CN101683546A - 鼻部组件 - Google Patents
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- CN101683546A CN101683546A CN200910160820A CN200910160820A CN101683546A CN 101683546 A CN101683546 A CN 101683546A CN 200910160820 A CN200910160820 A CN 200910160820A CN 200910160820 A CN200910160820 A CN 200910160820A CN 101683546 A CN101683546 A CN 101683546A
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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
- A61M16/0057—Pumps therefor
- A61M16/0066—Blowers or centrifugal pumps
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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
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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
- A61M16/0666—Nasal cannulas or tubing
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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
- A61M16/0683—Holding devices therefor
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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
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
- A61M16/0825—Joints or connectors with ball-sockets
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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
- A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
-
- 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
- A61M2210/06—Head
- A61M2210/0618—Nose
Abstract
本发明涉及一种用于将可吸入气体输送给患者的鼻部组件(600),所述鼻部组件(600)包括:具有主体的支架(616)及设置在主体的各个侧面上的侧支架元件;设置在支架(616)的主体上的患者接口;构造的将可吸入气体输送到支架(616)和患者接口用于患者呼吸的弯管(612),所述弯管(612)制成可移动地与各个所述侧面连接的结构;以及塞子(20,40,622,636)制成可移动地与支架(616)的各个所述侧面连接的结构,其中塞子(20,40,622,636)和弯管(612)的位置被构造成可选择性地互换。
Description
本申请是申请号为200580012190.8、申请日为2005年4月8日、发明名称为“鼻部组件”的专利申请的分案申请。
申请的交叉引用
[0001]本申请要求2004年4月9日提交的美国临时申请号为60/560,610以及2004年12月2日提交的美国临时申请号为60/632,193的利益,在此将所述申请的全部内容并入作为引用。
技术领域
[0002]本发明涉及用连续气道正压通气(CPAP)或无创正压通气(NPPV)治疗,例如睡眠呼吸障碍(SDB)的鼻部组件。
背景技术
[0003]一些用于治疗睡眠呼吸障碍的鼻部组件设计成插入患者的鼻孔。送风机提供的空气或其它适宜于吸入的气体通过柔软的管道进入鼻部组件。
[0004]鼻部组件通常包括相对硬的壳体,例如支架,以及一对管口(其可以为鼻垫、鼻叉、套管或鼻喷的形式),所述管口设置在硬壳体上并制成插入患者的鼻通道内的结构。管口通常使用帽盔组件使其保持原位,相对坚硬的壳体和帽盔组件使用某一形式的连接器连接在一起。
[0005]一种已知形式的鼻部组件在美国专利号为4,782,832的文献(Trimble等人)中描述。Trimble公开了一种鼻喷组件20,其包括适于靠近病人的鼻子佩戴的鼻喷22,以及适于戴在病人头部上方的头绑带组件24。该头绑带组件24设计成可操作地支撑靠近且部分地位于患者的鼻通道内的鼻喷22。
[0006]鼻喷22为通常Y型的刚性空心充气室28和一对侧部相互分开的鼻孔元件30的形式。通过可转动地将元件30安装于充气室28且将该元件30安装在可对该元件30相互进行选择侧面定位的槽中调整鼻孔元件30。而且,使用时可调整头绑带组件24以调节该鼻孔元件30的配合和密封。也就是,保持充分密封所需的力直接与保持所需的配合的力有关。因而,鼻部组件的配合或稳定性的调节直接影响该密封,其可不利地影响患者的舒适感。
[0007]其它的安装在硬壳体上的鼻垫或套管的例子在美国专利号为5,724,965和6,431,172的文献中公开。
[0008]由Viasys制造的鼻面罩组件,即Spiritus,包括具有一对靠近的或侧部分开的鼻孔元件的充气室。使用时头绑带组件与该充气室结合以调整该鼻孔元件的配合和密封。与Trimble类似,鼻部组件的配合或稳定性的调节直接影响密封,其可不利地影响病人的舒适感。
[0009]由InnoMed制造的鼻面罩组件,即Nasal Aire,包括具有一对靠近或侧部分开的鼻孔元件的充气室。该鼻孔元件构造成与病人鼻腔的粘膜表面或内通道结合以保持鼻面罩组件在病人面部上并提供密封。见,如美国专利号5,533,506。
[0010]由Stevenson Industries制造的鼻面罩组件(见美国专利6,012,455),即CPAP-Pro,包括牙齿固定器、平台以及具有鼻衬垫的供气管,其中该平台支撑供气管。牙齿固定器是一定尺寸的以啮合在病人口中的牙齿之间,以保持该组件在适当的位置。
[0011]公开号为WO00/13751的PCT申请公开了一种装置,其包括通过装配于病人牙齿的口承定位到与病人鼻子接合的气体输送部件。
[0012]例如上述讨论地现有的鼻部组件的普遍问题是患者舒适感。例如,由于朝向病人的鼻子拉动刚性的壳体和叉形物的帽盔组件施加的张力,叉形物会刺激患者的鼻子。
[0013]另一问题是实现与患者鼻通道密封配合,而不损失患者的舒适感。
[0014]另一问题是通过与叉形物,例如其边缘接触导致刺激患者鼻孔内部。
[0015]另一问题是通过从叉形物喷射的空气(空气流动刺激)导致刺激患者鼻孔内部。
[0016]另一问题是相对于患者的鼻子和/或头部调整鼻部组件,从而适应患者鼻子的各种形状和角度。
[0017]另一问题是密封和可以影响患者舒适感的稳定力之间的直接联系。
发明内容
[0018]本发明的一个方面是提供一种为患者提供更多舒适的鼻部组件。
[0019]本发明的另一方面是提供一种有效密封患者的鼻通道的鼻部组件。优选地,鼻部组件为一种包括管口的管口组件,其舒适地与鼻孔的外边缘接触并避开鼻通道敏感的内部通道(例如,黏膜表面或内部通道)。
[0020]本发明的另一方面是提供一种鼻部组件,其不依赖于帽盔组件的张力而在管口和患者的鼻通道之间提供有效的密封。
[0021]本发明的另一方面是提供一种不突出的鼻部组件。
[0022]本发明的另一方面是提供一种易于使用的鼻部组件。
[0023]本发明的另一方面是提供一种保持帽盔调整设置的鼻部组件。
[0024]本发明的另一方面是提供具有构造的以提供性能增强的剖面的通气口。
[0025]本发明的另一方面是提供一种有助于消除密封和稳定力之间相互影响的鼻部组件。特别的是,本发明的一个方面是提供一种鼻部组件,所述鼻部组件这样构造,以致于发挥作用以使鼻部组件保持在患者面部上的稳定力与密封力分开或至少更好的区别开,所述密封力发挥作用以保持鼻部组件和患者面部之间的密封。
[0026]本发明的另一方面是提供一种鼻部组件,其为鼻部组件的管口提供更大范围的运动。
[0027]本发明的另一方面是提供一种向患者输送可吸入的气体的鼻部组件。所述鼻部组件包括具有主体的支架和设置在主体的每个侧面上的侧支架元件,每个侧支架元件包括整体成形的第一连接器部分。管口组件包括撑板或底部以及一对管口。管口组件与支架的主体连接,所述支架具有制成与使用中的患者鼻子的鼻通道密封结合的结构的一对管口。一对入口管道制成将可吸入气体输送到支架和管口组件以用于患者呼吸的结构。一对第二连接器部分可移动地并可旋转地连接到支架的各自的第一连接器部分。第二连接器部分通过角连接器与入口管道连通。帽盔组件可移动地连接到第二连接器部分和角连接器中的至少一个上,以致使支架和管口组件保持在患者面部期望的调整位置上。
[0028]根据本发明的另一方面,将可吸入气体输送给患者的鼻部组件包括具有主体的支架和设置在主体每个侧面上的侧支架元件;设置于支架的主体上的患者接口;构造的将可吸入气体输送到支架和患者接口用于患者呼吸的弯管,弯管构造成可移动地与支架的每个侧面连接;塞子构造成可移动地与支架的每个侧面连接。塞子和弯管的位置可选择性地互换。
[0029]另一方面是提供一种包括设置在支架上的挡板的鼻部组件。
[0030]本发明的另一方面是提供一种包括设置在支架上、允许排出呼出的气体的通气口的鼻部组件。
[0031]通过下面结合作为说明书一部分并通过实施例阐明本发明的原理的附图进行详细描述,本发明的其它方面、特征和优势将变得显而易见。
附图说明
[0032]附图使得理解本发明的各种实施方案变得容易。在所述附图中:
[0033]图1是鼻部组件另一实施方案的透视图;
[0034]图2是阐明图1所示鼻部组件的一部分的轴侧图;
[0035]图3是根据本发明的鼻部组件的一部分的横截面视图;
[0036]图4和5是根据本发明的通气孔的横截面视图;
[0037]图6是图3左手侧的局部放大横截面视图;
[0038]图7是图3右手侧的局部放大横截面视图;
[0039]图8是显示根据本发明一种实施方案的密封环和弯管旋转之间的接口的分解透视图;
[0040]图9是图1所示的面罩组件的一部分的部分横截面视图;
[0041]图10阐明本发明的有整体的塞子和密封组件的另一种实施方案;
[0042]图11和12阐明根据本发明一种实施方案的管定位器;
[0043]图13阐明根据本发明一种实施方案的另一种管定位器;
[0044]图14-18阐明根据本发明一种实施方案的另一种管定位器;
[0045]图19-31阐明本发明另一种实施方案;
[0046]图32-35阐明本发明另一种实施方案;
[0047]图36-41阐明根据本发明一种实施方案的塞子;
[0048]图42阐明根据本发明一种实施方案的通气口;
[0049]图43-45A和45C-45H阐明根据本发明另一实施方案的通气口;
[0050]图45B阐明现有技术的通气口;
[0051]图46-48阐明根据本发明实施方案的挡板;
[0052]图49-51阐明根据本发明一种实施方案的另一种旋转弯管;
[0053]图52-54阐明根据本发明一种实施方案的支架;以及
[0054]图55-58阐明本发明另一可选择的实施方案。
具体实施方式
[0055]下面包括本发明几个举例的实施方案的描述。每个举例的实施方案包括可以以其它实施方案的方式使用和/或用于其它实施方案的特征,或以美国非临时申请10/781,929中描述的实施方案和/或部件的方式使用的特征,这对本领域普通技术人员来说是显而易见的。
[0056]图1-13阐明了本发明的另一种优选的实施方案。如图1所示,面罩组件600包括帽盔602和衬垫组件604。帽盔602设计成抓住患者头的顶部。通过在相反的方向拉动在头顶上的松散的突出物603可以调整绑带的张力。拉动的方向不和管口组件施加于患者的力成一直线。因此,患者更加与绑带的调整力隔离。轭状物608对侧面提供稳定性。轭状物608保持至少一部分帽盔的基本形状,帮助戴上帽盔。由于所有帽盔的调节装置可能会在头的后部或顶部受影响,因此帽盔不需要包括朝脸前部的调节性。
[0057]在图1的实施方案中,衬垫组件604的一端设置有塞子622,另一端设置有旋转弯管612。根据优选,例如患者典型的睡眠位置,旋转弯管612和塞子622的位置可以互换。空气输送管606连接到旋转弯管612上。空气输送管606可以包括旋转连接器607,并且包括也可以设置旋转连接器的末端609。末端609提供加压气体源。
[0058]如图1所示,弯管612从衬垫组件604转动大约120°。这有助于保持所述管离开视线、使压力下降减少到最低限度并且保持管的弯曲部分尽可能靠近脸部。然而,如例如图2和3所示,弯管具有典型地90°的弯曲。
[0059]图2是图1所示面罩组件600的示意透视图,但是只显示了帽盔602的轭状物608,没有显示绑带,例如904等。轭状物608可包括轭环610。如图2所示,衬垫组件可关于帽盔调整旋转至最适合患者的位置。在图2中,帽盔的轭状物608的环610包括对准标记611a,衬垫包括多个对准标记611b,所述对准标记611b可选择地与标记611a对准。
[0060]图3是部分衬垫组件604的横截面视图。特别是,衬垫组件604包括支撑衬垫617的支架616。支架616包括设置在支架616和/或衬垫617各端上的第一连接器部分618。每个第一连接器部分618提供或提供到密封环614。密封环和塞子为第二连接部分的实例,其连接或设置到第一连接器部分618上。如图3所示,面罩组件的左手侧包括塞子622,而面罩组件的右手侧包括旋转弯管612,即图1和2所示的相对设置图。
[0061]图3显示衬垫617包括多个通气孔619,每一个被设计成减少噪音。图4和5显示两个可能的孔剖面的横截面视图。在图5中,末端617a使产生闪点的任何潜在的噪音(即,模制接缝)通过通气孔离开主空气通道。另一种说法,模制接缝从其可能潜在产生噪音的位置移动到较少可能产生噪音的位置。
[0062]图6是显示密封环614、第一连接器部分618和塞子622之间的相互作用的部分横截面视图。特别的,密封环614可以分别设置第一和第二突起624,626。第一突起624可以与设置在第一连接器618内的凹槽618a相互作用,用于密封和/或锁定的目的。第二突起626可以与设置在塞子622内的凹槽628相互作用,用于密封和/或锁定的目的。如图6所示,每个密封环614包括凹槽630以容纳轭状物608的各个环610。在图6中没有显示轭状物608。
[0063]图7是图3右手侧的面罩组件600的部分放大横截面视图。旋转弯管612的第一端612a插入并容纳在第一连接器部分618内。第一端612a可以包括放大的头部,所述放大的头部防止弯管612无意移动离开组件。前端612a可以包括至少一个狭缝613,以允许插入时增大的头部通过弹性弯曲减少其直径。优选地,有多个这种狭缝,例如四个狭缝。如上所述,密封环614可以包括第一和第二突起624,626。在这种情况下,第二突起626可以通过摩擦与旋转弯管612的外周相互作用,并提供密封。此外,旋转弯管612可以设置凹槽或其它结构以容纳第二突起626。
[0064]图7还示意性地显示旋转弯管612和密封环614可包括旋转止挡631。例如,旋转止挡631可以成为轭状物608的一部分。
[0065]作为选择的或另外,如图8所示,旋转弯管612可以设置包括突起634的环633。密封环614可以改成包括旋转止挡632。因此,突起634可以和旋转弯管612一起旋转,直到突起634紧靠旋转止挡632为止。因此空气输送管606的运动可以被限制在预定的运动范围内,例如,大约220°-300°,优选250°-270°,从而最小化或避免空气输送管和患者之间不希望的接触。
[0066]图9是支架组件、第一连接器部分618、轭状物608、密封环614和塞子622的部分横截面视图。图9显示插入到如图1所示的衬垫组件604的右手侧的塞子622,。
[0067]图10显示本发明的一种可选择的实施方案,其中塞子和密封环形成为一个单独的整体件。如图10所示,密封环636包括通常沿着轭状物608的轮廓的凸缘部分638。这在图3的横截面视图中显示得最清楚,在图3中密封环614和轭状物608彼此紧密靠近。
[0068]这些和其它描述的实施方案可以提供改进的空气输送管606和/或旋转弯管612从衬垫组件604分离。此外,这些和其它的实施方案提供一种管线路径的选择,其可以位于衬垫组件604的上面或下面或左或右手侧。同样的,这些实施方案可以被理解为更不突出且明显轻便,包括相对少的部件,容易制造、装配和清洁。
[0069]旋转弯管612可以提供快速释放装置(未显示)。如图7所示,旋转弯管612能够配合并搭扣插入面罩支架616。所述结构允许在限定的角度范围之间在支架616内自由旋转,从而确保管相对于头和枕头不会进入不舒服的位置。
[0070]密封环614这样构造以致于其与旋转弯管612的几何形状配合。另外,密封环614可以连接到轭状物608的环610上。密封环614可以例如通过共同模制永久连接到环610上。例如,图7中的旋转止挡631可以成为环610的一部分。支架616的每一侧上的第一连接器部分618可以相对于密封环614旋转,从而相应地定位衬垫组件604。密封环614密封旋转弯管612,优选具有最低限度的摩擦。每个密封环614都可以容纳塞子622或旋转弯管612。密封环614对于患者,特别是手灵活性降低的患者来说大到足以能够操纵。
[0071]塞子622可以压配合进入密封环614。塞子622也可以被设计成压配合进入支架。塞子622可以由坚硬的聚合物,例如聚丙烯制成。可以设置凹槽(没有显示)以移动塞子622。塞子的作用是密封支架和在空气输送管相对侧面上的衬垫组件。塞子622对于患者,甚至是手灵活性降低的患者来说大到足以能够操纵。
[0072]管606可以永久连接到旋转弯管612的末端。然而,推动摩擦连接也可能是适宜的。管的长度可在200mm至400mm之间,优选地在250至350mm之间,例如,或者其它任何不会妨碍患者面部的长度。
[0073]如图7和8所示,轭状物608和密封环614可以分别提供结构以限制旋转弯管612相对于第一连接器部分618的角度或旋转运动。
[0075]在图11和12所示的实施例中,管定位器900包括连接或附着在帽盔的一条绑带上的第一部分902。例如,第一部分902可以是环的形式,所述环附着在图1所示的帽盔绑带的一部分904上。在帽盔绑带904穿过帽盔扣906之前,通过使帽盔绑带904穿过第一部分902可以完成附着。定位器900包括设置或连接到第一部分902上的第二部分908。第二部分908可以由保持图11所示形状的弹性塑料制成,所述弹性塑料在第二部分908的两个末端912之间限定一空隙910。空隙910的尺寸被设计成小于空气输送管606的直径,从而可靠地支持管606。可选择的,第二部分908可以是环,所述环具有包括配合的钩和环的末端912。如图11和12所示,第二部分可以包括一个或多个狭缝914以容纳空气输送管606的肋状物916(图1),从而防止管606轴向滑动。依靠这种设置,管606可以可靠地保持在患者头部上方的位置。
[0076]图13显示管定位器的平面图,其中相同的附图标记涉及相同的部件。在图13中,显示管定位器的示例性尺寸。请注意的是这些尺寸只是实施例,所述尺寸可被改变达到图示值的大约±20%。在图11-13的实施例中,第一部分902是任选的,因为第二部分908可以单独将管固定到帽盔上。
[0077]图14-18显示根据本发明另一实施方案的定位器10。如图14所示,定位器10包括主体12和突出片14。如图15所示,突出片14包括表面16上的钩形紧固件,主体包括表面18上的环形紧固件。
[0078]图16-18显示定位在样品患者的头部上的定位器10。如图16-18所示,设置定位器10引导空气输送管606围绕患者的头部。定位器10与一部分头部绑带904接合,然后用接合在表面16和18上的钩和环紧固件缠绕空气输送管606。
[0079]定位器12的主体12可以由任何适宜的材料构成,例如Breath-O-preneTM。如果想要增加舒适感,Breath-O-preneTM下面可以设置织物层。构造定位器10使用的所有材料可以得自Accumed Technologies,Inc。
[0080]上文和下文描述的鼻部组件具有若干优点。例如,由于总尺寸和重量小,鼻部组件不突出。由于最小的力施加到患者鼻子上,所述鼻部组件提供高水平的舒适-并消除与鼻梁的接触。该鼻部组件易于使用,并包括最低限度的部件和调节,例如,可以容易地调节入口管道从而向上延伸到患者头部上方或向下延伸到患者下巴下面。加压源可以容易地连接到连接器并与连接器分开,而不用改变帽盔位置。同样,鼻部组件允许更大的管口运动范围以适应更大范围的患者。就是说,通过使支架相对于帽盔组件旋转,管口可以相对于患者的面部旋转。此外,由于跟面部接触的面积变小,绑带的张力不需要同样大。帽盔提供稳定性,例如轭状物有助于保持面罩组件在面部上的位置。设计帽盔的调节,使得拉紧绑带所需的力不施加到患者的面部,例如可以在头部上方相对的方向拉动绑带从而彼此抵消。在性能和舒适之间找到平衡是相对容易的。此外,减少了重量、噪音水平和/或面罩组件的部件的数量。
[0081]包括附图和对本发明优选实施方案的不同方面的描述的附件包括在2003年12月16日提交的美国临时申请60/529,696中,将其全部内容并入到这里作为引用。在标号图中的任意一幅图或者包括尺寸的附件方面来说,这些尺寸只是示例性的,并可以进行改变而不会偏离公开的范围。
[0082]图19显示了本发明另一实施方案的部分分解图。轭状物608包括意欲与邻近或形成为凹槽630的一部分的相应的加宽部分630a连接的加宽部分608a。此外,轭状物608包括意欲容纳密封环614的耳部638的凹口608b。在另一实施方案中,轭状物608和密封环614可以成为一个部件。同样,轭状物和帽盔可以成为一个部件,代替使用缝合或其它紧固件。如在图20可以看到,轭状物608和密封环614可相对彼此搭扣配合,例如可通过肩部621搭扣配合。通过这种结构,防止轭状物和环彼此相对旋转。图20也显示轭状物弯曲点P的通常位置,其允许与患者很好的配合。
[0083]图21至31显示的是图19和20显示的实施方案的另外的图。这种设置的另一方面是轭状物608的环610相对于轭状物608的主体609角度偏移。比较图21和图3,例如,图21的主体609弯曲。例如,图21的前侧609a相对于图21中的后侧609b侧向向外。这种结构有助于使轭状物608的底部朝患者的面部倾斜,使得轭状物更紧密地贴合患者面部的轮廓。
[0084]图32-35显示本发明另一实施方案。该实施方案与图19-31显示并描述的实施方案类似。但是,有两个主要的不同。首先,弯管612在密封环614内自由旋转360°。如图33的部分分解图所示,与图19所示的相比,密封环614不包括止挡632,弯管612不包括突起634。
[0085]其次,如图34所示,密封环614包括选择性地可移动的并可插入的盖614A。换句话说,图9中的塞子622制成两部分而不是一件。盖614A也可以包括通气口或成为通气口,代替或对设置在衬垫子上的通气口进行补充。例如,盖614A的至少一部分外表面可以被制成允许呼出的CO2排出的结构。所述外表面可包括一多孔表面,或者具有多个孔的表面,如美国专利号为6,581,594的文献所述,将其全部内容并入到此处作为引用。外表面也可包括有孔材料从而有助于以相对没有噪音的方式排出CO2。图35显示盖614A的部分分解图。由于管口组件两个侧面上的密封环614是相同的,盖614A和弯管612可以移动并交换,这取决于患者选择使弯管612通过左侧或右侧,。当面罩组件用于患者时,可以这样做。同样,考虑到患者的灵活性,可以除去弯管612。
[0086]图36-41显示根据本发明另一实施方案的塞子20。塞子20意欲与密封,例如图35所示的密封614相配合。塞子20包括第一端22和第二端24,第一端包括增大的头部。邻近第一端22的是增大的圆柱部分26,所述圆柱部分26相对于第一和第二端22和24之间管20的中间部形成肩部28。第二端24包括稍微增大的环形部分30。塞子20包括一个,优选为一对钥匙形的孔32。塞子20可以由聚丙烯,例如BorealisTM或聚酯制成。当塞子20处于原位以及当移动塞子时,孔32的形状允许增强保持力和移动力。参见图36-40,图17显示塞子20处于安装位置。
[0087]图41显示相对于管口组件604处于适当位置的塞子20的部分横截面视图。如所示,增大部分30插入第一连接器部分618。在插入过程中,第二端24(通过孔32)在径向方向稍微压缩,直到增大部分30克制第一连接器部分618的内边缘619。当到达内边缘619时,增大部分30向外弹起从而相对于管口组件604固定塞子。在所述位置,密封环614的密封部分626对圆柱部分26的外表面形成气密密封。此外,肩部28紧靠着第一连接器部分618的末端621。同样的,第一端22的增大头部延伸距离d,所述距离d稍微与密封环614的末端间隔。例如,距离d为大约1-10mm或更大,但优选大约3-5mm。因此,例如根据临床医生或患者优选,在塞子20和旋转弯管612要交换的情况下,患者或医生可以容易地抓住第一端22的增大的头部,从而移动塞子20。如图41所示,增大头部可以具有凹入的外表面。
[0088]图42显示根据本发明另一实施方案的塞子40。在图42中,例如,如关于图36-41的实施方案所述,塞子40意欲插入管口组件604的一侧。塞子40包括第一端42和第二端44。第一端42意欲插入管口组件604内。第二端44意欲设置通气口46,所述通气口46允许呼出气体通过。在该实施方案中,通气口46可以由烧结材料制成。所述烧结材料优选为疏水性的,允许以相对没有噪声的方式排出呼出的气体。在优选的实施方案中,通气口没有过度从远离通气组件604延伸,即它具有低的侧面。因此,通气口46可是一定大小的,以便将其安装在密封环614和/或支架616的第一连接器部分内。
[0089]图43和44仍显示根据本发明另一实施方案的衬垫50。衬垫50包括一个和优选多个通气口52以允许来自衬垫50形成的充气室内部的呼出气体通过。在所述实施例中,衬垫50包括6个通气口52。图44是沿图43的截面44-44的横截面视图。每个通气口52包括朝向外部空气的第一端56和朝向充气室内部的第二端58。在第一和第二端56,58之间设置中间部分60。在优选的形式中,中间部分60包括基本上成圆锥形的截面,然而其它的横截面区域和形状也是可能的。通气口52的长度为大约4-8mm或更长,优选大约6mm。与现有技术图45B相比增加的长度产生更大的层流。此外,中间部分60的圆锥形更容易加工并从装置移动硅树脂部件。当排出呼出的气体时,圆锥形剖面也显示出产生较小的湍流。
[0090]第一端56优选包括一沉头孔62。在所述实施例中,沉孔的深度在0.4至0.6mm或更大的范围内,优选大约为0.5mm。直径在2.5至5mm之间,优选在3至4mm之间。沉孔62的曲率内半径为大约0.1至0.2mm或更大,优选大约为.15mm。同样,减少或消除空气通道的闪点是可能的,从而防止产生明显的噪音。当用硅树脂模制时,可能在锐边产生闪点。因此半径有助于防止闪点。但是,太大的半径可能导致不期望的噪音。可以设置沉孔62以促进例如在压缩模制过程中的加工。
[0091]邻近沉孔62设置部分64,部分64优选具有圆柱形的横截面形状,即基本上直的剖面,并在圆锥形中间部分60和沉孔62之间形成过渡。形成的部分64应该具有大约0.4至0.8mm或更大的长度,优选大约为0.6mm。同样,用于流动的孔的直径尺寸可以容易地控制。孔的最小直径,例如可以为大约1-3mm,但优选大约1.65-1.85mm,优选大约1.75mm。圆锥形截面的内部直径可以更大,例如在大约3-4mm或更大的范围内,优选大约3.0-3.6mm,或大约3.3mm。
[0092]图45A和45C-45H显示通气口52的尺寸和形状的另外的示意性选择。在这些图中,几个图显示了部分矩形的实例部分。以从左到右次序,实例部分的图包括:穿过每个具有示例尺寸的通气口的横截面;自外部空气侧的视图;显示患者接口的主体的相对厚度的侧视图;自患者接口内部的视图;没有尺寸的横截面视图。应当注意这些示例通气口也可设置在通气口插入物、空气输送管、管入口等内,例如由更坚硬的材料,例如聚碳酸酯制成的旋转弯管和/或面罩支架内。同样,这些通气口剖面不限于使用硅树脂材料或用于患者接口本身。此外,孔的数量和每个剖面的各种特征可以以许多方式结合,其中的每一种都在公开的范围内。
[0093]图45A和45C-45H显示的尺寸是示例性的,所述尺寸可以根据实际的噪音要求,通气口的数量(在该实施例中是6个),和/或流动要求等进行改变。例如,最小直径范围为从大约1.0mm或更小至3mm或更大,优选的实施例在图45A和45C-45H中显示。图45B显示现有技术中使用的通气口。图45G所示的实施例与图44所示的实施方案类似。图45G显示图44所示的通气口52。图45E与图45G类似,但不包括基本上圆柱形的部分,图44中所示的相同部分64。从图45C和45F的比较可以看出,部分64的长度可以变化。
[0094]图46-48显示根据本发明另一实施方案的挡板70。挡板70显示与管口组件的支架616一起被连接。支架616与上述的支架类似。图46中透视显示的挡板70也以正视图在图48显示。所述挡板包括一对臂72,其比图47所示的臂74要长。挡板70通过在面罩内产生额外的湍流帮助减少循环噪音,以及也至少部分使通气口出口与空气入口分隔开,这可能对噪音和使CO2最小化都有利。挡板70包括支撑臂72、74的底板76。底板76连接或设置在支架616的内部。例如,如图46所示,底板76包括孔78,所述孔78意欲容纳作为支架616的一部分的互补形的突起。
[0095]图49-51显示根据另一实施方案的弯管612。与图114所示的弯管612相比,图49-51中的弯管612包括一个和优选一对钥匙形的孔613。弯管可以由聚丙烯,例如“Borealis”或聚酯制成。当弯管位于原位和当移动弯管时,孔的形状允许增强的保持力以及移动力。
[0096]图52-54显示根据另一实施方案的支架616。支架616基本上与上述的支架相同。相比之下,支架616包括制成允许呼出的气体排出的通气口625的结构。通气口625可以代替或补充衬垫和/或塞子上的通气口。
[0097]例如,支架616包括主体627和位于主体627的每个侧面上的侧支架元件629。每个侧支架元件629包括整体成形的第一连接器部分618。如所示,主体627包括以一个和优选多个通气孔690形式的通气口625,从而允许呼出的气体通过。正如在图54所示,每个通气孔690可以由延伸穿过主体627的单独的管形成。优选地,通气孔690整体形成在主体627内的一个组件,例如形成通孔。但是,通气孔690可以以任何其它适宜的方式形成于主体627中。
[0098]在显示的实施方案中,支架616包括五个通气孔690。但是,支架616可以具有任何适宜数量的通气孔690。同样,通气孔690可以任何适宜的方式彼此分隔设置,例如以相等或者不相等的间隔远离彼此设置。
[0099]图54显示通气孔690的一种可能的剖面。如所示,每个通气孔690包括朝向外部空气的第一端656,以及朝向由衬垫形成的充气室的内部的第二段658。在第一和第二端656,658之间设置中间部分660。在所示的实施方案中,中间部分660包括具有变化直径的基本上为圆锥形的形状,所述直径朝第二端658变大。当排出呼出的气体时,所述结构有助于产生较少的湍流。但是,圆锥形可以具有任何适宜的尺寸和变化的直径。此外,中间部分660可以具有任何其它适宜的形状。例如,通气孔690可以具有如图45A和45C-45H公开的那些通气口那样的尺寸和形状。此外,为了提供例如期望的噪音要求和/或流动要求,通气孔690的结构、尺寸和数量可以任何适宜的方式进行改变。
[00100]与上述的支架类似,支架616由基本上坚硬的材料制成,例如塑料或聚碳酸酯。这种坚硬的结构能够产生具有一致的通气口形状和尺寸的支架616(对通气孔而言,没有粗糙的边缘,闪点,或损坏),这会提供一种具有一致的低通气口噪音和稳定流速的支架616。
[00101]此外,沿着支架616的主体627的全长设置通气孔690。这种设置增加通气通道的长度,从而减少通气孔690内的湍流并从通气孔690产生更大的层流。因而,在通气孔690产生较少的噪音。
[00102]然而,支架616的主体627内的通气口625可以具有任何其它适宜的结构以允许排出呼出的气体。例如,主体627可以包括多孔表面,烧结材料等。
[00103]此外,管口组件和/或其相关的衬垫可以被鼻面罩和/或鼻衬垫502取代。例如参见图55,56和57。图55和56显示装置,其中支架516包括相对的孔或第一连接器部分518(例如管状的延伸部分),所述孔或第一连接器部分中的每一个都设置有如上所述的密封环。密封环适于包括单独或整体塞子500以关闭一个孔或支架的第一连接器部分,而另一密封环适于与另外的支架孔/第一连接部分配合,并容纳旋转弯管506。当然,弯管506和塞子500的位置可以互换,这取决于患者的选择。图55中,鼻面罩与具有设置在支架516的侧面的弯管506的ResMed’s VISTA面罩类似。图55中的支架的进一步的详情和实施方案在2003年3月19日提交的美国专利申请号为/391,440的文献中公开,在此将其全部内容并入其作为引用。图55中的鼻衬垫501制成在使用时,密封地配合患者的下鼻梁、面颊和唇部的结构。图56中,鼻面罩包括具有撑板部分的鼻衬垫501,所述撑板部分制成在使用时密封配合患者的上鼻梁、面颊和唇部的结构,例如商购自ResMed Ltd.的名称为的患者接口。图56的衬垫的进一步的详情和实施方案在2003年9月5日提交的美国专利申请号为10/655,622的文献中公开,在此将其全部内容并入作为引用。图57中,和ResMed’s VISTA面罩一样,弯管506设置在面罩组件516的前部,而孔/第一连接器部分两者都设置有塞紧的密封环。图57中的弯管的进一步的详情和实施方案在2003年3月19日提交的美国专利申请号为10/390,826的面文献中公开,在此将其全部内容并入作为引用。当然,在每个实施方案中,支架、弯管和/或密封环可以设置有适宜的通气口,以排出从呼吸腔内呼出的气体。
[00104]图58显示另一种装置,其中上述管口组件604采用根据本发明另一实施方案的帽盔702。如所示,帽盔702具有眼镜型结构,所述结构提供围绕患者耳部的侧面部分703,以及靠在患者鼻子上的中间部分705。轭状物708从中间部分705延伸,并包括适于与设置在管口组件604上的各个连接器部分配合的轭环710。衬垫组件604的一端设置有塞子622,并且另一端设置有弯管612。旋转弯管612和塞子622的位置可以互换,这取决于患者的选择。帽盔702提供轻质和低剖面的装置,所述装置可以作为一种帽盔602的选择以支撑患者头部上的管口组件604。
[00105]当结合目前认为是最实用的并优选的实施方案描述本发明时,应当理解本发明不限于公开的实施方案,而且相反,其覆盖包含在本发明精神和范围内的各种改进和等价设置。此外,本发明特别适用于患有OSA的患者,可以理解患有其它疾病(例如,充血性心力衰竭,糖尿病,病态肥胖症,中风,barriatric外科等)的患者可以从上述教导得到益处。此外,上述教导可用于患者和类似的非患者。
Claims (25)
1、一种用于将可吸入气体输送给患者的鼻部组件(600),所述鼻部组件(600)包括:
具有主体的支架(616)及设置在主体的各个侧面上的侧支架元件;
设置在支架(616)的主体上的患者接口;
构造的将可吸入气体输送到支架(616)和患者接口用于患者呼吸的弯管(612),所述弯管(612)制成可移动地与各个所述侧面连接的结构;以及
塞子(20,40,622,636)制成可移动地与支架(616)的各个所述侧面连接的结构,
其中塞子(20,40,622,636)和弯管(612)的位置被构造成可选择性地互换。
2、根据权利要求1所述的鼻部组件,进一步包括设置在一个所述侧面上的塞子。
3、根据权利要求2所述的鼻部组件,其中所述塞子具有包括增大的头部的第一端,所述增大的头部制成当将塞子装入支架时,远离支架的所述侧面间隔布置。
4、根据权利要求2或3所述的鼻部组件,其中所述塞子包括通气口部分。
5、根据权利要求4所述的鼻部组件,其中通气口包括烧结、多孔和/或网状材料,和/或包括多个直径为1-2mm的孔。
6、根据权利要求1-5中任何一项所述的鼻部组件,其中患者接口包括至少一个通气口,所述通气口具有朝向外部空气的第一端以及朝向患者接口内部设置的第二端,其中设置在第一和第二端之间的中间部分包括基本上为圆锥形的部分,所述基本上为圆锥形的部分具有朝向内部变大的可变直径。
7、根据权利要求6所述的鼻部组件,其中在第一端和基本上为圆锥形的部分之间设置基本上为圆柱形的部分。
8、根据权利要求7所述的鼻部组件,其中所述基本上为圆柱形的部分具有小于基本上为圆锥形的部分的长度的长度。
9、根据权利要求4-8中任意一项所述的鼻部组件,其中通气口具有4-8mm的长度。
10、根据权利要求9所述的鼻部组件,其中所述长度为6mm。
11、根据权利要求6-10中任意一项所述的鼻部组件,其中邻近第一端设置沉孔。
12、根据权利要求11所述的鼻部组件,其中沉孔具有0.4-0.6mm的深度,0.1-0.2mm的曲率的内部通道边缘半径。
13、根据权利要求12所述的鼻部组件,其中所述深度为0.5mm,曲率半径为0.15mm。
14、根据权利要求4-13中任意一项所述的鼻部组件,其中通气口具有1-3mm的最小直径。
15、根据权利要求14所述的鼻部组件,其中所述最小直径为1.65-1.85mm。
16、根据权利要求15所述的鼻部组件,其中所述最小直径为1.75mm。
17、根据权利要求1-16中任意一项所述的鼻部组件,进一步包括设置在支架上的挡板。
18、根据权利要求17所述的鼻部组件,其中挡板包括底部和至少一个从底部伸出的臂。
19、根据权利要求1-18中任意一项所述的鼻部组件,其中支架的主体包括至少一个通气口。
20、根据权利要求19所述的鼻部组件,其中所述至少一个通气口具有朝向外部空气的第一端和朝向患者接口内部的第二端,其中设置在第一和第二端之间的中间部分为基本上为圆锥形的形状,所述圆锥形的形状具有朝向第二端变大的可变直径。
21、根据权利要求1-20中任意一项所述的鼻部组件,其中患者接口包括至少一个通气口。
22、根据权利要求1-21中任意一项所述的鼻部组件,进一步包括设置在一个所述侧面上的塞子,其中所述塞子包括通气口。
23、根据权利要求1-22中任意一项所述的鼻部组件,其中所述主体包括多个通气口,所述通气口彼此非均匀间隔布置。
24、根据权利要求19所述的鼻部组件,其中,所述至少一个通气口是沿着所述主体的长度设置。
25、根据权利要求19所述的鼻部组件,其中所述至少一个通气口由延伸穿过主体的管形成。
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2005
- 2005-04-08 CN CN2009101608193A patent/CN101683545B/zh not_active Expired - Fee Related
- 2005-04-08 WO PCT/AU2005/000515 patent/WO2005097247A1/en active Application Filing
- 2005-04-08 US US11/101,657 patent/US7942150B2/en active Active
- 2005-04-08 CN CN200910160820A patent/CN101683546A/zh active Pending
- 2005-04-08 AU AU2005231520A patent/AU2005231520B2/en not_active Ceased
- 2005-04-08 CN CN2005800121908A patent/CN1988930B/zh not_active Expired - Fee Related
- 2005-04-08 NZ NZ586208A patent/NZ586208A/en unknown
- 2005-04-08 EP EP05729503.2A patent/EP1737525B1/en active Active
- 2005-04-08 JP JP2007506619A patent/JP4975611B2/ja not_active Expired - Fee Related
- 2005-04-08 NZ NZ550348A patent/NZ550348A/en unknown
-
2010
- 2010-11-02 US US12/926,213 patent/US8757162B2/en active Active
-
2014
- 2014-04-23 US US14/259,406 patent/US9895505B2/en active Active
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- 2018-01-09 US US15/865,303 patent/US10842957B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
US9895505B2 (en) | 2018-02-20 |
US20110041855A1 (en) | 2011-02-24 |
JP2007532155A (ja) | 2007-11-15 |
WO2005097247A8 (en) | 2005-12-01 |
JP4975611B2 (ja) | 2012-07-11 |
CN1988930B (zh) | 2010-10-27 |
CN101683545B (zh) | 2012-11-28 |
NZ586208A (en) | 2012-01-12 |
AU2005231520A1 (en) | 2005-10-20 |
NZ550348A (en) | 2011-02-25 |
WO2005097247A1 (en) | 2005-10-20 |
US20180126102A1 (en) | 2018-05-10 |
US7942150B2 (en) | 2011-05-17 |
CN101683545A (zh) | 2010-03-31 |
EP1737525A4 (en) | 2009-12-30 |
US8757162B2 (en) | 2014-06-24 |
US10842957B2 (en) | 2020-11-24 |
US20140261433A1 (en) | 2014-09-18 |
EP1737525B1 (en) | 2019-05-22 |
AU2005231520B2 (en) | 2011-07-28 |
CN1988930A (zh) | 2007-06-27 |
EP1737525A1 (en) | 2007-01-03 |
US20050241644A1 (en) | 2005-11-03 |
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