CN109011081A - 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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CN109011081A
CN109011081A CN201810652985.4A CN201810652985A CN109011081A CN 109011081 A CN109011081 A CN 109011081A CN 201810652985 A CN201810652985 A CN 201810652985A CN 109011081 A CN109011081 A CN 109011081A
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liner
nose
region
patient
basal
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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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Priority to CN2006800021694A priority patent/CN101155610B/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0616Means 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
    • A61M16/0622Means 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057Pumps therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0616Means 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
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00Breathing 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
    • A62B18/08Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0611Means for improving the adaptation of the mask to the patient with a gusset portion
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture

Abstract

本发明公开了一种用于患者界面的衬垫,尤其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,其中所述下衬垫和/或基壁呈问号或镰刀形。

Description

用于患者界面的衬垫
[0001] 本申请是申请号为201110339739.1、申请日为2006年1月12日、发明名称为“用于 患者界面的衬垫”的专利申请的分案申请。申请号为201110339739.1的专利申请是申请号 为200680002169.4、申请日为2006年1月12日、发明名称为“用于患者界面的衬垫”的专利申 请的分案申请。
[0002] 相关申请的交叉参考
[0003] 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
[0004] 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
[0005] 采用NPPV治疗例如阻塞性睡眠呼吸暂停(OSA)的SDB,由SulIivan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。
[0006] 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。
[0007] 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。
[0008] 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。
[0009] 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
[0010] 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。
[0011] 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。
[0012] 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。
[0013] 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。
[0014] 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。
[0015] 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。
[0016] 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。
[0017] 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。
[0018] 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。
[0019] 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。
[0020] 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。
[0021] 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。
[0022] 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。
[0023] 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. Omm的范围内。
[0024] 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。
[0025] 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。
[0026] 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16_的弧长。
[0027] 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。
[0028] 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。
[0029] 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。
[0030] 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
[0031] 附图有利于本发明多个实施例的理解。在这些附图中:
[0032] 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;
[0033] 图10至14是图5中所示衬垫的横截面图;
[0034] 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;
[0035] 图16至17图不了图1至9中所不衬塾的另一种尺寸;
[0036] 图18至19图示了图1至9中所示衬垫的又一种尺寸;
[0037] 图20至21图示了图1至9中所示衬垫的再一种尺寸;
[0038] 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;
[0039] 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;
[0040] 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;
[0041] 图31至32是说明图1至9中所示衬垫的实施例和由ResMed Ltd.以IJ丨traMirage㊣ Full 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;
[0042] 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;
[0043] 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;
[0044] 图34B图示了由ResMed Ltd.以UlteiMirag:e®:Full Face为名称商业销售的已知 衬垫的弹性长度,并图示了 UltraMirage®Full Face的示例性尺寸;
[0045] 图35是图1至9中所示衬垫的侧视图;
[0046] 图36至37是图35中所示衬垫的横截面图;
[0047] 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;
[0048] 图38B是图示了图1至9中所示衬垫的实施例和由ResMed Ltd.以UltraMirage® 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;
[0049] 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;
[0050] 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;
[0051] 图46至53图示了由ResMed Ltd.以Ul_traMirage:®:Full Face为名称商业销售的已 知衬垫;
[0052] 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;
[0053] 图59至63是图54中所示衬垫的横截面图;
[0054] 图64是与由ResMed Ltd.以UltraMirage®:Full 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 UltraMirage®的相关部分可由虚线表示,即可能有其它不同部分未示出);
[0055]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;
[0056] 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;
[0057] 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;
[0058] 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;
[0059] 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;
[0060] 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;
[0061 ]图91图示了图34A中所示衬垫的选择性衬垫横截面;
[0062] 图92图示了图34A中所示衬垫的另一个选择性衬垫横截面;
[0063] 图93图示了图15中所示衬垫的选择性衬垫结构;
[0064] 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
[0065] 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
[0066] 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 Nasal Mask。衬垫10在使用 中提供患者面部的密封。
[0067] 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。
[0068] 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。
[0069] 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。
[0070] 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。
[0071] 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
[0072] 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I〇。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。
[0073] 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UltralViirage®Full 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UltralViirage®衬 垫 700〇
[0074] 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。
[0075] 基壁,下衬垫和膜状物
[0076] 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。
[0077] 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 夕卜,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。
[0078] 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。
[0079] 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。
[0080] 向内偏移的基壁和框架连接物
[0081] 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 1_1丨也1卜14培6^:讨垫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UltraMimge®衬垫700不同。
[0082] 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,OltraMirage®制·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。
[0083] 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。
[0084] 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C02再呼吸。
[0085] 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UltraMirage^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。
[0086] 可变弹黃常数(spring constant)
[0087] 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。
[0088] 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。
[0089] 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。
[0090] 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。
[0091] 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 〇
[0092] 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,wl可以是11.5mm,w2可以是8_。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,wl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。
[0093] 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。
[0094] 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wl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wl可以 是11.5_。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。
[0095] 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,rl可以是5mm,r2可以是7mm,t可以 是I · 5至2mm,b可以是3.5mm,且wl可以是11.5mm。在图28所示截面的实施例中,h可以是 16 · 5mm,rl可以是6至7謹,r2可以是8mm,t可以是1 · 5mm,b可以是3 · 5mm,且wl可以是11 · 5謹。 在图29所示截面的实施例中,h可以是17.5mm,rl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wl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。
[0096] 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。
[0097] 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。
[0098] 基壁和下衬垫的选择性实施例
[0099] 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 301中,下衬垫30大体呈T形。同样,在图30H和301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30 J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。
[0100] 下衬垫带来的位移
[0101] 当与UltraMirage®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 1 〇和UltraMirage®衬垫7 〇 〇之间力和位移的总体关系。如图所示,衬垫1 〇的曲线比 UltraMirage®衬垫7 0 0的指数型曲线平滑。因此,与UltraM—irage®衬垫7 0 0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。
[0102] 此外,如图31所示,衬垫10在点BlO完全压缩或开始回升的位移大于 UltraMirage®衬垫700在点B700开始回升的位移。此外,开始回升的点BlO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1 〇的该力的范围内的位移Al 〇的范围基本大于在用于UltmMtmge®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。
[0103] 图32图示了衬垫10和UilxaMirage㊣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IO的曲线的直线部分的坡度大于图31中衬垫IO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 UltraMirage⑩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。
[0104] 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。
[0105] 下衬垫的延伸的弹性长度
[0106] 图34A和34B图示了柔性下衬垫30的延伸长度,当与例如UkraMirage⑧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 LJItmMirage⑧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I 0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。
[0107] 鼻梁区域膜状物的结构
[0108] 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。
[0109] 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.Omm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,UltraMirage®^•垫700在这个区域相对平坦(见图52)。
[0110] 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. Omm范围内的曲率半 径,优选的约为4.0mm。 _1] 鼻梁区域的尖锐横截面轮廓
[0112] 如图10所示,鼻梁区域16中的膜状物32具有比UtoaMirage⑧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,UltmMirage_®•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。 _3] 鼻梁区域的平坦部分
[0114] 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。
[0115] 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。
[0116] 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I 〇在鼻梁区域16的位移可比约40mm大,例如 41mm。相反,UltraMirage®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)。
[0117] —些现有技术衬垫中鼻梁区域内衬垫的位移值如下:
[0118] ResMedTMActiva(B)Nasal Cushion —16mm
[0119] Respironics Comfort Full Face Cushion—26mm
[0120] ResMed Bubble Nasal Mask Cushion一43mm
[0121] Healthdyne Soft Series Nasal Mask Cushion—17mm
[0122] 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UltraA4irage®衬垫700相比,衬垫10提供了 更大柔性和/或范围更大的结构。
[0123] 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UltraMirage⑧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,UltraMirage®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 IJltraMi rage⑯衬垫700适应更大范围的鼻梁形状。
[0124] 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UltraMirage®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Pl延伸,这个平面Pl与限定框架连接物的平面P2成角度A。
[0125] 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。
[0126] 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。
[0127] 膜状物中的孔
[0128] 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—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.Omm的范围内,优选的为约3.0mm。
[0129] 使用中的衬垫的鼻梁区域的滚动动作
[0130] 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。
[0131] 选择性实施例
[0132] 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。
[0133] 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 UltraMirage®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 51 〇的横截面轮廓与intraMimge·衬垫700不同。
[0134] 例如,膜状物532连接到下衬垫530的位置比UltraMirage®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UltraMirage®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UltmMirage®付垫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UltraMirage®衬垫700相比时,衬垫510 的更长的长度a到b。
[0135] 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. Omm的范围内,优选的约为3.0_。
[0136] 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.Omm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. Omm的范围内, 优选的约为4.0mm。
[0137] 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。。
[0138] 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Ll或较长长度L2。
[0139] 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。
[0140] 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。
[0141] 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。
[0142] 例如,图77至83图示了穿过衬垫810中的三个不同区域Rl、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Rl中提供 最小弹性部件,例如硬性或刚性。
[0143] 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Rl相比,这为更大柔性的弹性部件提供了相对小 的偏移。
[0144] 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。
[0145] 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。
[0146] 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)。
[0147] 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。
[0148] 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。
[0149] 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。
[0150] 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。
[0151] 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。
[0152] 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 (54)

1. 一种用于为患者输送可呼吸气体的患者界面的衬垫,所述衬垫至少包括:鼻梁区域、 一对鼻翼区域、一对上面颊区域、一对下面颊区域以及下巴区域,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, 其中所述下衬垫和/或基壁呈镰刀形, 其中所述下衬垫具有与基壁的弹簧状连接,并且 其中所述膜状物形成衬垫的最宽点,并且所述基壁的底部相对于所述最宽点整体向内 偏移。
2. 根据权利要求1所述的衬垫,其中所述衬垫是全脸衬垫。
3. 根据权利要求2所述的衬垫,其中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。
4. 根据权利要求1至3中任一项所述的衬垫,其中所述下衬垫和/或基壁包括直线部分 和弯曲部分,并且所述直线部分具有延伸穿过所述弯曲部分的纵轴。
5. 根据权利要求1所述的衬垫,其中所述衬垫包括鼻梁区域、鼻翼区域、上面颊区域、下 面颊区域以及下巴区域。
6. 根据权利要求5所述的衬垫,其中所述下衬垫在所述衬垫的下巴区域被去掉。
7. 根据权利要求6所述的衬垫,其中在所述衬垫的下巴区域的至少一部分中所述膜状 物被允许朝向呼吸腔容易地挠曲。
8. 根据权利要求5至7中任一项所述的衬垫,其中所述下衬垫在上、下面颊区域的硬度 小于在所述衬垫的鼻翼区域的硬度。
9. 根据权利要求5至7中任一项所述的衬垫,其中所述下衬垫在下面颊区域的硬度小于 在所述衬垫的上面颊区域的硬度。
10. 根据权利要求1和5至7中任一项所述的衬垫,其中所述下衬垫和/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。
11. 根据权利要求1所述的衬垫,其中所述下衬垫的弹簧特性由下衬垫高度、下衬垫厚 度、下衬垫半径和下衬垫偏移量中的至少一项确定。
12. 根据权利要求1和5至7中任一项所述的衬垫,其中下衬垫和/或基壁限定了沿密封 长度变化的弹簧常数。
13. 根据权利要求1所述的衬垫,其中所述衬垫包括五个不同的区域,并且在所述五个 不同区域中至少三个的弹簧常数不同。
14. 根据权利要求1所述的衬垫,其中鼻梁区域中的膜状物构造为在使用中倒转,以容 纳具有鼻梁轮廓的范围的患者。
15. 根据权利要求1和14中任一项所述的衬垫,其中鼻梁区域中的膜状物弯曲部分的顶 点包括高于或齐平于相邻的两个面颊区域中的点⑻的点(A)。
16. 根据权利要求1和14中任一项所述的衬垫,其中所述衬垫的鼻梁区域中的膜状物包 括构造为倒转的倾斜侧部。
17. —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, 其中所述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。
18. 根据权利要求17所述的衬垫,其中所述膜状物包括五个不同的区域,并且在所述五 个不同区域中至少三个的弹簧常数不同。
19. 根据权利要求17和18中任一项所述的衬垫,其中所述衬垫是鼻衬垫。
20. 根据权利要求19所述的衬垫,其中所述膜状物包括适于分别在患者面部的鼻梁、鼻 翼和上嘴唇区域形成连续密封的鼻梁、鼻翼和上嘴唇区域。
21. —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, 其中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。
22. 根据权利要求21所述的衬垫,其中所述基壁内部偏移的深度在衬垫的不同区域是 不同的,并且所述深度至少部分确定了弹簧状特性。
23. 根据权利要求21和22中任一项所述的衬垫,其中所述衬垫是鼻衬垫。
24. 根据权利要求23所述的衬垫,其中所述膜状物包括适于分别在患者面部的鼻梁、鼻 翼和上嘴唇区域形成连续密封的鼻梁、鼻翼和上嘴唇区域。
25. —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, 其中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。
26. 根据权利要求25所述的衬垫,其中所述衬垫是鼻衬垫。
27. 根据权利要求26所述的衬垫,其中所述膜状物包括适于分别在患者面部的鼻梁、鼻 翼和上嘴唇区域形成连续密封的鼻梁、鼻翼和上嘴唇区域。
28. 根据权利要求25所述的衬垫,其中所述衬垫是全脸衬垫。
29. —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, 其中所述膜状物的内边缘限定了容纳患者的鼻子和嘴的孔,并且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。
30. 根据权利要求29所述的衬垫,其中所述嘴宽度对于所有衬垫尺寸均是恒定的。
31. 根据权利要求30所述的衬垫,其中所述嘴宽度对于所有衬垫尺寸均为60mm。
32. 根据权利要求29所述的衬垫,其中所述嘴宽度对于所有衬垫尺寸基本是恒定的。
33. —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, 其中下衬垫和/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。
34. 根据权利要求33所述的衬垫,其中所述衬垫是鼻衬垫。
35. 根据权利要求34所述的衬垫,其中所述膜状物包括适于分别在患者面部的鼻梁、鼻 翼和上嘴唇区域形成连续密封的鼻梁、鼻翼和上嘴唇区域。
36. 根据权利要求33所述的衬垫,其中所述衬垫是全脸衬垫。
37. —种设计一系列面罩组件的方法,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, 其中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。
38. —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, 其中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, 其中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. Omm的范围内。
39. 根据权利要求38所述的衬垫,其中所述衬垫是鼻衬垫。
40. 根据权利要求39所述的衬垫,其中所述膜状物包括适于分别在患者面部的鼻梁、鼻 翼和上嘴唇区域形成连续密封的鼻梁、鼻翼和上嘴唇区域。
41. 根据权利要求38所述的衬垫,其中所述衬垫是全脸衬垫。
42. —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, 其中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。
43. 根据权利要求42所述的衬垫,其中所述衬垫是鼻衬垫。
44. 根据权利要求43所述的衬垫,其中所述膜状物包括适于分别在患者面部的鼻梁、鼻 翼和上嘴唇区域形成连续密封的鼻梁、鼻翼和上嘴唇区域。
45. 根据权利要求42所述的衬垫,其中所述衬垫是全脸衬垫。
46. —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, 其中所述下衬垫具有的弧形结构包括大于16_的弧长。
47. 根据权利要求46所述的衬垫,其中所述弧长在16至30mm的范围内。
48. 根据权利要求46和47中任一项所述的衬垫,其中所述弧长在20至25mm的范围内。
49. 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, 其中所述膜状物包括沿所述密封的长度变化的厚度。
50. 根据权利要求49所述的衬垫,其中所述衬垫是鼻衬垫。
51. 根据权利要求50所述的衬垫,其中所述膜状物包括适于分别在患者面部的鼻梁、鼻 翼和上嘴唇区域形成连续密封的鼻梁、鼻翼和上嘴唇区域。
52. —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;及 膜状物,其适于在患者面部形成连续密封, 其中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。
53. 根据权利要求52所述的衬垫,其中所述锥形部分设置在鼻梁区域中。
54. 一种面罩系统,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。
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