CN101234032B - 具有增强的电池性能的外科器械 - Google Patents
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Abstract
本发明涉及具有增强的电池性能的外科器械。具体地说,涉及一种包括外科器械诸如内镜或者腹腔镜器械的部件的组件。所述组件可包括包装件、包装件中的外科器械部件和包装件中的动力源。所述动力源可与外科器械部件电连接。所述组件还包括包装件中的辅助动力源和电路元件,其中所述电路元件与所述动力源和辅助动力源电连接。
Description
本申请涉及下列同时提交的美国专利申请,这些申请通过引用全文结合入本文:
(1)J.Giordano等人的序列号为_____、发明名称为“SURGICALINSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNITAND SENSOR TRANSPONDERS”的美国专利申请(代理卷号060338/END5923USNP);
(2)J.Giordano等人的序列号为_____、发明名称题为“SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEENCONTROL UNIT AND REMOTE SENSOR”的美国专利申请(代理卷号060339/END5924USNP);
(3)J.Giordano等人的序列号为_____、发明名称为“SURGICALINSTRUMENT WITH ELEMENTS TO COMMUNICATE BETWEEN CONTROL UNITAND END EFFECTOR”的美国专利申请(代理卷号060340/END5925USNP);
(4)F.Shelton等人的序列号为_____、发明名称为“PREVENTION OF CARTRIDGE REUSE IN A SURGICAL INSTRUMENT”的美国专利申请(代理卷号060341/END5926USNP);
(5)J.Swayze等人的序列号为_____、发明名称为“POST-STERILIZATION PROGRAMMING OF SURGICAL INSTRUMENTS”的美国专利申请(代理卷号060342/END5924USNP);和
(6)F.Shelton等人的序列号为_____、发明名称为“INTERLOCKAND SURGICAL INSTRUMENT INCLUDING SAME”的美国专利申请(代理卷号060343/END5928USNP)。
技术领域
本发明涉及具有增强的电池性能的外科器械。具体地说,涉及一种包括外科器械诸如内镜或者腹腔镜器械的部件的组件。
背景技术
由于切口较小能够缩短术后恢复时间并减少并发症,内镜外科器械通常比传统的开放式外科装置更受欢迎。因此,内镜外科器械领域已经有了显著发展,适于通过套管针的套管将远端执行器精确地放置在所需的外科手术部位。这些远端执行器以多种方式接合组织,以获得诊断或治疗效果(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、RF、激光等的能量装置)。
已知的外科缝合器包括能够同时在组织中切割纵向切口并且在该切口的相对侧施加缝钉线的端部执行器。所述端部执行器包括一对协作的钳口构件,如果该器械用于内镜或腹腔镜应用,所述钳口构件能够通过套管通道。其中一个钳口构件容纳钉仓,该钉仓具有至少两排横向隔开的缝钉。另一个钳口构件限定钉砧,该钉砧具有与钉仓中的成排缝钉对准的钉成形槽。所述器械包括多个往复运动楔形件,当被向远侧驱动时,所述楔形件经过钉仓中的开口并与支承缝钉的驱动器接合,以便向着钉砧击发缝钉。
在美国专利US 5,465,895中描述了适用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,临床医生能够将钳口构件闭合在组织上,以在击发前定位组织。一旦临床医生确认钳口构件正确夹持组织,操作者可以单击发冲程击发该外科缝合器,从而切割和缝合组织。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,临床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。
随着每次更新换代,内镜缝合器/切割器的复杂性和功能都不断增加。这种现象的一个原因是需要将击发力(FTF)降低到所有或者绝大多数外科医生可操纵的水平。降低FTF的一种已知的解决办法是使用CO2马达或者电动马达。但由于不同原因,这些装置并不比传统的手动装置更合理。外科医生通常更喜欢体验与端部执行器在成形缝钉时经受的力成比例的力分布,以保证它们完成切割/钉合过程,并且力的上限在大多数外科医生的能力之中(通常大约为15-301bs)。他们通常还想保持对缝钉的展开的控制,以及当感觉在操纵装置的过程中感受到的力太大或者因为一些其它临床原因时能够在任何时候停止。
为了解决这种需要,已经开发出了所谓的“动力辅助”内镜外科器械,其中辅助功率源用于帮助击发器械。例如,在一些动力辅助装置中,马达为用户挤压击发扳机产生的功率输入提供辅助动力源。所述装置能够为操作人员提供负载力的反馈和控制,以减小为了完成切割操作而需要由操作人员施加的击发力。在通过引用接合入本文的Shelton等人于2006年1月31日提交的序列号为11/343573、发明名称为“Motor-driven surgical cutting andfastening instrument with loading force feedback”(“‘573申请”)的美国专利申请中描述了这种动力辅助装置。
内镜外科器械的复杂性和功能增加的另一原因是需要监视器械部件并提供对器械部件的增强控制。例如,传感器和控制系统现在被用于在外科器械中执行新的功能,包括例如电子锁定装置。例如,在Swayze等人于2006年1月31日提交的序列号为11/343439、发明名称为“Electronic Lockouts And Surgical InstrumentIncluding Same”的美国专利申请中描述了一种所述的锁定装置,该申请通过引用结合入本文。
在任何种类的外科器械中使用电子装置的一个挑战是提供合适的动力源。大多数外科器械被储存在密封、无菌包装件中。因此,在器械被包装后为了验证其动力源状态或者在需要时补充动力而接触器械通常是不切实际的。因而,器械的储藏期限受到动力源能够可靠地保持电荷的时间的限制。可是,对于许多种器械而言,需要选择具有高峰功率输出的动力源。高峰功率输出使动力源更适于驱动用在外科器械中的马达、传感器和控制系统。但是,具有高峰功率输出的动力源诸如锂离子电池通常不能保持适当长时间的满电荷。因此,动力源的选择必须折中高峰动力源的需要以及长存储寿命的相应需要。
发明内容
在一个总的方面,本发明涉及包括外科器械诸如内镜或者腹腔镜器械的部件的组件。该组件可包括包装件、包装件中的外科器械部件和包装件中的动力源。该动力源可与外科器械部件电连接。该组件还可包括位于包装件中的辅助动力源和电路元件,其中该电路元件与动力源和辅助动力源电连接。
在另一个总的方面,本发明涉及与外科器械一起使用的端部执行器钉仓。端部执行器钉仓可以包括电气部件、动力源和电路元件。该电路元件可被构造成当端部执行器钉仓被安装在外科器械中时与动力源和电气部件电连接。
在又一个总的方面,本发明涉及包括包装件和处于包装件中的端部执行器钉仓的组件。端部执行器钉仓可以包括电气部件。该组件也可以包括位于包装件中的动力源和位于包装件中的电路元件。该电路元件可被构造成当端部执行器钉仓被安装在外科器械中时与动力源和电气部件电连接。本发明还公开了修复外科器械及其部件的方法。
更具体地说,本发明涉及如下方面:
(1)、一种组件,包括:
包装件;
位于所述包装件中的外科器械部件;
位于所述包装件中的动力源,其中所述动力源能够与所述外科器械部件电连接;
位于所述包装件中的辅助动力源;和
电路元件,其与所述动力源和辅助动力源电连接。
(2)、根据第(1)项所述的组件,其中所述包装件被灭菌。
(3)、根据第(1)项所述的组件,其中所述动力源是电池组。
(4)、根据第(1)项所述的组件,其中所述电池组包括至少一个电池,所述至少一个电池选自包括锂离子电池和镍金属氢化物电池的组。
(5)、根据第(1)项所述的组件,其中所述动力源是电容器。
(6)、根据第(1)项所述的组件,其中所述电路元件包括位于所述动力源和辅助动力源之间的直接电连接件。
(7)、根据第(6)项所述的组件,其中所述直接电连接件包括感应连接件。
(8)、根据第(1)项所述的组件,其中所述电路元件包括控制电路,该控制电路对所述动力源和辅助动力源之间的电连接进行调节。
(9)、根据第(8)项所述的组件,其中控制电路包括位于所述辅助动力源和动力源之间的开关。
(10)、根据第(9)项所述的组件,其中所述开关被构造成当打开包装件时闭合。
(11)、根据第(9)项所述的组件,其中所述开关包括可拆卸的凸片。
(12)、根据第(8)项所述的组件,其中所述控制电路包括微处理器。
(13)、根据第(12)项所述的组件,其中所述微处理器还被构造成在外科器械的使用过程中控制外科器械的至少一个部件。
(14)、根据第(1)项所述的组件,其中所述外科器械部件包括内切割器。
(15)、根据第(1)项所述的组件,其中所述外科器械部件包括用于外科器械的端部执行器钉仓。
(16)、根据第(1)项所述的组件,其中所述动力源不与所述器械部件电连接。
(17)、根据第(1)项所述的组件,其中所述辅助动力源包括选自如下组的至少一个电池,所述组包括锌/碳电池,锌/碱/二氧化锰电池,锂/二氧化锰电池,锌/氧化银电池和锂/二硫化铁电池。
(18)、一种用于外科器械的端部执行器钉仓,所述端部执行器钉仓包括:
电气部件;
动力源;和
电路元件,当端部执行器钉仓被安装在外科器械中时该电路元件与动力源和电气部件电连接。
(19)、根据第(18)项所述的端部执行器钉仓,其中所述电气部件包括由无源传感器和有源传感器组成的组中的至少一个。
(20)、根据第(18)项所述的端部执行器钉仓,其中所述电气部件包括射频识别(RFID)部件。
(21)、根据第(18)项所述的端部执行器钉仓,其中所述电气部件用于指示包括端部执行器钉仓的状态、端部执行器钉仓和与端部执行器钉仓兼容的外科器械的类型的组中的至少一个。
(22)、根据第(18)项所述的端部执行器钉仓,其中所述电路元件包括开关,该开关被构造成当端部执行器钉仓安装在外科器械中时接通所述电气部件和动力源之间的电连接。
(23)、根据第(18)项所述的端部执行器钉仓,其中所述电路元件包括至少两个电极,其中当钉仓被安装在外科器械中时在所述电极之间形成电连接。
(24)、根据第(18)项所述的端部执行器钉仓,其中所述电路元件包括接触开关,其被构造成当端部执行器钉仓被安装在外科器械中时被致动。
(25)、一种组件,包括:
包装件;
位于所述包装件中的端部执行器钉仓,其中端部执行器钉仓包括电气部件;
位于所述包装件中的动力源;和
位于所述包装件中的电路元件;其中该电路元件可被构造成当端部执行器被安装在外科器械中时将动力源和电气部件电连接。
(26)、根据第(25)项所述的组件,其中所述包装件被灭菌。
(27)、根据第(25)项所述的组件,其中所述电路元件包括开关,该开关被构造成当端部执行器钉仓被安装在外科器械中时接通所述电气部件和动力源之间的电连接。
(28)、一种处理端部执行器钉仓的方法,所述方法包括:
获得第(18)项所述的端部执行器钉仓;
对所述端部执行器钉仓进行灭菌;和
将所述端部执行器钉仓存储在无菌包装件中。
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3至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是根据本发明的各种实施方式的外科器械的透视图;
图12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13是在根据本发明的各种实施方式的器械中使用的端部执行器的侧视图;
图14至16显示了处于根据本发明的各种实施方式的无菌包装件中的器械;
图17至19显示了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20显示了处于根据本发明的各种实施方式的无菌包装件中的器械的部件;和
图21显示了根据本发明的各种实施方式的器械的部件。
具体实施方式
本发明的各种实施方式总的涉及具有动力源的外科器械和/或器械部件,当所述器械和/或部件被密封在无菌包装件中时所述动力源的电量可被施加或者保持。本发明可被用于任何类型的包括至少一个动力源的外科器械,诸如内镜或者腹腔镜外科器械。在描述系统的各个方面之前,首先以图示的方式描述了可使用本发明的实施方式的一种类型的外科器械-内镜缝合和切割器械(即内切割器)。
图1和2示出了内镜外科器械10,其包括手柄6、轴8和关节运动端部执行器12,该端部执行器12在关节枢轴14处与轴8枢转式连接。端部执行器12的正确设置和定向可通过手柄6上的控制器简化,所述手柄包括(1)旋钮28,所述旋钮28用于旋转在轴8的自由旋转接头29处的闭合管(以下结合图4至5更详细地描述),从而转动端部执行器12,和(2)关节运动控制器16,所述关节运动控制器16用于使端部执行器12围绕关节枢轴14进行旋转关节运动。在所示的实施方式中,端部执行器12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器械的端部执行器,例如抓钳、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。应当理解,具有针对不同外科任务的端部执行器的器械可具有用于操作端部执行器12的不同数目或类型的扳机或者其它合适的控制器。所示端部执行器12通过优选的细长轴8与手柄6间隔。在一种实施方式中,器械10的临床医生或者操作人员可通过使用如在Hueil等人2006年1月10日提交的序列号为11/329020、发明名称为“Surgical Instrument Having An Articulating EndEffector”的未决美国专利申请中更详细描述的关节运动控制器16使端部执行器12相对于轴8进行关节运动,该专利申请通过引用结合入本文。
在该例子中,除其它部件外,端部执行器12还包括缝钉通道22和可枢转运动的钳口构件诸如钉砧24(它们保持确保有效夹钳并缝合被夹钳在端部执行器12中的组织的间隔)。手柄6包括手枪式握把26,临床医生朝着所述握把26可枢转地拉动闭合扳机18,以引起钉砧24向着端部执行器12的缝钉通道22夹钳或关闭,从而夹钳定位在钉砧24和通道22之间的组织。击发扳机20在闭合扳机18的更外侧。一旦闭合扳机18被锁定在关闭位置中,击发扳机20可略微向着手枪式握把26旋转,使操作人员用一只手就能够到击发扳机20。然后操作人员可向着手枪式握把12枢转地拉动击发扳机20,以引起夹钳在端部执行器12中的被夹钳组织的缝合和切割。‘573专利申请描述了用于锁定和解锁闭合扳机18的各种构造。在其它实施方式中,除钉砧24以外还可使用不同类型的钳口构件,例如对置的钳口等。
应理解,术语“近侧”和“远侧”在本文中以握持器械10的手柄6的临床医生为参照。因此,端部执行器12相对于更近侧的手柄6为远侧。还应理解,出于方便和清楚起见,在本文中相对附图使用空间术语例如“垂直”和“水平”。但是,外科器械能以多种朝向和位置使用,这些术语并不意味限制和绝对化。
可首先致动闭合扳机18。一旦临床医生对端部执行器12的定位感到满意,临床医生可向后拉动闭合扳机18使其到达靠近手枪式握把26的完全关闭的锁定位置。然后可致动击发扳机20。当临床医生除去压力时,击发扳机20恢复到打开位置(在图1和2中显示)。当按压位于手柄6上、在该例子中为手柄的手枪式握把26上的释放按钮30时,可释放闭合扳机18。
图3是根据各种实施方式的端部执行器12的分解图,如示出的实施方式中所示,除前面提到的通道22和钉砧24之外,端部执行器12还可包括切割器械32、滑块33、可拆卸地安放在通道22中的钉仓34和螺纹轴36。切割器械32可例如为刀。钉砧24可在与通道22的近端连接的枢轴点25处枢转地打开和关闭。钉砧24还可包括在其近端的凸片27,该凸片27被插入机械闭合系统(下面进一步描述)的部件中以打开和关闭钉砧24。当闭合扳机18被致动时,也就是说,由器械10的操作人员向内拉动时,钉砧24可围绕枢轴点25枢转至夹钳位置或关闭位置。如果端部执行器12的夹钳令人满意,操作人员可致动击发扳机20,引起刀32和滑块33沿着通道26纵向行进(将在下面更详细解释),从而切割夹钳在端部执行器12中的组织。滑块33沿着通道22的运动导致钉仓34的缝钉被驱动穿过被切割的组织并抵靠钉砧24,这使缝钉紧固被切割组织。发明名称为“Surgical stapling instrument incorporating an E-beam firingmechanism”的美国专利US 6,978,921提供了关于所述双冲程切割和紧固器械的更详细情况,该申请通过引用结合入本文。滑块33可以是钉仓34的一部分,当刀32在切割操作之后回缩时,使滑块33不回缩。通道22和钉砧24可由导电材料(诸如金属)制成,并在各种实施方式中可用作天线的一部分以便与端部执行器中的传感器通信。钉仓34可由不导电材料(诸如塑料)制成并且传感器可与钉仓34连接或者设置在其中,见下面的进一步描述。
应当注意,虽然在本文中描述的器械10的实施方式采用缝合被切割组织的端部执行器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,也可使用利用RF能量或者粘附剂来紧固被切割组织的端部执行器。Yates等人的发明名称为“Electrosurgical Hemostatic Device”的美国专利5,709,680和Yates等人的发明名称为“Electrosurgical Hemostatic DeviceWith Recessed And/Or Offset Electrodes”的美国专利5,688,270公开了使用RF能量来紧固被切割组织的切割器械,这两份专利均通过引用结合入本文。Morgan等人的序列号为11/267811的美国专利申请和Shelton等人的序列号为11/267383的美国专利申请公开了使用粘附剂来紧固被切割组织的切割器械,这两份专利申请也都通过引用结合入本文。因此,虽然在本文中的描述指的是切割/缝合操作以及类似操作,应当认识到这只是示例性实施方式而不意味着限制。其它组织紧固技术也可被使用。
图4和5是根据各种实施方式的端部执行器12和轴8的分解图,图6是根据各种实施方式的端部执行器12和轴8的侧视图。如阐述的实施方式中所示,轴8可包括由枢轴连接件44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,钉砧24上的凸片插入该开口45中以便打开和关闭钉砧24。设置在闭合管40、42内部的可以是近侧脊管46。设置在近侧脊管46内部的可以是主旋转(或者近侧)传动轴48,该传动轴48经由锥齿轮组件52与次级(或者远侧)传动轴50连接。次级传动轴50与传动齿轮54连接,该传动齿轮54啮合螺纹轴36的近侧传动齿轮56。垂直锥齿轮52b可安放在近侧脊管46的远侧的开口57中并在其中枢转。远侧脊管58可被用于包围次级传动轴50和传动齿轮54、56。总起来说,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)在本文中有时称为“主传动轴组件”。
定位在缝钉通道22的远端处的轴承38承受螺纹轴36,允许螺纹轴36相对于通道22自由旋转。螺纹轴36可与刀32的螺纹开口(未显示)相互作用,从而轴36的旋转导致刀32经过缝钉通道22向远侧或者近侧平移(取决于旋转方向)。因此,当致动击发扳机20引起主传动轴48的旋转时(在下面进一步详细解释),锥齿轮组件52a-c引起次级传动轴50旋转,由于传动齿轮54、56的啮合,轴50的旋转进而引起螺纹轴36的旋转,这引起刀32沿着通道22纵向行进以切割任何夹钳在端部执行器中的组织。滑块33可由例如塑料制成,并可具有倾斜的远侧表面。当滑块33横穿通道22时,向上倾斜的表面可以向上推动或者致动钉仓34中的缝钉穿过被夹钳的组织并抵靠钉砧24。钉砧24将缝钉折回,从而缝合被切割组织。当刀32回缩时,刀32和滑块33可脱离接合,从而将滑块33留在通道22的远端。
如图7至10所示,根据各种实施方式,外科器械可包括手柄16中的电池64。示出的实施方式为操作者提供了有关在端部执行器12中的切割器械34的展开和负载力的反馈。另外,该实施方式可利用由操作人员在回缩击发扳机18时提供的能量为装置10提供动力(所谓的“动力辅助”模式)。如在示出的实施方式中所示,手柄6包括外部下侧件59、60和外部上侧件61、62,它们配合在一起整体上形成手柄6的外部。手柄件59-62可由不导电材料制成,诸如塑料。电池64诸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部分的上部的马达65供电。电池64可根据任何合适的构造或者化学物质构造,包括例如锂离子化学物质诸如LiCoO2或者LiNiO2,镍金属氢化物化学物质等。根据各种实施方式,马达65可以是最大转数约为5000到100,000 RPM的直流电刷驱动马达。马达64可驱动含有第一锥齿轮68和第二锥齿轮70的90度锥齿轮组件66。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可驱动啮合的环形齿轮78,环形齿轮78经由传动轴82驱动螺旋齿轮鼓80。环84可螺纹连接在螺旋齿轮鼓80上。因此,当马达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连接的运转马达传感器110,用于检测操作人员将击发扳机20向着手柄6的手枪式握把26部分拉动(或者“关闭”)从而由端部执行器1 2致动切割/缝合操作的时刻。传感器110可以是比例传感器,例如变阻器或者可变电阻器。当击发扳机20被拉动时,传感器110检测到该运动并发送将表示待施加到马达65的电压(或者功率)的电信号。当传感器110是可变电阻器或者类似装置时,马达65的旋转通常可与击发扳机20的运动量成正比。也就是说,如果操作人员仅仅少量拉动或者关闭击发扳机20,马达65的旋转较小。当击发扳机20完全被拉动(或者处于完全关闭位置),马达65的旋转最大。换言之,操作人员越用力拉动击发扳机20,施加到马达65上的电压就越大,这导致转速越大。在另一种实施方式中,例如,控制单元(在下面进一步描述)基于来自传感器110的输入将脉宽调制控制信号输出到马达65以便控制马达65。
手柄6可包括靠近击发扳机20的上部的手柄中部件104。手柄6还可包括连接在手柄中部件104上的柱和击发扳机20上的柱之间的偏压弹簧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拉动到其打开位置,从而去除传感器110的致动,由此使马达65停止旋转。而且,借助于偏压弹簧112,用户任何时候关闭击发扳机20时都可感受到关闭操作的阻力,从而为用户提供有关由马达65施加的旋转量的反馈。此外,操作人员可停止回缩击发扳机20由此去除来自传感器100的力,从而使马达65停止。因而,操作人员可停止端部执行器12的展开,从而为操作者提供了控制切割/紧固操作的措施。
螺旋齿轮鼓80的远端包括用于驱动环形齿轮122的选侧传动轴120,该环形齿轮122与小齿轮124啮合。小齿轮124与主传动轴组件的主传动轴48连接。如上所述,这样马达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。
螺纹连接在螺旋齿轮鼓80上的环84可包括设置在带槽臂90的槽88中的柱86。带槽臂90具有在其相对端部94处的开口92,该开口92容纳连接在手柄外侧件59、60之间的枢轴销96。枢轴销96也穿过击发扳机20中的开口100和手柄中部件104中的开口102设置。
另外,手柄6可包括反向马达传感器(或者冲程结束传感器)130和停止马达(或者冲程开始)传感器142。在各种实施方式中,反向马达传感器130可以是定位在螺旋齿轮鼓80的远端处的限制开关,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接触并断开(trip)反向马达传感器130。当被致动时,反向马达传感器130将信号发送到控制单元,控制单元将信号发送到马达65使其旋转方向反转,从而在切割操作之后将端部执行器12的刀32退出。
停止马达传感器142例如可以是常通限制开关。在各种实施方式中,该传感器142可以被定位在螺旋齿轮鼓80的近端处,当环84到达螺旋齿轮鼓80的近端时,使环84断开开关142。
在操作时,当器械10的操作人员向回拉动击发扳机20时,传感器110检测击发扳机20的展开并将信号发送到控制单元,控制单元将信号发送到马达65引起马达65例如以与操作人员向回拉动击发扳机20的力度成正比的速率向前旋转。马达65的向前旋转进而引起行星齿轮组件72的远端处的环形齿轮78旋转,从而引起螺旋齿轮鼓80旋转,进而引起螺纹连接在螺旋齿轮鼓80上的环84沿着螺旋齿轮鼓80向远侧行进。螺旋齿轮鼓80的旋转还驱动如上所述的主传动轴组件,进而引起端部执行器12中的刀32的展开。也就是说,引起刀32和滑块33纵向横穿通道22,从而切割被夹钳在端部执行器12中的组织。而且,在使用缝合型端部执行器的实施方式中,引起端部执行器12的缝合操作。
在端部执行器12的切割/缝合操作完成时,螺旋齿轮鼓80上的环84将到达螺旋齿轮鼓80的远端,从而引起反向马达传感器130被致动,传感器130将信号发送到控制单元,控制单元将信号发送到马达65,从而引起马达65的旋转方向反转。这进而引起刀32回缩,还引起螺旋齿轮鼓80上的环84向后运动到螺旋齿轮鼓80的近端。
手柄中部件104包括接合带槽臂90的后侧肩部106(在图8和9中最佳显示)。手柄中部件104还具有与击发扳机20接合的向前运动止动器107。如上面的解释,通过马达65的旋转来控制带槽臂90的运动。当带槽臂90逆时针旋转时,环84从螺旋齿轮鼓80的近端向远端行进,手柄中部件104将逆时针自由旋转。因此,当用户拉动击发扳机20时,击发扳机20将接合手柄中部件104的向前运动止动器107,引起手柄中部件104逆时针旋转。但是,由于后侧肩部106接合在带槽臂90中,手柄中部件104将仅能在带槽臂90允许的范围内逆时针旋转。那样,如果马达65出于一些原因应该停止旋转,带槽臂90将停止旋转,并且使用者将不能进一步拉动击发扳机20,因为手柄中部件104由于带槽臂90将不能逆时针自由旋转。
图7至10中也示出了用于通过回缩闭合扳机18来关闭(或者夹紧)端部执行器12的钉砧24的示例性闭合系统的部件。在所示的实施方式中,闭合系统包括通过销251连接到闭合扳机18的轭形件250所述销251插入穿过闭合扳机18和轭形件250中的对准开口。闭合扳机18围绕其枢转的枢轴销252被插入穿过闭合扳机18的另一个开口,该开口与插入穿过闭合扳机18的销251的开口偏离。因此,闭合扳机18的回缩使闭合扳机18的上部(轭形件250借助销251与闭合扳机18的上部连接)逆时针旋转。轭形件250的远端经由销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。闭合支架256、258一起限定了安放并保持近侧闭合管40的近端(见图4)的开口,闭合支架256、258的纵向运动通过近侧闭合管40引起纵向运动。器械10还包括设置在近侧闭合管40内侧的闭合杆260。闭合杆260可包括窗口261,位于其中一个手柄外部件诸如在所示实施方式中的外侧下侧件59上的柱263被设置在所述窗口261中,以将闭合杆260固定地连接到手柄6上。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,该卡圈267配合在近侧脊管46中的腔269中并由帽271保持在该腔中(见图4)。
在操作时,当轭形件250由于闭合扳机18的回缩而旋转时,闭合支架256、1258引起近侧闭合管40向远侧运动(即远离器械10的手柄),引起远侧闭合管40向远侧运动,这引起钉砧24围绕枢轴点25旋转到夹紧或者关闭位置中。当闭合扳机18从锁定位置解锁时,引起近侧闭合管40向近侧滑动,这引起远侧闭合管42向近侧滑动,借助插在远侧闭合管42的窗口45中的凸片27引起钉砧24围绕枢轴点25枢转到打开或者未夹紧位置中。这样,通过回缩并锁定闭合扳机18,操作人员可夹钳在钉砧24和通道22之间的组织,并可在切割/缝合操作之后通过从锁定位置解锁闭合扳机18来松开组织的夹钳。
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130、142以及运转马达传感器110的输出信号,并可基于输入信号控制马达65。例如,当操作人员在锁定闭合扳机18之后开始拉动击发扳机20时,运转马达传感器110被致动。当钉仓34位于端部执行器12中,钉仓锁定传感器(未示出)可被接通,在这种情况下控制单元可将控制信号输出到马达65引起马达65沿着向前的方向旋转。当端部执行器12到达其冲程末端时,反向马达传感器130将被激活。控制单元可接收来自反向马达传感器130的该输出信号并引起马达65的旋转方向反转。当刀32完全被回缩时,停止马达传感器开关142被激活,控制单元使马达65停止。
在其它实施方式中,与比例型传感器110不同,可使用开关型传感器。在这种实施方式中,马达65的转速与操作人员施加的力不成比例。更确切地说,马达65通常以恒定速度旋转。但是操作人员仍可感受到力反馈,因为击发扳机20配合到齿轮传动链中。
器械10可包括在端部执行器12中的多个传感器以便感测与端部执行器12有关的各种状态,诸如用于确定钉仓34的状态(或与外科器械相关的其它类型的钉仓)、用户输入负载、在关闭和击发过程中缝合器的进展、用于钉仓34的一个或多个可兼容的外科器械等的传感器。传感器可以由感应信号被动供电,或者可通过远程动力源供电,例如端部执行器12中的电池。传感器例如可包括磁阻抗、光学、机电、射频识别(RFID)、微机电系统(MEMS)、运动或者压力传感器。这些传感器可与控制单元300通信,该控制单元300可以例如如图11中所示定位在器械10的手柄6中。传感器可按照任何合适的有线或无线方法与控制单元300联系。
如图12所示,根据各种实施方式,控制单元300可包括处理器306和一个或多个存储单元308。通过执行存储在存储器308中的指令代码,处理器306可基于从各种端部执行器传感器和其它传感器(例如运转马达传感器110、冲程结束传感器130和冲程开始传感器142)接收的输入信号控制器械10的各种部件,诸如马达65或者用户显示器(未显示)。在器械10的外科使用过程中,控制单元300可由电池64供电。在控制单元300不具有与传感器和/或马达的直接有线连接的实施方式中,控制单元300可包括感应元件302(例如线圈或者天线),用于从各种传感器/马达等发送和接收无线信号。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。输出信号可经由编码器316、调制器318和感应元件302发送。各种实施方式可包括用于接收和发送的单独的感应元件(未显示)。
根据各种实施方式,控制单元300可以为单个元件,诸如微控制器、系统集成芯片(SoC)或者封装系统(SIP)。作为替代方式,控制单元300可以为两个或多个分离式部件。如图11中所示,控制单元300可被容纳在器械10的手柄6中,并且用于器械10的一个或多个传感器可定位在端部执行器12中。在控制单元300和传感器368无线通信的实施方式中,控制单元300的感应元件302可经一根或多根导线(例如322)和/或次级感应元件(例如线圈320和324)与转发器感应。可对次级感应元件320、324进行设置,以避免导线穿过关节接头诸如旋转接头29、枢轴14等。
图13是端部执行器12的视图,该端部执行器12包括保持或者嵌入在钉仓3 4中位于通道2 2的远端处的传感器368。传感器368可通过合适的粘接材料诸如环氧树脂与钉仓34连接。在该实施方式中,传感器368包括磁阻抗传感器。钉砧24包括位于其远端并且一般朝向转发器368的永磁体369。在该示例性实施方式中钉仓34还包括与滑块33连接的永磁体370。这允许传感器368对端部执行器12的打开/关闭(由于当钉砧24打开和关闭时永磁体370运动得更远离或更接近转发器)以及缝合/切割操作的完成进行检测(由于当滑块33横过通道22时永磁体370向着转发器368的运动作为切割操作的一部分)。应当理解,各种其它传感器和/或传感器类型可被包括在端部执行器12和/或钉仓34包括例如所示的射频识别(RFID)传感器371中。
图13还显示了钉仓34的缝钉380和缝钉驱动器382。如前面解释的那样,根据各种实施方式,当滑块33横过通道22时,滑块33驱动缝钉驱动器382,缝钉驱动器将缝钉380驱动到保持在端部执行器12中的被切割组织中,从而使缝钉380抵靠钉砧24成形。如上说明的那样,这样的外科切割和紧固器械仅仅是其中本发明可有利地被采用的一种类型的外科器械。本发明的各种实施方式可在任何类型的具有一个或多个传感器的外科器械中使用。
在上述实施方式中,电池64或者其它合适的动力源为器械10的击发操作提供动力(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结合入本申请的专利申请‘573中有描述。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的方面的装置类型的例子。例如,器械10可包括由电池64供电并由控制单元300控制的用户显示器(诸如LCD或者LED显示器)。来自端部执行器12中的转发器368的数据可显示在这样的显示器上。
通常,外科器械诸如器械10在使用之前被清洁并灭菌。在一种灭菌技术中,器械10被放置在闭合和密封包装件280中,诸如塑料和/或TYVEK容器或者袋中,如图14和15所示。包装件280和器械然后被放置在可穿透包装件的辐射场中,诸如伽马射线、X射线或者高能电子。辐射杀死器械10上和包装件280中的细菌。经过灭菌的器械10然后可被储存在无菌包装件280中。密封的无菌包装件280保持器械10无菌直到其在医疗场合或者一些其它使用环境中被打开。作为辐射的替代,可使用其它方式对器械10进行灭菌,诸如环氧乙烷或者蒸汽。器械10可以以灭菌或者未灭菌状态提供给客户。当器械10以未灭菌状态提供时,客户可自行对器械10进行灭菌,或者将其外包给承包人。
图16显示了根据各种实施方式的器械10和包装件280的视图,包装件280也包括辅助动力源402。辅助动力源402可以经由连接件404和电路元件(未显示)与器械10(例如电池64)电连接。辅助动力源402可提供动力源以便为器械的动力源充电和/或重新充电。辅助动力源402可以是任何种类的电池或者其它合适动力源。例如,辅助动力源可包括可充电电池,诸如锂离子或者镍金属氢化物电池、不可充电电池诸如锌/碳、锌/碱/二氧化锰、锂/二氧化锰、锌/氧化银,、锂/二硫化铁等。
电路元件可调节从辅助动力源402输送到器械10的动力,以保证当器械10为使用而准备就绪时器械10的电池64或者其它动力源具有适当的电量。从物理上讲,电路元件可被定位在任何合适的位置,例如作为在包装件280中的、在辅助动力源402中的、器械等中的独立物品。连接件404可以是任何合适种类的连接件,例如包括直接有线连接、感应连接等。在感应连接中,连接件404可包括彼此非常靠近的感应元件。在第一感应元件中的电流可在第二感应元件中感应出相应电流,从而将电力传输通过连接件404。
图17显示了经由电路元件410与器械动力源406(例如电池64)连接的辅助动力源402的示例性示意图。辅助动力源402可根据任何合适的方法或者充电方案为器械动力源406充电。例如,电路元件410可包括动力源402、406之间的直接连接(例如感应或者有线)。当其电量消耗时,例如当器械10被闲置时,辅助动力源402可提供充电电流为器械动力源406充电。而且,例如辅助动力源402可基于动力源器械的当前状态提供充电电流。如图18所示,电路元件410可包括一个或多个开关412或电阻器(未显示)以监控器械动力源406上的电量并且当动力源406的电量到达预定阈值时从辅助动力源402提供电流。由辅助动力源402提供的电流还可以以各种其它方式进行调节,包括例如通过如图19所示的微处理器414和交换网络416。处理器414的功能由上述处理器306执行,或者通过器械10的任何其它控制系统执行。
根据各种实施方式,当器械10为使用而准备就绪时,辅助动力源402可相当迅速地为器械动力源406充电。例如,参见图18,当器械10和包装件280处于闲置状态时,开关412可保持在断开位置。因此,器械动力源406上的电量允许递降。当器械10准备就绪时,开关412闭合,允许辅助动力源402为动力源406提供充电电流,在使用之前为动力源406充电。例如,开关412可被构造成当包装件280打开时自动闭合。在各种实施方式中,开关可包括凸片405,如图16所示。凸片405可与包装件280的一部分连接并被构造成当打开包装件280时闭合开关412。而且,例如,临床医生可在使用或者即将使用器械10时拉动凸片405,从而闭合开关412并引起动力源406充电。
如上所述,一些端部执行器钉仓34可具有传感器或者需要动力源的其它电子部件。例如,图3显示了具有动力源456的钉仓34。动力源456可以是适于操作处于钉仓和/或端部执行器12中的电子设备的任何动力源。例如,动力源456可包括电容器、电池等。动力源456能以任何合适的位置(包括例如如图20所示在远尖端处以及如图21所示作为滑块33的一部分)定位在钉仓34中。
端部执行器钉仓34可根据上述方法存储和灭菌。例如,图20示出了封装在无菌包装件450中的钉仓34的视图。如图所示,包装件450还包括辅助动力源452。辅助动力源可为钉仓动力源456供电。与动力源402类似,动力源452可助于为钉仓34的动力源456充电或者再次充电,从而延长钉仓34的闲置寿命。辅助动力源452可经由连接件454和类似于上述电路元件的电路元件(未显示)与钉仓34连接。辅助动力源452、电路元件和钉仓动力源可被连接并可根据任何合适的有线或无线(例如感应)方法为动力源456充电,所述方法包括例如以上参照图17、18和19讨论的那些方法。
根据各种实施方式,钉仓动力源456可具有小的蓄电量。因此,可能需要防止该电量的非必要使用。例如,钉仓动力源456可与其负载电隔离,直到钉仓34为使用而准备就绪。钉仓34可包括当钉仓34被安装在端部执行器12中时闭合的断路开关或者其它电路元件。当断路开关闭合时,动力源456可与其负载连接(例如任何传感器或者处于钉仓34中的其它被供电电子设备)。
断路开关可以以任何合适的方式执行。例如,如图3所示,钉仓34可包括凹槽401,当钉仓34紧固在通道22中时该凹槽401由通道22中相应的突起(未示出)支承。开关元件可设置在这些凹槽401中。当钉仓34被安装在通道22中时,突起可被容纳在凹槽401中,从而闭合断路开关并将动力源456与其负载连接。图21显示了断路开关的其它实施方式。如图所示,断路开关可包括定位在钉仓34的侧壁上的一对电触头462。当钉仓34连接在通道22中(见图3)时,触头462通过通道22的导电侧壁短路,将开关闭合并将动力源456与其负载连接。
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,而是能在包括远程传感器转发器的任何类型的外科器械中使用。例如,它可以是非切割型外科器械、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、激光的能量装置等。另外,本发明例如可以是腹腔镜器械。
在本文中公开的装置可以单次使用后抛弃,或者可以多次使用。但是在这两种情况下,装置可被修复以便在至少使用一次后再次使用。修复可包括装置拆卸步骤的任何组合,接着清洗或者替换特定部件,随后组装。尤其是装置可被拆卸,并且装置的任意数量的特定件或部分可以任何组合选择性地替换或者去除。在清洁和/或替换特定部件后,为了随后的使用装置可在修复车间重新组装,或者在外科手术之前由外科团队即将进行外科程序之前重新组装。本领域技术人员将会理解,可利用用于拆卸、清洁/替换和重新组装的各种技术来修复装置,所述技术的使用和所产生的修复好的装置都在本发明的范围内。
虽然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,但是可执行这些实施方式的任何修改和变化。例如,不同类型的端部执行器可被采用。而且,被公开用于一些部件的材料也可使用其它材料。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。
申明通过引用结合入本文的任何专利、出版物或者其它公开材料(全部或部分)仅限于所结合的材料不与在该公开文本中阐明的已有定义、表述或者其它公开材料相冲突。如此以来,并且在必要时,在本文中明确阐明的公开内容取代任何通过引用结合入本文的冲突材料。申明通过引用结合入本文的但与现有定义、表述或者其它公开材料相冲突的任何材料或者其部分仅以不引起所结合的材料与已有公开材料之间存在冲突的程度结合。
Claims (5)
1.一种组件,包括:
包装件;
位于所述包装件中的外科器械部件;
位于所述包装件中的动力源,其中所述动力源能够与所述外科器械部件电连接;
位于所述包装件中的辅助动力源;和
与所述动力源和辅助动力源电连接的开关,其中所述开关包括与所述包装件的一部分连接的凸片,所述凸片的连接方式使得在所述包装件封闭时使所述开关处于打开位置,并且在所述包装件打开时使所述开关自动闭合。
2.根据权利要求1所述的组件,其中所述包装件被灭菌。
3.根据权利要求1所述的组件,其中所述动力源是电池组。
4.根据权利要求3所述的组件,其中所述电池组包括至少一个电池,所述至少一个电池选自包括锂离子电池和镍金属氢化物电池的组。
5.根据权利要求1所述的组件,其中所述动力源是电容器。
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- 2008-01-09 EP EP08250099.2A patent/EP1943976B1/en not_active Not-in-force
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- 2008-01-09 EP EP11160040.9A patent/EP2353538B1/en not_active Not-in-force
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EP2353538A3 (en) | 2013-03-27 |
EP1943976B1 (en) | 2014-04-30 |
EP2353538A2 (en) | 2011-08-10 |
CN101234032A (zh) | 2008-08-06 |
JP2008259815A (ja) | 2008-10-30 |
PL2353538T3 (pl) | 2018-06-29 |
HK1118435A1 (zh) | 2009-02-13 |
PL1943976T3 (pl) | 2014-09-30 |
US7900805B2 (en) | 2011-03-08 |
JP5259196B2 (ja) | 2013-08-07 |
EP1943976A2 (en) | 2008-07-16 |
EP2353538B1 (en) | 2018-01-03 |
EP1943976A3 (en) | 2008-08-06 |
US20080167644A1 (en) | 2008-07-10 |
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