Patient interface and aspects thereof

Abstract

The present invention relates to patient interfaces and aspects thereof. An inflated patient interface is disclosed having a frame supporting a sealing member. The frame and / or the sealing member is secured to the head of a user with a headgear such as a strap. Various features of the sealing member improve the comfort of the user in the nares of the user and on the facial surface in contact with the sealing member.

Description

[0001] This application is a continuation-in-part of application 201711347794.9, filed December 15, 2017, entitled "Patient Interface and Aspects Thereof."

[0002] Any priority application

[0003] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference in their entirety pursuant to 37 C.F.R. § 1.57. BACKGROUND TECHNICAL FIELD

[0005] The present invention relates generally to interfaces for providing a supply of pressurized gas to a recipient. BACKGROUND

[0007] Respiratory gases can be delivered to a user with a variety of different mask styles and for a variety of different purposes. For example, non-invasive ventilation (NIV) can be used to ventilate a user. In addition, a mask can be used to deliver continuous positive airway pressure (CPAP) or variable airway pressure for the treatment of medical disorders, such as obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or congestive heart failure (CHF).

[0008] These non-invasive ventilation and pressure support therapies generally involve the use of a user interface device, typically a nasal or nasal / oral mask, which sits on the face of the user. A flow of breathing gas can be delivered through the mask from a pressure / flow generating device to the airways of the user.

[0009] Typically, a patient interface device includes a mask frame that supports a sealing member. The sealing member contacts the facial surface of the user, including the areas surrounding the nose, which includes the nose and nares. Because such masks are typically worn for long periods of time, a variety of issues must be taken into account. For example, in providing CPAP to treat OSA, the user typically wears the mask all night while he or she sleeps. One issue in this case is that the mask should be as comfortable as possible. It is also important that the mask provide a sufficient seal against the face of the user without great discomfort. SUMMARY

[0010] It is therefore an object of certain embodiments of the present invention to provide an improved sealing member for use in a mask assembly that overcomes the deficiencies of conventional sealing members.

[0011] In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface that incorporates a seal includes a seal body formed of a soft, flexible material and defining an internal cavity and one or more delivery openings for supplying breathing gas from the internal cavity to a patient. The seal body includes a central portion and a side portion extending from each end of the central portion. The seal body further includes an inner side and an outer side, where the inner side of the central portion is configured to extend across a base of a user's nose, and the inner side of each of the side portions is configured to extend across a side of a nose. The inner side of the seal is soft and configured to conform to surfaces of a user's nose under internal pressure, including conforming to outer surfaces of sides of a nose at the side portions of the seal. Each of the side portions defines a transition portion between the outer side and the inner side, where the outer side of each of the side portions includes a hardened region that is stiffer or much stiffer than the soft inner side, the hardened regions extending to or substantially to the transition regions.

[0012] In some such configurations, the hardened regions are formed by relatively thickened portions of the seal body. The thickened portions can taper in thickness prior to the transition portions. The transition portions can include portions that are thicker than the soft inner side.

[0013] In some such configurations, the hardened regions substantially extend along the entire length of the outer side of the seal body.

[0014] In some such configurations, the transition portions include rounded wall segments.

[0015] In some such configurations, a brace is formed of a relatively rigid material and supports a portion of the seal body. The brace can define at least one grip surface portion extending along the outer side of the seal body. The at least one grip surface portion can include at least a pair of grip surface portions substantially opposite one another.

[0016] In some such configurations, the brace defines a mount for mounting the nasal seal to a frame. The mount can include a first member connectable to a second member, where the first member and the second member capture a portion of the seal body therebetween. The first member can be positioned within a cavity of the seal body and can include a sleeve portion extending outwardly from the cavity. The second member can surround the sleeve portion of the first member.

[0017] In some such configurations, the hardened regions are disposed in distal and lowermost segments of the side portions. The distal and lowermost segments of the side portions can flare outwardly relative to adjacent portions of the seal body.

[0018] In some such configurations, the one or more delivery openings include a first delivery opening and a second delivery opening. The nasal seal can further include a nare locator associated with and forming a portion of each delivery opening, wherein a deflection region is defined within an annular transition portion between each of the nare locators and a surrounding portion of the inner side surface. The deflection region has a lower durometer relative to another region of the annular transition portion that is not within the deflection region.

[0019] In some such configurations, the lower durometer is achieved by the deflection region having a smaller thickness than other regions of the annular transition portion. The deflection regions can be located on the outer side surface of the nare locators. The deflection regions can be limited to less than or equal to half of the annular transition portion.

[0020] In some such configurations, the central portion of the seal body defines a thinned zone that permits an upper portion of the inner side surface of the central portion to move forward as a result of a rolling movement of the seal body.

[0021] In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface that incorporates a seal includes a seal body formed of a soft, flexible material and defining an internal cavity and one or more delivery openings for supplying breathing gas from the internal cavity to a patient. The seal body includes a central portion and a side portion extending from each end of the central portion. The seal body further includes an inner side surface and an outer side surface, wherein the inner side surface of the central portion is configured to extend across a base of a user's nose, and the inner side surface of each of the side portions is configured to extend across a side of a nose. The inner side surface of the seal is soft and configured to conform to surfaces of a user's nose under internal pressure, including conforming to outer surfaces of sides of a nose at the side portions of the seal. The outer side surface of each of the side portions includes hardened regions that are harder or much harder than the soft inner side surface, the hardened regions being disposed in distal and lowermost sections of the side portions.

[0022] In some such configurations, the distal and lowermost sections of the side portions flare outward relative to adjacent portions of the seal body.

[0023] In some such configurations, the flared side portions generally align with surfaces of laterally outward cheek or upper lip of a user's nose.

[0024] In some such configurations, the hardened regions are formed by relatively thickened portions of the seal body.

[0025] In some such configurations, the thickened portions taper in thickness prior to a transition portion between the inner side surface and the outer side surface.

[0026] In some such configurations, the transition portions comprise portions that are thicker than the soft inner side.

[0027] In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface that incorporates a seal comprises a seal body formed of a soft, flexible material and defining an internal cavity and one or more delivery openings for supplying breathing gas from the internal cavity to a patient. The seal body comprises a central portion and a side portion extending from each end of the central portion. The seal body further comprises an inner side and an outer side. The inner side of the central portion is configured to extend across a base of a user's nose, and the inner side of each of the side portions is configured to extend across a side of a nose. The inner side of the seal is soft and configured to conform to surfaces of a user's nose under internal pressure, including conforming to outer surfaces of sides of a nose at the side portions of the seal. The outer side of each of the side portions comprises a hardened region that is stiffer or much stiffer than the soft inner side. The outer side of the seal body further defines a grip surface on each of the side portions, the grip surface being located on the hardened region.

[0028] In some such configurations, the grip surfaces are formed by protrusions.

[0029] In some such configurations, the protrusions are generally crescent shaped, defining a generally scallop-shaped grip surface.

[0030] In some such configurations, the end of the protrusion is positioned at a rear of the central, curved portion of the protrusion.

[0031] In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface that incorporates a seal comprises a seal body formed of a soft, flexible material and defining an internal cavity and one or more delivery openings for supplying breathing gas from the internal cavity to a patient. The seal body comprises a central portion and a side portion extending from each end of the central portion. The seal body further comprises an inner side and an outer side. The inner side of the central portion is configured to extend across a base of a user's nose, and the inner side of each of the side portions is configured to extend across a side of a nose. The inner side of the seal is soft and configured to conform to surfaces of a user's nose under internal pressure, including conforming to outer surfaces of sides of a nose at the side portions of the seal. The nasal seal further comprises a brace formed of a relatively rigid material and supporting a portion of the seal body. The brace defines at least one grip surface portion extending along the outer side of the seal body.

[0032] In some such configurations, the cradle defines at least one grip surface portion extending along an outer side of the seal body.

[0033] In some such configurations, the at least one grip surface portion comprises at least one pair of grip surface portions substantially opposite one another.

[0034] In some such configurations, the cradle defines a mount for mounting the nasal seal to the frame.

[0035] In some such configurations, the mount comprises a first member connectable to a second member, wherein the first member and the second member capture a portion of the seal body therebetween.

[0036] In some such configurations, the first member is positioned within a cavity of the seal body and comprises a sleeve portion extending outwardly from the cavity.

[0037] In some such configurations, the second member surrounds the sleeve portion of the first member.

[0038] In some configurations, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface incorporating a seal includes a seal body formed of a soft, flexible material and defining an internal cavity. The seal body includes a central portion and a side portion extending from each end of the central portion. The seal body further includes an inner side and an outer side. The inner side of the central portion is configured to extend across a base of a user's nose, and the inner side of each of the side portions is configured to extend across a side of the nose. The inner side of the seal is soft and configured to conform to surfaces of the user's nose under internal pressure, including conforming to outer surfaces of the sides of the nose at the side portions of the seal. The seal body includes a first delivery opening and a second delivery opening for supplying breathing gas from the internal cavity to a nare of the user. A nare locator is associated with and forms a portion of each delivery opening. A deflection region is defined within a transition portion between each of the nare locators and a surrounding portion of the inner side. The deflection region has a lower durometer relative to another region of the transition portion that is not within the deflection region.

[0039] In some configurations, the deflection regions have a lower thickness than other regions of the transition portion.

[0040] In some configurations, the deflection regions are located on an outer side of the nare locators to facilitate movement of the nare locators outwardly away from one another.

[0041] In some configurations, the deflection regions are limited to less than or equal to half of the transition portion, and the deflection regions can be generally annular in shape.

[0042] In some configurations, a patient interface or a sealing arrangement for a patient interface includes a first delivery opening for supplying respiratory gases from an internal lumen to a user's nares and a second delivery opening. A nare locator or sealing member (e.g., a nasal pillow) is associated with and forms a portion of each delivery opening. A deflection region is defined within an annular transition portion between each nare locator or sealing member and a surrounding portion of the sealing arrangement. The deflection region has a lower durometer relative to another region of the transition portion that is not within the deflection region. The lower durometer can be achieved by a lower wall thickness within the deflection region compared to other regions. The deflection region can be located externally of the nare locator or sealing member to facilitate tilting outwardly. The deflection region can be limited to less than or equal to about one-half of the annular transition portion, and the deflection region can be generally annular in shape.

[0043] In some configurations, a sealing member is provided for a mask, where the sealing member has any set or subset of the features described herein or any combination of sets or subsets of the features. In some such configurations, a mask can have such a sealing member.

[0044] In some configurations, a sealing member includes a proximal surface and a distal surface. The proximal surface has one or more delivery openings for supplying respiratory gases to a patient. The proximal surface and the distal surface define an internal lumen within the sealing member. At least one integrated support structure is located beneath at least a portion of the internal lumen.

[0045] In some such configurations, the at least one integrated support structure includes a crescent-shaped member that is structurally integrated into the sealing member.

[0046] In some such configurations, the at least one integrated support structure extends at least partially upward along at least a portion of the distal surface. In some such configurations, the at least one integrated support structure extends upward along the distal surface. In some such configurations, a portion of the at least one integrated support structure that extends upward along the distal surface extends proximally and is configured to provide support relative to a region of a user's cheek region.

[0047] In some such configurations, the portion of the integrated support structure that is beneath the internal lumen extends proximally and is configured to provide support relative to a region of a user just above the lips.

[0048] In some such configurations, the integrated support structure includes one or more thickened regions of the sealing member. In some such configurations, the thickened regions incorporate a hollow region having another material positioned within the hollow region of the integrated support structure.

[0049] In some such configurations, the at least one integrated support structure is positioned in an edge surface that connects the proximal surface to the distal surface. In some such configurations, the edge surface is wider at a bottom portion than at a top portion. In some such configurations, the sealing member has a thicker wall in a region that includes the bottom portion of the edge surface relative to a region that generally surrounds the one or more delivery openings. In some such configurations, the region with the thicker wall extends upward from the bottom portion of the edge surface.

[0050] In some such configurations, the at least one integrated support structure is positioned in a widest lateral region of the sealing member.

[0051] In some such configurations, the at least one integrated support structure extends proximally of any other portion of the sealing member.

[0052] In some such configurations, the at least one integrated support structure is positioned in a widest lateral region of the sealing member and extends proximally of any other portion of the sealing member.

[0053] The various features, aspects, and advantages of the present application can be realized in any of several manners. For example, although several embodiments will be described herein, a set or subset of features from any embodiment can be used with a set or subset of features from any other embodiment.

[0054] The term "comprising" is used herein to mean "including at least" when referring to a set of elements of a process, method, or apparatus. When used in the context of a process, method, or apparatus, the term "comprising" means that the process, method, or apparatus includes at least the recited elements, but that it is not necessarily limited to those elements. The relevant

[0055] In this specification, where a patent specification, other external document, or other source of information is referred to, this is generally for the purpose of providing context. Unless specifically stated otherwise, reference to such external documents is not to be construed as an admission that such documents, or such source of information, forms part of the common general knowledge in any jurisdiction or that they are prior art in any jurisdiction. BRIEF DESCRIPTION OF DRAWINGS

[0056] These and other features, aspects, and advantages of the present application will be described in connection with the following drawings.

[0057] Figure 1 is a front view of an interface assembly arranged and configured in accordance with certain features, aspects, and advantages of the present application.

[0058] Figure 2 is a side view of the interface assembly of Figure 1

[0059] Figure 3 is a rear view of the interface assembly of Figure 1

[0060] Figure 4 is a schematic view of a user wearing an interface assembly having certain features in common with the interface assembly of Figure 1

[0061] Figure 5 is a partially exploded view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0062] Figure 6 is a view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0063] Figure 7 is a view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0064] Figure 8 is a view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0065] Figures 9A-9F is a view of a plurality of portions of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0066] Figure 10 is a view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0067] Figure 11 is a view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0068] Figure 12 is a view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0069] Figure 13 is a view of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0070] Figures 14A-14D is a view of a plurality of portions of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0071] Figures 15A-15D ​​​Figures are views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0072] Figure 16 Figures are rear views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0073] Figure 17 Figures are bottom views of a portion of an interface assembly. Figure 16 Figures are bottom views of a portion of an interface assembly.

[0074] Figure 18 Figures are perspective views of a portion of an interface assembly. Figure 16 Figures are perspective views of a portion of an interface assembly.

[0075] Figure 19 Figures are views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0076] Figures 20A-20E Figures are views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0077] Figure 21 Figures are views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0078] Figure 22 Figures are views of a portion of a nasal cavity and an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0079] Figures 23A-23C Figures are views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0080] Figure 24 Figures are views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0081] Figure 25A Figures are views of a portion of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application. Figure 25B Figures are views of a previous interface assembly and an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0082] Figure 26 Figures are views of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0083] Figure 27 Figures are views of another interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0084] Figure 28is a view of another interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0085] Figure 29 is a partially exploded perspective view of an interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application.

[0086] Figure 30 is a more complete exploded perspective view of the interface assembly of Figure 29

[0087] Figure 31 is a perspective view of the interface assembly of Figure 29

[0088] Figure 32 is a cross-sectional view taken along line 32-32 in Figure 31

[0089] Figure 33 is a cross-sectional view taken along line 33-33 in Figure 31

[0090] Figure 34 is a magnified view of a portion of the sealing member of Figure 33

[0091] Figures 35-37 is a view of the sealing member of the interface assembly of Figure 29

[0092] Figures 38-40 is a view of the sealing member, showing the material thickness of the distal wall.

[0093] Figure 41 is a magnified view of a portion of the section of the sealing member shown in Figure 33

[0094] Figure 42 is a rear view of the sealing member of the interface assembly of Figure 29

[0095] Figure 43 is a cross-sectional view of another interface assembly arranged and constructed in accordance with certain features, aspects and advantages of the present application. DETAILED DESCRIPTION

[0096] Figure 1 A patient interface 100 arranged and constructed in accordance with certain features, aspects and advantages of the present application is shown. The interface 100 can be used to supply pressurized breathing gas to a recipient. The interface 100 is well suited for use in providing breathing gas to a recipient in situations where significant pressure variations are likely to be encountered. For example, but not by way of limitation, the interface 100 can be used for delivery of continuous positive airway pressure (CPAP).​​​​​​​​

[0097] With continued reference to Figure 1 the interface 100 is shown separated from a patient who will wear the interface 100. Some aspects of the patient interface 100 and variations of the various aspects have been described in U.S. Patent Application No. 12 / 945,141, filed November 12, 2010, which is incorporated herein by reference in its entirety. The interface 100 generally includes a mask 102. In some configurations, a strap 104 can be attached to the mask 102 and can be used to secure the mask 102 to the patient. In some configurations, the interface 100 also includes a flexible supply conduit 106 that can be connected to the mask 102.

[0098] With continued reference to Figure 1 and with additional reference to Figure 2 the mask 102 is configured to fit over or cover both nares of a patient. In some configurations, the mask 102 can include side portions 110 (see FIG. 2) that are configured to curve around each side of the patient's nose. The side portions 110 can form a perimeter seal on the outward facing surface of the sides of the nose. The strap 104 can wrap around the head of the user in a simple loop over the ears of the user. Figure 2

[0099] The flexible conduit 106 can drape from a center connector 112. In some configurations, the center connector 112 can be positioned at a front portion of the mask 102. The center connector 112 preferably includes a swivel elbow. The elbow can enable the flexible conduit 106 to pivot relative to the mask 102. By enabling the flexible conduit to pivot, the elbow can help the interface 100 better accommodate the sleeping position of the patient. In some configurations, the center connector 112 can include a ball joint such that the elbow can pivot about axes parallel and perpendicular to its connection with the mask 102.

[0100] The illustrated mask 102 generally includes a seal 114 and a body or frame 116. The seal 114 and the frame 116 can be connected in any suitable manner.

[0101] ​The seal 114 preferably defines a soft pocket or envelope that can include recessed areas. In some configurations, the seal 114 can include a low wall thickness and can be formed from any suitable material. For example, but not by way of limitation, the seal 114 can be formed from latex, vinyl, silicone, or polyurethane. In some configurations, the wall thickness can be less than about 0.5 mm and in some areas and in some configurations can be less than about 0.2 mm. In some configurations, the seal 114 can be formed from a material that has sufficient elasticity and yield strength such that the combination makes the seal 114 soft. The seal 114 is preferably capable of withstanding repeated severe deformation without damage.

[0102] With reference to Figure 3 the seal 114 preferably includes one or two nare locators 120. The nare locators 120 can project from the seal 114. In some configurations, the nare locators extend generally upwardly and rearwardly from a proximal wall 124 of the seal 114. In some configurations, the nare locators 120 extend generally rearwardly from the proximal wall 124 of the seal 114.

[0103] In the configuration shown in Figure 1-3 the nare locators 120 are integrally formed with the seal 114 (i.e., in one monolithic piece). Each nare locator 120 can include an exit hole 118 through which gas can be supplied from the flexible conduit 106. In some configurations, gas can be supplied from within a pocket or envelope defined by the seal 114. In other configurations, the supplied gas can be separate from the gas supplied to the pocket or envelope defined by the seal 114.

[0104] The seal 114 generally includes a distal wall 122 and a proximal wall 124. An outer surface of the distal wall 122 preferably faces away from the user, while an outer surface of the proximal wall 124 preferably faces the user. A rim 126 (see Figure 1 and 2 ) can connect an outer periphery of the distal wall 122 and an outer periphery of the proximal wall 124. The aforementioned envelope or pocket can be defined within at least the distal wall 122 and the proximal wall 124.

[0105] The seal 114 is preferably designed to wrap around the tip or lower portion (e.g., a position below the bridge of the nose) of the user's nose. As such, the illustrated seal 114 includes a central portion 128 (see Figure 1The central portion 128 can be located below the user's nose and preferably incorporates the nare locators 120. In some configurations, the central portion 128 can extend upward beyond the tip of the user's nose. In other configurations, the central portion 128 does not extend upward beyond the tip of the user's nose. The wings 130 can form at least a portion of the side portions 110 described above. The wings 130 can be configured to extend completely or substantially completely beyond the sides of the user's nose and can extend at least partially beyond the user's cheeks.

[0106] As described above, at least a substantial portion of the seal 114 can be soft. For example, the area surrounding the nare locators 120 can be softer than at least a portion of the wings 130. The proximal walls 124 and the rims 126 of at least each side portion can be very soft such that they can expand to conform to the contours of the user's face and, in particular, the contours of the lateral sides of the user's nose. Preferably, the soft portions of the seal 114 are of sufficient size and shape such that when the inflated seal is pressed against the user's face with the nare locators 120 engaged into the user's nare, the seal 114 conforms to the surfaces of the user's face (i.e., at least the sides of the nose and along at least a portion of the upper lip).

[0107] However, selected portions of the seal 114 can have increased rigidity to improve the fit, comfort, and function of the mask 102. For example, at least a portion of the rims 126 can be substantially stiffer to provide control over the expansion of other areas of the seal 114. In addition, the area adjacent to the seal 114 and including the air inlet (e.g., the portion receiving the flow of gas from the conduit 106) can be less soft. Thus, the distal walls 122 can have a decreasing softness from the wings 130 to the central portion containing the air inlet. The less soft areas can be formed of different materials or can be formed of the same material but with increased thickness.

[0108] As described above, the frame 116 supports the seal 114. In some configurations, the air inlet of the seal 114 can be fitted to the frame 116 and the flexible conduit 106 can also be fitted to the frame 116 such that gas can be provided to the seal 114 through the frame 116. In other configurations, the seal 114 is directly connected to the flexible conduit 106. In some configurations, the seal 114 can be connected to the conduit 106 with the central connector 112.

[0109] The frame 116 can have any suitable arrangement for securing the seal 114. In some configurations, an annular wall can extend from the proximal side of the frame 116 around the perimeter of the opening to the connector 112. The annular wall can include an outwardly extending lip. The inlet of the seal 114 can be engaged over the outwardly extending lip of the annular wall. In some configurations, the inlet of the seal 114 can be stretched to fit over the annular wall. For example, but not by way of limitation, the inlet of the seal 114 can be provided with a thickened or stiffened wall section. In some configurations, the extended portion of the seal 114 can be rolled over the annular wall of the frame 116. In another configuration, the seal 114 can be provided with a portion of the connector and at least one of the frame 116, and the conduit 106 can include a complementary connector portion.

[0110] The frame 116 can be designed to be as minimal in size as possible. Advantageously, a small frame 116 allows the user to have an unobstructed view and permits the user to wear eyeglasses while wearing the interface 100. Preferably, the frame 116 is formed of an elastomeric material, which will allow the frame 116 to flex to slightly conform to the user's face. However, the frame 116 provides support for the seal 114. By providing support for the seal 114, the seal can be more effectively pressed into contact with the face and around the user's nose. For example, but not by way of limitation, the frame 116 can be formed by injection molding, preferably of an elastomeric material such as silicone or polyurethane. For example, but not by way of limitation, in some configurations, the frame 116 can be formed of a more rigid material such as polycarbonate, polyester, polystyrene, or nylon.

[0111] In use, the soft proximal walls 124 on either side of the nares positioners 120 can be inflated by the pressure inside the seal 114 (e.g., by the flow of gas supplied to the patient interface 100) to press against the user's skin and conform to the contours of the outer surface of the user's nose, to the surface of the lower portion of the user's nose, and to the surface of the user's upper lip just below the nose. Movement of the mask 102 is unlikely to greatly disrupt this seal to the face, as the soft perimeter or periphery of the seal 114 allows the mask 102 to move at least a small range in all directions (except directly away from the face). The soft portions of the seal 114 decouple the position of the nares positioners 120 from the position of the mask 102 to some extent, which allows the mask 102 to shift to some extent in at least one or both of the lateral or vertical directions (i.e., lateral and vertical relative to the axis of the patient's face). The wings 130 engage the sides of the user's nose and form additional seals. The wings 130 also support the position of the mask.

[0112] Referring to Figure 4 When donning interface 100, face mask 102 can be opened by spreading apart wings 130, which increases the angle between wings 130. With wings 130 already pulled apart, nare locators 120 (see Figure 3 ) positioned on proximal walls 124 are better presented to the user and guide positioning of face mask 102 onto the user's face. With nare locators 120 properly positioned, face mask 102 can be secured in place by straps 104, forming a loop around the user's head at a vertical height above the ears. Other techniques for donning an interface can also be used.

[0113] As noted above, when donning interface 100, seal 114 is preferably folded or stretched open to improve fit and help achieve desired positioning. However, in the configuration of Figure 1-4 , stretching open seal 114 typically requires a hand to be positioned between seal 114 and the user's face, which can be awkward for the user. Additionally, with a single hand used to open seal 114, it can be difficult for the other hand to be used to place straps 104 in proper position.

[0114] Referring to Figure 5 , an interface 100a is shown having a seal manipulation assembly 140. For clarity, seal 114a of interface 100a is shown enlarged and connected to frame 116a in an upper portion of Figure 5 , and frame 116a is not present in a lower portion of Figure 5 . Seal manipulation assembly 140 preferably includes a pair of pads 142. Pads 142 extend outwardly from seal 114a. In some configurations, pads 142 are positioned along distal surface 122a. In some configurations, pads 142 extend outwardly from distal surface 122a. In some configurations, pads 142 are integrally formed with seal 114a. In some configurations, pads 142 are separate components from seal 114a. In the illustrated configuration, frame 116a of interface 100a includes recesses 144 that receive at least a portion of pads 142. Seal 114a is positioned under frame 116a in the area of pads 142. In some configurations, seal 114a is not secured to frame 116a in the area of pads 142 or proximate to the area, such that seal 114a is movable relative to frame 116a.

[0115] The gasket 142 is connected to an operating mechanism of the seal manipulation assembly 140. In some configurations, the gasket 142 is connected to scissor arms that extend within the seal 114a. The scissor arms can pass through and be connected with a hinge, such that pushing of the gasket 142 toward one another can cause the ends 146 of the seal 114a to move away from one another.

[0116] In some configurations, the operating mechanism is simpler than the scissor mechanism directly described above. For example, referring to Figure 6 (the figure is a simplified representation of the operating mechanism), the gasket 142 is connected to or formed integrally with the arms 150. The arms can extend toward the ends 146 of the seal 114a. The arms 150 can have a length that is longer than the length of the gasket 142. A cross member 152 can be used to keep the front portions of the arms 150 apart from one another. In some configurations, the material of the seal 114a, the frame 116a, or the combined seal 114a and frame 116a can be hard enough to allow the ends 146 of the seal 114a to be separated or spread apart by manipulating the gasket 142 that does not include the cross member 152. By keeping the arms 150 apart at a location between the gasket 142 and the ends 146, pressing the gasket 142 toward one another will cause the ends 146 to move away from one another. In some configurations, the arms 150 can be joined together by a living hinge, by a rigid connection to a flexibly cross member that elastically deforms, or by pin engagement, among other possibilities.

[0117] By manipulating the shape of the un-inflated seal 114a (e.g., by separating the ends 146 to alter how the seal 114a presents itself to the user originally), the seal 114a is opened for placement onto the face of the user. When in place, the seal 114a can be inflated, which causes the seal 114a to expand around the nostrils of the user.

[0118] Referring now to Figure 7 , another seal 114b is shown. The seal 114b has been equipped with another seal manipulation configuration 140b. In the seal 114b shown, the seal manipulation configuration 140b can be attached to or formed integrally with a portion of the distal wall 122b. Preferably, the seal manipulation configuration 140b is positioned along the distal wall 122b, along the side portion 110b, or the wing 130b.

[0119] The seal manipulation configuration 140b can take any suitable configuration. In some configurations, for example but not by way of limitation, the seal manipulation configuration 140b includes walls 154 that can define a loop of material into which a finger can be inserted. In the illustrated configuration, the seal manipulation configuration 140b includes pockets 156. Each of the pockets 156 can have a rim 160 at a distal end. The rim 160 can define an opening that is large enough to receive a fingertip. The proximal end of each of the pockets 156 can be closed or open. In the illustrated configuration, the proximal end of each of the pockets 156 is closed.

[0120] In some configurations, a surface feature 158 can be provided adjacent to the opening defined by the rim 160. The surface feature 158 can be a recess or a surface structure. The surface feature 158 can be positioned just forward of the opening to guide a finger into the desired position. The surface feature 158 can provide additional clearance to facilitate insertion of a finger.

[0121] By positioning the pockets 156 on the outside of the seal 114b, a finger can be inserted into the pocket 156 and the pocket 156 can be used to provide an outward force on the flap 130b to open the seal 114b for presentation to the face.

[0122] Reference is now made to Figure 8 The mask 102c can have a seal 114c featuring integrated arms 170. In the illustrated configuration, the arms 170 can extend along the exterior portion of the distal arm 122c. In cases where the arms 170 are integrated into the seal 114c, the frame 116 can be omitted, integrated directly into the seal 114c or remain a separate support element. When the mask frame is integrated into the seal 114c, the mask frame 116 features can be replaced with regions having increased thickness or overmolded features. For example, when the mask frame is integrated into the seal 114c, the mask frame 116 features can be replaced with regions having increased thickness or overmolded features.

[0123] In the illustrated configuration, the integrated arms 170 extend proximally from the distal region of the distal arm 122c. Preferably, each end portion 146c is separated from the associated arm 170 so that the end portion 146c can move without significant movement of the overlying portion of the arm 170. In other words, the connection between the arm 170 and the distal wall 122c can terminate distally of the end portion 146c so that at least a portion of the arm 170 overlies, but is not directly connected to, the proximal end of the distally facing wall 122c.

[0124] In the illustrated configuration, an attachment member 172 can be formed at the proximal end of each arm 170. This attachment member 172 can have any suitable configuration and can be used to connect the arms 170 to a strap (not shown) or other headgear component. In the illustrated configuration, the attachment member 172 includes a strut 174 positioned within a recess 175. For example, but not by way of limitation, a strap or other headgear can be looped around the strut 174 or secured to the strut 174 with a hook member.

[0125] Figures 9A-9F A seal 114d is shown having a distinct surface structure along at least a portion of the proximal wall 124d. The surface structure can be positioned along any portion of at least the proximal wall 124d. In some configurations, the surface structure can be positioned along a proximal portion of the proximal wall 124d. In some configurations, the surface structure is positioned only along a proximal portion of the proximal wall. In some configurations, the surface structure can be positioned on other surfaces, but relative to the proximal wall 124d, the surface structure is positioned only proximal to the nostril locator 120d.

[0126] Figures 9A-9F The following surface structures are shown: slots 176, recesses 180, scallops 182, lands 184, and ribs 186. Any other suitable surface structure, including shapes, recesses, and protrusions, can be provided to the proximal wall 124d of the seal 114d. In some configurations, a combination of surface structures can be used, including, but not limited to, those described herein.

[0127] In some configurations, the textured portion is positioned lateral to the nostril locator 120d. In some configurations, the textured portion is positioned completely lateral to the nostril locator 120d. In some configurations, the textured portion can be positioned around, generally around, or generally adjacent to the nostril locator 120d. In these positions, the textured portion can reduce the contact surface area with the user's skin while still maintaining a sufficient seal against the user's face. By reducing the contact surface area between the user's face and the seal 114d, the contact area is perceived as cooler by the user. Because, in some configurations, other areas beside the areas having textured surfaces define the primary seal with the face, these textured surfaces can improve comfort without greatly degrading the seal that exists between the seal 114d and the face.

[0128] Figure 1-4 The interface shown in FIG. 1 is an architecture that integrates both the seal 114 and the nostril locator 120 into a single component. Referring now to FIG. 2, an alternative interface is shown in which the seal 114 and the nostril locator 120 are separate components. In this configuration, the seal 114 is attached to the nostril locator 120 with a strap 130. The strap 130 can be any suitable material and can be any suitable configuration. In some configurations, the strap 130 can be a single piece of material. In some configurations, the strap 130 can be a plurality of pieces of material that are attached to one another. In some configurations, the strap 130 can be a single piece of material that is attached to the seal 114 and the nostril locator 120. In some configurations, the strap 130 can be a plurality of pieces of material that are attached to one another and to the seal 114 and the nostril locator 120. Figure 10-12The interface can also include a mask having separable nare locators and a seal. By providing separability between the seal and one or more of the nare locators, the mask can better fit for use by users having different facial geometries. For example, different separable components can have different sizes. In some configurations, the inflatable seal can be universal, while the nare locators can be swapped depending on the size desired by the user. In some configurations, the seal can have different geometries, such as, for example and without limitation, a wide version and a narrow version.

[0129] Referring now to Figure 10 , the illustrated interface 100e includes a seal 114e having separable nare inserts 190 and a sealing member 192. While the seal 114e is formed of more than one component, the seal 114e can otherwise be generally configured in the same manner as the seal 114 illustrated in Figure 1-4 and described above. For example, the seal 114e can be configured with softer and less soft regions similar to the seals disclosed above.

[0130] The nare inserts 190 include at least one nare locator 194. The nare locators 194 can be located atop a body 196. In the illustrated configuration, the two nare locators 194 are integrally formed with the body 196. In some configurations, the two nare locators 194 can be separate from the body 196.

[0131] The body 196 includes a plug portion 200 and the sealing member 192 includes a socket portion 202. The plug portion 200 can be received within the socket portion 202 as indicated by the arrow in Figure 10 In some configurations, the plug portion 200 is locked into position within the socket portion 202. In some configurations, the plug portion 200 is secured within the socket portion 202 by a friction fit. Other suitable techniques for securing the plug portion 200 and the socket portion 202 can be used.

[0132] A distal end 204 of the body 196 includes an air inlet, and proximal to the air inlet, the body 196 includes one or more openings 206. The air inlet can be connected to the flexible supply conduit 106. The sealing member 192 includes one or more internal voids or openings 208, and the one or more internal voids or openings 208 can be in fluid communication with the one or more openings 206 when the plug portion 200 is positioned within the socket portion 202. Thus, in the configuration of Figure 10 the gases flow from the flexible conduit into the nare inserts 190 and a portion of the gases flow from the nare inserts 190 into the sealing member 192, while a portion of the gases flow through the nare locators 194 from the nare inserts 190 to the user.

[0133] Reference Figure 11 A nasal insert 190a and a sealing member 192a can be combined to define a face mask. The nasal insert 190a may have an inlet at a plug portion 200a, located at the distal end of the nasal insert 190a. This inlet may be formed by the plug portion 200a. However, the sealing member 192a may have a distal inlet (not shown) directly connected to a supply conduit (i.e., connected to a supply conduit rather than receiving flow from the nasal insert 190a) and an outlet connected to the nasal insert 190a. The nasal insert 190a may include, but is not necessarily required to, be used in… Figure 10 The opening in the configuration. Therefore, in Figure 11 In the configuration shown, the gases are first supplied to the sealing member 192a before being delivered from the nasal insert 190a to the nostril locator 194a, and the sealing member 192a delivers the gases to the nasal insert 190a through an inlet at the distal end of the nasal insert 190a.

[0134] Now refer to Figure 12 This section will describe another multi-piece sealing construction. This multi-piece construction allows for customization of the seal to the user. For example, different sized nostril positioners can be used with a universal sealing member or sealing members of different sizes. Additionally, nostril positioners with different hardness or stiffness can be used, and / or sealing members with different levels of hardness can be used. In some configurations, the sealing member and these nostril positioners can be formed from the same material. In some configurations, the sealing member and these nostril positioners can be formed from the same material of different grades.

[0135] Figure 12 The sealing member 192b shown includes one or more vents 208 formed on its proximal surface. In the illustrated configuration, the sealing member 192b includes two openings 208 for receiving individual nostril locators 210. These openings 208 may define a slot, while the distal end 212 of the nostril locator 210 may define a plug. Figure 12 As shown, these distal ends 212 are fitted into the opening 208. The nostril locator 210 can be connected to the sealing member 192b in any suitable manner. In some configurations, the nostril locator 210 may be frictionally fitted into the opening 208. In some configurations, the distal ends 212 and the opening 208 may be configured to be connected in only one rotational orientation. In some configurations, this rotational orientation may be different to customize the fit of the nostril locator 210. In some configurations, this relative rotational orientation between the opening 208 and the nostril locator 210 may be addressable, such that both can be rotationally adjustable and fixed in a desired rotational position.

[0136] Referring now to Figure 13 , a seal 214 is shown featuring a separable nose insert 216 and a sealing member 218. The seal 214 can be similar to any of the configurations described above. In some configurations, however, the nose insert 216 includes an auxiliary component 220. As shown in Figure 13 , the auxiliary component 220 can be positioned between the one or more nare locators 222 and a base 224 of the nose insert 216. In some configurations, a rim 230 can surround the one or more nare locators 222 and the auxiliary component 220 can be positioned between the rim 230 and the base 224. In some configurations, the rim 230 can be positioned between the one or more nare locators 222 and the auxiliary component 220. In the illustrated configuration, the base 224 of the nose insert 216 can include, but need not, one or more openings 226.

[0137] As described above, the sealing member 218 can be flexible. In the illustrated configuration, the sealing member 218 includes an opening 228 that receives at least a portion of the nose insert 216. The opening 228, as well as the auxiliary component 220, is flexible enough so that the auxiliary component 220 of the nose insert 216 can be inserted into a pocket defined within a wall of the sealing member 218. In some configurations, the opening 228 seals around a portion of the nose insert 216 between the auxiliary component 220 and the rim 230.

[0138] For example, but not by way of limitation, the rim 230 and the auxiliary component 220 can be separated by a gap, recess, channel, or groove. The sealing member 218 can include a lip that is received within the gap, recess, channel, or groove, which can be defined between at least a portion of the rim 230 and the auxiliary component 220. In other words, the auxiliary component 220 can be overlaid on at least a portion of the rim 230 and can be separable therefrom. The gap between the auxiliary component 220 and the rim 230 can be sized and configured to receive at least a portion of the seal 214. For example, but not by way of limitation, in this manner, the sealing member 218 and the nose insert 216 can be secured together. Moreover, in the illustrated configuration, the sealing member 218 and the nose insert 216 can be sealed together.

[0139] Referring now to Figures 14A-14D , samples of different configurations of auxiliary components will be described. Figure 14AThe figure shows a nasal insert 216a, in which an auxiliary component 220a includes a slightly curved blade member 232. The blade member 232 extends laterally outward beyond the nostril locator 222a and laterally outward beyond the rim 230a, generally surrounding the outermost portion of the nostril locator 222a. The blade member 232 may be integrally formed with the nasal insert 216a or may be separately formed from the nasal insert 216a and attached to the nasal insert in any suitable manner. In some configurations, the blade member 232 is formed of silicone. The blade member 232 may be a resilient member capable of bending into both a first and a second position. In some configurations, the blade member 232 may be a bidirectionally stable member. In other words, the blade member 232 may assume sufficient stability to be at least temporarily held in two different positions. In some configurations, the blade member 232 has sufficient resilientness to assume a first shape or position when the associated sealing member 218a is underinflated or uninflated. In some configurations, the blade member 232 will bend or deflect when the associated sealing member 218a is inflated for use. Figure 14A This configuration is shown in the figure, in which the outermost part of the blade member 232 has been deflected upward.

[0140] like Figure 14A As shown, the blade member 232 provides additional material to one or more inner surfaces of the contact sealing member. The blade member 232 can be configured to push the sealing member 218a into an open position to assist in the fitting of the mask onto the user's face by deflecting laterally during use. By slightly opening the mask, the nostril locator 222a can be more easily paired with the nostrils. When air pressure is supplied to the sealing member 218a, the sealing member will inflate and expand to seal against the user's face. Preferably, the blade member 232 is flexible enough that it can bend and conform to the shape of the sealing member 218a as it begins to inflate, allowing the sealing member 218a to inflate and seal around the user's nose.

[0141] Figure 14B It shows some aspects and Figure 14A The nasal insert 216a shown is similar to the nasal insert 216b. Figure 14B The rim 230b of the nasal insert 216b includes a ring member 234. This ring member 234 is similar in some respects to the blade member 232; however, the ring member 234 extends both proximally and distally, and also laterally outwards. In other words, as... Figure 14A and Figure 14B A comparison clearly shows that, although the blade component 232 is... Figure 14AThe ring member 234 is generally a less flattened and longitudinally extending member. As such, the ring member 234 facilitates manipulation of not only the proximal portion of the associated sealing member 218b, but also the distal portion of the sealing member 218b. In other words, given that the blade member 232 contacts the inner surface on the distal portion of the sealing member, the ring member 234 can contact the inner surfaces on both the proximal and distal portions of the sealing member 218b.

[0142] With continued reference to Figure 14B The ring member 234 extends laterally outward from the nare positioner 222b and outward beyond the outermost extent of the rim 230b. The ring member 234 can be integrally formed with the nasal insert 216b or can be separately formed from the nasal insert 216b and secured thereto in any suitable manner. In some configurations, the ring member 234 can be formed from silicone.

[0143] By contacting the inner surfaces of the sealing member 218b, the ring member 234 places the sealing member 218b in an open position prior to inflation and provides an initial shape to the deflated sealing member 218b. When air pressure is supplied to the sealing member 218b, the sealing member 218b will inflate and expand into sealing engagement with the user's face. Preferably, the ring member 234 is sufficiently flexible so that as the sealing member 218b begins to inflate, the ring member 234 can flex and conform to the shape of the sealing member 218b so that the sealing member 218b can inflate and seal around the user's nose. In some configurations, the ring member 234 can be switchable between two positions. In some configurations, the ring member 234 can be configured to only deflect out of the open position or first position when the seal is inflated, but to return to the open position or first position when the seal is deflated again.

[0144] Figure 14C A nasal insert 216c is shown having an inflatable auxiliary member 220c. The auxiliary member 220c includes one or more stabilizers 236. The stabilizers 236 can have one or more outer walls and can be inflatable. As such, an inner cavity defined within the stabilizer 236 can be in communication with a gas source, such as flow through an associated sealing member 218c. In the illustrated configuration, the stabilizers 236 can be connected to the base 224c of the nasal insert 216c. When under operating pressure, the expanded stabilizers 236 can provide a force to push the proximal surface of the sealing member toward the user's face. As such, unlike the ring member 234 and the blade member 232, the expanded stabilizers 236 do not serve to hold the un-inflated face mask in an open position; the stabilizers 236 provide improved sealing force during use.

[0145] Referring to Figure 14D , a nasal insert 216d is shown having an auxiliary member 220d that can be flexed between a first position PI and a second position P2. The auxiliary member 220d can include a disc member 238 that is stable in the first position PI and in the second position P2. In some configurations, the disc member 238 can flip between the first position PI and the second position P2, but will return to the first position PI with the application of minimal force. As shown in Figure 14D , the disc member 238 can be flexed into the second position P2 in order to don a face mask. With the disc member 238 in the second position P2, the sealing member 218d can be held in an open position. Once positioned on the user as desired, a slight push of the disc member 238 toward the user's face causes the disc member 238 to spring back into the first position PI, allowing the sealing member 218d to move to a more closed position.

[0146] Thus, in order to don a face mask having the assembly shown in Figure 14D , the disc member 238 can be flexed from the first position PI to the second position P2. The disc member 238 is temporarily stabilized in the second position when the face mask is positioned, such that the nare locators 222d can be positioned within the user's nare. When the face mask is brought into engagement with the user's face, the force exerted by the sealing member 218d is transferred to the disc member 238, which springs back or otherwise returns to the first position PI. With the disc member 238 in the first position, the sealing member 218d can close around the user's tip, allowing the face mask having the assembly shown in Figure 17 to seal around the user's tip.

[0147] Referring now to Figure 15A , a portion of a sealing member 250 is shown. The sealing member 250 can be constructed in accordance with any combination of the features of the constructions described within this specification, for example and without limitation. The sealing member 250 can include a distal wall 252 and a proximal wall 254. An opening 256 can be defined within the distal wall 252. A supply of gas can be delivered into the sealing member 250 through the opening 256.

[0148] As shown in Figure 15A , for example, the distal wall 252 can have a thicker cross section relative to the proximal wall 254. The thicker cross section provides increased rigidity to the distal wall 252 relative to the proximal wall 254. In some configurations, the thickness of the walls can be the same, while the material used has increased rigidity. In some configurations, both the thickness and rigidity of the material can be used to provide varying degrees of rigidity.

[0149] In Figure 15AIn the illustrated configuration, a nare locator 260 can be positioned along the proximal wall 254. The illustrated nare locator 260 can be generally tapered such that it narrows toward the proximal opening 262. As such, the proximal opening 262 can have a smaller diameter than the distal opening into the nare locator 260. In sum, the nare locator 260 can be tapered in the proximal direction.

[0150] To improve the lateral stability of the mask assembly, lateral supports or other support structures can be used. However, in Figures 15A-15D the configuration illustrated in FIG. 1 1, the support structures are shown integrated into the structure of the seal member 250 itself. Referring to Figures 15A-15C , a support structure 270 integrated into the seal member 250 is shown. With the integrated support structure 270, the mask can be more comfortable than other masks that can use separate support structures that are more rigid than the seal member. Further, because the support structure 270 can be directly adjacent to the user's face, the integrated design provides better support to the seal member 250.

[0151] The illustrated support structure 270 can be one or more thickened regions. For example, in cases where the seal member 250 is formed from silicone, the support structure 270 can be a thickened region of silicone. In some such configurations, the support structure 270 can be molded into the seal member 250. In some configurations, foam can be injected or inserted into the support structure 270. For example, in some such configurations, the support structure 270 can be formed with a hollow region (or material can be removed), and the region can be filled with any desired gel or foam material. In some configurations, the support structure 270 can be formed from silicone and the hollow region can be filled with a different grade of silicone. Such a composite support structure can reduce the weight of the seal and mask assembly.

[0152] By molding the support structure 270 into the seal member 250, the support structure can flex with the seal member 250. The flexing of the seal member 250 allows the seal member 250 to better conform to different facial shapes. Additionally, the support structure 270 can move with the seal member 250 and the seal member 250 can be seated closer to the face. Further, integrating the support structure 270 into the seal member 250 simplifies the manufacture of the mask, as the support structure 270 is not separately formed or formed by an over-molding process by integrating the support structure 270 into the seal member 250. Further, the integration reduces the weight of the assembly, while also helping to reduce the size.

[0153] Referring to Figures 15A-15C , the illustrated support structure 270 is a generally crescent-shaped member that underlies the seal member 250. Referring to Figure 15DIn some configurations, the support structure 270 may wrap upwards along one or more of the outer (far) sidewalls 252. Thus, as shown, the support structure 270 can be provided in a variety of shapes. The shape of the support structure 270 can be adapted to provide support for the sealing member 250, wherever desired, because the support structure 270 can be molded into the overall construction. Although Figures 15A-15C The configuration shows a structure that provides support just above the user's lip area, but Figure 15D The configuration redistributes this support to the cheek area rather than the rather narrow area above the lips and below the nose. Therefore, in Figure 15D In this configuration, the support is shifted to the outside, away from the upper lip and towards the cheek. Similar to... Figure 15D In some configurations, the support remains around the lower half of the sealing member 250, even though the support structure 270 wraps vertically upwards along the sidewall. By shifting the position of the support structure 270, the comfort of the sealing member 250 can be improved, as well as the performance of the sealing member 250.

[0154] Now refer to Figure 16-18 Another mask sealing member 280 is shown. This mask sealing member 280 includes a distal wall 282 and a proximal wall 284. One or more nostril locators 286 may be positioned on at least a portion of the proximal wall 284. These nostril locators 286 may have any suitable configuration. In some configurations, these nostril locators 286 taper upwards to an opening 288.

[0155] like Figure 17 As shown, the proximal sidewall 284 proximally wraps around these nostril locators 286. Furthermore, the nostril locator 286 shown spans a portion of the proximal sidewall 284, which is generally perpendicular to the vertical bisecting plane P, and the proximal wrapping portion of the proximal sidewall. Other configurations are possible. In the illustrated configuration, the proximal sidewall 284 extends proximally beyond the nearest side portion of the nostril locator 286. Because the sealing member 280 has laterally extending portions 290 that proximally wrap around the nostrils, these lateral extensions 290 can keep the nostril locators away from the nostrils on a flatter user facial contour. To help provide improved flexibility, the sealing member 280 can be reinforced in an area closer to the nose than the cheek.

[0156] Reference Figure 16, the sealing member 280 can include an edge surface 292 connecting the proximal wall 284 to the distal wall 282. The edge surface 292 in the illustrated configuration is wider at the bottom than at the top. As shown, this edge surface can provide a wider portion on the bottom of the illustrated sealing member 280. This sealing member 280 can have a thicker wall in the bottom corners, while the proximal wall 284 can have a reduced thickness in the area surrounding or at least partially surrounding the nare locator 286. This thicker area of the bottom corners can extend upward and follow the generally vertical line shown in Figure 17

[0157] While a majority of the overall sealing member 280 can be configured for expansion, the thicker area can be configured for less expansion than the area having the reduced thickness. This thicker area can help control the expansion such that the proximal surface experiences the majority of the expansion compared to the edge surface 292 and the distal surface 282. Thus, the area surrounding the nare locator 286 can expand more, while the lower corners expand less, which increases comfort and improves the seal of the mask.

[0158] Referring again to Figure 3 , the nare locators 120 are typically configured to be positioned within the nare. To fit within the nare of a user, these nare locators 120 can be sufficiently rigid to resist crushing during fitting and use. As a result, it has been found that the proximal end of the nare locators 120 slightly pinch the septum or otherwise reduce the comfort of the user. Thus, it can be desirable to remove some of the rigidity of the nare locators 120 and especially the proximal end of these nare locators 120 and / or the transition between these nare locators 120 and the surrounding structure (described below with reference to Figure 29-42 ).

[0159] Referring now to Figure 19 , a sealing member 300 is shown in cross-section. A nare locator 302 is shown extending from a proximal surface 304. The nare locator 302 can include an opening 306. In the illustrated configuration, this opening 306 can be defined by a rim 308. This rim 308 preferably includes at least one interruption 310. Referring to Figure 19 , the illustrated interruption 310 includes a larger opening 312 connected to a slot 314 that intersects the rim 308. In the illustrated configuration, the rim 308 includes two interruptions 310. These interruptions 310 are positioned at the top and bottom of the opening 306 in the illustrated configuration. In other words, when positioned in the nare of a user, these interruptions 310 facilitate flexing in the lateral direction in the configuration shown in Figure 19 .

[0160] ​In some configurations, the rim 308 defining the opening 306 is generally oval and includes a longer axis LI and a shorter axis L2, as shown in Figure 19 In such configurations, the interruptions 310 can be traversed by the longer axis LI. In some configurations, one or more interruptions 310 can be positioned along a portion of the rim 308 that is higher than the shorter axis L2. For example, a single interruption 310 can be positioned on the upper side of the shorter axis L2. In some such configurations, the single interruption 310 can be positioned closer to the vertex of that portion of the oval opening 306. In some such configurations, the single interruption 310 can be traversed by the longer axis LI. In some such configurations, the single interruption 310 can be centered on the longer axis LI.

[0161] With continued reference to Figure 19 , the interruptions 310 define recesses into the nostril locator 302 that extend from the rim 308 into the material of the nostril locator 302. The interruptions 310 can extend any suitable distance along the length of the nostril locator 302. The length is preferably not so long as to create a leak path but long enough to allow for a certain radial back angle from the rim 308. As the length of the interruptions 310 increases, the stiffness of the nostril locator 302 decreases.

[0162] Referring to Figures 20A-20E , other configurations of interruptions 310 are shown. As shown, the interruptions 310 can have many different shapes and can be moved away from the area of the nostril locator 302 that will contact the septum. As shown, the interruptions 310 can be as few as one or as many as desired. In some configurations, the interruptions 310 result in a jagged end to the nostril locator 302. Other configurations are possible.

[0163] Referring now to Figure 21 and Figure 22 , a sealing member 330 is shown. The sealing member 330 can have features, aspects, and properties in common with any other configuration described herein. In the shown configuration, the sealing member 330 includes at least one flexible prong 332. In the shown configuration, the sealing member 330 can include two flexible prongs 332. The flexible prongs 332 include a distal end connected to a proximal surface 334. The flexible prongs 332 can generally extend proximally from the proximal surface 334. The flexible prongs 332 can have one or more openings 336 generally positioned at the proximal end of the prongs 332. In the shown configuration, the opening 336 can form a slit that generally extends perpendicularly through the proximal end.

[0164] The prongs 332 preferably include a stem 340 extending generally between the proximal surface 334 and the opening 336. The stem 340 can be configured for rolling or otherwise easily deflecting. For example, the cross-sectional thickness of the material used to form the seal member 330 and / or the flexible prongs 332 can be reduced to connect at least a portion of the prongs 332 to the seal member 330. In some configurations, a different material or different grade of material can be used to provide increased mobility to the prongs 332.

[0165] In the illustrated configuration, as shown by the comparison between Figure 21 and Figure 22 the prongs 332 can be configured for telescoping or elongation / contraction. By elongating the prongs 332, the prongs 332 can have increased flexibility. As shown, the prongs 332 can be compressed along an axial direction. By compressing, the prongs 332 can improve comfort when sealed against a user's nostril.

[0166] In some configurations, the prongs can be configured with a bellows-like shape. The bellows-like shape can provide axial compressibility. The bellows-like shape can be formed along all or only a portion of the stem 340. By providing the bellows-like shape, the stem 340 can also allow the proximal end of the prong 332 to wobble about the distal end of the prong 332. In other words, the proximal end of the prong 332 can bend in all directions without rotating the prong 332.

[0167] Referring now to Figures 23A-23C , a portion of a seal member 350 is shown. In some configurations, the seal member 350 includes nostril locators 352 similar to those described above. At least a proximal portion of the nostril locators 352 can be partially or entirely covered by end members 354, as shown in each of Figures 23A-23C The end members 354 can be formed of a material that is as soft or softer than the material of the nostril locators 352. In some configurations, the end members 354 can be partially or entirely formed of a softer silicone material. In other words, the end members 354 can be used to provide increased comfort by being positioned over the proximal end of the nostril locators 352.

[0168] The end members 354 can define openings 356 through which airflow from the nare positioner 352 can be delivered. In the illustrated configuration, the end members 354 have a circular appearance. The softer material and the circular shape facilitate rolling about the axis of the nare positioner 352. The underlying nare positioner 352 can be sufficiently rigid to provide structure while the cover formed by the end members 354 can improve comfort. In some configurations, the proximal end of the nare positioner 352 can be covered with perforations or laterally extending openings to allow air to flow out of the nare positioner while the soft end members create a seal with the user's nare. Additionally, in some such configurations, the end members 354 can have a larger outer diameter than the nare positioner 352 such that the nare positioner 352 can have improved flexibility while the end members provide an effective sealing component.

[0169] Referring now to Figure 24 , another sealing member 360 is shown. The sealing member 360 includes a multi-walled nare positioner 362. In the illustrated configuration, the nare positioner 362 includes a thin outer wall 364 and a thicker inner wall 366. In some configurations, the outer wall 364 is spaced apart from the inner wall 366 such that the two walls can move relative to one another. In some configurations, the inner wall 366 can terminate within the outer wall 364. In other words, the outer wall 364 can extend further proximally relative to the inner wall 366.

[0170] For example, but not by way of limitation, the inner wall 366 can include a foam or gel insert. The inner wall 366 underlies the outer wall 364 and supports the outer wall 364. Thus, with the support of the separately formed inner wall 366, the outer wall 364 can be formed from a very thin layer. In some configurations, the outer wall 364 can be a very thin silicone wall that is intermittently or substantially entirely supported by the inner wall 366, which can be a much softer material than the outer wall 364.

[0171] Referring now to Figure 25A and Figure 25B , a sealing member 380 is shown. The sealing member 380 can include one or more nare positioners 382. In some configurations, the sealing member 380 can be configured such that the nare positioner 382 directs airflow in a more superior direction. Referring to Figure 25A , the nare positioner 382 can include a plurality of openings 384. In some configurations, the nare positioner 382 can be configured such that the openings 384 are oriented in a more superior direction. In some configurations, the nare positioner 382 can be configured such that the openings 384 are oriented in a more superior direction and the nare positioner 382 is configured to direct airflow in a more superior direction. In some configurations, the nare positioner 382 can be configured such that the openings 384 are oriented in a more superior direction and the nare positioner 382 is configured to direct airflow in a more superior direction and the nare positioner 382 is configured to direct airflow in a more superior direction. Figure 25BThe nostril locators 382 shown in FIG. 6 are shown directing airflow more rearwardly as compared to the nostril locators 382 shown in FIG. 5. For example, by raising the rearward wall of the nostril locators (see 384), the trajectory of the airflow can be changed to a more upwardly directed flow. In some configurations, the nostril locators are configured such that the resulting airflow is more upwardly and forwardly directed. By redirecting the airflow in this manner, the airflow is not blown directly into the nose, which improves the comfort of the user. In some configurations, the nostril locators 382 can be positioned on a ball joint (for example, but not limited to) such that the airflow can be adjusted as desired by the user.

[0172] Referring now to Figure 26 The illustrated sealing member 400 can be constructed in any of the configurations described above. However, the illustrated configuration is characterized by the omission of the proximal surface 402 of one or both of the nostril locators. In the illustrated configuration, one or more of the nostril locators is replaced by an opening 404 formed in the proximal surface 402. As such, the user's nostrils can only cover the opening 404 formed in the proximal surface. Figure 27 The configuration of FIG. 7 shows a single opening 404 that can be located under one or both of the user's nostrils, while Figure 28 The configuration of FIG. 8 also shows a single protrusion 406 that can help indicate to the user when the mask is properly located under the nose. Referring to Figure 28 In some configurations, the tip of the nose can be located at the intersection 408 of the two facial lines. The protrusion 406 can be a short nostril locator, a full nostril locator, or any suitable structure to help the user confirm the desired positioning of the mask sealing member relative to the nostrils. In some configurations, the nose fits into or around the opening, and the sealing member can expand around the user's nose. For example, the tip of the nose can enter into the opening or the opening can be located under the tip of the nose to provide a seal. The expansion improves the seal of the sealing member, especially without anything extending into the user's nostrils.

[0173] Referring now to Figure 29-42 Another interface assembly 420 is shown arranged and configured in accordance with certain features, aspects, and advantages of the present application. The interface assembly 420 generally includes a frame or body 422 and a seal 424. The seal 424 can be removably secured to the frame 422 for use. In some configurations, multiple seals 424 can be provided for attachment to the frame 422, which can differ in size, shape, softness, or any other desired feature. In the illustrated configuration, the frame 422 provides attachment points for a headgear or the like. Other configurations are possible.

[0174] The illustrated seal 424 incorporates a connection or mounting assembly 426 that can be coupled to a flexible sealing member 428. Referring to Figure 30 The sealing member 428 includes a proximal surface 430 (i.e., the surface that, in use, is closest to the user's face) and a distal surface 432 (i.e., the surface that, in use, is further from the user's face). In the illustrated configuration, the distal surface 432 defines an air inlet 434. The opening 434 is configured to allow breathing gas to enter a chamber defined within the sealing member 428.

[0175] In the illustrated configuration, the opening 434 is defined by a rib or protrusion 436. The rib or protrusion 436 extends in a direction that is generally orthogonal or perpendicular to the axis of the air inlet 434. Figure 34 This is best shown in the cross-sectional view of FIG. 4B. As shown, the portion of the sealing member 428 that connects the rib or protrusion 436 to the distal surface 432 can extend generally orthogonal or perpendicular to the axis of the air inlet 434. As such, the rib or protrusion 436 is offset inwardly by a portion of the distal surface 432. This radial offset allows the rib or protrusion to be captured by the mounting assembly 426. Other configurations are possible, given the desire to lay a more rigid mounting assembly 426 onto the sealing member 428.

[0176] The mounting assembly 426 can be more rigid than the sealing member 428. In some configurations, the mounting assembly 426 can be formed as a two-piece construction. For example, the mounting assembly 426 can capture the sealing member 428 having an inner member 438 and an outer member 440. The inner member 438 can be inserted through the air inlet 434.

[0177] The inner member can have a sleeve 442 that extends through the air inlet 434. The sleeve 442 can engage a larger diameter ridge 444. The larger diameter ridge 444 can provide a location against which the rib or protrusion 436 of the sealing member 428 can rest. The sleeve 442 can be provided with external threads or include one or more external protrusions 444. The sleeve 442 can also include an internal coupler construction 446. These external threads or protrusions 444 can be tightly coupled with structures formed on the inner surface of the outer member 440. The outer member extends radially outwardly sufficiently to capture the rib or protrusion 436 of the sealing member 428 between the outer member 440 and the inner member 438. In this manner, the mounting assembly 426 can be secured to the sealing member 428.

[0178] As described above, the sleeve 442 of the inner member 438 includes an internal coupler formation 446. The internal coupler formation 446 mates with a corresponding structure on the frame 422, such that the seal 424 (i.e., the sealing member 428 and the mounting assembly 426) can be secured to the frame 422 for use and removed for replacement. The frame 422 can have a flange or the like to which the mounting assembly 426 can connect. In the illustrated configuration, the entry portion of the frame 422 (i.e., the socket for the ball-and-socket connection) can incorporate a recess, while the mounting assembly 426 can incorporate a ridge, although other suitable formations can be used, given the desire for a secure connection for use, as opposed to a removable connection for replacement of the seal 424.

[0179] In some configurations, the frame 422 and the mounting assembly 426 can include orientation features. For example, in the illustrated configuration, the mounting assembly 426 can incorporate a tongue, tab, or raised feature 448, while the frame 422 can incorporate a groove, recess, or release feature 450. With the tongue 448 aligned with the groove 450, the desired orientation between the seal 424 and the frame 422 can be established. Other suitable configurations can be used, given the desire for confirmation of proper alignment and orientation of the seal 424 and the frame 422.

[0180] Reference will now be made in detail to the sealing member 428, which has a preferred configuration. Figure 35-42 The sealing member 428 can have regions of increased softness and regions of increased hardness, as already described. These regions can result from different materials, different grades of the same material, or different thicknesses. In the illustrated configuration, there are regions of different thicknesses. The thickest regions on the proximal surface 430 (shown in Figures 35-37 ) and on the distal surface 432 (shown in Figures 38-40 ) can be found in the ribs or tabs 436 around the air inlet 434 or in the central portions of the wings 452. These regions are regions for mounting and for gripping, and thus, desirably, are the thickest and hardest regions. In addition, as described in more detail below, at least in the wing regions 452, the thickest regions can support the thinner regions and provide some structure to the sealing member 428. In some configurations, the thickness is 3.0 mm, given the desire for the regions to be sufficiently rigid for mounting and gripping, with some variations possibly being slightly higher and lower.

[0181] The next thickest region is the junction region 454 that joins the rib or protrusion 436 to the balance of the sealing member 428. This region is simply thick enough to resist tearing of the sealing member 428 at the junction between the rib or protrusion 436 and the balance of the sealing member 428. In some configurations, the junction region 454 has a thickness of about 1.0 mm, with some variations possibly being somewhat higher and lower, in view of the desire to reduce or eliminate the possibility of tearing during normal use.

[0182] As noted above, the nostril locators 456 can be positioned on the proximal surface 430. These nostril locators 456 are desirably soft enough to reduce or eliminate the possibility of causing irritation. These nostril locators 456 are also desirably stiff enough to reduce the possibility of collapsing or being insufficiently self-supporting to provide an indication to the user of the proper position and orientation of the seal 424 relative to the face. Preferably, these nostril locators 456 have sufficient stiffness to resist or prevent substantial collapse in response to positioning of the locators 456 in the user's nostrils. In some configurations, the nostril locators 456 can have a thickness of about 0.7 mm, with some variations possibly being somewhat higher and lower, in view of the desire to reduce user discomfort while still assisting in mask positioning.

[0183] As noted above, some regions of the sealing member 428 can be configured for expansion, inflation, etc. By having such expandable surfaces, the sealing member 428 can provide a more effective seal while accommodating slight movement of portions of the sealing member 428 in use relative to the user's face. In effect, the nostril locators 456 can be somewhat decoupled from the frame 422 by the softest regions of the sealing member 428, which in the illustrated configuration surround the nostril locators 456 and isolate the nostril locators 456 from the balance of the mask. As such, a surrounding region 458 can be defined that generally surrounds the nostril locators 456. This surrounding region 458 can extend to the transition between the proximal surface 430 and the distal surface 432. In some configurations, the surrounding region 458 has a thickness of about 0.25 mm, with some variations possibly being somewhat higher and lower, in view of the desire to allow some decoupling between the relatively more rigid nostril locators 456 and the balance of the sealing member 428.

[0184] Except for the identified regions, the remainder of the illustrated sealing member 428 can be a transition in wall thickness among the identified wall thicknesses. The illustrated sealing member 428 is simply one desired configuration and some variations are possible.

[0185] As noted above, especially as Figure 41As shown in the figures, the side portions or wing regions 452 can include hardened regions in the form of thickened regions 470 of the thinner regions (e.g., the peripheral regions 458) of the body that support the sealing member 428. These thickened regions 470 can be mirror images of one another, as with the wing regions 452, such that the sealing member 428 has symmetry about a central, vertical plane. These thickened regions 470 can extend along a substantial portion of the length and / or height of the wing regions 452 or the sealing member 428. In the illustrated arrangement, these thickened regions 470 extend substantially along the entire length and approximately the entire height of the wing regions 452, which can extend approximately the entire height and length of the sealing member 428. Thus, in some configurations, these thickened regions 470 are substantially the same size and shape as the distal surface 432 of the wing regions 452.

[0186] The thickened regions 470 can have a substantially constant or variable thickness. In the illustrated arrangement, the peripheral or edge portions of the thickened regions 470 decrease in thickness relative to the central portions of the thickened regions 470. In particular, the leading edge portions of the thickened regions 470 decrease in thickness relative to the adjacent and / or central portions and transition into the joining regions 454 and the ribs 436 to accommodate the mounting assembly 426. Preferably, the leading edge portions of the thickened regions 470 have a greater thickness than the joining regions 454 at least up to the junction between the thickened regions 470 and the joining regions 454. In the illustrated configuration, the leading edge portions of the thickened regions 470 gradually decrease in thickness toward the junction with the joining regions 454.

[0187] Similarly, the trailing edge portions of the thickened regions 470 also decrease in thickness relative to the adjacent and / or central portions of the thickened regions 470. This arrangement preserves the softness of the trailing edge portions of the proximal surface 430 while inhibiting or preventing excessive bulging or expansion of the trailing edge portions of the distal surface 432. Advantageously, this arrangement allows the sealing member 428 to provide adequate sealing function on the lateral portions of the user's nose while also providing a stable feel for the user, as any excessive bulging of the trailing edge portions of the distal surface 432 can be limited or avoided.

[0188] Referring to Figure 41The rear edge of the sealing member 428 (which rear edge can also be referred to as a rim or edge surface) can include a transition portion 472 between the proximal surface 430 and the distal surface 432. In the illustrated configuration, the transition portion 472 includes a generally rounded or curved wall portion. As noted above, in some configurations, the thickened region 470 tapers in thickness anteriorly of the transition portion 472. Preferably, however, a portion of the transition portion 472 has a greater thickness than the soft proximal surface 430 or the surrounding region 458 in order to control the expansion of the sealing member 428, and preferably limit or prevent any substantial expansion of the distal surface 432. In the illustrated arrangement, the rear edge portion of the thickened region 470 tapers in thickness relatively quickly toward the transition portion 472, which rear edge portion then gradually tapers in thickness from the distal surface 432 to the proximal surface 430. In some configurations, the transition portion 472 can have a portion that defines approximately the same wall thickness as the soft proximal surface 430, such as the surrounding region 458.

[0189] As Figures 29-31 As shown in Figs. 35, 36, and 38-40 (and possibly in other figures), the lower rear corners of the wing regions 452 include outwardly projecting portions or outwardly projecting corners 474. These outwardly projecting corners 474 flare outwardly relative to the adjacent portions of the wing regions 452 so as to be generally positioned at a location corresponding to the lateral outward cheek or upper lip of the user's nose. In some configurations, these outwardly projecting corners 474 are located generally above the portion of the upper lip that overlies the user's canine or incisor teeth. These outwardly projecting corners 474 can assist in anchoring the sealing member 428 to the user's face. In some configurations, this arrangement allows for the omission of additional stabilizing elements while still providing a sufficiently stable feel to the user, such that the sealing member 428 is the only portion of the mask that contacts the user's face. At least in part due to the relatively high stiffness of these outwardly projecting corners 474, a stable feel can be communicated to the user. Thus, preferably, the thickened region 470 can extend at least partially into these outwardly projecting corners 474, and in some configurations, can extend at least substantially completely through these outwardly projecting corners 474. Preferably, at least the last and lowermost portions of the distal surface 432 of the seal 424 include the thickened region 470. Within these outwardly projecting corners 474, these thickened regions 470 can taper in thickness into the transition portion 472, as described above.

[0190] As noted above, among other reasons, the wing regions 452 can be used as gripping portions of the seal 424 for initial positioning of the mask on the face, repositioning of the mask on the face, removal of the seal 424 from the frame or body 422, or coupling the seal 424 to the frame or body 422. As noted above, these thickened regions 470 can facilitate gripping on the distal surface of the seal 424 within the wing regions 452 by limiting collapse of the seal 424 in response to pinching of the wing regions 452. In some configurations, the distal surface 432 of the seal 424 can include surface features (e.g., one or more recesses or protrusions) configured to facilitate gripping. Such components can be referred to as gripping surfaces or grips.

[0191] The illustrated wing regions 452 each include a gripping surface 480 formed by a protrusion 482. The protrusion 482 extends outwardly from the adjacent surface to an extent sufficient to provide some resistance to sliding of a user's finger along the surface of the seal 424. The illustrated protrusions 482 are generally crescent-shaped, which defines a generally scallop-shaped gripping surface 480. The ends of the protrusion 482 are positioned posterior to the center, curved portion of the protrusion 482. When installing the seal 424 to the frame or body 422, a user's finger or thumb can be placed on the gripping surface 480 and the user can press on the protrusion 482. Thus, the protrusion 482 compensates for the inwardly tapering or curved shape of the seal 424, which might otherwise allow a user's finger or thumb to slide along the distal surface 432 of the seal 424. The gripping surface 480 and / or protrusion 482 can also assist a user in removing the seal 424 from the frame or body 422 or otherwise positioning or repositioning the mask. Other suitable gripping arrangements can also be provided, such as multiple protrusions, recesses, or other surface features that enhance gripping over a smooth surface. Material or material treatment that improves gripping can also be employed.

[0192] The seal 424 can alternatively or additionally include other features that define a gripping surface or grip. For example, with reference to Figure 29 、 30and 32, the seal 424 can include a relatively rigid grip 484. In the illustrated arrangement, the rigid grip 484 is defined by a rigid support member of the seal 424, such as the mounting assembly 426, and in particular, the outer member 440 of the mounting assembly 426. The illustrated grip 484 is defined by a rearwardly projecting portion or tab of the outer member 440, which can extend rearward of the annular portion of the outer member 440 on the distal surface 432 of the seal 424. The seal 424 can define a recess that receives the grip 484, and an outer surface of the grip 484 can be aligned with an adjacent outer surface of the seal 424. The inner member 438 can include a portion 486 that is aligned with the grip 484 that also extends generally rearward but within the interior space of the seal 424, so as to grip the seal between the grip 484 and the rearwardly extending portion 486 of the inner member 438. The grip 484 can define one or more surface features 488, such as one or more projections or recesses, that enhance gripping.

[0193] The illustrated grip 484 is located on the top of the seal 424. Additional or alternative locations include the bottom of the seal 424 or either side of the seal 424. For example, opposing pairs of grips 484 can be provided on the top and bottom and / or sides of the seal 424. In some configurations, the gripping surfaces 480 and / or projections 482 can be defined by a rigid structure, such as a portion of the mounting assembly 426 (e.g., the outer member 440). In some configurations, the mounting assembly 426 can include a projecting portion or other rigid portion that can extend a substantial length and / or height of the wing region 452 of the seal 424.

[0194] As noted above, the nostril positioners 456 can be at least somewhat decoupled from the balancing member of the seal member 428. In some configurations, the seal member 428 can be configured to provide or facilitate preferential movement of the nostril positioners 456. In some such configurations, the seal member 428 can be configured to provide less resistance to tilting movement in at least one direction relative to at least one other direction. Preferably, the seal member 428 includes one or more features that provide or facilitate tilting of the nostril positioners 456 outward away from each other. That is, preferably, less resistance is provided for outward tilting of the nostril positioners 456 relative to tilting in one or more other directions (e.g., inward, upward, or downward). Such an arrangement can reduce discomfort that can otherwise occur due to pinching of the user's nasal septum by the nostril positioners 456. The arrangements disclosed herein can be applied to other types of seals or patient interfaces, such as any arrangement incorporating a nasal pillow or other sealed or non-sealed pronged nasal element.

[0195] Any suitable arrangement or structure can be used to provide or facilitate preferential movement of the nare positioner 456. In the illustrated arrangement, the sealing member 428 includes thinned regions that extend around at least a portion of the nare positioner 456, which facilitate tilting or deflection of the nare positioner 456 and are referred to herein as deflection regions 490. In some configurations, the deflection regions 490 are located in annular transition portions around the nare positioner 456 between the nare positioner 456 and the surrounding region 458. The transition portions can be formed in part or in whole by a base portion of the nare positioner 456, by a portion of the surrounding region 458 adjacent to the base portion of the nare positioner 456, or by a combination of the two. In other configurations, the deflection regions 490 can be provided in another suitable location to allow preferential deflection of the nare positioner 456.

[0196] In some configurations, the deflection regions 490 are located on the base of the nare positioner 456, and in the illustrated arrangement, are substantially entirely on the base of the nare positioner 456. The deflection regions 490 can include thin-walled segments of the base of the nare positioner 456. The thin-walled segments have a smaller thickness than other portions of the nare positioner 456. In some configurations, the thin-walled segments defining the deflection regions 490 can be the thinnest portions of the nare positioner 456. In some configurations, the thin-walled segments have a wall thickness that is about one-half or less than about one-half of the wall thickness of the majority or remaining portion of the nare positioner 456. For example, in some configurations, the thin-walled segments of the deflection regions are about 0.35 mm thick and at least the main portion of the nare positioner 456 is about 0.8 mm thick. In some configurations, the tips of the nare positioner 456 are thinned for comfort. However, with the deflection regions 490 provided, the tips can be the same or substantially the same wall thickness as other portions of the nare positioner 456, improving user feedback and inhibiting collapse when inserted into the nare while also being comfortable during use. The thin-walled segments defining the deflection regions 490 can have a greater thickness than the surrounding region 458.

[0197] The deflection regions 490 preferably extend around only a portion of the corresponding perimeter of the nare positioner 456. In some configurations, the deflection regions 490 are limited to about one-half or less of the perimeter of the nare positioner 456. In some configurations, the deflection regions 490 are limited to the outer side of the perimeter of the nare positioner 456. In the illustrated arrangement, the deflection regions 490 extend around greater than or equal to about one-third of the corresponding perimeter of the nare positioner 456, but less than or equal to about one-half of the corresponding perimeter of the nare positioner 456.

[0198] With particular reference to Figure 42The outlet holes 492, defined by the nostril locator 456, are generally elliptical in shape and each defines a major axis 494 along the maximum width of the outlet holes 492 and a minor axis 496 perpendicular to the major axis 494. In some configurations, these deflection regions 490 are substantially or completely confined to one side (e.g., the outer side) of the major axis 494. The lower ends of these deflection regions 490 may be located at or near the major axis 494, and the upper ends of these deflection regions 490 may be spaced apart from the major axis 494. This arrangement allows for tilting in an outward and slightly downward direction relative to the major axis 494. The length and / or position of these deflection regions 490 can be varied to provide the desired direction of tilting or deflection. In some configurations, if the lower end of the major axis 494 is assumed to be 0 degrees, then these deflection regions 490 may extend from about 5 degrees to about 150 degrees.

[0199] At least in part because of these deflection regions 490 and other feature structures described herein, Figure 29-42 The geometry of sealing component 428 is already relative to that of the current respondent, Fisher & Paykel Healthcare Limited. The geometry of the commercially available nasal seal for nasal masks has been modified. For example, the major axis 494 has been adjusted relative to the current... The nose mask is rotated approximately 10 degrees vertically. The major axes 494 are oriented at an angle of approximately 20-25 degrees to their lower ends relative to the central vertical plane passing through the sealing member 428, these lower ends being further outward (further away from the central plane) than the upper ends of the major axes 494. The surface defining the tip of the nostril locator 456 is already relative to the current... The nasal mask is rotated outward by approximately 4 degrees, so that these surfaces are defined at an angle of approximately 20-25 degrees to the central plane, while the outer portion of the tip of the nostril locator 456 is further rearward than the inner portion. The length of these nostril locators 456 has been reduced by approximately 1 mm to approximately 11 mm. The outlet hole 492 is defined in a more rounded shape. For example, the dimension along the major axis 494 can be approximately 10 mm and the dimension along the minor axis can be approximately 5.5 mm. These nostril locators 456 are also slightly wider spaced. For example, the distance between the major axis 494 and the tip of the nostril locator 456 at the base can be approximately 18.5 mm and approximately 11 mm, respectively.

[0200] Reference Figure 43FIG. 5 shows another interface assembly 500 arranged and constructed in accordance with certain features, aspects, and advantages of the present application. The interface assembly 500 generally includes a frame or body 502 and a seal 504. The seal 504 can be removably secured to the frame 502 for use. In the illustrated configuration, the frame 502 provides attachment points for a headgear or the like. The illustrated seal 504 incorporates a connection or mounting assembly 506 that can be joined to a flexible sealing member 508. The sealing member 508 includes a proximal surface 530 (i.e., the surface that, in use, is closest to the face of the user) and a distal surface 532 (i.e., the surface that, in use, is further from the face of the user). The interface assembly 500 is described in the context of differences relative to other interface assemblies described herein. Thus, features not described can be assumed to be the same as or similar to corresponding features of other interface assemblies disclosed herein, or can have another suitable arrangement.

[0201] Figure 43 The sealing member 508 preferably includes features that facilitate or promote deflection of an upper, central portion of the sealing member 508 that is aligned with the nose of the user so as to inhibit or prevent excessive pressure from being applied to the nose. In some configurations, portions of both the proximal surface 530 and the distal surface 532 of the sealing member 508 defined in the central portion are deflected forward to accommodate the nose of the user. That is, in some configurations, the entire upper, central portion of the sealing member 508 can be deflected in a forward direction, rather than the proximal surface 530 simply moving closer to the generally substantially stationary distal surface 532, which movement can cause stretching of the proximal surface 530 and thus result in discomfort. Deflection of the sealing member 508 can not occur in all situations. For example, certain facial geometries can result in little or no deflection, while other facial geometries can result in significant deflection.

[0202] The illustrated sealing member 508 includes a rib or protrusion 536 that provides a connection to the connection or mounting assembly 506. The joint region 554 can connect the rib or protrusion 536 to the counterpiece of the sealing member 508. In some configurations, portions of the joint region 554 can have a thickness of about 1.0 mm, with certain variations possibly being somewhat higher and lower, in view of the desire to reduce or eliminate the possibility of tearing during normal use. However, an upper, central portion 560 of the sealing member 508 (which portion can include portions of the joint region 554) preferably has a lower wall thickness to facilitate or promote deflection (shown in dashed lines). The wall thickness of the upper, central portion 560 can be less than the wall thickness of the joint region 554, and can be less than the wall thickness of the distal surface 532. Figure 29-42The peripheral region 458 of the sealing member 428 is the same or similar, for example, as the peripheral region 458 of the sealing member 428, for example, like about 0.25 mm. In some configurations, the upper, central portion 560 can be connected to or integrated with the peripheral region 558 of the nasal hole positioner 556 that surrounds the sealing member 508. In the illustrated arrangement, the reduced wall thickness of the upper, central portion 560 begins substantially immediately outside of the connection or mounting assembly 506. Other suitable arrangements that permit deflection and / or rolling movement of the upper, central portion 560 of the sealing member 508 can also be used, such as the concepts and arrangements disclosed in WO 2014 / 062070, which is incorporated herein by reference in its entirety.

[0203] Throughout this specification and claims, unless the context requires otherwise, the word "comprise," "comprising," and the like are to be construed in an inclusive sense, as "including, but not limited to."

[0204] Any reference in this specification to any prior publication, whether a patent, patent application, scientific article, or otherwise, is not, and should not be taken as an acknowledgment or any form of suggestion that this prior publication forms part of the common general knowledge in the field of endeavour in any country.

[0205] The application can also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements or features.

[0206] In the preceding specification, reference has been made to the integrals or parts having known equivalents where appropriate. Such integrals are incorporated by reference herein, as if individually set forth.

[0207] It is noted that modifications and variations to the present preferred embodiments described herein will be apparent to those skilled in the art. Accordingly, it is to be understood that although preferred embodiments have been presented for purposes of example, modifications and variations can be made therein without departing from the spirit and scope of the application. For example, various components can be repositioned as desired. It is therefore contemplated that this application can encompass various modifications and variations. Further, not all features, aspects, and advantages are necessarily required to practice the application. Accordingly, the scope of the application is intended to be limited only by the claims that follow.

Claims

1. A nasal seal configured to be removably attached to a frame of a patient interface, the nasal seal comprising: A sealing body formed of a soft, flexible material and defining an inner cavity and one or more delivery openings for supplying respiratory gas from the inner cavity to a patient, wherein the one or more delivery openings include a first delivery opening and a second delivery opening, and also includes a nostril locator associated with each delivery opening and forming part of each delivery opening; The sealing body includes a central portion and side portions extending from each end of the central portion, the sealing body further including an inner side and an outer side; wherein the inner side of the central portion is configured to extend over a base beyond the user's nose, and the inner side of each side portion is configured to extend over a side of the nose; wherein the inner side of the nasal seal is flexible and configured to conform to the surface of the user's nose under internal pressure, the surface conforming to the user's nose under internal pressure including an outer surface conforming to the side of the nose at the side portion of the nasal seal; and wherein the central portion of the sealing body defines a thinning region that allows the upper portion of the inner side of the central portion to move forward due to rolling movement of the sealing body.

2. The nasal seal as claimed in claim 1, wherein, Each side portion defines a transition section between the outer and inner sides; wherein the outer side of each side portion includes a hardened region that is harder or much harder than the soft inner side, the hardened region extending to or substantially extending to the transition section.

3. The nasal seal as described in claim 2, wherein, The hardened area is formed by the relatively thickened portion of the sealing body.

4. The nasal seal as described in claim 3, wherein, The thickened portion gradually decreases in thickness before the transition portion.

5. The nasal seal as described in claim 4, wherein, The transition section includes a portion that is thicker than the soft inner side.

6. The nasal seal as claimed in claim 1, wherein, The hardened area extends essentially along the entire length of the outer surface of the sealing body.

7. The nasal seal as claimed in claim 1, wherein, The transition section includes circular wall segments.

8. The nasal seal as claimed in claim 1, wherein, The hardened areas are located in the last and lowest sections of the side portion.

9. The nasal seal as claimed in claim 8, wherein, The last and lowest sections of the side portion open outward relative to the adjacent portion of the sealing body.

10. The nasal seal as claimed in claim 1, wherein, The deflection region is defined within an annular transition portion between each nostril locator and the surrounding portion of the inner surface, wherein the deflection region has a lower hardness relative to another area of ​​the annular transition portion that is not within the deflection region.

11. The nasal seal as claimed in claim 10, wherein, This lower stiffness is achieved by making the deflection region thinner than other areas of the annular transition section.

12. The nasal seal as claimed in claim 10, wherein, The deflection area is located on the outer surface of the nostril locator.

13. The nasal seal as claimed in claim 12, wherein, The deflection zone provides less resistance to tilting the nostril locator outward compared to tilting it in one or more other directions.

14. The nasal seal as claimed in claim 10, wherein, The deflection region is limited to being less than or equal to half of the annular transition section.

15. The nasal seal as claimed in claim 14, wherein, The deflection region is greater than or equal to one-third of the annular transition section.

16. The nasal seal as claimed in claim 10, wherein, The upper part of the inner side of the central part is connected to or integrated into the surrounding part of the inner side.

17. The nasal seal as claimed in any one of claims 1-16, further comprising a support member formed of a relatively rigid material and supporting a portion of the sealing body.

18. The nasal seal as claimed in claim 17, wherein, The support defines at least one gripping surface portion extending along the outer side of the sealed body.

19. The nasal seal as claimed in claim 18, wherein, The at least one gripping surface portion includes at least a pair of gripping surface portions that are substantially opposite to each other.

20. The nasal seal as claimed in claim 17, wherein, The support defines the mounting components for attaching the nasal seal to the frame.

21. The nasal seal as claimed in claim 20, wherein, The mounting includes a first component that can be attached to a second component, and a portion of a sealing body is captured between the first and second components.

22. The nasal seal as claimed in claim 21, wherein, The first component is positioned within the inner cavity of the sealing body and includes a sleeve portion extending outward from the inner cavity.

23. The nasal seal as claimed in claim 22, wherein, The second component is the sleeve portion surrounding the first component.

24. The nasal seal as claimed in claim 21, wherein, The outer surface of the sealing body defines an air inlet that allows breathing gas to enter the inner cavity of the sealing body, and the portion of the sealing body trapped between the first member and the second member includes ribs or protrusions that define the air inlet.

25. The nasal seal as claimed in claim 24, wherein, The ribs or protrusions are offset inwards through a portion of the outer surface that extends generally orthogonally or perpendicularly to the intake axis.

26. The nasal seal as claimed in claim 23, wherein, The second component includes at least one gripper, which includes a portion or ear piece extending rearward above the outer side of the nasal seal.

27. The nasal seal as claimed in claim 26, wherein, The nose seal includes a recess for receiving the gripper.

28. The nasal seal as claimed in claim 27, wherein, The first component includes a portion that extends rearward in generally aligned manner with the gripper and is located within the cavity of the nasal seal.

29. The nasal seal as claimed in claim 26, wherein, The at least one gripper is located on top of the nose seal.

30. The nasal seal as claimed in claim 26, wherein, The at least one gripper is located at the bottom of the nose seal.

31. The nasal seal as claimed in claim 26, wherein, The at least one gripper is located on the side of the nose seal.

32. The nasal seal as claimed in claim 26, wherein, The at least one gripper includes at least a pair of opposing grippers.

33. The nasal seal as claimed in claim 20, wherein, The frame and mounting components include orientation feature structures to confirm that the nose seal is correctly aligned and oriented with the frame.

34. The nasal seal as claimed in claim 33, wherein, Mounting elements include tongues, protrusions, or raised features, and frames include recesses, recesses, or release features.

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