Patient interface and aspects thereof

Abstract

To provide an improved sealing member for use in a mask assembly that overcomes shortcomings of conventional sealing members.SOLUTION: A ballooning patient interface has a frame that supports a sealing member. The frame and / or the sealing member is secured to the head of a user with a headgear, such as a strap. Various features of the sealing member improve comfort of the user in the nares of the user as well as on facial surfaces in contact with the sealing member.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] INCORPORATION BY REFERENCE OF ANY PRIOR APPLICATION All applications for which a foreign or domestic priority claim is identified in the Application Data Sheet filed with this application are hereby incorporated by reference in their entirety and made a part of this disclosure.

[0002] FIELD OF THEINVENTION The present invention relates generally to an interface for providing a supply of pressurized gas to a receiver. [Background technology]

[0003] Respiratory gas can be delivered to a user through a variety of different mask styles and for a variety of different purposes. For example, non-invasive ventilation (NIV) can be used to provide pulmonary ventilation to a user. Additionally, masks 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 the placement of a user interface device, typically a nasal or nose / mouth mask, on the user's face through which a flow of breathing gas can be delivered from a pressure / flow generating device to the user's airways.

[0005] Typically, the patient interface device includes a mask frame that supports a sealing member. The sealing member contacts the user's face, including the nose and the area surrounding the nose, including the nostrils. Such masks are typically worn for extended periods of time, and various concerns must be taken into consideration. For example, when performing CPAP to treat OSA, the user typically wears the mask all night while sleeping. One concern in such situations is that the mask should be as comfortable as possible. It is also important that the mask provides an adequate seal against the user's face without significant discomfort. Summary of the Invention [Problem to be solved by the invention]

[0006] It is therefore an object of certain embodiments of the present invention to provide an improved sealing member for use in a mask assembly that overcomes the shortcomings of conventional sealing members. [Means for solving the problem]

[0007] In some configurations, a nasal seal configured to removably couple to a patient interface or a frame of a patient interface incorporating the seal includes a seal body formed from a soft, flexible material and defining an interior cavity and one or more outlets for delivering respiratory gas from the interior cavity to a 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 interior side and an exterior side, the interior side of the central portion configured to extend across the base of a user's nose and the interior side of each side portion configured to extend across the side of the nose. The interior side of the seal is flexible and configured to conform under internal pressure to a surface of the user's nose, including the exterior surface of the side of the nose at the side portions of the seal. Each side portion defines a transition portion between the exterior side and the interior side, the exterior side of each side portion including a reinforced region that is stiffer or much stiffer than the flexible interior side, the reinforced region extending to or substantially to the transition portion.

[0008] In some such configurations, the reinforced region is formed by a relatively thickened portion of the seal body, which may taper in thickness before a transition portion, which may include a portion that is thicker than the flexible interior side.

[0009] In some such configurations, the reinforced region extends along substantially the entire length of the exterior side of the seal body.

[0010] In some such configurations, the transition portion comprises 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 can define at least one grip surface portion extending along an exterior side of the seal body. The at least one grip surface portion can include at least one pair of grip surface portions substantially opposed to one another.

[0012] In some such configurations, the support defines a fitting for attaching the nose seal to the frame. The fitting can include a first member connectable to a second member, the first member and the second member capturing a portion of the seal body therebetween. The first member can be positioned within a cavity of the seal body and can include a sleeve portion extending outwardly from the cavity. The second member can surround the sleeve portion of the first member.

[0013] In some such configurations, the reinforced regions are disposed within the aft and lowest sections of the side portions, which can extend outwardly relative to adjacent portions of the seal body.

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

[0015] In some such configurations, the lower stiffness is achieved by a flexure region that is less thick than other regions of the annular transition portion. The flexure region may be located on an outer side of the nostril locator. The flexure region may be limited to no more than one-half of the annular transition portion.

[0016] In some such configurations, the central portion of the seal body defines a reduced thickness region that allows an upper portion of the inner side of the central portion to move forward as a result of rotational movement of the seal body.

[0017] In some configurations, a nasal seal configured to removably couple to a patient interface or a frame of a patient interface incorporating the seal includes a seal body formed from a soft, flexible material and defining an interior cavity and one or more outlets for delivering respiratory gas from the interior cavity to a 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 interior side and an exterior side, the interior side of the central portion configured to extend across the base of a user's nose and the interior side of each side portion configured to extend across the side of the nose. The interior side of the seal is flexible and configured to conform under internal pressure to a surface of the user's nose, including the exterior surface of the side of the nose at the side portion of the seal. The exterior side of each side portion includes a reinforced region that is stiffer or much stiffer than the flexible interior side, the reinforced region being located within the rearmost and lowest sections of the side portion.

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

[0019] In some such configurations, the flared side portions are generally aligned with the surface of the user's cheek or upper lip and laterally outwardly of the nose.

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

[0021] In some such configurations, the thickened portion tapers in thickness before the transition between the inner and outer sides.

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

[0023] In some configurations, a nasal seal configured to removably couple to a patient interface or a frame of a patient interface incorporating the seal includes a seal body formed from a soft, flexible material and defining an interior cavity and one or more outlets for delivering respiratory gas from the interior cavity to a 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 interior side and an exterior side. The interior side of the central portion is configured to extend across the base of a user's nose, and the interior side of each side portion is configured to extend across a side of the nose. The interior side of the seal is flexible and configured to conform under internal pressure to a surface of the user's nose, including the outer surface of the side of the nose at the side portion of the seal. The exterior side of each side portion includes a reinforced region that is stiffer, or much stiffer, than the flexible interior side. The exterior side of the seal body further defines a grip surface on each side portion, the grip surface being located on the reinforced region.

[0024] In some such configurations, the gripping surface is formed by a protrusion.

[0025] In some such configurations, the projection is generally crescent shaped, thereby defining a generally scallop shaped gripping surface.

[0026] In some such configurations, the end of the protrusion is positioned rearward of a central curved portion of the protrusion.

[0027] In some configurations, a nasal seal configured to removably couple to a patient interface or a frame of a patient interface incorporating the seal includes a seal body formed from a soft, flexible material and defining an interior cavity and one or more outlets for delivering respiratory gas from the interior cavity to a 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 interior side and an exterior side. The interior side of the central portion is configured to extend across the base of a user's nose, and the interior side of each side portion is configured to extend across a side of the nose. The interior side of the seal is flexible and configured to conform under internal pressure to a surface of the user's nose, including an exterior surface of the side of the nose at the side portions of the seal. 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 an exterior side of the seal body.

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

[0029] In some such configurations, the at least one grip surface portion comprises at least a pair of grip surface portions substantially opposed to one another.

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

[0031] In some such configurations, the fitting includes a first member connectable to a second member, the first member and the second member capturing a portion of the seal body therebetween.

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

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

[0034] In some configurations, a nasal seal configured for removably coupling to a patient interface or a frame of a patient interface incorporating the seal includes a seal body formed from a soft, flexible material and defining an interior cavity. The seal body includes a central portion and side portions extending from each end of the central portion. The seal body further includes an interior side and an exterior side. The interior side of the central portion is configured to extend across the base of a user's nose and the interior side of each side portion is configured to extend across a side of the nose. The interior side of the seal is flexible and configured to conform under internal pressure to a surface of the user's nose, including the exterior surface of the side of the nose at the side portions of the seal. The seal body includes a first outlet and a second outlet for delivering breathing gas from the interior cavity to the user's nares. A nostril locator is associated with and forms a portion of each outlet. A flexure area is defined within a transition between each nostril locator and a peripheral portion of the interior side. The flexure region has a lower stiffness than other regions of the transition portion that are not within the flexure region.

[0035] In some configurations, the flexure area has a smaller thickness than other areas of the transition portion.

[0036] In some configurations, the deflection areas are located on the outside of the nostril locators so that the nostril locators tend to move outwardly, away from each other.

[0037] In some configurations, the flexure area is limited to no more than one-half of the transition portion, which may be generally annular.

[0038] In some configurations, the patient interface, or the seal arrangement of the patient interface, includes a first outlet and a second outlet for delivering respiratory gas from the internal cavity to the user's nares. A nostril locator or seal 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 between each nostril locator or seal member and a peripheral portion of the seal arrangement. The flexure region has a lower stiffness than other regions of the transition that are not within the flexure region. The lower stiffness may be achieved by reducing a wall thickness within the flexure region as compared to other regions. The flexure region may be located on the exterior of the nostril locator or seal member to facilitate outward tilt. The flexure region may be limited to about one-half or less of the annular transition, which may be generally annular.

[0039] In some configurations, a sealing member is provided on the mask having any set or subset of the features described herein, or any combination of sets or subsets of features. In some such configurations, the mask may have such a sealing member.

[0040] In some configurations, the seal member includes a proximal surface and a distal surface. The proximal surface has one or more outlet ports for supplying breathing gas to a patient. The proximal surface and the distal surface define an internal cavity within the seal member. At least one integral support structure underlies at least a portion of the internal cavity.

[0041] In some such configurations, the at least one integral support structure comprises a crescent shaped member that is structurally integral to the seal member.

[0042] In some such configurations, the at least one integral support structure extends at least partially upwardly along at least a portion of the distal surface. In some such configurations, the at least one integral support structure extends upwardly along the distal surface. In some such configurations, a portion of the at least one integral support structure that extends upwardly along the distal surface extends proximally and is configured to support an area of ​​the user along the cheek region.

[0043] In some such configurations, a portion of the integral support structure underlying the interior cavity extends proximally and is configured to support an area of ​​the user directly above the lips.

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

[0045] In some such configurations, the at least one integral support structure is positioned in 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 seal member has thicker walls in an area including the bottom of the edge surface compared to an area generally surrounding the one or more outlets. In some such configurations, the thicker walled area extends upward from the bottom of the edge surface.

[0046] In some such configurations, the at least one integral support structure is positioned so as to be within the widest lateral region of the seal member.

[0047] In some such configurations, at least one integral support structure extends most proximally of any other portion of the seal member.

[0048] In some such configurations, at least one integral support structure is positioned so that it is within the widest lateral region of the seal member and extends most proximally of any other portion of the seal member.

[0049] The various features, aspects, and advantages of the present invention can be implemented in any of a variety of ways. For example, several embodiments are described herein, but any set or subset of the features of the embodiments can be used with any set or subset of the features of the other embodiments.

[0050] The term "comprising" is used in the present specification and claims to mean "consisting at least in part of." In interpreting a statement in the present specification and claims that includes "comprising," other features or features beginning with this term may also be present. Related words such as "comprise" and "comprises" should be interpreted in the same manner.

[0051] Where this specification refers to patents, other external documents or other sources, the references are generally for the purpose of providing a context for describing features of the present invention. Unless specifically stated otherwise, the reference to such external documents should not be construed as an admission in any capacity that such documents or such sources are prior art or form part of the common general knowledge in the art.

[0052] These and other features, aspects and advantages of the present invention are described with reference to the following drawings. [Brief description of the drawings]

[0053] [Figure 1] FIG. 1 is a front view of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Diagram 2] FIG. 2 is a side view of the interface assembly of FIG. 1. [Diagram 3] FIG. 2 is a rear view of the interface assembly of FIG. 1. [Figure 4] FIG. 2 illustrates an interface assembly having certain characteristics in common with the interface assembly of FIG. 1 worn by a user. [Diagram 5] 1 is a partially exploded view of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 6] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 7] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 8] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 9A] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 9B] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 9C] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 9D] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 9E] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 9F] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 10] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 11] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 12] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 13] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 14A] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 14B] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 14C] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 14D] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 15A] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 15B] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 15C] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 15D] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 16] 1 is a rear view of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 17] FIG. 17 is a bottom view of a portion of the interface assembly of FIG. 16. [Figure 18]FIG. 17 is a perspective view of a portion of the interface assembly of FIG. 16. [Figure 19] FIG. 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention; [Figure 20A] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 20B] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 20C] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 20D] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 20E] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 21] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 22] 1 is a diagram of a portion of a nasal cavity and a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 23A] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 23B] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 23C] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 24] 1 is a diagram of a portion of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 25A]1A-1C are diagrams of a prior art interface assembly and an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 25B] 1A-1C are diagrams of a prior art interface assembly and an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 26] 1 is a diagram of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention; [Figure 27] FIG. 13 is a diagram of another interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 28] FIG. 13 is a diagram of another interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Figure 29] FIG. 1 is a partially exploded perspective view of an interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. [Diagram 30] FIG. 30 is a more fully exploded perspective view of the interface assembly of FIG. 29. [Diagram 31] FIG. 30 is a perspective view of the interface assembly of FIG. 29. [Diagram 32] 32 is a cross-sectional view taken along line AA in FIG. 31. [Diagram 33] 33 is a cross-sectional view taken along line BB in FIG. 32. [Diagram 34] FIG. 34 is an enlarged view of a portion of FIG. 33. [Diagram 35] 30 is a diagram of the seal member in the interface assembly of FIG. 29 showing the material thickness of the proximal wall. [Diagram 36] 30 is a diagram of the seal member in the interface assembly of FIG. 29 showing the material thickness of the proximal wall. [Figure 37] 30 is a diagram of the seal member in the interface assembly of FIG. 29 showing the material thickness of the proximal wall. [Figure 38] FIG. 13 is a diagram of a seal member showing the material thickness of the distal wall. [Figure 39]FIG. 13 is a diagram of a seal member showing the material thickness of the distal wall. [Diagram 40] FIG. 13 is a diagram of a seal member showing the material thickness of the distal wall. [Diagram 41] 34 is an enlarged view of a portion of the cross section of the seal member shown in FIG. 33. [Diagram 42] 30 is a rear view of the seal member in the interface assembly of FIG. 29. [Diagram 43] 1 is a cross-sectional view of another interface assembly arranged and configured in accordance with certain features, aspects and advantages of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0054] 1 illustrates a patient interface 100 arranged and configured in accordance with certain features, aspects and advantages of the present invention. The interface 100 may be used to deliver pressurized breathing gas to a recipient. The interface 100 is well suited for providing breathing gas to a recipient in situations where significant pressure changes may occur. For example, but not by way of limitation, the interface 100 may be used to deliver continuous positive airway pressure (CPAP).

[0055] With continued reference to FIG. 1 , the interface 100 is shown separated from a patient who will be wearing the interface 100. Several aspects of the patient interface 100 and variations of each aspect are described in U.S. Patent Application Serial 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. In some configurations, a strap 104 may be attached to the mask 102 and may be used to secure the mask 102 to the patient. In some configurations, the interface 100 also comprises a flexible supply conduit 106 that may be coupled to the mask 102.

[0056] With continued reference to Figure 1 and further reference to Figure 2, the mask 102 is configured to fit or cover both nostrils of the patient. In some configurations, the mask 102 can 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 with the outwardly facing surfaces of the flanks of the nose. The straps 104 can wrap around the user's head in simple loops above the user's ears.

[0057] The flexible conduits 106 may depend from a central connection 112. In some configurations, the central connection 112 may be positioned at a front portion of the mask 102. The central connection 112 preferably comprises a swivel elbow. The elbow allows the flexible conduits 106 to pivot relative to the mask 102. By allowing pivoting, the elbow may help the interface 100 to better accommodate the patient's sleep position. In some configurations, the central connection 112 may comprise a ball joint to allow the elbow to pivot about 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 the frame 116 may be connected in any suitable manner.

[0059] The seal 114 preferably defines a flexible pocket or covering that may include recessed areas. In some configurations, the seal 114 may have a thin wall thickness and may be formed from any suitable material. For example, but not limited to, the seal 114 may be formed from latex, vinyl, silicone, or polyurethane. In some configurations, the wall thickness may be less than about 0.5 mm, and in some areas and configurations, may be less than about 0.2 mm. In some configurations, the seal 114 may be formed from a material that has sufficient elasticity and yield strength such that the combination of elasticity and yield strength makes the seal 114 flexible. The seal 114 is preferably capable of withstanding repeated significant deformation without breaking.

[0060] 3, the seal 114 preferably includes one or two nostril locators 120. The nostril locators 120 may protrude from the seal 114. In some configurations, the nostril locators extend generally superiorly and posteriorly from a proximal wall 124 of the seal 114. In some configurations, the nostril locators 120 extend generally posteriorly from the proximal wall 124 of the seal 114.

[0061] 1-3, nostril locators 120 are integrally (i.e., one unitary piece) formed with seal 114. Each nostril locator 120 may include an exit aperture 118 through which gas may be supplied from flexible conduit 106. In some configurations, gas may be supplied from within a pocket or enclosure defined by seal 114. In other configurations, the supplied gas may be separate from the gas supplied to the pocket or enclosure defined by 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. An edge 126 (see FIGS. 1 and 2 ) may connect the periphery of the distal wall 122 and the periphery of the proximal wall 124. The above-described cover or pocket may be defined in at least the distal wall 122 and the proximal wall 124.

[0063] The seal 114 is preferably designed to wrap around the tip or bottom of the user's nose (e.g., at a location below the bridge of the nose). As such, the illustrated seal 114 includes a central portion 128 (see FIG. 1) positioned between side portions or wings 130. The central portion 128 may be below the user's nose and preferably incorporates a nostril locator 120. In some configurations, 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 may 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 noted above, at least a substantial portion of the seal 114 may be flexible. For example, the area surrounding the nostril locators 120 may be more flexible than at least a portion of the wings 130. At least the proximal wall 124 and the edges 126 of each side portion may be highly flexible so as to be able to expand to conform to the contours of the user's face, particularly the contours of the outer flanks of the user's nose. The flexible portions of the seal 114 are preferably of sufficient size and shape to allow the seal 114 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 inflated seal is pressed against the user's face with the nostril locators 120 engaged within the user's nares.

[0065] However, to improve the shape, fit and function of the mask 102, select portions of the seal 114 can have a high stiffness. For example, at least a portion of the edge 126 can be made significantly stiffer to control bulging of other areas of the seal 114. Additionally, the area adjacent to and including the inlet opening of the seal 114 (e.g., the portion that receives gas flow from the conduit 106) can be made less flexible. Thus, the distal wall 122 can have a low flexibility from the wings 130 to the central portion that includes the inlet opening. The less flexible areas can be formed from different materials or can be formed from the same material but with a greater thickness.

[0066] As described above, the frame 116 supports the seal 114. In some configurations, 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, such that gas can be supplied to the seal 114 through the frame 116. In other configurations, the seal 114 couples directly to the flexible conduit 106. In some configurations, the seal 114 can couple to the conduit 106 at a central connection 112.

[0067] The frame 116 may have any suitable configuration for securing the seal 114. In some configurations, an annular wall may extend around an opening that extends from the proximal side of the frame 116 to the connector 112. The annular wall may include an outwardly extending lip. The inlet opening of the seal 114 may over-engage the outwardly extending lip of the annular wall. In some configurations, the inlet opening of the seal 114 may be stretched to fit into the annular wall. The inlet opening of the seal 114 may include, for example, but not limited to, a thickened or reinforced wall section. In some configurations, the extension of the seal 114 may be rolled up onto the annular wall of the frame 116. In another configuration, the seal 114 may include a portion 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, the reduced dimensions of the frame 116 provide a clearer view for the user and allow the user to wear eyeglasses while wearing the interface 100. The frame 116 is preferably formed from an elastomeric material, which allows the frame 116 to flex slightly to conform to the user's face. However, the frame 116 supports the seal 114. By supporting the seal 114, the seal can be more effectively pressed into contact with the user's face and around the nose. The frame 116 can be formed by injection molding, preferably from an elastomeric material, such as, but not limited to, silicone or polyurethane. In some configurations, the frame 116 can be formed from a more rigid material, such as, but not limited to, polycarbonate, polyester polystyrene, or nylon.

[0069] In use, the flexible portions of the proximal wall 124 above, below and on either side of the nostril locator 124 can be inflated by pressure within the seal 114 (e.g., from the flow of gas provided to the patient interface 100) and pressed against the user's skin to conform to the contours 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 just below the nose. The flexibility around or periphery of the seal 114 allows the mask 102 to move in all directions (other than directly away from the face) at least to a small extent, so that movement of the mask 102 does not significantly disrupt this seal with the face. The flexible portions of the seal 114 somewhat separate the location of the nostril locator 120 from the location of the mask 102, which may cause the mask 102 to displace somewhat 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 the sides of the user's nose to further form a seal. The wings 130 also support the position of the mask.

[0070] 4, when the interface 100 is worn, the mask 102 can be opened by spreading the wings 130 to increase the angle between them. When the wings 130 are pulled open, the nostril locators 120 (see FIG. 3), which are positioned on the proximal wall 124, lie better towards the user and guide the position of the mask 102 on 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 loop vertically around the user's head above the ears. Other techniques for wearing the interface can also be used.

[0071] As noted above, when donning the interface 100, it is preferred that the seal 114 folds or unfolds to improve fit and aid in achieving the desired positioning. However, in the configuration of Figures 1-4, unfolding the seal 114 generally requires positioning fingers between the seal 114 and the user's face, which can be cumbersome for the user. Additionally, it can be difficult to unfold the seal 114 with one hand and use the other hand to hold the strap 104 in place.

[0072] Referring to FIG. 5, an interface 100a is shown with a seal handling assembly 140. For clarity, the lower frame 116a of FIG. 5 is removed and an enlarged view of the seal 114a of the interface 100a is shown coupled to the upper frame 116a of FIG. 5. The seal handling assembly 140 preferably includes a pair of pads 142. The pads 142 extend outwardly from the seal 114a. In some configurations, the pads 142 are positioned along the distal surface 122a. In some configurations, the pads 142 extend outwardly from the distal surface 122a. In some configurations, the pads 142 are integrally formed with the seal 114a. In some configurations, 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. Seal 114a underlies frame 116a in the area of ​​pad 142. In some configurations, seal 114a is not secured to frame 116a in or proximal to the area of ​​pad 142 such that seal 114a can move relative to frame 116a.

[0073] The pads 142 are connected to an actuation mechanism of the seal manipulation assembly 140. In some configurations, the pads 142 are connected to scissor arms that extend into the seal 114a. The scissor arms may be crossed and hinged such that squeezing the pads 142 toward each other may move the ends 146 of the seal 114a away from each other.

[0074] In some configurations, the actuation mechanism is simpler than the scissor mechanism just described. For example, referring to FIG. 6, which is a simplified illustration of an actuation mechanism, the pad 142 is connected to or integrally formed with an arm 150. The arm can extend toward the end 146 of the seal 114a. The length of the arm 150 can be longer than the length of the pad 142. The forward portions of the arm 150 can be held apart using a cross member 152. In some configurations, the material of the seal 114a, the frame 116a, or the combination of the seal 114a and the frame 116a can be sufficiently stiff that the ends 146 of the seal 114a can be separated or spread apart by manipulating the pad 142 without including the cross member 152. By holding the arm 150 apart in a position between the pad 142 and the end 146, the pad 142 is forced toward each other, causing the ends 146 to move apart. Depending on the configuration, the arms 150 may be connected together by living hinges, by rigid connections to flexible cross members that resiliently deform, by pin joints, or the like.

[0075] By manipulating the shape of the uninflated seal 114a (e.g., by moving ends 146a apart to change the initial appearance of seal 114a to the user), seal 114a is opened for placement on the user's face. Once in place, seal 114a can be expanded, causing it to expand around the user's nostrils.

[0076] 7, an alternative seal 114b is illustrated. The seal 114b is provided with an alternative seal operating arrangement 140b. In the illustrated seal 114b, the seal operating arrangement 140b may be attached to or integrally formed with a portion of the distal wall 122b. The seal operating arrangement 140b is preferably positioned along the distal wall 122b along the lateral portion 110b or the wing 130b.

[0077] The seal operating configuration 140b may have any suitable configuration. In some configurations, for example, but not limited to, the seal operating configuration 140b includes walls 154 that may define a loop of material through which a finger may be inserted. In the illustrated configuration, the seal operating configuration 140b includes pockets 156. Each pocket 156 may have an edge 160 at a distal end. The edge 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 open. In the illustrated configuration, the proximal end of each pocket 156 is closed.

[0078] In some configurations, the surface feature 158 can be adjacent the opening defined by the edge 160. The surface feature 158 can be a recess or a surface texture. The surface feature 158 can be positioned just in front of the opening to guide the finger to the desired location. The surface feature 158 can provide additional clearance to facilitate finger insertion.

[0079] By positioning pocket 156 outside seal 114b, fingers can be inserted into pocket 156 and used to exert an outward force on wings 130b to open seal 114b against the face.

[0080] 8, the mask 102c can have a seal 114c featuring integral arms 170. In the illustrated configuration, the arms 170 can extend along an outer portion of the distal wall 122c. When the arms 170 are incorporated into the seal 114c, the frame 116 can be omitted and incorporated directly into the seal 114c or can remain a separate support element. When incorporated into the seal 114c, the mask frame 116 can be defined by areas of increased stiffness (i.e., areas of less flexibility). For example, when incorporated into the seal 114c, features of the mask frame 116 can be replaced with areas of increased thickness or overmolded properties.

[0081] In the illustrated configuration, integral arms 170 extend proximally from a distal region of distal wall 122c. Each end 146c is preferably separate from its associated arm 170 such that end 146c may move without significant movement of the overlying portion of arm 170. That is, the connection between arm 170 and distal wall 122c may terminate distal to end 146c such that at least a portion of arm 170 overlies but is not directly connected to the proximal end of distally facing wall 122c.

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

[0083] 9A-9F illustrate a seal 114d having a different surface texture 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. In some configurations, the surface texture can be positioned along a proximal portion of the proximal wall 124d. In some configurations, the surface texture is simply positioned along a proximal portion of the proximal wall. In some configurations, the surface texture can be positioned on other surfaces, but for the proximal wall 124d, the surface texture is simply positioned proximal to any nostril locators 120d.

[0084] 9A-9F show surface textures for slots 176, recesses 180, scallops 182, plateaus 184, and ribs 186. Any other suitable surface textures, including shapes, recesses, and protrusions, may be provided on proximal wall 124d of seal 114d. In some configurations, combinations of surface textures may be used, including, but not limited to, those described herein.

[0085] In some configurations, the textured portion is positioned outside of the nostril locator 120d. In some configurations, the textured portion is positioned completely outside of the nostril locator 120d. In some configurations, the textured portion can be positioned surrounding, substantially surrounding, or substantially adjacent to the nostril locator 120d. In such a position, the textured portion can reduce the contact surface area with the user's skin while still maintaining an adequate seal against the user's face. By reducing the contact surface area between the user's face and the seal 114d, the user will perceive the contact area as cooler. In some configurations, the textured surface can improve comfort without significantly degrading the seal that exists between the seal 114d and the face, because other areas define the first seal with the face in addition to the area with the textured surface.

[0086] The interface shown in Figures 1-4 is a structure incorporating both the seal 114 and the nostril locator 120 in a single component. Now referring to Figures 10-12, the interface may also include a mask with separable nostril locators and seals. By making the seal and one or more of the nostril locators separable, the mask may be better adapted for use by users with different face shapes. For example, the separable components may vary in size. In some configurations, the inflated seal may be common and the nostril locators may be interchangeable depending on the size desired by the user. In some configurations, the seals could be provided in different shapes, such as, but not limited to, wide and narrow versions.

[0087] 10, the illustrated interface 100e includes a seal 114e that includes a separable nasal insert 190 and a seal member 192. The seal 114e is formed from two or more components, but the seal 114e may otherwise be constructed in a generally similar manner as the seal 114 shown in Figures 1-4 and described above. For example, the seal 114e may be constructed with more flexible and less flexible regions similar to the seals disclosed above.

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

[0089] The body 196 includes a plug portion 200 and the seal member 192 includes a socket portion 202. The plug portion 200 may be received within the socket portion 202 as shown by the arrow in FIG. 10. In some configurations, the plug portion 200 is fixed in place within the socket portion 202. In some configurations, the plug portion 200 is fixed within the socket portion 202 by a friction fit. Other suitable techniques for securing the plug portion 200 and the socket portion 202 may also be used.

[0090] A distal end 204 of the body 196 includes an inlet opening, and proximal to the inlet opening, the body 196 includes one or more openings 206. The inlet opening may be coupled to the flexible supply conduit 106. The seal member 192 includes one or more internal voids or openings 208 that may be in fluid communication with the one or more openings 206 when the plug portion 200 is positioned within the receptacle portion 202. Thus, in the configuration of FIG. 10 , gas flows from the flexible conduit into the nasal insert 190, a portion of the gas flows from the nasal insert 190 into the seal member 192, and a portion of the gas flows from the nasal insert 190 through the nostril locators 194 to the user.

[0091] 11, the nasal insert 190a and the seal member 192a can combine to define a mask. The nasal insert 190a can 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 seal member 192a can have a distal inlet (not shown) that connects directly to a supply conduit (i.e., connects to a 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 an opening as used in the configuration of FIG. 10, but is not required. Thus, in the configuration shown in FIG. 11, gas is first supplied to the seal member 192a, which delivers the gas to the nasal insert 190a through an 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]

[0013] Referring now to Figure 12, further multi-piece seal structures are described. The multi-piece structure allows for customization of the seal for the user. For example, different sized nostril locators can be used with a common seal member or different sized seal members. Additionally, nostril locators of different hardness or stiffness can be used and / or seal members of different levels of hardness can be used. In some configurations, the seal member and nostril locator can be formed from the same material. In some configurations, the seal member and nostril locator can be formed from different grades of the same material.

[0093] The seal member 192b shown in FIG. 12 includes one or more exit openings 208 formed on a proximal surface. In the illustrated configuration, the seal member 192b includes two openings 208 that receive individual nostril locators 210. The openings 208 can define receptacles and the distal ends 212 of the nostril locators 210 can define plugs. As shown in FIG. 12, the distal ends 212 fit into the openings 208. The nostril locators 210 can be coupled to the seal member 192b in any suitable manner. In some configurations, the nostril locators 210 can be friction fit into the openings 208. In some configurations, the distal ends 212 and the openings 208 can be configured to couple in only one rotational direction. In some configurations, the rotational direction can be varied to customize the fit of the nostril locators 210. In some configurations, the relative rotational orientation of the opening 208 and nostril locator 210 may be indexable such that the two can be rotationally adjusted and fixed in a desired rotational position.

[0094] 13, a seal 214 is shown featuring a separable nasal insert 216 and a seal member 218. The seal 214 may resemble the structure of any of the configurations described above. In some configurations, however, the nasal insert 216 includes an auxiliary component 220. As shown in FIG. 10, the auxiliary component 220 may be positioned between one or more nostril locators 222 and a base 224 of the nasal insert 216. In some configurations, a rim 230 may surround the one or more nostril locators 222 and the auxiliary component 220 may be positioned between the rim 230 and the base 224. In some configurations, the rim 230 may be positioned between the one or more nostril locators 222 and the auxiliary component 220. In the illustrated configuration, the base 224 of the nasal insert 216 may include one or more openings 226, but need not.

[0095] As noted above, the seal member 218 can be flexible. In the illustrated configuration, the seal 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 sufficiently flexible to allow the auxiliary component 220 of the nasal insert 216 to be inserted into a pocket defined in the wall of the seal member 218. In some configurations, the opening 228 seals around a portion of the nasal insert 216 between the auxiliary component 220 and the rim 230.

[0096] The edge 230 and the auxiliary component 220 can be separated by, for example, but not limited to, a gap, recess, channel, or groove. The seal member 218 can include a lip that is received within a gap, recess, channel, or groove that can be defined between the edge 230 and at least a portion of the auxiliary component 220. That is, the auxiliary component 220 can overhang and separate from at least a portion of the edge 230. The gap between the auxiliary component 220 and the edge 230 can be sized and configured to receive at least a portion of the seal 214. In this manner, the seal member 218 and the nasal insert 216 can be secured together, for example, but not limited to. Additionally, in the illustrated configuration, the seal member 218 and the nasal insert 216 can be sealed together.

[0097] 14A-14D, a sampling of different configurations of auxiliary components will be described. A nasal insert 216a is shown in FIG. 14A, where the auxiliary component 220a includes a slightly curved blade member 232. The blade member 232 extends laterally outward beyond the nostril locators 222a and beyond the outermost extent of the edge 230a that generally surrounds the nostril locators 222a. The blade member 232 can be integrally formed with the nasal insert 216a, or can be formed separately from the nasal insert 216a and secured to the nasal insert 216a in any suitable manner. In some configurations, the blade member 232 is formed from silicone. The blade member 232 can be a resilient member that can bend into a first position and a second position. In some configurations, the blade member 232 can be a member that is bidirectionally stable. That is, the blade member 232 can assume two distinct positions that have sufficient stability to remain in those positions at least temporarily. In some configurations, the blade members 232 have sufficient resilience to assume a first shape or position when the associated seal member 218a is under-expanded or not expanded. In some configurations, the blade members 232 bend or flex when the associated seal member 218a expands for use. Such a configuration is shown in FIG. 14A, where the outermost portions of the blade members 232 are flexed upward.

[0098] As shown in FIG. 14A, the blade member 232 provides additional material in contact with one or more inner surfaces of the seal member. The blade member 232 can be configured to assist in attaching the mask to the user's face by forcing the seal member 218a to an open position and allowing it to flex while the user is using the interface. By slightly opening the mask, the nostril locators 222a can more easily mate with the nostrils. When gas pressure is provided to the seal member 218a, the seal member expands and bulges into sealing engagement with the user's face. The blade member 232 is preferably flexible enough that when the seal member 218a begins to expand, the blade member 232 can flex and conform to the shape of the seal member 218a so that the seal member 218a can expand and seal around the user's nose.

[0099] FIG. 14B illustrates a nasal insert 216b that is similar in some respects to the nasal insert 216a illustrated in FIG. 14A. The edge 230b of the nasal insert 216b in FIG. 14B includes a loop member 234. The loop member 234 is similar in some respects to the blade member 232. However, the loop member 234 extends both proximally and distally, as well as laterally outward. That is, as is evident from comparing FIG. 14A with FIG. 14B, while the blade member 232 is a generally flat, dish-shaped component in FIG. 14A, the loop member 234 is not as flat and extends both forward and backward. Thus, the loop member 234 facilitates manipulation of the proximal portion of the associated seal member 218b, and facilitates manipulation of the distal portion of the seal member 218b. That is, blade member 232 may contact the inner surface of the distal portion of the seal member, and loop member 234 may contact the inner surfaces of the proximal and distal portions of seal member 218b.

[0100] 14B, the loop member 234 extends laterally outwardly of the nostril locator 222b and beyond the outermost extent of the edge 230b. The loop member 234 may be integrally formed with the nasal insert 216b or may be formed separately from the nasal insert 216b and secured thereto in any suitable manner. In some configurations, the loop member 234 may be formed from silicone.

[0101] By contacting the inner surface of the seal member 218b, the loop member 234 places the seal member 218b in an open position before the seal member 218b expands, giving the collapsed seal member 218b an initial shape. When gas pressure is supplied to the seal member 218b, the seal member 218b expands and bulges into sealing engagement with the face of the user. The loop member 234 is preferably flexible enough that it can bend and conform to the shape of the seal member 218b as the seal member 218b begins to expand, allowing the seal member 218b to expand and seal around the nose of the user. In some configurations, the loop member 234 can be switched between two positions. In some configurations, the loop member 234 can be configured to easily flex from the open or first position when the seal expands, but return to the open or first position when the seal re-deflates.

[0102] FIG. 14C illustrates a nasal insert 216c having an auxiliary component 220c that is inflatable. The auxiliary component 220c includes one or more stabilizers 236. The stabilizer 236 can have one or more outer walls and can be inflatable. Thus, an internal pocket defined within the stabilizer 236 can be in communication with a gas source, such as flow through an associated seal member 218c. In the illustrated configuration, the stabilizer 236 can be coupled to the base 224c of the nasal insert 216c. The inflated stabilizer 236 can provide a force that presses the proximal surface of the seal member against the user's face upon actuation pressure. Thus, unlike the loop member 234 and the blade member 232, the inflated stabilizer 236 does not serve to hold the uninflated mask in an open position. The stabilizer 236 provides an improved sealing force during use.

[0103] Referring to FIG. 14D, a nasal insert 216d is shown with an auxiliary part 220d that can bend between a first position P1 and a second position P2. The auxiliary part 220d can include a dish member 238 that is stable in a first position P1 and a second position P2. In some configurations, the dish member 238 can be flipped between the first position P1 and the second position P2, but returns to the first position P1 with minimal force. As shown in FIG. 14D, the dish member 238 can be bent to the second position P2 to don the mask. When the dish member 238 is in the second position P2, the seal member 218d can be held in an open position. When positioned on the user as required, the dish member 238 can be pressed slightly against the user's face to quickly return the dish member 238 to the first position P1, which allows the seal member 218d to move to a more closed position.

[0104] Thus, to wear a mask with the assembly shown in FIG. 14D, the dish member 238 can be bent from a first position P1 to a second position P2. When the mask is positioned such that the nostril locators 222d can be positioned within the user's nares, the dish member 238 is temporarily stable in the second position. When the mask is engaged with the user's face, a force is transferred to the dish member 238 via the seal member 218d, causing the dish member 238 to quickly return or return to the first position P1. When the dish member 238 is in the first position, the seal member 218d can surround the tip of the user's nose, thereby allowing a mask with the assembly shown in FIG. 17 to seal around the tip of the user's nose.

[0105] 15A, a portion of a seal member 250 is shown. The seal member 250 may be configured according to any combination of features of any of the structures described herein, for example, but not limited to, the seal member 250 may include a distal wall 252 and a proximal wall 254. An opening 256 may be defined in the distal wall 252. A supply of gas may enter the seal member 250 through the opening 256.

[0106] 18, the distal wall 252 can have a thicker cross-section compared to, for example, the proximal wall 254. The thicker cross-section provides the distal wall 252 with a higher stiffness compared to the proximal wall 254. In some configurations, the material used can have a higher stiffness, but the wall thickness can be the same. In some configurations, both the thickness and stiffness of the material can be used to provide different degrees of stiffness.

[0107] 15A, the nostril locator 260 may be positioned along the proximal wall 254. The illustrated nostril locator 260 may generally taper narrowing toward a proximal opening 262. As such, the proximal opening 262 may have a smaller diameter than the distal opening into the nostril locator 260. In general, the nostril locator 260 may 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 configuration shown in Figures 15A-15D shows a support structure that is integrated into the structure of the seal member 250 itself. Referring to Figures 15A-15C, a support structure 270 is shown that is integrated into the seal member 250. With the integral support structure 270, the mask is more comfortable than other masks that may use a separate support structure that is stiffer than the seal member. Additionally, the integral design provides better support for the seal member 250 since the support structure 270 can be directly adjacent to the user's face.

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

[0110] By molding the support structure 270 to the seal member 250, the support structure can flex with the seal member 250. By flexing the seal member 250, the seal member 250 can better conform to different face shapes. Additionally, the support structure 270 can move with the seal member 250, allowing the seal member 250 to be positioned closer to the face. Additionally, by incorporating the support structure 270 into the seal member 250, the incorporation of the support structure 270 into the seal member 250 simplifies the manufacture of the mask, since the support structure is not formed separately or by an overmolding process. Additionally, this incorporation reduces the weight and facilitates a reduced size of the assembly.

[0111] 15A-15C, the illustrated support structure 270 is a crescent-shaped member that is generally below the seal member 250. Referring to FIG. 15D, in some configurations, the support structure 270 can wrap upward along one or more of the outer (distal) sidewalls 252. Thus, as illustrated, the support structure 270 can be provided in a variety of shapes. Because the support structure 270 can be molded in a one-piece construction, the shape of the support structure 270 can be adjusted to support the seal member 250 whenever needed. The configurations of FIGS. 15A-15C show the structure providing support directly above the lip area of ​​the user, while the configuration of FIG. 15D relocates the support above the lips and in the cheek area other than the rather narrow area below the nose. Thus, in the configuration of FIG. 15D, the support moves outward toward the cheek, away from the upper lip. 15D , the support remains approximately in the bottom half of the seal member 250 as the support structure 270 wraps vertically upward along the sidewall. Varying the position of the support structure 270 can improve the comfort of the seal member 250 as well as improve the performance of the seal member 250.

[0112] 16-18, another mask seal member 280 is shown. The mask seal member 280 includes a distal wall 282 and a proximal wall 284. One or more nostril locators 286 may be positioned on at least a portion of the proximal wall 284. The nostril locators 286 may have any suitable configuration. In some configurations, the nostril locators 286 taper upwardly to an opening 288.

[0113] As shown in FIG. 17, the proximal wall 284 wraps proximally around the nostril locator 286. Additionally, the illustrated nostril locator 286 spans a portion of the proximal wall that is generally perpendicular to the perpendicular bisection plane P, as well as a portion of the proximal wall 284 that wraps proximally. Other configurations are possible. In the illustrated configuration, the proximal wall 284 extends proximally beyond a proximal majority of the nostril locator 286. The seal member 280 has a laterally extending portion 290 that wraps proximally, such that the laterally extending portion 290 may hold the nostril locator away from the nostrils for flatter user face shapes. To help provide improved flexibility, the seal member 280 may be reinforced in areas closer to the nose compared to the cheeks.

[0114] 16, the seal member 280 can include an edge surface 292 connecting the proximal wall 284 to the distal wall 282. The edge surface 292 in the illustrated configuration is wider at the bottom than at the top. As shown, the edge surface can provide a wider width at the bottom of the illustrated seal member 280. The seal member 280 can have a thicker wall at the bottom corner and the proximal wall 284 can be thinner in the area surrounding or at least partially surrounding the nostril locator 286. The thicker area at the bottom corner can extend upward and follow the generally vertical line illustrated in FIG.

[0115] The majority of the entire seal member 280 may be configured to bulge, with the thicker regions being configured to bulge less than the less thick regions. The thicker regions may help control the bulging, such that the proximal surface receives the majority of the bulging compared to the edge surface 292 and distal surface 282. Thus, the areas surrounding the nostril locators 286 may bulge more, while the bottom corners bulge less, which increases comfort and improves the seal of the mask.

[0116] Referring again to FIG. 3, the nostril locator 120 is typically configured to be positioned within the nostril. The nostril locator 120 can be made rigid enough to resist crushing during use in order to fit within the user's nostril. As such, the proximal end of the nostril locator 120 has been found to slightly pinch the septum or otherwise reduce comfort for the user. Thus, it may be desirable to remove some of the stiffness of the nostril locator 120, particularly the proximal end of the nostril locator 120, and / or the transition locations between the nostril locator 120 and surrounding structures (described below with reference to FIGS. 29-42).

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

[0118] In some configurations, the edge 308 defining the opening 306 is generally elliptical, as shown in FIG. 19, and includes a longer axis L1 and a shorter axis L2. In such configurations, the interruption 310 may intersect the longer axis L1. In some configurations, one or more interruptions 310 may be positioned along a 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, the single interruption 310 may be positioned closer to the apex of that portion of the elliptical opening 306. In some such configurations, the single interruption 310 may intersect the longer axis L1. In some such configurations, the single interruption 310 may be centered on the longer axis L1.

[0119] 19, the interruptions 310 define recesses in the nostril locator 302 that extend from the rim 308 into the material of the nostril locator 302. The interruptions 310 may extend any suitable distance along the length of the nostril locator 302. The length is preferably long enough to allow some radial escape to the rim 308 without being so long as to create a leak path. As the length of the interruptions 310 increases, the stiffness of the nostril locator 302 becomes softer.

[0120] 20A-20E, other configurations of the interruptions 310 are shown. As shown, the interruptions 310 can have many different shapes and can be moved away from the area of ​​the nostril locator 302 that contacts the septum. As shown, there can be as few as one interruption 310 or as many as desired. In some configurations, the interruptions 310 are serrated ends of the nostril locator 302. Other configurations are possible.

[0121] 21 and 22, a sealing member 330 is shown. The sealing member 330 can have features, aspects and characteristics in common with any other configurations described herein. In the illustrated configuration, the sealing member 330 includes at least one flexible prong 332. In some configurations, the sealing member 330 can include two flexible prongs 332. The flexible prong 332 includes a distal end coupled to a proximal face 334. The flexible prong 332 can extend generally proximally from the proximal face 334. The flexible prong 332 can have one or more openings 336 positioned generally at the proximal end of the prong 332. In the illustrated configuration, the openings 336 can form slits extending generally perpendicularly through the proximal-most end.

[0122] The prongs 332 preferably include a stalk 340 that extends generally between the proximal face 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 prongs 332 that couple at least a portion of the prongs 332 to the sealing member 330 can be reduced. In some configurations, different materials or grades of material can be used to provide increased mobility to the prongs 332.

[0123] In the illustrated configuration, the prongs 332 can be configured to telescope or expand / contract, as shown by comparing Figures 21 and 22. By configuring the prongs 332 to expand, the prongs 332 can have high flexibility. As shown, the prongs 332 can be compressed along the axial direction. The compression can allow the prongs 332 to improve comfort when sealing against the user's nares.

[0124] In some configurations, the prongs can be configured with a bellows-type shape. The bellows-type shape can provide axial compressibility. The pleated appearance of the bellows-type shape can be formed along all of the stalk 340 or only a portion of the stalk 340. By providing a bellows-type shape, the stalk 340 also allows the proximal end of the prong 332 to swing about 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] 23A-23C, a portion of a sealing member 350 is shown. In some configurations, the sealing member 350 includes a nostril locator 352 similar to that described above. At least a proximal portion of the nostril locator 352 may be partially or completely covered by an end member 354, as shown in each of FIGS. 23A-23C. The end member 354 may be formed from a material that is as soft as the material of the nostril locator 352, or softer. In some configurations, the end member 354 may be partially or completely formed from a softer silicone material. That is, the use of the end member 354 may provide increased comfort by positioning it over the proximal end of the nostril locator 352.

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

[0127] 24, a further seal member 360 is shown. The seal member 360 includes a multi-walled nostril locator 362. In the illustrated configuration, the nostril locator 362 includes a thin outer wall 364 and a thicker inner wall 366. In some configurations, the outer wall 364 is spaced from the inner wall 366 to allow relative movement between the two walls. In some configurations, the inner wall 366 may terminate within the outer wall 364. That is, the outer wall 364 may extend further proximally relative to the inner wall 366.

[0128] The inner wall 366 may comprise, for example, but not limited to, a foam or gel insert. The inner wall 366 underlies and supports the outer wall 364. Thus, the outer wall 364 could be formed from a very thin layer with the support of the separately formed inner wall 366. In some configurations, the outer wall 364 may be a very thin silicone wall that is intermittently or substantially completely supported by the inner wall 366, which may be a much softer material than the outer wall 364.

[0129] 25A and 25B, a seal member 380 is shown therein. The seal member 380 can include one or more nostril locators 382. In some configurations, the seal member 380 can be configured such that the nostril locators 382 direct the airflow in a more upward direction. In FIG. 25A, a nostril locator 382 is shown directing the airflow more posteriorly as compared to the nostril locator 382 shown in FIG. 25B. By raising the rearmost wall (see 384) of the nostril locator, for example, the trajectory of the airflow can be changed to a more upwardly directed flow. In some configurations, the nostril locator is configured such that the resulting airflow is more upward and forward. By redirecting the airflow in this manner, the airflow does not blow directly into the nose, thereby improving the comfort of the user. In some configurations, the nostril locator 382 can be positioned, for example, but not limited to, on a ball joint to allow the user to adjust the airflow as needed.

[0130] Referring now to FIG. 26, the illustrated seal member 400 can be configured in any of the configurations described above. The illustrated configuration, however, 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 with openings 404 formed in the proximal surface 402. Thus, the user's naris can easily overshoot the openings 404 formed in the proximal surface. The configuration of FIG. 27 shows a single opening 404 that may be under one or both nostrils of the user, while the configuration of FIG. 28 also shows a single protrusion 406 that may help indicate to the user when the mask is properly positioned under the nose. Referring to FIG. 28, in some configurations, the tip of the nose may be located at the intersection 408 of the two facet lines. The protrusion 406 may be a short nostril locator, a complete nostril locator, or any other suitable structure to assist the user in confirming that the mask's sealing member is positioned as desired relative to the nostrils. In some configurations, the nose may fit within or around the opening and the sealing member may bulge around the user's nose. For example, the tip of the nose may enter the opening or the opening may be located below the tip of the nose to seal. The bulge improves the seal of the sealing member, especially if nothing extends into the user's nostrils.

[0131] 29-42, a further interface assembly 420 is shown arranged and configured in accordance with certain features, aspects and advantages of the present invention. The interface assembly 420 generally comprises a frame or body 422 and a seal 424. The seal 424 may be removably secured to the frame 422 for use. In some configurations, multiple seals 424 may be provided for coupling to the frame 422, which may vary in size, shape, softness, or any other desired characteristic. In the illustrated configuration, the frame 422 provides attachment points for headgear or the like. Other configurations are possible.

[0132] The illustrated seal 424 incorporates a coupling or attachment assembly 426 that can be joined to a flexible seal member 428. With reference to FIG. 30 , the seal member 428 includes a proximal surface 430 (i.e., the surface closest to a user's face in use) and a distal surface 432 (i.e., the surface furthest from a user's face in use). In the illustrated configuration, the distal surface 432 defines an inlet opening 434. The opening 434 is configured to allow respiratory gases to enter a chamber defined within the seal member 428.

[0133] In the illustrated configuration, the opening 434 is circumscribed by a rib or protrusion 436. The rib or protrusion 436 is best seen in the cross-sectional view of FIG. 34. As shown, the portion of the seal member 428 connecting the rib or protrusion 436 to the distal face 432 can extend generally perpendicular or generally perpendicular to the axis of the inlet opening 434. Thus, the rib or protrusion 436 is offset inwardly by a portion of the distal face 432. The radial offset allows the rib or protrusion to be captured by the mounting assembly 426. Other configurations are possible, keeping in mind the need for a more rigid mounting assembly 426 to project onto the surface of the seal member 428.

[0134] The mounting assembly 426 can be more rigid than the seal member 428. In some configurations, the mounting assembly 426 can be formed as a two-piece structure. For example, the mounting assembly 426 can capture the seal 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 can have a sleeve 442 extending through the inlet opening 434. The sleeve 442 can interface with a larger radius ridge 444. The larger radius ridge 444 can provide a location against which the rib or protrusion 436 of the seal member 428 can rest. The sleeve 442 can be externally threaded or can include one or more external protrusions 444. The sleeve 442 can also include an internal coupler structure 446. The external threads or protrusions 444 can mate with structure formed on the inner surface of the outer member 440. The outer member extends radially outward enough to capture the rib or protrusion 436 of the seal member 428 between the outer member 440 and the inner member 438. In this manner, the mounting assembly 426 can be secured to the seal member 428.

[0136] As noted 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 such that the seal 424 (i.e., the seal member 428 and the mounting assembly 426) can be secured to the frame 422 for use and removed for replacement. The frame 422 can have a flange or the like to which the mounting assembly 426 can be connected. In the illustrated configuration, the inlet portion of the frame 422 (i.e., the socket for connecting the ball and socket) can incorporate a recess, while the mounting assembly 426 can incorporate a ridge, although other suitable structures can be used, keeping in mind that this is a sufficiently solid connection for use and that a removable connection is desired for replacement of the seal 424.

[0137] In some configurations, the frame 422 and the mounting assembly 426 may include orientation features. For example, in the illustrated configuration, the mounting assembly 426 may incorporate a lug, protrusion, or boss feature 448 and the frame 422 may incorporate a groove, recess, or relief feature 450. Alignment of the lug 448 with the groove 450 may confirm a desired orientation between the seal 424 and the frame 422. Other suitable configurations may be used, keeping in mind the need to obtain precise alignment and confirmation of the orientation of the seal 424 relative to the frame 422.

[0138] 35-42, one preferred construction of the seal member 428 will now be described in more detail. As has been described, the seal member 428 can have regions of greater flexibility and regions of greater stiffness. These regions can be from different materials, different grades of the same material, or different thicknesses. In the illustrated configuration, there are regions of different thicknesses. The thickest regions on the proximal surface 430 (shown in FIGS. 35-37) and the thickest regions on the distal surface 432 (shown in FIGS. 38-40) can be seen at the ribs or protrusions 436 surrounding the inlet opening 434 and in the central portion of the wings 452. These regions are the areas used for attachment and gripping, and therefore are desirably the thickest and most stiff regions. Additionally, as will be described in more detail below, the thickest regions, at least in the wing regions 452, can support the thinner regions, providing some structure to the seal member 428. In some configurations, the thickness is 3.0 mm, and in some variations this area can be slightly larger or smaller, keeping in mind that you want it to be rigid enough for mounting and gripping.

[0139] The next thickest region is the bond region 454 which bonds the rib or protrusion 436 to the valance of the seal member 428. This region is simply thick enough to resist tearing of the seal member 428 at the juncture of the rib or protrusion 436 and the valance of the seal member 428. In some configurations, the bond region 454 is approximately 1.0 mm thick, although in some variations it can be slightly larger or smaller, keeping in mind the need to reduce or eliminate the possibility of tearing during normal use.

[0140] As described above, the nostril locator 456 may be positioned on the proximal surface 430. The nostril locator 456 is desirably flexible enough to reduce or eliminate the possibility of causing irritation. The nostril locator 456 is also desirably rigid enough to reduce the possibility of bulging or insufficient self-support and to indicate to the user the correct location and orientation of the seal 424 relative to the face. The nostril locator 456 is preferably rigid enough to inhibit or prevent significant collapse upon positioning of the locator 456 within the user's nostril. In some configurations, the thickness of the nostril locator 456 may be approximately 0.7 mm, and in some variations may be slightly larger or smaller, keeping in mind the need to reduce discomfort to the user while still aiding in positioning the mask.

[0141] As noted above, certain regions of the seal member 428 may be configured to bulge, expand, etc. By having such an expandable surface, the seal member 428 may provide a more effective seal while accommodating slight movement of portions of the seal member 428 relative to the user's face during use. In fact, the nostril locators 456 may be somewhat separated from the frame 422 through the most flexible regions of the seal member 428, which surround the nostril locators 456 and are separated from the balance of the mask in the illustrated configuration. Thus, the perimeter region 458 may be defined to generally surround the nostril locators 456. The perimeter region 458 may extend to the transition between the proximal surface 430 and the distal surface 432. In some configurations, the thickness of the perimeter region 458 is approximately 0.25 mm, and in some variations may be slightly larger or smaller, keeping in mind the need to provide some separation between the relatively stiff nostril locators 456 and the balance of the seal member 428.

[0142] Other than the areas specified, the remainder of the illustrated seal member 428 may be transitions in wall thickness within the wall thicknesses specified. The illustrated seal member 428 is merely one desired configuration and certain variations are possible.

[0143] As noted above, and particularly as shown in FIG. 41 , the side portions or wing regions 452 can include reinforcing regions in the form of thickened regions 470 that support thinner regions of the body of the seal member 428, such as the perimeter region 458. The thickened regions 470 can be mirror images of one another, as can the wing regions 452, such that the seal member 428 has symmetry about a vertical center plane. The thickened regions 470 can extend along a significant portion of the length and / or height of the wing regions 452 or the seal member 428. In the illustrated configuration, the thickened regions 470 extend substantially the entire length and substantially the entire height of the wing regions 452, and the wing regions 452 can extend substantially the entire height and substantially the entire length of the seal member 428. Thus, in some configurations, the thickened regions 470 are essentially the same size and shape as the distal surface 432 of the wing regions 452.

[0144] The thickened region 470 may be of a substantially constant or variable thickness. In the illustrated configuration, the peripheral or edge portions of the thickened region 470 are of reduced thickness relative to a central portion of the thickened region 470. In particular, the forward edge portion of the thickened region 470 is of reduced thickness relative to adjacent and / or central portions, as well as to the junction region 454 and the transition to the rib 436, to accommodate the mounting assembly 426. The thickness of the forward edge portion of the thickened region 470 is preferably greater than the junction region 454, at least up to the junction between the thickened region 470 and the junction region 454. In the illustrated configuration, the forward edge portion of the thickened region 470 gradually decreases in thickness toward the junction with the junction region 454.

[0145] Similarly, the trailing edge portion of the thickened region 470 also has a reduced thickness relative to adjacent and / or central portions of the thickened region 470. This configuration maintains flexibility at the trailing edge portion of the proximal surface 430 while limiting or preventing significant bulging or expansion at the trailing edge portion of the distal surface 432. Advantageously, this configuration allows the seal member 428 to provide sufficient sealing functionality against the exterior portion of the user's nose while limiting or avoiding any significant bulging at the trailing edge portion of the distal surface 432, thereby providing a sense of stability to the user.

[0146] 41, the trailing edge of the seal member 428, which may also be referred to as an edge or marginal surface, may include a transition portion 472 between the proximal surface 430 and the distal surface 432. In the illustrated configuration, the transition portion 472 includes a generally rounded or curved wall portion. As will be explained, in some configurations, the thickened region 470 begins to taper in thickness forward of the transition portion 472. However, to control bulging of the seal member 428 and preferably limit or prevent any significant bulging of the distal surface 432, it is preferred that the thickness of a portion of the transition portion 472 is greater than the soft proximal surface 430 or the surrounding region 458. In the illustrated configuration, the trailing edge portion of the thickened region 470 tapers in thickness relatively quickly toward the transition portion 472 and then tapers in thickness from the distal surface 432 to the proximal surface 430. In some configurations, transition portion 472 can have a portion that defines a wall thickness that is approximately the same as the thickness of flexible proximal surface 430 , such as peripheral region 458 .

[0147] As shown in Figures 29-31, 35, 36 and 38-40, among other cases, the lower rear corner of the wing region 452 includes an outward projection or outward projection cornice 474. The outward projection cornice 474 flares outward relative to an adjacent portion of the wing region 452 such that the outward projection cornice 474 is positioned laterally outward of the nose at a location generally corresponding to the cheek or upper lip of the user. In some configurations, the outward projection cornice 474 is located generally above the portion of the upper lip that overlies the canines of the user. The outward projection cornice 474 may help secure the seal member 428 to the face of the user. In some configurations, this configuration may provide a sufficient sense of stability to the user such that the seal member 428 is the only portion of the mask that contacts the user's face while omitting additional stability elements. The outward projection cornice 474 may at least partially convey the sense of stability to the user due to its relative stiffness. Thus, thickened region 470 preferably extends at least partially into outboard corner 474, and in some configurations may extend at least substantially completely through outboard corner 474. At least the rearmost and lowest portions of distal face 432 of seal 424 preferably include thickened region 470. Within outboard corner 474, thickened region 470 may taper in thickness into transition portion 472 described above.

[0148] As described above, the wing regions 452 can be used as gripping portions of the seal 424 for, among other things, initially positioning the mask on the face, repositioning the mask on the face, and removing or coupling the seal 424 to the frame or body 422. As described, the thickened regions 470 can facilitate gripping of the seal 424 on the distal surface within the wing regions 452 by limiting collapse of the seal 424 in response to a strong grip of the wing regions 452. In some configurations, the distal surface 432 of the seal 424 can include surface features (e.g., one or more recesses or protrusions) configured to facilitate gripping. Such features can be referred to as gripping surfaces or grips.

[0149] Each of the illustrated wing regions 452 includes a grip surface 480 formed by a protrusion 482. The protrusion 482 extends outwardly from the adjacent surface to an extent sufficient to provide some resistance to sliding of a user's finger along the surface of the seal 424. The illustrated protrusion 482 is generally crescent shaped, which defines a generally scallop-shaped grip surface 480. The ends of the protrusion 482 are positioned rearward of a central curved portion of the protrusion 482. A user's finger or thumb can be placed within the grip surface 480, and the user can press against the protrusion 482 when attaching the seal 424 to the frame or body 422. Thus, the protrusion 482 compensates for an inwardly tapered or curved shape of the seal 424 that would otherwise allow the user's finger or thumb to slide along the distal surface 432 of the seal 424. The gripping surfaces 480 and / or protrusions 482 may also assist a user in removing the seal 424 from the frame or body 422 or in positioning or repositioning the mask. Other suitable gripping configurations may also be provided, such as multiple protrusions, recesses, or other surface features that enhance grip against smooth surfaces. Materials or material treatments that improve gripping could also be used.

[0150] The seal 424 could alternatively or additionally include gripping surfaces or other features that define a grip. For example, with reference to FIGS. 29, 30 and 32, the seal 424 could 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 rearwardly projecting portion or tab of the outer member 440, and the grip 484 can extend rearward of an annular portion of the outer member 440 on the distal surface 432 of the seal 424. The seal 424 can define a recess that receives the grip 484, and an outer surface of the grip 484 can be aligned with an adjacent outer surface of the seal 424. The inner member 438 is generally aligned with the grip 484 but includes a rearwardly extending portion 486 within the interior space of the seal 424 to capture the seal between the grip 484 and the rearwardly 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 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, opposing pairs of grips 484 can be provided on the top and bottom and / or both sides of the seal 424. In some configurations, the gripping surface 480 and / or protrusion 482 can be defined by a rigid structure, such as a portion of the mounting assembly 426 (e.g., the outer member 440). In some configurations, the mounting assembly 426 can include a protrusion or other rigid portion that extends a substantial length and / or height of the wing region 452 of the seal 424.

[0152] As noted above, the nostril locators 456 may be at least somewhat decoupled from the balance of the seal member 428. In some configurations, the seal member 428 may be configured to preferentially move or favor preferentially move the nostril locators 456. In some such configurations, the seal member 428 may be configured to provide less resistance to tilting movement in at least one direction relative to at least one other direction. The seal member 428 preferably includes one or more features that cause or favor tilting the nostril locators 456 outwardly away from one another. That is, outward tilting of the nostril locators 456 preferably provides less resistance than tilting in one or more other directions (e.g., inward, upward, or downward). Such a configuration may reduce discomfort that may otherwise result if the nostril locators 456 pinch the septum of the user's nose. The configurations disclosed herein may be applied to other types of seals or patient interfaces, such as any configuration incorporating nasal pillows or other sealing or non-sealing prong-like nasal elements.

[0153] Any suitable configuration or structure may be used to allow or facilitate preferential movement of the nostril locator 456. In the illustrated configuration, the seal member 428 includes a thinned region extending around at least a portion of the nostril locator 456, which thinned region facilitates tilting or flexing of the nostril locator 456 and is referred to herein as a flex region 490. In some configurations, the flex region 490 is located within an annular transition portion surrounding the nostril locator 456 between the nostril locator 456 and the peripheral region 458. The transition portion may be formed partially or completely by a base portion of the nostril locator 456, by a portion of the peripheral region 458 adjacent to the base portion of the nostril locator 456, or by a combination of the two. In other configurations, the flex region 490 may be provided in another suitable location to allow the nostril locator 456 to preferentially flex.

[0154] In some configurations, the flexure region 490 is located on the base of the nostril locator 456, and in the illustrated configuration, is located substantially entirely on the base of the nostril locator 456. The flexure region 490 can comprise a thin wall section at the base of the nostril locator 456. The thin wall section has a thickness less than other portions of the nostril locator 456. In some configurations, the thin wall section defining the flexure region 490 can be the thinnest portion of the nostril locator 456. In some configurations, the wall thickness of the thin wall section is about half or less than the wall thickness of a substantial portion or remainder of the nostril locator 456. For example, in some configurations, the thin wall section at the flexure region is about 0.35 mm thick and at least a major portion of the nostril locator 456 is about 0.8 mm thick. In some configurations, the tip of the nostril locator 456 is thin for comfort. However, if flex region 490 is provided, the tip may be of the same or substantially the same wall thickness as the rest of nostril locator 456 to improve user feedback, reduce collapse upon insertion into the nostril, and be comfortable during use. The thinner walled section defining flex region 490 may have a greater thickness than the surrounding region 458.

[0155] The flexure region 490 preferably extends around only a portion of the circumference of each of the nostril locators 456. In some configurations, the flexure region 490 is limited to about one-half or less of the circumference of the nostril locators 456. In some configurations, the flexure region 490 is limited to the outside of the circumference of the nostril locators 456. In the illustrated configuration, the flexure region 490 extends around more than about one-third but less than about one-half of the circumference of each of the nostril locators 456.

[0156] With particular reference to FIG. 42, the exit apertures 492 defined by the nostril locators 456 are generally elliptical, each defining a major axis 494 along the maximum width of the exit aperture 492, and a minor axis 496 perpendicular to the major axis 494. In some configurations, the flexure region 490 is substantially or completely confined to one side (e.g., outboard) of the major axis 494. The lower end of the flexure region 490 can be at or near the major axis 494, and the upper end of the flexure region 490 can be spaced away from the major axis 494. Such a configuration can tilt in an outward and slightly downward direction relative to the major axis 494. The length and / or location of the flexure region 490 can be altered to impart tilt or deflection in a desired direction. In some configurations, assuming the lower end of the major axis 494 is at 0 degrees, the flexure region 490 can extend from about 5 degrees to about 150 degrees.

[0157] At least in part because of the provision of the flexure region 490 and other features described herein, the shape of the seal member 428 of Figures 29-42 modifies the shape of the nasal seal currently commercialized by the applicant, Fisher & Paykel Healthcare Limited, in the Pilairo® nasal mask. For example, the axis 494 is rotated vertically by approximately 10 degrees relative to the orientation of current Pilairo® nasal masks. The axis 494 is oriented at an angle of approximately 20 degrees to 25 degrees relative to a vertical central plane passing through the seal member 428, and the lower end of the axis 494 is much further outboard (further from the central plane) than the upper end of the axis 494. The surface defining the tip of the nostril locator 456 is rotated outward by approximately 4 degrees relative to the current Pilairo® nasal mask, so that the surface defines an angle of approximately 20 degrees to 25 degrees with the central plane, with the outer portion of the tip of the nostril locator 456 being farther back than the inner portion. The length of the nostril locator 456 is shortened by approximately 1 mm to approximately 11 mm. The exit aperture 492 defines a more rounded shape. For example, the dimension along the major 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 spaced slightly wider. For example, the spacing between the major axes 494 at the base and tip of the nostril locator 456 may be approximately 18.5 mm and approximately 11 mm, respectively.

[0158] 43, a further interface assembly 500 is shown arranged and configured in accordance with certain 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 secured to the frame 502 for use. In the illustrated configuration, the frame 502 provides attachment points for headgear or the like. The illustrated seal 504 incorporates a linking or attachment assembly 506 that can be joined to a flexible seal member 508. The seal member 508 comprises a proximal surface 530 (i.e., the surface closest to the user's face in use) and a distal surface 532 (i.e., the surface further from the user's face in 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 or similar to corresponding features of other interface assemblies disclosed herein, or may be of another suitable configuration.

[0159] The seal member 508 of FIG. 43 preferably includes features that facilitate or encourage flexing of the upper central portion of the seal member 508 that is aligned with the user's nose to inhibit or prevent excess pressure from being applied to the nose. In some configurations, the portions of the seal member 508 that define both the proximal and distal faces 530, 532 of the central portion flex forward to accommodate the user's nose. That is, in some configurations, the entire upper central portion of the seal member 508 may flex in a forward direction, rather than the proximal face 530 simply approaching the distal face 532, which is often substantially stationary, which may cause the proximal face 530 to stretch and thus cause discomfort. Flexing of the seal member 508 may not occur in all circumstances. For example, with certain face shapes, little or no flexing may occur, while with other face shapes, significant flexing may occur.

[0160] The illustrated seal member 508 includes a rib or protrusion 536 that connects to the connection or attachment assembly 506. A joint area 554 can connect the rib or protrusion 536 to the balance of the seal member 508. In some configurations, the thickness of the portion of the joint area 554 can be about 1.0 mm, and in some variations can be slightly larger or smaller, keeping in mind the need to reduce or eliminate the possibility of tearing during normal use. However, an upper central portion 560 of the seal member 508, which may include a portion of the joint area 554, preferably has a thinner wall thickness to facilitate or promote flexing (shown in dashed lines). The wall thickness of the upper central portion 560 can be the same as or similar to the peripheral region 458 of the seal member 428 of FIGS. 29-42, e.g., about 0.25 mm. In some configurations, the upper central portion 560 can be connected to or integral with the peripheral region 558 surrounding the nostril locators 556 of the seal member 508. In the illustrated configuration, the reduced wall thickness of the upper central portion 560 begins substantially just outside of the coupling or mounting assembly 536. Other suitable configurations that allow for flexural and / or rotational movement of the upper central portion 560 of the seal member 508 may also be used, such as the concepts and configurations disclosed in WO 2014 / 062070, the entire contents of which are incorporated herein by reference.

[0161] Unless the context clearly dictates otherwise, throughout the description and claims, the terms "comprises," "comprising," and the like, are to be construed in their inclusive sense, i.e., "including, but not limited to," as opposed to their exclusive or exhaustive sense.

[0162] The reference to any prior art in this specification is not, and should not be construed as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in the field of endeavor of any country in the world.

[0163] The present invention may also be generally described as consisting in the components, elements and features referred to or shown in the specification of this application, individually or collectively, and in any or all combinations of two or more of said components, elements or features.

[0164] In the above, where reference is made to components for which integers, or their equivalents, are known, those integers are incorporated herein as if individually set forth.

[0165] It should be noted that various changes and modifications of the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. For example, various components may be repositioned as necessary. Accordingly, such changes and modifications are intended to be included within the scope of the present invention. Moreover, not all of the features, aspects and advantages are necessarily required to implement the present invention. Accordingly, the scope of the present invention is intended to be defined solely by the following claims.

Claims

1. 1. A nasal seal configured for releasable connection to a frame of a patient interface, comprising: a seal body formed from a soft, flexible material and defining an internal cavity and one or more outlets for delivering breathing gas from the internal cavity to a patient; the seal body comprises a central portion and side portions extending from each end of the central portion, the seal body further comprising an inner side and an outer side, the inner side of the central portion configured to extend across the base of a user's nose and the inner side of each of the side portions configured to extend across a side of the nose, the inner side of the seal being flexible and configured to conform under internal pressure to a surface of the user's nose, including an outer surface of the side of the nose at the side portions of the seal, each of the side portions defining a transition portion between the outer side and the inner side, the outer side of each of the side portions comprising a reinforced region that is stiffer or much stiffer than the soft inner side, the reinforced region extending to or substantially to the transition portion. Nose seal.

2. The nasal seal of claim 1 , wherein the reinforced region is defined by a relatively thicker portion of the seal body.

3. The nasal seal of claim 2 , wherein the thickened portion tapers in thickness before the transition portion.

4. The nasal seal of claim 3 , wherein the transition portion includes a portion that is thicker than the flexible inner side.

5. A nasal seal according to any preceding claim, wherein the reinforced region extends along substantially the entire length of the exterior side of the seal body.

6. A nasal seal according to any preceding claim, wherein the transition portion comprises a rounded wall section.

7. A nasal seal according to any preceding claim, formed from a relatively rigid material and further comprising a support for supporting a portion of the seal body.

8. The nasal seal of claim 7 , wherein the support defines at least one grip surface portion extending along the exterior side of the seal body.

9. The nasal seal of claim 8 , wherein the at least one gripping surface portion comprises at least one pair of gripping surface portions substantially opposed to one another.

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

11. The nasal seal of claim 10, wherein the fitting comprises a first member connectable to a second member, the first member and the second member capturing a portion of the seal body therebetween.

12. The nasal seal of claim 11 , wherein the first member comprises a sleeve portion positioned within and extending outwardly from a cavity in the seal body.

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

14. A nasal seal according to any preceding claim, wherein the reinforced areas are located in the rearmost and lowest sections of the side portions.

15. The nasal seal of claim 14, wherein the rearmost and lowest sections of the side portions flare outwardly relative to adjacent portions of the seal body.

16. 16. A nasal seal according to any one of claims 1 to 15, wherein the one or more outlets comprise a first outlet and a second outlet, further comprising a nostril locator associated with and forming a portion of each outlet, and wherein a flexure region is defined within an annular transition between each nostril locator and a peripheral portion of the interior side, the flexure region having a lower stiffness than another region of the annular transition that is not within the flexure region.

17. 17. The nasal seal of claim 16, wherein the lower stiffness is achieved by the flexure area being thinner than the other areas of the annular transition portion.

18. 18. The nasal seal of claim 16 or 17, wherein the flexure area is located on an outer side of the nostril locator.

19. A nasal seal according to any one of claims 16 to 18, wherein the flexure area is limited to no more than half of the annular transition portion.

20. 20. A nasal seal according to any one of claims 1 to 19, wherein the central portion of the seal body defines a reduced thickness region that allows forward movement of an upper portion of the inner side of the central portion as a result of rotational movement of the seal body.

Images