CN101507621A - 电动外科切割和紧固器械 - Google Patents

电动外科切割和紧固器械 Download PDF

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CN101507621A
CN101507621A CNA2009100078132A CN200910007813A CN101507621A CN 101507621 A CN101507621 A CN 101507621A CN A2009100078132 A CNA2009100078132 A CN A2009100078132A CN 200910007813 A CN200910007813 A CN 200910007813A CN 101507621 A CN101507621 A CN 101507621A
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end effector
motor
electrode
power
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CN101507621B (zh
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D·C·耶茨
F·E·谢尔顿四世
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Ethicon Endo Surgery Inc
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Abstract

本发明涉及一种外科切割和紧固器械,具体地涉及电动外科切割和紧固器械。所述器械包括端部执行器、连接到所述端部执行器的轴、和连接到所述轴的手柄。所述手柄包括:直流电动机,该电动机连接到传动系统以给所述传动系统提供动力;多个串联的直流功率源,所述直流功率源连接到所述电动机以给所述电动机提供电力。所述手柄还包括功率源选择开关,所述功率源选择开关在第一状态时将所有的所述直流功率源连接到所述电动机,并且在第二状态时将所述直流功率源的一部分连接到所述电动机。本发明还公开了用于致动端部执行器中的射频电极的部件以及用于指示所述射频电极的致动的部件。

Description

电动外科切割和紧固器械
相关申请的交叉引用
本申请涉及以下同时提交的申请并且通过引用结合以下同时提交的申请:
Motorized Surgical Cutting and Fastening Instrument Having aMagnetic Drive Train Torque Limiting Device(代理卷号No.END6267USNP/070389);
Motorized Surgical Cutting and Fastening Instrument HavingHandle Based Power Source(代理卷号No.END6269USNP/070391);
Surgical Cutting and Fastening Instrument Having RF Electrodes(代理卷号No.END6270USNP/070392);
Motorized Cutting and Fastening Instrument Having ControlCircuit For Optimizing Battery Usage(代理卷号No.END6271USNP/070393)。
技术领域
本发明总的涉及外科切割和紧固器械,更具体地涉及电动外科切割和紧固器械。
背景技术
在现有技术中,外科钉合器已被用于同时在组织中形成纵向切口和将钉线施加在切口的相对侧上。这样的器械通常包括一对协同动作的钳口构件,如果器械预期用于内窥镜或腹腔镜应用中,钳口构件能够穿过套管通道。一个钳口构件容纳具有至少两个横向间隔开的钉排的钉仓。另一钳口构件限定了具有钉成形凹座的砧座,该钉成形凹座与钉仓中的钉排对齐。这样的器械通常包括多个往复运动的楔形件,当向远端驱动所述楔形件时,所述楔形件穿过钉仓中的开口并与支撑钉的驱动器接合,以使钉向着砧座击发。
在公开号为No.2004/0232196 A1,题为“Surgical staplinginstrument having separate distinct closing and firing systems”的美国专利申请中描述了适合内窥镜应用的外科钉合器的例子,该申请的内容通过引用结合入本文中。在使用中,临床医生能使钉合器的钳口构件闭合在组织上以在击发前对组织进行定位。如果临床医生已经确定钳口构件适当地夹住了组织,则临床医生可击发外科钉合器,由此切割和钉合组织。同时切割和钉合的步骤避免了当用仅能分别进行切割或者钉合的不同外科工具顺序地进行所述动作时可能引起的并发症。
此外,在端部执行器中包括电极是现有技术中已知的,所述端部执行器能够用于发射/接收射频(RF)能量以沿着切割线形成止血线。题为“Electrosurgical hemostatic device”的美国专利5,403,312(以下称为’312号专利)公开了具有端部执行器的电外科器械,该端部执行器将组织压缩在双极能量源的处于第一分界面上的第一极(电极)和处在第二分界面上的第二极(或电极)之间,所述专利通过引用结合入本文。RF能量被施加穿过压缩在端部执行器中的组织并且烧灼所述组织。’312号专利中的端部执行器还包括用于钉合被压缩在端部执行器中的组织的钉。
由电动机给切割器械提供动力的电动外科切割和紧固器械在现有技术中也是已知的,诸如在公开号为No.2007/0175962 A1,题为“Motor-driven surgical cutting and fastening instrument with tactileposition feedback”的美国专利申请中所述,该申请通过引用结合入本文。
发明内容
在一个总的方面中,本发明的实施方式涉及外科切割和紧固器械。所述器械可以是诸如线性内切割器或圆形切割器的内窥镜器械,或者可以是腹腔镜器械。所述器械可包括用于紧固被夹紧在端部执行器中的组织的钉和/或RF电极。
本文公开的多种实施方式涉及无绳(cordless)电动器械。该器械可通过包括直流(DC)功率源(诸如一个或多个串联的电池)的电源包供电。电池选择开关可控制在给定时刻用于给电动机供电的电池数量,以便控制电动机可获得的功率。这允许器械操作者更好地控制电动机的速度和功率。此在另一种实施方式中,器械可包括用于调节供应给电动机的电压的功率调节器,功率调节器包括例如直流-直流转换器。另外,功率调节器的电压设定值可被设置成,使得从功率源传输的电压小于在功率源传输最大功率时的电压。这样,功率源(例如多个串联的电池)在功率曲线的“左”侧或上升侧工作,从而可获得功率的增加。
另外,根据各种实施方式,功率源可包括次级蓄电装置,诸如可充电电池或超级电容器。这样的次级蓄电装置可通过可更换电池反复充电。充电管理电路可控制次级蓄电装置的充电并且提供各种状态信号,诸如当次级蓄电装置完成充电时的警报。
在其它实施方式中,包括次级蓄电装置的电源包可从器械拆下并且可连接到远离器械的充电器座上。充电器座可从交流(AC)电力网或电池对次级蓄电装置充电。充电器座还可包括处理器和存储单元。存储在可拆卸的电源包的存储器中的数据可被下载到充电器座,数据例如可由用户(例如医生)、器械制造商或经销商等从充电器座上传以供稍后使用和分析。数据可包括工作参数(诸如充电周期信息)以及器械的各种可更换部件(诸如钉仓)的标识(ID)值。
另外,器械可包括扭矩限制装置以限制由电动机提供的扭矩,由此限制可能损坏器械部件的致动力。根据各种实施方式,扭矩限制装置可以是电磁体或永磁体,或者是(直接地或间接地)连接到电动机输出极的机械离合装置。
在另一个总的方面中,本发明涉及带有新型电极构型的RF器械(即,外科切割和紧固器械,该器械在端部执行器处具有用于将RF能量施加到由端部执行器保持的组织上的电极)。一般而言,新型电极构型包括较小的有源电极和较大的返回电极的组合。较小的有源电极被用于将治疗能量集中在组织上,而较大的返回电极优选地用于以对组织界面影响极小的方式接通电路。返回电极典型地具有较大质量,由此能够在电外科应用中保持温度较低。
另外,根据各种实施方式,端部执行器可包括多个共线的分段有源电极。分段电极可同步地通电,或者更优选地顺序地通电。顺序地激活分段电极提供了以下优点:(1)由于组织凝结的目标范围较小而减少了瞬时功率需求;以及(2)如果在一个分段短路时允许其它分段进行击发。
另外,本文公开了用于激活RF电极以及用于使端部执行器进行关节运动的多种机构。
本发明具体地包括以下内容:
(1).一种外科切割和紧固器械,包括:
端部执行器;
连接到所述端部执行器的轴,所述轴包括用于给所述端部执行器提供动力的传动系统;和
连接到所述轴的手柄,所述手柄包括:
直流电动机,该电动机连接到所述传动系统以给所述传动系统提供动力;
多个串联的直流功率源,所述直流功率源连接到所述电动机以给所述电动机提供电力;和
功率源选择开关,所述功率源选择开关在第一状态时将所有的所述直流功率源连接到所述电动机,并且在第二状态时将所述直流功率源的一部分连接到所述电动机。
(2).如第(1)项所述的外科切割和紧固器械,其中,所述功率源选择开关包括机电开关。
(3).如第(1)项所述的外科切割和紧固器械,其中,所述功率源选择开关包括固态开关。
(4).如第(1)项所述的外科切割和紧固器械,其中,所述端部执行器包括圆形切割端部执行器。
(5).如第(1)项所述的外科切割和紧固器械,其中,所述端部执行器包括线性切割端部执行器。
(6).一种外科切割和紧固器械,包括:
端部执行器;
连接到所述端部执行器的轴,所述轴包括用于给所述端部执行器提供动力的传动系统;和
连接到所述轴的手柄,所述手柄包括:
直流电动机,该电动机连接到所述传动系统以给所述传动系统提供动力;
直流功率源;和
功率调节器,该功率调节器具有与所述直流功率源连接的输入和与所述电动机的输入连接的输出。
(7).如第(6)项所述的外科切割和紧固器械,其中,所述直流功率源包括至少一个电池。
(8).如第(6)项所述的外科切割和紧固器械,其中,所述直流功率源包括至少一个蓄电装置。
(9).如第(8)项所述的外科切割和紧固器械,其中,所述至少一个蓄电装置包括至少一个超级电容器。
(10).如第(6)项所述的外科切割和紧固器械,其中,所述功率调节器包括直流-直流功率转换器。
(11).如第(10)项所述的外科切割和紧固器械,其中,所述直流-直流功率转换器包括开关模式功率转换器。
(12).如第(10)项所述的外科切割和紧固器械,其中,所述直流-直流功率转换器包括升降压式转换器。
(13).一种外科切割和紧固器械,包括:
端部执行器;
连接到所述端部执行器的轴,所述轴包括用于给所述端部执行器提供动力的传动系统;和
连接到所述轴的手柄;
直流电动机,该电动机连接到所述传动系统以给所述传动系统提供动力;
可充电的直流功率源,该直流功率源连接到所述电动机以给所述电动机提供电力;和
用于显示直流功率源的充电状态的部件。
(14).如第(13)项所述的外科切割和紧固器械,其中,用于显示直流功率源的充电状态的部件包括至少一个发光二极管。
(15).如第(13)项所述的外科切割和紧固器械,其中,所述端部执行器包括至少一个射频电极,并且还包括用于指示所述至少一个射频电极的致动的部件。
(16).如第(15)项所述的外科切割和紧固器械,其中,用于指示所述至少一个射频电极的致动的部件包括显示装置。
(17).如第(15)项所述的外科切割和紧固器械,其中,用于指示所述至少一个射频电极的致动的部件包括扬声器。
(18).如第(15)项所述的外科切割和紧固器械,其中,用于指示所述至少一个射频电极的致动的部件包括振动器。
(19).如第(15)项所述的外科切割和紧固器械,其中,用于指示所述至少一个射频电极的致动的部件包括光源。
(20).一种外科紧固器械,包括:
端部执行器,包括:
相对的上钳口和下钳口;
至少一个射频电极,所述射频电极要么连接到所述上钳口要么连接到所述下钳口;
连接到所述至少一个射频电极的射频功率源;
连接到所述端部执行器的轴;
连接到所述轴的手柄,其中,所述手柄包括:
能以枢转方式缩回的闭合扳机,所述闭合扳机在以枢转方式朝着所述手柄缩回时引起相对的所述上钳口和所述下钳口夹紧;和
用于致动所述至少一个电极的部件。
(21).如第(20)项所述的外科紧固器械,其中,用于致动所述至少一个电极的部件包括麦克风。
(22).如第(20)项所述的外科紧固器械,其中,用于致动所述至少一个电极的部件包括收发器。
(23).如第(20)项所述的外科紧固器械,其中,用于致动所述至少一个电极的部件包括拨盘式控制器。
(24).如第(20)项所述的外科紧固器械,还包括用于指示所述至少一个射频电极的致动的部件。
附图说明
下面结合附图通过例子来描述本发明的各种实施方式,其中:
图1和2是根据本发明的各种实施方式的外科切割和紧固器械的透视图;
图3到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是在根据本发明的各种实施方式的器械中使用的电路的示意图;
图12-14和17是用于给根据本发明的各种实施方式的器械的电动机供电的电路的示意图;
图15是示出了根据本发明的各种实施方式的充电管理电路的框图;
图16是示出了根据本发明的各种实施方式的充电器座的框图;
图18示出了电池的典型功率曲线;
图19-22示出了根据本发明的各种实施方式的离合器式电磁扭矩限制装置的实施方式;
图23-25,27-28和59是根据本发明的各种实施方式的器械的砧座的底面的视图;
图26,53,54和68是根据本发明的各种实施方式的端部执行器的正剖视图;
图29-32示出了根据本发明的各种实施方式的具有RF电极的端部执行器的一种实施方式;
图33-36示出了根据本发明的各种实施方式的具有RF电极的端部执行器的另一种实施方式;
图37-40示出了根据本发明的各种实施方式的具有RF电极的端部执行器的另一种实施方式;
图41-44示出了根据本发明的各种实施方式的具有RF电极的端部执行器的另一种实施方式;
图45-48示出了根据本发明的各种实施方式的具有RF电极的端部执行器的另一种实施方式;
图49-52示出了根据本发明的各种实施方式的具有RF电极的端部执行器的另一种实施方式;
图55和图56示出了根据本发明的各种实施方式的端部执行器的侧视图;
图57是根据本发明的另一种实施方式的器械的手柄的简图;
图58是根据本发明的各种实施方式的图57中的实施方式的手柄的剖视图;
图60-66示出了根据本发明的各种实施方式的多层电路板;
图67是示出了根据本发明的各种实施方式的端部执行器的简图;
图69和图70是根据本发明的各种实施方式的包括柔性颈部组件的器械的简图。
具体实施方式
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。所示实施方式是内窥镜器械,一般来说,本文中描述的器械10的实施方式是内窥镜外科切割和紧固器械。然而应当注意的是,根据本发明的其他实施方式,所述器械可以是非内窥镜外科切割和紧固器械,例如是腹腔镜器械。
图1与2中所示的外科器械10包括手柄6、轴8和在关节运动枢轴14处与轴8枢转连接的关节运动端部执行器12。关节运动控制器16可靠近手柄6设置,以使端部执行器12围绕关节运动枢轴14旋转。在所示的实施方式中,端部执行器12构造为作为用于夹紧、切割及钉合组织的内切割器,尽管如此,在其它实施方式中,也可采用不同类型的端部执行器,例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、钉合器、夹子施放器、进入装置、药物/基因治疗装置、超声波、RF或激光装置等。与RF装置有关的细节参见’312号专利。
器械10的手柄6可包括用于致动端部执行器12的闭合扳机18和击发扳机20。应理解,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目或类型的扳机或者其它用于操作端部执行器12的合适控制器。示出的端部执行器12通过优选的细长轴8与手柄6分离。在一种实施方式中,器械10的临床医生或者操作人员可利用关节运动控制器16使端部执行器12相对于轴8进行关节运动,如在由Geoffrey C.Hueil等人的公开号为No.2007/0158385 A1、题为“Surgical Instrument Having An Articulating End Effector”的美国专利申请中更详细描述,其内容通过引用包含于本申请中。
在该例子中,端部执行器12除了包括其它零部件外还包括钉通道22和可枢转平移的夹紧构件,例如砧座24,钉通道和夹紧构件以一间距被保持,该间距确保对夹紧在端部执行器12中的组织进行有效钉合及切割。手柄6包括手枪式握把26,由医生向着手枪式握把26可枢转地拉动闭合扳机18可使砧座24向着端部执行器12的钉通道22夹紧或者闭合,从而夹紧定位在砧座24和通道22之间的组织。击发扳机20位于比闭合扳机18更远的外侧。一旦闭合扳机18被锁定在闭合位置(将在下面进一步描述),击发扳机20可略微向着手枪式握把26旋转,使其可被操作人员使用一只手触及。然后操作人员可向着手枪式握把26枢转地拉动击发扳机20,引起夹紧在端部执行器12中的组织的钉合及切割。在其它实施方式中,可使用除了砧座24以外的不同类型的夹紧构件,例如相对的钳口等。
应当理解,在本文中使用的术语“近侧”和“远侧”以握持器械10的手柄6的医生为参考。因此,相对于更近的手柄6而言,端部执行器12处于远侧。还应理解,为了方便和清楚起见,在本文中使用的空间术语,诸如“垂直”和“水平”是相对于附图而言。但是,所述外科器械以许多方向和位置被使用,这些术语并不是限定性的和绝对的。
闭合扳机18可首先被致动。一旦医生对端部执行器12的位置感到满意,医生可将闭合扳机18向着靠近手枪式握把26的其完全闭合锁定位置拉回。然后可致动击发扳机20。当医生去掉压力时(将在下面更全面描述),击发扳机20返回打开位置(在图1和2中显示)。手柄6上的释放按钮在压下时可释放锁定的闭合扳机18。释放按钮可以各种形式实现,例如诸如在图7中显示的滑动释放按钮160,或在公布的美国专利申请No.2007/01755955 A1中描述的任何机构,该专利申请通过引用结合入本文。
图3是根据各实施方式的端部执行器12的分解图。如在示出的实施方式中所示,除了前面提到的通道22和砧座24以外,端部执行器12可包括切割器械32、滑橇33、可拆卸地安装在通道22中的钉仓34和螺纹轴36。切割器械32例如可以是刀。砧座24可在与通道22的近端连接的枢轴点25处可枢转地打开和闭合。砧座24还可包括位于其近端的翼片27,其可插入到机械闭合系统的部件中(在下面进一步描述)以打开和闭合砧座24。当闭合扳机18被致动时,也就是说由器械10的用户拉动时,砧座24可围绕枢轴点25枢转进入夹紧或者闭合位置。如果端部执行器12的夹紧是满意的,操作人员可致动击发扳机20,如同将在下面更详细描述的那样,这引起刀32和滑橇33沿着通道22纵向行进,从而切割夹紧在端部执行器12中的组织。滑橇33沿着通道22的运动引起钉仓34的钉被驱动穿过被切割的组织并抵靠闭合的砧座24,所述砧座使钉弯曲以紧固被切割的组织。在各实施方式中,滑橇33可以是钉仓34的一体部件。题为“Surgical stapling instrument incorporating an E-beam firingmechanism”的美国专利6,978,921提供了关于所述两冲程切割和紧固器械的更多细节,其内容通过引用而包含在本申请中。滑橇33可以是钉仓34的一部分,使得当刀32在切割操作之后回缩时,滑橇33不回缩。
应注意的是,尽管这里描述的器械10的实施方式采用对切割的组织进行钉合的端部执行器12,在其它实施方式中也可使用用于紧固或者密封被切割组织的不同技术。例如,也可使用采用RF能量或者粘合剂来紧固被切割组织的端部执行器。Yates等人的题为“ELECTROSURGICAL HEMOSTATIC DEVICE”的美国专利5,709,680,和Yates等人的题为“ELECTROSURGICALHEMOSTATIC DEVICE WITH RECESSED AND/OR OFFSETELECTRODES”的美国专利5,688,270公开了使用RF能量来密封被切割组织的内窥镜切割器械,它们的内容都通过引用包含在本申请中。同样通过引用而包含在本申请中的Jerome R.Morgan等人的公开号为No.2007/0102453A1的美国专利申请和Frederick E.Shelton,IV等人的公开号为No.2007/0102452 A1的美国专利申请公开了使用粘合剂来紧固被切割组织的内窥镜切割器械。因此,尽管本文中此处以及下面类似的描述指的是切割/钉合操作,应当认识到,这是典型实施方式而不意味着限制。也可采用其它组织紧固技术。
图4和5是根据各实施方式的端部执行器12和轴8的分解图,图6是根据各实施方式的端部执行器12和轴8的侧视图。如在所示的实施方式中所示,轴8可包括由枢转连接件44可枢转连接的近侧闭合管40和远侧闭合管42。远侧闭合管42包括开口45,砧座24上的翼片27插入开口45中以便打开和闭合砧座24(将在下面进一步描述)。近侧脊管46设置在闭合管40、42内部。设置在近侧脊管46内部的是主旋转(或者近侧)传动轴48,其借助锥齿轮组件52与次级(或远侧)传动轴50相连。次级传动轴50与传动齿轮54连接,所述传动齿轮54与螺纹轴36的近侧传动齿轮56接合。垂直锥齿轮52b可安放在近侧脊管46的远端中的开口57中并在其中枢转。远侧脊管58可用于包围次级传动轴50和传动齿轮54、56。共同地,主传动轴48、次级传动轴50和关节运动组件(例如锥齿轮组件52a-c)有时在本文中称为“主传动轴组件”。
定位在钉通道22的远端的轴承38容纳螺旋传动螺杆36,允许螺旋传动螺杆36相对于通道22自由旋转。螺旋传动螺杆轴36可连接刀32的带螺纹的开口(未显示),使轴36的旋转引起刀32经过钉通道22向远侧或者近侧(取决于旋转方向)平移。因此,当主传动轴48被击发扳机20致动引起旋转(将在下面更详细解释)时,锥齿轮组件52a-c引起次级传动轴50旋转,进而由于传动齿轮54、56的接合引起螺纹轴36旋转,这引起刀驱动构件32沿着通道22纵向行进以切割夹紧在端部执行器中的任何组织。滑橇33例如可由塑料制成,并可具有倾斜的远侧表面。当滑橇33穿过通道22时,向前倾斜的表面可向上推动或者驱动钉仓中的钉穿过夹紧的组织并抵靠砧座24。砧座24使钉弯曲,从而钉合切割的组织。当刀32回缩时,刀32和滑橇33可脱离接合,从而将滑橇22留在通道22的远端。
图7-10示出了电动内切割器的示例性实施方式。示出的实施方式提供了有关端部执行器中切割器械的使用和加载力的用户反馈。另外,该实施方式可在回缩击发扳机20时使用由用户提供的动力给装置提供动力(所谓的“动力辅助”模式)。如在所示的实施方式中所示,手柄6可包括外部下侧件59、60和外部上侧件61、62,它们配合在一起总体形成手柄6的外部形状。电池64,例如锂离子电池可设置在手柄6的手枪式握把26部分中。电池64为设置在手柄6的手枪式握把26部分的上部中的电动机65供电。根据各实施方式,串联的多个电池可被用于给电动机65供电。
电动机65可以是在空载时具有大约25000转每分钟的最大转速的DC有刷驱动电动机。电动机65可驱动90°锥齿轮组件66,其包括第一锥齿轮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可包括与传动轴76连接的小齿轮74。小齿轮74可驱动配合的环形齿轮78,所述环形齿轮78经传动轴82驱动螺旋齿轮鼓80。环84可与螺旋齿轮鼓80螺纹接合。因此,当电动机65旋转时,通过介于其间的锥齿轮组件66、行星齿轮组件72和环形齿轮78使环84沿着螺旋齿轮鼓80行进。
手柄6还可包括与击发扳机20通信的运转电动机传感器110,以便检测何时击发扳机20已经由操作人员向着手柄6的手枪式握把部分26拉近(或者“闭合”),从而致动端部执行器12的切割/钉合操作。所述传感器110可以是比例传感器,例如诸如变阻器或者可变电阻器。当击发扳机20被拉近时,传感器110检测运动并发送指示供给到电动机65的电压(或者功率)的电信号。当传感器110是可变电阻器或其类似物时,电动机65的旋转通常可与击发扳机20的运动量成比例。也就是说,如果操作人员仅仅以很小的力拉动或者闭合击发扳机20,电动机65的旋转相对较慢。当击发扳机20被完全拉近(或者处于完全闭合位置)时,电动机65以其最大速度旋转。换言之,用户拉动击发扳机20越困难,施加到电动机65上的电压越高,引起更大的旋转速度。
手柄6可包括靠近击发扳机20上部的中间手柄件104。手柄6还包括连接在中间手柄件104和击发扳机20的支柱之间的偏压弹簧112。偏压弹簧112可将击发扳机20偏压到其完全打开位置。在该方式中,当操作人员释放击发扳机20时,偏压弹簧112将击发扳机20向着其打开位置拉动,由此除去传感器110的致动,从而使电动机65停止旋转。而且,借助于偏压弹簧112,在用户闭合击发扳机20的任何时候,用户将受到对于闭合操作的阻力,从而为用户提供有关由电动机65施加的旋转量的反馈。此外,电动机可停止回缩击发扳机20,从而除去来自传感器200的力,由此停止电动机65。这样,用户可停止端部执行器12的使用,从而为操作人员提供切割/紧固操作的控制手段。
螺旋齿轮鼓80的远端包括驱动与小齿轮124配合的环形齿轮122的远侧传动轴120。小齿轮124与主传动轴组件的主传动轴48连接。这样,电动机65的旋转引起主传动轴组件旋转,这引起端部执行器12的致动,如上所述。
螺纹接合在螺旋齿轮鼓80上的环84可包括设置在带槽的臂90的槽88中的支柱86。带槽的臂90在其相对的一端94上具有开口92,该相对的一端94容纳连接在手柄外侧件59、60之间的枢轴销96。枢轴销96还经过开口100设置在击发扳机20中并经过开口102设置在中间手柄件104中。
另外,手柄6可包括反向电动机传感器(或者冲程结束传感器)130和停止电动机(或者冲程开始)传感器142。在各实施方式中,反向电动机传感器130可以是设置在螺旋齿轮鼓80的远端的限位开关,当环84到达螺旋齿轮鼓80的远端时,使螺纹连接在螺旋齿轮鼓80上的环84与反向电动机传感器130接触并使之启动。当被激活时,反向电动机传感器130发送信号到电动机65,使其反向旋转,从而在切割操作之后缩回端部执行器12的刀32。停止电动机传感器142例如可以是常闭的限位开关。在各实施方式中,其可以设置在螺旋齿轮鼓80的近端,当环84到达螺旋齿轮鼓80的近端时,由环84断开所述开关142。
在操作中,当器械10的操作人员向后拉动击发扳机20时,传感器110检测击发扳机20的使用并发送信号到电动机65,引起电动机65以例如与操作人员向后拉动击发扳机20的困难程度成比例的速度向前旋转。电动机65向前旋转进而引起行星齿轮组件72远端的环行齿轮78旋转,从而引起螺旋齿轮鼓80旋转,引起以螺纹方式接合在螺旋齿轮鼓80上的环84沿着螺旋齿轮鼓80向远侧行进。螺旋齿轮鼓80的旋转还驱动上述主传动轴组件,所述主驱动器轴组件进而引起刀32在端部执行器12中使用。也就是说,引起刀32和滑橇33纵向穿过通道22,从而切割端部执行器12中夹紧的组织。而且,在使用钉合型端部执行器的实施方式中,引起端部执行器12的钉合操作发生。
在端部执行器12的切割/钉合操作完成的时刻,螺旋齿轮鼓80上的环84将到达螺旋齿轮鼓80的远端,从而使反向电动机传感器130启动,发送信号到电动机65引起电动机65反转其旋转方向。这又使刀32回缩,并引起螺旋齿轮鼓80上的环84向后运动到螺旋齿轮鼓80的近端。
中间手柄件104包括与带槽的臂90接合的后侧肩106,如在图8和9中最好地显示的。中间手柄件104还具有与击发扳机20接合的向前运动止动件107。带槽的臂90的运动受到电动机65的旋转的控制,如上所述。在随着环84从螺旋齿轮鼓80的近端向远端行进,带槽的臂90逆时针旋转时,中间手柄件104将自由地逆时针旋转。因此,当用户拉近击发扳机20时,击发扳机20将接合中间手柄件104的向前运动止动件107,引起中间手柄件104逆时针旋转。但是,由于后侧肩106接合带槽的臂90,中间手柄件104将仅仅能够逆时针旋转直到带槽的壁所允许的程度。这样,如果电动机65由于某个原因停止旋转,带槽的臂90将停止旋转,用户将不能进一步拉近击发扳机20,因为由于带槽的臂90使中间手柄件104不能自由逆时针旋转。
在图7-10中显示了用于通过回缩闭合扳机18来闭合(或夹紧)端部执行器12的砧座24的示例性闭合系统的元件。在所示的实施方式中,闭合系统包括通过销251与闭合扳机18连接的轭形件250,所述销251经过闭合扳机18和轭形件250两者中对准的开口插入。枢轴销252经过闭合扳机18中的与销251插入穿过闭合扳机18的地方错位的另一个开口插入,闭合扳机18围绕所述枢轴销252枢转。因此,闭合扳机18的回缩引起闭合扳机18的上部逆时针旋转,轭形件250经销251与所述闭合扳机的上部连接。轭形件250的远端通过销254连接到第一闭合支架256。第一闭合支架256连接到第二闭合支架258。共同地,闭合支架256、258限定一个开口,近侧闭合管40(见图4)的近端安放并保持在所述开口中,从而使闭合支架256、258的纵向运动引起近侧闭合管40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可包括窗口261,位于一个手柄外部件(例如在所示的实施方式中的外部下侧件59)上的支柱263设置在该窗口261中,将闭合杆260固定连接到手柄6。以该方式,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,其配合在近侧脊管46中的空腔269中并由帽271限制在其中(见图4)。
在操作过程中,当轭形件250由于闭合扳机18的回缩而旋转时,闭合支架256、258引起近侧闭合管40向远端运动(即远离器械10的手柄端),引起远侧闭合管42向远端运动,引起砧座24围绕枢轴点25旋转到夹紧或者闭合位置中。当闭合扳机18没有锁定在锁定位置中时,引起近侧闭合管40向近端滑动,引起远侧闭合管42向近端滑动,借助被插入到远侧闭合管42中的翼片27引起砧座24围绕枢轴点25旋转到打开或者未夹紧位置中。以该方式,通过回缩并锁定闭合扳机18,操作人员可将组织夹紧在砧座24和通道22之间,并可在切割、夹紧操作之后通过打开闭合扳机20从锁定位置释放夹紧的组织。
图11是根据本发明的各实施方式的器械10的电路的示意图。在锁定闭合扳机18之后当操作人员开始拉近击发扳机20时,激活传感器110,允许电流流过。如果常开的反向电动机传感器开关130断开(意味着端部执行器冲程的末端还没有到达),电流将流到单刀双掷继电器132。由于反向电动机传感器开关130没有闭合,继电器132的电感器134将不被通电,使继电器132处于其非通电状态。所述电路还包括钉仓锁定传感器136。如果端部执行器12包括钉仓34,传感器136将处于闭合状态,允许电流流动。相反,如果端部执行器12不包括钉仓34,传感器136将断开,从而防止电池64为电动机65供电。
当钉仓34存在时,传感器136闭合,这会给单刀单掷继电器138通电。当继电器138被通电时,电流流过继电器136和可变电阻型传感器110并经由双刀双掷继电器140流到电动机65,从而为电动机65供电,允许其沿着向前的方向旋转。当端部执行器12到达其冲程末端时,反向电动机传感器130将被激活,从而闭合开关130并为继电器134通电。这引起继电器134采取其通电状态(在图13中未显示),引起电流绕过钉仓锁定传感器136和可变电阻器110,不是引起电流流到常闭的双刀双掷继电器142并返回到电动机65,而是经过继电器140使电动机65反转。由于停止电动机传感器开关142是常闭的,电流将回流到继电器134以保持其闭合,直到开关142断开。当刀32完全回缩时,停止电动机传感器开关142被激活,引起开关142断开,从而使电动机65断电。
在其它实施方式中,与比例型传感器110不同,可使用通断型传感器。在所述实施方式中,电动机65的旋转速度将不再与操作人员施加的力成比例。而是,电动机65一般将以稳定速度旋转。但是因为击发扳机20与齿轮传动系统接合,操作人员仍将感受到反馈的力。
在公开号为No.2007/0175962 A1,题为“Motor-driven surgicalcutting and fastening instrument with tactile position feedback”的美国专利申请中公开了电动外科器械的另外构型,该美国专利申请通过引用结合入本文。
在电动外科器械(诸如上述电动内窥镜器械的一种)中,或在电动圆形切割器器械中,电动机可通过串联的多个电池供电。另外,在某些场合可能需要利用所有电池的一部分给电动机供电。例如,如图12所示,电动机65可通过电源包299供电,该电源包299包括串联的六(6)个电池310。电池310可例如是3伏锂电池,诸如CR123A电池,但是在其它实施方式中,可以使用不同类型的电池(包括带有不同电压水平和/或不同化学性质的电池)。如果六个3伏电池310被串联以给电动机65供电,则可供电动机65使用的总电压为18伏。电池310可包括可充电电池或不可充电电池。
在这样的实施方式中,电动机65的输入电压在最大负载情况下可降到大约九至十伏。在该工作条件下,电源包299将最大功率传输至电动机65。因此,如图12所示,电路可包括开关312,所述开关312选择性地允许通过(1)所有电池310或(2)一部分电池310来给电动机65供电。如图12所示,通过适当选择,开关312可允许通过所有六个电池或四个电池给电动机65供电。这样,开关312可被用于以18伏(当使用所有六个电池310时)或12伏(当使用其中的四个电池时)给电动机65供电。在各种实施方式中,用于给电动机65供电的这部分电池的电池数量的设计选择可基于电动机65在以用于最高负载的最大输出工作时所需的电压。
开关312可例如是机电开关,诸如微开关。在其他实施方式中,开关312可实施为固态开关,诸如晶体管。第二开关314(诸如按钮开关)可被用于控制功率到底是否被施加到电动机65上。同样,正向/反向开关316可被用于控制电动机65是否沿着正向或反向旋转。正向/反向开关316可被实施为双刀-双掷开关,诸如如图11所示的继电器140。
在工作中,器械10的用户可通过使用某类开关控制器来选择期望的功率水平,开关控制器例如未显示的取决于位置(position-dependent)的开关,诸如拨动开关、机械杠杆开关或凸轮,该开关控制器控制开关312的位置。用户随后可激活第二开关314以将选择的电池310连接到电动机65。另外,如图12所示的电路可被用于给其他类型的电动外科器械(诸如圆形切割器和/或腹腔镜器械)的电动机供电。关于圆形切割器的更多细节可在公开号为No.2006/0047307 A1和公开号为No.2007/0262116 A1的美国专利申请中找到,所述专利申请通过引用结合入本文。
如图13所示,在其他实施方式中,诸如电池(例如CR2或CR123A电池)的初级功率源340可被用于对多个次级蓄电装置342充电。初级功率源340可包括一个或多个串联的电池,优选地,所述电池在示出的实施方式中是可更换的。次级蓄电装置342可包括例如可充电电池和/或超级电容器(也称为“超电容器”或“电化学双层电容器”(EDLC))。与普通电解电容器相比,超级电容器是具有非常高的能量密度的电化学电容器,通常比高容量电解电容器高数千倍。
初级功率源340可对次级蓄电装置342充电。如果次级蓄电装置342被充足电,则初级功率源340可被拆下并且次级蓄电装置342可用于在手术或工作期间给电动机65供电。在各种情况下,次级蓄电装置342可能需要大约十五至三十分钟的充电时间。超级电容具有以下特性:与常规电池相比,超级电容器可被极其快速地充电和放电。另外,电池仅对有限次数的充电/放电循环有效,但是超级电容器通常可被重复充电/放电,有时候能达到成千上万次的充电/放电周期。对于使用超级电容器作为次级蓄电装置342的实施方式而言,超级电容器可包括碳纳米管、传导聚合物(例如聚乙烯)或碳气凝胶。
如图14所示,可采用充电管理电路344来确定次级蓄电装置342何时被充足电。充电管理电路344可包括指示器,诸如一个或多个发光二极管(LED)、液晶显示器(LCD)等,当次级蓄电装置342被充足电时,指示器被激活以给器械10的用户警报。
初级功率源340、次级蓄电装置342和充电管理电路344可以是在器械10的手柄6的手枪式握把部分26中或者在器械10的另一部分中的电源包的一部分。电源包可从手枪式握把部分26拆除,在这种情况下,当器械10即将被用于外科手术时,电源包可由例如协助手术的轮值护士以无菌的方式插入手枪式握把部分26(或根据其他实施方式的器械中的其他位置)中。在插入电源包后,护士可以在使用器械10之前将可更换的初级功率源340放入电源包中以对次级蓄电装置342充电一段时间,例如三十分钟。当次级蓄电装置342充好电时,充电管理电路344可指示所述电源包已准备就绪。此时,可更换的初级功率源340可被取出。在工作期间,器械10的用户随后可诸如通过激活开关314来激活电动机65,由此使次级蓄电装置342给电动机65供电。因此,作为使用多个一次性电池给电动机65供电的替代,在这种实施方式中可使用一个一次性电池(作为初级功率源340),并且次级蓄电装置342是可重复使用的。但是,在替代实施方式中,应当注意到,次级蓄电装置342可以是可充电的和/或不可重复使用的。次级蓄电装置342可与以上结合图12描述的电池选择开关312一起使用。
充电管理电路344还可包括指示器(例如LED或LCD显示器),该指示器指示次级蓄电装置342剩余多少电量。这样,外科医生(或器械10的其他使用者)可看到在涉及器械10的手术的整个过程中有多少电量剩余。
如图15所示,充电管理电路344可包括电量计345(chargemeter),用于测量次级蓄电装置342的电量。充电管理电路344还可包括非易失性存储器346(诸如闪存或只读存储器)和一个或多个处理器348。一个或多个处理器348可连接到存储器346以控制所述存储器。另外,处理器348可被连接到电量计345以读取电量计345的读数或者控制电量计345。另外,处理器348可控制充电管理电路344的LED或其他输出装置。处理器348可将器械10的参数存储在存储器346中。所述参数可包括器械的工作参数,所述工作参数通过可在器械10中安装或采用的各种传感器来感测,所述工作参数例如是击发次数、有关力的大小,端部执行器12的相对钳口之间的压缩间隙(compression gap)的距离、关节运动量等。此外,存储在存储器346中的参数可包括可被充电管理电路344读取和存储的器械10各部件的ID值。具有这种ID的部件可以是可更换的部件,诸如钉仓34。ID可例如是充电管理电路344通过射频标识(RFID)转发器350读取的RFID。RFID转发器350可从器械部件(诸如钉仓34)读取RFID,RFID包括RFID标签。ID值可被读取和存储在存储器346中,以及被处理器348拿来与存储在存储器346中或存储在与充电管理电路相连的存储装置中的可接受的ID值列表进行比较,以确定例如与读取的ID值相关的可拆卸/可更换的部件是否经授权和/或适当。根据各种实施方式,如果处理器348确定与读取的ID值相关的可拆卸/可更换的部件未经授权,则充电管理电路344可阻止器械10使用电源包,例如通过断开开关(未示出),从而防止功率从电源包传输到电动机65。根据各种实施方式,可被处理器348用来评估以确定部件是否经授权和/或适当的各种参数包括:日期代码;部件型号/类型;制造商;地域信息;以及早前的错误代码。
充电管理电路344还可包括用于与其他装置通信的输入/输出(i/o)接口352,如下所述。这样,存储在存储器346中的参数可被下载到另一装置。输入/输出接口352可以是例如有线接口或无线接口。
如以前所述,电源包可包括次级蓄电装置342、充电管理电路344和/或正向/反向(f/r)开关316。根据各种实施方式,如图16所示,电源包299可被连接到充电器座362上,充电器座362此外可对电源包中的次级蓄电装置342充电。通过在电源包被安装在器械10中的时候,在无菌条件下将充电器座362连接到电源包299,可将充电器座362连接到电源包299。在拆掉了电源包的其他实施方式中,通过将电源包299从器械10拆下并且将其连接到充电器座362上,可将充电器座362连接到电源包299。对于这样的实施方式,在充电器座362对次级蓄电装置342充足电后,电源包299可在无菌条件下安装在器械10中。
如图16所示,充电器座362可包括用于对次级蓄电装置342充电的功率源364。充电器座362的功率源364可以是例如电池(多个串联的电池);或者是交流(AC)/直流(DC)转换器,AC/DC转换器将诸如来自电网的交流电转换成直流电;或者是用于对次级蓄电装置342进行充电的其他适当的功率源。充电器座362还可包括指示器装置,诸如LED、LCD显示器等,用以显示次级蓄电装置342的充电状态。
另外,如图16所示,充电器座362可包括一个或多个处理器366;一个或多个存储器368;以及输入/输出接口370,372。充电器座362可通过第一输入/输出接口370与电源包299(通过电源包的输入/输出接口352)通信。这样,例如存储在电源包299的存储器346中的数据可被下载到充电器座362的存储器368。从而,处理器366可评估从充电管理电路344下载的可拆卸/可更换部件的ID值,以确定部件是否经授权以及是否合适。从充电管理电路344下载的工作参数还可被存储在存储器368中,然后可经由第二输入/输出接口372下载到另一计算机装置以供诸如医院系统(在该医院系统中执行使用器械10的手术)、外科室、器械经销商、器械制造商等进行评估和分析。
充电器座362还可包括电量计374,用于测量次级蓄电装置342的电量。电量计374可与处理器366通信,使得处理器366可实时地确定电源包299的适合性,以便用于确保高性能。
如图17所示,在另一种实施方式中,电池电路可包括功率调节器320以便控制由节电器310提供给电动机65的功率。功率调节器320还可以是电源包299的一部分,或者可以是单独部件。如上所述,电动机65可以是直流(DC)有刷电动机。DC有刷电动机的速度一般与施加的输入电压成比例。功率调节器320可给电动机65提供高稳定输出电压,使得电动机65以恒定(或基本恒定)的速度工作。根据各种实施方式,功率调节器320可包括开关模式功率转换器,诸如升降压式(buck-boost)转换器,如图17的例子所示。这样的升降压式转换器320可包括功率开关322(诸如场效应晶体管(FET))、整流器32、电感器326和电容器328。当功率开关322处于接通(on)状态时,输入电压源(例如功率源310)被直接连接到电感器326,电感器326在该状态下存储能量。在该状态下,电容器328给输出负载(例如电动机65)提供能量。当功率开关320处于断开(off)状态时,电感器326被连接到输出负载(例如电动机65)和电容器328,从而将能量从电感器326传递到电容器328和负载65。控制电路330可控制功率开关322。控制电路330可采用数字和/或模拟控制回路。此外,在其它实施方式中,控制电路330可经由通信链路(诸如串联或并联数字数据总线)接收来自主控制器(未示出)的控制信息。功率调节器320输出的电压设定值可例如被设置为开路电压的一半,在开路电压值时可从源获得最大功率。
在其它实施方式中,可采用不同功率转换器布局,包括线性或开关模式功率转换器。其它可用的开关模式布局包括反驰式、顺向式、降压式、升压式和单端初级电感式(SEPIC)。功率调节器320的电压设定值可随着用于给电动机65供电的电池数量而变化。另外,功率调节器320可用于如图13所示的次级蓄电装置342。而且,正向/反向开关316可被结合入功率调节器320中,但是在图17中正向/反向开关316是单独显示的。
电池通常可被模型化为理想电压源和电源电阻。对于理想模型,当电源电阻和负载电阻相匹配时,最大功率被传递到负载。图18示出了电池的典型功率曲线。当电池电路断开时,电池的电压高(处于其开路值)并且从电池得到的电流为零。从电池传递出的功率同样为零。随着从电池得到更多电流,电池的电压下降。由电池传递的功率是电流和电压的乘积。大约在低于开路电压的电压水平处,功率达到其峰值。如图18所示,就绝大多数电池的化学性质而言,在较高电流下,电压/功率由于化学性质或正温度系数(PTC)而急剧下降,或者由于电池保护装置而急剧下降。
尤其是对于在手术中使用电池(或复数个电池)给电动机65供电的实施方式中,控制电路330可监控输出电压并控制功率调节器320的设定值,使得电池在功率曲线的“左”侧或功率递增侧工作。如果电池达到峰值功率水平,则控制电路330可改变(例如降低)功率调节器的设定值,使得正需要从电池获得的总功率降低。电动机65随后减速。这样,从电源包获得的需量即使有,也很少超过可用的功率峰值,从而避免了手术期间的功率缺乏状况。
另外,根据其它实施方式,从电池得到的功率可被优化,使得电池内的化学反应能有时间恢复,由此优化了可从电池获得的电流和功率。在脉冲负载下,电池通常在脉冲开始时比在接近脉冲结束时提供了较大功率。这是由若干因素造成的,包括:(1)正温度系数(PTC)热敏电阻在脉冲期间可不断改变其电阻;(2)电池温度可以不断变化;和(3)电化学反应速率由于在阴极处的电解质正被消耗而不断变化,并且新电解质的扩散速率限制了反应速率。根据各种实施方式,控制电路330可控制转换器320,使得从电池获得较低电流,从而允许电池在再次受到脉冲之前恢复。
根据其它实施方式,器械10可包括离合器式扭矩限制装置。离合器式扭矩限制装置可被例如设置在电动机65和锥齿轮68之间,在锥齿轮70和行星齿轮组件72之间,或者在行星齿轮组件72的输出轴上。根据各种实施方式,扭矩限制装置可使用电磁离合器或用磁体离合器。
图19至22示出了电磁离合器400的例子,该电磁离合器400可用于根据各种实施方式的器械10。离合器400可包括马蹄形定子402,在定子402的每侧具有磁盘404、406。第一磁盘404可连接到可轴向运动且可旋转的极部408(诸如电动机65的输出极)。第二磁盘406可连接到轴向固定且可旋转的极部410(诸如器械10的齿轮箱的输入极)。在图19和20的视图中,第一极部408从第二极部410轴向地拉开间隙412,使得磁盘404、406不接合。可围绕定子400缠绕的线圈(未示出)可用于产生致动所述离合器400所需的电磁通量。当线圈传导电流时,引起的磁通量可导致两个磁盘404、406相互吸引,使得第一极部408沿着轴向朝第二极部410运动,从而使两个磁盘404、406变为接合(如图21和22所示),使得两个极部408、410将一起旋转,直到扭矩超过在磁盘404和406的表面之间产生的摩擦扭矩为止。
通过控制磁盘404、406的直径、磁盘404和406的接触面之间的摩擦系数以及通过使用在已知且可控的磁通密度下饱和的磁性材料作为磁盘404、406的材料,两个磁盘404、406之间的吸引力以及离合器400的相应扭矩容量可被控制。因此,即使在更多电流通过线圈的工作条件下,磁盘404、406的电磁材料也不会产生更大的吸引力以及相应的限制扭矩。
使用这样的离合器具有许多潜在的额外好处。在受到电控制时,可通过去除来自电线的电流使离合器400被快速释放,以限制在离合器400和电动机65内产生的热量。通过借助离合器400解除电动机与传动系统的其余部分的连接,存储在传动系统中的大多数惯性能量可被断开,从而限制了在输出突然被阻断时的冲击。另外,通过电控制,可在内部设计一些有限的滑动,有助于减少在负载条件下起动传动系统时的冲击。另外,因此离合器内的一个或多个部件(例如磁盘404、406)的磁饱和特性可被用于控制扭矩极限,而不是用于控制线圈电流,离合器400可对系统电压的变化较不敏感。在这样的实施方式中,扭矩极限主要取决于离合器部件(例如磁盘404、406)的物理尺寸,并且不需要电压调节器或其它外部部件就能正常工作。
在另一种实施方式中,扭矩限制装置可包括永磁体(未示出),而不是使用电磁离合器。永磁体可被连接到例如可轴向运动的第一极部408上并且可吸引轴向固定的第二极部410,反之亦然。在这样的实施方式中,磁盘404、406的一个可由永磁体制成,另一个可由磁性材料(如铁)制成。稍作变化,定子402可制成永磁体形式,使得磁盘404和406彼此吸引。由于永磁体的存在,两个磁片404、406总是接合的。使用永磁体不能提供如同上述电磁离合器构造那样精确的扭矩控制。但是永磁体具有以下优点:(1)不需要控制器或控制逻辑电路来控制通过线圈的电流;(2)与电磁离合器相比,构造更加紧凑;以及(3)简化了器械10的设计。
如之前所述,端部执行器12可发射RF能量以凝结夹紧在端部执行器中的组织。RF能量可在端部执行器12的电极之间传递。RF源(未示出)除了包括其它部件外还包括例如振荡器和放大器,RF源可将RF能量提供给电极,RF源可设置在器械本身中,诸如设置在无绳器械10的手柄6中,或者RF源可位于器械10的外部。RF源可被激活,如下面更详细地描述。
根据各种实施方式,端部执行器12可包括多个电极部分(分段)。例如,如图23的例子所示,砧座24的底面(即:面向钉仓34的表面)可包括三个共线的分段。在该实施方式,每个分段具有相同长度(例如20mm),但是在其它实施方式中,可以存在更多或更少的分段,并且分段可具有不同长度。在图23的例子中,三对有源或“阳极”端子或电极500沿着通道长度的每一侧在砧座24的底面上纵向地排成直线。具体而言,在所示的实施方式中,在刀通道516的两侧上存在一对远侧电极5001、一对中间电极5002和一对近侧电极5003。端部执行器12或者金属砧座24的金属外部部分或通道22可用作所述三个上部有源电极(或阳极)500的每个的对电极(或阴极)。上部电极500可连接到RF源。当通电时,RF能量可在上部电极500和对电极之间传导,从而使夹在电极之间的组织凝结。
电极500可被同时通电或者以不同次序(诸如顺序地)通电。对于电极500按顺序被通电的实施方式,顺序可以是自动的(例如通过与RF源通信的控制器(未示出)控制)或者通过用户选择。例如,近侧电极5003可首先通电;然后是中间电极5002;随后是远侧电极5001。这样,操作者(例如手术医生)可选择性地凝结钉线区域。在这样的实施方式中,电极可由多路复用器和/或多个输出发生器来控制,如下面更详细地描述。这样,每个电极500下面的组织可根据凝结需要单独地处理。成对电极的每个都可连接到RF源上,使得电极可同时被通电。因此,对于远侧的有源电极5001对,处于刀通道的相对侧上的每个电极可通过RF源同时通电。这同样适用于中间的电极5002对和近侧的电极5003对,但是在电极对被顺序通电的实施方式中,远侧的电极对与中间的电极对和近侧的电极对不是同时被通电,等等。
另外,各种电参数(诸如阻抗、输出功率或能量等)可被监控并且特定电极500的输出可被修改以产生最需要的组织效应。此外,另一优点是,如果前一次器械击发或外科手术留下可能引起电极短路的金属钉或其它导电物体,这样的短路情况可通过发生器和/或多路复用器进行检测,并且能量可以以适合短路的方式进行调制。
另外,与具有和如图23所示三段电极500的组合长度同样长的一组电极的设计相比,顺序地给电极500通电减少了需要从RF源获得的瞬时功率。例如,对于在‘312号专利中所示的电极构型,已经证明需要五十至一百瓦特才能在切割线的两侧成功凝结四十五毫米的线。通过使用与较大的返回电极(例如金属砧座24)的表面积相比具有较小表面积的较小有源电极(例如上部电极500),较小的有源电极500可将治疗能量集中在组织处,而较大的返回电极被用于以对组织界面影响极小的方式连通电路。此外优选地,返回电极具有较大质量,由此能够在电外科应用中保持温度较低。
电极500可被电绝缘材料504包围,电绝缘材料504可包括陶瓷材料。
图24示出了具有分段RF电极的另一实施方式。在如图24所示的实施方式中,存在四个共线的等长(在该例子中为15mm)的分段电极5001-4。与图23的实施方式相似,图24的电极500可被同时通电或顺序通电。
图25示出了另一种实施方式,其中分段电极具有不同长度。在所示的实施方式中,存在四个共线的分段电极,但是最远侧的电极5001、5002的长度为10mm,而两个近侧电极5003、5004的长度为20mm。如上所示,短的远侧电极可提供使治疗能量集中的优点。
图59示出了在砧座24的底面上(即面向通道22的表面)上具有处于电路板570或其他类型的适当基片上的十五对分段RF电极500的实施方式。通过RF源(或发生器)574给各电极通电。多路复用器576可在控制器578的控制下根据需要将RF能量分配给各电极对。根据各种实施方式,RF源574、多路复用器576和控制器578可被设置在器械的手柄6中。
在这样的实施方式中,电路板570可包括多个层,所述层在多路复用器576和各电极对之间提供电连接。例如,如图60至图63所示,电路板可包括三个层5801-3,每一层580提供至五个电极对的接线。例如,最上层5803可提供至最近侧的五个电极对的接线,如图60至61所示;中间层5802可提供至中间的五个电极对的接线,如图60至62所示;最下层5801可提供至最远侧的五个电极对的接线,如图60至63所示。
图64示出了根据这样的实施方式的砧座24的剖切端视图。与钉槽口584邻接的电路板570包括三个传导层5801-3,在所示传导层5801-3之间具有绝缘层5821-4。图65和66示出了各个层5801-3可如何堆叠以接回到手柄中的多路复用器576。
如图67所示,在端部执行器12中具有如此多的RF电极的优点在于,如果前一次器械击发或外壳手术在组织592中留下可能引起电极短路的金属钉线590或其他导电物体,这样的短路可被发生器和多路复用器检测到,并且能量可以以适合于短路的方式进行调制。
图27示出了带有RF电极的另一种端部执行器12。在该实施方式中,端部执行器12仅包括远侧电极5001,金属砧座24用作返回电极。远侧电极5001并不在砧座24的整个长度上延伸,而仅仅在所述长度的一部分延伸。在所示的实施方式中,远侧电极5001沿着60mm的砧座的长度仅大约为20mm,因此远侧电极5001大约仅覆盖砧座长度最远侧的三分之一。在其他实施方式中,远侧电极5001可覆盖砧座长度最近侧的十分之一至二分之一。这样的实施方式可用于点式凝结,如在美国专利5,599,350中所描述的那样,该美国专利通过引用结合入本文。
图28示出了带有RF电极的端部执行器12的另一种实施方式。在该实施方式中,有源电极500被定位在砧座24的远侧尖端上,通过不导电的绝缘体504与砧座24绝缘,绝缘体504可由陶瓷材料制成。这样的实施方式可用于点式凝结。
图29至32示出了端部执行器12的对点式凝结有用的其他实施方式。在这些实施方式中,砧座24包括位于砧座24的远端并且沿着砧座24的侧面的一对电极5001、5002。图29是根据这样的实施方式的砧座24的前端视图,图30是侧视图,图31是局部放大的前端视图,而图32是顶视图。在这样的实施方式中,金属砧座24可用作返回电极。有源电极5001、5002可通过不导电的绝缘体504相对于砧座24绝缘,绝缘体504可包括陶瓷材料。
图33至36示出了一种实施方式,其中砧座24包括位于砧座24的顶部中央的两个远侧电极5001、5002。此外,金属砧座24可用作返回电极,有源电极5001、5002可通过不导电的绝缘体504相对于砧座24绝缘。
图37至40示出了一种实施方式,其中一个有源电极5001(例如有源电极)被定位在砧座24上,而另一个有源电极5002被定位在下钳口22上,优选地定位在钉仓34上。金属砧座24可用作返回电极。砧座电极5001通过绝缘体504相对于砧座24绝缘。电极5002被定位在钉仓34中,钉仓34优选地由诸如塑料的不传导材料制成,电极5002通过钉仓34相对于金属通道22绝缘。
图41至44示出了一种实施方式,其中砧座24具有位于砧座24的最远端处的两个有源电极5001、5002,所述有源电极5001、5002从砧座24的顶面完全延伸到底面。此外,金属砧座24可用作返回电极,并且有源电极5001、5002可通过不导电的绝缘体504相对于砧座24绝缘。
图45至48示出了一种实施方式,其中钉仓34具有在钉仓34的最远端处的两个有源电极5001、5002。在这样的实施方式中,金属砧座24或金属通道22可用作返回电极。在示出的实施方式中,电极5001、5002被连接到绝缘嵌件503,但是在其他实施方式中,绝缘嵌件503可被省去并且塑料钉仓34可用作电极5001、5002的绝缘体。
图49至52示出了在砧座24的最远端具有一个有源电极5001并且在钉仓34的最远端具有另一个有源电极5002的实施方式。此外,在这样的实施方式中,金属砧座24或金属通道22可用作返回电极。在示出的实施方式中,电极5002被连接到绝缘嵌件503、505,但是在其他实施方式中,绝缘嵌件503、505可被省去并且塑料钉仓34可用作电极5002的绝缘体。
图57是根据本发明的其他实施方式的手柄6的侧视图,而图58是根据本发明的其他实施方式的手柄6的侧剖视图。示出的实施方式仅包括扳机,闭合扳机18。在该实施方式中,刀、钉驱动器和/或RF电极的激活可通过除单独击发扳机外的部件实现。例如,如图57所示,刀、钉驱动器和/或RF电极的致动可通过按钮开关540或其他形式的开关来激活,所述开关处在便于操作者的位置中。在图57中,所示开关540在手柄6的最近侧部分处。在另一种实施方式中,开关可被设置在手柄6的远端附近,使得拉动管口539会激活开关,引起器械的致动。在这样的实施方式中,开关(未示出)可被设置在管口539下面或附近,使得管口的运动会拨动开关。
替代地,刀、钉驱动器和/或RF电极的致动可通过由麦克风542检测到的语音或其他声音指令来激活。在其他实施方式中,手柄6可包括RF或声收发器541,该收发器541可接收和/或传递RF或声信号以激活器械。同样,如图58所示,脚踏开关或开关544可被用于激活器械10。脚踏开关544可通过绳545连接到手柄上。同样,手柄6可包括拨盘式控制器546或用于控制分段RF电极的致动的其他适当的控制装置(见例如图23和24)。操作者可使用这样的控制装置546连续地激活端部执行器12中的各个RF电极对500。
图57和58中所示的器械10还包括多个用户反馈系统。如上所述,器械10可包括用于使操作者听见指令或指示的扬声器543。另外,手柄6可包括视觉指示器548,诸如LED或其他光源,视觉指示器提供与各个分段RF电极的致动有关的视觉反馈。例如,每个视觉指示器548可对应于一个分段RF电极对。当分段RF电极对被激活时,相应的视觉指示器548可被激活。另外,手柄6可包括字母数字式显示器550,其可以是例如LED或LED显示器。显示器550可连接到手柄6内部的电路板552上。手柄6还可包括位于手枪式握把26中的振动器554,该振动器554可给操作者提供振动反馈。例如,每当端部执行器12中的一对分段RF电极对被激活时,振动器554可振动。
图26是根据各种实施方式的端部执行器12的剖视图,在这些实施方式中,电极位于上钳口(或砧座)24上。在示出的实施方式中,有源电极500被设置在刀槽516附近。金属砧座24可用作返回电极。可由陶瓷制成的绝缘体504将电极500相对于金属砧座24绝缘。除了电极500被制得较小使得绝缘体504可在各个电极500和刀槽516的边缘之间延伸外,图68的实施方式类似于图26的实施方式。
图53是根据另一种实施方式的端部执行器12的剖切端视图。在该实施方式中,与图26的实施方式相似,有源电极5001、5002在砧座24上并且在刀通道的相对侧上。电极5001、5002通过绝缘体504相对于金属砧座绝缘,绝缘体504再次优选地包括陶瓷材料。但是,在该实施方式中,绝缘体504被制得很薄(与图26相比)。将绝缘体504制得很薄提供了潜在优点,即砧座24可包括在电极500上面的相对较大的金属部分520,由此在给定砧座刚度时可支持较细长的砧座外形,或者在给定砧座横截面尺寸时可支持刚性较好的外形。绝缘体504可被铸造在砧座24中或者溅射涂覆在砧座24上。
图54示出了另一种实施方式。在该实施方式中,有源电极5001、5002被溅射涂覆或粘接到绝缘体504上,绝缘体504也可被溅射涂覆或粘接到砧座24上。与图53的实施方式相同,该设计允许在电极上使用更多的砧座材料。在该实施方式中,电极5001、5002可包括银,银是优良的电导体并且具有抗菌特性。
图55示出了根据另一种实施方式的端部执行器的侧视图。在该实施方式中,电绝缘材料薄膜530被沉积在钉仓34的表面上。绝缘膜530优选地包括耐热且耐电弧材料,诸如陶瓷。这倾向于增加钉仓34的耐电弧轨迹和耐短路性能,从而在更换钉仓34之间允许更多的击发次数。另外,如果钉仓34是不良导电体,就可以支持组织的较快加热并且减少总能量需求量。有源电极(在图55中没有示出)可以在砧座24中,如上面的实施方式所述。
图56示出了与图55所示的实施方式相似的实施方式,除了在图56中稍微导电的材料薄层532被沉积在绝缘膜530上。稍微导电的薄层532的导电性可低于夹紧在端部执行器12中以便治疗的组织的导电性。因此,稍微导电的薄层532可提供传导率减少的路径,以提供对被夹紧的组织的附加加热。这将易于减少加热组织和实现凝结所需的时间。
如上所述,器械10可包括用于使端部执行器12关节运动的关节运动枢轴14。器械10的医生或操作者可通过利用关节运动控制器16使端部执行器12相对于轴8关节运动,如在Geoffrey C.Hueil等人的公开号为No.2007/0158385 A1,题为“Surgical Instrument HavingAn Articulating End Effector”的美国专利申请更详细地描述,该申请通过引用结合在本文中。在其他实施方式中,不是通过与器械10为一体的控制装置,而是可通过单独器械(诸如夹子)使端部执行器12关节运动,单独器械被插入患者体内,使得单独器械的操作部分接近端部执行器12,从而可根据需要使端部执行器12关节运动。单独器械可通过与端部执行器12不同的开口或相同的开口被插入。同样,不同操作者可操作单独器械,或者一个人可操作两种器械以使端部执行器12关节运动。在另一种无源关节运动场景中,端部执行器12可通过谨慎地将其推靠在患者的其他部分上而做关节运动,以实现期望的关节运动。
在另一种实施方式中,端部执行器12可通过柔性电缆连接到手柄。在这样的实施方式中,端部执行器12可通过使用另一种器械(例如单独的夹子器械)来根据需要定位和保持就位。另外,在其他实施方式中,端部执行器12可通过单独器械来定位并且通过第二单独器械来夹紧。另外,端部执行器12可被制得足够小,诸如8mm至9mm宽和10mm至11mm高,使得拉近(pull-to-close)机构可被用于从手柄6夹紧端部执行器。该拉近机构可从题为“Cable-ActuatedJaw Assembly For Surgical Instruments”的美国专利5,562,701所述的那个机构改装,该专利通过引用结合入本文。电缆600可被设置在柔性内窥镜中或沿着柔性内窥镜设置,以供例如在上或下胃肠道手术中使用。
在另一种实施方式中,如图69和70所示,器械10可包括柔性颈部组件732,该颈部组件使得端部执行器12能够做关节运动。当连接到轴8上的关节运动传递组件731旋转时,可引起柔性颈部组件732做间接的关节运动。柔性颈部组件732可包括容纳第一柔性带组件735和第二柔性带组件736的第一柔性颈部部分733和第二柔性颈部部分734。在关节运动传递组件731的旋转时,第一柔性传动带组件735和第二柔性传动带组件736中的一个向前运动,而另一个带组件向后运动。响应于带组件在柔性颈部组件732的第一和第二柔性颈部部分733、734内的往复运动,柔性颈部组件732弯曲以提供关节运动。柔性颈部在美国专利5,704,534中进一步描述,该专利通过引用结合入本文。
这里所公开的装置可以是一次性使用的,也可以设计成多次使用。然而,在任何一种情况下,在至少一次使用之后,该装置可被修复以重新使用。修复可包括装置的拆卸、接着清洗或更换特定部件和随后的重新组装这些步骤的任意组合。特别地,该装置可以被拆卸,任何数量的特定部件或零件可以有选择地以任意组合被更换或去除。在清洗和/或替换特定部件之后,该装置可在修复设备中或在即将进行手术程序之前由手术队进行重新组装以便以后使用。本领域技术人员将会理解对该装置的修复可利用用于拆卸、清洗/替换、和重新组装的各种技术。这些技术的使用以及产生的修复好的装置也全都在本申请的保护范围内。
优选地,在本文中公开的本发明的各种实施方式将在外科手术前被处理。首先,获取新的或者使用过的器械并在需要的情况下对其进行清洁。该器械然后进行灭菌。在一种灭菌工艺中,器械被放置在闭合且密封的容器中,诸如覆有高密度聚乙烯合成纸的塑料壳。容器和器械然后被放置在可穿透容器的辐射场中,诸如γ射线、x射线或者高能电子。辐射杀死器械上以及容器中的细菌。灭菌后的器械然后可被储存在无菌容器中。密封的容器保持器械处于无菌状态,直到其在医学场合下被打开。
优选的是装置被灭菌。这可通过本领域已知的任何数目的方式来实现,包括β或γ射线、环氧乙烷、蒸汽或其他方法。
虽然通过若干实施方式的描述展示了本发明并且很具体地描述了示出的实施方式,但是申请人并不是将附带的权利要求书的范围约束或以任何方式限制得如此具体。本领域技术人员很容易想到另外的有优点和修改。本发明的各种实施方式表现出了优于现有钉合方法的巨大改进,现有钉合方法需要在单个钉仓中使用不同尺寸的钉来实现具有不同成形(最终)高度的钉。
因此,在内窥镜手术和器械方面描述了本发明。但是,本文所用的诸如“内窥镜”的术语不应当被认为将本发明限制在仅供结合内窥镜管(即套管针)使用的外科钉合和切割器械。相反,本发明可在入口被限制的任何手术中使用,包括但不限于腹腔镜手术以及开放式手术。而且,本发明的各种钉仓实施方式的独特且新颖的方面可在结合其他形式的钉合设备使用时有用,而不脱离本发明的主旨和范围。

Claims (10)

1.一种外科切割和紧固器械,包括:
端部执行器;
连接到所述端部执行器的轴,所述轴包括用于给所述端部执行器提供动力的传动系统;和
连接到所述轴的手柄,所述手柄包括:
直流电动机,该电动机连接到所述传动系统以给所述传动系统提供动力;
多个串联的直流功率源,所述直流功率源连接到所述电动机以给所述电动机提供电力;和
功率源选择开关,所述功率源选择开关在第一状态时将所有的所述直流功率源连接到所述电动机,并且在第二状态时将所述直流功率源的一部分连接到所述电动机。
2.如权利要求1所述的外科切割和紧固器械,其中,所述功率源选择开关包括机电开关。
3.如权利要求1所述的外科切割和紧固器械,其中,所述功率源选择开关包括固态开关。
4.如权利要求1所述的外科切割和紧固器械,其中,所述端部执行器包括圆形切割端部执行器。
5.如权利要求1所述的外科切割和紧固器械,其中,所述端部执行器包括线性切割端部执行器。
6.一种外科切割和紧固器械,包括:
端部执行器;
连接到所述端部执行器的轴,所述轴包括用于给所述端部执行器提供动力的传动系统;和
连接到所述轴的手柄,所述手柄包括:
直流电动机,该电动机连接到所述传动系统以给所述传动系统提供动力;
直流功率源;和
功率调节器,该功率调节器具有与所述直流功率源连接的输入和与所述电动机的输入连接的输出。
7.如权利要求6所述的外科切割和紧固器械,其中,所述直流功率源包括至少一个电池。
8.如权利要求6所述的外科切割和紧固器械,其中,所述直流功率源包括至少一个蓄电装置。
9.如权利要求8所述的外科切割和紧固器械,其中,所述至少一个蓄电装置包括至少一个超级电容器。
10.如权利要求6所述的外科切割和紧固器械,其中,所述功率调节器包括直流-直流功率转换器。
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US20210068832A1 (en) 2021-03-11
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EP2465443A3 (en) 2013-03-27
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