CN101224118A - 联锁装置及包括联锁装置的外科器械 - Google Patents

联锁装置及包括联锁装置的外科器械 Download PDF

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CN101224118A
CN101224118A CNA2008100026190A CN200810002619A CN101224118A CN 101224118 A CN101224118 A CN 101224118A CN A2008100026190 A CNA2008100026190 A CN A2008100026190A CN 200810002619 A CN200810002619 A CN 200810002619A CN 101224118 A CN101224118 A CN 101224118A
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cutting device
motor
nail bin
end effector
passage
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CN101224118B (zh
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F·E·谢尔顿四世
J·R·乔达诺
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477Coupling
    • A61B2017/00482Coupling with a code
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681Aspects not otherwise provided for
    • A61B2017/00734Aspects not otherwise provided for battery operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07278Stapler heads characterised by its sled or its staple holder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2051Electromagnetic tracking systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0807Indication means
    • A61B2090/0811Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0814Preventing re-use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361Image-producing devices, e.g. surgical cameras

Abstract

本发明涉及一种联锁装置及包括联锁装置的外科器械。所述器械包括端部执行器,该端部执行器包括用于切割物体的可动切割器械和连接到端部执行器的马达。所述马达响应于通过的电流而致动所述切割器械,使该切割器械在最近侧位置和最远侧位置之间运动。所述器械还包括连接到端部执行器和马达上的联锁装置,用于基于通过马达的电流来防止切割器械的致动。

Description

联锁装置及包括联锁装置的外科器械
本申请涉及如下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等人的题为“在控制单元和传感器转发器之间能够无线通信的外科器械”(SURGICAL INSTRUMENT WITH WIRELESSCOMMUNICATION BETWEEN CONTROL UNIT AND SENSOR TRANSPONDERS)的美国专利申请(律师档案号060338/END5923USNP);
(2)J.Giordano等人的题为“在控制单元和远程传感器之间能够无线通信的外科器械”(SURGICAL INSTRUMENT WITH WIRELESSCOMMUNICATION BETWEEN CONTROL UNIT AND REMOTE SENSOR)的美国专利申请(律师档案号060339/END5924USNP);
(3)J.Giordano等人的题为“在控制单元和端部执行器之间具有通信元件的外科器械”(SURGICAL INSTRUMENT WITH ELEMENTS TOCOMMUNICATE BETWEEN CONTROL UNIT AND END EFFECTOR)的美国专利申请(律师档案号060340/END5925USNP);
(4)F.Shelton等人的题为“对仓重新用在外科器械中的防止”(PREVENTION OF CARTRIDGE REUSE IN A SURGICAL INSTRUMENT)的美国专利申请(律师档案号060341/END5926USNP);
(5)J.Swayze等人的题为“外科器械的消毒后程序”(POST-STERILIZATION PROGRAMMING OF SURGICAL INSTRUMENTS)的美国专利申请(律师档案号060342/END5924USNP);和
(6)F.Shelton等人的题为“具有增强的电池性能的外科器械”(SURGICAL INSTRUMENT WITH ENHANCED BATTERY PERFORMANCE)的美国专利申请(律师档案号060347/END5931USNP)。
技术领域
本发明通过各种实施方式从总体上涉及外科缝合和切割器械,所述外科缝合和切割器械的结构和设置能够用于将成排缝钉从钉仓施放到组织上,同时切割所施放的缝钉排之间的组织。更具体地说,本发明涉及用于马达驱动的外科缝合和切割器械的联锁装置,用来在未安装钉仓或者在钉仓已安装但缝钉被用尽时防止组织的切割。
背景技术
与传统的开放式外科器械相比,内窥镜外科器械通常更受青睐,这是因为较小的切口易于减少术后恢复时间和并发症。因此,各种内窥镜外科器械已经有了显著的发展,这些器械适于通过套管针的套管将远侧端部执行器精确放置在所需的手术部位。这些远侧端部执行器(例如,内切割器、抓钳、切割器、缝合器、夹施放器、进入装置、药物/基因治疗输送装置、以及使用超声波、RF、或激光等的能量装置)以各种方式与组织接合,达到诊断或治疗的效果。
已知的外科缝合器包括端部执行器,该端部执行器在组织中形成纵向切口的同时在切口的相对两侧上施加多排缝钉。所述端部执行器包括一对相配合的钳口构件,如果器械用于内窥镜或者腹腔镜应用,这对钳口构件能够穿过套管通道。钳口构件中的一个容纳具有至少两个横向间隔的缝钉排的钉仓。另一个钳口构件限定了具有缝钉成形凹口的钉砧,所述凹口与钉仓中的缝钉排对准。该器械包括多个往复运动的楔形件,这些楔形件在被向远侧驱动时穿过钉仓中的开口并与支撑缝钉的驱动器接合,向着钉砧击发缝钉。
有利的是,端部执行器可以被设计成能够与外科缝合器重复使用。例如,一个患者可能需要一系列切割和缝合操作。针对每次操作更换整个端部执行器可能不那么经济,特别是该端部执行器被制得为了重复操作而具有一定强度和可靠性时。为此,钉仓通常被构造成一次性的,并且在外科缝合器的每次操作之前被装入端部执行器。
在Knodel等人的名称为“SURGICAL STAPLER INSTRUMENT”的美国专利No.5,465,895中描述了适于内窥镜应用的外科缝合器的一个例子,其中公开了具有不同的闭合和击发动作的内切割器。由此,操作者能够将钳口构件闭合在组织上,以在击发前定位组织。一旦操作者确认钳口构件正确夹持组织,操作者可以以单击发行程或者多击发行程(取决于该装置)击发该外科缝合器。击发该外科缝合器导致切割和缝合组织。同时切割和缝合避免了采用分别只进行切割和缝合的不同外科工具顺序执行这种动作可能导致的并发症。
能够在击发之前闭合在组织上的一个具体的优点是,操作者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,对置的钳口可能被拉得彼此过近,尤其是在他们的远端挤紧,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,过量夹紧的组织可能导致束缚和不完全击发。
由于闭合钳口并且同时执行切割和缝合操作所需的致动力(即,击发力,或者FTF)可能很大,诸如如上所述的手动切割和缝合器械可能无法被不能产生所需FTF的操作者使用,这些操作者在其他情况中可能是合格的操作者。因此,已经开发了动力驱动的切割和缝合器械来减小击发力(FTF)。这种器械通常结合有马达或者其他致动机构,适合用来增强或者替换用于执行切割和缝合操作的操作者生成力。
尽管动力驱动的器械提供了多种优点,但是需要防止在一定条件下器械的无意中击发。例如,击发未安装钉仓的器械或者击发安装了钉仓但缝钉用尽(例如在先击发)的器械,这可能导致切割组织而未能同时缝合而使流血量最小。在这些情况下防止动力驱动的内切割器操作的联锁装置此前使用位于端部执行器中的电子传感器,用于确定未用尽的钉仓是否已经安装在端部执行器中。Swayze等人的发明名称为“ELECTRONIC INTERLOCKS AND SURGICALINSTRUMENT INCLUDING SAME”的美国专利申请No.11/343,439(其公开的内容通过引用结合入本文)公开了电子传感器的使用,该电子传感器设置在端部执行器内,用于确定未用尽的钉仓是否已经安装。所述传感器可包括与马达或其他电动致动机构串联的开关,从而在未安装钉仓或者钉仓被安装但用尽时阻断产生致动力所须的电流。尽管这种电子联锁装置很有效,但是将传感器设置在端部执行器中并且在传感器和马达电子器件(通常容纳在器械手柄中)之间布置电线增加了器械的复杂性和成本。
尽管已知位于端部执行器中用于防止无意中击发的机械联锁装置的使用,并能够避免与端部执行器的电子器件相关的复杂性,但是这种机构此前局限于手动内切割器。特别是,这种机构的机械强度不能抵抗电动致动机构产生的击发力。另外,即使机械联锁装置能够承受击发力,最终的物理应力可能传递到器械的其他组成元件,并且导致难以接受的磨损或损坏。
因此,非常需要用于动力致动的切割和缝合器械的联锁装置,其能够防止无意中击发(例如,切割但不缝合),同时避免配备传感器的端部执行器的复杂性和否则可能由于使用传统的机械联锁装置而导致的有害的物理应力。
发明内容
本申请公开了根据各种实施方式的外科切割和缝合器械。所述切割和缝合器械包括端部执行器,该端部执行器包括用于切割物体的可动切割器械和用于响应于通过的电流而致动所述切割器械的马达。所述切割器械的致动导致该切割器械在最近侧位置和最远侧位置之间运动。所述切割和缝合器械还包括连接到端部执行器和马达上的联锁装置,用于基于通过马达的电流防止切割器械的致动。
本申请还公开了一种防止外科器械的操作的方法。所述外科器械被构造成可动地容纳可用钉仓,并且包括可动切割器械和用于响应于通过的电流而致动所述切割器械的马达。所述方法包括在器械中没有未耗尽钉仓时以机械方式阻止马达对切割器械的致动,检测由于切割器械的致动被阻止而导致的通过马达的电流,并且根据所检测的电流中断通过马达的电流。
具体而言,本发明公开了如下内容:
(1).一种外科器械,包括:
具有用于切割物体的可动切割器械的端部执行器;
连接到所述端部执行器的马达,用于响应于通过其的电流来致动所述切割器械,其中所述切割器械的致动使该切割器械在最近侧位置和最远侧位置之间运动;以及
连接到所述端部执行器和所述马达上的联锁装置,用于基于通过所述马达的电流防止所述切割器械的致动。
(2).如第(1)项所述的器械,其中,所述端部执行器还包括:
纵向延伸通道,所述通道具有近端和远端;
以可枢转的方式连接到所述通道的钉砧,其中所述物体位于所述钉砧和所述通道之间;
以可拆卸的方式置于所述通道中的钉仓,所述钉仓具有近端和远端;
形成于所述钉仓和所述通道之间的击发驱动槽,当致动所述切割器械时至少部分所述切割器械经过所述击发驱动槽;以及
设置于所述钉仓中的滑块,其中当致动所述切割器械时所述滑块由所述切割器械接合,并被从位于所述钉仓近端的未击发位置纵向驱动穿过该钉仓到达位于所述钉仓远端的击发位置。
(3).如第(2)项所述的器械,其中,所述联锁装置包括:
用于防止所述切割器械的致动的阻止机构,其中在所述滑块未处于未击发位置时启动所述阻止机构;以及
用于感测通过所述马达的电流并根据所感测的电流来中断通过所述马达的电流的闭锁电路。
(4).如第(3)项所述的器械,其中,所述闭锁电路还用于根据所述切割器械的位置来中断通过所述马达的电流。
(5).如第(3)项所述的器械,其中,当所述阻止机构阻止所述切割器械纵向前进通过所述通道时,通过所述马达的电流增大。
(6).如第(3)项所述的器械,其中,所述阻止机构包括至少一个设置在所述通道中的弹簧夹。
(7).如第(3)项所述的器械,其中,所述阻止机构包括至少一个弹性地连接到所述通道的倾斜钩。
(8).如第(3)项所述的器械,其中,所述阻止机构与所述钉仓一体形成,并且包括至少一个向近侧凸出的构件,其中所述至少一个向近侧凸出的构件能够在所述击发驱动槽和所述钉仓中的凹槽之间运动。
(9).如第(3)项所述的器械,其中,所述闭锁电路包括用于生成代表所感测电流的第一信号的电流传感器。
(10).如第(9)项所述的器械,其中,所述闭锁电路还包括用于将所述第一信号与预定阈值信号进行比较的电流检测模块。
(11).如第(10)项所述的器械,其中,所述电流检测模块包括微处理器。
(12).如第(10)项所述的器械,其中,所述闭锁电路还包括用于确定所述切割器械的位置的位置传感器。
(13).如第(12)项所述的器械,其中,所述闭锁电路还包括与所述马达串联连接的开关,所述开关是可控的,其能够根据所述切割器械的位置以及所述第一信号与所述预定阈值信号的比较来中断通过所述马达的电流。
(14).如第(13)项所述的器械,其中,所述开关能够被控制成在所述切割器械的位置处于其最近侧位置的预定距离内时以及在所述第一信号超过所述预定阈值信号时中断通过所述马达的电流。
(15).一种用于防止外科器械操作的方法,所述外科器械被构造成用于以可拆卸的方式接收可用钉仓,并且所述外科器械包括可动切割器械和响应于通过的电流而致动所述切割器械的马达,所述方法包括:
在所述器械中没有未用尽的钉仓时以机械方式阻止所述马达对所述切割器械的致动;
检测由于所述切割器械的致动被阻止而导致的通过所述马达的电流;以及
根据所检测的电流中断通过所述马达的电流
(16).如第(15)项所述的方法,其中,检测通过所述马达的电流包括:
感测马达电流;
生成代表所感测的马达电流的信号;以及
将所生成的信号与阈值信号进行比较。
(17).如第(16)项所述的方法,其中,中断通过所述马达的电流包括在所生成的信号超过所述阈值信号时中断所述电流。
(18).如第(17)项所述的方法,其中,中断通过所述马达的电流还包括根据所述切割器械的位置中断所述电流。
(19).一种处理外科器械的方法,包括:
获取所述外科器械,其中所述外科器械包括:
具有用于切割物体的可动切割器械的端部执行器;
连接到所述端部执行器的马达,用于响应于通过其的电流来致动所述切割器械,其中所述切割器械的致动使该切割器械在最近侧位置和最远侧位置之间运动;以及
连接到所述端部执行器和所述马达上的联锁装置,用于基于通过所述马达的电流来防止所述切割器械的致动;
对所述外科器械进行消毒;以及
将所述外科器械存储在无菌容器中。
附图说明
结合附图以示例方式说明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3A是根据本发明的各种实施方式的端部执行器的分解图;
图3B是图3A的切割器械的透视图;
图4和5是根据本发明的各种实施方式的器械的端部执行器和轴的分解图;
图6是根据本发明的各种实施方式的端部执行器的侧视图;
图7是根据本发明的各种实施方式的器械的手柄的分解图;
图8和9是根据本发明的各种实施方式的手柄的部分透视图;
图10是根据本发明的各种实施方式的手柄的侧视图;
图11至12分别示出了根据本发明的各种实施方式使用的比例传感器;
图13至27分别示出了根据本发明的各种实施方式的机械阻止机构及其顺序的操作;
图28至29示出了用于根据本发明的各种实施方式的器械的电路的示意图;
图30是根据本发明的各种实施方式通过图29中的微控制器执行的过程的流程图;
图31是通过根据本发明的各种实施方式的联锁装置执行的过程的流程图。
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。所示出的实施例是内镜器械,总体而言,此处示出的器械10的实施例是内镜外科切割和紧固器械。但是,应当理解的是,根据本发明的其他实施方式,所述器械可以是非内镜外科切割和紧固器械,诸如腹腔镜器械。
图1和2示出的外科器械10包括手柄12、轴14和在关节枢轴18处可枢转地连接到轴14的关节运动端部执行器16。关节运动控制器20可靠近手柄12设置,以便使端部执行器16绕关节枢轴18转动。在所示出的实施方式中,端部执行器16被构造成用作内切割器,用于夹钳、切割和缝合组织,但是在其他实施方式中,可以使用不同类型的端部执行器,诸如用于其他类型的外科器械的端部执行器,例如抓钳、切割器、缝合器、夹施放器、进入装置、药物/基因治疗装置、以及超声、RF或激光装置等。
器械10的手柄12可包括闭合扳机22和用于致动端部执行器16的击发扳机24。应当理解,具有用于不同外科任务的端部执行器的器械可具有不同数量或者类型的扳机或用于操作端部执行器16的其他适合的控制器。所示出的端部执行器16优选通过细长轴14与手柄12隔开。在一种实施方式中,器械10的操作者可通过使用关节运动控制器20使端部执行器16相对于轴14进行关节运动,所述关节运动控制器20如在Hueil等人的名称为“SURGICAL INSTRUMENTHAVING AN ARTICULATING END EFFECTOR”的未决美国专利申请No.11/329,020中更详细地描述,该文献通过参考结合入本文。
在本实施例中,除了其他的,端部执行器16包括缝钉通道26和可枢转移动的钳口构件诸如钉砧28,他们保持隔开,确保夹在端部执行器16中的组织的有效缝合和切割。手柄12包括手枪式握把30,由操作者朝着该手枪式握把30枢转地拉动闭合扳机22使得端部执行器16的钉砧28朝着缝钉通道26夹钳或者闭合,由此夹钳定位在钉砧28和通道26之间的组织。击发扳机24位于闭合扳机22的更远侧。一旦闭合扳机22如下面将更详细描述的那样锁定在闭合位置,击发扳机24可朝着手枪式握把30略微转动,从而可由操作者用一只手触及。然后操作者可朝着手枪式握把30枢转地拉动击发扳机24,以便缝合和切割夹在端部执行器16中的组织。在其他实施方式中,除了钉砧28外可使用其它类型的钳口构件,诸如例如对置的钳口等。
应当理解,此处使用的术语“近侧”和“远侧”是相对于抓持器械10的手柄12的操作者而言。因此,端部执行器16相对于更近侧的手柄12而言位于远侧。还应当理解,为了方便和清楚,此处使用的空间术语诸如“垂直”和“水平”是相对于附图而言的。但是,可在多种方位使用外科器械,并且这些术语并不是限制性的和绝对的。
可首先致动闭合扳机22。一旦操作者对端部执行器16的定位满意,操作者可将闭合扳机22向回拉动到其靠近手枪式握把30的完全闭合的锁定位置。然后可致动击发扳机24。如下面将更完整地描述地,当操作者移开压力时,击发扳机24返回到张开位置(如图1和2所示)。位于手柄12上的释放按钮32在被压下时可松开锁定的闭合扳机22。使用释放按钮32锁定和解锁闭合扳机22的各种构造在Shelton,IV等人的名称为“MOTOR-DRIVEN SURGICAL CUTTINGAND FASTENING INSTRUMENT WITH LOADING FORCE FEEDBACK”的未决美国专利申请No.11/343,573中有说明,该文献通过引用结合入本文。
图3A是根据各种实施方式的端部执行器16的分解图。如所阐述的实施方式所示,除了前面提及的缝钉通道26和钉砧28,端部执行器16可包括切割器械34、滑块36、可拆卸地置于(例如安装)通道26中的钉仓38、以及螺纹轴40。图3B是图3A的切割器械的透视图。
钉砧28可在连接到通道26的近端上的枢轴点42处可枢转地张开和闭合。钉砧28还可包括位于其近端的凸片44,用于插入机械闭合系统(在下面说明)的组成元件中,以便张开和闭合钉砧28。当致动闭合扳机22时,也就是由器械10的操作者向内拉动闭合扳机22时,钉砧28可绕着枢轴点42枢转到夹钳或闭合位置。如果对端部执行器16的夹钳满意,操作者可致动击发扳机24,如在下面更详细说明的,击发扳机24使切割器械34沿着通道26纵向地运动。
如图所示,切割器械34包括上导销46,这些上导销46进入钉砧28中的钉砧槽48,以便在切割和缝钉成形过程中确认和辅助将钉砧28保持在闭合状态。通过通道26中的纵向开口54的引导使切割器械34的中间销50沿着通道26的顶面滑动、同时使其底脚52沿着通道26的底面相对地滑动,以通过切割器械34进一步保持通道26和钉砧28之间的间隔。位于上导销46和中间销50之间的朝向远侧的切割表面56切割夹钳的组织,同时,朝向远侧的表面58通过将滑块36逐渐地从未击发位置驱动到击发位置而致动钉仓38。钉仓38的致动使得缝钉驱动器60进行向上凸起运动,从而将缝钉62从形成于钉仓38中的向上开口的缝钉孔64驱动出来。随后缝钉62抵靠钉砧28的钉成形下表面66成形。钉仓托架68从底部包围钉仓38的其他组成元件,以便将他们保持就位。钉仓托架68包括向后开口槽70,其位于通道26中的纵向开口54上方。钉仓38的下表面和通道26的上表面形成击发驱动槽200(图6),在切割器械34的远侧运动和近侧运动过程中中间销50经过该击发驱动槽200。滑块36可以是钉仓38的一体组成元件,从而在切割操作之后缩回切割器械34时该滑块36不会缩回。在Shelton,IV等人的名称为“SURGICALSTAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM”的美国专利No.6,978,921中更详细地公开了这种两行程切割和紧固器械,该文献通过引用结合入本文。
应当理解,尽管此处描述的器械10的实施方式采用钉合被切割的组织的端部执行器16,但是在其他实施方式中可以使用用于紧固或密封被切割组织的不同的技术。例如,也可以使用采用RF能量或者粘合剂的端部执行器。Yates等人的发明名称为“ELECTROSURGICALHEMOSTATIC DEVICE”的美国专利No.5,709,680以及Yates等人的名称为“ELECTROSURGICAL HEMOSTATIC DEVICE WITH RECESSED AND/OROFFSET ELECTRODES”的美国专利No.5,688,270公开了使用RF能量紧固被切割的组织的切割器械,这两篇文献通过引用被结合入本文。Morgan等人的名称为“SURGICAL STAPLING INSTRUMENTSSTRUCTURED FOR DELIVERY OF MEDICAL AGENTS”的美国专利申请No.11/267,811和Shelton IV等人的名称为“SURGICAL STAPLINGINSTRUMENTS STRUCTURED FOR PUMP-ASSISTED DELIVERY OF MEDICALAGENTS”的美国专利申请No.11/267,383公开了使用粘合剂紧固被切割的组织的切割器械,这两篇文献通过引用被结合入本文。因此,尽管此处的说明提及切割/缝合操作等,但是应当认识到,这是示例性实施方式,并不意味着限制。也可使用其他组织紧固技术。
图4和5是根据各种实施方式的端部执行器16和轴14的分解图,图6是侧视图。如所阐述的实施方式所示,轴14可包括通过枢转连接件76可枢转地连接的近侧闭合管72和远侧闭合管74。远侧闭合管74包括开口78,钉砧28上的凸片44插入开口78,以便张开和闭合钉砧28,如下面更详细说明的。近侧脊管79设置在闭合管72和74内。主旋转(或近侧)驱动轴80设置在近侧脊管79内,借助锥齿轮组件84与次(或远侧)驱动轴82连接。次驱动轴82连接到驱动齿轮86,该驱动齿轮86与螺纹轴40的近侧驱动齿轮88接合。竖直的锥齿轮84b位于近侧脊管79的远端的开口90中,并在其中枢转。远侧脊管92可用于包围次驱动轴82和驱动齿轮86、88。总体上,主驱动轴80、次驱动轴82和关节运动组件(例如锥齿轮组件84a-c)在此处有时被称作“主驱动轴组件”。
位于缝钉通道26的远端处的支撑件(轴承)94(图6)接收螺纹轴40,允许螺纹轴40相对于通道26自由旋转。螺纹轴40可与切割器械34的螺纹开口(未示出)接界,螺纹轴40的旋转使切割器械34向远侧或近侧(取决于旋转的方向)移动通过缝钉通道26。由此,当通过击发扳机24的致动而使主驱动轴80旋转时(如下面将更详细说明的),锥齿轮组件84a-c使次驱动轴82旋转,由于驱动齿轮86、88的接合,次驱动轴82又使得螺纹轴40旋转,这又使得切割器械34沿着通道26纵向运动,从而切割夹钳在端部执行器16内的任何组织。滑块36可由例如塑料制成,并且可具有倾斜的远侧表面。随着滑块36经过通道26,倾斜的远侧表面向上顶起缝钉驱动器60,该缝钉驱动器60又推起或驱动钉仓38中的缝钉62穿过夹紧的组织并抵靠在钉砧28的钉成形下表面66上,由此缝合被切割的组织。当缩回切割器械34时,切割器械34和滑块36脱离接合,由此将滑块36留在通道26的远端。
图7至10示出了马达驱动的内切割器、尤其是其手柄12的一种示例性实施方式,手柄12提供了在端部执行器16中,切割器械34展开和加载力的操作者反馈。另外,在缩回击发扳机24时该实施方式可使用操作者提供的能量,以驱动该装置(所谓的“动力辅助”模式)。如所阐述的实施方式所示,手柄12包括外部下侧件96、98和外部上侧件100、102,它们装配在一起,在总体上形成手柄12的外部形状。电池104可被设置在手柄12的手枪式握把30部分中。电池104可根据任何合适的结构或化学性质构造,包括例如锂离子化学电池诸如LiCoO2或LiNiO2、镍金属氢化物化学电池等。电池104为设置在手柄12的手枪式握把30部分的上部的马达106供能。根据各种实施方式,马达106可以是DC刷式驱动马达,具有大约5000至100,000RPM的最大转速。马达106可驱动90度锥齿轮组件108,该锥齿轮组件108包括第一锥齿轮110和第二锥齿轮112。锥齿轮组件108可驱动行星齿轮组件114。行星齿轮组件114可包括连接到驱动轴118的小齿轮116。小齿轮116可驱动配合环形齿轮120,该环形齿轮120通过驱动轴124驱动斜齿轮鼓122。环126可旋到斜齿轮鼓122上。由此,当马达106旋转时,通过介于其间的锥齿轮组件108、行星齿轮组件114和环形齿轮120使环126沿着斜齿轮鼓122行进。
手柄12还可包括与击发扳机24相关联的马达运行传感器128,以便检测操作者向着手柄12的手枪式握把30部分向内拉动(或“闭合”)击发扳机24的时刻,由此通过端部执行器16致动切割/缝合操作。传感器128可以是比例传感器诸如例如变阻器或者可变电阻器。当向内拉动击发扳机24时,传感器128检测到运动并发出表明待输送到马达106的电压(或能量)的电信号。当传感器128是可变电阻器等时,马达106的旋转可与击发扳机24的运动量大致成比例。也就是,如果操作者仅仅拉动或略微闭合击发扳机24,马达106的转速相对较低。当将击发扳机2 4完全向内拉(或处于完全闭合位置)时,马达106的转速为最大。换句话说,操作者越是用力地拉动击发扳机24,施加到马达106的电压越大,从而导致转速更高。在另一种实施方式中,例如,微处理器(例如图29的微处理器250)可根据来自传感器128的输入而输出PWM控制信号到马达106,以便控制马达106。
手柄12可包括邻近击发扳机24的上部的中间手柄件130。手柄12还可包括连接到位于中间手柄件130上的柱和击发扳机24之间的偏压弹簧132。偏压弹簧132可将击发扳机24偏压到其完全张开位置。这样,当操作者松开击发扳机24时,偏压弹簧132将把击发扳机24拉到其张开位置,由此去除传感器128的致动,由此停止马达106的旋转。而且,借助于该偏压弹簧132,无论何时操作者闭合击发扳机24,操作者将会体验到对闭合操作的阻力,由此为操作者提供马达106施加的旋转量多少的反馈。另外,操作者可以停止缩回击发扳机24,由此去掉传感器128上的力,从而停止马达106。这样,操作者可停止端部执行器16的展开,由此为操作者提供切割/紧固操作的控制手段。
斜齿轮鼓122的远端包括驱动环形齿轮136的远侧驱动轴134,该环形齿轮136与小齿轮138啮合。小齿轮138连接到主驱动轴组件的主驱动轴80。这样,马达106的旋转导致主驱动轴组件旋转,这又导致端部执行器16的致动,如上所述。
旋到斜齿轮鼓122上的环126可包括柱140,该柱140置于带槽臂144的槽142中。带槽臂144在其相对端148处具有开口146,开口146容纳连接在手柄外部下侧件96、98之间的枢销150。枢销150还设置成穿过击发扳机24中的开口152和中间手柄件130中的开口154。
另外,手柄12还可包括反转马达(或行程结束)传感器156和停止马达(或行程开始)传感器158。在各种实施方式中,反转马达传感器156可以是位于斜齿轮鼓122的远端处的常断限制开关,使得旋在斜齿轮鼓122上的环126在其到达斜齿轮鼓122的远端时接触并接通反转马达传感器156。当反转马达传感器156接通时其向马达106发出信号,使马达106反向,由此在切割操作后缩回端部执行器16的切割器械34。
停止马达传感器158可以例如是常通限制开关。在各种实施方式中,其可以位于斜齿轮鼓122的近端,使得环126在到达斜齿轮鼓122的近端时断开开关158。
在操作过程中,当器械10的操作者向回拉动击发扳机24时,传感器128检测击发扳机24的使用,并向马达106发出信号,以使马达106以例如与操作者向回拉击发扳机24的用力程度成比例的速率向前旋转。马达106的向前旋转又导致位于行星齿轮组件114的远端处的环形齿轮120旋转,由此使得斜齿轮鼓122旋转,导致旋在斜齿轮鼓122上的环126沿着斜齿轮鼓122向远侧行进。斜齿轮鼓122的旋转还如上所述地驱动主驱动轴组件,主驱动轴组件又导致端部执行器16中的切割器械34的使用。也就是,使得切割器械34和滑块36纵向地经过通道26,由此切割夹钳在端部执行器16中的组织。而且,端部执行器16的缝合操作发生在使用缝合型端部执行器的实施方式中。
在完成端部执行器16的切割/缝合操作时,位于斜齿轮鼓122上的环126将达到斜齿轮鼓122的远端,由此启动反转马达传感器156,该反转马达传感器156向马达106发出信号,使马达106反转。这又导致切割器械34缩回,并导致位于斜齿轮鼓122上的环126回到斜齿轮鼓122的近端。
中间手柄件130包括后侧肩部160,该后侧肩部160与带槽臂144接合,如在图8和9中最清楚显示的。中间手柄件130还包括前向运动止动件162,其与击发扳机24接合。如上所述,带槽臂144的运动通过马达106的旋转控制。当带槽臂144随着环126从斜齿轮鼓122的近端行进到远端而逆时针方向旋转时,中间手柄件130将沿逆时针方向自由旋转。由此,当操作者向内拉动击发扳机24时,击发扳机24将与中间手柄件130的前向运动止动件162接合,从而使中间手柄件130逆时针方向旋转。但是,由于与带槽臂144接合的后侧肩部160,中间手柄件130将仅能逆时针方向旋转到带槽臂144允许的程度。这样,如果马达106由于某些原因停止旋转,带槽臂144将停止旋转,并且操作者将不能进一步向内拉动击发扳机24,因为中间手柄件130由于带槽臂144而无法自由地逆时针旋转。
图11和12示出了根据本发明的各种实施方式可用作马达运行传感器128的可调传感器的两种状态。传感器128可包括面部164、第一电极(A)166、第二电极(B)168、以及位于电极166和168之间的可压缩电介质材料170(例如EAP)。传感器128可定位成面部164在击发扳机24缩回时与之接触。由此,当击发扳机24缩回时,电介质材料170被压缩,如图12所示,使得电极166和168向一起靠近。因为电极166和168之间的距离“b”与电极166和168之间的阻抗直接相关,该距离越远,阻抗越大,该距离越近,阻抗越小。这样,由于击发扳机24的缩回导致的电介质材料170的压缩(在图12中以力“F”表示)量与电极166和168之间的阻抗成比例,这可用于马达106的比例控制。
在图7至10中还示出了通过缩回闭合扳机22来闭合(或夹紧)端部执行器16的钉砧28的示例性闭合系统的组成元件。在示出的实施方式中,闭合系统包括通过销174连接到闭合扳机22的轭形件172,销174插入穿过闭合扳机22和轭形件172二者中的对准的开口。闭合扳机2 2绕枢销176旋转,该枢销176插入穿过闭合扳机22中的另一个开口,其与销174插入穿过闭合扳机22的位置是偏离开的。因此,闭合扳机22的旋转导致闭合扳机22的上部(轭形件172通过销174连接到闭合扳机22的上部)逆时针旋转。轭形件172的远端通过销178连接到第一闭合支架180。第一闭合支架180连接到第二闭合支架182。闭合支架180、182一起形成一开口,近侧闭合管72的近端(见图4)置于并保持在该开口中,闭合支架180、182的纵向运动导致近侧闭合管72的纵向运动。器械10还包括设置在近侧闭合管72中的闭合杆184。闭合杆184可包括窗口186,位于手柄外部件之一(例如在所示出的实施方式中为外部下侧件96)上的柱188进入该窗口186,从而将闭合杆184固定地连接到手柄12上。这样,近侧闭合管72能够相对于闭合杆184纵向运动。闭合杆184还可包括远侧卡圈190,该卡圈190被装配入近侧脊管79的腔192中,并由帽194保持在其中(见图4)。
在操作过程中,当轭形件172由于闭合扳机22的缩回而旋转时,闭合支架180、182使近侧闭合管72向远侧运动(即,离开器械10的手柄12),这使得远侧闭合管74向远侧运动,钉砧28绕着枢销42旋转进入夹钳或闭合位置。当闭合扳机22从锁定位置解锁时,使近侧闭合管72向近侧滑动,这导致远侧闭合管74向近侧滑动,借助插入到远侧闭合管74的开口78中的凸片44,使得钉砧28绕着枢销42旋转进入张开或松开位置。这样,通过缩回和锁定闭合扳机22,操作者可夹钳位于钉砧28和通道26之间的组织,并且在切割/缝合操作之后通过使闭合扳机22从锁定位置解锁而松开组织。
根据各种实施方式,器械10可包括联锁装置,用于在钉仓38未安装在通道26、或者钉仓38安装在通道26中但是已用尽时防止器械10的操作。联锁装置的操作是双重的。首先,在通道26中没有未用尽的钉仓38时,联锁装置运行,以便响应于击发扳机24的致动而以机械方式阻止切割器械34穿过通道26向远侧运动。使用设置在手柄12中的合适的电子器件,联锁装置接下来可检测由于切割器械34不动而导致的通过马达106的电流增加,并且随后中断到马达106的电流。有利的是,联锁装置不需要位于端部执行器16中的电子传感器,由此简化了器械的设计。而且,由于在马达电流中产生检测到的增加所需的机械阻止力的大小和持续时间远小于如果仅使用传统机械联锁装置将施加的力的大小和持续时间,所以器械组成元件的物理应力被减小。
根据各种实施方式,联锁装置可包括(1)阻止机构,用于在没有未用尽的钉仓38安装在通道26中时防止马达106对切割器械34的致动,和(2)闭锁电路,用于检测通过马达106的电流并且根据检测到的电流来中断通过马达106的电流。
图31是根据各种实施方式通过联锁装置执行的过程的流程图。在步骤264,在没有未用尽的钉仓38安装在通道26中时通过阻止机构以机械方式阻止马达106对切割器械34的致动。如下面要说明的,阻止机构可包括传统机械联锁装置的组成元件或者零件。
在步骤266,通过闭锁电路检测由于阻止切割器械34的致动而导致的通过马达106的电流。如下面要说明的,电流的检测可包括例如感测马达电流、生成代表所感测电流的信号以及将生成的信号与阈值信号比较的步骤。
在步骤268,根据检测的电流中断通过马达106的电流。中断电流可包括例如在步骤266的比较结果表明生成的信号超过阈值信号时中断电流。中断通过马达106的电流还包括根据切割器械34的位置中断电流。
根据各种实施方式,联锁装置的阻止机构可包括类似于或等同于传统机械联锁装置的零部件,用于在没有未用尽的钉仓38安装在通道26中时以物理方式阻止切割器械34的前进。图13示出了根据一种实施方式的阻止机构196。该阻止机构196公开于Shelton,IV等人的名称为“SURGICAL STAPLING INSTRUMENT HAVING A SINGLELOCKOUT MECHANISM FOR PREVENTION OF FIRING”的美国专利No.7,044,352中,该文献通过引用结合入本文。如图所示,阻止机构196可包括定位于通道26中的一对弹簧夹198。特别是,弹簧夹196可升起,以便在滑块36(图13中未示出)没有处于通道26的近端处的未击发位置时(诸如未安装钉仓38或钉仓38安装但已用尽时)阻止切割器械34的中间销50。尽管示出了两个弹簧夹198,但是应当理解,可使用更多或更少的弹簧夹198。
图14至17示出了在器械10被击发后弹簧夹198随后的操作。在图14中,未用尽的钉仓38已插入通道26中。处于未击发位置的滑块36压下弹簧夹198,使得中间销50将通过的击发驱动槽200畅通无阻。
在图15中,钉仓38的击发已开始,并且滑块36和切割器械34的中间销50已经向远侧经过弹簧夹198,弹簧夹198弹起到击发驱动槽200中。
在图16中,钉仓38在该时刻已用尽,并且滑块36被完全驱动到远侧,没有再描绘出。切割器械34正在被向近侧缩回。由于弹簧夹198从更远侧的点枢转,切割器械34的中间销50能够在缩回过程中升到弹簧夹198之上,从而将弹簧夹198下压出击发驱动槽200。
在图17中,切割器械34完全缩回并且在该时刻靠着没有压下的成对弹簧夹198,以防止向远侧运动。阻止机构196由此保持启动,直到未用尽的钉仓38被安装到通道26中。
图18示出了根据另一种实施方式的阻止机构202。在上面参考的美国专利No.7,044,352中公开了阻止机构202,其包括一对钩204,钩204具有相对于连接装置208置于远侧的倾斜端部206。连接装置208插入穿过通道26中的孔210,由此将钩204弹性地连接到通道26。倾斜端部206位于通道26中形成的钩槽212上方。由此,当未用尽钉仓38的滑块36(在图18中未示出)接触每个倾斜端部206时,倾斜端部206被压进钩槽212中,由此为切割器械34的中间销50向远侧运动穿过击发驱动槽200让路,从而致动钉仓38。分别将连接装置208连接到每个钩204的倾斜端部206的细轴214弹性地响应于滑块36的缺位,如图所示,倾斜端部206回位,阻止击发驱动槽200,以阻挡切割器械34的缩回的中间销50。尽管示出了两个钩204,但是应当理解,可以使用更多或更少的钩204。
图19至22示出了钩204的随后操作。在图19中,钉仓38未用尽,位于远侧的滑块36将倾斜端部206压进钩槽212中,从而允许切割器械34的中间销50在击发过程中向远侧运动经过击发驱动槽200,如图20所示。在滑块36和中间销50相对于阻止机构202向远侧离开后,倾斜端部206弹性地升起到钩槽212外,占据击发驱动槽200。
在图21中,切割器械34正在缩回到接触钩204的倾斜端部206的点。由于倾斜端部206的远端低于倾斜端部206近侧部分,切割器械34的中间销50跨到倾斜端部206之上,从而迫使倾斜端部206向下进入钩槽212,直到中间销50经过倾斜端部206,如图22所示,其中倾斜端部206向上弹性地弹回,从而阻挡中间销50。由此,防止了切割器械34向远侧运动,直到未用尽的钉仓38安装到通道26中。
图23示出了根据另一种实施方式的阻止机构216。该阻止机构216公开于Shelton,IV等人的发明名称为“SURGICAL STAPLINGINSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT”的美国专利No.6,988,649,该文献通过引用结合入本文。阻止机构216与钉仓38一体形成,并且可包括弹性地定位在滑块36(图23中未示出)上方的向近侧凸出的阻挡构件218。特别地,阻挡构件218各个位于向下且向近侧打开的腔220中。每个阻挡构件218包括保持在腔220中的板簧端222。
腔220竖直对准并间隔开,且与钉仓38中的朝向近侧的竖直槽224平行,切割表面56(在图23中未示出)经过该竖直槽224。钉仓38还包括槽226,其纵向经过钉仓38,从钉仓38的近侧下面的一部分开口,以便接收滑块36。
每个阻挡构件218具有可偏斜端部228,该可偏斜端部228具有倾斜远侧227和阻挡用近侧229。如此成形阻挡构件218,当其被压下时其置于相应的腔220内,当其被松开时其阻止切割器械34的中间销50向远侧运动。
图24至27示出了在器械10被击发后阻止机构216随后的操作。在图24中,未用尽的钉仓38已插入通道26中,并且滑块36向上压可偏斜端部228,使得击发驱动槽200畅通无阻。
在图25中,钉仓38的击发已开始,并且滑块36和切割器械34的中间销50已经向远侧经过可偏斜端部228,然后可偏斜端部228向下弹回到击发驱动槽200中。
在图26中,钉仓38在该时刻已用尽,并且滑块36被完全驱动到远侧,没有再描绘出。切割器械34正在被向近侧缩回。由于可偏斜端部228从一更远侧的点枢转,切割器械34的中间销50能够在缩回过程中位于可偏斜端部228的倾斜远侧227之下,从而使倾斜远侧227被升起离开击发驱动槽200。
在图27中,切割器械34完全缩回并且中间销50在该时刻靠着没有压下(松开)的成对可偏斜端部228的阻挡用近侧229,以防止向远侧运动。阻止机构216由此保持启动,直到未用尽的钉仓38被安装到通道26中。
以上讨论的实施方式中的阻止机构196、202、216仅仅是示例性的。应当理解,可使用其他合适的阻止机构,诸如Ortiz等人的发明名称为“LOCKOUT MECHANISMS AND SURGICAL INSTRUMENTSINCLUDING SAME”的美国专利申请No.11/266,961(其通过引用结合入本文)中公开的那些阻止机构。
图28是根据本发明的各种实施方式的器械10的电路231的示意图。在一些实施方式中,电路231可被容纳在手柄12中。除了传感器128、传感器156、158(分别示出为常断限制开关和常通限制开关)、电池104和马达106,电路231可包括单极双掷继电器230、单极单掷继电器232、双极双掷继电器234、电流传感器236、位置传感器238和电流检测模块240。继电器232、电流传感器236、位置传感器238和电流检测模块240一起形成闭锁电路241。如下所述,闭锁电路241运行,以感测通过马达106的电流并且根据所感测的电流中断电流,由此通过使器械10不能操作而将其“锁定”。
如上所述,在锁定闭合扳机22之后操作者向内拉动击发扳机24时传感器128启动。当开关156断开时(表明端部执行器16的切割/缝合操作还未完成),继电器230(继电器A)的线圈242去激励,由此通过继电器230的常通触点在电池104和继电器232之间形成导电通路。继电器232(继电器B)的线圈244通过电流检测模块240和位置传感器238控制,如下所述。当线圈242和244去激励时,电池104和继电器234(继电器C)的常通触点之间的导电通路形成。继电器234根据开关156、158的状态控制马达106的旋转方向。当开关156断开并且开关158接通时(表明切割器械34还未向远侧完全展开),继电器234的线圈246去激励。由此,当线圈242、244、246一起去激励时,来自电池104的电流借助继电器234的常通触点流过马达106,并且导致马达106的前向旋转,这又导致切割器械34向远侧展开,如上所述。
当开关156接通时(表明切割器械34已经向远侧完全展开),继电器230的线圈242受到激励,并且通过继电器230的常断触点激励继电器234的线圈246。由此,在该时刻电流借助继电器230、234的常断触点流到马达106,由此使马达106反向旋转,这又导致切割器械34从其远侧位置缩回并且开关156断开。继电器230的线圈242保持受激励,直到限制开关158断开,表明切割器械34完全缩回。
在马达106前向旋转期间通过马达106的电流大小表示出在切割器械34展开期间施加在其上的力。如上所述,没有未用尽的钉仓38处于通道26中(例如存在用尽的钉仓38或者没有钉仓38等)导致阻止机构196、202、216启动,从而防止切割器械34向远侧运动。阻止机构196、202、216向切割器械34施加的阻力导致马达转矩增大,由此导致马达电流增加到比在切割和缝合操作过程中存在的电流水平明显要大的水平。由此,通过感测流过马达106的电流,闭锁电路241可以区分在未用尽钉仓38安装在通道26中时切割器械34的展开以及在没有未用尽钉仓38位于通道26中时切割器械34的展开。
电流传感器236可连接到电路231的在马达106前向旋转期间将电流引导到马达106的路径上。电流传感器236可为适合于产生表示所感测到的马达电流的信号(例如电压信号)的任何电流感测装置(例如分流电阻器、霍尔效应换流器等)。所生成的信号可被输入电流检测模块240,在其中进行处理,如下所述。
根据各种实施方式,电流检测模块240可被构造成将电流传感器236生成的信号与阈值信号(例如阈值电压信号)进行比较,从而确定阻止机构196、202、216是否已经启动。对于给定的器械10,阈值信号的合适值可以是根据经验确定的先验值,通过例如如下方式确定:在切割和缝合操作过程中切割器械34初始展开(例如在其远侧运动的前0.06英寸)时,以及在切割器械34展开并遇到启动的阻止机构196、202、216时,测量通过电流传感器236生成的峰值信号。可将阈值信号值选择成小于在阻止机构196、202、216启动时测量的峰值信号、但是大于在切割和缝合操作过程中测量到的峰值信号。
在一些实施方式中并且如图28所示,电流检测模块240可包括比较电路248,用于接收阈值和电流传感器236的信号并且根据所接收的信号的比较生成离散输出。例如,当超过阈值信号时比较电路248可生成5V DC输出,当未超过阈值信号时比较电路248可生成0V DC输出。例如可使用合适的信号参考电路(例如电压参考电路)(未示出)生成阈值信号。比较电路248和信号参考电路的设计和操作在现有技术中是公知的,此处不再赘述。
阈值信号和电流传感器236信号的比较结果是在切割器械34的初始展开过程中(例如在远侧运动的最初0.06英寸过程中)主要关心的问题。因此,电流检测模块240可根据由位置传感器238标示的切割器械34的远侧位置而限制比较。位置传感器238可以是适合于生成表示切割器械34的远侧位置的信号的任何类型的位置感测装置。在一种实施方式中,如图28所示,例如,位置传感器238可为常断霍尔效应位置开关238,根据其安装在环126上的磁体的接近度而受到致动。位置开关238可被安装在手柄12内,并且如下操作,当切割器械34的远侧位置(环126的位置标示的位置)位于其最近侧位置的预定距离处(例如远侧位置<0.06英寸)时,位置开关238接通。相反地,当切割器械34的远侧位置超过预定距离(例如远侧位置>0.06英寸)时,位置开关238断开。位置开关238可与比较电路248的输出串联连接,以便根据切割器械34的位置限制比较。这样,如果当切割器械34的远侧位置大于预定距离时超过阈值信号,位置开关238的输出将保持在0V DC(根据上述实例),而与比较结果无关。应当理解,作为上述霍尔效应位置开关238的替代方式,可替代使用其它类型的位置传感器238(例如机械致动限制开关、旋转电位计等)。另外,应当理解,作为单独的位置传感器238的替代方式,可使用开关158的辅助触点(未示出)。在其中位置传感器238不包括切换输出(例如当位置传感器238是电位计或其它基于模拟技术的位置传感器)的实施方式中,使用例如第二比较电路进行位置传感器236输出的附加处理可能是必须的。
如图28所示,位置开关238的输出可连接到继电器232的线圈244。如果需要,可设置位于位置开关238和线圈244之间的驱动器电路(未示出)。由此,如果电流传感器236生成的信号超过阈值信号(表示由于缺少未用尽钉仓38而启动阻止机构196、202、216),并且切割器械34处于其最近侧位置的预定距离内,则线圈244受到激励。这使得继电器232的常通开关断开,由此中断流向马达106的电流并去除阻止机构196、202、216施加在切割器械34上的阻力。重要的是,由于阻止机构196、202、216仅需要施加足以导致超过阈值信号的机械阻止力,所以与仅使用传统机械联锁装置所施加的应力的大小和持续时间相比,阻止机构196、202、216施加的物理应力的大小和持续时间都减小了。而且,由于所述联锁装置不需要位于端部执行器16中的电子传感器,所以简化了器械设计。
图29是根据本发明另一实施方式的器械10的电路249的示意图,其中基于处理器的微控制器250用于执行上述闭锁电路241的功能。尽管为了清楚起见未示出,微控制器250可包括微控制器领域公知的组成元件,诸如例如处理器、随机存取存储器(RAM)单元、可擦可编程只读存储器(EPROM)单元、中断控制器单元、定时器单元、模数转换器(ADC)单元和数模转换器(DAC)单元、以及用于接收和发送数字和模拟信号的多个通用输入/输出(I/O)端口。电流传感器236和位置传感器238可分别连接到微控制器250的模拟和数字输入,并且继电器232的线圈244可连接到微控制器250的数字输出。应当理解,在其中位置传感器238的输出是模拟信号的实施方式中,位置传感器238可连接到模拟输入。另外,尽管图29的电路249包括继电器230、232、234,应当理解,在其它实施方式中,继电器开关功能可由实体开关装置、软件及其组合来代替。在一些实施方式中,例如,在微控制器250中存储和执行的指令可用于控制微控制器250的实体状态切换的输出。在这种实施方式中,开关156、158可被连接到微控制器250的数字输出。
图30是根据各种实施方式的微控制器250执行的程序的流程图。在步骤252,微控制器250借助模拟输入接收电流传感器236生成的信号并将所接收的信号转换成相应的电流传感器数字信号。
在步骤254,将电流传感器数字信号的值与存储在微控制器250内的数字阈值相比较。数字阈值可以是例如参照图28在前面说明的阈值信号的数字化表示。如果电流传感器数字信号值小于数字阈值,则程序中止于步骤256。如果电流传感器数字信号值大于数字阈值,则程序前进到步骤258。
在步骤258,处理位置传感器238的输入,以便确定切割器械34是否处于其最近侧位置的预定距离。如果切割器械34未处于预定距离内,程序终止于步骤260。如果切割器械34处于预定距离内,程序前进到步骤262。
在步骤262,激励对应于线圈244的数字输出,由此使继电器232的常通触点断开,这又使流到马达106的电流中断。
尽管在上述实施方式中将电流传感器信号的大小(或者其数字化形式)与阈值信号或值比较,但是应当理解,用于分析电流传感器信号的其他度量标准可附加地或替代地用于区分在未用尽钉仓38安装在通道26中时切割器械34的展开以及在没有未用尽钉仓38位于通道26中时切割器械34的展开。例如,电流检测模块240或微控制器250可被构造成确定电流传感器信号的导数和/或积分特征,用于与相应的阈值信号或值比较。另外,在一些实施方式中,电流传感器信号可在分析前使用例如信号调节器和/或执行一个或多个滤波器频响特性功能(例如无限脉冲响应功能)的滤波器来处理。
上面已经关于切割型外科器械说明了本发明的各种实施方式。但是,应当理解,在其他实施方式中,此处公开的创造性的外科器械不必是切割型外科器械。例如,其可以是非切割内镜器械、抓钳、缝合器、夹施放器、进入装置、药物/基因治疗输送装置、使用超声、RF、激光等能量的能量装置。
此处公开的装置可被设计成可被设计为在一次使用后丢弃,或者它们可被设计为可多次使用。但是,在任何一种情形中,所述装置在至少使用一次后可被复原再使用。复原包括以下步骤的任意组合,即,拆分装置,然后清洗或者替换具体的零件,之后重新组装。尤其是,所述装置可被拆卸,装置的任何数量的其它零件或部分也可被可选地以任何组合替换或移除。在具体零件的清洗和/或替换后,该装置可以在复原厂或者正好在外科手术之前由外科组重新组装,以用于随后的使用。本领域技术人员将会理解,可采用各种拆分、清洗/替换和重新组装技术来使装置复原。这类技术的使用以及最终的复原的装置都在本申请的范围内。
尽管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,但是可执行对这些实施方式的任何修改和变化。例如,可采用不同类型的端部执行器。而且,对于其中材料被公开用于一些元件的情况,其它材料也可被使用。前述描述和下面的权利要求书将覆盖所有这些修改和变化。
声称通过引用被包含在本申请的任何专利、出版物或者其它公开材料,全部或部分,仅仅包含到所包含的材料不与现有定义、表述或者在该公开文本中阐明的其它公开材料相冲突的程度。这样,并到必要的程度,在本文中明确阐明的公开内容取代任何通过引用包含在本文中的相冲突的材料。声称通过引用包含在本申请中但与现有定义、表述或者其它公开材料相冲突的任何材料或者其部分仅仅被包含到不引起包含的材料与现有公开材料之间的冲突的程度。

Claims (10)

1.一种外科器械,包括:
具有用于切割物体的可动切割器械的端部执行器;
连接到所述端部执行器的马达,用于响应于通过其的电流来致动所述切割器械,其中所述切割器械的致动使该切割器械在最近侧位置和最远侧位置之间运动;以及
连接到所述端部执行器和所述马达上的联锁装置,用于基于通过所述马达的电流防止所述切割器械的致动。
2.如权利要求1所述的器械,其中,所述端部执行器还包括:
纵向延伸通道,所述通道具有近端和远端;
以可枢转的方式连接到所述通道的钉砧,其中所述物体位于所述钉砧和所述通道之间;
以可拆卸的方式置于所述通道中的钉仓,所述钉仓具有近端和远端;
形成于所述钉仓和所述通道之间的击发驱动槽,当所述切割器械被致动时至少部分所述切割器械经过所述击发驱动槽;以及
设置于所述钉仓中的滑块,其中当所述切割器械被致动时所述滑块由所述切割器械接合,并被从位于所述钉仓近端的未击发位置纵向驱动穿过该钉仓到达位于所述钉仓远端的击发位置。
3.如权利要求2所述的器械,其中,所述联锁装置包括:
用于防止所述切割器械的致动的阻止机构,其中在所述滑块未处于未击发位置时启动所述阻止机构;以及
用于感测通过所述马达的电流并根据所感测的电流来中断通过所述马达的电流的闭锁电路。
4.如权利要求3所述的器械,其中,所述闭锁电路还用于根据所述切割器械的位置来中断通过所述马达的电流。
5.如权利要求3所述的器械,其中,当所述阻止机构阻止所述切割器械纵向前进通过所述通道时,通过所述马达的电流增大。
6.如权利要求3所述的器械,其中,所述阻止机构包括至少一个设置在所述通道中的弹簧夹。
7.如权利要求3所述的器械,其中,所述阻止机构包括至少一个弹性地连接到所述通道的倾斜钩。
8.如权利要求3所述的器械,其中,所述阻止机构与所述钉仓一体形成,并且包括至少一个向近侧凸出的构件,其中所述至少一个向近侧凸出的构件能够在所述击发驱动槽和所述钉仓中的凹槽之间运动。
9.如权利要求3所述的器械,其中,所述闭锁电路包括用于生成代表所感测电流的第一信号的电流传感器。
10.如权利要求9所述的器械,其中,所述闭锁电路还包括用于将所述第一信号与预定阈值信号进行比较的电流检测模块。
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