CN101181167A - 用于手术工具的柔性肘节 - Google Patents

用于手术工具的柔性肘节 Download PDF

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CN101181167A
CN101181167A CNA2007101693676A CN200710169367A CN101181167A CN 101181167 A CN101181167 A CN 101181167A CN A2007101693676 A CNA2007101693676 A CN A2007101693676A CN 200710169367 A CN200710169367 A CN 200710169367A CN 101181167 A CN101181167 A CN 101181167A
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T·G·库珀
S·C·安德森
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Abstract

一种医疗器械，其包括：一个柄，其具有一个远端部分和一个近端部分；一个肘节，其具有一个近端部分和一个远端部分，所述肘节的近端部分连接到所述肘节的远端部分，所述肘节包括：一个柔性管状支撑部件，其从所述肘节的所述近端部分延伸到所述肘节的所述远端部分；以及一个包裹在所述支撑部件周围的外部层，所述外部层具有比所述支撑部件的硬度更低的硬度，所述外部层包括至少三个腔管，所述腔管从所述肘节的所述近端部分延伸到所述肘节的所述远端部分；所述器械进一步包括至少三条驱动缆线，所述缆线中的每一条缆线从所述肘节的远端部分穿过所述至少三个腔管中的一个对应腔管到所述肘节的远端部分。

Description

用于手术工具的柔性肘节
本申请是于2005年5月16日提交的名称为“用于手术工具的柔性肘节”的中国专利申请200380103344.5的分案申请。
背景技术
本发明一般涉及外科手术工具，更具体地是涉及用以进行机器人外科手术(robotic surgery)的手术工具中的柔性肘节机构。
微创手术技术方面的进步使得以微创方式进行的外科手术数目急剧增加。微创医疗技术的目的是为了减少诊断或手术期间破坏的无关组织的量，从而减少病人的康复时间、不适感和有害的副作用。利用微创手术技术，还可显著地缩短一个标准外科手术所需的平均住院时间。因此，更多地采用微创技术可以节省大量的住院时间，而且仅就住院费用而言每年就可节省数百万美元。利用微创手术技术，也可以减少病人的康复时间、病人的不适感和外科手术的副作用。
微创手术最常见的形式就是内窥境检查。内窥境检查最常见的形式就是腹腔镜检查，腹腔镜检查是在腹腔内进行的微创检查和手术。在标准的腹腔手术中，病人的腹部被吹入气体，插管套穿过小(大约1/2英寸)切口，从而为腹腔镜手术器械提供入口。腹腔镜手术器械通常包括一个腹腔镜(用于观察手术部位)和工作器械。这些工作工具类似于那些在常规(开腔)手术中使用的工具，所不同的是每个工具的操作末端或末端执行器都通过一根延长管与该工具的操作柄分离。此处所用的术语“末端执行器”表示手术器械的实际操作部分，其可包括例如钳子、抓紧器、剪刀、吻合器以及持针器等。为了进行手术过程，外科医生将这些工作工具或器械穿过插管套，使其到达内部的手术部位并在腹腔外操纵这些器械。外科医生通过监视器监控手术的过程，该监视器显示出从腹腔镜取得的手术部位的图像。类似的内窥境技术应用于下列检查中，例如关节内窥境检查、后腹腔镜检查、骨盆镜检查、肾镜检查、膀胱镜检查、池囊镜检查(cisternoscopy)、窦镜检查、子宫镜检查、尿道镜检查等等。
目前的微创手术(minimally invasive surgical，MIS)有很多缺点。例如，现有的微创器械所进行的手术没有开腔手术所具有的控制工具的柔性。大多数的现有的腹腔镜工具都有刚性轴，因此很难通过所述的小切口到达工作部位。另外，很多内窥境器械的长度和结构都会降低医生的觉察能力，这种觉察能力可以感受到由组织或器官施加到相关工具的末端执行器上的力。内窥境工具缺乏灵活性和灵敏性是微创手术发展的一个主要障碍。
正在开发的微创远距离手术机器人系统能够在体内手术部位中工作时增加外科医生的灵活性，也可以使外科医生远距离对病人进行手术。在远距离手术系统中，外科医生经常配有计算机工作站提供的手术部位的图像。医生一边在合适的观察器或显示器上观察手术部位的三维图像，一边通过操纵工作站的主输入端或控制装置对病人执行手术过程。主输入端控制以伺服系统方式运行的手术工具的动作。在手术过程中，远距离手术系统响应于主控制机构的操作从而驱动和控制各种具有末端执行器(例如组织抓紧器、针驱动器等)的手术器械或工具，能够执行外科医生的功能，例如，持拿或驱动手术针、抓紧血管或解剖组织等。
一些手术工具利用滚动一倾斜-摆动(roll-pitch-yaw)机构来提供末端执行器沿三个正交轴线旋转运动的三个角度。通常倾斜和摆动旋转由一个连接在该工具的柄和末端执行器之间的肘节机构来提供，而滚动旋转运动通常由柄的转动来提供。在大约90度的倾斜位置处，摆动和滚动转动会重叠，导致一个旋转运动角度丧失，这种情况称为奇点。
发明内容
本发明涉及具有肘节机构的一种工具的替换实施例，该肘节机构所提供的倾斜和摆动转动方式使得工具的滚动、倾斜和摆动不会出现奇点。所述肘节机构具有一个柔性管状结构，该柔性管状结构可以由一个柔性管或一系列连接到弹簧或类似柔性组件上的盘状物形成。驱动缆线或柔性线(例如，由镍钛合金制成)延伸穿过肘节机构，并用于使柔性肘节在倾斜和摆动旋转方向弯曲。滚动方向的转动可以通过转动一个与肘节机构相连的工具柄来实现。
根据本发明的一个方面，一个肘节机构包括一个微创手术器械，该微创手术器械包括一个延长柄，该延长柄具有一个工作端、一个近端和一个位于工作端和近端之间的柄轴；以及一个末端执行器。一个肘节部件具有一个柔性管和一个内部弹簧，所述柔性管和内部弹簧包括与所述延长柄的工作端相连的近端部分和与所述末端执行器相连的远端部分。所述内部弹簧被布置在所述柔性管的内腔中，而且其轴线平行于所述柔性管的轴线。多条驱动缆线(或线)具有与所述末端执行器相连的远端部分，并从所述远端部分穿过所述肘节部件朝所述延长柄方向延伸到近端部分，该近端部分是可驱动的，从而使所述肘节部件在倾斜和摆动转动的方向上弯曲。如果用驱动线，那么这些驱动线也可以帮助支撑所述末端执行器。
在某些实施例中，所述驱动缆线被置于所述内部弹簧的一个中空内部。至少三条驱动缆线连接到所述末端执行器。所述驱动缆线的所述近端部分连接到一个万向板，该万向板被设置为驱动所述缆线并邻近所述延长柄的所述近端。所述驱动缆线可被置于所述内部弹簧和所述柔性管之间。所述柔性管可包括内部轴向槽，该轴向槽由所述内部弹簧的外表面界定从而形成用以接收所述驱动缆线的腔管。所述柔性管可以包括多个横向缺口，这些横向缺口相对于所述柔性管的轴线大体上是横向的。
根据本发明的另一个方面，一个微创手术器械包括一个延长柄，该延长柄具有一个工作端、一个近端和一个位于工作端和近端之间的柄轴；以及一个末端执行器。一个肘节部件具有一个柔性管，该柔性管包括一个轴线，该轴线延伸通过一个由一个管壁包围的内部。所述柔性管的所述管壁包括多个基本平行于所述柔性管的所述轴线定向的腔管。所述肘节部件具有一个与所述延长柄的工作端相连的近端部分和一个与所述末端执行器相连的远端部分。多条驱动缆线具有与所述末端执行器相连的远端部分，并从所述远端穿过所述肘节部件的管壁的腔管朝所述延长柄的方向延伸到近端部分，该近端部分是可驱动的，从而使所述肘节部件在倾斜和摆动转动的方向上弯曲。
在某些实施例中，所述柔性管的管壁包括十二个腔管。每条驱动缆线在所述柔性管的管壁的远端部分回环，从而延伸穿过两个相邻的腔管。所述柔性管包括多个横向缺口，这些横向缺口相对于所述柔性管的轴线大体上是横向的。一个外壳包裹在所述柔性管的外表面的周围。所述横行缺口包括缺口的交替层，每个交替层都包括一对彼此相对放置的缺口。每层中的缺口的方向与相邻层的缺口相隔约90度。所述横向缺口形成了肋，所述肋连接在所述肋上方和下方的盘状部分之间。在所述肋的两侧设置有狭缝，所述狭缝基本沿所述柔性管的轴线延伸入所述盘状部分内。
在特定的实施例中，所述柔性管包括一个内管，该内管具有多个大致平行于所述柔性管轴线定向的槽，以及一个包裹在所述内管周围以在所述槽处形成所述腔管的外壳。所述外壳包括一个外部弹簧。柔性管可以包括多个弹簧，每个弹簧均被放置在所述多个槽中的一个槽的周围。内部弹簧可以被放置在所述柔性管的内部的周围。编织外壳可以形成在所述柔性管的外表面上。所述编织外壳具有在所述柔性管的近端和远端之间以顺时针方向缠绕的第一组线，以及在所述柔性管的近端和远端之间以逆时针方向缠绕的并与所述第一组线编结在一起的第二组线。
在某些实施例中，所述柔性管包括多个轴向滑动部件，该轴向滑动部件通过大致平行于所述柔性管轴线的轴向连接彼此可滑行地相连。所述轴向连接包括一个舌槽连接。在另一版本中，每个轴向滑动部件包括一个用于接收一条驱动缆线的腔管。所述柔性管包括多个彼此相连并被放置在所述柔性管的圆周的轴向弹簧。每个轴向弹簧的线圈与相邻轴向弹簧的线圈重叠从而使所述腔管中的一个用于接收一条驱动缆线。所述柔性管可以包括波形弹簧(wave spring)，该波形弹簧具有多个沿着所述柔性管轴线串连起来的波形弹簧区段，该弹簧区段包括高点和低点。一个波形弹簧区段的高点连到相邻波形弹簧区段的低点。
根据本发明的另一个方面，一个微创手术器械包括一个延长柄，该延长柄具有一个工作端、一个近端和一个位于所述工作端和所述近端之间的柄轴；以及一个末端执行器。肘节部件具有一个内部弹簧，其包括一个与所述延长柄工作端相连的近端部分和一个与所述末端执行器相连的远端部分。所述肘节部件具有多个沿着所述内部弹簧的轴线分布的环状盘。每个所述环状盘的内边与所述内部弹簧相连。多条驱动缆线具有连到所述末端执行器的远端部分，并从所述远端穿过所述肘节部件朝所述延长柄的方向延伸到近端部分，该近端部分是可驱动的，从而使所述肘节部件以倾斜和摆动旋转运动的方式弯曲。
在某些实施例中，所述盘包括多个孔，所述驱动缆线延伸穿过所述孔。每个所述盘都包括一对彼此相对放置的内舌片，该内舌片从内边延伸到所述内部弹簧的线圈间的间隙内。相邻的盘被定向为一个盘的内舌片与相邻盘的内舌片相隔约90度。每个所述盘都包括一个外配合表面和一个内配合表面用于在相邻盘间配合，一个盘的所述外配合表面和相邻盘的所述内配合表面配合。所述外配合表面和所述内配合表面大体上是球形的。多个弹性部件中的每个都被放置在相邻盘之间并与相邻盘连接。肘节外壳被放置在所述内部弹簧和所述环状盘外。所述肘节外壳包括一个由不导电材料制成的平螺旋线(flat spiral)。所述平螺旋线包括卷曲边，这些卷曲边在所述螺旋壳的相邻层之间重叠。所述平螺旋线包括大体上平行于所述内部弹簧的轴线定向的凹槽。
附图说明
图1是根据本发明一个实施例的一种手术工具的透视图；
图2是根据本发明一个实施例的一种肘节的剖视图；
图3是图2的肘节沿着III-III线的剖视图；
图4是根据本发明另一个实施例的一种肘节的透视图；
图4A和图4B分别是类似于图4的一种肘节实例的远端部分的俯视图和正视图，具体示出了缆线的布置情况；
图5是根据本发明另一个实施例的一种肘节的透视图；
图6是根据本发明另一个实施例的一种肘节的俯视图；
图7是根据本发明另一个实施例的一种肘节的剖视图；
图8是根据本发明另一个实施例的一种肘节的俯视图；
图9是图8的肘节的正视图，该肘节具有一个工具柄和一个万向板；
图10是根据本发明另一个实施例的一种肘节的俯视图；
图11是图10的肘节的正视图；
图12是根据本发明另一个实施例的一种肘节的正视图；
图13是根据本发明另一个实施例的一种肘节的俯视图；
图14是根据本发明另一个实施例的一种肘节的一部分的剖视图；
图15是图14的肘节在弯曲时的局部剖视图；
图16是根据本发明另一个实施例的一种肘节的透视图；
图17是图16的肘节的俯视图；
图18是根据本发明另一个实施例的一种肘节部分的剖视图；
图19是根据本发明另一个实施例的一种肘节的透视图；
图20是根据本发明另一个实施例的一种肘节的俯视图；
图21是根据本发明另一个实施例的一种肘节的透视图；
图22是根据本发明另一个实施例的一种肘节的一部分的剖视图；
图23和图24是图22肘节中的盘状物的俯视图；
图25是一种用于图22的肘节的一种外壳部件的透视图；
图26是图25的外壳部件的剖视图；
图27是根据本发明另一个实施例的一种肘节的透视图；
图28是根据本发明一个实施例的一种肘节外壳的剖视图；
图29是根据本发明另一个实施例的一种肘节外壳的剖视图；
图30是根据本发明另一个实施例的一种肘节外壳的一部分的透视图。
具体实施方式
在此所用的“末端执行器”指的是实际工作的远端部分，该部分能够通过肘节部件操纵进行某项医疗功能，例如，对目标组织进行预定的处理。例如，某些末端执行器具有单个操作部件，例如解剖刀、刀片或电极。其他的末端执行器具有一对或多个操作部件，例如镊子、抓紧器、剪刀或施夹钳。在某些实施例中，盘状物或椎骨状物具有孔口，这些孔口共同界定了沿肘节的纵向腔管或空间，从而提供了一个用于大量替换元件或工具中任一个的通道，这些替换元件或工具与末端执行器相连。具体实例包括，用于电动末端执行器的导体(例如电外科电极、转换器、传感器等)；用于液体、气体或固体的管道(例如，用于吸入、吹入、灌入、液体处理、附件导入、切片取出等)；用来驱动末端执行器部件动作的机械元件(例如，用于操作夹子、镊子、剪子的缆线、柔软元件或关节元件)；波导器；声导元件；光纤元件等等。这样的纵向管道可以配有衬里、绝缘体或导向元件，例如弹性聚合物管、螺旋线绕管等。
本文中使用的“手术器械”、“器械”、“外科工具”、“工具”指的是如下部件：该部件具有一个工作末端，该工作末端将一个或多个末端执行器导入病人腔体内的手术部位，而且是从腔体外可驱动的，以操纵一个或多个末端执行器，从而对手术部位的目标组织进行处理或执行医疗功能。所述器械或工具通常包括一个在远端带有末端执行器的柄，所述器械或工具优选通过远距离手术系统以伺服方式驱动，从而执行诸如持拿或驱动手术针、抓紧血管和解剖组织之类的功能。
本文所描述的各种柔性肘节的实施例制造相对便宜，并能够用于烧灼术，虽然它们的并不局限于用于烧灼术。对于MIS应用，工具可插入部分的直径很小，典型地是大约12mm或更小，优选地是5mm或更小，以便于允许很小的切口。应该理解的是，虽然详细描述的实施例标明了这个尺寸范围，但这些实施例可以改变比例以包括更大或更小的器械。
某些肘节实施例采用了一系列盘状物或类似元件，当以倾斜和摆动方式弯曲时，这些元件以类似蛇形的方式运动(例如图14和22)。这些盘状物是环形盘，可并且可以有圆形的内径和外径。通常，这些肘节机构的每个都包括一系列盘状物，例如，大约十三个盘，这些盘可以厚约0.005英寸到0.030英寸，是蚀刻不锈钢盘。较薄的盘可以用在中间部分，而较厚的盘应该用在末端区域以提供额外的强度从而能够吸收缆线力，例如在末端盘周围的缆线U形转弯处施加的力。末端盘可以包括一个沉孔(例如深度大约为0.015英寸)，中心弹簧可以装配到该沉孔中以将来自缆线的载荷转换成中心弹簧的压缩。这些盘可以被串在一个内部弹簧上，该内部弹簧作为腔管用于拉扯某个末端执行器(例如钳子、烧灼连接机构、或带有尖端的链绳)的缆线。内部弹簧也提供了轴向刚度，因此钳子或链绳上的力不会使肘节机构变形。在某些实施例中，这些盘包括一对相对地布置的被内部弹簧抓获的内部突出物或舌片。除了弹簧中某些位置处需产生空隙以插入盘状物的突出物之外，内部弹簧处于一个最大压缩高度(solid height)(当弹簧没有变形时，连续螺距(successive helix pitch)的弹簧丝互相接触)。盘状物在突出物方向上的交替改变可以使倾斜转动和摆动转动的交替改变。典型的内部弹簧由直径0.01英寸的线制成，相邻盘状物彼此之间由四个弹簧线隔开。如果该弹簧由沿着绕边扁平线制成(如同一个软弹簧(slinky))，就可以由缆线施加较高的轴向力而不会使相邻的线跳跨过彼此。
在某些实施例中，每个盘状物都有十二个均匀隔开的孔以接收驱动缆线。三条缆线就足以将肘节以任何所需的方向弯曲，调节单条缆线上的张力以产生所需的弯曲动作。因为很小的肘节直径和由手术力施加到肘节上的力矩，三条缆线内的应力会很大。通常使用不止三条缆线来降低每条缆线内的应力(包括用于控制目的冗余的额外缆线)。在下述的某些实例中，使用十二条或更多的缆线(参考下面对图4的讨论)。为了驱动缆线，可以使用万向板或摇板。万向板利用两个标准的输入来操纵缆线从而能够相对于倾斜轴和摆动轴以任意角度弯曲肘节。
一些肘节由管状部件制成，该管状部件的柔性足以倾斜和摆动的方式弯曲(例如，图2和图4)。可以包括内部弹簧。该管状部件可以包括缺口以降低结构刚度从而便于弯曲(例如，图5和图19)。一种制造肘节的方法是在中心孔和控制线孔内插入线和海波管(hypotube)芯轴。可以制作一个铸模，然后该机构可以利用在烘箱内(例如，在约165℃)固化的二元铂固化硅橡胶(two-part platinum cure siliconerubber)被过模成型(overmold)。成型后拉出芯轴从而产生通道以形成用来拉扯缆线的中心腔管和周边腔管。通过这种方式，肘节就没有外露的金属部分。橡胶可以承受热压处理，并可以在肘节弯曲期间承受拉伸，该拉伸通常是约30％的应变。
在特定的实施例中，管状部件包括多个轴向滑动部件，每个轴向滑动部件都有一个用于接收驱动缆线的腔管(例如，图8)。管状部件可以由多个轴向弹簧形成，其中这些弹簧的线圈与相邻弹簧的线圈重叠从而形成用来接收驱动缆线的腔管(例如，图10)。管状部件可以由一叠波形弹簧形成(例如，图12)。管状部件内的腔管可以由轴向弹簧的内部形成(例如，图16)。管状部件的外部可以是编织形成的从而提供抗扭刚度(例如，图27)。
A.由绕线支撑的具有线的肘节
图1示出了一个肘节10，其被连接在手术工具的远端末端执行器12和近端工具柄或主管14之间的。所示的末端执行器12包括安装到远端挂钩(clevis)18的夹子16，从图2可以清晰地看出。远端挂钩18包括侧访问槽20用以容纳多条线或缆线24的远端卷丝22，缆线24的近端连着海波管26，该海波管26延伸穿过平台或导向件30，并穿过工具柄14的内部。导向件30对海波管26和线组件定向，并固定到该器械的工具柄14上。当工具柄14以滚动方式运动时，导向件30也可以驱动肘节10的滚动运动。侧访问槽20方便地将卷丝22压住定位。当然，可以在其他的实施例中用其他的方法将线24固定到远端挂钩18上，例如激光焊接。
图2和图3示出了四条线24，但在另一个实施例中可以使用不同数目的线。线24可以由镍钛合金(nitinol)或其他合适的材料制成。线24产生了肘节10的关节，并且被坚固地连接在远端挂钩18和海波管26之间。绕线34以类似于卷簧的形式缠绕在线24上，并在远端挂钩18和海波管26之间延伸。收缩管36覆盖住绕线34和部分远端挂钩18和导向件30。当推拉海波管26使肘节10倾斜和摆动时，绕线34和收缩管36使线24彼此之间保持一个固定距离。它们也向肘节10提供了抗扭刚度和总刚度，使得肘节可以和工具柄14一起滚动并可以抵抗外力。绕线和收缩管可以在其他实施例中设计成不同的形式(一个优选实施例示于图27中，并在下面的J部分中描述)。例如，它们可以变为一个五腔管挤压件(extrusion)，而线24是内部元件。当肘节10滚动、倾斜、和/或摆动时，绕线或等效结构的作用是使线24与中心线保持一个恒定距离。
B.由驱动缆线弯曲的具有柔性管的肘节
图4所示的肘节40包括一个具有孔或腔管43的管42，这些孔分布在圆周的周围以接收驱动缆线或线44，这些缆线可以由镍钛合金制成。管42是柔性的，从而允许通过拉扯缆线44使其以倾斜和摆动的方式弯曲。肘节40优选包括一个刚性的远端终止盘41(如图4B的替换实施例所示)或其他的加强件，该加强件的刚性比柔性管42显著强，从而能够将缆线力均匀地分配到柔性管42。管42的中空中心为末端执行器的缆线(例如抓握缆线)提供了空间。通常具有至少四个腔管。可以一个内部弹簧47。
图4所示的特定实施例的十二个腔管用以容纳六条缆线44，该缆线44在管42远端形成U形转折45。对于使用相同的缆线拉力来获取相同的倾斜和摆动弯曲，使用较多的缆线数目可以使管42具有较大的刚度。例如，用十二条缆线替代四条缆线意味着对于同样的缆线拉力管42的刚度是原来的三倍。可选地，如果保持相同的管42的刚度，用十二条线替代四条线意味着所需的缆线拉力要以系数3来降低。注意，虽然材料性质和缆线的应力级别可以允许U形转折45直接支撑在管42的远端，但也可以包括一个加强的远端终止板41以将缆线力更均匀地分布在管42上。缆线44的近端可以连到一个致动机构，例如一个包括万向板46的机构，其在2002年6月27日提交的专利号为10/187,248的美国专利申请中公开，该申请的全部公开内容在这里以引用方式引入。该机构便于以一种协调的方式来驱动所选择的多条缆线，以控制可弯曲或可操纵的部件，例如控制柔性肘节的弯曲角度和方向。申请10/187,248的致动机构的实例适于以某种合适的方式驱动大量的外围缆线，从而能够协调地操纵柔性部件，而不需要较多的线性控制器。或者，可以使用独立的线性控制致动机构来拉紧每条绕在滑轮上并与旋转致动器一起运动的缆线或缆线对，通过协调多个线性致动器对操纵过程进行控制。
管42通常由弹性模量足够低的塑性材料或弹性体制成，从而允许在倾斜和摆动方向上充分弯曲，并且可以由多腔管挤压件制成从而包括多个腔管，例如，十二个腔管。通常希望该管具有较高的弯曲刚度以限制不需要的变形，例如S形的弯曲，但是这增加了倾斜和摆动方向上的弯曲所需的缆线力。如下面讨论的那样，可以利用比需要的数目更多的缆线(即超过三条缆线)来操纵肘节倾斜和摆动，以提供足够大的缆线力来克服该管的高弯曲刚度。
图4A和图4B示意地示出一个类似于图4所示的肘节实施例内的两种不同缆线布局的一个实例。注意，对于不变的总缆线横截面积，包括成对的缆线和包括较多数目的相应较小缆线都可以使缆线相对于肘节中心线终止在更大的横向偏移位置处。图4A和图4B分别示出了肘节实施例的俯视图和正视图，它们由分界线分开，每个图的右侧所示为肘节实例1，而每个图的左侧所示为肘节实例2。在每个实例中，管42都有相同的外半径R和界定中心腔管的内半径r。
在实例1中，肘节40.1中缆线44的数目为4(n1＝4)，每条缆线都各自终止于远端锚44.5，该远端锚设置在远端终止板41的埋头孔内，每条缆线都延伸穿过各自的横向缆线腔管43，该腔管位于远端终止板41和柔性管42内。远端锚44.5可以是陷型球(swaged bead)或其他常规的缆线锚。
在实例2中，肘节40.2中的缆线44’的数目等于16(n2＝16)，缆线布置成八个对称相隔部分对44’，每对都以远端“U形转折”末端环45终止，该末端环45支撑在相邻缆线腔管43’间的远端终止板41’上。可以对腔管43’开口处远端终止板41’的棱边进行倒圆以降低应力集中，而且末端环45可以部分或全部埋入远端终止板41内。这十六条缆线44’的直径是四条缆线44的直径的1/2，因此在每个实例中缆线的横截面总面积是相同的。
比较实例1和实例2，采用末端环45可以省去缆线锚44.5所需的远端体积，而且能使缆线腔管43’比缆线腔管43离管42的半径R更近。另外，每条缆线44’较小的直径使得缆线中心线更靠近缆线腔管43’的外边。上述两个性质使得实例2中的缆线相对于管42的中心所产生的力臂L2大于实例1的对应力臂L1。对于管42上相同的总弯曲力矩，更大的力臂L2使得缆线应力较低(从而使缆线的使用寿命更长或者可以有更大的缆线材料选择范围)，或者，对于相同的缆线应力可以产生更大的弯曲力矩(从而允许更大的肘节定位刚度)。而且，直径较小的缆线比相对较粗的缆线更加柔性。因此，肘节40的优选实施例包括不止三条缆线，优选地至少六条缆线(例如，三对环形缆线)，而且更优选地包括十二条或更多条缆线。
注意，在远端终止板41处所示的锚或终止点是示例性的，如果所选材料的性质适于所施加的应力，那么缆线可以被终止(通过锚或环)以直接支撑在管42的材料上。或者，缆线可以向远端延伸超过管42和/或远端终止板41，从而通过连接到更远端的末端执行器部件(未示出)而终止，缆线的张力被足够地偏置，以在肘节动作的操作范围内，保持末端执行器可靠地连接到肘节40。
一种从结构上降低管的刚度的方法是提供缺口，如图5所示。管50在两侧包括多个缺口52，而且缺口分别在两个垂直方向上交替出现以便于在倾斜和摆动方向上弯曲。多个腔管54被分布在圆周周围以容纳驱动缆线。
在图6所示的另一个实施例中，管60被制成包着内部弹簧62的外部套管，形成内部弹簧62的材料的刚度大于管60的材料刚度。管60包括内部槽64以接收驱动缆线。提供一个单独形成的柔性管可以简化装配。与具有缆线穿引孔的管比较，这样的一个管更易挤压，或成形。这种管也可以使工具有执行终端结构或锚的驱动缆线，因为可以从中心腔管内将缆线安放到位，然后在缆线内侧插入内部弹簧以保持缆线的间距和固定。在某些情况下，管60可以是经过消毒的单个使用元件，但不必要能够经受热压处理。
图7所示的管70具有缺口72，该缺口72可以类似于图5的管50中的缺口52。管70可以由塑料或金属制成。外壳74位于管70的周围。外壳74可以是Kapton(聚酰亚胺)壳或类似物，其材料通常具有较高的弹性模量，而且外壳具有可以套入缺口72内的皱褶。
C.具有使用轴向舌槽的滑动部件的肘节
图8和图9所示的肘节80具有多个柔性的轴向滑动部件82，这些部件82通过轴向舌槽连接84彼此连接或互锁形成管状肘节80。每个滑动部件82都构成管80的纵向区段。轴向连接84允许滑动部件82彼此之间轴向滑动，而同时能够保持每个部件相对于肘节纵向中心线的横向位置。每个滑动部件82都包括一个用于接收驱动缆线的孔或腔管86，该驱动缆线的终端邻近肘节80的远端。图9示出了在缆线90的缆线拉力的作用下肘节80的弯曲，滑动部件82的滑动能够助于弯曲。缆线90延伸穿过工具柄92，并朝近端连接到致动机构，例如用于致动的万向板94。因为在肘节80弯曲期间滑动部件82的曲率半径不同，所以滑动部件82以不同的程度弯曲。或者，具有轴向滑动部件的肘节的一个实施例可以具有整体式的缆线和滑动部件，例如，从而滑动部件可以作为整体式滑动部件在缆线周围整体地形成(例如，通过挤压)，或者致动机构连接到滑动部件的近端，滑动部件将力直接传递到肘节的远端。
图13所示的肘节130具有多个轴向部件132，该轴向部件132通常由柔性塑性材料制成。轴向部件132可以在缆线134上一同挤出，因此缆线可以是金属的，并仍然分离开。轴向部件132可以通过轴向舌槽连接136彼此连接从而形成管状肘节130。在肘节130在倾斜和摆动方向上弯曲期间，轴向部件132彼此之间可以滑动。肘节130类似于图8的肘节80，但具有稍稍不同的结构，而且组件具有不同的形状。
D.具有重叠的轴向弹簧部件的肘节
图10和图11所示的肘节100由多个轴向弹簧102形成，该轴向弹簧被布置在圆周周围，从而形成管状肘节100。弹簧102为卷簧，这些卷簧以相同方向缠绕，或者更可能地，以相反方向缠绕。缆线104延伸穿过每对相邻弹簧102的重叠区，在图11中可以更清晰地看出。因为重叠的缘故，如果肘节在缆线张力的作用下完全压缩，则肘节100的最大压缩高度将是单个弹簧102最大压缩高度的两倍。通常弹簧102都预加载到压缩状态，因此缆线不会松弛，从而增加了肘节稳定性。
在一个替换方案中，当肘节处于中立(neutral)或未弯曲状态时，通过缆线的预张力弹簧被压到完全压缩的最大压缩高度状态。在肘节一侧可控制地、协调地减小缆线张力或释放缆线会使一侧张开，因此肘节100一侧的弹簧张开从而形成弯曲肘节100的外半径。在外侧重新施加缆线拉力会使肘节恢复到直的结构。
在另一个替换方案中，当肘节处于中立(neutral)或未弯曲状态时，通过缆线的预张力使弹簧被压到部分压缩状态。在肘节一侧可控制地、协调地增大缆线张力或拉扯缆线会使那一侧收缩，因此肘节100一侧的弹簧缩短从而形成弯曲肘节100的内半径。可选地，这可以与在外半径处的张力释放(如上述第一个替换方案所述)组合使用。当恢复初始的缆线拉力时，肘节会返回到直的结构。
E.具有波形弹簧部件的肘节
图12所示的肘节是波形弹簧120的形式，波形弹簧120具有多个波形弹簧区段或组件122，这些组件122堆叠起来或缠绕起来形成管状的波形弹簧肘节120。在一个实施例中，波形弹簧由一条连续的扁平线以类似螺旋状的方式缠绕形成，其中每圈的波形都不同，使得一圈的高点和下一圈的低点接触。这样的弹簧可以购买到，例如，从SmalleySpring Company购得。在波形弹簧肘节120内形成的孔用来接收驱动缆线。或者，多个分离的盘状波形弹簧区段可被珠形焊(strungbead-fashion)到驱动缆线上(由缆线固定或者互相粘合)。
所示的波形弹簧区段122每个都有两个相对的高点和两个相对的低点，这些点以90度隔开。这种结构便于倾斜和摆动方向的弯曲。当然，波形弹簧区段122可以具有其他的结构，例如在肘节120圆周的周围具有额外的高点和低点的更密的波形。
F.具有使用球形配合表面的盘状物的肘节
图14所示的是肘节140的几个区段或盘状物142。内部弹簧144设置在盘状物142的内部空间内，而多个缆线或线145被用于在倾斜和摆动方向弯曲肘节140。盘状物142可以串在或连接在内部弹簧144上，内部弹簧144作为腔管用于拉扯带有末端执行器的缆线。内部弹簧144提供了轴向刚度，因此通过拉扯缆线向末端执行器所施加的力不会使肘节140变形。在替换实施例中，可以用叠制的实心隔板来替代弹簧144以达到这种作用。盘状物142每个都包括外配合曲面146以配合相邻盘状物的内配合曲面148。图15所示的肘节14弯曲伴随着盘状物142间的相对转动。例如，盘状物142可以由塑料或陶瓷制成。优选地，球形配合表面146、148间的摩擦力不应该大到妨碍肘节140运动的程度。一种缓和这种潜在问题的方法就是选择合适的内部弹簧144，在缆线145驱动肘节140弯曲期间，该弹簧144能够承受一些压力载荷从而防止过多的压力载荷加在盘状物142上。内部弹簧144可以由硅橡胶或类似材料制成。附加的硅元件150也可以包围驱动缆线。在替换实施例中，分离的盘状物142可以被一个连续的螺旋带替代。
在替换实施例中，肘节160中每条缆线都容纳在图16和图17所示的弹簧圈162内。也提供了内部弹簧164。盘状物170没有环形外缘和接收缆线的孔(如图14和图15的盘142内的情形)。弹簧圈162内的实心芯轴线172沿着盘状物170的外围放置定位。中心芯轴线174放在中间用以缠绕内部弹簧164。该部件可以由硅树脂或类似材料封装(pot)，然后可移走芯轴线172、174。某种形式的壳或类似组件可以用来防止硅树脂粘到盘状物170的球形配合表面。缠绕小芯轴弹簧172时预留小的间隙(而不是最大压缩高度)，从而当肘节160弯曲时提供收缩空间。硅树脂应充分结合到盘状物170上以向所结合的组件(盘状物170和弹簧172、174)提供抗扭刚度。绝缘的硅树脂材料可以作为烧灼工具的烧灼绝缘，该烧灼工具包括有肘节160。
G.具有被弹性部件隔开的盘状物的肘节
图18所示的肘节180具有多个被弹性部件184隔开的盘状物182。弹性部件184可以是环状部件，或者可以包括多个分布在盘状物182圆周周围的块。类似于图14的肘节140，内部弹簧186设置在盘状物182和弹性部件184的内部空间内，而多个缆线或线188用于在倾斜和摆动方向上弯曲肘节180。盘状物182可以串在或连接到内部弹簧186上，内部弹簧作为腔管用于拉扯带有末端执行器的缆线。内部弹簧186提供了轴向刚度，因此通过拉扯缆线向末端执行器所施加的力不会使肘节180变形。与肘节140比较，肘节180的结构更类似于人体的脊骨。弹性部件184可以弹性变形从而可以使肘节180在倾斜和摆动方向弯曲。使用弹性部件184就不需要盘状物182之间的配合表面，从而避免了相关的摩擦力。
H.具有用交替的肋来支撑盘状物进行倾斜和摆动弯曲的肘节
图19所示的肘节190包括多个盘状物192，该盘状物192由定位在相互垂直的方向上的交替的梁或肋194、196支撑从而便于肘节190的倾斜和摆动弯曲。肘节190可以由管制成，即除去相邻盘状物192间不要的部分以留下相邻盘状物192间基本互相垂直的肋194、196的交替层。盘状物192具有孔198用于使驱动缆线通过其中。盘状物192和肋194、196可以由各种材料制成，例如钢、铝、镍钛合金或塑料。在如图20所示的肘节200的一个替换实施例中，盘状物202包括窄槽204以替代孔来接收缆线。与具有缆线穿孔的管比较，这样的管更容易挤压成形。在盘状物202上缠绕弹簧206以支撑缆线。
在图21中，肘节210的盘状物212由交替的梁或肋214、216支撑，肋在其两侧都有深达盘状物212内的缺口或切口217从而使得肋214、216比盘状物212间的间距要长。对于相同的肘节长度，与图19中的肘节190相比这种结构便于弯成更小的曲率半径，或者便于用较短的肘节获得相同的曲率半径。在这些实施例中，相邻盘状物212间的角度通常是大约15度。盘状物212具有孔218用于接收驱动缆线。
I.利用沿着卷簧分布的薄盘的肘节
图22所示为一个肘节220的一部分，肘节220的卷簧222具有多个沿着卷簧222长度方向上分布的薄盘224。图22的肘节部分仅示出了两个薄盘224A和224B，薄盘224A和224B由彼此互相垂直的舌片226来定位，如图23和图24所示。除了用于在其中插入薄盘224的间隙之外，弹簧222以最大压缩高度缠绕。在邻近薄盘224的内边和舌片226处，弹簧222连到薄盘224。薄盘224可以通过蚀刻形成，包括用以接收驱动缆线的孔228。在肘节220倾斜和摆动弯曲期间，舌片226作为支点使得弹簧222可以在某些位置弯曲。在一些实施例中薄盘224可以相对坚硬，但在另外的实施例中薄盘可以足够柔软以致在肘节220弯曲期间，薄盘能够弯曲并作为弹簧元件使用。可以在卷簧222和薄盘224的周围提供硅树脂外壳作为介质绝缘体。另外，弹簧222和薄盘224可以由外部结构保护，例如，由图25和图26的外壳部分或外部套管部件250形成的。每个外部套管部件250包括外配合面252和内配合面254。一个外部套管部件250的外配合面252与相邻外部套管部件250的内配合面254配合。外部套管部件250沿着弹簧222的长度方向叠制起来，并且在它们因肘节220弯曲而转动时，外部套管部件250仍保持接触。
J.具有外部编织线的肘节
准确地说，柔性肘节取决于各种材料相对于所加载荷的刚度。即，如果所用的材料的刚度越大、和/或肘节的长度越短、和/或肘节的直径越大，那么在所施加的给定手术力作用下，肘节的侧向变形越小。如果拉伸缆线的柔量可以忽略，就可以精确计算出肘节末端的角度，但在一个不能被缆线抵消的力的作用下仍会出现偏斜或横向变形。如果肘节是直的，并且施加这样的力，例如，肘节会呈现S形的变形。抵消这个力的一种方法就是为肘节使用刚度足够的合适材料和合适的几何形状。另一种方法就是使一半的拉伸缆线终止在肘节长度的一半处，然后尽量拉伸剩下的一半缆线，如美国专利申请10/187,248所述的那样。更好地抵抗S形变形需要肘节承受力矩的能力。而另一种避免S形变形的方法使在肘节的外部提供编织外壳。
图27所示的肘节270具有管272，该管272被外部线274缠绕。每个线274都缠绕成可以包括管272两端间大约360度的旋转区间。为增加肘节270的抗扭刚度并避免肘节270的S形变形，外部线274可以缠绕形成管272上的编织外壳。为了形成编织外壳，包括右手组和左手组(即，一个顺时针，一个逆时针)的两组线编织在一起。编结或编织能防止顺时针线和逆时针线相对于彼此发生径向移动。由此产生了抗扭刚度，例如，因为在扭转作用下，一组线的直径将增大而另一组线将缩小。编织可以防止一组线不同于另一组线，因此抵抗了扭转变形。通常希望外部线274的铺设长度等于肘节270的长度，因此当肘节270以圆弧弯曲时，编织的每个线都不需要增加长度，虽然此时需要外部线274轴向滑动。编织线可以抵抗肘节270的S形变形，因为它需要外围线274增加长度。另外，编织线还可以作为外部套管保护肘节不受擦伤或刮伤。如果编织外壳是不导电的，它还可以位于最外层作为肘节270的外部套管。增加肘节的抗扭刚度和避免肘节的S形变形也可以通过层叠的弹簧来实现，层叠的弹簧起始是右手方向缠绕的，然后盖上左手方向缠绕的弹簧，然后再盖上另一个右手方向缠绕的弹簧。这些弹簧不需要编织在一起。
K.肘节外壳
上述公开了某些用于肘节的外部套管和外壳。图28和图29示出肘节外壳的另外的实例。在图28中，肘节外壳280由不导电材料例如塑料或陶瓷制成的平螺旋线。当肘节被弯曲时，螺旋外壳280的不同线圈会在彼此上滑动。图29所示的肘节外壳290包括弯曲或卷曲边292以确保相邻螺旋层之间会重叠。为给肘节提供抗扭刚度，肘节外壳300可以包括平行于肘节轴线的突棱或凹槽302。突棱302作为从一个螺旋层到下一个螺旋层的键，构成用于肘节的扭转稳定机构。还有结构类似支架(stent)的镍钛合金激光外壳。
上面所介绍的装置结构和方法仅为了阐释本发明原理的应用，在不脱离本发明权利要求确定的精神和范围的前提下，可以作出很多其它实施例和变化。因此，本发明的范围不应该参照上述说明来确定，而应该参照所附权利要求即其所有等效物来确定。

Claims (16)

1.一种医疗器械，其包括：
一个柄，其具有一个远端部分和一个近端部分；
一个肘节，其具有一个近端部分和一个远端部分，所述肘节的近端部分连接到所述肘节的远端部分，所述肘节包括：
一个柔性管状支撑部件，其从所述肘节的所述近端部分延伸到所述肘节的所述远端部分；以及
一个包裹在所述支撑部件周围的外部层，所述外部层具有比所述支撑部件的硬度更低的硬度，所述外部层包括至少三个腔管，所述腔管从所述肘节的所述近端部分延伸到所述肘节的所述远端部分；
所述器械进一步包括至少三条驱动缆线，所述缆线中的每一条缆线从所述肘节的远端部分穿过所述至少三个腔管中的一个对应腔管到所述肘节的远端部分。
2.根据权利要求1所述的器械，其中所述支撑部件是弹簧。
3.根据权利要求1所述的器械，所述至少三条驱动缆线中的每一条缆线进一步从所述肘节的近端部分穿过所述柄到所述柄的近端部分，所述器械进一步包括连接到所述柄的近端部分的驱动机构，所述机构包括至少三个旋转驱动器，所述驱动器连接到所述至少三条驱动缆线中的对应缆线。
4.根据权利要求3所述的器械，其中所述管的操纵通过协调所述旋转驱动器的驱动进行控制。
5.根据权利要求3所述的器械，所述肘节进一步包括末端执行器腔管，所述器械进一步包括：
一个末端执行器，其被连接到所述肘节的远端部分；
至少一个末端执行器控制元件，其被连接到所述末端执行器，所述末端执行器控制元件从所述末端执行器穿过所述肘节的末端执行器腔管穿过所述柄到所述柄的近端部分；
一个末端执行器控制机构，其被连接到所述末端执行器控制元件，所述末端执行器控制机构被连接到所述柄的近端部分。
6.根据权利要求5所述的器械，所述末端执行器控制元件包括驱动缆线，并且所述末端执行器控制机构包括连接到所述驱动缆线的旋转驱动器。
7.根据权利要求6所述的器械，所述末端执行器包括钳子，所述末端执行器控制元件包括抓握缆线，所述末端执行器控制机构包括所述抓握缆线。
8.根据权利要求5所述的器械，所述末端执行器包括电极，并且所述末端执行器控制元件包括电导体。
9.根据权利要求1所述的器械，所述驱动缆线被配置成使所述肘节的远端部分相对于所述肘节的近端部分关于摆动轴和倾斜轴弯曲，所述摆动轴与所述倾斜轴交叉。
10.根据权利要求1所述的器械，所述肘节的远端部分被连接到终止元件，所述至少三条驱动缆线中的每一条缆线被插入穿过所述终止元件中的对应孔。
11.根据权利要求10所述的器械，所述终止元件包括一个刚性盘。
12.根据权利要求10所述的器械，所述终止元件包括一个环。
13.根据权利要求1所述的器械，所述肘节包括至少一个间隙。
14.根据权利要求13所述的器械，所述至少一个间隙包括在至少两个垂直方向上交替的多个缺口。
15.根据权利要求14所述的器械，其中所述缺口位于所述柔性支撑部件中。
16.根据权利要求14所述的器械，其中所述缺口位于所述外部层中。
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