CN101683280A - 访问存储在外科器械的存储器中的数据 - Google Patents

访问存储在外科器械的存储器中的数据 Download PDF

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CN101683280A
CN101683280A CN200910175031A CN200910175031A CN101683280A CN 101683280 A CN101683280 A CN 101683280A CN 200910175031 A CN200910175031 A CN 200910175031A CN 200910175031 A CN200910175031 A CN 200910175031A CN 101683280 A CN101683280 A CN 101683280A
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closed
trigger
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F·E·谢尔顿四世
D·C·耶茨
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Ethicon Endo Surgery Inc
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Abstract

本发明公开了访问存储在外科器械的存储器中的数据。更具体地，本发明公开了用于将存储在外科切割和紧固器械的存储装置中的传感器数据下载到外部或远程计算机装置的过程和系统。该过程可以包括在涉及外科切割和紧固器械的外科手术过程中将来自外科切割和紧固器械的一个或多个传感器的数据存储在该外科切割和紧固器械的控制单元的存储装置中。接着，在外科手术之后在控制单元和远程计算机装置之间建立数据链路。然后，可以将传感器数据从控制单元下载到远程计算机装置。

Description

访问存储在外科器械的存储器中的数据
优先权要求
根据3 5 U.S.C.§120，本申请是Shelton等人于2006年1月31日提交的题为“Surgical Instrument Having Recording Capabilities”、序列号为No.11/343803的共同未决美国专利申请的部分连续申请，该申请的全部内容通过引用合并在此。
相关申请的交叉引用
本申请涉及以下美国专利申请，这些专利申请与前段引用的序列号为No.11/343803的美国专利申请是同时提交的，并且这些专利申请的全部内容通过引用合并在此：
(1)Frederick E.Shelton，IV，John Ouwerkerk和Jerome R.Morgan的题为“MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH USER FEEDBACK SYSTEM”、序列号为No.11/343498的美国专利申请；
(2)Frederick E.Shelton，IV，John N.Ouwerkerk，Jerome R.Morgan和Jeffrey S.Swayze的题为“MOTOR-DRIVEN SURGICALCUTTING AND FASTENING INSTRUMENT WITH LOADINGFORCE FEEDBACK”、序列号为No.11/343573的美国专利申请；
(3)Frederick E.Shelton，IV，John N.Ouwerkerk，Jerome R.Morgan和Jeffrey S.Swayze的题为“MOTOR-DRIVEN SURGICALCUTTING AND FASTENING INSTRUMENT WITH TACTILEPOSITION FEEDBACK”、序列号为No.11/344035的美国专利申请；
(4)Frederick E.Shelton，IV，John N.Ouwerkerk和Jerome R.Morgan的题为“MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH ADAPTIVE USER FEEDBACK”、序列号为No.11/343447的美国专利申请；
(5)Frederick E.Shelton，IV和Christoph L.Gillum的题为“MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH ARTICULATABLE END EFFECTOR”、序列号为No.11/343562的美国专利申请；
(6)Frederick E.Shelton，IV和Christoph L.Gillum的题为“MOTOR-DRIVEN SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH MECHANICAL CLOSURE SYSTEM”、序列号为No.11/344024的美国专利申请；
(7)Frederick E.Shelton，IV和Kevin R.Doll的题为“SURGICALCUTTING AND FASTENING INSTRUMENT WITH CLOSURETRIGGER LOCKING MECHANISM”、序列号为No.11/343321的美国专利申请；
(8)Frederick E.Shelton，IV，Jeffrey S.Swayze，Eugene L.Timperman的题为“GEARING SELECTOR FOR A POWEREDSURGICAL CUTTING AND FASTENING STAPLINGINSTRUMENT”、序列号为No.11/343563的美国专利申请；
(9)Frederick E.Shelton，IV，Kevin R.Doll，Jeffrey S.Swayze和Eugene Timperman的题为“SURGICAL INSTRUMENT HAVING AREMOVABLE BATTERY”、序列号为No.11/344020的美国专利申请；
(10)Jeffrey S.Swayze，Frederick E.Shelton，IV，Kevin R.Doll的题为“ELECTRONIC LOCKOUTS AND SURGICAL INSTRUMENTINCLUDING SAME”、序列号为No.11/343439的美国专利申请；
(11)Frederick E.Shelton，IV，Jeffrey S.Swayze，Mark S.Ortiz和Leslie M.Fugikawa的题为“ENDOSCOPIC SURGICALINSTRUMENT WITH A HANDLE THAT CAN ARTICULATE WITHRESPECT TO THE SHAFT”、序列号为No.11/343547的美国专利申请；
(12)Frederick E.Shelton，IV，Stephen J.Balek和Eugene L.Timperman的题为“ELECTRO-MECHANICAL SURGICAL CUTTINGAND FASTENING INSTRUMENT HAVING A POTARY FIRINGAND CLOSURE SYSTEM WITH PARALLEL CLOSURE ANDANVIL ALIGNMENT COMPONENTS”、序列号为No.11/344021的美国专利申请；
(13)Frederick E.Shelton，IV，Michael S.Cropper，Joshua M.Broehl，Ryan S.Crisp，Jamison J.Float，Eugene L.Timperman的题为“DISPOSABLE STAPLE CARTRIDGE HAVING AN ANVIL WITHTISSUE LOCATOR FOR USE WITH A SURGICAL CUTTING ANDFASTENING INSTRUMENT AND MODULAR END EFFECTORSYSTEM THEREFOR”、序列号为No.11/343546的美国专利申请；以及
(14)Frederick E.Shelton，IV，Jerome R.Morgan，Kevin R.Doll，Jeffrey S. Swayze和Eugene Timperman的题为“SURGICALINSTRUMENT HAVING A FEEDBACK SYSTEM”、序列号为No.11/343545的美国专利申请。
技术领域
本发明整体涉及外科器械，更具体地，涉及能够记录器械的各种状况的微创外科器械。
背景技术
内窥镜式外科器械通常优于传统的开放式外科装置，这是因为较小的切口易于缩短术后恢复时间并减少并发症。因此，内窥镜式外科器械得到了显著的发展，其适用于将远侧端部执行器穿过套管针的套管精确地放置在期望的外科手术部位。这些远侧端部执行器以多种方式接合组织，以达到诊断或治疗效果(例如，内切割器、抓紧器、切割器、缝合器、夹子施用器、接近装置、药物/基因治疗输送装置，以及利用超声、RF、激光等的能量装置)。
已知的外科缝合器包括对组织进行纵向切开的同时向切口的相对侧施加缝合线的端部执行器。端部执行器包括一对相互协作的钳口构件，如果器械被指定用在内窥镜或腹腔镜应用中，那么上述一对相互协作的钳口构件能够通过套管通道。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具有与钉仓中的缝钉排对准的缝钉成形凹窝的砧座。器械包括多个往复运动的楔形件，楔形件在被向远侧驱动时通过钉仓中的开口并且接合支撑缝钉的驱动器以朝向砧座执行缝钉的击发。
Knodel等人的题为“SURGICAL STAPLER INSTRUMENT”的美国专利No.5465895中描述了适用于内窥镜应用的外科缝合器的一个例子，该美国专利公开了具有不同的闭合和击发动作的内切割器。使用该装置的临床医生能够在组织上闭合钳口构件以在击发之前定位组织。一旦临床医生确定钳口构件适当地抓持组织，临床医生然后可以击发单个击发行程或多个击发行程(这依赖于装置)的外科缝合器。击发外科缝合器致使切割和缝合组织。同时切割和缝合避免了在利用分别仅切割和缝合的不同的外科工具顺序地执行这些动作时会出现的并发症。
能够在击发之前在组织上闭合的一个具体的优点是临床医生能够经由内窥镜证实已经到达要进行切割的期望位置，包括在相对的钳口之间已经捕获了足量的组织。否则，相对的钳口构件可能被过近地拉在一起，特别是它们的远端夹紧，并由此不能有效地在被切断的组织中形成闭合的缝钉。在另一种极限情况中，被夹钳的过量的组织会导致受束缚的和不完全的击发。
当内窥镜式外科器械产生故障时，通常是将它们返回到制造商或其它机构来分析故障原因。如果故障导致器械中出现了严重的缺陷，那么制造商必须确定故障的原因并确定是否需要改变设计。在这种情况下，制造商可能花费数百小时的人工时间来分析产生故障的器械并试图重新建立状况，在这些状况下，器械仅在受到损坏时才出现故障。以这种方式分析器械器械故障是很昂贵且具有挑战性的。同样，许多这样的分析简单地归结于故障是由于未适当地使用器械造成的。
发明内容
在一个总的方面中，本发明涉及一种用于将存储在外科切割和紧固器械的存储装置中的传感器数据下载到外部或远程计算机装置的过程和系统。根据各种实施方式，该过程包括在涉及外科切割和紧固器械的外科手术过程中将来自外科切割和紧固器械的一个或多个传感器的数据存储在该外科切割和紧固器械的控制单元的存储装置中。接着，在所述外科手术之后在所述控制单元和远程计算机装置之间建立数据链路。然后，将传感器数据从控制单元下载到远程计算机装置。传感器例如可以包括：感测闭合扳机致动的闭合扳机传感器；用于感测砧座闭合的砧座闭合传感器；感测在砧座闭合时由砧座施加在钉仓上的载荷的砧座闭合载荷传感器；用于感测击发扳机致动的击发扳机传感器；用于感测刀在端部执行器中的位置的刀位置传感器；用于检测钉仓是否在端部执行器中的钉仓存在传感器；用于检测钉仓的状况的钉仓状况传感器；以及用于检测端部执行器关节运动的关节运动传感器。
本发明具体公开了以下内容：
(1).一种方法，包括：
在涉及外科切割和紧固器械的外科手术过程中将来自外科切割和紧固器械的至少一个传感器的数据存储在该外科切割和紧固器械的控制单元的存储装置中；
在所述外科手术之后在所述控制单元和远程计算机装置之间建立数据链路；并且
将所述数据从所述外科切割和紧固器械的所述控制单元下载到所述远程计算机装置。
(2).根据第(1)项所述的方法，其中，所述数据链路包括有线数据链路。
(3).根据第(1)项所述的方法，其中，所述数据链路包括无线数据链路。
(4).根据第(1)项所述的方法，还包括：
在将所述数据存储在所述存储装置中之前对所述数据进行加密；并且
在将所述数据下载到所述远程计算机装置之后对所述数据进行解密。
(5).根据第(1)项所述的方法，其中，所述外科切割和紧固器械包括：
手柄；
连接到所述手柄上的轴；以及
连接到所述轴上的端部执行器，所述端部执行器包括可枢转地连接的、相对的第一钳口构件和第二钳口构件。
(6).根据第(5)项所述的方法，其中：
所述手柄包括击发扳机；并且
所述端部执行器包括切割器械，所述切割器械在所述击发扳机被致动时沿纵向穿过所述端部执行器。
(7).根据第(6)项所述的方法，其中，所述手柄还包括与所述击发扳机分离的闭合扳机，所述闭合扳机用于在被致动时使所述第一钳口构件和第二钳口构件将组织夹钳在所述第一钳口构件和第二钳口构件之间。
(8).根据第(7)项所述的方法，其中：
所述至少一个传感器包括与所述控制单元通信的砧座闭合传感器，所述砧座闭合传感器感测所述第二钳口构件的闭合；并且
所述控制单元的所述存储装置存储来自所述砧座闭合传感器的数据。
(9).根据第(7)项所述的方法，其中：
所述至少一个传感器包括与所述控制单元通信的闭合扳机传感器，所述闭合扳机传感器感测所述闭合扳机的致动；并且
所述控制单元的所述存储装置存储来自所述闭合扳机传感器的数据。
(10).根据第(7)项所述的方法，其中：
所述至少一个传感器包括位于所述第一钳口构件中并且与所述控制单元通信的砧座闭合载荷传感器，所述砧座闭合载荷传感器感测由于所述第二钳口构件的闭合而施加在所述第一钳口构件上的载荷；并且
所述控制单元的所述存储装置存储来自所述砧座闭合载荷传感器的数据。
(11).根据第(6)项所述的方法，其中：
所述至少一个传感器包括与所述控制单元通信的击发扳机传感器，所述击发扳机传感器感测所述击发扳机的致动；并且
所述控制单元的所述存储装置存储来自所述击发扳机传感器的数据。
(12).根据第(6)项所述的方法，其中：
所述至少一个传感器包括位于所述端部执行器中并且与所述控制单元通信的切割器械位置传感器，所述切割器械位置传感器感测所述切割器械在所述端部执行器中的位置；并且
所述控制单元的所述存储装置存储来自所述切割器械位置传感器的数据。
(13).根据第(7)项所述的方法，其中，所述第一钳口构件包括用于承载可更换钉仓的通道。
(14).根据第(13)项所述的方法，其中：
所述至少一个传感器包括位于所述端部执行器中并且与所述控制单元通信的钉仓存在传感器，所述钉仓存在传感器感测钉仓是否存在于所述端部执行器中；并且
所述控制单元的所述存储装置存储来自所述钉仓存在传感器的数据。
(15).根据第(13)项所述的方法，其中：
所述至少一个传感器包括位于所述端部执行器中并且与所述控制单元通信的钉仓状况传感器，所述钉仓状况传感器感测所述钉仓的状况；并且
所述控制单元的所述存储装置存储来自所述钉仓状况传感器的数据。
(16).根据第(6)项所述的方法，其中：
所述至少一个传感器包括与所述控制单元通信的关节运动传感器，所述关节运动传感器感测所述端部执行器的关节运动；并且
所述控制单元的所述存储装置存储来自所述关节运动传感器的数据。
(17).一种系统，包括：
外科切割和紧固器械，其中所述外科切割和紧固器械包括：
包括存储装置的控制单元；和
与所述控制单元通信的至少一个传感器，其中所述存储装置存储来自所述至少一个传感器的数据；以及
经由数据链路与所述外科切割和紧固器械的所述控制单元通信的外部计算机装置，其中所述外部计算机装置用于从所述外科切割和紧固器械的所述控制单元的存储装置下载数据。
(18).根据第(17)项所述的系统，其中，所述数据传输包括有线数据链路。
(19).根据第(17)项所述的系统，其中，所述数据传输包括无线数据链路。
(20).根据第(17)项所述的系统，其中，所述外科切割和紧固器械包括：
手柄；
连接到所述手柄的轴；以及
连接到所述轴的端部执行器，所述端部执行器包括可枢转地连接的、相对的第一钳口构件和第二钳口构件。
(21).根据第(20)项所述的系统，其中：
所述手柄包括击发扳机；并且
所述端部执行器包括切割器械，所述切割器械在所述击发扳机被致动时沿纵向穿过所述端部执行器。
(22).根据第(21)项所述的系统，其中，所述手柄还包括与所述击发扳机分离的闭合扳机，所述闭合扳机用于在被致动时使所述第一钳口构件和第二钳口构件将组织夹钳在所述第一钳口构件和第二钳口构件之间。
(23).根据第(22)项所述的系统，其中：
所述至少一个传感器包括与所述控制单元通信的砧座闭合传感器，所述砧座闭合传感器感测所述第二钳口构件的闭合；并且
所述控制单元的所述存储装置存储来自所述砧座闭合传感器的数据。
(24).根据第(22)项所述的系统，其中：
所述至少一个传感器包括与所述控制单元通信的闭合扳机传感器，所述闭合扳机传感器感测所述闭合扳机的致动；并且
所述控制单元的所述存储装置存储来自所述闭合扳机传感器的数据。
(25).根据第(22)项所述的系统，其中：
所述至少一个传感器包括位于所述第一钳口构件中并且与所述控制单元通信的砧座闭合载荷传感器，所述砧座闭合载荷传感器感测由于所述第二钳口构件的闭合而施加在所述第一钳口构件上的载荷；并且
所述控制单元的所述存储装置存储来自所述砧座闭合载荷传感器的数据。
(26).根据第(21)项所述的系统，其中：
所述至少一个传感器包括与所述控制单元通信的击发扳机传感器，所述击发扳机传感器感测所述击发扳机的致动；并且
所述控制单元的所述存储装置存储来自所述击发扳机传感器的数据。
(27).根据第(21)项所述的系统，其中：
所述至少一个传感器包括位于所述端部执行器中并且与所述控制单元通信的切割器械位置传感器，所述切割器械位置传感器感测所述切割器械在所述端部执行器中的位置；并且
所述控制单元的所述存储装置存储来自所述切割器械位置传感器的数据。
(28).根据第(22)项所述的系统，其中，所述第一钳口构件包括用于承载可更换钉仓的通道。
(29).根据第(28)项所述的系统，其中：
所述至少一个传感器包括位于所述端部执行器中并且与所述控制单元通信的钉仓存在传感器，所述钉仓存在传感器感测钉仓是否存在于所述端部执行器中；并且
所述控制单元的所述存储装置存储来自所述钉仓存在传感器的数据。
(30).根据第(28)项所述的系统，其中：
所述至少一个传感器包括位于所述端部执行器中并且与所述控制单元通信的钉仓状况传感器，所述钉仓状况传感器感测所述钉仓的状况；并且
所述控制单元的所述存储装置存储来自所述钉仓状况传感器的数据。
(31).根据第(21)项所述的系统，其中：
所述至少一个传感器包括与所述控制单元通信的关节运动传感器，所述关节运动传感器感测所述端部执行器的关节运动；并且
所述控制单元的所述存储装置存储来自所述关节运动传感器的数据。
附图说明
这里通过与以下附图结合的实施例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10A和10B示出了根据本发明的各种实施方式可以使用的比例传感器；
图11是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至13是根据本发明的其它实施方式的手柄的侧视图；
图14至22示出了根据本发明的各种实施方式用于锁定闭合扳机的不同机构；
图23A-B示出了根据本发明的各种实施方式可以用在器械的关节运动位置处的万向接头(“U形接头”)；
图24A-B示出了根据本发明的各种实施方式可以用在器械的关节运动位置处的扭转缆线；
图25至31示出了根据本发明的另一种实施方式的具有动力辅助的外科切割和紧固器械；
图32至36示出了根据本发明的又一种实施方式的具有动力辅助的外科切割和紧固器械；
图37至40示出了根据本发明的实施方式的具有触觉反馈的外科切割和紧固器械；
图41示出了根据本发明的各种实施方式的器械的端部执行器和轴的分解图；
图42示出了根据本发明的各种实施方式的机械化器械的手柄的侧视图；
图43示出了图42的机械致动的器械的手柄的分解图；
图44示出了根据本发明的各种实施方式的用于记录器械的各种状况的记录系统的框图；
图45至46示出了根据本发明的各种实施方式的示出了各种传感器的器械的手柄的侧面剖视图；
图47示出了根据本发明的各种实施方式的示出了各种传感器的器械的端部执行器；
图48示出了根据本发明的各种实施方式的包括传感器的器械的击发杆；
图49示出了根据本发明的各种实施方式的示出了传感器的器械的手柄、端部执行器和击发杆的侧视图；
图50示出了根据本发明的各种实施方式的示出了各种传感器的器械的缝钉通道和钉仓部分的分解图；
图51示出了根据本发明的各种实施方式的示出了各种传感器的器械的缝钉通道的俯视图；
图52A和52B示出了用于操作根据各种实施方式的器械的方法的流程图；
图53是示出了根据本发明的各种实施方式的器械的示例性记录的状况的存储器图表；
图54是根据本发明的各种实施方式用于记录器械的各种状况的记录系统的框图；
图55是与远程计算机装置通信的外科器械的示意图；以及
图56是描绘了根据本发明的各种实施方式的过程的流程图。
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。图示的实施方式是内窥镜式外科器械10，并且总的来说，这里描述的器械10的实施方式是内窥镜式外科切割和紧固器械。但是，应当注意到，根据本发明的其它实施方式，器械10可以是非内窥镜式外科切割器械，例如腹腔镜式器械。
图1和2中示出的外科器械10包括手柄6、轴8以及在关节运动枢轴14处可枢转地连接到轴8上的关节运动端部执行器12。关节运动控制器16可以设置在手柄6附近，以使端部执行器12绕关节运动枢轴14旋转。可以理解的是，各种实施方式可以包括非枢转的端部执行器，并且因此可以不具有关节运动枢轴14或关节运动控制器16。同样，在图示的实施方式中，端部执行器12能够用作内切割器，用于夹钳、切断和缝合组织，但在其它实施方式中，可以使用不同类型的端部执行器，例如用于其它类型外科装置的端部执行器，例如抓紧器、切割器、缝合器、夹子施用器、进入装置、药物/基因治疗装置、超声、RF或激光装置等。
器械10的手柄6可以包括用于致动端部执行器12的闭合扳机18和击发扳机20。可以理解，具有用于不同外科任务的端部执行器的器械可以具有不同数量或类型的扳机或用于操作端部执行器12的其它适当的控制器。所示端部执行器12通过优选的是细长的轴8与手柄6分开。在一种实施方式中，临床医生或器械10的操作者可以通过利用关节运动控制器16使端部执行器12相对于轴8作关节运动，如Geoffrey C.Hueil等于2006年1月10日提交的题为“SurgicalInstrument Having An Articulating End Effector”、序列号为No.11/329020的未决美国专利申请中更加详细描述的，该美国专利申请的全部内容通过引用合并在此。
在本实施例中，端部执行器12包括缝钉通道22和可枢转移动的夹钳构件例如砧座24等，它们之间保持间距以确保被夹钳在端部执行器12中的组织被有效缝合和切断。手柄6包括手枪式握把26，临床医生朝向手枪式握把26枢转地拉动闭合扳机18以使砧座24朝着端部执行器12的缝钉通道22夹钳或闭合，由此夹钳定位在砧座24和通道22之间的组织。击发扳机20位于闭合扳机18外侧的较远处。一旦闭合扳机18被锁定在闭合位置，如下面进一步说明的，击发扳机20可以朝着手枪式握把26稍稍转动，使得其能够由操作者单手接触到。然后，操作者可以朝着手枪式握把26枢转地拉动击发扳机20，以对被夹钳在端部执行器12中的组织进行缝合和切断。在其它实施方式中，可以使用除了砧座24以外的不同类型的夹钳构件，例如相对的钳口等。
可以理解，这里使用的术语“近侧”和“远侧”是以抓持器械10的手柄6的临床医生为参照的。因此，端部执行器12相对于更近侧的手柄6位于远侧。为了方便和清楚起见，还可以理解，这里使用的例如“竖直的”和“水平的”等空间术语是以附图为参照的。但是，外科器械用在许多方向和位置，这些术语并不是限制性的和绝对的。
可以首先致动闭合扳机18。一旦临床医生对端部执行器12的位置满意，临床医生可以将闭合扳机18拉回到其位于手枪式握把26近侧的完全闭合、锁定的位置。然后可以致动击发扳机20。当临床医生移除压力时，击发扳机20返回到打开位置(如图1和2所示)，以下将对此进行更加充分的描述。手柄6上的释放按钮当被压下时可以释放被锁定的闭合扳机18。释放按钮可以实施为各种形式，例如图42至43中所示的释放按钮30、图14中所示的滑动释放按钮160和/或图16中所示的按钮172。
图3至6示出了根据各种实施方式的被旋转驱动的端部执行器12和轴8的实施方式。图3是根据各种实施方式的端部执行器12的分解图。如图示的实施方式所示，端部执行器12除了包括之前提及的通道22和砧座24之外还可以包括切割器械32、滑架33、可拆卸地安置在通道22中的钉仓34，以及螺旋丝杠36。切割器械32例如可以是刀。砧座24可以在连接到通道22的近端的枢销25处可枢转地打开和闭合。砧座24也可以包括位于其近端处的翼片27，该翼片27插入在机械闭合系统(以下进一步描述)的部件中，以打开和闭合砧座24。当闭合扳机18被致动，即，由器械10的使用者向内拉动时，砧座24可以围绕枢销25枢转到夹钳或闭合位置。如果满意于端部执行器12的夹钳，操作者可以致动击发扳机20，这使得刀32和滑架33沿着通道22纵向地行进，由此切割被夹钳在端部执行器12中的组织，如以下更加详细说明的。滑架33沿着通道22的运动致使钉仓34的缝钉(未示出)被驱动穿过被切断的组织并且抵接闭合的砧座24，这使缝钉变弯以紧固被切断的组织。在各种实施方式中，滑架33可以是钉仓34的一体的部件。Shelton，IV等人的题为“SURGICAL STAPLING INSTRUMENT INCORPORATING ANE-BEAM FIRING MECHANISM”的美国专利No.6978921提供了有关这种二行程切割和紧固器械的更详细的说明，该美国专利的全部内容通过引用合并在此。滑架33可以是钉仓34的一部分，使得当刀32在切割操作之后缩回时，滑架33不缩回。
应当注意的是，虽然这里描述的器械10的实施方式利用缝合被切断的组织的端部执行器12，但在其它实施方式中，可以采用用于紧固或密封被切断的组织的不同的技术。例如，也可以利用粘合剂或使用RF能量的端部执行器来紧固被切断的组织。Yates等人的题为“ELECTROSURGICAL HEMOSTATIC DEVICE”的美国专利No.5709680和Yates等人的题为“ELECTROSURGICAL HEMOSTATICDEVICE WITH RECESSED AND/OR OFFSET ELECTRODES”的美国专利No.5688270公开了一种利用RF能量来密封被切断的组织的内窥镜式切割器械，所述美国专利的全部内容通过引用合并在此。Jerome R.Morgan等人的序列号为No.11/267811的美国专利申请和Frederick E.Shelton，IV等人的序列号为No.11/267383的美国专利申请公开了利用粘合剂来紧固被切断的组织的切割器械，所述美国专利申请的全部内容也通过引用合并在此。因此，虽然本说明书涉及切割/缝合操作等，但应当认识到，这是示例性的实施方式并且不是限制性的。也可以利用其它组织紧固技术。
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。如图示实施方式所示，轴8可以包括通过枢轴连接件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，砧座24上的翼片27插入到开口45中以便打开和闭合砧座24，如以下进一步说明的。近侧脊管46可以设置在闭合管40、42内侧。经由锥齿轮组件52与辅助(或者远侧)传动轴50相连的主旋转(或者近侧)传动轴48可以设置在近侧脊管46的内侧。辅助传动轴50连接到传动齿轮54，传动齿轮54接合螺旋丝杠36的近侧传动齿轮56。竖直锥齿轮52b可以位于近侧脊管46的远端中的开口57内并能在该开口57内枢转。远侧脊管58可以用于包围辅助传动轴50和传动齿轮54、56。主传动轴48、辅助传动轴50和关节运动组件(例如锥齿轮组件52a-c)合起来在本文有时被称为“主传动轴组件”。
定位在缝钉通道22的远端处的支承件38接收螺旋丝杠36，使得螺旋丝杠36相对于通道22自由旋转。螺旋丝杠36可以与刀32的螺纹开口(未示出)交接，使得轴36的旋转致使刀32向远侧或近侧(这取决于旋转方向)移动通过缝钉通道22。因此，当主传动轴48由于击发扳机20的致动而旋转时(如以下更加详细说明的)，锥齿轮组件52a-c使得辅助传动轴50旋转，这又由于传动齿轮54、56的接合使得螺旋丝杠36旋转，这致使刀驱动构件32沿着通道22纵向地行进以切割被夹钳在端部执行器12内的任何组织。滑架33例如可以由塑料制成，并且可以具有倾斜的远侧表面。随着滑架33穿过通道22，倾斜的前向表面可以向上推动或者驱动钉仓中的缝钉穿过被夹钳的组织并且抵接砧座24。砧座24使缝钉变弯，由此缝合被切断的组织。当刀32缩回时，刀32和滑架33可以脱离接合，由此将滑架33留在通道22的远端处。
如上所述，由于缺乏对切割/缝合操作的使用者反馈，因此在仅通过按压按钮来致动切割/缝合操作的情况下医生普遍缺乏对马达驱动的内切割器的接受。相反，本发明的实施方式提供具有对切割器械32在端部执行器12内的展开、力和/或位置的使用者反馈的马达驱动的内切割器。
图7至10示出了马达驱动的内切割器、更具体的是其手柄的示例性的实施方式，其提供关于切割器械32在端部执行器12中的展开和载荷力的使用者反馈。另外，该实施方式可以利用使用者缩回击发扳机20提供的动力来向装置提供动力(所谓的“动力辅助”模式)。该实施方式可以与上述旋转驱动的端部执行器12和轴8实施方式一起使用。如图示实施方式所示，手柄6包括配合在一起以大致形成手柄6的外部的外部下侧构件59、60和外部上侧构件61、62。电池64、例如锂离子电池可以设置在手柄6的手枪式抓握部分26中。电池64向设置在手柄6的手枪式抓握部分26的上部中的电马达65供电。根据各种实施方式，马达65可以是具有大约25000RPM的最大转速的直流电刷驱动马达。也可以利用其它适当类型的电马达。马达65可以驱动包括第一锥齿轮68和第二锥齿轮70的90°锥齿轮组件66。锥齿轮组件66可以驱动行星齿轮组件72。行星齿轮组件72可以包括连接到传动轴76上的小齿轮74。小齿轮74可以驱动配合的环形齿轮78，环形齿轮78经由传动轴82驱动螺旋齿轮鼓80。环84可以螺纹连接在螺旋齿轮鼓80上。因此，当马达65转动时，环84借助于插入的锥齿轮组件66、行星齿轮组件72和环形齿轮78沿着螺旋齿轮鼓80行进。
手柄6也可以包括与击发扳机20连接的马达运转传感器110(参照图10)，以检测击发扳机20何时已经被操作者朝着手柄6的手枪式抓握部分26向内拉(或者“闭合”)，由此通过端部执行器12致动切割/缝合操作。传感器110可以是比例传感器，例如滑线电阻器或可变电阻器。当击发扳机20被向内拉时，传感器110检测该运动并且发送指示待供应给马达65的电压(或者功率)的电信号。当传感器110是可变电阻器等时，马达65的转动可以与击发扳机20的运动量基本成比例。即，如果操作者仅拉动或闭合击发扳机20很小的量，那么马达65的转速相对较小。当击发扳机20被充分向内拉(或者处于完全闭合位置)时，马达65以最大速度转动。换句话说，使用者越用力拉动击发扳机20，供应给马达65的电压越多，使得转动速率更大。
手柄6可以包括靠近击发扳机20的上部的手柄中间件104。手柄6还可以包括连接在手柄中间件104和击发扳机20上的柱子之间的偏置弹簧112。偏置弹簧112可以使击发扳机20偏向于其完全打开位置。这样，当操作者释放击发扳机20时，偏置弹簧112将击发扳机20拉动到其打开位置，由此解除对传感器110的致动，从而使马达65停止转动。此外，借助于偏置弹簧112，使用者在任何时间闭合击发扳机20，使用者将经受对闭合操作的阻碍，由此向使用者提供关于由马达65施加的旋转量的反馈。此外，操作者可以停止缩回击发扳机20，由此从传感器110移除力，进而使马达65停止。这样，使用者可以停止端部执行器12的展开，由此向操作者提供切割/紧固操作控制的测量。
螺旋齿轮鼓80的远端包括用于驱动环形齿轮122的远侧传动轴120，环形齿轮122与小齿轮124配合。小齿轮124连接到主传动轴组件的主传动轴48上。这样，马达65的转动使得主传动轴组件转动，这使得端部执行器12致动，如上所述。
螺纹连接在螺旋齿轮鼓80上的环84可以包括设置在开槽臂90的槽88中的柱子86。开槽臂90在其相对端94具有开口92，开口92接收连接在手柄外部侧构件59、60之间的枢销96。枢销96也穿过击发扳机20中的开口100和手柄中间件104中的开口102设置。
另外，手柄6可以包括马达反向(或者行程结束)传感器130和马达止动(或者行程开始)传感器142。在各种实施方式中，马达反向传感器130可以是位于螺旋齿轮鼓80的远端处的限位开关，使得螺纹连接在螺旋齿轮鼓80上的环84在环84到达螺旋齿轮鼓80的远端时接触并使马达反向传感器130跳闸。马达反向传感器130在被致动时向马达65发送信号以使其转动方向反向，由此在切割操作后收回端部执行器12的刀32。
马达止动传感器142例如可以是常闭限位开关。在各种实施方式中，其可以位于螺旋齿轮鼓80的近端处，使得环84在其到达螺旋齿轮鼓80的近端时使开关142跳闸。
在操作中，当器械10的操作者向回拉动击发扳机20时，传感器110检测击发扳机20的展开并且向马达65发送信号以使马达65例如以与操作者向回拉动击发扳机20的程度成比例的速率正向转动。马达65的正向转动又使位于行星齿轮组件72的远端处的环形齿轮78转动，由此使螺旋齿轮鼓80转动，使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的转动也驱动上述主传动轴组件，这又使刀32在端部执行器12中展开。即，使刀32和滑架33沿纵向穿过通道22，由此切割夹钳在端部执行器12中的组织。同样，在使用缝合类型的端部执行器的实施方式中，引起端部执行器12的缝合操作。
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已经到达螺旋齿轮鼓80的远端，由此使马达反向传感器130跳闸，这向马达65发送信号以使马达65的转动反向。这又使刀32缩回，并且也使螺旋齿轮鼓80上的环84向回运动到螺旋齿轮鼓80的近端。
手柄中间件104包括如图8和9最好地示出的与开槽臂90接合的背侧肩部106。手柄中间件104也具有与击发扳机20接合的正向运动止动部107。开槽臂90的运动通过马达65的转动如上所述得到控制。当开槽臂90随着环84从螺旋齿轮鼓80的近端行进到远端逆时针旋转时，手柄中间件104将自由逆时针旋转。因此，随着使用者向内拉动击发扳机20，击发扳机20将接合手柄中间件104的正向运动止动件107，使得手柄中间件104逆时针转动。然而，由于背侧肩部106与开槽臂90接合，手柄中间件104仅能够逆时针转动开槽臂90所允许的程度。这样，如果马达65基于一些原因应当停止转动，那么开槽臂90将停止转动，并且由于手柄中间件104因为开槽臂90不会自由逆时针转动，因此使用者不能进一步向内拉动击发扳机20。
图10A和10B示出了可以用作根据本发明的各种实施方式的马达运转传感器110的可变传感器的两种状态。传感器110可以包括表面部分280、第一电极(A)282、第二电极(B)284和位于电极282、284之间的可压缩电介质材料286，例如电活性聚合物(EAP)。传感器110可以被定位成使得表面部分280接触缩回时的击发扳机20。因此，当击发扳机20缩回时，电介质材料286被压缩，如图10B所示，使得电极282、284更近地靠在一起。由于电极282、284之间的距离“b”与电极282、284之间的阻抗直接相关，因此距离越大，阻抗越大，并且距离越近，阻抗越小。这样，电介质材料286由于击发扳机20的缩回被压缩的量(在图42中表示为力“F”)与电极282、284之间的阻抗成比例，其可以用于成比例地控制马达65。
图7至10还示出了用于通过使闭合扳机18缩回而闭合(或夹钳)端部执行器12的砧座24的示例性闭合系统的部件。在所示实施方式中，闭合系统包括通过枢销251连接到闭合扳机18的轭形件250，枢销251穿过闭合扳机18和轭形件250中的对准开口插入。枢销252穿过闭合扳机18中的另一个开口插入，该开口与销251穿过闭合扳机18插入的位置偏离，闭合扳机18围绕枢销252枢转。因此，闭合扳机18的缩回使得闭合扳机18的上部逆时针转动，轭形件250经由销251连接到闭合扳机18的上部。轭形件250的远端经由销254连接到第一闭合支架256上。第一闭合支架256连接到第二闭合支架258。闭合支架256、258共同限定开口，近侧闭合管40的近端(参见图4)被安置并保持在该开口中，使得闭合支架256、258的纵向运动导致近侧闭合管40的纵向运动。器械10还包括设置在近侧闭合管40内侧的闭合杆260。闭合杆260可以包括窗口261，位于手柄外部件的一个(例如在所示实施方式中的外部下侧构件59)上的柱子263设置在窗口261中，以将闭合杆260固定地连接到手柄6。这样，近侧闭合管40能够相对于闭合杆260沿纵向运动。闭合杆260也可以包括远侧轴环267，该远侧轴环267配合在近侧脊管46中的腔269内并且被帽271固定在其中(参见图4)。
在操作中，当轭形件250由于闭合扳机18的缩回而转动时，闭合支架256、258使得近侧闭合管40向远侧运动(即，远离器械10的手柄端)，这导致远侧闭合管42向远侧运动，又导致砧座24围绕枢销25转动到夹钳位置或闭合位置。当闭合扳机18从锁定位置被解锁时，使得近侧闭合管40向近侧滑动，这使远侧闭合管42向近侧滑动，又借助插入在远侧闭合管42的窗口45中的翼片27使得砧座24围绕枢销25枢转到打开或未夹钳位置。这样，通过缩回和锁定闭合扳机18，操作者可以夹钳砧座24和通道22之间的组织，并且可以在切割/缝合操作之后通过将闭合扳机20从锁定位置解锁来放开组织。
图11是根据本发明的各种实施方式的器械10的电路的示意图。当操作者在锁定闭合扳机18之后初始地向内拉动击发扳机20时，传感器110被致动，允许电流流过。如果常开马达反向传感器开关130打开(意味着未到达端部执行器行程的末端)，电流将流向单极双投继电器132。由于马达反向传感器开关130未关闭，因此继电器132的感应器134将不被供应能量，使得继电器132处于其未供能状态。电路也包括钉仓闭锁传感器136。如果端部执行器12包括钉仓34，传感器136处于闭合状态，允许电流流动。否则，如果端部执行器12不包括钉仓34，那么传感器136将打开，由此阻止电池64向马达65供电。
当设有钉仓34时，传感器136闭合，这向单极单投继电器138供能。当继电器138被供以能量时，电流流经继电器136、流经可变电阻器传感器110，并经由双极双投继电器140流向马达65，由此向马达65供电并允许马达65沿正向方向转动。
当端部执行器12到达其行程的末端时，马达反向传感器130被致动，由此闭合开关130并向继电器134供能。这使得继电器134呈现其被供能状态(图13中未示出)，这使得电流绕过仓闭锁传感器136和可变电阻器110，而代之以使得电流流向常闭的双极双投继电器142并经由继电器140但以使得马达65的转动方向反向的方式流回马达65。
由于马达止动传感器开关142是常闭的，电流将流回继电器134以保持其闭合直到开关142打开。当刀32被完全缩回时，马达止动传感器开关142被致动，使得开关142打开，由此从马达65移走功率。
在其他实施方式中，替代比例类型的传感器110，可以使用开关类型的传感器。在这种实施方式中，马达65的转动速率不与操作者施加的力成比例。而是，马达65以大致恒定的速率转动。但是，由于击发扳机20连接到齿轮传动系，因此操作者仍然可体验力反馈。
图12是根据另一种实施方式的动力辅助马达驱动的内切割器的手柄6的侧视图。图12的实施方式除了没有连接到螺纹连接在螺旋齿轮鼓80上的环84上的开槽臂之外，其余类似于图7至10的实施方式。替代地，在图12的实施方式中，环84包括随着环84在螺旋齿轮鼓80上行进(和返回)时与环84一起运动的传感器部分114。传感器部分114包括凹口116。马达反向传感器130可以位于凹口116的远端处并且马达止动传感器142可以位于凹口116的近端处。随着环84在螺旋齿轮鼓80上运动(和返回)，传感器部分114与其一起运动。此外，如图12中所示，中间件104可以具有延伸到凹口116中的臂118。
在操作中，随着器械10的操作者朝着手枪式握把26缩回击发扳机20时，马达运转传感器110检测该运动并且发送信号以向马达65供电，这使得螺旋齿轮鼓80旋转(还有别的动作)。随着螺旋齿轮鼓80旋转，螺纹连接在螺旋齿轮鼓80上的环84行进(或者缩回，这依赖于旋转)。同样，由于击发扳机20被向内拉动，使得中间件104由于接合击发扳机20的正向运动止动部107而与击发扳机20一起逆时针转动。中间件104的逆时针旋转使臂118与环84的传感器部分114一起逆时针旋转，使得臂118保持设置在凹口116中。当环84到达螺旋齿轮鼓80的远端时，臂118将接触并由此使马达反向传感器130跳闸。类似地，当环84到达螺旋齿轮鼓80的近端时，臂将接触并由此使马达止动传感器142跳闸。这些动作可以分别如上所述地使马达65反向和止动。
图13是根据另一种实施方式的动力辅助马达驱动的内切割器的手柄6的侧视图。图13的实施方式除了在臂90中没有开槽之外，其余与图7至10的实施方式类似。替代地，螺纹连接在螺旋齿轮鼓80上的环84包括竖直通道126。替代槽，臂90包括设置在通道126中的柱子128。随着螺旋齿轮鼓80旋转，螺纹连接在螺旋齿轮鼓80上的环84行进(或者缩回，这依赖于旋转)。臂90由于设置在通道126中的柱子128而随着环84行进逆时针旋转，如图13所示。
如上所述，在利用二行程马达驱动的器械时，操作者首先向回拉动并锁定闭合扳机18。图14和15示出了将闭合扳机18锁定到手柄6的手枪式握把部分26的方式的一种实施方式。在图示的实施方式中，手枪式握把部分26包括钩形件150，该钩形件150在扭转弹簧152作用下偏向于围绕枢转点151逆时针旋转。同样，闭合扳机18包括闭合杆154。随着操作者向内拉动闭合扳机18，闭合杆154接合钩形件150的倾斜部分156，由此使钩形件150向上旋转(或者如图14至15中的顺时针方向)，直到闭合杆154完全通过倾斜部分156并进入钩形件150的凹陷式凹口158中，这将闭合扳机18锁定就位。操作者可以通过按下手枪式握把部分26的后侧或相对侧上的滑动释放按钮160来释放闭合扳机18。按下滑动释放按钮160使钩形件150顺时针旋转，由此使闭合杆154从凹陷式凹口158释放。
图16示出了根据各种实施方式的另一种闭合扳机锁定机构。在图16的实施方式中，闭合扳机18包括具有箭头部分161的楔形件160。箭头部分161由弹簧片162向下(或者顺时针方向)偏。楔形件160和弹簧片162例如可以由模制的塑料制成。当闭合扳机18缩回时，箭头部分161穿过手柄6的手枪式握把部分26中的开口164插入。箭头部分161的下倾斜表面166接合开口164的下侧壁168，迫使箭头部分161逆时针旋转。下倾斜表面166最终完全通过下侧壁168，移除箭头部分161上的逆时针力，使得下侧壁168滑入箭头部分161后面的凹口170中的锁定位置。
为了对闭合扳机18进行解锁，使用者按下闭合扳机18的相对侧上的按钮172，使箭头部分161逆时针旋转并且允许箭头部分161从开口164中滑出。
图17至22示出了根据另一种实施方式的闭合扳机锁定机构。如该实施方式所示，闭合扳机18包括柔性的纵向臂176，该纵向臂176包括从其延伸的横销178。臂176和销178例如可以由模制的塑料制成。手柄6的手枪式握把部分26包括开口180，该开口180内设置有横向延伸的楔形件182。当闭合扳机18缩回时，销178接合楔形件182，并且销178被楔形件182的下表面184强迫向下(即，臂176顺时针转动)，如图17和18所示。当销178完全通过下表面184时，臂176上的顺时针力被移除，并且销178逆时针转动，使得销178进入楔形件182后面的凹口186中，如图19所示，由此锁定闭合扳机18。销178由从楔形件184延伸的柔性止动件188进一步保持就位在锁定位置。
为了对闭合扳机18进行解锁，操作者可以进一步挤压闭合扳机18，使销178接合开口180的倾斜后壁190，迫使销178向上通过柔性止动件188，如图20和21所示。之后，销178自由移出开口180中的上通道192，使得闭合扳机18不再锁定到手枪式握把部分26，如图22所示。
图23A-B示出了万向接头(“U形接头”)195。U形接头195的第二件195-2在水平面内旋转，第一件195-1位于该水平面内。图23A示出了处于线性(180°)定向的U形接头195，图23B示出了处于大约150°定向的U形接头195。U形接头195可以替代位于主传动轴组件的关节运动位置14处的锥齿轮52a-c(例如参见图4)使用，以使端部执行器12关节运动。图24A-B示出了可以替代锥齿轮52a-c和U形接头195使用以实现端部执行器12的关节运动的扭转缆线197。
图25至31示出了根据本发明的另一种实施方式的具有动力辅助的马达驱动的二行程外科切割和紧固器械10的另一种实施方式。图25至31中的实施方式类似于图6至10中的实施方式，除了替代图6至10中的螺旋齿轮鼓80，图23至28中的实施方式包括可供选择的齿轮传动组件。图25至31的实施方式包括齿轮箱组件200，该齿轮箱组件200包括设置在机架201中的多个齿轮，其中，齿轮连接在位于传动轴48的近端处的行星齿轮72和小齿轮124之间。如以下进一步说明的，齿轮箱组件200经由击发扳机20向使用者提供有关端部执行器20的展开和载荷力的反馈。同样，使用者可以经由齿轮箱组件200向系统提供动力，以辅助端部执行器12展开。在这个意义上，类似于上述实施方式，图23至32的实施方式是另一种动力辅助马达驱动的器械10，该器械10向使用者提供有关器械所承受的载荷力的反馈。
在图示的实施方式中，击发扳机20包括两个构件：主体部分202和加强部分204。主体部分202例如可以由塑料制成，加强部分204可以由更具刚性的材料例如金属制成。在图示的实施方式中，加强部分204位于主体部分202附近，但根据其他实施方式，加强部分204可以设置在主体部分202内侧。枢销207可以穿过击发扳机构件202、204中的开口插入，并且击发扳机20可以围绕该枢销207旋转。另外，弹簧222可以使击发扳机20偏向于沿逆时针方向旋转。弹簧222可以具有连接到销224的远端，该销224连接到击发扳机20的构件202、204。弹簧222的近端可以连接到手柄外部下侧构件59、60中的一个上。
在图示的实施方式中，主体部分202和加强部分204包括(分别)位于它们的上端部分处的齿轮部分206、208。齿轮部分206、208与齿轮箱组件200中的齿轮接合，如下说明的，以驱动主传动轴组件并且向使用者提供有关端部执行器12展开的反馈。
在图示的实施方式中，齿轮箱组件200可以如图所示包括六个齿轮。齿轮箱组件200的第一齿轮210与击发扳机20的齿轮部分206、208接合。另外，第一齿轮210与较小的第二齿轮212接合，较小的第二齿轮212与大的第三齿轮214同轴。第三齿轮214与较小的第四齿轮216接合，较小的第四齿轮与第五齿轮218同轴。第五齿轮218是90°锥齿轮，该锥齿轮与配合的90°锥齿轮220(图31中最好地示出)接合，该配合的90°锥齿轮220连接到驱动主传动轴48的小齿轮124。
在操作中，当使用者缩回击发扳机20时，马达运转传感器(未示出)被致动，这可以向马达65提供信号使其以与操作者缩回击发扳机20的程度或利用的力成比例的速率转动。这使得马达65以与来自传感器的信号成比例的速度转动。在该实施方式中未示出传感器，但其可以类似于上述的马达运转传感器110。传感器可以位于手柄6中，使得当击发扳机20缩回时传感器被压下。同样，替代比例类型的传感器，可以利用开关式传感器。
马达65的旋转致使锥齿轮68、70旋转，这使得行星齿轮72旋转，又经由传动轴76使得环形齿轮122旋转。环形齿轮122与连接到主传动轴48的小齿轮124啮合。因此，小齿轮124的旋转驱动主传动轴48，这使得端部执行器12的切割/缝合操作被致动。
小齿轮124的正向旋转又使得锥齿轮220转动，这经由齿轮箱组件200的剩余齿轮致使第一齿轮210旋转。第一齿轮210与击发扳机20的齿轮部分206、208接合，由此当马达65为端部执行器12提供正向驱动时使得击发扳机20逆时针旋转(并且当马达65反向旋转以缩回端部执行器12时使得击发扳机20逆时针旋转)。这样，使用者通过抓持在击发扳机20上而体验到有关端部执行器12的载荷力和展开的反馈。因此，当使用者缩回击发扳机20时，操作者将体验有关端部执行器12所受载荷力的阻力。类似地，当操作者在切割/缝合操作之后释放击发扳机20使其能够返回到其初始位置时，使用者将体验来自击发扳机20的与马达65的反向转速大致成比例的顺时针旋转力。
在该实施方式中还应当注意到，使用者可以通过缩回击发扳机20施加力(替代来自马达65的力或者除了来自马达65的力之外的力)以致动主传动轴组件(并由此致动端部执行器12的切割/缝合操作)。即，缩回击发扳机20使得齿轮部分206、208逆时针旋转，这使得齿轮箱组件200的齿轮旋转，由此使得小齿轮124旋转，这又使得主传动轴48旋转。
虽然在图25至31中未示出，器械10还可以包括马达反向传感器和马达止动传感器。如上所述，马达反向传感器和马达止动传感器可以分别检测切割行程结束(刀32完全展开)和缩回操作结束(刀32完全缩回)。与上述结合图11描述的电路类似的电路可以用于适当地向马达65供电。
图32至36示出了根据另一种实施方式的具有动力辅助的二行程、马达驱动的外科切割和紧固器械10。图32至36的实施方式类似于图25至31的实施方式，除了在图32至36的实施方式中，击发扳机20包括下部部分228和上部部分230。部分228和230都连接到穿过每个部分228、230设置的枢销207并且围绕该枢销207枢转。上部部分230包括与齿轮箱组件200的第一齿轮210接合的齿轮部分232。弹簧222连接到上部部分230，使得上部部分偏向于沿着顺时针方向旋转。上部部分230还可以包括与击发扳机20的下部部分228的上表面接触的下臂234，使得当上部部分230顺时针旋转时，下部部分228也顺时针旋转，并且当下部部分228逆时针旋转时，上部部分230也逆时针旋转。类似地，下部部分228包括与上部部分230的肩部接合的旋转止动部238。这样，当上部部分230逆时针旋转时，下部部分228也逆时针旋转，并且当下部部分228顺时针旋转时，上部部分230也顺时针旋转。
图示的实施方式还包括马达运转传感器110，在各种实施方式中，该马达运转传感器110向马达65传输信号，这可以使得马达65以与操作者在缩回击发扳机20时施加的力成比例的速度旋转。传感器110例如可以是如这里说明的滑线电阻器或一些其它可变电阻传感器。另外，器械10可以包括马达反向传感器130，该马达反向传感器130在接触击发扳机20的上部部分230的前表面242时跳闸或换接。马达反向传感器130在被致动时向马达65发送信号以使其反向。器械10还可以包括马达止动传感器142，该马达止动传感器142在接触击发扳机20的下部部分228时跳闸或致动。当马达止动传感器142致动时，其发送信号以使马达65的反向旋转停止。
在操作中，当操作者将闭合扳机18缩回到锁定位置时，击发扳机20(通过现有技术中已知的机构，包括Frederick Shelton，IV等的美国专利No.6978921和Jeffery S.Swayze等的美国专利No.6905057，所述美国专利的全部内容通过引用合并在此)稍稍缩回，使得使用者能够抓紧击发扳机20以便开始切割/缝合操作，如图32和33所示。此时，如图33所示，击发扳机20的上部部分230的齿轮部分232运动到与齿轮箱组件200的第一齿轮210接合。根据各种实施方式，当操作者缩回击发扳机20时，击发扳机20可以在马达运转传感器110跳闸之前转动很小的量，例如转动5度，如图34所示。传感器110的致动使得马达65以与操作者施加的缩回力成比例的速率正向旋转。马达65的正向旋转如上所述使得主传动轴48旋转，这使得端部执行器12中的刀32展开(即，开始穿过通道22)。连接到主传动轴48的小齿轮124的旋转使得齿轮箱组件200中的齿轮210-220旋转。由于第一齿轮210与击发扳机20的上部部分230的齿轮部分232接合，因此上部部分232逆时针旋转，这使得下部部分228也逆时针旋转。
当刀32完全展开(即，在切割行程结束处)时，上部部分230的前表面242使马达反向传感器130跳闸，这向马达65发送信号以使旋转方向反向。这使得主传动轴组件将旋转方向反向以缩回刀32。主传动轴组件的反向旋转也使得齿轮箱组件中的齿轮210-220反向，这使得击发扳机20的上部部分230顺时针旋转，从而使得击发扳机20的下部部分228顺时针旋转，直到当刀32完全缩回时下部部分228使马达止动传感器142跳闸或止动，这使得马达65停止。这样，使用者通过抓持在击发扳机20上感受有关端部执行器12展开的反馈。因此，当使用者缩回击发扳机20时，操作者将感受有关端部执行器12展开的阻力，并且具体地，感受有关刀32所承受的载荷力的阻力。类似地，当操作者在切割/缝合操作之后释放击发扳机20使其能够返回到其初始位置时，使用者将感受来自击发扳机20的与马达65的反向转速大致成比例的顺时针旋转力。
在该实施方式中还应当注意到，使用者可以通过缩回击发扳机20施加力(替代来自马达65的力或者除了来自马达65的力之外的力)以致动主传动轴组件(并由此致动端部执行器12的切割/缝合操作)。即，缩回击发扳机20使得上部部分230的齿轮部分232逆时针旋转，这使得齿轮箱组件200的齿轮旋转，由此使得小齿轮124旋转，这又使得主传动轴组件旋转。
上述实施方式采用具有或不具有用于二行程马达驱动的外科切割和紧固器械的适应控制(例如使用马达65、齿轮传动系和端部执行器12的闭环系统外部的传感器110、130和142)的动力辅助的使用者反馈系统。即，使用者在缩回击发扳机20时施加的力可以借助于(直接或间接)齿轮连接到位于马达65和主传动轴48之间的齿轮传动系的击发扳机20而添加到由马达65施加的力上。在本发明的其它实施方式中，可以为使用者提供有关刀32在端部执行器中的位置的触觉反馈，且不需要击发扳机20齿轮连接到齿轮传动系。图37至40示出了具有这种触觉位置反馈系统的马达驱动的外科切割和紧固器械。
在图37至40的图示实施方式中，类似于图32至36中示出的器械10，击发扳机20可以具有下部部分228和上部部分230。但与图32至36的实施方式不同，上部部分230没有与齿轮传动系部分配合的齿轮部分。替代地，器械包括第二马达265，该第二马达265中螺纹连接有螺纹杆266。螺纹杆266随着马达265旋转而纵向地往复运动出入马达265，往复运动方向依赖于旋转方向。器械10还包括响应于主传动轴48的旋转的编码器268，该编码器268例如用于将主传动轴48(或者主传动组件的其它部件)的增量角运动转换成相应序列的数字信号。在图示的实施方式中，小齿轮124包括连接到编码器268的近侧传动轴270。
器械10还包括控制电路(未示出)，该控制电路可以使用接收来自编码器268的数字信号的微控制器或一些其它类型的集成电路来执行。基于来自编码器268的信号，控制电路可以计算刀32在端部执行器12中展开的阶段。即，控制电路能够计算刀32是否完全展开、完全缩回或处于中间阶段。基于对端部执行器12的展开阶段的计算，控制电路可以向第二马达265发送信号以控制其旋转，由此控制螺纹杆266的往复运动。
在操作中，如图37所示，当闭合扳机18未锁定在夹钳位置时，击发扳机20远离手柄6的手枪式握把部分26旋转，使得击发扳机20的上部部分230的前表面242不与螺纹杆266的近端接触。当操作者缩回闭合扳机18并将其锁定在夹钳位置时，击发扳机20朝向闭合扳机18稍稍旋转，使得操作者能够抓紧击发扳机20，如图38所示。在该位置，上部部分230的前表面242接触螺纹杆266的近端。
然后，随着使用者缩回击发扳机20，在初始旋转量(例如旋转5度)之后，马达运转传感器110可以被激活，使得如上所述传感器110向马达65发送信号以使马达以与操作者向击发扳机20施加的缩回力大小成比例的正向速度旋转。马达65的正向旋转使得主传动轴48经由齿轮传动系旋转，这使得刀32和滑架33沿着通道22行进并且切断被夹钳在端部执行器12中的组织。控制电路接收来自编码器268的有关主传动轴组件的增量旋转的输出信号并且向第二马达265发送信号以使第二马达265旋转，这使得螺纹杆266缩回到马达265中。这允许击发扳机20的上部部分230逆时针旋转，从而允许击发扳机的下部部分238也逆时针旋转。这样，由于螺纹杆266的往复运动涉及主传动轴组件的旋转，器械10的操作者由于抓持击发扳机20而感受有关端部执行器12的位置的触觉反馈。但是，由于在该实施方式中击发扳机20未齿轮连接到齿轮传动系，因此由操作者施加的缩回力不直接地影响主传动轴组件的传动。
通过经由来自编码器268的输出信号追踪主传动轴组件的增量旋转，控制电路能够计算刀32何时完全展开(即，完全伸展)。此时，控制电路可以向马达65发送信号以使其反向，从而使刀32缩回。马达65的反向使得主传动轴组件的旋转方向反向，这也是由编码器268来检测。基于由编码器268检测的反向旋转，控制电路向第二马达265发送信号以使其将旋转方向反向，使得螺纹杆266开始从马达265沿纵向延伸。该运动使击发扳机20的上部部分230顺时针旋转，这使得下部部分228顺时针旋转。这样，操作者可能感受来自击发扳机20的顺时针力，这向操作者提供有关刀32在端部执行器12中的缩回位置的反馈。控制电路可以确定刀32何时完全缩回。此时，控制电路可以向马达65发送信号以使其停止旋转。
根据其它实施方式，除了利用控制电路来确定刀32的位置外，如上所述可以利用马达反向传感器和马达止动传感器。另外，除了使用比例传感器110来控制马达65的旋转外，可以利用双位开关或传感器。在这种实施方式中，操作者不能控制马达65的旋转速率。而是，其可以预编程的速率旋转。
图41至43示出了机械致动的内切割器、并且特别地是其手柄6、轴8和端部执行器12的示例性实施方式。序列号为No.11/052632、题为“Surgical Stapling Instrument Incorporating A Multi-Stroke FiringMechanism With Automatic End Of Firing Travel Retraction”的美国专利申请中非常详细地描述了机械致动的内部切割器，该美国专利申请的全部内容通过引用合并在此。参照图41，端部执行器12首先通过包括连接到砧座近端1004的砧座面1002来响应于来自手柄6的闭合运动(未在图41中描述)，该砧座近端1004包括横向突出的砧座枢销25，砧座枢销25位于竖直突出的砧座翼片27的近侧。砧座枢销25在钉仓通道22中的肾脏形开口1006内移动，以相对于通道22打开和闭合砧座24。翼片27接合向内延伸到位于闭合管1005的远端1008上的翼片开口45中的弯曲翼片1007，弯曲翼片1007在远侧终止于推抵砧座面1002的远侧边缘1008。因此，当闭合管1005从其打开位置向近侧运动时，闭合管1005的弯曲翼片1007向近侧拉动砧座翼片27，并且砧座枢销25沿着钉仓通道22的腰形开口1006行进，使得砧座24同时向近侧移动和向上旋转到打开位置。当闭合管1005向远侧移动时，翼片开口45中的弯曲翼片1007从砧座翼片27释放并且远侧边缘1008推动砧座面1002，闭合砧座24。
继续参照图41，轴8和端部执行器12也包括响应击发杆1010的击发运动的部件。具体地，击发杆1010可旋转地接合具有纵向凹陷1014的击发沟槽构件1012。击发沟槽构件1012直接响应于击发杆1010的纵向运动而在机架1016内纵向运动。闭合管1005内的纵向槽1018与手柄6的外部右侧和左侧手柄构件61、62可操作地连接(图41中未示出)。闭合管1005中的纵向槽1018足够长，以允许手柄构件61、62相对纵向运动，从而通过连接穿过机架1016中的纵向槽1020以可滑动地接合机架沟槽构件1012中的纵向凹陷1014的手柄构件61、62来分别实现击发和闭合运动。
机架沟槽构件1012的远端连接到击发杆1022的近端，击发杆在机架1016内、特别地在机架中的引导件1024内运动，以使刀32向远侧突出到端部执行器12中。端部执行器12包括由刀32致动的钉仓34。钉仓34具有保持钉仓主体1030、楔形滑架驱动器33、缝钉驱动器1034和缝钉1036的盘1028。可以理解，楔形滑架驱动器33在位于钉仓盘1028和钉仓主体1030之间的击发凹陷(未示出)内纵向运动。楔形滑架驱动器33具有接触并向上提升缝钉驱动器1034驱动缝钉1036的凸轮表面。钉仓主体1030还包括用于刀32通过的向近侧打开的竖直槽1031。特别地，切割表面1027沿着刀32的远端设置以在组织被缝合之后切割组织。
应当理解，轴8在图4中被示出为非关节运动轴。但是，本发明申请可以包括例如像上述参照图1至4所示以及在以下美国专利和专利申请中描述的能够关节运动的器械，这些美国专利和专利申请的全部内容通过引用合并在此：(1)Frederick E.Shelton IV，BrianJ.Hemmelgarn，Jeffrey S.Swayze，Kenneth S.Wales的于2003年7月9日提交的题为“SRUGICAL INSTRUMENT INCORPORATING ANARTICULATION MECHANISM HAVING ROTATION ABOUT THELONGITUDINAL AXIS”的美国专利申请公开文献No.2005/0006434；(2)Brian J.Hemmelgarn的题为“SURGICAL STAPLINGINSTRUMENT INCORPORATING AN ARTICULATION JOINT FORA FIRING BAR TRACK”的美国专利No.6786382；(3)Jeffrey S.Swayze的题为“A SURGICAL INSTRUMENT WITH ALATERAL-MOVING ARTICULATION CONTROL”的美国专利No.6981628；(4)Frederick E.Shelton IV，Michael Setser，BruceWeisenburgn II的题为“SURGICAL STAPLING INSTRUMENTINCORPORATING A TAPERED FIRING BAR FOR INCREASEDFLEXIBILITY AROUND THE ARTICULATION JOINT”的美国专利No.6964363；以及(5)Jeffrey S.Swayze，Joseph Charles Hueil于2003年7月9日提交的题为“SURGICAL STAPLING INSTRUMENTHAVING ARTICULATIN JOINT SUPPORT PLATES FORSUPPORTING A FIRING BAR”的美国专利申请公开文献No.2005/0006431。
图42至43示出了能够用在机械致动的内切割器的手柄6的实施方式以及如上述图41中所示的轴8和端部执行器12的实施方式。可以理解的是，可以利用任何适当的手柄设计以机械地闭合和击发端部执行器12。在图42至43中，外科缝合和切割器械10的手柄6包括提供例如增强的强度、减小的手柄尺寸、最小化的束缚等特征的链接传输击发机构1060。
通过朝向手柄6的手枪式握把26按压闭合扳机18致使端部执行器12闭合(图42至43中未示出)。闭合扳机18围绕连接到手柄6的外部右和左下侧构件59、60的闭合枢销252枢转，使得闭合扳机18的上部部分1094向前运动。闭合管1005经由闭合轭形件250接收该闭合运动，该闭合轭形件250分别通过闭合轭形件销1044和闭合连接销1046销接到闭合连接件1042和闭合扳机18的上部部分1094上。
在图42的完全打开位置，闭合扳机18的上部部分1094接触枢转闭合释放按钮30的锁定臂1048并将其保持在所示位置。当闭合扳机18到达其完全压下位置时，闭合扳机18释放锁定臂1048并且抵接表面1050旋转到与枢转锁定臂1048的远侧右凹口1052接合，将闭合扳机18保持在夹钳或闭合位置。锁定臂1048的近端与构件59、60围绕横向枢转连接件1054枢转，以暴露闭合释放按钮30。闭合释放按钮30的中间远侧1056被压缩弹簧1058驱向近侧，该压缩弹簧1058被压缩在外壳结构1040和闭合释放按钮30之间。结果是闭合释放按钮30将锁定臂1048逆时针(当从左侧观察时)驱向与闭合扳机18的抵接表面1050锁定接触，这防止当链接传输击发系统1040处于未缩回状况时闭合扳机18松开。
在闭合扳机18缩回并且完全压下时，击发扳机20未锁定并且可以朝向手枪式握把26压下(在该实施方式中多次压下)以实现端部执行器12的击发。如图所示，链接传输击发机构1060初始缩回，通过被限制在手柄6的手枪式握把26中的组合拉伸/压缩弹簧1062被促使保持在该位置，其中，该组合拉伸/压缩弹簧1062的非活动端1063连接到构件59、60并且活动端1064连接到钢带1066的向下挠曲且位于近侧的缩回端1067。
钢带1066的设置在远侧的端部1068连接到用于结构载荷的连接件联结器1070，该联结器1070又连接到形成连接齿条1074的多个连接件1072a-1072d的前连接件1072a。连接齿条1074是柔性的又具有形成直的刚性齿条组件的远侧连接件，该刚性齿条组件可以通过轴8中的击发杆1010传递大的击发力，又容易地缩回到手枪式握把26中以使手柄6的纵向长度最小化。应当理解的是，组合拉伸/压缩弹簧1062增加可用击发行程的量，同时经由单个弹簧将最小长度减小一半。
击发扳机20围绕连接到手柄构件59、60上的击发扳机销96枢转。击发扳机20的上部部分228随着击发扳机20被朝向手枪式握把26压下时围绕击发扳机销96向远侧运动，拉伸在近侧设置的击发扳机拉伸弹簧222，弹簧222近侧地连接在击发扳机20的上部部分228和构件59、60之间。击发扳机20的上部部分228在每次击发扳机压下的过程中通过牵引偏置机构1078接合连接齿条1074，该牵引偏压机构1078在击发扳机20被释放时也脱离接合。击发扳机拉伸弹簧222当被释放时向远侧驱动击发扳机20并且与牵引偏压机构1078脱离接合。
当链接传输击发机构1040致动时，空转轮1080通过与连接齿条1074的带齿上表面1082接合而顺时针旋转(如从左侧观察到的)。该旋转耦合到指示器齿轮1084，该指示器齿轮1084由此响应于空转轮1080逆时针旋转。空转轮1080和指示器齿轮1084都可旋转地连接到手柄6的构件59、60。连接齿条1074、空转轮1080和指示器齿轮1084之间的传动关系可以被有利地选择为使得带齿上表面1082具有适当强的齿尺寸以及指示器齿轮1084在链接传输击发机构1060的完全击发行程过程中旋转不多于一转。
如以下更加详细说明的，指示器齿轮1084执行至少四种功能。首先，当连接齿条1074完全缩回并且扳机18、20如图42所示都打开时，指示器齿轮1084的左侧上的圆形脊1088中的开口1086出现在锁定臂1048的上表面1090。锁定臂1048通过与闭合扳机18接触而被偏置在开口1086中，闭合扳机18又由闭合拉伸弹簧1092驱向打开位置。闭合扳机拉伸弹簧1092在近侧连接到闭合扳机18的上部部分1094和手柄构件59、60上，并由此在闭合扳机18的闭合过程中存储能量，该能量将闭合扳机18向远侧驱向其未闭合位置。
指示器齿轮1084的第二功能是与外部设置在手柄6上的指示缩回旋钮1096连接。因此，指示器齿轮1084将击发机构1060的相对位置传送至指示缩回旋钮1096，使得外科医生得到击发扳机20需要多少行程来完成击发的视觉指示。
指示器齿轮1084的第三功能是在外科缝合和切割器械10被操作时使防后传机构(anti-backup mechanism，单向离合器机构)1097的防后传机构释放杆1098沿纵向和角向运动。在击发行程过程中，通过指示器齿轮1084使防后传机构释放杆1098向近侧运动使防后传机构1097能够运动，该防后传机构1097使得击发杆1010向远侧运动并且阻止击发杆1010向近侧运动。该运动也使防后传机构释放按钮1100从手柄构件59、60的近端延伸，以在在击发行程过程中需要缩回链接传输击发机构1060时用于操作者致动。在击发行程完成之后，指示器齿轮1084在击发机构1060缩回时使旋转方向反向。反向的旋转使防后传机构1097不能运动、将防后传机构释放按钮1100收回到手柄6中，并且使防后传机构释放杆1098横向旋转到右侧以使指示器齿轮1084继续反向旋转。
指示器齿轮1084的第四功能是接收来自指示缩回旋钮1096的人工旋转(在图42中描述为顺时针)，以在防后传机构1097未锁定的情况下缩回击发机构1060，由此克服击发机构1060中的任何束缚，这通过组合拉伸/压缩弹簧1062是不能轻易克服的。可以在击发机构1060部分击发之后实施该人工缩回辅助，否则人工缩回辅助会由防后传机构1097阻止，该防后传机构1097收回防后传机构释放按钮1100，使得防后传机构释放按钮1100不会使防后传机构释放杆1098沿横向运动。
继续参照图42至43，防后传机构1097包括近端可操作地连接在防后传机构释放按钮1100以及远端可操作地连接到防后传机构轭形件1102的可由操作者接近的防后传机构释放杆1098。具体地，防后传机构释放杆1098的远端1099通过防后传机构轭销1104与防后传机构轭形件1102接合。防后传机构轭形件1102沿纵向运动以向防后传机构凸轮槽管1106施加旋转，该防后传机构凸轮槽管1106由手柄构件50、60纵向地限制并且在击发杆1010与连接齿条1074的连接件联结器1070的连接处的远侧包围击发杆1010。防后传机构轭形件1102将来自防后传机构释放杆1098的纵向运动经由凸轮槽管销1108传送给防后传机构凸轮槽管1106。即，凸轮槽管销1108在防后传机构凸轮槽管1106中的角向槽内的纵向运动使防后传机构槽管1106旋转。
防后传机构压缩弹簧1110、防后传机构板1112和防后传机构凸轮管1114分别被限制在机架1016的近端和防后传机构凸轮槽管1106之间。如所描述的，击发杆1010的近侧运动使得防后传机构板1112从顶部枢转到后部，与击发杆1010接触的摩擦力增加，这阻止击发杆1010进一步向近侧运动。
防后传机构板1112以与纱门锁防后传机构类似的方式枢转，纱门锁在防后传机构凸轮槽管1106非常靠近防后传机构凸轮管1114时保持纱门打开。特别地，防后传机构压缩弹簧1110能够作用在板1112的顶表面上，以使防后传机构板1112斜向其锁定位置。防后传机构凸轮槽管1106的旋转使得防后传机构凸轮管1114作远侧凸轮运动，由此向远侧推动防后传机构板1112的顶部，克服来自防后传机构压缩弹簧1110的力，由此将防后传机构板1112定位在允许击发杆1010向近侧缩回的未倾斜的(垂直的)未锁定位置。
具体参照图43，牵引偏压机构1078被示出为包括爪形件1116，该爪形件1116具有向远侧突出的窄末端1118和位于其近端处的向右突出的横销1120，横销穿过可旋转地插过击发扳机20的上部部分230中的孔1076。在击发扳机20的右侧，横销1120接收偏置构件，被描述为偏置轮1122。随着击发扳机20前后移动，偏置轮1122走过一个靠近手柄6的右半侧构件59的弧形，在其行程的远侧部分处超过一体地形成在右半侧构件59中的偏置倾斜部1124。偏置轮1122可以有利地由弹性摩擦材料形成，所述材料将逆时针旋转(当从左侧观察时)带入爪形件1116的横销1120中，由此使向远侧突出的窄末端1118向下偏的牵引力引入最近的连接件1072a-d的倾斜的中心轨道1075，以接合连接齿条1074。
随着击发扳机20被释放，偏置轮1122因此以牵引的方式使爪形件1116偏向相反的方向，将窄末端1118从连接齿条1074的倾斜的中心轨道1075提升。为了确保末端1118在高载荷状况下以及在爪形件1116的接近全远侧行程处脱离接合，爪形件1116的右侧向上倾斜到闭合轭形件250的右侧上的面向近侧和上方的斜表面1126上，以使窄末端1118从倾斜的中心轨道1075脱离接合。如果击发扳机20在除了全行程之外的任何位置处释放，偏置轮1122用于从倾斜的中心轨道1075处提升窄末端1118。虽然描述了偏置轮1122，但应当理解的是，偏置构件或轮1122的形状是示例性的，并且可以改变以适应利用摩擦或牵引来与端部执行器12的击发接合或脱离接合的各种形状。
外科器械10的各种实施方式具有在使用过程中一次或多次记录器械状况的能力。图44示出了用于记录器械10的状况的系统2000的框图。可以理解，系统2000可以在例如上述参照图1至40描述的具有马达驱动或马达辅助击发的器械10的实施方式中以及在例如上述参照图41至43描述的具有机械致动击发的器械10的实施方式中实施。
系统2000可以包括用于感测器械状况的各种传感器2002、2004、2006、2008、2010、2012。传感器例如可以定位在器械10上或其内。在各种实施方式中，传感器可以是仅向系统2000提供输出的专用传感器，或者可以是执行器械10中的其它功能的双重用途传感器。例如，上述传感器110、130、142也能够向系统2000提供输出。
每个传感器直接地或间接地向存储装置2001提供信号，该存储装置2001如下面更加详细说明的那样记录信号。存储装置2001可以是能够存储或记录传感器信号的任何类型的装置。例如，存储装置2001可以包括微处理器、电可擦除可编程只读存储器(EEPROM)、或任何其它适当的存储装置。存储装置2001可以任何适当的方式记录由传感器提供的信号。例如，在一种实施方式中，存储装置2001可以在来自特定传感器的信号改变状态时记录该信号。在另一种实施方式中，存储装置2001可以在来自任何传感器的信号改变状态时记录系统2000的状态，例如来自系统2000中所包含的所有传感器的信号。这可以提供器械10的状态的快速记录。在各种实施方式中，存储装置2001和/或传感器可以被实施为包括可以从DALLASSEMICONDUCTOR得到的1-WIRE总线产品，例如1-WIREEEPROM。
在各种实施方式中，存储装置2001是可从外部访问的，允许例如计算机等外设装置访问由存储装置2001记录的器械状况。例如，存储装置2001可以包括数据端口2020。数据端口2020可以例如串行或并行格式根据任何有线或无线通信协议提供存储的器械状况。除了输出端口2020之外或者替代输出端口2020，存储装置2001也可以包括可移除介质2021。可移除介质2021可以是能够从器械10移除的任何类型的适当的数据存储装置。例如，可移除介质2021可以包括任何适当类型的闪存，例如个人计算机存储卡国际协会(PCMCIA)卡、COMPACTFLASH卡、MULTIMEDIA卡、FLASHMEDIA卡等。可移除介质2021也可以包括任何适当类型的磁盘存储器，例如包括便携式硬盘驱动器、高密度磁盘(CD)、数字视频光盘(DVD)等。
闭合扳机传感器2002感测闭合扳机18的状况。图45和46示出了闭合扳机传感器2002的示例性的实施方式。在图45和46中，闭合扳机传感器2002定位在闭合扳机18和闭合枢销252之间。可以理解，朝向手枪式握把26拉动闭合扳机18使得闭合扳机18在闭合枢销252上施加力。传感器2002可以感测该力，并且例如如上述参照图10A和10B和传感器110所述的响应于所感测的力产生信号。在各种实施方式中，闭合扳机传感器2002可以是仅指示闭合扳机18是否被致动的数字传感器。在其它各种实施方式中，闭合扳机传感器2002可以是指示施加在闭合扳机18上的力和/或闭合扳机18的位置的模拟传感器。如果闭合扳机传感器2002是模拟传感器，那么模数转换器可以符合逻辑地定位在传感器2002和存储装置2001之间。同样，可以理解，闭合扳机传感器2002可以采用任何适当的形式并且可以设置在允许感测闭合扳机状况的任何适当位置。
砧座闭合传感器2004可以感测砧座24是否闭合。图47示出了示例性的砧座闭合传感器2004。传感器2004如图所示紧挨钉通道22的腰形开口1006定位或者定位在其中。随着砧座24闭合，砧座枢销25滑动通过腰形开口1006并且与传感器2004接触，使得传感器2004产生指示砧座24闭合的信号。传感器2004可以是包括接近度传感器等任何适当类型的数字或模拟传感器。可以理解，当砧座闭合传感器2004是模拟传感器时，模数转换器可以符合逻辑地设置在传感器2004和存储装置2001之间。
所示砧座闭合载荷传感器2006设置在缝钉通道22的内侧下表面上。在使用中，传感器2006可以与钉仓34(图46未示出)底侧相接触。随着砧座24闭合，砧座在钉仓34上施加力，该力被传递到传感器2006。作为响应，传感器2006产生信号。该信号可以是模拟信号，该模拟信号与由于砧座24的闭合由钉仓34作用在传感器2006上的力成比例。参照图44，模拟信号可以被提供到模数转换器2004中，该模数转换器在信号被提供到存储装置2001之前将模拟信号转换成数字信号。可以理解的是，在传感器2006是数字传感器或二进制传感器的实施方式中可不用包括模数转换器2014。
击发扳机传感器110感应击发扳机20的位置和/或状态。在器械的马达驱动的或马达辅助的实施方式中，击发扳机传感器可能双倍于上述马达运转传感器110。另外，击发扳机传感器110可以采用上述的任何形式，可以是模拟的或是数字的。图45和图46示出了击发扳机传感器110的另一种实施方式。在图45和图46中，击发扳机传感器安装在击发扳机20和击发扳机枢销96之间。当击发扳机20被拉动时，它将在击发扳机枢销96上施加力，该力由传感器110感测。参照图44，在击发扳机传感器110的输出是模拟量的实施方式中，模数转换器2016就符合逻辑地被包含在击发扳机传感器110和存储装置2001之间。
刀位置传感器2008感应刀32或切割表面1027在缝钉通道22内的位置。图47和图48示出了刀位置传感器2008的实施方式，这些实施方式适用于图41所示的机械致动的轴8和端部执行器12。该传感器2008包括连接到器械10的击发杆1022的磁铁2009。线圈2011围绕着击发杆1022放置，线圈例如可以沿着击发沟槽构件1012(参照图41)的纵向凹陷1014安装。随着刀32和切割表面1027通过缝钉通道22往复运动，击发杆1022和磁铁2009可以前后移动通过线圈2011。这种相对于线圈的移动在线圈中产生了与击发杆在线圈内的位置和切割边缘1027在缝钉通道22内的位置成比例的电压。这种电压可以例如通过模数转换器2018提供给存储装置2001。
在各种实施方式中，刀位置传感器2008可以由一系列放置在轴8上或轴内的数字传感器(未示出)替代。这些数字传感器可以感测击发杆1022的特征，例如，磁铁2009通过轴8往复运动的特征。击发杆1022在轴8中的位置，并通过引申，刀32在缝钉通道22中的位置可以近似为上次数字传感器运动的位置。
参照图3至6，可以理解的是，刀位置也可以在如上所示的例如具有旋转驱动的端部执行器12和轴8的器械10的实施方式内被感测。编码器例如编码器268，能够产生信号，该信号与螺旋丝杠36或任何其他传动轴或齿轮的转动成比例。由于丝杠36和其他传动轴和齿轮的转动与刀32通过通道22的运动成比例，那么由编码器268产生的信号也与刀32的运动成比例，因此，编码器268的输出可以提供到存储装置2001中。
钉仓存在传感器2010可以感测钉仓34在钉通道22内的存在。在马达驱动的或马达辅助的器械中，钉仓存在传感器2010可以双倍于前面参照图11描述的钉仓闭锁传感器136。图50和51示出了钉仓存在传感器2010的一种实施方式。在该实施方式中，钉仓存在传感器2010包含两个触点2011和2013。当钉仓34不存在的时候，触点2011和2013形成开环电路。当钉仓34存在的时候，钉仓34的钉仓盘1028与触点2011和2013接触，形成闭合电路。当电路开环时，传感器2010输出逻辑0。当电路闭合时，传感器2010输出逻辑1。如图44所示，传感器2010的输出提供给存储装置2001。
钉仓状况传感器2012可以指示安装在缝钉通道22内的钉仓34是否已经被击发或用过。随着刀32移动穿过端部执行器12，刀推动击发钉仓的滑架33。然后刀32往回向它的初始位置移动，将滑架33留在钉仓的远端处。没有滑架33引导刀，刀32会坠入闭锁凹窝2022。传感器2012可以感测刀32是否存在在闭锁凹窝2022中，间接地指示出钉仓34是否被用过。可以理解的是，在各种实施方式中，传感器2012可以直接感测钉仓34近端处是否存在滑架，进而消除刀32坠入闭锁凹窝2022的需要。
图52A和图52B描述了外科器械10的操作实施方式的流程图2200，该外科器械被构造为内切割器并根据各种实施方式具有记录器械状况的能力。在方框2202中，器械10的砧座24关闭。这将导致闭合扳机传感器2002和或砧座闭合传感器2006改变状态。作为响应，在方框2203中，存储装置2001可以记录下系统2000中的所有传感器的状态。在方框2204中，器械10可被插入到患者体内。当器械被插入后，砧座24可在方框2206步骤中被打开并关闭，例如，以操作位于外科手术部位的组织。砧座24的每次打开和关闭都会导致闭合扳机传感器2002和/或砧座闭合传感器2004改变状态。作为响应，在方框2205中，存储装置2001记录下系统2000的状态。
在方框2208中，组织被夹钳以便切割和缝合。如果砧座24在决定框2210处没有闭合，则需要继续夹钳。如果砧座24闭合了，传感器2002、2004和/或2006可能会改变状态，促使存储装置2001在方框2213处记录系统的状态。这种记录可包括自传感器2006接收的闭合压力。在方框2212处，切割和缝钉发生。当击发扳机20向着手枪式握把26拉动时，击发扳机传感器110可改变状态。同样，当刀32通过缝钉通道22移动的时候，刀位置传感器2008将会改变状态。作为响应，在方框2013中，存储装置2001记录下系统2000的状态。
当切割和缝合操作完成时，刀32可以返回至预击发位置。由于钉仓34已经被击发，刀32可坠入到闭锁凹窝2022中，从而改变钉仓状况传感器2012的状态并在方框2015处触发存储装置2001记录系统2000的状态。然后砧座24可以打开以清理组织，这可导致一个或多个闭合扳机传感器2002、砧座闭合传感器2004和砧座闭合载荷传感器2006改变状态，从而导致在方框2017处记录系统2000的状态。在组织被清理完毕后，在方框2220处砧座24可再闭合。这将导致至少传感器2002和2004改变成另一种状态，这又导致在方框2019处存储装置2001记录系统2000的状态。然后在方框2222处器械10可以从患者身上移除。
如果在同样的手术中器械10被再次使用，可在方框2224处砧座打开，在方框2223处触发系统状态的另一次记录。在方框2226处用过的钉仓34可以从端部执行器12处移走。这将导致钉仓存在传感器2010改变状态并在方框2225处导致记录系统状态。在方框2228处，另一个钉仓34被插入，这将导致钉仓存在传感器2010改变状态并在方框2227处导致记录系统状态。如果决定框2230指示该另一个钉仓34是一个新钉仓，它的插入操作可能也会导致钉仓状况传感器2012的状态改变。在这种情况下，在方框2231处系统状态被记录。
图53示出了根据各种实施方式从存储装置2001中得到的示例性的存储图2300。该存储图2300包含有一系列的列2302、2304、2306、2308、2310、2312、2314、2316和行(未标记)。列2302示出了每一行的事件号码。另一列表明了系统2000的一个传感器的输出。在同一事件号码下，所有在给定的时间记录的传感器读数都可以被记录在相同的行里。因此，每一行表明了一种情况，在该情况中，来自系统2000的传感器的一个或多个信号被记录。
列2304列出了在每一个事件中记录的闭合载荷。这可以反映出砧座闭合载荷传感器2006的输出。列2306列出了击发行程位置。这可以从刀位置传感器2008得出。例如，刀32的总行程可以分成部分。列2306列出的数字说明了刀32目前所处的部分。在列2308中列出了击发载荷。这可以从击发扳机传感器110得到。在列2310中列出了刀位置。刀位置可以类似击发行程从刀位置传感器2008得到。砧座24的打开和关闭与否被罗列在列2312中。这个值可以从砧座闭合传感器2004和/或砧座闭合载荷传感器2006的输出得到。列2314示出了滑架33存在与否或钉仓34用过与否。这些值可以通过钉仓状态传感器2012得到的。最后，列2316示出了钉仓34存在与否，这些值可以通过钉仓存在传感器2010得到。可以理解的是，各种其他值可以存储在存储装置2001中，例如，包括通过传感器130、142测量的击发行程的结束和开始。
图54和图55示出了本系统2000的另一种实施方式。图54示出的实施方式与图44示出的实施方式相似，除了在图54中，与控制单元2400通信的传感器2002-2010优选地放置在器械的手柄6内，更优选地放置在手柄6的手枪式握把26内。控制单元2400可以包括处理器2402和存储装置2001。存储装置2001可以包含只读存储单元2404和读写存储单元2406。控制单元2400也包含有用于与传感器2002-2010通信的模数转换器(ADC)和数模转换器(DAC)(未示出)。只读存储单元2404可包含有EPROM和/或闪存EEPROM存储单元。读写存储单元2406可包含有非永久性存储单元例如随机访问存储(RAM)单元。控制单元2400的各种部件可以是分离的或者他们也可以集成在一个或几个部件内。例如，在一种实施方式中，处理器2402、ROM2404、RAM2406、DACs和ADCs可以是微控制器或片上计算机的一部分。
控制单元2400可以通过电源2408供电，比如电池。对于利用DC马达为端部执行器供电的器械10，为控制单元2400供电的电源2408可以是为马达供电的相同电源，或者，不同的电源可用于控制单元2400和马达65。
各种传感器的输出可以数字量的形式存储在存储单元2404、2406的一个或两个内。公布的美国专利申请文献NO.2007-0175964A1公开了一种具有用于存储和记录传感器数据的存储装置的内切割器，其中，该美国专利申请文献的全部内容通过引用合并在此。上文提到的一些传感器的输出也可以是模拟量形式。对于这种类型的传感器，ADCs可以用于将模拟传感器信号转换为数字形式存储在存储单元2404、2406中。同样，传感器也可以通过有线和/或无线通信链路与控制单元2400连接。例如，传感器和控制单元2400可以通过1-WIRE或者I2C总线通信。对于控制单元2400与传感器无线通信的实施方式，传感器可以包含有发射机应答器，该发射机应答器与控制单元2400的收发器(未示出)相通信。
尽管图44未示出，器械10还可以包含有一个或多个感测端部执行器的关节运动状态的关节运动传感器。例如，关节运动传感器可以放置在关节运动枢轴内部或附近并感测端部执行器12和轴8之间的相对关节运动。关节运动传感器也可以与控制单元2400通信，来自关节运动传感器的数据可被存储在控制单元2400的存储装置2001中。2008年5月21日提交的题为“Surgical Instrument WithAutomatically Reconfigurable Articulating End Effector”、序列号为NO.12/124655的美国专利申请提供了有关这种关节运动传感器的更详细的描述，其中该美国专利申请的全部内容通过引用合并在此。另外，这些传感器也可以包括各种马达相关传感器，该种传感器可检测马达65的状况，例如RPM等。
根据各种实施方式，存储在存储装置2001内的数据可以被加密。例如，存储单元2404、2406之一，诸如ROM2404可以存储加密码或者软件，其在由处理器2402执行时使得处理器2402对从传感器接收和存储在存储设备2001中的传感器数据进行加密。
控制单元2400也可以具有输出端口2020，输出端口2020是可由远程计算机装置2420通过与输出端口2020连接的通信链路2422从外部访问的。通信链路2422可以是有线的或者无线的通信链路。例如，输出端口2020可以包含串行数据端口例如USB端口(包括A型、B型、Mini-A、Mini-B USB端口)、IEEE 1394接口(包括IEEE 1394a、1394b和1394c)、RS-232端口、RS-423端口、RS-485端口、光学端口、例如SONET或SDH端口或任何其他用于有线串行数据通信链路2422的适合的串行数据端口。通信链路2422也可以是并行数据通信链路，例如，ISA、ATA、SCSI、PCI。在这种情况下，输出端口2020可以是对应的并行数据输出端口。另外，通信链路2422可以是无线数据链路，例如使用IEEE-802.11标准之一的链路。
远程计算机装置2420可以是带有处理器和存储器的，能够与控制单元2400通信且能够下载存储在存储装置2001内数据的任何装置。例如，远程计算机装置2420可以是一台台式机、笔记本电脑、服务器、工作站、掌上电脑、迷你微机、袖珍计算机等。远程计算机装置2420可以在器械10的外部(即，不是器械10的一部分)而且在向计算机装置2420下载数据的时候，远程计算机可以放置在与器械10相对较近的地方，或者也可以放置在与器械10较远的地方、诸如附近的屋子里面或者甚至更远的地方。
图56示出了根据本发明的各种实施方式的过程的流程图。该过程从步骤2500开始，在此处，临床医生用器械10执行手术步骤。在步骤2502，器械中的各种传感器捕捉数据并将数据传送给控制单元2400。在步骤2504，数据可以通过控制单元2400进行加密，在步骤2506，加密数据被存储在存储单元2001中。在其他的实施方式中，数据不需要加密或者只有一部分需要加密。然后，在步骤2508，在远程计算机装置2420和控制单元2400之间例如通过输出端口2020建立数据链路。然后，在步骤2510，来自传感器的存储在存储单元2001内的数据的一些或全部被下载到远程计算机装置2420上。对于数据被加密的实施方式来说，在数据加载在远程计算机装置2420内的存储装置上之前或者之后，远程计算机装置可解密数据。在步骤2512，现在存储在远程计算机装置2420中的数据可以被操作。例如，可以对数据执行计算或分析，或者将数据下载或转换到另一个存储介质中。
在本文中公开的装置可被设置成在单次使用(可以包括多次击发)后被处理，或者它们可被设计成多次使用。但是，在任一情况下，装置在至少一次使用后可被重新调整以便重新使用。重新调整可包括装置的拆卸、接着清洁或替换特定部件以及随后重新组装的步骤的任意组合。特别是，装置可被拆卸，并且装置的任意数目的特定部件或部分可选择性地以任何组合被替换或者除去。一旦清洗和/或替换特定部分，装置就可在正重新调整的设施上或者由手术团队就在外科手术前被重新组装以便随后的使用。本领域技术人员将会理解，装置的重新调整可利用用于拆卸、清洗/替换以及重新组装的各种技术。所述技术的使用以及获取的重新调整后的装置都落入本发明的范围内。
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，该器械然后可被灭菌。在一种灭菌技术中，器械被放置在闭合并密封的容器中，诸如盖有一片TYVEK(高密度聚乙烯合成纸袋)的热成形塑料壳。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。灭菌的器械然后可被存储在灭菌容器中。密封的容器保持器械处于灭菌状态，直到其在医疗设施中被打开。
优选的是对装置进行灭菌处理。这可以通过本领域技术人员已知的任何方式来实现，例如通过β或者γ射线、环氧乙烷、蒸汽或其它方法。
虽然本发明对多种实施方式进行了描述并且虽然已非常详细地对图示的实施方式进行了说明，但申请人并不意于限制或以任何方式将权利要求书的保护范围限制到这些细节。本领域技术人员可以容易地想到其它优点和变型。本发明的各种实施方式相对于现有技术的缝合方法有了巨大的改进，在现有技术中，需要使用单个钉仓中的具有不同尺寸的缝钉以获得具有不同成形(最终)高度的缝钉。
因此，本发明涉及内窥镜手术和设备。但是，这里使用的术语“内窥镜”不应被理解为将本发明限制到仅结合内窥镜管(即，套管或套管针)使用的外科缝合和切断器械。相反，相信本发明可以应用于任何接近受限的手术，包括但不限于腹腔镜手术以及开放式手术。此外，本发明的各种钉仓的独特且新颖的方面可以在结合其它形式的缝合设备使用时具有实用性，且不脱离本发明的精神和范围。
所述被部分或全部引用于此作为参考的任何专利、公开文献或其他公开资料仅仅在被引用的材料不会与本公开中存在的定义、声明或上述其他公开资料相冲突的程度上被引用于此。因而，在这里清楚阐述的公开内容替代被引用于此作为参考的任何冲突资料。

Claims (10)

1.一种方法，包括：
在涉及外科切割和紧固器械的外科手术过程中将来自外科切割和紧固器械的至少一个传感器的数据存储在该外科切割和紧固器械的控制单元的存储装置中；
在所述外科手术之后在所述控制单元和远程计算机装置之间建立数据链路；并且
将所述数据从所述外科切割和紧固器械的所述控制单元下载到所述远程计算机装置。
2.根据权利要求1所述的方法，其中，所述数据链路包括有线数据链路。
3.根据权利要求1所述的方法，其中，所述数据链路包括无线数据链路。
4.根据权利要求1所述的方法，还包括：
在将所述数据存储在所述存储装置中之前对所述数据进行加密；并且
在将所述数据下载到所述远程计算机装置之后对所述数据进行解密。
5.根据权利要求1所述的方法，其中，所述外科切割和紧固器械包括：
手柄；
连接到所述手柄上的轴；以及
连接到所述轴上的端部执行器，所述端部执行器包括可枢转地连接的、相对的第一钳口构件和第二钳口构件。
6.根据权利要求5所述的方法，其中：
所述手柄包括击发扳机；并且
所述端部执行器包括切割器械，所述切割器械在所述击发扳机被致动时沿纵向穿过所述端部执行器。
7.根据权利要求6所述的方法，其中，所述手柄还包括与所述击发扳机分离的闭合扳机，所述闭合扳机用于在被致动时使所述第一钳口构件和第二钳口构件将组织夹钳在所述第一钳口构件和第二钳口构件之间。
8.根据权利要求7所述的方法，其中：
所述至少一个传感器包括与所述控制单元通信的砧座闭合传感器，所述砧座闭合传感器感测所述第二钳口构件的闭合；并且
所述控制单元的所述存储装置存储来自所述砧座闭合传感器的数据。
9.根据权利要求7所述的方法，其中：
所述至少一个传感器包括与所述控制单元通信的闭合扳机传感器，所述闭合扳机传感器感测所述闭合扳机的致动；并且
所述控制单元的所述存储装置存储来自所述闭合扳机传感器的数据。
10.根据权利要求7所述的方法，其中：
所述至少一个传感器包括位于所述第一钳口构件中并且与所述控制单元通信的砧座闭合载荷传感器，所述砧座闭合载荷传感器感测由于所述第二钳口构件的闭合而施加在所述第一钳口构件上的载荷；并且
所述控制单元的所述存储装置存储来自所述砧座闭合载荷传感器的数据。
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US8746529B2 (en) 2014-06-10
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RU2009135318A (ru) 2011-03-27
JP2010075695A (ja) 2010-04-08
CA2679805A1 (en) 2010-03-23
EP2165663A2 (en) 2010-03-24
US20120074196A1 (en) 2012-03-29
US20090076534A1 (en) 2009-03-19
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BRPI0912498A2 (pt) 2012-05-02
US8161977B2 (en) 2012-04-24

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