CN1939230B - 具有载荷传感控制电路的外科缝合器械 - Google Patents

具有载荷传感控制电路的外科缝合器械 Download PDF

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CN1939230B
CN1939230B CN2006101447554A CN200610144755A CN1939230B CN 1939230 B CN1939230 B CN 1939230B CN 2006101447554 A CN2006101447554 A CN 2006101447554A CN 200610144755 A CN200610144755 A CN 200610144755A CN 1939230 B CN1939230 B CN 1939230B
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surgical instruments
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pressure transducer
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弗雷德里克·E·谢尔顿四世
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B17/07207—Surgical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical 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
    • A61B2017/07214—Stapler heads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means

Abstract

一种可在内窥镜或腹腔镜手术中插入到治疗部位用来同时缝合和切割组织的外科器械，其包括战略地设置为用于闭环控制和监控的载荷传感压力传感器。位于缝钉施放组件(端部执行器)中的载荷传感可以提供反馈，用于防止在组织不足或太多的情况下击发，或者用来感测是否恰当存在支撑材料，以在感测到击发后展开支撑材料。

Description

具有载荷传感控制电路的外科缝合器械
相关申请的交叉引用
本申请是序列号为No.11/082495、名为“Surgical Instrument Incorporating anElectrically Acutated Articulation Mechanism”、在2005年3月17日提交的美国专利申请的部分继续申请，该申请的全部内容通过引用并入本文。
技术领域
本发明总的涉及能够将多排缝钉应用于组织然后将位于缝钉排之间的组织切除的外科缝合器械，更具体地，涉及有关缝合器装置的改良和用于形成这种缝合器装置的各种部件的过程的改进，包括向被切割和缝合的组织施加支撑材料。
背景技术
内窥镜和腹腔镜外科器械一般比传统开放式外科装置更具优势，因为较小的切口易于减少术后恢复时间和并发症。腹腔镜和内窥镜外科手术的应用已经相当普遍，并为进一步发展该方法提供额外的动力。在腹腔镜手术中，手术通过一个小的切口在腹腔内部进行。同样地，在内窥镜方法中，通过经由皮肤上的小的入口创伤插入的狭窄内窥镜管在身体的任何中空内脏内进行手术。
腹腔镜和内窥镜手术通常需要对手术区域充气。因此，任何插入到体内的器械必须密封，以确保气体不会通过入口进入或排出身体。并且，腹腔镜和内窥镜手术通常需要外科医生在远离切口的器官、组织和/或脉管内进行操作。因此，在这些手术中使用的器械通常长且细，同时其功能可从器械的近端控制。
在适于通过套管针的插管在所需的手术部位精确定位端部执行器的内窥镜外科器械领域已经取得了显著的发展。这些端部执行器以多种方式与组织接合以实现诊断或治疗效果(例如，内切割器、抓钳、切割器、缝合器、夹具施放器、接入装置、药物/基因治疗传送装置，以及应用超声、RF、激光的能量装置等)。
已知的外科缝合器包括一个端部执行器，其同时在组织上制造纵向切口并在该切口的相对侧上施加数排缝钉。端部执行器包括一对相配合的钳口部件，当所述装置在内窥镜或腹腔镜应用中使用时，所述钳口部件能够通过插管通道。其中一个钳口部件接收具有至少两排横向隔开的缝钉的钉仓。另一个钳口部件限定具有与所述钉仓中的缝钉排对准的缝钉形成凹穴的钉砧。所述器械包括多个往复楔形件，其在被向远侧驱动时，通过所述钉仓中的开口并与支撑所述缝钉的驱动器接合，以向所述钉砧击发缝钉。
监控外科缝合器的恰当定位和操作依赖于各种类型的小型视频示波器(例如，内窥镜)。虽然在一定程度上是有效的，但是仍然期望对外科缝合器的操作的更好的监控，特别是这种监控能够允许对外科缝合器执行的各种致动进行闭环控制。
因此，特别需要一种结合有载荷传感能力的改良的外科缝合和切割器械。
发明内容
本发明通过提供一种与电动压力传感器结合的外科器械克服了现有技术中的上述和其他缺陷，其中所述电动压力传感器在所述外科器械被致动时接收压缩载荷。然后，监控电动压力传感器的控制电路响应于所感测到的压缩载荷的产生控制信号，以改善所述外科器械的操作。
在本发明的一个方面，外科器械具有一个缝钉施放组件，其具有第一和第二相对压缩表面，它们夹住要缝合的组织，并从而向压力传感器传递压缩力。所述缝钉施放组件由手柄部分闭合，并通过由手柄部分经轴移动击发构件而被致动。控制电路响应于所感测的缝钉施放组件的压缩载荷向电致动器发送控制信号。因此，可根据成功夹紧的所需的组织量执行所需的一系列操作，避免在没有夹住足够的组织的情况下空击发致动器，或者在夹住过量组织的情况下无效致动。
在本发明的另一个方面，外科器械具有连接在轴上进而连接在手柄部分上的端部执行器。击发构件由所述手柄部分平移并被收纳在轴中纵向往复运动，以致动所述端部执行器，从而在压力传感器上施加压缩载荷。控制电路响应于所接收的来自压力传感器的信号产生控制信号。从而，根据已经开始或者已经成功完成的击发执行预期的一系列操作。
在本发明的又一个方面，外科器械具有允许使端部执行器关节运动的关节运动的轴。控制电路接收来自轴的关节处的传感器的信号产生控制信号，其中所述关节处的传感器的信号可表示关节运动的角度。因此，根据获得轴和端部执行器所需的关节运动角度执行预期的一系列操作。
本发明还涉及如下方面：
(1)一种外科器械，包括：
端部执行器，其包括相对的第一和第二压缩表面；
近侧连接到所述端部执行器上的轴；
近侧连接到所述轴上的手柄部分，包括通过轴可操作地连接的致动机构，以选择地致动所述端部执行器；
压力传感器，其定位成在端部执行器被致动时接收压缩载荷；以及
控制电路，其响应于从所述压力传感器接收的信号产生控制信号。
(2)如第(1)项所述的外科器械，还包括连接到所述手柄部分上的指示器，该指示器由控制信号启动。
(3)如第(1)项所述的外科器械，其中，所述致动机构包括闭合机构，操作该闭合机构可以选择地在组织上闭合所述第一和第二相对的压缩表面，所述压力传感器定位在所述端部执行器中，以接收压缩载荷。
(4)如第(3)项所述的外科器械，还包括装纳在轴中可纵向往复运动的击发构件，其中所述端部执行器包括缝钉施放组件，所述缝钉施放组件响应于所述击发构件的运动切割和缝合所夹紧的组织。
(5)如第(4)项所述的外科器械，还包括击发锁定机构，所述击发锁定机构响应于来自所述控制电路的控制信号防止击发，其中所述控制电路被可操作地设置成响应于所感测的压缩载荷与阈值之间的比较而产生控制信号。
(6)如第(1)项所述的外科器械，还包括装纳在轴中可纵向往复运动的击发构件，其中所述端部执行器包括缝钉施放组件，该缝钉施放组件响应于所述击发构件的运动切割和缝合所夹紧的组织。
(7)如第(6)项所述的外科器械，其中，所述压力传感器定位在所述击发构件附近，以接收表征击发的压缩载荷。
(8)如第(7)项所述的外科器械，其中，所述击发构件包括横向扩展部分，所述横向扩展部分定位成可在限定于轴中的凹槽内纵向平移，所述压力传感器安装在轴中的凹槽内，以与所述击发构件的接近所述击发构件的完全击发行程的扩展部分接触，。
(9)如第(7)项所述的外科器械，其中，所述击发构件包括楔形件，所述楔形件定位成可在所述缝钉施放组件中平移，所述压力传感器定位在所述缝钉施放组件中，以响应于击发构件将所述楔子向远侧的平移而接收压缩载荷，从而穿过所夹紧的组织分配和形成缝钉。
(10)如第(9)项所述的外科器械，其中，所述压力传感器定位在所述缝钉施放组件的远端，以接触处于完全击发行程的楔形件。
(11)如第(9)项所述的外科器械，其中，所述压力传感器定位在楔形件的击发行程的纵向中间部分，位于楔形件下方的表面上。
(12)如第(9)项所述的外科器械，其中，所述压力传感器包括多个沿所述楔子的一部分的完全击发行程纵向排列的压力传感器。
(13)如第(9)项所述的外科器械，其中，所述压力传感器包括设置在底面上的细长的压力传感器，所述底面在楔形件完全击发行程期间与楔形件接触。
(14)如第(9)项所述的外科器械，其中，所述击发构件还包括击发杆，所述击发杆具有近侧与所述楔子邻接的接触表面，所述压力传感器与所述击发杆的所述接触表面连接。
(15)如第(1)项所述的外科器械，其中，所述轴还包括关节，所述致动机构包括关节运动机构，所述关节运动机构被可操作地设置成通过使所述端部执行器围绕所述关节旋转而致动所述端部执行器，所述压力传感器定位成接收来自关节运动机构的表征所述关节的关节运动角度的压缩力。
(16)如第(15)项所述的外科器械，其中，所述压力传感器包括极限传感器。
(17)如第(15)项所述的外科器械，其中，所述压力传感器包括连续角度传感器。
(18)如第(15)项所述的外科器械，还包括关节运动电致动器，所述控制电路可操作地设置成响应于所感测的关节运动角度而控制所述关节运动电致动器。
(19)如第(15)项所述的外科器械，还包括关节运动电锁定致动器，所述控制电路可操作地设置成响应于所感测的关节运动角度而控制所述关节运动电锁定致动器。
(20)如第(1)项所述的外科器械，其中，所述压力传感器包括电活化聚合物压力传感器。
(21)一种外科器械，包括：
缝钉施放组件，其包括相对的第一和第二压缩表面；
近侧连接到所述缝钉施放组件上的轴；
装纳在轴中可纵向往复运动的击发构件；
近侧连接到轴上的手柄部分，其通过轴可操作地连接，以在组织上闭合所述相对的第一和第二压缩表面，并使所述击发构件平移，从而致动所述缝钉施放组件；
响应于指令信号的电致动器；
压力传感器，其定位成在端部执行器被致动时接收压缩载荷；以及
控制电路，其响应于从所述压力传感器接收的信号产生控制信号。
(22)如第(21)项所述的外科器械，其中，所述电致动器包括支撑展开致动器。
(23)如第(21)项所述的外科器械，其中，所述电致动器包括击发锁定机构，所述击发锁定机构连接到所述击发构件上，以响应于控制信号停止击发。
(24)一种外科器械，包括：
端部执行器；
近侧连接到所述端部执行器上的轴；
装纳在轴中可纵向往复运动的击发构件；
近侧连接到所述轴上的手柄部分，其可操作地设置成使击发构件平移，以致动所述端部执行器；
压力传感器，其定位成响应于所述击发构件的平移而接收压缩载荷；以及
控制电路，其响应于从所述压力传感器接收的信号产生控制信号。
(25)如第(24)项所述的外科器械，还包括弹性回缩偏压装置和抗阻挡电致动器，所述弹性回缩偏压装置位于所述击发构件上，所述抗阻挡电致动器响应于控制信号允许所述击发构件通过弹性回缩偏压装置回缩。
(26)如第(24)项所述的外科器械，还包括电活化药物输送致动器，其响应于控制信号在端部执行器处分配药物。
(27)如第(24)项所述的外科器械，其中，所述端部执行器包括缝钉施放组件，所述外科器械还包括电活化支撑展开致动器，其响应于控制信号从所述缝钉施放组件展开支撑材料。
(28)一种外科器械，包括：
端部执行器；
近侧连接到所述端部执行器上的轴；
形成在轴上的关节；
压力传感器，其定位成响应于关节的关节运动而接收压缩载荷；以及
控制电路，其响应于从所述压力传感器接收的信号产生控制信号。
(29)如第(28)项所述的外科器械，还包括关节运动致动器，其连接在关节上进行关节运动运，其中所述控制电路可操作地设置成通过将所指令的关节运动角度和从压力传感器感测的压缩载荷进行比较而产生控制信号。
(30)如第(28)项所述的外科器械，还包括电致动关节锁，其响应于控制信号选择地将关节锁定在当前关节运动角度。
附图说明
从附图及对其的说明更清楚地了解本发明的这些和其他目的和优点。
结合进来并作为本说明书的一部分的附图与上述本发明的简述以及下文对实施方式的详细描述一起说明了本发明的实施方式，用于解释本发明的原理。
图1是外科缝合和切割器械的部分切去的侧视图，其中缝钉施放组件处于打开位置，下部支撑垫被去除以暴露钉仓，并且细长轴被部分切去以露出符合本发明的闭环控制系统的部件，包括手柄部分中的以虚线示出的部件。
图2是图1所示外科缝合和切割器械的闭环控制电路的方框图。
图3是图1中缝钉施放组件的细长缝钉通道的左前等轴测图，该通道结合有细长的电活化聚合物(EAP)传感器带，用于感测载荷。
图4是图1中缝钉施放组件的细长缝钉通道的左前等轴测图，该通道结合有对准的多个EAP传感器带，用于感测载荷。
图5是图1的外科缝合和切割器械的细长轴的框架底组件的关节的俯视图。
图6是图5的关节在向左侧关节运动状态下的俯视图。
图7是用于图1的外科缝合和切割器械的结合有击发杆传感器的细长轴的分解等轴测图，其中省略了支撑展开系统但包含可选择的EAP纤维关节运动致动器。
图8是图7的外科缝合和切割器械的细长轴的等轴测图，其省略了闭合套管和缝钉施放组件以露出击发杆传感器和击发杆。
图9是致动在图8的外科缝合和切割器械的细长轴中的击发杆传感器的击发杆的近端的等轴测详示图。
图10是图8的细长缝钉通道的远侧部分的详示图，其中包括位于击发杆通道槽远端的可选择的击发杆传感器。
图11是结合有用于检测图1的外科缝合和切割器械的缝钉驱动的细长EAP压力传感器的可选择的钉仓的分解等轴测图。
图12是结合有用于检测图1的外科缝合和切割器械的缝钉驱动的对准的多个EAP压力传感器的额外可选择的钉仓的分解等轴测图。
图13是钉仓和击发杆远侧部分的分解等轴测图，该击发杆具有抵接楔形滑块的远侧EAP压力传感器，该滑块在图1的外科缝合和切割器械的击发期间驱动缝钉。
具体实施方式
转至附图，其中相同的附图标记表示相同的部件，在图1中，外科缝合和切割器械10包含手柄部分12，操纵该手柄部分以定位由固定端部执行器具体说是缝钉施放组件16形成的执行部分14，其远侧连接到细长轴18上。所述执行部分14的尺寸适于通过用于内窥镜或腹腔镜外科手术的套管针(未示出)的插管插入，其中通过朝着手柄部分12的手枪式握把26压下闭合扳机24，使缝钉施放组件16的上部钳口(钉砧)20和一个下部钳口22闭合。
一旦插入到被充气的体腔内或脉管内，外科医生可以通过拧动接合手柄12的远端和细长轴18的近端的轴旋钮27，使执行部分14绕其纵向轴线旋转。外科医生可以选择地将手柄部分12上的关节运动控制杆28向任一横向侧移动，以引起细长轴18的远端部分和缝钉施放组件16围绕关节30关节运动。从而，缝钉施放组件16可接近被其他组织遮掩的组织或是允许内窥镜定位在缝钉施放组件16之后。这样定位之后，可以释放闭合扳机24，打开钉砧20，从而抓住并定位组织。一旦满意，外科医生压下闭合扳机24直到锁在手枪式握把26上，从而夹紧缝钉施放组件16。然后，压下击发扳机32，压下的次数可能是击发指示器33上的参考击发进程的数倍。将击发扳机32向闭合扳机24和手枪式握把26拉动，从而向远侧推进击发构件，所示的击发构件包含一个连接在远侧击发杆36上的近侧击发杆34，并被支撑在将手柄部分12与缝钉施放组件16连接的框架底组件38内。外部闭合套管40在框架底组件38上纵向平移，以响应于闭合扳机24使钉砧20枢转。
为了辅助缝合薄层和/或厚层组织，上支撑垫42和下支撑垫44的支撑材料保持在钉砧20的每一个内表面上和接合于下部钳口22的细长缝钉通道47内的钉仓46上。在缝钉施放组件16击发之后，沿被夹组织被切割和缝合的支撑垫42、44通过驱动上、下支撑夹48、50而脱离接合，以便当击发扳机32释放时，保持组织的两个被缝合和被切割的端部，按下闭合释放按钮52以解锁闭合扳机24，从而打开缝钉施放组件16。
优选的是，击发杆36的远端包括刀片或连接到刀片上，该刀片横穿钉仓46中的垂直槽，以切割所夹住的组织和支撑垫42、44。所述刀片连接在楔形组件上，该楔形组件将缝钉穿过被夹组织和支撑垫42、44向上顶出钉仓46，以闭合和形成在钉砧20上。此后，通过击发行程端部(end-of-firing-travel)释放机构和手柄部分12上的回缩偏压件缩回击发杆36。外科医生可以通过驱动位于手柄部分12顶部上的手动回缩杆54在部分击发后中止击发和/或进行击发元件34、36的手动回缩。
在图1-2中，根据本发明，闭环控制系统55通过监控适当操作和电控各个部件而改善外科缝合和切割器械10的操作。用户可以按下电源开关56以利用图示为电池58的电源启动闭环控制系统55。手柄12上的可视化结构(状态指示器)可以结合到电源开关56上，以指示所述闭环控制系统55所处的状态(例如，颜色/闪烁照明和/或电源按钮56的字符信息)，诸如“POWER ON”、“OPERATIONAL-SELF-TEST PASSED”、“LOAD STAPLE CARTRIDGE”、“LOAD BUTTRESS PADS”、“SYSTEM LOADED/AWAITING FIRING”、“FAULT DETECTED”等。也可以通过结合有线或无线(例如蓝牙)协议把闭环控制系统55连接到外部图形化用户界面(例如个人计算机)来实现附加的设计灵活性。
闭环控制系统55包含控制器60，其有利地接收来自监控外科缝合和切割器械10的操作的电传感器的信号。特别地，载荷传感器，诸如介于钉仓46和细长缝钉通道47之间的细长的电活化聚合物(EAP)载荷带62(图3)或EAP带直线列63(图4)，监控缝钉施放组件16上的夹紧力的大小。然后，确定获得了适合的夹紧力，用作控制器60在击发前致动防治无意击发的锁定致动器64的先决条件。
EAP的一个有用的特性是其传感(换能)能力。例如，用加载的悬臂形式的EAP带能获得卓越的动态响应(传感模式)。发现阻尼电响应在高达100Hz的高带宽时具有很高的重复性。这种直接的机械-电行为与源于所加的应力的内部离子活动性有关。这意味着，如果我们施加以有限的软相位(soft-phase)通量但不允许电流通量，其产生一定的可动态监控的共轭电场。在这个意义上，EAP的确是多功能的：集结构的、致动和传感能力于一身。EAP致动器将在下文更加详细的说明。
示例性的击发锁定致动器64可以结合在手柄部分12内，如共有待审申请号为No.11/095428、名称为“Surgical Instrument Incorporating EAP Complete FiringSystem Lockout Mechanism”、在2005年3月31日递交的美国专利申请中描述的那样，该申请的内容通过引用并入本文。另外，击发锁定致动器64可以结合在执行部分14上，如共有待审申请号为No.11/066371、名称为“Surgical StaplingInstrument Having An Electroactive Polymer Actuated Single Lockout MechansimFor Prevention Of Firing”、在2005年2月25日递交的美国专利申请中描述的那样，该申请的内容通过引用并入本文。
继续参照图1-2，控制器60还接收来自一个或多个关节运动传感器70的信号。该信号响应于关节的关节运动角度，可以是连续的和/或离散的关节运动极限阈值。这个信息可以用于执行关节运动致动器72的闭环控制。电致动关节运动的示例性方案在三篇共有待审的专利申请中有所说明：(1)序列号为No.11/082495、名称为“Surgical Instrument Incorporating an Electrically ActuatedArticulation Mechanism”、在2005年3月17日提交的美国专利申请；(2)序列号为No.11/096096、名称为“Surgical Instrument Incorporating an ElectricallyActuated Pivoting Articulation Mechanism”、在2005年3月31日提交的美国专利申请；(3)序列号为No.11/096158、名称为“Surgical Instrument Incorporating anElectrically Actuated Articulation Mechanism”、在2005年3月31日提交的美国专利申请，这三篇专利申请通过应用并入本文。一旦处于所需的关节运动角度，控制器60可以重新接合电致动关节运动锁74，以保持所述关节运动。示例性的关节运动锁在共有待审序列号为No.11/092053、名称为“Surgical InstrumentIncorporating an Electrically Actuated Articulation Locking Mechanism”、在2005年3月29日提交的美国专利申请中有所说明，该申请的内容通过引用并入本文。
应当理解，借助本申请的公开，符合本发明的应用可以结合机械关节运动和/或机械锁定轴而不是电关节运动和/或电锁定轴。而且，来自控制器60的控制信号可以仅为用户提供证实获得预期的关节运动角度的视觉和/或听觉指示，从而进一步关节运动的指令可被中断和/或所述关节可被手动锁定。
在图4-5中，示例性的关节30包含框架底组件38的近侧框架底部分80，其具有圆柱形的销槽82，该销槽与形成于左侧和右侧远侧突出框架臂86、88之间的垂直槽84连通。框架底组件38的远侧框架底部分90包含逐渐变细的向近侧突出的臂92，其终止于圆柱形销94，该圆柱形销94可枢转地收纳在近侧框架底部分80的圆柱形销槽82内。
在垂直槽84的远侧部分，左侧和右侧驱动/传感EAP层压堆96、98插入到逐渐变细的向近侧突出的臂92的相应侧上，并相应地连接到左侧和右侧远侧突出的框架臂86、88上。所述左侧驱动/传感EAP层压堆96包含一个左侧EAP关节运动致动器100，其中左侧薄的EAP压力传感器102跨过其内表面抵靠在所述变细的向近测突出的臂92上。相似地，右侧驱动/传感EAP层压堆98包含一个右侧EAP关节运动致动器104，其中右侧薄的EAP压力传感器106跨过其内表面抵靠在所述变细的向近侧突出的臂92上。当选定的EAP关节运动致动器104被驱动时(扩展)，通过所述左侧和/或右侧薄的EAP压力传感器102、106传感表示关节30的关节运动角度的压力读数。
除了连续的关节运动角度传感之外，左侧和右侧薄的EAP极限传感器108、110设置在垂直槽84的近侧部分，位于相应的左侧和右侧枢轴档块112、114上，所述档块设置有一定的角度以在允许的最大关节运动角度时与变细的向近侧突出的臂92邻接。
回到图1-2，控制器60还接收来自检测远侧击发行程的击发杆传感器120的信号。从而控制器60可以有利地启动支撑展开系统121，以在击发后自动展开所述支撑垫42、44，其中所述支撑展开系统21(例如，上、下支撑夹48、50)在共有待审序列号为No.11/181471、名称为“Surgical Stapling Instrument Havingan Electroactive Polymer Actuated Buttress Deployment Mechanism”、在2005年7月14日提交的美国专利申请中有所说明，该申请的内容通过引用并入本文。作为替代方案或者附加方案，控制器60可以因此有利地在击发过程中启动药物分配致动器122以增强治疗效果(例如，凝血剂、粘结剂、抗生素等)，例如在共有待审序列号为No.11/157767、名称为“Surgical Stapling Instrument Having anElectroactive Polymer Actuated Medical Substance Dispenser”、在2005年6月1日提交的美国专利申请中有所说明的那样，该申请的内容通过引用并入本文。可选择地，控制器60可以因此有利地选择地在击发冲程结束时启动和/或停用抗阻挡致动器123，以允许自动的回缩，如同在共有待审的序列号为No.11/181046、名为“Anti-Backup Mechanism for a Multi-Stroke Endeffector Using ElectricallyActive Polymers”、在2005年7月14日提交的美国专利申请中有所说明，该申请的内容通过引用并入本文。
在图7-10中，击发杆传感器120包含一个EAP堆致动器，其设置在可选择的细长轴124内，以便在到达完全击发行程时与击发构件的一部分接触。特别地，所述击发构件在击发杆34的远端包含一个U形夹126，其收纳击发杆36的向上勾起的端部128。U形夹126横向加宽的外形与击发杆传感器120相配合，所述击发杆传感器120安装在框架底组件38内部形成的击发构件槽130内。
在图7中，钉仓46包含一个底部盘134，其具有近侧开口的纵向槽136。多个缝钉驱动器138安座在底部盘134上，位于所述纵向槽136的两侧，其上安有多个缝钉(未示出)。缝钉体140安座在缝钉驱动器138上，为被远侧驱动楔形滑块142向上驱动的缝钉驱动器138提供合适的凹槽，从而将缝钉从形成在缝钉体140上的缝钉孔144推出。组装的钉仓46收纳在细长缝钉通道47中，其中位于底板134上的近侧开口的纵向槽136与细长缝钉通道47内的通道槽146垂直对准。
在图7-8中，击发杆36的远端是E形横梁148，其具有一个当中间销152沿钉仓46内的底部盘134的顶面滑动时，沿细长缝钉通道47的底面滑动的下部基座150。E形横梁148的远侧驱动表面154邻接并驱动楔形滑块142。在远侧驱动表面154上方，凹进的切割表面156沿着钉仓46的顶面并在钉仓46的顶面上方横过，以切割组织。E形横梁148的上部销158接合在钉砧(上部钳口)160(其中省略了支撑夹钳)上以保持间隔。可选择的挠曲闭合套管162包围所述框架底组件38。
详细地参照图7，关节运动与前述方案不同之处在于，上部的左侧和右侧EAP纤维关节运动致动器164、166在其内端部连接到上关节运动臂168上，其中所述上关节运动臂168由从近侧壳框架底部分172向远侧突出的上部柄脚170上突出，其外端部与远侧框架底部分174的相应的相对内表面连接。同样地，下部的左侧和右侧EAP纤维关节运动致动器176、178在其内端部连接到下关节运动臂180上，其中所述上关节运动臂180由从近侧框架底部分172向远侧突出的下部柄脚182上突出，其外端部与远侧框架底部分174的相应的相对内表面连接。从远侧框架底部分174向近侧突出的上部的和下部柄脚184、186被销接，以便分别随着近侧框架底部分172的向远侧突出的上部和下部柄脚170、182旋转。
在图7、10中，除了近侧定位的击发杆传感器120或者作为其替代方案，远侧定位的EAP压力传感器190可以定位在细长缝钉通道47上，以与在完全远侧行程处的楔形滑块142接触。
在图11中，左侧和右侧细长EAP压力传感器200、202位于底部盘134的纵向槽136的两侧，以感测击发过程中楔形滑块142的行进。在图12中，一系列的左侧和右侧压力传感器204、206位于底部盘134的纵向槽136的两侧。在图13中，作为替代或附加方案，击发杆传感器描述为EAP压力传感器210，其位于E形横梁148的远侧驱动表面154上，以记录击发过程中的力，尤其记录当所述楔形滑块142到达完全远侧行程时所传感的力的增大。
应当指出，借助本申请的公开，也可以想到击发传感器结合入手柄而不是或不只结合于执行部分14的击发杆传感器。不具有闭环控制系统55的手柄部分12的示例性方案在共有待审序列号为No.11/052387、名称为“Surgical StaplingInstrument Incorporating A Multi-Stroke Firing Mechanism With Return SpringRotary Manual Retraction System”、在2005年2月7日提交的美国专利申请中有所说明，该申请的内容通过引用并入本文。
应当指出，借助本申请的公开，控制器60可以包括具有包含程序的存储器的微处理器，其监控传感器并为电致动部件产生控制信号。作为另一种选择，控制器60可以包含可编程逻辑阵列、集成元件逻辑门、光逻辑元件或其他电子电路。而且，符合本发明的各个方面的闭环控制系统55的其他部分可以远离所述外科缝合和切割器械10。
电活化聚合物。虽然一些电致动器(例如，螺线管)也可结合入所述外科缝合和切割器械10，但示例性的方案在此描述了有利地使用的电活化聚合物(EAP)，EAP是一组导电掺杂聚合物，当施加电压时所述导电掺杂聚合物改变形状。可以使用电极使所述导电聚合物与某种形式的离子流体或凝胶配对。一旦对电极施加电压电位，离子从流体/凝胶流入或流出导电聚合物，可以引起聚合物的形状变化。通常，可以根据使用的具体聚合物和离子流体或凝胶施加在大约1V-4kV范围内的电压电位。一些EAP在被施加电压时收缩，一些膨胀。所述EAP可以与诸如弹簧或挠性板之类的机械部件配对以改变当施加电压时所造成的影响。
有两种基本类型的EAP，每种类型有多种构型。两种基本类型是纤维束和层压结构。纤维束由大约30-50微米的纤维构成。这些纤维可以被织成很像织物的束，它们因此常常被称为EAP纱线。EAP在被施加电压时将收缩。电极通常由中心线芯和导电外护套组成，所述外护套还用于装纳围绕纤维束的离子流体。可在商业上获得的纤维EAP材料的一个例子由Santa Fe Science and Tec hnology公司制造并且作为PANIONTM纤维出售，其描述于美国专利No.6,667,825中，通过引用将该文献的全部内容并入本文。
另一种类型是层压结构，其包含一个EAP聚合物层、一个离子凝胶层和与层压结构的两侧连接的两个挠性板。当施加电压时，方形层压板在一个方向上膨胀，在相垂直的方向上收缩。一个可商业获得的层压(板)EAP材料的例子来自Artificial Muscle公司，其是SRI实验室的分公司。也可从日本EAMEX获得板状EAP材料，其称为薄膜EAP。
应当注意的是，当对其施加能量时，EAP并不会改变体积；它们只是在一个方向上膨胀或收缩，而在相垂直的方向上做相反的改变。可以使用处于基本形式的层压型，其中保持一侧靠着刚性结构，而将其另一侧像活塞一样使用。层压结构还可以粘附在挠性板的任一侧上。当挠性板EAP的一侧被施加能量时，其膨胀，使板沿相反的方向弯曲。这允许所述板向任一方向弯曲，其取决于在哪一侧施加能量。
EAP致动器通常包含数层或数个纤维束一起协同工作。EAP的机械构造限定所述EAP致动器和它的运动能力。EAP可以形成长股并围绕单根中心电极缠绕。挠性外部套筒将形成用于致动器的另一个电极，同时装纳用于所述装置功能必要的离子流。在这种构造下，当电场施加在电极上时，EAP股缩短。EAP致动器的这种构造称为纤维EAP致动器。同样，层压构造可以在挠性板的任何一侧设置数层或仅仅是数层相叠，以提高其能力。典型的纤维结构具有2-4％的有效变形，而使用很高的电压时典型的层压型变形可达20-30％。
例如，层压EAP复合物可以由阳极板电极层连接到EAP层，EAP层连接到离子单元层，离子单元层连接到阴极板电极层，从而形成层压EAP复合物。多个层压EAP复合物可以通过其间的粘附层固定在堆内，以形成EAP板致动器。应当理解，可以形成能选择地朝任一方向弯曲的相对的EAP致动器。
收缩的EAP纤维致动器可以包括一个纵向铂阴极线，其通过细长圆柱形空腔穿过绝缘聚合物近端盖，所述细长圆柱形空腔在塑性圆柱形壁内形成，塑性圆柱形壁被导电掺杂用作阳极。铂阴极线的远端嵌入绝缘聚合物远端盖内。多个收缩聚合物纤维平行于并阴极线围绕阴极线布置，并且使其端部嵌入相应的端盖中。塑性圆柱形壁环绕相应的端盖周围连接，以封闭圆柱形空腔，从而密封填充收缩聚合物纤维和阴极线之间的空间的离子流或凝胶。当电压施加在所述塑性圆柱形壁(阳极)和阴极线上时，离子流进入收缩聚合物纤维，从而引起其外部直径膨胀，同时其长度收缩，从而将所述端盖拉向彼此。
虽然已经通过几个实施方式说明了本发明并且已经相当详细地说明了示例性实施方式，但并不意味着将后附权利要求书的范围限制或限定在这些详细细节。本领域技术人员可以容易地想到其他优点和变型。
例如，虽然已经描述了具有有利结构的EAP致动器和传感器，但符合本发明的应用可以结合其他类型的致动器和电传感器。
又如，虽然已经对手动操作外科缝合和切割器械10进行了清楚的说明，但应当理解，机器人操纵和/或控制的固定装置也可以结合用于闭环控制和/或监控的载荷传感变换器。这种传感器能特别有效地将触觉反馈到外科医生。
再如，虽然这里说明了特别适合用于内窥镜或腹腔镜外科缝合和切割器械，但符合本发明的各个方面的应用可以是开放式外科应用或进行类似的外科手术。另外，为了诸如载荷传感等目的，环状缝钉可以结合电传感器和/或电致动器。
又如，符合本发明的应用可以包含这里所述的不同的传感器和/或致动器的组合。例如，完全机械闭合和击发系统可以包含由控制器和所显示的状态监控的电传感器。从而当出现警告时外科医生通过“闭合环”中止。另外，一些诸如关节运动或支撑等的特征可被省略。
再如，虽然在示例性方案中描述了分开的闭合和击发机构包含分别的扳机，但是符合本发明的应用可以结合顺序地执行闭合和击发的单个击发扳机。
又如，虽然EAP压力传感器是用于传感夹紧、击发和关节运动的有利的方式，但也可以附加地或作为另一种选择结合其他电传感器，例如近程式传感器(例如，霍耳效应)、电容传感器、微型开关以及位置传感器(例如，电位计)。

Claims (7)

1.一种外科器械(10)，包括：
端部执行器，其包括相对的第一和第二压缩表面；
近侧连接到所述端部执行器上的轴(18)；
近侧连接到所述轴(18)上的手柄部分(12)，包括通过轴(18)可操作地连接的致动机构，以选择地致动所述端部执行器；
多个压力传感器，其设置成在端部执行器被致动时接收压缩载荷；
控制电路，其响应于从所述压力传感器接收的信号产生控制信号，以及
装纳在轴(18)中可纵向往复运动的击发构件(34、36)，其中所述端部执行器包括缝钉施放组件(16)，该缝钉施放组件响应于所述击发构件(35、36)的运动切割和缝合所夹紧的组织；
其特征在于：
所述击发构件(34、36)包括横向扩展部分，所述横向扩展部分定位成可在限定于轴中的凹槽内纵向平移，第一压力传感器安装在轴中的凹槽内，以与所述击发构件的接近所述击发构件的完全击发行程的横向扩展部分接触。
2.如权利要求1所述的外科器械(10)，还包括连接到所述手柄部分(12)上的指示器，该指示器由控制信号启动。
3.如权利要求1所述的外科器械(10)，还包括击发锁定机构，所述击发锁定机构响应于来自所述控制电路的控制信号防止击发，其中所述控制电路被可操作地设置成响应于所感测的所述缝钉施放组件上的夹紧压缩载荷与阈值之间的比较而产生控制信号。
4.如权利要求1所述的外科器械(10)，其特征为，所述致动机构包括闭合机构，操作该闭合机构能够选择地在组织上闭合所述第一和第二相对的压缩表面，第二压力传感器定位在所述端部执行器中，以接收所述缝钉施放组件上的夹紧压缩载荷。
5.如权利要求4所述的外科器械(10)，其特征为，第三压力传感器定位在所述击发构件远端的E形横梁的远侧，以接收表征击发的压缩载荷。
6.如权利要求4所述的外科器械(10)，其特征为，所述击发构件包括楔形件，所述楔形件定位成可在所述缝钉施放组件中平移，第四压力传感器定位在所述缝钉施放组件中，以响应于击发构件将所述楔形件向远侧的平移而接收压缩载荷，使得所述楔形件穿过所夹紧的组织分配和形成缝钉。
7.如权利要求6所述的外科器械(10)，其特征为，第五压力传感器定位在所述缝钉施放组件的远端，以接触处于完全击发行程的楔形件。
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CA2561241A1 (en) 2007-03-30
JP4948955B2 (ja) 2012-06-06
DE602006011547D1 (de) 2010-02-25
EP1769756A1 (en) 2007-04-04
AU2006222763A1 (en) 2007-04-19
US20060212069A1 (en) 2006-09-21
EP1769756B2 (en) 2013-07-10
ATE454094T1 (de) 2010-01-15
AU2006222763B2 (en) 2012-12-06
CN1939230A (zh) 2007-04-04
EP1769756B1 (en) 2010-01-06

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