CN104254285A - 阻塞装置 - Google Patents

阻塞装置 Download PDF

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CN104254285A
CN104254285A CN201280055414.3A CN201280055414A CN104254285A CN 104254285 A CN104254285 A CN 104254285A CN 201280055414 A CN201280055414 A CN 201280055414A CN 104254285 A CN104254285 A CN 104254285A
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blocking device
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CN104254285B (zh
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戴维·克莱因
伊扎克·法比安
尼尔·阿尔特曼
史蒂文·哈斯
尤夫·希尔施
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EASYNOTES Ltd
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Abstract

一种阻塞装置(10)，包括安装在轴(14)的近端部分上的阻塞盘(12)，该盘包括内径向部分(16)和外径向部分(18)，其中，外径向部分比内径向部分更易弯曲。

Description

阻塞装置
技术领域
本发明总体涉及用于阻塞或减少通过体腔的流动的装置，特别地涉及用于阻塞或减少胃内容物流经幽门瓣的装置。
背景技术
已知胃手术用于治疗肥胖、胃食道逆流疾病(GERD)、癌症、糖尿病等。胃旁路术包括著名的Roux-En-Y手术，以及其它的缩小胃大小和/或在胃或胃肠道其它部分形成限制性屏障、另一路径、囊腔等的技术。这些外科手术可以通过使用例如胃镜的内窥镜工具来执行，虽然传统上它们通过使用开腔或最低限度侵入性外科器械来执行。
现有技术中，在胃手术或涉及十二指肠的手术过程中需要闭塞幽门时，外科医生钉住(胃中的)幽门，这是一个短期的闭塞以允许十二指肠从手术中恢复。已经提出横断幽门的装置，其可以局部和/或间断性阻塞幽门，因此减少胃内容物流入十二指肠。
发明内容
如在下文中更加详细地描述地，本发明旨在提供一种改进的用于阻塞或减少通过体腔的流动，特别是用于阻塞或减少胃内容物流经幽门瓣(幽门)的装置。本装置特别适用于经口胃肠道手术，但本发明不限于经口胃手术中，而是可以在其它腹腔镜的、内窥镜的或其它体腔自然开口的手术中使用。
本发明特别适用于阻止胃内容物流入包括十二指肠和空肠开始部分的近端内脏。例如，当开辟一条流经胃-空肠道并绕过近端内脏的另一路径后产生该需要。存在也会产生该需要的其它情形，例如在十二指肠区域或胰腺或胆汁流出到十二指肠处进行手术后。另外一种迹象可能是需要利用内窥镜对膨胀的胃进行胃手术。在这种情况下，塞子保持胃中的膨胀气体使它不膨胀肠。
因此根据本发明的一个实施例提供一种阻塞装置，其包括安装在轴的近端部分上的阻塞盘，所述盘包括内径向部分和外径向部分，其中，外径向部分比内径向部分更易弯曲。例如，内径向部分可以比外径向部分更具刚性。
根据本发明的一个实施例，轴包括一个或多个锚定部件(例如环)。
进一步根据本发明的实施例，内径向部分是半刚性的，而外径向部分是柔性的。
根据本发明的实施例，内径向部分比外径向部分延伸更大的区域。
根据本发明的实施例，外径向部分处于盘的外围边缘处。
根据本发明的实施例，盘被成形为贝勒维尔垫圈。例如贝勒维尔垫圈可以只包括外径向部分，或者包括内、外径向部分。
进一步根据本发明的实施例，抓握部件靠近盘设置在轴的近端部分处。
附图说明
根据结合附图的以下详细说明，将会更加全面地理解和认识本发明，其中：
图1A-1C分别是根据本发明的实施例构造和操作的阻塞装置的简化示意图、前视图和俯视图；
图2A-2C是将图1A-1C的阻塞装置引入到体腔(幽门)的简化图示；并且
图3A-3B分别是根据本发明的另一实施例构造和操作的阻塞装置的简化侧视图和图示。
具体实施方式
现在参考图1A-1C，图1A-1C示意根据本发明的实施例构造和操作的阻塞装置10。
阻塞装置10包括安装在轴14上的阻塞盘12。根据本发明的实施例，盘12包括内径向部分16和外径向部分18，其中外径向部分18比内径向部分16更易弯曲。在一个实施例中，内径向部分16比外径向部分18刚性更强。例如，内径向部分16可以是半刚性的，而外径向部分18可以是柔性的。在一个实施例中，内径向部分16比外径向部分18延伸更大的区域；例如，外径向部分18可以只在盘12的外围边缘处(具有例如但不限于小于2mm的半径宽度)。根据特别需要，盘12可以不渗透空气或其他流体。
在另一个实施例中，盘12被成形为贝勒维尔垫圈(Bellevillewasher)(图3A-3B也将示意其中盘成形为贝勒维尔垫圈的实施例)。贝勒维尔垫圈是在径向方向上大体上成弓形的垫圈。具体地，它们具有径向凸面(即，垫圈的高度不与径向距离线性相关，但可以例如在形状上是抛物线的)。贝勒维尔垫圈的恢复力与材料的弹性特征成比例。当压缩力施加到贝勒维尔垫圈时，力被导向成趋于径向扩展垫圈的环向应力。该环向应力由垫圈的材料强度抵消，材料的应变导致垫圈高度的偏转。等同地说，贝勒维尔垫圈通过压缩地偏转来响应压缩载荷，但在受环向应力的条件下提供与材料弹性模量成比例的恢复力。或者只有外径向部分18可以是贝勒维尔垫圈，或者内径向部分16也可以是贝勒维尔垫圈的一部分。
可以用于制造盘12的材料包括但不限于硅树脂、硅橡胶、乳胶、聚氨酯、PTFE(聚四氟乙烯)、FEP(氟化乙丙烯)等。在贝勒维尔垫圈的情形下，可以使用医用安全的金属，包括但不限于不锈钢、镍或钛。内径向部分16可以由与外径向部分18相同或不同的材料制成。
盘12能够折叠以通过内窥镜设备装入食道。折叠能力可以取决于仅外径向部分18的韧性，或者取决于内、外径向部分16和18两者的韧性。在到达体腔中的期望目的地之后，诸如置放在幽门中，盘12展开并密封地置放在体腔中。
在贝勒维尔垫圈的情形下，盘12最开始是弓形的，使得中央部分比外围更靠近端(或者可选的反之亦然，中央部分比外围更靠远端)。在该降低直径的构造中，垫能够更容易地插入在体腔中。在腔道中流向贝勒维尔垫圈的材料的力抵着贝勒维尔垫圈施加压缩力，这导致贝勒维尔垫圈变得扁平一些并增大其总体直径，由此密封体腔(例如幽门)。
盘12安装在轴14的近端部分上。在优选实施例中，盘12不在近端部分的最末端处；而是在轴14的近端末端处具有抓握部件20，可以抓握该抓握部件20以取出装置10。抓握部件20例如可以是球形凸起。
轴14作为远端的锚。在安装在幽门中的情形下，轴14置放在十二指肠中。在一个实施例中，轴14包括一个或多个锚定环22，该一个或多个锚定环22帮助将装置10保持在位。在安装在幽门中的情形下，环22可以帮助阻止装置10朝向胃浮回。不限制地，环22可以由硅树脂制成；轴14可以由封装在塑料管中的不锈钢或钛制成。当然，所有的部件都是生物相容的。在一个实施例中，环22是可膨胀或可扩展的(例如借助于形状记忆材料)。
现在参考图2A-2C，其示意将阻塞装置10引入到体腔(幽门)中。
如图2A所示，阻塞装置10可以安装在内窥镜装置26上并通过食道30进入到胃32中。如图2B所示，装置10的盘12将要对着幽门34的内壁放置，其中轴14指向十二指肠36中。图2C示出装置10锚定到位。
现在参考图3A-3B，其示意根据本发明的另一实施例构造和操作的阻塞装置40。
阻塞装置40包括安装在轴44上的阻塞盘42。根据本发明的实施例，阻塞盘42成形为贝勒维尔垫圈。盘42能够在插入期间向一个方向挠曲，而在取回期间向相反的方向挠曲。在另一个实施例中，阻塞盘42具有中心的远端顶点46。一个或多个支柱48设置在阻塞盘42的远端侧上。一个或多个锚定部件50设置在阻塞盘42的近端侧上。支柱48和锚定部件50可以由弹性材料制成，诸如但不限于关于顶点46(即，阻塞装置40的纵向轴线)对称放置的镍丝圈或环。锚定部件50足够结实以通过接触并轻微压靠在胃肠道(GI tract)的内壁上而将装置40锚定在胃肠道中，由此使装置40定中心并保持到位而不会对组织壁造成应变或损害。锚定部件50可以包括一对彼此正交的环，一个是经度方向部件，另一个是纬度方向部件。这种布置基本上是在胃肠道中自居中，这帮助使装置与幽门适当对准。
轴44(其可以称为装置的“颈”)不仅将盘42连接到锚定部件50上，而且充当盘42和锚定部件50之间的隔离件，其允许该两个部件很好地置于黏膜上。取决于应用，轴44能够具有不同的长度和厚度；例如，在幽门中，轴44的尺寸与幽门肌的通常宽度相关。
支柱48可以作为“保持环”或“抓握环”，当把装置插入到十二指肠或其它腔道中和从中取回时，其由抓握工具保持。
本发明的阻塞装置可以在多种应用中使用。例如，诸如当对远端大肠执行ESD(内窥镜黏膜下解剖)时，阻塞装置能够插入到大肠中以阻挡空气喷射到近端大肠。在另一个应用中，当进行活组织检查或在一些支气管手术时，阻塞装置能够部署在肺的支气管中。
本领域的技术人员应理解，本发明并不限于已经具体示出和在上文描述的内容。相反地，本发明的范围包括上文所描述的特征的组合与子组合，以及本领域的技术人员在阅读前面的描述之后将做出的和不在现有技术范围内的修改和改变。

Claims (15)

1.一种阻塞装置，包括：
阻塞盘，所述阻塞盘安装在轴的近端部分上，所述盘包括内径向部分和外径向部分，其中，所述外径向部分比所述内径向部分更易弯曲。
2.根据权利要求1所述的阻塞装置，其中，所述内径向部分比所述外径向部分更刚性。
3.根据权利要求1所述的阻塞装置，其中，所述轴包括一个或多个锚定部件。
4.根据权利要求1所述的阻塞装置，其中，所述内径向部分是半刚性的，而所述外径向部分是柔性的。
5.根据权利要求1所述的阻塞装置，其中，所述内径向部分与所述外径向部分相比在更大的区域上延伸。
6.根据权利要求1所述的阻塞装置，其中，所述外径向部分处于所述盘的外围边缘处。
7.根据权利要求1所述的阻塞装置，其中，所述盘成形为贝勒维尔垫圈。
8.根据权利要求1所述的阻塞装置，其中，所述阻塞盘具有中心的远端顶点。
9.根据权利要求1所述的阻塞装置，所述阻塞装置包括设置在所述阻塞盘的远端侧上的一个或多个支柱。
10.根据权利要求1所述的阻塞装置，所述阻塞装置包括设置在所述阻塞盘的近端侧上的一个或多个锚定部件。
11.根据权利要求10所述的阻塞装置，其中，所述锚定部件包括一对彼此正交的环，一个环是经度方向部件而另一个环是纬度方向部件。
12.根据权利要求1所述的阻塞装置，其中，抓握部件靠近所述盘设置在所述轴的近端部分处。
13.根据权利要求1所述的阻塞装置，其中，所述盘能够在插入期间在一个方向上挠曲而在取回期间在相反方向上挠曲。
14.根据权利要求1所述的阻塞装置，其中，一个或多个支柱设置在所述阻塞盘的远端侧上。
15.一种阻塞装置，包括：
阻塞盘，所述阻塞盘安装在轴的近端部分上，其中，所述盘成形为贝勒维尔垫圈。
CN201280055414.3A 2011-11-09 2012-11-08 阻塞装置 Expired - Fee Related CN104254285B (zh)

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