Patient interface and its form

Abstract

To provide an improved sealing member for use in mask assemblies that overcomes the shortcomings of conventional sealing members. [Solution] The patient inflation interface has a frame that supports a sealing member. The frame and / or sealing member are secured to the user's head with headgear such as a strap. Various features of the sealing member improve user comfort in the user's nostrils as well as the face that comes into contact with the sealing member.

Description

Technical Field

[0001] Incorporation by reference to any prior application All applications in which foreign or domestic priority claims are identified within the application data sheet filed together with this application are hereby incorporated by reference herein in their entirety and made part of this disclosure.

[0002] The present invention generally relates to an interface for supplying pressurized gas to a recipient.

Background Art

[0003] Respiratory gases can be delivered to a user in 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's lungs. Additionally, a mask can be used to deliver continuous positive airway pressure (CPAP) or variable airway pressure to treat medical disorders such as obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or congestive heart failure (CHF).

[0004] These non-invasive ventilation and pressure support therapies generally require placement of a user interface device, typically a nasal mask or nasal / oral mask, on the user's face. The flow of respiratory gas can be delivered through the mask from a pressure / flow generating device to the user's airway.

[0005] Typically, a patient interface device includes a mask frame that supports a sealing member. The sealing member contacts the user's facial surface including the area surrounding the nose including the nose and nostrils. Such masks are typically worn for long periods of time and thus various concerns must be taken into account. For example, when performing CPAP to treat OSA, the user typically wears the mask throughout the night while sleeping. One concern in such a situation is that the mask should be as comfortable as possible. It is also important that the mask provide a sufficient seal against the user's face without significant discomfort.

Summary of the Invention

[0006] Therefore, an object of a particular embodiment of the present invention is to provide an improved sealing member for use in a mask assembly that overcomes the shortcomings of conventional sealing members. [Means for solving the problem]

[0007] Depending on the configuration, a nasal seal, configured to be removably connected to a patient interface or a frame of a patient interface incorporating the seal, is formed from a soft, flexible material and includes a seal body defining an internal cavity and one or more outlets for supplying respiratory gases from the internal cavity to the patient. The seal body comprises a central portion and lateral portions extending from each end of the central portion. The seal body further comprises internal and external sides, the internal side of the central portion configured to extend across the base of the user's nose, and the internal side of each lateral portion configured to extend across the sides of the nose. The internal side of the seal is flexible and configured to conform to the surface of the user's nose, including the outer surface of the sides of the nose, under internal pressure. Each lateral portion defines a transition between the external and internal sides, and the external side of each lateral portion comprises a reinforcing region that is harder or much harder than the flexible internal side, the reinforcing region extending to or substantially to the transition.

[0008] In some such configurations, the reinforced area is formed by a relatively thick portion of the seal body. The thickness of the thick portion may gradually decrease before the transition portion. The transition portion may include a portion that is thicker than the flexible inner side.

[0009] In some such configurations, the reinforcing region extends substantially along the entire length of the outer surface of the seal body.

[0010] In some such configurations, the transition section features a rounded wall section.

[0011] In some such configurations, the support is formed from a relatively rigid material and supports a portion of the seal body. The support may define at least one grip surface portion extending along the outer surface of the seal body. The at least one grip surface portion may comprise at least one pair of grip surface portions substantially opposite each other.

[0012] In some such configurations, the support defines a fixture for attaching the nose seal to the frame. The fixture may comprise a first member connectable to a second member, and the first and second members capture a portion of the seal body between them. The first member may be positioned within the cavity of the seal body and may have a sleeve portion extending outward from the cavity. The second member may surround the sleeve portion of the first member.

[0013] In some such configurations, the reinforcement region is located within the rearmost and lowest sections of the side portion. The rearmost and lowest sections of the side portion may extend outward relative to the adjacent portions of the seal body.

[0014] In some such configurations, one or more outlets comprise a first outlet and a second outlet. The nasal seal may further comprise a nostril locator associated with and forming a portion of each outlet, and a flex region is defined within the annular transition portion between each nostril locator and the surrounding portion of the inner side surface. The flex region has lower stiffness than another region of the annular transition portion that is not within the flex region.

[0015] In some such configurations, lower stiffness is achieved by a flexure region that is less thick than other areas of the annular transition. The flexure region may be located on the lateral side of the nostril locator. The flexure region can be limited to less than half the thickness of the annular transition.

[0016] In some such configurations, the central portion of the seal body defines a thin-walled region that allows the upper part of the inner side of the central portion to move forward as a result of the rotational motion of the seal body.

[0017] Depending on the configuration, a nasal seal, configured to be removably connected to a patient interface or a frame of a patient interface incorporating the seal, is formed from a soft, flexible material and includes a seal body defining an internal cavity and one or more outlets for supplying respiratory gases from the internal cavity to the patient. The seal body comprises a central portion and lateral portions extending from each end of the central portion. The seal body further comprises internal and external sides, the internal side of the central portion configured to extend across the base of the user's nose, and the internal side of each lateral portion configured to extend across the sides of the nose. The internal side of the seal is flexible and configured to conform to the surface of the user's nose, including the outer surface of the sides of the nose, under internal pressure. The external side of each lateral portion comprises a reinforcing region that is harder or much harder than the flexible internal side, the reinforcing region located within the rearmost and lowest sections of the lateral portion.

[0018] In some such configurations, the rearmost and lowest sections of the side portion extend outward relative to the adjacent portions of the seal body.

[0019] In some such configurations, the flared lateral portion is positioned roughly in alignment with the surface of the user's cheek or upper lip and outward laterally from the nose.

[0020] In some such configurations, the reinforced area is formed by a relatively thick portion of the seal body.

[0021] In some such configurations, the thickness of the thicker sections gradually decreases before the transition between the inner and outer surfaces.

[0022] In some such configurations, the transition area includes a portion that is thicker than the flexible inner side.

[0023] Depending on the configuration, a nasal seal configured to removably couple to a frame of a patient interface incorporating the patient interface or seal is formed from a soft, flexible material and includes a seal body defining an internal cavity and one or more outlets for supplying breathing gas from the internal cavity to the patient. The seal body includes a central portion and side portions extending from each end of the central portion. The seal body further includes an inner side surface and an outer side surface. The inner side surface of the central portion is configured to extend across the root of the user's nose, and the inner side surface of each side portion is configured to extend across the side of the nose. The inner side surface of the seal is flexible and configured to conform to the surface of the user's nose, including the outer surface of the side of the nose at the side portions of the seal, under internal pressure. The outer side surface of each side portion includes a reinforcing region that is harder or much harder than the flexible inner side surface. The outer side surface of the seal body further defines a grip surface on each side portion, and the grip surface is located on the reinforcing region.

[0024] In some such configurations, the grip surface is formed by protrusions.

[0025] In some such configurations, the protrusions are generally crescent-shaped, thereby defining a generally scallop-shaped grip surface.

[0026] In some such configurations, the ends of the protrusions are positioned behind the central curved portion of the protrusions.

[0027] Depending on the configuration, a nasal seal configured to be removably coupled to a frame of a patient interface or a patient interface incorporating a seal is formed from a soft, flexible material and includes a seal body defining an internal cavity and one or more outlets for supplying breathing gas from the internal cavity to the patient. The seal body includes a central portion and side portions extending from each end of the central portion. The seal body further includes an inner side surface and an outer side surface. The inner side surface of the central portion is configured to extend across the root of the user's nose, and the inner side surface of each side portion is configured to extend across the side of the nose. The inner side surface of the seal is flexible and configured to conform to the surface of the user's nose, including the outer surface of the side of the nose at the side portions of the seal, under internal pressure. The nasal seal is formed from a relatively rigid material and further includes a support that supports a portion of the seal body. The support defines at least one grip surface portion extending along the outer side surface of the seal body.

[0028] In some such configurations, the support defines at least one grip surface portion extending along the outer side surface of the seal body.

[0029] In some such configurations, the at least one grip surface portion includes at least one pair of grip surface portions that are substantially opposed to each other.

[0030] In some such configurations, the support defines a fixture for attaching the nasal seal to the frame.

[0031] In some such configurations, the fixture includes a first member that can be coupled to a second member, and the first member and the second member capture a portion of the seal body therebetween.

[0032] In some such configurations, the first member is positioned within the cavity of the seal body and includes a sleeve portion extending outwardly from the cavity.

[0033] In some such configurations, the second member surrounds the sleeve portion of the first member.

[0034] Depending on the configuration, a nasal seal, configured to be removably connected to a patient interface or a frame of a patient interface incorporating the seal, is formed from a soft, flexible material and includes a seal body defining an internal cavity. The seal body comprises a central portion and lateral portions extending from each end of the central portion. The seal body further comprises internal and external sides. The internal sides of the central portion are configured to extend across the base of the user's nose, and the internal sides of each lateral portion are configured to extend across the sides of the nose. The internal sides of the seal are flexible and, under internal pressure, are configured to conform to the surface of the user's nose, including the outer surface of the sides of the nose at the lateral portions of the seal. The seal body includes a first and second outlet for supplying breathing gas from the internal cavity to the user's nostrils. Nasal locators are associated with and form a portion of each outlet. A flexure region is defined within the transition between each nasal locator and the peripheral portion of the internal side. The deflection region has lower hardness than other regions in the transition area that are not within the deflection region.

[0035] Depending on the configuration, the deflection region may be thinner than other regions of the transition area.

[0036] Depending on the configuration, the flexure region is located outside the nostril locators, making it easier for the nostril locators to move outward and away from each other.

[0037] Depending on the configuration, the deflection region may be limited to less than half of the transition portion, which may be approximately ring-shaped.

[0038] Depending on the configuration, the patient interface, or the sealing configuration of the patient interface, comprises a first and second outlet for supplying respiratory gas from an internal cavity to the user's nostrils. A nasal locator or sealing member (e.g., a nasal pillow) is associated with and forms a portion of each outlet. A flexure region is defined within the annular transition portion between each nasal locator or sealing member and the surrounding portion of the sealing configuration. The flexure region has lower stiffness than other regions of the transition portion that are not within the flexure region. Lower stiffness may be achieved by reducing the wall thickness within the flexure region compared to other regions. The flexure region may be located outside the nasal locator or sealing member to facilitate outward tilting. The flexure region may be limited to about half or less of the annular transition portion, which may be substantially annular in shape.

[0039] Depending on the configuration, the sealing member may be provided on the mask having any set or subset of the features described herein, or any combination of the set or subset of features. In some such configurations, the mask may have such sealing member.

[0040] Depending on the configuration, the sealing member comprises a proximal and a distal surface. The proximal surface has one or more outlets for supplying breathing gas to the patient. The proximal and distal surfaces define an internal cavity within the sealing member. At least one integrated support structure is located below at least a portion of the internal cavity.

[0041] In some such configurations, at least one integrated support structure comprises a crescent-shaped member that is structurally integrated with the sealing member.

[0042] In some such configurations, at least one integrated support structure extends at least partially upward along at least a portion of the distal plane. In some such configurations, at least one integrated support structure extends upward along the distal plane. In some such configurations, a portion of at least one integrated support structure extending upward along the distal plane extends proximal and is configured to support the user's area along the cheek region.

[0043] In some such configurations, a portion of the integrated support structure beneath the internal cavity extends proximal to support the user's area directly above the lips.

[0044] In some such configurations, the integrated support structure comprises one or more thickened regions of the sealing member. In some such configurations, the thickened region incorporates a hollow region having another material positioned within the hollow region of the integrated support structure.

[0045] In some such configurations, at least one integrated support structure is positioned within an edge surface connecting the proximal surface to the distal surface. In some such configurations, the edge surface is wider at the bottom than at the top. In some such configurations, the sealing member has a wall that is thicker in the region including the bottom of the edge surface than in the region substantially surrounding one or more discharge ports. In some such configurations, the region with the thicker wall extends upward from the bottom of the edge surface.

[0046] In some such configurations, at least one integrated support structure is positioned within the widest lateral region of the sealing member.

[0047] In some such configurations, at least one integrated support structure extends to the most proximal of any other part of the sealing member.

[0048] In some such configurations, at least one integrated support structure is positioned within the widest lateral region of the sealing member and extends to the most proximal of any other portion of the sealing member.

[0049] Various features, embodiments, and advantages of the present invention can be implemented in any of the following ways. For example, several embodiments are described herein, and any set or subset of features of any embodiment may be used together with any set or subset of features of any other embodiment.

[0050] The term “comprising” is used herein and in the claims to mean “consisting of at least a part of.” When interpreting any description herein and in the claims that includes “comprising,” other features or features beginning with this term may also exist. Related terms such as “comprise” and “comprises” should be interpreted similarly.

[0051] Where this specification references patent specifications, other external documents, or other sources of information, such references are generally intended to provide background for describing the features of the invention. Unless otherwise specified, references to such external documents should not be construed in any way as an admission that such documents or sources of information constitute prior art or form part of the common general knowledge in the art.

[0052] These and other features, embodiments, and advantages of the present invention will be described with reference to the following drawings. [Brief explanation of the drawing]

[0053] [Figure 1] This is a front view of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 2] Figure 1 is a side view of the interface assembly. [Figure 3] Figure 1 is a rear view of the interface assembly. [Figure 4] This figure shows a user wearing an interface assembly that has specific characteristics common to the interface assembly in Figure 1. [Figure 5] This is a partial exploded view of a portion of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 6] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 7] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 8] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 9A] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 9B] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 9C] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 9D] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 9E] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 9F] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 10] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 11] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 12] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 13] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 14A] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 14B] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 14C] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 14D] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 15A] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 15B] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 15C] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 15D] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 16] This is a rear view of a portion of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 17] Figure 16 is a bottom view of a portion of the interface assembly. [Figure 18]Figure 16 is a perspective view of a portion of the interface assembly. [Figure 19] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 20A] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 20B] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 20C] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 20D] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 20E] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 21] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 22] This figure shows a portion of the nasal cavity, as well as a portion of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 23A] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 23B] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 23C] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 24] This is a partial diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 25A]This figure shows an interface assembly of the prior art, as well as an interface assembly arranged and configured according to specific features, aspects, and advantages of the present invention. [Figure 25B] This figure shows an interface assembly of the prior art, as well as an interface assembly arranged and configured according to specific features, aspects, and advantages of the present invention. [Figure 26] This is a diagram of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 27] This is a diagram of another interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 28] This is a diagram of another interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 29] This is a partially exploded perspective view of an interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Figure 30] Figure 29 is a more completely disassembled perspective view of the interface assembly. [Figure 31] Figure 29 is a perspective view of the interface assembly. [Figure 32] This is a cross-sectional view along line AA in Figure 31. [Figure 33] Figure 32 is a cross-sectional view along line BB. [Figure 34] This is a magnified view of a portion of Figure 33. [Figure 35] This is a diagram of the sealing member in the interface assembly shown in Figure 29, indicating the material thickness of the proximal wall. [Figure 36] This is a diagram of the sealing member in the interface assembly shown in Figure 29, indicating the material thickness of the proximal wall. [Figure 37] This is a diagram of the sealing member in the interface assembly shown in Figure 29, indicating the material thickness of the proximal wall. [Figure 38] This is a diagram of a sealing member showing the material thickness of the distal wall. [Figure 39]This is a diagram of a sealing member showing the material thickness of the distal wall. [Figure 40] This is a diagram of a sealing member showing the material thickness of the distal wall. [Figure 41] Figure 33 is an enlarged view of a portion of the cross-section of the sealing member shown. [Figure 42] Figure 29 is a rear view of the sealing member in the interface assembly. [Figure 43] This is a cross-sectional view of another interface assembly arranged and configured according to specific features, embodiments, and advantages of the present invention. [Modes for carrying out the invention]

[0054] Figure 1 shows a patient interface 100 arranged and configured according to specific features, embodiments, and advantages of the present invention. Interface 100 can be used to supply pressurized respiratory gas to a recipient. Interface 100 is well suited to providing respiratory gas to a recipient in situations where significant pressure changes may occur. For example, but not limited to, Interface 100 can be used to deliver continuous positive airway pressure (CPAP).

[0055] Continuing to refer to Figure 1, the interface 100 is shown separated from the patient who will wear the interface 100. Several embodiments of the patient interface 100 and variations thereof are 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 comprises a mask 102. Depending on the configuration, a strap 104 can be attached to the mask 102 and used to secure the mask 102 to the patient. Depending on the configuration, the interface 100 also comprises a flexible supply conduit 106 which can be connected to the mask 102.

[0056] Continuing to refer to Figure 1, and further to Figure 2, the mask 102 is configured to fit over or cover both of the patient's nostrils. Depending on the configuration, the mask 102 may include lateral portions 110 (see Figure 2) configured to curve toward each lateral side of the patient's nose. These lateral portions 110 can form a perimeter seal on the outward-facing surfaces of the sides of the nose. The strap 104 may wrap around the user's head in a simple loop over the user's ears.

[0057] The flexible conduit 106 may hang down from the central connector 112. Depending on the configuration, the central connector 112 may be positioned on the front portion of the mask 102. Preferably, the central connector 112 is equipped with a swivel elbow. The elbow allows the flexible conduit 106 to pivot relative to the mask 102. By enabling pivoting, the elbow can help the interface 100 better adapt to the patient's sleeping position. Depending on the configuration, the central connector 112 may be equipped with a ball joint so that the elbow can pivot around axes parallel and perpendicular to its connection with the mask 102.

[0058] The illustrated mask 102 generally comprises a seal 114 and a body or frame 116. The seal 114 and frame 116 can be connected in any suitable manner.

[0059] The seal 114 preferably defines a flexible pocket or cover that may include a recessed area. Depending on the configuration, the seal 114 may have a thin wall thickness and can be formed from any suitable material. For example, but not limited to, the seal 114 may be formed from latex, vinyl, silicone, or polyurethane. Depending on the configuration, the wall thickness may be less than about 0.5 mm, and depending on the area and configuration, it may be less than about 0.2 mm. Depending on the configuration, the seal 114 may be formed from a material having sufficient elasticity and yield strength, and as a result, the combination of elasticity and yield strength makes the seal 114 flexible. The seal 114 preferably can withstand repeated significant deformation without breaking.

[0060] Referring to Figure 3, the seal 114 preferably comprises one or two nostril locators 120. The nostril locators 120 may protrude from the seal 114. Depending on the configuration, the nostril locators extend substantially upward and posteriorly from the proximal wall 124 of the seal 114. Depending on the configuration, the nostril locators 120 extend substantially posteriorly from the proximal wall 124 of the seal 114.

[0061] In the configurations shown in Figures 1 to 3, the nostril locator 120 is formed integrally with the seal 114 (i.e., as a single piece). Each nostril locator 120 may be equipped with an exit aperture 118 through which gas can be supplied from the flexible conduit 106. Depending on the configuration, the gas can be supplied from within a pocket or covering defined by the seal 114. In other configurations, the supplied gas can be separated from the gas supplied to the pocket or covering defined by the seal 114.

[0062] The seal 114 generally comprises a distal wall 122 and a proximal wall 124. The outer surface of the distal wall 122 preferably faces away from the user, and the outer surface of the proximal wall 124 preferably faces the user. The edge 126 (see Figures 1 and 2) can connect the outer periphery of the distal wall 122 and the outer periphery of the proximal wall 124. The cover or pocket described above can be defined within at least the distal wall 122 and the proximal wall 124.

[0063] The seal 114 is preferably designed to wrap around the tip or lower part of the user's nose (for example, below the bridge of the nose). Therefore, the illustrated seal 114 includes a central portion 128 (see Figure 1) positioned between the lateral portions or wings 130. The central portion 128 may be below the user's nose and preferably incorporates a nostril locator 120. Depending on the configuration, the central portion 128 may extend above the tip of the user's nose. In other configurations, the central portion 128 does not extend above the tip of the user's nose. The wings 130 can form at least a portion of the lateral portions 110 described above. The wings 130 may be configured to extend completely or substantially completely over the sides of the user's nose and may extend at least partially over the user's cheeks.

[0064] As described above, at least a substantial portion of the seal 114 may be flexible. For example, the area surrounding the nostril locator 120 may be more flexible than at least a portion of the wing 130. At least the proximal wall 124 and the edges 126 of each lateral portion may be very flexible so that they can expand to conform to the contour of the user's face, particularly the contour of the outer flank of the user's nose. The flexible portion of the seal 114 is preferably of sufficient size and shape to conform to the surface of the user's face (i.e., along at least the sides of the nose and at least a portion of the upper lip) when the expanded seal is pressed against the user's face with the nostril locator 120 engaged in the user's nostril.

[0065] However, to improve the shape, fit, and function of the mask 102, selected portions of the seal 114 can have high rigidity. For example, at least a portion of the edge 126 can be made significantly stiffer to control bulging in other areas of the seal 114. Furthermore, the region adjacent to and including the inlet opening of the seal 114 (e.g., the portion receiving the gas flow from the conduit 106) can have lower flexibility. Thus, the distal wall 122 may have lower flexibility from the wing 130 to the central portion including the inlet opening. The less flexible region can be formed from a different material, or from the same material but with greater thickness.

[0066] As described above, the frame 116 supports the seal 114. Depending on the configuration, the inlet opening of the seal 114 can be attached to the frame 116, and the flexible conduit 106 can also be attached to the frame 116, thereby allowing gas to be supplied to the seal 114 via the frame 116. In other configurations, the seal 114 is directly connected to the flexible conduit 106. Depending on the configuration, the seal 114 can be connected to the conduit 106 at a central connector 112.

[0067] The frame 116 may have any suitable configuration for securing the seal 114. Depending on the configuration, an annular wall may extend from the proximal side of the frame 116 around an opening that extends to the connector 112. The annular wall may include an outwardly extending lip portion. The inlet opening of the seal 114 can engage from above with the outwardly extending lip portion of the annular wall. Depending on the configuration, the inlet opening of the seal 114 may be extended to fit into the annular wall. The inlet opening of the seal 114 may have, for example, but not limited to, a thickened or reinforced wall section. Depending on the configuration, the extended portion of the seal 114 may be wrapped up on the annular wall of the frame 116. In another configuration, the seal 114 may be provided with a part of the connector, and at least one of the frame 116 and the conduit 106 may include a complementary connector portion.

[0068] The frame 116 can be designed to have minimal dimensions. Advantageously, reducing the dimensions of the frame 116 allows for a clearer field of vision for the user, enabling the user to wear glasses while wearing the interface 100. The frame 116 is preferably formed from an elastomer material, thereby allowing the frame 116 to bend slightly to fit the user's face. However, the frame 116 supports the seal 114. Supporting the seal 114 allows the seal to be pressed more effectively against the user's face and around the nose. The frame 116 can be formed by injection molding, preferably from an elastomer material such as silicone or polyurethane, for example, but not limited to. Depending on the configuration, the frame 116 can be formed from a more rigid material such as polycarbonate, polyester polystyrene, or nylon, for example, but not limited to.

[0069] During use, the flexible proximal wall portions 124 on the top, bottom, and sides of the nostril locator 124 expand due to the pressure inside the seal 114 (e.g., from the flow of gas supplied to the patient interface 100), pressing against the user's skin to conform to the contour of the outer surface of the user's nose, the lower surface of the user's nose, and the surface of the user's upper lip directly below the nose. The flexibility of the periphery or surrounding area of ​​the seal 114 allows the mask 102 to move in any direction (except directly away from the face) to a small extent, so that even if the mask 102 moves, this seal with the face is not significantly damaged. The flexible portion of the seal 114 somewhat separates the position of the nostril locator 120 from the position of the mask 102, and this separation allows the mask 102 to be displaced to some extent in at least one or both of the lateral and vertical directions (i.e., lateral and perpendicular to the axis of the patient's face). The wings 130 engage with the sides of the user's nose, further forming a seal. The Wing 130 also supports the mask's position.

[0070] Referring to Figure 4, when wearing the interface 100, the mask 102 can be opened by spreading the wings 130 and increasing the angle between the wings 130. When the wings 130 are pulled open, the nostril locators 120 (see Figure 3), positioned on the proximal wall 124, are better positioned toward the user and guide the mask 102 to the user's face. Once the nostril locators 120 are properly positioned, the mask 102 can be secured in place with the straps 104, which form loops around the user's head vertically above the ears. Other techniques for wearing the interface can also be used.

[0071] As described above, when wearing the interface 100, it is preferable to fold or unfold the seal 114 to improve the fit and help achieve the desired positioning. However, in the configurations shown in Figures 1 to 4, unfolding the seal 114 generally requires positioning a finger between the seal 114 and the user's face, which can be cumbersome for the user. Furthermore, it can be difficult to open the seal 114 with one hand and bring the strap 104 into place with the other hand.

[0072] Referring to Figure 5, an interface 100a with a seal operation assembly 140 is shown. For clarity, the lower frame 116a in Figure 5 has been removed, and the seal 114a of the interface 100a connected to the upper frame 116a in Figure 5 is shown in magnified view. The seal operation assembly 140 preferably comprises a pair of pads 142. The pads 142 extend outward from the seal 114a. Depending on the configuration, the pads 142 are positioned along the distal surface 122a. Depending on the configuration, the pads 142 extend outward from the distal surface 122a. Depending on the configuration, the pads 142 are formed integrally with the seal 114a. Depending on the configuration, the pads 142 are a separate component from the seal 114a. In the illustrated configuration, the frame 116a of the interface 100a includes a recess 144 that receives at least a portion of the pads 142. The seal 114a is located beneath the frame 116a in the area of ​​the pad 142. Depending on the configuration, the seal 114a is not fixed to the frame 116a in or near the area of ​​the pad 142, so that the seal 114a can move relative to the frame 116a.

[0073] The pad 142 is connected to the actuation mechanism of the seal operation assembly 140. Depending on the configuration, the pad 142 is connected to a scissor arm extending into the seal 114a. The scissor arms can be crossed and hinged together so that the ends 146 of the seal 114a can move away from each other by firmly gripping the pads 142 toward each other.

[0074] Depending on the configuration, the operating mechanism may be simpler than the scissor mechanism described above. For example, referring to Figure 6, a simplified diagram of the operating mechanism, the pad 142 is connected to or integrally formed with the arm 150. The arm may extend toward the end 146 of the seal 114a. The length of the arm 150 may be longer than the length of the pad 142. The front portions of the arm 150 can be held apart from each other using a cross member 152. Depending on the configuration, the material of the seal 114a, the frame 116a, or a combination of the seal 114a and the frame 116a may be stiff enough to separate or spread both ends 146 of the seal 114a by operating the pad 142 without including the cross member 152. By holding the arm 150 apart between the pad 142 and the end 146, the pad 142 is pressed toward each other, causing the ends 146 to move away from each other. Depending on the configuration, the arm 150 can be connected to the flexible cross member by an active hinge, by a rigid connection to an elastically deformable cross member, or by a pin joint or the like.

[0075] By manipulating the shape of the uninflated seal 114a (for example, by separating the ends 146a to change how the seal 114a initially appears to the user), the seal 114a is opened to be positioned on the user's face. Once positioned, the seal 114a can be inflated, causing it to expand around the user's nostrils.

[0076] Referring now to Figure 7, another seal 114b is illustrated. Seal 114b is provided with another seal operation configuration 140b. In the illustrated seal 114b, the seal operation configuration 140b can be attached to a portion of the distal wall 122b or formed integrally with it. Preferably, the seal operation configuration 140b is positioned along the distal wall 122b along the lateral portion 110b or the wing 130b.

[0077] The sealing operation configuration 140b can take any suitable configuration. Depending on the configuration, for example, but not limited to, the sealing operation configuration 140b may include a wall 154 that can define a loop of material into which a finger can be inserted. In the illustrated configuration, the sealing operation configuration 140b includes pockets 156. Each pocket 156 may have a rim 160 at its distal end. The rim 160 may define an opening large enough to receive the tip of a finger. The proximal end of each pocket 156 may be closed or left open. In the illustrated configuration, the proximal end of each pocket 156 is closed.

[0078] Depending on the configuration, the surface feature portion 158 may be provided adjacent to the opening defined by the edge portion 160. The surface feature portion 158 may be a recess or a surface texture. The surface feature portion 158 may be positioned just in front of the opening to guide a finger to a desired position. The surface feature portion 158 may be provided with additional clearance to facilitate finger insertion.

[0079] By positioning pocket 156 on the outside of seal 114b, a finger can be inserted into pocket 156, and using pocket 156 to apply outward force to wing 130b, the seal 114b can be opened so that it is exposed to the face.

[0080] Referring here to Figure 8, the mask 102c may have a seal 114c featuring an integrated arm 170. In the illustrated configuration, the arm 170 can extend along the outer portion of the distal wall 122c. Integrating the arm 170 into the seal 114c eliminates the need for the frame 116, which can be directly integrated into the seal 114c or remain a separate support element. When integrated into the seal 114c, the mask frame 116 can be defined by areas of increased rigidity (i.e., areas of less flexibility). For example, when integrated into the seal 114c, the feature portion of the mask frame 116 can be replaced by areas of increased thickness or overmolded characteristics.

[0081] In the illustrated configuration, the integrated arm 170 extends from the distal region of the distal wall 122c to the proximal region. It is preferable that each end 146c be separated from the associated arm 170 so that the end 146c can move without the overlapping portion of the arm 170 moving significantly. That is, the connection between the arm 170 and the distal wall 122c may terminate distally at the end 146c so that at least a portion of the arm 170 overlaps but does not directly connect to the proximal end of the distal opposing wall 122c.

[0082] In the illustrated configuration, the mounting member 172 can be formed at the proximal end of each arm 170. The mounting member 172 can have any suitable configuration and can be used to connect the arms 170 to a strap (not shown) or other headgear assembly. In the illustrated configuration, the mounting member 172 comprises a post 174 positioned within a recess 175. The strap or other headgear can be wrapped around the post 174, or secured to the post 174 with a hook member, for example, but not limited to.

[0083] Figures 9A to 9F show seals 114d having different surface textures along at least a portion of the proximal wall 124d. The surface texture can be positioned along at least any portion of the proximal wall 124d. Depending on the configuration, the surface texture can be positioned along the proximal portion of the proximal wall 124d. Depending on the configuration, the surface texture is simply positioned along the proximal portion of the proximal wall. Depending on the configuration, the surface texture can be positioned on other surfaces, but relative to the proximal wall 124d, the surface texture is simply positioned proximal to any nostril locator 120d.

[0084] Figures 9A to 9F show the surface textures of the slot 176, recess 180, scallop shell 182, plateau 184, and rib 186. Any other suitable surface texture, including shapes, recesses, and protrusions, can be provided on the proximal wall 124d of the seal 114d. Depending on the configuration, combinations of surface textures, including but not limited to those described herein, may be used.

[0085] Depending on the configuration, the textured portion may be positioned outside the nostril locator 120d. Depending on the configuration, the textured portion may be positioned completely outside the nostril locator 120d. Depending on the configuration, the textured portion may be positioned surrounding, partially surrounding, or substantially adjacent to the nostril locator 120d. In such positions, the textured portion can reduce the contact area with the user's skin while still maintaining sufficient sealing to the user's face. By reducing the contact area between the user's face and the seal 114d, the user perceives the contact area as cooler. Depending on the configuration, since other areas in addition to the area with the textured surface define the first seal with the face, the textured surface can improve comfort without significantly degrading the seal existing between the seal 114d and the face.

[0086] The interfaces shown in Figures 1 to 4 are structures that incorporate both the seal 114 and the nasal locator 120 into a single component. Referring here to Figures 10 to 12, the interface can also include a mask with a detachable nasal locator and seal. By making the seal and one or more of the nasal locators detachable, the mask can be better adapted for use by users with different facial shapes. For example, the dimensions may differ depending on the detachable components. Depending on the configuration, the inflation seal may be common, and the nasal locators may be interchangeable according to the dimensions desired by the user. Depending on the configuration, the seal may be provided in different shapes, such as, for example, a wide version and a narrow version.

[0087] Referring here to Figure 10, the illustrated interface 100e comprises a seal 114e with a separable nose insert 190 and a sealing member 192. The seal 114e is formed from two or more components, but if not, the seal 114e can be constructed in substantially the same manner as the seal 114 shown in Figures 1 to 4 and described above. For example, the seal 114e can be composed of a more flexible region and a less flexible region, similar to the seal disclosed above.

[0088] The nasal insert 190 includes at least one nostril locator 194. The nostril locator 194 may be located at the top of the body 196. In the illustrated configuration, two nostril locators 194 are integrally formed with the body 196. Depending on the configuration, the two nostril locators 194 may be separable from the body 196.

[0089] The main body 196 includes a plug portion 200, and the sealing member 192 includes a receptacle portion 202. The plug portion 200 can be received within the receptacle portion 202 as shown by the arrow in Figure 10. Depending on the configuration, the plug portion 200 may be fixed in place within the receptacle portion 202. Depending on the configuration, the plug portion 200 may be fixed within the receptacle portion 202 by friction fitting. Other suitable techniques may also be used to fix the plug portion 200 and the receptacle portion 202.

[0090] The distal end 204 of the main body 196 has an inlet opening, and proximal to the inlet opening, the main body 196 has one or more openings 206. The inlet opening can be connected to a flexible supply conduit 106. The sealing member 192 has one or more internal voids or openings 208, and when the plug portion 200 is positioned within the receiving portion 202, one or more internal voids or openings 208 can be in fluid communication with one or more openings 206. Thus, in the configuration of Figure 10, gas flows from the flexible conduit to the nasal insert 190, some of the gas flows from the nasal insert 190 to the sealing member 192, and some of the gas flows from the nasal insert 190 through the nasal locator 194 to the user.

[0091] Referring to Figure 11, the nasal insert 190a and the sealing member 192a can be joined together to define the mask. The nasal insert 190a may have an inlet in a plug portion 200a located at the distal end of the nasal insert 190a. The inlet can be formed by the plug portion 200a. However, the sealing member 192a may have a distal inlet (not shown) that connects directly to the supply conduit (i.e., connects to the supply conduit rather than receiving flow from the nasal insert 190a), and an outlet that connects to the nasal insert 190a. The nasal insert 190a may include, but is not required, an opening used in the configuration of Figure 10. Thus, in the configuration shown in Figure 11, the gas is first supplied to the sealing member 192a, which then delivers the gas to the nasal insert 190a through the inlet at the distal end of the nasal insert 190a, and then the nasal insert 190a delivers the gas from the nasal insert 190a to the nostril locator 194a.

[0092] A further multi-piece seal structure is described here with reference to Figure 12. The multi-piece structure allows the seal to be customized to the user. For example, nostril locators of different dimensions can be used with a common seal member or a seal member of different dimensions. Furthermore, nostril locators of different hardness or rigidity can be used, and / or seal members of different hardness levels can be used. Depending on the configuration, the seal member and nostril locator can be formed from the same material. Depending on the configuration, the seal member and nostril locator can be formed from the same material but of different grades.

[0093] The sealing member 192b shown in Figure 12 comprises one or more outlet openings 208 formed on its proximal surface. In the illustrated configuration, the sealing member 192b comprises two openings 208 that receive individual nostril locators 210. The openings 208 can define a receiving port, and the distal end 212 of the nostril locator 210 can define a plug. As shown in Figure 12, the distal end 212 fits into the opening 208. The nostril locators 210 can be connected to the sealing member 192b in any suitable way. Depending on the configuration, the nostril locators 210 can be friction-fitted into the openings 208. Depending on the configuration, the distal end 212 and the openings 208 can be configured to connect in a single rotational direction. Depending on the configuration, the rotational direction can be varied to customize the fit of the nostril locator 210. Depending on the configuration, the relative rotational direction of the opening 208 and the nostril locator 210 may be indexable so that they can be rotated and fixed at a desired rotational position.

[0094] Referring here to Figure 13, a seal 214 is shown, featuring a separable nasal insert 216 and a sealing member 218. The seal 214 may resemble any of the configurations described above. However, in some configurations, the nasal insert 216 includes an auxiliary component 220. As shown in Figure 10, the auxiliary component 220 can be positioned between one or more nostril locators 222 and the base 224 of the nasal insert 216. In some configurations, a rim 230 can surround one or more nostril 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 one or more nostril locators 222 and the auxiliary component 220. In the illustrated configurations, the base 224 of the nasal insert 216 may, but is not required, have one or more openings 226.

[0095] 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 nasal insert 216. The opening 228 and the auxiliary component 220 are flexible enough to allow the auxiliary component 220 of the nasal insert 216 to be inserted into a pocket defined within the wall of the sealing member 218. Depending on the configuration, the opening 228 seals around a portion of the nasal insert 216 between the auxiliary component 220 and the edge 230.

[0096] The edge portion 230 and the auxiliary component 220 can be separated by, for example, but not limited to, a gap, recess, channel, or groove. The sealing member 218 may include a lip portion that fits into a gap, recess, channel, or groove that can be defined between the edge portion 230 and at least a portion of the auxiliary component 220. That is, the auxiliary component 220 can overhang at least a portion of the edge portion 230 and be separated from it. The gap between the auxiliary component 220 and the edge portion 230 can be dimensioned and configured to receive the smallest portion of the seal 214. In this way, the sealing member 218 and the nose insert 216 can be fixed together, for example, but not limited to. Furthermore, in the illustrated configuration, the sealing member 218 and the nose insert 216 can be sealed together.

[0097] Here, with reference to Figures 14A to 14D, sampling in auxiliary components of different structures is described. The nasal insert 216a is shown in Figure 14A, and the auxiliary component 220a comprises a slightly curved blade member 232. The blade member 232 extends laterally outward beyond the nostril locator 222a and laterally outward beyond the outermost extent of the edge 230a that substantially surrounds the nostril locator 222a. The blade member 232 can be formed integrally with the nasal insert 216a, or it can be formed separately from the nasal insert 216a and fixed to the nasal insert 216a in any suitable manner. Depending on the configuration, the blade member 232 is formed from silicone. The blade member 232 may be an elastic member that can bend to a first position and a second position. Depending on the configuration, the blade member 232 may be a member that is stable in two directions; that is, the blade member 232 may take on two distinct positions that have sufficient stability to remain in those positions at least temporarily. Depending on the configuration, when the associated sealing member 218a is under-expanded or does not expand at all, the blade member 232 has sufficient restoring force to assume a first shape or position. Depending on the configuration, when the associated sealing member 218a expands for use, the blade member 232 bends or flexes. Such a configuration is shown in Figure 14A, where the outermost portion of the blade member 232 is flexed upward.

[0098] As shown in Figure 14A, the blade member 232 is provided with additional material that contacts one or more inner surfaces of the sealing member. The blade member 232 may be configured to assist in attaching the mask to the user's face by pressing the sealing member 218a to an open position and flexing while the user is using the interface. By slightly opening the mask, the nostril locator 222a can more easily engage with the nostrils. When gas pressure is supplied to the sealing member 218a, the sealing member expands and inflates, sealing and engaging with the user's face. Preferably, the blade member 232 is flexible enough to bend and conform to the shape of the sealing member 218a so that when the sealing member 218a begins to expand, the sealing member 218a can expand and seal around the user's nose.

[0099] Figure 14B shows a nasal insert 216b that is similar in several respects to the nasal insert 216a shown in Figure 14A. The edge 230b of the nasal insert 216b in Figure 14B is provided with a loop member 234. The loop member 234 is similar in several respects to the blade member 232. However, the loop member 234 extends both proximal and distally, as well as laterally outward. That is, as is evident from comparing Figure 14A with Figure 14B, the blade member 232 is a substantially flat, dish-shaped component in Figure 14A, while the loop member 234 is not as flat and extends both anteriorly and posteriorly. Therefore, the loop member 234 makes the proximal portion of the associated seal member 218b easier to operate, as well as the distal portion of the seal member 218b. In other words, the blade member 232 may contact the inner surface of the distal portion of the sealing member, and the loop member 234 may contact the inner surfaces of the proximal and distal portions of the sealing member 218b.

[0100] Continuing to refer to Figure 14B, the loop member 234 extends laterally outward from the nostril locator 222b and beyond the outermost extent of the edge 230b. The loop member 234 can be formed integrally with the nasal insert 216b, or it can be formed separately from the nasal insert 216b and fixed to the nasal insert 216b in any suitable manner. Depending on the configuration, the loop member 234 can be formed from silicone.

[0101] By contacting the inner surface of the sealing member 218b, the loop member 234 positions the sealing member 218b in the open position before it expands, giving the deflated sealing member 218b an initial shape. When gas pressure is supplied to the sealing member 218b, the sealing member 218b expands and inflates, sealing and engaging with the user's face. Preferably, the loop member 234 is flexible enough to bend and conform to the shape of the sealing member 218b so that when the sealing member 218b begins to expand, the sealing member 218b can expand and seal around the user's nose. Depending on the configuration, the loop member 234 can switch between two positions. Depending on the configuration, the loop member 234 can be configured to easily flex from the open position or the first position when the seal expands, but return to the open position or the first position when the seal deflates again.

[0102] Figure 14C shows a nose insert 216c having an inflatable auxiliary component 220c. The auxiliary component 220c comprises one or more stabilizers 236. The stabilizer 236 may have one or more outer walls and may be inflatable. Thus, an inner pocket defined within the stabilizer 236 can communicate with a gas source, such as a flow through the associated sealing member 218c. In the illustrated configuration, the stabilizer 236 can be connected to the base 224c of the nose insert 216c. The inflatable stabilizer 236 can provide a force that presses the proximal surface of the sealing member toward the user's face when under operating pressure. Thus, unlike the loop member 234 and the blade member 232, the inflatable stabilizer 236 does not serve to hold the uninflated mask in the open position. The stabilizer 236 provides improved sealing force during use.

[0103] Referring to Figure 14D, a nose insert 216d is shown with an auxiliary component 220d that can be bent between a first position P1 and a second position P2. The auxiliary component 220d may include a dish member 238 that is stable in the first position P1 and the second position P2. Depending on the configuration, the dish member 238 can be inverted between the first position P1 and the second position P2, but can be returned to the first position P1 with minimal force. As shown in Figure 14D, the dish member 238 can be bent to the second position P2 for wearing the mask. With the dish member 238 in the second position P2, the sealing member 218d can be held in an open position. When positioned on the user as needed, the dish member 238 can be quickly returned to the first position P1 by slightly pressing it towards the user's face, thereby moving the sealing member 218d to a more closed position.

[0104] Therefore, to wear a mask with the assembly shown in Figure 14D, the dish member 238 can be bent from a first position P1 to a second position P2. When the mask is positioned so that the nasal locator 222d can be positioned within the user's nostrils, the dish member 238 is temporarily stable in the second position. When the mask engages with the user's face, the force is transmitted to the dish member 238 via the sealing member 218d, causing the dish member 238 to immediately return to its original position or to the first position P1. With the dish member 238 in the first position, the sealing member 218d can surround the tip of the user's nose, thereby allowing the mask with the assembly shown in Figure 17 to seal around the tip of the user's nose.

[0105] Referring here to Figure 15A, a portion of the sealing member 250 is shown. The sealing member 250 can be configured according to any combination of any of the structural features described herein, for example, but not limited to. The sealing member 250 may comprise a distal wall 252 and a proximal wall 254. The opening 256 may be defined within the distal wall 252. A gas supply can enter the sealing member 250 through the opening 256.

[0106] As shown in Figure 18, the distal wall 252 may have a thicker cross-section than, for example, the proximal wall 254. A thicker cross-section gives the distal wall 252 higher rigidity than the proximal wall 254. Depending on the configuration, the material used may have high rigidity, but the wall thickness may be the same. Depending on the configuration, both the thickness and rigidity of the material can be used to provide different degrees of rigidity.

[0107] In the configuration shown in Figure 15A, the nostril locator 260 can be positioned along the proximal wall 254. The illustrated nostril locator 260 can generally taper towards the proximal opening 262. Therefore, the proximal opening 262 may have a smaller diameter than the distal opening into the nostril locator 260. Generally, the nostril locator 260 can taper in the proximal direction.

[0108] Outriggers or other support structures can be used to improve the lateral stability of the mask assembly. However, the configurations shown in Figures 15A to 15D show a support structure integrated into the structure of the sealing member 250 itself. Referring to Figures 15A to 15C, a support structure 270 integrated into the sealing member 250 is shown. With the integrated support structure 270, the mask is more comfortable than other masks that may use a separate support structure that is more rigid than the sealing member. Furthermore, because the support structure 270 can be directly adjacent to the user's face, the integrated design allows for better support of the sealing member 250.

[0109] The illustrated support structure 270 may be one or more thickness regions. For example, if the sealing member 250 is formed from silicone, the support structure 270 may be a thickness region of silicone. In some such configurations, the support structure 270 can be molded into the sealing member 250. Depending on the configuration, foam may be injected or inserted into the support structure 270. For example, in some such configurations, the support structure 270 may be formed as a hollow region (or material may be removed), and this region may be filled with any desired gel-like or foamy substance. Depending on the configuration, the support structure 270 may be formed from silicone, and the hollow region may be filled with different grades of silicone. Such composite support structures can reduce the weight of the seal and mask assembly.

[0110] By molding the support structure 270 into the sealing member 250, the support structure can be bent within the sealing member 250. By bending the sealing member 250, it can better conform to different facial shapes. Furthermore, the support structure 270 can move together with the sealing member 250, allowing the sealing member 250 to be positioned closer to the face. Moreover, by incorporating the support structure 270 into the sealing member 250, the support structure is not formed separately or by an overmolding process, thus simplifying the manufacturing of the mask. Furthermore, this incorporation reduces the weight of the assembly and makes it easier to reduce its dimensions.

[0111] Referring to Figures 15A to 15C, the illustrated support structure 270 is a crescent-shaped member located approximately below the sealing member 250. Referring to Figure 15D, depending on the configuration, the support structure 270 can wrap upward along one or more of the outer (distal) side walls 252. Thus, as illustrated, the support structure 270 can be provided in various shapes. Since the support structure 270 can be molded as a single unit, the shape of the support structure 270 can always be adjusted to support the sealing member 250 if necessary. The configurations in Figures 15A to 15C show a structure that supports directly above the user's lip area, while the configuration in Figure 15D repositions the support above the lip, in the cheek area, excluding the fairly narrow area below the nose. Thus, in the configuration in Figure 15D, the support moves outward toward the cheek, away from the upper lip. In some configurations similar to that shown in Figure 15D, even when the support structure 270 wraps around the side wall vertically upward, the support remains approximately the lower half of the sealing member 250. By changing the position of the support structure 270, the comfort of the sealing member 250 can be improved, as can the performance of the sealing member 250.

[0112] Referring here to Figures 16-18, another mask sealing member 280 is shown. The mask sealing member 280 comprises a distal wall 282 and a proximal wall 284. One or more nostril locators 286 can be positioned on at least a portion of the proximal wall 284. The nostril locators 286 can have any suitable configuration. Depending on the configuration, the nostril locators 286 taper upward to an opening 288.

[0113] As shown in Figure 17, the proximal wall 284 wraps proximal to the nostril locator 286. Furthermore, the illustrated nostril locator 286 extends to a portion of the proximal wall substantially perpendicular to the vertical bisecting plane P, as well as to a portion of the proximal wall 284 that wraps proximal to it. Other configurations are possible. In the illustrated configuration, the proximal wall 284 extends proximal to most of the proximal portion of the nostril locator 286. Since the sealing member 280 has a laterally extending portion 290 that wraps proximal to it, the laterally extending portion 290 may hold the nostril locator away from the nostrils of a flatter user face shape. To help provide improved flexibility, the sealing member 280 can be reinforced in the region closer to the nose compared to the cheek.

[0114] Referring to Figure 16, the sealing member 280 may have an edge surface 292 connecting the proximal wall 284 to the distal wall 282. In the illustrated configuration, the edge surface 292 is wider at the bottom than at the top. As shown, the edge surface can provide a wider bottom to the illustrated sealing member 280. The sealing member 280 may have a thicker wall at the bottom corner, and the proximal wall 284 may be thinner in the area surrounding, or at least partially surrounding, the nostril locator 286. The thicker area at the bottom corner may extend upward and follow a substantially vertical line as shown in Figure 15.

[0115] The sealing member 280 can be configured to bulge over the majority of the entire structure, with thicker areas bulging less than thinner areas. The thicker areas can help control the bulging, resulting in the proximal surface receiving most of the bulging compared to the edge surface 292 and distal surface 282. Thus, the area surrounding the nostril locator 286 can bulge more, while the bottom corners bulge less, which increases comfort and improves the sealing performance of the mask.

[0116] Referring again to Figure 3, the nasal locator 120 is typically configured to be positioned within the nostril. The nasal locator 120 can be made stiff enough to resist crushing while fitted and in use in order to fit within the user's nostril. As such, the proximal end of the nasal locator 120 has been found to slightly pinch the septum or reduce user comfort. Therefore, it may be desirable to reduce some of the stiffness of the nasal locator 120, particularly the proximal end of the nasal locator 120, and / or the stiffness of the transitional position between the nasal locator 120 and the surrounding structure (see Figures 29 to 42, described later).

[0117] Referring now to Figure 19, a cross-section of the sealing member 300 is shown. A nostril locator 302 extending from the proximal surface 304 is shown. The nostril locator 302 may include an opening 306. In the illustrated configuration, the opening 306 can be defined by a rim 308. The rim 308 preferably includes at least one interruption 310. Referring to Figure 19, the illustrated interruption 310 has a larger opening 312 connected to a slot 314 that intersects with the rim 308. In the illustrated configuration, the rim 308 includes two interruptions 310. In the illustrated configuration, the interruptions 310 are positioned at the top and bottom of the opening 306. That is, when positioned within the user's nostril, the interruptions 310 are more likely to bend laterally in the configuration shown in Figure 19.

[0118] Depending on the configuration, the edge 308 defining the opening 306 is substantially elliptical, as shown in Figure 19, and includes a longer axis L1 and a shorter axis L2. In such configurations, the interruption 310 may intersect the longer axis L1. Depending on the configuration, one or more interruption 310 may be positioned along the portion of the edge 308 that is above the shorter axis L2. For example, a single interruption 310 may be positioned above the shorter axis L2. In some such configurations, a single interruption 310 may be positioned closer to the vertex of that portion of the elliptical opening 306. In some such configurations, a single interruption 310 may intersect the longer axis L1. In some such configurations, a single interruption 310 may be at the center of the longer axis L1.

[0119] Continuing to refer to Figure 19, the interruption 310 defines a recess in the nostril locator 302 that extends from the edge 308 into the material of the nostril locator 302. The interruption 310 can extend for any suitable distance along the length of the nostril locator 302. Preferably, the length is not so long as to create a leakage path, but long enough to allow some radial escape to the edge 308. As the length of the interruption 310 increases, the stiffness of the nostril locator 302 becomes softer.

[0120] Referring to Figures 20A to 20E, other configurations of the interruption 310 are shown. As illustrated, the interruption 310 can have many different shapes and can move away from the area of ​​the nasal locator 302 that contacts the septum. As illustrated, there can be just one or any number of interruptions 310 as desired. Depending on the configuration, the interruption 310 becomes the serrated end of the nasal locator 302. Other configurations are also possible.

[0121] Referring here to Figures 21 and 22, a sealing member 330 is shown. The sealing member 330 may have features, aspects and characteristics common to any other configuration described herein. In the illustrated configuration, the sealing member 330 comprises at least one flexible prong 332. Depending on the configuration, the sealing member 330 may comprise two flexible prongs 332. The flexible prong 332 has a distal end connected to a proximal surface 334. The flexible prong 332 may extend substantially proximal to the proximal surface 334. The flexible prong 332 may have one or more openings 336 located substantially proximal to the prong 332. In the illustrated configuration, the openings 336 may form a slit extending substantially vertically through the proximal outermost end.

[0122] The prong 332 preferably includes a stalk 340 extending substantially between the proximal surface 334 and the opening 336. The stalk 340 can be configured to rotate or flex easily. For example, the cross-sectional thickness of the material used to form the sealing member 330 and / or the flexible prong 332, which connects at least a portion of the prong 332 to the sealing member 330, can be reduced. Depending on the configuration, different materials or different grades of materials can be used to give the prong 332 high mobility.

[0123] In the illustrated configuration, as shown by comparing Figures 21 and 22, the prongs 332 can be configured to expand and contract in a nesting manner, or to extend / contract. By configuring the prongs 332 to extend, they can have high flexibility. As shown, the prongs 332 can be compressed along the axial direction. Compression can improve the comfort of the prongs 332 when sealing the user's nostrils.

[0124] Depending on the configuration, the prongs can be made in a bellows-type shape. The bellows shape can provide axial compressibility. The pleated appearance of the bellows shape can be formed along all or only a portion of the stalk 340. By providing the bellows shape, the stalk 340 also allows the proximal end of the prong 332 to swing around the distal end of the prong 332. That is, the proximal end of the prong 332 can bend in any direction without rotating the prong 332.

[0125] Referring here to Figures 23A to 23C, a portion of the sealing member 350 is shown. Depending on the configuration, the sealing member 350 includes a nasal locator 352 similar to that described above. At least the proximal portion of the nasal locator 352 can be partially or completely covered by an end member 354, as shown in Figures 23A to 23C, respectively. The end member 354 can be formed from a material that is as soft as or softer than the material of the nasal locator 352. Depending on the configuration, the end member 354 can be partially or completely formed from a softer silicone material. That is, by using the end member 354 and positioning it over the proximal end of the nasal locator 352, a high level of comfort can be provided.

[0126] The end member 354 can define an opening 356 through which airflow from the nasal locator 352 can pass. In the illustrated configuration, the end member 354 has a rounded appearance. The softer material and rounded shape allow the nasal locator 352 to rotate more easily around its axis. The nasal locator 352 below may be rigid enough to provide a structure, and the cap formed by the end member 354 can improve comfort. In some configurations, the proximal end of the nasal locator 352 can be surrounded by a perforated or laterally extending opening to allow air to flow out of the nasal locator, while the soft end member forms a seal with the user's nostrils. Furthermore, in some such configurations, the end member may have a larger outer diameter than the nasal locator 354 so that the end member 354 provides an effective sealing component and the nasal locator 352 can have improved flexibility.

[0127] Referring now to Figure 24, a further sealing member 360 is shown. The sealing member 360 includes a multi-wall nasal locator 362. In the illustrated configuration, the nasal locator 362 comprises a thin outer wall 364 and a thicker inner wall 366. Depending on the configuration, the outer wall 364 is spaced apart from the inner wall 366 so that the two walls can move relative to each other. Depending on the configuration, the inner wall 366 may terminate within the outer wall 364; that is, the outer wall 364 may extend further proximal to the inner wall 366.

[0128] The inner wall 366 may comprise, for example, a foamy or gel-like insert. The inner wall 366 lies beneath and supports the outer wall 364. Thus, the outer wall 364 can be formed from a very thin layer by the support of the separately formed inner wall 366. Depending on the configuration, the outer wall 364 may be a very thin silicone wall intermittently or substantially completely supported by the inner wall 366, which may be made of a much softer material than the outer wall 364.

[0129] Referring here to Figures 25A and 25B, a sealing member 380 is shown there. The sealing member 380 may include one or more nasal locators 382. Depending on the configuration, the sealing member 380 may be configured so that the nasal locators 382 direct the airflow in a more upward direction. Referring to Figure 25A, a nasal locator 382 directing the airflow more rearward is shown compared to the nasal locator 382 shown in Figure 25B. By raising the rearmost wall of the nasal locator (see 384), for example, the trajectory of the airflow can be changed to a more upwardly directed flow. Depending on the configuration, the nasal locator may be configured so that the resulting airflow is more upward and forward. By changing the direction of the airflow in this way, the airflow does not blow directly into the nose, thereby improving user comfort. Depending on the configuration, the nasal locator 382 may be positioned on, for example, but not limited to, a ball joint so that the user can adjust the airflow as needed.

[0130] Referring here to Figure 26, the illustrated sealing member 400 can be configured in any of the configurations described above. However, the illustrated configuration features a proximal surface 402 that omits one or both nostril locators. In the illustrated configuration, one or more of the nostril locators are replaced by openings 404 formed in the proximal surface 402. Thus, the user's nostrils can easily overextend the openings 404 formed in the proximal surface. The configuration in Figure 27 shows a single opening 404 that may be below one or both of the user's nostrils, and the configuration in Figure 28 also shows a single projection 406 that may help indicate to the user when the mask is properly positioned below the nose. Referring to Figure 28, depending on the configuration, the tip of the nose may be located at the intersection 408 of the two facet lines. To help the user confirm that the sealing member of the mask is positioned as desired relative to the nostrils, the projection 406 may be a short nostril locator, a full nostril locator, or any other suitable structure. Depending on the configuration, the nose may fit inside or around the opening, and the sealing member may expand around the user's nose. For example, to seal, the tip of the nose may enter the opening, or the opening may be located below the tip of the nose. In particular, if nothing extends into the user's nostrils, the expansion improves the sealing performance of the sealing member.

[0131] Referring here to Figures 29 to 42, further interface assemblies 420 arranged and configured according to specific features, embodiments, and advantages of the present invention are shown. The interface assembly 420 generally comprises a frame or body 422 and seals 424. The seals 424 can be removably fixed to the frame 422 for use. Depending on the configuration, multiple seals 424 may be provided for connection to the frame 422, which may differ in size, shape, flexibility, or any other desired properties. In the illustrated configuration, the frame 422 provides mounting points for headgear, etc. Other configurations are also possible.

[0132] The illustrated seal 424 incorporates a connecting or mounting assembly 426 that can be joined to a flexible sealing member 428. Referring to Figure 30, the sealing member 428 has a proximal surface 430 (i.e., the surface closest to the user's face during use) and a distal surface 432 (i.e., the surface further away from the user's face during use). In the illustrated configuration, the distal surface 432 defines an inlet opening 434. The opening 434 is configured to allow breathing gas to enter a chamber defined within the sealing member 428.

[0133] In the illustrated configuration, a rib or projection 436 circumscribes the opening 434. The rib or projection 436 is best shown in the cross-sectional view of Figure 34. As illustrated, a portion of the sealing member 428 connecting the rib or projection 436 to the distal surface 432 can extend substantially perpendicular or perpendicular to the axis of the inlet opening 434. Thus, the rib or projection 436 is offset inward by a portion of the distal surface 432. This radial offset allows the rib or projection to be captured by the mounting assembly 426. Other configurations are possible, taking into account the need to expose a more rigid mounting assembly 426 on the surface of the sealing member 428.

[0134] The mounting assembly 426 may be more rigid than the sealing member 428. Depending on the configuration, the mounting assembly 426 can be formed as a two-piece structure. For example, the mounting assembly 426 can capture the sealing member 428 with an inner member 438 and an outer member 440. The inner member 438 can be inserted through the inlet opening 434.

[0135] The inner member may have a sleeve 442 extending through the inlet opening 434. The sleeve 442 may be joined to a larger radius protrusion 444. The larger radius protrusion 444 may provide a position on which the rib or projection 436 of the sealing member 428 can lean. The sleeve 442 may be externally threaded or may include one or more external projections 444. The sleeve 442 may also include an internal coupler structure 446. The external threaded portion or projection 444 may be joined to a structure formed on the inner surface of the outer member 440. The outer member extends radially outward enough to capture the rib or projection 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 fixed to the sealing member 428.

[0136] As described above, the sleeve 442 of the inner member 438 includes an internal coupler structure 446. The internal coupler structure 446 mates with a corresponding structure on the frame 422 so that the seal 424 (i.e., the sealing member 428 and the mounting assembly 426) can be fixed to the frame 422 for use and removed for replacement. The frame 422 may have a flange or the like to which the mounting assembly 426 can be connected. In the illustrated configuration, the entrance portion of the frame 422 (i.e., the socket for connecting the ball and the socket) can incorporate a recess. On the other hand, the mounting assembly 426 can incorporate a protrusion, but other suitable structures can be used, taking into consideration that a sufficiently secure connection for use is desired, and a removable connection is desired for replacing the seal 424.

[0137] Depending on the configuration, the frame 422 and mounting assembly 426 may include orientation features. For example, in the illustrated configuration, the mounting assembly 426 may incorporate a knob, projection, or boss feature 448, and the frame 422 may incorporate a groove, recess, or relief feature 450. Aligning the knob 448 with the groove 450 allows for confirmation of the desired orientation between the seal 424 and the frame 422. Other suitable configurations may also be used, taking into account the need to obtain precise alignment and orientation confirmation of the seal 424 relative to the frame 422.

[0138] A preferred single-structure sealing member 428 will now be described in more detail with reference to Figures 35 to 42. As described above, the sealing member 428 may have regions of high flexibility and regions of high rigidity. These regions may be made of different materials, different grades of the same material, or different thicknesses. In the illustrated configuration, there are regions of different thicknesses. The thickest regions can be seen on the proximal surface 430 (shown in Figures 35 to 37) and the distal surface 432 (shown in Figures 38 to 40) in the ribs or projections 436 surrounding the inlet opening 434 and in the central portion of the wing 452. These regions are used for mounting and gripping, and therefore it is desirable that they be the thickest and hardest regions. Furthermore, as will be described in more detail below, at least in the wing region 452, the thickest region may support the thinner regions, providing some structure to the sealing member 428. Depending on the configuration, the thickness is 3.0 mm, and in some variations, it is possible to make it slightly larger or smaller, keeping in mind that you want this area to be rigid enough for mounting and gripping.

[0139] The next thickest region is the joining region 454, which joins the rib or projection 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 connection between the rib or projection 436 and the balance of the sealing member 428. Depending on the configuration, the thickness of the joining region 454 is approximately 1.0 mm, and in some variations, it can be slightly larger or smaller, taking into account the need to reduce or eliminate the possibility of tearing during normal use.

[0140] As described above, the nasal locator 456 can be positioned on the proximal surface 430. It is desirable that the nasal locator 456 be flexible enough to reduce or eliminate the possibility of causing irritation. It is also desirable that the nasal locator 456 be rigid enough to reduce the possibility of bulging or insufficient self-supporting and to indicate the correct position and orientation of the seal 424 to the face to the user. It is preferable that the nasal locator 456 be rigid enough to suppress or prevent significant collapse depending on the positioning of the locator 456 within the user's nostrils. Depending on the configuration, the thickness of the nasal locator 456 may be about 0.7 mm, and in some variations, it may be slightly larger or smaller, taking into consideration the need to reduce user discomfort while still being useful in positioning the mask.

[0141] As described above, some areas of the sealing member 428 can be configured to bulge, expand, etc. Having such an expandable surface allows the sealing member 428 to provide a more effective seal and to accommodate slight movements of the portion of the sealing member 428 against the user's face during use. In fact, the nostril locator 456 can be partially separated from the frame 422 through the most flexible area of ​​the sealing member 428, and this area surrounds the nostril locator 456 and separates it from the balance of the mask in the illustrated configuration. Thus, the peripheral region 458 can be defined to substantially surround the nostril locator 456. The peripheral region 458 can extend to the transition area between the proximal surface 430 and the distal surface 432. Depending on the configuration, the thickness of the peripheral region 458 is approximately 0.25 mm, and in some variations, it can be slightly larger or smaller, taking into account the need to allow some separation between the relatively rigid nostril locator 456 and the balance of the sealing member 428.

[0142] Apart from the specified area, the remaining portion of the illustrated sealing member 428 may be a transitional portion within the specified wall thickness. The illustrated sealing member 428 is merely one desired configuration, and specific variations are also possible.

[0143] As described above, and in particular as shown in Figure 41, the side portion or wing region 452 may have a reinforcing region in the form of a thickened region 470 that supports thinner areas of the body of the sealing member 428, such as the periphery region 458. The thickened region 470 may be a mirror image of each other, as the wing region 452 may be, so that the sealing member 428 is symmetrical with respect to its vertical central plane. The thickened region 470 may extend along a substantial portion of the length and / or height of the wing region 452 or the sealing member 428. In the illustrated configuration, the thickened region 470 may extend substantially along the entire length and substantially along the entire height of the wing region 452, and the wing region 452 may extend substantially along the entire height and substantially along the entire length of the sealing member 428. Thus, depending on the configuration, the thickened region 470 is essentially the same dimensions and shape as the distal surface 432 of the wing region 452.

[0144] The thickness of the walled region 470 can be substantially constant or of varying thickness. In the illustrated configuration, the peripheral or edge portion of the walled region 470 is thinner than the central portion of the walled region 470. In particular, the front edge portion of the walled region 470 is thinner than the adjacent and / or central portion, as well as the transition portion to the joint region 454 and the rib 436, in order to accommodate the mounting assembly 426. Preferably, the thickness of the front edge portion of the walled region 470 is greater than that of the joint region 454, at least up to the joint between the walled region 470 and the joint region 454. In the illustrated configuration, the thickness of the front edge portion of the walled region 470 gradually decreases towards the joint with the joint region 454.

[0145] Similarly, the posterior edge portion of the thickness region 470 is also thinner than the adjacent and / or central portion of the thickness region 470. This configuration maintains the flexibility of the posterior edge portion of the proximal surface 430 and suppresses or prevents significant bulging or expansion at the posterior edge portion of the distal surface 432. Advantageously, this configuration allows the sealing member 428 to provide sufficient sealing functionality to the outer portion of the user's nose and limits or avoids any significant bulging at the posterior edge portion of the distal surface 432, thereby providing the user with a sense of stability.

[0146] Referring to Figure 41, the rear edge of the sealing member 428, which can also be called the edge or edge face, may have a transitional portion 472 between the proximal surface 430 and the distal surface 432. In the illustrated configuration, the transitional portion 472 has a substantially rounded or curved wall portion. As will be described, depending on the configuration, the thickness of the walled region 470 begins to decrease gradually ahead of the transitional portion 472. However, in order to control bulging of the sealing member 428 and preferably limit or prevent any significant bulging of the distal surface 432, it is preferable that the thickness of a portion of the transitional portion 472 is greater than that of the flexible proximal surface 430 or surrounding region 458. In the illustrated configuration, the rear edge portion of the walled region 470 decreases in thickness relatively quickly toward the transitional portion 472, and then the thickness gradually decreases from the distal surface 432 toward the proximal surface 430. Depending on the configuration, the transition portion 472 may have a portion that defines a wall thickness approximately the same as the thickness of the flexible proximal surface 430, such as the surrounding region 458.

[0147] As shown in Figures 29-31, 35, 36, and 38-40, in particular, the lower rear corner of the wing region 452 is provided with an outward projection or outward projection corner 474. The outward projection corner 474 extends outward relative to the adjacent portion of the wing region 452 so as to be positioned laterally outward of the nose at a position substantially corresponding to the user's cheek or upper lip. Depending on the configuration, the outward projection corner 474 is positioned substantially above the portion of the upper lip that covers the user's canine teeth. The outward projection corner 474 can help to secure the sealing member 428 to the user's face. Depending on the configuration, this configuration can still provide the user with sufficient stability, while omitting further stability elements, so that the sealing member 428 is the only part of the mask that comes into contact with the user's face. Because the outward projection corner 474 is relatively rigid, it can at least partially convey a sense of stability to the user. Therefore, it is preferable that the thickened region 470 extends at least partially into the outer protruding corner 474, and, depending on the configuration, may extend at least substantially completely through the outer protruding corner 474. It is preferable that at least the rearmost and lowest portions of the distal surface 432 of the seal 424 include the thickened region 470. Within the outer protruding corner 474, the thickness of the thickened region 470 gradually decreases and can enter the transition portion 472 described above.

[0148] As described above, the wing region 452 can be used, in particular, as a gripping portion of the seal 424 for initially positioning the mask on the face, repositioning the mask on the face, removing the seal 424 from the frame or body 422, or connecting the seal 424 to the frame or body 422. As described, the thickened region 470 can make the seal 424 on the distal surface within the wing region 452 easier to grip by limiting the collapse of the seal 424 in response to the strong grip of the wing region 452. Depending on the configuration, the distal surface 432 of the seal 424 may include surface features (e.g., one or more recesses or protrusions) configured to facilitate gripping. Such features may be called grip surfaces or grips.

[0149] Each illustrated wing region 452 includes a grip surface 480 formed by a projection 482. The projection 482 extends outward from the adjacent surface to a degree sufficient to provide some resistance to the user's finger sliding along the surface of the seal 424. The illustrated projection 482 is roughly crescent-shaped, which defines a roughly scallop-shaped grip surface 480. The end of the projection 482 is positioned behind the central curved portion of the projection 482. The user's finger or thumb can be positioned within the grip surface 480, and the user can press the projection 482 when attaching the seal 424 to the frame or body 422. Thus, the projection 482 compensates for the inwardly tapering or curved shape of the seal 424, otherwise the seal 424 may be slidable along the distal surface 432 of the seal 424 by the user's finger or thumb. The grip surface 480 and / or protrusions 482 may also assist the user in removing the seal 424 from the frame or body 422, or in positioning or repositioning the mask. Other suitable grip configurations may also be provided, such as multiple protrusions, recesses, or other surface features that enhance grip on smooth surfaces. Materials or material treatments that improve grip may also be used.

[0150] The seal 424 may optionally or additionally include a grip surface or other feature defining a grip. For example, referring to Figures 29, 30, and 32, the seal 424 may include a relatively rigid grip 484. In the illustrated configuration, 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 rearward projection or tab of the outer member 440, and the grip 484 may extend rearward from the annular portion of the outer member 440 on the distal surface 432 of the seal 424. The seal 424 may define a recess to receive the grip 484, and the outer surface of the grip 484 may be aligned with an adjacent outer surface of the seal 424. The inner member 438 is substantially in line with the grip 484 but includes a portion 486 that extends rearward within the internal space of the seal 424, and the seal can be captured between the grip 484 and the rearward-extending portion 486 of the inner member 438. The grip 484 may define one or more surface features 488, such as one or more protrusions or recesses, that enhance the gripping force.

[0151] 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 both sides of the seal 424. For example, a pair of opposing grips 484 can be provided on the top and bottom of the seal 424 and / or on both sides. Depending on the configuration, the grip surface 480 and / or projection 482 can be defined by a rigid structure, such as part of the mounting assembly 426 (e.g., outer member 440). Depending on the configuration, the mounting assembly 426 may include the projection or provide other rigid portions that extend for a considerable length and / or height of the wing region 452 of the seal 424.

[0152] As described above, the nasal locator 456 can be separated at least somewhat from the balance of the sealing member 428. Depending on the configuration, the sealing member 428 can be configured to allow the nasal locator 456 to move preferentially or to move preferentially. In some such configurations, the sealing member 428 can be configured to have less resistance to tilting movement in at least one direction relative to at least one direction. Preferably, the sealing member 428 includes one or more features that cause the nasal locators 456 to tilt outward or to be easily tilted so that they move away from each other. That is, it is preferable that the outward tilt of the nasal locator 456 has less resistance than tilting in one or more other directions (e.g., inward, upward, or downward). Such a configuration can reduce the discomfort that may otherwise occur when the nasal locator 456 pinches the nasal septum of the user. The configurations disclosed herein can be applied to other types of seals or patient interfaces, such as nasal pillows or any configurations incorporating other sealing or unsealing prong-shaped nasal elements.

[0153] Any suitable configuration or structure can be used to allow the nostril locator 456 to move preferentially or to facilitate preferential movement. In the illustrated configuration, the sealing member 428 includes a thin-walled region extending around at least a portion of the nostril locator 456, the thin-walled region facilitating the inclination or flexion of the nostril locator 456, and is referred to herein as the flex region 490. Depending on the configuration, the flex region 490 is located within an annular transition portion surrounding the nostril locator 456 between the nostril locator 456 and the surrounding region 458. The transition portion can be formed partially or completely by the base portion of the nostril locator 456, partially or completely by the portion of the surrounding region 458 adjacent to the base portion of the nostril locator 456, or a combination of the two. In other configurations, the flex region 490 may be located in another suitable position to allow the nostril locator 456 to flex preferentially.

[0154] Depending on the configuration, the flexure region 490 is located on the base of the nasal locator 456, and in the illustrated configuration, it is substantially entirely located on the base of the nasal locator 456. The flexure region 490 may comprise a thin-walled section at the base of the nasal locator 456. The thin-walled section is less thick than the rest of the nasal locator 456. Depending on the configuration, the thin-walled section defining the flexure region 490 may be the thinnest part of the nasal locator 456. Depending on the configuration, the wall thickness of the thin-walled section is about half or less of the wall thickness of a significant portion or the rest of the nasal locator 456. For example, depending on the configuration, the thickness of the thin-walled section of the flexure region is about 0.35 mm, and the thickness of at least the main portion of the nasal locator 456 is about 0.8 mm. Depending on the configuration, the tip of the nasal locator 456 is thinned for comfort. However, if a flexure region 490 is provided, the tip may have the same or substantially the same wall thickness as the rest of the nasal locator 456, in order to improve user feedback, suppress collapse when inserted into the nostril, and ensure comfort during use. The thin-walled section defining the flexure region 490 may have a greater thickness than the surrounding region 458.

[0155] The flex region 490 preferably extends around only a portion of the periphery of each nostril locator 456. Depending on the configuration, the flex region 490 may be limited to less than half of the periphery of the nostril locator 456. Depending on the configuration, the flex region 490 may be limited to the outside of the periphery of the nostril locator 456. In the illustrated configuration, the flex region 490 extends around more than one-third but less than or equal to half of the periphery of each nostril locator 456.

[0156] Referring particularly to Figure 42, the exit aperture 492 defined by the nostril locator 456 is substantially elliptical, each defining a principal axis 494 along the maximum width of the exit aperture 492, and a minor axis 496 perpendicular to the principal axis 494. Depending on the configuration, the deflection region 490 is substantially or completely confined to one side (e.g., the outside) of the principal axis 494. The lower end of the deflection region 490 may be on or near the principal axis 494, and the upper end of the deflection region 490 may be spaced away from the principal axis 494. Such a configuration allows for inclination outward and slightly downward relative to the principal axis 494. The length and / or position of the deflection region 490 can be modified to give the inclination or deflection in the desired direction. Depending on the configuration, assuming the lower end of the principal axis 494 is 0 degrees, the deflection region 490 can extend from about 5 degrees to about 150 degrees.

[0157] For at least one reason, the shape of the sealing member 428 in Figures 29 to 42 is a modification of the shape of the nose seal currently commercialized by the applicant, Fisher & Paykel Healthcare Limited, in the Pilairo® nasal mask, in order to provide the flexure region 490 and other features described herein. For example, the main shaft 494 is rotated perpendicularly by about 10 degrees relative to the orientation of the current Pilairo® nasal mask. The main shaft 494 is oriented at an angle of about 20 to 25 degrees with respect to the vertical central plane through which the sealing member 428 passes, and the lower end of the main shaft 494 is farther outward (further from the central plane) than the upper end of the main shaft 494. The surface defining the tip of the nostril locator 456 is rotated outward by approximately 4 degrees compared to the current Pilairo® nasal mask, resulting in the surface defining an angle of approximately 20 to 25 degrees in the central plane, with the outer portion of the tip of the nostril locator 456 being considerably further back than the inner portion. The length of the nostril locator 456 is shortened by approximately 1 mm to 11 mm. The exit aperture 492 defines a more rounded shape. For example, the dimension along the main axis 494 may be approximately 10 mm, and the dimension along the minor axis may be approximately 5.5 mm. The nostril locators 456 are also slightly wider apart. For example, the distance between the main axes 494 at the base and tip of the nostril locator 456 may be approximately 18.5 mm and 11 mm, respectively.

[0158] Referring to Figure 43, a further interface assembly 500 is shown, arranged and configured according to specific features, aspects, and advantages of the present invention. The interface assembly 500 generally comprises a frame or body 502 and a seal 504. The seal 504 can be removably fixed to the frame 502 for use. In the illustrated configuration, the frame 502 provides mounting points for headgear, etc. The illustrated seal 504 incorporates a coupling or mounting assembly 506 that can be joined to a flexible sealing member 508. The sealing member 508 comprises a proximal surface 530 (i.e., the surface closest to the user's face during use) and a distal surface 532 (i.e., the surface further away from the user's face during use). The interface assembly 500 is described in terms of its differences from other interface assemblies described herein. Thus, features not described can be assumed to be the same as or similar to the corresponding features of other interface assemblies disclosed herein, or may be another suitable configuration.

[0159] The sealing member 508 in Figure 43 preferably includes features that facilitate or promote the flexing of the upper central portion of the sealing member 508, which is aligned with the user's nose, in order to suppress or prevent excessive pressure from being applied to the nose. Depending on the configuration, the portion of the sealing member 508 defining both the proximal surface 530 and the distal surface 532 of the central portion flexes forward to accommodate the user's nose. That is, depending on the configuration, the entire upper central portion of the sealing member 508 may flex forward, rather than the proximal surface 530 simply approaching the distal surface 532, which is often substantially stationary, thereby stretching the proximal surface 530 and potentially causing discomfort. The flexing of the sealing member 508 may not occur in all situations. For example, with certain face shapes, little or no flexing may occur, while with other face shapes, significant flexing may occur.

[0160] The illustrated sealing member 508 includes a rib or projection 536 that connects to the connecting or mounting assembly 506. The joining region 554 can connect the rib or projection 536 to the balance of the sealing member 508. Depending on the configuration, the thickness of the joining region 554 may be approximately 1.0 mm, and in some variations, it may be slightly larger or smaller, taking into consideration the need to reduce or eliminate the possibility of tearing during normal use. However, the upper central portion 560 of the sealing member 508 may include the portion of the joining region 554, but it is preferable to have a thinner wall thickness to facilitate or promote flexing (illustrated by dashed lines). The wall thickness of the upper central portion 560 may be the same as or similar to the surrounding region 458 of the sealing member 428 in Figures 29 to 42, for example, approximately 0.25 mm. Depending on the configuration, the upper central portion 560 may be connected to or integrated with the surrounding region 558 surrounding the nostril locator 556 of the sealing member 508. In the illustrated configuration, the thin wall thickness of the upper central portion 560 begins substantially immediately outside the connecting or mounting assembly 536. Other suitable configurations can also be used that allow the upper central portion 560 of the sealing member 508 to flex and / or rotate, such as the concepts and configurations disclosed in International Publication No. 2014 / 062070, which is incorporated herein by reference in its entirety.

[0161] Unless the context clearly indicates otherwise, terms such as “equipped with” and “possessing” throughout the description and claims should be interpreted in a comprehensive sense, as opposed to an exclusive or exhaustive sense; that is, “includes but not limited to.”

[0162] No prior art reference in this specification should be interpreted as an acknowledgment or suggestion in any form that the prior art forms part of the general knowledge common in any country's area of ​​focus.

[0163] The present invention may also be said to be, in general terms, in the parts, elements and features referenced or shown in the specification of this application, individually or collectively, in any combination of two or more of said parts, elements or features.

[0164] Where integers, or their equivalents, refer to known components as described above, those integers are incorporated herein as they are individually.

[0165] It should be noted that various modifications and alterations of the current preferred embodiments described herein will be obvious to those skilled in the art. Such modifications and alterations may be made without departing from the spirit and scope of the invention and without impairing its associated advantages. For example, various components may be repositioned as needed. Thus, such modifications and alterations are included within the scope of the invention. Furthermore, not all of the features, embodiments and advantages are necessarily required to carry out the invention. Accordingly, the scope of the invention is defined solely by the following claims.

Claims

1. A nasal seal configured to be detachably connected to the frame of a patient interface, It is formed from a soft, flexible material and comprises a seal body defining an internal cavity and one or more outlets for supplying respiratory gas from the internal cavity to the patient, The seal body comprises a central portion and lateral portions extending from each end of the central portion, the seal body further comprising an internal side and an external side, the internal side of the central portion configured to extend over the base of the user's nose, and the internal side of each lateral portion configured to extend over the side of the nose, the internal side of the seal being flexible and configured to conform to the surface of the user's nose, including the outer surface of the side of the nose, under internal pressure, each lateral portion defining a transition between the external side and the internal side, the external side of each lateral portion having a reinforcing region that is harder or much harder than the flexible internal side, the reinforcing region extending to or substantially to the transition. Nose stickers.

2. The nose seal according to claim 1, wherein the reinforcing region is formed by a relatively thick portion of the seal body.

3. The nose seal according to claim 2, wherein the thickness of the thick portion gradually decreases in front of the transition portion.

4. The nose seal according to claim 3, wherein the transition portion includes a portion that is thicker than the flexible inner surface.

5. The nose seal according to any one of claims 1 to 4, wherein the reinforcing region extends substantially along the entire length of the outer surface of the seal body.

6. The nose seal according to any one of claims 1 to 5, wherein the transition portion comprises a rounded wall section.

7. A nose seal according to any one of claims 1 to 6, further comprising a support made of a relatively rigid material and supporting a portion of the seal body.

8. The nose seal according to claim 7, wherein the support defines at least one grip surface portion extending along the outer side surface of the seal body.

9. The nose seal according to claim 8, wherein the at least one grip surface portion comprises at least one pair of grip surface portions substantially facing each other.

10. The nose seal according to any one of claims 7 to 10, wherein the support defines a mounting device for attaching the nose seal to the frame.

11. The nose seal according to claim 10, wherein the mounting fixture comprises a first member connectable to a second member, and the first member and the second member capture a portion of the seal body between them.

12. The nose seal according to claim 11, wherein the first member is positioned within the cavity of the seal body and comprises a sleeve portion extending outward from the cavity.

13. The nose seal according to claim 12, wherein the second member surrounds the sleeve portion of the first member.

14. The nose seal according to any one of claims 1 to 13, wherein the reinforcing region is located within the rearmost and lowest sections of the side portion.

15. The nose seal according to claim 14, wherein the rearmost and lowest sections of the side portion extend outward relative to the adjacent portion of the seal body.

16. The nose seal according to any one of claims 1 to 15, wherein the one or more outlets further comprises a nostril locator associated with and forming a portion of each outlet, and a flexible region is defined within an annular transition portion between each nostril locator and the surrounding portion of the inner side surface, and the flexible region has a lower stiffness than another region of the annular transition portion that is not within the flexible region.

17. The nose seal according to claim 16, wherein a lower hardness is achieved by the flexible region having less thickness than the other regions of the annular transition portion.

18. The nasal seal according to claim 16 or 17, wherein the bending region is located on the outer side surface of the nostril locator.

19. The nose seal according to any one of claims 16 to 18, wherein the bending region is limited to half or less of the annular transition portion.

20. The nose seal according to any one of claims 1 to 19, wherein the central portion of the seal body defines a thin-walled region that allows the upper part of the inner side surface of the central portion to move forward as a result of the rotational movement of the seal body.

Images