CN107137810B - 包括泡沫衬垫元件的接口 - Google Patents

包括泡沫衬垫元件的接口 Download PDF

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CN107137810B
CN107137810B CN201611072310.XA CN201611072310A CN107137810B CN 107137810 B CN107137810 B CN 107137810B CN 201611072310 A CN201611072310 A CN 201611072310A CN 107137810 B CN107137810 B CN 107137810B
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cushion element
cushion
mask system
foam
face mask
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CN107137810A (zh
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莱·詹姆士·韦利斯
勒妮·弗朗西丝·多尔蒂
斯科特·亚历山大·霍华德
艾丽西娅·克里斯蒂安·韦尔斯
菲盎娜·凯萨琳·卡若
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Resmed Pty 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
    • A61M16/06—Respiratory or anaesthetic masks
    • 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
    • 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
    • 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
    • A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
    • 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
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/105—Filters
    • A61M16/106—Filters in a path
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/02—Masks
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
    • A62B18/084—Means for fastening gas-masks to heads or helmets
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment

Abstract

本发明涉及一种包括泡沫衬垫元件的接口。一种呼吸面罩组件，其包括：框架(20)，其具有槽；和衬垫元件(30)，其包括适于过盈密封且保持在所述槽中的夹持部。所述衬垫元件包括由泡沫构成并具有比所述夹持部更宽的宽度的接口部。

Description

包括泡沫衬垫元件的接口
本申请是申请日为2009年3月4日、申请号为200980107829.9且发明名称为“包括泡沫衬垫元件的接口”的中国专利申请的分案申请。
申请的交叉引用
本申请要求于2008年3月4日提交的申请号为AU 2008901056的澳大利亚临时专利申请的权益，其全部内容通过引用合并于此。
技术领域
本发明涉及一种在人体和例如面罩的一件装置之间的接口，其包括泡沫基(foam-based)的衬垫元件。
背景技术
在诸如呼吸治疗的若干领域中，用于输送治疗的器械包括限定结构的较刚性部件和位于患者和刚性部件之间的柔软的、衬垫部件。
就呼吸设备来说，较刚性部件可以是限定鼻部容纳腔的面罩框架。面罩框架可包括围绕其外围的凸缘。衬垫部件可粘贴到凸缘上。见公开号为US 2003/0168063的美国专利申请。
在呼吸治疗的某些形式中，衬垫部件可与患者的皮肤形成气密密封。在例如耳机的其他的设备中，可不需要形成气密密封。
其他已知的包括泡沫衬垫元件的面罩包括下列费雪帕克(Fisher and Paykel)面罩：ACLAIM面罩、FLEX-FIT 405、FLEX-FIT 407以及FLEX-FIT 431。
发明内容
本发明的第一个方案提供一种具有泡沫衬垫元件的患者接口。
本发明的另一个方案提供一种具有可拆卸泡沫衬垫元件的患者接口。
本发明的另一个方案提供一种具有至少两种不同类型的可拆卸替换的衬垫元件的患者接口系统。
本发明的另一个方案包括具有适于接合较刚性部件的部分的衬垫元件。
本发明的另一个方案提供一种包括框架和衬垫元件的呼吸面罩组件，其中衬垫元件包括泡沫基的接口部和适于可拆卸地接合框架部的夹持部。
本发明的另一个方案提供一种用于衬垫元件的支撑结构，其在一侧支撑衬垫元件并且允许在另一侧活动。
本发明的另一个方案涉及一种用于呼吸面罩的衬垫，其包括夹持部和接口部，其中接口部由泡沫材料构成并且夹持部窄于接口部。
本发明的另一个方案涉及一种呼吸面罩组件，其包括具有槽的框架和衬垫元件，该衬垫元件包括适于过盈密封且保持在槽中的夹持部。衬垫元件包括由泡沫构成并且具有比夹持部更宽的宽度的接口部。
本发明的另一个方案涉及一种呼吸面罩组件，其包括具有槽的框架和可拆卸地替换的接口结构，该接口结构包括适于过盈密封且保持在槽中的夹持部。接口结构包括由泡沫构成的衬垫部件。
本发明的另一个方案涉及一种面罩系统，其包括共同的框架和至少第一衬垫和第二衬垫，第一衬垫由泡沫构成，第二衬垫由硅树脂构成。第一和第二衬垫各自被构造成可拆卸地连接到框架上。
本发明的其它方案、特征以及优点在结合附图的下列详细说明中将变得更加明显，附图为本公开的一部分并且通过示例的方式示出了本发明的原理。
附图说明
附图有助于对该发明的各个实施例的理解，其中：
图1示出根据本发明的实施例的包括泡沫衬垫元件的面罩组件的侧视图；
图2示出根据本发明的实施例的面罩框架的一部分的槽和衬垫元件的通过过盈配合保持的夹持部的示意图；
图3a、3b和3c示出根据本发明的实施例的在面罩框架和衬垫元件的夹持部之间的肋接合配合方式的范围；
图4a示出根据本发明的实施例的衬垫元件的患者接触侧；
图4b示出图4a的衬垫元件的仰视图；
图4c示出图4a的衬垫元件的俯视图；
图4d示出图4a的衬垫元件的侧视图；
图4e示出图4a的衬垫元件的框架接触侧；
图4f示出图4a的衬垫元件的患者接触侧等距视图；
图4g示出图4a的衬垫元件的框架接触侧等距视图；
图5a为示出根据本发明的实施例的冲切衬垫元件的平面图，其中夹持部包括用于接合框架的狭槽；
图5b为在图5a中示出的衬垫元件的等距视图；
图5c为在图5a中示出的衬垫元件与面罩框架的组装图；
图6a示出现有技术的具有泡沫衬垫的鼻罩的截面图；
图6b示出图6a的面罩的鼻梁区域的细节；
图7a示出图4e中示出的衬垫元件的框架侧的立面图细节；
图7b为沿着图7a的线7b-7b的截面图；
图7c为示出在使用中的图7a和7b的衬垫元件的截面图；以及
图8为示出根据本发明的实施例的图7a和7b的衬垫元件和框架的组装的截面图。
具体实施方式
下面提供的描述涉及一些可以享有共同的特性和特征的实施例。应当理解的是，任何一个实施例的一个或多个特征可与其它实施例的一个或多个特征相结合。另外，在任何实施例中的任何单个特征或特征的结合可构成另外的实施例。
在此说明书中，词语“包括”应理解成它的“开放式”含义，就是说，是“包含”的含义，而不局限于其“封闭式”含义，也就是“只包括”的含义。出现的相应词语“包括(comprise)”、“包括(comprised)”及“包括(comprises)”被赋予相对应的含义。
术语“空气”将包括可呼吸的气体，例如具有补充氧气的空气。
衬垫元件和器械的互相连接
根据本发明的实施例，提供了一种可拆卸互相连接的衬垫元件(也称为软垫元件或衬垫)。衬垫元件优选地包括用于接触人体的柔软有弹性的泡沫接口部。衬垫元件被构造成并且布置为与诸如呼吸面罩的其余器械可拆卸的互相连接。
可拆卸地连接衬垫元件的能力使得人们能够在它变脏和/或不舒适时替换衬垫元件。它还有助于试用不同形式的衬垫元件。一种形式的衬垫元件，例如泡沫基的衬垫元件，可用作一种形式的“练习”系统来使人们习惯佩戴和使用面罩的感觉。与凝胶或硅树脂基(silicone-based)衬垫相比，基于泡沫衬垫的面罩可提供对于新患者来说起初更吸引人和舒适的表面。之后，患者可从泡沫基的衬垫转换到硅树脂或凝胶基(gel based)衬垫。这样，患者可更有可能坚持治疗，因为他们习惯了泡沫的很柔软舒适的感觉。
当被应用于呼吸装置时，衬垫元件适于与面罩框架连接。在使用时，在衬垫元件和框架之间形成气密密封。这种布置方式能够既用于鼻罩又用于全面式面罩。
例如，图1示出了包括面罩框架20和设置在面罩框架20上的泡沫基衬垫元件30的面罩10。如图所示，泡沫基衬垫元件30提供了在使用时适于接触患者面部的泡沫接口部32。在该实施例中，泡沫基衬垫元件30适合与现有的面罩(例如雷斯梅德的梦幻跨越(MirageQuattro)面罩)一起使用，这使得如果需要的话患者可以从泡沫基衬垫元件30转换到面罩的现有的硅树脂基衬垫。
双泡沫层
在根据本发明的实施例的设备的一种形式中，泡沫基衬垫元件具有两层，即接口部和夹持部。
在实施例中，接口部或衬垫由柔软的无皮弹性的粘弹聚氨酯泡沫构成。在于2008年1月31日公开的公开号为WO 2008/011682和于2008年6月19日公开的公开号为WO 2008/070929的PCT中公开了这种泡沫，每个PCT的的全部内容通过引用合并于此。在一种形式中，有弹性的泡沫可通过诸如冲切的已知方法形成。
图4a至4g示出根据本发明的实施例的泡沫基衬垫元件230。如图所示，衬垫元件230包括接口部或面部接触部232和设置在接口部232上的夹持部234。在该实施例中，夹持部234适合与面罩框架过盈配合，并且夹持部234的宽度窄于接口部232的宽度(例如，见图4e和4g)。
在示出的实施例中，泡沫接口部232的内表面和外表面都被冲切。这典型地导致直的切割边缘，更像厨房海绵体。该衬垫因此可具有正方形的截面。
在实施例中，衬垫元件的夹持部可由比接口部更刚性的泡沫构成。例如，夹持部可由吹氮聚乙烯、或一些其他的具有细微囊室结构的纯净的适合生物的泡沫形成。可替代地，夹持部可由一些其他的聚合物或橡胶制成。在实施例中，夹持部适合于形成衬垫-框架接合机构并且适合于形成用于接口部的结构支撑。
两层(即接口部和夹持部)可使用聚氨酯热熔性粘合剂而互相粘接。这种布置方式提供了一件具有适于接合患者面部的接口部和适于与面罩框架接口的夹持部的衬垫元件。
衬垫-框架接合机构
根据本发明的一个方案，由夹持部提供的衬垫-框架接合和连接机构可包括槽式接合或肋式接合。
如图2所示，槽式接合包括泡沫夹持部34，其适于以过盈配合被容纳在面罩框架20的槽22内。泡沫夹持部34围绕衬垫元件的整个圆周延伸以便与面罩框架形成气密密封和保持力。
如图3a至3c所示，肋式接合包括具有一个或更多个狭槽38的泡沫夹持部34以容纳面罩框架20的内部肋23和/或外部肋24。例如，狭槽到肋的接合可提供内部框架肋接合(见图3a)、外部框架肋接合(见图3b)、或内和外框架肋接合(见图3c)。这种布置方式提供了用于密封泡沫的更宽的支撑基部。
图5a和5b示出了包括泡沫接口部832和夹持部834的泡沫基衬垫元件830，并且图5c示出了设置在面罩框架20上的衬垫元件830。如图5a和5b所示，夹持部834包括适于容纳面罩框架20的肋的狭槽838。而且，提供的更宽的夹持部834允许向夹持部提供更大的强度和结构整体性，使得夹持部更易于组装到面罩框架上。
当被构造成与面罩框架形成过盈配合时，夹持部可具有下列性质：合适的刚度(例如，小于框架的刚度并且呈现比泡沫接口部更刚性的一种形式)；无孔；以及/或在释放压缩应力后材料所保持的低压缩变定(变形量表示成原始尺寸的百分比)(这样，夹持部在它的使用寿命期间保持其保持力)。
接口部支撑结构
根据本发明的实施例，可提供夹持部和泡沫接口部的不同布置方式的范围。例如，夹持部的宽度可与接口部相一致，夹持部的宽度可小于接口部的宽度，或者夹持部的宽度可大于接口部的宽度。
当夹持部的宽度小于接口部的宽度时，夹持部和接口部可以如下方式布置：(i)夹持部的外周边和接口部对齐(隐藏夹持部的硬度并且提供在接口部中的活动的理想的自由度)；(ii)夹持部的内周边和接口部对齐；或(iii)夹持部的内周边或外周边都不和接口部对齐。
类似地，当夹持部的宽度大于接口部的宽度时，夹持部和接口部可以如下方式布置：(i)夹持部的外周边和接口部对齐；(ii)夹持部的内周边和接口部对齐；或(iii)夹持部的内周边或外周边都不和接口部对齐。
在这些具有不同的相对宽度的不同的构造中，夹持部提供了接口部的不同形式的支撑。
当夹持部的宽度小于接口部的宽度并且夹持部的外周边与接口部对齐时，接口部在不具有紧邻它的夹持部的区域中比在具有紧邻它的夹持部的区域中更加自由地弯曲。例如，在接口部突出于夹持部之外的地方，接口部的那个突出区域具有更多的自由度来活动。这种布置方式可更加的舒适并且更能适于人的不同的几何形状，并且能够提供正确的向量(vector)来使接口部密封在面部上。
当被用作互相面罩的部分时，可优选的是接口部的内部突出于夹持部之外。在使用时的这种布置方式中，患者的面部可与较柔软的接口部的无支撑的内缘接合，使得它弯曲并符合单个的患者的形状。
图7a示出了从图4e中示出的衬垫元件230的框架侧在鼻梁区的立面图细节。如图7b中的横截面所示，明显的是夹持部234的宽度w2小于接口部232的宽度w1并且夹持部234的外周边和接口部232对齐。在图7c中示出了这种布置方式的优点，其中在使用时鼻部能够沿由箭头示出的方向以悬臂的方式推动并且挤压接口部232的内周边。
图8为示出了容纳在面罩框架20的槽22内的衬垫元件230的夹持部234的截面图。可以看出，夹持部234的宽度小于接口部232的宽度，并且夹持部234外周面236和接口部232的外周面238对齐，而各个内周面240、242偏离。
这种布置方式与现有技术的衬垫(比如在图6a和6b中示出的养生(Lifecare)面罩)相反，其中衬垫C的内周边紧挨着框架F，因此它不能自由地向内活动并且只能压缩。
在一种形式中，面罩系统可设置成包括从泡沫基衬垫、硅树脂基衬垫、以及凝胶基衬垫的组中选出的至少两种不同形式的衬垫元件。
尽管已经结合目前认为是最实用和最优选的实施例描述了本发明，但是应理解的是，本发明并不局限于所公开的实施例，相反，本发明意图涵盖包括在本发明的精神和范围内的各种改进和等同的方式。同时，上述各种实施例可以结合其它实施例来实施，例如，一个实施例的多个方案可以与另一个实施例的多个方案相结合以形成其他的实施例。此外，任何给出的组件的各个独立特征或部件可以构成另外的实施例。另外，尽管本发明对于患有OSA的患者具有特定应用，但是应理解的是，患有其它疾病(例如，充血性心力衰竭、糖尿病、病态肥胖症、中风和肥胖治疗手术等)的患者也可以从以上教义中获益。而且，上述教义在非医学应用中对于患者和非患者具有同样的实用性。

Claims (11)

1.一种用于向患者输送呼吸治疗的全面式面罩系统，其包括：
共同的刚性框架，其限定鼻部容纳腔；
第一全面式衬垫元件，其使用时能够与患者的皮肤形成气密密封，所述第一衬垫元件可拆卸地连接到所述共同的刚性框架，其中，所述第一衬垫元件是泡沫基衬垫元件并且包括由柔软的弹性泡沫形成的接口部，其被布置为在使用中接触患者的面部；
第二全面式衬垫元件，其使用时能够与患者的皮肤形成气密密封，所述第二衬垫元件也可拆卸地连接到所述共同的刚性框架，使得所述患者能够选择性地选出所述第一衬垫元件和所述第二衬垫元件中的一个以在使用期间连接到所述共同的刚性框架，其中，所述第二衬垫元件是硅树脂基衬垫；
其中所述共同的刚性框架包括由内部肋和外部肋形成的槽；
其中第一衬垫元件和第二衬垫元件中的每一个都包括夹持部，所述夹持部适于插入所述槽中并提供过盈密封，从而将所述第一衬垫元件和第二衬垫元件中对应的一个可拆卸地连接到所述共同的刚性框架上；
其中所述第一衬垫元件的夹持部由泡沫构成，并且包括一个或多个狭槽以容纳所述框架的内部肋和/或外部肋；并且
其中第一衬垫元件的鼻梁区域中的接口部分的内周边在使用中自由悬臂。
2.根据权利要求1所述的全面式面罩系统，其中，所述面罩系统进一步包括由凝胶构成并且被构造成连接到框架上的第三衬垫元件。
3.根据权利要求1所述的全面式面罩系统，其中，在截面图中，在所述第一衬垫元件的径向上，所述夹持部窄于所述接口部。
4.根据权利要求1所述的全面式面罩系统，其中，所述第一衬垫元件的所述夹持部和所述接口部在它们的外周边处对齐。
5.根据权利要求1-4中任何一项所述的全面式面罩系统，其中，所述第一衬垫元件的所述接口部是无皮弹性的粘弹聚氨酯泡沫。
6.根据权利要求1所述的全面式面罩系统，其中，所述接口部具有在0至50L/s/m^2的范围内的透气率。
7.根据权利要求1所述的全面式面罩系统，其中，所述第一衬垫元件的所述夹持部具有第一侧和第二侧，所述第一侧适于与所述共同的刚性框架连接，所述第二侧连接到所述第一衬垫元件的接触区域，以及
其中，所述第一衬垫元件的所述接口部的突出区域延伸超出所述夹持部，并且被构造为在使用时患者的面部与所述接口部接合时在所述夹持部上弯曲。
8.根据权利要求7所述的全面式面罩系统，其中，在截面图中，在所述第一衬垫元件的径向上，所述夹持部的宽度窄于所述接口部的宽度。
9.根据权利要求7所述的全面式面罩系统，其中，所述夹持部的外周边和所述第一衬垫元件的所述接口部的外周边对齐。
10.根据权利要求7所述的全面式面罩系统，其中，所述夹持部使用粘合剂粘接到所述第一衬垫元件。
11.根据权利要求10所述的全面式面罩系统，其中，所述粘合剂是聚氨酯热熔性粘合剂。
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