Frame and headgear for a respiratory mask system

Abstract

This application relates to frames and headgear for respiratory mask systems. A respiratory mask system has a patient interface comprising a frame (5) to secure a seal (4) and a gas delivery conduit (6) together. A recessed channel (106) and / or headgear retention feature (450) connects a headgear (3) to the patient interface. An inlet collar (114) connects the frame to the gas delivery conduit, converges, includes a bias flow aperture (127) forming a 240 degree arc, and has a distal rim with a top and bottom that protrude distally relative to lateral sides (Fig. 26B). The headgear includes a top strap, a pair of side arms, an optional rear strap, and a yoke configured to connect to the recessed channel (106). The top strap, side arms, and yoke form an integral closed loop (straps). A first edge of the strap includes a soft edge, and an opposite edge includes a soft edge portion and a rigid edge portion (Fig. 16). The top strap can include two portions that are adjustably connected to one another.

Description

[0001] This application is a divisional application of invention patent application 201780028702.2, filed on March 9, 2017, entitled "Frame and headband for a respiratory mask system".

[0002] By incorporating any priority claim

[0003] Any foreign or domestic priority claims identified in the application data page filed with this application are hereby incorporated by reference in accordance with 37 CFR 1.57. Technical Field

[0004] This disclosure generally relates to respiratory mask systems used to deliver respiratory therapy to patients. More specifically, this disclosure relates to various components of a respiratory mask system. Background Technology

[0005] Breathing masks are used to provide respiratory therapy to the airways of people suffering from any of a variety of respiratory diseases or conditions. Such therapies may include, but are not limited to, continuous positive airway pressure (CPAP) therapy and non-invasive ventilation (NIV) therapy.

[0006] CPAP therapy can be used to treat obstructive sleep apnea (OSA), a condition in which the airways of a patient intermittently collapse during sleep, thus preventing the patient from breathing for a period of time. The cessation of breathing, or pause in breathing, causes the patient to wake up. Repeated and frequent apneas can result in patients rarely sleeping through the night and therefore rarely recovering energy from nighttime sleep.

[0007] CPAP therapy involves delivering a continuous positive pressure supply to the patient's airway via a breathing mask. Continuous positive pressure acts as a splint within the patient's airway, holding it in an open position so that the patient's breathing and sleep are not interrupted.

[0008] A breathing mask typically includes a patient interface and a headband. The patient interface is configured to deliver a continuous positive pressure supply to the patient's airway via a seal or pad that forms a substantially airtight seal in or around the patient's nose and / or mouth. Breathing masks are available in various styles, including full-face masks, nasal masks, and direct oronasal masks, which together form a substantially airtight seal with the nose and / or mouth. The seal or pad is held in place on the patient's face by the headband. To maintain a substantially airtight seal, the headband should provide support for the patient interface so that it remains in a stable position relative to the patient's face during use. Such breathing masks can also be used to deliver NIV and other therapies. Summary of the Invention

[0009] In a first aspect, embodiments of the invention can be broadly described as including a headband for a breathing mask, the headband comprising an integrally formed closed loop. The closed loop includes a yoke, a pair of side arms, and a top strap. The yoke is configured to connect to a patient interface. Each of the pair of side arms is configured to extend laterally from the yoke and, in use, extend across the user's cheek and to above the user's ear. The top strap is configured to extend between the pair of side arms and, in use, extend across the top of the user's head.

[0010] Preferably, the top strap comprises separate left and right portions, each having a free end and a fixed end. The fixed end of the left portion is integrally formed with one of the side arms, and the fixed end of the right portion is integrally formed with the other side arm. The free ends of the left and right portions are adjustablely connected to each other.

[0011] Preferably, the closed loop is made of a semi-rigid material.

[0012] Preferably, the closed ring comprises a plastic material.

[0013] Preferably, the pair of side arms include an integrally formed buckle at the free end.

[0014] Preferably, the headband further includes a rear strap configured to extend between the buckles of the opposite side arms and to extend around the back of the user's head during use.

[0015] Preferably, the rear strap includes a pair of lateral ends, each of which is adjustablely connected to a buckle on the side arm.

[0016] Preferably, the rear strap is removably connected to a buckle.

[0017] Preferably, the rear strap and the top strap are configured to wrap around the rear portion of the user's head during use.

[0018] In a second aspect, embodiments of the present invention can be broadly described as including a breathing mask comprising a patient interface and a headband as described above.

[0019] In a third aspect, embodiments of the invention can be broadly described as including a headband for a breathing mask, the headband comprising an integrally formed closed loop and a rear strap. The closed loop includes a yoke, a pair of side arms, and a top strap. The yoke is configured to connect to a patient interface. Each of the side arms is configured to extend laterally from the yoke and, in use, extend across the user's cheek and above the user's ear. In use, the top strap is configured to extend across the top of the user's head, thereby connecting the side arms. The rear strap is configured to extend around the back of the user's head between the side arms.

[0020] In a fourth aspect, embodiments of the invention can be broadly described as including a headband for a breathing mask, the headband comprising a yoke, a pair of opposing side arms, and a top strap. The yoke is configured to attach to the frame of the breathing mask. The pair of opposing side arms are configured to extend rearward portions from a pair of sides of the yoke in use, and extend across the user's cheeks and above the top of the user's ears. The top strap is configured to extend between the pair of side arms above the top of the user's head in use. The yoke, side arms, and top strap are integrally formed to provide a closure loop that remains intact when the yoke is separated from the frame.

[0021] In some embodiments, the frame for a breathing mask includes a body having an outer surface and an inner surface. The outer surface includes a yoke receiving structure configured to receive a yoke and an inlet retainer defining an inlet. The yoke receiving structure may span a longitudinal distance of the body. The inner surface includes an outlet retainer defining an outlet. A gas passage is formed between the inlet and the outlet. The circumference of the gas passage at the inlet is smaller than the circumference of the gas passage at the outlet.

[0022] The inlet retaining ring may include a portion with an increased circumference. The inlet may have an elliptical shape. The outlet may have an elliptical shape. The outlet retaining ring may include a truncated portion. A portion of the outlet retaining ring may be longer than another portion of the outlet retaining ring. The outlet retaining ring may include a recessed portion extending partially around the outlet retaining ring.

[0023] In some embodiments, the frame for a breathing mask includes a body having an outer surface and an inner surface. The outer surface includes a yoke receiving structure configured to receive a yoke and an inlet retainer defining an inlet. The yoke receiving structure may span a longitudinal distance of the body. The inlet retainer includes a transition portion with an increased circumference. The inner surface includes an outlet retainer defining an outlet. A gas passage is formed between the inlet and the outlet. The inlet retainer includes a vent that allows gas to pass from the gas passage to the outside of the frame.

[0024] The inlet retaining ring may include a first portion having a first circumference and a second portion having a second circumference and coaxially offset from the first portion. The first and second portions may be separated by a transition portion with an increasing circumference, which may connect the first and second portions. The second circumference may be greater than the first circumference. The second portion may be located near the outer surface of the frame. The transition portion may include a vent. The vent may include multiple holes.

[0025] In some embodiments, the frame for a breathing mask includes a body having an outer surface and an inner surface. The outer surface includes a yoke receiving structure configured to receive a yoke and an inlet retainer ring defining an inlet. The yoke receiving structure may be defined between a first retaining ridge and a second retaining ridge, the second retaining ridge being vertically displaced from the first retaining ridge to form a recessed channel configured to receive the yoke. The inner surface may include an outlet retainer ring defining an outlet. A gas passage may be formed between the inlet and the outlet.

[0026] In some embodiments, the frame for a breathing mask includes a body, an inlet retainer, and an outlet retainer. The body has an outer surface and an inner surface, and extends from a first lateral edge to a second lateral edge. The inlet retainer extends from the outer surface, defines an opening, and is configured for coupling to a gas conduit in use. The outlet retainer extends from the inner surface. The body includes a first headband retaining feature and a second headband retaining feature, the first headband retaining feature being at least partially laterally positioned between the inlet retainer and the first lateral edge, and the second headband retaining feature being at least partially laterally positioned between the inlet retainer and the second lateral edge.

[0027] The frame and headband retaining features can be configured such that the first headband retaining feature engages with a corresponding first frame retaining feature on the headband, and then the frame and headband can rotate relative to each other about the headband retaining features to align the second headband retaining feature with a corresponding second frame retaining feature on the headband. The centers of both the first and second headband retaining features can be displaced in the vertical direction relative to the central axis of the opening extending through the inlet retainer ring. The first and second headband retaining features can be circular holes.

[0028] In some embodiments, the frame for the breathing mask includes: a body having an outer surface and an inner surface and extending from a first lateral edge to a second lateral edge; an opening configured to receive gas from a gas delivery conduit during use; and a plurality of deflection orifices disposed around a portion of the frame surrounding the opening and forming an arc extending approximately 240°.

[0029] These deflection orifices can extend from approximately 4:00 to approximately 8:00 (as on a clock face). The frame may further include an inlet retaining ring extending from the outer surface, the inlet retaining ring including a wall defining the opening and configured for connection to a gas conduit in use, the inlet retaining ring including a plurality of deflection orifices extending through the wall. The inlet retaining ring may have an elliptical cross-section. Because the wall of the inlet retaining ring extends away from the frame body, the wall may be angled inward relative to the axis extending through the opening at an inlet retaining ring surface angle. The surface angle of the inlet retaining ring may vary around the periphery of the inlet retaining ring.

[0030] In some embodiments, the frame for a breathing mask includes: a body having a distally facing outer surface and a proximally facing inner surface; and an inlet retainer extending distally from the outer surface to a distal edge, the inlet retainer including a wall defining an opening and configured for coupling to a gas conduit in use, wherein the top and bottom of the distal edge project distally relative to the lateral sides of the distal edge. The inlet retainer may have an elliptical cross-sectional shape.

[0031] In some embodiments, the headband for a breathing mask includes: a yoke configured for connection to a patient interface; a first side arm and a second side arm; a top strap; and at least one connector configured for connection to a frame in use. Each of the first and second side arms extends laterally from the yoke and is configured to extend across the user's cheek and then above the user's ear in use. The top strap is coupled to the first and second side arms and extends between the first and second side arms, and is configured to extend across the top of the user's head in use. At least one of the yoke, the first and second side arms, and the top strap includes a plastic core and a textile shell at least partially surrounding the plastic core, wherein the yoke, the first and second side arms, and the top strap are formed by internal molding, and wherein at least one connector is formed by a burst-through process such that at least one connector is integrally formed with the plastic core and extends to the outside of the shell.

[0032] The connector may include a channel separating two retaining portions. The connector may typically be circular. The headband may include two connectors, each configured to engage a corresponding headband retaining feature on the frame. The headband and connectors are configured such that a first connector of the two connectors can engage a corresponding first headband retaining feature on the frame, and then the frame and headband can rotate relative to each other about the connector to align a second connector of the two connectors with a corresponding second headband retaining feature on the frame.

[0033] In some embodiments, the headband for a breathing mask includes: a yoke configured to connect to a patient interface; a first side arm and a second side arm; and a top strap. Each of the first and second side arms extends laterally from the yoke and is configured to extend across the user's cheek and then above the user's ear during use. The top strap is coupled to the first and second side arms and extends between the first and second side arms, and is configured to extend across the top of the user's head during use. The top strap includes a first portion coupled to the first side arm, a second portion coupled to the second side arm, and an adjustment mechanism configured to engage the first and second portions and allow adjustment between the first and second portions. The adjustment mechanism includes a guide ring located at the free end of the second portion; a plurality of holes along the length of the second portion near the degree of freedom; a protrusion extending from the inner surface of the first portion, the inner surface being configured to face and at least partially cover the second portion when the first and second portions are joined in use, wherein the protrusion is configured to engage any one of the plurality of holes to secure the first and second portions together; and a plurality of positioning guides extending along the length of the first portion near the protrusion, these positioning guides including a series of protruding edges, the width of which is greater than the diameter of the opening defined by the guide ring. In use, the first portion is configured for advance through and / or withdrawal through the guide ring, and the contact between the protruding edges and the guide ring provides resistance to prevent the first portion from moving through the guide ring.

[0034] The top strap may include a plastic core and a textile outer shell at least partially surrounding the plastic core, wherein the second portion includes a surrounding channel extending around at least one of a plurality of holes, and wherein the outer shell does not surround the surrounding channel. The protrusion may include a post extending from and adjacent to the inner surface of the first portion, and an enlarged head at the end of the post, the enlarged head having a diameter larger than that of the post.

[0035] In some embodiments, the headband for a breathing mask includes a strap and a top strap, wherein the strap includes a yoke portion and first and second side arms. The yoke portion is configured to connect to a patient interface. Each of the first and second side arms extends laterally from the yoke portion and is configured to extend across the user's cheek and then over the user's ear during use. The yoke portion and the first and second side arms may be integrally formed. The top strap is coupled to the first and second side arms and extends between the first and second side arms, and is configured to extend across the top of the user's head during use. A first edge of the strap includes a soft edge, and a second opposing edge of the strap includes a soft edge portion and a rigid edge portion.

[0036] The thickness of the soft edge of the first edge can vary between a maximum thickness at the lateral end of the side arm and a minimum thickness near the center point of the yoke. The thickness of the soft edge portion of the second edge can vary between a maximum thickness at the lateral end of the side arm and a minimum thickness at a point laterally spaced from the center of the yoke.

[0037] In some embodiments, the headband for a breathing mask includes a front strap and a top strap. The front strap includes a yoke configured for connection to a patient interface, and a first side arm portion and a second side arm portion; each of the first and second side arm portions extends from a lateral end of the yoke and is configured to extend across the user's cheek and then above the user's ear during use. The top strap is coupled to the first and second side arm portions and extends between the first and second side arm portions, and is configured to extend across the top of the user's head during use. The top strap includes a first portion coupled to the first side arm portion, a second portion coupled to the second side arm portion, and an adjustment mechanism configured to engage the first and second portions and allow adjustment between the first and second portions. At least one of the yoke, the first and second side arm portions, and the top strap includes a plastic core and a textile shell at least partially surrounding the plastic core. In some embodiments, at least one of the yoke, the first and second side arm portions, and the top strap may be formed by internal molding.

[0038] The adjustment mechanism may include a first interlocking portion (such as a female connector located at the free end of a second portion) and a second interlocking portion (such as a male connector located at the free end of a first portion), wherein, in use, the first and second interlocking portions are configured to selectively engage in one of a plurality of discrete configurations to set the length of the top strap. The first interlocking portion may include a female connector including a plurality of holes along its length. The second portion may further include a guide ring, and in use, the first portion is configured to be advanced through and / or withdrawn through the guide ring. The second interlocking portion may include a male connector including a protrusion extending from an inner surface of the male connector. At least a portion of the second interlocking portion may be configured to cover at least a portion of the first interlocking portion when engaged with the first interlocking portion, and the protrusion may be configured to engage any of the plurality of holes to secure the first and second portions together. The male connector may include a gripper located on or within its outer surface. The male connector may include a gripper located on or within its inner surface. A first portion of the top strap may be coupled to a first side arm portion via an overmolded joint, and a second portion of the top strap may be coupled to a second side arm portion via an overmolded joint. The headband may further include buckles located at the lateral ends of each of the first and second side arm portions, the buckles being configured to receive a rear strap. The buckles may be overmolded onto the lateral ends of both the first and second side arm portions. The yoke may include two frame retaining features, each configured to engage a corresponding headband retaining feature on the frame. These frame retaining features may be horseshoe-shaped. The front strap may include pads surrounding and extending laterally outward from each of these frame retaining features, the pads being thicker than the remainder of the front strap. In some embodiments, the female connector may include a guide ring and a plurality of holes along the length of the female connector, and the male connector may include a protrusion extending from an inner surface of the male connector, the inner surface being configured to face the female connector and at least partially cover the female connector when the first and second portions are engaged in use, wherein the protrusion is configured to engage any one of the plurality of holes to secure the first and second portions together. In use, the first portion is configured to be advanced through and / or withdrawn through the guide ring.

[0039] A female connector may be overmolded onto the second portion. A male connector may be overmolded onto the first portion. The male connector may include a gripper located on or within the outer surface of the male connector. The male connector may include a gripper located on or within the inner surface of the male connector. A first portion of the top strap may be coupled to a first side arm portion via an overmolded engagement. A second portion of the top strap may be coupled to a second side arm portion via an overmolded engagement. The headband may further include buckles at the lateral ends of each of the first and second side arm portions, each of these buckles being configured to receive an end of the rear strap. Buckles may be overmolded onto the lateral ends of both the first and second side arm portions. The yoke may include two frame retaining features, each frame retaining feature being configured to engage a corresponding headband retaining feature on the frame. These frame retaining features may be horseshoe-shaped. The front strap may include pads that surround and extend laterally outward from each of these frame retaining features, the pads being thicker than the rest of the front strap.

[0040] Further aspects of the invention should be considered in light of all its novel aspects, which will become apparent from the following description. Attached Figure Description

[0041] Several embodiments will now be described by way of example with reference to the accompanying drawings, in which:

[0042] Figure 1 This is a perspective view of a first non-limiting exemplary embodiment of the breathing mask according to this disclosure.

[0043] Figure 2 yes Figure 1 Front perspective view of the frame of the breathing mask.

[0044] Figure 3 yes Figure 2 The back perspective of the frame.

[0045] Figure 4 yes Figure 2 The front view of the frame.

[0046] Figure 4A yes Figure 2 The front view of the frame.

[0047] Figure 5 yes Figure 2 The left-side view of the frame.

[0048] Figure 5A yes Figure 2 The left-side view of the frame.

[0049] Figure 5B yes Figure 2 A left-side view of an alternative embodiment of the frame.

[0050] Figure 6 yes Figure 2 The rear view of the frame.

[0051] Figure 6A yes Figure 2 The rear view of the frame.

[0052] Figure 7 yes Figure 2 The top view of the frame.

[0053] Figure 7A yes Figure 2 A top view of an alternative embodiment of the frame.

[0054] Figure 8 yes Figure 2 The bottom view of the frame.

[0055] Figure 9 yes Figure 2 The front view of the frame, with the central cross-section cut off.

[0056] Figure 10 yes Figure 2 The central cross-sectional view of the frame.

[0057] Figure 10A yes Figure 2 A 2D view of the central cross-section of the frame.

[0058] Figure 11 This is a perspective view of a second non-limiting exemplary embodiment of the breathing mask according to this disclosure.

[0059] Figure 12 It is in use Figure 11 Side view of a breathing mask.

[0060] Figure 13 yes Figure 11 and Figure 12 A front view of a portion of the headband of a breathing mask, the headband being in a disengaged engagement arrangement.

[0061] Figure 14 yes Figure 13 A close-up side view of the top strap of the headband, which is in a disengaged engagement arrangement.

[0062] Figure 15 yes Figure 11 A perspective view of the top of the breathing mask.

[0063] Figure 16 yes Figure 13 A close-up front view of the yoke of the headband, in a disengaged engagement arrangement.

[0064] Figure 17 yes Figure 13 A close-up plan view of the yoke of the headband, which is in a disengaged engagement arrangement.

[0065] Figure 18 It is used with Figure 1 A perspective view of a second non-limiting exemplary embodiment of a breathing mask combined with a headband.

[0066] Figure 19 yes Figure 18 Front perspective view of the yoke of the headband.

[0067] Figure 20 This is a perspective view of a non-limiting exemplary embodiment of the breathing mask according to this disclosure.

[0068] Figure 21 yes Figure 20 Front perspective view of the frame of the breathing mask.

[0069] Figure 22 yes Figure 21 The back perspective of the frame.

[0070] Figure 23A yes Figure 21 The front view of the frame shows the frame's axis.

[0071] Figure 23B yes Figure 21 The front view of the frame shows various axes and dimensions.

[0072] Figures 24A-24B It shows that Figure 20 The headband of the breathing mask is connected to Figure 21 The framework method.

[0073] Figure 24C yes Figure 21 A front view of an alternative embodiment of the framework.

[0074] Figure 24D yes Figure 21 A front perspective view of an alternative embodiment of the framework.

[0075] Figure 25 yes Figure 20 A partial exploded perspective view of a breathing mask.

[0076] Figure 26A yes Figure 21 The side view of the frame.

[0077] Figure 26B yes Figure 21 The side view of the frame shows various axes and dimensions.

[0078] Figure 26C yes Figure 21 A partial cross-sectional view of the entrance ring of the frame.

[0079] Figure 26D yes Figure 21 The front view of the frame.

[0080] Figure 27A yes Figure 21 The rear view of the frame shows the various axes.

[0081] Figure 27B yes Figure 21 The rear view of the frame shows various axes and dimensions.

[0082] Figure 28 yes Figure 21 The side view of the frame.

[0083] Figure 29A yes Figure 21 The top view of the frame.

[0084] Figure 29B yes Figure 29A A top view of an alternative embodiment of the frame.

[0085] Figure 29C yes Figure 21 The top view of the frame.

[0086] Figure 30 yes Figure 21 The bottom view of the frame.

[0087] Figure 31 yes Figure 21 A partial front view of the frame, showing the cross-sectional plane.

[0088] Figure 32A yes Figure 21 The framework along Figure 31 The cross-sectional view taken from line 32A-32A in the diagram.

[0089] Figure 32B yes Figure 32A A 2D view of the cross section.

[0090] Figure 33 This is a perspective view of a non-limiting exemplary embodiment of the breathing mask according to this disclosure.

[0091] Figure 34 It is being worn by the user. Figure 33 The image shows a side view of the breathing mask.

[0092] Figure 35A yes Figure 33 Rear view of the yoke of the headband of the mask.

[0093] Figure 35B yes Figure 33 The rear view of the yoke of the headband of the mask shows the gate used in the molding process.

[0094] Figure 36A yes Figure 33 The face mask's headband frame maintains its characteristic side view.

[0095] Figure 36B yes Figure 36A The side view of the frame retains its features, showing the outline of the headband's outer shell.

[0096] Figure 36C It is used to form Figure 36A The frame retains the features of the mold's side view.

[0097] Figure 37 yes Figure 33 Front view of the yoke of the headband and multiple side arm sections of the mask.

[0098] Figure 38A yes Figure 33 A close-up view of part of the headband of the mask.

[0099] Figure 38B yes Figure 33 A close-up view of part of the headband of the mask.

[0100] Figure 39 yes Figure 33 A top view of the headband of the mask.

[0101] Figure 40 It is in a disengaged position or configuration. Figure 33 Top perspective view of the top strap of the headband of the mask shown.

[0102] Figure 41 yes Figure 40 A close-up view of a portion of the second part of the top strap.

[0103] Figure 42 yes Figure 33 A close-up view of a portion of the headband of the mask, showing an embodiment of the connection between the side arms and the top strap of the headband.

[0104] Figure 43A This is a bottom view of an example embodiment of a positioning guide for the first part of the top strap of the headband.

[0105] Figure 43B This is a bottom view of an example embodiment of a positioning guide for the first part of the top strap of the headband.

[0106] Figure 43C This is a side view of a portion of the first part of the top strap.

[0107] Figure 44 This is a top perspective view of a non-limiting exemplary embodiment of the breathing mask assembly according to this disclosure.

[0108] Figure 45 yes Figure 44 Front view of the breathing mask assembly.

[0109] Figure 46 yes Figure 44 Rear view of the headband of the breathing mask assembly.

[0110] Figure 47A yes Figure 46 Rear or interior view of the disconnected and unfolded portion of the headband.

[0111] Figure 47B yes Figure 47A The front or external view of that part of the headband.

[0112] Figure 48A yes Figure 47A The front or external view of the right side of the headband.

[0113] Figure 48B yes Figure 48A The rear view or interior view.

[0114] Figure 49A yes Figure 47A The front or external view of the left side of the headband.

[0115] Figure 49B yes Figure 49A The rear view or interior view.

[0116] Figure 50A yes Figure 46 and Figure 47A Front or external view of the male connector of the headband.

[0117] Figure 50B yes Figure 50A Rear or interior view of the male connector.

[0118] Figure 50C yes Figure 50A A perspective cross-sectional view of a variant of the male connector.

[0119] Figure 51A and Figure 51B It shows that Figure 50A male connector and Figure 46 and Figure 47A Different methods for connecting and / or disconnecting the female connector of the headband.

[0120] Figure 52A yes Figure 46 A partial perspective exterior view of the top strap of the headband.

[0121] Figure 52B yes Figure 52A A partial interior view of the top strap.

[0122] Figure 53A yes Figure 46 Partial external view of the bottom strap of the headband.

[0123] Figure 53B yes Figure 53A A partial internal view of the bottom strap.

[0124] Figure 54A yes Figure 52A Top strap and Figure 53A A partial external view of the joint between the bottom straps.

[0125] Figure 54B yes Figure 54A A perspective view of the joint.

[0126] Figure 55A yes Figure 54A A partial internal view of the joint and one end of the bottom strap.

[0127] Figure 55B yes Figure 54A A cross-sectional view of the joint.

[0128] Figure 56A It is a partial interior view of the overmolded joint between the top strap and the bottom strap, and the buckle overmolded to the end of the bottom strap.

[0129] Figure 56B yes Figure 56A The external view.

[0130] Figure 57 yes Figure 56A A cross-sectional view of the molded joint.

[0131] Figure 58 It is molded onto the top strap. Figure 50A The cross-sectional view of the male connector is shown.

[0132] Figure 59 This is a perspective view of an alternative embodiment of one end of the top strap.

[0133] Figure 60A yes Figure 46 Rear view of the bottom strap of the headband and the yoke.

[0134] Figure 60B yes Figure 60A The bottom view of the yoke.

[0135] Figure 61 yes Figure 44 Top perspective view of the frame and front of the gas delivery conduit of the breathing mask assembly.

[0136] Figure 62A It is connected to Figure 61 The framework Figure 60A The rear view of the bottom strap is shown.

[0137] Figure 62B yes Figure 62A Front view of the bottom straps and frame.

[0138] Figure 63 This is a rear view of an alternative embodiment of the bottom straps and yoke.

[0139] Figure 64 The relative dimensions of the buckle and the bottom strap are shown. Detailed Implementation

[0140] This disclosure relates to a frame and headband for a respiratory mask system configured to deliver respiratory therapy to a patient / user. Figure 1 A non-limiting exemplary embodiment of the respiratory mask system 1 disclosed herein is shown. The respiratory mask system 1 includes a patient interface 2 and a headband 3. The patient interface 2 includes a seal 4, a frame 5, and a gas delivery conduit 6.

[0141] Patient interface 2 is configured to provide an air path through which pressurized air is supplied to the user's airway. In the embodiment shown and detailed below, patient interface 2 is a nasal mask, particularly a subnasal or under-nose mask, having a seal 4 configured to seal against the lower surface of the patient's / user's nose. Seal 4 is configured to form an airtight seal below the patient's / user's nose, along a portion of the face extending laterally toward the nose, and along the user's upper lip.

[0142] In some embodiments, the seal 4 may be adapted to extend around or seal over a wing or alar of the nose, the wing or alar of the nose being open to form a circular bulge around the nostrils. The illustrated mask 1 is adapted to seal around those surfaces defining openings to the nostrils, which may include part or all of the fleshy outer end of the nasal septum (sometimes called a columella). In some configurations, the seal 4 is adapted to extend upward to seal along at least a portion of both the left and right dorsal sidewalls of the user's nose. In some configurations, the seal 4 is adapted to extend upward along at least a portion of both the left and right dorsal sidewalls, but not upward to the area of ​​the user's nasal bridge. In some configurations, the primary sealing surface of the seal 4 contacts the lower side of the user's nose, the upper lip, and / or the transition area between the lower side of the nose and the upper lip. The secondary sealing surface of the mask may contact the lateral surface of the user's nose and may also incidentally contact the cheek at some location near the nose. Such primary and secondary sealing surfaces may not come into contact with the faces of all users; however, this arrangement can provide a suitable seal for a relatively wide range of facial geometries.

[0143] In the illustrated configuration, the seal 4 does not extend over the user's nose bridge. More specifically, the illustrated seal 4 does not contact the user's nose bridge. This is advantageous because contact with the nose bridge, and thus applying pressure to it, could cause pressure sores and discomfort for the user. If the seal causes pain or discomfort to the user, the user may become uncooperative with the treatment.

[0144] As described above, a mask with a seal 4 located below or under the nose may be less stable on the user's face compared to a more conventional mask that contacts the bridge of the nose, because the former has a smaller contact area with the user's face. The smaller contact area provides less constraint on how the seal 4 can move relative to the user's face, thus allowing the seal 4 to roll or rotate relative to the user's face. Any rolling or rotation of the seal 4 can break the essentially airtight seal between the seal 4 and the user's face, thereby impairing the delivery of respiratory therapy. In some embodiments, the instability of the seal 4 can be reduced by providing a headband 3 that can redirect forces away from the seal 4 to other parts of the user's head.

[0145] Frame 5 is configured to provide a manifold that connects multiple components of patient interface 2 together and secures them to headband 3. Frame 5 may include features configured to fluidly connect gas delivery conduit 6 to seal 4, thereby providing a continuous air path.

[0146] The headband 3 is configured to secure the patient interface 2 to the user's face during use. The headband 3 includes a top strap 7, a pair of side arms 8, and a yoke 9, which are permanently connected to form a closed loop. In use, the top strap 7 is configured to pass over the top of the user's head, the side arms are configured to extend across the user's cheeks, and the yoke 9 is configured to connect to the frame 5. The headband 3 further includes a rear strap 10, which is adjustablely connected to the side arms 8 and configured to wrap around the back of the user's head during use.

[0147] It should be understood that although the headband 3 and frame 5 disclosed herein are described as being used in conjunction with a subnasal mask, they can be used in conjunction with any other type of mask, including but not limited to nasal plugs or nasal pillow masks, full-face masks that seal above and / or below the bridge of the nose, or nasal masks.

[0148] frame

[0149] Figure 2 and Figure 3 A perspective view of a first non-limiting exemplary embodiment of frame 100 is shown, which is substantially similar to Figure 1 The frame 5 forms part of the breathing mask system. Vertical axis 105 and horizontal axis 107 ( Figure 4 (As shown in the diagram) is defined as having an origin at the center point of the inlet retaining ring 114 of the frame 100. The frame 100 is symmetrical about the vertical axis 105. The frame 100 has an outer surface 102 and an inner surface 103. The outer surface 102 serves as the interface between the frame 100, the headband 3, and the gas delivery conduit 6. The outer surface 102 includes a recessed channel 106. The recessed channel is defined by a first retaining ridge 104 and a second retaining ridge 108, and is located between the first retaining ridge and the second retaining ridge. The first retaining ridge 104 is vertically displaced from the second retaining ridge 108, and the space between the first retaining ridge 104 and the second retaining ridge 108 defines the recessed channel 106. The recessed surface 110 is located near the second retaining ridge 108. In use, the yoke 9 is inserted into the recessed channel 106. The headband 3 is connected to the frame 100 by inserting the yoke 9 into the recessed channel.

[0150] The outer surface 102 further includes an inlet retaining ring 114. The inlet retaining ring 114 includes a centrally located inlet retaining ring opening 115. The inlet retaining ring 114 also includes an inner retaining ring surface 116 and an inlet retaining ring surface 118. The inlet retaining ring 114 may further include a conduit retaining protrusion 122, a plurality of seal retaining recesses 130, and / or a plurality of vent holes 127. A first retaining ridge 104 extends from a first lateral edge 126 of the frame 100 to its second lateral edge 128. A second retaining ridge 108 extends from the first lateral edge 126 and meets at a laterally displaced connection 112a with the inlet retaining ring surface 118 of the inlet retaining ring 114. The second retaining ridge 108 disperses from the inlet retaining ring 114 at a second laterally displaced connection 112b and extends to the second lateral edge 128.

[0151] The inner surface 103 may contact the seal 206 or a clamp connected to the seal 206, and extends from a first lateral edge 126 of the frame 100 to its second lateral edge 128. The inner surface 103 includes an outlet retaining ring 137 that extends proximally from the frame 100 relative to the user, thereby forming an outlet retaining ring opening 117. In the illustrated embodiment, a plurality of seal retaining recesses 130 are located on the outlet retaining ring surface 124 to facilitate interaction between the frame 100 and the seal 206.

[0152] Figure 4 and Figure 4A A front view of the frame 100 aligned with the inlet retainer opening 115 is shown. The frame 100 acts as a manifold connecting multiple components of the breathing mask system. The inlet retainer opening 115 is elliptical, having a major axis 113 and a minor axis 111. In alternative embodiments, the inlet retainer 114 may be circular, triangular, or follow the contour of any other desired polygon.

[0153] Frame 100 is symmetrical about the minor axis 111 of inlet retainer 114. In the illustrated configuration, the minor axis 111 is aligned with the vertical axis 105. In the illustrated configuration, inlet retainer opening 115 is substantially located at the center of frame 100. Inlet retainer opening 115 has a major dimension 145 (e.g., length along its major axis 113) and a minor dimension 143 (e.g., length along its minor axis 111). Furthermore, in the illustrated configuration, the major dimension 145 of inlet retainer opening 115 is 20.7 mm, and the minor dimension 143 of inlet retainer opening 115 is 17.2 mm. Alternatively, the ratio between the major dimension 145 and the minor dimension 143 of inlet retainer opening 115 is approximately 1.2:1.

[0154] This ratio is determined, at least in part, by the physical characteristics or shape of the gas delivery conduit used in the breathing mask system. Additionally, minimizing the pressure drop between the pressure generating device and the user also influences the possible range of ratios between the primary dimension 145 and the secondary dimension 143. Pressure drop is a phenomenon known to occur in breathing mask systems, where a decrease in pressure occurs between the pressure generating device and the outlet of the breathing mask system. Pressure drop is primarily caused by flow resistance and inefficiency within the system. Minimizing the pressure drop observed in the breathing mask system improves the efficacy of the therapy delivered to the user.

[0155] The pressure drop that can be measured at both ends of the breathing mask system increases with the increase of the ratio between the primary dimension 145 and the secondary dimension 143 of the inlet retainer opening 115. However, increasing the ratio of the primary dimension 145 to the secondary dimension 143 is advantageous because it allows for a reduction in the physical profile of the frame 100. This, in turn, allows for a reduction in the overall profile of the breathing mask system. Therefore, in other embodiments of the frame 100, the ratio between the primary dimension 145 and the secondary dimension 143 of the inlet retainer opening 115 can vary from approximately 1:1 to approximately 2:1.

[0156] See you again Figure 4 The recessed channel 106 extends from the first lateral edge 126 of the frame 100 to its second lateral edge 128. Similarly, the first retaining ridge 104 extends from the first lateral edge 126 of the frame 100 to its second lateral edge 128.

[0157] The plurality of lateral portions of the second retaining ridge 108 are substantially concave relative to the transverse axis 107. The plurality of lateral portions of the second retaining ridge 108 are defined by a curved region near the connecting portion 112, wherein the relative concavity changes from concave to convex when the second retaining ridge 108 meets the inlet retaining ring surface 118.

[0158] In the illustrated embodiment, the recessed channel 106 extends beyond the inlet retaining ring 114. The recessed channel 116 is arc-shaped and extends beyond the inlet retaining ring 114. This is advantageous because the arc-shaped shape of the recessed channel 116 allows for the effective distribution of forces generated by the seal and headband.

[0159] The first retaining ridge 104 and the second retaining ridge 108 project outward from the outer surface 102 of the frame in a direction toward the inlet retaining ring 114. The inlet retaining ring 114 includes a wall extending from the outer surface 102. The vertical thickness or height, or outward extension, of the recessed channel 106 can be defined as the displacement between a point on the first retaining ridge 104 adjacent to the recessed channel 106 and a corresponding point on the second retaining ridge 108 adjacent to the recessed channel 106, each of these points being aligned on a common vertical axis. When defined in this way, the points with the greatest vertical thickness of the recessed channel 106 are located at the first lateral edge 126 and the second lateral edge 128 of the frame 100. The point with the least vertical thickness of the recessed channel 106 is located on the vertical axis 105.

[0160] As the first lateral edge 126 and the second lateral edge 128 are translated laterally and inward toward the vertical axis 105 of the frame 100, the vertical thickness or height of the recessed channel 106 decreases. In the illustrated configuration, the minimum vertical thickness of the recessed channel 106 is approximately 5.8 mm, and the maximum vertical thickness of the recessed channel 106 is approximately 12.7 mm. Therefore, the ratio between the minimum and maximum vertical thickness of the recessed channel 106 is approximately 1:2.25. The vertical thickness of the recessed channel 106 corresponds to the thickness of the yoke 9 of the headband 3 used with the frame 100. In some configurations, the ratio between the minimum and maximum vertical thickness of the recessed channel 106 may be between approximately 1:1 and 1:4.

[0161] The vertical thickness of the recessed channel 106 is reduced along a portion of the length of the frame 100, or at least within its central location, thereby reducing or minimizing the vertical profile of the frame 100. Reducing or minimizing the vertical profile of the frame 100 not only reduces the actual and perceived abruptness of the frame but also reduces or minimizes its mass, which is desirable for improving user comfort and increasing user compliance with the therapy. The reduction in the vertical thickness of the recessed channel 106 near the lateral center of the frame 100 also provides alignment features between the yoke 9 and the recessed channel 106. These alignment features ensure that the yoke 9 can be attached to the frame 100 in only one orientation, thus preventing improper assembly of the headband 3 to the frame 100.

[0162] The yoke 9 can be connected to the frame 100 via the recessed channel 106 using any relevant connecting means. The yoke 9 can be bonded to the recessed surface 106 using an adhesive. In some configurations, the yoke 100 can be connected to the frame 100 using a snap-fit ​​mechanism, a friction-fit mechanism, or a hook-and-loop fastening mechanism. In other configurations, the recessed surface may include one or more protrusions designed to engage in recesses or holes in the yoke, such that the combination of the protrusions and corresponding recesses or holes allows the yoke to engage with the frame. Alternatively, the recessed surface 106 may include one or more recesses or holes, such that the yoke engages with the frame using one or more corresponding protrusions on the yoke.

[0163] Alternative configurations of frame 100 can utilize multiple alternative recessed channel profiles. For example, the recessed channel can extend above the top of the entry ring (e.g., Figure 4 and Figure 4A (As shown), it can also extend below the inlet retaining ring. In another alternative configuration, the frame includes two or more recessed channels that can extend laterally across the outer surface of the frame. In some configurations, these recessed channels may include portions where associated retaining ridges are adjacent to each other, or where two recessed channels share a common retaining ridge. In some configurations, these recessed channels may not include adjacent portions. In some configurations, one or more recessed channels may all pass over the inlet retaining ring. In some configurations, one or more recessed channels may all pass under the inlet retaining ring.

[0164] In some configurations, two or more recessed channels may initially disperse from a common recessed channel near a lateral edge, deflect around the inlet retainer, and then converge to a common recessed channel near opposite lateral edges of the frame. In some configurations, the multiple recessed channels may be completely independent on the outer surface of the frame. In other words, each of the independent recessed channels may have its own independent retaining ridge, or may share a common retaining ridge with another independent recessed channel while maintaining complete separation of the channels themselves. In each of the aforementioned variations, one or more of the recessed channels may serve as an interface for connecting the headband 3 of the breathing mask system to the frame 100.

[0165] See you again Figure 4The recessed surface 110 extends from the first lateral edge 126 across the inlet retaining ring 114 to the second lateral edge 128 of the frame 100. The recessed surface 110 is adjacent to the second retaining ridge 108 on the outer surface 102 of the frame 100 and the inlet retaining ring 114. In the illustrated configuration, the recessed surface 110 helps to provide support for the seal 206 and maintain the structural integrity of the frame 100 both during manufacturing and during use. However, in alternative embodiments, the frame 100 may be completely without the recessed surface 110.

[0166] according to Figure 4A The lateral length 125 of the frame 100 in the illustrated embodiment is approximately 56.00 mm. Therefore, the ratio between the main dimension 145 of the inlet retainer opening 115 and the lateral length 125 of the frame 100 is approximately 1:2.70. This specified lateral length 125 of the frame 100 has been used to optimize the performance of the frame 100 when combined with the seal 206 and headband 3. It is desirable for the headband 3 to bend around the user's face to a relatively large extent. This performance is desired to maximize the facial contour variations that the breathing mask system can accommodate. The frame 100 has a sufficiently large lateral length 125 that allows for at least a certain degree of headband bending and reduces displacement of the seal 206.

[0167] In an alternative embodiment of frame 100, the lateral length 125 can vary from approximately 45.00 mm to approximately 75.00 mm. This variation can be used to accommodate different sizes of seals 206, different profiles of headbands 3, or different headband connection methods.

[0168] The vertical length 129 of the frame 100 is such that it provides a structure large enough to allow the headband 3 to be effectively connected to the frame 100, and to provide the necessary structural and rotational integrity required for the seal 206.

[0169] In alternative embodiments of the frame, the vertical length of the frame can vary from approximately 25.00 mm to approximately 50.00 mm. This variation can be used to accommodate different seal sizes, different profiles of the headband 3, or different headband connection methods.

[0170] Figure 5 and Figure 5A It shows Figure 1The figure shows a left-side view of frame 100 (relative to the user). Frame 100 is shown from one side. The figure shows the vertical axis 105, the inlet proximal axis 131, and the outlet proximal axis 133. In the shown configuration, the inlet proximal axis 131 intersects the vertical axis 105 at a right angle and is centered relative to the inlet retainer opening 115. In other words, the inlet proximal axis 131, the horizontal axis 107 (see...) Figure 4 The vertical axis 105 and the inlet proximal axis 131 form a 3D space sharing a common origin. The inlet proximal axis 131 is approximately parallel to the airflow passing through the inlet retainer opening 115. The outlet proximal axis 133 intersects the vertical axis 105 at a right angle. In other words, the outlet proximal axis 133 and the secondary horizontal axis 109 ( Figure 6 (As shown in the diagram) and vertical axis 105 share a common intersection point. The outlet proximal axis 133 is parallel to the airflow passing through the outlet retainer opening 117 of the frame 100. The inlet proximal axis 131 is vertically displaced relative to the outlet proximal axis 133. In the illustrated configuration, the inlet proximal axis 131 is parallel to the outlet proximal axis 133. In an alternative configuration, the outlet proximal axis 133 and the inlet proximal axis 131 may be aligned on the vertical axis 105.

[0171] like Figure 5A As observed, the distal edge (relative to the user) of the inlet retainer 114 is aligned with the vertical axis 105. In an alternative configuration, the edge of the inlet retainer may be angled relative to the vertical axis 105.

[0172] In the illustrated configuration, the inlet retainer surface 118 includes a first portion having a first outer circumference, a second portion coaxially offset from the first portion and having a second outer circumference, and a transition portion integral with the first portion and connecting the first portion to the second portion. In the illustrated configuration, the outer circumference of the second portion is greater than that of the first portion, and the second portion is displaced proximally (when worn by a user) relative to the first portion. The circumference difference between the first and second portions of the inlet retainer 114 creates the transition portion, which forms an angled surface 135 angled relative to the proximal inlet axis 131. This angled surface 135 facilitates an increase in circumference. In some configurations, the inlet retainer surface 118 will include only the angled surface. In other configurations, the inlet retainer surface 118 may include a combination of the angled surface and a surface that is not angled relative to the proximal inlet axis 131.

[0173] As shown in the attached diagram, the circumference of the inlet retaining ring 114 is smaller than the circumference of the outlet retaining ring 137. The inlet retaining ring 114 has a different shape than the outlet retaining ring 137.

[0174] An angled surface 135 spans the periphery of the inlet retainer surface 118. The protrusion of the angled surface 135 on the inlet proximal axis 131 has a substantially constant length at all points along the periphery of the inlet retainer surface 118. The angled surface 135 forms an angle of approximately 10° with respect to the inlet proximal axis 131. The displacement between the angled surface 135 and the distal edge of the inlet retainer surface 118 (relative to the user) varies about the circumference of the inlet retainer surface 118. In the illustrated embodiment, the angled surface 135 includes a plurality of deflection orifices 127. Figure 4 , Figure 5A and Figure 7 In the configuration shown, deflection orifices 127 are located on an angled surface 135 and extend substantially around the angled surface 135. These deflection orifices discharge deflected flow substantially vertically relative to the inlet proximal axis 131.

[0175] An angled surface 135 is included on the inlet retainer surface 118 to beneficially influence the orientation of the deflector 127. However, a problem with vertically oriented orifices (orifices oriented at 90° to the inlet proximal axis 131) is that users experience an uncomfortable dragging sensation when using the mask system. When the deflector 127 of the frame 100 is located on the angled surface 135, it is angled away from the user. Therefore, during use, the airflow through the deflector 127 is directed away from the user. This prevents the user from experiencing an uncomfortable dragging sensation when using the mask system. An alternative embodiment of the frame 100 may include the angled surface 135 having a varying angle relative to the inlet proximal axis 131. In some configurations, this angle may be between 0° and 20°, or between 5° and 15°. In other configurations, this angle may be greater than 20°.

[0176] In other configurations, the deflector holes may span the entire circumference of the angled surface. Alternatively, the deflector holes may be arranged on the surface of the inlet retainer ring. This configuration may include one or more rows of deflector holes, which may be aligned or offset relative to each other. In other configurations, these deflector holes may be located at any other location on the frame 100 in any desired configuration. Some configurations of the frame may include a single vent. Other configurations may include a single vent with a diffuser. The diffuser may be integrated with the vent or may be attached to the frame 100 on the vent. When the breathing mask system is operational, the diffuser in this configuration can be used to diffuse noise emanating from the vent.

[0177] See you again Figure 5 and Figure 5AThe side profile of the recessed channel 106 is shown. It can be seen that the recessed channel 106 is concave relative to the user in the lateral direction. The concavity of the recessed channel 106 can vary along the lateral length of the frame 100. This is a result of the reversal of the recessed channel 106 along its length. The identified curvature of the recessed channel 106 allows the profile of the frame 100 to provide sufficient structural support for the seal 206 of the breathing mask system.

[0178] See Figure 6 and Figure 6A , Figure 6 A rear view of frame 100 is shown relative to vertical axis 105 and horizontal axis 107. The outlet retainer opening 117 is centered on frame 100 relative to vertical axis 105. The origin of outlet retainer opening 117 is aligned with secondary horizontal axis 109. The secondary horizontal axis is displaced vertically from horizontal axis 107. In some configurations of frame 100, secondary horizontal axis 109 may be aligned with horizontal axis 107.

[0179] Figure 6A A rear view of the frame 100 is shown, also illustrating that the shape of the outlet retaining ring 137 is defined as similar to a truncated circle or a partial D-shape, and that the outlet retaining ring includes an outlet major axis 119, an outlet minor axis 121, and a truncated portion 123. The truncated portion 123 of the outlet retaining ring 137 allows the profile of the frame 100 to be reduced relative to a frame without the truncated portion. Additionally, the truncated portion 123 provides an orientation feature to ensure proper orientation of the sealing connection with the frame. The truncated portion 123 also reduces the chance of misalignment when the seal 206 is to be attached to the frame 100. The truncated portion also prevents the seal 206 from rotating relative to the frame 100.

[0180] In the illustrated configuration, the outlet retaining ring opening 117 includes both a larger lateral profile and a larger vertical profile than the inlet retaining ring opening 115. Therefore, the perimeter of the outlet retaining ring opening 117 is greater than the perimeter of the inlet retaining ring opening 115. This larger profile is advantageous from both a functional and manufacturability perspective. Functionally, when the frame 100 has an outlet retaining ring 137 that is larger than the inlet retaining ring 114, the airflow to the user is less restricted. This, in addition to reducing inhalation noise generated by the user breathing through the breathing mask system in at least some way, also results in a reduced pressure drop across the breathing mask system. From a manufacturability perspective, having an outlet retaining ring 137 that is larger than the inlet retaining ring 114 allows for easier removal of the tool core from the molded part.

[0181] Following the contour of the first retaining ridge 104, the inner surface 103 adjacent to the first retaining ridge 104 is also substantially concave with respect to the transverse axis 107. In an alternative configuration, the inner surface 103 may be substantially convex with respect to the transverse axis 107. Furthermore, the inner surface 103 may be substantially concave with respect to the transverse axis 107 in some areas and substantially convex with respect to the transverse axis in other areas.

[0182] Figure 7 A top view of the frame 100 (relative to the user) is shown. Both the outer surface 102 and the inner surface 103 are concave relative to the user. This is illustrated by the fact that the first retaining ridge 104 is concave relative to the user, as the first retaining ridge 104 of the outer surface 102 is also adjacent to the inner surface 103. This configuration is advantageous because it allows for a reduction in the proximal profile of the breathing mask system. In an alternative configuration, the outlet retainer 137 may be convex or flat in at least one plane. Furthermore, the outlet retainer 137 may include both concave and convex regions in at least one plane.

[0183] The exit retainer surface 124 includes a plurality of seal retaining recesses 130. In the illustrated configuration, the exit retainer surface 124 includes two seal retaining recesses 130. The seal retaining recesses 130 are located near each lateral end of the exit retainer 137. The seal retaining recesses 130 allow the seal 206 to be attached to the frame 100. In the illustrated configuration, the seal 206 is attached to the frame 100 using a clamp attached to the frame 100. The clamp includes raised surfaces corresponding to the seal retaining recesses 130, thereby allowing connection between parts to be manufactured. Some configurations of the exit retainer 137 may include a mechanism for attaching to the seal 206 using a snap-fit ​​mechanism or a friction-fit mechanism. Another embodiment of the frame 100 may include one or more recesses on the exit retainer surface 124 for mating with the seal. Alternatively, instead of using one or more recesses, one or more protrusions may be included on the exit retainer surface 124. These protrusions can interact with corresponding recesses or retaining portions on the seal 206 or the sealing clamp to connect these components together.

[0184] Figure 7A A top view (relative to the user) of an alternative configuration of the frame 100 is shown. In this configuration, a deflector 127 is disposed on an angled surface 135 above the inlet retaining ring 114, for example, also as Figure 5B As shown.

[0185] Figure 8 It shows Figure 1The image shows a bottom view of frame 100 (relative to the user). The exit retaining ring 137 may be concave in at least one plane. At least a portion of the exit retaining ring 137 may be displaced proximally relative to a second portion of the exit retaining ring 137.

[0186] In alternative configurations, the outlet retaining ring 137 can be aligned on a common plane, making it non-concave. In some configurations, this plane is perpendicular to the outlet proximal axis 133. In other words, both the vertical and lateral ends will share a common proximal displacement with the origin of the outlet proximal axis 133.

[0187] Figure 9 It shows Figure 1 The image shows a front view of the frame 100, and identifies the cross-sectional plane 132 that can be cut. This cross-sectional plane is centered relative to the frame 100 and aligned with the vertical axis 105.

[0188] Figure 10 The cross section 10-10 formed when the frame 100 is viewed perpendicular to the cross section plane 132 is shown. The central cross section 134 shows the cross-sectional profile of the frame 100 as observed from the cross section plane 132.

[0189] Figure 10A A central cross-section 134 of the frame 100 is shown. A conduit retaining protrusion 122 protrudes inward from the periphery of the inlet retainer 114. In other words, the lateral and vertical dimensions of the inlet retainer opening 115 are smaller than the corresponding dimensions of the inner surface 116 of the retainer. This dimensional change is a result of the conduit retaining protrusion 122. In other words, the conduit retaining protrusion 122 may form a lip around the interior of the distal end of the inlet retainer 114. This lip may be continuous around the periphery of the inlet retainer opening 115, or may include a protruding section of the periphery and other non-protruding sections of the periphery. The gas delivery conduit 6 can be attached to the frame 100 using an adhesive or a clamp that engages with the conduit retaining protrusion 122. The gas delivery conduit can be positioned adjacent to the conduit retaining protrusion 122 and then adhesively attached to the frame 100. Alternatively, the gas delivery conduit 6 can be removably secured to the frame 100 using a clamp. In some embodiments of the frame 100, the gas delivery conduit 6 may be permanently attached to the frame 100 using clamps or other permanent bonding methods (including but not limited to ultrasonic welding or overmolding). Additionally, in some embodiments, the conduit retaining protrusion 122 may not be included.

[0190] The conduit retaining protrusion 122 may alternatively be located on the inlet retainer surface 118, protruding radially outward from the center of the inlet retainer 114. In other words, the conduit retaining protrusion 122 may form a lip around the outer edge of the inlet retainer 114. In this configuration, the gas delivery conduit 6 may be connected adjacent to the inlet retainer surface, rather than adjacent to the inner surface 116 of the retainer. This lip around the periphery of the inlet retainer 114 may be continuous or discontinuous.

[0191] In the configuration shown, frame 100 is constructed of a rigid polymer. In some configurations, frame 100 may be constructed of any of a variety of polymeric or non-polymeric materials (e.g., nylon 12 or polycarbonate).

[0192] Figure 11 and Figure 12 A non-limiting exemplary embodiment of the breathing mask system 200 is shown, which is substantially similar to Figure 1 A breathing mask system 1. The breathing mask system 200 includes a patient interface 202 and a headband 204. The patient interface 202 includes a seal 206 configured to connect to a previously described frame 100 and a gas delivery conduit 208. The headband 204 and the frame 100 are configured to secure the seal 206 in a stable position below the user's nose.

[0193] The seal 206 is substantially similar to the seal 6 described above, and has a reduced contact area with the user's face compared to more traditional nasal masks that seal around, near, or across the bridge of the nose. This reduced contact area may lead to decreased seal stability, which needs to be offset by the headband 204 to prevent leakage and loss of therapeutic effect. The headband 204 is configured to provide support that counteracts any forces that could break the seal between the seal 206 and the user's face. Forces that could disrupt the seal may include, but are not limited to, the venting force caused by the pressure of the provided CPAP therapy, the tubing drag force, and / or contact between the patient interface 202 and the bedding caused by the user's movement.

[0194] The frame 100 provides the connection between the seal 206 and the headband 204. Figures 11 to 12 The frame 100 is shown to include a gas delivery inlet or inlet retainer 114 through which pressurized air can be supplied to the seal 206 and the patient's airway. Pressurized air is typically supplied to the gas delivery inlet 114 via a conduit or hose (such as gas delivery conduit 208) connected to a CPAP machine or ventilator (not shown).

[0195] headband

[0196] Figures 11 to 17 A non-limiting exemplary embodiment of the headband 204 is shown, which includes a bifurcated headband arrangement. The bifurcated headband 204 includes a plurality of connected straps, including a top strap 212, a pair of opposing side arms 214, a yoke 216, and a rear strap 218. The top strap 212 and the rear strap 218 form the bifurcated arrangement.

[0197] In use, the top bandage 212 is configured to pass over the top of the user's head from one side to the other. In the illustrated configuration, the top bandage 212 may include a forehead bandage positioned above the user's frontal bone. In this configuration, the top bandage 212 is angled in front of the coronal plane 11 passing through the user's head, such as... Figure 12 As shown, the top bandage 212 forms an angle θ between 5° and 45° with the coronal plane 11. In the illustrated embodiment, the top bandage 212 forms an angle of 15° with the coronal plane 11. This angle guides the top bandage 212 toward the patient's forehead, which improves the stability of the headband 204. In other configurations, the top bandage 212 is a top bandage located above the parietal bone, or at or near the junction between the parietal and frontal bones.

[0198] The rear strap 218 wraps around the back of the user's head and, in some configurations, is positioned above the user's occipital bone. However, in other configurations, the rear strap 218 may be positioned higher or lower on the user's head and / or neck.

[0199] The top strap 212 and the rear strap 218 are connected at their ends by one of the side arms 214 to form a forked structure. In use, the top strap 212 and the rear strap 218 encircle the rear portion of the user's head. The rear portion of the user's head that is encircled may include at least a portion of the parietal region and / or the occipital region.

[0200] In the illustrated arrangement, the top strap 212 connects to the side arms 214 on each side of the headband 204 at the connector 224. Each of these side arms 214 extends forward from the connector 224 toward the user's nose in use, then transitions into the yoke 216. In use, the headband 204 is configured such that the connector 224 is positioned above the user's ears. The headband may be positioned in front of or behind the ears depending on the size of the user's head.

[0201] A closed loop formed as a whole

[0202] In the illustrated embodiment, at least some portions of the headband 204 are rigid, semi-rigid, inelastic, or substantially non-stretchable in response to normal or anticipated forces acting on the headband 204. Other portions of the headband 204 are elastic, or stretchable in response to normal or anticipated forces, or at least substantially flexible compared to the other portions.

[0203] In the illustrated configuration, the top strap 212, connector 224, side arm 214, and yoke 216 are rigid, semi-rigid, inelastic, or substantially non-extensible. The top strap 212, side arm 214, and yoke 216 are formed as a single, integrally formed component, which is flat or substantially two-dimensional, such as... Figure 13 As shown. When the free ends of the left portion 220 and the right portion 222 of the top strap 212 are connected to each other, a three-dimensional closed loop is formed by the adjustment mechanism 228. In use, this closed loop is configured to surround at least a portion of the user's head. In the illustrated embodiment, the closed loop surrounds the upper front portion of the user's head, extending upwards from the base of the nose to the parietal bone, and is located in front of the ear. In alternative embodiments, the closed loop may surround a larger or smaller portion of the user's head.

[0204] The use of rigid, semi-rigid, inelastic, or substantially non-extensible materials for the top strap 212, side arms 214, and yoke 216 allows the closed loop formed by these components to effectively transfer force between the patient interface 202 and the user's head. For example, if, during use, the gas delivery catheter is pulled by the user, bedding, or CPAP supply catheter, a force can be applied to the patient interface 202 that pulls the catheter away from the user's face. This force can be translated from the yoke 216 through the side arms 214 to the top strap 216 and then transferred to the user's head to resist the seal 206 from detaching from the user's face by rotation of the seal 206 in the vertical direction.

[0205] The closed loop allows the headband 204 to detach from the patient interface 202 without altering the tightness setting of the top strap 212. This is advantageous because the user does not need to untie and adjust the headband 204 each time it is removed from the patient interface 202, and then re-tighten it to the correct tightness. This saves time and makes it easier for the user to install the headband. The closed loop arrangement also provides a single connection point between the headband 204 and the patient interface 202.

[0206] In other words, the integrally formed components that form the closed loop are rigid, semi-rigid, inelastic, or substantially non-extensible. In the illustrated embodiment, the top strap 212, side arms 214, and yoke 216 are integrally formed from a plastic material that forms a plastic core and covers a textile shell, wherein the textile shell is permanently bonded to the plastic core. The plastic core provides the required structure in the headband 204, while the textile shell provides a soft and comfortable finish for contact with the user. In the illustrated embodiment, the textile shell is a circular knitted tube. In alternative embodiments, the textile shell may comprise several layers of textile cut and connected along their edges; or any other tubular textile, which may include, but is not limited to, woven or braided tubes. In some embodiments, at least a portion of the integrally formed top strap 212, side arms 214, and yoke 216 is formed by an internal molding process, an example of which is described in the applicant's application PCT / NZ 2015 / 050149, the entire contents of which are incorporated herein by reference. "Internal molding" involves forming a component as a plastic core and a textile shell as a single, integral structure by applying molten plastic into the textile shell. Straps or any other components that have been "internal molded" are formed by applying molten plastic into the textile shell.

[0207] Figure 13 The illustrated embodiment of the headband 204 has a top strap 212 and side arms 214 including a soft edge 250. The soft edge 250 is configured to extend along one or both of the longitudinal edges of the top strap 212 and the side arms 214. The soft edge is formed by a longitudinal edge portion of a textile shell that protrudes from the edge of a plastic core and is not filled by the plastic core. The soft edge provides a cushioning edge that can improve user comfort by softening any contact between the edges of both the rigid, semi-rigid, inelastic, or substantially non-extensible top strap 212 and side arms 214 and the user's head. This may be particularly advantageous for the lower edge of the side arms 214, which is located above the user's ears during use.

[0208] In alternative embodiments, the closing loop can be formed of any material that provides suitable rigidity, inelasticity, or non-stretchability. These materials may include, but are not limited to, thermoplastics and silicones. In some embodiments, the material may or may not have a textile outer shell.

[0209] Top strap

[0210] In the illustrated embodiment, the top strap 212 includes two strap portions, namely a left portion 220 and a right portion 222. The left portion 220 and the right portion 222 are separate from each other and have a free end and a fixed end. The free end is configured to be adjustablely connected via an adjustment mechanism 228. The fixed end is configured to extend at an angle to the side arm 214 at the connection 224.

[0211] Adjustment mechanism 228 is configured to provide a way to adjust and secure the top strap 212 to a desired adjustable length, thereby adjusting the size and / or tightness setting of the headband 204. Adjusting the length of the top strap 212 can limit the positioning of the side arm 214 relative to the top of the user's ear during use. Shortening the length of the top strap 212 can position the side arm 214 higher above the user's ear, thereby avoiding contact between the side arm 214 and the user's ear. This can improve user comfort, as contact between the side arm 214 and the top of the user's ear can create irritation or pressure points, which may lead to pressure sores over time.

[0212] Figure 13 The adjustment mechanism 228 is shown in the disengaged position. The free end of the left portion 220 includes a guide ring 230 and a plurality of holes 232 spaced apart along the length of the strap. These holes 232 extend through the thickness of the top strap 212. The free end of the right portion 222 includes a point or post 234 protruding from the inner surface 236 of the strap.

[0213] The guide ring 230 includes a ring structure that forms an opening at the end of the left portion 220. The free end of the right portion 222 is configured to pass through the opening formed by the guide ring 230. Therefore, the left and right portions 220 can slide relative to each other to change the overlap distance between them, thereby changing the length of the top strap 212. When the adjustment mechanism 228 is not engaged, the guide ring 230 also maintains the connection between the left and right portions 220. This improves usability. The guide ring 230 is angled away from the inner surface 236 such that the opening is at least partially offset from the thickness of the strap. This allows the right portion 222 to pass through the guide ring 230 and overlap with the left portion 220 without the left portion 222 needing to be bent or deformed.

[0214] Post 234 is configured to pass through any of the holes 232. For example... Figure 14As shown, post 234 includes a rod 238 and a head or cap 240. Post 234 shown is generally T-shaped; however, other shapes, such as a cylindrical rod 238 and a disc-shaped or spherical head 240, may also be used. The size and shape of the holes 232 are determined and / or these holes are otherwise configured to allow the head 240 of post 234 to pass through, at least in response to normal or anticipated forces, and to hold post 234 in place once the head has passed through the holes 232. However, post 234 may be intentionally removed from holes 232 to allow the left portion 220 and right portion 222 of the top strap 212 to separate, thereby allowing for changes in the size of headband 204. Passing post 234 through holes 232 can be achieved by deforming one or both of post 234 and holes 232. That is, the head 240 of post 234 may be bent or otherwise deformed, and the hole 232 may be stretched or enlarged to allow the head 240 of post 234 to pass through. In alternative embodiments, multiple columns may be present.

[0215] In alternative embodiments, the adjustment mechanism 228 may include any other suitable means of adjustingly connecting the free end of the top strap 212, such as, but not limited to, hook and loop fasteners or buckles.

[0216] In an alternative arrangement, the inner surface 236 of the left portion 220 may include the hook portion of the hook-and-loop fastener, and the outer surface 242 of the right portion 222 may include the loop portion of the hook-and-loop fastener. This arrangement can also be reversed. In some configurations, the material of the top strap 212 may define the loop portion of the hook-and-loop fastener. In other words, the loop portion may not be a discrete element of the top strap 212.

[0217] Side arm

[0218] The opposing side arms 214 are configured to attach the yoke 216 to the top strap 212 on each side of the user's face during use. This arrangement allows rotational forces applied to the patient interface 202 to be translated from the yoke 216 to the top strap 212 and the user's head in order to resist rotation of the seal 206 relative to the user's face.

[0219] The side arm 214 includes elongated straps shaped to cross the user's cheek and curve towards the temple above the ear during use. This curve allows the side arm 214 to avoid the eyes, providing an unobstructed view and improving user comfort. The curve can also follow the line of the user's cheekbone, ensuring that the contact between the side arm 214 and the user's cheek transmits force away from the patient interface 202, thus maintaining an uninterrupted seal with the user's face.

[0220] The side arm 214 further includes a buckle 226 integrally formed at the free end of each side arm 214. In use, the free end of the side arm 214 extends rearward beyond the connection 224 with the top strap 212, and the buckle 226 is positioned above or behind the user's ear.

[0221] Buckle 226 includes an extension of the free end of side arm 214 and an opening extending through the thickness of side arm 214. This opening is configured to receive rear strap 218. In alternative embodiments, buckle 226 may include a hook or any other geometry suitable for adjustingly fastening the rear strap 218.

[0222] The side arm 214 is flexible in a generally horizontal plane (when worn) toward and away from the user's face to accommodate different face sizes, but is relatively inflexible in a generally vertical plane. The side arm 214 shown is solid, but other forms of the side arm may include one or more openings or cutouts extending along its longitudinal direction to increase its flexibility toward and away from the user's face, while retaining its relative inflexibility in a generally horizontal plane (when worn). The vertical inflexibility of the side arm 214 allows it to transmit forces that can be applied to the patient interface 202 (such as, but not limited to, blow-off forces or hose drag / pull forces) to the top strap 212 and the rear strap 214. This can help reduce the likelihood of the seal 206 detaching from the user's face and interrupting the delivery of therapy.

[0223] yoke

[0224] In use, the yoke 216 is symmetrical about the sagittal plane and, when viewed from above, comprises a generally "U"-shaped structure, such as... Figure 16 As shown in the image. The yoke 216 follows the curvature of the frame 100 and is configured to connect the patient interface 202 to the headband 204 via the frame 100. The yoke 216 includes a central bridging portion 244 and a pair of laterally rearward portions 248 extending laterally rearward from each side of the central bridging portion 244. The yoke 216 provides a single connection between the headband 204 and the frame 100, independent of any other feature of the frame 100. This allows the headband 204 to be disconnected from the frame without obstructing or disconnecting any other portion of the patient interface 202.

[0225] The yoke 216 is configured to provide a connection between the frame 100 and the headband 204, which supports the patient interface 202 relative to the user in both the vertical and horizontal directions when the breathing mask 200 is worn. By supporting the patient interface 202 in both the vertical and horizontal directions, rotation of the seal 206 relative to the user's face is reduced, thereby reducing leakage.

[0226] The central bridging portion 244 is shaped such that it fits within the recessed channel 106 of the frame 100 (as described above). The central bridging portion 244 is configured to be temporarily or permanently connected to the recessed channel 106 by means of, but not limited to, snap-fit ​​connection, friction fit connection, clamping mechanism, adhesive or welding. The central bridging portion 244 bends above the inlet retaining ring 114 of the frame 100 and then transitions into the laterally rearward portion 248.

[0227] The rear lateral portion 248 forms an integrally formed transition between the central bridging portion 248 and the side arm 214. When the breathing mask 200 is worn by the user, the rear lateral portion 248 is positioned on the side of the central bridging portion 244 and bends around the frame 100 in a rearward direction.

[0228] like Figure 16 As shown, the height H1 of the central bridging portion 244 is less than the height H2 of the lateral rear portion 248 of the yoke 216. To minimize the size of the frame 100, height H1 is less than height H2. Height H2 is greater than height H1 to provide the desired horizontal structure in the vertical direction to prevent rotation of the patient interface 202 relative to the user's face. H1 can be between 1 mm and 12 mm, or between 4 mm and 7 mm. In the illustrated embodiment, H1 is 5.5 mm. H2 can be between 5 mm and 16 mm, or between 8 mm and 13 mm. In the illustrated embodiment, H2 is 12.5 mm.

[0229] The side arm 214 can continue from the lateral rear portion 248 at a height equal to or greater than H2. In some embodiments, the height of the side arm 214 increases in the direction of movement away from the yoke 216. The transition between H1 and H2 occurs between the central bridging portion 244 and the lateral rear portion 248. The lateral rear portion 248 is configured to contact the frame 100 until the height has fully transitioned to height H2. This configuration allows the frame 100 to provide structural support for the yoke 216 at its maximum height, ensuring that no part of the yoke 216 or the side arm 214 is unsupported and thus could form a weak point. This allows forces to be translated from the frame 100 through the yoke 216 to the side arm 214 without passing through weak points that could cause the side arm 214 or the yoke 216 to twist or bend in the vertical direction, thereby allowing the patient interface 202 to rotate. In some embodiments, the height of the side arm 214 is no greater than 16 mm in order to provide a minimal breathing mask.

[0230] exist Figure 16As can be seen, the soft edges 250 of the side arms 214 are transitioned out, so that they are not present in the yoke 216. This can provide an improved connection between the yoke 216 and the frame 100 by providing rigid, semi-rigid, inelastic, or substantially non-extensible edges, which can be engaged by the recessed channels 106 of the frame 100. The soft edges 250 are not needed on the edges of the yoke 216 because the yoke edges are unlikely to come into contact with the user and cause discomfort or irritation. The soft edges 250 can be transitioned out, thereby minimizing the size of the yoke 216; therefore, the size of the frame 100 can be minimized to provide a less obtrusive breathing mask system 200.

[0231] Figure 17 In the illustrated embodiment, the wall thickness T1 of the rearward portion 248 of the yoke 216 in the direction perpendicular to the inner surface 236 is greater than the wall thickness T2 at the center of the yoke 216 and the side arm 214. This increased thickness provides enhanced structure at the outermost portion of the yoke 216 that contacts the frame 100. This allows forces to be effectively translated from the side arm 214 to the frame, thereby minimizing vertical rotation of the patient interface 202. The thickness T1 of the rearward portion can be between 1 mm and 4 mm. In the illustrated embodiment, the thickness T1 is 2.9 mm. The thickness T2 of the central bridging portion 244 and the side arm 214 is between 0.5 mm and 3 mm. In the illustrated embodiment, T2 is 2.1 mm.

[0232] The reduced thickness T2 of the side arm 214 relative to the larger wall thickness T1 of the lateral rear portion 248 of the yoke 216 facilitates the horizontal flexibility of the side arm 130 relative to the yoke 216 (when worn). This allows the side arm 214 to bend horizontally to accommodate different facial geometries when the breathing mask 200 is worn by the user, while providing stability in the vertical direction.

[0233] Rear strap

[0234] The rear strap 218 includes an extension strap that extends between and around the buckles 226 of the side arms 214. The end of the rear strap 218 is adjustablely fastened through openings in the buckles 226, allowing for adjustment of its length. Adjusting the length of the rear strap 218 further adjusts the overall size of the headband 204 to fit each individual user.

[0235] In the illustrated configuration, the rear strap 218 is elastic or stretchable. This arrangement allows the rear strap 218 to stretch to adjust the circumferential length of the headband 204. The amount of stretching of the rear strap 218 can be limited, and thus the length of the rear strap 218 can also be adjustable, as previously described. In some configurations, the adjustment of the circumferential length is preferably made at the back of the user's head, so that it is less likely to lengthen in response to blow-out forces. The rigid, semi-rigid, inelastic, or substantially non-stretchable nature of the connecting portions 224 and sidewalls 214 located on the side and front portions of the user's head helps to maintain the desired circumferential length of the headband 204, even though the rear strap 218 is elastic. In some cases, the friction between these portions of the headband 204 and the side and front portions of the user's head inhibits the headband 204 from moving or lengthening in response to blow-out forces. However, in other arrangements, the rear strap 214 may be rigid, semi-rigid, inelastic, or substantially non-extendable, and in such cases, it may be adjustable in length.

[0236] In the illustrated embodiment, the rear strap 218 comprises a length of laminated textile and foam, such as, but not limited to, [materials not specified in the original text]. The back strap is elastic, allowing it to be stretched to allow the headband 204 to be pulled over the user's head without adjusting the length of the back strap 218. This improves ease of use. In alternative embodiments, the back strap may comprise any suitable textile or fabric material.

[0237] The rear strap 218 has two lateral ends 244, which are configured to pass through the buckle 226 and fold back onto themselves. Figure 12 (As shown in the diagram), where they can be fastened in a user-defined position. The lateral ends 226 of the rear strap 218 can be fastened to the outer surface of the rear strap 218 by fastening devices (such as, but not limited to, hook and loop fasteners). The overlap between the folded lateral ends 244 and the remainder of the rear strap 218 determines the length of the rear strap 218 and the size of the headband 204. In the illustrated embodiment, the lateral ends 244 of the rear strap 218 include hook and loop fasteners (such as, but not limited to, hook and loop fasteners) for fastening. The fastener tab is in the form of a hook component of the brand's hook-and-loop fastener. This fastener tab is configured to fasten to a loop component on the outer surface of the rear strap 218. In the illustrated embodiment, the outer surface of the rear strap 218 comprises the material providing the loop component of the hook-and-loop fastener. In an alternative embodiment, this arrangement of the hook-and-loop fastener can be reversed, such that the hook component is located on the outer surface of the rear strap 218.

[0238] Alternative headband examples

[0239] Figure 18 and Figure 19 Another non-limiting exemplary embodiment of headband 304 is shown. For the purposes of this specification, features of this embodiment that are substantially similar to those of the previous embodiment of headband 204 are assigned the same numbers plus the resulting reference numerals. For example, headband 204 becomes headband 304 in this embodiment. For brevity, only those features that are significantly different from the previous embodiment are described in detail herein. It should be understood that all other features are substantially as described with respect to headband 204.

[0240] The headband 304 includes a top strap 312, a pair of opposing side arms 314, a yoke 316, and a rear strap 318. As in the previous embodiments, the top strap 312, side arms 314, and yoke 316 are rigid, semi-rigid, inelastic, or substantially non-extensible and are formed as a single, integrally formed component. This single, integrally formed component can be arranged to form a closed loop that surrounds the upper front portion of the user's face during use. The top strap 312, side arms 314, and rear strap 318 are substantially identical to the top strap 212, side arms 214, and rear strap 218 as described above. As shown, the rear strap 318 can extend between and connect to the buckles 326 of the side arms 314. One or both ends of the rear strap 318 may include gripping tabs 319, which advantageously allow the user to more easily grip one or both ends of the rear strap 318 to adjust and / or secure the rear strap 318. The top strap 312 may be adjusted via an adjustment mechanism 328.

[0241] In this embodiment, the yoke 316 is configured to provide a connection between the headband 304 and the patient interface (not shown, but may be similar to the patient interface 202). In use, the yoke 316 is positioned about the sagittal plane ( Figure 19 (As shown in the diagram) Symmetrical and includes a ring structure formed by an upper bridging portion 350 and a lower bridging portion 352, which are connected at their lateral ends by the front ends of each of the side arms 314. The upper bridging portion 350 and the lower bridging portion 352 are configured to be removably connected to a frame (not shown, but may be similar to frame 100) around an inlet retainer or frame connector. The upper bridging portion 350 and the lower bridging portion 352 are curved such that the ring structure they form is continuous and defines an opening configured to surround the inlet retainer. This curved shape can be configured to fit within the circumference of the frame to reduce the overall size of the patient interface.

[0242] The upper bridging portion 350 and the lower bridging portion 352 are configured to resist rotational forces that can be applied to the patient interface. The upper bridging portion 350 and the lower bridging portion 352 provide two paths through which forces can be transmitted from the frame to the headband 300; this can evenly distribute the rotational force so that rotation does not occur due to deviation in the upward or downward direction.

[0243] Alternative framework implementation

[0244] Figure 20 Another non-limiting exemplary embodiment of a breathing mask assembly 400 is shown. The breathing mask assembly 400 includes a patient interface 402 and a headband 404. The patient interface 402 includes a seal 406 configured to connect to a frame 410 and a gas delivery conduit 408. In some embodiments, the frame 410 has a reduced or smaller overall profile compared to the frame 100. The headband 404 and the frame 410 are configured to secure the seal 406 in a stable position below the user's nose during use.

[0245] The seal 406 may be substantially similar to the seal 6 described above, and has a reduced contact area with the user's face compared to a more conventional nasal mask that seals around, near, or across the bridge of the nose. This reduced contact area may result in decreased seal stability, which may need to be offset by the headband 404 to prevent leakage and loss of therapeutic effect. The headband 404 is configured to provide support to counteract forces that could break the seal between the seal 406 and the user's face. Forces that could disrupt the seal may include, but are not limited to, the venting force caused by the pressure of the provided CPAP therapy, the tubing drag force, and / or contact between the patient interface 402 and the bedding caused by the user's movement.

[0246] Figure 21-23B as well as Figure 26A-32B The frame 410 shown provides a connection between the seal 406 and the headband 404. Similar to frame 100, frame 410 has an outer surface 412, an inner surface 413, and a fluid path 415 extending therethrough, such as... Figure 21-23B As shown. An outer surface 412 and an inner surface 413 extend from a first lateral edge 422 to a second lateral edge 424. The outer surface 412 faces away from the user during use and acts as an interface between the frame 410, a headband (such as headband 404), and a gas delivery conduit (such as gas delivery conduit 408). The inner surface 413 faces the user during use and can contact a seal 406 and / or a clamp connected to the seal 406. During use, the gas delivery conduit 408 is coupled to the frame 410 such that the gas delivery conduit 408 is in fluid communication with a fluid path 415.

[0247] The outer surface 412 includes a recessed surface 426 and a raised surface 428. In some embodiments, a portion of the headband 404 (e.g., a yoke 416) may be positioned adjacent to the recessed surface 426 during assembly. In the illustrated embodiment, the recessed surface 426 is located above the raised surface 428 and / or adjacent to the top edge of the frame 410, while the raised surface 428 is below the recessed surface 426 and / or adjacent to the bottom edge of the frame 410. An inlet retainer 430 protrudes outward from the outer surface 412 (away from the user in use). The inlet retainer 430 surrounds the fluid path 415. In the illustrated embodiment, the boundary between the recessed surface 426 and the raised surface 428 is partially defined by the inlet retainer 430. The inlet retainer 430 includes an inner inlet retainer surface 432 (which defines the fluid path 415) and an inlet retainer surface 434 (located on the outer side of the inlet retainer 430). In some embodiments, the inlet retainer surface 434 may be considered as part of or partially defining the outer surface 412. In the illustrated embodiment, the inlet retainer 430 includes a conduit retaining protrusion 436. Figure 22 (As shown in the diagram). The inlet retaining ring 430 may include one or more deflection orifices 438.

[0248] The exit retaining ring 440 protrudes inward from the inner surface 413 (facing the user in use). The exit retaining ring 440 has an exit retaining ring surface 444, which in some embodiments may be considered part of or partially define the inner surface 413. The exit retaining ring 440 may include one or more seal retaining recesses 446. The seal retaining recesses 446 allow interaction and / or connection between the frame 410 and the seal 406. In some embodiments, the seal retaining recesses 446 allow interaction and / or connection between the frame 410 and a clamp connected to the seal 406. In the illustrated embodiment, the exit retaining ring surface 444 includes the seal retaining recesses 446.

[0249] The fluid path 415 is defined or formed by an inlet retaining ring 430 and an outlet retaining ring 440. In use, a gas delivery conduit 408 is coupled to the inlet retaining ring 430, and a seal 406 is coupled to the outlet retaining ring 440. Gas can be delivered from the gas delivery conduit 408 through the fluid path 415 (i.e., through the inlet retaining ring 430 and the outlet retaining ring 440) to the seal 406 for delivery to the user.

[0250] In the illustrated embodiment, the inlet retaining ring 430 may be elliptical and have a major axis 113 and a minor axis 111. In some embodiments, the inlet retaining ring 430 may be circular, triangular, "D"-shaped, or other shapes. In the illustrated embodiment, the frame 410 is symmetrical about the minor axis 111 or the vertical axis 105. In the illustrated embodiment, the principal dimension D of the opening defined by the inlet retaining ring 430 is... 主要 ( Figure 23B The secondary dimension D of the opening (shown in the image) is 21.9mm or approximately 21.9mm. 次要 It is 16.7mm or approximately 16.7mm. In other words, the ratio between the major and minor dimensions is 1.31:1 or approximately 1.31:1.

[0251] In the illustrated embodiment, the lateral dimension (or width) W of the frame 410 is... Figure 23B The lateral dimension (shown in the diagram) is 49.3 mm or approximately 49.3 mm. The ratio between the principal dimension of the opening defined by the inlet retaining ring 430 and the lateral dimension W of the frame 410 is therefore 1:2.25 or approximately 1:2.25. The lateral dimension of the frame 410 can be selected to optimize or enhance the functionality of the frame 410 when assembled with the seal 406 and the headband 404. In some embodiments, the lateral dimension of the frame 410 can range from 30 mm (or approximately 30 mm) to 75 mm (or approximately 75 mm).

[0252] In the illustrated embodiment, the vertical dimension (or height) H of the frame 410 is... Figure 23B The opening (shown in the diagram) is 28.0 mm or approximately 28.0 mm. The ratio between the secondary dimension of the opening defined by the inlet retaining ring 430 and the vertical dimension of the frame 410 is therefore 1:1.68 or approximately 1:1.68. One consideration in selecting the vertical dimension of the frame 410 is the area required to maintain an effective connection between the frame 410 and the headband 404, as described herein, for the recessed surface 426 and / or the headband retaining feature. The vertical dimension of the frame 410 can be selected to provide a structure large enough to allow the headband 404 to be effectively attached to the frame 410, and / or to provide the sufficient structural and rotational integrity required for the seal 406. In some embodiments, the vertical dimension of the frame 410 can range from 20 mm (or approximately 20 mm) to 50 mm (or approximately 50 mm). This vertical dimension can be varied to accommodate different seal sizes, headband profiles, and / or headband attachment methods or mechanisms.

[0253] In the illustrated embodiment, the proximal dimension (or thickness) T( of frame 410) Figure 26B (As shown in the image) is 17.05mm or approximately 17.05mm. For example... Figure 26A and Figure 26B As shown in the side view, the entire periphery or distal end of the inlet retainer 430 (in other words, the edge of the inlet retainer 430 furthest from the user in use) is not aligned with the shown vertical axis 105. The vertical extremes of the inlet retainer 430 (in other words, the top and bottom extremes) intersect the vertical axis, but the central portion of the inlet retainer 430 (in other words, the side or lateral extremes) is displaced towards the proximal side (or towards the user in use). In other words, when viewed from the side (e.g.) Figures 26A-26B As in the example, the periphery of the inlet retainer 430 is concave to the distal side (or concave away from the user in use). This concave profile advantageously allows for a reduction in the material requirements of the frame 410. In some embodiments, the elliptical shape of the inlet retainer 430 and / or the offset vertical and lateral ends of the distal end of the inlet retainer 430 provide beneficial performance when a gas delivery conduit (such as gas delivery conduit 408) is coupled to the inlet retainer 430. For example, if the gas delivery conduit 408 is removably coupled to the inlet retainer 430, for example via a press fit, snap fit, or other connection engaging with the conduit retaining protrusion 436, it may be difficult to unintentionally remove the gas delivery conduit 408 when a force is applied axially (in the axial direction of the inlet retainer 430 and / or the gas delivery conduit 408). Therefore, the elliptical shape and / or concave distal end of the inlet retainer 430 can suppress unintentional removal of the gas delivery conduit 408. However, if the gas delivery conduit is twisted about the axial axis of the inlet retainer 430, the gas delivery conduit can be more easily removed from the frame 410, or can be removed from the frame with less force.

[0254] Frame 410 may include various headband retaining features. These retaining features are used to attach frame 410 to headband 404, such as... Figure 25 As shown. In Figure 21-23B In the illustrated embodiment, frame 410 includes two retaining features 450 located in a recessed surface 426. More or fewer retaining features 450 are also possible. As shown, each retaining feature 450 is laterally displaced relative to or spaced laterally from the vertical axis, and one of the retaining features 450 is located on each side of the vertical axis. In the illustrated embodiment, the retaining feature 450 is a circular hole. In some embodiments, the retaining feature 450 is elliptical, rectangular, or "D"-shaped (e.g., as shown in the figure). Figure 24C(As shown) Holes of the shape or other shapes. In some embodiments, the two retaining features 450 are different from each other. The different shapes of the right and left headband retaining features 450 can help guide the user to properly attach the headband 404 to the frame 410. In some embodiments, the headband retaining features 450 have anti-rotation shapes and / or features. The headband 404 may include protrusions corresponding to the retaining features 450 and are designed to engage with the retaining features 450. These protrusions may be secured to the retaining features 450 and the frame 410 via snap-fit ​​or other suitable means. In some embodiments, the retaining feature 450 may be a structure that protrudes outward from the recessed surface 426, for example, as shown. Figure 24D As shown. In some such embodiments, the headband 404 may include corresponding holes for receiving retaining features 450. In the illustrated embodiments, each of the retaining features 450 is a circular protrusion with a central channel extending between the retaining features 450 and / or dividing the retaining feature into two semi-circular or generally semi-circular sides or portions. These protrusions may be secured to correspondingly sized holes in the headband 404 via snap-fit ​​or other suitable means. In some embodiments, the retaining feature 450 may include one or more magnets or magnetic materials for attracting one or more magnets or magnetic materials in the headband 404.

[0255] As described above, in the illustrated embodiment, the frame 410 includes two retaining features 450. Including two retaining features 450 and / or using circular retaining features 450 advantageously allows for convenient putting on and taking off of the headband 404 from the frame 410. Figure 24A As shown, the first of the retaining features 450 can be used to connect the frame 410 and the headband 404 at an angle. The frame 410 can then rotate about the first retaining feature 450, allowing the second of the retaining features 450 to be connected to the headband 404, as shown. Figure 24B As shown.

[0256] In the illustrated embodiment, the inlet retaining ring 430 or the inlet retaining ring surface 434 is due to the angle θ of the angled surface. A The angle is such that the diameter of the base of the inlet retaining ring 430 closest to the user during use is larger than the diameter of the periphery of the inlet retaining ring 430 furthest from the user during use, such as... Figure 28 and Figure 29C As shown. The inlet retainer 430 can resemble a hollow truncated cone. The angle of the inlet retainer 430 causes or allows air to be guided away from the user's face through the deflection orifice 438 (generally or substantially perpendicular to the angled inlet retainer 430 or inlet retainer surface 434). This advantageously prevents or reduces the likelihood of the user feeling dragged due to airflow passing through the deflection orifice 438 and / or being entrained.

[0257] The angle of the first angled surface can be defined as the angle between the top (or upper vertical extreme) of the inlet retainer 430 or the inlet retainer surface 434 and the following axis: this axis is parallel to the proximal axis and is located at the intersection of the inlet retainer 430 and the outer surface 412 or recessed surface 426 of the frame 410, such as... Figure 28 As shown. The angle θ of the second angular surface. A2 This can be defined as the angle between the lateral side of the inlet retaining ring 430 or the surface 434 of the inlet retaining ring and the following axis: this axis is parallel to the proximal axis and is located at the intersection of the inlet retaining ring 430 and the outer surface 412 or raised surface 428 of the frame 410, such as... Figure 29C As shown. In some embodiments, the angle of the angled surface can be in the range of approximately 10° to approximately 15°. In the illustrated embodiment, the angle of the first angled surface is approximately 10°, the angle of the second angled surface is approximately 15°, and the angle of the angled surface transitions from approximately 10° to approximately 15° between the top and side of the inlet retaining ring 430. In some embodiments, the angle of the angled surface can be constant around the entire inlet retaining ring 430. In some embodiments, the angle of the angled surface can vary around the inlet retaining ring 430. In some embodiments, the angle of the angled surface can be in the range of approximately 0° to approximately 90°, for example, approximately 0°, approximately 45°, or approximately 90°.

[0258] In the illustrated embodiment, each deflector 438 is offset or spaced apart by an equal distance from the distal end of the inlet retainer 430. In other words, the arrangement of the deflectors 438 follows the contour of the distal end or periphery of the inlet retainer 430, and one or more deflectors 438 are located at or near the vertical extreme (top or bottom) of the inlet retainer 430 during use, which is farther from the user than one or more deflectors 438 located at or near the lateral side of the inlet retainer 430. In some embodiments, the arc connecting one or more deflectors 438 is parallel or substantially parallel to the periphery of the inlet retainer 430. Maintaining a constant and controlled distance between the deflectors 438 and the periphery of the inlet retainer 430 allows for better and easier control of noise generated by the gas flowing through the deflectors 438. The distance between the deflectors 438 and the periphery of the inlet retainer 430 can be selected to reduce or minimize noise generated by the gas flowing through the deflectors 438. In the illustrated embodiment, the deflection orifice 438 is positioned 3.1 mm or approximately 3.1 mm from the periphery of the inlet retaining ring 430. In the illustrated embodiment, the deflection orifice 438 is located at or approximately at the midpoint of the length of the inlet retaining ring 430.

[0259] In the illustrated embodiments, such as Figure 26DAs shown, a deflection orifice 428 is disposed around or within a portion of the inlet retaining ring 430. The portion of the inlet retaining ring 430 including the deflection orifice 428 can be determined by an exhaust angle θ. E The exhaust angle is defined relative to the origin centered at the intersection of the vertical axis 105 and the horizontal axis 107 of the inlet retainer ring 430, as shown in the figure. In some embodiments, the exhaust angle and / or the deflector orifice 428 can span from approximately 4:00 to approximately 8:00 (as on a clock face). In some embodiments, the exhaust angle and / or the deflector orifice 428 can span from approximately 5:00 to approximately 7:00, or from approximately 3:00 to approximately 9:00. In some embodiments, the exhaust angle can be approximately 220°, approximately 218°, in the range of approximately 180° to approximately 270°, in the range of approximately 190° to approximately 260°, in the range of approximately 200° to approximately 250°, in the range of approximately 210° to approximately 240°, or in the range of approximately 220° to approximately 230°. In some embodiments, the exhaust angle can be 360°. In other words, in some embodiments, the deflection orifice 428 may span the circumference of the inlet retainer 430 or completely surround the inlet retainer.

[0260] like Figure 26C As shown, in the illustrated embodiment, the deflection orifice 438 extends through the inlet retainer 430 perpendicular to or substantially perpendicular to the inlet retainer surface 434 and / or the inlet retainer inner surface 432. In some embodiments, such as Figure 26C As indicated by the dashed line, the deflection orifice 438 can extend through the inlet retaining ring 430 at an angle θ relative to the vertical. The angle θ can range from approximately ±10° to approximately ±45°, for example, ±10°, ±25°, or ±45°. As shown, the deflection orifice 438 is oriented at a positive angle such that it extends closer to the periphery of the inlet retaining ring 430 on the inlet retaining ring surface 434 than on the inlet retaining ring inner surface 423. An angle greater than or equal to 0 can advantageously guide gas away from the user through the deflection orifice 438 during use.

[0261] like Figure 27B As shown, the outlet retaining ring 440 has a major axis 119 and a minor axis 121. In the illustrated embodiment, the outlet retaining ring 440 has a "D" shape. The major axis dimension D of the outlet retaining ring 440 is... o-major The size of the opening is defined by the nearest side end or edge of the outlet retainer 440 along the main axis 119 at the location where the opening has the maximum lateral dimension. In some embodiments, the outlet retainer 440 may have a circular, triangular, or other shape. The minor axis dimension D of the outlet retainer 440 is... o-minor This refers to the dimension of the opening along the minor axis 121, which, in the illustrated embodiment, is parallel to and / or aligned with the vertical axis, such as... Figure 27AAs shown. Figure 27A As shown, the vertical and horizontal axes intersect at the origin, which is located at or corresponds to the center of the opening in the inlet retaining ring 430. In the illustrated embodiment, the outlet long axis corresponds to or is located at the same position as the horizontal axis. In some embodiments, the outlet long axis may be shifted vertically or spaced apart from the horizontal axis. In other words, in some embodiments, the center of the opening in the inlet retaining ring 430 is offset from the center of the opening in the outlet retaining ring 440.

[0262] In the illustrated embodiment, the major axis dimension D of the outlet is... o-major The export short shaft dimension D is 25.9mm or approximately 25.9mm. o-minor It is 20.7mm or approximately 20.7mm. In other words, the export long axis dimension D o-major With the export short shaft dimension D o-minor The ratio between them is 1.25:1 or approximately 1.25:1. In the illustrated embodiment, the opening of the outlet retaining ring 440 is larger than the opening of the inlet retaining ring 430.

[0263] In some embodiments, the exit retaining ring 440 or a portion thereof (e.g., the edge 441 of the exit retaining ring in the illustrated embodiment) is a different color compared to the rest of the frame 410. In some embodiments, the majority of the frame 410 may be transparent, and the exit retaining ring 440 or a portion thereof may be a transparent blue. In some embodiments, the majority of the frame 410 may be transparent, and the exit retaining ring 440 or a portion thereof may be opaque. In some embodiments, the majority of the frame 410 may be opaque, and the exit retaining ring 440 or a portion thereof may be transparent. The different color (and / or transparency) of the exit retaining ring 440 or a portion thereof can advantageously provide an indication to the user that the exit retaining ring 440 is designed to engage with another component of the assembly (e.g., the clamp of the seal 406) in use. Figure 29BAs shown, the proximal edge 441 extending to a specific depth of the exit retaining ring 440 can have a different color. In some embodiments, different colors can be produced using a pad printing process. In some embodiments, the inlet retaining ring 430 or a portion of the inlet retaining ring 430 is a different color compared to other portions of the frame 410. In some embodiments, the exit retaining ring 440 and / or the inlet retaining ring 430 can be made of at least one material with properties different from the material of most or one or more other portions of the frame 410. For example, the exit retaining ring 440 can be made of at least one material with properties different from the material of the inlet retaining ring 430. In such embodiments, the frame 410 can be formed using, for example, two-shot molding, co-molding, or overmolding processes. In some embodiments, the frame 410 can be formed using two-shot molding, co-molding, or overmolding processes even if the frame 410 is made of a single material and / or the material of the inlet retaining ring 430 is indistinguishable from the material of the exit retaining ring 440.

[0264] Figure 32A Showing along Figure 31 The section view is taken from line 32A-32A. The cutting line is centered relative to frame 410 and aligned with the vertical axis. Figure 32B Showing Figure 32A A 2D view of the cross-section. The thickness of frame 410 or the thickness of individual portions of frame 410 can be selected to provide sufficient rigidity for frame 410 in use while reducing or minimizing the weight and / or profile of frame 410. In some embodiments, the recessed surface 426 (or the frame 410 in the region of the recessed surface 426) has a thickness of 1.5 mm or approximately 1.5 mm. rs In some embodiments, the thickness t of the inlet retaining ring 430 ic The thickness is 1.46 mm or approximately 1.46 mm. In some embodiments, the catheter retaining protrusion 436 protrudes inwardly from the inner surface 432 of the inlet retainer ring by 0.5 mm or approximately 0.5 mm. In the illustrated embodiment, the catheter retaining protrusion 436 extends around the entire periphery of the inlet retainer ring 430. In some embodiments, the thickness t of the outlet retainer ring 440 is... oc The thickness is 1.5 mm or approximately 1.5 mm. Other thicknesses are also possible for the inlet retaining ring 430, the recessed surface 426 (or the frame 410 in the area of ​​the recessed surface 426), and / or the outlet retaining ring 440. In some embodiments, the frame 410 is made of nylon 12, or comprises said nylon. When the inlet retaining ring 430, the recessed surface 426 (or the frame 410 in the area of ​​the recessed surface 426), and / or the outlet retaining ring 440 have a thickness in the range of 0.6 mm or approximately 0.6 mm to 2 mm or approximately 2 mm or greater, changing the properties of the compound can allow the frame 410 to exhibit the same or similar rigidity.

[0265] Alternative headband examples

[0266] Figures 33 to 34 An exemplary embodiment of a headband 404 that can be used with frame 410 is shown. In the illustrated embodiment, headband 404 has a forked configuration. Headband 404 may be similar to headband 204 in some respects. Features of headband 404 that are identical or similar to corresponding features of headband 204 are indicated by reference numerals that are the same as those used herein, plus 300 (e.g., headband 404 includes a top strap 512, a pair of opposing side arms 514, a yoke 516, and a rear strap 518). The top strap 512 and the rear strap 518 form a forked configuration.

[0267] The side arm 514 and / or top strap 512 may include a core 549 and a housing 551. In some embodiments, the core is made of or comprises a plastic material. In some embodiments, the housing is or comprises a textile. The housing may be permanently bonded to the core. A textile housing may advantageously provide a soft and comfortable finish for contact with the user during use. The longitudinal edge portions of the housing 551 that protrude from the edge of the core 549 and are not filled by the core 549 may form a soft edge 550, such as... Figure 37 As shown in the illustration. The soft edge 550 can advantageously provide a cushioned edge that can improve user comfort, for example by softening the potential contact between the edge of the top strap 512 and / or the edge of the side arm 514 and the user's head. In some cases, having a cushioned edge may be particularly beneficial for the lower edge of the side arm 514, which is located above the user's ear during use. The thickness of the soft edge 550 can vary along the length of each side arm 514. In the illustrated embodiment, the thickness of the soft edge 550 is a maximum of 2 mm or approximately 2 mm (by...) at the lateral ends of the side arm 514. Figure 37 The change in D2 (represented in the text) is a minimum of 1 mm or approximately 1 mm at the upper ridge of yoke 516 (by...). Figure 37 (D1 in the text represents this). In some embodiments, the lower edge of the yoke 516 does not include a soft edge, for example, because: for aesthetic and / or industrial design benefits, the lower edge of the yoke 516 is not intended to come into contact with the user's face during use, to allow for tolerances between multiple parts; and / or for other reasons. Omitting the soft edge in this area provides additional space to allow for increased thickness of the core 549 of the yoke 516, thereby improving or increasing the structural integrity of this area.

[0268] In the illustrated embodiment, the outer shell 551 is made of a textile, which is an unstretched or low-stretch yarn. Unstretched or low-stretch yarns require relatively high forces to undergo elastic deformation. In some cases, highly elastic yarns perform poorly (or worse than less elastic yarns) during the internal molding process used to form the top strap 512 and / or side arms 514 because the yarn fibers can stretch to the extent that molten plastic can escape from the shell. Using unstretched or low-stretch yarns for the shell of the side arms 514 advantageously improves the finish and / or consistency of the final side arms 514. Unstretched or low-stretch yarns reduce or minimize the amount or extent to which the yarn fibers can stretch, which can prevent or reduce the possibility of plastic stretching and escaping from the textile shell during the internal molding process. Therefore, using unstretched or low-stretch yarns can also help improve the reliability of the manufacturing process. In some embodiments, the textile shell may be made of or may include yarns with a degree of elasticity. Yarns with low elasticity (i.e., requiring relatively high force to achieve elastic stretching) can play a significant role in the molding process. In some embodiments, the gate 501 for the molding process is located at or near the center point of the yoke 516 of the headband 404, such as... Figure 35B As shown.

[0269] As described herein, frame 410 may include headband retaining features 450 in the form of holes, these retaining features being designed to receive protrusions 515 of headband 404. Figure 35A As shown, the protrusions 515 (also referred to herein as frame retaining features) can be located on either side of the yoke 516. In the illustrated embodiment, each of the protrusions 515 includes two retaining portions 517 separated by a channel 519, as... Figure 35A as well as Figures 36A-36B As shown. Channel 519 is formed by a protrusion 619 in the molding tool 600, which fills the area forming channel 519, as... Figure 36C As shown. During molding, the molten plastic is forced under pressure to pass through the housing 551, or is allowed to exit the housing 551 to form a retaining portion 517. The protrusion 619 of the molding tool 600 also constrains the fabric or material of the housing 551 to prevent or inhibit the fabric or material of the housing 551 from expanding beyond the base of the channel 519 as the plastic exits, thereby forming the retaining portion 517, as shown. Figure 36CAs indicated by 553 in the diagram. The housing 551 may also be constrained in other ways, or alternatively, in other ways. For example, if the retaining portion 517 (and / or other protrusions from the housing 551) has a thin profile or dimension relative to the outline or size of the textile housing 551, the housing 551 may not protrude significantly over the protrusions. This advantageously prevents or inhibits deformation of the housing 551 and / or helps ensure that the retaining portion 517 comprises only plastic, or is made only of plastic. Having a retaining portion 517 made only or primarily of plastic, rather than including a housing, can advantageously improve the function of the frame retaining feature 515, for example, by allowing the frame retaining feature 515 to snap more securely into the headband retaining feature 450. The channel 519 may also, or alternatively, allow the retaining portions 517 to bend relative to each other to improve the performance of the frame retaining feature 515, for example, to allow the frame retaining feature 515 to bend to snap into the headband retaining feature 450.

[0270] like Figure 38A As shown, each side arm 514 includes a buckle 526. The buckle 526 is formed from an extension of the free end of the side arm 514 and includes an opening 527 extending through the thickness of the side arm 514. The opening 527 is configured to receive a rear strap 518. In the illustrated embodiment, the buckle 526 is integrally formed with the side arm 514. In some embodiments, the structure of the buckle 526 may be held by a core 549, and the housing 551 may make the buckle 526 feel soft to the touch. The buckle can be formed by internally molding the entire buckle structure with a complete plastic core, including determining the location of the opening 527 and then die-cutting the opening 527. Alternatively, the opening 527 can be formed during an internal molding process, wherein the housing 551 of the side arm 514 splits into two tubes at the end of the side arm 514 adjacent to the opening 527, and then these tubes recombine on opposite sides of the opening 527. In some embodiments, the buckle 526 may be formed of plastic (or other core 549 material) extending beyond one end of the housing 551, such that the buckle 526 does not include the housing 551. In some embodiments, the flexible edge 550 of the side arm 514 extends at the top and bottom of both the side arm 514 and the buckle 526, and the lateral end 525 of the buckle 526 does not include the flexible edge 550, for example, as... Figure 38B As shown. In the illustrated embodiment, when the headband 404 is laid flat, the buckle 526 is coplanar with or aligned with the side arm 514. In some embodiments, the buckle 526 is offset from the side arm 514 during use, for example, offset away from or toward the user.

[0271] Similar to headband 204, the top strap 512 of headband 404 includes a first (or left) portion 520 and a second (or right) portion 522, as... Figures 39 to 40As shown. The first part 520 and the second part 522 are separate from each other. Each of the first part 520 and the second part 522 has a free end and a fixed end. The fixed end extends at an angle to the side arm 514 at the connection 524. The free end is configured for adjustable connection via an adjustment mechanism 528. The adjustment mechanism 528 allows the top strap 512 to be adjusted and fixed at the desired length.

[0272] like Figures 39 to 41 As shown, the free end of the second portion 522 includes a guide ring 530, and the second portion 522 includes a plurality of holes 532 spaced apart near the free end along the length of the second portion 522. In the illustrated embodiment, the guide ring 530 is plastic. The guide ring 530 can be formed by a breakthrough molding process. “Breakthrough molding” is described in the applicant’s co-pending applications US 62 / 309,400, US 62 / 323,459, US 62 / 364,767, and US 62 / 401,462. Breakthrough molding is a variation of internal molding as described above. The breakthrough molding process involves introducing molten plastic into a textile shell and then pushing the molten plastic through a portion of the textile shell. The component formed by the breakthrough molding process includes an integral plastic core integrally formed with the textile shell, the integral plastic core having a portion extending through the textile shell. In some embodiments, the guide ring 530 may be coupled to the free end of the second portion 522. In some embodiments, the guide ring 530 includes a housing, such as an extension of a housing 551. In some embodiments, the guide ring 530 is made only of the housing material and not of plastic (or other core material), or includes only the housing material and does not include plastic (or other core material). The first portion 520 includes a protrusion 534 that protrudes from the inner surface of the first portion 520 (i.e., the surface of the first portion 520 facing the second portion 522 in use) near its free end. The first portion 520 may also include a plurality of position indicators. To adjust and / or secure the first portion 520 and the second portion 522 relative to each other, the free end of the first portion 520 is passed through the guide ring 530, and then the protrusion 534 is passed through one of the holes 532 and / or secured in that hole (e.g., via a snap-fit ​​connection).

[0273] The hole 532 can be formed using a breakthrough internal molding process. In some embodiments, the housing 551 of the second portion 522 can be divided into two parallel (and closed) housing portions adjacent to the first hole 532 (i.e., the hole 532 closest to the connection portion 524) (on the side of the connection portion 524 of the first hole), and these parallel housing portions can extend along the length of the second portion 522 including the hole 532. These parallel housing portions can be reassembled into a single housing after the last hole 532 (i.e., the hole 532 furthest from the connection portion 524) (or on the free end side of the hole). These parallel housing portions can be bent toward each other between the holes 532, such that gaps in the fabric or material of the housing 551 are not easily observed by the user. In some embodiments, these parallel housing portions are not reassembled after the last hole 532. In some such embodiments, pressure from the plastic or core 549 material can force these parallel housing portions to move closer together after the last hole 532, making gaps in the fabric less observable. In some embodiments, the housing 551 includes a hole 532, and the molding tool is designed to restrict the flow of molten plastic (or other core 549 material) into the hole 532 during molding. In some embodiments, the second portion 522 may be internally molded without the hole 532, and the hole 532 may then be formed via post-processing (e.g., via die-cutting). In some embodiments, the housing 551 may terminate near or adjacent to the first hole 532 (on the connection 524 side of the first hole), and the remainder of the second portion 522 may be formed using a breakthrough process to include only plastic (or other core 549 material).

[0274] In some embodiments, each hole 532 is at least partially surrounded by a surrounding channel 533 (on one or both of the inner and outer surfaces of the second portion 522). The surrounding channel 533 may assist in forming the hole 532 via internal molding. The molding tool may include a protrusion that applies pressure to the housing 551 during molding of the channel 533. This molding tool protrusion may restrict movement of the housing 551 during molding. Restricting movement of the housing 551 advantageously helps ensure that the periphery of the hole 532 (in other words, the structure within the boundary of the surrounding channel 533, made of plastic or other core 549 material) is entirely or substantially entirely made of plastic (or other core 549 material). A periphery of the hole 532 that is entirely made of plastic (or other core 549 material) may improve the function of the adjustment mechanism 528 and / or help maintain the tolerances associated with the hole 532.

[0275] In some embodiments, each of the first portion 520 and the second portion 522 of the top strap 512 is integrally formed with the adjacent side arm 514 (e.g., via a breakthrough internal molding process). In some embodiments, each of the first portion 520 and the second portion 522 is a separate component that is permanently or removably coupled or connected to the corresponding side arm 514. For example, as Figure 42 As shown, each side arm 514 includes a connecting portion 524 comprising a connecting protrusion 560. The connecting protrusion 560 may be formed during molding of the side arm 514 (e.g., using a breakthrough internal molding process). Each of the first portion 520 and the second portion 522 of the top strap 512 includes a recessed surface 562 at or near the connecting end. The contour of the recessed surface 562 is opposite (or substantially opposite) to, or corresponds to, the contour of the connecting protrusion 560. After molding, each of the connecting protrusions 560 is inserted into the housing 551 of the connecting end of the corresponding first portion 520 or second portion 522 of the top strap 512 and positioned within the recessed surface 562. Each side arm 514 and the corresponding one of the first portion 520 and the second portion 522 may then be welded together, for example, using ultrasonic welding, radio frequency welding, or other suitable methods. After welding, the side arm 514 and the top strap 512 form a single plastic (or other core material) component. The housing 551 of the top strap 512 can be welded to the housing 551 of the side arm 514. In some embodiments, the area of ​​the top strap 512 adjacent to the connecting portion 524 does not include the flexible edge 550. In such embodiments, the housings 551 are adequately secured together by welding the cores 549 of both the side arm 514 and the top strap 512 without welding the housings 551 of both the side arm 514 and the top strap 512. In some embodiments, the thickness of the connecting protrusion 560 is approximately the same as the thickness of the rest of the core 549 of the side arm 514. In some embodiments, the connecting protrusion 560 has a reduced thickness. In some embodiments, the connecting protrusion 560 is offset from the central plane of the side arm 514. When the connecting protrusion 560 is seated in the recessed surface 562, the reduced thickness and offset of the connecting protrusion 560 allow the cores 549 of both the side arm 514 and the top strap 512 to be flush with the boundary between the connecting protrusion 560 and the recessed surface 562.

[0276] In some embodiments, the first portion 520 of the top strap 512 includes a positioning guide 570 to help the user set and maintain a specific headband setting, length, or size. Figures 43A-43BAs shown, the positioning guide 570 may include a series of protruding edges 572. The central portion 574 of the first portion 520 has a reduced lateral profile compared to the protruding edges 572. The protruding edges 572 have a profile or width slightly larger than the diameter or width of the guide ring 530. Therefore, the contact and interaction between the protruding edges 572 and the guide ring 530 provides friction or resistance as the first portion 520 slides through the guide ring 530 of the second portion 522. This resistance can prevent the first portion 520 from passively moving through the guide ring 530, or reduce the likelihood of such passive movement. Thus, the user can disengage the protrusion 534 from the hole 532, and the resistance can then help resist relative movement between the first portion 520 and the second portion 522 to maintain the length of the strap 512 unless the user applies sufficient force to overcome the resistance. In the illustrated embodiment, the protruding edges 572 are outwardly projecting curved or dome-shaped. Other shapes or configurations for the protruding edges 572 are also possible. For example, the protruding edge 572 can be triangular.

[0277] Figures 44 to 45 Another non-limiting exemplary embodiment of a breathing mask assembly 600 is shown. The breathing mask assembly 600 includes a patient interface and a headband 604. The patient interface includes a seal 606 configured to connect to a frame 610 and a gas delivery conduit 608. The frame 610 is similar to and / or includes some or all of the features of a frame 410. The headband 604 and the frame 610 are configured to secure the seal 606 in a stable position below the user's nose during use. Figures 46 to 47A , Figure 47B An exemplary embodiment of a headband 604 used with a frame 610 is shown. In the illustrated embodiment, the headband 604 has a forked configuration. The headband 604 is similar in some respects to the headband 404; for example, the headband 604 has the same or similar overall shape as the headband 404 and includes a top strap 612, a pair of opposing side arms (or bottom or top straps) 614, a yoke 616, and a rear strap 618. The top strap 612 and the rear strap 618 form a forked configuration. In some embodiments, one or more of the top strap 612, the bottom strap 614, and the yoke 616 and / or the rear strap 618 have a different color than one or more of the other straps.

[0278] The side arm 614 and / or top strap 612 include a core and a shell, such as a headband 504. In some embodiments, the core is made of or comprises a plastic material. In some embodiments, the shell is textile or comprises textile.

[0279] The top strap 612 of the headband 604 includes a first (or left) portion 620 and a second (or right) portion 622, as shown below. Figures 47A-49B As shown. The first portion 620 and the second portion 622 are separate from each other. Each of the first portion 620 and the second portion 622 has a free end and a fixed end. The fixed end extends from the front strap 614, for example, at an angle. In the illustrated embodiment, the first portion 620 of the front strap 614 and the second portion 622 of the top strap 612 can be formed independently of each other via internal molding and then connected together via an overmolded joint. As shown, each of the first portion 620 and the second portion 622 is connected to the front strap 614 via an overmolded joint 624.

[0280] The free ends of both the first portion 620 and the second portion 622 of the top strap 612 are configured to be adjustablely connected via an adjustment mechanism 628. The adjustment mechanism 628 allows the top strap 612 to be adjusted and secured to a desired length. The adjustment mechanism 628 includes interlocking portions disposed on the respective first portion 620 and second portion 622 of the top strap. These interlocking portions selectively engage in one of a variety of discrete configurations to set the length of the top strap 612. When these interlocking portions are engaged, the first portion 620 and the second portion 622 of the top strap are in a partially overlapping configuration. In this overlapping configuration, a portion of the inner surface of the first portion 620 of the top strap covers a portion of the outer surface of the second portion 622 of the top strap. The inner surface of the first portion 620 of the top strap faces the user during use, and the outer surface of the second portion 622 of the top strap faces away from the user during use. These interlocking portions can disengage and re-engage in different configurations to facilitate adjustment of the length of the top strap. For different lengths of the top strap 612, the first portion 620 and the second portion 622 overlap by different lengths or to different degrees. In the illustrated embodiment, the mating portion of the first portion 620 includes a male connector 628a, and the mating portion of the second portion 622 includes a female connector 628b; however, in some embodiments, the mating portion of the first portion 620 includes a female connector, and the mating portion of the second portion 622 includes a male connector.

[0281] like Figures 47A-48BAs shown, the free end of the second portion 622 includes a guide ring 630. The interlocking portions of the second portion 622 include a plurality of recesses in the form of holes 632, these holes being spaced apart along the length of the second portion 622 near the free end. As illustrated, each of the holes 632 extends through the second portion 622 of the top strap 612. In other embodiments, the interlocking portions of the second portion 622 include recesses that extend through the second portion of the top strap into it. Figure 47A , Figure 49B and Figure 50B As shown, the engaging portions of the first portion 620 of the top strap include a protrusion 634 that protrudes from the inner surface of the first portion 620 near its free end. To adjust and / or secure the first portion 620 and the second portion 622 relative to each other, the free end of the first portion 620 is passed through a guide ring 630, and then the protrusion 634 is inserted into and / or secured in one of the holes 632 (e.g., via a snap-fit ​​connection).

[0282] In the illustrated embodiment, the mating portions of the adjustment mechanism 628 (i.e., the male connector 628a and the female connector 628b) are not covered by the housing. This can advantageously provide a cleaner finish (e.g., concealing loose wire ends) and / or reduce manufacturing difficulty.

[0283] like Figures 50A-50C As shown, the first portion 620 of the top strap is provided with or included in the outer surface of the first portion (i.e., the surface opposite to the second portion of the top strap and the user 622 in use) and / or therein (e.g., on the outer surface and / or therein of the male connector 628a). The thumb gripper 629 is provided on the side of the first portion 620 of the top strap opposite to or opposite to the protrusion 634. The thumb gripper 629 may include a recessed portion (e.g., as shown in the image). Figure 50C (as shown) and / or raised ribs (e.g., as shown) Figure 50A(The raised ring shown). The first portion 620 is provided with or includes a finger gripper 631 on the inner surface of the top strap first portion 620 and / or therein (e.g., on the inner surface of the male connector 628a and / or therein). In the illustrated embodiment, the finger gripper 631 includes a recessed or recessed portion. The finger gripper 631 is located on the top strap first portion, extending beyond the protrusion 634 or distal to the protrusion (i.e., toward the free end). The finger gripper 631 is located on the same or opposite side of the top strap first portion 620 as the thumb gripper 629. Thus, the finger gripper 631 is located on the opposite or opposite side of the top strap first portion 620 as the thumb gripper 629. The thumb gripper 629 and / or the finger gripper 631 advantageously allow the user to more easily grip the male connector 628a. The thumb gripper 629 and / or finger gripper 631 further, or alternatively, provide the user with visual and / or tactile cues on how to grip and use the adjustment mechanism 628, which improves ease of use. The indented or recessed portion of the finger gripper 631 thins or reduces the thickness of that portion of the first portion 620 of the top strap. This thinning allows for greater flexibility in the interlocking portions of the first portion 620 of the top strap, advantageously allowing the user to untie the interlocking portions. For example, the user can more easily bend and / or lift the male connector 628a away from the female connector 628b. In use, the thumb gripper 629 can be gripped by the user's thumb or finger, and / or the finger gripper 631 can be gripped by the user's thumb or finger, depending on which is more comfortable for the user. Figure 51A The demonstration showed a user gripping the finger gripper 631 with their fingers and the thumb gripper 629 with their thumb. Figure 51B The illustration shows a user gripping the finger gripper 631 with their thumb and the thumb gripper 629 with their fingers. In this respect, the thumb gripper 629 and the finger gripper 631 are the first and second grippers, which can be interchangeably engaged by the user's thumb and fingers to hold the free end of the first portion of the top strap therebetween.

[0284] As described above, the front strap 614, the first portion 620 of the top strap 612, and the second portion 622 of the top strap 612 are formed independently of each other via internal molding, and then connected together via an overmolded joint 624. Figures 52A to 52B As shown, the top strap 612 includes at least one alignment post 660 (e.g., two alignment posts 660a in the illustrated embodiment) near each of the fixed ends. Figures 53A to 53BAs shown, the bottom strap 614 includes at least one alignment post 660 (e.g., two alignment posts 660b in the illustrated embodiment) near each end. The bottom strap 614 includes at least one alignment post 660 (e.g., one alignment post 660c in the illustrated embodiment) positioned in each of two tabs 662 extending from the upper or top edge of the bottom strap 614. In some embodiments, the tabs 662 are formed via a breakthrough process. The alignment post 660 protrudes through the housing on the inner and / or outer surfaces of the top strap 612. The alignment post 660 abuts the inner surface of the overmolding tool cavity to assist in the alignment and positioning (e.g., in the thickness direction) of the ends of both the first portion 620 and the second portion 622 relative to the front strap 614 within the overmolding tool during manufacturing. The alignment post 660 also, or alternatively, increases the surface area of ​​the top strap 612 available for bonding with the overmolding material.

[0285] The top strap 612 and / or the bottom strap 614 include one or more pin holes 664 that extend partially from the inner surface of the strap into the thickness of the strap. In the illustrated embodiment, a first portion 620 and a second portion 622 of the top strap 612 each include a pin hole 664 near a fixed end, and the bottom strap 614 includes a pin hole 664 near each end and a pin hole 664 near each breakout tab 662. The pin holes 664 are designed to receive pins that form part of the overmolding tool during manufacturing. The pins and pin holes 664 engage with each other to hold the strap in a predetermined position within the overmolding tool and to inhibit movement of the strap within the overmolding tool, for example, when an overmolding material (e.g., plastic) is injected into the tool.

[0286] During manufacturing, each of the fixed ends of both the first portion 620 and the second portion 622 is aligned with one of the breakthrough tabs 662, as follows: Figures 54A to 55B As shown, the protruding tab 662, the fixed end of the top strap 612, and / or the end of the bottom strap 614 include a recess 666 in the outer and / or inner surfaces. The recess 666 advantageously provides an increased thickness of the overmolding material in the overmolding joint 624, such as... Figure 57 As shown, and / or an enlarged surface area for bonding the overmolding material, to improve the mechanical connection between the overmolded joint and the strap, thereby strengthening the joint 624. Figures 54A to 55B As shown, the breakout tab 662 can have a reduced thickness compared to the thickness of the body of the bottom strap 614. This reduced thickness forms a recess for filling the overmolding material and allows the final overmolding joint 624 to have the same or similar thickness as the bodies of the bottom strap 614 and / or the top strap 612, as... Figure 56A-58 As shown. This inhibits the formation of protrusions that could exert force or pressure on the user's head and cause discomfort. In some embodiments, the alignment post 660 has the same or similar thickness as the overmolded joint 624, for example, as Figure 57 As shown. In such embodiments, the alignment post 660 may leave a positioning mark 661 in the overmolded joint 624. In some embodiments, the overmolded joint 624 overlaps with the edge of the bottom strap 614, for example, as Figures 56A-56B As shown. This improves the strength of the joint 624 between the top strap 612 and the bottom strap 614. The overmolded joint 624 advantageously provides improved strength to the joint between the top strap 612 and the bottom strap 614, and also provides a cleaner and more aesthetically pleasing finish (e.g., compared to an internally molded connection).

[0287] Figure 59 An example embodiment of a variation of the geometry of the alignment post 660 is shown. In the illustrated embodiment, the alignment post is conical. This shape reduces or minimizes the position markers on the final overmolded joint 624. The distal end or surface of the alignment post 660 (the end or surface of the alignment post 660 facing away from the strap body) has a reduced diameter, which provides a smaller contact area with the inner surface of the overmolding tool cavity. This allows the overmolding material to cover a larger area of ​​the alignment post 660, thereby reducing the size of the position markers, while still allowing one or more straps to be positioned vertically within the overmolding tool.

[0288] like Figure 50C and Figure 58 As shown, each of the first and second portions of the top strap has a textile-covered portion and an exposed portion or plastic portion that joins with the interlocking portions. Each textile-covered portion can be prepared by internal molding as described above. Each textile-covered portion has a tab, onto which the corresponding exposed portion is overmolded.

[0289] like Figures 47A-49B as well as Figures 56A-56B As shown, a buckle or rear strap connector 626 can be overmolded onto each end of the bottom strap 614. Each buckle 626 includes an opening 627 configured to receive the rear strap 618. In the illustrated embodiment, the buckle 626 is not covered by a housing. Because the overmolded buckle 626 has a lower coefficient of friction than a textile-covered buckle, the overmolded buckle 626 allows the rear strap 618 to be pulled more easily over the buckle 626 during assembly and / or adjustment.

[0290] like Figure 64As shown, each buckle 626 has a width W2 greater than the width W1 of the bottom strap 614, allowing the rear strap 618 (which has substantially the same width as the bottom strap 614) to pass through the opening 627 of the buckle 626. The upper edge 626a of each buckle 626 is offset from the upper edge 614a of the bottom strap 614. However, the lower edge 626b of the buckle 626 is aligned with the lower edge 614b of the bottom strap 614. This provides a smooth and continuous lower edge for the headband, reducing the likelihood of the headband digging into the user's ears when worn. The width of the opening 627 of the buckle 626 is substantially equal to the width of the rear strap 618. In some embodiments, the rear strap 618 has substantially the same width as the bottom strap 614.

[0291] Similar to frame 410 and headband 404, frame 610 includes headband retaining features 650 in the form of holes, these retaining features being designed to receive protrusions 615 of headband 604. Figures 60A-62A As shown, the protrusion 615 (also referred to herein as a frame retaining feature) can be located on either side of the yoke 616. In the illustrated embodiment, the protrusion 615 has a horseshoe-shaped or "U"-shaped cross-section, and an inlet 619 extends from the perimeter of the protrusion 615 toward the center of the protrusion 615, extends to the center of the protrusion, and / or extends through the center of the protrusion. The inlet 619 allows the protrusion 615 to bend so that the protrusion 615 can snap into and / or exit the headband retaining feature 650.

[0292] In some embodiments, such as Figure 63As shown, the bottom strap 614 includes a thumb pad 652 that extends laterally outward (towards the ends of both the bottom strap 614 and the buckle 626) around each of the frame retaining features 615 and / or from each of these frame retaining features. The thumb pad 652 is thicker than the surrounding portion or the remainder of the bottom strap 614. The thumb pad 652 advantageously provides increased strength and / or elasticity to the yoke 616, making it less likely to permanently deform and / or become fatigued due to repeated removal from and / or reattachment to the frame 610. The thumb pad 652 also, or alternatively, provides a visual indication to the user to grasp the headband 604 at this location (at the thumb pad 652) to disconnect the headband 604 from the frame 610 and / or attach the headband 604 to the frame. In the illustrated embodiment, the frame retaining feature 615 is oriented such that the inlet 619 (i.e., the opening of the inlet 619 within the circumference of the frame retaining feature 615) faces laterally outward (or toward the ends of both the bottom strap 614 and the buckle 626). Thus, the inlet 619 is aligned with the extended portion of the thumb pad 652, which may be more aesthetically pleasing. In some embodiments, the thumb pad 652 provides an enhanced visual indicator within the textile housing in the form of a region with a different color and / or texture. In some embodiments, the region with a different color and / or texture is integrally formed with the remainder of the textile housing.

[0293] Unless the context clearly requires otherwise, the terms “comprising,” “including,” etc., used throughout this specification and claims should be understood to have an inclusive meaning (as opposed to an exclusive or exhaustive meaning), that is, to mean “including but not limited to.” In the foregoing description, references have been made to components, either in whole or having known equivalents thereof, which are incorporated herein as if individually stated.

[0294] The disclosed methods, apparatus and systems may also be broadly defined as including the parts, elements and features individually or jointly mentioned or indicated in this disclosure, as well as any combination or all combinations of two or more of said parts, elements or features.

[0295] Any reference to prior art in this specification is not and should not be construed as an admission that such prior art constitutes part of common knowledge in any country in the world, or as a suggestion of any kind.

[0296] As used herein, the terms “approximately,” “about,” “generally,” and “substantially” mean a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic and still performs the desired function or achieves the desired result. Deviation from the stated value, quantity, or characteristic may, for example, reflect acceptable tolerances, conversion factors, rounding, measurement errors, or other factors known to those skilled in the art. For example, the terms “generally parallel” and “substantially parallel” refer to a value, quantity, or characteristic that may deviate from perfect parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or other degrees.

[0297] Although this disclosure has been described with reference to certain embodiments, it will be apparent to those skilled in the art that other embodiments are also within the scope of this disclosure. Therefore, various changes and modifications can be made without departing from the spirit and scope of this disclosure. For example, various components may be repositioned as needed. Furthermore, not all features, aspects, and advantages are necessary for carrying out this disclosure. Therefore, the scope of this disclosure is intended to be defined solely by the following claims.

Claims

1. A frame for a respiratory mask, the frame comprising: a main body comprising an outer surface and an inner surface; the outer surface comprising a yoke receiving structure configured to receive a yoke, wherein the yoke receiving structure spans a longitudinal distance of the main body, the outer surface further comprising an inlet collar defining an inlet; the inner surface comprising an outlet collar defining an outlet, wherein a gas passageway is formed between the inlet and the outlet, and a circumference of the gas passageway at the inlet is less than a circumference of the gas passageway at the outlet.

2. The frame of claim 1, wherein, the inlet collar comprises a portion of increased circumference.

3. The frame of claim 1 or 2, wherein, the inlet and / or the outlet comprises an elliptical shape.

4. The frame of claim 3, wherein, the inlet collar is elliptical having a major axis and a minor axis, the frame being symmetrical about the minor axis.

5. The frame of claim 1, wherein, the inlet defined by the inlet collar has a major dimension and a minor dimension, the major dimension having a length greater than a length of the minor dimension.

6. The frame of claim 5, wherein, a ratio of the major dimension to the minor dimension is from 1:1 to 2:

1.

7. The frame of claim 6, wherein, a ratio of the major dimension to the minor dimension is 1.2:

1.

8. The frame of claim 1, wherein, the inlet collar further comprises a conduit retaining protrusion and / or one or more vent holes.

9. The frame of claim 1, wherein, the outlet collar comprises at least one seal retaining recess.

10. The frame of claim 1, wherein, the inlet collar comprises a first portion having a first outer circumference, a second portion coaxially offset from the first portion and having a second outer circumference, and a transition portion integral with the first portion and connecting the first portion to the second portion.

11. The frame of claim 10, wherein, the second outer circumference of the second portion is greater than the first outer circumference of the first portion, and the second portion is displaced relative to the first portion proximally when the respiratory mask is worn by a user.

12. The frame of claim 10 or 11, wherein, the inlet collar has an angled surface and / or a combination of an angled surface and a surface that is not angled relative to an inlet proximal axis.

13. The frame of claim 12, wherein, an angle of the angled surface relative to the inlet proximal axis is between 0° and 20°.

14. The frame of claim 13, wherein, an angle of the angled surface relative to the inlet proximal axis is between 5° and 15°.

15. The frame of claim 12, wherein, the angled surface comprises at least one vent hole.

16. The frame of claim 8, wherein, the conduit retaining protrusion protrudes inwardly from a periphery of the inlet collar.

17. The frame of claim 16, wherein, the conduit retaining protrusion forms a lip around an interior of a distal end of the inlet collar.

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