CN101040769B - 用于肠道供给的插管装置 - Google Patents

用于肠道供给的插管装置 Download PDF

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CN101040769B
CN101040769B CN200710089418.4A CN200710089418A CN101040769B CN 101040769 B CN101040769 B CN 101040769B CN 200710089418 A CN200710089418 A CN 200710089418A CN 101040769 B CN101040769 B CN 101040769B
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intubaction device
pipe
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intubaction
endoscope
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CN101040769A (zh
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D·斯蒂芬奇克
J·T·斯皮维
O·瓦克哈里亚
J·J·库恩斯
R·D·阿普尔盖特
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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
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/00073—Insertion part of the endoscope body with externally grooved shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/0014—Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A61J15/0019—Gastrostomy feeding-tubes inserted by using a pull-wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0069—Tubes feeding directly to the intestines, e.g. to the jejunum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
    • A61B1/2736—Gastroscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A61J15/0007—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth inserted by using a guide-wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • A61J15/0023—Gastrostomy feeding-tubes inserted by using a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0053—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A61J15/0061—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin fixing at an intermediate position on the tube, i.e. tube protruding the fixing means

Abstract

提供一种与引导设备一起使用的插管装置，该引导设备具有适于与内窥镜连接的轨道，使得轨道的弯曲基本上与内窥镜的弯曲无关。该插管装置还包括细长挠性管和连接到管上的匹配部件，该匹配部件适于滑动地结合内窥镜外部的轨道。插管装置还包括组织支撑件，其设置在所述管的近端部分上，并且可在收缩结构和展开结构之间变化。管可定位在患者的上胃肠道中，使得管的近端可通过患者的胃壁和腹壁拉出，当组织支撑件处于展开结构时，其可以固定在内部胃壁上。

Description

用于肠道供给的插管装置
技术领域
本发明涉及下述专利申请，这些专利申请的所有内容通过引用并入本文：
美国序列号为10/440,957、公布号为US2004/0230095、于2003年5月12日提交的申请；
美国序列号为10/440,660、公布号为US2004/0230096、于2003年5月12日提交的申请；
美国序列号为10/440,956、公布号为US2004/0230097、于2003年5月16日提交的申请；以及
美国序列号为11/128,108、名称为“Medical Instrument Having aGuidewire and an Add-to Catheter”、于2005年5月12日提交的申请。
本发明总的涉及内窥镜医疗器械和方法，更具体地说，涉及可用在挠性内窥镜医疗手术中的装置和方法。
背景技术
医生使用穿过患者身体的自然开口插入的挠性内窥镜执行某些医疗手术。挠性内窥镜通常具有挠性手柄，该挠性手柄具有关节运动的远端，医生可以使用内窥镜近端上的致动器来控制该关节运动的远端。许多挠性内窥镜，包括胃窥镜和结肠镜，都具有必需的工作通道(也称为活检通道或附件通道)，使诊断和治疗器械访问有关的组织。工作通道的直径可以在1至4毫米的范围内，这取决于内窥镜的尺寸和类型。
工作通道的直径限制了医生能够穿过内窥镜使用的医疗器械，以及医生能够从患者身体上取出的目标(血凝块、活检样品等)的尺寸。此外，在使用仅具有一个工作通道的传统内窥镜时，还限制了医生一次只能使用一个器械，有时候在手术期间需要进行多次的、费时的器械插入/取出。可获得的某些专用内窥镜具有特大的工作通道或者一对工作通道。但是，这种专用内窥镜可能比较昂贵，直径较大，硬度较高，并且比标准内窥镜更难插管。
与上胃肠(GI)道相关的医疗手术的一个例子是将肠道供给管放置到患者的小肠内。该手术通常被称为经皮内窥镜胃空肠造口(PEGJ)术。在胃窥镜辅助式PEGJ中，在内窥镜可视的条件下，医生可以多次进行向上胃肠道中插入和从上胃肠道中取出胃窥镜，以便将供给管的远端放置到空肠内，以及将供给管的近端部分固定到腹壁和胃壁上。这些重复的插入/取出是费时的，并且还会在患者的上胃肠道中造成对组织的明显损伤以及术后痛苦。
同样的问题还存在于目前在下胃肠道中通过患者的肛门进行的插管手术。例如，有时候为了提高患者的舒适度，需要医生将结肠减压管放置到患者结肠内以释放体内产生的气体。但是，以目前技术使挠性管穿过结肠的曲折部分进入或许比较费时，对组织有损伤，以及使患者痛苦。
因此，需要一种改进的器械和方法，其适于和挠性内窥镜一起使用，并且改进了内窥镜访问与多种医疗目的的医疗器械相关的组织，医疗目的包括执行诊断和治疗手术，向胃肠道中供给流体营养物质，取出疾病组织以及释放气体。
发明内容
提供一种与引导设备一起使用的插管装置，该引导设备具有适于与内窥镜连接的轨道，使得轨道的弯曲基本上与内窥镜的弯曲无关。该插管装置还包括细长挠性管和连接到管上的匹配部件，该匹配部件适于滑动地结合内窥镜外部的轨道。插管装置还包括组织支撑件，其设置在所述管的近端部分上，并且可在收缩结构和展开结构之间变化。管可定位在患者的上胃肠道中，使得管的近端可通过患者的胃壁和腹壁拉出，当组织支撑件处于展开结构时，其可以固定在内部胃壁上。
还提供一种通过患者的体壁固定插管的方法，其中管的内部深入患者体腔，管的外部从体壁的切口向近侧延伸。该方法包括提供组织支撑件，该组织支撑件连接在所述管的内部上，所述组织支撑件可在收缩结构和展开结构之间变化。该方法还包括当所述组织支撑件处于所述收缩结构时定位所述管，使得所述组织支撑件支撑在体壁的内侧上，将管向近侧方向拉动，由将组织支撑件从收缩结构改变成展开结构，并将管的外部定位在患者皮肤上，由此将组织支撑件保持在展开结构中。
本发明具体涉及：
(1)一种插管装置，其用于与具有细长轨道的引导设备一起使用，所述插管装置包括：
基本上为挠性的管，其具有穿过其延伸的细长通道；
与所述管连接的导轨，所述导轨基本上与所述细长通道对准；以及
组织支撑件，其设置在所述管上，并且可在收缩结构和展开结构之间变化。
(2)根据第(1)项所述的插管装置，其中，所述组织支撑件在定位在患者的内部胃壁上时处于展开结构。
(3)根据第(1)项所述的插管装置，其中，所述导轨适于可滑动地接合所述引导设备的所述细长轨道。
(4)根据第(1)项所述的插管装置，还包括连接到所述管上的牵引细丝。
(5)根据第(1)项所述的插管装置，其中，所述管在其远端上包括闭合的逐渐变细的尖端。
(6)根据第(1)项所述的插管装置，还包括定位装置，所述定位装置具有可释放地连接到所述管上的第一连接部件，所述定位装置包括适于可滑动地接合所述引导设备的所述细长轨道的定位导轨。
(7)根据第(6)项所述的插管装置，其中，所述定位装置适于在位于患者体内时与所述管分离。
(8)根据第(1)项所述的插管装置，其中，所述组织支撑件包括第一端部、第二端部和多个臂，所述多个臂围绕所述管沿圆周间隔开并且连接所述第一端部和第二端部，所述第一端部连接到所述管上，所述第二端部可滑动地保持在所述管上并且位于所述第一端部的近侧。
(9)根据第(8)项所述的插管装置，其中，当所述组织支撑件处于所述收缩结构时所述多个臂相对于所述管基本上是平的，当所述组织支撑件处于所述展开结构时所述多个臂基本上弯曲并从所述管径向延伸。
(10)根据第(1)项所述的插管装置，其中，所述组织支撑件由聚合物管形成。
(11)根据第(1)项所述的插管装置，还包括定位在所述管上的延伸护套，所述护套具有第一端部和第二端部，所述第一端部可操作地连接到所述组织支撑件上，所述第二端部可通过患者的胃壁和腹壁向外拉出，医生可以相对于所述管移动所述第二端部，由此使所述组织支撑件从所述收缩结构运动到所述展开结构。
(12)根据第(1)项所述的插管装置，还包括设置在所述管上的锁定元件，所述锁定元件可操作地与所述组织支撑件连接，所述锁定元件适于将所述组织支撑件锁定在所述展开结构中。
(13)根据第(12)项所述的插管装置，其中，所述锁定元件是可释放的。
(14)一种插管系统，包括：
引导设备，其上具有细长轨道；
基本上为挠性的管，其具有穿过其延伸的细长通道，导轨连接到所述管上，所述导轨基本上与所述细长通道对准，并适于可滑动地接合所述细长轨道；以及
组织支撑件，其设置在所述管上，并且可在收缩结构和展开结构之间变化。
(15)一种用于将插管固定在患者的体壁中的方法，包括如下步骤：
提供组织支撑件，所述组织支撑件连接在所述管上，所述组织支撑件可在收缩结构和展开结构之间变化；
当所述组织支撑件处于所述收缩结构时通过所述体壁定位所述管，使得所述管相对于所述体壁包括内部和外部；以及
使所述组织支撑件从所述收缩结构运动到所述展开结构。
(16)根据第(15)项所述的方法，还包括步骤：将所述管的所述外部固定在患者上，由此将所述组织支撑件包括在所述展开结构中。
通过下面的说明书、附图以及所附的权利要求书，插管系统和方法的其他方面、变例以及实施方式将变得显而易见。
附图说明
图1是与内窥镜一起使用的引导装置的等轴测图；
图2是图1中装配到内窥镜上的引导装置的远端部分以及与引导装置滑动接合的附件的等轴测图；
图3是沿图2中的线3-3截取的横截面图，其中附件与支架滑动接合，并且支架与引导装置的轨道滑动接合，并且为了清楚已经除去了内窥镜；
图4是与图1中显示的引导装置一起使用的插管装置的等轴测图，其中插管装置包括显示为收缩结构的第一形式的组织支撑件(tissue bolster)；
图5是显示为展开结构的图4中组织支撑件的等轴测图；
图6是图4中显示的位于体壁中的插管装置的近端部分的侧视图，显示了处于收缩结构的组织支撑件；
图7是图6中显示的插管组织的近端部分的侧视图，显示了支撑在体壁上且变为展开结构的组织支撑件；
图8是位于体壁中的插管装置的近端部分的侧视图，其中插管装置包括显示为收缩结构的第二形式的组织支撑件；
图9A是图8中所示插管装置的近端部分的侧视图，显示了支撑于体壁上且变为展开结构的组织支撑件；
图9B是图9A中所示插管装置的近端部分的详细侧视图，显示了接合到定位孔中以将组织支撑件保持在收缩结构的可释放锁定元件；
图10是与图1中引导装置一起使用的定位装置的等轴测图；
图11是定位装置沿图10中沿线11-11获取的横截面图；
图12是可释放地连接到图4中所示插管装置的近端的图10中定位装置的近端的局部侧视图，其中定位装置和插管装置滑动接合在支架上，支架则滑动接合在引导装置的轨道上；
图13是可释放地连接到插管装置的远端的定位装置的近端的纵向截面图；
图14是可释放地连接到插管装置的定位装置的局部等轴测图，显示了插管装置前进到位于内窥镜远端的位置，并且定位装置滑动接合在引导装置的轨道上；
图15至20显示了与图1中引导装置装配在一起的并插入到患者上胃肠道内的内窥镜，其中图15显示了穿过胃壁和腹壁的透射部分的针头和套管；
图16显示了穿过线环的内窥镜的远端，所述线环通过穿过胃壁和腹壁放置的套管进入胃中；
图17显示了通过图10中定位装置沿引导装置前进的图4中插管装置，使得插管装置的远端位于内窥镜可视化范围内的空肠内；
图18显示了圈套连接到插管装置近端的牵引细丝的线环，在内窥镜的可视化范围内，插管装置近端已经通过定位装置推动而离开引导装置，并且进入到胃中；
图19显示了穿过胃壁和腹壁到达外部的插管装置近端和牵引细丝；
图20显示了支撑于胃壁内侧、变为展开结构且通过连接到插管装置外部的医疗夹具进行固定的组织支撑件，并且显示了连接到从患者体内取出的插管装置和内窥镜近端的Y-附件(Y-fitting)；
图21至23显示了带有穿过患者腹壁和胃壁定位的套管的圈套装置的使用步骤，其中图21显示了圈套装置的挠性部件的远端伸入胃中，同时挠性部件为直线结构；
图22显示了在挠性部件被保持时，将张力作用于张紧元件上，并且圈套装置的挠性部件的远端形成为环形结构且环绕插管装置的牵引细丝；
图23显示了张力从张紧元件上被释放，并且挠性部件为直线结构，同时丝线被圈套在挠性部件和张紧元件之间；
图24是插管装置另一实施例的远端部分的等轴测图，其滑动接合在图2中的引导装置上；
图25显示了装配到内窥镜上且穿过肛门插入到患者结肠内的图2中的引导装置；
图26显示了沿引导装置进入到患者结肠内的图24中的插管装置；以及
图27显示了位于患者结肠内的图24中的插管装置，并且从患者体内取出了内窥镜。
具体实施方式
如图1所示，总体以10表示的引导设备(也称为医疗设备)可以包括手柄12、从手柄12延伸的挠性护套14、连接到护套14的挠性轨道16以及连接到护套14远端的端帽18。手柄12和护套14的尺寸可以收纳挠性内窥镜。护套14可以由聚合物薄膜形成，如聚乙烯或聚丙烯薄膜，并且长度足以覆盖内窥镜的整个内镜部分。轨道16可以由一个连续的挠性低摩擦聚合物形成，如挤压成型聚丙烯。
各种类型的引导设备10在2005年5月12日提交的序列号为11/128,108的美国专利申请中进行了详细描述，该申请通用引用并入本文。
多种类型的内窥镜可以与引导装置10一起使用，包括具有关节运动的远端部分的传统的挠性胃窥镜、结肠镜或小儿结肠镜。虽然这些内窥镜通常包括工作通道，但是不具有工作通道的内窥镜也可以与装置10一起使用。一方面，装置10可以是与内窥镜可拆卸的以及一次性的，并且允许至少使用一个挠性附件装置。例如由于太大而不能穿过内窥镜工作通道的挠性附件装置。
附件装置可以适于在内窥镜外部的装置轨道上滑动，从而使得轨道的弯曲基本上与内窥镜的弯曲无关联。另外，可以相对于内窥镜来支撑轨道，从而使得轨道能够相对于内窥镜作圆周运动。
图2是装配到内窥镜20上的装置10的远端部分的等轴测图。装置10可以包括适于和轨道16滑动接合的支架22。支架22可以由挤压成型的低摩擦聚合物如PTFE整体形成，并且可以具有至少与轨道16一样长的长度。附件23可以适于和支架22滑动接合，如图所示。附件23可以适于向体内供应流体营养物，提供对诊断和治疗医疗器械相关的组织的访问，用于排出或释放体内的气体或其他流体，或者用于任意的多种其他医疗目的。
图3是沿图2中的线3-3截取的横截面图，其中附件23与装置10滑动接合。为了清楚起见，内窥镜20的横截面图没有在图3中显示。应当注意到，由于护套14可以由聚合物薄膜形成，所以内部没有内窥镜20的护套14可以不必保持图3中所示的圆形结构。
轨道16的横截面轮廓可以具有C形，用于限定T形的轨道通道26。支架22可以包括可以与轨道通道26滑动接合的T形导轨28。支架22还可以包括如图3所示的T形支架通道30，用于和附件23的T形附件导轨32(也称为匹配部件)滑动接合。
图4是插管装置24的等轴测图，该插管装置24可以与图1中引导装置10一起使用。插管装置24可以作为根据经皮内窥镜胃空肠造口(PEGJ)手术而置于患者体内的肠道供给管使用，将在这里描述。插管装置24的远端可以位于空肠内。插管装置24可以在近侧穿过小肠的空肠和十二指肠的近端部分延伸而进入到胃，并且穿过胃壁和腹壁，从而近端可以被注入营养物或其他物质。
插管装置24可以包括细长管34，该细长管34限定有贯穿的与远端开口36流体连通的通道38(见图3)。远端开口36可以距离插管装置24的远端大约5至15厘米，但是该距离可以改变。除了增加的导轨32之外，插管装置24的远端部分可以是特别类似于多种可商购的供给管的远端部分，例如可以从Viasys Healthcare，Inc.获得的140厘米长、10法郎、Dobb-Hoff型供给管。
导轨32和管34可以是单独形成然后接合在一起，或者由挤压成型聚合物如医用等级的聚氨酯整体形成。管34的长度可以大约在50至100厘米的范围内。导轨32可以沿管34的基本上整个长度或者沿管34的一部分或者多个部分延伸。导轨32可以适于与支架22可释放地接合，如图3所示。任选地，导轨32还可以适于和轨道16可释放地接合。
医疗润滑剂如K-Y JellyTM(Johnson and Johnson Corp.)可以施加到轨道32及其匹配组件、支架22或导轨16的界面上，以减小使插管装置24沿引导装置10移动所需的力。
一方面，插管装置24的近端和远端可以闭合。另一方面，插管装置24的远端可以逐渐变细以方便进入上肠胃道。
如图4所示，插管装置24的近端可以包括连接部件40，该连接部件40具有圆锥形形状，但其他形状也是可以的。连接部件40可以适于和定位装置接合在一起，其显示于图10中。
丝线42可以连接到插管装置24的远端。丝线42可以由传统外科缝合材料、细金属丝、聚合物线或天然纤维形成。一方面，丝线42的长度可以是大约20-80厘米。
如图4-9所示，插管装置24可以包括组织支撑件44，该组织支撑件44当进入到上胃肠道中时具有最小尺寸，当插管装置24的近端连接到腹壁时则自动展开。提供可伸缩的组织支撑件44使得在内窥镜位于上胃肠道中时插管装置24能够插入，从而最小化对上胃肠道的内层造成的损伤，同时提供对胃内部的可视化，并且避免在传统PEGJ手术中所需的内窥镜重复插入/取出。
在图4中，所示的第一形式的组织支撑件44位于插管装置24的近端部分，并且处于收缩结构。支撑件44可以例如位于距离插管装置24的近端大约10至15厘米处。当医生穿过腹壁拉动插管装置24的近端时，如图6和图7所示，支撑件44支撑在内部胃壁上，并自动展开到展开结构，如图5所示。
组织支撑件44可以由生物相容性聚合物形成，如一小段挤压成型聚氨酯管，其松散地配合在插管装置24的管34上。在支撑件44的位置，导轨32的一部分可以从管34上除去。支撑件44的第一端48可以例如利用粘结剂连接到管34上，第二端50可以允许在管34上自由滑动。
支撑件44可以包括位于第一端48和第二端50之间的多个臂46，这些臂46可以用支撑件44的材料由多个平行狭缝47形成。当第一端48和第二端50如图5所示相互靠近时，臂46径向向外挠曲，从而当展开时形成可以支撑于胃壁上的宽阔表面。当连接时，组织支撑件44还可以用于密封胃壁中的切口，以防止胃液泄漏到腹腔中。
图6显示了当插管装置24的近端部分穿过胃壁和腹壁中的切口时处于收缩结构的第一形式的组织支撑件44。图7显示了处于展开结构且支撑在内部胃壁上的图6中的组织支撑件44。当患者不再需要管34进行肠道供给时，医生可以拉动管34的外部以便将插管装置24从体壁切口中拉出，这如同使用具有非收缩式组织支撑件的传统肠道供给管的当前实践那样。
图8显示了处于收缩结构的第二形式的组织支撑件44，该组织支撑件44包括连接到支撑件44的第二端50上的支撑延伸件52。延伸件52可以是适于在管34上自由滑动的薄壁聚合物管。图9A显示了处于展开结构且支撑在内部胃壁上的第二形式的支撑件44。当拉动丝线42时支撑件44自动展开到展开结构，并且支撑件44支撑到内部胃壁上，并随之支撑到内部腹壁上。延伸件52为在展开结构和收缩结构之间操控支撑件44提供了外部控制，从而方便了定位和/或易于从患者体内取出插管装置24。延伸件52还可以是连接到末端50的一小段丝线，或者是可以沿着管34穿过腹壁切口的多种其他细长结构中的任意一种。
任选地，管34的外径可以是大约1.0至3.0毫米，小于延伸件52的内径，以便管34和延伸件52之间的间隙能够限定一个通道53，如图9B中的管34和延伸件52的详细视图所示。例如，医生可以将流体(如药液)注入到胃中，或者将延伸件52的近端放置为与吸入装置流体连通，以便从胃中取出胃液。
图9B还显示了可释放的锁定元件43，该锁定元件43与第一定位孔47和第二定位孔45可释放地接合。医生可以握住管34，同时在第一和第二定位孔47、45之间纵向移动延伸件52，以便分别将组织支撑件44可释放地锁定在展开结构和收缩结构中。可释放的锁定元件43的位置不限于管34的从患者体内伸出的近端部分，还可以设置在管34的靠近体内组织支撑件44的部分。还可以在图6所示的第一形式的组织支撑件44上设置类似的锁定元件，包括锁销、锁键等等，以便当组织支撑件44被拉到体壁上时将组织支撑件44锁定在展开结构中。组织支撑件44可以保持在展开结构而不需要将管34固定到体壁，如针对第一形式的组织支撑件44所描述的。
如前文所述，插管装置24可以在近端包括连接部件40，以接合另一附件。图10是这种附件，即定位装置54的等轴测图，该定位装置54与图1中所示的引导装置10一起使用。医生可以使用定位装置54来沿着引导装置10的轨道16或者沿着连接到轨道16的支架22在纵向方向远程移动插管装置24。当插管装置24的近端位于患者体内并且不是由医生直接操作时，定位装置54基本上使得医生能够朝远端方向推动插管装置24以及朝近端方向拉动插管装置24。定位装置54的另一个重要功能是使插管装置24相对于患者保持静止，以便内窥镜和引导装置10可以朝近端方向退出，并且可以从患者体内取出，而不会改变插管装置远端的位置。
定位装置54包括细长主体56，该细长主体56具有基本上沿主体56的整个长度连接到细长主体56上的导轨58(也称为匹配部件)。导轨58可以适于和支架通道30或者和轨道通道26(见图3)滑动接合。主体56和导轨58可以由一件连续的低摩擦聚合物材料如挤压成型聚乙烯或PTFE一体形成。
定位装置54的长度可以是至少与装置10的轨道16一样长，例如，大约在100至200厘米的范围内。定位装置54可以是足够挠性的，以便能沿着上胃肠道中的装置10进入和取出，但是与插管装置24相比要相对硬一些。定位装置54的主体56的横截面轮廓可以具有多种几何形状中的任意一种，包括图11中所示的圆形。主体56还可以包括至少部分贯通延伸的通道(未图示)，该通道可以用于，例如，注入或取出流体，为另一装置提供对上胃肠道的访问，或者用于其他目的。
定位装置54可以包括位于远端上的连接部件60(也称为第一连接部件)，用于可释放地连接到插管装置24近端上的连接部件40(也称为第二连接部件)。如图12所示，定位装置54的远端可以可释放地连接到插管装置24的近端，同时二者都可滑动地接合在支架22上，支架22则可滑动地接合到装置10的轨道16。
图13是接合在一起的定位装置54和插管装置24的纵向截面。从图12和图13中可以看出，定位装置54的连接部件60可以包括圆锥形插孔68，用于收纳插管装置24的连接部件40上的圆锥形凸起41。锁销64可以形成于连接部件60中，以便与连接部件40中形成的冲击凹槽66相接合，从而使得插管装置24和定位装置54的各自末端抵抗被拉开，直到作用有预定的分离力。这允许医生在纵向方向通过推拉定位装置54来定位插管装置24。
医生可以使用伸入到腹壁内经皮切口中的圈套装置或其他类型的夹持器械来固定插管装置24，同时拉动从患者口中延伸的定位装置54的近端以释放锁销64和冲击凹槽66，并分离装置24和54。本领域技术人员将会认识到，这里描述的连接部件40和60的实施方式仅仅是用于可释放地接合插管装置24和定位装置54的多种等价实施方式中的一个例子，连接部件40和60还可以包括远程操作的释放机构来分离装置24和54。
如图11和图13所示，定位装置54还可以包括位于主体56远端的狭缝62，以便当连接部件40和60接合在一起时为从插孔68中引出丝线42提供间隙。
图14是装配到内窥镜20上的引导装置10远端部分的等轴测图，显示了定位装置54的连接部件60可释放地连接到插管装置24的连接部件40。插管装置24、定位装置54以及引导装置10可以共同称为插管系统70。如图14所示，插管装置24可以朝远端方向前进到内窥镜20的远端，并且保持与定位装置54对齐和接合。因此，可以利用插管系统70而不是前述系统将插管装置24进一步定位到小肠内。另外，通过将插管装置24朝远端方向移动到内窥镜20远端的能力，丝线42位于圈套和外部化的有利位置。
用于将肠道供给管置于患者体内的医疗手术在现有技术中已知为PEGJ(经皮内窥镜胃空肠造口)术。该手术有时候也称为JET-PEG(空肠道管-经皮内窥镜胃空肠造口)术。图15-20显示了将插管装置24置于小肠内的方法。
首先参照图15，置于包括手柄12、护套16和端帽18的引导装置10内的内窥镜20可以穿过患者的嘴进入，将内窥镜20的远端和端帽18置于患者的胃中。可以在胃中使用光源(例如与内窥镜的远端相连的光源)以透射腹壁，以便可以从患者外部观察内窥镜在胃中的位置。可以穿过腹壁做出小的经皮切口，针头72(如14gauge针头)和套管74可以穿过该切口插入，使针头72的尖端和套管74的远端可以位于胃中。
参照图16，可以取出针头72，留置套管74，以提供在胃的内部与患者外部之间延伸的访问通道。环形引导线76(也称为线环)可以穿过套管74，并且内窥镜20和引导装置10可以被引导以穿过由引导线76提供的环延伸。内窥镜20和引导装置10可以从胃朝远端方向前进到小肠内，如图17所示。
如图17所示，定位装置54可以可释放地接合到插管装置24，并且可以用于使插管装置24沿着引导装置10的长度前进，从而使得插管装置24穿过由引导线76提供的环。
插管装置24的开口36可以在空肠内前进，同时在内窥镜20可视化的情况下，进入到理想位置以将营养物送入到胃肠道中。在一种实施方式中，插管装置24可以定位在患者体外的支架22(图2)上，并且插管装置24和支架22可以沿着引导装置10的轨道16一起前进。在另一种实施方式中，可以在将内窥镜20和引导装置10插入到胃肠道内之前，将支架22接合到轨道16上，然后插管装置24和定位装置54可以在支架22上前进。在另一种实施方式中，可以在将内窥镜20和引导装置10插入到胃肠道内之间，将插管装置24和定位装置54接合到引导装置的轨道16上。在另一种实施方式中，可以在将内窥镜20和引导装置10插入到胃肠道内之后，将插管装置24和定位装置54接合到轨道16上。
定位装置54可以保持在适当的位置，内窥镜20和引导装置10可以朝近端方向从胃中取出，从而使得插管装置24可以通过定位装置54被拉动而离开引导装置10的末端(如图14所示)。医生可以闭合线环76，将线环76紧紧固定到插管装置24(未图示)的近端周围，并向后轻轻拉动定位装置54以分离第一和第二连接部件40、60。然后，在内窥镜20可视化的同时，医生可以轻轻释放并控制线环76，以环绕从插管装置24的近端延伸的丝线43。丝线42的长度可以使用环形引导线32来圈套，如图18所示。
参照图19，可以穿过切口拉动丝线42和插管装置24的近端，直到组织支撑件44位于内部胃壁上，此时插管装置24的远端部分(包括用于提供营养物的开口36)位于小肠(如空肠)内。直到目前所述的手术期间，组织支撑件44一直处于收缩结构，以方便插管装置24在胃肠道内插入和放置。当医生将丝线42和插管装置24的近端拉到外部时，将支撑件44拉到内部胃壁上，支撑件44自动改变到展开结构。
图20显示了传统的外科夹具80，该外科夹具80靠着切口处的皮肤夹持到插管装置24的外部，从而将组织支撑件44牢固地保持在内部胃壁上，并随之支撑在腹壁的内侧。作为选择，外部密封件(未图示)可以在插管装置24的近端部分上进入以配合切口附近的患者皮肤。插管装置24的近端可以被切割，并且附件(fitting)78可以连接到插管装置24上位于患者体外的一端。内窥镜20、引导装置10和定位装置54可以从患者体内取出，将插管装置24的远端部分和开口36留在小肠内的理想位置。
在前面的描述中，通过穿过胃壁和腹壁的套管76，使用线环76来圈套丝线42以及将插管装置24的近端拉到外部。线环76可以简单的是一段用于穿过体内曲折路径的适当挠性的引导线，而不是用作圈套装置的必需的最佳方案。这是因为医生常常需要利用该丝线做成环，该环在置于体腔内时要保持打开，并且能够被控制以方便插入器械如插管装置24。穿过经皮套管的传统引导线环容易收缩，并且很难在体腔内定向。医生可能更青睐于穿过经皮套管插入圈套装置，该圈套装置当位于体腔内时形成相对较硬的具有可预知直径的环，并且可以围绕套管的轴线旋转，以便为将穿过环的器械提供最佳目标。
图21-23显示了改进的圈套装置82，其可以用于经皮套管，如图15-19中所示的套管76，以圈套患者体腔内的器械或者目标。圈套装置82可以包括细长的可弯曲部件84，该可弯曲部件84由与传统外科引导线相比相对较硬的弹簧材料形成。合适的弹簧材料包括不锈钢丝，具有生物相容性和耐腐蚀表面的硬质钢丝，镍-钛记忆金属丝，以及聚合物线。可弯曲部件84具有第一可弯曲部件端85和第二可弯曲部件端83。
圈套装置82还包括控制部件94，该控制部件94可以由，例如，由多种生物相容性材料中的任意一种形成的细线、线绳、天然纤维、外科缝合线或者细丝形成。控制部件94可以是挠性的或者刚性的，并且可以与可弯曲部件84相比相对较细，以便二者在伸直且彼此并排定位时能够容易地穿过套管76。控制部件94具有第一控制部件端95和第二控制部件端93。
第一控制部件端95可以通过联接件96可挠曲地连接到第一可弯曲部件端85，连接件96可以由例如粘结、捆绑、焊接或打褶形成。连接件96还可以是枢转、销接或者铰接连接。当拉力作用于第二控制部件端93时，推力同时作用于第二可弯曲部件端83，在第一可弯曲部件端89内不产生力耦合。
可弯曲部件84和控制部件94的长度可以改变，但是适当的长度是大约在20至50厘米的范围内。圈套装置82可以可选择地包括把手88，该把手88连接到第二可弯曲部件端83，用于操控、保持和/或施加作用力于第二可弯曲部件端83。
可弯曲部件84可以设置在正常直线结构或者正常弯曲结构。如图21所示，圈套装置82的远端部分98(显示为从套管76的远端部分延伸)可以在直线结构进入到体腔内。远端部分98的长度可以限定为等于环99的周长。如图22所示，推力可以作用于第二可弯曲部件端83，同时拉力可以作用于第二控制部件端93，以便可弯曲部件84的远端部分98形成为大致圆形的环99。环99的直径取决于从套管76的远端77延伸的远端部分98的长度。如果把手88被推到套管76的近端，如图22所示，并且可弯曲部件84和套管76的大致长度已知，则可以计算出远端部分98的大致长度以及环99的大致直径。
根据可弯曲部件84的挠性，当远端部分98的整个长度在形成环99之前伸入到体腔内时，或者当远端部分98的仅仅一小段长度在形成环99之前伸入到体腔内时，可以形成环99。在后一种情况中，连接件96可以仅仅稍微位于套管76远端77的远端。当使用者将推力作用于第二可弯曲部件端83时，远端部分98进一步从套管76中伸出而进入到体腔内，形成环99。环99的直径增加直到所有的远端部分98都已经从套管76中被推出。
当远端部分98形成图22所示的环99时，可弯曲部件84可以围绕套管76的轴线92旋转，如箭头97的指示。可选择地，把手88可以被键合到或者紧紧固定到套管76的近端，以便套管76和可弯曲部件84可以一起围绕轴线92旋转。在此方式中，环99可以定向以便为器械或者物体如丝线92穿过环98提供最佳目标。(如针对图16所述，内窥镜的远端可以在PEGJ手术中穿过环)。一旦目标被环绕，就可以除去在第二可弯曲部件端83上施加的推力以及在第二控制部件端94上施加的拉力，从而使得远端部分98弹回到直线结构，如图23所示。然后，圈套装置82可以从套管76中撤退，从而至少将被圈套目标(丝线42)的一部分拉出到外面。
图24是内窥镜20的远端部分，引导装置10以及总体以100表示的与引导装置10一起使用的另一实施例的插管装置的等轴测图。插管装置100，也称作结肠减压管，可以主要用于排出患者结肠内的流体如气体。插管装置100可以包括限定有贯穿通道108的细长管106。插管装置100还包括挠性导轨102(也称为匹配部件)，该挠性导轨102沿着管106的一部分长度或者基本上整个长度连接到管106或者与管106一体形成。管106合导轨102可以由挤压成型聚合物如聚氨酯形成，并且具有与图3中所示的插管装置24类似的横截面轮廓，但多种其他形状也是可以的。如同插管装置24，插管装置100可以适于和引导装置10的支架22或轨道16可滑动地接合。
插管装置100可以包括至少位于管106的远端部分且与通道108流体连通的多个空间间隔开的孔104。孔104的尺寸和形状可以明显变化，但通常要足够大以释放结肠中的气体。插管装置100的远端可以成锥形，如图24中所示，以便无创伤地插入到结肠中。插管装置100的近端(未图示)可以简单地是切割端，或者可以适于连接到流体收集系统(未图示)。插管装置100的长度可以至少能从患者的肛门延伸到结肠的盲肠，并且加上从患者的外部延伸而用于适当管理被释放或者排出的流体的附加长度。例如，插管装置的长度可以在大约100至200厘米的范围内。
图25-27显示了使用带有内窥镜的引导装置10，将插管装置100置于患者的结肠中，以便从结肠中释放和/或排出流体的方法。内窥镜20可以具有与之连接的图1所示的引导装置10，并且可以穿过肛门插入到结肠内。如图25所示，内窥镜20和引导装置10可以插入，直到内窥镜20的远端伸入到结肠内的理想部位，如结肠的盲肠内。
插管装置100可以沿着引导装置10前进，直到插管装置100的远端位于结肠内的理想部位，如图26所示。可选择地，在将内窥镜20插入结肠中之前，插管装置100可以与引导装置10滑动接合。插管装置100的远端可以在插入之前位于内窥镜20的远端附近，或者位于靠近内窥镜20远端的任意部位。
内窥镜20和引导装置10可以从结肠内取出，同时插管装置100的远端被保持在结肠内的理想部位，如图27所示。插管装置100的近端可以定位成用于自然释放气体，或者连接到流体收集系统。
虽然已经针对一些方面、变例和实施方式显示和描述了插管系统和方法，但应当理解，本领域技术人员可以进行一些修改。

Claims (10)

1.一种插管装置，其用于与具有细长轨道的引导设备一起使用，所述插管装置包括：
基本上为挠性的管，其具有穿过其延伸的细长通道；
与所述管连接的导轨，所述导轨基本上与所述细长通道对准；以及
组织支撑件，其设置在所述管的近端部分上并包括第一端部、第二端部和设置在第一端部和第二端部之间的多个臂，当所述第一端部和第二端部相互靠近时，所述臂径向向外挠曲，使得所述组织支撑件从收缩结构变化到展开结构。
2.根据权利要求1所述的插管装置，其特征为，所述组织支撑件在定位在患者的内部胃壁上时处于展开结构。
3.根据权利要求1所述的插管装置，其特征为，所述导轨适于可滑动地接合所述引导设备的所述细长轨道。
4.根据权利要求1所述的插管装置，还包括连接到所述管上的牵引细丝。
5.根据权利要求1所述的插管装置，其特征为，所述管在其远端上包括闭合的逐渐变细的尖端。
6.根据权利要求1所述的插管装置，还包括定位装置，所述定位装置具有可释放地连接到所述管上的第一连接部件，所述定位装置包括适于可滑动地接合所述引导设备的所述细长轨道的定位导轨。
7.根据权利要求6所述的插管装置，其特征为，所述定位装置适于在位于患者体内时与所述管分离。
8.根据权利要求1所述的插管装置，其特征为，所述多个臂围绕所述管沿圆周间隔开并且连接所述第一端部和第二端部，所述第一端部连接到所述管上，所述第二端部可滑动地保持在所述管上并且位于所述第一端部的近侧。
9.根据权利要求8所述的插管装置，其特征为，当所述组织支撑件处于所述收缩结构时所述多个臂相对于所述管基本上是平的，当所述组织支撑件处于所述展开结构时所述多个臂基本上弯曲并从所述管径向延伸。
10.根据权利要求1所述的插管装置，其特征为，所述组织支撑件由聚合物管形成。
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CA2582214A1 (en) 2007-09-22
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