CN103402444A - 在控制单元与遥感器之间具有无线通信的外科器械 - Google Patents

在控制单元与遥感器之间具有无线通信的外科器械 Download PDF

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CN103402444A
CN103402444A CN2012800110621A CN201280011062A CN103402444A CN 103402444 A CN103402444 A CN 103402444A CN 2012800110621 A CN2012800110621 A CN 2012800110621A CN 201280011062 A CN201280011062 A CN 201280011062A CN 103402444 A CN103402444 A CN 103402444A
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F·E·谢尔顿四世
J·S·斯韦兹
J·R·乔达诺
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Abstract

本发明公开了一种外科器械(10),其包括具有至少一个传感器(368)的端部执行器(12)。该器械包括远侧缝合单元,该远侧缝合单元用于执行操作地连接至远程可控用户界面的至少一个外科任务。该器械还包括导电轴(8),该导电轴具有连接至端部执行器的远端,其中传感器与轴电绝缘。该器械还包括在轴的近端处的外壳(6),该外壳能够容纳机械输入或电气输入。此外,该器械还具有与轴电绝缘的接收器单元(300),该接收器单元能够从传感器接收无线信号和向传感器发送无线信号。

Description

在控制单元与遥感器之间具有无线通信的外科器械
相关专利申请的交叉引用
该部分继续申请要求2007年1月10日提交的名称为“SurgicalInstrument with Wireless Communication between Control Unit and RemoteSensor”的美国专利申请11/651,807的权益,并涉及下列同时提交的美国专利申请,其以引用的方式并入本文:
(1)由J.Giordano等人提交的名称为“SURGICAL INSTRUMENTWITH WIRELESS COMMUNICATION BETWEEN CONTROLUNIT AND SENSOR TRANSPONDERS”的美国专利申请序列号11/651,715(代理人案卷号060338/END5923USNP);
(2)由J.Giordano等人提交的名称为“SURGICAL INSTRUMENTWITH ELEMENTS TO COMMUNICATE BETWEEN CONTROLUNIT AND END EFFECTOR”的美国专利申请序列号11/651,806(代理人案卷号060340/END5925USNP);
(3)由F.Shelton等人提交的名称为“PREVENTION OF CARTRIDGEREUSE IN A SURGICAL INSTRUMENT”的美国专利申请序列号11/651,768,其美国专利号为7,721,931,公布于2010年5月25日(代理人案卷号060341/END5926USNP);
(4)由J.Swayze等人提交的名称为“POST-STERILIZATIONPROGRAMMING OF SURGICAL INSTRUMENTS”的美国专利申请序列号11/651,807(代理人案卷号060342/END5924USNP);
(5)由F.Shelton等人提交的名称为“INTERLOCK AND SURGICALINSTRUMENT INCLUDING SAME”的美国专利申请序列号11/651,788;其美国专利号为7,721,936,公布于2010年5月25日(代理人案卷号060343/END5928USNP);和
(6)由F.Shelton等人提交的名称为“SURGICAL INSTRUMENTWITH ENHANCED BATTERY PERFORMANCE”的美国专利申请序列号11/651,785(代理人案卷号060347/END5931USNP)。
背景技术
内窥镜式外科器械常常优于传统的开放式外科装置,因为较小的切口往往会减少术后恢复时间和并发症。因此,已对适用于将端部执行器穿过套管针的插管精确地设置在所需外科手术部位处的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,并且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。钳口构件中的一者容纳钉仓,该钉仓具有侧向间隔开的至少两排缝钉。另一钳口构件限定砧座,所述砧座具有与钉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,以在击发之前将组织定位。一旦临床医生已确定钳口构件正确地夹住了组织,临床医生然后可使用单击发冲程击发外科缝合器,从而切断并缝合组织。同时切断和缝合避免了当利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,临床医生可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,相对的钳口可能被拉得太近,特别是在它们的远端夹拢,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能导致束缚和不完全击发。
每一代内镜缝合器/切割器都在复杂性方面不断增加和功能方面不断增强。这种情形的主要原因中的一个在于追求将击发力(FTF)降低到所有的或大多数的外科医生均可操控的程度。降低FTF的一种已知解决方案是使用CO2或电动马达。这些装置并不比传统的手动装置强多少,但是理由不同。外科医生通常更愿意体验与在使缝钉成形时由端部执行器所受的力成比例的力分布,以确保在大多数外科医生能力的上限(通常为约15-30lbs)内完成切割/缝合循环。如果外科医生在装置柄部中感受到的力过大或由于一些其它临床原因,他们通常还希望保持对缝钉部署的控制并能够随时停止。
为了解决这个需要,所谓的“动力辅助”内窥镜式外科器械已经得到了开发,其中补充电源辅助器械的击发。例如,在一些动力辅助装置中,马达向由使用者通过挤压击发触发器而输入的动力提供补充电力。此类装置能够向操作者提供加载力反馈和控制,以减少操作者为了完成切割操作而所需施加的击发力。一种此类动力辅助装置在由Shelton等人于2006年1月31日提交的名称为“Motor-driven surgical cutting and fastening instrumentwith loading force feedback”的美国专利申请序列号11/343,573(“所述‘573专利申请”)中有所描述,其以引用的方式并入本文。
这些动力辅助装置常常包括其它部件,例如传感器和控制系统,所述其它部件是纯机械内窥镜式外科器械所不包括的。在外科器械中使用此类电子器件的一个挑战是向或从传感器传送动力和/或数据,尤其是当外科器械中存在自由的旋转接头时。
发明内容
在一个总体方面,本发明涉及外科器械,例如内窥镜式或腹腔镜式器械。根据一个实施例,外科器械包括端部执行器,该端部执行器包括无源供能的至少一个传感器转发器。外科器械还包括轴和柄部,所述轴的远端连接至端部执行器,所述柄部连接至该轴的近端。柄部包括通过至少一个电感耦接头与传感器转发器通信的控制单元(例如,微控制器)。另外,外科器械还可包括用于旋转该轴的旋转接头。在这种情况下,外科器械可包括第一感应元件和第二感应元件。第一感应元件位于旋转接头远侧的轴中并感应耦合至控制单元,第二感应元件位于轴的远侧并感应耦合至至少一个传感器转发器。第一感应元件和第二感应元件可由有线的物理连接部连接。
这样的话,控制单元可与端部执行器中的转发器通信而无需通过复杂的机械接头如旋转接头的直接有线连接,在这些地方难以保持此类有线连接。此外,由于感应元件之间的距离可以是固定的和已知的,因此可最优化耦接件以用于能量的感应转移。此外,距离可相对较短,使得相对较低的功率信号可用于最小化在器械的使用环境中对其它系统的干涉作用。
在本发明的另一总体方面,外科器械的导电轴可作为用于控制单元的天线以向或从传感器转发器无线传输信号。例如,传感器转发器可位于或设置在端部执行器的非导电部件例如塑料仓上,从而使传感器与端部执行器及轴的导电部件绝缘。此外,柄部中的控制单元可电联接至轴。从而,轴和/或端部执行器可通过从控制单元向传感器发射信号和/或通过从传感器接收所发射的信号来作为用于控制单元的天线。这样的设计尤其适用于具有复杂的机械接头(诸如旋转接头)的外科器械,而复杂的机械接头导致难以在传感器和控制单元之间使用直接有线连接来传输数据信号。
在另一个实施例中,轴和/或端部执行器的部件可通过向控制单元发射信号以及从控制单元接收所发射的信号来作为用于传感器的天线。根据此类实施例,控制单元与轴及端部执行器电绝缘。
在另一总体方面,本发明涉及包括可编程控制单元的外科器械,该可编程控制单元可在器械已被包装并消毒后由编程装置编程。在一个这样的实施例中,编程装置可对控制单元无线编程。控制单元在编程操作期间可由来自编程装置的无线信号无源供能。在另一个实施例中,无菌容器可包括连接接口,使得编程单元可在外科器械处于其消毒容器中时被连接至外科器械。
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是根据本发明的各种实施例的外科器械的透视图;
图3-5是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是根据本发明的各种实施例的端部执行器的侧视图;
图7是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是根据本发明的各种实施例的柄部的局部透视图;
图10是根据本发明的各种实施例的柄部的侧视图;
图11、13-14、16和22是根据本发明的各种实施例的外科器械的透视图;
图12和19是根据本发明的各种实施例的控制单元的方框图;
图15是根据本发明的各种实施例的包括传感器转发器在内的端部执行器的侧视图;
图17和18示出了根据本发明的各种实施例的无菌容器中的器械;
图20是根据本发明的各种实施例的远程编程装置的方框图;并且
图21是根据本发明的各种实施例的包装器械的图示。
具体实施方式
本发明的各种实施例一般来讲涉及外科器械,该外科器械具有至少一个遥感器转发器以及用于将动力和/或数据信号从控制单元传输至一个或多个转发器的装置。本发明可用于包括至少一个传感器转发器的任何类型的外科器械,例如内窥镜式或腹腔镜式外科器械,但尤其可用于以下外科器械,其中该器械的一些结构诸如自由旋转接头阻止或换句话讲抑制对一个或多个传感器使用有线连接。在描述系统的各方面之前,首先以举例说明的方式描述一种类型的外科器械(其中可使用本发明的实施例),内窥镜式缝合和切割器械(例如,直线切割器)。
图1和图2示出了一种内窥镜式外科器械10,其包括柄部6、轴8和在关节枢轴14处枢转地连接至轴8的关节连接端部执行器12。柄部6上的控件可有利于端部执行器12的正确放置和取向,所述控件包括(1)旋转旋钮28,其用于在轴8的自由旋转接头29处旋转所述闭合管(在下文结合图4-5更详细地描述)从而旋转端部执行器12,和(2)关节控件16,其围绕关节枢轴14来对端部执行器12进行旋转关节连接。在示出的实施例中,端部执行器12能够充当直线切割器以夹持、切断和缝合组织,尽管在其它实施例中,可使用不同类型的端部执行器,例如用于其它类型的外科器械(例如,抓紧器、切割器、缝合器、施夹钳、进入装置、药物/基因治疗装置、超声、射频或激光装置等)的端部执行器。
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其它合适的控件。端部执行器12被显示为优选地通过伸长轴8与柄部6分离。在一个实施例中,器械10的临床医生或操作者可通过利用关节控件16使端部执行器12相对于轴8关节来连接,如在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”的未决的美国专利申请序列号11/329,020中更详细地描述,该专利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包括缝钉槽22和可枢转地平移的夹紧构件,例如砧座24,其以确保有效地缝合和切断被夹持在端部执行器12中的组织的间隔来保持。柄部6包括手枪式握把26,临床医生将闭合触发器18可枢转地朝手枪式握把26拉动,以使砧座24朝向端部执行器12的缝钉槽22夹紧或闭合,从而夹紧位于砧座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。一旦闭合触发器18被锁定在关闭位置,击发触发器20就可朝着手枪式握把26轻微旋转以使其可由操作者用一只手触及。然后,操作者可将击发触发器20朝着手枪式握把12可枢转地拉动以缝合和切断端部执行器12中夹持的组织。‘573专利申请描述了用于锁定和解锁闭合触发器18的各种构型。在其它实施例中,可使用除砧座24之外的不同类型的夹紧构件,例如相对的钳口等。
应当理解,本申请使用的术语“近侧”和“远侧”是相对于握持器械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,也并非是绝对的。
可首先致动闭合触发器18。一旦临床医生对于端部执行器12的定位感到满意,临床医生即可将闭合触发器18拉回至其紧邻手枪式握把26的完全闭合的锁定位置。然后,可致动击发触发器20。当临床医生去除压力时,击发触发器20返回至打开位置(如图1和图2所示)。位于柄部6上并且在此例子中位于柄部的手枪式握把26上的释放按钮30在被压下时可释放锁定的闭合触发器18。
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还可包括切割器32、滑动件33、可移除地安装在槽22中的钉仓34、和螺旋状螺杆轴36。例如,切割器械32可为刀。砧座24可在连接至槽22的近端的枢转点25处可枢转地打开和闭合。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)的部件中以打开和闭合砧座24。当致动(即通过器械10的使用者拉动)闭合触发器18时,砧座24可围绕枢转点25枢转至夹紧或闭合位置。如果对端部执行器12的夹紧感到满意,则操作者可致动击发触发器20,这将如下文更详细地所述使刀32和滑动件33沿槽22纵向行进,从而切割被夹持在端部执行器12内的组织。滑动件33沿着槽22的运动使得钉仓34的缝钉被驱动穿过被切断的组织并且抵靠闭合的砧座24,该砧座24转动缝钉以紧固被切断的组织。名称为“Surgical stapling instrument incorporating an E-beam firing mechanism”的美国专利6,978,921提供了关于此类双冲程切割和紧固器械的更多细节,该专利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。槽22和砧座24可由导电材料(诸如金属)制成,使得它们可作为与端部执行器中的一个或多个传感器通信的天线的一部分,如下文进一步所述。仓34可由非导电材料(诸如塑料)制成,并且传感器可被连接至仓34或被设置在仓34内,如下文进一步所述。
应该指出的是,虽然本文描述的器械10的实施例使用用于缝合被切断的组织的端部执行器12,但是在其它实施例中,也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合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 Recessed And/Or Offset Electrodes”的美国专利5,688,270公开了使用射频能量来紧固被切断的组织的切割器械,该专利以引用的方式并入本文。授予Morgan等人的美国专利申请序列号11/267,811以及授予Shelton等人的美国专利申请序列号11/267,363公开了使用粘接剂来紧固被切断的组织的切割器械,该专利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,并不旨在进行限制。也可使用其它组织紧固技术。
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。如图示实施例中所示,轴8可包括由枢轴连接件44可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,其中砧座24上的突出部27插入开口45中以打开和闭合砧座24。近侧脊管46可设置在闭合管40,42内。主旋转(或近侧)传动轴48通过锥齿轮组件52与次(或远侧)传动轴50连通并可设置在近侧脊管46内。次传动轴50连接至与螺旋状螺杆轴36的近侧传动齿轮56接合的传动齿轮54。立式锥齿轮52b可座于位于近侧脊管46远端的开口57中且可在其中枢转。远侧脊管58可用来包封次传动轴50和传动齿轮54、56。在本文中有时将主驱动轴48、次驱动轴50和关节组件(例如锥齿轮组件52a-c)统称为“主驱动轴组件”。闭合管40,42可由导电材料(诸如金属)制成,使得它们可作为天线的一部分,如下文进一步所述。主驱动轴组件(例如,驱动轴48,50)的部件可由非导电材料(诸如塑料)制成。
定位在缝钉槽22远端处的轴承38容纳螺杆传动轴36,从而允许螺杆传动轴36可相对于槽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的旋转导致刀32(根据旋转方向)朝远侧或近侧平移穿过缝钉槽22。因此,当通过致动击发触发器20而导致主驱动轴48旋转时(如下文更详细地说明),锥齿轮组件52a-c使次驱动轴50旋转,继而由于传动齿轮54,56的接合,使得螺旋状螺杆轴36旋转,这使刀32沿着槽22纵向行进,以切割夹持在端部执行器内的任何组织。滑动件33可由例如塑料制成,并且可具有倾斜的远侧表面。当滑动件33横贯槽22时,前倾表面可向上推动或驱动钉仓34中的缝钉穿过被夹紧的组织,并撞击到砧座24。砧座24使缝钉弯折,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。
根据各种实施例,如图7-10所示,外科器械可在柄部6中包括电池64。示出的实施例提供关于端部执行器12中切割器械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18时提供的动力来对器械10供能(所谓的“动力辅助”模式)。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。柄部件59-62可由非导电材料诸如塑料制成。电池64可设在柄部6的手枪式握把部26中。电池64对设置在柄部6的手枪式握把26上部内的电机65供能。电池64可根据任何合适的构造或化学组成构造,例如锂离子化学组成诸如LiCoO2或LiNiO2,镍金属氢化物化学组成等。根据各种实施例,马达65可为具有大约5000RPM至100,000RPM的最大转速的DC有刷驱动马达。电机64可驱动90°锥齿轮组件66,该锥齿轮组件包括第一锥齿轮68和第二锥齿轮70。锥齿轮组件66可驱动行星齿轮组件72。行星齿轮组件72可包括连接至传动轴76的小齿轮74。小齿轮74可驱动配对的环形齿轮78,该环形齿轮通过传动轴82来驱动螺旋齿轮鼓80。环84可螺旋接合在螺旋齿轮鼓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连通的马达运转传感器110,其检测击发触发器20何时被操作者朝向柄部6的手枪式握把部分26拉回(或“闭合”),从而致动端部执行器12的切割/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检测到该活动并发出电信号,该电信号指示要供给马达65的电压(或功率)。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的活动量大致成比例。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上的电压就越大,从而转速就越大。在另一个实施例中,例如,控制单元(下文进一步描述)可根据来自传感器110的输入来向马达65输出PWM控制信号以便控制马达65。
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上的柱与击发触发器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,使用者即可停止端部执行器12的部署,从而为操作者提供对切割/紧固操作进行控制的方式。
螺旋齿轮鼓80的远端包括驱动环形齿轮122的远侧传动轴120,所述环形齿轮122与小齿轮124配合。小齿轮124连接至主传动轴组件的主传动轴48。这样,马达65的旋转使得主传动轴组件旋转,从而致动端部执行器12,如上所述。
螺纹地接合在螺旋齿轮鼓80上的环84可包括设置在开槽臂90的槽88内的柱86。开槽臂90在其相对末端94处具有开口92,该开口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。
另外,柄部6可包括反向马达(或行程结束传感器)130和止动马达(或行程开始)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在被启动时向控制单元发送信号,控制单元向马达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,当器械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的部署并向控制单元发送信号,控制单元向马达65发送信号以使马达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齿轮组件72的远端处的环形齿轮78旋转,从而使得螺旋形齿轮鼓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传动轴组件,这继而部署端部执行器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向控制单元发送信号,控制单元向马达65发送信号以使马达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接合的后侧肩部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的前移止挡件107。如以上所解释,开槽臂90的运动受马达65旋转的控制。当随着环84从螺旋形齿轮鼓80的近端朝远端行进,开槽臂90逆时针旋转时,中间柄部件104将自由地逆时针旋转。因此,当使用者将击发触发器20拉回时,击发触发器20将与中间柄部件104的前移止挡件107接合,使得中间柄部件104逆时针旋转。然而,由于后侧肩部106接合开槽臂90,因此中间柄部件104仅在开槽臂90允许的情况下才能够逆时针旋转。这样,如果马达65由于某种原因应该停止旋转,那么开槽臂90将停止旋转,使用者将无法进一步拉回击发触发器20,因为中间柄部件104由于开槽臂90而无法逆时针旋转。
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的砧板24的示例性闭合系统的部件。在图示实施例中,闭合系统包括轭250,该轭通过穿过闭合触发器18和轭250中的对齐的开口插入的销251连接至闭合触发器18。闭合触发器18围绕枢轴销252枢转,并且枢轴销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的回缩使得通过销251附接到轭250的闭合触发器18的上部逆时针旋转。轭250的远端通过销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,而近侧闭合管40(见图4)的近端座置和保持在该开口中,使得闭合托架256、258的纵向活动引起近侧闭合管40的纵向活动。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可包括窗口261,而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设置在该窗口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还可包括远侧衬圈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的拉回而旋转时,所述封闭托架256、258使得近侧封闭管40朝远侧(即远离器械10的手柄端)运动,从而使得远侧封闭管42朝远侧运动,继而使得砧座24绕枢转点25旋转至夹紧或闭合位置。当闭合触发器18从锁定位置解锁时,近侧封闭管40朝近侧滑动,从而使得远侧封闭管42朝近侧滑动,继而利用插入远侧封闭管42的窗口45中的突出部27使得砧座24绕枢转点25枢转至打开或未夹紧位置。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18从锁定位置解锁来松开该组织。
控制单元(下文进一步描述)可接收来自行程结束传感器130和行程开始传感器142以及马达运行传感器110的输出,并可基于输入来控制马达65。例如,当操作者在锁定闭合触发器18之后开始牵拉击发触发器20时,马达运行传感器110被致动。如果钉仓34存在于端部执行器12中,则钉仓闭锁传感器(未示出)可被关闭;在这种情况下,控制单元可向马达65输出控制信号以导致马达65正向旋转。当端部执行器12行程结束时,反向马达传感器130将被启动。控制单元可从反向马达传感器130接收该输出并导致马达65的旋转方向反向。当刀32完全回缩时,止动马达传感器开关142被启动,导致控制单元使马达65停止。
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与齿轮传动系啮合,因此操作者仍将感受到力反馈。
马达10可在端部执行器12中包括许多用于感测与端部执行器12相关的各种状态的传感器转发器,例如用于确定钉仓34的状态的传感器转发器(或根据外科器械的类型的其它类型的仓),在闭合和击发期间缝合器的进度等。传感器转发器可由感应信号无源供能,如下文进一步所述,但是在其它实施例中转发器可由远程电源例如诸如端部执行器12中的电池供能。一个或多个传感器转发器例如可包括磁阻传感器、光学传感器、机电传感器、RFID传感器、MEMS传感器、运动传感器或压力传感器。这些传感器转发器可与控制单元300通信,控制单元可容纳在器械10的柄部6中,例如图11所示。
如图12所示,根据各种实施例,控制单元300可包括处理器306和一个或多个存储器单元308。通过执行储存在存储器308中的指令码,基于从各种端部执行器传感器转发器以及其它一种或多种传感器(例如诸如马达运行传感器110、行程结束传感器130和行程开始传感器142)接收的输入,处理器306可控制器械10的各种部件,例如马达65或用户显示器(未示出)。控制单元300在器械10的外科使用期间由电池64供能。控制单元300可包括感应元件302(例如,线圈或天线)以从传感器转发器获得无线信号,如下文更详细描述。由作为接收天线的感应元件302接收的输入信号可由解调器310解调并由解码器312解码。输入信号可包括来自端部执行器12中的传感器转发器的数据,而处理器306可使用该数据来控制器械10的各个方面。
为了向传感器转发器传输信号,控制单元300可包括用于将信号编码的编码器316和用于根据调制方案来调节信号的调制器318。感应元件302可作为传输天线。控制单元300可使用任何合适的无线通信协议和任何合适的频率(例如ISM频段)与传感器转发器通信。并且,控制单元300可在与从传感器转发器接收到的信号的频率范围不同的频率范围内传输信号。并且,虽然只有一个天线(感应元件302)示出于图12中,但在其它实施例中,控制单元300可具有单独的接收和传输天线。
根据各种实施例,控制单元300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(例如射频接收器和PWM控制器)、和/或离散的无源部件。控制单元例如也可表现为片上系统(SoC)或系统级封装(SIP)。
如图11所示,控制单元300可容纳在器械10的柄部6中,并且用于器械10的一个或多个传感器转发器368可位于端部执行器12中。为了向或从端部执行器12中的传感器转发器368递送电力和/或传输数据,控制单元300的感应元件302可感应耦合至定位在旋转接头29远侧的轴8中的次感应元件(例如,线圈)320。次感应元件320优选地与导电轴8电绝缘。
次感应元件320可通过导电的绝缘电线322连接至远侧感应元件(例如线圈)324,所述感应元件324位于端部执行器12附近,并且优选地位于相对于关节枢轴14的远侧。电线322可由导电的聚合物或金属(例如铜)制成并且可为足够柔性的,以便其可穿过关节枢轴14而不被关节损坏。远侧感应元件324可感应耦合至位于例如端部执行器12的仓34中的传感器转发器368。如下文所详述,转发器368可包括用于感应耦合至远侧线圈324的天线(或线圈)、用于接收和传输无线通信信号的传感器和集成控制电子器件。
转发器368可使用从远侧感应元件326接收的感应信号的动力的一部分为转发器368无源供能。一旦由感应信号足够地供能,则转发器368可经由(i)介于转发器368和远侧感应元件324之间的电感耦接头,(ii)电线322,和(iii)介于次感应元件320和控制单元300之间的电感耦接头,来接收数据并将数据传输至柄部6中的控制单元300。从而,控制单元300可与端部执行器12中的转发器368通信而无需通过复杂的机械接头如旋转接头29的直接有线连接和/或无需从轴8到端部执行器12的直接有线连接,在这些地方难以保持此类有线连接。此外,由于介于感应元件之间的距离(例如,介于(i)转发器368和远侧感应元件324之间,和(ii)次感应元件320和控制单元300之间的间距)是固定且已知的,因此可最优化耦接头以用于能量的感应转移。并且,距离可相对较短,使得相对较低的功率信号因此可用于最小化在器械10的使用环境中对其它系统的干涉。
在图12的实施例中,控制单元300的感应元件302相对地靠近控制单元300来定位。根据其它实施例,如图13所示,控制单元300的感应元件302可被定位成更靠近旋转接头29,那样其便更靠近次感应元件320,从而减小电感耦接头在此类实施例中的距离。作为另外一种选择,控制单元300(并且因此感应元件302)可更靠近次感应元件320来定位以减小间距。
在其它实施例中,可使用两个以上或两个以下的电感耦接头。例如,在一些实施例中,外科器械10可使用介于柄部6中的控制单元300与端部执行器12中的转发器368之间的单个电感耦接头,从而消除了感应元件320,324以及电线322。当然,在此类实施例中,由于介于柄部6中的控制单元300与端部执行器12中的转发器368之间的距离更大,因此可能需要更强的信号。并且可使用多于两个的电感耦接头。例如,如果外科器械10具有很多复杂的机械接头,而在该机械接头处难以保持直接有线连接,则可使用电感耦接头来跨越每个此类接头。例如,可在旋转接头29的两侧上以及关节枢轴14的两侧上使用电感耦合器,其中旋转接头29的远侧上的感应元件321由线322连接至关节枢轴的近侧的感应元件324,并且电线323连接关节枢轴14的远侧上的感应元件325,326,如图14所示。在该实施例中,感应元件326可与传感器转发器368通信。
此外,转发器368可包括许多不同的传感器。例如,其可包括一系列传感器。另外,端部执行器12可包括与远侧感应元件324(并且因此控制单元300)通信的许多传感器转发器368。并且,感应元件320,324可包括或不包括铁氧体磁芯。如前所述,它们也优选地与器械10(例如闭合管40,42)的导电的外轴(或框架)绝缘,并且电线322也优选地与外轴8绝缘。
图15是端部执行器12的图示,包括保持或嵌入在槽22的远端处的仓34中的转发器368。转发器368可通过合适的粘结材料例如环氧化物连接至仓34。在该实施例中,转发器368包括磁阻传感器。砧座24在其远端处也包括永磁体369并通常面向转发器368。在该示例性实施例中,端部执行器12也包括连接至滑动件33的永磁体370。这将允许转发器368检测端部执行器12的打开/闭合(由于当砧座24打开和闭合时永磁体369靠近或远离转发器运动)以及缝合/切割操作的完成(由于当滑动件33横贯所述槽22作为切割操作的一部分时,永磁体370朝向转发器368运动)。
图15也示出了钉仓34的缝钉380和缝钉驱动器382。如前所述,根据各种实施例,当滑动件33横贯所述槽22时,滑动件33驱动缝钉驱动器382,该缝钉驱动器将缝钉380驱动进入保持在端部执行器12中的切断的组织中,其中缝钉380抵靠砧座24形成。如上所述,此类外科切割和紧固器械仅仅是本发明可有利地采用的一种类型的外科器械。本发明的各种实施例可用于具有一种或多种传感器转发器的任何类型的外科器械中。
在如上所述的实施例中,电池64为器械10的击发操作(至少部分地)供能。同样,器械可以是所谓的“动力辅助”装置。动力辅助装置的更详细的信息和附加实施例描述于并入本文中的‘573专利申请中。然而,应当认识到,器械10不需要动力辅助装置,并且这仅仅是可利用本发明的方面的装置的类型的例子。例如,器械10可包括由电池64供能且由控制单元300控制的用户显示器(诸如LCD或LED显示器)。得自端部执行器12中的传感器转发器368的数据可显示在这样的显示器上。
在另一个实施例中,器械10的轴8,包括例如近侧闭合管40和远侧闭合管42,通过向传感器转发器368发射信号以及从传感器转发器368接收所发射的信号,可共同作为用于控制单元300的天线的一部分。从而,至或来自端部执行器12中的遥感器的信号可经由器械10的轴8传输。
近侧闭合管40可通过外部下侧件和外部上侧件59-62在其近端处接地,其可由非导电材料例如塑料制成。近侧闭合管40和远侧闭合管42内部的驱动轴组件部件(包括主驱动轴48和次驱动轴50)也可由非导电材料例如塑料制成。另外,端部执行器12(诸如砧座24和槽22)的部件可电联接至(或直接或间接电接触)远侧闭合管42,使得它们也可作为天线的一部分。另外,传感器转发器368可被定位成使得其与作为天线的轴8以及端部执行器12的不同部件电绝缘。例如,传感器转发器368可定位在仓34中,其可由非导电材料例如塑料制成。由于作为天线的轴8的远端(诸如远侧闭合管42的远端)以及端部执行器12的不同部分距传感器368的距离可相对较近,因此用于传输的信号的动力可保持在低水平,从而最小化或减小在器械10的使用环境中对其它系统的干涉。
在此类实施例中,如图16所示,控制单元300可通过导电联接件400(例如电线)电联接至器械10的轴8,例如联接至近侧闭合管40。因此,外轴8的不同部分例如闭合管40,42可通过向传感器368发射信号以及从传感器368接收所发射的信号来作为用于控制单元300的天线的一部分。由控制单元300接收的控制信号可由解调器310解调并由解码器312解码(见图12)。输入信号可包括来自端部执行器12中的传感器368的数据;处理器306可使用该数据来控制器械10的各个方面,诸如马达65或用户显示器。
为了向或从端部执行器12中的传感器368传输数据信号,联接件400可将控制单元300连接至器械10的轴8的部件,诸如近侧闭合管40,其可电连接至远侧闭合管42。远侧闭合管42优选地与可定位在塑料仓34(见图3)中的遥感器368电绝缘。如上所述,端部执行器12的部件诸如槽22和砧座24(见图3)可导电并与远侧闭合管42电接触,使得它们也可作为天线的一部分。
在轴8作为用于控制单元300的天线的情况下,控制单元300可与端部执行器12中的传感器368通信而无需直接有线连接。此外,由于轴8和遥感器368之间的距离是固定且已知的,因此功率水平可被最优化至低水平,从而最小化在器械10的使用环境中对其它系统的干涉。传感器368可包括用于向控制单元300发射信号以及用于从控制单元300接收信号的通信电路,如上所述。该通信电路可与传感器368集成。
在另一个实施例中,轴8的和/或端部执行器12的不同部件可作为用于遥感器368的天线。在此类实施例中,遥感器368电连接至轴(诸如远侧闭合管42,其可电连接至近侧闭合管40),并且控制单元300与轴8绝缘。例如,传感器368可被连接至端部执行器12的导电部件(诸如槽22),其继而可被连接至轴的导电部件(例如,闭合管40,42)。作为另外一种选择,端部执行器12可包括连接遥感器368和远侧闭合管42的电线(未示出)。
通常,外科器械诸如器械10在使用之前要进行清洁和消毒。在一种消毒技术中,器械10被放置在闭合和密封的容器280诸如塑料或TYVEK容器或袋中,如图17和18所示。然后将容器和器械置于可穿透该容器的辐射区,诸如γ辐射、x-射线或高能电子。辐射杀死器械10上和容器280中的细菌。然后将灭菌后的器械10储存在无菌容器280中该密封的无菌容器280使器械10保持无菌,直到在医疗设施中或一些其它使用环境中打开该容器。代替辐射,也可使用其它手段来为器械10消毒,诸如环氧乙烷或蒸汽。
当使用辐射诸如γ辐射来为器械10消毒时,控制单元300的不同部件,尤其是存储器308和处理器306,可被损坏并变得不稳定。因此,根据本发明的各种实施例,可在器械10被包装和消毒后对控制单元300编程。
如图17所示,远程编程装置320可与控制单元300无线通信,所述远程编程装置320可为手持式装置。远程编程装置320可发射无线信号,该无线信号被控制单元300接收从而对控制单元300编程以及在编程操作期间为控制单元300供能。从而,电池64在编程操作期间无需为控制单元300供能。根据各种实施例,下载到控制单元300的程序码可相对较小,诸如1MB或更小,使得如果需要的话,可使用具有较低的数据传输速率的通信协议。并且,可使远程编程单元320与外科器械10紧密地物理接近,以便可使用低功率信号。
重新参见图19,控制单元300可包括感应线圈402以便从远程编程装置320获得无线信号。接收到的信号的一部分可由电源电路404使用,以在电池64不供能时为控制单元300供能。
作为接收天线的线圈402所接收到的输入信号可由解调器410解调并由解码器412解码。输入信号可包括编程指令(例如代码),所述编程指令可储存在存储器308的非易失性存储器部分中。当器械10运行时,处理器306可执行代码。例如,代码可导致处理器306基于从传感器368接收到的数据向器械10的各种子系统诸如马达65输出控制信号。
控制单元300也可包括非易失性存储器单元414,该非易失性存储器单元包括由处理器306执行的引导顺序码。当控制单元300在灭菌后的编程操作期间从来自远程控制单元320的信号接收到足够的动力时,处理器306可第一次执行该引导顺序码(“引导装载程序”)414,这可为处理器306加载操作系统。
控制单元300也可将信号发送回该远程编程单元320,例如诸如确认信号和握手信号。控制单元300可包括用于将信号进行编码然后发送至编程装置320的编码器416,以及用于根据调制方案来调节信号的调制器418。线圈402可作为传输天线。控制单元300和远程编程装置320可使用任何合适的无线通信协议(例如,蓝牙)以及任何合适的频率(例如,ISM频段)进行通信。并且,控制单元300可在与从远程编程单元320接收到的信号的频率范围不同的频率范围内传输信号。
图20是根据本发明的各种实施例的远程编程装置320的简化图。如图20所示,远程编程单元320可包括主控板230和升压天线板232。主控板230可包括控制器234、电源模块236和存储器238。存储器238可储存控制器234的操作指令以及将被传输至外科器械10的控制单元300的编程指令。电源模块236可由内置电池(未示出)或外部交流或直流电源(未示出)为远程编程装置320的不同部件提供稳定的直流电压。
升压天线板232可包括耦合电路240,该耦合电路例如经由I2C总线与控制器234通信。耦合电路240可经由天线244与外科器械的控制单元300通信。耦合电路240可处理调节/解调以及编码/解码操作来用于控制单元的传输。根据其它实施例,远程编程装置320可具有离散的调制器、解调器、编码器和解码器。如图20所示,升压天线板232也可包括传输功率放大器246、用于天线244的匹配电路248和用于接收信号的过滤器/放大器249。
根据其它实施例,如图20所示,远程编程装置可经由例如USB和/或RS232接口与计算机装置460诸如PC或便携式电脑通信。在此类构型中,计算装置460的存储器可储存待传输至控制单元300的编程指令。在另一个实施例中,计算装置460可配置有无线传输系统以将编程指令传输至控制单元300。
此外,根据其它实施例,可使用电容耦合,而不是使用介于控制单元300和远程编程装置320之间的电感耦接头。在此类实施例中,控制单元300可具有板而不是线圈,远程编程单元320也是如此。
在另一个实施例中,不使用控制单元300与远程编程装置320之间的无线通信链路,编程装置320可在器械10处于其无菌容器280中时物理连接至控制单元300,使得器械10可保持灭菌。图21是根据此类实施例的包装的器械10的图示。如图22所示,器械10的柄部6可包括外部连接接口470。容器280可还包括连接接口472。当器械10被包装在容器280中时,该连接接口472与器械10的外部连接接口470配合。编程装置320可包括可在容器280的外部处连接至连接接口472的外部连接接口(未示出),从而提供介于器械10的编程装置320与外部连接接口470之间的有线连接。
上述发明还适用于机器人外科系统。此类系统在本领域为人们所熟知,并且包括购自Intuitive Surgical,Inc.(Sunnyvale,CA.)的那些。例子也公开于美国专利6,783,524;7,524,320;和7,824,401中。所有专利均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包括远程可控臂的远程可控用户界面,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能够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、和附接到机械臂的至少一个牢靠地附接的加载单元,所述机械臂具有至少一个外科器械以执行至少一项外科任务,并且该外科器械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其运动的接收器。
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。具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臂,并且具有细长管的缝合组件,该细长管将缝合组件连接至机械臂。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操作地联接至机械臂。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至旋转驱动杆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,该接头还与槽保持器46交接。
以上已经结合切割型外科器械对本发明的各种实施例进行了描述。然而,应该指出的是,在其它实施例中,本文公开的本发明的外科器械不必为切割型外科器械,而是可被用于包括遥感器转发器的任何类型的外科器械中。例如,其可为非切割内窥镜式器械、抓紧器、缝合器、施加器、进入装置、药物/基因治疗递送装置、利用超声波、射频、激光等的能量装置。此外,本发明例如可为腹腔镜式器械。本发明也可在传统的内窥镜式和开放式外科器械以及机器人辅助的手术中得到应用。
可将本发明所公开的装置设计为单次使用后即进行处理,或者可将它们设计为可多次使用。然而,在任一种情况下,所述装置均可进行调理以在至少一次使用后再次使用。重新调理可包括如下步骤的任意组合:拆卸该装置;然后清洗或置换某些部分;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的任意数目的特定零件或部分。清洗和/或置换特定部分后,该装置可以在调理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团队重新组装。本领域的技术人员将会知道,装置的调理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调理过的装置均在本发明的范围内。
尽管本文已经结合某些公开的实施例描述了本发明,但是可对那些实施例进行多种修改和变型。例如,可采用不同类型的端部执行器。另外,凡是公开了用于某些部件的材料的情形均可使用其它材料。上述描述和以下权利要求旨在涵盖所有这类修改形式和变型。
以引用方式全文或部分地并入本文的任何专利、公布或其它公开材料均仅在所并入的材料不与本发明所述的现有定义、陈述或其它公开材料相冲突的范围内并入本文。由此,在必要的程度下,本文所明确阐述的公开内容将取代以引用方式并入本文的任何相冲突的材料。如果据述以引用方式并入本文但与本文所述的现有定义、陈述或其它公开材料相冲突的任何材料或其部分,仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入本文。

Claims (6)

1.一种外科器械,包括:
端部执行器,所述端部执行器包括至少一个传感器;
远侧缝合单元,所述远侧缝合单元用于执行操作地连接至远程可控用户界面的至少一个外科任务;
导电轴,所述导电轴具有连接至所述端部执行器的远端,其中所述传感器与所述轴电绝缘;和
在所述轴的近端处的外壳,所述外壳能够容纳机械输入或电气输入中的至少一者;和
与所述轴电绝缘的接收器单元,所述接收器单元能够从所述传感器接收无线信号和向所述传感器发送无线信号。
2.根据权利要求1所述的外科器械,其中所述至少一个传感器包括磁阻传感器。
4.根据权利要求1所述的外科器械,其中所述至少一个传感器包括压力传感器。
5.根据权利要求1所述的外科器械,其中所述至少一个传感器包括RFID传感器。
6.根据权利要求1所述的外科器械,其中所述至少一个传感器包括MEMS传感器。
7.根据权利要求1所述的外科器械,其中所述至少一个传感器包括机电传感器。
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