CN106068139A - 气道插管装置 - Google Patents

气道插管装置 Download PDF

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CN106068139A
CN106068139A CN201480072822.9A CN201480072822A CN106068139A CN 106068139 A CN106068139 A CN 106068139A CN 201480072822 A CN201480072822 A CN 201480072822A CN 106068139 A CN106068139 A CN 106068139A
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throat
pneumatic duct
airway device
big envelope
chute
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CN106068139B (zh
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纳西尔 穆罕默德·阿斯拉姆·德
穆罕默德·阿斯拉姆·德纳西尔
简·伊丽莎白·肯普
安德鲁·尼尔·米勒
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Intersurgical AG
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Abstract

一种人用或动物用的气道装置(10)，包括具有第一端和第二端的气道管(12)，气道管的第一端由喉部封套(20)包围，该喉部封套配置为当就位时适配在患者的喉部入口上，其中，气道管的第一端设置有插管斜道(22)，该插管斜道配置为当就位时引导插入气道管的管子进入患者的喉部入口。

Description

气道插管装置
技术领域
本发明涉及医疗装置且可适用于喉部气道(airway device，导气管)装置，并涉及其制造方法。本发明特别适用于在对自然呼吸的人或患病的动物提供氧气和/或麻醉气体时使用的装置，以在手术操作或复苏过程中进行间歇正压通气(IPPV)，并在这种操作的过程中对患者进行插管。
背景技术
GB2393399(Nasir)描述了一种气道装置，其包括具有第一端和第二端的气道管，气道管的第一端由不可膨胀的喉部封套(cuff)和口腔稳定器包围，喉部封适配在患者的喉部入口上形成解剖配合，口腔稳定器适于防止气道装置在使用中的旋转运动或侧向运动(side-to-side movement)。
与可膨胀封套气道装置的使用相比，尽管这种气道装置提供了明显的改进，但是在操作过程中有时仍必须对患者进行插管。
已经进行了许多尝试来提供不仅在患者的喉部入口周围形成外部密封且用作引导件以允许插入气管内导管(endotracheal tube)的气道装置。然而，这种装置总是可以膨胀的，并非总是能够直接引导气管内导管进入喉部入口，而是会将气管内导管直接引入患者的食道，并且，会导致气道装置的气道管变得被堵住，切断对患者的供气。
发明内容
本发明的第一方面提供一种如在所附权利要求书中描述的气道装置。
因此，根据本发明的第一方面，提供一种人用或动物用的气道装置，其包括具有第一端和第二端的气道管，气道管的第一端由喉部封套包围，喉部封套配置为当就位时适配在患者的喉部入口上，其中，气道管的第一端设置有插管斜道，其配置为当就位时引导插入气道管的管子进入患者的喉部入口。优选地，该管子是气管内导管。
在现有技术装置中，例如在GB2393399(Nasir)中描述的装置，且如图1所示，当将气管内导管插入气道管时，气管内导管并不是沿循其自然曲率(其允许将气管内导管正确地插入喉部入口)，而是沿循气道装置的气道管的曲率。这通常导致气管内导管并不是进入喉部入口，而是沿着喉部封套的内部朝向装置的末端滑动，这会导致气管内导管和患者的喉部之间接触，甚至是将气管内导管插入患者的食道，这都是不可取的。
然而，在本发明中，气道装置设置有插管斜道，其确保气管内导管当插入气道管时沿循气管内导管的自然曲率，而不是气道管的曲率，且当气道装置位于患者体内就位时引导气管内导管进入患者的喉部入口。
优选地，插管斜道设置在气道管的背侧的内壁上。在替代方式中，插管斜道设置在喉部封套的背侧的内表面上。优选地，斜道成一定角度放置，以确保当装置位于患者体内就位时，当将管子插入气道管时，该装置位于患者解剖结构中的更高的地方，并被引导进入患者的喉部入口。
优选地，除了插管斜道以外，气道管的第一端具有更大的直径，从而比气道管的剩余部分宽。特别地，优选地气道管的腹侧的内表面是平的而不是弯曲的，以提供此加宽。这进一步使得气管内导管当插入气道管时沿循其自然曲率，而不是气道管的曲率，并与插管斜道一起工作。该加宽所产生的本质效果是，当气道管出现在封套的后部时，在气道管的第一端处张开。
优选地，插管斜道设置有通道或凹槽。优选地，通道或凹槽沿着插管斜道的全长从纵向斜道的第一端纵向地延伸至第二端。更优选地，插管斜道设置有多个通道或凹槽。提供插管斜道可减小喉部封套的内腔的深度，这意味着，该装置将次优地(sub-optimal，比最优方式略差地)插入，存在患者的气道变得部分地被堵塞的危险。提供该一个或多个通道或凹槽可确保，气流通畅地通过气道装置，进入患者的气道，而不会损害斜道的效果。
优选地，喉部封套的末端是细长的。优选地，喉部封套的末端在其后背侧上设置有凸起或凸块。当气道装置位于患者体内就位时，喉部封套的末端的细长特性与背侧凸起或凸块一起帮助提供改进的食道密封。通过提供改进的食道密封，患者胃部膨胀的危险减小，且回流进入患者气道的危险减小。
优选地，气道管的第二端的侧壁设置有补充气体入口。如果需要的话，补充气体入口允许对患者提供额外的氧气或其他气体。在WO2011131974(Miller)中已经描述了一种合适的补充气体入口。
优选地，封套是不可膨胀的且预先形成为适于在患者的喉部结构上形成解剖配合的形状。
优选地，喉部封套是预先成形的、用空气预膨胀的或预先用合适的流体填充的。最优选地，喉部封套是不可膨胀的，然而在替代方式中，喉部封套可以是可膨胀的。
在一个替代方式中，气道装置进一步包括口腔稳定器，其位于喉部封套和气道管的第二端之间的气道管上或其周围。如果提供的话，口腔稳定器可由与封套相同的材料形成，或由不同的材料形成，并且，在使用中帮助定位并保持装置的位置。
在一个特别优选的实施例中，如果提供的话，口腔稳定器形成为气道管的组成部分，进一步优选地，口腔稳定器、气道管和喉部封套均形成为整体单元。
在另一替代方式中，不提供口腔稳定器。
各种零件、部分或部件的肖氏硬度是本发明的一个重要特征。例如，喉部封套优选地由这样的材料形成，其具有的肖氏A级硬度是小于等于40，更优选地是000至20，最优选地是000至4。
优选地，如果提供的话，喉部封套和口腔稳定器的前腹部由具有基本上相同的肖氏硬度的材料形成。这简化了结构并确保该装置的所有与患者的软组织牢固接触的部分相对较软。
在另一优选实施例中，装置的后部或背部以及装置的前部或腹部由不同肖氏硬度的材料形成。这使得背部能够由比腹部更牢固的材料制成。
优选地，装置的后部或背部由肖氏A级硬度小于60的材料形成，更优选地25至45的肖氏A级硬度，最优选地30至40的肖氏A级硬度。
优选地，该装置进一步包括从封套的末端延伸至气道装置的第二端的胃管通道。
根据本发明的第二方面，提供一种人用或动物用的气道装置，其包括具有第一端和第二端的气道管，气道管的第一端由喉部封套包围，喉部封套配置为当就位时适配在患者的喉部入口上，其中，气道管的第一端具有加宽的直径或是张开的。
附图说明
现在将参考附图仅通过实例描述本发明，在附图中：
图1示出了现有技术的喉部封套的部分横截面图；
图2示出了根据第一实施例的喉部封套的部分横截面图；
图3示出了根据第一实施例的喉部封套的前腹部透视图；
图4示出了根据第一实施例的喉部封套的侧视图；
图5示出了根据第一实施例的喉部封套的后背视图；
图6示出了根据第一实施例的补充气体入口的侧视图；
图7示出了根据第一实施例的气道装置的侧视图。
具体实施方式
下面仅通过实例描述本发明的实施例。这些实例代表了将本发明应用于实践的最佳方式，这些方式是申请人目前已知的，尽管其并不是可实现此效果的唯一方式。
参考图2至图5，这些示出了根据本发明的第一实施例的气道装置10。气道装置10具有气道管12，该气道管具有第一端14和第二端16。第二端16可选地在15mm处结束，或以其他适合于连接到传统类型的麻醉呼吸系统的连接器18结束。在气道管的第一端14周围形成喉部封套20。在所示实施例中，喉部封套20是不可膨胀的，且其形状和轮廓适于与患者的喉部入口区域相对应。
气道管12的第一端14还设置有插管斜道22，其配置为当气道装置10处于患者体内就位时，引导气管内导管(或其他适用的管子或装置)通过气道管12，进入患者的喉部入口。插管斜道22确保气管内导管当插入气道管时沿循其自然曲率，而不是沿循气道管12的曲率，并且，当气道装置10处于患者体内就位时，引导气管内导管进入患者的喉部入口。
在所示实施例中，插管斜道22位于气道管12的后背侧的内壁上。在替代方式中，插管斜道22可改为位于喉部封套30的后背侧的内表面上。
除了提供插管斜道22以外，气道管12的第一端14具有更大的直径，从而比气道管12的剩余部分宽。在所示实施例中，气道管12的前腹侧24的内表面是平的，而不是弯曲的，以提供此加宽。这进一步使得气管内导管当插入气道管12时沿循其自然曲率，而不是沿循气道管12的曲率，并与插管斜道22一起起作用。
在所示实施例中，插管斜道22可选地设置有两个通道26、28，这两个通道沿着插管斜道22的全长从其第一端纵向地延伸至第二端。提供插管斜道22可减小喉部封套20的内腔的深度，这意味着，气道装置10将次优地插入，存在患者的气道变得部分堵塞的危险。提供通道26、28可确保，气流通畅地通过气道装置10并进入患者的气道，不会损害插管斜道22的效果。
在所示实施例中，与图1所示的现有技术装置相比，喉部封套20的末端30是细长的。另外，喉部封套20的末端30在其后背侧上设置有凸起或凸块32。当气道装置10位于患者体内就位时，喉部封套20的末端30的细长特性与背侧凸起或凸块32一起帮助提供改进的食道密封。通过提供改进的食道密封，患者胃部膨胀的危险减小，且回流进入患者气道的危险减小。
另外，在所示实施例中，气道管12的第二端16的侧壁已经设置有可选的补充气体入口34，更特别地，补充气体入口34形成为连接器18的一部分，然而，在替代方式中，其可与连接器18分离。如果需要的话，补充气体入口34允许对患者提供额外的氧气或其他气体。
在一个替代方式中，喉部封套是不可膨胀的且由任何合适的软塑料材料形成。通过肖氏A级硬度的优选的软度(硬度)范围，对于接触喉部入口的喉部封套的面来说，小于40的硬度是最佳的。通过一个优选范围，000至20的相同级别的值是优选的，000至4的范围是特别优选的。可通过在封套本身的主体内形成腔体或通道，来进一步适应喉部封套的软度。
在另一替代方式中，喉部封套可预先用流体填充，例如空气，或其他无毒气体，或无毒液体。在此上下文中，术语流体具有宽泛的含义，包括任何合适的气体、液体、蒸汽或其组合，并将由解剖学/麻醉学领域中的专家与材料专家一起来决定并设计。喉部封套将由这种材料构成，该材料将不允许一氧化二氮(麻醉气体)穿过材料中扩散至任何明显的量，使得将额外的腔内压力保持恒定。由此得出结论：对于所填充的流体和麻醉气体，喉部封套应基本上是不可透过的。
或者，喉部封套可由软的泡沫材料形成，或可用泡沫填充。在任一种情况中，这在喉部封套的面周围提供软的、可变形的但是成型的表面，以与喉部入口区域的解剖结构接合。这种泡沫填充的装置将使任何可能的对该区域中的结构的损坏减到最少，同时仍提供基本上完整的密封。
此外，在替代方式中，喉部封套在制造过程中预先用流体填充，在该情况中，封套的衬里应由不吸收麻醉气体(例如一氧化二氮)的材料制成，使得封套内的压力在使用过程中不上升。
在另一替代方式中，喉部封套可由适于吸收液体(例如水、粘液或血液，或类似液体材料)的材料形成，这样做时，尺寸变大，以巩固患者的喉部入口的解剖粘膜软骨结构。将由材料专家来选择这种材料，但是包括如在TAMPAX(RTM)卫生棉塞中使用的CRM(人造棉混合物)，或压缩的凝胶泡沫5。
在另一替代方式中，喉部封套可采用传统的、可膨胀的喉部封套的形式。形成可膨胀的喉部封套的技术是众所周知的，这里不需要描述。
最后，在又一替代方式中，喉部封套可以是空心的，但是在传统文字意义上是不可膨胀的，改为用正压通气来使喉部封套“膨胀”和自加压。
而且，在所示实施例中，已在喉部封套20和气道管12的第二端16之间的气道管12周围设置口腔稳定器36。口腔稳定器36帮助在使用中定位并保持气道装置10的位置。
在所示实施例中，口腔稳定器36形成为气道管12的组成部分，进一步优选地，口腔稳定器36、气道管12和喉部封套20均形成为整体单元。
在一个替代方式中，不提供口腔稳定器。
提供与气道管12隔开的胃管通道38，如果提供给封套20的末端中的开口，那么胃管通道38从连接器18附近的装置的第二端中的开口延伸。在使用过程中出现被动回流的情况中，胃管通道38允许检测到任何胃部吸出物。其还提供了插入小孔胃管(例如三腔管(Freka Tubes))的途径。
该装置可用如由材料专家选择的任何合适的塑料材料构成。无乳胶医疗级硅橡胶是一种优选的材料。封套的质地应该是软的，以避免对周围的组织产生过度伤害。在合适的地方，其他合适的用于构造此类型的装置的材料包括，但不限于，聚氯乙烯(PVC)、热塑性弹性体，例如苯乙烯类嵌段共聚物(例如苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯-丁烯-苯乙烯(SEBS))，以及热塑性烯烃混合物(TPO)、热塑性聚氨酯(TPU)、共聚多酯(COPE)、聚醚酰胺(PEBAX)及其发泡形式。
在合适材料的选择中包括的另一重要因素是透明度。理想地，结构的材料应是基本上清澈的或透明的。这使得麻醉师或手术员能够看到气道的内腔，以检查堵塞或其他问题。这种透明材料对于材料专家来说是已知的。

Claims (12)

1.一种人用或动物用的气道装置，所述气道装置包括具有第一端和第二端的气道管，所述气道管的所述第一端由喉部封套包围，所述喉部封套配置为当就位时适配在患者的喉部入口上，其中，所述气道管的所述第一端设置有插管斜道，所述插管斜道配置为当就位时引导插入所述气道管的管子进入所述患者的喉部入口。
2.根据权利要求1所述的气道装置，其中，所述插管斜道设置在所述气道管的背侧的内壁上。
3.根据前述权利要求任一项所述的气道装置，其中，所述气道管的所述第一端具有比所述气道管的剩余部分更大的直径。
4.根据前述权利要求任一项所述的气道装置，其中，所述气道管的腹侧的内壁是平的。
5.根据前述权利要求任一项所述的气道装置，其中，所述插管斜道设置有通道。
6.根据权利要求5所述的气道装置，其中，所述通道沿着所述插管斜道的全长从所述纵向斜道的第一端纵向地延伸至所述纵向斜道的第二端。
7.根据权利要求5或权利要求6所述的气道装置，其中，所述插管斜道设置有多个通道。
8.根据前述权利要求任一项所述的气道装置，其中，所述喉部封套的末端是细长的。
9.根据前述权利要求任一项所述的气道装置，其中，所述喉部封套的末端在其后背侧上设置有凸起。
10.根据前述权利要求任一项所述的气道装置，其中，所述气道管的所述第二端的侧壁设置有补充气体入口。
11.一种人用或动物用的气道装置，所述气道装置包括具有第一端和第二端的气道管，所述气道管的所述第一端由喉部封套包围，所述喉部封套配置为当就位时适配在患者的喉部入口上，其中，所述气道管的所述第一端具有加宽的直径或是张开的。
12.一种基本上如参考图2至图7在本文在前面描述的气道装置。
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