Forehead supports for facial masks

The present invention generally relates to the field of forehead support for facial masks used to supply a breathable gas to the wearer's airways.

This application is filed in US Provisional Patent Application No. 60 / 814,056 filed on June 16, 2006, US Provisional Patent Application No. 60 / 836,604 filed on August 10, 2006, and November 14, 2006. Claim the interests of the submitted US Provisional Patent Application No. 60 / 858,694 (each of which is incorporated herein by reference in its entirety).

In addition, PCT Application No. PCT / AU 2006/000037, filed January 12, 2006, is also incorporated herein by reference in its entirety.

Facial masks include continuous positive airway pressure (CPAP) treatment of various respiratory disorders and sleep disorders such as sleep apnea (OSA) and / or non-invasive positive airway pressure (NPPV). Well known for use in other ventilation support procedures such as. For this, see, for example, Patent Document 1 (the entire contents of which are incorporated herein by this citation).

Devices for the treatment of SDB generally include a blower that supplies air to the patient interface via a conduit with positive pressure. The patient interface can take various forms, such as nasal mask assembly and nasal opening mask assembly (ie, full face mask). Patients usually wear a mask assembly during sleep to receive NPPV treatment.

The mask assembly usually comprises a rigid shell or frame and a soft facial contact cushion. This cushion protects the patient's face from the rigid frame and forms a seal with the patient's face. The frame and cushion form a void that accommodates the nose or nose and mouth. The frame and cushion are held in place on the patient's face by the headgear assembly. Headgear assemblies typically include straps that extend along both sides of the patient's face to the back or crown of the patient's head.

One problem with existing masks used in CPAP treatment is that the mask is pressed against the patient's face by tightening the mask strap, which is the wearer's facial features, such as the wearer's nose. Excessive force will be applied to the. Incompletely attached masks leak when pressurized, which causes the patient to overtighten the headgear straps, which in turn causes discomfort and damage to the face and, in some cases, swelling of the face. Is attached.

Therefore, conventional masks have forehead support, which provides a support and stabilization mechanism between the mask and the forehead. Forehead support prevents the mask from being pressed excessively against the wearer's facial area and minimizes mask movement by increasing contact points between the mask and the wearer's head. Suppress, thereby reducing unpleasant pressure points. In addition, it has a gusset facial cushion as disclosed in Simultaneously Pending US Provisional Patent Application No. 60 / 643,113, filed January 12, 2005, the entire contents of which are expressly incorporated herein by this reference. Forehead supports can be employed to control the amount of opening and / or closing of the gusset with respect to the facial mask, thereby assisting the force exerted on the wearer's face, eg, the patient's nasal area.

Generally, the forehead support of the mask is adjustable, which makes the standard mask adjustable to suit a large number of patients with different anthropometric features. Conventional masks with adjustable forehead support are apparent from Patent Documents 2-5, and the entire contents of each such patent document are clearly incorporated herein by reference. To enhance the adjustment function, the conventional forehead support can also change the relative angle between the mask and the forehead support to accommodate the facial features of a particular wearer. To provide the means, they are displaceable with respect to the mask, for example, as shown in Patent Document 6 (whose entire content is expressly incorporated herein by this reference).

<p><patcit num="1"><text>U.S. Pat. No. 4,944,310</text></patcit><patcit num="2"><text>U.S. Pat. No. 6,119,693</text></patcit><patcit num="3"><text>U.S. Pat. No. 6,463,931</text></patcit><patcit num="4"><text>U.S. Pat. No. 6,557,556</text></patcit><patcit num="5"><text>U.S. Pat. No. 6,691,708</text></patcit><patcit num="6"><text>U.S. Pat. No. 6,532,961</text></patcit></p>

<p> However, the problem with traditional forehead support for masks is that the range of adjustment is relatively limited, and therefore it does not provide a universal fit for a significant number of wearers. is there. That is, due to the anthropometric features of a particular user's head, the adjustment function of the conventional forehead support is not sufficient to achieve a comfortable fit. Therefore, while the forehead support mentioned above works fine, improvements to the forehead support for masks have been sought.</p>

<p> In certain embodiments, the mask forehead support provides better wearing universality than a conventional forehead support structure. More specifically, embodiments of the present invention provide forehead support with a more useful and informative adjustment range as compared to conventional forehead support structures, thereby prior to the present invention. Forehead support can be more universally adapted to a very large number of patients.</p><p> One aspect of the invention is a frame connector provided for the mask frame and a forehead portion operably disposed with respect to the frame connector for substantially linear movement between retracted and protruding positions with respect to the frame connector. An adjustment knob that is movably arranged on the cushion support and the frame connector and is screwed into the forehead cushion support. The rotation of this adjustment knob causes the forehead cushion support to protrude into the retracted position. It has an adjustment knob that can be moved to and from the position. The adjustment knob relates to a forehead support for a mask assembly comprising an elastic prong with ratchet bumps. The ratchet bump is configured to selectively engage a series of ridges provided on the frame connector for indexed incremental adjustment.</p><p> Another aspect of the invention is a frame connector provided to the mask and a forehead portion operably disposed with respect to the frame connector for substantially linear movement between retracted and protruding positions with respect to the frame connector. It relates to a forehead support for a mask assembly comprising a cushion support and an adjustment knob operably disposed with respect to a frame connector. The knob features a threaded shaft that is threaded into a female threaded tube provided for the forehead cushion support, and the rotational movement of the adjustment knob causes the forehead cushion support to move between retracted and protruding positions. It is designed to be made to. The frame connector has a notch that allows the upper portion of the tube to be recognized.</p><p> Another aspect of the invention relates to a forehead support for a mask assembly. The forehead support is a frame connector provided to the mask frame and a forehead cushion operably arranged with respect to the frame connector for substantially linear movement between the retracted and protruding positions with respect to the frame connector. It comprises a support and an adjustment knob operably disposed with respect to the frame connector. The adjustment knob features a threaded shaft that is threaded into a female threaded tube provided for the forehead cushion support, and the rotational movement of the adjustment knob provides forehead cushion support between retracted and protruding positions. It is designed to work. Position markings are given to the frame connector and / or adjustment knob to indicate the position of the forehead cushion support.</p><p> The present invention will be described in the context of a full facial mask, but those skilled in the art will appreciate that such description represents one preferred embodiment and is therefore non-limiting. I want to be understood. Therefore, the structural and / or functional features of the present invention can also be effectively employed in, for example, nasal masks or nasal prongs, nozzles, nostril seals, and / or cannulas.</p><p> Other aspects, features and advantages of the present invention will become apparent from the following detailed description, along with accompanying drawings that are part of the present disclosure and exemplify the principles of the present invention.</p><p> The accompanying drawings facilitate the understanding of various embodiments of the present invention.</p>

<figref num="1-1">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-2">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-3">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-4">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-5">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-6">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-7">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-8">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-9">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="1-10">FIG. 6 is an external view of a full facial mask assembly including a forehead support according to an embodiment of the present invention.</figref><figref num="2-1">It is the external view of the frame of the mask assembly shown in FIGS. 1-1 to 1-10.</figref><figref num="2-2">It is the external view of the frame of the mask assembly shown in FIGS. 1-1 to 1-10.</figref><figref num="2-3">It is the external view of the frame of the mask assembly shown in FIGS. 1-1 to 1-10.</figref><figref num="2-4">It is the external view of the frame of the mask assembly shown in FIGS. 1-1 to 1-10.</figref><figref num="2-5">It is the external view of the frame of the mask assembly shown in FIGS. 1-1 to 1-10.</figref><figref num="2-6">It is the external view of the frame of the mask assembly shown in FIGS. 1-1 to 1-10.</figref><figref num="2-7">It is the external view of the frame of the mask assembly shown in FIGS. 1-1 to 1-10.</figref><figref num="3-1">It is the external view of the frame connector of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="3-2">It is the external view of the frame connector of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="3-3">It is the external view of the frame connector of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="3-4">It is the external view of the frame connector of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="3-5">It is the external view of the frame connector of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="3-6">It is the external view of the frame connector of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="4-1">It is the external view of the adjustment knob of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="4-2">It is the external view of the adjustment knob of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="4-3">It is the external view of the adjustment knob of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="4-4">It is the external view of the adjustment knob of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="4-5">It is the external view of the adjustment knob of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="4-6">It is the external view of the adjustment knob of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="4-7">It is the external view of the adjustment knob of the forehead support shown in Fig. 1-1 to Fig. 1-10.</figref><figref num="5-1">It is an external view of the forehead cushion support of the forehead support shown in FIGS. 1-1 to 1-10.</figref><figref num="5-2">It is an external view of the forehead cushion support of the forehead support shown in FIGS. 1-1 to 1-10.</figref><figref num="5-3">It is an external view of the forehead cushion support of the forehead support shown in FIGS. 1-1 to 1-10.</figref><figref num="5-4">It is an external view of the forehead cushion support of the forehead support shown in FIGS. 1-1 to 1-10.</figref><figref num="5-5">It is an external view of the forehead cushion support of the forehead support shown in FIGS. 1-1 to 1-10.</figref><figref num="5-6">It is an external view of the forehead cushion support of the forehead support shown in FIGS. 1-1 to 1-10.</figref><figref num="5-7">It is an external view of the forehead cushion support of the forehead support shown in FIGS. 1-1 to 1-10.</figref><figref num="6-1">It is external drawing of the frame connector based on another embodiment of this invention.</figref><figref num="6-2">It is external drawing of the frame connector based on another embodiment of this invention.</figref><figref num="6-3">It is external drawing of the frame connector based on another embodiment of this invention.</figref><figref num="6-4">It is external drawing of the frame connector based on another embodiment of this invention.</figref><figref num="6-5">It is external drawing of the frame connector based on another embodiment of this invention.</figref><figref num="6-6">It is external drawing of the frame connector based on another embodiment of this invention.</figref><figref num="6-7">It is external drawing of the frame connector based on another embodiment of this invention.</figref><figref num="7-1">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="7-2">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="7-3">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="7-4">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="7-5">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="7-6">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="7-7">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="7-8">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="8-1">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="8-2">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="8-3">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="8-4">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="8-5">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="8-6">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="8-7">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="9-1">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="9-2">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="9-3">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="9-4">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="9-5">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="9-6">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="9-7">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="9-8">It is an external view of the assembly of the frame connector, the adjustment knob and the forehead cushion support shown in FIGS. 6-1 to 6-7, 7-1 to 7-8 and 8-1 to 8-7.</figref><figref num="10-1">It is a figure which shows the position marking on the forehead cushion support based on one Embodiment of this invention.</figref><figref num="10-2">It is a figure which shows the position marking on the forehead cushion support based on one Embodiment of this invention.</figref><figref num="10-3">It is a figure which shows the position marking on the forehead cushion support based on one Embodiment of this invention.</figref><figref num="10-4">It is a figure which shows the position marking on the forehead cushion support based on one Embodiment of this invention.</figref><figref num="10-5">It is a figure which shows the position marking on the forehead cushion support based on one Embodiment of this invention.</figref><figref num="11-1">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-2">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-3">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-4">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-5">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-6">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-7">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-8">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-9">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-10">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-11">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-12">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-13">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-14">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="11-15">It is a figure which shows the position marking provided for the frame connector and / or the adjustment knob based on the embodiment of this invention.</figref><figref num="12-1">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="12-2">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="12-3">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="12-4">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="12-5">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="12-6">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="12-7">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="12-8">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="13">FIG. 6 is a schematic view of an elastic prong for an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-1">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-2">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-3">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-4">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-5">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-6">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-7">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="14-8">FIG. 3 is an external view of an adjustment knob based on another embodiment of the present invention.</figref><figref num="15-1">It is an external view of the frame based on another embodiment of this invention.</figref><figref num="15-2">It is an external view of the frame based on another embodiment of this invention.</figref><figref num="15-3">It is an external view of the frame based on another embodiment of this invention.</figref><figref num="15-4">It is an external view of the frame based on another embodiment of this invention.</figref><figref num="16-1">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="16-2">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="16-3">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="16-4">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="16-5">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="16-6">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="16-7">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="17-1">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="17-2">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="17-3">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="17-4">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="17-5">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="17-6">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="17-7">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="18-1">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="18-2">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="18-3">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="18-4">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="18-5">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="18-6">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="18-7">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="19-1">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="19-2">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="19-3">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="19-4">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="19-5">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="19-6">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref><figref num="19-7">It is an external view of the forehead cushion support based on another embodiment of this invention.</figref>

The following is a description of some of the illustrated and illustrated embodiments of the invention, which share common qualities and features. It should be understood that one or more features of one embodiment may be combined with one or more features of another embodiment. Moreover, each single feature or combination thereof in any of the embodiments may constitute a further embodiment.

Each of the embodiments illustrated and described includes features that can be used with the embodiments and / or components disclosed in PCT application number PCT / AU2006 / 000030, as will be apparent to those skilled in the art. PCT / AU 2006/000037 is incorporated herein by reference in its entirety.

1. First embodiment of forehead support FIGS. 1-1 to 1-10 show a full facial mask assembly (FMA) 10 including a forehead support 12 according to an embodiment of the present invention. As shown, the mask assembly 10 includes a frame 14 (see FIGS. 2-1 to 2-7) and a cushion 16 provided to the frame 14 and configured to form a seal with the patient's face. Support between the mask assembly 10 and the patient's forehead and an elbow assembly 18 provided to the frame 14 and configured to be connected to an air supply tube that supplies the patient with breathable gas. -Equipped with a forehead support 12 (see Figures 2-1 to 5-7) to provide a stabilizing mechanism. The headgear assembly (not shown) can be detachably attached to the frame 14 and forehead support 12 to maintain the mask assembly 10 in the desired adjusted position on the patient's face. ..

Further details and embodiments of the mask assembly and forehead support are disclosed in PCT Application No. PCT / AU 2006/000037 (which is incorporated herein by reference in its entirety). The forehead support 12 is described as being embodied as the type of mask assembly described above, but it can be embodied as another mask system, such as a full face mask, mouth mask, or nasal mask.

In this embodiment, the forehead support 12 uses a screw actuator to move the forehead support 12 along a substantially straight path. The main components of the forehead support 12 are the frame connector 20 (also called the support or receiver) provided for the mask frame 14 (see Figures 2-1 to 3-6) and the threaded shaft 42 (Figure 4). Forehead cushion support 60 (also known as T-bar) with adjustment knob 40 (also known as dial), including -1 to Figure 4-7) and tube 62 with female threads (see Figure 5-1 to Figure 5-7). Is called). The forehead cushion support 60 supports a forehead cushion 90 configured to engage the patient's forehead during use (see Figures 1-1 to 1-10). Further details and embodiments of the forehead cushion are disclosed in PCT Application No. PCT / AU 2006/000037 (which is incorporated herein by reference in its entirety).

In one embodiment, the component first inserts the female threaded tube 62 of the forehead cushion support 60 into the frame connector 20, and then assembles the adjustment knob 40 to the frame connector 20 and the forehead cushion support 60. Can be assembled by. However, other assembly procedures, such as the knob first, and then the forehead cushion support, such as the structure shown in Figures 16-1 to 19-7, can be assembled. Further details of the assembly will be described below.

When the adjustment knob 40 is rotated, the female threaded tube 62 of the forehead cushion support 60 protrudes or retracts from the threaded shaft 42 of the adjustment knob 40, which causes the adjustment movement of the forehead cushion 90. ..

In one embodiment, the component rotates the adjustment knob 40 until it disengages from the female threaded tube 62 of the forehead cushion support 60, and then pulls the adjustment knob 40 off the frame connector 20 to remove it. It can be disassembled by (for example, separating by snap method). That is, the knob 40 is over-rotated, i.e., excessively torqued at the end of the movement along the tube 62 in order to disengage it from the tube 62 and the frame connector 20. Subsequently, the forehead cushion support 60 is pulled out from the frame connector 20.

1.1 Forehead cushion support As shown in FIGS. 5-1 to 5-7, the forehead cushion support 60 includes a female threaded tube 62 coupled to a forehead cushion support plate 64 that supports the forehead cushion 90. .. As best shown in FIGS. 5-2 and 5-7, the support plate 64 is provided with vertical reinforcing ribs 66 to provide good bending strength. Also, as best shown in Figure 5-6, the support plate 64 makes an angle with respect to the tube 62, for example about 15-25 °, preferably 21 ° from the vertical line.

The tube 62 has two fissures 68 that divide the tube 62 into two elastic arms 70 that can be flexed to allow insertion of the tube 62 into the frame connector 20. In the illustrated embodiment, the crevice 68 extends to the cushion support plate 64. However, in an alternative embodiment, the fissures 68 may end at any point along the tube 62 so that they allow sufficient deflection of the tube 62 into the frame connector 20.

The female threaded tube 62 is a keyway or length provided on the frame connector 20 that receives each protrusion 22 (eg, three protrusions) (see FIGS. 3-2, 3-3 and 3-5). It has a large slot 72 (for example, three keyways). This structure prevents the tube 62, and thus the forehead cushion support 60, from twisting, or rotating, with respect to the frame connector 20. The use of an odd number of keyways 722 also prevents erroneous assembly of the forehead cushion support 60 to the frame connector 20.

As shown, ridges or holding bumps 74 are provided at the ends of each keyway 72. The ridge 74 bends the arm 70 when assembled to the frame connector 20 and prevents the frame connector 20 from being unintentionally separated from the forehead cushion support 60. In the illustrated embodiment, a lead-in 75 is provided in front of each ridge 74 to aid alignment during assembly (eg, the ridge 74 is inside the tube 62 by, for example, 5 mm). To be separated from).

In the illustrated embodiment, the forehead cushion support plate 64 includes a slot 76 for attaching a headgear strap. The headgear strap may include Velcro® for length adjustment. A gap 78 is provided in each support plate 64 to allow the headgear straps to be attached without removing the Velcro® and without compromising the correct headgear length. This structure facilitates the assembly and separation of the headgear strap to the forehead cushion support plate 64.

In certain embodiments, the width of the slot 76 for the headgear strap is preferably 6 mm, and is 8 mm or less. This width constrains the headgear straps to prevent excessive movement of the straps relative to slot 76.

It should be noted that the forehead cushion support plate 64 may include other suitable structures for engaging with the headgear straps, such as a clip receiving structure for engaging with the headgear clips.

The forehead cushion support 60 has a relatively large thickness in a region, for example, the wide upper wall 80 as shown in FIG. 5-3, in order to impart bending and twisting strength to the forehead cushion support plate 64. And may have width.

1.2 Adjustment knob As shown in FIGS. 4-1 to 4-7, the adjustment knob 40 includes a threaded shaft 42. In the illustrated embodiment, the threaded shaft 42 and the adjustment knob 42 are integrally formed (eg, integrally molded) as one-piece components. However, the adjustment knob 40 and the threaded shaft 42 may be configured as two parts and may be combined permanently or semi-permanently, for example with an adhesive. In the illustrated embodiment, the threaded shaft 42 comprises a two-start design.

The knob 40 has two semi-elliptical finger grips 44 that make the operation of the knob 40 easier. The knob 40 also has two outer ridges 46 that are radially opposed to each other. These ridges 46 can be used as a visual and muscular sensory means for aligning the knobs 40 so that an accurate forehead support position is achieved. For example, the Ridge 46 can be used to point to the start / finish position, which provides tactile feedback. In the illustrated embodiment, the two-start screw of the threaded shaft 42 is aligned with the two ridges 46 so that when the knob 40 is fully tightened, the two ridges 46 extend approximately vertically.

In an alternative embodiment, a single ridge can be used to point to the position of knob 40. Since the knob 40 can be assembled in two directions 180 degrees out of phase by the two-start threaded shaft 42, the ridge may start at the top or bottom.

The adjustment knob 40 snaps into place with respect to the frame connector 20. In particular, the knob 40 comprises a segment 48 that is inserted into the frame connector 20. An annular rim 50 is provided on the segment 48, which can engage the retaining function 24 provided on the frame connector 20 (see FIGS. 3-1 and 3-3). The segment 48 comprises two crevices 49 that divide the segment 48 into two elastic arms 52, in which the elastic arm 52 snaps into and out of the rim 50, and thus the knob 40, with the holding function portion 24. It can be flexed to allow it to be engaged. It should be noted that the annular rim 50 is thicker near the crevice 49, which provides a uniform force for snapping on and off the knob 40, regardless of the orientation of the knob. The grip 44 and / or ridge 46 also facilitates assembly and separation of the knob 40 with respect to the frame connector 20.

The threaded shaft 42 is configured to engage within the female threaded tube 62 of the forehead cushion support 60 such that the threaded shaft 42 meshes with the female threaded tube 62. When the knob 40 is rotated, the female threaded tube 62 protrudes or retracts from the threaded shaft 42, which causes the forehead cushion 90 to adjust.

The elastic prong 54 with the ratchet bump 56 is located in each of the two crevices 49 of the adjustment knob 40. When the knob 40 is assembled to the frame connector 20, the ratchet bump 56 engages a series of ridges 26 (see FIGS. 3-1 and 3-3) that surround the inner surface of the frame connector 20. Bump / ridge engagement provides tactile feedback in use, as described below.

As best shown in Figure 4-7, the ratchet bump 56 is at an angle of α, for example 5-6 degrees, with respect to the vertical axis. The bump 56 is beveled so that an equal load acts on the surface of the bump 56 when the prong 54 and its bump 56 bend during assembly to the frame connector 20. This results in more uniform wear on the surface of the bump 56.

As best shown in Figures 4-3 and 4-4, each prong 54 also helps reduce stress on the prong 54 and prevent damage to the prong 54 from the knob 40. Therefore, it has an hourglass or "neck" shape. This waist allows the bending force to be more evenly distributed along the length of the prong 54 rather than being concentrated at the proximal end of the prong 54.

Further, the knob 40 includes a plurality of horns 58, for example four horns, around the upper outer surface of the segment 48. The four horns 58 facilitate centering of the knob 40 within the frame connector 20. More specifically, the horn 58 rests on an annular surface 28 (see FIGS. 3-1 and 3-3) within the frame connector 20 that acts as a smooth support surface.

In one embodiment, the adjustment knob 40 is composed of a clear polyamide 12, eg, clear nylon 12, which is a different material (eg, polycarbonate) than the rest of the forehead support. This structure reduces the noise that would occur if two polycarbonate parts were used, such as squeaking. Further, the transparent microcrystalline polyamide 12 has the advantage of being transparent.

1.3 Frame connector As described above and most shown in FIGS. 3-1 to 3-6, the frame connector 20 engages the holding mechanism 24 for attaching the knob 40 with the bump 56 provided on the prong 54 of the knob 40. It comprises a series of ridges 26, an annular surface 28 that engages the horn 58 of the knob 40, and three protrusions 22 for guiding the tube 62 of the forehead cushion support 60.

In the illustrated embodiment, the ridge 26 comprises twelve crests and troughs that engage bumps 56 provided on the prongs 54 of the knob 40. When the knob 40 is rotated, the bump 56 intermittently or clicks against the ridge 26 to provide an indexed (indexed) incremental adjustment of the forehead support and of the forehead support. Provides tactile feedback on position. In addition, the bump 56 helps keep the forehead support in position, for example to prevent self-winding. That is, the bumps 56 will fit within each ridge 26 to help constrain the forehead cushion in the desired position. In one embodiment, each click corresponds to a movement of 1 mm, resulting in a total movement of 24 mm (ie, two revolutions).

As best shown in Figures 1-3, 1-4, 1-9, 2-6 and 3-6, the frame connector 20 has a notch 30 at the rear, which allows it. The upper part of the tube 62 becomes recognizable. This structure allows marking or position labels to be added to the tube 62 to indicate the position of the forehead cushion support 60. The position marking will be described in detail below.

2. Second embodiment of forehead support Figures 6-1 to 9-8 show the forehead support 212 based on other embodiments of the present invention. The forehead support 212 includes a frame connector 220 provided to the mask frame 14 (see FIGS. 6-1 to 6-7) and an adjustment knob 240 with a threaded shaft 242 (FIGS. 7-1 to 7). -8) and a forehead cushion support 260 (see Figures 8-1 to 8-7) with a female threaded tube 262. The assembly (see FIGS. 9-1 to 9-8) and function of the forehead support 212 is substantially the same as the forehead support 12 described above.

2.1 Forehead cushion support As shown in FIGS. 8-1 to 8-7, the forehead cushion support 260 is a female threaded tube 263 coupled to the forehead cushion support plate 264 that supports the forehead cushion (eg, Figure 8--). (See screw 263 of 1). As best shown in FIGS. 8-2 and 8-4, the support plate 264 is provided with horizontal reinforcing ribs 266 to achieve good bending strength. Further, as best shown in Figure 8-5, the support plate 264 makes an angle with respect to the tube 262, for example about 15-25 °, or preferably 21 °, from the vertical line.

The tube 262 includes two crevices 268 that divide the tube 262 into two elastic arms 270 that can be flexed to allow insertion of the tube 262 into the frame connector 220. In the illustrated embodiment, the crevice 268 extends to the cushion support plate 264.

The female threaded tube 262 is a keyway or long slot 272 (eg, three protrusions) provided on the frame connector 220 (see Figures 6-2 to 6-7) that receives each protrusion 222 (eg, three protrusions). For example, it has three keyways). Three holes 265 are provided in the support plate 264 at the end of the keyway 272. The three holes 265 allow the three protrusions 222 of the frame connector 220 to protrude through the support plate 264 when the forehead cushion support 260 is retracted (eg, FIGS. 9-2, 9). -3 and Figure 9-5). This structure provides longer and more stable mounting.

As shown, ridges or holding bumps 274 are provided at the ends of each keyway 272. The ridge 274 flexes the arm 270 when assembled to the frame connector 220 and prevents accidental separation of the forehead cushion support 260 from the frame connector 220. In the illustrated embodiment, the ridge 74 is provided at the end of the tube 262 (ie, there is no introduction as in the forehead cushion support 60).

In the illustrated embodiment, the forehead cushion support plate 264 comprises a slot 276 for attaching a headgear strap. The headgear strap may have Velcro® for length adjustment. A gap 278 is provided in each support plate 264 to allow the headgear straps to be attached without compromising the correct headgear length by removing Velcro®. Such a structure facilitates the assembly and separation of the headgear straps on the forehead cushion support plate 264.

In the illustrated embodiment, the width of slot 276 is greater than the width of the forehead cushion support 60. However, other suitable widths are possible. Further, the forehead cushion support 260 may be thinner in some areas when compared to the forehead cushion support 60, for example, the upper wall 280 of the forehead cushion support 260 may be the forehead cushion support 60. It is thinner than that of (see Fig. 8-6).

2.2 Adjustment knob With reference to FIGS. 7-1 to 7-8, the adjustment knob 240 is substantially the same as the adjustment knob 40 described above. In contrast, each prong 254 does not have an hourglass or "neck" shape like that of prong 54 (see Figures 7-5 and 7-6).

As mentioned above, the ratchet bump 256 of each prong 254 forms an angle of α, for example 5-6 degrees, with respect to the vertical axis. Such a structure is shown more clearly in Figure 7-4.

2.3 Frame connector As shown in FIGS. 6-1 to 6-7, similarly to the frame connector 20 described above, the frame connector 220 has a holding mechanism portion 224 for attaching the knob 240 and a bump 256 provided on the prong 254 of the knob 240. It comprises a series of ridges 226 that engage with, an annular surface 228 that engages the horn 258 of the knob 240, and three protrusions 222 for guiding the tube 262 of the forehead cushion support 260.

As shown, the three protrusions 222 project from the frame connector 220, which provides a stable connection with the forehead cushion support 260. This configuration contrasts with that of the frame connector 20, which has a protrusion inside the frame connector 20.

3. Position marking on forehead support In certain embodiments, position markings can be provided on the tube, frame connector, and / or adjustment knob of the forehead cushion support to indicate the position of the forehead support.

3.1 Position marking on the tube Indicators (eg artwork or symbols) may be added to the tube to point to the 24 positions of the adjustment knob (for example, each click on the knob corresponds to a movement of 1mm, for a total movement of 24mm. Therefore, the number of clicks or positions is 24). Artwork can be achieved by pad printing (after molding). Other options for applying artwork on the tube are etching, laser etching, and in-mold decoration (in this case, the artwork is pre-printed, punched, and molded on polycarbonate. (Placed in the mold prior to).

Figure 10-1 shows a forehead cushion support 360 with a tube 362 with local in-mold decoration 395. As shown, the in-mold decoration 395 has a separation marking to indicate the position of the forehead support when the tube 362 is projected and retracted during use. This marking may extend along the overall length of the tube 362 to achieve high resolution.

Figures 10-2 to 10-4 show forehead cushion supports 460,560,660 including tubes 462,562,662 with different embodiments of pad printing artwork 495,595,695. As shown, the artwork 495,595,695 features separate markings (which are numbered) to indicate the position of the forehead support when the tube is projected and retracted during use. In the illustrated embodiment, 24 markings or steps are provided, which are numbered for each of the three positions. This artwork provides a series of steps that the user can easily understand. The forehead cushion supports 460,560,660 are all shown in the "24" or fully protruding position. The current position is aligned with the bottom of each notch 430,530,630 of the frame connector.

However, other suitable markings (eg, simple lines or alphabetic labels) may be added on the tube.

Figure 10-5 shows typical dimensions of the forehead cushion support 460 with artwork 495. In one example, A could be 5.75 to 6.25 mm, for example 6.0 mm, B could be 6.6 to 7.6 mm, for example 7.1 mm, and C could be 26.2 to 28.2 mm, for example 27.2 mm. Well, and D can be 23.95 to 23.45 mm, for example 24.2 mm. Although specific dimensions and ranges have been shown, it should be understood that these dimensions and ranges are merely examples and may be other dimensions and ranges depending on the application. For example, a range +/- 10% different from what is presented would be suitable for a particular application.

3.2 Position marking on frame connector and / or adjustment knob Position markings can be added to the frame connector and / or adjustment knob to indicate the position of the forehead support.

3.2.1 First Embodiment Figure 11-1 shows an embodiment of the forehead support 712, in which the frame connector 720 has a simple line 784 at its top and the adjustment knob 740 is around its outer surface. Equipped with ascending bump 786. In use, one of the rising bumps 786 can be aligned with line 784 on the frame connector 720 to point to the position of the forehead support.

In one embodiment, the bump 786 on the knob 740 can be formed during molding of the knob 740 within the molding tool, and the simple line 784 is in a suitable color (eg blue), eg by pad printing. Can be printed on the frame connector 720. With such a structure, position marking that is relatively easy to embody is realized.

The ascending or height-varying bump 786 on the knob 740 provides a grip for rotation, along with tactile feedback of the knob's position. In addition, the alignment of the pad print line 784 at the top of the frame connector 720 (as shown in Figure 11-1) with the large bumps on the knob 740 allows the knob 740 to be assembled and calibrated accurately.

In certain embodiments, the forehead cushion support 760 may include two zone markings indicating whether one is in the first or second rotation of the knob 740. For example, as shown in Figure 11-2, tube 762 of the forehead cushion support 760 has a first zone Z1 with a first color (eg white) and a second color different from the first color. A label defining a second zone with (eg, blue) may be provided on its top edge. Each color indicates the full rotation of the knob 740 (eg 360 °) in use. That is, the color of the tube indicates whether the knob is within its first rotation range or within its second rotation range.

3.2.2 Second embodiment FIG. 11-3 shows an embodiment of the forehead support 812, in which the frame connector 820 includes a print line 884 with a textured incremental marking 885 around its outer surface. The adjustment knob 840 comprises a single print line 886. In use, the line 886 on the knob 840 can be aligned with a selected one of the line 884 or marking 885 on the frame connector 820 to indicate the position of the forehead support.

In certain embodiments, lines 884,886 on the frame connector 820 and knob 840 can be printed on it in the appropriate color, eg blue, for example by pad printing. Textured incremental markings 885 can be formed, for example, during molding of the frame connector 820. Such a method provides position marking that can be embodied relatively easily.

By aligning the relatively long pad print line 886 on the knob 840 (as shown in Figure 11-3) with the relatively long pad print line 884 on the top edge of the frame connector 820. The knob 840 can be assembled and adjusted accurately. In addition, it is clear that the two pad print lines 884,886 (eg the blue line) are aligned for accurate assembly and calibration.

In certain embodiments, the forehead cushion support 860 may have two zone markings (such as those shown in Figure 11-2), which means that the knob 840 has a first rotation or a second rotation. Indicates that it is in a rotating state.

The forehead support 812 realizes a structure in which the set value can be specified relatively easily. For example, when the patient rotates the knob 840 from a fully open position, the patient may be instructed by a "white-2" that will correspond to position P.

3.2.3 Third Embodiment 11-4 and 11-5 show an embodiment of the forehead support 912, in which the frame connector 920 and the adjustment knob 940 have an asymmetrical shape. As shown, the frame connector 920 and knob 940 have an elongated upper end. In this structure, it is relatively easy to align, assemble and calibrate the adjustment start point, for example by adjusting the knob 940 until its outer surface is flush with the outer surface of the frame connector 920. it can. In addition, this asymmetrical shape provides good tactile feedback on the knob position.

3.2.4 Fourth Embodiment Figures 11-6 to 11-10 show an embodiment of the forehead support 1012, in which the frame connector 1020 has a transparent window 1084 (eg, a fisheye window or a gloss window) at its top. And, the adjustment knob 1040 has a numerical and / or graphic scale 1086 (see FIGS. 11-7 to 11-10) recognizable through the window 1084 around its outer surface. When in use, the selected numeric and / or graphical position on the scale 1086 on the knob 1040 can be aligned with the window 1084 on the frame connector 1020 to indicate the position of the forehead support.

In some embodiments, the outer surface of the frame connector 1020 surrounding the window 1084 can also be given a grainy texture. Further, the knob 1040 may be provided with a ridge or rib 1041 to provide a grip for rotation as well as tactile feedback of the knob position.

In certain embodiments, the numerical and / or graphic scale 1086 on the knob 1040 can be printed on it in a suitable color, eg, by pad printing.

In addition, the forehead cushion support 1060 may have two-zone markings (as shown in Figure 11-2), which means that the knob 1040 is in the first or second rotation state. Point to that. This structure is highly normative and allows for precise adjustment, due to the presence of zones pointed to by the numerical and / or graphic positions within the forehead cushion support 1060 and window 1084. Is.

Figures 11-7 to 11-10 show alternative embodiments of the window 1084 on the frame connector 1020 and / or the scale 1086 on the knob 1040. In each embodiment, the scale 1086 is provided on a portion of the knob 10040 surrounded by the frame connector 1020 to allow the patient to read the scale 1086 through the window 1084.

In Figure 11-7, the scale 1086 includes a numerical and ascending height band to indicate the position of the forehead support. In Figure 11-8, the window 1084 is located on the frame connector 1020, inside (as opposed to Figure 11-7), for example near the holding rim of the knob, and the scale 1086 contains only numbers. I'm out. In Figure 11-9, scale 1086 contains only numbers to indicate the position of the forehead support. In Figure 11-10, the scale 1086 contains only the ascending height band to indicate the position of the forehead support. However, other suitable scales and window forms can also be adopted.

3.2.5 Fifth Embodiment Figure 11-11 shows an embodiment of the forehead support 1112, in which the frame connector 1120 has an incremental recess 1184 around its outer surface, and the adjustment knob 1140 is a frame connector. It comprises a clicker 1186 configured to selectively engage the recesses provided on the 1120. In use, the clicker 1186 on the knob 1140 can selectively engage one of the recesses 1184 on the frame connector 1120 to point to the position of the forehead support.

As shown, knob 1140 includes ridges or ribs 1141 to provide tactile feedback of knob position as well as grip for rotation.

Clicker 1186 and ridge 1141 provide good location information that is both visual and tactile. In addition, the clicker 1186 and ridge 1141 provide a structure that allows relatively easy alignment, assembly and calibration of adjustment start points.

In addition, the forehead cushion support 1160 may include a two-zone marking (as shown in Figure 11-2), which is either in the first rotation state or in the second rotation state. Indicates if it is in. This makes it possible to relatively easily define the clicker set value along with the set value, for example, the zone on the forehead cushion support.

3.2.6 6th Embodiment Figures 11-12 to 11-13 show one embodiment of the forehead support 1212, in which the frame connector 1220 comprises a print line 1284 with a texture marking 1285 etched around its outer surface. ing. The adjustment knob 1240 comprises a ridge or rib 1241. In use, the ridge 1241 on the knob 1240 can be aligned with a selected one of the line 1284 or marking 1285 on the frame connector 1220 to point to the position of the forehead support.

In certain embodiments, line 1284 on the frame connector 1220 can be printed on it in a suitable color, eg blue, by pad printing, eg.

The ridge 1241 on the knob 1240 provides tactile feedback on the position of the knob as well as a grip for rotation. In addition, the ridge 1214 and the relatively long pad print line 1284 at the top of the frame connector 1220 provide a structure that allows relatively easy alignment, assembly and calibration of adjustment start points.

In certain embodiments, the forehead cushion support 1260 may include a two-zone marking (as shown in FIG. 11-2) indicating that it is in a first or second rotation state.

The forehead support 1212 implements a structure that allows the knob setting to be relatively easily defined along with the set value, eg, the zone on the forehead cushion support.

3.2.7 7th Embodiment Figure 11-14 shows an embodiment of the forehead support 1312, in which the frame connector 1320 has a marking 1384 at its top and the forehead cushion support 1360 is the frame connector 1320. It has a depth gauge at its top, or position indicator 1386, with a single marking 1387 that can move against the marking 1384 above. As shown, the position indicator 1386 extends over the top edge of the frame connector 1320, and the marking 1387 is provided at the free end of the position indicator 1386. In use, when the knob 1340 is rotated, the position indicator 1386 moves with respect to the frame connector 1320, and the marking 1387 on the position indicator 1386 is on the frame connector 1320 to point to the position of the forehead support. Can be aligned with a selected one of the 1384 markings.

In addition, the knob 1340 includes a ridge or rib 1341, which aligns with a selected one of the markings 1385 provided around the outer surface of the frame connector 1320 to indicate the position of the forehead support. be able to. The ridge 1341 provides tactile feedback on the position of the knob, as well as a grip for rotation. In addition, the marking 12385 helps ensure that the knob 1340 is in the correct ratchet position and is not in between.

The ridge 1341 and position indicator 1386 provide a structure that allows relatively easy alignment, assembly and calibration of adjustment start points. In addition, with position indicator 1386, the forehead cushion support 1360 does not require two-zone marking (as shown in Figure 11-2).

3.2.8 8th Embodiment FIG. 11-15 shows an embodiment of the forehead support 1412, in which the frame connector 1320 is provided with a marking 1484 at its upper end and the forehead cushion support 1460 is a frame connector 1420. Includes a depth gauge or position indicator 1486 at its top, with a single marking 1487 that can move relative to the marking 1484 above. As shown, the position indicator 1486 has a shroud-like shape that surrounds, or covers, the upper end of the frame connector 1420, and the marking 1487 is provided at the free end of the position indicator 1486. In use, when the knob 1440 is rotated, the position indicator 1486 moves with respect to the frame connector 1420, and the marking 1487 on the position indicator 1486 is on the frame connector 1420 to point to the position of the forehead support. Can be aligned with a selected one of the 1484 markings.

In addition, the knob 1440 includes a ridge or rib 1441 that provides a grip for rotation as well as tactile feedback on the position of the knob.

The position indicator 1486 is sturdy and helps reduce and / or eliminate "play" between the forehead cushion support 1460 and the frame connector 1420. In addition, the position indicator 1486 keeps the forehead cushion support 1460 from becoming slender, and makes it more integrated with the mask frame, for example, especially in fully protruding positions.

In certain embodiments, the markings 1484,1487 and position indicator 1486 on the frame connector 1420 can be printed on them in the appropriate colors, for example by pad printing.

The ridge 1441 and position indicator 1486 provide a structure that allows relatively easy alignment, assembly and calibration of adjustment start points. In addition, with the position indicator 1486, the forehead cushion support 1460 does not require two-zone marking (as shown in Figure 11-2).

4. Alternative embodiment of the adjustment knob 12-1 to 12-8 show adjustment knobs 1540 based on other embodiments of the present invention. The adjustment knob 1540 is similar to the adjustment knobs 40,240 described above. However, each prong or ratchet 1554 does not have a hinged or cantilevered form like that of the prongs 54,254 described above.

In particular, each ratchet 1554 has a non-cantilever form, in which each end of the ratchet 1554 is supported by a segment 1548. The ratchet extends in the direction of rotation of the knob 1540, for example the ratchet 1554 is moved 90 ° with respect to the prong 254. Therefore, the profile of ratchet bump 1556 extends substantially parallel to the mask frame at maximum deflection, for example when the bump flexes over the ridge tip of the frame connector. This structure ensures that the load is distributed over the ratchet bumps 1556 rather than concentrating the load on the supporting ends of the cantilever structure.

In one embodiment, the ratchet bumps 1556 of each ratchet 1554 have an angle of α with respect to the vertical axis, for example about 1 degree. Such a configuration is shown more clearly in Figure 12-7.

In an alternative embodiment, as shown in FIG. 13, the knob may include hinged or cantilevered prongs 1654, in which each prong 1654 (in an hourglass shape such as that of prong 54). Has a trapezoidal shape. With such a structure, the Prong 1654 is provided with a relatively wide base at its proximal end to reduce stress. Ratchet bump 1656 is provided distal to the prong 1654, i.e. at the free end. The remaining elements of the knob may be substantially similar to the knob 40 described above.

5. Alternative embodiment of adjustment knob and frame connector 14-1 to 15-4 show a frame 1714 that includes an adjustment knob 1740 and a frame connector 1720 for forehead support according to another embodiment of the invention. The adjustment knob 1740 and frame connector 1720 can be used with forehead cushion supports, such as those shown in Figures 5-1 to 5-7.

As shown in FIGS. 14-1 to 14-8, the adjustment knob 1740 is similar to the adjustment knob 40 described above. However, the wall thickness of segment 1748, which forms the elastic arm 1752 inserted into the frame connector 1720, has been increased to, for example, about 1.85 mm. The arm 1752 provides the force required to adjust the knob 1740 and the force required to disconnect the knob 1740 from the frame connector 1720 to substantially prevent it from flexing excessively easily. It has a larger thickness to distinguish it.

The annular rim 1750 provided in segment 1748 also engages with the holding mechanism 1724 provided in the frame connector 1720 by snap fitting. Since the segment 1748 has a larger thickness, an annular recess is provided in which the holding mechanism portion 1724 is present.

Further, as best shown in FIGS. 14-5 and 14-6, each opening 1755 between the arms 1752, where each elastic prong 1754 is placed, has a substantially triangular shape. In the adjustment knob 40 described above, this opening has a substantially T-shape. Knob 1740 functions like Knob 40. However, the triangle with an opening of 1755 would be advantageous for ratcheting force against the frame 1714 when in use.

As shown in FIGS. 15-1 to 15-4, the frame 1714 and its frame connector 1720 are similar to the frame 14 and frame connector 20 described above. However, the number of holding mechanism parts 1724 of the frame connector 1720 has been increased to four holding mechanism parts 1724 (rather than the two holding mechanism parts 24 of the frame connector 20). Retaining mechanisms 1724 are preferably evenly spaced around the frame connector 1720 to prevent twisting of the adjustment knob 1740 during assembly and disassembly.

6. Alternative embodiment of forehead cushion support 16-1 to 19-7 show four alternative embodiments of the forehead cushion support shown in FIGS. 8-1 to 8-7 described above. Each embodiment has a different flexing structure to allow insertion of the tube into the frame connector.

6.1 First Alternative Embodiment Figures 16-1 to 16-7 show the forehead cushion support 1860 based on other embodiments of the present invention. The forehead cushion support 1860 is similar to the forehead cushion support 260 described above with respect to FIGS. 8-1 to 8-7. However, the tube 1862 includes a keyway or elongated slot 1872 (eg, three keyways) with a bionette-like morphology to allow the tube 1862 to be inserted into the frame connector.

In particular, an L-shaped or bionet-shaped slot 1877 is provided as a lead-in to each keyway 1872. During assembly, the forehead cushion support 1860 needs to be twisted to guide a protrusion on the frame connector that passes through each L-shaped slot 1877 and into each keyway 1872.

In addition, at least one of the keyways 1872 comprises a bendable retaining member 1874 adjacent to the L-shaped slot 1877 to prevent unintentional separation of the forehead cushion support 1860 from the frame connector. As shown, slots 1879 are provided on both sides of the holding member 1874, which allows the holding member 1874 to flex during assembly of the tube 1862 to the frame connector.

6.2 Second alternative embodiment Figures 17-1 to 17-7 show the forehead cushion support 1960 based on other embodiments of the present invention. The forehead cushion support 1860 is similar to the forehead cushion support 260 described above with respect to FIGS. 8-1 to 8-7. However, the tube 1962 is provided with a keyway or elongated slot 1972 (eg, three keyways) with a bionette-like morphology to allow the tube 1962 to be inserted into the frame connector.

In particular, an L-shaped or bionet-shaped slot 1977 is provided as an introduction to each keyway 1972. Upon assembly, the forehead cushion support 1960 needs to be twisted to guide the protrusion on the frame connector through each L-shaped slot 1977 and into each keyway 1972.

In addition, at least one of the keyways 1972 has a bendable holding arm 1974 (eg, cantilevered) within the L-shaped slot 1977 to prevent unintentional separation of the forehead cushion support 1960 from the frame connector. Arm) is provided. As shown, the holding arm 1974 can flex toward the center of the tube 1962 when assembling the tube 1962 to the frame connector.

6.3 Third Alternative Embodiment 18-1 to 18-7 show the forehead cushion support 2060 based on other embodiments of the present invention. The forehead cushion support 2060 is similar to the forehead cushion support 260 described above with respect to FIGS. 8-1 to 8-7. However, the tube 2062 has two vertical fissures 2068 (rather than the horizontal fissure 268 of the tube 262), which can be flexed to allow the tube 2062 to be inserted into the frame connector. Dividing the tube 2062 into two elastic arms 2070. The crevice 2068 can have a suitable length along the tube 2062.

In addition, the tube 2062 comprises a keyway or elongated slot 2072 (eg, three keyways) with a bionette-shaped form to allow insertion of the tube 2062 into the frame connector. In particular, the L-shaped or bionet-shaped slot 2077 is provided as an introduction to each keyway 2072. During assembly, the forehead cushion support 2060 must be twisted to guide the protrusion on the frame connector through each L-shaped slot 2077 and into each keyway 2072.

Ridges or holding bumps 2074 are provided at the ends of each L-shaped slot 2077. The Ridge 2074 bends the arm 2070 when assembled to the frame connector to prevent unintentional separation of the forehead cushion support 2060 from the frame connector.

6.4 Fourth Alternative Embodiment 19-1 to 19-7 show the forehead cushion support 2160 based on other embodiments of the present invention. The forehead cushion support 2160 is similar to the forehead cushion support 260 described above with respect to FIGS. 8-1 to 8-7. However, the tube 2162 includes a keyway with a bionette-shaped form, i.e. a long slot 2172 (eg, three keyways) to allow the tube 2162 to be inserted into the frame connector.

In particular, an L-shaped or bionet-shaped slot 2177 is provided as an introduction to each keyway 2172. During assembly, the forehead cushion support 2160 must be twisted to guide a protrusion on the frame connector that passes through each L-shaped slot 2177 and into each keyway 2172.

In addition, at least one of the keyways 2172 includes a bendable holding arm 2174 within the L-shaped slot 2177 to prevent unintentional separation of the forehead cushion support 2160 from the frame connector. As shown, slots 2179 are provided on each side of the holding arm 2174, which allows the holding member 2174 to flex when the tube 2162 is assembled to the frame connector.

7. Curved forehead cushion support In an alternative embodiment, the tube of the forehead cushion support may be slightly curved so that the forehead cushion support moves along a curved or arched path.

Although the present invention has been described in the context of what is currently considered to be the most practical and preferred embodiment, the invention is not limited to the disclosed embodiments, and on the contrary, the gist of the invention and It should be understood that it is intended to cover the various variants and equivalent structures contained within the scope. Further, the various embodiments described above can be embodied in combination with other embodiments, for example, an embodiment of one embodiment may be combined with an embodiment of another embodiment in order to realize yet another embodiment. Can be done. In addition, each independent feature or component of a given assembly may constitute a further embodiment. Further, the present invention has specific uses for patients suffering from OSA, but patients suffering from other diseases (eg, congestive heart failure, diabetes, morbid obesity, seizures, barriatric surgery, etc.) benefit from the above disclosure. Please understand that you can get. Moreover, the disclosures herein are equally applicable to patients and non-patients.

10 Full facial mask assembly 12 Forehead support 14 frames 16 Cushion 18 Elbow assembly 20 frame connector 22 Overhang 24 Retention function 26 Ridge 28 Coronal plane 30 notch 40 Adjustment knob 42 threaded shaft 44 Semi-elliptical finger grip 46 Ridge 48 segments 49 crevice 50 annular rim 52 Elastic arm 54 Elastic prong 56 Ratchet Bump 58 horn 60 Forehead cushion support 62 Tube with female thread 64 Forehead cushion support plate 66 Vertical reinforcement ribs 68 crevice 70 elastic arm 72 keyway 74 Ridge 75 Introduction 76 slots 78 Gap 80 top wall 90 Forehead cushion