CN109937008B - 通气面罩 - Google Patents

通气面罩 Download PDF

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CN109937008B
CN109937008B CN201780070064.0A CN201780070064A CN109937008B CN 109937008 B CN109937008 B CN 109937008B CN 201780070064 A CN201780070064 A CN 201780070064A CN 109937008 B CN109937008 B CN 109937008B
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nasal mask
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迈克尔·J·佩德罗
托马斯·M·赖利
赖安·G·雷德福
戴维·M·凯恩
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Shengmaide Group Holdings Co ltd
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    • A—HUMAN NECESSITIES
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Abstract

鼻部面罩具有呼气铲，呼气铲固定在面罩的下部分附近，并且适于当面罩被戴上时覆盖患者的上唇。面罩包括用于对从患者的嘴部和鼻部排出到呼气末CO2端口的CO2的流量进行采样的端口，以及用于使从患者的嘴部和鼻部排出的CO2的流量平衡的基于压力的流阻器。

Description

通气面罩
技术领域
本发明涉及麻醉面罩和通气面罩的改进。
背景技术
在外科手术期间患者通常处于麻醉状态。最常见的输送系统包括容纳有麻醉气体和氧气的罐、调节气体流量和患者呼吸的系统以及确保患者气道的用于呼吸、加氧和输送麻醉气体混合物的效力的装置。通气面罩用于在紧急和/或非急需气道管理期间向患者提供氧气，这种情况包括但不限于：在患者被麻醉以进行外科手术之前；当患者在外科手术或手术过程期间被施用镇静剂时；当患者正在从麻醉中恢复时；在患者已从麻醉中恢复之后；以及在患者需要补充氧气的任何事件期间。然而，传统的通气面罩并不理想。
此外，在外科手术期间可能出现需要给患者快速插管的情况。全脸面罩，即覆盖患者的鼻部和嘴部的面罩在紧急情况下是有问题的，因为必须移除面罩以使患者的嘴部露出来进行插管。然而，移除面罩也会移除氧气支持。
在我们的共同未决的PCT申请No.PCT/US2014/44934、No.PCT/US2015/034277和No.PCT/US2015/044341(下文称为'934、'277和'341PCT申请)中，我们提供了改进型通气/麻醉面罩，这种面罩在一个方面通过提供组合面罩来克服现有技术的上述及其它问题，组合面罩包括鼻部部分或面罩和口部部分或面罩，它们分别限定鼻部腔室和口部腔室且彼此可拆卸地连接，其中鼻部面罩可以单独地使用或与口部面罩连接起来作为组合鼻部/口部面罩。我们还提供了带有一个或多个端口的鼻部面罩，以及用于将面罩保持在患者面部的各种带系统。我们还提供了带有一个或多个传感器的仅鼻部面罩，传感器用于感测呼气末CO2或其它气体，并且用于清除气体。参见我们的共同未决的PCT申请No.PCT/US16/037070(下文称为'070PCT申请)。这种组合鼻部/口部面罩和仅鼻部面罩可从亚利桑那州图森的革新医疗器械有限公司(Revolutionary Medical Devices,Inc.of Tucson,Arizona)购得，商标为SuperNO2
Figure BDA0002057409520000021
发明内容
本发明通过在鼻部面罩的底部附近提供呼气铲以便当面罩被戴上时至少部分地覆盖患者的上唇而提供了对诸如我们上述PCT申请中所描述的鼻部面罩的改进。呼气铲可以由柔性优选能弹性变形的材料形成，并且用机械的方式或用粘合剂固定到面罩。作为替代方案，呼气铲可以形成有唇部以配合在鼻部面罩的外表面中的匹配槽中，或者与面罩形成为一体。呼气铲是柔性的，以允许外科医生将呼气铲压缩或推开，以便在鼻部面罩保持在患者上的同时允许接入患者的嘴部。作为替代方案，呼气铲可以自身折叠起来，从而在鼻部面罩保持在患者上的同时留下了对患者的嘴部的接入。
在一个方面，本发明提供一种鼻部面罩，其具有呼气铲，呼气铲由柔性或能弹性变形的材料形成，固定在面罩的下部分附近，并且适于当面罩被戴上时覆盖患者的上唇。
在另一方面，呼气铲适于被压开以允许接入患者的嘴部。
在又一方面，呼气铲适于自身折叠起来以允许接入患者的嘴部。
在再一方面，面罩包括呼气末CO2端口，用于对从患者的嘴部和/或鼻部排出的呼出CO2进行采样。
在又再一方面，面罩包括通气端口，通气端口适于附接至麻醉机、通气机、过度充气袋或者其它通气或气体附件。
在又另外的方面，面罩进一步包括氧气端口，氧气端口适于连接至用于将氧气供应至面罩内部的氧气源。
在另一方面，面罩具有用于附接一个或多个面罩带的突片或孔眼。
本发明还提供一种给患者通气的方法，包括：提供鼻部面罩，鼻部面罩具有呼气铲，呼气铲由柔性或能弹性变形的材料形成、固定在面罩的下部分附近并且适于当面罩被戴上时覆盖患者的上唇；以及当需要时使呼气铲移开以提供对患者的嘴部的接入。
在方法的一个方面，将呼气铲压开以允许接入患者的嘴部。
在方法的另一方面，将呼气铲自身折叠起来以允许接入患者的嘴部。
在又再一方面，方法包括提供具有如上所述的呼气铲的鼻部面罩，以及通过使用呼气末CO2监测器对从患者的嘴部和/或鼻部排出的呼出CO2进行采样来监测呼气末CO2端口。
在又另一方面，面罩附接至麻醉机、通气机、过度充气袋或者其它通气或气体附件，或附接至用于将氧气供应至面罩内部的氧气源。
本发明还提供一种鼻部面罩，鼻部面罩具有呼气铲，呼气铲固定在面罩的下部分附近，并且适于当面罩被戴上时覆盖患者的上唇，其中，所述呼气铲包括：开口，其允许当面罩被戴上时接入患者的嘴部；和柔性翻盖，其布置在呼气铲的内表面上，用于封闭开口。在一个实施例中，开口包括孔或者一个或多个狭缝。
本发明还提供一种用于给患者通气的方法，包括：提供鼻部面罩，鼻部面罩具有呼气铲，呼气铲固定在面罩的下部分附近，并且适于当面罩被戴上时至少部分地覆盖患者的嘴部，其中，呼气铲包括适于允许接入患者的嘴部的孔；以及通过将功能工具推动穿过孔来接入患者的嘴部。
在一个实施例中，工具被移除，孔基本被翻盖关闭。
还提供一种鼻部面罩，鼻部面罩具有呼气铲，呼气铲固定在面罩的下部分附近，并且适于当面罩被戴上时至少部分地覆盖患者的嘴部，所述面罩进一步包括呼气末CO2端口，呼气末CO2端口用于对从患者的嘴部和鼻部排出的呼出CO2进行采样，其中所述呼气末CO2端口进一步设有用于与接口连接器连接的接口。
在一个实施例中，接口连接器包括鲁尔锁(luer lock)接口连接器。最后，本发明提供一种给患者通气的方法，包括提供如上所述的鼻部面罩，以及经由接口连接器将流体引入面罩的内部。
在一个实施方案中，流体包含镇静剂，如利多卡因(lidocaine)。
在另一实施例中，经由接口连接器添加的流体与面罩内的气体混合。
在再一实施例中，本发明通过提供使面罩的口部和鼻部CO2采样端口之间的流量基本上平衡的机构，提供了如上所述且具有口部和鼻部CO2采样端口的鼻部面罩的改进。
更具体地，本发明提供一种基于压力的流阻器，基于压力的流阻器位于面罩的鼻部腔室的内部，以通过改变作为鼻部腔室与口部腔室之间的差压的函数的阻力来基本上维持鼻部和口部采样开口之间的恒定流量。
在本发明的一个方面，提供一种鼻部面罩，鼻部面罩具有呼气铲，呼气铲固定在面罩的下部分附近，并且适于当面罩被戴上时覆盖患者的上唇，所述面罩包括：第一端口，其用于对从患者的嘴部排出的呼出CO2进行采样；和第二端口，其用于对从患者的鼻部排出的呼出CO2进行采样，所述面罩进一步包括基于压力的流阻器，基于压力的流阻器与所述第二端口连通，并且适于使从患者的嘴部和鼻部排出到呼气末CO2端口的CO2的采样流量基本上维持恒定。
在又一实施例中，基于压力的流阻器通过改变作为第一端口与第二端口之间的差压的函数的阻力而维持如(PB－PC)1/2/RBC所限定的恒定流量QBC来维持恒定流量。
在另一方面，基于压力的流阻器包括具有两个或更多个孔的歧管，两个或更多个孔在面罩的鼻部腔室与呼气末CO2端口之间连通，并且由于鼻部腔室与呼气末CO2端口之间的差压而发生流动。
在再一方面，歧管包括柔性膜，柔性膜根据压力而偏转并且改变对呼气末CO2端口的流动阻力。在这样的方面，偏转量δZ优选地随阻力RBC而变化，与差压PB－PC成正比。
在另一方面，最大流动阻力由柔性膜中的孔的几何形状限定，孔由于在柔性膜的中心开口而未被柔性膜阻挡。
在又一方面，当压力使柔性膜在Z方向上偏转时，柔性膜阻挡朝向柔性膜中的一个或多个孔的流动。
本发明还提供一种用于给患者通气的方法，包括提供鼻部面罩，鼻部面罩具有呼气铲，呼气铲固定在面罩的下部分附近，并且适于当面罩被戴上时覆盖患者的上唇，所述面罩包括：第一端口，其用于对从患者的嘴部排出的呼出CO2进行采样；和第二端口，其用于对从患者的鼻部排出的呼出CO2进行采样，所述面罩进一步包括基于压力的流阻器，基于压力的流阻器与所述第二端口连通并且适于使从患者的嘴部和鼻部排出到呼气末CO2端口的CO2的采样流量基本上维持恒定；以及将采样流量连接至呼气末CO2端口。
在方法的另一方面，基于压力的流阻器通过改变第一端口与第二端口之间的差压的函数的阻力而维持如(PB－PC)1/2/RBC所限定的恒定流量QBC来维持恒定流量。
在方法的又再一方面，基于压力的流阻器包括具有两个或更多个孔的歧管，两个或更多个孔在面罩的鼻部腔室与呼气末CO2端口之间连通，并且由于鼻部腔室与呼气末CO2端口之间的差压而发生流动。
在方法的再一方面，歧管包括柔性膜，柔性膜根据压力而偏转并且改变对呼气末CO2端口的流动阻力。在这样的方面，偏转量δZ优选地随阻力RBC而变化，与差压PB－PC成正比。
在方法的又再一方面，最大流动阻力由柔性膜中的孔的几何形状限定，孔由于在柔性膜的中心开口而未被柔性膜阻挡。
在方法的再一方面，当压力使柔性膜在Z方向上偏转时，柔性膜阻挡朝向柔性膜中的一个或多个孔的流动。
附图说明
本发明的其它特征和优点将从以下结合附图的详细描述中看出，其中
图1A至图1D分别是根据本发明第一实施例的包含呼气铲的鼻部面罩的前视图、后视图、俯视图和透视图；
图2是示出根据本发明的具有呼气铲的鼻部面罩用在患者身上时的透视图；
图3是类似于图2的视图，示出了呼气铲被压缩或推开以提供口部接入；
图4是类似于图2的视图，示出了呼气铲被折叠而移开以提供口部接入的鼻部面罩；
图5是根据本发明第二实施例的具有呼气铲的鼻部面罩的透视图，示出了进入口部的可选方法；
图6是类似于图5的视图，示出了如何使用图5的呼气铲来实现口部接入；
图7是本发明第三实施例的类似于图5的视图；
图8A、图8B和图8C是本发明的又一个、第四实施例的类似于图2的透视图；
图9是图2面罩的CO2采样端口的侧视剖视图；
图10是图2中的面罩的侧视剖视图；
图11是根据图2面罩的流体流动示意图；
图12A是根据本发明优选实施例的面罩的内部透视图；
图12B是图12A的鼻部面罩的柔性密封翻盖阀的放大图；
图12C是图12A的鼻部面罩的侧视剖视图；
图13A是图12B的密封件处于打开位置的侧视剖视图；以及
图13B是图13A的密封翻盖阀的类似于图13A的视图。
具体实施方式
如本文所使用的，“鼻部面罩”优选地包括与诸如我们上述'934、
'277、'341和'070PCT申请中所描述的鼻部面罩类似的鼻部面罩，尤其包括可从亚利桑那州图森的革新医疗器械有限公司购得的SuperNO2
Figure BDA0002057409520000061
图1A至1D是鼻部面罩10的前视图、后视图、俯视图和透视图，鼻部面罩10略微类似于我们上述PCT申请No.PCT/US16/37070的图16A至图16E中所描述的鼻部面罩，但具有呼气铲12，呼气铲12由柔性的优选能弹性变形的材料形成并且固定到面罩的下部分14。呼气铲14优选地具有0020至0050的OO硬度计硬度(OO Durometer Hardness)，2-10的肖氏A硬度，更优选地3-7的肖氏A硬度，最优选地约5的肖氏A硬度。材料越软越好。
还参见图2，面罩10还包括气体采样装置(在16处以虚线示出)，气体采样装置适于吸力附接至呼气末(“ET”)CO2端口18并适于从患者的口部呼气和鼻部呼气中抽吸气体样品。EtCO2歧管的一个开口20位于呼气铲12的后方，以便当患者戴上面罩时覆盖患者的位于鼻部面罩10外部的上唇，其中由气体采样装置16产生负压力(小于大气压的压力)。歧管的第二开口22位于患者的位于鼻部面罩内部的鼻孔下方，其中也由气体采样装置16产生负压力。当患者呼气时，口部呼气和鼻部呼气经由开口20、22被收集并继续经过歧管并离开与提供负压力的气体采样装置16相连的EtCO2端口。于是通过气体采样装置16来测量诸如CO2等气体的浓度水平。
通过麻醉机或另一通气装置(在24处以虚线示出)经由通气端口23对鼻部面罩内部腔室加压。来自患者鼻部的气流受到鼻部腔室内部的歧管开口的负压力而被抽吸。患者的嘴部处于大气压力，并且口部呼气的流动由呼气铲引导，在呼气铲处，该流动被气体采样系统所提供的负压力抽吸通过歧管开口。鼻部呼气和口部呼气的样品流过歧管，并从EtCO2端口18离开到达气体采样装置16。面罩10还包括氧气端口25，用于将来自从氧气源(在27处以虚线示出)的氧气供应至患者。
柔性呼气铲设计的一个益处是，如果外科医生需要接入患者的嘴部以采用诸如插管或内窥镜26等的装置，则可以通过该装置将呼气铲沿标称“y”方向弯曲或推动，从而提供对患者的嘴部的接入，如图3所示。
一个柔性呼气铲12设计的另一益处是，如果外科医生需要接入患者的嘴部，则存在双稳定状态：呼气铲12覆盖患者的上唇和/或嘴部，如图2所示，或者呼气铲12可以自身围绕标称“X”方向被折叠起来并且在呼气铲12不再覆盖嘴部的状态下保持稳定，如图4所示。这允许如图所示接近患者的嘴部，并且仍然可以收集鼻部EtCO2。一旦内窥镜26或其它装置从患者的嘴部中被移除，如果临床医生决定继续收集口部EtCO2样品，则可以将柔性呼气铲12围绕“X”轴展开，再次覆盖患者的嘴部，如图2所示。
完成鼻部面罩的是用于附接一个或多个头带(未示出)的突片和/或孔眼30。
参见图5和图6，在本发明的替代实施例中，呼气铲12A包括圆形孔50，圆形孔50被翻盖52覆盖，翻盖52在锚54处附接至呼气铲12A的内部。呼气铲12A的形状类似于图1至图4的呼气铲的形状，但不必由柔性材料制成。翻盖52和锚54以虚线示出，因为它们位于呼气铲12A的内部。翻盖50处于常闭位置，并且当面罩被患者佩戴时，通过面罩内的正压力将翻盖50保持抵靠在呼气铲12A的内表面上。
图6示出了诸如插入穿过孔50的插管或内窥镜26的功能装置，将翻盖52推到了一边，从而在允许连续的呼气末采样等的同时允许接入患者的嘴部。翻盖50是柔性的，以便基本上密封在功能装置的周围。当移除功能工具26时，孔50再次由翻盖50密封。
在另一实施例中，如图7所示，孔50由狭缝70代替，狭缝70由锚固在74处的柔性翻盖72支撑到呼气铲12B的内部。与孔50类似，狭缝70允许功能装置插入穿过呼气铲，从而当将呼气铲留在适当的位置来允许持续的呼气末CO2采样等的同时做出对患者的嘴部的接入。
关于图5至图6以及图7的实施例需注意的是，对于孔、狭缝和翻盖可以使用任何几何形状，以在将呼气铲留在适当的位置以便持续的呼气末CO2监测等的同时，允许喉镜、气管内导管、内窥镜或其它功能装置穿过呼气铲。由于翻盖的柔性，翻盖基本上密封功能工具的周围并且允许口部呼气的CO2的持续收集。当从呼气铲中移除工具时，翻盖再次关闭孔或狭缝。
本发明的又一实施例示出在图8A至图8C中。在该后一实施例中，EtCO2端口16具有鲁尔连接部80，从而为端口16提供了与具有鲁尔接口连接部82的其它装置，如注射器84连接的能力。因此，端口16可以用于输送容纳在注射器中的包括诸如利多卡因等的镇静剂的流体或气体。图8A至图8B示出了连接至EtCO2端口16的充满流体的注射器84，并且图8C示出了被挤压的注射器84，其中流体正在被排出到面罩的内部。流过O2端口、或通气端口86或两者的诸如O2等的气体将与所传送的流体混合，使其雾化，然后由患者吸入。
再次参见图2，如上所述，面罩10还包括气体采样装置(在16处以虚线示出)，气体采样装置呈吸力附接至呼气末(“ET”)CO2端口18的形式并适于抽吸来自患者的口部呼气和鼻部呼气的气体样品。EtCO2歧管的一个开口20位于呼气铲12的后方，从而当面罩由患者佩戴时呼气铲12覆盖患者的位于鼻部面罩10外部的上唇，其中由气体采样装置16产生负压力(压力小于大气压)。歧管的第二开口22位于在鼻部面罩内部的鼻孔下方，其中也由气体采样装置16产生负压力。当患者呼气时，口部呼气和鼻部呼气经由开口20、22被收集并继续经过歧管并离开与提供负压力的气体采样装置16相连的EtCO2端口。于是通过气体采样装置16来测量诸如CO2等气体的浓度水平。
还参见图9至图11，在使用中，口部呼气经由单个开口的孔20进入CO2端口，并且鼻部呼气经由单个开口的孔30进入CO2端口，如图2所示。CO2端口连接至CO2监测装置，CO2监测装置产生吸力，从而通过采样管线来收集呼气样品。面罩在非加压构造以及加压构造下操作，在非加压构造下，经由CO2端口25供应氧气，并且通气端口23通向大气，其中氧气和CO2呼气均逸出，在加压构造下，氧气经由通气端口并且还有可选的氧气端口进入面罩。然后，CO2呼气以及氧气经由通气端口23离开，该通气端口23连接至麻醉机、呼吸机、CPAP机或通气袋，如过度充气系统(hyperinflation system)上的通气袋。
经过管道的体积流量Q由等式1-5中所示的流体动力学定律控制。
Q＝πφ2V/4 等式1
ΔP＝ρfLV2/2φ 等式2
ΔP＝(8ρfL/π2φ5)Q2 等式3
Figure BDA0002057409520000101
Q＝ΔP1/2/R 等式5
其中：
Q＝体积流量(m3/min)
p＝流体密度(kg/m3)
φ＝管道直径(m)
V＝流体速度(m/min)
ΔP＝两点之间的差压(Pa)
f＝管道的摩擦系数
L＝管道长度(m)
R＝管道阻力(pa1/2-min/m3)
图2和图9至图11中所示的当前面罩10的流体流动模型具有4个节点，其各自的压力和流量限定如下：
节点A，作为通向CO2端口的口部开口的孔20的入口。
-孔20的直径，φa＝φCO2Port
-孔20处的压力，PA
-经过孔20的口部呼气体积流量，QAC
-从节点A到节点C的管道阻力，RAC
-从节点A到节点C的管道长度，LAC
节点B，作为通向CO2端口的鼻部开口的孔22的入口。
-孔22的直径，φb
-孔22处的压力，PB
-经过孔22的鼻部呼气体积流量，QBC
-从节点B到节点C的管道阻力，RBC
-从节点B到节点C的管道长度，LBC
节点C，CO2端口的从孔22离开而进入CO2端口之处附近的内部
-CO2端口的直径，φCO2Port
-节点C处的压力，PC
-经过节点C的体积流量，QCD
-从节点C到节点D的管道阻力，RCD
-从节点C到节点D的管道长度，LCD
节点D，CO2端口的出口(连接至CO2样品管线)
-CO2端口的直径，φCO2Port
-节点D处的压力，PD
-经过节点D的体积流量，QCD
每个节点之间的流量限定如下：
QAC+QBC＝QCD 等式6
QAC＝(PA-PC)1/2/RAC 等式7
QBC＝(PB-PC)1/2/RBC 等式8
QCD＝(Pc-PD)1/2/RCD 等式9
理想情况下，来自口部呼气和鼻部呼气的流量QAC和QBC相等，以便测量呼出的CO2。在非加压构造中，PA和PB均大致相等并且等于大气压。在这种构造中，通过适当地构造相关联的管道直径和管道长度，可以将相关联的节点间阻力RAC和RBC设计为相等。挑战在于，在加压构造中，面罩的鼻部部分PB被加压至相对于大气和PA的标称值10-15CM H2O。在这种构造中，RBC需要按比例大于RAC，以使QAC等于QBC。如果RBC没有增加，则QBC将大于QAC。对于未加压构造和加压构造两者为了使CO2采样所采用的口部流量和鼻部流量维持基本上相等，RBC必须作为PB的函数而变化以维持相等的流量。
如本文所使用的，术语“基本上平衡的流量”和“基本上恒定的流量”可互换使用，并且意指在约10％体积内，优选在约5％体积内，更优选在约2％-3％体积内的流量。
基于压力的流阻器的优选实施例示出在图12A至图12C中。在该实施例中，类似于上述面罩10的鼻部面罩100包括歧管102，歧管102具有两个或更多个孔104、106，这些孔将面罩的鼻部腔室连接至CO2端口18。还参见图13A和图13B，具有开口114的膜盘112在孔116上方对准，孔116覆盖歧管102，在给定压力PB下，鼻部呼气可以穿过歧管的孔114、孔116以及孔118进入CO2端口18。随着压力增加到PBcrit，膜盘112通过向上移动而在Z方向上偏转距离δZ。此时，从鼻部腔室11到孔118的流动被阻挡并且只能穿过孔116。结果，从鼻部腔室11到CO2端口18的流动阻力RBC增加。孔118和孔116的几何形状可以选择为，使得当膜盘112偏转量小于δZ时，由(PB－PC)1/2/RBC限定的流量ZBC是标称上恒定的并且基本上等于来自口部呼气的QAC。结果，采样流量基本上相等。
在不脱离本发明的精神和范围的情况下，可以在上文中进行各种改变。

Claims (20)

1.一种鼻部面罩，具有在内部形成的鼻部腔室、通气端口、呼气末CO2端口以及呼气铲，所述呼气铲固定在所述鼻部面罩的下部分附近并且适于覆盖患者的上唇，使得当所述鼻部面罩被戴上时经由所述通气端口对所述鼻部腔室加压并且所述呼气铲通向大气，所述呼气铲由柔性或能弹性变形的材料形成，使得所述呼气铲适于被压开或自身折叠起来以允许接入患者的嘴部，并且所述呼气末CO2端口包括：第一开口，所述第一开口位于所述呼气铲的后方以便覆盖所述患者的上唇并且用于对从所述患者的嘴部排出的呼出CO2进行采样；和第二开口，所述第二开口位于所述鼻部腔室中以便覆盖所述患者的鼻孔并且用于对从所述患者的鼻部排出的呼出CO2进行采样。
2.根据权利要求1所述的鼻部面罩，其中，所述呼气末CO2端口设置有用于与接口连接器连接的接口，和/或所述通气端口适于附接至麻醉机、通气机或者过度充气袋；和/或还包括氧气端口，其适于连接至用于将氧气供应到所述鼻部面罩的内部的氧气源。
3.根据权利要求1所述的鼻部面罩，其中，所述呼气末CO2端口设置有用于与接口连接器连接的接口，和/或所述通气端口适于附接至通气或气体附件；和/或还包括氧气端口，所述氧气端口适于连接至用于将氧气供应到所述鼻部面罩的内部的氧气源。
4.根据权利要求2所述的鼻部面罩，其中，所述接口为鲁尔锁。
5.根据权利要求1至4中的任一项所述的鼻部面罩，其中，所述呼气铲由具有0020至0050的OO硬度计硬度或者2-10的肖氏A硬度的柔性或能弹性变形的材料形成。
6.根据权利要求5所述的鼻部面罩，其中，所述柔性或能弹性变形的材料具有3-7的肖氏A硬度。
7.根据权利要求5所述的鼻部面罩，其中，所述柔性或能弹性变形的材料具有5的肖氏A硬度。
8.根据权利要求1所述的鼻部面罩，其中，所述呼气铲包括：开口，其允许当所述鼻部面罩被戴上时接入患者的嘴部；和柔性翻盖，其布置在所述呼气铲的内表面上，用于封闭所述开口。
9.根据权利要求8所述的鼻部面罩，其中，所述开口包括孔或者一个或多个狭缝。
10.根据权利要求1所述的鼻部面罩，其中，当患者戴上面罩时，所述第一开口位于所述呼气铲的后方以覆盖患者的上唇，并且所述第二开口位于患者的位于鼻部面罩内部的鼻孔下方。
11.一种鼻部面罩，具有在内部形成的鼻部腔室、通气端口、呼气末CO2端口以及呼气铲，所述呼气铲固定在所述鼻部面罩的下部分附近，并且适于覆盖患者的上唇，使得当所述鼻部面罩被戴上时经由所述通气端口对所述鼻部腔室加压并且所述呼气铲通向大气，所述鼻部面罩包括：第一开口，所述第一开口位于所述呼气铲的后方以便覆盖所述患者的上唇并且用于对从患者的嘴部排出的呼出CO2进行采样；和第二开口，所述第二开口位于所述鼻部腔室中以便覆盖所述患者的鼻孔并且用于对从患者的鼻部排出的呼出CO2进行采样，所述鼻部面罩进一步包括基于压力的流阻器，所述基于压力的流阻器与所述第二开口连通并且适于使从患者的嘴部和鼻部排出到呼气末CO2端口的CO2的采样流量实质上维持恒定。
12.根据权利要求11所述的鼻部面罩，其中，所述呼气铲是柔性或能弹性变形的并且适于被压开或自身折叠起来以允许接入患者的嘴部，和/或所述通气端口适于附接至麻醉机、通气机或者过度充气袋；或还包括氧气端口，其适于连接至用于将氧气供应至所述鼻部面罩的内部的氧气源。
13.根据权利要求11所述的鼻部面罩，其中，所述呼气铲是柔性或能弹性变形的并且适于被压开或自身折叠起来以允许接入患者的嘴部，和/或所述通气端口适于附接至通气或气体附件；或还包括氧气端口，其适于连接至用于将氧气供应至所述鼻部面罩的内部的氧气源。
14.根据权利要求11所述的鼻部面罩，其中，所述呼气铲由具有0020至0050的OO硬度计硬度或者2-10的肖氏A硬度的柔性或能弹性变形的材料形成。
15.根据权利要求14所述的鼻部面罩，其中，所述柔性或能弹性变形的材料具有3-7的肖氏A硬度。
16.根据权利要求14所述的鼻部面罩，其中，所述柔性或能弹性变形的材料具有5的肖氏A硬度。
17.根据权利要求11至16中的任一项所述的鼻部面罩，其中，所述基于压力的流阻器通过改变作为所述第一开口与所述第二开口之间的差压PB－PC的函数的阻力RBC而维持由(PB－PC)1/2/RBC所限定的恒定流量QBC，和/或所述基于压力的流阻器包括具有两个或更多个孔的歧管，所述两个或更多个孔在所述鼻部面罩的鼻部腔室与所述呼气末CO2端口之间连通，并且由于所述鼻部腔室与所述呼气末CO2端口之间的差压而发生流动。
18.根据权利要求17所述的鼻部面罩，其特征在于，包括以下特征中的一个或多个：
(a)所述歧管包括柔性膜，所述柔性膜根据压力而偏转并且改变对所述呼气末CO2端口的流动阻力；
(b)偏转量δZ的变化与差压PB－PC成正比；
(c)最大流动阻力由所述柔性膜中的孔的几何形状限定，所述孔由于在所述柔性膜的中心开口而未被所述柔性膜阻挡；以及
(d)当压力使所述柔性膜在Z方向上偏转时，所述柔性膜阻挡朝向所述柔性膜中的一个或多个孔的流动。
19.根据权利要求18所述的鼻部面罩，其中，偏转量δZ随阻力RBC而变化，与差压PB－PC成正比。
20.根据权利要求11所述的鼻部面罩，其中，当患者戴上面罩时，所述第一开口位于所述呼气铲的后方以覆盖患者的上唇，并且所述第二开口位于患者的位于鼻部面罩内部的鼻孔下方。
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