CN1553820B - 呼吸辅助装置 - Google Patents

呼吸辅助装置 Download PDF

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CN1553820B
CN1553820B CN028177940A CN02817794A CN1553820B CN 1553820 B CN1553820 B CN 1553820B CN 028177940 A CN028177940 A CN 028177940A CN 02817794 A CN02817794 A CN 02817794A CN 1553820 B CN1553820 B CN 1553820B
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nasal intubation
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格雷戈里·詹姆斯·奥尔森
马丁·莱基
尼尔·普赖姆
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Fisher and Paykel Healthcare Ltd
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Abstract

一种用于向新生儿进送呼吸用气体的鼻插管(100)，包括：一个总管，该总管包括腔室(10)、通向该腔室的气体入口(16)和气体出口(12)、和用于使气体通过该腔室从入口流向出口的低阻力通道；以及一对鼻叉管(116，118)，这对鼻插管与该腔室流体连通，而且每个叉管与入口的间距都相等，鼻叉管直接并列设置在通道内，以消除死角。

Description

呼吸辅助装置
技术领域
本发明涉及一种鼻插管，尤其涉及一种用于将连续的正气道压力(CPAP)输送给新生儿的鼻插管，但并非仅限于此。 
背景技术
某些个体需要供呼吸用的补充气体，例如空气、氧气或其它气体。这样的气体可以被自由进送和/或以一定的控制压力进行输送。这些气体还可以通过患者的嘴和/或通过患者的鼻子进行输送。鼻式进送系统具有下述优点：一般情况下，与支承在嘴上的装置或覆盖在嘴上的装置相比，其更加便于使用，而且侵入性也小一些。除了便于使用的优点外，这种鼻式装置仍然使人感觉很不舒服，因为这种装置需要将多根固定带横跨在面部上和/或围在头上，以将该装置固定到人体的呼吸腔上。此外，传统的插管不能在鼻孔周围形成适当的密封，这样就不能防止窒息情况的发生，而且也不能提供可刺激患者进行呼吸的高流量系统。这样，即使采用这种固定带，鼻式装置仍然经常从呼吸道内脱出。对于儿童、婴儿或不知道将鼻式呼吸装置(鼻式CPAP或鼻式插管)保持在合适位置上的重要性的老年人而言，这种问题尤其严重。 
我们知道，为使肺内的空气量保持最低水平而向人体输送足量的呼吸用气道压力是有好处的，而且还有治疗作用。如果空气量低于该最低水平，那么肺部就可能破裂，而对于这些患者而言，肺部的破裂极其危险，甚至是致命的。此外，背压也能够提高肺内的氧气水平并降低二氧化碳的数量。这样，还可以通过从血液内除去二氧化碳的方式来提高PH值，因为二氧化碳是一种酸。因此，我们发现：采用足够的压力(也被称为连续的正气道压力(CPAP))在保持自然呼吸时的最小空气量或肺内压力方面非常有好处。CPAP可通过鼻部连接部件(例如鼻插管)或通过支承在口部的部件或气管部件进行输送。 
许多CPAP装置都是公知的，包括：气管内导管、头部腔室、面部腔室、面罩、鼻叉管和鼻插管。尽管每种装置都各有优点和缺点，但是鼻插管仍然提供了一种用于产生CPAP和/或起到气流辅助作用的舒适的替代装置。现有技术中的鼻插管已经通过许多方式被公开，而且这些鼻插管分别采用了不同的方法将其固定到鼻腔通道上。美国专利3513844公开了一种鼻插管部件，该部件用一个可调的带子围在患者的头上。美国专利4106505公开了一种类似的装置，在该装置中，通向鼻插管的进送管道钩挂在患者的耳朵上并围在患者的头上。美国专利5477852公开了一种更为麻烦的装置，该装置设置有一个头带，该头带用于保持和固定鼻插管及与其相连接的进送管道。美国专利5271391公开了另一种插管，这种插管通过下述方式实现固定：将压敏胶带粘接到从该插管两侧伸出的进送管道上，从而将进送管道连接到患者的脸颊上，同时使该插管定位在进送管道和患者的脸颊之间。 
帽式装置还可用于将CPAP鼻式插管保持在合适的位置上。但是，这种方法一般将一定的压力作用于患者的鼻子和上唇上，这样就会使鼻子中心部分产生压迫性坏死。尤其敏感的个体就是儿童、幼儿或婴儿。这种帽式装置不能将鼻叉管充分固定在合适位置上，尤其是在婴儿床上活动或滚动的婴儿。在医院或疗养院所，服务员经常发现CPAP装置已经从患者的鼻子上脱落，这样就会导致窒息、饱和度下降、心动过缓或缺氧，缺氧是指血液中的含氧量已经很低并存在危险的现象。实际上，这些帽式CPAP装置的管道悬挂在患者脸颊的两侧，这就意味着：最舒服的躺倒位置在患者的背部。由固定部件作用于患者面颊上的压力会使其它部位感觉不舒服。 
其它现有的固定装置包括可直接连接到鼻子上的粘接部件。美国专利4823789公开了一种鼻插管固定带，这种固定带具有一个涂覆有粘接剂的薄片和一个用于固定鼻饲管的连接件，该薄片被加工成能够装配到患者鼻子上的结构形状。美国专利5156641也公开了一种类似的装置，该装置设置有一个固定绳索，该绳索的一端被粘接到患者的鼻子上，其另一端则固定着一个鼻饲管。美国专利5513635提供了一种设置有身体接合部分的固定部件，该部件通过一个从患者鼻子向下延伸的导管接合部分以粘接的方式跨接在患者的鼻子上。类似地，美国专利5682881公开了利用粘接泡沫垫固定到上唇上的结构，从而实现导管的定位。 
在美国专利3,643,660中，公开了一种一体式的鼻插管，其包括一个中空的管体和一对间隔设置的、曲线状细长的管形延长部分，而且中空的管体设置有一个上部平面或平面状表面，管形延长部分设置有多个用 于引导气流的外孔，上述延长部分以直角从平面状表面向上伸出。参照图2和3，由于入口400设置在一侧，因此，叉管402和404则具有略微不同的压力。这样，下游侧的叉管404就可能从上游侧的叉管402中重新吸入呼出的二氧化碳。 
在美国专利5,975,077中公开了一种插管，这种插管包括：一个气道，该气道喷出的气体与患者的鼻孔流体连通；和按照空气动力学设计的通道，这些通道分别用于输送周围的空气和注入的气体，以在患者的吸气和呼气过程中优化流体的流动特性。 
美国专利4,774,946公开了一种与一个细长的柔性管连接在一起的插管。鼻叉管包括多个球形部分，这些部分支承并密封着位于鼻孔内的鼻插管。 
美国专利5,193,532公开了一种用于通过喷射器的动作产生连续的正气道压力(CPAP)的装置，该装置包括一个呼吸通道，该呼吸通道的一端通向大气，其另一端适合于安装一个连接部件，该连接部件用来与患者的鼻子和/或嘴连接在一起，如图1所示。该入口定位于一个通向大气和通向叉管的通道之间，以使新鲜的气体能够主要以同轴方式进入该通道内，从而产生喷射动作。 
但是，由于这些现有技术只是提供了一种鼻式CPAP，因此其存在一些缺陷：不能充分固定到患者的头部上，每个叉管内的压力可能不平衡，可能将已呼出的二氧化碳重新吸入。 
发明内容
本发明的目的在于提供一种能够克服上述缺陷或至少给予公众一种有用选择的鼻插管。 
根据第一方面，本发明提供一种用于向新生儿进送呼吸用气体的鼻插管，包括： 
构造成与一个吸气导管相配合的气体入口； 
构造成与一个呼出导管相配合的气体出口； 
中空总管腔室，所述气体入口和所述气体出口通过所述总管腔室流体连通； 
一对鼻叉管，这对鼻插管在它们的基部流体连通地连接到所述总管腔室，每个鼻插管与所述气体入口的间距相等并且通过所述总管腔室与所述气体入口流体连通、以及与所述气体出口的间距相等并且通过所述总管腔室与所述气体出口流体连通； 
所述中空总管腔室在所述气体入口与所述气体出口之间提供低阻力通道，并且其内部构造成将所述鼻插管的死角限定到所述鼻叉管的容积，所述鼻叉管直接并列设置在所述低阻力通道内。 
在本发明所涉及的领域内，技术人员可在由所附权利要求书限定的保护范围内对本发明作出结构变化，提出差别很大的实施例并改变本发明的应用领域。上述内容和本文的说明仅是示例性的，而且没有任何限制的含义。 
本发明包括前述内容，而且还可设想下面给出的实例的结构。 
附图说明
下面将参照附图对本发明的一种优选方式加以说明，其中附图： 
图1为现有技术中的插管安装在婴儿身体上的侧视图； 
图2为现有技术中的插管安装在婴儿身体上的透视图； 
图3为现有插管的剖视图； 
图4为本发明从上方观看时的透视图； 
图5为本发明的剖视图； 
图6为本发明的透视图； 
图7为本发明的侧视图； 
图8为从下方观看时本发明的透视图； 
图9为从上方观看时本发明的透视图； 
图10是将本发明应用到婴儿身体上的视图； 
图11为与本发明一起使用的CPAP系统的方框图； 
图12为软帽的侧视图，软帽用于将本发明的鼻插管保持在位； 
图13为图12的软帽在应用于婴儿身体上时的视图。 
具体实施方式
现参照图11，图中示出了一种常规的应用情况。图中示出了一种加湿的连续正气道压力(CPAP)系统，患者19通过一个鼻插管100接收已被加湿的压力气体，鼻插管28与一个吸气导管21相连接。应该知道：本发明并非局限于对CPAP气体进行输送，而是还可以应用到其它类型的气体输送系统上。吸气导管21与一个加湿腔室10的出口12相连接，该加湿腔室内容纳有一定体积的水15。吸气导管21内可安装有一个加热部件或加热 丝20，该加热部件或加热丝20能够对导管壁进行加热，以确保沿导管恒定的湿度分布，从而减小加湿气体在该导管内的冷凝量。当对容纳加湿腔室10内的一定体积的水15进行加热时，水蒸气开始充满位于水面上方的加湿腔室10的空间，并且与由气体进送部件或风扇18吹出并通过入口16进入到腔室10内的气流(例如空气)一起从出口12流出加湿腔室10。 
参照图5和11，已被加湿的气体经吸气导管21流向插管100，该插管100通过叉管116、118与患者19的鼻子连通。呼出的气体通过叉管116、118流向输出总管130。接着，过量的气体就会流过呼出导管230。优选地，呼出导管23连接到压力调节器234。 
在本发明的优选实施例中，呼出气流排放到一个容纳有一定体积的水238的容器204内，如图11所示。流过呼出导管230的气体从一个由呼出导管延伸到容器204内的短管236排入水体238内。这样就会产生起泡作用，通过这种起泡作用就可通过出口252最终将气体从容器204内排出，该出口252还可用于在开始时将水装填到容器204内。该出口252包括防护部件，这种防护部件能够防止将由水面上的强力起泡作用而产生的液态气溶胶排出。应该知道：短管236也可以一体设置在呼出导管230的端部上。还应该知道：可通过调整短管236浸没在水体238内的高度实现对经插管100进送的气体的平均压力进行控制。 
鼻插管 
现参照图4至10，图中具体示出了鼻插管100。入口总管110连接到入口112。该入口可接收来自加湿器和空气/氧气混合器或其它合适的气流源装置的气流。该入口总管110的直径应尽可能地大，目的是确保在将气 体输送给患者之前使气体的压降最小。两个鼻叉管116、118与该总管流体连通。接着，气体就能够从入口总管110向上经鼻叉管流入患者的相应鼻孔内。叉管116、118本身为圆筒形，而且在顶部有一个逐渐变窄的微小锥形部分。其直径应仔细地选择，以使其能够基本密封鼻孔的内部，同时对鼻孔内部基本没有压力作用。除了密封作用之外，这样还能够产生一定程度的固定作用并将插管100保持在合适位置上。 
本发明的一个重要特征已经在图4中示出。两个鼻叉管116、118间隔一定的距离，该距离最好为新生婴儿的鼻孔间距。但是，本发明同样可被尺寸不同的所有患者所使用，而且可以很容易地对结构进行缩放。应该知道：尽管每个新生婴儿的鼻孔结构都存在一定的差别，但是隔膜(septum)一般都必然低于鼻侧的肉质部分。如在上面的现有技术中提及的那样，这样就会对隔膜造成刺激并使隔膜产生压迫性坏死。为避免这种情况，如图4和6所示，在两个鼻叉管116和118之间设置有切槽126或凹槽。该凹槽126被设计成不与隔膜相接触的结构形式。 
现参照图5，图中示出了插管100的剖视图。入口总管110与出口总管130被一个隔板132隔开，该隔板132在入口总管110与出口总管130之间水平延伸。该隔板132终止于叉管116和118的基部134附近。在该结构中，从入口总管110流出的至少部分气流总是直接流向出口总管130，如箭头170所示。由于入口总管110的直径尽可能地大、并且入口总管110和出口总管130的入口/出口位于隔板132每侧，存在从入口总管110到出口总管130的如箭头170所示低阻力通道。这样就可以保证将死角或呼吸容量限 定为叉管116、118的容积。这种结构能够降低淤积的二氧化碳量，而且还可以降低在插管100内产生冷凝的可能性。 
叉管116、118部分地由一种模铸橡胶或硅插件136制成，该插件通过与插管100的硬质塑料体138的干涉配合或压配合密封在插管100的硬质塑料体138上。叉管116，118可被用作一次性部件，或者易于在不同尺寸的部件之间进行互换的鼻罩、接口管或其它所需的接口部件。入口112形成为塑料体138的一部分，使入口总管110位于入口112的基部。入口112可适合装配用于市面上出售的导管的常规型连接结构。类似地，出口142与出口总管130流体连通。此外，还可设置一个传感器端口144，该传感器端口能够对输送气体的所有参数进行测定，例如压力、温度或湿度。如图7所示，入口/出口连接器154可被连接成用作鼻插管100与吸气导管21和呼出导管230之间的连接体。连接器154可由挤压的PVC或硅或者任何其它合适材料制成。传感器端口144也可与一个测量管156相连接，而该测量管156也可以形成为连接器154的一部分。 
头部的固定 
从图10至12中可以看出：插管100可通过软帽固定到患者19的头上。新生儿用软帽的优选形式包括一个头部覆盖部分330，该部分最好由具有隔热性能的可拉伸或弹性材料制成。合适材料的一个实例就是合成织物或棉质织物。头部覆盖部分330被设置成一个端部开口的管。如果用于覆盖部分330的材料沿一个主轴方向提供了更大的拉伸性，那么该主轴最好与该管状结构的整个纵轴对准。 
如图12所示，头部覆盖部分330具有开口端332，邻近开口端332的区域的刚性大于其它区域的刚性。区域331例如可以是一个改性织物形式的区域、由另一种材料或材料结构构成的套头、或者多层管体褶边。 
在覆盖部分330的外表面上设置有一个带子，该带子用于支承呼吸管或其它医疗用导管或管路。 
该固定部件是一个被缝在软帽上的带子333。该带子的一端连接有一个维可牢尼龙搭扣。如图10所示，外形为三角形的泡沫块334被装配在连接器154上。该泡沫块334定位在该带子333上。这样，该带子333就可围住该泡沫块并利用维可牢尼龙搭扣将其固定。该泡沫块334用于将连接器154固定到软帽330的合适位置上，以防止鼻叉管从鼻孔内脱出。替代地，如图13所示，如果不使用入口/出口连接器154，柔性管321可直接安装到头部覆盖部分330上。 
头部覆盖部分330的第二开口端347最好由一个简单的褶边构成。该开口端347最好可通过一个封闭部件340被封闭或保持在封闭位置上。该封闭部件340可包括另一个与固定部件333具有类似结构的束带或绳带。该束带或绳带340设置有两个支臂342、344。支臂342、344最好被系在一起或穿在一个套环上。 
使用时，头部覆盖部分330的端部347被捆扎成一个端部隆起341。环形束带或绳带340环绕在该隆起部分341上。该隆起部分341以封闭的结构形式被可靠固定在已经扎紧的环状束带或绳带340内。 
这样，当需要接近婴儿的头顶时，就可以通过封闭部件340而容易、有效地封闭或打开婴儿的软帽。例如，在做头部超声波检查或安装电极 时，就需要接触婴儿的头部。当需要接触头部时，可以将封闭部件340松开，从而使端部347的捆扎部分打开，这样就能够根据需要接触到头部。这种接触可在不干扰覆盖部分330的另一端332或用于将医疗用管或管路支承到位的固定部件333的前提下进行的。 
插管的固定 
患者19最好不要从嘴进行呼吸。吸气和呼气应该通过插管进行。在该优选实施例中，患者19的下颚被被保持闭合，以防止嘴部漏气。由于嘴部漏气会降低压力，从而降低CPAP的大小，因此最好不要发生嘴部漏气的问题。 
现参照图8至10，可以看到：插管100的基部利用带子150固定到患者19的头部上。该带子围绕患者19的颈部后侧并通过滑动杆152与插管100相连接。如图8所示，杆152通过钳夹或卡夹160固定到硬质塑料体138上。这使得当患者19扭转头部并在带子150上施加力时，杆152能够相对插管100相对横向和旋转移动。这样，无需扭转插管100就能够对插管100直接施加足够的约束力。杆152可以是塑料例如乙缩醛制品，啮合在塑料体138底侧的钳夹或卡夹160中。带子150上的张力可被调节至患者19舒适的水平。 
上述的内容是一种用于CPAP呼吸器上的改进型鼻插管。这种改进可降低由于采用这种插管而导致压迫性坏死或发炎的可能性。这种改进能够保证对两个叉管进行平衡进送，而且还使经总管流过死角区域的流量较高，这样就可以降低将已经呼出的二氧化碳重新吸入的可能性。 

Claims (9)

1.一种用于向新生儿进送呼吸用气体的鼻插管，包括：
构造成与一个吸气导管相配合的气体入口；
构造成与一个呼出导管相配合的气体出口；
中空总管腔室，所述气体入口和所述气体出口通过所述总管腔室流体连通；
一对鼻叉管，这对鼻叉管在它们的基部流体连通地连接到所述总管腔室，每个鼻叉管与所述气体入口的间距相等并且通过所述总管腔室与所述气体入口流体连通、以及与所述气体出口的间距相等并且通过所述总管腔室与所述气体出口流体连通；
所述中空总管腔室在所述气体入口与所述气体出口之间提供低阻力通道，并且其内部构造成将所述鼻插管的死角限定到所述鼻叉管的容积，所述鼻叉管直接并列设置在所述低阻力通道内。
2.根据权利要求1所述的鼻插管，其特征在于，所述鼻插管还包括固定部件，所述固定部件将所述鼻叉管固定到所述新生儿鼻孔内的合适位置上，所述固定部件包括颈部带子，所述颈部带子适合于围绕在所述新生儿颈部的背面并与所述插管相接合；
所述固定部件还包括软冒，所述软帽包括适合于至少部分覆盖新生儿头部的头部覆盖装置，所述头部覆盖装置包括至少一个使所述头部覆盖装置可靠定位在所述新生儿头部上的弹性套头；
在所述头部覆盖装置的外表面上设置有一个医疗用管的固定部件，所述医疗用管的固定部件构造成在使用时支承呼吸管或其它医疗用导管，以将所述呼吸管或其它医疗用导管在使用者头部上保持在位。
3.根据权利要求2所述的鼻插管，其特征在于，所述鼻插管还具有滑动杆，所述滑动杆适合与所述鼻插管的本体滑动接合，以使所述颈部带子相对于所述鼻插管移动。
4.根据权利要求3所述的鼻插管，其特征在于，所述颈部带子包括与所述滑动杆的可调连接，以便在使用时调节所述颈部带子的张力。
5.根据权利要求4所述的鼻插管，其特征在于，所述总管腔室被隔板分隔以在所述总管腔室中形成入口总管和出口总管，所述气体入口和所述气体出口位于所述隔板每侧，所述隔板一端在所述鼻叉管的所述基部附近终止，以形成所述入口总管的出口和所述出口总管的入口。
6.根据权利要求5所述的鼻插管，其特征在于，所述呼吸管或其它医疗用导管适合于在使用过程中与所述插管连接，所述医疗用管的固定部件可操作以防止在所述头部覆盖装置上的所述呼吸管或其它医疗用导管至少横向移动。
7.根据权利要求6所述的鼻插管，其特征在于，所述软帽由一种管状织物构成并在两端开口，所述固定部件与邻近所述两端之一的所述外表面相连接，端部封闭机构与邻近所述两端中另一端的所述外表面相连接，所述端部封闭机构可操作以将所述另一端的所述织物保持在封闭的、捆扎在一起的状态。
8.根据权利要求7所述的鼻插管，其特征在于，所述端部封闭机构包括一个被缝在所述软帽上的束带或绳带。
9.根据权利要求8所述的鼻插管，其特征在于，所述束带或绳带在其中心固定到所述软帽上以提供两个支臂，所述支臂穿过可在所述支臂上滑动的紧固套环。
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CA2370995C (en) 2010-08-17
WO2003022341A1 (en) 2003-03-20
EP1425060B1 (en) 2008-11-26
JP3962374B2 (ja) 2007-08-22
US20030047185A1 (en) 2003-03-13
ES2318062T3 (es) 2009-05-01
JP2005501669A (ja) 2005-01-20
ES2319832A1 (es) 2009-05-12
EP1425060A4 (en) 2005-02-02
ATE415182T1 (de) 2008-12-15
US7905232B2 (en) 2011-03-15
CA2370995A1 (en) 2003-03-13
EP1425060A1 (en) 2004-06-09
CA2457277A1 (en) 2003-03-20
US20040244804A1 (en) 2004-12-09
BR0212453B1 (pt) 2013-10-22
CA2457277C (en) 2009-11-24
BR0212453A (pt) 2004-10-19
AT500484A1 (de) 2006-01-15
CN1553820A (zh) 2004-12-08
AU2002334470B2 (en) 2005-01-20
DE60230048D1 (de) 2009-01-08

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