CN109200416A - 改进的人工气道 - Google Patents

改进的人工气道 Download PDF

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CN109200416A
CN109200416A CN201810916389.2A CN201810916389A CN109200416A CN 109200416 A CN109200416 A CN 109200416A CN 201810916389 A CN201810916389 A CN 201810916389A CN 109200416 A CN109200416 A CN 109200416A
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菲利普·斯图尔特·埃斯努夫
约翰·伯格
迈克尔·艾瑞克·勋伯格
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UMEDAES Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0409—Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及一种改进的人工气道。一种人工气道，包括具有近端和远端的气道管以及安装在气道管的远端处的罩件，其特征在于，气道管包括邻近其远端的弯曲部分和从弯曲部分延伸到气道管的近端的笔直部分，并且弯曲部分比笔直部分更加刚性。

Description

改进的人工气道
本申请是申请日为2012年2月2日，申请号为201280007131.1，发明名称为“改进的人工气道”的申请的分案申请。
技术领域
本发明涉及在外科手术中经常使用的类型的人工气道。
背景技术
存在很多形式的可用的人工气道。一种普通的形式具有结合到罩件(mask)的中空管，罩件通常包括可充气的套箍(cuff)，当插进时，套箍覆盖喉部开口并且围绕喉部开口提供有效的密封。麻醉气体然后可通过中空管而被供应到病人。
通常，管由塑料材料模制并且至少在一定程度上是柔性的。一些管是相当刚性地，而其它管更加地柔性或松软，并且从而其将在其自身重量下弯曲。
实质刚性的管能够在罩件的插进期间保持其形状，并且在此过程期间可被用作手柄。一些是轻轻弯曲的，但是能够进一步弯曲以适应需要用于坐落于硬的腭部和后咽上的形状。其它的气道管进行60至90度的弯曲以更加紧密地配合该解剖学角度。
更加柔性的管通常由软塑料或弹性材料例如硅酮橡胶或PVC制成，其允许管道容易地弯曲或松软。管通常使用螺旋线加固以防止由于剧烈的弯曲而阻塞。另外，线加固防止了万一病人在管上咬下时的破碎和阻塞。柔性管的优势在于其能够在气道就位以后而被容易地操纵，从而不与头部、颈部或口腔区域中的外科手术作业相抵触。由此，在头部和颈部外科手术以及耳、鼻和喉部外科手术时，具有柔性管的喉部罩件气道因为这些特征而是受欢迎的。这些管的缺点在于这些管由于管不能用作手柄而是难于插进的，这是因为在插进过程期间如果有任何压力被施加其上，则管是易于不受控制地弯曲的。对于这些气道的插进的建议的技术是使用(戴手套)的手指抓住并插进气道的罩件部分。这是不受麻醉师欢迎的。已经设计出各种的引入器以避免该需要，但是基本上都被证明是不受欢迎的。
发明内容
本发明的目的在于避免上述缺点。
广泛地说，本发明提供了一种人工气道，其具有含有刚性管和柔性管两者的特征的复合管。
更具体地，本发明提供了一种人工气道，包括具有近端和远端的气道管以及安装在气道管的远端的罩件，其特征在于，气道管包括邻近其远端的弯曲部分和从弯曲部分延伸到气道管的近端的笔直部分，并且弯曲部分比笔直部分更加刚性。
优选地，弯曲部分由第一材料模制，第一材料比模制笔直部分的第二材料较不柔性。
优选地，第一材料的邵氏A硬度是40至50，并且第二材料的邵氏A硬度是30至40。
优选地，弯曲部分和笔直部分是环形截面的。
优选地，弯曲部分的外径大于笔直部分的外径。
优选地，弯曲部分的外径在15至17mm的范围内。
优选地，弯曲部分的壁厚在3至3.2mm的范围内。
优选地，笔直部分的外径在11至13mm的范围内。
优选地，笔直部分的壁厚在1.4至1.5mm的范围内。
优选地，笔直部分包括支撑弹簧以有助于防止其阻塞。
优选地，弯曲部分和笔直部分是分开模制的并且然后连接在一起。
优选地，弯曲部分和笔直部分是通过共同模制而整体模制的。
优选地，弯曲部分的弹性模量实质上大于笔直部分的弹性模量。
优选地，当相等长度的笔直样品在一端被支撑并且侧向力被施加到另一端时，弯曲部分的样品的挠度是笔直管的样品的挠度的大约10倍。
优选地，弯曲管的样品的弹性模量是笔直管的弹性模量的大约1.5至5倍大。进一步优选地，该比率是大约2.5。
本发明的人工气道具有的优点在于，其能够以类似的方式插入到刚性的喉部罩件中。使用者能够抓住相对刚性的弯曲部分并将其用作用于插进罩件的手柄。插进以后，较柔性的笔直部分能够以与已知柔性的喉部罩件气道的管很大程度上相同的方式被定位以提供良好的外科手术进入。
另外，一旦插进，本发明的气道的罩件就被有效地稳定住，因为弯曲部分对着硬的腭部和后咽定位，并且从而其更不可能被不注意地放置，就像有时可能发生在具有完全柔性的管的已知设备上的。
本发明还提供了用于人工气道的气道管，气道管具有近端和远端以及使用时安装在气道管的远端处的罩件，其特征在于，气道管包括邻近其远端的弯曲部分和从弯曲部分延伸到气道管的近端的笔直部分，并且弯曲部分比笔直部分更加刚性。
优选地，所述弯曲部分由第一材料模制，所述第一材料比模制所述笔直部分的第二材料较不柔性。
优选地，所述第一材料的邵氏A硬度是40至50，并且所述第二材料的邵氏A硬度是30至40。
优选地，所述弯曲部分和所述笔直部分是环形截面的。
附图说明
现将参考附图进一步描述本发明，附图中：
图1是根据本发明构建的喉部罩件的示意性侧视图；
图2是罩件的底面视图；
图3是沿着线3-3的示意性纵向剖面；
图4和5是在理解管的物理特性中有用的图表；
图6示意性地显示了插进病人的本发明的人工气道。
具体实施方式
图1显示了根据本发明构建的人工气道2。气道包括罩件4和气道管6，管6在其近端处与阳型Leur连接器8装配在一起。罩件4包括可充气的周围套箍10，套箍10在使用中借助于充气线路12充气，充气线路12借助于插头14通向套箍的内部。罩件2优选地由硅酮橡胶模制而成。罩件的结构可以是与已知罩件相同或类似的并且因而无需详细描述。
本发明的气道管6包括弯曲部分16和相对的笔直部分18。如下将要更详细描述的，弯曲部分16以比笔直部分18更加刚性的方式模制。在本说明书中，提到部分18为笔直的意味着其被模制成直线的或者稍微弯曲的。然而，部分18的柔性使得其能够容易地弹性偏移，并且在该上下文中的词语笔直应该在该上下文中理解。
在一种实施方式中，如图3中所示的弯曲部分16的长度X为80mm左右，而笔直部分18的长度可以是210mm。典型地，长度的比率是1：3左右，但是其可以根据气道设备的尺寸而改变。
弯曲部分16优选地由硅酮橡胶或PVC模制，并且笔直部分18优选地由硅酮橡胶或PVC模制，因此其明显地比部分10更加柔性。笔直部分18优选地通过螺旋线加固(未示出)。用于提供螺旋线支撑的技术在现有技术中是已知的并且因而无需描述。模制弯曲部分16的材料优选地比被用于模制笔直部分18的材料更加刚性。典型地，用于刚性部分16的材料的邵氏硬度为40至50A，而笔直部分18的邵氏硬度为30至40A。弯曲部分16和笔直部分18两者优选地是圆形的内径和外径。弯曲部分16的壁厚优选地大于笔直部分18的壁厚。典型地，弯曲部分16的壁厚的范围在3至3.2mm，而柔性管的壁厚的范围在1.4至1.5mm。
可能地是，弯曲部分16和笔直部分18可以由相同的材料整体模制，并且不同的壁厚在管的这两个部件上提供了不同的刚度。
然而，优选地是，弯曲部分16和笔直部分18被分开模制，然后通过包胶模制、溶剂焊接、粘结或者其它技术连接在一起。如图3中最佳示出的，弯曲部分16的近端20有一些逐渐变细，从而其能够被插入到笔直部分18的远端22，因此部分16和18之间的过渡在内部和外部都相当地光滑。
还可能的是，气道管6可以通过使用已知的共同模制技术在模具的形成弯曲部分16的该部分中注射较硬的材料并且在模具的形成笔直部分18的该部分中注入较软的材料来被整体地模制。
本发明的设备2的原型已经被构建并且已经被发现具有预期的特性，即弯曲部分16比笔直部分18更不容易受到弯曲的影响。已经进行了对弯曲部分16和笔直部分18的挠度和弹性模量的研究。图4显示了能够计算中空管的惯性矩I的图表，其中D1是外径并且D1i是内径。惯性矩通过I＝(Pi÷64)(D1 4–D1i 4)给出。
对于典型的弯曲部分16，外径D1说成是16mm，而内径D1i是9.8mm。使用以上等式1，惯性矩I是2.764x 10-9m4。
典型地，对于笔直部分18，D1是12mm，且D1i是9.1mm。因此，使用以上等式1，惯性矩I是6.813x 10-10m4。
对于弯曲部分16和笔直部分18来说的最初两者都是笔直的每100mm长的材料样品长度然后在一端被夹持并且经受施加到另一端的横向力以测量挠度。在挠度测试中，自由端偏移5mm。在刚性样品的情形下，需要的力是25gms。在柔性样品的情形下，需要的力是2.5gms。这表明笔直部分18比弯曲部分16更容易受到弯曲的影响。从这些挠度测试中，能够计算管的弯曲部分和笔直部分的笔直样品的弹性模量的近似值。以下等式可被用于该目的：
其中，d是挠度，P是施加的力，L是长度，E是弹性模量，并且I是惯性矩。
使用以上的等式1和2，对于笔直样品，弹性模量可确定为在以下表1中的结果：
表1
因此，对于该原型来说，模量的比率为大约2.5。
将清楚的是，当弯曲部分16自身(而不是其笔直样品)经受弯曲力，例如图1中由字母P所示的施加在其近端的力P时，需要用于5mm挠度的力大于用于笔直样品的。在原型上的一个测试中，需要大约65gm的力以产生5mm的挠度，并且因此将理解，弯曲部分16的弹性模量是笔直部分18的弹性模量的至少五倍。
气道设备2可以制成不同的尺寸以用于处于不同年龄范畴的病人。以下表2显示了设备2的标称尺寸S以及RD1和长度X的典型值，如图3中所示。
表2
S Rmm D<sub>1</sub>mm Xmm
3 50 15.6 80
4 54 15.6 90
5 65 16.8 100
对于更大或更小的尺寸，大小是可以变化的。
另外，角度A典型地是100o左右。图6显示了应用于病人30中的人工气道2。使用时，气道2的使用者抓住弯曲部分16并将其通过病人的嘴部32插进且定位罩件4，使其包围喉部开口34。套箍10然后可被充气以形成在喉部开口上的密封。将看到，弯曲部分16的弯曲一般遵循病人的解剖学特征并且弯曲部分16的凸出侧对着后咽36定位，从而易于稳定罩件在病人中的位置。然而，笔直部分18可以在嘴部空腔中移动以允许外科手术中良好的进入。
对于本领域技术人员来说，很多修改将是明显的而不偏离本发明的精神和范围。

Claims (10)

1.一种喉部罩件人工气道，包括：
具有近端和远端的气道管；以及
安装在所述气道管的所述远端处的罩件，
其中，所述气道管包括邻近其远端的弯曲部分和从所述弯曲部分延伸到所述气道管的所述近端的笔直部分，所述弯曲部分和所述笔直部分是环形截面的，其中，所述弯曲部分和所述笔直部分是分开模制的，其中，所述弯曲部分比所述笔直部分更加刚性并且由第一材料模制，所述第一材料比模制所述笔直部分的第二材料较不柔性，并且
其中，所述弯曲部分的近端和所述笔直部分的远端连接在一起，其中，所述弯曲部分的近端逐渐变细，从而提供所述弯曲部分和所述笔直部分之间的光滑过渡。
2.根据权利要求1所述的喉部罩件人工气道，其中所述第一材料的邵氏A硬度是40至50，并且所述第二材料的邵氏A硬度是30至40。
3.根据权利要求1或2所述的喉部罩件人工气道，其中所述弯曲部分的外径大于所述笔直部分的外径。
4.根据权利要求3所述的喉部罩件人工气道，其中所述弯曲部分的外径在15至17mm的范围内。
5.根据权利要求4所述的喉部罩件人工气道，其中所述弯曲部分的壁厚在3至3.2mm的范围内。
6.根据权利要求3至5中任一项所述的喉部罩件人工气道，其中所述笔直部分的外径在11至13mm的范围内。
7.根据权利要求3至5中任一项所述的喉部罩件人工气道，其中所述笔直部分的壁厚在1.4至1.5mm的范围内。
8.根据权利要求前述权利要求中任一项所述的喉部罩件人工气道，其中所述笔直部分包括支撑弹簧以有助于防止所述笔直部分阻塞。
9.根据前述权利要求中任一项所述的喉部罩件人工气道，其中所述弯曲部分的弹性模量大于所述笔直部分的弹性模量。
10.根据权利要求9所述的喉部罩件人工气道，其中所述弯曲部分的样品的弹性模量是所述笔直部分的弹性模量的1.5至5倍大。
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CN103429291A (zh) 2013-12-04
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