CN101155610B - 用于患者界面的衬垫 - Google Patents

用于患者界面的衬垫 Download PDF

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CN101155610B
CN101155610B CN2006800021694A CN200680002169A CN101155610B CN 101155610 B CN101155610 B CN 101155610B CN 2006800021694 A CN2006800021694 A CN 2006800021694A CN 200680002169 A CN200680002169 A CN 200680002169A CN 101155610 B CN101155610 B CN 101155610B
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阿龙·塞缪尔·戴维森
罗宾·加思·希契科克
马修·伊夫斯
戴维·约翰·沃博伊斯
苏珊·R·林奇
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Resmed Pty Ltd
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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
    • A61M16/0616—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
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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
    • A61M16/0057—Pumps therefor
    • 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
    • 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
    • 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
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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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture

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  • Health & Medical Sciences (AREA)
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Abstract

一种用于为患者输送可呼吸气体的患者界面的衬垫，所述衬垫包括被构造成与框架相连的基壁(28)，在使用中从基壁(28)朝的患者面部延伸的下支撑衬垫(30)，以及被设置为至少基本覆盖下衬垫(30)的一部分的膜状物(32)。膜状物(32)适于在患者面部形成连续密封。下衬垫(30)具有与基壁(28)的弹簧状连接。下衬垫(30)和/或基壁(28)限定了沿密封的长度变化的弹簧常数。

Description

用于患者界面的衬垫
相关申请的交叉参考
本申请要求于2005年1月12日提交的美国临时申请号为60/643,130和于2005年10月7日提交的美国临时申请号为60/724,303的优先权，每一篇的全文结合在此作为参考。
技术领域
本发明涉及用于患者界面的衬垫，所述患者界面用于例如用非侵入性正压通气(NPPV)治疗睡眠呼吸紊乱(SDB)的治疗中。
背景技术
采用NPPV治疗例如阻塞性睡眠呼吸暂停(OSA)的SDB，由Sullivan倡导(见美国专利第4,944,310号)。治疗SDB的装置包括鼓风机，该鼓风机通过导管将空气以正压输送到患者界面。患者界面可采用几种形式，如鼻面罩组件和口鼻面罩组件。典型地，患者在睡眠时戴面罩以接受NPPV治疗。
典型地，面罩组件包括坚硬的壳体或框架和柔软的面部接触衬垫。衬垫将框架和患者的面部隔开。框架和衬垫限定出容纳鼻子或鼻子和嘴的空腔。框架和衬垫由帽盔组件固定在患者的面部。典型地，帽盔组件包括经过患者面部的两侧到达患者头部的后方或顶部的带子。
美国专利第5,243,971号(Sullivan和Bruderer)描述了用于持续气道正压通气(CPAP)的鼻面罩组件，该组件具有与患者鼻子和面部轮廓相符合的鼓胀/模制密封件。面罩组件具有安装到壳体上的面部接触部分，壳体的尺寸和形状符合患者的鼻子区域。面部接触部分是由弹塑性材料模制出的可延展膜状物的形式。可延展膜状物和壳体共同限定出空腔。流入空腔的加压空气使膜状物从患者面部向外延展。该专利的内容结合在此作为参考。
美国专利第6,112,746号(Kwok等)描述了鼻面罩组件及其面罩衬垫。该专利的内容结合在此作为参考。衬垫包括基本呈三角形的框架，膜状物从该框架中延伸。框架具有边缘，衬垫通过该边缘附着到面罩体。膜状物具有孔，患者的鼻子容纳在该孔中。膜状物与框架边缘间隔开，并且其外表面与边缘的形状基本相同。
患者界面的衬垫在治疗的舒适度和有效性上可起关键作用。面部尺寸和形状存在诸多不同，这意味着为一种面部类型设计的面罩可能不适合另一种。例如，亚洲式的鼻子趋于具有矮鼻梁，而高加索式鼻子趋于具有高鼻梁。采用错误的衬垫可导致过度漏气和不舒适。虽然为每个患者定做面罩可解决一些不适问题，但定制的面罩会非常昂贵。因此，制造商寻求研制为一定范围的面部尺寸和形状提供舒适和有效密封的衬垫。
发明内容
本发明的一方面是提供患者界面，该界面在保持有效密封的同时为患者提供更多舒适感。
本发明的另一方面是提供用于患者界面的舒适衬垫，该衬垫适合大范围的面部形状和尺寸。
本发明的另一方面涉及包括下衬垫和膜状物的衬垫，其中下衬垫和膜状物在衬垫的鼻子区域具有基本平坦的部分。
本发明的另一方面涉及包括基壁、下衬垫和膜状物的衬垫，其中基壁和下衬垫具有提供环绕衬垫周长的可变弹簧常数的横截面结构。
本发明的另一方面涉及患者界面，其中衬垫的基壁和框架连接物相对于最外部衬垫点，例如外部膜状物表面，向内偏移。
本发明的另一方面涉及包括基壁和下衬垫的衬垫，所述基壁和下衬垫在衬垫的鼻翼区域倾斜或成角度。
本发明的另一方面涉及具有与其面部高度无关的基本恒定的嘴宽度的衬垫。本发明的另一方面涉及用于患者界面的衬垫，该患者界面为患者输送可呼吸气体。所述衬垫包括，构造成与框架相连的基壁，从基壁朝使用中的患者面部延伸的下支撑衬垫，以及至少基本覆盖下衬垫一部分的膜状物。膜状物包括鼻梁、面颊和下巴区域，适于分别在患者面部的鼻梁、面颊和下巴区域形成连续密封。鼻梁区域和相邻的两个面颊区域限定出交叉处或顶点。鼻梁区域的膜状物在交叉或顶点处的高度大于面颊区域的邻近部分的高度。
本发明的另一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物适于在患者面部形成连续密封。下衬垫具有与基壁的弹簧状连接，下衬垫和/或基壁限定了沿密封长度变化的弹簧常数。
本发明的另一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物适于在患者面部形成连续密封。所述膜状物和所述下衬垫中的一个包括外表面，所述外表面限定了衬垫的外部宽度，并且基壁相对于所述外表面向内偏移。
本发明的又一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物至少包括适于分别在患者面部的鼻梁和鼻翼区域形成连续密封的鼻梁和鼻翼区域。所述鼻翼区域的基壁和下衬垫相对于框架底部倾斜或成角度。
本发明的又一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物包括适于分别在患者面部的鼻梁、鼻翼、上面颊、下面颊和下巴区域形成连续密封的鼻梁、鼻翼、上面颊、下面颊和下巴区域。所述膜状物的内边缘限定了容纳患者的鼻子和嘴的孔。容纳患者的嘴的孔的下部的嘴宽度基本保持恒定，且与衬垫的面部高度无关。
本发明的又一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物适于在患者面部形成连续密封。下衬垫和/或基壁的至少一部分具有包括弹性结构的下部，所述弹性结构限定了衬垫相对于从框架施加的力的位移。
本发明的再一方面涉及设计一系列面罩组件的方法。所述方法包括提供适于满足更大范围的患者的第一衬垫；及提供适于满足更小范围的患者的第二衬垫。第一和第二衬垫的每个均包括至少容纳患者嘴的孔，所述第一和第二衬垫的孔具有相同的宽度。
本发明的再一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物至少包括适于在患者面部的鼻梁区域形成连续密封的鼻梁区域。所述膜状物在鼻梁区域形成延长的脊。延长的脊的倾斜侧相接形成延长的顶部。每个倾斜侧与顶部中心线所成的角度均在30至60°的范围内，并且顶部的曲率半径在1.0至5.0mm的范围内。
本发明的再一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物至少包括适于在患者面部的鼻梁区域形成连续密封的鼻梁区域。所述膜状物的鼻梁区域包括轮廓部，所述轮廓部沿半径朝衬垫的空腔向内弯曲从而在所述膜状物的内边缘截止。所述轮廓部具有的自由端相对于所述衬垫的面部接触平面所成角度在30至50°的范围内。
本发明的再一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物适于在患者面部形成连续密封。所述下衬垫和/或基壁呈问号或镰刀形。
本发明的再一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物适于在患者面部形成连续密封。所述下衬垫具有的弧形结构包括大于16mm的弧长。
本发明的再一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及膜状物，其设置为基本覆盖下衬垫的至少一部分。所述膜状物适于在患者面部形成连续密封。所述膜状物所包括沿所述密封的长度变化的厚度。
本发明的再一方面涉及用于为患者输送可呼吸气体的患者界面的衬垫。所述衬垫包括：基壁，其被构造成与框架连接；及膜状物，其适于在患者面部形成连续密封。基壁的至少一部分包括朝所述膜状物逐渐变细的锥形部分。
本发明的再一方面涉及面罩系统，该系统包括至少由为适合不同面部尺寸配置的两个衬垫组成的一组衬垫，其中所述至少两个衬垫具有基本相同的宽度。
本发明的其它方面、特征和优点从与附图结合的下述详细说明将变得明显，其中上述附图是本公开的一部分并且其通过例子的方式阐明了本发明的原理。
附图说明
附图有利于本发明多个实施例的理解。在这些附图中：
图1至9图示了用于患者界面的衬垫，该衬垫根据本发明的实施例构造并示出了实施例的示例性尺寸；
图10至14是图5中所示衬垫的横截面图；
图15是图1至9中所示衬垫的正视图，该图说明衬垫的不同区域；
图16至17图示了图1至9中所示衬垫的另一种尺寸；
图18至19图示了图1至9中所示衬垫的又一种尺寸；
图20至21图示了图1至9中所示衬垫的再一种尺寸；
图22是图1至9中所示衬垫的横截面图，该图图示了可改变下衬垫的弹簧特性(spring characteristic)的参数；
图23至29是图15中所示衬垫的横截面图，并且示出了实施例的示例性参数，横截面图仅图示了下衬垫；
图30A至30N是图示了根据本发明的衬垫的选择性实施例的横截面图；
图31至32是说明图1至9中所示衬垫的实施例和由ResMedLtd.以
Figure S06802169420070717D000081
Face为名称商业销售的已知衬垫中力和位移之间的总体关系的图；
图33是图示了图23至29中所示衬垫的不同横截面的力和位移之间的总体关系的图；
图34A图示了图1至9中所示衬垫的弹性长度，并且示出了根据本发明实施例的示例性尺寸；
图34B图示了由ResMed Ltd.以
Figure S06802169420070717D000082
Face为名称商业销售的已知衬垫的弹性长度，并图示了
Figure S06802169420070717D000083
Full Face的示例性尺寸；
图35是图1至9中所示衬垫的侧视图；
图36至37是图35中所示衬垫的横截面图；
图38是图1至9中所示衬垫的正视图，图示了该衬垫的平坦的部分；
图38B是图示了图1至9中所示衬垫的实施例和由ResMedLtd.以
Figure S06802169420070717D000084
Full Face为名称商业销售的已知衬垫在鼻梁区域内力和位移之间的总体关系的图，并说明；
图39至40B是图1至9中所示衬垫的正视图和横截面图，并示出了根据本发明的实施例的示例性尺寸；
图41至45是图1至9中所示衬垫的实施例的透视图，示出了使用中的鼻梁区域的滚动动作；
图46至53图示了由ResMed Ltd.以
Figure S06802169420070717D000091
 Face为名称商业销售的已知衬垫；
图54至58图示了根据本发明的另一个实施例的用于患者界面的衬垫，并示出了该实施例的示例性尺寸；
图59至63是图54中所示衬垫的横截面图；
图64是与由ResMed Ltd.以
Figure S06802169420070717D000092
Face为名称商业销售的已知衬垫的横截面相重叠的图54至58中所示衬垫的一部分(实线部分)的横截面图(只有
Figure S06802169420070717D000093
的相关部分可由虚线表示，即可能有其它不同部分未示出)；
图65是示出了根据本发明的实施例的示例性尺寸的图54至58中所示衬垫的一部分的横截面图；
图66至69是图54中所示衬垫的横截面图，并示出了根据本发明的实施例的示例性尺寸；
图70至71分别是图54中所示衬垫的平面图和横截面图，示出了根据本发明的实施例的示例性尺寸；
图72至76图示了根据本发明另一个实施例的用于患者界面的衬垫；
图77至83图示了根据本发明另一个实施例的用于患者界面的衬垫；
图84至90图示了根据本发明另一个实施例的用于患者界面的衬垫；
图91图示了图34A中所示衬垫的选择性衬垫横截面；
图92图示了图34A中所示衬垫的另一个选择性衬垫横截面；
图93图示了图15中所示衬垫的选择性衬垫结构；
图94A至94C是描述穿过图35中衬垫的鼻梁区域的水平横截面的一组视图；及
图95A至95C是描述穿过图51中现有技术衬垫的鼻梁区域的水平横截面的一组视图。
具体实施方式
图1至14说明根据本发明实施例进行构造的衬垫10。衬垫10适于活动地或永久地连接(例如通过机械地和/或粘合紧固)到患者界面的框架，该框架构造为患者输送可吸呼气体。在实施例中，衬垫10可共同模制到患者界面的框架。在另一个实施例中，衬垫可形成具有外部支撑结构的框架的一部分，为例如Resmed的Hospital NasalMask。衬垫10在使用中提供患者面部的密封。
在图示的实施例中，衬垫10形成全脸面罩的一部分。特别地，衬垫10提供环绕患者的鼻子和嘴的密封，从而将可呼吸气体输送到患者的鼻子和嘴。然而，本发明的一些方面可应用于其它呼吸装置，例如鼻面罩，口面罩等。如美国专利申请第10/655,622号所述，衬垫10可与角撑板一起使用，在此结合其全文作为参考。
衬垫10被构造成给大范围的面部形状和尺寸提供更舒适的安装。同样，如下文所述，衬垫10被构造成提供更好的密封并减小漏气的风险。
如图1至14所示，衬垫10包括非面部接触部分12，其构造成例如通过摩擦配合、舌榫装置等连接到患者界面的框架，以及构造成接合患者面部的面部接触部分14。
如图5和15最佳地表示出，优选地，衬垫10的面部接触部分14大致呈三角形，并且构造为连续地接触患者的鼻梁、鼻翼、上面颊、下面颊以及下巴区域。然而，面部接触部分14可具有其它适当的形状，例如大致呈梯形。在图示的实施例中，如图15最佳地表示出，衬垫10包括鼻梁区域16以提供沿患者鼻梁的密封，一对面颊区域15以提供沿患者鼻子、面颊和嘴的密封，以及下巴区域20以提供沿患者下巴的密封。一对面颊区域15可进一步限定为一对鼻翼区域17以提供沿患者鼻翼的密封，一对上面颊区域18以提供沿患者上面颊的密封，和一对下面颊区域19以提供沿患者下面颊和患者嘴侧的密封。
衬垫在下面颊区域的宽度以及面罩尺寸的面部宽高的比例
为了适应多种面部尺寸，可提供多种尺寸的衬垫10。例如，图16至21图示了三种其它尺寸的衬垫10。在实施例中，图16至17所示的衬垫210可表示特别小的尺寸，图18至19所示的衬垫310可表示小尺寸，图1至14所示的衬垫10可表示中等尺寸，图20至21所示的衬垫410可表示大尺寸。如图所示，衬垫10、210、310、410的嘴宽度是基本与其面部高度无关的常数。
特别的，衬垫10限定出容纳患者嘴的孔22。在优选实施例中，孔22的下部具有对于所有衬垫尺寸的恒定宽度，例如60mm。然而，孔22的下部的宽度对于所有衬垫尺寸可基本恒定，如在5mm的范围内。例如，衬垫10的孔22的下部的宽度可是60mm±5。相反，ResMed Ltd.以Face为名称商业销售的已知衬垫700的孔722的下部的宽度是，用于大尺寸的60mm，中等尺寸的为54mm，小尺寸的为52mm。图46至53表示出
Figure S06802169420070717D000122
衬垫700。
人体测量数据表明面部相对较小的患者的嘴宽度不一定比面部相对较大的患者的嘴宽度窄。因此，所有的面部具有基本相同的嘴宽度。因而衬垫10中的孔22的制造得足够宽以容纳大范围的患者并保持恒定或基本恒定，例如在5mm的范围内，而不管为了适合较大面部而进行的面罩的面部高度的改变。这可通过环绕不同衬垫尺寸的下面颊和下巴区域的基本恒定的衬垫几何图形，以及因此得到的不同衬垫尺寸的宽高比的变化看出。例如，每个衬垫10、210、310、410的孔22的下部具有基本相同的宽度。
基壁，下衬垫和膜状物
如图9和10至14最佳地表示出，衬垫10的面部接触部分14包括基壁28，一对从基壁28延伸出的下支撑衬垫30，以及设置为基本覆盖下衬垫30的至少一部分并且为面部接触部分14提供密封结构的膜状物32。基壁28和下衬垫30为膜状物32提供支撑结构。
如图所示，优选地，下衬垫30仅设置在基壁28的横侧，例如在鼻翼、上面颊和下面颊区域17、18、19，尽管下衬垫30可接合或基本环绕患者的鼻子以及下嘴唇或下巴区域。下衬垫30在患者的嘴和面颊处为膜状物32增加硬度。尽管膜状物32比下衬垫30薄是优选的，它们可具有相同厚度或膜状物可比下衬垫厚。同样，去掉在下巴区域20的下衬垫使衬垫10在这个区域内能够与患者面部接合得更紧密，而不是使下巴区域20受到过大压力。即在这个区域内没有下衬垫来限制膜状物32的运动，这可提高这个区域和相邻区域的密封性。此外，在下巴区域20去掉下衬垫使衬垫10能够容纳更多面部形状，并提供更大柔性及允许嘴的运动和张开。
在图示的实施例中，衬垫的面部接触部分14在鼻翼17、上面颊18和下面颊区域19具有双壁结构，即膜状物32和下衬垫30，并且在鼻梁16和下巴区域20内具有单壁结构，即膜状物32，如图10至14所示。在衬垫10的顶部和底部的单壁结构通过使衬垫10的中心弯曲有助于容纳高界标(landmark)，例如尖下巴。这种柔性使得可以用相同衬垫满足更多患者。然而，衬垫10可在衬垫10的任何适当区域，例如面颊、下巴、鼻梁内，具有任何其它适当的结构，例如单壁、双壁、三壁或更多壁的结构。例如，下衬垫30可环绕衬垫10的整个周长延伸。同样，下衬垫30可完全去掉。
如图10至14所示，在衬垫10的不同区域内膜状物的厚度可有所不同。如图所示，在鼻梁区域16和上面颊区域18内的膜状物的厚度是0.3mm，膜状物的厚度在上面颊区域18转变为0.5mm，并且在下面颊19和下巴区域20内保持这个厚度。这个结构通过提供较薄的膜状物在鼻梁上提供更大的柔顺性/伸展性。较低区域不需要这个伸展性，并且此处较厚的膜状物不容易在使用中在患者面部上颤动。
向内偏移的基壁和框架连接物
本发明的另一方面涉及衬垫10的基壁28、下衬垫30，以及膜状物32的尺寸和结构。图48至50图示了
Figure S06802169420070717D000141
衬垫700的基壁728、下衬垫730，以及膜状物732。如图所示，衬垫10的横截面图形与
Figure S06802169420070717D000142
衬垫700不同。
例如，如图11至13最佳地表示出，基壁28和框架连接物29相对于最外衬垫点39，例如膜状物或下衬垫的外表面，向内偏移。相反，衬垫700的基壁728和框架连接物729不相对于最外衬垫点739向内偏移(见图48至50)。这个向内运动的结果是，衬垫10的底部宽度变窄，例如每个底部减小约5mm或2.5mm，这使得衬垫不那么突出，并且节省材料，这意味着减小了重量和成本。同样，较窄的衬垫10提供了用于令使用中的衬垫10向外凸出的较小的自由长度，从而有助于最小化或消除漏气。
如图所示，下衬垫30的下部具有弧度更大的结构，例如半圆形、问号形、镰刀形，该结构在下衬垫30的下部的下方并且邻近基壁28的地方限定出空间34。
在图示的实施例中，衬垫最宽或最外衬垫点是下衬垫30的外表面，且基壁28和框架连接物29相对于该点向内偏移。因此，通过衬垫10的设计，特别是下衬垫弧度的设计，框架在较窄的点处连接，因此框架本身变得更窄。该结构在框架重量、感觉体积和尺寸上有显著优点。该结构也可使面罩内的死区最小化，这将会有助于减小CO2再呼吸。
此外，下衬垫30下方的空间34允许下衬垫30更大范围的运动，以给使用中的下衬垫30以及膜状物32增加更大的柔性。特别地，下衬垫30下方的空间34使下衬垫30能够发生更大位移，例如采用与
Figure S06802169420070717D000151
衬垫700基本相同的空间限制物。此外，空间34使下衬垫30能够在开始回升之前产生更大位移，因此减小不适。因此，该结构提供更加渐进的力，增加舒适度，并能够在更大范围的患者获得密封。
可变弹簧常数(spring constant)
如图所示，下衬垫30具有与基壁28的弹簧状连接，从而使下衬垫30可相对于基壁28运动。即下衬垫30可运动进入空间34(下衬垫30也可运动进入空间33)。当施加框架作用力时提供弹力，并且当释放框架作用力时下衬垫30弹回到其初始位置，下衬垫30和/或基壁28可具有任何适当的弹簧常数，并且弹簧常数可在沿其长度的任何地方发生变化，例如通过变细和/或改变基壁28的厚度，改变下衬垫30的中间和/或下部的厚度。同样，弹簧状连接可沿整个下衬垫30延伸，或弹簧状连接也可位于如颊骨区域的特定区域内。
因此，弹簧特性与基壁28和衬垫10的下衬垫30相结合，弹簧特性使连续可变的弹簧常数与基壁28和下衬垫30相结合，例如每个衬垫区域的壁的硬度可不同，从而满足每个区域的密封需求，该需求可能由于患者的下面部结构而变化。
可通过改变图22所示的多个特性来改变基壁28和下衬垫30的弹簧特性。例如，可通过改变下衬垫高度h，厚度t，半径r和下衬垫偏移量c等改变弹簧特性。应该理解的是，这些参数仅仅是示例性的，可以改变其它参数从而改变基壁28和下衬垫30的弹簧特性。
图23至29图示了下衬垫30和基壁28的实施例中的参数以实现理想的弹簧特性。如图所示，下衬垫30和基壁28被构造成提供环绕衬垫10的周长的可变弹簧常数。即下衬垫30和基壁28的弹簧常数沿鼻翼17、上面颊18、下面颊区域19相异。尽管图23至29示出了衬垫10的特殊参数，应该理解的是这些参数仅仅是示例性的，取决于应用的其它参数也是可行的。
在鼻梁区域16内(例如见图10)，为了提供较高的柔性和符合多种脸形的能力，没有设置下衬垫30。然而，在实施例中，在这个区域内可以具有非常软的弹簧特性的下衬垫30。
在鼻翼区域17(见图23至24)，为了提供横向稳定性从而挤压患者的鼻翼并保持膜状物32与衬垫30接触，提供具有相当硬的弹簧特性的下衬垫30和基壁28。如图所示，这个结构通过相对厚的下衬垫、较小高度以及较小半径实现。在图23所示截面的实施例中，h可以是12mm，r可以是5mm，t可以是2至3mm，b可以是4mm，w1可以是11.5mm，w2可以是8mm。在图24所示截面的实施例中，h可以是14mm，r可以是6至7mm，t可以是2.5mm，b可以是4mm，w1可以是11.5mm，w2可以是9.5mm，并且α可以是22°。应该理解的是这些参数仅仅是示例性的，取决于应用的其它参数也是可行的。
同样，如图24最佳地表示出，鼻翼区域17的基壁28和下衬垫30相对于框架底部旋转大约22度。即基壁28和下衬垫30在衬垫10的鼻翼区域17倾斜或成角度。这种结构进一步增加了横向稳定性，并使作用在膜状物上的力垂直施加到患者鼻翼处的皮肤表面。这进一步帮助膜状物32与患者皮肤接触并防止任何漏气。在进一步的实施例中，这个角度可从15度变化至30度。
在上面颊区域18中(见图25至26)，由于下衬垫的几何形状，下衬垫30和基壁28具有的硬度小于其在鼻翼区域17的硬度，并且大于其在下面颊区域19内的硬度，这提供适应上面颊的更加坚固的骨架结构。在图25所示截面的实施例中，h可以是12至15mm，优选的是13.5mm，r可以是5mm，t可以是2mm，b可以是3mm，且w1可以是11.5mm。在图26所示截面的实施例中，h可以是12至15mm，优选的是13.5mm，r可以是5mm，t可以是2mm，b可以是3mm，且w1可以是11.5mm。应该理解的是这些参数仅仅是示例性的，取决于应用的其它参数也是可行的。
在下面颊区域19中(见图27至29)，下衬垫30和基壁28具有相对较小的弹簧常数。即由于患者的肌肉面颊区域容易变形，下面颊区域19的下衬垫30相当柔软，从而以相对小的力用衬垫形成密封。如图所示，这个结构通过较大的高度h，较大的半径r，以及较薄的下衬垫壁实现。在图27所示截面的实施例中，h可以是14mm，r1可以是5mm，r2可以是7mm，t可以是1.5至2mm，b可以是3.5mm，且w1可以是11.5mm。在图28所示截面的实施例中，h可以是16.5mm，r1可以是6至7mm，r2可以是8mm，t可以是1.5mm，b可以是3.5mm，且w1可以是11.5mm。在图29所示截面的实施例中，h可以是17.5mm，r1可以是6至7mm，r2可以是9至10mm，t可以是1.5mm，b可以是3.5mm，且w1可以是11.5mm。应该理解的是这些参数仅仅是示例性的，取决于应用中得到的其它参数也是可行的。
在下巴区域20内(见图14)，没有设置下衬垫30，尽管也可采用柔性大的弹性区域。下巴区域20提供了不受限制的膜状物区域，该区域允许横向运动，嘴张开或运动，并满足大范围面部形状。
因此，衬垫10可构造成在衬垫的不同区域提供不同的垂直和/或横向硬度。例如，为了在患者的鼻子处提供更大的横向稳定性，鼻翼区域16、17的横向硬度大于其它区域。
基壁和下衬垫的选择性实施例
图30A至30N说明基壁28和下衬垫30的选择性实施例。这些实施例中的每一个均提供允许使用中的下衬垫30的柔性的结构。在图30A中，下衬垫30限定出封闭空间60，该空间可选择性的由加压空气、泡沫、凝胶或弹性材料填充，并适于在使用中抑制下衬垫30的运动。在图30B中，下衬垫30下方的空间34在呼吸腔的内部。同样，下衬垫30具有从呼吸腔的内部朝基壁28弯曲的弧形。然而，下衬垫30可具有任何其它适当的形状。例如，图30C中的下衬垫30呈球根形，可是实心或空心。在图30D中，下衬垫30总体呈Z形。在图30E和30F中，下衬垫30呈球根形(可是实心或空心)，并且下衬垫30下方的空间34具有坡道结构。在图30C、30E和30F中，球根形可选择性地由加压空气、泡沫、凝胶或弹性材料填充，并适于在使用中抑制下衬垫30的运动。在图30E中，空间34的坡道结构适于在使用中将下衬垫30向下导入基壁28，在图30F中，空间34的坡道结构适于在使用中将下衬垫30向内导入呼吸腔。在图30G、30H和30I中，下衬垫30大体呈T形。同样，在图30H和30I中，基壁28在T形下衬垫30的下方限定出封闭空间62。封闭空间62可选择性地由加压空气、泡沫、凝胶或弹性材料填充，并适于在使用中抑制下衬垫30的运动。另外，可通过改变封闭空间62内的压力改变弹簧常数。此外，空间62的下表面可具有坡道结构(如图30H所示)，适于在使用中将下衬垫30向内导入呼吸腔。图30A中封闭空间60的下表面也可具有倾斜结构，用于在使用中定向下衬垫30。在图30J和30K中，下衬垫30具有用于柔软的弹簧特性的延长的截面长度。图30L图示了具有下衬垫30且不具有膜状物的单壁结构。在图30M中，下衬垫30下方的空间34大大增加。在图30N中，弹簧结构设置在基壁28下方。
下衬垫带来的位移
当与衬垫700相比时，在预定大小的力的作用下，空间34使下衬垫30能够产生更大位移。即下衬垫30在给定力的作用下提供更大运动。例如，图31图示了衬垫10和
Figure S06802169420070717D000192
衬垫700之间力和位移的总体关系。如图所示，衬垫10的曲线比
Figure S06802169420070717D000193
衬垫700的指数型曲线平滑。因此，与
Figure S06802169420070717D000194
衬垫700相比，下衬垫的硬度较小且更顺从。注意到的是空间34可由凝胶、硅树脂或其它结构填充，以改变所提供的弹簧特性。
此外，如图31所示，衬垫10在点B10完全压缩或开始回升的位移大于
Figure S06802169420070717D000195
衬垫700在点B700开始回升的位移。此外，开始回升的点B10处的力大于开始回升的点B700。因此，衬垫10增加了开始回升所需的力，并提供更大范围的调整。此外，图31图示了最大和最小舒适的密封力的实例，提供了实现密封所需力的范围的实例。如图所示，在用于衬垫10的该力的范围内的位移A10的范围基本大于在用于
Figure S06802169420070717D000196
衬垫700的该力的范围内的位移A700。因此，衬垫10允许大范围的调整或位移以实现密封，并保证了密封力基本小于回升力，从而使衬垫无须开始回升来实现密封。
图32图示了衬垫10和
Figure S06802169420070717D000197
衬垫700之间力和位移的关系的另一个实施例，在该实施例中，衬垫10的曲线的直线部分的坡度大于图31中衬垫10的曲线的直线部分的坡度。坡度的差异可归因于各自下衬垫30的弹簧常数的差异。因此，图31中表示的衬垫在给定力的作用下的位移大于图32中表示的衬垫。同样，图32中衬垫10的曲线与
Figure S06802169420070717D000201
衬垫700的曲线相交，使衬垫10在较小位移处的力较大，以确保密封，且在较大位移处的力较小，以在更大的位移范围内保持舒适。
图33图示了衬垫10的力和位移之间关系的另一个实施例。在该实施例中，示出了衬垫10的不同区域的典型曲线。特别地，一条曲线表示图23至24中鼻翼区域17的横截面，另一条曲线表示图25至27中上面颊18和下面颊区域19的横截面，又一条曲线表示图28至29中下面颊区域19的横截面。如图所示，衬垫10的下方区域更软或硬度更小。
下衬垫的延伸的弹性长度
图34A和34B图示了柔性下衬垫30的延伸长度，当与例如
Figure S06802169420070717D000202
衬垫700的典型现有技术衬垫相比时，所述下衬垫30用于在衬垫10的选定区域提供更柔软的弹簧特性。长度a到b可变形，因此提供弹簧特性。如图所示，由于下衬垫30的弧度，当与衬垫700(图34B)相比时，衬垫10的长度a到b(图34A)相当长。在图示的实施例中，衬垫10的长度a到b是22.84。然而，在一个实施例中，衬垫10的长度a到b可在16至30的范围内，优选地是20至25，最优选的是22至24。在另一个实施例中，衬垫10的长度a到b可在16至20的范围内。长度b到c硬度相当大，且不会变形以提供弹簧特性。衬垫10的附加长度通过下衬垫30的弧形实现，并且空间34是该形状的结果。这个附加长度为衬垫10增加了柔性和更大范围的运动。图30J和30K图示了实现更大截面长度的其它实施例。
鼻梁区域膜状物的结构
膜状物被构造成环绕患者的鼻梁16、鼻翼17、上面颊18、下面颊19和下巴区域20形成有效密封。本发明的另一方面涉及在衬垫10的鼻梁区域16中的膜状物32的结构，该结构用于改进这个区域的密封和舒适度。
特别地，如图36中的优选实施例和图68中的选择性实施例所示，膜状物32在鼻梁区域16形成延长的脊35，其中倾斜侧36相接形成延长的顶部38。每个倾斜侧36与顶部中心线所成角度在30至60°的范围内，优选的约为47°。顶部38的曲率半径在1.0至5.0mm的范围内，优选地约为2.5mm。如图所示，下衬垫30已经从鼻梁区域16的膜状物32的下方去除，这使这个区域内的膜状物32能够在设置在鼻翼区域17的下衬垫30之间自由运动，如下文所详述，这个膜状物结构在与患者的鼻子结合下产生急剧倒转部分，这改进了鼻梁区域16的适应性、舒适度和密封。相反，
Figure S06802169420070717D000211
衬垫700在这个区域相对平坦(见图52)。
如图37中的优选实施例和图69中的选择性实施例所示，延长的脊35的前端40具有弧形结构。前端40构造成与患者的鼻梁区域相接合，并具有在1.5至7.0mm范围内的曲率半径，优选的约为4.0mm。
鼻梁区域的尖锐横截面轮廓
如图10所示，鼻梁区域16中的膜状物32具有比
Figure S06802169420070717D000221
衬垫700(见图48)的对应部分更尖锐的横截面轮廓。特别地，膜状物32设置有沿半径朝衬垫的空腔向内弯曲的大的轮廓部以在膜状物32的内边缘终止。这个结构更接近患者鼻梁区域的轮廓或弯曲部分。在图示的实施例中，膜状物32相对于衬垫的面部接触平面成角度，例如在30至50°的范围内。相反，衬垫700的相应角度为大约6°。这个结构为患者提供更多的舒适和更好的配合。
鼻梁区域的平坦部分
图38最好地表示出，鼻梁区域16具有基本平坦的部分50，例如在膜状物弯曲部分的顶点，在正视图中，可变形为例如从平坦的鼻梁到较尖的鼻梁的大范围的患者提供更舒适的配合。
特别地，本发明的一方面在鼻梁区域16提供膜状物32，该膜状物将与“平脸”相适应，例如那些低鼻梁的患者。为了实现这个方面，衬垫10具有高于点B或与点B平齐的上部点A(见图38)。鼻梁区域16中的这个高度与滚压边缘相结合，该滚压边缘使膜状物36的表面区域相对于患者的鼻梁区域基本保持平坦。保持膜状物36的表面区域相对于患者的鼻梁区域基本平坦，防止在膜状物边缘漏气。
滚压边缘还允许用于容纳较高鼻梁的运动。这个结构通过使会导致不适和患者疼痛的膜状物不进行“延展”而实现。例如，衬垫10在鼻梁区域16的位移可比约40mm大，例如41mm。相反，
Figure S06802169420070717D000223
衬垫700在鼻梁区域提供大约20mm的位移。在这些位移处，膜状物变得非常紧，即力与位移的关系图中在小的位移处力就开始急剧增大的点(见图38B)。
一些现有技术衬垫中鼻梁区域内衬垫的位移值如下：
ResMedTM
Figure S06802169420070717D000231
Nasal Cushion—16mm
Respironics Comfort Full Face Cushion—26mm
ResMed Bubble Nasal Mask Cushion—43mm
Healthdyne Soft Series Nasal Mask Cushion—17mm
上述位移值决不是衬垫将要覆盖的鼻子深度的精确表示。相反，这些位移值仅是膜状物的柔性和/或范围的表示。因此，例如与衬垫700相比，衬垫10提供了更大柔性和/或范围更大的结构。
在鼻梁区域16中的膜状物32的力与位移的关系图中，在相对小的力的作用下发生大位移。例如，如图38B所示，衬垫10在鼻梁区域16内提供的位移大于
Figure S06802169420070717D000233
衬垫700提供的位移。这使衬垫10在使用中能够容纳相对深的鼻梁。同样，
Figure S06802169420070717D000234
衬垫700的模制(未变形)衬垫状态(即无外力施加)不能舒适地容纳相对平或浅的鼻梁。在实施例中，衬垫700的膜状物破裂以适应浅鼻梁的患者的面部。因此，衬垫10还比
Figure S06802169420070717D000235
衬垫700适应更大范围的鼻梁形状。
此外，如图36所示，膜状物的轮廓与平坦轮廓或鞍形相比顶端更加尖锐(例如与图52中的
Figure S06802169420070717D000236
衬垫700相比)。同样，如图35所示，鼻梁区域16中的平坦部分沿相对平坦的平面P1延伸，这个平面P1与限定框架连接物的平面P2成角度A。
因此，鼻梁区域16中的形状(如顶端)、滚压边缘和高度在相对小的力的作用下发生大位移。这个结构容纳更大范围的患者，例如从矮鼻梁的患者到高鼻梁的患者，同时在很少的力作用于膜状物的情况下保持患者面部的密封。
值得注意的是，衬垫高度可围绕衬垫周长改变，以改变衬垫的不同区域中的柔性或衬垫位移。图94C示出了用于测量衬垫高度(也可参照为膜状物高度)的基准尺寸940—即膜状物的顶点至膜状物接触下衬垫的位置之间的高度。图95C示出了用于测量现有技术衬垫的衬垫高度的基准尺寸950。
膜状物中的孔
如图39至40B所示，膜状物32的内边缘限定出容纳患者的鼻子和嘴的孔22。如图所示，孔22一般呈三角形。同样，孔22具有圆形凹口42，例如锁眼。凹口42改进了多种尺寸和形状的鼻梁区域的密封，特别是尖鼻子的患者。如图40A所示，凹口42具有的曲率半径在1.5至6.0mm的范围内，优选的为约3.0mm。
使用中的衬垫的鼻梁区域的滚动动作
图41至45包括施加到衬垫10的鼻梁区域16的外表面的手绘线以图示与患者的鼻子接合时膜状物32的鼻梁区域16的滚动动作。如上所述，鼻梁区域16中的膜状物32包括倾斜侧36，所述倾斜侧相接形成了图41所示的延长的顶部38。当患者的鼻梁(用小杆模拟)与膜状物32的鼻梁区域16接合时(见图42)，膜状物32产生急剧倒转部分44，其中随着膜状物32在设置于鼻翼区域17的下衬垫30之间运动，倾斜侧36倒转其位置。随着膜状物32与患者鼻梁的接触更紧密，如图43所示，随着膜状物32顺应患者的面部，倒转部分的前沿46朝衬垫10的顶部“滚动”。这个结构具有优点，因为它使衬垫10能够容纳更大范围鼻子轮廓的患者，包括那些在鼻子处具有相对小和相对大的根部深度的鼻子轮廓。图44和45示出了处于完全倒转位置的膜状物32的鼻梁区域16。与患者鼻子的接合产生的急剧倒转部分44提供了更好的密封，并减小了折缝和/或折叠以及相关的不适和漏气的风险。即这个结构用滚动代替对患者的舒适和密封有害的折缝。
选择性实施例
图54至71图示了衬垫510的另一个实施例。在每幅图中，与衬垫10基本相似的衬垫510的部分用相似的附图标记表示。
图64图示了衬垫510的基壁528、下衬垫530以及膜状物532(实线表示)，相比于
Figure S06802169420070717D000251
衬垫700的基壁728、下衬垫730以及膜状物732(虚线表示)。如图所示，衬垫510的横截面轮廓与
Figure S06802169420070717D000252
衬垫700不同。
例如，膜状物532连接到下衬垫530的位置比
Figure S06802169420070717D000253
衬垫700的膜状物的连接位置更向内和向上。这个结构基本去除了设置在
Figure S06802169420070717D000254
衬垫700中的垂直延伸槽731。同样，这个结构使膜状物532的宽度相对于
Figure S06802169420070717D000255
衬垫700的对应部分变窄，例如在0至5的范围内，优选的约为2.5mm。作为这个和非面部接触部分512向内运动的结果，这使衬垫510的总体宽度变窄大约5mm，例如每个底部约2.5mm，这提供了具有较小突出的衬垫并节省材料。同样，更窄的膜状物532在使用中提供了用于衬垫510的更小的自由长度，因此有助于最小化或消除漏气。进一步，基壁528和框架连接物529相对于最外衬垫点，例如下衬垫的外表面，向内偏移。图64还示出了与衬垫700相比时，衬垫510的更长的长度a到b。
图65示出了衬垫510的基壁528、下衬垫530，以及膜状物532的一个实施例中进一步的结构细节和尺寸。例如，空间534的深度在0至4.0mm的范围内，优选的约为3.0mm。
图68图示了鼻梁区域516中的延长的脊535。每个倾斜侧536与顶部中心线所成的角度在30至60°的范围内，优选的约为47°。顶部538的曲率半径在1.0至5.0mm的范围内，优选的约为2.5mm。如图69所示，延长的脊535的前端540的曲率半径在1.5至7.0mm的范围内，优选的约为4.0mm。
图70和71图示了在衬垫510的鼻梁区域516中的平坦部分550。同样，如图71所示，鼻梁区域516中的膜状物532具有的第一部分的曲率半径在50至80mm的范围内，优选的约为65mm，具有的第二部分的曲率半径在5.5至9.5mm的范围内，优选的约为7.5mm。在图示的实施例中，膜状物532相对于衬垫的面部接触平面所成角度在30至50°的范围内，优选的约为40°。
图72至76图示了衬垫610的另一个实施例。如图76最佳所示，衬垫至少包括基壁628和膜状物632。如图所示，鼻梁区域中的膜状物632的长度(例如膜状物的横截面长度)可改变。例如，鼻梁区域内的膜状物长度可选定为较短长度L1或较长长度L2。
如图74和75所示，当佩戴在患者面部时，膜状物长度控制移位的衬垫膜状物在患者的鼻子上滑动的距离(由患者面部轮廓上的虚线表示)。这个结构避免了任何过多的衬垫膜状物在患者的鼻子上过多下滑的可能性(例如，特别是鼻梁深度较浅的患者)，这将导致患者鼻子处的面部不适和皮肤印记。
图77至83图示了衬垫810的另一个实施例。衬垫810包括基壁828、下支撑衬垫830和膜状物832。如上所述，优选地，下衬垫830仅设置在衬垫810的横侧。
基壁828可相对于最外衬垫点，例如膜状物或下衬垫的外表面，向内偏移。这个结构提供了可环绕衬垫周长改变的弹簧特性，以改变环绕衬垫周长的衬垫柔性(横向和/或垂直)，例如衬垫硬度可在每个衬垫区域内变化，以适应每个区域中的密封需要，密封需要可因为患者的下面部结构而改变。即如果有偏差(例如从“坚固”到“柔软”)沿衬垫侧面的水平可改变。
例如，图77至83图示了穿过衬垫810中的三个不同区域R1、R2、R3的横截面，如图81所示，基壁828、下衬垫830和膜状物832共同限定出相对直的外表面880。这在区域R1中提供最小弹性部件，例如硬性或刚性。
如图82所示，基壁828、下衬垫830和膜状物832共同限定出外表面882，该外表面从相对直的结构过渡到弯曲的结构。与区域R1相比，这为更大柔性的弹性部件提供了相对小的偏移。
如图83所示，基壁828、下衬垫830和膜状物832共同限定出外表面884，该外表面从基壁828向外弯曲。这为区域R3中的最佳弹性部件提供了相对大的偏移，例如柔韧或柔性特性。
因此，衬垫810可设计为提供环绕其周长的不同的柔性，这使衬垫810符合多种脸型。
图84至90图示了衬垫910的另一个实施例。衬垫910包括基壁928下支撑衬垫930以及膜状物932。如图所示，优选地，下衬垫930仅设置在衬垫910的横侧，例如，在鼻梁和下巴区域没有下衬垫(见图88)。
如图90所示，与图89相比，基壁928包括锥形部分990，该锥形部分朝膜状物932逐渐变细。这个结构可提高可塑性。
图91图示了图34A中衬垫10的选择性结构(图34A中虚线表示的结构)。如图所示，材料从侧壁28去除，并且空间或空隙34相对于图34A中的结构减小。图91的这个结构增加了相对于图34A中先前位移的位移。所增加的位移通过改变侧壁28的几何形状实现。值得注意的是，空隙34环绕衬垫周长是可变的或恒定的。
图92图示了图34A中衬垫10的选择性结构(图34A中虚线表示的结构)。如图所示，一些材料从侧壁28去除，并且空间或空隙34相对于图34A中的结构减小。图92的这个结构增加了相对于图34A中先前位移的位移。所增加的位移通过改变侧壁28的几何形状实现。这个结构可能需要基壁28的横截面加厚，以增加环绕衬垫周长的硬度或局部的硬度。当需要时，变硬可通过局部的助条实现。
图93图示了图15所示衬垫10的选择性结构。如图所示，锁眼形的切除部分(用于容纳患者的鼻梁区域)可随着面罩尺寸减小而变大。例如，非常小尺寸的面罩的切除部分大于大尺寸面罩。
值得注意的是，患者面部的特定区域的横截面设计(例如图23至29)可在环绕衬垫周长的特定区域或任何区域内。即横截面设计不应局限于特定区域。同样，图91和92所示的横截面可应用于环绕衬垫周长的任何点。
虽然参照目前被认为是最实用和最优选的实施例对本发明进行了描述，但是应该理解本发明不应局限于所公开的实施例，而是相反，本发明意图覆盖在本发明宗旨和范围内所包括的多种改进和等同结构。同样，上述的各种实施可结合其它实施例来实现，例如，一个实施例的方面可结合另一实施例的方面以实现又一实施例。此外，虽然本发明特别应用于遭受OSA的患者，但是应该意识到遭受其它疾病(例如，心脏充血失败，糖尿病，病态肥胖，打鼾，屏障(barriatric)手术等)的患者可受益于上述教导。此外，上述教导对非医疗应用中的患者和非患者等有适用性。

Claims (4)

1.一种用于为患者输送可呼吸气体的患者界面的衬垫，所述衬垫包括：
基壁，其被构造成与框架连接；
下支撑衬垫，其在使用中从所述基壁朝患者面部延伸；及
膜状物，其设置为基本覆盖下支撑衬垫的至少一部分，所述膜状物包括适于分别在患者面部的鼻梁、面颊和下巴区域形成连续密封的鼻梁、面颊和下巴区域，鼻梁和相邻的两个面颊区域限定有交叉处，
其中所述鼻梁区域的膜状物在交叉处的高度大于面颊区域的与鼻梁区域相邻的部分的高度。
2.如权利要求1所述的衬垫，其中所述鼻梁区域的膜状物具有滚压边缘。
3.如权利要求1至2中任一项所述的衬垫，其中在交叉处的顶点测量所述在交叉处的高度。
4.如权利要求1至2中任一项所述的衬垫，其中下支撑衬垫仅设置在膜状物的面颊区域的基壁的横侧。
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