CN105056361A - 面罩系统 - Google Patents
面罩系统 Download PDFInfo
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- CN105056361A CN105056361A CN201510341597.0A CN201510341597A CN105056361A CN 105056361 A CN105056361 A CN 105056361A CN 201510341597 A CN201510341597 A CN 201510341597A CN 105056361 A CN105056361 A CN 105056361A
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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
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
- A61M16/0622—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
-
- A—HUMAN NECESSITIES
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- 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
- A61M16/0057—Pumps therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
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- 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
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
-
- A—HUMAN NECESSITIES
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A61M16/0683—Holding devices therefor
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A—HUMAN NECESSITIES
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A—HUMAN NECESSITIES
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- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
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- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/02—Gases
- A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
Abstract
本申请公开了一种面罩系统。用于面罩系统的护罩(1020)包括:固定部分,其构造为固定框架(1040);一对上头带连接器(1024),各自均包括伸长臂(1026)和在该臂的自由端处的适于接收头带绑带的狭槽(1027);以及一对下头带连接器(1025),各自均适于连接到头带绑带上。固定部分、上头带连接器和下头带连接器整体形成为单件结构。
Description
本申请是申请号为200980116004.3(国际申请号为PCT/AU2009/000241)、申请日为2009年2月27日、发明名称为“面罩系统”的专利申请的分案申请。
申请的交叉引用
本申请要求2008年3月4日提交的申请号为61/064,406、2008年5月23日提交的申请号为61/071,893、2008年9月19日提交的申请号为61/136,617的美国临时申请的利益,将其全部内容通过引用合并于此。
技术领域
本发明涉及用于采用持续气道正压通气(CPAP)或者非侵入性正压通气(NIPPV)对例如睡眠障碍呼吸(SDB)进行治疗的面罩系统。
背景技术
在睡眠障碍呼吸(SDB)治疗中,与送风机或流体发生器一起使用的、诸如全面部面罩或者鼻部面罩的患者接口典型地包括:软的面部接触部,诸如衬垫;和刚性或半刚性的壳或框架。在使用中,该接口通过头带被支持在密封位置,以使得正压空气供给(例如,2-30cmH2O)能被输送到患者气道。
治疗的功效和患者对治疗的依从性的一个因素是患者接口的舒适性和适配性。
本发明提供了面罩系统的可选配置以提高治疗功效和患者对治疗的依从性。
发明内容
本发明的一个方案涉及未设置适于接合患者前额的前额支架的面罩系统。
本发明的另一个方案涉及包括框架和可拆卸地连接至框架且适于与头带相连的护罩的面罩系统。
本发明的另一个方案涉及如下的面罩系统,其包括:框架,其限定呼吸腔室;衬垫,其设置于所述框架上并且适于与患者的面部形成密封;以及设置于框架上的护罩。护罩与框架是彼此共模制(co-mold)而成的。框架是由相对软且弹性的第一材料制成,而护罩是由比框架更具刚性的第二材料制成的。所述框架的至少一部分包括具有多个折叠的手风琴式部分(concertinasection)。每个折叠具有侧壁,折叠的侧壁远离患者面部逐渐变得更长。
本发明的另一个方案涉及衬垫模块,其包括限定呼吸腔室的框架和适于与患者的面部形成密封的衬垫。框架与衬垫是彼此共模制而成的。衬垫是由相对软且弹性的第一材料制成,而所述框架是由比衬垫更具刚性的第二材料制成的。所述框架的至少一部分包括手风琴式部分。
本发明的另一个方案涉及用于构造衬垫模块的方法。该方法包括:用相对软且弹性的第一材料模制所述衬垫模块的第一部件;用比所述第一材料更具刚性的第二材料将衬垫模块的第二部件共模制在第一部件上;以及将第二部件的至少一部分模制为包括手风琴式部分。
本发明的另一个方案涉及用于面罩系统的护罩,其包括:构造为固定框架的固定部分(retainingportion);一对上头带连接器,各自均包括伸长臂和在臂的自由端处的适于接收头带绑带的狭槽;和一对下头带连接器,各自均适于连到头带绑带上,其中固定部分、上头带连接器和下头带连接器整体形成为单件结构。
本发明的另一个方案涉及面罩系统,其包括:框架,其限定呼吸腔室;衬垫,其设置于框架上并且适于与患者的面部形成密封;护罩,其设置于框架上并且适于与头带相连;和肘管,其设置于框架上并且适于连接到将可呼吸气体输送给患者的空气输送管。护罩包括构造为建立护罩和框架之间刚性连接的固定机构。
本发明的另一个方案涉及面罩系统,其包括限定呼吸腔室的框架和设置于框架上的衬垫。衬垫包括主体和衬垫,其中衬垫适于接合患者面部的至少一部分。衬垫包括连接到底衬垫层的基壁和隔膜,其中隔膜绕着衬垫的周边延伸并接触患者面部。底衬垫层位于隔膜下面(underneath)并支撑隔膜。底衬垫层在面部的预定区域为隔膜提供不同的支撑。
本发明的另一个方案涉及医疗应用中使用的面罩组件,其具有由其相对于患者面部的位置所限定的顶端和底端,其中面罩组件连接到适于接合患者头部的多个柔性绑带上。柔性绑带接合至少两个整体模制到面罩组件的一部分上的刚性伸长臂,并且其中伸长臂是接近面罩组件的顶端而模制到面罩组件上的。
本发明的另一个方案涉及医疗应用中使用的面罩组件,其包括连接到衬垫的适于覆盖鼻部和/或嘴部的主体,其中面罩组件是通过基本垂直地朝向面部的力所附连的,其中所述力沿着面罩的长度是近似恒定的,并被所述衬垫的接合患者脸颊的一部分平衡。
本发明的另一个方案涉及与医用面罩一起使用的衬垫,包括:适于可密封地接合面部的外侧隔膜层;和适于支撑隔膜层的底衬垫层。隔膜或底衬垫层包括位于两个层之间的表面,所述表面适于允许这两层贴着相应表面滑动。
本发明的另一个方案涉及面罩系统,包括:框架,其限定呼吸腔室;衬垫,其设置于所述框架上并且适于与患者的面部形成密封;以及可释放的护罩,其适于接合框架的外表面的一部分,其中护罩连接到绑带上以定位面罩系统。
本发明的另一个方案涉及医疗应用中使用的面罩组件,包括:上端和下端,其中上端适于覆盖鼻部而下端适于覆盖患者嘴部。面罩组件不包括前额支架,而包括两个在面罩组件的相对侧连到上端上的加强构件(stiffenedmember),其中加强构件具有大体弯曲的形状和适于避免遮盖患者视野。
本发明的另一个方案涉及连到医用面罩上的衬垫,其中所述衬垫是柔性的并包括隔膜和至少一个底衬垫,隔膜连到衬垫的周缘上并适于相对患者面部密封,底衬垫适于支撑隔膜并位于隔膜下面以防止隔膜在使用中皱缩。隔膜比底衬垫软。当在底衬垫的底部和顶端之间进行测量时,底衬垫在鼻梁或下巴的区域中的高度在0mm和30mm之间。
本发明的另一个方案涉及医疗应用中使用的面罩组件,包括上端和下端,其中上端适于覆盖鼻部而下端适于覆盖患者嘴部。面罩组件不包括前额支架,包括两个在面罩组件的相对侧连到上端上的加强构件,其中加强构件具有大体弯曲的形状和适于避免遮盖患者视野。
在一可选实施例中,面罩系统可以包括构造为通过搭扣配合、机械互锁、摩擦配合和/或索环配置(例如用橡胶制成)连到框架上的头带连接器或者硬化件(rigidizer)。
在一可选实施例中,面罩系统可以包括具有用硅树脂和/或Breath-O-PreneTM材料制成的绑带配置的头带。
结合附图通过以下详细说明,本发明的其它方案、特征和优点将变得显而易见,其中附图作为本公开的一部分并且通过示例图示了本发明的原理。
附图说明
附图有利于理解本发明的各种实施例。在这些图中:
图1是根据本发明的一实施例的面罩系统的主视立体图;
图1B是示出图1的面罩系统的立体图,头带位于患者头部;
图1C是图1的面罩系统的剖视图;
图1D是图1的面罩系统的另一个剖视图;
图1E是图1的面罩系统的侧视图;
图2是示出图1的面罩系统的框架和衬垫的主视立体图;
图3是图1的面罩系统的分解立体图,示出框架、衬垫、护罩和肘管;
图4是图1的面罩系统的另一个分解立体图,示出框架、衬垫和肘管;
图5是图1的面罩系统的分解立体图,示出护罩和组装的框架/衬垫;
图6是示出图1的面罩系统的护罩的主视立体图;
图7是示出图1的面罩系统的衬垫的主视立体图;
图8是示出图7中的衬垫的一部分的剖视图;
图8B是图7中的衬垫的下巴区域和鼻梁区域的剖视图;
图9是根据本发明的一实施例的铺平的头带的平面图;
图10是根据本发明的另一个实施例的面罩系统的主视立体图;
图11是示出图10的面罩系统的框架的主视立体图;
图12是示出图10的面罩系统的框架的主视图;
图13是示出图10的面罩系统的框架的侧视图;
图14是示出图10的面罩系统的护罩的主视立体图;
图15是示出图10的面罩系统的护罩的主视图;
图16是示出图10的面罩系统的护罩的侧视图;
图17是示出图10的面罩系统的护罩的后视立体图;
图18-1至图18-2是以顺次关系示出图10的面罩系统的护罩连至框架的剖视图;
图19-1至图19-4是以顺次关系示出图10的面罩系统的护罩连至框架的剖视图;
图20是示出用于将护罩连到框架上的可选配置的立体图;
图21是示出图10的面罩系统的护罩的后视立体图;
图22是示出图10的面罩系统的护罩连至框架的剖视图;
图23是示出图10中的面罩系统的护罩、框架和肘管相连的剖视图
图24是示出用于将护罩连到框架上的可选配置的剖视图;
图25是根据本发明的另一个实施例的面罩系统的主视立体图;
图26是图25中的面罩系统的后视立体图;
图27是根据本发明的另一个实施例的面罩系统的主视立体图;
图28是在图27中示出的面罩系统的分解图;
图29是在图17中示出的面罩系统的放大的主视立体图;
图30是在图27中示出的面罩系统的侧视图;
图31-1是根据本发明一实施例的衬垫的后视图;
图31-2是局部剖视的图31-1中所示的衬垫的前视图;
图31-3是沿图31-1中的线31-3-31-3截取的剖视图;
图31-4是沿图31-1中的线31-4-31-4截取的截面图;
图31-5是沿图31-1中的线31-5-31-5截取的截面图;
图32-1至图32-3分别示出了根据本发明实施例的手风琴式部分的俯视图、主视图和侧视图;
图33是根据本发明的变型例的面罩系统的侧视图;
图34示出了根据本发明实施例的包括手风琴式部分的衬垫;
图35-1至图35-3是根据本发明另一个实施例的面罩系统的主视图、侧视图和后视图;
图36是用于根据本发明实施例的面罩系统的护罩的立体图;
图37-1至图37-3是根据本发明另一个实施例的面罩系统的立体图、主视图和侧视图;
图38-1至图38-5是在图37-1至37-3中所示的面罩系统的护罩的立体图、主视图、俯视图、侧视图和仰视图;
图39-1至图39-6是根据本发明另一个实施例的面罩系统的立体图、主视图、侧视图、仰视图和俯视图;
图40-1和图40-2是根据本发明另一个实施例的面罩系统的立体图和侧视图;
图40-3是在图40-1和40-2中所示的面罩系统的框架的立体图;
图40-4和图40-5示出了在图40-3中所示的框架的固定元件;
图40-6和图40-7示出了在图40-1和图40-2中所示的面罩系统的夹式上头带连接器;
图41-1和图41-2是根据本发明另一个实施例的面罩系统的后视和前视立体图;
图41-3和图41-4是在图41-1和图41-2中所示的面罩系统的分解图;
图41-5至图41-12是在图41-1和图41-2中所示的面罩系统的夹式上头带连接器的各个视图;
图42-1是根据本发明另一个实施例的面罩系统的后视立体图;
图42-2是在图42-1中所示的面罩系统的分解图;
图42-3至图42-7是在图42-1中所示的面罩系统的夹式上头带连接器的各个视图;
图43-1至图43-4是根据本发明另一个实施例的面罩系统的立体图、侧视图、主视图和后视图;
图44示出了根据本发明另一个实施例的面罩系统;
图45示出了根据本发明另一个实施例的面罩系统。
具体实施方式
以下描述涉及具有共同特性和特征的多个实施例或者示例而提供。应当理解的是,任何一个实施例或者示例的一个或者多个特征可以与其他实施例或者示例的一个或者多个特征相结合。另外,在任一实施例或者示例中的任何单个特征或者特征的结合可以构成额外的实施例或者示例。
在本说明书中,词语“包括”应当理解为其“开放”的含义,即,“包括…在内”的含义,因此不限于其“封闭”的含义,即“仅有…构成”的含义。所出现的相应的单词“包括了”“被包括”和“包括有”也有对应的意思。
采用术语“空气”以包括可呼吸的气体,例如具有补充氧气的空气。
采用术语“护罩”以包括部分地或者完全地覆盖阐述实施例中的第二元件的元件。在一实施例中,护罩可以包括部分地覆盖阐述实施例中的框架部件或者安装在框架部件上的元件。
采用术语“刚性连接(positiveconnection)”以包括阐述实施例中的元件之间的连接,其中安装在相应元件上的连接器适于分别彼此接合。
1、面罩系统
本发明实施例针对的是未设置适于与患者前额接合的前额支架的面罩系统。这种配置为面罩系统提供了较不突显(obtrusive)的配置,从而不会显著地影响患者的视野。虽然本系统设计成不需要前额支架,但是如果需要的话可以加上前额支架。
如下文将更加详细地描述的,面罩系统包括:框架;衬垫,其设置于框架上并且适于与患者面部形成密封;护罩,其设置于框架上并且适于与头带相连;和肘管,其设置于框架上并且适于连接到将可呼吸气体输送给患者的空气输送管。头带可以可拆卸地连到护罩上,以将面罩系统保持在患者面部上期望的调整位置。面罩系统意图用于对于具有阻塞性睡眠呼吸暂停(OSA)或者其他呼吸障碍的用户进行正压治疗。
虽然下文的各个实施例描述为包括全面部或者口-鼻接口类型,但是每个实施例适于与其他合适的接口类型一起使用。即,接口类型仅仅是示意性的,并且每个实施例适于包括其他接口类型,例如鼻部接口、鼻部面罩、鼻叉等。
2、稳定机构
根据本发明实施例的面罩系统的稳定机构(例如框架、护罩、具有相关头带矢量的头带)构造为适应从全面部型接口中去除前额支架。例如,前额支架典型地排除了面罩系统在矢状平面和冠状平面中的旋转,所以由于不存在前额支架,根据本发明实施例的面罩系统和头带构造为承担这些功能。
头带直接或者经由护罩连接到框架的顶部和底部,其中护罩为头带提供头带连接点,头带被定位和配置成将面罩系统稳定地保持在患者面部上的适当位置。
2.1框架
如图1、图1B-1E和图2-5所示,面罩系统1010的框架1040构造为将衬垫1060、护罩1020和肘管1070相对于患者面部保持在工作位置上。框架1040是用比衬垫1060(用例如硅树脂制成)更具刚性的材料(例如聚亚安脂)制成的(例如注模而成),但是其他材料也可以执行类似功能(例如聚碳酸酯)。在一实施例中,框架具有大约1-2mm、例如1.5mm的通常壁厚。
框架1040限定了适于容纳患者的鼻部和嘴部并为患者提供空气连通的呼吸腔室或腔体。框架1040的一个部分或者下部分包括适于容纳或反之适于连通肘管1070(例如旋转肘管)的开口1046,框架1040的另一个部分或者上部分包括用于气体冲洗的通气口装置1076。另外,框架1040的上部分包括适于对接(interfacewith)护罩1020或反之可拆卸地连接至护罩1020的对接结构(interfacingstructure)1048。
图27-30示出了包括具有衬垫44的框架40的面罩系统10,衬垫44提供了适于与患者的鼻部和/或嘴部形成密封的密封部分或者密封环。而且,框架40包括适于与肘管70连通的开口46。
2.2护罩
如图1和图3-6所示,护罩1020连接至框架1040,并被构造为将头带连到面罩系统上。在一实施例中,护罩1020是用包括但不限于塑料或者尼龙(例如尼龙12)的有弹性的材料制成(例如注模而成)的。但是,护罩可以由例如聚碳酸酯、聚丙烯、热塑性弹性体(TPE)、等其他适当的材料制成。在一实施例中,护罩具有大约1-2mm、例如1.3mm的通常壁厚。
护罩1020的顶端适于定位为接近患者鼻梁区域或者鼻部,而底端适于定位为接近患者嘴部或者下巴。顶端包括容纳从框架1040突起的通气口装置1076的开口或通气口接收孔1021,底端包括容纳肘管1070的开口或肘管孔1032,肘管通向框架1040(例如装配时护罩不提供与肘管的接触)。
上头带连接器1024从顶端的每侧延伸出,下头带连接器1025从底端的每侧延伸出。头带连接器1024、1025可以是整体模制到护罩上的或反之是连到护罩上的。
2.2.1上头带连接器
每个上头带连接器1024包括伸长臂1026和在臂1026的自由端处的适于接收相应的头带绑带的狭槽或接收孔1027。在使用中,臂1026在患者眼睛下方以大致凹角绕着患者面部延伸从而避开患者的视野,即引导头带远离患者眼睛。例如,如图1E所示,每个臂1026可相对于水平线以大约10-25°之间(例如17°)的角度α延伸。即,每个臂1026被适当地形成、定形或者定轮廓为遵循患者面部的轮廓并在使用中避开视线。在一实施例中,臂的形状可以是大体弓形,并适于在横跨患者脸颊的方向上延伸但是避开眼睛或者限制视野。在一实施例中,臂可以整体模制到面罩系统的护罩上。将臂模制到护罩上的一个潜在的优势在于:大大增加了可制造性,并且在臂意外断裂的情形下也可以容易地替换护罩而不是替换整个面罩系统。此外,将臂模制到护罩上也可以大大地增加连接的强度,并且减少或者限制臂断裂的实际可能性。
在一实施例中,臂1026是至少半刚性的(例如相对刚性的),从而防止臂相对于患者面部的上下移动或者弯曲。因此,臂1026可以充当硬化件以有效地充当水平仪配置(levelarrangement),并产生机械优势:其中施加于面罩系统顶端的力或者压力被重新调整至在面罩系统的顶端和底端之间的平衡中心附近的支点(fulcrumpoint)上。在一实施例中,臂相对于面罩系统被连到尽可能高的点以额外地稳定该结构。在一实施例中,支点或者枢转的力矩位于绑带的上和下连接点之间,并且其中臂1026的设计、角度、长度和/或结构可以有效地调整支点。在示出的实施例中,支点示出在面罩系统的通气口装置和肘管之间。此外,面罩系统当位于面部上时,其可以具有在患者鼻部的底部和唇部区之间的区域周围的或者在这个区域各处的支点。这个特征有效地将面罩系统稳定在患者面部上而不额外需要前额支架。
臂1026安装于在患者面部周围从面罩系统的顶端延伸出的位置的最终结果是:面罩系统更加稳固并且减小了使用中面罩系统在x轴1001(见图1)上受到的净扭力。请注意,臂1026可以在其他适当的位置刚性地连接到面罩系统以产生相似的结果。
在一实施例中,臂1026可以用来通过在脸颊处接触患者面部来稳定面罩系统。脸颊软垫可以设置在臂的内表面以在使用中将臂支撑在患者脸颊上。而且,臂1026可以被包封在软纤维衬套中以充当对于患者脸颊的额外加垫。软纤维衬套可以呈覆盖臂1026的一部分的弹性管的构造。
2.2.2下头带连接器
每个下头带连接器1025包括短缩臂和在该臂的自由端处的夹子插口1031,夹子插口1031适于与和相应头带绑带联接的头带夹子可拆卸地互锁。夹子允许更容易地定位或者戴上/去除面罩系统。在一实施例中,短缩臂和夹子也是相对刚性的,从而防止在使用中臂沿着y轴1002相对于面罩系统的横向移动。
图27-30示出了适于与夹子插口31可拆卸地互锁的示例性头带夹子33。如图28最好地示出的,每个夹子33包括:两个适于以搭扣配合(snap-fit)与相应夹子插口31互锁的弹簧臂35;以及适于在使用中接收相应头带绑带的狭槽37。
2.2.3可选的头带连接器
如图27-30所示的,臂26可拆卸地联结到护罩上,例如臂26包括适于与设置在护罩上的夹子插口可拆卸地互锁的夹子构造。这种配置允许不同类型的上和下头带连接器与护罩一起使用,例如用于上和下头带连接器二者的臂,用于上和下头带连接器二者的夹子,用于上和下头带连接器的不同长度的臂,等等。
但是,护罩可以设置其他用于与头带的头带绑带相连的适当配置。而且,护罩可以包括一个或者多个额外的元件,例如前额支架。
2.2.4头带连接器定位
在图1-6的实施例中,上和下头带连接器1024、1025提供了互相尽可能远离的头带连接点(即框架的顶部和底部)以允许更大的可调节性(例如允许在面罩系统的顶部和底部处的调节)和稳定性(例如锚定点分散在面罩系统周围所以更加稳固在患者面部上)。而且,上头带连接器被定位成尽可能地靠近面罩系统的顶部且在使用中不妨碍患者眼睛。
2.2.5单独的护罩
在图1-6的实施例中,护罩1020是单独形成的(例如,经模制而成)并连到框架1040上。这种配置便于护罩的模制;允许框架和护罩使用不同的材料(例如,为了稳定性框架可以是半刚性或者刚性的,具有头带硬化件的护罩可以是柔性的以用于调整);允许护罩隐藏在肘管/框架开口周围将肘管固定至框架的肘管保持元件(例如出于美观设置可视的护罩);允许框架不具有下夹子插口;允许护罩与不同尺寸的框架一起使用;以及允许护罩设计或者制作为最小化面罩系统的突显性。单独的护罩也可以允许头带、框架、衬垫和/或肘管的独自更换或者清洗。
2.2.6衬套
在一实施例中,软纤维衬套也可以安装在上和/或下头带连接器上。例如,衬套可以是弹性的,并适于在头带连接器的臂上面滑动以形成紧密配合。在一实施例中,衬套形成弹性管。衬套可以被加垫以在使用中增加面罩系统的舒适性。在头带连接器的臂接触患者皮肤之处,衬套会是尤其有用的,例如保护患者皮肤免受刺激。
2.2.7在患者耳朵上方延伸的臂
图35-1至图35-3和图36图示了根据本发明另一个实施例的用于面罩系统210的护罩220。护罩220包括构造为固定框架240的环形固定部分222和在固定部分222每侧的上和下头带连接器224、225。在图示的实施例中,护罩220被整体形成为一单件(例如见图36)。
在图示的实施例中,每个上头带连接器224包括伸长臂226和在臂226的自由端处的适于在使用中接收相应的后绑带298的狭槽227。如图所示,臂226被适当地定轮廓为:沿着脸颊并在患者耳朵上方刚好在患者太阳穴前面延伸,并将相应后绑带298固定在患者耳朵上方与患者耳朵呈隔开关系,例如以避免在使用中绑带摩擦或者刺激患者的耳朵。
而且,每个臂226构造为沿着头带的上绑带292延伸并在使用中与上绑带292相接合。如图所示的,每个臂226被稳固在上绑带292上以增加该绑带的刚性并在使用中将面罩系统稳定在患者面部上。此外,绑带292在使用中为患者面部上的臂226提供加垫。在一实施例中,上绑带292可以通过例如胶合或者缝制被固牢在臂226上。可选地,臂226可以被相应的绑带292包封或者插进相应的绑带292中以使得臂226基本上是看不见的。
每个下头带连接器225包括短缩臂228,狭槽229位于该臂229的自由端处并且适于在使用中接收相应的下绑带294。如图所示的,臂228被适当地定方位成将相应的下绑带294固定在患者耳朵上方与患者耳朵呈隔开关系,从而例如在使用中避免绑带摩擦或者刺激患者的耳朵。
在一实施例中,每个臂可以被连到面罩系统的上端,并且在患者视野或者眼睛下方弯曲,并且以大约10到20度之间的角度远离水平轴线向上弯曲。
在一可选实施例中,如图36所示,每个下头带连接器225可以包括夹子插口231,夹子插口231适于与和相应下绑带294联接的头带夹子(未示出)可拆卸地互锁。在一实施例中,头带夹子插口和夹子可以类似于雷斯梅德(ResMed)的MirageLibertyTM面罩上的头带夹子插口和夹子。在公开号为2007/014452和2006/0283461的美国专利中公开了示例性的夹子配置,将其全部内容并入到此处作为引用。
2.2.8不具有上头带连接器的护罩
图37-1至图37-3图示了根据本发明另一个实施例的面罩系统310。如图所示的,面罩系统310包括护罩320、框架340、衬垫344和肘管370。
如图38-1至图38-5所最好地示出的,护罩320包括构造为接收肘管370的开口322和在其每侧的头带连接器325。在图示的实施例中,每个头带连接器325包括适于与和相应下头带绑带联接的头带夹子(未示出)可拆卸地互锁的夹子插口331。
框架340可拆卸地连至护罩320,例如从开口322延伸出的指状件和突出部345适于接合框架340的凸颈圈(collar)。
框架340包括在其每个上侧的上头带连接器324。每个头带连接器324包括夹子固定器333,夹子固定器333适于与和相应上头带绑带联接的头带夹子(未示出)可拆卸地互锁。
图39-1至图39-6示出了面罩系统310的可选形式,其以相似的附图标记示出。如图所示的,框架340没有设置上头带连接器,每个夹子插口331包括可选的结构(例如,用于夹子上的搭扣配合突出部的孔)。而且,虽然图37-1至图38-5中的护罩320包括在相应的辅助端口343前方延伸的支撑杆329,但是在图39-1至图39-6中的护罩320包括构造为围绕相应辅助端口343的支撑杆329。
2.3头带
头带可以可拆卸地连到护罩1020的头带连接器1024、1025上,以将面罩系统1010保持在患者面部上的期望位置,例如见于图1B。
如图9所示,头带1090包括一对上和下绑带1092、1094,其中上绑带1092可拆卸地连到相应的上头带连接器1024上,下绑带1094可拆卸地连到相应的下头带连接器1025上。每个绑带的自由端可以包括粘扣,该粘扣构造为接合绑带的其余部分以将绑带稳固在适当的位置上。这种附件也允许调整绑带的长度。但是,上和下头带绑带可以任何其他适当的方式稳固到护罩上,例如通过可调节的梯状锁止配置等。
上绑带1092在患者头顶处分叉成顶绑带1096和后绑带1098,顶绑带1096(例如通过带扣而彼此连接)适于在使用中横过患者头的顶部,后绑带1098适于在使用中经过患者头的后面。在一实施例中,头带1090构造为是自支撑的。
在图9中,顶绑带1096适于通过带扣彼此连接。在一可选实施例中,如图27-30所示,头带90可以包括上和下绑带92、94、顶绑带96和后绑带98,顶绑带96彼此是整体式的。
上绑带1092设计成以与可调节前额支架改变面罩系统的位置相似的方式来调整面罩的位置,即将面罩系统的顶部移近或者移离患者鼻梁。
在不具有前额支架时,头带经由护罩1020连接在面罩框架1040的顶部和底部,而且为了避开眼睛和耳朵,上头带连接器的臂1026以一角度延伸。通过这样做,头带矢量V1和V2(见图1和图1B)调整成使得面罩系统可以具有戴在患者面部上的趋势(即上头带连接器将上头带矢量从水平线向上定位,下头带连接器将下头带矢量定位为大体水平)。通过上头带绑带1092在患者头顶分叉(即顶和后绑带1096、1098),可重新调整上头带矢量以防止面罩系统从患者面部滑落。
2.3.1头带调整
图35-1至图35-3图示了连到护罩的头带连接器224、225上以将面罩系统保持在患者面部上的期望位置的头带290。
在图示的实施例中,头带290包括一对上或者顶绑带292、一对下或者底绑带294和一对后绑带298。在使用中,上绑带292稳固到相应的上连接器或者臂226上,下绑带294经由狭槽229/夹子配置231可拆卸地连到相应的下连接器上,而后部绑带298经由狭槽227可拆卸地连到相应的上连接器上。上绑带292可以包括适于横过患者头的顶部并例如经由头带带扣或者可调梯状锁止配置299等彼此联结的上绑带部分。在图示的实施例中,下绑带294和后绑带298形成为一单件。
这种头带配置允许在三个位置发生调整,即上绑带292在头带带扣299处、下绑带294在狭槽229/夹子231连接处,以及后部绑带298在狭槽227连接处。
如图所示的,每个绑带的自由端可以包括构造为接合绑带的其余部分以可拆卸地将绑带稳固在适当位置的钩环扣295(例如)。这种钩环附件也便于调整绑带的长度。
在图示的实施例中,下绑带294和后绑带298适于在使用中在患者头部后面会合和经过(例如见于图35-3)。如图所示的,下绑带294以角度α会合(例如类似于在ResMed的MirageLiberty面罩中的底绑带)以防止绑带刺激患者颈部和/或防止由于在使用中患者颈部的移动而导致的绑带移动。
在一实施例中,头带可以类似于用于ResMed的MirageLiberty面罩中的头带,但是顶绑带经过了改进,并且不存在添加的硬化件系统。顶绑带可以类似于ResMed的Swift型头带,其中硬化件沿着两侧延伸。
2.3.2可选的头带材料
图43-1至图43-4图示了根据本发明另一个实施例的包括面罩615和头带690的面罩系统610。在图示的实施例中,头带690包括如下的绑带配置:其中一些绑带由硅树脂制成而一些绑带由Breath-O-PreneTM材料制成。但是,头带可以构造为使得绑带完全是由硅树脂制成或者完全由Breath-O-PreneTM制成。
如图所示的,头带的下绑带部分692是由Breath-O-PreneTM制成的,并且沿着脸颊和绕着患者头的后部延伸。头带的上绑带部分694是由硅树脂制成的并包括:侧绑带694(1),其沿着上脸颊并在患者耳朵上方延伸;顶绑带694(2),其在患者头的顶部上面延伸;后绑带694(3),其在患者头的后面延伸并连接到下绑带部分692(见于图43-4);和连接部分694(4),其在患者耳朵前方从相应的侧绑带694(1)延伸出并连接到下绑带部分692。
头带绑带可以任何适当的方式连接到面罩上。例如,在图示的实施例中,下绑带部分692通过头带夹子配置而连接到面罩上,上绑带部分694使用在其每端具有带扣部分的伸长带扣695而连接到面罩上。
在一实施例中,头带绑带配置成使得由头带施加给面罩的力矢量基本上垂直于面罩并且基本上相互平行(例如,如图43-2中的箭头所示)。这种配置增强了面罩密封,因为头带直接将面罩推到患者面部。
3、密封件
面罩系统的密封件(即衬垫)构造为适应从全面部型接口去除前额支架。
3.1衬垫
如图1-5至图7-8所示的,衬垫1060构造为与框架1040对接,并在使用中与患者的鼻部和嘴部形成密封。在图示的实施例中,衬垫是全面部衬垫,其适于大体上沿着患者面部的鼻梁、脸颊和下唇/下巴区域与患者面部接合。但是,其他的衬垫接口也是可以的,例如鼻部衬垫接口。
衬垫1060构造得更具顺从性或者柔性(例如尤其是在鼻梁区域)以适应由于不具有前额支架使得一些稳定性损失所导致的更多移动。
衬垫1060是由软且柔性的生物相容性材料制成的,例如,诸如硅树脂。在图示的实施例中,衬垫1060包括双壁结构,其中衬垫包括如图8所示的在隔膜1064下面的底衬垫或者支撑壁1062。
隔膜1064通常比底衬垫1062软并且没有底衬垫1062硬,并在使用中对于患者面部提供密封。针对前额支架的更差的面罩稳定性,隔膜可以是相对薄的以允许对患者面部的更宽的适配范围和更好的符合度。底衬垫构造为当面罩系统使用头带被连接和绷紧时大体上支撑隔膜并防止隔膜的皱缩。
隔膜1064是大体凹形的并且朝着呼吸腔室向内弯曲。底衬垫1062也可以向内弯曲但是通常比隔膜更短、更厚并且更具刚性。
在一实施例中,衬垫1062在患者鼻梁和/或下巴的区域在高度上更短或者完全没有,衬垫1062从顶端到底部的高度可以在大约0mm到30mm之间。在任何给出的横截面上,隔膜通常比底衬垫1062长,隔膜可以在大约1mm到40mm之间。例如,图8B图示了穿过衬垫的鼻梁和下巴区域的剖视图以图示出隔膜1064,且在这些区域不具有底衬垫。
在一实施例中,底衬垫1062可以仅设置在面罩系统的选定区域中,例如在面罩系统被推离患者面部之处。可以优选地避开患者面部上的某些预定区域,这些区域用以通过头带的绷紧来施加压力。在图示的实施例中,患者的鼻梁和下巴区域不包括底衬垫1062。在这些区域,底衬垫仅沿衬垫的横向侧设置(例如见于图7),衬垫的横向侧压向脸颊以在使用中更均匀地分布由面罩系统施加的力矢量。在一实施例中,沿着脸颊区域,底衬垫可以相对硬,因为这些接触点充当锚定点,即使面罩系统支持在适当位置上以提供有效的密封。
通过减少施加在敏感区或经受相对更高接触压力的患者面部的突起区域上的力或压力,这种避开患者的鼻梁和下巴的结构可以增加面罩系统对患者的舒适性。此外,这种配置避免了当调整面罩系统时衬垫挤压患者的鼻梁。此外,由于不存在底衬垫,这个实施例的衬垫在鼻梁和下巴的区域中可以明显地更软。
在一实施例中,底衬垫可以包括变化的高度、刚度和/或厚度,以在需要更轻支撑的面部的上述预定区域中产生变化的柔软度。
在图示的实施例中,衬垫可以构造为在患者鼻梁和眼窝较下部密封,使得衬垫更不突显。
在一实施例中,衬垫通常是磨砂的,除了在患者接触表面处是磨光的。在一实施例中,衬垫的磨砂可以减少面部和隔膜之间和/或隔膜和底衬垫之间的约束。磨砂使得隔膜和底衬垫的表面可以相对于彼此相应的表面滑动,而不存在未磨砂硅树脂的相同约束。这个特征也可以防止或者限制隔膜粘附到底衬垫元件上,也可以大体上改善衬垫的整体舒适性和密封特性。此外,衬垫的磨砂也更容易制造,并且可引起制造成本的降低。衬垫可以由磨砂硅树脂或者其他适当的材料制成。
3.2鼻梁下部衬垫(cushionloweronnasalbridge)
图31-1至图31-5图示了根据本发明实施例的衬垫44(例如用硅树脂制成)的各种视图。如图所示的,衬垫44包括设置至框架的基壁44(1);远离基壁44(1)延伸的底衬垫层(UCL)44(2);和设置为基本覆盖UCL44(2)并提供密封构造的隔膜44(3)。在图示的实施例中,衬垫44构造为位于鼻梁下部以在使用中减少面罩突显性和改善“视线”。
而且,如在图31-3至图31-5中最好地示出的,在鼻梁区域中的UCL44(2)设计被构造为在使用中提供横跨鼻梁的改善的稳定性。如图31-1和图31-3所示的,在下唇/下巴区域没有设置UCL。但是,其他的UCL配置是可以的,例如围绕整个周边的UCL。
在图31-3至图31-5中示出的衬垫的实施例中,D1可以是大约15-20mm,例如18.2mm,D2可以是大约53-59mm,例如55.8mm,D3可以是大约88-93mm,例如90mm,D4可以是大约78-83mm,例如81.1,D5可以是大约58-63mm,例如60mm,D6可以是大约95-100mm,例如98.1mm,D7可以是大约57-62mm,例如59.7mm,D8可以是大约77-82mm,例如79mm,D9可以是大约88-93mm,例如90.7mm,D10可以是大约30-35mm,例如33.1mm,D11可以是大约14-19mm,例如16.4mm,D12可以是大约8-13mm,例如9.6mm,D13可以是大约0.3-0.5mm,例如0.35mm,D14可以是大约0.4-0.6mm,例如0.5mm,D15可以是大约0.3-0.5mm,例如0.4mm。虽然标出了具体的尺寸和范围,应当理解的是这些尺寸和范围仅仅是示例性的,取决于应用,其他的尺寸和范围也是可以的。例如,取决于应用,示例性的尺寸可以变动10-20%或者更多或者更少。
3.3鼻梁上部衬垫(cushionhigheronnasalbridge)
图35-1至图35-2图示了全面部衬垫244,其适于大体上沿着患者面部的鼻梁、脸颊和下唇/下巴区域接合患者面部。在这个实施例中,出于密封和舒适性,衬垫244构造为使得其位于鼻梁上部(例如相对于上文描述的衬垫44)。对于人体测量学而言衬垫244也是更优的,即衬垫会适配更多的人。
在一实施例中,衬垫244可以包括如下文所述的手风琴式部分(例如在鼻梁区域中)以在使用中提高衬垫的柔性。
3.4手风琴式部分
如在图30和图33中最好的示出的,手风琴式部分50可以设置在衬垫和/或框架的鼻梁区域中。如图所示的,手风琴式部分50包括具有一个或者多个折叠52的波形结构(bellowsstructure),折叠52提供了更高程度的柔性或者增加的移动。也即是说,手风琴式部分50为作为患者面部在使用中更敏感区域的衬垫/框架的鼻梁区域提供了更高水平的顺应性(adaptability)或柔性。而且,手风琴式部分50在未折衷密封性的情况下提供了增加的移动。
图32-1至图32-3图示了根据本发明一实施例的具有一个或者多个折叠52的手风琴式部分50(从衬垫/框架的其余部分隔离出来)的各种视图。如图32-3最好地示出的,折叠相对于彼此可以具有不同的长度、深度和/或轮廓以优化手风琴样效果(concertinaeffect),例如在不折衷密封性的情况下提供足够程度的移动。例如,如图32-3所示的,每个折叠52包括第一侧壁52(1)和使相邻的侧壁52(1)相互连接的第二侧壁52(2)。
在图示的实施例中,第一侧壁52(1)和/或第二侧壁52(2)可以远离患者面部逐渐变得更长。例如,邻近于患者面部的第一侧壁52(1)和/或第二侧壁52(2),或者侧壁52(1)和52(2)的组合,可以具有长于而且在一些情形下显著地长于邻近侧壁52(1)和/或52(2)的长度(例如一个侧壁比另一侧壁至少长25%,直至长达另一侧壁的5倍,例如1倍、2倍、3倍或4倍)。
折叠可以被构造并配置为提供预定顺序的移动或者褶皱,例如折叠被构造为以连续或者渐进的方式褶皱,其中一个折叠在相邻折叠皱缩之前皱缩。例如,当施加力时,最靠近患者面部的折叠可以在最远离患者面部的折叠之前褶皱或者皱缩。而且,折叠也可以被构造和配置为提供不同程度的褶皱或者皱缩,例如折叠可以比其他折叠或者皱缩得更多。
在图32-1至图32-3所示的手风琴式部分的实施例中,D1可以是大约50-60mm,例如55.7mm,D2可以是大约5-15mm,例如9.7mm,D3可以是大约0.3-0.5mm,例如0.4mm。虽然标出了具体的尺寸和范围,应当理解的是这些尺寸和范围仅仅是示例性的,取决于应用,其他的尺寸和范围也是可以的。例如,取决于应用,示例性的尺寸可以变动10-20%或者更多或者更少。
应当理解的是,例如取决于患者舒适度,手风琴式部分50可以设置在衬垫和/或框架的其他区域中。例如,手风琴式部分50可以绕着衬垫和/或框架的整个周边设置,或者可以设置在衬垫和/或框架的选定区域中。
而且,例如取决于患者舒适度,手风琴式部分50的柔性可以变化,而且可以在衬垫和/或框架的不同区域中变化。例如,衬垫和/或框架可以包括在鼻梁区域中的具有相对高度柔性的手风琴式部分和在下唇/下巴区域中的具有相对低度柔性的手风琴式部分。可以通过改变折叠52的数量(例如1-5个折叠)、折叠52的壁长、壁厚、折叠52的深度等来改变手风琴式部分50的柔性。
如上文指出的,衬垫和框架可以是由具有不同材料/刚度的两个部分共模制而成的,或者由相同的材料整体形成。在这两种实施例中,手风琴式部分可以设置在框架和/或衬垫中。
在图27-30中,衬垫44和框架40是由两部件共模制而成的,手风琴式部分50设置在框架40中。框架40和衬垫44具有不同的刚度从而优化每个部件的功能。例如,一个部件(即衬垫44)可以由相对软且柔顺的材料制成以优化密封效果,而另一部件(即框架40)可以由更刚性的材料制成以为衬垫提供足够的支撑同时允许足够程度的移动以优化手风琴样效果。尽管框架比衬垫更具刚性,但是框架也可以由柔性的材料制成以允许手风琴样效果。
在图33中,框架40和衬垫44整体形成为一单件,手风琴式部分50设置在框架40中。可以选择性地改进材料特性和/或尺寸以优化密封和手风琴样效果。
对于图27-30和图33的实施例,应当理解的是,可选地,手风琴式部分可以设置在衬垫44中或者设置在框架40和衬垫44二者中。例如,图34图示了手风琴式部分50在鼻梁区域中与衬垫44整体形成。
4、肘管
如图3所示,肘管1070(例如由相对硬质的材料制成,诸如聚碳酸酯或者聚丙烯)包括第一端部1074(1)和第二端部1074(2)。第一端部1074(1)提供了构造为对接框架1040或反之连到框架1040上的对接结构。第二端部1074(2)适于连接到空气输送管。
4.1肘管与框架的连接
框架1040构造为将肘管1070相对于患者面部保持在工作位置。即,框架充当肘管的托架或者支承面。框架和肘管可以以摩擦配合件、搭扣配合件、机械互锁件或者其他适当的连接机构来连接。但是,将肘管连到框架的其他适当配置也是可以的。
在图示的实施例中,肘管1070包括一系列柄脚(tang)1075,柄脚1075适于可松开地接合在框架1040的开口1032内,例如通过搭扣配合。柄脚1075使肘管支持在适当的位置上(例如,优选相对气密的连接)并允许肘管相对于框架转动或者旋转。
即,肘管可转动地连到框架上,以使得在使用中肘管可以相对于框架转动,例如360°转动。这种配置使得肘管在使用中可以例如取决于患者偏好而呈现不同的方位。例如,肘管可以呈现第一方位以使得肘管从面罩大体向下延伸从而在使用中在患者头部下方引导空气输送管。可选地,肘管可以旋转并呈现第二方位以使得肘管从面罩大体向上延伸从而在使用中在患者头部上方引导空气输送管。在一实施例中,框架和肘管可以用不相同的材料制造,以防止或者至少减少使用中元件之间的滑音。
肘管的第二端部可以设置在适于连接至空气输送管的旋转接头上。例如,图27-30图示了设置在肘管70的第二端部74(2)的旋转接头80。在图示的实施例中,旋转接头80设置至使肘管与空气输送管相互连接的短管82(例如可延长且可收回的管)。在一实施例中,旋转接头80可以与短管82整体形成为一单件。
4.2AAV
肘管1070包括:接收反窒息阀(AAV)的狭槽1081;由AAV的挡板部分(flapportion)选择性地关闭(取决于压缩气体的存在)的端口1079;和用于例如以搭扣配合与AAV相连的结构。
图27-30图示了示例性的AAV85,其包括选择性地关闭肘管70中的端口79的挡板部分86。在这个实施例中,用于将AAV85连到肘管70上的夹子部分88设置在挡板部分86上。在图示的实施例中,挡板部分86和夹子部分88是彼此共模制而成的以形成为单件式的整体元件。但是,挡板部分86和夹子部分88可以以其他适当的方式、例如机械互锁稳固到彼此上。
在一实施例中,挡板部分86可以由相对软的弹性材料制成(例如硅树脂),而夹子部分88可以由更具刚性的材料(例如刚性塑料)制成以对接肘管70。
AAV85的夹子部分88包括例如通过搭扣配合与肘管70可拆卸地互锁的构造。例如,夹子部分88可以包括构造为与设置于肘管上的相应凹槽/突起互锁的突出部(tab)。
图35-1和图35-2图示了肘管270,其包括由AAV285的挡板部分286选择性地关闭(取决于压缩气体的存在)的端口279。而且,图37-1至图37-3图示了肘管370,其包括端口379和固定AAV的狭槽381。
在申请号为PCT/AU2006/000031的PCT申请中公开了AAV的可选实施例,其全文通过引用合并于此。
4.3大直径端部
如图27-30所示,肘管70的第一端部74(1)可以提供相对大的直径,这种相对大直径允许有更清晰/更流畅的线条的可能性,从而对于整个面罩的美感和降低的突显性起到贡献。此外,相对大直径的肘管为患者鼻部提供了突入肘管腔体的可能性,从而允许面罩离患者面部更近(即降低的突显性),由于面罩重心更靠近患者面部使得力矩更小,和/或改善视线。
5、模块化设计
面罩系统提供了模块化设计,这允许不同类型和/或尺寸的框架(也称作框架模块)、护罩(也称作护罩模块)、衬垫(也称作衬垫模块)和/或肘管(也称作肘管模块)互换或混合以及互相匹配,从而为患者提供更加定制的面罩系统。此外,这种设计使得例如治疗需要改变、破损或者损坏时允许容易地更换选择的模块。
在一实施例中,面罩系统可以设置有许多不同的衬垫,例如每个具有不同类型和/或尺寸的衬垫(例如取决于患者偏好和/或适配性)。例如,每个衬垫的非面部接触侧可以包括用于对接框架的共同或者通用结构,而衬垫的面部接触侧可以包括不同类型和/或尺寸。这提供了允许框架选择性地(例如并且可拆卸地)联结到多个衬垫之一的模块化配置。例如,不同的衬垫可以包括不同尺寸的衬垫(例如小号、中号和大号),并且可以包括不同的衬垫构造。
在一实施例中,面罩系统可以设置有不同的护罩,例如每个护罩具有不同的类型和/或尺寸(例如具有不同配置/类型的头带连接器的护罩;具有前额支架、不同头带矢量等的护罩)。
在一实施例中,面罩系统可以设置有不同的框架,例如每个框架具有不同的类型和/或尺寸(例如具有不同通气口装置的框架;小号、中号和大号框架等)。
在一实施例中,面罩系统可以设置有许多不同的肘管,例如每个具有通气口装置、AAV(在口鼻面罩的情形中)和/或不同类型和/或尺寸的肘管。在图27-30图示的实施例中,通气口装置76和AAV85构造为可拆卸地连到肘管70上。这提供了允许肘管可选择地并且可拆卸地联结到多个通气口装置和/或AAV之一的模块化配置。这也允许容易地更换通气口装置和AAV,例如若损坏时。
5.1护罩至框架的连接
护罩安装在框架的外表面上,例如优选地通过在框架上的紧密且符合的配合部。
5.1.1上固定机构
在图1-5图示的实施例中,护罩1020通过位于框架和护罩的顶端的上固定机构或对接结构1048而连接至框架1040。
如图2至图5所示,上固定机构1048呈两个锥形锁紧件(taperlock)的形式,该锥形锁紧件构造为将护罩1020稳固在框架1040上并防止尤其是由于头带力导致的无意拆卸。在这个实施例中,框架的相对侧均包括适于接收护罩1020内侧(underside)的相应柄脚突起(沿着其长度逐渐变细)的凹狭槽1055。锥形的突起例如以摩擦配合接合在相应的凹狭槽内。
图10至图19-4示出了面罩系统的另一个实施例,其更加清楚地图示了锥形锁的实施例。图10至图17示出了面罩系统1110的框架1140、护罩1120和肘管1170的各种视图。
如在图11至图13所最好地示出的,框架1140的顶端的相对侧均包括提供第一凹狭槽1151(1)的平台1154。此外,框架1140的外表面与平台1154之间的空间限定了第二凹狭槽1151(2)。如在图17中最好地示出的,护罩1120的顶端的相对侧均包括在护罩1120的内侧的柄脚突起1156。柄脚突起1156包括第一柄脚1156(1)和大体上横向于第一柄脚1156(1)延伸的第二柄脚1156(2)。如图18-1和图18-2所示,每个柄脚可以沿着其长度逐渐变细,即朝向其自由端更薄。
图18-1和图18-2和图19-1至图19-4以顺次关系图示了将护罩1120连到框架1140上。如图所示,每个柄脚突起1156的柄脚1156(1)、1156(2)构造为例如通过摩擦配合接合相应狭槽1155(1)和1155(2)。如在图19-1至19-4中最好地示出的,每个狭槽1155(2)包括沿着它们的长度弯曲(即在垂直和水平方向延伸)的引入件或引导件1157以便引导柄脚1156(2)进入狭槽1155(2)和协助装配。图18-2和图19-4示出了柄脚1156(1)、1156(2)充分插入相应狭槽1155(1)、1155(2)。
在一可选实施例中,如图20所示,上固定机构可以包括夹子型配置。如图所示,框架1240的顶端的相对侧均设置了台肩1255(1)和锥形突起1255(2)。护罩1220的顶端的相对侧均包括在护罩1220的内侧的第一柄脚1256(1)和第二柄脚1256(2)。在使用中,每个第一柄脚1256(1)与相应的台肩1255(1)接合,第二柄脚1256(2)接合锥形突起1255(2)或者夹到锥形突起1255(2)上,例如通过搭扣配合。
5.1.2下固定机构
在一实施例中,护罩也可以通过位于框架和护罩的底端上的下固定机构而连接到框架上。例如,固定机构可以设置于护罩的开口上,其中该开口被构造为与框架的开口互锁或反之与框架的开口相接合。
例如,如图14、15、17和21所示的,护罩1120的开口1132可以包括适于通过搭扣配合接合围绕框架开口1146的凸颈圈1149的结构。如图所示,护罩1120包括从开口1132延伸的搭扣指状件(snapfinger)1145(1)(例如三个搭扣指状件)和夹合突出部1145(2)(例如三个夹合突出部)。可选地,搭扣指状件和夹合突出部绕着开口间隔设置。
在使用中,搭扣指状件1145(1)弹性地偏斜(例如0.5mm偏斜)并且接合设置于凸颈圈1149上的相应的部分环形突起1149(1)(例如见于图22和图23),从而提供将护罩1120(例如,以容许应力)初始保持至框架1140上,例如以便于组装和拆卸。此外,随着搭扣指状件1145(1)与相应的突起1149(1)接合,夹合突出部1145(2)被容纳在设置于凸颈圈1149的一端上的相应凹槽1149(2)中(例如见于图22和图23)。当肘管1170与框架1140接合时(见于图23),肘管1170上的环形突起1171位于夹合突出部1145(2)的一相对侧,因此夹合突出部1145(2)被夹在凸颈圈1149和肘管1170之间。因此,在使用中,夹合突出部利用肘管保持力将护罩固定在框架上。肘管1170具有适于在框架1140的边缘下方延伸以将肘管固定到框架上的远侧台肩1173。搭扣指状件1145(1)允许护罩独立于肘管连接到框架上。
在一可选实施例中,如图24所示,护罩的下部分可以构造为夹到凸颈圈下方的一单点上。如图所示,护罩1320的下端包括例如通过搭扣配合接合到或者夹到在框架1340的凸颈圈1349下方与凸颈圈1349隔开的突起1349(1)上的搭扣指状件1345。在这个实施例中,突起1349从封住辅助端口的盖子延伸出。这种配置可以便于将凸颈圈模制到框架上,例如凸颈圈的均匀厚度防止了模制变形,此外,从凸颈圈上移除突起1149(1)/凹槽1449(2)可以减少泄露的风险。
5.1.3指状抓握部
在一实施例中,框架1040的外表面可以包括定位成暴露在护罩1020之下的指状抓握部或者凹入部分1097。指状抓握部适于允许患者改善抓住框架和/或护罩的能力,这在当将护罩从框架上分离时尤其有用。
5.1.4可选的对接结构
在一可选实施例中,如图27-30所示,护罩20包括开口构造,该开口构造提供了构造为固定框架40和肘管70的环形或者部分环形固定部分22。如图所示,环形固定部分22包括沿着内边缘的对接结构23,对接结构23适于对接沿着框架40外周边的对接结构48或者反之可拆卸地连接到对接结构48(例如见于图28)。在图示的实施例中,对接结构23呈对置的凸缘23(1)的形式,对置的凸缘23(1)适于与设置在框架40的相对两侧的相应锁止构造48(1)互锁。但是,将框架40连到护罩20上的其他适当配置也是可以的,例如摩擦配合件、搭扣配合件、机械互锁件或者其他适当的连接机构。
例如,框架40可以以允许框架40相对于护罩20锁止在不同的角位置的方式,例如可枢转地安装的方式,联结到护罩20上。
5.1.5可选的上头带连接器
图40-1至图40-7图示了根据本发明另一个实施例的框架和夹式上头带连接器或者硬化件。
框架442包括适于接合框架护罩和/或肘管的开口449。围绕并位于开口449下方的是用于气体冲洗的U形狭槽402和在其每侧的辅助端口443。
在这个实施例中,框架442的每个上侧均包括固定元件433,框架442的上中部包括固定槽435,固定槽435构造并配置为固定上头带连接器或者硬化件424。
如图40-6和图40-7最好地示出的,上头带连接器424包括由一对缆线元件428联结的一对伸长臂或硬化件426。每个硬化件426包括在其自由端处的适于在使用中接收相应头带绑带的狭槽427。
在使用中,上头带连接器424适于夹到框架442上(例如见于图40-1和图40-2)。具体地,缆线元件428的中部被接收在框架442的相应槽435中,缆线元件428的端部延伸穿过相应的固定元件433,其中硬化件426提供了与相应固定元件433互锁的台肩。图40-4和图40-5示出了固定元件433的上部分,以图示出适于接收相应缆线的槽433(1)。如图所示,槽433(1)的一端包括锥形侧壁433(2)并朝向后侧433(3)降低以将硬化件426定位为与固定元件433互锁接合。
图41-1至图41-12图示了根据本发明另一个实施例的框架的上部分和夹式上头带连接器或者硬化件。
如图所示,框架542的上部分包括在其每侧的固定元件533和沿着其中部的固定槽535,固定元件533和固定槽535构造和配置为固定上头带连接器或者硬化件524。
如图41-5和图41-12最好地示出的,上头带连接器524包括由连接部分528联结的一对伸长臂或者硬化件526。每个硬化件526包括在其自由端处的适于在使用中接收相应头带绑带的狭槽427。此外,上头带连接器524包括在连接部分528每侧的夹子构造525。
在使用中,上头带连接器524适于夹到框架542上(例如见于图41-1和图41-2)。具体地,连接部分528被接收在框架542的槽535中,并且夹子构造525与相应的固定元件533可释放地互锁。如图41-3和图41-4最好地示出的,每个固定元件533提供了横杆,每个夹子构造525提供了V形结构,该V形结构适于有弹性地偏转穿过横杆并提供与横杆可释放地互锁的台肩。
图42-1至图42-7图示了上头带连接器接合框架的可选实施例。如图所示的,每个固定部分533提供了开口的(open-ended)横杆,每个夹子构造525提供了伸长臂。在这个实施例中,横杆构造为有弹性地偏转,以允许夹子构造525穿过横杆延伸并且例如通过摩擦配合可释放地与横杆接合。此外,图42-1至图42-7中的上头带连接器524包括适于与设置在框架542上的突出部549互锁的c形夹子构造529(见于图42-1和图42-2)。
5.1.6索环连接
图44和图45图示了其中护罩经由索环(grommet)连到框架上的可选面罩配置。
例如,如图44所示,框架740包括索环745(例如以橡胶制成),护罩720包括适于接收索环745以将护罩720稳固到框架740上的开口725。如图所示的,护罩720包括上伸长臂724和下伸长臂726,每个臂都具有适于在使用中接收相应头带绑带的在其自由端处的狭槽727。
图45图示了包括单臂的可选护罩820,单臂具有适于在使用中接收相应头带绑带的在其每端的狭槽827。此外,护罩820设置了适于接收框架740的索环745的内长槽825。与提供单个固定位置的护罩720相反,长槽825允许索环745固牢在沿长槽825长度的多个位置之一上。在一实施例中,护罩820可以相对于索环745是可滑动的以允许相对于框架740的无限量的位置。
在每个实施例中,索环745(例如以橡胶制成)将护罩固牢在适当位置上,但是索环745的固有柔性提供了柔性连接以将护罩与框架分离并且允许这两个元件之间一定范围的移动,例如类似球形接头或者万向接头。这种配置帮助将面罩安装和密封到患者面部上。也即是说,柔性连接允许面罩相对于患者面部选择性地调节和/或自适配。
5.2衬垫与框架的连接
在图1-8中,衬垫1060的非面部接触侧以舌和槽的关系与框架1040连接。衬垫1060的舌1066(见于图1C、图1D和图8)插入沿着框架1040的周边设置的槽1041(见于图1C和图1D)内。舌和槽的关系也可以包括适于与框架槽内的底切卷边(undercutbead)1042(见于图1C和图1D)互锁的衬垫上的锁止唇缘或者密封唇缘1068(见于图1C、图1D和图8),从而固牢地将衬垫固定到框架上。
在图示的实施例中,衬垫1060还包括一个或者多个绕其周缘设置的定位特征部分,以协助衬垫与框架1040适当地对齐。如图7所示,衬垫1060包括适于接合框架中的互补特征部分的凹口和/或突起(例如两个凹口1067和一个突起1069),例如互锁关系。
5.2.1共模制框架和衬垫
在一实施例中,如图27-30所示,框架40和衬垫44可以相互共模制而成以形成单件式的整体元件。例如,框架40可以由适于对接护罩20的第一材料模制而成,衬垫44可以由适于对接患者面部的第二材料共模制到框架40上。
在这种实施例中,衬垫44可以用相对软的弹性材料制成(例如硅树脂)以用于密封,而框架40可以用比对接框架的衬垫44更具刚性的材料(例如聚碳酸酯、聚丙烯)制成。
将框架40共模制到衬垫44提供了化学结合而不需要形成机械互锁。结果,连接部不包括裂缝,而是包括气密性密封和清洁的接合面(interface)。而且,由于模制材料是足够柔性的以填充框架40和衬垫44之间的接合面处的任何间隙,这种共模连接放宽了容许偏差。而且,共模制框架/衬垫提供了减少的部件总数(减少了成本),并且利于与护罩20的组装/拆卸。
在一可选实施例中,如图33所示,框架40和衬垫44可以例如由硅树脂材料整体形成为一单件。即,框架40可以具有与上述相同的形状和构造,但是由例如硅树脂的相同材料整体模制成。
在一实施例中,整体形成的框架40/衬垫44可以共模制到例如由聚碳酸酯或者聚丙烯制成的护罩20上。例如,护罩20可以由相对刚性的材料(例如聚碳酸酯或者聚丙烯)制成,框架40/衬垫44可以共模制到由相对软且弹性的材料(例如硅树脂)制成的护罩20上。
5.3通气口装置
在图1、图1B、图1C、图1D和图2-5中,通气口装置1076设置在框架上,并包括在框架的外表面上以一角度(例如45°)定位的多个孔1077(例如5-100个孔,例如20-50个孔,或者大约35个孔),以保证引导呼出空气远离患者,优选地当患者睡眠时远离他们的床伴。如在图1C和图1D中所示的,每个孔1077可以包括沿着其长度的轮廓或者锥度。但是,应当理解的是,通气口装置可以包括其他适当的配置,例如不同数量的孔、孔配置、在框架上的定位、通气口提供了与护罩的互锁构造的一部分等。
图35-1图示了设置在框架240上的用于气体冲洗的通气口装置276。在图示的实施例中,通气口装置276是通气口插件的形式(例如弹性通气口插件),该通气口插件适于可移除地支撑在框架240中的排出口内。通气口插件可以类似于美国专利6,561,190,6,561,191和7,207,335中描述的通气口插件,其全文通过引用合并于此。但是,应当理解的是,通气口装置可以具有其他适当的形式(例如在主体中的通气孔等)。
图37-3、图39-2和图39-4图示了包括u形狭槽302的框架340,狭槽302接收用于气体冲洗的u形插塞式通气口305。如图所示的,插塞式通气口305围绕用于肘管370的框架340的开口并在该开口之下。插塞式通气口305包括在其每侧的多个通道或者槽307。在使用中,带槽的插塞式通气口305与狭槽320形成了密封,因此呼出的空气可以在狭槽壁和插塞式通气口305上的槽307之间排出。在一实施例中,端口帽347可以结合或者合并入插塞式通气口305中(例如整体地形成为一单件)。2008年8月22日提交的12/230,120号美国专利申请提供了这种插塞式通气口装置的详细细节,其全文通过引用合并于此。图39-2至图39-6示出了移除了带槽的插塞式通气口305的框架340,以更加清楚地示出在其每侧的u形狭槽302和辅助端口343。
而且,应当理解的是通气口装置可以设置在肘管上。例如,如图27-30所示的,通气口装置76是适于可移除地支撑在肘管70中的排出口内的通气口插件的形式。在一实施例中,通气口装置76包括:适于支撑在排出口内的基部;设置在该基部上并构造为扩散通气流的一个或者多个格栅元件或者媒介(例如过滤片、隔膜或者其他多孔材料);和将格栅元件/媒介保持在该基部内的盖子。在图27-30中只有通气口装置76的盖77是可见的。
2008年8月22日提交的12/230,120号美国专利申请提供了这种通气口装置的示意性实施例,其全文通过引用合并于此。
但是,应当理解的是通气口装置可以包括其他适当的配置,例如具有一个或者多个通气孔的通气口插件。
而且,肘管也可以提供通气口插件的可选通气口装置。例如,如图30中的虚线所示的,肘管70的第一端部74(1)(例如沿着对接结构75)可以包括一个或者多个用于气体冲洗的通气孔276。一个或者多个孔276可以设置在肘管的软部(例如如下文所述的硅树脂密封)和/或硬部(例如聚碳酸酯、聚丙烯)。孔276可以绕着第一端部74(1)的整个周边延伸或者可以沿着第一端部74(1)的一个或者多个部分延伸。应当注意的是,沿着肘管的整个周边设置通气孔可以协助在使用中分散通气流。但是,沿着肘管的第一端部74(1)和/或其他部分的其他适当的孔配置、孔数量和/或孔形状也是可以的。
5.4端口
在图1-5中,框架1040的底部包括两个端口1043,端口1043定位成使得在使用中氧气或者其他可呼吸气体可以输送到靠近患者鼻孔或者可以连接压力监控设备。端口1043也可以用来连接例如压力或流量传感器等的额外医疗设备。端口可以由端口帽选择性地关闭或者密封。
在一可选实施例中,如图25和图26所示,例如,除了端口1043之外或者作为对端口1043的替代,框架1040可以包括侧端口1043.1。
图35-1和图35-2示出了框架240,其包括在框架的上部分上的例如用于补充氧气、测量设备等的辅助端口或者插口243。
在图37-1至图37-3和图39-1至图39-6中,框架340包括例如用于补充氧气、测量设备等的在其每侧的辅助端口或者插口343。设置端口帽347以密封相应的端口343。
6、接合面密封件
在一实施例中,在肘管和护罩之间的接合面处、框架和护罩之间的接合面处、和/或肘管和框架之间的接合面处可以设置密封件。例如,密封件(例如弹性的环形密封件)可以独立于模块形成并连在接合面处(例如夹在模块之间、粘着等)。可选地,密封件可以与一个或者多个模块共模制而成。在一实施例中,硅树脂唇状密封件可以设置在框架上以相对于肘管密封,从而减少泄露。
在另一个实施例中,如图27-30所示,肘管70的对接结构75可以由构造为在肘管70和护罩20之间的接合面处提供密封的相对软的密封材料(例如,硅树脂,其可以共模制到肘管的较硬材料上)制成。而且,相对软的对接结构75(例如硅树脂)提供了“软”连接至相对硬的护罩20(例如聚碳酸酯、聚丙烯),这可以允许干涉型配合。如上文指出的,可以在较软的对接结构和/或较硬的肘管上设置一个或者多个通气孔。
虽然已结合当前认为是最实用的和最优选的实施例描述了本发明,但应当理解的是本发明不局限于所公开的实施例,相反的,本发明意于涵盖包括在本发明的精神和范围内的各种修改和等同的设置。而且,上述不同的实施例也可以与其它实施例结合实施,例如,将一个实施例的技术方案可以与另一个实施例的技术方案结合来实现再一个实施例。此外,任何已给出的组件的各个独立特征或元件可以组成另外的实施例。再者,一个或多个实施例中的任何已给出组件中的每个单独元件、任何已给出组件中的每个单独元件的一个或多个部分、以及元件的各种组合可包括一个或多个装饰性设计特征。另外,虽然本发明对患有OSA的病人有特殊的应用,但应当理解的是患有其它疾病(例如,充血心力衰竭、糖尿病、病态肥胖症、中风和腹腔镜手术等)的病人可以从上述技术获利。此外,上述技术适用于病人和非医疗应用中的相似的非病人。
Claims (87)
1.一种面罩系统,包括:
框架,其限定呼吸腔室;
衬垫,其设置于所述框架上并且适于与患者的面部形成密封;以及
护罩,其设置于所述框架上,
其中所述护罩与所述框架是彼此共模制而成的,所述框架是由相对软且弹性的第一材料制成,而所述护罩是由比所述框架更具刚性的第二材料制成,
并且所述框架的至少一部分包括具有多个折叠的手风琴式部分,每个折叠具有侧壁,所述折叠的侧壁远离患者面部逐渐变得更长。
2.根据权利要求1所述的面罩系统,其中所述框架是由硅树脂制成的。
3.根据权利要求1-2中任一项所述的面罩系统,其中所述护罩是由聚碳酸酯制成的。
4.根据权利要求1-3中任一项所述的面罩系统,其中所述手风琴式部分设置于框架的鼻梁区域。
5.根据权利要求1-4中任一项所述的面罩系统,其中所述衬垫是全面部衬垫。
6.根据权利要求1-5中任一项所述的面罩系统,其中所述手风琴式部分的柔性是可变的。
7.根据权利要求6所述的面罩系统,其中所述手风琴式部分的柔性能够通过改变以下中的至少一个来改变:折叠的数量、每个折叠的壁厚和每个折叠的深度。
8.一种衬垫模块,包括:
框架,其限定呼吸腔室;以及
衬垫,其适于与患者的面部形成密封,
其中所述框架与所述衬垫是彼此共模制而成的,所述衬垫是由相对软且弹性的第一材料制成,而所述框架是由比所述衬垫更具刚性的第二材料制成,并且所述框架的至少一部分包括手风琴式部分。
9.根据权利要求8所述的衬垫模块,其中所述手风琴式部分包括具有一个或者多个折叠的波形结构。
10.根据权利要求9所述的衬垫模块,其中所述手风琴式部分的柔性是可变的。
11.根据权利要求10所述的衬垫模块,其中所述手风琴式部分的柔性能够通过改变以下中的至少一个来改变:折叠的数量、每个折叠的壁厚和每个折叠的深度。
12.根据权利要求8-11中任一项所述的衬垫模块,其中所述手风琴式部分设置于框架的鼻梁区域。
13.根据权利要求8-12中任一项所述的衬垫模块,其中所述衬垫是全面部衬垫。
14.一种面罩系统,包括:
护罩;以及
设置在所述护罩上的根据权利要求8-13中任一项所述的衬垫模块。
15.根据权利要求14所述的面罩系统,其中所述护罩包括适于可拆卸地连到头带的相应头带绑带上的头带连接器。
16.根据权利要求15所述的面罩系统,其中所述护罩包括在所述护罩每侧的上头带连接器和下头带连接器。
17.根据权利要求16所述的面罩系统,其中每个上头带连接器包括伸长臂和在所述臂的自由端处的适于在使用中接收相应的头带绑带的狭槽。
18.根据权利要求16-17中任一项所述的面罩系统,其中每个下头带连接器包括适于与和相应头带绑带联接的头带夹子可拆卸地互锁的夹子插口。
19.根据权利要求14-18中任一项所述的面罩系统,其中所述护罩包括提供了构造为固定所述框架的环形固定部分的开口构造。
20.根据权利要求14-19中任一项所述的面罩系统,进一步包括适于连接到将可呼吸气体输送给患者的空气输送管的肘管。
21.根据权利要求20所述的面罩系统,其中所述肘管设置于所述框架上。
22.根据权利要求20-21中任一项所述的面罩系统,其中所述肘管包括用于气体冲洗的通气口装置,所述通气口装置是适于能够可拆卸地连到所述肘管上的通气口插件的形式。
23.根据权利要求20-22中任一项所述的面罩系统,其中所述肘管包括反窒息阀,所述反窒息阀是适于能够可拆卸地连到所述肘管上的插件的形式。
24.根据权利要求23所述的面罩系统,其中所述反窒息阀包括适于选择性地关闭设置在所述肘管中的端口的挡板部分和适于可拆卸地连到所述肘管上的夹子部分。
25.根据权利要求24所述的面罩系统,其中所述挡板部分和所述夹子部分是彼此共模制而成的。
26.根据权利要求20-25中任一项所述的面罩系统,其中所述肘管包括至少第一和第二肘管,所述至少第一和第二肘管在至少一个方面彼此不同。
27.根据权利要求14-26中任一项所述的面罩系统,其中所述框架包括适于设置在所述护罩上的至少第一和第二框架,所述至少第一和第二框架在至少一个方面彼此不同。
28.一种用于构造衬垫模块的方法,包括:
用相对软且弹性的第一材料模制所述衬垫模块的第一部件;
用比所述第一材料更具刚性的第二材料将所述衬垫模块的第二部件共模制在所述第一部件上;以及
将所述第二部件的至少一部分模制为包括手风琴式部分。
29.一种用于面罩系统的护罩,包括:
固定部分,其构造为固定框架;
一对上头带连接器,各自均包括伸长臂和在所述臂的自由端处的适于接收头带绑带的狭槽;以及
一对下头带连接器,各自均适于连到头带绑带上,
其中所述固定部分、所述上头带连接器和所述下头带连接器整体形成为单件结构。
30.根据权利要求29所述的护罩,其中每个下头带连接器包括短缩臂和在所述短缩臂的自由端处的适于接收所述头带绑带的狭槽。
31.根据权利要求29所述的护罩,其中每个下头带连接器包括适于与和头带绑带联接的头带夹子可拆卸地互锁的夹子插口。
32.根据权利要求29所述的护罩,其中所述伸长臂被适当地定轮廓为:在使用中在患者耳朵上方延伸,并将头带绑带固定在患者耳朵上方与患者耳朵呈隔开关系。
33.根据权利要求29所述的护罩,其中所述伸长臂能够通过胶粘或者缝制固牢到头带绑带上。
34.根据权利要求33所述的护罩,其中每个伸长臂能够固牢到上头带绑带上,每个伸长臂的狭槽适于接收后头带绑带,而每个下头带连接器适于连到下头带绑带上。
35.根据权利要求34所述的护罩,其中下绑带和后绑带适于在使用中以一角度会合并经过患者头的后面。
36.一种面罩系统,包括:
框架,其限定呼吸腔室;
衬垫,其设置于所述框架上并且适于与患者的面部形成密封;
护罩,其设置于所述框架上并且适于与头带相连;以及
肘管,其设置于所述框架上并且适于连接到将可呼吸气体输送给患者的空气输送管,
其中所述护罩包括构造为建立所述护罩和所述框架之间刚性连接的固定机构。
37.根据权利要求36所述的面罩系统,其中所述框架包括环绕适于与所述肘管连通的开口的凸颈圈。
38.根据权利要求37所述的面罩系统,其中所述固定机构包括配置为夹在所述肘管和所述框架之间的一个或者多个突出部。
39.根据权利要求38所述的面罩系统,其中所述肘管包括环形突起,所述环形突起构造为将所述一个或者多个突出部夹在所述凸颈圈与环形突起之间。
40.根据权利要求39所述的面罩系统,其中所述凸颈圈包括一个或者多个适于接收设置在所述护罩上的相应突出部的凹槽。
41.根据权利要求37-40中任一项所述的面罩系统,其中所述固定机构还包括一个或者多个构造为通过搭扣配合接合所述凸颈圈的搭扣指状件。
42.根据权利要求41所述的面罩系统,其中所述凸颈圈包括一个或者多个适于接合设置在所述护罩上的相应搭扣指状件的突起。
43.根据权利要求37-42中任一项所述的面罩系统,其中所述肘管包括适于在所述开口的边缘下方延伸以将所述肘管固定到所述框架上的远侧台肩。
44.根据权利要求36-43中任一项所述的面罩系统,其中所述框架包括用于气体冲洗的通气口装置。
45.根据权利要求36-44中任一项所述的面罩系统,其中所述衬垫是全面部衬垫。
46.根据权利要求36-45中任一项所述的面罩系统,其中所述护罩包括适于与上头带绑带相连的一对上头带连接器和适于与下头带绑带相连的一对下头带连接器。
47.根据权利要求46所述的面罩系统,其中每个上头带连接器包括伸长臂和在所述臂的自由端处的适于接收相应上头带绑带的狭槽。
48.根据权利要求46-47中任一项所述的面罩系统,其中每个下头带连接器包括适于与和相应下头带绑带联接的头带夹子可拆卸地互锁的夹子插口。
49.根据权利要求46-48中任一项所述的面罩系统,其中每个上头带连接器被适当地形成、成形或定轮廓为遵循患者面部的轮廓并在使用中避开患者的视线。
50.根据权利要求36-49中任一项所述的面罩系统,其中所述框架的顶端包括一个或者多个适于接收设置在所述护罩的内侧上的相应柄脚突起的狭槽。
51.根据权利要求36-50中任一项所述的面罩系统,其中所述肘管包括反窒息阀。
52.一种面罩系统,包括:
限定呼吸腔室的框架;以及
设置于所述框架上的衬垫,所述衬垫包括主体和衬垫,其中所述衬垫适于接合患者面部的至少一部分,并且所述衬垫包括连接到底衬垫层和隔膜的基壁,其中所述隔膜绕着所述衬垫的周边延伸并接触患者面部,而且其中所述底衬垫层位于所述隔膜下面并支撑所述隔膜,而且其中所述底衬垫层在面部的预定区域对所述隔膜提供不同的支撑。
53.根据权利要求52所述的面罩系统,其中所述底衬垫层的厚度或刚度变化以提供不同的支撑。
54.根据权利要求52所述的面罩系统,其中所述隔膜下方的预定区域中没有所述底衬垫层以提供不同的支撑。
55.根据权利要求52-54中任一项所述的面罩系统,其中所述面部的预定区域包括:鼻梁和/或下巴。
56.根据权利要求55所述的面罩系统,其中所述框架模块连到适于接合患者头部的头带上。
57.根据权利要求55所述的面罩系统,其中所述框架模块是由尼龙制成的。
58.根据权利要求55所述的面罩系统,其中所述主体是由聚碳酸酯制成的。
59.根据权利要求55所述的面罩系统,其中所述衬垫是由磨砂硅树脂制成的。
60.一种医疗应用中使用的面罩组件,其具有由其相对于患者面部的位置所限定的顶端和底端,其中所述面罩组件连接到适于接合患者头部的多个柔性绑带上,并且其中所述柔性绑带接合至少两个整体模制到面罩组件的一部分上的刚性伸长臂,并且其中所述伸长臂是接近所述面罩组件的顶端而模制到所述面罩组件上的。
61.根据权利要求60所述的面罩组件,其中所述臂是大体弓形的。
62.根据权利要求61所述的面罩组件,其中所述臂适于沿平行于患者脸颊的方向从所述面罩组件延伸出并在患者视野下方延伸。
63.根据权利要求60所述的面罩组件,其中所述面罩组件覆盖患者的鼻部和嘴部。
64.一种医疗应用中使用的面罩组件,包括连接到衬垫的适于覆盖鼻部和/或嘴部的主体,其中所述面罩组件是通过基本垂直地朝向面部的力所附连的,其中所述力沿着面罩的长度是近似恒定的,并被所述衬垫的接合患者脸颊的一部分平衡。
65.根据权利要求64所述的面罩组件,其中所述衬垫的所述一部分比所述衬垫的其他区域相对更硬。
66.根据权利要求65所述的面罩组件,其中所述衬垫的所述一部分是由所述衬垫的两侧所限定的。
67.根据权利要求66所述的面罩组件,其中所述衬垫的两侧接合患者的脸颊并且在使用时稳定所述面罩组件。
68.根据权利要求67所述的面罩组件,其中与所述衬垫的两侧相比,在所述衬垫的适于接合鼻梁或者下巴的区域处所述衬垫相对软。
69.根据权利要求68所述的面罩组件,其中所述力是由接合所述面罩组件的绑带提供的,所述绑带通过连到至少两个在沿着患者脸颊的方向上延伸离开所述面罩组件的伸长臂上来接合所述面罩组件。
70.根据权利要求69所述的面罩组件,其中所述臂被定形为通过避开患者的眼睛区域来避免限制患者的视界。
71.根据权利要求70所述的面罩组件,其中加垫衬套包封臂的至少一部分。
72.根据权利要求71所述的面罩组件,其中所述衬套是相对弹性的柔性管。
73.一种与医用面罩一起使用的衬垫,包括:
适于可密封地接合面部的外侧隔膜层;和
适于支撑所述隔膜层的底衬垫层,
其中隔膜或底衬垫层包括位于这两个层之间的表面,所述表面适于允许这两个层贴着相应表面滑动。
74.根据权利要求73所述的衬垫,其中所述隔膜层没有所述底衬垫层硬。
75.根据权利要求74所述的衬垫,其中所述隔膜层是由磨砂的聚合体或硅树脂制成的。
76.根据权利要求75所述的衬垫,其中所述底衬垫层是由磨砂的聚合体或硅树脂制成的。
77.一种面罩系统,包括:
框架,其限定呼吸腔室;
衬垫,其设置于所述框架上并且适于与患者的面部形成密封;以及
可释放的护罩,其适于接合所述框架的外表面的一部分,其中所述护罩连接到绑带上以定位所述面罩系统。
78.根据权利要求77所述的面罩系统,其中所述护罩通过使用连接器来接合所述框架。
79.根据权利要求78所述的面罩系统,其中所述护罩包括至少两个整体模制的伸长臂。
80.一种医疗应用中使用的面罩组件,包括:
上端和下端,其中所述上端适于覆盖鼻部而所述下端适于覆盖患者嘴部,
其中所述面罩组件不包括前额支架,而包括两个在所述面罩组件的相对侧连到所述上端上的加强构件,其中所述加强构件具有大体弯曲的形状并适于避免遮盖患者视野。
81.根据权利要求80所述的面罩组件,其中所述加强构件以10°和20°之间的角度远离水平轴弯曲。
82.根据权利要求80所述的面罩组件,其中所述加强构件以大约17°的角度远离水平轴弯曲。
83.一种连到医用面罩上的衬垫,其中所述衬垫是柔性的并包括:隔膜和至少一个底衬垫,所述隔膜连到所述衬垫的周缘上并适于相对患者面部密封,所述底衬垫适于支撑所述隔膜并位于所述隔膜下面以防止所述隔膜在使用中皱缩;并且其中所述隔膜比所述底衬垫软;其中,当在所述底衬垫的底部和顶端之间进行测量时,所述底衬垫在鼻梁或下巴的区域中的高度在0mm和30mm之间。
84.根据权利要求83所述的衬垫,其中所述底衬垫的高度短于所述隔膜。
85.根据权利要求84所述的衬垫,其中当在所述隔膜的底部和顶端之间进行测量时,所述隔膜的高度在1mm和40mm之间。
86.根据权利要求85所述的衬垫,其中所述衬垫分成两部分以形成所述底衬垫和所述隔膜。
87.一种医疗应用中使用的面罩组件,包括:
上端和下端,其中所述上端适于覆盖鼻部而所述下端适于覆盖患者嘴部,
所述面罩组件不包括前额支架,而包括两个在所述面罩组件的相对侧连到所述上端上的加强构件,其中所述加强构件具有大体弯曲的形状并适于避免遮盖患者视野。
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