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CN111921054B - 换气面罩 - Google Patents

换气面罩 Download PDF

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Publication number
CN111921054B
CN111921054B CN202010607839.7A CN202010607839A CN111921054B CN 111921054 B CN111921054 B CN 111921054B CN 202010607839 A CN202010607839 A CN 202010607839A CN 111921054 B CN111921054 B CN 111921054B
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mask
gas
nasal
ventilation
port
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CN111921054A (zh
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迈克尔·J·佩德罗
史蒂文·H·卡塔尔多
托马斯·M·雷利
赖安·G·雷德福德
大卫·M·凯恩
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Shunmei Group Holdings Ltd
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Revolutionary Medical Devices Inc
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    • A61M16/01—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes specially adapted for anaesthetising
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    • A61M16/0411—Special features for tracheal tubes not otherwise provided for with means for differentiating between oesophageal and tracheal intubation
    • A61M2016/0413—Special features for tracheal tubes not otherwise provided for with means for differentiating between oesophageal and tracheal intubation with detectors of CO2 in exhaled gases
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Abstract

本申请公开了一种鼻换气面罩，具有用以监测呼气末CO2呼出的单独端口，其被整合至所述面罩中以监测由鼻或口呼出的呼气末CO2。本申请还公开了一种CPR面罩，用于鼻对口和/或口对口复苏，具有经成型以覆盖受害者鼻和/或口的主体，所述面罩包括CO2吸收剂，用于至少部分地消除施救者呼出的被传递至受害者的CO2。

Description

换气面罩
本申请要求2014年8月20日提交的美国临时申请62/039,759、2014年11月12日提交的美国临时申请62/078,677以及2015年5月13日提交的美国临时申请62/161,041的优先权，其全部内容通过引证的方式并入本文。
技术领域
本发明涉及对麻醉面罩和换气面罩的改善。
背景技术
在手术过程中，病人通常会处于麻醉之下。最常用的输送系统由包含麻醉气体和氧气的罐，调节气体流量和病人呼吸的系统，以及确保病人气道能够呼吸、充氧和输送麻醉气体混合物的设备构成。在急救和/或选择性气道控制的过程中，换气面罩被用于将氧气提供给病人；所述选择性气道控制过程包括但不限于：在病人被麻醉以进行手术之前，在病人被麻醉时，当病人在手术或者处置过程中被镇定时，病人由麻醉恢复时，在病人由麻醉恢复之后，或者在病人需要输氧的任意情况中。然而，面罩换气的缺陷之一在于其需要提供者的手和病人的脸之间持续地接触，从而将面罩保持在恰当位置，并使病人保持在嗅探位置，从而确保氧气和麻醉气体不会泄露至空气内，并且病人的气道保持开放。如果提供者未使病人保持在嗅探位置，那么已知的上呼吸道阻塞的危险并发症就可能会发生。提供者需要执行持续地面罩保持和操纵的原因在于人体解剖学和生理学。当颌、舌头和上呼吸道的肌肉由于镇静剂和/或给予患者用于镇定的肌肉松弛剂和/或麻醉而松弛时，上呼吸道(口、咽、喉)可能会变成部分阻塞的，并可能完全闭合。其中，当病人的颌部下降并且舌头阻塞气道的时候，会导致打鼾(部分阻塞)或者窒息(完全无法使氧气通过上呼吸道进入肺内)。当提供者未能给予充分的麻醉或镇静时，或者其开始逐渐减弱并且病人开始移动时，存在另一个问题。这也可能会致使病人气道阻塞，因为病人的头部和颈部位置不再处于嗅探位置。病人在手术过程中的移动也是危险的，因为其可能导致外科医生犯错误，特别是在眼睛、耳朵、鼻子、颈部、头部和咽喉手术中。
另外，在手术过程中会出现需要对病人进行快速插管的情况。全面罩，即覆盖病人的鼻和口的面罩在急救情况下是成问题的，因为面罩必须要被移除以露出病人的嘴部，用于插管。然而，移除面罩也去除了氧气支持。如将在下文描述的，本发明在一个方面解决了现有技术的如上所述的和其它的缺点。
本发明的另一个方面涉及心肺复苏(CPR)面罩。
通常称为CPR的心肺复苏为一种急救措施，被实施以手动保护完整的脑功能，直至可以采取进一步的措施来恢复处于心搏停止状态的病人(在下文为“受试者”或“受害者”)的自主血液循环和呼吸。在没有呼吸的无反应病人中，例如在溺水受害者、或者电击或不正常呼吸例如无呼吸的受害者的情况中，CPR也适用。
CPR涉及至少两英寸深度的胸腔按压，并且以至少100次每分钟的速度进行，以通过手动泵送血液经过心脏并由此经过身体来产生人工循环。施救者还可以通过直接呼气到受试者口内，或者通过CRP面罩至受试者口和/或鼻内(总称“口对口”复苏)，或者使用将空气通过受试者的口和/或鼻推至受试者肺内的设备来提供呼吸。外部提供换气的方法称为“人工复苏”。目前的建议强调高质量的胸腔按压来人工复苏；然而，当与高质量胸腔按压相结合时，人工复苏潜在地为病人提供最大的益处。
常规CPR面罩由CPR提供者通过手来保持在恰当的位置，或者可以通过在受试者或受害者头部后面延伸的条带保持在恰当的位置。虽然CPR面罩可以帮助未在呼吸的个体或受害者的换气，但是当施救者提供口对口和/或鼻对口复苏时，所提供的空气包含大量的致命的CO2。正如将在下文所讨论的，本发明在另一个方面解决了现有技术如上所述的和其它的缺点。
发明内容
本发明在一个方面中提供了一种改善的换气/麻醉面罩，其克服了现有技术如上所述的和其它的问题。更特别地，提供了一种鼻换气/麻醉面罩，包括一个或多个偏置气体开口，用以允许提供者在直接喉镜检查和插管过程中具有口和气道的清晰视界，其由如下构成：换气端口，用于在麻醉过程中通过无创正压通气(NIPPV)供给氧气和其它气体，并且其被连接至可以测量鼻呼气末CO2的麻醉回路；鼻下方的口部开口端口，用于净化由病人的嘴呼出的麻醉气体和呼气末CO2；气体净化/呼气末CO2端口，连接至面罩内部的通道，其与鼻腔隔离开；和氧气端口，用于供给术后氧气。使所述面罩有多个袢扣或孔眼，优选三个或四个，用于将面罩缚至病人的头部，或者将面罩向下绑至手术台，例如根据我们共同未决的PCT申请PCT/US14/44934和共同未决的PCT申请PCT/US15/34277中所教导的。
在本发明的一种实施方式中，提供了一种鼻换气面罩，具有用于将氧气引入至所述面罩内的O2端口，换气端口和整合至或连接至换气端口的气体监测附件。在这种实施方式中，气体监测端口包括鲁尔锁(luer lock)。
在本发明的另一种实施方式中，提供了一种鼻换气面罩，在面罩的鼻部区域下方、并在病人的唇部区域上方具有外部开口，其允许由口呼出的气体被净化并输送至净化设备，所述面罩优选进一步包括用于使所呼出气体的一部分转移的净化管线，从而监测呼气末CO2，并且其中连接器优选设置在呼气末CO2监测管线拦截净化管线的位置处，有效地转移气流，导致相对于呼气末CO2管线的正压，由此允许气体由净化管线采样。
在这种实施方式中，面罩可以进一步包括麻醉医师控制的2通道、3端口阀，允许麻醉医师在分别监测呼气末CO2通过鼻和口呼出或者当阀对二者开启的时候同时监测它们之间切换，其中，当口呼气末CO2监测端口被选择的时候，呼气末CO2监测管线优选还用于在麻醉过程中净化其它换气气体。
本发明还提供了一种鼻换气面罩，具有袢扣或者孔眼，用于使面罩在前面连接至面罩固定器，或者与常规的麻醉面罩带在后面连接，所述面罩的特征任选地还在于一个或两个如下的特征：
(a)仅允许一个已接合的前-后头带被连接，其中后头带可被单独地连接至面罩，或者可以连接至面罩并随后连接至表面，其将防止病人头部和/或颈部的移动；或者
(b)使用头带将病人的头部紧固至支撑表面，其中病人的头部将保持在目标位置，并且当提供者改变头部和/或颈部角度的时候，支撑表面将保持在目标位置。
在本发明的又一种实施方式中，提供了一种鼻面罩，其特征在于一个或多个如下的特征：
(a)其中，面罩可用作为氧气输送面罩或者换气面罩，提供O2和麻醉气体并用于同时监测呼气末CO2；
(b)具有用于通过一个或多个端口来监测呼气末CO2的端口，其可在手术之前、在手术中和在手术之后用于CPAP；
(c)具有用于通过一个或多个端口来监测呼气末CO2的端口，其可以通过这样的方式而被连接至复苏袋，即病人的口和气道并不会由所述复苏袋阻塞，从而允许直接进行喉镜检查和插管；
(d)其中，所述面罩可在前面连接至面罩固定器，或者使用常规麻醉面罩带在后面连接；和
(e)具有用于将氧气引入至面罩内的O2端口，换气端口和整合或连接至换气端口的气体监测附件，其中气体监测端口优选包括鲁尔锁。
本发明还提供了一种麻醉面罩，具有内置式净化系统，用于收集在口和/或鼻附近泄漏出的麻醉气体。
在又一种实施方式中，本发明提供了一种用于颏下空间的下颏带，其连接至鼻面罩，用于施加压力以迫使穿戴者舌头抵靠柔软的上腭，并导致舌后空间的阻塞，由此减小或者防止气体由病人嘴部泄漏出来，并允许病人由鼻呼出，其中如果需要，在呼气以防止呼气阻塞的过程中，下颏带还能够释放压力。
在另一个方面，本发明提供了一种改善的CPR面罩，用于口对口和/或鼻对口复苏，并包括CO2吸收剂，其消除施救者或者提供者再呼吸受害者呼出的CO2。更特别地，本发明提供了一种CPR面罩，其包括构建至面罩或面罩入口内部的CO2过滤器或者吸收剂，用于吸收由施救者或提供者呼出的CO2。
也就是说，提供了一种CPR面罩，用于口对口和/或鼻对口复苏，包括经成型以覆盖受害者的鼻和/或口的主体，所述面罩包括CO2吸收剂，用于消除至少一部分由施救者呼出的被传递至受害者的CO2。
在一种实施方式中，CO2吸收剂被涂覆在面罩的内表面上。
在另一种实施方式中，所述面罩包括换气管，其中，CO2吸收剂位于换气管内。
在另一种实施方式中，所述面罩包括单向阀和/或带，用于将面罩保持至受害者的头部。
在一种实施方式中，所述面罩包括与受害者面部相适应的柔性外围。在这种实施方式中，外围可以包括柔软的、柔顺的空气囊，或者弹性可变形泡沫垫。
在另一种实施方式中，面罩包括生物过滤器，其被结合至面罩内部，或者接合至换气管内。
在本发明的又一种实施方式中，提供了一种如上所述的CPR面罩，其特征进一步在于一个或多个如下的特征：
(a)包括单向阀；
(b)包括带，用于将面罩保持至受害者的头部；
(c)其中，面罩进一步包括柔性外围，用于适应穿戴者的面部，其中，所述外围优选包括柔软的、柔顺的空气囊或者弹性可变形泡沫垫。
附图说明
结合附图，从下面的详细说明中可以看到本发明的其它特征和优点，其中
图1中的图1a和图1b为根据本发明第一实施方式的鼻换气面罩的主视图和俯视图；
图2为图1中的图1a换气面罩的内部视图；
图3a和3b为平面图，示出了位于病人头部上的根据本发明的换气面罩；
图4a和4b为类似于图3a和3b示出连接至面罩的下颏带的视图；
图5a和5b示出根据本发明具有呼气末CO2监测器的鼻面罩的替代结构；
图6为根据本发明的鼻面罩换气系统的替代结构的侧视图；
图7为根据本发明具有CO2监测器的鼻换气面罩的替代实施方式的平面图；
图8为根据本发明具有CO2监测器的鼻面罩的另一种替代结构的平面图；
图9为根据本发明第一实施方式的CPR面罩的部分截面图；
图10为根据本发明的CPR面罩的第二实施方式的侧视图。
具体实施方式
根据本发明第一实施方式的鼻换气面罩10在图1中的图1a和图1b中示出。最佳地，其包含四个气体开口，但是还可以包含少于或者多于四个。第一个为换气端口12，其在麻醉过程中或用于危重症病人NIPPV时供给O2和其它气体，并允许解救病人免于由鼻呼出的任意呼气末CO2。第二个为口部开口14，其位于鼻部下方，但是与由面罩形成的位于病人的鼻部上方的鼻腔相隔离。开口14的目的在于净化由病人嘴部呼出的麻醉气体和呼气末CO2。除了减小或者避免麻醉气体进入手术间并变成危害，其允许由病人肺部排出并从口部逸出的呼气末CO2被监测。第三开口为气体净化/呼气末CO2端口16，其通过面罩内部与鼻腔隔离的通道18连接至开口(参见图2)。包括任意呼出的呼气末CO2的气体通过端口16离开面罩，并通过管20引导至气体净化过滤器和呼气末CO2监测器32(参见图3)，所述监测器32对源自气体净化管线的气体进行采样。第四开口为O2端口22，其在麻醉过程中被解封，并且无论是在手术之前、手术过程中还是在手术之后，可被连接至O2源(未示出)。当O2被供给的时候，换气管就会与换气端口12脱离，从而使得呼气末CO2可由鼻呼出。位于鼻下方、围绕口部开口14的气体罩24如所示的延伸超过所述面罩。其任选地被包括以扩展面罩中口部开口14的影响，从而包含更大百分比的由病人呼出的气体。
所述面罩还包括三个孔眼或者袢扣60、62、64，或者四个孔眼或袢扣66、68、70、72(图7)，用于如下所述的连接下颏带或者头带，或者用于将带连接至手术台，如根据我们共同未决的申请PCT/US14/44934或者我们共同未决的PCT申请PCT/US15/34277所教导的。
在图2中描述了本发明的鼻换气面罩10的内部视图。换气端口12和O2端口22被连接至鼻腔26。口部呼出的气体由面罩外部的口部开口14行进经过气体通道18，并从位于净化设备和呼气末CO2监测器上的气体净化器和呼气末CO2监测端口16排出。气体通道18在病人的鼻和口区域上分离由换气面罩形成的鼻腔26。
当O2或O2和麻醉气体被供给至病人的时候，它们经过连接至换气端口12的换气通路28行进到鼻腔，在30处由虚影所示的盖密封氧气端口。在手术之后，盖30可由O2端口22移除，并且O2管线被连接至所述端口，将O2供给至病人。换气通路28由换气端口12移除，并且鼻腔26对大气开放，其中呼气末CO2可由鼻呼出。
用于鼻面罩换气/呼气末CO2监测器口部气体净化器/呼气末CO2监测管线的气体回路在图3a和3b中示出。图3a示出源自鼻腔26的鼻部气流，所述鼻腔26被连接至换气通路28和呼气末CO2监测设备32。图3b示出由口呼出的气体进入口部开口并流经气体净化管线到达回收设备34以及连接至净化管线的相关管线，并流至呼气末CO2监测设备。注意：到净化管线的开口应当相对于净化气体流呈约90°地设置，从而使局部压力高于开口垂直于气体流的情况。如果其为垂直的，那么由于负压梯度，负压将防止呼气末CO2监测管线从所述气流采样。
还参见图4a和4b，下颏带36也可被应用于颏下空间，连接至鼻面罩10，并施加压力以迫使舌头抵靠柔软的上腭，并导致舌后空间阻塞，其将帮助防止任何气体泄漏出病人的嘴部，并允许病人由鼻呼出。如果需要，下颏带36还具有在呼气期间释放压力的能力，以防止呼气阻塞，并允许呼气末CO 2和其它气体由口部释放出来。
在替代结构中，用于鼻面罩换气和呼气末CO2监测的气体回路在图5a和5b中描述。所述附图示出双向三端口阀40，其将鼻回路连接至呼气末CO2监测设备。麻醉医师决定哪个区域(鼻部区域，口部区域，或二者同时)应当监测呼气末CO2。
用于鼻面罩换气并监测源自口部气道的呼气末CO2呼出的替代结构的侧视图在图6中示出。请注意双向三端口阀40已在口部方向上翻转，用于对呼气末CO2进行采样。
鼻换气面罩还允许仅一个组合式前部-后部头带被连接，后部头带可单独连接至面罩，或者可以连接至面罩并随后连接至表面，其将防止病人头部和/或颈部的运动。当提供者改变头部和/或颈部角度时，通过使用头带将病人头部紧固至支撑表面，病人头部将保持在目标位置，并且支撑表面将保持在目标位置。
图7描述了本发明的又一种实施方式，其中，通过O2管线为病人提供氧气，所述O2管线连接至换气面罩上的O2端口。所呼出的气体通过换气端口12而被排至大气中，如图7中所示。如果病人由于麻醉而处于无意识的状态，那么就需要确保CO2会被呼出。这可以通过添加“T形”气体监测附件50来实现，其滑动至面罩换气端口12上。管状附件50的主体允许所呼出的气体被排至大气中。附件侧面为一管状开口52，标称上与所述侧面呈90°。该开口52的末端可以具有鲁尔锁，或者任意其它种类的紧固连接。如果连接至气体监测器的气体监测管线54被连接至气体监测管线界面，源自主气流的呼出气体可以通过该开口而被采样。
用于实现相同的气体采样特征的替代方法在图8中描述。在这种实施方式中，气体监测管线界面为面罩换气端口12的整合元件。在这种结构中，O2通过供给管线流至O2端口内，并且呼出气体通过换气端口12传递至大气中。换气端口12的侧面为管状开口56，标称上与所述侧面呈90°。该开口的末端可以具有鲁尔锁，或者任意其它种类的紧固连接。如果连接至气体监测器的气体监测管线被连接至气体监测管线界面，源自主气流的呼出气体可以通过该开口而被采样。
参见图9，示出根据本发明的另一个方面的CPR面罩的第一实施方式，其表示为110，用以影响施救呼气、口对口复苏或者任意其它需要急救呼吸辅助的CPR步骤。面罩110经成型以覆盖受害者的鼻部和/或口部，并包括柔软的和柔顺的外围112，用于在施加适度的力以获得紧密配合的面罩密封时，适应受害者的面部。典型地，面罩的外围112包括柔软的、柔顺的空气囊114或者弹性可变形泡沫垫等。
换气管116被连接至由面罩凸出的整体式入口端口118，空气可以通过其而由施救者通过呼气供给至所述管内。换气管116或者入口端口118典型地包括单向阀120，其允许空气通过管116进入面罩。换气管116及其相关的阀120可以与端口118整体地形成，或者可以是可替换的、一次性的元件或组件(图10)。
面罩110的内表面122由CO2吸附材料(例如活性炭或沸石)部分地涂覆。而且，例如蛇纹岩的特定矿物可有利地被采用。典型地，这些材料被选至最佳尺寸，并包封在过滤材料124中，结合至面罩110的内表面122。可替换地，面罩110的内表面122可以涂覆CO2吸收聚合物，例如包含煅制二氧化硅的聚乙烯亚胺等，如在2012年1月6日的Scientific American中第33页所记载的。
可替换地，如在图10中所示的，包含CO2吸收材料的CO2过滤器126可被结合至换气管116中。
在使用时，施救者将CPR面罩110放置在受害者的鼻部和/或口部上，以开始受害者的急救换气。施救者施加适度的力，以对受害者的面部获得基本上气密的密封，并且随后通过施救者呼气至换气管116内来提供换气。虽然施救者呼气包含CO2，但是绝大多数的CO2将通过CO2过滤材料而被去除。
面罩110可以形成为不同尺寸的，例如成人尺寸、青年尺寸和儿童尺寸，从而适应不同尺寸的面部。本发明CPR面罩的特征和优点在于显著地降低供给至受害者的CO2量。而且，所述面罩通过防止疾病的传播帮助保护处于急救情况下的受害者和施救者。
在不脱离本发明的精神和范围的情况下，可以对上述发明进行各种改变。例如，生物过滤器(在图10中以虚影示出的130)也可被结合至面罩或者换气管116中。另外地，面罩可以包括带132，用于将面罩缚至受害者的头部，从而使施救者免于不得不按压面罩至受害者的面部。其它的变化也是可能的。

Claims (15)

1.一种鼻换气面罩，包括：
主体，其具有形成鼻腔的内部、气体通道和外部开口，所述鼻腔经配置以覆盖病人的鼻子，同时使病人的嘴部未被覆盖；
O2端口，其流体地连接到鼻腔并被配置为将氧气引入鼻腔；
换气端口，其流体连接到鼻腔并且被配置为引导气体朝向或远离鼻腔；和
呼气末CO2端口，其通过气体通道流体连接到外部开口，
其中，所述外部开口适于排除佩戴者口呼出的气体，并且所述气体通道被配置为将口呼出的气体从所述外部开口引导至呼气末CO2端口。
2.根据权利要求1所述的鼻换气面罩，其包括气罩，所述气罩位于所述面罩的鼻部区域下方并且围绕所述外部开口，所述气罩延伸超过所述面罩以增强通过外部开口的麻醉气体的收集。
3.根据权利要求1和2中任一项所述的鼻换气面罩，其中所述呼气末CO2端口被配置为与监测管线连接，并且所述换气端口被配置为与不同于所述监测管线的换气管线连接。
4.根据权利要求1和2中任一项所述的鼻换气面罩，其中所述气体通道被配置为将口呼出的气体与所述鼻腔隔离。
5.根据权利要求1和2中任一项所述的鼻换气面罩，其中所述气体通道将鼻腔与病人的口区域分开。
6.根据权利要求1和2中任一项所述的鼻换气面罩，其中所述面罩包括气体监测附件。
7.根据权利要求1和2中任一项所述的鼻换气面罩，还包括配置为连接至所述O2端口并阻塞所述O2端口的可移除帽。
8.根据权利要求1和2中任一项所述的鼻换气面罩，还包括袢扣或者孔眼，用于使面罩在前面连接至面罩固定器，或者与常规麻醉面罩带在后面连接。
9.一种鼻换气面罩，包括：
主体，其具有形成鼻腔的内部、通道和外部开口，所述鼻腔经配置以覆盖病人的鼻子，同时使病人的嘴部未被覆盖；
第一端口，其流体连接到鼻腔并被配置为将氧气引入鼻腔；
第二端口，其流体连接到鼻腔并且被配置为引导气体朝向或远离鼻腔；和
第三端口，其通过气体通道流体连接到外部开口，并配置成与监测管线连接；
其中，外部开口适于排除佩戴者口呼出的气体，并且气体通道构造成将气体从外部开口引导至第三端口。
10.根据权利要求9所述的鼻换气面罩，其包括气罩，所述气罩位于所述面罩的鼻部区域下方并围绕所述外部开口，所述气罩延伸超过所述面罩以增强通过外部开口的麻醉气体的收集。
11.根据权利要求9和10中任一项所述的鼻换气面罩，其中所述第二端口被构造成与不同于所述监测管线的换气管线连接。
12.根据权利要求9和10中任一项所述的鼻换气面罩，其中所述气体通道被配置为将口呼出的气体与所述鼻腔隔离。
13.根据权利要求9和10中任一项所述的鼻换气面罩，其中所述面罩包括气体监测附件。
14.根据权利要求9和10中任一项所述的鼻换气面罩，还包括可移除的帽，该可移除的帽被配置为连接至所述第一端口并阻塞所述第一端口。
15.根据权利要求9和10中任一项所述的鼻换气面罩，还包括袢扣或者孔眼，用于使面罩在前面连接至面罩固定器，或者与常规麻醉面罩带在后面连接。
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