Nasal Mask System

Abstract

To provide alternative arrangements of mask systems to enhance the efficacy of therapy and compliance of patients with therapy.SOLUTION: A mask system comprises: a frame (20) adapted to attach headgear; a sealing arrangement (40) releasably connectable to the frame; and an elbow (70) provided to the sealing arrangement and adapted to be connected to an air delivery tube that delivers breathable gas to a patient. The sealing arrangement defines a breathing chamber and is adapted to form a seal with the patient's face. The sealing arrangement includes structure (50) to establish a positive connection with the frame and with the elbow.SELECTED DRAWING: Figure 1-2

Description

[Technical field]

[0001] [Application Cross Reference] This application claims the benefit of U.S. Provisional Patent Application Nos. 61 / 213,326, filed May 29, 2009, 61 / 222,711, filed July 2, 2009, 61 / 272,162, filed August 25, 2009, 61 / 272,250, filed September 4, 2009, 61 / 263,175, filed November 20, 2009, and 61 / 282,693, filed March 18, 2010, and Australian Provisional Patent Application Nos. 2009902524, filed June 2, 2009, and 2009906101, filed December 15, 2009, the disclosures of each of which are incorporated herein by reference in their entirety. Australian Provisional Patent Application No. (currently unknown, Attorney Docket No. C10110), filed May 28, 2010, is also incorporated herein by reference in its entirety.

[0002] The present invention relates to a nasal mask system for use in the treatment of sleep disordered breathing (SDB), for example, with continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV). [Background technology]

[0003] Patient interfaces, such as full face mask systems or nasal mask systems, used in conjunction with blowers and flow generators in the treatment of sleep disordered breathing (SDB), typically have a soft face-contacting portion, such as a cushion, and a rigid or semi-rigid shell or frame. In use, the interface is held in a sealing position by headgear so that a supply of air at positive pressure (e.g., 2 cmH2O to 30 cmH2O) can be delivered to the patient's airway.

[0004] One factor in the efficacy of a treatment and patient compliance with the treatment is the comfort and fit of the patient interface. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 7,000,614 [Patent Document 2] International Patent Application No. PCT / AU2009 / 000241 [Patent Document 3] International Patent Application No. PCT / AU2008 / 001557 [Patent Document 4] U.S. Patent Application Serial No. 12 / 379940 [Patent Document 5] US Patent Application Publication No. 2006 / 0201514 [Patent Document 6] US Patent Application Publication No. 2009 / 0050156 [Patent Document 7] U.S. Pat. No. 7,509,958 [Patent Document 8] International Patent Application No. PCT / AU2009 / 001605 [Patent Document 9] Australian Provisional Patent Application No. 2008906390 [Patent Document 10] Australian Provisional Patent Application No. 2009900327 [Patent Document 11] U.S. Patent No. 6,374,826 Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention provides an alternative configuration of a mask system that improves efficacy of and patient compliance with treatment. [Means for solving the problem]

[0007] One aspect of the present technology is to provide a mask system that is simple and unobtrusive. Another aspect of the present technology is a mask system that can accommodate a wide variety of face shapes, including high and low nasal bridge areas and narrow and wide noses. Another aspect of the present technology is a mask system that has a wide range of fit.

[0008] Masks according to the present technology can accommodate the relative impact of different sealing forces depending on the size and shape of the wearer's face and nose. In one form, the magnitude of the pulling force can be increased by spreading the undercushion outward.

[0009] One aspect of the present technology is a cushion for a mask that seals at its upper limit in the nose area generally near the junction between the bone and cartilage for a variety of people with large noses, without affecting the field of vision for people with smaller noses.

[0010] Another aspect of the present technology is a cushion for a mask having a thicker undercushion or back-up band that supports a thinner membrane or face flap. In one form, the cushion has an undercushion or back-up band that is relatively less stiff in the upper lip region than in the nasal corner region in a direction perpendicular to the plane of the person's face. In one form, the cushion does not have an undercushion or back-up band in its nasal bridge region. In one form, the undercushion or back-up band directs a sealing force against the sides of the nose in the nasal bridge region. In one form, the cushion is constructed and arranged such that when used by a person with a relatively deep nasal bridge, the sides of the cushion in the area of ​​the nasal bridge retract inwardly, increasing the force against the sides of the nose. In one form, when used by a person with a relatively low nasal bridge, the sides of the cushion in the area of ​​the nasal bridge flare outward. In one form, the undercushion is constructed and arranged to buckle. In one form, the undercushion has a C-shaped or sickle-shaped cross-section.

[0011] In one form, the sealing portion forming the surface of a cushion according to the present technology has a non-tacky surface. In one form, the sealing portion forming the surface of a cushion according to the present technology has a non-abrasive surface. In one form, the sealing portion forming the surface of a cushion according to the present technology has a matte surface finish.

[0012] The cushion of the present technology is adapted to form a seal around the patient's nose, including a seal at the patient's nasal bridge region, an area that has greater variability between different patients than other areas of the nose. Another area of ​​possible variability between faces is the angle of the forehead relative to the plane of the face.

[0013] A series of masks of various sizes and shapes can be constructed to accommodate a wide range of face shapes. However, this can be costly. In accordance with the present technology, a cushion angle adjustment mechanism can be provided for a mask system that facilitates rotation or orientation of the cushion relative to the plane of the face. In this way, a given mask system can accommodate a wider range of patient fits.

[0014] Cushion sizes and shapes can be configured to accommodate a wide variety of face shapes.

[0015] One aspect of the invention relates to a mask system having a frame adapted to mount headgear, a sealing mechanism releasably connectable to the frame, and an elbow on the sealing mechanism adapted to connect to an air delivery tube for delivering breathable gas to a patient. The sealing mechanism defines a breathing cavity and is adapted to form a seal with the patient's face. The sealing mechanism has a structure that establishes a secure connection with the frame and the elbow.

[0016] Another aspect of the invention relates to a mask system having a frame and a sealing mechanism on the frame. The sealing mechanism includes a silicone cushion and a foam cushion on the silicone cushion. The silicone cushion defines a breathing cavity, and the foam cushion is supported by the silicone cushion so as not to be in communication with the breathing cavity. The foam cushion supports the sealing mechanism on the frame.

[0017] Another aspect of the invention relates to a mask system having a frame adapted to attach headgear and a sealing mechanism releasably connectable to the frame, the sealing mechanism defining a breathing cavity and adapted to form a seal with a patient's face, the sealing mechanism having one or more protrusions adapted to mate with respective openings in the frame and providing visual reinforcement that a connection has been established.

[0018] Another aspect of the invention relates to a sealing mechanism for a mask system having a sidewall defining a breathing cavity, an undercushion curving outwardly from the sidewall and away from the breathing cavity, and a membrane at least partially covering the undercushion, the membrane extending from the undercushion and curving inwardly into the breathing cavity.

[0019] Another aspect of the invention relates to a mask system having a frame, a sealing mechanism releasably connectable to the frame, an elbow provided to the sealing mechanism and adapted to be connected to an air delivery tube that delivers breathable gas to a patient, and a forehead support provided to the frame. The sealing mechanism defines a breathing cavity and is adapted to form a seal with the patient's face. The forehead support has an elongated arm adapted to extend from the frame and an upper headgear connector adapted to attach an upper headgear strap, At least a portion of the arm can be constructed from metal.

[0020] Another aspect of the invention relates to a vent assembly for venting gas from a mask, the vent assembly having at least two vent arrays and a connecting structure joining the at least two vent arrays, each of the at least two vent arrays having at least one vent configured to vent gas from the mask, the connecting structure having a first position and a second position in which the at least two vent arrays are disposed at an offset angle from the at least two vent arrays when the connecting structure is in the first position.

[0021] Another aspect of the invention relates to a method of making a mask, comprising the steps of molding a vent structure, inserting the vent structure into a mold for a mask component, and molding the mask component over the vent structure, where molding the mask component aligns the vent structure to form air flow passages that reduce interference with exiting air flow during use.

[0022] Another aspect of the invention relates to a nasal mask defining a breathing cavity for delivering a supply of gas at a positive pressure to a patient's airway. The nasal mask has a sidewall and a cushion located adjacent the sidewall at a dorsal surface of the nasal mask. The rear sealing surface of the cushion has a contour at the upper lip region formed with a concave curvature to have a shape complementary to the upper lip region of the person. The contour of the rear surface of the cushion is constructed and arranged in use to extend along the respective left and right sides of the nose from the person's nasal bridge region located adjacent the junction between the nasal bone and cartilage to the left and right corner regions of the person's nose adjacent the left nasolabial crease and the right nasolabial crease, respectively. The contour of the rear sealing surface of the cushion is further adapted to extend from the left side of the nose to the right side of the nose along the person's upper lip. The cushion has a relatively thick backup band formed from a resilient flexible material and extending from the sidewall to form respective cantilevers at the upper lip region, corner region and nasal side region of the cushion. The cantilevers each have a length and a thickness and define a stiffness for each of the lip, corner and side of nose regions. The cantilevers in the corner regions are stiffer than the cantilevers in the upper lip region in a direction perpendicular to the plane of the face. The cushion further includes a relatively thin face flap. The face flap is inwardly curved and extends around the periphery of the cushion to define a posterior sealing surface of the cushion. An inner edge of the face flap defines an orifice through which a portion of the patient's nose passes in use.

[0023] Another aspect of the invention relates to a nasal mask defining a breathing cavity for delivering a supply of gas at a positive pressure to a patient's airway. The nasal mask has a sidewall and a cushion located adjacent the sidewall at a dorsal surface of the nasal mask. The rear sealing surface of the cushion has a contour at the upper lip region formed with a concave curvature to have a shape complementary to the person's upper lip region. The contour of the rear surface of the cushion is constructed and arranged to extend from the person's nasal bridge region to the person's left nasal corner region and right nasal corner region, respectively, along the left and right sides of the nose in use. The contour of the rear sealing surface of the cushion is further adapted to extend from the left nasal side to the right nasal side along the person's upper lip. The cushion has a relatively thick backup band formed from a resilient flexible material and extending from the sidewall to form respective cantilevers at the upper lip region, corner region and nasal side region of the cushion. The cantilevers at the upper lip region have a C-shaped cross section. The cushion further has a relatively thin face flap. The face flap is inwardly curved and extends around the periphery of the cushion to define a rear sealing surface of the cushion, The inner edge of the face flap defines an orifice through which a portion of the patient's nose passes in use.

[0024] Another aspect of the invention relates to a nasal mask defining a breathing cavity for delivering a supply of gas at a positive pressure to a patient's airway. The nasal mask has a side wall and a cushion located adjacent the side wall at a rear of the nasal mask. The rear sealing surface of the cushion has a contour at the upper lip region formed with a concave curvature to have a shape complementary to the upper lip region of the person. The contour of the rear surface of the cushion is constructed and arranged to extend from the nasal bridge region of the person to the left and right nasal corner regions of the person, respectively, in use along the left and right sides of the nose. The contour of the rear sealing surface of the cushion is further adapted to extend from the left side of the nose to the right side of the nose along the person's upper lip. The cushion further has a relatively thin face flap. The face flap is inwardly curved and extends to a periphery of the cushion to define the rear sealing surface of the cushion. An inner edge of the face flap defines an orifice through which a portion of the patient's nose passes in use. The cushion has a relatively thick back-up band formed from a resilient flexible material and extending from the sidewalls to form respective cantilevers at the upper lip region, corner regions and nasal side regions of the cushion. The length of the cantilever in the side nose region is longer than the length of the cantilever in the corner region, and the cantilever in the side nose region is constructed and arranged to provide a force in a direction approximately perpendicular to the side of the nose.

[0025] In one form, the cushion and mask body are integrally molded. Preferably, the cushion and adjacent sidewalls are integrally formed. In this configuration, a more controlled and comfortable flexing of the undercushion can be achieved.

[0026] Another aspect of the invention relates to a nasal cushion for a mask system. The nasal cushion has a sidewall defining a breathing cavity, an undercushion extending from the sidewall, and a membrane at least partially covering the undercushion. The membrane is adapted to seal along the bridge of the nose, the sides of the nose, the corners of the nose and the upper lip of a patient's face in use. The undercushion is provided only along the nasal side regions, the nasal corner regions and the upper lip regions of the cushion. The undercushion has flaps or extensions at each nasal side region that are wider than other regions of the nose and that are adapted to engage and provide force against the sides of the patient's nose in use.

[0027] Another aspect of the invention relates to a nasal cushion for a mask system, the nasal cushion having a cushion periphery that provides a plurality of regions, each region specifically configured to seal along or around the nose, each region having properties that are at least partially determinative of the sealing force, stability, force distribution, comfort and / or range of fit provided by the cushion.

[0028] Another aspect of the invention relates to a forehead support for a respiratory mask having a forehead support arm configured to extend from a frame and a forehead support pad provided on the arm, the forehead support pad having an upper headgear connector adapted to engage an upper headgear strap and a flexible region, the upper headgear connector being constructed from a first material and the flexible region being constructed from a second material that is more flexible than the first material, thereby allowing adjustment of the distance of the forehead support pad from a patient's forehead in use.

[0029] Another aspect of the invention relates to a headgear connector for a respiratory mask having a frame connection portion configured to extend from a frame and a connector provided on the frame connection portion, the frame connection portion being constructed from a more rigid material to retain the shape of the connector and transmit headgear forces to the mask, and the connector being constructed from a more flexible material to facilitate engagement and disengagement of headgear straps with the connector.

[0030] Another aspect of the invention relates to a vent for a respiratory mask having a stem, at least one branch extending from the stem, and a bend array at an end of each branch. Each vent array has a body and at least one vent hole through the body. The branches are spaced about the stem and / or angled relative to the stem to position the vent array such that it diffuses the flow of the exiting airflow.

[0031] Another aspect of the invention relates to an elbow for a respiratory mask having a mask connection end adapted to connect to a mask and a tube connection end adapted to connect to an air delivery tube. The mask connection end has a first region constructed from a more rigid material and a second region constructed from a more flexible material. The second region provides flexibility to one or more portions of the mask connection end to allow engagement and disengagement of the elbow with the mask and / or sealing of the elbow with the mask.

[0032] Further aspects of the invention are as set out in the claims.

[0033] Other aspects, features, and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which are a part of this disclosure and illustrate, by way of example, the principles of the invention.

[0034] The accompanying drawings facilitate an understanding of various examples of the present invention. [Brief description of the drawings]

[0035] [Figure 1-1] FIG. 1 is a perspective view of a nasal mask system according to an example of the present invention. [Figure 1-2] FIG. 1 is an exploded perspective view of the nasal mask system of FIG. 1-1, showing the frame, silicone cushion, elbow and swivel ring. [Figure 1-3] FIG. 2 is a perspective view showing a cushion of the nasal mask system of FIG. 1-1. [Figure 1-4] FIG. 4 is a cross-sectional view of the cushion of FIG. 1-3. [Figure 1-5] FIG. 2 is a perspective view of a cushion according to an example of the present invention. [Figure 1-6] FIG. 6 is a side view of the cushion of FIG. 1-5. [Figure 1-7] FIG. 6 is a bottom view of the cushion of FIG. 1-5. [Figure 1-8] FIG. 6 is a front view of the cushion of FIG. 1-5. [Figure 1-9] This is a cross-sectional view taken along line 1-9-1-9 in Figure 1-8. [Figure 1-10] This is a cross-sectional view taken along line 1-10-1-10 in Figure 1-8. [Figure 1-11] This is a cross-sectional view taken along line 1-11-1-11 in Figure 1-8. [Figure 1-12] This is a cross-sectional view taken along line 1-12-1-12 in Figure 1-8. [Figure 2-1] FIG. 2 is a perspective view of a nasal mask system according to another example of the present invention. [Figure 2-2] FIG. 2-2 is an exploded perspective view of the nasal mask system of FIG. 2-1 showing the frame, foam cushion, silicone cushion, elbow and swivel ring. [Figure 2-3] FIG. 2-2 is a perspective view showing a frame of the nasal mask system of FIG. 2-1. [Figure 2-4] FIG. 2-2 is a perspective view showing the foam cushion, silicone cushion, elbow and swivel ring of the nasal mask system of FIG. 2-1. [Figure 2-5] 5 is a cross-sectional view of the foam cushion, silicone cushion, elbow and swivel ring of FIG. 2-4. [Figure 2-6] FIG. 2-2 is a cross-sectional view of the silicone cushion of the nasal mask system of FIG. 2-1. [Figure 2-7] FIG. 2-2 is a cross-sectional view of the silicone cushion and foam cushion of the nasal mask system of FIG. 2-1. [Figure 2-8] FIG. 2-2 is a side view of the silicone cushion and foam cushion of the nasal mask system of FIG. 2-1. [Figure 3-1]13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-2] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-3] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Diagram 3-4] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-5] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Diagram 3-6] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-7(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-7(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Diagram 3-8] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Diagram 3-9] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-10] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-11] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-12] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-13(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-13(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(c)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(d)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(e)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(f)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(g)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-14(h)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-15] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-16(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-16(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-17] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-18] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-19] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-20(a)]13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-20(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-21] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-22] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-23] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-24] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-25(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-25(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-26(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-26(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-27] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-28] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-29] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-30] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-31(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-31(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-32] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-33] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-34] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-35] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-36(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-36(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-37] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-38] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-39] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-40] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-41] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-42] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-43] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-44(a)]13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-44(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-45] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-46(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-46(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-47] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-48(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-48(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-49(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-49(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-50(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-50(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-51] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-52(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-52(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-52(c)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-53(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-53(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-54] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-55] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-56] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-57] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-58(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-58(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-59] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-60] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-61] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-62] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-63] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-64]13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-65] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-66(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-66(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-67] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-68] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-69(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-69(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-70(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-70(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-71(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-71(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-72] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-73] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-74(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-74(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-75(a)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-75(b)] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-76] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-77] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-78] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 3-79] 13A-13C are schematic diagrams of headgear strap configurations and headgear connection configurations according to alternative embodiments of the present invention. [Figure 4-1] 1 is a schematic diagram of an elbow cushion connection configuration according to an alternative embodiment of the present invention. [Figure 4-2] 1 is a schematic diagram of an elbow cushion connection configuration according to an alternative embodiment of the present invention. [Figure 4-3] 1 is a schematic diagram of an elbow cushion connection configuration according to an alternative embodiment of the present invention. [Figure 4-4] 1 is a schematic diagram of an elbow cushion connection configuration according to an alternative embodiment of the present invention. [Figure 4-5] FIG. 13 is a schematic diagram of a swivel elbow connection configuration according to an alternative embodiment of the present invention. [Figure 4-6] FIG. 13 is a schematic diagram of a swivel elbow connection configuration according to an alternative embodiment of the present invention. [Figure 4-7] FIG. 13 is a schematic diagram of a swivel elbow connection configuration according to an alternative embodiment of the present invention. [Figure 4-8] FIG. 13 is a schematic diagram of a swivel elbow connection configuration according to an alternative embodiment of the present invention. [Figure 4-9] FIG. 13 is a schematic diagram of a swivel elbow connection configuration according to an alternative embodiment of the present invention. [Figure 5-1] FIG. 13 is an isometric view of an alternative embodiment of the present invention. [Figure 5-2] FIG. 13 is an isometric view of an alternative embodiment of the present invention. [Figure 5-3] FIG. 13 is a front view of an alternative embodiment of the present invention. [Figure 5-4] FIG. 13 is a rear view of an alternative embodiment of the present invention. [Figure 5-5] FIG. 13 illustrates an alternative embodiment of the present invention in use. [Figure 5-6] FIG. 13 is a side view of an alternative embodiment of the present invention. [Figure 6-1] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-2] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-3] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-4] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-5] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-6] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-7] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-8] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-9] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-10(a)] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-10(b)] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-11] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-12(a)] 13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 6-12(b)]13 is a schematic diagram of a headgear connection configuration according to an alternative embodiment of the present invention. [Figure 7-1] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 7-2] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 7-3] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 8-1] 13A-13D show lower headgear connectors for a frame according to an embodiment of the present invention. [Figure 8-2] 13A-13D show lower headgear connectors for a frame according to an embodiment of the present invention. [Figure 8-3] 13A-13D show lower headgear connectors for a frame according to an embodiment of the present invention. [Figure 8-4] 13A-13D show lower headgear connectors according to an alternative embodiment. [Figure 8-5] 13A-13D show lower headgear connectors according to an alternative embodiment. [Figure 9-1] 13A-13D show an elongate arm for a forehead support according to an embodiment of the present invention. [Figure 9-2] FIG. 13 illustrates a mask system with an elongated arm for forehead support according to another embodiment of the present invention. [Figure 9-3] FIG. 13 illustrates a mask system with an elongated arm for forehead support according to another embodiment of the present invention. [Figure 9-4] FIG. 13 illustrates a mask system with an elongated arm for forehead support according to another embodiment of the present invention. [Figure 10-1] FIG. 2 is a diagram of a forehead support according to an embodiment of the present invention. [Figure 10-2] FIG. 2 is a diagram of a forehead support according to an embodiment of the present invention. [Figure 10-3] FIG. 2 is a diagram of a forehead support according to an embodiment of the present invention. [Figure 10-4] FIG. 2 is a diagram of a forehead support according to an embodiment of the present invention. [Figure 10-5] FIG. 2 is a diagram of a forehead support according to an embodiment of the present invention. [Figure 10-6]FIG. 13 illustrates a forehead support according to another embodiment of the present invention. [Figure 11-1] FIG. 1 illustrates a cushion according to an embodiment of the present invention. [Figure 11-2] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 11-3] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 11-4] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 11-5] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 11-6] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 11-7] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 11-8] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 11-9] FIG. 13 is a view of a cushion according to another embodiment of the present invention. [Figure 12-1] FIG. 2 is a diagram of an elbow according to an embodiment of the present invention. [Figure 12-2] FIG. 2 is a diagram of an elbow according to an embodiment of the present invention. [Figure 12-3] FIG. 2 is a diagram of an elbow according to an embodiment of the present invention. [Figure 12-4] FIG. 13 is a diagram of an elbow according to another embodiment of the present invention. [Figure 12-5] FIG. 13 is a diagram of an elbow according to another embodiment of the present invention. [Figure 12-6] FIG. 13 is a diagram of an elbow according to another embodiment of the present invention. [Figure 12-7] FIG. 13 is a diagram of an elbow according to another embodiment of the present invention. [Figure 12-8] FIG. 13 is a diagram of an elbow according to another embodiment of the present invention. [Figure 12-9] FIG. 13 is an end view of an elbow according to an embodiment of the present invention. [Figure 13-1] FIG. 1 illustrates a swivel / vent ring according to an embodiment of the present invention. [Figure 13-2]FIG. 13 illustrates a swivel / vent ring according to another embodiment of the present invention. [Figure 14-1] FIG. 1 illustrates headgear according to an embodiment of the present invention. [Figure 14-2] FIG. 1 illustrates headgear according to an embodiment of the present invention. [Figure 15-1] FIG. 13 is a diagram of frame-cushion engagement according to an embodiment of the present invention. [Figure 15-2] FIG. 13 is a diagram of frame-cushion engagement according to an embodiment of the present invention. [Figure 15-3] FIG. 13 is a diagram of frame-cushion engagement according to an embodiment of the present invention. [Figure 16-1] FIG. 1 illustrates a mask system according to an embodiment of the present invention. [Figure 16-2] FIG. 1 illustrates a mask system according to an embodiment of the present invention. [Figure 17-1] FIG. 1 illustrates a mask system according to an embodiment of the present invention. [Figure 17-2] FIG. 1 illustrates a mask system according to an embodiment of the present invention. [Figure 18-1] FIG. 2 illustrates headgear routing according to an embodiment of the present invention. [Figure 18-2] FIG. 2 illustrates the routing of headgear according to an embodiment of the present invention. [Figure 19-1] FIG. 2 illustrates the routing of headgear according to an embodiment of the present invention. [Figure 19-2] FIG. 2 illustrates the routing of headgear according to an embodiment of the present invention. [Figure 20-1(a)] 1 is a series of plan views of a bendable or flexible forehead support according to an embodiment of the present invention. [Figure 20-1(b)] 1 is a series of plan views of a bendable or flexible forehead support according to an embodiment of the present invention. [Figure 20-1(c)] 1 is a series of plan views of a bendable or flexible forehead support according to an embodiment of the present invention. [Figure 20-2(a)]1 is a series of perspective views of a bendable or flexible forehead support according to an embodiment of the present invention. [Figure 20-2(b)] 1 is a series of perspective views of a bendable or flexible forehead support according to an embodiment of the present invention. [Figure 20-2(c)] 1 is a series of perspective views of a bendable or flexible forehead support according to an embodiment of the present invention. [Figure 21(a)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 21(b)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 21(c)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 21(d)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 21(e)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 21(f)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 21(g)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(a)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(b)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(c)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(d)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(e)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(f)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(g)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 22(h)]1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 23(a)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 23(b)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 23(c)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 23(d)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 23(e)] 1A-1C are diagrams of a forehead support including a flexible area according to an embodiment of the present invention. [Figure 24(a)] FIG. 13 illustrates a forehead support with each side of the crossbar having a resilient spring arm according to an embodiment of the present invention. [Figure 24(b)] FIG. 13 illustrates a forehead support with each side of the crossbar having a resilient spring arm according to an embodiment of the present invention. [Diagram 25] FIG. 1 illustrates a forehead support including a forehead pad made of a soft foam material according to an embodiment of the present invention. [Figure 26] FIG. 1 illustrates a forehead support including a forehead pad made of a soft foam material according to an embodiment of the present invention. [Figure 27] FIG. 2 is a diagram of a frame for a mask system according to an embodiment of the present invention. [Figure 28] FIG. 2 is a diagram of a frame for a mask system according to an embodiment of the present invention. [Figure 29] FIG. 2 is a diagram of a frame for a mask system according to an embodiment of the present invention. [Diagram 30] FIG. 2 is a diagram of a frame for a mask system according to an embodiment of the present invention. [Diagram 31] FIG. 2 is a diagram of a frame for a mask system according to an embodiment of the present invention. [Diagram 32] FIG. 2 is a diagram of a frame for a mask system according to an embodiment of the present invention. [Diagram 33] FIG. 2 is a diagram of a cushion for a mask system according to an embodiment of the present invention. [Diagram 34] FIG. 2 is a diagram of a cushion for a mask system according to an embodiment of the present invention. [Diagram 35] FIG. 2 is a diagram of a cushion for a mask system according to an embodiment of the present invention. [Diagram 36] FIG. 2 is a diagram of a cushion for a mask system according to an embodiment of the present invention. [Figure 37] FIG. 2 is a diagram of a cushion for a mask system according to an embodiment of the present invention. [Figure 38] FIG. 2 is a diagram of a cushion for a mask system according to an embodiment of the present invention. [Figure 39] FIG. 2 is a diagram of a cushion for a mask system according to an embodiment of the present invention. [Diagram 40] 33-39 and the frame of FIGS. 27-32 assembled together according to an embodiment of the present invention. FIG. [Diagram 41] 33-39 and the frame of FIGS. 27-32 assembled together according to an embodiment of the present invention. FIG. [Diagram 42] 33-39 and the frame of FIGS. 27-32 assembled together according to an embodiment of the present invention. FIG. [Diagram 43] 33-39 and the frame of FIGS. 27-32 assembled together according to an embodiment of the present invention. FIG. [Diagram 44] 33-39 and the frame of FIGS. 27-32 assembled together according to an embodiment of the present invention. FIG. [Diagram 45] 33-39 and the frame of FIGS. 27-32 assembled together according to an embodiment of the present invention. FIG. [Figure 46] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 47] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 48]FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 49] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 50] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 51] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 52] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 53] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 54] FIG. 1 illustrates an elbow and swivel for a mask system according to an embodiment of the present invention. [Figure 55] FIG. 13 is a plan view of a vent assembly according to another embodiment of the present invention. [Figure 56] 56 is a cross-sectional view taken along line 56-56 in FIG. 55. [Figure 57] FIG. 56 is a side view of the vent assembly shown in FIG. [Figure 58] FIG. 56 is a diagram of a mask cushion provided with the vent assembly of FIG. 55 according to an embodiment of the present invention. [Figure 59] 59 is a cross-sectional view taken along line 59-59 in FIG. 58. [Figure 60] FIG. 13 shows an elbow with a vent according to another embodiment of the present invention. [Figure 61] FIG. 13 shows an elbow with a vent according to another embodiment of the present invention. [Figure 62] FIG. 13 shows a cushion with a vent according to another embodiment of the present invention. [Figure 63] FIG. 13 shows a cushion with a vent according to another embodiment of the present invention. [Figure 64] FIG. 60 is an alternative view of the vent assembly of FIGS. 55-59. [Figure 65]FIG. 60 is an alternative view of the vent assembly of FIGS. 55-59. [Figure 66] 11A-11C are alternative views of a forehead support arm and forehead support pad according to an embodiment of the present invention. [Figure 67] 11A-11C are alternative views of a forehead support arm and forehead support pad according to an embodiment of the present invention. [Figure 68] 11A-11C are alternative views of a forehead support arm and forehead support pad according to an embodiment of the present invention. [Figure 69] 11A-11C are alternative views of a forehead support arm and forehead support pad according to an embodiment of the present invention. [Figure 70] 11 is an alternative view of a lower headgear connector according to an embodiment of the present invention. [Figure 71] FIG. 2 is a front perspective view of a cushion according to an embodiment of the present invention. [Figure 72] FIG. 72 is a rear perspective view of the cushion of FIG. 71. [Figure 73] FIG. 72 is a front view of the cushion of FIG. 71. [Figure 74] FIG. 72 is a rear view of the cushion of FIG. 71. [Figure 75] FIG. 72 is a plan view of the cushion of FIG. 71. [Figure 76] FIG. 72 is a bottom view of the cushion of FIG. 71. [Figure 77] FIG. 72 is a side view of the cushion of FIG. 71. [Figure 78] FIG. 72 is a front view of the cushion of FIG. 71 showing the cutting lines. [Figure 79] 79 is a cross-sectional view taken along line 79-79 in FIG. 78. [Figure 80] 79 is a cross-sectional view taken along line 80-80 in FIG. 78. [Figure 81] 71 is a cross-sectional view taken along line 81-81 in FIG. 78. [Figure 82] 72 is a cross-sectional view taken along line 82-82 of FIG. 78. [Figure 83] FIG. 72 is an enlarged cross-sectional view of the undercushion flap in the nasal side region of the cushion of FIG. 71. [Figure 84] FIG. 72 is a schematic diagram showing localized thickening of the undercushion of the cushion of FIG. 71. [Figure 85] FIG. 72 is an enlarged cross-sectional view of the undercushion at a corner of the nasal region of the cushion of FIG. 71. [Figure 86] 1 is a schematic diagram illustrating the sealing force of a cushion viewed from the side of a patient's nose in accordance with an embodiment of the present invention. [Figure 87] 1 is a schematic diagram illustrating the sealing force of a cushion viewed in front of a patient's nose in accordance with an embodiment of the present invention. [Figure 87-1(a)] A cross-sectional view taken along line 87-1-87-1 in Figure 87 showing a modification of the undercushion for a lower nasal bridge. [Fig. 87-1(b)] A cross-sectional view taken along line 87-1-87-1 in Figure 87 showing a modification of the undercushion for a high nasal bridge. [Figure 87-2] FIG. 2 is a schematic diagram showing the sealing force of the cushion as viewed from above the patient's nose in accordance with an embodiment of the present invention, with the cushion membrane rolled up for illustrative purposes to reveal the position of the undercushion in use. [Figure 88] FIG. 2 is a diagram of a frame according to an embodiment of the present invention. [Figure 89] FIG. 2 is a diagram of a frame according to an embodiment of the present invention. [Figure 90] FIG. 2 is a diagram of a frame according to an embodiment of the present invention. [Figure 91] FIG. 2 is a diagram of a frame according to an embodiment of the present invention. [Figure 92] FIG. 2 is a diagram of a frame according to an embodiment of the present invention. [Figure 93] FIG. 2 is a diagram of a frame according to an embodiment of the present invention. [Figure 94] FIG. 2 is a front view of a frame and cushion showing a cutting line according to an embodiment of the present invention. [Figure 95] 95 is a cross-sectional view taken along line 95-95 in FIG. 94. [Figure 96] 96 is a cross-sectional view taken along line 96-96 in FIG. 94. [Figure 97] 97 is a cross-sectional view taken along line 97-97 in FIG. 94. [Figure 98] 98 is a cross-sectional view taken along line 98-98 in FIG. 94. [Figure 99] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 100] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 101] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 102] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 103] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 104] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 105] FIG. 1 is a diagram of a mask system according to an embodiment of the present invention. [Figure 106] 99-105 with the headgear on the patient's face in use according to an embodiment of the present invention. [Figure 107] 99-105 with the headgear on the patient's face in use according to an embodiment of the present invention. [Figure 108] FIG. 2 is an assembly view of an elbow according to an embodiment of the present invention. [Figure 109] FIG. 109 is a cross-sectional view of the elbow of FIG. 108. [Figure 110] FIG. 109 is a side view of the elbow of FIG. [Figure 111] 111 is a cross-sectional view taken along line 111-111 in FIG. [Figure 112] 112 is a cross-sectional view taken along line 112-112 in FIG. [Figure 113] FIG. 2 is a side view of an elbow according to an embodiment of the present invention. [Fig. 114] 114 is a cross-sectional view taken along line 114-114 in FIG. 113. [Figure 115] 115 is a cross-sectional view taken along line 115-115 in FIG. 113. [Figure 116-1] 13A-13D illustrate sealing of the cushion in the nasal bridge area according to an embodiment of the present invention. [Figure 116-2] 13A-13D illustrate sealing of the cushion in the nasal bridge area according to an embodiment of the present invention. [Figure 116-3] 13A-13D illustrate sealing of the cushion in the nasal bridge area according to an embodiment of the present invention. [Figure 117] 13A-13D show flex points or areas of an undercushion according to various aspects of the present technology. [Fig. 118] 13A-13D show flex points or areas of an undercushion according to various aspects of the present technology. [Figure 119] FIG. 1 illustrates a flex point or area of ​​an undercushion according to one of the various aspects of the present technology, and shows a cross-section of an undercushion or back-up band suitable for use along the side of the nose, which can provide a sealing force to the plane of the face (arrow pointing up) and to the side of the nose (arrow pointing left). [Figure 120] 13A-13D show flex points or areas of an undercushion according to various aspects of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] The following description is provided in relation to several examples that may share common characteristics and features. It should be understood that one or more features of any example may be combinable with one or more features of other examples. Furthermore, any one feature or combination of features in any of the examples may constitute additional examples.

[0037] In this specification, the word "comprising" should be understood in an open-ended sense, i.e., in the sense of "including," and therefore should not be limited to a restrictive sense, i.e., to the sense of "consisting only of." Where the corresponding words "comprise", "comprised" and "comprises" appear, these words have the corresponding meanings.

[0038] The term "air" should be interpreted to include breathable gases, for example air supplemented with oxygen.

[0039] 1. Nasal mask system Examples of the present invention are directed to nasal mask systems that are easy and quick to fit (e.g., with little or no adjustment), can reduce strap tension, are producible in high volume, have high consumer appeal, provide comfort and a seal, offer reliable quality, are unobtrusive, and / or fit the majority of people.

[0040] As will be described in more detail below, the nasal mask system includes a frame, a sealing mechanism (e.g., a cushion) mounted on the frame and adapted to form a seal with the patient's nose, and an elbow, e.g., mounted on the sealing mechanism and adapted to be connected to an air delivery tube that delivers breathable gas to the patient. A swivel ring can be optionally provided to couple the elbow to the sealing mechanism. Headgear can be removably attached to the frame to maintain the nasal mask system in a desired adjusted position on the patient's face. The nasal mask system is intended for use in positive pressure therapy for users with obstructive sleep apnea (OSA) or another breathing disorder.

[0041] Although the following examples are described as including a nasal interface style, aspects of the invention can be adapted for use with other suitable interface styles, such as full face interfaces, nasal prongs, and the like.

[0042] 2. Frame As shown in Figures 1-1, 1-2 and 2-1-2-3, the frame 20 (also referred to as an exoskeleton or skeleton) is configured to hold, stabilize and / or support the sealing mechanism 40 (and elbow 70) in an operative position against the patient's face. Additionally, the frame 20 is configured to attach headgear to a nasal mask system.

[0043] As shown, the body 22 of the frame 20 (see, e.g., Figures 1-2, 2-2 and 2-3) has an open structure with a central opening 24 that allows the sealing mechanism 40 to communicate with or receive the elbow 70 and a sidewall 26 configured to retain or otherwise engage the sealing mechanism 40. In use, the frame 20 in this example is not in an airway, i.e., the sealing mechanism 40 defines a breathing cavity and is directly coupled to the elbow 70, as described below. The frame 20 The frame 20 may be semi-rigid or may allow for at least some flexibility. The frame 20 may be made from a single material, a combination of materials, or a combination of the same material with different hardnesses. The frame 20 may be made from polycarbonate, polypropylene, nylon, clear nylon, thermoplastic elastomers (TPE), silicone, or any other suitable material.

[0044] The forehead support 30 extends from the upper end of the body 22. The forehead support 30 may be fixed (i.e., not adjustable), adjustable (e.g., the height or length of the elongated arm may be extendable or the angle of the forehead support may be changeable), or replaceable (e.g., different sizes of forehead support for different size patients, or the elongated arm may be replaced with a variety of arms of different lengths). The forehead support 30 has an elongated arm 32 and an upper headgear connector 34, which provides slots or receiving holes 35 at the free ends of the arms adapted to receive respective headgear straps in use, thus utilizing the padding of the headgear straps rather than requiring separate pads. In one example, the headgear connector may be adjustable relative to the arm 32, for example (e.g., may be tilted or angled toward the patient's forehead). A lower headgear connector 36 is provided for each side of the body 22, each having an elongated arm 38 and a slot or receiving hole 39 at the free end of the arm adapted to receive a respective headgear strap in use. The elongated arms 38 may be bendable or selectively deformable such that the arms can be bent in use toward or away from the patient's face, thereby allowing the headgear to be pulled over the patient's face, for example, for side sleeping. In one example, if the elongated arms 38 are bendable or deformable under pressure from the user's hands, they may be suitably malleable to retain the deformed shape. This feature of the elongated arms 38 may improve the comfort, fit and / or seal of the embodiment. The forehead support and headgear connectors may provide an unobtrusive arrangement extending out of the patient's line of sight. The generally thin and elongated structure of the elongated arms 38 may at least partially prevent or limit obstruction to the patient's line of sight while wearing the embodiment. In one example, the elongate arm 38 may be constructed from a wire or a metal alloy.However, one skilled in the art will appreciate that other materials may be used, including, but not limited to, polymeric materials.

[0045] In one example, the arms 32, 38 can be suitably shaped, molded, or contoured to follow the contours of the patient's face while avoiding the patient's line of sight or obstructing the patient's vision. The arms 32, 38 can also have some inherent flexibility to allow for a range of adjustment. The elongated arms 32, 38 can be made from a generally non-stretchable material, such as aluminum, stainless steel, polycarbonate, polypropylene, TPE, or any other suitable material. Alternatively, the elongated arms 32, 28 can be continuous with the frame 20 and therefore made from the same material, or made from the same material as the frame 20 but not of unitary construction (i.e., the elongated arms 32, 38 can be attached to the frame 20). However, if the elongated arms 32, 38 are made from a different material than the frame 20, the elongated arms 32, 38 can be secured to the frame 20 using another attachment or fastening method, such as, for example, adhesive. The upper headgear connector 34 can be made from the same material as the elongated arms 32. Alternatively, the upper headgear connectors 34 may be made from a more flexible material than the elongated arms 32, such as Hytrel™, silicone, nylon, or any other suitable material. The lower headgear connectors 36 may be continuous with the frame 20 and therefore made from the same material, or may be made from the same material as the frame 20 but not be of unitary construction (i.e., the elongated arms 38 may be attached to the frame 20). Alternatively, the lower headgear connectors 36 may be made from a more flexible material than the frame 20, such as Hytrel™, silicone, nylon, or any other suitable material.

[0046] The forehead support and headgear connectors may be integrally molded with or otherwise attached to the body of the frame 20. The frame 20 is constructed from a more rigid material than the sealing mechanism 40 (e.g., silicone, foam). For example, the frame may be constructed from a plastic (e.g., polycarbonate) and / or metal material, such as a relatively thin metal material.

[0047] In one example, the arms 32 and / or 38 may be relatively thin or elongated (e.g., 1 mm to 3 mm). In one example, the forehead support 30 and the headgear connector 36 may be formed from a material (e.g., a metal material) different from the material of the frame body 22. In such an example, the forehead support 30 and the headgear connector 36 may be attachable to the frame body 22. Relatively thin or elongated arms 32 and / or 38 may reduce the overall visual impact of the mask or embodiment.

[0048] In one example, the upper headgear connector 34 provides a flat area for attachment of straps from the headgear. In one example, the straps are attached to the upper headgear connector 34 through two openings 35 attached to either side of the upper headgear connector 34, and in this embodiment the straps are adapted to extend through the openings and exert a force towards the patient's face, effectively pulling the upper headgear connector 34 towards the patient's forehead.

[0049] 2.1 Alternative frames 5-1 through 5-6 illustrate an alternative embodiment of a frame 420 configured to maintain or otherwise support the sealing mechanism 440 (and elbow 70) in an operative position against the patient's face.

[0050] The frame 420 can be configured to attach the headgear to a nasal mask system. The frame 420 can be made of polycarbonate, polypropylene, nylon, or any other suitable material. A swivel ring 90 can connect the sealing mechanism 440 to the elbow 70. The swivel ring 90 can be any suitable polymer, such as polycarbonate or polypropylene. The elbow 70 can be small and unobtrusive. The elbow can have a vent mechanism 75 with holes or openings for ventilation. The elbow 70 can be made of polypropylene, polycarbonate, or any other suitable material.

[0051] The forehead support 430 extends from the upper end of the body 422 of the frame 420. The forehead support 430 may be fixed (i.e., not adjustable), adjustable (e.g., the height or length of the elongated arm may be extendable or the angle of the forehead support may be changeable), or replaceable (e.g., different sizes of forehead supports for different sizes of patients, or the elongated arm may be replaced with a variety of arms of different lengths). The forehead support 430 has an elongated arm 432 and an upper headgear connector 434, which provides slots or receiving holes 435 at the free ends of the arms 432 adapted to receive respective headgear straps in use, thus utilizing the padding of the headgear straps rather than requiring separate pads. In one example, the headgear connector 434 may be adjustable relative to the arms 432, for example (e.g., may be tilted or angled toward the patient's forehead).

[0052] The upper headgear connector, i.e., forehead support pad 434, can be made from silicone, nylon, polypropylene, TPE, polycarbonate, or any other suitable material. The elongated arms 432 can be made from a malleable metal. The frame 420 can be the connection point for the elongated arms 432 and the sealing mechanism 440.

[0053] On each side of the body 422 of the frame 420, a lower headgear connector 436 is provided. The lower headgear connectors 436 may be hook-shaped. The lower headgear connectors 436 may be integrally formed with the body 422 of the frame 420 or may be formed separately from the body and attached, for example, by adhesive or any form of mechanical fastening.

[0054] Each lower headgear connector 436 may have a gap 439 between an upper end of the connector 436 and the body 422 of the frame to allow a headgear strap to be inserted therebetween. It should be understood that the headgear connectors 436 may be connected to the body 422 of the frame 420 at both the lower and upper ends. The connector 436 may be bendable or selectively deformable such that in use the connector 436 can bend toward or away from the patient's face, thereby allowing the headgear to be pulled over the patient's face, for example, while sleeping on one side. This may improve the comfort, fit and / or seal of the nasal mask system. The forehead support 430 and headgear connectors 434, 436 may provide an unobtrusive arrangement that extends out of the patient's line of sight. The lower headgear connector 436 may be located at a lower corner position of the body 422 of the frame 420 to at least partially prevent or limit obstruction to the patient's line of sight while wearing the nasal mask system.

[0055] 2.2 Alternative frames The following show alternative embodiments of the frame, arms and forehead support for the mask system.

[0056] 2.2.1 Frame 7-1-7-3 show a nasal mask system including a frame 520, a sealing mechanism or cushion 540, an elongated arm 532 and forehead support 530, an elbow 570, and a ring 590 that connects the elbow to the cushion.

[0057] As best shown in FIGS. 8-1-8-3, each lower headgear connector 536 on the frame may be generally S-shaped. Each lower headgear connector has an upper portion 536(1), a middle portion 536(2), a lower portion 536(3), and a connecting portion 536(4) that attaches the connector to the frame. The upper portion 536(1) may have a lead-in adapted to guide the headgear straps in place. The middle portion 536(2) is adapted to abut or be adjacent to the frame to retain the engaged straps within the connector. The lower portion 536(3) is adapted to receive a strap tucked through the middle portion. The connecting portion 536(4) allows the connector to hinge outwardly, i.e., away from the frame, thereby allowing the headgear straps to pass between the middle portion of the connector and the frame.

[0058] The connector 536 is closely aligned to the frame to allow ease of use when sliding the headgear along the side of the frame. The self-closing connector allows easy access while still acting as a retention feature for the headgear.

[0059] In one embodiment, one or more portions of the connector may be constructed from TPE.

[0060] 8-4 and 8-5 show alternative lower headgear connectors, such as a hook-like connector 536-1 and a connector 536-2 whose free end is adapted to engage with a connector base 520-1 of the frame. As shown in FIG. 8-5, the free end of the hook-like connector 536-1 has a retention hook that helps to retain the headgear straps. As shown in FIG. 8-4, the connector 536-2 can be biased into engagement with the base 520-1 to help retain the headgear straps.

[0061] 16-1 and 16-2 show another embodiment of a frame 520-1 supporting a cushion and headgear (e.g., an open frame configuration with a lower crossbar 5536 for a lower headgear strap and a forehead support bar with openings 5537 for an upper headgear strap). FIG. 17-1 and 17-2 show another embodiment of a frame 520-2 supporting a cushion and headgear (e.g., a headgear clip 5540 having openings 5440(1) adapted to engage with a bar-like receptacle 5541 on the frame). The frame 520-2 also has a forehead support bar with openings for an upper headgear strap similar to FIG. 16-1 and 16-2 described above. Additionally, the frame 520-2 has an upwardly extending cushion support bar 521 adapted to support and / or hold a cushion.

[0062] In an alternative embodiment, the frame may have clip receptacles adapted to releasably mate with respective headgear clips associated with the lower headgear straps.

[0063] 2.2.2 Thin arm The frame supports an elongated arm (eg, constructed from metal, malleable metal) that holds a forehead support.

[0064] In one embodiment, the metal arm 532 can be a sealed extrusion, as shown in Figures 7-1-7-3. As shown in Figure 9-1, the metal m of the arm 532 can be wider at the front so that the plastic seal p does not cover the metal. Such a seal configuration provides a soft feel feature that both softens and protects the metal.

[0065] In another embodiment, the metal arms may be exposed extrusions (e.g., polished extruded aluminum) as shown in Figures 9-2 and 9-3. This configuration accentuates the metal features and provides a streamlined, unobtrusive design.

[0066] FIG. 9-4 shows an arm 532 constructed from glass-filled nylon encapsulated in a polymer coating (silicone, TPE, etc.). An encapsulated metal design can be used instead of reinforced plastic to provide strength instead of metal and facilitate a thin, unobtrusive arm. This construction also provides the opportunity to add color and finish details.

[0067] 2.2.3 Forehead support The forehead support is supported by arms 532. As shown in FIGS. 10-1-10-5, the forehead support 530 can incorporate a flexible region 531 that allows the forehead support 530 to flex from its natural v-shaped position or shape to a more straight position or shape. The flexible region can be a thinned section of material (i.e., the same material as the rest of the forehead support, simply thinned to allow for flexing) when compared to the rest of the forehead support 530, a softer, less rigid material, or a combination of a softer material and a thin section.

[0068] The flexible region may be a co-molded portion of a flexible material such as a thermoplastic elastomer (which may be colored), silicone, or any other material that can be flexed. The remaining portion of the forehead support may be made from a less flexible material such as nylon, polycarbonate, or polypropylene. Co-molding may be via a chemical and / or mechanical bond between the two materials. A separately formed / assembled flexible region reduces the risk of breakage and allows for off-site assembly with the headgear. The forehead support may have a matte finish.

[0069] In one embodiment, the forehead support 530 may first be molded flat. The flexible region 531 may then be molded onto the forehead support 530 to place the forehead support 530 in its in-use or flexed configuration. This may provide a preload or bias or spring to the forehead support.

[0070] The flexible region provides an auto-adjusting flex function that is adjusted by the tension of the headgear allowing a greater bias of the cushion to aid in fit. Preferably, the forehead support can flex to tilt or rotate the upper portion of the mask cushion inward and outward toward the patient's nasal bridge region. In one form, when the headgear straps are tightened, the forehead support can splay outward or flatten against the patient's forehead. This tilts or rotates the mask cushion, with the lower portion of the mask cushion acting as a hinge point. This allows the upper portion of the mask cushion to tilt or rotate inward toward the patient's nasal bridge in a direction generally perpendicular to the plane of the patient's face. This can be useful for patients with higher nasal bridges than other patients, as this biases the nasal bridge region of the mask cushion into sealing engagement with the patient's nose.

[0071] Alternatively, the forehead support can be made from a thickened flexible material, such as foam, that can be compressed to achieve a similar result.

[0072] As shown in FIG. 10-2, the position of the forehead support without any load (ie, in a natural state) can be specified as an angle α, which can be, for example, 5° to 90°, for example, 15°.

[0073] In use, the forehead support can allow for adjustment in the anterior-posterior direction (as shown by the arrows in Figs. 10-2 and 10-4) of about 0 mm to 30 mm. In an exemplary embodiment, the forehead support can allow for adjustment in the anterior-posterior direction of about 5 mm to 20 mm (e.g., about 10 mm to 20 mm, about 10 mm to 15 mm). This can allow for a wider range of patient compatibility by accommodating a greater variety of anthropometrics, particularly in the nasal bridge region.

[0074] The headgear can be attached to the forehead support through loop holes 535 (see, e.g., Figures 10-1 and 10-3) or via a loop-through arrangement in which slots 535-1 extend into holes 535 (see Figure 10-6).

[0075] 2.3 Alternative embodiments of the forehead support 20-1(a)-26 show alternative embodiments of the forehead support.

[0076] One of the advantages of the forehead support is that it provides a reasonable amount of adjustment without a large number of additional components. In a preferred example, the forehead support is molded all in one piece. Additionally, by pulling the headgear straps in the forehead area toward the back of the patient's head, the cushion intuitively moves and rotates toward the bridge of the nose, potentially reducing and eliminating leakage in that area.

[0077] In accordance with an example of the present technology, there is provided a mask system having a nasal cushion and a frame. The frame has a forehead support having a T-bar. The T-bar has a main axis and a cross bar. In one form, the cross bar has a left side and a right side.

[0078] A mask system according to aspects of the present technology includes headgear, in one form the headgear includes left and right forehead straps that are constructed and arranged to engage, in use, the left and right sides of a crossbar at apex-to-distal locations.

[0079] In one form, the left and right sides are disposed at an angle of less than about 180° to each other. In this form, the crossbar may be V-shaped in plan view. An apex is defined between the left and right sides. In one form, the left and right sides are constructed and arranged to bend or flex about the apex. In one form, bending or flexing the sides by pulling on their ends increases the angle between them, moving the contact point between the crossbar and the main axis closer to the forehead and rotating the cushion.

[0080] In an alternative configuration, the left and right sides of the crossbar may be U-shaped, in which case the crossbar may function similarly to the V-shaped configuration described above.

[0081] For example, FIGS. 20-1(a)-20-1(c) and 20-2(a)-20-2(c) each show sequential views of a generally U-shaped crossbar 1034 configured to bend or flex about an apex as headgear tension from headgear straps 1080 is applied to each side of the crossbar. As shown, the forehead support begins in an extended position in front of the patient's forehead. As the patient tightens the headgear (i.e., the headgear straps are pulled outward from the crossbar as shown by the arrows), the sides of the crossbar open up or flex outward and the crossbar moves to a substantially flat position on the patient's forehead, which can bias the cushion inward toward the patient's face. By positioning the slots 1035 for each headgear strap in the crossbar relatively far outward from the apex (e.g., distance d as shown in FIG. 20-2(c)), the vector can be increased (e.g., reducing the force required to pull the forehead support toward the patient's head with effective force).

[0082] Bending or flexing can be achieved by molding the crossbars from a material that is thinner in the middle. Thus, the crossbar can be more flexible in the middle than at either end. Additionally or alternatively, the crossbars can be formed by co-molding a stiffer material (such as nylon) with a more flexible material (such as a thermoplastic elastomer).

[0083] For example, as shown in FIGS. 20-1(a)-20-1(c) and 20-2(a)-20-2(c), the crossbar can have a middle portion 1034(1) constructed from a more flexible material (e.g., flexible TPE or silicone) and end or side portions 1034(2) constructed from a more rigid material (e.g., clear nylon).

[0084] 21(a)-23(e) show alternative configurations of the forehead support and its crossbar. For example, FIGS. 21(a)-21(G) show a forehead support in which a flexible region 1036 is disposed between the more rigid regions, i.e., the middle portion 1034(1) and each side portion 1034(2) of the crossbar. The flexible region 1036 is constructed from a more flexible material (e.g., Hytrel®), while the middle portion 1034(1) and the side portions 1034(2) are constructed from a more rigid material (e.g., nylon). As shown, the flexible region can be embedded in the more rigid region. Also, the flexible region can be interlocked with the more rigid region by a retaining feature, e.g., a dovetail interlock. Figures 22(a)-22(h) and 23(a)-23(e) show alternative configurations in which the flexible region 1036 interlocks or couples with the stiffer regions 1034(1), 1034(2). In Figures 23(a)-23(e), the flexible region incorporates the sides of the crossbar.

[0085] The forehead support and headgear are constructed and arranged such that pulling on the left and / or right forehead straps moves the primary axis to rotate the cushion. In this manner, the fit of the mask can be adjusted for different face shapes. For example, pulling on the straps can rotate the cushion towards the face to reduce leakage in the nasal bridge area.

[0086] 24(a) and 24(b) show a forehead support with a resilient spring arm 1037 on each side of a crossbar. As shown, a headgear strap 1080 is adapted to form a loop around the spring arm such that the headgear strap engages the patient's forehead with the spring arm disposed between the crossbar and the headgear strap. In use, tension in the headgear can cause the spring arm to bend or flex, moving the contact point of the forehead support closer to the patient's forehead.

[0087] 25 and 26 show a forehead support having a forehead pad 1090 constructed from a flexible material such as foam or gel. As shown in FIG. 25, the forehead pad can be coupled to the crossbar 1034 by a snap fit, for example the forehead pad 1090 has snap fingers 1091 adapted to engage with respective openings 1038 in the crossbar by a snap fit. Both sides of the crossbar have open ended slots adapted to engage with headgear straps. As shown in FIG. 26, headgear straps 1080 can cross the crossbar 1034 and its forehead pad 109, thereby engaging the patient's forehead with the forehead pad disposed between the crossbar and the headgear straps.

[0088] 2.4 Further Alternative Frame Embodiments A frame may be provided in the system to stabilize the cushion in place and to anchor the headgear to hold the cushion in place. The frame may provide additional structure or support to the cushion.

[0089] The alternative frame 2020 shown in FIGS. 27-32 includes a body 2100, a forehead support arm 2400 and a forehead support pad 2530. As shown in FIG.

[0090] The body 2100 can be configured to capture or engage the cushion and lower headgear straps. An upper region 2700 engages with a top or apex region of the mask cushion. The upper region 2700 can be located at the upper or top portion of the body 2100 on the non-patient side of the mask frame 2020. The upper region 2700 can also provide stability to the front or elbow engagement portion of the cushion by adding stiffness or support to this region of the cushion. A lower region 2800 can be located generally below the upper region. The lower region 2800 can engage or otherwise interface with a bottom region of the mask cushion.

[0091] The rear connector or engagement portion 2650 (see FIGS. 29 and 32) can be configured to receive a tab or locking element of the mask cushion. The rear engagement portion 2650 can also aid in locating the mask cushion within the mask frame 2020. The rear engagement portion 2650 can be a cutout or opening. The rear connector 2650 can be located on the patient side of the frame 2020.

[0092] The lower headgear connectors 2520 can be positioned to receive loops of headgear. The lower headgear connectors 2520 may be generally hook-like or C-shaped to receive headgear straps and keep them in place. The lower headgear connectors 2520 can be attached to or otherwise formed with the body 2100 by connections 2525. The connections 2525 can allow some flexibility or hinge movement to allow some freedom of movement of the lower headgear connectors 2520.

[0093] The lower headgear connector 2520 may be formed from a flexible material, including, for example, but not limited to, silicone, TPE, or any other suitable material. The lower headgear connector may be formed from a combination of materials, such as a more rigid material to retain shape and transfer headgear forces to the mask, and a more flexible material to allow easy engagement and disengagement of the headgear straps. This may include a combination of materials such as nylon and silicone. The flexible material may also have adhesion or friction to the material so that the headgear does not slide within the connector. This may include, but is not limited to, silicone. Preferably, assembly of the headgear to the lower headgear connector requires less force than disassembly of the headgear from the lower headgear connector. Preferably, the disassembly force is less than 15 N. More preferably, the disassembly force is less than 10 N.

[0094] FIG. 70 shows an alternative view of the lower headgear connector 2520. As shown, a generally hook-like or C-shaped lower headgear connector 2520 (constructed from a more flexible material, e.g., silicone) is overmolded or co-molded with a body connecting portion 2525 of the body 2100 (constructed from a more rigid material, e.g., nylon). Preferably, the flexible material can be silicone. Preferably, the flexible material can have a Shore A durometer of about 20-80. Most preferably, the flexible material can have a Shore A durometer of about 40-60. Most preferably, the flexible material can have a Shore A durometer of about 60. The connecting portion 2525 has a connecting portion 2526 that aids in molding the connector 2520 to the connecting portion 2525. The connecting portion 2526 has a retention slot 2526(1) that aids in mating or mechanical locking with the more rigid connecting portion 2525 of the overmolded flexible connector 2520. The connecting portion 2526 also extends substantially to the height or top of the connector 2520 to strengthen the headgear connection at the connector, i.e., the more rigid material of the connecting portion retains the shape of the connector so that the headgear does not slip off the connector and transfers headgear forces to the mask. The flexible connector 2520 also allows for easier removal of the straps from the connector and easier connection of the straps to the connector, for example, a connector that is deformable to facilitate removal and connection of the straps.

[0095] As shown in FIG. 89, the lower headgear connectors can provide inner surfaces 2521(1), 2521(2) that are angled at an angle α1 relative to each other to aid in retention of the headgear straps and prevent inadvertent removal. Preferably, α1 can be less than 180°. Preferably, α1 can be about 110°-160°. Most preferably, α1 can be about 120°-150°. Also, the spacing of the connectors from the body of the frame also aids in retention of the straps. Preferably, the spacing of the connectors from the body can vary along the length of the connector. Preferably, the widest gap between the connectors and the body can be less than 15 mm to aid in retention of the straps. More preferably, the widest gap between the connectors and the body can be less than 10 mm to aid in retention of the straps.

[0096] As shown in Figs. 41-44, side engagement tabs 2600 can be located on the lateral flanges of the main portion 2100 and the patient side of the mask frame to interface with and support the mask cushion. In one embodiment, the tabs are located adjacent to where the undercushion terminates at the nasal bridge region. The tabs can form an interference fit with a portion of the cushion. The tabs can be thinner than the remainder or surrounding portions of the frame. The tabs can also support the cushion so that it is supported in sealing engagement with the side of the patient's nose or cheek regions. The tabs 2600 provide structural support to the flexible cushion so that it does not collapse (e.g., burst) away from the patient's face and thus potentially break the seal during use. The tabs 2600 can extend rearward from the arms 2400 as shown in Fig. 43.

[0097] The forehead support arm 2400 extends from the main body 2100 to the forehead pad 2530. Preferably, the forehead support arm 2400 is thin (e.g., 1 mm to 5 mm, less than 10 mm, or about 1 mm to 5 mm) so as not to interfere with the patient's vision, and is structurally stable or relatively non-stretchable so as to support the mask in place.

[0098] The forehead support pad 2530 may have an upper headgear connector 2535 that engages with the upper headgear strap. The forehead support pad may further have a flexible region 2540 for adjusting the distance of the forehead support pad from the patient's forehead in use. By tightening or adjusting the upper headgear strap in the normal tension range without causing discomfort, the flexible region 2540 may flatten to pull the forehead support pad closer to the patient's forehead. This then causes the body to tilt inwardly towards the patient's nasal bridge, thereby pressing the mask cushion further onto the patient's nasal bridge in use. In one embodiment, the force to flatten the flexible region may be in the range of about 1N to 8N. Preferably, the force to flatten the flexible region may be in the range of about 2N to 6N. Most preferably, the force to flatten the flexible region may be in the range of about 2N to 4N.

[0099] 66-69 show alternative views of the forehead support arm 2400 and forehead support pad 2530. As shown, the forehead support pad 2530 has an upper headgear connector 2535 (e.g., constructed from a more rigid material, such as nylon) and a flexible region 2540 (constructed from a more flexible material, such as silicone). The flexible region is overmolded with the upper headgear connector 2535 and support arm 2400 (e.g., constructed from a more rigid material, such as nylon) to interconnect the headgear connector and support arm and provide flexibility to the forehead support to adjust the distance of the forehead support from the patient's forehead in use.

[0100] Each upper headgear connector 2535 has a loop hole 2536 for attaching the headgear and a connecting portion 2538 that helps mold the flexible region to the headgear connector. As shown, the slot 2536-1 extends into the hole 2536 to provide a loop-through configuration. The support arm has a connecting portion 2402 that helps mold the flexible region to the support arm. The connecting portions 2538, 2402 each have a respective retention slot 2538(1), 2402(2) that helps the overmolded silicone flexible region 2540 to mate or mechanically lock with the nylon headgear connector 2535 and support arm 2400. Also, as shown in FIG. 67, the silicone flexible region 2540 is thick enough (e.g., 0.5 mm or more thick on each side, e.g., 0.8 mm thick on each side) on each side of the nylon support arm 2400 to enhance the mating. In one embodiment, the flexible region may be thicker in the middle around the arm 2400 and taper towards the connector 2535.

[0101] As shown in FIG. 66 and FIG. 68, the headgear connectors 2535 and support arms 2400 can have features to aid in molding with the silicone flexible regions 2540 and to prevent flash and damage to the frame. For example, the support arms 2400 can have a lip 2404 to aid in molding the silicone flexible regions over the nylon arms. Also, each headgear connector 2535 can have a rounded wall 2539 (e.g., about 0.2 mm to 0.6 mm high, e.g., 0.4 mm high) to aid in molding the silicone flexible regions over the nylon headgear connectors. In one embodiment, the wall 2539 can be a crush bead that is crushed from the part when placed in the mold.

[0102] In a preferred embodiment, the headgear connector 2535 and the arm 2400 are formed separately from one another (e.g., three separate pieces) and then connected to one another by a flexible region 2540. In an alternative embodiment, the headgear connector 2535 may be connected to the arm 2400 by a runner 2555 (e.g., the headgear connector and arm are formed as one piece) and then overmolded with the flexible region, as shown in FIG.

[0103] In an alternative embodiment, the headgear connectors 2535 may include silicone connectors such as the lower headgear connectors 2520 described above.

[0104] 88-93 show various views of the frame 2020 and its forehead support arm 2400, upper headgear connector 2535, flexible region 2540 and lower headgear connector 2520. In one embodiment, the angle between the connectors 2535 may be about 100°-170°, for example 125°-145°, as shown in FIG. 91. FIGS. 94-98 show the frame 2020 of FIGS. 88-93 engaged with the cushion 6540 of FIGS. 71-87.

[0105] 3.Sealing mechanism The sealing mechanism 40 is configured to interface with the frame 20 and form a seal with the patient's nose during use. In this example, the sealing mechanism 40 provides a nasal interface adapted to engage the patient's face generally along the nasal bridge, cheek and upper lip regions of the patient's face. However, other interfaces, e.g., full face, are possible. The sealing mechanism provides a flexible configuration adapted to seal relatively quickly and maintain a seal during use. In one example, the sealing mechanism can be configured to seal with or without air pressure.

[0106] 3.1 Silicone cushion 1-1-1-4, the sealing mechanism 40 includes a cushion 42 constructed from a generally flexible material, including but not limited to silicone, TPE, gel, or other materials. The cushion can be molded from a material having a Type A durometer of about 35 to about 45, such as about 37 to about 42, and preferably about 40. The cushion 42 defines a breathing chamber or cavity adapted to receive the patient's nose and provide air communication to the patient.

[0107] The face-contacting side of the cushion 42 has a double-walled construction, where the cushion has an undercushion 44 and a membrane 46 (see, e.g., Figs. 1-4) that at least partially covers the undercushion 44. The membrane is generally softer and less rigid than the undercushion and provides a seal against the patient's face during use. The undercushion is generally configured to support the membrane and prevent collapse of the membrane when the nasal mask system is attached and fastened with headgear. In one example, the undercushion may be provided only along selected areas of the mask system, e.g., along the cheek areas, or not at all. The cushion may also be matte and / or colored, e.g., for easy fit and comfort.

[0108] 1-4 show a cross-section of the face-contacting cheek region of the cushion 42. As shown, the cushion includes a sickle or question mark shape with a base 60 and an upper portion 62 that is angled radially outwardly of the base 60, for example, to reduce size and perceived bulk, minimize dead space in the breathing cavity, and / or add more flexibility to the undercushion and membrane during use. Such a cross-section may be provided around the entire periphery of the cushion or only in selected areas of the cushion. In one example, the "question mark" shaped cross-section in the upper lip region may have a small curvature, for example, to prevent the cushion from overhanging into the patient's mouth and prevent nasal obstruction.

[0109] In one example, the gap or spacing 45 (see, e.g., FIGS. 1-4) between the membrane 46 and the undercushion 44 can be adjusted, for example, to reduce wrinkling and leakage. For example, the gap may be relatively small so that the membrane closely conforms to the shape of the undercushion. In one example, the cushion can be molded with a larger gap, but the membrane is preloaded to hinge closer to the undercushion after molding. In another example, a bellows 64 (as shown in dashed lines in FIGS. 1-4) may be provided or molded with the membrane to bias the membrane closer to the undercushion.

[0110] The non-face-contacting or frame side of the cushion 42 has one or more interface structures adapted to interface or otherwise removably connect to the frame 20. In the illustrated example, the cushion 42 has one or more elongated and spaced apart projections 50, for example along its sides and bottom, adapted to engage or mate with respective openings 27 along the sidewall 26 of the frame 20. As shown in Figures 1-1 and 2-1, such a configuration can provide positive reinforcement that the connection has been established, as the user can visually see the connection and, optionally, a proper connection can result in an audible click. Additionally, the cushion 42 has a notch or detent 52 along its top adapted to engage or mate with a bead or catch along the inside (not shown) of the frame sidewall 26, for example, to aid in alignment and prevent misalignment. However, it should be understood that the cushion may be connected or mated to the frame in other suitable ways.

[0111] For example, possible configurations for connecting the cushion 42 to the frame 20 are disclosed in US Pat. No. 6,399,323, the disclosure of which is incorporated herein by reference in its entirety.

[0112] The non-face-contacting side of the cushion 42 also has an opening 55 adapted to receive or otherwise communicate with an elbow 70, as described below.

[0113] Figures 1-5 through 1-12 show a cushion substantially similar to cushion 42 described above and designated with like reference numerals. In contrast, the cushion of Figures 1-5 through 1-12 does not have a notch or detent along its top.

[0114] As shown, the face-contacting side of the cushion (i.e., the side having the membrane 46 and undercushion 44) may be co-molded with the non-face-contacting side of the cushion (i.e., the side defining the opening 55 and breathing cavity) or may be formed separately and attached to the non-face-contacting side. Preferably, the face-contacting side of the cushion and the non-face-contacting side of the cushion are formed as a single component. Preferably, this single component may be made from a flexible sealing material that is relatively biocompatible when in contact with the patient's skin, including but not limited to silicone.

[0115] 1-9-1-12 show various cross-sectional views of the cushion. As shown in FIG. 1-9, the cushion may not have an undercushion in the nasal bridge region of the cushion. Also, as shown in FIG. 1-9, the curvature and / or length of the membrane and undercushion in the upper lip region are selected for range of fit, comfort, and to prevent occlusion of the nostrils. In contrast, the curvature and / or length of the membrane in the nasal bridge region may be flatter and longer than in the upper lip region, for example to increase sealing stability and range of fit. This is because the cushion must accommodate a variety of nasal bridge heights, including high and flatter nasal bridges, and therefore a longer membrane is required in the nasal bridge region. There is no undercushion in the nasal bridge region to allow for more flexibility and to apply less force to the sensitive area that is the nasal bridge. There is less anthropometric variation among patients in the upper lip region, which allows the membrane length to be shorter than the nasal bridge region. An undercushion is provided in the upper lip region to help stabilize the cushion in place on the patient's face.

[0116] While Figs. 1-11 and 1-12 clearly show a sickle or question mark shape through the cheek region of the face-contacting side of the cushion, Figs. 1-9 and 1-10 show the upper lip region substantially free of such a shape. The sickle shape is necessary in the cheek region to allow for more flexibility of the cushion to accommodate anthropometric variations in the patient's face. For example, some patients may have a generally flat face, which may require the cushion to flex from its substantially curved contour to a flatter contour. The cheek region may need to flex inwardly or downwardly. Alternatively, for patients with more angular or swept back cheeks, less flexing of the cushion may be required. In both scenarios, the patient should experience approximately the same level of comfort and therefore approximately the same level of force from the cushion to the face. The additional flexibility of the sickle shape allows for a range of flexing of the cushion with approximately the same force feedback to the patient's face.

[0117] Additionally, a lip seal 57 may be provided inwardly from the opening 55 to seal against the elbow in use.

[0118] 3.2 Foam cushion with silicone membrane In an alternative embodiment as shown in FIGS. 2-1, 2-2 and 2-4-2-8, the sealing mechanism 40 can include a foam cushion 241 and a silicone cushion or membrane 242.

[0119] The silicone cushion 242 defines a breathing cavity and is adapted to support or otherwise retain the foam cushion 241. As best shown in Figures 2-6, the face-contacting side of the silicone cushion 242 provides a dual-wall structure including an undercushion 244 and a membrane 246. The non-face-contacting side of the silicone cushion 242 has an opening 255 adapted to receive or otherwise communicate with the elbow 70.

[0120] The undercushion 244 and adjacent sidewalls 247 extending from the undercushion 244 are configured to hold the foam cushion 241. The undercushion 244 curves outwardly from the sidewalls 247 and away from the breathing cavity to provide a groove 248 that faces the membrane 246 that curves inwardly into the breathing cavity. As shown, at least the patient side of the foam cushion 241 is inserted into the groove 248 (see, e.g., FIGS. 2-2 and 2-6) defined by the undercushion 244, with the inner surface of the foam cushion 241 supported by the sidewalls 247. The foam cushion 241 can be held in place by an interference fit and / or a friction fit with the silicone cushion 242. The foam cushion 241 is disposed beneath the membrane 246 and within the undercushion 244, but not in the airway or breathing cavity. In use, the foam cushion 241 can absorb forces applied to the undercushion 244, for example along the cheek area of ​​the silicone membrane.

[0121] The non-patient side of the foam cushion 241 supports the foam cushion 241, and thus the silicone cushion 242, on the frame 20. As shown, the foam cushion 241 has one or more interface structures adapted to interface or otherwise removably connect with the frame. In the example shown, the foam cushion 241 has one or more spaced apart and elongated projections 250, for example along its sides, adapted to engage or mate with respective openings 27 along the side walls of the frame 20. However, it should be understood that the foam cushion may be connected or mated to the frame in other suitable manners, or the frame may be connectable to the silicone cushion along with the foam cushion, as the case may be.

[0122] In one example, the outer lip 249 (see, e.g., Figures 2-5) of the silicone cushion 242 (i.e., the junction between the membrane and the undercushion) can be configured to engage with the outer edge of the frame 20 such that the silicone cushion 242 and frame 20 seal the foam cushion 241.

[0123] In one example, the silicone cushion can be provided with a concertina or bellows type configuration in the nose bridge area to provide greater flexibility or allow more movement during use without compromising the seal. For example, the silicone cushion can have a collapsible portion, such as that described in U.S. Patent Application Publication No. 2009 / 0133994, filed Feb. 27, 2009, the disclosure of which is incorporated herein by reference in its entirety.

[0124] In one example, the membrane of the silicone cushion and / or the upper lip area of ​​the undercushion may be corrugated, for example to prevent blockage of the nostrils.

[0125] The foam cushion 241 may include skinned or unskinned foam. The foam cushion 241 may be open cell, closed cell, or a combination of open and closed cell. The foam cushion 241 may be die cut, molded, compression cut. The foam cushion 241 may be made from polyurethane foam, silicone foam, or any other suitable material. The foam cushion 241 may be made from the same material or a combination of materials, such as two types of foam with different properties. For example, the protrusions 250 may be made from a denser or harder foam than the rest of the foam cushion 241.

[0126] The cushion 242 may be made from materials other than silicone, for example, the cushion 242 may be made from TPE, gel-filled, or other suitable materials.

[0127] 3.3 One-size-fits-all cushion Cushions according to embodiments of the present invention can be configured to fit a wide variety of patient faces in only one size, i.e., to fit a wide variety of anthropometric measurements.

[0128] The undercushion can have slits or can be comprised of multiple individual narrow portions or fingers that can be configured to spread outward when force is applied by the user when donning the mask. The fingers are arranged to spread outward, thereby pressing or supporting the membrane over a larger area of ​​the patient's face. Additionally, the fingers can be configured to bend, flex, and move into crevices and creases in the patient's face (e.g., due to wrinkles in the patient's skin or on either side of the nose where the nostrils spread outward), thus supporting a seal in these normally difficult to seal areas.

[0129] 71-87 illustrate a cushion 6540 according to an embodiment of the present invention. As will be described in more detail below, the cushion 6540 provides a nasal interface adapted to engage the patient's face generally along the nasal bridge region NB, the nasal side regions SN (including the upper and lower sides of the nose), the nasal nose-to-lip crease or corner region CN, and the upper lip region UL of the patient's face (see, e.g., FIGS. 74, 78-82, and 94-98).

[0130] The face-contacting side of the cushion 6540 has a double wall construction, where the cushion has an undercushion 6544 and a membrane 6546 that at least partially covers the undercushion 6544. In the illustrated embodiment, no undercushion is provided in the nasal bridge region NB, see, for example, FIG. 79 and FIG. 95. As shown, for example, in FIG. 79, the free end of the membrane 6546 can have a bead 6546(I). The inclusion of the bead allows an orifice defined by the membrane to be molded into the cushion, such that no additional cutting is required to form such an orifice. In the illustrated embodiment, the membrane includes a relatively thin thickness, for example, about 0.2 mm to about 0.35 mm.

[0131] The cushion may have a sickle shape in one or more areas of the cushion, see for example the upper lip area, the side of the nose area and the corner of the nose area of ​​Figures 79-82. In use, the sickle shape of the cushion provides a hinge or flexure 6567 (see, e.g., FIG. 98) to facilitate controlled deformation of the cushion in use. Such a sickle shape of the cushion also allows one or more portions of the cushion to overhang the frame 2020 (see, e.g., FIGS. 95-98), which allows the frame to support one or more portions of the cushion as it deforms in use. In one form, this configuration provides a less stiff undercushion, which reduces the likelihood that the cushion will bottom out over the range of deformations used, and therefore makes the cushion more comfortable.

[0132] Fig. 117 illustrates flex points or flex regions BP for an undercushion or back-up band 6544 according to an embodiment of the invention, while Figs. 118, 119, and 120 illustrate flex points BP for undercushions of other configurations. Different cross sections may be used for different regions.

[0133] Preferably, the configuration shown in FIG. 117 is used in the upper lip area of ​​the undercushion or backup band. This configuration can be described as a double cantilever, depending on the relative thickness of the different portions. Increasing thickness increases stiffness. The cross-sectional shape may be arranged to extend laterally or radially outward of the adjacent sidewall, or in another version as shown in FIG. 118, the cross-sectional shape may be more consistent with the adjacent sidewall and have a similar radially outward extent by placing a fold or bend on the inside of the adjacent sidewall.

[0134] Preferably, the cross section shown in Fig. 119 is suitable for use along the side of the nose. This configuration can improve the lateral force applied to seal difficult areas of the face. This configuration can be described as a triple cantilever, depending on the relative stiffness of the different sections.

[0135] FIG. 120 shows an alternative configuration that can be described as a single cantilever beam.

[0136] The non-face-contacting or frame side of the cushion 6540 has elongated projections or locking tabs 6550 along its sides that engage or mate with the frame 2020 to secure the cushion in place, see for example, FIG. 97 and FIG. 98. The cushion 6540 also has a raised locking tab 6552 along its underside that interfaces or engages with the frame (see for example, FIG. 97 and FIG. 98) and a raised top tab 6554 that interfaces or engages with the frame at the apex of the cushion. FIG. 95 shows the tab 6554 that engages with the frame 2020 to help hold the cushion to the frame. The raised top tab 6554 can also provide assistance to robotic release of the cushion from the mold. However, it should be understood that the cushion may be connected, mated and / or aligned with the frame in other suitable ways.

[0137] The non-face-contacting side of the cushion also has an opening 6555 adapted to receive or otherwise communicate with an elbow. As shown, the opening can provide a vent mechanism such as those shown in Figures 13-1 and 13-2. However, it should be understood that the cushion may have alternative vent configurations such as those shown in Figures 55-59.

[0138] nasal bridge area As best shown in FIG. 79, the length or depth d1 of the membrane 6546 in the nasal bridge region ranges from about 10 mm to 30 mm, e.g., 15 mm to 25 mm, e.g., 19 mm to 20 mm, e.g., 19.58 mm. As shown, the depth d1 extends from the perimeter of the beginning of the membrane (i.e., where the thin seal can flex / hinge from the connecting portion 6547) to the tangent of the patient contacting portion. The depth d1 of the membrane in the nasal bridge region is relatively larger than in the art and is optimized to accommodate anthropometric variations. For example, a relatively tall nasal bridge may extend further into the membrane, while a relatively shallow nasal bridge may rest on top of the membrane with little or no membrane flexure.

[0139] When viewed from above, the shape or curvature of the membrane 6546 in the nasal bridge region is also configured to accommodate a wide variety of patient faces. As best shown in FIG. 75 (showing a scallop or curvature in the nasal bridge region and raised portions 6549 in the lateral regions of the nose), the depth d2 in the nasal bridge region is in the range of about 10 mm to 15 mm, e.g., 11 mm to 12 mm, e.g., 11.52 mm, and the width d3 in the nasal bridge region is in the range of about 10 mm to 20 mm, e.g., 15 mm to 16 mm, e.g., 15.35 mm.

[0140] Depth d2 is sufficient to accommodate most flattened noses, so that the edge of the membrane sits on the bridge of the nose and the raised portions 6549 sit on either side of the nose. A higher bridge will anchor to the sides of the nose at the raised portions and the membrane in the bridge area will flex to allow the bridge of the nose to move into the membrane in the bridge area and stop anywhere in zone z.

[0141] The width d3 is sufficient to accommodate a wide nasal bridge. The raised portion 6549 anchors at the side of the nose, causing the membrane to bend or stretch to accommodate the bridge of the nose. The width d3 is selected to accommodate the widest nose, so that the raised portion always sits above the harder bone tissue below the orbit to anchor, stabilize and position the cushion in the desired position.

[0142] In use, in one preferred form, the membrane or sealing flap is substantially unsupported by the undercushion in the nasal bridge area so that as the nose moves into the sealing portion, the membrane is in tension at the highest part of the nasal bridge. Moreover, it is preferably "pinched in" at the side of the nose in the area adjacent the highest point of the nasal bridge. The lateral force at the membrane can be configured to vary with the height of the nasal bridge. A deeper nasal bridge pushes further into the membrane, increasing tension in that area, drawing the sides of the cushion out and bending inward or jutting out, increasing the lateral force and improving the seal at the sides of the nose. For faces with a relatively low nasal bridge and high cheekbones, the area of ​​the cushion adjacent the nasal bridge can be widened outward, increasing tension in the membrane and increasing the sealing force against the relatively low nasal bridge. In a preferred form of the invention, the backup band or undercushion flexes relatively freely inward and outward compared to prior art cushions in the area adjacent the nasal bridge. See Figures 116-1-116-3.

[0143] Side of nose The undercushions 6544 at the sides of the nose are configured to anchor the cushion and position and stabilize the membrane due to the curvature of the face, especially as the nose transitions to the cheeks, which may vary from patient to patient. The undercushions position the membrane and maintain the membrane's contour to prevent it from wrinkling.

[0144] The undercushion 6544 has a flap or extension 6545 that is wider than other areas of the undercushion, such as the corners of the nose or upper lip area. This configuration ensures that in areas where the membrane is supported by the undercushion, a very thin nose can contact the membrane and ensures a smooth transition of the membrane from nose to cheeks. A wider nose contacts a wider area of ​​the membrane and a wider portion of the undercushion supports the membrane.

[0145] FIG. 74 shows various exemplary dimensions to provide an indication of the approximate location of the undercushion flap 6545. In one embodiment, d4 is about 5mm-15mm, e.g., 9mm-10mm, e.g., 9.26mm, d5 is about 10mm-15mm, e.g., 12mm-13mm, e.g., 12.80mm, d6 is about 20mm-25mm, e.g., 22mm-23mm, e.g., 22.10mm, and d7 (e.g., distance from bottom of flap to upper lip area) is about 10mm-20mm, e.g., 15mm-16mm, e.g., 15.58mm. FIG. 75 also shows an exemplary distance d8 from the top 6546 of the flap to the approximate contact point of the cushion at the upper lip area. The cushion will usually be located in approximately the same place on the patient's upper lip, but where the cushion may be located on the bridge of the nose may vary, and thus the flap is spaced a sufficient distance from the upper lip area to be located on the side of the nose.

[0146] FIG. 83 is a cross-sectional view of the widest portion of the flap 6545 of the undercushion 6544. As shown, the flap has a relatively large radius, which allows the undercushion to easily roll or flex inward without excessive pressure being applied to the sides of the nose (e.g., such pressure may cause a choking or pinching sensation in the nostrils). In one embodiment, the radius r1 of the outer surface is about 12mm to 20mm, e.g., 16mm, and the radius r2 of the inner surface is about 8mm to 16mm, e.g., 12mm. Also, the thickness t1 towards the free end of the flap is about 0.5mm to 1.5mm, e.g., 0.9mm, to allow easy flexing, and the thickness t2 from the free end of the flap inward is about 1.0mm to 1.5mm, e.g., 1.2mm, to facilitate hinging without collapsing the undercushion.

[0147] The length of the flap 6545 is measured from the top to where the flap connects to the frame or to the front of the cushion. The length of the flap is about 10mm to 30mm. Preferably, the length of the flap is about 15mm to 25mm. Most preferably, the length of the flap is about 18mm to 23mm. Most preferably, the length of the flap is about 20mm.

[0148] Nose wrinkles or corners The undercushion at the nose crease or corner is configured to stabilize or anchor the mask in this region. Also, the nose crease or corner is inherently difficult to seal because the shape of this region of the face can be complex, i.e., the nostril flares, upper lip and cheek regions come together in skin depressions and / or creases. In this region, the undercushion is more rigid to adequately support the membrane, so that the membrane can be positioned to abut or conform to this more complex shape. As shown in FIG. 84 (showing the undercushion for half of the cushion), the undercushion at the nose corner region includes a local thickening to increase its rigidity. In one embodiment, the local thickness t3 can be about 1 mm to 2 mm thick, for example 1.4 mm thick. 81 and 82 also show the undercushion at the nasal corner region CN and its relatively thicker thickness and narrower radius.

[0149] FIG. 85 shows a cross-section of the nose corner region of the undercushion 6544. In one embodiment, the radius r3 of the outer surface is about 5mm-15mm, e.g., 8mm, and the radius r4 of the inner surface is about 2mm-8mm, e.g., 4.85mm. Additionally, the thickness t4 of the tip of the undercushion is about 0.5mm-1.5mm, e.g., 0.85mm, and the thickness t5 of the peak of the undercushion is about 1mm-2mm, e.g., 1.4mm. The peak thickness t5 is relatively thick to stabilize the membrane and provide hinging motion about this point rather than the base b of the undercushion.

[0150] upper lip area As best shown in Fig. 79 and Fig. 95, the undercushion in the upper lip region UL is configured to accommodate sensitive gum tissue. Thus, the thickness of the undercushion in this region is about 0.5mm-1.0mm, e.g. 0.7mm. The thickness of the undercushion in the upper lip region may be the thinnest compared to other regions of the undercushion. The radius of the undercushion in the upper lip region is relatively large with the intention that the cushion rests on the upper lip region rather than anchoring it. In one embodiment, the radius of the upper lip region may not be constant, for example, the radius r5 at its center is about 65mm-75mm, e.g. 72.71mm, and the radius r6 towards the nasal corner region is about 30mm-40mm, e.g. 36.85mm.

[0151] Masks according to the present technology can adapt the sealing force depending on the size and shape of the wearer's face and nose. For example, in the upper lip area, the sealing force can be the result of both compression force through the undercushion or backup band and tension of the membrane or face flap. A wide nose can cause the corners of the cushion to spread outwards, increasing the amount of tension applied to the face to create a seal. Such a configuration may be suitable for flatter shapes of the face in this area.

[0152] Relationship between membrane and undercushion In the illustrated embodiment, the membrane may vary in distance from the undercushion in different regions of the cushion, i.e., the gap between the membrane and the undercushion may be different in different regions of the cushion. In regions with more diversity in facial morphology (such as the tip and sides of the nose), a wider gap may be provided to allow additional areas for the membrane to flex. Also, in regions such as the upper lip region where the membrane tends to stretch or apply a tensile force to the upper lip, a smaller gap may be provided to allow less flexibility and therefore more support for the membrane. Figures 76 and 79 show exemplary distances of the gap between the undercushion and the membrane in different regions of the cushion. In one embodiment, the distance d9 is about 5.8mm to 6.0mm, e.g., 5.89mm, d10 is about 4.8mm to 5.0mm, e.g., 4.93mm, d11 is about 4.2mm to 4.4mm, e.g., 4.29mm, d12 is about 4.0mm to 4.2mm, e.g., 4.06mm, d13 is about 3.2mm to 3.4mm, e.g., 3.3mm, d14 is about 3.4mm to 3.6mm, e.g., 3.49mm, d15 is about 3.7mm to 3.9mm, e.g., 3.76mm, and d16 is about 3.7mm to 3.9mm, e.g., 3.76mm.

[0153] Sealing force 86 and 87 are schematic diagrams illustrating an exemplary sealing force of the cushion viewed from the side and in front of a patient's nose in use.

[0154] As shown in Fig. 86, the cushion in the nasal bridge area does not seal along the sellion or fovea of ​​the nose as shown at A. Rather, the cushion in the nasal bridge area seals along the lower area of ​​the nasal bridge as shown at B. Because the cushion seals below the nose, a relatively large cutout in the undercushion in the nasal bridge area is provided (see, for example, cutout 6557 in Fig. 74). That is, because the nose gets wider toward the lower part of the nose, the cutout is wide enough to accommodate a wide range of patients.

[0155] The membrane in the nasal bridge region includes a stretching effect to apply a force to the bridge of the patient's nose, i.e., the stretch or elasticity of the membrane is used to apply a force to the bridge of the nose, and not the undercushion as in other areas of the cushion. For example, the cushion is pressed against the patient's face until no space or gap is provided between the membrane and the undercushion. Because there is no undercushion in the nasal bridge region, the membrane stretches as the cushion is pressed against the patient's face, i.e., stretches across the raised portion 6549 shown in FIG. 75. The stretching or expanding membrane provides a taut trampoline-like membrane portion that applies a force to the bridge of the nose.

[0156] For example, Fig. 116-1, Fig. 116-2 and Fig. 116-3 show the seal at the nasal bridge region NB by stretching and tensioning. Fig. 116-1 shows the cushion before contacting the patient's nose. As shown, the membrane or face flap 6546 is spaced from the undercushion or backup band 6544. Fig. 116-2 shows the nose contacting the membrane 6546 such that the membrane engages the undercushion, thereby placing the membrane in tension across the gap defined by the undercushion at the nasal bridge region (shown as a point load in this view). As the nose is pressed further into the cushion as shown in Fig. 116-3, the undercushion acts as a cantilever spring and begins to flex (shown as a point load in this view).

[0157] The surface of the membrane may be matte or polished to provide friction and improve sealing. Polishing the surface of the device can provide a more tacky feel and increase friction. A matte sealing surface can be provided by increasing the roughness of the device surface. A matte surface may be preferred in some areas.

[0158] As shown in FIG. 87 and FIG. 87-2, the curved flaps 6545 of the undercushion are configured to provide a sealing force into the sides of the nose and above the nose vents indicated by C. The curved flaps press against the sides of the nose and / or round at the sides, encircling the nose (except in the nose bridge area). There is no undercushion up to the top of the flaps. The gap G between the flaps is sized to accommodate the smallest noses, i.e., the gap is narrow enough to ensure that the flaps contact the sides of the nose of a wide range of patients. In one embodiment, the gap G is about 10 mm to 30 mm, e.g., 15 mm to 25 mm, e.g., 18.5 mm.

[0159] As a result of the preferred relatively large radius of the flaps 6545, each flap defines a bending point for a low bridge type nose that is well spaced from the rigid portion of the sidewall. In use, each flap bends or rounds without the low nasal bridge contacting the rigid portion of the sidewall. Fig. 87-1(a) shows an exemplary deformation of the flap for a low nasal bridge, and Fig. 87-1(b) shows an exemplary deformation of the flap for a high nasal bridge. This configuration is in contrast to undercushions known in the art that have a smaller radius that allows a wide / low nose to contact the rigid area of ​​the sidewall.

[0160] As shown in FIG. 87, the thickened undercushion in the nose corner area provides a sealing force in the plane of the patient's face at the nose crease, indicated at D. This area of ​​the face is less sensitive and can withstand a larger force to stabilize the mask on the patient's face. Sealing at the nose crease is important for the nose cushion as opposed to a full face cushion which passes through this area. Thus, the undercushion is relatively stiff in the nose corner or crease area and seals and stabilizes by digging in the crease and forcing the cushion into the plane of the patient's face. The cushion in the crease area also includes a sickle shape to provide a controlled deformation during use (see, for example, FIG. 82).

[0161] The undercushion in the lip area, which provides a sealing force on the patient's upper lip (designated E in FIG. 86), is relatively non-rigid (eg, compared to the crease area) for comfort.

[0162] The shape, size, roundness and / or thickness of the undercushion can be altered to vary the forces on different areas of the face.

[0163] 3.4 Alternative sealing mechanisms 5-1 through 5-6 show alternative embodiments of the sealing mechanism 440. The sealing mechanism 440 can have one or more protrusions 450 configured to be received in an opening in the body 422 of the frame 420 similar to those described above. The sealing mechanism 440 can also include a cushion as described above. For example, the sealing mechanism 440 can include an undercushion and a membrane, or a foam cushion and a silicone cushion as described above.

[0164] The cushion may have a double wall seal with the undercushion cut out or removed at the bridge of the nose. The undercushion at the upper cheek or sides of the nose may be raised to stabilize the cushion on the user's face. The cushion may have a polished outer surface and a matte inner surface. The cushion may be made of silicone or any other suitable material.

[0165] 3.5 Alternative cushioning 11-1, both sides of the cushion 540 have projections 550 which provide a retention feature adapted to mate with the frame as described above. The top of the frame has a landing 541 for branding and cushion retention, and each side of the frame has a cup-like portion 543 to aid in retention and to aesthetically match the land at the top of the frame.

[0166] 11-2 through 11-9 show various views of a cushion 540-1 according to another embodiment. As best shown in FIG. 11-8 and FIG. 11-9, the face-contacting portions of the cushion (e.g., membrane 546, undercushion 544 and sidewalls 542) provide a sickle or question mark shape for improved comfort and flexibility.

[0167] As best seen in Figures 11-6 to 11-9, cushion 540-1 has a shock absorbing portion 545 at the front of the cushion, i.e., the portion between the seal and the elbow. The shock absorbing portion is a thinned area, e.g. 1 mm thick compared to the rest of the cushion which is 2 mm to 3 mm thick.

[0168] 15-1 to 15-3 show various views of a cushion 540-1 engaging with a frame. Similar to the configuration described above, the cushion has protrusions 550 adapted to engage or mate with respective openings along the side walls of the frame 520.

[0169] In one embodiment, the undercushion in the upper lip area can be removed to prevent discomfort due to pressure on the patient's upper lip when the cushion is in use.

[0170] In one embodiment, the patient side of the cushion may include a matte finish and the non-patient side of the cushion may include a polished finish.

[0171] 3.6 Further alternative cushioning An embodiment of the cushion 2010 is shown in Figures 33-39. The cushion 2010 can be designed to be a one size fits all fit for a variety of patients. To accomplish this, different areas of the cushion 2010 can be tailored to flex and adapt to comfortably fit large and small noses.

[0172] The membrane 2040 contacts and seals with the patient's face in use. The nasal bridge region 2041 is configured to abut the bridge or top of the patient's nose in use. The nasal bridge region 2041 may be elastically deformable so that it can stretch over the patient's nose in use. The raised side portions 2042 may engage and compress the sides of the patient's nose that are adjacent to the patient's eyes in use. This compressive force may stabilize the engagement of the cushion at the sides of the patient's nose. The compressive force may also mean that for wide noses, the nasal bridge region 2041 stretches over the patient's nasal bridge. Alternatively, the nasal bridge region 2041 may rest or abut the patient's nose without stretching. Additionally, the nasal bridge region 2041 may be deeper or longer so that a patient with a high nasal bridge can place their nose over the membrane and flex the nasal bridge region 2041 of the membrane over their long nasal bridge in use.

[0173] The side flaps 2043 are longer or extend deeper into the mask cushion so that the cushion can seal with a flatter or shallower nose in use. The side flaps 2043 may be flexible so that they can flex into the cushion if the patient has a high nasal bridge.

[0174] The peaks 2046 on the membrane may be raised or higher when compared to other areas of the membrane, which may be to secure the cushion against the corners of the user's nose proximal to the nostrils or flares of the nostrils when in use.

[0175] The upper lip region 2044 is disposed at the bottom of the membrane and can engage or rest on the upper lip of a user in use. The curvature may be adapted to accommodate a variety of upper lip shapes of patients.

[0176] The flexible portion 2045 can be located proximal to the elbow or swivel ring connection on the cushion 2040. The flexible portion 2045 can be an area of ​​thinner or more flexible material that allows for separation of the tube from the cushion.

[0177] A locking tab 2601 can be located on at least a portion of the front region of the cushion. The locking tab 2601 can have a raised profile or peak that locks the cushion in place when assembled with the frame.

[0178] The fastening tab 2661 can also be located on at least a portion of the front region of the cushion. The fastening tab 2661 can also be higher than other portions of the cushion in order to interface or otherwise engage with the frame.

[0179] The top tab 2651 can be a raised portion located at the apex of the cushion. The top tab 2651 can be positioned to engage with the frame while allowing for easier robotic demolding of the cushion.

[0180] A vent or swivel ring 2090 may be positioned at the orifice of the cushion to receive an elbow or breathable supply of gas. The vent ring 2090 may be molded with the cushion 2010 or otherwise permanently attached to the cushion 2010. The vent ring 2090 may have vent holes in at least a portion of its periphery to allow for the exit of gas from the mask system.

[0181] 40-45 show the cushion 2100 and frame 2020 described above assembled together, according to an embodiment of the present invention.

[0182] 4. Elbow The elbow 70 has a first end 72 and a second end 74, see, e.g., FIGS. 1-2, 2-2, and 2-5. The first end 72 provides an interface structure configured to interface or otherwise attach to the sealing mechanism 40. The second end 74 is adapted to be connected to an air delivery tube. The first end is angled at approximately 135° relative to the second end. However, the first and second ends of the elbow may have other suitable angles relative to one another, e.g., 0°, 90°, 120°, etc.

[0183] In one embodiment, the elbow may be similar to that disclosed in U.S. Patent Application Publication No. 2008 / 0133634, filed Oct. 22, 2008, the entire disclosure of which is incorporated herein by reference.

[0184] 4.1 Connection of elbow to sealing mechanism The sealing mechanism 40 is configured to maintain the elbow 70 in an operative position against the patient's face; that is, the sealing mechanism can act as a support and bearing surface for the elbow 70. The sealing mechanism and elbow can be connected with a friction fit, a snap fit, a mechanical interlocking, or other suitable attachment mechanism. However, other suitable configurations for attaching the elbow to the sealing mechanism are possible.

[0185] In the illustrated example, a swivel ring 90 is provided to couple the elbow 70 to the sealing mechanism 40. It should be understood that such swivel ring 90 is an optional component and that the elbow 70 may be directly coupled to the sealing mechanism 40 without a swivel ring.

[0186] As best seen in FIG. 2-5, the swivel ring 90 has an annular groove 92 along its outer periphery adapted to mate with an annular flange 256 that defines an opening 255 in the silicone cushion 242 (or opening 55 in the cushion 42 in FIGS. 1-1-1-4). The inner periphery of the swivel ring 90 presents a relatively smooth annular surface 94 adapted to engage with an outer surface of the first end 72 of the elbow 70. The free end of the first end 72 presents an annular bead 73 that engages with an inner shoulder of the swivel ring 90, e.g., with a snap fit. Such a connection holds the elbow in place (e.g., preferably a relatively airtight connection) and allows the elbow to rotate or pivot relative to the sealing mechanism.

[0187] The swivel ring is constructed of a more rigid material than the sealing mechanism (e.g., made of plastic, silicone, foam). This configuration can facilitate connecting an elbow, e.g., a rigid elbow to a rigid swivel ring, rather than connecting the rigid elbow to a soft sealing mechanism. In one example, the swivel ring may be co-molded, mechanically overmolded, and / or chemically overmolded with a sealing membrane or cushion, e.g., to reduce parts. Alternatively, the swivel ring may be provided as a separate part, e.g., to allow for disassembly.

[0188] Also, the area of ​​the cushion surrounding the opening 55, 255 may be somewhat flexible to allow separation of the elbow from the remainder of the mask system, for example to reduce tube drag. For example, the separation mechanism between the cushion opening 55 and the elbow 70 may include a flexible gimble or membrane on the cushion 42 in the area of ​​the opening 55. A similar separation mechanism is described in U.S. Patent Application Publication No. 2009 / 0139994, filed March 4, 2009, the disclosure of which is incorporated herein by reference in its entirety. The thickness of the gimble region may be 1 / 3 the thickness of the cushion adjacent the gimble region. Preferably, the gimble thickness may be less than 1 / 3 the thickness of the cushion adjacent the gimble area. Most preferably, the gimble area thickness is less than 1 / 2 the thickness of the cushion adjacent the gimble area. Figures 79, 96 and 98 show another example gimble area 6565 on the front side of the cushion 6540 between the seal and the elbow opening. As shown, the gimble area includes a thickened area and a thinned area, the thinned area toward the elbow opening.

[0189] The sealing mechanism between the cushion and the elbow may be similar to that described in US Pat. No. 6,399,363, the disclosure of which is incorporated herein by reference in its entirety.

[0190] 4-1-4-4 show alternative configurations for coupling the elbow 70 to the cushion 42. In FIG. 4-1, the cushion 42 has a pinched lip seal 57 inwardly from the opening 55, adapted to seal against the end of the elbow 70 in use. FIG. 4-2 shows an alternative sealing mechanism for the lip seal 57 of FIG. 4-1. As shown, the lip seal 57(1) can seal against the end of the elbow 70, such as in the configuration of FIG. 4-1. Alternatively, the lip seal 57(2) can be configured to seal the periphery of the elbow 70. FIG. 4-3 shows the elbow 70 attached to the cushion 42 via a swivel ring 90 as described above. In this embodiment, the cushion provides an inwardly extending pinched lip seal 57 adapted to seal against the end of the elbow 70 in use. FIG. 4-4 illustrates an arrangement in which the swivel ring 90 provides an inwardly extending lip seal 91 adapted to retain and / or seal against the periphery of the elbow 70 during use.

[0191] In one example, a swivel may be provided at the second end of the elbow and adapted to connect to an air delivery tube. FIG. 4-5 shows an example of a swivel 95. FIGS. 4-6-4-9 show alternative configurations for forming a seal between the elbow 70 and the swivel 95. As shown in FIG. 4-6, a lip seal 96 may be provided (e.g., overmolded) on an inner surface of the swivel 95 to seal with the elbow. As shown in FIG. 4-7, the swivel 95 may have flange portions 97(1), 97(2) adapted to overhang each end of the elbow 70. In this embodiment, the elbow 70 defines a groove 71 that receives and retains an end of the swivel 85. In FIG. 4-8, the end of the swivel 95 has a resilient clip portion 98 adapted to clip onto the flange 73 of the elbow 70. Also, a lip seal 96 may be provided on an inner surface of the swivel 95 to seal with the elbow 70. The lip seal 96 may be configured to be biased into engagement with the elbow 70 during use. Figures 4-9 show a swivel 95 in which an internal lip seal 96 is formed separately from the swivel 95 and attached thereto, for example, by spin welding or adhesive.

[0192] Vent mechanism As shown in Figures 1-1 and 1-2, elbow 70 includes a vent mechanism 75 for gas flushing. Vent mechanism 75 includes a plurality of holes (e.g., 5-100 holes, e.g., 20-50 holes, or about 45 holes). As shown in Figures 2-5, each hole may have a gradual undulation or taper along its length. However, it should be understood that the vent mechanism may include other suitable configurations, e.g., different numbers of holes, hole configurations, vent inserts with one or more vent holes, etc.

[0193] The vent may be a diffuse vent as disclosed in US Patent No. 6,399,633, the disclosure of which is incorporated herein by reference in its entirety.

[0194] 4.3 Alternative Elbows 12-1-12-3 show various views of an embodiment of a non-vented elbow, and 12-4-12-8 show various views of another embodiment of a non-vented elbow. Each elbow 570 has a cushion connection end 570(1) adapted to connect to a cushion and a tube connection end 570(2) adapted to connect to an air delivery tube. In 12-4-12-8, the sides of the elbows provide "button" points or flexible fingers 573 for a user to grip and quickly release the elbow from the cushion.

[0195] As best seen in Figures 12-4-12-8, the elbow includes flexible regions 571 (made of soft, tactile TPE or flexible polymers) that can be co-molded with more rigid regions (made of polymers such as polypropylene or polycarbonate). The flexible regions allow portions of the elbow to flex inwardly when the patient pinches or squeezes these regions, allowing separation of the cushion connection ends from the mask.

[0196] This configuration also allows for sealing of the elbow, soft feel features to add value, some color on the part to make it more attractive and easy assembly.

[0197] As shown in Figure 12-9, there may be a stop 575(1) within the elbow to prevent the flexible area from blocking the airway in use. A support beam 575(2) may be provided inside the elbow to provide strength to the elbow annulus and to keep the stop in place.

[0198] In one embodiment, a TPE portion can be molded onto the cushion connection end of the elbow to allow for better sealing and ease of rotation of the elbow when connected to the cushion.

[0199] The elbow can be made non-vented by using a vent ring as described below.

[0200] In one embodiment, the elbow may include a matte finish.

[0201] 4.4 Swivel / Bent Ring The swivel / vent ring is provided to provide an interface between the cushion and the elbow, i.e., to allow the elbow to connect to the cushion. As shown in FIG. 13-1, ring 590 provides an interface 591 for cushion connection, an interface 593 for elbow connection, and vent holes 595 along the periphery of the ring to provide diffuse ventilation. In one embodiment, the ring can be co-molded with the cushion (either by chemical or mechanical retention).

[0202] The ring provides ease of flow adjustment (i.e., vents can be added or removed), improved CO2 washout, control of humidification requirements, improved diffusion, non-intrusiveness, ease of elbow manufacture due to the absence of vents in the elbow, and / or facilitates aesthetic freedom of the elbow.

[0203] In one embodiment, a ring can be provided (e.g., co-molded) with the lip seal. For example, as shown in FIG. 13-2, the ring can be molded with a groove 596 between the patient-side vents 595, such that the vent ring can be placed on the tool to create the cushion, and when the material to create the cushion is filled into the tool, some of the cushion material will flow through the groove between the vents and form the lip seal 597. The lip seal 597 can provide a more effective seal between the cushion 540 and the elbow 570. Molding the lip seal into the vent ring is advantageous in reducing patient-operated parts.

[0204] In one embodiment, the ring may be non-vented (i.e., without vents) for use in a non-vented mask embodiment or a vented elbow.

[0205] 4.5 Alternative Elbows and Swivels 46-50 show an embodiment of an elbow 3000 and a swivel 3500. FIG.

[0206] The elbow 3000 has a first portion 3010 adapted to connect to a mask (e.g., the vent ring 2090 of the cushion 2010 described above) and a second portion 3020 provided with a swivel 3500 adapted to connect to an air delivery tube. In one embodiment, the swivel (e.g., constructed from nylon) may be overmolded to the elbow (e.g., constructed from polypropylene), for example, the second portion of the elbow has a stepped shoulder 3030 for overmolding the swivel and blocking the tooling. However, the swivel can be connected to the elbow in other suitable ways, for example, with a snap fit. The swivel is provided with an annular ring 3600 that provides a stop for connecting the air delivery tube.

[0207] The first section has a flexible quick release mechanism for attaching the elbow to a mask, for example, a vent ring 2090 of the cushion 2010. The mechanism includes a button 3100 on one or both sides of the first portion and a groove 3200 surrounding each button that allows the button to flex relative to the first portion. The buttons are raised for ease of use and tab movement. The profile shape of the buttons may vary, for example, for function and / or tooling. Each button also has a tab or catch 3040 adapted to engage, for example, by a snap fit, with the vent ring 2090 to releasably secure the elbow to the cushion 2010.

[0208] Additionally, at least a portion of the buttons are constructed from a soft tactile material (e.g., TPE) to aid in ease of use, for example. As best seen in Figures 49, 53 and 54, grooves 3070 are provided between the buttons to allow for the flow of the TPE or soft tactile material. Also, internal stops 3300 are provided to prevent the buttons from being pushed too far into the elbow cavity and potentially breaking.

[0209] As shown, the first portion is provided with upper and lower tabs 3050 that interface with the vent ring 2090 to prevent the elbow from being pushed too far into the vent ring.

[0210] 108-112 show alternative views of the elbow. FIG. 108 shows the overmolding of a swivel 3500 onto the elbow 3000, and then the overmolding of a button 3100 onto the elbow. As shown, the elbow has a retaining stop 3040, a support surface 3041 to facilitate rotation relative to the cushion, a sealing lip 3043 to seal with the cushion, and an insertion stop 3045 (located on the top, bottom and sides of the first portion of the elbow) that provides a stop for connecting the cushion. FIG. 109 shows an internal stop 3300 that prevents each button from being over-depressed. As shown in FIGS. 110 and 111, the button 3100 can have a step 3101 (e.g., 0.85 mm or more) along its periphery that overhangs the elbow. Such a step provides a flat uniform area for the button to travel in use. In an alternative embodiment, the step may be thinner (e.g., 0.35 mm), as shown in FIG. 113 and FIG. 114. As shown in FIG. 112, the button may have a concave portion 3103 along its periphery that is generally thin (e.g., about 0.4 mm thick) to facilitate depression of the button. The portion 3103 may be formed from an elastomer such as TPE or silicone. The portion 3103 may seal the button to the elbow body to seal an air path through the elbow. In one embodiment, the depression force F may be less than about 10 N. In an alternative embodiment, the concave portion 3103 may be thicker 3103 (e.g., about 1.3 mm), as shown in FIG. 115, thereby increasing the depression force. It should be understood that the thickness of the concave portion may be adjusted to adjust the force.

[0211] As mentioned above, ventilation for the mask is provided by the vent ring 2090. This configuration offers several advantages, such as ease of flow regulation, improved CO2 washout, control of humidification requirements, improved diffusion, less intrusiveness, ease of elbow manufacturing, and / or aesthetic freedom of the elbow.

[0212] 5. Alternative Vent Assembly 55-59 show an alternative vent 4000 that may be molded into or with another portion of the mask assembly. An embodiment of the invention relates to an assembly of interconnected vent structures joined together by an element or structure at a first position, which can be deformed to move the vent structures to a second position.

[0213] Although embodiments of the present invention relate to the vent 4000 being molded into the cushion 4500, it is also possible for the vent 4000 to be molded into any other part of the mask assembly in the airway, such as the tube, elbow or frame.

[0214] The vent 4000 can have a first structure that interconnects the vent array, such that when the shape of the first structure changes, the placement or position of the vent array also changes.

[0215] FIG. 55 shows an embodiment of a vent 4000. The first structure may comprise a stem 4100 and / or at least one branch 4150. The stem 4100 may support an array 4200 of vent branches. The stem 4100 may be central to the branches 4150. The stem 4100 may position and / or maintain the branches 4150 at a defined interval or array. The stem 4100 may also be configured to aid in alignment of the vent 4000 with respect to the cushion 4500 or other mask system elements (e.g. elbow, frame, etc.).

[0216] The embodiment of the stem 4100 shown in Figure 55 has a ring or circular configuration. It should be understood that the stem 4100 may have alternative configurations such as rectangular, triangular, or any other shape that meets the desired results of positioning and aligning the vent 4000 and spacing the branches 4150 within the mask system.

[0217] The stem 4100 may have an opening 4600. The opening 4600 may be configured and arranged to receive a portion of a mask system. For example, as best shown in Figures 58 and 59, the opening 4600 is arranged to receive an elbow of a mask system.

[0218] The branches 4150 can connect the stem 4100 to the vent array 4200. The branches 4150 can be evenly spaced about the stem 4100 or can have alternative configurations. The spacing of the branches 4150 can be configured to distribute the airflow flow exiting the vent array 4200.

[0219] In another embodiment, the branch 4150 may be selectively deformable. The branch 4150 may be formed in the first location by molding, cutting, or any other forming method. The branches 4150 can then be deformed to a second position by heating, cooling, force or other methods. In one embodiment, the branches 4150 can be deformed by placing the vent 4000 in an appliance for a mask component, closing the appliance so that the shape of the appliance bends or otherwise deforms the branches, and injecting or otherwise adding a second material into the appliance to allow the second material to fix or stabilize around the vent 4000 to maintain the branches 4150 in their deformed positions.

[0220] In one embodiment, the second position or deformation position of the fork may be between 0° and 120° from the first position. In one embodiment, the second position or deformation position of the fork may be between 30° and 90° from the first position. In one embodiment, the second position or deformation position of the fork may be between 40° and 60° from the first position. In one embodiment, the second position or deformation position of the fork may be 45° from the first position.

[0221] In another embodiment, the stem 4100 may be selectively deformable. The stem 4100 may be formed in a first position by molding, cutting or any other forming method. The stem 4100 may then be deformed to a second position by heating, cooling, force or other methods. In one embodiment, the stem 4100 may be deformed by placing the vent 4000 in an appliance for a mask component, closing the appliance so that the shape of the appliance bends or otherwise deforms the stem, and injecting or otherwise adding a second material into the appliance to allow the second material to fix or stabilize around the vent 4000 to maintain the stem 4100 in its deformed position.

[0222] In one embodiment, the second position or deformation position of the fork may be between 0° and 120° from the first position. In one embodiment, the second position or deformation position of the fork may be between 30° and 90° from the first position. In one embodiment, the second position or deformation position of the fork may be between 40° and 60° from the first position. In one embodiment, the second position or deformation position of the fork may be 45° from the first position.

[0223] 55-57, the branches can connect to at least one vent array 4200. The vent array 4200 can comprise a body 4240 and at least one vent hole 4250.

[0224] 56 and 57, the body 4240 may be generally rectangular, or any other shape that can accommodate at least one vent 4250. The body 4240 may also include a ledge or protrusion 4230 that can serve to mechanically join or lock the vent 4000 in place when formed with a mask component, such as the cushion 4500.

[0225] In one embodiment, there is at least one vent hole 4250 on each body 4240. In the illustrated embodiment, there are four vent holes 4250 disposed on each body 4240, as shown in Fig. 55. However, there can be any number of holes, for example, 1, 5, 10, 11 or more holes.

[0226] In one embodiment, the vents 4250 may be tapered, i.e., their inlets may be larger in diameter than their outlets. In one embodiment, their outlet diameter is about 0.1 mm to 2 mm. In one embodiment, the outlet diameter is about 0.3 mm to 0.8 mm. In one embodiment, the outlet diameter is about 0.7 mm. In one embodiment, the vents have an aspect ratio of about 1:3.

[0227] 58 and 59 show vents 4000 positioned on cushion 4500. Vent array 4200 is distributed around opening 4600. FIG. 59 shows longitudinal axis 4155 of branch 4150 positioned at angle α relative to axis 4610 of opening 4600. Thus, vents 4250 in body 4240 are positioned to position the outgoing airflow stream from vent 4250 at angle α relative to opening 4600, so that the individual airflows exiting each vent are spread out or dispersed. This diffuses the airflow path, thus reducing the blowing of airflow onto bedmates or bedding. This configuration can also reduce vent noise.

[0228] In an alternative embodiment, a similar vent 4000 may be placed in an elbow where the vent 4000 is formed in a first location and then placed in a mold for the elbow where the branches and vent array are deformed approximately 90° from their first location so that they are positioned around a portion of the elbow, and material for the elbow component is then injected into the mold to set and thereby maintain the vent 4000 in the desired location.

[0229] The vent 4000 may be constructed from a flexible and / or stretchable material. The vent 4000 may be constructed from nylon, polypropylene, thermoplastic elastomers, silicone, polycarbonate, polyurethane, or any other moldable, selectively deformable polymer.

[0230] The mask component in which the vent is formed can be made from a material that has a lower melting point than the material used for the vent because the vent will not melt when it is inserted into a mold for the mask component and a second material for the mask component is injected or otherwise inserted into the mold.

[0231] 64 and 65 show alternative views of the vent 4000 located on the cushion 4500. As shown, the vent mechanism molds multiple vent holes 4250 into the draw lines on the plastic cushion ring, which are then bent during the overmolding process to form a very diffuse, noise-free vent array around the elbow 3000. This array is sealed and suspended within the silicone material of the cushion 4500.

[0232] 99-105 show various views of a nasal mask system 6600 having a frame 6620 (e.g., as shown in Figs. 88-93), a cushion 6640 (e.g., as shown in Figs. 71-87 with vents 55-59 and 64-65), and elbows 6670 (e.g., as shown in Figs. 46-50), according to an embodiment of the present invention. Figs. 106 and 107 show a mask system 6600 in which headgear 6680, e.g., headgear having upper side straps 6682 that pass over the ears and lower side straps 6684 that pass under the ears, is placed on the patient's head in use. In one embodiment, the mask system can be used with headgear as described in U.S. Patent Nos. 5,993,333 and 5,993,351, each of which is incorporated herein by reference in its entirety.

[0233] Alternative Vents 60 and 61 show an elbow 6000 with a vent 6050 according to another embodiment of the present invention. In the illustrated embodiment, the vent 6050 has a vent plate 6052 having one or more vent holes 6054 formed therein. The vent plate also has a weakened or bendable area 6056 (i.e., hinge). A swivel 6070 may be provided on the elbow for attachment to an air delivery tube. Each vent hole may have a gradual undulation or taper along its length. However, it should be understood that the vent may have other suitable configurations, such as different numbers of holes, hole arrangements, etc.

[0234] In one embodiment, the vent 6052 can be molded with the vent 6054 and the hinge 6056. The bent plate can then be placed into the mold for the elbow 6000. When the mold for the elbow is closed, the hinge of the bent plate allows the bent plate to bend from a first position (as shown in FIG. 60, which shows the bent plate in a generally upright position on the elbow mold) to a second use position (as shown in FIG. 61, which shows the bent plate bent to engage the elbow). When the mold for the elbow is closed, the material for the elbow is injected into the mold and the bent plate is maintained in its second use position by the molded elbow. Additional components can also be molded onto the elbow (e.g., elbow button 6060 as shown in FIG. 61).

[0235] 62 and 63 show a vent 6150 according to another embodiment of the present invention. In this embodiment, the vent 6150 is in the form of a vent insert that is molded (e.g., co-molded) with the cushion 6140. The vent insert is located along the top of the cushion above an opening adapted to receive an elbow. As shown, the vent insert has a number of vent holes 6152 that are oriented to direct exhaust gases away from the patient's face in use. Additionally, the vent holes can be positioned to diffuse the flow of the exiting airflow. It should be understood that the vent may include other suitable configurations, such as contoured vent holes, different numbers of holes, hole arrangements, etc.

[0236] 6. Headgear Headgear can be removably attached to the headgear connectors 34, 36 of the frame 20 to maintain the nasal mask system in a desired position on the patient's face. In the illustrated example, the frame provides a four-point connection for a pair of upper headgear straps and a pair of lower headgear straps. However, the frame may provide other configurations, for example, a two-point connection or a three-point connection. One or more of the straps may be provided with a stiffening or reinforcing material.

[0237] The headgear can be constructed from elastic or flexible materials such as woven or non-woven fabrics, TPE, polypropylene, nylon, or any other suitable material. The headgear may also be reinforced with stiffening members that can add stability.

[0238] In one example, the nasal mask system can be used with headgear such as that described in U.S. Patent Application Publication No. 2008 / 0233636 filed Dec. 10, 2008, and U.S. Patent Application Publication No. 2009 / 0233636 filed Jan. 29, 2009, each of which is incorporated herein by reference in its entirety. In one example, attachment / adjustment of such headgear can be provided by buckles or hook-and-loop material. For example, the headgear straps can be constructed of a nylon elastic material with strap adjustment provided by buckles without any hook-and-loop material.

[0239] However, the nasal mask system may be used with alternative headgear configurations. For example, Figures 3-1 to 3-79 show headgear strap configurations and headgear connection configurations according to alternative examples of the present invention.

[0240] 3-1-3-4 show alternative configurations for sizing the headgear straps. FIG. 3-1 shows a headgear with a two-piece top strap adjustment. Each side 5001(1), 5001(2) of the top strap can be adjusted by ladder locks or buckles connected to the mask, or Velcro® adjustments, or other suitable means. This configuration provides a center adjustment, can be pulled evenly, and provides a wider range of fit. Additionally, the rear of the headgear straps can be made narrower or wider by sliding the rear strap 5003 (shown generally vertical, but may be angled in other ways) over the lower headgear strap 5004. FIG. 3-2 shows a headgear with a single top strap 5001 and a single lower strap 5004. The top and lower straps can preferably be constructed of elastic or other suitable stretchable material to provide a wide range of fit. This configuration allows for minimal or no adjustments and may also eliminate the need for buckles or external parts to the mask system. FIG. 3-3 shows head gear with an adjustable top strap with sides 5001(1), 5001(2), where one side of the top strap is provided with a buckle 5002 so that the adjustment of the length of the top strap is independent of the mask (i.e., forehead support). This can provide advantages such as one adjustment point and low profile. FIG. 3-4 shows head gear with a one-piece top strap 5001 with adjustment and an alternative buckle 5002. The buckle can be hinged at one end (e.g., hinge 5002(1)) so that when placed perpendicular to the head gear strap, the buckle teeth 5002(2) separate from the strap 5001 so that the strap can pass through the buckle to adjust the length in use. When the buckle 5002 is positioned parallel to the headgear strap, the teeth 5002(2) of the buckle engage the strap 5001 and prevent it from slipping within the buckle, thus locking or fixing the length of the top strap.Such a configuration can provide advantages such as a single adjustment point and a simple fastening mechanism.

[0241] 3-5-3-7(b) show alternative configurations for sizing the bottom or lower headgear straps. FIG. 3-5 shows the overlap of the lower straps 5004 so that at their ends, the overlapping ends 5004(1) slidably engage with the lower headgear connectors. The lower strap ends can be threaded through adjustment buckles 5005 so that sliding of the buckle along the length of the lower headgear straps can adjust the amount of overlap of the lower straps, and therefore their length, in use. Such configurations can advantageously provide a simple adjustment mechanism and obviate the need for conventional adjustment means such as hook and loop. FIG. 3-6 shows the overlap of the lower straps 5004 so that at their ends, the overlapping ends slidably engage with the lower headgear connectors. The lower strap ends can be attached along the length of the lower strap material using hook and loop attachment (e.g., the lower strap headgear material is a loop material and the end portions 5004(2) of the lower straps are hook material). Such a configuration advantageously provides simple hook-and-loop connections and slim lines. Figures 3-7(a) and 3-7(b) show an adjustment mechanism that can be utilized anywhere on the headgear, but more preferably on the upper or lower headgear straps. This adjustment mechanism can have a push-through mushroom connector 5010 present on one part of the headgear that can engage with a selected hole 5012 on another part of the headgear to avoid sliding adjustment on the headgear part. Advantageously, this configuration still allows the headgear parts to rotate on each other. Furthermore, this configuration can have positive feedback (e.g., a clicking sound) when the adjustment mechanism is locked in place, meaning that the patient knows when their headgear is adjusted. One or more holes and / or one or more mushroom connectors may be provided on the headgear.The adjustment mechanism may be constructed from a material that is flexible yet sufficiently rigid so as to maintain its connection when in use, such as TPE, silicone, polycarbonate or any other suitable material.

[0242] 3-8 through 3-13(b) show alternative fixed or adjustable headgear configurations. FIG. 3-8 shows a headgear strap size adjustment, where a loop of material 5014 having a hole 5014(1) is provided to allow for sliding engagement with the headgear strap 5004 (e.g., lower strap). The headgear strap can be provided with one or more mushroom-type connectors 5016 that interface or engage with the hole 5014(1) provided in the loop of material. Preferably, size indicators (e.g., S, M, L or 1, 2, 3, 4, 5, etc.) are provided on or near the mushroom connector to specify the size to which the headgear has been adjusted. This configuration may be advantageous as it provides a simple, known adjustment mechanism and the ability to know to which size the headgear has been adjusted. FIG. 3-9 shows a back strap size adjustment (which may be adapted for use with top straps, rear straps, or any other headgear straps), where the back straps 5006 may be provided with size-indicating markings 5007 (e.g., S, M, L, XL, etc.). The manufacturer, patient, or other suitable person may select which size the headgear straps should be adjusted to and align the adjustment markers (e.g., by folding or cutting the straps to align the markers) so that the headgear is positioned to correspond to the selected size, after which the headgear straps may be permanently secured in this position using stitching, ultrasonic welding, or other suitable technique. Such a configuration provides a low-profile connection that is permanently secured in one go without adjustment. FIG. 3-10 shows a central back strap 5008 constructed from elastic or other suitable flexible material, with adjustable arms similar to those shown in FIG. 3-7(a) and FIG. 3-7(b), i.e., mushroom connector 5010 and hole 5012 configuration. FIG. 3-11 shows a headgear with two positions for top strap adjustment, i.e., a hook-and-loop connection 5015 (e.g., as shown in FIG. 3-7(a) and FIG. 3-7(b)) and a mushroom connector and hole mechanism 5016. This configuration allows for greater adjustability and therefore can accommodate patient heads of various sizes. FIG. 3-12 shows a headgear connection that allows a first headgear strap 5004 (such as a lower strap) to be slidably engaged with a second headgear strap 5003 (such as a rear strap). The second headgear strap 5003 may be provided with a loop or additional layer of material 5003(1) that is ultrasonically welded, sewn, or otherwise attached to the second headgear strap.The first headgear strap is disposed in the space or groove between the second headgear strap and the layer of additional material. The ultrasonic weld or stitching or other attachment means can have ridges or protrusions in the groove between the second headgear strap and the layer of additional material that provide more friction to prevent excessive sliding of the first headgear strap through the groove. The layer of additional material can be the same as the headgear material or a more durable component such as TPE or silicone. Figures 3-13(a) and 3-13(b) show a sliding clip adjustment, where the headgear strap 5018 is looped through a clip 5020, and the headgear strap 5018 can be adjusted by pressing a button 5020(1) on the clip to engage or disengage an internal spring. The ends of the headgear straps can be provided with holes 5018(1) for attachment to a frame or forehead support. This hole can be reinforced (e.g., with a laminate, stitching, or other reinforcing means) so that reinforcement 5018(2) can keep the hole from widening and the sliding clip from slipping off the headgear material.

[0243] Figures 3-14(a)-3-14(h) show alternative configurations for sizing headgear straps. In one embodiment, the straps may be ultrasonically welded, may have ultrasonically cut holes, or may be ultrasonically modified.

[0244] FIG. 3-15 shows a similar configuration to FIG. 3-8 with a different shaped mushroom connector 5016 (ie, generally square shaped) to interface with the hole 5014.

[0245] 3-16(a) and 3-16(b) show an alternative configuration to FIGS. 3-8 and 3-15, whereby similar size indicators are used, but the headgear straps are threaded differently. A first end 5021(1) of a first headgear strap is looped through a first side of a second headgear strap 5022. A second end 5012(2) of the first headgear strap is looped through a second side of the second headgear strap 5022. Either the first end or the second end of the first headgear strap can have a size indicator. The second headgear strap can have a hole 5023 or other means to display the size indicator on the first headgear strap.

[0246] 3-17-3-24 show alternative configurations of connection to the headgear frame or forehead support. FIG. 3-17 shows a bottom strap 5024 that can wrap around an arm or hole 5025 in the frame and then reconnect with the bottom strap by a button or hook-and-loop material. This configuration can provide a simple, intuitive connection, with the possibility of multiple adjustment positions if multiple connections are provided, a slim line design, and ease of manufacture. FIG. 3-18 shows a bottom strap 5024 that can have a hook-type clip 5025 (e.g., made of plastic or other suitable material) welded, sewn, or laminated to one or both ends of the bottom strap material. The hook can snap into a receptacle 5026, slot, or hole in the frame. Such a connection means can provide a simpler plug-in connection, slim lines, and ease of manufacture. FIG. 3-19 shows a headgear strap 5024 with a series of fingers 5027 located at the end of the strap that can be welded or sewn or otherwise attached. The frame may be provided with similar fingers 5028, which prevent or minimize lateral movement, and therefore sliding, of the headgear strap away from or towards the frame when the fingers of the headgear strap interlock or overlay the fingers of the frame. Separation of the fingers in the direction of the fingers may be relatively simple when compared to separation of a normal headgear clip (e.g., the headgear clip provided by ResMed Mirage Quattro™). FIG. 3-20(a) and FIG. 3-20(b) show a headgear strap 5024 that can be provided with a T-bar 5029 at its end(s). The T-bar can be made of a flexible material such as TPE, silicone, polycarbonate or any other suitable material. The T-bar can be attached by looping the headgear strap through a hole provided in the T-bar connecting rod. Alternatively, the T-bars may be welded, sewn, ultrasonically welded, or attached by any other suitable means.The T-bar may loop over or around a receptacle or fastener 5030 provided on the frame. FIG. 3-21 shows a headgear strap with a push-in connection means 5031 attached to its end(s). The push-in connection means may be constructed of a generally flexible material such as silicone or TPE. The push-in connection means may be attached to the headgear strap by similar means as described for the T-bar shown in FIG. 3-20(a) and FIG. 3-20(b). The push-in connection means may be a spherical rod that may engage with a hole or slot 5032 in the frame. The frame may be provided with multiple holes or slots. FIG. 3-22 shows a headgear strap 5024 that forms a loop at its end and is sewn or otherwise reattached to itself along its length. The looped portion slidably engages around a receptacle 5033 on the frame. Hook material may be provided on the looped portion of the headgear strap to allow adjustment and later fastening of the headgear strap. The headgear material may need to be constructed from a looped material to allow for the engagement of the hook material. FIG. 3-23 shows headgear straps 5024 that loop over notches or barbs 5034 in the frame. The headgear straps can be adjusted by sliding spring clips 5035, whereby a spring mechanism in the clip allows for engagement and disengagement of the headgear straps. FIG. 3-24 shows a headgear connection hook 5036 with a grooved receptacle to allow the headgear straps to be fed into it.

[0247] 3-25(a)-3-20 show alternative configurations for connecting the headgear to the frame. Fig. 3-25(a) and Fig. 3-25(b) show headgear straps with "R" shaped clips 5037 attached to the end(s). The "R" shaped clips can be repelled or biased to preferably be maintained in their locked position. The frame can be provided with loops 5038 (e.g., lower headgear connectors as shown in Fig. 3-25(a) and Fig. 3-25(b)) that engage with the "R" shaped clips (shown in cross section). Fig. 3-26(a) and Fig. 3-26(b) show headgear straps with slots or cylinders 5039 at the end(s) through which frame extensions or fingers 5040 pass. Figure 3-27 shows an open ended headgear strap receptacle 5041 that allows the headgear strap loops to be wrapped or looped vertically around the frame, but with a slit in the front of the receptacle. Figure 3-28 shows a generally "U" shaped headgear connection receptacle 5042 on the frame. Such a configuration may be preferred to vertical insertion (indicated by the line drawing) of the headgear strap loops 5043. When the headgear strap loops are inserted into the headgear connection receptacles, they can proceed from one side of the "U" shaped receptacle to the other, thus preventing accidental disassembly of the headgear strap loops from the headgear connection receptacle since the headgear strap loops are anchored in the "U". FIG. 3-29 shows hook or loop material 5044 attached directly to the frame to interface with opposing hooks or loops from the headgear straps. FIG. 3-30 shows a magnetic attachment, where the frame is provided with magnets 5045 and the headgear straps are provided with magnets 5046. FIG. 3-31(a) and FIG. 3-31(b) and FIG. 3-32 show alternative configurations for the headgear attachment location to the frame. Figures 3-31(a) and 3-31(b) show headgear attachment receptacles or slots 5047 located on the periphery of the frame that reduce the vertical bulk of the mask. Figure 3-32 shows headgear attachment receptacles 5048 located on the frame and adapted to receive headgear clips 5049 associated with headgear straps similar to those disclosed in U.S. Patent No. 5,399,633, the disclosure of which is incorporated herein by reference in its entirety.

[0248] Figures 3-33 and 3-34 show alternative configurations for attaching the cushion to the frame or the lower headgear straps of the frame. Figure 3-33 shows a headgear connection loop 5050(1) located at the end of a headgear connection arm 5050(2). This configuration allows the headgear connection to be spaced away from the frame, which allows for a more streamlined appearance. Figure 3-34 shows a skeleton frame 5051 that is positioned along or within a groove in the cushion 5052, i.e., connects to the cushion with an interference or snap fit. The skeleton frame can have a headgear connection arm 5053 with a generally vertical post at the end to allow for a loop connection with the headgear straps. It may be preferable to make the skeleton frame out of a stiffer material than the cushion. Figure 3-35 shows a lower headgear connection 5054 that is positioned to snap or otherwise interface with the cushion 5055 just below or below the opening where the elbow is connected. 3-36(a) and 3-36(b) show a snap-fit ​​lower headgear connection assembly 5056, a variation of that shown in FIG. 3-21. FIG. 3-37 shows an elbow seal ring 5057 with associated headgear attachment arms 5058 that snap onto or otherwise interface with a frame 5059 and / or cushion 5060.

[0249] 3-38-3-49(b) show alternative configurations for connecting the headgear to the forehead support or the forehead support arm to the forehead support cushion. FIG. 3-38 shows a male buckle 5061 that can snap into a female buckle 5062 attached to the forehead support arm (push to release). The headgear can be looped or otherwise connected to the male buckle. Alternatively, the positions of the male and female buckles may be reversed. The buckles can be made from suitably rigid materials to allow for a snap fit, such as polycarbonate, polypropylene, nylon, etc. FIG. 3-39 shows a forehead support cushion 5063 with a slot or female connector 5063(1) that can engage or interface with a rod or male connector 5064(1) attached to the forehead support arm 5064. This configuration can allow for some horizontal rotation that may be preferred or desired by the patient. There can also be permanent or removable retention features for the connection of the male and female components. FIG. 3-40 shows an alternative buckle configuration with a male buckle 5061 and a female buckle 5062 to that shown in FIG. 3-38. FIG. 3-41 shows an alternative configuration of a male connector 5064(1) and a female connector 5063(1) to that shown in FIG. 3-39. FIG. 3-42 shows another alternative configuration of a male connector 5064(1) and a female connector 5063(1) to that shown in FIG. 3-39. FIG. 3-43 shows a forehead support cushion 5065 that attaches to the upper headgear strap. The forehead support cushion can have a slot or cavity 5065(1) that receives a T-shaped forehead support arm 5066. Such a configuration can allow for vertical rotation of the forehead support arm and therefore greater flexibility in adjusting the mask during use. 3-44(a) and 3-44(b) show a forehead support cushion 5067 with a slot 5067(1) that receives a sliding engagement with a forehead support arm 5068. The forehead support arm can slide vertically into the slot and a retention tab can be provided to prevent accidental disconnection of the connection. The forehead support arm can have a generally T-shaped cross-section that can prevent horizontal rotation of the forehead support arm when connected to the forehead support cushion.It may also act to strengthen the forehead support arm. FIG. 3-45 shows a forehead support cushion 5069 with a keyhole-shaped opening 5069(1) that can receive the forehead support arm 5070. The forehead support arm may be fitted with a generally circular disk 5070(1) whose end communicates with the opening in the forehead support cushion. Such a configuration may allow for horizontal rotation of the forehead support arm during use. FIG. 3-46(a) and FIG. 3-46(b) show a forehead support cushion 5071 that may have a generally C-shaped pocket 5071(1) that may capture a ball 5072(1) attached to the end of the forehead support arm 5072. FIG. 3-47 shows a two-part forehead support cushion including a first portion 5073(1) and a second portion 5073(2) that may be snapped around a generally cylindrical forehead support arm 5074. 3-48(a) and 3-48(b) show a two-part forehead support cushion that can have a first side 5075(1) that slidably engages a generally cylindrical forehead support arm 5076 and a second side 5075(2) that receives the end of the forehead support arm and the first side. FIG. 3-49(1) and 3-49(b) show a forehead support cushion 5077 that can have a two-part configuration, where each forehead support cushion is permanently or removably attached to an upper headgear strap. The forehead support cushion 5077 can also have an opening 5077(1) that receives a ball 5078(1) that is attached to the end of the forehead support arm 5078 for rotatable engagement with the forehead support arm. Alternatively, the ball / opening configuration can be reversed as shown in the associated cross-sectional view.

[0250] FIG. 3-50(a)-FIG. 3-69(b) show an alternative configuration for connecting the headgear to the forehead support without a buckle. FIG. 3-50(a)-FIG. 3-50(b) show an upper headgear strap 5079 that can be threaded through an opening in the forehead support 5080. Additionally, the opening can be provided with a lip or engagement tab 5080(1) on the outer or non-patient contacting side of the forehead support to keep the upper headgear strap in place. FIG. 3-51 shows an upper headgear strap 5079 that can be threaded through a forehead support 5080 with an engagement tab or hook 5080(1) to anchor the upper headgear strap within the forehead support. The forehead support can have an opening within which the upper headgear strap rests. FIG. 3-52(a)-FIG. 3-52(c) show a flexible forehead support 5081 that can flex vertically away from the patient's forehead to allow a wider range of fit. FIG. 3-53(a) and FIG. 3-53(b) show an upper headgear strap 5082 that can have two engagement arms 5083(1), 5083(2) that can be threaded through a forehead support 5083 to enclose and maintain the position of the upper headgear strap. These two arms can be generally C-shaped when viewed from the side. FIG. 3-54 shows an upper headgear strap 5084 that can be threaded through a generally Y-shaped forehead support 5085. A slot or gap can be provided at the top of the forehead support for separation of the headgear straps. FIG. 3-55 shows an upper headgear strap 5086 that can have a pocket or gap 5086(1) so that the forehead support 5087 can be inserted into a pocket in the upper headgear strap. FIG. 3-56 shows an upper headgear strap 5088 that can have a loop material 5088(1) on the outer or non-patient-contacting side. The forehead support 5089 can have a surface finish of hook material 5089(1) that can interface with the upper headgear strap, thereby engaging the forehead support with the upper headgear strap. FIG. 3-57 shows an upper headgear strap 5090 that can have a receptacle 5090(1) in its structure. The receptacle can be a gap in the fabric or an inserted reinforcement such as a small tube.The forehead support 5091 may be generally cylindrical and may be pushed or slid into a receptacle for engagement with the upper headgear strap of the forehead support. Fig. 3-58(a) and Fig. 3-58(b) show the forehead support 5092 with a hinge area 5092(1) that may wrap over the upper headgear strap 5093 and grip the upper headgear strap and hold it in a clamp. Fig. 3-59 shows the forehead support 5094 that may be ultrasonically welded to the upper headgear strap 5095. The forehead support may be permanently attached to the upper headgear strap by other suitable means such as gluing. Fig. 3-60 shows a two-part upper headgear strap 5096 in a baseball cap style that may pass through the forehead support 5097. Fig. 3-61 shows the upper headgear strap 5098 with a button or push pin 5098(1) that engages with a slot or receiving portion 5099(1) of the forehead support 5099. FIG. 3-62 shows an upper headgear strap 5101 with a cylindrical portion 5101(1) that can engage with a forehead support 5102, which can be shaped like a cradle or hook, so that the forehead support anchors over the cylindrical portion of the upper headgear strap. FIG. 3-63 shows an upper headgear strap 5103 with a cylindrical portion 5103(1) that can engage with a Y-shaped forehead support 5104. The Y-shaped forehead support can wrap around the cylindrical region of the upper headgear strap and can have pins adapted to engage within respective openings in the cylindrical region. FIG. 3-64 shows an upper headgear strap 5105 with the end regions at each end of the upper headgear strap folded into a T-shape. This T-shaped fold 5105(1) can then be slid into a buckle or receiving portion 5106(1) attached to the forehead support 5106. FIG. 3-65 shows an upper headgear strap 5107 with a two-part sliding adjustment channel that can have an opening or hole 5107(1) that receives a protrusion 5108(1) on the forehead support 5108. 3-66(a) and 3-66(b) show an upper headgear strap 5109 that can slide or otherwise engage within a groove 5110(1) formed in the top of the forehead support 5110. Alternatively, the forehead support 5111 can slide or otherwise engage within a receiving groove in the end of the headgear 5112. FIG. 3-67 shows a forehead support 5113 attached to an upper headgear strap 5114, with the arm of the forehead support having a portion that is snapped or otherwise attached onto the frame 5115. FIG. 3-68 shows a forehead support 5116 sewn into a loop at the end of the upper headgear strap 5117, with the forehead support snapped or otherwise connected to the frame 5118. FIG. 3-69(a) and 3-69(b) show a forehead support with a detachable arm 5119. In one embodiment, the arm can be connected to an elastic strap 5120.

[0251] Figures 3-70(a)-3-76 show alternative embodiments of buckle configurations used to attach the upper headgear connector to the headgear straps. Preferably, the buckles (shown in Figures 3-70(a)-3-76) are adapted to form a ladder-type locking clip. In these examples, the headgear straps are woven into a first opening and a second opening in the buckle. The openings are adapted to be parallel and generally aligned with the orientation of the straps to be received. By weaving the straps through this series of openings, the straps can be secured or locked in place to prevent or limit slippage. The straps can also have a undulating or corrugated surface that promotes better engagement with the buckle. Additionally, Figures 3-70(a) and 3-70(b) show an example of a buckle 5130 in which a series of parallel openings (also called ladder locks) have a series of teeth or corrugations 5131 at the extended end of the buckle. In one example, the extension end is twisted away from the horizontal plane to allow or facilitate better access by the patient's fingers, which may need to separate the buckle when the strap is secured. Figures 3-71(a) and 3-71(b) show a further example of a buckle 5132, in which the length of the buckle is configured with a curved or arcuate shape (when viewed from the side). This also improves the user's ability to remove or engage the strap, depending on the situation. Figure 3-72 shows a further example of a buckle 5133 that can be used with any of the examples described above. This example of a buckle has a further set of teeth or engagement means 5134 arranged to make frictional contact with the strap when in use. These second set of teeth are generally aligned with the general orientation of the strap engagement. This second set of teeth is generally adapted to prevent or limit slippage of the strap when engaged. FIG. 3-73 shows a series of openings referenced in FIGS. 3-70(a) and 3-70(b), 3-71(a) and 3-71(b), and 3-72 joined together to form a single opening 5136. FIG.The single opening is adapted to receive the strap and allow the strap to be woven around the buckle to prevent or limit slippage. Additionally, the opening can be open or broken at the top surface to make it easier to thread or weave the strap. Figures 3-74(a) and 3-74(b) show a further example of a buckle 5137, in which the buckle is ultrasonically welded to one end of a headgear strap 5138. The other end of this strap or another strap can be threaded or woven into the opening of this buckle. It should be noted that other means of fastening the buckle to the end of the strap, including friction locking, gluing or other types of suitable welding, can achieve the same or similar results. Figures 3-75(a) and 3-75(b) show a further buckle 5139, in which the portion 5139(1) of the buckle located between the two openings is slightly raised. The raised center feature of the buckle can further prevent or limit slippage by increasing the frictional force exerted on the strap 5140 during use. FIG. 3-76 shows a further buckle 5141, in which the buckle is attached to an end of a first strap 5142(1) through a first set of two openings. The first strap is woven through the first set of openings and looped back over itself. The first strap can then be secured to itself by stitching. The buckle also has a second set of two openings located at the opposite end, which can be used to engage a second strap 5142(2). In one example, the second set of openings is adapted to releasably secure the second strap, while the first set of openings is relatively more permanent, generally preventing the first strap from being released.

[0252] FIG. 3-77 shows headgear with rear strap loops 5143(1), upper straps 5143(2) that extend from the top of the rear strap loops, and lower strap loops 5143(3) that wrap around the mask and the bottom of the rear strap loops. The length of the lower strap loop can be adjusted by a spring loaded clip 5144. FIG. 3-78 shows an adjustment mechanism with a mushroom connector 5145 on the mask adapted to engage with a hole 5146(1) in a headgear clip 5146 for a headgear strap. FIG. 3-79 shows an adjustment mechanism with a ladder lock buckle 5147 on the mask that allows a headgear strap 5148 to form a loop therein.

[0253] FIG. 6-1 to FIG. 6-12(b) show headgear connection configurations (e.g., buckle clip designs) according to alternative examples of the present invention. FIG. 6-1 shows an outrigger-type clip 5150 having a narrow configuration with clip arms 5150(1) adapted to be pushed along the sides to release. The neck of the clip may be flexible. FIG. 6-2 shows an outrigger-type clip 5151 having clip arms 5151(1) adapted to be pushed down from the top to release. The neck of the clip may be flexible. The clip provides a relatively flat, low-profile design. FIG. 6-3 shows a continuous clip 5152 with a flexible neck. The clip has clip arms 5152(1) adapted to be pushed along the sides to release. The clip does not have a gap to be pushed into the clip receptacle. FIG. 6-4 shows a clip 5153 with a hook-like attachment portion 5153(1) adapted to engage with a bar-like receptacle of the frame. FIG. 6-5 shows a clip 5154 with a flexible neck ball or tapper lead-in 5154(1) and clip arms 5154(2) adapted to be pushed along the side to release. FIG. 6-6 shows a T-bar clip 5155 adapted to engage a hook-like receptacle 5156. The neck of the clip may be flexible. FIG. 6-7 shows a ball-in-socket configuration, in which a ball 5157(1) on the end of an outrigger 5157 is adapted to engage, for example, by a snap fit, with a c-cup receptacle 5158 provided on the frame. In one embodiment, the receptacle (e.g., plastic) may be constructed of a harder material than the ball (e.g., silicone) of the socket arrangement. FIGURE 6-8 shows a loop-over configuration in which an opening 5159(1) at the end of an outrigger 5159 is adapted to engage a rod-shaped receptacle 5160 with an enlarged head 5160(1). FIGURE 6-9 shows further details and alternatives to the clip 5151 shown in FIGURE 6-2 above, such as a receptacle 5161 on a frame that receives the clip.6-10(a) and 6-10(b) show a configuration where the frame has a release mechanism 5162 and the outrigger 5163 has a ball and clasp detail 5163(1) for retention. Strap tension can be used for release. FIG. 6-11 shows further details and alternatives to the clip 5152 shown in FIG. 6-3 above. FIG. 6-12(a) and 6-12(b) show a configuration where the frame has a flexible receptacle 5164 and the outrigger 5165 has a push button release 5165(1).

[0254] 6.1 Alternative Headgear As shown in Figures 14-1 and 14-2, the headgear 580 can have a two-color combination (e.g., blue and gray) that aids in ease of use in indicating which way the headgear should be oriented when fitting the mask (e.g., the two colors provide intuitive ease of use by indicating when the headgear is correctly aligned and where the hook and loop tabs are located). For example, the gray or a lighter color may be located on the inside of the headgear, so that when the headgear straps are threaded and folded over into the mask, the gray faces outward and is less visually intrusive on the face.

[0255] The headgear appears easy to use (inherent stability structure, two-color alignment instructions), appears comfortable (no visible hard stiffening parts, soft cloth finish, "soft" gray), appears unobtrusive (soft neutral gray, gray that coordinates with the metal and silicone color of the system), offers a high-quality look and feel of increased value (two-color, high-quality heat transfer branding, new manufacturing methods), appears unique (departure from traditional breathe-0-prene style, high-quality edge treatment, gray helps accentuate branding), and offers organization.

[0256] 18-1-18-2 and 19-1-19-2 show alternative configurations for threading the headgear straps around the patient's head in use, such as upper side straps 5560 that pass over the ears and lower side straps 5570 that pass below the ears.

[0257] Although the present invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it should be understood that the present invention is not limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements falling within the spirit and scope of the present invention. Also, the various embodiments described above may be implemented in connection with other embodiments, for example, aspects of one embodiment may be combined with aspects of another embodiment to embody yet another embodiment. Moreover, each independent feature or component of any given assembly may constitute a further embodiment. Moreover, although the present invention has been specifically adapted for patients suffering from OSA, it should be understood that patients suffering from other diseases (e.g., heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) may benefit from the above teachings. Moreover, the above teachings are applicable to patients and non-patients alike in non-medical applications. [Explanation of symbols]

[0258] 20 Frames 22 Main unit 24 Center opening 26 Side wall 30 forehead support 34 Headgear Connector 36 Lower Headgear Connector 40 Sealing mechanism 42 Cushion 44 Under Cushion 46 Membrane 50 protrusions 70 Elbow 72 First end 74 Second End 75 Vent mechanism 90 Swivel Ring 241 Foam Cushion 242 Cushion (Silicone Cushion) 244 Under Cushion 246 Membrane 247 Side wall 250 protrusions 430 Forehead support 434 Upper Headgear Connector 436 Lower Headgear Connector 450 protrusion 530 Forehead support 532 Side wall 536 Lower Headgear Connector 536(4) Connection part 536-1 Hook-shaped connector 540 Cushion 540-1 Cushion 544 Under Cushion 546 Membrane 550 protrusion 570 Elbow 570(1) Cushion connection end 570(2) Pipe connection end 573 Flexible fingers 590 Ring 1080 Headgear Straps 2010 Cushion 2040 Membrane 2043 Side flap 2090 Bent ring (swivel ring) 2400 Forehead Support Arm 2520 Lower Headgear Connector 2525 Connection 2530 Forehead support pad 2535 Upper Headgear Connector 3000 Elbow 3010 First Part 3020 Second Part 3100 Button 4000 Vents 4100 stem 4200 Vent Array 4250 Branch 4200 Array 4250 Vent 4500 Cushion 5003 Rear Strap 5004 Lower Headgear Strap 5018 Headgear Strap 5022 Headgear Straps 5024 Headgear Straps 5052 Cushion 5054 Lower headgear connection 5055 Cushion 5060 Cushion 5063 Cushion 5065 Cushion 5067 Cushion 5069 Forehead support cushion 5066 Forehead Support Arm 5068 Forehead Support Arm 5070 Forehead Support Arm 5072 Forehead Support Arm 5074 Forehead Support Arm 5076 Forehead Support Arm 5078 Forehead Support Arm 5079 Upper headgear strap 5071 Forehead support cushion 5077 Forehead support cushion 5080 Forehead support 5081 Forehead support 5082 Upper headgear strap 5083 Forehead support 5084 Upper headgear strap 5085 Forehead support 5086 Upper headgear strap 5087 Forehead support 5088 Upper headgear strap 5089 Forehead support 5090 Upper headgear strap 5091 Forehead support 5092 Forehead support 5093 Upper headgear strap 5094 Forehead support 5095 Upper headgear strap 5096 Upper headgear strap 5097 Forehead support 5098 Upper headgear strap 5099 Forehead support 5101 Upper headgear strap 5102 Forehead support 5103 Upper headgear strap 5104 Forehead support 5105 Upper headgear strap 5106 Forehead support 5107 Upper headgear strap 5108 Forehead support 5109 Upper headgear strap 5110 Forehead support 5111 Forehead support 5113 Forehead support 5114 Upper headgear strap 5117 Upper headgear strap 5138 Headgear Strap 5148 Headgear Strap 6000 Elbow 6050 Vent 6052 Vent 6054 Vent 6140 Forehead support cushion 6150 Vent 6152 Vent 6540 Cushion 6544 Under Cushion 6545 Flap 6546 Membrane (Facial flap) 6546(1) Bead 6640 Cushion 6670 Elbow BP bending point UL upper lip area SN Lateral region of the nose NB nasal bridge area CN corner area

Claims

1. 1. A mask system for delivering positive air pressure to a patient for the treatment of sleep disordered breathing, comprising: a sealing mechanism configured to form a seal with a patient's face during use, the sealing mechanism comprising a silicone cushion configured to sealingly engage the patient's face during use; a frame configured to interface with the sealing mechanism to support the sealing mechanism in an operative position against a patient's face during use, the frame comprising polycarbonate and being harder than the silicone of the cushion; Equipped with The frame is a body configured to connect with the sealing mechanism; a forehead support arm extending from the body; a forehead support pad mounted to the forehead support arm and configured to support the frame against a patient's forehead in use, the forehead support pad including a pair of upper headgear connectors for engaging a pair of upper side straps; the upper headgear connector including a pair of receiving holes formed in the forehead support pad for receiving the pair of upper side straps, the upper headgear connector having no slots extending into the receiving holes; a pair of lower headgear connectors integrally formed with a body of the frame, each lower headgear connector being connected to the body at a lower end of the headgear connector, and an upper end of each lower headgear connector being spaced from the body of the frame by a first gap disposed between the upper end and the body to allow a lower strap to be inserted therebetween; headgear comprising a pair of lower side straps removably connectable to the lower headgear connectors, the length of each lower side strap being adjustable by overlapping ends of the lower side straps along their length to form a headgear strap loop; Including, A mask system, wherein each lower headgear connector is aligned near the frame, in use, such that when the headgear strap loop is inserted vertically into the lower headgear connector by sliding a headgear strap along a first gap between an upper end of the lower headgear connector and a body of the frame to attach the headgear strap loop to the lower headgear connector, the lower headgear connector and the frame are configured such that the headgear strap loop of a corresponding lower side strap contacts it and slides along the side of the frame.

2. The mask system of claim 1 , wherein the forehead support arm is non-adjustably fixed to the body of the frame.

3. 3. The mask system of claim 1 or 2, wherein the forehead support arm is integrally formed with a body of the frame.

4. 4. The mask system of claim 1, wherein the forehead support pad comprises silicone.

5. the forehead support pad includes a first region and a second region; The mask system according to claim 1 , wherein the second region has a higher flexibility than the first region.

6. The mask system of claim 5 , wherein the first region comprises polycarbonate.

7. The mask system of claim 5 or 6, wherein the second region comprises silicone.

8. the headgear further comprises a pair of upper side straps removably connectable to the upper headgear connector; 8. The mask system of claim 5, wherein the second region of the forehead support pad is configured such that, in use, tightening the upper side strap causes a bent portion of the second region to expand outward against a spring force of the bent portion, thereby drawing the forehead support pad closer to the patient's forehead.

9. 9. The mask system of claim 1, wherein the lower headgear connector is hook-shaped.

10. 9. The mask system of claim 1, wherein the lower headgear connector is C-shaped.

11. When the mask system is worn by the patient during use, each lower headgear connector: 1) a radially outward extending portion connected to a body of the frame and extending radially outward therefrom; 2) a vertically extending portion connected to the radially outer extending portion and extending vertically therefrom; 3) a radially inner extending portion connected to the vertically extending portion and extending radially inward therefrom toward the body; Including, the radially inwardly extending portion terminates at an upper end of the lower headgear connector; the vertically extending portion of each lower headgear connector is spaced from the body by a second gap disposed between the vertically extending portion and the body; 11. The mask system of claim 1, wherein the first gap is smaller than the second gap at one or more locations along the length of the vertically extending portion.

12. The mask system of claim 11 , wherein the radially outwardly extending portion extends from a bottom wall of the body.

13. the body of the frame and the lower headgear connector are arranged such that, when the headgear strap loop is inserted into the lower headgear connector, the headgear strap loop is disposed in a space bounded by a curved portion of the body and an elongated portion of the lower headgear connector; the elongated portion of the lower headgear connector is the vertically extending portion; 13. The mask system of claim 11 or 12, wherein the second gap distance varies along the length of the vertically extending portion.

14. Each lower headgear connector includes a straight portion and a curved portion; 14. The mask system of claim 1, wherein the curved portion terminates at an upper end of the lower headgear connector.

15. a lower end of each lower headgear connector is connected to a body of the frame at a connection region; 15. The mask system of any one of claims 1 to 14, wherein the connection region is configured to allow the lower headgear connector to flex relative to the body to allow some freedom of movement of the lower headgear connector.

16. 16. The mask system of any one of claims 1 to 15, wherein the cushion is configured to seal against the nasal bridge region of the patient's face during use.

17. 17. The mask system of claim 16, wherein the cushion is a full face cushion.

18. The cushion is a face-contacting side including a membrane configured to sealingly engage the patient's face during use; a non-face-contacting side including an interface structure configured to removably connect to the frame; 18. The mask system of claim 1 , comprising:

19. 19. The mask system of any one of claims 1 to 18, further comprising an elbow having a first end and a second end, the second end configured to be connected to an air delivery tube.

20. 20. The mask system of claim 19, wherein the cushion includes a face-contacting side including an opening configured to be in fluid communication with the elbow for receiving a supply of breathable gas.

21. 21. The mask system of any one of claims 1 to 20, wherein the frame includes a vent with a plurality of holes for washing out gas.

22. 22. The mask system of any one of claims 1 to 21, wherein the headgear is configured for a four-point removable connection to the lower headgear connector and the upper headgear connector.

23. 23. The mask system of claim 22, wherein the headgear further comprises a pair of upper side straps removably connectable to the upper headgear connector.

24. 24. The mask system of claim 23, wherein, in use, the lower side straps are configured to pass under the patient's ears and the upper side straps are configured to pass over the patient's ears.

25. the upper side straps include hook and loop material that allows the upper side straps to be length adjustable; 25. The mask system of claim 23 or 24, wherein the lower straps include a hook and loop material that allows overlapping ends of each lower strap to be attached along a length of the lower strap to form the headgear strap loop.

26. the body comprises polycarbonate; 26. The mask system of any one of claims 1 to 25, wherein the pair of lower headgear connectors comprises polycarbonate.

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