Nasal seal for respiratory patient interface

Abstract

The invention relates to a nasal seal for a breathing patient interface. A nasal seal for a respiratory therapy mask for contacting a face of a user. The nasal seal has a body defining a cavity and a fluid inlet, and has two nasal prongs projecting from the body for delivering fluid to the nostrils of a user. A transition fillet is disposed between the nose prong and the body around the base of each prong, wherein each transition fillet has a constant chord length.

Description

[0001] This application is a divisional application of the Chinese patent application (international application number PCT / IB2019 / 057677) with application number 201980059869.4, application date September 12, 2019, and invention name “Nasal seal for respiratory patient interface”. Technical Field

[0002] The present disclosure relates generally to a respiratory patient interface and, in particular, to a nasal pillows mask. Background Art

[0003] Respiratory masks are used to provide respiratory therapy to the airways of people suffering from a variety of respiratory diseases or conditions. Such therapy may include, but is not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0004] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which a person's airway intermittently collapses during sleep, preventing the person from breathing for a sustained period of time. The cessation of breathing, or apnea, causes the person to wake up. Repeated and frequent apnea can result in the person rarely getting a full and restorative night's sleep.

[0005] CPAP therapy involves delivering a supply of continuous positive air pressure to a patient's airway via a breathing mask. The continuous positive pressure is used to hold the airway in an open position so that the patient's breathing and sleep are not interrupted.

[0006] CPAP therapy requires the user to wear a breathing interface that seals against the user's face around the user's nose and / or mouth via a seal / cushion to deliver breathing gases or a gas such as air to the user under positive pressure. Respiratory masks are available in a range of styles including full face masks, nasal masks, direct nasal masks, and mouth masks. The seal / cushion is held in place on the user's face by a headband that provides support for the breathing interface so that it remains in a stable position relative to the user's face during use. Such respiratory masks can also be used to provide NIV and other therapies.

[0007] If patients find the breathing interface uncomfortable or invasive, or if they find the appearance of the interface unattractive, they may be deterred from using CPAP therapy. A more discrete, compact user interface is needed. During treatment of OSA, patients wear the mask while sleeping, so the mask must have sufficient stability to not shift when the patient turns over in sleep.

[0008] CPAP therapy is often used in a home environment and sometimes requires changing the seal of the breathing interface for replacement or cleaning. For users with impaired motor function, replacing the seal or refitting the seal if it is separated from the support frame may be difficult. This often requires precise handling and may involve non-intuitive assembly steps and / or the use of separate connector parts.

[0009] Handling the seal in this manner, or indeed everyday handling, may cause portions of the seal to become inverted or flipped over on themselves, e.g., the nose prongs in a nose seal may curl inward or "pop out." This same tipping over of components may occur during use of the mask, e.g., due to improper assembly of the mask or due to movement of the mask. Righting these inverted components may be challenging for some users, particularly for those with impaired motor skills or vision.

[0010] In this specification, where reference is made to a patent specification, other external document or other source of information, this generally provides a context for discussing the features of the invention. Unless otherwise stated, reference to such external document or source of information should not be construed as an admission that such document or such source of information is prior art or forms part of the common general knowledge in the art in any jurisdiction. Summary of the invention

[0011] In a first aspect, the present disclosure is directed to a nasal seal for a respiratory therapy mask that contacts a user's face. The nasal seal has a body defining at least a portion of a cavity and a fluid inlet, two nasal prongs that protrude from the body for delivering fluid to the user's nostrils, and a transition fillet around the base of each prong between the nasal prongs and the body. The cavity forms a breathing chamber. Each transition fillet has a constant chord length.

[0012] In one embodiment, the nasal seal comprises an elastic material. For example, the nasal seal may comprise an elastomer, such as silicone. In one embodiment, the nasal seal comprises a single durometer silicone.

[0013] In one embodiment, the terminal region of each nose prong has a wall thickness that tapers toward the tip of the nose prong.The wall thickness at the tip of the nose prong may be less than 20% of the wall thickness of the nose prong wall in the majority of the nose prong.

[0014] In one embodiment, the nose prong wall thickness tapers over a length of about 2 mm. That is, the length of the end region of the prong is 2 mm. In alternative embodiments, the end region may be longer or slightly shorter, preferably in the range of about 1.2 mm to about 4 mm, more preferably in the range of about 1.6 mm to about 3 mm, and most preferably in the range of about 1.8 mm to about 2.5 mm.

[0015] The taper in the end region may be a non-linear taper. That is, the inner or outer surface of the taper has a curved surface so that the gradient of the taper changes along the length of the taper. In one embodiment, the taper has a varying chord length and a varying radius of curvature.

[0016] The taper may be an external taper. That is, the profile that reduces the wall thickness is located on the outer surface of the prong. In one embodiment, the outer surface of the prong is a curved surface at least in the end region when viewed in a cross section through the prong wall, and the inner surface of the prong is substantially linear at least in the end region.

[0017] Each nose prong defines a prong cavity, wherein the cross-sectional area of ​​each prong cavity decreases from a maximum area at the prong base to a minimum area at the prong tip. That is, the widest portion of the prong cavity is at the base of the cavity. The cross-sectional area of ​​each prong cavity can decrease from the base to the tip in a non-uniform and / or eccentric manner. For example, the nose prongs are made to conform to the anatomical structure of the user's nostrils and align with it. In one example, the prongs are angled upward toward each other.

[0018] In one embodiment, each nose prong defines a non-cylindrical cavity. For example, as described above, the cross-sectional area of ​​the prong cavity can decrease from the base to the tip in a non-uniform and / or eccentric manner. Alternatively or additionally, the cross-section of the nose prong can be non-circular. For example, the nose prong cavity can be rectangular, oval, or elliptical in cross-section, or can be another irregular curved shape. The cross-sectional shape of each nose prong cavity changes from the base of the prong to the tip of the prong. For example, the prong cavity can transition from an elliptical shape to a circular shape.

[0019] In one embodiment, each nose prong cavity has a cross-sectional shape having a major dimension along a major axis and a minor dimension along a minor axis, wherein both the major dimension and the minor dimension decrease from the base to the tip of the corresponding nose prong. For example, the shape may be one or more of an oval, a rectangular, or an elliptical shape.

[0020] In one embodiment, each nose prong includes a nostril sealing region located between the terminal region and the base of the corresponding prong. The nostril sealing region has a transition region adjacent to the terminal region of the prong. The transition region is concave. The transition region may have a constant chord length around the perimeter of the prong. In one embodiment, the outer surface of the nostril sealing region is convex.

[0021] In one embodiment, the nasal seal includes a rear user contact surface on the seal body, at least a portion of which is contoured to form a secondary seal with the user's face during use. For example, the seal body may form a secondary seal under the user's nose. In one embodiment, the rear user contact surface of the seal body has a thickness of about 170 mm. 2 and about 680mm 2 Between, preferably about 450mm 2 and about 650mm 2 between 500 mm and 1500 mm, more preferably between 520 mm and 1500 mm 2 and 570mm 2 In one embodiment, the surface area of ​​the user-contacting rear surface of the seal body is between about 28% and 110%, preferably between about 75% and about 105%, and more preferably about 90%, of the outer surface area of ​​each prong. In one embodiment, the outer surface area of ​​each prong is about 600 mm 2 However, in alternative embodiments, the outer surface area of ​​each fork may be 500 mm 2 To about 700mm 2 within the range.

[0022] In one embodiment, each nasal prong includes a nostril sealing region located between the distal region and the base of the respective prong, the wall thickness of at least a portion of the nostril sealing region being at least twice the wall thickness of the user contacting rear portion of the seal body. In one embodiment, the user contacting rear surface of the seal body has a wall thickness in the range of about 4 mm to about 0.6 mm, preferably about 0.45 mm. The nostril sealing region of the prongs preferably has a substantially uniform thickness of 0.76 mm to 0.85 mm, preferably 0.78 mm to 0.82 mm, preferably about 0.8 mm.

[0023] In one embodiment, the nasal seal body includes sidewalls extending between the inlet side of the seal and the rear user contact surface. The sidewalls may be about four to five times thicker than the wall thickness of the rear user contact portion of the seal body. In one embodiment, the sidewalls have a thickness of about 2 mm.

[0024] In one embodiment, the rate of change of the wall thickness of the nasal seal over the width of the transition fillet between the base and the body of each nasal prong is substantially constant around the periphery of the base. The inner surface of the nasal seal includes a corresponding chord circle located at the base of each nasal prong. The chord on each chord circle is substantially the same as the chord on the transition fillet. In one embodiment, the chord length ranges from about 3 mm to about 5 mm, for example about 4 mm. In some embodiments, the radius of curvature of the fillet and optionally the radius of curvature of the corresponding chord circle varies along the fillet / circle around the periphery of the prong. The radius can vary up to four or five times, or more. In one embodiment, the curvature of the fillet varies from about 2 mm to about 9 mm. In one embodiment, the radius of curvature of the transition fillet is largest at or near the bottom portion of the fillet and the corresponding prong.

[0025] In one embodiment, the fluid inlet is a substantially D-shaped opening, widest at the bottom of the opening and narrowest at the top of the opening. The opening can be shaped so that at least a majority of the opening of the nose fork cavity at the fork tip is directly aligned with the inlet. The width of the bottom of the opening can be about 1.5 times to about 2 times the width of the top of the opening. In one embodiment, the width of the bottom of the opening is about 1.8 times the width of the top of the opening.

[0026] In one embodiment, the nasal seal includes an inwardly extending lip at the fluid inlet for engaging the support frame. The lip can be D-shaped to define a D-shaped inlet. The lip can include an area of ​​increased wall thickness compared to the sidewalls of the nasal seal. In one embodiment, the lip has a depth of approximately 3 mm.

[0027] In one embodiment, the side profile of the lip (and the inlet defined thereby) is arcuate and concave relative to the front of the seal. In one embodiment, the lip side profile has a radius of about 25 mm and a center of curvature located in front of the nasal seal.

[0028] In one embodiment, the tips of the nasal prongs protrude rearwardly beyond the rear surface of the nasal seal body. In one embodiment, the tips of the nasal prongs protrude rearwardly beyond the sides of the nasal seal defined by the side portions of the body. In at least some embodiments, the nasal seal body does not contact the cheeks and / or bridge of the nose of the user, or does not extend over the nose of the user.

[0029] In one embodiment, each nose tines includes a web extending across the tines cavity. Each web may have a lower edge proximate the base of the corresponding tines and an upper edge spaced from the tip of the tines. In one embodiment, the cavity in each nose tines has a cross-section with a major axis and a minor axis, and each web extends generally along the minor axis, or generally parallel to the minor axis.

[0030] In a second aspect, the present disclosure relates to a nasal seal for a respiratory therapy mask that contacts a user's face. The nasal seal includes a body and at least one nasal prong. The body includes at least one sidewall and a fluid inlet, and the body defines at least a portion of a cavity. The nasal prong is configured to deliver fluid to a user's nostrils, the nasal prong includes a base adjacent to the mask body, a tip defining a prong outlet, and a prong wall extending between the base and the tip. The nasal prong defines a prong cavity and also includes a web extending across the prong cavity.

[0031] The web may be configured to reduce the likelihood of the fork tipping or overturning.

[0032] In one embodiment, the web includes an upper edge and a lower edge proximate the base, wherein at least a portion of the upper edge is spaced apart from the tip of the prong.

[0033] In one embodiment, the upper edge includes a central portion spaced apart from the tip of the prong and side portions extending from the central portion to the prong wall. The side portions may form a curved transition from the central portion of the upper edge to the corresponding inner surface of the prong wall.

[0034] In one embodiment, the distance between the two side portions at or near the tip of the prong is greater than the distance between the two side portions at or near the center portion of the upper edge.

[0035] In one embodiment, the central portion of the upper edge comprises a length greater than about 2.3 mm and / or less than about 3.8 mm, preferably comprises a length between about 2.3 mm and about 3.8 mm, such as about 3.3 mm.

[0036] In one embodiment, the side portion of the upper edge includes a first side portion and a second side portion, wherein the first side portion is longer than the second side portion.

[0037] In one embodiment, the side portions of the upper edge include a first side portion and a second side portion including a length greater than about 3.8 mm and / or less than about 4.7 mm, preferably including a length between about 3.8 mm and about 4.7 mm.

[0038] In one embodiment, the side portion of the upper edge comprises a first side portion and a second side portion, wherein the second side portion comprises a length greater than about 3.3 mm and / or less than about 4.4 mm, preferably comprises a length between about 3.3 mm and about 4.4 mm.

[0039] In one embodiment, the web is integrally formed with the nasal mask such that the web is continuous with the tine wall.

[0040] In one embodiment, the yoke cavity has a cross-section with a major axis and a minor axis, and each web extends generally along the minor axis, or substantially parallel to the minor axis.

[0041] In one embodiment, the width of the web is greater than the linear distance between the opposing inner surfaces of the yoke walls of the yoke on the minor axis or plane. The web may have a curvature. The curvature may enable compression of the yoke in both the minor and major directions. For example, compression in the major direction may result in stretching and / or straightening of the web across its width; and / or compression in the major direction may result in flattening and / or tensioning of the web.

[0042] In one embodiment, compression in the secondary direction causes the web curvature to increase.

[0043] In one embodiment, the nose prong is a first nose prong, and the nose seal further comprises a second nose prong having any one or more of the features described above with respect to the first nose prong. Preferably, the second nose prong is substantially identical to the first nose prong, although the orientation of the nose prongs may vary, for example, the first nose prong and the second nose prong may be symmetrical.

[0044] In one embodiment, the nasal seal includes two nasal prongs, wherein the tips of the nasal prongs protrude rearwardly beyond the rear surface of the nasal seal body.

[0045] In a third aspect, the present disclosure relates to a nasal seal for a respiratory therapy mask, which is used to contact the user's face, the nasal seal comprising an elastic material and having a body defining a cavity and a fluid inlet and also comprising two nasal prongs protruding from the body, the nasal prongs being used to deliver fluid to the user's nostrils; wherein the terminal area of ​​each nasal prong has a wall thickness that tapers toward the tip of the nasal prong, wherein the wall thickness at the tip of the nasal prong is less than 20% of the thickness of the nasal prong wall in the main non-tapered portion of the nasal prong.

[0046] The nose seal may have one or more of the features described above with respect to the first aspect. For example, in the terminal region, the nose prong wall thickness may taper over a distance of about 2 mm, and / or the terminal region may have a taper with a varying chord length and a varying radius of curvature.

[0047] In a fourth aspect, the invention is directed to a frame for a nasal respiratory mask, the frame comprising an inlet and an outlet, having an upper outwardly projecting flange adjacent the outlet and a lower outwardly projecting flange adjacent the outlet, the upper outwardly projecting flange and the lower outwardly projecting flange being for positively engaging a nasal seal, wherein the length of the lower outwardly projecting flange is greater than the length of the upper outwardly projecting flange.

[0048] In one embodiment, the frame includes a seal retaining edge adjacent to the frame outlet. The seal retaining edge can be, for example, generally D-shaped to complement the D-shaped inlet of the complementary nasal seal. In one embodiment, the seal retaining edge includes an upper surface, a lower surface, and two opposing side surfaces extending between the upper surface and the lower surface. In one embodiment, the upper surface of the seal retaining edge is narrower than the lower surface of the seal retaining edge. For example, the width of the lower surface of the seal retaining edge can be about 1.5 times to about 2 times the width of the upper surface of the seal retaining edge. In one embodiment, the width of the lower surface of the seal retaining edge is about 1.8 times the width of the upper surface of the seal retaining edge.

[0049] The upper and lower flanges may protrude from the seal retaining rim to a depth substantially corresponding to the surface of the lip on the complementary nasal seal. In one embodiment, the flanges protrude approximately 1 mm from the respective surfaces of the seal retaining rim.

[0050] In one embodiment, the lower flange is wider than the upper flange.

[0051] In one embodiment, the lower flange is disposed along a rear edge of a lower surface of the seal retaining rim. In one embodiment, the upper flange is disposed along a rear edge of an upper surface of the seal retaining rim.

[0052] The upper flange may extend along at least a majority of the length of the upper surface of the seal retaining rim; the lower flange may extend along at least a majority of the length of the lower surface of the seal retaining rim. In one embodiment, the upper flange extends along substantially the entire length of the upper surface of the seal retaining rim. In one embodiment, the lower flange extends along substantially the entire length of the lower surface of the seal retaining rim.

[0053] That is, the upper flange may extend along at least most of the length of the upper edge of the inlet, and the lower flange may extend along at least most of the length of the lower edge of the inlet. In one embodiment, the upper flange extends along substantially the entire length of the upper edge of the inlet. In one embodiment, the lower flange extends along substantially the entire length of the lower edge of the inlet.

[0054] Corners of the seal retaining rim where the side surface adjoins the upper surface and the lower surface may be curved.Two corners on each of the upper flange and the lower flange may be curved.

[0055] In one embodiment, the outlet is substantially D-shaped.

[0056] In one embodiment, the depth of the seal retaining rim varies around the periphery of the rim. In one embodiment, the rim side surfaces have a depth of approximately 3 mm, and the upper and lower rim surfaces have a depth of approximately 3.5 mm.

[0057] In one embodiment, the distance between the upper flange and the inlet 15 is greater than the distance from the lower flange to the inlet 15 .

[0058] In one embodiment, a collar is provided at the inlet for coupling the fluid conduit to the frame.

[0059] The framework may include a series of bias holes adjacent to the inlet, which are arranged along an arc. In one embodiment, the framework includes two arc-shaped rows of bias holes arranged on opposite sides of the inlet. In one embodiment, each row includes 10 to 16 (inclusive) bias holes, more preferably 12 to 14 (inclusive) holes.

[0060] In one embodiment, the flow diversion holes are provided in the transition region between the collar at the inlet and the main body of the frame, such as through a radiused surface extending between the catheter connector at the outlet and the main body of the frame.

[0061] In one embodiment, the bias holes are angled to direct the airflow forward and outward. That is, the airflow from these holes does not impact any surface of the frame. In one embodiment, these bias holes are spaced apart, wherein the centers of adjacent bias holes are spaced apart by about 1.2 mm and / or the axes of adjacent holes form an angle of about 7 degrees.

[0062] In an alternative embodiment, the frame includes one or more diffusion holes disposed in the frame, the diffusion holes communicating with the fluid chamber. The diffusion holes may include generally triangular holes positioned to the left and right adjacent to the inlet, a single rectangular, elliptical or trapezoidal hole positioned in the upper region of the frame; or may include one or more holes of alternative shapes.

[0063] In one embodiment, the frame inlet forms an angle of approximately 30 degrees with the frame outlet.

[0064] In one embodiment, the diffusion hole includes a hole adjacent to the upper outwardly protruding flange, and the frame also includes a plurality of channels in fluid communication with the hole and extending away from the hole. The channels may include diverging grooves. The channels may be arranged to be positioned below the pull tab of the nasal seal.

[0065] A breathable diffuser pad is provided over the or each diffuser hole. The diffuser pad may be overmoulded with the frame.

[0066] In one embodiment, the frame is a two-part frame comprising a body and a diffusion clip engageable with the body, and wherein the diffusion clip comprises one or more diffusion holes arranged to communicate with the fluid chamber.

[0067] In one embodiment, the frame further comprises a coupling arm having a coupling feature configured to attach the frame to the headband, the coupling feature being arranged at an angle such that reaction forces from the headband will be substantially evenly distributed on the attached nasal seal to enhance the seal with the user. The coupling feature may comprise one or more of a hole, a clip, a post, a socket, or a detent to receive a complementary feature on the attachment headband.

[0068] In one embodiment, the coupling arms each include a convex rear surface. In one embodiment, the curvature of the convex rear surfaces corresponds to the curvature of the lip surrounding the inlet on the attached nasal seal. In one embodiment, the convex rear surfaces have a radius of approximately 25 mm and a center of curvature located in front of the nasal seal.

[0069] In one embodiment, the frame includes a pull tab alignment surface comprising a flat surface on an upper surface of the frame forward of the outlet to align with a pull tab on a complementary nasal seal.

[0070] In a fifth aspect, the present disclosure is directed to a frame assembly for a nasal respiratory mask. The frame assembly comprises a frame as described above with respect to the second and third aspects and a connector for coupling the frame to a conduit, wherein the connector comprises one or more diffusion holes.

[0071] In one embodiment, a series of holes are arranged in an annular shape on the connector. An annular air-permeable diffusion pad may be arranged above the diffusion holes.

[0072] In one embodiment, the frame comprises one or more air blocking sheets arranged to block air flow from the diffuser holes in the region of the air blocking sheets.

[0073] In one embodiment, the connector is overmolded with the catheter.

[0074] In a sixth aspect, the present disclosure is directed to a respiratory mask. The respiratory mask comprises a frame as described above with respect to the fourth aspect and a nasal seal as described above with respect to the first or second aspect. The frame is configured to be connected to a headgear, and the nasal seal is deformable or deformable around a portion of the frame and is biased into engagement with the frame.

[0075] In a seventh aspect, the present disclosure is directed to a respiratory mask comprising a frame as described above with respect to the fourth aspect, configured to be connected to a headband, and a nasal seal for contacting a user's face. The nasal seal comprises at least one nasal prong configured to deliver fluid to a user's nostril, the nasal prong comprising a base adjacent to the body, a tip defining a prong outlet, and a prong wall extending between the base and the tip, and the nasal prong defines a prong cavity. An upper outwardly projecting flange engages or can engage with a top portion of a nasal seal fluid inlet, and a lower outwardly projecting flange engages or can engage with a lower portion of the nasal seal fluid inlet, and the nasal seal engages or can engage with the frame by deforming the seal around a portion of the frame.

[0076] In one embodiment, the upper flange of the frame engages or can engage with the top of the nasal seal fluid inlet, and the lower flange of the frame engages or can engage with the lower portion of the nasal seal fluid inlet. For example, in one embodiment, the nasal seal has an inner lip adjacent to the nasal seal inlet, the upper flange of the frame engages or can engage with the top portion of the lip, and the lower flange of the frame engages or can engage with the lower portion of the lip. In one embodiment, when the seal engages the frame, side portions of the lip abut side portions of the seal retaining rim.

[0077] In one embodiment, the frame has a seal retaining rim adjacent to the frame outlet, and the seal inlet rests on the seal retaining rim. The fluid inlet on the nasal seal can be narrower and / or shorter than the seal retaining rim on the frame, thereby ensuring that the nasal seal is in tension when it is assembled to the frame.

[0078] In one embodiment, the nasal seal includes a pull tab adjacent the top of the nasal seal fluid inlet to facilitate engagement of the nasal seal with the frame and removal of the nasal seal from the frame.

[0079] In one embodiment, one or more diffusion holes communicating with the fluid chamber are provided in the frame, and the front edge of the diffusion hole is located in front of the front edge of the pull tab.

[0080] In one embodiment, the respiratory mask further comprises a connector for coupling the frame to the conduit. The connector comprises one or more diffusion holes. The diffusion holes may comprise a series of holes arranged annularly on the connector.

[0081] In one embodiment, the connector includes an annular air-permeable diffuser pad disposed over the diffuser hole.

[0082] In one embodiment, the frame comprises one or more air blocking sheets arranged to block air flow from the diffuser holes in the region of the air blocking sheets.

[0083] In one embodiment, the respiratory mask comprises a conduit, wherein an end of the conduit is overmolded to the connector.

[0084] The term "comprising" as used in this specification and claims means "consisting at least in part of..." When interpreting statements in this specification and claims including the term "comprising", other features may be present in addition to those features preceded by the term. Related terms such as "including" and "comprising" should be interpreted in a similar manner.

[0085] Reference to a numerical range disclosed herein (e.g., 1 to 10) also includes reference to all rational numbers within that range and any range of rational numbers within that range (e.g., 1 to 6, 1.5 to 5.5, and 3.1 to 10). Therefore, all subranges of all ranges explicitly disclosed herein are hereby explicitly disclosed.

[0086] As used herein, the term "(s)" following a noun refers to the plural and / or singular form of the noun. As used herein, the term "and / or" means "and" or "or", or, where the context permits, both.

[0087] As used herein, the term "about" means that a measurement or other quantity is intended to include the other measurement or quantity within a manufacturing or measurement tolerance that differs from a specified value. BRIEF DESCRIPTION OF THE DRAWINGS

[0088] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0089] Figure 1 is a schematic diagram showing a user wearing an exemplary respiratory user interface including a headgear, a frame, and a nasal seal, the interface being connected to a supply conduit;

[0090] Figure 2 yes Figure 1 a side view of a respiratory interface of with a supply conduit connected but with the headgear removed and showing the relative angles of the user interface components;

[0091] Figure 3 yes Figure 2 A front perspective view of an assembled breathing interface;

[0092] Figure 4yes Figure 2 and Figure 3 A front perspective view of the mask with the supply conduit removed;

[0093] Figure 5 is corresponding to Figure 4 Wire frame front elevation view of

[0094] Figure 6 is an exploded front perspective view showing the nose seal separated from the frame;

[0095] Figure 7 yes Figures 1 to 6 A top front perspective view of a nose seal;

[0096] Figure 8 yes Figure 7 A wire frame front view of a nose seal;

[0097] Fig. 9 yes Figure 7 and Figure 8 A wire frame rear view of a nose seal;

[0098] Fig.10 yes Figures 7 to 9 A side view of a nasal seal schematically illustrating the geometry of the leading edge of the seal and the fluid inlet;

[0099] Fig.11 yes Figures 7 to 10 a perspective cross-sectional view of a nasal seal of , taken in a vertical plane through the body of the seal, showing an interior view of a fluid inlet and an attachment lip;

[0100] Fig.12 yes Figures 7 to 10 a three-dimensional detail view of one of the nose prongs of the nose seal;

[0101] Fig.13 yes Figures 7 to 10 a wire frame rear detail view of one of the nose prongs of the nose seal;

[0102] Fig.14 is a detailed cross-sectional view of a portion of one of the nose prongs showing the taper of the wall thickness at the tip of the nose prong;

[0103] Fig.15 is used for Figure 1 A front perspective view of an exemplary embodiment of a nasal seal support frame of a respiratory interface;

[0104] Fig.16 yes Fig.15 A rear perspective view of a nasal seal support frame;

[0105] Fig.17 yes Fig.15 and Fig.16 A front view of a nasal seal support frame;

[0106] Fig.18 yes Figures 15 to 17 a rear view of a nose seal support frame;

[0107] Fig.19 yes Figures 15 to 18 a top elevation view of a nasal seal support frame;

[0108] Fig. 20 yes Figures 15 to 19 an underside elevational view of a nasal seal support frame;

[0109] Fig.21 yes Figures 15 to 20 A side view of a nasal seal support frame;

[0110] Fig.22A and Fig. 22B yes Figures 15 to 21 A side cross-sectional view of a nasal seal support frame showing dimensions of the frame;

[0111] Fig.23A and Fig. 23B It shows Figure 25 to Figure 21 A view of the angular dimensions of the nasal seal support frame, wherein Fig.23A is a partial front view, and Fig. 23B is a side cross-sectional view;

[0112] Fig.24 is a detailed view showing a flow diversion hole in a nasal seal support frame adjacent a fluid inlet;

[0113] Fig.25 is a side view showing an assembly of a frame and a nasal seal and illustrating connection forces;

[0114] Fig.26 is a side cross-sectional view showing engagement of a nasal seal with a frame;

[0115] Fig. 27 is a front cross-sectional view taken through a plane through the attachment lip of the nasal seal, illustrating the attachment between the seal and the frame;

[0116] Fig.28 is a top cross-sectional view showing engagement of the nasal seal with the frame;

[0117] Fig.29 is a side cutaway perspective view showing variations in wall thickness of a nasal seal;

[0118] Fig.30is a side cross-sectional view showing a nasal seal;

[0119] Fig.31 is a rear view of the nose seal showing contrasting surface areas of the nose prongs and the secondary sealing surface;

[0120] Fig.32 is a rear perspective view of a second embodiment of a nasal seal having a web in the nasal prongs;

[0121] Fig.33A yes Fig.32 A side view of a nose seal;

[0122] Fig.33B It passes through Fig.33A The line 33b is intercepted Fig.32 A cross-sectional view of a nose seal;

[0123] Fig.34A yes Fig.32 A side view of a nose seal;

[0124] Fig.34B It passes through Fig.34A The line 34b is intercepted Fig.32 A cross-sectional view of a nose seal;

[0125] Fig.35 yes Figures 32 to 34B a cross-sectional view of a nose seal of the embodiment of the present invention, the cross-section being taken through a plane adjacent to and parallel to the web of the nose prong;

[0126] Fig.36A yes Figure 32 to Figure 35 a cross-sectional view of a nose seal, the cross-section being taken through and perpendicular to a plane of the nose prong web;

[0127] Fig.36B is a front perspective view of another embodiment nose seal having an alternative nose prong web, wherein the web is shaped for ease of manufacture;

[0128] Fig.36C yes Fig.36B a rear view of a nose seal;

[0129] Fig.36D is taken through a plane adjacent to and substantially parallel to the web of the nose prong Fig.36B and Fig.36C A cross-sectional view of a nose seal;

[0130] Fig.36E It passes through Fig.36D A detailed view of a cross section of the nose fork;

[0131] Fig.36FIt is used to manufacture FIG. 36B to FIG. 36E A three-dimensional view of a mold core of a nose seal;

[0132] Figure 36G yes Fig.36F A three-dimensional diagram of a mold core;

[0133] Fig.36H It passes through Fig.36F The plane AA in the middle is used to make FIG. 36B to FIG. 36E A cross-sectional view of an assembly tool for a nose seal;

[0134] Fig.36I It passes through Fig.36F The plane BB in the middle is used to make FIG. 36B to FIG. 36E A cross-sectional view of an assembly tool for a nose seal;

[0135] Fig.37 is a front view of a second embodiment nasal seal support frame having a triangular front diffuser hole;

[0136] Fig.38A It is shown that Fig.37 The supporting frame and Figures 32 to 36A A front perspective view of a breathing interface of a nasal seal;

[0137] Fig.38B yes Fig.38A A front lower side stereogram of a breathing interface;

[0138] Fig.39 is a front view of a third embodiment of a nasal seal support frame having an upper front diffuser hole;

[0139] Fig.40 yes Fig.39 A side view of a supporting frame;

[0140] Fig.41A is a front perspective view of a nasal seal support frame of a fourth embodiment having an upper diffuser hole and a diffuser channel;

[0141] Fig.41B yes Fig.41A a detailed front perspective view of a portion of a frame with a nasal seal attached to the frame;

[0142] Fig.42 yes Fig.41A and Fig.41B A front perspective view of a support frame;

[0143] Fig.43A is an exploded side view of a fifth embodiment respiratory interface assembly having a nasal seal, frame, diffuser pad, connector, and conduit;

[0144] Fig.43B yes Fig.43A Front stereogram of

[0145] Fig.44 yes Fig.43A and Fig.43B A front perspective view of a support frame;

[0146] Fig.45A is a side view of a sixth embodiment of a nasal seal support frame;

[0147] Fig.45B yes Fig.45A An exploded side view of a frame;

[0148] Fig.46A yes Fig.45A A rear view of the supporting frame;

[0149] Fig.46B yes FIG. 45A to FIG. 46A A rear view of the diffusion clamp of the support frame;

[0150] Fig.47 is a front perspective view of a nasal seal support frame of a seventh embodiment;

[0151] Fig.48 is a cutaway detailed cross-sectional view showing the connection between the diffusion clip and the support frame body;

[0152] Fig.49 is a front perspective view of an eighth embodiment nasal seal support frame with an attached catheter connector;

[0153] Fig.50A yes Fig.49 A front perspective view of a nasal seal support frame;

[0154] Fig.50B yes Fig.49 A front perspective view of a catheter connector;

[0155] Fig.51 yes Fig.49 A side view of a nasal support frame and attached catheter connector;

[0156] Fig.52 yes Figures 49 to 51 An exploded side view of a nasal support frame and attached catheter connector;

[0157] Fig.53 is a front view of a nasal seal support frame of an eighth embodiment;

[0158] Fig.54 yes Fig.53 a front view of a nasal seal support frame and an attached nasal seal;

[0159] Fig.55 It is taken through the center line of the frame Fig.54 A side cross-sectional view of a nose seal support frame and seal;

[0160] Fig.56 yes Fig.54 and Fig.55 A side view of a nasal seal support frame and seal;

[0161] Fig.57 yes Fig.53 A side cross-sectional view of a nasal seal support frame;

[0162] Fig.58 is a side cross-sectional view of a felt fiber mat for forming into a diffuser mat;

[0163] Fig.59 yes Fig.58 a partial side cross-sectional view of a pad formed as a diffuser pad and overmolded with a nasal seal support frame;

[0164] Fig.60 It is shown that the formation Fig.59 A partial side cross-sectional view of a mold tool for a method of overmolding a diffuser pad and a frame;

[0165] Fig.61 is shown overmolded to Figure 53 to Figure 57 A stereoscopic view of the diffuser pad of the nasal support frame. DETAILED DESCRIPTION

[0166] Now refer to Figures 1 to 31 Various embodiments and methods of manufacture are described. In these drawings, like reference numerals are used to indicate like features.

[0167] Directional terms used in the following description are for ease of description and reference only and are not intended to be limiting. For example, the terms "front," "rear," "upper," "lower," and other related terms refer to the position of a component or portion of a respiratory mask relative to a user when the user is wearing the respiratory mask. In this specification, "rear" refers to a position closer to the user (when the mask is in use), while "front" refers to a position farther from the user in comparison. The terms "upper" and "lower" refer to the position of a portion or component of the mask relative to the rest of the mask when the mask is in use and the user is sitting in an upright position. Arrows F are included where appropriate in the figures to indicate the forward direction of the device.

[0168] Figure 1An exemplary embodiment of a nasal respiratory interface 1 is shown. The respiratory interface comprises: a frame 3, wherein a headband 7 is attached to a connector 13 on the frame; and a nasal seal 5 for sealing with the user's face to supply breathing gas to the user at the nose. The nasal seal 5 is removably mounted to the frame 3. A fluid supply conduit 9 is coupled to a fluid inlet 15 on the frame for supplying breathing gas to the user.

[0169] Figures 7 to 14 A nasal seal component 5 is shown. The nasal seal 5 includes a body 10 and two nasal prongs 11 that protrude from the body 10 for delivering fluid into the nares of a user. The body 10 defines a main cavity 19 and a fluid inlet 17 that allows fluid to enter the cavity 19. The nasal seal 5 includes a resilient material, such as silicone, so that the nasal seal 5 has a self-supporting shape but is able to deflect to conform to the contours of the user's face.

[0170] In use, the nasal prong 11 is at least partially positioned in or at the base of the user's nostril to direct fluid into the nasal passage. The nasal prong 11 has a nostril sealing area to contact the inner surface of the nostril and create at least a partial seal with the nostril.

[0171] The rearward surface A2 ( Fig.31 ) contacts the user's face to form a secondary seal with the face. The rear surface may contact the user's face at one or more of the areas below the nose, beside the nose, or above the tip of the nose. This contact between the user's face and the body 10 creates a secondary seal that serves as a backup seal to compensate for seal leaks that may occur between the nostrils and the nasal prongs 11. This contact also provides support to stabilize the mask on the user's face. The nasal seal body 10 can be contoured to fit closely to the user's face and can be obtained in different sizes or geometries to accommodate different users.

[0172] Reference Fig.31 , the user contact rear surface A2 of the seal body 10 has a diameter of about 544 mm 2 The surface area of ​​the rearward surface A2 (eg, Fig.31 The secondary seal may be formed by the surface being located between the prongs, the area between the tangent lines 41, 43 at the top and bottom of the prongs being approximately 170 mm 2 In contrast, the surface area of ​​each fork is about 600mm 2 It will be appreciated that these areas will vary between embodiments for masks of different sizes.

[0173] An excellent secondary seal is typically provided by a nasal seal having a large body with thin walls, because the seal has a large contact surface area to seal around the nose, and the thin walls enable the seal to fit closely to the face by expanding ("ballooning") into the user's face under pressure. However, the large size of these larger seals, which typically rest against the cheek and are as high as the bridge of the user's nose, can be a barrier to treatment compliance due to their intimidating and obtrusive appearance.

[0174] In the presently described nasal seal 5, the body 10 is compact to provide a less obtrusive option. The body 10 in the nasal seal 5 is primarily used to connect two nasal prongs 11. For example, in the illustrated embodiment, the exemplary nasal seal 5 is approximately 50 mm at its widest point, and the seal 5 is approximately 30 mm at its maximum vertical dimension. In the illustrated embodiment, this represents a reduction of approximately 25% in width and height of the seal compared to existing masks of comparable fit size. However, it is clear that these dimensions will vary with different sized seals to fit different user groups.

[0175] like Figure 2 and Fig.10 As shown, due to the compact body, no portion of the nasal seal body 10 extends behind the tip 11a of the nasal prongs 11. That is, no portion of the body of the nasal seal 10 protrudes behind the prong tip 11a for sealing with the cheeks or the bridge of the nose.

[0176] Reference Fig. 9 At the rear surface of the seal 5, the top 10a of the nose seal body 10 is narrower than the bottom 10b of the seal. The perimeter of the seal 5 is closely related to the size and orientation of the base of the two prongs 11 so as to accommodate the base of the two prongs 11. Fig. 9 As can be seen in FIG. 1 , the long axis of the nose fork cavity is larger at the bottom of the fork 11 than at the tip 11a (S t ) is further apart from S b .

[0177] The patient-facing / contacting rear surface 10c of the nasal seal 5 is concave to complement the convex surface of the user's face so that the bottom portion 10b of the body 10 contacts the user's face under the user's nose to form a primary secondary sealing surface for preventing or reducing leakage under the nose. As described above, this compact configuration has a more discrete appearance and is less obtrusive, as is often desired by CPAP home users.

[0178] However, as discussed above, this more compact size provides a reduced contact surface with the user's face compared to larger seals. The reduced height and width of the presently described nasal seals means that the seal 5 sits lower on the wearer's nose and in some cases may not cover the tip of the wearer's nose and does not extend very far over the cheeks. Therefore, the compact mask of the present invention cannot rely on a large surface contact area to provide stability on the user's face during mask use. Mask stability is important in CPAP, particularly where treatment is provided throughout the night - it is important that small movements of the user during sleep do not cause the mask to move out of sealing contact with the nares, particularly up / down movements of the mask.

[0179] To compensate for the reduced user contact surface area 10c, the sidewalls 18 have a thickness sufficient to maintain the spacing between the frame 3 of the mask and the rear user contact rear surface 10c of the nasal seal, particularly under the force applied by the headband during use. In the embodiment shown, the sidewalls 18 of the nasal mask 5 have a wall thickness of approximately 2 mm. This may be uniform in the side regions, or may taper gradually towards thinner top and bottom regions, for example.

[0180] In addition, the (user contact) rear wall 10c of the body 10 has a certain wall thickness, which is selected to ensure that the seal does not collapse / flatten under the pressure from the nostrils of the headband 7 when in use, and the wall thickness provides stability for the mask to fully support the prongs 11. In the embodiment shown, the (user contact) rear wall of the body 10 has a wall thickness of approximately 0.45mm. In other words, the rear wall thickness is less than 25% of the thickness of the side wall 18 of the nose seal. However, it is envisioned that in alternative embodiments, this can be slightly thicker or thinner, for example in the range of 0.25mm to about 0.55mm. The wall thickness of the nose seal gradually decreases from the side wall 18 to the (user contact) rear wall 10c.

[0181] Specific reference Fig. 9 and Fig.13 Each nose prong 11 has a non-circular cross section that narrows non-linearly from the base 11b of the nose prong to the tip 11a of the nose prong ( Fig.12), thereby defining a non-cylindrical cavity. The tip 11a of the nose prong defines a prong outlet. In the illustrated embodiment, the nose prong has an elliptical cross-section having a major dimension and a minor dimension that are larger at the base 11b of the nose prong than at the tip 11a of the nose prong. The non-circular cross-section enables the nose prong to fit more closely to the inner wall of the nostril for comfort, and thereby achieves a better seal with the nasal passage. In addition, the narrowing of the nose prong cavity helps to reduce the possibility of the nose prong tipping over during use, because the internal pressure from the breathing gas helps to bias the nose prong outward. The nose prong cavity 12 can be eccentric, that is, the opening at the tip 11a of the prong is not centered on the opening at the base 11b of the prong, and / or the nose prongs can be angled toward each other, for example, because each nose prong extends vertically from a concave surface and is angled toward each other.

[0182] The non-circular shape of the nose prong 11 means that, at a given distance along the prong 11, the radius of curvature of the nose prong outer surface varies around the perimeter of the nose prong, including at the base 11b of the nose prong. In addition, the major and minor dimensions of the nose prong cavity 12 do not have to vary by the same amount from the base 11b of the nose prong to the tip 11a of the nose prong, e.g., the nose prong cavity can be eccentric. Thus, the nose prong wall steepness relative to the seal body 10 can also vary around the perimeter of the nose prong.

[0183] In this example, at the base 11b of the nose prong, the surface transition from the nose seal body 10 to the prong is sharper (has a greater angle change) at the side of the nose prong (i.e., in line with the minor axis of the cavity 12) than at the bottom of the nose prong base 11b (where the surface transition is more gradual).

[0184] In a nasal mask having a radial fillet between the fork surface and the main body surface, the width (chord) of the radial fillet depends on the angle between the two surfaces; where the angle between the two surfaces is more acute, the fillet will be wider, and where the angle change is small, the fillet will be narrower. Thus, for example, in the present embodiment, the change in wall steepness around the periphery of the nasal fork 11 is combined with the radial fillet to result in a fillet with a narrower width at the bottom of the fork where the angle change from the secondary seal surface to the fork is small. Because the transition between the wall thickness of the secondary seal and the wall thickness of the fork 11 occurs across the width of the fillet, a narrower fillet means a more abrupt change in thickness. The abrupt change in thickness results in a weakened or turning area with reduced stiffness, where the fork is more susceptible to deflection than other areas. While some deflection allows the cushion to adapt to different nose structures, too much deflection may cause the nasal fork to collapse or tip over.

[0185] For example, in this embodiment, at the bottom of the nose prong base 11b, where the angle between the prong wall surface and the body 10 is most obtuse, the radial rounding will create a weaker area where the nose prongs are prone to folding or kinking, such as due to movement of the mask. This makes the nose prong 11 more dependent on internal pressure from the breathing gas to prevent the nose prongs from tipping over during use.

[0186] In contrast, in the illustrated embodiment of the nose seal, a transition fillet 27 is provided between the nose prong 11 and the body 10 at the base 11b of each nose prong. The transition fillet 27 surrounds the base of the prong 11 at the periphery of the prong to form a smooth transition between the outer surface of the prong 11 and the rear surface of the body 10 of the nose seal 5. The transition fillet 27 has a constant chord length. That is, the two edges defining the transition fillet 27 are parallel, so that the "width" of the transition fillet 27 is constant. Due to the changing angles and curvatures of the walls of the nose prong 11, the radius of curvature of the transition fillet varies around the periphery of each prong.

[0187] The thickness of the seal wall gradually transitions from matching the thickness of the body rear wall (0.45 mm in this example) to the thickness of the nose yoke wall (about 0.8 mm in this example) in the area of ​​the transition fillet 27. Since the fillet has a constant width, the transition between the wall thickness of the body rear wall and the yoke wall is constant around the perimeter of the yoke base, so there is no weak area due to a sudden change in wall thickness. In particular, this provides a stiffer transition at the base of the yoke than using a radial fillet.

[0188] On the inner surface of the nose seal 10, a corresponding chord circle is formed at the base of the prong 11 (see Fig.28 It is contemplated that these thicknesses may vary between embodiments, but preferably the nasal prong thickness is less than about 2.5 times the thickness of the adjoining rear wall of the nasal seal body 10, and more preferably less than 2 times.

[0189] The transition fillet 27 of constant chord length provides a flexure area with substantially uniform stiffness along the fillet for each fork 11, thereby advantageously avoiding the creation of an area that is more prone to excessive turning or folding. The chord fillet also gives the fork wall surface a smoother appearance, which is more aesthetically pleasing. The chord length of the chord circle can be selected to be as large as possible within the size constraints of the nose seal body 10, the distance between the nose fork and the depth of the nose fork. In the illustrated embodiment, the transition fillet has a chord length of about 4 mm. The radius of curvature of the fillet varies from about 2 mm to about 9 mm along the fillet. However, the chord length can vary between embodiments depending on the size of the seal and the fork geometry.

[0190] Due to the compact nature of the secondary seal, the forces from the headband and from the fluid flow entering the mask are mostly transmitted to the user's face via the prongs, with a smaller portion of the forces being dispersed via the secondary seal surface than a mask with a larger secondary seal surface. The more gradual thin-to-thick transition between each prong 11 and the body 10 advantageously creates a more rigid connection between the prong 11 and the body 10 to accommodate these forces. This can reduce the occurrence of collapse or "bottoming out" of the prongs during assembly, and in addition, if the prongs become overturned or collapsed, it will cause the prongs to "pop out" more easily when they are restored.

[0191] The wall thickness of each nose prong 11 is substantially constant along most of the length of the prong. In the present example, the prongs are silicone and have a substantially uniform main wall thickness of about 0.8 mm and a length of about 9.5 mm. However, it is contemplated that the wall thickness may vary depending on the material properties and the size of the nose prong. The wall thickness may be selected to make the nose prong self-supporting and to provide the nose prong with resistance to tipping over or collapse, particularly during assembly of the mask 1.

[0192] Each prong 11 has a terminal region 14 at the tip of the prong and a nasal sealing region 18 extending from the base 11b of the prong 11 to the terminal region 14. The terminal region 14 of each nasal prong 11 has a wall thickness that tapers toward the tip 11a of the nasal prong. This taper provides a softer, more compliant tip of the nasal prong 11b for comfort and improved sealing. The taper is provided by an external taper. The thinned region reduces the pressure load on the soft nasal tissue during use to reduce the possibility of pressure sores.

[0193] In this example, the wall thickness of the nose prong 11 tapers from a thickness t1 of about 0.8 mm to a thickness t3 of about 0.1 mm at the tip over the length of the terminal region 14. In alternative embodiments, the degree of taper may vary, but preferably, the wall thickness at the tip 11a of the nose prong is less than about 20% of the wall thickness of the non-tapered lower nostril sealing region 18.

[0194] In the terminal region 14, the nose prong wall thickness is about 2 mm over a distance d t The taper / end region 14 tapers gradually upward, however, in alternative embodiments, the taper / end region 14 may be longer or slightly shorter. In the illustrated embodiment, the taper 14 is non-linear, thereby forming a convex outer surface having a decreasing radius of curvature toward the tip 11a of the nose prong and having a varying chord length. For example, at the midpoint along the taper (1 mm d m ), in this example, the wall thickness t2 is about 0.65 mm.

[0195] For example, the outer surface in the terminal region may be contoured to fit the shape of a user's nostrils.

[0196] This contour is such that the transition from the nostril sealing region 18 to the distal region 14 is gradual without an abrupt turn. Fig.14 At the base of the terminal region 14, the surface curvature of the nose prong 11 is such that it is tangential to the adjacent nostril sealing region 18 so as to create a smooth transition.

[0197] Between the base 11b and the terminal region 14 of the prong, the profile of the nostril sealing region 18 of the prong is designed to provide a smooth transition between the terminal portion 14 and the base 11b of the prong 11. Most of the nostril sealing region 18 includes a convex outer surface to seal against the bottom of the user's nostril. The convex surface bulges outward in response to the axial load of the prong, thereby providing a cushioning effect. At the top of the nostril sealing region 18, the convex surface transitions to a concave transition region 28, which in turn abuts the terminal portion 14 of the prong 11. In the embodiment shown, the profile of the concave region 28 has a chord circle so that the profile is achieved at a constant height around the prong 11.

[0198] This gradual taper, along with the increased prong wall thickness in the nostril sealing area, also helps to tip the nasal prong 11 back over if it becomes inverted or collapsed, and helps to bias the nasal prong into its in-use configuration.

[0199] Figures 32 to 36A An alternative embodiment of the nasal mask 105 is shown in which each nasal prong 111 includes a web 145 to further reduce the possibility of the nasal prong 111 flipping or tipping over. In this embodiment, unless otherwise described, the seal is substantially as described with respect to the first embodiment, and like reference numerals are used to represent like parts, but increased by 100.

[0200] The web 145 is a thin member comprising a flexible elastic material, preferably the same material as the prongs, such as silicone. The web 145 may be integrally formed with the nasal mask 15 such that the web 145 is continuous with the inner wall of the prongs 111.

[0201] Each web 145 is located within the interior cavity 112 of the corresponding nose prong 111. Fig.33B and Fig.34B As shown, the web 145 is roughly aligned with the minor axis of the corresponding fork opening, or is spaced apart from and roughly parallel to the minor axis. In other words, the web 145 is substantially perpendicular to the major axis of the corresponding fork opening. The two forks are not co-linear, but angled toward each other.

[0202] Each web 145 extends from the inner surface of the wall of the yoke 111, extending across the cavity to opposite points on the inner surface of the yoke wall. The edges and corners of the web 145 at the transition to the inner wall of the yoke are rounded or chamfered to form a more gradual attachment and reduce potential stress concentrations when the web is under tension. This reduces the possibility of the web 147 separating from the corresponding yoke wall or the web itself tearing.

[0203] like Fig.35 and Fig.36A As shown, in the embodiment shown, each web 145 has a bottom edge near the base of the fork 111. The web does not extend completely to the tip of the fork 111, but the web has a depth WD between the lower edge and the upper edge, which is shorter than the fork depth, so that the upper edge of each web 145 is positioned in the fork cavity, spaced apart from the tip 111a of the fork. In one embodiment, the forks all have an average height of about 10.1mm, and the average height of the corresponding web is about 3.2mm, and the distance between the upper edge of the fork and the upper edge of the web is about 4.3mm. In other words, the height of the web is about 0.3 times the height of the fork. In alternative embodiments, the height of the web relative to the fork can be different, for example, 0.2 to 0.6 times the height of the web, or 0.25 to 0.4 times the height of the web.

[0204] The termination of the web 145 before the tip 111a of the prong 111 advantageously ensures that the web does not unduly increase the stiffness at the tip of the prong. Thus, when the tip of the prong 111 contacts the nostril of the user during use, it is still able to conform to the contour of the nostril. The web 145 does not increase discomfort by creating a hard or rigid area that transfers loads to the patient's nostril.

[0205] Each web 145 has a selected thickness to provide adequate structure to the prongs while minimizing discomfort to the wearer. Preferably, the presence of the web 145 should not be noticeable to the user. In the illustrated embodiment, the webs 145 each have a thickness of approximately 0.5 mm. However, in alternative embodiments, the web thickness may be less than or greater than 0.5 mm, such as between about 0.4 mm and about 0.6 mm, or between about 0.3 mm and about 0.8 mm.

[0206] Reference Fig.35In a cross-sectional view of the fork, each web 145 has a width WW that is slightly greater than the straight-line distance between the two opposing inner surfaces of the inner wall of the fork on the minor axis or plane. That is, the web does not extend linearly between the two surfaces, but has a slight curvature. This curvature enables the fork 111 to be compressible in both the secondary and primary directions. Compression in the primary direction causes the web to stretch and straighten across its width, thereby flattening and tensioning the web 147. Compression in the secondary direction causes the curvature of the web 147 to increase. Because the web 147 is already slightly curved in the initial state, this ensures that further bending / bending of the web is predictable and controlled, rather than causing ripples or irregularities along the web.

[0207] The web width WW and the length of the upper edge do not have to be the same measurement. The web width is usually measured at a point along the web between the lower edge and the upper edge. Due to the tapering of the fork, the upper edge may therefore be shorter than the web width, but alternatively the upper edge of the web may be curved or shaped so that it is longer than the web width WW.

[0208] In alternative embodiments, the nose yoke webs 147 may be oriented in other ways, for example, they may extend in a direction that is not parallel to the minor axis. For example, the webs may be generally disposed along the major axis, or at an angle between the minor axis and the major axis. However, the webs should always extend across the yoke cavity, attached to surfaces on opposite sides of the cavity. Webs oriented generally parallel to the minor axis advantageously improve ease of manufacturing and processing, because the nose seal 105 may be molded using a single 2-piece mold core.

[0209] In an alternative embodiment, each web 145 may extend completely to the tip 111a of the tine. However, while a web located at the tip of the tine may provide additional structure, it is not necessary to prevent the tine from tipping over. In addition, an inverted tine may be easier to maintain in the inverted position because in an embodiment where the web is located at the tip of the tine, stability is provided in both the original position and the inverted position.

[0210] FIG. 36B to FIG. 36E An alternative embodiment nose seal 805 is shown according to an alternative embodiment, wherein each nose prong 811 includes a web 845. Unless otherwise noted, the seal 805 is substantially as described with respect to Figures 32 to 36A The nasal seal 105 is described above, wherein like reference numerals are used to indicate like parts but increased by 700.

[0211] In this embodiment, the nose seal web 845 is formed to have a center portion and two side portions 846. The web 845 has a bottom edge proximate the base of the prongs 811. In the center portion, the web 845 has a depth that is shorter than the depth of the prongs so that the upper edge of the center portion of the web 845 is positioned within the prong cavity, spaced from the tips 811a of the prongs. The height of the web in the center portion is substantially the same as the height of the web in the seal 105 of the previous embodiment.

[0212] The side portions 846 of the web extend along the inner surface of the prong wall toward the tip 811a of the prong wall 811 and abut the inner surface of the prong wall. In the embodiment shown, the side portions extend completely to the tip of the prong, however in alternative embodiments, the side portions may terminate before the tip of the prong. The width of the side portions tapers along the length of each side portion, narrowing toward the tip 811a of the prong, so that the distance x between the inner edges of the two side portions at or near the tip 811a of the prong 811 is greater than the distance y between the two inner edges of the side portions at the base of the side portions at or near the upper edge of the center portion.

[0213] The web includes an upper edge. The upper edge has a center portion forming an upper edge of the web center portion and side portions forming inner edges of the web side portions. The upper edge may include one or more curved portions to form a smooth transition between the upper edge center portion and the upper edge side portions and / or to form a smooth transition between the upper edge side portions and the inner surface of the yoke wall. In the illustrated embodiment, the transition between the upper edge center portion and the upper edge side portions and the transition between the upper edge side portions and the nose yoke wall include rounded corners.

[0214] In the illustrated embodiment, a first one of the upper edge side portions is longer than the other upper edge side portion, and the second side portion is longer than a central portion of the upper edge of the web.

[0215] In the illustrated embodiment, the length of the first upper edge side portion is between about 3.8 mm and about 4.7 mm, while the second upper edge side portion is between about 3.3 mm and about 4.4 mm. However, in alternative embodiments, the side portions may have other lengths, or may have the same length. The center portion of the upper edge is about 3.3 mm, but may alternatively be between about 2.3 mm and about 3.8 mm, or any other suitable size.

[0216] The termination of the central portion of the web 845 before the tip 811a of the prong 811 advantageously ensures that the web does not excessively increase the stiffness at the tip of the prong, while the tapered side portions eliminate undercuts to provide ease of molding. In the illustrated embodiment, the side portions have a taper of about 5 degrees to facilitate tool removal and reduce tool wear. However, in alternative embodiments, the taper can be less than or greater than 5 degrees, such as between about 1 degree and about 35 degrees.

[0217] FIG. 36F to FIG. 36I Shown is the method for forming FIG. 36B to FIG. 36E A molded part of the nose seal 805. Fig.36H and Fig.36I As shown, the web 845 can be formed by using the upper mold cavity part 882a and Fig.36F and Figure 36G The mold core 880 and the lower mold cavity part 882b are formed together. The upper mold cavity part 882a includes a tapered protrusion protruding from the tip of the prong into the prong cavity, the end of the protrusion defining the upper edge of the central portion of the web 845. This enables the prong to be manufactured using a single piece of the core 880. The taper on the protrusion enables easy removal of the upper mold part 882a after molding.

[0218] The webs 145, 845 in the illustrated embodiment are substantially flat thin members. However, in alternative embodiments, the webs may have alternative forms, for example, rods, strips, ribs or membranes linking opposing walls.

[0219] Now referring back to the first embodiment and Figure 8 , the nose seal 5 defines a fluid inlet 17, which is a generally D-shaped opening that is widest at a base 21 of the opening and narrowest at a top 22 of the opening. This opening shape accommodates the orientation and positioning of the nose prongs 11 to ensure that fluid flows directly through the prong cavities 12. For example, the outer edges of the nose prong cavities 12 are further apart at the base of the nose seal 5 than at the top. Figure 8 As shown, in front view, the opening of the nose tine cavity 12 at the tip 11a of the nose tine is substantially within (behind) the perimeter of the D-shaped inlet 17, thereby allowing fluid to flow directly from the inlet 17 through the nose tine opening.

[0220] In the embodiment shown, both the top edge 21 and the bottom edge 22 of the inlet 17 are curved in a concave manner (the top edge 22 is curved at Figure 8 The inlet side 23 is shown in the figure (hidden by the pull tab 25), wherein the angled side 23 extends at an angle from the respective ends of the top edge 21 and the bottom edge 22. The inlet side 23 is substantially linear in a rear view or a front view.

[0221] The corners of the opening 17 where the side 23 intersects the respective top edge 21 and bottom edge 22 are rounded to avoid stress concentrations. The rounding also allows for some misalignment between the frame and the seal opening 17 to prevent small misalignments from adversely affecting the sealing performance. In an exemplary embodiment, the width of the top of the opening 22 is about 15 mm, and the width of the bottom of the opening 17 is about 27 mm, with a maximum distance between the top of the opening and the bottom of the opening being about 22 mm. It should be understood that these dimensions may vary depending on the size or geometry of the nasal seal and / or the frame geometry.

[0222] The side profile of the side edge 23 of the nose seal inlet 17 is arcuate. Fig.10 As shown, the arc is concave relative to the front of the seal 5 and has a constant radius r of about 25 mm. I and a center of curvature 24 in front of the seal 5 .

[0223] like Fig.11 As shown in the cross-sectional view of FIG. 1 , an inwardly extending lip 20 is provided at the fluid inlet opening 17 for engaging the support frame 3. The lip 20 is an area of ​​increased wall thickness around the periphery of the inlet 17, defining edges 21, 22, 23 of the inlet 17. The lip 20 facilitates engagement with the frame by deforming the seal around a portion of the frame, as will be described in more detail below. In the embodiment shown, the lip 20 has a depth of approximately 3 mm, however this may vary between embodiments.

[0224] A pull tab 25 is provided at the top of the nasal seal 5, projecting rearwardly adjacent the fluid inlet 5. The pull tab 25 provides an intuitive gripping surface for the user, and may include a thickened front edge or a ribbed or otherwise textured surface to provide the user with more grip when pulling the seal onto the frame 3, as will be described in more detail below.

[0225] Figures 15 to 24 A frame 3 is shown to which the above-mentioned nasal seal 5 is connected. The frame 3 defines a fluid chamber 4 having an inlet 15 and an outlet 16 for fluid communication with an inlet 17 of the nasal seal. The frame includes a collar located at the inlet 15 for coupling to a fluid conduit 9. The inlet 15 may include a tube retaining recess to enable the end of the conduit 9 to be rotatably attached to the tube retaining recess, for example using a snap-fit ​​mechanism, so that the conduit 9 can rotate freely relative to the frame 3. In the embodiment shown, the frame inlet 15 has a diameter of approximately 15 mm to be compatible with existing fluid conduits, however, other inlet sizes are contemplated.

[0226] The outer surface of the frame adjacent the frame outlet 16 forms a generally D-shaped seal retention rim that is complementary to the D-shaped opening of the nasal seal fluid inlet 18. The seal retention rim includes an upper surface, a lower surface, and two opposing side surfaces extending between the upper surface and the bottom surface. Outwardly projecting flanges 29, 31 are disposed adjacent to the outlet 16 along the rear edges of the upper and lower surfaces of the seal retention rim, extending substantially along the entire upper or lower surface. The width of the upper flange 29 is narrower than the width of the lower flange 31, consistent with the wider lower edge of the D-shaped opening.

[0227] The fluid inlet 17 on the nose seal 5 is configured to be received over the seal retaining rim at the frame outlet 16. The bottom flange 31 on the frame is engaged with the nose seal at the fluid inlet 17 by placing the lower flange 31 through the inlet 17 and "hooking" the flange 31 behind the lower lip 21a on the nose seal 5. In this way, the front surface of the lower flange 31 abuts the rear surface of the lip 20 at the bottom of the seal inlet 17. The flange 31 protrudes a distance substantially corresponding to the depth of the lip 22, so that most of the lower lip abuts the lower flange 31. In the embodiment shown, both the top flange 29 and the bottom flange 31 protrude by approximately 1 mm (see Fig.26 ). The top flange 29 and the bottom flange 31 have rounded edges to assist their insertion into the seal inlet 17 and also to avoid accidental damage to the seal which could occur during assembly and disassembly if sharp edges were used.

[0228] The long engagement surface provided by the lower flange 31 makes lower flange insertion into the seal inlet 17 achievable for a range of users, including those with impaired fine motor skills or visual impairment. Additionally, the long lower flange aligns the seal 5 with the frame 3 for the second assembly stage.

[0229] In the next step, once the lower flange 31 is engaged with the lip 20, the user grasps the pull tab 25. Using the pull tab 25, the user pulls the nasal seal 5 upward, moving the fluid inlet 17 over the frame outlet and the top flange 29. The top flange positively engages the nasal seal 5 by "hooking" behind the upper lip 22. In this way, the front surface of the upper flange 29 abuts the rear surface of the lip 20 at the top of the seal inlet 17. The flange 29 protrudes a distance substantially corresponding to the depth of the lip 22 at its top portion, so that most of the top lip abuts the top flange 29.

[0230] The frame 3 has a pull tab alignment surface 26 that is aligned directly below the pull tab 25 when the mask 1 is assembled. The pull tab alignment surface 26 serves as a visual cue for the user to aid in the proper assembly and alignment of the seal 5. When the D-shaped opening of the seal is aligned with the D-shaped rim of the frame and the upper and lower flanges 29, 31 engage with corresponding portions of the lip 20 on the nasal seal 5, the pull tab 25 will be positioned directly above the pull tab alignment surface 26. The "D" shape of the connection aids in alignment between the nasal seal 5 and the mask frame 3 to prevent improper assembly and improve ease of use.

[0231] like Figure 3 and Figure 5 As shown, when the mask is assembled, the pull tab 25 does not rest on the pull tab alignment surface 26, but there is a gap between the alignment surface 26 and the lower surface of the pull tab 25. This gap allows the user to place their fingers under the pull tab 25 to easily grasp the pull tab 25, thereby pulling the seal upward and backward over the top flange 29 to remove the nose seal 5 from the frame 3. In addition, the pull tab 25 can have additional visual features to enhance its visibility. In the embodiment shown, the pull tab 25 includes a large "M" mark to indicate the mask size, but other visual features or tactile features for improving grip can be envisioned. The pull tab also helps to identify the top of the mask, making the assembly of the mask more intuitive and reducing the occurrence of users incorrectly assembling the mask upside down.

[0232] When the nose seal 5 is assembled with the frame 5, the sides of the lip 20 on the nose seal 5 abut the corresponding sides of the seal retaining rim on the frame 3. The engagement between the sides 23 of the lip 20 and the sides of the seal retaining rim is Fig.26 Shown in.

[0233] In the embodiment shown, the opening 17 in the nose seal 5 is slightly smaller in the static state than the seal retaining rim of the frame 3 on which the opening 17 is seated. This ensures that the seal 5 remains taut over the frame 3 to provide a tighter seal with the frame 3. The side lips 23 on the nose seal opening are thereby maintained in contact with the sides of the rim 32 at the frame outlet 16.

[0234] For example, in the embodiment shown, there is about 0.3 mm overlap / interference - about 10% of the seal lip thickness (3 mm). In the embodiment shown, the nose seal 5 comprises a single durometer silicone material (Momentive Silicone Rubber 4840) so that when attached to the frame, the thicker lip area will create higher tension than the surrounding thinner wall area.

[0235] The upper and lower flange engagement and the tension in the lips 21, 22, 23 of the seal inlet 17 hold the nasal seal 5 to the frame 3 to prevent the nasal seal 5 from slipping off the frame 5 even under high treatment pressures. Advantageously, no additional components are required to attach the seal 5 to the frame 3. This reduces component complexity and overall cost.

[0236] like Fig.25 and Fig. 27 As shown, when the top and bottom regions engage the respective flanges 29, 31, the tension applied to the top and bottom regions helps to pull the side lips 23 inwardly into contact with the adjacent frame surface to ensure a good airtight seal between the lips 20 of the nose seal 5 and the seal retaining edges on the frame 3. However, this results in a force acting on the nose seal 5 to pull the seal forward into contact with the rear surface of the frame arm 13. As shown in FIG. Fig.30 As shown, the rear surface of the frame arm 13 (where the arm contacts the seal 5) is a convex with a radius of 25 mm to complement the arcuate side profile of the above-mentioned seal opening 17 (see Fig.25 The frame arms provide a reaction force against the forward pull of the seal, resulting in a reaction force F in the side areas of the nose seal opening 17. R The arcuate profile of the seal opening 17 and the complementary shape of the frame arm surface distribute forces evenly around the seal opening. Alternatively or additionally, a small rib or bead may be provided along at least a portion of the seal retaining rim engagement feature to engage with a complementary recess on the seal, or vice versa.

[0237] The nose seal 5 can be easily removed from the frame by reversing the above process. That is, before removing the lower flange 31 from the fluid inlet 17 and disengaging it from the seal lip 20, grasp the pull tab 25 and pull the pull tab upward and rearward to pull the seal out of engagement with and over the top frame flange 29.

[0238] The mask frame 3 features headband coupling arms 13 that extend laterally from the frame adjacent to the sides of the frame inlet 15 and that, at least in a static, non-use state, substantially follow the contour of the body of the nasal seal 5 without contacting the body of the nasal seal 5. The resulting gap between the sidewalls of the seal 5 and the inner surface of the frame arms 13 allows the nasal seal 4 to move when pressed against or into the wearer's nose. This enhances the cushioning effect of the seal and reduces pressure on the nose, especially under higher forces applied by the headband.

[0239] The coupling arms 13 have coupling features configured for attaching the frame 3 to a headband. In the embodiment shown, the arms each have a hole 35 at the distal end of the arms 13, forming a post 36 for receiving the headband 7.

[0240] The headband coupling arms 13 are angled relative to the nasal seal and frame so that reaction forces from the headband 7 are substantially evenly distributed across the attached nasal seal to ensure stability and proper positioning of the nasal seal 5 in use.

[0241] In the illustrated embodiment, the distal end of the link arm 13 is formed to allow the post 36 to be perpendicular to the headband force and for proper seal positioning. This is achieved by a post angle offset of approximately 11.8° relative to the vertical axis in the exterior / front view and 10° in the side view. Due to the angle of the frame inlet 15, as shown Figure 2 , Fig.22A , Fig. 22B As shown, these views are not perpendicular to the cross-section of the tube connection features.

[0242] like Figure 2 As shown, the axis perpendicular to the headband connection post 36 is offset at an angle of approximately 50° from the farthest surface of the tube connection feature. This angling of the frame 3 and subsequent nasal seal 5 guides the seal upward into the user's nostrils to help achieve a correct fit and a good seal.

[0243] The frame arm 13 is thickest in the portion of the coupling arm 13 adjacent the frame inlet 15 and the thickness decreases towards the distal end of the arm 13. In the embodiment shown, the thickness decreases from approximately 4mm to 2mm towards the free end of the arm.

[0244] In this embodiment, the total maximum width of the frame including the connecting arms 13 is 57mm. Preferably, when assembled, the length of the wings 13 does not extend behind the rear surface of the nasal seal. This contributes to the small and unobtrusive nature of the mask 1.

[0245] In addition to the simple two-part assembly described above, the frame 3 and nasal seal 5 are configured to reduce processing and manufacturing costs. For example, the mask frame 3 may not include undercuts to ensure that it is suitable for a two-part molding process, for example, the seal retaining edge on the frame 3 is angled inwardly away from the mask headband retaining arm 13. Although an outwardly angled edge can achieve an excellent seal, it is avoided because it will produce an undercut. In addition, for ease of manufacturing, it is preferred that the mask frame 3 also does not feature any large thickness changes or sharp corners; all edges and transitions between surfaces are smooth to avoid sinks that may form during the molding process.

[0246] For the nose seal 5, the orientation of the seal in the mold is ideally chosen to aid in removing the seal 5 from the mold. For example, in the pulling direction of the seal. The pull tab 25 on the nose seal advantageously aids in removing the seal 5 from the mold. Undercutting is less of a concern for the seal because the seal is made of a flexible, resilient material such as silicone.

[0247] The frame 3 includes a series of flow deviation holes 33 adjacent to the inlet 15, thereby forming a diffuser. The flow deviation holes 33 are arranged in two symmetrical arc-shaped rows on opposite sides of the inlet 15, each arc-shaped row having 13 holes. These rows can be concentric with the inlet 15. In alternative embodiments, these rows can contain more or fewer holes.

[0248] In the embodiment shown, the bias holes 33 are substantially cylindrical, having a diameter of 0.7 mm, a spacing of 1.2 mm (between the centers of adjacent holes), and adjacent holes are angularly spaced at an angle of 6.9 degrees. At the surface of the frame, the holes have rounded or tapered edges provided by fillets or as a result of the manufacturing process. These holes 33 are arranged at a turning area defined by fillets 34 formed between the catheter collar at the frame inlet 15 and the body of the frame 3 extending into the headband connecting arm 13. In particular, the bias holes 33 are located 1.5 mm from the outer edge of the turning profile. In the embodiment shown, the bias holes are formed by laser cutting in the frame 3.

[0249] The axes of the bias holes 33 are perpendicular to the outer surface of the contoured area. Therefore, their positioning on the chamfered surface 34 means that the bias holes 33 are angled to direct the airflow away from the surface of the mask (so as not to impinge on any surface of the frame) and away from each other, rearwardly and outwardly. This arrangement produces minimal sound during CPAP therapy while advantageously directing the airflow away from the user's face and eyes and rapidly diffusing the air. The projected axes of the bias holes 33 do not all intersect at a single point, but the axis of a given hole will intersect the axes of other bias holes at different points behind the holes.

[0250] In alternative embodiments, the respiratory mask may include one or more alternative features instead of or in addition to the diversion holes to diffuse the airflow from the exhaled air and reduce the associated noise. Fig.37 An alternative embodiment frame 103 is shown for a respiratory mask 101. The frame 103 is substantially as described with respect to the first embodiment frame 3 except as described below. Like reference numerals are used to denote like parts, but with 100 added.

[0251] In this embodiment, two diffusion holes 133 are provided in the mask frame 103 near the lower portion of the inlet on the left and right sides of the frame inlet 115. In the embodiment shown, the holes 133 are substantially triangular in shape to fit the space available in the lower portion of the frame 133 between the frame inlet 115 and the outer periphery of the body of the frame 103.

[0252] The diffuser 133 is in fluid communication with a fluid chamber defined by the frame 103 to allow air exhaled into the chamber by a user to flow out through the diffuser 133. The diffuser 133 directs the exhaled air in a forward direction F, thereby reducing the amount of air flow that strikes the user's face.

[0253] An air permeable diffuser pad 150 extends across each diffuser hole 133 to diffuse the air flowing through the diffuser hole and reduce noise levels. The diffuser pad material can be attached to the frame by overmolding, or otherwise permanently or removably attached to the frame 103. The diffuser pad can include a fibrous material or fabric. In one embodiment, the diffuser pad 150 includes hydrophobic and hydrophilic felt fibers interwoven by needle punching.

[0254] Preferably, the pads are attached or bonded to the frame 103. Alternatively, the entire frame 103 may be formed together with the diffusion pad(s) using an overmolding process and a two-part mold. Figures 58 to 60 A method of forming a diffuser pad 150 comprising felt fibers is shown. Fig.58 As shown, a felt pad 150 having a substantially constant thickness is provided. The pad 150 is slightly larger than the diffuser hole size to allow the edge of the pad 150 to be bonded to the nasal seal frame 103. The pad 150 is placed into a two-part mold 181, 183 that is shaped to compress the diffuser pad 150 around the portion to be positioned in the hole at the hole periphery to form a compression boundary 150a, as shown in FIG. Fig.60 As shown, the frame 103 is then molded (e.g., injection molded) using the same mold. The portion of the mold that compresses the diffuser pad prevents the frame material from flowing into the diffuser holes. The uncompressed edge 150b of the diffuser pad that exceeds the compressed portion 150a is overmolded with the frame 103, as shown. Fig.60 As shown. The edge fibers of the diffusion pad 150 are suspended in the rigid plastic of the frame 103, thereby fixing the diffusion pad 150 in the frame 103. In alternative embodiments, the diffusion holes 133 may have other shapes, for example, these diffusion holes may include slots, circular or other shaped openings. There may be fewer or more diffusion holes, for example, multiple holes may be set on each side of the inlet 115. Each diffusion hole can have a separate diffusion pad, or a single pad can extend across several diffusion holes. For small holes, such as the bias hole 33 in the first embodiment, a diffusion pad may not be needed.

[0255] Instead of providing a plurality of diffusion holes in a lower portion of the frame, the diffusion hole and the diffusion pad may be provided in a top portion of the frame. Fig.39 and Fig.40 An embodiment frame 203 is shown having a diffuser hole 233 positioned just above the mask frame inlet 215. The frame 103 is substantially as described with respect to the previous embodiment frame 103 unless otherwise described. Like reference numerals are used to denote like parts but increased by 100.

[0256] The diffuser 233 is generally rectangular and is centrally disposed on the frame 203, directly above the inlet 215, with the long dimension of the rectangle oriented horizontally. The diffuser 233 may be other shapes, for example, it may be oval, circular, trapezoidal, or any other suitable shape.

[0257] Fig.40 The mask frame 203 is shown oriented when worn by a user. As shown, the diffuser holes 233 direct air to flow generally forward and upward through the holes, away from the user's face, so as not to cause irritation or discomfort to the user. Figure 7 When the seal 3 is assembled on the frame 203, the pull tab 25 of the seal 3 partially extends above the diffuser hole 233. The pull tab 25 also helps to guide the air flow from the diffuser hole 233 in the forward direction.

[0258] As described above, the diffusion pad schematically shown by line 250 extends through the diffusion hole 233 to diffuse the air flowing through the diffusion hole 233 and reduce noise. The diffusion pad 250 can be as described above with respect to Figures 37 to 38B The inner surface of the diffusion pad may be substantially flush with the inner surface of the frame 203.

[0259] FIG. 41A to FIG. 42 Another embodiment frame 303 is shown having a diffuser hole 333 positioned adjacent to the top frame flange 329. Unless otherwise noted, the frame 303 is substantially as described with respect to the previous embodiment frame 203. Like reference numerals are used to denote like components, but increased by 100.

[0260] The diffusion hole 333 opens to the front of the frame 303, is located adjacent the frame outlet, and is in fluid communication with the chamber formed by the attached seal 305 between the frame 303 and the user.

[0261] The surface of the frame 303 adjacent to the diffusion hole 333 extends generally forward from the base of the hole 333 and slopes downward. A plurality of diverging linear grooves 229 are provided on the adjacent frame surface to help disperse the exhaled air. Fig.42As shown, the rear end of each groove 338 is connected to the diffuser hole 333, so that the groove 338 forms a channel that is in fluid communication with the diffuser hole and the chamber formed by the nose seal 305. Fig.42 As shown by the arrows in , the grooves 338 diffuse the airflow from the diffusion hole across a wider area than the diffusion hole 333 and direct the airflow away from the user's face.

[0262] The top edge of the nasal seal inlet engages the top flange 329 of the frame 303, and the top edge of the nasal seal inlet and the pull tab 325 at least partially cover the diffuser hole 333 (see FIG. Fig.41B ). The pull tab 325 extends forward over at least most of the groove 338. Thus, at least most of the exhaled airflow flows along the channel defined by the groove 338. The lower surface of the pull tab 325 can contact the surface of the frame 303 so that substantially all of the airflow out of the diffuser hole follows the channel formed by the groove (and further defined by the lower surface of the pull tab 325).

[0263] The lower surface of the pull tab 325 also prevents air from flowing upward and backward toward the user's face.

[0264] Fig.43A and Fig.43B Another respiratory interface 401 is shown in which a diffuser is provided at the connection between a frame 403 and a fluid conduit 409. Unless otherwise described below, the frame 403 is substantially as described with respect to the first embodiment frame 3. Like reference numerals are used to denote like parts but with 400 added.

[0265] In this embodiment, the conduit 409 is overmolded to the connector 451, or otherwise permanently or removably attached to the connector. The connector 451 has an engagement feature 453 for removably connecting to the inlet 415 of the frame 403, such as by snap-fit ​​engagement. In the illustrated embodiment, the engagement feature comprises a snap-fit ​​flange that engages a complementary annular recess provided on the frame inlet 415. Compared to the conduit 409, the connector 451 is substantially rigid, for example, it may comprise nylon, another plastic, or a composite material.

[0266] The catheter 409 is overmolded to the front portion of the connector 451, or otherwise permanently or removably attached to the connector. Compared to the catheter, the connector 451 is substantially rigid, for example, it may include nylon, another plastic, or a suitable composite material.

[0267] A plurality of diffusion holes 433 are provided on the connector 451 adjacent to the engagement feature 453. In the illustrated embodiment, the diffusion holes 433 comprise a row of elongated slots arranged annularly around the connector. However, the diffusion holes may be alternatively shaped or arranged. When the connector 451 is engaged with the frame inlet 415, the diffusion holes are located in front of the frame 405 and are not covered by the frame inlet 415. This allows exhaled air to escape through the diffusion holes 433.

[0268] The annular air-permeable diffuser pad 450 is positioned over the connector 451 at the diffuser hole 433 so that the pad 450 covers the diffuser hole to diffuse the airflow out of the hole. Fig.43B As shown, when assembled, the diffuser pad 450 is sandwiched between the mask frame inlet 415 and the overmolded conduit connector to diffuse the airflow from the diffuser holes.

[0269] Figures 44 to 48 Another embodiment frame 503 for a respiratory interface is shown. In this embodiment, the frame 503 is a two-part component including a body and a removable diffusion clip 551. The ability to separate the diffusion clip and the body of the frame allows for easy replacement of the diffusion material by replacing the diffusion clip 551. Except as described below, the frame 503 is otherwise substantially as described with respect to the frame 3 of the first embodiment. The same reference numerals are used to represent the same components, but with 500 added.

[0270] The diffusion clip 551 forms a front portion of the mask frame 503, including defining the frame inlet 515. Rearwardly extending attachment clips 553 are provided on the left and right sides of the diffusion clip 551 to removably engage the diffusion clip 551 to the front side of the body of the frame 503. Both attachment clips 553 include a protruding angled lip to engage a complementary recess or lip 554 on the frame body and are spaced from the outer edge of the diffusion clip 551. In the illustrated embodiment, a slot 557 is provided in the arm of the frame 513 (see FIG. Fig.46A ) to receive the attachment clip 553, each slot defining a complementary recess or lip 554 for engaging with a corresponding attachment clip 553. The slots are positioned on the left and right sides of the perimeter of the breathing chamber defined by the frame so that the slots 553 are not in direct fluid communication with the chamber.

[0271] When the diffusion clip is engaged with the body of the frame, the rear surface of the diffusion clip 551 adjacent the clip perimeter is substantially flush with the front surface of the body to form a tight seal between the two components, thereby minimizing any air leakage.

[0272] The diffusion clip 551 includes diffusion holes 533 located on the left and right sides of the mask frame inlet 515. In the illustrated embodiment, the holes 533 are substantially triangular, however, in other embodiments, the diffusion holes can be other shapes, for example, they can be circular, rectangular, irregular, or can include multiple slots.

[0273] The diffusion holes 533 are in fluid communication with the fluid chamber defined by the support frame 503 to allow air exhaled into the chamber by the user to flow out through the diffusion holes. An air permeable diffusion pad 550 extends across each diffusion hole 553 to diffuse the air flowing through the diffusion hole 553 and reduce noise levels. The diffusion pad material can be attached to the diffusion clip 551 by overmolding, or otherwise permanently or removably attached to the diffusion clip 551.

[0274] Figures 49 to 52 Another embodiment frame 603 and conduit connector 651 for a respiratory interface is shown. Unless otherwise described below, the frame 603 is substantially as described with respect to the first embodiment frame 3. Like reference numerals are used to denote like parts, but with 600 added.

[0275] In this embodiment, the diffusion feature is provided on a connector 651 that attaches a conduit (not shown) to the frame 603. The connector 651 has an engagement feature 653 at the rear of the connector to removably or permanently couple to the inlet 615 of the frame 603, such as by a snap-fit ​​engagement. In the embodiment shown, the engagement feature includes an annular snap-fit ​​flange that engages with a complementary annular recess provided on the interior of the frame adjacent the frame inlet 615. When engaged, the connector 651 can rotate about the central axis.

[0276] A catheter (not shown) is overmolded to the front portion 654 of the connector 651 or otherwise permanently or removably attached to the connector. The connector 651 is substantially rigid compared to the catheter, for example, it may comprise nylon, another plastic, or a suitable composite material.

[0277] A plurality of diffusion holes 633 are provided on the connector 651 adjacent to the engagement features 653. In the illustrated embodiment, the diffusion holes 633 comprise a row of elongated slots arranged annularly around the connector. However, the diffusion holes may be alternatively shaped or arranged. An annular air-permeable diffusion pad (not shown) is positioned above the connector 653 at the diffusion holes 633 such that the pad covers the diffusion holes to diffuse the airflow out of the holes.

[0278] The frame 605 includes one or more air barrier tabs 657a, 657b extending forwardly from the frame adjacent the inlet 615. When the connector 653 is engaged with the frame inlet 615, the diffuser holes 633 are located forwardly of the inlet 615 but behind the front edges of the air barrier tabs 657a, 657b and are not covered by the frame inlet 615. A diffuser pad is sandwiched between the mask frame inlet 615 and the tube overmolded connector to diffuse the airflow from the diffuser holes.

[0279] The air barrier tabs 657a, 657b are arcuate tabs having a curvature concentric with the frame inlet 615. These tabs are spaced apart to define radial cutout gaps 657 between adjacent tabs. When the connector 653 is engaged with the frame inlet 615, some diffusion holes 633 are positioned behind the air barrier tabs 657a, 657b, while other holes 633 are positioned in the gaps 657. The air barrier tabs 657a, 657b extend above the corresponding diffusion holes to prevent airflow from flowing out of those holes. The diffusion holes 633 in the gaps 657 between the tabs remain exposed so that air can flow freely out of these holes and the frame 603.

[0280] The air barrier tabs 657a, 657b prevent exhaled air from being directed in directions that may cause annoyance or discomfort to the user, such as toward the user's face. The illustrated embodiment includes an upper air barrier tab 657a that blocks upward airflow, which may otherwise be directed toward the user's face during adjustment of the interface, and a lower air barrier tab 657b that blocks downward airflow, which may otherwise be directed toward the user's face during adjustment of the interface, and a lower air barrier tab 657b that blocks downward airflow. The lower air barrier tab 657b is longer (e.g., 2 to 4 times longer) than the upper air barrier tab 657a and extends partially upward to the left and right sides of the inlet 615.

[0281] Figure 53 to Figure 57 Another embodiment frame 703 for a respiratory interface is shown. Unless otherwise described below, the frame 703 is substantially as described in relation to the first embodiment frame 3. Like reference numerals are used to denote like parts, but with 700 added.

[0282] The frame includes a diffusion hole 733 located directly above the mask frame inlet 715.

[0283] The diffusion hole 733 is generally rectangular and is centrally disposed on the frame 703, directly above the inlet 715, with the long dimension of the rectangle oriented horizontally. The diffusion hole 733 can be shaped in other ways, for example, it can be elliptical, circular, trapezoidal, or any other suitable shape. Compared to the previously described embodiments, the upper area of ​​the mask frame where the diffusion hole 733 is located is enlarged to allow a larger diffusion hole 733 to achieve a higher flow rate than those with a smaller frame and a smaller diffusion hole. In the illustrated embodiment, the diffusion hole 733 has a length of approximately 15 mm and a width of approximately 8.5 mm.

[0284] Reference Fig.57 , providing a larger upper area of ​​the mask frame by the increased angle between the frame inlet 715 and the frame outlet flanges 729, 731. In the illustrated embodiment, the angle is about 30 degrees. In the previously described embodiment, the angle is about 15 degrees. The larger angle brings the upper area of ​​the mask frame around the inlet 715 forward, increasing the depth of the frame, thereby increasing the area of ​​the mask frame available in the area above the inlet 715 and in front of the upper flange 729.

[0285] Diffusion pad 750( Fig.61 ) extends across the diffuser hole 733 to diffuse the air flowing through the diffuser hole 233 and reduce noise. The diffuser pad material can be attached to the frame by overmolding, or otherwise permanently or removably attached to the frame 703. Alternatively, the entire frame can be formed with the diffuser pad using an overmolding process and a two-part mold.

[0286] Figure 54 to Figure 56 A frame 703 is shown assembled with a nasal seal 705. A pull tab 725 on the nasal seal covers the rear portion of the diffusion pad and the diffusion hole 733. However, the front edge of the diffusion hole 733 is located further forward of the front edge of the nasal seal pull tab 725, so that the pull tab does not completely cover the diffusion hole, thereby not completely blocking the airflow. The preferred embodiments of the present invention are described only by way of example, and may be modified without departing from the scope of the present invention. For example, the above dimensions are provided as examples only and may vary in masks or seals of different sizes, or be made of different materials to take into account different material properties. In this embodiment, the nasal seal includes silicone and the mask frame is made of rigid nylon. However, it will be apparent to those skilled in the art that other elastomers or rigid materials, such as other plastics or composite materials, may be used instead without departing from the scope of the present invention.

Claims

1. A nasal seal for a respiratory therapy mask, the respiratory therapy mask being configured to contact a user's face, the nasal seal having a body defining a cavity and a fluid inlet, and comprising: two nasal prongs projecting from the body for delivering fluid to the nostrils of a user; and a transition fillet between the nose tine and the body about the base of each tine, wherein each transition fillet has a constant chord length.

Images