breathing apparatus

Abstract

To provide a mask that seals well against a user's face without causing significant discomfort. [Solution] The mask frame has a central conduit connection aperture and lateral arms with a three-dimensional curvature, extending outward from the center of the frame and posteriorly toward the patient's ears. The lower margin of each lateral arm end, which is "twisted" along its length, is positioned farther from a vertical plane passing through the center of the conduit connection aperture than the upper margin. An anti-rotation mechanism is also provided to limit or prevent rotation between the headgear straps and the mask. The buckle for the closed-loop headgear has multiple openings and posts that form headgear strap passages through which the headgear strap loops can pass. The buckle also has friction loop openings through which the headgear strap loops can pass, with the angle of the angled passage allowing additional portions of the headgear strap loops to frictionally engage the friction loop openings.

Description

Technical Field

[0001] Incorporation by reference of all priority applications This application claims priority to U.S. Patent Application No. 62 / 077,071, filed Jul. 11, 2014, and U.S. Patent Application No. 62 / 212,431, filed Aug. 31, 2015, the entire contents of both of which are incorporated herein by reference.

[0002] Technical Field The subject invention of the present disclosure generally relates to an interface for supplying pressurized gas to a recipient.

Background Art

[0003] Respiratory gas can be delivered to a user in a variety of different mask styles and for a variety of different purposes. For example, a user can be ventilated using non-invasive ventilation (NIV). Additionally, a mask can be used to deliver continuous positive airway pressure therapy (CPAP) or variable airway pressure to treat medical conditions such as obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or congestive heart failure (CHF).

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

Summary of the Invention

Problems to be Solved by the Invention

[0005] Typically, patient interface devices include a mask frame that supports a sealing member. The sealing member comes into contact with the user's face, including the nose and nostrils, and the area surrounding the nose. Since these masks are usually worn for extended periods, various issues must be considered. For example, to provide CPAP for the treatment of OSA, users typically wear the mask overnight while sleeping. One issue in this situation is that the mask must be as comfortable as possible. It is also important that the mask provides a sufficient seal to the user's face without significant discomfort. [Means for solving the problem]

[0006] According to a first aspect of the present invention, a mask frame for a patient mask that delivers respiratory gas to a patient is provided, the mask frame is A central region comprising a conduit connection aperture configured to be connected to a respiratory gas delivery conduit, wherein a conceptual central vertical plane extends through the center of the conduit connection aperture, A first transverse arm and a second transverse arm, each extending outward from the central region in a direction away from the central vertical plane, Equipped with, Each lateral arm has a certain length, terminates at a distal end far from the central region, and each lateral arm has an upper margin and a lower margin. Each lateral arm twists along its length, thereby positioning the lower margin at the end of each lateral arm further away from the conceptual central vertical plane than the upper margin at the end of each lateral arm.

[0007] The lateral arm is, From the central area of ​​the frame, outwards horizontally, Towards the patient's ear, and The lateral arm is tilted upward, so as to extend upward along the direction from the end of the lateral arm to the area between the user's temple and ear. It can extend. The lateral arm can extend upward along a vector that runs from below the nose to the area between the temporal bones at the top of the ear.

[0008] Each lateral arm may comprise a planar, generally rectangular strip or band, with the ends of each strip defining upper and lower corners at the upper and lower margins, respectively, and the lateral arms twist along their length, so that the lower corners of the ends of the lateral arms are positioned further from the central region of the frame than the upper corners.

[0009] Each lateral arm can be tapered along its length, meaning that the distance between the upper and lower margins is reduced along at least a portion of the length of each lateral arm.

[0010] The end of the lateral arm can be positioned below a conceptual horizontal midplane that passes through the center of the elbow connection aperture.

[0011] The end of each arm may be equipped with a headgear connector configured to connect the frame to the headgear. The headgear connector may be equipped with a loop and post configured to provide a connection point for the hook of a headgear clip attached to the headgear.

[0012] In some embodiments, the headgear connector may include a rotation limiting structure configured to limit the relative rotation between the headgear and the mask frame connected to the headgear connector. The rotation limiting structure may include end fasteners against which the headgear abuts after a predetermined amount of relative rotation between the mask frame and the headgear. The rotation limiting structure may be provided on a post. The rotation limiting structure may include two spaced-apart end fasteners, and the relative motion between the headgear and the mask frame is limited by the distance between the two spaced-apart end fasteners.

[0013] According to another aspect of the present invention, a mask assembly is provided comprising a mask frame of the first aspect, further comprising a headgear configured to be connected to a lateral arm of the mask frame, and a sealing cushion configured to be attached to the mask frame.

[0014] A further aspect of the present invention provides a mask assembly comprising a mask frame and a headgear configured to be connected to the mask frame, wherein at least one of the mask frame and the headgear comprises a connector comprising a post, and the other of the mask frame and the headgear comprises a connector comprising a hook, the hook being configured to accept the post so as to connect the headgear to the mask frame such that the hook can rotate about the post toward and toward the mask frame, and the mask assembly further comprises at least one rotation limiting structure configured to limit the range of relative rotation between the hook and the post.

[0015] The rotation limiting structure may be equipped with an end stopper on either the mask frame or the headgear, so that the other of the mask frame or headgear contacts the end stopper after a predetermined amount of relative rotation between the mask frame and the headgear. Two end stoppers may be provided, one on the mask frame and the other on the headgear, and the end stoppers are configured to contact each other after a predetermined amount of relative rotation between the mask frame and the headgear. One end stopper may be provided on a hook, and the other end stopper may be provided on a post.

[0016] At least one of the hook and post may be provided with two spaced end fasteners, and the relative movement between the hook and post is limited by the distance between the two spaced end fasteners. One of the end fasteners may have a projection that protrudes from one of the hook and post, and the other of the hook and post may have a groove or recess having opposing ends, the opposing ends forming two spaced end fasteners, and the projection is configured to be received in the groove or recess when the headgear is connected to the mask frame, and to move between the opposing ends within the groove or recess. The groove or recess may be provided in the post, and the projection may be provided in the hook.

[0017] According to another aspect of the present invention, a headgear connector assembly is provided for connecting a headgear to a mask, the headgear connector assembly comprising a first connector having a post and a second connector having a hook, the hook being configured to accept the post so as to connect the first connector to the second connector, the hook being able to rotate about the post, and the headgear connector assembly further comprising at least one rotation limiting structure configured to limit the range of relative rotation between the hook and the post.

[0018] According to a further aspect of the present invention, a mask assembly is provided comprising a mask frame and a headgear configured to be connected to the mask frame, wherein the mask frame is A central region comprising a conduit connection aperture configured to be connected to a respiratory gas delivery conduit, wherein a conceptual central vertical plane extends through the center of the conduit connection aperture, A first transverse arm and a second transverse arm, each extending outward from the central region in a direction away from the central vertical plane, Equipped with, Each lateral arm has a certain length, terminates at a distal end far from the central region, and each lateral arm has an upper margin and a lower margin. Each lateral arm is twisted along its length, such that the lower margin at the end of each lateral arm is disposed further away from the conceptual central vertical plane than the upper margin at the end of each lateral arm. The headgear comprises a strap having a headgear connector configured to be rotatably connected to the end of the lateral arm. The mask assembly further comprises at least one rotation limiting structure configured to limit the range of relative rotation between the mask frame and the headgear.

[0019] According to a further aspect of the present invention, a buckle for a closed-loop headgear is provided, the buckle comprising an inner surface and an outer surface extending between a bottom surface and an upper surface, inner posts, a central post and outer posts each extending between the upper surface and the bottom surface, a friction loop opening disposed between the inner post and the central post and configured to receive a portion of the headgear strap loop, a front opening formed at least on the inner surface, an outer opening formed at least on the outer surface, a headgear strap passage extending between the front opening and the outer opening between the outer post and the central post and configured to receive the return portion of the headgear strap loop, and}3<} The front opening and the outer opening are offset such that the headgear strap passage is inclined.

[0020] The buckle may further comprise a strap attachment surface located on the inner surface of the outer post along the headgear strap passage, the strap attachment surface being configured to be attached to the strap of the headgear.

[0021] The front opening may be formed adjacent to the bottom surface of the buckle, whereby the front opening extends through both the bottom surface and the inner surface.

[0022] The outer opening can be formed at a distance from the bottom surface, along the outer surface.

[0023] The friction loop opening may have an upper margin and a lower margin, at least one of which is configured to frictionally engage with the headgear strap loop due to the angle of the return portion of the headgear strap passing through the inclined passage.

[0024] According to a further aspect of the present invention, a closed-loop headgear, The buckle according to the above-described aspect of the present invention, The rear headgear section, A closed-loop headgear is provided, comprising at least one strap extending forward from a rear headgear portion, the strap passing through a friction loop opening between an inner post and a central post.

[0025] Preferably, the strap then passes through the hook connector of the headgear, folds back to form the return portion of the headgear, and returns through the inclined headgear strap passage.

[0026] The strap may include a grip strap end extending from the outer opening through a buckle. The grip strap end may be long enough to be grasped between the thumb and one or two fingers. A recess for further gripping may be provided at the distal end of the grip strap end.

[0027] The rear headgear section may be equipped with a bifurcated rear section.

[0028] According to a further aspect of the present invention, an elbow is provided for connecting a respiratory gas delivery conduit to a patient mask assembly, the elbow being, The ball joint section and the bottom section, A long, slender tube section that connects the ball joint and the bottom, Equipped with, The elongated tube section is narrower in width than the maximum diameter of the bottom and ball joint sections.

[0029] The elongated tube portion may include a front portion configured to face away from the user during use and a back portion configured to face toward the user during use, with the front portion being longer than the back portion.

[0030] The elongated tube section can form a truncated top, where the front and back sections connect to the ball joint section.

[0031] The elongated tube portion can form an elbow with an angle θ between the longitudinal axis of the elongated tube portion and the longitudinal axis of the ball joint portion.

[0032] The front portion of the elongated tube section may include multiple bias holes configured to allow CO2 washout during use. The multiple bias holes may be arranged in columns along the length of the front portion, and in one embodiment, the multiple bias holes are arranged in two arrays of two columns with space between the two arrays. The columns within each section may be offset so that the bias holes in each row are nested with respect to each other, i.e., the bias holes in one column are at least partially positioned in the space between the bias holes in adjacent columns. One column may have a different number of bias holes than another column.

[0033] The elongated tube sections may each include side sections having notches. The notches can be configured to accommodate features of the diffuser body having a corresponding shape.

[0034] In other aspects of the present invention, the following are provided:

[0035] A: A device that is illustrated and described in diagrams.

[0036] B: A mask frame with lateral arms having three-dimensional curvature. The lateral arms can extend outward from the center of the frame, backward toward the patient's ears, and upward along a vector that runs from below the nose to a point between the temporal region and the top of the ear. The lateral arms can twist along their length, thereby positioning the lower corners of the ends of the lateral arms further away from the central portion of the frame than the upper corners.

[0037] C: The ball portion and the wide base, A long, narrow tube section connects the ball section and the wide base section, Equipped with, An elbow in which the elongated tube portion is narrower than the wide base and the maximum diameter of the ball portion. The elongated tube portion may include a long front portion (facing away from the user and mask during use) and a short back portion (facing towards the user and mask during use). The elongated tube portion may form a truncated top, where the long front portion and the short back portion connect to the ball portion. The elongated tube portion generally forms an elbow with an angle θ. The long front portion of the elongated tube portion may include multiple bias holes for CO2 washout during use. The multiple bias holes may be arranged in rows along the length of the long front portion. The multiple bias holes may be arranged in two portions of two rows, with space between the two portions. The rows within each portion may be offset, thereby causing the bias holes in each row to nest relative to one another. The elongated tube portion may include side portions, each having a notch. The notches may be configured to accommodate the corresponding shape of the diffuser body.

[0038] D. A buckle for closed-loop headgear, The bottom surface and the top surface, Each of the following extends between the top and bottom surfaces: an inner post, a central post, and an outer post, and a friction loop opening between the inner post and the central post, A passageway between the outer post and the central post, having a front opening and an outer opening, Equipped with, The front opening and the outer side are offset to form an inclined passageway. A strap attachment surface can be positioned inside the outer passageway.

[0039] E: A closed-loop headgear comprising a buckle according to the above embodiment D, A closed-loop headgear can be provided, with at least one strap extending forward from the rear portion passing through a buckle between an inner post and a center post. The strap then passes through a hook connector, folds back, and returns through the center and outer posts of the buckle. The strap may include a grip strap end extending from an outer opening through the buckle. The grip strap end may be long enough to be grasped between the thumb and one or more fingers. A recess for further gripping may be provided at the distal end of the grip strap end. The rear portion may be a bifurcated rear.

[0040] Various features, embodiments, and advantages of the present invention can be implemented in any of the various methods. For example, although several embodiments are described herein, a set or subset of features from any of the embodiments can be used together with a set or subset of features from any of the other embodiments.

[0041] The term “comprising” is used herein and in the claims to mean “at least partly composed of.” When interpreting a sentence containing “comprising” herein and in the claims, other features may also exist besides the feature preceding the term. Related terms such as “comprise” and “comprises” should be interpreted similarly.

[0042] Where references are made herein to patent applications, other external documents, or other sources, these are generally intended to provide context for considering the features of the present invention. Unless otherwise specified, references to such external documents should not be construed as accepting that such documents or sources constitute, in any capacity, prior art or form part of the common general knowledge in the art.

[0043] These and other features, embodiments, and advantages of the present invention will be described with reference to the following drawings. [Brief explanation of the drawing]

[0044] [Figure 1] This is a top front left perspective view of a non-limiting exemplary embodiment of a nasal breathing mask configured to provide a direct flow of pressurized breathing gas to the user's nostrils. [Figure 1a] Figure 1 is a front view of a flexible gas supply conduit, elbow assembly, and swivel assembly that can be used with the mask. [Figure 1b] Figure 1a is a side view of the flexible gas supply conduit, elbow assembly, and swivel assembly. [Figure 1c] Figures 1a and 1b are enlarged perspective views of the elbow assembly and flexible gas supply conduit. [Figure 2a] Figure 1 is a top front left perspective view of an exemplary, not-limiting embodiment of a sealing cushion that can be incorporated into a mask. [Figure 2b] Figure 2a is a perspective view of the bottom back right side of the sealing cushion. [Figure 3a] This is a top front left perspective view of an exemplary, not-limiting embodiment of a mask frame, comprising a proximal side, a distal side, a central region, and lateral arms extending from both sides of the central region, which can be incorporated into the mask of Figure 1 together with the sealing cushions of Figures 2a and 2b. [Figure 3b] Figure 3a is a perspective view of the bottom rear right side of the mask frame. [Figure 4]Figures 3a and 3b show orthogonal front views of the mask frame. [Figure 5] The corresponding orthogonal top views of the mask frames in Figures 3a and 3b are shown. [Figure 6] The corresponding orthogonal side views of the mask frames in Figures 3a and 3b are shown. [Figure 7] This is a side view of the breathing mask above user U during use. [Figure 8] The following are exemplary, non-limiting embodiments of an elbow that can be optionally incorporated into the mask of Figure 1, together with the sealing cushions of Figures 2a and 2b and the mask frames of Figures 3a and 3b. [Figure 8A-F] The following are exemplary, non-limiting embodiments of an elbow that can be optionally incorporated into the mask of Figure 1, together with the sealing cushions of Figures 2a and 2b and the mask frames of Figures 3a and 3b. [Figure 9A-D] Figures 8 and 8A to 8F show exemplary, non-limiting embodiments of a diffuser configured to connect to the elbows. [Figure 10A-E] Figures 8 and 8A to 8F show the elbow and diffuser assembly, where the diffuser is connected to the elbow so as to cover the bias holes. [Figure 11A-B] This shows an exemplary, non-limiting embodiment of a mask assembly with a closed-loop headgear. [Figure 12A-F] This shows a non-limiting exemplary embodiment of a buckle used in closed-loop headgear. [Figure 13A-B] This is an external perspective view of the buckle and strap used in closed-loop headgear. [Figure 14A-B] The headgear strap passes through the buckle in cross-section. [Figure 15A-B] This shows closed-loop headgears in sliding and friction modes. [Figure 16A-F] This shows a non-limiting exemplary embodiment of a headgear connector assembly for connecting headgear to a mask. [Modes for carrying out the invention]

[0045] As used herein, the term “holding force” refers to any force applied by the headgear to hold the breathing mask in place on the user’s face.

[0046] Figure 1 shows an exemplary, non-limiting embodiment of a nasal breathing mask 1 configured to deliver a flow of pressurized breathing gas directly into the user's nostrils. The breathing mask 1 comprises a sealing cushion 3, a mask frame 5, an elbow assembly 7, a flexible gas supply conduit 9, a swivel assembly 11, a headgear 13, and a pair of headgear clips 15.

[0047] Elbows and flexible gas supply conduits Referring to Figures 1a to 1c, the elbow assembly is configured to connect to the elbow connection aperture 77 of the mask frame 5 (see, for example, Figures 1 and 3a). The elbow assembly 7 includes a ball joint portion 21 and a wide base portion 23. An elongated tube portion 25 connects the ball joint portion 21 and the wide base portion 23. In this example, the elongated tube portion 25 is narrower than the maximum diameter of the wide base portion 23 and the ball joint portion 21. The elongated tube portion 25 includes a long front portion 27 (facing away from the user and the mask 1 when in use) and a short back portion 29 (facing towards the user and the mask frame 5 when in use). The elongated tube portion 25 forms a truncated top portion 31, where the long front portion 27 and the short back portion 29 connect to the ball joint portion 21. In this configuration, the elongated tube portion 25 generally forms an elbow with a bend along its length, thereby preventing the longitudinal axis of the conduit receiving portion to the elbow assembly 7 from aligning with the longitudinal direction of the ball joint portion 21.

[0048] The long front section 27 of the elongated tube section 25 contains a plurality of bias flow holes 35 for CO2 washout in use. The plurality of bias flow holes 35 are arranged in rows along the length of the long front section, and the rows are generally aligned with the longitudinal axis of the elongated tube section 25. In particular, in this example, the plurality of bias flow holes 35 are arranged in three central long rows and two lateral short rows, with space between the two sections. Each long central row has 12 bias flow holes in this example, and each short lateral row has 7 bias flow holes. These rows are located in the tapered keyhole region of the long front section 27.

[0049] The wide base 23 is a short tubular section that is concentrically offset from the conduit receiving section, thereby forming an annular channel between the two. The conduit receiving section is configured to receive the flexible gas supply conduit 9 on its outer surface. The annular channel is configured to receive and hold the end of the flexible gas supply conduit 9. The conduit receiving section includes a male thread configured to hold the flexible gas supply conduit 9. The wide base 23 is configured to conceal the end of the flexible gas supply conduit 9.

[0050] The flexible gas supply conduit 9 is a flexible tube comprising an external helical bead 41 and a thin conduit wall 43 supported by the bead 41. The bead 41 may include conductive wires or strips for providing heat to the conduit 9 or for transporting data or sensor signals along the conduit 9. The thin wall 43 has radially outward folds or bends 45 between each adjacent helical coil. These outward-facing folds 45 do not protrude as far outward as the bead 41, so that when the conduit 9 is in a neutral position, as shown in Figures 1a to 1c, the diameter of the folds is smaller than the diameter of the bead. The bead 41 and folds 45 are configured so that the conduit 9 is flexible, bendable, and can stretch or contract longitudinally. The folds 45 allow the conduit 9 to bend so that it is not straight when in use. The folds 45 also allow the length of the conduit 9 to be changed. The bead 41 can be configured as a spring so as to be resilient to any bending, stretching, or contraction of the conduit 9, and the bead 41 and / or fold return the conduit 9 to its neutral state when no force is applied to the end of the conduit 9.

[0051] Sealing cushion The sealing cushion 3 is configured to engage with the nostrils and outward-facing surfaces of the user's nose, and to form a substantially airtight seal, so that pressurized respiratory gas is delivered directly to the nasal passages. Such a seal is described in its entirety in PCT / NZ2014 / 000150, filed on 17 July 2014 (International Publication No. 2015009172), which is incorporated herein by reference.

[0052] The sealing cushion 3 preferably comprises a seal body 51 and a mask frame connector 53. The seal body 51 can be formed from a soft and flexible material, thereby providing a flexible pocket or cover that defines an internal cavity. The seal body 51 can be made from any suitable material, but is not limited to latex, vinyl, silicone, or polyurethane.

[0053] Referring to Figures 2a and 2b, the seal body 51 comprises a central portion 55 and first and second side portions 57 and second side portions 57 extending from each side of the central portion 55. The seal body 51 further comprises an inner portion 59 (Figure 2b) and an outer portion 61 (Figure 2a). The inner portion 59 is positioned proximal to the user's face during use and is configured to provide a sealing surface, a stabilizing surface, and a positioning surface. The outer portion 61 is positioned distal to the user's face relative to the inner portion 59 during use and is configured to provide structure to the sealing cushion 3.

[0054] The inner side 59 of the central portion 55 is configured to extend across the base of the user's nose, and the inner side of each lateral portion 57 is configured to curve around and extend across the sides of the nose. These lateral portions 57 can form a periphery seal on the surface facing the outside of the nose, i.e., the flank. The lateral portions 57 widen outward at the lower corners away from the user's nose, thereby making contact with the user's cheek without digging in. The contact between the lateral portions 57 and the user's cheek provides a place where the headgear 13 can apply a retaining force to the user's face in order to stabilize the breathing mask 1.

[0055] The inner part 59 has a thin wall thickness, thereby allowing the seal body 51 to be flexible and conform to the shape of the user's nose. The outer part 61 has a greater wall thickness than the inner part 59, thereby providing structure and stability to the more flexible inner part 59.

[0056] The inner part 59 of the central portion 55 further comprises a pair of prongs 62. The prongs 62 are provided with an air delivery opening 63 and a positioning surface 65. The air delivery opening 63 is configured to allow a flow of pressurized respiratory gas from within the seal body 51 into the user's airway. The positioning surface 65 is configured to position and seal the prongs 62 within the user's nostrils and to provide a means for positioning the sealing cushion 3 over the nose.

[0057] The mask frame connector 53 is located within the outer 61 of the central portion 55 and comprises a substantially rigid ring that is permanently attached to the seal body 51 by any suitable means. The mask frame connector 53 is configured to provide an inlet through which pressurized breathing air passes when delivered into the seal body 51. The mask frame connector 53 is further configured to provide a substantially airtight connection between the sealing cushion 3 and the mask frame 5, and the mask frame 5 and sealing cushion 3 can be repeatedly assembled and disassembled. The connection between the mask frame 5 and the mask frame connector 53 can be achieved by any suitable means, including, but not limited to, snap-fit, friction-fit, threaded, or bayonet mechanisms.

[0058] Mask frame As shown in Figures 3a and 3b, the mask frame 5 comprises a proximal side 71 (Figure 3b), a distal side 73 (Figure 3a), a central region 75, and first and second lateral arms 97 and second lateral arms 97 extending from each side of the central region 75. Each lateral arm 97 comprises a generally rectangular planar strip having elongated upper and lower margins extending along the length of each arm 97. Thus, the lateral arms 97 are relatively wide when viewed from the front but relatively narrow when viewed from above. The proximal side 71 is configured to be adjacent to the sealing cushion 3 and proximal to the user's face when in use. The distal side 73 forms the outer surface of the mask frame 5. The distal side 73 of the central region 75 comprises an elbow connection aperture 77 which may optionally be circular. The elbow connection aperture 77 is configured to receive the ball joint 21 of the elbow assembly 17. A planar surface 81 extends radially outward from the elbow connection aperture 77.

[0059] The proximal side 71 of the central region 75 is provided with an annular wall 83 that projects rearward toward the sealing cushion 3 around the elbow connection aperture 77.

[0060] The annular wall 83 comprises an inner surface 85 and an outer surface 87. The inner surface 85 includes a concave spherical portion configured to form a ball joint socket. The ball joint socket is configured to connect to the corresponding shape of the elbow assembly 17, i.e., the ball joint portion 21. The outer surface 87 includes one or more recesses 91 configured to connect to the corresponding shape of the mask frame connector 53 of the sealing cushion 3, thereby achieving a connection between the mask frame 5 and the cushion seal.

[0061] Figure 4 shows a orthogonal front view of the mask frame 5. This view is perpendicular to a front 80 that coincides with a planar surface 81 (see, for example, Figure 3a). The mask frame 5 is symmetrical with respect to a central vertical plane "y" passing through the center of the elbow connection aperture 77. The mask frame 5 further comprises an upper margin 93 and a lower margin 95, both extending from one lateral arm 97 through the central region 75 to the other lateral arm 97. The upper margin 93 is positioned above the lower margin 95 in the view of Figure 4 and in use. Within the central region 75, the upper margin 93 is offset from the elbow connection aperture 77 and substantially follows its curvature. The upper margin 93 tapers significantly downwards outwards (horizontally away from the central vertical plane "y") as it transitions from the central region 75 to each of the lateral arms 97. The lower edge margin 95 curves outward somewhat upward from the central vertical plane "y" region. It curves slightly downward as it transitions from the end of the central region 75 toward each end of the lateral arm 97.

[0062] The tapered transitions of the upper margin 93 and lower margin 95 form a lateral arm 97, which is a substantially elongated tapered member extending outward from each side of the central region 75. The lateral arm 97 comprises a loop 99 and a post 101 configured to provide a connection point for a headgear clip (see, for example, Figure 14A). The loop 99 is a rectangular aperture extending perpendicular to the distal plane through the lateral arm 97. In alternative embodiments, the aperture can have any suitable shape. The post 101 is formed by the outer wall of the loop 99, forms the outer end of the lateral arm 97, and is substantially cylindrical. The post 101 is inclined upward toward the central region 77, as indicated by the lower edge width w1 being wider than the upper edge width w2.

[0063] The end of the lateral arm 97 is positioned substantially below the horizontal intermediate plane "x", which is perpendicular to the front and vertical planes y and passes through the center of the elbow connection aperture 77. Thus, the lateral arm 97 is tapered toward the lower half of the mask frame 5.

[0064] Figure 5 shows the corresponding orthogonal top view of the mask frame 5. It shows that the lateral arm 97 also extends backward (distal to proximal) from the planar surface 81.

[0065] Figure 6 shows the corresponding orthogonal side view of the mask frame 5. It can be seen that the end of the lower margin 95 is closer to the front than the end of the upper margin 93. As a result, the length of post 101 forms an acute angle α with the front.

[0066] Figure 7 is a side view of the breathing mask 1 in use on user U. When user U is standing upright during use, the front is inclined. The angle of the post 101 (as described above with reference to Figure 6) is such that the holding force F applied by the headgear 13 is substantially perpendicular to the angle of the post 101. This minimizes the torsional force between the headgear 13 and the mask frame 5, and thus improves the stability of the breathing mask 1 on user U. The lateral arm 97 is inclined upward so as to extend along the direction extending from the end of the lateral arm 97 to the region between the user's temple and ear.

[0067] In other words, the lateral arm 97 has a three-dimensional curvature. When in use, the lateral arm 97 extends outward from the center of the frame 5, backward toward the patient's ear, and along a vector that runs from below the nose to the point between the temporal region and the top of the ear. Furthermore, the lateral arm 97 "twists" along its length, so that the lower corners of the ends of the lateral arm 97 are positioned further from the central vertical plane than the upper corners, for example, as shown in Figure 5.

[0068] By positioning the lateral arms 97 on the lower half of the mask frame 5, the stability of the breathing mask on the user's face is improved. The retaining force F applied by the headgear 13 to the mask frame 5 and sealing cushion 3 is mainly applied through the sides of the sealing cushion 3. This means that the retaining force is mainly applied to the user's nose, upper lip, and the underside of the cheeks. This increases the surface area over which the force can be distributed, thus improving stability. By distributing the force over a wider surface area, any pressure points on the user's face that could cause discomfort can be minimized. If the lateral arms 97 were positioned higher on the mask frame 5, the force vector F would be mainly applied to the tip of the user's nose, which could reduce the stability of the breathing mask 1. This could also cause discomfort to the user in the form of pressure points on the tip of the user's nose.

[0069] By positioning the lateral arms 97 downwards, the breathing mask 1 is given a more minimal appearance. The mask frame 5 is positioned substantially below the nose when in use, so it is less visible and therefore less conspicuous on the user's face. By positioning the lateral arms 97 downwards in combination with the angle of the post 99, the headgear 13 also passes over the user's cheeks at a greater distance from below the eyes. This is beneficial in that the headgear 13 is less likely to enter the user's peripheral vision, making the mask 1 less visually distracting and more comfortable to wear.

[0070] Elbows and diffusers Figures 8 and 8A to 8F show an elbow 117, similar to the elbow 17 described above, configured to connect to an elbow connection aperture 77 (see, for example, Figures 1 and 3a). The elbow 117 includes a ball joint portion 121 and a wide base portion 123. An elongated tube portion 125 connects the ball joint portion 121 and the wide base portion 123. The elongated tube portion 125 is narrower than the maximum diameter of the wide base portion 123 and the ball joint portion 121. The elongated tube portion 125 includes a long front portion 127 (facing away from the user and mask during use) and a short back portion 129 (facing towards the user and mask frame 5 during use). The elongated tube portion 125 forms a truncated top portion 131, where the long front portion 127 and the short back portion 129 connect to the ball joint portion 121. In this configuration, the elongated tube portion 125 generally forms an elbow having an angle Φ.

[0071] The elongated front portion 127 of the elongated tube portion 125 includes a plurality of bias flow holes 135 for CO2 washout in use. The plurality of bias flow holes 135 are arranged in columns along the length of the elongated front portion 127. In particular, as shown in the figure, the plurality of bias flow holes 135 are arranged in two portions or regions of two columns, with space between the two portions or regions of the elongated tube portion 125. The columns within each portion or region are offset, thereby the bias flow holes in each row are nested with respect to one another, i.e., the bias flow holes in one column are nested, at least partially, in the space between the bias flow holes in another column. The elongated tube portion 125 further includes side portions 137, each having a notch 139. The notch 139 is configured to receive a portion of the diffuser body having a corresponding shape.

[0072] The wide base 123 is a short tubular section that is concentrically offset from the conduit receiving section 141, thereby forming an annular channel 143 between the two. The conduit receiving section 141 is configured to receive the flexible gas supply conduit 9 on its outer surface. The annular channel 143 is configured to receive and hold the end of the flexible gas supply conduit 9. The conduit receiving section includes a retaining structure which may be a projection, which in this example is a thread 145, and is configured to hold the flexible gas supply conduit 9. The wide base 123 is configured to conceal the end of the flexible gas supply conduit 9. Thus, the end of the flexible conduit 9 is screwed onto the elbow 117 to hold the conduit 9 on the elbow 117.

[0073] Figures 9A to 9D show a diffuser 151 configured to connect to an elbow 117, which covers the bias flow hole 135 so that gases discharged from the bias flow hole 135 pass through the diffuser 151. The diffuser 151 comprises a diffuser body 153 and one or more regions of diffuser material 155. The diffuser body 151 comprises a substantially rigid plastic component having two sides 157 and a front region 159 between them. The diffuser body 153 is configured to have a curvature that complements the curvature of the elongated tubular portion 125 of the elbow 117, extending from one side portion across the front portion to the other side portion. The diffuser body 153 further comprises one or more diffuser openings 161 and a pair of grip tabs 163. The diffuser openings 161 are positioned in the front region 159 so as to partially overlap the bias flow hole 135 when in use. In this embodiment of the present disclosure, the diffuser opening 161 is separated by a grid member 165.

[0074] The grip tabs 163 extend approximately perpendicularly from each edge of the side 157 of the diffuser body 153 and have a substantially trapezoidal contour. They are configured to allow the user to grip the diffuser 151 between their thumb and index finger while removing it from the elbow 117.

[0075] The diffuser body 153 has an inner surface 167 that is configured to be proximal to the elongated tubular portion 125 of the elbow 117 when in use. The inner surface 167 is provided with a pair of engaging tabs 169. The engaging tabs 169 extend inward from each of the grip tabs 163 and are configured to engage with the notches 139 of the elbow 117, thereby holding the diffuser 151 on the elbow 117.

[0076] The area of ​​the diffuser material 155 is configured to fill the diffuser opening 161, providing a winding passage through which the discharged air passes. The diffuser material 155 can be any permeable or porous material. When in use, the diffuser material 155 is coplanar with the bias flow hole 135, thus ensuring that the air discharged from the bias flow hole 135 is diffused through the diffuser material 155.

[0077] Figures 10A to 10D show the elbow 117 and diffuser 151, where the diffuser 151 is connected to the elbow 117 so as to cover the bias flow holes 135. Because the elongated tubular portion 125 of the elbow 117 is narrow, the diffuser 151 can be configured to have a width substantially equal to the outer diameter of the wide bottom portion 123 of the elbow 117. Furthermore, the elongated tubular portion 125 of the elbow 117 allows for a longer row of bias flow holes 135, and thus the width of the elbow 117, and therefore the elbow 117 and diffuser 151 can be narrowed. This gives the elbow 117 and diffuser 151 assembly a smaller and less bulky appearance.

[0078] headgear As shown in Figures 1 and 7, the breathing mask 1 is secured to the user's head by a headgear 13. The headgear 13 has a three-part structure, in which the three parts include a pair of side straps 171 and a rear section 173. The side straps 171 are configured to be joined to the rear section 173 at one end and to the headgear clip 175 at the other end. The side straps 171 can be joined to the rear section 173 by any preferred means, including, but not limited to, ultrasonic welding, high-frequency welding, adhesive or suture. The ends of the side straps 171 that connect to the headgear clip 175 are provided with fixing tabs 177 for adjusting the headgear size. The fixing tabs 177 are provided with a hook element of a hook-loop connector, such as, but not limited to, Velcro®. The fixing tabs 177 are configured to be attached to the outer surface of the side straps 171 to fix the length of the side straps 171, and therefore the size of the headgear 13. The rear section 173 comprises a bifurcated component having an upper strap 173a and a lower strap 173b configured to engage with the occipital region of the user's head. The headgear 13 can be made of, but is not limited to, Neoprene, TPE, or Breathhoprene. TM Alternatively, it can be made from any suitable non-stretchable or stretchable material known in the art, including knitted fabrics or any combination of materials. In a preferred embodiment, the rear portion 173 and side straps 171 are made from a single material in contrasting colors. In an alternative embodiment, the rear portion 173 may be made from a different material than the side straps 171. In a further alternative embodiment, the rear portion 173 and side straps 171 may be monochromatic.

[0079] Closed-loop headgear Figures 11A and 11B show a perspective view and a top view, respectively, of a non-limiting exemplary embodiment of a mask assembly 1 with a closed-loop headgear 13. The mask assembly 1 is attached to the bifurcated headgear 13. A front strap 171 extends forward from a rear bifurcated portion 173. The front strap 171 passes through a buckle 179 and then through a hook 101 attached to the mask assembly 1. Each front strap 171 folds back and passes through the buckle 179.

[0080] The headgear 13 shown in Figures 11A and 11B is a closed-loop headgear, meaning that the length of the headgear can be adjusted from a minimum to a maximum length, but it cannot be completely removed. A closed-loop configuration may be desirable because the headgear 13 cannot be disassembled and therefore cannot be improperly reassembled. The headgear 13 can be made from any suitable non-stretchable or stretchable material known in the art, including, but not limited to, Neoprene, TPE, Breahoprene®, or knitted fabric.

[0081] Figures 12A to 12F show non-limiting exemplary embodiments of a buckle 179 used in a closed-loop headgear 13, as shown in Figures 11A and 11B. Figures 12A and 12B show the inside and outside views of the buckle 179, respectively. As shown, the buckle 179 includes a bottom surface 181 and a top surface 183. An inner post 185, a center post 187, and an outer post 189 extend from between the top surface 181 and the bottom surface 183. Between the inner post 185 and the center post 187 is a friction loop opening 191. Between the outer post 189 and the center post 187 is a passage with a front opening 193 and an outer opening 195. The front opening 193 and the outer opening 195 are offset to form an inclined passage. Furthermore, a strap attachment surface 197 is located inside the outer post 189.

[0082] Figures 12C and 12D show perspective cross-sections of the buckle 179, particularly highlighting its internal features. The central post 187 has a central post shoulder portion 199 and a central post recess 201.

[0083] Figures 12E and 12F show the front and rear views of the buckle, respectively, to illustrate in particular the features described above in more detail.

[0084] Figures 13A and 13B are external perspective views of the buckle 179 and strap 171 used in the closed-loop headgear 13. As shown, the strap 171, extending forward from the rear portion 173, passes through the buckle 179 between the inner post 185 and the center post 187. The strap 171 then passes through the hook (see, for example, Figure 11A), folds back, and returns through the center post 187 and the outer post 189 of the buckle 179. The strap 171 includes a grip strap end 205 that extends through the buckle 179. The grip strap end 205 is long enough to be grasped between the thumb and one or more fingers. A recess 207 is provided for further gripping.

[0085] Figures 14A and 14B show a cross-section of the strap 171 passing through the buckle 179, forming an adjustable closed loop 209. The strap 171 passes through a friction loop opening 191 formed between the inner post 185 and the center post 187. The strap 171 passes through the buckle 179 and returns through an inclined passage formed between the front opening 193 and the outer opening 195.

[0086] As shown in the figure, the buckle 179 is inclined relative to the strap 171. As a result of the angle at which the strap 171 passes through the friction loop opening 191, there is an interlocking corner 192 that generates a frictional force that limits the strap 171 from sliding when under tension. In particular, the plane of the strap 171 through which the strap 171 passes through the friction loop opening is inclined with respect to the plane of the buckle 179, so that the strap 171 is neither perpendicular nor parallel to the buckle 179.

[0087] The strap 171 is permanently attached to the buckle 179 at the strap attachment surface 211 (see, for example, Figure 12A) located inside the outer post 189. Because the strap 171 is permanently attached to the buckle 179, the headgear 13 cannot be disassembled (i.e., the hook of the adjustable closing loop cannot be removed). The strap 171 can be attached to the strap attachment surface 211 by any preferred means, including, but not limited to, ultrasonic welding, high-frequency welding, adhesive, or sutures.

[0088] Figures 15A and 15B show the closed-loop headgear 13 in sliding and friction modes, respectively. In Figure 15A, a tensile force 204 is applied to the grip strap end 205. This tensile force causes the buckle 179 to rotate in the direction of the tensile force (counterclockwise as shown in the figure) 206. The "rotated" buckle 179 is represented by a dashed rectangle in Figure 15A. The buckle 179 rotates due to the tensile force because the strap 171 is attached to the buckle 179 at the strap attachment surface 211. As the buckle 179 rotates, the buckle 179, particularly the friction loop opening 191, becomes more vertical as the strap 171 slides through the opening 191 208. As a result, the interference fit at the interference corner 192 (see, for example, Figure 14B), and therefore the friction force, is reduced. This allows the strap 171 to pass freely (or with at least less resistance) through the friction loop opening 191, and thus become adjustable.

[0089] Alternatively, as shown in Figure 15B, a tension 210 is applied, for example, when mask assembly 1 is in use. The tension 210 causes buckle 179 to rotate in the direction of the tension (clockwise as shown in the figure). As buckle 179 rotates, the buckle, and in particular the friction loop opening 191, becomes more inclined with respect to the strap 171 as it passes through the opening 191. The "rotated" buckle 179 is represented as a dashed rectangle in Figure 15B. As a result, the interference fit at the interference corner (see, for example, Figure 14B) increases, and therefore the frictional force between the friction loop opening 191 and the strap 171 passing through it increases.

[0090] Headgear connector assembly Referring to Figures 16A to 16F, the headgear 13 is connected to the mask frame 5 using a hook-post type headgear connector assembly 221. In one example, the mask frame 5 has posts 101 on each lateral arm 97. Each headgear clip 15 has a hook 15a configured to receive the respective post 101 of the mask frame 5 in order to connect the headgear 13 to the mask frame 5.

[0091] In one embodiment, each headgear clip 15 can rotate freely around each post 101 of the mask frame 5. The posts 101 are generally oriented vertically during normal use of the mask 1 and headgear 13, and therefore the side straps 171 rotate laterally around a generally vertical pivot axis. This may have the effect that, before the mask 1 and headgear 13 are placed on the user's head, the side straps 171 of the headgear 13 pivot around the posts 101 of the mask frame 5 to a position where a portion of the headgear 13 is adjacent to the mask 1 and therefore obstructs the mask 1 as it is positioned on the user's face. Therefore, the side straps 171 of the headgear 13 may rotate around the posts 101 of the mask frame 5, thereby obstructing the inside of the seal body 53. This may make the mask 1 and headgear 13 difficult or inconvenient to wear.

[0092] It may be desirable to prevent, limit, or control the range of relative rotational movement between the headgear 13 and the mask frame 5, and in particular to limit the range of rotation of the side straps 171 of the headgear 13 relative to the mask frame 5.

[0093] Referring further to Figures 16A to 16F, in one embodiment, the post 101 of the mask frame 5 and the hook 15a of the headgear clip 15 each have their own movement-restricting structures. These structures are arranged to engage to prevent relative rotational movement between the mask frame 5 and the headgear 13, and more specifically between the mask frame 5 and the side straps 171 of the headgear 13. Thus, the headgear connector assembly 221 between the mask 1 and the headgear 13 performs a rotation-restricting function to help prevent the side straps 171 of the headgear 13 from rotating relative to the mask frame 5 to a position that obstructs the mask 1, particularly to the inside of the seal body 53.

[0094] In one embodiment, each post 101 of the mask frame 5 has a recessed region with a reduced diameter compared to the rest of the post 101, forming a groove or recess 225 that extends particularly around the post 101 in a plane perpendicular to the axis of the post 101. Viewed from above, i.e., along the axis of the post 101, the groove or recess 225 extends around only a portion of the post 101, i.e., the groove or recess 225 is a partial circumference. The groove or recess 225 can extend, for example, through about 180°. Thus, the groove or recess 225 has two opposing ends 225a, 225b, where the groove or recess 225 contacts the non-recessed portion of the post 101. These ends 225a, 225b constitute a movement-restricting structure that forms an end stopper.

[0095] Each hook 15a also includes a movement-restricting mechanism, which, in one example, includes a projection or protrusion 227 on the inner surface of the hook 15a, i.e., on the portion of the hook 15a that receives the post 101 when in use, that functions as an end stopper. When the post 101 is received by the hook 15a (which may be using a snap-fit ​​connection), the projection 227 of the hook 15a moves within the groove or recess 225, causing relative rotation between the post 101 and the hook 15a. This allows the side strap 171 of the headgear 13 to pivot within a limited range around the post 101 of the mask frame 5. When the side strap 171 has rotated a predetermined distance relative to the mask frame 5, the projection 227 reaches one end of the groove or recess 225 and contacts the end stoppers 225a, 225b of the groove or recess, which prevents further relative rotation between the hook 15a and the post 101. Therefore, the protrusion 227 can move a predetermined distance along the groove or recess 225 before the protrusion 227 moves any further, thus preventing the side strap 171 from rotating relative to the mask frame 5.

[0096] In another embodiment, the hook 15a and post 101 may be reversed, with the hook 15a provided on the mask frame 5 and the post 101 on the headgear clip 15. Similarly, it is intended that a protrusion or projection 227 may be formed on the post 101, and a groove or recess 225 may be formed on the hook 15a.

[0097] A groove or recess 225 can be provided at any position along the length of the post 101, i.e., at any axial position of the post 101. Two or more grooves or recesses 225 and protrusions 227 can be provided. The length of the groove or recess 225 and / or the size of the protrusions 227 can be selected to achieve a desired relative rotation angle between the post 101 and the hook 15a.

[0098] In at least one embodiment, grooves or recesses 225 are located at a first vertical interval on the left post 101, and grooves or recesses 227 are located at a second vertical interval on the right side. In some embodiments, the first and second vertical intervals differ. The corresponding left hooks 15a and right hooks 15a include projections 225, which are located at a first and second vertical height, respectively, so that the left hooks 15a and right hooks 15a can be connected to either the left post 101 or the right post 101.

[0099] Unless otherwise clearly required by the context, terms such as “equipped with,” “included,” and “equipped with,” “included” should be interpreted throughout the specification and claims in a comprehensive sense, that is, “not limited to, but including,” rather than in an exclusive or exhaustive sense.

[0100] Any reference to prior art in this specification is not, and should not be interpreted as, an endorsement or any suggestion that such prior art constitutes part of the common general knowledge in any country in the world in any field of focus.

[0101] It is also possible to say that the inventions disclosed herein are, more broadly, in the parts, elements, and features that are referred to or shown individually or collectively in the specification of this application (in any combination of any or all of such parts, elements, or features).

[0102] Where the above description refers to a complete set or component having known equivalents, those complete sets are incorporated herein as if they were individually shown.

[0103] It should be noted that any modifications and changes to the currently preferred embodiments described herein will be obvious to those skilled in the art. Such modifications and changes can be made without departing from the spirit and scope of the invention and without diminishing its associated advantages. For example, the position of various components can be changed as required. Thus, such modifications and changes are intended to fall within the scope of the invention. Furthermore, not all features, embodiments, and advantages are necessarily required to carry out the invention. Thus, at least some of the scope of the invention is intended to be defined solely by the following claims.

Claims

1. A mask frame (5) for a user mask that delivers respiratory gas to the user, A central region (75) comprising a conduit connection aperture (77) configured to be connected to a respiratory gas delivery conduit, wherein a conceptual central vertical plane (y) extends through the center of the conduit connection aperture (77) and a conceptual front (80) extends radially outward from the conduit connection aperture (77), It comprises a first lateral arm and a second lateral arm (97), each extending outward from the central region (75) away from the central vertical plane (y), Each lateral arm (97) has a certain length and terminates at a distal end away from the central region (75), and each lateral arm (97) has an upper margin (93) and a lower margin (95), The distal end of each lateral arm (97) is provided with a headgear connector including a post (101) and a loop (99) configured to provide a connection point for the headgear. The lower margin (95) is closer to the front surface (80) than the end of the upper margin (93), so that the length of the post (101) forms an acute angle (α) with the front surface (80). The post (101) is a mask frame (5) that, when viewed perpendicular to the front, is inclined upward toward the central region (77).

2. The mask frame (5) according to claim 1, wherein the planar surface (81) extends radially outward from the conduit connection aperture (77), and the front surface (80) coincides with the planar surface (81).

3. The mask frame (5) according to claim 2, wherein the lateral arm (97) extends backward from the planar surface (81) and also from distal to proximal.

4. A mask frame (5) according to any one of claims 1 to 3, comprising a proximal side (71) and a distal side (73), wherein the loop (99) is a rectangular aperture extending perpendicular to the distal side (73) through the lateral arm (97).

5. The mask frame (5) according to claim 4, wherein the post (101) is formed by the outer wall of the loop (99) and forms the distal end of the lateral arm (97).

6. The mask frame (5) according to any one of claims 1 to 5, wherein the post (101) is substantially cylindrical.

7. The mask frame (5) according to any one of claims 1 to 6, wherein the angle of the post (101) with respect to the front (80) is such that the holding force (F) applied by the headgear (13) in use is substantially perpendicular to the angle of the post (101) with respect to the front (80).

8. The aforementioned lateral arm (97) i. From the central region (75) of the mask frame (5), outward in the lateral direction, ii. Towards the rear of the user's ear, iii. The lateral arms (97) are inclined upward so that they extend upward along a direction of extension that is parallel to a line extending from the end of the lateral arm (97) to the area between the user's temple and ear. An extending mask frame (5) according to any one of claims 1 to 7.

9. The mask frame (5) according to claim 8, wherein the lateral arm (97) extends upward along a vector that travels from below the user's nose to a point between the top of the ear and the side of the head.

10. The mask frame (5) according to claim 8 or 9, wherein each lateral arm (97) comprises a planar strip, the ends of which define an upper and lower corner in the upper margin and the lower margin, respectively, and the lateral arms are twisted along their lengths, so that the lower corner of the end of each lateral arm is positioned further away from the central region of the mask frame than the upper corner.

11. The mask frame (5) according to claim 10, wherein each lateral arm (97) is tapered along its length, i.e., the distance between the upper margin and the lower margin is reduced along at least a portion of the length of each lateral arm (97).

12. The mask frame (5) according to any one of claims 1 to 11, wherein the end of the lateral arm (97) is positioned below a conceptual horizontal midplane (x) passing through the center of the conduit connection aperture (77).

13. The mask frame (5) according to any one of claims 1 to 12, wherein the headgear connector includes a rotation limiting structure configured to limit the relative rotation between the headgear (13) connected to the headgear connector and the mask frame (5), and the rotation limiting structure includes an end stopper (225) to which the headgear abuts after a predetermined amount of relative rotation between the mask frame (5) and the headgear (13).

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