CN1794944A - 一次性使用的内窥镜成像系统 - Google Patents
一次性使用的内窥镜成像系统 Download PDFInfo
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Abstract
一种内窥镜成像系统包括可反复使用的控制柜,该控制柜具有控制与之连接的轻型内窥镜方位的多个致动器。内窥镜用于单个病人,而后丢弃。该内窥镜包括照明机构、图像传感器和其中具有一个或多个腔管的细长轴。在内窥镜末端处的铰接关节使远侧末端能够由控制柜中的致动器定向。内窥镜涂覆有能减少其摩擦系数的亲水性涂层,且由于其是轻型的,只需较小的力就能将其推进到病人体内所需位置处。
Description
技术领域
本发明一般涉及医疗器械,尤其涉及治疗和诊断内窥镜。
背景技术
作为疾病早期检测的辅助工具,公认由定期的内窥镜体内结构检查能获得较大的公共卫生益处,体内结构比如是消化道和气道,例如食道、肺、结肠、子宫和其它器官系统。用于这种过程的常规成像内窥镜包括具有光纤光导的柔性管,该光导将照明光从外部光源引导到远侧末端,照明光在远侧末端射出内窥镜并照射待检查的组织。通常,还包含另外的光学组件以调整光射出维纤束和远侧末端的速度。物镜和光纤成像光导与位于内窥镜近端处的照相机或位于远侧末端处的成像照相机芯片通信,生成显示给检查者的图像。此外,大多数内窥镜包括一个或多个工作通道,医疗器械,如活检钳、勒除器、电灼探头或其它工具可从该通道中通过。
穿过复杂曲折路径的内窥镜导航对于成功地以对病人产生最小的疼痛、副作用、危险或镇静而进行检查是至关重要的。为此目的,现代内窥镜包括使内窥镜远侧末端弯曲的装置,从而使远侧末端顺应被检查结构路径,在周围组织上产生最小弯曲或摩擦力。类似于木偶线的控制线缆装在内窥镜体内以将远端的柔性部分连接到近侧内窥镜手柄处的一组控制旋钮上。通过操纵控制旋钮,检查者通常能够在插入期间操纵内窥镜并将它引导到感兴趣区域,尽管这种传统控制系统是不灵活的、非直觉的和受摩擦限制的,从而具有局限性。普通操作者对传统内窥镜的报怨包括其有限的柔性、有限的柱强度和沿内窥镜长度上的有限的操作者硬度控制。
常规内窥镜是贵重的医疗设备,内窥镜的花费在$25,000范围内,相关的操作者控制台花费更多。由于上述费用的原因,这些内窥镜制造成能承受反复消毒并用于许多病人。常规内窥镜通常由坚固的材料制成,这会降低内窥镜的柔性,从而可减少病人的舒适性。此外,常规内窥镜是复杂和易损坏的仪器,由于在使用期间或消毒过程期间发生损坏而常常需要昂贵的维修。为克服这些和其它问题,需要一种低成本成像内窥镜,其可用于单个过程而后丢弃。该内窥镜应当比目前能够获得内窥镜具有更好的导航和跟踪,与操作者的优越界面,通过减少内腔组织上的摩擦力而改进接近性,增加病人的舒适度,以及更大的临床生产率和病人容许量。
发明内容
为解决现有技术中的这些和其它问题,本发明提出一种内窥镜视频成像系统。该系统包括一个控制柜,该控制柜包含多个控制内窥镜方位的致动器和一个生成由内窥镜远端的图像传感器采集的组织图像的成像系统。一次性使用的内窥镜可与该控制柜连接并用于检查病人。在检查过程之后,将内窥镜从控制柜上拆下并可丢弃。
本发明的一次性使用内窥镜包括柔性细长管或轴和将光引导到组织样本上的照明光源。位于或邻近内窥镜远端的图像传感器和物镜组件捕获反射光以生成被照明组织的图像。由传感器生成的图像传送到显示设备由检查者观察。在一个实施例中,在内窥镜远端处的成像组件包括廉价且易于组装的元件组,该元件组包括一个或多个发光二极管(LED)、图像传感器如CMOS固态图像传感器和透镜组件。LED热耦合到热交换器上,热交换器由空气或液体进行冷却以去除由LED产生的过多热量。
本发明的一次性使用的内窥镜还包括操纵机构,如多个拉伸控制线缆,其允许内窥镜远端向所需要的方向偏转。在本发明的一个实施例中,拉伸控制线缆的近端与控制柜内的致动器通信。独立操纵杆或其它导向控制器产生电控制信号,该电控制信号由控制柜内的处理器发送以计算该信号来驱动致动器,以将内窥镜远端定位在检查者所需要的方向中。在本发明的另一个实施例中,基于来自图像传感器的图像分析自动操纵内窥镜的远端。操纵杆或其它导向控制器可包括触觉或其它感应反馈以警告操作者内窥镜可能打卷或抵靠到组织壁上。
在本发明的一个实施例中,内窥镜包括铰接关节,该铰接关节包括多个低成本、易于组装的零件,这些零件允许内窥镜远端受控制线缆控制弯向所需的方向。在本发明的一个实施例中,铰接关节施加恢复力,从而当释放拉伸力时,内窥镜远端将会变直。
在本发明的另一个实施例中,内窥镜沿其长度具有硬度变化,其使远端相对更易弯曲,而内窥镜更近端区域具有增加的柱强度和扭距保真度,从而医生能够极容易地、准确地和较少误推进地(“打卷”)扭动和推进内窥镜。可通过改变构成内窥镜轴的材料的硬度等级来提供沿长度上的硬度变化。操作者可控的可变化硬度可通过控制线缆来提供,控制线缆可收紧或放松以调整轴的硬度。在另一实施例中,选择构成铰接关节的元件之间的间隙以提供沿铰接关节长度上的硬度变化。
在本发明的又一实施例中,内窥镜套有可缩回套筒,该套筒在内窥镜使用期间露出内窥镜远端,而在将内窥镜从病人取出后伸出套在远端。
在本发明的另一实施例中,内窥镜涂覆有亲水涂层以减少其摩擦系数。
附图说明
本发明的上述方面和许多附带的优点将通过参照下面结合附图而进行的具体描述而变得更为易于理解和明白,附图中:
图1A和1B是根据本发明的内窥镜成像系统的示意图;
图2进一步示出图1A所示内窥镜成像系统中所采用的一次性使用内窥镜的详细结构;
图3A是与根据本发明实施例的一次性使用内窥镜连接的控制柜的框图;
图3B是与根据本发明另一实施例的一次性使用内窥镜连接的控制柜的框图;
图3C是根据本发明另一实施例的控制柜的框图和一次性使用内窥镜;
图3D是图3C所示的一次性使用内窥镜射流图;
图3E示出用于本发明一次性使用内窥镜实施例的柔性腔管;
图4A示出在控制柜上用于连接到一次性使用内窥镜的连接器的实施例;
图4B-4D示出用于将一次性使用内窥镜的近端连接到控制柜的连接器的实施例;
图4E示出带有用于连接到一次性使用内窥镜的连接器的控制柜的另一个实施例;
图5A是用于本发明内窥镜成像系统的手持控制器的一个实施例的详细视图;
图5B示出操纵杆型控制器,其包括用于本发明内窥镜成像系统的力反馈机构;
图5C示出用于向图5B所示类型的操纵杆提供力反馈的机构的一个实施例;
图5D和5E示出本发明断接盒和手持控制器的另一个实施例;
图6A示出根据本发明的一次性使用内窥镜远侧末端的实施例;
图6B-6I示出用于本发明一次性使用内窥镜的成像组件的实施例;
图7示出用于使多个控制线缆终止于成像内窥镜远侧末端的一个机构;
图8示出具有控制线缆的一次性使用内窥镜,其中控制线缆穿过内窥镜轴壁内的腔管走线;
图9A和9B示出使控制线缆从内窥镜轴的中央腔管到铰接关节内的控制线缆腔管走线的过渡引导机构;
图10A和图10B示出根据本发明实施例的内窥镜轴部结构;
图11示出了一个机构,该机构用于提供沿其长度而具有变化硬度的轴;
图12A和12B示出用于形成根据本发明实施例的铰接关节的突出结构;
图13示出根据本发明实施例的铰接关节;
图14和15示出具有不同硬度区域的突出结构,其用于形成根据本发明另一个实施例的铰接关节;
图16A和16B示出根据本发明实施例的铰接关节的另一个实施例,其包括多个球窝部分;
图17A-17D示出用于形成铰接关节的球和球窝部分的各种可能的结构;
图18A-18B示出根据本发明另一个实施例的由多个堆叠盘形成的铰接关节;
图19A-19B示出根据本发明另一实施例的用于形成铰接关节的盘;
图20A-20B示出根据本发明另一实施例的用于形成铰接关节的盘;
图21A-21B示出根据本发明另一实施例的用于形成铰接关节的非圆形段;
图22示出根据本发明另一实施例的具有作为铰接关节的编织件的内窥镜;
图23示出用于将控制线的端部固定到图22所示的编织铰接关节上的一种可能的技术;
图23A-23X示出用于本发明一次性使用内窥镜的铰接关节的其它实施例;
图24示出根据本发明另一实施例的具有一个或多个记忆降低缠绕物的内窥镜轴;
图25示出根据本发明另一实施例的包括高硬度材料的纵向带条的内窥镜轴;
图26-29示出旋转根据本发明的一次性使用内窥镜的抓握机构的可替换实施例;
图30A和30B示出根据本发明另一实施例的可选择地覆盖在一次性使用内窥镜上的可缩回套筒;
图31示出根据本发明的一次性使用内窥镜无源散热远侧末端的实施例;以及
图32和33示出根据本发明的无源散热远侧末端的可替换实施例。
具体实施方式
如上所述,本发明是一种使医生能够观察病人内部体腔以及将手术器械插入病人体内的内窥镜视频成像系统。本发明所采用的成像内窥镜制造成本极其低廉,从而该内窥镜可考虑作为一次性使用的一次性产品。
如图1A所示,根据本发明一个实施例的内窥镜视频成像系统10包括一次性使用的成像内窥镜20、控制柜50和手持控制器80。一次性使用内窥镜20具有插入病人体腔内的远侧末端22和连接到控制柜50上的近端24。如将在下面更为详细描述的,控制柜50包括多个致动器,这些致动器控制内窥镜20内的操纵机构以改变远侧末端22的方位。医生或他们的助手采用手持控制器80输入移动内窥镜20远侧末端22的控制信号。此外,控制柜50可包括与空气/气体源和冲洗液体源如用于清洗内窥镜20的水源的连接。控制柜50还可包括成像电子器件以生成和/或将从图像传感器接收的图像和其它病人数据传送到由医生或技术人员观察的视频显示器(未示出)上。
在所示出的实施例中,一次性使用的内窥镜20还包括放置在沿内容镜长度上靠近中间位置处的断接盒26。断接盒26提供工作通道的入口并可包括真空采集瓶40的附着点,真空采集瓶40采集从内窥镜腔管接收的液体或碎片。真空采集瓶40由放置在断接盒26上的真空阀28控制。可替换地,真空阀可放置在控制柜50内并由手持控制器80控制。
如果需要,手持控制器80可固定到断接盒26上,从而这两个单元可作为一个移动。当完成病人检查过程时,将一次性使用内窥镜20从控制柜50上脱开并丢弃。而后将新的一次性使用内窥镜20连接到控制柜50上以供进行下一次检查过程。
图1A所示的实施例是“并联”结构,其中内窥镜20和手持控制器80分开插入控制柜50的不同连接器上。该并行结构允许一个操作者拿着内窥镜,而另一个操作者可操纵手持控制器80。可替换地,手持控制器80可固定到内窥镜20上,从而单个操作者就可控制二者。图1B示出本发明的“串联”结构。此时,一次性使用内窥镜20通过手持控制器80连接到控制柜50上。
图2示出一次性使用内窥镜20的一个实施例更详细结构。在内窥镜近端处是低扭距轴24和将内窥镜20连接到控制柜50上的连接器34。断接盒26远侧是较高扭距轴。在内窥镜20的远端处是远侧末端22,其包括光照明端口、图像传感器、工作通道的入口和冲洗端口(未示出)。远侧末端22的近侧是铰接关节30,其为轴远侧部分提供足够的柔性,从而远侧末端可由操纵机构引导在所需的偏转范围(180°或更大)偏转,并且可受引导以在远侧末端周围任何所需的方向弯曲。也就是说,操作者可选择弯曲量或铰接量和弯曲方向。
如上所述,根据本发明一个实施例的一次性使用内窥镜20,在内窥镜远侧部分具有较高扭距轴,而在其近端具有较低扭距轴。沿内窥镜轴长度放置的断接盒26可用作手柄或抓握器以在医学检查过程中施加内窥镜远端的转动。轴的较高扭距部传递在靠近远侧末端位置处施加的旋转运动以引导内窥镜远侧末端。内窥镜的较低扭距轴部分不传递扭距且易于操纵,并在施加旋转运动时可发生扭曲。
在使用时,医生可将医疗器械,如活检钳、勒除器等插入到在断接盒26上形成的内窥镜工作通道入口内。在可替换实施例中,工作通道腔的入口可位于进一步靠近内窥镜近端处。
图3A是包括在控制柜50的一个实施例内的主要元件的框图。控制柜50优选安装在轮子上,从而其在检查过程之前可易于放置在病人附近。控制柜连接到电源上,即可以是交流电源也可以是电池,控制柜还连接到吹入气体源和灌注液体源上。在控制柜50内部是连接到手持控制器80并从其接收控制信号的控制接口52。为改变内窥镜远侧末端的方位,从手持控制器80中的导向开关接收控制信号。该控制信号提供到伺服电机控制器54,该伺服电机控制器54依次控制多个致动器如伺服电机56a、56b、56c、56d。每个伺服电机56a-56d连接到内窥镜内的一个或多个控制线缆。伺服电机56a-56d的运动拉伸或释放控制线缆以改变内窥镜20远侧末端22的方位。虽然图3A所示实施例示出四个伺服电机和控制线缆,可以理解,可采用更少或更多的伺服电机和相应的控制线缆来移动远侧末端。例如,一些内窥镜可采用三个控制线缆和三个相关的伺服电机或带四个控制线缆的两个伺服电机。
成像电路板60接收从一次性使用内窥镜远侧末端处的图像传感器(未示出)和其相关电子元件发出的信号。在将图像显示在视频显示器(未示出)上之前成像电路板60可增强所接收的图像或可提供视频效果,如缩放、颜色改变、高亮等。组织图像还可由成像电路板60和/或单独的处理电路进行分析以产生提供到伺服电机控制器54的控制信号,从而自动操纵内窥镜远侧末端,就如后面将要进一步详细描述的那样。由成像电路板60生成的图像还可在数字打印机上打印、发送到网络服务器或存储、保存到计算机可读介质上,如软盘、CD、DVD等,或存储、保存到录像磁带上供医生以后回放和分析。
成像电路板60还向光源如在成像内窥镜远侧末端22处的多个发光二极管(LED)提供电源。可替换地,如果内窥镜采用外部光源,则运动控制柜可包括向成像内窥镜20内的光纤照明引导装置提供光的强光光源,如激光或弧光灯光源,以照明体内器官。当用户需要启动光源或调整所产生的光强时,可通过从手持控制器80接收的信号控制任一电源58。
最后,控制柜50包括阀70,阀70控制吹入空气/或气体的输送以向病人体内吹气和灌注液体的输送以冲洗体腔和/或清洁内窥镜远侧末端处的成像光源和图像传感器。吹入的空气/气体和灌注的液体通过连接至内窥镜20的灌注/吹气腔管上的连接器38连接到成像导管上。在本发明的一个实施例中,灌注和吹气腔管是成像导管中的同一腔管。然而,应当理解的是,如果需要且如果内窥镜内空间允许的情况下,可提供分开的灌注和吹气腔管。
图3B示出类似于图3A所示控制柜的另一个控制柜实施例50A。控制柜50A包括对输送至真空采集瓶40的真空进行控制的真空阀71。真空管线73连接到成像内窥镜20内的真空腔管。真空阀71由手持控制器80控制。
图3C示出根据本发明的一次性使用内窥镜成像系统的另一个实施例。内窥镜成像系统100包括控制一次性使用内窥镜104的方位和功能的控制柜102。控制柜102包括接收来自由医生或他们的助手用来控制一次性使用内窥镜所用的输入设备,如操纵杆的命令的控制器接口106。来自操纵杆的命令提供到可编程处理器,如数字信号处理器,处理器控制成像系统和伺服控制单元108的全部操作。处理器和伺服控制单元控制一对依次驱动内窥镜104内控制线缆的伺服电机110、112的操作。相应于从用户输入设备接收的导向信号和从传感器获得的反馈信号控制远侧末端的方位,其中传感器测量每个伺服电机110、112的位置和扭距。
在本发明的一个实施例中,处理器和伺服控制单元108实行位置-速度控制,其使远侧末端所移动的速度作为用户输入设备上的导向开关的位置的函数进行变化。然而,也可实行其它控制算法,如位置-位置或位置-力(即加速度)。
由处理器和伺服控制单元108完成的另一个功能是生成在视频显示器上显示给用户的近似的末端关节的图形表示。处理器接收关于伺服电机位置的反馈信号,由此确定控制线缆缩短的长度和移动线缆所需要的扭距。从这些值得出内窥镜远侧末端处关节数量近似值。近似的关节量和关节方向与从图像传感器接收的图像、病人数据和/或其它内窥镜成像系统的操作参数一起显示给医生。
处理器和伺服控制单元108还执行允许由医生在病人体内移动远侧末端而向后驱动伺服电机110、112的可变制动功能。该可变制动可由医生或处理器选择可变制动阈值来完成,该可变制动阈值的范围在0和可由电机提供的最大扭距之间。当医生移动内窥镜时,检测电机上的扭距以观察其是否大于或等于可变制动阈值。如果是这样,处理器和伺服控制单元108控制一个或两个伺服电机110、112,从而将末端移动到新位置以使电机的扭距读数小于可变制动阈值。
在有些情况下,如靠近病人身体构造的精细部,会将可变制动阈值设置得较低,从而需要很小的压力来向后驱动电机。在另一些情况下,在需要保持内窥镜中手的形状以供导航等的地方可将制动阈值设置得较高。
控制柜102还包括接收来自一次性使用内窥镜104远侧末端处图像传感器的信号以生成图像的成像板114。成像板114将来自CMOS图像中的数字视频信号进行解串处理并执行所需的算法,如解嵌合、增益控制和白平衡,以生成高质量彩色图像。系统的增益控制通过调整照明强度(供应至LED的电流)和调整至CMOS成像器的RGB增益而实现。成像板114还包括防止病人在发生成像板114上或控制柜102内部的电路故障时受到电击的绝缘电路,以及用于将控制信号发送到图像传感器和从图像传感器接收图像信号的电路。在本发明的一个实施例中,在标准PC电路板上设有成像板114以使各内窥镜能够由个人计算机测试且无需另外的控制柜102。
在图3C所示实施例中,一次性使用内窥镜104具有通过回转接头124连接到断接盒122的远侧轴部120。此外,轴的近侧部126通过第二回转接头128连接到断接盒122。回转接头124、128允许内窥镜的远端和近端相对于断接盒122转动且无需在医生或他们的助手的手中扭转断接盒122。
在所示出的实施例中,一次性使用内窥镜104通过连接器130连接到控制柜102。在连接器130内是一对可与伺服电机110、112的驱动轴接合的线轴132、134。每个线轴132、134驱动一对相反方向的控制线缆。一对控制线缆在上下方向上驱动内窥镜的远侧末端,而另一对控制线缆在左右方向上驱动内窥镜的远侧末端。
连接器130还包括控制内窥镜104内各种管道或腔管的液体、空气和真空供应的总管140。此外,连接器130包括与控制柜102上相应电子连接器配合电子连接器142。连接器142向图像传感器和热传感器发送信号,并从图像传感器和热传感器接收信号,还向照明LED提供电源。由泵145向内窥镜提供水。泵145优选为使水流过延伸进近侧连接器130的柔性管的蠕动泵。由于蠕动泵的泵部件不需要与内窥镜内的水或其它液体接触且允许弄湿的部件一次性使用,因而蠕动泵是优选的。连接到泵145的贮水器150供应冷却照明LED和灌注病人的水。用于冷却LED的水返回闭环中的贮水器150。用真空管线从病人身上清除废水或其它碎片并将其装入采集瓶160。在近侧连接器130内的总管140处提供对抽吸到采集瓶160的真空控制。
图3D是图3C所示一次性使用内窥镜104的射流图。如上所述,采用水源150如一袋消毒过的水或盐水利用蠕动泵142向内窥镜供应水。水被泵入将水输送至连接到LED照明源的热交换器的管162。从热交换器返回的水被管164接收并经过流量计166返回贮水器150。在本发明当前实施例中,将水连续泵过热交换器以防止照明源在病人体内变得过热。如果水未被泵过热交换器,则流量计166就提供一个信号,从而医生可决定从病人身上取出内窥镜。
除提供冷却外,水可有选择地施加到提供用于灌注病人体腔的高压灌洗的管170,以及施加到用于清洗内窥镜远侧末端处成像透镜前面的污染物的透镜冲洗管172。如果需要,水也可有选择地施加到连接至内窥镜工作通道管以清洗工作通道所用的管174。每个管170、172、174的水流可由相关的阀进行有选择地控制,如果需要,阀允许水被泵过所述管。如果需要,阀180对内窥镜内的工作通道抽真空以去除灌注液体、碎片或其它来自病人的污染物。阀182向吹气腔管供应空气或其它生物相容气体,在本发明的一个实施例中,吹气腔管与内窥镜远侧末端处的透镜冲洗管172是同一管。利用与调节器一致的电磁阀184、186、188将空气以各种压力提供给病人,电磁阀184、186、188以不同压力提供空气且并联连接到空气或气体源上。输送到透镜冲洗管172的空气压力可通过有选择地打开阀184、186、188的一种组合来调整。止回阀189与空气供应管线一致以防止来自内窥镜的空气或液体回流到空气输送机构中。
图3E示出总管140的一个实施例,其将空气、水和/或真空引导到内窥镜内不同的管或腔中。在本发明的一个实施例中,该总管由两片热塑材料如聚亚胺酯形成,该热塑材料由RF焊接或以其它方式进行结合以在两片之间形成一系列通道。在通道上放置有夹紧阀,其可有选择地打开或关闭以控制液体、空气或真空向内窥镜内不同管的输送。在一个实施例中,总管140在一侧具有三个连接器,而在另一侧具有六个连接器。在一侧,连接器190接收来自贮水器150的水。连接器192连接到使水从远侧末端处的热交换器返回到贮水器150的管,而连接器194连接到与真空源一字排列的采集罐160。夹紧阀是优选的,因为夹紧阀的部件不需要与内窥镜内的水或其它液体接触且它们允许弄湿的部件一次性使用。
在总管的另一侧,连接器196连接到工作通道以向工作通道供应水或供应真空。连接器198连接到透镜冲洗管。连接器200连接到内窥镜内的高压灌洗管。连接器204和206连接到向冷却LED照明源的热交换器供应水和使水返回的管子。
进入连接器190处总管的水可以流向四个不同路径。流过三个路径的液体由在总管通路上位置208、210、212处夹紧总管140的电磁阀有选择地控制。在本发明的本实施例中,水一直泵过热交换器以冷却LED照明源。通过有选择地启动位置208、210、212处的电磁阀,可将水供应到内窥镜内其它的管中。
此外,总管140包括保持连接器196和194之间通路开放的管子或吸管状结构,从而当释放连接器194和196之间位置214处的电磁阀时,抽真空不会使总管140塌陷。所述管子或吸管还包括至少一个孔(未示出)以允许液体流入工作通道。将管子穿孔,从而如果需要,水可以流入工作通道。
在使用后,将总管140从供应水和真空等的管子上取下,且与一次性使用内窥镜的其余部分一起扔掉。柔性总管袋140形成一个低廉的装置,其控制液体或空气向内窥镜的施加,同时防止液体与内窥镜成像系统本身的非一次性部分接触。图4A示出在进行内窥镜检查之前将一次性使用内窥镜的近端固定到控制柜250上所用的连接器的一个实施例。控制柜250上所用包括具有多个轴254的外部连接器252,轴254耦合到图3A和3B中所示类型的伺服电机上。每个轴254的形状制成能容纳在控制线缆缠绕在其上的相应线轴内。连接器252还包括吹气和灌注阀256以及真空阀258的接头以向内窥镜供应空气、水和真空。
图4B和4C示出用于将内窥镜20的近端固定到控制柜250上的连接器260的一个实施例。连接器260包括多个使连接器260能够易于固定到控制柜250外部的外部连接器252上的翼形螺钉262或其它快速释放机构。如图4C所示,连接器260包括多个在其上缠绕有控制线缆的线轴262。每个线轴优选具有螺纹或凹槽以防止控制线缆在使用期间粘在线轴上。盖件265包围线轴的一部分以保持控制线缆抵住线轴并保持在凹槽内,且有助于将线轴支撑在连接器260内。在本发明的一个实施例中,当连接器不与控制柜250接合时,通过将制动器266的销插入线轴相应的槽内来防止线轴转动并从而防止线缆松开。一旦连接器260安装到控制柜250上,制动器266从线轴上脱开,从而线轴可由伺服电机带动。夹子267可用于将近端固定到覆盖在控制线缆的护套上。在连接器260的侧面或在连接器260的后面有光源和图像传感器的电连接接头以及空气和水阀接头以与这些阀接合,如图4A所示。
图4D示出装配在具有花键孔的线轴262内的花键轴254的剖视图。轴254由其中具有弹簧258的圆筒256支撑,从而轴254可以圆筒256内自由运动。圆筒256耦合到控制柜内的伺服电机上。弹簧258允许轴254浮动从而当连接器连接接到控制柜250时,轴可更容易地与线轴262的配合表面对准和接合。
当轴254插入到线轴262内时,制动器266释放,从而允许线轴由圆筒256的旋转而带动。在一些情况下,可省略制动器266,从而当连接器260不与控制柜250接合时,允许线轴262自由转动。
图4E示出具有显示器282的控制柜280的另一个实施例,在显示器282上显示有包括病人数据和由内窥镜生成的视频或静止图像的图像用户界面。在控制柜280的外部设置有连接器284以用于连接一次性使用内窥镜。连接器284包括多个与控制柜内伺服电机耦合的轴286。设置有多个夹紧阀288以控制流过总管的空气、水和真空的流量,总管将贮液器、真空源和空气源(未示出)连接到内窥镜的管子上。设置有蠕动泵290以将液体泵过一次性使用内窥镜,如上所述。操纵杆手持控制器292连接到控制柜280,从而操作者可输入与一次性使用内窥镜的操作及其方位有关的命令。
图5A示出位于根据本发明的手持控制器300的一个实施例上的各种控制装置。手持控制器300包括控制器本体302,其在本发明的类似实施例中通过电缆304耦合到控制柜上;无线射频通道;红外或其它光学连接部。如果通过电缆进行连接,在控制器的电缆304和控制器本体302的接合处设置应变消除装置86以限制电缆304内的电线的弯曲。在本发明的系列实施例中,手持控制器300与控制柜的连接通过导体形成,该导体包括向运动控制器和成像系统发送信号的电线,以及运送吹入空气/气体和灌注液体的腔管。此外,内窥镜的控制线缆通过手持控制器300与和运动控制柜中的致动器相连的线缆相接合。
在手持控制器300上按照人机工程学布置设置多个电子开关。关节操纵杆308或其它多位置设备可向多个方向移动以使医生能够向所需的方向引导成像内窥镜的远侧末端。为手动引导成像内窥镜,医生在观看视频监视器或通过用另一种医学成像技术如荧光透视法观察远侧末端的位置的同时,移动操纵杆308。当采用移动操纵杆308使内窥镜远侧末端朝向所需方向时,医生可推、拉和/或扭转内窥镜以引导远侧末端朝向所需方向。
设置有照相机按钮以拍摄其中放置有一次性使用内窥镜放置的体腔或器官的图像。所采集的图像可以是静止图像或视频图像。这些图像可在显示或存储到可记录介质上之前进行对比度调整或者图像增强。
灌注按钮312启动灌注源通过一次性使用内窥镜的灌注腔管提供如水之类的液体。液体用于清洗内窥镜远侧末端处的图像传感器和/或光源前面的窗口以及体腔区域。设置吹气按钮314用于启动吹气源以通过内窥镜的腔管供应空气/气体。供应的吹入气体使内窥镜远侧末端周围的体腔部分膨胀,从而医生能够更容易地推进内窥镜或更好地看见内窥镜前面的组织。
在本发明的一个实施例中,手持控制器300的本体302还包括如翼形螺钉316之类的可拆连接以用于将手持控制器300固定到如上所述的断接盒上。在断接盒上的相应槽或一组螺纹容纳翼形螺钉316以将两部分连接在一起。如果需要,还可设置一个或多个另外的按钮318以启动其它功能,如记录、打印图像、调整光强、启动真空控制阀或在控制线缆上提供可变化的制动拉力,该控制线缆提供远侧末端的上、下、左、右运动。
图5B示出手持控制器的另一个实施例,操作者用该手持控制器可输入命令以控制控制柜和一次性使用内窥镜的操作。控制器350包括符合人机工程学形状的手柄352以使用户能够用他们的姆指和/或其它手指控制这些操作。操纵杆354位于控制器250的顶部从而用户可以通过用他们的姆指移动操纵杆来操纵内窥镜。多个控制按钮356可由用户的姆指或其它手指启动以控制内窥镜的其它操作,如向内窥镜腔管内供应用于吹气的空气或水/真空、调整照明源强度等。控制器350还包括力反馈机构360,其向偏压操纵杆354的弹簧施加可变化的力。反馈机构360施加的力与操纵内窥镜所需扭距成正比改变。例如,内窥镜可放置成抵住组织壁,或可沿其长度上具有若干圈。因此,可通过由反馈机构360改变施加在弹簧362上的力来给予用户操纵内窥镜所需力的触觉指示。
如上所述,在本发明的一个实施例中,伺服电机执行位置-速度控制算法,由此将操纵杆354的位置转换成远侧末端在所需方向上的位置改变速度。因此,当用户向任何方向压下操纵杆时,由力反馈机构360向弹簧362施加的返回力可以作为移动控制线缆所需扭距的函数而变化,而且改变弹簧上的力还改变该弹簧施加到操纵杆上的力。用户通过操纵杆感受弹簧施加到操纵杆上的力,并且该力给予用户使远侧末端向用户所命令的方向移动所要施加力的水平的触觉指示。
图5C示出提供手持控制器350内力反馈机构360的一个机构。在操纵杆内是驱动齿条和小齿轮机构的电机370,齿条和小齿轮机构包括直接与电机370耦合的第一齿条372和直接与预拉紧弹簧362耦合的第二齿条374。电机370的转动驱动螺杆型机构(未示出)使第一齿条372上下运动。小齿轮传动装置376将第一齿条372的纵向运动转换成第二齿条374的纵向运动,第二齿条374再调整弹簧362上的预拉紧。在所示出的实施例中,由于操纵杆相对于手持控制器350的纵轴线定位,因此需要两个齿条。然而,如果操纵杆在手持控制器内被不同定位,则可采用其它结构。
类似地,可完全采用塑性材料来代替弹簧,且可向塑性材料区域施加力以产生使塑性材料接触和偏压操纵杆的类似作用力。这样,塑性材料就象液压液体一样将力从一个位置传递到另一个位置。然而,与液压液体不同,塑性材料避免了液体处理和保证液体密封的问题。类似地,可使可变扭距电机直接与操纵杆耦合且电机的扭距根据控制线缆的拉紧度调整以直接通过操纵杆将力传递给用户。使用两个电机,使电机作用在操纵杆运动的两个正交轴线上,可以相应于操纵杆运动的所有可能的方向生成力反馈信号。这种直接驱动电机的使用和布置可类似地用于远侧末端的反馈位置。在这种布置中,可采用由位置控制电机来代替由扭距控制电机。控制线缆的位置或驱动这些线缆的伺服电机的位置用于计算远侧末端的近似位置。驱动位置控制电机以使操纵杆位置跟随远侧末端的计算位置。如果操作者试图移动末端且末端的运动被其周围环境所阻塞,则操作者的操纵杆移动将会被位置控制电机所施加的力阻挡以使操纵杆位置与末端位置一致。
虽然所示出的实施例公开了一种电机和齿条和小齿轮传动系统以改变偏压操作杆354的弹簧362的压缩,可以理解,可采用包括液压或磁致动器在内的其它机构。可替换地,可采用拟液装置,如热塑性材料。通过有选择地压缩热塑性材料,可改变其弹性并可用于向弹簧362施加不同的压力。
在另一个实施例中,不是导线上的全部作用力都反馈给用户。在一个实施例中,系统区分轴的阻力和远侧末端处的阻力,仅将远侧末端处的阻力反馈给用户。
为区分轴上阻力和末端处阻力,使末端向不同方向颤动。如果阻力在末端上,则阻力仅在一个方向上很大。如果阻力是由轴打圈引起的,则阻力在所有方向上均相等。通过在处理器中比较力以及分开移动远侧末端所需要的力,可防止在末端处形成较大的力。较大的电机扭距可仅用来克服由于打圈而导致的阻力,而非用于当末端遇到阻力时使末端弯曲。因此,这样可防止在末端上产生较大的力并减少了末端发生咬进所处位置的危险。
图5C和5D示出断接盒和手持控制器的另一个实施例。在该实施例中,手持控制器380具有远端382和近端384。控制器大体为“香蕉形”,从而其符合人机工程学地配合在用户手中。此外,控制器380的近端384朝向为当用户将控制器握在手中且他们手掌相对于地板水平定位时,近端向下指向地板。因此,从断接盒伸出的内窥镜轴近端成一定角度远离医生前臂且基本不可能产生妨碍。
手持控制器380还包括工作通道386的入口,其上有一个盖件。盖件的放置使工作通道的入口不面向医生,从而减小医生或护士受到体液或其它污染物喷溅的可能。通过取下盖件,用户可将工具插入工作通道进行取活检、施放药物或进行其它医学操作。
手持控制器388可有选择地耦合到断接盒380上。手持控制器包括控制内窥镜远侧末端方位的导向开关390。还可设置其它按钮或控制装置392以使用户启动内窥镜的其它功能或改变内窥镜成像系统的操作参数。
如图5D所示,手持控制器388通过协同工作的阴阳连接机构396、398有选择地耦合到断接盒380上。在所示出的实施例中,该连接机构包括弹性接纳在相应槽中的突片。然而可采用其它连接机构。
在其他实施例中,手持控制器可装配到抓紧轴远侧部的卡紧机构中。操作者因此可将手持控制器固定到沿轴长度的不同位置上以使医务人员可更靠近病人。
虽然所公开的内窥镜实施例通常需要操作者控制远侧末端的方位,本发明的一次性使用内窥镜还可自动操纵。由已编程处理器分析从成像电子件接收的图像以确定所需要的内窥镜远侧末端的方向或方位。在结肠镜检查的场合,此时内窥镜推进到盲肠,处理器控制吹气空气/气体的输送以向结肠吹气。而后处理器分析深色开放内腔的结肠图像,其通常标示内窥镜要推进的方向。处理器而后向伺服控制器提供控制指令,从而将远侧末端引向所定位的深色区域。
在其它模式中,控制柜中的处理器使内窥镜的远侧末端按预定图案移动。例如,当收回内窥镜时,可使远侧末端以螺旋搜索图案移动,从而扫描体腔的全部区域以查找疾病。通过采用远侧末端的自动控制,医生只需推进或回拉内窥镜来进行检查。
如将在下面更为详细描述的,一次性使用内窥镜通常包括具有一个或多个腔管的中空轴,这该腔管由终止于远侧末端的聚亚胺酯或聚乙烯管形成。此外,工作通道所采用的管子可用螺旋缠绕物加固。如图6A所示,远侧末端400的一个实施例包括具有远侧部402和近侧部404的圆筒。近侧部404具有比远侧部402直径更小的直径以形成台阶状肩部区域。肩部的直径选择为使内窥镜的轴壁可摞放在肩部区域上以与远侧部402形成平滑外部平面。远侧末端400的远侧面包括多个端口,其中包括照相内端口406、一个或多个照明端口408、工作通道腔管410的进入端口和导向冲洗端口412。
装配在照相机端口406中的是图像传感器(未示出),其优选包括CMOS成像传感器或其它固态成像设备和一个或多个玻璃或聚合透镜,该图像传感器生成表示照相机端口406前面场景图像的电子信号。图像传感器优选为低光敏性、低噪声、具有VGA分辨率或如SCGA、SXGA或XGA等更高分辨率的CMOS成像传感器。如果需要较低的分辨率,也可采用1/2VGA传感器。对于常规视频系统,需要25至30帧/秒的最小帧频来实现实时录像。系统的视频输出可以任何常规数字格式或模拟格式,包括PAL或NTSC或高清晰度视频格式。
照明端口408容纳一个或多个透镜和一个或多个发光二极管(LED)(未示出)。LED可以是高强度白光源或可以包括象红外线(IR)红、绿、蓝或紫外线LED的有色光源。采用有色LED,由于以任何一种或多种单独的颜色进行照明,因此可获得不同光谱带中的图像。通过有色LED同时或按序照明以及合并每个照明波长上的各有色图像,可获得白光图像。如果采用有色LED按序照明,作为可替换的方式,可采用单色CMOS成像器。作为LED的一种替换,光源可以在内窥镜外部且照明光通过光纤束传送到照明端口。
入口410是一次性使用内窥镜的工作通道或腔管的终止点。在一个实施例中,工作通道的近端终止于如图2所示断接盒26处。然而,工作通道可终止于内窥镜近端附近。
导向冲洗端口412包括引导液体或空气的盖件414,所述液体和空气穿过灌注和吹气腔管,越过远侧末端400前面,流向照相机端406和/或照明端口408。盖件414从而用于漂洗和干燥照相机端口406和照明端口408以使其中布置有内窥镜的内部体腔得到更好的观察。此外,冲洗液体还清洗内窥镜远端周围的组织区域。
图6B-6I示出形成根据本发明一次性内窥镜远侧末端的成像组件的另一个实施例。如上所述,成像组件必须是低成本、适于低廉组装且能完成与更昂贵成像机构可比拟的功能,从而医生能够采用该内窥镜检查病人。
如图6B所示,内窥镜的远端包括远侧盖件450,在远侧盖件450的前表面具有多个开口。这些开口包括工作通道452的开口和低压灌洗开口454,液体流由此则可传送穿过内窥镜以从病人体内去除碎片或障碍物。透镜冲洗和吹气端口包括整体式冲洗盖件456,其引导水流经图像传感器的透镜并传送吹入气体以使内窥镜所插入的体腔胀大。偏离内窥镜纵轴线的是透镜端口458,其由一对覆盖在照明源上的窗口或透镜460和462包围。
由图6C可更清楚地看出,成像组件包括远侧盖件450、圆筒形透镜组件470和热交换器480。热交换器480包括具有凹进部482的半圆形部分,圆筒形透镜组件470装配到该凹进部内。凹进部480使透镜组件470的位置保持在垂直于内窥镜纵轴线的方向上,从而只允许透镜组件470沿内窥镜的纵轴线移动。一旦透镜组件定位到其聚焦在固定于热交换器480后表面上的图像传感器上时,就用粘合剂将透镜组件固定到热交换器内。将一对LED 482、484结合到附加在热交换器中的电路板上,从而在电路板后面形成一个供液体或气体流过以冷却LED的通道。包含向控制单元发送信号和从控制单元接收信号的电路的电路板或线路板492固定在图像传感器490的后面并固定在热交换器480的后表面上。将透镜组件470、LEDS 480、482、图像传感器490和相关电路492固定到热交换器480内后,热交换器组件可装配到远侧盖件450内以形成完整的成像组件,如图6D所示。
图6E是远侧盖件450的等比例后视图。远侧盖件450优选由ABS塑料材料精确模制而成。如上所述,远侧盖件450的前表面包括整体式冲洗盖件456和一对位于LED前方的窗口460。优选地,窗口由透明塑料材料制成且与远侧盖件450的其余部分重合模制而成。在远侧盖件450的内部还有一个向近侧延伸的平面470,从而将远侧盖件的圆筒内表面分割成半圆形管以使半圆形热交换器480组件可装配在其内。突块472从远侧盖件450的内前表面伸出且与热交换器480的前表面对准以限制热交换器480可插入到远侧盖件450的程度。
图6F是放置在LED前方的窗口460、462的截面视图。窗口460优选由光学透明塑料材料制成,其具有将窗口460固定到远侧盖件450前表面中的外伸凸缘464。一旦窗口模制完成,就可将远侧盖件450模制在窗口460、462上以将其固定到适当位置上。
图6G是成像组件热交换器480部分的等比例前视图。如上所述,热交换器为半圆形部分,其具有与远侧盖件450内部的平面470相配合的较平底表面500和圆形上表面502。热交换器的内部为大体中空以形成通道,冷却液或气体可从该通道通过以冷却照明LED。在热交换器的底平面500内形成凹进部482以容纳圆筒形透镜组件470,如图6C所示。从热交换器480向后伸出的是一对腿部506、508,其上具有与热交换器480内部液体导通的孔。唇缘512在热交换器482的前面的内表面周围延伸以形成相应形状的电路板可装配和粘合固定到其上的结合表面。在本发明的一些实施例中,热交换器480还可包括额外的放置在腿部506、508之上的向后延伸的鳍部514、516,从而其之间形成槽以将电路板或其它部件固定到热交换器上。然而,在一些实施例中,可省略鳍部514、516。
图6H是热交换器480的等比例后透视图。如上所述,每个腿部506、508包括其中可装入管子的腔管520、522,且冷却液或气体可通过其中,从而该液体或气体在热交换器的中空半圆形通道部分内流动。此外,热交换器480可包括用于容纳热敏电阻或其它温度感应装置的凹部526,热敏电阻或其它温度感应装置可向控制单元中的处理器输送可指示发光二极管温度的信号。
图6I示出设计装配到热交换器480前面内的半圆形电路板550。特别地,电路板550粘合固定到热交换器480前面内贴住内部唇缘512,如图6G所示。电路板包括基底材料、电绝缘介电材料和电路层,基底材料可以是导热的金属或陶瓷。电路板550包括一个或多个迹线552和结合片554以用于向位于热导片556、558上的一对LED输送电流,热导片556、558位于凹进部482的两侧,当电路板安装到热交换器480内时,透镜组件470装配到凹进部482内。
在本发明的一个实施例中,基底材料是铜,热导片556、558也由铜制成。LED通过引线结合到结合片554和迹线554上。电路板550后表面优选涂覆导热、非活性的生物相容材料如金,其直接暴露于通过腿部506、508泵过热交换器的冷却液或气体。
在本发明的本优选实施例中,LED 484、486优选为涂覆有磷光材料的大面积冲模、高功率的蓝光LED,其一起产生约60流明的光。虽然本实施例示在透镜组件170两侧的两个LED,应当理解的是,可采用更多的LED,且对放置在LED前面的窗口形状做出相应的改变。
作为一种选择,窗口460、462的内表面可涂覆当暴露于由LED产生的蓝光下时发出白光的磷光层。具体的磷的选择可基于所使用的LED的光谱特性而定。磷可与施加到窗口460、462后表面上的环氧粘合剂混合且通过使远侧末端450经过紫外光源而固化。将磷涂层混合在粘合剂中促进磷的均匀分布且易于制造。
透镜组件470优选包括一组提供具有f-θ失真的140°视野的塑料镜片和一个f/8光栅。根据内窥镜的FDA手册文件,对于距远侧末端10mm的物体,透镜的分辨率应当为每毫米5线耦或更佳。透镜组件的各镜片和光栅容纳在可插入到热交换器480的圆筒形孔中的塑料圆筒内。透镜组件的前表面粘合密封到盖件450内的透镜端口458上。
在本发明的优选实施例中,图像传感器490包括具有640×480有效像素的VGA CMOS图像传感器和以串行形式向控制柜发送图像数据的在芯片上的串行器。这种CMOS图像传感器可从MicroElectronics of Boise,Idaho的Model No.MI-370型产品获得。为沿内窥镜长度发送串行图像数据和控制信号,数据和控制信号优选沿一对扭绞的微型同轴线缆分别发送。
为构建图像组件,包括有冲洗端口456的远侧盖件450由ABS塑料模制在LED窗口460、462上。其上结合有LED482、484的电路板550固定到热交换器480中,CMOS传感器490和相关的电子件492固定在两腿部506、508之间的热交换器480的后表面525上。透镜组件470插入到凹进部482内且在其粘牢在适当位置之前进行纵向调整直到其处于使光线聚焦在图像传器490上的最佳位置。所完成的热交换器组件而后可插入远侧末端450且粘结固定以完成成像组件。而后将其余的用于低压灌洗包块冲洗通道454、透镜冲洗和吹气通道以及工作通道的管子固定到远侧末端相应的腔管内以完成一次性使用内窥镜远侧成像部分。
图7示出与图6A所示类似的成像内窥镜的远侧末端600的实施例的更详细结构。在该实施例中,末端部分600包括多个设置在远侧末端600外周周围的相对钻孔602。相对钻孔602接纳朝向远侧末端的控制线缆(未示出)的型锻或带凸缘的端部。控制线缆上的拉紧力将远侧末端600拉向拉紧力的方向。
图8是根据本发明一个实施例的一次性使用内窥镜650的长度方向上的截面视图。远侧末端652粘结固定、焊接或以其他方式结合到铰接关节654远侧末端处的中央腔管内。固定到铰接关节654近端处的是轴656的远端。如上所述,轴656优选更为坚硬或具有更大扭转硬度或能够向内窥镜远端比向内窥镜近端更好地传递扭距。
移动内窥远侧端部所用的控制线缆658优选由非拉伸材料如不锈钢或高导向聚对苯二甲酸乙二酯(polyethylene-theralate)(PET)线绳制成。控制线缆658可在轴656的中央腔管内走线,或可如图8所示,穿过轴656壁内腔管走线。控制线缆560延伸穿过铰接关节654壁内的引导装置并终止于铰接关节654远端处或远侧末端部602内。在本发明的该优选实施例中,控制线缆为不锈钢Bowdin线缆,其具有带有如HDPE之类的光滑衬里的外部不锈钢护套和涂覆有用于减少摩擦力的如硅胶之类的润滑剂的内部线缆。外部护套容纳于铰接关节654的近端,而护套的近端固定到将一次性使用内窥镜配合到控制柜的连接器内。
如果控制线缆穿过轴656中央腔室走线,线缆优选由不锈钢或塑料螺旋缠绕护套携带以防止弯曲,且可采用如图9A和9B所示的过渡引导装置670引导控制线缆进入铰接关节的近端。过渡引导装置670具有固定在轴远端腔管内的近端672。过渡引导装置670的中央本体部分674具有与成像内窥镜外部直径相等的直径。此外,本体部分674包括多个从近端672的中央腔管向过渡引导装置的台阶状远端676的外表面延伸的对角线腔管678。远端676固定到铰接关节654的近端内。对角线延伸腔管678内的线缆从而被引导到导管的外部边缘,它们在该处延伸穿过铰接关节654的引导装置或控制线缆腔管。
图10A和10B示出用于形成一次性使用成像内窥镜的轴的一个实施例。轴680具有挤制套筒682,挤制套筒682可包括嵌入其中的金属丝或其它编织物684。如果具有编织物684,其可调整轴的扭距特性。套筒682可通过将一个套筒放置在一心轴上而形成。编织物684放置在套筒上,而心轴浸涂或喷溅涂层材料。套筒和涂层材料优选由聚亚胺酯制成或由其它既得生物医学用途的生物相容性材料如聚乙烯、聚丙烯或聚乙烯醇制成。在当前优选实施例中,套筒682由EG-80A硬度的聚亚胺酯制成,其外径为0.507英寸,内径为0.460英寸。不锈钢编织物嵌入其中且每英寸具有23个纬线。此外,轴的内部腔室和外部可涂覆可挤压的、亲水性光滑涂层,如可从Natick,Massachusetts的Boston Scientific Corporation公司获得的并在美国专利US5,702,754和US6,048,620中所描述的HYDROPASSTM材料,所述专利在此作为参考而被结合使用。
塑料螺旋缠绕物686如从Panduit Inc.公司获得的螺旋缠绕物,插入到轴680的中央腔管中。螺旋缠绕物686防止轴680在弯曲围绕在病人组织结构的弯曲处时被压坏。
在轴680的一个实施例中,螺旋缠绕物具有0.060英寸厚度和3/16英寸的螺距。螺旋缠绕物686具有0.500的外部直径和0.380的内部直径,并盘卷在轴680内以形成压配合。然而,应当理解的是,可采用具有不同螺距的其它厚度的螺旋缠绕物以提供所需的柱强度和弯曲模量并防止打结。在轴的铰接关节部上装配有塑料盖以防止污染物通过铰接关节的缝隙进入轴内。
如上所述,内窥镜轴的近侧部分优选比远侧部分更有柔性。轴的近侧部分优选由成波纹状的聚乙烯管制成,如由Panduit Inc.公司获得的No.CLTS 50F-C型号的聚乙烯管。
图11示出改变轴远侧部扭距保真度的一个方法。轴700具有朝向内窥镜断接盒远端的柔性部分702和更靠近断接盒(未示出)的较硬部分704。内窥镜更远侧部分向远侧末端具有渐增的柔性,且相反地在近侧具有较高的扭距保真度和柱强度。为增加轴远侧部分704的扭距保真度特性,在该部分内的编织物707包括两个或更多向相反方向缠绕的金属丝。在一个实施例中,金属丝编织物具有14-16个纬线的螺距。然而,金属丝的数目和它们的间隔可根据需要进行调整以适应轴的扭距保真度。
轴700的更远端702具有单螺旋金属丝706,其优选以与轴700中央腔管内的塑料缠绕物相同的方向进行缠绕。同样,轴702的近端扭距保真度可通过调整金属丝706的螺距和/或方向以及它的柔性而改变。
正如将会意识到的,单螺旋金属丝706提供一些扭距保真度,但不会具有与轴远侧部分中的双螺旋金属丝编织物相同的扭距保真度,从而使其更易于操纵以解决例如打圈问题。如果仅需要甚至更小的扭距保真度,则可在轴远侧部分省略单螺旋金属丝706。
如上所述,为便于操纵成像内窥镜远侧末端,内窥镜包括铰接关节,其可由控制线缆控制而允许远侧末端在其自身上反转即转过180°弧度,且可被引导向围绕远侧末端周围所需要的任何方向进行弯曲。也就是说,操作者可选择弯曲量或铰接量和弯曲方向。如图12A和12B所示,根据本发明一个实施例的铰接关节750由塑性可变形材料圆筒形成,该圆筒具有中央腔管752和多个位于铰接关节壁内的控制线缆腔管754。如果需要,圆筒壁内的控制线缆腔管之间的距离可较窄,从而控制线缆腔管形成延伸进圆筒中央腔管内的突起。如果采用3条控制线缆,则控制线缆腔管754优选以120°间隔定位,如果采用四条控制线缆,则控制线缆腔管754优选以90°间隔定位。
为便于弯曲铰接关节,圆筒包括多个沿其长度形成的活动铰链760。如图13可看出,每个活动铰链760包括一对在圆筒两侧相对的V形切口770,其由形成铰链可弯曲部分的柔性腹板772分隔开。在为四个控制线缆所设计的实施例中,每个活动铰链相对于相邻铰链成90°角定位。
当拉紧控制线缆时,那些具有与回缩控制线缆成一线布置的腹板772的活动铰链不会弯曲。那些具有不与控制线缆排成一线的腹板的活动铰链将会靠拢,从而使铰接关节在拉力的作用下在控制线缆的方向中弯曲。
图13所示铰接关节750的另一个优点是内窥镜的远端可通过同时拉紧全部控制线缆而缩回。这使医生能够在不必移动内窥镜其余长度的情况下操纵远侧末端。这在进行外科手术例如在获取活检或勒除息肉时是很有用的。
铰接关节可通过在适当位置挤制具有中央腔管和控制线缆腔管的圆筒并用刀、激光、喷水器或其它材料去除机构切割圆筒管以形成活动铰链而形成。可选择地,铰接关节可用适当位置的活动铰接接头模制而成。应理解,形成铰链的V形切口的角度可以是一定的或可以沿铰接关节的长度而变化。类似地,相邻活动铰链之间的间距可以是一定的或可以改变以适应铰接关节的弯曲和扭距保真度特性。在本发明的一个实施例中,每个活动铰链760具有30°的闭合角度,从而需要六个铰链以提供180°的运动。如上所述,铰接关节750的远端可被扩孔以容纳内窥镜远侧末端部分。类似地,铰接关节750的近端适于容纳内窥镜轴部远端。在图13所示实施例中,控制线缆腔管754与活动铰链的最宽间隔以及每个铰链的腹板部分对准。然而,可能需要使控制线缆腔管754相对于铰链偏移以减少铰链内控制线缆的潜在约束。如上所述,铰接关节应当由能弯曲但不会塌陷的适于医学使用的生物相容性材料制成。合适的材料包括聚亚胺酯、聚乙烯、聚丙烯或其它生物相容性聚合物。
当控制线缆由控制柜内的致动机构拉紧时,为防止铰接关节被控制线缆磨损,需要用具有不同硬度区域的材料制造铰接关节。如图14和15所示,由挤制管780形成的圆筒在其圆周上具有高硬度材料782和低硬度材料784的交替条带。用于控制线缆走线的腔管786形成于高硬度材料782中以当控制线缆拉紧或释放时抗磨损。此外,高硬度材料还降低控制线缆和周围腔管之间的摩擦。图15示出一种铰接关节,其中控制线缆腔管相对于活动铰链腹板部分的定位偏移,从而控制线缆不穿过铰链的腹板部分772。
图16A和16B示出铰接关节的可选择实施例。在该实施例中,该铰接关节包括一系列连接在一起的球窝连接器。如图16A所示,每个连接器包括窝部800和球部802。球部802装配到相邻连接器的窝部800内。腔管在球部802内轴向延伸以允许连接光源和图像传感器的电线和运送灌注液体和吹入气体的管子通过。球部和窝部优选由生物相容聚合物模制而成。
每个窝部可与用整球形成的球部形成连接,例如如图17A所示的球部810。可替换地,如图17B所示,可在窝部816上形成部分球部,如球部814。为给控制线缆提供移动空间,球部可包括在球部中间和侧面切开的槽818,如图17A、17B所示。可替换地,可在球部外周设置多个较小槽820,如图17C和17D所示。这些槽允许控制线缆在拉紧力的作用下变短。在球部和窝部的接合面处的多个孔822允许控制线缆从窝部穿进球部,如图17D所示。
在铰接关节的另一个实施例中,铰接关节由一连串堆叠的圆盘制成,这些圆盘彼此相邻接放置并可彼此相对移动。如图18A所示,圆盘850包括具有一对面向后方的摆动表面或凸轮854和一对面向前方的摆动表面或凸轮856的圆环852。凸轮854在圆环852的后表面上间隔180度设置,而面向前方的凸轮856在圆环852的前表面上间隔180度设置。在所示出的实施例中,朝前的凸轮856相对于后凸轮854成90°定位。圆环与每个凸轮相对的另一面是平坦地带部分,从而相邻圆盘的凸轮可与平坦部分接合并在其上摆动。在圆环和凸轮上钻有孔860以供控制线缆穿过。当拉紧控制线缆时,圆盘将会在凸轮854、856的表面上摆动,从而使铰接关节向所需的方向弯曲。
图18B示出由彼此接合以形成铰接关节的一连串堆叠的圆盘850a、850b、850c...组成的铰接关节。多条控制线缆870a、870b、870c、870d穿过圆盘并用于牵拉凸轮表面上的圆盘以使铰接关节向所需方向移动。
图19A和19B示出图18A和18B中所示铰接关节的可选择实施例。在该实施例中,铰接关节包括一连串堆叠的圆盘880,每个圆盘包括具有一对在其后表面上的凹穴882和一对在其前表面上的相应形状的凸轮884的圆环。凹穴882相对于凸轮884成90°角定位,从而相邻圆盘可堆叠在一起即一个圆盘的凸轮配合到相邻圆盘的凹穴内。对应形状的凸轮884和凹穴882有助于防止圆盘彼此相对转动。穿过圆环880形成孔或腔管886以供多条控制线缆890a、890b、890c、890d穿过,如图19B所示。孔或腔管886可设置在凸轮或凹穴的中央。然而,如果需要,用于控制线缆的孔可偏离凸轮和凹穴的位置。圆盘880优选由具有较光滑表面的生物相容性聚合物模制而成,如聚亚胺酯、聚丙烯或聚乙烯,从而减小相邻凸轮和凹穴之间的摩擦。
图20A和20B示出铰接关节的另一个可选择实施例。在该实施例中,铰接关节由一摞圆盘形成,每个圆盘包括一个圆环。圆环具有向前伸出的凸轮,凸轮内模制有弓形槽892,其当圆盘相对于相邻圆盘移动时允许控制线缆在凸轮内更自由地移动。从图20B可清楚地看出,槽892从凸轮外边缘处的最宽点894向窄点896渐缩,在该窄点处该槽形成延伸至圆环880相对边缘的圆孔898。当相邻圆盘转动时,控制线896在弓形槽892的变宽部分内自由弯曲。
虽然图18-20所示铰接关节的盘大体是圆形的,应当理解,可采用其它形状。图21A和21B示出由具有大体方形外部形状的多个部分形成的铰接关节。如图21A所示,部分900是一个具有一对销902的方形带,销902在方形部分后表面的相反侧延伸。在前表面的相对侧是一对相对的圆形凹部904,其与后表面上的销以成90°的角度定位,且其大小适于容纳相邻部分的圆形销902。在所示出的实施例中,控制线缆穿过位于方形部分900每个拐角处的角块906内的孔或腔管走线。图21B示出固定在一起的两个相邻方形部分900a、900b。如图所示,部分900b可绕其销相对于相邻部分900a向上或向下转动。虽然已示出圆形和方形铰接关节部分,应当认识到,还可采用其它片段形状如三角形或五边形等来形成铰接关节。
在上述铰接关节的实施例中,构成铰接关节的每个圆盘或片段优选由相同的材料制成。然而,可以改变制成这些片段的材料和/或物理尺寸或相邻片段之间的间隔以改变铰接关节沿其长度的挠性和扭距保真度。
在一些情况下,可能不需要成像内窥镜远侧末端的完全180°的转动半径。在这些情况下,由相互连接圆盘或片段制成的铰接关节可由柔性件如编织支架代替。图22示出采用编织支架930作为铰接关节的成像内窥镜925。编织支架930在远侧末端932和连接器934之间延伸,连接器934连接支架930的近端和柔性轴936的远端。盖件938延伸覆盖在柔性轴936和编织支架930上面。控制线缆(未示出)穿过柔性轴936延伸且用于牵拉支架930,从而将远侧末端932定位在所需的方向中。此外,同时牵拉全部控制线缆可使内窥镜的远侧末端缩回。
图23示出将控制线缆的远端固定到编织支架930上的一个方法。控制线缆940a、940b、940c、940d可编织过支架930的金属丝且通过在构成支架的金属丝周围结圈而终止。可替换地,线缆940的端部可焊接或粘合固定到支架的金属丝上。
图23A示出用于本发明一次性使用内窥镜的铰接关节的另一个可选择实施例1000。铰接关节1000由一连串堆叠环1002a、1002b、1002c、1002d等制成。每个环优选由深冲压钢材或其它金属形成,其使环坚硬但又具有薄壁形状以使内腔尺寸最大。绕环的外周等间隔设置的是向内延伸凹进部1004,其容纳用于将相邻环连接在一起的短弹簧部1006。在环1002相对边的两个弹簧用于将相邻环连接在一起。例如,如果三个环1002a、1002b、1002c对准,环1002a和1002b由位于环上0°和180°处的弹簧段连接在一起,而环1002B通过位于环周围90°和270°处的正交对准弹簧段连接到环1002C上。在相邻环之间形成缝隙,从而该对弹簧形成柔性关节,其可在远离铰接关节纵轴线的方向中弯曲,但具有将铰接关节向铰接关节纵轴线方向压缩的限制能力。每个弹簧1006利用粘合、打褶、焊接或采用其它固定机构固定到凹进部1004内。
图23A所示出的铰接关节1000具有的优点是,控制线缆穿过弹簧段1006的中央且处于铰接关节的外周上,从而使用于使管道或其它线缆通过每个环1002的中央开口的可用空间最大化,且使弯曲铰接关节所需的扭距最小化。
图23B示出图23A所示铰接关节的可选择实施例。在该实施例中,铰接关节包括多个深冲压或其它方式形成的金属环1008a、1008b、1008c,金属环由位于每个环内周上的弹簧连接在一起。每个环通过一对位于环相对边的弹簧段连接到相邻环上。弹簧1010通过粘合剂或通过焊接或采用其它固定装置固定到环1008的内周上。在图23B所示出的实施例中,控制线缆穿过弹簧段走线且离铰接关节纵轴线更近地设置。更靠近纵轴线可能需要在控制线缆上施加更大的力以使铰接关节向所需方向弯曲。
图23C示出铰接关节的另一个可选择实施例,其包括一连串堆叠的金属环1012a、1012b、1012c等。每个环1012连接有弹簧1015,弹簧1015具有交替的紧密缠绕部分1014和较松散缠绕部分1016,从而沿弹簧长度改变弹簧力。较松散缠绕部分1016允许铰接关节在该区域塌陷,而较紧密缠绕部分1014为相邻环1012提供铰链机构。每个环1012还包括一对模压的向内或向外延伸的突片1018,弹簧穿过这些突片,从而形成弹簧可通过打褶、焊接或其它方式固定于其上的表面。在图23C所示实施例中,每个环不是完整的圆筒形,但包括从与相邻环连接的连接点处向远处延伸的倾斜的前表面和后表面1020。环的倾斜面允许相邻环之间的渐增运动,而且还提供防止相邻环滑过彼此的止动部。相邻环上的倾斜表面1020从而形成铰接关节能够陷入其中的V形凹槽。
图23D示出类似于图23B所示铰接关节的另一种铰接关节的实施例。然而在该实施例中,铰接关节由多个环1022a、1022b、1022c组成,环1022a、1022b、1022c具有相对设置的凹槽1024和凸槽以允许具有交替紧密缠绕段和松散缠绕段的弹簧1015以交替方式经过一个环的外侧和相邻环的内侧。相对设置的凹槽和凸槽允许弹簧通过粘合、焊接或通过它结合机构固定到环上。
图23E和23F示出根据本发明的铰接关节的另一个实施例。在该实施例中,铰接关节由一连串堆叠的链节1022a、1022b、1022c等形成,这些链节与交替正交设置的成对弹簧段1024相连。弹簧段1024通过焊接、编织(braised)、粘合固定或以其它方式结合到每个环段的内周。环和弹簧段优选由不锈钢或其它生物相容性金属制成。弹簧可在用激光或其它切割工具切割之前固定到环上。可替换地,可将弹簧切成段,而后用组装夹具固定到环上。
如图23F所示,当从侧面观察时,每个环具有带有平坦部分1026和一对从平坦表面1026向后倾斜的倾斜部分1028的前表面。环的后表面具有类似形状但倾斜表面相对于前侧上的倾斜表面成90°的角定位。每个倾斜表面与铰接关节纵轴线的垂线成14°的角度,从而允许相邻环弯曲约28°。
图23G示出根据本发明的铰接关节的另一个可选择实施例。在该实施例中,铰接关节1030包括一连串金属链节1032a、1032b、1032c等,其由深冲压或模压的钢材或其它金属形成。每个链节具有大体环状结构1034,该结构可以是圆形或可以是多边形如八边形。此外,每个链节1032具有一对向后伸出的腿部1036,在腿部的端部具有向外伸出的突片1038。每个腿部1036设置在链节1032的相对侧上。在与腿部1036成90°的位置处,链节1032包括在链节侧壁内的相应孔1040以接纳相邻段的突片1038。此外,段1032包括一体形成的金属丝引导装置1042,该引导装置包括用于保持控制线缆的孔眼。通过将第一链节1032的突片1038插入相邻链节的相应孔1040中而将铰接关节中的相邻链节固定在一起。在一连串链节上可放置编织物以在无需增加弯曲该铰接关节所需要的力的情况下提高扭转强度。
图23H示出与图23E中所示链节类似的可选择链节实施例。然而在该实施例中,链节1050不具有圆孔1040,而代之以蝶形孔1052来容纳相邻链节的突片。蝶形孔1052用于限制相应扁平突片从相邻链带转动的程度。通过调整形成蝶形孔1052弧度的曲率,可控制相邻链节之间的转动程度。链节1050优选由深冲压金属和/模压操作形成。
图23I示出由一连串相互连接金属链节1060形成的本发明铰接关节的另一个实施例。每个链节1060具有一对向后延伸的相对腿部1062,腿部在每个端部具有向内延伸的突片。这些突片伸入到相邻链节的相应孔或槽内。然而,在该实施例中,每个腿部1062上的突片进一步延伸到该铰接关节的中央腔管内。每个突片还包括弹簧1066可从其中穿过的孔1064。由于弹簧1066防止突片1062从相邻链节中抽出,从而孔1064将突片锁定在相邻链节内。
图23J示出由一连串相互连接的链节1080a、1080b、1080c等形成的本发明铰接关节的另一个实施例。每个链节在其外周具有交替的箍圈或孔眼1082,该箍圈或孔眼1082是通过形成围绕链节一部分沿外周向延伸的槽,然后将链节的一部分向内弯曲而形成的。这些槽设置成在链节前表面的相对边上形成一对向内延伸的孔眼,且在该链节的后表面上形成与前表面上的孔眼成90°角定位的一对孔眼。利用在链节1080a、1080b、1080c等内这样形成的孔眼,可将弹簧固定到每个孔眼处的链节上。
图23K示出本发明的铰接关节的另一实施例,其类似于图23J所示铰接关节的设置。在该实施例中,铰接关节包括一连串金属链节1100a、1100b、1100c等。每个链节包括一对相对形成的、向内延伸的突片1104,其弯成可使弹性管或弹簧1106从中穿过的圆圈。通过将弹性管、弹簧1106打褶、焊接或以其它方式固定到突片1104上而将弹性管或弹簧1106固定到链节上。
图23L示出根据本发明的铰接关节的另一可替换实施例。在该实施例中,铰接关节包括一连串模压或深冲压的金属链节1120a、1120b、1120c等。每个链节包括一对在其前表面上向前延伸的突片1022和一对在其后表面上向后延伸的突片1024。在前后表面上的突片1022和1024彼此相对成90°角定位。每个突片1022、1024包括孔,固定机构可从孔中穿过以将排成一列的突片固定在一起。如图23M所示,通过一连串金属丝弹簧1040a、1040b等来提供固定机构。每根弹簧包括一金属丝,金属丝的一端插入铰接关节的一对对准突片的孔内。弹簧1040而后沿铰接关节的内腔延伸并具有第二端,该第二端穿过连接另一对链节的另一组对准突片的孔而终止。每根弹簧还可包括绕在其中的圈,其用作为在其中保持控制缆线的孔眼。
图23N-23P示出用于本发明一次性内窥镜的铰接关节的另一个实施例1200。在该实施例中,铰接关节包括一连串图23N所示类型的堆叠盘。每个盘1202上具有前面1206和后面1208。在盘的外围等间隔地分布多个孔1210,控制线缆可从孔中穿过。前面1206包括一对相对设置的平坦部分1207,其将盘分成两部分并限定一对可与相邻盘的相应平坦表面接合的一对表面。盘的前面还包括两个从平坦表面1207向近侧成一定角度的倾斜截面。在本发明的一个实施例中,该倾斜截面与垂直于盘纵轴线的线成大约14°角。类似地,后面1208包括两个从一对平坦表面向远侧成一定角度的倾斜截面,其中该对平坦表面相对于盘前面上的平坦表面1207旋转90°定位。如图23P所示,将多个盘1202a、1202b、1202c等叠置而构成铰接关节1200,从而在平坦表面处,每个盘与相邻盘对准,由此倾斜截面形成可在穿过铰接关节的控制线缆的拉紧下闭合的铰链。在图23P所示实施例中,有七对堆叠段1202,其中每对能够产生28°的弯曲。因此,图23P所示的铰接关节1200可向上、下、左、右总共弯曲196°。在铰接关节1200的近端是将铰接关节连接到轴远端的近侧连接器1220。在这一连串堆叠盘1202上套有外壳(来显示)以防止每个盘错位。
图23Q示出用于形成本发明铰接关节的另一种盘。每个盘1240类似于图23N和23M所示的盘1202。在该实施例中,每个片段具有前表面,前表面有一对从一对相对的平坦表面1246倾斜的倾斜表面1242、1244。类似地,在每个片段的后表面上,倾斜表面设置成与前表面上的倾斜表面正交。相邻盘1240a、1240b由一对相对设置的弹簧段固定在一起,弹簧段的端固定在盘前后表面的平坦表面部分内形成的凹部或钻孔中。弹簧段还用作控制线缆可从中穿过的引导装置。此外,弹簧防止相邻片段彼此相对转动或变得错位。
图23R示出可用于形成根据本发明的铰接关节的片段的另一个可选择实施例。在该实施例中,铰接关节包括一连串具有中央圆筒轴1302和外部圆筒轮缘1304的片段1300。轴1302通过多个向外伸出的辐板1306连接到外部圆筒1304上。每个辐板从轴附近的中心点朝外环1304的中线向下倾斜。倾斜的辐板1306使相邻片段能够在轴点处接触并在辐板不相互碰撞的情况下彼此相对转动。每个辐板还包括朝向外边缘的腔管1312,控制线缆可穿过该腔管。片段1300的外缘1304具有设置在圆周上的有间隔的齿1308、1310,从而每个片段的齿与相邻片段的凹部对准。
图23S示出一连串彼此相对弯曲以形成铰接关节的片段1300a、1300b、1300c等。每个单个片段1300优选由热塑性材料或金属模制而成。
图23T示出根据本发明的铰接关节的另一可选择实施例。在该实施例中,铰接关节由一连串片段1330a、1330b、1330c等形成。每个片段包括中央销1332和在其一端径向伸出的腿部1334。每个腿部1334的外缘具有供控制线缆穿过的孔。中央销的端部象脊柱一样抵靠片段,从而使每个片段1332能够摆动抵靠相邻片段。在一些实施例中,可能希望用网状管套在片段上以保持各片段的对准。
图23U示出连接到相邻链节以形成根据本发明的铰接关节的链节的另一个实施例。在该实施例中,该链节包括金属注模环,其具有一对相对设置的向后延伸环1352和一对相对于向后延伸环1352成90°角定位的向前延伸环1354。通过使一个链节的向前延伸环抵靠相邻链节的向后延伸环就可使相邻环对准。每个环1352或1354包括铆钉可从中穿过的孔以将环固定在一起。环1350的内周包括一对整体形成的控制线缆引导装置1356以限制控制线缆在链节内的移动。
图23V示出类似于图23T中所示的链节1350的可选择实施例1370。在该实施例中,每个链节包括一对其中有孔的向后延伸突片1372和一对在其内表面上具有整体形成销(未示出)的向前延伸突片1374。一旦连接,具有向内延伸销的突片1374装配到相邻链节的向后延伸突片1372的孔内。从而无需用单独的铆钉固定两相邻链节。链节1370还包括一对相对对准的控制线缆引导装置1376以限制控制线缆在链节1370中的移动。
图23W示出链节的另一个可选择实施例,其与其它链节组装以形成根据本发明的铰接关节。在该实施例中,链节1390包括注模环,其具有一对相对对置的在其后表面上的弓形凹槽1392和一对在其前表面上相应形状的向前延伸的弓形突片1394。前表面上的突片1394相对于后表面上的弓形凹槽1392呈正交设置。一体形成的控制线缆腔1396与每个弓形突片1394的内表面对准,该线缆腔限制控制线缆在链节1390内的移动。
由于链节1390由热塑料材料模制而成,弓形突片1394可压装到相邻链节的弓形凹槽1392内,从而允许相邻链节彼此相互前后摆动。
在一些实施例中,铰接关节设计成施加恢复力,从而当释放控制线缆的拉紧力时,一次性使用内窥镜将趋向伸直。在其它情况下,可能需要使远侧末端的位置保持在某一方向。在那种情况下,可采用图24所示的结构。此处,成像内窥镜的轴包括内部套筒1450,其由两个或更多塑料螺旋缠绕物1452、1454和1456覆盖。缠绕物1452按顺时针方向缠绕,而缠绕物1454按逆时针方向缠绕在缠绕物1452上,缠绕物1456按与第一缠绕物1452相同的方向缠绕。缠绕物由较粗糙的塑性材料形成,从而在交替缠绕的缠绕物层之间产生摩擦。用于塑性缠绕物的合适材料包括编织聚酯或聚亚胺酯带。当通过任何控制线缆拉紧内窥镜时,塑性螺旋缠绕物将会彼此相对移动且重叠的缠绕物之间的摩擦力将会趋于将内窥镜的定位保持在所需要的方向。内窥镜将保持在所需要的方向直到其被控制线缆拉向不同的方向。覆盖在交替缠绕的螺旋缠绕物1452、1454和1456上的是编织物1458。该编织物由交替方向缠绕的一个或多个塑性线或金属丝线形成。外套筒1460覆盖编织物1458而形成所述轴。
图25示出用于根据本发明的一次性使用内窥镜的轴结构的另一个可选择实施例。该轴包括护套1470,在护套1470的外周交替围绕有高硬度材料带1472和低工硬度材料带1474。高硬度材料和低硬度材料形成沿轴长度方向延伸的纵条。在护套1470内是塑性螺旋缠绕物1475,其防止轴1470在病人组织结构内弯曲时被压碎。高硬度材料增加轴的扭距保真度特性。高硬度材料条与低硬度材料的宽度比可根据所需要的扭距保真度进行调整。
在用成像内窥镜进行检查期间,医生可能需要扭转内窥镜以将其引向所需方向。由于内窥镜的外表面优选涂覆润滑剂而且是圆形,医生很难在轴上保持住合适的支点以转动它。因此,本发明的成像内窥镜可包括抓握机构以帮助医生握住轴来使其转动或纵向移动。轴的抓握装置的一个实施例如图26所示。此处,抓握器1500包括U形件,该U形件具有与成像内窥镜20的纵轴线相一致的一对腿部1502、1504。腿部1502、1504的远端处为两个90°的弯曲部1506、1508。抓握器1500包括位于连接腿部的抓握器弧形弯曲部分处的孔1505和在每个90°弯曲部1506、1508内的孔。成像内窥镜穿过这些孔,从而抓握器1500沿内窥镜轴部长度可滑动。用于适应抓握器的材料的弹性特性使腿部1502、1504从内窥镜的轴偏离开。只有弯曲部分1506、1508处的相对孔的摩擦力阻止抓握器1500沿轴的长度自由滑动。在腿部1502、1504的内表面上具有一对接触垫1510、1512,其具有形状与内窥镜轴部的外周相配合的内表面。当医生径向向内挤压腿部1502、1504时,接触垫1510、1512与轴接合,从而医生能够推拉或旋转内窥镜。当释放腿部1502、1504时,接触垫1510、1512从轴表面脱离,则如果需要,抓握器1500可以沿轴的长度移动至另一位置。
图27示出类似于图26的抓握器,其中相同部分由相同的参考标记表示。在该实施例中,抓握器包括两个位于腿部1502、1504外表面上的半球形圆盘1520、1522。半球形表面1520、1522设计成适于握在医生手中且增加抓握器到轴的径向距离,从而在需要时更易于扭转轴。
图28示出轴抓握器的另一个可选择实施例。在该实例中,抓握器1550包括具有一对腿部1552、1554的U形件,这对腿部与成像内窥镜的纵轴线垂直定位。腿部1552、1554包括形状适合于容纳内窥镜轴部外径的凹部1556、1558。在腿部远端设置指旋螺丝1560以将腿部拉在一起并使腿部1554、1556牢固地与内窥镜轴接合。当释放指旋螺丝1560时,腿部1554、1552可偏离轴,从而可移动抓握器1550。通过转动腿部1552、1554可相对于轴的纵轴线扭转轴。
图29示出图28所示抓握器1550的可替换实施例。在该实例中,抓握器1580包括具有一对腿部1582、1584的U形件。在每个腿部的远端具有形状适合于容纳轴外径的凹部1586、1588。轴放置在凹部1586、1588内,且在腿部1582、1584的端部和抓握器1580的U形弯曲部之间设置指旋螺丝1590。通过旋紧指旋螺丝,腿部压住成像内窥镜20的轴,从而允许医生通过移动抓握器1580而转动内窥镜。
在本发明的一个实施例中,内窥镜具有可移动套筒,该套筒可操作以在使用之前保持内窥镜远端清洁并当内窥镜使用完毕后遮盖与病人接触的内窥镜端部。
图30A和30B示出在远端具有海绵1504的内窥镜1594的一个实施例。海绵装在内窥镜上且具有可剥脱的包装材料,当去除包装材料后,可向海棉中加水或其它液体。水激活亲水涂层,从而使内窥镜远端增加润滑性。此外,当海绵压缩时可用作抓握器以使医生能够牵拉和/或扭转内窥镜。
在内窥镜的远端上设置可折叠套筒1598,其可收缩以露出探头的被润滑远侧末端。在一个实施例中,套筒1598的远端固定到海绵1594上,近端固定到断接盒上。向近侧移动海绵使套筒收缩,从而使内窥镜处于准备使用状态。在使用后,海绵1594向远侧移动使套筒在内窥镜远端上伸展。由于套筒的伸展,探头上的任何污染物就不太可能与进行该过程的病人、医生或工作人员接触。
在一些情况下,可能需要限制成像内窥镜远侧末端处散发的热量。如果采用发光二极管,它们在产生照明光过程中发热。类似地,图像传感器在工作期间产生一定热量。为限制内窥镜远侧末端变得过热和/或使这些部件具有较长寿命,则需要散热。解决此问题的一个技术是在成像内窥镜的远侧末端形成无源散热片。如图31所示,远侧末端1600包括盖件1602和由如生物相容性金属之类的散热材料制成的散热部1604。散热部1604包括具有较平坦底部1608的半圆形开口1606,平坦底部1608大致沿散热部1604的直径延伸。平坦底部1608形成如LED和图像传感器之类的电气元件可通过热导粘合剂或其它热导材料安装在其上的垫。产热设备将会将工作期间产生的热量传递至散热部分1604。远侧盖件1602盖在散热部1604的远端以防止散热部1604接触体内组织以及当成像导管在病人体内移动时保护人体。可能需要棱镜、透镜或其它折光装置使入射到内窥镜远端的光折射到任何固定到散热部1604的较平坦底部1608上的成像电子装置上。
图32示出内窥镜的散热远侧末端,其中远侧末端不包括盖件,但其由单件散热材料如生物相容性金属模制而成。散热部1620也包括具有沿该散热部直径延伸的较平坦表面1622的半圆形开口,且产热电气装置可安装在该平坦表面上。通过在散热远侧末端1620的远端内形成的半圆形开口,照明机构和图像传感器安装在平坦表面1622上。将灌注端口定位以将水引导到半球形切口上以清洗照明机构和图像传感器或图像传感器透镜。
在本发明的另一个实施例中,内窥镜远端处的成像装置可由穿过腔管流到内窥镜端部并排出体外的空气或水冷却。例如,受压的空气可通过成像电子装置附近的开口排出。空气膨胀降低了其温度,从而冷却成像电子装置。而后迫使热空气通过排气腔管排出到内窥镜的近端。可替换地,内窥镜可包括将水输送到远侧末端处的热交换器的送水腔管。被远侧末端内的电子元件加热的水通过回水腔管排出。
图33示出图31所示无源散热远侧末端的可替换实施例。在该实施例中,散热远侧末端1640具有多个位于远侧末端周围的缺口通道1642。缺口通道1642增加了散热远侧末端的表面积,进而增加末端散发来自照明和成像电子装置的热量的能力。
虽然本内窥镜成像系统具有许多用途,其尤其适于进行结肠镜检查。在一个实施例中,建立具有螺距为1/4英寸的0.060内部螺旋缠绕物并涂覆亲水涂层的直径为10-13mm的模型,从而具有0.15的摩擦系数,其可与传统内窥镜的0.85摩擦系数相比拟。此外,本发明内窥镜需要0.51bs.的力来将其推过2英寸的U形弯曲部,而传统内窥镜不能通过这么窄的弯曲部。因此,本发明能够制造低廉轻型的结肠镜,从而由于其较低的摩擦系数或更佳的跟踪能力而使病人更为舒适。
除进行结肠镜检查外,本发明的内窥镜成像系统还用于各种外科装置中,包括套管、导引线、括约肌切开器、结石取出气囊、收回筐(retrieval baskets)、扩张气囊、支架、细胞刷、结扎装置、电止血装置、硬化治疗针、勒除器和活检钳。
套管与内窥镜成像系统一起使用,从而将套管插入胆道口括约肌或乳突以到达胆管或胰管。导引线可被从内窥镜的工作通道向下送入并用作向感兴趣区输送手术器械的轨道。括约肌切开器用于打开乳突以放置支架或从病人体内取出结石。结石取出气囊用于与导引线一起将结石拉出胆管。收回筐也是用于从胆管内取出结石。扩张气囊用于扩张胃肠道、尿道或肺部管道中的狭窄处。支架用于张开胃肠道、尿道或肺部管道的狭窄处。支架可以是金属、塑料、自膨胀或机械膨胀的,且通常从导管的远端送入。细胞刷安装在导引线端部以用于采集细胞样本。结扎装置用于结扎食道内的血管曲张。带状结扎器采用弹性带约束血管曲张。电止血装置采用电流烧灼胃肠道内的出血组织。硬化治疗针用于向血管曲张内注射凝结剂或密封剂。勒除器用于从胃肠道去除息肉,而活检钳用于采集组织样本。
可采用本发明内窥镜成像系统进行治疗的特定外科手术实例包括通过膨胀剂植入、植入体、胃底折叠术、组织结疤、缝合或瓣阀置换或其它有助于下部食道括约肌(LES)闭合的技术进行的胃食管倒流疾病(GERD)的治疗。
外科手术的另一个实例是通过扩展植入体或进行缩减手术、肠道旁路以及褶皱或形成组织折叠以帮助病人减轻体重,从而治疗病理性肥胖。
内窥镜粘模切除术(EMR)涉及通过向固着息肉或扁平病变处(flat lesions)注入盐水或类似物以在切除之前使其变高以进行切除。本发明的内窥镜可用于送入在进行该手术过程中所使用的针、勒除器和活检钳。
此外,本发明的内窥镜成像系统可用于进行全层皮切除(FTRD),其中切除胃肠道的一部分且伤口用吻合器或钉扣愈合。最后,本发明的内窥镜成像系统可用于输送硬化剂以杀死组织或药物输送剂以治疗体内组织的疾病。
虽然已解释和描述了本发明的优选实施例,应当意识到,在不脱离本发明的范围的情况下可以对其进行各种改变。例如,虽然一些公开的实施例采用牵拉线缆来压缩内窥镜的长度,应当认识到还可采用其它机构,如专用线缆。可替换地,可采用弹簧向远侧偏压内窥镜,并采用线缆压缩弹簧从而缩短内窥镜的长度。此外,虽然所公开的实施例采用旋转伺服电机来驱动控制线缆,但还可采用其它致动器,如线性致动器。类似地,虽然在优选实施例中描述的内窥镜包括工作通道,应当理解可省略这类通道,而可采用导管向所需要的部位输送专用工具,如勒除器、射频消融尖端等。可替换地,导管可单独用于成像。最后,虽然所公开的部件描述为用于内窥镜成像系统,应当理解,许多部件可具有其自身独立的用途或在其它医学设备中使用。因此,本发明的范围由下面的权利要求书及其等同表述限定。
Claims (55)
1、一种成像内窥镜,包括:
轴,其具有近端和远端以及其中的一个或多个腔管;
一个或多个发光二极管,其位于轴远端处或附近以照明组织;
在轴远端处的成像组件,其包括成像传感器以生成组织图像;
多条控制线缆,其有选择地拉紧以使轴向在所需要的方向上弯曲;
可变形的铰接关节,其包括多个由弹簧段连接在一起的链节且在一个或多个控制线缆的拉紧下可弯曲;和
套在铰接关节上的护套。
2、根据权利要求1所述的成像内窥镜,其特征在于,控制线缆穿过将相邻链节连接在一起的弹簧段。
3、根据权利要求1所述的成像内窥镜,其特征在于,每个链节包括前表面和后表面,每个表面上均具有一对倾斜表面,从而这些相邻链节的倾斜表面能够增加链节的弯曲度。
4、根据权利要求1所述的成像内窥镜,其特征在于,将相邻链节连接在一起的弹簧段具有一致的螺距。
5、根据权利要求1所述的成像内窥镜,其特征在于,将相邻链节连接在一起的弹簧段具有交替的紧密缠绕部分和松散缠绕部分。
6、根据权利要求5所述的成像内窥镜,其特征在于,轴包括其中具有内窥镜的工作通道入口的断接盒,轴在断接盒远侧比在断接盒近侧具有更大的扭距保真度。
7、根据权利要求1所述的成像内窥镜,其特征在于,还包括在近端处用于将内窥镜连接到控制柜的连接器,该连接器包括:
控制线缆的端部缠绕于其上的一个或多个线轴;
将液体引导到内窥镜内的不同腔管的总管;和
用于将信号发送到图像传感器及从图像传感器接收信号的电连接器。
8、根据权利要求7所述的成像内窥镜,其特征在于,总管包括两片结合在一起以在其间形成通道而将液体引导到内窥镜内不同腔管的热塑性材料。
9、根据权利要求7所述的成像内窥镜,其特征在于,连接器包括两个线轴,每个线轴具有两条缠绕在其上的控制线缆。
10、根据权利要求7所述的成像内窥镜,其特征在于,连接器具有三个线轴,每个线轴具缠绕在其上的控制线缆。
11、根据权利要求7所述的成像内窥镜,其特征在于,连接器具有四个线轴,每个线轴具有缠绕在其上的控制线缆。
12、一种一次性使用内窥镜,其可拆卸地连接到重复使用的控制单元上以形成用于检查病人内部体腔的系统,该内窥镜包括:
轴,其具有近端和远端以及其中的多个腔管;
铰接关节,其位于所述远端处或附近以允许轴的远端可选择地被定向;
多条控制线缆,其将铰接关节拉向所需的方向;
成像组件,其位于轴的远端处或附近以生成内部体腔的图像,该成像组件包括:
盖件,其具有至少一个照明光可穿过的照明端口和一个成像端口;和
热交换器组件,其包括:一个或多个安装在其中的发光二极管,与发光二极管热接触的冷却通道,透镜组件和固态成像设备,其中,热交换器组件可插入所述盖件中。
13、根据权利要求12所述的一次性使用内窥镜,其特征在于,成像组件的盖件包括两个照明端口,每个端口具有模制到盖件前表面内的窗口。
14、根据权利要求12所述的一次性使用内窥镜,其特征在于,热交换器包括圆筒形凹部,圆筒形透镜组件装配到该圆筒形凹部中以将该透镜组件保持在热交换器内。
15、根据权利要求13所述的一次性使用内窥镜,其特征在于,照明端口的每个窗口涂覆有磷光剂。
16、根据权利要求15所述的一次性使用内窥镜,其特征在于,磷光剂通过粘合剂施加到照明端口窗口的内表面上。
17、根据权利要求15所述的一次性使用内窥镜,其特征在于,成像组件包括具有至少两根被屏蔽导线的线缆,以用于有区别地传送来自固态成像设备的信号。
18、一种成像内窥镜,包括:
控制柜,其包括多个致动器以操作控制内窥镜的定向;
图像处理板,其用于生成从内窥镜中的图像传感器产生的信号接收的图像;
显示器,其用于显示组织图像;
一个或多个阀,其用于控制向内窥镜内的一个或多个腔管输送灌注液体、吹气空气/气体和真空;
手持控制器,其包括多个可由医生启动以向控制柜提供命令的控制装置;以及
一次性使用内窥镜,其可拆卸地连接到控制柜上,该内窥镜包括:
轴,其具有近端和远端以及其中的一个或多个管子或腔管;
一个或多个用于提供照明光而照明生理组织的发光二极管;
在内窥镜远端处的图像传感器,其用于生成生理组织的图像;
铰接关节,其包括多个由弹簧段连接在一起的叠置段以允许相邻段彼此相对弯曲。
多条控制线缆,其具有固定到铰接关节的远端和近端,所述近端有选择地由致动器拉伸以定位内窥镜远侧末端;
19、根据权利要求18所述的成像内窥镜系统,其特征在于,控制线缆具有外护套,该外护套具有当控制线缆被拉紧时保持固定的端部。
20、根据权利要求18所述的成像内窥镜系统,其特征在于,内窥镜通过连接器可拆卸地连接到控制柜上,该连接器包括控制线缆连接在其上的多个线轴和用于可选择地将空气、水或真空引导到内窥镜的一个或多个管子或腔管中的总管。
21、根据权利要求18所述的成像内窥镜系统,其特征在于,手持控制器通过有线线路连接到控制柜。
22、根据权利要求18所述的成像内窥镜系统,其特征在于,手持控制器通过无线线路连接到移动控制柜。
23、根据权利要求18所述的成像内窥镜系统,其特征在于,手持控制器向用户提供触觉反馈,该触觉反馈与移动远侧末端所需要的力成比例。
24、根据权利要求23所述的成像内窥镜系统,其特征在于,控制柜包括将移动所述轴所需要的力与移动远侧末端所需要的力分离开的处理器,且其中向用户提供的触觉反馈与移动远侧末端所需要的力成比例。
25、根据权利要求18所述的成像内窥镜,其特征在于,控制柜包括确定内窥镜上的力并将其与可变制动阈值相比较的处理器,该处理器使致动器移动内窥镜的远侧末端从而使该力小于制动阈值。
26、根据权利要求18所述的成像内窥镜系统,其特征在于,控制线缆由金属制成。
27、根据权利要求18所述的成像内窥镜系统,其特征在于,控制线缆由PET制成。
28、根据权利要求18所述的内窥镜,其特征在于,轴涂覆有亲水涂层且轴还包括抓握器,该抓握器可被浸湿以激活亲水涂层。
29、一种用于操作可操纵内窥镜的手持控制器,包括:
手柄;
设置在手柄上以用于控制内窥镜功能的多个按钮;
用于输入使远侧末端在所需方向移动的命令的导向控制器;和
与该导向控制器耦合的反馈机构,其向用户提供移动内窥镜远侧末端所需力的触觉反馈。
30、根据权利要求29所述的手持控制器,其特征在于,导向控制器为操纵杆,反馈机构有选择地调整操纵杆上的弹簧的张紧力。
31、根据权利要求29所述的手持控制器,其特征在于,导向控制器为操纵杆,其可随至少两个电机运动且该反馈机构有选择地调整两个电机的扭距。
32、一种与内窥镜一起使用的成像系统,包括:
具有前表面的盖件,在该前表面中具有用于照明光和图像传感器的开口;
装配在盖件内的热交换器,该热交换器包括:
安装在其上的至少一个或多个发光二极管;
固定到热交换器上的图像传感器;
与一个或多个发光二极管热接触的通道;和
凹槽,透镜组件装配在该凹槽中并与图像传感器对准。
33、根据权利要求32所述的成像系统,其特征在于,盖件的前表面中具有与安装在热交换器上的发光二极管对准的窗口。
34、根据权利要求33所述的成像系统,其特征在于,所述窗口在其内表面上涂覆有磷光剂。
35、根据权利要求34所述的成像系统,其特征在于,该磷光剂涂层混有环氧树脂。
36、根据权利要求35所述的成像系统,其特征在于,环氧树脂由穿过盖件窗口射出的紫外光固化。
37、根据权利要求32所述的成像系统,其特征在于,盖件具有模制在盖件前表面内的冲洗端口,该端口将冲洗液体引导到透镜组件上。
38、一种一次性使用内窥镜,其可拆卸地连接到可重复使用的控制柜以形成用于检查病人内部体腔的系统,该内窥镜包括:
轴,其具有近端、远端和其中的一个或多个腔管;
铰接关节,其邻近轴远端以用于允许轴远端可选择地定位;
多条控制线缆,所述控制线缆被张紧以在所需方向中牵拉铰接关节;以及
连接器,其位于轴近端以将内窥镜可拆卸地连接到控制柜,该连接器包括引导灌注液体的总管,以使灌注液体可选择地输送到轴内一个或多个腔管。
39、根据权利要求38所述的一次性使用内窥镜,其特征在于,总管包括其中具有多个通道的柔性袋,灌注液体可流过所述通道。
40、根据权利要求39所述的一次性使用内窥镜,其特征在于,所述通道由一个或多个夹紧或释放柔性袋内通道的阀打开或关闭。
41、一种在病人内部体腔成像中使用的内窥镜,包括:
具有近端和远端以及其中的一个或多个腔管的轴;
布置在远端处或远端附近的装置,其使轴远端能够由多条控制线缆引导向所需的方向;
布置在内窥镜远端的成像装置,其用于照明体腔内组织且生成体腔图像;
用于有选择地使轴近端与可重复使用的控制柜相耦合的装置;和
用于有选择地将灌注液体和吹气气体导入内窥镜的一个或多个腔管的装置。
42、根据权利要求41所述的内窥镜,其特征在于,用于有选择将灌注液体和吹气气体导入内窥镜的一个或多个腔管的装置包括其中具有通道的一次性柔性袋,所述通道将灌注液体连接到内窥镜的一个或多个腔管,且其中所述通道由控制柜上的阀有选择地打开或关闭。
43、根据权利要求41所述的内窥镜,其特征在于,成像装置包括:
其中具有至少一个照明端口和成像端口的盖件;
热交换器,在其上安装有一个或多个发光二极管,该热交换器具有通道,冷却介质可穿过所述通道以冷却所述一个或多个发光二极管;
用于生成图像的成像传感器;和
使透镜组件与成像传感器对准的通道。
44、根据权利要求41所述的内窥镜,其特征在于,照明端口包括用于从一个或多个发光二极管产生的光产生白色照明光的装置。
45、根据权利要求44所述的内窥镜,其特征在于,白色光产生装置是照明端口上的磷光剂涂层。
46、根据权利要求45所述的内窥镜,其特征在于,磷光剂用可由紫外光固化的粘合剂粘结到照明端口上。
47、根据权利要求43所述的内窥镜,其中盖件包括引导灌洗液体冲过透镜的模制冲洗盖件。
48、根据权利要求41所述的内窥镜,其特征在于,使轴的远端在所需方向上被引导的装置包括由弹簧段连接在一起的多个叠置链节。
49、根据权利要求48所述的内窥镜,其特征在于,弹簧段具有一致的缠绕螺距。
50、根据权利要求48所述的内窥镜,其特征在于,弹簧段具有交替的紧密缠绕部分和松散缠绕部分。
51、根据权利要求41所述的内窥镜,其特征在于,用于有选择地使轴近端与控制柜耦合的装置包括控制线缆缠绕在其上的至少两个线轴,当轴耦合到控制柜时,所述线轴与控制柜中的电机接合。
52、根据权利要求41所述的内窥镜,其特征在于,还包括用于抓握轴以在病人体内移动轴的装置。
53、根据权利要求51所述的内窥镜,其特征在于,还包括:
用于确定移动轴远侧末端所需力的装置和用于向用户提供与移动轴远侧末端所需力成比例的反馈信号的装置。
54、根据权利要求51所述的内窥镜,其特征在于,控制单元有选择地在多个方向上移动远侧末端并估计移动轴的力和移动轴远侧末端的力,其中,移动远侧末端的力提供到反馈装置,该反馈装置向用户回送与移动远侧末端所需力成比例的触觉信号。
55、一种成像内窥镜系统,包括:
其中具有多个致动器的控制单元,所述致动器用于有选择地拉紧固定在其上的内窥镜控制线缆;
每个致动器具有用于测量由该致动器驱动的控制线缆上的力的传感器;和
处理器,其比较控制线缆上的力与可变制动阈值,并使多个致动器将内窥镜的远侧末端移动到一位置,以使控制线缆上的力小于可变制动阈值。
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EP2617350A1 (en) | 2013-07-24 |
EP2907446A1 (en) | 2015-08-19 |
JP4676427B2 (ja) | 2011-04-27 |
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US20080269561A1 (en) | 2008-10-30 |
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JP2006521882A (ja) | 2006-09-28 |
US20200359874A1 (en) | 2020-11-19 |
EP1610665B1 (en) | 2013-06-12 |
US20040199052A1 (en) | 2004-10-07 |
US7413543B2 (en) | 2008-08-19 |
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US9913573B2 (en) | 2018-03-13 |
AU2004226380A1 (en) | 2004-10-14 |
US20220233055A1 (en) | 2022-07-28 |
EP2617350B1 (en) | 2014-12-24 |
WO2004086957A2 (en) | 2004-10-14 |
US11324395B2 (en) | 2022-05-10 |
WO2004086957A3 (en) | 2005-03-24 |
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