Nasal seals and breathing interfaces

Abstract

To provide a nasal seal and / or interface that provides a useful option for the general public or medical professionals. A nasal seal for a respiratory interface includes a flexible lower nasal receiving central portion having a preformed concave shape to receive and seal against the tip, lower surface, and base of the nose and to seal against the upper lip, and to position apertures for gas flow below the wearer's nares. The seal may have resilience or memory to return to this preformed shape.

Description

[Technical Field]

[0001] The present invention relates generally to nasal seals for respiratory interfaces, and to interfaces that include nasal seals, including either masks or masks and headgear. [Background technology]

[0002] Respiratory interfaces are used to provide one or more respiratory gases to a user under positive pressure, such as air in CPAP therapy. Nasal interfaces deliver gases to the nose.

[0003] The seal of an indirect nasal interface substantially surrounds the nose, contacting the upper lip, the face on either side of the nose, and the bridge of the nose. The indirect nasal interface may have a relatively large portion on the face, which may exert pressure on the bridge of the nose, and the frame of the interface may include a T-shaped piece that connects to headgear on the wearer's forehead, which generally interferes with the wearing of, for example, eyeglasses.

[0004] Direct nasal interfaces are generally less intrusive because they generally have a smaller portion on the face and do not include a T-shaped piece, however, direct nasal interfaces generally include nasal pillows or the like that enter the wearer's nostrils to ensure an effective seal. Summary of the Invention [Problem to be solved by the invention]

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

[0006] In general, in one aspect, the invention includes a nose seal for a mask interface, or a mask interface including a nose seal, the seal including a face-contacting side or wearer-side, the wearer-side side including a flexible lower-nose-receiving central portion having a preformed concave shape to receive and seal against the tip, lower sides, and base of the nose and to seal against the upper lip, and to position apertures for gas flow below the wearer's nares, the flexible central portion including left and right side wall portions to the left and right of the apertures that contact the left and right lower sides of the wearer's nose, the left and right side wall portions, or at least upper sections of the left and right side wall portions, having outwardly projecting or convex shapes (away from the interior of the seal) on opposite sides of the seal, and the seal including an outward-facing side of the seal facing the wearer-side, the outward-facing side of the seal that seals against the lower lateral sides of the nostrils on the left and right sides of the nose when worn. and left and right stabilizing outer portions terminating in left and right outer extremities adapted to contact the face adjacent the wearer's side flanks, wherein the left and right outer portions of the seal are less flexible or stiffer than at least a central portion of the wearer's side of the seal.

[0007] The left and right sidewall portions of the flexible central portion of the seal extend away from the aperture. In at least some embodiments, the outwardly projecting or convex shapes of the left and right sidewall portions, or the upper sections of the left and right sidewall portions, are positioned to seal against creases or depressions at the junction between the bottom of the sides of the nose and the face. These outwardly projecting or convex upper sections on opposite sides of the seal are generally above the aperture in the seal height direction.

[0008] In at least some embodiments, the outward-facing side of the seal connects to an upper peripheral portion, a lower peripheral portion, and an outer tip peripheral portion on the wearer-facing side of the seal, and the wall thickness tapers from the outside of the seal to the wearer-facing side of the seal. In at least some embodiments, the left and right peripheral portions of the seal at the left and right outer tips of the seal that contact the face when worn include substantially linear portions that bridge the upper and lower peripheral portions of the seal.

[0009] Generally, the lower edge of the aperture is spaced rearwardly relative to the upper edge of the aperture in the direction of the depth of the seal.

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

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

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

[0013] In at least some embodiments, the top wall portion, bottom wall portion, and left and right side wall portions may have complex curved shapes (and, to the extent that each has approximate major planes that are not coplanar).

[0014] The flexible upper, lower, and side wall portions of the central wearer-facing portion of the seal have a preformed shape to receive and seal against the tip of the wearer's nose, the lower surface of the nose, and the underside of the nose. The flexible central portion of the seal on the wearer's side can have this preformed shape even when not under positive air pressure from within the seal. Because it is flexible, it conforms flexibly, but, at least in preferred embodiments, it also has resilience or memory to return to this preformed shape. In other words, the seal has a "structure" to maintain this preformed shape. Therefore, even before internal gas flow through the seal creates positive pressure within the seal, for many wearers, the seal naturally conforms or conforms to the shape of these portions of the wearer's nose with only relatively little shape change or deformation. The pressure of the internal gas flow in 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 also causes the seal to change its shape more significantly to conform to the shape of the wearer's nose.

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

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

[0017] In at least some embodiments, the wearer-facing side of the seal also includes left and right outer stabilizing portions outside the left and right side wall portions of the flexible central portion that contact the wearer's face adjacent the inferior lateral sides of the nostrils on the left and right sides of the nose, and which outer stabilizing portions are flexible or compliant, but relatively less flexible (or relatively stiffer) than the more flexible inferior nasal support central portion on the wearer-facing side of the seal. For example, these left and right outer stabilizing portions can have thicker wall sections than the wall sections of the inferior nasal support central portion.

[0018] The seal can be adjusted so that the junction or transition in wall thickness on either side of the seal between the inner edges of these left and right outer stabilizing portions and the flexible central portion of the seal rests at or adjacent to the junction between the underside of the nose and the face adjacent to the nose.

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

[0020] The interface, of which the seal may be a part, includes a frame to which the seal may be attached. In at least some embodiments, the seal and frame together form an enclosure having a gas inlet opening to the breathing system and an aperture to the wearer through the seal.

[0021] In a preferred embodiment, the frame includes side arms that extend outward (away from each other) and rearward beyond the left and right tips of the seal, and extend upward at a shallow angle along the wearer's cheeks and, in particular, cheekbones to connect to headgear and hold the seal to the wearer's face. Such side arms may be longer than deep or thick, and may be resiliently connected to a central portion of the frame and / or may be resiliently flexible along their length, and may extend to a point between the wearer's ears and eyes and / or approximately to the wearer's temples, where they connect to the headgear. The shape of the frame side arms and / or the angle between them are such that the side arms rest against the wearer's cheeks and, in particular, cheekbones, helping to stabilize the interface against rotation about a horizontal axis when worn.

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

[0023] In a preferred embodiment, the interface extends upward from the frame (when worn) and does not include a T-piece for connecting to headgear at the wearer's forehead.

[0024] In one embodiment, headgear suitable for use with the interface assembly of the present invention includes 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. 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 less flexible left and right stabilizing outer portions adapted to contact the face adjacent the lower lateral sides of the nostrils on the left and right sides of the nose when worn. The seal provides increased stability against rotation on the face, for example, due to the drag force of the tube. This rotation could rupture the seal and cause leakage. This is true even in the preferred embodiment of the interface including the seal and the side arms described above, even though the seal does not seal against the delicate bridge of the nose or extend, at least significantly, for example, more than about 1 cm across any flat portion of the nasal ridge cartilage between the bridge and tip of the nose. The seal also allows the nasal interface to be smaller than indirect nasal interfaces, which substantially surround the nose and can be relatively large on the face, and does not require pillows or the like that protrude into the wearer's nostrils as with conventional direct nasal interfaces. The shape of the center of the wearer's side of the seal is preformed to receive and seal against the tip of the wearer's nose, the lower surface of the nose, and the underside of the nose, and to seal against the wearer's upper lip below the nose. At the same time, because this central portion of the seal is flexible, the internal pressure of the gas presses the seal against those portions of the nose, enhancing the seal, and the seal also conforms to the shape of those portions of the nose (with relatively little change in shape or deformation for most wearers). Despite being flexible, the seal also has resilience or memory to return to this shape so that it retains this preformed shape. And because the seal has this preformed shape to receive and contact the wearer's lower nose and upper lip, the seal can be effective even when the gas flow rate through the mask is relatively low, creating only relatively low internal gas pressure within the seal against the nose, such as a flow rate below about 4 cm H2O. The left and right sidewall portions of the flexible center facing the wearer, or at least the upper sections of the left and right sidewall portions, have outwardly protruding or convex shapes (away from the interior of the seal) on opposite sides of the seal. These outwardly projecting or convex upper sections on the opposite side of the seal contact the creases or depressions at the junction between the bottom of the sides of the nose and the face and help to prevent air pressure from leaking upward towards the eyes in this area.Under pressure of the gas within the seal, the face deforms (pushes) outward in this area, enhancing the seal.

[0026] Additionally, because the seal, at least in preferred embodiments, maintains its shape or configuration even when not worn or under internal gas pressure, when a user first begins using a mask including the seal of the present invention, it is visually relatively clear to the user how to position or position the mask on their face. While it is relatively clear from its shape how to position an indirect nasal mask on the face, and also how to position it for a direct nasal interface that includes nasal pillows or the like that enter the wearer's nostrils, it may not be immediately obvious to at least some new users how to position a mask that includes a seal that only engages the lower part of the nose but does not cover or enter the nose. For this type of mask, the preformed shape of the seal of the present invention makes it more clear how the seal, and therefore the mask, needs to be positioned on the face. Therefore, the mask may be more intuitive to use.

[0027] others The seal may be useful, for example, at air pressures ranging from about 0.5 to about 30 cm H2O, particularly for respiratory interfaces for CPAP therapy.

[0028] definition As used herein, the term "wearer" or "user" means a person of or within the size range of an average adult.

[0029] As used herein, the terms "height," "width," and "depth" in reference to an interface, mask, or seal mean approximately vertical, side-to-side horizontal, and front-to-back horizontal through or in relation to the interface, mask, or seal when worn by an upright user.

[0030] As used herein, the term "concave" means any shape of depression (or recessed), 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 the specification and claims containing "comprising," other features or features preceded by this term may also be present. Related words such as "comprise" and "comprises" are to be interpreted similarly.

[0032] The reference herein to any prior art is not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the general knowledge prevailing in the field of endeavor in any country throughout the world.

[0033] Embodiments of the present invention will now be described, by way of example and not limitation, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0034] [Figure 1] 1 is a schematic diagram of a system for providing a flow of heated, humidified gas to a user, for example, a continuous positive airway pressure system. [Figure 2] FIG. 1 is a perspective view of a person wearing a patient interface according to an embodiment of the present invention. [Figure 3] FIG. 3 is an exploded view showing the components that make up the interface of FIG. 2. [Figure 4A] FIG. 4A is a longitudinal cross-sectional view of the interface of FIGS. 2 and 3 worn by a patient and with positive air pressure flow through the interface. [Figure 4B] FIG. 4B is a cross-sectional view taken along line II of FIG. 4A. [Figure 4C] FIG. 4C is a longitudinal cross-sectional view taken along line II-II of FIG. 4B. [Figure 5] FIG. 1 is a perspective view of an embodiment of a seal. [Figure 6] FIG. [Figure 7] FIG. [Figure 8] FIG. 10 is a view of the underside of the seal. [Figure 9] FIG. 10 is a view of the wearer side of the seal. [Figure 10] FIG. 1 is a view of the outside of the seal. [Figure 11] FIG. [Figure 12] FIG. [Figure 13] FIG. 2 is a side view of the interface. [Figure 14] FIG. 1 is a top view of the interface. [Figure 15] FIG. 1 is a longitudinal section through the interface. [Figure 16] FIG. 1 is a cross-sectional view through the interface. [Figure 17] 1 shows an interface with an embodiment of headgear. [Figure 18A] FIG. 1 is a close-up end view of the loop or buckle end of the strap. [Figure 18B] FIG. 18 is an enlarged side view of the loop or buckle strap end of the headgear of FIG. 17. [Figure 19] 18A and 18B are views of the rear of the headgear of FIG. 17 showing the two buckles of FIGS. 18A and 18B, respectively, with the tongue strap ends passing through the buckles. [Figure 20] 17, including an embodiment of headgear similar to that of FIGS. 17-19, but with an alternative top strap configuration in this embodiment. FIG. [Figure 21] FIG. 1 is a perspective view of an interface (headgear excluded) of an embodiment of the present invention in which the seal includes a side hinge. [Figure 22] FIG. 22 is a cross-sectional view of the interface of FIG. 21. [Figure 23] FIG. 10 is a perspective view of an interface (headgear excluded) of another embodiment of the present invention, in which the seal includes a side hinge. [Figure 24] FIG. 24 is a cross-sectional view of the interface of FIG. 23. [Figure 25] 1 illustrates an embodiment of headgear that covers the user's ears and may include at least two sections with different material properties. [Figure 26] 1 illustrates an embodiment of headgear that covers the user's ears and may include at least two sections with different material properties. [Figure 27] 1 illustrates an embodiment of headgear that covers the user's ears and may include at least two sections with different material properties. [Figure 28] 1 illustrates an embodiment of headgear that covers the user's ears and may include at least two sections with different material properties. [Figure 29] 1 illustrates an embodiment of headgear that covers the user's ears and may include at least two sections with different material properties. [Figure 30] 10 shows an embodiment of elastic headgear that uses the chin and crown as fixation points. [Figure 31] 10 shows an embodiment of elastic headgear that uses the chin and crown as fixation points. [Figure 32] 10 shows an embodiment of elastic headgear that uses the chin and crown as fixation points. [Figure 33] 10 shows an embodiment of elastic headgear that uses the chin and crown as fixation points. [Figure 34] 10 shows an embodiment of elastic headgear that uses the chin and crown as fixation points. [Figure 35] 10 shows an embodiment of elastic headgear that uses the chin and crown as fixation points. [Figure 36] 36 shows an attachment structure for connecting a mask frame to an elastic strap of any one of the embodiments of FIGS. 30 to 35. [Figure 37]1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 38] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 39] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 40] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 41] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 42] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 43] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 44]1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 45] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 46] 1 shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head. [Figure 47] FIG. 47A shows an embodiment of headgear that preferably includes a single elastic strap that loops around the top of the head and has a rigid or flexible plastic strap attached to the elastic strap above the ears and extending around the lower back of the head, and FIG. 47B is a cross-sectional view of the plastic strap of FIG. 47A. [Figure 48] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 49] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 50] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 51] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 52] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 53] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 54] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 55] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 56] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 57] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 58] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 59] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 60] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 61] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 62] 10 shows an embodiment of a nose seal having stabilizing flaps that transfer the load of the sealing surface to the cheeks rather than the lips and bridge of the nose. [Figure 63] 1 shows an embodiment of a flexible mask frame for an OSA mask with arms that pinch the frame inward against the seal when the headgear is tightened. [Figure 64] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 65] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 66]1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 67] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 68] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 69] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 70] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 71] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 72] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 73] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 74] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 75] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 76] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 77]1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 78] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 79] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 80] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 81] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. [Figure 82] 1 shows an embodiment of an inflatable nose seal that rests under the nose and includes wings that extend around either side of the nose, preferably under the eyes and away from the bridge of the nose. DETAILED DESCRIPTION OF THE INVENTION

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

[0036] A humidification chamber 14 has a thermally conductive base that contacts a heating plate 16 of a humidifier 17 to humidify the airflow. A conduit 12 connects to an outlet 13 of the humidification chamber 14 to carry the humidified air to a user interface 11. The humidifier 17 includes a controller 18, such as, but not limited to, a microprocessor-based controller that executes computer software instructions stored in associated memory. The controller 18 receives input commands from multiple sources, including a user input interface 19, such as a dial or touchscreen, that allows a user U to set predetermined values ​​for the humidity, temperature, or other characteristics of the humidified air. The controller 18 may also receive input from one or more other sources, such as temperature and / or flow rate sensors 20 and 21 connected through a connector 22 to communicate with the controller 18 and / or a heating plate temperature sensor 23. In response to the user's set humidity or temperature value, the controller 18 determines when and / or at what level to activate the heating plate 16 to appropriately heat the water contained in the humidification chamber 14.

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

[0038] Conduit 12 may include a heater, such as a heater wire, to heat the walls of the conduit and reduce condensation of humidified gas within the conduit.

[0039] The seals and interfaces of the present invention may be used in CPAP systems as described above, whether humidified or not, or alternatively in other forms of breathing systems, such as VPAP (Variable Positive Airway Pressure) systems, BiPAP (Bi-Level Positive Airway Pressure) systems, or in conjunction with ventilators, and will generally be described herein with reference to CPAP therapy, by way of example only.

[0040] FIG. 2 is a perspective view of a user U wearing an interface 11 according to an embodiment of the present invention, and FIG. 3 is an exploded view showing the components of the interface. The interface includes a mask, including a seal 30 and a frame 31. The interface also includes headgear 32, which secures the mask to the wearer. Typically, the interface also includes a short, flexible supply conduit or tube 33 from the mask, such as from a central connection on the front of the mask, which connects 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 can pivot relative to the frame so that the routing of the conduit relative to the position of the mask on the patient's face can be adapted to the patient's sleeping position.

[0041] The mask may include a restricted flow outlet (or bias flow outlet) 35 to provide flushing of gas from the interface. The outlet 35 may be in the form of a collection of small openings. The outlet may be located in the elbow 34 as shown, in the frame, or elsewhere in the interface.

[0042] seal 5-12 illustrate embodiments of the seal. As noted above, the face-contacting or wearer-facing side of the seal includes a flexible, concave, central portion 39 (see particularly FIG. 5) that is pre-shaped to form a seal on the wearer's face by receiving and sealing against the tip, lower surface, and base of the nose and the upper lip, and to position gas flow apertures 40 below the wearer's nares. The flexible, 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 below the wearer's nose, and left and right side wall portions 43 and 44 that contact the left and right lower surfaces of the wearer's nose.

[0043] The upper wall portion 41 and the lower wall portion 42 are symmetrical about separate axes A and B (see FIG. 6) in the direction of the seal height h (see FIG. 5). These axes A and B are spaced apart from each other in the direction of the seal depth d by, for example, about 1 to about 3 cm or about 1.5 to about 2.5 cm. In other words, the lower wall portion 42 below the exit aperture is closer to the rearmost left and right ends 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] A lower edge 40a of the aperture 40 is spaced rearward relative to an upper edge 40b of the aperture in the depth direction of the seal.

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

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

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

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

[0049] The aperture 40 may be elongated across the width of the seal. The aperture 40 may be generally trapezoidal in plan view (viewed from above). In at least some embodiments, at least a portion of the periphery of the aperture includes a thickened rim on the interior of the seal.

[0050] FIG. 4A is a longitudinal cross-sectional view, FIG. 4B is a cross-sectional view taken along line II in FIG. 4A , and FIG. 4C is a longitudinal cross-sectional view taken along line II-II in FIG. 4B of an interface including the described seal (the interface of FIGS. 2 and 3 ) worn by a user and with a positive airflow pressure passing through the interface. A preformed shape defined between the central flexible upper, lower, and side wall portions 41-44 on the wearer's side of the seal receives and seals against the wearer's nasal tip, the underside of the nose, and the underside of the nose (see particularly FIGS. 4A and 4B ). For many wearers, the seal naturally conforms or conforms to the shape of these portions of the wearer's nose with only a relatively small change in shape or deformation, even in the absence or prior to the positive pressure of the internal gas flow. 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 the seal to deform more substantially to conform to the shape of the wearer's nose.

[0051] As can be seen, the seal does not seal against the bridge of the nose or any of the flat areas of cartilage in the nasal ridge between the tip and bridge of the nose.

[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 larger overall concavity of the flexible central portion of the wearer-facing side of the seal, which is concave in both height and width of the seal, specifically receiving the tip of the nose. This upper concave section 41a has an intermediate wall thickness that is thicker than the remainder of the central portion of the wearer-facing side of the seal, but may be thinner than the left and right outer stabilizing portions of the wearer-facing side of the seal, as described below, or thinner than the outer portions of the seal. For example, the wall thickness may range from about 0.4 or 0.5 mm to about 1 or 2 mm. The upper concave section 41a may extend from the upper edge 40b of the seal exit aperture to or toward the upper periphery of the seal. The upper concave section may be symmetrical about the seal's height axis. Above this slightly thicker wall thickness section 41a, the thickness of the upper wall section 41 at 41b preferably decreases, for example by a tapered wall section, to return to the same thin wall thickness as the lower wall and side wall portions 42-44 in the center of the wearer's side of the seal.

[0053] Thus, the wearer-facing wall of the seal of the preferred embodiment so described is preformed (before being worn) to approximate an S-shape in a central longitudinal cross-section (see FIG. 11). That is, upper wall portion 41, particularly at 41a, is concave to receive the tip of the wearer's nose, and lower wall portion 42 is convex to cushion against the upper lip below the wearer's nose, and these upper and lower portions are joined by an aperture. In a preferred embodiment, the S-shape is considered a truncated shape, and upper wall portion 41 may be less convex than the concave shape of the lower wall portion. Also, the seal has a generally U-shape when considered in a transverse cross-section (see FIG. 7).

[0054] In at least the illustrated embodiment, the left and right sidewall portions 43 and 44, or at least the upper sections 43a and 44a of the left and right sidewall portions 43 and 44, have an outwardly protruding or convex shape or ridge on the opposite side of the seal (away from the interior of the seal). These outwardly protruding or convex upper sections 43a and 44a on the opposite side of the seal are generally above the aperture in the seal height direction as shown. These convex upper sections may contact the corners of the nostrils or creases or depressions at the junction between the bottom of the sides of the nose and the face and help prevent air pressure in this area from leaking upward toward the eyes. Under the pressure of gas within the seal, these convex upper sections deform outward (push) and / or expand against the sides of the nostrils, enhancing this seal. 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 of the seal on the wearer side. The seal can be preformed with the 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 the convex sections 43a and 44a are similar to the rest of the central portion of the seal on the wearer side, but can be thinner than the left and right outer stabilizing portions on the wearer side of the seal, as described below, or thinner than the outside of the seal. The wall thickness can range, for example, from about 0.1 to about 0.5 mm, or from about 0.1 to about 0.3 mm, or from about 0.2 to about 0.3 mm.

[0055] In an alternative embodiment, the single aperture 40 may be replaced by two smaller apertures (e.g., separated by a bridge between them, which may be slightly thickened), with a rim around the edge of each of which is inverted and rests at the entrance to the wearer's nostril, i.e., enters the nostril slightly, e.g., by about 0.1 to about 3 mm.

[0056] In at least some embodiments, the wearer-facing side of the seal includes left and right outer stabilizing portions 53 and 54 that extend beyond or connect to the left and right sidewall portions 43 and 44 of the flexible central portion and contact the wearer's face adjacent the inferior lateral sides of the nostrils on the left and right sides of the nose (see, particularly, FIG. 4C ). These outer stabilizing portions 53 and 54 are flexible or pliable, but relatively less so (or relatively stiffer) than the more flexible lower nose support central portion of the seal. For example, these left and right outer stabilizing portions 53 and 54 can have thicker wall sections than the wall sections of the lower nose support central portion (see, for example, FIG. 12 ). Their wall thicknesses can range, for example, from about 0.5 mm to about 1 or 2 mm. The angle between these left and right outer stabilizing portions can be, for example, from about 30 to about 180 degrees, or from about 70 to about 150 degrees. The left and right outer stabilizing portions 53 and 54 can help stabilize or position the seal on the wearer's face, and particularly help stabilize the seal or interface against rotation about a horizontal axis during wear.

[0057] The seal is adjusted so that the junction or transition in wall thickness on either side of the seal between the inner edges 53a and 53b (see FIG. 12) of these left and right outer stabilizing portions 53 and 54 and the central portions of the softer walls 43 and 44 of the seal can rest at or adjacent the junction between the underside of the nose and the face adjacent to the nose when the interface is worn.

[0058] The seal includes an outward-facing side facing the wearer-facing side, which may be less flexible or stiffer than at least a central portion of the wearer-facing side of the seal, and less flexible or stiffer than both the central portion of the wearer-facing side and the left and right outer stabilizing portions of the seal. For example, the outer left and right outer portions of the seal may have a thicker wall thickness than the central portion of the patient-contacting side of the seal, or than both the central portion and the left and right stabilizing portions.

[0059] The outward-facing side of the seal includes less flexible left and right stabilizing portions 63 and 64 adapted to contact the face adjacent the lower lateral sides of the nostrils on the left and right sides of the nose when worn. The hollow interior of the seal may extend between these left and right side portions 63 and 64 of the outward-facing side of the seal and the left and right portions 53 and 54 of the wearer-facing side of the seal. The angle between the left and right portions 63 and 64 of the outward-facing side of the seal may 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 from the same material as the wearer-facing side of the seal, such as a silicone material, and may have a wall thickness of, for example, about 3 mm to about 5 mm. These integral left and right stabilizing portions 63 and 64 provide the seal with increased stability against rotation on the face due to, for example, tube drag forces.

[0060] In some embodiments, the outward-facing side of the seal merges into upper, lower, and outer tip peripheral portions 65-68 on the wearer-facing side of the seal, with the wall thickness tapering from the outward-facing side of the seal to the wearer-facing side of the seal, e.g., by a tapered wall section. In particular, in the illustrated embodiment, the bridging portion 65a (see FIGS. 5 and 7) between the outward-facing side of the seal and the top of the upper wall section 41 has a thin wall section so that this portion is also flexible or adapts to the depth of the seal and helps accommodate different nose heights (from the face to the tip of the nose). The wall thickness of the bridging portion may be similar to the wall thickness of the flexible lower and side wall portions 42-44, for example, in the center of the wearer-facing 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 extremities of the seal that contact the face when worn include substantially linear portions that bridge the upper and lower peripheral portions 65 and 66 of the seal.

[0062] In the illustrated embodiment, the outward facing side of the seal includes an opening 70 for permitting gas flow to and from the hollow interior of the seal. Generally, the rim around the opening 70 and the seal wall 71 are substantially thicker and relatively stiffer than the flexible sealing portion of the seal.

[0063] Frame Figures 13 to 16 show an interface according to an embodiment of the present invention, which includes the seal of Figures 5 to 12. The frame (and elbow) may be formed to be stiffer than the seal.

[0064] In the illustrated embodiment, the seal 30 is attached to the frame 31 by a resiliently flexible and stretchable rim 71 around an aperture 70 on the outward-facing side of the seal that overlays and engages a complementary feature, such as a rim on the wearer-facing side of the frame 31 around the passageway from the interior of the elbow 34 through the frame. Thus, the seal 30 and frame 31 together form an enclosure with a gas inlet for the CPAP system and a gas inlet through the seal to the wearer via an aperture 40.

[0065] In the illustrated embodiment, the seal 30 is mounted to a subsidiary frame portion or boss 31b having a rim 81 that engages, e.g., by a snap fit, with a matching aperture 82 in the central portion 31c of the main frame portion 31 as shown. The seal side of the boss 31b has a peripheral flange 83 of slightly larger diameter. The depth of the boss rim 81 is also greater than the depth of its receiving aperture 82 in the central frame portion 31c, such that when the boss 31b is home within the frame portion 31a, an annular space is defined between the inside or wearer side of the central portion 31c of the main frame portion 31a and the boss flange 83 around the boss, into which the seal rim 71 fits and which allows the seal to be attached to the frame by stretching the seal rim 71 over the flange (see FIGS. 3, 15, and 16). The inner surface of the seal rim 71 may include features, such as lips and / or channels, that engage with features, such as channels and / or lips, on the frame to removably secure the seal to the frame. Alternatively, the seal may be attached to the frame, for example, by clips or by overmolding to a rim that similarly attaches to the frame. In the illustrated embodiment, the plane of the seal rim 71 is approximately vertical when the mask is worn by an upright user; however, in other embodiments, the seal may be formed so that the plane of the seal rim is at an acute angle to the horizontal, such as an angle in the range of 45-90 degrees, while the main body of the seal is still oriented toward the frame, including the side arms, and the user's face when worn, as shown in FIGS. 13-17.

[0066] The frame 31 includes side arms 31d that extend outward (away from each other), backward, and upward at a shallow angle, past the left and right tips of the seal, and along the wearer's left and right cheeks and particularly the cheekbones, as shown in FIG. 2, to connect to the headgear and hold the seal to the wearer's face. Such side arms 31d may be longer than their depth or thickness, and may be resiliently connected to the frame and / or be resiliently flexible along their length (in the width direction, but not in the height direction), and may extend to a point between the wearer's ears and eyes and / or to approximately the wearer's temples where the side arms connect to the headgear. In a preferred embodiment, the length of the side arms is approximately 100 mm to approximately 150 mm. The shape of the side arms 31d and / or the angle between them are such that the side arms that rest against the wearer's left and right cheeks and particularly the cheekbones help stabilize the interface against rotation about a horizontal axis when worn. The side arms 31d may be integrally formed with the frame from a plastic material, for example, by injection molding. The side arms may be resiliently flexible toward and away from the wearer's face in a generally horizontal plane (when worn) to accommodate different sized faces, but relatively inflexible in a generally vertical plane. As shown in FIG. 13 (only), the side arms may include apertures or cutouts extending along their length, preferably along a major portion of their length, to increase this resiliently flexible nature of the side arms toward and away from the wearer's face, while maintaining their relative inflexibility in a generally vertical plane (when worn).

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

[0068] At their outer ends, the side arms 31d include connector portions that removably connect the side arms to headgear. In a preferred form, the end of each side arm includes a hook 85, particularly the upwardly opening hook portion, that fits into a loop 95 on the headgear.

[0069] In a preferred embodiment, the interface does not include a T-shaped piece extending upward from the frame (when worn) for connecting to headgear on the wearer's forehead.

[0070] Instead of the side arms as shown (or with 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 that terminate at the mask by attachment mechanisms, such as hooks that engage vertically upright slots in the mask frame, allowing movement in a generally horizontal plane but not in a generally vertical plane.

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

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

[0073] As mentioned above, the elbow may include a gas flush vent 35, which may include multiple holes passing from the interior to the exterior of the elbow. The vent aperture is preferably located outside the bend of the elbow, substantially in line with the flow path of gas exiting the mask. Alternatively, the gas flush vent may be provided in, for example, the frame.

[0074] headgear 17 shows an interface comprising an embodiment of headgear suitable for use with the interface mask of the present invention. The headgear includes a rear strap 91 that extends around the rear 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 fabric-covered foam material such as Breath-O-Prene. The headgear may be formed by cutting the headgear to a desired shape from a sheet of material, for example, by cutting with a blade or high-frequency cutting. In one embodiment, the edges of the headgear are thermoformed, i.e., compressed under heat to form rounded edges. That is, heat and pressure are applied along the edges of the headgear to compress the opposing outer surfaces of the headgear material at the edges toward each other and thermally bond them. This may be done, for example, by simultaneously cutting the headgear to a desired shape and thermoforming to define the rounded edges of the headgear in one operation, by cutting the outline of the headgear shape in the sheet of material, or alternatively, by first cutting the headgear to a desired shape and then rounding the edges in a second operation. Alternatively, the rounded edges or any joints on 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 top strap 92 is adjustable. For example, the top strap may be formed in two sections, one terminating in a loop 95 and the other in a tongue 97 that passes through the loop and is secured back onto the strap section, allowing the length of the top strap to be secured by a hook or loop fastener panel on or a tab from the end of the tongue and a loop or hook panel on the strap or to the fabric covering the tab (loop and tongue adjustment). The rear strap may have a buckle 96 and tongue 97 for length adjustment on the left and right sides as shown, or alternatively, on one side or in the center, as shown in FIG. 19 . In a preferred form, the buckle 96 is separately formed from a different and relatively rigid material, such as a plastic material, for example, by injection molding, and attached to the end of the soft strap by welding, such as ultrasonic welding, or other suitable means. 18A is an enlarged end view and FIG. 18B is an enlarged side view of the end of a headgear portion or strap buckle 96. 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 tang end of a strap therethrough.

[0077] In a preferred form, as previously described, the headgear includes loops 95 on each of the left and right sides of the headgear at the locations that would be between the eyes and ears when the headgear is worn, each loop receiving a hook end 85 of the side arm of the interface, as described above. The hook ends of the side arms attach directly to the headband, consisting of the back and top straps, without side straps leading from the headband toward the mask. In this or other embodiments, the side arms may alternatively be attached to the headgear by, for example, releasable clips or hooks, or by a hook-and-loop attachment.

[0078] FIG. 20 is a view similar to FIG. 17, including a headgear embodiment similar to FIGS. 17-19, but with an alternative top strap configuration. In this embodiment, the top strap is not formed of the same material as the rest of the headgear, such as a soft, flexible material such as a fabric-covered foam material, but is formed of a non-foam plastic material, such as a plastic strap, which may be relatively inextensible in length (but otherwise flexible to conform to the shape of the head). Again, the top strap may be formed in two sections, one of which terminates in a tongue with an aperture 97a, and the other of which terminates in a buckle having a button 97b, over which the tongue 97a can be adjustably passed, and over which the aperture of the tongue can snap to secure the adjustment of the top strap and therefore its length. Optionally, a soft material may be provided on or in the user's side of the top strap for user comfort.

[0079] In embodiments where the frame side arms are attached directly to the headgear, such as the headband as shown, which is made up of back and top straps with no side straps going from the headband towards the frame, and the edges of the headgear are thermoformed, i.e., compressed under heat, to form rounded edges as described above to reduce the "floppiness" of the soft headgear and maintain its headband shape, the headgear can be donned ("like a cap") by holding the frame at or near the seal (like holding a cap by its bill when lifted or turned over the head). The headgear can be removed or doffed by the same action in reverse. Other aspects of the headgear and frame that help reduce the "flex" of soft headgear and help it maintain its headband shape include the relatively high-density foam used to form the headgear, the relatively long side arms of the frame that extend substantially toward or adjacent the wearer's cheeks when worn, and / or the stiffness of the connections between the side arms and the headband (tight tolerances or tight connections of the headgear around the connectors) (tight loops 59 around hooks 85) and / or the stiffness of the connections of the headgear's top and rear straps (tight loops around buckles 96). Such headgear aspects allow the headgear to be worn ("cap-like") by holding the frame at or near the seal (like holding a cap by its bill when lifted or flipped over the head). The headgear can be removed or doffed by the same actions in reverse.

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

[0081] Seal side hinge Figures 21-24 show two embodiments of the mask of the present invention, in which the left and right outer portions of the outward-facing side of the seal each include a more flexible section midway along their length. These more flexible sections allow for lateral movement of the remainder of the seal relative to the portion of the seal that connects to the interface frame, including the rim 71. These flexible sections therefore allow for some movement of the mask frame, which can cause the seal to lose contact with the face and allow air to leak. This is because lateral forces on the mask, such as when a wearer sleeps on their side with one side of their face against a pillow, can tend to push the frame sideways without much tendency to move the seal itself, particularly the face-contacting side of the seal, i.e., the wearer's side, sideways.

[0082] In the illustrated embodiment, the more flexible portion includes inwardly directed pleats 101 / 102 on the sidewall of the outwardly facing side of the seal, directed toward the interior of the seal. The pleats have thinner wall sections on either side of the pleats than the outwardly facing side of the seal. In the embodiment of Figures 21 and 22, the inwardly directed pleats 101a and 101b extend partially across the width of the hollow interior of the seal. In the embodiment of Figures 23 and 24, the inwardly directed pleats 102a and 102b extend partially to the depth of the hollow interior of the seal. The embodiments of Figures 21-24 are otherwise identical to the embodiments of Figures 2-17.

[0083] summary The seal of the present invention includes left and right less flexible stabilizing outer sections adapted to contact the face adjacent the lower lateral sides of the nostrils on the left and right sides of the nose when worn. The seal has enhanced stability against rotation on the face, particularly about the seal's width axis, due to, for example, the drag force of the tubing. This rotation can rupture the seal and cause leakage. This is true even in the preferred embodiment of the interface including a seal and side arms as described above, even though the seal does not seal against the delicate bridge of the nose or extend, at least significantly, for example, more than about 1 cm across any flat portion of the nasal ridge cartilage between the bridge and tip of the nose. The left and right sidewall sections of the flexible center on the wearer's side, or at least the upper sections of the left and right sidewall sections, have an outwardly protruding or convex shape on the opposite side of the seal (away from the interior of the seal). These outwardly protruding or convex upper sections on the opposite side of the seal contact the creases and depressions at the junction between the bottom of the sides of the nose and the face and help prevent upward leakage of air pressure in this area toward the eyes. Under the pressure of gas within the seals, they deform (push) outward on the face in this area, enhancing the seal. The preformed or prestructured, yet still flexible and conforming, shape of the inventive seals results in a seal that naturally conforms or conforms to many wearers with only relatively little shape change or deformation, and the positive pressure of the internal gas flow can enhance the seal. Similarly, an effective seal with minimal or no leakage can be achieved for many wearers in small or low-profile masks without requiring the mask to include traditional direct nasal interface pillows or the like that protrude into the wearer's nares. An effective seal can be achieved with a relatively low gas flow rate through the mask, resulting in a relatively low internal pressure of gas within the seal against the nose. Also, in at least preferred embodiments, the seal maintains its shape or structure even when not worn or under internal gas pressure, which can make it more intuitive for the user as to how to place or position the mask on their face.

[0084] Other headgear 25-29 illustrate headgear configurations that are placed behind the head and partially or completely over the ears, thereby providing a favorable force vector for patient interfaces and respiratory masks, such as obstructive sleep apnea (OSA) masks. See, e.g., FIG. 25.

[0085] The headgear 200 may comprise a lightweight stretch fabric, such as Lycra or a similar material, which provides more substantial fabric support. See, for example, FIG.

[0086] In some configurations, the ear-covering sections 210 can be made of a very fine, lightweight stretch fabric to maximize comfort for the wearer. In some such configurations, a more substantial fabric 220 (which may be heavier and / or less stretchy) may be used to construct some or all of the remainder of the headgear. See, e.g., FIG. 26.

[0087] Lamination of fabrics 211 and 212 with different properties or characteristics (e.g., different stretch levels) in some areas can provide additional structure for stability and ease of fitting. See, for example, FIG. 26.

[0088] In one or more embodiments, there are wider attachment points 230 on the front (e.g., wider than comparable conventional mask / headgear) to hold the mask seal stable and reduce or prevent it from swinging around on the face. The attachment points 230 may be as wide as a significant or substantial portion of the height of the mask seal 280. See, e.g., FIG. 25.

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

[0090] In some configurations, the more substantial fabric may extend beyond the front of the ears to provide more structure to the headgear and prevent bunching over the ears. See, e.g., FIG. 26.

[0091] In some configurations, the headgear 200 (or the main body of the headgear) may be constructed solely of lightweight stretch fabric that is wider in region 250 towards the back of the head. See, for example, FIG.

[0092] In some configurations, the headgear 200 may be constructed of a lightweight stretch fabric that widens towards the back of the head and includes a section of more substantial material around the rear 250 to provide structure. See, for example, FIG. 27.

[0093] In some configurations, the headgear may be adjustable at the top of the hoop 260. See, for example, FIG.

[0094] In some configurations, the headgear 200 may have thermoformed sections that hold the ear coverings 270 a desired distance away from the ears, which may be a relatively short distance in some embodiments. See, for example, FIG. 29.

[0095] In some such configurations, the headgear 200 may include curved plastic pieces 270 that are placed a desired distance away from the ears to allow the headgear to slide over the ears more easily. See, for example, FIG. 29.

[0096] Figures 30-36 show an elastic headgear arrangement 300 that uses the chin and crown of the head as anchoring points.

[0097] In some configurations, the main structure 300 is constructed with elastic straps, preferably circular knit, that widen around the chin 310 and back of the head 320. The wide sections may be constructed of a stretch fabric, such as Lycra or similar fabric. See, for example, Figures 30 and 31.

[0098] In some configurations, there may be an adjustment point 330 that rests on the ear. See, for example, Figures 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 aiding 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 may also be adjustable to improve customization of the fit. See, for example, Figures 30 and 31.

[0101] On each side there can be a single or multiple mask attachment straps 340. Figure 32 shows the single strap option.

[0102] In some configurations, the headgear 300 can be tightened so that it acts as a chin strap, thereby assisting mouth breathers. See, for example, FIG.

[0103] The headgear 300 is secured around the head and preferably does not rely on the mask seal 381 as a fastening point. That is, the headgear 300 can remain in place even without the seal 381 attached. Advantageously, such an arrangement isolates the forces of the seal from the forces holding the headgear 300 in place. This arrangement represents an advantageous difference compared to conventional headgear.

[0104] Such a configuration works 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 strap 320 at the rear may split. In some such arrangements, the split portion of the strap 320 may include a rigid component 350. See, for example, FIG. 34.

[0106] In some configurations, the mask attachment straps 340 may include loops 341 that mount to one or more hooks 342 or other retention structures on each side of the mask frame 382. See, for example, Figures 35 and 36.

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

[0108] In some configurations, a rigid or flexible plastic strap 420 terminates above the ear at an attachment point 430 to an elastic strap. See, for example, Figures 37 and 46.

[0109] The rigid or flexible plastic straps 420 may be permanently attached by sewing, welding, riveting, crimping, clipping, or the like, or a combination of these methods. In one preferred configuration, the rigid or flexible plastic straps 420 are attached by sewing. See, e.g., Figures 39-41 and 46.

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

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

[0112] The strap 410 may be left unattached through loop holes 431-433 at the attachment points to allow for adjustability. See, for example, Figures 42 and 43.

[0113] The rigid or flexible plastic strap 420 may be covered with fabric or foam 440 or the like. See, for example, Figures 45 and 47.

[0114] The plastic part 420 may be formed by stamping, injection molding, etc. In one preferred embodiment, the plastic part or strap 420 is formed by injection molding.

[0115] The plastic part 420 may be textured to be pleasant / soft to the touch.

[0116] In one configuration, the elastic straps 410, which are preferably circular knit, may all be the same width or diameter, or may be wider in multiple sections 411 for comfort. See, for example, FIG. 41.

[0117] In some configurations, the elastic strap 410 may have stretchable regions 412 and non-stretchable regions 413. See, for example, FIG.

[0118] Other seals 48-62 show a nose seal 500 having stabilizing flaps 510 to transfer the load of the sealing surface to the cheeks instead of the lips and bridge of the nose. This allows the seal 500 to be thin (e.g., 0.1 mm to 0.5 mm) and, in some configurations, to expand to conform around the nose and still create a leak-tight, comfortable seal. The silicone seal 500 may have a thicker support section 530 (e.g., a thicker wall or other structure that provides increased stiffness compared to other portions of the seal 520).

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

[0120] The size and shape of the flap 510 may be such that it rests on the side of the nose, preferably in the cheek area. See, for example, FIG.

[0121] Preferably, the stabilizing flaps 510 distribute the seal load force evenly, or more evenly across the face compared to existing nasal masks, so that there is no single point or small area of ​​pressure or load.

[0122] Preferably, the flap 510 is wide enough to minimize upward movement of the seal toward the eye as well as provide lateral stability at the nose. See, eg, FIG.

[0123] In some configurations, the inner seal 520 can rest like a traditional nose seal, covering the bridge of the nose and around the sides of the nose, and over the upper lip. See, for example, FIG.

[0124] The flaps 510, in at least one embodiment, may be integral with and made of the same material as the sealing surface 520. In such an embodiment, each of the flaps 510 has one or more thicker sections 530 for stiffness and thinner sections 540 for flexibility, with a desired or optimum balance of stability and weight.

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

[0126] In some configurations, the flap 510 can be split to better fit the face or to better fit some facial geometries. See, for example, FIG. 61.

[0127] In some configurations, the flap 510 can be hollow to better conform to various facial geometries. See, for example, Figures 57-59.

[0128] In at least one embodiment, the seal 500 can be overmolded with a plastic part 550 having arms 551 that provide additional stiffness to the flap instead of or in addition to using thick wall sections of soft elastomeric material. In such an arrangement, the plastic part 550 can be a reinforcing member. See, e.g., FIG. 61.

[0129] In some configurations, the flap 510 may be separate from the sealing portion 520. The flap 510 may be a different material, such as breathoprene, thermoformed breathoprene or foam, or expanded silicone.

[0130] The seals of Figures 48-62 work well in combination with any two-piece headgear, such as headgear arrangements 200 and 400 described herein with respect to Figures 25-29 and 37-47, respectively.

[0131] 63 shows a flexible mask frame 600 for an OSA mask comprising arms 610 that, when the headgear 630 is tightened, pinch the frame 600 inward against the seal 620. For example, the arms 610 may extend outward (away from the user's face) to attachment portions 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 pinch the seal 620. Such an arrangement helps to hold the seal 620 more snugly against the nose, thereby improving the seal and / or stability.

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

[0133] In some configurations, the wings 710 are shaped to rest on either side at the transition between the nose and cheek for stability, preventing leakage and allowing movement of the seal 700.

[0134] In some configurations, the seal 700 is small enough to expose the tip of the nose, thereby accommodating different sized noses. See, for example, FIG.

[0135] In some configurations, the sealing portion 720 may be relatively thin (such as about 0.1 mm to 0.5 mm), but may provide a thicker structure (e.g., greater stiffness) in the central region 721. See, for example, FIG. 68.

[0136] In some configurations, downward pressure on the lower sealing surface 720 pulls the wings 710 inward in a pinching motion, providing a better seal and a more secure fit. See, e.g., FIG. 73.

[0137] In some configurations, the outer walls of one or more portions of the seal (e.g., wings 710) are substantially thicker than the inner walls 720 to direct inflation inward and compress the inflation portion 720 against the face. See, e.g., FIG. 68.

[0138] In some configurations, there is a single opening 730 for airflow to the nostrils. However, in other configurations, there may be two or more openings 730 for airflow to the nostrils.

[0139] In some configurations, the seal 700 may include a nasal tip portion that is contacted or partially or completely covered by the expanding portion to provide a better seal. See, for example, FIG.

[0140] The nasal seal 700 may be used in combination with a mask frame 740 that is flexible enough to pinch the seal towards the nose for a snuger fit and better sealing. See, for example, Figure 75.

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

[0142] In at least one configuration, the inflatable nose seal 700 has only a pad 750 under the nose, with no wings. See, for example, FIG.

[0143] In some configurations, the nasal seal 700 may have small angled protrusions 760 at the top and / or bottom corners of the seal 700, which may aid in the stability of the seal. See, for example, Figures 79-80.

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

[0145] The above describes the present invention, including preferred forms, and it is intended that alterations and modifications such as will be apparent to those skilled in the art be incorporated within the scope of this specification.

Claims

1. 1. A nose seal for a mask interface, said seal comprising: a wearer-facing side and an outward-facing side opposite the wearer-facing side; The wearer side is a nose rest portion having a concave shape and configured to make sealing contact with the tip of the wearer's nose, the underside of the nose, and the base of the nose, and to make sealing contact with the wearer's upper lip; gas flow apertures positioned below the wearer's nostrils; Including, The outward side surface is an opening configured to allow a flow of gas through the aperture and to the wearer; a first stabilizing portion extending on a first side of the opening; a first plication configured to provide lateral movement of the first stabilizing portion; a second stabilizing portion extending on a second opposite side of the opening; and a second plication configured to provide lateral movement of the second stabilizing portion; Including, the first pleat has a wall section that is thinner than a portion of the first stabilizing portion located closer to the opening than the first pleat and a portion of the first stabilizing portion located closer to the wearer than the first pleat; the second pleat has a wall section that is thinner than a portion of the second stabilizing portion located closer to the opening than the second pleat and a portion of the second stabilizing portion located closer to the wearer than the second pleat; Nose seal.

2. The nasal seal of claim 1 , wherein the first pleats and the second pleats are directed toward an interior of the seal.

3. 3. A nasal seal according to claim 1 or 2, wherein the first and second pleats extend partially to the depth of the hollow interior of the seal.

4. 3. A nasal seal according to claim 1 or 2, wherein the first and second pleats extend partially across the width of the hollow interior of the seal.

5. The nose seal of any one of claims 1 to 4, wherein the nose support portion includes left and right walls that contact the left and right lower sides of the wearer's nose.

6. 6. The nasal seal of claim 5, wherein at least an upper section of the left side wall and an upper section of the right side wall have a convex shape on opposite sides of the seal.

7. 7. The nose seal of claim 6, wherein the nose support portion includes an upper wall portion above the aperture that contacts the tip of the wearer's nose, and a lower wall portion below the aperture and rearward of the upper wall portion that contacts the upper lip below the wearer's nose.

8. The nasal seal of claim 7 , wherein the upper and lower wall portions have distinct curved shapes.

9. A nasal seal according to any one of claims 6 to 8, wherein the convex shape of the upper sections of the left and right walls is above the aperture in the height direction of the seal.

10. A nasal seal according to any preceding claim, wherein the thickness of the wall of the seal decreases from the outside of the seal to the wearer side of the seal.

11. 11. A nasal seal according to any preceding claim, wherein the thickness of the first pleats is less than the thickness of the first stabilising portion and the thickness of the second pleats is less than the thickness of the second stabilising portion.

12. An interface comprising a nose seal according to any one of claims 1 to 11 and a frame configured to attach to the nose seal.

13. 13. The interface of claim 12, wherein the frame includes left and right side arms that extend outward and rearward beyond left and right tips of the seal, the left and right side arms extending upward at an angle selected such that the left and right side arms extend along the left and right cheeks of a wearer, and the left and right side arms connect to headgear to hold the interface to the wearer's face.

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