Nasal seal and respiratory interface

Abstract

To provide a nasal seal for a respiratory interface and / or an interface including the nasal seal.SOLUTION: A nasal seal for a respiratory interface comprises a supple lower-nose-receiving center part having a concave shape pre-formed to receive and sealingly contact the tip, lower sides, and base of the nose and sealingly contact the upper lip, and position an aperture for gas flow beneath the nares of a wearer. The seal may have resilience or memory towards this preformed shape.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention generally relates to a nasal seal for a respiratory interface and to an interface including the nasal seal, which includes either a mask or both a mask and a headgear.

Background Art

[0002] A respiratory interface is used to provide one or more respiratory gases, such as air in CPAP therapy, to a user under positive pressure. The nasal interface delivers gas to the nose.

[0003] The seal of an indirect nasal interface contacts the upper lip, the face on both sides of the nose, and the nasal bridge, substantially surrounding the nose. The indirect nasal interface may have a relatively large portion on the face, may apply pressure to the nasal bridge, and the frame of the interface may include a T-shaped component that connects to a headgear on the wearer's forehead, generally interfering with, for example, the wearing of glasses.

[0004] A direct nasal interface is generally less obtrusive because it generally has a small portion on the face and does not include a T-shaped component. However, a direct nasal interface generally includes nasal pillows or the like and enters the wearer's nostrils to ensure an effective seal.

Summary of the Invention

Problems to be Solved by the Invention

[0005] It is an object of the present invention to provide a nasal seal and / or an interface that is improved in at least one aspect or that provides at least a useful option for the general public or medical professionals.

Means for Solving the Problems

[0006] Broadly, in one aspect, the present invention includes a nose seal for a mask interface or a mask interface including a nose seal, the seal including a side surface that contacts the face, i.e., the wearer side surface, the wearer side surface receiving and sealingly contacting the tip of the nose, the lower sides of the nose, and the base of the nose and sealingly contacting the upper lip, and having a flexible lower nose receiving central portion pre-formed to position an aperture for gas flow below the nostrils of the wearer, the flexible central portion including left and right side wall portions that contact the left and right lower sides of the wearer's nose on the left and right sides of the aperture, at least the upper sections of the left and right side wall portions having a shape that protrudes outward, i.e., a convex shape (away from the inside of the seal), on the opposite side of the seal, and the seal including an outward-facing side surface of the seal that faces the wearer side surface, the outward-facing side surface of the seal including left and right stabilizing outer portions that terminate at left and right outer tips and are adapted to contact the face adjacent to the lower flanks of the nasal wings on the left and right sides of the nose during wear, the left and right outer portions of the seal being less flexible or stiffer compared to at least the central portion of the wearer side surface of the seal.

[0007] The left and right side wall portions of the flexible central portion of the seal extend away from each other from the aperture. In at least some embodiments, the outwardly protruding, i.e., convex, shape of the left and right side wall portions or the upper sections of the left and right side wall portions is arranged to seal against wrinkles or depressions at the junction between the bottom of both sides of the nose and the face. These outwardly protruding, i.e., convex, upper sections on the opposite side of the seal are generally above the aperture in the height direction of the seal.

[0008] In at least some embodiments, the outward-facing side surface of the seal connects to the upper peripheral portion, the lower peripheral portion, and the outer tip peripheral portion of the wearer side surface of the seal, and the wall thickness becomes thinner from the outside of the seal to the wearer side surface of the seal. In at least some embodiments, the left and right peripheral portions of the seal at the left and right outer tips that contact the face during wear include a substantially linear portion that bridges the upper peripheral portion and the lower peripheral portion of the seal.

[0009] Generally, the lower edge of the aperture is spaced rearward from the upper edge of the aperture in the depth direction of the seal.

[0010] In at least some embodiments, the seal includes a hollow interior filled with air under positive pressure during use, at least inside the flexible lower nose receiving concave central portion on the wearer side of the seal.

[0011] Generally, the flexible lower nose receiving concave central portion has elasticity or memory to return to the pre-formed shape.

[0012] In at least some embodiments, the central portion includes an upper wall portion that contacts the wearer's nose tip above the aperture, and a lower wall portion that contacts the upper lip under the wearer's nose below and rearward of the upper wall portion.

[0013] In at least some embodiments, the upper wall portion, the lower wall portion, and the left and right side wall portions may have a complex curved shape (and to the extent of having approximate principal planes that are not in the same plane respectively).

[0014] The flexible upper wall, lower wall, and side wall portions at the center of the wearer side of the seal have a shape pre-formed to receive and make a sealing contact with the wearer's nasal tip, the underside of the nose, and the underside of the nose so as to conform to them. The flexible central portion on the wearer side of the seal may have this pre-formed shape even when not under positive air pressure from within the seal. Because it is flexible, it flexibly conforms, but in at least a preferred embodiment, it also has elasticity or a memory to return to this pre-formed shape. In other words, the seal has a "structure" for maintaining this pre-formed shape. Therefore, even before the internal gas flow through the seal creates a positive pressure within the seal, for many wearers, the seal naturally conforms to or matches the shape of these parts of the wearer's nose with only relatively minor shape changes or deformations. The pressure of the internal gas flow within the seal presses the seal against these parts of the wearer's nose. For other wearers, the pressure of the internal gas flow within the seal also causes the seal to change its shape more significantly so as to match the shape of the wearer's nose.

[0015] The seal does not make a seal against the nasal bridge. The seal preferably does not extend at least to a significant extent, such as more than about 1 cm, across any flat portion of the cartilage of the nasal ridge between the nasal tip and the nasal bridge.

[0016] In at least some embodiments, the upper wall portion of the flexible central portion on the wearer side of the seal specifically includes an upper concave section (within the larger overall concave surface of the flexible central portion on the wearer side of the seal) that receives the nasal tip, and this section is concave in both the height and width of the seal. The thickness of the middle wall of this upper concave section is thicker than the remaining part of the central portion on the wearer side of the seal, but may be thinner than the left and right outer stabilizing portions on the wearer side of the seal or thinner than the outer-facing side of the seal. It may extend from the upper edge of the outlet aperture of the seal to or towards the upper periphery of the seal.

[0017] In at least some embodiments, the wearer side surface of the seal also includes left and right outer stabilization portions outside the left and right side wall portions of the flexible central portion, contacts the wearer's face adjacent to the lower lateral side of the small nose on the left and right sides of the nose, and these outer stabilization portions are flexible or soft, but have a relatively lower flexibility (or are relatively harder) than the more flexible lower nose receiving central portion of the wearer side surface of the seal. For example, these left and right outer stabilization portions may have a wall section that is thicker than the wall section of the lower nose receiving central portion.

[0018] The seal can be adjusted such that the joint or change in wall thickness on both sides of the seal between the inner edges of these left and right outer stabilization portions and the flexible central portion of the seal is placed at or adjacent to the joint between the lower side surface of the nose and the face adjacent to the nose.

[0019] The left and right outer portions of the outer-facing side surface of the seal may be relatively less flexible than both the lower nose receiving central portion and the left and right outer stabilization portions of the wearer side surface of the seal. For example, the wall thickness of the left and right outer portions on the outside of the seal can be made thicker than both the central portion and the left and right stabilization portions of the wearer side surface of the seal. The hollow interior of the seal can extend between the left and right outer or side portions of the outer-facing side surface and the wearer side surface of the seal.

[0020] An interface that the seal may partially include includes a frame to which the seal can be attached. In at least some embodiments, the seal and the frame together form an enclosure having a gas inlet opening to the respiratory system and an aperture to the wearer through the seal.

[0021] In a preferred embodiment, the frame includes side arms that extend outwardly (away from each other) and rearwardly beyond the left and right tips of the seal, and extend upwardly at a shallow angle and along the left and right cheeks and particularly the cheekbones of the wearer to connect to the headgear and hold the seal against the wearer's face. Such side arms are longer than they are deep or thick, and may be elastically and flexibly connected to the central portion of the frame and / or be elastically flexible along their length, and may extend to a location between the wearer's ear and eye and / or up to the wearer's temple, where the side arms are connected to the headgear. The shape of the frame side arms and / or the angle between the frame side arms is such that the side arms rest on the left and right cheeks and particularly the cheekbones of the wearer to assist in stabilizing the interface against rotation about the horizontal axis during wear.

[0022] The side arms include at their outer ends a connector portion for removably connecting the frame to the headgear. In a preferred form, the end of each frame side arm includes a hook, particularly an upwardly opening hook portion, for insertion into a loop of the headgear.

[0023] In a preferred embodiment, the interface does not include a T-shaped component that extends upward from the frame (during wear) for connection to the headgear at the wearer's forehead.

[0024] In one embodiment, a headgear suitable for use with the interface assembly of the present invention includes a rear strap that extends around the back of the wearer's head and a top strap that extends over the top of the wearer's head. The rear strap may extend around the lower rear of the wearer's head, particularly over the lower occipital bone. The top strap may be a crown strap or a forehead strap.

[0025] The seal of the present invention includes relatively inflexible left and right stabilizing outer portions adapted to contact the face adjacent to the lower lateral side of the alae nasi on the left and right sides of the nose during attachment. The seal has enhanced stability against rotation on the face, for example, due to the pulling force of a tube. This rotation can break the seal and cause leakage. This is the case even if the seal does not seal against the delicate nasal bridge or does not extend at least significantly, such as more than about 1 cm, across any flat portion of the cartilage of the nasal sill between the nasal bridge and the tip of the nose. This is also the case in a preferred embodiment of an interface that includes the seal and has the side arms described above. The seal can also be made smaller than an indirect nasal interface that can substantially surround the nose and is relatively large on the facial surface, and also does not require a pillow or the like that protrudes into the wearer's nostrils as in a conventional direct nasal interface. The shape of the center of the wearer side of the seal is pre-formed to receive and make sealing contact with the wearer's nasal tip, the lower lateral surface of the nose, and the lower side of the nose and make sealing contact with the wearer's upper lip under the nose. At the same time, since this central portion of the seal is flexible, the internal pressure of the gas presses the seal against these parts of the nose to enhance the seal, and the seal further conforms to the shape of these parts of the nose (with relatively minor shape changes or deformations for many wearers). Despite being flexible, the seal also has elasticity or a memory to return to this pre-formed shape so as to maintain this pre-formed shape. Also, since the seal has this pre-formed shape to receive and contact the lower part of the wearer's nose and the upper lip, the seal can be effective even when the gas flow rate through the mask is relatively low and only a relatively low internal pressure of the gas is generated in the seal against the nose, for example, at a flow rate below about 4 cm H2O. The left and right side wall portions of the flexible center on the wearer side, or at least the upper sections of the left and right side wall portions, have a shape that protrudes outward, i.e., a convex shape (away from the inside of the seal), on the opposite side of the seal. These outwardly protruding, i.e., convex, upper sections on the opposite side of the seal contact the wrinkles or depressions at the junction between the bottom of both sides of the nose and the face, and in this region, assist in avoiding upward leakage of air pressure towards the eyes.Under the pressure of the gas within the seal, the face is deformed (pushed) outwardly in this area to enhance this seal.

[0026] Also, the seal in at least a preferred embodiment maintains its shape or structure even when not in use or not under internal gas pressure. Thus, when a user first begins to use a mask incorporating the seal of the present invention, it is visually relatively clear to the user how to position or orient the mask on the face. From its shape, the method of positioning an indirect nasal mask on the face is relatively clear, as is also the method of positioning with respect to a direct nasal interface including a nasal pillow or the like that enters the wearer's nostrils. However, for at least some new users, the method of positioning may not be immediately obvious with respect to a mask having a seal that engages only below the nose, does not cover the nose, and has no portion that enters the nose. For this type of mask, the preformed shape seal of the present invention makes it clearer how to position the seal, and thus the mask, on the face. Therefore, the mask can be used more intuitively.

[0027] Other The seal can be useful, for example, at air pressures in the range of about 0.5 to about 30 cm H2O, particularly for respiratory interfaces for CPAP therapy.

[0028] Definitions As used herein, the terms "wearer" or "user" mean a person of average adult size or within that range.

[0029] As used herein, the terms "height", "width", and "depth" with respect to an interface, mask, or seal mean substantially vertical, horizontal in the lateral direction, and horizontal from front to back, respectively, when passing through or in relation to the interface, mask, or seal when worn by an upright user.

[0030] As used herein, the term "concave" means a depression (or recess) of any shape, and "convex" has a similar meaning, although not simply mathematically convex.

[0031] As used herein, the term "comprising" means "consisting at least in part of". When interpreting statements in this specification and the claims that include "comprising", other features, or features preceded by this term, may also be present. Related terms such as "comprise" and "comprises" are similarly interpreted.

[0032] Any reference in this specification to prior art is not, and should not be taken as, an admission that such prior art forms part of the common general knowledge in the field of endeavor in any country in the world, or as a suggestion of any kind.

[0033] Embodiments of the present invention will be described by way of example and not with the intention of limitation, with reference to the accompanying drawings.

Brief Description of the Drawings

[0034]

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DETAILED DESCRIPTION OF THE INVENTION

[0035] Overview FIG. 1 is a schematic diagram of a CPAP system 10 for providing a heated and humidified air flow to a user U through an interface 11 that the user wears and is connected to the continuous positive airway pressure (CPAP) system 10 by a conduit or tube 12.

[0036] The humidification chamber 14 has a thermally conductive base that contacts the heating plate 16 of the humidifier 17 and humidifies the air stream. The conduit 12 is connected to the outlet 13 of the humidification chamber 14 and carries the humidified air to the user interface 11. The humidifier 17 includes a controller 18, such as, for example but not limited to, a microprocessor-based controller that executes computer software instructions stored in a relevant memory. The controller 18 receives input commands from a plurality of sources including a user input interface 19, such as a dial or touch screen, that enables the user U to set predetermined values for the humidity, temperature, or other characteristics of the humidified air supplied to the user. The controller 18 also receives inputs from one or more other sources, such as temperature and / or flow rate sensors 20 and 21 connected through a connector 22 to communicate, for example, with the controller 18 and / or a heating plate temperature sensor 23. In response to the user-set humidity or temperature value, the controller 18 determines when and / or at what level the heating plate 16 should be activated to suitably heat the water contained in the humidification chamber 14.

[0037] As the water in the chamber is heated, water vapor begins to fill the volume of the chamber above the water surface. The water vapor is discharged from the outlet 13 of the humidification chamber by the flow of air that is provided from a supply 25, such as a blower 27, and enters the humidification chamber 14 through the inlet 26. The blower 27 can be a variable speed fan or can include a variable pressure regulator. The blower 27 draws in air through the inlet 28. The blower can be controlled, for example, by the controller 29 or the controller 18. The controller can control the blower rotation speed, adjustment pressure, etc. according to any suitable criteria. For example, the controller can respond to an input from the controller 18 and a user-set value (e.g., a preset value) of the pressure and / or fan rotation speed that can be set by the user input interface 19 (e.g., a dial).

[0038] The conduit 12 can include a heater, such as a heater wire, to heat the conduit wall and reduce condensate of the humidified gas within the conduit.

[0039] The seals and interfaces of the present invention can be used in a CPAP system as described above, or instead, in other forms of respiratory systems, such as VPAP (variable positive airway pressure) systems, BiPAP (bi-level positive airway pressure) systems, etc., or together with a ventilator, regardless of whether they are humidified, and in this specification, generally, by way of example only, CPAP therapy will be described with reference to it.

[0040] FIG. 2 is a perspective view of a user U wearing the interface 11 of an embodiment of the present invention, and FIG. 3 is an exploded view showing the components of the interface. The interface includes a mask that includes a seal 30 and a frame 31. The interface also includes a headgear 32 that secures the mask to the wearer. Generally, the interface also includes a short flexible supply conduit or tube 33, such as from the mask, from a central connection portion on the front side of the mask, which conduit is connected to the supply conduit 12 of a CPAP or other respiratory system. The conduit 33 can be connected to the mask via a hollow elbow 34, which elbow can pivot relative to the frame, so that the path of the conduit relative to the position of the mask on the patient's face can be adapted to the position when the patient lies down.

[0041] The mask may include a restricted flow outlet (or bias flow outlet) 35 for providing a washout of gas from the interface. The outlet 35 can be in the form of an assembly of small openings. The outlet can be provided in the elbow 34 as shown, in the frame, or at other locations of the interface.

[0042] Seal Figs. 5 - 12 show embodiments of the seal. As described above, the side surface that contacts the face of the seal, i.e., the wearer side surface, includes a flexible lower nose receiving concave central portion 39 (see particularly Fig. 5), which central portion is pre - formed in a shape such that it receives the tip of the nose, the lower side surface of the nose, and the nasal base and forms a seal contact with the wearer's face by making a seal contact with the upper lip, and positions an aperture 40 for gas flow under the wearer's nostrils. The flexible lower nose receiving central portion includes an upper wall portion 41 that contacts the tip of the wearer's nose, an inwardly spaced lower wall portion 42 that contacts the upper lip under the wearer's nose, and left and right side wall portions 43 and 44 that contact the lower side surfaces on the left and right of the wearer's nose.

[0043] The upper wall portion 41 and the lower wall portion 42 are each symmetric about separate axes A and B in the height h (see Fig. 5) direction of the seal (see Fig. 6). These axes A and B are spaced apart from each other in the depth d direction of the seal, for example, by about 1 to about 3 cm or about 1.5 to about 2.5 cm. In other words, the lower wall portion 42 under the outlet aperture is closer to the left and right most rear tips of the seal than the upper wall portion 41. The left and right side wall portions 43 and 44 extend away from each other from the aperture 40. The angle between the left and right side wall portions 43 and 44 can be, for example, about 20 to about 60 degrees or about 30 to about 50 degrees.

[0044] The lower edge 40a of the aperture 40 is spaced rearward in the depth direction of the seal compared to the upper edge 40b of the aperture.

[0045] In at least a preferred embodiment, the seal has a hollow interior that is filled with air under positive pressure during use.

[0046] The soft lower nose receiving concave central portion has a thin wall thickness, for example, having a wall thickness in the range of about 0.1 to about 0.5 mm, or about 0.1 to about 0.3 mm, or about 0.2 to about 0.3 mm. At the same time, and being flexible and conformable, but in at least a preferred embodiment, the lower nose receiving concave central portion also has elasticity or memory to this shape, so that even when not under positive air pressure from within the seal, it has or maintains this pre-formed shape.

[0047] The material from which at least the thin-walled flexible central portion of the seal is formed can be a soft stretchable material such as, for example, a silicone material, or alternatively a TPE (thermoplastic elastomer). In a preferred form, the seal is an integral component, and all of the described parts and portions thereof are integrally formed from such a material, for example, by injection molding. However, in an alternative embodiment, only the wearer side of the seal may be formed from such a material and bonded to a more rigid shell that is coupled to or integrally formed with the frame of the interface. Alternatively, the seal can be a seal filled with a foam or gel.

[0048] Generally, the width of the seal is greater than the height of the seal. In at least some embodiments, the overall width of the seal can be about 5 to about 10 cm, or about 6 cm to about 8 cm. In at least some embodiments, the overall height of the seal can be less than about 5 cm, or less than about 4.5 cm.

[0049] The aperture 40 can be elongated in the width direction of the seal. The aperture 40 can be substantially trapezoidal in a plan view (viewed from above). In at least some embodiments, at least a portion of the periphery of the aperture includes a rim thickened inside the seal.

[0050] An interface (the interfaces of FIGS. 2 and 3) including the described seal, worn by a user and through which a positive-pressure air flow passes, FIG. 4A is a longitudinal cross-sectional view, FIG. 4B is a cross-sectional view taken along line I-I of FIG. 4A, and FIG. 4C is a longitudinal cross-sectional view taken along line II-II of FIG. 4B. The pre-formed shape defined between the flexible upper wall, lower wall, and side wall portions 41-44 at the center of the wearer side of the seal receives and makes a sealing contact therewith against the wearer's nasal tip, the lower side surface of the nose, and the underside of the nose (see particularly FIGS. 4A and 4B). For many wearers, the seal naturally conforms or matches to the shape of these portions of the wearer's nose with relatively minor shape changes or deformations even without the positive pressure of the internal gas flow, i.e., before the positive pressure is applied. The pressure of the internal gas flow within the seal presses the seal against these portions of the wearer's nose. For other wearers, the pressure of the internal gas flow within the seal causes a greater shape change of the seal to conform to the shape of the wearer's nose.

[0051] As shown in the figures, the seal does not seal a flat portion of either the nasal bridge or the cartilage of the nasal sill between the nasal tip and the nasal bridge.

[0052] In at least the illustrated embodiment, the upper wall portion 41 above the aperture 40 includes an upper concave section 41a (see particularly FIG. 9) within a greater overall concave of the flexible central portion of the wearer side of the seal, which is concave in both the height and width of the seal, and specifically receives the tip of the nose. This upper concave section 41a has an intermediate wall thickness, and this portion is thicker than the remaining portion of the central portion of the wearer side of the seal, but thinner than the left and right outer stabilizing portions of the wearer side of the seal as described below, or thinner than the outside of the seal. For example, the wall thickness can range from about 0.4 or 0.5 mm to about 1 or 2 mm. The upper concave section 41a can extend from the upper edge 40b of the seal outlet aperture to or towards the upper periphery of the seal. The upper concave section can be symmetric about the axis in the height direction of the seal. Above this slightly thick wall thickness section 41a, the thickness of the upper wall section 41 at 41b preferably becomes thinner, for example by a tapered wall section, so as to return to the same thin wall thickness as the lower wall and side wall portions 42-44 at the center of the wearer side of the seal.

[0053] Therefore, the wall of the wearer side of the seal of the preferred embodiment described as such is pre-formed (before being worn) to be close to an S-shape in a central longitudinal cross-section (see FIG. 11). That is, the upper wall portion 41, particularly at 41a, is concave to receive the tip of the wearer's nose, and the lower wall portion 42 is convex and makes a cushioned contact with the upper lip under the wearer's nose, and these upper and lower portions are joined by the aperture. In the preferred embodiment, the S-shape is considered to be a shape with the top cut off, and the upper wall portion 41 may not be more convex than the concave of the lower wall portion. Also, considering the cross-sectional view, the seal has a substantially U-shape (see FIG. 7).

[0054] In at least the illustrated embodiments, the left and right side wall portions 43 and 44, or at least the upper sections 43a and 44a of the left and right side wall portions 43 and 44, have an outwardly projecting or convex shape or bulge (away from the inside of the seal) on the opposite side of the seal. These outwardly projecting or convex upper sections 43a and 44a on the opposite side of the seal are generally above the aperture in the height direction of the seal as shown. These convex upper sections contact the corners of the nose tip, or the wrinkles or depressions at the junctions between the bottom of both sides of the nose and the face, and in this region, can assist in preventing air pressure from leaking upward towards the eyes. Under the pressure of the gas within the seal, these convex upper sections deform (push) outwardly and / or expand against the corners of the nose tip to enhance this sealing. The outwardly projecting or convex sections 43a and 44a can be disposed between the left and right outer stabilizing portions 53 and 54 (described in more detail below) and the upper concave section 41a of the flexible central portion on the wearer side of the seal. The seal can be pre-formed with outwardly projecting or convex sections 43a and 44a on the wearer side. The convex sections 43a and 44a are preferably convex in both the height and width of the seal. The walls of these convex sections 43a and 44a are similar to the remaining portion of the central portion on the wearer side of the seal, but can be thinner than the left and right outer stabilizing portions on the wearer side of the seal or thinner than the outside of the seal as will be described later. The wall thickness can be in the range of, for example, about 0.1 to about 0.5 mm, or about 0.1 to about 0.3 mm, or about 0.2 to about 0.3 mm.

[0055] In an alternative embodiment, the single aperture 40 may be replaced by two small apertures (e.g., separated by a slightly thickened bridging portion therebetween), and the rims around the edges of each of them are turned back and placed on the entrances to the wearer's nostrils, i.e., they enter the nostrils slightly, for example, by about 0.1 to about 3 mm.

[0056] In at least some embodiments, the wearer side of the seal includes left and right outer stabilizing portions 53 and 54 that extend beyond or connect across the left and right side wall portions 43 and 44 of the flexible central portion, and contact the wearer's face adjacent to the lower lateral sides of the alae on the left and right sides of the nose (see particularly FIG. 4C). These outer stabilizing portions 53 and 54 are flexible or compliant, but are relatively less so (or relatively stiffer) than the more flexible lower nose receiving central portion of the seal. For example, these left and right outer stabilizing portions 53 and 54 may have a wall section that is thicker than the wall section of the lower nose receiving central portion (see FIG. 12). Their wall thickness can be in the range of, for example, about 0.5 mm to about 1 or 2 mm. The angle between these left and right outer stabilizing portions can be, for example, about 30 to about 180 degrees, or about 70 to about 150 degrees. The left and right outer stabilizing portions 53 and 54 can assist in stabilizing or positioning the seal on the wearer's face, and in particular, can assist in stabilizing the seal or interface against rotation about the horizontal axis during wear.

[0057] Since the seal is being adjusted, the junctions or transitions in the wall thickness on both sides of the seal between the inner edges 53a and 53b of these left and right outer stabilizing portions 53 and 54 (see FIG. 12) and the central portion of the more flexible walls 43 and 44 of the seal can be positioned at or adjacent to the junction between the lower side of the nose and the face adjacent to the nose during interface wear.

[0058] The seal includes an outer-facing side that faces the wearer side, and this outer-facing side is less flexible or stiffer compared to at least the central portion of the wearer side of the seal, and can be less flexible or stiffer than both the central portion and the left and right outer stabilizing portions of the wearer side of the seal. For example, the wall thickness of the left and right outer portions on the outside of the seal can be thicker than the central portion of the patient contact side of the seal, or thicker than both the central portion and the left and right stabilizing portions.

[0059] The outer-facing side of the seal includes left and right stabilizing portions 63 and 64 that are less flexible and are adapted to contact the face adjacent to the lower lateral side of the alae nasi on the left and right sides of the nose during wearing. The hollow interior of the seal can extend between these left and right side portions 63 and 64 of the outer-facing side of the seal and the left and right portions 53 and 54 of the wearer side of the seal. The angle between the left and right portions 63 and 64 of the outer-facing side of the seal can be, for example, greater than about 20 to about 90 degrees, or about 30 to about 60 degrees. These left and right portions may be formed of the same material as the wearer side of the seal, such as a silicone material, and the wall thickness can be, for example, about 3 mm to about 5 mm. These integral left and right stabilizing portions 63 and 64 provide a seal that enhances stability against rotation on the face, for example, due to the pulling force of a tube.

[0060] In some embodiments, the outer-facing side of the seal connects to the upper peripheral portion, lower peripheral portion, and outer tip peripheral portions 65 - 68 of the wearer side of the seal, and the wall thickness tapers from the outer-facing side of the seal to the wearer side of the seal, for example, by a tapered wall section. In particular, in the illustrated embodiment, the bridging portion 65a (see FIGS. 5 and 7) between the outer-facing side of the seal and the top of the upper wall section 41 has a thin wall section, so this portion is also flexible or adapts to the depth of the seal and helps to adapt to different nose heights (from the face to the tip of the nose). The wall thickness of the bridging portion can be, for example, similar to the wall thickness of the flexible lower wall portion and side wall portions 42 - 44 at the center of the wearer side of the seal.

[0061] In at least some embodiments, the left and right peripheral portions 67 and 68 of the seal at the left and right outer tips of the seal that contact the face during wearing include a generally linear portion that bridges the upper peripheral portion 65 and the lower peripheral portion 66 of the seal.

[0062] In the illustrated embodiment, the outer-facing side of the seal includes an opening 70 for passing gas flow into and out of the hollow interior of the seal. Generally, the rim around the opening 70 and the seal wall 71 are substantially thicker and relatively harder than the flexible seal portion of the seal.

[0063] Frame Figs. 13 - 16 show the interface of an embodiment of the present invention. The interface includes the seals of Figs. 5 - 12. The frame (and elbow) can be formed to be harder than the seal.

[0064] In the illustrated embodiment, the seal 30 is attached to the frame 31 by an elastically flexible and stretchable rim 71 around an aperture 70 on the outward side of the seal that engages to cover the upper side of a complementary configuration such as a rim on the wearer side of the frame 31 around a passage through the frame from inside the elbow 34. Thus, the seal 30 and the frame 31 together form an enclosure having a gas inlet that extends from the CPAP system and the aperture 40 through the seal to the wearer.

[0065] In the illustrated embodiment, the seal 30 is attached to an auxiliary frame portion having a rim 81, namely a boss 31b, which engages, for example by snap fit, into a mating aperture 82 in the central portion 31c of the main frame portion 31 as shown. On the seal side of the boss 31b, it has a peripheral flange 83 with a slightly larger diameter. Also, the depth of the rim 81 of the boss is deeper than the depth of its receiving aperture 82 in the central frame portion 31c, and when the boss 31b is in its home position within the frame portion 31a, an annular space is defined between the inner side or the wearer side of the central portion 31c of the main frame portion 31a and the boss flange 83 around the boss, into which the rim 71 of the seal fits, and the rim 71 of the seal is extended over the flange to attach the seal to the frame (see FIGS. 3, 15, and 16). The inner surface of the rim 71 of the seal includes features such as lips and / or channels, which can engage with features such as channels and / or lips on the frame to removably fix the seal to the frame. Alternatively, the seal can be attached to the frame, for example, by a clip portion or similarly by over-moulding onto a rim that attaches to the frame. In the illustrated embodiment, the plane of the rim 71 of the seal is substantially vertical when an upright user wears the mask, but in another embodiment, the seal can be formed such that the plane of the seal rim is at an acute angle to the horizontal, for example in the range of 45 to 90 degrees, while as shown in FIGS. 13 to 17, the body of the seal includes a frame with side arms and is still oriented towards the user's face when worn.

[0066] The frame 31 includes side arms 31d which extend outwardly (away from each other), rearwardly and upwardly at a shallow angle, beyond the left and right tips of the seal, and along the left and right cheeks and in particular the cheekbones of the wearer as shown in Fig. 2, and are connected to the headgear and can hold the seal against the wearer's face. Such side arms 31d may be longer than their depth or thickness, and may be elastically and flexibly connected to the frame, and / or may be elastically flexible along their length (in the width direction rather than the height direction), and may extend to a location between the wearer's ear and eye and / or to approximately the temple of the wearer where the side arm is connected to the headgear. In a preferred embodiment, the length of the side arm is from about 100 mm to about 150 mm. The shape of the side arms 31d and / or the angle between them is such that the side arms resting on the left and right cheeks and in particular the cheekbones of the wearer assist in stabilizing the interface against rotation about a horizontal axis during wear. The side arms 31d may be integrally formed with the frame from a plastic material, for example by injection molding. The side arms are elastically flexible towards and away from the wearer's face in a substantially horizontal plane (during wear) and can adapt to different face sizes, but may be relatively inflexible in a substantially vertical plane. As shown in Fig. 13 (only), the side arms include an aperture or notch extending in the length direction of the side arm, preferably in the length direction of the major portion of the length of the side arm, which can increase this elastic flexibility of the side arms towards and away from the wearer's face, but maintains a relatively inflexible state in a substantially vertical plane (during wear).

[0067] Preferably, the side arms 31d include a softer material on at least the face of the side arm facing the wearer or over the entire periphery of the side arm to soften the contact between the wearer's face and the side arm, which can be removed for cleaning purposes.

[0068] At the outer end, the side arm 31d includes a connector portion that removably connects the side arm to the headgear. In a preferred form, the end of each side arm includes a hook 85, particularly a hook portion that opens upward, and enters a loop 95 of the headgear.

[0069] In a preferred embodiment, the interface does not include a T-shaped part that extends upward (when worn) from the frame and connects to the headgear on the wearer's forehead.

[0070] Instead of the side arms as shown (or for shorter side arms), the ends of the headgear straps can be attached to the mask frame (or shorter side arms) on both (left and right) sides via stiffer strap ends, and the strap ends are terminated by the attachment mechanism at the mask, and the attachment mechanism allows movement in a substantially horizontal plane but not in a substantially vertical plane, such as a hook that engages a vertically upright slot in the mask frame.

[0071] As described above, the frame can include an elbow 34 connected to an opening through the frame. The elbow can be a swivel elbow. In a preferred form, the connection of the elbow to the frame provides both rotation and swiveling of the elbow with respect to the frame. For example, the connection can include a ball joint connection to the frame, so that the elbow can swivel about axes parallel and perpendicular to its connection to the mask. The elbow includes a part ball end 34a (see FIG. 3), which can snap fit into a socket opening 31e of the frame portion 31b.

[0072] The elbow 34 is connected to the end of a length portion of the flexible tube 33. The other end of the flexible tube 33 terminates at a connector 33a. The elbow 34 preferably defines an angle between 0° and about 90°, or about 30° and about 60°, between the flow in the conduit 33 and the flow through the connection to the mask.

[0073] As described above, the elbow may include a gas wash vent 35 that may include a plurality of holes that pass from the inside to the outside of the elbow. The vent aperture is preferably located on the outside of the bend of the elbow, substantially on the line of the gas flow path exiting the mask. Alternatively, the gas wash vent may be provided, for example, on the frame.

[0074] Headgear Figure 17 shows an interface comprising an interface mask of the present invention and an embodiment of headgear suitable for use therewith. The headgear includes a rear strap 91 that extends around the back of the wearer's head and a top strap 92 that extends over the top of the wearer's head. The rear strap 91 may extend around the lower rear of the wearer's head, particularly over the lower occipital bone. The top strap 92 may be a crown strap or a forehead strap.

[0075] The headgear may be formed, at least in part, from a soft flexible material, such as a foamed material coated with a cloth such as BREATH-O-PRENE material. The headgear may be formed, for example, by cutting the headgear from a sheet material by cutting with a blade or high-frequency cutting. In one embodiment, the edge of the headgear is thermoformed, i.e., compressed under heat to form a rounded edge. That is, heat and pressure are applied along the edge of the headgear, compressing the opposing outer surfaces of the headgear material towards each other at the edge and thermally bonding them. This may be done, for example, in a single operation by cutting the outline of the headgear shape in the sheet material, simultaneously or alternatively, with the thermoforming to define the rounded edge of the headgear, or by first cutting the headgear for shaping and then rounding the edge in a second operation. Alternatively, a rounded edge or any joint in the headgear may be formed, for example, by ultrasonic or high-frequency welding.

[0076] In at least some embodiments, the length of the rear strap 91 and / or the top strap 92 is adjustable. For example, the top strap may be formed in two parts, one of which terminates in a loop 95, and the other of which terminates in a tongue 97, which passes through the loop and back onto the strap portion to be secured by a hook or loop fastener panel on the end of the tongue or a tab from its end, and a loop or hook panel on the strap or on the cloth covering the tab (adjustment of the loop and tongue) to secure the length portion of the top strap. The rear strap may have buckle 96 and tongue 97 for length adjustment on the left and right sides as shown, or instead on one side or in the center, as shown in FIG. 19. In a preferred form, the buckle 96 is formed separately from a different and relatively rigid material, such as a plastic material, for example by injection molding, and is attached to the end of the soft strap by welding, such as ultrasonic welding, or other suitable means. FIG. 18A is an enlarged end view, and FIG. 18B is an enlarged side view of the end of the buckle 96 of the headgear portion or strap. Each buckle (or fastener portion) includes a first portion 96a attached to the soft flexible material of the headgear and a second free portion 96b including an open loop for receiving the tongue end of the strap therethrough.

[0077] In a preferred form, as described above, the headgear includes loops 95 on each of the left and right sides of the headgear at a location positioned between the eyes and ears when the headgear is worn, and with each loop receiving the hook end 85 of the side arm of the interface as described above. The hook end of the side arm is attached directly to the headband formed by the rear and top straps without using a side strap extending from the headband towards the mask. In this or other embodiments, alternatively, the side arm is attached to the headgear by, for example, a releasable clip or hook, or a hook and loop attachment.

[0078] FIG. 20 is a view similar to FIG. 17, including an embodiment of the headgear similar to FIGS. 17 - 19, but in this embodiment, it is an alternative top strap configuration. In this embodiment, the top strap is not formed of a soft, flexible material such as a foam material covered with the same material as the rest of the headgear, cloth, etc., but is formed of a non-foamed plastic material such as a plastic strap that can be relatively non-extensible in the longitudinal direction (however, flexible in other ways to conform to the shape of the head). Again, the top strap may be formed in two parts, one of which terminates in a tongue with an aperture 97a, and the other terminates in a buckle with a button 97b, through which the tongue 97 can pass adjustably, and on the upper side of the button, the aperture of the tongue can be snap-fitted to adjust the top strap and thus fix its length. Optionally, the soft material may be provided on the user side or part of the top strap for the user's comfort.

[0079] The frame side arms are attached directly to the headgear, as shown, to a headband as shown consisting of rear and top straps, without side straps going from the headband towards the frame, and the edge of the headgear is heat formed, i.e., compressed under heat, to form a rounded edge as described above, to reduce the "floppiness" of the soft headgear and maintain its headband shape. In an embodiment, the headgear can be worn (held like a brimless cap when lifted or flipped over the head) by holding the frame against or near the seal. The headgear can be removed or taken off by a similar reverse motion. Other aspects of the headgear and frame that help reduce the "floppiness" of the soft headgear and maintain its headband shape include a relatively high density foam used to form the headgear, relatively long side arms of the frame that extend substantially towards or adjacent to the wearer's cheeks when worn, and / or the stiffness of the connection between the side arms and the headband (tight tolerances or a tight connection of the headgear around the connector) (tight loop 59 around hook 85) and / or the stiffness of the connection of the upper and rear straps of the headgear (tight loop around buckle 96). Such aspects of the headgear allow the headgear to be worn (held like a brimless cap when lifted or flipped over the head) by holding the frame against or near the seal. The headgear can be removed or taken off by a similar reverse motion.

[0080] The seals and masks of the present invention can be used in conjunction with other forms of headgear, such as headgear having two straps attached on both sides to a mask, i.e., headgear including upper and lower straps on the left and right sides. The frame of such an interface embodiment may or may not include side arms as described above. The upper left and right straps may pass downwardly between the wearer's eyes and ears (when the headgear is worn), and the lower left and right straps may extend from the lower rear of the head to below the ears to the mask (and attach to the mask on each side below the upper strap). Alternatively, the upper and lower straps may be joined to a rigid yoke, for example, before attachment to the mask frame or integral with the mask frame. Such headgear may have buckles and tongues, loops and tongues (as described above) or other adjustment parts along a portion of their length or at the connection of the straps to the mask, on the upper or lower straps or on both sides. In a less preferred embodiment, the upper strap may be attached to the top of a T-shaped part extending upwardly from the frame to the wearer's forehead. In another embodiment, again, the headgear may include a single strap that passes around the rear of the head, loops around or through the mask on one side and returns to the mask on the other side. Such a headgear strap may be elastic or stretchable and / or may have a length adjustment device (such as a buckle and tongue, loop and tongue, etc.) at the rear or side or at the connection of the headgear to the mask on one side or both sides. Such a variant of headgear may also include a headband strap.

[0081] Side hinge of the seal Figures 21, 22, 23, and 24 show two embodiments of the mask of the present invention, and each of the left and right outer portions of the outer side surface of the seal includes a more flexible portion in the middle of their lengths. These more flexible portions enable the lateral movement of the remaining portion of the seal relative to the portion of the seal including the rim 71 connected to the frame of the interface. Therefore, these flexible portions allow for a certain degree of movement of the frame of the mask, thereby breaking the contact of the seal with the face and causing air leakage. The cause is the lateral force on the mask when the wearer is sleeping on their side, for example, with one side of the wearer's face on a pillow. This lateral force has little tendency to move the seal itself, especially the side surface of the seal that contacts the face, i.e., the wearer's side surface, laterally, and may have a tendency to push the frame laterally.

[0082] In the illustrated embodiments, the more flexible portion includes pleats 101 / 102 directed inwardly into the seal on the side wall of the outer side surface of the seal. The pleats have wall sections that are thinner than the outer side surface of the seal on both sides of the pleats. In the embodiments of FIGS. 21 and 22, the inwardly directed pleats 101a and 101b extend partially across the width of the hollow interior of the seal. In the embodiments of FIGS. 23 and 24, the inwardly directed pleats 102a and 102b extend partially into the depth of the hollow interior of the seal. The embodiments of FIGS. 21 - 24 are the same as the embodiments of FIGS. 2 - 17 in other parts.

[0083] Summary The seal of the present invention includes left and right low-flexibility stabilizing outer portions adapted to contact the face adjacent to the lower lateral side of the ala nasi on the left and right sides of the nose when worn. The seal is highly stable against rotation on the face, particularly around the width axis of the seal, which can be caused by, for example, the pulling force of a tube. This rotation can break the seal and cause leakage. This is the case even if the seal does not seal against the delicate nasal bridge or does not extend at least to a significant extent, such as more than about 1 cm, across any flat portion of the cartilage of the nasal sill between the nasal bridge and the tip of the nose. This is also the case in a preferred embodiment of an interface that includes a seal and side arms as described above. The flexible central left and right side wall portions on the wearer's side, or at least the upper sections of the left and right side wall portions, have a convex shape that protrudes outward (away from the inside of the seal) on the opposite side of the seal. These outwardly protruding or convex upper sections on the opposite side of the seal contact the wrinkles or depressions at the junction between the bottom of both sides of the nose and the face, and in this region, assist in avoiding upward leakage of air pressure towards the eyes. Under the pressure of the gas within the seal, they deform (push) the face outward in this region, enhancing this seal. The pre-formed or pre-structured yet still flexible and conforming shape of the seal of the present invention naturally conforms or matches to many wearers with relatively little shape change or deformation, and results in a seal where the positive pressure of the internal gas flow can enhance the seal. Similarly, an effective seal with minimal or no leakage in a small or thin mask can be achieved for many wearers without the need for the mask to include a conventional direct nasal interface pillow or the like that protrudes into the wearer's nostrils. An effective seal can be achieved with a relatively low gas flow rate through the mask and a relatively low internal pressure of the gas within the seal against the nose. Also, at least in a preferred embodiment, the seal maintains its shape or structure even when not worn or when not under internal gas pressure, making it more intuitive for the user regarding how to position or locate the mask on the face.

[0084] Other headgear Figures 25-29 illustrate the arrangement configuration of a headgear that provides advantageous force vectors for patient interfaces such as obstructive sleep apnea (OSA) masks and respiratory masks by being placed behind the head and covering the ears partially or completely. See, for example, Figure 25.

[0085] The headgear 200 may include a lightweight stretchable fabric, such as Lycra or a similar material that provides more substantial fabric support. See, for example, Figure 28.

[0086] In some configurations, the ear-covering section 210 can be made of a very fine and lightweight stretchable fabric to maximize the wearer's comfort. In some such configurations, a more substantial fabric 220 (which may be heavier and / or less stretchy) can be used to form part or all of the rest of the headgear. See, for example, Figure 26.

[0087] The lamination of fabrics 211 and 212 having different properties or characteristics (e.g., different stretch levels) in some regions can provide additional structure for stability and ease of fitting. See, for example, Figure 26.

[0088] In one or more embodiments, there is a wider attachment point 230 on the front (e.g., wider than equivalent conventional masks / headgear), which stably holds the mask seal and suppresses or prevents rocking on the face. The attachment point 230 can be the same width as a substantial or significant portion of the height of the mask seal 280. See, for example, Figure 25.

[0089] In some embodiments, there may be a generally circular or halo notch 240 surrounding the crown of the head for stability and to reduce bulk. See, for example, Figure 26.

[0090] In some configurations, the more substantial fabric extends beyond the front of the ear, providing further structure to the headgear and preventing bunching above the ear. See, for example, Figure 26.

[0091] In one configuration, the headgear 200 (or the body of the headgear) can be composed of only a lightweight stretchable fabric that widens in the area 250 that goes towards the back of the head. See, for example, FIG. 27.

[0092] In one configuration, the headgear 200 can be composed of a lightweight stretchable fabric that widens towards the back of the head and includes a section of substantially more material around the rear portion 250 to provide structure. See, for example, FIG. 27.

[0093] In one configuration, the headgear can be adjustable at the top 260 of the loop. See, for example, FIG. 28.

[0094] In one configuration, the headgear 200 can have a thermoformed section that holds the ear covering 270 at a desired distance, which can be a relatively short distance in some embodiments, away from the ears. See, for example, FIG. 29.

[0095] In one such configuration, the headgear 200 includes a curved plastic piece 270 that is placed at a desired distance away from the ears, and can be made such that the headgear can be more easily slid over the ears. See, for example, FIG. 29.

[0096] FIGS. 30 - 36 show an arrangement configuration 300 of a stretchable headgear that uses the jaw and the top of the head as fixed points.

[0097] In one configuration, the main structure 300 is composed of an elastic strap that widens around the jaw 310 and the back 320 of the head, preferably in a circular knit. The wide section can be composed of a stretchable fabric such as Lycra or a similar fabric. See, for example, FIGS. 30 and 31.

[0098] In one configuration, there can be an adjustment point 330 that is placed above the ears. See, for example, FIGS. 30 and 31.

[0099] Some of the advantages of such an arrangement are that the headgear 300 is lightweight, does not go under the ears, thereby assisting in fitting, and is less bulky than conventional headgear.

[0100] In some configurations, additional straps 340 connect the mask 380 to the headgear 300. These can also be made adjustable to improve the customization of the fit. See, for example, FIGS. 30 and 31.

[0101] There can be single or multiple mask attachment straps 340 on each side. FIG. 32 shows an option with a single strap.

[0102] In some configurations, the headgear 300 can be tightened to function as a chin strap, thereby assisting people who breathe through their mouths. See, for example, FIG. 32.

[0103] The headgear 300 is fixed around the head and preferably does not rely on the mask seal 381 as a fixed point. That is, the headgear 300 can remain in place even if the seal 381 is not attached. Advantageously, such an arrangement isolates the force of the seal from the force holding the headgear 300. This arrangement shows an advantageous difference compared to conventional headgear.

[0104] Such a configuration functions well in combination with a full-face mask 380 (FIG. 33) or a nasal mask 380 (FIGS. 30, 32, 35, and 37). See, for example, FIG. 33.

[0105] In at least one embodiment, the rear strap 320 can be split. In some such arrangements, the split portion of the strap 320 can include a rigid component 350. See, for example, FIG. 34.

[0106] In one configuration, the mask attachment strap 340 can include loops 341 that rest on one or more hooks 342 or other retaining structures on each side of the mask frame 382. See, for example, FIGS. 35 and 36.

[0107] FIGS. 37-47 show an arrangement 400 of a headgear preferably including a single elastic strap 410 that loops around the top of the head and has a rigid or flexible plastic strap 420 that is attached to the elastic strap above the ears and extends around the lower back of the head.

[0108] In one configuration, the rigid or flexible plastic strap 420 terminates at an attachment point 430 to the elastic strap above the ears. See, for example, FIGS. 37 and 46.

[0109] The rigid or flexible plastic strap 420 can be permanently attached by sewing, welding, riveting, crimping, or clipping, or a combination of these methods. In a preferred configuration, the rigid or flexible plastic strap 420 is attached by sewing. See, for example, FIGS. 39-41 and 46.

[0110] The elastic strap 410 can also be made of several straps connected at the end points 430 of the rigid or flexible strap 420 above the ears.

[0111] In at least one embodiment, the single elastic strap 410 can be attached or fed through several loop holes 431 so that the strap can be oriented at a desired angle, so that the strap is placed on the top of the head and redirected towards the holes 431 to provide an optimal position for attachment to the mask 480.

[0112] The strap 410 may remain unattached through the loop holes 431-433 at the attachment points to enable an adjustment function. See, for example, FIGS. 42 and 43.

[0113] The rigid or flexible plastic strap 420 can be coated by, for example, a fabric or foam 440. See, for example, FIGS. 45 and 47.

[0114] The plastic part 420 can be formed by punching or injection molding, etc. In a preferred embodiment, the plastic part or strap 420 is formed by injection molding.

[0115] The plastic part 420 can be textured to feel good / soft.

[0116] In one configuration, the elastic strap 410, preferably knitted, may be all of the same width or diameter, or may be wider in a plurality of portions 411 for comfort. See, for example, FIG. 41.

[0117] In some configurations, the elastic strap 410 can have an elastic region 412 and a non-elastic region 413. See, for example, FIG. 40.

[0118] Other seals FIGS. 48 - 62 show a nose seal 500 having a stabilizing flap 510 to transfer the load on the seal surface to the cheek instead of the lip and bridge of the nose. This allows the seal 500 to be made thinner (e.g., 0.1 mm - 0.5 mm) and, in some configurations, to bulge to conform around the nose, resulting in a leak-free and comfortable seal. The silicone seal 500 can have a thicker support section 530 (e.g., a portion with a thicker wall thickness or other structure that increases stiffness compared to other parts of the seal 520).

[0119] The stabilizing flap 510 can be configured to be more rigid than the seal, but still flexible enough to conform to the facial features without causing pressure sores. See, for example, FIG. 51.

[0120] The size and shape of the flap 510 can be such that it can be placed alongside the nose, preferably in the cheek area. See, for example, FIG. 48.

[0121] Preferably, the stabilizing flap 510 has no single point or small area where pressure or load is applied, in order to distribute the seal's load force evenly, or more evenly across the face compared to an existing nasal mask.

[0122] Preferably, the flap 510 is wide enough to minimize upward movement of the seal in the direction of the eyes and to provide lateral stability at the nose. See, for example, FIG. 49.

[0123] In some configurations, the inner seal 520 can be placed like a conventional nasal seal that covers the bridge of the nose and around both sides of the nose, and covers the upper lip. See, for example, FIG. 48.

[0124] The flap 510 can be integrated with the seal surface 520 and made of the same material in at least one embodiment. In such an embodiment, each of the flaps 510 has one or more thick sections 530 to provide stiffness and thin sections 540 for flexibility, with a desired or optimal balance of stability and weight.

[0125] In some configurations, the seal surface 520 can avoid contact with the bridge of the nose. This can be combined with an integrated stabilizing flap 510 or a separate stabilizing flap 510. See, for example, FIG. 62.

[0126] In some configurations, the flap 510 can be divided so that it fits better on the face or better fits some geometric shapes of the face. See, for example, FIG. 61.

[0127] In some configurations, the flap 510 can be made hollow so that it better conforms to various geometric shapes of the face. See, for example, FIGS. 57 - 59.

[0128] In at least one embodiment, instead of or in addition to using a thick wall section of a soft elastomeric material, the seal 500 can be overmolded onto a plastic part 550 having an arm 551 that further provides stiffness to the flap. In such an arrangement, the plastic part 550 can serve as a reinforcement member. See, for example, FIG. 61.

[0129] In some configurations, the flap 510 can be separated from the seal portion 520. The flap 510 can be made of a different material, such as breathoprene, thermoformed breathoprene or foam, or foamed silicone, etc.

[0130] The seals of FIGS. 48 - 62 function well in combination with the headgear arrangements 200 and 400 of the headgear described herein, respectively, for any two-point headgear, such as FIGS. 25 - 29 and FIGS. 37 - 47.

[0131] FIG. 63 shows a flexible mask frame 600 for an OSA mask with an arm 610 that, when the headgear 630 is tightened, clamps the frame 600 inwardly against the seal 620. For example, the arm 610 can extend outward (away from the user's face) to the attachment portion 611. With such an arrangement, the end portions 611 of the generally or substantially U-shaped central portion 612 of the mask frame 600 bend inward to clamp the seal 620. Such an arrangement helps hold the seal 620 more snugly against the nose, thereby improving the seal and / or stability.

[0132] Other seals FIGS. 64 - 82 show an inflatable nasal seal 700 that is placed under the nose and includes wings 710 that extend around both sides of the nose, preferably below the eyes, avoiding the nasal bridge. See, for example, FIG. 79.

[0133] In one configuration, the wing 710 is shaped to rest on both sides at the transition between the nose and the cheek for stability, prevent leakage, and allow movement of the seal 700.

[0134] In one configuration, the seal 700 is small enough for the tip of the nose to be exposed, thus accommodating noses of different sizes. See, for example, FIG. 82.

[0135] In one configuration, the seal portion 720 can be relatively thin (such as about 0.1 mm to 0.5 mm), but have a thicker structure (for example, higher stiffness) in the central region 721. See, for example, FIG. 68.

[0136] In one configuration, the downward pressure applied to the lower seal surface 720 pulls the wing 710 inward in the pinching movement, providing a better seal and a more secure fit. See, for example, FIG. 73.

[0137] In one configuration, the outer wall of one or more portions of the seal (such as the wing 710) is substantially thicker than the inner wall 720, expands inward, and presses the expanded portion 720 against the face. See, for example, FIG. 68.

[0138] In one configuration, there is a single opening 730 for air flow to the outer nostrils. However, in other configurations, there can be two or more openings 730 for air flow to the outer nostrils.

[0139] In one configuration, the seal 700 can include a nose tip portion that is contacted by or partially or completely covered by the expanded portion to provide a better seal. See, for example, FIG. 71.

[0140] The nose seal 700 can be used in combination with a mask frame 740 that is sufficiently flexible to pinch and tighten the seal toward the nose to provide a more snug fit and a better seal. See, for example, FIG. 75.

[0141] As described above, in some configurations, the nose seal 700 may have separate openings 731 and 732 to each external nostril. See, for example, FIG. 76.

[0142] In at least one configuration, the inflatable nose seal 700 has only the pad 750 under the nose and not the wings. See, for example, FIG. 77.

[0143] In some configurations, the nose seal 700 may have small angled protrusions 760 at the upper and / or lower corners of the seal 700, which may assist in the stability of the seal. See, for example, FIGS. 79 - 80.

[0144] One or more of the configurations of the nose seal 700 of FIGS. 64 - 82 can be configured to work well with the headgear 400 described herein with respect to FIGS. 37 - 47.

[0145] The above has described the invention, including preferred forms, and alternative and modified forms, as will be apparent to those skilled in the art, are intended to be incorporated within the scope of this specification.

Claims

1. A nose seal for a mask interface, the seal including a face-contacting side or wearer-side, the wearer-side including a flexible lower-nose-receiving central portion having a preformed concave shape for receiving and sealingly contacting the tip, underside and base of the wearer's nose and for sealingly contacting the upper lip and for positioning an aperture for gas flow below the wearer's nares, the flexible central portion including left and right sidewall portions to the left and right of the aperture for contacting the left and right undersides of the wearer's nose, the left and right sidewall portions or the left and right sidewall portions a nose seal, wherein at least an upper section of a portion has an outwardly projecting or convex shape (away from an interior of the seal) opposite the seal, and wherein the seal includes an outwardly facing side of the seal that faces the wearer side, the outwardly facing side of the seal including left and right stabilizing outer portions terminating in left and right outer tips that contact the face adjacent the lower lateral sides of the nostrils on the left and right sides of the nose when worn, the left and right outer portions of the seal being less flexible or stiffer than at least the central portion of the wearer side of the seal.

2. 2. The nose seal of claim 1, wherein the outwardly projecting or convex shape of the left and right sidewall portions, or the upper sections of the left and right sidewall portions, is positioned to seal against creases or depressions at the junctions between the bottom of the sides of the nose and the face.

3. 3. The nasal seal of claim 2, wherein the outwardly projecting or convex shape of the left and right side wall portions, or the upper sections of the left and right side wall portions, is above the aperture in a height direction of the seal.

4. A nasal seal according to any one of claims 1 to 3, wherein the left and right outer portions of the outward facing side of the seal are less flexible or stiffer than both the lower nose receiving central portion and the left and right outer stabilizing portions of the wearer facing side of the seal.

5. 5. The nasal seal of claim 4, wherein the left and right outer portions of the outward facing side of the seal have a thicker wall thickness than both the central portion and the left and right stabilizing portions of the wearer facing side of the seal.

6. 6. The nasal seal of claim 5, wherein a hollow interior of the seal extends between left and right side portions of the outward facing side and left and right side portions of the wearer facing side of the seal.

7. 7. A nasal seal according to any one of claims 1 to 6, wherein the outward facing side of the seal is joined to an upper peripheral portion, a lower peripheral portion and an outer tip peripheral portion of the wearer facing side of the seal, and wherein a wall thickness tapers from the outward facing side of the seal to the wearer facing side of the seal.

8. A nasal seal according to any one of claims 1 to 7, wherein a bridging portion between the outward facing side of the seal and a top wall section on the wearer side of the seal is flexible or conforms to the depth of the seal.

9. 9. A nasal seal according to any one of claims 1 to 8, wherein the left and right peripheral portions of the seal at the left and right outer extremities of the seal that contact the face when worn include substantially linear portions bridging the upper and lower peripheral portions of the seal.

10. 10. A nasal seal according to any one of claims 1 to 9, wherein the outwardly facing side of the seal includes an aperture for gas flow in and out of a hollow interior of the seal, and the seal is connected or attached to a body or frame by a rim around the aperture on the outwardly facing side of the seal.

11. A nasal seal according to any preceding claim, wherein a lower edge of the aperture is spaced rearwardly relative to an upper edge of the aperture in the direction of the depth of the seal.

12. 12. A nasal seal according to any one of claims 1 to 11, wherein the seal has a hollow interior, at least inside the flexible lower nose-receiving concave central portion on the wearer-facing side of the seal, which is filled with gas under positive pressure in use.

13. A nasal seal according to any one of claims 1 to 12, wherein the flexible lower nasal receiving concave central portion has the preformed shape when not under positive internal gas pressure from within the seal.

14. A nose seal according to any preceding claim, wherein the flexible lower nose receiving concave central portion has elasticity or memory of returning to the preformed shape.

15. A nasal seal according to any preceding claim, wherein the seal is wider in a width direction of the seal than it is tall in a height direction of the seal.

16. 16. A nose seal according to any one of claims 1 to 15, wherein the flexible lower nose receiving central portion includes an upper wall portion above the aperture for contacting the tip of the wearer's nose, and a lower wall portion below the aperture and rearward of the upper wall portion for contacting the upper lip below the wearer's nose.

17. 17. A nasal seal according to claim 16, wherein portions of the lower wall below the aperture are closer to the left and right most rear extremities of the seal than the upper wall portions.

18. 18. A nasal seal according to claim 16 or 17, wherein the upper wall portion, lower wall portion, and left and right side wall portions have distinct and compound curved shapes.

19. A nasal seal according to any one of claims 16 to 18, wherein the upper and lower wall portions are symmetrical about separate axes spaced apart from one another in the depth direction of the seal and in the height direction of the seal.

20. 20. The nasal seal of claim 19, wherein the axes are spaced apart from one another across the depth of the seal by about 1 to about 3 cm.

21. A nasal seal as claimed in any one of claims 16 to 20, wherein the upper wall portion includes an upper concave section within the greater overall concavity of the flexible central portion of the wearer-facing side of the seal, specifically for receiving the nasal tip, the upper concave section being concave in both the height and width of the seal.

22. 22. The nasal seal of claim 21, wherein the upper concave section extends from an upper edge of the aperture.

23. 23. A nasal seal according to claim 21 or 22, wherein the wall thickness of the upper concave section is thicker than the remainder of the central portion of the wearer-facing side of the seal.

24. 24. A nasal seal according to any one of claims 21 to 23, wherein the upper concave section has an intermediate wall thickness that is thicker than the remainder of the central portion of the wearer-facing side of the seal but thinner than left and right outer stabilising portions of the wearer-facing side of the seal or thinner than the outer sides of the seal.

25. A nasal seal according to any one of claims 16 to 24, wherein the lower wall portion below the exit aperture is convex in the height of the seal and concave in the width of the seal.

26. A nasal seal according to any one of claims 16 to 25, wherein the left and right side wall portions extend away from each other on either side of the aperture.

27. A nasal seal according to any preceding claim, wherein the aperture is elongated in the width direction of the seal.

28. A nasal seal according to any preceding claim, wherein at least a part of the periphery of the aperture includes a thickened rim.

29. 29. A nose seal as claimed in any one of claims 1 to 28, wherein the wearer-facing side of the seal includes left and right outer stabilising portions outboard of left and right sidewall portions of the flexible central portion for contacting the wearer's face adjacent both left and right sides of the nose, and the outer stabilising portions are flexible but less flexible than the lower nose receiving central portion of the wearer-facing side of the seal.

30. 30. The nasal seal of claim 29, wherein the left and right outer stabilizing portions have thicker wall sections than the wall sections of the central portion.

31. 31. The nose seal of claim 30, wherein a junction or transition in wall thickness on either side of the seal between inner edges of the left and right outer stabilizing portions and the flexible central portion is positioned to rest at or adjacent the junction between the underside of the nose and the face adjacent the nose.

32. 32. A nasal seal according to any one of claims 1 to 31, wherein the left and right outer portions of the outwardly facing side of the seal each include a more flexible portion intermediate their length to allow lateral movement of at least the face-contacting or wearer-side of the seal relative to a part of the seal adapted to be connected to a frame of an interface.

33. 33. The nasal seal of claim 32, wherein the more flexible portion comprises inwardly directed pleats in a side wall of the outwardly facing side of the seal.

34. 34. A nasal seal according to claim 33, wherein the inwardly directed pleats extend partially across the width of the hollow interior of the seal.

35. 34. A nasal seal according to claim 33, wherein the inwardly directed pleats extend partially into the depth of the hollow interior of the seal.

36. A nasal seal according to any preceding claim, wherein at least the flexible central portion of the seal is formed from a silicone material.

37. A nasal seal according to any preceding claim, wherein substantially all of the seal is formed from a silicone material.

38. A nasal seal according to any preceding claim, wherein all of the portions of the seal are integrally formed such that the seal is a one-piece component.

39. 39. An interface comprising a seal as claimed in any one of claims 1 to 38 and comprising a frame including left and right side arms, the side arms extending outwardly (away from each other) and rearwardly beyond the left and right tips of the seal and extending upwardly at a shallow angle and along the left and right cheeks and particularly the cheekbones of the wearer to connect to headgear to hold the interface on the wearer's face.

40. 40. The interface of claim 39, wherein the frame side arms have a length that extends to a point between the wearer's ears and eyes and / or to approximately the temples.

41. 41. An interface as claimed in claim 39 or 40, wherein the side arms of the frame are angled between them to rest on the wearer's left and right cheeks and particularly the cheekbones to help stabilise the interface against rotation about a width axis of the interface.

42. An interface according to any one of claims 39 to 41, wherein the side arms of the frame comprise a soft material at least on the surface facing the wearer.

43. An interface according to any one of claims 39 to 41, wherein the interface does not include a T-piece that runs upwardly from the frame and connects to headgear at the wearer's forehead.

44. An interface according to any one of claims 39 to 43, wherein the side arms of the frame include connector portions at their outer ends for releasably connecting the frame to headgear.

45. An interface according to any one of claims 39 to 44, comprising a swivel elbow connected to the inlet opening.

46. 46. ​​An interface according to any one of claims 39 to 45, also including headgear including a rear strap that extends around a rear of the wearer's head and a top strap that extends over the wearer's head.

47. 47. The interface of claim 46, wherein the rear strap extends around a lower rear of the wearer's head.

48. 48. The interface of claim 46 or 47, wherein the top strap is a crown strap or a forehead strap.

49. An interface as claimed in any one of claims 46 to 48, wherein the left and right side arms of the frame extend for direct attachment to a headband formed by the rear strap and / or the top strap.

50. An interface according to any one of claims 46 to 49, wherein the rear strap and / or the top strap are adjustable in length.

51. An interface according to any one of claims 46 to 50, wherein the headgear is formed at least in part from a foam material covered with fabric.

52. 1. A nasal seal for a mask interface, the seal having a hollow interior adapted to be filled with gas under positive pressure during use, the seal including a wearer side, the wearer side including a flexible lower-nose receiving central portion preformed in a shape to receive and in sealing contact with the tip, lower surface and base of the wearer's nose and in sealing contact with the upper lip, and to position an exit aperture for gas flow below the wearer's nares, the wearer side of the seal also including integral left and right outer stabilizing portions oriented rearwardly for contacting the wearer's face adjacent the lower lateral sides of the nostrils on the left and right sides of the nose and outboard of the flexible central portion, the outer stabilizing portions being flexible but less flexible than the central portion of the seal.

53. 1. A nasal seal for a mask interface, the seal comprising a hollow interior adapted to be filled with gas under positive pressure during use, the seal comprising a wearer side, the wearer side including a flexible lower nose receiving central portion shaped to receive and sealably contact the lower and upper lip of the nose and to position an aperture for gas flow below the wearer's nares, an upper wall portion above the aperture that is concave in both height and width of the seal to contact the tip of the wearer's nose, a lower wall portion below the aperture and rearward of the upper wall portion that is convex in the height of the seal and concave in the width of the seal to contact the upper lip below the wearer's nose, and left and right side wall portions for contacting the left and right lower surfaces of the wearer's nose.

54. 1. A nose seal for a mask interface comprising a face-contacting or wearer side, said wearer side being flexible and conforming when worn, but prior to wear comprising: - generally U-shaped when considered in transverse cross section to receive the tip of the wearer's nose and an underside adjacent said tip; A generally S-shaped configuration when considered in a central longitudinal section, including an upper concave portion that receives the tip of the wearer's nose, a lower convex wall portion that cushioningly contacts the wearer's upper lip, and apertures for gas flow that are aligned with the wearer's nostrils. The nose seal is preformed to include the shape of

55. a seal including a wearer-side portion including a flexible lower nose receiving central portion preformed in a shape to receive and make sealing contact with the tip, lower surface and base of the wearer's nose and with the upper lip, and to position an exit aperture for gas flow below the wearer's nares, the wearer-side portion of the seal also including integral left and right outer stabilizing portions oriented rearwardly and outboard of the central portion for contacting the wearer's face adjacent the lower lateral sides of the nostrils on the left and right sides of the nose, the outer stabilizing portions being flexible but less flexible than the lower nose receiving central portion of the seal; a frame including side arms that extend outwardly (away from each other) and rearwardly beyond the left and right extremities of the seal and extend upwardly at a shallow angle and along the left and right cheeks of the wearer to connect to headgear that holds the seal against the wearer's face; and Headgear including a rear strap that extends around the rear of the wearer's head and a top strap that extends over the top of the wearer's head. Including, the interface.

56. a seal including a wearer-side surface, the wearer-side surface including a flexible lower-nose-receiving central portion preformed in a shape to receive and make sealing contact with the tip, lower surface, and base of the wearer's nose and with the upper lip, and to position an exit aperture for gas flow below the wearer's nares; a frame including side arms extending outward (away from each other) and rearward beyond the left and right extremities of the seal and connected to headgear that holds the seal on the wearer's face, the headgear including at least a rear strap that extends around the rear of the wearer's head and optionally also at least a top strap that extends over the top of the wearer's head, with no headgear side straps extending from the rear (or top) straps to the frame; and Headgear including at least a rear strap and, optionally, also at least a top strap, wherein the headgear is not soft and has a tendency to maintain its worn shape when not worn. The interface containing

57. 57. The interface of claim 56, wherein edges of the headgear are thermoformed.

58. 1. Headgear for a respiratory interface, the headgear being formed of a soft, flexible material and including at least one fastening component, the fastening component being formed of a relatively more rigid material different from and secured to the soft, flexible material.

59. 60. Headgear according to claim 58, wherein the at least one fastening component is formed from a plastic material.

60. 60. Headgear according to claim 59, wherein the at least one fastening component is injection molded from a plastic material.

61. Headgear according to any one of claims 58 to 60, wherein the at least one fastening element is attached to or points towards an end of a strap portion of the headgear.

62. 62. Headgear according to any one of claims 58 to 61, wherein the at least one fastening component includes a first portion attached to the soft, flexible material of the headgear and a second free portion including an open loop for receiving a tang end of a strap.

63. Headgear according to any one of claims 57 to 61, wherein the at least one fastening part is attached to the soft, flexible material of the headgear by welding.

64. Headgear according to any one of claims 59 to 63, wherein the at least one fastening component is attached to the soft, flexible material of the headgear by ultrasonic welding.

65. Headgear according to any one of claims 58 to 62, wherein the soft, flexible material is a fabric covered foam material.

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