本申请是申请号为200480004811.3的专利申请的分案申请。This application is a divisional application of the patent application with application number 200480004811.3.
在先申请prior application
本申请要求分别于2003年12月16日、2003年8月12日、2003年2月21日、2003年6月27日和2003年7月22日在美国提交的申请号分别为60/529,696、60/494,119、60/448,465、60/482,872和60/488,810的申请的优先权，在此引用各篇全文。This application claims application numbers 60/529,696 filed in the United States on December 16, 2003, August 12, 2003, February 21, 2003, June 27, 2003, and July 22, 2003, respectively , 60/494,119, 60/448,465, 60/482,872, and 60/488,810, each of which is incorporated herein by reference in its entirety.
技术领域technical field
本发明涉及用于治疗例如，呼吸道持续正压(CPAP)的睡眠障碍呼吸(SDB)或无创正压通气(NPPV)的鼻组件。The present invention relates to nasal assemblies for the treatment of, for example, continuous positive airway pressure (CPAP), sleep disordered breathing (SDB) or noninvasive positive pressure ventilation (NPPV).
背景技术Background technique
有些用于治疗SDB的鼻组件设计成插入病人的鼻腔通道。采用鼓风机提供空气或其它可吸入气体并通过柔韧的导管输送到该鼻组件。Some nasal assemblies used to treat SDB are designed to be inserted into a patient's nasal passage. Air or other breathable gas is provided by a blower and delivered to the nasal assembly through a flexible conduit.
鼻组件通常包括比较坚硬的壳体，如框架，和安装在刚性壳体上且构造成插入到病人的鼻腔通道的一对管口(其可以是鼻垫、鼻叉、鼻套管或鼻喷的形式)。这些管口通常使用头带组件保持在适当的位置上。相对硬的壳体和头带组件采用某些类型的连接器进行连接。Nasal assemblies typically include a relatively rigid housing, such as a frame, and a pair of nozzles (which may be nasal pads, prongs, nasal cannula, or nasal spray) mounted on the rigid housing and configured for insertion into a patient's nasal passage. form). These nozzles are typically held in place using a headgear assembly. The relatively rigid shell and headgear assembly are connected using some type of connector.
已知的一种类型的鼻组件在专利号为4,782,382的美国专利(Trimbleetal)中已描述。Trimble公开了一种鼻喷组件20，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装具组件24。该装具组件24设计成可操作地使鼻喷22保持靠近且部分地在病人的鼻腔通道中。One type of nasal assembly known is described in US Patent No. 4,782,382 (Trimble et al). Trimble discloses a nasal spray assembly 20 comprising a nasal spray 22 adapted to be worn close to a patient's nose, and a harness assembly 24 adapted to be worn over the patient's head. The fitting assembly 24 is designed to operatively hold the nasal spray 22 close to and partially within the patient's nasal passage.
该鼻喷22为通常Y型的刚性空心压力通风腔28和一对侧部相互分开的鼻孔部件30的形式。通过可转动地将该部件30安装在压力通风腔28且将该部件30安装在可对该部件30相互进行选择侧面定位的槽中调整鼻孔部件30。而且，使用时装具组件24可进行调整以调节该鼻孔部件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，装配的调节或鼻组件的稳定性直接影响该密封，其可严重地影响病人的舒适度。The nasal spray 22 is in the form of a generally Y-shaped rigid hollow plenum 28 and a pair of spaced side nostril members 30 . The nostril member 30 is adjusted by rotatably mounting the member 30 in the plenum 28 and mounting the member 30 in slots that allow selective lateral positioning of the members 30 relative to each other. Furthermore, the appliance assembly 24 can be adjusted to adjust the fit and seal of the nostril members 30 during use. That is, the force required to maintain an adequate seal is directly related to the force required to maintain the desired fit. Thus, adjustment of fit or stability of the nasal assembly directly affects the seal, which can seriously affect patient comfort.
其它的安装在硬壳上的鼻垫或鼻套管的例子在美国专利5,724,965和6,431,172中公开。Other examples of nasal pads or cannula mounted on a hard shell are disclosed in US Pat. Nos. 5,724,965 and 6,431,172.
由Viasys制造的鼻面具组件，即Spiritus，包括具有一对靠近的或侧部分开的鼻孔部件的压力通风腔。使用时装具组件与该压力通风腔结合以调整该鼻腔部件的配合和密封。与Trimble类似，鼻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度。The nasal mask assembly manufactured by Viasys, Spiritus, includes a plenum with a pair of proximal or laterally spaced nostril members. A appliance assembly engages the plenum to adjust the fit and seal of the nasal component during use. Similar to Trimble, adjustments to the fit or stability of the nasal assembly directly affect the seal, which can adversely affect patient comfort.
由InnoMed制造的鼻面具组件，即NasalAire，包括具有一对靠近的或侧部分开的鼻孔部件的压力通风腔。该鼻孔部件构造成与病人鼻腔的粘膜表面或内通道接合以保持鼻面具组件在病人面部上并提供密封。见如专利号为5,533,506的美国专利。A nasal mask assembly manufactured by InnoMed, the NasalAire, includes a plenum with a pair of proximal or laterally spaced nostril members. The nostril components are configured to engage the mucosal surface or inner passage of the patient's nasal cavity to hold the nasal mask assembly on the patient's face and provide a seal. See, eg, US Patent No. 5,533,506.
由StevensonIndustries制造的鼻面具组件(见专利号为6,012,455的美国专利)，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。牙齿固定器的尺寸设计为啮合在病人口中的牙齿之间，以保持该组件定位在适当位置。A nasal mask assembly manufactured by Stevenson Industries (see US Patent No. 6,012,455), CPAP-Pro, includes a dental retainer, a platform, and an air supply tube with a nasal pad, wherein the platform supports the air supply tube. The dental retainer is sized to engage between the teeth in the patient's mouth to hold the assembly in place.
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。PCT application publication number WO 00/13751 discloses a device comprising a gas delivery member positioned to engage a patient's nose through a mouthpiece fitted to the patient's teeth.
如上所述的现有的鼻组件的普遍问题是病人的舒适性。例如，由于朝向病人的鼻子拉刚性的壳和叉形物的头带组件施加的张力，叉形物往往会刺激病人的鼻子。A common problem with existing nasal assemblies as described above is patient comfort. For example, the prongs tend to irritate the patient's nose due to the tension exerted by the headgear assembly pulling the rigid shell and prongs toward the patient's nose.
另一问题是达到与病人的鼻腔通道密封配合而不损害病人的舒适度。Another problem is to achieve a sealing fit with the patient's nasal passage without compromising patient comfort.
另一问题是由于与叉形物，如其边缘，接触而引起的对病人鼻孔内部的刺激。Another problem is irritation of the inside of the patient's nostrils due to contact with the prongs, such as their edges.
另一问题是由叉形物喷射的空气引起的对病人鼻孔内部的刺激(气流刺激)。Another problem is irritation of the inside of the patient's nostrils caused by the air ejected by the prongs (draft irritation).
又一问题是鼻组件相对于病人鼻子和/或头部的调整以适应病人鼻子的各种形状和角度。Yet another problem is the adjustment of the nasal assembly relative to the patient's nose and/or head to accommodate the various shapes and angles of the patient's nose.
还有一问题是密封与影响病人舒适度的稳定力之间的直接联系。Yet another problem is the direct connection between the seal and the stabilizing forces that affect patient comfort.
发明内容Contents of the invention
本发明的一个方面涉及可使病人更舒适的鼻组件。One aspect of the present invention relates to nasal assemblies that provide greater patient comfort.
本发明的另一方面涉及可与病人鼻腔通道形成有效密封的鼻组件。更适宜地，鼻组件是一种管口组件，包括可舒适地与鼻孔外边缘发生接触而避开敏感的鼻腔内部通道(如粘膜表面或内部通道)的管口。Another aspect of the invention relates to a nasal assembly capable of forming an effective seal with a patient's nasal passage. More suitably, the nasal assembly is a nozzle assembly including a nozzle that comfortably contacts the outer edge of the nostril while avoiding sensitive inner passages of the nasal cavity, such as mucosal surfaces or internal passages.
本发明的再另一方面涉及一种不依靠头带组件的张力来提供管口与病人的鼻通道的有效密封的鼻组件。Yet another aspect of the present invention relates to a nasal assembly that does not rely on tension of the headgear assembly to provide an effective seal of the nozzle with the patient's nasal passage.
本发明的再另一方面涉及一种不引人注目的鼻组件。Yet another aspect of the invention relates to an unobtrusive nasal assembly.
本发明的再另一方面涉及一种易于使用的鼻组件。Yet another aspect of the invention relates to an easy-to-use nasal assembly.
本发明的再另一方面涉及一种保持头带调整设置的鼻组件。Yet another aspect of the present invention relates to a nasal assembly that maintains an adjusted setting of a headgear.
本发明的再另一方面涉及一种有助于脱离密封与稳定力的关联的鼻组件。具体地说，本发明的一方面涉及一种具有使得保持鼻组件在病人的面部的稳定力被分离或至少更好地与用于保持鼻组件和病人面部之间的密封的密封力区别的结构的鼻组件。Yet another aspect of the invention relates to a nasal assembly that facilitates the association of breakaway seals and stabilizing forces. Specifically, one aspect of the invention relates to a structure such that the stabilizing force maintaining the nasal assembly on the patient's face is separated or at least better differentiated from the sealing force used to maintain the seal between the nasal assembly and the patient's face nasal components.
本发明的又一方面涉及一种其管口可较大范围活动的鼻组件。Yet another aspect of the invention relates to a nasal assembly having a nozzle with a wide range of motion.
本发明的另一方面提供一种输送可呼吸气体给病人的鼻组件。该鼻组件包括具有主体和安装在主体各侧面的侧框架构件，各侧框架构件包括整体形成的第一连接部件。管口组件包括角撑板或基座部分和一对管口。使用时，管口组件与具有一对其结构与病人鼻子的鼻腔通道密封结合的管口的框架的主体结合。一对进气导管构造成输送呼吸气体到该框架和管口组件中供病人呼吸。一对第二连接部件可拆卸地且可转动地连接到框架的各第一连接部件。第二连接部件通过角形连接器与进气导管联通。头带组件与至少一个第二连接部件和角形连接器可拆卸地连接以使得框架和管口组件在病人面部保持在所希望调整的位置。Another aspect of the invention provides a nasal assembly for delivering breathable gas to a patient. The nose assembly includes a main body and side frame members mounted on each side of the main body, each side frame member including an integrally formed first connecting member. The nozzle assembly includes a gusset or base portion and a pair of nozzles. In use, the nozzle assembly is combined with the main body of the frame having a pair of nozzles configured to sealingly engage the nasal passages of the patient's nose. A pair of air intake conduits is configured to deliver breathing gas into the frame and mouthpiece assembly for breathing by the patient. A pair of second connecting parts is detachably and rotatably connected to each of the first connecting parts of the frame. The second connection part communicates with the intake duct through the angle connector. The headgear assembly is detachably connected to the at least one second attachment member and the angle connector to maintain the frame and nozzle assembly in a desired adjusted position on the patient's face.
通过下面结合作为说明书一部分并通过实施例说明本发明的原理的附图进行详细描述，本发明的其他方面、特性和优点将更为清楚。Other aspects, features and advantages of the invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings forming a part of the specification and illustrating by way of example the principles of the invention.
附图说明Description of drawings
附图使得对本发明的各实施方式的理解更为容易。附图中：The accompanying drawings facilitate understanding of the various embodiments of the invention. In the attached picture:
图1为安装在病人头部并与病人鼻腔通道啮合的根据本发明的实施例的鼻组件的局部透视图；1 is a partial perspective view of a nasal assembly according to an embodiment of the present invention mounted on a patient's head and engaged with a patient's nasal passage;
图2是为清楚起见去除了一些部件的图1中所示的鼻组件的框架的前视图；Figure 2 is a front view of the frame of the nasal assembly shown in Figure 1 with some components removed for clarity;
图3为图2中所示的框架的截面图；Figure 3 is a cross-sectional view of the frame shown in Figure 2;
图4为图2中所示的框架的侧视图；Figure 4 is a side view of the frame shown in Figure 2;
图5为图1中所示的鼻组件的管口组件的前视图；Figure 5 is a front view of the nozzle assembly of the nose assembly shown in Figure 1;
图6为图5中所示的管口组件的前截面视图；Figure 6 is a front cross-sectional view of the nozzle assembly shown in Figure 5;
图7为图5中所示的管口组件的侧视图；Figure 7 is a side view of the nozzle assembly shown in Figure 5;
图8为图5中所示的管口组件的侧截面视图；Figure 8 is a side sectional view of the nozzle assembly shown in Figure 5;
图9为图1中所示的鼻组件的进气导管和头带连接组件的实施例的透视图；9 is a perspective view of an embodiment of the air inlet conduit and headgear connection assembly of the nasal assembly shown in FIG. 1;
图10为图9中所示的进气导管和头带连接组件的后透视图；Figure 10 is a rear perspective view of the intake duct and headgear connection assembly shown in Figure 9;
图11为适用于图1中所示的鼻组件的进气导管和头带连接组件的另一实施例的透视图；11 is a perspective view of another embodiment of an air inlet conduit and headgear connection assembly suitable for use with the nasal assembly shown in FIG. 1;
图12为图11中所示的进气导管和头带连接组件的后透视图；Figure 12 is a rear perspective view of the intake duct and headgear connection assembly shown in Figure 11;
图13为图1中所示的鼻组件的头上进气导管路径的侧视图；Figure 13 is a side view of the overhead air intake conduit path of the nasal assembly shown in Figure 1;
图14为图1中所示的鼻组件的颌下进气导管路径的侧视图；14 is a side view of the submandibular air intake conduit path of the nasal assembly shown in FIG. 1;
图15为用于在病人头上设置进气导管路径的连接器的透视图；Figure 15 is a perspective view of a connector for routing an air inlet conduit on a patient's head;
图16为用于在病人颌下设置进气导管路径的连接器的透视图；Figure 16 is a perspective view of a connector for routing an air inlet conduit under the patient's jaw;
图17为用于连接图1中所示的鼻组件与压力源的气流发生器连接器的透视图；17 is a perspective view of an airflow generator connector for connecting the nasal assembly shown in FIG. 1 to a pressure source;
图18为用于图1中所示的鼻组件的头带部件的实施例的侧视图；18 is a side view of an embodiment of a headgear component for the nasal assembly shown in FIG. 1;
图19为具有基本扁平翼角的病人鼻子的示意图；Figure 19 is a schematic illustration of a patient's nose with substantially flat wing angles;
图20为具有基本陡削翼角的病人鼻子的示意图；Figure 20 is a schematic illustration of a patient's nose with a substantially steeper wing angle;
图21为管口的密封区的实施例的示意图；Figure 21 is a schematic diagram of an embodiment of a sealing area of a nozzle;
图22为用于说明一般鼻孔比例开口/入口的示意图；Figure 22 is a schematic diagram illustrating a typical nostril ratio opening/entrance;
图23为用于说明计算管口的主基轴的实施例的示意图；Figure 23 is a schematic diagram illustrating an embodiment of calculating the main base axis of a nozzle;
图24为用于说明计算管口的短基轴的实施例的示意图；Figure 24 is a schematic diagram illustrating an embodiment of calculating the short base axis of a nozzle;
图25为安装到病人头部并与病人的鼻腔通道结合的鼻组件的另一实施例的局部透视图；25 is a partial perspective view of another embodiment of a nasal assembly mounted to a patient's head and engaged with a patient's nasal passage;
图26为图25中所示的鼻组件的前面的局部透视图；Figure 26 is a partial perspective view of the front of the nasal assembly shown in Figure 25;
图27为图25中所示的鼻组件的截面图；Figure 27 is a cross-sectional view of the nose assembly shown in Figure 25;
图28为图25中所示的鼻组件的框架的前面透视图；Figure 28 is a front perspective view of the frame of the nasal assembly shown in Figure 25;
图29为图28中所示的框架的后透视图；Figure 29 is a rear perspective view of the frame shown in Figure 28;
图30为图25中所示的鼻组件的管口组件的一半的前面的局部透视图；Figure 30 is a partial perspective view of the front of one half of the nozzle assembly of the nasal assembly shown in Figure 25;
图31为图30所示的鼻组件的侧截面图；Figure 31 is a side cross-sectional view of the nose assembly shown in Figure 30;
图32为图25中所示的鼻组件的进气导管和头带连接器组件的实施例的透视图；32 is a perspective view of an embodiment of the air inlet conduit and headgear connector assembly of the nasal assembly shown in FIG. 25;
图33为图32中所示的进气导管和头带连接器组件的后透视图；Figure 33 is a rear perspective view of the air intake conduit and headgear connector assembly shown in Figure 32;
图34为具有虚影的活动臂的图32中所示的进气导管和头带连接器组件的截面图；34 is a cross-sectional view of the intake conduit and headgear connector assembly shown in FIG. 32 with movable arms in phantom;
图35为用于连接图25中所示的鼻组件所用的管与压力源的气流发生器连接器的透视图；35 is a perspective view of an airflow generator connector for connecting tubing used in the nasal assembly shown in FIG. 25 to a pressure source;
图36为用于说明25中所示的鼻组件的进气导管的路径的侧视图；36 is a side view illustrating the path of the air intake conduit of the nasal assembly shown in 25;
图37为安装在病人头部的图25中所示鼻组件的侧视图；Figure 37 is a side view of the nasal assembly shown in Figure 25 installed on a patient's head;
图38为用于说明安装在病人头部并与病人的鼻腔通道结合的鼻组件的另一实施例的透视图；38 is a perspective view illustrating another embodiment of a nasal assembly mounted on a patient's head and engaged with a patient's nasal passage;
图38B为图38中所示的鼻组件的进气导管和头带连接器的透视图；38B is a perspective view of the air inlet conduit and headgear connector of the nasal assembly shown in FIG. 38;
图39为图38中所示的鼻组件的透视图；Figure 39 is a perspective view of the nasal assembly shown in Figure 38;
图40为图38中所示的鼻组件的框架的透视图；Figure 40 is a perspective view of the frame of the nasal assembly shown in Figure 38;
图41为图38中所示鼻组件的管口组件的透视图；Figure 41 is a perspective view of the nozzle assembly of the nasal assembly shown in Figure 38;
图42为安装在图40所示的框架上的图41所示的管口组件透视图；Figure 42 is a perspective view of the nozzle assembly shown in Figure 41 mounted on the frame shown in Figure 40;
图43为图38中所示的鼻组件的截面图；Figure 43 is a cross-sectional view of the nose assembly shown in Figure 38;
图44为图38中所示的鼻组件的侧截面图；Figure 44 is a side cross-sectional view of the nose assembly shown in Figure 38;
图45为安装到病人头部的图38所示的鼻组件的侧视图，显示出两个进气配置；Figure 45 is a side view of the nasal assembly shown in Figure 38 mounted to a patient's head, showing two air inlet configurations;
图46为当图38所示的鼻组件安装到病人头部时所产生的某些力的示意力图；Figure 46 is a schematic illustration of some of the forces generated when the nasal assembly shown in Figure 38 is mounted on a patient's head;
图47为与用于输送呼吸气体的角形连接器的实施例结合的进气导管的实施例的截面图；47 is a cross-sectional view of an embodiment of an intake conduit in combination with an embodiment of an angled connector for delivering breathing gases;
图47B为进气导管的另一实施例的透视图；Figure 47B is a perspective view of another embodiment of an air inlet conduit;
图48为与用于输送呼吸气体的气流发生器连接器的另一实施例结合的进气导管的另一实施例的截面图；48 is a cross-sectional view of another embodiment of an intake conduit in combination with another embodiment of a flow generator connector for delivering breathing gases;
图48B为进气导管的另一实施例的透视图；Figure 48B is a perspective view of another embodiment of an air inlet conduit;
图49为图38中所示的鼻组件的进气导管的实施例的透视图；49 is a perspective view of an embodiment of an air intake conduit of the nasal assembly shown in FIG. 38;
图50为在与病人的鼻腔通道结合之前的图38中所示的鼻组件的侧视图；Figure 50 is a side view of the nasal assembly shown in Figure 38 prior to engagement with a patient's nasal passage;
图51为与病人的鼻腔通道结合的图38中所示的鼻组件(截面)的前视图；Fig. 51 is a front view (in section) of the nasal assembly shown in Fig. 38 integrated with a patient's nasal passage;
图52为安装在病人头部并与病人的鼻腔通道结合的鼻组件的另一实施例的透视图，显示两种进气配置；52 is a perspective view of another embodiment of a nasal assembly mounted on a patient's head and integrated with a patient's nasal passage, showing two air inlet configurations;
图53为图52所示的鼻组件的透视图；Figure 53 is a perspective view of the nasal assembly shown in Figure 52;
图54为与图52所示的鼻组件的框架结合的管口组件的截面图；Figure 54 is a cross-sectional view of the nozzle assembly combined with the frame of the nose assembly shown in Figure 52;
图55为图52中所示的鼻组件的进气导管和头带连接器的透视图；Figure 55 is a perspective view of the air inlet conduit and headgear connector of the nasal assembly shown in Figure 52;
图56为图52中所示的鼻组件的进气导管和头带连接器的截面图；56 is a cross-sectional view of the air inlet conduit and headgear connector of the nasal assembly shown in FIG. 52;
图57为要与病人鼻腔通道结合的图52中所示鼻组件的截面侧视图；Figure 57 is a cross-sectional side view of the nasal assembly shown in Figure 52 to be integrated with a patient's nasal passage;
图58为与病人的鼻腔通道结合的图52中所示的鼻组件(截面)的前视图；Figure 58 is a front view (in section) of the nasal assembly shown in Figure 52 in combination with a patient's nasal passage;
图59为安装在病人头部并与病人的鼻腔通道结合的鼻组件的另一实施例的透视图；59 is a perspective view of another embodiment of a nasal assembly mounted on a patient's head and engaged with a patient's nasal passage;
图60为从病人头部卸下的图59所示的鼻组件的透视图；Figure 60 is a perspective view of the nasal assembly shown in Figure 59 removed from the patient's head;
图61为图59所示的鼻组件的部分分解图，用于说明框架、管口组件及其夹子；Figure 61 is a partially exploded view of the nose assembly shown in Figure 59, illustrating the frame, nozzle assembly and its clip;
图62为图59所示的鼻组件的部分的透视图，用于说明与框架、管口组件结合的夹子；Figure 62 is a perspective view of the portion of the nose assembly shown in Figure 59, illustrating the clip in combination with the frame, nozzle assembly;
图63为图59所示的鼻组件的部分透视图，用于说明框架、管口组件和夹子之间的结合；Figure 63 is a partial perspective view of the nose assembly shown in Figure 59, illustrating the coupling between the frame, nozzle assembly and clip;
图64为图59所示的鼻组件的部分的局部截面图，用于说明框架、管口组件和夹子之间的结合；Figure 64 is a partial cross-sectional view of a portion of the nose assembly shown in Figure 59, illustrating the bond between the frame, nozzle assembly, and clip;
图65为图59所示的鼻组件的部分的俯视图；Figure 65 is a top view of the portion of the nasal assembly shown in Figure 59;
图65A为图65所示的衬垫的局部放大视图；Figure 65A is a partial enlarged view of the liner shown in Figure 65;
图65B为根据本发明的一方面的力的分布的示意图；Figure 65B is a schematic diagram of force distribution according to an aspect of the present invention;
图66为说明框架、管口组件和夹子之间结合的鼻组件的可供选择的实施例的部分的后视图；Figure 66 is a rear view of a portion of an alternative embodiment of a nasal assembly illustrating the bond between the frame, nozzle assembly, and clip;
图67为说明框架、管口组件和夹子的另一实施例之间的结合的后视图；Figure 67 is a rear view illustrating the coupling between the frame, nozzle assembly and another embodiment of the clip;
图68为说明图66所示的鼻组件与图66所示的框架结合的透视图；Figure 68 is a perspective view illustrating the nose assembly shown in Figure 66 in combination with the frame shown in Figure 66;
图69为说明图67所示的鼻组件与图67所示的框架结合的透视图；Figure 69 is a perspective view illustrating the nose assembly shown in Figure 67 in combination with the frame shown in Figure 67;
图70为说明图66所示的夹子与图66所示的框架和管口组件结合的透视图；Figure 70 is a perspective view illustrating the clip shown in Figure 66 in combination with the frame and nozzle assembly shown in Figure 66;
图71为说明图67所示的夹子与图67所示的框架和管口组件结合的透视图；Figure 71 is a perspective view illustrating the clip shown in Figure 67 in combination with the frame and nozzle assembly shown in Figure 67;
图72为图59所示的鼻组件的第二连接部件的透视图；FIG. 72 is a perspective view of a second attachment component of the nasal assembly shown in FIG. 59;
图73为图59所示的鼻组件的部分的截面图，用于说明框架、第二连接部件和角形连接器之间的结合；Fig. 73 is a cross-sectional view of a portion of the nose assembly shown in Fig. 59, illustrating the coupling between the frame, the second connection member, and the angle connector;
图74为图59所示的鼻组件的角形连接器的透视图；Figure 74 is a perspective view of the angled connector of the nose assembly shown in Figure 59;
图74B为类似于图74但角度不同的透视图；Figure 74B is a perspective view similar to Figure 74 but from a different angle;
图75为图74所示的角形连接器的侧视图；Figure 75 is a side view of the angle connector shown in Figure 74;
图76为图74所示的角形连接器的截面图；Figure 76 is a sectional view of the angled connector shown in Figure 74;
图76A所示为本发明的另一实施例；Figure 76A shows another embodiment of the present invention;
图76B为图76A的分解图；Figure 76B is an exploded view of Figure 76A;
图76C所示为图76A所示组件的第二连接部件；Figure 76C shows the second connecting part of the assembly shown in Figure 76A;
图76D所示为用于图76A中组件的角形连接器；Figure 76D shows an angled connector for the assembly in Figure 76A;
图77为图59所示的鼻组件的气流发生器连接器的透视图；Figure 77 is a perspective view of the airflow generator connector of the nasal assembly shown in Figure 59;
图78为图77所示的气流发生器连接器的截面图；Figure 78 is a cross-sectional view of the airflow generator connector shown in Figure 77;
图79为图59所示的鼻组件的进气导管的实施例的截面图；79 is a cross-sectional view of an embodiment of an air intake conduit of the nasal assembly shown in FIG. 59;
图80为图59所示的鼻组件的头带组件的头带轭状物的透视图；80 is a perspective view of a headgear yoke of the headgear assembly of the nose assembly shown in FIG. 59;
图81为说明头带轭状物(图80)和角形连接器(图74)之间的结合的透视图；Figure 81 is a perspective view illustrating the engagement between the headgear yoke (Figure 80) and the angle connector (Figure 74);
图82为沿图81中的线82-82的截面图；Figure 82 is a cross-sectional view along line 82-82 in Figure 81;
图83为图59所示的鼻组件的头带扣的透视图；Figure 83 is a perspective view of the headgear buckle of the nose assembly shown in Figure 59;
图84为图59所示的鼻组件的透视图，用于说明头带组件的路径；Figure 84 is a perspective view of the nose assembly shown in Figure 59, illustrating the path of the headgear assembly;
图85为图59所示的鼻组件的另一透视图，用于说明头带组件的路径；Figure 85 is another perspective view of the nose assembly shown in Figure 59, illustrating the path of the headgear assembly;
图86为根据本发明实施例构造的鼻组件的俯视图；Figure 86 is a top view of a nasal assembly constructed in accordance with an embodiment of the present invention;
图87为图86所示的鼻组件的侧视图；Figure 87 is a side view of the nasal assembly shown in Figure 86;
图88为图86所示的鼻组件的仰视图；Figure 88 is a bottom view of the nasal assembly shown in Figure 86;
图89图86所示的鼻组件部分的分解图；Figure 89 is an exploded view of the nose assembly portion shown in Figure 86;
图90为鼻组件的实施例的部分透视图；Figure 90 is a partial perspective view of an embodiment of a nasal assembly;
图91为根据本发明的可选实施例的头带连接器的俯视图；Figure 91 is a top view of a headgear connector according to an alternative embodiment of the present invention;
图92为图90所示的鼻组件的中心导管的上面部分的透视图；Figure 92 is a perspective view of the upper portion of the central guide tube of the nasal assembly shown in Figure 90;
图93为图92中所示的中心导管的上面部分的俯视图；Figure 93 is a top view of the upper portion of the central catheter shown in Figure 92;
图94为图90所示的鼻组件的中心导管的下面部分的透视图；Figure 94 is a perspective view of the lower portion of the central guide tube of the nasal assembly shown in Figure 90;
图95为图94中所示的中心导管的下面部分的仰视图；Figure 95 is a bottom view of the lower portion of the central catheter shown in Figure 94;
图96为图86所示的鼻组件的进气导管的透视图；Figure 96 is a perspective view of the air intake conduit of the nasal assembly shown in Figure 86;
图96A为图86所示的鼻组件的Y型进气连接器的示意图；Figure 96A is a schematic illustration of the Y-shaped intake connector of the nasal assembly shown in Figure 86;
图97为图86所示的鼻组件的进气连接器的透视图；Figure 97 is a perspective view of the intake connector of the nasal assembly shown in Figure 86;
图97A为管口处于靠近病人鼻腔通道的第一位置的如图86所示的鼻组件的示意图；97A is a schematic illustration of the nasal assembly shown in FIG. 86 with the nozzle in a first position proximate to a patient's nasal passage;
图97B为管口处于与病人鼻腔通道密封结合的第二位置的如图86所示的鼻组件的示意图；97B is a schematic illustration of the nasal assembly shown in FIG. 86 with the nozzle in a second position in sealing engagement with a patient's nasal passage;
图98为鼻组件的另一实施例的透视图；Figure 98 is a perspective view of another embodiment of a nasal assembly;
图99为如图98所示的鼻组件的管口和角撑板部件的放大透视图；Figure 99 is an enlarged perspective view of the nozzle and gusset components of the nose assembly shown in Figure 98;
图100为如图98所示的鼻组件的进气导管的放大的透视图；Figure 100 is an enlarged perspective view of the air intake conduit of the nasal assembly shown in Figure 98;
图101为说明安装在病人头部的如图98所示的鼻组件的前透视图；Figure 101 is a front perspective view illustrating the nasal assembly shown in Figure 98 installed on a patient's head;
图102为说明安装在病人头部的如图98所示的鼻组件的后透视图；Figure 102 is a rear perspective view illustrating the nasal assembly shown in Figure 98 installed on a patient's head;
图103为说明与病人鼻腔通道结合的如图98所示的鼻组件的前透视图；Figure 103 is a front perspective view illustrating the nasal assembly shown in Figure 98 in combination with a patient's nasal passage;
图104为说明与病人鼻腔通道结合的如图98所示的鼻组件的侧透视图；Figure 104 is a side perspective view illustrating the nasal assembly shown in Figure 98 in combination with a patient's nasal passage;
图105为说明与病人鼻腔通道结合的如图98所示的鼻组件的侧视图；Figure 105 is a side view illustrating the nasal assembly shown in Figure 98 in combination with a patient's nasal passage;
图106为说明与病人鼻腔通道结合的如图98所示的鼻组件的前透视图；Figure 106 is a front perspective view illustrating the nasal assembly shown in Figure 98 in combination with a patient's nasal passage;
图107为安装在病人头部的鼻组件的另一实施例的透视图；Figure 107 is a perspective view of another embodiment of a nasal assembly installed on a patient's head;
图107-1为本发明的再另一实施例的透视图；Figure 107-1 is a perspective view of yet another embodiment of the present invention;
图107-2为本发明的又一实施例的透视图；Figure 107-2 is a perspective view of yet another embodiment of the present invention;
图107A-107C用于说明本发明的另一可选实施例；107A-107C are used to illustrate another alternative embodiment of the present invention;
图107D和107E用于说明本发明的又另一实施例；Figures 107D and 107E are used to illustrate yet another embodiment of the present invention;
图107F为用于说明本发明的另一可选实施例；Figure 107F is another optional embodiment for illustrating the present invention;
图107G和107H用于说明本发明的另一可选实施例；107G and 107H are used to illustrate another alternative embodiment of the present invention;
图107I用于说明本发明的又另一实施例；Figure 107I is used to illustrate yet another embodiment of the present invention;
图107J用于说明本发明的又另一可选实施例；Figure 107J is used to illustrate yet another alternative embodiment of the present invention;
图107K和107L用于说明本发明的又另一实施例；Figures 107K and 107L are used to illustrate yet another embodiment of the present invention;
图107M-107Q用于说明根据本发明的可选的管口的截面图；Figures 107M-107Q are cross-sectional views illustrating alternative nozzles according to the present invention;
图107R为说明类似于如图107Q所示管口的两个管口的透视图；Figure 107R is a perspective view illustrating two nozzles similar to the nozzle shown in Figure 107Q;
图108为鼻组件的再另一实施例的透视图；Figure 108 is a perspective view of yet another embodiment of a nasal assembly;
图108A和108B所示为根据本发明的实施例的导管保持器；108A and 108B illustrate a catheter holder according to an embodiment of the invention;
图108C所示为根据本发明的实施例的另一导管保持器；Figure 108C shows another catheter holder according to an embodiment of the invention;
图109所示为图108所示的鼻组件的部分的等距视图；Figure 109 is an isometric view of a portion of the nasal assembly shown in Figure 108;
图110为根据本发明的鼻组件的部分的截面图；Figure 110 is a cross-sectional view of a portion of a nasal assembly according to the present invention;
图110-1和110-2为根据本发明的通气口的截面图；110-1 and 110-2 are cross-sectional views of vents according to the present invention;
图110A为图110的左侧的局部放大的截面图；Figure 110A is a partially enlarged cross-sectional view of the left side of Figure 110;
图110B为图110的右侧的局部放大的截面图；Figure 110B is a partially enlarged cross-sectional view of the right side of Figure 110;
图111为根据本发明的实施例的密封圈与肘状转体之间接口的分解视图；Figure 111 is an exploded view of the interface between a seal ring and an elbow swivel according to an embodiment of the present invention;
图112为图108所示的面具组件的部分的局部截面图；112 is a partial cross-sectional view of portions of the mask assembly shown in FIG. 108;
图113所示为具有整体插塞和密封组件的本发明的另一实施例；Figure 113 shows another embodiment of the invention with an integral plug and seal assembly;
图114-126所示为本发明的再另一实施例；Figures 114-126 show yet another embodiment of the present invention;
图127-130所示为本发明的又另一实施例；Figures 127-130 show yet another embodiment of the present invention;
图131-133所示为根据本发明的实施例的另一转体肘状物；以及131-133 illustrate another swivel elbow according to an embodiment of the invention; and
图134-135所示为本发明的又一可选实施例。Still another alternative embodiment of the present invention is shown in Figures 134-135.
具体实施方式detailed description
下面是本发明的几个主要示范实施例的描述。各主要示范实施例包括可用在其他实施例中的特征，这对本领域技术人员是显而易见的。The following is a description of several main exemplary embodiments of the invention. Each of the main exemplary embodiments includes features that can be used in other embodiments, as will be apparent to those skilled in the art.
第一示范实施例first exemplary embodiment
图1所示为具有输送可呼吸气体到病人鼻子14的鼻腔通道12的结构的鼻组件10的实施例。该鼻组件10包括框架16和可固定的或可拆卸地与该框架16连接的管口组件18。头带组件20(见图18)优选可拆卸地连接到连接组件22上以使得框架16和管口组件18在病人脸部保持在所希望调整到的位置。进气导管(例如，见图49)也是通过连接组件22可拆卸地连接到框架16上以输送可呼吸气体到框架16和管口组件18中供病人呼吸。头带组件20和进气导管通过进气导管和头带连接组件22可拆卸地连接到框架16上。该连接组件22包括由框架16提供的第一连接部件24(见图2和3)以及适于可拆卸地与第一连接部件24结合的第二连接部件26。该第二连接部件26可拆卸地连接到头带组件20和进气导管，后面将进一步描述。FIG. 1 shows an embodiment of a nasal assembly 10 having a nasal passage 12 configured to deliver breathable gas to a nose 14 of a patient. The nose assembly 10 includes a frame 16 and a nozzle assembly 18 that may be fixedly or removably connected to the frame 16 . Headgear assembly 20 (see FIG. 18) is preferably removably attached to attachment assembly 22 so that frame 16 and nozzle assembly 18 remain in the desired adjusted position on the patient's face. An intake conduit (eg, see FIG. 49 ) is also removably connected to frame 16 via connection assembly 22 to deliver breathable gas into frame 16 and mouthpiece assembly 18 for breathing by the patient. The headgear assembly 20 and air intake duct are detachably connected to the frame 16 by an intake duct and headgear connection assembly 22 . The connection assembly 22 includes a first connection part 24 provided by the frame 16 (see FIGS. 2 and 3 ) and a second connection part 26 adapted to be detachably coupled with the first connection part 24 . The second connection part 26 is detachably connected to the headband assembly 20 and the air intake duct, which will be further described later.
如图2-4所示，框架16包括主体28，其上设置中心开口30以容纳管口组件18。该框架16还包括安装在主体28的各侧面的侧框架构件32，该侧框架构件32优选与框架16的主体28形成一整体。在本实施例中，框架16是用聚合物材料做成的刚性或半刚性结构。但是，框架16可以是半刚性的以在使用时允许框架16相对于病人的脸部有适应性。框架16也可在一定区域上是半刚性结构以在框架16的一定区域适应性地形成挠曲。As shown in FIGS. 2-4 , the frame 16 includes a main body 28 with a central opening 30 disposed therein to receive the nozzle assembly 18 . The frame 16 also includes side frame members 32 mounted on each side of the main body 28 and preferably integral with the main body 28 of the frame 16 . In this embodiment, frame 16 is a rigid or semi-rigid structure made of polymeric material. However, the frame 16 may be semi-rigid to allow the frame 16 to adapt to the patient's face in use. The frame 16 may also be a semi-rigid structure in certain areas to accommodate flexures in certain areas of the frame 16 .
各侧框架构件32包括与其形成整体的第一连接部件24。如图2和3所示，第一连接部件24包括连接段34和指引段36。该连接段34与第二连接部件26互锁以防止第二连接部件26与第一连接部件24轴脱离。指引段36构造成与第二连接部件26棘齿结合/固定以在使用中保持“锁定”在所调整的位置时允许有选择地相对于第一连接部件24环绕轴周向调整第二连接部件26。Each side frame member 32 includes a first connection member 24 integrally formed therewith. As shown in FIGS. 2 and 3 , the first connecting member 24 includes a connecting section 34 and a guiding section 36 . The connecting section 34 is interlocked with the second connecting part 26 to prevent the second connecting part 26 from being disengaged from the first connecting part 24 . The indexing section 36 is configured to be ratcheted/secured with the second link member 26 to allow selective circumferential adjustment of the second link member relative to the first link member 24 about the axis while remaining “locked” in the adjusted position in use 26.
具体地说，各侧框架构件32的连接段34包括一系列将连接段34分成若干有回弹力的柔韧的臂38的凹槽或狭槽37，臂38放射状向内和向外伸缩。各臂38在其自由端设置肋状部分40。使用时，该多个臂38的肋状部分40适于与第二连接部件的相应部分结合，以使第一和第二连接部件24、26相互联结。例如，第一和第二连接部件24、26相互连锁，以在使其轴向脱离第一连接部件24的力到第二连接部件26时防止第二连接部件26与第一连接部件24意外脱离。而且，第一和第二连接部件24、26相互配合以达到良好的密封。Specifically, the connecting section 34 of each side frame member 32 includes a series of grooves or slots 37 which divide the connecting section 34 into a plurality of resiliently flexible arms 38 which flex radially inwardly and outwardly. Each arm 38 is provided with a ribbed portion 40 at its free end. In use, the ribbed portion 40 of the plurality of arms 38 is adapted to engage a corresponding portion of the second connecting member to interconnect the first and second connecting members 24,26. For example, the first and second connecting parts 24, 26 are interlocked to prevent accidental disengagement of the second connecting part 26 from the first connecting part 24 when a force that forces it axially disengaged from the first connecting part 24 is applied to the second connecting part 26 . Furthermore, the first and second connecting members 24, 26 cooperate with each other to achieve a good seal.
各侧框架构件32的指引段36包括多个齿42。该齿42可以选择地与设置在第二连接部件26上的齿44相啮合(见图9和10)。其结果是，第二连接部件26可转动到相对于框架16的所需的位置。使用时，第二连接部件26上的齿44与所选的设置在适当位置上的指引段的齿42之间啮合并转动地将第二连接部件26相对于第一连接部件24锁定，从而相对于框架16锁定。为了调整，用户可手动改变齿66和齿42的位置。The indexing section 36 of each side frame member 32 includes a plurality of teeth 42 . The tooth 42 can selectively engage with a tooth 44 provided on the second connecting member 26 (see FIGS. 9 and 10 ). As a result, the second connection part 26 can be rotated into a desired position relative to the frame 16 . During use, the tooth 44 on the second connecting part 26 and the selected tooth 42 of the guide section that is arranged on the appropriate position are engaged and rotated to lock the second connecting part 26 relative to the first connecting part 24, thereby relatively Locked on the frame 16. For adjustment, the user can manually change the position of teeth 66 and 42 .
根据一实施例，设置指引段36的齿42以致于当预定的力矩加到第二连接部件26时，齿42自动地加力使第二连接部件26的齿44向外以使第二连接部件26转动直到力矩去除而齿42又与第二连接部件26的齿44重新啮合。因此第二连接部件26可在预定的角度内相对于框架16转动调整或指引。可转动调整的角度可根据需要通过改变指引段36上的齿42的数目和位置而改变。调整角度范围使病人能够相对于病人鼻子调整管口组件18的位置。为了达到最佳定位，在一个优选实施例中，管口组件18用一块连接到框架16上的部分模压硅树脂片构成。According to one embodiment, the teeth 42 of the indexing section 36 are arranged so that when a predetermined torque is applied to the second connecting part 26, the teeth 42 automatically energize the teeth 44 of the second connecting part 26 to make the second connecting part 26 outward. 26 is rotated until the torque is removed and the teeth 42 re-engage with the teeth 44 of the second connecting member 26 . Thus the second connecting member 26 can be rotationally adjusted or indexed relative to the frame 16 within a predetermined angle. The angle of the rotatable adjustment can be changed by changing the number and position of the teeth 42 on the guide section 36 as required. The range of adjustment angles enables the patient to adjust the position of the nozzle assembly 18 relative to the patient's nose. In a preferred embodiment, nozzle assembly 18 is constructed from a partially molded piece of silicone attached to frame 16 for optimal positioning.
在该示范实施例中，调整或指引操作与连接操作正交以将第二连接部件26与第一连接部件24脱离的可能性减到最小。In the exemplary embodiment, the adjustment or indexing operation is orthogonal to the connection operation to minimize the possibility of disengagement of the second connection member 26 from the first connection member 24 .
如图4所示，主体28包括形成容纳管口组件18的中心开口30的相对的侧壁46。该侧壁46用于与管口组件18相应的部分结合以使管口组件18和框架16彼此结合，后面将进一步描述。As shown in FIG. 4 , the body 28 includes opposing side walls 46 that form a central opening 30 that receives the nozzle assembly 18 . The side wall 46 is used to engage with a corresponding portion of the nozzle assembly 18 to couple the nozzle assembly 18 and the frame 16 to each other, as will be further described later.
如图5-8所示，管口组件18包括基座部分48和连接到其上的一对管口50。基座部分48具有适于与框架16的侧壁46密封结合的侧壁52和中心壁54。该对管口各具有第一部分56和第二部分58。第一部分56连接到基座部分48的中心壁54上，与中心壁54上的出气口导通。使用时第二部分58与病人鼻子14的鼻腔通道12密封结合并使得鼻组件10与病人的鼻腔通道12之间密封。当管口组件18连接到框架16上，管口组件18和框架16一起形成通过一对管口50引导呼吸气体到病人鼻腔的导管。As shown in FIGS. 5-8 , the nozzle assembly 18 includes a base portion 48 and a pair of nozzles 50 connected thereto. The base portion 48 has side walls 52 and a central wall 54 adapted to sealingly engage the side walls 46 of the frame 16 . The pair of nozzles each have a first portion 56 and a second portion 58 . The first portion 56 is connected to the central wall 54 of the base portion 48 in communication with an air outlet on the central wall 54 . In use, the second portion 58 sealingly engages the nasal passage 12 of the patient's nose 14 and provides a seal between the nasal assembly 10 and the nasal passage 12 of the patient. When nozzle assembly 18 is attached to frame 16, nozzle assembly 18 and frame 16 together form a conduit for directing breathing gases through a pair of nozzles 50 to the patient's nasal cavity.
在该示范实施例中，管口组件18采用可简单装配的搭扣，如搭扣配合、推销配合或伸展配合，可拆卸地连接到框架16上。例如，基座部分48的侧壁52可包括肋状物或凹槽/凹口，其可采用搭扣配合与框架16的各侧壁上的凹口/肋状物互锁。但是，管口组件18可采用其他适合的方式可拆卸地连接到框架16上，例如，现有技术已知的摩擦或干涉配合和/或舌榫装配。或者，例如，管口组件18可通过粘合剂或紧固件刚性地连接到框架16上。而且，管口组件18可与框架16形成一整体，或模压。即，管口组件和框架可制成具有不同厚度和硬度的整体结构以增加刚性。In the exemplary embodiment, nozzle assembly 18 is removably attached to frame 16 using a snap-fit, push-pin fit, or stretch fit that can be easily assembled. For example, the side walls 52 of the base portion 48 may include ribs or grooves/notches that may interlock with the notches/ribs on the respective side walls of the frame 16 using a snap fit. However, the spout assembly 18 may be removably attached to the frame 16 by other suitable means, such as a friction or interference fit and/or a tongue-and-groove fit as known in the art. Alternatively, nozzle assembly 18 may be rigidly connected to frame 16 by adhesive or fasteners, for example. Furthermore, the nozzle assembly 18 may be integral with the frame 16, or molded. That is, the nozzle assembly and frame can be made as a unitary structure with different thicknesses and stiffnesses to increase rigidity.
优选，管口组件18是柔性的，从而允许管口组件18与框架16之间可相对活动，以增加舒适度且适应病人脸型特性的变化。而且，基座部分48可扩张和收缩以改变框架16和该对管口50之间的距离，后面将进一步描述。即，中心壁54优选用弹性的和/或柔软的材料制作以在使用时可从通常的平的结构变形到通常的弯曲结构，例如，引入加压气体时膨胀，从而将管口50移向病人的鼻子。基座部分48的其他部分，例如，侧壁52，也可变形/膨胀。Preferably, the nozzle assembly 18 is flexible to allow relative movement between the nozzle assembly 18 and the frame 16 to increase comfort and accommodate changes in the characteristics of the patient's face. Also, the base portion 48 is expandable and contractible to vary the distance between the frame 16 and the pair of nozzles 50, as will be described further below. That is, the central wall 54 is preferably made of a resilient and/or pliable material to deform in use from a generally flat configuration to a generally curved configuration, e.g., expand upon introduction of pressurized gas, thereby moving the spout 50 toward patient's nose. Other portions of the base portion 48, such as the side walls 52, may also deform/expand.
在该示范实施例中，基座部分48具有普通的犬骨(dog-bone)形状。但是，基座部分48可以是任何合适的形状，包括避免与病人脸部敏感部位接触的形状，例如凹口基座形状，以防止接触病人的隔膜或使对这些部位的接触压力最小化。In the exemplary embodiment, base portion 48 has a generally dog-bone shape. However, base portion 48 may be any suitable shape, including shapes that avoid contact with sensitive areas of the patient's face, such as a notched base shape to prevent contact with the patient's diaphragm or to minimize contact pressure on these areas.
如图1、5和6所示，鼻组件的第二部分58轮廓具有密封鼻孔下侧(例如鼻孔口缘附近的区域)的部分和在使用时进入病人的鼻腔通道的另一部分的形状(例如，锥形、圆锥形、斜截锥形等)。但是，管口可以是例如，鼻叉形、套管或鼻喷的形式，并可以任何适当的方式与鼻腔通道12密封接合。例如，管口50可在鼻腔通道内、靠着鼻腔通道、在鼻腔通道周围密封或几种方式的组合。管口50可以做成轮廓与病人鼻子的内解剖特征相配。另外，可提供不同尺寸和/或形状的管口，如，小、中、以及大的管口以适应病人鼻子的范围。As shown in Figures 1, 5 and 6, the second portion 58 of the nasal assembly is contoured to have a portion that seals the underside of the nostril (e.g., the area near the rim of the nostril) and another portion that enters the patient's nasal passage in use (e.g., , cone, cone, oblique truncated cone, etc.). However, the nozzle may be in the form of, for example, a nasal prong, a cannula, or a nasal spray, and may be in sealing engagement with the nasal passage 12 in any suitable manner. For example, the nozzle 50 may seal within the nasal passage, against the nasal passage, around the nasal passage, or a combination of several. The nozzle 50 can be contoured to match the internal anatomy of the patient's nose. Additionally, different sizes and/or shapes of orifices may be provided, eg, small, medium, and large orifices to accommodate the confines of a patient's nose.
在示范实施例中，管口50的第一部分56与第二部分相比具有已减小的横截面以允许管口相对于基座部分48移动，并从而相对于框架16移动，以增加舒适度并适应病人脸部特征的变化。In the exemplary embodiment, the first portion 56 of the nozzle 50 has a reduced cross-section compared to the second portion to allow movement of the nozzle relative to the base portion 48, and thus relative to the frame 16, for increased comfort. and adapt to changes in the patient's facial features.
在一个实施例中，鼻组件10采用根据病人来定制的管口，其可拆卸地安装在基座部分48或框架16上。在优选的方式中，管口用基本柔软的聚合物材料制成，如硅树脂弹性体。通过先在现场或远处扫描病人的鼻子，然后利用该数据制造接口，如模具制造者，制成与各病人的鼻子相配的独特的管口。扫描可采用非接触或接触的方法。非接触，例如拍照，或通过利用探测器的物理接触，或通过收集所希望接触的接口的鼻孔内的印象。一旦制成了一对合适的管口，就可发送给用户以与病人配合。预先制成或定制的形状的优点是截面区域可最大化以减小流阻。另外，预先制成的形状的使用可改善舒适度且可采用增加坚硬度的材料如半硬的塑料以更好地防止变形，从而使病人鼻孔的管口变形最小化。另外，由于与基座部分48连接，采用刚性的塑料允许薄壁段并允许管口柔软，例如，基座部分48是柔软和适应的。In one embodiment, nasal assembly 10 employs a patient-customized nozzle that is removably mounted on base portion 48 or frame 16 . In a preferred form, the nozzle is made of a substantially soft polymeric material, such as a silicone elastomer. By first scanning a patient's nose in situ or remotely, and then using that data to manufacture an interface, such as a mold maker, to create a unique nozzle that fits each patient's nose. Scanning can be by non-contact or contact methods. Non-contact, such as taking pictures, or by physical contact using a probe, or by collecting intranasal impressions of the desired contact interface. Once a suitable pair of nozzles is made, it can be sent to the user for fitting with the patient. An advantage of prefabricated or custom shapes is that the cross-sectional area can be maximized to reduce flow resistance. Additionally, the use of prefabricated shapes can improve comfort and allow the use of increased stiffness materials such as semi-rigid plastics to better resist deformation, thereby minimizing deformation of the nozzles of the patient's nostrils. Additionally, the use of a rigid plastic allows for a thinner wall section and allows the spout to be flexible due to the connection to the base portion 48, eg, the base portion 48 is flexible and conformable.
在示范实施例中，管口50与基座部分48用可变形的和可膨胀的材料模压成一整体。管口50与基座部分48可用柔软的、皮肤相容的材料如硅树脂制成。例如，管口50与基座部分48可利用现有技术已知的的注模、压制和/或传递模塑法制成。In the exemplary embodiment, the nozzle 50 is molded integrally with the base portion 48 from a deformable and expandable material. The nozzle 50 and base portion 48 may be made of a soft, skin compatible material such as silicone. For example, the nozzle 50 and base portion 48 may be formed using injection molding, compression and/or transfer molding methods known in the art.
但是，管口50与基座部分48可用任何适合的材料和任何适当的方法制作。例如，基座部分48和管口50可分开制作并用，例如粘合剂和/或机械紧固器永久地相互连接到一起，或者，基座部分48和管口50可分开制作并可拆卸地相互连接到一起。However, the nozzle 50 and base portion 48 may be made of any suitable material and by any suitable method. For example, the base portion 48 and the nozzle 50 may be separately fabricated and permanently attached to each other, such as with adhesive and/or mechanical fasteners, or the base portion 48 and the nozzle 50 may be separately fabricated and removably attached. connected to each other.
如前所述，第二连接部件26设置用于可拆卸地将头带组件20和进气导管与框架16连接。如图9和10所示，各第二连接部件26是通过例如，注模、压模和/或吹塑法制成的一整体的聚合体块(如硅树脂)。各第二连接部件26包括前面部分60和后面部分62的主体。前面部分60与设置在框架16上的第一连接部件24互锁而后面部分62可拆卸地连接到头带组件20和进气导管。如图1所示，前面部分60和后面部分62相互成一角度以致于使用时第二连接部件26适应病人脸部的轮廓。As previously mentioned, the second connecting member 26 is configured to detachably connect the headgear assembly 20 and the air intake duct to the frame 16 . As shown in Figures 9 and 10, each second connecting member 26 is a unitary polymeric block (eg, silicone) formed by, for example, injection molding, compression molding and/or blow molding. Each second connection member 26 includes a main body of a front portion 60 and a rear portion 62 . The front portion 60 is interlocked with the first connecting member 24 provided on the frame 16 and the rear portion 62 is detachably connected to the headgear assembly 20 and the air intake duct. As shown in Figure 1, the front portion 60 and the rear portion 62 are angled relative to each other so that the second attachment member 26 conforms to the contours of the patient's face in use.
具体地说，前面部分60提供普通的圆柱形导管64，在其内表面具有凹槽66。该凹槽66适于接受第一连接部件24上的多个臂38的肋状部分40。即，当第一连接部件24插入第二连接部件26的导管64中时，多个臂38相互受力。一旦臂38的肋状部分40到达凹槽66，臂38向外弹入凹槽66中以使得第一和第二连接部件24、26之间彼此互锁接合。为了使第二连接部件26与框架16脱离，病人用足够的力简单地从框架沿轴向向外拉该第二连接部件26以使该肋状部分40从凹槽66释放。Specifically, the front portion 60 provides a generally cylindrical conduit 64 having a groove 66 in its inner surface. The groove 66 is adapted to receive the ribbed portion 40 of the plurality of arms 38 on the first connection member 24 . That is, when the first connection member 24 is inserted into the conduit 64 of the second connection member 26, the plurality of arms 38 are mutually stressed. Once the ribbed portion 40 of the arm 38 reaches the groove 66, the arm 38 springs outwardly into the groove 66 to bring the first and second connecting members 24, 26 into interlocking engagement with each other. To disengage the second connecting member 26 from the frame 16 , the patient simply pulls the second connecting member 26 axially outward from the frame with sufficient force to release the ribbed portion 40 from the groove 66 .
前面部分60还提供设置第二连接部件26的齿的横杆68。如上所述，齿44与多个第一连接部件24的齿42接合以允许第二连接部件26相对于第一连接部件24有选择的转动调节，并因此相对于框架16转动调节。该横杆68起到片弹簧的作用以弹性偏置齿44与第一连接部件24的齿42接合。The front part 60 also provides a crossbar 68 on which the teeth of the second connection part 26 are provided. As noted above, the teeth 44 engage the teeth 42 of the plurality of first link members 24 to allow selective rotational adjustment of the second link member 26 relative to the first link members 24 , and thus relative to the frame 16 . The crossbar 68 acts as a leaf spring to elastically bias the teeth 44 into engagement with the teeth 42 of the first link member 24 .
如图9和10所示，第二连接部件26的后面部分62包括横杆70，其形成开口供头带组件20的带穿过并可拆卸地连接。然而，该横杆70可设置提供一个以上开口以连接头带组件20。例如，如图11和12所示，该第二连接部件26’包括横杆71，其上设置一对开口供头带组件20的一对带穿过并可拆卸地连接。As shown in FIGS. 9 and 10, the rear portion 62 of the second connecting member 26 includes a crossbar 70 that defines an opening for the straps of the headgear assembly 20 to pass through and be removably connected. However, the crossbar 70 may be configured to provide more than one opening for connecting the headgear assembly 20 . For example, as shown in Figures 11 and 12, the second connecting member 26' includes a crossbar 71 on which a pair of openings are provided for a pair of straps of the headgear assembly 20 to pass through and be detachably connected.
该后面部分62还提供适于与输送呼吸气体到框架16和管口组件18的进气导管连接的延长导管72。在示范实施例中，后面部分62的导管72与前面部分60的导管64具有不同的横截面形状以易于连接到该进气导管。但是，前面和后面部分60、62的导管64、72可分别具有相似的横截面积。The rear portion 62 also provides an extension conduit 72 adapted to connect with the intake conduit delivering breathing gas to the frame 16 and nozzle assembly 18 . In the exemplary embodiment, conduit 72 of rear portion 62 has a different cross-sectional shape than conduit 64 of front portion 60 to facilitate connection to the intake conduit. However, the conduits 64, 72 of the front and rear portions 60, 62, respectively, may have similar cross-sectional areas.
图13和14所示为鼻组件10的第一对进气导管74之一和第二对进气导管76之一的路径。第一对导管74的第一端连接到第二连接部件26的各导管72。第一对导管74的第二端连接到第二对进气导管76的各第一端。第二对进气导管的第二端连接到提供加压可呼吸气体的气源。结果，加压气体可通过第一、第二对进气导管74、76进入到框架16和基座部分48，并通过管口50供病人呼吸。如图1所示，框架16包括从框架16稍微向外突出的排气孔78以及包括排放CO2的一系列开口。13 and 14 illustrate the paths of one of the first pair of intake conduits 74 and one of the second pair of intake conduits 76 of the nasal assembly 10 . First ends of the first pair of conduits 74 are connected to respective conduits 72 of the second connection part 26 . Second ends of the first pair of conduits 74 are connected to respective first ends of a second pair of intake conduits 76 . The second end of the second pair of intake conduits is connected to a source of pressurized breathable gas. As a result, pressurized gas can enter the frame 16 and base portion 48 through the first and second pair of inlet conduits 74, 76 and through the nozzle 50 for the patient to breathe. As shown in FIG. 1 , the frame 16 includes vent holes 78 protruding slightly outwardly from the frame 16 and including a series of openings that vent CO2 .
如图13所示，第一、第二对进气导管74、76路径可向上延伸到病人的头部上方。例如，在图13中，第一对进气导管74的长度可以大约为120-160mm，优选是大约140mm，而第二对进气导管76的长度可以大约为160-200mm，优选是大约180mm。但是也可用其他尺寸。在示范实施例中，第一对进气导管74与水平成大约30°角而第二对进气导管76与水平成大约90°角，或与第一对进气导管74成大约60°角。但是，第一、第二对进气导管74、76可具有任何适合的长度且可以采用任何方式的向上延伸到病人头部上方的路径。As shown in FIG. 13, the paths of the first and second pair of intake conduits 74, 76 may extend upwardly above the patient's head. For example, in FIG. 13, the length of the first pair of intake ducts 74 may be approximately 120-160 mm, preferably approximately 140 mm, while the length of the second pair of intake ducts 76 may be approximately 160-200 mm, preferably approximately 180 mm. However, other sizes are also available. In the exemplary embodiment, the first pair of intake ducts 74 are at an angle of approximately 30° from horizontal and the second pair of intake ducts 76 are at an angle of approximately 90° to horizontal, or at an angle of approximately 60° to the first pair of intake ducts 74 . However, the first and second pair of intake conduits 74, 76 may be of any suitable length and may take any manner of path extending upwardly above the patient's head.
或者，如图14所示，第一、第二对进气导管74、76可向下沿病人下颚下面。例如，在图14中，第一对进气导管74的长度可以为大约40-80mm，优选是大约60mm，而第二对进气导管76的长度可以为大约180-220mm，优选是大约200mm。在示范实施例中，第一对进气导管74与水平成大约-20°至40°角，优选是与水平成大约30°角，而第二对进气导管76与水平成大约-90°角，或与第一对进气导管74成大约-120°角。但是，第一和第二对进气导管可具有任何适合的长度且可以采用任何方式的向上延伸到病人头部的路径。Alternatively, as shown in FIG. 14, the first and second pairs of air intake conduits 74, 76 may run downwardly under the patient's chin. For example, in FIG. 14, the length of the first pair of intake ducts 74 may be about 40-80 mm, preferably about 60 mm, while the length of the second pair of intake ducts 76 may be about 180-220 mm, preferably about 200 mm. In the exemplary embodiment, the first pair of intake ducts 74 are at about -20° to 40° from horizontal, preferably at about 30° from horizontal, and the second pair of intake ducts 76 are at about -90° from horizontal angle, or approximately -120° to the first pair of intake ducts 74 . However, the first and second pair of inlet conduits may be of any suitable length and may take any manner of routing upward to the patient's head.
图15和图16示出了用于将第一对进气导管74的第二端连接到第二对进气导管76的各第一端的连接器的示意图。图15中示出的连接器80适于与路径向上延伸到病人头部上方的第一、第二对进气导管74、76成一角度。图16中示出的连接器82适于与路径向下到病人下颚下面的第一、第二对进气导管74、76成一角度。15 and 16 show schematic views of connectors for connecting the second ends of the first pair of intake conduits 74 to respective first ends of the second pair of intake conduits 76 . The connector 80 shown in Figure 15 is adapted to be at an angle with the first and second pair of intake conduits 74, 76 that extend upwardly over the patient's head. The connector 82 shown in Figure 16 is adapted to be at an angle with the first and second pair of intake conduits 74, 76 that route down below the patient's chin.
图17示出了用于将第二对进气导管76的第二端与气压源互连的气流发生器连接器84。具体地说，气流发生器连接器84包括连接到第二对进气导管76的一端的第一导管86和连接到第二对进气导管76的另一端的第二导管88。气流发生器连接器84包括连接到与气压源连接的导管的第三导管90。该第三连接头90可包括旋转机械装置或柔性的连接头以允许气流发生器连接器84和与气压源相关的导管之间的相对移动。Figure 17 shows the flow generator connector 84 for interconnecting the second end of the second pair of intake conduits 76 with a source of air pressure. Specifically, the flow generator connector 84 includes a first conduit 86 connected to one end of the second pair of intake conduits 76 and a second conduit 88 connected to the other end of the second pair of intake conduits 76 . The air flow generator connector 84 includes a third conduit 90 connected to a conduit connected to a source of air pressure. The third connector 90 may comprise a rotary mechanism or a flexible connector to allow relative movement between the flow generator connector 84 and the conduit associated with the air pressure source.
在示范实施例中，进气导管74、76提供单气流通道。但是，该导管74、76，连接部件24、26，以及连接器80、82、84可提供一条以上的气流通道。In the exemplary embodiment, intake conduits 74, 76 provide a single air flow passage. However, the conduits 74, 76, connecting members 24, 26, and connectors 80, 82, 84 may provide more than one airflow path.
该进气导管74、76可用任何适合的方式制作。例如，该进气导管74、76可以是挤压而成和该导管可以是注模而成。另外，该进气导管74、76可用任何适合的聚合物材料，如硅树脂或热塑性塑料弹性体，例如制成。The intake ducts 74, 76 can be made in any suitable manner. For example, the intake conduits 74, 76 may be extruded and the conduits may be injection molded. In addition, the intake conduits 74, 76 may be of any suitable polymeric material, such as silicone or thermoplastic elastomers, for example production.
另外，该进气导管74、76可用抗变形的、防压碎的和不扭折的管形成，如专利号为6,044,844的美国专利公开的，其全文结合在此供参考。Alternatively, the intake conduits 74, 76 may be formed from deformation-resistant, crush-resistant, and kink-resistant tubing, as disclosed in US Patent No. 6,044,844, which is incorporated herein by reference in its entirety.
该进气导管74、76和各连接部件24、26和/或连接器80、82、84可用摩擦型配合、机械紧固件、粘合剂、共模压、内嵌模，或任何其他适合的方式保持。The intake conduits 74, 76 and respective connecting members 24, 26 and/or connectors 80, 82, 84 may be friction-type fit, mechanical fasteners, adhesives, co-molded, insert molded, or any other suitable way to keep.
使用时，加压气体通过气流发生器连接器84的连接器90输入并通过第二组进气导管76前进到第一组进气导管74中，再进入到框架16的两个侧框架构件32。气体通过框架16进到基座部分48和管口50，然后输入到病人的鼻腔通道12。从病人的鼻子排出的气体可通过设在框架16中的排气孔78排出。In use, pressurized gas is input through connector 90 of flow generator connector 84 and proceeds through second set of intake conduits 76 into first set of intake conduits 74 and into both side frame members 32 of frame 16 . Gas passes through the frame 16 to the base portion 48 and nozzle 50, and then into the nasal passage 12 of the patient. Air expelled from the patient's nose can escape through vent holes 78 provided in the frame 16 .
头带组件20可拆卸地连接到与框架16连接的第二连接部件26上以使得框架16和管口组件18可在病人脸部保持在所希望调整到的位置。如图18所示，头带组件20包括两个侧面部分92，使后面部分94连接该侧面部分92。各侧面部分92包括侧带96。与两个侧面部分92相连接的后面部分94包括越过病人头顶的上带98和绕过病人头后部的后带100。但是，头带组件可固定地连接到框架上。The headgear assembly 20 is removably attached to a second attachment member 26 attached to the frame 16 so that the frame 16 and nozzle assembly 18 can be held in the desired adjusted position on the patient's face. As shown in FIG. 18 , the headgear assembly 20 includes two side portions 92 with a rear portion 94 connecting the side portions 92 . Each side portion 92 includes a side strap 96 . The rear portion 94, joined to the two side portions 92, includes an upper strap 98 that goes over the top of the patient's head and a rear strap 100 that goes around the back of the patient's head. However, the headgear assembly may be fixedly attached to the frame.
各侧带96可拆卸地连接到第二连接部件26上。具体地说，各侧带96端部具有减小的宽度，使该侧带96可卷绕设置在第二连接部件26的横杆70。该侧带96紧固在各横杆70上可采用挂钩和环形材料，如。因而，侧带96可以相对于第二连接部件26进行适应性调整。Each side strap 96 is detachably attached to the second attachment member 26 . Specifically, the ends of each side strap 96 have a reduced width so that the side strap 96 can be wound around the crossbar 70 disposed on the second connecting member 26 . This side band 96 is fastened on each cross bar 70 and can adopt hook and loop material, as . Thus, the side straps 96 can be adapted relative to the second attachment member 26 .
上带98和后带100通过设置在侧带96上的带扣102可拆卸地连接到侧带96上。该带扣102可用粘合剂、缝合和/或其他已知的方式接合在侧带96上。在示范实施例中，带扣102包括单个横杆以使上带98和后带100结合在一起。但是，可采用任何其他适合的带扣结构使上带98和后带100与侧带96相互连接。The upper strap 98 and the rear strap 100 are detachably connected to the side strap 96 by buckles 102 provided on the side strap 96 . The buckle 102 may be joined to the side strap 96 with adhesive, stitching, and/or other known means. In the exemplary embodiment, buckle 102 includes a single crossbar to hold upper strap 98 and rear strap 100 together. However, any other suitable buckle structure may be used to interconnect the upper strap 98 and the rear strap 100 with the side straps 96 .
头带组件20的带96、98和100可用软且柔韧的复合材料制成。例如，带96、98和100可包括由织物材料构成的一层和由聚合体构成的另一层的两层材料。另外，头带组件20可包括一个或多个连接到其上的刚性构件以在特定的平面和方向增加头带组件的刚性，有助于使用时鼻组件10稳定在病人头部。Straps 96, 98, and 100 of headgear assembly 20 may be made of a soft and pliable composite material. For example, straps 96, 98, and 100 may include two layers of material, one layer consisting of a fabric material and another layer consisting of a polymer. Additionally, the headgear assembly 20 may include one or more rigid members attached thereto to increase the rigidity of the headgear assembly in particular planes and orientations to help stabilize the nasal assembly 10 on the patient's head during use.
另外，头带组件20可包括多条带以支持鼻组件10在病人头部。例如，如图11和12所示，各条侧带96可包括一对用于第二连接部件26的带。或者，头带组件20可制成一体的结构。Additionally, headgear assembly 20 may include multiple straps to support nasal assembly 10 on the patient's head. For example, as shown in FIGS. 11 and 12 , each side strap 96 may include a pair of straps for the second attachment member 26 . Alternatively, headgear assembly 20 may be made as a unitary structure.
如图1所示，基座部分48从框架16向外延伸以提供额外的表面面积或底部面积。当受压的空气进入框架16，基座部分48充气，其移动管口50使其与病人鼻腔通道12密封接合。例如，基座部分48沿鼻孔方向的扩张使得管口移动与病人鼻腔通道12密封接合。As shown in FIG. 1 , base portion 48 extends outwardly from frame 16 to provide additional surface or floor area. When pressurized air enters the frame 16, the base portion 48 inflates, which moves the nozzle 50 into sealing engagement with the nasal passage 12 of the patient. For example, expansion of the base portion 48 in the direction of the nostrils moves the nozzle into sealing engagement with the nasal passage 12 of the patient.
另外，一部分密封力可由象弹簧一样顶住病人的鼻孔预加载的第一部分56提供。Alternatively, a portion of the sealing force may be provided by the first portion 56 being preloaded like a spring against the patient's nostrils.
也就是说，这种结构的基座部分48可扩张和收缩以改变框架16和管口50之间的距离。基座部分48使得管口50在管口50与病人鼻腔通道12靠近的第一位置和管口50移动与病人鼻腔通道12密封接合的第二位置之间移动。具体地说，在未充气的情况下，管口50与病人鼻腔通道12分隔开或轻微接触。当鼻组件10受到气体压力时，基座部分48充气并移动管口50使其与病人鼻腔通道12密封接合，从而使得鼻组件10与病人的鼻腔通道之间形成密封。随着气压增加，加到鼻腔下侧的力通过基座部分48增加。That is, the base portion 48 of such a structure can expand and contract to change the distance between the frame 16 and the nozzle 50 . The base portion 48 moves the nozzle 50 between a first position in which the nozzle 50 is proximate to the patient's nasal passage 12 and a second position in which the nozzle 50 moves into sealing engagement with the patient's nasal passage 12 . Specifically, in the uninflated condition, the nozzle 50 is spaced from or in light contact with the nasal passage 12 of the patient. When nasal assembly 10 is subjected to gas pressure, base portion 48 inflates and moves nozzle 50 into sealing engagement with the patient's nasal passage 12, thereby forming a seal between nasal assembly 10 and the patient's nasal passage. As the air pressure increases, the force applied to the underside of the nasal cavity through the base portion 48 increases.
基座部分48为框架16提供额外的表面面积或底部面积，其相应地对管口50提供额外的力以增加管口50的密封效率。即，基座部分48设置并定位以使管口50与病人的鼻子接触。病人鼻子上的力或压力与：(a)框架16和管口组件18中的压力；(b)基座部分48上额外的表面面积；和/或(c)从管口50或基座部分48，包括基座部分48的中心壁54和第一部分56，的材料和几何形状形成的预加负荷成比例。因而，基座部分48的表面积可以改变，例如，以改变加到病人鼻子上的力或压力。The base portion 48 provides additional surface area or bottom area for the frame 16 which in turn provides additional force against the spout 50 to increase the sealing efficiency of the spout 50 . That is, the base portion 48 is positioned and positioned so that the nozzle 50 contacts the patient's nose. The force or pressure on the patient's nose is related to: (a) the pressure in the frame 16 and nozzle assembly 18; (b) the additional surface area on the base portion 48; and/or (c) pressure from the nozzle 50 or base portion 48 , including the central wall 54 of the base portion 48 and the first portion 56 , are proportional to the preload formed by the material and geometry. Thus, the surface area of base portion 48 can be varied, for example, to vary the force or pressure applied to the patient's nose.
基座部分48的侧壁52可作为弹簧结构以通过管口50在病人脸部提供分力。该力可通过调整侧壁52的厚度进行适应性调节。另外，侧壁52的厚度可结合基座部分48提供的额外表面积进行改变。因而，基座部分48提供的力与气压一起提供与病人的鼻腔通道12的有效密封力。The side walls 52 of the base portion 48 may act as a spring structure to provide a force component through the nozzle 50 on the patient's face. This force can be adaptively adjusted by adjusting the thickness of the side wall 52 . Additionally, the thickness of sidewall 52 may vary in conjunction with the additional surface area provided by base portion 48 . Thus, the force provided by the base portion 48 together with the air pressure provides an effective sealing force with the nasal passage 12 of the patient.
基座部分48使得得到适当密封所需要的头带组件的张力减小。即，加到病人鼻子的密封力可由基座部分48、预加负荷和/或气压提供，而不是由头带组件20的张力提供。这改善病人的舒适度和密封特性。The base portion 48 reduces the tension in the headgear assembly required to achieve a proper seal. That is, the sealing force applied to the patient's nose may be provided by the base portion 48, preload and/or air pressure rather than by the tension of the headgear assembly 20. This improves patient comfort and sealing characteristics.
因此，在调整头带组件20时理想的是使管口50仅靠近或与病人的鼻子很轻微的接触。以这种方式，基座部分48实际不受压。使用时不需要充分接触而密封。Accordingly, it is desirable when adjusting the headgear assembly 20 that the nozzle 50 is only near or in very light contact with the patient's nose. In this way, the base portion 48 is virtually unpressurized. It does not need to be fully contacted and sealed when used.
基座部分48还提供框架16和管口50之间的去耦接头，因而允许鼻组件10与病人脸部之间相对地运动。结果，管口50可适应病人鼻子形状特征的各种小变化而不产生不适当的力，并且在使用时可解决鼻组件10相对于病人鼻子的小的运动，并保持有效密封。Base portion 48 also provides a decoupling joint between frame 16 and nozzle 50, thereby allowing relative movement between nasal assembly 10 and the patient's face. As a result, the nozzle 50 can accommodate small variations in the shape characteristics of a patient's nose without undue force, and can account for small movements of the nasal assembly 10 relative to the patient's nose during use and maintain an effective seal.
另外，连接组件22包括第一和第二连接部件24、26，使得管口50的位置易于相对于病人的鼻子调整。具体地说，病人可使框架16相对于头带组件20转动以调整管口50的位置。In addition, the connection assembly 22 includes first and second connection members 24, 26 such that the position of the nozzle 50 is easily adjusted relative to the patient's nose. Specifically, the patient may rotate the frame 16 relative to the headgear assembly 20 to adjust the position of the nozzle 50 .
另外，基座部分48不必是上述的单个基座形式，而可具有其它的结构。例如，基座部分48可以是两个和更多按序排列的基座部分的形式。In addition, the base portion 48 need not be in the form of a single base as described above, but may have other configurations. For example, base portion 48 may be in the form of two or more base portions arranged in sequence.
如图5和6所示，基座部分48的端部相互成一定角度以使得连接到其上的管口50相互成一定角度。这个角度，也可称作为翼角，可被调整以适应不同形状的病人的鼻子。例如，如图5和6所示的管口组件具有范围在135-155°的翼角，优选在大约145°，以适应基本平的鼻子(见图19)。或者，翼角的范围可在70-90°，优选在大约80°，以适应基本尖或陡削的鼻子(见图20)。但是，该翼角可以具有任何适当的尺寸以适应任何形状的鼻子。管口的移动有助于适合较陡的鼻子。As shown in Figures 5 and 6, the ends of the base portion 48 are angled relative to each other such that the nozzles 50 connected thereto are angled relative to each other. This angle, also known as the wing angle, can be adjusted to accommodate different shapes of patient's noses. For example, the nozzle assembly shown in Figures 5 and 6 has a wing angle in the range of 135-155°, preferably around 145°, to accommodate a substantially flat nose (see Figure 19). Alternatively, the wing angle may range from 70-90°, preferably around 80°, to accommodate a substantially pointed or steep nose (see Figure 20). However, the horns can be of any suitable size to accommodate any shape of nose. The movement of the nozzle helps to fit steeper noses.
如图21所示，管口50的密封区可从管口的大约一半高度以一角度延伸。在示范实施例中，管口50的高度约为9mm。但是，管口50可具有任何适合的高度并可提供任何适当的密封区。(若希望从该申请中删除图21请建议。)As shown in Figure 21, the sealing area of the nozzle 50 may extend at an angle from about half the height of the nozzle. In the exemplary embodiment, the height of the nozzle 50 is about 9 mm. However, the nozzle 50 can be of any suitable height and can provide any suitable sealing area. (Please suggest if you wish to remove Figure 21 from this application.)
管口50在基座部分48上相互间适当地隔开。隔开的距离基于管口50的尺寸和基座部分48的可用空间。The nozzles 50 are suitably spaced from each other on the base portion 48 . The separation distance is based on the size of the nozzle 50 and the space available in the base portion 48 .
管口50的尺寸基于病人鼻孔的周长。在一实施例中，椭圆比例可用于确定管口的几何形状(见图22)。例如，椭圆比例0.7(平均值+1标准差)可用于确定管口的几何形状。如图23所示，管口50的基主轴可通过测量鼻孔中心和上嘴唇的距离来确定。如图24所示，管口50的基短轴可通过管口之间最大的可用间隔来确定。但是，可采用任何其他适合的方法确定管口的尺寸。(若希望从该申请中删除图22-24请建议。)The size of the nozzle 50 is based on the circumference of the patient's nares. In one embodiment, ellipse proportions can be used to determine the geometry of the orifice (see Figure 22). For example, an ellipse scale of 0.7 (mean + 1 standard deviation) can be used to determine the geometry of the orifice. As shown in Figure 23, the base axis of the nozzle 50 can be determined by measuring the distance between the center of the nostril and the upper lip. As shown in Figure 24, the base minor axis of the orifices 50 can be determined by the largest available spacing between the orifices. However, any other suitable method of sizing the orifice may be used. (Please suggest if you wish to remove Figures 22-24 from this application.)
上述翼角、密封区、管口间的间隔以及管口的尺寸可被确定以适用于各种病人。而且，可提供不同尺寸的鼻组件，例如，小号，中号，大号，以适应各种不同大小的病人。但是，可采用任何其他的方法和方式以提供适合最大范围的病人的鼻组件。The aforementioned wing angles, sealing areas, spacing between orifices, and dimensions of the orifices can be tailored to suit a variety of patients. Also, nasal assemblies can be provided in different sizes, eg, small, medium, large, to accommodate a variety of different sized patients. However, any other method and manner may be used to provide a nasal assembly suitable for the widest range of patients.
本发明的一方面涉及一种可使密封与稳定力分离的鼻组件。即，鼻组件具有这种结构，使得保持鼻组件在病人脸部的稳定力与保持鼻组件与病人面部之间密封的密封力分开或至少更好地区别开。使用时，密封力作用于病人脸部更敏感的区域，如鼻子，而稳定力作用于病人脸部不太敏感的区域，如上嘴唇、颊部和病人头的后部。而且，稳定力趋于大于密封力。因而，鼻组件构造成使较大的稳定力与较小的密封力基本分离以改善病人的舒适度。One aspect of the invention relates to a nasal assembly that can decouple sealing from stabilizing forces. That is, the nasal assembly has a configuration such that the stabilizing forces that maintain the nasal assembly on the patient's face are separate, or at least better differentiated, from the sealing forces that maintain the seal between the nasal assembly and the patient's face. In use, the sealing force is applied to the more sensitive areas of the patient's face, such as the nose, while the stabilizing force is applied to less sensitive areas of the patient's face, such as the upper lip, cheeks, and the back of the patient's head. Also, the stabilizing force tends to be greater than the sealing force. Thus, the nasal assembly is configured to substantially separate the greater stabilizing force from the lesser sealing force to improve patient comfort.
具体地说，鼻组件的结构可使头带组件所加的稳定力分布到病人头的后部、病人的颊部和病人的上嘴唇以在使用时保持在鼻组件病人的脸部。该鼻组件包括使用时施加密封力到病人的鼻腔通道的管口组件。头带的特征使得密封和稳定力可基本分别调整。因而更高的稳定力不会同样地影响病人脸部较敏感的区域，如鼻子等。Specifically, the nose assembly is configured such that the stabilizing force applied by the headgear assembly is distributed to the back of the patient's head, the patient's cheeks, and the patient's upper lip to maintain the nose assembly on the patient's face during use. The nasal assembly includes a mouthpiece assembly that, in use, applies a sealing force to a patient's nasal passage. The features of the headgear allow the sealing and stabilizing forces to be adjusted substantially independently. The higher stabilizing force thus does not affect the more sensitive areas of the patient's face, such as the nose, in the same way.
本发明的另一方面涉及管口和施加力到病人脸部的基座部分之间的联系。具体地说，基座部分构造成加分力到病人脸部且管口构造成加分力到病人脸部。Another aspect of the invention relates to the connection between the nozzle and the base portion for applying force to the patient's face. Specifically, the base portion is configured to impart force to the patient's face and the nozzle is configured to impart force to the patient's face.
如图1所示，例如，基座部分可具有充分坚硬的结构以使得其加相对小的分力到病人脸部，也就是说，基座部分在通过气体加压时可以基本不膨胀或扩张。相反地，管口可以具有柔性的结构以致于其可对病人脸部提供相对较大的分力。即，管口50的第一部分56可作为一弹簧结构，例如，弹簧加载或弹性，以通过管口50在病人脸部加一分力。通过弹簧加载，意味着为了密封的目的，管口加一预定的力到病人的鼻腔密封区域。作为优选，在输入加压气体之前管口被预加载以为用户提供密封力。结果，基座部分和管口一起提供力以使得鼻组件与病人的鼻腔通道之间密封。As shown in Figure 1, for example, the base portion may have a sufficiently rigid structure such that it applies a relatively small force component to the patient's face, that is, the base portion may not expand or expand substantially when pressurized by gas. . Conversely, the nozzle may have a flexible structure such that it provides a relatively large force component to the patient's face. That is, the first portion 56 of the nozzle 50 may act as a spring structure, eg, spring-loaded or resilient, to apply a force through the nozzle 50 on the patient's face. By spring loading, it is meant that the nozzle applies a predetermined force to the patient's nasal cavity sealing area for sealing purposes. Preferably, the nozzle is preloaded prior to input of pressurized gas to provide a sealing force to the user. As a result, the base portion and the nozzle together provide a force to make a seal between the nasal assembly and the patient's nasal passage.
或者，基座部分可以具有柔性结构，使得其在膨胀时施加相对大的分力在病人的脸上。相反，管口可以具有较刚性的结构，使得其施加相对小的分力在病人的脸上。结果，基座部分和管口一起提供力以使得鼻组件与病人的鼻腔通道之间密封。Alternatively, the base portion may have a flexible structure such that it exerts a relatively large force component on the patient's face when inflated. In contrast, the nozzle may have a more rigid structure such that it exerts a relatively small force component on the patient's face. As a result, the base portion and the nozzle together provide a force to make a seal between the nasal assembly and the patient's nasal passage.
因此，管口组件的结构可以使得管口被弹簧加载或具有弹力以施加足够的分力用于密封。因而，基座部分可具有更坚硬的结构以施加较小的分力供密封。或者，管口组件可构造成使得基座部分可充分扩张以加足够的分力用以密封，而管口可具有更坚硬的结构以加较小的分力用以密封。或者，管口可以是基本刚性的，例如，为具体的用户定制的情况下。这些改变可与在先的实施例结合(相关的刚性基座部分和弹簧加载的(如预加载)管口)。在这种情况下，管口的底座的结构可提供可变的预加载量，以及管口的密封部分，优选为用户定制，可相对较硬。而且，该管口组件的结构可使得基座部分和管口提供基本相似的分力供密封。Accordingly, the construction of the nozzle assembly may be such that the nozzle is spring loaded or resilient to apply a sufficient force component for sealing. Thus, the base portion may have a stiffer structure to exert a smaller force component for sealing. Alternatively, the nozzle assembly can be configured such that the base portion can expand sufficiently to apply a sufficient force component to seal, while the nozzle can be of a more rigid structure to apply a smaller force component to seal. Alternatively, the nozzle may be substantially rigid, for example, where it is custom made for a particular user. These changes can be combined with the previous embodiments (relative rigid base portion and spring loaded (eg preloaded) nozzle). In this case, the configuration of the base of the nozzle may provide a variable amount of preload, and the sealing portion of the nozzle, preferably custom made, may be relatively stiff. Furthermore, the nozzle assembly is configured such that the base portion and the nozzle provide substantially similar force components for sealing.
第二示范实施例Second exemplary embodiment
图25至37示出了鼻组件，以201表示，的另一实施例。如图25至27所示，鼻组件210包括框架216和与框架216可拆卸地连接的管口组件218。头带组件220(见图37)可拆卸地安装在框架216上以使得框架216和管口组件218在病人面部保持在需要调整到的位置。进气导管274(见图36和37)也可拆卸地连接在框架216上以输送呼吸气体到框架216和管口组件218供病人呼吸。头带组件220和进气导管274通过进气导管和头带连接组件222可拆卸地连接在框架216上。该连接组件222包括设置在框架216上的第一连接部件224和适于与第一连接部件224可拆卸地连接的第二连接部件226。该第二连接部件226可拆卸地与头带组件220及进气导管274连接，下面将进一步讨论。Figures 25 to 37 illustrate another embodiment of a nasal assembly, indicated at 201 . As shown in FIGS. 25-27 , nose assembly 210 includes a frame 216 and a nozzle assembly 218 removably connected to frame 216 . Headgear assembly 220 (see FIG. 37 ) is removably mounted on frame 216 so that frame 216 and nozzle assembly 218 remain in the desired adjusted position on the patient's face. An intake conduit 274 (see FIGS. 36 and 37 ) is also removably attached to frame 216 to deliver breathing gas to frame 216 and nozzle assembly 218 for breathing by the patient. The headband assembly 220 and the air intake duct 274 are detachably connected to the frame 216 via the air intake duct and headband connection assembly 222 . The connection assembly 222 includes a first connection part 224 disposed on the frame 216 and a second connection part 226 adapted to be detachably connected to the first connection part 224 . The second connecting member 226 is removably connected to the headgear assembly 220 and the air intake conduit 274, as will be discussed further below.
如图28和29所示，框架216包括主体228，其提供一个可容纳管口组件218的中心开口230。框架216还包括设置在主体228各侧面的侧框架构件232。各侧框架构件232包括与其形成整体的第一连接部件224。第一连接部件224为在其内表面具有凹槽266的导管264的形式。该框架216还包括一系列开口278以清除CO2。As shown in FIGS. 28 and 29 , frame 216 includes a body 228 that provides a central opening 230 that receives nozzle assembly 218 . The frame 216 also includes side frame members 232 disposed on each side of the main body 228 . Each side frame member 232 includes a first connection member 224 integrally formed therewith. The first connection part 224 is in the form of a conduit 264 having a groove 266 on its inner surface. The frame 216 also includes a series of openings 278 to removeCO2 .
如图25-27和30-31所示，管口组件218形成包括主体219和相对的末端部分221(图中仅示出了管口组件218的一半)的导管。如图27所示，末端部分221伸展到侧框架构件232上方，使主体219覆盖框架216的主体228和中心开口230。当管口组件218安装到框架216上时，框架216给相对柔性的管口组件218增加硬度。As shown in Figures 25-27 and 30-31, the nozzle assembly 218 forms a conduit including a body 219 and an opposing end portion 221 (only one half of the nozzle assembly 218 is shown). As shown in FIG. 27 , end portion 221 extends over side frame members 232 such that body 219 covers body 228 and central opening 230 of frame 216 . Frame 216 adds rigidity to relatively flexible nozzle assembly 218 when nozzle assembly 218 is mounted to frame 216 .
管口组件218的主体219包括角撑部件248和连接其上的一对管口250。管口250可以类似于上述管口50的方式设计并架构。管口组件的主体219还包括与设置在框架216上用于排放CO2的系列开口278成直线排列的系列开口223。The body 219 of the nozzle assembly 218 includes a gusset member 248 and a pair of nozzles 250 connected thereto. Nozzle 250 may be designed and constructed in a manner similar to nozzle 50 described above. The body 219 of the nozzle assembly also includes a series of openings 223 aligned with a series of openings 278 provided on the frame 216 for discharging CO2 .
如图32-34所示，第二连接部件226包括具有前面部分260和后面部分262的主体。该前面部分260包括若干有回弹力的柔性臂238，其可沿径向向内和向外伸缩。各臂238在其自由端提供肋状部分240。使用时，该若干臂238的肋状部分240适于与第一连接部件224的凹槽266啮合，以将第一连接部件224和第二连接部件226相互结合。与上述连接组件22相反，连接组件222不提供指引段。因而第二连接部件226可相对于第一连接部件224转动以不定量设置管口250与病人的护鼻通道的对准。例如，这种设置可通过摩擦力锁定。As shown in FIGS. 32-34 , the second connection member 226 includes a body having a front portion 260 and a rear portion 262 . The front portion 260 includes a number of resiliently flexible arms 238 that are retractable radially inwardly and outwardly. Each arm 238 provides a ribbed portion 240 at its free end. In use, the ribbed portions 240 of the plurality of arms 238 are adapted to engage the grooves 266 of the first connecting member 224 to engage the first connecting member 224 and the second connecting member 226 with each other. In contrast to the connection assembly 22 described above, the connection assembly 222 does not provide a guide segment. The second connecting member 226 is thus rotatable relative to the first connecting member 224 to invariably set the alignment of the nozzle 250 with the nasal passage of the patient. For example, this arrangement can be locked by friction.
第二连接部件226的后面部分262包括横杆270，其形成供头带组件220的带可穿过并可拆卸地连接的开口。该后面部分262还提供一对导管272以用于连接到传送呼吸气体到框架216和管口组件218的进气导管。The rear portion 262 of the second connection member 226 includes a crossbar 270 that forms an opening through which the straps of the headgear assembly 220 may pass and be detachably connected. The rear portion 262 also provides a pair of conduits 272 for connection to an intake conduit that delivers breathing gas to the frame 216 and nozzle assembly 218 .
如图36所示，鼻组件210包括一对进气导管274(图36中只能看到一个进气导管274)。该对进气导管274的第一端连接到与框架216相连接的各第二连接部件226。该对导管274的第二端连接到提供加压呼吸气体的气压源。如图36和37所示，该对进气导管274路径向上延伸到病人头部上方。但是，该对进气导管274可以任何适宜的方式设定路径，如向下从病人的颌下延伸的路径。As shown in FIG. 36, the nasal assembly 210 includes a pair of air intake conduits 274 (only one intake conduit 274 is visible in FIG. 36). First ends of the pair of intake ducts 274 are connected to the respective second connecting members 226 connected to the frame 216 . The second ends of the pair of conduits 274 are connected to a source of air pressure that provides pressurized breathing gas. As shown in Figures 36 and 37, the pair of inlet conduits 274 are routed upwardly above the patient's head. However, the pair of intake conduits 274 may be routed in any suitable manner, such as a path extending downwardly from the patient's jaw.
其结果，已加压的气体可通过该对进气导管274输入框架216和管口组件218，并通过管口250供病人呼吸。As a result, pressurized gas can be delivered to the frame 216 and nozzle assembly 218 through the pair of inlet conduits 274 and breathed by the patient through the nozzle 250 .
图35示出了将该对进气导管274的第二端与气压源相互连接的气流发生器连接器284。具体地说，该气流发生器连接器284包括与该对进气导管274之一相连接的一对第一导管和与该对进气导管274中的另一导管相连接的一对第二导管288。该气流发生器连接器284包括与连接到加压气体、空气或流体源的导管相连接的第三导管290。该第三连接器290可以包括旋转接头或能变形的连接机构以允许气流发生器连接器284和与加压源连接的导管之间相对运动。另外，第三连接器290可包括球窝接头以使得当第三连接器290在过头配置中位于病人头顶上时，管的拉伸最小。Figure 35 shows an airflow generator connector 284 interconnecting the second ends of the pair of intake conduits 274 with a source of air pressure. Specifically, the air flow generator connector 284 includes a pair of first conduits connected to one of the pair of intake conduits 274 and a pair of second conduits connected to the other conduit of the pair of intake conduits 274 288. The flow generator connector 284 includes a third conduit 290 that connects to a conduit connected to a source of pressurized gas, air or fluid. The third connector 290 may include a swivel joint or deformable connection mechanism to allow relative movement between the flow generator connector 284 and a conduit connected to a pressurized source. Additionally, the third connector 290 may include a ball joint to minimize tube stretching when the third connector 290 is positioned on top of the patient's head in the overhead configuration.
在示范的实施例中，进气导管274提供具有中心支撑壁的双气流通道以防止扭结和堵塞。但是，该导管274连接部件224，226以及连接器284可提供一条气流通道或两个以上气流通道。In the exemplary embodiment, intake conduit 274 provides dual air flow channels with a central support wall to prevent kinks and clogging. However, the conduit 274 connecting components 224, 226 and the connector 284 may provide one air flow channel or more than two air flow channels.
头带组件220可拆卸地或固定地连接到与框架216连接的第二连接部件226以使框架216和管口组件218在病人脸部保持在所希望调整的位置。如图37所示，头带组件220包括两个侧面部分292(图37中只能看到一个侧面部分292)，使后面部分294与该侧面部分292连接。各侧面部分292包括侧带296。与该两个侧面部分292相互连接的后面部分294，包括越过病人头顶的上带298和绕过病人头后部的后带299。上带298和后带299可进行适应调整且可以是单根带或环圈。而且，头带组件可固定地连接到框架上。The headgear assembly 220 is removably or fixedly attached to a second attachment member 226 attached to the frame 216 to maintain the frame 216 and nozzle assembly 218 in a desired adjusted position on the patient's face. As shown in FIG. 37, the headgear assembly 220 includes two side portions 292 (only one side portion 292 is visible in FIG. 37) to which a rear portion 294 is attached. Each side portion 292 includes a side strap 296 . A rear portion 294 interconnecting the two side portions 292 includes an upper strap 298 that goes over the top of the patient's head and a rear strap 299 that goes around the back of the patient's head. The upper strap 298 and the rear strap 299 are adaptable and can be a single strap or a loop. Also, the headgear assembly may be fixedly attached to the frame.
各侧带296具有减小的宽度，使其可卷绕设置在第二连接部件226上的横杆270。可采用挂钩和环形材料，如帮助该侧带296固定到各横杆270。因而，侧带296可以相对于第二连接部件226进行适应性调整。Each side strap 296 has a reduced width to allow it to wrap around the crossbar 270 disposed on the second connecting member 226 . Hook and loop materials are available such as Aids in securing the side straps 296 to each rail 270 . Thus, the side straps 296 may be adaptively adjusted relative to the second attachment member 226 .
开口或带扣可设置在侧带296上使得上带298和后带299与其结合。但是，头带组件220可包括多条带以支持鼻组件210在病人头上。或者，头带组件220可做成一个整体结构。Openings or buckles may be provided on the side straps 296 such that the upper strap 298 and the rear strap 299 engage therewith. However, headgear assembly 220 may include multiple straps to support nasal assembly 210 on the patient's head. Alternatively, headgear assembly 220 may be formed as a unitary structure.
如图37所示，头带组件220包括定位带291以保持气流发生器连接器284和进气导管274位于病人头顶的适当位置。头带组件220还包括定位叉293以在进气导管274向上延伸跨过头顶时保持进气导管274靠近头带组件220。As shown in FIG. 37, the headgear assembly 220 includes a positioning strap 291 to hold the flow generator connector 284 and the intake conduit 274 in place on the top of the patient's head. The headgear assembly 220 also includes alignment prongs 293 to hold the air intake conduit 274 close to the headgear assembly 220 as the air intake conduit 274 extends upward across the crown of the head.
与如上所述的鼻组件10类似，角撑部件248与气压一起产生的力提供对病人鼻腔通道12的有效的密封力。因而，角撑部件248使获得适当得密封所需的头带组件的张力减小。另外，管口250的位置可以相对于病人鼻子调整以改善病人的舒适度。Similar to the nasal assembly 10 described above, the force generated by the gusset members 248 in conjunction with the air pressure provides an effective sealing force against the nasal passage 12 of the patient. Thus, the gussets 248 reduce the tension in the headgear assembly needed to achieve a proper seal. Additionally, the position of the nozzle 250 can be adjusted relative to the patient's nose to improve patient comfort.
如图25所示，例如，角撑部件248具有柔性的结构，以致于在膨胀时在病人脸部加相对较大的分力。相反地，管口具有更坚硬的结构以致于其在病人脸部只加相对较小的力。即，管口的第一部分可具有较小的弹簧负载以通过管口在病人脸部提供相对较小的力。结果，角撑部件和管口一起产生用于提供鼻组件和病人鼻腔通道之间的密封的力。As shown in FIG. 25, for example, the gusset members 248 are of a flexible construction so as to exert a relatively large force component on the patient's face when inflated. Conversely, the nozzle has a more rigid structure so that it exerts relatively little force on the patient's face. That is, the first portion of the nozzle may have a lower spring load to provide relatively less force through the nozzle on the patient's face. As a result, the gusset and the nozzle together create a force for providing a seal between the nasal assembly and the patient's nasal passage.
第三示范实施例Third Exemplary Embodiment
图38至51示出了以310表示的鼻组件的另一实施例。如图38、39和43所示，鼻组件310包括框架316和与框架316可拆卸地连接的管口组件318。头带组件320可拆卸地连接在框架316上以使得框架316和管口组件318在病人面部保持在需要调整到的位置。进气导管374也可拆卸地连接在框架316上以输送呼吸气体到框架316和管口组件318供病人呼吸。头带组件320和进气导管374通过进气导管和头带连接组件322可拆卸地连接到框架316上。该连接组件322包括设置在框架316上的第一连接部件324和适于与第一连接部件324可拆卸地连接的第二连接部件326。该第二连接部件326可拆卸地与头带组件320及进气导管374连接，下面将进一步讨论。Another embodiment of a nasal assembly, generally indicated at 310, is shown in FIGS. 38-51. As shown in FIGS. 38 , 39 and 43 , nose assembly 310 includes a frame 316 and a nozzle assembly 318 removably connected to frame 316 . The headgear assembly 320 is removably attached to the frame 316 so that the frame 316 and nozzle assembly 318 remain in the desired adjusted position on the patient's face. Inlet conduit 374 is also removably connected to frame 316 to deliver breathing gas to frame 316 and nozzle assembly 318 for breathing by the patient. Headgear assembly 320 and air intake conduit 374 are detachably connected to frame 316 via intake conduit and headgear connection assembly 322 . The connection assembly 322 includes a first connection part 324 disposed on the frame 316 and a second connection part 326 adapted to be detachably connected to the first connection part 324 . The second connecting member 326 is removably connected to the headgear assembly 320 and the air intake conduit 374, as will be discussed further below.
如图40所示，框架316包括主体328，其提供一个可容纳管口组件318的中心开口330。框架316还包括设置在主体328各侧面的侧框架构件232。各侧框架构件332包括与其形成整体的第一连接部件324。第一连接部件324为在其内表面具有凹槽366(见图43)的导管364的形式。As shown in FIG. 40 , frame 316 includes a body 328 that provides a central opening 330 that receives nozzle assembly 318 . The frame 316 also includes side frame members 232 disposed on each side of the main body 328 . Each side frame member 332 includes a first connection member 324 integrally formed therewith. The first connecting member 324 is in the form of a conduit 364 having a groove 366 (see FIG. 43 ) in its inner surface.
如图41所示，管口组件318形成包括主体319和相对的末端部分321的导管。如图42、43和44所示，末端部分321伸展到框架316的侧框架构件332上方，使主体319覆盖框架316的主体328和中心开口330。当管口组件318安装到框架316上时，框架316和管口组件318形成传送呼吸气体到病人的鼻子的导管。另外，框架316给相对柔性的管口组件318增加硬度或结构上形成整体。As shown in FIG. 41 , the nozzle assembly 318 forms a conduit including a main body 319 and an opposing end portion 321 . As shown in FIGS. 42 , 43 and 44 , the end portion 321 extends over the side frame members 332 of the frame 316 such that the main body 319 covers the main body 328 and the central opening 330 of the frame 316 . When nozzle assembly 318 is mounted to frame 316, frame 316 and nozzle assembly 318 form a conduit for delivering breathing gases to the patient's nose. In addition, the frame 316 adds rigidity or structural integrity to the relatively flexible nozzle assembly 318 .
如图43和44所示，管口组件318的主体319包括基座部件348和连接在其上的一对管口350。管口350可以类似于上述管口50的方式设计并架构。管口组件318的主体319还包括用于排放CO2的一个或多个开口323(如，见图39和41)。As shown in FIGS. 43 and 44, the body 319 of the nozzle assembly 318 includes a base member 348 and a pair of nozzles 350 attached thereto. Nozzle 350 may be designed and constructed in a manner similar to nozzle 50 described above. The body 319 of the nozzle assembly 318 also includes one or more openings 323 for venting CO2 (eg, see FIGS. 39 and 41 ).
如图38B和43所示，第二连接部件326包括具有前面部分360和后面部分362的主体。该前面部分360包括肋状部分340。使用时，肋状部分340适于与第一连接部件324的凹槽366啮合，以将第一和第二连接部件324、326相互结合。与上述连接组件222类似，第二连接部件326可相对于第一连接部件324转动以不定量的设置调整管口350与病人的鼻腔通道对准。例如，这种设置可任意地通过摩擦力锁定。As shown in FIGS. 38B and 43 , the second connection member 326 includes a body having a front portion 360 and a rear portion 362 . The front portion 360 includes a ribbed portion 340 . In use, the ribbed portion 340 is adapted to engage the groove 366 of the first connecting member 324 to engage the first and second connecting members 324, 326 with each other. Similar to the connection assembly 222 described above, the second connection member 326 is rotatable relative to the first connection member 324 to adjust the alignment of the nozzle 350 with the patient's nasal passage in an indeterminate setting. Such an arrangement can optionally be locked by friction, for example.
如图38和38B所示，第二连接部件326的后面部分362包括开口370，可供头带组件320的带穿过并可拆卸地连接。如图38B所示，该后面部分362还提供一对导管372以用于连接到传送呼吸气体到框架316和管口组件318的进气导管。As shown in FIGS. 38 and 38B , the rear portion 362 of the second attachment member 326 includes an opening 370 through which the straps of the headgear assembly 320 may pass and be removably attached. As shown in FIG. 38B , the rear portion 362 also provides a pair of conduits 372 for connection to an intake conduit that delivers breathing gas to the frame 316 and nozzle assembly 318 .
如图38、39和45所示，鼻组件310包括一对进气导管374。该对进气导管374的第一端连接到与框架316相连接的各第二连接部件326。该对导管374的第二端连接到提供加压呼吸气体的气压源。如图45所示，例如，第二连接部件326可相对于第一连接部件324转动以使得该对进气导管374的路径向上跨过病人头部或向下到病人的下颚下方。As shown in FIGS. 38 , 39 and 45 , nasal assembly 310 includes a pair of air intake conduits 374 . First ends of the pair of intake ducts 374 are connected to the respective second connecting members 326 connected to the frame 316 . The second ends of the pair of conduits 374 are connected to a source of air pressure that provides pressurized breathing gas. As shown in FIG. 45, for example, the second connecting member 326 may be rotated relative to the first connecting member 324 so that the pair of intake conduits 374 are routed upwardly across the patient's head or downwardly under the patient's chin.
其结果，加压的气体可通过该对进气导管374输入框架316和管口组件318，并通过管口350供病人呼吸。As a result, pressurized gas may be delivered through the pair of inlet conduits 374 into the frame 316 and nozzle assembly 318 and through the nozzle 350 for the patient to breathe.
图45、47和48示出了将该对进气导管374的第二端与气压源相互连接的角形连接器384。如图47所示，该连接器384可以包括与各进气导管374相连接的一对双导管386。或者，如图48所示，该气流发生器连接器384可包括与各进气导管374相连接的一对单导管386。双气流通道进气导管374的端部可以修改，如图48所示，以有助于与具有一对单导管386的连接器386进行连接。另外，如图47和48所示，进气导管374的端部可包括一系列脊状突起，与连接器384上设置的一系列脊状突起互锁，以使得进气导管374与连接器384可靠地连接。Figures 45, 47 and 48 show the angle connector 384 interconnecting the second ends of the pair of intake conduits 374 with a source of air pressure. As shown in FIG. 47 , the connector 384 may include a pair of dual conduits 386 connected to each intake conduit 374 . Alternatively, as shown in FIG. 48 , the flow generator connector 384 may include a pair of single conduits 386 connected to each intake conduit 374 . The ends of the dual flow passage inlet conduit 374 may be modified, as shown in FIG. 48 , to facilitate connection with a connector 386 having a pair of single conduits 386 . Additionally, as shown in FIGS. 47 and 48 , the end of the intake conduit 374 may include a series of ridges that interlock with a series of ridges provided on the connector 384 such that the intake conduit 374 and the connector 384 Connect reliably.
如图49所示，进气导管374提供具有中心支撑壁的双气流通道以防止扭结或闭塞，如，防变形，且易于连接。而且，进气导管可用较硬的材料制成，如较硬的硬质硅树脂，以防止扭结或闭塞。但是，该导管374、连接部件324，326以及连接器384可提供一条气流通道或两条以上气流通道。如图47B所示，进气导管374可挤压成形或相反制成一个整体。或者，如图48B所示，进气导管374可包括通过注射模塑法、共模压法或夹物模压形成的若干导管，并以任何适合的方式相互连接，例如，通过连接器和/或其他如粘合剂的紧固件，或者将整个组件模压成一体，从而可减少部件和降低复杂度。As shown in FIG. 49, the intake conduit 374 provides a dual airflow channel with a central support wall to prevent kinks or occlusions, eg, deformation resistance, and ease of connection. Also, the intake conduit may be made of a harder material, such as harder, rigid silicone, to prevent kinking or occlusion. However, the conduit 374, connecting members 324, 326, and connector 384 may provide one air flow path or more than two air flow paths. As shown in Fig. 47B, the inlet conduit 374 may be extruded or otherwise made in one piece. Alternatively, as shown in FIG. 48B, the intake conduit 374 may comprise several conduits formed by injection molding, co-molding, or insert molding and interconnected in any suitable manner, for example, by connectors and/or other Fasteners such as adhesives, or the entire assembly can be molded in one piece, reducing parts and complexity.
头带组件320可拆卸地连接到与框架316连接的第二连接部件326以使框架316和管口组件318在病人脸部保持在所希望调整的位置。如图38、39和45所示，头带组件320包括两个侧面部分392，使后面部分394与该侧面部分392连接。各侧面部分392包括侧带396。与该两个侧面部分392相互连接的后面部分394包括越过病人头顶的上带398和绕过病人头后部的后带399。如图45所示，后面部分394可包括第二后带387以增加稳定性。The headgear assembly 320 is removably attached to a second attachment member 326 attached to the frame 316 to maintain the frame 316 and nozzle assembly 318 in the desired adjusted position on the patient's face. As shown in FIGS. 38, 39 and 45, the headgear assembly 320 includes two side portions 392 to which a rear portion 394 is attached. Each side portion 392 includes a side strap 396 . A rear portion 394 interconnecting the two side portions 392 includes an upper strap 398 that goes over the top of the patient's head and a rear strap 399 that goes around the back of the patient's head. As shown in FIG. 45, the rear portion 394 may include a second rear strap 387 for added stability.
各侧带396具有减小的宽度，使其可卷绕设置在第二连接部件326的上开口370。可采用挂钩和环形材料，如帮助侧带396固定到各开口370。因而，侧带396可以相对于第二连接部件326进行适应性调整。Each side strap 396 has a reduced width so that it can be rolled around the upper opening 370 of the second connecting member 326 . Hook and loop materials are available such as Aids in securing the side straps 396 to each opening 370 . Thus, the side straps 396 may be adaptively adjusted relative to the second attachment member 326 .
在该示范实施例中，头带组件320做成一个整体结构。但是，头带组件320可包括适当设置的多条带以支持鼻组件310在病人头部上。如图45所示，头带组件320可包括固定带393以保持进气导管374向上越过病人头部。In the exemplary embodiment, headgear assembly 320 is formed as a unitary structure. However, headgear assembly 320 may include appropriately positioned multiple straps to support nasal assembly 310 on the patient's head. As shown in FIG. 45, the headgear assembly 320 may include a securing strap 393 to hold the intake conduit 374 up over the patient's head.
图50示出了要与病人鼻子14的鼻腔通道12接合的鼻组件310。图51示出了与病人的鼻腔通道12接合的鼻组件310。病人的上嘴唇接触管口组件318的硅树脂外表面以有助于鼻组件310保持在病人脸部适当的位置。FIG. 50 shows the nasal assembly 310 intended to engage the nasal passage 12 of the patient's nose 14 . Fig. 51 shows nasal assembly 310 engaged with nasal passage 12 of a patient. The patient's upper lip contacts the silicone outer surface of the nozzle assembly 318 to help keep the nasal assembly 310 in place on the patient's face.
与如上所述的鼻组件10类似，基座部分348与气压一起产生的力提供对病人鼻腔通道12的有效的密封力。因而，基座部分348使得获得适当的密封所需的头带组件的张力减小。而且，管口350的位置可以相对于病人鼻子调整以改善病人的舒适度。Similar to the nasal assembly 10 described above, the force generated by the base portion 348 in conjunction with the air pressure provides an effective sealing force against the nasal passage 12 of the patient. Thus, the base portion 348 allows for reduced headgear assembly tension required to obtain a proper seal. Also, the position of the nozzle 350 can be adjusted relative to the patient's nose to improve patient comfort.
如图43所示，例如，基座部分348具有柔性的结构，以致于在充气时在病人脸部加相对较大的分力。相反地，管口具有更坚硬的结构以致于其在病人脸部只能加相对较小的分力。即，管口的第一部分可具有较小的弹力负载以通过管口在病人脸部提供相对较小的分力。结果，基座部分和管口一起产生用于提供鼻组件和病人鼻腔通道之间的密封的力。As shown in FIG. 43, for example, the base portion 348 has a flexible configuration so that a relatively large force component is exerted on the patient's face when inflated. Conversely, the nozzle has a more rigid structure so that it exerts a relatively small force component on the patient's face. That is, the first portion of the nozzle may have a relatively small spring load to provide a relatively small force component through the nozzle on the patient's face. As a result, the base portion and the nozzle together create a force for providing a seal between the nasal assembly and the patient's nasal passage.
另外，基座部分348可在所需方向提供特定的力，例如，向内部有利于密封的力。基座部分348可在有些区域提供较大的移置以提供附加的力。Additionally, the base portion 348 can provide a specific force in a desired direction, eg, inwardly to facilitate sealing. Base portion 348 may provide greater displacement in some areas to provide additional force.
图46为当鼻组件装到病人头部时所产生的某些力的力图。例如，头带张力在病人脸部产生力而病人的鼻子和嘴唇在鼻组件310上产生力。(请建议是否要删除该图。)Figure 46 is a force diagram of some of the forces generated when the nasal assembly is fitted to a patient's head. For example, headgear tension creates forces on the patient's face and the patient's nose and lips create forces on nose assembly 310 . (Please suggest if the graph should be removed.)
第四示范实施例Fourth Exemplary Embodiment
图52至58示出了以410表示的鼻组件的另一实施例。如图52和53所示，鼻组件410包括框架416和与框架416可拆卸地连接的管口组件418。头带组件420可拆卸地连接到框架416上以使得框架416和管口组件418在病人面部保持在需要调整到的位置。进气导管474也可拆卸地安装在框架416上以输送呼吸气体到框架416和管口组件418供病人呼吸。头带组件420和进气导管474通过进气导管和头带连接组件422可拆卸地安装在框架416上。该连接组件422包括设置在框架416上的第一连接部件424(见图55和56)和适于与第一连接部件424可拆卸地连接的第二连接部件426。第二连接部件426可拆卸地或者固定地连接在头带组件420和进气导管474上，下面将进一步讨论。Another embodiment of a nasal assembly indicated at 410 is shown in FIGS. 52 to 58 . As shown in FIGS. 52 and 53 , nose assembly 410 includes a frame 416 and a nozzle assembly 418 removably connected to frame 416 . The headgear assembly 420 is removably attached to the frame 416 so that the frame 416 and nozzle assembly 418 remain in the desired adjusted position on the patient's face. Intake conduit 474 is also removably mounted on frame 416 to deliver breathing gas to frame 416 and nozzle assembly 418 for breathing by the patient. The headgear assembly 420 and air intake duct 474 are detachably mounted on the frame 416 via the intake duct and headgear connection assembly 422 . The connection assembly 422 includes a first connection part 424 (see FIGS. 55 and 56 ) disposed on the frame 416 and a second connection part 426 adapted to be detachably connected to the first connection part 424 . The second attachment member 426 is removably or fixedly attached to the headgear assembly 420 and the air intake conduit 474, as discussed further below.
如图52和54所示，框架416包括主体428，提供一个可容纳管口组件418的中心开口430。框架416还包括设置在主体428各侧面的侧框架构件432。各侧框架构件432包括与其形成整体的第一连接部件424。第一连接部件为横杆466的形式(见图55和56)。如图54所示，主体428包括形成中心开口430的缘446。As shown in FIGS. 52 and 54 , the frame 416 includes a main body 428 providing a central opening 430 for receiving the nozzle assembly 418 . The frame 416 also includes side frame members 432 disposed on each side of the main body 428 . Each side frame member 432 includes a first connection member 424 integrally formed therewith. The first connecting member is in the form of a cross bar 466 (see Figures 55 and 56). As shown in FIG. 54 , body 428 includes a rim 446 that defines central opening 430 .
如图54所示，管口组件418包括角撑部件448和与其连接的一对管口450。角撑部件448有侧壁452，用于与环绕框架416的开口430的缘446密封结合。例如，角撑部件448的侧壁452可以有凹槽，它和设置在框架416上的缘446上的各突起以搭扣形成互锁。然而，管口组件418可以用任何其他适当的方式可拆卸地安装在框架416上，例如摩擦配合。当管口组件418安装在框架416上时，管口组件418就和框架416一起形成一个导管，用于通过该对管口450将可呼吸的气体导向病人的鼻子。As shown in FIG. 54, the nozzle assembly 418 includes a gusset member 448 and a pair of nozzles 450 connected thereto. The gusset member 448 has side walls 452 for sealing engagement with the rim 446 surrounding the opening 430 of the frame 416 . For example, the side walls 452 of the gusset members 448 may have grooves that snap interlock with the respective protrusions provided on the rim 446 of the frame 416 . However, nozzle assembly 418 may be removably mounted to frame 416 in any other suitable manner, such as a friction fit. When the nozzle assembly 418 is mounted on the frame 416, the nozzle assembly 418 and the frame 416 together form a conduit for directing breathable gas through the pair of nozzles 450 to the patient's nose.
管口450可以用类似于上述管口50的方式设计和构造。框架416可以包括一个或者多个开口(没有显示)以排出CO2。Nozzle 450 may be designed and constructed in a manner similar to nozzle 50 described above. Frame 416 may include one or more openings (not shown) to ventCO2 .
如图55所示，第二连接部件426包括具有前面部分460和后面部分462的主体。前面部分460包括在其远端具有一个整体式突起463的一对臂部件461。在使用中，臂部件461受第一连接部件424的横杆466作用向内弯曲，直到臂部件461臂部件461向外折回到达操作位置，使得整体式突起463的肩部定位使第二连接部件426和第一连接部件424互锁(见图56)。As shown in FIG. 55 , the second connection member 426 includes a body having a front portion 460 and a rear portion 462 . Front portion 460 includes a pair of arm members 461 having an integral protrusion 463 at their distal ends. In use, the arm member 461 is bent inwardly by the crossbar 466 of the first connecting member 424 until the arm member 461 is folded back outwardly to the operative position so that the shoulder of the integral protrusion 463 is positioned so that the second connecting member 426 interlocks with the first connecting member 424 (see FIG. 56).
第二连接部件426的臂部件461可相对于第一连接部件424的横杆466旋转。如图55所示，臂部件461上具有突起465，能够和横杆466内表面的一系列凹槽选择性地相啮合以便提供相对于病人的鼻腔通道对准管口450的预定数目的设置。The arm part 461 of the second link part 426 is rotatable relative to the crossbar 466 of the first link part 424 . As shown in FIG. 55, arm member 461 has protrusions 465 selectively engageable with a series of grooves in the inner surface of crossbar 466 to provide a predetermined number of settings for aligning nozzles 450 with respect to the patient's nasal passages.
如图55所示，后面部分462具有用于连接到进气导管的一对导管472以输送可呼吸气体到框架416和管口组件418。第二连接部件426的后面部分462还包括横杆或是开口(没有示出)以便头带组件420的皮带穿过并可拆卸地连接。As shown in FIG. 55 , rear portion 462 has a pair of conduits 472 for connecting to an intake conduit for delivering breathable gas to frame 416 and nozzle assembly 418 . The rear portion 462 of the second connecting member 426 also includes a crossbar or opening (not shown) for the strap of the headgear assembly 420 to pass through and be detachably connected.
如图52和53所示，鼻组件410具有一对进气导管474。该对导管474的第一端连接到与框架416相连接的各第二连接部件426。该对导管474的第二端连接到提供加压的可呼吸气体的气压源。如图52所示，第二连接部件426可以相对于第一连接部件424转动以便，例如，使该对进气导管474路径向上越过病人头上或向下到下颚下面。As shown in FIGS. 52 and 53 , the nasal assembly 410 has a pair of air intake conduits 474 . First ends of the pair of conduits 474 are connected to respective second connection members 426 connected to the frame 416 . The second ends of the pair of conduits 474 are connected to an air pressure source that provides pressurized breathable gas. As shown in FIG. 52, the second connecting member 426 can be rotated relative to the first connecting member 424 to, for example, route the pair of intake conduits 474 up over the patient's head or down under the chin.
因此，加压气体可以通过该对进气导管474进入框架416和管口组件418，并通过管口450供病人呼吸。Accordingly, pressurized gas may enter the frame 416 and nozzle assembly 418 through the pair of intake conduits 474 and be breathed by the patient through the nozzle 450 .
图53显示说明了使该对进气导管474的第二端与气压源相互连接的气流发生器连接器484。Figure 53 shows an illustration of the flow generator connector 484 interconnecting the second ends of the pair of intake conduits 474 with a source of air pressure.
如图52所示，进气导管474提供双气流通道以防止钮结和利于连接。然而，该导管474、连接部件424，426、连接器484可以构造提供一个气流通道或者两个以上的气流通道。As shown in FIG. 52, the intake conduit 474 provides dual airflow channels to prevent kinks and facilitate connection. However, the conduit 474, connecting members 424, 426, and connector 484 can be configured to provide one airflow channel or more than two airflow channels.
头带组件420可拆卸地连接到与框架416连接的第二连接部件426以使得框架416和管口组件418在病人脸上保持在想要调整到的位置。如图52和53所示，头带组件420具有两个侧面部分492，使后面部分494连接侧面部分492。各侧面部分492包含侧带496。与两个侧面部分492互连的后面部分494包括越过病人头顶上方的上带498和绕过病人头部后方的后带499。然而，头带组件可以固定连接在框架上。The headgear assembly 420 is removably attached to a second attachment member 426 attached to the frame 416 such that the frame 416 and nozzle assembly 418 remain in the desired adjusted position on the patient's face. As shown in FIGS. 52 and 53 , the headgear assembly 420 has two side portions 492 with a rear portion 494 joining the side portions 492 . Each side portion 492 includes a side band 496 . A rear portion 494 interconnecting the two side portions 492 includes an upper strap 498 that passes over the top of the patient's head and a rear strap 499 that goes around the back of the patient's head. However, the headgear assembly may be fixedly attached to the frame.
各侧带496具有减少的宽度以便能够缠绕第二连接部件426上面的横杆或者开口。可以利用挂钩和环状物质，例如维可牢尼龙搭扣()来帮助侧带496固定到各横杆和开口。这样，侧带496可以相对于第二连接部件426来调整达到适当的安装。Each side strap 496 has a reduced width to be able to wrap around the rail or opening above the second connecting member 426 . Hooks and loops such as Velcro ( ) to help secure the side straps 496 to the rails and openings. In this way, the side straps 496 can be adjusted relative to the second attachment member 426 for proper fit.
在该示范实施例中，头带组件420构造为整体结构。然而，头带组件420可以包括多个适当安排的带来支撑鼻组件410在病人头上。如图52和53所示，头带组件420可以具有维持进气导管474向上越过病人头部的保持带493。In the exemplary embodiment, headgear assembly 420 is constructed as a unitary structure. However, headgear assembly 420 may include a plurality of suitably arranged straps to support nasal assembly 410 on the patient's head. As shown in Figures 52 and 53, the headgear assembly 420 may have a retention strap 493 that maintains the air intake conduit 474 upwardly over the patient's head.
图57和图58显示鼻组件410与病人鼻子的鼻腔通道12接合。和上面讨论过的鼻组件10类似，与空气压力一起的由角撑部件448提供的力为病人的鼻腔通道12提供有效的密封力。这样，角撑部件448减少获得适当的密封所需的头带组件的张力。同样，管口450的位置可以相对于用户的鼻子调整来提高病人的舒适度。57 and 58 show nasal assembly 410 engaged with nasal passage 12 of a patient's nose. Similar to the nasal assembly 10 discussed above, the force provided by the gusset 448 along with the air pressure provides an effective sealing force against the nasal passage 12 of the patient. In this way, the gussets 448 reduce the tension on the headgear assembly needed to achieve a proper seal. Likewise, the position of the nozzle 450 can be adjusted relative to the user's nose to improve patient comfort.
如图58所示，例如，角撑部件具有基本坚硬的结构所以在充气的时候它在病人脸上提供相对较小的分力。相反，管口具有柔软的结构所以它在病人脸上提供相对较大的分力。也就是说，管口的第一部分可以有相对较大的弹簧负载以通过管口在病人脸上施加分力。结果，角撑部件和管口一起提供力以在鼻组件和病人鼻腔通道之间密封。As shown in Fig. 58, for example, the gusset has a substantially rigid structure so that it provides a relatively small force component on the patient's face when inflated. In contrast, the nozzle has a flexible structure so it provides a relatively large force component on the patient's face. That is, the first portion of the nozzle may have a relatively large spring load to exert a force component through the nozzle on the patient's face. As a result, the gusset and the nozzle together provide a force to seal between the nasal assembly and the patient's nasal passage.
第五示范实施例Fifth exemplary embodiment
图59至85示出了以510表示的鼻组件的另一实施例。鼻组件510包括框架516和可拆卸地连接在框架516上的管口组件518。如图61所示，框架516包括一对第一连接部件524。根据图59所示，一对进气导管574被构造用来输送可呼吸气体进入框架516和管口组件518以供病人呼吸。可呼吸气体，比如，通过一对第二连接部件526和一对角形连接器542从进气导管574输送到框架516和管口组件518。第二连接部件526可拆卸地和可转动地连接在框架516上的各第一连接部件524上(图61)。角形连接器542连接或者定位在第二连接部件526和相应的进气导管574之间。头带组件520可拆卸地连接到一对第二连接部件526和/或角形连接器542上，以便框架516和管口组件518在病人面部保持在需要调整到的位置，下面将详细讨论。Another embodiment of a nasal assembly indicated at 510 is shown in FIGS. 59 to 85 . Nose assembly 510 includes a frame 516 and a nozzle assembly 518 removably attached to frame 516 . As shown in FIG. 61 , the frame 516 includes a pair of first connecting members 524 . As shown in FIG. 59, a pair of intake conduits 574 are configured to deliver breathable gas into frame 516 and nozzle assembly 518 for breathing by the patient. Breathable gas is delivered from intake conduit 574 to frame 516 and nozzle assembly 518 , eg, via a pair of second connection members 526 and a pair of angled connectors 542 . The second connecting members 526 are detachably and rotatably connected to the respective first connecting members 524 on the frame 516 (FIG. 61). The angled connector 542 is connected or positioned between the second connection member 526 and the corresponding intake conduit 574 . The headgear assembly 520 is removably connected to a pair of second attachment members 526 and/or angle connectors 542 so that the frame 516 and nozzle assembly 518 remain in the desired adjusted position on the patient's face, as discussed in more detail below.
如图61所示，框架516包括主体528和设置在主体528各侧面的侧框架构件532。各侧框架构件532具有和其形成整体的第一连接部件524。第一连接部件524为在其外表面具有环形凹槽566的导管564的形式。另外，主体528在其反面具有延长的通道565，各侧框架构件532具有环形通道567。通道565，567被构造用来容纳管口组件518的末端，下面将详细讨论。As shown in FIG. 61 , the frame 516 includes a main body 528 and side frame members 532 disposed on each side of the main body 528 . Each side frame member 532 has a first connection member 524 integral therewith. The first connection part 524 is in the form of a conduit 564 having an annular groove 566 on its outer surface. Additionally, the main body 528 has an elongated channel 565 on its reverse side and each side frame member 532 has an annular channel 567 . Channels 565, 567 are configured to receive the ends of nozzle assembly 518, discussed in more detail below.
如图61-65所示，管口组件518包括角撑板或基座部件548和安装在其上的一对管口550。管口518与框架516联接，使该对管口550构造成在使用时和病人的鼻子的鼻腔通道密封接合，并提供鼻组件510和病人的鼻腔通道之间的密封。管口550可以以上述的管口50相类似的方式设计和构造。同样，管口组件518包括一个或者多个开口549用来清除CO2。As shown in FIGS. 61-65, the nozzle assembly 518 includes a gusset or base member 548 and a pair of nozzles 550 mounted thereon. The nozzles 518 are coupled to the frame 516 such that the pair of nozzles 550 are configured, in use, to sealingly engage the nasal passages of the patient's nose and provide a seal between the nasal assembly 510 and the patient's nasal passages. The nozzle 550 may be designed and constructed in a similar manner to the nozzle 50 described above. Likewise, nozzle assembly 518 includes one or more openings 549 forCO2 removal.
图65A是图65所示的管口组件518的放大视图，管口组件优选通过该组件包括一般具有同样截面区域的上轮廓部分519。因此，组件一般地遵循面部线条从而不会从脸部突起，从而保持较低的轮廓。相似的是，图119示出了一个管口或衬垫组件604，从上面看一般地遵循面部轮廓。Figure 65A is an enlarged view of the nozzle assembly 518 shown in Figure 65, with the nozzle assembly preferably including an upper profile portion 519 generally having the same cross-sectional area. Thus, the components generally follow the facial lines so as not to protrude from the face, thereby maintaining a low profile. Similarly, Figure 119 shows a nozzle or cushion assembly 604 that generally follows the contours of the face when viewed from above.
图65A所示的管口组件518还具有一般地与脸部轮廓相匹配的下轮廓部分521，而且，管口组件518是关于轴A不对称的，与现有技术的对称面具相比能提供更好的配合。下轮廓521对有胡子的病人也是有用的。The nozzle assembly 518 shown in Figure 65A also has a lower profile portion 521 that generally matches the contours of the face, and the nozzle assembly 518 is asymmetric about axis A, providing Better fit. The lower profile 521 is also useful for bearded patients.
来自病人接口保持装置例如头带的力，通过管口550及下轮廓部分521传递到脸上。增加的总面积减少了单位面积上的力，来分散负荷。增加的总面积也帮助更好的固定病人接口。下轮廓部分521的形状可根据用户的具体要求定做。下轮廓部分521可以是刚性的，半刚性的，弹性的或它们的一些组合。脸部的上颌骨可以承受更大的压力而不会感到不舒适。Forces from the patient interface retaining device, such as a headgear, are transferred to the face through the nozzle 550 and the lower profile portion 521 . The increased total area reduces the force per unit area to spread the load. The increased overall area also assists in better securing the patient interface. The shape of the lower contour portion 521 can be customized according to the user's specific requirements. Lower profile portion 521 may be rigid, semi-rigid, elastic or some combination thereof. The upper jaw of the face can take more pressure without discomfort.
图65B示意性的说明了因为面积的增加而导致的压力分布，特别是，紧挨着鼻子下面的区域只有软组织和软骨。Figure 65B schematically illustrates the pressure distribution due to the increased area, in particular, the area immediately below the nose with only soft tissue and cartilage.
如果唯一接触的地方是紧靠着鼻子下面的地方(即：不包括上颌骨)，那么用最小的力将管口维持在适当的地方将会在F1方向需要合力。这将会弄歪鼻子并会导致不舒适。如果这样的带被拉紧了，它可能会从头的前方滑落。然而，当一些负载被上颌骨承担时(即，一些力加在鼻子下方，另一些加在上颌骨上)，合力的方向将会变成F2，负载被分散了。因为上颌骨不会移动，所以F2可以更高些也不会导致不舒适。这样一种布局可以更多地承受过度绷紧力。这样也能够更多的罩住后头部。If the only place of contact is immediately below the nose (ie: excluding the maxilla), then maintaining the nozzle in place with minimal force will require a resultant force in the F1 direction. This will crook the nose and cause discomfort. If such a strap is taut, it may slip off the front of the head. However, when some of the load is borne by the maxilla (ie, some forces are applied under the nose and some on the maxilla), the direction of the resultant force will become F2 and the load will be distributed. Since the upper jaw does not move, the F2 can be higher without causing discomfort. Such an arrangement is more resistant to excessive tension. This will also cover the back of the head more.
在本示范实施例中，管口组件518环绕主体528和框架516的各侧框架构件532，并通过夹子530固定到框架516上。在另一实施例中，衬垫可以象短袜一样拉到框架上。各侧框架构件532中形成环形通道567，且管口组件518的侧面部分536卷入通道567内。具体地说，如图61所示，管口组件518通常为具有纵向开口的末端开放的管状结构。这种构造使得管口组件518具有一对相对隔开的末端部分534和侧面部分536。当管口组件518联接在框架516上时，侧面部分536和相应的环形通道567内啮合并且末末端部分534和位于主体528的相对侧的相应的延长通道565内啮合，如图64和68所示。In the exemplary embodiment, nozzle assembly 518 surrounds main body 528 and each side frame member 532 of frame 516 and is secured to frame 516 by clips 530 . In another embodiment, the liner can be pulled over the frame like a sock. An annular channel 567 is formed in each side frame member 532 and the side portion 536 of the nozzle assembly 518 is rolled into the channel 567 . Specifically, as shown in FIG. 61, the nozzle assembly 518 is generally an open-ended tubular structure having a longitudinal opening. This configuration is such that the nozzle assembly 518 has a pair of oppositely spaced apart end portions 534 and side portions 536 . When the nozzle assembly 518 is coupled to the frame 516, the side portions 536 engage with corresponding annular passages 567 and the distal end portions 534 engage with corresponding elongate passages 565 on the opposite side of the main body 528, as shown in FIGS. 64 and 68. Show.
如图62至64和66所示，末端部分534被固定在框架516和夹子530之间。那就是说，末端部分534固定在相对的通道565的各凸缘和夹子530的凸缘之间。当管口组件518连接到框架516上时，管口组件518和框架516一起形成导管，通过该对管口550引导可呼吸气体进入病人的鼻子。As shown in FIGS. 62 to 64 and 66 , end portion 534 is secured between frame 516 and clip 530 . That is, end portion 534 is secured between respective flanges of opposing channels 565 and flanges of clip 530 . When nozzle assembly 518 is coupled to frame 516, nozzle assembly 518 and frame 516 together form a conduit through which pair of nozzles 550 direct breathable gas into the patient's nose.
夹子530可以以任何适合的方式与框架516及管口组件518相啮合。例如，如图62和70所示，夹子530可以滑到框架516上。还可以选择的是，夹子530可以和框架510通过搭扣配合进行啮合。Clip 530 may engage frame 516 and nozzle assembly 518 in any suitable manner. For example, clip 530 may be slid onto frame 516 as shown in FIGS. 62 and 70 . Alternatively, clip 530 may engage frame 510 with a snap fit.
如图59所示，框架516被固定到管口组件518，这样在使用时框架516离开病人的上嘴唇成一角度，这就使得夹子530的位置离开病人从而不会刺激病人的脸。同样，管口组件518可以形成轮廓以在使用时适应病人的中隔。As shown in Figure 59, the frame 516 is secured to the nozzle assembly 518 such that in use the frame 516 is angled away from the patient's upper lip, which allows the clip 530 to be positioned away from the patient so as not to irritate the patient's face. Likewise, the nozzle assembly 518 may be contoured to fit the patient's septum in use.
上述框架516和管口组件518的联结使得管口组件518能够很容易的从框架516上拆卸以方便对管口组件518的清洗。而且，管口组件518的结构允许接近管口组件518的内部以便清洗。该管口组件518的结构还便于生产。The connection between the frame 516 and the nozzle assembly 518 enables the nozzle assembly 518 to be easily disassembled from the frame 516 to facilitate cleaning of the nozzle assembly 518 . Furthermore, the structure of the nozzle assembly 518 allows access to the interior of the nozzle assembly 518 for cleaning. The construction of the nozzle assembly 518 also facilitates manufacture.
然而，管口组件518还可以用任何其他适当的方式可拆卸地连接在框架516上，例如，图67，69，和71说明了将管口组件连接在框架上的另一种方法。如图所示，框架616被构造为主体上没有通道，这样管口组件618环绕主体并且夹子630被固定在框架616的两个侧框架构件之间以保持管口组件618的末端部分。However, the nozzle assembly 518 may be removably attached to the frame 516 in any other suitable manner, for example, Figures 67, 69, and 71 illustrate another method of attaching the nozzle assembly to the frame. As shown, the frame 616 is configured without a channel in the body such that the nozzle assembly 618 surrounds the body and a clip 630 is secured between two side frame members of the frame 616 to retain the end portion of the nozzle assembly 618 .
如图72所示，第二连接部件526包括具有前面部分560和后面部分562的主体。邻近前面部分560有凹槽561。前面部分560包括环形肋状部分540(图73)。第二连接部件526的前面部分560延伸到相应的第一连接部件524的上面以进行过盈配合。同样，肋状部分540适于啮合到第一连接部件524的凹槽566内以使得第一连接部件524和第二连接部件526相互连接，如图73所示。第二连接部件526可以相对于第一连接部件524旋转，以不定量设置相对于病人的鼻腔通道调整管口550的对齐。例如，这种设置可以任意地通过摩擦力锁定。也就是说，这种可旋转的连接允许框架516相对于第二连接部件526旋转以便在使用中相对于病人的鼻子调整管口550的位置。As shown in FIG. 72 , the second connection member 526 includes a body having a front portion 560 and a rear portion 562 . Adjacent to the front portion 560 is a groove 561 . Front portion 560 includes annular ribbed portion 540 (FIG. 73). The front portion 560 of the second connection member 526 extends over the corresponding first connection member 524 for an interference fit. Likewise, the rib portion 540 is adapted to engage into the groove 566 of the first connecting member 524 such that the first connecting member 524 and the second connecting member 526 are interconnected, as shown in FIG. 73 . The second connection member 526 is rotatable relative to the first connection member 524 to adjust the alignment of the nozzle 550 relative to the nasal passage of the patient by an indeterminate setting. Such an arrangement can optionally be locked by friction, for example. That is, the rotatable connection allows the frame 516 to be rotated relative to the second connection member 526 to adjust the position of the nozzle 550 relative to the patient's nose in use.
第二连接部件526可以用硬度在肖氏硬度值约为50至60的硅树脂制成，这种硬度方便与框架516组装、旋转运动和密封。然而，第二连接部件526可以用任何其他合适的材料来构成并且可以是任何合适的硬度。The second connecting member 526 may be made of silicone with a hardness of about 50 to 60 Shore, which facilitates assembly with the frame 516, rotational movement and sealing. However, the second connection member 526 may be constructed of any other suitable material and may be of any suitable hardness.
各第二连接部件526也可以形成有这样的特征，那就是允许在角形连接器542和框架516之间作相对移动以有不同的正面宽度。在本示范实施例中，该特征是在第二角形连接器542中的折皱538。这一特征隔离了第二连接部件526和框架516的连接以防止脱离。这一特征也允许第二连接部件526可以弯曲从而缓冲管拉力。而且，第二连接部件526是柔性的不妨碍空气流。然而，该特征可以有其他的任何合适的结构以提供适应性。Each second connecting member 526 may also be formed with features that allow relative movement between angle connector 542 and frame 516 to have different frontal widths. In the exemplary embodiment, this feature is crease 538 in second angle connector 542 . This feature isolates the connection of the second connecting member 526 and the frame 516 to prevent disengagement. This feature also allows the second connecting member 526 to bend to buffer tube tension. Also, the second connection member 526 is flexible so as not to obstruct air flow. However, the feature may have any other suitable configuration to provide flexibility.
在本示范实施例中，各第二连接部件526都具有或者连接到与相应的进气导管574相连接的角形连接器542上(见图74-76)。第二连接部件526和角形连接器542可以形成一个整体单元。各第二连接部件526的后面部分562包括用来和角形连接器542连接的底部凹槽544形式的互锁(图73)。角形连接器542包括具有一个与底部凹槽544相啮合以把角形连接器542固定到第二连接部件526上肩部546的导管545，从连接前的分解图73可以确定。In the exemplary embodiment, each second connection member 526 has or is connected to an angle connector 542 connected to a corresponding air intake conduit 574 (see FIGS. 74-76 ). The second connecting member 526 and the angle connector 542 may form an integral unit. The rear portion 562 of each second connecting member 526 includes an interlock in the form of a bottom groove 544 for connecting with the angled connector 542 (FIG. 73). Angle connector 542 includes a conduit 545 that engages a bottom groove 544 to secure angle connector 542 to shoulder 546 on second connecting member 526, as can be determined from exploded view 73 prior to connection.
角形连接器542包括构造用来和相应的进气导管574相啮合的延长的连接器552。在本示范实施例中，延长的连接器552具有锥形的结构以方便连接。此外，连接器552被布置锲入进气导管574之间以便固定进气导管574。如图76所示，导管545和角形连接器542的延长连接器552相互呈大约80度角度。然而，导管545和延长连接器552之间的角度可以是任何其它适合的角度。Angle connector 542 includes an elongated connector 552 configured to mate with a corresponding intake conduit 574 . In this exemplary embodiment, the extended connector 552 has a tapered structure to facilitate connection. Furthermore, the connector 552 is arranged to wedge between the intake conduits 574 in order to secure the intake conduits 574 . As shown in FIG. 76, the conduit 545 and the extension connector 552 of the angled connector 542 are at an angle of approximately 80 degrees relative to each other. However, the angle between conduit 545 and extension connector 552 may be any other suitable angle.
图76A示出了另外一个和图60所示的面罩组件相似的面罩组件的实施例。图76B是图76A中的面罩组件的分解视图。图76A和76B中的轭状物580’与图60中所示的轭状物580稍微有些不同，那就是图76A和76B中的轭状物580’有着更加流线形的、更加时尚和/或更优化适用于头带组件的外形。另外，图76A中的第二连接部件526′和肘状连接器542′被构造成有助于期间地对准(或者防止失调)。特别的，如图76C所示，第二连接部件526’包括要容纳在肘状连接器542’的键槽或者凹槽542a中的突片526a。肘状连接器542’还包括容纳突片526A的尖部的脊沟542b。FIG. 76A shows another embodiment of a mask assembly similar to that shown in FIG. 60 . Figure 76B is an exploded view of the mask assembly of Figure 76A. The yoke 580' among Figures 76A and 76B is slightly different from the yoke 580 shown in Figure 60 in that the yoke 580' among Figures 76A and 76B has a more streamlined, stylish and/or Or more optimally suited to the shape of the headgear assembly. In addition, the second connection member 526' and the elbow connector 542' in Figure 76A are configured to facilitate periodic alignment (or prevent misalignment). In particular, as shown in FIG. 76C, the second connection member 526' includes a tab 526a to be received in a keyway or groove 542a of the elbow connector 542'. Elbow connector 542' also includes a ridge 542b that receives the tip of tab 526A.
回到图59，该对导管574的第一端被连接到各角形连接器542，该对导管574的第二端连接到与旋转接头590相连接的或者设置在旋转接头590上的气流发生器连接器584上，旋转接头590又和供应加压可呼吸气体的气压源相接。如图所示，角形连接器542规定了该对进气导管574路径向下到病人下颚下方。Returning to FIG. 59 , the first ends of the pair of conduits 574 are connected to the angled connectors 542 , and the second ends of the pair of conduits 574 are connected to the air flow generator connected to the swivel joint 590 or provided on the swivel joint 590 On connector 584, swivel joint 590 is in turn connected to a source of air pressure for supplying pressurized breathable gas. As shown, angled connectors 542 route the pair of intake conduits 574 down to the patient's lower jaw.
结果，加压气体可以通过该对进气导管574、角形连接器542、第二连接部件526、框架516和管口组件518，并通过管口550以供病人呼吸。As a result, pressurized gas may pass through the pair of inlet conduits 574, angled connector 542, second connecting member 526, frame 516, and nozzle assembly 518, and through nozzle 550 for the patient to breathe.
图77和78显示了被构造用来使得该对进气导管574的第二端和与气压源联通的旋转接头590相互连接的气流发生器连接器584。气流发生器连接器584包括构造用来与进气导管574之一相啮合的第一延长连接器586和构造用来与进气导管574的另一个相啮合的第二延长连接器588。在本示范实施例中，第一和第二延长连接器586、588具有锥形结构，比如，顶部形成角度以方便连接。此外，第一和第二延长连接器586、588被安排锲入期间的相应的进气导管574中以，比如，通过摩擦力固定相应的进气导管574。而且，气流发生器连接器584一般具有Y形形状，使得第一延长连接器586相对第二延长连接器588形成角度。气流发生器连接器584的Y形形状防止了和进气导管574的不正确连接并且帮助合并气流通道。如图59所示，旋转接头590可以连接在气流发生器连接器584上从而允许相对于气压源的相对运动。77 and 78 show the flow generator connector 584 configured to interconnect the second ends of the pair of intake conduits 574 and a swivel joint 590 in communication with a source of air pressure. Air flow generator connector 584 includes a first extension connector 586 configured to engage one of the intake conduits 574 and a second extension connector 588 configured to engage the other of the intake conduits 574 . In the exemplary embodiment, the first and second extension connectors 586, 588 have a tapered configuration, eg, the tops are angled to facilitate connection. Furthermore, the first and second extension connectors 586, 588 are arranged to wedge into the respective intake conduit 574 during the period to secure the respective intake conduit 574, eg, by friction. Also, the airflow generator connector 584 generally has a Y-shape such that the first extension connector 586 is angled relative to the second extension connector 588 . The Y-shape of the airflow generator connector 584 prevents improper connection with the intake conduit 574 and helps to merge the airflow passages. As shown in FIG. 59, a swivel joint 590 may be attached to the flow generator connector 584 to allow relative movement with respect to the source of air pressure.
如图79所示，各进气导管574包括多个通道。在本示范实施例中，各进气导管574被构造为提供双气流通道的管路来防止或者至少减少扭结和变形并方便了连接。但是，导管574、角形连接器542和连接器584可以构造用来提供一个气流通道或者两个以上的气流通道。进气导管574可以用硅树脂制成并具有大约为50的肖氏硬度值。然而，进气导管574可以用任何其它合适的材料制造并且可以具有任何合适的硬度。As shown in FIG. 79, each intake duct 574 includes a plurality of passages. In the exemplary embodiment, each intake conduit 574 is configured as a tubing providing dual airflow passages to prevent or at least reduce kinks and deformations and to facilitate connection. However, conduit 574, angle connector 542, and connector 584 may be configured to provide one airflow passage or more than two airflow passages. The intake conduit 574 may be made of silicone and have a hardness of about 50 Shore. However, intake conduit 574 may be fabricated from any other suitable material and may have any suitable hardness.
进气导管574被构造为产生较低的阻抗，在一个实施例中，进气导管574对于一个给定的流速产生的阻抗小于约3cmH2O。同样的，进气导管574有着较低的外形轮廓。如图79所示，各进气导管574的宽度大约为20毫米，高度大约为9.5毫米。然而，进气导管574可以有其它任一适合的形状、尺寸和结构。例如，进气导管574可以有着一个大致D形的横截面。20毫米宽的尺寸可以调整以改变阻抗。例如，如果当高度和压力保持常量的时候减小了了宽度，阻抗将会增加，因为横截面减小了。相反的，如果在宽度增加的时候保持高度和压力不变，阻抗将会减小。结果就是不用增加高度就可以减小阻抗，因此保持进气导管574为低的外形轮廓，这样他们就更少在压迫病人和/或不会不舒服的陷入病人的脸部或者皮肤中。空气传送通道的其他部件，比如角形连接器542，设计时考虑到降低阻抗。相反，具有圆形截面的进气导管或角形连接器的阻抗可以相似地通过增加导管的直径而降低，但是外形轮廓的增加也相应的增加了病人的不舒适，因为导管可能从病人脸部呈进一步向外的位置，和/或导管可能会压在病人的脸上，这会减少舒适度和顺应性。The intake conduit 574 is configured to produce a low impedance, in one embodiment, the intake conduit 574 presents a resistance of less than about3 cmH2O for a given flow rate. Likewise, intake duct 574 has a lower profile. As shown in FIG. 79, each intake duct 574 has a width of about 20 mm and a height of about 9.5 mm. However, intake conduit 574 may have any other suitable shape, size and configuration. For example, intake conduit 574 may have a generally D-shaped cross-section. The 20mm wide dimensions can be adjusted to change impedance. For example, if the width is reduced while the height and pressure are kept constant, the impedance will increase because the cross-section is reduced. Conversely, if the height and pressure are kept constant while the width is increased, the impedance will decrease. The result is that impedance can be reduced without increasing height, thus keeping the intake ducts 574 low in profile so that they are less pressing on the patient and/or do not dig uncomfortably into the patient's face or skin. Other components of the air delivery path, such as angled connectors 542, are designed with reduced impedance in mind. Conversely, the impedance of an inlet duct with a circular cross-section or an angled connector can be similarly reduced by increasing the diameter of the duct, but the increased profile also increases patient discomfort as the duct may emerge from the patient's face. Further outward positions, and/or the catheter may press against the patient's face, which reduces comfort and compliance.
头带组件520可拆卸地安装在第二连接部件526和角形连接器542上以便保持第二连接头526在框架516上。此外，头带组件520被构造用来传送管拉力到头带组件520或者框架516上，从而避免或减小管拉力加到管口组件的机会，那样可能会危及管口和病人的气道间的密封。The headgear assembly 520 is removably mounted on the second connection member 526 and the angle connector 542 to hold the second connection head 526 on the frame 516 . In addition, headgear assembly 520 is configured to transmit tube tension to headgear assembly 520 or frame 516, thereby avoiding or reducing the chance of tube tension being applied to the nozzle assembly, which could compromise the connection between the nozzle and the patient's airway. seal.
如图59和60所示，头带组件520包括两个侧面部分592，使后面部分594与侧面部分592连接。侧面部分包括侧带和头带轭状物580连接到各侧带。头带轭状物580发挥增强杆的作用以增加头带组件520的硬度。图59和60示出了稍有不同的轭状物的构造。在图59中，轭状物是一个至少覆盖了柔性带598，599的一部分部件以增加其刚度或者硬度。在图60中，轭状物580是一个半刚性层，例如塑料，它设置在，如缝在，头带带598和/或599上。图60中的轭状物可以根据需要的硬度或多或少地和皮带598和/或599一起延伸。图60中的轭状物580在图80-82上也有示出。后面部分594包括越过病人头顶的上带598和绕过病人头部后方的后带599。上带598被构造用来调整密封力，因为他们将框架516拉起在病人鼻子上。后带599被构造用来调整鼻组件510的稳定性，因为他们将框架516向后拉到病人上嘴唇上面的脸上。As shown in FIGS. 59 and 60 , the headgear assembly 520 includes two side portions 592 with a rear portion 594 connected to the side portions 592 . The side portions include side straps and head straps. A yoke 580 is attached to each side strap. The headgear yoke 580 acts as a reinforcing bar to increase the stiffness of the headgear assembly 520 . Figures 59 and 60 show slightly different yoke configurations. In Fig. 59, the yoke is a member that covers at least a portion of the flexible straps 598, 599 to increase their rigidity or rigidity. In FIG. 60, the yoke 580 is a semi-rigid layer, such as plastic, that is disposed on, such as sewn onto, the headgear straps 598 and/or 599. The yoke in Fig. 60 may extend with more or less straps 598 and/or 599 depending on the desired stiffness. The yoke 580 of Figure 60 is also shown in Figures 80-82. The rear portion 594 includes an upper strap 598 that goes over the top of the patient's head and a rear strap 599 that goes around the back of the patient's head. The upper straps 598 are configured to adjust the sealing force as they pull the frame 516 up over the patient's nose. The rear straps 599 are configured to adjust the stability of the nasal assembly 510 as they pull the frame 516 back onto the patient's face above the upper lip.
上带598通过头带扣570相互连接。头带扣570被构造允许对称调整头带组件520。特别是，如图83所示，头带扣570包括第一导锁部分571和第二导锁部分572。第一导锁部分571适于可拆卸和可调整地与从一个头带轭状物580延伸出的上带598的一根相连接，而第二导锁部分572适于可拆卸和可调整地与另一个头带轭状物580延伸出的上带598的另一根相连接。各上带598可以卷绕带扣570相关的导锁部分571，572的横杆，如图59所示。各导锁部分571，572上设置有调整片576以方便病人调整头带张力。此外头带扣570包括弧形面578以防止头带扣570和病人的头部相接触。后带599可以通过带扣相互连接(如同上带598)或者以其他适合的方式连接。The upper straps 598 are interconnected by head strap buckles 570 . Headgear buckle 570 is configured to allow symmetrical adjustment of headgear assembly 520 . In particular, as shown in FIG. 83 , the headband buckle 570 includes a first latch portion 571 and a second latch portion 572 . The first locking portion 571 is adapted to be detachably and adjustably connected to one of the upper straps 598 extending from a headband yoke 580, while the second locking portion 572 is adapted to be detachably and adjustably The other end of the upper strap 598 that extends from the other headgear yoke 580 is connected. Each upper strap 598 may wrap around the crossbar of the associated latch portion 571, 572 of the buckle 570, as shown in FIG. An adjustment piece 576 is provided on each guide lock portion 571, 572 to facilitate the patient to adjust the tension of the headgear. In addition, the headgear buckle 570 includes a curved surface 578 to prevent the headgear buckle 570 from contacting the patient's head. The rear straps 599 may be connected to each other by buckles (like the upper straps 598) or in other suitable manners.
头带组件520上的头带轭状物580包括与相应的第二连接部件526相连的保持部件581以便保持第二连接部件526在框架516上。在该示范实施例中，保持部件581呈环形并且环绕各第二连接部件526。如图73所示，环形保持部件581具有环形突起以便啮合在相应的第二连接部件526中的环形凹槽561内，以牢固地将第二连接部件526保持在框架516上。The headgear yoke 580 on the headgear assembly 520 includes a retaining member 581 connected to a corresponding second connecting member 526 for retaining the second connecting member 526 on the frame 516 . In this exemplary embodiment, the retaining member 581 is ring-shaped and surrounds each second connecting member 526 . As shown in FIG. 73 , the annular retaining member 581 has an annular protrusion to engage in an annular groove 561 in the corresponding second connecting member 526 to securely hold the second connecting member 526 on the frame 516 .
此外，该对保持部件581同第二连接部件526所提供的相应的凹槽561(图72)啮合以便将头带力传送到框架516。这就允许对头带组件520施加在框架516上的力进行更精确的调整。而且，头带扣570在中心定位于病人头部上以允许对称调整头带组件520从而调整施加到框架516上的头带力。In addition, the pair of retaining members 581 engage with corresponding grooves 561 ( FIG. 72 ) provided in the second connecting member 526 to transmit the headgear force to the frame 516 . This allows for a more precise adjustment of the force exerted by the headgear assembly 520 on the frame 516 . Also, the headgear buckle 570 is centrally positioned on the patient's head to allow symmetrical adjustment of the headgear assembly 520 to adjust the headgear force applied to the frame 516 .
第二连接部件526的角形连接器542和头带组件520可释放地互锁。特别是，角形连接器542包括第一锁定部件554(见图74B)，其可以和头带组件520的头带轭状物580上设置的第二锁定部件556(见图80)互锁。在此示范实施例中，第一锁定部件554是钩状部件以和第二锁定部件556上设置的横杆互锁，如图81和82所示。锁定部件是锥形的并被设计成保持低的姿势。The angled connectors 542 of the second connecting member 526 and the headgear assembly 520 releasably interlock. In particular, the angle connector 542 includes a first locking member 554 (see FIG. 74B ) that can interlock with a second locking member 556 (see FIG. 80 ) provided on the headgear yoke 580 of the headgear assembly 520 . In this exemplary embodiment, the first locking member 554 is a hook member to interlock with a crossbar provided on the second locking member 556, as shown in FIGS. 81 and 82 . The locking member is tapered and designed to maintain a low posture.
图84和85示出了与穿戴者鼻子的鼻腔通道结合的鼻组件510。如图84所示，鼻组件被构造为角形连接器角度设定为水平线下10度以避免鼻组件510和病人颊骨接触。此外，图84示出了夹持管口组件的裂口端的夹子530角度设定为向上和向外离开病人的嘴唇，以避免和病人的无意中的接触。该角度可以在10到90度的范围内，优选为20到60度或者30度左右。如图85所示，第二连接部件526和框架516大致成55度角。可以设置折皱538(图73)以伸缩(向内和向外)以适应患者面部宽度的不同。然而，上面所说的角度只是示范性的，鼻组件510可以被构造为适于患者的面部的任意角度。84 and 85 illustrate the nasal assembly 510 in combination with the nasal passage of the wearer's nose. As shown in Figure 84, the nasal assembly is configured with the angled connector angled at 10 degrees below horizontal to avoid contact between the nasal assembly 510 and the patient's cheekbone. Additionally, Figure 84 shows that the clip 530 gripping the split end of the nozzle assembly is angled upward and outward away from the patient's lips to avoid inadvertent contact with the patient. The angle may be in the range of 10 to 90 degrees, preferably 20 to 60 degrees or around 30 degrees. As shown in FIG. 85, the second connecting member 526 and the frame 516 are at an angle of approximately 55 degrees. Creases 538 (FIG. 73) can be configured to flex (inwardly and outwardly) to accommodate differences in patient facial width. However, the angles stated above are exemplary only, and the nasal assembly 510 may be configured to fit any angle on the patient's face.
和上述鼻组件类似，角撑板或者基座部件548的膨胀与头带张力一起对患者鼻腔通道提供有效的密封力。此外，管口550的弹力提供额外的密封力。Similar to the nasal assembly described above, expansion of the gusset or base member 548 in conjunction with headgear tension provides an effective sealing force against the patient's nasal passages. Additionally, the spring force of the nozzle 550 provides additional sealing force.
第六示范实施例Sixth exemplary embodiment
图86至88示出了构造用来给患者的鼻子14的鼻腔通道12的鼻孔12输送可呼吸气体的鼻组件10另外一个实施例(见图97A和97B)。该鼻组件10包括柔性导管16，角撑部件18，一对管口20，22和头带连接器25。柔性导管16具有适于容纳的加压可吸入气体源的部件和患者侧24。角撑部件18具有与柔性导管16的患者侧相连接的第一侧26和第二侧28。该对管口20，22各具有和角撑部件18的第二侧28相连接的第一部分30，和构造用来在使用中与患者鼻子14的鼻腔通道12密封啮合并提供鼻组件10和患者鼻腔通道12之间的密封的第二部分32(见图90)。头带连接器25连接柔性导管16到安置在患者头上的头带组件。角撑部件18被这样构造：它可以扩张或者收缩以改变导管16和管口对20，22之间的距离，下面将进一步讨论。86-88 illustrate another embodiment of a nasal assembly 10 configured to deliver breathable gas to the nostrils 12 of the nasal passage 12 of the patient's nose 14 (see FIGS. 97A and 97B ). The nasal assembly 10 includes a flexible conduit 16 , a gusset 18 , a pair of nozzles 20 , 22 and a headgear connector 25 . The flexible conduit 16 has components adapted to accommodate a source of pressurized breathable gas and a patient side 24 . The gusset member 18 has a first side 26 and a second side 28 connected to the patient side of the flexible conduit 16 . The pair of nozzles 20, 22 each have a first portion 30 connected to the second side 28 of the gusset 18, and are configured to, in use, sealingly engage the nasal passage 12 of the patient's nose 14 and provide the nasal assembly 10 and the patient Sealed second portion 32 between nasal passages 12 (see FIG. 90 ). Headgear connector 25 connects flexible conduit 16 to a headgear assembly placed on the patient's head. The gusset 18 is configured so that it can expand or contract to vary the distance between the conduit 16 and the nozzle pairs 20, 22, as discussed further below.
或者，角撑部件在倾向于不允许明显的扩张和收缩，如果有的话，的更刚性的结构中可以被取消。而是，如上述涉及其他主要示范实施例时所述的，管口可以被构造为和患者的鼻孔以某些程度的预张力(在使用面罩之前，比如，加压之前)相啮合，该预张力可以通过在管口的轴向或者纵向施压来实现。Alternatively, the gussets can be eliminated in a more rigid structure that tends not to allow significant expansion and contraction, if any. Rather, as described above with respect to the other primary exemplary embodiments, the nozzles may be configured to engage the patient's nostrils with some degree of pretension (before mask use, e.g., before pressurization) Tension can be achieved by applying axial or longitudinal pressure on the nozzle.
在本示范实施例中，柔性导管16包括中心导管34，一对通过相应入口连接器40，42与中心导管34相连的进气导管36，38，和相互连接进气导管36，38的Y形进气连接器44。Y形进气连接器44被构造用来连接到与气压源相连的导管上。气压源通过进气导管36，38和中心导管34供应加压的可吸入气体，进入角撑部件18，并进入管口20，22供患者呼吸。In the exemplary embodiment, flexible conduit 16 includes a central conduit 34, a pair of intake conduits 36, 38 connected to central conduit 34 by respective inlet connectors 40, 42, and a Y-shaped conduit interconnecting intake conduits 36, 38. Intake connector 44. The Y-shaped inlet connector 44 is configured to connect to a conduit connected to a source of air pressure. A source of air pressure supplies pressurized breathable gas through inlet conduits 36, 38 and central conduit 34, into gusset 18, and into mouthpieces 20, 22 for breathing by the patient.
如图89所示，中心导管34包括相互连接的上面部分46和下面部分48。各上面部分46和下面部分48包括弓形横截面，这样当它们以相应边连接在一起时就形成了导管。在本示范实施例中，上面部分46和下面部分48通过粘合剂固定地相互连接，例如，通过胶水。然而上面部分46和下面部分48可以通过任何其他适合的方式固定地相互连接，比如通过紧固件。或者，上面部分46和下面部分48可以可拆卸地相互连接，或者他们可以加工成一个整体部件。As shown in FIG. 89, the central guide tube 34 includes an upper portion 46 and a lower portion 48 that are interconnected. Each of the upper portion 46 and the lower portion 48 includes an arcuate cross-section such that when joined together at the respective sides, a conduit is formed. In the exemplary embodiment, upper portion 46 and lower portion 48 are fixedly connected to each other by an adhesive, for example, by glue. However, the upper portion 46 and the lower portion 48 may be fixedly connected to each other by any other suitable means, such as by fasteners. Alternatively, upper portion 46 and lower portion 48 may be detachably connected to each other, or they may be fabricated as one unitary piece.
如图86，88，90和92至95所示，上面部分46和下面部分48从上面看时一般为C形形状。特别是，各上面部分46和下面部分48包括一个延长的中心段50和弯曲的末端段52，54。然而，上面部分46和下面部分48可以为其他任意适合的形状，比如如图89所示的拉长形状。As shown in Figures 86, 88, 90 and 92 to 95, upper portion 46 and lower portion 48 are generally C-shaped when viewed from above. In particular, each upper portion 46 and lower portion 48 includes an elongated central section 50 and curved end sections 52,54. However, upper portion 46 and lower portion 48 may be of any other suitable shape, such as the elongated shape shown in FIG. 89 .
各弯曲的末端段52，54包括凹槽56，比如如图94所示。当上面部分和下面部分46，48相互连接时，凹槽56夹持相应的进口连接器40，42，这将进一步讨论。上面部分和下面部分46，48中至少一个包括一个抗压肋58以防止中心导管45形成变形，那样会阻止空气流通。在图89中，凹槽56设置在其相对端上。Each curved end section 52, 54 includes a groove 56, such as shown in FIG. The grooves 56 retain the respective inlet connectors 40, 42 when the upper and lower portions 46, 48 are interconnected, as will be discussed further. At least one of the upper and lower portions 46, 48 includes a compression rib 58 to prevent deformation of the central duct 45, which would prevent air flow. In Fig. 89, grooves 56 are provided on opposite ends thereof.
如图89所示，中心导管34的上面部分46包括开口60。作为可膨胀和可收缩的枕头的形式的角撑部件18，包括了形成其间的空间的第一侧或侧壁26和第二侧或者侧壁28。第一侧壁26连接在上面部分46上。第一侧壁26包括与上面部分46中的开口60相通的进气开口。第二侧壁28有一对出气开口。角撑部件18和中心导管34的上面部分46之间的连接是一种柔性连接，这就允许角撑部件18和中心导管34之间的相对运动以增加舒适感和适应患者的面部特征的变化。As shown in FIG. 89 , the upper portion 46 of the central guide tube 34 includes an opening 60 . Gusset member 18, in the form of an expandable and collapsible pillow, includes a first side or side wall 26 and a second side or side wall 28 forming a space therebetween. The first side wall 26 is connected to the upper portion 46 . The first side wall 26 includes an intake opening that communicates with an opening 60 in the upper portion 46 . The second side wall 28 has a pair of air outlet openings. The connection between the gusset member 18 and the upper portion 46 of the central guide tube 34 is a flexible connection, which allows relative movement between the gusset member 18 and the central guide tube 34 to increase comfort and accommodate changes in the patient's facial features. .
在本示范实施例中，角撑部件18为大致矩形形状。然而，角撑部件18可以为大致圆形或者具有圆形横截面，或者任何其他适合的形状，包括避开患者脸部敏感区域的形状，比如，有凹口的角撑形状防止和病人中隔的接触。In the exemplary embodiment, gusset members 18 are generally rectangular in shape. However, the gusset 18 may be generally circular or have a circular cross-section, or any other suitable shape, including shapes that avoid sensitive areas of the patient's face, for example, a notched gusset shape that prevents contact with the patient's septum. s contact.
该对管口20，22各具有连接角撑部件的第二侧壁28的第一部分30，与角撑部件上相应的出气开口相通。各管口20，22的第二部分32被构造在使用中和患者的鼻子14的鼻腔通道12密封啮合并提供鼻组件10和患者鼻腔通道12之间的密封。在本示范实施例中，管口20，22是鼻枕形式，其中第二部分32轮廓形成为一个部分密封在鼻孔的下方而另一部分在使用时进入患者鼻子的鼻腔通道(比如，锥形，圆锥体形，截头中空圆锥形等等)。然而，管口20，22可以为例如，鼻叉、鼻套管或鼻喷形状，并且可以以任何适合的方式和鼻腔通道密封接合。例如，管口20，22可以密封在鼻腔通道内，靠着鼻腔通道，环绕着鼻腔通道，或者其中几个方式的联合。管口20，22可以包括波纹形的或者柔性的部分，这样允许管口20，22相对于角撑部件18和中心导管34移动。管口20，22轮廓可以被加工以与病人鼻子14的内部轮廓匹配。The pair of nozzles 20, 22 each have a first portion 30 connected to the second side wall 28 of the gusset, communicating with a corresponding outlet opening in the gusset. The second portion 32 of each nozzle 20, 22 is configured in use to sealingly engage the nasal passage 12 of the patient's nose 14 and provide a seal between the nasal assembly 10 and the nasal passage 12 of the patient. In the exemplary embodiment, the nozzles 20, 22 are in the form of nasal pillows, wherein the second portion 32 is contoured so that one portion seals under the nostrils and the other portion enters the nasal passage of the patient's nose in use (e.g., conical, conical, truncated hollow conical, etc.). However, the nozzles 20, 22 may be in the shape of, for example, nasal prongs, nasal cannula, or nasal sprays, and may sealingly engage the nasal passages in any suitable manner. For example, the nozzles 20, 22 may seal within the nasal passage, against the nasal passage, around the nasal passage, or a combination thereof. The nozzles 20 , 22 may include corrugated or flexible portions that allow the nozzles 20 , 22 to move relative to the gusset 18 and the central conduit 34 . The nozzles 20 , 22 may be contoured to match the internal contours of the patient's nose 14 .
在一个实施例中，鼻组件使用患者定制的管口，其可以可拆卸地安装在角撑部件上。在一优选形式中，管口用可以充分弯曲的聚乙烯材料来构造，比如：硅树脂弹性体。通过首先现场或遥控扫描患者的鼻子，然后使用这些数据去生产接触面，比如：制模，独特的管口能够被制造以和各患者鼻子相匹配。可以使用不接触的方法或者接触的方法来进行扫描。不接触的方法，例如，照相，或是通过探针进行身体接触或是通过收集鼻孔内或想要接触的内表面的内部印模。一旦一对适合的管口被制出，他们被送给用户以配装给患者。预形成或定做的形状的优点是截面积可以最大以减小流阻。In one embodiment, the nasal assembly uses a patient-customized nozzle that can be removably mounted on the gusset. In a preferred form, the nozzle is constructed of a substantially flexible polyethylene material, such as a silicone elastomer. By first scanning a patient's nose on-site or remotely, and then using this data to produce contact surfaces such as molding, unique nozzles can be fabricated to fit each patient's nose. Scanning can be performed using a non-contact method or a contact method. Non-contact methods, eg, photography, or physical contact with a probe or by taking internal impressions of the nostrils or inner surfaces that are intended to be contacted. Once a suitable pair of nozzles is made, they are sent to the user for fitting to the patient. An advantage of pre-formed or custom shapes is that the cross-sectional area can be maximized to reduce flow resistance.
此外，预形成形状的使用提高了舒适度，且可以使用增加硬度材料，比如半刚性塑料，以提高对变形的抵抗力，从而减小了病人鼻孔的管口变形。而且，由于它和角撑部件的连接，比如，角撑部件是柔软的和屈从的，刚性塑料可以使用以允许薄壁段和管口的柔性。In addition, the use of pre-formed shapes improves comfort, and increased stiffness materials, such as semi-rigid plastics, can be used to increase resistance to deformation, thereby reducing nozzle deformation of the patient's nostrils. Also, due to its connection with the gusset, eg, the gusset is flexible and compliant, a rigid plastic can be used to allow flexibility of the thin walled section and nozzle.
在本示范实施例中，中心导管34的上面部分46可以使用可变形的和可膨胀的材料与角撑部件18和管口或者鼻枕20，22模压为一个整体。中心导管34、鼻枕20，22和角撑部件18可以使用软的、柔性的皮肤相容材料构造，比如，硅树脂。中心导管34、鼻枕20，22和角撑部件18可以用，比如，现有技术已知的的注模法形成。In the exemplary embodiment, the upper portion 46 of the central tube 34 may be integrally molded with the gusset 18 and the nozzles or nasal pillows 20, 22 using a deformable and expandable material. Central tube 34, nasal pillows 20, 22, and gusset 18 may be constructed using a soft, flexible, skin-compatible material, such as silicone. Central tube 34, nasal pillows 20, 22 and gusset 18 may be formed, for example, by injection molding as is known in the art.
然而，中心导管34、鼻枕20，22和角撑部件18可以用任何适合的材料和任何适合的方法来加工。比如，中心导管34、角撑部件18和鼻枕20，22可以被单独加工并使用例如粘合剂、焊接和/或机械紧固件来永久的连接在一起。或者，中心导管34、角撑部件18和鼻枕20，22可以单独加工并可拆卸地相互连接。However, the central tube 34, nasal pillows 20, 22 and gusset 18 may be fabricated from any suitable material and by any suitable method. For example, the central tube 34, the gusset members 18, and the nasal pillows 20, 22 may be separately machined and permanently joined together using, for example, adhesives, welding, and/or mechanical fasteners. Alternatively, the central guide tube 34, gusset member 18 and nasal pillows 20, 22 may be fabricated separately and detachably interconnected.
中心导管34上的下面部分48包括排气孔62和一对构造用来保持头带连接器25到中心管道34上的锥形或者有刺的突起64。排气孔62和上面部分46的开口60对齐。排气孔62从中心导管34向外轻微突起并且包括一系列开口66以清除CO2。The lower portion 48 on the center tube 34 includes a vent hole 62 and a pair of tapered or barbed protrusions 64 configured to retain the headgear connector 25 to the center tube 34 . The vent hole 62 is aligned with the opening 60 of the upper portion 46 . Vent 62 protrudes slightly outward from center duct 34 and includes a series of openings 66 to remove CO2 .
如图89所示，头带连接器25为长带形形态，包括一对适于容纳下面部分48上相对应的突起64的一对开口68和适于承受排气孔62的中心开口70。特别是，开口68押在锥形或者有刺的突起64上以维持和定位头带连接器25到中间导管34上。As shown in FIG. 89 , headgear connector 25 is in the form of an elongated strap including a pair of openings 68 adapted to receive corresponding protrusions 64 on lower portion 48 and a central opening 70 adapted to receive vent hole 62 . In particular, the opening 68 presses over the tapered or barbed protrusion 64 to maintain and position the headgear connector 25 to the intermediate guide tube 34 .
而且，头带连接器25在其自由端具有连接头带组件(没有显示)的连接结构72。头带组件可拆卸地与连接结构72连接以使得鼻组件10在患者脸上保持在期望的位置。例如，头带组件可以包括可拆卸地连接在相应连接结构72上的带。Also, the headgear connector 25 has a connection structure 72 at its free end for connecting a headgear assembly (not shown). The headgear assembly is removably attached to the attachment structure 72 to maintain the nasal assembly 10 in a desired position on the patient's face. For example, the headgear assembly may include straps that are removably attached to corresponding attachment structures 72 .
如图91所示，连接结构72可以具有圆形边缘。而且，开口68，70可以具有任何适合的形状(比如，椭圆形，圆形，矩形等等)。例如，图91显示大致椭圆形开口68，70，图89显示大致圆形开口68和大致正方形的开口70。As shown in FIG. 91, the attachment structure 72 may have rounded edges. Also, openings 68, 70 may have any suitable shape (eg, oval, circular, rectangular, etc.). For example, FIG. 91 shows generally oval openings 68 , 70 , and FIG. 89 shows a generally circular opening 68 and a generally square opening 70 .
头带连接器25用可变形的和弹性的材料来构造，这样它就能在至少一个弯曲面中变形，比如，在使用时围绕着患者的面部。例如，头带连接器25可以用聚丙烯或者任何其他适合的聚合物来构造。此外，头带连接器25可以用天然的或者合成的材料，或者材料的组合比如组合板。头带连接器25是可变形的，这样它就能够在鼻组件10装在病人头上时和病人的脸部轮廓相适配。而且，头带连接器25承担由头带组件施加的力，这样防止张力牵引，以及随后扭曲柔性中心导管16上。The headgear connector 25 is constructed of a deformable and resilient material so that it can deform in at least one curved surface, eg, around the patient's face in use. For example, headgear connector 25 may be constructed of polypropylene or any other suitable polymer. Additionally, the headgear connector 25 may be made of natural or synthetic materials, or combinations of materials such as composite panels. Headgear connector 25 is deformable so that it can conform to the contours of the patient's face when nasal assembly 10 is mounted on the patient's head. Also, the headgear connector 25 bears the forces exerted by the headgear assembly, which prevents tension from pulling, and subsequently twisting, on the flexible central guide tube 16 .
然而，头带连接器25可以有适于连接到头带组件上的任一适合的结构。例如，头带连接器25可以具有在中心导管34上设置的突起64，且头带组件可以直接连接到突起64上。或者，头带连接器可以为构造用来连接头带组件上提供的相应锁夹的锁夹接收器组件的形式。锁夹接收器和锁夹由Moore等人的申请号为60/377,254、60/397,195和60/402,509美国临时申请公开，所有这些在本申请中作为参考。However, the headgear connector 25 may have any suitable configuration for connection to a headgear assembly. For example, the headgear connector 25 may have a protrusion 64 provided on the center tube 34 and the headgear assembly may be directly connected to the protrusion 64 . Alternatively, the headgear connector may be in the form of a clip receiver assembly configured to connect to a corresponding clip provided on the headgear assembly. Clip receivers and clips are disclosed by Moore et al. in US Provisional Application Nos. 60/377,254, 60/397,195 and 60/402,509, all of which are incorporated herein by reference.
中间导管34通过进口连接器40，42连接在该对进气导管36，38上。如图97所示，各进口连接器40，42包括分支成一对第二导管部件76的第一导管部件74。第一导管部件74包括被容纳在中心导管34在其相对末端部分52，54上提供的相应的凹槽56中的径向扩张的边缘78。这样，第一进口连接器40保持在中心导管34的一个末端部分52上，而第二进口连接器42保持在中心导管34的相对末端部分54上。The intermediate conduit 34 is connected to the pair of intake conduits 36 , 38 by inlet connectors 40 , 42 . As shown in FIG. 97 , each inlet connector 40 , 42 includes a first conduit member 74 branching into a pair of second conduit members 76 . The first conduit member 74 includes radially flared edges 78 received in respective grooves 56 provided by the central conduit 34 on opposite end portions 52 , 54 thereof. Thus, the first inlet connector 40 is retained on one end portion 52 of the central conduit 34 and the second inlet connector 42 is retained on the opposite end portion 54 of the central conduit 34 .
进气导管36，38各可以具有连接到相应进气连接器40，42上的第一端和连接到Y形进气连接器44上的第二端。如图96所示，进气导管36，38各具有第一、第二通道80，82。进口连接器40，42的该对第二导管部件76穿过进气导管36，38的第一端的第一和第二通道80，82，以把进气连接器40，42和相应的进气导管36，38的第一端连接在一起。进气连接器40，42和进气导管36，38可以通过摩擦形式配合、机械紧固件、粘合剂、共模压、插入模压或者其他适合的方式保持。Each intake conduit 36 , 38 may have a first end connected to a respective intake connector 40 , 42 and a second end connected to a Y-shaped intake connector 44 . As shown in FIG. 96, the intake ducts 36, 38 each have a first and a second passageway 80,82. The pair of second conduit members 76 of the inlet connectors 40, 42 pass through the first and second passages 80, 82 of the first ends of the inlet conduits 36, 38 to connect the inlet connectors 40, 42 and corresponding inlets. The first ends of the air tubes 36, 38 are connected together. The intake connectors 40, 42 and intake conduits 36, 38 may be retained by friction fit, mechanical fasteners, adhesives, co-molding, insert molding, or other suitable means.
如图96A所示，Y形连接器44包括和进气导管36之一的第二端相连接的第一连接器84，和进气导管38的另一个的第二端相连接的第二连接器86，及连接到气压源以输送加压气体到鼻组件10的第三连接器88。第一和第二连接器84，86各包括穿过进气导管36，38的第一和第二通道80，82以把Y形连接器44和相应进气导管36，38相连接的一对导管部件90。第三连接器88可以包括一个旋转机械装置以允许Y形连接器44和连接在气压源上的输送导管间的相互运动。该Y形连接器44和进气导管36，38可以通过摩擦形式配合、机械紧固件、粘合剂、焊接、插入模压或者任何其他适合的方式保持。As shown in FIG. 96A, the Y-shaped connector 44 includes a first connector 84 connected to the second end of one of the intake conduits 36, and a second connector 84 connected to the other second end of the intake conduit 38. 86, and a third connector 88 connected to a source of air pressure to deliver pressurized gas to the nasal assembly 10. The first and second connectors 84, 86 each include a first and second passage 80, 82 through the intake conduits 36, 38 to connect the Y-connector 44 to a pair of corresponding intake conduits 36, 38. Conduit part 90. The third connector 88 may include a rotating mechanism to allow mutual movement between the Y-connector 44 and the delivery conduit connected to the air pressure source. The Y-connector 44 and intake conduits 36, 38 may be retained by a frictional form fit, mechanical fasteners, adhesives, welding, insert molding, or any other suitable means.
如图98所示，中心导管34和进气导管36，38可以由6,044,844号美国专利所公开的耐压、抗压、或者抗扭曲管道形成。该专利的全文引用在此供参考。As shown in FIG. 98, the center duct 34 and the intake ducts 36, 38 may be formed from pressure-resistant, pressure-resistant, or twist-resistant tubing as disclosed in US Patent No. 6,044,844. The entirety of this patent is incorporated herein by reference.
加压气体通过Y形连接器44的连接器88，接着通过第一和第二进气导管36，38进入中心导管34的两个末端部分。空气通过中心导管34，进入角撑部件18和鼻枕20，22，并进入病人的鼻腔通道12。从病人鼻子排出的气体可以通过中心导管34中设置的排气孔62排出。The pressurized gas enters the two end portions of the central conduit 34 through the connector 88 of the Y-connector 44 and then through the first and second inlet conduits 36 , 38 . Air passes through the central conduit 34, into the gusset 18 and nasal pillows 20, 22, and into the nasal passage 12 of the patient. Air expelled from the patient's nose can be exhausted through a vent hole 62 provided in the central conduit 34 .
如图86和89所示，角撑部件18从中心导管34向外延伸以提提供额外的表面区域和基底区域。当加压后的空气进入中心导管34时，中心导管34和角撑部件18都膨胀，这就移动鼻枕20，22使其与病人的鼻腔通道12密封啮合。然而，中心导管34可以不与角撑部件18一起膨胀。那就是说，角撑部件18被构造为可扩张和收缩以改变中心导管34和鼻枕20，22间的距离。角撑部件18在鼻枕20，22靠近病人鼻腔通道12的第一位置(如图97A所示)和鼻枕20，22移动以与病人鼻腔通道12密封啮合的第二位置(如图97B所示)之间移动鼻枕20，22。特别是，角撑部件18在没有被气体加压时是不膨胀的或者通常是扁平的。然而，在没有膨胀时角撑部件18可以不具有通常的扁平结构。在没有膨胀的情况下，鼻枕20，22与病人的鼻腔通道12是有间隔的或者相互间有轻微的接触。当鼻组件10被气体加压时，角撑部件18被充气和移动鼻枕20，22进入病人的鼻腔通道12密封啮合以在鼻组件10和病人的鼻腔通道12之间形成密封。当气体压力增大时，通过角撑部件18加到鼻腔通道12下方的力就增加了。As shown in Figures 86 and 89, the gusset members 18 extend outwardly from the central tube 34 to provide additional surface area and base area. When pressurized air enters the central tube 34, both the central tube 34 and the gusset 18 expand, which moves the nasal pillows 20, 22 into sealing engagement with the nasal passage 12 of the patient. However, the central conduit 34 may not expand with the gusset 18 . That is, the gusset members 18 are configured to expand and contract to vary the distance between the central guide tube 34 and the nasal pillows 20,22. The gusset members 18 are in a first position in which the pillows 20, 22 are adjacent to the nasal passage 12 of the patient (as shown in FIG. 97A ) and in a second position in which the pillows 20, 22 are moved to sealingly engage the nasal passage 12 of the patient (as shown in FIG. 97B ). move the nasal pillows 20, 22 between. In particular, gusset members 18 are non-expandable or generally flat when not pressurized by gas. However, gusset members 18 may not have a generally flat configuration when not expanded. In the absence of inflation, the nasal pillows 20, 22 are spaced from or slightly in contact with the patient's nasal passage 12. When the nasal assembly 10 is pressurized with gas, the gusset 18 is inflated and moves the nasal pillows 20, 22 into sealing engagement with the patient's nasal passage 12 to form a seal between the nasal assembly 10 and the patient's nasal passage 12. As the gas pressure increases, the force exerted through the gusset 18 under the nasal passage 12 increases.
角撑部件18为中心导管34提供额外的表面区域或基底区域，这随后就为鼻枕20，22提供了额外的压力，也就增加了鼻枕20，22的密封效率。就是说，角撑部件18被配置和定位用来强迫鼻枕20，22和病人的鼻子接触。加在病人鼻子上的力或者压力和中心导管34中的压力以及角撑部件18的额外表面区域是成比例的。这样，角撑部件18的的表面区域可以变化去改变施加在病人鼻子上的力或者压力。The gusset 18 provides additional surface area or floor area for the central tube 34, which in turn provides additional pressure for the nasal pillows 20, 22, thereby increasing the sealing efficiency of the nasal pillows 20, 22. That is, the gusset 18 is configured and positioned to force the nasal pillows 20, 22 into contact with the patient's nose. The force or pressure on the patient's nose is proportional to the pressure in the central conduit 34 and the excess surface area of the gusset 18 . In this way, the surface area of the gusset 18 can be varied to vary the force or pressure exerted on the patient's nose.
角撑部件18减小得到的合适的密封需要的头带组件的张力。就是说，施加在病人鼻子上的压力被角撑部件18提供而不依靠来自头带组件的拉力。这提高了病人的舒适度和密封特性。The gussets 18 reduce the tension of the headgear assembly required to obtain a proper seal. That is, the pressure applied to the patient's nose is provided by the gusset 18 rather than relying on tension from the headgear assembly. This improves patient comfort and sealing characteristics.
因此，理想的是调整头带组件使得鼻枕20，22只是靠近或者非常轻微的与病人鼻子接触。使用这个方法，角撑部件18不被实质压缩。Therefore, it is desirable to adjust the headgear assembly so that the nasal pillows 20, 22 are only in close or very slight contact with the patient's nose. Using this method, the gusset members 18 are not substantially compressed.
角撑部件18可以包括其侧壁26，28之间的连接壁。该连接壁可以象弹簧结构一样以通过鼻枕20，22提供施加在病人脸上的分力。这个力可以通过调整连接壁的厚度来适应地改变。而且，连接壁的厚度可以结合角撑部件18提供的表面区域改变。The gusset member 18 may include a connecting wall between its side walls 26 , 28 . The connecting wall can act like a spring structure to provide component force exerted on the patient's face by the nasal pillows 20,22. This force can be adaptively changed by adjusting the thickness of the connecting wall. Also, the thickness of the connecting walls may vary in conjunction with the surface area provided by the gusset members 18 .
角撑部件18还在中心导管34和鼻枕20，22之间提供去耦连接，这就允许鼻组件10和用户面部之间的一些相对运动。结果，鼻枕20，22可以适应病人鼻特征形状的小变化而没有不适当的力，并且可以在使用中维持有效的密封时解决鼻组件10相对于病人鼻子的小的运动。The gusset 18 also provides a decoupled connection between the central tube 34 and the nasal pillows 20, 22, which allows some relative movement between the nasal assembly 10 and the user's face. As a result, nasal pillows 20, 22 can accommodate small variations in the shape of a patient's nasal features without undue force, and can account for small movements of nasal assembly 10 relative to the patient's nose while maintaining an effective seal in use.
同样，角撑部件18不必是上面所讨论的单一的角撑结构，而是可以为其它的结构。例如，角撑部件18可以是成系列的两个或者多个角撑部件。Likewise, the gusset members 18 need not be of the unitary gusset configuration discussed above, but may be of other configurations. For example, gusset 18 may be a series of two or more gussets.
图98到106示出了以210表示的鼻组件的另一个实施例。如图98到100所示，鼻组件210包括中心导管234，一对连接到中心导管234上的进气导管236，238(比如，通过粘合剂)，相互连接进气导管236，238的进口连接器244。进口连接器244被构造连接到与气压源相连接的导管上。进口连接器244可以为轴向可旋转的以通过减小导管的扭曲增大稳定性。Another embodiment of a nasal assembly indicated at 210 is shown in FIGS. 98 through 106 . As shown in FIGS. 98 through 100, the nasal assembly 210 includes a central conduit 234, a pair of intake conduits 236, 238 connected to the central conduit 234 (e.g., by an adhesive), and interconnecting the inlets of the intake conduits 236, 238. connector 244 . The inlet connector 244 is configured to connect to a conduit connected to a source of air pressure. The inlet connector 244 may be axially rotatable to increase stability by reducing twisting of the conduit.
角撑部件218包括形成他们之间的空间的第一和第二侧壁226，228。第一侧壁226包括和中心导管234上的开口相通的进气开口。第二侧壁228具有一对出气开口。在该示范实施例中，角撑部件18通常为领结状。然而，角撑部件18可以为其他适合的形状。The gusset member 218 includes first and second side walls 226, 228 forming a space therebetween. The first side wall 226 includes an air intake opening that communicates with an opening in the central conduit 234 . The second side wall 228 has a pair of air outlet openings. In the exemplary embodiment, gusset member 18 is generally bow tie-shaped. However, gusset members 18 may be of other suitable shapes.
呈鼻枕形式的一对管口220，222被提供。各鼻枕220，222具有连接到与角撑部件218的各出气开口相通的角撑部件218的第二侧壁228的第一部分230。各鼻枕220，222的第二部分232被构造在使用中和病人鼻子14的鼻腔通道12密封啮合并提供鼻组件210和病人鼻腔通道12之间的密封。A pair of nozzles 220, 222 in the form of nasal pillows are provided. Each nasal pillow 220 , 222 has a first portion 230 connected to the second side wall 228 of the gusset 218 in communication with the respective air outlet opening of the gusset 218 . The second portion 232 of each nasal pillow 220, 222 is configured, in use, to sealingly engage the nasal passage 12 of the patient's nose 14 and provide a seal between the nasal assembly 210 and the nasal passage 12 of the patient.
在该示范实施例中，中心导管234、进气导管236，238、角撑部件218、鼻枕220，222用柔性材料，比如硅树脂来构造，并且使用粘合剂相互连接。然而，中心导管234，进气导管236，238，角撑部件218，鼻枕220，222可以单独模压，或用任意其它适合的原料通过任意适合的方法来形成。In the exemplary embodiment, central conduit 234, intake conduits 236, 238, gusset members 218, and nasal pillows 220, 222 are constructed of a flexible material, such as silicone, and are interconnected using an adhesive. However, the central conduit 234, intake conduits 236, 238, gusset members 218, and nasal pillows 220, 222 may be molded separately, or formed from any other suitable material by any suitable method.
中心导管234包括轻微向外突出的排气孔262(图100和101)以清除CO2。此外，头带连接器225为一对夹子272的形态，连接在导管234，236，238上(比如，通过粘合剂)以连接到头带组件206。头带组件206包括通过挂钩和环状紧固件可移动地连接到相应的夹子272上的带207。如图101和102所示，带207越过病人的耳朵并结合位于病人头部上部的头布208以托住病人的头部枕骨部分。然而，头带组件206可以有其他任意适合的结构以保持鼻组件210在病人头上。Central duct 234 includes slightly outwardly protruding vent holes 262 (Figs. 100 and 101) to removeCO2 . Additionally, the headgear connector 225 is in the form of a pair of clips 272 attached to the conduits 234 , 236 , 238 (eg, by adhesive) for connection to the headgear assembly 206 . The headgear assembly 206 includes a strap 207 removably connected to a corresponding clip 272 by hook and loop fasteners. As shown in Figures 101 and 102, the straps 207 pass over the patient's ears and engage the hood 208 over the patient's head to support the occipital portion of the patient's head. However, headgear assembly 206 may have any other suitable configuration for retaining nasal assembly 210 on the patient's head.
图103至106显示了鼻组件210和病人鼻子14的鼻腔通道12的外边缘相啮合。和上面讨论过的鼻组件10相似，当空气进入中心导管234时，中心导管234和角撑部件218膨胀，这就移动鼻枕220，222进入病人的鼻腔通道23内部密封啮合。然而，中心导管234可以不随着角撑部件218膨胀。就是说，角撑部件218在鼻枕220，222靠近病人的鼻腔通道12的第一位置和鼻枕220，222进入病人的鼻腔通道12密封啮合的第二位置之间移动鼻枕220，222。103 to 106 illustrate the engagement of the nasal assembly 210 with the outer edge of the nasal passage 12 of the patient's nose 14 . Similar to the nasal assembly 10 discussed above, when air enters the central conduit 234, the central conduit 234 and gusset 218 expand, which moves the nasal pillows 220, 222 into sealing engagement within the patient's nasal passage 23. However, the central conduit 234 may not expand with the gusset 218 . That is, the gusset members 218 move the nasal pillows 220, 222 between a first position in which the pillows 220, 222 are proximate to the patient's nasal passage 12 and a second position in which the nasal pillows 220, 222 are in sealing engagement into the patient's nasal passage 12.
在鼻组件10，210的实施例中，进气导管36，38，236，238从鼻枕20，22，220，222向下延伸离开病人的头部。然而，如图107所示，显示为310的鼻组件，可以为一个越过头部的类型组件，在其中进气导管336从鼻枕320，322向上延伸越过病人的头部上方。In the embodiment of the nasal assembly 10, 210, the air intake conduit 36, 38, 236, 238 extends downwardly from the nasal pillows 20, 22, 220, 222 away from the patient's head. However, as shown in FIG. 107, the nasal assembly, shown as 310, may be an over-the-head type assembly in which the air inlet conduit 336 extends from the nasal pillows 320, 322 upwardly over the patient's head.
图107-1示出了一个和图107所示相像的实施例，但是，它包括可调整的前额支架411。前额支架411包括提供给管状支架415的第一部件413。第一部件413和管状支架415之间的连接允许前额支架411的第二部件417相对于病人头部调整以获得尽可能好的配合。第二部件417包括桥419以支撑一个或者多个前额缓冲垫或衬垫421，如同在6,119,693号美国专利和10/655,595号美国专利申请中讨论的那样(每一个在这里引为参考)，和可释放的连接在头带的带425上的头带连接器部件423。头带连接器部件可以为6,374,826号美国专利，其在此引用作为参考，或者60/467,570号美国临时专利申请，其在此引用作为参考中所示的形式。桥419可以包括构造为在空气传送管被引导越过病人头部时适应、引导和/或夹持空气传送管的上部的中间部分。第一部件413可以通过相对于支架415的弯曲，伸缩，和转动来调整。例如，支架415可以包括被引入第一部件413上小孔的枢销429。支架415和第一部件413可以包括多个锁定部件(例如，突起和凹槽)以允许将前额支架411锁在多个(例如3-5，优选是4)预定的位置。FIG. 107-1 shows an embodiment similar to that shown in FIG. 107 , however, it includes an adjustable forehead support 411 . The forehead support 411 includes a first part 413 provided to a tubular support 415 . The connection between the first part 413 and the tubular support 415 allows the second part 417 of the forehead support 411 to be adjusted relative to the patient's head to obtain the best possible fit. The second component 417 includes a bridge 419 to support one or more forehead cushions or pads 421, as discussed in U.S. Patent No. 6,119,693 and U.S. Patent Application No. 10/655,595 (each incorporated herein by reference), and The headgear connector part 423 is releasably attached to the strap 425 of the headgear. The headgear connector component may be of the form shown in US Patent No. 6,374,826, which is incorporated herein by reference, or US Provisional Patent Application No. 60/467,570, which is incorporated herein by reference. Bridge 419 may include an intermediate portion configured to accommodate, guide and/or grip the upper portion of the air delivery tube as it is guided over the patient's head. The first part 413 can be adjusted by bending, telescoping, and rotating relative to the bracket 415 . For example, the bracket 415 may include a pivot pin 429 that is introduced into an aperture in the first member 413 . The support 415 and the first part 413 may include multiple locking features (eg, protrusions and grooves) to allow the forehead support 411 to be locked in multiple (eg, 3-5, preferably 4) predetermined positions.
图107-2示出了类似于在6,532,961号美国专利中揭示的进行操作的可调整前额支架的另一个实施例。该专利在这里引用作为参考。Figure 107-2 shows another embodiment of an adjustable forehead support that operates similarly to that disclosed in US Patent No. 6,532,961. This patent is incorporated herein by reference.
图107A到107C示出了本发明的另外一个可选实施例。图107A是面罩组件650的透视图，而107B是图107A所示面罩组件的一个侧视图。面罩组件650包括头带组件652和鼻缓冲垫组件654。头带组件包括冠带654和枕骨带656。107A to 107C illustrate yet another alternative embodiment of the present invention. Figure 107A is a perspective view of the mask assembly 650, and 107B is a side view of the mask assembly shown in Figure 107A. The mask assembly 650 includes a headgear assembly 652 and a nasal cushion assembly 654 . The headgear assembly includes a crown strap 654 and an occipital strap 656 .
柔性管658包括可以包括旋转连接器的第一端660。柔性管658提供压缩气体的合适的来源。该管包括提供给缓冲垫组件654的第二端662。管658被一个支撑框架664所支撑。支撑框架包括支撑缓冲垫组件654的缓冲垫668的下面部分666。支撑框架还包括一个中间部分670和上面部分672。上面部分672可以包括被间隔分开的柔性臂。柔性臂可以弹性变形以允许柔性管在两个臂之间插入和移出。支撑框架664可以包括在使用中配置靠在病人前额的侧面支撑臂674。各侧面支撑臂674包括为相应的冠带654和枕骨带656分别提供连接点第一和第二连接器槽676，678。The flexible tube 658 includes a first end 660 that may include a swivel connector. Flexible tubing 658 provides a suitable source of compressed gas. The tube includes a second end 662 that is provided to the cushion assembly 654 . Tube 658 is supported by a support frame 664 . The support frame includes a lower portion 666 of a cushion 668 that supports the cushion assembly 654 . The support frame also includes a middle section 670 and an upper section 672 . Upper portion 672 may include flexible arms spaced apart. The flexible arms are elastically deformable to allow insertion and removal of the flexible tube between the two arms. The support frame 664 may include side support arms 674 configured in use to rest against the patient's forehead. Each side support arm 674 includes first and second connector slots 676, 678 that provide connection points for the corresponding crown band 654 and occipital band 656, respectively.
图107B是面罩组件的侧面视图。图107C是在图107A和图107B中所示组件650的放大侧面视图的部分。支撑部件664的下面部分666适于支撑那里所示的缓冲垫668。缓冲垫668包括和充气室682合成整体的一对管口680(示出了一个)。Figure 107B is a side view of the mask assembly. Figure 107C is an enlarged side view portion of the assembly 650 shown in Figures 107A and 107B. The lower portion 666 of the support member 664 is adapted to support a cushion 668 as shown therein. Cushion 668 includes a pair of nozzles 680 (one shown) integral with plenum 682 .
图107D和107E示出了当前发明的另一个实施例。面罩组件690具有包括一个枕骨带694、冠带696、以及各从头带696和枕骨带694之间的连接伸出并且沿着用户面部耳朵向前延伸的下垂臂带698的头带组件692。头带696的上面部分可以包括一个合适的连接器700例如图107A所示的柔性臂。可选择的是，连接器700可以为维可牢尼龙搭扣环形态以帮助固定管702。管702包括具有连接到合适的加压空气源的旋转接头的第一端704。管702被安排在前额的上面并且一般和病人的鼻子有间隔的排成一行。支撑框架708包括一个维持支撑管702在满意位置上的上面部分710。上面部分710可以具有柔性臂，如同像图107A所示的上面部分672。Figures 107D and 107E illustrate another embodiment of the current invention. The mask assembly 690 has a headgear assembly 692 including an occipital strap 694, crown strap 696, and drop arm straps 698 each extending from the connection between the headgear 696 and occipital strap 694 and extending forward along the ears of the user's face. The upper portion of the headband 696 may include a suitable connector 700 such as a flexible arm as shown in FIG. 107A. Optionally, connector 700 may be in the form of a Velcro loop to help secure tube 702 . Tube 702 includes a first end 704 with a swivel joint that connects to a suitable source of pressurized air. Tube 702 is arranged over the forehead and is generally spaced in line with the patient's nose. The support frame 708 includes an upper portion 710 that maintains the support tube 702 in a satisfactory position. Upper portion 710 may have flexible arms, like upper portion 672 as shown in FIG. 107A.
支撑框架708可以具有一对侧臂714，在侧面视图107E中有很好的显示。各侧面支撑臂714都具有适于容纳下垂臂带698的一端的一个连接器槽715。Support frame 708 may have a pair of side arms 714, best shown in side view 107E. Each side support arm 714 has a connector slot 715 adapted to receive one end of the depending arm strap 698 .
图107F示出了面具组件720的一个可选实施例，它具有一个形状一般和字母X相一致的包括一个第一交叉皮带724和第二交叉皮带726的头带组件722。第一交叉皮带724和第二交叉皮带726在一个交叉点或者连接点相汇合。第二交叉皮带726的前端由一个具有维可牢尼龙搭扣环形态的连接器元件730提供。连接器元件730适于支撑或者保持具有连接在相对较大内径管732上面的第一端和适合相对较小内径管734的第二端的一个过度管段。支撑框架736用来维持管734和缓冲垫738在图107所示位置。FIG. 107F shows an alternative embodiment of a mask assembly 720 having a headgear assembly 722 generally shaped to correspond to the letter X including a first cross strap 724 and a second cross strap 726 . The first cross belt 724 and the second cross belt 726 meet at an intersection or connection point. The front end of the second cross strap 726 is provided by a connector element 730 in the form of a Velcro loop. The connector element 730 is adapted to support or hold a transition tube section having a first end connected to a relatively larger inner diameter tube 732 and a second end adapted to a relatively smaller inner diameter tube 734 . Support frame 736 is used to maintain tube 734 and cushion 738 in the position shown in FIG. 107 .
图107G示出了当前发明的另一个实施例的一个面罩组件750，面罩组件750包括一个具有后带754和前额皮带756的头带组件752。悬挂臂皮带758从后带754和前额皮带756的连接点开始延伸。一个或者多个皮带可能具有一个轭状物状物用来帮助加强或者保持该皮带相对其他皮带的位置。如图107G所示，面罩组件750包括一个具有旋转连接器的第一端762，该旋转连接器可以用来连接到空气输送管764，而空气输送管764又提供给一个加压空气源。FIG. 107G shows a mask assembly 750 comprising a headgear assembly 752 having a back strap 754 and a forehead strap 756 in accordance with another embodiment of the present invention. Hanging arm strap 758 extends from the junction of rear strap 754 and forehead strap 756 . One or more of the belts may have a yoke to help strengthen or maintain the belt's position relative to the other belts. As shown in FIG. 107G, the mask assembly 750 includes a first end 762 having a swivel connector for connection to an air delivery tube 764, which in turn provides a source of pressurized air.
如图107H所示，各皮带758包括第一连接器连接部件766，它具有一个或多个可以弹性伸缩以插入和移出连接部件766以在框架768上形成一个适合的凹槽的臂767。框架768具有一个容纳和/连接管760的连接部件770。如图107H所示，只有其中一个管口772上的一部分是可见的。As shown in FIG. 107H , each strap 758 includes a first connector connection member 766 having one or more arms 767 that are elastically retractable for insertion and removal of the connection member 766 to form a suitable groove in the frame 768 . The frame 768 has a connecting member 770 for receiving and/or connecting the tube 760 . As shown in Figure 107H, only a portion of one of the spouts 772 is visible.
图107I示出了本发明的另一个实施例。面罩组件780包括一个具有后带784和前额皮带786的头带组件782。一个管788和连接器790连接而后者又接着和一个或者多个软的柔性的管792连接，而792又和在病人头上两侧的后带784相连接。头带组件782可以包括定位在用户耳朵前面沿着病人面颊的悬挂臂皮带783。每一个管792都适于连接到悬挂臂皮带783上。各管792都适合和一个缓冲垫组件相连。Figure 107I shows another embodiment of the present invention. The mask assembly 780 includes a headgear assembly 782 having a back strap 784 and a forehead strap 786 . A tube 788 is connected to a connector 790 which in turn is connected to one or more soft flexible tubes 792 which in turn are connected to posterior straps 784 on either side of the patient's head. The headgear assembly 782 may include suspension arm straps 783 positioned in front of the user's ears along the patient's cheeks. Each tube 792 is adapted to be connected to a suspension arm strap 783 . Each tube 792 is adapted to be connected to a cushion assembly.
图107I示出的仍然是本发明的另一个实施例。面罩组件800包括只有一部分在图中显示的一个头带组件，头带组件包括一个悬挂皮带802，它支撑连接到缓冲垫组件812上的侧面支撑臂804。各悬挂臂皮带802可以为一个第一端和空气输送管808相连，第二端和连接缓冲垫组件812的管810相连的U形互换装置。Figure 107I shows still another embodiment of the present invention. The mask assembly 800 includes a headgear assembly, only partially shown, including a suspension strap 802 supporting side support arms 804 attached to a cushion assembly 812 . Each suspension arm strap 802 may be a U-shaped interchange with a first end connected to an air delivery tube 808 and a second end connected to a tube 810 connecting to a cushion assembly 812 .
图107K和107L示范仍然是本发明的一个实施例。如图107K所示，一个缓冲垫组件包括一个框架820，一个加压通气室或者风箱室824和一对安装在加压通气室824上的管口826。缓冲垫组件可以被一个或者多个侧面支撑臂822所支撑，如图107K所示。可以选择的是，缓冲垫组件可以被一个如图107A所示的支撑框架所支撑。如图107K所示，管口826具有一个相对低的姿态因为它和病人的鼻腔通道相啮合。然而，如图107L所示，管口826由于它的弹性可以从图107k中所示的较低姿态的位置延伸到图107L中所示的较高姿态的位置。Figures 107K and 107L demonstrate still one embodiment of the present invention. As shown in FIG. 107K , a cushion assembly includes a frame 820 , a plenum chamber or bellows chamber 824 and a pair of nozzles 826 mounted on the plenum chamber 824 . The cushion assembly may be supported by one or more side support arms 822, as shown in Figure 107K. Alternatively, the cushion assembly may be supported by a support frame as shown in Figure 107A. As shown in Figure 107K, the nozzle 826 has a relatively low profile as it engages the patient's nasal passage. However, as shown in Figure 107L, the nozzle 826, due to its resiliency, can extend from the lower profile position shown in Figure 107k to the higher profile position shown in Figure 107L.
图107M至107Q示出了适用于当前方面的各种管口832，834，836，840和844的横截面。如图1070所示，该管口可以包括当管口的中间部分839被鼻腔通道容纳时位于鼻腔通道边缘的壁架838。如图107P所示，管口840包括一个可以避免或者减少在鼻腔通道中间摩擦机会的优点的向外的切口842。如图107Q所示，管口844可能包括一个突起846使得空气通路从鼻腔通道壁倾斜。图107R示出了突起846位置的透视图。Figures 107M to 107Q show cross-sections of various nozzles 832, 834, 836, 840, and 844 suitable for the present aspect. As shown in Figure 1070, the nozzle may include a ledge 838 that sits at the edge of the nasal passage when the medial portion 839 of the nozzle is received by the nasal passage. As shown in Fig. 107P, the nozzle 840 includes an outward cutout 842 which may advantageously avoid or reduce the chance of friction in the middle of the nasal passage. As shown in Figure 107Q, the nozzle 844 may include a protrusion 846 to angle the air passageway from the nasal passage wall. FIG. 107R shows a perspective view of the location of protrusion 846 .
第七示范实施例Seventh exemplary embodiment
图108至113示出了当前发明的另一个实施例。如图108所示，面罩组件660包括头带602和缓冲垫组件604，它们中的每一个相应的和图60，61中示出的头带和缓冲垫组件极大的相似。头带602设计用来抓住患者头部的顶端。通过位于病人头部相反方向的拉环来实现对皮带拉力的调整。滑轮方向和管口组件施加给病人的力不在一条直线上。轭状物为侧面提供稳定性。轭状物至少保持为头带基础形状的一部分以方便头带的插入。头带在面部前方不需要具有可调性。因为对头带组件的所有调节可以从病人头部后方或者上方来的实现。Figures 108 to 113 illustrate another embodiment of the present invention. As shown in FIG. 108, a mask assembly 660 includes a headgear 602 and a cushion assembly 604, each of which is substantially similar to the headgear and cushion assemblies shown in FIGS. 60 and 61, respectively. Headgear 602 is designed to grip the top of the patient's head. Adjustment of the tension of the belt is achieved through the pull ring located opposite the patient's head. The pulley orientation and the force exerted by the nozzle assembly on the patient are not in line. The yoke provides stability to the sides. The yoke remains at least part of the base shape of the headgear to facilitate insertion of the headgear. The headband does not need to be adjustable in front of the face. This is because all adjustments to the headgear assembly can be made from behind or above the patient's head.
在图108的实施例中，缓冲垫组件604的一端具有一个插销622，另一断具有一个旋转肘612。根据用户的偏爱，比如，患者特有的睡觉姿势，旋转肘612和插销622的位置可以互相交换。一个空气输送管606连接在旋转肘612上。空气输送管606可以包括一个旋转接头607和一个同样包括一个旋转接头的端609。端609为加压空气的来源端。In the embodiment of FIG. 108 , the cushion assembly 604 has a latch 622 at one end and a swivel elbow 612 at the other end. The positions of the swivel elbow 612 and latch 622 may be interchanged according to user preferences, eg, the patient's particular sleeping position. An air delivery tube 606 is connected to the swivel elbow 612 . Air delivery tube 606 may include a swivel joint 607 and an end 609 that also includes a swivel joint. Terminal 609 is the source terminal for pressurized air.
如图108所示，肘612从缓冲垫组件604转过大约120度角度。这帮助将管维持在视野范围之外、压力向下减到最小以及保持管的弯曲点尽可能的接近面部。然而，肘可以为一个典型的90度弯曲，比如图109和110所示。As shown in FIG. 108, the elbow 612 is rotated from the cushion assembly 604 through an angle of approximately 120 degrees. This helps keep the tube out of view, minimizes pressure down and keeps the tube's bend point as close to the face as possible. However, the elbow can be in a typical 90 degree bend, such as that shown in FIGS. 109 and 110 .
图109是如108所示的面罩组件600的透视示意图，但是只有头带组件602的轭状物608被显示而没有皮带。如同第五实施例，轭状物608可以具有一个轭状环610。如图109所示，缓冲垫组件可以相对头带旋转调整到一个病人最适合的位置。在图109中，头带上的轭状物608上的环610具有一个定位标记611a，缓冲垫具有许多可以用来选择与定位标记611a排成直线的许多定位标记611b。Figure 109 is a schematic perspective view of the mask assembly 600 as shown at 108, but only the yoke 608 of the headgear assembly 602 is shown without the straps. Like the fifth embodiment, the yoke 608 may have a yoke ring 610 . As shown in Fig. 109, the cushion assembly can be rotated relative to the headgear to adjust to a patient's most suitable position. In Figure 109, the loop 610 on the yoke 608 on the headband has one alignment mark 611a and the cushion has a number of alignment marks 611b that can be selected to line up with the alignment mark 611a.
图110是缓冲垫组件604中一部分的一个横截面视图。特别是，缓冲垫组件604包括一个支撑缓冲垫617的框架616。框架616包括提供给框架616两端和/或缓冲垫617的第一连接器连接部件618。各第一连接器连接部件618具有密封圈614。密封圈和插销都是和第一连接器连接部件618相连的或是设置在第一连接器上的第二连接器的范例。见图110，面罩组件的左手侧具有插销622同时右手侧具有旋转肘612，也可以是图108和109所示的那种颠倒过来的设置。FIG. 110 is a cross-sectional view of a portion of cushion assembly 604 . In particular, cushion assembly 604 includes a frame 616 that supports a cushion 617 . The frame 616 includes first connector connection parts 618 provided to both ends of the frame 616 and/or the cushion pad 617 . Each first connector connection part 618 has a sealing ring 614 . Both the sealing ring and the pin are examples of a second connector that is connected to the first connector connecting member 618 or that is disposed on the first connector. 110, the mask assembly has the latch 622 on the left hand side and the swivel elbow 612 on the right hand side, or the reverse arrangement as shown in FIGS. 108 and 109 is possible.
图110示出的减震器617具有许多设计用来减小噪音的排气孔619。图110-1和110-2示出的是排气孔的两种可能具有的外形的横截面。在图110-2中，端617a通过排气孔的孔将任何可能产生噪音的物质(比如，一个模型缝)排出空气主通道。不同的表述是，模型缝被从一个它可能产生噪音的位置移动到一个产生噪音的可能性较小的位置。Figure 110 shows a shock absorber 617 with a number of vent holes 619 designed to reduce noise. Figures 110-1 and 110-2 show cross-sections of two possible configurations for the vent hole. In Fig. 110-2, end 617a vents any potentially noise-generating material (eg, a mold seam) out of the main air passage through the vent hole. Stated differently, the model seam is moved from a position where it is likely to produce noise to a position where it is less likely to produce noise.
图110A是一个展示密封圈614，第一连接器连接部件618和插销622相互作用的部分横截面示意图。特别是，密封圈614可以由相对应的第一和第二突起624，626提供。为了密封或制动的目的，第一突起624可能和第一连接器连接部件618提供的凹槽618a相互作用。为了密封或制动的目的，第一突起626可能和插销622提供的凹槽628相互作用。如图110A所示，密封圈614包括一个凹槽630以容纳轭状物608上的环610中相应的一个。FIG. 110A is a schematic partial cross-sectional view illustrating the interaction of the seal ring 614 , the first connector connecting member 618 and the pin 622 . In particular, the sealing ring 614 may be provided by corresponding first and second protrusions 624,626. The first protrusion 624 may interact with the groove 618a provided by the first connector connection part 618 for sealing or locking purposes. The first protrusion 626 may interact with a groove 628 provided by the latch 622 for sealing or detent purposes. As shown in FIG. 110A , seal ring 614 includes a groove 630 to accommodate a corresponding one of rings 610 on yoke 608 .
图110B是图110A中面罩组件600右手侧的局部放大视图。旋转肘612的第一端612a插入并容纳在第一连接器连接部件618中。第一端612a包括一个扩大的头部件以防止旋转肘612从组件中不经意的移出。第一端612a至少包括一个开槽613以允许扩大的头部件在插入时通过有弹性的弯曲来减小直径。更合适的是，那里具有很多这样的开槽，比如，四个开槽。密封圈614具有第一和第二突起624，626，如同上面所述。在这种情况下，第二突起626可以通过摩擦力和旋转肘612的外圆周相互总用以提供密封。而且，旋转肘612可以具有凹槽或者其它结构来容纳第二突起626。Figure 110B is an enlarged fragmentary view of the right hand side of the mask assembly 600 in Figure 110A. The first end 612 a of the swivel elbow 612 is inserted into and received in the first connector connection part 618 . First end 612a includes an enlarged head piece to prevent inadvertent removal of swivel elbow 612 from the assembly. The first end 612a includes at least one slot 613 to allow the enlarged head piece to reduce in diameter by resilient bending upon insertion. More suitably, there are many such slots, for example, four slots. The seal ring 614 has first and second protrusions 624, 626, as described above. In this case, the second protrusions 626 may engage each other by friction and the outer circumference of the rotating elbow 612 to provide a seal. Also, the swivel elbow 612 may have a groove or other structure to accommodate the second protrusion 626 .
图110B示意性的演示了旋转肘612和具有一个旋转堵塞631的密封圈614。例如，旋转堵塞631可以为轭状物608的一部分的形态。FIG. 110B schematically illustrates the swivel elbow 612 and the sealing ring 614 with a swivel plug 631 . For example, rotary plug 631 may be in the form of a portion of yoke 608 .
可选则的或者另外，如图111所示，旋转肘612可以具有包括突起634的环633。密封圈614可以被改变成具有旋转堵塞632。与此一致的是，突起634可以沿着旋转肘612转动直到突起634临近靠着旋转堵塞632。因此，空气输送管606的运动可以被限制在提前预定的范围内，比如220度到300度，更好的是250度到270度，这样减小或者避免了空气输送管606和病人之间的不希望的接触。Alternatively or additionally, as shown in FIG. 111 , the swivel elbow 612 may have a ring 633 including a protrusion 634 . The seal ring 614 can be modified to have a rotary plug 632 . Consistent with this, the protrusion 634 can be rotated along the rotation elbow 612 until the protrusion 634 abuts against the rotation block 632 . Therefore, the movement of the air delivery tube 606 can be limited in the range predetermined in advance, such as 220 degrees to 300 degrees, better 250 degrees to 270 degrees, which reduces or avoids the distance between the air delivery tube 606 and the patient. unwanted contact.
图110是框架，第一连接器连接部件618，轭状物608，密封圈614和插销622装配的部分横截面视图。图112表明插销622被插在缓冲垫组件604的右手侧，如图108所示。FIG. 110 is a partial cross-sectional view of the frame, first connector connection member 618 , yoke 608 , seal 614 and pin 622 assembled. FIG. 112 shows that the latch 622 is inserted on the right hand side of the cushion assembly 604 as shown in FIG. 108 .
图113示出了本发明的一个可选实例，在那里插销和密封圈被作为一个整体部件来构造。如图113所示，密封圈636包括一个很好的跟随轭状物608轮廓的边缘部件638。这在图110中的横截面视图中有很好的演示，在其中密封圈614和轭状物608相互紧密毗邻。Figure 113 shows an alternative embodiment of the invention where the pin and seal are constructed as a single unit. As shown in FIG. 113, the seal ring 636 includes an edge member 638 that follows the contour of the yoke 608 very well. This is best demonstrated in the cross-sectional view in Figure 110, where the seal ring 614 and yoke 608 are in close proximity to each other.
第七具体实施例为空气输送管606和旋转肘612提供更好的分离从缓冲组件604。另外，这个实施例提供一个可选的管路线，它可以是缓冲起组件的或上侧或下侧或右手侧或左手侧。这样，这个实施例是较少引人注目和明显较轻的一例。和前面的实施例相比，它具有较少的部件，可以更容易的生产、组装和清洗。The seventh embodiment provides better separation for air delivery tube 606 and swivel elbow 612 from cushioning assembly 604 . Additionally, this embodiment provides an optional line that can be either the upper or lower side or right hand or left hand side of the cushioning assembly. As such, this embodiment is a less dramatic and significantly lighter one. Compared with the previous embodiment, it has fewer parts and can be produced, assembled and cleaned more easily.
旋转肘612具有一个快速释放机械装置(没有示出)。旋转肘612，如图110B所示，能够安装和嵌入面罩框架616。这种结构允许在限制的角度内，在框架616里面自由的旋转，这样确保管不会位于一个对头和鼻枕不舒适的位置。The swivel elbow 612 has a quick release mechanism (not shown). A swivel elbow 612, as shown in FIG. 110B, enables mounting and insertion of a mask frame 616. This configuration allows free rotation within the frame 616 within a limited angle, which ensures that the tubes are not positioned in an uncomfortable position against the head and nasal pillows.
密封圈614被这样构造以便它能和旋转肘612的外形相协调。另外，密封圈614被连接到设置在轭状物608上的环610。例如，图110B中的旋转阻塞631可以构造为环610的一部分，位于框架616两侧的第一连接器连接部件618可以相对密封圈614旋转，从而相应的定位缓冲组件604。密封圈614更好的以最小的摩擦力密封旋转肘612。密封圈614足够长以便病人尤其是手的灵活性减弱的病人掌握The sealing ring 614 is configured so that it can be compatible with the shape of the swivel elbow 612 . Additionally, a sealing ring 614 is connected to a ring 610 provided on the yoke 608 . For example, the rotation block 631 in FIG. 110B can be configured as a part of the ring 610 , and the first connector connecting part 618 on both sides of the frame 616 can rotate relative to the sealing ring 614 , so as to position the buffer assembly 604 accordingly. The seal ring 614 better seals the swivel elbow 612 with minimal friction. The sealing ring 614 is long enough to be grasped by the patient, especially the patient with reduced hand dexterity
插销622可以被压缩以适应进入密封圈614。插销622也可以被设计用来压缩以适应进入框架。插销622可以用硬的聚合物来制造，比如，聚丙烯。凹槽(没有显示)被提供以用来移动插销622。插销在空气输送管的对立面密封框架和面罩组件。插销622足够长以便病人尤其是手的灵活性减弱的病人掌握。Pin 622 may be compressed to fit into seal ring 614 . The latch 622 can also be designed to compress to fit into the frame. Plug 622 can be made of a rigid polymer, such as polypropylene. A groove (not shown) is provided for moving the latch 622 . The latch seals the frame and mask assembly opposite the air delivery tube. The latch 622 is long enough to be grasped by a patient, especially a patient with impaired hand dexterity.
空气输送管606可以被永久连接在在旋转肘612的一端。然而，一个推动摩擦连接也是适合的。空气输送管606可以为200毫米到400毫米长，更适合的是250毫米到300毫米，或者是不干扰病人面部的任何长度。Air delivery tube 606 may be permanently attached at one end at swivel elbow 612 . However, a push friction connection is also suitable. The air delivery tube 606 may be 200 mm to 400 mm long, more suitably 250 mm to 300 mm, or any length that does not interfere with the patient's face.
如图110B和111所示，相应的，轭状物608和密封圈614可以具有限制旋转肘612相对与第一连接器连接部件618的成角度或旋转运动的结构。而且，头带和/或轭状物可以提供空气输送管保持力的作用以控制空气输送管的位置。例如，简单的维可牢尼龙皮带可以用来沿着头带的某些部件去拟制空气输送管的运动。Accordingly, as shown in FIGS. 110B and 111 , the yoke 608 and sealing ring 614 may have structures that limit the angular or rotational movement of the rotational elbow 612 relative to the first connector connection member 618 . Also, the headgear and/or yoke may provide an air delivery tube retention effect to control the position of the air delivery tube. For example, simple Velcro straps can be used to simulate movement of the air delivery tube along certain parts of the headgear.
在图108A和108B所示的另一个例子中，空气输送管护圈900包括被连接或连接到头带的一个皮带上的第一部件902。例如，第一部件902可以为连接到图108所示的头带皮带部件904上的环状形态。In another example shown in FIGS. 108A and 108B, the air delivery tube retainer 900 includes a first member 902 that is attached or attached to a strap of the headgear. For example, the first member 902 may be in the form of a loop attached to the headgear strap member 904 shown in FIG. 108 .
可以通过在将皮带穿过头带扣906之前将皮带穿过第一部件902来实现连接。空气输送管护圈900包括和第一连接部件902相连接的第二连接部件908。第二连接器连接部件908可以用有弹性的塑料来制造并且为图108A所示的形状，具有一个被第二部件908的的两端912所确定的间隙910。间隙690的尺寸比空气输送管606的直径要小以便可靠的容纳空气输送管606。可选则的是，第二连接器连接部件908可以为端912上具有配套的吊钩和环的一个维可牢尼龙环。如图108A和108B所示，第二部件可以具有一个或者多个开槽914以容纳空气输送导管606上的肋916从而阻止空气输送导管606的轴向滑动。使用这种安排，空气输送导管606就可靠的被固定在病人头上的某个位置。The attachment may be accomplished by threading the strap through the first component 902 before threading the strap through the headgear buckle 906 . The air delivery tube retainer 900 includes a second connection member 908 connected to the first connection member 902 . The second connector connecting part 908 may be made of resilient plastic and is shaped as shown in FIG. 108A with a gap 910 defined by two ends 912 of the second part 908 . The gap 690 is sized smaller than the diameter of the air delivery tube 606 in order to securely accommodate the air delivery tube 606 . Optionally, the second connector connection part 908 may be a Velcro loop with a mating hook and loop on the end 912. As shown in FIGS. 108A and 108B , the second component may have one or more slots 914 to accommodate ribs 916 on the air delivery conduit 606 to prevent axial sliding of the air delivery conduit 606 . With this arrangement, the air delivery conduit 606 is securely fixed in place on the patient's head.
图108C为空气输送管护圈900的平面图，其中有相关部分的参考系数。在图108C中，示出了空气输送管护圈900的可仿效的尺寸。要注意的是这些尺寸久久只是举例，标注在那里的尺寸可以变化正负百分之20。Figure 108C is a plan view of the air delivery tube retainer 900 with reference factors for relevant parts. In FIG. 108C , exemplary dimensions for an air delivery tube retainer 900 are shown. Note that these dimensions are examples only and dimensions marked there may vary plus or minus 20 percent.
前后讨论的鼻组件10，210，310，410，510，600有七个优点。例如，鼻组件10，210，310，410，510是不突出的因为它们小的总尺寸和重量。鼻组件10，210，310，410，510，600提供了一个高水平的舒适度因为最小的力施加到病人的鼻子上-并且和病人鼻梁的接触可以排除。鼻组件10，210，310，410，510，600是容易使用的、包括了最少的部分的和容易调整的，比如，进气导管很容易在病人头部上方向上延伸或者在病人下颚下面向下延伸。不需要改变头带设置，气压源就能够很容易的与连接器连接和从连接器拆卸。此外，鼻组件10，210，310，410，510，600允许较大的管口运动范围以适合广大范围的患者。就是说，通过相对头带组件转动框架，管口可以根据病人的面部转动。而且，皮带拉力不需要因为和面部的接触面积少而加大。头带提供稳定性，比如，轭状物帮助保持面罩部件在病人面部的位置。头带的可调整性被设计，这样拉紧皮带需要的力不会施加到病人面部，比如，皮带可以在头部相反的方向拉动以相互平衡。可以相对容易的性能与舒适之间找到平衡。另外，重量、噪音水平和面罩组件的部件数目都减小了。There are seven advantages of the nasal assembly 10, 210, 310, 410, 510, 600 discussed hereafter. For example, nasal assemblies 10, 210, 310, 410, 510 are unobtrusive because of their small overall size and weight. The nasal assembly 10, 210, 310, 410, 510, 600 provides a high level of comfort because minimal force is applied to the patient's nose - and contact with the bridge of the patient's nose is eliminated. The nasal assembly 10, 210, 310, 410, 510, 600 is easy to use, includes a minimum of parts and is easy to adjust, for example, the air inlet duct is easy to extend upwards on the patient's head or to face under the patient's chin. Extend down. The air pressure source can be easily connected to and detached from the connector without changing the headgear setting. Additionally, the nasal assembly 10, 210, 310, 410, 510, 600 allows for a greater range of nozzle motion to accommodate a wide range of patients. That is, by rotating the frame relative to the headgear assembly, the nozzle can be rotated according to the patient's face. Moreover, the tension of the belt does not need to be increased because of the small contact area with the face. The headgear provides stability, eg, the yoke helps maintain the position of the mask components on the patient's face. The adjustability of the headgear is designed so that the forces required to tighten the straps are not applied to the patient's face, eg, the straps can be pulled in opposite directions on the head to balance each other. Finding the balance between performance and comfort can be done with relative ease. In addition, the weight, noise level and part count of the mask assembly are all reduced.
一个包括附图和对本发明首选实施例的各个方面进行描述的目录包括在美国第60/529696号临时申请中，申请日2003年九月十六号，被授权在这里合并。就标注图或者目录中包括的尺寸来说，这些尺寸久久只是举例，可以在不离开所述范围内更改。A bibliography including drawings and descriptions of various aspects of the preferred embodiments of the invention is contained in US Provisional Application No. 60/529,696, filed September 16, 2003, which is incorporated herein by authorization. As far as the dimensions included in the drawing or the catalog are concerned, these dimensions are only examples and can be changed without departing from the stated range.
图114是本发明的另一实施例的分解图。在这个实施例中，缓冲垫组件和图108至109中所示的相似，旋转肘612如同在图108，110B和111中所述一样。轭状物608包括想要和接近或者为凹槽630形态的加宽部件630a相啮合的一个加宽部件608a。另外，轭状物608包括想要容纳密封圈614的耳朵638的一个凹槽608b。此外，轭状物608和头带可以作为一个部件来构成。如同图115中可见的那样，轭状物608和密封圈614可以相对于对方嵌入式安装，例如，通过臂621。通过这个结构，轭状物和密封圈可以避免各自相对于对方的转动。图115还示出了轭状物的弯曲点p的位置，它允许同病人有一个很好的配合。Figure 114 is an exploded view of another embodiment of the present invention. In this embodiment, the cushion assembly is similar to that shown in FIGS. 108-109, and the pivoting elbow 612 is as described in FIGS. 108, 110B and 111. The yoke 608 includes a widening member 608a intended to engage a widening member 630a that approximates or is in the form of the groove 630 . Additionally, the yoke 608 includes a groove 608b intended to receive an ear 638 of the sealing ring 614 . Additionally, the yoke 608 and headgear may be constructed as one piece. As can be seen in FIG. 115 , the yoke 608 and sealing ring 614 may be flush mounted relative to each other, eg, via arms 621 . By this construction, the yoke and the sealing ring are prevented from rotating relative to each other. Figure 115 also shows the position of the flex point p of the yoke, which allows a good fit with the patient.
图116到图126示出了图114和115中所示实施例的详细视图。该排列的另一个方面是轭状物608的环610相对于轭状物608的主体609有角度的偏移。比较图116和图110，举例来说，图116中的主体609是扭曲的。例如，图116中的前侧609a和图116中的后侧609b相比位置侧面向外。这个结构帮助把轭状物608的底部向病人的面部偏移，以便轭状物能够更接近的跟随病人的面部轮廓。116 to 126 show detailed views of the embodiment shown in FIGS. 114 and 115 . Another aspect of this arrangement is the angular offset of the ring 610 of the yoke 608 relative to the main body 609 of the yoke 608 . Comparing Figure 116 and Figure 110, for example, body 609 in Figure 116 is twisted. For example, the front side 609a in FIG. 116 is positioned sideways outward compared to the rear side 609b in FIG. 116 . This configuration helps offset the bottom of the yoke 608 toward the patient's face so that the yoke can more closely follow the contours of the patient's face.
图127到图130示出了当前发明的更进一步的一个实施例。这个实施例和图114到126所示的相类似。然而，有两个主要的不同，第一，轭状物612在密封圈614内能够自由转动360度。如同局部分解视图128所示，和图114所示相比，密封圈614不包括旋转堵塞632，轭状物612不包括突起634。Figures 127 to 130 illustrate a further embodiment of the present invention. This embodiment is similar to that shown in Figures 114 to 126. However, there are two main differences. First, the yoke 612 is free to rotate 360 degrees within the sealing ring 614 . As shown in partially exploded view 128 , seal ring 614 does not include rotational plug 632 and yoke 612 does not include protrusion 634 as compared to that shown in FIG. 114 .
第二，如图129所示，密封圈614包括一个可选择的可拆卸和可插入的封闭盖614。换句话说，图119中的插销622由两部分组成而不是一部分。封闭盖614可以包括排气孔，而不是由缓冲垫提供的排气孔来补充。图130输出了封闭盖614的局部分解视图。因为位于管口组件两个侧面的密封圈614是相同的，如果病人选择肘612的路线在左侧或者右侧。封闭盖614a和肘612可以移动和交换的。此外，考虑到病人的灵活性，肘612可以是可拆卸地。Second, as shown in FIG. 129, the sealing ring 614 includes an optional removable and insertable closure cap 614. In other words, the pin 622 in Fig. 119 is made of two parts rather than one. The closure cap 614 may include vent holes instead of being supplemented by the vent holes provided by the cushion. FIG. 130 shows a partial exploded view of the closure cap 614 . Because the sealing rings 614 on both sides of the nozzle assembly are the same, if the patient chooses the route of the elbow 612 on the left or right. Closure cap 614a and elbow 612 are removable and interchangeable. Additionally, the elbow 612 may be detachable to allow for patient mobility.
图131到133示出了另一个实施例的肘612。和图114中所示的肘612相比，图131到133中的肘612包括一个或者更可能是一对钥匙形状的小孔613。肘可以用聚丙烯来制造，比如，“Borealis”或者聚酯。该小孔的形状允许当肘位于合适的位置和移动时具有提高了的保持力和移动力。131 to 133 illustrate another embodiment of an elbow 612 . In contrast to the elbow 612 shown in FIG. 114 , the elbow 612 in FIGS. 131 to 133 includes one or, more likely, a pair of key-shaped apertures 613 . The elbows can be made of polypropylene, for example, "Borealis" or polyester. The shape of the aperture allows for increased retention and movement when the elbow is in place and moved.
而且，管口组件和与其结合的缓冲垫可以被一个护鼻面罩和护鼻缓冲垫所替代。见图134和135，图134示出了一个具有相对的小孔或者第一连接器连接部件(比如管状延伸)的框架的排列，他们中的每一个都具有如同上面所述的密封圈。密封圈500适于使用一个分散的或者整体的插销去关闭一个孔或者框架的第一连接器，而另一个密封圈适于同其他框架孔/第一连接器相连接以容纳旋转肘。当然，肘和插销的位置可以根据病人的喜爱互相交换。在图135中，肘位于面罩框架的前面，如同ReMed’sVISTA面罩，两个孔/第一连接器连接部件都被密封圈塞紧。当然，在各实施例中，框架，肘，和/或密封圈可以具有适当的排气孔去清除从呼吸室来的气体。Also, the nozzle assembly and its associated cushion can be replaced by a nasal mask and nasal cushion. See Figures 134 and 135, Figure 134 showing an arrangement of frames having opposing apertures or first connector connection members (eg tubular extensions), each of which has a sealing ring as described above. The sealing ring 500 is adapted to use a discrete or integral latch to close a hole or first connector of the frame, while another sealing ring is adapted to connect with the other frame hole/first connector to accommodate the swivel elbow. Of course, the positions of the elbow and latch can be interchanged according to patient preference. In Fig. 135, the elbow is located at the front of the mask frame, as in ReMed's VISTA mask, both hole/first connector connection parts are plugged by the seal ring. Of course, in various embodiments, the frame, elbows, and/or seals may have appropriate vents to remove gases from the breathing chamber.
令人高兴的是，当前这个发明的各方面都已经被完全和有效的完成了。前述的特定实施例是提供用来举例说明当前这个发明的结构和功能原理的，而不是想要限制这个发明。相反的是，当前这个发明包含所有在所详细描述的精神和范围内的修改，改进和置换。Happily, all aspects of the present invention have been fully and effectively accomplished. The foregoing specific embodiments are provided to illustrate the structural and functional principles of the present invention, and are not intended to limit the invention. On the contrary, the present invention embraces all modifications, improvements and permutations within the spirit and scope of the detailed description.
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| US48881003P | 2003-07-22 | 2003-07-22 | |
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| US49411903P | 2003-08-12 | 2003-08-12 | |
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| US52969603P | 2003-12-16 | 2003-12-16 | |
| US60/529,696 | 2003-12-16 | ||
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| Application Number | Title | Priority Date | Filing Date |
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| CN101468222A CN101468222A (en) | 2009-07-01 |
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| CN200910005233.XAExpired - Fee RelatedCN101468222B (en) | 2003-02-21 | 2004-02-20 | Nasal assembly |
| CNB2004800048113AExpired - Fee RelatedCN100479879C (en) | 2003-02-21 | 2004-02-20 | Nose assembly |
| CN200910126046.7AExpired - Fee RelatedCN101496926B (en) | 2003-02-21 | 2004-02-20 | Nasal assembly |
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| CNB2004800048113AExpired - Fee RelatedCN100479879C (en) | 2003-02-21 | 2004-02-20 | Nose assembly |
| CN200910126046.7AExpired - Fee RelatedCN101496926B (en) | 2003-02-21 | 2004-02-20 | Nasal assembly |
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| Publication | Publication Date | Title |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C53 | Correction of patent of invention or patent application | ||
| CB02 | Change of applicant information | Address after:New South Wales, Australia Applicant after:RESMED Ltd. Address before:New South Wales, Australia Applicant before:RESMED Ltd. | |
| COR | Change of bibliographic data | Free format text:CORRECT: APPLICANT; FROM: RAYSMEDD CO., LTD. TO: RESMED LIMITED | |
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CP01 | Change in the name or title of a patent holder | Address after:New South Wales, Australia Patentee after:RESMED Ltd. Address before:New South Wales, Australia Patentee before:RESMED LTD. | |
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee | Granted publication date:20160420 |