一个实施例。在图示实施例中,手枪式握把部26包括吊钩150,其通过扭转弹簧152而偏向于绕枢轴点151逆时针旋转。此外,闭合触发器18包括闭合杆154。操作者将闭合触发器18回扣时,闭合杆154与吊钩150的倾斜部分156接合,从而使吊钩150向上(或在图14-15中的顺时针方向)旋转,直至闭合杆154完全通过倾斜部分156并进入吊钩150的凹进的缺口158,从而将闭合触发器18锁定到位。操作者可通过向下推动位于手枪式握把部26的后侧或相对侧上的滑动释放按钮160来释放闭合触发器18。推下滑动释放按钮160使吊钩150顺时针旋转,从而使闭合杆154从凹进的缺口158释放。
图16示出了根据多个实施例的另一种闭合触发器锁定机构。在图16的实施例中,闭合触发器18包括具有箭头部分161的楔形件160。箭头部分161通过片簧162向下(或顺时针方向)偏置。楔形件160和片簧162可由例如模制塑料制成。当拉回闭合触发器18时,箭头部分161插入穿过柄部6的手枪式握把部26中的开口164。箭头部分161的下部斜面166与开口164的下侧壁168接合,迫使箭头部分161逆时针旋转。最后,下部斜面166完全通过下侧壁168,作用于箭头部分161的逆时针力被消除,从而使下侧壁168滑入箭头部分161后面的缺口170中的锁定位置。
要释放闭合触发器18,使用者可按下闭合触发器18的相对侧上的按钮172,使箭头部分161逆时针旋转,并让箭头部分161滑出开口164。
图17-22示出根据另一个实施例的闭合触发器锁定机构。如该实施例中所示,闭合触发器18包括纵向柔性臂176,纵向柔性臂176包括从其中延伸的侧销178。臂176和销178可由例如模制塑料制成。柄部6的手枪式握把部26包括开口180,开口180具有设置在其中的侧向延伸的楔形件182。当闭合触发器18回缩时,销178与楔形件182接合,并且销178被楔形件182的下表面184压下(即臂176顺时针旋转),如图17和18所示当销178完全通过下表面184时,臂176上顺时针的力被去除,且销178逆时针旋转,使得销178落入楔形件182后的缺口186中,如图19所示,从而锁定闭合触发器18。销178进一步通过从楔形件184延伸的柔性止挡件188而在锁定位置中保持就位。
为了将闭合触发器18释放,操作者可进一步挤压闭合触发器18,从而使销178接合开口180的倾斜后壁190,从而迫使销178向上越过柔性止挡件188,如图20和图21所示。然后销178在开口180中自由地从上部槽192移出,使得闭合触发器18不再被锁定到手枪式握把部26,如图22所示。
图23A-B示出万向接头(“u-joint”)195。万向接头195的第二构件195-2在水平面上旋转,第一构件195-1位于该水平面中。图23A示出直线(180°)取向的万向接头195,并且图23B示出呈大约150°取向的万向接头195。可在主驱动轴组件的铰接点14处用万向接头195代替锥齿轮52a-c(例如见图4),以使端部执行器12进行铰接活动。图24A-B示出了扭力缆线197,其可用于代替锥齿轮52a-c和万向接头195,以实现端部执行器12的铰接连接。
图25-31示出了根据本发明的另一个实施例的机动化的二冲程外科切割和紧固器械10的另一个实施例,该器械具有动力辅助。图25-31的实施例类似于图6-10的实施例,不同的是图23-28的实施例包括替代的齿轮驱动组件,而不是螺旋齿轮鼓80。图25-31的实施例包括齿轮箱组件200,其包括设置在机架201中的许多齿轮,其中这些齿轮连接在行星式齿轮72与驱动轴48近端处的小齿轮124之间。如下文进一步解释,齿轮箱组件200通过击发触发器20为使用者提供关于端部执行器12的部署和加载力的反馈。而且,使用者可通过齿轮箱组件200为系统提供动力,以辅助端部执行器12的部署。从那个意义上说,类似于如上所述的实施例,图23-32的实施例是另一种动力辅助机动化器械10,其可向使用者提供关于器械所受到的加载力的反馈。
在图示实施例中,触发器20包括两个部件:主体部分202和加劲部分204。主体部分202可由例如塑料制成,并且加劲部分204可由更刚性的材料(例如金属)制成。在图示实施例中,加劲部分204邻近主体部分202,但根据其它实施例,加劲部分204可设置在主体部分202的内部。枢轴销207可插入穿过击发触发器件202,204中的开口并可为击发触发器20围绕其旋转的点。此外,弹簧222可使击发触发器20偏置以按逆时针方向旋转。弹簧222可具有连接至销224的远端,销224连接至击发触发器20的件202,204。弹簧222的近端可连接至柄部外部下侧件59,60中的一者。
在图示实施例中,主体部分202和加劲部分204两者在其上端部分处(分别)包括齿轮部206,208。齿轮部206,208接合齿轮箱组件200中的齿轮(如下文所解释),以驱动主驱动轴组件并为使用者提供关于端部执行器12部署的反馈。
如在图示实施例中所示,齿轮箱组件200可包括六(6)个齿轮。齿轮箱组件200的第一齿轮210接合击发触发器20的齿轮部206,208。此外,第一齿轮210接合更小的第二齿轮212,更小的第二齿轮212与大的第三齿轮214共轴。第三齿轮214接合更小的第四齿轮216,更小的第四齿轮与第五齿轮218共轴。第五齿轮218为90°锥齿轮,其接合连接至小齿轮124的配对的90°锥齿轮220(图31中清晰示出),小齿轮124驱动主驱动轴48。
在操作时,当使用者回缩击发触发器20时,运转马达传感器(未示出)被启动,其可向马达65提供信号,使之以与操作者回缩击发触发器20的程度或力成比例的速度旋转。这使得马达65以与来自传感器的信号成比例的速度旋转。此实施例中未示出传感器,但其可类似于上述的运转马达传感器110。传感器可位于柄部6中,使得其在击发触发器20回缩时被压下。此外,可用通/断型传感器而不是比例型传感器。
马达65的旋转使锥齿轮68,70旋转,这导致行星齿轮72旋转,从而通过驱动轴76使环形齿轮122旋转。环形齿轮122与小齿轮124啮合,所述小齿轮124连接至主驱动轴48。因此,小齿轮124的旋转驱动主驱动轴48,这导致致动端部执行器12的切割/缝合操作。
小齿轮124的向前旋转继而使锥齿轮220旋转,从而通过齿轮箱组件200的其它齿轮来使第一齿轮210旋转。第一齿轮210与击发触发器20的齿轮部分206,208接合,从而在马达65对端部执行器12提供向前驱动时使击发触发器20逆时针旋转(并且在马达65反转而使端部执行器12回缩时逆时针旋转)。这样,使用者通过其握持击发触发器20来感受关于端部执行器12的加载力和部署的反馈。因此,当使用者回缩击发触发器20时,操作者将感受到与端部执行器12受到的加载力有关的阻力。同样地,在切割/缝合操作后操作者将击发触发器20释放以使其返回到原来位置,使用者将体验到来自击发触发器20的大致与马达65的反向速度成比例的顺时针旋转力。
还应该指出的是,在此实施例中,使用者可施加力(代替或补充来自马达65的力)以通过回缩击发触发器20来致动主驱动轴组件(并从而致动端部执行器12的切割/缝合操作)。也就是说,拉回击发触发器20使齿轮部分206,208逆时针旋转,这导致齿轮箱组件200的齿轮旋转,从而导致小齿轮124旋转,这导致主驱动轴48旋转。
尽管在图25-31中未示出,但是器械10还可包括反向马达传感器和止动马达传感器。如上所述,反向马达传感器和止动马达传感器可分别检测切割冲程的结束(刀32的全面部署)以及回缩操作的结束(刀32的全面回缩)。与上述图11相关的电路的类似电路可用于为马达65适当供电。
图32-36示出根据另一个实施例的带动力辅助的双冲程机动化外科切割和紧固器械10。图32-36的实施例类似于图25-31的实施例,不同的是在图32-36的实施例中,击发触发器20包括下部228和上部230。下部228、上部230两者均与穿过下部228、上部230设置的枢轴销207连接并围绕其枢转。上部230包括与齿轮箱组件200的第一齿轮210接合的齿轮部232。弹簧222连接至上部230,使得上部受到偏置以按顺时针方向旋转。上部230可还包括与击发触发器20的下部228的上表面接触的下臂234,这样,当上部230因此以顺时针旋转时下部228也顺时针旋转,并且当下部228逆时针旋转时上部230也逆时针旋转。同样,下部228包括与上部230的肩部接合的旋转止挡件238。由此,当上部230因此逆时针旋转时下部228也逆时针旋转,并且当下部228顺时针旋转时上部230也顺时针旋转。
图示实施例还包括给马达65传送信号的运转马达传感器110,在各种实施例中,该信号可使马达65以与操作者回缩击发触发器20时施加的力成比例的速度旋转。传感器110可为例如变阻器或某些其它可变电阻传感器,如本申请所述。此外,器械10可包括反向马达传感器130,其在与击发触发器20的上部230的正面242接触时触动或切换。当被启动时,反向马达传感器130将信号发送至马达65,以使其反向。此外,器械10可包括在与击发触发器20的下部228接触时被触动或致动的止动马达传感器142。当被启动时,止动马达传感器142发送信号以停止马达65的反向旋转。
在操作中,当操作者将闭合触发器18回缩到锁定位置时,击发触发器20略微回缩(通过本领域已知的机构,包括授予Frederick Shelton,IV等人的美国专利6,978,921和授予Jeffery S.Swayze等人的美国专利6,905,057,所述专利全文以引用的方式并入本文),使得使用者可抓握击发触发器20来开始切割/缝合操作,如图32和图33所示。此时,如图33所示,击发触发器20的上部230的齿轮部232与齿轮箱组件200的第一齿轮210运动接合。当操作者回缩击发触发器20时,根据各种实施例,在触动运转马达传感器110之前,击发触发器20可旋转较小的量(例如5度),如图34中所示。传感器110的启动使马达65以与由操作者施加的回缩力成比例的速度正向旋转。如上所述,马达65的正向旋转引起主驱动轴48旋转,这使得端部执行器12中的刀32被部署(即开始穿过槽22)。连接至主驱动轴48的小齿轮124的旋转使齿轮箱组件200中的齿轮210-220旋转。由于第一齿轮210与击发触发器20的上部230的齿轮部分232接合,因此上部232逆时针旋转,这导致下部228也逆时针旋转。
当刀32的部署完成(即在切割冲程结束)时,上部230的正面242触动反向马达传感器130,反向马达传感器130将信号发送至马达65,使其反方向旋转。这使得主驱动轴组件反方向旋转以回缩刀32。主驱动轴组件的反向旋转也导致齿轮箱组件中齿轮210-220换向,这导致击发触发器20的上部230顺时针旋转,这导致击发触发器20的下部228顺时针旋转,直到刀32完全回缩时下部228触动或致动止动马达传感器142,从而使马达65停止。这样,使用者通过其握持击发触发器20来感受关于端部执行器12的部署的反馈。因此,当使用者回缩击发触发器20时,操作者将感受到与端部执行器12的部署有关的阻力,特别是与由于刀32受到的加载力有关的阻力。同样地,在切割/缝合操作后操作者将击发触发器20释放以使其返回到原来位置,使用者将体验到来自击发触发器20的大致与马达65的反向速度成比例的顺时针旋转力。
还应该指出的是,在此实施例中,使用者可施加力(代替或补充来自马达65的力)以通过回缩击发触发器20来致动主驱动轴组件(并从而致动端部执行器12的切割/缝合操作)。也就是说,回缩击发触发器20导致上部230的齿轮部分232逆时针旋转,这导致齿轮箱组件200的齿轮旋转,从而使小齿轮124旋转,这又使主驱动驱动轴组件旋转。
以上所述的实施例采用动力辅助用户反馈系统,其中带或不带用于二冲程机动化手术切割和紧固器械的自适应控制(例如,在马达65、齿轮驱动系和端部执行器12的闭环系统之外使用传感器110,130和142)。也就是说,由于击发触发器20被(直接或间接地)接合到马达65和主驱动轴48之间的齿轮驱动系中,由使用者施加的用以回缩击发触发器20的力可被添加到由马达65施加的力。在本发明的其它实施例中,可向使用者提供关于端部执行器中的刀32位置的触觉反馈,但击发触发器20不接合到齿轮传动系中。图37-40示出了具有此类触觉位置反馈系统的机动化外科切割和紧固器械。
在图37-40示出的实施例中,击发触发器20可具有下部228和上部230,类似于图32-36中示出的器械10。然而,不同于图32-36的实施例,上部230不具有与部分齿轮驱动系配合的齿轮部。相反,该器械包括带有螺纹接合在其中的螺杆266的第二马达265。当马达265旋转时,螺杆266纵向往复进出马达265(取决于旋转方向)。器械10还包括编码器268,其响应主驱动轴48的旋转,将主驱动轴48(或主驱动轴组件的其它部件)的增量角运动转化成例如对应的一系列数字信号。在图示实施例中,小齿轮124包括连接至编码器268的近侧驱动轴270。
器械10还包括可使用微控制器或一些其它类型的集成电路实现的控制电路(未示出),该控制电路接收来自编码器268的数字信号。基于来自编码器268的信号,控制电路可计算端部执行器12中刀32部署的阶段。也就是说,控制电路可计算刀32是否完全部署、完全回缩或处于中间阶段。基于对端部执行器12部署阶段的计算结果,控制电路可将信号发送至第二马达265以控制其旋转,从而控制螺杆266的往复运动。
在操作中,如图37所示,当闭合触发器18未锁定到夹持位置时,击发触发器20远离柄部6的手枪式握把部26旋转,使得击发触发器20的上部230的前表面242不与螺杆266的近端接触。当操作者回缩闭合触发器18并将其锁定在夹持位置时,击发触发器20略微朝闭合触发器20旋转,使操作者可握持击发触发器20,如图38所示。在此位置,上部230的前表面242接触螺杆266的近端。
作为使用者,然后回缩击发触发器20,在经过最初的旋转量(例如5度的旋转)后运行马达传感器110可被启动,如上面所解释,传感器110发送信号到马达65以使它以与操作者施加于击发触发器20的回缩力的量成比例的速度正向旋转。马达65的正向旋转通过齿轮驱动系使主驱动轴48旋转,由此使得刀32和滑动件33沿着槽22向下行进并切断夹持在端部执行器12中的组织。控制电路接收来自编码器268的关于主驱动轴组件的增量旋转的输出信号,将信号发送到第二马达265以使第二马达265旋转,由此使得螺杆266回缩到马达265中。这允许击发触发器20的上部230逆时针旋转,从而允许击发触发器的下部228也逆时针旋转。这样,由于螺杆266的往复运动与主驱动轴组件的旋转相关,因此器械10的操作者通过他/她握持击发触发器20来感受关于端部执行器12位置的触觉反馈。然而,由操作者施加的回缩力不直接影响主驱动轴组件的驱动,因为击发触发器20并未接合到该实施例中的齿轮驱动系中。
通过对来自编码器268的输出信号对主驱动轴组件的增量旋转进行跟踪,控制电路可计算刀32何时被完全部署(即完全伸展)。此时,控制电路可将信号发送至马达65以反转方向,从而使刀32回缩。马达65的反转方向使主驱动轴组件反向旋转,这也被由编码器268检测。基于编码器268检测到的反向旋转,控制电路将信号发送至第二马达265以使其反转,使得螺杆266开始从马达265纵向延伸。该运动迫使击发触发器20的上部230顺时针旋转,从而导致下部228顺时针旋转。这样,操作者可体验到来自击发触发器20的顺时针力,这给操作者提供了关于端部执行器12中刀32的回缩位置的反馈。控制电路可确定刀32何时完全回缩。此时,控制电路可将信号发送至马达65以使其停止旋转。
根据其它实施例,可使用反向马达传感器和止动马达传感器而不是用控制电路来确定刀32的位置,如上所述。此外,可使用通/断开关或传感器而不是用比例传感器110来控制马达65的旋转。在此类实施例中,操作者不能够控制马达65的转速。确切地说,马达将以预编程的速度旋转。
图41-43示出了机械致动的直线切割器,并且具体地为柄部6、轴8和其端部执行器12的示例性实施例。机械致动的直线切割器的更多详细信息可见于名称为“Surgical Stapling Instrument Incorporating A Multi-StrokeFiring Mechanism With Automatic End Of Firing Travel Retraction”的美国专利申请序列号11/052,632,该专利申请全文以引用的方式并入本文。参照图41,端部执行器12响应来自柄部6的闭合运动(图41中未示出),首先通过包括砧座面1002连接至砧座近端1004来响应,所述砧座近端1004包括位于垂直突出的砧座突出部27的近侧的侧向突出的砧座枢轴销25。砧座枢轴销25在钉槽22中的肾形开口1006内平移,以相对于槽22打开和闭合砧座24。突出部27接合弯片1007,所述弯片向内伸入闭合管1005的远端1008上的突出部开口45,所述闭合管在远侧终止于远侧边缘1008,所述远侧边缘压靠在砧座端面1002上。因此,当闭合管1005从其开口位置朝近侧运动时,闭合管1005的弯片1007将砧座突出部27朝近侧拉动,并且砧座枢轴销25沿着钉槽22中的肾形开口1006移动,使得砧座24同时地朝近侧平移并向上旋转至打开位置。当闭合管1005朝远侧运动时,突出部开口45中的弯片1007从砧座突出部27释放,并且远侧边缘1008压在砧座端面1002上,将砧座24闭合。
继续参照图41,轴8和端部执行器12还包括响应击发杆1010的击发运动的部件。具体地,击发杆1010可旋转地接合具有纵向凹槽1014的击发槽构件1012。击发槽构件1012直接响应击发杆1010的纵向运动,在框架1016内纵向运动。闭合管1005中的纵向狭槽1018可操作地与柄部6的右外侧柄部件61和左外侧柄部件62联接(图41中未示出)。闭合管1005中的纵向狭槽1018的长度足够长以允许相对于柄部件61,62的纵向运动以分别完成击发和闭合运动,柄部件61,62的联接通过框架1016中的纵向狭槽1020传递,以与框架槽构件1012中的纵向凹槽1014滑动接合。
框架槽构件1012的远端附接到在框架1016内,具体地在导向装置1024内运动的击发杆1022的近端,以使刀32朝远侧突出到端部执行器12中。端部执行器12包括由刀32致动的钉仓34。钉仓34具有托盘1028,该托盘容纳钉仓主体1030、楔形滑动件驱动器33、缝钉驱动器1034和缝钉1036。应当理解,楔形滑动件驱动器33可在位于仓托盘1028和仓体1030之间的击发凹槽(未图示)内纵向运动。楔形滑动件驱动器33呈现凸轮表面,这些凸轮表面接触并托起缝钉驱动器1034,驱动缝钉1036。钉仓体1030还包括在近侧开口的竖直狭槽1031用作刀32的通道。具体而言,沿着刀32的远端设有切割表面1027,在组织被缝合后切割组织。
应当理解,图4中轴8被示出为非铰接轴。但是,本发明的应用可包括能够进行铰接的器械,例如如上结合图1-4所示的器械以及以下的美国专利和专利申请中所述的器械,每个公开据此全文以引用方式并入:(1)由Frederick E.Shelton IV、Brian J.Hemmelgarn、Jeffrey S.Swayze、Kenneth S.Wales于2003年7月9日提交的名称为“SURGICAL INSTRUMENTINCORPORATING AN ARTICULATION MECHANISM HAVINGROTATION ABOUT THE LONGITUDINAL AXIS”的美国专利申请公布2005/0006434;(2)授予Brian J.Hemmelgarn的名称为“SURGICALSTAPLING INSTRUMENT INCORPORATING AN ARTICULATION JOINTFOR A FIRING BAR TRACK”的美国专利6,786,382;(3)授予Jeffrey S.Swayze的名称为“A SURGICAL INSTRUMENT WITH A LATERAL-MOVING ARTICULATION CONTROL”的美国专利6,981,628;(4)授予Frederick E.Shelton IV、Michael Setser、Bruce Weisenburgh II的名称为“SURGICAL STAPLING INSTRUMENT INCORPORATING A TAPEREDFIRING BAR FOR INCREASED FLEXIBILITY AROUND THEARTICULATION JOINT”的美国专利6,964,363;以及(5)由Jeffrey S.Swayze、Joseph Charles Hueil于2003年7月9日提交的名称为“SURGICAL STAPLING INSTRUMENT HAVING ARTICULATION JOINTSUPPORT PLATES FOR SUPPORTING A FIRING BAR”的美国专利申请公布2005/0006431。
图42-43示出了柄部6的实施例,该柄部能够与以上图41所示的轴8和端部执行器12的实施例一起用于一种机械致动的直线切割器。应当理解,任何合适的柄部设计都可用来机械地闭合并击发端部执行器12。图42-43中,外科缝合和切断器械10的柄部6包括联动击发机构(linkedtransmission firing mechanism)1060,该机构具有增强的强度、减小的柄部尺寸、最小化的约束力等特征。
端部执行器12(图42-43中未示出)的闭合通过朝柄部6的手枪式握把部26压下闭合触发器18而实现。闭合触发器18围绕闭合枢轴销252枢转,该闭合枢轴销联接到柄部6的右外部下侧件59和左外部下侧件60,使闭合触发器18的上部1094向前运动。闭合管1005经闭合轭250接收该闭合运动,闭合轭250通过闭合轭销1044和闭合连接销1046分别与闭合连接件1042和闭合触发器18的上部1094销连接。
在图42所示的完全打开位置,闭合触发器18的上部1094接触并保持处于所示位置的枢转闭合释放按钮30的锁定臂1048。在闭合触发器18达到其完全压下的位置时,闭合触发器18释放锁定臂1048并且邻接表面1050旋转成与枢转锁定臂1048的远侧右向缺口1052接合,从而将闭合触发器18保持在其夹持或闭合位置。锁定臂1048的近端与件59,60一起绕侧向枢转连接件1054枢转以露出闭合释放按钮30。闭合释放按钮30的中间远侧1056被压缩弹簧1058朝近侧推压,该压缩弹簧在外壳结构1040和闭合释放按钮30之间被压缩。其结果是,闭合释放按钮30将锁定臂1048逆时针(从左侧看)推至与闭合触发器18的邻接表面1050锁定接触,从而防止在联动击发系统1040处于未回缩状态时闭合触发器18松开。
在闭合触发器18回缩并完全压下的情况下,击发触发器20被解锁并在本实施例中可被压向手枪式握把26多次,以使端部执行器12进行击发。如所描述,联动击发机构1060最初被回缩,受到拉伸/压缩组合弹簧1062的作用而保持在位,所述组合弹簧约束在柄部6的手枪式握把26内,其非移动端1063连接至件59,60,并且移动端1064连接至钢带1066的向下弯折的近侧回缩端1067。
钢带1066的远侧设置末端1068附接到承受结构负载的联接构件1070,其继而又附接到多个环节1072a~1072d中的前面环节1072a,这些环节形成链接齿条1074。链接齿条1074是柔性的,但其具有形成直刚性齿条组件的远侧环节,该齿条组件可通过轴6中的击发杆1010传递有效的击发力,然而可容易地回缩到手枪式握把26内,以将柄部6的纵向长度最小化。应当理解,拉伸/压缩组合弹簧1062可增大有效的击发行程,同时基本上将最短长度缩减到单根弹簧的一半。
击发触发器20绕击发触发器销96枢转,该销连接至柄部件59,60。当击发触发器20向手枪式握把26压下时击发触发器20的上部228绕着击发触发器销96朝远侧运动,将朝近侧放置的击发触发器拉伸弹簧222朝近侧拉伸,该拉伸弹簧连接在击发触发器20的上部228和件59,60之间。在每次通过牵引偏置机构1078按压击发触发器期间,击发触发器20的上部228与链接齿条1074接合,在击发触发器20被释放时牵引偏置机构1078也脱离。击发触发器拉伸弹簧222在击发触发器20被释放时将其拉至远侧,并脱离牵引偏置机构1078。
当联动击发机构1040致动时,惰轮齿1080因与链接齿条1074的锯齿状上表面1082接合而顺时针旋转(从左侧看)。该旋转联接到指示器齿轮1084,因此其响应于惰轮齿1080作逆时针旋转。惰轮齿1080和指示器齿轮1084均与柄部6的件59,60可旋转地连接。链接齿条1074、惰轮齿1080与指示器齿轮1084之间的齿轮关系可有利地进行选择,使得锯齿状上表面1082具有强度适当的齿尺寸,并且在联动击发机构1060的整个击发行程中指示器齿轮1084的旋转不超过一圈。
如下面更详细描述,指示器齿轮1084执行至少四个功能。首先,当链接齿条1074完全回缩并且两个触发器18,20均如图42所示处于张开状态时,指示器齿轮1084左侧的圆形脊1088中的开口1086呈现给锁定臂1048的上表面1090。锁定臂1048因接触闭合触发器18而偏置进开口1086,闭合触发器继而又被闭合拉伸弹簧1092拉至打开位置。闭合触发器拉伸弹簧1092朝近侧连接至闭合触发器18的上部1094和柄部件59,60,因而在闭合触发器18的闭合过程中使能量被存储,该能量促使闭合触发器18朝远侧回到其非闭合位置。
指示器齿轮1084的第二个功能是:其连接至设于柄部6外侧的指示回缩旋钮1096。因此,指示器齿轮1084将击发机构1060的相对位置传递给指示回缩旋钮1096,使外科医生得到关于需要多少个击发触发器20的冲程来完成击发的视觉指示。
指示器齿轮1084的第三个功能是:在外科缝合和切断器械10被操作时纵向和成角度地移动止退机构(单向离合器机构)1097的止退释放杆1098。在击发冲程中,止退释放杆1098因指示器齿轮1084朝近侧移动,从而启动止退机构1097,以允许击发杆1010的远侧运动并防止击发杆1010的近侧运动。此运动也将止退释放按钮1100从柄部件59,60的近端伸出,以供操作者在击发冲程期间需要让联动击发机构1060回缩时致动。击发冲程完成后,指示器齿轮1084由于击发机构1060回缩而使旋转方向反向。反向旋转将止退机构1097释放,将止退释放按钮1100缩回柄部6内,并将止退释放杆1098侧向地旋转至右侧,以使指示器齿轮1084能够继续反向旋转。
指示器齿轮1084的第四个功能是:接受经由指示回缩旋钮1096(如图42所示的顺时针方向)的手动旋转,在止退机构1097解锁的情况下回缩击发机构1060,从而克服击发机构1060中的任何约束,该约束不容易为拉伸/压缩组合弹簧1062所克服。在击发机构1060部分击发后可使用手动辅助回缩,否则这会被使止退释放按钮1100缩回的止退机构1097阻止,使得止退释放按钮1100不会将止退释放杆1098侧向移动。
继续参照图42-43,止退机构1097由操作者可触及的止退释放杆1098构成,所述止退释放杆可操作地在其近端联接于止退释放按钮1100并在其远端联接于止退轭1102。具体而言,止退释放杆1098的远端1099通过止退轭销1104接合于止退轭1102。止退轭1102纵向移动,以将旋转传递至止退凸轮狭槽管1106,所述槽管被柄部件59,90在纵向上约束,并且在发射杆1010至链接齿条1074的联接构件1070的连接部的远侧将击发杆1010围住。止退轭1102将来自止退释放杆1098的纵向运动通过凸轮狭槽管销1108传递给止退凸轮狭槽管1106。也就是说,凸轮狭槽管销1108在止退凸轮狭槽管1106的斜向狭槽中的纵向运动使止退凸轮狭槽管1106旋转。
止退压缩弹簧1110、止退片1112和止退凸轮管1114,分别被限制在框架1016的近端和止退凸轮狭槽管1106之间。如以上描述的,击发杆1010的近侧运动导致止退片1112将顶部枢转到后方,呈现出对于击发杆1010增大的摩擦接触,这可阻止击发杆1010的进一步近侧运动。
当止退凸轮狭槽管1106与止退凸轮管1114相隔很近时,这种止退片1112以类似于可保持纱门打开的纱门门锁的方式枢转。具体而言,止退压缩弹簧1110能够作用于止退片1112的顶部表面,将止退片1112倾翻到其锁定位置。止退凸轮狭槽管1106的旋转导致止退凸轮管1114的远侧凸轮运动,从而对止退片1112的顶部朝远侧加力,克服来自止退压缩弹簧1110的力,从而将止退片1112定位在非倾(垂直)、未锁定位置,使击发杆1010能够朝近侧回缩。
特别参照图43,牵引偏置机构1078被图示为由具有朝远侧突出的狭窄末端1118的棘爪1116和在其近端向右侧突出的侧销1120组成,该侧销可旋转地插入位于击发触发器20的上部230的孔眼1076。在击发触发器20的右侧,侧销1120接受图示出为偏置轮1122的偏置构件。由于击发触发器20从头到尾的移动,偏置轮1122在柄部6的右半件59近侧的弧线上往返移动,在行程的远侧部分越过偏置坡道1124,所述偏置坡道一体地形成在右半件59中。有利地,偏置轮1122可用弹性、摩擦材料形成,这种材料可导致棘爪1116的侧销1120逆时针旋转(从左侧看),从而牵引向下偏置朝远侧突出的狭窄末端1118,进入最近的环节1072a-d的斜坡中央轨道1075而与链接齿条1074接合。
由于击发触发器20被释放,偏置轮1122因此牵引地将棘爪1116偏置到相反方向,将狭窄末端1118从链接齿条1074的斜坡中央轨道1075抬起。为了确保在高负荷情况下并且在棘爪1116的几乎全部远侧行程处使尖端1118脱离,棘爪1116的右侧斜升到闭合轭250右侧的面朝近侧和上侧的斜面1126上,以使狭窄末端1118与倾斜的中央轨道1075脱离。如果击发触发器20在全行程以外的任何点上被释放,则偏置轮1122就用来将狭窄末端1118从斜坡中央轨道1075抬起。已对偏置轮1122作了描述,但应当理解,偏置构件或偏置轮1122的形状为示例性的,可有各种变化以适应各种不同的形状,使用摩擦或牵引来接合或脱离端部执行器12的击发。
外科器械10的各种实施例具有在使用过程中一次或多次记录器械条件的能力。图44为用于记录器械10的状态的系统2000的方框图。应当理解,系统2000可用在具有机动化或马达助力击发的器械10的实施例中,例如上面参照图1-40所描述,并且可用在具有机械致动击发的器械10的实施例中,例如上面参照图41-43所描述。
系统2000可包括用于感测器械条件的各种传感器2002,2004,2006,2008,2010,2012。这些传感器可定位在例如器械10的上面或其内部。在各种实施例中,这些传感器可以是只为系统2000提供输出的专用传感器,或可以是在器械10内执行其它功能的双用途传感器。例如,上述的传感器110,130,142能够也向系统2000提供输出。
各个传感器直接或间接地向存储装置2001提供信号,存储装置2001记录下面详述的信号。存储装置2001可为能够存储或记录传感器信号的任何种类的装置。例如,存储装置2001可包括微处理器、电可擦除可编程只读存储器(EEPROM)或任何其它合适的存储装置。存储装置2001可记录由传感器以任何合适的方式提供的信号。例如在一个实施例中,存储装置2001可在信号改变状态时记录来自特定存储器的该信号。在另一个实施例中,存储装置2001可记录系统2000的状态,例如,在来自任一传感器的信号改变状态时记录来自系统2000包括的全部传感器的信号。这可提供关于器械10的状态的快照。在各种实施例中,存储装置2001和/或传感器可实现为包括可得自DALLAS SEMICONDUCTOR的单总线产品,例如单线EEPROM。
在各种实施例中,存储装置2001是可从外部存取的,允许外部设备如计算机访问由存储装置2001记录的器械条件。例如,存储装置2001可包括数据端口2020。数据端口2020可根据任何有线或无线通信协议以(例如)串行或并行格式提供所存储的器械条件。存储装置2001还可包括除了输出端口2020以外的或取代输出端口2020的可移除介质2021。可移除介质2021可为可从器械10取下的任何种类的合适的数据存储装置。例如,可移除介质2021可包括任何合适种类的闪速存储器,例如个人计算机存储卡国际协会(PCMCIA)卡、COMPACTFLASH卡、MULTIMEDIA卡、FLASHMEDIA卡等。可移除介质2021还可包括任何合适种类的基于盘的存储器,包括例如移动硬盘、光盘(CD)、数字视频盘(DVD)等。
闭合触发器传感器2002感测闭合触发器18的状态。图45和图46示出了闭合触发器传感器2002的示例性实施例。在图45和图46中,闭合触发器传感器2002定位在闭合触发器18和闭合枢轴销252之间。应当理解,将闭合触发器18扣向手枪式握把26可使闭合触发器18加力于闭合枢轴销252。例如,传感器2002可感测到该力并响应其产生信号,如以上关于传感器110并参照图10A和图10B所述。在各种实施例中,闭合触发器传感器2002可为仅指示闭合触发器18是否被致动的数字传感器。在其它各种实施例中,闭合触发器传感器2002可为指示作用于闭合触发器18的力和/或闭合触发器18的位置的模拟传感器。如果闭合触发器传感器2002为模拟传感器,则可在传感器2002和存储装置2001之间在逻辑意义上定位模数转换器。也应当理解,闭合触发器传感器2002可具有任何适当的形式,并可设于使闭合触发器的条件能够被感测的任何合适位置。
砧座闭合传感器2004可感测到砧座24是否被闭合。图47示出一种示例性的砧座闭合传感器2004。如图所示,传感器2004定位在钉槽22的肾形开口1006内或其附近。在砧座24闭合时,砧座枢轴销25滑过肾形开口1006而与传感器2004接触,导致传感器2004产生指示砧座24已被闭合的信号。传感器2004可为任何合适种类的数字或模拟传感器,包括近距离传感器等。应当理解,如果砧座闭合传感器2004为模拟传感器,则可在传感器2004和存储装置2001之间逻辑上包括模数转换器。
砧座闭合负荷传感器2006如图所示设于钉槽22的内侧底部表面上。使用时,传感器2006可能会接触钉仓34(图46中未示出)的底侧面。当砧座24闭合时,在钉仓34上施加作用力,该作用力被传送至传感器2006。作为响应,传感器2006产生信号。该信号可为与钉仓34因砧座24闭合而作用于传感器2006的力成比例的模拟信号。参照图44,该模拟信号可提供给模数转换器2014,其将该模拟信号转换成数字信号,然后提供给存储装置2001。应当理解,其中传感器2006为数字或二进制传感器的实施例可不包括模数转换器2014。
击发触发器传感器110感测击发触发器20的位置和/或状态。在机动化或马达助力的器械实施例中,击发触发器传感器可兼作以上描述的运行马达传感器110。此外,击发触发器传感器110可为上述的任何形式,并且可为模拟或数字的。图45和图46示出了击发触发器传感器110的另一实施例。在图45和图46中,击发触发器传感器安装在击发触发器20和击发触发器枢轴销96之间。击发触发器20被扣动时,会对击发触发器枢轴销96施加力,该力为传感器110所感测。参照图44,在击发触发器传感器110的输出为模拟的实施例中,包括在逻辑意义上设于击发触发器传感器110和存储装置2001之间的模数转换器2016。
刀位置传感器2008感测刀32或切割表面1027在钉槽22中的位置。图47和图48示出刀位置传感器2008的实施例,这两个实施例适于同图41所示的机械致动轴8和端部执行器12一起使用。传感器2008包括联接至器械10的击发杆1022的磁铁2009。线圈2011被定位在击发杆1022周围,并且例如可沿击发槽构件1012的纵向凹槽1014(参见图41)被安装。刀32和切割表面1027在钉槽22中往复运动,击发杆1022和磁铁2009会在线圈2011中来回运动穿过。这种相对线圈的运动感应出线圈内的电压,该电压与击发杆在线圈内的位置以及切割表面1027在钉槽22内的位置成比例。该电压可提供给存储装置2001,例如经由模数转换器2018提供。
在各种实施例中,作为替代,刀位置传感器2008可用设于轴8上或内不同位置的一系列数字传感器(未示出)来实现。数字传感器可感测到击发杆1022的特征物例如磁铁2009,在该特征物通过轴8往复运动时被感测。击发杆1022在轴8内的位置,甚至于刀32在钉槽22内的位置,可被近似为被触动的最后一个数字传感器的位置。
应当理解,在具有旋转驱动端部执行器12和轴8的器械10的实施例中也可感测到刀位置,例如以上参照图3-6所描述的情况。编码器(如编码器268)能够产生与螺旋状螺杆轴36或任何其它驱动轴或齿轮的旋转成比例的信号。由于轴36和其它驱动轴和齿轮的旋转与通过槽22的刀32的运动成比例,因此由编码器268产生的信号也与刀32的运动成比例。因此,编码器268的输出可被提供给存储装置2001。
仓存在传感器2010可感测到钉槽22内钉仓34的存在。在机动化或马达助力的器械中,钉仓存在传感器2010可兼作仓锁定传感器136,如以上参照图11所描述的情况。图50和图51示出了仓存在传感器2010的实施例。在所示的实施例中,仓存在传感器2010包括两个触点2011和2013。没有仓34存在时,触点2011,2013形成开式电路。当仓34存在时,钉仓34的仓托盘1028接触触点2011,2013而形成闭合电路。当电路打开时,传感器2010可输出逻辑0。当电路闭合时,传感器2010可输出逻辑1。传感器2010的输出被提供给存储装置2001,如图44所示。
仓条件传感器2012可指示装于钉槽22内的仓34是否已被击发即被耗用。由于刀32穿过端部执行器12平移,其推动滑动件33,而滑动件击发钉仓。然后,刀32移回其原始位置,将滑动件33留在仓的远端。如果没有滑动件33来引导,刀32会落入锁定凹坑2022中。传感器2012可感测到锁定凹坑2022中是否存在刀32,这间接地表明仓34是否已被耗用。应当理解,在各种实施例中,传感器2012可直接感测在仓34的近端处滑动件的存在,从而使刀32无需落入锁定凹坑2022中。
图52A和图52B为外科器械10的操作实施例的流程2200,外科器械10被配置成直线切割器,并具有根据各种实施例记录器械条件的能力。在框2202处,器械10的砧座24可被闭合。这导致闭合触发器传感器2002和/或砧座闭合传感器2006改变状态。作为响应,在框2203处,器械2001可记录系统2000中的所有传感器的状态。在框2204处,器械10可被插入患者体内。当器械被插入时,砧座24可在框2206处被打开和闭合,例如在手术部位处理组织。砧座24的每次打开和闭合,导致闭合触发器传感器2002和/或砧座闭合传感器2004改变状态。作为响应,存储装置2001在框2205处记录系统2000的状态。
在框2208处,组织被夹持以进行切割和缝合。如果在判定块2210处砧座24未闭合,则需要继续夹持。如果砧座24闭合,则传感器2002,2004和/或2006可改变状态,从而提示存储装置2001在框2213处记录系统的状态。这个记录可包括从传感器2006接收的闭合压力。在框2212处,可进行切割和缝合。在击发触发器20向手枪式握把26扣动时,击发触发器传感器110可改变状态。此外,当刀32穿过钉槽22时,刀位置传感器2008会改变状态。作为响应,存储装置2001可在框2013处记录系统2000的状态。
当切割和缝合操作完成时,刀32可返回到预击发位置。由于仓34现已被击发,刀32可落入锁定凹坑2022,从而改变仓条件传感器2012的状态,并触发存储装置2001以在框2015处记录系统2000的状态。然后,可打开砧座24以清理组织。这可导致闭合触发器传感器2002、砧座闭合传感器2004和砧座闭合负荷传感器2006中的一个或多个改变状态,从而使系统2000的状态被记录在框2017处。组织被清理后,可在框2220处再次闭合砧座24。这将导致针对至少传感器2002和2004的另一状态改变,继而使存储装置2001在框2019处记录系统的状态。然后,在框2222处,器械10可从患者体内取出。
如果在同一过程中再次使用器械10,砧座可在框2224处打开,并在框2223处引发另一次系统状态记录。用过的仓34可在框2226处从端部执行器12移走。这将导致仓存在传感器2010改变状态,并导致在框2225处记录系统状态。另一仓34可在框2228处插入。这会导致仓存在传感器2010的状态改变,并在框2227处进行系统状态的记录。如果另一个仓34是新仓,则在判定块2230处指明,其插入也会导致仓条件传感器2012的状态改变。在这种情况下,系统状态可在框2231处被记录。
图53示出根据各种实施例的存储装置2001的示例性存储映射表2300。存储映射表2300包括一连串的列2302,2304,2306,2308,2310,2312,2314,2316和行(未标示)。列2302示出每一行的事件编号。其它列代表系统2000的一个传感器的输出。在给定时间记录的全部传感器读数可在相同的事件编号下记录在同一行中。因此,每一行代表一个实例,其中记录一个或多个来自系统2000的传感器的信号。
列2304列出在各个事件上记录的闭合负荷。这可反映出砧座闭合负荷传感器2006的输出。列2306列出击发冲程位置。这可源自刀位置传感器2008。例如,刀32的总行程可被分为几个分区。列2306中所列的数字可代表刀32当前所在的分区。列2308中列出了击发负荷。这可源自击发触发器传感器110。列2310列出了刀位置。与击发冲程类似,刀位置可源自刀位置传感器2008。列2312中可列出砧座24是打开还是闭合。该值可源自砧座闭合传感器2004和/或砧座闭合负荷传感器2006的输出。列2314可示出滑动件33是否存在或者仓34是否用完。这个值可源自仓条件传感器2012。最后,列2316可指示仓34是否存在。这个值可源于仓存在传感器2010。应当理解,各种其它值可存储在存储装置2001中,包括例如击发冲程的结束和开始,例如由传感器130,142所测。
图54和55示出了系统2000的另一个实施例。图54的所示实施例类似于图44的所示实施例,不同的是,在图54中传感器2002-2010与控制单元2400连通,该控制单元优选地位于器械的柄部6中,并且更优选地位于柄部6的手枪式握把部26中。控制单元2400可包括处理器2402和存储装置2001。存储装置2001可包括只读存储器单元2404和读写存储器单元2406。控制单元2400还可包括用于与传感器2002-2010连通的模数转换器(ADC)和数模转换器(DAC)(未示出)。只读存储器单元2404可包括EPROM和/或闪速EEPROM存储器单元。读写存储器单元2406可包括易失性存储器单元,例如随机存取存储器(RAM)单元。控制单元2400的各部件可为离散的,或其可集成于一个或几个部件中。例如,在一个实施例中,处理器2402、ROM2404、RAM2406、DAC和ADC可为微控制器或单片计算机的一部分。
控制单元2400可通过电源2408例如电池供电。对于具有用于驱动端部执行器的DC马达的器械10而言,驱动控制单元2400的电源2408可与驱动马达的电源相同,或者可用不同的电源来驱动控制单元2400和马达65。
来自各传感器的输出可以数字形式被存储到存储器单元2404,2406中的一者或二者中。公布的美国专利申请公布号2007/0175964A1公开了具有用于存储及记录传感器数据的存储装置的直线切割器,该专利申请全文以引用的方式并入本文。来自上述传感器中的一些传感器的输出可为模拟形式。对于这些类型的传感器,模数转换器(ADC)可用于将模拟传感器信号转换为数字形式以存储在存储器单元2404,2406中。另外,传感器可经由有线和/或无线通信链路联接到控制单元2400。例如,传感器与控制单元2400可经由单线或I2C总线来通信。针对传感器与控制单元2400无线通信的实施例,传感器可包括与控制单元2400的收发器(未示出)连通的转调器。
尽管未在图44中示出,器械10还可包括感测端部执行器的铰接状态的一个或多个铰接传感器。例如,铰接传感器可位于铰接枢轴中或靠近铰接枢轴,并且感测端部执行器12和轴8之间的相对铰接。铰接传感器还可与控制单元2400连通,并且来自铰接传感器的数据可被存储在控制单元2400的存储装置2001中。提交于2008年5月21日的名称为“SurgicalInstrument With Automatically Reconfigurable Articulating End Effector”的美国专利申请序列号12/124,655提供了更多关于此类铰接传感器的详细信息,该专利申请据此全文引入以供参考。此外,传感器可包括各种马达相关的传感器,该马达相关的传感器检测马达65的条件,例如RPM等。
根据各种实施例,存储在存储装置2001中的数据可被加密。例如,存储器单元2404,2406中的一者,例如ROM2404可存储加密代码或软件,该加密代码或软件在被处理器2402执行时使处理器2402对从传感器接收到的传感器数据进行加密,并且存储在存储装置2001中。
控制单元2400还可具有输出端口2020,远程计算机装置2420可经由连接至输出端口2020的通信链路2422从外部访问该输出端口。通信链路2422可为有线或无线通信链路。例如,输出端口2020可包括串行数据端口例如USB端口(包括类型A、类型B或迷你型-B USB端口)、IEEE1394接口(包括IEEE1394a,1394b或1394c)、RS-232端口、RS-423端口、RS-485端口、光口例如SONET或SDH端口、或用于有线串行数据通信链路2422的任何其它合适的串行数据端口。另外,通信链路2422可为平行数据通信链路,例如ISA、ATA、SCSI或PCI。在此类情况下,输出端口2020可为对应的平行数据输出端口。此外,通信链路2422可为无线数据链路,例如使用IEEE802.11标准之一的链路。
远程计算机装置2420可为具有处理器和存储器的任何装置,该装置能够与控制单元2400连通并且能够下载存储在存储装置2001中的传感器数据。例如,远程计算机装置2420可为台式计算机、膝上型计算机、服务器、工作站、掌上型计算机、小型计算机、可佩带式计算机等。远程计算机装置2420可在器械10的外部(即,并非器械10的一部分),并且在将数据下载至计算机装置2420时可相对靠近器械10,或者计算机装置2420可远离器械10,例如位于相邻的房间中或更远处。
图56为根据本发明的各种实施例的示出了流程的流程图。所述流程于步骤2500处开始,在该步骤处,临床医生使用器械10执行外科手术。在步骤2502处,器械中的各种传感器采集数据并且将其传输到控制单元2400。在步骤2504处,数据可被控制单元2400加密,并且在步骤2506处,被加密了的数据存储在存储器单元2001中。在其它实施例中,数据不需要被加密,或者感测到的数据的仅一部分被加密。然后在步骤2508处,数据链路在远程计算机装置2420与控制单元2400之间例如经由输出端口2020建立。然后在步骤2510处,存储在存储器单元2001中的一些或全部数据从传感器被下载至远程计算机装置2420。对于存储数据被加密的实施例而言,远程计算机装置2420可在数据被加载至远程计算机装置2420中的存储装置之前或之后对数据进行加密。在步骤2512处,现在存储在远程计算机装置2420中的数据可被调控。例如,可对数据进行计算或分析,或者其可被下载或传送至另一个存储介质。
本文公开的装置可被设计为在一次手术(其可包含多次击发)之后丢弃,或者它们可被设计为用于多次手术中。然而,无论在哪种情况下,都可对该装置进行再处理,以便在至少一次手术后再使用。重新恢复可包括如下步骤的任意组合:拆卸该装置、然后清洗或置换特定部分以及随后组装。特别是,所述装置可以拆卸,而且可以任意组合选择性地置换或移除该装置任意数目的特定零件或部分。清洗和/或置换特定部分后,该装置可以在修复设施处重新组装以便随后使用,或者在即将进行外科手术前由外科手术队重新组装。本领域的技术人员将会知道,装置的修复可利用多种用于拆卸、清洗/置换和重新组装的技术。这些技术的使用以及所得的修复装置均在本发明的范围内。
优选地,在外科手术之前将对本文所述的发明的各种实施例进行处理。首先,获取新的或用过的装置,并在必要时对装置进行清洁。然后对器械进行消毒。在一种消毒技术中,器械被布置在闭合和密封的容器内,例如由一层TYVEK覆盖的热成型塑料外壳。然后将容器和器械置于能够穿透该容器的辐射区,例如γ辐射、x-射线或高能电子。辐射将装置上和容器中的细菌杀死。然后将灭菌后的装置保存在无菌容器中。该密封容器将器械保持无菌,直到在医疗设备中打开该容器。
器械优选地经过消毒。这可通过本领域技术人员已知的任何数量的方法完成,包括β辐射或γ辐射、环氧乙烷、蒸汽以及其它方法。
上述发明还适用于机器人外科系统。此类系统在本领域中为人们所熟知,并且包括那些购自Intuitive Surgical,Inc.(Sunnyvale,CA)的系统。实例还公开于美国专利6,783,524、7,524,320和7,824,401中。所有上述专利据此以引用的方式并入本文。一般来讲,机器人外科系统具有远程可控用户界面和远程可控臂,该远程可控用户界面和远程可控臂能够与外科器械和系统交接并且操作外科器械和系统。臂可使用一个或多个电子控制系统来控制,该电子控制系统通常适于本地化控制台,以供用户与该本地化控制台交接。器械可由外科系统在本地提供动力,或具有与机器人总体控制相分离的动力系统。
机器人外科系统包括致动组件、监视器、机器人和附接到机械手臂的至少一个牢靠地附接的加载单元。该机械手臂具有至少一个外科器械以执行至少一项外科任务,并且该机械手臂能够可释放地附接到臂的远端。
在另一个实施例中,机器人外科系统包括处理器、至少一个编码器以确定至少一个马达驱动接头的位置、用于接收从缝合单元传输的电信号并且控制缝合单元的运动的接收器。
与机器人一起使用的示例性的一次性加载单元在授予Tovey等人的美国专利6,231,565中有所公开。能由外科医生比例控制的示例性外科机器人在授予Smith等人的美国专利5,624,398中有所公开。
在本发明的另一个方面中,机器人系统具有框架、相对于框架活动的机械手臂,以及具有细长管的缝合组件,该细长管将缝合组件连接至机械手臂。具有缝合组件的细长管和缝合组件自身这两者均可释放地附接到并且可操作地联接到机械手臂。缝合组件的一种构型可被移除,并且不同的构型可被附接并且被操作。
关于图4-5,机器人系统包括联接构件,该联接构件可释放地附接到闭合管40的近端并且径向联接到旋转驱动杆48的近端。接头还能够在容纳于顶盖271的内部之间的槽保持器46的近端内锁定,该顶盖还与槽保持器46交接。
虽然已经通过描述几个实施例举例说明了本发明并且已经相当详细地描述了示例性实施例,但是申请人不旨在将权利要求的范围约束或以任何方式限制到这些细节中。本领域的技术人员可容易看出其它优点和修改形式。本发明的各种实施例表示了相对于现有缝合方法的巨大改进,所述现有缝合方法需要使用一个仓中的不同尺寸的缝钉以实现具有不同成形(最终)高度的缝合。
因此,本发明对内窥镜式手术和设备进行了讨论。但是,本文使用的术语,例如“内窥镜式”不应被理解为将本发明限于仅结合内窥镜式管(即,插管或套管针)使用的外科手术缝合和切断器械。相反,应该相信本发明可用于进入受限的任何手术中,包括但不限于腹腔镜式手术以及开腹手术。此外,在不脱离本发明的实质和范围的情况下,本发明的各种钉仓的实施例的独特和新颖的方面当与其它形式的缝合设备结合使用时具有效用。
据述以引用方式全部或部分地并入本申请的任何专利、公布、或其它信息仅在所并入的材料不与本文所述的现有定义、陈述、或其它公开材料相冲突的程度下并入本申请。同样地,本申请明确阐述的公开内容取代了以引用的方式并入本申请的任何冲突材料。

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1.一种外科切割和紧固器械,包括:
a.端部执行器,所述端部执行器包括在其上具有缝钉成形结构的砧座、与所述砧座大体上相对以保持仓的外壳框架、保持能够随部署楔的远侧致动被驱动出所述仓的缝钉的可替换仓、以及至少一个传感器;
b.细长轴,所述轴具有在其中的可操作地联接到致动机构的马达,所述轴具有至少一个铰接接头,用于将所述仓以非平行于所述轴的纵向轴线的角度定位;
c.电联接的遥控致动控制台;
d.线性驱动运动转换器,所述线性驱动运动转换器将来自所述马达的旋转运动转换成线性运动。
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