CN103143098B - 呼吸面罩的前额衬垫 - Google Patents

呼吸面罩的前额衬垫 Download PDF

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CN103143098B
CN103143098B CN201310032494.7A CN201310032494A CN103143098B CN 103143098 B CN103143098 B CN 103143098B CN 201310032494 A CN201310032494 A CN 201310032494A CN 103143098 B CN103143098 B CN 103143098B
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support
support column
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head
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CN103143098A (zh
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贝恩德·克里斯托夫·朗
蒂莫西·俊晖·付
佩里·戴维·利思戈
梅姆杜赫·居内伊
乔安妮·伊丽莎白·德鲁
梅尔廷·贝希特尔
阿希姆·比纳
迈克尔·卡西皮拉·古纳拉特南
阿龙·塞缪尔·戴维森
米林·钱德拉坎特·拉热
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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
    • A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
    • A61M16/0644—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
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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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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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
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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
    • A61M16/0633—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
    • A61M16/06—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
    • A61M16/0638—Means for improving the adaptation of the mask to the patient with forehead support in the form of a pivot
    • 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
    • A61M16/0644—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
    • A61M16/065—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position in the form of a pivot
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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
    • A61M16/0683—Holding devices therefor
    • 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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
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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
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0825—Joints or connectors with ball-sockets
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system

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Abstract

本发明公开了一种呼吸面罩的前额衬垫，其包括：（a）基座部分，其中该基座部分限定（ⅰ）第一表面，及（ⅱ）接触使用者前额的第二表面；（b）支撑柱，其中该支撑柱从该第一表面凸出并包括收缩成颈状的区域；及（c）头部，其适合将该支撑柱连接到呼吸面罩的前额支撑并且包括适于在该前额衬垫连接到该前额支撑上时接合该前额支撑内的孔的前表面的第一唇，其中该收缩成颈状的区域便于该前额衬垫与该前额支撑可释放地接合，并且该支撑柱是挠性的并且能够经得住将该头部装配到该前额支撑所需要的力。

Description

呼吸面罩的前额衬垫
本申请是申请号为201010620187.7、2003年9月5日、发明名称为“呼吸面罩的前额衬垫”的专利申请的分案申请。申请号为201010620187.7的专利申请是申请日为2003年9月5日、申请号为03821170.X（国际申请号为PCT/AU2003/001160）、发明名称为“呼吸面罩的前额衬垫”的专利申请的分案申请。
本申请要求于2002年11月8日提交的美国临时申请号60/424，696和2003年5月5日提交的美国临时申请号60/467,572，以及2002年9月6日提交的美国非临时申请号10/235,846的优先权，上述优先权依次要求于2001年9月7日提交的美国临时专利申请号60/317,486和2001年12月28日提交的美国临时专利申请号60/342,854的优先权。上述专利申请的全文通过引用而全部包括在此。
技术领域
本发明涉及前额衬垫。这些衬垫能和呼吸面罩一起使用，用于睡眠呼吸障碍（SDB）的非侵入式正压通风（NPPV）治疗。
背景技术
鼻式面罩通常在呼吸条件和睡眠紊乱的治疗中使用，通过将宜于吸入的气体流传送给使用者以帮助使用者呼吸或者为使用者提供治疗形式的气体以防止睡眠紊乱，譬如阻塞性睡眠呼吸暂停（OSA）。这些鼻式面罩典型地通过供给管线接收气体，该供给管线将该气体送到由面罩壁形成的小室内。
该面罩通常是半刚性的并具有与使用者的鼻子和/或嘴联系的面部。通常用带子将该面罩绑到使用者的头部。用足够的力对着脸拉动面罩来调节带子以在面罩和使用者的脸之间获得不漏气的密封。从而气体通过孔传送到面罩至使用者的鼻孔和/或嘴的。
使用该面罩出现的问题之一是为了使带子绷紧，面罩对着使用者的脸压缩并且可能过分用力地推在使用者的鼻子上。另外，该面罩可能在使用者的脸上移来移去。因此，面罩通常包含在面罩和使用者的头部之间产生附加接触点的前额支撑。该前额支撑通过防止面罩过于强烈地对着使用者的鼻子和/或面部区域推动而使得面罩的移动最小化及使得面罩的不舒适的压力点最小化。
前额支撑已经典型地在那里连接了一个柔软舒适的接触患者的（patient-contacting）前额衬垫。前额衬垫通常由柔软的材料譬如硅构成，与通常是刚性的前额支撑形成对比。美国专利号6,119,693中公开了现有的前额衬垫的一种形式，该专利中的全部内容通过引用在此包含。
现有的前额衬垫的问题是衬垫连接到前额支撑的机构。该衬垫必须以一种容易插入和移动的方式固定，而不是无意地移动。而且，与前额支撑/衬垫和面罩框架之间的相对接近无关，应该没有导致更多不舒适的在对面使用者的脸能接触到的锐利的边缘。
如图50到57所示，已知的前额衬垫的一种形式用在空中引航面罩上，由MPV，Truma，德国制造。该前额衬垫包括适合通过前额支撑的臂上的孔拉动的杆（stalk）。该衬垫还包括适合与从前额支撑的臂向后突出的两排三齿（tworowsofthreeteeth）相咬合的两排三槽。这种类型的前额衬垫的问题包括：（i）难于装配；（ii）难于移除；（iii）在夜晚可能移动并向患者前额露出尖齿；（iv）装配模糊使得难于知道什么时候其处于正确的位置；（v）其构造导致高压区位于牙齿之下；及（vi）当以一个角度摇动时在患者的前额出现一个棱（edge）。
现有的前额衬垫的另外的问题是它们能在使用者的前额上导致压力不均匀，导致不舒服和在脸上留下痕迹。例如，已知的前额衬垫的一种形式包括接触患者的表面和一对加固支柱（strut），如图16到17所示。在使用期间，该衬垫受控于压缩力，在加固支柱连接的区域内该压缩力能在接触患者的表面上导致压力点、线或波纹。这导致在使用者的前额上压力不均匀。使用现有的前额衬垫还导致使用者发汗。
已知形式的前额衬垫的另一个问题是用于将前额衬垫和前额支撑啮合的机构。如图18到20所示，该前额支撑包括一对适合与前额衬垫内的凹口（recess）可移动地啮合的刚性的L型钩子（catch）c。当前额支撑在使用时，如果衬垫不在适当的位置，那么就会出现一个问题：钩子可能紧靠使用者的前额。这会导致不舒服和在前额留下印记。
因此，在前额衬垫的现有技术中存在克服上述问题的需要。
发明内容
本发明的一个技术方案是针对一种具有前额支撑和前额衬垫的面罩组件，为使用者提供更多的舒适。
本发明的另一个技术方案是针对一种将接触压力分布在使用者的前额周围的前额衬垫。
本发明的另一个技术方案是针对一种允许宽范围移动的前额衬垫。
本发明的另一个技术方案是针对一种减少或避免使用者与前额衬垫边缘之间接触的前额衬垫。
本发明的另一个技术方案是针对一种获得没有受力高的局部区域的均匀压力分布的前额衬垫。
本发明的另一个技术方案是针对一种容易插入到前额支撑中并且足够灵活以容纳不同的前额大小和外形的范围的前额衬垫。
本发明的另一个技术方案是针对一种前额衬垫，其从支撑柱（supportpost）到基座区域平滑地成锥形，使得力线平滑地并且均匀地从支撑柱传送到基座区域，导致压力沿着使用者的前额均匀地分布。
本发明的另一个技术方案是针对一种用于呼吸面罩的前额支撑的前额衬垫，其包括连接到支撑柱的平板区域和包括前额支撑啮合机构的支撑柱。
本发明的另一个技术方案是针对一种与前额支撑相对容易啮合但相对难于分开的前额衬垫。
本发明的另一个技术方案是针对一种减少或避免使用者与前额支撑的边缘之间接触的前额衬垫。
本发明的另一个技术方案是针对一种前额衬垫，其包括接触使用者前额的基座部分、包括连接到基座部分的收缩成颈状区域（neckeddownregion）的支撑柱及适合于将该支撑柱连接到呼吸面罩的前额支撑的头部。
本发明的另一个技术方案是针对一种前额衬垫组件，其包括至少两个衬垫，各个衬垫包括接触使用者前额的基座部分、包括连接到该基座部分的收缩成颈状区域的支撑柱及适合于将该支撑柱连接到呼吸面罩的前额支撑的头部。该组件还包括至少一个连接临近基座部分的连接器。
本发明的其他的方案、特征和优点从下面结合附图的详细描述中将会变得很清楚，附图是本公开的一部分并通过举例的方式解释优选实施例的原理。
附图说明
图1是根据本发明的一个实施例的呼吸面罩和前额衬垫的立体图；
图2是图1中表示的前额支撑在没有面罩框架和衬垫的情况下的放大立体图；
图3是根据本发明的前额衬垫的一个实施例的立体图；
图4是根据本发明一个第二实施例的呼吸面罩和前额衬垫的立体图；
图5是根据本发明的前额衬垫的另一个实施例的立体图；
图6是包括一对前额衬垫的前额支撑和使用者前额的俯视图；
图7是表示凸起表面的前额衬垫的一个实施例的接触表面的立体图；
图8是表示中空外区（hollowedoutregion）的前额衬垫的一个实施例的横截面图；
图9是表示由挠性连接器连接的两个衬垫的前额衬垫组件的实施例的俯视图；
图10是表示与使用者接触的呼吸面罩内的前额衬垫的一个实施例的右视图；
图11是与前额支撑的一个实施例啮合的前额衬垫的一个实施例的横截面视图；
图12是与前额支撑的另一个实施例啮合的前额衬垫的另一个实施例的横截面视图；
图13是与前额支撑的另一个实施例啮合的前额衬垫的另一个实施例的横截面视图；
图14是与前额支撑的另一个实施例啮合的前额衬垫的另一个实施例的横截面视图；
图15是图14所示的前额支撑的实施例的俯视图；
图16是现有技术前额衬垫的横截面；
图17是图16中表示的前额衬垫在压缩状态下的横截面；
图18是现有技术前额衬垫的横截面；
图19是现有技术前额支撑的主视图；
图20是图19中表示的前额支撑的俯视图；
图21是根据本发明的前额衬垫的另一个实施例的侧视图；
图22是图21中所示的实施例的仰视图；
图23是图21中所示的实施例的俯视图；
图24是图21中所示的实施例的另一个侧视图；
图25是图24中所示的实施例沿着轴25-25的横截面图；
图26是图21中所示的实施例的立体图；
图27是根据本发明的前额支撑的另一个实施例的立体图；
图28是根据本发明的前额衬垫的另一个实施例的端视图（endview）；
图29是图28中所示的实施例的侧视图；
图30是图28中所示的实施例的立体图；
图31是图28中所示的实施例的俯视图；
图32是图9中所示的实施例的后视图；
图33是图32中所示的实施例的俯视图；
图34是图32中所示的实施例的主视图；
图35是图9中所示的实施例的端视图；
图36是图35中所示的实施例沿着轴36-36的横截面图；
图37是图35中所示的实施例的展开横截面图；
图38是根据本发明的前额衬垫的另一个实施例的后视图；
图39是图38中所示的实施例的俯视图；
图40是图38中所示的实施例沿着轴40-40的横截面图；
图41是图38中所示的实施例的主视图；
图42是图39中所示的实施例的端视图；
图43是图42中所示的实施例沿着轴43-43的横截面图；
图44是图42中所示的实施例的展开横截面图；
图45是根据本发明与前额支撑的一个实施例啮合的前额衬垫的一个实施例的横截面图；
图46是图45中所示的实施例的侧视图；
图47是根据本发明与前额支撑的另一个实施例啮合的前额衬垫的另一个实施例的横截面图；
图48是图47中所示的前额衬垫的实施例和前额支撑的实施例的俯视图；
图49是图47中所示的与前额支撑的实施例啮合的前额衬垫的实施例在中间的装配步骤过程中的俯视图；
图50是现有技术的前额衬垫的主视图；
图51是图50中所示的前额衬垫的俯视图；
图52是图50中所示的前额衬垫的仰视图；
图53是图50中所示的前额衬垫的左视图；
图54是现有技术的前额衬垫的俯视图；
图55是图55中所示的前额衬垫的立体图；
图56是现有技术的前额支撑的俯视图；
图57是现有技术前额支撑的主视图；
图58是根据本发明的前额衬垫的另一个实施例的俯视图；
图59是根据本发明的前额衬垫的另一个实施例的前立体图；
图60是图59中所示的前额衬垫的后立体图；
图61是图59中所示的前额衬垫沿着短轴的横截面图；
图62是图59中所示的前额衬垫沿着长轴的横截面图；
图63是根据本发明的前额衬垫的另一个实施例的立体图；
图64是根据本发明的前额衬垫的另一个实施例的横截面图；
图65是根据本发明的前额衬垫的另一个实施例的横截面图；
图66是根据本发明的前额衬垫的另一个实施例的横截面图；
图67是根据本发明的前额衬垫的另一个实施例的部分横截面图；
图68表示根据本发明的前额衬垫的一个实施例固定在第一方向上；
图69表示根据本发明的前额衬垫的一个实施例固定在第二方向上；
图70表示根据本发明的前额衬垫的一个实施例固定在第三方向上；
图71表示根据本发明的前额衬垫的一个实施例固定在第四方向上。
具体实施方式
图1表示呼吸面罩组件100的一个例子。该面罩组件包括框架部分101，前额支撑102，及前额衬垫300。该面罩适合于安全并舒适地固定到使用者的脸上。特别地，该面罩组件100包括掩盖使用者的鼻子和/或嘴的密封形成区域103和能连接排气管的包容开口（containsopening）104。空气或氧气通过开口104在正压下流动。
前额支撑102有利地譬如通过枢轴设备105连接到面罩组件100的框架部分101上，枢轴设备105能够进行调节以允许前额支撑102适应使用者的面部外形。前额支撑102优选地由热塑性材料制成。在图2中更详细的表示了前额支撑的一个实施例。
前额支撑102能构造成本质上直的或可以是弯曲的。本质上直的实施例在图2中表示。在前额支撑是弯曲的情况下，该曲率通常是遵循使用者前额的曲率。而这是最可能的结构，使用具有对应曲率或其任何组合的前额支撑是在本发明的范畴之内。
前额支撑102设有一个或多个开口。这些开口适合提供无数的用途，包括到面罩框架的连接点，到任何其他支撑表面的连接点，用于带子为使用者固定面罩的连接点201，用于前额衬垫的孔202。
在前额支撑102的优选实施例中，孔202设计成承受该前额衬垫300的头部的重量。孔202以允许使用者调整该前额衬垫300的方式安放在该前额支撑102的左右。孔202还设计成允许使用者将该前额衬垫300安全地连接到该前额支撑102。在一个优选实施例中，孔202设计成允许使用者将该前额衬垫300安全地并可翻转地连接到该前额支撑102上。
根据本发明的第一个实施例的前额衬垫300在图3中进行了详细的表示。该前额衬垫300包括接触使用者前额的基座部分305，连接到该基座部分的支撑柱301，及适合连接到该前额支撑102的头部302。在这个实施例中，该头部302是子弹形状或锥形形状，或另外的锥形。然而，可能是其它的形状，只要它们用于本发明的用途。
该基座部分305、支撑柱301及头部302可以是设计成彼此安装在一起的单独件。在一个实施例中，该基座部分305和该支撑柱301能构造成一体。在另一个实施例中，该支撑柱301和该头部302能构造成一体。在又一个实施例中，该基座部分305和该头部302能构造成没有支撑柱301。最后，在一个优选实施例中，该基座部分305、支撑柱301及头部302被一体地成型为一体。
图3所示的实施例包含在头部302的底部和支撑柱301的顶部之间的收缩成颈状的区域303。在一个优选的构造中，该前额衬垫适合于可释放地与前额支撑102啮合。该收缩成颈状的区域303的功能是使这个特征更容易。该收缩成颈状的区域303是这样的，其直径小于头部302的底部的直径。这导致头部302的底部和收缩成颈状的区域303之间的唇（lip）310和收缩成颈状区域303与支撑柱301之间的另一个唇311。
在一个优选实施例中，该收缩成颈状的区域303至少同前额支撑102内的孔202（图2）的长度一样长。衬垫300通过前额支撑102内的孔的第一末端200的插入导致头部302经过孔202并出现在第二末端210外。支撑柱301保持在孔202的第一末端200的一边，同时收缩成颈状的区域303占据至少是孔的长度。这个特征导致容易插入和紧密配合。
典型地，这个插入可以由使用者通过将轴向压力施加到衬垫300的基座部分305上来进行。虽然支撑柱是挠性的，但是它能经得住装配所需要的力。使用图3中描述的前额衬垫的实施例和图2中描述的前额支撑作为例子，当逆着孔202的第一末端200施加轴向压力时，头部302和唇310都变形，直到头部302和唇310到达孔202的第二末端210，于是唇310再次膨胀以啮合邻接孔202的前额支撑102的第一表面215。此外，唇311紧靠前额支撑102的第二表面205，以防止衬垫300的轴向移动。
衬垫的拆除通过在与用于插入施加的轴向力相反的方向上施加牵引力而发生的。当唇310脱离与孔202邻接的前额支撑102的第一表面215时，头部302和唇310再次变形。唇311脱离前额支撑102的第二表面205。头部302和唇310在脱离前额支撑200之后都恢复到它们的原始形状。
通过使用者的手指能施加压力并且不仅通过头部302经过孔202的第一表面215出现来表明衬垫300的成功插入而且典型地通过咔嗒声表明成功插入。视觉、声音及易于插入的结合对于具有有限体力和/或手指灵巧的老年人或其他体弱的使用者是有用的。产生的声音具有为使用者提供衬垫在黑暗中已经成功插入的知识的附加的益处。由于面罩在夜里使用这个事实，所以这个特征具有重要性。前额支撑102和前额衬垫300都是这样构造的，即衬垫300能在支撑102上的不同位置上放置，从而获得接触使用者的前额的不同位置。
对于制造基座、支撑柱及头部的各种方法对于本领域的技术人员来说都是周知的。制造的优选方法是通过喷射模塑法。
支撑柱301能从基座305中以角度α突出，该角度α是在支撑柱301和基座部分305之间的接触点处在到基座部分305的外表面的切线t之间定义的，这个角度α可以是大约90°，即，该支撑柱301从该基座部分305基本上直地向外延伸。图3表示前额衬垫300的实施例，其中角度α大约是90°。
图4表示呼吸面罩组件410的另一个实施例。该面罩组件410包括框架部分411，前额支撑412及前额衬垫400的另一个实施例。该前额支撑412有利地譬如通过枢轴设备413连接到面罩410的框架部分411。该面罩组件410包括掩盖使用者的鼻子和/或嘴的密封形成垫414并包含旋转弯头415。该旋转弯头415适合接收在正压流动的空气或氧气供应。
图5更详细地表示了前额衬垫400的另一个实施例。衬垫400的这个实施例包括基座部分408、支撑柱401及头部402。该常规的构造和操作与第一实施例的相似，虽然在构造上有几个不同之处，譬如在支撑柱401和基座部分408之间的接触点处切线t到基座部分406的外表面的角度β是在大约60°和大约120°之间。优选地，角度β是大约70°。支撑柱401以小于90°的角度突出的一个优点是允许基座部分400更好地适合使用者的前额轮廓，如图6所示。
支撑柱401能以一种使其更灵活的方式构造。例如，支撑柱401包括切掉部分405。这些切掉部分帮助支撑柱能弯曲或折曲，改变使用角度β。以这种方式，如图68到71所示，在始终保持挠性度时较大直径的支撑柱401可以使用。
基座部分408可以是任何形状，优选地为类似衬垫构造。在一个实施例中，基座部分408的接触区域407具有使得接触力传递到使用者前额的表面在生理学上的相容压力下发生的形状，如图58所示。在一个优选实施例中，接触区域407凹向弯曲以与前额的曲率一致。
如图7所示，接触区域407能任选地包括凸起的表面图案510。图案510减少衬垫400的吸气作用的可能性，从而在区域内减少抽血并使得衬垫400更舒适。凸起的图案510具有减少发汗的附加的益处。在另一个实施例中，对衬垫的后表面406进行喷砂磨光以改善通风并减少发汗的可能性。
如图8的横截面视图所示，衬垫400的基座部分408和支撑柱401还可以包括向基座部分408和/或支撑柱401内延伸预定距离601的中空外区608。在所示的实施例中，该中空外区608经过基座部分408进行延伸并且部分地延伸到支撑柱401内。这种结构将弹性度和挠性度赋予前额衬垫400。由于硅酮的基本上不可压缩的特性，一些切掉区域405协助伸缩。中空外区608的使用对通过支撑柱401沿着轴的一些移动留有余地。
增加支撑柱401的直径使得前额衬垫400容易插入到前额支撑102中。此外，较大的直径减少了压力点限于局部的可能性。然而，当支撑柱401制作得较厚时，其变得柔韧性小了。因此本发明的优选实施例用柔韧性对容易插入进行平衡。
在另一个实施例中，中空外区608通过基座部分408、支撑柱401和头部402延伸，构成直通钻孔509（如图7所示）。该直通钻孔509还有助于在装配和拆卸过程中支撑柱401和头部402的压缩。这个结构允许从使用者的皮肤到大气之间出现空气和/或湿气流，导致发汗的减少和更舒适的衬垫400。
该支撑柱401具有大约0.1cm和大约3.0cm之间的最宽方面内的直径。尤其特殊地，图9的实施例的支撑柱的直径是在大约0.5cm和大约1.25cm之间，并且优选地该直径是大约1cm。术语“大约”意味着暗示该直径不是绝对的而是可以由本领域的技术人员偏离。可选择的实施例，譬如那些图21到31中所表示的具有不同的直径。
支撑柱401具有大约0.1cm和大约2.5cm之间的最宽方面内的长度。尤其特殊地，该长度是在大约0.5cm和大约1.25cm之间，并且尤其优选地该长度大约是1cm。图37中表示了一种形式的前额衬垫的尺寸。再次，该术语“大约”意味着暗示该长度不是绝对的而是可以由本领域的技术人员偏离。
支撑柱401可以是直的或它可以是锥形的。直的支撑柱的一个例子表示在图3的实施例中。锥形还可以是这样，即基座部分的区域比头部区域厚，如图5中的实施例所示。
正如本领域的一个技术人员所能理解的，根据本发明可以使用各种材料制造该前额衬垫。所使用的任何材料的特征应该包括生物适应性，挠性和舒适。这些材料的一些例子包括橡胶和柔性塑料。在一个优选实施例中，衬垫由道尔科宁（DowCorning）制造的硫化的液体硅橡胶（硅橡胶94-595-HC，＃2666031部分）构成，可选择地，可以使用具有大约35-45肖氏A硬度的硅酮。这些例子仅仅是用来解释性的并且不局限于任何方式。
根据本发明的一个优选的实施例，至少两个底部衬垫（basepad）能加入道前额衬垫组件700中。在这个实施例中，其两种形式表示在图9和图32到44中，连接器711用来连接临近的基座部分708。可以使用任何类型的连接器，譬如带子或柔性桥部件。连接器的一个优点是组件700具有极少可能丢失的一体设计。该多个具有接触区域707的基座部分708和连接器711能彼此一体形成。
如前面所述，中空外区608能延伸到基座部分708和/或支撑柱701中预定的距离。这个距离可以调整以增大前额衬垫组件700的挠性。例如，当与图37中所示的实施例进行比较时，图44所示的实施例中中空外区608延伸到支撑柱701中更长的距离。增大该中空外区608的距离具有几个优点，包括挠性，与基座部分708的边缘接触最小化，及较好的气流使得使用者发汗减少。
该中空外区608还可以具有包括圆锥形、金字塔形、圆柱形或其组合的各种形状。该中空外区408在其内具有包括脊、隆起（bump）或洞的附加子结构。
在一个优选实施例中，为了位于使用者的左眉和右眉之上，前额衬垫组件700的两个基座部分708是合适的。如图10所示，表示基座部分708靠着使用者的前额813。该支撑柱701设计成沿着箭头814的方向用作弹簧。该切掉部分705在保持容易插入的同时提高了其柔韧性。这种设计的另一个优点是它能更好地适应面罩410的旋转和扭曲。支撑柱701的另外的优点是其直径被最优化以减少单个点的压力对前额813的影响。
该切掉部分705在该切掉部分705与基座部分708之间限定一个底切部720。该底切部720可以是包括曲线形，方形，圆锥形，三角形，或其任何组合的各种形状。该底切部720深度e也是可以改变的。深度e可以在大约0.25mm到大约1.25mm之间的范围内变化，优选地在大约0.5mm和大约1mm之间，更优选地为大约0.75mm。术语“大约”意味着暗示该宽度和长度不是绝对的而是可以由本领域的技术人员偏离的。
该切掉部分705的数量、形状、大小、宽度w及长度l可以改变以适合于各种用途，包括容易插入，容易脱除，当拆卸前额支撑时动作的灵活性，当装配前额支撑时动作的灵活性，使使用者与基座部分708的边缘之间的接触最小化，使使用者与前额支撑102之间的接触最小化，及前额衬垫组件700和前额支撑102之间的角度最小化。宽度w能在大约0.25mm到大约1.25mm之间的范围内变化，优选地在大约0.5mm与大约1mm之间，更优选地为大约0.75mm。长度l能在大约0.05mm到大约1.5mm之间变化，优选地在大约0.25mm和大约1mm之间。再次，术语“大约”意味着暗示该宽度和长度不是绝对的而是可以由本领域的技术人员偏离。
该切掉部分705可以具有相似的区域或不同的宽度w和相似的或不同的长度l。比较图32到37中所示的前额衬垫组件700的实施例与图38到44中所示的前额衬垫组件700的实施例表明对切掉部分705的几个改变。在图38到44所示实施例中切掉部分705的宽度w小于图32到37所示实施例中该切掉部分705的宽度w。
图40（沿着图39的线40-40的横截面图）中的底切部720可以比图32到37的实施例更显著。因此衬垫在垂直平面内的移动范围可以增大，从而增大面罩适合使用者的范围。此外，增大的移动范围能有助于防止衬垫的边缘与使用者的前额接触，从而增大使用者的顺应性和舒适。最后，增大的底切部720与切掉部分705周围的形状和大小一起能实现关于支撑柱701弯曲基座部分708所必需的力，从而在始终考虑到前额衬垫组件700的优良性能的同时，在使用者可接受的程度内优化期望的挠曲力。
减少宽度w和/或增加深度e的一个优点是改变前额衬垫组件700和前额支撑102之间的角度δ，其依次考虑了活动的更大范围和使用者舒适。角度δ是水平线h和经过基座708与支撑柱701的中心的线之间的角度。图45和46表示图38到44中所示装配有前额支撑102的前额衬垫组件700的实施例。角度δ大约是25°。图32到37中所示的装配有前额支撑102的前额衬垫组件700的实施例的角度δ大约是0°。再次，术语“大约”意味着暗示角度不是绝对的而是可以由本领域的技术人员偏离。
在通常平行于使用者前额的角度的前额衬垫组件700的基座部分708的外观为使用者提供了改良的舒适，减少了由不均匀的外观导致的压痛的可能性。在长面罩的一些形式中，例如全面罩，在使用中前额支撑102可以位于使用者前额的比护鼻面罩高的位置。
在图42所示的前额支撑的实施例中，当从一个末端看过去时，支撑柱701和基座部分708通常彼此垂直。然而，在另一个实施例中，它们可以构造成不同的角度。对于一个长面罩，因为头骨的曲率，为了使前额衬垫组件700的基座部分708呈现通常地平行于使用者的前额，或者（i）前额支撑102应该适合保持以一个角度垂直前额衬垫组件700，如图45所示，或（ii）前额支撑102应该适合保持以一个直角非垂直前额衬垫组件700。在该优选实施例中，使用垂直衬垫并且该前额支撑102适合保持并将该衬垫以合适的角度呈现给使用者的前额。以这种方式，相同的前额衬垫组件700能在面罩系统范围内使用，例如，鼻式面罩和全面罩，通过使用常规件为制造商提供经济效益。
图11表示插入到前额支撑940的孔930内的前额衬垫900的实施例的横截面。为了插入衬垫900，在箭头914的方向上施加轴向力。当头部902和唇904经过孔930时变形。一旦头部902和唇904经过孔930，则支撑柱901的收缩成颈状的区域903占据孔930的长度。这导致唇905也与前额支撑940接触。唇904和905与前额支撑940的各个侧面的啮合导致保持衬垫900在适当的位置。
为了从前额支撑940移开衬垫900，在箭头914相反的方向上拉动衬垫900。再一次，当头部902和/或唇904经过孔930时弯曲，使得衬垫900能从前额支撑940上脱离。
图12表示插入到前额支撑1040的另一个实施例中的前额衬垫408的一个实施例的横截面。该前额支撑1040具有当压力从方向a施加到衬垫408上时能以方向d移动的臂2000。在一个实施例中，臂2000的移动导致塑料变形，即，衬垫408的移除（removal）导致臂2000基本保持在衬垫408插入时它们的位置。在另一个实施例中，臂2000的移动导致弹性变形，即，衬垫408的移除导致臂2000基本上返回到衬垫408插入前它们的位置。考虑到容易插入和移除但始终提供固定结合，支撑柱401能在方向b上压缩。一旦插入，衬垫408能按照角度γ调节。
图13中表示了啮合了刚性前额支撑1040的前额衬垫1000的另一个实施例的横截面。该前额支撑1040包括唇1042和1043。前额支撑1040的唇1042适合啮合头部1002的唇1004并且支撑柱1040的唇1043适合啮合支撑柱1010的唇1005。在本发明的另一个实施例中，支撑柱1010被共同成型为前额支撑1040。
图14和15表示与前额支撑1040的一个实施例啮合的前额衬垫100的另一个实施例。该前额支撑1040具有臂2001。这些臂2001限定孔1030并能在方向a上移动以容许衬垫1000移除（removal）。
在本发明的另一个实施例中，支撑柱1010包括通常适合与前额支撑的钥匙形槽啮合的圆柱末端区域。为了将杆连接到前额支撑上，末端区域的小直径部分经过通常小直径的矩形区域滑动，在具有直径略于杆直径的圆柱形区域内接收到之前，使其变形，如图47到49所示。该末端区域的较小直径部分限定两个肩部区域，在功能上与那些其他的实施例相似，适合防止衬垫的轴向运动。
在一种形式中，前额衬垫的基座部分408通常是板形或盘形。在一个优选的形式中，在使用中它通常给患者的前额呈现凹面。基座部分的可能形状包括矩形和椭圆形。
支撑柱401和基座区域408的形状设计成使得力线490平滑地并均匀地从支撑柱401传送给基座区域408，如图58所示。以这种方式，压力均匀分布在使用者的前额813上。力线490不集中于一点。支撑柱410属于足够刚硬以致于当插入和推进时不会变弯的设计。
根据本发明的前额衬垫的可选择的实施例在图59到62中表示。在这个实施例中，在前额支撑的丁字架臂上有一个“夹板”，该夹板通常具有椭圆形状并位于远离前额支撑的臂表面，确定夹板的前侧和前额支撑的臂之间的空间。衬垫通常具有定义长轴和短轴的椭圆形并包括具有可变轮廓的轴。初始轮廓属于对夹板的补充形状，允许衬垫固定在夹板上。更进一步地沿着该轴，该轮廓旋转大约90°，确定肩部区域。以这种方式，衬垫能插入到夹板上然后扭曲大约90°以将其锁定在适当的位置上。在这个位置上，衬垫的肩部区域与夹板的前侧啮合。
在一个优选实施例中，衬垫包括一对适合与前额支撑的臂上相应的突起相啮合的凹座。在凹座和各个突起之间的啮合为使用者提供关于衬垫已经正确地旋转地对准的反馈。而且，凹座和突起之间的啮合减少了无心的衬垫旋转移动。可供选择的闭锁机构，譬如那些钥匙或可滑动的滑雪块，落在本发明的范畴内。
图63表示本发明可供选择的实施例。在这个实施例中，前额支撑的臂通常是圆柱形并通常以泡沫的圆柱形“管子”覆盖，形成前额衬垫400。不管支撑相对于前额的角度，因为通常前额臂和管道的半径恒定，所以没有给使用者的前额呈现锐利的边缘。在一种形式中，泡沫仅仅部分地围绕该前额支撑的臂。而且，因为通常关于角位置泡沫的特性恒定，所以力线平滑地传送到使用者的前额。在另一个实施例中，管子构成某种形状，使得其外表面的较厚部分放置在前额并且经过管道的孔不需要是圆形，允许连接到非圆形臂。
图64到66所示的可供选择的实施例中，在圆周附近的管子的厚度可以改变以提供适应性。该管子能具有两个不同厚度的部分（图64），三个不同厚度的部分（图65），或能具有偏心的厚度（图66）。这些实施例提供几个其他的优点，包括在不移掉面罩的情况下增加舒适，减少管子的紧固及在不移掉面罩情况下有关的症状，譬如，发汗和不舒服。
图67表示本发明的可供选择的实施例。在这个实施例中，前额支撑102的尖端通常包括球状物。通常还呈球状形状的泡沫或硅酮衬垫400放置在前额支撑102之上。该通常球形的形状平滑地将力线从前额支撑的尖端传送到前额，而不管方向如何。以这种方式，在使用者的前额上力均匀分配。
当本申请已经描述了前额衬垫和前额支撑的几个实施例时，一个本领域的技术人员很好地理解了各种前额衬垫，前额支撑和面罩能可交替地使用。前额衬垫的类型不局限于特殊的前额支撑或特定面罩。
在可供选择的实施例中，前额衬垫的支撑柱能与譬如在MIRAGE面罩上使用的压出的衬垫相结合使用（美国专利号6,119,693）。另一个实施例具有缺少凹面的前额衬垫，改为包括在与凹面结合使用的支撑柱。另一个实施例包括具有改变横截面厚度的衬垫，譬如，它应该在边缘比中心更薄，用于在旋转时的更大灵活性。
因而能意识到本发明的技术方案已经完全和有效地实现。前述具体实施例已经提供来说明本发明的结构上和功能上的原理，并不局限于此，相反，本发明旨在包括所有在详细的描述的宗旨和范畴内的修改、改变和替换。

Claims (46)

1.一种前额衬垫，包括：
(a)基座部分，其中该基座部分限定
(ⅰ)第一表面，及
(ⅱ)接触使用者前额的第二表面；
(b)支撑柱，其中该支撑柱从该第一表面凸出并包括收缩成颈状的区域和限定相邻的底切部的切掉部分；及
(c)头部，其适合将该支撑柱连接到呼吸面罩的前额支撑并且包括适于在该前额衬垫连接到该前额支撑上时接合该前额支撑内的孔的前表面的第一唇，其中
该收缩成颈状的区域便于该前额衬垫与该前额支撑可释放地接合，并且
该支撑柱具有挠性和对将该头部插入该前额支撑中的孔以及将该头部装配到该前额支撑所需要的轴向力的抗性，所述挠性和对轴向力的所述抗性为所述切掉部分的大小和形状连同所述相邻的底切部的范围的作用。
2.根据权利要求1所述的前额衬垫，其中，该支撑柱具有从该基座部分朝向该头部减小的大致成锥形的外形。
3.根据权利要求1所述的前额衬垫，其中，当轴向压力施加到该前额支撑内的孔的第一末端时，该头部和第一唇都变形，直到该头部和第一唇到达该前额支撑内的孔的第二末端。
4.根据权利要求3所述的前额衬垫，其中，该头部经过该前额支撑内的孔露出时产生咔嗒声。
5.根据权利要求1所述的前额衬垫，其中，该切掉部分具有使得该支撑柱从支撑区域的部分以一角度突出的变化的长度。
6.根据权利要求1所述的前额衬垫，其中，该收缩成颈状的区域的直径比头部的底部直径小。
7.根据权利要求1所述的前额衬垫，其中，在该支撑柱的轴线和在该支撑柱与基座部分之间的接触点处第一表面的切线之间定义的角度在60°和120°之间。
8.根据权利要求1所述的前额衬垫，其中，该支撑柱轴向可压缩。
9.根据权利要求1所述的前额衬垫，其中，该支撑柱设计为用作弹簧。
10.根据权利要求1所述的前额衬垫，其中，中空外区经过基座部分进行延伸。
11.根据权利要求10所述的前额衬垫，其中，该中空外区至少部分地延伸到该支撑柱内。
12.根据权利要求1所述的前额衬垫，其中，中空外区至少部分地延伸到该支撑柱内。
13.根据权利要求12所述的前额衬垫，其中，该中空外区将弹性度和挠性度赋予前额衬垫。
14.根据权利要求1所述的前额衬垫，其中，基座部分成形为衬垫构造。
15.根据权利要求14所述的前额衬垫，其中，基座部分的接触区域凹向弯曲以与前额的曲率一致。
16.根据权利要求15所述的前额衬垫，其中，基座部分包括凸起的表面图案。
17.根据权利要求16所述的前额衬垫，其中，对基座部分的后表面进行喷砂磨光。
18.根据权利要求1所述的前额衬垫，其中，该头部具有易于插入该前额支撑的孔内的子弹形状或锥形形状。
19.一种前额衬垫组件，其包括由柔性桥部件连接的两个根据权利要求1至18中任一项所述的前额衬垫。
20.根据权利要求19所述的前额衬垫组件，其中，该前额衬垫组件被整体地成型为一体。
21.一种前额衬垫，包括：
a)基座部分，其中该基座部分限定
(i)第一表面，及
(ii)接触使用者前额的第二表面；
b)支撑柱，其中该支撑柱从该第一表面凸出并包括收缩成颈状的区域和限定相邻的底切部的切掉部分；及
c)适合将该支撑柱连接到呼吸面罩的前额支撑的头部，其中该收缩成颈状的区域便于该前额衬垫与该前额支撑可释放地接合，
其中该基座部分进一步包括中空外区，该中空外区经过该基座部分进行延伸并且至少部分地延伸到所述支撑柱内，
该头部进一步包括适于在该前额衬垫连接到该前额支撑上时接合该前额支撑内的孔的前表面的第一唇，并且
其中，该支撑柱具有挠性和对将该头部插入该前额支撑中的孔以及将该头部装配到该前额支撑所需要的轴向力的抗性，所述挠性和对轴向力的所述抗性为所述切掉部分的大小和形状连同所述相邻的底切部的范围的作用。
22.根据权利要求21所述的前额衬垫，其中，该支撑柱具有从该基座部分朝向该头部减小的大致成锥形的外形。
23.根据权利要求21所述的前额衬垫，其中，当轴向压力施加到该前额支撑内的孔的第一末端时，该头部和第一唇都变形，直到该头部和第一唇到达该前额支撑内的孔的第二末端。
24.根据权利要求23所述的前额衬垫，其中，该头部经过该前额支撑内的孔露出时产生咔嗒声。
25.根据权利要求21所述的前额衬垫，其中，该切掉部分具有使得该支撑柱从支撑区域的部分以一角度突出的变化的长度。
26.根据权利要求21所述的前额衬垫，其中，该切掉部分具有适于在该前额衬垫连接到该前额支撑上时接合该前额支撑内的孔的后表面的第二唇。
27.根据权利要求21所述的前额衬垫，其中，该收缩成颈状的区域的直径比头部的底部直径小。
28.根据权利要求21所述的前额衬垫，其中，在该支撑柱的轴线和在该支撑柱与基座部分之间的接触点处第一表面的切线之间定义的角度在60°和120°之间。
29.根据权利要求28所述的前额衬垫，其中，该切掉部分具有适于在该前额衬垫连接到该前额支撑上时接合该前额支撑内的孔的后表面的第二唇。
30.根据权利要求21所述的前额衬垫，其中，该支撑柱轴向可压缩。
31.根据权利要求21所述的前额衬垫，其中，该支撑柱设计为用作弹簧。
32.根据权利要求21所述的前额衬垫，其中，该基座部分成形为衬垫构造。
33.根据权利要求32所述的前额衬垫，其中，该基座部分的接触区域凹向弯曲以与前额的曲率一致。
34.根据权利要求33所述的前额衬垫，其中，基座部分包括凸起的表面图案。
35.根据权利要求34所述的前额衬垫，其中，对基座部分的后部分进行喷砂磨光。
36.根据权利要求21所述的前额衬垫，其中，该头部具有易于插入该前额支撑的孔内的子弹形状或锥形形状。
37.一种前额衬垫组件，其包括由柔性桥部件连接的两个根据权利要求21至36中任一项所述的前额衬垫。
38.根据权利要求37所述的前额衬垫组件，其中，该前额衬垫组件被整体地成型为一体。
39.一种前额衬垫，包括：
(i)基座部分，其适于以与患者的前额平行的角度呈现一表面；以及
(ii)支撑柱，其在纵向方向上足够地坚硬，以在将该前额衬垫组装到面罩系统期间承受施加到该基座部分的轴向压力，并且进一步包括限定相邻的底切部以利于该基座部分相对于该面罩系统弯曲的切掉部分，以使得该表面能够保持与患者的面部区域平行，所述支撑柱的弯曲范围和所述支撑柱的坚硬度为每个所述切掉部分的大小和形状连同每个所述相邻的底切部的范围的作用。
40.根据权利要求39所述的前额衬垫，其中，该支撑柱具有从该基座部分朝向适于将该支撑柱连接至该面罩系统的前额支撑的头部减小的大致成锥形的外形。
41.根据权利要求40所述的前额衬垫，其中，该头部进一步包括适于在该前额衬垫连接到该前额支撑上时接合该前额支撑内的孔的前表面的第一唇。
42.根据权利要求39所述的前额衬垫，其中，各个切掉部分均具有使得该支撑柱从支撑区域的部分以一角度突出的变化的长度。
43.根据权利要求41所述的前额衬垫，其中，各个切掉部分均具有适于在该前额衬垫连接到该前额支撑上时接合该前额支撑内的孔的后表面的第二唇。
44.根据权利要求43所述的前额衬垫，其中，该头部具有易于插入该前额支撑的孔内的子弹形状或锥形形状。
45.一种前额衬垫组件，其包括由柔性桥部件连接的两个根据权利要求39至44中任一项所述的前额衬垫。
46.根据权利要求45所述的前额衬垫组件，其中，该前额衬垫组件被整体地成型为一体。
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